Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373102|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373103|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373104|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373105|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373106|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373107|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373108|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373109|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373110|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373111|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373112|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373113|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373114|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373115|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373116|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373117|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373118|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373119|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373592|NCT01059760|O3|Outcome|Change When Fed|
373593|NCT01059760|O2|Outcome|Change While Fasting|
373120|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373121|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373122|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373123|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373124|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373125|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373126|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373127|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373128|NCT01060059|E2|Reported Event|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
373129|NCT01060059|E1|Reported Event|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
373130|NCT01060020|B1|Baseline|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373131|NCT01060020|P1|Participant Flow|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373132|NCT01060020|O1|Outcome|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373133|NCT01060020|O1|Outcome|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373134|NCT01060020|O1|Outcome|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373135|NCT01060020|O1|Outcome|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373136|NCT01060020|O1|Outcome|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373137|NCT01060020|E1|Reported Event|Sildenafil 40mg or 80mg|"A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab.~Sildenafil: Single oral dose of 40mg or 80mg of Sildenafil"
373138|NCT01060007|B1|Baseline|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373139|NCT01060007|P1|Participant Flow|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373140|NCT01060007|O3|Outcome|1 Year Post-treatment|
373141|NCT01060007|O2|Outcome|Pre-surgery|
373142|NCT01060007|O1|Outcome|Pre-treatment|
373143|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373144|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373145|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373146|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373147|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373148|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373149|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373150|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373151|NCT01060007|E1|Reported Event|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
373152|NCT01059994|B5|Baseline|Total|Total of all reporting groups
373153|NCT01059994|B4|Baseline|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
373154|NCT01059994|B3|Baseline|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
373155|NCT01059994|B2|Baseline|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
373156|NCT01059994|B1|Baseline|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
373157|NCT01059994|P4|Participant Flow|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
373158|NCT01059994|P3|Participant Flow|Sildenafil Placebo Older|Sildenafil placebo: Oral, daily, 1 week.
373159|NCT01059994|P2|Participant Flow|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
373160|NCT01059994|P1|Participant Flow|Sildenafil Placebo Young|Sildenafil placebo: Oral, daily, 1 week.
373161|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
373162|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
373163|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
373164|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
373165|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
373166|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
373167|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
373168|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
373169|NCT01059994|E4|Reported Event|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
373170|NCT01059994|E3|Reported Event|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
373171|NCT01059994|E2|Reported Event|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
373172|NCT01059994|E1|Reported Event|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
373173|NCT01059903|B3|Baseline|Total|Total of all reporting groups
373594|NCT01059760|O1|Outcome|Baseline Value|
373174|NCT01059903|B2|Baseline|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
373175|NCT01059903|B1|Baseline|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
373176|NCT01059903|P2|Participant Flow|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
373177|NCT01059903|P1|Participant Flow|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
373178|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373179|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373180|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373181|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373182|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373183|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373184|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373185|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373186|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373187|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373188|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373189|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373190|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373191|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373192|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373193|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373194|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373195|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373196|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373197|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373198|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373199|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373200|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373201|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373202|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373203|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373204|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373205|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373206|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373207|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373208|NCT01059903|E2|Reported Event|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
373209|NCT01059903|E1|Reported Event|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
373210|NCT01059864|B1|Baseline|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
373211|NCT01059864|P3|Participant Flow|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373595|NCT01059760|O3|Outcome|Change When Fed|
373212|NCT01059864|P2|Participant Flow|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373213|NCT01059864|P1|Participant Flow|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
373214|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373215|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373216|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373217|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373218|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373219|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373220|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373221|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373222|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373223|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373224|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373225|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373226|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373227|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373228|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373229|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373230|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373231|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373232|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373233|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373234|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373235|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373236|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373237|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373238|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373239|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373240|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373241|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373242|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373243|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373244|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373245|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373246|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373247|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373248|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373249|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373250|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373251|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373252|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373253|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373254|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373289|NCT01059825|P5|Participant Flow|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373255|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373256|NCT01059864|E3|Reported Event|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373257|NCT01059864|E2|Reported Event|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
373258|NCT01059864|E1|Reported Event|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
373259|NCT01059851|B3|Baseline|Total|Total of all reporting groups
373260|NCT01059851|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
373261|NCT01059851|B1|Baseline|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
373262|NCT01059851|P6|Participant Flow|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373263|NCT01059851|P5|Participant Flow|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373264|NCT01059851|P4|Participant Flow|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373265|NCT01059851|P3|Participant Flow|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373266|NCT01059851|P2|Participant Flow|Healthy Participants (Severe Impairment Controls) (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
373267|NCT01059851|P1|Participant Flow|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
373268|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
373269|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
373270|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
373271|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
373272|NCT01059851|O4|Outcome|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373273|NCT01059851|O3|Outcome|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373274|NCT01059851|O2|Outcome|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373275|NCT01059851|O1|Outcome|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
373276|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
373277|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
373278|NCT01059851|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
373279|NCT01059851|E1|Reported Event|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
373280|NCT01059825|B7|Baseline|Total|Total of all reporting groups
373281|NCT01059825|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373282|NCT01059825|B5|Baseline|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373283|NCT01059825|B4|Baseline|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373284|NCT01059825|B3|Baseline|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373285|NCT01059825|B2|Baseline|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373286|NCT01059825|B1|Baseline|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373287|NCT01059825|P7|Participant Flow|Metformin Run-in|Participants received open-label metformin during the run-in period.
373288|NCT01059825|P6|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373290|NCT01059825|P4|Participant Flow|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373291|NCT01059825|P3|Participant Flow|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373292|NCT01059825|P2|Participant Flow|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373293|NCT01059825|P1|Participant Flow|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373294|NCT01059825|O7|Outcome|Metformin Run-in|Participants received open-label metformin during the run-in period.
373295|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373296|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373297|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373298|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373299|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373300|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373301|NCT01059825|O7|Outcome|Metformin Run-in|Participants received open-label metformin during the run-in period.
373302|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373303|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373304|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373305|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373306|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373307|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373308|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373309|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373310|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373311|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373312|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373313|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373314|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373315|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373316|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373317|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373318|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373319|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373320|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373321|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373322|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373323|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373324|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373325|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373326|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373327|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373328|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373329|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373330|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373331|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373335|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373336|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373337|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373338|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373339|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373340|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373341|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373342|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373343|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373344|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373345|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373346|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373347|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373348|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373349|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373350|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373351|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373352|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373353|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373354|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373355|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373356|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373357|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373358|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373359|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373360|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373361|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373362|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373363|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373364|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373365|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373366|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373367|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373368|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373369|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373370|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373371|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373372|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373373|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373374|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373375|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373376|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373377|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373378|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373379|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373380|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373381|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373382|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373383|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373384|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373385|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373386|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373387|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373388|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373389|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373390|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373391|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373392|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373393|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373394|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373395|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373396|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373397|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373398|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373399|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373400|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373401|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373402|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373403|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373404|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373405|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373406|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373407|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373408|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373409|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373410|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373411|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373412|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373413|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373414|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373415|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373416|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373417|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373418|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373419|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373420|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373421|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373422|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373423|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373424|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373425|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373426|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373427|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373428|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373429|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373430|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373431|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373432|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373433|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373434|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373435|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373436|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373437|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373438|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373439|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373440|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373441|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373442|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373443|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373444|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373445|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373446|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373447|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373448|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373449|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373450|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373451|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373452|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373453|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373454|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373455|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373456|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373457|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373458|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373459|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373460|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373461|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373462|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373463|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373464|NCT01059825|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373465|NCT01059825|O5|Outcome|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373466|NCT01059825|O4|Outcome|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373467|NCT01059825|O3|Outcome|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373468|NCT01059825|O2|Outcome|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373469|NCT01059825|O1|Outcome|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373470|NCT01059825|E7|Reported Event|Metformin Run-in|Participants received open-label metformin during the run-in period.
373471|NCT01059825|E6|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
373472|NCT01059825|E5|Reported Event|Ertugliflozin 25 mg|Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
373473|NCT01059825|E4|Reported Event|Ertugliflozin 10 mg|Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373474|NCT01059825|E3|Reported Event|Ertugliflozin 5 mg|Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373475|NCT01059825|E2|Reported Event|Ertugliflozin 1 mg|Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
373476|NCT01059825|E1|Reported Event|Placebo|Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
373477|NCT01059812|B3|Baseline|Total|Total of all reporting groups
373478|NCT01059812|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373479|NCT01059812|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373480|NCT01059812|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373481|NCT01059812|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373482|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373483|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373484|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373485|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373486|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373487|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373488|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373489|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373490|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373491|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373492|NCT01059812|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373493|NCT01059812|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
373494|NCT01059799|B3|Baseline|Total|Total of all reporting groups
373495|NCT01059799|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373496|NCT01059799|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373497|NCT01059799|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373498|NCT01059799|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373499|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373596|NCT01059760|O2|Outcome|Change While Fasting|
373500|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373501|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373502|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373503|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373504|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373505|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373506|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373507|NCT01059799|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373508|NCT01059799|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
373509|NCT01059773|B3|Baseline|Total|Total of all reporting groups
373510|NCT01059773|B2|Baseline|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
373511|NCT01059773|B1|Baseline|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373512|NCT01059773|P2|Participant Flow|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
373513|NCT01059773|P1|Participant Flow|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373514|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
373515|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
373516|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
373517|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
373518|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
373519|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
373520|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
373521|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
373522|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
373523|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
373524|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373525|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373526|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
373527|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
373528|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373529|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373530|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
373531|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
373532|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
373533|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
373534|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373535|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373536|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
373537|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
373538|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373539|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373540|NCT01059773|E2|Reported Event|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
373541|NCT01059773|E1|Reported Event|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
373542|NCT01059760|B3|Baseline|Total|Total of all reporting groups
373543|NCT01059760|B2|Baseline|Fed Day First|28± 4 hours fed followed by 28± 4 hours of fasting
373544|NCT01059760|B1|Baseline|Fasting Day First|28±4 hours of water-only fasting followed by 28±4 hours fed
373545|NCT01059760|P2|Participant Flow|Fed Day First|28± 4 hours fed followed by 28± 4 hours of fasting
373546|NCT01059760|P1|Participant Flow|Fasting Day First|28±4 hours of water-only fasting followed by 28±4 hours fed
373547|NCT01059760|O3|Outcome|Change When Fed|
373548|NCT01059760|O2|Outcome|Change While Fasting|
373549|NCT01059760|O1|Outcome|Baseline Value|
373550|NCT01059760|O3|Outcome|Change When Fed|
373551|NCT01059760|O2|Outcome|Change While Fasting|
373552|NCT01059760|O1|Outcome|Baseline Value|
373553|NCT01059760|O3|Outcome|Change When Fed|
373554|NCT01059760|O2|Outcome|Change While Fasting|
373555|NCT01059760|O1|Outcome|Baseline Value|
373556|NCT01059760|O3|Outcome|Change When Fed|
373557|NCT01059760|O2|Outcome|Change While Fasting|
373558|NCT01059760|O1|Outcome|Baseline Value|
373559|NCT01059760|O3|Outcome|Change When Fed|
373560|NCT01059760|O2|Outcome|Change While Fasting|
373561|NCT01059760|O1|Outcome|Baseline Value|
373562|NCT01059760|O3|Outcome|Change When Fed|
373563|NCT01059760|O2|Outcome|Change While Fasting|
373564|NCT01059760|O1|Outcome|Baseline Value|
373565|NCT01059760|O3|Outcome|Change When Fed|
373566|NCT01059760|O2|Outcome|Change While Fasting|
373567|NCT01059760|O1|Outcome|Baseline Value|
373568|NCT01059760|O3|Outcome|Change When Fed|
373569|NCT01059760|O2|Outcome|Change While Fasting|
373570|NCT01059760|O1|Outcome|Baseline Value|
373571|NCT01059760|O3|Outcome|Change When Fed|
373572|NCT01059760|O2|Outcome|Change While Fasting|
373573|NCT01059760|O1|Outcome|Baseline Value|
373574|NCT01059760|O3|Outcome|Change When Fed|
373575|NCT01059760|O2|Outcome|Change While Fasting|
373576|NCT01059760|O1|Outcome|Baseline Value|
373577|NCT01059760|O3|Outcome|Change When Fed|
373578|NCT01059760|O2|Outcome|Change While Fasting|
373579|NCT01059760|O1|Outcome|Baseline Value|
373580|NCT01059760|O3|Outcome|Change When Fed|
373581|NCT01059760|O2|Outcome|Change While Fasting|
373582|NCT01059760|O1|Outcome|Baseline Value|
373583|NCT01059760|O3|Outcome|Change When Fed|
373584|NCT01059760|O2|Outcome|Change While Fasting|
373585|NCT01059760|O1|Outcome|Baseline Value|
373586|NCT01059760|O3|Outcome|Change When Fed|
373587|NCT01059760|O2|Outcome|Change While Fasting|
373588|NCT01059760|O1|Outcome|Baseline Value|
373589|NCT01059760|O3|Outcome|Change When Fed|
373631|NCT01059760|O3|Outcome|Change When Fed|
373632|NCT01059760|O2|Outcome|Change While Fasting|
373633|NCT01059760|O1|Outcome|Baseline Value|
373634|NCT01059760|O3|Outcome|Change When Fed|
373635|NCT01059760|O2|Outcome|Change While Fasting|
373636|NCT01059760|O1|Outcome|Baseline Value|
373637|NCT01059760|O3|Outcome|Change When Fed|
373638|NCT01059760|O2|Outcome|Change While Fasting|
373639|NCT01059760|O1|Outcome|Baseline Value|
373640|NCT01059760|O3|Outcome|Change When Fed|
373641|NCT01059760|O2|Outcome|Change While Fasting|
373642|NCT01059760|O1|Outcome|Baseline Value|
373643|NCT01059760|O3|Outcome|Change When Fed|
373644|NCT01059760|O2|Outcome|Change While Fasting|
373645|NCT01059760|O1|Outcome|Baseline Value|
373646|NCT01059760|O3|Outcome|Change When Fed|
373647|NCT01059760|O2|Outcome|Change While Fasting|
373648|NCT01059760|O1|Outcome|Baseline Value|
373649|NCT01059760|E2|Reported Event|Fed Day First|Includes those who fasted on the 2nd day.
373650|NCT01059760|E1|Reported Event|Fasting Day First|Includes those who fasted on the 1st day.
373651|NCT01059643|B1|Baseline|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373652|NCT01059643|P1|Participant Flow|LY2523355|"LY2523355: Dose determined by participant's body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21-day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373653|NCT01059643|O1|Outcome|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373654|NCT01059643|O2|Outcome|6 mg/m² LY253355|LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
373655|NCT01059643|O1|Outcome|5 mg/m²LY2523355|LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
373656|NCT01059643|O2|Outcome|6 mg/m² LY253355|LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
373657|NCT01059643|O1|Outcome|5 mg/m² LY2523355|LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
373658|NCT01059643|O1|Outcome|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373659|NCT01059643|O1|Outcome|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373660|NCT01059643|O1|Outcome|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373661|NCT01059643|O1|Outcome|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373737|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
374081|NCT01058642|B5|Baseline|Total|Total of all reporting groups
373662|NCT01059643|O1|Outcome|LY2523355|"LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373663|NCT01059643|E1|Reported Event|LY2523355|"LY2523355: Dose determined by participant's body surface area: 5 milligrams/meter squared (mg/m²) or 6 mg/m², administered intravenously on days 1, 2, 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.~Pegfilgrastim: 6 milligrams (mg), administered subcutaneously 24 hours after third dose of LY2523355 on day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment."
373664|NCT01059630|B3|Baseline|Total|Total of all reporting groups
373665|NCT01059630|B2|Baseline|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373666|NCT01059630|B1|Baseline|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373667|NCT01059630|P2|Participant Flow|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with complete response (CR), partial response (PR) or stable disease (SD) then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373668|NCT01059630|P1|Participant Flow|Bendamustine Alone|Participants received Bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373669|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373670|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373671|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373672|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373673|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373674|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373675|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373676|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373677|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373678|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373738|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373742|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
373679|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373680|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373681|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373682|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373683|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373684|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373685|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373686|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373687|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373688|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373689|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373690|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373691|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373692|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373693|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373694|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373695|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373696|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
374015|NCT01058941|B3|Baseline|Total|Total of all reporting groups
373697|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373698|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373699|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373700|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373701|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373702|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373703|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373704|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373705|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373706|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373707|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373708|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373709|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373710|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373711|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373712|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373713|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373714|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373739|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373740|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
374736|NCT01056198|O1|Outcome|Santyl|2 mm Santyl QD
373715|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373716|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373717|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373718|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373719|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373720|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373721|NCT01059630|E2|Reported Event|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
373722|NCT01059630|E1|Reported Event|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
373723|NCT01059617|B5|Baseline|Total|Total of all reporting groups
373724|NCT01059617|B4|Baseline|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373725|NCT01059617|B3|Baseline|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373726|NCT01059617|B2|Baseline|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373727|NCT01059617|B1|Baseline|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373728|NCT01059617|P4|Participant Flow|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373729|NCT01059617|P3|Participant Flow|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373730|NCT01059617|P2|Participant Flow|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373731|NCT01059617|P1|Participant Flow|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373732|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373733|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373734|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373735|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373736|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373741|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373743|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373744|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373745|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373746|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373747|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373748|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373749|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373750|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373751|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373752|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
373753|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373754|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
373755|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373756|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373757|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373758|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373759|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373760|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373761|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373762|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373763|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373764|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373765|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373766|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373767|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373768|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
374176|NCT01058005|B1|Baseline|Natalizumab|300 mg intravenous injection every 4 weeks
373769|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373770|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373771|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373772|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373773|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373774|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373775|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373776|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373777|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373778|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373779|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373780|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
373781|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373782|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
373783|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373784|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373785|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373786|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373787|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373788|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373789|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373790|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373791|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373792|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373793|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373794|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373795|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373796|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373797|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373798|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373799|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373800|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373801|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373802|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373803|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373804|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
373805|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373806|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373807|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373808|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373809|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373810|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373811|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373812|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373813|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373814|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373815|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day143.
373816|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373817|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm a t Days 0 and 122 and of the dominant arm at Day143.
373818|NCT01059617|O2|Outcome|Placebo Group|Subjects received a saline placebo on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373819|NCT01059617|O1|Outcome|Flulaval Group|Subjects received Flulaval vaccine on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373820|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373821|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373822|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373823|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373824|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373825|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373826|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373827|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373828|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373829|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373830|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373831|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373832|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373833|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373834|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373835|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373836|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373837|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373838|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373839|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373840|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373841|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373842|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373843|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373844|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373845|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373846|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373847|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373848|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373849|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373850|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373851|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373852|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373853|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373854|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373855|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373856|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373857|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373858|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373859|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373860|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373861|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373862|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373863|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373864|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373865|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373866|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373867|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373868|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373869|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373870|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373871|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373872|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373873|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373874|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373875|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373876|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373877|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373878|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373879|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373880|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373881|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373882|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373883|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373884|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373885|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373886|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373887|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373888|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373889|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373890|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373891|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373892|NCT01059617|E6|Reported Event|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
373893|NCT01059617|E5|Reported Event|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
373894|NCT01059617|E4|Reported Event|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373895|NCT01059617|E3|Reported Event|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373896|NCT01059617|E2|Reported Event|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373897|NCT01059617|E1|Reported Event|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
373898|NCT01059565|B3|Baseline|Total|Total of all reporting groups
373899|NCT01059565|B2|Baseline|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373900|NCT01059565|B1|Baseline|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373901|NCT01059565|P2|Participant Flow|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase.
373902|NCT01059565|P1|Participant Flow|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase.
373903|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373904|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373905|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373906|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373907|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373908|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373909|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373910|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373911|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373912|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373913|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373914|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373915|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373916|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373917|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373918|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373919|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373920|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373921|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373922|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373923|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373924|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373925|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373926|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373927|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373928|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373929|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373930|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
373931|NCT01059565|E4|Reported Event|Placebo/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
373932|NCT01059565|E3|Reported Event|AZLI/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
373933|NCT01059565|E2|Reported Event|Placebo|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24.
373934|NCT01059565|E1|Reported Event|AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24.
373935|NCT01059526|B3|Baseline|Total|Total of all reporting groups
373936|NCT01059526|B2|Baseline|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
373937|NCT01059526|B1|Baseline|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
373938|NCT01059526|P2|Participant Flow|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
373939|NCT01059526|P1|Participant Flow|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
373940|NCT01059526|O2|Outcome|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
373941|NCT01059526|O1|Outcome|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
373942|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
373943|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
373944|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
373945|NCT01059526|E1|Reported Event|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
373946|NCT01059344|B3|Baseline|Total|Total of all reporting groups
373947|NCT01059344|B2|Baseline|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
373948|NCT01059344|B1|Baseline|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
373949|NCT01059344|P2|Participant Flow|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
373950|NCT01059344|P1|Participant Flow|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
373951|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
373952|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
373953|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
373954|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
373955|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
373956|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
373957|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
373958|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
373959|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
373960|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
373961|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
373962|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
373963|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
373964|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
373965|NCT01059344|E2|Reported Event|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
373966|NCT01059344|E1|Reported Event|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
373967|NCT01059305|B1|Baseline|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
373968|NCT01059305|P1|Participant Flow|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
373969|NCT01059305|O1|Outcome|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
373970|NCT01059305|E1|Reported Event|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
373971|NCT01059175|B3|Baseline|Total|Total of all reporting groups
373972|NCT01059175|B2|Baseline|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373973|NCT01059175|B1|Baseline|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373974|NCT01059175|P2|Participant Flow|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373975|NCT01059175|P1|Participant Flow|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373976|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373977|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373978|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373979|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373980|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373981|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373982|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373983|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
374049|NCT01058668|P2|Participant Flow|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
373984|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373985|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373986|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373987|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373988|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373989|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373990|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373991|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373992|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373993|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373994|NCT01059175|E2|Reported Event|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373995|NCT01059175|E1|Reported Event|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
373996|NCT01059071|B1|Baseline|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
373997|NCT01059071|P4|Participant Flow|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
373998|NCT01059071|P3|Participant Flow|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
373999|NCT01059071|P2|Participant Flow|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374000|NCT01059071|P1|Participant Flow|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374001|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374050|NCT01058668|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374002|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374003|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374004|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374005|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374006|NCT01059071|O4|Outcome|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374007|NCT01059071|O3|Outcome|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374008|NCT01059071|O2|Outcome|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374009|NCT01059071|O1|Outcome|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374010|NCT01059071|E1|Reported Event|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
374011|NCT01058993|B1|Baseline|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
374012|NCT01058993|P1|Participant Flow|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
374013|NCT01058993|O1|Outcome|SINGLE Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
374014|NCT01058993|E1|Reported Event|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
374016|NCT01058941|B2|Baseline|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374017|NCT01058941|B1|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374018|NCT01058941|P2|Participant Flow|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374019|NCT01058941|P1|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374020|NCT01058941|O2|Outcome|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374021|NCT01058941|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374022|NCT01058941|O2|Outcome|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374023|NCT01058941|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374024|NCT01058941|E2|Reported Event|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374025|NCT01058941|E1|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
374026|NCT01058863|B1|Baseline|Randomized Treated Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
374027|NCT01058863|P1|Participant Flow|All Randomized Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
374028|NCT01058863|O1|Outcome|All Randomized Participants|Participants were randomized to one of five treatment arms, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
374029|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
374030|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
374031|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
374032|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
374033|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
374034|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
374035|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
374036|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
374037|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
374038|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
374039|NCT01058863|E5|Reported Event|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
374040|NCT01058863|E4|Reported Event|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
374041|NCT01058863|E3|Reported Event|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
374042|NCT01058863|E2|Reported Event|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
374043|NCT01058863|E1|Reported Event|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
374044|NCT01058668|B4|Baseline|Total|Total of all reporting groups
374045|NCT01058668|B3|Baseline|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
374046|NCT01058668|B2|Baseline|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
374047|NCT01058668|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374048|NCT01058668|P3|Participant Flow|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
374051|NCT01058668|O3|Outcome|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
374052|NCT01058668|O2|Outcome|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
374053|NCT01058668|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374054|NCT01058668|O3|Outcome|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
374055|NCT01058668|O2|Outcome|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
374056|NCT01058668|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374057|NCT01058668|E3|Reported Event|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
374058|NCT01058668|E2|Reported Event|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
374059|NCT01058668|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374060|NCT01058655|B5|Baseline|Total|Total of all reporting groups
374061|NCT01058655|B4|Baseline|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374062|NCT01058655|B3|Baseline|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374063|NCT01058655|B2|Baseline|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374064|NCT01058655|B1|Baseline|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374065|NCT01058655|P4|Participant Flow|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374066|NCT01058655|P3|Participant Flow|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374067|NCT01058655|P2|Participant Flow|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374068|NCT01058655|P1|Participant Flow|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374069|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374070|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374071|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374072|NCT01058655|O3|Outcome|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374073|NCT01058655|O2|Outcome|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374074|NCT01058655|O1|Outcome|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374075|NCT01058655|O1|Outcome|Phase I: Evaluable|All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
374076|NCT01058655|O1|Outcome|Phase I: Evaluable|All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
374077|NCT01058655|E4|Reported Event|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374078|NCT01058655|E3|Reported Event|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374079|NCT01058655|E2|Reported Event|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374080|NCT01058655|E1|Reported Event|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
374082|NCT01058642|B4|Baseline|Treatment Sequence 4: ADL5747 Then Placebo|"ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods.~Placebo: Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
374083|NCT01058642|B3|Baseline|Treatment Sequence 3: Placebo Then ADL5747|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods."
374084|NCT01058642|B2|Baseline|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.~Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
374085|NCT01058642|B1|Baseline|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period."
374086|NCT01058642|P4|Participant Flow|Treatment Sequence 4: ADL5747 Then Placebo|"During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
374087|NCT01058642|P3|Participant Flow|Treatment Sequence 3: Placebo Then ADL5747|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week"
374088|NCT01058642|P2|Participant Flow|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).~At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
374089|NCT01058642|P1|Participant Flow|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days."
374090|NCT01058642|O3|Outcome|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
374091|NCT01058642|O2|Outcome|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
374092|NCT01058642|O1|Outcome|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
374093|NCT01058642|E3|Reported Event|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
374094|NCT01058642|E2|Reported Event|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
374095|NCT01058642|E1|Reported Event|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
374096|NCT01058421|B3|Baseline|Total|Total of all reporting groups
374097|NCT01058421|B2|Baseline|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374098|NCT01058421|B1|Baseline|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374169|NCT01058070|P1|Participant Flow|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
374099|NCT01058421|P2|Participant Flow|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374100|NCT01058421|P1|Participant Flow|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374101|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374102|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374103|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374104|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374105|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374106|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374107|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374108|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374109|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374110|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374111|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374112|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374113|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374114|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374115|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374116|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374117|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374118|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374119|NCT01058421|E2|Reported Event|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
374120|NCT01058421|E1|Reported Event|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
374121|NCT01058356|B1|Baseline|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
374122|NCT01058356|P1|Participant Flow|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
374123|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
374124|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
374125|NCT01058356|E1|Reported Event|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
374126|NCT01058304|B3|Baseline|Total|Total of all reporting groups
374170|NCT01058070|O1|Outcome|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
374171|NCT01058070|O1|Outcome|LINX Study Subjects|Subjects implanted with LINX device
374172|NCT01058070|E1|Reported Event|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
374173|NCT01058005|B4|Baseline|Total|Total of all reporting groups
374127|NCT01058304|B2|Baseline|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
374128|NCT01058304|B1|Baseline|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
374129|NCT01058304|P2|Participant Flow|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
374130|NCT01058304|P1|Participant Flow|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
374131|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
374132|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
374133|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
374134|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
374135|NCT01058304|E2|Reported Event|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
374136|NCT01058304|E1|Reported Event|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
374137|NCT01058265|B3|Baseline|Total|Total of all reporting groups
374138|NCT01058265|B2|Baseline|Standard|Standard general medical evaluation.
374139|NCT01058265|B1|Baseline|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
374140|NCT01058265|P2|Participant Flow|Standard|Standard general medical evaluation.
374174|NCT01058005|B3|Baseline|Glatiramer Acetate|20 mg subcutaneous injection once daily
374175|NCT01058005|B2|Baseline|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
374141|NCT01058265|P1|Participant Flow|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
374142|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
374143|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
374144|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
374145|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
374146|NCT01058265|E2|Reported Event|Standard|Standard general medical evaluation.
374147|NCT01058265|E1|Reported Event|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
374148|NCT01058239|B1|Baseline|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374149|NCT01058239|P1|Participant Flow|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374150|NCT01058239|O1|Outcome|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374151|NCT01058239|O1|Outcome|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374152|NCT01058239|O1|Outcome|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374153|NCT01058239|O1|Outcome|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374154|NCT01058239|O1|Outcome|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374155|NCT01058239|O1|Outcome|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374156|NCT01058239|E1|Reported Event|Rituximab Plus Bortezomib|"This is a single arm trial adding the new drug bortezomib to the standard drug rituximab~bortezomib: Given intravenously on days 1, 4, 8 and 11 of every cycle~rituximab: given intravenously on days 1, 8 and 15 of Cycle 1 and on Day 1 of subsequent cycles"
374157|NCT01058096|B3|Baseline|Total|Total of all reporting groups
374158|NCT01058096|B2|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
374159|NCT01058096|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374160|NCT01058096|P2|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
374161|NCT01058096|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374162|NCT01058096|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
374163|NCT01058096|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374164|NCT01058096|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
374165|NCT01058096|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374166|NCT01058096|E2|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
374167|NCT01058096|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
374168|NCT01058070|B1|Baseline|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
374177|NCT01058005|P3|Participant Flow|Glatiramer Acetate|20 mg subcutaneous injection once daily
374178|NCT01058005|P2|Participant Flow|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
374179|NCT01058005|P1|Participant Flow|Natalizumab|300 mg intravenous injection every 4 weeks
374180|NCT01058005|O3|Outcome|Glatiramer Acetate|20 mg subcutaneous injection once daily
374181|NCT01058005|O2|Outcome|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
374182|NCT01058005|O1|Outcome|Natalizumab|300 mg intravenous injection every 4 weeks
374183|NCT01058005|E3|Reported Event|Glatiramer Acetate|20 mg subcutaneous injection once daily
374184|NCT01058005|E2|Reported Event|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
374185|NCT01058005|E1|Reported Event|Natalizumab|300 mg intravenous injection every 4 weeks
374186|NCT01057901|B3|Baseline|Total|Total of all reporting groups
374187|NCT01057901|B2|Baseline|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
374188|NCT01057901|B1|Baseline|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
374189|NCT01057901|P2|Participant Flow|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
374190|NCT01057901|P1|Participant Flow|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
374191|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
374192|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
374193|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
374194|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
374195|NCT01057901|E2|Reported Event|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
374196|NCT01057901|E1|Reported Event|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
374197|NCT01057888|B4|Baseline|Total|Total of all reporting groups
374198|NCT01057888|B3|Baseline|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
374199|NCT01057888|B2|Baseline|Controls|"Controls~Received standard of care provided by practice"
374200|NCT01057888|B1|Baseline|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
374201|NCT01057888|P3|Participant Flow|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
374202|NCT01057888|P2|Participant Flow|Controls|"Controls~Received standard of care provided by practice"
374203|NCT01057888|P1|Participant Flow|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
374204|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
374205|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
374206|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
374207|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
374208|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
374209|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
374210|NCT01057888|E1|Reported Event|Mailed Reminders and Letter Reminders|
374211|NCT01057862|B3|Baseline|Total|Total of all reporting groups
374212|NCT01057862|B2|Baseline|Placebo|Placebo
374213|NCT01057862|B1|Baseline|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
374214|NCT01057862|P2|Participant Flow|Placebo|
374215|NCT01057862|P1|Participant Flow|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
374216|NCT01057862|O2|Outcome|Placebo|Placebo
374217|NCT01057862|O1|Outcome|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
374218|NCT01057862|O2|Outcome|Placebo|Placebo
374219|NCT01057862|O1|Outcome|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
374220|NCT01057862|E2|Reported Event|Placebo|Placebo
374221|NCT01057862|E1|Reported Event|Naltrexone|Naltrexone: Targeted dosage of 50mg PO daily
374222|NCT01057810|B3|Baseline|Total|Total of all reporting groups
374223|NCT01057810|B2|Baseline|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374224|NCT01057810|B1|Baseline|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374225|NCT01057810|P2|Participant Flow|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374310|NCT01057277|E1|Reported Event|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
374226|NCT01057810|P1|Participant Flow|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374227|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374228|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374229|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374230|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374231|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374232|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374233|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374234|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374235|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374236|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374237|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374238|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374239|NCT01057810|E2|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374240|NCT01057810|E1|Reported Event|PLACEBO|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
374241|NCT01057693|B1|Baseline|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374242|NCT01057693|P3|Participant Flow|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374243|NCT01057693|P2|Participant Flow|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374244|NCT01057693|P1|Participant Flow|Pregabalin SB|Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.
374311|NCT01057251|B3|Baseline|Total|Total of all reporting groups
374245|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374246|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374247|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374248|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374249|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374250|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374251|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374252|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374253|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374254|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374255|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374256|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374257|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374258|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374259|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374260|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374261|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374262|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374263|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374264|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374265|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374266|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374267|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374268|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374269|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
375408|NCT01054573|B5|Baseline|Total|Total of all reporting groups
374270|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374271|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374272|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374273|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374274|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374275|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374276|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374277|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374278|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374279|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374280|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374281|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374282|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374283|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374284|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374285|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374286|NCT01057693|E3|Reported Event|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
374287|NCT01057693|E2|Reported Event|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
374288|NCT01057693|E1|Reported Event|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
374289|NCT01057589|B1|Baseline|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374290|NCT01057589|P1|Participant Flow|Pemetrexed + Cisplatin + Cetuximab|"Pemetrexed 500 milligram per meter squared (mg/m^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles.~At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.~Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements."
374312|NCT01057251|B2|Baseline|Placebo|Dose-matched placebo, once daily oral administration
374291|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374292|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374293|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374294|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374295|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374296|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374297|NCT01057589|E1|Reported Event|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
374298|NCT01057433|B1|Baseline|All Subjects|
374299|NCT01057433|P1|Participant Flow|All Subjects|
374300|NCT01057433|O1|Outcome|All Subjects|
374301|NCT01057433|E1|Reported Event|All Subjects|
374302|NCT01057394|B1|Baseline|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
374303|NCT01057394|P2|Participant Flow|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
374304|NCT01057394|P1|Participant Flow|Radiofrequency Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
374305|NCT01057394|O1|Outcome|Number of Chronically Isolated Pulmonary Veins|
374306|NCT01057394|E1|Reported Event|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
374307|NCT01057277|B1|Baseline|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
374308|NCT01057277|P1|Participant Flow|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
374309|NCT01057277|O1|Outcome|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
374313|NCT01057251|B1|Baseline|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
374314|NCT01057251|P2|Participant Flow|Placebo|Dose-matched placebo, once daily oral administration
374315|NCT01057251|P1|Participant Flow|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
374316|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
374317|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
374318|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
374319|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
374320|NCT01057251|E2|Reported Event|Placebo|Dose-matched placebo, once daily oral administration
374321|NCT01057251|E1|Reported Event|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
374322|NCT01057225|B1|Baseline|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374323|NCT01057225|P6|Participant Flow|Phase II: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374324|NCT01057225|P5|Participant Flow|Phase II: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374325|NCT01057225|P4|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374326|NCT01057225|P3|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374327|NCT01057225|P2|Participant Flow|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374328|NCT01057225|P1|Participant Flow|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374329|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374330|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374331|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374332|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374333|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374334|NCT01057225|O4|Outcome|Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374335|NCT01057225|O3|Outcome|Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374336|NCT01057225|O2|Outcome|Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374337|NCT01057225|O1|Outcome|Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374338|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374339|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374340|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374341|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374475|NCT01056653|B1|Baseline|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
374476|NCT01056653|P3|Participant Flow|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only (at 4 months of age)"
374342|NCT01057225|O4|Outcome|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374343|NCT01057225|O3|Outcome|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374344|NCT01057225|O2|Outcome|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374345|NCT01057225|O1|Outcome|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
374346|NCT01057225|E1|Reported Event|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
374347|NCT01057121|B3|Baseline|Total|Total of all reporting groups
374348|NCT01057121|B2|Baseline|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374349|NCT01057121|B1|Baseline|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374350|NCT01057121|P5|Participant Flow|Phase II: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
374351|NCT01057121|P4|Participant Flow|Phase I: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
374352|NCT01057121|P3|Participant Flow|Phase I, Treatment Ienalidomide), 20 mg/Day|Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
374353|NCT01057121|P2|Participant Flow|Phase I: Treatment (Lenalidomide), 15 mg/Day|Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
374354|NCT01057121|P1|Participant Flow|Phase I: Treatment (Lenalidomide) , 10 mg/Day|Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
374355|NCT01057121|O2|Outcome|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374356|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374357|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374358|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374359|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374360|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374361|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374362|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374363|NCT01057121|O4|Outcome|Phase I: Treatment (Lenalidomide), 25 mg/Day|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374364|NCT01057121|O3|Outcome|Phase I - 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374365|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374366|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day of lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374367|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374368|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374369|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374370|NCT01057121|O2|Outcome|Phase I - 15 mg/Day Lenalidomide|"Patients received lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374371|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Lenalidomide|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374372|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374373|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374374|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374375|NCT01057121|O2|Outcome|Phase I - 15 mg/Day (Lenalidomide)|"Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374376|NCT01057121|O1|Outcome|Phase I - 10 mg/Day (Lenalidomide)|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374377|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)"
374378|NCT01057121|E4|Reported Event|Phase I and II: 25 mg/Day Lenalidomide|"Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374379|NCT01057121|E3|Reported Event|Phase I: 20 mg/Day Lenalidomide|"Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374380|NCT01057121|E2|Reported Event|Phase I: 15 mg/Day Lenalidomide|"Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374381|NCT01057121|E1|Reported Event|Phase I: 10 mg/Day Lenalidomide|"Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
374382|NCT01057017|B1|Baseline|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
374477|NCT01056653|P2|Participant Flow|Group B Purple|"Four home visits~High Dose: Four home visits (at 4, 5, 6, and 7 months of age)"
374383|NCT01057017|P1|Participant Flow|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
374384|NCT01057017|O1|Outcome|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
374385|NCT01057017|E1|Reported Event|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
374386|NCT01056913|B1|Baseline|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
374387|NCT01056913|P1|Participant Flow|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
374388|NCT01056913|O1|Outcome|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
374389|NCT01056913|E1|Reported Event|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
374390|NCT01056822|B3|Baseline|Total|Total of all reporting groups
374391|NCT01056822|B2|Baseline|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374392|NCT01056822|B1|Baseline|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374393|NCT01056822|P2|Participant Flow|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374394|NCT01056822|P1|Participant Flow|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374395|NCT01056822|O1|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374396|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374397|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374398|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374399|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374400|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374447|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374401|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374402|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374403|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374404|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374405|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374406|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374407|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374408|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374409|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374410|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374411|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374412|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374413|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374414|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374448|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374415|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374416|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374417|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374418|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374419|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374420|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374421|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374422|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374423|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374424|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374425|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374426|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374427|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374428|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374449|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374429|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374430|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374431|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374432|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374433|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374434|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374435|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374436|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374437|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374438|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
374439|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
374440|NCT01056822|E2|Reported Event|Micofenolato Mofetilo|Micofenolato mofetilo
374441|NCT01056822|E1|Reported Event|Micofenolato Sodium|Micofenolato sodium
374442|NCT01056718|B1|Baseline|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374443|NCT01056718|P1|Participant Flow|Nebivolol Treatment|10 week open label nebivolol treatment.
374444|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374445|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374446|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374473|NCT01056653|B3|Baseline|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
374474|NCT01056653|B2|Baseline|Group B Purple|"Four home visits~High Dose: Four home visits"
374450|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374451|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374452|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374453|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374454|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374455|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374456|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374457|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374458|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374459|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374460|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374461|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374462|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374463|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374464|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374465|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374466|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374467|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374468|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374469|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374470|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374471|NCT01056718|E1|Reported Event|Starting on 5 mg of Nebivolol Then Titrated|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
374472|NCT01056653|B4|Baseline|Total|Total of all reporting groups
374478|NCT01056653|P1|Participant Flow|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits (at 4 and 6 months of age)"
374479|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
374480|NCT01056653|O2|Outcome|Group B Purple|"Four home visits~High Dose: Four home visits"
374481|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
374482|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
374483|NCT01056653|O2|Outcome|Group B Purple|"Four intervention home visits~High Dose: Four home visits"
374484|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
374485|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
374486|NCT01056653|O2|Outcome|Group B Purple|"Four intervention home visits~High Dose: Four home visits"
374487|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
374488|NCT01056653|E3|Reported Event|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
374489|NCT01056653|E2|Reported Event|Group B Purple|"Four home visits~High Dose: Four home visits"
374490|NCT01056653|E1|Reported Event|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
374491|NCT01056640|B3|Baseline|Total|Total of all reporting groups
374492|NCT01056640|B2|Baseline|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
374493|NCT01056640|B1|Baseline|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
374494|NCT01056640|P2|Participant Flow|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
374495|NCT01056640|P1|Participant Flow|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
374496|NCT01056640|O2|Outcome|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
374497|NCT01056640|O1|Outcome|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
374498|NCT01056640|E2|Reported Event|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
374499|NCT01056640|E1|Reported Event|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
374616|NCT01056341|P4|Participant Flow|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
374617|NCT01056341|P3|Participant Flow|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
374500|NCT01056601|B1|Baseline|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
374501|NCT01056601|P1|Participant Flow|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
374502|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
374503|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
374504|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
374505|NCT01056601|E1|Reported Event|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
374506|NCT01056523|B1|Baseline|Ribavirin and Cytarabine|Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID Drug: Cytarabine arabinoside Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.
374507|NCT01056523|P7|Participant Flow|Dose Level 7|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
374508|NCT01056523|P6|Participant Flow|Dose Level 6|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
374509|NCT01056523|P5|Participant Flow|Dose Level 5|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
374510|NCT01056523|P4|Participant Flow|Dose Level 4|Ribavirin 2200 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
374511|NCT01056523|P3|Participant Flow|Dose Level 3|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
374512|NCT01056523|P2|Participant Flow|Dose Level 2|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
374513|NCT01056523|P1|Participant Flow|Dose Level 1|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
374514|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
374515|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
374516|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
374517|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
374518|NCT01056523|O1|Outcome|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
374519|NCT01056523|E1|Reported Event|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
374520|NCT01056510|B3|Baseline|Total|Total of all reporting groups
374521|NCT01056510|B2|Baseline|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374522|NCT01056510|B1|Baseline|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374523|NCT01056510|P2|Participant Flow|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally (PO) at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until complete response (CR) was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374618|NCT01056341|P2|Participant Flow|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
374619|NCT01056341|P1|Participant Flow|Placebo|Placebo: Treatment with placebo for 6 months
375573|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
374524|NCT01056510|P1|Participant Flow|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received intravenous (IV) rituximab 375 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced progressive disease (PD).
374525|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374526|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374527|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374528|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374529|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374530|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374531|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374532|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374533|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374534|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374535|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374536|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374537|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374620|NCT01056341|O2|Outcome|Propranolol 3mg/kg/d 6 Months|Propranolol 3 mg/kg/day for 6 months
374621|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
374622|NCT01056341|O5|Outcome|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
374735|NCT01056198|O1|Outcome|Control|Daily gauze and optional sharp debridement
374538|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374539|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374540|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374541|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374542|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374543|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374544|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374545|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374546|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374547|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374548|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374549|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374550|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374551|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374623|NCT01056341|O4|Outcome|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
374624|NCT01056341|O3|Outcome|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
374625|NCT01056341|O2|Outcome|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
374626|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
374552|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374553|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374554|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374555|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374556|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374557|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374558|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374559|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374560|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374561|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374562|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374563|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374564|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374565|NCT01056510|E2|Reported Event|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374627|NCT01056341|E10|Reported Event|W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
374628|NCT01056341|E9|Reported Event|W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
374629|NCT01056341|E8|Reported Event|W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
374566|NCT01056510|E1|Reported Event|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
374567|NCT01056484|B3|Baseline|Total|Total of all reporting groups
374568|NCT01056484|B2|Baseline|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
374569|NCT01056484|B1|Baseline|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
374570|NCT01056484|P2|Participant Flow|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
374571|NCT01056484|P1|Participant Flow|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
374572|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
374573|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
374574|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
374575|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
374576|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
374577|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
374578|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
374630|NCT01056341|E7|Reported Event|W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
374631|NCT01056341|E6|Reported Event|W72-follow-up Period of ex Placebo Group-safety Set|72-week follow-up period without study treatment administration
374632|NCT01056341|E5|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 6 months
374579|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
374580|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
374581|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
374582|NCT01056484|E2|Reported Event|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
374583|NCT01056484|E1|Reported Event|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
374584|NCT01056380|B3|Baseline|Total|Total of all reporting groups
374585|NCT01056380|B2|Baseline|Placebo|Placebo : Tablet, twice daily with food for 5 days
374586|NCT01056380|B1|Baseline|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
374587|NCT01056380|P2|Participant Flow|Placebo|Placebo : Tablet, twice daily with food for 5 days
374588|NCT01056380|P1|Participant Flow|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
374589|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374590|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374591|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374592|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374593|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374594|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374595|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374596|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374597|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374598|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374599|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374600|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374601|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374602|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374603|NCT01056380|O2|Outcome|Placebo|Placebo: Tablet, twice daily with food for 5 days
374604|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide: Tablet, 500 mg with food twice daily for 5 days
374605|NCT01056380|O2|Outcome|Placebo|Placebo : Tablet, twice daily with food for 5 days
374606|NCT01056380|O1|Outcome|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
374607|NCT01056380|E2|Reported Event|Placebo|Placebo : Tablet, twice daily with food for 5 days
374608|NCT01056380|E1|Reported Event|Nitazoxanide|Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
374609|NCT01056341|B6|Baseline|Total|Total of all reporting groups
374610|NCT01056341|B5|Baseline|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
374611|NCT01056341|B4|Baseline|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
374612|NCT01056341|B3|Baseline|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
374613|NCT01056341|B2|Baseline|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
374614|NCT01056341|B1|Baseline|Placebo|Placebo: Treatment with placebo for 6 months
374615|NCT01056341|P5|Participant Flow|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
374633|NCT01056341|E4|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 3 months, then placebo for 3 months
374634|NCT01056341|E3|Reported Event|W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 6 months
374635|NCT01056341|E2|Reported Event|W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 3 months, then placebo for 3 months
374636|NCT01056341|E1|Reported Event|W24-treatment Period-safety Set-Placebo|Placebo: Treatment with placebo for 6 months
374637|NCT01056328|B3|Baseline|Total|Total of all reporting groups
374638|NCT01056328|B2|Baseline|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
374639|NCT01056328|B1|Baseline|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374640|NCT01056328|P2|Participant Flow|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
374641|NCT01056328|P1|Participant Flow|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374642|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
374643|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374644|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
374645|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374646|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
374647|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374648|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated Radio Frequency (RF) Ablation System: Irrigated ablation catheter
374649|NCT01056328|O1|Outcome|St Jude Medical (SJM) Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374650|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
374651|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374652|NCT01056328|E2|Reported Event|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
374653|NCT01056328|E1|Reported Event|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
374654|NCT01056315|B3|Baseline|Total|Total of all reporting groups
374655|NCT01056315|B2|Baseline|Placebo|
374656|NCT01056315|B1|Baseline|GRT3983Y|
374657|NCT01056315|P2|Participant Flow|Placebo|
374658|NCT01056315|P1|Participant Flow|GRT3983Y|
374659|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374660|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374661|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374662|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374663|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374664|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374665|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374666|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374667|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374668|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374669|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374670|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374671|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374672|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374673|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374674|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374675|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374676|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374677|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374678|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374679|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374680|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374681|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374682|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374683|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374684|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374685|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374686|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374687|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
374688|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
374689|NCT01056315|E2|Reported Event|Placebo|
374690|NCT01056315|E1|Reported Event|GRT3983Y|
374691|NCT01056289|B1|Baseline|Entire Study Population|24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group).
374732|NCT01056198|B1|Baseline|Santyl|2 mm Santyl once daily (QD)
374733|NCT01056198|P2|Participant Flow|Control|Daily gauze and optional sharp debridement
374692|NCT01056289|P4|Participant Flow|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374693|NCT01056289|P3|Participant Flow|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374694|NCT01056289|P2|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
374695|NCT01056289|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks.
374696|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374697|NCT01056289|O2|Outcome|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374698|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
374699|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374700|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374701|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
374702|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374703|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374704|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
374705|NCT01056289|E4|Reported Event|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374706|NCT01056289|E3|Reported Event|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
374707|NCT01056289|E2|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
374708|NCT01056289|E1|Reported Event|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 24 Weeks.
374709|NCT01056276|B3|Baseline|Total|Total of all reporting groups
374710|NCT01056276|B2|Baseline|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374711|NCT01056276|B1|Baseline|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374712|NCT01056276|P2|Participant Flow|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374713|NCT01056276|P1|Participant Flow|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374714|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374715|NCT01056276|O1|Outcome|Originl BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374734|NCT01056198|P1|Participant Flow|Santyl|2 mm Santyl once daily (QD)
374716|NCT01056276|O2|Outcome|BBD Treatment|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374717|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374718|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374719|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374720|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374721|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374722|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374723|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374724|NCT01056276|E2|Reported Event|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
374725|NCT01056276|E1|Reported Event|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
374726|NCT01056263|B1|Baseline|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
374727|NCT01056263|P1|Participant Flow|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
374728|NCT01056263|O1|Outcome|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
374729|NCT01056263|E1|Reported Event|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
374730|NCT01056198|B3|Baseline|Total|Total of all reporting groups
374731|NCT01056198|B2|Baseline|Control|Daily gauze and optional sharp debridement
374737|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
374738|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
374739|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
374740|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
374741|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
374742|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
374743|NCT01056198|E2|Reported Event|Control|Daily gauze and optional sharp debridement
374744|NCT01056198|E1|Reported Event|Santyl|2 mm Santyl once daily (QD)
374745|NCT01056107|B5|Baseline|Total|Total of all reporting groups
374746|NCT01056107|B4|Baseline|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374747|NCT01056107|B3|Baseline|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374748|NCT01056107|B2|Baseline|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374749|NCT01056107|B1|Baseline|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374750|NCT01056107|P4|Participant Flow|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374751|NCT01056107|P3|Participant Flow|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374752|NCT01056107|P2|Participant Flow|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374753|NCT01056107|P1|Participant Flow|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374754|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374755|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374756|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374757|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374758|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374759|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374760|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374761|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374762|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374763|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374764|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374765|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374766|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374767|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374768|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374769|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374770|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374771|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374772|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374773|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374774|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374775|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374776|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
375574|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
374777|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374778|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374779|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374780|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374781|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374782|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374783|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374784|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374785|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374786|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374787|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374788|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374789|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374790|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374791|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374792|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374793|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374794|NCT01056107|E4|Reported Event|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374795|NCT01056107|E3|Reported Event|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374796|NCT01056107|E2|Reported Event|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374797|NCT01056107|E1|Reported Event|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
374798|NCT01056016|B3|Baseline|Total|Total of all reporting groups
374799|NCT01056016|B2|Baseline|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
374800|NCT01056016|B1|Baseline|Wait-list Control|Wait-list control group
374801|NCT01056016|P2|Participant Flow|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to American Academy of Pediatrics (AAP) ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics include the importance of obtaining parent and teacher behavioral ratings at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
374802|NCT01056016|P1|Participant Flow|Wait-list Control|Wait-list control group
374848|NCT01055769|P1|Participant Flow|Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
374849|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
375108|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
374803|NCT01056016|O2|Outcome|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
374804|NCT01056016|O1|Outcome|Wait-list Control|Wait-list control group
374805|NCT01056016|E2|Reported Event|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
374806|NCT01056016|E1|Reported Event|Wait-list Control|Wait-list control group
374807|NCT01055886|B3|Baseline|Total|Total of all reporting groups
374808|NCT01055886|B2|Baseline|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
374809|NCT01055886|B1|Baseline|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
374810|NCT01055886|P2|Participant Flow|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
374811|NCT01055886|P1|Participant Flow|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
374812|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
374813|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
374814|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
374815|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
374816|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
374817|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
374818|NCT01055886|E2|Reported Event|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
374819|NCT01055886|E1|Reported Event|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
374820|NCT01055834|B3|Baseline|Total|Total of all reporting groups
374821|NCT01055834|B2|Baseline|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone one 3 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B only proceeded to Period III where they received Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast for 3 days. At least a 5 day period passed before post treatment examinations."
374822|NCT01055834|B1|Baseline|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. At least a 5 day period passed before post treatment examinations.
374823|NCT01055834|P2|Participant Flow|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received a single dose of Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone one 3 mg tablet with water in the morning after fasting for 10 or more hours in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations."
374824|NCT01055834|P1|Participant Flow|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received a single dose of Eszopiclone one 3 mg tablet administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in Period II. At least a 5 day period passed before post treatment examinations.
374850|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374851|NCT01055769|O2|Outcome|Linezolid 600mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374852|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374825|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.~Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
374826|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.~Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
374827|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:~Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
374828|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:~Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
374829|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:~Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
374830|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:~Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
374831|NCT01055834|E4|Reported Event|Eszopiclone One 3 mg Tablet (Fasted)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fasted conditions.
374832|NCT01055834|E3|Reported Event|Eszopiclone One 3 mg Tablet (Fed)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fed conditions.
374833|NCT01055834|E2|Reported Event|Eszopiclone Three 1 mg Tablets|Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
374834|NCT01055834|E1|Reported Event|Eszopiclone One 3 mg Tablet|Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
374835|NCT01055782|B3|Baseline|Total|Total of all reporting groups
374836|NCT01055782|B2|Baseline|Without Endoguide|Colonoscopy completed without endoguide
374837|NCT01055782|B1|Baseline|With Endoguide|Colonoscopy completed with endoguide
374838|NCT01055782|P2|Participant Flow|Without Endoguide|Colonoscopy completed without endoguide
374839|NCT01055782|P1|Participant Flow|With Endoguide|Colonoscopy completed with endoguide
374840|NCT01055782|O2|Outcome|Without Endoguide|Colonoscopy completed without endoguide
374841|NCT01055782|O1|Outcome|With Endoguide|Colonoscopy completed with endoguide
374842|NCT01055782|O2|Outcome|Without Endoguide|Exams completed without endoguide. Success rate/completion.
374843|NCT01055782|O1|Outcome|With Endoguide - Success Rate|Exams completed with endoguide. Success rate/completion.
374844|NCT01055782|E2|Reported Event|Without Endoguide|Colonoscopy completed without endoguide
374845|NCT01055782|E1|Reported Event|With Endoguide|Colonoscopy completed with endoguide
374846|NCT01055769|B1|Baseline|Linezolid|Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374847|NCT01055769|P2|Participant Flow|Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
375109|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
374853|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374854|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374855|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374856|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374857|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374858|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374859|NCT01055769|E2|Reported Event|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374860|NCT01055769|E1|Reported Event|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
374861|NCT01055704|B5|Baseline|Total|Total of all reporting groups
374862|NCT01055704|B4|Baseline|Placebo|
374863|NCT01055704|B3|Baseline|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374864|NCT01055704|B2|Baseline|Codeine 30 mg|
374865|NCT01055704|B1|Baseline|Methylnaltrexone 0.30 mg/kg|
374866|NCT01055704|P4|Participant Flow|Placebo|
374867|NCT01055704|P3|Participant Flow|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374868|NCT01055704|P2|Participant Flow|Codeine 30 mg|
374869|NCT01055704|P1|Participant Flow|Methylnaltrexone 0.30 mg/kg|
374870|NCT01055704|O4|Outcome|Placebo|
374871|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374872|NCT01055704|O2|Outcome|Codeine 30 mg|
374873|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374874|NCT01055704|O4|Outcome|Placebo|
374875|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374876|NCT01055704|O2|Outcome|Codeine 30 mg|
374877|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374878|NCT01055704|O4|Outcome|Placebo|
374879|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374880|NCT01055704|O2|Outcome|Codeine 30 mg|
374881|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374882|NCT01055704|O4|Outcome|Placebo|
374883|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374884|NCT01055704|O2|Outcome|Codeine 30 mg|
374885|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374886|NCT01055704|O4|Outcome|Placebo|
374887|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374888|NCT01055704|O2|Outcome|Codeine 30 mg|
374889|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374890|NCT01055704|O4|Outcome|Placebo|
374891|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374892|NCT01055704|O2|Outcome|Codeine 30 mg|
374893|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374894|NCT01055704|O4|Outcome|Placebo|
374895|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374896|NCT01055704|O2|Outcome|Codeine 30 mg|
374897|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374898|NCT01055704|O4|Outcome|Placebo|
374899|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374900|NCT01055704|O2|Outcome|Codeine 30 mg|
374901|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
374902|NCT01055704|E4|Reported Event|Placebo|
374903|NCT01055704|E3|Reported Event|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
374904|NCT01055704|E2|Reported Event|Codeine 30 mg|
374905|NCT01055704|E1|Reported Event|Methylnaltrexone 0.30 mg/kg|
374906|NCT01055639|B3|Baseline|Total|Total of all reporting groups
374907|NCT01055639|B2|Baseline|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374908|NCT01055639|B1|Baseline|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374909|NCT01055639|P2|Participant Flow|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374910|NCT01055639|P1|Participant Flow|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374911|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374912|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
375110|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
374913|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374914|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374915|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374916|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374917|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374918|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374919|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374920|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374921|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374922|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374923|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374924|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374925|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374926|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374927|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374928|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374929|NCT01055639|E2|Reported Event|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374930|NCT01055639|E1|Reported Event|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
374931|NCT01055613|B3|Baseline|Total|Total of all reporting groups
374932|NCT01055613|B2|Baseline|ReNu Multi-purpose Solution|Marketed multi-purpose solution (Control Treatment).
374933|NCT01055613|B1|Baseline|Experimental Mutli-purpose Solution|Experimental multi-purpose solution (Test treatment) .
375111|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
374934|NCT01055613|P2|Participant Flow|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
374935|NCT01055613|P1|Participant Flow|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
374936|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
374937|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
374938|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
374939|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
374940|NCT01055613|E2|Reported Event|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
374941|NCT01055613|E1|Reported Event|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
374942|NCT01055457|B11|Baseline|Total|Total of all reporting groups
374943|NCT01055457|B10|Baseline|Solution 2 (Galyfilcon A)|All subjects that were dispensed solution 2 and the galyfilcon A study lens.
374944|NCT01055457|B9|Baseline|Solution 2 (Lotrafilcon A)|All subjects that were dispensed solution 2 and the lotrafilcon A study lens.
374945|NCT01055457|B8|Baseline|Solution 2 (Balafilcon A)|All subjects that were dispensed solution 2 and balafilcon A study lens.
374946|NCT01055457|B7|Baseline|Solution 2 (Comfilcon A)|All subjects that were dispensed solution 2 and the comfilcon A study lens.
374947|NCT01055457|B6|Baseline|Solution 2 (Etafilcon A)|All subjects that were dispensed solution 2 and etafilcon A study lens.
374948|NCT01055457|B5|Baseline|Solution 1 (Galyfilcon A)|All subjects that were dispensed solution 1 and the galyfilcon A study lens.
374949|NCT01055457|B4|Baseline|Solution 1 (Lotrafilcon A)|All subjects that were dispensed solution 1 and the lotrafilcon A study lens.
374950|NCT01055457|B3|Baseline|Solution 1 (Balafilcon A)|All subjects that were dispensed solution 1 and the balafilcon A study lens.
374951|NCT01055457|B2|Baseline|Solution 1 (Comfilcon A)|All subjects that were dispensed solution 1 and the comfilcon A study lens.
374952|NCT01055457|B1|Baseline|Solution 1 (Etafilcon A)|All subjects that were dispensed solution 1 and the etafilcon A lens.
374953|NCT01055457|P10|Participant Flow|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374954|NCT01055457|P9|Participant Flow|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374955|NCT01055457|P8|Participant Flow|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374956|NCT01055457|P7|Participant Flow|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374957|NCT01055457|P6|Participant Flow|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374958|NCT01055457|P5|Participant Flow|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374959|NCT01055457|P4|Participant Flow|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374960|NCT01055457|P3|Participant Flow|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374961|NCT01055457|P2|Participant Flow|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374962|NCT01055457|P1|Participant Flow|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374963|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374964|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374965|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374966|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374967|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374968|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374969|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374970|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
375112|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
374971|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374972|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374973|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374974|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374975|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374976|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374977|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374978|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374979|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374980|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374981|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374982|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374983|NCT01055457|E10|Reported Event|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374984|NCT01055457|E9|Reported Event|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374985|NCT01055457|E8|Reported Event|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374986|NCT01055457|E7|Reported Event|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374987|NCT01055457|E6|Reported Event|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
374988|NCT01055457|E5|Reported Event|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374989|NCT01055457|E4|Reported Event|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374990|NCT01055457|E3|Reported Event|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374991|NCT01055457|E2|Reported Event|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374992|NCT01055457|E1|Reported Event|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
374993|NCT01055314|B3|Baseline|Total|Total of all reporting groups
374994|NCT01055314|B2|Baseline|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
374995|NCT01055314|B1|Baseline|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
374996|NCT01055314|P2|Participant Flow|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
374997|NCT01055314|P1|Participant Flow|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
374998|NCT01055314|O2|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
374999|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
375000|NCT01055314|O2|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
375001|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
375002|NCT01055314|O2|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
375003|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
375004|NCT01055314|O1|Outcome|Temozolomide|Add temozolomide to vincristine/irinotecan cycles.
375005|NCT01055314|O1|Outcome|IMC-A12|IMC-A12 + Multi-agent intensive chemotherapy regimen.
375029|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
375113|NCT01054976|E1|Reported Event|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
375575|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375006|NCT01055314|E2|Reported Event|Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)|"Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50.~Cyclophosphamide: Given IV~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temozolomide: Given PO~Vincristine Sulfate Liposome: Given IV"
375007|NCT01055314|E1|Reported Event|Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)|"Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50 & 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47 & 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, & 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28 & 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 & 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41 & 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24.~Cixutumumab: Given IV~Cyclophosphamide: Given IV~Dactinomycin: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Irinotecan Hydrochloride: Given IV~Laboratory Biomarker Analysis: Correlative studies~Vincristine Sulfate"
375008|NCT01055262|B1|Baseline|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375009|NCT01055262|P1|Participant Flow|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375010|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375011|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375012|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375013|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375014|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375015|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375016|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375017|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375018|NCT01055262|E1|Reported Event|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
375019|NCT01055223|B1|Baseline|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
375020|NCT01055223|P1|Participant Flow|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
375021|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
375022|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375023|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375024|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
375025|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
375026|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375027|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375028|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
375030|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375031|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375032|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
375033|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
375034|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375035|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375036|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
375037|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolacton, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
375038|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375039|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375040|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
375041|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
375042|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
375043|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
375044|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
375045|NCT01055223|E2|Reported Event|TZD-12 Month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
375046|NCT01055223|E1|Reported Event|TZD 6-month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
375047|NCT01055197|B3|Baseline|Total|Total of all reporting groups
375048|NCT01055197|B2|Baseline|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
375049|NCT01055197|B1|Baseline|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
375050|NCT01055197|P2|Participant Flow|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
375051|NCT01055197|P1|Participant Flow|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
375052|NCT01055197|O2|Outcome|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
375053|NCT01055197|O1|Outcome|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
375054|NCT01055197|E2|Reported Event|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
375055|NCT01055197|E1|Reported Event|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
375056|NCT01055184|B1|Baseline|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
375057|NCT01055184|P1|Participant Flow|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
375058|NCT01055184|O1|Outcome|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
375106|NCT01054976|B1|Baseline|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
375107|NCT01054976|P1|Participant Flow|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
375059|NCT01055184|E1|Reported Event|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
375060|NCT01055171|B3|Baseline|Total|Total of all reporting groups
375061|NCT01055171|B2|Baseline|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
375062|NCT01055171|B1|Baseline|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
375063|NCT01055171|P2|Participant Flow|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
375064|NCT01055171|P1|Participant Flow|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
375065|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
375066|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
375067|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
375068|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
375069|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
375070|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
375071|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
375072|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
375073|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
375074|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
375075|NCT01055171|E2|Reported Event|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
375076|NCT01055171|E1|Reported Event|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
375077|NCT01055132|B1|Baseline|All Subjects|All subjects who completed the study.
375078|NCT01055132|P2|Participant Flow|Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second|Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
375079|NCT01055132|P1|Participant Flow|Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second|Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days
375080|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days.
375081|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
375082|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days
375083|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn 5-9 days
375084|NCT01055132|O2|Outcome|Nelfilcon A Toric Lens (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
375085|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
375086|NCT01055132|O2|Outcome|Nelfilcon A Toric (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
375087|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
375088|NCT01055132|E1|Reported Event|Etafilcon A Toric / Nelfilcon A Toric|etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days
375089|NCT01055028|B3|Baseline|Total|Total of all reporting groups
375090|NCT01055028|B2|Baseline|Regimen B Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375576|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375091|NCT01055028|B1|Baseline|Regimen A Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375092|NCT01055028|P2|Participant Flow|Regimen B Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375093|NCT01055028|P1|Participant Flow|Regimen A Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375094|NCT01055028|O2|Outcome|Regimen B / Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.~Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles.~Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.~Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle"
375095|NCT01055028|O1|Outcome|Regimen A / Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.~Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles.~Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.~Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle"
375096|NCT01055028|O2|Outcome|Regimen B / Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.~Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles.~Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.~Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle"
375097|NCT01055028|O1|Outcome|Regimen A / Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.~Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles.~Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.~Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle"
375098|NCT01055028|O2|Outcome|Regimen B Treatment 2|Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
375099|NCT01055028|O1|Outcome|Regimen A Treatment 1|Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
375100|NCT01055028|O2|Outcome|Regimen B Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375101|NCT01055028|O1|Outcome|Regimen A Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375102|NCT01055028|O2|Outcome|Regimen B Treatment 2|"Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375103|NCT01055028|O1|Outcome|Regimen A Treatment 1|"Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.~Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination."
375104|NCT01055028|E2|Reported Event|Regimen B Treatment 2|Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
375105|NCT01055028|E1|Reported Event|Regimen A Treatment 1|Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
375114|NCT01054911|B1|Baseline|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
375115|NCT01054911|P1|Participant Flow|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
375116|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
375117|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
375118|NCT01054911|O2|Outcome|Neoadjuvant Therapy no Surgery|Patients received oral therapy for up to 12 weeks. Reassessment demonstrated response, but no surgical intervention
375119|NCT01054911|O1|Outcome|Neoadjuvant Therapy Plus Surgery|Patients received oral therapy for up to 12 weeks and re-evaluated for response. Favorable tumor reduction resulted surgical extirpation typically with less morbid operative intervention.
375120|NCT01054911|E1|Reported Event|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
375121|NCT01054885|B7|Baseline|Total|Total of all reporting groups
375122|NCT01054885|B6|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375123|NCT01054885|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375124|NCT01054885|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375125|NCT01054885|B3|Baseline|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375126|NCT01054885|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375127|NCT01054885|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375128|NCT01054885|P7|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375129|NCT01054885|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375130|NCT01054885|P5|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
375131|NCT01054885|P4|Participant Flow|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375132|NCT01054885|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
375133|NCT01054885|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
375134|NCT01054885|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
375135|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375136|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375137|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375138|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375139|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375140|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375141|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375142|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375143|NCT01054885|O4|Outcome|FVI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375144|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375145|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375146|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375147|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375148|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375149|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375150|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375151|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375152|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375153|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375154|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375155|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375156|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375157|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375158|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375159|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375160|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375161|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375162|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375163|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375164|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375165|NCT01054885|E6|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
375166|NCT01054885|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375167|NCT01054885|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375168|NCT01054885|E3|Reported Event|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
375169|NCT01054885|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375170|NCT01054885|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375171|NCT01054846|B3|Baseline|Total|Total of all reporting groups
375172|NCT01054846|B2|Baseline|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
375173|NCT01054846|B1|Baseline|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
375174|NCT01054846|P2|Participant Flow|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
375175|NCT01054846|P1|Participant Flow|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
375176|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
375177|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
375178|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
375179|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
375180|NCT01054846|E1|Reported Event|All Study Participants|
375181|NCT01054820|B1|Baseline|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375182|NCT01054820|P1|Participant Flow|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375183|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375184|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375185|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375186|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375187|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375188|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375189|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375190|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375191|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375192|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375193|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375194|NCT01054820|E1|Reported Event|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
375195|NCT01054742|B1|Baseline|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
375196|NCT01054742|P1|Participant Flow|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
375197|NCT01054742|O1|Outcome|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
375198|NCT01054742|E1|Reported Event|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
375199|NCT01054729|B5|Baseline|Total|Total of all reporting groups
375200|NCT01054729|B4|Baseline|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
375201|NCT01054729|B3|Baseline|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375202|NCT01054729|B2|Baseline|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375203|NCT01054729|B1|Baseline|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375204|NCT01054729|P4|Participant Flow|Placebo+PEG+RBV|Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
375205|NCT01054729|P3|Participant Flow|Sofosbuvir 400 mg+PEG+RBV|Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
375206|NCT01054729|P2|Participant Flow|Sofosbuvir 200 mg+PEG+RBV|Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
375207|NCT01054729|P1|Participant Flow|Sofosbuvir 100 mg+PEG+RBV|Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
375208|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375209|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375210|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375211|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375212|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375213|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375214|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375215|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375216|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375217|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375218|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375219|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375220|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375221|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375222|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375223|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375224|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375225|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375226|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375227|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375228|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375229|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375230|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375231|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375232|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375233|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375234|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375235|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375236|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375237|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375238|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375239|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375240|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375241|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375242|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375243|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375244|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375245|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375246|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375247|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
375248|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375249|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375250|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375251|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
375252|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375253|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375254|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375255|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
375256|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375257|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375258|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375259|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
375260|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375261|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375262|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375263|NCT01054729|E4|Reported Event|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
375264|NCT01054729|E3|Reported Event|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
375265|NCT01054729|E2|Reported Event|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
375266|NCT01054729|E1|Reported Event|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
375267|NCT01054703|B1|Baseline|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
375268|NCT01054703|P1|Participant Flow|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
375269|NCT01054703|O1|Outcome|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
375270|NCT01054703|E1|Reported Event|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
375271|NCT01054625|B4|Baseline|Total|Total of all reporting groups
375272|NCT01054625|B3|Baseline|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375273|NCT01054625|B2|Baseline|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375274|NCT01054625|B1|Baseline|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375275|NCT01054625|P3|Participant Flow|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375276|NCT01054625|P2|Participant Flow|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375277|NCT01054625|P1|Participant Flow|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375278|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375279|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375280|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375281|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375282|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375283|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375284|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375285|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375286|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375287|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375288|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375289|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375290|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375291|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375292|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375293|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375294|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375295|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375296|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375297|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375298|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375299|NCT01054625|E3|Reported Event|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
375300|NCT01054625|E2|Reported Event|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
375301|NCT01054625|E1|Reported Event|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
375302|NCT01054599|B3|Baseline|Total|Total of all reporting groups
375303|NCT01054599|B2|Baseline|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
375304|NCT01054599|B1|Baseline|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
375305|NCT01054599|P2|Participant Flow|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
375306|NCT01054599|P1|Participant Flow|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
375339|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375340|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
375341|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375342|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375343|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375307|NCT01054599|O2|Outcome|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
375308|NCT01054599|O1|Outcome|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
375309|NCT01054599|O2|Outcome|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
375310|NCT01054599|O1|Outcome|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
375311|NCT01054599|E2|Reported Event|Sugar Pill|"Subjects will be randomly assigned to take either memantine or a placebo. The study is double-blind, and neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Sugar Pill: In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study"
375312|NCT01054599|E1|Reported Event|Memantine|"Subjects will randomly assigned to take either a placebo or memantine for 13 weeks. The assignment will be double-blind, neither the study members nor the subject will know if he/she is taking memantine or a placebo.~Memantine: The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase."
375313|NCT01054586|B5|Baseline|Total|Total of all reporting groups
375314|NCT01054586|B4|Baseline|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375315|NCT01054586|B3|Baseline|FPV, Other|All other dosages of Fosamprenavir
375316|NCT01054586|B2|Baseline|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375317|NCT01054586|B1|Baseline|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375318|NCT01054586|P4|Participant Flow|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375319|NCT01054586|P3|Participant Flow|FPV, Other|All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD)
375320|NCT01054586|P2|Participant Flow|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375321|NCT01054586|P1|Participant Flow|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375322|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375323|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375324|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
375325|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
375326|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375327|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375328|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
375329|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
375330|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
375331|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
375332|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375333|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375334|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
375335|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375336|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375337|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375338|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
375344|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375345|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
375346|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375347|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375348|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375349|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
375350|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375351|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375352|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375353|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
375354|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375355|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375356|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375357|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375358|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375359|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
375360|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
375361|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375362|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375363|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
375364|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
375365|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375366|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375367|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
375368|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
375369|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375370|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375371|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
375372|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
375373|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375374|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375375|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
375376|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|
375377|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
375378|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375379|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
375380|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375381|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375382|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375383|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375384|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375385|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375386|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375387|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375388|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375389|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375390|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
375391|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375392|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375393|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375394|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375395|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375396|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375397|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375398|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375399|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375400|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375401|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375402|NCT01054586|O2|Outcome|Not ART naïve|Patients who have previously been exposed to ART therapy
375403|NCT01054586|O1|Outcome|ART naïve|Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
375404|NCT01054586|E4|Reported Event|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
375405|NCT01054586|E3|Reported Event|FPV, Other|All other dosages of Fosamprenavir
375406|NCT01054586|E2|Reported Event|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
375407|NCT01054586|E1|Reported Event|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
375409|NCT01054573|B4|Baseline|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375410|NCT01054573|B3|Baseline|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375411|NCT01054573|B2|Baseline|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375412|NCT01054573|B1|Baseline|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375413|NCT01054573|P4|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375414|NCT01054573|P3|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375415|NCT01054573|P2|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375416|NCT01054573|P1|Participant Flow|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375417|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 8, 7, and 7, respectively.
375418|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 26, 26, 26, 24, 23, and 21, respectively.
375419|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 20, 19, and 16, respectively.
375420|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 31, 23, 18, and 15, respectively.
375421|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 9, 9, 8, 7, and 7, respectively.
375422|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 27, 26, 26, 26, 24, 23, and 21, respectively.
375423|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 22, 20, 19, and 16, respectively.
375424|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 32, 31, 23, 18, and 16, respectively.
375425|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375577|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375426|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375427|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375428|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375429|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375430|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375431|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375432|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375433|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375434|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375435|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375436|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375437|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375438|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375439|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375440|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375441|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375442|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375443|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375444|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375475|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375445|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375446|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375447|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375448|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375449|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375450|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375451|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375452|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375453|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375454|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
375455|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
375456|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
375457|NCT01054573|E2|Reported Event|Phase 3: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers).
375458|NCT01054573|E1|Reported Event|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
375459|NCT01054560|B3|Baseline|Total|Total of all reporting groups
375460|NCT01054560|B2|Baseline|MERCI® Device|The MERCI® Device (control device) is commercially available.
375461|NCT01054560|B1|Baseline|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375462|NCT01054560|P2|Participant Flow|MERCI® Device|The MERCI® Device (control device) is commercially available.
375463|NCT01054560|P1|Participant Flow|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375464|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
375465|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
375466|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
375467|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
375468|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
375469|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
375470|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
375471|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375472|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
375473|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375474|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
375476|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
375477|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375478|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
375479|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375480|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
375481|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375482|NCT01054560|E2|Reported Event|The MERCI® Device|The MERCI® Device (control device) is commercially available.
375483|NCT01054560|E1|Reported Event|The SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
375484|NCT01054404|B3|Baseline|Total|Total of all reporting groups
375485|NCT01054404|B2|Baseline|Placebo|Placebo : Placebo (up to 5mL)
375486|NCT01054404|B1|Baseline|Furosemide|Furosemide : Furosemide 0.3 mg/kg
375487|NCT01054404|P2|Participant Flow|Placebo|Placebo : Placebo (up to 5mL)
375488|NCT01054404|P1|Participant Flow|Furosemide|Furosemide : Furosemide 0.3 mg/kg
375489|NCT01054404|O2|Outcome|Placebo|Placebo : Placebo (up to 5mL)
375490|NCT01054404|O1|Outcome|Furosemide|Furosemide : Furosemide 0.3 mg/kg
375491|NCT01054404|E2|Reported Event|Placebo|Placebo : Placebo (up to 5mL)
375492|NCT01054404|E1|Reported Event|Furosemide|Furosemide : Furosemide 0.3 mg/kg
375493|NCT01054339|B4|Baseline|Total|Total of all reporting groups
375494|NCT01054339|B3|Baseline|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
375495|NCT01054339|B2|Baseline|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
375496|NCT01054339|B1|Baseline|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
375497|NCT01054339|P3|Participant Flow|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
375498|NCT01054339|P2|Participant Flow|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
375499|NCT01054339|P1|Participant Flow|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
375500|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
375501|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
375502|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
375503|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
375504|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
375505|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
375506|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
375507|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
375508|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
375509|NCT01054339|E3|Reported Event|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
375510|NCT01054339|E2|Reported Event|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
375511|NCT01054339|E1|Reported Event|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
375512|NCT01054222|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375513|NCT01054222|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375514|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375515|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375516|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375517|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375518|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375519|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375520|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375572|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375521|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375522|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375523|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375524|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375525|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375526|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375527|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375528|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375529|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375530|NCT01054222|E1|Reported Event|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
375531|NCT01054183|B3|Baseline|Total|Total of all reporting groups
375532|NCT01054183|B2|Baseline|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
375533|NCT01054183|B1|Baseline|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
375534|NCT01054183|P2|Participant Flow|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
375535|NCT01054183|P1|Participant Flow|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
375536|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
375537|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
375538|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
375539|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
375540|NCT01054183|E2|Reported Event|Direct Laryngoscopy|Procedure used to visualize the vocal cords and perform tracheal intubation in the pediatric and neonatal population.
375541|NCT01054183|E1|Reported Event|GlideScope Video Laryngoscope Ranger(GVL)|Procedure used to perform tracheal intubation that facilitates indirect visualization of the glottis through a video display.
375542|NCT01054170|B3|Baseline|Total|Total of all reporting groups
375543|NCT01054170|B2|Baseline|Placebo|Placebo 2 tablets bid
375544|NCT01054170|B1|Baseline|AZD9668|AZD9668 2x30mg bid
375545|NCT01054170|P2|Participant Flow|Placebo|Placebo 2 tablets bid
375546|NCT01054170|P1|Participant Flow|AZD9668|AZD9668 2x30mg bid
375547|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375548|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375549|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375550|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375551|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375552|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375553|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375554|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375555|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375556|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375557|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375558|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375559|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375560|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375561|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375562|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375563|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375564|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375565|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375566|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375567|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375568|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375569|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375570|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375571|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375578|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375579|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375580|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375581|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375582|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375583|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375584|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375585|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375586|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375587|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375588|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375589|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375590|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375591|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375592|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375593|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
375594|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
375595|NCT01054170|E2|Reported Event|Placebo|Placebo 2 tablets bid
375596|NCT01054170|E1|Reported Event|AZD9668|AZD9668 2x30mg bid
375597|NCT01054079|B1|Baseline|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375598|NCT01054079|P1|Participant Flow|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375599|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375600|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375601|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375602|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375603|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375604|NCT01054079|E1|Reported Event|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
375605|NCT01053988|B6|Baseline|Total|Total of all reporting groups
375606|NCT01053988|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375607|NCT01053988|B4|Baseline|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375608|NCT01053988|B3|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375609|NCT01053988|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375610|NCT01053988|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375611|NCT01053988|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375612|NCT01053988|P5|Participant Flow|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375613|NCT01053988|P4|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
375614|NCT01053988|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
375615|NCT01053988|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
375616|NCT01053988|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
375617|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375618|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375619|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375620|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375621|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375622|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375623|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375624|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
376036|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
375625|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375626|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375627|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375628|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375629|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375630|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375631|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375632|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375633|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375634|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375635|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375636|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375637|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375638|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375639|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375640|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375641|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375642|NCT01053988|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
375643|NCT01053988|E4|Reported Event|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
375644|NCT01053988|E3|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
375645|NCT01053988|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
375646|NCT01053988|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
375647|NCT01053897|B1|Baseline|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
375648|NCT01053897|P1|Participant Flow|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
375649|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
375650|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
375651|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
375652|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
375653|NCT01053897|O3|Outcome|No Difference|No scar segment was preferred to the other
375654|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment preferred
375655|NCT01053897|O1|Outcome|GBT009|GBT009 treated scar segment preferred
375656|NCT01053897|O2|Outcome|Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
375657|NCT01053897|O1|Outcome|GBT009|All subjects acted as their own control receiving both GBT009 and Placebo
375658|NCT01053897|E1|Reported Event|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
375659|NCT01053819|B1|Baseline|Etanercept|open label treatment per FDA approval for 24 weeks
375660|NCT01053819|P1|Participant Flow|Etanercept|Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.
375661|NCT01053819|O1|Outcome|Etanercept|Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.
375662|NCT01053819|O1|Outcome|Etanercept|open label treatment per FDA approval for 24 weeks
375663|NCT01053819|E1|Reported Event|Etanercept|open label treatment per FDA approval for 24 weeks
375664|NCT01053741|B3|Baseline|Total|Total of all reporting groups
375665|NCT01053741|B2|Baseline|Normosol-R Then Seminal Fluid|"2.5 mL radiolabeled Normosol-R administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled autologous seminal fluid administered rectally X1.~Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.~Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
375666|NCT01053741|B1|Baseline|Seminal Fluid Then Normosol|"2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled Normosol-R administered rectally X1.~Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.~Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
375667|NCT01053741|P2|Participant Flow|Normosol-R Then Seminal Fluid|Subjects first received 2.5 mL radiolabeled Normosol-R administered rectally x1. Then a two week pause between interventions. Followed by 2.5 mL radiolabeled autologous seminal fluid administered rectally x1.
375668|NCT01053741|P1|Participant Flow|Seminal Fluid, Then Normosol-R|Subjects first received 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Than a two week pause between interventions. Followed by 2.5 mL radiolabeled Normosol-R administered rectally x1.
375669|NCT01053741|O2|Outcome|Normosol-R|Normosol-R Intervention
375670|NCT01053741|O1|Outcome|Seminal Fluid|Seminal Fluid Intervention
375671|NCT01053741|E2|Reported Event|Normosol-R|Normosol-R Intervention
375672|NCT01053741|E1|Reported Event|Seminal Fluid|Seminal Fluid Intervention
375673|NCT01053663|B4|Baseline|Total|Total of all reporting groups
375748|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
375674|NCT01053663|B3|Baseline|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375675|NCT01053663|B2|Baseline|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375676|NCT01053663|B1|Baseline|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375677|NCT01053663|P1|Participant Flow|Oseltamivir - All Participants|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375678|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375679|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375680|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375681|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375682|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375683|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375684|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375685|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375686|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375687|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375688|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375689|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375690|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375691|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375692|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375693|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375694|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375695|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375696|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375697|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375698|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375699|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375700|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375701|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375702|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375703|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375704|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
376104|NCT01052116|B1|Baseline|Placebo|"Matching placebo~Tablet twice a day"
375705|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375706|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375707|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375708|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375709|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375710|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375711|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375712|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375713|NCT01053663|E4|Reported Event|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375714|NCT01053663|E3|Reported Event|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375715|NCT01053663|E2|Reported Event|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375716|NCT01053663|E1|Reported Event|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
375717|NCT01053507|B3|Baseline|Total|Total of all reporting groups
375718|NCT01053507|B2|Baseline|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375719|NCT01053507|B1|Baseline|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375720|NCT01053507|P2|Participant Flow|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375721|NCT01053507|P1|Participant Flow|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
376140|NCT01052038|B4|Baseline|Total|Total of all reporting groups
375722|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375723|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375724|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375725|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375726|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375727|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375728|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375729|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375730|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375731|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375732|NCT01053507|E2|Reported Event|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375733|NCT01053507|E1|Reported Event|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
375734|NCT01053429|B1|Baseline|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375735|NCT01053429|P1|Participant Flow|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375736|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375737|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375738|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375739|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375740|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375741|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375742|NCT01053429|E1|Reported Event|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
375743|NCT01053312|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
375744|NCT01053312|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
375745|NCT01053312|O1|Outcome|Amyloid Level (Plaque Load)|Amlyoid level estimate from the Immunohistochemistry assay: Percent plaque area (average across slides) for mAb NAB228.
375746|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
375747|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
375749|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
375750|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
375751|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
375752|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
375753|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
375754|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
375755|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
375756|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
375757|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
375758|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
375759|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
375760|NCT01053312|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
375761|NCT01053247|B4|Baseline|Total|Total of all reporting groups
375762|NCT01053247|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
375763|NCT01053247|B2|Baseline|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
375764|NCT01053247|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
375765|NCT01053247|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
375766|NCT01053247|P2|Participant Flow|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
375767|NCT01053247|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
375768|NCT01053247|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
375769|NCT01053247|O2|Outcome|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
375770|NCT01053247|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
375771|NCT01053247|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
375772|NCT01053247|E2|Reported Event|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
375773|NCT01053247|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
375774|NCT01053156|B3|Baseline|Total|Total of all reporting groups
375775|NCT01053156|B2|Baseline|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
375776|NCT01053156|B1|Baseline|Minocycline First, Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
375777|NCT01053156|P2|Participant Flow|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
375778|NCT01053156|P1|Participant Flow|Minocycline First, Then Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
375779|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375780|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375781|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375782|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375783|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375784|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375785|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375786|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375787|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375788|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375789|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375790|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375791|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375792|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375793|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375794|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375795|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375796|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375797|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375798|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375799|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375800|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375801|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375802|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375803|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375804|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375805|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375806|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375807|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375808|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
375809|NCT01053156|O2|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375810|NCT01053156|O1|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375811|NCT01053156|E2|Reported Event|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375812|NCT01053156|E1|Reported Event|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
375813|NCT01053078|B3|Baseline|Total|Total of all reporting groups
375814|NCT01053078|B2|Baseline|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375815|NCT01053078|B1|Baseline|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375816|NCT01053078|P2|Participant Flow|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375817|NCT01053078|P1|Participant Flow|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375818|NCT01053078|O2|Outcome|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375819|NCT01053078|O1|Outcome|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375820|NCT01053078|E2|Reported Event|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375821|NCT01053078|E1|Reported Event|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
375822|NCT01053000|B1|Baseline|All Study Participants|"Tazorac o.1% gel foer 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
375823|NCT01053000|P2|Participant Flow|Right Arm Tazorac/Left Arm No Pretreatment|Tazorac 0.1% gel was applied for 1 week to the right arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
375824|NCT01053000|P1|Participant Flow|Left Arm Tazorac/Right Arm No Tazorac Pre-treatment|Tazorac 0.1% gel was applied for 1 week to the left arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
375825|NCT01053000|O2|Outcome|No Pretreatment With Tzorac|"No pretreatmnet to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
375826|NCT01053000|O1|Outcome|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
375827|NCT01053000|E2|Reported Event|No Pretreatment Arm|"No Pretreatment to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
375828|NCT01053000|E1|Reported Event|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
375829|NCT01052948|B5|Baseline|Total|Total of all reporting groups
375830|NCT01052948|B4|Baseline|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
375831|NCT01052948|B3|Baseline|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
375832|NCT01052948|B2|Baseline|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
375833|NCT01052948|B1|Baseline|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
375834|NCT01052948|P4|Participant Flow|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
375835|NCT01052948|P3|Participant Flow|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
375836|NCT01052948|P2|Participant Flow|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
375837|NCT01052948|P1|Participant Flow|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
375838|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
375839|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
375840|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
375841|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
375842|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
375843|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
375844|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
375845|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
375846|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
375847|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
375848|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
375849|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
375850|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
375851|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
375852|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
375853|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
375854|NCT01052948|E4|Reported Event|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
375855|NCT01052948|E3|Reported Event|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
375856|NCT01052948|E2|Reported Event|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
375857|NCT01052948|E1|Reported Event|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
375858|NCT01052844|B3|Baseline|Total|Total of all reporting groups
375859|NCT01052844|B2|Baseline|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375860|NCT01052844|B1|Baseline|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375861|NCT01052844|P2|Participant Flow|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375862|NCT01052844|P1|Participant Flow|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375863|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375864|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375865|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375866|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375867|NCT01052844|E2|Reported Event|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
376037|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
375868|NCT01052844|E1|Reported Event|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
375869|NCT01052831|B3|Baseline|Total|Total of all reporting groups
375870|NCT01052831|B2|Baseline|Placebo|"Participants will receive placebo treatment~Placebo: 50-100 mg qd for 8 weeks"
375871|NCT01052831|B1|Baseline|Naltrexone|"Participants will receive Naltrexone~Naltrexone: 50-100 mg qd for 8 weeks"
375872|NCT01052831|P2|Participant Flow|Placebo|Participants received the placebo treatment which looked identical to active study medication.
375873|NCT01052831|P1|Participant Flow|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
375874|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
375875|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
375876|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
375877|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
375878|NCT01052831|E2|Reported Event|Placebo|Participants received the placebo treatment which looked identical to active study medication.
375879|NCT01052831|E1|Reported Event|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
375880|NCT01052779|B3|Baseline|Total|Total of all reporting groups
375881|NCT01052779|B2|Baseline|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
375882|NCT01052779|B1|Baseline|Ferumoxytol|Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
375883|NCT01052779|P2|Participant Flow|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
375884|NCT01052779|P1|Participant Flow|Ferumoxytol|Participants received an intravenous (IV) injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
375885|NCT01052779|O2|Outcome|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
375886|NCT01052779|O1|Outcome|Ferumoxytol|Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
375887|NCT01052779|O2|Outcome|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
375888|NCT01052779|O1|Outcome|Ferumoxytol|Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
375889|NCT01052779|E2|Reported Event|Iron Sucrose|"Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.~Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g."
375890|NCT01052779|E1|Reported Event|Ferumoxytol|Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
375891|NCT01052714|B3|Baseline|Total|Total of all reporting groups
375892|NCT01052714|B2|Baseline|Lifestyle Balance|"Weight management group education and individual counseling~Lifestyle Balance: Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition"
376038|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
375893|NCT01052714|B1|Baseline|Usual Care|"Control group with time-matched study visits~Includes 17 participants who would later join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention."
375894|NCT01052714|P3|Participant Flow|Usual Care Then Lifestyle Balance|"Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.~Patients randomized to the Lifestyle Balance Program will do the following:~Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
375895|NCT01052714|P2|Participant Flow|Lifestyle Balance|"Weight management group education and individual counseling~Patients randomized to the Lifestyle Balance Program will do the following:~Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
375896|NCT01052714|P1|Participant Flow|Usual Care|Control group with time-matched study visits
375897|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375898|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375899|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375900|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375901|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375902|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375903|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375904|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375905|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375906|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375907|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375908|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375909|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375910|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375911|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375912|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375913|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375914|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375915|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375916|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375917|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375918|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375919|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375920|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375921|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375922|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375923|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375924|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375925|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375926|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375927|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375928|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375929|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375930|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375931|NCT01052714|O2|Outcome|Lifestyle Balance|Weight management group education and individual counseling to review goals and diet and exercise journals.
375932|NCT01052714|O1|Outcome|Usual Care|Control group with time-matched study visits.
375933|NCT01052714|E2|Reported Event|Lifestyle Balance|"Weight management group education and individual counseling~Lifestyle Balance: Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition"
375934|NCT01052714|E1|Reported Event|Usual Care|Control group with time-matched study visits
375935|NCT01052701|B3|Baseline|Total|Total of all reporting groups
376039|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
375936|NCT01052701|B2|Baseline|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
375937|NCT01052701|B1|Baseline|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
375938|NCT01052701|P2|Participant Flow|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
375939|NCT01052701|P1|Participant Flow|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
375940|NCT01052701|O2|Outcome|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
375941|NCT01052701|O1|Outcome|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
375942|NCT01052701|O2|Outcome|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
375943|NCT01052701|O1|Outcome|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
375944|NCT01052701|E2|Reported Event|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
375945|NCT01052701|E1|Reported Event|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
375946|NCT01052662|B4|Baseline|Total|Total of all reporting groups
375947|NCT01052662|B3|Baseline|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
375948|NCT01052662|B2|Baseline|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
375949|NCT01052662|B1|Baseline|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
375950|NCT01052662|P3|Participant Flow|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
375951|NCT01052662|P2|Participant Flow|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
376000|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376001|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376040|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
375952|NCT01052662|P1|Participant Flow|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
375953|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
375954|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
375955|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
375956|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
375957|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
375958|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
375959|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
375960|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
375961|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
376041|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
376042|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
375962|NCT01052662|E3|Reported Event|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
375963|NCT01052662|E2|Reported Event|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
375964|NCT01052662|E1|Reported Event|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
375965|NCT01052545|B3|Baseline|Total|Total of all reporting groups
375966|NCT01052545|B2|Baseline|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
375967|NCT01052545|B1|Baseline|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
375968|NCT01052545|P2|Participant Flow|Arm 2- Control|This was the contemporary control group. Surveillance for the outcomes of interest (urine cultures order and antibiotics used to treat urine cultures) continued for all 3 years. Providers at this site received standard education about the CAUTI and asymptomatic bacteriuria guidelines delivered in a grand rounds format, and they also received a PDF of the full guidelines by email.
375969|NCT01052545|P1|Participant Flow|Arm 1- Intervention: Audit-Feedback|"Year 1: baseline surveillance at both sites Year 2: case based, individual audit and feedback delivered to providers, a guidelines based diagnostic algorithm for CAUTI versus asymptomatic bacteriuria (ASB) was given to providers and reinforced in the audit and feedback sessions.~Year 3: cased based, group audit and feedback delivered to providers, again based on this dignostic algorithm.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
375970|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
375971|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
375972|NCT01052545|O2|Outcome|Control Group|Cases of positive urine cultures on medicine and extended care wards at the control site
375973|NCT01052545|O1|Outcome|Intervention Group|Cases of positive urine cultures on medicine and extended care wards at the intervention site
375974|NCT01052545|O2|Outcome|Control Group|Medicine and extended care wards at control site
375975|NCT01052545|O1|Outcome|Intervention Group|Medicine and extended care wards at the intervention site
375976|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
376002|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376003|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376043|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
376044|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
375977|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
375978|NCT01052545|E2|Reported Event|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
375979|NCT01052545|E1|Reported Event|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
375980|NCT01052480|B3|Baseline|Total|Total of all reporting groups
375981|NCT01052480|B2|Baseline|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375982|NCT01052480|B1|Baseline|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375983|NCT01052480|P2|Participant Flow|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375984|NCT01052480|P1|Participant Flow|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375985|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375986|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375987|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375988|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375989|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375990|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375991|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375992|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375993|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375994|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375995|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375996|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375997|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
375998|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
375999|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376032|NCT01052428|B2|Baseline|Toprol-XL|
376033|NCT01052428|B1|Baseline|Placebo|
376034|NCT01052428|P2|Participant Flow|Toprol-XL|
376035|NCT01052428|P1|Participant Flow|Placebo|
376004|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376005|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376006|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376007|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376008|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376009|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376010|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376011|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376012|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376013|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376014|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376015|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376016|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376017|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376018|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376019|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376020|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376021|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376022|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376023|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376024|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376025|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376026|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376027|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376028|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376029|NCT01052480|E2|Reported Event|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
376030|NCT01052480|E1|Reported Event|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
376031|NCT01052428|B3|Baseline|Total|Total of all reporting groups
376045|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
376046|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
376047|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
376048|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
376049|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
376050|NCT01052428|E2|Reported Event|Toprol-XL|
376051|NCT01052428|E1|Reported Event|Placebo|
376052|NCT01052272|B5|Baseline|Total|Total of all reporting groups
376053|NCT01052272|B4|Baseline|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376054|NCT01052272|B3|Baseline|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376055|NCT01052272|B2|Baseline|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376056|NCT01052272|B1|Baseline|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376057|NCT01052272|P4|Participant Flow|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376058|NCT01052272|P3|Participant Flow|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376059|NCT01052272|P2|Participant Flow|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376060|NCT01052272|P1|Participant Flow|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376061|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376062|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376063|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376064|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376065|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376066|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376067|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376102|NCT01052116|B3|Baseline|Total|Total of all reporting groups
376103|NCT01052116|B2|Baseline|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
376068|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376069|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376070|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376071|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376072|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376073|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376074|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376075|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376076|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376077|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376078|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376079|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376080|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376081|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376082|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376083|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376084|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376085|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376086|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376087|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376088|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376089|NCT01052272|E4|Reported Event|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
376090|NCT01052272|E3|Reported Event|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
376091|NCT01052272|E2|Reported Event|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
376092|NCT01052272|E1|Reported Event|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
376093|NCT01052207|B3|Baseline|Total|Total of all reporting groups
376094|NCT01052207|B2|Baseline|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
376095|NCT01052207|B1|Baseline|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
376096|NCT01052207|P2|Participant Flow|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
376097|NCT01052207|P1|Participant Flow|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
376098|NCT01052207|O2|Outcome|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
376099|NCT01052207|O1|Outcome|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
376100|NCT01052207|E2|Reported Event|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
376101|NCT01052207|E1|Reported Event|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected. only if deemed part of their clinical care"
376105|NCT01052116|P2|Participant Flow|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
376106|NCT01052116|P1|Participant Flow|Placebo|Matching placebo
376107|NCT01052116|O2|Outcome|Placebo|"Matching placebo~Tablet twice daily"
376108|NCT01052116|O1|Outcome|Soy Isoflavone|"Oral soy isoflavone supplement~tablet twice daily (100 mg/day)"
376109|NCT01052116|E2|Reported Event|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
376110|NCT01052116|E1|Reported Event|Placebo|"Matching placebo~Tablet twice a day"
376111|NCT01052077|B3|Baseline|Total|Total of all reporting groups
376112|NCT01052077|B2|Baseline|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376113|NCT01052077|B1|Baseline|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376114|NCT01052077|P4|Participant Flow|Phase A+|Participants who met the criteria for a response at the end of the 8 weeks prospective treatment phase received single-blind placebo + ADT for an additional 6 weeks in Phase A+ for a total of 14 weeks.
376115|NCT01052077|P3|Participant Flow|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376116|NCT01052077|P2|Participant Flow|Brexiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376117|NCT01052077|P1|Participant Flow|Phase A|Participants entered a single-blind prospective treatment phase during which they received single-blind placebo plus open-label commercially available ADT for 8 weeks at maximally tolerated doses.
376118|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376119|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376120|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376121|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376122|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376123|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376124|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376125|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376126|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376127|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376128|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376129|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376130|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376131|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376132|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376133|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376134|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376135|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376136|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376137|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376138|NCT01052077|E2|Reported Event|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
376139|NCT01052077|E1|Reported Event|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
376141|NCT01052038|B3|Baseline|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376142|NCT01052038|B2|Baseline|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376143|NCT01052038|B1|Baseline|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376144|NCT01052038|P3|Participant Flow|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376145|NCT01052038|P2|Participant Flow|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376146|NCT01052038|P1|Participant Flow|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376147|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376148|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376149|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376150|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376151|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376152|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376153|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376154|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376155|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376156|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376157|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376158|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376159|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376160|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376161|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376162|NCT01052038|E3|Reported Event|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
376163|NCT01052038|E2|Reported Event|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
376164|NCT01052038|E1|Reported Event|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
376165|NCT01051986|B3|Baseline|Total|Total of all reporting groups
376166|NCT01051986|B2|Baseline|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376167|NCT01051986|B1|Baseline|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376168|NCT01051986|P2|Participant Flow|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376169|NCT01051986|P1|Participant Flow|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376170|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376171|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376172|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376173|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376240|NCT01051557|B8|Baseline|Total|Total of all reporting groups
376174|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376175|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376176|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376177|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376178|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376179|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376180|NCT01051986|E2|Reported Event|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
376181|NCT01051986|E1|Reported Event|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
376182|NCT01051921|B1|Baseline|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
376183|NCT01051921|P1|Participant Flow|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
376184|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
376185|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
376186|NCT01051921|E1|Reported Event|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
376187|NCT01051856|B3|Baseline|Total|Total of all reporting groups
376188|NCT01051856|B2|Baseline|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
376189|NCT01051856|B1|Baseline|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
376190|NCT01051856|P2|Participant Flow|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
376191|NCT01051856|P1|Participant Flow|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
376192|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
376193|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
376194|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
376195|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
376196|NCT01051856|E2|Reported Event|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
376735|NCT01050660|B3|Baseline|Total|Total of all reporting groups
376197|NCT01051856|E1|Reported Event|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
376198|NCT01051817|B3|Baseline|Total|Total of all reporting groups
376199|NCT01051817|B2|Baseline|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
376200|NCT01051817|B1|Baseline|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
376201|NCT01051817|P2|Participant Flow|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
376202|NCT01051817|P1|Participant Flow|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
376203|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
376204|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
376205|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
376206|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
376207|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
376208|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
376209|NCT01051817|E2|Reported Event|AIN457 10mg/kg|AIN457 10mg/kg
376210|NCT01051817|E1|Reported Event|PLACEBO|PLACEBO
376211|NCT01051791|B1|Baseline|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
376212|NCT01051791|P1|Participant Flow|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
376213|NCT01051791|O1|Outcome|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
376214|NCT01051791|O1|Outcome|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
376215|NCT01051791|O1|Outcome|Everolimus 10 mg Daily|Patients with a planned treatment of continuous 28-day cycles of everolimus 10 mg by mouth daily.
376216|NCT01051791|O1|Outcome|Everolimus 10 mg Daily|Patients that completed at least 1 cycle of everolimus everolimus 10 mg by mouth daily. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.
376217|NCT01051791|E1|Reported Event|Everolimus 10 mg Daily|Patients with any treatment of everolimus 10 mg by mouth daily.
376218|NCT01051778|B3|Baseline|Total|Total of all reporting groups
376219|NCT01051778|B2|Baseline|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
376220|NCT01051778|B1|Baseline|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
376221|NCT01051778|P2|Participant Flow|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
376222|NCT01051778|P1|Participant Flow|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
376223|NCT01051778|O2|Outcome|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
376224|NCT01051778|O1|Outcome|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
376225|NCT01051778|E2|Reported Event|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
376226|NCT01051778|E1|Reported Event|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
376227|NCT01051739|B3|Baseline|Total|Total of all reporting groups
376228|NCT01051739|B2|Baseline|Group 2|normal - healthy observers with no eye pathology other than refractive error less than 6 diopters of correction.
376229|NCT01051739|B1|Baseline|Group 1|glaucoma with mean deviation from 0 to -25 dB
376230|NCT01051739|P2|Participant Flow|Group 2|normal ocular healthy controls
376231|NCT01051739|P1|Participant Flow|Group 1|glaucoma patients
376232|NCT01051739|O2|Outcome|Control|Age-matched healthy observers were tested at baseline and then every six months for 4 years
376233|NCT01051739|O1|Outcome|Glaucoma|mean deviation 0 to -25 dB
376234|NCT01051739|E2|Reported Event|Group 2|"normal~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
376235|NCT01051739|E1|Reported Event|Group 1|"glaucoma~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
376236|NCT01051570|B1|Baseline|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
376237|NCT01051570|P1|Participant Flow|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
376238|NCT01051570|O1|Outcome|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
376239|NCT01051570|E1|Reported Event|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
376241|NCT01051557|B7|Baseline|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376242|NCT01051557|B6|Baseline|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376243|NCT01051557|B5|Baseline|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376244|NCT01051557|B4|Baseline|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376245|NCT01051557|B3|Baseline|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376246|NCT01051557|B2|Baseline|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376247|NCT01051557|B1|Baseline|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376248|NCT01051557|P7|Participant Flow|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376249|NCT01051557|P6|Participant Flow|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376250|NCT01051557|P5|Participant Flow|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376251|NCT01051557|P4|Participant Flow|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376252|NCT01051557|P3|Participant Flow|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376253|NCT01051557|P2|Participant Flow|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376254|NCT01051557|P1|Participant Flow|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376255|NCT01051557|O7|Outcome|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376256|NCT01051557|O6|Outcome|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376257|NCT01051557|O5|Outcome|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376258|NCT01051557|O4|Outcome|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376259|NCT01051557|O3|Outcome|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376260|NCT01051557|O2|Outcome|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376261|NCT01051557|O1|Outcome|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376262|NCT01051557|O1|Outcome|Treatment (Temsirolimus and Perifosine)|"PHASE I: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and perifosine PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery."
376263|NCT01051557|E7|Reported Event|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376264|NCT01051557|E6|Reported Event|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376265|NCT01051557|E5|Reported Event|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376266|NCT01051557|E4|Reported Event|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376267|NCT01051557|E3|Reported Event|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376268|NCT01051557|E2|Reported Event|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376269|NCT01051557|E1|Reported Event|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
376270|NCT01051466|B3|Baseline|Total|Total of all reporting groups
376271|NCT01051466|B2|Baseline|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376272|NCT01051466|B1|Baseline|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376273|NCT01051466|P2|Participant Flow|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376274|NCT01051466|P1|Participant Flow|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376275|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376276|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom (UK) Edition (WAIS-III^UK). Healthy participants did not receive study drug.
376277|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376278|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376279|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376306|NCT01051440|B2|Baseline|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
377491|NCT01048502|B5|Baseline|Total|Total of all reporting groups
376280|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376281|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376282|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376283|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376284|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376285|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376286|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376287|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376288|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376289|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376290|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376291|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376307|NCT01051440|B1|Baseline|Placebo|Subjects received matched placebo for lisdexamfetamine.
376308|NCT01051440|P2|Participant Flow|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
376309|NCT01051440|P1|Participant Flow|Placebo|Subjects received matched placebo for lisdexamfetamine.
376292|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376293|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376294|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376295|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376296|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376297|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376298|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376299|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376300|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376301|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376302|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
376303|NCT01051466|E2|Reported Event|Healthy Participants|Healthy participants: Participants were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
376304|NCT01051466|E1|Reported Event|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD) received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose.
376305|NCT01051440|B3|Baseline|Total|Total of all reporting groups
376700|NCT01050790|E1|Reported Event|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
376310|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
376311|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
376312|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
376313|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
376314|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
376315|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
376316|NCT01051440|E2|Reported Event|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
376317|NCT01051440|E1|Reported Event|Placebo|Subjects received matched placebo for lisdexamfetamine.
376318|NCT01051323|B3|Baseline|Total|Total of all reporting groups
376319|NCT01051323|B2|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376320|NCT01051323|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376321|NCT01051323|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376322|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376323|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376324|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376325|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376326|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376327|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376328|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376329|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376330|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376331|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376332|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376333|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376334|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376335|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376336|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
377125|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
376337|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376338|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376339|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376340|NCT01051323|E2|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376341|NCT01051323|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
376342|NCT01050998|B6|Baseline|Total|Total of all reporting groups
376343|NCT01050998|B5|Baseline|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376344|NCT01050998|B4|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376345|NCT01050998|B3|Baseline|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376346|NCT01050998|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376347|NCT01050998|B1|Baseline|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376348|NCT01050998|P5|Participant Flow|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376349|NCT01050998|P4|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376350|NCT01050998|P3|Participant Flow|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376351|NCT01050998|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376352|NCT01050998|P1|Participant Flow|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376353|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376354|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376355|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376356|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376357|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376358|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376359|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376360|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376361|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376362|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376363|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376364|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376365|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
377487|NCT01048541|O2|Outcome|Standard Catheter|Standard catheter (SpediCath straight)
376366|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376367|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376368|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376369|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376370|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376371|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376372|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376373|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376374|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376375|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376376|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376377|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376378|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376379|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376380|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376381|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376382|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376383|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376384|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376385|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376386|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376387|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376388|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376389|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376390|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376391|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376392|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376393|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376394|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376395|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376959|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
376396|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376397|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376398|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376399|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376400|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376401|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376402|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376403|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376404|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376405|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376406|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376407|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376408|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376409|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376410|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376411|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376412|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376413|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376414|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376415|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376416|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376417|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376418|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376419|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376420|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376421|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376422|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376423|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376424|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376425|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376426|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376427|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376428|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376429|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376430|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376431|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376432|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376433|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376434|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376435|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376436|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376437|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376438|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376439|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376440|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376441|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376442|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376443|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376444|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376445|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376446|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376447|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376448|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376449|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376450|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376451|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376452|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376453|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376454|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376455|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376456|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376457|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376458|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376459|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376460|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376461|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376462|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376463|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376464|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376465|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376466|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376467|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376468|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376469|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376470|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376471|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376472|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376473|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376474|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376475|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376476|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376477|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376478|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376479|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376480|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376481|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376482|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376483|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376484|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376485|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376486|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376487|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376945|NCT01050153|E1|Reported Event|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376488|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376489|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376490|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376491|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376492|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376493|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376494|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376495|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376496|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376497|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376498|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376499|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376500|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376501|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376502|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376503|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376504|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376505|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376506|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376507|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376508|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376509|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376510|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376511|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376512|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376513|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376514|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376515|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376516|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376517|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376946|NCT01050062|B3|Baseline|Total|Total of all reporting groups
376947|NCT01050062|B2|Baseline|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
376518|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376519|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376520|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376521|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376522|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376523|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376524|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376525|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376526|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376527|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376528|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376529|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376530|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376531|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376532|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376533|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376534|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376535|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376536|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376537|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376538|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376539|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376540|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376541|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376542|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376543|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376544|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376545|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376546|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376547|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376948|NCT01050062|B1|Baseline|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
377546|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
376548|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376549|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376550|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376551|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376552|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376553|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376554|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376555|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376556|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376557|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376558|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376559|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376560|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376561|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376562|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376563|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376564|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376565|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376566|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376567|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376568|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376569|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376570|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376571|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376572|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376573|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376574|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376575|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376576|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376577|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376949|NCT01050062|P2|Participant Flow|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
380814|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
376578|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376579|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376580|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376581|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376582|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376583|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376584|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376585|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376586|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376587|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376588|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376589|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376590|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376591|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376592|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376593|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376594|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376595|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376596|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376597|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376598|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376599|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376600|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376601|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376602|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376603|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376604|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376605|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376606|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376607|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376950|NCT01050062|P1|Participant Flow|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
380815|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
376608|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376609|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376610|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376611|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376612|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376613|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376614|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376615|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376616|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376617|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376618|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376619|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376620|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376621|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376622|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376623|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376624|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376625|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376626|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376627|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376628|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376629|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376630|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376631|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376632|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376633|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376634|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376635|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376636|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376637|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376951|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
380816|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
376638|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376639|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376640|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376641|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376642|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376643|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376644|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376645|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376646|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376647|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376648|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376649|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376650|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376651|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376652|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376653|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376654|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376655|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376656|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376657|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376658|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376659|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376660|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376661|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376662|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376663|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376664|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376665|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376666|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376667|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376952|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
380817|NCT01037244|O4|Outcome|Placebo|Placebo tablets
376668|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376669|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376670|NCT01050998|E5|Reported Event|PLACEBO|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376671|NCT01050998|E4|Reported Event|CAM-3001 100 MG|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376672|NCT01050998|E3|Reported Event|CAM-3001 50 MG|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376673|NCT01050998|E2|Reported Event|CAM-3001 30 MG|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376674|NCT01050998|E1|Reported Event|CAM-3001 10 MG|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
376675|NCT01050946|B1|Baseline|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376676|NCT01050946|P1|Participant Flow|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376677|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376678|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376679|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376680|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376681|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376701|NCT01050764|B1|Baseline|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376702|NCT01050764|P1|Participant Flow|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376682|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376683|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant: Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376684|NCT01050946|E1|Reported Event|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
376685|NCT01050816|B1|Baseline|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
376686|NCT01050816|P1|Participant Flow|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
376687|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
376688|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
376689|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
376690|NCT01050816|E1|Reported Event|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
376691|NCT01050790|B1|Baseline|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
376692|NCT01050790|P1|Participant Flow|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
376693|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
376694|NCT01050790|O1|Outcome|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
376695|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
376696|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
376697|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
376698|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
376699|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
376703|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376704|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376705|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376706|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376707|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376708|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376709|NCT01050764|E1|Reported Event|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
376710|NCT01050673|B3|Baseline|Total|Total of all reporting groups
376711|NCT01050673|B2|Baseline|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376712|NCT01050673|B1|Baseline|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376713|NCT01050673|P2|Participant Flow|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376714|NCT01050673|P1|Participant Flow|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376715|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376716|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376717|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376718|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376719|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376720|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376721|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376722|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376723|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376724|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376725|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376726|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376727|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376728|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376729|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376730|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376731|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376732|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376733|NCT01050673|E2|Reported Event|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
376734|NCT01050673|E1|Reported Event|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
376736|NCT01050660|B2|Baseline|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376737|NCT01050660|B1|Baseline|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376738|NCT01050660|P2|Participant Flow|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376739|NCT01050660|P1|Participant Flow|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376740|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376741|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376742|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376743|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376744|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376745|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376746|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376747|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376748|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376749|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376750|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376751|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376752|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376753|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376754|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376755|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376756|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376757|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376758|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376759|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376953|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
376760|NCT01050660|E2|Reported Event|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d: Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
376761|NCT01050660|E1|Reported Event|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion: An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
376762|NCT01050647|B3|Baseline|Total|Total of all reporting groups
376763|NCT01050647|B2|Baseline|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376764|NCT01050647|B1|Baseline|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376765|NCT01050647|P2|Participant Flow|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376766|NCT01050647|P1|Participant Flow|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376767|NCT01050647|O2|Outcome|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376768|NCT01050647|O1|Outcome|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376769|NCT01050647|O2|Outcome|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376770|NCT01050647|O1|Outcome|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376771|NCT01050647|O2|Outcome|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376772|NCT01050647|O1|Outcome|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376773|NCT01050647|O2|Outcome|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376774|NCT01050647|O1|Outcome|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376775|NCT01050647|O2|Outcome|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376776|NCT01050647|O1|Outcome|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376777|NCT01050647|O2|Outcome|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376778|NCT01050647|O1|Outcome|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376779|NCT01050647|E2|Reported Event|Castor Oil Injections|"Weekly injections of Caster Oil (placebo)~Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation."
376780|NCT01050647|E1|Reported Event|17-hydroxyprogesterone Caproate|"Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation~17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate."
376781|NCT01050634|B1|Baseline|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
376782|NCT01050634|P1|Participant Flow|Aromasin (Exemestane)|The recommended dosage of exemestane was 25mg once a day.
376783|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
376784|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
376785|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
376786|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
376787|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
376788|NCT01050634|E1|Reported Event|Observational|
376789|NCT01050582|B3|Baseline|Total|Total of all reporting groups
376790|NCT01050582|B2|Baseline|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
376791|NCT01050582|B1|Baseline|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
376792|NCT01050582|P2|Participant Flow|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
376793|NCT01050582|P1|Participant Flow|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
376794|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
376795|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
376796|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
376797|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
376798|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
376799|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
376800|NCT01050582|E2|Reported Event|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
376801|NCT01050582|E1|Reported Event|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
376802|NCT01050569|B4|Baseline|Total|Total of all reporting groups
376803|NCT01050569|B3|Baseline|Nicotine Patch|21 mg nicotine patch
376804|NCT01050569|B2|Baseline|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
376805|NCT01050569|B1|Baseline|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
376806|NCT01050569|P3|Participant Flow|Nicotine Patch|Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks.
376807|NCT01050569|P2|Participant Flow|VLNC Cigarette Plus Nicotine Patch|Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks.
376808|NCT01050569|P1|Participant Flow|VLNC Cigarette|Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains <0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks.
376809|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
376810|NCT01050569|O2|Outcome|VLNC Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
376811|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
376812|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
376813|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch : 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
376814|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
376815|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
376816|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
376817|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
376818|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
376819|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
376820|NCT01050569|O1|Outcome|VLNC Cigarette|VLNC Cigarettes: Cigarette where the tobacco contains <0.1 mg nicotine yield.
376821|NCT01050569|E3|Reported Event|Nicotine Patch|21 mg nicotine patch
376822|NCT01050569|E2|Reported Event|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
376823|NCT01050569|E1|Reported Event|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
376824|NCT01050543|B3|Baseline|Total|Total of all reporting groups
376825|NCT01050543|B2|Baseline|Neostigmine|neostigmine 50 mcg/kg
376826|NCT01050543|B1|Baseline|Sugammadex|sugammadex 2 mg/kg
376827|NCT01050543|P2|Participant Flow|Neostigmine|neostigmine 50 mcg/kg
376828|NCT01050543|P1|Participant Flow|Sugammadex|sugammadex 2 mg/kg
376829|NCT01050543|O2|Outcome|Neostigmine|neostigmine 50 mcg/kg
376830|NCT01050543|O1|Outcome|Sugammadex|sugammadex 2 mg/kg
376831|NCT01050543|E2|Reported Event|Neostigmine|neostigmine 50 mcg/kg
376832|NCT01050543|E1|Reported Event|Sugammadex|sugammadex 2 mg/kg
376833|NCT01050530|B3|Baseline|Total|Total of all reporting groups
376834|NCT01050530|B2|Baseline|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
376835|NCT01050530|B1|Baseline|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
376836|NCT01050530|P2|Participant Flow|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
376837|NCT01050530|P1|Participant Flow|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
376838|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
376839|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
376840|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
376841|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
376842|NCT01050530|E2|Reported Event|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
376843|NCT01050530|E1|Reported Event|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
376844|NCT01050257|B4|Baseline|Total|Total of all reporting groups
376954|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
376845|NCT01050257|B3|Baseline|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376846|NCT01050257|B2|Baseline|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376847|NCT01050257|B1|Baseline|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376848|NCT01050257|P3|Participant Flow|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376849|NCT01050257|P2|Participant Flow|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376850|NCT01050257|P1|Participant Flow|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376851|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376852|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376853|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376854|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376855|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376856|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376857|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376858|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376859|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376860|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376955|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
377488|NCT01048541|O1|Outcome|Test Catheter|Test catheter (SpeediCath Compact Male)
376861|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376862|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376863|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376864|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376865|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376866|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376867|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376868|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376869|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376870|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376871|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376872|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376873|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376874|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376875|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376876|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
377489|NCT01048541|E2|Reported Event|Standard Catheter|Standard catheter (SpediCath straight)
376877|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376878|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376879|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376880|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376881|NCT01050257|E3|Reported Event|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
376882|NCT01050257|E2|Reported Event|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376883|NCT01050257|E1|Reported Event|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
376884|NCT01050218|B1|Baseline|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
376885|NCT01050218|P1|Participant Flow|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
376886|NCT01050218|O1|Outcome|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
376887|NCT01050218|E1|Reported Event|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
376888|NCT01050205|B3|Baseline|Total|Total of all reporting groups
376889|NCT01050205|B2|Baseline|Delayed Intervention|"At enrollment, participants are randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376890|NCT01050205|B1|Baseline|Current Intervention|"At enrollment, participants are randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376891|NCT01050205|P2|Participant Flow|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376956|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
376957|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
377490|NCT01048541|E1|Reported Event|Test Catheter|Test catheter (SpeediCath Compact Male)
376892|NCT01050205|P1|Participant Flow|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376893|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376894|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376895|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376896|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376897|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376898|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376899|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376900|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376901|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376902|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376903|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376904|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376905|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376906|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376907|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376908|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376909|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376910|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376911|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376912|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376913|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376914|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376915|NCT01050205|O2|Outcome|Delayed Intervention|"At enrollment, participants randomly assigned to Delayed intervention will receive the intervention in 6 months. The intervention is identical to that received by participants assigned to the Current Intervention Arm and is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376916|NCT01050205|O1|Outcome|Current Intervention|"At enrollment, participants randomly assigned to Current Intervention will receive the intervention immediately.The intervention is based on the Diabetes Prevention Program's successful lifestyle intervention with goals of achieving a 7% weight loss, and progressively increasing physical activity to 150 minutes per week of moderately intense physical activity.Participants will choose one of the following interventions:~GLB-GROUP: Individuals who choose group delivery will attend weekly in-person group meetings for 12 weeks, then transition to bi-weekly and monthly meetings. GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. Participants in GLB-DVD will also be invited to attend monthly group meetings and will receive weekly telephone calls from a trained coach."
376917|NCT01050205|E2|Reported Event|Delayed Intervention|No unexpected or unanticipated adverse events occurred in the Delayed Intervention group.
376918|NCT01050205|E1|Reported Event|Current Intervention|No unexpected or unanticipated adverse events occurred in the Current Intervention group.
376919|NCT01050153|B3|Baseline|Total|Total of all reporting groups
376920|NCT01050153|B2|Baseline|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376921|NCT01050153|B1|Baseline|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376922|NCT01050153|P2|Participant Flow|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376923|NCT01050153|P1|Participant Flow|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376924|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376925|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376926|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376927|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376928|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376929|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376930|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376931|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376932|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376933|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376934|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376935|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376936|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376937|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376938|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376939|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376940|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376941|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376942|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376943|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
376944|NCT01050153|E2|Reported Event|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
376958|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
376960|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
376961|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
376962|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
376963|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
376964|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
376965|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
376966|NCT01050062|E3|Reported Event|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
376967|NCT01050062|E2|Reported Event|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
376968|NCT01050062|E1|Reported Event|Combination Tablet Ap|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
376969|NCT01049984|B3|Baseline|Total|Total of all reporting groups
376970|NCT01049984|B2|Baseline|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376971|NCT01049984|B1|Baseline|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376972|NCT01049984|P2|Participant Flow|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376973|NCT01049984|P1|Participant Flow|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376974|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376975|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376976|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376977|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376978|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376979|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376980|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376981|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376982|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376983|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376984|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376985|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376986|NCT01049984|E2|Reported Event|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
376987|NCT01049984|E1|Reported Event|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
376988|NCT01049945|B3|Baseline|Total|Total of all reporting groups
376989|NCT01049945|B2|Baseline|Maximum Tolerated Dose, Dose Level 4|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
376990|NCT01049945|B1|Baseline|Phase I|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
376991|NCT01049945|P6|Participant Flow|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
376992|NCT01049945|P5|Participant Flow|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
376993|NCT01049945|P4|Participant Flow|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
376994|NCT01049945|P3|Participant Flow|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
376995|NCT01049945|P2|Participant Flow|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
376996|NCT01049945|P1|Participant Flow|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
376997|NCT01049945|O1|Outcome|Maximum Tolerated Dose, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
376998|NCT01049945|O5|Outcome|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377389|NCT01048788|B2|Baseline|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
376999|NCT01049945|O4|Outcome|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377000|NCT01049945|O3|Outcome|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377001|NCT01049945|O2|Outcome|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377002|NCT01049945|O1|Outcome|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377003|NCT01049945|E6|Reported Event|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377004|NCT01049945|E5|Reported Event|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377005|NCT01049945|E4|Reported Event|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377006|NCT01049945|E3|Reported Event|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377007|NCT01049945|E2|Reported Event|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377008|NCT01049945|E1|Reported Event|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
377009|NCT01049802|B3|Baseline|Total|Total of all reporting groups
377010|NCT01049802|B2|Baseline|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377011|NCT01049802|B1|Baseline|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377012|NCT01049802|P2|Participant Flow|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377013|NCT01049802|P1|Participant Flow|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377014|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377015|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377016|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377017|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377018|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377019|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377020|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377051|NCT01049503|P4|Participant Flow|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377021|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377022|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377023|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377024|NCT01049802|E2|Reported Event|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377025|NCT01049802|E1|Reported Event|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
377026|NCT01049776|B1|Baseline|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
377027|NCT01049776|P1|Participant Flow|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
377028|NCT01049776|O1|Outcome|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
377029|NCT01049776|E1|Reported Event|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
377030|NCT01049581|B3|Baseline|Total|Total of all reporting groups
377031|NCT01049581|B2|Baseline|Conventional Therapy Group|The participants were classified into the control (conventional therapy) group according to preference. The children included in the control group continued with their original rehabilitation programs.
377032|NCT01049581|B1|Baseline|Pediatric Aquatic Therapy Group|The participants were classified into two groups the pediatric aquatic therapy group according the their preference. The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs.
377033|NCT01049581|P2|Participant Flow|Conventional Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the conventional therapy according to preference
377034|NCT01049581|P1|Participant Flow|Pediatric Aquatic Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the pediatric aquatic therapy according to preference
377035|NCT01049581|O2|Outcome|Conventional Therapy|Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate conventional therapy according preference
377036|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate pediatric aquatic therapy according preference
377037|NCT01049581|O2|Outcome|Conventional Therapy|14 children diagnosed as spastic type cerebral palsy participate conventional therapy and 13 children finish the study,each of them fulfill the the questionnaire before and after the intervention
377038|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic type cerebral palsy participate pediatric auqatic therapy and 11 children finish the study,each of them fulfill the the questionnaire before and after the intervention
377039|NCT01049581|O2|Outcome|Conventional Therapy|Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
377040|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study
377041|NCT01049581|E1|Reported Event|Effects of Pediatric Aquatic Therapy on Motor Performance|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I–IV,
377042|NCT01049503|B7|Baseline|Total|Total of all reporting groups
377043|NCT01049503|B6|Baseline|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377044|NCT01049503|B5|Baseline|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377045|NCT01049503|B4|Baseline|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377046|NCT01049503|B3|Baseline|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377047|NCT01049503|B2|Baseline|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377048|NCT01049503|B1|Baseline|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377049|NCT01049503|P6|Participant Flow|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377050|NCT01049503|P5|Participant Flow|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377052|NCT01049503|P3|Participant Flow|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377053|NCT01049503|P2|Participant Flow|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377054|NCT01049503|P1|Participant Flow|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377055|NCT01049503|O3|Outcome|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377056|NCT01049503|O2|Outcome|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377057|NCT01049503|O1|Outcome|Caries-inactive 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377058|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377059|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377060|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377061|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377062|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377063|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377064|NCT01049503|O3|Outcome|1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
377065|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
377066|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
377067|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377068|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377069|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377070|NCT01049503|O3|Outcome|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377071|NCT01049503|O2|Outcome|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377072|NCT01049503|O1|Outcome|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377073|NCT01049503|O3|Outcome|1100 ppmF , pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
377074|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
377075|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
377076|NCT01049503|E6|Reported Event|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377077|NCT01049503|E5|Reported Event|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377078|NCT01049503|E4|Reported Event|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
377079|NCT01049503|E3|Reported Event|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377080|NCT01049503|E2|Reported Event|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377081|NCT01049503|E1|Reported Event|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
377082|NCT01049412|B3|Baseline|Total|Total of all reporting groups
377083|NCT01049412|B2|Baseline|Glargine/LY2605541|Participants took Glargine in Period I and LY2605541 in Period II
377084|NCT01049412|B1|Baseline|LY2605541/Glargine|Participants took LY2605541 in Period I and Glargine in Period II
377085|NCT01049412|P2|Participant Flow|Glargine/LY2605541|Participants took Glargine in Period I and LY2605541 in Period II
377086|NCT01049412|P1|Participant Flow|LY2605541/Glargine|Participants took LY2605541 in Period I and Glargine in Period II
377474|NCT01048593|B1|Baseline|Dose 1|114ug dose group
377087|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377088|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377089|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377090|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377091|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377092|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377093|NCT01049412|O2|Outcome|Glargine/LY2605541|Participants took Glargine in Period I and LY2605541 in Period II
377094|NCT01049412|O1|Outcome|LY2605541/Glargine|Participants took LY2605541 in Period I and Glargine in Period II
377095|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377096|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377097|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377098|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377099|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377100|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377101|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377102|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377103|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377104|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377105|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377106|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377107|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377108|NCT01049412|O2|Outcome|Glargine|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377109|NCT01049412|O1|Outcome|LY2605541|Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods
377110|NCT01049412|E2|Reported Event|Glargine|Participants took Glargine administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
377111|NCT01049412|E1|Reported Event|LY2605541|Participants took LY2605541 administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks
377112|NCT01049373|B3|Baseline|Total|Total of all reporting groups
377113|NCT01049373|B2|Baseline|Placebo Solution|10 drops t.i.d. for 15 weeks
377114|NCT01049373|B1|Baseline|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377115|NCT01049373|P2|Participant Flow|Placebo Solution|10 drops t.i.d. for 15 weeks
377116|NCT01049373|P1|Participant Flow|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377117|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
377118|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377119|NCT01049373|O2|Outcome|PLACEBO Solution|10 drops t.i.d. for 15 weeks
377120|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377121|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
377122|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377123|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
377124|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377126|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377127|NCT01049373|E2|Reported Event|Placebo Solution|10 drops t.i.d. for 15 weeks
377128|NCT01049373|E1|Reported Event|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
377129|NCT01049360|B1|Baseline|Overall Population|Safety population defined as all randomized patients who took at least one dose of double-blind investigational product
377130|NCT01049360|P20|Participant Flow|Sequence 20|Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12
377131|NCT01049360|P19|Participant Flow|Sequence 19|Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6
377132|NCT01049360|P18|Participant Flow|Sequence 18|Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo
377133|NCT01049360|P17|Participant Flow|Sequence 17|Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol
377134|NCT01049360|P16|Participant Flow|Sequence 16|Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium
377135|NCT01049360|P15|Participant Flow|Sequence 15|Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol
377136|NCT01049360|P14|Participant Flow|Sequence 14|Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium
377137|NCT01049360|P13|Participant Flow|Sequence 13|Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12
377138|NCT01049360|P12|Participant Flow|Sequence 12|Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6
377139|NCT01049360|P11|Participant Flow|Sequence 11|Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo
377140|NCT01049360|P10|Participant Flow|Sequence 10|Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6
377141|NCT01049360|P9|Participant Flow|Sequence 9|Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo
377142|NCT01049360|P8|Participant Flow|Sequence 8|Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol
377143|NCT01049360|P7|Participant Flow|Sequence 7|Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium
377144|NCT01049360|P6|Participant Flow|Sequence 6|Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12
377145|NCT01049360|P5|Participant Flow|Sequence 5|Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium
377146|NCT01049360|P4|Participant Flow|Sequence 4|Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12
377147|NCT01049360|P3|Participant Flow|Sequence 3|Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6
377148|NCT01049360|P2|Participant Flow|Sequence 2|Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo
377149|NCT01049360|P1|Participant Flow|Sequence 1|Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol
377150|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
377151|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
377152|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
377153|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
377154|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
377155|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
377156|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
377157|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
377158|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
377159|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
377160|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
377161|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
377162|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
377163|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
377164|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
377165|NCT01049360|E5|Reported Event|Placebo|Placebo twice-daily
377166|NCT01049360|E4|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
377167|NCT01049360|E3|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
377168|NCT01049360|E2|Reported Event|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
377169|NCT01049360|E1|Reported Event|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
377170|NCT01049334|B3|Baseline|Total|Total of all reporting groups
377171|NCT01049334|B2|Baseline|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377172|NCT01049334|B1|Baseline|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377173|NCT01049334|P2|Participant Flow|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377174|NCT01049334|P1|Participant Flow|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377175|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377176|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377177|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377178|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377179|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377180|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377181|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377182|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377183|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377184|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377185|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377186|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377187|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377188|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377189|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377190|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377191|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377192|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377193|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377194|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377195|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377196|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377197|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377198|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377199|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377200|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377201|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377202|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377203|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377204|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377205|NCT01049334|O2|Outcome|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377206|NCT01049334|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377207|NCT01049334|E2|Reported Event|Placebo Lozenge|Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377208|NCT01049334|E1|Reported Event|Flurbiprofen 8.75 mg Lozenge|Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
377209|NCT01049308|B1|Baseline|Group 1|veteran population with documented heart failure
377210|NCT01049308|P1|Participant Flow|Heart Failure|veteran population with documented heart failure
377211|NCT01049308|O3|Outcome|Severe CI|veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
377212|NCT01049308|O2|Outcome|Mild CI|veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
377213|NCT01049308|O1|Outcome|No CI|veteran population with documented heart failure with no cognitive impairment on SLUMS screening test who finished 30-day pill counts
377214|NCT01049308|O1|Outcome|Heart Failure|veteran population with documented heart failure
377215|NCT01049308|E1|Reported Event|Group 1|veteran population with documented heart failure
377216|NCT01049243|B1|Baseline|Single Group|
377217|NCT01049243|P1|Participant Flow|Vanos|Single group; 0.1% Cream, One Application, Twice Daily, 14 Days
377475|NCT01048593|P3|Participant Flow|Dose 3|684ug dose group
377218|NCT01049243|O1|Outcome|Fluocinonide Cream 0.1%|"Fluocinonide Cream 0.1% open label~Fluocinonide Cream 0.1%: 0.1% Cream, One Application, Twice Daily, 14 Days"
377219|NCT01049243|O1|Outcome|Single Group|
377220|NCT01049243|E1|Reported Event|Single Group|
377221|NCT01049217|B3|Baseline|Total|Total of all reporting groups
377222|NCT01049217|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377223|NCT01049217|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377224|NCT01049217|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377225|NCT01049217|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377226|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377227|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377228|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377229|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377230|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377316|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
377317|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
377318|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
377476|NCT01048593|P2|Participant Flow|Dose 2|513ug dose group
377231|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377232|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377233|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377234|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377235|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377236|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377237|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377238|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377239|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377240|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377319|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
377241|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377242|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377243|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377244|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377245|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377246|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377247|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377248|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377249|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377250|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377320|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
377477|NCT01048593|P1|Participant Flow|Dose 1|114ug dose group
377251|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377252|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377253|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377254|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377255|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377256|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377257|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377258|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377259|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377260|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377321|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
377322|NCT01048944|E4|Reported Event|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
377261|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377262|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377263|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377264|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377265|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377266|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377267|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377268|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377269|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377270|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377359|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377271|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377272|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377273|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377274|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377275|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377276|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377277|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377278|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377279|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377280|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377360|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377281|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377282|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377283|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377284|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377285|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377286|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377287|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377288|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377289|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377290|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377361|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377291|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377292|NCT01049217|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377293|NCT01049217|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
377294|NCT01049009|B3|Baseline|Total|Total of all reporting groups
377295|NCT01049009|B2|Baseline|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
377296|NCT01049009|B1|Baseline|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
377297|NCT01049009|P2|Participant Flow|Metoprolol XL/Nebivolol|Subjects are randomized to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after cross over.
377298|NCT01049009|P1|Participant Flow|Nebivolol/Metoprolol XL|Subjects are randomized to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after cross over.
377299|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
377300|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
377301|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
377302|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
377303|NCT01049009|E2|Reported Event|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
377304|NCT01049009|E1|Reported Event|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
377305|NCT01048944|B5|Baseline|Total|Total of all reporting groups
377306|NCT01048944|B4|Baseline|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
377307|NCT01048944|B3|Baseline|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
377308|NCT01048944|B2|Baseline|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
377309|NCT01048944|B1|Baseline|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
377310|NCT01048944|P4|Participant Flow|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
377311|NCT01048944|P3|Participant Flow|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
377312|NCT01048944|P2|Participant Flow|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
377313|NCT01048944|P1|Participant Flow|Bupropion Sustained Release (SR)|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
377314|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
377315|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
377478|NCT01048593|O3|Outcome|Dose 3|684ug dose group
377323|NCT01048944|E3|Reported Event|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56 days at 2x/day, then 3 days at 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
377324|NCT01048944|E2|Reported Event|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
377325|NCT01048944|E1|Reported Event|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down."
377326|NCT01048879|B4|Baseline|Total|Total of all reporting groups
377327|NCT01048879|B3|Baseline|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
377328|NCT01048879|B2|Baseline|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
377329|NCT01048879|B1|Baseline|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
377330|NCT01048879|P3|Participant Flow|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
377331|NCT01048879|P2|Participant Flow|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
377332|NCT01048879|P1|Participant Flow|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
377333|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
377334|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
377335|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
377336|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
377337|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
377338|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
377339|NCT01048879|E3|Reported Event|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
377340|NCT01048879|E2|Reported Event|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
377341|NCT01048879|E1|Reported Event|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
377342|NCT01048866|B3|Baseline|Total|Total of all reporting groups
377343|NCT01048866|B2|Baseline|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377344|NCT01048866|B1|Baseline|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377345|NCT01048866|P2|Participant Flow|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377346|NCT01048866|P1|Participant Flow|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377347|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377348|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377349|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377350|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377351|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377352|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377353|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377354|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377355|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377356|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377357|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377358|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377479|NCT01048593|O2|Outcome|Dose 2|513ug dose group
377362|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377363|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377364|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377365|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377366|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377367|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377368|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377369|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377370|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377371|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377372|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377373|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377374|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377375|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377376|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377377|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377378|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377379|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377380|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377381|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377382|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377383|NCT01048866|O2|Outcome|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377384|NCT01048866|O1|Outcome|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377385|NCT01048866|E2|Reported Event|Placebo Lozenge|Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377386|NCT01048866|E1|Reported Event|Flurbiprofen 8.75 mg Lozenge|Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
377387|NCT01048788|B4|Baseline|Total|Total of all reporting groups
377388|NCT01048788|B3|Baseline|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
377480|NCT01048593|O1|Outcome|Dose 1|114ug dose group
377390|NCT01048788|B1|Baseline|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
377391|NCT01048788|P3|Participant Flow|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
377392|NCT01048788|P2|Participant Flow|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
377393|NCT01048788|P1|Participant Flow|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
377394|NCT01048788|O3|Outcome|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
377395|NCT01048788|O2|Outcome|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
377396|NCT01048788|O1|Outcome|Discontitued/Terminated Before Day 8|Subjects who discontinued treatment before Day 7 or teiminated by meeting the criteria on Day 7
377397|NCT01048788|E3|Reported Event|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
377398|NCT01048788|E2|Reported Event|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
377399|NCT01048788|E1|Reported Event|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
377400|NCT01048723|B1|Baseline|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
377401|NCT01048723|P1|Participant Flow|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
377402|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
377403|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
377404|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
377405|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
377406|NCT01048723|E1|Reported Event|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
377407|NCT01048697|B1|Baseline|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
377408|NCT01048697|P1|Participant Flow|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
377409|NCT01048697|O1|Outcome|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
377410|NCT01048697|E1|Reported Event|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
377411|NCT01048671|B4|Baseline|Total|Total of all reporting groups
377412|NCT01048671|B3|Baseline|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
377413|NCT01048671|B2|Baseline|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
377414|NCT01048671|B1|Baseline|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377481|NCT01048593|E3|Reported Event|Dose 3|684ug dose group
377482|NCT01048593|E2|Reported Event|Dose 2|513ug dose group
377483|NCT01048593|E1|Reported Event|Dose 1|114ug dose group
377415|NCT01048671|P3|Participant Flow|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377416|NCT01048671|P2|Participant Flow|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377417|NCT01048671|P1|Participant Flow|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377418|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377419|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377420|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377421|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377422|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377423|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377424|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377425|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377426|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377427|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377428|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377429|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377430|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377431|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377432|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377433|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377434|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377435|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377436|NCT01048671|E1|Reported Event|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
377437|NCT01048658|B3|Baseline|Total|Total of all reporting groups
377438|NCT01048658|B2|Baseline|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377484|NCT01048541|B1|Baseline|Entire Study|Includes groups randomized to standard catheter first and test catheter first
377439|NCT01048658|B1|Baseline|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377440|NCT01048658|P2|Participant Flow|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377441|NCT01048658|P1|Participant Flow|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377442|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377443|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377444|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377445|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377446|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377447|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377448|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377449|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377450|NCT01048658|O2|Outcome|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377451|NCT01048658|O1|Outcome|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377452|NCT01048658|E2|Reported Event|No Sevoflurane|"Subject receives standard of care drug regimens for anesthesia with this procedure.~No Sevoflurane: Subject only standard of care drug regimens for anesthesia with this procedure."
377453|NCT01048658|E1|Reported Event|Sevoflurane|"Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.~Sevoflurane: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure."
377454|NCT01048606|B5|Baseline|Total|Total of all reporting groups
377455|NCT01048606|B4|Baseline|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
377456|NCT01048606|B3|Baseline|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377457|NCT01048606|B2|Baseline|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
377458|NCT01048606|B1|Baseline|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377459|NCT01048606|P4|Participant Flow|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
377485|NCT01048541|P2|Participant Flow|BA: First Standard Catheter Then Test Catheter|Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
377486|NCT01048541|P1|Participant Flow|AB: First Test Catheter Then Standard Catheter|Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period
377460|NCT01048606|P3|Participant Flow|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377461|NCT01048606|P2|Participant Flow|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
377462|NCT01048606|P1|Participant Flow|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377463|NCT01048606|O4|Outcome|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
377464|NCT01048606|O3|Outcome|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377465|NCT01048606|O2|Outcome|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
377466|NCT01048606|O1|Outcome|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377467|NCT01048606|E4|Reported Event|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
377468|NCT01048606|E3|Reported Event|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377469|NCT01048606|E2|Reported Event|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
377470|NCT01048606|E1|Reported Event|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
377471|NCT01048593|B4|Baseline|Total|Total of all reporting groups
377472|NCT01048593|B3|Baseline|Dose 3|684ug dose group
377473|NCT01048593|B2|Baseline|Dose 2|513ug dose group
377492|NCT01048502|B4|Baseline|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377493|NCT01048502|B3|Baseline|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377494|NCT01048502|B2|Baseline|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
377495|NCT01048502|B1|Baseline|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
377496|NCT01048502|P4|Participant Flow|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377497|NCT01048502|P3|Participant Flow|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377498|NCT01048502|P2|Participant Flow|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
377499|NCT01048502|P1|Participant Flow|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
377500|NCT01048502|O2|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
377501|NCT01048502|O1|Outcome|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
377502|NCT01048502|O3|Outcome|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377503|NCT01048502|O2|Outcome|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377504|NCT01048502|O1|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
377505|NCT01048502|E4|Reported Event|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377506|NCT01048502|E3|Reported Event|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
377507|NCT01048502|E2|Reported Event|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
377508|NCT01048502|E1|Reported Event|Tricor (145 mg/Day)|"Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
377509|NCT01048424|B3|Baseline|Total|Total of all reporting groups
377510|NCT01048424|B2|Baseline|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377511|NCT01048424|B1|Baseline|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377512|NCT01048424|P2|Participant Flow|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377513|NCT01048424|P1|Participant Flow|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377514|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377515|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377516|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377517|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377518|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377519|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377520|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377521|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377522|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377523|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377524|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377525|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377526|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377527|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377528|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377529|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377530|NCT01048424|O2|Outcome|Control|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377531|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377532|NCT01048424|E2|Reported Event|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377533|NCT01048424|E1|Reported Event|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
377534|NCT01048333|B1|Baseline|Entire Study Population|Includes all 3 arms : Formoterol, Salmeterol and Placebo.
377535|NCT01048333|P6|Participant Flow|Placebo, Then Salmeterol, Then Formoterol|Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
377536|NCT01048333|P5|Participant Flow|Salmeterol, Then Formoterol, Then Placebo|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
377537|NCT01048333|P4|Participant Flow|Formoterol, Then Placebo, Then Salmeterol|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
377538|NCT01048333|P3|Participant Flow|Placebo, Then Formoterol, Then Salmeterol|Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
377539|NCT01048333|P2|Participant Flow|Salmeterol, Then Palcebo, Then Formoterol|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
377540|NCT01048333|P1|Participant Flow|Formoterol, Then Salmeterol, Then Placebo|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
377541|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
377542|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
377543|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
377544|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
377545|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
377547|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
377548|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
377549|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
377550|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
377551|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
377552|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
377553|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
377554|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
377555|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
377556|NCT01048333|E3|Reported Event|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
377557|NCT01048333|E2|Reported Event|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
377558|NCT01048333|E1|Reported Event|Formoterol|Formoterol Turbuhaler 9 mcg
377559|NCT01048242|B3|Baseline|Total|Total of all reporting groups
377560|NCT01048242|B2|Baseline|Sugar Pill|
377561|NCT01048242|B1|Baseline|Ramelteon|Ramelteon 8 mg oral before bedtime
377562|NCT01048242|P2|Participant Flow|Sugar Pill|
377563|NCT01048242|P1|Participant Flow|Ramelteon|Ramelteon 8 mg oral before bedtime
377564|NCT01048242|O2|Outcome|Sugar Pill|
377565|NCT01048242|O1|Outcome|Ramelteon|Ramelteon 8 mg oral before bedtime
377566|NCT01048242|E2|Reported Event|Sugar Pill|
377567|NCT01048242|E1|Reported Event|Ramelteon|Ramelteon 8 mg oral before bedtime
377568|NCT01048125|B3|Baseline|Total|Total of all reporting groups
377569|NCT01048125|B2|Baseline|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
377570|NCT01048125|B1|Baseline|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
377571|NCT01048125|P2|Participant Flow|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
377572|NCT01048125|P1|Participant Flow|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
377573|NCT01048125|O2|Outcome|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
377574|NCT01048125|O1|Outcome|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
377575|NCT01048125|E2|Reported Event|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
377576|NCT01048125|E1|Reported Event|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
377577|NCT01048099|B1|Baseline|Patients Treated|Patients who received study treatment
377578|NCT01048099|P1|Participant Flow|All Patients|
377579|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
377580|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
377581|NCT01048099|O1|Outcome|All Patients|
377582|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
377583|NCT01048099|O1|Outcome|All Patients Evaluated by PRO Onc Assay|
377584|NCT01048099|E1|Reported Event|All Treated Patients|Includes all patients with HER2 overexpression/activation (as identified by the PRO Onc Assay) who received study treatment
377585|NCT01047839|B4|Baseline|Total|Total of all reporting groups
377586|NCT01047839|B3|Baseline|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
377587|NCT01047839|B2|Baseline|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
377588|NCT01047839|B1|Baseline|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
377589|NCT01047839|P3|Participant Flow|>=12 to <18 Years|IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
377590|NCT01047839|P2|Participant Flow|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
377591|NCT01047839|P1|Participant Flow|>=2 Months to <3 Years|IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
377592|NCT01047839|O3|Outcome|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
377593|NCT01047839|O2|Outcome|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
377594|NCT01047839|O1|Outcome|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
377595|NCT01047839|E3|Reported Event|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
377596|NCT01047839|E2|Reported Event|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
377597|NCT01047839|E1|Reported Event|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
377598|NCT01047709|B1|Baseline|All Study Participants|All study participants.
377599|NCT01047709|P2|Participant Flow|Control Night First, Then Positional Therapy Night|Position ad lib for the first night, then one night of avoidance of supine positioning.
377600|NCT01047709|P1|Participant Flow|Positional Therapy Night First, Then Control Night|Avoidance of supine positioning on the first night, followed by a second night of positioning ad lib.
377601|NCT01047709|O2|Outcome|Control Night|Position ad lib
377602|NCT01047709|O1|Outcome|Positional Therapy Night|Avoidance of supine positioning.
377603|NCT01047709|E2|Reported Event|Control Night|Position ad lib
377604|NCT01047709|E1|Reported Event|Positional Therapy Night|Avoidance of supine positioning.
377605|NCT01047553|B3|Baseline|Total|Total of all reporting groups
377606|NCT01047553|B2|Baseline|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377607|NCT01047553|B1|Baseline|Formoterol|Formoterol 9 μg twice daily
377608|NCT01047553|P2|Participant Flow|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377609|NCT01047553|P1|Participant Flow|Formoterol|Formoterol 9 μg twice daily
377610|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377611|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377612|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377613|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377614|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377615|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377616|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377617|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377618|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377619|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377620|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377621|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377622|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377623|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377624|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377625|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377626|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377627|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377628|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377629|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377630|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377631|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377632|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377633|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377634|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377635|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377636|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377637|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377638|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377639|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377640|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377641|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377642|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377643|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377644|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377645|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377646|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377647|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377648|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377649|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377650|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377651|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377652|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377653|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377654|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377655|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377656|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377657|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377658|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377659|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377660|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377661|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377662|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377663|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377664|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377665|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377666|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377667|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377668|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377669|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377670|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377671|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377672|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377673|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377674|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377675|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377676|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377677|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377678|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377679|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377680|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377681|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377682|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377683|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377684|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377685|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377686|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377687|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
377688|NCT01047553|E2|Reported Event|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
377689|NCT01047553|E1|Reported Event|Formoterol|Formoterol 9 μg twice daily
377690|NCT01047527|B4|Baseline|Total|Total of all reporting groups
377691|NCT01047527|B3|Baseline|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377692|NCT01047527|B2|Baseline|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377693|NCT01047527|B1|Baseline|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377694|NCT01047527|P3|Participant Flow|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377695|NCT01047527|P2|Participant Flow|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377696|NCT01047527|P1|Participant Flow|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377697|NCT01047527|O2|Outcome|Extended + Maintenance|
377698|NCT01047527|O1|Outcome|Standard|
377699|NCT01047527|O2|Outcome|Maintenance|Participants on 52 weeks of therapy
377700|NCT01047527|O1|Outcome|Standard + Extended|participants on standard or extended therapy
377701|NCT01047527|E3|Reported Event|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377702|NCT01047527|E2|Reported Event|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377703|NCT01047527|E1|Reported Event|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
377704|NCT01047475|B3|Baseline|Total|Total of all reporting groups
377705|NCT01047475|B2|Baseline|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
377706|NCT01047475|B1|Baseline|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
377707|NCT01047475|P2|Participant Flow|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
377708|NCT01047475|P1|Participant Flow|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
377709|NCT01047475|O2|Outcome|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
377710|NCT01047475|O1|Outcome|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
377711|NCT01047475|E2|Reported Event|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
377712|NCT01047475|E1|Reported Event|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
377713|NCT01047436|B3|Baseline|Total|Total of all reporting groups
377714|NCT01047436|B2|Baseline|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
380818|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
377715|NCT01047436|B1|Baseline|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377716|NCT01047436|P2|Participant Flow|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377717|NCT01047436|P1|Participant Flow|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377718|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377719|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377720|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377721|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377722|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377723|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377724|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377725|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377726|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377727|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377728|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377729|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377730|NCT01047436|E2|Reported Event|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
377731|NCT01047436|E1|Reported Event|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
377732|NCT01047358|B1|Baseline|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
377733|NCT01047358|P1|Participant Flow|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
377734|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
377735|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
377736|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
377737|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
377738|NCT01047358|E1|Reported Event|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
377739|NCT01047345|B3|Baseline|Total|Total of all reporting groups
377740|NCT01047345|B2|Baseline|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377741|NCT01047345|B1|Baseline|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377742|NCT01047345|P3|Participant Flow|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
377743|NCT01047345|P2|Participant Flow|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377744|NCT01047345|P1|Participant Flow|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377745|NCT01047345|O1|Outcome|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
377746|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377747|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377748|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377749|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377750|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377751|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377752|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377753|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377754|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377755|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377756|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377757|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377758|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377759|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377760|NCT01047345|E3|Reported Event|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
377761|NCT01047345|E2|Reported Event|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
377762|NCT01047345|E1|Reported Event|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
377763|NCT01047332|B3|Baseline|Total|Total of all reporting groups
377764|NCT01047332|B2|Baseline|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
377765|NCT01047332|B1|Baseline|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
377766|NCT01047332|P2|Participant Flow|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
377767|NCT01047332|P1|Participant Flow|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
377768|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
377769|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
377770|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
377771|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
377772|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
377773|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
377774|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
377775|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
377776|NCT01047332|E2|Reported Event|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
377777|NCT01047332|E1|Reported Event|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
377778|NCT01047306|B3|Baseline|Total|Total of all reporting groups
377779|NCT01047306|B2|Baseline|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
378917|NCT01043185|E5|Reported Event|Placebo|a morning and an evening dose of placebo
377780|NCT01047306|B1|Baseline|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377781|NCT01047306|P2|Participant Flow|Children ≥ 6 Years Old|Children ≥ 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
377782|NCT01047306|P1|Participant Flow|Children < 6 Years Old|Children ≥1 to < 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
377783|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377784|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377785|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377786|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377787|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377788|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377789|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377790|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377791|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377792|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377793|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377794|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377795|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377796|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377797|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377798|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377799|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377800|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377801|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377802|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377803|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377804|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377805|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377806|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377807|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377808|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377809|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377810|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377811|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377812|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377813|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377814|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377815|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377816|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377817|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377818|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377819|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377820|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377821|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377822|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377823|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377824|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377825|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377826|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377827|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377828|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377829|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377830|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377831|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377832|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377833|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377834|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377835|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377836|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377837|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377838|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377839|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377840|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377841|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377842|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377843|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377844|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377845|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377846|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377847|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377848|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377849|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377850|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377851|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377852|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377853|NCT01047306|E2|Reported Event|Children ≥ 6 Years|Patients ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377854|NCT01047306|E1|Reported Event|Children < 6 Years|Patients ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
377855|NCT01047293|B1|Baseline|All Patients|
377856|NCT01047293|P4|Participant Flow|ARM 4 10mg RAD001 QD - Phase II|Patients received 10 mg RAD001 with FOLFOX and bevacizumab. - Patient in the Dose Expansion Cohort not Dose Escalation
377857|NCT01047293|P3|Participant Flow|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
377858|NCT01047293|P2|Participant Flow|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
377859|NCT01047293|P1|Participant Flow|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
378918|NCT01043185|E4|Reported Event|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
377860|NCT01047293|O3|Outcome|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
377861|NCT01047293|O2|Outcome|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
377862|NCT01047293|O1|Outcome|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
377863|NCT01047293|O1|Outcome|All Patients|
377864|NCT01047293|E1|Reported Event|All Patients|All participants enrolled.
377865|NCT01047241|B1|Baseline|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
377866|NCT01047241|P1|Participant Flow|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
377867|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
377868|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
377869|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
377870|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing sufentanil/ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
377871|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
377872|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
377873|NCT01047241|E1|Reported Event|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
377874|NCT01047189|B3|Baseline|Total|Total of all reporting groups
377875|NCT01047189|B2|Baseline|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
377876|NCT01047189|B1|Baseline|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
377877|NCT01047189|P2|Participant Flow|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
377878|NCT01047189|P1|Participant Flow|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
377879|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
377880|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
377881|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
377882|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
377883|NCT01047189|E2|Reported Event|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
377884|NCT01047189|E1|Reported Event|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
377885|NCT01046903|B1|Baseline|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377886|NCT01046903|P1|Participant Flow|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks.
377887|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377888|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377889|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377890|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377891|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377892|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377893|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377894|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377895|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377896|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377897|NCT01046903|E1|Reported Event|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
377898|NCT01046877|B1|Baseline|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377899|NCT01046877|P1|Participant Flow|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377900|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377901|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377902|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377903|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377904|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377905|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377906|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377907|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377908|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377909|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377910|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377911|NCT01046877|E1|Reported Event|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
377912|NCT01046695|B3|Baseline|Total|Total of all reporting groups
377913|NCT01046695|B2|Baseline|Control Arm|This arm will have standard care for their post operative pain control.
377914|NCT01046695|B1|Baseline|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
377915|NCT01046695|P2|Participant Flow|TENS Unit|Once awake from surgery this arm added the use of the TENS unit for 48 hours in addition to standard care for their postoperative pain control. The TENS unit was set to each patients individual preference which included intensity, frequency and the placement of where they wanted the electrodes.
377916|NCT01046695|P1|Participant Flow|Control Arm|Once awake from surgery this arm had standard care for 48 hours for their postoperative pain control using each surgeons usual postoperative medications and procedures.
377917|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
377918|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
377919|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
377920|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
377921|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
377952|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
380819|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
377922|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
377923|NCT01046695|E2|Reported Event|Control Arm|This arm will have standard care for their post operative pain control.
377924|NCT01046695|E1|Reported Event|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
377925|NCT01046682|B3|Baseline|Total|Total of all reporting groups
377926|NCT01046682|B2|Baseline|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
377927|NCT01046682|B1|Baseline|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
377928|NCT01046682|P2|Participant Flow|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
377929|NCT01046682|P1|Participant Flow|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
377930|NCT01046682|O2|Outcome|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
377931|NCT01046682|O1|Outcome|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
377932|NCT01046682|E2|Reported Event|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
377933|NCT01046682|E1|Reported Event|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
377934|NCT01046643|B3|Baseline|Total|Total of all reporting groups
377935|NCT01046643|B2|Baseline|Progesterone and Placebo|"Progesterone treatment (P10)~Participants received both a Progesterone capsule (P10) (200 mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
377936|NCT01046643|B1|Baseline|Estrogen and Placebo|"Estrogen treatment with Estradiol (E2)~Participants received both an Estradiol capsule (E2) (1mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
377937|NCT01046643|P4|Participant Flow|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
377938|NCT01046643|P3|Participant Flow|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days.
377939|NCT01046643|P2|Participant Flow|Progesterone Followed by Placebo|"Progesterone (P10) treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
377940|NCT01046643|P1|Participant Flow|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day"
377941|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377942|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377943|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
377944|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
377945|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377946|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377947|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
377948|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
377949|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377950|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377951|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
377953|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377954|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
377955|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
377956|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
377957|NCT01046643|E4|Reported Event|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
377958|NCT01046643|E3|Reported Event|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) capsule once a day, at the same time each day, for 90 days.
377959|NCT01046643|E2|Reported Event|Progesterone Followed by Placebo|"Progesterone treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
377960|NCT01046643|E1|Reported Event|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day."
377961|NCT01046565|B1|Baseline|Differin® Lotion 0.1% and Differin Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
377962|NCT01046565|P1|Participant Flow|Differin® Lotion 0.1% and Differin® Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream - apply topically to the opposite site of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
377963|NCT01046565|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
377964|NCT01046565|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks
377965|NCT01046565|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
377966|NCT01046565|O2|Outcome|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
377967|NCT01046565|O1|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
377968|NCT01046565|E2|Reported Event|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
377969|NCT01046565|E1|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
377970|NCT01046396|B1|Baseline|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
377971|NCT01046396|P1|Participant Flow|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
377972|NCT01046396|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
377973|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
377974|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
377975|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
377976|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
377977|NCT01046396|E2|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
377978|NCT01046396|E1|Reported Event|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
377979|NCT01046253|B3|Baseline|Total|Total of all reporting groups
377980|NCT01046253|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
377981|NCT01046253|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
377982|NCT01046253|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
377983|NCT01046253|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
377984|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
377985|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
377986|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
377987|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
380820|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
377988|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
377989|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
377990|NCT01046253|E2|Reported Event|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
377991|NCT01046253|E1|Reported Event|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
377992|NCT01046136|B3|Baseline|Total|Total of all reporting groups
377993|NCT01046136|B2|Baseline|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
377994|NCT01046136|B1|Baseline|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
377995|NCT01046136|P2|Participant Flow|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
377996|NCT01046136|P1|Participant Flow|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
377997|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
377998|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
377999|NCT01046136|O2|Outcome|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
378000|NCT01046136|O1|Outcome|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
378001|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
378002|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
378003|NCT01046136|E2|Reported Event|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
378004|NCT01046136|E1|Reported Event|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
378005|NCT01046110|B3|Baseline|Total|Total of all reporting groups
378006|NCT01046110|B2|Baseline|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
378007|NCT01046110|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
378008|NCT01046110|P2|Participant Flow|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
378009|NCT01046110|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
378010|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
378011|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
378012|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
378013|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
378014|NCT01046110|E2|Reported Event|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
378015|NCT01046110|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
378016|NCT01046084|B3|Baseline|Total|Total of all reporting groups
378017|NCT01046084|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
378018|NCT01046084|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
378019|NCT01046084|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
378020|NCT01046084|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
378021|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
378022|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
378023|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
378024|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
378025|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
378026|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
378027|NCT01046084|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
378028|NCT01046084|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
378029|NCT01045993|B5|Baseline|Total|Total of all reporting groups
378030|NCT01045993|B4|Baseline|Oral Placebo|Oral Placebo matching Oral IBU.
378031|NCT01045993|B3|Baseline|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378032|NCT01045993|B2|Baseline|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378033|NCT01045993|B1|Baseline|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378034|NCT01045993|P4|Participant Flow|Oral Placebo|Oral Placebo matching Oral IBU.
378035|NCT01045993|P3|Participant Flow|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378036|NCT01045993|P2|Participant Flow|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378037|NCT01045993|P1|Participant Flow|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378038|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378039|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378040|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378041|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378042|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378043|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378044|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378045|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378046|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378047|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378048|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378049|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378050|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378051|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378052|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378053|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378054|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378055|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378056|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378057|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378058|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378059|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378060|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378061|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378062|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378063|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378064|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378065|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378066|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378067|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378068|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378069|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378070|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378071|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378072|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378919|NCT01043185|E3|Reported Event|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
378073|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378074|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378075|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378076|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378077|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378078|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378079|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378080|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378081|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378082|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378083|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378084|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378085|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378086|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378087|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378088|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378089|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378090|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378091|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378092|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378093|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378094|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378095|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378096|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378097|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378098|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378099|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378100|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378101|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378102|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
378103|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378104|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378105|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378106|NCT01045993|E4|Reported Event|Oral Placebo|Oral Placebo matching Oral IBU.
378107|NCT01045993|E3|Reported Event|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
378108|NCT01045993|E2|Reported Event|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
378109|NCT01045993|E1|Reported Event|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
378110|NCT01045967|B3|Baseline|Total|Total of all reporting groups
378111|NCT01045967|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
378112|NCT01045967|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
378113|NCT01045967|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
378114|NCT01045967|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
378115|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
378116|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
378117|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
378118|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
378119|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
378120|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
378121|NCT01045967|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
378122|NCT01045967|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
378123|NCT01045798|B3|Baseline|Total|Total of all reporting groups
378124|NCT01045798|B2|Baseline|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
378125|NCT01045798|B1|Baseline|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
378126|NCT01045798|P2|Participant Flow|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
378127|NCT01045798|P1|Participant Flow|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
378128|NCT01045798|O2|Outcome|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
378129|NCT01045798|O1|Outcome|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
378130|NCT01045798|E2|Reported Event|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
378131|NCT01045798|E1|Reported Event|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
378132|NCT01045707|B3|Baseline|Total|Total of all reporting groups
378133|NCT01045707|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378134|NCT01045707|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378135|NCT01045707|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378136|NCT01045707|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378137|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378138|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378139|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378140|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378141|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378142|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378143|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378144|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378145|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378146|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
380821|NCT01037244|O4|Outcome|Placebo|Placebo tablets
378147|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378148|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378149|NCT01045707|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
378150|NCT01045707|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
378151|NCT01045694|B1|Baseline|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
378152|NCT01045694|P1|Participant Flow|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
378153|NCT01045694|O1|Outcome|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
378154|NCT01045694|O1|Outcome|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
378155|NCT01045694|O1|Outcome|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution"
378156|NCT01045694|E1|Reported Event|Arthritis Treatment|"Participants received one of three treatments:~Botulism Toxin Type A: One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule~Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine~Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution~8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group."
378157|NCT01045551|B1|Baseline|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
378158|NCT01045551|P1|Participant Flow|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
378159|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
378160|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
378161|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
378162|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
378163|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
378164|NCT01045551|E1|Reported Event|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks~The most frequently reported adverse event (AE) was infection. One patient (a 74 year old female) experienced 2 urinary tract infections during the course of the study, and another (a 63 year old female) experienced one urinary tract infection. Two patients experienced upper respiratory infections, which have previously been reported in patients taking apremilast. The second most common AE was loose stool, reported by two patients, which resolved quickly and without recurrence. All AE’s were reported as mild and no patient withdrew from the study due to AEs. No patient required dosing modification or discontinuation."
378165|NCT01045447|B3|Baseline|Total|Total of all reporting groups
378166|NCT01045447|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
378167|NCT01045447|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
378168|NCT01045447|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
378281|NCT01045187|O1|Outcome|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
378169|NCT01045447|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
378170|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
378171|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
378172|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
378173|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
378174|NCT01045447|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
378175|NCT01045447|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
378176|NCT01045421|B7|Baseline|Total|Total of all reporting groups
378177|NCT01045421|B6|Baseline|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378178|NCT01045421|B5|Baseline|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378179|NCT01045421|B4|Baseline|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378180|NCT01045421|B3|Baseline|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378181|NCT01045421|B2|Baseline|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378182|NCT01045421|B1|Baseline|Phase 1: MLN8237- All Participants|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose-escalation or pancreatic cancer cohort during Phase 1 portion of the study.
378183|NCT01045421|P11|Participant Flow|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378184|NCT01045421|P10|Participant Flow|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378185|NCT01045421|P9|Participant Flow|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378186|NCT01045421|P8|Participant Flow|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378187|NCT01045421|P7|Participant Flow|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378188|NCT01045421|P6|Participant Flow|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
378189|NCT01045421|P5|Participant Flow|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378190|NCT01045421|P4|Participant Flow|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378191|NCT01045421|P3|Participant Flow|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378192|NCT01045421|P2|Participant Flow|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378193|NCT01045421|P1|Participant Flow|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378194|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378195|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378196|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378197|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378198|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378199|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378200|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
378201|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378202|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378203|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378204|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378205|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
378206|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378207|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378208|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378209|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378210|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
378211|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378212|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378213|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378214|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378215|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
378216|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378217|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378218|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378219|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378220|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
378221|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378222|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378223|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378224|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378225|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
378226|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378227|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378228|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378229|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378230|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
378231|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378232|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378233|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378234|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378235|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378236|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378237|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378238|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378239|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378240|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378241|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378242|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378282|NCT01045187|E1|Reported Event|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
378283|NCT01045161|B4|Baseline|Total|Total of all reporting groups
378920|NCT01043185|E2|Reported Event|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
378243|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378244|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378245|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378246|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378247|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378248|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378249|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378250|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378251|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378252|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378253|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378254|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378255|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378256|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378257|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378258|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378259|NCT01045421|O6|Outcome|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
380822|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
378260|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378261|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378262|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378263|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378264|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
378265|NCT01045421|E7|Reported Event|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
378266|NCT01045421|E6|Reported Event|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
378267|NCT01045421|E5|Reported Event|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
378268|NCT01045421|E4|Reported Event|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
378269|NCT01045421|E3|Reported Event|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
378270|NCT01045421|E2|Reported Event|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
378271|NCT01045421|E1|Reported Event|Phase 1: MLN8237- Dose Escalation|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose escalation cohort during Phase 1 portion of the study.
378272|NCT01045265|B1|Baseline|Men on Raltegravir|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
378273|NCT01045265|P1|Participant Flow|Men on Raltegravir|HIV-infected men on chronic therapy with raltegravir 400 mg per day as part of antiretroviral therapy regimen.
378274|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
378275|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
378276|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
378277|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
378278|NCT01045265|E1|Reported Event|Men on Raltegravir|HIV-infected men receiving chronic therapy with raltegravir 400 mg per day as part of antiretroviral regimen.
378279|NCT01045187|B1|Baseline|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
378280|NCT01045187|P1|Participant Flow|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
378284|NCT01045161|B3|Baseline|Aclidinium Bromide(AB) 400μg Part A / AB 400μg to 400μg Part B|"Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks."
378285|NCT01045161|B2|Baseline|Aclidinium Bromide(AB) 200μg Part A / AB 200μg to 400μg Part B|"Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks."
378286|NCT01045161|B1|Baseline|Placebo Part A / Placebo to Aclidinium Bromide 400μg Part B|"Dose-matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks."
378287|NCT01045161|P3|Participant Flow|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients continued to receive Aclidinium bromide, 400 microgram dose as an open-label treatment for an additional 40 weeks
378288|NCT01045161|P2|Participant Flow|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients who were Aclidinium bromide 200 microgram dose, received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
378289|NCT01045161|P1|Participant Flow|Placebo - Part A Placebo to Aclidinium Bromide 400 μg - Part B|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment. After 12 weeks, patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
378290|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 400 μg dose, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg switched to open label 400µg aclidinium bromide for 40 weeks
378291|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg switched to open label 400µg aclidinium bromide for 40 weeks
378292|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo switched to open label 400µg aclidinium bromide for 40 weeks
378293|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients received open label 400µg aclidinium bromide for 40 additional weeks
378294|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 200 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg were switched to open label 400µg aclidinium bromide for 40 weeks.
378295|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on placebo were switched to open label 400µg aclidinium bromide for 40 weeks
378296|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
378297|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
378298|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
378299|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
378300|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
378301|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
378302|NCT01045161|E6|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg - Part B|After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.
378303|NCT01045161|E5|Reported Event|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg - Part B|Part B - After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.
378304|NCT01045161|E4|Reported Event|Placebo to Aclidinium Bromide 400 μg - Part B|After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
378305|NCT01045161|E3|Reported Event|Aclidinium Bromide 400 μg - Part A|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment.
378306|NCT01045161|E2|Reported Event|Aclidinium Bromide 200 μg - Part A|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment.
378307|NCT01045161|E1|Reported Event|Placebo - Part A|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment.
378308|NCT01045122|B1|Baseline|Propofol vs Dexmedetomidine|We aim to study two commonly used sedatives (propofol vs dexmedetomidine) in subjects with OSA for their propensity to produce sedation related respiratory events
378309|NCT01045122|P2|Participant Flow|Dexmedetomidine First|Dexmedetomidine was administered on the first day in 6/11 subjects with at least a one week washout between runs before the subjects underwent the experiment with propofol.
378310|NCT01045122|P1|Participant Flow|Propofol First|Propofol was administered first in 5/11 subjects with a one week washout at least between the next run with dexmedetomidine
378311|NCT01045122|O2|Outcome|Dexmedetomidine|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
378312|NCT01045122|O1|Outcome|Propofol|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
378435|NCT01044732|O1|Outcome|All SC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during standard colonoscopies (SC)
378313|NCT01045122|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.~Dexmedetomidine: For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr."
378314|NCT01045122|E1|Reported Event|Propofol|"Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties.~Propofol: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained."
378315|NCT01045096|B4|Baseline|Total|Total of all reporting groups
378316|NCT01045096|B3|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378317|NCT01045096|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378318|NCT01045096|B1|Baseline|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378319|NCT01045096|P3|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378320|NCT01045096|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378321|NCT01045096|P1|Participant Flow|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378322|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378323|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378324|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378325|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378326|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378327|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378328|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378329|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378330|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378331|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378332|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378333|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378334|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378335|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378336|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378337|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378338|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378339|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378340|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378341|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378342|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378343|NCT01045096|E3|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
378344|NCT01045096|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
378345|NCT01045096|E1|Reported Event|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
378346|NCT01045057|B1|Baseline|Provox Vega Puncture Set|Group of larynx cancer patients undergoing a total laryngectomy whereby the puncture and placement of the voice prosthesis is done with the Provox Vega Puncture Set
378347|NCT01045057|P1|Participant Flow|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Vega Puncture Set
378348|NCT01045057|O1|Outcome|Secondary Puncture|Patients who had a secondary puncture
378349|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
378350|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
378351|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
378352|NCT01045057|E1|Reported Event|Provox Vega Puncture Set|Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set
378353|NCT01045031|B3|Baseline|Total|Total of all reporting groups
378354|NCT01045031|B2|Baseline|Controls|The control group was matched according to age, sex and years of education.
378921|NCT01043185|E1|Reported Event|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
378355|NCT01045031|B1|Baseline|Marathon Athletes|Participation in more than one of the following competitions during the previous three years: Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km)
378356|NCT01045031|P2|Participant Flow|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
378357|NCT01045031|P1|Participant Flow|Controls|The control group was matched according to age, sex and years of education.
378358|NCT01045031|O2|Outcome|Marathon Athletes|Runners participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km). Inclusion criteria:1) participation in at least one of these 3 marathons in the preceding two years,2)still in continuous training during the recruitment phase (at least 2 hours/week), 3) aged over 60. Exclusion criteria:(a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (c) diseases that markedly affect CNS functions (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake > 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent.
378359|NCT01045031|O1|Outcome|Controls|Controls were subsequently contacted via personal contact and three additional advertisements (two in an Austrian newspaper (“Krone”) and one in an Austrian bicyclist journal (“Bicyclist Sports”). The controls were matched according to age, sex and years of education
378360|NCT01045031|O2|Outcome|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
378361|NCT01045031|O1|Outcome|Controls|The control group was matched according to age, sex and years of education.
378362|NCT01045031|O2|Outcome|Controls|Brain-derived Neurotrophic Factor (BDNF)
378363|NCT01045031|O1|Outcome|Marathon Athletes|Brain-derived Neurotrophic Factor (BDNF)
378364|NCT01045031|E2|Reported Event|Athletes|
378365|NCT01045031|E1|Reported Event|Controls|
378366|NCT01044862|B4|Baseline|Total|Total of all reporting groups
378367|NCT01044862|B3|Baseline|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
378368|NCT01044862|B2|Baseline|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
378369|NCT01044862|B1|Baseline|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
378370|NCT01044862|P3|Participant Flow|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
378371|NCT01044862|P2|Participant Flow|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
378372|NCT01044862|P1|Participant Flow|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
378373|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
378374|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
378482|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
378375|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
378376|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
378377|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
378378|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
378379|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
378380|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
378381|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
378382|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
378383|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
378384|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
378385|NCT01044862|E3|Reported Event|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
378386|NCT01044862|E2|Reported Event|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
378387|NCT01044862|E1|Reported Event|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
378388|NCT01044771|B1|Baseline|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
378389|NCT01044771|P1|Participant Flow|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day"
378390|NCT01044771|O1|Outcome|Viral Rebound|Every participant in the study switched to the investigational strategy
378391|NCT01044771|O1|Outcome|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients~change from tenofovir to raltegravir: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID"
378392|NCT01044771|E1|Reported Event|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
378393|NCT01044758|B8|Baseline|Total|Total of all reporting groups
378394|NCT01044758|B7|Baseline|Control_Placebo First, Then Placebo|"Healthy control~placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378395|NCT01044758|B6|Baseline|aMCI_Placebo First, Then 250mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)"
378396|NCT01044758|B5|Baseline|aMCI_250mg Drug First, Then Placebo|"Amnestic MCI:~250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378397|NCT01044758|B4|Baseline|aMCI_Placebo First, Then 125mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)"
378398|NCT01044758|B3|Baseline|aMCI_125mg Drug First, Then Placebo|"Amnestic MCI:~125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378399|NCT01044758|B2|Baseline|aMCI_Placebo First, Then 62.5mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)"
378400|NCT01044758|B1|Baseline|aMCI_62.5mg Drug First, Then Placebo|"Amnestic MCI:~62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378401|NCT01044758|P7|Participant Flow|Control_Placebo First, Then Placebo|"Healthy control:~placebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378402|NCT01044758|P6|Participant Flow|aMCI_Placebo First, Then 250mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)"
378403|NCT01044758|P5|Participant Flow|aMCI_250mg Drug First, Then Placebo|"Amnestic MCI:~250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378404|NCT01044758|P4|Participant Flow|aMCI_Placebo First, Then 125mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)"
378405|NCT01044758|P3|Participant Flow|aMCI_125mg Drug First, Then Placebo|"Amnestic MCI:~125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378406|NCT01044758|P2|Participant Flow|aMCI_Placebo First, Then 62.5mg Drug|"Amnestic MCI:~Placebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)"
378407|NCT01044758|P1|Participant Flow|aMCI_62.5mg Drug First, Then Placebo|"Amnestic MCI:~62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)"
378408|NCT01044758|O7|Outcome|Age Matched Control|Placebo capsule twice daily for two weeks
378409|NCT01044758|O6|Outcome|aMCI_250 Placebo|250mg levetiracetam placebo comparator
378410|NCT01044758|O5|Outcome|aMCI_250|250mg levetiracetam twice daily for two weeks
378411|NCT01044758|O4|Outcome|aMCI_125 Placebo|125mg levetiracetam placebo comparator
378412|NCT01044758|O3|Outcome|aMCI_125|125mg levetiracetam twice daily for two weeks
378413|NCT01044758|O2|Outcome|aMCI_62.5 Placebo|62.6mg levetiracetam placebo comparator
378414|NCT01044758|O1|Outcome|aMCI_62.5|62.5mg levetiracetam twice daily for two weeks
378415|NCT01044758|O7|Outcome|Age Matched Control|Placebo capsule twice daily for two weeks
378416|NCT01044758|O6|Outcome|aMCI_250 Placebo|250mg levetiracetam placebo comparator
378417|NCT01044758|O5|Outcome|aMCI_250|250mg levetiracetam twice daily for two weeks
378418|NCT01044758|O4|Outcome|aMCI_125 Placebo|125mg levetiracetam placebo comparator
378419|NCT01044758|O3|Outcome|aMCI_125|125 mg Levetiracetam twice daily for two weeks.
378420|NCT01044758|O2|Outcome|aMCI_62.5 Placebo|62.5mg levetiracetam placebo comparator
378421|NCT01044758|O1|Outcome|aMCI_62.5|62.5 mg levetiracetam twice daily for two weeks
378422|NCT01044758|E7|Reported Event|Age Matched Control|placebo capsule twice daily for two weeks
378423|NCT01044758|E6|Reported Event|aMCI_250 Placebo|250 mg placebo comparator (placebo capsule twice daily for two weeks)
378424|NCT01044758|E5|Reported Event|aMCI_250|250 mg levetiracetam twice daily for two weeks
378425|NCT01044758|E4|Reported Event|aMCI_125 Placebo|125 mg placebo comparator (placebo capsule twice daily for two weeks)
378426|NCT01044758|E3|Reported Event|aMCI_125|125 mg levetiracetam twice daily for two weeks
378427|NCT01044758|E2|Reported Event|aMCI_62.5 Placebo|62.5 mg placebo comparator (placebo capsule twice daily for two weeks)
378428|NCT01044758|E1|Reported Event|aMCI_62.5|62.5 mg levetiracetam twice daily for two weeks
378429|NCT01044732|B3|Baseline|Total|Total of all reporting groups
378430|NCT01044732|B2|Baseline|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378431|NCT01044732|B1|Baseline|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378432|NCT01044732|P2|Participant Flow|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378433|NCT01044732|P1|Participant Flow|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378434|NCT01044732|O2|Outcome|All TEC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during Third Eye colonoscopies (TEC)
378483|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
378436|NCT01044732|O2|Outcome|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378437|NCT01044732|O1|Outcome|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378438|NCT01044732|E2|Reported Event|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378439|NCT01044732|E1|Reported Event|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
378440|NCT01044706|B3|Baseline|Total|Total of all reporting groups
378441|NCT01044706|B2|Baseline|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
378442|NCT01044706|B1|Baseline|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
378443|NCT01044706|P2|Participant Flow|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
378444|NCT01044706|P1|Participant Flow|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
378445|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
378446|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
378447|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
378448|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
378449|NCT01044706|E2|Reported Event|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
378450|NCT01044706|E1|Reported Event|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
378451|NCT01044693|B1|Baseline|All Study Participants|Participants who were randomized to receive placebo, metoprolol, sildenafil and nebivolol in any order
378452|NCT01044693|P16|Participant Flow|Placebo Then Nebivolol Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378453|NCT01044693|P15|Participant Flow|Nebivolol Then Placebo Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378454|NCT01044693|P14|Participant Flow|Nebivolol Then Sildenafil Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378455|NCT01044693|P13|Participant Flow|Sildenafil Then Metoprolol Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378456|NCT01044693|P12|Participant Flow|Sildenafil Then Nebivolol Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378457|NCT01044693|P11|Participant Flow|Metoprolol Then Sildenafil Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378458|NCT01044693|P10|Participant Flow|Metoprolol Then Nebivolol Then Placebo Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378459|NCT01044693|P9|Participant Flow|Nebivolol Then Metoprolol Then Sildenafil Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378460|NCT01044693|P8|Participant Flow|Metoprolol Then Placebo Then Nebivolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378461|NCT01044693|P7|Participant Flow|Sildenafil Then Nebivolol Then Placebo Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378462|NCT01044693|P6|Participant Flow|Metoprolol Then Sildenafil Then Placebo Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378463|NCT01044693|P5|Participant Flow|Nebivolol Then Placebo Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378464|NCT01044693|P4|Participant Flow|Placebo Then Sildenafil Then Metoprolol Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378465|NCT01044693|P3|Participant Flow|Placebo Then Sildenafil Then Nebivolol Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378466|NCT01044693|P2|Participant Flow|Placebo Then Nebivolol Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378467|NCT01044693|P1|Participant Flow|Placebo Then Metoprolol Then Sildenafil Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
378468|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
378469|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
378470|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
378471|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
378472|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
378473|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
378474|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
378475|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
378476|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
378477|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
378478|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
378479|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
378480|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
378481|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
378484|NCT01044693|E4|Reported Event|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
378485|NCT01044693|E3|Reported Event|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
378486|NCT01044693|E2|Reported Event|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
378487|NCT01044693|E1|Reported Event|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
378488|NCT01044589|B3|Baseline|Total|Total of all reporting groups
378489|NCT01044589|B2|Baseline|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378490|NCT01044589|B1|Baseline|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378491|NCT01044589|P2|Participant Flow|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378492|NCT01044589|P1|Participant Flow|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378493|NCT01044589|O2|Outcome|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378494|NCT01044589|O1|Outcome|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378495|NCT01044589|O2|Outcome|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378496|NCT01044589|O1|Outcome|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378497|NCT01044589|E2|Reported Event|Biodesign Tissue Repair Graft|"Biodesign Tissue Repair Graft~Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378498|NCT01044589|E1|Reported Event|Overlapping Sphincter Repair|"Control~Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone"
378499|NCT01044537|B8|Baseline|Total|Total of all reporting groups
378500|NCT01044537|B7|Baseline|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378501|NCT01044537|B6|Baseline|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378502|NCT01044537|B5|Baseline|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378503|NCT01044537|B4|Baseline|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378504|NCT01044537|B3|Baseline|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378505|NCT01044537|B2|Baseline|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378506|NCT01044537|B1|Baseline|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378507|NCT01044537|P7|Participant Flow|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378508|NCT01044537|P6|Participant Flow|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378509|NCT01044537|P5|Participant Flow|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378510|NCT01044537|P4|Participant Flow|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378511|NCT01044537|P3|Participant Flow|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378512|NCT01044537|P2|Participant Flow|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378513|NCT01044537|P1|Participant Flow|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378514|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378515|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378516|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378517|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378518|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378519|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378520|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378521|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378522|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378523|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378524|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378525|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378526|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378527|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378528|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378529|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378530|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378531|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378532|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378533|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378534|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378535|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378536|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378537|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378538|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378539|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378540|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378541|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378542|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378543|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378544|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378545|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378546|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378547|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378548|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378549|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378550|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378551|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378552|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378553|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378554|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378555|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378556|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378557|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378558|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378559|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378560|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378561|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378562|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378563|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378564|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378565|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378566|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378567|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378568|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378569|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378570|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378571|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378572|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378573|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378574|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378575|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378576|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378577|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378578|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378579|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378580|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378581|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378582|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378583|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378584|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378585|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378586|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378587|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378588|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378589|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378590|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378591|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378592|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378593|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378594|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378595|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378596|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378597|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378598|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378599|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378600|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378601|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378602|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378603|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378604|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378605|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378606|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378607|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378608|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378609|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378610|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378611|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378612|NCT01044537|E7|Reported Event|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
378613|NCT01044537|E6|Reported Event|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
378614|NCT01044537|E5|Reported Event|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
378615|NCT01044537|E4|Reported Event|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
378616|NCT01044537|E3|Reported Event|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
378617|NCT01044537|E2|Reported Event|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
378618|NCT01044537|E1|Reported Event|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
378619|NCT01044498|B3|Baseline|Total|Total of all reporting groups
378620|NCT01044498|B2|Baseline|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378621|NCT01044498|B1|Baseline|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378622|NCT01044498|P2|Participant Flow|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378623|NCT01044498|P1|Participant Flow|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378624|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378625|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378626|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378627|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378628|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378629|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378630|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378631|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378632|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378633|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378634|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378635|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378636|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378637|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378638|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378639|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378640|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378641|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378642|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378643|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378644|NCT01044498|E2|Reported Event|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
378645|NCT01044498|E1|Reported Event|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
378646|NCT01044459|B3|Baseline|Total|Total of all reporting groups
378647|NCT01044459|B2|Baseline|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378648|NCT01044459|B1|Baseline|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378649|NCT01044459|P2|Participant Flow|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378650|NCT01044459|P1|Participant Flow|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378651|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378652|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378653|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378654|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378655|NCT01044459|E2|Reported Event|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378656|NCT01044459|E1|Reported Event|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
378657|NCT01044303|B1|Baseline|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
378658|NCT01044303|P1|Participant Flow|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
378659|NCT01044303|O3|Outcome|Renal Function|Number of patients who had stable renal function throughout the study.
378660|NCT01044303|O2|Outcome|Rate of Rejection|Number of patients who had a rejection during the course of the study.
378661|NCT01044303|O1|Outcome|Rate of Infection|Number of patients who had an infection during the course of the study.
378662|NCT01044303|O1|Outcome|Mycophenolic Acid (MPA) Escalation|Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months
378663|NCT01044303|E1|Reported Event|Adverse Events|Adverse events reported by participants during the course of the study.
378664|NCT01044290|B4|Baseline|Total|Total of all reporting groups
378665|NCT01044290|B3|Baseline|Arm 3 Treatment as Usual|"Subjects in the third group (Treatment as Usual) were exposed to no intervention or attention control during the intervention window."
378666|NCT01044290|B2|Baseline|Arm 2 Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
378667|NCT01044290|B1|Baseline|Arm 1 -Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on issues of heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
378668|NCT01044290|P3|Participant Flow|Arm 3 Treatment as Usual|"Subjects in the third group (treatment as usual) were exposed to no intervention or attention control during the intervention window."
378669|NCT01044290|P2|Participant Flow|Attention Control|"Subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
378670|NCT01044290|P1|Participant Flow|Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy."
378671|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
378672|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received relaxation meditation as the attention control condition
378673|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
378674|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual.
378675|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control.
378676|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
378677|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants did not receive any intervention but rather care as usual.
378678|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition
378679|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
378680|NCT01044290|O3|Outcome|Arm 3 Usual Care|Participants did not receive any intervention but rather care as usual.
378681|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition.
378682|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
378683|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
378684|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control condition.
378685|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
378686|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual
378687|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control
378688|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
378689|NCT01044290|E3|Reported Event|Treatment as Usual|"Subjects in the third group (treatment as usual) will be exposed to no intervention or attention control during the intervention window."
378690|NCT01044290|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD."
378763|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
378691|NCT01044290|E1|Reported Event|Outlook Intervention|"Subjects in the first group (Life Completion) will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
378692|NCT01044264|B4|Baseline|Total|Total of all reporting groups
378693|NCT01044264|B3|Baseline|Placebo|Placebo : Placebo
378694|NCT01044264|B2|Baseline|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378695|NCT01044264|B1|Baseline|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378696|NCT01044264|P3|Participant Flow|Placebo|Placebo : Placebo
378697|NCT01044264|P2|Participant Flow|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378698|NCT01044264|P1|Participant Flow|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378699|NCT01044264|O3|Outcome|Placebo|Placebo : Placebo
378700|NCT01044264|O2|Outcome|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378701|NCT01044264|O1|Outcome|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378702|NCT01044264|E3|Reported Event|Placebo|Placebo : Placebo
378703|NCT01044264|E2|Reported Event|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378704|NCT01044264|E1|Reported Event|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
378705|NCT01044212|B3|Baseline|Total|Total of all reporting groups
378706|NCT01044212|B2|Baseline|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
378707|NCT01044212|B1|Baseline|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
378708|NCT01044212|P2|Participant Flow|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
378709|NCT01044212|P1|Participant Flow|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
378710|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
378711|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
378712|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
378713|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
378714|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
378715|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
378716|NCT01044212|E2|Reported Event|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
378717|NCT01044212|E1|Reported Event|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
378718|NCT01044056|B4|Baseline|Total|Total of all reporting groups
378719|NCT01044056|B3|Baseline|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
378720|NCT01044056|B2|Baseline|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
378721|NCT01044056|B1|Baseline|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
378722|NCT01044056|P3|Participant Flow|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
378723|NCT01044056|P2|Participant Flow|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
378724|NCT01044056|P1|Participant Flow|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
378725|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
378726|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
378727|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
378728|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
378729|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
378730|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
378731|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
378732|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
378733|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
378734|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
378735|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
378736|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
378737|NCT01044056|E3|Reported Event|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE
378738|NCT01044056|E2|Reported Event|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day.
378739|NCT01044056|E1|Reported Event|Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days.
378740|NCT01044030|B3|Baseline|Total|Total of all reporting groups
378741|NCT01044030|B2|Baseline|Placebo|Placebo: 7.5 mL by mouth three times daily
378742|NCT01044030|B1|Baseline|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
378743|NCT01044030|P2|Participant Flow|Placebo|Placebo: 7.5 mL by mouth three times daily
378744|NCT01044030|P1|Participant Flow|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
378745|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
378746|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
378747|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
378748|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
378749|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
378750|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
378751|NCT01044030|E2|Reported Event|Placebo|Placebo: 7.5 mL by mouth three times daily
378752|NCT01044030|E1|Reported Event|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
378753|NCT01043939|B1|Baseline|Entire Study Population|Includes groups randomized to receive purple grape juice first and apple juice first
378754|NCT01043939|P2|Participant Flow|Arm 2 Apple Juice Then Purple Grape Juice|Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).
378755|NCT01043939|P1|Participant Flow|Arm 1 Purple Grape Juice Then Apple Juice|Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).
378756|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
378757|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
378758|NCT01043939|O2|Outcome|Arm 2 Apple Juice Then Purple Grape Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
378759|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
378760|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
378761|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
378762|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
378764|NCT01043939|E2|Reported Event|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
378765|NCT01043939|E1|Reported Event|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
378766|NCT01043926|B3|Baseline|Total|Total of all reporting groups
378767|NCT01043926|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378768|NCT01043926|B1|Baseline|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378769|NCT01043926|P4|Participant Flow|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
378770|NCT01043926|P3|Participant Flow|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
378771|NCT01043926|P2|Participant Flow|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378772|NCT01043926|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378773|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378774|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378775|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378776|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378777|NCT01043926|O2|Outcome|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
378778|NCT01043926|O1|Outcome|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
378779|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378780|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378781|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378782|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378783|NCT01043926|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378784|NCT01043926|E1|Reported Event|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
378785|NCT01043874|B1|Baseline|Nilotinib|Nilotinib 400 mg BID
378786|NCT01043874|P1|Participant Flow|Nilotinib|Nilotinib 400 mg BID
378787|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
378788|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
378789|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
378790|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
378791|NCT01043874|E1|Reported Event|Nilotinib|Nilotinib 400 mg BID
378792|NCT01043705|B4|Baseline|Total|Total of all reporting groups
378793|NCT01043705|B3|Baseline|CIED Replacement With CRT and TYRX Vs. Case Match Arm|Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients
378794|NCT01043705|B2|Baseline|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
378795|NCT01043705|B1|Baseline|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
378796|NCT01043705|P3|Participant Flow|CRT With no TYRX Retrospective Case Control|Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
378797|NCT01043705|P2|Participant Flow|CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants|Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match
378798|NCT01043705|P1|Participant Flow|ICD With TYRX Implant|All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant
378799|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
378800|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
378801|NCT01043705|O1|Outcome|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
378802|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
378803|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
378804|NCT01043705|O1|Outcome|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
378805|NCT01043705|E2|Reported Event|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
378806|NCT01043705|E1|Reported Event|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
378807|NCT01043653|B1|Baseline|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
378808|NCT01043653|P1|Participant Flow|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
378809|NCT01043653|O1|Outcome|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
378810|NCT01043653|O1|Outcome|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
378811|NCT01043653|E1|Reported Event|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
378812|NCT01043640|B1|Baseline|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378813|NCT01043640|P1|Participant Flow|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378814|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378815|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378816|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378817|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378842|NCT01043523|O1|Outcome|Precontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
378818|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378819|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378820|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378821|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378822|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378823|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378824|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378825|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378915|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
378916|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
378826|NCT01043640|E1|Reported Event|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
378827|NCT01043562|B1|Baseline|Pediatric ICD Pts|"Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).~Defibrillator threshold testing: Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricula"
378828|NCT01043562|P1|Participant Flow|Pediatric ICD Pts|"Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).~Defibrillator threshold testing: Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricula"
378829|NCT01043562|O1|Outcome|Post-shock Pacing Assessment|In addition to the baseline study inclusion criteria, this arm included only patients who met the additional inclusion criteria of adequate sinus node function and intact AV node conduction.
378830|NCT01043562|O2|Outcome|Non-transvenous ICDs|Patients with an implanted defibrillator system utilizing a nontransvenous high voltage coil/defibrillator lead.
378831|NCT01043562|O1|Outcome|Transvenous ICDs|Patients with an implanted defibrillator system utilizing a transvenous high voltage coil/defibrillator lead.
378832|NCT01043562|O1|Outcome|Pediatric ICD Pts|Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).
378833|NCT01043562|E1|Reported Event|Pediatric ICD Pts|Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT).
378834|NCT01043523|B1|Baseline|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378835|NCT01043523|P1|Participant Flow|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378836|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378837|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378838|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378839|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378840|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378841|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
378843|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378844|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378845|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
378846|NCT01043523|O1|Outcome|Precontrast|45 subjects had a change based on the Precontrast image read
378847|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378848|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378849|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378850|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378851|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378852|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378853|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378854|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378855|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378856|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378857|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
378858|NCT01043523|E1|Reported Event|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
378859|NCT01043432|B5|Baseline|Total|Total of all reporting groups
378860|NCT01043432|B4|Baseline|No TBI and no History of Suicidal Behavior Group 4|No TBI and no history of suicidal behavior
378861|NCT01043432|B3|Baseline|No TBI and a History of Suicidal Behavior Group 3|No TBI and a history of suicidal behavior
378862|NCT01043432|B2|Baseline|Moderate/Severe TBI and no History of Suicidal behaviorGroup 2|Moderate/Severe TBI and no history of suicidal behavior
378863|NCT01043432|B1|Baseline|Moderate/Severe TBI and History of Suicidal Behavior Group 1|Moderate/severe TBI and history of suicidal behavior
378864|NCT01043432|P4|Participant Flow|Group 4|No TBI and no history of suicidal behavior = 48
378865|NCT01043432|P3|Participant Flow|Group 3|No TBI and a history of suicidal behavior = 12
378866|NCT01043432|P2|Participant Flow|Group 2|Moderate/Severe TBI and no history of suicidal behavior = 51
378867|NCT01043432|P1|Participant Flow|Group 1|Moderate/severe TBI and history of suicidal behavior = 22
378868|NCT01043432|O4|Outcome|Group 4|No TBI and no history of suicidal behavior
378869|NCT01043432|O3|Outcome|Group 3|No TBI and a history of suicidal behavior
378870|NCT01043432|O2|Outcome|Group 2|Moderate/Severe TBI and no history of suicidal behavior
378871|NCT01043432|O1|Outcome|Group 1|Moderate/severe TBI and history of suicidal behavior
378872|NCT01043432|E1|Reported Event|All Groups|
378873|NCT01043393|B3|Baseline|Total|Total of all reporting groups
378874|NCT01043393|B2|Baseline|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378875|NCT01043393|B1|Baseline|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378876|NCT01043393|P2|Participant Flow|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378877|NCT01043393|P1|Participant Flow|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378878|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378879|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378880|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378881|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378882|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378883|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378884|NCT01043393|E2|Reported Event|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378885|NCT01043393|E1|Reported Event|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
378886|NCT01043185|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 10 sequences of drug or placebo.
378887|NCT01043185|P10|Participant Flow|First Placebo, Then 120mg, Then 30mg, Then 240mg|Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
378888|NCT01043185|P9|Participant Flow|First 240mg, Then 30mg, Then 90mg, Then Placebo|Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period.
378889|NCT01043185|P8|Participant Flow|First 120mg, Then 30mg, Then 240mg, Then Placebo|Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period.
378890|NCT01043185|P7|Participant Flow|First 90mg, Then 120mg, Then Placebo, Then 240mg|Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period.
378891|NCT01043185|P6|Participant Flow|First Placebo, Then 240mg, Then 90mg, Then 30mg|Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period.
378892|NCT01043185|P5|Participant Flow|First 90mg, Then Placebo, Then 120mg, Then 240mg|Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
378893|NCT01043185|P4|Participant Flow|First Placebo, Then 30mg, Then 90mg, Then 120mg|Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period.
378894|NCT01043185|P3|Participant Flow|First 120mg, Then Placebo, Then 240mg, Then 90mg|Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period.
378895|NCT01043185|P2|Participant Flow|First 30mg, Then 90mg, Then Placebo, Then 120mg|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period.
378896|NCT01043185|P1|Participant Flow|First 30mg, Then 90mg, Then 120mg, Then Placebo|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period.
378897|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
378898|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
378899|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
378900|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
378901|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
378902|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
378903|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
378904|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
378905|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
378906|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
378907|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
378908|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
378909|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
378910|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
378911|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
378912|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
378913|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
378914|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
378922|NCT01043146|B7|Baseline|Total|Total of all reporting groups
378923|NCT01043146|B6|Baseline|240 mg COR-1|single intravenous administration
378924|NCT01043146|B5|Baseline|160 mg COR-1|single intravenous administration
378925|NCT01043146|B4|Baseline|80 mg COR-1|single intravenous administration
378926|NCT01043146|B3|Baseline|40 mg COR-1|single intravenous administration
378927|NCT01043146|B2|Baseline|10 mg COR-1|single intravenous administration
378928|NCT01043146|B1|Baseline|Placebo|intravenous 0.9 % NaCl
378929|NCT01043146|P6|Participant Flow|240 mg COR-1|single intravenous administration
378930|NCT01043146|P5|Participant Flow|160 mg COR-1|single intravenous administration
378931|NCT01043146|P4|Participant Flow|80 mg COR-1|single intravenous administration
378932|NCT01043146|P3|Participant Flow|40 mg COR-1|single intravenous administration
378933|NCT01043146|P2|Participant Flow|10 mg COR-1|single intravenous administration
378934|NCT01043146|P1|Participant Flow|Placebo|intravenous 0.9 % NaCl
378935|NCT01043146|O6|Outcome|240 mg COR-1|single intravenous administration
378936|NCT01043146|O5|Outcome|160 mg COR-1|single intravenous administration
378937|NCT01043146|O4|Outcome|80 mg COR-1|single intravenous administration
378938|NCT01043146|O3|Outcome|40 mg COR-1|single intravenous administration
378939|NCT01043146|O2|Outcome|10 mg COR-1|single intravenous administration
378940|NCT01043146|O1|Outcome|Placebo|intravenous 0.9 % NaCl
378941|NCT01043146|E6|Reported Event|240 mg COR-1|single intravenous administration
378942|NCT01043146|E5|Reported Event|160 mg COR-1|single intravenous administration
378943|NCT01043146|E4|Reported Event|80 mg COR-1|single intravenous administration
378944|NCT01043146|E3|Reported Event|40 mg COR-1|single intravenous administration
378945|NCT01043146|E2|Reported Event|10 mg COR-1|single intravenous administration
378946|NCT01043146|E1|Reported Event|Placebo|intravenous 0.9 % NaCl
378947|NCT01043133|B3|Baseline|Total|Total of all reporting groups
378948|NCT01043133|B2|Baseline|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
378949|NCT01043133|B1|Baseline|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
378950|NCT01043133|P2|Participant Flow|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
378951|NCT01043133|P1|Participant Flow|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
378952|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
378953|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
378954|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
378955|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
378956|NCT01043133|E2|Reported Event|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
378957|NCT01043133|E1|Reported Event|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
378958|NCT01043094|B3|Baseline|Total|Total of all reporting groups
378959|NCT01043094|B2|Baseline|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
378960|NCT01043094|B1|Baseline|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
378961|NCT01043094|P2|Participant Flow|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
378962|NCT01043094|P1|Participant Flow|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
378963|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
378964|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
378965|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
378966|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
378967|NCT01043094|E2|Reported Event|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
378968|NCT01043094|E1|Reported Event|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
378969|NCT01042977|B3|Baseline|Total|Total of all reporting groups
378970|NCT01042977|B2|Baseline|Placebo|Placebo plus usual care
378971|NCT01042977|B1|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378972|NCT01042977|P2|Participant Flow|Placebo|Placebo plus usual care
378973|NCT01042977|P1|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378974|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
378975|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378976|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
378977|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378978|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
378979|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378980|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
378981|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378982|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
378983|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378984|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
378985|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378986|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
378987|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378988|NCT01042977|E2|Reported Event|Placebo|Placebo plus usual care
378989|NCT01042977|E1|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus usual care
378990|NCT01042938|B3|Baseline|Total|Total of all reporting groups
378991|NCT01042938|B2|Baseline|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378992|NCT01042938|B1|Baseline|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378993|NCT01042938|P2|Participant Flow|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378994|NCT01042938|P1|Participant Flow|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378995|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378996|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378997|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378998|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
378999|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
379000|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
379001|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).
379002|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).
379003|NCT01042938|E2|Reported Event|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
379004|NCT01042938|E1|Reported Event|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
379005|NCT01042795|B1|Baseline|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
379006|NCT01042795|P1|Participant Flow|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
379007|NCT01042795|O1|Outcome|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
379008|NCT01042795|E1|Reported Event|Continuous Daily Dosing of Sunitinib|Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
379009|NCT01042678|B4|Baseline|Total|Total of all reporting groups
379010|NCT01042678|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379011|NCT01042678|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379012|NCT01042678|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379013|NCT01042678|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
379014|NCT01042678|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
379015|NCT01042678|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
379016|NCT01042678|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379017|NCT01042678|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379018|NCT01042678|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379019|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379020|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379021|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379022|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379023|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379024|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379025|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379026|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379027|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379028|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
380823|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
379029|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379030|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379031|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379032|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379033|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379034|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379035|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379036|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379037|NCT01042678|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
379038|NCT01042678|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
379039|NCT01042678|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
379040|NCT01042613|B3|Baseline|Total|Total of all reporting groups
379041|NCT01042613|B2|Baseline|Standard|(standard technique of insertion of the intravenous cannula)
379042|NCT01042613|B1|Baseline|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
379043|NCT01042613|P2|Participant Flow|Standard|(standard technique of insertion of the intravenous cannula)
379044|NCT01042613|P1|Participant Flow|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
379045|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
379046|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
379047|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
379048|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
379049|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
379050|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
379051|NCT01042613|E2|Reported Event|Standard|(standard technique of insertion of the intravenous cannula)
379052|NCT01042613|E1|Reported Event|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
379053|NCT01042600|B3|Baseline|Total|Total of all reporting groups
379054|NCT01042600|B2|Baseline|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
379055|NCT01042600|B1|Baseline|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
379056|NCT01042600|P2|Participant Flow|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
379057|NCT01042600|P1|Participant Flow|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
379058|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
379059|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
379060|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
379061|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
379062|NCT01042600|E2|Reported Event|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
379063|NCT01042600|E1|Reported Event|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
379064|NCT01042535|B1|Baseline|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379065|NCT01042535|P1|Participant Flow|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379066|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379067|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379068|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379069|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379070|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379071|NCT01042535|E1|Reported Event|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
379072|NCT01042509|B1|Baseline|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
379073|NCT01042509|P1|Participant Flow|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
379074|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
379075|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
379076|NCT01042509|E1|Reported Event|Treatment Group|This study had only one arm
379077|NCT01042496|B3|Baseline|Total|Total of all reporting groups
379078|NCT01042496|B2|Baseline|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379079|NCT01042496|B1|Baseline|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379080|NCT01042496|P2|Participant Flow|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379081|NCT01042496|P1|Participant Flow|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379082|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
379083|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379084|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
379085|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379086|NCT01042496|O4|Outcome|Bipolar Lamotrigine Group as Whole|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
379087|NCT01042496|O3|Outcome|Bipolar Lamotrigine Non-Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~Non-responders were those bipolar participants who did not achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12 at week 12)."
379088|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379089|NCT01042496|O1|Outcome|Bipolar Lamotrigine Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379090|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379091|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379092|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379093|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379094|NCT01042496|E2|Reported Event|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379095|NCT01042496|E1|Reported Event|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
379096|NCT01042392|B3|Baseline|Total|Total of all reporting groups
379097|NCT01042392|B2|Baseline|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379098|NCT01042392|B1|Baseline|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379099|NCT01042392|P4|Participant Flow|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
379100|NCT01042392|P3|Participant Flow|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379101|NCT01042392|P2|Participant Flow|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
379102|NCT01042392|P1|Participant Flow|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379103|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379104|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379105|NCT01042392|O4|Outcome|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
379106|NCT01042392|O3|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379107|NCT01042392|O2|Outcome|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
379108|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379109|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379110|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379111|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379112|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379113|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379145|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379531|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379114|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379115|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379116|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379117|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379118|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379119|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379120|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379121|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379122|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379123|NCT01042392|E4|Reported Event|Placebo to Aliskiren (Period III)|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
379124|NCT01042392|E3|Reported Event|Aliskiren (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379125|NCT01042392|E2|Reported Event|Placebo to Ramipril (Period III)|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
379126|NCT01042392|E1|Reported Event|Ramipril (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
379127|NCT01042366|B4|Baseline|Total|Total of all reporting groups
379128|NCT01042366|B3|Baseline|DCs Fused With Tumor Cells|"DCs fused with tumor cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379532|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379129|NCT01042366|B2|Baseline|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379130|NCT01042366|B1|Baseline|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379131|NCT01042366|P3|Participant Flow|DCs Fused With Tumor Cells|"DCs fused with tumor cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379132|NCT01042366|P2|Participant Flow|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379133|NCT01042366|P1|Participant Flow|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379134|NCT01042366|O3|Outcome|DCs Fused With Tumor Cells|"DCs fused with tumor cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379135|NCT01042366|O2|Outcome|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379136|NCT01042366|O1|Outcome|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379137|NCT01042366|O3|Outcome|DCs Fused With Tumor Cells|"DCs fused with tumor cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379138|NCT01042366|O2|Outcome|DCs Pulsed With Tumor Cell Lysates|"DCs pulsed with tumor cell lysates~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379139|NCT01042366|O1|Outcome|DCs Co-cultured With Melanoma Cells|"DCs co-cultured with melanoma cells~Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.~Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done."
379140|NCT01042366|E1|Reported Event|All Participants (Overall Study)|For all arms: DC vaccine Co-cultured With Melanoma Cells; DC Vaccine Pulsed With Tumor Cell Lysates; DC Vaccines Fused With Tumor Cells
379141|NCT01042288|B1|Baseline|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379142|NCT01042288|P1|Participant Flow|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379143|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379144|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379146|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379147|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379148|NCT01042288|E1|Reported Event|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
379149|NCT01042236|B1|Baseline|Entire Study Population|Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.
379150|NCT01042236|P6|Participant Flow|Sequence CBA|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
379151|NCT01042236|P5|Participant Flow|Sequence BAC|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
379152|NCT01042236|P4|Participant Flow|Sequence ACB|Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
379153|NCT01042236|P3|Participant Flow|Sequence CAB|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
379154|NCT01042236|P2|Participant Flow|Sequence BCA|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
379155|NCT01042236|P1|Participant Flow|Sequence ABC|Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
379156|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379157|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379158|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379159|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379160|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379161|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379162|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379163|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379164|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379165|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379166|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379167|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379168|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379169|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379170|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379171|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379172|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379173|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379174|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379175|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379176|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379177|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379178|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379533|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379179|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379180|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379181|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379182|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379183|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379184|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379185|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379186|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379187|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379188|NCT01042236|E3|Reported Event|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
379189|NCT01042236|E2|Reported Event|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379190|NCT01042236|E1|Reported Event|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
379191|NCT01042158|B1|Baseline|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~Tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
379192|NCT01042158|P1|Participant Flow|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
379193|NCT01042158|O1|Outcome|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
379194|NCT01042158|O1|Outcome|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
379195|NCT01042158|O1|Outcome|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
379196|NCT01042158|O1|Outcome|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
379314|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
379534|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379197|NCT01042158|E1|Reported Event|Tadalafil and Ambrisentan Upfront Therapy|"This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).~tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study."
379198|NCT01042145|B3|Baseline|Total|Total of all reporting groups
379199|NCT01042145|B2|Baseline|Dexamethasone|
379200|NCT01042145|B1|Baseline|Prednisone|
379201|NCT01042145|P2|Participant Flow|Dexamethasone|
379202|NCT01042145|P1|Participant Flow|Prednisone|
379203|NCT01042145|O2|Outcome|Dexamethasone|
379204|NCT01042145|O1|Outcome|Prednisone|
379205|NCT01042145|O2|Outcome|Dexamethasone|
379206|NCT01042145|O1|Outcome|Prednisone|
379207|NCT01042145|O2|Outcome|Dexamethasone|
379208|NCT01042145|O1|Outcome|Prednisone|
379209|NCT01042145|O2|Outcome|Dexamethasone|
379210|NCT01042145|O1|Outcome|Prednisone|
379211|NCT01042145|O2|Outcome|Dexamethasone|
379212|NCT01042145|O1|Outcome|Prednisone|
379213|NCT01042145|O2|Outcome|Dexamethasone|
379214|NCT01042145|O1|Outcome|Prednisone|
379215|NCT01042145|E2|Reported Event|Dexamethasone|
379216|NCT01042145|E1|Reported Event|Prednisone|
379217|NCT01042093|B5|Baseline|Total|Total of all reporting groups
379218|NCT01042093|B4|Baseline|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
379219|NCT01042093|B3|Baseline|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379220|NCT01042093|B2|Baseline|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
379221|NCT01042093|B1|Baseline|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379222|NCT01042093|P4|Participant Flow|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
379223|NCT01042093|P3|Participant Flow|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379224|NCT01042093|P2|Participant Flow|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
379225|NCT01042093|P1|Participant Flow|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379226|NCT01042093|O4|Outcome|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
379227|NCT01042093|O3|Outcome|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379228|NCT01042093|O2|Outcome|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
379229|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379230|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
379231|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379232|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
379233|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379234|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
379235|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379236|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
379237|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379238|NCT01042093|E4|Reported Event|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
379239|NCT01042093|E3|Reported Event|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379240|NCT01042093|E2|Reported Event|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
379241|NCT01042093|E1|Reported Event|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
379242|NCT01041976|B3|Baseline|Total|Total of all reporting groups
379243|NCT01041976|B2|Baseline|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
379244|NCT01041976|B1|Baseline|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
379245|NCT01041976|P2|Participant Flow|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
379515|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379246|NCT01041976|P1|Participant Flow|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
379247|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
379248|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
379249|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
379250|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
379251|NCT01041976|E2|Reported Event|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
379252|NCT01041976|E1|Reported Event|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
379253|NCT01041859|B3|Baseline|Total|Total of all reporting groups
379254|NCT01041859|B2|Baseline|DB Placebo|Double-Blind Placebo Control Group
379255|NCT01041859|B1|Baseline|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379256|NCT01041859|P3|Participant Flow|DB Placebo|Double-Blind Placebo Control Group
379257|NCT01041859|P2|Participant Flow|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379258|NCT01041859|P1|Participant Flow|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
379259|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
379260|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379261|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
379262|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379263|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
379264|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379265|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
379266|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379267|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
379268|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379269|NCT01041859|E3|Reported Event|DB Placebo|Double-Blind Placebo Control Group
379270|NCT01041859|E2|Reported Event|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
379271|NCT01041859|E1|Reported Event|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
379272|NCT01041638|B1|Baseline|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
379273|NCT01041638|P1|Participant Flow|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
379274|NCT01041638|O1|Outcome|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
379275|NCT01041638|E1|Reported Event|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
379276|NCT01041573|B5|Baseline|Total|Total of all reporting groups
379277|NCT01041573|B4|Baseline|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13
379278|NCT01041573|B3|Baseline|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
379279|NCT01041573|B2|Baseline|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
379280|NCT01041573|B1|Baseline|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
379281|NCT01041573|P4|Participant Flow|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
379282|NCT01041573|P3|Participant Flow|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
379283|NCT01041573|P2|Participant Flow|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
379284|NCT01041573|P1|Participant Flow|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
379285|NCT01041573|O4|Outcome|Prevnar|"Subjects aged ≥ 2 to < 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7‐13 (subjects aged ≥ 2 to < 6 months were to receive the fourth Prevnar® vaccination when 12‐15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).~Subjects aged ≥ 6 months to < 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7."
379286|NCT01041573|O3|Outcome|Havrix 720|Havrix®720 0.5 ml im. at day 0 and month 7
379287|NCT01041573|O2|Outcome|IC51, Subjects Aged >= 2 Months to <1 Year|Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
379288|NCT01041573|O1|Outcome|IC51, Subjects Aged >= 1 Year|IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
379289|NCT01041573|E4|Reported Event|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
379290|NCT01041573|E3|Reported Event|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
379291|NCT01041573|E2|Reported Event|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
379292|NCT01041573|E1|Reported Event|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
379293|NCT01041417|B3|Baseline|Total|Total of all reporting groups
379294|NCT01041417|B2|Baseline|Placebo|Saline injection - three times for four weeks
379295|NCT01041417|B1|Baseline|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379296|NCT01041417|P2|Participant Flow|Placebo|Saline injection - three times for four weeks
379297|NCT01041417|P1|Participant Flow|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379298|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379299|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379300|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379301|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379302|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379303|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379304|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379305|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379306|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379307|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379308|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379309|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379310|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
379311|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
379312|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
379313|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
380824|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
379315|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
379316|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
379317|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
379318|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379319|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379320|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
379321|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
379322|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379323|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379324|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379325|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379326|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379327|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379328|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
379329|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
379330|NCT01041417|E2|Reported Event|Placebo|Saline injection - Monday, Wednesday and Friday for 4 weeks.
379331|NCT01041417|E1|Reported Event|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - Monday, Wednesday and Friday for 4 weeks of therapy.~500 microgram dose of GM-CSF"
379332|NCT01041404|B3|Baseline|Total|Total of all reporting groups
379333|NCT01041404|B2|Baseline|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379334|NCT01041404|B1|Baseline|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379335|NCT01041404|P2|Participant Flow|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379336|NCT01041404|P1|Participant Flow|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-fluorouracil [5-FU] or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
379337|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379338|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379339|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379340|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379516|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379341|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379342|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379343|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379344|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379345|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379346|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379347|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379348|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379349|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379350|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379351|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379352|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379353|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379354|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379355|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379356|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379357|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379358|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379359|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379360|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379361|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379362|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379363|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379364|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379365|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379366|NCT01041404|O2|Outcome|Trastuzumab, Fluoropyrimidine, Cisplatin|Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
379367|NCT01041404|O1|Outcome|Fluoropyrimidine, Cisplatin|Participants received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
379368|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379517|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379518|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379369|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379370|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379371|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379372|NCT01041404|E2|Reported Event|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
379373|NCT01041404|E1|Reported Event|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
379374|NCT01041287|B3|Baseline|Total|Total of all reporting groups
379375|NCT01041287|B2|Baseline|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for 3 months. They crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379376|NCT01041287|B1|Baseline|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for 3 months. They crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379377|NCT01041287|P2|Participant Flow|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379378|NCT01041287|P1|Participant Flow|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379379|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379380|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379381|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379382|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379519|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379520|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379383|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379384|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379385|NCT01041287|E2|Reported Event|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379386|NCT01041287|E1|Reported Event|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
379387|NCT01041209|B3|Baseline|Total|Total of all reporting groups
379388|NCT01041209|B2|Baseline|Guideline|Enforced guidelines
379389|NCT01041209|B1|Baseline|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
379390|NCT01041209|P2|Participant Flow|Guideline|Use of antibiotics according to local enforced guidelines
379391|NCT01041209|P1|Participant Flow|Bacterial Pneumonia Score (BPS)|Use of antibiotics according to Bacterial Pneumonia Score (BPS) guidance (antibiotic use when BPS > or = 4 points)
379392|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital)guidelines.
379393|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
379394|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital) guidelines
379395|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
379396|NCT01041209|E2|Reported Event|Guideline|Enforced guidelines
379397|NCT01041209|E1|Reported Event|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
379398|NCT01040871|B3|Baseline|Total|Total of all reporting groups
379399|NCT01040871|B2|Baseline|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379400|NCT01040871|B1|Baseline|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379401|NCT01040871|P2|Participant Flow|R-CHOP|R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
379402|NCT01040871|P1|Participant Flow|VR-CAP|VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
379403|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379404|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379405|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379406|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379407|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379408|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379409|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379410|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379411|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379412|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379413|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379414|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379415|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379416|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379417|NCT01040871|E2|Reported Event|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
379418|NCT01040871|E1|Reported Event|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
379419|NCT01040858|B3|Baseline|Total|Total of all reporting groups
379420|NCT01040858|B2|Baseline|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379421|NCT01040858|B1|Baseline|Cognitive Strategies Group|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
380825|NCT01037244|O4|Outcome|Placebo|Placebo tablets
379422|NCT01040858|P2|Participant Flow|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379423|NCT01040858|P1|Participant Flow|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379424|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379425|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379426|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379427|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379428|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379429|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379430|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379431|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379432|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379433|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379434|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379435|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379436|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379437|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379438|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379439|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379440|NCT01040858|O2|Outcome|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379441|NCT01040858|O1|Outcome|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379442|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379443|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379444|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379445|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379446|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379447|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379448|NCT01040858|E2|Reported Event|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
379449|NCT01040858|E1|Reported Event|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
379450|NCT01040845|B3|Baseline|Total|Total of all reporting groups
379451|NCT01040845|B2|Baseline|Oral Contraceptive With Colchicine Then Placebo|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
379452|NCT01040845|B1|Baseline|Oral Contraceptive With Placebo Then Colchicine|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
379453|NCT01040845|P2|Participant Flow|Oral Contraceptive With Colchicine Then Placebo|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (over-encapsulated colchicine tablets 0.6 mg during or matching placebo capsule during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
379454|NCT01040845|P1|Participant Flow|Oral Contraceptive With Placebo Then Colchicine|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (matching placebo capsule during the first cycle or over-encapsulated colchicine tablets 0.6 mg during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
379455|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379456|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379457|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379458|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379459|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379460|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
380826|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
379461|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379462|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379463|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379464|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379465|NCT01040845|E1|Reported Event|Oral Contraceptive With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
379466|NCT01040832|B3|Baseline|Total|Total of all reporting groups
379467|NCT01040832|B2|Baseline|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379468|NCT01040832|B1|Baseline|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379469|NCT01040832|P2|Participant Flow|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379470|NCT01040832|P1|Participant Flow|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379471|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379472|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379473|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379521|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379522|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379523|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379524|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380827|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
379474|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379475|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379476|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379477|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379478|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379479|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379480|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379481|NCT01040832|E2|Reported Event|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379482|NCT01040832|E1|Reported Event|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
379483|NCT01040819|B3|Baseline|Total|Total of all reporting groups
379484|NCT01040819|B2|Baseline|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
379485|NCT01040819|B1|Baseline|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
379486|NCT01040819|P2|Participant Flow|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
379525|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379526|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379527|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379528|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379529|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379530|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380828|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
379487|NCT01040819|P1|Participant Flow|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
379488|NCT01040819|O2|Outcome|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
379489|NCT01040819|O1|Outcome|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
379490|NCT01040819|E2|Reported Event|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
379491|NCT01040819|E1|Reported Event|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
379492|NCT01040793|B1|Baseline|Overall Study|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
379493|NCT01040793|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
379494|NCT01040793|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379495|NCT01040793|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
379496|NCT01040793|P3|Participant Flow|Olo 5mcg/ Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379497|NCT01040793|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379498|NCT01040793|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379499|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379500|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379501|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379502|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379503|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379504|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379505|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379506|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379507|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379508|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379509|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379510|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379511|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379512|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379513|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379514|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379535|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379536|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379537|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379538|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379539|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379540|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379541|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379542|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379543|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379544|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379545|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379546|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379547|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379548|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379549|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379550|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379551|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379552|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379553|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379554|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379555|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379556|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379557|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379558|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379559|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379560|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379561|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379562|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379563|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379564|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379565|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379566|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379567|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379568|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379569|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
379570|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379571|NCT01040793|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379572|NCT01040793|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379573|NCT01040793|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379574|NCT01040780|B3|Baseline|Total|Total of all reporting groups
379575|NCT01040780|B2|Baseline|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
379576|NCT01040780|B1|Baseline|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
379577|NCT01040780|P2|Participant Flow|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
379578|NCT01040780|P1|Participant Flow|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
379579|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
379580|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
379581|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
379582|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
379583|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
379584|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
379585|NCT01040780|O2|Outcome|Gefitinib|250 mg daily by mouth
379586|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
379587|NCT01040780|O2|Outcome|Gefitinib|250 mg every 24 hours by mouth
379588|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
379589|NCT01040780|E2|Reported Event|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
379590|NCT01040780|E1|Reported Event|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
379591|NCT01040728|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 122 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
379592|NCT01040728|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|"Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
379647|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379648|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379593|NCT01040728|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|"Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
379594|NCT01040728|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|"Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
379595|NCT01040728|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|"Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
379596|NCT01040728|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
379597|NCT01040728|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379598|NCT01040728|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379599|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379600|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379601|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379602|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379603|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379604|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379605|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379606|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379607|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379608|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379609|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379610|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379611|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379612|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379613|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379614|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379615|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379616|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379617|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379618|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379619|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379620|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379621|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379622|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379623|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379624|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379625|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379626|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379627|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379628|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379629|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379630|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379631|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379632|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379633|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379634|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379635|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379636|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379637|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379638|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379639|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379640|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379641|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379642|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379643|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379644|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379645|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
379646|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379649|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379650|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379651|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379652|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379653|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379654|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379655|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379656|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
379657|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379658|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379659|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
379660|NCT01040728|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
379661|NCT01040728|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379662|NCT01040728|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379663|NCT01040728|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
379664|NCT01040689|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 108 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
379665|NCT01040689|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
379666|NCT01040689|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
379667|NCT01040689|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
379668|NCT01040689|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
379669|NCT01040689|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
379670|NCT01040689|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379671|NCT01040689|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379672|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379673|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379674|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379675|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379676|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379677|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379678|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379679|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379680|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379681|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379682|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379683|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379684|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379685|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379686|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379687|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379688|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379689|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379690|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379691|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379692|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379693|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379694|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379695|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379696|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379697|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379698|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379699|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379700|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379701|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379702|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379703|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379704|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379705|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379706|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379707|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379708|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379709|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379710|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379711|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379712|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379713|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379714|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379715|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379716|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379717|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379718|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
379719|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379720|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379721|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379722|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379723|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379724|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379725|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
379726|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379727|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379728|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379729|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
379730|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379731|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379732|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379733|NCT01040689|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
379734|NCT01040689|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379735|NCT01040689|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379736|NCT01040689|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
379737|NCT01040624|B3|Baseline|Total|Total of all reporting groups
379738|NCT01040624|B2|Baseline|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
379739|NCT01040624|B1|Baseline|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
379740|NCT01040624|P2|Participant Flow|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
379741|NCT01040624|P1|Participant Flow|HR-A|"< 15% risk of + lymph nodes (LN)~< 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months."
379742|NCT01040624|O2|Outcome|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
379743|NCT01040624|O1|Outcome|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
379744|NCT01040624|E2|Reported Event|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
380829|NCT01037244|O4|Outcome|Placebo|Placebo tablets
379745|NCT01040624|E1|Reported Event|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
379746|NCT01040403|B1|Baseline|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
379747|NCT01040403|P1|Participant Flow|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
379748|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379749|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379750|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379751|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379752|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379753|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379754|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379755|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379756|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379757|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379758|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379759|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379760|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379761|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379762|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379763|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379764|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379765|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379766|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379767|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
380047|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380048|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379768|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379769|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379770|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379771|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379772|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379773|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379774|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379775|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379776|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379777|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379778|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379779|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379780|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379781|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379782|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379783|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379784|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379785|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379786|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379787|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379788|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379789|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379790|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379791|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379792|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379793|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379794|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379795|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379796|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379797|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379798|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379799|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379800|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379801|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379802|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379803|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379804|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379805|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379806|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379807|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379808|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379809|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379810|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379811|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379812|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379813|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379814|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379815|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379816|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379817|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379818|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379819|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379820|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379821|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379822|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379823|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379824|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379825|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379826|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379827|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379828|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379829|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379830|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379831|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379832|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379833|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379834|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379835|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379836|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379837|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379838|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379839|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379840|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379841|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379842|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379843|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379844|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379845|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379846|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379847|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379848|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379849|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379850|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379851|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379852|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379853|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379854|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379855|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379856|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379857|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379858|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379859|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379860|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379861|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379862|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379863|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379864|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379865|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379866|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379867|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379868|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379869|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379870|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379871|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379872|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379873|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379874|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379875|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379876|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379877|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379878|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379879|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379880|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379881|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379882|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379883|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379884|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379885|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379886|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379887|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379888|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379889|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379890|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379891|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379892|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379893|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379894|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379895|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379896|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379897|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379898|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379899|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379900|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379901|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379902|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379903|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379904|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379905|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379906|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379907|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379908|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379909|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379910|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379911|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379912|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379913|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379914|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379915|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379916|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379917|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
379918|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379919|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379920|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379921|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379922|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379923|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379924|NCT01040403|E8|Reported Event|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379925|NCT01040403|E7|Reported Event|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379926|NCT01040403|E6|Reported Event|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379927|NCT01040403|E5|Reported Event|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379928|NCT01040403|E4|Reported Event|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379929|NCT01040403|E3|Reported Event|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379930|NCT01040403|E2|Reported Event|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
379931|NCT01040403|E1|Reported Event|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
379932|NCT01040351|B3|Baseline|Total|Total of all reporting groups
379933|NCT01040351|B2|Baseline|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
379934|NCT01040351|B1|Baseline|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
379935|NCT01040351|P2|Participant Flow|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
379936|NCT01040351|P1|Participant Flow|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
379937|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
379938|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
379939|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
379940|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
379941|NCT01040351|E2|Reported Event|2. no Aspiration|IVF-ET without any prior intervention
379942|NCT01040351|E1|Reported Event|1: Hydrosalpinx Needle Aspiration|Aspiration of hydrosalpingeal fluid prior to IVF-ET
379943|NCT01040260|B3|Baseline|Total|Total of all reporting groups
379944|NCT01040260|B2|Baseline|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
379945|NCT01040260|B1|Baseline|Contingency Management|Use of tangible rewards for verified abstinence
379946|NCT01040260|P2|Participant Flow|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
379947|NCT01040260|P1|Participant Flow|Contingency Management|Use of tangible rewards for verified abstinence
379948|NCT01040260|O2|Outcome|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
379949|NCT01040260|O1|Outcome|Contingency Management|Use of tangible rewards for verified abstinence
379950|NCT01040260|E2|Reported Event|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
379951|NCT01040260|E1|Reported Event|Contingency Management|Use of tangible rewards for verified abstinence
379952|NCT01040208|B4|Baseline|Total|Total of all reporting groups
379953|NCT01040208|B3|Baseline|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
379954|NCT01040208|B2|Baseline|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
379955|NCT01040208|B1|Baseline|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
379956|NCT01040208|P3|Participant Flow|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
379957|NCT01040208|P2|Participant Flow|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
379958|NCT01040208|P1|Participant Flow|Flibanserin 50 mg to 100 mg Qhs (Take Daily, at Bedtime)|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
379959|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
379960|NCT01040208|O2|Outcome|Flibanserin 100mg Qhs|
379961|NCT01040208|O1|Outcome|Flibanserin 50mg to 100mg Qhs|Group includes the 45 patients who took flibanserin 50 mg q.h.s. for the first 2 weeks followed by flibanserin 100 mg q.h.s.
379962|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
379963|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|
379964|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|
379965|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
379966|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
379967|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
379968|NCT01040208|E3|Reported Event|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
379969|NCT01040208|E2|Reported Event|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
379970|NCT01040208|E1|Reported Event|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
379971|NCT01040169|B3|Baseline|Total|Total of all reporting groups
379972|NCT01040169|B2|Baseline|ProClude Prophylaxis Paste|
379973|NCT01040169|B1|Baseline|Nupro C Prophylaxis Paste|
379974|NCT01040169|P2|Participant Flow|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
379975|NCT01040169|P1|Participant Flow|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
379976|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
379977|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
379978|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
379979|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
379980|NCT01040169|E2|Reported Event|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
379981|NCT01040169|E1|Reported Event|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
379982|NCT01040130|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
379983|NCT01040130|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
379984|NCT01040130|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379985|NCT01040130|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
380049|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
379986|NCT01040130|P3|Participant Flow|Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379987|NCT01040130|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379988|NCT01040130|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
379989|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379990|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379991|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379992|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379993|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379994|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379995|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379996|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
379997|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
379998|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
379999|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
380000|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380001|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
380002|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
380003|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380004|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380005|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380006|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380007|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380008|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380009|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380010|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380011|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380012|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380013|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380014|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380015|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380016|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380017|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380018|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380019|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380020|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380021|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380022|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380023|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380024|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380025|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380026|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380027|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380028|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380029|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380030|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380031|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380032|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380033|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380034|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380035|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380036|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380037|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380038|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380039|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380040|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380041|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380042|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380043|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380044|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380045|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380046|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380050|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380051|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380052|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380053|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380054|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380055|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380056|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380057|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380058|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
380059|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
380060|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380061|NCT01040130|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
380062|NCT01040130|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
380063|NCT01040130|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
380064|NCT01040052|B1|Baseline|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
380065|NCT01040052|P1|Participant Flow|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
380066|NCT01040052|O1|Outcome|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
380067|NCT01040052|E1|Reported Event|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
380068|NCT01039792|B3|Baseline|Total|Total of all reporting groups
380069|NCT01039792|B2|Baseline|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
380070|NCT01039792|B1|Baseline|Placebo|"Placebo~Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
380071|NCT01039792|P2|Participant Flow|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
380072|NCT01039792|P1|Participant Flow|Placebo|"Placebo~Placebo: placebo"
380073|NCT01039792|O2|Outcome|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
380074|NCT01039792|O1|Outcome|Placebo|"Placebo~Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
380075|NCT01039792|E2|Reported Event|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
380076|NCT01039792|E1|Reported Event|Placebo|"Placebo~Placebo: placebo"
380077|NCT01039688|B4|Baseline|Total|Total of all reporting groups
380078|NCT01039688|B3|Baseline|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380079|NCT01039688|B2|Baseline|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380080|NCT01039688|B1|Baseline|CP-690,550 5 mg Twice Daily (BID)|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380081|NCT01039688|P3|Participant Flow|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380082|NCT01039688|P2|Participant Flow|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380083|NCT01039688|P1|Participant Flow|CP-690,550 5 mg Twice Daily (BID)|Participants received CP-690,550 5 milligram (mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo methotrexate (MTX) capsules, orally, once per week, for up to 24 months.
380084|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380085|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380086|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380087|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380088|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380089|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380357|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
380358|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
380090|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380091|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380092|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380093|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380094|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380095|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380096|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380097|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380098|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380099|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380100|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380101|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380102|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380103|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380104|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380105|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380106|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380107|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380108|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380109|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380110|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380111|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380112|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380113|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380830|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380114|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380115|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380116|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380117|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380118|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380119|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380120|NCT01039688|O3|Outcome|MTX 10,15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380121|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380122|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380123|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380124|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380125|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380126|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380127|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380128|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380129|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380130|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380131|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380132|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380133|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380134|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380135|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380136|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380137|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380831|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380138|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380139|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380140|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380141|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380142|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380143|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380144|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380145|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380146|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380147|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380148|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380149|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380150|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380151|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380152|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380153|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380154|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380155|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380156|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380157|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380158|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380159|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380160|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380161|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380832|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380162|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380163|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380164|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380165|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380166|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380167|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380168|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380169|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380170|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380171|NCT01039688|O3|Outcome|MTX 10, 15 or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380172|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380173|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380174|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380175|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380176|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380177|NCT01039688|O3|Outcome|MTX 10, 15 or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380178|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380179|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380180|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380181|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380182|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380183|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380184|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380185|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380833|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380186|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380187|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380188|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380189|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380190|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380191|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380192|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380193|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380194|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380195|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380196|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380197|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380198|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380199|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380200|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380201|NCT01039688|O3|Outcome|MTX 10, 15 or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380202|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380203|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380204|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380205|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380206|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380207|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380208|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380209|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380834|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380210|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380211|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380212|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380213|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380214|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380215|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380216|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380217|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380218|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380219|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380220|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380221|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380222|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380223|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380224|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380225|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380226|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380227|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380228|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380229|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380230|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380231|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380232|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380233|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380835|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380234|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380235|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380236|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380237|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380238|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380239|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380240|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380241|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380242|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380243|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380244|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380245|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380246|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380247|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380248|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380249|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380250|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380251|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380252|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380253|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380254|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380255|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380256|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380257|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380836|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380258|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380259|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380260|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380261|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380262|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380263|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380264|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380265|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380266|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380267|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380268|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380269|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380270|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380271|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380272|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380273|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380274|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380275|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380276|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380277|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380278|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380279|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380280|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380281|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380837|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380282|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380283|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380284|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380285|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380286|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380287|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380288|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380289|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380290|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380291|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380292|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380293|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380294|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380295|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380296|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380297|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380298|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380299|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380300|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380301|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380302|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380303|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380304|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380305|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380838|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380306|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380307|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380308|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380309|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380310|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380311|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380312|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380313|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380314|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380315|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380316|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380317|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380318|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380319|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380320|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380321|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380322|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380323|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380324|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380325|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380326|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380327|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380328|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380329|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380839|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380330|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380331|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380332|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380333|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380334|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380335|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380336|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380337|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380338|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380339|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380340|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380341|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380342|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380343|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380344|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380345|NCT01039688|O3|Outcome|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380346|NCT01039688|O2|Outcome|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380347|NCT01039688|O1|Outcome|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg) tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380348|NCT01039688|E3|Reported Event|MTX 10, 15, or 20 mg, Weekly|Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance.
380349|NCT01039688|E2|Reported Event|CP-690,550 10 mg BID|Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380350|NCT01039688|E1|Reported Event|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months.
380351|NCT01039675|B3|Baseline|Total|Total of all reporting groups
380352|NCT01039675|B2|Baseline|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
380353|NCT01039675|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
380354|NCT01039675|P2|Participant Flow|UMEC/VI 500/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 500/25 micrograms (µg) QD via a DPI in the morning for 4 weeks.
380355|NCT01039675|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 4 weeks.
380356|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
380840|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380359|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
380360|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
380361|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
380362|NCT01039675|E2|Reported Event|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
380363|NCT01039675|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
380364|NCT01039584|B4|Baseline|Total|Total of all reporting groups
380365|NCT01039584|B3|Baseline|Placebo|"vehicle of the test product~Placebo : vaginal cream"
380366|NCT01039584|B2|Baseline|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
380367|NCT01039584|B1|Baseline|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
380368|NCT01039584|P3|Participant Flow|Placebo|"vehicle of the test product~Placebo : vaginal cream"
380369|NCT01039584|P2|Participant Flow|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
380370|NCT01039584|P1|Participant Flow|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
380371|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
380372|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
380373|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
380374|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
380375|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
380376|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
380377|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
380378|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
380379|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
380380|NCT01039584|E3|Reported Event|Placebo|"vehicle of the test product~Placebo : vaginal cream"
380381|NCT01039584|E2|Reported Event|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
380382|NCT01039584|E1|Reported Event|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
380383|NCT01039519|B1|Baseline|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380384|NCT01039519|P1|Participant Flow|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380385|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380386|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380387|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380388|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380389|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380390|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380391|NCT01039519|E1|Reported Event|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
380392|NCT01039428|B3|Baseline|Total|Total of all reporting groups
380393|NCT01039428|B2|Baseline|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
380394|NCT01039428|B1|Baseline|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
380395|NCT01039428|P2|Participant Flow|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
380396|NCT01039428|P1|Participant Flow|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
380397|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380398|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380399|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380400|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380401|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380402|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380403|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380404|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380405|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380406|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380407|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380408|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380409|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380410|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380411|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380412|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380413|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380414|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
380415|NCT01039428|E2|Reported Event|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
380416|NCT01039428|E1|Reported Event|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
380417|NCT01039376|B3|Baseline|Total|Total of all reporting groups
380418|NCT01039376|B2|Baseline|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380419|NCT01039376|B1|Baseline|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380420|NCT01039376|P2|Participant Flow|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380421|NCT01039376|P1|Participant Flow|Ofatumumab|Participants with relapsed chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380422|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380423|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380424|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380425|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380426|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380427|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380428|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380429|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380430|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380431|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380432|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380433|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380434|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380435|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380436|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380437|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380438|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380841|NCT01037244|E4|Reported Event|Placebo|Placebo tablets
380439|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380440|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380441|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380442|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380443|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380444|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380445|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380446|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380447|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380448|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380449|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380450|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380451|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380452|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380453|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380454|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380455|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380456|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380457|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380458|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380459|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380460|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380461|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380462|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380463|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380464|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380465|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380466|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380467|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380468|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380469|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380470|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380471|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380472|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380842|NCT01037244|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
380473|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380474|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380475|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380476|NCT01039376|E2|Reported Event|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
380477|NCT01039376|E1|Reported Event|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
380478|NCT01039207|B1|Baseline|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380479|NCT01039207|P1|Participant Flow|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380480|NCT01039207|O1|Outcome|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380481|NCT01039207|O1|Outcome|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380482|NCT01039207|O1|Outcome|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380483|NCT01039207|O1|Outcome|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380484|NCT01039207|O1|Outcome|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380485|NCT01039207|E1|Reported Event|AMG 102|AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
380486|NCT01038921|B3|Baseline|Total|Total of all reporting groups
380487|NCT01038921|B2|Baseline|Placebo First|Cross-over design with subjects receiving Placebo First
380488|NCT01038921|B1|Baseline|Melatonin First|Cross-over design with subjects receiving Melatonin First
380489|NCT01038921|P2|Participant Flow|Placebo|Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second
380490|NCT01038921|P1|Participant Flow|Melatonin|Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second
380491|NCT01038921|O2|Outcome|Placebo|Cross-over design for all subjects on Placebo for 10 weeks measured at baseline and at 10 weeks.
380492|NCT01038921|O1|Outcome|Melatonin|Cross-over design for subjects on Melatonin for 10 weeks measured at baseline and 10 weeks
380493|NCT01038921|E2|Reported Event|Placebo First|Cross-over design for subjects randomized to Placebo First, Melatonin Second
380494|NCT01038921|E1|Reported Event|Melatonin First|Cross-over design for subjects randomized to Melatonin First, Placebo Second
380495|NCT01038869|B1|Baseline|Finacea|Open label pilot study
380496|NCT01038869|P1|Participant Flow|Finacea|Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
380497|NCT01038869|O1|Outcome|Azelaic Acid 15%|tolerability assessments
380498|NCT01038869|O1|Outcome|Azelaic Acid 15%|lesion counts
380499|NCT01038869|O1|Outcome|Azelaic Acid 15%|
380500|NCT01038869|O1|Outcome|Azelaic Acis 15% Open Label|Assessments of PIH IGA
380501|NCT01038869|O1|Outcome|Azelaic Acid 15% Open Label|Assessments of IGA
380502|NCT01038869|E1|Reported Event|Finacea|Open label pilot study
380503|NCT01038856|B1|Baseline|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
380504|NCT01038856|P1|Participant Flow|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
380505|NCT01038856|O1|Outcome|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
380506|NCT01038856|O1|Outcome|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
380507|NCT01038856|O1|Outcome|Erlotinib|150 mg po daily x 16 weeks
380508|NCT01038856|O1|Outcome|Single Arm Study|This was a single arm study
380509|NCT01038856|E1|Reported Event|+JAK2V61F Mutation|"Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation~Erlotinib: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib"
380510|NCT01038752|B3|Baseline|Total|Total of all reporting groups
380511|NCT01038752|B2|Baseline|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380579|NCT01038635|O1|Outcome|Phase I: 5-AZA + LEN MTD|5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
380844|NCT01037244|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
380512|NCT01038752|B1|Baseline|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380513|NCT01038752|P2|Participant Flow|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo, Docetaxel, Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380514|NCT01038752|P1|Participant Flow|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin, Docetaxel, Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380515|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380516|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380517|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380518|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380519|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380520|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380521|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380522|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380523|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380524|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380525|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380526|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380527|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380528|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380580|NCT01038635|O7|Outcome|5-AZA + 10 Days LEN 75 mg 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
380843|NCT01037244|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
380529|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380530|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380531|NCT01038752|E2|Reported Event|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380532|NCT01038752|E1|Reported Event|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
380533|NCT01038713|B4|Baseline|Total|Total of all reporting groups
380534|NCT01038713|B3|Baseline|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380535|NCT01038713|B2|Baseline|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380536|NCT01038713|B1|Baseline|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380537|NCT01038713|P3|Participant Flow|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380538|NCT01038713|P2|Participant Flow|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380539|NCT01038713|P1|Participant Flow|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380540|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380541|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380542|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380543|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380544|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380545|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380546|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380547|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380581|NCT01038635|O6|Outcome|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
380582|NCT01038635|O5|Outcome|5-AZA + 5 Days LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
380548|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380549|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380550|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380551|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380552|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380553|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380554|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380555|NCT01038713|E3|Reported Event|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380556|NCT01038713|E2|Reported Event|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380557|NCT01038713|E1|Reported Event|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
380558|NCT01038635|B10|Baseline|Total|Total of all reporting groups
380559|NCT01038635|B9|Baseline|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
380560|NCT01038635|B8|Baseline|Phase II: 5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
380561|NCT01038635|B7|Baseline|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
380562|NCT01038635|B6|Baseline|5-AZA + LEN 75 mg 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
380563|NCT01038635|B5|Baseline|5-AZA + 50 LEN|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
380564|NCT01038635|B4|Baseline|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
380565|NCT01038635|B3|Baseline|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
380566|NCT01038635|B2|Baseline|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days
380567|NCT01038635|B1|Baseline|5-AZA + LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days
380568|NCT01038635|P9|Participant Flow|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
380569|NCT01038635|P8|Participant Flow|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
380570|NCT01038635|P7|Participant Flow|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
380571|NCT01038635|P6|Participant Flow|5-AZA + LEN 75 mg for 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
380572|NCT01038635|P5|Participant Flow|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
380573|NCT01038635|P4|Participant Flow|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
380574|NCT01038635|P3|Participant Flow|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
380575|NCT01038635|P2|Participant Flow|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
380576|NCT01038635|P1|Participant Flow|5-AZA + LEN 10 mg|Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
380577|NCT01038635|O1|Outcome|Overall Study: 5-AZA + LEN MTD|Combined reporting for all phases, Phase I (5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10) and Phase II All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
380578|NCT01038635|O2|Outcome|Phase II: 5-AZA + LEN|All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg was administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
380583|NCT01038635|O4|Outcome|5-AZA + 5 Days LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
380584|NCT01038635|O3|Outcome|5-AZA + 5 Days LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
380585|NCT01038635|O2|Outcome|5-AZA + 5 Days LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
380586|NCT01038635|O1|Outcome|5-AZA + 5 Days LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
380587|NCT01038635|E9|Reported Event|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
380588|NCT01038635|E8|Reported Event|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
380589|NCT01038635|E7|Reported Event|5-AZA + 10 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
380590|NCT01038635|E6|Reported Event|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
380591|NCT01038635|E5|Reported Event|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
380592|NCT01038635|E4|Reported Event|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
380593|NCT01038635|E3|Reported Event|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
380594|NCT01038635|E2|Reported Event|5-AZA + LEN 15 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
380595|NCT01038635|E1|Reported Event|5-AZA + LEN 10 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
380596|NCT01038609|B6|Baseline|Total|Total of all reporting groups
380597|NCT01038609|B5|Baseline|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380598|NCT01038609|B4|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380599|NCT01038609|B3|Baseline|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380600|NCT01038609|B2|Baseline|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380601|NCT01038609|B1|Baseline|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380602|NCT01038609|P5|Participant Flow|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380603|NCT01038609|P4|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380604|NCT01038609|P3|Participant Flow|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380605|NCT01038609|P2|Participant Flow|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380606|NCT01038609|P1|Participant Flow|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380607|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380608|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380609|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380610|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380611|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380612|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380703|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
380704|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
380613|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380614|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380615|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380616|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380617|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380618|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380619|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380620|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380621|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380622|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380623|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380624|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380625|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380626|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380627|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380628|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380629|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380630|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380631|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380632|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380633|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380634|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380635|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380636|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380637|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380638|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380639|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380640|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380641|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380642|NCT01038609|E5|Reported Event|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380643|NCT01038609|E4|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380644|NCT01038609|E3|Reported Event|Morphine Extended Release/Acetaminophen|1 dose of 1 morphine extended release capsule and 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380645|NCT01038609|E2|Reported Event|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
380646|NCT01038609|E1|Reported Event|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
380647|NCT01038336|B4|Baseline|Total|Total of all reporting groups
380648|NCT01038336|B3|Baseline|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
380649|NCT01038336|B2|Baseline|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation brochure: The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380650|NCT01038336|B1|Baseline|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380651|NCT01038336|P3|Participant Flow|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
380652|NCT01038336|P2|Participant Flow|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380653|NCT01038336|P1|Participant Flow|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380654|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
380655|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380656|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380657|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
380658|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380659|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380660|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
380661|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380705|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
380662|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380663|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
380664|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380665|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380666|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): Soc amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
380667|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380668|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380669|NCT01038336|O3|Outcome|Standard of Care|Standard of care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to.
380670|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380671|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380672|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
380673|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380674|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380675|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
380676|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
380677|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
380678|NCT01038336|E3|Reported Event|Standard of Care|Standard of Care (SoC): SoC amounts ot no intervention although participants were allowed to seek information about hearing loss prevention if they wanted to.
380679|NCT01038336|E2|Reported Event|Hearing Conservation Brochure|Hearing Conservation Brochure (HCB). Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
380680|NCT01038336|E1|Reported Event|Multimedia Hearing Loss Prevention Program|Multimedia Hearing Loss Prevention Program (HLPP) is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
380681|NCT01038323|B4|Baseline|Total|Total of all reporting groups
380682|NCT01038323|B3|Baseline|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
380683|NCT01038323|B2|Baseline|Milnacipran|Milnacipran (drug) only
380684|NCT01038323|B1|Baseline|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
380685|NCT01038323|P3|Participant Flow|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
380686|NCT01038323|P2|Participant Flow|Milnacipran|Milnacipran (drug) only
380687|NCT01038323|P1|Participant Flow|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
380688|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
380689|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
380690|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
380691|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
380692|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
380693|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
380694|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
380695|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
380696|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
380697|NCT01038323|E3|Reported Event|Cognitive Behavioral Therapy|Cognitive behavioral therapy + placebo
380698|NCT01038323|E2|Reported Event|Milnacipran|milnacipran + education
380699|NCT01038323|E1|Reported Event|Combination|Cognitive behavioral therapy + milnacipran
380700|NCT01038128|B1|Baseline|Memantine|Memantine, 10-40 mg daily
380701|NCT01038128|P1|Participant Flow|Memantine|Memantine, 10-40 mg daily
380702|NCT01038128|O1|Outcome|Baseline Data|Ratings at Baseline and Endpoint.
380706|NCT01038128|O1|Outcome|Memantine|Number of Binge Eating and Purging Episodes at Baseline and Endpoint
380707|NCT01038128|E1|Reported Event|Memantine|Memantine, 10-40 mg daily
380708|NCT01037452|B5|Baseline|Total|Total of all reporting groups
380709|NCT01037452|B4|Baseline|Placebo|Placebo, single dose
380710|NCT01037452|B3|Baseline|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
380711|NCT01037452|B2|Baseline|PPI Alone|Lansoprazole 15 mg, single dose
380712|NCT01037452|B1|Baseline|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
380713|NCT01037452|P4|Participant Flow|Placebo|Placebo, single dose
380714|NCT01037452|P3|Participant Flow|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
380715|NCT01037452|P2|Participant Flow|PPI Alone|Lansoprazole 15 mg, single dose
380716|NCT01037452|P1|Participant Flow|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
380717|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
380718|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
380719|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
380720|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
380721|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
380722|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
380723|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
380724|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
380725|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
380726|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
380727|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
380728|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
380729|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
380730|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
380731|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
380732|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
380733|NCT01037452|E4|Reported Event|Placebo|Placebo, single dose
380734|NCT01037452|E3|Reported Event|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
380735|NCT01037452|E2|Reported Event|PPI Alone|Lansoprazole 15 mg, single dose
380736|NCT01037452|E1|Reported Event|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
380737|NCT01037309|B7|Baseline|Total|Total of all reporting groups
380738|NCT01037309|B6|Baseline|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380739|NCT01037309|B5|Baseline|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380740|NCT01037309|B4|Baseline|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380741|NCT01037309|B3|Baseline|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380742|NCT01037309|B2|Baseline|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380743|NCT01037309|B1|Baseline|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380744|NCT01037309|P9|Participant Flow|Intravenous PRO044 8 mg/kg|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380745|NCT01037309|P8|Participant Flow|Intravenous PRO044 5 mg/kg|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380746|NCT01037309|P7|Participant Flow|Intravenous PRO044 1.5 mg/kg|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380747|NCT01037309|P6|Participant Flow|Subcutaneous PRO044 12 mg/kg|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380748|NCT01037309|P5|Participant Flow|Subcutaneous PRO044 10 mg/kg|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380749|NCT01037309|P4|Participant Flow|Subcutaneous PRO044 8 mg/kg|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380750|NCT01037309|P3|Participant Flow|Subcutaneous PRO044 5 mg/kg|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380751|NCT01037309|P2|Participant Flow|Subcutaneous PRO044 1.5 mg/kg|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380752|NCT01037309|P1|Participant Flow|Subcutaneous PRO044 0.5 mg/kg|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380753|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380754|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380755|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380756|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380813|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380757|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380758|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380759|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380760|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380761|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380762|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380763|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380764|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380765|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380766|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380767|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380768|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380769|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380770|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380771|NCT01037309|E9|Reported Event|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380772|NCT01037309|E8|Reported Event|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380773|NCT01037309|E7|Reported Event|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
380774|NCT01037309|E6|Reported Event|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380775|NCT01037309|E5|Reported Event|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380776|NCT01037309|E4|Reported Event|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380777|NCT01037309|E3|Reported Event|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380778|NCT01037309|E2|Reported Event|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380779|NCT01037309|E1|Reported Event|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
380780|NCT01037244|B5|Baseline|Total|Total of all reporting groups
380781|NCT01037244|B4|Baseline|Placebo|Placebo tablets
380782|NCT01037244|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
380783|NCT01037244|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
380784|NCT01037244|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
380785|NCT01037244|P4|Participant Flow|Placebo|Placebo tablets
380786|NCT01037244|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
380787|NCT01037244|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
380788|NCT01037244|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
380789|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380790|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380791|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380792|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380793|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380794|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380795|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380796|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380797|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380798|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380799|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380800|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380801|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380802|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380803|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380804|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380805|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380806|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380807|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380808|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380809|NCT01037244|O4|Outcome|Placebo|Placebo tablets
380810|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380811|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380812|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380845|NCT01037218|B5|Baseline|Total|Total of all reporting groups
380846|NCT01037218|B4|Baseline|Placebo|Placebo tablets
380847|NCT01037218|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
380848|NCT01037218|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
380849|NCT01037218|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
380850|NCT01037218|P4|Participant Flow|Placebo|Placebo tablets
380851|NCT01037218|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
380852|NCT01037218|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
380853|NCT01037218|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
380854|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380855|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380856|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380857|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380858|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380859|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380860|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380861|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380862|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380863|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380864|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380865|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380866|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380867|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380868|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380869|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380870|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380871|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380872|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380873|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380874|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380875|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380876|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380877|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380878|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380879|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380880|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380881|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380882|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380883|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380884|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380885|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380886|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380887|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380888|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380889|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380890|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380891|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380892|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380893|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380894|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380895|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380896|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380897|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380898|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380899|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380900|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380901|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380902|NCT01037218|O4|Outcome|Placebo|Placebo tablets
380903|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
380904|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
380905|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
380906|NCT01037218|E4|Reported Event|Placebo|Placebo tablets
380907|NCT01037218|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
380908|NCT01037218|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
380909|NCT01037218|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
380910|NCT01037192|B3|Baseline|Total|Total of all reporting groups
380911|NCT01037192|B2|Baseline|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
380912|NCT01037192|B1|Baseline|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
380913|NCT01037192|P2|Participant Flow|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
380914|NCT01037192|P1|Participant Flow|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
380915|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
380916|NCT01037192|O1|Outcome|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
380917|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Vancomycin 15 mg/kg IV twice daily
380918|NCT01037192|O1|Outcome|Vancomycin Once Daily|Vancomycin 30 mg/kg IV daily
380919|NCT01037192|E2|Reported Event|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
380920|NCT01037192|E1|Reported Event|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
380921|NCT01037127|B3|Baseline|Total|Total of all reporting groups
381010|NCT01036763|E1|Reported Event|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381011|NCT01036724|B3|Baseline|Total|Total of all reporting groups
381012|NCT01036724|B2|Baseline|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
380922|NCT01037127|B2|Baseline|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380923|NCT01037127|B1|Baseline|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380924|NCT01037127|P2|Participant Flow|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380925|NCT01037127|P1|Participant Flow|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib (GSK1120212) 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380926|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380927|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380928|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380929|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
381013|NCT01036724|B1|Baseline|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
381014|NCT01036724|P2|Participant Flow|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
382836|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
380930|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380931|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380932|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380933|NCT01037127|O4|Outcome|Paticipants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380934|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380935|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380936|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380937|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380938|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380939|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380940|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
381015|NCT01036724|P1|Participant Flow|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
381016|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
381017|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
384577|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
380941|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380942|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380943|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380944|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380945|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380946|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380947|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with a positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380948|NCT01037127|O4|Outcome|Participants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with a positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380949|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with a positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380950|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis, who were previoulsy treated with standard thearpy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
380951|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis, who were previously treated with standard therapy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
381018|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
381019|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
381020|NCT01036724|E2|Reported Event|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
380952|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380953|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380954|NCT01037127|E2|Reported Event|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380955|NCT01037127|E1|Reported Event|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
380956|NCT01037114|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380957|NCT01037114|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380958|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380959|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380960|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380961|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380962|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380963|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380964|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380965|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380966|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380967|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380968|NCT01037114|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
380969|NCT01037088|B1|Baseline|All Participants|All participants who were randomized
380970|NCT01037088|P1|Participant Flow|All Participants|All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
380971|NCT01037088|O3|Outcome|Placebo Cannabis|0.00% THC by weight
380972|NCT01037088|O2|Outcome|Low Dose Cannabis|1.29% THC by weight
380973|NCT01037088|O1|Outcome|Mild Dose Cannabis|3.53% THC by weight
380974|NCT01037088|O3|Outcome|Placebo Cannabis|trace THC by weight
380975|NCT01037088|O2|Outcome|Low Dose Cannabis|1.29% THC by weight
380976|NCT01037088|O1|Outcome|Mild Dose Cannabis|3.53% THC by weight
380977|NCT01037088|E3|Reported Event|Placebo Cannabis|0% 9-delta tetrahydrocannabinol by weight
380978|NCT01037088|E2|Reported Event|Low Dose Cannabis|1.29% 9-delta tetrahydrocannabinol by weight
380979|NCT01037088|E1|Reported Event|Mild Dose Cannabis|3.53% 9-delta tetrahydrocannabinol by weight
380980|NCT01036802|B3|Baseline|Total|Total of all reporting groups
380981|NCT01036802|B2|Baseline|Placebo|Patients were randomized to placebo
380982|NCT01036802|B1|Baseline|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380983|NCT01036802|P2|Participant Flow|Placebo|Patients were randomized to placebo
380984|NCT01036802|P1|Participant Flow|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380985|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
380986|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380987|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
380988|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380989|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
380990|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380991|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
380992|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380993|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
380994|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380995|NCT01036802|O2|Outcome|Placebo|Patients were on placebo
380996|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380997|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
380998|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
380999|NCT01036802|E2|Reported Event|Placebo|Patients were randomized to placebo
381000|NCT01036802|E1|Reported Event|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
381001|NCT01036763|B1|Baseline|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381002|NCT01036763|P1|Participant Flow|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381003|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381004|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381005|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381006|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381007|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381008|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381009|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
381021|NCT01036724|E1|Reported Event|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
381022|NCT01036529|B3|Baseline|Total|Total of all reporting groups
381023|NCT01036529|B2|Baseline|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
381024|NCT01036529|B1|Baseline|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
381025|NCT01036529|P2|Participant Flow|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
381026|NCT01036529|P1|Participant Flow|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulator Intervention
381027|NCT01036529|O2|Outcome|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
381028|NCT01036529|O1|Outcome|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
381029|NCT01036529|E2|Reported Event|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
381030|NCT01036529|E1|Reported Event|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
381031|NCT01036490|B3|Baseline|Total|Total of all reporting groups
381032|NCT01036490|B2|Baseline|Control|Nutritional counseling alone
381033|NCT01036490|B1|Baseline|Exercise|12-week (3 days per week) program of aerobic and resistance training followed by 40 weeks of a home exercise program plus nutritional counseling
381034|NCT01036490|P2|Participant Flow|Control|Dietary management alone
381035|NCT01036490|P1|Participant Flow|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381036|NCT01036490|O2|Outcome|Control|Dietary management alone
381037|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381038|NCT01036490|O2|Outcome|Control|Dietary management alone
381039|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381040|NCT01036490|O2|Outcome|Control|Dietary management alone
381041|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381042|NCT01036490|O2|Outcome|Control|Dietary management alone
381043|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381044|NCT01036490|O2|Outcome|Control|Dietary management alone
381045|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381046|NCT01036490|O2|Outcome|Control|Dietary management alone
381047|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381048|NCT01036490|E2|Reported Event|Control|Dietary management alone
381049|NCT01036490|E1|Reported Event|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
381050|NCT01036438|B3|Baseline|Total|Total of all reporting groups
381051|NCT01036438|B2|Baseline|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381052|NCT01036438|B1|Baseline|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381053|NCT01036438|P2|Participant Flow|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381054|NCT01036438|P1|Participant Flow|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381055|NCT01036438|O2|Outcome|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381056|NCT01036438|O1|Outcome|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381057|NCT01036438|E2|Reported Event|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381058|NCT01036438|E1|Reported Event|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
381059|NCT01036321|B3|Baseline|Total|Total of all reporting groups
381060|NCT01036321|B2|Baseline|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381061|NCT01036321|B1|Baseline|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381062|NCT01036321|P2|Participant Flow|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381063|NCT01036321|P1|Participant Flow|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381064|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381065|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381066|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381067|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381068|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381069|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381070|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381071|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381072|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381073|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381074|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381075|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381076|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381077|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381078|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381079|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381080|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381081|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381082|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381083|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381084|NCT01036321|E2|Reported Event|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
381085|NCT01036321|E1|Reported Event|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
381086|NCT01036165|B1|Baseline|Subject Disposition|Intent-to-Treat Analysis
381087|NCT01036165|P1|Participant Flow|Subject Disposition|Intent-to-Treat Analysis
381088|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
381089|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
381090|NCT01036165|E1|Reported Event|Subject Disposition|Intent-to-Treat Analysis
381091|NCT01036022|B7|Baseline|Total|Total of all reporting groups
381092|NCT01036022|B6|Baseline|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381093|NCT01036022|B5|Baseline|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381094|NCT01036022|B4|Baseline|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381095|NCT01036022|B3|Baseline|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381096|NCT01036022|B2|Baseline|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381097|NCT01036022|B1|Baseline|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381098|NCT01036022|P6|Participant Flow|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381210|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
382391|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
381099|NCT01036022|P5|Participant Flow|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381100|NCT01036022|P4|Participant Flow|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381101|NCT01036022|P3|Participant Flow|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381102|NCT01036022|P2|Participant Flow|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381103|NCT01036022|P1|Participant Flow|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules three times a day (TID) as directed by the investigator for Week 1 to Week 6. Topical 5-aminosalicylic acid (5-ASA) preparation was used as a rescue therapy.
381104|NCT01036022|O4|Outcome|GSK1399686 300mg|Participants were administered oral dose of GSK1399686 300 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 300 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381105|NCT01036022|O3|Outcome|GSK1399686 100mg|Participants were administered oral dose of GSK1399686 100 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 100 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381106|NCT01036022|O2|Outcome|GSK1399686 30mg|Participants were administered oral dose of GSK1399686 30 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 30 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381107|NCT01036022|O1|Outcome|GSK1399686 10mg|Participants were administered oral dose of GSK1399686 10 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 10 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381108|NCT01036022|O4|Outcome|GSK1399686 300mg|Participants were administered oral dose of GSK1399686 300 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 300 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381109|NCT01036022|O3|Outcome|GSK1399686 100mg|Participants were administered oral dose of GSK1399686 100 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 100 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381110|NCT01036022|O2|Outcome|GSK1399686 30mg|Participants were administered oral dose of GSK1399686 30 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 30 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381111|NCT01036022|O1|Outcome|GSK1399686 10mg|Participants were administered oral dose of GSK1399686 10 mg QD in the morning for week 1 to week 4. Blinding was maintained by administration of matching placebo to asacol TID for week 1 to week 6 and matching placebo to GSK1399686 10 mg QD in the morning for week 5 to week 6. Topical 5-ASA preparation was used as a rescue therapy.
381112|NCT01036022|O4|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381113|NCT01036022|O3|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381114|NCT01036022|O2|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381115|NCT01036022|O1|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381116|NCT01036022|O4|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381117|NCT01036022|O3|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381118|NCT01036022|O2|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381119|NCT01036022|O1|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381120|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381121|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381122|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381123|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381124|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381125|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381126|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381127|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381287|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
382837|NCT01033032|E1|Reported Event|Dose Level 3|Includes patients treated at the MTD (Dose Level 3)
381128|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381129|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381130|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381131|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381132|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381133|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381134|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381135|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381136|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381137|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381138|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381139|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381140|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381211|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381141|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381142|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381143|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381144|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381145|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381146|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381147|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381148|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381149|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381150|NCT01036022|O4|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381151|NCT01036022|O3|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381152|NCT01036022|O2|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381153|NCT01036022|O1|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381212|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
382838|NCT01033019|B3|Baseline|Total|Total of all reporting groups
381154|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381155|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381156|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381157|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381158|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381159|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381160|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381161|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381162|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381163|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381164|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381165|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381166|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381167|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381168|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381169|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381170|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381171|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381172|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381173|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381174|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381175|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381176|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381177|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381178|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381179|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381180|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381213|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381181|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381182|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381183|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381184|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381185|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381186|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381187|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381188|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381189|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381190|NCT01036022|O6|Outcome|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381191|NCT01036022|O5|Outcome|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381192|NCT01036022|O4|Outcome|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381193|NCT01036022|O3|Outcome|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381214|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
381629|NCT01034631|B3|Baseline|Phase II: Arm B Participants|"Phase II: Arm B Participants~Everolimus only, followed by BNC105P monotherapy"
381194|NCT01036022|O2|Outcome|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381195|NCT01036022|O1|Outcome|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381196|NCT01036022|E6|Reported Event|Asacol|Participants were administered oral dose of asacol at 400 mg or 800 mg taken as 1 or 2 capsules TID as directed by the investigator, depending on the 5-ASA dose received by the participants for Week 1 to Week 6. Blinding was maintained by administration of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381197|NCT01036022|E5|Reported Event|GSK1399686 300 mg|Participants were administered oral dose of GSK1399686 300 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 300 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381198|NCT01036022|E4|Reported Event|GSK1399686 100 mg|Participants were administered oral dose of GSK1399686 100 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 100 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381199|NCT01036022|E3|Reported Event|GSK1399686 30 mg|Participants were administered oral dose of GSK1399686 30 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 30 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381200|NCT01036022|E2|Reported Event|GSK1399686 10 mg|Participants were administered oral dose of GSK1399686 10 mg capsule once daily in the morning taken immediately before or within 1 hour after a meal for Week 1 to Week 4. Blinding was maintained by administration of matching placebo to asacol taken as 1 or 2 capsules as directed by the investigator TID for Week 1 to Week 6 and matching placebo to GSK1399686 10 mg once daily taken as 1capsule immediately before or within 1 hour after a meal in the morning for Week 5 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381201|NCT01036022|E1|Reported Event|Placebo|Participants were administered oral dose of matching placebo to GSK1399686 (10 mg, 30 mg, 100 mg, 300 mg) once daily taken as 1 capsule in the morning immediately before or within 1 hour after a meal, and matching placebo to asacol taken as 1 or 2 capsules TID as directed by the investigator for Week 1 to Week 6. Topical 5-ASA preparation was used as a rescue therapy.
381202|NCT01036009|B3|Baseline|Total|Total of all reporting groups
381203|NCT01036009|B2|Baseline|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381204|NCT01036009|B1|Baseline|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
381205|NCT01036009|P2|Participant Flow|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381206|NCT01036009|P1|Participant Flow|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
381207|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381208|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381209|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381215|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381216|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
381217|NCT01036009|E2|Reported Event|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
381218|NCT01036009|E1|Reported Event|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
381219|NCT01035944|B5|Baseline|Total|Total of all reporting groups
381220|NCT01035944|B4|Baseline|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381221|NCT01035944|B3|Baseline|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381222|NCT01035944|B2|Baseline|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381223|NCT01035944|B1|Baseline|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381224|NCT01035944|P4|Participant Flow|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381225|NCT01035944|P3|Participant Flow|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381226|NCT01035944|P2|Participant Flow|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381227|NCT01035944|P1|Participant Flow|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381228|NCT01035944|O4|Outcome|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381229|NCT01035944|O3|Outcome|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381230|NCT01035944|O2|Outcome|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381231|NCT01035944|O1|Outcome|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381232|NCT01035944|E4|Reported Event|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381233|NCT01035944|E3|Reported Event|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381234|NCT01035944|E2|Reported Event|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
381235|NCT01035944|E1|Reported Event|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
381236|NCT01035905|B3|Baseline|Total|Total of all reporting groups
381237|NCT01035905|B2|Baseline|Narafilcon A|Narafilcon A contact lens
381238|NCT01035905|B1|Baseline|Nelfilcon A|Nelfilcon A contact lens
381239|NCT01035905|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
381240|NCT01035905|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
381241|NCT01035905|O2|Outcome|Narafilcon A|Narafilcon A contact lens
381242|NCT01035905|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
381243|NCT01035905|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
381244|NCT01035905|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
381245|NCT01035788|B3|Baseline|Total|Total of all reporting groups
381246|NCT01035788|B2|Baseline|Cognitive Behavioral Conjoint Therapy Communication Skills|"Psychoeducational Intervention~Psychoeducation (control): This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD."
381247|NCT01035788|B1|Baseline|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD: This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
381248|NCT01035788|P2|Participant Flow|Cognitive Behavioral Conjoint Therapy Communication Skills|Cognitive-Behavioral Conjoint Therapy (CBCT) phases 1-2 communications skills training (no PTSD psychoeducation) offered during a weekend couple retreat followed by two monthly group couple sessions for skills review.
381249|NCT01035788|P1|Participant Flow|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT) is an adaptation of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT) that offers CBCT Phases 1 and 2 plus mindfulness training in a couple weekend retreat format, followed by continued use of mindfulness skills in session and for out of session practice during one transition couple therapy session, followed by CBCT Phase 3 couple sessions.
381250|NCT01035788|O2|Outcome|Cognitive Behavioral Conjoint Therapy Communication Skills|"Cognitive-Behavioral Conjoint Therapy for PTSD - Communication Skills~This control intervention will provide communication skills training from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
381251|NCT01035788|O1|Outcome|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive Behavioral ConjointTtherapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
381252|NCT01035788|E2|Reported Event|Cognitive Behavioral Conjoint Therapy Communication Skills|"CBCT for PTSD - Communication Skills~CBCT for PTSD - Communication Skills: This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
381285|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381286|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381630|NCT01034631|B2|Baseline|Phase II: Arm A|"Phase II Participants, Arm A~Everolimus + BNC105P"
381253|NCT01035788|E1|Reported Event|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy: This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
381254|NCT01035749|B5|Baseline|Total|Total of all reporting groups
381255|NCT01035749|B4|Baseline|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381256|NCT01035749|B3|Baseline|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381257|NCT01035749|B2|Baseline|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381258|NCT01035749|B1|Baseline|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381259|NCT01035749|P4|Participant Flow|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381260|NCT01035749|P3|Participant Flow|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381261|NCT01035749|P2|Participant Flow|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381262|NCT01035749|P1|Participant Flow|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381263|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381264|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381265|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381266|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381267|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381268|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381269|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381270|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381271|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381272|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381273|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381274|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381275|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381276|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381277|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381278|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381279|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381280|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381281|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381282|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381283|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381284|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381288|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381289|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381290|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381291|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381292|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381293|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381294|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381295|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381296|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381297|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381298|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381299|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381300|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381301|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381302|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381303|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381304|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381305|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381306|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381307|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381308|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381309|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381310|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381311|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381312|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381313|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381314|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381315|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381316|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381317|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381318|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381319|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381320|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381321|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381322|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381323|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381324|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381325|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381326|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381327|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381328|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381329|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381330|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381331|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381332|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381333|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381334|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381335|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381336|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381337|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381338|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381339|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381340|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381341|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381342|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381343|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381344|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381345|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381346|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381347|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381348|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381349|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381350|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381351|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381352|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381353|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381354|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381355|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381356|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381357|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381358|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381359|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381360|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381361|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381362|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381363|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381364|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381365|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381366|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381367|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381368|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381369|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381370|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381371|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381372|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381373|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381374|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381375|NCT01035749|E4|Reported Event|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381376|NCT01035749|E3|Reported Event|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
381377|NCT01035749|E2|Reported Event|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381378|NCT01035749|E1|Reported Event|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
381379|NCT01035658|B5|Baseline|Total|Total of all reporting groups
381380|NCT01035658|B4|Baseline|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381381|NCT01035658|B3|Baseline|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381382|NCT01035658|B2|Baseline|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381383|NCT01035658|B1|Baseline|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381384|NCT01035658|P4|Participant Flow|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
384578|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
381385|NCT01035658|P3|Participant Flow|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381386|NCT01035658|P2|Participant Flow|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381387|NCT01035658|P1|Participant Flow|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381388|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381389|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381390|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381391|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381392|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381393|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381394|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381395|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381396|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381631|NCT01034631|B1|Baseline|Phase I Participants|Participants in the phase I dose escalation portion of the study.
381397|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381398|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381399|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381400|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381401|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381402|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381403|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381404|NCT01035658|O1|Outcome|Phase 1|All patients in Phase I (this section contains the Maximum Tolerated Dose)
381405|NCT01035658|E4|Reported Event|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381406|NCT01035658|E3|Reported Event|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381407|NCT01035658|E2|Reported Event|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381408|NCT01035658|E1|Reported Event|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
381409|NCT01035606|B4|Baseline|Total|Total of all reporting groups
381410|NCT01035606|B3|Baseline|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
381411|NCT01035606|B2|Baseline|Education|"brain health education~brain health education: brain health education workshops"
384579|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
381412|NCT01035606|B1|Baseline|Goal-oriented Attention Regulation Training|"training in goal-directed attention regulation~training in goal-directed attention regulation: training in goal-directed attention regulation"
381413|NCT01035606|P3|Participant Flow|Technology-assisted Goal-directed Self-Regulation Training|computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
381414|NCT01035606|P2|Participant Flow|Education|"brain health education~brain health education: brain health education workshops"
381415|NCT01035606|P1|Participant Flow|Goal-oriented Attention Regulation Training|Therapist-guided training in goal-oriented attention regulation in a group format
381416|NCT01035606|O3|Outcome|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
381417|NCT01035606|O2|Outcome|Education|"brain health education~brain health education: brain health education workshops"
381418|NCT01035606|O1|Outcome|Goal-oriented Attention Regulation Training|"Training in goal-directed attention regulation~Training in goal-directed attention regulation: training in goal-directed attention regulation"
381419|NCT01035606|O3|Outcome|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
381420|NCT01035606|O2|Outcome|Education|"brain health education~brain health education: brain health education workshops"
381421|NCT01035606|O1|Outcome|Goal-oriented Attention Regulation Training|"Training in goal-directed attention regulation~Training in goal-directed attention regulation: training in goal-directed attention regulation"
381422|NCT01035606|O3|Outcome|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
381423|NCT01035606|O2|Outcome|Education|"brain health education~brain health education: brain health education workshops"
381424|NCT01035606|O1|Outcome|Goal-oriented Attention Regulation Training|"Training in goal-directed attention regulation~Training in goal-directed attention regulation: training in goal-directed attention regulation"
381425|NCT01035606|E3|Reported Event|Technology-assisted Goal-directed Self-Regulation Training|"computer-assisted training in goal-directed attention regulation~computer-assisted training in goal-directed attention regulation: computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills"
381426|NCT01035606|E2|Reported Event|Education|"brain health education~brain health education: brain health education workshops"
381427|NCT01035606|E1|Reported Event|Goal-oriented Attention Regulation Training|"training in goal-directed attention regulation~training in goal-directed attention regulation: training in goal-directed attention regulation"
381428|NCT01035346|B3|Baseline|Total|Total of all reporting groups
381429|NCT01035346|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381430|NCT01035346|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381431|NCT01035346|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381432|NCT01035346|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
381433|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381434|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381435|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381436|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381437|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381438|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381439|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381440|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381441|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381442|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381443|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381444|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381445|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381446|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381447|NCT01035346|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
381448|NCT01035346|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
381449|NCT01035333|B1|Baseline|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
381450|NCT01035333|P1|Participant Flow|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
381451|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
381452|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
381453|NCT01035333|E1|Reported Event|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
381454|NCT01035255|B3|Baseline|Total|Total of all reporting groups
381455|NCT01035255|B2|Baseline|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381456|NCT01035255|B1|Baseline|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381457|NCT01035255|P2|Participant Flow|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381458|NCT01035255|P1|Participant Flow|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381459|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381460|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381461|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381462|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381463|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381464|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381465|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381466|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381467|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381468|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381489|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381469|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381470|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381471|NCT01035255|E2|Reported Event|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
381472|NCT01035255|E1|Reported Event|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
381473|NCT01035229|B3|Baseline|Total|Total of all reporting groups
381474|NCT01035229|B2|Baseline|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381475|NCT01035229|B1|Baseline|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381476|NCT01035229|P2|Participant Flow|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381477|NCT01035229|P1|Participant Flow|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381478|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
381479|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381480|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
381481|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381482|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381483|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381484|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381485|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381486|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381487|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381488|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381490|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381491|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381492|NCT01035229|E2|Reported Event|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
381493|NCT01035229|E1|Reported Event|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
381494|NCT01035138|B4|Baseline|Total|Total of all reporting groups
381495|NCT01035138|B3|Baseline|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381496|NCT01035138|B2|Baseline|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381497|NCT01035138|B1|Baseline|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381498|NCT01035138|P3|Participant Flow|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
381499|NCT01035138|P2|Participant Flow|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 (LY 100 mg) orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
381500|NCT01035138|P1|Participant Flow|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 milligram (mg) orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381501|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381502|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381503|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381504|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381505|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381506|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381507|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381508|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381509|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381510|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381511|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381512|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381513|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381514|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381515|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381516|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
384580|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
381517|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381518|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381519|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381520|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381521|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381522|NCT01035138|O1|Outcome|LY 140 mg|Participants received 140 mg LY450319 orally once daily up to 24 months during extension study (LFBF)
381523|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381524|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381525|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381526|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381527|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381528|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381529|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381530|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381531|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381532|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381533|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381534|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381535|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381536|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381537|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381538|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381539|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381540|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381541|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381542|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381543|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381544|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381545|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381546|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381547|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381548|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381549|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381550|NCT01035138|E3|Reported Event|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381551|NCT01035138|E2|Reported Event|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
381552|NCT01035138|E1|Reported Event|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
381553|NCT01035060|B3|Baseline|Total|Total of all reporting groups
381554|NCT01035060|B2|Baseline|Young Adults|
381555|NCT01035060|B1|Baseline|Older Adults|
381556|NCT01035060|P2|Participant Flow|Young Adults|Persons aged 18-30 years
381557|NCT01035060|P1|Participant Flow|Older Adults|Persons aged ≥ 70 years
381558|NCT01035060|O2|Outcome|Young Adults|Age 18-35 years
381559|NCT01035060|O1|Outcome|Older Adults|Age > 70 years
381560|NCT01035060|E2|Reported Event|Older Adults|
381561|NCT01035060|E1|Reported Event|Younger Adults|
381562|NCT01035047|B3|Baseline|Total|Total of all reporting groups
381563|NCT01035047|B2|Baseline|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381564|NCT01035047|B1|Baseline|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381565|NCT01035047|P2|Participant Flow|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381566|NCT01035047|P1|Participant Flow|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381567|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381568|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381569|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381570|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381571|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381572|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381573|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381574|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381575|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381576|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381577|NCT01035047|E2|Reported Event|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
381578|NCT01035047|E1|Reported Event|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
381579|NCT01034709|B3|Baseline|Total|Total of all reporting groups
381580|NCT01034709|B2|Baseline|Asymptomatic|Subjects who are serologically negative for CMV IgG
381581|NCT01034709|B1|Baseline|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
381582|NCT01034709|P2|Participant Flow|Asymptomatic|Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
381583|NCT01034709|P1|Participant Flow|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
381584|NCT01034709|O2|Outcome|Asymptomatic|Subjects who are serologically negative for CMV IgG
381585|NCT01034709|O1|Outcome|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
381586|NCT01034709|E2|Reported Event|Asymptomatic|Subjects who are serologically negative for CMV IgG
381587|NCT01034709|E1|Reported Event|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
381588|NCT01034657|B1|Baseline|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381589|NCT01034657|P3|Participant Flow|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381590|NCT01034657|P2|Participant Flow|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381591|NCT01034657|P1|Participant Flow|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381592|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381593|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381594|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381595|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381596|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381597|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381598|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381599|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381600|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381601|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381602|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381603|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381604|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381605|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
384581|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
381606|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381607|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381608|NCT01034657|O3|Outcome|Not Randomized|
381609|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381610|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381611|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381612|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381613|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381614|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381615|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381616|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381617|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381618|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381619|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381620|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381621|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381622|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381623|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381624|NCT01034657|E4|Reported Event|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
381625|NCT01034657|E3|Reported Event|LBH589 + ESA - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381626|NCT01034657|E2|Reported Event|LBH589 - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
381627|NCT01034657|E1|Reported Event|LBH589 - Core Phase|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
381628|NCT01034631|B4|Baseline|Total|Total of all reporting groups
381632|NCT01034631|P3|Participant Flow|Phase II: Arm B Participants|"Phase II: Arm B Participants~Everolimus 10mg followed by BNC105P monotherapy (16mg/m^2) following progression or intolerable toxicity on Everolimus therapy."
381633|NCT01034631|P2|Participant Flow|Phase II: Arm A|"Phase II Participants, Arm A~Everolimus 10mg + BNC105P(Phase I MTD)"
381634|NCT01034631|P1|Participant Flow|Phase I Participants|Participants in the phase I dose escalation portion of the study.
381635|NCT01034631|O1|Outcome|Phase II Participants With Sufficient Correlative Samples|A subset of Phase II Participants who had sufficient correlative samples drawn for plasma biomarker analysis.
381636|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381637|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381638|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381639|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381640|NCT01034631|O1|Outcome|Arm B Participants Who Crossed Over to BNC105P Monotherapy|After progression on everolimus, 33 participants crossed over to BNC105P monotherapy per protocol.
381641|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381642|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381643|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
381644|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
381645|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381646|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
381647|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
381648|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
381649|NCT01034631|E3|Reported Event|Phase II: Arm B Participants|Phase II: Arm B Participants
381650|NCT01034631|E2|Reported Event|Phase II: Arm A|Phase II Participants, Arm A
381651|NCT01034631|E1|Reported Event|Phase I Participants|Participants in the phase I dose escalation portion of the study.
381652|NCT01034592|B1|Baseline|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381653|NCT01034592|P1|Participant Flow|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381654|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381655|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381656|NCT01034592|O1|Outcome|Lenalidomide|"Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.~Lenalidomide: 2.5 mg/wk up to 5 mg 3x/wk"
381657|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381658|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381659|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381660|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
381661|NCT01034592|E1|Reported Event|Serious Adverse Events|Serious Adverse Events include: adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
381662|NCT01034579|B3|Baseline|Total|Total of all reporting groups
381663|NCT01034579|B2|Baseline|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381836|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381664|NCT01034579|B1|Baseline|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381665|NCT01034579|P2|Participant Flow|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381666|NCT01034579|P1|Participant Flow|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381667|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381668|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381669|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381670|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381671|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381672|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381673|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381674|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381675|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381676|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381677|NCT01034579|E2|Reported Event|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381678|NCT01034579|E1|Reported Event|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
381679|NCT01034553|B1|Baseline|All Patients|"All Patients that received oral aurora A kinase inhibitor MLN8237 and bortezomib IV are summarized in this section.~Aurora A kinase inhibitor MLN8237: Given orally"
381680|NCT01034553|P6|Participant Flow|Phase II, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381681|NCT01034553|P5|Participant Flow|Phase I, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
381682|NCT01034553|P4|Participant Flow|Phase I, Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
381683|NCT01034553|P3|Participant Flow|Phase I, Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
381684|NCT01034553|P2|Participant Flow|Phase I, Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
381685|NCT01034553|P1|Participant Flow|Phase I, Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
381686|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 and bortezomib IV. >~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381687|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381688|NCT01034553|O4|Outcome|Dose Level 3|Patients received 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
381689|NCT01034553|O3|Outcome|Dose Level 2|Patients received 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
381690|NCT01034553|O2|Outcome|Dose Level 1|Patients received 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
381691|NCT01034553|O1|Outcome|Dose Level 0|This includes patients who received 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11. As well as, patients who received 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
381692|NCT01034553|O5|Outcome|Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381693|NCT01034553|O4|Outcome|Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381694|NCT01034553|O3|Outcome|Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381695|NCT01034553|O2|Outcome|Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381696|NCT01034553|O1|Outcome|Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
381697|NCT01034553|E1|Reported Event|All Patients|bortezomib: Given IV
381698|NCT01034540|B3|Baseline|Total|Total of all reporting groups
381699|NCT01034540|B2|Baseline|Placebo/Prescription Omega-3 Acid Ethyl Esters (POM3)|Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
381700|NCT01034540|B1|Baseline|Prescription Omega-3 Acid Ethyl Esters (POM3)/Placebo|POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
381701|NCT01034540|P2|Participant Flow|Placebo/Prescription Omega-3 Acid Ethyl Esters|Placebo (corn oil 4 g/d) for the first six weeks of treatment. Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the second six weeks of treatment
381702|NCT01034540|P1|Participant Flow|Prescription Omega-3 Acid Ethyl Esters/Placebo|Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the first six weeks of treatment. Placebo (corn oil 4 g/d) for the second six weeks of treatment
381703|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
381704|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
381705|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
381706|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
381707|NCT01034540|E2|Reported Event|Placebo|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
381708|NCT01034540|E1|Reported Event|POM3|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
381709|NCT01034462|B3|Baseline|Total|Total of all reporting groups
381710|NCT01034462|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
381711|NCT01034462|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
381712|NCT01034462|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
381713|NCT01034462|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
381714|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
381715|NCT01034462|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
381716|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks
381717|NCT01034462|O1|Outcome|Placebo|"Matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo to be given orally, in capsule form, once daily, for 8 weeks."
381718|NCT01034462|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
381719|NCT01034462|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
381720|NCT01034397|B3|Baseline|Total|Total of all reporting groups
381721|NCT01034397|B2|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks.
381722|NCT01034397|B1|Baseline|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
384582|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
381723|NCT01034397|P2|Participant Flow|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of greater than or equal to [≥]20 percent [%] in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
381724|NCT01034397|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) intravenously (IV) once every 4 weeks for 24 weeks.
381725|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381726|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381727|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381728|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381729|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381730|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381731|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381732|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381733|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381734|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381735|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381736|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381737|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381738|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381739|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381740|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381741|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381742|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381743|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381744|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381745|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.
381746|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381747|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381748|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381749|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
382044|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
381750|NCT01034397|O3|Outcome|Placebo-Tocilizumab|At 12 Weeks participants who did not show an improvement of ≥20% in tender and swollen joint counts were offered a rescue therapy with open-label tocilizumab 8mg/kg every 4 weeks
381751|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of at least 20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks.
381752|NCT01034397|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks
381753|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381754|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381755|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381756|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381757|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381758|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381759|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381760|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381761|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381762|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381763|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381764|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381765|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381766|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381767|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381768|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381769|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381770|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381771|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381772|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381773|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381774|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381775|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381776|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381777|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381778|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
384583|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
381779|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381780|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381781|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381782|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381783|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381784|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381785|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381786|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381787|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381788|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381789|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381790|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381791|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381792|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381793|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381794|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381795|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381796|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381797|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381798|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381799|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for a 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381800|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381801|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381802|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381803|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381804|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381805|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381806|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381807|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
382392|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
381808|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381809|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381810|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381811|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381812|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381813|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381814|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381815|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381816|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381817|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381818|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381819|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381820|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381821|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381822|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381823|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381824|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381825|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381826|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381827|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381828|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381829|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381830|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381831|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381832|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381833|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381834|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381835|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
384584|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
381837|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381838|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381839|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381840|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381841|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381842|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381843|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381844|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381845|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381846|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381847|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381848|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381849|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381850|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381851|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381852|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381853|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381854|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381855|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381856|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381857|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381858|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381859|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381860|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381861|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
381862|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381863|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381864|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
382045|NCT01034111|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
381865|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381866|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381867|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count [TJC] and swollen joint count [SJC]) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381868|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381869|NCT01034397|E3|Reported Event|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381870|NCT01034397|E2|Reported Event|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
381871|NCT01034397|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
381872|NCT01034358|B1|Baseline|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
381873|NCT01034358|P1|Participant Flow|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
381874|NCT01034358|O1|Outcome|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
381875|NCT01034358|E1|Reported Event|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
381876|NCT01034306|B3|Baseline|Total|Total of all reporting groups
381877|NCT01034306|B2|Baseline|Placebo|MAtching placebo q12 for 12 weeks
381878|NCT01034306|B1|Baseline|CF101 1mg|CF101 1mg q12 for 12 weeks
381879|NCT01034306|P2|Participant Flow|Placebo|Matching placebo q12 for 12 weeks
381880|NCT01034306|P1|Participant Flow|CF101 1mg|CF101 1mg q12 for 12 weeks
381881|NCT01034306|O2|Outcome|Placebo|Matching placebo q12 for 12 weeks
381882|NCT01034306|O1|Outcome|CF101 1mg|CF101 1mg q12 for 12 weeks
381883|NCT01034306|E2|Reported Event|Placebo|Matching placebo q12 for 12 weeks
381884|NCT01034306|E1|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
381885|NCT01034176|B3|Baseline|Total|Total of all reporting groups
381886|NCT01034176|B2|Baseline|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
381887|NCT01034176|B1|Baseline|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
381888|NCT01034176|P2|Participant Flow|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
381889|NCT01034176|P1|Participant Flow|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
381890|NCT01034176|O2|Outcome|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
381891|NCT01034176|O1|Outcome|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
381892|NCT01034176|O2|Outcome|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
381893|NCT01034176|O1|Outcome|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
381894|NCT01034176|E2|Reported Event|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
381895|NCT01034176|E1|Reported Event|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
381896|NCT01034163|B3|Baseline|Total|Total of all reporting groups
381897|NCT01034163|B2|Baseline|Placebo|Participants received matching placebo to PAN TIW, QOW.
381898|NCT01034163|B1|Baseline|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
381899|NCT01034163|P2|Participant Flow|Placebo|Participants received matching placebo to PAN TIW, QOW.
381900|NCT01034163|P1|Participant Flow|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
381901|NCT01034163|O2|Outcome|Placebo|Participants received matching placebo to PAN TIW, QOW.
381902|NCT01034163|O1|Outcome|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
381903|NCT01034163|E2|Reported Event|Placebo|Participants received matching placebo to PAN TIW, QOW.
381904|NCT01034163|E1|Reported Event|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
381905|NCT01034137|B4|Baseline|Total|Total of all reporting groups
381906|NCT01034137|B3|Baseline|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381907|NCT01034137|B2|Baseline|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382046|NCT01033942|B4|Baseline|Total|Total of all reporting groups
382393|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
381908|NCT01034137|B1|Baseline|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381909|NCT01034137|P3|Participant Flow|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381910|NCT01034137|P2|Participant Flow|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381911|NCT01034137|P1|Participant Flow|Tocilizumab + Methotrexate|Participants received intravenous (IV) Tocilizumab (TCZ) 8 milligram (mg)/kilogram (kg) every four weeks for a maximum of 26 infusions + oral capsules of Methotrexate (MTX) 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381912|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381913|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381914|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381915|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381916|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381917|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381918|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381919|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381920|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381921|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381922|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381923|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381924|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381925|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381926|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381927|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381928|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381929|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382342|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
381930|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381931|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381932|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381933|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381934|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381935|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381936|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381937|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381938|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381939|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381940|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381941|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381942|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381943|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381944|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381945|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381946|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381947|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381948|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381949|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381950|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381951|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382343|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
386706|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
381952|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381953|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381954|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381955|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381956|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381957|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381958|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381959|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381960|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381961|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381962|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381963|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381964|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381965|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381966|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381967|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381968|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381969|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381970|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381971|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381972|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381973|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382018|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381974|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381975|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381976|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381977|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381978|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381979|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381980|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381981|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381982|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381983|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381984|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381985|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381986|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381987|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381988|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381989|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381990|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381991|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381992|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381993|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381994|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381995|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382042|NCT01034111|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
382453|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
381996|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
381997|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
381998|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
381999|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382000|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382001|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382002|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382003|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382004|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382005|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382006|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382007|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382008|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382009|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382010|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382011|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382012|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382013|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382014|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382015|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382016|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382017|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382043|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
382513|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382019|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382020|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382021|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382022|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382023|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week
382024|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382025|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382026|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382027|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382028|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382029|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382030|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382031|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382032|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382033|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382034|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382035|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382036|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382037|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382038|NCT01034137|E3|Reported Event|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
382039|NCT01034137|E2|Reported Event|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
382040|NCT01034137|E1|Reported Event|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
382041|NCT01034111|B1|Baseline|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
384585|NCT01028222|E3|Reported Event|Crossover Nilotinib Treatment|Crossover nilotinib treatment
382047|NCT01033942|B3|Baseline|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382048|NCT01033942|B2|Baseline|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382049|NCT01033942|B1|Baseline|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382050|NCT01033942|P3|Participant Flow|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382051|NCT01033942|P2|Participant Flow|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382052|NCT01033942|P1|Participant Flow|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382053|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382054|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382055|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382056|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382057|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382058|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382059|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382060|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382061|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382062|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382063|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382064|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382065|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
384586|NCT01028222|E2|Reported Event|DTIC|850 mg/m2 IV every 3 weeks
382066|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382067|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382068|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382069|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382070|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382071|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382072|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382073|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382074|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382075|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382076|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382077|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382078|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382079|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382080|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382081|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382082|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382083|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382084|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382085|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382086|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382087|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382088|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382089|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382090|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382091|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382092|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382093|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382094|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382095|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382096|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382097|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382098|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382099|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382100|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382101|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382102|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382192|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382103|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382104|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382105|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382106|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382107|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382108|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382109|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382110|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382111|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382112|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382113|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382114|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382115|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382116|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382117|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382118|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382119|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382120|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382255|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382121|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382122|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382123|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382124|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382125|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382126|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382127|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382128|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382129|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382130|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382131|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382132|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382133|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382134|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382135|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382136|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382137|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382138|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382290|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382139|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382140|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382141|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382142|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382143|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382144|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382145|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382146|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382147|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382148|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382149|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382150|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382151|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382152|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382153|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382154|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382155|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382156|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382334|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382335|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382157|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382158|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382159|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382160|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382161|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382162|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382163|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382164|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382165|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382166|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382167|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382168|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382169|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382170|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382171|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382172|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382173|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382174|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382336|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382337|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382175|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382176|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382177|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382178|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382179|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382180|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382181|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382182|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382183|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382184|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382185|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382186|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382187|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382188|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382189|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382190|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382191|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382338|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
384587|NCT01028222|E1|Reported Event|Nilotinib|400 mg twice daily
382193|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382194|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382195|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382196|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382197|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382198|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382199|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382200|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382201|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382202|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382203|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382204|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382205|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382206|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382207|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382208|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382209|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382210|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382211|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382212|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382213|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382339|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382388|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382214|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382215|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382216|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382217|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382218|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382219|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382220|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382221|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382222|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382223|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382224|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382225|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382226|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382227|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382228|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382229|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382230|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382231|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382232|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382233|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382234|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382340|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382389|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382235|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382236|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382237|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382238|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382239|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382240|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382241|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382242|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382243|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382244|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382245|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382246|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382247|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382248|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
382249|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382250|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382251|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382252|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382253|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382254|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
384588|NCT01028131|B5|Baseline|Total|Total of all reporting groups
382256|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382257|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382258|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382259|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382260|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382261|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382262|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382263|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382264|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382265|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382266|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382267|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382268|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382269|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382270|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382271|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382341|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
384642|NCT01028014|P5|Participant Flow|Cyclobenzaprine 10mg Daily|10 mg tablet, one daily for 14 days
382272|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382273|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382274|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382275|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382276|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382277|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382278|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382279|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382280|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382281|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382282|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382283|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382284|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382285|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382286|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382287|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382288|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382289|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382390|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382291|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382292|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382293|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382294|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382295|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382296|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382297|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382298|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382299|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382300|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382301|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382302|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382303|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382304|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382305|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382306|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382307|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382308|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
387367|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
382309|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382310|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382311|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382312|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382313|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382314|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382315|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382316|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382317|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382318|NCT01033942|E3|Reported Event|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382319|NCT01033942|E2|Reported Event|Placebo|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382320|NCT01033942|E1|Reported Event|FTC/TDC|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
382321|NCT01033864|B3|Baseline|Total|Total of all reporting groups
382322|NCT01033864|B2|Baseline|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382323|NCT01033864|B1|Baseline|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382324|NCT01033864|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382325|NCT01033864|P1|Participant Flow|Mycophenolate Mofetil (MMF)/Prednisone|Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1.
382326|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382327|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382328|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382329|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382330|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382331|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382332|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382333|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382344|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382345|NCT01033864|E2|Reported Event|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382346|NCT01033864|E1|Reported Event|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
382347|NCT01033851|B3|Baseline|Total|Total of all reporting groups
382348|NCT01033851|B2|Baseline|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
382349|NCT01033851|B1|Baseline|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
382350|NCT01033851|P2|Participant Flow|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
382351|NCT01033851|P1|Participant Flow|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
382352|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
382353|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
382354|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
382355|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
382356|NCT01033851|E2|Reported Event|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
382357|NCT01033851|E1|Reported Event|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
382358|NCT01033825|B8|Baseline|Total|Total of all reporting groups
382359|NCT01033825|B7|Baseline|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
382360|NCT01033825|B6|Baseline|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
382361|NCT01033825|B5|Baseline|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382362|NCT01033825|B4|Baseline|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382363|NCT01033825|B3|Baseline|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382364|NCT01033825|B2|Baseline|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382365|NCT01033825|B1|Baseline|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382366|NCT01033825|P7|Participant Flow|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
382367|NCT01033825|P6|Participant Flow|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
382368|NCT01033825|P5|Participant Flow|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382369|NCT01033825|P4|Participant Flow|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382370|NCT01033825|P3|Participant Flow|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382371|NCT01033825|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382372|NCT01033825|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382373|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382374|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382375|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382376|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382377|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382378|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382379|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382380|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382381|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382382|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382383|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382384|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382385|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382386|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382387|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382394|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382395|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382396|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382397|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382398|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382399|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382400|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382401|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382402|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382403|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382404|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382405|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382406|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382407|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382408|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382409|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382410|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382411|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382412|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382413|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382414|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382415|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382416|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382417|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382418|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382419|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382420|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382421|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382422|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382423|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382424|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382425|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382426|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382427|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382428|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382429|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382430|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382431|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382432|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382433|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382434|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382435|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382436|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
382437|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
382438|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382439|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382440|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
382441|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382442|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382443|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382444|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382445|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382446|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382447|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382448|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382449|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382450|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382451|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382452|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382454|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382455|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382456|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382457|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382458|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382459|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382460|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382461|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382462|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382463|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382464|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382465|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382466|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382467|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382468|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382469|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382470|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382471|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382472|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382473|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382474|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382475|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382476|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382477|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382478|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382479|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382480|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382481|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382482|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382483|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382484|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382485|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382486|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382487|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382488|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382489|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382490|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382491|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382492|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382493|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382494|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382495|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382496|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382497|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382498|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382499|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382500|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382501|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382502|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382503|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382504|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382505|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382506|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382507|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382508|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382509|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382510|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382511|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382512|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382514|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382515|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382516|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382517|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382518|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382519|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382520|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382521|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382522|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382523|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382524|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382525|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382526|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382527|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382528|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382529|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382530|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382531|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382532|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382533|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382534|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382535|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382536|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
382537|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
382538|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382539|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382540|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382541|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382542|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382543|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
382544|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
382545|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382546|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382547|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382548|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382549|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382550|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382551|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382552|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382553|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382554|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382555|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382556|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382557|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382558|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382559|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382560|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382561|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382562|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382563|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382564|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382565|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382566|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382567|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382568|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382569|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382570|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382571|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382572|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382573|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382574|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382575|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
382576|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382577|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382578|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382579|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382580|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
382581|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
382582|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382583|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382584|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
382585|NCT01033825|E5|Reported Event|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
382586|NCT01033825|E4|Reported Event|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
382587|NCT01033825|E3|Reported Event|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
382588|NCT01033825|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
382589|NCT01033825|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
382590|NCT01033747|B3|Baseline|Total|Total of all reporting groups
382591|NCT01033747|B2|Baseline|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
382592|NCT01033747|B1|Baseline|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
382593|NCT01033747|P2|Participant Flow|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
382594|NCT01033747|P1|Participant Flow|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
382595|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
382596|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
382597|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
382598|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
382599|NCT01033747|E2|Reported Event|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study.
382600|NCT01033747|E1|Reported Event|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study
382601|NCT01033734|B1|Baseline|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight ≤23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382602|NCT01033734|P1|Participant Flow|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to (≤) 23 kilogram (kg) received 3 milligrams per kilogram (mg/kg); participants with body weight more than (>) 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 milligrams (mg). For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
384643|NCT01028014|P4|Participant Flow|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
382603|NCT01033734|O4|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382604|NCT01033734|O3|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382605|NCT01033734|O2|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382606|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382607|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382608|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382609|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382610|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382611|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382612|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382613|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
384644|NCT01028014|P3|Participant Flow|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
382614|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382615|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382616|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382617|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382618|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382619|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382620|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382621|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382622|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382623|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382688|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382689|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382624|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382625|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382626|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382627|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382628|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382629|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382630|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382631|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382632|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382633|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382690|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382691|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382634|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382635|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382636|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382637|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382638|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382639|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382640|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382641|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382642|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382643|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382692|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382693|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382644|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382645|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382646|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382647|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382648|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382649|NCT01033734|E4|Reported Event|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382650|NCT01033734|E3|Reported Event|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382651|NCT01033734|E2|Reported Event|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382652|NCT01033734|E1|Reported Event|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
382653|NCT01033565|B1|Baseline|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
382654|NCT01033565|P1|Participant Flow|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
382655|NCT01033565|O1|Outcome|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
382656|NCT01033565|E1|Reported Event|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
382694|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
384645|NCT01028014|P2|Participant Flow|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
382657|NCT01033487|B1|Baseline|Entire Study Population|Includes all participants randomized to receive PBO Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 180 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 580 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 1450 mcg dry powder first, Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first.
382658|NCT01033487|P10|Participant Flow|PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
382659|NCT01033487|P9|Participant Flow|PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
382660|NCT01033487|P8|Participant Flow|PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
382661|NCT01033487|P7|Participant Flow|Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
382662|NCT01033487|P6|Participant Flow|PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva (tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium)18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated byat least 7 days.
382663|NCT01033487|P5|Participant Flow|Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
382695|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382696|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382697|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382698|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382699|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382664|NCT01033487|P4|Participant Flow|PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period,single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(Tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
382665|NCT01033487|P3|Participant Flow|PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
382666|NCT01033487|P2|Participant Flow|PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period,single oral inhalation dose of placebo matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
382667|NCT01033487|P1|Participant Flow|PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450|Single oral inhalation dose of placebo (PBO) matched with Spiriva(tiotropium) 18 microgram (mcg) capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
382668|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
382669|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
382670|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382671|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382672|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382673|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
382674|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
382675|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382676|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382677|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382678|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
382679|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
382680|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382681|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382682|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382683|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
382684|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
382685|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382686|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382687|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
387368|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
382700|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382701|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382702|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382703|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382704|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382705|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382706|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382707|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382708|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382709|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382710|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
382711|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
382712|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382713|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382714|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382715|NCT01033487|E5|Reported Event|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
382716|NCT01033487|E4|Reported Event|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
382717|NCT01033487|E3|Reported Event|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
382718|NCT01033487|E2|Reported Event|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
382719|NCT01033487|E1|Reported Event|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
382720|NCT01033448|B1|Baseline|Pegylated Interferon (Peginterferon) Alfa-2a|Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks
382721|NCT01033448|P1|Participant Flow|Pegylated Interferon (Peginterferon) Alfa-2a|Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks
382722|NCT01033448|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa2a|Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks.
382723|NCT01033448|O1|Outcome|CHC Genotype 2 and 3|Participants received peginterferon alfa-2a 180 mcg in 0.5 mL solution administered SC once weekly plus ribavirin 800 mg orally in split doses in the morning and in the evening for 24 weeks.
382724|NCT01033448|O1|Outcome|CHC Genotype 1|Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
382725|NCT01033448|O1|Outcome|CHC Genotype 2 and 3|Participants received peginterferon alfa-2a 180 mcg in 0.5 mL solution administered SC once weekly plus ribavirin 800 mg orally in split doses in the morning and in the evening for 24 weeks.
382726|NCT01033448|O1|Outcome|CHC Genotype 1|Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
382727|NCT01033448|E1|Reported Event|Pegylated Interferon Alfa2a (Peginterferon)|Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks.
382728|NCT01033383|B5|Baseline|Total|Total of all reporting groups
382729|NCT01033383|B4|Baseline|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
382730|NCT01033383|B3|Baseline|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
382731|NCT01033383|B2|Baseline|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
382732|NCT01033383|B1|Baseline|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
382733|NCT01033383|P4|Participant Flow|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
382734|NCT01033383|P3|Participant Flow|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
382735|NCT01033383|P2|Participant Flow|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
382736|NCT01033383|P1|Participant Flow|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
382737|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
382738|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
382739|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
382740|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
382741|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
382742|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
382743|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
382744|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
382745|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
382746|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
382747|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
382748|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
382749|NCT01033383|E4|Reported Event|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
382750|NCT01033383|E3|Reported Event|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
382751|NCT01033383|E2|Reported Event|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
382752|NCT01033383|E1|Reported Event|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
382753|NCT01033227|B3|Baseline|Total|Total of all reporting groups
382754|NCT01033227|B2|Baseline|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
382755|NCT01033227|B1|Baseline|No Drug|
382756|NCT01033227|P2|Participant Flow|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
382757|NCT01033227|P1|Participant Flow|No Drug|This group did not receive anything additional in the no drug arm. The treatment group received the study drug and the non treatment group received no drug.
382758|NCT01033227|O2|Outcome|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
382759|NCT01033227|O1|Outcome|No Drug|No study drug administered
382760|NCT01033227|O2|Outcome|Sodium Nitrite Injection, USP|Administration of sodium nitrite injection, USP
382761|NCT01033227|O1|Outcome|No Drug|Will not receive study drug, there is no placebo in this study. The patient will know they are not receiving the study drug.
382762|NCT01033227|E2|Reported Event|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
382763|NCT01033227|E1|Reported Event|No Drug|This group received no study drug and no placebo. They received standard of care treatment.
382764|NCT01033071|B4|Baseline|Total|Total of all reporting groups
382765|NCT01033071|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382766|NCT01033071|B2|Baseline|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382767|NCT01033071|B1|Baseline|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382768|NCT01033071|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382769|NCT01033071|P2|Participant Flow|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382770|NCT01033071|P1|Participant Flow|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382771|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382772|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382773|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382774|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382775|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382776|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382777|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382778|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382779|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382829|NCT01033032|P4|Participant Flow|Dose Level 4|Amrubicin - 120 mg/m^2 every 21 days
387371|NCT01020981|B3|Baseline|Total|Total of all reporting groups
382780|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382781|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382782|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382783|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382784|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382785|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382786|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382787|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382788|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382789|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382790|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382791|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382830|NCT01033032|P3|Participant Flow|Dose Level 3|Amrubicin - 110 mg/m^2 IV every 21 days
382831|NCT01033032|P2|Participant Flow|Dose Level 2|Amrubicin - 100 mg/m^2 IV every 21 days
382792|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382793|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382794|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382795|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382796|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382797|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382798|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382799|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382800|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382801|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382802|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382803|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382832|NCT01033032|P1|Participant Flow|Dose Level 1|Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days
382833|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
382804|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382805|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382806|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382807|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382808|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382809|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382810|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382811|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382812|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382813|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382814|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382815|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382834|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
382835|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
382816|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382817|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382818|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382819|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382820|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382821|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382822|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382823|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382824|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382825|NCT01033071|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
382826|NCT01033071|E2|Reported Event|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382827|NCT01033071|E1|Reported Event|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
382828|NCT01033032|B1|Baseline|All Patients|Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)
382839|NCT01033019|B2|Baseline|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
382840|NCT01033019|B1|Baseline|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
382841|NCT01033019|P2|Participant Flow|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
382842|NCT01033019|P1|Participant Flow|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
382843|NCT01033019|O2|Outcome|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
382844|NCT01033019|O1|Outcome|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
382845|NCT01033019|E3|Reported Event|LDE225 0.75% - nBCC|
382846|NCT01033019|E2|Reported Event|Vehicle - sBCC|Participants topically applied matching placebo cream twice daily for 6 weeks.
382847|NCT01033019|E1|Reported Event|LDE225 0.75% - sBCC|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
382848|NCT01032993|B3|Baseline|Total|Total of all reporting groups
382849|NCT01032993|B2|Baseline|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
382850|NCT01032993|B1|Baseline|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
382851|NCT01032993|P2|Participant Flow|Placebo|The Placebo arm used placebo wafers taken as three wafers two times daily for 4 weeks. Placebo wafers contained the same excipients as the active wafers, but contained no active CoQ10. The wafers looked and tasted identical to active agent, and were manufactured by the same manufacturer of the active agent, Tishcon Corp (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
382852|NCT01032993|P1|Participant Flow|Coenzyme Q10|The Coenzyme Q10 arm used 600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily for 4 weeks. Active study wafers were ChewQ (ubidecarenone) and were manufactured by Tishcon Corp, (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
382853|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
382854|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
382855|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
382856|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
382857|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
382858|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
382859|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
382860|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
382861|NCT01032993|E2|Reported Event|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
382862|NCT01032993|E1|Reported Event|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
382863|NCT01032928|B1|Baseline|Respiratory-Swallow Phase Training|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
382864|NCT01032928|P1|Participant Flow|Respiratory - Swallow Phase Training|Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
382865|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were reassessed at one month post treatment
382866|NCT01032928|O2|Outcome|One Week Post-intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
382867|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
382868|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
382869|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
382870|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
382871|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
382872|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
382873|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
382874|NCT01032928|E1|Reported Event|Arm 1|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
382875|NCT01032915|B5|Baseline|Total|Total of all reporting groups
382876|NCT01032915|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
382877|NCT01032915|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
382878|NCT01032915|B2|Baseline|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
382879|NCT01032915|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
382880|NCT01032915|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
382881|NCT01032915|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
382882|NCT01032915|P2|Participant Flow|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
382883|NCT01032915|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
382884|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
382885|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
384776|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
382886|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
382887|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
382888|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
382889|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
382890|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
382891|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
382892|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
382893|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
382894|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
382895|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
382896|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
382897|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
382898|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
382899|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
382900|NCT01032915|E4|Reported Event|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
382901|NCT01032915|E3|Reported Event|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
382902|NCT01032915|E2|Reported Event|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
382903|NCT01032915|E1|Reported Event|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
382904|NCT01032889|B4|Baseline|Total|Total of all reporting groups
382905|NCT01032889|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382906|NCT01032889|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382907|NCT01032889|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382908|NCT01032889|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382909|NCT01032889|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382910|NCT01032889|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382911|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382912|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382913|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382914|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382915|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382916|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382917|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382918|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382919|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382920|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382921|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382922|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382923|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
383039|NCT01032694|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
382924|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382925|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382926|NCT01032889|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382927|NCT01032889|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382928|NCT01032889|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
382929|NCT01032850|B1|Baseline|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
382930|NCT01032850|P1|Participant Flow|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
382931|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
382932|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
382933|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
382934|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
382935|NCT01032850|E1|Reported Event|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
382936|NCT01032837|B5|Baseline|Total|Total of all reporting groups
382937|NCT01032837|B4|Baseline|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382938|NCT01032837|B3|Baseline|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382939|NCT01032837|B2|Baseline|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382940|NCT01032837|B1|Baseline|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382941|NCT01032837|P4|Participant Flow|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382942|NCT01032837|P3|Participant Flow|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382943|NCT01032837|P2|Participant Flow|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382965|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382944|NCT01032837|P1|Participant Flow|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382945|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382946|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382947|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382948|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382949|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382950|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382951|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382952|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382953|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382954|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382955|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382956|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382957|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382958|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382959|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382960|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382961|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382962|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382963|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382964|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382966|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382967|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382968|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382969|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382970|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382971|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382972|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382973|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382974|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382975|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382976|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382977|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382978|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382979|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382980|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382981|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382982|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382983|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382984|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382985|NCT01032837|E4|Reported Event|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
382986|NCT01032837|E3|Reported Event|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382987|NCT01032837|E2|Reported Event|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
382988|NCT01032837|E1|Reported Event|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
382989|NCT01032759|B3|Baseline|Total|Total of all reporting groups
382990|NCT01032759|B2|Baseline|Placebo|"Placebo~Placebo: BID"
382991|NCT01032759|B1|Baseline|Memantine|Memantine: 20 mg, BID
382992|NCT01032759|P2|Participant Flow|Placebo|"Placebo~Placebo: BID"
382993|NCT01032759|P1|Participant Flow|Memantine|Memantine: 20 mg, BID
382994|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
382995|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
382996|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
382997|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
382998|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
382999|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
383000|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
383001|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
383002|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
383003|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
383004|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
383005|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
383006|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
383007|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
383008|NCT01032759|E2|Reported Event|Placebo|"Placebo~Placebo: BID"
383009|NCT01032759|E1|Reported Event|Memantine|Memantine: 20 mg, BID
383010|NCT01032733|B3|Baseline|Total|Total of all reporting groups
383011|NCT01032733|B2|Baseline|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383012|NCT01032733|B1|Baseline|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
383013|NCT01032733|P2|Participant Flow|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383014|NCT01032733|P1|Participant Flow|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
383015|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383016|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
383017|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383018|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
383019|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383020|NCT01032733|O1|Outcome|Lifestyle Counseling|
383021|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383022|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
383023|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383024|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
383025|NCT01032733|E2|Reported Event|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
383026|NCT01032733|E1|Reported Event|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
383027|NCT01032694|B3|Baseline|Total|Total of all reporting groups
383028|NCT01032694|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383029|NCT01032694|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383030|NCT01032694|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383031|NCT01032694|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383032|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383033|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383034|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383035|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383036|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383037|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383038|NCT01032694|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
384777|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
383040|NCT01032538|B1|Baseline|Patients With Knee Osteoarthritis|Patients eglible for medial unicompartmental knee replacement
383041|NCT01032538|P1|Participant Flow|Patients With Knee Osteoarthritis|Patients eglible for unicondylar knee replacement
383042|NCT01032538|O1|Outcome|Passive ROM 2 Years|Range of motion measured by physiotherapist
383043|NCT01032538|O2|Outcome|KOOS ADL 2 Years|Activities of dayly living score
383044|NCT01032538|O1|Outcome|KOOS Pain 2 Years|Knee pain score, one of 5 subscores of KOOS
383045|NCT01032538|E1|Reported Event|Patients With Knee Osteoarthritis|Patients eglible for unicompartmental knee replacement
383046|NCT01032382|B3|Baseline|Total|Total of all reporting groups
383047|NCT01032382|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383048|NCT01032382|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383049|NCT01032382|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383050|NCT01032382|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383051|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383052|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383053|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383054|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383055|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383056|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383057|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383058|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383059|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383060|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383061|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383062|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383063|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383064|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383065|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383066|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383067|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383068|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383069|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383070|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383071|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383072|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383073|NCT01032382|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
383074|NCT01032382|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
383075|NCT01032291|B4|Baseline|Total|Total of all reporting groups
383076|NCT01032291|B3|Baseline|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383077|NCT01032291|B2|Baseline|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383078|NCT01032291|B1|Baseline|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383079|NCT01032291|P3|Participant Flow|Lenalidomide + Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383080|NCT01032291|P2|Participant Flow|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383081|NCT01032291|P1|Participant Flow|Lenalidomide + Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383082|NCT01032291|O2|Outcome|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383083|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383084|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383085|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383086|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383087|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383088|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383089|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383090|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383091|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383092|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383093|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383094|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383095|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383096|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383097|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383098|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383099|NCT01032291|O2|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383100|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383101|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383102|NCT01032291|E2|Reported Event|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
383103|NCT01032291|E1|Reported Event|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
383104|NCT01032265|B3|Baseline|Total|Total of all reporting groups
383105|NCT01032265|B2|Baseline|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383106|NCT01032265|B1|Baseline|Postal Treatment|Information (including life style), and PFMT exercises.
383107|NCT01032265|P2|Participant Flow|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383108|NCT01032265|P1|Participant Flow|Postal Treatment|Information (including life style), and PFMT exercises.
383109|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383110|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
383111|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383112|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
383113|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383114|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
383115|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383116|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
383117|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383118|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
383119|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383120|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
383121|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383122|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
383123|NCT01032265|E2|Reported Event|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
383124|NCT01032265|E1|Reported Event|Postal Treatment|Information (including life style), and PFMT exercises.
383125|NCT01032239|B3|Baseline|Total|Total of all reporting groups
383126|NCT01032239|B2|Baseline|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383127|NCT01032239|B1|Baseline|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383128|NCT01032239|P2|Participant Flow|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication
383129|NCT01032239|P1|Participant Flow|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383130|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383131|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383132|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383133|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383134|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383135|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383136|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383137|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383138|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383139|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383140|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383141|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383142|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383143|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383144|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383145|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383146|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383147|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383148|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383149|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383150|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383151|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383152|NCT01032239|O2|Outcome|Best Medical Treatment (BMT)|Use one or a combination oral antispastic medication.
383153|NCT01032239|O1|Outcome|ITB Therapy|Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
383154|NCT01032239|E2|Reported Event|BMT+ITB-NI|Patients randomized to BMT plus patients randomized to ITB but not implanted (treated with one or a combination oral antispastic medication)
383155|NCT01032239|E1|Reported Event|ITB-I|Patients implanted with intrathecal baclofen pump
383156|NCT01032200|B3|Baseline|Total|Total of all reporting groups
383157|NCT01032200|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383158|NCT01032200|B1|Baseline|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
384778|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
383159|NCT01032200|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383160|NCT01032200|P1|Participant Flow|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
383161|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383162|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
383163|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383164|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
383165|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383166|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
383167|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383168|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
383169|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383170|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
383171|NCT01032200|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
383172|NCT01032200|E1|Reported Event|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
383173|NCT01032174|B3|Baseline|Total|Total of all reporting groups
383174|NCT01032174|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383175|NCT01032174|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383176|NCT01032174|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383177|NCT01032174|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383178|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383179|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383180|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383181|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383182|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383183|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383184|NCT01032174|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
383185|NCT01032174|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
383186|NCT01032135|B6|Baseline|Total|Total of all reporting groups
383187|NCT01032135|B5|Baseline|MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP.~Motivational Interviewing: 2 sessions at week 2."
383188|NCT01032135|B4|Baseline|MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383189|NCT01032135|B3|Baseline|MI-IOP Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP.~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383190|NCT01032135|B2|Baseline|MI-PC Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized to receive patient choice.~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
384779|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
383191|NCT01032135|B1|Baseline|Engaged|Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention.
383192|NCT01032135|P7|Participant Flow|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383193|NCT01032135|P6|Participant Flow|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383194|NCT01032135|P5|Participant Flow|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383195|NCT01032135|P4|Participant Flow|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383196|NCT01032135|P3|Participant Flow|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383197|NCT01032135|P2|Participant Flow|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383198|NCT01032135|P1|Participant Flow|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383199|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383200|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383201|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383202|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383203|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383204|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383205|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383206|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383207|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383208|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383209|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383210|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383424|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383425|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383211|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383212|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383213|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383214|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383215|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383216|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383217|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383218|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383219|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383220|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383221|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383222|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383223|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383224|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383225|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383226|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383227|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383228|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383229|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383230|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383231|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383232|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383233|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383234|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383235|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383236|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383237|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383238|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383239|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383240|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383241|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383242|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383243|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383244|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383245|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383246|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383247|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383248|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383249|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383250|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383251|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383252|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383253|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383254|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383255|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383256|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383257|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383258|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383259|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383260|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383261|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383262|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383263|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383264|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383265|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383266|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383267|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383268|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383269|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383270|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383271|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383272|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383273|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383274|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383275|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383276|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383277|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383278|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383279|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383280|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383281|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383282|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383283|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383284|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383285|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383286|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383287|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383288|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383289|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383290|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383291|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383292|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383293|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383294|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383295|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383296|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383297|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383298|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383299|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383300|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383301|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383302|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383303|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383304|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383305|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383306|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383307|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383308|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383309|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383310|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383311|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383312|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383313|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383314|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383315|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383316|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383317|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383318|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383319|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383320|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383321|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383322|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383323|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383324|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383325|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383326|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383327|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383328|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383329|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383330|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383331|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383332|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383333|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383334|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383335|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383336|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383337|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383338|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383339|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383340|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383341|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383342|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383343|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383344|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383345|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383346|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383347|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383348|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383349|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383350|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383351|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383352|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383353|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383354|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383355|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383356|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383357|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383358|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383359|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383360|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383361|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383362|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383363|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383364|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383365|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383366|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383367|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383368|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383369|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383370|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383371|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383372|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383373|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383374|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383375|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383376|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383377|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383378|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383379|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383380|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383381|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383382|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383383|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383384|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383385|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383386|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383387|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383388|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383389|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383390|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383391|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383392|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383393|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383394|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383395|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383396|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383397|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383398|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383399|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383400|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383401|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383402|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
383403|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383404|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
383405|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
383406|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383407|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383408|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
383409|NCT01032135|E5|Reported Event|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become non-engaged in weeks 3 - 8.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2"
383410|NCT01032135|E4|Reported Event|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Participants start at IOP, Engaged at 2 weeks but disengage between 3 - 8 weeks.~Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383411|NCT01032135|E3|Reported Event|MI-IOP Non-Engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
383412|NCT01032135|E2|Reported Event|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.~Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
383413|NCT01032135|E1|Reported Event|Engaged|Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.
383414|NCT01032070|B3|Baseline|Total|Total of all reporting groups
383415|NCT01032070|B2|Baseline|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383416|NCT01032070|B1|Baseline|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383417|NCT01032070|P2|Participant Flow|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383418|NCT01032070|P1|Participant Flow|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383419|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383420|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383421|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383422|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383423|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383426|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383427|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383428|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383429|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383430|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383431|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383432|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383433|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383434|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383435|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383436|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383437|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383438|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383439|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383440|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383441|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383442|NCT01032070|E2|Reported Event|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383443|NCT01032070|E1|Reported Event|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
383444|NCT01032044|B3|Baseline|Total|Total of all reporting groups
383445|NCT01032044|B2|Baseline|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
383446|NCT01032044|B1|Baseline|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
383447|NCT01032044|P2|Participant Flow|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
383448|NCT01032044|P1|Participant Flow|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
383449|NCT01032044|O2|Outcome|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
383450|NCT01032044|O1|Outcome|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
383451|NCT01032044|E2|Reported Event|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
387571|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
383452|NCT01032044|E1|Reported Event|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
383453|NCT01032018|B3|Baseline|Total|Total of all reporting groups
383454|NCT01032018|B2|Baseline|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
383455|NCT01032018|B1|Baseline|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
383456|NCT01032018|P2|Participant Flow|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
383457|NCT01032018|P1|Participant Flow|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
383458|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
383459|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
383460|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
383461|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
383462|NCT01032018|E2|Reported Event|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
383463|NCT01032018|E1|Reported Event|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
383464|NCT01031979|B3|Baseline|Total|Total of all reporting groups
383465|NCT01031979|B2|Baseline|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
383466|NCT01031979|B1|Baseline|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
383467|NCT01031979|P2|Participant Flow|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
383468|NCT01031979|P1|Participant Flow|Yohimbime Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
383469|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
383470|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
383471|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
383472|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
383473|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
383474|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
383475|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
383476|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
383477|NCT01031979|E2|Reported Event|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
383478|NCT01031979|E1|Reported Event|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
383479|NCT01031953|B1|Baseline|Fosaprepitant|
383480|NCT01031953|P1|Participant Flow|Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
383481|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Only those in the study arm above that self report headache, dizziness, or pain/soreness at the infusion site are considered in this outcome
383482|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|participants with self report fatigue or sedation after receiving fosaprepitant
392206|NCT01011335|O11|Outcome|rLukS 25 µg|
383483|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Number of participants achieving a Complete Response (CR) up to 24 hours after receiving fosaprepitant
383484|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|This arm includes only those participants that required the use of second rescue drug after receiving Fosaprepitant
383485|NCT01031953|O1|Outcome|Participants Who Recieved Fosaprepitant|Number of participants who experienced vomiting episodes from baseline to 24 hours after receiving Fosaprepitant
383486|NCT01031953|O1|Outcome|Change in Nausea Score From 2 Hours to 12 and 24 Hours|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
383487|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
383488|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
383489|NCT01031953|E1|Reported Event|Fosaprepitant|
383490|NCT01031914|B1|Baseline|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
383491|NCT01031914|P1|Participant Flow|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have obstructive sleep apnea (OSA) and will be current CPAP users.
383492|NCT01031914|O1|Outcome|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
383493|NCT01031914|E1|Reported Event|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
383494|NCT01031810|B1|Baseline|Tranylcypromine|patients will receive treatment with tranylcypromine
383495|NCT01031810|P1|Participant Flow|Tranylcypromine|Patients will receive treatment with tranylcypromine tablets taken orally on a twice daily schedule. Dosage was initially 10 mg daily and was increased weekly up to 120 mg daily.
383496|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
383497|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
383498|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
383499|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
383500|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: monoamine oxidase inhibitor (MAOI) 60mg-120mg"
383501|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
383502|NCT01031810|E1|Reported Event|Tranylcypromine|patients will receive treatment with tranylcypromine
383503|NCT01031706|B3|Baseline|Total|Total of all reporting groups
383504|NCT01031706|B2|Baseline|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
383505|NCT01031706|B1|Baseline|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
383506|NCT01031706|P2|Participant Flow|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
383507|NCT01031706|P1|Participant Flow|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
383508|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
383509|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
383510|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
383511|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
383512|NCT01031706|E2|Reported Event|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
383513|NCT01031706|E1|Reported Event|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
383514|NCT01031680|B3|Baseline|Total|Total of all reporting groups
383515|NCT01031680|B2|Baseline|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383516|NCT01031680|B1|Baseline|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383517|NCT01031680|P2|Participant Flow|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383518|NCT01031680|P1|Participant Flow|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383519|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383520|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383521|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383522|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383523|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383524|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383525|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383526|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383527|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383528|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383529|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383530|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383531|NCT01031680|E2|Reported Event|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
383532|NCT01031680|E1|Reported Event|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
383533|NCT01031628|B5|Baseline|Total|Total of all reporting groups
383534|NCT01031628|B4|Baseline|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383535|NCT01031628|B3|Baseline|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383536|NCT01031628|B2|Baseline|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383537|NCT01031628|B1|Baseline|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383538|NCT01031628|P4|Participant Flow|400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383539|NCT01031628|P3|Participant Flow|400 mg for Patients With Imatinib Blood Levels ≥ 1100|"Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383540|NCT01031628|P2|Participant Flow|600 or 800 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383541|NCT01031628|P1|Participant Flow|400 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383542|NCT01031628|O4|Outcome|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383543|NCT01031628|O3|Outcome|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383544|NCT01031628|O2|Outcome|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383545|NCT01031628|O1|Outcome|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383546|NCT01031628|E4|Reported Event|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383547|NCT01031628|E3|Reported Event|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383548|NCT01031628|E2|Reported Event|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383549|NCT01031628|E1|Reported Event|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
383550|NCT01031550|B3|Baseline|Total|Total of all reporting groups
383551|NCT01031550|B2|Baseline|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
383552|NCT01031550|B1|Baseline|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
383553|NCT01031550|P2|Participant Flow|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane, anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
383554|NCT01031550|P1|Participant Flow|Standard Anesthetic Management|standard anesthetic management propofol 100-150mcg/kg/min
383555|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
383556|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
383557|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
383558|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
383559|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
383560|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
383561|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
383562|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
383671|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
383672|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
383673|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
383563|NCT01031550|E2|Reported Event|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
383564|NCT01031550|E1|Reported Event|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
383565|NCT01031498|B4|Baseline|Total|Total of all reporting groups
383566|NCT01031498|B3|Baseline|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
383567|NCT01031498|B2|Baseline|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
383568|NCT01031498|B1|Baseline|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
383569|NCT01031498|P3|Participant Flow|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
383570|NCT01031498|P2|Participant Flow|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
383571|NCT01031498|P1|Participant Flow|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
383572|NCT01031498|O3|Outcome|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
383573|NCT01031498|O2|Outcome|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
383574|NCT01031498|O1|Outcome|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
383575|NCT01031498|E3|Reported Event|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
383576|NCT01031498|E2|Reported Event|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
383577|NCT01031498|E1|Reported Event|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
383578|NCT01031446|B1|Baseline|RAD001 Cisplatin Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
383579|NCT01031446|P1|Participant Flow|RAD001 and Cisplatin and Pacletaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks. All patients began at the same dose level of the study drugs with no de-escalation of dose, thus results for Phase I and II were combined
383580|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
383581|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
383582|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
383583|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
383584|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
383585|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitazel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
383586|NCT01031446|E1|Reported Event|RAD001 and Cisplatin and Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
383587|NCT01031381|B1|Baseline|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
383588|NCT01031381|P1|Participant Flow|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
383589|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
383590|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously.
383591|NCT01031381|E1|Reported Event|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
383592|NCT01031134|B3|Baseline|Total|Total of all reporting groups
383593|NCT01031134|B2|Baseline|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
383594|NCT01031134|B1|Baseline|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
383595|NCT01031134|P2|Participant Flow|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
383596|NCT01031134|P1|Participant Flow|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
383597|NCT01031134|O2|Outcome|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
383598|NCT01031134|O1|Outcome|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
383599|NCT01031134|O2|Outcome|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
383600|NCT01031134|O1|Outcome|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
383601|NCT01031134|E2|Reported Event|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
383602|NCT01031134|E1|Reported Event|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
383603|NCT01031095|B3|Baseline|Total|Total of all reporting groups
383604|NCT01031095|B2|Baseline|Standard Therapy|standard UFH treatment
383605|NCT01031095|B1|Baseline|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
383606|NCT01031095|P2|Participant Flow|Standard Therapy|standard unfractionated heparin (UFH) treatment
383607|NCT01031095|P1|Participant Flow|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
383608|NCT01031095|O1|Outcome|Low Dose Intracoronary Heparin Treatment Arm|low dose intracoronary heparin treatment arm (intracoronary 1000 IU unfractioned heparin arm)
383609|NCT01031095|O1|Outcome|Standard Therapy|standard UFH treatment (intravenous standard dose unfractioned heparin group)
383610|NCT01031095|E2|Reported Event|Standard Therapy|standard UFH treatment
383611|NCT01031095|E1|Reported Event|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
383612|NCT01031043|B1|Baseline|Topical Bethanechol|patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
383613|NCT01031043|P1|Participant Flow|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
383674|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
383675|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
383676|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
384780|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
383614|NCT01031043|O1|Outcome|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
383615|NCT01031043|E1|Reported Event|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
383616|NCT01031004|B3|Baseline|Total|Total of all reporting groups
383617|NCT01031004|B2|Baseline|Etafilcon A|contact lens worn as single use, daily wear
383618|NCT01031004|B1|Baseline|Narafilcon B|single use, daily wear contact lens
383619|NCT01031004|P2|Participant Flow|Etafilcon A|contact lens worn as single use, daily wear
383620|NCT01031004|P1|Participant Flow|Narafilcon B|single use, daily wear contact lens
383621|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383622|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383623|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383624|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383625|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383626|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383627|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383628|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383629|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383630|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383631|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383632|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383633|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383634|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383635|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383636|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383637|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383638|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383639|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383640|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383641|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383642|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383643|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383644|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383645|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383646|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383647|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383648|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383649|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383650|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383651|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383652|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383653|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383654|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383655|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
383656|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
383657|NCT01031004|E2|Reported Event|Etafilcon A|contact lens worn as single use, daily wear
383658|NCT01031004|E1|Reported Event|Narafilcon B|single use, daily wear contact lens
383659|NCT01030965|B5|Baseline|Total|Total of all reporting groups
383660|NCT01030965|B4|Baseline|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
383661|NCT01030965|B3|Baseline|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
383662|NCT01030965|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
383663|NCT01030965|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
383664|NCT01030965|P4|Participant Flow|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
383665|NCT01030965|P3|Participant Flow|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
383666|NCT01030965|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
383667|NCT01030965|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
383668|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
383669|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
383670|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
383677|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
383678|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
383679|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
383680|NCT01030965|E4|Reported Event|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
383681|NCT01030965|E3|Reported Event|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
383682|NCT01030965|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
383683|NCT01030965|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
383684|NCT01030952|B3|Baseline|Total|Total of all reporting groups
383685|NCT01030952|B2|Baseline|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
383686|NCT01030952|B1|Baseline|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
383687|NCT01030952|P2|Participant Flow|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
383688|NCT01030952|P1|Participant Flow|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
383689|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383690|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383691|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383692|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383693|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383694|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383695|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383696|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383697|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383698|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383699|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383700|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383701|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383702|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383703|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383704|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383705|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
383706|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
383707|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
383708|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
383709|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383710|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383711|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383712|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383713|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383714|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383715|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383716|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383717|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383718|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383719|NCT01030952|E2|Reported Event|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
383720|NCT01030952|E1|Reported Event|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
383721|NCT01030822|B4|Baseline|Total|Total of all reporting groups
383722|NCT01030822|B3|Baseline|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383723|NCT01030822|B2|Baseline|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383861|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
383724|NCT01030822|B1|Baseline|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383725|NCT01030822|P3|Participant Flow|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383726|NCT01030822|P2|Participant Flow|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383727|NCT01030822|P1|Participant Flow|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383728|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383729|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383730|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383731|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383732|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383733|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383734|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383735|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383736|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383737|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383738|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383739|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383740|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383741|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383862|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
383742|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383743|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383744|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383745|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383746|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383747|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383748|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383749|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383750|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383751|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383752|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383753|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383754|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383755|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383756|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383757|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383758|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383759|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383863|NCT01030653|E2|Reported Event|Voriconazole Low Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
383760|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383761|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383762|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383763|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383764|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383765|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383766|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383767|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383768|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383769|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383770|NCT01030822|E3|Reported Event|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
383771|NCT01030822|E2|Reported Event|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
383772|NCT01030822|E1|Reported Event|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
383773|NCT01030757|B1|Baseline|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
383774|NCT01030757|P1|Participant Flow|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
383775|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
384160|NCT01029691|O2|Outcome|Positive Airway Pressure Non Adherent|Positive Airway Pressure: Women who used positive airway pressure for limited time
383776|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
383777|NCT01030757|E1|Reported Event|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
383778|NCT01030718|B4|Baseline|Total|Total of all reporting groups
383779|NCT01030718|B3|Baseline|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383780|NCT01030718|B2|Baseline|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383781|NCT01030718|B1|Baseline|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383782|NCT01030718|P3|Participant Flow|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Philadelphia chromosome positive (Ph+) ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383783|NCT01030718|P2|Participant Flow|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383784|NCT01030718|P1|Participant Flow|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383785|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383786|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383787|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383788|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383789|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383864|NCT01030653|E1|Reported Event|Voriconazole High Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
383865|NCT01030536|B6|Baseline|Total|Total of all reporting groups
384288|NCT01029392|B2|Baseline|No Vit D Supplementation|Normal vitamin D levels No Vitamin D supplement
383790|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383791|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383792|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383793|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383794|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383795|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383796|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383797|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383798|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383799|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383800|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383801|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383802|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383803|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383836|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383804|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383805|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383806|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383807|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383808|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383809|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383810|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383811|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383812|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383813|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383814|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383815|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383816|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383817|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383818|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383819|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
384038|NCT01029795|B3|Baseline|Total|Total of all reporting groups
384781|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
383820|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383821|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383822|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383823|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383824|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383825|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383826|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383827|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383828|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383829|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383830|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383831|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383832|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383833|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383834|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383835|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
392207|NCT01011335|O10|Outcome|rLukS 10 µg|
383837|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383838|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383839|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383840|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383841|NCT01030718|E1|Reported Event|All Treated Participants|Imatinib resistant or intolerant CML-CP disease cohort, Imatinib resistant or intolerant CML-AP/BP disease cohort, and Ph+ ALL subjects with resistance or intolerance to past therapy. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
383842|NCT01030666|B3|Baseline|Total|Total of all reporting groups
383843|NCT01030666|B2|Baseline|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
383844|NCT01030666|B1|Baseline|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
383845|NCT01030666|P2|Participant Flow|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
383846|NCT01030666|P1|Participant Flow|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
383847|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
383848|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
383849|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
383850|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects addionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
383851|NCT01030666|E2|Reported Event|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
383852|NCT01030666|E1|Reported Event|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
383853|NCT01030653|B3|Baseline|Total|Total of all reporting groups
383854|NCT01030653|B2|Baseline|Voriconazole Low Dose First Then High Dose|
383855|NCT01030653|B1|Baseline|Voriconazole High Dose First Then Low Dose|Both voriconazole arms are shown as a single group because the same individuals received both arms of the intervention in a cross-over design.
383856|NCT01030653|P2|Participant Flow|Voriconazole Low Dose First Then High Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses)
383857|NCT01030653|P1|Participant Flow|Voriconazole High Dose First Then Low Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses)
383858|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
383859|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
383860|NCT01030653|O1|Outcome|Voriconazole High : Low Dose|"Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)~Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)"
383866|NCT01030536|B5|Baseline|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383867|NCT01030536|B4|Baseline|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383868|NCT01030536|B3|Baseline|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383869|NCT01030536|B2|Baseline|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383870|NCT01030536|B1|Baseline|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383871|NCT01030536|P5|Participant Flow|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383872|NCT01030536|P4|Participant Flow|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383873|NCT01030536|P3|Participant Flow|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383874|NCT01030536|P2|Participant Flow|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383875|NCT01030536|P1|Participant Flow|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383876|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383877|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383878|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383879|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383880|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
384039|NCT01029795|B2|Baseline|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
392208|NCT01011335|O9|Outcome|Saline Placebo (for rAT)|
383881|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383882|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383883|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383884|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383885|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383886|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383887|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383888|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383889|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383890|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383891|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383892|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383893|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383894|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383895|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383896|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383897|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383898|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383899|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383900|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383901|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383902|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383903|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383904|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383905|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383906|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383907|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383908|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383909|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383910|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383911|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383912|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383913|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383914|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383915|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383916|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383917|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383918|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383919|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383920|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383921|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383922|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383923|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383924|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383925|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383926|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383927|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
384040|NCT01029795|B1|Baseline|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
383928|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383929|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383930|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383931|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383932|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383933|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383934|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383935|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383936|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383937|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383938|NCT01030536|O4|Outcome|Follicular Lymphoma|Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383939|NCT01030536|O3|Outcome|Mantle Cell Lymphoma|Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383940|NCT01030536|O2|Outcome|Diffuse Large B Cell Lymphoma|Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383941|NCT01030536|O1|Outcome|Chronic Lymphocytic Leukemia|Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
383942|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
384041|NCT01029795|P2|Participant Flow|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
383943|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383944|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383945|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383946|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383947|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383948|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383949|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383950|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383951|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383952|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383953|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383954|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383955|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383956|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383957|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383958|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383959|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383960|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383961|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383962|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383963|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383964|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383965|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383966|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383967|NCT01030536|O5|Outcome|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383968|NCT01030536|O4|Outcome|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383969|NCT01030536|O3|Outcome|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383970|NCT01030536|O2|Outcome|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383971|NCT01030536|O1|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383972|NCT01030536|E5|Reported Event|CAT-8015 60 Microgram Per Kilogram (mcg/kg)|Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383973|NCT01030536|E4|Reported Event|CAT-8015 50 Microgram Per Kilogram (mcg/kg)|Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383974|NCT01030536|E3|Reported Event|CAT-8015 40 Microgram Per Kilogram (mcg/kg)|Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383975|NCT01030536|E2|Reported Event|CAT-8015 30 Microgram Per Kilogram (mcg/kg)|Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383976|NCT01030536|E1|Reported Event|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
383977|NCT01030458|B3|Baseline|Total|Total of all reporting groups
383978|NCT01030458|B2|Baseline|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
383979|NCT01030458|B1|Baseline|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
383980|NCT01030458|P2|Participant Flow|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
383981|NCT01030458|P1|Participant Flow|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
383982|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
383983|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
383984|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
383985|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
383986|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
383987|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
383988|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
383989|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
383990|NCT01030458|E2|Reported Event|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
383991|NCT01030458|E1|Reported Event|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
383992|NCT01029925|B1|Baseline|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
383993|NCT01029925|P1|Participant Flow|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
383994|NCT01029925|O1|Outcome|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
383995|NCT01029925|E1|Reported Event|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
383996|NCT01029912|B3|Baseline|Total|Total of all reporting groups
383997|NCT01029912|B2|Baseline|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
383998|NCT01029912|B1|Baseline|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
383999|NCT01029912|P2|Participant Flow|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Cyclic NMES Electrical Stimulator: 6-week intervention~Home: Self-administered active repetitive Cyclic NMES-mediated ankle dorsiflexion exercise performed ten 51-minute sessions (three 15-min sets separated by 3-min rest) per week at home.~Lab: 15 minutes of therapist-guided Cyclic NMES-mediated ankle exercise + 30 minutes of gait training in the laboratory twice a week."
384042|NCT01029795|P1|Participant Flow|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384000|NCT01029912|P1|Participant Flow|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~CCFES Electrical Stimulator: 6-week intervention~Home: Self-administered active repetitive CCNMES-mediated ankle dorsiflexion exercise performed ten 51-minute sessions (three 15-min sets separated by 3-min rest) per week at home.~Lab: 15 minutes of therapist-guided CCFES-mediated ankle exercise + 30 minutes of gait training in the laboratory twice a week."
384001|NCT01029912|O2|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384002|NCT01029912|O1|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384003|NCT01029912|O2|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384004|NCT01029912|O1|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384005|NCT01029912|O2|Outcome|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384006|NCT01029912|O1|Outcome|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384007|NCT01029912|E2|Reported Event|Cyclic NMES|"Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384008|NCT01029912|E1|Reported Event|CCNMES|"Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator)~Electrical stimulator: 6-week intervention~15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.~Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device."
384009|NCT01029886|B3|Baseline|Total|Total of all reporting groups
384010|NCT01029886|B2|Baseline|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384011|NCT01029886|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384012|NCT01029886|P2|Participant Flow|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384013|NCT01029886|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384014|NCT01029886|O4|Outcome|Liraglutide Once Daily Without SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and without SU use at screening
384015|NCT01029886|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection, 2mg, once weekly and without SU use at screening
384016|NCT01029886|O2|Outcome|Liraglutide Once Daily With SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and with SU use at screening
384017|NCT01029886|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection, 2mg, once weekly and with SU use at screening
384018|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384019|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384020|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384021|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384022|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384023|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384024|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384025|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384026|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384027|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384028|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384029|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384030|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384031|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384032|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384033|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384034|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384035|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384036|NCT01029886|E2|Reported Event|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
384037|NCT01029886|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
384043|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384044|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384045|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384046|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384047|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384048|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384049|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384050|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384051|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384052|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384053|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384054|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384055|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384056|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384057|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384058|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384059|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384060|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384061|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384062|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384155|NCT01029691|O1|Outcome|Nocturnal Hypertension|Women with nocturnal hypertension (defined as blood pressure >117/68mmHg between 26-30 weeks and >123/72mmHg after 30 weeks)
384063|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384064|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384065|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384066|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384067|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384068|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384069|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384070|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384071|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384072|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384073|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384074|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384075|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384076|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384077|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384078|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384079|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384080|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384081|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384082|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384156|NCT01029691|O3|Outcome|Standard Care|
384289|NCT01029392|B1|Baseline|Those Requiring Vit D Supplement|"Those who had a Vit D level of < 30~Vitamin D: 2000iu once a day"
384083|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384084|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384085|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384086|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384087|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384088|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384089|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384090|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384091|NCT01029795|E2|Reported Event|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
384092|NCT01029795|E1|Reported Event|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
384093|NCT01029730|B1|Baseline|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
384094|NCT01029730|P1|Participant Flow|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
384095|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
384096|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
384097|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
384098|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
384157|NCT01029691|O2|Outcome|Positive Airway Pressure Non Adherent|Positive Airway Pressure: Women who used positive airway pressure for limited time
384158|NCT01029691|O1|Outcome|Positive Airway Pressure Adherent|Positive Airway Pressure: Women will use positive airway pressure until delivery
384159|NCT01029691|O3|Outcome|Standard Care|
384099|NCT01029730|E1|Reported Event|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
384100|NCT01029704|B6|Baseline|Total|Total of all reporting groups
384101|NCT01029704|B5|Baseline|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
384102|NCT01029704|B4|Baseline|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
384103|NCT01029704|B3|Baseline|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
384104|NCT01029704|B2|Baseline|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
384105|NCT01029704|B1|Baseline|Placebo|Received no drug (EGT0001442) during 28 days
384106|NCT01029704|P5|Participant Flow|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
384107|NCT01029704|P4|Participant Flow|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
384108|NCT01029704|P3|Participant Flow|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
384109|NCT01029704|P2|Participant Flow|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
384110|NCT01029704|P1|Participant Flow|Placebo|Received no drug (EGT0001442) during 28 days
384111|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
384112|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
384113|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
384114|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
384115|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
384116|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
384117|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
384118|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
384119|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
384120|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
384121|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
384122|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
384123|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
384124|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
384125|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
384126|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
384127|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
384128|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
384129|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
384130|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
384131|NCT01029704|E5|Reported Event|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
384132|NCT01029704|E4|Reported Event|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
384133|NCT01029704|E3|Reported Event|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
384134|NCT01029704|E2|Reported Event|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
384135|NCT01029704|E1|Reported Event|Placebo|Received no drug (EGT0001442) during 28 days
384136|NCT01029691|B4|Baseline|Total|Total of all reporting groups
384137|NCT01029691|B3|Baseline|Standard Care|Non-APAP arm
384138|NCT01029691|B2|Baseline|Non-compliant APAP|Women who did not use APAP for at least 4 hours/night
384139|NCT01029691|B1|Baseline|Compliant Autotitrating Positive Airway Pressure (APAP)|Women who used APAP for at least 4 hours/night
384140|NCT01029691|P3|Participant Flow|Standard of Care|Women in the standard of care group will have clinical blood pressure measurements extracted from medical records. Delivery information will also be collected.
384141|NCT01029691|P2|Participant Flow|Non-Compliant APAP|Women who were in the APAP arm but who used less than 4 hours per night
384142|NCT01029691|P1|Participant Flow|Compliant Users APAP|Women who used APAP at least 4 hours per night. Auto-titrating Positive Airway Pressure: Women will use APAP until delivery. Nocturnal blood pressure will be assessed at two time points: 1 week of APAP use and at regular intervals across pregnancy. Daytime blood pressure measurements across pregnancy will be obtained from medical records along with delivery information.
384143|NCT01029691|O3|Outcome|Standard Care|
384144|NCT01029691|O2|Outcome|Positive Airway Pressure Non Adherent|Positive Airway Pressure: Women who used positive airway pressure for limited time
384145|NCT01029691|O1|Outcome|Positive Airway Pressure Adherent|Positive Airway Pressure: Women will use positive airway pressure until delivery
384146|NCT01029691|O3|Outcome|Standard Care|
384147|NCT01029691|O2|Outcome|Positive Airway Pressure Non Adherent|Positive Airway Pressure: Women who used positive airway pressure for limited time
384148|NCT01029691|O1|Outcome|Positive Airway Pressure Adherent|Positive Airway Pressure: Women will use positive airway pressure until delivery
384149|NCT01029691|O3|Outcome|Standard Care|
384150|NCT01029691|O2|Outcome|Positive Airway Pressure Non Adherent|Positive Airway Pressure: Women who used positive airway pressure for limited time
384151|NCT01029691|O1|Outcome|Positive Airway Pressure Adherent|Positive Airway Pressure: Women will use positive airway pressure until delivery
384152|NCT01029691|O2|Outcome|No Nocturnal Hypertension|Women without nocturnal hypertension
384153|NCT01029691|O1|Outcome|Nocturnal Hypertension|Women with nocturnal hypertension (defined as blood pressure >117/68mmHg between 26-30 weeks and >123/72mmHg after 30 weeks)
384154|NCT01029691|O2|Outcome|No Nocturnal Hypertension|Women without nocturnal hypertension
384161|NCT01029691|O1|Outcome|Positive Airway Pressure Adherent|Positive Airway Pressure: Women will use positive airway pressure until delivery
384162|NCT01029691|E2|Reported Event|Standard Care|
384163|NCT01029691|E1|Reported Event|Positive Airway Pressure|Positive Airway Pressure: Women will use positive airway pressure until delivery
384164|NCT01029652|B3|Baseline|Total|Total of all reporting groups
384165|NCT01029652|B2|Baseline|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384166|NCT01029652|B1|Baseline|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384167|NCT01029652|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study ."
384168|NCT01029652|P1|Participant Flow|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study"
384169|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384170|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384171|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384172|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384173|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384290|NCT01029392|P2|Participant Flow|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
392209|NCT01011335|O8|Outcome|Alum Placebo (for rAT)|
384174|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384175|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384176|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384177|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384178|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384179|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384180|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384181|NCT01029652|O6|Outcome|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
384182|NCT01029652|O5|Outcome|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
384183|NCT01029652|O4|Outcome|Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
384291|NCT01029392|P1|Participant Flow|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL~Vitamin D: 2000 IU once a day"
384782|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
384184|NCT01029652|O3|Outcome|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
384185|NCT01029652|O2|Outcome|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
384186|NCT01029652|O1|Outcome|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384187|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384188|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384189|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384190|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384191|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. Note that flare rate was calculated using only those new flares before switching."
384192|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384193|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
384194|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384195|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384196|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384197|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384198|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384199|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384200|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384201|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384202|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384203|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384204|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384205|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
384206|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384292|NCT01029392|O2|Outcome|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
392210|NCT01011335|O7|Outcome|rAT/rLukS 50 µg (for rAT)|
384207|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384208|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384209|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384210|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384211|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384212|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384213|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384214|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384215|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384216|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384217|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384218|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384219|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
392211|NCT01011335|O6|Outcome|rAT/rLukS 25 µg (for rAT)|
384220|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384221|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384222|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384223|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384224|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384225|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384226|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384227|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384228|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384229|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384230|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384231|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384232|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
392212|NCT01011335|O5|Outcome|rAT/rLukS 10 µg (for rAT)|
384233|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384234|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384235|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384236|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384237|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384238|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
384239|NCT01029652|E6|Reported Event|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
384240|NCT01029652|E5|Reported Event|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
384241|NCT01029652|E4|Reported Event|All Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
384242|NCT01029652|E3|Reported Event|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
384243|NCT01029652|E2|Reported Event|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
384244|NCT01029652|E1|Reported Event|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
384245|NCT01029535|B1|Baseline|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384246|NCT01029535|P1|Participant Flow|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384293|NCT01029392|O1|Outcome|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL~Vitamin D: 2000 IU once a day"
384247|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384248|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384249|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384250|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384251|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384252|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384253|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384254|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384255|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384256|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384257|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384258|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384259|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384260|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384261|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384262|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384263|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384264|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384265|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384294|NCT01029392|O2|Outcome|No Vitamin D Supplementation|Those with normal vitamin D levels (50-80 ng/mL) No vitamin D supplemenation
384266|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384267|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384268|NCT01029535|E2|Reported Event|Juvederm® VOLUMA™_Phase 2|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384269|NCT01029535|E1|Reported Event|Juvederm® VOLUMA™_Phase 1|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
384270|NCT01029405|B5|Baseline|Total|Total of all reporting groups
384271|NCT01029405|B4|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384272|NCT01029405|B3|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384273|NCT01029405|B2|Baseline|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384274|NCT01029405|B1|Baseline|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384275|NCT01029405|P4|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384276|NCT01029405|P3|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384277|NCT01029405|P2|Participant Flow|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384278|NCT01029405|P1|Participant Flow|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent (%) and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384279|NCT01029405|O3|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384280|NCT01029405|O2|Outcome|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384281|NCT01029405|O1|Outcome|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384282|NCT01029405|O1|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384283|NCT01029405|E4|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384284|NCT01029405|E3|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384285|NCT01029405|E2|Reported Event|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384286|NCT01029405|E1|Reported Event|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
384287|NCT01029392|B3|Baseline|Total|Total of all reporting groups
384295|NCT01029392|O1|Outcome|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 Vitamin D: 2000iu once a day
384296|NCT01029392|E2|Reported Event|No Vit D Supplementation|Normal vitamin D levels (50-80 ng/mL) No vitamin D supplementation
384297|NCT01029392|E1|Reported Event|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 ng/mL Vitamin D: 2000iu once a day
384298|NCT01029366|B3|Baseline|Total|Total of all reporting groups
384299|NCT01029366|B2|Baseline|ALL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
384300|NCT01029366|B1|Baseline|CLL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
384301|NCT01029366|P2|Participant Flow|Acute Lymphocytic Leukemia (ALL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹
384302|NCT01029366|P1|Participant Flow|Chronic Lymphocytic Leukemia (CLL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹.
384303|NCT01029366|O2|Outcome|ALL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity~laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
384304|NCT01029366|O1|Outcome|CLL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity~laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
384305|NCT01029366|O1|Outcome|All Participants|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
384306|NCT01029366|E2|Reported Event|Acute Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
384307|NCT01029366|E1|Reported Event|Chronic Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
384308|NCT01029340|B6|Baseline|Total|Total of all reporting groups
384309|NCT01029340|B5|Baseline|Arm 5: Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
384310|NCT01029340|B4|Baseline|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months
384311|NCT01029340|B3|Baseline|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months
384312|NCT01029340|B2|Baseline|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
384313|NCT01029340|B1|Baseline|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
384314|NCT01029340|P6|Participant Flow|Arm 6: Recombinant Factor VIII (BAY81-8973) Part B + Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
384315|NCT01029340|P5|Participant Flow|Arm 5: Recombinant Factor VIII by CS/EP|Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
384316|NCT01029340|P4|Participant Flow|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia (CS/EP) for 6 months
384566|NCT01028222|B1|Baseline|Nilotinib|400 mg twice daily
384567|NCT01028222|P2|Participant Flow|DTIC|850 mg/m2 IV every 3 weeks
384317|NCT01029340|P3|Participant Flow|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
384318|NCT01029340|P2|Participant Flow|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
384319|NCT01029340|P1|Participant Flow|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
384320|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
384321|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
384322|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
384323|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
384324|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
384325|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
384326|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
384327|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
384328|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
384329|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
384330|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
384331|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
384332|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
384333|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
384334|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
384335|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
384336|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
384337|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
384338|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
384339|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
384340|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
384341|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
384342|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
384343|NCT01029340|E4|Reported Event|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants in Part C received a loading dose of approximately 50 IU/kg of BAY81-8973 (nearest whole vial amount) for less than 15 minutes before the first surgical incision. Then they received further treatment with BAY81-8973 according to surgical requirements up to 3 weeks.
384344|NCT01029340|E3|Reported Event|Recombinant Factor VIII (BAY81-8973) Part B and Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
384345|NCT01029340|E2|Reported Event|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
384346|NCT01029340|E1|Reported Event|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
384347|NCT01029262|B3|Baseline|Total|Total of all reporting groups
384348|NCT01029262|B2|Baseline|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384349|NCT01029262|B1|Baseline|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384350|NCT01029262|P2|Participant Flow|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384351|NCT01029262|P1|Participant Flow|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384352|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384353|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384354|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384355|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384356|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384357|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384358|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384359|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384360|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384361|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384362|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384363|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384364|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384365|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384366|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384367|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384368|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384369|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384370|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384371|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384372|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384373|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384374|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384375|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384376|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384377|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384378|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384379|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects or withdrawal of consent.
384380|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384381|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384382|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384383|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384384|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384385|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384386|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min."
384387|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects.
384388|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384389|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384390|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384391|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384392|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384393|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
392213|NCT01011335|O4|Outcome|rAT 100 µg|
384394|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384395|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384396|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384397|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384398|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384399|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384400|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384401|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384402|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
384403|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
384404|NCT01029262|E2|Reported Event|Lenalidomide|Lenalidomide 10 mg daily (QD) by mouth (PO) + 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Or 5 mg Lenalidomide capsule + 2 placebo capsules PO QD for participants with a creatinine clearance between 40 and 60 mL/min.
384405|NCT01029262|E1|Reported Event|Placebo|3 placebo capsules PO QD for at least 168 days unless disease progression or intolerable side effects.
384406|NCT01029054|B1|Baseline|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384407|NCT01029054|P3|Participant Flow|Dose Escalation Cohort 3|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 36 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384408|NCT01029054|P2|Participant Flow|Dose Escalation Cohort 2|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 27 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384409|NCT01029054|P1|Participant Flow|Dose Escalation Cohort 1|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 20 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384410|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384411|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384412|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384413|NCT01029054|E1|Reported Event|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
384414|NCT01028911|B3|Baseline|Total|Total of all reporting groups
384568|NCT01028222|P1|Participant Flow|Nilotinib|400 mg twice daily
384415|NCT01028911|B2|Baseline|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384416|NCT01028911|B1|Baseline|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384417|NCT01028911|P2|Participant Flow|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384418|NCT01028911|P1|Participant Flow|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384419|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384420|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384421|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384422|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384423|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384424|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384425|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384426|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384427|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384428|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384429|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384430|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384431|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384569|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
384432|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384433|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384434|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384435|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384436|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384437|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384438|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384439|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384440|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384441|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384442|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384443|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384444|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384445|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384446|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384447|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384448|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384449|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384570|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
384571|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
392214|NCT01011335|O3|Outcome|rAT 50 µg|
384450|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384451|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384452|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384453|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384454|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384455|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384456|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384457|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384458|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384459|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384460|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384461|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384462|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384463|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384464|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384465|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384466|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384467|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384572|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
384573|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
392215|NCT01011335|O2|Outcome|rAT 25 µg|
384468|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384469|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384470|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384471|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384472|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384473|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384474|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384475|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384476|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384477|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384478|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384479|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384480|NCT01028911|E2|Reported Event|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384481|NCT01028911|E1|Reported Event|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
384482|NCT01028820|B1|Baseline|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
384483|NCT01028820|P1|Participant Flow|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
384484|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
384485|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
384486|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
384487|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
384488|NCT01028820|E1|Reported Event|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
384489|NCT01028677|B3|Baseline|Total|Total of all reporting groups
384490|NCT01028677|B2|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384491|NCT01028677|B1|Baseline|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384492|NCT01028677|P2|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 6 weeks"
384493|NCT01028677|P1|Participant Flow|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384494|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384495|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384496|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384497|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384498|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384499|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384500|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384501|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384502|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384503|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384504|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384505|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384506|NCT01028677|E2|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
384507|NCT01028677|E1|Reported Event|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
384508|NCT01028651|B1|Baseline|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384509|NCT01028651|P1|Participant Flow|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384510|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384511|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384512|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384513|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384514|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384515|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384516|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384517|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384518|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384519|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384520|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384521|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384522|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384523|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384524|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384525|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384526|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384527|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384528|NCT01028651|E1|Reported Event|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
384529|NCT01028391|B3|Baseline|Total|Total of all reporting groups
384530|NCT01028391|B2|Baseline|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
384531|NCT01028391|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
384532|NCT01028391|P2|Participant Flow|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
384533|NCT01028391|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
384534|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
384535|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
384536|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
384537|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
384538|NCT01028391|E2|Reported Event|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
384574|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
384575|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
384576|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
384539|NCT01028391|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
384540|NCT01028378|B1|Baseline|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384541|NCT01028378|P1|Participant Flow|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384542|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384543|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384544|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384545|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384546|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384547|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384548|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384549|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384550|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384551|NCT01028378|E1|Reported Event|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
384552|NCT01028352|B1|Baseline|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
384553|NCT01028352|P1|Participant Flow|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
384554|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
384555|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
384556|NCT01028352|E1|Reported Event|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
384557|NCT01028300|B1|Baseline|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
384558|NCT01028300|P1|Participant Flow|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
384559|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
384560|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
384561|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
384562|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
384563|NCT01028300|E1|Reported Event|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
384564|NCT01028222|B3|Baseline|Total|Total of all reporting groups
384565|NCT01028222|B2|Baseline|DTIC|850 mg/m2 IV every 3 weeks
384589|NCT01028131|B4|Baseline|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
384590|NCT01028131|B3|Baseline|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples - cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
384591|NCT01028131|B2|Baseline|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
384592|NCT01028131|B1|Baseline|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
384593|NCT01028131|P4|Participant Flow|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
384594|NCT01028131|P3|Participant Flow|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples(looking for clean samples with cotinine less than 100 ng/ml) at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
384595|NCT01028131|P2|Participant Flow|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
384596|NCT01028131|P1|Participant Flow|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
384597|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
384598|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
384599|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
384600|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
384601|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
384602|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
384603|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
384604|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
384605|NCT01028131|E4|Reported Event|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
384606|NCT01028131|E3|Reported Event|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
384607|NCT01028131|E2|Reported Event|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
384608|NCT01028131|E1|Reported Event|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
384609|NCT01028053|B1|Baseline|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
384641|NCT01028014|P6|Participant Flow|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
392216|NCT01011335|O1|Outcome|rAT 10 µg|
384610|NCT01028053|P1|Participant Flow|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
384611|NCT01028053|O2|Outcome|Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to clinically probable Alzheimer’s Disease (pAD).
384612|NCT01028053|O1|Outcome|Not Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to not clinically probable Alzheimer’s Disease (pAD).
384613|NCT01028053|O1|Outcome|Hazard Ratio|"The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.~As the HR increases above 1, the chances of being probable Alzheimer’s Disease (pAD) also increases."
384614|NCT01028053|E1|Reported Event|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
384615|NCT01028027|B3|Baseline|Total|Total of all reporting groups
384616|NCT01028027|B2|Baseline|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384617|NCT01028027|B1|Baseline|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384618|NCT01028027|P2|Participant Flow|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384619|NCT01028027|P1|Participant Flow|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384620|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384621|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384622|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384623|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384624|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384625|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384626|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384627|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384628|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384629|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384630|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384631|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384632|NCT01028027|E2|Reported Event|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384633|NCT01028027|E1|Reported Event|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
384634|NCT01028014|B7|Baseline|Total|Total of all reporting groups
384635|NCT01028014|B6|Baseline|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
384636|NCT01028014|B5|Baseline|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
384637|NCT01028014|B4|Baseline|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
384638|NCT01028014|B3|Baseline|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
384639|NCT01028014|B2|Baseline|Solifenacin 5mg Daily|5 mg capsule, 1 daily for 14 days
384640|NCT01028014|B1|Baseline|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 daily for 14 days
396537|NCT01000285|O2|Outcome|Patient A (Responder) Post-Therapy|
384646|NCT01028014|P1|Participant Flow|Pseudoephedrine 120mg ER Daily|120 mg extended release tablet one daily for 14 days
384647|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
384648|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
384649|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
384650|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
384651|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
384652|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
384653|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
384654|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
384655|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
384656|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
384657|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
384658|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
384659|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
384660|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
384661|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
384662|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
384663|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
384664|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
384665|NCT01028014|E6|Reported Event|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
384666|NCT01028014|E5|Reported Event|Cyclobenzaprine 10mg Daily|10mg tablet, one daily for 14 days
384667|NCT01028014|E4|Reported Event|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
384668|NCT01028014|E3|Reported Event|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
384669|NCT01028014|E2|Reported Event|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
384670|NCT01028014|E1|Reported Event|Pseudoephedrine 120mg ER Daily|120mg extended release, one daily for 14 days
384671|NCT01027910|B3|Baseline|Total|Total of all reporting groups
384672|NCT01027910|B2|Baseline|PCI-24781 + Doxorubicin With Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, with (Arm B) mandatory G-CSF support was established.
384673|NCT01027910|B1|Baseline|PCI-24781 + Doxorubicin Without Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, without (Arm A) mandatory G-CSF support was established.
384674|NCT01027910|P2|Participant Flow|PCI-24781 + Doxorubicin With Mandatory GCSF|"PCI-24781 + Doxorubicin with mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
384675|NCT01027910|P1|Participant Flow|PCI-24781 + Doxorubicin Without Mandatory GCSF|"PCI-24781 + Doxorubicin without mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
384676|NCT01027910|O2|Outcome|Mandatory GCSF|
384677|NCT01027910|O1|Outcome|Optional GCSF|
384678|NCT01027910|O2|Outcome|Mandatory GCSF|
384679|NCT01027910|O1|Outcome|Optional GCSF|
384680|NCT01027910|O2|Outcome|Mandatory GCSF|
384681|NCT01027910|O1|Outcome|Optional GCSF|
384682|NCT01027910|O2|Outcome|PCI-24781 With Mandatory GCSF|
384683|NCT01027910|O1|Outcome|PCI-24781 + Doxorubicin Without Mandatory GCSF|
384684|NCT01027910|E2|Reported Event|PCI-24781+Dox With Mandated GCSF|Patients in this are were mandated treatment with GCSF
384685|NCT01027910|E1|Reported Event|PCI-24781+Dox Without Mandated GCSF|Patients in this arm were not mandated treatment with GCSF
384686|NCT01027897|B1|Baseline|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
384687|NCT01027897|P1|Participant Flow|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
384688|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
384689|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
384690|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
384691|NCT01027897|E1|Reported Event|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
384692|NCT01027884|B3|Baseline|Total|Total of all reporting groups
384693|NCT01027884|B2|Baseline|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
384694|NCT01027884|B1|Baseline|Placebo|Two matching placebo tablets were taken three times a day with meals
384695|NCT01027884|P2|Participant Flow|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
384696|NCT01027884|P1|Participant Flow|Placebo|Two matching placebo tablets were taken three times a day with meals
384697|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
384698|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
384699|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
384700|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
384701|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
384702|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
384703|NCT01027884|O2|Outcome|Idebenone|"Idebenone 900 mg/day~Idebenone: Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
384704|NCT01027884|O1|Outcome|Placebo|"Placebo 900 mg/day~Placebo: Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
384705|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
384706|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
384707|NCT01027884|E2|Reported Event|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
384708|NCT01027884|E1|Reported Event|Placebo|Two matching placebo tablets were taken three times a day with meals
384709|NCT01027819|B3|Baseline|Total|Total of all reporting groups
384710|NCT01027819|B2|Baseline|Fixed Bearing|Mobile bearing vs Fixed bearing
384711|NCT01027819|B1|Baseline|Mobile Bearing|Mobile bearing vs Fixed bearing
384712|NCT01027819|P2|Participant Flow|Fixed Bearing|Mobile bearing vs Fixed bearing
384713|NCT01027819|P1|Participant Flow|Mobile Bearing|Mobile bearing vs Fixed bearing
384714|NCT01027819|O2|Outcome|Fixed Bearing|Mobile bearing vs Fixed bearing
384715|NCT01027819|O1|Outcome|Mobile Bearing|Mobile bearing vs Fixed bearing
384716|NCT01027819|E2|Reported Event|Fixed Bearing|Mobile bearing vs Fixed bearing
384717|NCT01027819|E1|Reported Event|Mobile Bearing|Mobile bearing vs Fixed bearing
384718|NCT01027780|B3|Baseline|Total|Total of all reporting groups
384719|NCT01027780|B2|Baseline|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
384720|NCT01027780|B1|Baseline|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
384721|NCT01027780|P2|Participant Flow|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
384722|NCT01027780|P1|Participant Flow|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
384723|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
384724|NCT01027780|O1|Outcome|Mindfulness Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
384725|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
384726|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
384727|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
384728|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
384729|NCT01027780|E2|Reported Event|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
384730|NCT01027780|E1|Reported Event|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
384731|NCT01027702|B1|Baseline|Infusion of Donor Lymphocytes|"Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.~Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased."
384732|NCT01027702|P7|Participant Flow|MUD: 3 x 10^4/kg DLI + MTX to Day +52|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384733|NCT01027702|P6|Participant Flow|MUD: 3 x 10^4/kg DLI + MTX to Day +24|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
384734|NCT01027702|P5|Participant Flow|MMRD: 5 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
384735|NCT01027702|P4|Participant Flow|MMRD: 4 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
384736|NCT01027702|P3|Participant Flow|MMRD: 4 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384737|NCT01027702|P2|Participant Flow|MMRD: 3 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384783|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
384738|NCT01027702|P1|Participant Flow|MMRD: 3 x 10^4/kg DLI + MTX to Day +24|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
384739|NCT01027702|O1|Outcome|Infusion of Donor Lymphocytes|"Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.~Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased."
384740|NCT01027702|O7|Outcome|MUD: 3 x 10^4/kg DLI + MTX to Day +52|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384741|NCT01027702|O6|Outcome|MUD: 3 x 10^4/kg DLI + MTX to Day +24|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
384742|NCT01027702|O5|Outcome|MMRD: 5 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
384743|NCT01027702|O4|Outcome|MMRD: 4 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
384744|NCT01027702|O3|Outcome|MMRD: 4 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384745|NCT01027702|O2|Outcome|MMRD: 3 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384746|NCT01027702|O1|Outcome|MMRD: 3 x 10^4/kg DLI + MTX to Day +24|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
384747|NCT01027702|O7|Outcome|MUD: 3 x 10^4/kg DLI + MTX to Day +52|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384748|NCT01027702|O6|Outcome|MUD: 3 x 10^4/kg DLI + MTX to Day +24|Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
384749|NCT01027702|O5|Outcome|MMRD: 5 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
384750|NCT01027702|O4|Outcome|MMRD: 4 x 10^4/kg DLI + MTX to Day +80|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
384751|NCT01027702|O3|Outcome|MMRD: 4 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384752|NCT01027702|O2|Outcome|MMRD: 3 x 10^4/kg DLI + MTX to Day +52|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
384753|NCT01027702|O1|Outcome|MMRD: 3 x 10^4/kg DLI + MTX to Day +24|Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
384754|NCT01027702|E1|Reported Event|Infusion of Donor Lymphocytes|"Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.~Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased."
384755|NCT01027650|B9|Baseline|Total|Total of all reporting groups
384756|NCT01027650|B8|Baseline|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
384757|NCT01027650|B7|Baseline|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
384758|NCT01027650|B6|Baseline|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
384759|NCT01027650|B5|Baseline|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
384760|NCT01027650|B4|Baseline|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
384761|NCT01027650|B3|Baseline|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
384762|NCT01027650|B2|Baseline|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
384763|NCT01027650|B1|Baseline|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
384764|NCT01027650|P8|Participant Flow|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
384765|NCT01027650|P7|Participant Flow|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
384766|NCT01027650|P6|Participant Flow|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
384767|NCT01027650|P5|Participant Flow|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
384768|NCT01027650|P4|Participant Flow|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
384769|NCT01027650|P3|Participant Flow|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
384770|NCT01027650|P2|Participant Flow|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
384771|NCT01027650|P1|Participant Flow|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
384772|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
384773|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
384774|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
384775|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
384784|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
384785|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
384786|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
384787|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
384788|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
384789|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
384790|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
384791|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
384792|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
384793|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
384794|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
384795|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
384796|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
384797|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
384798|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
384799|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
384800|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
384801|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
384802|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
384803|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
384804|NCT01027650|E8|Reported Event|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
384805|NCT01027650|E7|Reported Event|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
384806|NCT01027650|E6|Reported Event|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
384807|NCT01027650|E5|Reported Event|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
384808|NCT01027650|E4|Reported Event|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
384809|NCT01027650|E3|Reported Event|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
384810|NCT01027650|E2|Reported Event|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
384811|NCT01027650|E1|Reported Event|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
384812|NCT01027598|B3|Baseline|Total|Total of all reporting groups
384813|NCT01027598|B2|Baseline|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
384814|NCT01027598|B1|Baseline|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
384815|NCT01027598|P2|Participant Flow|Erlotinib + Placebo|"Erlotinib: 150 mg orally daily~Placebo: orally daily"
384816|NCT01027598|P1|Participant Flow|Erlotinib + Pazopanib|"Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
384817|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
384818|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
384819|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
384820|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
384821|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
384822|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
384823|NCT01027598|E2|Reported Event|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
384824|NCT01027598|E1|Reported Event|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
384825|NCT01027468|B1|Baseline|Group 1|3 year follow-up of intravitreal application of bevacizumab
384826|NCT01027468|P1|Participant Flow|Group 1|3 year follow-up of patients with intravitreal application of bevacizumab
384827|NCT01027468|O1|Outcome|Group 1|3 year follow-up of intravitreal application of bevacizumab
384828|NCT01027468|E1|Reported Event|Group 1|3 year follow-up of intravitreal application of bevacizumab
384829|NCT01027416|B3|Baseline|Total|Total of all reporting groups
384830|NCT01027416|B2|Baseline|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
384831|NCT01027416|B1|Baseline|No Intervention|No Intervention: Standard of care
384832|NCT01027416|P2|Participant Flow|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
384833|NCT01027416|P1|Participant Flow|No Intervention|No Intervention: Standard of care
384834|NCT01027416|O2|Outcome|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
384835|NCT01027416|O1|Outcome|No Intervention|No Intervention: Standard of care
384836|NCT01027416|O2|Outcome|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
384837|NCT01027416|O1|Outcome|No Intervention|No Intervention: Standard of care
384838|NCT01027416|E2|Reported Event|Tamoxifen|"Tamoxifen 20 mg orally 1x/day for 4 weeks~Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks"
384839|NCT01027416|E1|Reported Event|No Intervention|No Intervention: Standard of care
384840|NCT01027364|B5|Baseline|Total|Total of all reporting groups
384841|NCT01027364|B4|Baseline|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
385183|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
384842|NCT01027364|B3|Baseline|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384843|NCT01027364|B2|Baseline|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384844|NCT01027364|B1|Baseline|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384845|NCT01027364|P4|Participant Flow|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384846|NCT01027364|P3|Participant Flow|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384847|NCT01027364|P2|Participant Flow|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384848|NCT01027364|P1|Participant Flow|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384849|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384850|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384851|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384852|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384853|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384854|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384880|NCT01027364|O4|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384855|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384856|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384857|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384858|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384859|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384860|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384861|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384881|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384882|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384862|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384863|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384864|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384865|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384866|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384867|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384868|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384869|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384870|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
396538|NCT01000285|O1|Outcome|Patient A (Responder) Pre-Therapy|
384871|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384872|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384873|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384874|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384875|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384876|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384877|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
384878|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384879|NCT01027364|O5|Outcome|Total|All participants from Arms 1-4
384883|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384884|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384885|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384886|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384887|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384888|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
384889|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
384890|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
384891|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
384892|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
384893|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
384894|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384895|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384896|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384897|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384898|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384899|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384946|NCT01027351|P3|Participant Flow|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384900|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384901|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384902|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384903|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384904|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384905|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384906|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384907|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384908|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384909|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384910|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384911|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384912|NCT01027364|O1|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384927|NCT01027364|O3|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384913|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384914|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384915|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384916|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384917|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384918|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384919|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384920|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384921|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384922|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384923|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384924|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384925|NCT01027364|O5|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
384926|NCT01027364|O4|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
397050|NCT00999141|O3|Outcome|Somewhat Satisfied|
384928|NCT01027364|O2|Outcome|Arm 1: Weekly Prophylaxis-rFIXFc|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384929|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis-BeneFIX|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384930|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384931|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384932|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384933|NCT01027364|E3|Reported Event|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
384934|NCT01027364|E2|Reported Event|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
384935|NCT01027364|E1|Reported Event|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
384936|NCT01027351|B7|Baseline|Total|Total of all reporting groups
384937|NCT01027351|B6|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384938|NCT01027351|B5|Baseline|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384939|NCT01027351|B4|Baseline|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384940|NCT01027351|B3|Baseline|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384941|NCT01027351|B2|Baseline|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
384942|NCT01027351|B1|Baseline|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
384943|NCT01027351|P6|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384944|NCT01027351|P5|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384945|NCT01027351|P4|Participant Flow|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
385184|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
384947|NCT01027351|P2|Participant Flow|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
384948|NCT01027351|P1|Participant Flow|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
384949|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384950|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384951|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384952|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384953|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384954|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384955|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
384956|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
384957|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384958|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384959|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384960|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384961|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384962|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384963|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
384964|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
384965|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384966|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384967|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384968|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384969|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
384970|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
384971|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384972|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384973|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384974|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384975|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
384976|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
384977|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384978|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384979|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
385360|NCT01026402|B8|Baseline|Part A 125mg QD Tab Cont|Continuous QD dosing
384980|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384981|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
384982|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
384983|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384984|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384985|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384986|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384987|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
384988|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384989|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384990|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384991|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384992|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384993|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384994|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384995|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384996|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
384997|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
384998|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
384999|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
385000|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
385001|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385002|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
385003|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
385004|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385005|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
385006|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
385007|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385008|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
385009|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
385010|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385011|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
385012|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
385185|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
385013|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
385014|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
385015|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
385016|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
385017|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385018|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
385019|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
385020|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385021|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
385022|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
385023|NCT01027351|E6|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
385024|NCT01027351|E5|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385025|NCT01027351|E4|Reported Event|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
385026|NCT01027351|E3|Reported Event|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
385027|NCT01027351|E2|Reported Event|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
385028|NCT01027351|E1|Reported Event|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
385029|NCT01027286|B3|Baseline|Total|Total of all reporting groups
385030|NCT01027286|B2|Baseline|Control|No Vitagel used during primary total knee arthroplasty
385031|NCT01027286|B1|Baseline|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385032|NCT01027286|P2|Participant Flow|Control|No Vitagel used during primary total knee arthroplasty
385033|NCT01027286|P1|Participant Flow|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385034|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
385035|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385036|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
385037|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385038|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
385039|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385040|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
385041|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385042|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
385043|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385044|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
385045|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385046|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
385047|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385048|NCT01027286|E2|Reported Event|Control|No Vitagel used during primary total knee arthroplasty
385049|NCT01027286|E1|Reported Event|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
385050|NCT01027273|B3|Baseline|Total|Total of all reporting groups
385051|NCT01027273|B2|Baseline|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385052|NCT01027273|B1|Baseline|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385053|NCT01027273|P2|Participant Flow|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385054|NCT01027273|P1|Participant Flow|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385055|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385056|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385057|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385058|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385059|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385060|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385061|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385062|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385063|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385064|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385065|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385066|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385067|NCT01027273|E2|Reported Event|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
385068|NCT01027273|E1|Reported Event|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
385069|NCT01027195|B3|Baseline|Total|Total of all reporting groups
385070|NCT01027195|B2|Baseline|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385071|NCT01027195|B1|Baseline|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385072|NCT01027195|P2|Participant Flow|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385073|NCT01027195|P1|Participant Flow|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385074|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385075|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385076|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385077|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385078|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385079|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385080|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385081|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385082|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385083|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385084|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385085|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385086|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385087|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385088|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385089|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385090|NCT01027195|E2|Reported Event|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
385091|NCT01027195|E1|Reported Event|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
385092|NCT01027000|B1|Baseline|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
385117|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385118|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385119|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
397051|NCT00999141|O2|Outcome|A Little Satisfied|
385093|NCT01027000|P1|Participant Flow|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
385094|NCT01027000|O1|Outcome|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
385095|NCT01027000|E1|Reported Event|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
385096|NCT01026974|B5|Baseline|Total|Total of all reporting groups
385097|NCT01026974|B4|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385098|NCT01026974|B3|Baseline|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385099|NCT01026974|B2|Baseline|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385100|NCT01026974|B1|Baseline|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385101|NCT01026974|P4|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385102|NCT01026974|P3|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385103|NCT01026974|P2|Participant Flow|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385104|NCT01026974|P1|Participant Flow|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385105|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385106|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385107|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385108|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385109|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385110|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385111|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385112|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385113|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385114|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385115|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385116|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385120|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385121|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385122|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385123|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385124|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385125|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385126|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385127|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385128|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385129|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385130|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385131|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385132|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385133|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385134|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385135|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385136|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385137|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385138|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385139|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385140|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385141|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385142|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385143|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385144|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385145|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385146|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385147|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385148|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385149|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385150|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385151|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385182|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
385152|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385153|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385154|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385155|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385156|NCT01026974|E4|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
385157|NCT01026974|E3|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
385158|NCT01026974|E2|Reported Event|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
385159|NCT01026974|E1|Reported Event|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
385160|NCT01026948|B1|Baseline|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
385161|NCT01026948|P1|Participant Flow|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
385162|NCT01026948|O1|Outcome|Acceptability|Maternal views were assessed using semi-structured diaries
385163|NCT01026948|O1|Outcome|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
385164|NCT01026948|E1|Reported Event|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
385165|NCT01026909|B3|Baseline|Total|Total of all reporting groups
385166|NCT01026909|B2|Baseline|Control|observation
385167|NCT01026909|B1|Baseline|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
385168|NCT01026909|P2|Participant Flow|Control|Observation
385169|NCT01026909|P1|Participant Flow|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
385170|NCT01026909|O2|Outcome|Control|Observation
385171|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
385172|NCT01026909|O2|Outcome|Control|Observation
385173|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
385174|NCT01026909|E2|Reported Event|Control|Observation
385175|NCT01026909|E1|Reported Event|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
385176|NCT01026844|B3|Baseline|Total|Total of all reporting groups
385177|NCT01026844|B2|Baseline|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
385178|NCT01026844|B1|Baseline|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
385179|NCT01026844|P2|Participant Flow|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
385180|NCT01026844|P1|Participant Flow|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
385181|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
385186|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
385187|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
385188|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
385189|NCT01026844|E2|Reported Event|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
385190|NCT01026844|E1|Reported Event|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
385191|NCT01026831|B3|Baseline|Total|Total of all reporting groups
385192|NCT01026831|B2|Baseline|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
385193|NCT01026831|B1|Baseline|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
385194|NCT01026831|P2|Participant Flow|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
385195|NCT01026831|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
385196|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
385197|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
385198|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
385199|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
385200|NCT01026831|E2|Reported Event|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
385201|NCT01026831|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
385202|NCT01026818|B4|Baseline|Total|Total of all reporting groups
385203|NCT01026818|B3|Baseline|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385204|NCT01026818|B2|Baseline|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385205|NCT01026818|B1|Baseline|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385206|NCT01026818|P4|Participant Flow|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385207|NCT01026818|P3|Participant Flow|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385208|NCT01026818|P2|Participant Flow|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385209|NCT01026818|P1|Participant Flow|Screen - BNSRP|BNSRP surgery during Screening Period.
385210|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385211|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385212|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385213|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385214|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385215|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385216|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385217|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385218|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385219|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385302|NCT01026493|B7|Baseline|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385220|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385221|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385222|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385223|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385224|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385225|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385226|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385227|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385228|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385229|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385230|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385231|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385232|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385233|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385234|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385235|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385236|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385237|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385238|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385239|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385240|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385241|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385242|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385243|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385244|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385245|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385246|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385247|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385248|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385249|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385250|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385251|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385252|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385253|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385254|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385255|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385256|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385257|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385258|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385259|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385260|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385261|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385262|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385263|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385264|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385265|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385266|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385267|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385268|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385269|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385270|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385271|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385272|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385273|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385274|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385275|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385276|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385277|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385278|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385279|NCT01026818|E7|Reported Event|Placebo (Open-Label Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385280|NCT01026818|E6|Reported Event|Tadalfil 20 mg PRN (Open-Label Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385281|NCT01026818|E5|Reported Event|Tadalafil 5 mg OaD (Open-Label Period)|Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
385282|NCT01026818|E4|Reported Event|Placebo (Double-Blind Period/Washout Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
385283|NCT01026818|E3|Reported Event|Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
385284|NCT01026818|E2|Reported Event|Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
385285|NCT01026818|E1|Reported Event|Screen - BNSRP|Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.
385286|NCT01026805|B1|Baseline|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385287|NCT01026805|P1|Participant Flow|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385288|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385289|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385290|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385291|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385292|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385293|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385294|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385295|NCT01026805|E1|Reported Event|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
385296|NCT01026792|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
385297|NCT01026792|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
385298|NCT01026792|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
385299|NCT01026792|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
385300|NCT01026493|B9|Baseline|Total|Total of all reporting groups
385301|NCT01026493|B8|Baseline|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385303|NCT01026493|B6|Baseline|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385304|NCT01026493|B5|Baseline|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
385305|NCT01026493|B4|Baseline|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385306|NCT01026493|B3|Baseline|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
385307|NCT01026493|B2|Baseline|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
385308|NCT01026493|B1|Baseline|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
385309|NCT01026493|P8|Participant Flow|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385310|NCT01026493|P7|Participant Flow|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385311|NCT01026493|P6|Participant Flow|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385312|NCT01026493|P5|Participant Flow|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
385313|NCT01026493|P4|Participant Flow|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385314|NCT01026493|P3|Participant Flow|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
385315|NCT01026493|P2|Participant Flow|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
385316|NCT01026493|P1|Participant Flow|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
385317|NCT01026493|O4|Outcome|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385318|NCT01026493|O3|Outcome|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385319|NCT01026493|O2|Outcome|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385320|NCT01026493|O1|Outcome|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
385321|NCT01026493|O4|Outcome|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385322|NCT01026493|O3|Outcome|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385323|NCT01026493|O2|Outcome|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385324|NCT01026493|O1|Outcome|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
385325|NCT01026493|O4|Outcome|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385326|NCT01026493|O3|Outcome|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385327|NCT01026493|O2|Outcome|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385328|NCT01026493|O1|Outcome|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
385329|NCT01026493|O4|Outcome|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385330|NCT01026493|O3|Outcome|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
385331|NCT01026493|O2|Outcome|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
385332|NCT01026493|O1|Outcome|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
385333|NCT01026493|E8|Reported Event|Phase II: Arm 2/BEV-FAILURE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385334|NCT01026493|E7|Reported Event|Phase II: Arm 1/BEV-FAILURE|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385335|NCT01026493|E6|Reported Event|Phase II: Arm 2/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 150 mg x 5 days
385336|NCT01026493|E5|Reported Event|Phase II: Arm 1/BEV-NAIVE|ABT-888 40 mg x 5 days plus temozolomide 75 mg x 5 days
385337|NCT01026493|E4|Reported Event|Phase I: Dose Level 3|ABT-888 40 mg x 21 days plus temozolomide 75 mg x 21 days
385338|NCT01026493|E3|Reported Event|Phase I: Dose Level 2b|ABT-888 20 mg x 21 days plus temozolomide 75 mg x 21 days
385339|NCT01026493|E2|Reported Event|Phase I: Dose Level 2a|ABT-888 40 mg x 21 days plus temozolomide 60 mg x 21 days
385340|NCT01026493|E1|Reported Event|Phase I: Dose Level 1|ABT-888 20 mg x 21 days plus temozolomide 60 mg x 21 days
385341|NCT01026454|B3|Baseline|Total|Total of all reporting groups
385342|NCT01026454|B2|Baseline|Valacyclovir Then Acyclovir|valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks
385343|NCT01026454|B1|Baseline|Acyclovir Then Valacyclovir|acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks
385344|NCT01026454|P2|Participant Flow|Valacyclovir Then Acyclovir|Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
385345|NCT01026454|P1|Participant Flow|Acyclovir Then Valacyclovir|Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)
385346|NCT01026454|O2|Outcome|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
385347|NCT01026454|O1|Outcome|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
385348|NCT01026454|E2|Reported Event|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
385349|NCT01026454|E1|Reported Event|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
385350|NCT01026402|B18|Baseline|Total|Total of all reporting groups
385351|NCT01026402|B17|Baseline|Part A 100mg BD Soln Cont|Continuous BD dosing
385352|NCT01026402|B16|Baseline|Part A 70mg BD Soln Cont|Continuous BD dosing
385353|NCT01026402|B15|Baseline|Part B 170mg BD Tab Int|Intermittent BD dosing
385354|NCT01026402|B14|Baseline|Part B 125mg BD Tab Int|Intermittent BD dosing
385355|NCT01026402|B13|Baseline|Part A 225mg BD Tab Int|Intermittent BD dosing
385356|NCT01026402|B12|Baseline|Part A 170mg BD Tab Int|Intermittent BD dosing
385357|NCT01026402|B11|Baseline|Part A 125mg BD Tab Int|Intermittent BD dosing
385358|NCT01026402|B10|Baseline|Part A 100mg BD Tab Int|Intermittent BD dosing
385359|NCT01026402|B9|Baseline|Part A 175mg QD Tab Cont|Continuous QD dosing
385361|NCT01026402|B7|Baseline|Part A 100mg QD Tab Cont|Continuous QD dosing
385362|NCT01026402|B6|Baseline|Part A 125mg QD Soln Cont|Continuous QD dosing
385363|NCT01026402|B5|Baseline|Part A 75mg QD Soln Cont|Continuous QD dosing
385364|NCT01026402|B4|Baseline|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385365|NCT01026402|B3|Baseline|Part B 50mg BD Soln Cont|Continuous BD dosing
385366|NCT01026402|B2|Baseline|Part A 50mg BD Soln Cont|Continuous BD dosing
385367|NCT01026402|B1|Baseline|Part A 25mg BD Soln Cont|Continuous BD dosing
385368|NCT01026402|P17|Participant Flow|Part A 100mg BD Soln Cont|Continuous BD dosing
385369|NCT01026402|P16|Participant Flow|Part A 70mg BD Soln Cont|Continuous BD dosing
385370|NCT01026402|P15|Participant Flow|Part B 170mg BD Tab Int|Intermittent BD dosing
385371|NCT01026402|P14|Participant Flow|Part B 125mg BD Tab Int|Intermittent BD dosing
385372|NCT01026402|P13|Participant Flow|Part A 225mg BD Tab Int|Intermittent BD dosing
385373|NCT01026402|P12|Participant Flow|Part A 170mg BD Tab Int|Intermittent BD dosing
385374|NCT01026402|P11|Participant Flow|Part A 125mg BD Tab Int|Intermittent BD dosing
385375|NCT01026402|P10|Participant Flow|Part A 100mg BD Tab Int|Intermittent BD dosing
385376|NCT01026402|P9|Participant Flow|Part A 175mg QD Tab Cont|Continuous QD dosing
385377|NCT01026402|P8|Participant Flow|Part A 125mg QD Tab Cont|Continuous QD dosing
385378|NCT01026402|P7|Participant Flow|Part A 100mg QD Tab Cont|Continuous QD dosing
385379|NCT01026402|P6|Participant Flow|Part A 125mg QD Soln Cont|Continuous QD dosing
385380|NCT01026402|P5|Participant Flow|Part A 75mg QD Soln Cont|Continuous QD dosing
385381|NCT01026402|P4|Participant Flow|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385382|NCT01026402|P3|Participant Flow|Part B 50mg BD Soln Cont|Continuous BD dosing
385383|NCT01026402|P2|Participant Flow|Part A 50mg BD Soln Cont|Continuous BD dosing
385384|NCT01026402|P1|Participant Flow|Part A 25mg BD Soln Cont|Continuous BD dosing
385385|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385386|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385387|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385388|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385389|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385390|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385391|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385392|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385393|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385394|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385395|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385396|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385397|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385398|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385399|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385400|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385401|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385402|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385403|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385404|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385405|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385406|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385407|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385408|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385409|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385410|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385411|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385412|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385413|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385414|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385415|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385416|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385417|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385418|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385419|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385420|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385421|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385422|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385423|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385424|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385425|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385426|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385427|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385428|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385429|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385430|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385431|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385432|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385433|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385434|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385435|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385436|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385437|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385438|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385439|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385440|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385441|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385442|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385443|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385444|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385445|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385446|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385447|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385448|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385449|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385450|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385451|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385452|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385453|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385454|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385455|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385456|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385457|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385458|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385459|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385460|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385461|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385462|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385463|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385464|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385465|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385466|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385467|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385468|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385469|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385470|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385471|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385472|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385473|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385474|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385475|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385476|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385477|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385478|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385479|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385480|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385481|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385482|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385483|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385484|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385485|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385486|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385487|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385488|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385489|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385490|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385491|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385492|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385493|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385494|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385495|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385496|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385497|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385498|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385499|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385500|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385501|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385502|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385503|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385504|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385505|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385506|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385507|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385508|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385509|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385510|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385511|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385512|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385513|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385514|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385515|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385516|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385517|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385518|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385519|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385520|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385521|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385522|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385523|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385524|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385525|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385526|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385527|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385528|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385529|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385530|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385531|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385532|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385533|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385534|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385535|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385536|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385537|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385538|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385539|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385540|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385541|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385542|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385543|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385544|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385545|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385546|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385547|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385548|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385549|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385550|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385551|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385552|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385553|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385554|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385555|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385556|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385557|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385558|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385559|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385560|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385561|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385562|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385563|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385564|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385565|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385566|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385567|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385568|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385569|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385570|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385571|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385572|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385573|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385574|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385575|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385576|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385577|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385578|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385579|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385580|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385581|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385582|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385583|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385584|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385585|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385586|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385587|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385588|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385589|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385590|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385591|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385592|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385593|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385594|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385595|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385596|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385597|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385598|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385599|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385600|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385601|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385602|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385603|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385604|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385605|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385606|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385607|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385608|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385609|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385610|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385611|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385612|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385613|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385614|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385615|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385616|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385617|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385618|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385619|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385620|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
385621|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
385622|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385623|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385624|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385625|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385626|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385627|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385628|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385629|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385630|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385631|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385632|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385633|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385634|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385635|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385636|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385637|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385638|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385639|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385640|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385641|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385642|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385643|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385644|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385645|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385646|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385647|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385648|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385649|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385650|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385651|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385652|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385653|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385654|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385655|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385656|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
385657|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
385658|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
385659|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
385660|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
385661|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
385662|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
385663|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
385664|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
385665|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
385666|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
385667|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
385668|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
385669|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
385670|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
385671|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
385672|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
385673|NCT01026402|E18|Reported Event|Part B - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
385674|NCT01026402|E17|Reported Event|Part B - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
385675|NCT01026402|E16|Reported Event|Part B - AZD2014 BD 50 mg Tablet Fed/Fasted|Continuous BD dosing
385676|NCT01026402|E15|Reported Event|Part B - AZD2014 50 mg BD Tablet Fasted/Fed|Continuous BD dosing
385677|NCT01026402|E14|Reported Event|Part B - AZD2014 50 mg BD Solution|Continuous BD dosing
385678|NCT01026402|E13|Reported Event|Part A - Intermittent AZD2014 225 mg BD Tablet|Intermittent BD dosing
385679|NCT01026402|E12|Reported Event|Part A - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
385680|NCT01026402|E11|Reported Event|Part A - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
385681|NCT01026402|E10|Reported Event|Part A - Intermittent AZD2014 100 mg BD Tablet|Intermittent BD dosing
385682|NCT01026402|E9|Reported Event|Part A - AZD2014 75 mg QD Solution|Continuous QD dosing
385683|NCT01026402|E8|Reported Event|Part A - AZD2014 70 mg BD Solution|Continuous BD dosing
385684|NCT01026402|E7|Reported Event|Part A - AZD2014 50 mg BD Solution|Continuous BD dosing
385685|NCT01026402|E6|Reported Event|Part A - AZD2014 25 mg BD Solution|Continuous BD dosing
385686|NCT01026402|E5|Reported Event|Part A - AZD2014 175 mg QD Tablet|Continuous QD dosing
385687|NCT01026402|E4|Reported Event|Part A - AZD2014 125 mg QD Tablet|Continuous QD dosing
385688|NCT01026402|E3|Reported Event|Part A - AZD2014 125 mg QD Solution|Continous QD dosing
385689|NCT01026402|E2|Reported Event|Part A - AZD2014 100 mg QD Tablet|Continuous QD dosing
385690|NCT01026402|E1|Reported Event|Part A - AZD2014 100 mg BD Solution|Continuous BD dosing
385691|NCT01026389|B3|Baseline|Total|Total of all reporting groups
385692|NCT01026389|B2|Baseline|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
385693|NCT01026389|B1|Baseline|Gadovist|Patient received contrast-enhanced MRA with Gadovist
385694|NCT01026389|P2|Participant Flow|Dotarem|Patients received contrast-enhanced MRA with Dotarem
385695|NCT01026389|P1|Participant Flow|Gadovist|Patient received contrast-enhanced MRA with Gadovist
385696|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
385697|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
385698|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
385699|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
385700|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
385701|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
385702|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
385703|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
385704|NCT01026389|E2|Reported Event|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
385705|NCT01026389|E1|Reported Event|Gadovist|Patient received contrast-enhanced MRA with Gadovist
385706|NCT01026324|B4|Baseline|Total|Total of all reporting groups
385707|NCT01026324|B3|Baseline|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
385708|NCT01026324|B2|Baseline|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
385709|NCT01026324|B1|Baseline|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
385710|NCT01026324|P3|Participant Flow|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
385711|NCT01026324|P2|Participant Flow|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
385712|NCT01026324|P1|Participant Flow|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
385713|NCT01026324|O3|Outcome|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
385714|NCT01026324|O2|Outcome|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
385715|NCT01026324|O1|Outcome|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
385716|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
385717|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
385718|NCT01026324|E3|Reported Event|Dose Level 3 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 30 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
385719|NCT01026324|E2|Reported Event|Dose Level 2 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 20 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
385720|NCT01026324|E1|Reported Event|Dose Level 1 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 10 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
385721|NCT01026220|B1|Baseline|INDUCTION THERAPY (ABVE-PC)|All Patients
385722|NCT01026220|P3|Participant Flow|REGIMEN II (SER)|Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
385723|NCT01026220|P2|Participant Flow|REGIMEN I (RER)|Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
385724|NCT01026220|P1|Participant Flow|INDUCTION THERAPY (ABVE-PC)|All Patients
385725|NCT01026220|O3|Outcome|Group 3|Regimen II
385726|NCT01026220|O2|Outcome|Group 2|Regimen I
385727|NCT01026220|O1|Outcome|Group 1|All Patients
385728|NCT01026220|O1|Outcome|Group 1|All Patients
385729|NCT01026220|O2|Outcome|Group 3|Regimen II
385730|NCT01026220|O1|Outcome|Group 2|Regimen I
385731|NCT01026220|O3|Outcome|Group 7|no risk-adapted radiation therapy
385732|NCT01026220|O2|Outcome|Group 6|risk-adapted radiation therapy
385733|NCT01026220|O1|Outcome|Group 1|All Patients
385734|NCT01026220|O3|Outcome|Group 5|RER PET-1 negative
385735|NCT01026220|O2|Outcome|Group 4|RER PET-1 positive
385736|NCT01026220|O1|Outcome|Group 1|All Patients
385737|NCT01026220|O2|Outcome|Group 3|Regimen II
385738|NCT01026220|O1|Outcome|Group 2|Regimen 1
385739|NCT01026220|O1|Outcome|Group 1|All Patients
385740|NCT01026220|O1|Outcome|Group 1|All Patients
385741|NCT01026220|O1|Outcome|Group 1|All Patients
385742|NCT01026220|E3|Reported Event|Group 3|Regimen II
385743|NCT01026220|E2|Reported Event|Group 2|Regimen I
385744|NCT01026220|E1|Reported Event|Group 1|All Patients
385745|NCT01026194|B3|Baseline|Total|Total of all reporting groups
385746|NCT01026194|B2|Baseline|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385747|NCT01026194|B1|Baseline|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385748|NCT01026194|P2|Participant Flow|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385749|NCT01026194|P1|Participant Flow|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385750|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385751|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385752|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385753|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385754|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385755|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385756|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
385757|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
386193|NCT01024738|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
385758|NCT01026194|E4|Reported Event|Teneli/Teneli + Pio (Data Through Week 52)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
385759|NCT01026194|E3|Reported Event|Placebo/Teneli + Pio (Data From Week 12 to Week 52)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
385760|NCT01026194|E2|Reported Event|Teneli/Teneli + Pio (Data Through Week 12)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
385761|NCT01026194|E1|Reported Event|Placebo/Teneli + Pio (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
385762|NCT01026181|B4|Baseline|Total|Total of all reporting groups
385763|NCT01026181|B3|Baseline|LAGB|Laparoscopic Adjustable Gastric Banding
385764|NCT01026181|B2|Baseline|LRYGB|Laparoscopic Roux-en-Y Gastric Bypass
385765|NCT01026181|B1|Baseline|LSG (Lap SG)|Laparoscopic Sleeve Gastrectomy
385766|NCT01026181|P3|Participant Flow|Laparoscopic Adjustable Gastric Banding|Patients who had Laparoscopic Adjustable Gastric Banding for their morbid obesity
385767|NCT01026181|P2|Participant Flow|Laparoscopic Roux-en-Y Gastric Bypass|Patients who had Laparoscopic Roux-en-Y Gastric Bypass for their morbid obesity
385768|NCT01026181|P1|Participant Flow|Laparoscopic Sleeve Gastrectomy|Patient who had Laparoscopic Sleeve Gastrectomy for their morbid obesity
385769|NCT01026181|O3|Outcome|Laparoscopic Adjustable Gastric Banding|
385770|NCT01026181|O2|Outcome|Laparoscopic Roux-en-Y Gastric Bypass|
385771|NCT01026181|O1|Outcome|Laparoscopic Sleeve Gastrectomy|
385772|NCT01026181|O3|Outcome|Laparoscopic Adjustable Gastric Banding|
385773|NCT01026181|O2|Outcome|Laparoscopic Roux-en-Y Gastric Bypass|
385774|NCT01026181|O1|Outcome|Laparoscopic Sleeve Gastrectomy|
385775|NCT01026181|E3|Reported Event|Laparoscopic Adjustable Gastric Banding|
385776|NCT01026181|E2|Reported Event|Laparoscopic Roux-en-Y Gastric Bypass|
385777|NCT01026181|E1|Reported Event|Laparoscopic Sleeve Gastrectomy|
385778|NCT01026142|B3|Baseline|Total|Total of all reporting groups
385779|NCT01026142|B2|Baseline|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks~pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
385780|NCT01026142|B1|Baseline|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
385781|NCT01026142|P2|Participant Flow|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385782|NCT01026142|P1|Participant Flow|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385783|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385784|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385785|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385786|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385787|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385788|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385789|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385790|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385791|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385792|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385793|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385794|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385795|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385796|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385797|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385798|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385799|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks~pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
385800|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
385801|NCT01026142|E2|Reported Event|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
385802|NCT01026142|E1|Reported Event|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
385803|NCT01026103|B1|Baseline|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
385804|NCT01026103|P1|Participant Flow|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
385805|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
385806|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
385807|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
385808|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
385809|NCT01026103|E1|Reported Event|Tri Staple|This is a single arm study.
385810|NCT01026038|B4|Baseline|Total|Total of all reporting groups
385811|NCT01026038|B3|Baseline|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385812|NCT01026038|B2|Baseline|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385813|NCT01026038|B1|Baseline|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385814|NCT01026038|P3|Participant Flow|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385815|NCT01026038|P2|Participant Flow|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385816|NCT01026038|P1|Participant Flow|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385817|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385818|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385819|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385820|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385821|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385822|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385823|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385824|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385825|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385826|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
386194|NCT01024738|O1|Outcome|Fluoride Toothpaste|negative control toothpaste
385827|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385828|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385829|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385830|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385831|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385832|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385833|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385834|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385835|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385836|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385837|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385838|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385839|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385840|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385841|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385842|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385843|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385844|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385845|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385846|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385847|NCT01026038|E3|Reported Event|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
385848|NCT01026038|E2|Reported Event|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
385849|NCT01026038|E1|Reported Event|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
385850|NCT01026012|B1|Baseline|Combined Stress Group|patient's were monitor for approximately 30 minutes following regadenoson infusion
385851|NCT01026012|P1|Participant Flow|Combined Stress Group|Subjects had a sub-maximal symptom limited stress test (<85% MPHR)then immediately followed by pharmological stress test with the infusion of regadenoson 400mcg infused over 10-20 seconds.
385852|NCT01026012|O1|Outcome|Combined Stress Group|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.
385853|NCT01026012|E1|Reported Event|Safety|patient's were monitor for approximately 30 minutes following regadenoson infusion
385854|NCT01025843|B11|Baseline|Total|Total of all reporting groups
385855|NCT01025843|B10|Baseline|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
385856|NCT01025843|B9|Baseline|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385857|NCT01025843|B8|Baseline|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
385858|NCT01025843|B7|Baseline|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
397052|NCT00999141|O1|Outcome|Not at All Satisfied|
385859|NCT01025843|B6|Baseline|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385860|NCT01025843|B5|Baseline|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
385861|NCT01025843|B4|Baseline|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
385862|NCT01025843|B3|Baseline|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385863|NCT01025843|B2|Baseline|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
385864|NCT01025843|B1|Baseline|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
385865|NCT01025843|P10|Participant Flow|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
385866|NCT01025843|P9|Participant Flow|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385867|NCT01025843|P8|Participant Flow|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
385868|NCT01025843|P7|Participant Flow|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385869|NCT01025843|P6|Participant Flow|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385870|NCT01025843|P5|Participant Flow|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
385871|NCT01025843|P4|Participant Flow|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
385872|NCT01025843|P3|Participant Flow|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385873|NCT01025843|P2|Participant Flow|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
385874|NCT01025843|P1|Participant Flow|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
385875|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
385876|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
385877|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
385878|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
385879|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
385880|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
385881|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
385882|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
385883|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
385884|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
385885|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
385886|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
385887|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
385888|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
385889|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
385890|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
385891|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
386707|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
385892|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
385893|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
385894|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
385895|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
385896|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
385897|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
385898|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
385899|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
385900|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
385901|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
385902|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
385903|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
385904|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
385905|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
385906|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
385907|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
385908|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
385909|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
385910|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
385911|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
385912|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
385913|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
385914|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
385915|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
385916|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
385917|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
385918|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
385919|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
385920|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
385921|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
385922|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
385923|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
385924|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
385925|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
385926|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
385927|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
385928|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
385929|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
385930|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
385931|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
385932|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
385933|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
385934|NCT01025843|E13|Reported Event|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
385935|NCT01025843|E12|Reported Event|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
385936|NCT01025843|E11|Reported Event|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
386708|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
385937|NCT01025843|E10|Reported Event|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
385938|NCT01025843|E9|Reported Event|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
385939|NCT01025843|E8|Reported Event|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
385940|NCT01025843|E7|Reported Event|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
385941|NCT01025843|E6|Reported Event|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
385942|NCT01025843|E5|Reported Event|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
385943|NCT01025843|E4|Reported Event|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
385944|NCT01025843|E3|Reported Event|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
385945|NCT01025843|E2|Reported Event|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
385946|NCT01025843|E1|Reported Event|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
385947|NCT01025830|B1|Baseline|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
385948|NCT01025830|P2|Participant Flow|Brand (Zerit/Epivir/Viramune) to Generic (Triomune)|started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)
385949|NCT01025830|P1|Participant Flow|Generic (Triomune) to Brand (Zerit/Epivir/Viramune)|Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
385950|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
385951|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
385952|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
385953|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
385954|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
385955|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
385956|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
385957|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
385958|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
385959|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
385960|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
385961|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
385962|NCT01025830|E3|Reported Event|Brand to Generic|started with brand formulation then switched to generic formulation
385963|NCT01025830|E2|Reported Event|Generic to Brand|Started with generic formulation then switched to brand formulation
385964|NCT01025830|E1|Reported Event|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
385965|NCT01025817|B3|Baseline|Total|Total of all reporting groups
385966|NCT01025817|B2|Baseline|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385967|NCT01025817|B1|Baseline|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385968|NCT01025817|P2|Participant Flow|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385969|NCT01025817|P1|Participant Flow|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385970|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385971|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385972|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385973|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385974|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385975|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385976|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385977|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385978|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385979|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385980|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
386008|NCT01025336|B3|Baseline|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386163|NCT01024959|E2|Reported Event|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
397053|NCT00999141|O5|Outcome|Very Satisfied|
385981|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385982|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385983|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385984|NCT01025817|E2|Reported Event|Mycophenolate Mofetil and Standard Dose Tacrolimus|The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
385985|NCT01025817|E1|Reported Event|Everolimus and Low Dose Tacrolimus|Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
385986|NCT01025635|B3|Baseline|Total|Total of all reporting groups
385987|NCT01025635|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
385988|NCT01025635|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
385989|NCT01025635|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
385990|NCT01025635|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
385991|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
385992|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
385993|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
385994|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
385995|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
385996|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
385997|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
385998|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
385999|NCT01025635|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
386000|NCT01025635|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
386001|NCT01025492|B1|Baseline|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
386002|NCT01025492|P1|Participant Flow|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
386003|NCT01025492|O1|Outcome|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
386004|NCT01025492|E1|Reported Event|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
386005|NCT01025336|B6|Baseline|Total|Total of all reporting groups
386006|NCT01025336|B5|Baseline|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386007|NCT01025336|B4|Baseline|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386091|NCT01025271|O1|Outcome|PK Sampling|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
386092|NCT01025271|O1|Outcome|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
386009|NCT01025336|B2|Baseline|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386010|NCT01025336|B1|Baseline|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386011|NCT01025336|P5|Participant Flow|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386012|NCT01025336|P4|Participant Flow|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386013|NCT01025336|P3|Participant Flow|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386014|NCT01025336|P2|Participant Flow|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386015|NCT01025336|P1|Participant Flow|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386016|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386017|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386018|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386019|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386020|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (6115A1-3010 NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
386021|NCT01025336|O1|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
386022|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386023|NCT01025336|O2|Outcome|13vPnC (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
386024|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386025|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386026|NCT01025336|O2|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and either 13vPnC or 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) (both 13vPnC/13vPnC and 13vPnC/23vPS dose groups)
386027|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386028|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2).
386029|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386030|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386031|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386032|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386033|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386034|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386035|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386036|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386037|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386038|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386039|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386040|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386041|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386042|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386043|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386044|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386045|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386046|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
397054|NCT00999141|O4|Outcome|Moderately Satisfied|
386047|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386048|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386049|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386050|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386051|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386052|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386053|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386054|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2)
386055|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386056|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386057|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386058|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386059|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386060|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPs Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386061|NCT01025336|E5|Reported Event|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386062|NCT01025336|E4|Reported Event|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386063|NCT01025336|E3|Reported Event|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386064|NCT01025336|E2|Reported Event|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
386093|NCT01025271|E1|Reported Event|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
386094|NCT01025232|B3|Baseline|Total|Total of all reporting groups
386164|NCT01024959|E1|Reported Event|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
386065|NCT01025336|E1|Reported Event|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
386066|NCT01025284|B4|Baseline|Total|Total of all reporting groups
386067|NCT01025284|B3|Baseline|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
386068|NCT01025284|B2|Baseline|Part B - 5 mg/m²/Day|5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386069|NCT01025284|B1|Baseline|Part A - 8 mg/m²/Day|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386070|NCT01025284|P3|Participant Flow|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
386071|NCT01025284|P2|Participant Flow|Part B - 5 mg/m²/Day|5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386072|NCT01025284|P1|Participant Flow|Part A - 8 mg/m²/Day|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386073|NCT01025284|O1|Outcome|Part B|5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386074|NCT01025284|O2|Outcome|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386075|NCT01025284|O1|Outcome|Part B - 5 mg/m²/Day|5 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386076|NCT01025284|O1|Outcome|Part A|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386077|NCT01025284|O2|Outcome|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
386078|NCT01025284|O1|Outcome|Part B - 5 mg/m²/Day|5 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386079|NCT01025284|O1|Outcome|Part A|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386080|NCT01025284|O1|Outcome|Part B|5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386081|NCT01025284|O1|Outcome|Part A|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386082|NCT01025284|O1|Outcome|Part B|5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386083|NCT01025284|O1|Outcome|Part A|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386084|NCT01025284|O1|Outcome|Part B|5 or 6 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386085|NCT01025284|O1|Outcome|Part A|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386086|NCT01025284|E3|Reported Event|Part B - 6 mg/m²/Day|6 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus G-CSF support given per local package insert beginning on Day 4 of each 21-day cycle.
386087|NCT01025284|E2|Reported Event|Part B - 5 mg/m²/Day|5 mg/m² of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, and 3 plus granulocyte colony-stimulating factor (G-CSF) support given per local package insert beginning on Day 4 of each 21-day cycle.
386088|NCT01025284|E1|Reported Event|Part A - 8 mg/m²/Day|8 milligrams per square meter (mg/m²) of LY2523355 per day based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of each 21-day cycle.
386089|NCT01025271|B1|Baseline|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
386090|NCT01025271|P1|Participant Flow|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
386095|NCT01025232|B2|Baseline|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386096|NCT01025232|B1|Baseline|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386097|NCT01025232|P2|Participant Flow|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386098|NCT01025232|P1|Participant Flow|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386099|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386100|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386101|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386102|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386103|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386104|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386105|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386106|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386107|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386108|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386109|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386110|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386111|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386112|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386113|NCT01025232|E2|Reported Event|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386114|NCT01025232|E1|Reported Event|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
386115|NCT01025193|B1|Baseline|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386116|NCT01025193|P1|Participant Flow|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was being used to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386117|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386118|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386119|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab: The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386120|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386121|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386122|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
397055|NCT00999141|O3|Outcome|Somewhat Satisfied|
386123|NCT01025193|O1|Outcome|Belimumab|"Belimumab will be administered intravenously at a dose of 10mg/kg on days 0, 14, 28 and every 28 days for up to 52 weeks to normalize alloantibody levels in sensitized patients awaiting kidney transplantation. Subjects who are not able to undergo transplantation before the end of the treatment period will have final follow-up evaluation 8 weeks after the last dose of belimumab is administered.~Belimumab: Belimumab is a fully human monoclonal antibody that recognizes and inhibits BLyS ®. BLyS ® is a B-lymphocyte stimulator protein which plays a role in the development of B lymphocyte cells into plasma B cells, which then produce antibodies that can sensitize a potential transplant recipient. At the time of this trial, belimumab was not yet FDA approved and was being studied in clinical trials for the treatment of systemic lupus erythematosus. Until this trial, it had not yet been used in the transplant setting."
386124|NCT01025193|E1|Reported Event|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the patient waiting for kidney transplant's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
386125|NCT01025154|B1|Baseline|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
386126|NCT01025154|P1|Participant Flow|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
386127|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
386128|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
386129|NCT01025154|E1|Reported Event|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
386130|NCT01025076|B1|Baseline|StomaphX|Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
386131|NCT01025076|P1|Participant Flow|StomaphX|
386132|NCT01025076|O1|Outcome|StomaphX|
386133|NCT01025076|E1|Reported Event|StomaphX|
386134|NCT01025037|B1|Baseline|Conexa|Rotator cuff repair using Conexa
386135|NCT01025037|P1|Participant Flow|Conexa|Rotator cuff repair using Conexa
386136|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
386137|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
386138|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
386139|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
386140|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
386141|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
386142|NCT01025037|E1|Reported Event|Conexa|Rotator cuff repair using Conexa
386143|NCT01024972|B3|Baseline|Total|Total of all reporting groups
386144|NCT01024972|B2|Baseline|Placebo|Equiosmolar volume (5% mannitol) every 6 hours for seven days.
386145|NCT01024972|B1|Baseline|Dantrolene|Intravenous Datrolene 1.25 mg/kg (includes 5% mannitol) every 6 hours for seven days.
386146|NCT01024972|P2|Participant Flow|Placebo|"Equiosmolar volume (5% Mannitol)~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
386147|NCT01024972|P1|Participant Flow|Dantrolene|"Dantrolene 1.25mg/kg IV every 6 hours x 7 days~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
386148|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
386149|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
386150|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
386151|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
386152|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days.
386153|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
386154|NCT01024972|E2|Reported Event|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
386155|NCT01024972|E1|Reported Event|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
386156|NCT01024959|B1|Baseline|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
386157|NCT01024959|P1|Participant Flow|Prostate Cancer Gene 3 (PCA3) Assay|PCA3 Assay : Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
386158|NCT01024959|O3|Outcome|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
386159|NCT01024959|O2|Outcome|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
386160|NCT01024959|O1|Outcome|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
386161|NCT01024959|E4|Reported Event|Subjects With no Biopsy Performed|
386162|NCT01024959|E3|Reported Event|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
386165|NCT01024946|B1|Baseline|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
386166|NCT01024946|P1|Participant Flow|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
386167|NCT01024946|O1|Outcome|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
386168|NCT01024946|E1|Reported Event|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
386169|NCT01024855|B1|Baseline|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
386170|NCT01024855|P1|Participant Flow|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
386171|NCT01024855|O2|Outcome|OptiFree|30 subjects, one eye received Opti-Free RepleniSH MPS(control).
386172|NCT01024855|O1|Outcome|RevitaLens|30 subjects, one eye received RevitaLens MPS (investigational).
386173|NCT01024855|E1|Reported Event|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
386174|NCT01024751|B3|Baseline|Total|Total of all reporting groups
386175|NCT01024751|B2|Baseline|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386176|NCT01024751|B1|Baseline|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386177|NCT01024751|P2|Participant Flow|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386178|NCT01024751|P1|Participant Flow|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386179|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386180|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386181|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386182|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386183|NCT01024751|E2|Reported Event|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386184|NCT01024751|E1|Reported Event|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
386185|NCT01024738|B4|Baseline|Total|Total of all reporting groups
386186|NCT01024738|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
386187|NCT01024738|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
386188|NCT01024738|B1|Baseline|Fluoride Toothpaste|negative control toothpaste
386189|NCT01024738|P3|Participant Flow|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
386190|NCT01024738|P2|Participant Flow|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
386191|NCT01024738|P1|Participant Flow|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
386192|NCT01024738|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
397056|NCT00999141|O2|Outcome|A Little Satisfied|
386195|NCT01024738|E3|Reported Event|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
386196|NCT01024738|E2|Reported Event|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
386197|NCT01024738|E1|Reported Event|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
386198|NCT01024608|B3|Baseline|Total|Total of all reporting groups
386199|NCT01024608|B2|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
386200|NCT01024608|B1|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
386201|NCT01024608|P2|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
386202|NCT01024608|P1|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
386203|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
386204|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
386205|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
386206|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
386207|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
386208|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
386209|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
386210|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
386211|NCT01024608|E2|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
386212|NCT01024608|E1|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
386213|NCT01024465|B1|Baseline|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
386214|NCT01024465|P1|Participant Flow|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
386215|NCT01024465|O1|Outcome|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
386216|NCT01024465|E1|Reported Event|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
386217|NCT01024387|B1|Baseline|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386218|NCT01024387|P1|Participant Flow|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386219|NCT01024387|O1|Outcome|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386220|NCT01024387|O1|Outcome|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386221|NCT01024387|O1|Outcome|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386222|NCT01024387|O1|Outcome|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386223|NCT01024387|O1|Outcome|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386224|NCT01024387|E1|Reported Event|AMG 479|Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent.
386225|NCT01024335|B3|Baseline|Total|Total of all reporting groups
386226|NCT01024335|B2|Baseline|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
386709|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386227|NCT01024335|B1|Baseline|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
386228|NCT01024335|P2|Participant Flow|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
386229|NCT01024335|P1|Participant Flow|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
386230|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
386231|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
386232|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
386233|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
386234|NCT01024335|E2|Reported Event|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
386235|NCT01024335|E1|Reported Event|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
386236|NCT01024309|B3|Baseline|Total|Total of all reporting groups
386237|NCT01024309|B2|Baseline|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386238|NCT01024309|B1|Baseline|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386239|NCT01024309|P2|Participant Flow|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386240|NCT01024309|P1|Participant Flow|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386241|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386242|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386243|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386244|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386245|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386246|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386247|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386248|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386249|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386250|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386251|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386252|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386253|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386254|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386255|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386256|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386257|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
386258|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
386259|NCT01024309|E2|Reported Event|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty: Direct Anterior surgical approach for total hip arthroplasty
386260|NCT01024309|E1|Reported Event|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty: Mini-Posterior surgical approach for total hip arthroplasty
386710|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386261|NCT01024296|B1|Baseline|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
386262|NCT01024296|P1|Participant Flow|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
386263|NCT01024296|O1|Outcome|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
386264|NCT01024296|O1|Outcome|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
386265|NCT01024296|E1|Reported Event|Gastric Bypass Surgery Patients|Port Close: Device for applying loop suture to close surgical site
386266|NCT01024244|B6|Baseline|Total|Total of all reporting groups
386267|NCT01024244|B5|Baseline|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386268|NCT01024244|B4|Baseline|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386269|NCT01024244|B3|Baseline|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386270|NCT01024244|B2|Baseline|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386271|NCT01024244|B1|Baseline|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386272|NCT01024244|P5|Participant Flow|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386273|NCT01024244|P4|Participant Flow|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386274|NCT01024244|P3|Participant Flow|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386275|NCT01024244|P2|Participant Flow|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386276|NCT01024244|P1|Participant Flow|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386277|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386278|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386279|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386280|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386281|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386282|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386283|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386284|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386285|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386286|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386287|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386288|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386289|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386290|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386291|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386292|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386293|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386294|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386295|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386296|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386297|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386298|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
397057|NCT00999141|O1|Outcome|Not at All Satisfied|
386299|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386300|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386301|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386302|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386303|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386304|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386305|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386306|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386307|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386308|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386309|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386310|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386311|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386312|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386313|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386314|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386315|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386316|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386317|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386318|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386319|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386320|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386321|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386322|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386323|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386324|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386325|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386326|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386327|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386328|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386329|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386330|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386331|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386332|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386333|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386334|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386512|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386335|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386336|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386337|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386338|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386339|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386340|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386341|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386342|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386343|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386344|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386345|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386346|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386347|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386348|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386349|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386350|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386351|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386352|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386353|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386354|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386355|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386356|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386357|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386358|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386359|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386360|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386361|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386362|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386363|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386364|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386365|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386366|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386367|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386368|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386369|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386370|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386711|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386371|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386372|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386373|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386374|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386375|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386376|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386377|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386378|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386379|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386380|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386381|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386382|NCT01024244|E5|Reported Event|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
386383|NCT01024244|E4|Reported Event|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386384|NCT01024244|E3|Reported Event|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
386385|NCT01024244|E2|Reported Event|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
386386|NCT01024244|E1|Reported Event|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
386387|NCT01024036|B3|Baseline|Total|Total of all reporting groups
386388|NCT01024036|B2|Baseline|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386389|NCT01024036|B1|Baseline|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386390|NCT01024036|P2|Participant Flow|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386391|NCT01024036|P1|Participant Flow|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386513|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386712|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386392|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386393|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386394|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386395|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386396|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386397|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386398|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386426|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386514|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386515|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386399|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386400|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386401|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386402|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386403|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386404|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386405|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386427|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386516|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386517|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386406|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386407|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386408|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386409|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386410|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386411|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386412|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386428|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386518|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386519|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386413|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386414|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
386415|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
386416|NCT01024036|E5|Reported Event|Siltuximab + BSC (Follow-up Period)|No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [siltuximab 11mg/kg as a 1 hour IV infusion every 3 weeks along with ]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier.
386417|NCT01024036|E4|Reported Event|Placebo + BSC (Follow-up Period)|No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [placebo as a 1 hour IV infusion every 3 weeks along with BSC]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier.
386418|NCT01024036|E3|Reported Event|Siltuximab + Best Supportive Care (BSC) (Unblinded)|Participants who had documented treatment failure and wished to continue treatment, their treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab during the unblinded treatment period.
386419|NCT01024036|E2|Reported Event|Siltuximab + Best Supportive Care (BSC) (Blinded)|Participants received siltuximab 11mg/kg as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason completed the end-of-treatment visit and entered the follow-up period.
386420|NCT01024036|E1|Reported Event|Placebo + Best Supportive Care (BSC) (Blinded)|Participants received placebo as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued or completed treatment period up to Week 48, and who consented to enter the follow-up period were continued to be followed up during the course of follow-up period.
386421|NCT01023958|B1|Baseline|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386422|NCT01023958|P1|Participant Flow|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386423|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386424|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386425|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386509|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386429|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386430|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386431|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386432|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386433|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386434|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386435|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386436|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386437|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386438|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386439|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386440|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386441|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386442|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386443|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386444|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386445|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386446|NCT01023958|O1|Outcome|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386447|NCT01023958|E1|Reported Event|Volasertib (BI 6727)|Volasertib (BI 6727) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Single dose, 300 mg as starting dose in first treatment course - possible dose escalation at the beginning of the 2nd course to 350 mg if well tolerated. Repeated administration in patients with clinical benefit until disease progression or intolerability of the study medication
386448|NCT01023841|B3|Baseline|Total|Total of all reporting groups
386449|NCT01023841|B2|Baseline|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386450|NCT01023841|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386451|NCT01023841|P2|Participant Flow|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386452|NCT01023841|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386453|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386454|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386455|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386456|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386457|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386458|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386459|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386460|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386461|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386462|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386463|NCT01023841|E2|Reported Event|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386464|NCT01023841|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
386465|NCT01023815|B5|Baseline|Total|Total of all reporting groups
386466|NCT01023815|B4|Baseline|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386467|NCT01023815|B3|Baseline|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386468|NCT01023815|B2|Baseline|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
386469|NCT01023815|B1|Baseline|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
386510|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386470|NCT01023815|P4|Participant Flow|Randomized: Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386471|NCT01023815|P3|Participant Flow|Randomized: Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386472|NCT01023815|P2|Participant Flow|Randomized: Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
386473|NCT01023815|P1|Participant Flow|Pre-randomized: Not-randomization Patients (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
386474|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386475|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386476|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386477|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386478|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386479|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386480|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386481|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386482|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386483|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386511|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386703|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386484|NCT01023815|O3|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386485|NCT01023815|O2|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386486|NCT01023815|O1|Outcome|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
386487|NCT01023815|E4|Reported Event|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
386488|NCT01023815|E3|Reported Event|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
386489|NCT01023815|E2|Reported Event|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
386490|NCT01023815|E1|Reported Event|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~This population defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP) and described with respect to baseline characteristics, treatment and outcome variables."
386491|NCT01023789|B1|Baseline|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386492|NCT01023789|P1|Participant Flow|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386493|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386494|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386495|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386496|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386497|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386498|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386499|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386500|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386501|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386502|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386503|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386504|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386505|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386506|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386507|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386508|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386520|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386521|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386522|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386523|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386524|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386525|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386526|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386527|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386528|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386529|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386530|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386531|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386532|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386533|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386534|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386535|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386536|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386537|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386538|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386539|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386540|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386541|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386542|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386543|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386544|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386545|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386546|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386547|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386548|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386549|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386550|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386551|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386552|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386553|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386554|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386555|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386556|NCT01023789|O1|Outcome|ABSORB BVS|Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386557|NCT01023789|E1|Reported Event|ABSORB BVS|ABSORB Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
386558|NCT01023776|B1|Baseline|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
386559|NCT01023776|P1|Participant Flow|Live Monovalent H1N1 Vaccine|Subjects received 2 doses of vaccine 0.1 ml in each nostril intranasally 28 days apart
386560|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
386561|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
386562|NCT01023776|E1|Reported Event|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
386563|NCT01023724|B3|Baseline|Total|Total of all reporting groups
386564|NCT01023724|B2|Baseline|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
386704|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386565|NCT01023724|B1|Baseline|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
386566|NCT01023724|P2|Participant Flow|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
386567|NCT01023724|P1|Participant Flow|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
386568|NCT01023724|O2|Outcome|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
386569|NCT01023724|O1|Outcome|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
386570|NCT01023724|E2|Reported Event|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
386571|NCT01023724|E1|Reported Event|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
386572|NCT01023711|B1|Baseline|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
386573|NCT01023711|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
386574|NCT01023711|O1|Outcome|Inactivated H1N1 Vaccine|Inactivated H1N1 vaccine: 0.5 ml IM into Deltoid region of arm
386575|NCT01023711|O1|Outcome|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
386576|NCT01023711|E1|Reported Event|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
386577|NCT01023672|B1|Baseline|Armodifinil|150-250 mg armodafinil by mouth daily
386578|NCT01023672|P1|Participant Flow|Armodifinil|150-250 mg armodafinil by mouth daily
386579|NCT01023672|O1|Outcome|Armodifinil|150-250 mg armodafinil by mouth daily
386580|NCT01023672|E1|Reported Event|Armodifinil|150-250 mg armodafinil by mouth daily
386581|NCT01023659|B4|Baseline|Total|Total of all reporting groups
386582|NCT01023659|B3|Baseline|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
386583|NCT01023659|B2|Baseline|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386584|NCT01023659|B1|Baseline|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386585|NCT01023659|P3|Participant Flow|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
386586|NCT01023659|P2|Participant Flow|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386587|NCT01023659|P1|Participant Flow|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386588|NCT01023659|O1|Outcome|All Eligible Participants|All participants who were eligible to receive medication
386589|NCT01023659|O3|Outcome|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
386590|NCT01023659|O2|Outcome|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386591|NCT01023659|O1|Outcome|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386592|NCT01023659|E3|Reported Event|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
386593|NCT01023659|E2|Reported Event|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386594|NCT01023659|E1|Reported Event|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
386595|NCT01023581|B8|Baseline|Total|Total of all reporting groups
386596|NCT01023581|B7|Baseline|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
386597|NCT01023581|B6|Baseline|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
386598|NCT01023581|B5|Baseline|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
386599|NCT01023581|B4|Baseline|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
386600|NCT01023581|B3|Baseline|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386601|NCT01023581|B2|Baseline|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386602|NCT01023581|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386603|NCT01023581|P7|Participant Flow|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
386604|NCT01023581|P6|Participant Flow|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
386605|NCT01023581|P5|Participant Flow|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
386606|NCT01023581|P4|Participant Flow|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
386607|NCT01023581|P3|Participant Flow|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386608|NCT01023581|P2|Participant Flow|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386609|NCT01023581|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386610|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
386611|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
386612|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
386613|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
386614|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386615|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386616|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386617|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
386618|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
386619|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
386620|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
386621|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386622|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386623|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386624|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
386625|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
386626|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
386627|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
386628|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386629|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386630|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386631|NCT01023581|E7|Reported Event|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
386632|NCT01023581|E6|Reported Event|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
386633|NCT01023581|E5|Reported Event|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
386634|NCT01023581|E4|Reported Event|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
386635|NCT01023581|E3|Reported Event|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386636|NCT01023581|E2|Reported Event|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386637|NCT01023581|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
386638|NCT01023568|B4|Baseline|Total|Total of all reporting groups
386639|NCT01023568|B3|Baseline|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386640|NCT01023568|B2|Baseline|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386641|NCT01023568|B1|Baseline|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386705|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386642|NCT01023568|P3|Participant Flow|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386643|NCT01023568|P2|Participant Flow|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386644|NCT01023568|P1|Participant Flow|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386645|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386646|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386647|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386648|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386649|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386650|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386651|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386652|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386653|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386654|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386655|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386656|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386657|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386658|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386659|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386660|NCT01023568|E3|Reported Event|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
386661|NCT01023568|E2|Reported Event|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
386662|NCT01023568|E1|Reported Event|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
386663|NCT01023516|B3|Baseline|Total|Total of all reporting groups
386664|NCT01023516|B2|Baseline|Placebo|Matched Placebo Tablets
386665|NCT01023516|B1|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386666|NCT01023516|P2|Participant Flow|Placebo|Matched Placebo Tablets
386667|NCT01023516|P1|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386668|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386669|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386670|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386671|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386672|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386673|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386674|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386675|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386676|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386677|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386678|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386679|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386680|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386681|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386682|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386683|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386684|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386685|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386686|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386687|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386688|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386689|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386690|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386691|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386692|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386693|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386694|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386695|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386696|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386697|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386698|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386699|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386700|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386701|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386702|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386713|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386714|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386715|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386716|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386717|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386718|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386719|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386720|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386721|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386722|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386723|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386724|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386725|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386726|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386727|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386728|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386729|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386730|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386731|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386732|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386733|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386734|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386735|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386736|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386737|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386738|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386739|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386740|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386741|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386742|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
386743|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386744|NCT01023516|E2|Reported Event|Placebo|Matched Placebo Tablets
386745|NCT01023516|E1|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
386746|NCT01023308|B3|Baseline|Total|Total of all reporting groups
386747|NCT01023308|B2|Baseline|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386748|NCT01023308|B1|Baseline|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386749|NCT01023308|P2|Participant Flow|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386750|NCT01023308|P1|Participant Flow|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386751|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386752|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386753|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386754|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386755|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386756|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386757|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386758|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386759|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386760|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386800|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386761|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386762|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386763|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386764|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386765|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386766|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386767|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386768|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386769|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386770|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386771|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
386772|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386773|NCT01023308|E2|Reported Event|PBO+BTZ|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..
386774|NCT01023308|E1|Reported Event|PAN+BTZ|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
386775|NCT01023256|B5|Baseline|Total|Total of all reporting groups
386776|NCT01023256|B4|Baseline|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386777|NCT01023256|B3|Baseline|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386778|NCT01023256|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386779|NCT01023256|B1|Baseline|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386780|NCT01023256|P4|Participant Flow|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
386781|NCT01023256|P3|Participant Flow|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386782|NCT01023256|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386783|NCT01023256|P1|Participant Flow|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386784|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386785|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386786|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386787|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386788|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386789|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386790|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386791|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386792|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386793|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386794|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386795|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386796|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386797|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386798|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386799|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386801|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386802|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386803|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386804|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386805|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386806|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386807|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386808|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386809|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386810|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386811|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386812|NCT01023256|O5|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
386813|NCT01023256|O4|Outcome|Pooled Active|All patients receiving MOR103 at any dose
386814|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386815|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386816|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386817|NCT01023256|E5|Reported Event|Pooled Placebo|Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
386818|NCT01023256|E4|Reported Event|Pooled Active|All patients receiving MOR103 at any dose
386819|NCT01023256|E3|Reported Event|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386820|NCT01023256|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386821|NCT01023256|E1|Reported Event|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
386822|NCT01023217|B3|Baseline|Total|Total of all reporting groups
386823|NCT01023217|B2|Baseline|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
386824|NCT01023217|B1|Baseline|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
386825|NCT01023217|P2|Participant Flow|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
386826|NCT01023217|P1|Participant Flow|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
386827|NCT01023217|O2|Outcome|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
386828|NCT01023217|O1|Outcome|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
386829|NCT01023217|E2|Reported Event|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
386830|NCT01023217|E1|Reported Event|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
386831|NCT01023178|B4|Baseline|Total|Total of all reporting groups
386832|NCT01023178|B3|Baseline|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
386833|NCT01023178|B2|Baseline|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
386834|NCT01023178|B1|Baseline|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
386835|NCT01023178|P3|Participant Flow|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
386836|NCT01023178|P2|Participant Flow|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
386837|NCT01023178|P1|Participant Flow|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
386838|NCT01023178|O3|Outcome|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
386839|NCT01023178|O2|Outcome|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
387369|NCT01021007|E2|Reported Event|Iocide Mouthrinse|Experimental mouthrinse
386840|NCT01023178|O1|Outcome|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
386841|NCT01023178|E3|Reported Event|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
386842|NCT01023178|E2|Reported Event|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
386843|NCT01023178|E1|Reported Event|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
386844|NCT01023074|B4|Baseline|Total|Total of all reporting groups
386845|NCT01023074|B3|Baseline|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386846|NCT01023074|B2|Baseline|MS:Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386847|NCT01023074|B1|Baseline|Non-MS Control|Non-MS control group
386848|NCT01023074|P3|Participant Flow|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386849|NCT01023074|P2|Participant Flow|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386850|NCT01023074|P1|Participant Flow|Non-MS Control|Non-MS control group
386851|NCT01023074|O3|Outcome|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386852|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386853|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
386854|NCT01023074|O3|Outcome|MS: Control Activity|MS group not receiving auditory training, doing control activity
386855|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386856|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
386857|NCT01023074|O3|Outcome|Arm 3|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386858|NCT01023074|O2|Outcome|Arm 2|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386859|NCT01023074|O1|Outcome|Arm 1|Non-MS control group
386860|NCT01023074|E3|Reported Event|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386861|NCT01023074|E2|Reported Event|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
386862|NCT01023074|E1|Reported Event|Non-MS Control|Non-MS control group
386863|NCT01023061|B1|Baseline|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
386864|NCT01023061|P1|Participant Flow|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
386865|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given PO~prednisone: Given PO~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
386866|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given PO~prednisone: Given PO~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
386924|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
387370|NCT01021007|E1|Reported Event|Negative Control Rinse|Placebo mouthrinse
386867|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given PO~prednisone: Given PO~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
386868|NCT01023061|E1|Reported Event|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
386869|NCT01023035|B4|Baseline|Total|Total of all reporting groups
386870|NCT01023035|B3|Baseline|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
386871|NCT01023035|B2|Baseline|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
386872|NCT01023035|B1|Baseline|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
386873|NCT01023035|P3|Participant Flow|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
386874|NCT01023035|P2|Participant Flow|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
386875|NCT01023035|P1|Participant Flow|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
386876|NCT01023035|O3|Outcome|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
386877|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
386878|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
386879|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
386880|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
386881|NCT01023035|E3|Reported Event|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
386882|NCT01023035|E2|Reported Event|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
386883|NCT01023035|E1|Reported Event|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
386884|NCT01023022|B1|Baseline|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
386967|NCT01022307|E1|Reported Event|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
386885|NCT01023022|P1|Participant Flow|Medtronic CareLink® Network|"Patients with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
386886|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
386887|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
386888|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
386889|NCT01023022|E1|Reported Event|Patients With Implanted ICD or CRT-D Devices|Patients with implanted ICD or CRT-D devices, who will be monitored via CareLink Network System
386890|NCT01022996|B1|Baseline|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386891|NCT01022996|P1|Participant Flow|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386892|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386893|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386894|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386895|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386925|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386926|NCT01022762|E2|Reported Event|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386968|NCT01022242|B3|Baseline|Total|Total of all reporting groups
386896|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386897|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386898|NCT01022996|E1|Reported Event|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
386899|NCT01022762|B3|Baseline|Total|Total of all reporting groups
386900|NCT01022762|B2|Baseline|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386901|NCT01022762|B1|Baseline|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386902|NCT01022762|P2|Participant Flow|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386903|NCT01022762|P1|Participant Flow|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386904|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386905|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386906|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386907|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386908|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386909|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386910|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386911|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386912|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386913|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386914|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386915|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386916|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386917|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386918|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386919|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386920|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386921|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386922|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
386923|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386927|NCT01022762|E1|Reported Event|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
386928|NCT01022567|B3|Baseline|Total|Total of all reporting groups
386929|NCT01022567|B2|Baseline|Antibiotic Treatment|"Ertapenem 1 g i.v. x 1 three days~Ertapenem: ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o."
386930|NCT01022567|B1|Baseline|Operative Treatment|"Regular open appendicectomy~Appendicectomy: Standard appendicectomy"
386931|NCT01022567|P2|Participant Flow|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.
386932|NCT01022567|P1|Participant Flow|Appendectomy|Open appendectomy
386933|NCT01022567|O2|Outcome|Antibiotic Therapy|
386934|NCT01022567|O1|Outcome|Appendectomy|
386935|NCT01022567|E2|Reported Event|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days
386936|NCT01022567|E1|Reported Event|Appendectomy|Open appendectomy
386937|NCT01022502|B1|Baseline|All Participants (Refined/Crude Ointment)|Two symmetrically comparable plaques on each participant were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Photographs of the lesions were taken and lesion severity was evaluated at baseline and at week 2, 4, 6, and 8.
386938|NCT01022502|P1|Participant Flow|All Participants|In all participants, two bilateral symmetric plaques were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Participants were instructed to avoid cross-contamination between the two treatment sites by washing hands throughly between applications. Treatment was performed until complete clearing, up to a maxmum period of 8 weeks.
386939|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386940|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386941|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386942|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386943|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386944|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386945|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386946|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386947|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386948|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
386949|NCT01022502|E2|Reported Event|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.
386950|NCT01022502|E1|Reported Event|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax.
386951|NCT01022398|B3|Baseline|Total|Total of all reporting groups
386952|NCT01022398|B2|Baseline|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
386953|NCT01022398|B1|Baseline|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
386954|NCT01022398|P2|Participant Flow|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
386955|NCT01022398|P1|Participant Flow|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
386956|NCT01022398|O2|Outcome|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
386957|NCT01022398|O1|Outcome|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
386958|NCT01022398|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
386959|NCT01022307|B3|Baseline|Total|Total of all reporting groups
386960|NCT01022307|B2|Baseline|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
386961|NCT01022307|B1|Baseline|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
386962|NCT01022307|P2|Participant Flow|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI.
386963|NCT01022307|P1|Participant Flow|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
386964|NCT01022307|O2|Outcome|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. Two were excluded because of evidence of malingering.
386965|NCT01022307|O1|Outcome|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
386966|NCT01022307|E2|Reported Event|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
386969|NCT01022242|B2|Baseline|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
386970|NCT01022242|B1|Baseline|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
386971|NCT01022242|P2|Participant Flow|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
386972|NCT01022242|P1|Participant Flow|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo: Placebo is a physiological sodium chloride solution, which is clear and colourless."
386973|NCT01022242|O2|Outcome|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
386974|NCT01022242|O1|Outcome|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
386975|NCT01022242|E2|Reported Event|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
386976|NCT01022242|E1|Reported Event|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
386977|NCT01022203|B3|Baseline|Total|Total of all reporting groups
386978|NCT01022203|B2|Baseline|Arm 2|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
386979|NCT01022203|B1|Baseline|Arm 1|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
386980|NCT01022203|P2|Participant Flow|PTSD Family Education|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
386981|NCT01022203|P1|Participant Flow|Structured Approach Therapy|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
386982|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
386983|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
386984|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
386985|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
386986|NCT01022203|O2|Outcome|PTSD Family Education|Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
386987|NCT01022203|O1|Outcome|Structured Approach Therapy|Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
386988|NCT01022203|E2|Reported Event|PTSD Family Education (PFE)|"Couple-Based Education called PTSD Family Education (PFE) teaches couple about PTSD symptoms, related problems, and treatment.~PTSD Family Education (PFE): PTSD Family Education (PFE) provides education for veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included."
386989|NCT01022203|E1|Reported Event|Structured Approach Therapy (SAT)|"Couple-Based Intervention called Structured Approach Therapy (SAT) provides skills training to couple so they can reduce PTSD.~Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication."
386990|NCT01022190|B1|Baseline|Etoricoxib|
387357|NCT01021020|E1|Reported Event|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6mg after an overnight fast of at least 13.5 hours.
386991|NCT01022190|P1|Participant Flow|Etoricoxib, 90 mg, Orally, Ones a Day|Patients who underwent total hip arthroplasty were administered Etoricoxib, 90 mg, orally, one a day for a 7 day period to prevent heterotopic ossification of the hip joint after the operation.
386992|NCT01022190|O1|Outcome|Etoricoxib, 90 mg, Orally, One a Day for 7 Days Period|Etoricoxib, 90 mg, which was administered orally, for a 7-day period to all participants.
386993|NCT01022190|E1|Reported Event|Etoricoxib|
386994|NCT01022112|B6|Baseline|Total|Total of all reporting groups
386995|NCT01022112|B5|Baseline|Placebo|TA-7284 Placebo, once daily for 12 weeks
386996|NCT01022112|B4|Baseline|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
386997|NCT01022112|B3|Baseline|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
386998|NCT01022112|B2|Baseline|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
386999|NCT01022112|B1|Baseline|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
387000|NCT01022112|P5|Participant Flow|Placebo|TA-7284 Placebo, once daily for 12 weeks
387001|NCT01022112|P4|Participant Flow|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
387002|NCT01022112|P3|Participant Flow|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
387003|NCT01022112|P2|Participant Flow|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
387004|NCT01022112|P1|Participant Flow|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
387005|NCT01022112|O5|Outcome|Placebo|TA-7284 Placebo, once daily for 12 weeks
387006|NCT01022112|O4|Outcome|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
387007|NCT01022112|O3|Outcome|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
387008|NCT01022112|O2|Outcome|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
387009|NCT01022112|O1|Outcome|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
387010|NCT01022112|E5|Reported Event|Placebo|TA-7284 Placebo, once daily for 12 weeks
387011|NCT01022112|E4|Reported Event|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
387012|NCT01022112|E3|Reported Event|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
387013|NCT01022112|E2|Reported Event|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
387014|NCT01022112|E1|Reported Event|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
387015|NCT01022073|B3|Baseline|Total|Total of all reporting groups
387016|NCT01022073|B2|Baseline|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
387017|NCT01022073|B1|Baseline|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
387018|NCT01022073|P2|Participant Flow|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
387019|NCT01022073|P1|Participant Flow|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
387020|NCT01022073|O2|Outcome|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
387021|NCT01022073|O1|Outcome|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
387022|NCT01022073|E2|Reported Event|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
387023|NCT01022073|E1|Reported Event|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
387024|NCT01021878|B3|Baseline|Total|Total of all reporting groups
387025|NCT01021878|B2|Baseline|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
387026|NCT01021878|B1|Baseline|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
387027|NCT01021878|P2|Participant Flow|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~N=27"
387028|NCT01021878|P1|Participant Flow|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~N=33"
387029|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment~Dianeal: glucose based dialysis solution"
387030|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
387031|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment~Dianeal: glucose based dialysis solution"
387032|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
387033|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
387034|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
387035|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
387036|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
387037|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
387038|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
387039|NCT01021878|E2|Reported Event|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
387358|NCT01021007|B3|Baseline|Total|Total of all reporting groups
387359|NCT01021007|B2|Baseline|Iocide Mouthrinse|Experimental mouthrinse
387040|NCT01021878|E1|Reported Event|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
387041|NCT01021852|B9|Baseline|Total|Total of all reporting groups
387042|NCT01021852|B8|Baseline|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387043|NCT01021852|B7|Baseline|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387044|NCT01021852|B6|Baseline|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387045|NCT01021852|B5|Baseline|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387046|NCT01021852|B4|Baseline|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387047|NCT01021852|B3|Baseline|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387048|NCT01021852|B2|Baseline|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387091|NCT01021813|B2|Baseline|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387092|NCT01021813|B1|Baseline|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387360|NCT01021007|B1|Baseline|Negative Control Rinse|Placebo mouthrinse
387361|NCT01021007|P2|Participant Flow|Iocide Mouthrinse|Experimental mouthrinse
387049|NCT01021852|B1|Baseline|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387050|NCT01021852|P8|Participant Flow|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387051|NCT01021852|P7|Participant Flow|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387052|NCT01021852|P6|Participant Flow|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387053|NCT01021852|P5|Participant Flow|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387054|NCT01021852|P4|Participant Flow|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387055|NCT01021852|P3|Participant Flow|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387056|NCT01021852|P2|Participant Flow|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
387168|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
387057|NCT01021852|P1|Participant Flow|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
387058|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387059|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387060|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387061|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387062|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
387063|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387064|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387065|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387066|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387067|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
387068|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387069|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387070|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387071|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387072|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
387073|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387074|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387075|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387076|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387077|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
387078|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387079|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387080|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387081|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387082|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
387083|NCT01021852|E7|Reported Event|Post-Study/Follow-up|Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
387084|NCT01021852|E6|Reported Event|Washout|Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.
387085|NCT01021852|E5|Reported Event|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387086|NCT01021852|E4|Reported Event|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387087|NCT01021852|E3|Reported Event|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387088|NCT01021852|E2|Reported Event|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
387089|NCT01021852|E1|Reported Event|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
387090|NCT01021813|B3|Baseline|Total|Total of all reporting groups
387362|NCT01021007|P1|Participant Flow|Negative Control Rinse|Placebo mouthrinse
387363|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
387093|NCT01021813|P5|Participant Flow|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
387094|NCT01021813|P4|Participant Flow|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
387095|NCT01021813|P3|Participant Flow|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
387096|NCT01021813|P2|Participant Flow|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387097|NCT01021813|P1|Participant Flow|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387098|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase. Following the Treatment Phase, these participants continued on placebo during the 2-month Randomized Discontinuation Phase.
387099|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase. Following the Treatment Phase, these participants were randomized (at baseline) to suvorexant or placebo during the 2-month Randomized Discontinuation Phase.
387100|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387101|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387102|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387103|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387104|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
387105|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
387106|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
387107|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
387108|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
387109|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
387110|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
387111|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
387112|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
387113|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387114|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387115|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387116|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387117|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387169|NCT01021618|E2|Reported Event|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
387118|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387119|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387120|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387121|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387122|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387123|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387124|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387125|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387126|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387127|NCT01021813|E8|Reported Event|Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with dose-matched placebo during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
387128|NCT01021813|E7|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with suvorexant during the 12-Month DB Treatment Period and treatment with dose-matched placebo during the DB the Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
387129|NCT01021813|E6|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up|Following treatment with suvorexant during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
387130|NCT01021813|E5|Reported Event|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
387131|NCT01021813|E4|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
387132|NCT01021813|E3|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
387133|NCT01021813|E2|Reported Event|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
387134|NCT01021813|E1|Reported Event|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
387135|NCT01021761|B4|Baseline|Total|Total of all reporting groups
387136|NCT01021761|B3|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
387137|NCT01021761|B2|Baseline|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387138|NCT01021761|B1|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387139|NCT01021761|P3|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
387140|NCT01021761|P2|Participant Flow|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387141|NCT01021761|P1|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387142|NCT01021761|O3|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
387143|NCT01021761|O2|Outcome|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387144|NCT01021761|O1|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387145|NCT01021761|E3|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
387146|NCT01021761|E2|Reported Event|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387147|NCT01021761|E1|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
387170|NCT01021618|E1|Reported Event|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
387148|NCT01021683|B1|Baseline|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387149|NCT01021683|P1|Participant Flow|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387150|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387151|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387152|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387153|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387154|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387155|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387156|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387157|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387158|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387159|NCT01021683|E1|Reported Event|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
387160|NCT01021618|B3|Baseline|Total|Total of all reporting groups
387161|NCT01021618|B2|Baseline|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
387162|NCT01021618|B1|Baseline|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
387163|NCT01021618|P2|Participant Flow|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
387164|NCT01021618|P1|Participant Flow|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
387165|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
387166|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
387167|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
387171|NCT01021553|B4|Baseline|Total|Total of all reporting groups
387172|NCT01021553|B3|Baseline|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387173|NCT01021553|B2|Baseline|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387174|NCT01021553|B1|Baseline|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387175|NCT01021553|P3|Participant Flow|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387176|NCT01021553|P2|Participant Flow|GSK557296 50 mg|Participants received one 50 milligrams (mg) tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387177|NCT01021553|P1|Participant Flow|Placebo|Participants received 3 placebo tablets matching study drug approximately one hour prior to planned sexual intercourse (SI), once in a 24-hour time period, on-demand for 8 weeks.
387178|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387179|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387180|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387181|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387182|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387183|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387184|NCT01021553|O3|Outcome|GSK557296 150mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387185|NCT01021553|O2|Outcome|GSK557296 50mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks
387186|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387187|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387188|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387189|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387190|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387191|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387192|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387193|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387194|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387195|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387196|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387197|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387198|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387199|NCT01021553|O2|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387200|NCT01021553|O1|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387201|NCT01021553|O2|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387202|NCT01021553|O1|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387203|NCT01021553|O2|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387204|NCT01021553|O1|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387205|NCT01021553|O4|Outcome|Pooled GSK557296|These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
387364|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
387365|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
387206|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387207|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387208|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387209|NCT01021553|O4|Outcome|Pooled GSK557296|These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
387210|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387211|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387212|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387213|NCT01021553|O4|Outcome|Pooled GSK557296|These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
387214|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387215|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387216|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387217|NCT01021553|O4|Outcome|Pooled GSK557296|These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
387218|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387219|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387220|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387221|NCT01021553|O4|Outcome|Pooled GSK557296|These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
387222|NCT01021553|O3|Outcome|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387223|NCT01021553|O2|Outcome|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387224|NCT01021553|O1|Outcome|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387225|NCT01021553|E3|Reported Event|GSK557296 150 mg|Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387226|NCT01021553|E2|Reported Event|GSK557296 50 mg|Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387227|NCT01021553|E1|Reported Event|Placebo|Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
387228|NCT01021423|B3|Baseline|Total|Total of all reporting groups
387229|NCT01021423|B2|Baseline|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387230|NCT01021423|B1|Baseline|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387231|NCT01021423|P2|Participant Flow|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387232|NCT01021423|P1|Participant Flow|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387233|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387234|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387235|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387236|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387237|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387238|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387239|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387240|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387241|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387242|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387243|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387244|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387245|NCT01021423|E2|Reported Event|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387246|NCT01021423|E1|Reported Event|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
387247|NCT01021332|B1|Baseline|Total Group|Participants who received at least one dose of open-label FDC treatment
387248|NCT01021332|P1|Participant Flow|Total Group|Participants who received at least one dose of open-label FDC treatment
387249|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387250|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387251|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387252|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387253|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387254|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387255|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387256|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387257|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
387258|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387259|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387260|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387261|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387262|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387263|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387264|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387265|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387266|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387267|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387268|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387269|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
387270|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387271|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387272|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387273|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387274|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387275|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
387276|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
387277|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
387278|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
387279|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
387280|NCT01021332|E1|Reported Event|Total Group|Participants who received at least one dose of open-label FDC treatment
387281|NCT01021306|B5|Baseline|Total|Total of all reporting groups
387282|NCT01021306|B4|Baseline|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
387283|NCT01021306|B3|Baseline|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
387284|NCT01021306|B2|Baseline|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
387285|NCT01021306|B1|Baseline|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
387286|NCT01021306|P4|Participant Flow|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
387287|NCT01021306|P3|Participant Flow|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
387288|NCT01021306|P2|Participant Flow|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
387289|NCT01021306|P1|Participant Flow|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
387290|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
387291|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
387318|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387292|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
387293|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
387294|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
387295|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
387296|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
387297|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
387298|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
387299|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
387300|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
387355|NCT01021020|E3|Reported Event|Colchicine 0.5 mg/Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg after an overnight fast of at least 13.5 hours.
387301|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
387302|NCT01021306|E4|Reported Event|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
387303|NCT01021306|E3|Reported Event|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
387304|NCT01021306|E2|Reported Event|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
387305|NCT01021306|E1|Reported Event|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
387306|NCT01021293|B3|Baseline|Total|Total of all reporting groups
387307|NCT01021293|B2|Baseline|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387308|NCT01021293|B1|Baseline|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387309|NCT01021293|P2|Participant Flow|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387310|NCT01021293|P1|Participant Flow|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387311|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387312|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387313|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387314|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387315|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387316|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387317|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387356|NCT01021020|E2|Reported Event|Colchicine 0.6 mg (Fed)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
387319|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387320|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387321|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387322|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387323|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387324|NCT01021293|E2|Reported Event|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
387325|NCT01021293|E1|Reported Event|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
387326|NCT01021215|B3|Baseline|Total|Total of all reporting groups
387327|NCT01021215|B2|Baseline|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
387328|NCT01021215|B1|Baseline|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
387329|NCT01021215|P2|Participant Flow|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
387330|NCT01021215|P1|Participant Flow|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
387331|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
387332|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
387333|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
387334|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
387335|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
387336|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
387337|NCT01021215|E2|Reported Event|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
387338|NCT01021215|E1|Reported Event|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
387339|NCT01021111|B1|Baseline|Activity Training With Feedback|Subjects who underwent activity training with feedback
387340|NCT01021111|P1|Participant Flow|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities~Anterior Cruciate Ligament Measurement and Feedback System"
387341|NCT01021111|O1|Outcome|Activity Training With Feedback|Subjects who underwent activity training with feedback
387342|NCT01021111|O1|Outcome|Activity Training With Feedback|Subjects who underwent activity training with feedback
387343|NCT01021111|E1|Reported Event|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities~Anterior Cruciate Ligament Measurement and Feedback System"
387344|NCT01021020|B1|Baseline|Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid|All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
387345|NCT01021020|P1|Participant Flow|Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid|All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
387346|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
387347|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
387348|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
387349|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasting)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast
387350|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
387351|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasting)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
387352|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
387353|NCT01021020|O2|Outcome|Colchicine (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
387354|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
387366|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
387372|NCT01020981|B2|Baseline|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387373|NCT01020981|B1|Baseline|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387374|NCT01020981|P2|Participant Flow|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387375|NCT01020981|P1|Participant Flow|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387376|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
387377|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
387378|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
387379|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
387380|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387381|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387382|NCT01020981|E2|Reported Event|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387383|NCT01020981|E1|Reported Event|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
387384|NCT01020903|B3|Baseline|Total|Total of all reporting groups
387385|NCT01020903|B2|Baseline|Placebo|Placebo: Orally, pre-op
387386|NCT01020903|B1|Baseline|Aprepitant|Aprepitant: 40 mg po pre-op
387387|NCT01020903|P2|Participant Flow|Placebo|Placebo: Orally, pre-op
387388|NCT01020903|P1|Participant Flow|Aprepitant|Aprepitant: 40 mg po pre-op
387389|NCT01020903|O2|Outcome|Placebo|Placebo: Orally, pre-op
387390|NCT01020903|O1|Outcome|Aprepitant|Aprepitant: 40 mg po pre-op
387391|NCT01020903|E2|Reported Event|Placebo|"Placebo: Orally, pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
387392|NCT01020903|E1|Reported Event|Aprepitant|"Aprepitant: 40 mg po pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
387393|NCT01020877|B3|Baseline|Total|Total of all reporting groups
387394|NCT01020877|B2|Baseline|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
387395|NCT01020877|B1|Baseline|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
387396|NCT01020877|P2|Participant Flow|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
387397|NCT01020877|P1|Participant Flow|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
387398|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
387399|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
387400|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
387401|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
387402|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
387403|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
387404|NCT01020877|E2|Reported Event|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
387405|NCT01020877|E1|Reported Event|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
387406|NCT01020838|B1|Baseline|Safety Analysis Set|All study participants who received any amount of florbetaben were included in the safety analysis set.
387407|NCT01020838|P1|Participant Flow|All Study Participants|All patients enrolling into the study
387408|NCT01020838|O3|Outcome|2nd Repeat Drug Administration|The analysis set consisted of data from 3 subjects with brain specimens available.
387409|NCT01020838|O2|Outcome|1st Repeat Drug Administration|The analysis set consisted of data from 20 subjects with brain specimens available.
387410|NCT01020838|O1|Outcome|Initial Drug Administration|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Descriptive statistics of subject level Composite SUVR by SOT for baseline scans and last available scans are reported.
387411|NCT01020838|O2|Outcome|Specificity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Specificity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
387412|NCT01020838|O1|Outcome|Sensitivity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Sensitivity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
387413|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
387414|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
387415|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
387416|NCT01020838|O2|Outcome|Specificity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
387417|NCT01020838|O1|Outcome|Sensitivity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
387418|NCT01020838|E3|Reported Event|2nd Repeat Drug Administration|Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
387419|NCT01020838|E2|Reported Event|1st Repeat Drug Administration|Subjects with TEAEs within 7 days of the 1st repeat drug administration.
387420|NCT01020838|E1|Reported Event|Initial Drug Administration|Subjects with TEAEs within 7 days of the initial administration of florbetaben.
387421|NCT01020812|B1|Baseline|Stereotactic Body Radiotherapy (SBRT)|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
387422|NCT01020812|P1|Participant Flow|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
387423|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
387424|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
387425|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
387426|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
387427|NCT01020812|E1|Reported Event|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
387428|NCT01020799|B4|Baseline|Total|Total of all reporting groups
387429|NCT01020799|B3|Baseline|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387430|NCT01020799|B2|Baseline|Placebo|Placebo matching both AZD7268 and escitalopram
387431|NCT01020799|B1|Baseline|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387432|NCT01020799|P3|Participant Flow|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387433|NCT01020799|P2|Participant Flow|Placebo|Placebo matching both AZD7268 and escitalopram
387434|NCT01020799|P1|Participant Flow|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387435|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387436|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
387437|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387438|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387439|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
387440|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387441|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387442|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
387443|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387444|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387445|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
387446|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387447|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387448|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
387449|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387450|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387451|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
387452|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387453|NCT01020799|E3|Reported Event|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
387454|NCT01020799|E2|Reported Event|Placebo|Placebo matching both AZD7268 and escitalopram
387455|NCT01020799|E1|Reported Event|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
387456|NCT01020786|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387457|NCT01020786|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387458|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387459|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387460|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387461|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387462|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387463|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387490|NCT01020591|O1|Outcome|Pre Test to the Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
387572|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387464|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387465|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387466|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m2) of pemetrexed given intravenously (IV) on Day 1 of every 21 day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 for participant, given IV on Day 1 of every 21 day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m2 of pemetrexed given IV on Day 1 of every 21 day cycle until disease progression or unacceptable toxicity."
387467|NCT01020786|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
387468|NCT01020773|B3|Baseline|Total|Total of all reporting groups
387469|NCT01020773|B2|Baseline|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
387470|NCT01020773|B1|Baseline|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
387471|NCT01020773|P2|Participant Flow|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
387472|NCT01020773|P1|Participant Flow|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
387473|NCT01020773|O2|Outcome|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
387474|NCT01020773|O1|Outcome|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
387475|NCT01020773|E2|Reported Event|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
387476|NCT01020773|E1|Reported Event|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
387477|NCT01020747|B1|Baseline|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
387478|NCT01020747|P1|Participant Flow|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
387479|NCT01020747|O2|Outcome|Untreated Vocal Fold|Subjects received saline injections in combination with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the less diseased vocal fold.
387480|NCT01020747|O1|Outcome|Bevacizumab Treated Vocal Fold|Subjects received injections of bevacizumab in conjunction with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the more diseased vocal fold.
387481|NCT01020747|E1|Reported Event|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
387482|NCT01020591|B3|Baseline|Total|Total of all reporting groups
387483|NCT01020591|B2|Baseline|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
387484|NCT01020591|B1|Baseline|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
387485|NCT01020591|P2|Participant Flow|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
387486|NCT01020591|P1|Participant Flow|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
387487|NCT01020591|O4|Outcome|Post Test to Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
387488|NCT01020591|O3|Outcome|Same Day Post Test to Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
387489|NCT01020591|O2|Outcome|Pre Test to the Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
387491|NCT01020591|E2|Reported Event|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
387708|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387492|NCT01020591|E1|Reported Event|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
387493|NCT01020526|B1|Baseline|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
387494|NCT01020526|P1|Participant Flow|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
387495|NCT01020526|O1|Outcome|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
387496|NCT01020526|E1|Reported Event|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
387497|NCT01020474|B3|Baseline|Total|Total of all reporting groups
387498|NCT01020474|B2|Baseline|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387499|NCT01020474|B1|Baseline|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387500|NCT01020474|P2|Participant Flow|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387501|NCT01020474|P1|Participant Flow|Pregabalin|Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387502|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387503|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387504|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387505|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387506|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387507|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387508|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387509|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387510|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387511|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387512|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387513|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387514|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387515|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387516|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387517|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387563|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387518|NCT01020474|E2|Reported Event|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
387519|NCT01020474|E1|Reported Event|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
387520|NCT01020448|B1|Baseline|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
387521|NCT01020448|P1|Participant Flow|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
387522|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
387523|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
387524|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
387525|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
387526|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
387527|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
387528|NCT01020448|E1|Reported Event|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
387529|NCT01020435|B3|Baseline|Total|Total of all reporting groups
387530|NCT01020435|B2|Baseline|Sham Spinal Manipulation|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
387531|NCT01020435|B1|Baseline|Spinal Manipulation High Velocity|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant’s head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
387532|NCT01020435|P2|Participant Flow|Sham Spinal Manipulation|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
387533|NCT01020435|P1|Participant Flow|Spinal Manipulation High Velocity|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant’s head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
387534|NCT01020435|O1|Outcome|Feasibility Outcomes|Participants recruited, consented, enrolled, and retained, & duration of study from launch date to final outcomes.
387535|NCT01020435|O1|Outcome|Feasibility Outcomes|Participants recruited, consented, enrolled, and retained, & duration of study from launch date to final outcomes.
387536|NCT01020435|O2|Outcome|Sham Spinal Manipulation|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
387564|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387565|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387566|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387567|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387568|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387569|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387570|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387537|NCT01020435|O1|Outcome|Spinal Manipulation High Velocity|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant’s head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
387538|NCT01020435|E2|Reported Event|Sham Spinal Manipulation*|"The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.~Sham Spinal Manipulation: The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same."
387539|NCT01020435|E1|Reported Event|Spinal Manipulation High Velocity*|"This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant’s head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of the head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.~Spinal Manipulation is the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted)."
387540|NCT01020305|B1|Baseline|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
387541|NCT01020305|P1|Participant Flow|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
387542|NCT01020305|O1|Outcome|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
387543|NCT01020305|E1|Reported Event|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
387544|NCT01020123|B8|Baseline|Total|Total of all reporting groups
387545|NCT01020123|B7|Baseline|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387546|NCT01020123|B6|Baseline|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387547|NCT01020123|B5|Baseline|Placebo|Placebo add on to metformin
387548|NCT01020123|B4|Baseline|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387549|NCT01020123|B3|Baseline|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387550|NCT01020123|B2|Baseline|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387551|NCT01020123|B1|Baseline|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387552|NCT01020123|P7|Participant Flow|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387553|NCT01020123|P6|Participant Flow|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387554|NCT01020123|P5|Participant Flow|Placebo|Placebo add on to metformin
387555|NCT01020123|P4|Participant Flow|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387556|NCT01020123|P3|Participant Flow|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387557|NCT01020123|P2|Participant Flow|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387558|NCT01020123|P1|Participant Flow|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387559|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387560|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387561|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387562|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387573|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387574|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387575|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387576|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387577|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387578|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387579|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387580|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387581|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387582|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387583|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387584|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387585|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387586|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387587|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387588|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387589|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387590|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387591|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387592|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387593|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387594|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387595|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387596|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387597|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387598|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387599|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387600|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387601|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387602|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387603|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387604|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387605|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387606|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387607|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387608|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387609|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387610|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387611|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387612|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387613|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387614|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387615|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387616|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387617|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387618|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387619|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387620|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387621|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387622|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387623|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387624|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387625|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387626|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387627|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387628|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387629|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387630|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387631|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387632|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387633|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387634|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387635|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387636|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387637|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387638|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387639|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387640|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387641|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387642|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387643|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387644|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387645|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387646|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387647|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387648|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387649|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387650|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387651|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387652|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387653|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387654|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387655|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387656|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387657|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387658|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387659|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387660|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387661|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387662|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387663|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387664|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387665|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387666|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387667|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387668|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387669|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387670|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387671|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387672|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387673|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387674|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387675|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387676|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387677|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387678|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387679|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387680|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387681|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387682|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387683|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387684|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387685|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387686|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387687|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387688|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387689|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387690|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387691|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387692|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387693|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387694|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387695|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387696|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387697|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387698|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387699|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387700|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387701|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387702|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387703|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387704|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387705|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387706|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387707|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387709|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387710|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387711|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387712|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387713|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387714|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387715|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387716|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387717|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387718|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387719|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387720|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387721|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387722|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387723|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387724|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387725|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387726|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387727|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387728|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387729|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387730|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387731|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387732|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387733|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387734|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387735|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387736|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387737|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387738|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
387739|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387740|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387741|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387742|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387743|NCT01020123|E7|Reported Event|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
387744|NCT01020123|E6|Reported Event|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
387745|NCT01020123|E5|Reported Event|Placebo|Placebo add on to metformin
387746|NCT01020123|E4|Reported Event|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
387747|NCT01020123|E3|Reported Event|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
387748|NCT01020123|E2|Reported Event|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
387749|NCT01020123|E1|Reported Event|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
387750|NCT01020019|B3|Baseline|Total|Total of all reporting groups
387751|NCT01020019|B2|Baseline|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
387752|NCT01020019|B1|Baseline|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
387753|NCT01020019|P2|Participant Flow|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
387754|NCT01020019|P1|Participant Flow|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
387755|NCT01020019|O2|Outcome|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
387756|NCT01020019|O1|Outcome|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
387757|NCT01020019|E2|Reported Event|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
387758|NCT01020019|E1|Reported Event|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
387759|NCT01020006|B4|Baseline|Total|Total of all reporting groups
387760|NCT01020006|B3|Baseline|Gemcitabine/Part B|
387761|NCT01020006|B2|Baseline|(PCI-27483 + Gemcitabine)/Part B|
387762|NCT01020006|B1|Baseline|(PCI-27483 + Gemcitabine)/Part A|
387763|NCT01020006|P3|Participant Flow|Gemcitabine/Part B|Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
387764|NCT01020006|P2|Participant Flow|PCI-27483 + Gemcitabine/Part B|Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
387765|NCT01020006|P1|Participant Flow|PCI-27483 + Gemcitabine/Part A|Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
387766|NCT01020006|O3|Outcome|Gemcitabine/Part B|
387767|NCT01020006|O2|Outcome|(PCI-27483 + Gemcitabine)/Part B|
387768|NCT01020006|O1|Outcome|(PCI-27483 + Gemcitabine)/Part A|
387769|NCT01020006|E3|Reported Event|Gemcitabine/Part B|"Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
387770|NCT01020006|E2|Reported Event|(PCI-27483 + Gemcitabine)/Part B|"Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
387771|NCT01020006|E1|Reported Event|(PCI-27483 + Gemcitabine)/Part A|"Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
387772|NCT01019980|B3|Baseline|Total|Total of all reporting groups
387773|NCT01019980|B2|Baseline|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
387774|NCT01019980|B1|Baseline|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
387775|NCT01019980|P2|Participant Flow|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
387776|NCT01019980|P1|Participant Flow|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
387777|NCT01019980|O2|Outcome|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
387778|NCT01019980|O1|Outcome|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
387779|NCT01019980|E2|Reported Event|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
387780|NCT01019980|E1|Reported Event|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
387781|NCT01019928|B3|Baseline|Total|Total of all reporting groups
387782|NCT01019928|B2|Baseline|Placebo|
387783|NCT01019928|B1|Baseline|AZD1386 95 mg|
387784|NCT01019928|P2|Participant Flow|First Placebo, Then Washout, Then AZD1386|
387785|NCT01019928|P1|Participant Flow|First AZD1386, Then Washout, Then Placebo|
387786|NCT01019928|O2|Outcome|Placebo|
387787|NCT01019928|O1|Outcome|AZD1386 95 mg|
387788|NCT01019928|O2|Outcome|Placebo|
387789|NCT01019928|O1|Outcome|AZD1386 95 mg|
387790|NCT01019928|O2|Outcome|Placebo|
387791|NCT01019928|O1|Outcome|AZD1386 95 mg|
387792|NCT01019928|O2|Outcome|Placebo|
387793|NCT01019928|O1|Outcome|AZD1386 95 mg|
387794|NCT01019928|O2|Outcome|Placebo|
387795|NCT01019928|O1|Outcome|AZD1386 95 mg|
387796|NCT01019928|O2|Outcome|Placebo|
387797|NCT01019928|O1|Outcome|AZD1386 95 mg|
387798|NCT01019928|O2|Outcome|Placebo|
387799|NCT01019928|O1|Outcome|AZD1386 95 mg|
387800|NCT01019928|O2|Outcome|Placebo|
387801|NCT01019928|O1|Outcome|AZD1386 95 mg|
387802|NCT01019928|O2|Outcome|Placebo|
387803|NCT01019928|O1|Outcome|AZD1386 95 mg|
387804|NCT01019928|O2|Outcome|Placebo|
387805|NCT01019928|O1|Outcome|AZD1386 95 mg|
387806|NCT01019928|O2|Outcome|Placebo|
387807|NCT01019928|O1|Outcome|AZD1386 95 mg|
387808|NCT01019928|O2|Outcome|Placebo|
387809|NCT01019928|O1|Outcome|AZD1386 95 mg|
387810|NCT01019928|O2|Outcome|Placebo|
387811|NCT01019928|O1|Outcome|AZD1386 95 mg|
387812|NCT01019928|O2|Outcome|Placebo|
387813|NCT01019928|O1|Outcome|AZD1386 95 mg|
387814|NCT01019928|O2|Outcome|Placebo|
387815|NCT01019928|O1|Outcome|AZD1386 95 mg|
387816|NCT01019928|O2|Outcome|Placebo|
387817|NCT01019928|O1|Outcome|AZD1386 95 mg|
387818|NCT01019928|O2|Outcome|Placebo|
387819|NCT01019928|O1|Outcome|AZD1386 95 mg|
387820|NCT01019928|O2|Outcome|Placebo|
387821|NCT01019928|O1|Outcome|AZD1386 95 mg|
387822|NCT01019928|E2|Reported Event|Placebo|
387823|NCT01019928|E1|Reported Event|AZD1386 95 mg|
387824|NCT01019707|B1|Baseline|Total Sample|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine and placebo. The order of study drug was determined randomly.
387825|NCT01019707|P2|Participant Flow|Placebo, Then Atomoxetine|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under placebo for 15 days and then atomoxetine for 9 days after a 14 day wash out. The order of study drug was determined randomly.
387826|NCT01019707|P1|Participant Flow|Atomoxetine, Then Placebo|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine for 15 days and then placebo for 9 days after a 14 day wash out. The order of study drug was determined randomly.
387827|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
387828|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
387829|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
387830|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
387880|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387831|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
387832|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
387833|NCT01019707|E2|Reported Event|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
387834|NCT01019707|E1|Reported Event|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
387835|NCT01019694|B4|Baseline|Total|Total of all reporting groups
387836|NCT01019694|B3|Baseline|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387837|NCT01019694|B2|Baseline|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387838|NCT01019694|B1|Baseline|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387839|NCT01019694|P3|Participant Flow|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387840|NCT01019694|P2|Participant Flow|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387841|NCT01019694|P1|Participant Flow|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387842|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387843|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387844|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387845|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387846|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387847|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387848|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387849|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387850|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387851|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387852|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387853|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387854|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387855|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387856|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387857|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387858|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387859|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387860|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387861|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387862|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387863|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387864|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387865|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387866|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387867|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387868|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387869|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387870|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387871|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387872|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387873|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387874|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387875|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387876|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387877|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387878|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387879|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
397058|NCT00999141|O5|Outcome|Strongly Prefer SoC Side|
387881|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387882|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387883|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387884|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387885|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387886|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387887|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387888|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387889|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387890|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387891|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387892|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387893|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387894|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387895|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387896|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387897|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387898|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387899|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387900|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387901|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387902|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387903|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387904|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387905|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387906|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387907|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387908|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387909|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387910|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387911|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387912|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387913|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387914|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387915|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387916|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387917|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387918|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387919|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387920|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387921|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387922|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387923|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387924|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387925|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387926|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387927|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387928|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387929|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387930|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387931|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387932|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387933|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387934|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387935|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387936|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387937|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387938|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387939|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387940|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387941|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387942|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387943|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387944|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387945|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387946|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387947|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387948|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387949|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387950|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387951|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387952|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387953|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387954|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387955|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387956|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387957|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387958|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387959|NCT01019694|E3|Reported Event|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
387960|NCT01019694|E2|Reported Event|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
387961|NCT01019694|E1|Reported Event|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
387962|NCT01019486|B4|Baseline|Total|Total of all reporting groups
387963|NCT01019486|B3|Baseline|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
387964|NCT01019486|B2|Baseline|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
387965|NCT01019486|B1|Baseline|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
387966|NCT01019486|P3|Participant Flow|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
387967|NCT01019486|P2|Participant Flow|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
387968|NCT01019486|P1|Participant Flow|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
387969|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
387970|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
387971|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
387972|NCT01019486|O1|Outcome|Abnormal MPI Study|These subjects demonstrated abnormal radionuclide myocardial perfusion imaging studies with perfusion defects in response to regadenoson stress. The perfusion defect qualified the subject to participated in invasive CFR measurements. Coronary arteries within the region of the perfusion defect were cannulated for CFR measurements. Flow measurements were performed in the 2 normal vessels and the abnormal vessel both at rest and following regadenoson administration to calculated CFR values..
387973|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
387974|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
387975|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
387976|NCT01019486|E3|Reported Event|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
387977|NCT01019486|E2|Reported Event|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
387978|NCT01019486|E1|Reported Event|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
387979|NCT01019369|B3|Baseline|Total|Total of all reporting groups
387980|NCT01019369|B2|Baseline|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
387981|NCT01019369|B1|Baseline|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
387982|NCT01019369|P2|Participant Flow|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
387983|NCT01019369|P1|Participant Flow|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
387984|NCT01019369|O2|Outcome|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
388029|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
387985|NCT01019369|O1|Outcome|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
387986|NCT01019369|E2|Reported Event|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
387987|NCT01019369|E1|Reported Event|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
387988|NCT01019317|B1|Baseline|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
387989|NCT01019317|P1|Participant Flow|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
387990|NCT01019317|O1|Outcome|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
387991|NCT01019317|E1|Reported Event|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
387992|NCT01019135|B4|Baseline|Total|Total of all reporting groups
387993|NCT01019135|B3|Baseline|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
387994|NCT01019135|B2|Baseline|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
387995|NCT01019135|B1|Baseline|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
387996|NCT01019135|P3|Participant Flow|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
387997|NCT01019135|P2|Participant Flow|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
387998|NCT01019135|P1|Participant Flow|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
387999|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388000|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388001|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388002|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388003|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388004|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388005|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388006|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388007|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388008|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388009|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388010|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388011|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388012|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388013|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388014|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388015|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388016|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388017|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388018|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388019|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388020|NCT01019135|E3|Reported Event|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388021|NCT01019135|E2|Reported Event|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388022|NCT01019135|E1|Reported Event|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
388023|NCT01018992|B3|Baseline|Total|Total of all reporting groups
388024|NCT01018992|B2|Baseline|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
388025|NCT01018992|B1|Baseline|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
388026|NCT01018992|P2|Participant Flow|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
388027|NCT01018992|P1|Participant Flow|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
388028|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
388722|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388030|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
388031|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
388032|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
388033|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
388034|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
388035|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
388036|NCT01018992|E2|Reported Event|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
388037|NCT01018992|E1|Reported Event|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
388038|NCT01018979|B3|Baseline|Total|Total of all reporting groups
388039|NCT01018979|B2|Baseline|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388040|NCT01018979|B1|Baseline|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388041|NCT01018979|P2|Participant Flow|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388042|NCT01018979|P1|Participant Flow|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388043|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
388044|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
388045|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
388046|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388047|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388048|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388049|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388050|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388051|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388052|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388053|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388054|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388055|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388056|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388057|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388058|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388059|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388060|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388061|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388062|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
388063|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
388064|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
388065|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388066|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388067|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388068|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388069|NCT01018979|E2|Reported Event|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388070|NCT01018979|E1|Reported Event|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
388071|NCT01018953|B1|Baseline|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
388072|NCT01018953|P1|Participant Flow|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
388073|NCT01018953|O1|Outcome|BIM 23A760|
388074|NCT01018953|O1|Outcome|BIM 23A760|
388075|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
388076|NCT01018953|O1|Outcome|BIM 23A760|
388077|NCT01018953|O1|Outcome|BIM 23A760|
388078|NCT01018953|O1|Outcome|BIM 23A760|
388079|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
388080|NCT01018953|E1|Reported Event|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
388081|NCT01018862|B4|Baseline|Total|Total of all reporting groups
388082|NCT01018862|B3|Baseline|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388083|NCT01018862|B2|Baseline|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388084|NCT01018862|B1|Baseline|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388085|NCT01018862|P3|Participant Flow|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388086|NCT01018862|P2|Participant Flow|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388087|NCT01018862|P1|Participant Flow|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388088|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388089|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388090|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388091|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388092|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388093|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388094|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388095|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388096|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388097|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388098|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388099|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388100|NCT01018862|E3|Reported Event|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388101|NCT01018862|E2|Reported Event|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388102|NCT01018862|E1|Reported Event|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
388103|NCT01018810|B6|Baseline|Total|Total of all reporting groups
388104|NCT01018810|B5|Baseline|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388105|NCT01018810|B4|Baseline|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388106|NCT01018810|B3|Baseline|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388107|NCT01018810|B2|Baseline|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388108|NCT01018810|B1|Baseline|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388109|NCT01018810|P5|Participant Flow|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388110|NCT01018810|P4|Participant Flow|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388111|NCT01018810|P3|Participant Flow|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388112|NCT01018810|P2|Participant Flow|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388113|NCT01018810|P1|Participant Flow|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388114|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388115|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388116|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388117|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388118|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388119|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388120|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388121|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388122|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388123|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388124|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388125|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388126|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388127|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388128|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388129|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388130|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388131|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388132|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388133|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388134|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388135|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388136|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388137|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388138|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388139|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388140|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388141|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388142|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388143|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388144|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388145|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388146|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388147|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388148|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388149|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388150|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388151|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388152|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388153|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388154|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388155|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388156|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388157|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388158|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388159|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388160|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388161|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
388162|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
388163|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
388164|NCT01018810|E5|Reported Event|90 mg LY2525623|
388165|NCT01018810|E4|Reported Event|30 mg LY2525623|
388166|NCT01018810|E3|Reported Event|3 mg LY2525623|
388167|NCT01018810|E2|Reported Event|Subcutaneous Placebo|
388168|NCT01018810|E1|Reported Event|180 mg LY2525623|
388169|NCT01018732|B4|Baseline|Total|Total of all reporting groups
388170|NCT01018732|B3|Baseline|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
388171|NCT01018732|B2|Baseline|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
388172|NCT01018732|B1|Baseline|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
388173|NCT01018732|P3|Participant Flow|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
388174|NCT01018732|P2|Participant Flow|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
388175|NCT01018732|P1|Participant Flow|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
388176|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388177|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388178|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388179|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388180|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388181|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388182|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388183|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388184|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388185|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388186|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388187|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388188|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388189|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388190|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388191|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388192|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388193|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388194|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388195|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388196|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388197|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388198|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388199|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388200|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
388201|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388202|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
388203|NCT01018732|E3|Reported Event|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
388204|NCT01018732|E2|Reported Event|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
388205|NCT01018732|E1|Reported Event|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
388206|NCT01018680|B3|Baseline|Total|Total of all reporting groups
388207|NCT01018680|B2|Baseline|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388208|NCT01018680|B1|Baseline|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388209|NCT01018680|P2|Participant Flow|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388210|NCT01018680|P1|Participant Flow|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388211|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388212|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388213|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388214|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388215|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388216|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388217|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388218|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388219|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388220|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388221|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388222|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388223|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388224|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388225|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388226|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388227|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388228|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388229|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388230|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388231|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388232|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388233|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388234|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388235|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388236|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388237|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388238|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388239|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388240|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388241|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388242|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388243|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388244|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388245|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388246|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388247|NCT01018680|E2|Reported Event|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
388248|NCT01018680|E1|Reported Event|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
388249|NCT01020487|B4|Baseline|Total|Total of all reporting groups
388250|NCT01020487|B3|Baseline|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388251|NCT01020487|B2|Baseline|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388252|NCT01020487|B1|Baseline|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
388253|NCT01020487|P3|Participant Flow|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388254|NCT01020487|P2|Participant Flow|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388255|NCT01020487|P1|Participant Flow|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
388256|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388257|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388258|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388259|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388260|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388261|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388262|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388263|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388264|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388265|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388266|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
388267|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
388268|NCT01020487|O1|Outcome|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
388269|NCT01020487|O1|Outcome|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
388270|NCT01020487|E5|Reported Event|Part 2: Paricalcitol/Paricalcitol|Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24).
388271|NCT01020487|E4|Reported Event|Part 2: Placebo/Paricalcitol|Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels.
388272|NCT01020487|E3|Reported Event|Part 2: Paricalcitol|Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels.
388273|NCT01020487|E2|Reported Event|Part 2: Placebo|Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase.
388274|NCT01020487|E1|Reported Event|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
388275|NCT01018511|B5|Baseline|Total|Total of all reporting groups
388276|NCT01018511|B4|Baseline|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388277|NCT01018511|B3|Baseline|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388278|NCT01018511|B2|Baseline|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388279|NCT01018511|B1|Baseline|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388280|NCT01018511|P4|Participant Flow|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388281|NCT01018511|P3|Participant Flow|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388282|NCT01018511|P2|Participant Flow|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388283|NCT01018511|P1|Participant Flow|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388284|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388285|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388286|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388287|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388288|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388289|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388290|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388291|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388292|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388293|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388294|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388295|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388296|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388297|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388298|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388299|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388300|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388301|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388302|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388723|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
397059|NCT00999141|O4|Outcome|Somewhat Prefer SoC Side|
388303|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388304|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388305|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388306|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388307|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388308|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388309|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388310|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388311|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388312|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388313|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388314|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388315|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388316|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388317|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388318|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388319|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388320|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388321|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388322|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388323|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388324|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388325|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388326|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
397060|NCT00999141|O3|Outcome|No Preference|
388327|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388328|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388329|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388330|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388331|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388332|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388333|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388334|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388335|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388336|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388337|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388338|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388339|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388340|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388341|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388342|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388343|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388344|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388345|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388346|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388347|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388348|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388349|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388724|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388725|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388350|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388351|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388352|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388353|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388354|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388355|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388356|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388357|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388358|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388359|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388360|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388361|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388362|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388363|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388364|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388365|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388366|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388367|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388368|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388369|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388370|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388371|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388372|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388726|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388373|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388374|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388375|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388376|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388377|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388378|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388379|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388380|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388381|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388382|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388383|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388384|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388385|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388386|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388387|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388388|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388389|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388390|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388391|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388392|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388393|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388394|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388395|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388419|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388396|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388397|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388398|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388399|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388400|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388401|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388402|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388403|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388404|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388405|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388406|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388407|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388408|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388409|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388410|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388411|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388412|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388413|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388414|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388415|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388416|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388417|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388418|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388612|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388420|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388421|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388422|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388423|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388424|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388425|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388426|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388427|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388428|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388429|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388430|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388431|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388432|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388433|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388434|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388435|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388436|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388437|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388438|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388439|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388440|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388441|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388442|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388613|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388443|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388444|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388445|NCT01018511|E4|Reported Event|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388446|NCT01018511|E3|Reported Event|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388447|NCT01018511|E2|Reported Event|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388448|NCT01018511|E1|Reported Event|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
388449|NCT01018420|B3|Baseline|Total|Total of all reporting groups
388450|NCT01018420|B2|Baseline|Moxifloxacin|400 mg capsule at the 6 hour point
388451|NCT01018420|B1|Baseline|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
388452|NCT01018420|P2|Participant Flow|Moxifloxacin|400 mg capsule at the 6 hour point
388453|NCT01018420|P1|Participant Flow|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
388454|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after moxifloxacin dose
388455|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after moxifloxacin dose
388456|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after moxifloxacin dose
388457|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after moxifloxacin dose
388458|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after moxifloxacin dose
388459|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after moxifloxacin dose
388460|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after moxifloxacin dose
388461|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after moxifloxacin dose
388462|NCT01018420|O1|Outcome|Baseline|measured 0.5 hour prior to moxifloxacin dose
388463|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after initial colchicine dose
388464|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after initial colchicine dose
388465|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after initial colchicine dose
388466|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after initial colchicine dose
388467|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after initial colchicine dose
388468|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after initial colchicine dose
388469|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after initial colchicine dose
388470|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after initial colchicine dose
388471|NCT01018420|O1|Outcome|Baseline|measured 0.5 hr prior to initial colchicine dose
388472|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
388473|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
388474|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
388475|NCT01018420|E2|Reported Event|Moxifloxacin|400 mg capsule at the 6 hour point
388476|NCT01018420|E1|Reported Event|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
388477|NCT01018394|B3|Baseline|Total|Total of all reporting groups
388478|NCT01018394|B2|Baseline|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
388479|NCT01018394|B1|Baseline|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
388480|NCT01018394|P2|Participant Flow|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
388481|NCT01018394|P1|Participant Flow|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
388482|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
388483|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
388484|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
388485|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
388486|NCT01018394|E2|Reported Event|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
388487|NCT01018394|E1|Reported Event|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
388488|NCT01018264|B3|Baseline|Total|Total of all reporting groups
388489|NCT01018264|B2|Baseline|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388490|NCT01018264|B1|Baseline|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388491|NCT01018264|P2|Participant Flow|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388492|NCT01018264|P1|Participant Flow|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388493|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388494|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388495|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388496|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388497|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388498|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388499|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388500|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388501|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388502|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388503|NCT01018264|E2|Reported Event|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
388504|NCT01018264|E1|Reported Event|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
388505|NCT01018186|B4|Baseline|Total|Total of all reporting groups
388506|NCT01018186|B3|Baseline|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388507|NCT01018186|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388508|NCT01018186|B1|Baseline|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388509|NCT01018186|P4|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388510|NCT01018186|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388511|NCT01018186|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388512|NCT01018186|P1|Participant Flow|Current Asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) with or without an additional controller medication (i.e., long-acting beta-agonist, leukotriene modifier, etc.) for 2 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
388513|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388514|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388515|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388516|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388614|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388517|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388518|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388519|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388520|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388521|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388522|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388523|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388524|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388525|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388526|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388527|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388528|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388529|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388530|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388531|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388532|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388533|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388534|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388535|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388536|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388537|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388538|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388539|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388727|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388540|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388541|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388542|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388543|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388544|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388545|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388546|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388547|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388548|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388549|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388550|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388551|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388552|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388553|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388554|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388555|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388556|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388557|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388558|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388559|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388560|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388561|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388562|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388728|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
397061|NCT00999141|O2|Outcome|Somewhat Prefer FS VH S/D 4 S-apr Side|
388563|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388564|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albutero/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388565|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participnts were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388566|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388567|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388568|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388569|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388570|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388571|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388572|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388573|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388574|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388575|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388576|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388577|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388578|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388579|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388580|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388581|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388582|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388583|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388584|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388585|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388729|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388586|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388587|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388588|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388589|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388590|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388591|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388592|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388593|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388594|NCT01018186|E3|Reported Event|FP 500 µg BD|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388595|NCT01018186|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388596|NCT01018186|E1|Reported Event|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
388597|NCT01018134|B7|Baseline|Total|Total of all reporting groups
388598|NCT01018134|B6|Baseline|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388599|NCT01018134|B5|Baseline|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388600|NCT01018134|B4|Baseline|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388601|NCT01018134|B3|Baseline|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388602|NCT01018134|B2|Baseline|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388603|NCT01018134|B1|Baseline|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388604|NCT01018134|P6|Participant Flow|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388605|NCT01018134|P5|Participant Flow|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388606|NCT01018134|P4|Participant Flow|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388607|NCT01018134|P3|Participant Flow|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388608|NCT01018134|P2|Participant Flow|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388609|NCT01018134|P1|Participant Flow|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388610|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388611|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388730|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388615|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388616|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388617|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388618|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388619|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388620|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388621|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388622|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388623|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388624|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388625|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388626|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388627|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388628|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388629|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388630|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388631|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388632|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388633|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388634|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388635|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388636|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388637|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388638|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388639|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388640|NCT01018134|E6|Reported Event|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
388641|NCT01018134|E5|Reported Event|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
388642|NCT01018134|E4|Reported Event|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
388643|NCT01018134|E3|Reported Event|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
388644|NCT01018134|E2|Reported Event|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
388645|NCT01018134|E1|Reported Event|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
388646|NCT01018095|B3|Baseline|Total|Total of all reporting groups
388647|NCT01018095|B2|Baseline|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388648|NCT01018095|B1|Baseline|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388649|NCT01018095|P2|Participant Flow|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388650|NCT01018095|P1|Participant Flow|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388651|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388652|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388653|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388654|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388655|NCT01018095|E2|Reported Event|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388656|NCT01018095|E1|Reported Event|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
388657|NCT01018056|B4|Baseline|Total|Total of all reporting groups
388658|NCT01018056|B3|Baseline|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388659|NCT01018056|B2|Baseline|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388660|NCT01018056|B1|Baseline|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388661|NCT01018056|P3|Participant Flow|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388662|NCT01018056|P2|Participant Flow|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388663|NCT01018056|P1|Participant Flow|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388664|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388714|NCT01018030|P2|Participant Flow|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388715|NCT01018030|P1|Participant Flow|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
388665|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388666|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388667|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388668|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388669|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388670|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388671|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388672|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388673|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388716|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388717|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388674|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388675|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388676|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388677|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388678|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient's weight. No changes in dosage will be made during the final week of treatment."
388679|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4."
388680|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388681|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388682|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3."
388683|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388684|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388685|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4."
388686|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388687|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388688|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388689|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388690|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388691|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388718|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388692|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388693|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388694|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388695|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388696|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388697|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388698|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388699|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388700|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388719|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388720|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388701|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388702|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388703|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388704|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388705|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388706|NCT01018056|E3|Reported Event|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
388707|NCT01018056|E2|Reported Event|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
388708|NCT01018056|E1|Reported Event|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
388709|NCT01018030|B4|Baseline|Total|Total of all reporting groups
388710|NCT01018030|B3|Baseline|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388711|NCT01018030|B2|Baseline|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388712|NCT01018030|B1|Baseline|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
388713|NCT01018030|P3|Participant Flow|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388721|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388731|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388732|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388733|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388734|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388735|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388736|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388737|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388738|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388739|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388740|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388741|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388742|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388743|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388744|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388745|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388746|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388747|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388748|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388749|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388750|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388751|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388752|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388753|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388754|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
388755|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388756|NCT01018030|O2|Outcome|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388757|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
388758|NCT01018030|E3|Reported Event|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
388759|NCT01018030|E2|Reported Event|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
388760|NCT01018030|E1|Reported Event|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
388761|NCT01017952|B5|Baseline|Total|Total of all reporting groups
388762|NCT01017952|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388763|NCT01017952|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388764|NCT01017952|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388765|NCT01017952|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388766|NCT01017952|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388767|NCT01017952|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388768|NCT01017952|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388769|NCT01017952|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388770|NCT01017952|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
391879|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
388771|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388772|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388773|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388774|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388775|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388776|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388777|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388778|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388779|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388780|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388781|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388782|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388783|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388784|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388785|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388786|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388787|NCT01017952|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388788|NCT01017952|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388789|NCT01017952|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388790|NCT01017952|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
388791|NCT01017874|B3|Baseline|Total|Total of all reporting groups
388792|NCT01017874|B2|Baseline|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388793|NCT01017874|B1|Baseline|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388794|NCT01017874|P2|Participant Flow|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388795|NCT01017874|P1|Participant Flow|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388796|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388797|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388798|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388799|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388800|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388801|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388802|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388803|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388804|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388805|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388806|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388807|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388808|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388809|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388810|NCT01017874|E2|Reported Event|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
388811|NCT01017874|E1|Reported Event|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
388812|NCT01017731|B1|Baseline|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388813|NCT01017731|P1|Participant Flow|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
397062|NCT00999141|O1|Outcome|Strongly Prefer FS VH S/D 4 S-apr Side|
388814|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388815|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously over 1 hour, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: 25 to 50 milligrams (mg) administered intravenously 1 day before each administration of ramucirumab for Cycles 1 to 4. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388816|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388817|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388818|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388819|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388820|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388821|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388831|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
397063|NCT00999141|O1|Outcome|Facelift Participants|
388822|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388823|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388824|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388825|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388826|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388827|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388828|NCT01017731|E1|Reported Event|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
388829|NCT01017653|B1|Baseline|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388830|NCT01017653|P1|Participant Flow|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388924|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
388832|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388833|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388834|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388835|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388836|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388837|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388838|NCT01017653|E1|Reported Event|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
388839|NCT01017601|B3|Baseline|Total|Total of all reporting groups
388840|NCT01017601|B2|Baseline|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388841|NCT01017601|B1|Baseline|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388842|NCT01017601|P2|Participant Flow|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388843|NCT01017601|P1|Participant Flow|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388844|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388845|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388846|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388847|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388848|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388849|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388850|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388851|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388852|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388853|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388854|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388855|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388856|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388857|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388858|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388859|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388860|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388861|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388862|NCT01017601|E2|Reported Event|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
388863|NCT01017601|E1|Reported Event|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
388864|NCT01017575|B6|Baseline|Total|Total of all reporting groups
388925|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
397064|NCT00999141|O8|Outcome|SoC Side - Day 14|
388865|NCT01017575|B5|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388866|NCT01017575|B4|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388867|NCT01017575|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388868|NCT01017575|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388869|NCT01017575|B1|Baseline|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388870|NCT01017575|P5|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388871|NCT01017575|P4|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388872|NCT01017575|P3|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388873|NCT01017575|P2|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388874|NCT01017575|P1|Participant Flow|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388875|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388876|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388877|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388878|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388879|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388880|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388881|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388882|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
389009|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388883|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388884|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388885|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388886|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388887|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388888|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388889|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388890|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388891|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388892|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388893|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388894|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388895|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388896|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388897|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388898|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388899|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388900|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
389677|NCT01015677|P3|Participant Flow|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
388901|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388902|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388903|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
388904|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
388905|NCT01017575|E5|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388906|NCT01017575|E4|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
388907|NCT01017575|E3|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
388908|NCT01017575|E2|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
388909|NCT01017575|E1|Reported Event|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
388910|NCT01017549|B1|Baseline|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
388911|NCT01017549|P1|Participant Flow|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
388912|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
388913|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
388914|NCT01017549|E1|Reported Event|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
388915|NCT01017536|B3|Baseline|Total|Total of all reporting groups
388916|NCT01017536|B2|Baseline|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
388917|NCT01017536|B1|Baseline|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
388918|NCT01017536|P2|Participant Flow|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
388919|NCT01017536|P1|Participant Flow|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
388920|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
388921|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
388922|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
388923|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
388962|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388926|NCT01017536|E2|Reported Event|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
388927|NCT01017536|E1|Reported Event|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
388928|NCT01017497|B1|Baseline|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388929|NCT01017497|P1|Participant Flow|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388930|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388931|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388932|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388933|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388934|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388935|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388936|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
388937|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
388938|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
388939|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
388940|NCT01017497|E1|Reported Event|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
388941|NCT01017263|B1|Baseline|Open Label Vyvanse|All subjects receive Vyvanse.
388942|NCT01017263|P1|Participant Flow|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
388943|NCT01017263|O1|Outcome|Vyvanse Open Label|Eligible subjects were dispensed open label LDX (VyvanseTM). All subjects started at 20 mg once a day dose and were titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level was allowed.
388944|NCT01017263|E1|Reported Event|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
388945|NCT01017250|B1|Baseline|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388946|NCT01017250|P1|Participant Flow|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388947|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388948|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388949|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388950|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388951|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388952|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388953|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388954|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
388955|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388956|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388957|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388958|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388959|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388960|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388961|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388963|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388964|NCT01017250|E1|Reported Event|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
388965|NCT01017237|B3|Baseline|Total|Total of all reporting groups
388966|NCT01017237|B2|Baseline|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388967|NCT01017237|B1|Baseline|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
388968|NCT01017237|P2|Participant Flow|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388969|NCT01017237|P1|Participant Flow|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
388970|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388971|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388972|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388973|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388974|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388975|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
388976|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388977|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
388978|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388979|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
389682|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
388980|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388981|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388982|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388983|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388984|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388985|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388986|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388987|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388988|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388989|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
388990|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388991|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
388992|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388993|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
388994|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388995|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
391013|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
388996|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388997|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
388998|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
388999|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389000|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389001|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389002|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389003|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389004|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389005|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389006|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389007|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389008|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
391880|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
389010|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389011|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
389012|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389013|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389014|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389015|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389016|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389017|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389018|NCT01017237|E2|Reported Event|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
389019|NCT01017237|E1|Reported Event|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
389020|NCT01017146|B3|Baseline|Total|Total of all reporting groups
389021|NCT01017146|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389022|NCT01017146|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389023|NCT01017146|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389024|NCT01017146|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389025|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389026|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389027|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389028|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389029|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389030|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389031|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389032|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389033|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389034|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389035|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389036|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389037|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389038|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389039|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389040|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389041|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389042|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389176|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389043|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389044|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389045|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389046|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389047|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389048|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389049|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389050|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389051|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389052|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389053|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389054|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389055|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389056|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389057|NCT01017146|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389058|NCT01017146|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389059|NCT01017120|B3|Baseline|Total|Total of all reporting groups
389060|NCT01017120|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
391014|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
389061|NCT01017120|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389062|NCT01017120|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389063|NCT01017120|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389064|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389065|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389066|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389067|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389068|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389069|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389070|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389071|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389072|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389073|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389074|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389075|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389076|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389077|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389296|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389078|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389079|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389080|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389081|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389082|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389083|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389084|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389085|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389086|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389087|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389088|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389089|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389090|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389091|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389092|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389093|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389094|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389177|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389095|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389096|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389097|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389098|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389099|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389100|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389101|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389102|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389103|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389104|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389105|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389106|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389107|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389108|NCT01017120|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389109|NCT01017120|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
389110|NCT01017042|B1|Baseline|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
389111|NCT01017042|P1|Participant Flow|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
389178|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
397065|NCT00999141|O7|Outcome|FS VH S/D 4 S-apr Side - Day 14|
389112|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
389113|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
389114|NCT01017042|O5|Outcome|Corrected QTc Interval (4 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (4 hour)
389115|NCT01017042|O4|Outcome|Corrected QTc Interval (2 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (2 hour)
389116|NCT01017042|O3|Outcome|Corrected QTc Interval (1 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (1 hour)
389117|NCT01017042|O2|Outcome|Corrected QTc Interval (0.5 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (0.5hour)
389118|NCT01017042|O1|Outcome|Corrected QTc Interval (Baseline)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (Baseline)
389119|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
389120|NCT01017042|E1|Reported Event|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
389121|NCT01017029|B3|Baseline|Total|Total of all reporting groups
389122|NCT01017029|B2|Baseline|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389123|NCT01017029|B1|Baseline|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389124|NCT01017029|P2|Participant Flow|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389125|NCT01017029|P1|Participant Flow|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389126|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389127|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389128|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389129|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389130|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389131|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389132|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389133|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389134|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389135|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389136|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389137|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389138|NCT01017029|E2|Reported Event|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
389139|NCT01017029|E1|Reported Event|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
389140|NCT01017003|B1|Baseline|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
397066|NCT00999141|O6|Outcome|SoC Side - Day 7|
389141|NCT01017003|P1|Participant Flow|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
389142|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
389143|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
389144|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
389145|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
389146|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
389147|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
389148|NCT01017003|E2|Reported Event|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
389149|NCT01017003|E1|Reported Event|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
389150|NCT01016977|B3|Baseline|Total|Total of all reporting groups
389151|NCT01016977|B2|Baseline|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389152|NCT01016977|B1|Baseline|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
389153|NCT01016977|P2|Participant Flow|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389154|NCT01016977|P1|Participant Flow|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
389155|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389156|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389157|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389158|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389159|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389160|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389161|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389162|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389163|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389164|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389165|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389166|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389167|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389168|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389169|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389170|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389171|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389172|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389173|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389174|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389175|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389179|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389180|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389181|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389182|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
389183|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389184|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
389185|NCT01016977|E2|Reported Event|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
389186|NCT01016977|E1|Reported Event|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
389187|NCT01016964|B3|Baseline|Total|Total of all reporting groups
389188|NCT01016964|B2|Baseline|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
389189|NCT01016964|B1|Baseline|Sham Device|Sham device
389190|NCT01016964|P2|Participant Flow|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
389191|NCT01016964|P1|Participant Flow|Sham Device|Sham device
389192|NCT01016964|O2|Outcome|LLT Device 2009 12 Beams|This is the active LLLT device
389193|NCT01016964|O1|Outcome|Sham Device|This control device emits white light
389194|NCT01016964|E2|Reported Event|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
389195|NCT01016964|E1|Reported Event|Sham Device|Sham device
389196|NCT01016938|B1|Baseline|Dynmaic Lung MRI|Lung Tumor Motion and Function
389197|NCT01016938|P1|Participant Flow|Dynamic Lung MRI|Lung Tumor Motion and Function
389198|NCT01016938|O1|Outcome|Dynamic Lung MRI|Lung Tumor Motion and Function
389199|NCT01016938|O1|Outcome|Lung Tumor Motion and Lung Function|This is a pilot study and there is only one group.
389200|NCT01016938|E1|Reported Event|Dynamic Lung MRI|Lung Tumor Motion and Function
389201|NCT01016912|B6|Baseline|Total|Total of all reporting groups
389202|NCT01016912|B5|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389203|NCT01016912|B4|Baseline|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389204|NCT01016912|B3|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389205|NCT01016912|B2|Baseline|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389206|NCT01016912|B1|Baseline|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389207|NCT01016912|P5|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389208|NCT01016912|P4|Participant Flow|Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389209|NCT01016912|P3|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389210|NCT01016912|P2|Participant Flow|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389211|NCT01016912|P1|Participant Flow|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389294|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389212|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389213|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389214|NCT01016912|O3|Outcome|Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive)|received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389215|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
389216|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
389217|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin
389218|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389219|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389220|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389221|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389222|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389223|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389224|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389225|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389226|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389227|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389228|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin..
389229|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389230|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
397067|NCT00999141|O5|Outcome|FS VH S/D 4 S-apr Side - Day 7|
389231|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
389232|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389233|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegINFα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389234|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389235|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
389236|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389237|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389238|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
389239|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389240|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
389241|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
389242|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389243|NCT01016912|O4|Outcome|Daclatasvir 10­ mg+ pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
389244|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
389245|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389246|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
389247|NCT01016912|E5|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
389248|NCT01016912|E4|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
389295|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
391015|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
389249|NCT01016912|E3|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
389250|NCT01016912|E2|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
389251|NCT01016912|E1|Reported Event|Placebo+pegIFNα +Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.
389252|NCT01016873|B4|Baseline|Total|Total of all reporting groups
389253|NCT01016873|B3|Baseline|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389254|NCT01016873|B2|Baseline|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389255|NCT01016873|B1|Baseline|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389256|NCT01016873|P3|Participant Flow|Sham IRay|"Sham 24 or 16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389257|NCT01016873|P2|Participant Flow|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389258|NCT01016873|P1|Participant Flow|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389259|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389260|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389261|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389262|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389263|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389264|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389265|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389266|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389267|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389268|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389269|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389270|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389271|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389272|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389273|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389274|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389275|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389276|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389277|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389278|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389279|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389280|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389281|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389282|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389283|NCT01016873|E3|Reported Event|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389284|NCT01016873|E2|Reported Event|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389285|NCT01016873|E1|Reported Event|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
389286|NCT01016847|B3|Baseline|Total|Total of all reporting groups
389287|NCT01016847|B2|Baseline|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
389288|NCT01016847|B1|Baseline|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389289|NCT01016847|P2|Participant Flow|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
389290|NCT01016847|P1|Participant Flow|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389291|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
389292|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389293|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
391016|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
389297|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
389298|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389299|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
389300|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389301|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
389302|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389303|NCT01016847|E2|Reported Event|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
389304|NCT01016847|E1|Reported Event|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
389305|NCT01016834|B1|Baseline|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
389306|NCT01016834|P1|Participant Flow|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
389307|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
389308|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
389309|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
389310|NCT01016834|E1|Reported Event|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
389311|NCT01016691|B4|Baseline|Total|Total of all reporting groups
389312|NCT01016691|B3|Baseline|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
389313|NCT01016691|B2|Baseline|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
389314|NCT01016691|B1|Baseline|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
389315|NCT01016691|P3|Participant Flow|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
389316|NCT01016691|P2|Participant Flow|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
389317|NCT01016691|P1|Participant Flow|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
389318|NCT01016691|O3|Outcome|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
389319|NCT01016691|O2|Outcome|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
389320|NCT01016691|O1|Outcome|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
389321|NCT01016691|E3|Reported Event|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
389322|NCT01016691|E2|Reported Event|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
389323|NCT01016691|E1|Reported Event|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
389324|NCT01016678|B1|Baseline|Adolescents Age 12-17|All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
389325|NCT01016678|P5|Participant Flow|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
389326|NCT01016678|P4|Participant Flow|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
389327|NCT01016678|P3|Participant Flow|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
389385|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
397068|NCT00999141|O4|Outcome|SoC Side - Day 3|
389328|NCT01016678|P2|Participant Flow|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
389329|NCT01016678|P1|Participant Flow|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
389330|NCT01016678|O5|Outcome|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
389331|NCT01016678|O4|Outcome|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
389332|NCT01016678|O3|Outcome|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
389333|NCT01016678|O2|Outcome|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
389334|NCT01016678|O1|Outcome|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
389335|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
389336|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
389337|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
389338|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
389339|NCT01016678|O4|Outcome|Migraine Attack 4|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
389340|NCT01016678|O3|Outcome|Migraine Attack 3|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
389341|NCT01016678|O2|Outcome|Migraine Attack 2|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
389342|NCT01016678|O1|Outcome|Migraine Attack 1|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
389343|NCT01016678|E5|Reported Event|Active, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
389344|NCT01016678|E4|Reported Event|Placebo, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
389345|NCT01016678|E3|Reported Event|Active, Placebo, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
389346|NCT01016678|E2|Reported Event|Active, Active, Placebo, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
389347|NCT01016678|E1|Reported Event|Active, Active, Active, Placebo|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
389348|NCT01016652|B3|Baseline|Total|Total of all reporting groups
397069|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Day 3|
389349|NCT01016652|B2|Baseline|Etafilcon A Sphere\ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
389350|NCT01016652|B1|Baseline|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
389351|NCT01016652|P2|Participant Flow|Etafilcon A Sphere/ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
389352|NCT01016652|P1|Participant Flow|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
389353|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
389354|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
389355|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
389356|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
389357|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
389358|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
389359|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
389360|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
389361|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
389362|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
389363|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere worn
389364|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal worn.
389365|NCT01016652|E2|Reported Event|Etafilcon A Sphere|etafilcon A sphere worn
389366|NCT01016652|E1|Reported Event|Etafilcon A Multifocal|etafilcon A multifocal worn
389367|NCT01016600|B5|Baseline|Total|Total of all reporting groups
389368|NCT01016600|B4|Baseline|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389369|NCT01016600|B3|Baseline|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389370|NCT01016600|B2|Baseline|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389371|NCT01016600|B1|Baseline|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389372|NCT01016600|P4|Participant Flow|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389373|NCT01016600|P3|Participant Flow|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389374|NCT01016600|P2|Participant Flow|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389375|NCT01016600|P1|Participant Flow|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389376|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389377|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389378|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389379|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389380|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389381|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389382|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389383|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389384|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389678|NCT01015677|P2|Participant Flow|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389386|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389387|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389388|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389389|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389390|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389391|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389392|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389393|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389394|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389395|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389396|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389397|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389398|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389399|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389400|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389401|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389402|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389403|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389404|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389405|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389406|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389407|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389408|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389409|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389410|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389411|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389412|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389413|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389414|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389679|NCT01015677|P1|Participant Flow|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389415|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389416|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389417|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389418|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389419|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389420|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389421|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389422|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389423|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389424|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389425|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389426|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389427|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389428|NCT01016600|O1|Outcome|Phase I Cohort|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389429|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389430|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389431|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389432|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389433|NCT01016600|E4|Reported Event|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389434|NCT01016600|E3|Reported Event|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389435|NCT01016600|E2|Reported Event|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389436|NCT01016600|E1|Reported Event|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
389437|NCT01016483|B5|Baseline|Total|Total of all reporting groups
389438|NCT01016483|B4|Baseline|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389439|NCT01016483|B3|Baseline|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389440|NCT01016483|B2|Baseline|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389441|NCT01016483|B1|Baseline|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389567|NCT01016106|P1|Participant Flow|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
389442|NCT01016483|P4|Participant Flow|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389443|NCT01016483|P3|Participant Flow|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389444|NCT01016483|P2|Participant Flow|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks) (bid continuous regimen).
389445|NCT01016483|P1|Participant Flow|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389446|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389447|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389448|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389449|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389450|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389451|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389452|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389453|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389454|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389455|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389456|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389457|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389458|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389459|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389460|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389461|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389680|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389462|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389463|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389464|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389465|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389466|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389467|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389468|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389469|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389470|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389471|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389472|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389473|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389474|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389475|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389476|NCT01016483|O2|Outcome|Regimen 1: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389477|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389478|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389479|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389480|NCT01016483|O6|Outcome|Regimen1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389481|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389482|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389483|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389484|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389485|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389486|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389487|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389488|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389489|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389490|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389491|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389492|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389493|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389494|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389495|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389496|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389497|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389498|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389499|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389500|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389501|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389568|NCT01016106|O2|Outcome|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
389502|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389503|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389504|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389505|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389506|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389507|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389508|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389509|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389510|NCT01016483|O6|Outcome|Regimen1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389511|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389512|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389513|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389514|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389515|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389516|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389517|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389518|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389519|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389520|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389569|NCT01016106|O1|Outcome|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
389521|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389522|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 120 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389523|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 90 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389524|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 68 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
389525|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389526|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389527|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389528|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389529|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389530|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389531|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389532|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389533|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389534|NCT01016483|O2|Outcome|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389535|NCT01016483|O1|Outcome|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389536|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
389537|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
389538|NCT01016483|O8|Outcome|Safety Run-in Part Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389539|NCT01016483|O7|Outcome|Safety Run-in Part Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
389570|NCT01016106|E2|Reported Event|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
389540|NCT01016483|O6|Outcome|Safety Run-in Part Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389541|NCT01016483|O5|Outcome|Safety Run-in Part Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389542|NCT01016483|O4|Outcome|Safety Run-in Part Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389543|NCT01016483|O3|Outcome|Safety Run-in Part Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389544|NCT01016483|O2|Outcome|Safety Run-in Part Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389545|NCT01016483|O1|Outcome|Safety Run-in Part Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389546|NCT01016483|E4|Reported Event|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib orally 60 mg bid - continuous regimen.
389547|NCT01016483|E3|Reported Event|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib orally 60 mg bid - continuous regimen.
389548|NCT01016483|E2|Reported Event|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389549|NCT01016483|E1|Reported Event|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
389550|NCT01016353|B3|Baseline|Total|Total of all reporting groups
389551|NCT01016353|B2|Baseline|BVPT|Barker's vacuum-packing technique (BVPT)
389552|NCT01016353|B1|Baseline|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
389553|NCT01016353|P2|Participant Flow|BVPT|Barker's vacuum-packing technique (BVPT)
389554|NCT01016353|P1|Participant Flow|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
389555|NCT01016353|O2|Outcome|BVPT|Barker's vacuum-packing technique (BVPT)
389556|NCT01016353|O1|Outcome|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
389557|NCT01016353|E2|Reported Event|BVPT|Barker's vacuum-packing technique (BVPT)
389558|NCT01016353|E1|Reported Event|NPWT|ABThera Open Abdomen Negative Pressure Therapy System
389559|NCT01016132|B1|Baseline|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
389560|NCT01016132|P1|Participant Flow|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
389561|NCT01016132|O1|Outcome|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
389562|NCT01016132|E1|Reported Event|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
389563|NCT01016106|B3|Baseline|Total|Total of all reporting groups
389564|NCT01016106|B2|Baseline|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
389565|NCT01016106|B1|Baseline|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
389566|NCT01016106|P2|Participant Flow|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
389681|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389571|NCT01016106|E1|Reported Event|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
389572|NCT01016067|B3|Baseline|Total|Total of all reporting groups
389573|NCT01016067|B2|Baseline|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389574|NCT01016067|B1|Baseline|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389575|NCT01016067|P2|Participant Flow|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389576|NCT01016067|P1|Participant Flow|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389577|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389578|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389579|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389580|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389581|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389582|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389583|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389584|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389585|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389586|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389587|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389588|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389589|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389590|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389591|NCT01016067|E2|Reported Event|Autograft Bone|Patients received autograft bone with rigid internal fixation.
389592|NCT01016067|E1|Reported Event|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
389593|NCT01016015|B1|Baseline|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
389594|NCT01016015|P1|Participant Flow|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
389595|NCT01016015|O1|Outcome|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
389596|NCT01016015|E1|Reported Event|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
389597|NCT01015976|B1|Baseline|Active Drug|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
389598|NCT01015976|P2|Participant Flow|Control Group|"active drug~No surgery matched subjects"
389599|NCT01015976|P1|Participant Flow|Experimental|Post surgery group Sertraline : Single dose of 100mg sertraline
389600|NCT01015976|O1|Outcome|Control|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
389601|NCT01015976|E1|Reported Event|Active Drug|"Two arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
389602|NCT01015833|B3|Baseline|Total|Total of all reporting groups
389603|NCT01015833|B2|Baseline|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389604|NCT01015833|B1|Baseline|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389605|NCT01015833|P2|Participant Flow|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389606|NCT01015833|P1|Participant Flow|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389607|NCT01015833|O2|Outcome|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389608|NCT01015833|O1|Outcome|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389609|NCT01015833|O2|Outcome|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389636|NCT01015807|P1|Participant Flow|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
389610|NCT01015833|O1|Outcome|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389611|NCT01015833|O2|Outcome|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389612|NCT01015833|O1|Outcome|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389613|NCT01015833|O2|Outcome|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389614|NCT01015833|O1|Outcome|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389615|NCT01015833|O2|Outcome|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389616|NCT01015833|O1|Outcome|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389617|NCT01015833|E2|Reported Event|Arm II (Sorafenib Tosylate)|Patients receive 400 mg sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
389618|NCT01015833|E1|Reported Event|Arm I (Doxorubicin Hydrochloride, Sorafenib Tosylate)|Patients receive 60 mg/m2 doxorubicin hydrochloride IV on day 1 and 400 mg sorafenib tosylate PO QD or BID on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity.
389619|NCT01015820|B3|Baseline|Total|Total of all reporting groups
389620|NCT01015820|B2|Baseline|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389621|NCT01015820|B1|Baseline|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389622|NCT01015820|P2|Participant Flow|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389623|NCT01015820|P1|Participant Flow|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.
389624|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389625|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389626|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389627|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389628|NCT01015820|E2|Reported Event|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389629|NCT01015820|E1|Reported Event|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
389630|NCT01015807|B4|Baseline|Total|Total of all reporting groups
389631|NCT01015807|B3|Baseline|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
389632|NCT01015807|B2|Baseline|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
389633|NCT01015807|B1|Baseline|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
389634|NCT01015807|P3|Participant Flow|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
389635|NCT01015807|P2|Participant Flow|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
389637|NCT01015807|O3|Outcome|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
389638|NCT01015807|O2|Outcome|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
389639|NCT01015807|O1|Outcome|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
389640|NCT01015807|E3|Reported Event|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
389641|NCT01015807|E2|Reported Event|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
389642|NCT01015807|E1|Reported Event|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
389643|NCT01015781|B3|Baseline|Total|Total of all reporting groups
389644|NCT01015781|B2|Baseline|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
389645|NCT01015781|B1|Baseline|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
389646|NCT01015781|P2|Participant Flow|Wait List Control|Wait List Control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
389647|NCT01015781|P1|Participant Flow|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
389648|NCT01015781|O2|Outcome|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
389649|NCT01015781|O1|Outcome|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
389650|NCT01015781|E2|Reported Event|Wait List Control|Wait List control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
389651|NCT01015781|E1|Reported Event|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
389652|NCT01015703|B6|Baseline|Total|Total of all reporting groups
389653|NCT01015703|B5|Baseline|10 mg Dose|10 mg CoVaccine HT
389654|NCT01015703|B4|Baseline|7 mg Dose|7 mg CoVaccine HT
389655|NCT01015703|B3|Baseline|5 mg Dose|5 mg CoVaccine HT
389656|NCT01015703|B2|Baseline|2 mg Dose|2 mg CoVaccine HT
389657|NCT01015703|B1|Baseline|1 mg Dose|1 mg CoVaccine HT
389658|NCT01015703|P5|Participant Flow|10 mg Dose|10 mg CoVaccine HT
389659|NCT01015703|P4|Participant Flow|7 mg Dose|7 mg CoVaccine HT
389660|NCT01015703|P3|Participant Flow|5 mg Dose|5 mg CoVaccine HT
389661|NCT01015703|P2|Participant Flow|2 mg Dose|2 mg CoVaccine HT
389662|NCT01015703|P1|Participant Flow|1 mg Dose|1 mg CoVaccine HT
389663|NCT01015703|O5|Outcome|10 mg Dose|10 mg CoVaccine HT
389664|NCT01015703|O4|Outcome|7 mg Dose|7 mg CoVaccine HT
389665|NCT01015703|O3|Outcome|5 mg Dose|5 mg CoVaccine HT
389666|NCT01015703|O2|Outcome|2 mg Dose|2 mg CoVaccine HT
389667|NCT01015703|O1|Outcome|1 mg Dose|1 mg CoVaccine HT
389668|NCT01015703|E5|Reported Event|10 mg Dose|10 mg CoVaccine HT
389669|NCT01015703|E4|Reported Event|7 mg Dose|7 mg CoVaccine HT
389670|NCT01015703|E3|Reported Event|5 mg Dose|5 mg CoVaccine HT
389671|NCT01015703|E2|Reported Event|2 mg Dose|2 mg CoVaccine HT
389672|NCT01015703|E1|Reported Event|1 mg Dose|1 mg CoVaccine HT
389673|NCT01015677|B4|Baseline|Total|Total of all reporting groups
389674|NCT01015677|B3|Baseline|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389675|NCT01015677|B2|Baseline|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389676|NCT01015677|B1|Baseline|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389683|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389684|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389685|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389686|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389687|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389688|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389689|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389690|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389691|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389692|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389693|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389694|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389695|NCT01015677|E3|Reported Event|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389696|NCT01015677|E2|Reported Event|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
389697|NCT01015677|E1|Reported Event|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
389698|NCT01015638|B3|Baseline|Total|Total of all reporting groups
389699|NCT01015638|B2|Baseline|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389700|NCT01015638|B1|Baseline|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389701|NCT01015638|P2|Participant Flow|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389702|NCT01015638|P1|Participant Flow|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389703|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389704|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389705|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389706|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389707|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389708|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389709|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389710|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389711|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389712|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389713|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389714|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389715|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389716|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389717|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389718|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389719|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389720|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389721|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389722|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389723|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389724|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389725|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389726|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389727|NCT01015638|E2|Reported Event|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
389728|NCT01015638|E1|Reported Event|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
389729|NCT01015560|B1|Baseline|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
389730|NCT01015560|P1|Participant Flow|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
389731|NCT01015560|O1|Outcome|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
389732|NCT01015560|E1|Reported Event|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
389733|NCT01015534|B3|Baseline|Total|Total of all reporting groups
389734|NCT01015534|B2|Baseline|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
389735|NCT01015534|B1|Baseline|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
389736|NCT01015534|P2|Participant Flow|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
389737|NCT01015534|P1|Participant Flow|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
389738|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
389739|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks,and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
389740|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
389741|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
389742|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
389743|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
389744|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
389745|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
389746|NCT01015534|E2|Reported Event|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
389747|NCT01015534|E1|Reported Event|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
389748|NCT01015443|B3|Baseline|Total|Total of all reporting groups
389749|NCT01015443|B2|Baseline|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389750|NCT01015443|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389751|NCT01015443|P2|Participant Flow|Saline + Placebo + BSC|A single IV infusion of 0.9 percent (%) sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389752|NCT01015443|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care|A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 microgram (mcg) and then at 6-Week interval, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinued for any other reason. The best supportive care (BSC) was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389753|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389754|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389755|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389756|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389757|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389758|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389759|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389760|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389761|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389762|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389763|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389839|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389764|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389765|NCT01015443|E2|Reported Event|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389766|NCT01015443|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
389767|NCT01015326|B3|Baseline|Total|Total of all reporting groups
389768|NCT01015326|B2|Baseline|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
389769|NCT01015326|B1|Baseline|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
389770|NCT01015326|P2|Participant Flow|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked through interview and questionnaire to rate items according to how important they are to the patient's health-related quality of life (HRQL).~Questionnaire : Administered questionnaire"
389771|NCT01015326|P1|Participant Flow|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
389772|NCT01015326|O2|Outcome|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
389773|NCT01015326|O1|Outcome|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
389774|NCT01015326|E2|Reported Event|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
389775|NCT01015326|E1|Reported Event|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
389776|NCT01015287|B3|Baseline|Total|Total of all reporting groups
389777|NCT01015287|B2|Baseline|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
390085|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
389778|NCT01015287|B1|Baseline|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389779|NCT01015287|P2|Participant Flow|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389780|NCT01015287|P1|Participant Flow|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389781|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389782|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389783|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389784|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389785|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389786|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389787|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389788|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389789|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389790|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389791|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389792|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389793|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389794|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389795|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389796|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389797|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389798|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389799|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389800|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389801|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389802|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389803|NCT01015287|E2|Reported Event|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
390086|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
389804|NCT01015287|E1|Reported Event|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
389805|NCT01015170|B1|Baseline|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
389806|NCT01015170|P1|Participant Flow|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.~bupropion HCl: 150mg BID for up to 8 weeks + counseling"
389807|NCT01015170|O1|Outcome|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
389808|NCT01015170|O1|Outcome|Bupropion HCl and Counselling|Bupropion HCl Up to 8 week of bupropion SR (150mg BID) + counseling.
389809|NCT01015170|O1|Outcome|Nicotine Replacement & Behavioural Support|"Nicotine Replacement Therapy: Transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge~& Smoking cessation counselling-relapse prevention strategies."
389810|NCT01015170|E1|Reported Event|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.~bupropion HCl: 150mg BID for up to 8 weeks + counseling"
389811|NCT01015131|B1|Baseline|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389812|NCT01015131|P1|Participant Flow|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389813|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389814|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389815|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389816|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389817|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389818|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389819|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389820|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389821|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389822|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389823|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389824|NCT01015131|E1|Reported Event|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
389825|NCT01015118|B3|Baseline|Total|Total of all reporting groups
389826|NCT01015118|B2|Baseline|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389827|NCT01015118|B1|Baseline|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389828|NCT01015118|P2|Participant Flow|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389829|NCT01015118|P1|Participant Flow|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389830|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389831|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389832|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389833|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389834|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389835|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389836|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389837|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389838|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389840|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389841|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389842|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389843|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389844|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389845|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389846|NCT01015118|O2|Outcome|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389847|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389848|NCT01015118|E2|Reported Event|Nintedanib|Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389849|NCT01015118|E1|Reported Event|Placebo|Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
389850|NCT01014988|B7|Baseline|Total|Total of all reporting groups
389851|NCT01014988|B6|Baseline|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389852|NCT01014988|B5|Baseline|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389853|NCT01014988|B4|Baseline|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389854|NCT01014988|B3|Baseline|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389855|NCT01014988|B2|Baseline|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389856|NCT01014988|B1|Baseline|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389857|NCT01014988|P6|Participant Flow|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389858|NCT01014988|P5|Participant Flow|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389859|NCT01014988|P4|Participant Flow|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389860|NCT01014988|P3|Participant Flow|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389861|NCT01014988|P2|Participant Flow|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389862|NCT01014988|P1|Participant Flow|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 milligrams (mg) zanamivir by intravenous (IV) infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390087|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
389863|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389864|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389865|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389866|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389867|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389868|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389869|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389870|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389871|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389872|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389873|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389874|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389875|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389876|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389877|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389878|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389879|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389880|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389881|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389882|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389883|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389884|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389885|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389886|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389887|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389888|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389889|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389890|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389891|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389892|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389893|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389894|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389895|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389896|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389897|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389898|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389899|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389900|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389901|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389902|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389903|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389904|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389905|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389906|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389907|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389908|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389909|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389910|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389911|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389912|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389913|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389914|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389915|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389916|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389917|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389918|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389919|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389920|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389921|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389922|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389923|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389924|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389925|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389926|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389927|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389928|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389929|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389930|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389931|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389932|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389933|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389934|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389935|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389936|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389937|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389938|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389939|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389940|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389941|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389942|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389943|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389944|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389945|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389946|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389947|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389948|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389949|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389950|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389951|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389952|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389953|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389954|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389955|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389956|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389957|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389958|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389959|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389960|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389961|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389962|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
397070|NCT00999141|O2|Outcome|SoC Side - Day 1|
389963|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389964|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389965|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389966|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
389967|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
389968|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389969|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389970|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389971|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389972|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389973|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389974|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389975|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389976|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389977|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389978|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389979|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
389980|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
389981|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389982|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390049|NCT01014936|P1|Participant Flow|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
389983|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389984|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389985|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389986|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
389987|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
389988|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389989|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389990|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389991|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389992|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389993|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
389994|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
389995|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389996|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389997|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389998|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
389999|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390000|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
390001|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
390002|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390003|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
391017|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
390004|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390005|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390006|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390007|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
390008|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
390009|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390010|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390011|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390012|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390013|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390014|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390015|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390016|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390017|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390018|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390019|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390020|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390021|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390084|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390022|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390023|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390024|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390025|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390026|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390027|NCT01014988|E6|Reported Event|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390028|NCT01014988|E5|Reported Event|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390029|NCT01014988|E4|Reported Event|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390030|NCT01014988|E3|Reported Event|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390031|NCT01014988|E2|Reported Event|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390032|NCT01014988|E1|Reported Event|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
390033|NCT01014975|B1|Baseline|Safety Population|Plasmin (Human): Plasmin (Human), 20 mg, 40 mg, or 80 mg, delivered through a catheter into a thrombus
390034|NCT01014975|P3|Participant Flow|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
390035|NCT01014975|P2|Participant Flow|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
390036|NCT01014975|P1|Participant Flow|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
390037|NCT01014975|O3|Outcome|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
390038|NCT01014975|O2|Outcome|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
390039|NCT01014975|O1|Outcome|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
390040|NCT01014975|E3|Reported Event|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
390041|NCT01014975|E2|Reported Event|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
390042|NCT01014975|E1|Reported Event|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
390043|NCT01014936|B4|Baseline|Total|Total of all reporting groups
390044|NCT01014936|B3|Baseline|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390045|NCT01014936|B2|Baseline|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390046|NCT01014936|B1|Baseline|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390047|NCT01014936|P3|Participant Flow|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390048|NCT01014936|P2|Participant Flow|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390050|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390051|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390052|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390053|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390054|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390055|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390056|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390057|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390058|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390059|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390060|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390061|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390062|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390063|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390064|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390065|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390066|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390067|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390068|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390069|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390070|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390071|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390072|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390073|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390074|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390075|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390076|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390077|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390078|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390079|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390080|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390081|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390082|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390083|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390088|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390089|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390090|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390091|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390092|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390093|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390094|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390095|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390096|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390097|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390098|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
390099|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390100|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390101|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390102|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390103|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390104|NCT01014936|O9|Outcome|MSC2156119J 115 mg Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390105|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390106|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390107|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390108|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390109|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390110|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390111|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390112|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390113|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390114|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390115|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390116|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390117|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390118|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390119|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390120|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390121|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390122|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390123|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390124|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390125|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390126|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390127|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390128|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390129|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390130|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390131|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
397071|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Day 1|
390132|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390133|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390134|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390135|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390136|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390137|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390138|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390139|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390140|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390141|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390142|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390143|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390144|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390145|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390146|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390147|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390148|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390149|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390150|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390151|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390152|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390153|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390154|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390155|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
390156|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390157|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390158|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390159|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390160|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390161|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390162|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390163|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390164|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390165|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390166|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390167|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390168|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390169|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390170|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390171|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390172|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390173|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390174|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390175|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390176|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390177|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390178|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390179|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390180|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390181|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390182|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390183|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390184|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
390185|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390186|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390187|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390188|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390189|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390190|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390191|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390192|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390193|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390194|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390195|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390196|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390197|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390198|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390199|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390200|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390201|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390202|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390203|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390204|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390205|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390206|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390207|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390208|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390209|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390210|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390211|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390212|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390213|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390214|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390215|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390216|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390217|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390218|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390219|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
399334|NCT00996281|B3|Baseline|Total|Total of all reporting groups
390220|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390221|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390222|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390223|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390224|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390225|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390226|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390227|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390228|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390229|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390230|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390231|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390232|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390233|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390234|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390235|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390236|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390237|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390238|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390239|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390240|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390241|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
390242|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390243|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390244|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390245|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390246|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390247|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390248|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390249|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390250|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390251|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390252|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390253|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390254|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390255|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390256|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390257|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390258|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390259|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390260|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390261|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390262|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390263|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390264|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390265|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390266|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390267|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390268|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (Tablet) with food.
390269|NCT01014936|O7|Outcome|MSC2156119J 1400 mg Fed|Subjects were administered with micronized MSC2156119J 1400 mg with food.
390270|NCT01014936|O6|Outcome|MSC2156119J 1200 mg Fasted|Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state.
390271|NCT01014936|O5|Outcome|MSC2156119J 1000 mg Fed|Subjects were administered with micronized MSC2156119J 1000 mg with food.
390272|NCT01014936|O4|Outcome|MSC2156119J 700 mg Fed|Subjects were administered with micronized MSC2156119J 700 mg with food.
390273|NCT01014936|O3|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food
390274|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg in the fasted state.
390275|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food
390276|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390277|NCT01014936|O8|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390278|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390279|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390280|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390281|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390282|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390283|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390284|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390285|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390286|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390287|NCT01014936|O10|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390288|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390289|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390290|NCT01014936|O7|Outcome|MSC2156119J 400 mg Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390291|NCT01014936|O6|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390292|NCT01014936|O5|Outcome|MSC2156119J 215 mg Fed|Subjects were administered with micronized MSC2156119J 215 mg with food.
390293|NCT01014936|O4|Outcome|MSC2156119J 145 mg Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390294|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390295|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390296|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390297|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390298|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390299|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390300|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390301|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390302|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390303|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390304|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390305|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390306|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390307|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390308|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
399889|NCT00994448|B3|Baseline|Total|Total of all reporting groups
390309|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390310|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390311|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390312|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390313|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390314|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390315|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390316|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390317|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390318|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390319|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390320|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390321|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390322|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390323|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390324|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390325|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390326|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390327|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
390328|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390329|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390330|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390331|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390332|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390333|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390334|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390335|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390336|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390337|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390338|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390339|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390340|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390341|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390342|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390343|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390344|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390345|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg in the fasted state.
390346|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390347|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390348|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390349|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390350|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390351|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390352|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
404524|NCT00984308|O1|Outcome|Intervention|
390353|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390354|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390355|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390356|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390357|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390358|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390359|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390360|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390361|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390362|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390363|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390364|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390365|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390366|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390367|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390368|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390369|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390370|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390371|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390372|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390373|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390374|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390375|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390376|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390377|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390378|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390379|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390380|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390381|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food
390382|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet) with food.
390383|NCT01014936|O7|Outcome|MSC2156119J 1400 mg Fed|Subjects were administered with micronized MSC2156119J 1400 mg with food.
390384|NCT01014936|O6|Outcome|MSC2156119J 1200 mg Fasted|Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state.
390385|NCT01014936|O5|Outcome|MSC2156119J 1000 mg Fed|Subjects were administered with micronized MSC2156119J 1000 mg with food.
390386|NCT01014936|O4|Outcome|MSC2156119J 700 mg Fed|Subjects were administered with micronized MSC2156119J 700 mg with food.
390387|NCT01014936|O3|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food.
390388|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg in the fasted state.
390389|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food.
390390|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390391|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390392|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390393|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390394|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390395|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390396|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390397|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
404525|NCT00984308|O2|Outcome|Control|
390398|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390399|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390400|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390401|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390402|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390403|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state
390404|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390405|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390406|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390407|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390408|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390409|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390410|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390411|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390412|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390413|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390414|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390415|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390416|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390417|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390418|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390419|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390420|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390421|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390422|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390423|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390424|NCT01014936|O3|Outcome|MSC2156119J 130 mg Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390425|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390426|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390427|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390428|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390429|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390430|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390431|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390432|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390433|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390434|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390435|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390436|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390437|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390438|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390439|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390440|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390441|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
390442|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390443|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390444|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390445|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390446|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390447|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390448|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390449|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390450|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390451|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390452|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390453|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390454|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390455|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390456|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390457|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390458|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390459|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390460|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390461|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390462|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390463|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390464|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390465|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390466|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390467|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390468|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390469|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390470|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390471|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390472|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390473|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390474|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390475|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390476|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390477|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390478|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390479|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390480|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390481|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390482|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390483|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390484|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390485|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390486|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390487|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390488|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390489|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390490|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390491|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390492|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390493|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390494|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390495|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390496|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
390497|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
390498|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
390499|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
390500|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
390501|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
390502|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
390503|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390504|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390505|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390506|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390507|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390508|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
390509|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
390510|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
390511|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390512|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390513|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
390514|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
390515|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
390516|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
390517|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
390518|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
390519|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
390520|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
390521|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
390522|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
390523|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
390524|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
390525|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390526|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390527|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
391018|NCT01013844|E2|Reported Event|Dyadic Learning|Participant and partner learning together.
390528|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390529|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390530|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390531|NCT01014936|O1|Outcome|MSC2156119J Combined|All subjects who were administered with micronized or non-micronized MSC2156119J (capsule or tablet formulation) in any of the three regimens.
390532|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390533|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390534|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390535|NCT01014936|E3|Reported Event|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
390536|NCT01014936|E2|Reported Event|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
390537|NCT01014936|E1|Reported Event|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
390538|NCT01014910|B3|Baseline|Total|Total of all reporting groups
390539|NCT01014910|B2|Baseline|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
390540|NCT01014910|B1|Baseline|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
390541|NCT01014910|P2|Participant Flow|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
390542|NCT01014910|P1|Participant Flow|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
390543|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
390544|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
390545|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
390546|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
390547|NCT01014910|E2|Reported Event|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
390548|NCT01014910|E1|Reported Event|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
390549|NCT01014871|B1|Baseline|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
390550|NCT01014871|P1|Participant Flow|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
390551|NCT01014871|O2|Outcome|Vistabel|"at Baseline:~- 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
390552|NCT01014871|O1|Outcome|Azzalure|"at Baseline:~- 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead"
390553|NCT01014871|E2|Reported Event|Vistabel|intra-individual comparison
390554|NCT01014871|E1|Reported Event|Azzalure|intra-individual comparison
390555|NCT01014741|B3|Baseline|Total|Total of all reporting groups
390556|NCT01014741|B2|Baseline|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
390557|NCT01014741|B1|Baseline|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
390558|NCT01014741|P2|Participant Flow|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
390559|NCT01014741|P1|Participant Flow|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation
390560|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
390561|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
390562|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
390563|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
390564|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
390565|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
390566|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
390567|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
390568|NCT01014741|E2|Reported Event|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
390569|NCT01014741|E1|Reported Event|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
390570|NCT01014728|B3|Baseline|Total|Total of all reporting groups
390571|NCT01014728|B2|Baseline|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
390572|NCT01014728|B1|Baseline|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
390573|NCT01014728|P2|Participant Flow|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
390574|NCT01014728|P1|Participant Flow|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
390575|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
390576|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
390577|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
390578|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
390579|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
390580|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
390581|NCT01014728|E2|Reported Event|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
390582|NCT01014728|E1|Reported Event|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
390583|NCT01014689|B3|Baseline|Total|Total of all reporting groups
391019|NCT01013844|E1|Reported Event|Solo Learning|Participant learning alone (without partner).
390584|NCT01014689|B2|Baseline|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390585|NCT01014689|B1|Baseline|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390586|NCT01014689|P2|Participant Flow|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390587|NCT01014689|P1|Participant Flow|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390588|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390589|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390590|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390591|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390592|NCT01014689|E2|Reported Event|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390593|NCT01014689|E1|Reported Event|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
390594|NCT01014624|B3|Baseline|Total|Total of all reporting groups
390595|NCT01014624|B2|Baseline|Clopidogrel|Clopidogrel 75 mg tablet daily
390596|NCT01014624|B1|Baseline|Prasugrel|Prasugrel 10 mg tablet daily
390597|NCT01014624|P2|Participant Flow|Clopidogrel|Clopidogrel 75 mg daily
390598|NCT01014624|P1|Participant Flow|Prasugrel|Prasugrel 10 mg daily
390599|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
390600|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
390601|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
390602|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
390603|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
390604|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
390605|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
390606|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
390607|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
390608|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
390609|NCT01014624|O2|Outcome|Clopidogrel|Clopidogrel 75 mg tablet daily
390610|NCT01014624|O1|Outcome|Prasugrel|Prasugrel 10 mg tablet daily
390611|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
390612|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
390613|NCT01014624|O2|Outcome|Clopidogrel 75 mg Daily|
390614|NCT01014624|O1|Outcome|Prasugrel 10 mg Daily|
390615|NCT01014624|E2|Reported Event|Clopidogrel 75mg/ Daily|
390616|NCT01014624|E1|Reported Event|Prasugrel 10 mg/Daily|
390617|NCT01014585|B5|Baseline|Total|Total of all reporting groups
390618|NCT01014585|B4|Baseline|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population."
390619|NCT01014585|B3|Baseline|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
390620|NCT01014585|B2|Baseline|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
390621|NCT01014585|B1|Baseline|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
390622|NCT01014585|P4|Participant Flow|Non-Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Non-Responders
390623|NCT01014585|P3|Participant Flow|Non-Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Non-Responders
390624|NCT01014585|P2|Participant Flow|Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Responders
390625|NCT01014585|P1|Participant Flow|Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Responders
390626|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
390627|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
390628|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
390629|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
390630|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
390631|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
390632|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
390633|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
390634|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
390635|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
390636|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
390637|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
390638|NCT01014585|E4|Reported Event|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double blind investigational product and therefore was not included in the Safety population."
390639|NCT01014585|E3|Reported Event|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
390640|NCT01014585|E2|Reported Event|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
390641|NCT01014585|E1|Reported Event|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
390642|NCT01014533|B3|Baseline|Total|Total of all reporting groups
390643|NCT01014533|B2|Baseline|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
390644|NCT01014533|B1|Baseline|Placebo|"Alcohol-dependent subjects spend 3 nights in the University of Michigan (UM) sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the University of Michigan (UM) Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
390645|NCT01014533|P2|Participant Flow|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 -2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
390646|NCT01014533|P1|Participant Flow|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
390647|NCT01014533|O2|Outcome|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
390648|NCT01014533|O1|Outcome|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
390649|NCT01014533|O2|Outcome|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
390650|NCT01014533|O1|Outcome|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
390651|NCT01014533|O2|Outcome|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
390821|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
390652|NCT01014533|O1|Outcome|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
390653|NCT01014533|E2|Reported Event|Gabapentin|Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8 -10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
390654|NCT01014533|E1|Reported Event|Placebo|"Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.~Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared."
390655|NCT01014455|B3|Baseline|Total|Total of all reporting groups
390656|NCT01014455|B2|Baseline|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
390657|NCT01014455|B1|Baseline|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
390658|NCT01014455|P2|Participant Flow|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
390659|NCT01014455|P1|Participant Flow|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
390660|NCT01014455|O2|Outcome|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
390661|NCT01014455|O1|Outcome|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
390662|NCT01014455|E2|Reported Event|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
390663|NCT01014455|E1|Reported Event|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
390664|NCT01014442|B3|Baseline|Total|Total of all reporting groups
390665|NCT01014442|B2|Baseline|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390666|NCT01014442|B1|Baseline|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390667|NCT01014442|P2|Participant Flow|MMF - COPD, Emphysema, IPF, or A1AD|Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390668|NCT01014442|P1|Participant Flow|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390669|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
390670|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390671|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
390672|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390673|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
390674|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390675|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
390676|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390677|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
390678|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390679|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390680|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390681|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390682|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390683|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390684|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390685|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390686|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390687|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390688|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390689|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390690|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390691|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390692|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390693|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390694|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390695|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390696|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390697|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390698|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390699|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390700|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390701|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390702|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390703|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
391020|NCT01013792|B3|Baseline|Total|Total of all reporting groups
390704|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390705|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390706|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390707|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390708|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390709|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390710|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390711|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390712|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390713|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390714|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390715|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390716|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390717|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390718|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390719|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390720|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390721|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390722|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390723|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390724|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390725|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390726|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390727|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390728|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390729|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
391881|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
390730|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390731|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390732|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390733|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390734|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390735|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390736|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390737|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390738|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390739|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390740|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390741|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390742|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390743|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390744|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390745|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390746|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390747|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390748|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390749|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390750|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390751|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390752|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390753|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390754|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390755|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390756|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390757|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390758|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390759|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390760|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390761|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390762|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390763|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390764|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390765|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390766|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390767|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390768|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390769|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390770|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390771|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390772|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390773|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390774|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390775|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390776|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390777|NCT01014442|E2|Reported Event|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
390778|NCT01014442|E1|Reported Event|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
390779|NCT01014351|B1|Baseline|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
390780|NCT01014351|P1|Participant Flow|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
390781|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
390782|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
390783|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
390784|NCT01014351|E1|Reported Event|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
390785|NCT01014208|B3|Baseline|Total|Total of all reporting groups
390786|NCT01014208|B2|Baseline|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390787|NCT01014208|B1|Baseline|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390788|NCT01014208|P2|Participant Flow|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390789|NCT01014208|P1|Participant Flow|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390790|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390818|NCT01014169|P1|Participant Flow|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
390819|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
390820|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
391069|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
390791|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390792|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390793|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390794|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390795|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390796|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390797|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390798|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390799|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390800|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390801|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390802|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390803|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390804|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390805|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390806|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390807|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390808|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390809|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390810|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390811|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390812|NCT01014208|E2|Reported Event|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390813|NCT01014208|E1|Reported Event|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
390814|NCT01014169|B3|Baseline|Total|Total of all reporting groups
390815|NCT01014169|B2|Baseline|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
390816|NCT01014169|B1|Baseline|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
390817|NCT01014169|P2|Participant Flow|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
390822|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
390823|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
390824|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
390825|NCT01014169|E2|Reported Event|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
390826|NCT01014169|E1|Reported Event|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
390827|NCT01014143|B4|Baseline|Total|Total of all reporting groups
390828|NCT01014143|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
390829|NCT01014143|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
390830|NCT01014143|B1|Baseline|Fluoride Toothpaste|negative control
390831|NCT01014143|P3|Participant Flow|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
390832|NCT01014143|P2|Participant Flow|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
390833|NCT01014143|P1|Participant Flow|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
390834|NCT01014143|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
390835|NCT01014143|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
390836|NCT01014143|O1|Outcome|Fluoride Toothpaste|negative control
390837|NCT01014143|E3|Reported Event|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
390838|NCT01014143|E2|Reported Event|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
390839|NCT01014143|E1|Reported Event|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
390840|NCT01014091|B7|Baseline|Total|Total of all reporting groups
390841|NCT01014091|B6|Baseline|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390842|NCT01014091|B5|Baseline|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390843|NCT01014091|B4|Baseline|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390844|NCT01014091|B3|Baseline|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390845|NCT01014091|B2|Baseline|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390846|NCT01014091|B1|Baseline|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390847|NCT01014091|P6|Participant Flow|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390848|NCT01014091|P5|Participant Flow|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390849|NCT01014091|P4|Participant Flow|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390850|NCT01014091|P3|Participant Flow|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390851|NCT01014091|P2|Participant Flow|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390852|NCT01014091|P1|Participant Flow|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
391021|NCT01013792|B2|Baseline|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
404526|NCT00984308|O1|Outcome|Intervention|
390853|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390854|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390855|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390856|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390857|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390858|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390859|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390860|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390861|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390862|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390863|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390864|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390865|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390866|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390867|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390868|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390869|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390870|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390871|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390872|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390873|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390874|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390875|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
391022|NCT01013792|B1|Baseline|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
390876|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390877|NCT01014091|O3|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390878|NCT01014091|O2|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390879|NCT01014091|O1|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390880|NCT01014091|O3|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390881|NCT01014091|O2|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390882|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390883|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390884|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390885|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390886|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390887|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390888|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390889|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390890|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390891|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390892|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390893|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390894|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390895|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390896|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390897|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390898|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390899|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390900|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390901|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390902|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390903|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390904|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390905|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390906|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390907|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390908|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390909|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390910|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390911|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390912|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390913|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390914|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390915|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390916|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390917|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390918|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390919|NCT01014091|E6|Reported Event|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390920|NCT01014091|E5|Reported Event|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
390921|NCT01014091|E4|Reported Event|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390922|NCT01014091|E3|Reported Event|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
390923|NCT01014091|E2|Reported Event|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
404527|NCT00984308|O2|Outcome|Control|
390924|NCT01014091|E1|Reported Event|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
390925|NCT01014013|B3|Baseline|Total|Total of all reporting groups
390926|NCT01014013|B2|Baseline|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
390927|NCT01014013|B1|Baseline|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
390928|NCT01014013|P2|Participant Flow|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
390929|NCT01014013|P1|Participant Flow|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
390930|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
390931|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
390932|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
390933|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
390934|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
390935|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
390936|NCT01014013|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
390937|NCT01014013|E1|Reported Event|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
390938|NCT01013961|B3|Baseline|Total|Total of all reporting groups
390939|NCT01013961|B2|Baseline|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390940|NCT01013961|B1|Baseline|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390941|NCT01013961|P2|Participant Flow|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390942|NCT01013961|P1|Participant Flow|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
391023|NCT01013792|P2|Participant Flow|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
390943|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390944|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390945|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390946|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390947|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390948|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390949|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390950|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390951|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390952|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390953|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390980|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
391024|NCT01013792|P1|Participant Flow|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
404528|NCT00984308|O1|Outcome|Intervention|
390954|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390955|NCT01013961|E2|Reported Event|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390956|NCT01013961|E1|Reported Event|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
390957|NCT01013883|B3|Baseline|Total|Total of all reporting groups
390958|NCT01013883|B2|Baseline|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
390959|NCT01013883|B1|Baseline|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
390960|NCT01013883|P2|Participant Flow|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
390961|NCT01013883|P1|Participant Flow|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
390962|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
390963|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
390964|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
390965|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
390966|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
390967|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
390968|NCT01013883|E2|Reported Event|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
390969|NCT01013883|E1|Reported Event|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
390970|NCT01013870|B3|Baseline|Total|Total of all reporting groups
390971|NCT01013870|B2|Baseline|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390972|NCT01013870|B1|Baseline|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390973|NCT01013870|P2|Participant Flow|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390974|NCT01013870|P1|Participant Flow|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390975|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390976|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390977|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390978|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390979|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
391012|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
390981|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390982|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390983|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390984|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390985|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390986|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390987|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390988|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390989|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390990|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390991|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390992|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390993|NCT01013870|E2|Reported Event|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
390994|NCT01013870|E1|Reported Event|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
390995|NCT01013844|B3|Baseline|Total|Total of all reporting groups
390996|NCT01013844|B2|Baseline|Dyadic Learning|Participant and partner learning together.
390997|NCT01013844|B1|Baseline|Solo Learning|Participant learning alone (without partner).
390998|NCT01013844|P2|Participant Flow|Dyadic Learning|Participant and partner learning together.
390999|NCT01013844|P1|Participant Flow|Solo Learning|Participant learning alone (without partner).
391000|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
391001|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
391002|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
391003|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
391004|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
391005|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
391006|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
391007|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
391008|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
391009|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
391010|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
391011|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
391025|NCT01013792|O2|Outcome|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
391026|NCT01013792|O1|Outcome|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
391027|NCT01013792|E2|Reported Event|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
391028|NCT01013792|E1|Reported Event|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
391029|NCT01013753|B1|Baseline|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
391030|NCT01013753|P1|Participant Flow|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
391031|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391032|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391033|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391034|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391035|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391036|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391037|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391038|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391039|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391040|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391041|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391042|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391043|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391044|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391045|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391046|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391047|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391048|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391049|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391050|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391051|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391052|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391053|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391054|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391055|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391056|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391057|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391058|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391059|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391060|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391061|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391062|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391063|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391064|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391065|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391066|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391067|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391068|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391070|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391071|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391072|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391073|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391074|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391075|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391076|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391077|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391078|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391079|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391080|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391081|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391082|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391083|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391084|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391085|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391086|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391087|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391088|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391089|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391090|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391091|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391092|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391093|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391094|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391095|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391096|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391097|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391098|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391099|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391100|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391101|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391102|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391103|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391104|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391105|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391106|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391107|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391108|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391109|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391110|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391111|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391112|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391113|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391114|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391115|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391116|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391117|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391118|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391119|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391120|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391121|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391122|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391123|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391124|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391125|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391126|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391127|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391128|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391129|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391130|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391131|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391132|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391133|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391134|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391135|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391136|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391137|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391138|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391139|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391140|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391141|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391142|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391143|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391144|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391145|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391146|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391147|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391148|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391149|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391150|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391151|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391152|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391153|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391154|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391155|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391156|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391157|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391158|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391159|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391160|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391161|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391162|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391163|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391164|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391165|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391166|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391167|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391168|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391169|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
404529|NCT00984308|E2|Reported Event|Control|
391170|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391171|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391172|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391173|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391174|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391175|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391176|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391177|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391178|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391179|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391180|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391181|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391182|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391183|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391184|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391185|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391186|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391187|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391188|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391189|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391190|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391191|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391192|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391193|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391194|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391195|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391196|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391197|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391198|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391199|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391200|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391201|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391202|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391203|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391204|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391205|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391206|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391207|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391208|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391209|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391210|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391211|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391212|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391213|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391214|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391215|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391216|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391217|NCT01013753|E6|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
391218|NCT01013753|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391219|NCT01013753|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391220|NCT01013753|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391221|NCT01013753|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
391222|NCT01013753|E1|Reported Event|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
391223|NCT01013740|B3|Baseline|Total|Total of all reporting groups
391224|NCT01013740|B2|Baseline|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
391225|NCT01013740|B1|Baseline|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
391226|NCT01013740|P2|Participant Flow|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
391227|NCT01013740|P1|Participant Flow|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
391228|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391229|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391230|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391231|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391232|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391233|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391234|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391235|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391882|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391236|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391237|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391238|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391239|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391240|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391241|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391242|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391243|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391244|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
391245|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
391246|NCT01013740|E4|Reported Event|Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Crossover phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
391247|NCT01013740|E3|Reported Event|Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Crossover phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
391248|NCT01013740|E2|Reported Event|Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Randomized phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
391249|NCT01013740|E1|Reported Event|Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Randomized phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
391250|NCT01013701|B1|Baseline|All Participants|"nasal steroid fluticasone furoate: nasal steroid spray~OR~nasal spray vehicle without drug placebo: nasal steroid vehicle without drug"
391251|NCT01013701|P1|Participant Flow|All Participants|"nasal steroid fluticasone furoate: nasal steroid spray~OR~nasal spray vehicle without drug placebo: nasal steroid vehicle without drug"
391252|NCT01013701|O2|Outcome|Placebo|nasal spray vehicle without drug placebo: nasal steroid vehicle without drug
391253|NCT01013701|O1|Outcome|Nasal Steroid|nasal steroid fluticasone furoate: nasal steroid spray
391254|NCT01013701|O2|Outcome|Placebo|nasal spray vehicle without drug placebo: nasal steroid vehicle without drug
391255|NCT01013701|O1|Outcome|Nasal Steroid|nasal steroid fluticasone furoate: nasal steroid spray
391256|NCT01013701|E1|Reported Event|All Participants|"nasal steroid fluticasone furoate: nasal steroid spray~OR~nasal spray vehicle without drug placebo: nasal steroid vehicle without drug"
391257|NCT01013597|B1|Baseline|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391258|NCT01013597|P1|Participant Flow|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391259|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391260|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391261|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391262|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391263|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391264|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391265|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391266|NCT01013597|E1|Reported Event|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
391267|NCT01013207|B1|Baseline|All Participants|
391268|NCT01013207|P1|Participant Flow|All Participants|
391269|NCT01013207|O1|Outcome|All Participants|
391270|NCT01013207|O1|Outcome|All Participants|
391271|NCT01013207|E1|Reported Event|All Participants|
391272|NCT01013194|B3|Baseline|Total|Total of all reporting groups
391273|NCT01013194|B2|Baseline|Control Patients|Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation.
391274|NCT01013194|B1|Baseline|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells.
391275|NCT01013194|P2|Participant Flow|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
391276|NCT01013194|P1|Participant Flow|Treated Patients|"Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.~Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.~Cell infusion: between 5x10^8 and 10x10^8 cells. Number of sessions: up to 2."
391277|NCT01013194|O2|Outcome|Control Patients|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
391278|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells.
391279|NCT01013194|O2|Outcome|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
391280|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells
391281|NCT01013194|O2|Outcome|Control Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
391282|NCT01013194|O1|Outcome|Treated Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
391283|NCT01013194|E2|Reported Event|Control Group|Patients with end-stage chronic liver disease in waiting list for liver transplantation.
391284|NCT01013194|E1|Reported Event|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
391285|NCT01012999|B1|Baseline|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.~Intranasal administration, 0.5 mcg/kg to an extremity and in moderate to severe pain, one time dose."
391286|NCT01012999|P1|Participant Flow|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.~Intranasal administration, 0.5 mcg/kg, one time dose."
391287|NCT01012999|O1|Outcome|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
391288|NCT01012999|E1|Reported Event|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
391289|NCT01012973|B3|Baseline|Total|Total of all reporting groups
391290|NCT01012973|B2|Baseline|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391291|NCT01012973|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391292|NCT01012973|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391293|NCT01012973|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept Injection|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391294|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391295|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391296|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391297|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391298|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391299|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391300|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391301|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391302|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391303|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391304|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
391305|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
391306|NCT01012973|E6|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 68)|Participants on sham treatment switched to IAI, received a 2 mg dose of IAI at Week 52 and depending on the study retreatment criteria at Week 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
391307|NCT01012973|E5|Reported Event|Aflibercept Injection Continued (Until Week 68)|Participants on IAI who continued the study drug until Week 52, received 2 mg dose of IAI depending on the study retreatment criteria at Week 52, 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
391308|NCT01012973|E4|Reported Event|Sham Treatment (Until Week 48)|Participants who continued the study drug until Week 24 received sham treatment administered every 4 weeks from Week 24 to Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
391309|NCT01012973|E3|Reported Event|Aflibercept Injection (Until Week 48)|Participants who continued the study drug until Week 24 received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
391310|NCT01012973|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received sham treatment administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
391311|NCT01012973|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
391312|NCT01012947|B6|Baseline|Total|Total of all reporting groups
391313|NCT01012947|B5|Baseline|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
391314|NCT01012947|B4|Baseline|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
391315|NCT01012947|B3|Baseline|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
391316|NCT01012947|B2|Baseline|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
391317|NCT01012947|B1|Baseline|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
391318|NCT01012947|P5|Participant Flow|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
391319|NCT01012947|P4|Participant Flow|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
391320|NCT01012947|P3|Participant Flow|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
391520|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391883|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391321|NCT01012947|P2|Participant Flow|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
391322|NCT01012947|P1|Participant Flow|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
391323|NCT01012947|O5|Outcome|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
391324|NCT01012947|O4|Outcome|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
391325|NCT01012947|O3|Outcome|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
391326|NCT01012947|O2|Outcome|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
391327|NCT01012947|O1|Outcome|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
391328|NCT01012947|E5|Reported Event|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
391329|NCT01012947|E4|Reported Event|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
391330|NCT01012947|E3|Reported Event|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
391331|NCT01012947|E2|Reported Event|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
391332|NCT01012947|E1|Reported Event|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
391333|NCT01012921|B3|Baseline|Total|Total of all reporting groups
391334|NCT01012921|B2|Baseline|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
391335|NCT01012921|B1|Baseline|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
391336|NCT01012921|P2|Participant Flow|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
391337|NCT01012921|P1|Participant Flow|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
391338|NCT01012921|O2|Outcome|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
391339|NCT01012921|O1|Outcome|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
391340|NCT01012921|E2|Reported Event|MembraGel|"MembraGel The Straumann membrane is a synthetic degradable barrier membrane~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~MembraGel: Device application at surgery"
391341|NCT01012921|E1|Reported Event|Bio-Gide® Membrane|"Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin~barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).~Bio-Gide® membrane: Device application at surgery"
391342|NCT01012765|B1|Baseline|Safety Set|The safety set included all participants who received at least one dose of study medication during at least one study period.
391343|NCT01012765|P6|Participant Flow|Tiotropium - Indacaterol - Placebo|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391344|NCT01012765|P5|Participant Flow|Placebo - Tiotropium - Indacaterol|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391362|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391521|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391345|NCT01012765|P4|Participant Flow|Placebo - Indacaterol - Tiotropium|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391346|NCT01012765|P3|Participant Flow|Indacaterol - Tiotropium - Placebo|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391347|NCT01012765|P2|Participant Flow|Indacaterol - Placebo - Tiotropium|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391348|NCT01012765|P1|Participant Flow|Tiotropium - Placebo - Indacaterol|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391349|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391350|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391351|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391352|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391353|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391354|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391355|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391356|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391357|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391358|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391359|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391360|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391361|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391522|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
404530|NCT00984308|E1|Reported Event|Intervention|
391363|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391364|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391365|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391366|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391367|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391368|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391369|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391370|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391371|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391372|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391373|NCT01012765|E3|Reported Event|Tiotropium 18ug|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391374|NCT01012765|E2|Reported Event|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391375|NCT01012765|E1|Reported Event|Indacaterol 150ug|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
391376|NCT01012739|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg via the Concept1 dry-powder inhaler (DPI), indacaterol 60 µg via the Simoon DPI, indacaterol 120 µg via the Simoon DPI, and placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391377|NCT01012739|P4|Participant Flow|Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg|In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391378|NCT01012739|P3|Participant Flow|Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg|In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391392|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391379|NCT01012739|P2|Participant Flow|Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo|In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391380|NCT01012739|P1|Participant Flow|Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg|In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391381|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391382|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391383|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391384|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391385|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391386|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391387|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391388|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391389|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391390|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391391|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391523|NCT01012323|E1|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391393|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391394|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391395|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391396|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391397|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391398|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391399|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391400|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391401|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391402|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391403|NCT01012739|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391404|NCT01012739|E3|Reported Event|Indacaterol 120 μg|Patients received indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391405|NCT01012739|E2|Reported Event|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391406|NCT01012739|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI)only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
391471|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
391524|NCT01012297|B3|Baseline|Total|Total of all reporting groups
391407|NCT01012713|B1|Baseline|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
391408|NCT01012713|P1|Participant Flow|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in the Psoriasis Area and Severity Index thereafter."
391409|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than a 75% reduction in Psoriasis Area and Severity Index."
391410|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
391411|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
391412|NCT01012713|E1|Reported Event|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
391413|NCT01012674|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
391414|NCT01012674|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
391415|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
391416|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
391417|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
391418|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
391419|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
391420|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
391421|NCT01012674|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn from the study before Dotarem IV administration whatever the reason
391422|NCT01012674|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from CT angiography after the IV administration of an iodinated contrast medium
391423|NCT01012674|E2|Reported Event|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
391424|NCT01012674|E1|Reported Event|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
391425|NCT01012661|B1|Baseline|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
391426|NCT01012661|P1|Participant Flow|Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl). The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).
391427|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
391428|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
391429|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
391430|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
391431|NCT01012661|E2|Reported Event|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
391432|NCT01012661|E1|Reported Event|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
391433|NCT01012622|B1|Baseline|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391472|NCT01012388|E1|Reported Event|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
391473|NCT01012362|B6|Baseline|Total|Total of all reporting groups
404531|NCT00984295|B4|Baseline|Total|Total of all reporting groups
391434|NCT01012622|P1|Participant Flow|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391435|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391436|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391437|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391438|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391439|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391440|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391441|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391442|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391443|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391444|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391445|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391446|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391447|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391448|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391449|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391450|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391451|NCT01012622|E1|Reported Event|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
391452|NCT01012492|B1|Baseline|Abatacept|"Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.~Abatacept: Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept."
391453|NCT01012492|P1|Participant Flow|Abatacept|"Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.~Abatacept: Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept."
391454|NCT01012492|O1|Outcome|Abatacept|"Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.~Abatacept: Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept."
391455|NCT01012492|O1|Outcome|Abatacept|"Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.~Abatacept: Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept."
391456|NCT01012492|E1|Reported Event|Abatacept|"In this trial, we will test the safety and tolerability of the addition of the CD28-B7 blockade agent, abatacept, as an adjunctive therapy for the prevention of GvHD in a high-risk BMT cohort. Four doses of abatacept will be given according to a dosing schedule based on previous trials using CD28-B7 blockade with belatacept in kidney transplantation. Pharmacokinetic and pharmakodynamic analysis of abatacept will be undertaken, as well as an evaluation of the incidence and severity of acute GvHD in this patient cohort.~Dosage: Abatacept is administered as an intravenous infusion under medically controlled conditions. Dose is 10mg/kg with a maximum dose of 1 gram. Abatacept should be administered as a 30-minute intravenous infusion. In this study, abatacept will be dosed on days -1, +5, +14, +28 post-transplant. Small adjustments in dose to accommodate abatacept vial size may be acceptable. These dose adjustments must be approved by the study PI."
391457|NCT01012440|B1|Baseline|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
391458|NCT01012440|P1|Participant Flow|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
391459|NCT01012440|O1|Outcome|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
391460|NCT01012440|E1|Reported Event|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
391461|NCT01012414|B1|Baseline|Enrolled|Total number participants consentedand enrolled
391462|NCT01012414|P1|Participant Flow|All Participants|The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.
391463|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
391464|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
391465|NCT01012414|O1|Outcome|Alll Participants|no arm /group title is provided as there was no enrollment.
391466|NCT01012414|O1|Outcome|All Participants|no arm /group title is provided as there was no enrollment.
391467|NCT01012414|E1|Reported Event|All Participants|All participants in the study.
391468|NCT01012388|B1|Baseline|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
391469|NCT01012388|P1|Participant Flow|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
391470|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
404828|NCT00983918|O4|Outcome|Propofol|General Anesthesia with Propofol
391474|NCT01012362|B5|Baseline|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
391475|NCT01012362|B4|Baseline|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
391476|NCT01012362|B3|Baseline|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
391477|NCT01012362|B2|Baseline|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
391478|NCT01012362|B1|Baseline|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
391479|NCT01012362|P5|Participant Flow|Arm 2|Pazopanib 600mg - Ixabepilone 32 mg/m2. This is an additional cohort of head and neck cancer patients treated at the optimal tolerated regimen for the purpose of performing pharmacokinetics, confirm safety information and obtainadditional preliminary efficacy data in this patient population.
391480|NCT01012362|P4|Participant Flow|Arm 1: Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
391481|NCT01012362|P3|Participant Flow|Arm 1: Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
391482|NCT01012362|P2|Participant Flow|Arm 1: Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
391483|NCT01012362|P1|Participant Flow|Arm 1: Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
391484|NCT01012362|O4|Outcome|Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
391485|NCT01012362|O3|Outcome|Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2
391486|NCT01012362|O2|Outcome|Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
391487|NCT01012362|O1|Outcome|Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
391488|NCT01012362|O5|Outcome|Arm 2: Dose Level 3|6400 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
391489|NCT01012362|O4|Outcome|Arm 1: Dose Level 4|800 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
391490|NCT01012362|O3|Outcome|Arm 1: Dose Level 3|600 milligrams (mg) of Pazopanib and Ixabepilone 32 mg/m2
391491|NCT01012362|O2|Outcome|Arm 1: Dose Level 2|400 milligrams (mg) of Pazopanib and Ixabepilone 40 mg/m2
391492|NCT01012362|O1|Outcome|Arm 1: Dose Level 1|400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.
391493|NCT01012362|O1|Outcome|All Arm 1 Participants|All participants who received at least one cycle of one of the following 4 dose levels: Dose Level 1: Pazopanib 400mg - Ixabepilone 32mg/m2; Dose Level 2: Pazopanib 400mg - Ixabepilone 40mg/m2; Dose Level 3: Pazopanib 600mg - Ixabepilone 32 mg/m2; or Dose Level 4: Pazopanib 800mg - Ixabepilone 32 mg//m2.
391494|NCT01012362|E4|Reported Event|Dose Level 4|Pazopanib 800mg - Ixabepilone 32 mg//m2
391495|NCT01012362|E3|Reported Event|Dose Level 3|Pazopanib 600mg - Ixabepilone 32 mg/m2 Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.
391496|NCT01012362|E2|Reported Event|Dose Level 2|Pazopanib 400mg - Ixabepilone 40mg/m2
391497|NCT01012362|E1|Reported Event|Dose Level 1|Pazopanib 400mg - Ixabepilone 32mg/m2
391498|NCT01012336|B1|Baseline|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
391499|NCT01012336|P1|Participant Flow|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
391500|NCT01012336|O1|Outcome|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
391501|NCT01012336|E1|Reported Event|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
391502|NCT01012323|B1|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391503|NCT01012323|P1|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391504|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391505|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391506|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391507|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391508|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391509|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391510|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391511|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391512|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391513|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391514|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391515|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391516|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391517|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391518|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
391519|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
407473|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
391525|NCT01012297|B2|Baseline|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
391526|NCT01012297|B1|Baseline|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
391527|NCT01012297|P2|Participant Flow|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
391528|NCT01012297|P1|Participant Flow|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
391529|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
391530|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
391531|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
391532|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
391533|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
391534|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
391535|NCT01012297|O2|Outcome|Arm II Gem+Doce+Bev|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
391536|NCT01012297|O1|Outcome|Arm I Gem+Doce+Placebo|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
391537|NCT01012297|E2|Reported Event|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC"
391538|NCT01012297|E1|Reported Event|Arm I|"Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV"
391539|NCT01012258|B1|Baseline|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
391540|NCT01012258|P1|Participant Flow|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
391877|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391541|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
391542|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
391543|NCT01012258|E2|Reported Event|Cetuximab: Late Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Late phase, i.e. adverse events which occur or worsen more than 60 days after the last trial treatment administration (cetuximab or radiotherapy), and before end of trial.
391544|NCT01012258|E1|Reported Event|Cetuximab: Treatment Emergent Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Treatment emergent phase, i.e. treatment-emergent adverse events (TEAEs, adverse events which occur or worsen on the first dosing day of trial treatment and until 60 days after the last trial treatment administration (cetuximab or radiotherapy).
391545|NCT01012245|B5|Baseline|Total|Total of all reporting groups
391546|NCT01012245|B4|Baseline|Other Medication|Subjects with other or no hypotensive therapy at baseline visit
391547|NCT01012245|B3|Baseline|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
391548|NCT01012245|B2|Baseline|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit
391549|NCT01012245|B1|Baseline|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391550|NCT01012245|P1|Participant Flow|Subjects With Glaucoma and Ocular Hypertension|All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit.
391551|NCT01012245|O2|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
391552|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391553|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
391554|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391555|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
391556|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
391557|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
391558|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
391559|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
391560|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
391561|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391562|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
391563|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391564|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391565|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
391566|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
391567|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
391568|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391569|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
391570|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
391571|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
391572|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
391573|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391574|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
391575|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
391576|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
391577|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
391578|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391579|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
391580|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
391581|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
391582|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
391583|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
391584|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
391585|NCT01012245|E1|Reported Event|All Subjects|Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit.
391586|NCT01012219|B1|Baseline|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
391587|NCT01012219|P1|Participant Flow|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
391588|NCT01012219|O2|Outcome|Clopidogrel + Aspirin|Participants from Periods 1 and 2
391589|NCT01012219|O1|Outcome|Clopidogrel + Aspirin +Laropiprant|Participants from Periods 1 and 2
391590|NCT01012219|E3|Reported Event|Laropiprant + Niacin|Participants from Period 3
391591|NCT01012219|E2|Reported Event|Clopidogrel + Aspirin|Participants from Periods 1 and 2
391592|NCT01012219|E1|Reported Event|Laropiprant + Clopidrogel + Aspirin|Participants from Periods 1 and 2
391593|NCT01012167|B4|Baseline|Total|Total of all reporting groups
391594|NCT01012167|B3|Baseline|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
391595|NCT01012167|B2|Baseline|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
391596|NCT01012167|B1|Baseline|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
391597|NCT01012167|P3|Participant Flow|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391598|NCT01012167|P2|Participant Flow|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391599|NCT01012167|P1|Participant Flow|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391600|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391601|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391602|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391603|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391604|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391605|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391606|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391607|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391608|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391609|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391610|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391611|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391612|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391613|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391614|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391615|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391616|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391617|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391618|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391619|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391878|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391620|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391621|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391622|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391623|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391624|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391625|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391626|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391627|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391628|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391629|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391630|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391631|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391632|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391633|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391634|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391635|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391636|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391637|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391638|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391639|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391640|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391641|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391642|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391643|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391644|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391645|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391646|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391647|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391648|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391649|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391650|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391651|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391652|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391653|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391654|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391655|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391656|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391657|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391658|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391659|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391660|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391661|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391662|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391663|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391664|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391665|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391666|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391667|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391668|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391669|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391670|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391671|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
408538|NCT00975637|B3|Baseline|Broda 280 mg|AMG 827: 280 mg SC
391672|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391673|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391674|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391675|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391676|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391677|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391678|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391679|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391680|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391681|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391682|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391683|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391684|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391685|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391686|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391687|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391688|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391689|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391690|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391691|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391692|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391693|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391694|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391695|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391696|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391697|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391698|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391699|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391700|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391701|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391702|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391703|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391704|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391705|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391706|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391707|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391708|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391709|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391710|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391711|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391712|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391713|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391714|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391715|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391716|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391717|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391718|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391719|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391720|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391721|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391722|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391723|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391724|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391725|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391726|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391727|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391728|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391729|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391730|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391731|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391732|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391733|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391734|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391735|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391736|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391737|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391738|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391739|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391740|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391741|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391742|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391743|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391744|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391745|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391746|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391747|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391748|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391749|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391750|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391751|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391752|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391753|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391754|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391755|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391756|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391757|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391758|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391759|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391760|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391761|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391762|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391763|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391764|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391765|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391766|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391767|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391768|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391769|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391770|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391771|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391772|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391773|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391774|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391775|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391776|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391777|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391778|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391779|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391780|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391781|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391782|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391783|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391784|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391785|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391786|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391787|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391788|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391789|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.
391790|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391791|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391792|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391793|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391794|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391795|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391796|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391797|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391798|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391799|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391800|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391801|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391802|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391803|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391804|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391805|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391806|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391807|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391808|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391809|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391810|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391811|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391812|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391813|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391814|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391815|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391816|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391817|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391818|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391819|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391820|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391821|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391822|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391823|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391824|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391825|NCT01012167|O3|Outcome|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
391826|NCT01012167|O2|Outcome|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
391827|NCT01012167|O1|Outcome|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
391828|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391829|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391830|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391831|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391832|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391833|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391834|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391835|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391836|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391837|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391838|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391839|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391840|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391841|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391842|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391843|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391844|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391845|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391846|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
391847|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
391848|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
391849|NCT01012167|E3|Reported Event|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
391850|NCT01012167|E2|Reported Event|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
391851|NCT01012167|E1|Reported Event|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
391852|NCT01012037|B4|Baseline|Total|Total of all reporting groups
391853|NCT01012037|B3|Baseline|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391854|NCT01012037|B2|Baseline|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391855|NCT01012037|B1|Baseline|Placebo|Patients treated with matching placebo
391856|NCT01012037|P3|Participant Flow|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391857|NCT01012037|P2|Participant Flow|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391858|NCT01012037|P1|Participant Flow|Placebo|Patients treated with matching placebo
391859|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391860|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391861|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391862|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391863|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391864|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391865|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391866|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391867|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391868|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391869|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391870|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391871|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391872|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391873|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391874|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391875|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391876|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391884|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391885|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391886|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391887|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391888|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
391889|NCT01012037|E3|Reported Event|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
391890|NCT01012037|E2|Reported Event|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
391891|NCT01012037|E1|Reported Event|Placebo|Patients treated with matching placebo
391892|NCT01011946|B1|Baseline|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
391893|NCT01011946|P1|Participant Flow|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
391894|NCT01011946|O1|Outcome|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
391895|NCT01011946|E1|Reported Event|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
391896|NCT01011933|B1|Baseline|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391897|NCT01011933|P1|Participant Flow|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391898|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391899|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391900|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391901|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391902|NCT01011933|O6|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
391903|NCT01011933|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
391904|NCT01011933|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
391905|NCT01011933|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
391906|NCT01011933|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
391907|NCT01011933|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
391908|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391909|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391910|NCT01011933|E1|Reported Event|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
391911|NCT01011907|B3|Baseline|Total|Total of all reporting groups
391912|NCT01011907|B2|Baseline|Varenicline|
391913|NCT01011907|B1|Baseline|Placebo|
391914|NCT01011907|P2|Participant Flow|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
391915|NCT01011907|P1|Participant Flow|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
391916|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
392217|NCT01011335|O4|Outcome|Placebo Doses|Alum placebo and Saline placebo
391917|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
391918|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
391919|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
391920|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
391921|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
391922|NCT01011907|E2|Reported Event|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
391923|NCT01011907|E1|Reported Event|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
391924|NCT01011894|B1|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
391925|NCT01011894|P1|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
391926|NCT01011894|O1|Outcome|Participants Receiving Lenalidomide|Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.
391927|NCT01011894|E1|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
391928|NCT01011868|B4|Baseline|Total|Total of all reporting groups
391929|NCT01011868|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391930|NCT01011868|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391931|NCT01011868|B1|Baseline|Placebo|Oral Placebo
391932|NCT01011868|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391933|NCT01011868|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391934|NCT01011868|P1|Participant Flow|Placebo|Oral Placebo
391935|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391936|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391937|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391938|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391939|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391940|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391941|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391942|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391943|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391944|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391945|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391946|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391947|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391948|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391949|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391950|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391951|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391952|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391953|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391954|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391955|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391956|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391957|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391958|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391959|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391960|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391961|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391962|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391963|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391964|NCT01011868|O1|Outcome|Placebo|Oral Placebo
391965|NCT01011868|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
391966|NCT01011868|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
391967|NCT01011868|E1|Reported Event|Placebo|Oral Placebo
391968|NCT01011829|B3|Baseline|Total|Total of all reporting groups
391969|NCT01011829|B2|Baseline|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
391970|NCT01011829|B1|Baseline|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
391971|NCT01011829|P2|Participant Flow|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
391972|NCT01011829|P1|Participant Flow|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
391973|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
391974|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
391975|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
391976|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
391977|NCT01011829|E2|Reported Event|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
391978|NCT01011829|E1|Reported Event|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
391979|NCT01011816|B3|Baseline|Total|Total of all reporting groups
391980|NCT01011816|B2|Baseline|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
391981|NCT01011816|B1|Baseline|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
391982|NCT01011816|P2|Participant Flow|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
391983|NCT01011816|P1|Participant Flow|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
391984|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
391985|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
391986|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
391987|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
391988|NCT01011816|O2|Outcome|Saline|"One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc~Saline: One injection of up to 4 mL of saline using the Biostat Delivery Device"
391989|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|"One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc~BIOSTAT BIOLOGX: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device"
391990|NCT01011816|E2|Reported Event|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
391991|NCT01011816|E1|Reported Event|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
391992|NCT01011738|B4|Baseline|Total|Total of all reporting groups
391993|NCT01011738|B3|Baseline|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
391994|NCT01011738|B2|Baseline|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
391995|NCT01011738|B1|Baseline|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
391996|NCT01011738|P3|Participant Flow|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
391997|NCT01011738|P2|Participant Flow|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
391998|NCT01011738|P1|Participant Flow|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
391999|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
392000|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392080|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392001|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392002|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
392003|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392004|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392005|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
392006|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392007|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392008|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
392009|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392010|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392011|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392012|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392013|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392014|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392015|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392016|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392081|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392082|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392218|NCT01011335|O3|Outcome|Bivalent rAT/rLukS Doses|rAT/rLukS 10µg, 25µg, 50µg
392017|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392018|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392019|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392020|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392021|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392022|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392023|NCT01011738|O1|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392024|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392025|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392026|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392027|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392028|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392029|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392030|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392031|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392032|NCT01011738|E3|Reported Event|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
392033|NCT01011738|E2|Reported Event|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
392034|NCT01011738|E1|Reported Event|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
392035|NCT01011673|B3|Baseline|Total|Total of all reporting groups
392036|NCT01011673|B2|Baseline|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
392037|NCT01011673|B1|Baseline|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
392038|NCT01011673|P2|Participant Flow|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
392039|NCT01011673|P1|Participant Flow|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
392040|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
392041|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
392042|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
392043|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
392044|NCT01011673|E2|Reported Event|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
392045|NCT01011673|E1|Reported Event|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
392046|NCT01011634|B3|Baseline|Total|Total of all reporting groups
392047|NCT01011634|B2|Baseline|Oral Medication|
392048|NCT01011634|B1|Baseline|Moderate Sedation|
392049|NCT01011634|P2|Participant Flow|Oral Medication|
392050|NCT01011634|P1|Participant Flow|Moderate Sedation|
392051|NCT01011634|O2|Outcome|Oral Medication|
392052|NCT01011634|O1|Outcome|Moderate Sedation|
392053|NCT01011634|O2|Outcome|Oral Medication|
392054|NCT01011634|O1|Outcome|Moderate Sedation|
392055|NCT01011634|E2|Reported Event|IV Medications|
392056|NCT01011634|E1|Reported Event|Oral Medications|
392057|NCT01011556|B5|Baseline|Total|Total of all reporting groups
392058|NCT01011556|B4|Baseline|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392059|NCT01011556|B3|Baseline|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392060|NCT01011556|B2|Baseline|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392061|NCT01011556|B1|Baseline|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392062|NCT01011556|P4|Participant Flow|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392063|NCT01011556|P3|Participant Flow|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392064|NCT01011556|P2|Participant Flow|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392065|NCT01011556|P1|Participant Flow|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392066|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392067|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392068|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392069|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392070|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392071|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392072|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392073|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392074|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392075|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392076|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392077|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392078|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392079|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392083|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392084|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392085|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392086|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392087|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392088|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392089|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 mcg teriparatide subcutaneously once daily in an unblinded manner.
392090|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392091|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392092|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392093|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392094|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392095|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392096|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392097|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392098|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392099|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392100|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392101|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392102|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392103|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392104|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392105|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392106|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392107|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392108|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392109|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
392110|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392111|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392112|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level
392113|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
392114|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392115|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392116|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392117|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
392118|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392119|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392120|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392121|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392122|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392219|NCT01011335|O2|Outcome|Monovalent rLukS Doses|Monovalent rLukS 10µg, 25µg, 50µg, 100µg
392123|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392124|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392125|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392126|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392127|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392128|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392129|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
392130|NCT01011556|E4|Reported Event|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392131|NCT01011556|E3|Reported Event|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392132|NCT01011556|E2|Reported Event|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
392133|NCT01011556|E1|Reported Event|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
392134|NCT01011465|B9|Baseline|Total|Total of all reporting groups
392135|NCT01011465|B8|Baseline|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392136|NCT01011465|B7|Baseline|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392137|NCT01011465|B6|Baseline|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392138|NCT01011465|B5|Baseline|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392139|NCT01011465|B4|Baseline|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392140|NCT01011465|B3|Baseline|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392150|NCT01011465|P1|Participant Flow|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392141|NCT01011465|B2|Baseline|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392142|NCT01011465|B1|Baseline|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392143|NCT01011465|P8|Participant Flow|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392144|NCT01011465|P7|Participant Flow|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392145|NCT01011465|P6|Participant Flow|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392146|NCT01011465|P5|Participant Flow|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392147|NCT01011465|P4|Participant Flow|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392148|NCT01011465|P3|Participant Flow|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392149|NCT01011465|P2|Participant Flow|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392197|NCT01011335|P2|Participant Flow|Monovalent rAT 25 ug Dose|Intramuscular; Monovalent rAT : 25 μg; single timepoint
392198|NCT01011335|P1|Participant Flow|Monovalent rAT 10 ug Dose|Intramuscular; Monovalent rAT : 10 μg; single timepoint
392151|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
392152|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
392153|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
392154|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
392155|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
392156|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
392157|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
392158|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
392159|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
392160|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
392161|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
392162|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
392163|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
392164|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
392165|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
392166|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
392167|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
392168|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
392169|NCT01011465|E8|Reported Event|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392170|NCT01011465|E7|Reported Event|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392199|NCT01011335|O18|Outcome|Normal Saline Placebo (for rLukS)|
392200|NCT01011335|O17|Outcome|Alum Placebo (for rLukS)|
392201|NCT01011335|O16|Outcome|rAT/rLukS 50 µg (for rLukS)|
392202|NCT01011335|O15|Outcome|rAT/rLukS 25 µg (for rLukS)|
392203|NCT01011335|O14|Outcome|rAT/rLukS 10 µg (for rLukS)|
392204|NCT01011335|O13|Outcome|rLukS 100 µg|
392205|NCT01011335|O12|Outcome|rLukS 50 µg|
392171|NCT01011465|E6|Reported Event|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392172|NCT01011465|E5|Reported Event|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392173|NCT01011465|E4|Reported Event|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392174|NCT01011465|E3|Reported Event|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392175|NCT01011465|E2|Reported Event|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
392176|NCT01011465|E1|Reported Event|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
392177|NCT01011387|B1|Baseline|NPWT System|Negative Pressure Wound Therapy
392178|NCT01011387|P1|Participant Flow|Negative Pressure Wound Therapy System|The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT.
392179|NCT01011387|O1|Outcome|NPWT System|Negative Pressure Wound Therapy
392180|NCT01011387|E1|Reported Event|NPWT System|Negative Pressure Wound Therapy
392181|NCT01011335|B5|Baseline|Total|Total of all reporting groups
392182|NCT01011335|B4|Baseline|Placebo Doses|Saline placebo or alum placebo
392183|NCT01011335|B3|Baseline|Bivalent rAT/rLukS-PV Doses|Bivalent rLukS-PV / rAT : 10, 25 or 50 μg
392184|NCT01011335|B2|Baseline|Monovalent rLukS-PV Doses|Monovalent rLukS-PV : 10, 25, 50 or 100 μg
392185|NCT01011335|B1|Baseline|Monovalent rAT Doses|Monovalent rAT : 10, 25, 50 or 100 μg
392186|NCT01011335|P13|Participant Flow|Normal Saline Placebo|Intramuscular; Saline Placebo : 10, 25, 50, 100 μg; single timepoint
392187|NCT01011335|P12|Participant Flow|Alum Placebo|Intramuscular; Alum placebo : 10, 25, 50, 100 μg; single timepoint
392188|NCT01011335|P11|Participant Flow|Bivalent rAT/rLukS 50 ug Dose|Intramuscular; Bivalent rAT/rLukS : 50 μg; single timepoint
392189|NCT01011335|P10|Participant Flow|Bivalent rAT/rLukS 25 ug Dose|Intramuscular; Bivalent rAT/rLukS : 25 μg; single timepoint
392190|NCT01011335|P9|Participant Flow|Bivalent rAT/rLukS 10 ug Dose|Intramuscular; Bivalent rAT/rLukS : 10 μg; single timepoint
392191|NCT01011335|P8|Participant Flow|Monovalent rLukS 100 ug Dose|Intramuscular; Monovalent rLukS-PV : 100 μg; single timepoint
392192|NCT01011335|P7|Participant Flow|Monovalent rLukS 50 ug Dose|Intramuscular; Monovalent rLukS-PV : 50 μg; single timepoint
392193|NCT01011335|P6|Participant Flow|Monovalent rLukS 25 ug Dose|Intramuscular; Monovalent rLukS-PV : 25 μg; single timepoint
392194|NCT01011335|P5|Participant Flow|Monovalent rLukS 10 ug Dose|Intramuscular; Monovalent rLukS-PV : 10 μg; single timepoint
392195|NCT01011335|P4|Participant Flow|Monovalent rAT 100 ug Dose|Intramuscular; Monovalent rAT : 100 μg; single timepoint
392196|NCT01011335|P3|Participant Flow|Monovalent rAT 50 ug Dose|Intramuscular; Monovalent rAT : 50 μg; single timepoint
392220|NCT01011335|O1|Outcome|Monovalent rAT Doses|Monovalent rAT 10µg, 25µg, 50µg, 100µg
392221|NCT01011335|E13|Reported Event|Normal Saline Placebo|
392222|NCT01011335|E12|Reported Event|Alum Placebo|
392223|NCT01011335|E11|Reported Event|Bivalent rAT/rLukS 50µg Dose|
392224|NCT01011335|E10|Reported Event|Bivalent rAT/rLukS 25µg Dose|
392225|NCT01011335|E9|Reported Event|Bivalent rAT/rLukS 10µg Dose|
392226|NCT01011335|E8|Reported Event|Monovalent rLukS 100µg Dose|
392227|NCT01011335|E7|Reported Event|Monovalent rLukS 50µg Dose|
392228|NCT01011335|E6|Reported Event|Monovalent rLukS 25µg Dose|
392229|NCT01011335|E5|Reported Event|Monovalent rLukS 10µg Dose|
392230|NCT01011335|E4|Reported Event|Monovalent rAT 100µg Dose|
392231|NCT01011335|E3|Reported Event|Monovalent rAT 50µg Dose|
392232|NCT01011335|E2|Reported Event|Monovalent rAT 25µg Dose|
392233|NCT01011335|E1|Reported Event|Monovalent rAT 10µg Dose|
392234|NCT01011309|B4|Baseline|Total|Total of all reporting groups
392235|NCT01011309|B3|Baseline|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
392236|NCT01011309|B2|Baseline|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
392237|NCT01011309|B1|Baseline|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
392238|NCT01011309|P3|Participant Flow|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
392239|NCT01011309|P2|Participant Flow|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
392240|NCT01011309|P1|Participant Flow|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
392241|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
392242|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
392243|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
392244|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
392245|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
392246|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
392247|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
392248|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
392249|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
392250|NCT01011309|E3|Reported Event|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
392251|NCT01011309|E2|Reported Event|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
392252|NCT01011309|E1|Reported Event|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
392253|NCT01011283|B3|Baseline|Total|Total of all reporting groups
392254|NCT01011283|B2|Baseline|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
392255|NCT01011283|B1|Baseline|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
392256|NCT01011283|P2|Participant Flow|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
392257|NCT01011283|P1|Participant Flow|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
392258|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
392259|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
392260|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
392261|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
392262|NCT01011283|E2|Reported Event|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
392263|NCT01011283|E1|Reported Event|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
392264|NCT01011179|B3|Baseline|Total|Total of all reporting groups
392265|NCT01011179|B2|Baseline|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
392266|NCT01011179|B1|Baseline|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
392267|NCT01011179|P2|Participant Flow|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
392268|NCT01011179|P1|Participant Flow|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
392269|NCT01011179|O2|Outcome|Attention Control Group|"Self-Management: Adolescents' own best efforts at managing their JIA"
392270|NCT01011179|O1|Outcome|Internet-based JIA Self-Management Program|Teens Taking Charge: The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
392271|NCT01011179|E2|Reported Event|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
392272|NCT01011179|E1|Reported Event|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
392273|NCT01011153|B4|Baseline|Total|Total of all reporting groups
392274|NCT01011153|B3|Baseline|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
392275|NCT01011153|B2|Baseline|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
392276|NCT01011153|B1|Baseline|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
392277|NCT01011153|P3|Participant Flow|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
392278|NCT01011153|P2|Participant Flow|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
392279|NCT01011153|P1|Participant Flow|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
392280|NCT01011153|O3|Outcome|Primary Care Physicians|
392281|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|
392282|NCT01011153|O1|Outcome|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
392283|NCT01011153|O4|Outcome|All Partipants|All Participants are the General Dermatologists, Pigmented Skin Lesion Experts and Primary Care Physicians combined.
392284|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
392285|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
392286|NCT01011153|O1|Outcome|Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
392287|NCT01011153|O4|Outcome|MelaFind|MelaFind imaged the 130 cases, the 65 positive cases (i.e., histologically confirmed melanoma) and the 65 negative cases (i.e., histologically confirmed non-melanoma). Sensitivity was calculated based on the correct identification of the 65 positive cases and specificity was calculated based on the correct identification of the 65 negative cases.
392288|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
392289|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
392290|NCT01011153|O1|Outcome|General Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
392291|NCT01011153|O2|Outcome|MelaFind|MelaFind imaged 130 cases which consisted of 65 positive cases (i.e., histolgoically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
392292|NCT01011153|O1|Outcome|Dermatologists|Dermatologists were defined as board-certified dermatologists who were General Dermatologists and Pigmented Skin Lesion Experts, according to the Intake Survey. Dermatologists in this group did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consistinf of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
392293|NCT01011153|E3|Reported Event|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
392393|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392294|NCT01011153|E2|Reported Event|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
392295|NCT01011153|E1|Reported Event|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
392296|NCT01011075|B1|Baseline|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
392297|NCT01011075|P1|Participant Flow|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
392298|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
392299|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
392300|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
392301|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
392302|NCT01011075|E1|Reported Event|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
392303|NCT01011049|B5|Baseline|Total|Total of all reporting groups
392304|NCT01011049|B4|Baseline|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
392305|NCT01011049|B3|Baseline|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
392306|NCT01011049|B2|Baseline|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
392307|NCT01011049|B1|Baseline|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
392308|NCT01011049|P4|Participant Flow|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
392309|NCT01011049|P3|Participant Flow|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
392310|NCT01011049|P2|Participant Flow|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
392311|NCT01011049|P1|Participant Flow|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
392312|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
392313|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
392314|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
392315|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
392316|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
392317|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
392318|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
392319|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
392320|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
392321|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
392322|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
392323|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
392324|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
408539|NCT00975637|B2|Baseline|Broda 140 mg|AMG 827: 140 mg SC
392325|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
392326|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
392327|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
392328|NCT01011049|E4|Reported Event|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
392329|NCT01011049|E3|Reported Event|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
392330|NCT01011049|E2|Reported Event|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
392331|NCT01011049|E1|Reported Event|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
392332|NCT01010971|B4|Baseline|Total|Total of all reporting groups
392333|NCT01010971|B3|Baseline|Placebo|Placebo once daily
392334|NCT01010971|B2|Baseline|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392335|NCT01010971|B1|Baseline|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392336|NCT01010971|P3|Participant Flow|Placebo|Placebo once daily
392337|NCT01010971|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392338|NCT01010971|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392339|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392340|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392341|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392342|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392343|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392344|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392345|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392346|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392347|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392348|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392349|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392350|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392351|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392352|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392353|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392354|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392355|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392356|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392357|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392358|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392359|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392360|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392361|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392362|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392363|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392364|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392365|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392366|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392367|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392368|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392369|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392370|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392371|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392372|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392373|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392374|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392375|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392376|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392377|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392378|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392379|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392380|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392381|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392382|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392383|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392384|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392385|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392386|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392387|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392388|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392389|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392390|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392391|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392392|NCT01010971|O3|Outcome|Placebo|Placebo once daily
408540|NCT00975637|B1|Baseline|Broda 210 mg|AMG 827: 210 mg SC
392394|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392395|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392396|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392397|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392398|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392399|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392400|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392401|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392402|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392403|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392404|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392405|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392406|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392407|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392408|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392409|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392410|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392411|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392412|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392413|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392414|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392415|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392416|NCT01010971|O3|Outcome|Placebo|Placebo once daily
392417|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392418|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392419|NCT01010971|E3|Reported Event|Placebo|Placebo once daily
392420|NCT01010971|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
392421|NCT01010971|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
392422|NCT01010932|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
392423|NCT01010932|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
392424|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
392425|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
392426|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
392427|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
392428|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
392429|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
392430|NCT01010932|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn before administration of Dotarem whatever the reason
392431|NCT01010932|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium
392432|NCT01010932|E2|Reported Event|TOF MRA|Patients benefiting from a MR angiography with no contrast medium administration
392433|NCT01010932|E1|Reported Event|Dotarem MRA|Patients benefiting from a MR angiography after an IV administration of Dotarem
392434|NCT01010906|B7|Baseline|Total|Total of all reporting groups
392435|NCT01010906|B6|Baseline|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
392436|NCT01010906|B5|Baseline|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
392437|NCT01010906|B4|Baseline|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392438|NCT01010906|B3|Baseline|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
392439|NCT01010906|B2|Baseline|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392440|NCT01010906|B1|Baseline|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
392441|NCT01010906|P6|Participant Flow|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
392442|NCT01010906|P5|Participant Flow|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
392443|NCT01010906|P4|Participant Flow|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392444|NCT01010906|P3|Participant Flow|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
392445|NCT01010906|P2|Participant Flow|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392446|NCT01010906|P1|Participant Flow|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
392447|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
392448|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
392449|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392450|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
392451|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392452|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
392453|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
392454|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
392455|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392456|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
392457|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392458|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
392459|NCT01010906|E6|Reported Event|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
392460|NCT01010906|E5|Reported Event|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
392461|NCT01010906|E4|Reported Event|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392462|NCT01010906|E3|Reported Event|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
392463|NCT01010906|E2|Reported Event|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
392464|NCT01010906|E1|Reported Event|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
392465|NCT01010867|B1|Baseline|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
392466|NCT01010867|P1|Participant Flow|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.~Colony forming units (CFU)"
392467|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
392468|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
392469|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
392470|NCT01010867|O1|Outcome|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
392471|NCT01010867|E1|Reported Event|Lactobacillus Plantarum|"There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.~Lactobacillus plantarum strains 299 and 299v: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C."
392472|NCT01010854|B1|Baseline|VPA FEC100|"Valproic Acid with FEC100~VPA FEC100: oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
392473|NCT01010854|P1|Participant Flow|VPA FEC100|"Valproic Acid with FEC100~oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
392474|NCT01010854|O1|Outcome|VPA FEC100|"Valproic Acid with FEC100~oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
392475|NCT01010854|O1|Outcome|VPA FEC100|"Valproic Acid with FEC100~oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
392476|NCT01010854|E1|Reported Event|VPA FEC100|"Valproic Acid with FEC100~oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)"
392477|NCT01010776|B1|Baseline|Paliperidone ER - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392505|NCT01010750|B1|Baseline|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|
392616|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392478|NCT01010776|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392479|NCT01010776|O1|Outcome|Paliperidone ER-Main Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392480|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Single oral dose of paliperidone ER tablet within the range of 3 to 12 mg once a day was administered for 26 weeks. Dosage was adjusted as per the investigator’s discretion.
392481|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392482|NCT01010776|O1|Outcome|Paliperidone ER- Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392483|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392484|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392485|NCT01010776|O1|Outcome|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally, once daily for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392486|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392487|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392488|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392489|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392490|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392491|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392492|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392493|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392494|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392495|NCT01010776|O1|Outcome|Paliperidone (ER) - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392496|NCT01010776|O1|Outcome|Paliperidone Extended Release (ER) - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392497|NCT01010776|E2|Reported Event|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
392498|NCT01010776|E1|Reported Event|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
392499|NCT01010750|B7|Baseline|Total|Total of all reporting groups
392500|NCT01010750|B6|Baseline|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|
392501|NCT01010750|B5|Baseline|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|
392502|NCT01010750|B4|Baseline|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|
392503|NCT01010750|B3|Baseline|Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg|
392504|NCT01010750|B2|Baseline|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|
392506|NCT01010750|P6|Participant Flow|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
392507|NCT01010750|P5|Participant Flow|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
392508|NCT01010750|P4|Participant Flow|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
392509|NCT01010750|P3|Participant Flow|Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg|LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
392510|NCT01010750|P2|Participant Flow|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
392511|NCT01010750|P1|Participant Flow|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
392512|NCT01010750|O3|Outcome|Placebo|
392513|NCT01010750|O2|Outcome|MAS-IR 20 mg|
392514|NCT01010750|O1|Outcome|LDX 50 mg|
392515|NCT01010750|O3|Outcome|Placebo|
392516|NCT01010750|O2|Outcome|MAS-IR 20 mg|
392517|NCT01010750|O1|Outcome|LDX 50 mg|
392518|NCT01010750|O3|Outcome|Placebo|
392519|NCT01010750|O2|Outcome|MAS-IR 20 mg|
392520|NCT01010750|O1|Outcome|LDX 50 mg|
392521|NCT01010750|O3|Outcome|Placebo|
392522|NCT01010750|O2|Outcome|MAS-IR 20 mg|
392523|NCT01010750|O1|Outcome|LDX 50 mg|
392524|NCT01010750|O3|Outcome|Placebo|
392525|NCT01010750|O2|Outcome|MAS-IR 20 mg|
392526|NCT01010750|O1|Outcome|LDX 50 mg|
392527|NCT01010750|O3|Outcome|Placebo|
392528|NCT01010750|O2|Outcome|MAS-IR 20 mg|
392529|NCT01010750|O1|Outcome|LDX 50 mg|
392530|NCT01010750|E3|Reported Event|Placebo|
392531|NCT01010750|E2|Reported Event|MAS-IR 20 mg|
392532|NCT01010750|E1|Reported Event|LDX 50 mg|
392533|NCT01010633|B3|Baseline|Total|Total of all reporting groups
392534|NCT01010633|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate
392535|NCT01010633|B1|Baseline|Loteprednol|Loteprednol etabonate 0.5%
392536|NCT01010633|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate
392537|NCT01010633|P1|Participant Flow|Loteprednol|Loteprednol etabonate 0.5%
392538|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
392539|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
392540|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
392541|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
392542|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
392543|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
392544|NCT01010633|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate
392545|NCT01010633|E1|Reported Event|Loteprednol|Loteprednol etabonate 0.5%
392546|NCT01010568|B1|Baseline|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
392547|NCT01010568|P1|Participant Flow|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
392548|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
392549|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
392550|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
392551|NCT01010568|E1|Reported Event|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
392552|NCT01010555|B1|Baseline|Overall|This reporting group includes all enrolled subjects.
392553|NCT01010555|P2|Participant Flow|Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A|Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
392554|NCT01010555|P1|Participant Flow|Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A|Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
392555|NCT01010555|O4|Outcome|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392556|NCT01010555|O3|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392557|NCT01010555|O2|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392558|NCT01010555|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392559|NCT01010555|E4|Reported Event|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392560|NCT01010555|E3|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392615|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392561|NCT01010555|E2|Reported Event|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392562|NCT01010555|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
392563|NCT01010503|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392564|NCT01010503|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392565|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392566|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392567|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392568|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392569|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392570|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392571|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392572|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392573|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392574|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392575|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392576|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392577|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392578|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392579|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392580|NCT01010503|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
392581|NCT01010477|B3|Baseline|Total|Total of all reporting groups
392582|NCT01010477|B2|Baseline|Placebo NS|Receives placebo (piperine containing) nasal spray
392583|NCT01010477|B1|Baseline|NNS Active|Receives nicotine (active) nasal spray
392584|NCT01010477|P2|Participant Flow|Placebo|Receives placebo (piperine)nasal spray
392585|NCT01010477|P1|Participant Flow|NNS Active|Receives active nicotine containing Nasal spray
392586|NCT01010477|O2|Outcome|Placebo|Receives placebo (piperine)nasal spray
392587|NCT01010477|O1|Outcome|NNS Active|Receives nicotine (active ) nasal spray
392588|NCT01010477|E2|Reported Event|Placebo|Receives placebo (piperine)nasal spray
392589|NCT01010477|E1|Reported Event|NNS Active|Receives nicotine (active) nasal spray
392590|NCT01010399|B1|Baseline|Boosted Lexiva With Lovaza|
392591|NCT01010399|P1|Participant Flow|Boosted Lexiva With Lovaza|
392592|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
392593|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
392594|NCT01010399|E1|Reported Event|Boosted Lexiva With Lovaza|
392595|NCT01010282|B4|Baseline|Total|Total of all reporting groups
392596|NCT01010282|B3|Baseline|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392597|NCT01010282|B2|Baseline|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392598|NCT01010282|B1|Baseline|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392599|NCT01010282|P3|Participant Flow|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392600|NCT01010282|P2|Participant Flow|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392601|NCT01010282|P1|Participant Flow|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392602|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392603|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392604|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392605|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392606|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392607|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392608|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392609|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392610|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392611|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392612|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392613|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392614|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392617|NCT01010282|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
392618|NCT01010282|E2|Reported Event|Artificial Tears Formulation 2|Artificial Tears Formulation 2
392619|NCT01010282|E1|Reported Event|Artificial Tears Formulation 1|Artificial Tears Formulation 1
392620|NCT01010230|B3|Baseline|Total|Total of all reporting groups
392621|NCT01010230|B2|Baseline|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392622|NCT01010230|B1|Baseline|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392623|NCT01010230|P2|Participant Flow|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392624|NCT01010230|P1|Participant Flow|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392625|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392626|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392627|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392628|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392629|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392630|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392631|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392667|NCT01010061|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392746|NCT01009762|B2|Baseline|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
392632|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392633|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392634|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392635|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392636|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392637|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392638|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392639|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392640|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392641|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392642|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392643|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392747|NCT01009762|B1|Baseline|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
392748|NCT01009762|P2|Participant Flow|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
392644|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392645|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392646|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392647|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392648|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392649|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392650|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392651|NCT01010230|E2|Reported Event|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
392652|NCT01010230|E1|Reported Event|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
392653|NCT01010204|B3|Baseline|Total|Total of all reporting groups
392654|NCT01010204|B2|Baseline|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392655|NCT01010204|B1|Baseline|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392668|NCT01010061|B1|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392750|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
392656|NCT01010204|P2|Participant Flow|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392657|NCT01010204|P1|Participant Flow|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392658|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392659|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392660|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392661|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392662|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392663|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392664|NCT01010204|E2|Reported Event|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392665|NCT01010204|E1|Reported Event|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
392666|NCT01010061|B3|Baseline|Total|Total of all reporting groups
392749|NCT01009762|P1|Participant Flow|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
392669|NCT01010061|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392670|NCT01010061|P1|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392671|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392672|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392673|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392674|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392675|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392676|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392677|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392678|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392679|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392680|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392681|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392682|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392683|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392684|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392685|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392686|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392687|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392688|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392689|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392690|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392691|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392692|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392693|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392694|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392695|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392696|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392697|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392698|NCT01010061|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
392699|NCT01010061|E1|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
392700|NCT01010009|B4|Baseline|Total|Total of all reporting groups
392701|NCT01010009|B3|Baseline|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
392702|NCT01010009|B2|Baseline|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
392703|NCT01010009|B1|Baseline|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
392704|NCT01010009|P3|Participant Flow|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
392705|NCT01010009|P2|Participant Flow|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
392706|NCT01010009|P1|Participant Flow|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
392707|NCT01010009|O3|Outcome|Placebo|
392708|NCT01010009|O2|Outcome|Resveratrol 500mg|
392709|NCT01010009|O1|Outcome|Resveratrol 250mg|
392710|NCT01010009|O3|Outcome|Placebo|
392711|NCT01010009|O2|Outcome|Resveratrol 500mg|
392712|NCT01010009|O1|Outcome|Resveratrol 250mg|
392713|NCT01010009|O3|Outcome|Placebo|
392714|NCT01010009|O2|Outcome|Resveratrol 500mg|
392715|NCT01010009|O1|Outcome|Resveratrol 250mg|
392716|NCT01010009|E3|Reported Event|Placebo|
392717|NCT01010009|E2|Reported Event|Resveratrol 500mg|
392718|NCT01010009|E1|Reported Event|Resveratrol 250mg|
392719|NCT01009983|B1|Baseline|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
392720|NCT01009983|P1|Participant Flow|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
392721|NCT01009983|O1|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
392722|NCT01009983|O1|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
392723|NCT01009983|O1|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
392724|NCT01009983|O1|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
392725|NCT01009983|E1|Reported Event|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
392744|NCT01009840|E1|Reported Event|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392745|NCT01009762|B3|Baseline|Total|Total of all reporting groups
392726|NCT01009931|B1|Baseline|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
392727|NCT01009931|P1|Participant Flow|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
392728|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
392729|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
392730|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
392731|NCT01009931|E1|Reported Event|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
392732|NCT01009840|B1|Baseline|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392733|NCT01009840|P1|Participant Flow|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT).
392734|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392735|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392736|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392737|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392738|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392739|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392740|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392741|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392742|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392743|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
392751|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
392752|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
392753|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
392754|NCT01009762|O2|Outcome|Placebo|participants receiving placebo (=saline)
392755|NCT01009762|O1|Outcome|Vaccinee|participants receiving the vaccine
392756|NCT01009762|E2|Reported Event|Placebo|Participants receiving placebo (saline)
392757|NCT01009762|E1|Reported Event|Vaccinee|"participants receiving the vaccine called AFO-18"
392758|NCT01009645|B5|Baseline|Total|Total of all reporting groups
392759|NCT01009645|B4|Baseline|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
392760|NCT01009645|B3|Baseline|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
392761|NCT01009645|B2|Baseline|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
392762|NCT01009645|B1|Baseline|Fact Only|The educational message used will contain facts only.
392763|NCT01009645|P4|Participant Flow|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
392764|NCT01009645|P3|Participant Flow|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
392765|NCT01009645|P2|Participant Flow|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
392766|NCT01009645|P1|Participant Flow|Fact Only|The educational message used will contain facts only.
392767|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
392768|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
392769|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
392770|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
392771|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
392772|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
392773|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
392774|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
392775|NCT01009645|E4|Reported Event|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
392776|NCT01009645|E3|Reported Event|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
392777|NCT01009645|E2|Reported Event|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
392778|NCT01009645|E1|Reported Event|Fact Only|The educational message used will contain facts only.
392779|NCT01009619|B3|Baseline|Total|Total of all reporting groups
392780|NCT01009619|B2|Baseline|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392781|NCT01009619|B1|Baseline|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392782|NCT01009619|P2|Participant Flow|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392783|NCT01009619|P1|Participant Flow|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392784|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392785|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392786|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392787|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392788|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392789|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392790|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392791|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392792|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392793|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392794|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392795|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392796|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392797|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392798|NCT01009619|E2|Reported Event|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
392799|NCT01009619|E1|Reported Event|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
392800|NCT01009580|B3|Baseline|Total|Total of all reporting groups
392801|NCT01009580|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
392802|NCT01009580|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
392803|NCT01009580|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
392804|NCT01009580|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
392805|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
392806|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
392807|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
392808|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
392809|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
392810|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
392811|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
392812|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
392813|NCT01009580|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
392814|NCT01009580|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
392815|NCT01009554|B3|Baseline|Total|Total of all reporting groups
392816|NCT01009554|B2|Baseline|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392817|NCT01009554|B1|Baseline|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392818|NCT01009554|P2|Participant Flow|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392819|NCT01009554|P1|Participant Flow|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392820|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392821|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392822|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392823|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392824|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392825|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392826|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392827|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392828|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392829|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392830|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392831|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392832|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392833|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392834|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392835|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392836|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392837|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392881|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392838|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392839|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392840|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392841|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392842|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392843|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392844|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392845|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392846|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392847|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392848|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392849|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392850|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392851|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392852|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392853|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392854|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392855|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392856|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392857|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392858|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392859|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392860|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392861|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392862|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392863|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392864|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392865|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392866|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392867|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392868|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392869|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392870|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392871|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392872|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392873|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392874|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392875|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392876|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392877|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392878|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392879|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392880|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392882|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392883|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392884|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392885|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392886|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392887|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392888|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392889|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392890|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392891|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392892|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392893|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392894|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392895|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392896|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392897|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392898|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392899|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392900|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392901|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392902|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392903|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392904|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392905|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392906|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392907|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392908|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392909|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392910|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392911|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392912|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392913|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392914|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392915|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392916|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392917|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392918|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392919|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392920|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392921|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392922|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392923|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392924|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392925|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392926|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392927|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392928|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392929|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392930|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392931|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392932|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392933|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392934|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392935|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392936|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392937|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392938|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392939|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392940|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392941|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392942|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392943|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392944|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392945|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392946|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392947|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392948|NCT01009554|E2|Reported Event|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
392949|NCT01009554|E1|Reported Event|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
392950|NCT01009515|B1|Baseline|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
392951|NCT01009515|P1|Participant Flow|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
392952|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
392953|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
392954|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
392955|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
392956|NCT01009515|E1|Reported Event|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
392957|NCT01009463|B5|Baseline|Total|Total of all reporting groups
392958|NCT01009463|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
393004|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
393005|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
393006|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
392959|NCT01009463|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392960|NCT01009463|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392961|NCT01009463|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392962|NCT01009463|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392963|NCT01009463|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392964|NCT01009463|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392965|NCT01009463|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392966|NCT01009463|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
392967|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392968|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392969|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392970|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392971|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392972|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392973|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392974|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392975|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392976|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392977|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392978|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. )
392979|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
393007|NCT01009333|E3|Reported Event|High InterStim Rate Setting at 25 Hz|
393008|NCT01009333|E2|Reported Event|Medium InterStim Rate Setting at 14 Hz|
393009|NCT01009333|E1|Reported Event|Low InterStim Rate Setting at 5.2 Hz|
392980|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392981|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392982|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392983|NCT01009463|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392984|NCT01009463|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392985|NCT01009463|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392986|NCT01009463|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
392987|NCT01009346|B1|Baseline|Study Arm|"Drug: RAD001~Other Names:~Everolimus~Dose Level -1 2.5mg/day~Dose Level 1 5mg/day*~Dose Level 2 10mg/day~MTD RAD001 Drug: Cetuximab~Other Names:~Erbitux~250mg/m2/week Drug: Cisplatin~Other Names:~cisplatinum CDDP cis-diamminedichloroplatinum(II)~40mg/m2 Day 1, 8 every 28 days Drug: Carboplatin~Other Names:~cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)~Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:~Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance."
392988|NCT01009346|P1|Participant Flow|RAD001|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
392989|NCT01009346|O1|Outcome|Study Arm (RAD001)|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
392990|NCT01009346|E1|Reported Event|Group 1|
392991|NCT01009333|B1|Baseline|All Study Participants|
392992|NCT01009333|P6|Participant Flow|Start at 25 Hz, Then 14 Hz, Then 5.2 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
392993|NCT01009333|P5|Participant Flow|Start at 25 Hz, Then 5.2 Hz, Then 14 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
392994|NCT01009333|P4|Participant Flow|Start at 14 Hz, Then 25 Hz, Then 5.2 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
392995|NCT01009333|P3|Participant Flow|Start at 14 Hz, Then 5.2 Hz, Then 25 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
392996|NCT01009333|P2|Participant Flow|Start at 5.2 Hz, Then 25 Hz, Then 14 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
392997|NCT01009333|P1|Participant Flow|Start at 5.2 Hz, Then 14 Hz, Then 25 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
392998|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
392999|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
393000|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
393001|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
393002|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
393003|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
393010|NCT01009203|B1|Baseline|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
393011|NCT01009203|P1|Participant Flow|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
393012|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
393013|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
393014|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
393015|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
393016|NCT01009203|E1|Reported Event|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
393017|NCT01009138|B3|Baseline|Total|Total of all reporting groups
393018|NCT01009138|B2|Baseline|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393019|NCT01009138|B1|Baseline|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393020|NCT01009138|P2|Participant Flow|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393021|NCT01009138|P1|Participant Flow|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393022|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393023|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393024|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393025|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393026|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393027|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393028|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393029|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393030|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393031|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393032|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393033|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393034|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393035|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393036|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393037|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393038|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393039|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393040|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393041|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393042|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393043|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393092|NCT01009086|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
393093|NCT01009086|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
393044|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393045|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393046|NCT01009138|E2|Reported Event|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
393047|NCT01009138|E1|Reported Event|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
393048|NCT01009099|B3|Baseline|Total|Total of all reporting groups
393049|NCT01009099|B2|Baseline|Arm 2|"exercise training~exercise training: treadmill exercise training"
393050|NCT01009099|B1|Baseline|Arm 1|"exercise training with breathing retraining~breathing retraining: breathing retraining using a metronome~exercise training: treadmill exercise training"
393051|NCT01009099|P2|Participant Flow|Exercise Training|treadmill exercise training
393052|NCT01009099|P1|Participant Flow|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
393053|NCT01009099|O2|Outcome|Exercise Training|treadmill exercise training
393054|NCT01009099|O1|Outcome|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
393055|NCT01009099|E2|Reported Event|Exercise Training|treadmill exercise training
393056|NCT01009099|E1|Reported Event|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
393057|NCT01009086|B4|Baseline|Total|Total of all reporting groups
393058|NCT01009086|B3|Baseline|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
393059|NCT01009086|B2|Baseline|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
393060|NCT01009086|B1|Baseline|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
393061|NCT01009086|P3|Participant Flow|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
393062|NCT01009086|P2|Participant Flow|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
393063|NCT01009086|P1|Participant Flow|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
393064|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
393065|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393066|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393067|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
393068|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
393069|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393070|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393637|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
393071|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
393072|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
393073|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393074|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393075|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
393076|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
393077|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393078|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393079|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
393080|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
393081|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393082|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393083|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
393084|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
393085|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393086|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
393087|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
393088|NCT01009086|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
393089|NCT01009086|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
393090|NCT01009086|E5|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
393091|NCT01009086|E4|Reported Event|Placebo (After CP)|After Controlled period (Week 16-24) – participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
393638|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
393094|NCT01009086|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
393095|NCT01009060|B3|Baseline|Total|Total of all reporting groups
393096|NCT01009060|B2|Baseline|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393097|NCT01009060|B1|Baseline|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393098|NCT01009060|P2|Participant Flow|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393099|NCT01009060|P1|Participant Flow|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393100|NCT01009060|O4|Outcome|GSK239512 80 mcg|Par. received GSK239512 80 mcg daily as dose level 4 in the fourth week of study and continued to receive from fifth to seventh week as maintenance phase.
393101|NCT01009060|O3|Outcome|GSK239512 40 mcg|Par. received GSK239512 40 mcg daily as dose level 3 in the third week of study.
393102|NCT01009060|O2|Outcome|GSK239512 20 mcg|Par. received GSK239512 20 mcg daily as dose level 2 in the second week of study.
393103|NCT01009060|O1|Outcome|GSK239512 10 mcg|Par. received GSK239512 10 mcg daily as dose level 1 in the first week of study.
393104|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393105|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393106|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393107|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393108|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393109|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393110|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393111|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393112|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393113|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393114|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393115|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393116|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393117|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393118|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393119|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393120|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393121|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393122|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393123|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393124|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393639|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
393125|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393126|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393127|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393128|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393129|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393130|NCT01009060|O2|Outcome|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393131|NCT01009060|O1|Outcome|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393132|NCT01009060|E2|Reported Event|GSK239512|Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 μg GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.
393133|NCT01009060|E1|Reported Event|Placebo|Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.
393134|NCT01009047|B3|Baseline|Total|Total of all reporting groups
393135|NCT01009047|B2|Baseline|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393136|NCT01009047|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393137|NCT01009047|P2|Participant Flow|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393138|NCT01009047|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393139|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393140|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393141|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393142|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393143|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393144|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393145|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393146|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393147|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393148|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393149|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393150|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393151|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393152|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393153|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393351|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393154|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393155|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393156|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393157|NCT01009047|E2|Reported Event|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
393158|NCT01009047|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
393159|NCT01009034|B1|Baseline|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
393160|NCT01009034|P1|Participant Flow|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
393161|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
393162|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
393163|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
393164|NCT01009034|E1|Reported Event|12 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
393165|NCT01008995|B3|Baseline|Total|Total of all reporting groups
393166|NCT01008995|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
393167|NCT01008995|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
393168|NCT01008995|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
393169|NCT01008995|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
393170|NCT01008995|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
393171|NCT01008995|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
393172|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
393173|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
393174|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
393175|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
393176|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
393177|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
393178|NCT01008995|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
393179|NCT01008995|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
393180|NCT01008995|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
393181|NCT01008995|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
393182|NCT01008969|B1|Baseline|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
393183|NCT01008969|P1|Participant Flow|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
393184|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
393631|NCT01007123|E1|Reported Event|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393185|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
393186|NCT01008969|E1|Reported Event|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
393187|NCT01008943|B1|Baseline|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
393188|NCT01008943|P1|Participant Flow|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
393189|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
393190|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
393191|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
393192|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
393193|NCT01008943|E1|Reported Event|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
393194|NCT01008904|B1|Baseline|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
393195|NCT01008904|P1|Participant Flow|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
393196|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
393197|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
393198|NCT01008904|E1|Reported Event|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
393199|NCT01008722|B3|Baseline|Total|Total of all reporting groups
393200|NCT01008722|B2|Baseline|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
393201|NCT01008722|B1|Baseline|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
393202|NCT01008722|P2|Participant Flow|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
393203|NCT01008722|P1|Participant Flow|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
393204|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
393205|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
393206|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
393207|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
393208|NCT01008722|E2|Reported Event|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
393209|NCT01008722|E1|Reported Event|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
393210|NCT01008696|B3|Baseline|Total|Total of all reporting groups
393211|NCT01008696|B2|Baseline|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
393212|NCT01008696|B1|Baseline|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
393213|NCT01008696|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
393214|NCT01008696|P1|Participant Flow|Rabeprazole|Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days
393215|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
393216|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
393217|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
393218|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
393219|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
393220|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
393221|NCT01008696|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
393222|NCT01008696|E1|Reported Event|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
393345|NCT01008449|P2|Participant Flow|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393632|NCT01007110|B3|Baseline|Total|Total of all reporting groups
393223|NCT01008618|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393224|NCT01008618|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393225|NCT01008618|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393226|NCT01008618|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393227|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393228|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393229|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393230|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393231|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393232|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393233|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393234|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393633|NCT01007110|B2|Baseline|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
393235|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393236|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393237|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393238|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393239|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393240|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393241|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393242|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393243|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393244|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393245|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393246|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393413|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393247|NCT01008618|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393248|NCT01008618|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393249|NCT01008618|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393250|NCT01008605|B1|Baseline|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393251|NCT01008605|P1|Participant Flow|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393252|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
393253|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
393254|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
393255|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
393256|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
393257|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
393258|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
393259|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
393260|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
393261|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
393262|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
393263|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
393264|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
393265|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
393266|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
393267|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
393268|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393269|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393634|NCT01007110|B1|Baseline|Placebo|soy/corn oil placebo
393640|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
393270|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393271|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393272|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393273|NCT01008605|E1|Reported Event|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
393274|NCT01008553|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393275|NCT01008553|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393276|NCT01008553|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393277|NCT01008553|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393278|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393279|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393280|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393281|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393282|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393346|NCT01008449|P1|Participant Flow|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393635|NCT01007110|P2|Participant Flow|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
393283|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393284|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393285|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393286|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393287|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393288|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393289|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393290|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393291|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393292|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393293|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393294|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393347|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393492|NCT01007435|P1|Participant Flow|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393295|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393296|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393297|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393298|NCT01008553|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393299|NCT01008553|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
393300|NCT01008553|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
393301|NCT01008475|B8|Baseline|Total|Total of all reporting groups
393302|NCT01008475|B7|Baseline|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393303|NCT01008475|B6|Baseline|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393304|NCT01008475|B5|Baseline|Randomized Part: SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393305|NCT01008475|B4|Baseline|Safety Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393306|NCT01008475|B3|Baseline|Safety Part: EMD 525797 750 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393348|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393349|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393307|NCT01008475|B2|Baseline|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393308|NCT01008475|B1|Baseline|Safety Part: EMD 525797 250 mg + Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393309|NCT01008475|P7|Participant Flow|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393310|NCT01008475|P6|Participant Flow|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393311|NCT01008475|P5|Participant Flow|Randomized Part: Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393312|NCT01008475|P4|Participant Flow|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393313|NCT01008475|P3|Participant Flow|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393314|NCT01008475|P2|Participant Flow|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393315|NCT01008475|P1|Participant Flow|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393316|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393317|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393318|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393626|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393319|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393320|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393321|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393322|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393323|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393324|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393325|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393326|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393327|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393328|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393329|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393330|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393350|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393627|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393331|NCT01008475|O4|Outcome|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393332|NCT01008475|O3|Outcome|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393333|NCT01008475|O2|Outcome|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393334|NCT01008475|O1|Outcome|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393335|NCT01008475|E7|Reported Event|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393336|NCT01008475|E6|Reported Event|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393337|NCT01008475|E5|Reported Event|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393338|NCT01008475|E4|Reported Event|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393339|NCT01008475|E3|Reported Event|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393340|NCT01008475|E2|Reported Event|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393341|NCT01008475|E1|Reported Event|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
393342|NCT01008449|B3|Baseline|Total|Total of all reporting groups
393343|NCT01008449|B2|Baseline|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393344|NCT01008449|B1|Baseline|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393628|NCT01007123|E4|Reported Event|Placebo|Administered once daily for the duration of the study
393352|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393353|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393354|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393355|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393356|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393357|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393358|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393359|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393360|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393361|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393362|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393363|NCT01008449|E2|Reported Event|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
393364|NCT01008449|E1|Reported Event|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
393365|NCT01008319|B3|Baseline|Total|Total of all reporting groups
393366|NCT01008319|B2|Baseline|Stair-Step Administration|
393367|NCT01008319|B1|Baseline|Traditional Administration|
393368|NCT01008319|P2|Participant Flow|Stair-Step Administration|The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
393369|NCT01008319|P1|Participant Flow|Traditional Administration|"The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 5). If ovulation does not occur by day 21 then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.~This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg)."
393370|NCT01008319|O2|Outcome|Stair-Step Protocol|Proportion of subjects that delivered in the stair-step protocol.
393371|NCT01008319|O1|Outcome|Traditional Protocol|Proportion of subjects that delivered in the traditional protocol.
393372|NCT01008319|O2|Outcome|Stair-Step Protocol|The proportion that ovulated at the dose of Clomid of 60 patients in the stair-step protocol.
393373|NCT01008319|O1|Outcome|Traditional Protocol|The proportion that ovulated at the dose of Clomid of 60 patients in the traditional protocol.
393374|NCT01008319|O2|Outcome|Stair-Step Administration|The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
393375|NCT01008319|O1|Outcome|Traditional Administration|"The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.~clomiphene citrate: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present."
393414|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393415|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393376|NCT01008319|E2|Reported Event|Stair-Step Administration|The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
393377|NCT01008319|E1|Reported Event|Traditional Administration|"The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.~clomiphene citrate: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present."
393378|NCT01008280|B3|Baseline|Total|Total of all reporting groups
393379|NCT01008280|B2|Baseline|Placebo|"placebo given tid~placebo: placebo pill tid"
393380|NCT01008280|B1|Baseline|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
393381|NCT01008280|P2|Participant Flow|Placebo|"placebo given tid~placebo: placebo pill tid"
393382|NCT01008280|P1|Participant Flow|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
393383|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
393384|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
393385|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
393386|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
393387|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
393388|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
393389|NCT01008280|E2|Reported Event|Placebo|"placebo given tid~placebo: placebo pill tid"
393390|NCT01008280|E1|Reported Event|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
393391|NCT01007916|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
393392|NCT01007916|P2|Participant Flow|Habitual / Lotrafilcon B|Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
393393|NCT01007916|P1|Participant Flow|Lotrafilcon B / Habitual|Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
393394|NCT01007916|O2|Outcome|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
393395|NCT01007916|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
393396|NCT01007916|E2|Reported Event|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
393397|NCT01007916|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
393398|NCT01007942|B3|Baseline|Total|Total of all reporting groups
393399|NCT01007942|B2|Baseline|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393400|NCT01007942|B1|Baseline|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393401|NCT01007942|P2|Participant Flow|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393402|NCT01007942|P1|Participant Flow|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393403|NCT01007942|O2|Outcome|Everolimus Placebo|Oral placebo everolimus of 5 mg/day
393404|NCT01007942|O1|Outcome|Everolimus|Oral everolimus of 5 mg/day
393405|NCT01007942|O2|Outcome|Everolimus Placebo|Oral placebo everolimus of 5 mg/day
393406|NCT01007942|O1|Outcome|Everolimus|Oral everolimus of 5 mg/day
393407|NCT01007942|O2|Outcome|Everolimus|Oral everolimus of 5 mg/day
393408|NCT01007942|O1|Outcome|Everolimus 2.5 mg|Oral everolimus of 2.5 mg/day
393409|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393410|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393411|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393412|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393629|NCT01007123|E3|Reported Event|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393416|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393417|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393418|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393419|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393420|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393421|NCT01007942|E2|Reported Event|Placebo + Trastuzumab + Vinorelbine|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393422|NCT01007942|E1|Reported Event|Everolimus + Trastuzumab + Vinorelbine|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
393423|NCT01007838|B5|Baseline|Total|Total of all reporting groups
393424|NCT01007838|B4|Baseline|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393425|NCT01007838|B3|Baseline|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393426|NCT01007838|B2|Baseline|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393427|NCT01007838|B1|Baseline|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393428|NCT01007838|P4|Participant Flow|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393429|NCT01007838|P3|Participant Flow|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393430|NCT01007838|P2|Participant Flow|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393431|NCT01007838|P1|Participant Flow|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393432|NCT01007838|O4|Outcome|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393433|NCT01007838|O3|Outcome|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393434|NCT01007838|O2|Outcome|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393435|NCT01007838|O1|Outcome|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393436|NCT01007838|E4|Reported Event|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393437|NCT01007838|E3|Reported Event|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393438|NCT01007838|E2|Reported Event|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
393439|NCT01007838|E1|Reported Event|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
393440|NCT01007812|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
393441|NCT01007812|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
393442|NCT01007812|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
393443|NCT01007812|O2|Outcome|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
393444|NCT01007812|O1|Outcome|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
393445|NCT01007812|E2|Reported Event|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
393446|NCT01007812|E1|Reported Event|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
393447|NCT01007656|B1|Baseline|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393636|NCT01007110|P1|Participant Flow|Placebo|soy/corn oil placebo
393448|NCT01007656|P1|Participant Flow|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393449|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393450|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393451|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393452|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393453|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393454|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393455|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393456|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393457|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393458|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393459|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393460|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393461|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393462|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393463|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393464|NCT01007656|E1|Reported Event|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
393465|NCT01007643|B3|Baseline|Total|Total of all reporting groups
393466|NCT01007643|B2|Baseline|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393467|NCT01007643|B1|Baseline|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393468|NCT01007643|P2|Participant Flow|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393469|NCT01007643|P1|Participant Flow|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393470|NCT01007643|O2|Outcome|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393471|NCT01007643|O1|Outcome|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393472|NCT01007643|E2|Reported Event|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393473|NCT01007643|E1|Reported Event|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
393474|NCT01007552|B1|Baseline|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393475|NCT01007552|P1|Participant Flow|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393476|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393477|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393478|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393479|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393480|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393481|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393482|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393483|NCT01007552|E1|Reported Event|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
393484|NCT01007435|B5|Baseline|Total|Total of all reporting groups
393485|NCT01007435|B4|Baseline|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393486|NCT01007435|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393487|NCT01007435|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393488|NCT01007435|B1|Baseline|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393489|NCT01007435|P4|Participant Flow|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393490|NCT01007435|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393491|NCT01007435|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393630|NCT01007123|E2|Reported Event|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393493|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393494|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393495|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393496|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393497|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393498|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393499|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393500|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393501|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393502|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393503|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393504|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393505|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393506|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393507|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393508|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393509|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393510|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393511|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393512|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393513|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393514|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393515|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393516|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393517|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393518|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393519|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393520|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393521|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393522|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393523|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393524|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393525|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393526|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393527|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393528|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393529|NCT01007435|E4|Reported Event|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
393530|NCT01007435|E3|Reported Event|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393531|NCT01007435|E2|Reported Event|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
393532|NCT01007435|E1|Reported Event|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
393533|NCT01007396|B1|Baseline|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
393534|NCT01007396|P1|Participant Flow|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
393535|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
393536|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
393537|NCT01007396|E1|Reported Event|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
393538|NCT01007253|B1|Baseline|Entire Study Population|Includes groups randomized to receive PL/PL first, FF/PL first, PL/OLO first, and FF/OLO first.
393539|NCT01007253|P4|Participant Flow|PL/PL, FF/PL, PL/OLO, FF/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL),~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO)."
393540|NCT01007253|P3|Participant Flow|FF/OLO, PL/PL, FF/PL, PL/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO)."
393541|NCT01007253|P2|Participant Flow|PL/OLO, FF/OLO, PL/PL, FF/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL), and~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)."
393542|NCT01007253|P1|Participant Flow|FF/PL, PL/OLO, FF/OLO, PL/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and~placebo (PL) nasal spray and PL eye drops (PL/PL)."
393543|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393544|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393545|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
393546|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
393547|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393548|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393549|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
393550|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
393551|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393552|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393553|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
393554|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
393555|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393556|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393557|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
393558|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
393559|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393560|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393561|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
393562|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
393563|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393564|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393565|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
393566|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
393567|NCT01007253|E4|Reported Event|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393568|NCT01007253|E3|Reported Event|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
393569|NCT01007253|E2|Reported Event|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
393570|NCT01007253|E1|Reported Event|PL/PL|placebo (PL) nasal spray and PL eye drops
393571|NCT01007149|B3|Baseline|Total|Total of all reporting groups
393572|NCT01007149|B2|Baseline|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393573|NCT01007149|B1|Baseline|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393574|NCT01007149|P2|Participant Flow|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393575|NCT01007149|P1|Participant Flow|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393576|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393577|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393578|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393579|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393580|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393581|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393582|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393583|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393584|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393585|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393586|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393587|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393588|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393589|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393590|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393591|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393592|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393593|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393594|NCT01007149|E2|Reported Event|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
393595|NCT01007149|E1|Reported Event|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
393596|NCT01007123|B5|Baseline|Total|Total of all reporting groups
393597|NCT01007123|B4|Baseline|Placebo|Administered once daily for the duration of the study
393598|NCT01007123|B3|Baseline|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393599|NCT01007123|B2|Baseline|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393600|NCT01007123|B1|Baseline|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393601|NCT01007123|P4|Participant Flow|Placebo|Administered once daily for the duration of the study
393602|NCT01007123|P3|Participant Flow|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393603|NCT01007123|P2|Participant Flow|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393604|NCT01007123|P1|Participant Flow|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393605|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
393606|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393607|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393608|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393609|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393610|NCT01007123|O2|Outcome|Eobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393611|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393612|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
393613|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393614|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393615|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393616|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
393617|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393618|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393619|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393620|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
393621|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393622|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
393623|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
393624|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
393625|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
393641|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
393642|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
393643|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
393644|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
393645|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid (DHA)
393646|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
393647|NCT01007110|E2|Reported Event|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
393648|NCT01007110|E1|Reported Event|Placebo|soy/corn oil placebo
393649|NCT01007071|B3|Baseline|Total|Total of all reporting groups
393650|NCT01007071|B2|Baseline|Placebo|"Subjects were randomized to receive placebo for 16 weeks, and then were immediately crossed over to receive active study drug for 16 weeks~All subjects were diagnosed with growth hormone deficiency using standard testing."
393651|NCT01007071|B1|Baseline|Growth Hormone|"Subjects were randomized to receive growth Human Growth Hormone (1-134) (Nutropin) for 16 weeks~All subjects were diagnosed with growth hormone deficiency using standard testing."
393652|NCT01007071|P2|Participant Flow|Placebo|Subjects were randomized to receive placebo for 16 weeks, and then were immediately crossed over to receive active study drug for 16 weeks
393653|NCT01007071|P1|Participant Flow|Growth Hormone|Subjects were randomized to receive growth Human Growth Hormone (1-134) (Nutropin) for 16 weeks
393654|NCT01007071|O2|Outcome|Placebo|"Subjects randomized to placebo for 16 weeks~Placebo: Subjects randomized to placebo"
393655|NCT01007071|O1|Outcome|Growth Hormone|"Subjects randomized to growth hormone for 16 weeks~Human Growth Hormone (1-134): Subjects to receive growth hormone"
393656|NCT01007071|O2|Outcome|Placebo|Subjects randomized to placebo for 16 weeks Placebo: Subjects randomized to placebo
393657|NCT01007071|O1|Outcome|Growth Hormone|"Subjects randomized to growth hormone for 16 weeks~Human Growth Hormone (1-134): Subjects to receive growth hormone"
393658|NCT01007071|E2|Reported Event|Placebo|This arm received placebo for 16 weeks. There were no serious adverse evens in this group.
393659|NCT01007071|E1|Reported Event|Human Growth Hormone (1-134)|This arm received study drug for 16 weeks. There were no serious adverse events.
393660|NCT01006980|B3|Baseline|Total|Total of all reporting groups
393661|NCT01006980|B2|Baseline|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393662|NCT01006980|B1|Baseline|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393663|NCT01006980|P2|Participant Flow|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393664|NCT01006980|P1|Participant Flow|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393665|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393666|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393667|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393668|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393669|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393670|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393671|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393672|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393673|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393674|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393675|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393676|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393677|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393678|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
393679|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
393906|NCT01006590|E2|Reported Event|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393680|NCT01006980|E3|Reported Event|Vemurafenib After Crossover|Adverse events reported for this group include those occurring following switch to vemurafenib in those participants who switched from dacarbazine to vemurafenib during the study.
393681|NCT01006980|E2|Reported Event|Dacarbazine|"Adverse events reported for this group include those occurring in participants receiving dacarbazine starting at their baseline visit until study discontinuation or treatment switch.~Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length)."
393682|NCT01006980|E1|Reported Event|Vemurafenib|"Adverse events reported for this group include those occurring in participants receiving vemurafenib starting at their baseline visit.~Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg)."
393683|NCT01006889|B1|Baseline|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
393684|NCT01006889|P1|Participant Flow|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
393685|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
393686|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
393687|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
393688|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
393689|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
393690|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
393691|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
393692|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
393693|NCT01006889|E1|Reported Event|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
393694|NCT01006707|B1|Baseline|All Study Participants|All participants received placebo during Study Session 1 (placebo run-in), then were randomized to receive pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3, or pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393695|NCT01006707|P3|Participant Flow|Placebo, Then Ondansetron|Participants received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393696|NCT01006707|P2|Participant Flow|Ondansetron, Then Placebo|Participants received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393697|NCT01006707|P1|Participant Flow|Placebo Run-in|Participants received pretreatment with placebo to match ondansetron in Study Session 1 prior to randomization to cross-over treatment arms in Study Sessions 2 and 3.
393698|NCT01006707|O2|Outcome|Placebo|Participants received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393699|NCT01006707|O1|Outcome|Ondansetron|Participants received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393700|NCT01006707|O2|Outcome|Placebo|Participants received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded
393701|NCT01006707|O1|Outcome|Ondansetron|Participants received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393702|NCT01006707|O2|Outcome|Placebo|Participants received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393703|NCT01006707|O1|Outcome|Ondansetron|Participants received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393704|NCT01006707|O1|Outcome|All Ondansetron|All participants received pretreatment with ondansetron (8mg IV Bolus) and with placebo to match ondansetron. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393705|NCT01006707|E2|Reported Event|Placebo|Participants received placebo during Study Session 1 (placebo run-in), then received pretreatment with placebo to match ondansetron in Study Session 2 then ondansetron (8mg IV Bolus) in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393706|NCT01006707|E1|Reported Event|Ondansetron|Participants received placebo during Study Session 1 (placebo run-in), then received pretreatment with ondansetron (8mg IV Bolus) in Study Session 2 then placebo to match ondansetron in Study Session 3. Bolus was be given at the start of the study for 30 minutes by the unblinded investigator.
393707|NCT01006655|B3|Baseline|Total|Total of all reporting groups
393708|NCT01006655|B2|Baseline|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
393709|NCT01006655|B1|Baseline|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
393710|NCT01006655|P2|Participant Flow|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
393711|NCT01006655|P1|Participant Flow|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
393712|NCT01006655|O2|Outcome|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
393713|NCT01006655|O1|Outcome|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
393714|NCT01006655|E2|Reported Event|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
393715|NCT01006655|E1|Reported Event|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
393716|NCT01006629|B1|Baseline|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393717|NCT01006629|P1|Participant Flow|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393718|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393719|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393720|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393721|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393722|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393723|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393724|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393725|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393726|NCT01006629|E1|Reported Event|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
393727|NCT01006616|B5|Baseline|Total|Total of all reporting groups
393728|NCT01006616|B4|Baseline|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393729|NCT01006616|B3|Baseline|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393730|NCT01006616|B2|Baseline|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393731|NCT01006616|B1|Baseline|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393732|NCT01006616|P4|Participant Flow|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393733|NCT01006616|P3|Participant Flow|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393734|NCT01006616|P2|Participant Flow|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393735|NCT01006616|P1|Participant Flow|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years
393736|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393737|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393738|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393739|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393740|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393741|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393742|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393743|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393744|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393745|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393746|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393747|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393748|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393749|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393750|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393751|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393752|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393753|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393754|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393755|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393756|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393757|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393758|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393759|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393760|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393761|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393762|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393763|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393764|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393765|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393766|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393767|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393768|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393769|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393770|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393771|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393772|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393773|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393774|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393775|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
408541|NCT00975637|P5|Participant Flow|70 mg|AMG 827: 70 mg SC
393776|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393777|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393778|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393779|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393780|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393781|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393782|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393783|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393784|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393785|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393786|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393787|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393788|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393789|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393790|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393791|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393792|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393793|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393794|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393795|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393796|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393797|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393798|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393799|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393800|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393801|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393802|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393803|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393804|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393805|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393806|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393807|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393808|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393809|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393810|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393811|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393812|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393813|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393814|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
394002|NCT01005966|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Placebo fluoride free toothpaste
393815|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393816|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393817|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393818|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393819|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393820|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393821|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393822|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393823|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393824|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393825|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393826|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393827|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393828|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393829|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393830|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393831|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393832|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393833|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393834|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393835|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393836|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393837|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393838|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393839|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393840|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393841|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393842|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393843|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393844|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393845|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393846|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393847|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393848|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393849|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393850|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393851|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393852|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393853|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
395078|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
393854|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393855|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393856|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393857|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393858|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393859|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393860|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393861|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393862|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393863|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393864|NCT01006616|E4|Reported Event|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
393865|NCT01006616|E3|Reported Event|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
393866|NCT01006616|E2|Reported Event|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393867|NCT01006616|E1|Reported Event|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
393868|NCT01006603|B3|Baseline|Total|Total of all reporting groups
393869|NCT01006603|B2|Baseline|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393870|NCT01006603|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393871|NCT01006603|P2|Participant Flow|Glimepiride 1 - 6 mg|Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393872|NCT01006603|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393873|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393874|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393875|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393876|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393877|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393878|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393879|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393880|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393881|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393882|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393883|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393884|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393885|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393886|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393887|NCT01006603|E2|Reported Event|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
393888|NCT01006603|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
393889|NCT01006590|B3|Baseline|Total|Total of all reporting groups
393890|NCT01006590|B2|Baseline|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393891|NCT01006590|B1|Baseline|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393892|NCT01006590|P2|Participant Flow|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393893|NCT01006590|P1|Participant Flow|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393894|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393895|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393896|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393897|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393898|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393899|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393900|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393901|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393902|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393903|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393904|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
393905|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393907|NCT01006590|E1|Reported Event|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
393908|NCT01006356|B1|Baseline|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393909|NCT01006356|P1|Participant Flow|Hydromorphone Hydrochloride Oral Osmotic System|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393910|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393911|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393912|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393913|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393914|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393915|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393916|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393917|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393918|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393919|NCT01006356|E1|Reported Event|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
393920|NCT01006291|B4|Baseline|Total|Total of all reporting groups
393921|NCT01006291|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
393922|NCT01006291|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
393923|NCT01006291|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
393924|NCT01006291|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
393925|NCT01006291|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
393926|NCT01006291|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
393927|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
393928|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
393929|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
393930|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
393931|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
393932|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
393933|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
393934|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
393935|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
393936|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
393937|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
393938|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
393939|NCT01006291|E3|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
393940|NCT01006291|E2|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
393941|NCT01006291|E1|Reported Event|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
393942|NCT01006135|B1|Baseline|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
393943|NCT01006135|P1|Participant Flow|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
393944|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
393945|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
393946|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
393947|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
393948|NCT01006135|E1|Reported Event|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
393949|NCT01006122|B1|Baseline|Entire Study|Included all participants randomized to receive PF-03654746 first and placebo first.
393950|NCT01006122|P2|Participant Flow|Placebo First Then, PF-03654746|Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
393951|NCT01006122|P1|Participant Flow|PF-03654746 First, Then Placebo|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
393952|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393953|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393954|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393955|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393956|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393957|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393958|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393959|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393960|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393961|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393962|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393963|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393964|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393965|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393966|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393967|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393968|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393969|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393970|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
394003|NCT01005966|P4|Participant Flow|NaF Toothpaste (675ppmF)|Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)
393971|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393972|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393973|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393974|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393975|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393976|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393977|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393978|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393979|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393980|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393981|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393982|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393983|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393984|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393985|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393986|NCT01006122|E2|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
393987|NCT01006122|E1|Reported Event|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
393988|NCT01006018|B4|Baseline|Total|Total of all reporting groups
393989|NCT01006018|B3|Baseline|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
393990|NCT01006018|B2|Baseline|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
393991|NCT01006018|B1|Baseline|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
393992|NCT01006018|P3|Participant Flow|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
393993|NCT01006018|P2|Participant Flow|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
393994|NCT01006018|P1|Participant Flow|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
393995|NCT01006018|O3|Outcome|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
393996|NCT01006018|O2|Outcome|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
393997|NCT01006018|O1|Outcome|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
393998|NCT01006018|E3|Reported Event|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
393999|NCT01006018|E2|Reported Event|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
394000|NCT01006018|E1|Reported Event|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
394001|NCT01005966|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included.
394004|NCT01005966|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
394005|NCT01005966|P2|Participant Flow|Amine Fluoride(AmF) Toothpaste (1400ppmF)|Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)
394006|NCT01005966|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F]|Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)
394007|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo: Fluoride free toothpaste
394008|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
394009|NCT01005966|O3|Outcome|Na MFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
394010|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
394011|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
394012|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo - fluoride free toothpaste
394013|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/silica (675ppmF)
394014|NCT01005966|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF– 1000ppmF as NaMFP and 450ppmF as NaF)
394015|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF(1400ppmF)
394016|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
394017|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
394018|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
394019|NCT01005966|E6|Reported Event|Overall|
394020|NCT01005966|E5|Reported Event|Placebo Toothpaste (0ppmF)|Placebo: fluoride free toothpaste
394021|NCT01005966|E4|Reported Event|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
394022|NCT01005966|E3|Reported Event|NaMFP/ NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/ NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
394023|NCT01005966|E2|Reported Event|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
394024|NCT01005966|E1|Reported Event|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
394025|NCT01005914|B1|Baseline|Group 1|"Drug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily~Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
394026|NCT01005914|P1|Participant Flow|Group 1|"Drug:cyclophosphamide-Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours Drug:imatinib mesylate 600 mg/day Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion Drug: methylprednisolone Day 1-3: 50mg IV BID Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
394027|NCT01005914|O1|Outcome|Group 1|Cy D1- 3: 300 m g/m2 IV- 6 doses, mesna 600 mg/ m2 /day continuous IV D 1-3, ARAC D 2 & 3: 3g/m2 IV q12 X 4, Dex D1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV, imatinib mesylate 600 mg/day, MTX D1: 1g/ m2 200 mg/ m2 load IV plus 800 mg/ m2, methylprednisolone D 1-3: 50mg IV BID, pegaspargase D3/D4: 2,500 IU/ m2 IV, vincristine sulfate D4 & 11: 2 mg IV, Cy: D 1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day, continuous infusion D 1-3. ARAC D 2 & 3: 3g/m2 IV q12 X 4, dex: D 1-4; 11-14: 40 mg daily, doxorubicin hydrochloride: D 4: 50 mg/m2 IV, imatinib mesylate: 600 mg/day, MTX: D 1: 1g/ m2 200 mg/ m2load IV plus 800 mg/ m2 IV, methylprednisolone: D 1-3: 50mg IV BID, pegaspargase: D 3/D4: 2,500 IU/ m2 IV, vincristine sulfate: D 4 & 11: 2 mg IV, pharmacological study: C1A: pre-dose between Days 1 to 4, C1A: D11 or 12., C1A: D18 or 19, C 1A: D25 or 26, C1A: D32 or 33 C1B: pre-dose between D1-3, C1B: D1 or 11 C1B: D17 or 18, C1B: D24 or 25 C1B: D31 or 32
394028|NCT01005914|E1|Reported Event|Group 1|"cyclophosphamide D1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day cont. IV D1-3, cytarabine D2 & 3: 3g/m2 IV, dexD1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
394029|NCT01005901|B3|Baseline|Total|Total of all reporting groups
394030|NCT01005901|B2|Baseline|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394031|NCT01005901|B1|Baseline|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394032|NCT01005901|P2|Participant Flow|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394033|NCT01005901|P1|Participant Flow|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394034|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394035|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394036|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394037|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394038|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394039|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394040|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394041|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394042|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394043|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394044|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394045|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394046|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394047|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394048|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394049|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394050|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394051|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394052|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394053|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394054|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394055|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394056|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394057|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394094|NCT01005888|E1|Reported Event|C1INH-nf|
395079|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
394058|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394059|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394060|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394061|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394062|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394063|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394064|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394065|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394066|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394067|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394068|NCT01005901|E2|Reported Event|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394069|NCT01005901|E1|Reported Event|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
394070|NCT01005888|B5|Baseline|Total|Total of all reporting groups
394071|NCT01005888|B4|Baseline|Randomized, Not Treated|One subject was randomized but withdrew prior to receiving study drug.
394072|NCT01005888|B3|Baseline|Open-label C1INH-nf Only|One subject received open-label C1INH-nf but withdrew prior to randomization.
394073|NCT01005888|B2|Baseline|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
394074|NCT01005888|B1|Baseline|C1INH-nf First, Then Placebo|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
394075|NCT01005888|P2|Participant Flow|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
394076|NCT01005888|P1|Participant Flow|C1INH-nf First, Then Placebo|1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
394077|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394078|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394079|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394080|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394081|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394082|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394083|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394084|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394085|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394086|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394087|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394088|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394089|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394090|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394091|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394092|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
394093|NCT01005888|E2|Reported Event|Placebo|
394095|NCT01005875|B1|Baseline|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394096|NCT01005875|P1|Participant Flow|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394097|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394098|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394099|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394100|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394101|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394102|NCT01005875|E1|Reported Event|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
394103|NCT01005745|B1|Baseline|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
394104|NCT01005745|P1|Participant Flow|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
394105|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
394106|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
394107|NCT01005745|E1|Reported Event|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
394108|NCT01005732|B1|Baseline|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
394137|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
395080|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
394109|NCT01005732|P1|Participant Flow|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
394110|NCT01005732|O1|Outcome|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
394111|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394112|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394113|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394114|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394115|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394116|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394117|NCT01005732|O4|Outcome|Uninjured Forearm Skin|Hardness of uninjured forearm skin is provided for comparison.
394118|NCT01005732|O3|Outcome|Kneecap|Hardness of uninjured skin over a bony prominence is provided for comparison.
394119|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394120|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394121|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394122|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
394123|NCT01005732|E1|Reported Event|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
394124|NCT01005719|B1|Baseline|Overall Study|
394125|NCT01005719|P6|Participant Flow|No Treatment-Prevacid®-Zegerid|Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3
394126|NCT01005719|P5|Participant Flow|No Treatment-Zegerid-Prevacid®|Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3
394127|NCT01005719|P4|Participant Flow|Prevacid®-No Treatment-Zegerid|Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3
394128|NCT01005719|P3|Participant Flow|Prevacid®-Zegerid-No Treatment|Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3
394129|NCT01005719|P2|Participant Flow|Zegerid-No Treatment-Prevacid®|Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3
394130|NCT01005719|P1|Participant Flow|Zegerid-Prevacid®-No Treatment|Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3.
394131|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving in Prevacid® Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394132|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394133|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394134|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394135|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394136|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394258|NCT01005459|E1|Reported Event|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
394138|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394139|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394140|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394141|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394142|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394143|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394144|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394145|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394146|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394147|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394148|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394149|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394150|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394151|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394152|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394153|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394154|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394155|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394156|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394157|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394158|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394159|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394160|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394259|NCT01005407|B3|Baseline|Total|Total of all reporting groups
395081|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
394161|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394162|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394163|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394164|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394165|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394166|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394167|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394168|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394169|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394170|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394171|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394172|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394173|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394174|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394175|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394176|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394177|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394178|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394179|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394180|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394181|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394182|NCT01005719|E3|Reported Event|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394183|NCT01005719|E2|Reported Event|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394260|NCT01005407|B2|Baseline|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24"
394184|NCT01005719|E1|Reported Event|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
394185|NCT01005706|B3|Baseline|Total|Total of all reporting groups
394186|NCT01005706|B2|Baseline|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
394187|NCT01005706|B1|Baseline|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
394188|NCT01005706|P2|Participant Flow|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
394189|NCT01005706|P1|Participant Flow|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
394190|NCT01005706|O2|Outcome|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
394191|NCT01005706|O1|Outcome|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
394192|NCT01005706|E2|Reported Event|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
394193|NCT01005706|E1|Reported Event|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
394194|NCT01005680|B3|Baseline|Total|Total of all reporting groups
394195|NCT01005680|B2|Baseline|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
394196|NCT01005680|B1|Baseline|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
394197|NCT01005680|P2|Participant Flow|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394198|NCT01005680|P1|Participant Flow|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394199|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394200|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394201|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394202|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394203|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
408542|NCT00975637|P4|Participant Flow|Placebo|Placebo: Placebo SC
394204|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394205|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394206|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394207|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394208|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394209|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394210|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394211|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394212|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394213|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394214|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394215|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394216|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
394217|NCT01005680|E2|Reported Event|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
394218|NCT01005680|E1|Reported Event|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
394219|NCT01005602|B3|Baseline|Total|Total of all reporting groups
394220|NCT01005602|B2|Baseline|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
394221|NCT01005602|B1|Baseline|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
394222|NCT01005602|P2|Participant Flow|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
394223|NCT01005602|P1|Participant Flow|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
394224|NCT01005602|O4|Outcome|GA Genotype|
394225|NCT01005602|O3|Outcome|TT Genotype|
394226|NCT01005602|O2|Outcome|GT Genotype|
394227|NCT01005602|O1|Outcome|Wild Type (GG)|
394228|NCT01005602|O3|Outcome|TT Genotype|
394229|NCT01005602|O2|Outcome|CT Genotype|
394230|NCT01005602|O1|Outcome|Wild Type (CC)|
394231|NCT01005602|O3|Outcome|TT Genotype|
394232|NCT01005602|O2|Outcome|CT Genotype|
394233|NCT01005602|O1|Outcome|Wild Type|Genotypes for the ABCB1 single nucleotide polymorphism C1236T
394234|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
394235|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
394236|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
394261|NCT01005407|B1|Baseline|HEPLISAV and Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
394237|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
394238|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
394239|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
394240|NCT01005602|E2|Reported Event|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
394241|NCT01005602|E1|Reported Event|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
394242|NCT01005576|B1|Baseline|Conditioning Regimen|"Hydroxyurea days -50 to -21 Alemtuzumab days -21 to -19 Fludarabine days -8 to -4 Thiotepa day -4 Melphalan day -3 Stem cell infusion day 0~Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan: Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394243|NCT01005576|P1|Participant Flow|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394244|NCT01005576|O1|Outcome|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394245|NCT01005576|O1|Outcome|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394246|NCT01005576|O1|Outcome|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394247|NCT01005576|O1|Outcome|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394248|NCT01005576|O1|Outcome|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394249|NCT01005576|E1|Reported Event|Conditioning Regimen|"Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan:~Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion"
394250|NCT01005459|B3|Baseline|Total|Total of all reporting groups
394251|NCT01005459|B2|Baseline|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
394252|NCT01005459|B1|Baseline|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
394253|NCT01005459|P2|Participant Flow|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
394254|NCT01005459|P1|Participant Flow|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
394255|NCT01005459|O2|Outcome|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
394256|NCT01005459|O1|Outcome|Tetracaine 2mg|Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
394257|NCT01005459|E2|Reported Event|Bupivacaine 2 mg|Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
394262|NCT01005407|P2|Participant Flow|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24"
394263|NCT01005407|P1|Participant Flow|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
394264|NCT01005407|O2|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24"
394265|NCT01005407|O1|Outcome|HEPLISAV and Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
394266|NCT01005407|O2|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24"
394267|NCT01005407|O1|Outcome|HEPLISAV and Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
394268|NCT01005407|E2|Reported Event|Engerix-B(1)|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24"
394269|NCT01005407|E1|Reported Event|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
394270|NCT01005355|B4|Baseline|Total|Total of all reporting groups
394271|NCT01005355|B3|Baseline|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394272|NCT01005355|B2|Baseline|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394273|NCT01005355|B1|Baseline|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394274|NCT01005355|P3|Participant Flow|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394275|NCT01005355|P2|Participant Flow|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394276|NCT01005355|P1|Participant Flow|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394277|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394278|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394279|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394280|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394281|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394282|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394392|NCT01005251|B2|Baseline|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
394393|NCT01005251|B1|Baseline|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
394394|NCT01005251|P5|Participant Flow|Placebo|PPI+Placebo
394283|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394284|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394285|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394286|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394287|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394288|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394289|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394290|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394291|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394292|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394293|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394294|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394295|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394296|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394297|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394395|NCT01005251|P4|Participant Flow|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
394396|NCT01005251|P3|Participant Flow|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
394397|NCT01005251|P2|Participant Flow|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
394298|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394299|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394300|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394301|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394302|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394303|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394304|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394305|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394306|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394307|NCT01005355|E3|Reported Event|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394308|NCT01005355|E2|Reported Event|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394309|NCT01005355|E1|Reported Event|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
394310|NCT01005329|B1|Baseline|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394311|NCT01005329|P1|Participant Flow|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394398|NCT01005251|P1|Participant Flow|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
394399|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
394400|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
394312|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394313|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394314|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394315|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394316|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394317|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394318|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394319|NCT01005329|E1|Reported Event|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
394320|NCT01005316|B4|Baseline|Total|Total of all reporting groups
394321|NCT01005316|B3|Baseline|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394322|NCT01005316|B2|Baseline|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394401|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
394323|NCT01005316|B1|Baseline|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394324|NCT01005316|P4|Participant Flow|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394325|NCT01005316|P3|Participant Flow|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394326|NCT01005316|P2|Participant Flow|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394327|NCT01005316|P1|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
394328|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394329|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394330|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394331|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394332|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394402|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
394403|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
394404|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
394333|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394334|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394335|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394336|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394337|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394338|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394339|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394340|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394341|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394342|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394343|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394344|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394345|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394346|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394347|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394348|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394349|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394350|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394351|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394405|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
394406|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
394407|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
394408|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
394409|NCT01005251|E5|Reported Event|Placebo|PPI+Placebo
394352|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394353|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394354|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394355|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394356|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394357|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394358|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394359|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394360|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394410|NCT01005251|E4|Reported Event|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
394411|NCT01005251|E3|Reported Event|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
394412|NCT01005251|E2|Reported Event|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
394413|NCT01005251|E1|Reported Event|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
395082|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
394361|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394362|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394363|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394364|NCT01005316|O1|Outcome|Enrolled|Enrolled participants who died, were transplanted or de-listed.
394365|NCT01005316|O1|Outcome|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
394366|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394367|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394368|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction),
394369|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394370|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394371|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394511|NCT01004822|P7|Participant Flow|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394372|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394373|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394374|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394375|NCT01005316|E3|Reported Event|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394376|NCT01005316|E2|Reported Event|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R))
394377|NCT01005316|E1|Reported Event|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
394378|NCT01005290|B1|Baseline|Randomized Patiens|All patients who were randomized to both treatment sequences
394379|NCT01005290|P3|Participant Flow|Ramipril Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
394380|NCT01005290|P2|Participant Flow|Combination Pill Then Ramipril|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks
394381|NCT01005290|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg once daily
394382|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
394383|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
394384|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
394385|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h systolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
394386|NCT01005290|E2|Reported Event|Ramipril|
394387|NCT01005290|E1|Reported Event|Combination Pill|
394388|NCT01005251|B6|Baseline|Total|Total of all reporting groups
394389|NCT01005251|B5|Baseline|Placebo|PPI+Placebo
394390|NCT01005251|B4|Baseline|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
394391|NCT01005251|B3|Baseline|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
394414|NCT01004991|B1|Baseline|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
394415|NCT01004991|P1|Participant Flow|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
394416|NCT01004991|O1|Outcome|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
394417|NCT01004991|E1|Reported Event|All Patients|all study patients
394418|NCT01004939|B1|Baseline|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394419|NCT01004939|P1|Participant Flow|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394420|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394421|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394422|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394423|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394424|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394425|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394426|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394427|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394428|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394429|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394430|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394431|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
395083|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
394432|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394433|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394434|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394435|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394436|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394437|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394438|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
394439|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
394440|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
394441|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
394442|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
394443|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
394444|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394445|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394446|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394447|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394448|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
395084|NCT01002742|E2|Reported Event|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
394449|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394450|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394451|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394452|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394453|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394454|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394455|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394456|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
394457|NCT01004939|E2|Reported Event|Fondaparinux - Child|Events reported for children (including 4 twins) born to mothers receiving Fondaparinux
394458|NCT01004939|E1|Reported Event|Fondaparinux - Mother|Events reported for mothers receiving Fondaparinux
394459|NCT01004874|B1|Baseline|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394460|NCT01004874|P1|Participant Flow|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394461|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394462|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394463|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394464|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394512|NCT01004822|P6|Participant Flow|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
395085|NCT01002742|E1|Reported Event|Placebo|Corticosteroids with placebo
394465|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394466|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394467|NCT01004874|E1|Reported Event|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
394468|NCT01004848|B3|Baseline|Total|Total of all reporting groups
394469|NCT01004848|B2|Baseline|Delayed Intervention|The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394470|NCT01004848|B1|Baseline|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aimed to help participants lose weight, thereby preventing their progression to diabetes."
394471|NCT01004848|P2|Participant Flow|Delayed Intervention|The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394472|NCT01004848|P1|Participant Flow|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394473|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394474|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394475|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394476|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394477|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394478|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394479|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394480|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394481|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394482|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394483|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394484|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394485|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394636|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394486|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394487|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394488|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394489|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394490|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394491|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394492|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394493|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394494|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394495|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394496|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394497|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394498|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394499|NCT01004848|E2|Reported Event|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
394500|NCT01004848|E1|Reported Event|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
394501|NCT01004822|B9|Baseline|Total|Total of all reporting groups
394502|NCT01004822|B8|Baseline|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394503|NCT01004822|B7|Baseline|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394504|NCT01004822|B6|Baseline|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394505|NCT01004822|B5|Baseline|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394506|NCT01004822|B4|Baseline|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394507|NCT01004822|B3|Baseline|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394508|NCT01004822|B2|Baseline|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394509|NCT01004822|B1|Baseline|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394510|NCT01004822|P8|Participant Flow|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
395086|NCT01002573|B3|Baseline|Total|Total of all reporting groups
394513|NCT01004822|P5|Participant Flow|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394514|NCT01004822|P4|Participant Flow|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394515|NCT01004822|P3|Participant Flow|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394516|NCT01004822|P2|Participant Flow|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394517|NCT01004822|P1|Participant Flow|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394518|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394519|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394520|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394521|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394522|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394523|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394524|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394525|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394526|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394527|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394528|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394529|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394530|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394531|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394532|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394533|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394534|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394535|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394536|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394537|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394538|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394539|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394540|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394541|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394542|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394543|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394544|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394545|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394546|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394547|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394548|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394549|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394550|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394551|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394552|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394553|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394554|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394555|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394556|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394557|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394558|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394559|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394560|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394561|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394562|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394563|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394564|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394565|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394566|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394567|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394568|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394569|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394570|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394571|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394572|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
395087|NCT01002573|B2|Baseline|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
394573|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394574|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394575|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394576|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394577|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394578|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394579|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394580|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394581|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394582|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394583|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394584|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394585|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394586|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394587|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394588|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394589|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394590|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394591|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394592|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394593|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394594|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394595|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394596|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394597|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394598|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394599|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394600|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394601|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394602|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
408543|NCT00975637|P3|Participant Flow|280 mg|AMG 827: 280 mg SC
394603|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394604|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394605|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394606|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394607|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394608|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394609|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394610|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394611|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394612|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394613|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394614|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394615|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394616|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394617|NCT01004822|E8|Reported Event|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394618|NCT01004822|E7|Reported Event|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394619|NCT01004822|E6|Reported Event|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394620|NCT01004822|E5|Reported Event|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394621|NCT01004822|E4|Reported Event|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394622|NCT01004822|E3|Reported Event|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394623|NCT01004822|E2|Reported Event|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394624|NCT01004822|E1|Reported Event|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
394625|NCT01004770|B6|Baseline|Total|Total of all reporting groups
394626|NCT01004770|B5|Baseline|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394627|NCT01004770|B4|Baseline|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394628|NCT01004770|B3|Baseline|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394629|NCT01004770|B2|Baseline|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394630|NCT01004770|B1|Baseline|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394631|NCT01004770|P5|Participant Flow|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394632|NCT01004770|P4|Participant Flow|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394633|NCT01004770|P3|Participant Flow|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394634|NCT01004770|P2|Participant Flow|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394635|NCT01004770|P1|Participant Flow|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394637|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394638|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394639|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394640|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394641|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394642|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394643|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394644|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394645|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394646|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394647|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394648|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394649|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394650|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394651|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394652|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394653|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394654|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394655|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394656|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394657|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394658|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394659|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394660|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394661|NCT01004770|E5|Reported Event|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
394662|NCT01004770|E4|Reported Event|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
394663|NCT01004770|E3|Reported Event|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
394664|NCT01004770|E2|Reported Event|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
394665|NCT01004770|E1|Reported Event|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
394666|NCT01004705|B1|Baseline|Randomized Patients|All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)
394667|NCT01004705|P3|Participant Flow|Simvastatin Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks.
394668|NCT01004705|P2|Participant Flow|Combination Pill Then Simvastatin|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks
394669|NCT01004705|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
394670|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
394671|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
394672|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
395088|NCT01002573|B1|Baseline|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
394673|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
394674|NCT01004705|E3|Reported Event|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
394675|NCT01004705|E2|Reported Event|Combination Pill|Combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks
394676|NCT01004705|E1|Reported Event|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
394677|NCT01004614|B5|Baseline|Total|Total of all reporting groups
394678|NCT01004614|B4|Baseline|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
394679|NCT01004614|B3|Baseline|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
394680|NCT01004614|B2|Baseline|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
394681|NCT01004614|B1|Baseline|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods.
394682|NCT01004614|P4|Participant Flow|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
394683|NCT01004614|P3|Participant Flow|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
394684|NCT01004614|P2|Participant Flow|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
394685|NCT01004614|P1|Participant Flow|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods.
394686|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394687|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
394688|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394689|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394690|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394691|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
394692|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394693|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394694|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394695|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
394696|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394697|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394698|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394699|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
394700|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394701|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394702|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394703|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
395204|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
394704|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394705|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394706|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394707|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
394708|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394709|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394710|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394711|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
394712|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394713|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394714|NCT01004614|E4|Reported Event|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
394715|NCT01004614|E3|Reported Event|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
394716|NCT01004614|E2|Reported Event|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
394717|NCT01004614|E1|Reported Event|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
394718|NCT01004510|B1|Baseline|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
394719|NCT01004510|P1|Participant Flow|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.
394720|NCT01004510|O1|Outcome|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
394721|NCT01004510|E1|Reported Event|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
394722|NCT01004432|B1|Baseline|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
394723|NCT01004432|P5|Participant Flow|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
394724|NCT01004432|P4|Participant Flow|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
394725|NCT01004432|P3|Participant Flow|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
394726|NCT01004432|P2|Participant Flow|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
394727|NCT01004432|P1|Participant Flow|Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
394728|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
394729|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
394730|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
394731|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
394732|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
394733|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
394734|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
394921|NCT01003275|B1|Baseline|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
394735|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
394736|NCT01004432|O2|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
394737|NCT01004432|O1|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
394738|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
394739|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
394740|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
394741|NCT01004432|E5|Reported Event|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
394742|NCT01004432|E4|Reported Event|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
394743|NCT01004432|E3|Reported Event|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
394744|NCT01004432|E2|Reported Event|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
394745|NCT01004432|E1|Reported Event|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
394746|NCT01004393|B1|Baseline|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394747|NCT01004393|P1|Participant Flow|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394748|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394749|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394750|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394751|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394752|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394753|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394754|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394755|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394756|NCT01004393|E1|Reported Event|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
394757|NCT01004354|B1|Baseline|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394991|NCT01003106|B5|Baseline|Total|Total of all reporting groups
408544|NCT00975637|P2|Participant Flow|140 mg|AMG 827: 140 mg SC
394758|NCT01004354|P1|Participant Flow|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394759|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394760|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394761|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394762|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394763|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394764|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394765|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394766|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394767|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394768|NCT01004354|E1|Reported Event|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
394769|NCT01004263|B1|Baseline|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394770|NCT01004263|P1|Participant Flow|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394771|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394772|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394773|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394774|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394775|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394776|NCT01004263|E1|Reported Event|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
394777|NCT01004250|B1|Baseline|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394778|NCT01004250|P1|Participant Flow|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394779|NCT01004250|O1|Outcome|Study Treament|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394780|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
395072|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
394781|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394782|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394783|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394784|NCT01004250|E3|Reported Event|Overall Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394785|NCT01004250|E2|Reported Event|Maintenance Therapy|"Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
394786|NCT01004250|E1|Reported Event|Induction Therapy|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
394787|NCT01004185|B3|Baseline|Total|Total of all reporting groups
394788|NCT01004185|B2|Baseline|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
394789|NCT01004185|B1|Baseline|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
394790|NCT01004185|P2|Participant Flow|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
394791|NCT01004185|P1|Participant Flow|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
394792|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
394793|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
394794|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
394795|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
394796|NCT01004185|E2|Reported Event|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
394797|NCT01004185|E1|Reported Event|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
394798|NCT01004172|B1|Baseline|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
394799|NCT01004172|P1|Participant Flow|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
394800|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1"
394823|NCT01004003|B5|Baseline|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
395073|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
394801|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
394802|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
394803|NCT01004172|E1|Reported Event|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
394804|NCT01004159|B1|Baseline|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
394805|NCT01004159|P1|Participant Flow|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
394806|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
394807|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
394808|NCT01004159|E1|Reported Event|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
394809|NCT01004146|B3|Baseline|Total|Total of all reporting groups
394810|NCT01004146|B2|Baseline|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
394811|NCT01004146|B1|Baseline|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
394812|NCT01004146|P2|Participant Flow|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
394813|NCT01004146|P1|Participant Flow|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
394814|NCT01004146|O2|Outcome|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
394815|NCT01004146|O1|Outcome|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
394816|NCT01004146|E2|Reported Event|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
394817|NCT01004146|E1|Reported Event|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
394818|NCT01004003|B10|Baseline|Total|Total of all reporting groups
394819|NCT01004003|B9|Baseline|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394820|NCT01004003|B8|Baseline|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394821|NCT01004003|B7|Baseline|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394822|NCT01004003|B6|Baseline|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394824|NCT01004003|B4|Baseline|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394825|NCT01004003|B3|Baseline|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394826|NCT01004003|B2|Baseline|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394827|NCT01004003|B1|Baseline|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
394828|NCT01004003|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394829|NCT01004003|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394830|NCT01004003|P7|Participant Flow|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394831|NCT01004003|P6|Participant Flow|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394832|NCT01004003|P5|Participant Flow|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394833|NCT01004003|P4|Participant Flow|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394834|NCT01004003|P3|Participant Flow|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394835|NCT01004003|P2|Participant Flow|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394836|NCT01004003|P1|Participant Flow|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
394837|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394838|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394839|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394840|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394841|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394890|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
394842|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394843|NCT01004003|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
394844|NCT01004003|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
394845|NCT01004003|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
394846|NCT01004003|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
394847|NCT01004003|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
394848|NCT01004003|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
394849|NCT01004003|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD).~Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN)."
394850|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394851|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394852|NCT01004003|O2|Outcome|Group 2|Patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394853|NCT01004003|O1|Outcome|Group 1|Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
394854|NCT01004003|E9|Reported Event|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394855|NCT01004003|E8|Reported Event|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394856|NCT01004003|E7|Reported Event|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394857|NCT01004003|E6|Reported Event|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394858|NCT01004003|E5|Reported Event|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394859|NCT01004003|E4|Reported Event|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
394860|NCT01004003|E3|Reported Event|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394861|NCT01004003|E2|Reported Event|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
394891|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
408545|NCT00975637|P1|Participant Flow|210 mg|AMG 827: 210 mg SC
394862|NCT01004003|E1|Reported Event|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
394863|NCT01003990|B4|Baseline|Total|Total of all reporting groups
394864|NCT01003990|B3|Baseline|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
394865|NCT01003990|B2|Baseline|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
394866|NCT01003990|B1|Baseline|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
394867|NCT01003990|P3|Participant Flow|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
394868|NCT01003990|P2|Participant Flow|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
394869|NCT01003990|P1|Participant Flow|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
394870|NCT01003990|O3|Outcome|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
394871|NCT01003990|O2|Outcome|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
394872|NCT01003990|O1|Outcome|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
394873|NCT01003990|E3|Reported Event|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID; Ritonavir: 100 mg BID; Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
394874|NCT01003990|E2|Reported Event|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD; Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
394875|NCT01003990|E1|Reported Event|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
394876|NCT01003938|B1|Baseline|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394877|NCT01003938|P1|Participant Flow|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394878|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394879|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394880|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394881|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394882|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394883|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394884|NCT01003938|E1|Reported Event|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
394885|NCT01003899|B1|Baseline|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
394886|NCT01003899|P1|Participant Flow|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
394887|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
394888|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
394889|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
395074|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
394892|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
394893|NCT01003899|E1|Reported Event|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
394894|NCT01003886|B1|Baseline|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394895|NCT01003886|P1|Participant Flow|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394896|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394897|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394898|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394899|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394900|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394901|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394902|NCT01003886|E1|Reported Event|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
394903|NCT01003301|B3|Baseline|Total|Total of all reporting groups
394904|NCT01003301|B2|Baseline|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394905|NCT01003301|B1|Baseline|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394906|NCT01003301|P2|Participant Flow|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394907|NCT01003301|P1|Participant Flow|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394908|NCT01003301|O2|Outcome|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394909|NCT01003301|O1|Outcome|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394910|NCT01003301|E2|Reported Event|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394911|NCT01003301|E1|Reported Event|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
394912|NCT01003288|B3|Baseline|Total|Total of all reporting groups
394913|NCT01003288|B2|Baseline|Hypogammaglobulinaemic Patients|Received two doses of pandemic vaccine
394914|NCT01003288|B1|Baseline|Health Care Workers|Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional
394915|NCT01003288|P1|Participant Flow|Pandemic Influenza Vaccine (H1N1)v|"Pandemrix: Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A)~* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)"
394916|NCT01003288|O1|Outcome|HCW Pandemic Vaccine|
394917|NCT01003288|O1|Outcome|Pandemic Vaccine|Pandemic Vaccine in HCW
394918|NCT01003288|E1|Reported Event|Pandemic Vaccine|HCW vaccinated with pandemic vaccine
394919|NCT01003275|B3|Baseline|Total|Total of all reporting groups
394920|NCT01003275|B2|Baseline|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
395075|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
394922|NCT01003275|P2|Participant Flow|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
394923|NCT01003275|P1|Participant Flow|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
394924|NCT01003275|O2|Outcome|During Placebo Treatment|
394925|NCT01003275|O1|Outcome|During Paricalcitol Treatment|
394926|NCT01003275|E2|Reported Event|During/After Placebo|
394927|NCT01003275|E1|Reported Event|During/After Paricalcitol|
394928|NCT01003249|B1|Baseline|All Participants|Includes all participants in the study. Participants were randomized to either study drug or placebo
394929|NCT01003249|P2|Participant Flow|Placebo, Then Baclofen|Participants received Placebo for 4 weeks, followed by a 3 week washout period. Participants then received Baclofen for a total of 2 weeks (beginning dose=10mg and dose escalated up to 80 mg as symptoms appear), and were then tapered off of Baclofen for 2 weeks (total time= 4 weeks).
394930|NCT01003249|P1|Participant Flow|Baclofen, Then Placebo|Participants first received Baclofen for a total of 2 weeks (beginning dose=10mg and dose escalated up to 80 mg as symptoms appear), and were then tapered off of Baclofen for 2 weeks (total time= 4 weeks). This was followed by a 3 week washout period and then 4 weeks of Placebo.
394931|NCT01003249|O2|Outcome|Placebo|Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)
394932|NCT01003249|O1|Outcome|Baclofen|Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394933|NCT01003249|O2|Outcome|Placebo|Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)
394934|NCT01003249|O1|Outcome|Baclofen|Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394935|NCT01003249|O2|Outcome|Placebo|Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394936|NCT01003249|O1|Outcome|Baclofen|Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394937|NCT01003249|O2|Outcome|Placebo|Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394938|NCT01003249|O1|Outcome|Baclofen|Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394939|NCT01003249|O2|Outcome|Placebo|Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394940|NCT01003249|O1|Outcome|Baclofen|Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).
394941|NCT01003249|O2|Outcome|Placebo|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
394942|NCT01003249|O1|Outcome|Baclofen|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
394943|NCT01003249|E2|Reported Event|Placebo|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Placebo Comparator: Placebo: Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
394944|NCT01003249|E1|Reported Event|Baclofen|"Subjects will then randomly be assigned in placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen).~Baclofen: Subjects will be randomly assigned to placebo or baclofen groups. Daily dose will be doubled every three days, up to 80 mg or when side effects appear. At the end of 4 week drug will be tapered (halved every 2 days and quitted after 2 days of using 20 mg baclofen)."
394945|NCT01003210|B3|Baseline|Total|Total of all reporting groups
394946|NCT01003210|B2|Baseline|Standard Therapy|standard therapy for otitis media, no ear drops
395076|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
394947|NCT01003210|B1|Baseline|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
394948|NCT01003210|P2|Participant Flow|Standard Therapy|standard therapy for otitis media, no ear drops
394949|NCT01003210|P1|Participant Flow|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
394950|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
394951|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
394952|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
394953|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
394954|NCT01003210|E2|Reported Event|Standard Therapy|standard therapy for otitis media, no ear drops
394955|NCT01003210|E1|Reported Event|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
394956|NCT01003184|B3|Baseline|Total|Total of all reporting groups
394957|NCT01003184|B2|Baseline|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394958|NCT01003184|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394959|NCT01003184|P2|Participant Flow|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394960|NCT01003184|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394961|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394962|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394963|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394964|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394965|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394966|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394967|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394968|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394969|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394970|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394971|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394972|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394973|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394974|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394975|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394976|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394977|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394978|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394979|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394980|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394981|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394982|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394983|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394984|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394985|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394986|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394987|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394988|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394989|NCT01003184|E2|Reported Event|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
394990|NCT01003184|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
394992|NCT01003106|B4|Baseline|CRVO- Ranibizumab 2.0mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~CRVO- Ranibizumab 2.0 mg alone: Central retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
394993|NCT01003106|B3|Baseline|CRVO- Ranibizumab 0.5mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation~CRVO -Ranibizumab 0.5mg alone: Central retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
394994|NCT01003106|B2|Baseline|BRVO- Ranibizumab 2.0mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO- Ranibizumab 2.0 mg alone: Branch retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
394995|NCT01003106|B1|Baseline|BRVO- Ranibizumab 0.5mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO -Ranibizumab 0.5mg alone: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
394996|NCT01003106|P8|Participant Flow|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients randomized to this group at month 6 will receive 0.5mg/2.0mg prn ranibizumab along with laser photocoagulation.
394997|NCT01003106|P7|Participant Flow|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
394998|NCT01003106|P6|Participant Flow|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive ranibizumab 2.0mg alone for 6 months .
394999|NCT01003106|P5|Participant Flow|CRVO- Ranibizumab 0.5mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg at of ranibizumab alone for 6 months.
395000|NCT01003106|P4|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) ranibizumab along with laser photocoagulation.
395001|NCT01003106|P3|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata 0.5mg/2.0mg of ranibizumab without laser photocoagulation.
395002|NCT01003106|P2|Participant Flow|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 2.0mg of Ranibizumab alone for 6 months.
395003|NCT01003106|P1|Participant Flow|BRVO- Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg of ranibizumab alone for 6 months.
395004|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
395005|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
395006|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
395007|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
395008|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
395009|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
395010|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
395011|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
395012|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
395013|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
395014|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
395015|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
395016|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
395017|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
395018|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
395019|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
395020|NCT01003106|O2|Outcome|CRVO|Patients with Central Retinal Vein Occlusion
395021|NCT01003106|O1|Outcome|BRVO|Patients with Branch Retinal Vein Occlusion
395022|NCT01003106|E2|Reported Event|CRVO|Patients with Central Retinal Vein Occlusion
395023|NCT01003106|E1|Reported Event|BRVO|Patients with Branch Retinal Vein Occlusion
395024|NCT01003080|B3|Baseline|Total|Total of all reporting groups
395025|NCT01003080|B2|Baseline|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
395026|NCT01003080|B1|Baseline|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
395027|NCT01003080|P2|Participant Flow|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
395077|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395028|NCT01003080|P1|Participant Flow|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
395029|NCT01003080|O2|Outcome|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
395030|NCT01003080|O1|Outcome|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
395031|NCT01003080|E2|Reported Event|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
395032|NCT01003080|E1|Reported Event|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
395033|NCT01003067|B3|Baseline|Total|Total of all reporting groups
395034|NCT01003067|B2|Baseline|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
395035|NCT01003067|B1|Baseline|No Mesh|The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath).
395036|NCT01003067|P2|Participant Flow|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
395037|NCT01003067|P1|Participant Flow|No Mesh|conventional abdominal closure with a suture
395038|NCT01003067|O2|Outcome|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
395039|NCT01003067|O1|Outcome|No Mesh|conventional abdominal closure with a suture
395040|NCT01003067|E2|Reported Event|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
395041|NCT01003067|E1|Reported Event|No Mesh|conventional abdominal closure with a suture
395042|NCT01002989|B1|Baseline|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
395043|NCT01002989|P1|Participant Flow|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
395044|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
395045|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
395046|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
395047|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
395048|NCT01002989|E1|Reported Event|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
395049|NCT01002742|B3|Baseline|Total|Total of all reporting groups
395050|NCT01002742|B2|Baseline|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395051|NCT01002742|B1|Baseline|Placebo|Corticosteroids with placebo
395052|NCT01002742|P2|Participant Flow|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395053|NCT01002742|P1|Participant Flow|Placebo|Corticosteroids with placebo
395054|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395055|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395056|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395057|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395058|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395059|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395060|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395061|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395062|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395063|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395064|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395065|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395066|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395067|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395068|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395069|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395070|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
395071|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
395089|NCT01002573|P2|Participant Flow|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395090|NCT01002573|P1|Participant Flow|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395091|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395092|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395093|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395094|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395095|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395096|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395097|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395098|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395099|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395100|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395101|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395102|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395103|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395104|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395105|NCT01002573|E2|Reported Event|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
395106|NCT01002573|E1|Reported Event|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
395107|NCT01002482|B3|Baseline|Total|Total of all reporting groups
395108|NCT01002482|B2|Baseline|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395109|NCT01002482|B1|Baseline|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395110|NCT01002482|P2|Participant Flow|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395111|NCT01002482|P1|Participant Flow|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395112|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395113|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395114|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395115|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395116|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395117|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395118|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395119|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395120|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395121|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395122|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395123|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395124|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395125|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395126|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395127|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395128|NCT01002482|E2|Reported Event|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
395129|NCT01002482|E1|Reported Event|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
395130|NCT01002456|B3|Baseline|Total|Total of all reporting groups
395131|NCT01002456|B2|Baseline|Level 2|site- and patient-specific information provided
395132|NCT01002456|B1|Baseline|Level 1|site-specific information provided
395133|NCT01002456|P2|Participant Flow|Arm 2|"provide site- and patient-specific information~Level 2 (Provide site- and patient-specific information): provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions"
395134|NCT01002456|P1|Participant Flow|Arm 1|"provide site-specific information~Level 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline"
395135|NCT01002456|O2|Outcome|Level 2:Provide Site- and Patient-specific Information|Level 2:provide site- and patient-specific information on nonadherence
395136|NCT01002456|O1|Outcome|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on nonadherence
395137|NCT01002456|O2|Outcome|Level 2|provide site- and patient-specific information
395138|NCT01002456|O1|Outcome|Level 1|provide site-specific information
395139|NCT01002456|E2|Reported Event|Level 2: Provide Site- and Patient-specific Information|Level 2: provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
395140|NCT01002456|E1|Reported Event|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on non-adherence
395141|NCT01002339|B4|Baseline|Total|Total of all reporting groups
395142|NCT01002339|B3|Baseline|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395143|NCT01002339|B2|Baseline|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395144|NCT01002339|B1|Baseline|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395145|NCT01002339|P3|Participant Flow|Cyclosporin A (CsA) With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395146|NCT01002339|P2|Participant Flow|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395147|NCT01002339|P1|Participant Flow|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395148|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395149|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395150|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395151|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395152|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395153|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395154|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395205|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
395206|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
395207|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
395208|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
395155|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395156|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395157|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395158|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395159|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395160|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395161|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395162|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395163|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395164|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395165|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395166|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395167|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395168|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395169|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395209|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
395210|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
395170|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395171|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395172|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395173|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395174|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395175|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395176|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395177|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395178|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395179|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395180|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395181|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395182|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395183|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395184|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395211|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
395212|NCT01002287|E2|Reported Event|Control|Good Surgical Technique Alone
395185|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395186|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395187|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395188|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395189|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395190|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395191|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395192|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395193|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395194|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395195|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395196|NCT01002339|E3|Reported Event|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
395197|NCT01002339|E2|Reported Event|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
395198|NCT01002339|E1|Reported Event|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
395199|NCT01002287|B3|Baseline|Total|Total of all reporting groups
395200|NCT01002287|B2|Baseline|Control|Good Surgical Technique Alone
395201|NCT01002287|B1|Baseline|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
395202|NCT01002287|P2|Participant Flow|Control|Good Surgical Technique Alone
395203|NCT01002287|P1|Participant Flow|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
395213|NCT01002287|E1|Reported Event|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
395214|NCT01002118|B1|Baseline|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
395215|NCT01002118|P1|Participant Flow|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
395216|NCT01002118|O1|Outcome|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
395217|NCT01002118|O1|Outcome|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
395218|NCT01002118|O1|Outcome|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
395219|NCT01002118|E1|Reported Event|Omega-3 Fatty Acid|Omega-3 Acid Ethyl Esters: 1 gram capsules for a total of 4 grams (4 capsules) per day for 16 weeks
395220|NCT01002105|B3|Baseline|Total|Total of all reporting groups
395221|NCT01002105|B2|Baseline|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
395222|NCT01002105|B1|Baseline|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
395223|NCT01002105|P2|Participant Flow|Placebo|Placebo, identical to baclofen was administered to the placebo group for 12 weeks
395224|NCT01002105|P1|Participant Flow|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
395225|NCT01002105|O2|Outcome|Placebo|IThe placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations
395226|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
395227|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
395228|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
395229|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
395230|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
395231|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
395232|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
395233|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
395234|NCT01002105|O1|Outcome|Baclofen|The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. Baclofen: Baclofen 50mg per day for 12 weeks
395235|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
395236|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
395237|NCT01002105|E2|Reported Event|Placebo|The placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
395238|NCT01002105|E1|Reported Event|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
395239|NCT01001988|B1|Baseline|Study Group|Participants received a single dose of JE-CV in Study JEC02
395240|NCT01001988|P1|Participant Flow|Study Group|Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
395241|NCT01001988|O1|Outcome|Study Group|Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
395242|NCT01001988|O1|Outcome|Study Group|Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
395243|NCT01001988|E1|Reported Event|Study Group|Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
395244|NCT01001975|B3|Baseline|Total|Total of all reporting groups
395245|NCT01001975|B2|Baseline|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
395246|NCT01001975|B1|Baseline|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
395331|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395247|NCT01001975|P2|Participant Flow|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
395248|NCT01001975|P1|Participant Flow|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
395249|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
395250|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
395251|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
395252|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
395253|NCT01001975|E2|Reported Event|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
395254|NCT01001975|E1|Reported Event|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
395255|NCT01001832|B3|Baseline|Total|Total of all reporting groups
395256|NCT01001832|B2|Baseline|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395257|NCT01001832|B1|Baseline|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395258|NCT01001832|P2|Participant Flow|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395259|NCT01001832|P1|Participant Flow|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395260|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395261|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395262|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395263|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395264|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395332|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395333|NCT01001702|E1|Reported Event|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395334|NCT01001572|B3|Baseline|Total|Total of all reporting groups
395265|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395266|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395267|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395268|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395269|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395270|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395271|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395272|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395273|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395274|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395275|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395276|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395277|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395278|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395335|NCT01001572|B2|Baseline|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
408546|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
395279|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395280|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395281|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395282|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395283|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395284|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395285|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395286|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395287|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395288|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395289|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395290|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395291|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395292|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395336|NCT01001572|B1|Baseline|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395293|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395294|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395295|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
395296|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
395297|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
395298|NCT01001832|E3|Reported Event|Short Term Subcutaneous (SC) Abatacept, 125 mg|Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
395299|NCT01001832|E2|Reported Event|Short Term Intravenous (IV) Abatacept, 125 mg|Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
395300|NCT01001832|E1|Reported Event|Abatacept Long-term (LT) SC 125 mg|Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo). Follow-up was up to 168 days after the last dose of drug.
395301|NCT01001806|B4|Baseline|Total|Total of all reporting groups
395302|NCT01001806|B3|Baseline|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
395303|NCT01001806|B2|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
395304|NCT01001806|B1|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
395305|NCT01001806|P3|Participant Flow|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
395306|NCT01001806|P2|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
395307|NCT01001806|P1|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
395308|NCT01001806|O3|Outcome|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
395309|NCT01001806|O2|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
395310|NCT01001806|O1|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
395311|NCT01001806|E3|Reported Event|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
395312|NCT01001806|E2|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
395313|NCT01001806|E1|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
395314|NCT01001767|B3|Baseline|Total|Total of all reporting groups
395315|NCT01001767|B2|Baseline|Placebo|Placebo capsule by mouth twice a day x 24 weeks
395316|NCT01001767|B1|Baseline|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
395317|NCT01001767|P2|Participant Flow|Placebo|Placebo capsule by mouth twice a day x 24 weeks
395318|NCT01001767|P1|Participant Flow|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
395319|NCT01001767|O2|Outcome|Placebo|Placebo capsule by mouth twice a day x 24 weeks
395320|NCT01001767|O1|Outcome|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
395321|NCT01001767|E2|Reported Event|Placebo|Placebo capsule by mouth twice a day x 24 weeks
395322|NCT01001767|E1|Reported Event|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
395323|NCT01001702|B1|Baseline|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395324|NCT01001702|P1|Participant Flow|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395325|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395326|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395327|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395328|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395329|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395330|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
395337|NCT01001572|P3|Participant Flow|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
395338|NCT01001572|P2|Participant Flow|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395339|NCT01001572|P1|Participant Flow|Single-Blind Run -In Valsartan 160 mg|Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
395340|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
395341|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395342|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
395343|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395344|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
395345|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395346|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
395347|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395348|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
395349|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395350|NCT01001572|E2|Reported Event|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
395351|NCT01001572|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
395352|NCT01001559|B3|Baseline|Total|Total of all reporting groups
395353|NCT01001559|B2|Baseline|Antidepressant Alone|SSRI or SNRI alone
395354|NCT01001559|B1|Baseline|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
395355|NCT01001559|P2|Participant Flow|Antidepressant Alone|SSRI or SNRI alone
395356|NCT01001559|P1|Participant Flow|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
395357|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
395358|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
395359|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
395360|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
395361|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
395362|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
395363|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
395364|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
395365|NCT01001559|E2|Reported Event|Antidepressant Alone|SSRI or SNRI alone
395366|NCT01001559|E1|Reported Event|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
395367|NCT01001546|B3|Baseline|Total|Total of all reporting groups
395368|NCT01001546|B2|Baseline|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
395369|NCT01001546|B1|Baseline|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
395370|NCT01001546|P2|Participant Flow|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
395371|NCT01001546|P1|Participant Flow|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
395372|NCT01001546|O2|Outcome|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
395373|NCT01001546|O1|Outcome|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
395374|NCT01001546|E2|Reported Event|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
395375|NCT01001546|E1|Reported Event|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
395376|NCT01001520|B1|Baseline|Entire Study Population|Includes all subjects who were randomized to both study treatment groups (i.e., receive both placebo first and tolcapone first) and initiated study medication.
395377|NCT01001520|P2|Participant Flow|Tolcapone First, Then Placebo|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took tolcapone during the first medication period, followed by a placebo during the second medication period.~During the active tolcapone medication period, subjects followed a tapered dosing schedule (see protocol section for complete description)."
395378|NCT01001520|P1|Participant Flow|Placebo First, Then Tolcapone|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took placebo during the first medication period, followed by tolcapone during the second medication period.~During the placebo medication period, subjects followed a medication regimen and took capsules that were identical to those in the active tolcapone medication period (see protocol section for complete description)."
395379|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395380|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395381|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395382|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395383|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395384|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395385|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395386|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395387|NCT01001520|O2|Outcome|Tolcapone|"See Protocol or Participant Flow sections for full description of this study arm."
395388|NCT01001520|O1|Outcome|Placebo|"See Protocol or Participant Flow sections for full description of this study arm."
395389|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395390|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395391|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395422|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395423|NCT01001494|E3|Reported Event|Placebo|Placebo via inhalation
395424|NCT01001494|E2|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395392|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395393|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395394|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395395|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395396|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395397|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)"
395398|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
395399|NCT01001520|E2|Reported Event|Tolcapone|"11-day phase, tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily); oral dosing; medication is encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)~Tolcapone: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
395400|NCT01001520|E1|Reported Event|Placebo|"11-day placebo-controlled medication period. Placebo capsules are identical to those in the active tolcapone treatment. When taking placebo, subjects follow an identical dosing schedule as the active treatment period.~Placebo: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
395401|NCT01001494|B4|Baseline|Total|Total of all reporting groups
395402|NCT01001494|B3|Baseline|Placebo|Placebo via inhalation
395403|NCT01001494|B2|Baseline|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395404|NCT01001494|B1|Baseline|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395405|NCT01001494|P3|Participant Flow|Placebo|Placebo via inhalation
395406|NCT01001494|P2|Participant Flow|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395407|NCT01001494|P1|Participant Flow|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395408|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
395409|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395410|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395411|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
395412|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395413|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395414|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
395415|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395416|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395417|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
395418|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395419|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395420|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
395421|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
395425|NCT01001494|E1|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
395426|NCT01001442|B9|Baseline|Total|Total of all reporting groups
395427|NCT01001442|B8|Baseline|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395428|NCT01001442|B7|Baseline|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395429|NCT01001442|B6|Baseline|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395430|NCT01001442|B5|Baseline|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395431|NCT01001442|B4|Baseline|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395432|NCT01001442|B3|Baseline|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395433|NCT01001442|B2|Baseline|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395434|NCT01001442|B1|Baseline|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395435|NCT01001442|P8|Participant Flow|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395436|NCT01001442|P7|Participant Flow|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395437|NCT01001442|P6|Participant Flow|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395438|NCT01001442|P5|Participant Flow|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395439|NCT01001442|P4|Participant Flow|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395440|NCT01001442|P3|Participant Flow|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395441|NCT01001442|P2|Participant Flow|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395442|NCT01001442|P1|Participant Flow|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395443|NCT01001442|O1|Outcome|BT062|BT062: intravenous administration
395444|NCT01001442|O9|Outcome|Total|BT062 administration (all dose levels)
395445|NCT01001442|O8|Outcome|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395446|NCT01001442|O7|Outcome|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395447|NCT01001442|O6|Outcome|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395448|NCT01001442|O5|Outcome|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395449|NCT01001442|O4|Outcome|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395450|NCT01001442|O3|Outcome|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395451|NCT01001442|O2|Outcome|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395452|NCT01001442|O1|Outcome|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395453|NCT01001442|O8|Outcome|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395454|NCT01001442|O7|Outcome|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395455|NCT01001442|O6|Outcome|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395456|NCT01001442|O5|Outcome|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395457|NCT01001442|O4|Outcome|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395458|NCT01001442|O3|Outcome|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395459|NCT01001442|O2|Outcome|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395460|NCT01001442|O1|Outcome|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395461|NCT01001442|O9|Outcome|Total|BT062 Administration (all dose levels)
395462|NCT01001442|O8|Outcome|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395463|NCT01001442|O7|Outcome|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395464|NCT01001442|O6|Outcome|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395465|NCT01001442|O5|Outcome|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395466|NCT01001442|O4|Outcome|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395467|NCT01001442|O3|Outcome|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395468|NCT01001442|O2|Outcome|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395469|NCT01001442|O1|Outcome|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395470|NCT01001442|O1|Outcome|BT062|BT062: intravenous administration
395471|NCT01001442|O9|Outcome|Total|BT062 administration (all dose levels)
395472|NCT01001442|O8|Outcome|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395473|NCT01001442|O7|Outcome|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395474|NCT01001442|O6|Outcome|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
408547|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
395475|NCT01001442|O5|Outcome|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395476|NCT01001442|O4|Outcome|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395477|NCT01001442|O3|Outcome|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395478|NCT01001442|O2|Outcome|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395479|NCT01001442|O1|Outcome|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395480|NCT01001442|E9|Reported Event|Total|BT062 administration (all dose levels)
395481|NCT01001442|E8|Reported Event|BT062 160 mg/m²|160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395482|NCT01001442|E7|Reported Event|BT062 140 mg/m²|140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395483|NCT01001442|E6|Reported Event|BT062 120 mg/m²|120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395484|NCT01001442|E5|Reported Event|BT062 100 mg/m²|100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395485|NCT01001442|E4|Reported Event|BT062 80 mg/m²|80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395486|NCT01001442|E3|Reported Event|BT062 65 mg/m²|65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395487|NCT01001442|E2|Reported Event|BT062 50 mg/m²|50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395488|NCT01001442|E1|Reported Event|BT062 40 mg/m²|40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
395489|NCT01001429|B3|Baseline|Total|Total of all reporting groups
395490|NCT01001429|B2|Baseline|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
395491|NCT01001429|B1|Baseline|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
395492|NCT01001429|P2|Participant Flow|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
395493|NCT01001429|P1|Participant Flow|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
395494|NCT01001429|O2|Outcome|Dexmedetomidine|heart rate recorded at at 30 min intervals while in PACU (2 hours)
395495|NCT01001429|O1|Outcome|Propofol Group|heart rate recorded in 30 min intervals in PACU ( 2 hours)
395496|NCT01001429|O4|Outcome|Dexmedetomidine|diastolic pressure measured every 30 min in PACU
395497|NCT01001429|O3|Outcome|Propofol|diastolic blood pressure recorded every 30 min in PACU
395498|NCT01001429|O2|Outcome|Dexmedetomidine Group|systolic blood pressure measured at 3 0 min. intervals in PACU
395499|NCT01001429|O1|Outcome|Propofol Group|systolic blood pressure at 30 min intervals in PACU
395500|NCT01001429|O2|Outcome|Dexmedetomidine Group|"patient satisfaction~1=very poor, 2=poor, 3=fair, 4= good, 5=excellent"
395501|NCT01001429|O1|Outcome|Propofol|patient satisfaction prior to discharge on a 5 point scale1=very poor, 2=poor, 3=fair, 4= good , 5=excellent
395502|NCT01001429|O2|Outcome|Dexmedetomidine Group|patients receiving study drug dexmedetomidine
395503|NCT01001429|O1|Outcome|Propofol Group|patients receiving comparison drug propofol
395504|NCT01001429|O2|Outcome|Dexmedetomidine Group|surgeon satisfaction at 10 minutes into the procedure
395505|NCT01001429|O1|Outcome|Propofol Group|surgeon satisfaction at 10 minutes in to the procedure for subjects randomized to propofol
395506|NCT01001429|O2|Outcome|Dexmedetomidine|Heart rate recorded at 5 minute interval for subjects randomized to dexmedetomidine
395507|NCT01001429|O1|Outcome|Propofol Group|Heart rate recorded at 5 minute intervals during procedure for subjects randomized to propofol
395508|NCT01001429|O2|Outcome|Dexmedetomidine Group|subjects randomized to dexmedetomidine group had their respiratory rate recorded at 5 minute intervals during the operative procedure
395509|NCT01001429|O1|Outcome|Propofol Group|subjects randomized to propofol group had their respiratory rate recorded at 5 minute intervals during the operative procedure.
395510|NCT01001429|O4|Outcome|Dexmedetomidine Group- Mean Diastolic Blood Pressure|dexmedetomidine as already described and blood pressure monitored 5 min intervals,
395511|NCT01001429|O3|Outcome|Propofol Group- Mean Diastolic Blood Pressure|propofol administered as described- blood pressure recorded at 5 min intervals during surgery
395512|NCT01001429|O2|Outcome|Dexmedetomidine Group-mean Systolic Blood Pressure|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
395513|NCT01001429|O1|Outcome|Propofol Group -Mean Systolic Blood Pressure|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
395514|NCT01001429|O2|Outcome|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
395515|NCT01001429|O1|Outcome|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
395516|NCT01001429|O4|Outcome|UMSS in Dexmedetomidine Infusion Group|subject received medication as described in BIS/dexmedetomidine
395517|NCT01001429|O3|Outcome|UMSS Scores in Propofol Infusion Group|Propofol medication administered as described in BIS group/Propofol group
395984|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395518|NCT01001429|O2|Outcome|BIS Scores in Dexmedetomidine Infusion Group|"Subject will receive a bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
395519|NCT01001429|O1|Outcome|BIS Scores in Propofol Infusion Group|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
395520|NCT01001429|E2|Reported Event|Dexmedetomidine Infusion|"Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.~Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug"
395521|NCT01001429|E1|Reported Event|Propofol|"propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min~propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min"
395522|NCT01001403|B3|Baseline|Total|Total of all reporting groups
395523|NCT01001403|B2|Baseline|Control|
395524|NCT01001403|B1|Baseline|Nafamostat|
395525|NCT01001403|P2|Participant Flow|Control|
395526|NCT01001403|P1|Participant Flow|Nafamostat|
395527|NCT01001403|O2|Outcome|Control|
395528|NCT01001403|O1|Outcome|Nafamostat|
395529|NCT01001403|E2|Reported Event|Control|
395530|NCT01001403|E1|Reported Event|Nafamostat|
395531|NCT01001390|B1|Baseline|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
395532|NCT01001390|P2|Participant Flow|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
395533|NCT01001390|P1|Participant Flow|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
395534|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
395535|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
395536|NCT01001390|E2|Reported Event|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
395537|NCT01001390|E1|Reported Event|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
395538|NCT01001377|B3|Baseline|Total|Total of all reporting groups
395539|NCT01001377|B2|Baseline|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395540|NCT01001377|B1|Baseline|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395541|NCT01001377|P2|Participant Flow|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395542|NCT01001377|P1|Participant Flow|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395543|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395544|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395545|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395546|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395547|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395548|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395549|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395550|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395551|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395552|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395553|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395554|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395555|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395556|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395557|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395558|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395559|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395560|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395561|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395562|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395563|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395564|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395565|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395566|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395567|NCT01001377|E2|Reported Event|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
395568|NCT01001377|E1|Reported Event|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
395569|NCT01001325|B3|Baseline|Total|Total of all reporting groups
395570|NCT01001325|B2|Baseline|Placebo|0.5 mL normal saline
395571|NCT01001325|B1|Baseline|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
395572|NCT01001325|P2|Participant Flow|Placebo|0.5 mL normal saline
395573|NCT01001325|P1|Participant Flow|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
395574|NCT01001325|O2|Outcome|Placebo|0.5 mL normal saline
395575|NCT01001325|O1|Outcome|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
395576|NCT01001325|E2|Reported Event|Placebo|0.5 mL normal saline
395577|NCT01001325|E1|Reported Event|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
395578|NCT01001299|B1|Baseline|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395579|NCT01001299|P1|Participant Flow|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 milligrams [mg] tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 milligrams per kilogram [mg/kg] syrup) on Day 1, followed by 5-day washout. Vemurafenib (RO5185426) 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395580|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395581|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395582|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395583|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395584|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395585|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395586|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395587|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395588|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395589|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395590|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395591|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395592|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395593|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395594|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395595|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395637|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395970|NCT01001104|O1|Outcome|LY 0.25 mg|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
408548|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
395596|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395597|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395598|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395599|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395600|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395601|NCT01001299|E1|Reported Event|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
395602|NCT01001234|B6|Baseline|Total|Total of all reporting groups
395603|NCT01001234|B5|Baseline|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
395604|NCT01001234|B4|Baseline|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
395605|NCT01001234|B3|Baseline|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
395606|NCT01001234|B2|Baseline|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
395607|NCT01001234|B1|Baseline|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
395608|NCT01001234|P5|Participant Flow|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
395638|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395971|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395609|NCT01001234|P4|Participant Flow|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
395610|NCT01001234|P3|Participant Flow|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
395611|NCT01001234|P2|Participant Flow|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
395612|NCT01001234|P1|Participant Flow|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
395613|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
395614|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
395615|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
395616|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
395617|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
395618|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
395619|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
395620|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
395621|NCT01001234|E2|Reported Event|Placebo|Participants who took only placebo during the study
395622|NCT01001234|E1|Reported Event|Rizatriptan|Participants who took any rizatriptan during the study (Stage 1 or 2)
395623|NCT01001221|B5|Baseline|Total|Total of all reporting groups
395624|NCT01001221|B4|Baseline|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395625|NCT01001221|B3|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395626|NCT01001221|B2|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395627|NCT01001221|B1|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395628|NCT01001221|P5|Participant Flow|Part 2: Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the Maximum Tolerated Dose (MTD) as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395629|NCT01001221|P4|Participant Flow|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395630|NCT01001221|P3|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395631|NCT01001221|P2|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395632|NCT01001221|P1|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395633|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395634|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395635|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395636|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395972|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395973|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395639|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395640|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395641|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395642|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395643|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395644|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395645|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395646|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395647|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395648|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395649|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395650|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395651|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395652|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395653|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395654|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395655|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395656|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395657|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395658|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395659|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395660|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395661|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395842|NCT01001195|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395662|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395663|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395664|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395665|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395666|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395667|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395668|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395669|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395670|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395671|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395672|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395673|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395674|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395675|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395676|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395677|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395678|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395679|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395680|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395681|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395682|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395683|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395684|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395843|NCT01001195|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395685|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395686|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395687|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395688|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395689|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395690|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395691|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395692|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395693|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395694|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395695|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395696|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395697|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395698|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395699|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395700|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395701|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395702|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395703|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395704|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395705|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395706|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395707|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395844|NCT01001195|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395708|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395709|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395710|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395711|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395712|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395713|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395714|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395715|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395716|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395717|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395718|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395719|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395720|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395721|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395722|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395723|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395724|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395725|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395726|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395727|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395728|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395729|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395730|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395845|NCT01001195|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395731|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395732|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395733|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395734|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395735|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395736|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395737|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395738|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395739|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395740|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395741|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395742|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395743|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395744|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395745|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395746|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395747|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395748|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395749|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395750|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395751|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395752|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395753|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395846|NCT01001195|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395754|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395755|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395756|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395757|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395758|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395759|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395760|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395761|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395762|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395763|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395764|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395765|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395766|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395767|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395768|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395769|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395770|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395771|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395772|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395773|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395774|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395775|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395776|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395847|NCT01001195|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395777|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395778|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395779|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395780|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395781|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395782|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395783|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395784|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395785|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395786|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395787|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395788|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395789|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395790|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395791|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395792|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395793|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395794|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395795|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395796|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395797|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395798|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395799|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395848|NCT01001169|B3|Baseline|Total|Total of all reporting groups
395974|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395800|NCT01001221|E4|Reported Event|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395801|NCT01001221|E3|Reported Event|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395802|NCT01001221|E2|Reported Event|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395803|NCT01001221|E1|Reported Event|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
395804|NCT01001208|B3|Baseline|Total|Total of all reporting groups
395805|NCT01001208|B2|Baseline|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395806|NCT01001208|B1|Baseline|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395807|NCT01001208|P2|Participant Flow|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395808|NCT01001208|P1|Participant Flow|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395809|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395810|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395811|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395812|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395813|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395814|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395815|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395816|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395817|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395818|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395819|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395975|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395820|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395821|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395822|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395823|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395824|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395825|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395826|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395827|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395828|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395829|NCT01001208|E2|Reported Event|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
395830|NCT01001208|E1|Reported Event|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
395831|NCT01001195|B5|Baseline|Total|Total of all reporting groups
395832|NCT01001195|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395833|NCT01001195|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395834|NCT01001195|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395835|NCT01001195|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395836|NCT01001195|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395837|NCT01001195|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395838|NCT01001195|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395839|NCT01001195|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395840|NCT01001195|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395841|NCT01001195|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
395976|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395977|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395849|NCT01001169|B2|Baseline|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395850|NCT01001169|B1|Baseline|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395851|NCT01001169|P2|Participant Flow|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395852|NCT01001169|P1|Participant Flow|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395853|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395854|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395855|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395856|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395857|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395858|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395859|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395860|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395861|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395862|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395863|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395864|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395865|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395866|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395867|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395978|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395979|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395980|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395868|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395869|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395870|NCT01001169|O1|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395871|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395872|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395873|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395874|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395875|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395876|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395877|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395878|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395879|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395880|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395881|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395882|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395883|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395884|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395885|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395981|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395982|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395886|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395887|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395888|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395889|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395890|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395891|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395892|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395893|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395894|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395895|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395896|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395897|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395898|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395899|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395900|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395901|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395902|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395903|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395983|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395904|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395905|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395906|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395907|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395908|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395909|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395910|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395911|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395912|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395913|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395914|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395915|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395916|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395917|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395918|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395919|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395920|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395921|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395940|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
408549|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
395922|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395923|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395924|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395925|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395926|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395927|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395928|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395929|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395930|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395931|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395932|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395933|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395934|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395935|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395936|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395937|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395938|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
395939|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395941|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
408550|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
395942|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395943|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395944|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395945|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395946|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395947|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395948|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395949|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395950|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395951|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395952|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395953|NCT01001169|E2|Reported Event|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
395954|NCT01001169|E1|Reported Event|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
395955|NCT01001104|B5|Baseline|Total|Total of all reporting groups
395956|NCT01001104|B4|Baseline|Placebo|Administered by SC injection, QW for 12 weeks.
395957|NCT01001104|B3|Baseline|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395958|NCT01001104|B2|Baseline|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395959|NCT01001104|B1|Baseline|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395960|NCT01001104|P4|Participant Flow|Placebo|Administered by SC injection, QW for 12 weeks.
395961|NCT01001104|P3|Participant Flow|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395962|NCT01001104|P2|Participant Flow|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395963|NCT01001104|P1|Participant Flow|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395964|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395965|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395966|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395967|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395968|NCT01001104|O3|Outcome|LY 0.75 mg|Administered by SC injection, QW for 12 weeks.
395969|NCT01001104|O2|Outcome|LY 0.50 mg|Administered by SC injection, QW for 12 weeks.
395985|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395986|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395987|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395988|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395989|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395990|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395991|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395992|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395993|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395994|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395995|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
395996|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395997|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
395998|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
395999|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
396000|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
396001|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
396002|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
396003|NCT01001104|E4|Reported Event|0.75 mg LY2189265|Administered by SC injection, QW for 12 weeks.
396004|NCT01001104|E3|Reported Event|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
396005|NCT01001104|E2|Reported Event|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
396006|NCT01001104|E1|Reported Event|Placebo|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
396007|NCT01001078|B3|Baseline|Total|Total of all reporting groups
396008|NCT01001078|B2|Baseline|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
396009|NCT01001078|B1|Baseline|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
396010|NCT01001078|P2|Participant Flow|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
396011|NCT01001078|P1|Participant Flow|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
396012|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
396013|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
396014|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
396015|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
396016|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
396017|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
396018|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
396019|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
396020|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
396021|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
396022|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
396023|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
396024|NCT01001078|E2|Reported Event|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
396025|NCT01001078|E1|Reported Event|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
396173|NCT01000961|E2|Reported Event|Cystagon®|Safety population during treatment periods
408551|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
396026|NCT01001052|B1|Baseline|Colcrys™ - Young Subjects and Colcrys™ - Elderly Subjects|"Colcrys™ (colchicine) - young subjects (18-30 years): All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.~Colcrys™ (colchicine) - Elderly subjects (≥60 years): All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours."
396027|NCT01001052|P2|Participant Flow|Colcrys™ (Colchicine) - Elderly Subjects (>60 Years)|All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396028|NCT01001052|P1|Participant Flow|Colcrys™ (Colchicine) - Young Subjects (18-30 Years)|All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396029|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396030|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396031|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396032|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396033|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396034|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
396035|NCT01001052|E2|Reported Event|Colcrys™ - Elderly Subjects (>60 Years Old)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
396036|NCT01001052|E1|Reported Event|Colcrys™ - Young Subjects (18-30 Years)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
396037|NCT01000987|B4|Baseline|Total|Total of all reporting groups
396038|NCT01000987|B3|Baseline|Placebo|"placebo~placebo: placebo"
396039|NCT01000987|B2|Baseline|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396040|NCT01000987|B1|Baseline|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396041|NCT01000987|P3|Participant Flow|Placebo|"placebo~placebo: placebo"
396042|NCT01000987|P2|Participant Flow|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396043|NCT01000987|P1|Participant Flow|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396044|NCT01000987|O3|Outcome|Placebo|"placebo~placebo: placebo"
396045|NCT01000987|O2|Outcome|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396046|NCT01000987|O1|Outcome|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396047|NCT01000987|E3|Reported Event|Placebo|"placebo~placebo: placebo"
396048|NCT01000987|E2|Reported Event|2 mg/Day Varenicline|"varenicline 2mg/day~varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396049|NCT01000987|E1|Reported Event|1 mg/Day Varenicline|"varenicline 1mg/day~varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645."
396050|NCT01000974|B4|Baseline|Total|Total of all reporting groups
396051|NCT01000974|B3|Baseline|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396052|NCT01000974|B2|Baseline|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396053|NCT01000974|B1|Baseline|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396054|NCT01000974|P3|Participant Flow|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396055|NCT01000974|P2|Participant Flow|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396056|NCT01000974|P1|Participant Flow|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396057|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396058|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396059|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396060|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396061|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396062|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396063|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396064|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396174|NCT01000961|E1|Reported Event|RP103|Safety Population during treatment periods
396065|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396066|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396067|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396068|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396069|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396070|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396071|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396072|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396073|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396074|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396075|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
397072|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
396076|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396077|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396078|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396079|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally
396080|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396081|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396082|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396083|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396084|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396085|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396086|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396175|NCT01000818|B1|Baseline|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
396087|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396088|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396089|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396090|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396091|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396092|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396093|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396094|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396095|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396096|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396097|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396180|NCT01000818|E4|Reported Event|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
396098|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396099|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396100|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396101|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396102|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396103|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396104|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396105|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396106|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396107|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396108|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396235|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396109|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396110|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396111|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396112|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396113|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396114|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396115|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396116|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396117|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396118|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396119|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396176|NCT01000818|P1|Participant Flow|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
396120|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396121|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396122|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396123|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396124|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396125|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396126|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396127|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396128|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396129|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396130|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396177|NCT01000818|O3|Outcome|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
396131|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396132|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396133|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
396134|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396135|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396136|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396137|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396138|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396139|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally
396140|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396141|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
397073|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
396142|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396143|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396144|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396145|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396146|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally
396147|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396148|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396149|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396150|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396151|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396152|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396178|NCT01000818|O2|Outcome|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
396179|NCT01000818|O1|Outcome|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
396153|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396154|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396155|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396156|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396157|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396158|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396159|NCT01000974|E3|Reported Event|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age.
396160|NCT01000974|E2|Reported Event|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396161|NCT01000974|E1|Reported Event|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally.
396162|NCT01000961|B1|Baseline|RP103 and Cystagon® Crossover|Per Protocol Population
396163|NCT01000961|P2|Participant Flow|Cystagon First, Then RP103, Then Cystagon|RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
396164|NCT01000961|P1|Participant Flow|Cystagon First, Then Cystagon, Then RP103|Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
396165|NCT01000961|O2|Outcome|RP103|Per Protocol Population
396166|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
396167|NCT01000961|O2|Outcome|RP103|Per Protocol Population
396168|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
396169|NCT01000961|O2|Outcome|RP103|Per Protocol Population
396170|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
396171|NCT01000961|O2|Outcome|Cystagon®|Per Protocol Population
396172|NCT01000961|O1|Outcome|RP103|Per Protocol Population
396181|NCT01000818|E3|Reported Event|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
396182|NCT01000818|E2|Reported Event|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
396183|NCT01000818|E1|Reported Event|Prestudy|
396184|NCT01000805|B3|Baseline|Total|Total of all reporting groups
396185|NCT01000805|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
396186|NCT01000805|B1|Baseline|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396187|NCT01000805|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
396188|NCT01000805|P1|Participant Flow|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396189|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396190|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396191|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396192|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396193|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396194|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
396195|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396196|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396197|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396198|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396199|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396200|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396201|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396202|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396203|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396204|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396205|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396206|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396207|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396208|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396209|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396210|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396211|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396212|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396213|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396214|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
396215|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
396216|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396217|NCT01000805|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
396218|NCT01000805|E1|Reported Event|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
396219|NCT01000727|B3|Baseline|Total|Total of all reporting groups
396220|NCT01000727|B2|Baseline|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396221|NCT01000727|B1|Baseline|Placebo|Participants were randomized to receive matching placebo once daily.
396222|NCT01000727|P2|Participant Flow|Darapladib 160 mg|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
396223|NCT01000727|P1|Participant Flow|Placebo|Participants were randomized to receive matching placebo once daily.
396224|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396225|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396226|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396227|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396228|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396229|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396230|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396231|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396232|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396233|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396234|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396236|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396237|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396238|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396239|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396240|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396241|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396242|NCT01000727|O2|Outcome|Placebo|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396243|NCT01000727|O1|Outcome|Darapladib 160 mg|Participants were randomized to receive matching placebo once daily.
396244|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396245|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396246|NCT01000727|O2|Outcome|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396247|NCT01000727|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
396248|NCT01000727|E2|Reported Event|Darapladib 160 mg|Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.
396249|NCT01000727|E1|Reported Event|Placebo|Participants were randomized to receive matching placebo once daily.
396250|NCT01000662|B3|Baseline|Total|Total of all reporting groups
396251|NCT01000662|B2|Baseline|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
396252|NCT01000662|B1|Baseline|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
396253|NCT01000662|P2|Participant Flow|ARM 2 Weekly Boost|"Radiation Therapy~15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
396254|NCT01000662|P1|Participant Flow|ARM 1 Daily Boost|"Radiation Therapy~15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed."
396255|NCT01000662|O2|Outcome|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
396256|NCT01000662|O1|Outcome|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
396257|NCT01000662|E2|Reported Event|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
396258|NCT01000662|E1|Reported Event|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
396259|NCT01000649|B5|Baseline|Total|Total of all reporting groups
396260|NCT01000649|B4|Baseline|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396261|NCT01000649|B3|Baseline|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396539|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
396262|NCT01000649|B2|Baseline|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396263|NCT01000649|B1|Baseline|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396264|NCT01000649|P4|Participant Flow|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396265|NCT01000649|P3|Participant Flow|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.The two patients randomized to FE 202158 3.75 ng group were excluded from the efficacy evaluation since meaningful analyses were not possible.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396266|NCT01000649|P2|Participant Flow|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396267|NCT01000649|P1|Participant Flow|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396268|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396269|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396270|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396271|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396272|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396273|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396274|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396275|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396276|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396277|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396278|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396279|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396280|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396281|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396282|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396283|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396284|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396285|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396286|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396287|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396288|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396289|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396290|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396291|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396292|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396293|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396294|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396295|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396296|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396297|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396298|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396299|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396300|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396301|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396302|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396303|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396304|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396305|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396306|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396307|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396308|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396309|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396310|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396311|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396312|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396313|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396314|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396315|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396316|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396317|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396405|NCT01000493|B1|Baseline|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396318|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396319|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396320|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396321|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396322|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396323|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396324|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396325|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396326|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396327|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396328|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396329|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396330|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396331|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396332|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396333|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396334|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396335|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396336|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396337|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396338|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396339|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396340|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
396341|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396342|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396343|NCT01000649|E4|Reported Event|PLCBO|Patients in the arm received a continuous intravenous infusion of isotonic saline up to seven consecutive days.
396344|NCT01000649|E3|Reported Event|FE 202158 3.75|"Patients in the arm received a continuous intravenous infusion of FE 202158 3.75 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396345|NCT01000649|E2|Reported Event|FE 202158 2.5|"Patients in the arm received a continuous intravenous infusion of FE 202158 2.5 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396346|NCT01000649|E1|Reported Event|FE 202158 1.25|"Patients in the arm received a continuous intravenous infusion of FE 202158 1.25 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
396347|NCT01000610|B1|Baseline|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
396348|NCT01000610|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenous (iv) infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (less than or equal to [≤] 10 milligrams per day (mg/day) prednisone or equivalent) or intra-articular corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs) and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone100 mg iv prior to each rituximab infusion.
396349|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
396350|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
396351|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
396352|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
396353|NCT01000610|E1|Reported Event|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
396354|NCT01000506|B5|Baseline|Total|Total of all reporting groups
396355|NCT01000506|B4|Baseline|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396356|NCT01000506|B3|Baseline|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396357|NCT01000506|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396358|NCT01000506|B1|Baseline|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396359|NCT01000506|P4|Participant Flow|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396360|NCT01000506|P3|Participant Flow|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396361|NCT01000506|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396362|NCT01000506|P1|Participant Flow|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396363|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396364|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396365|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396366|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396367|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396540|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
396368|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396369|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396370|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396371|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396372|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396373|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396374|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396375|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396376|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396377|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396378|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396379|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396380|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396381|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396382|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396383|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396384|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396385|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396386|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396387|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396388|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396389|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396390|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396391|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396392|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396393|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396394|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396395|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396396|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396397|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396398|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396399|NCT01000506|E4|Reported Event|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396400|NCT01000506|E3|Reported Event|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396401|NCT01000506|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396402|NCT01000506|E1|Reported Event|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
396403|NCT01000493|B3|Baseline|Total|Total of all reporting groups
396404|NCT01000493|B2|Baseline|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396406|NCT01000493|P2|Participant Flow|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396407|NCT01000493|P1|Participant Flow|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396408|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396409|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396410|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396411|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396412|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396413|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396414|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396415|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396416|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396417|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396418|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396419|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396420|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396421|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396422|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396423|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396424|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396425|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396426|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396427|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396428|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396429|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396430|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396431|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396432|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396433|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396434|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396435|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396436|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396437|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396438|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396439|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396440|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396441|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396442|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396443|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396444|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396445|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
397074|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
396446|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396447|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396448|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396449|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396450|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396451|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396452|NCT01000493|O2|Outcome|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396453|NCT01000493|O1|Outcome|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396454|NCT01000493|E2|Reported Event|Orvepitant 60 mg Once Daily|Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks.
396455|NCT01000493|E1|Reported Event|Placebo|Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks.
396456|NCT01000480|B1|Baseline|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
396457|NCT01000480|P1|Participant Flow|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
396458|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
396459|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
396460|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
396505|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396506|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396461|NCT01000480|E1|Reported Event|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
396462|NCT01000376|B3|Baseline|Total|Total of all reporting groups
396463|NCT01000376|B2|Baseline|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396464|NCT01000376|B1|Baseline|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396465|NCT01000376|P2|Participant Flow|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396466|NCT01000376|P1|Participant Flow|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396467|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396468|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396469|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396470|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396471|NCT01000376|E2|Reported Event|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396472|NCT01000376|E1|Reported Event|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
396473|NCT01000337|B3|Baseline|Total|Total of all reporting groups
396474|NCT01000337|B2|Baseline|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
396475|NCT01000337|B1|Baseline|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
396476|NCT01000337|P2|Participant Flow|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
396477|NCT01000337|P1|Participant Flow|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
396478|NCT01000337|O2|Outcome|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
396534|NCT01000285|O5|Outcome|Patient C (Non-responder) Pre-Therapy|
396479|NCT01000337|O1|Outcome|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
396480|NCT01000337|E2|Reported Event|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
396481|NCT01000337|E1|Reported Event|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
396482|NCT01000324|B1|Baseline|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396483|NCT01000324|P1|Participant Flow|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396484|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
396485|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
396486|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396487|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396488|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396489|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396490|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396491|NCT01000324|E1|Reported Event|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
396492|NCT01000311|B3|Baseline|Total|Total of all reporting groups
396493|NCT01000311|B2|Baseline|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396494|NCT01000311|B1|Baseline|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396495|NCT01000311|P2|Participant Flow|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396496|NCT01000311|P1|Participant Flow|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396497|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396498|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396499|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396500|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396501|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396502|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396503|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396504|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396535|NCT01000285|O4|Outcome|Patient B (Responder) Post-Therapy|
396536|NCT01000285|O3|Outcome|Patient B (Responder) Pre-Therapy|
396507|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396508|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396509|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396510|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396511|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396512|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396513|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396514|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396515|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396516|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396517|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396518|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396519|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396520|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396521|NCT01000311|E2|Reported Event|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
396522|NCT01000311|E1|Reported Event|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
396523|NCT01000285|B3|Baseline|Total|Total of all reporting groups
396524|NCT01000285|B2|Baseline|Lymphoma ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396525|NCT01000285|B1|Baseline|Acute ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396526|NCT01000285|P1|Participant Flow|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396527|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396528|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396529|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
396530|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
396531|NCT01000285|O8|Outcome|Patient D (Non-responder) Post-Therapy|
396532|NCT01000285|O7|Outcome|Patient D (Non-responder) Pre-Therapy|
396533|NCT01000285|O6|Outcome|Patient C (Non-responder) Post-Therapy|
396541|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396542|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396543|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396544|NCT01000285|E1|Reported Event|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
396545|NCT01000155|B1|Baseline|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
396546|NCT01000155|P1|Participant Flow|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
396547|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
396548|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
396549|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
396550|NCT01000155|E1|Reported Event|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
396551|NCT01000064|B1|Baseline|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
396552|NCT01000064|P2|Participant Flow|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
396553|NCT01000064|P1|Participant Flow|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
396554|NCT01000064|O2|Outcome|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
396555|NCT01000064|O1|Outcome|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
396556|NCT01000064|O1|Outcome|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
396557|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396558|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396559|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396560|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396561|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396562|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396563|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396564|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396565|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396566|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396567|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396568|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396569|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396570|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
396571|NCT01000064|E2|Reported Event|Placebo|Placebo capsule Taken for 42 days.
396572|NCT01000064|E1|Reported Event|Vyvanse|Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
396573|NCT01000025|B3|Baseline|Total|Total of all reporting groups
396574|NCT01000025|B2|Baseline|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396575|NCT01000025|B1|Baseline|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396576|NCT01000025|P2|Participant Flow|Placebo|Control arm
396577|NCT01000025|P1|Participant Flow|PF-804|Study treatment arm
396578|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396579|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396580|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396581|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396582|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396583|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396584|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396585|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396586|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396587|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396588|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396589|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396590|NCT01000025|E2|Reported Event|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
396591|NCT01000025|E1|Reported Event|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
396592|NCT00999921|B3|Baseline|Total|Total of all reporting groups
396593|NCT00999921|B2|Baseline|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months
396594|NCT00999921|B1|Baseline|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months
396595|NCT00999921|P2|Participant Flow|Evening Primrose Oil|Evening Primrose Oil 1000 mg daily for 3 months
396596|NCT00999921|P1|Participant Flow|Tamoxifen|Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months
396597|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
396598|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
396599|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
396600|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
396601|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
396602|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
396603|NCT00999921|E2|Reported Event|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
396604|NCT00999921|E1|Reported Event|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
396605|NCT00999908|B1|Baseline|Entire Study Population|The entire study population includes the 3 groups of patients who received indacaterol 150 μg, tiotropium 18 μg, and placebo (matching indacaterol) once each in 1 of 3 different orders in this crossover study. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396606|NCT00999908|P3|Participant Flow|Placebo-indacaterol 150 μg-tiotropium 18 μg|Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396607|NCT00999908|P2|Participant Flow|Tiotropium 18 μg-placebo-indacaterol 150 μg|Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396608|NCT00999908|P1|Participant Flow|Indacaterol 150 μg-tiotropium 18 μg-placebo|Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396609|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396610|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396611|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396612|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396613|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396614|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396615|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396616|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396617|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396618|NCT00999908|E3|Reported Event|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396619|NCT00999908|E2|Reported Event|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396620|NCT00999908|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
396621|NCT00999830|B3|Baseline|Total|Total of all reporting groups
396622|NCT00999830|B2|Baseline|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396623|NCT00999830|B1|Baseline|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396624|NCT00999830|P2|Participant Flow|Arm B: IPH2101 2mg/kg|IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
396625|NCT00999830|P1|Participant Flow|Arm A: IPH2101 0.2mg/Kg|IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
396626|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396627|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396628|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396629|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396630|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396631|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396632|NCT00999830|E2|Reported Event|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396633|NCT00999830|E1|Reported Event|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
396634|NCT00999804|B3|Baseline|Total|Total of all reporting groups
396635|NCT00999804|B2|Baseline|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396636|NCT00999804|B1|Baseline|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396637|NCT00999804|P2|Participant Flow|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396638|NCT00999804|P1|Participant Flow|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396639|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396640|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396641|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396642|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396643|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396644|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396645|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396646|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396647|NCT00999804|E2|Reported Event|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396648|NCT00999804|E1|Reported Event|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
396649|NCT00999713|B3|Baseline|Total|Total of all reporting groups
396650|NCT00999713|B2|Baseline|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
396651|NCT00999713|B1|Baseline|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396652|NCT00999713|P2|Participant Flow|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
396653|NCT00999713|P1|Participant Flow|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396654|NCT00999713|O2|Outcome|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
396655|NCT00999713|O1|Outcome|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396656|NCT00999713|O2|Outcome|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
396657|NCT00999713|O1|Outcome|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396658|NCT00999713|O2|Outcome|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
397075|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
396659|NCT00999713|O1|Outcome|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396660|NCT00999713|O2|Outcome|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
396661|NCT00999713|O1|Outcome|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396662|NCT00999713|O2|Outcome|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
396663|NCT00999713|O1|Outcome|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396664|NCT00999713|E2|Reported Event|Placebo (Air)|"Endotracheal air administration~Air placebo: Endotracheal air administration"
396665|NCT00999713|E1|Reported Event|Calfactant|"Endotracheal calfactant administration~Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies"
396666|NCT00999687|B1|Baseline|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks.
396667|NCT00999687|P1|Participant Flow|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract (INOE) was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and INOE was applied to both hands twice daily for another 12 weeks.
396668|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then transfer to Indigo Naturalis Oil Extract from week 13 to week 24
396669|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
396670|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
396671|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
396672|NCT00999687|E1|Reported Event|All Participants (Indigo Naturalis Oil Extreact/Olive Oil)|"Experimental group: randomized to receive Indigo Naturalis Oil Extract first; Control group: randomized to receive Olive Oil first.~In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks."
396673|NCT00999661|B1|Baseline|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
396674|NCT00999661|P1|Participant Flow|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
396675|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
396676|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
396677|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
396678|NCT00999661|E1|Reported Event|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
396679|NCT00999609|B3|Baseline|Total|Total of all reporting groups
396680|NCT00999609|B2|Baseline|Control|Control group did not receive voretigene neparvovec-rzyl. The control group became eligible to receive voretigene neparvovec-rzyl 1 year after their baseline evaluations, provided they still met all eligibility criteria.
396681|NCT00999609|B1|Baseline|Intervention|Bilateral subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2), 1.5x 10e11 vg in a total volume of 0.3ml per eye, administered no fewer than 6 days apart
396682|NCT00999609|P2|Participant Flow|Control|No intervention, no sham; uninjected control group
396683|NCT00999609|P1|Participant Flow|Intervention|Bilateral subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2), 1.5x 10e11 vg in a total volume of 0.3ml per eye, administered no fewer than 6 days apart
396684|NCT00999609|O2|Outcome|Control|No intervention, no sham; uninjected control group
396685|NCT00999609|O1|Outcome|Intervention|Bilateral, subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2)
396686|NCT00999609|O2|Outcome|Control|No intervention, no sham; uninjected control group
396687|NCT00999609|O1|Outcome|Intervention|Bilateral, subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2)
396688|NCT00999609|O2|Outcome|Control|No intervention, no sham; uninjected control group
396689|NCT00999609|O1|Outcome|Intervention|Bilateral, subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2)
396690|NCT00999609|O2|Outcome|Control|No intervention, no sham; uninjected control group
396691|NCT00999609|O1|Outcome|Intervention|Bilateral, subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2)
396692|NCT00999609|E2|Reported Event|Control|No intervention, no sham; uninjected control group
396693|NCT00999609|E1|Reported Event|Intervention|Bilateral subretinal injection of voretigene neparvovec-rzyl (AAV2-hRPE65v2), 1.5x 10e11 vg in a total volume of 0.3ml per eye, administered no fewer than 6 days apart
396694|NCT00999596|B1|Baseline|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
396695|NCT00999596|P1|Participant Flow|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
396696|NCT00999596|O2|Outcome|FFDM Mammograms Score = Fail|Mammogram sets from the Philips Digital System with Fail score for Image Quality
396697|NCT00999596|O1|Outcome|FFDM Mammograms Score = Pass|Mammogram sets from the Philips Digital System with Pass score for Image Quality
396698|NCT00999596|E1|Reported Event|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
396699|NCT00999544|B1|Baseline|Crossover Within Subject|All subjects were exposed to every condition.
396738|NCT00999466|P1|Participant Flow|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396700|NCT00999544|P1|Participant Flow|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.
396701|NCT00999544|O15|Outcome|Aprepitant 200 mg/ Oxycodone 30 IN 0 PO|"Aprepitant 200 mg/ oxycodone 30 IN 0 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 30mg, IN: Oxycodone 30mg, IN"
396702|NCT00999544|O14|Outcome|Aprepitant 200 mg/ Oxycodone 15 IN 0 PO|"Aprepitant 200 mg/ oxycodone 15 IN 0 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 15mg, IN: Oxycodone 15mg, IN"
396703|NCT00999544|O13|Outcome|Aprepitant 200 mg/ Oxycodone 0 IN 40 PO|"Aprepitant 200 mg/ oxycodone 0 IN 40 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 40mg, p.o.: Oxycodone 40mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396704|NCT00999544|O12|Outcome|Aprepitant 200 mg/ Oxycodone 0 IN 20 PO|"Aprepitant 200 mg/ oxycodone 0 IN 20 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 20mg, p.o.: Oxycodone 20mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396705|NCT00999544|O11|Outcome|Aprepitant 200 mg/ Oxycodone 0 IN 0 PO|"Aprepitant 200 mg/ oxycodone 0 IN 0 PO~Aprepitant 200mg: Aprepitant 200mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396706|NCT00999544|O10|Outcome|Aprepitant 40 mg/ Oxycodone 30 IN 0 PO|"Aprepitant 40 mg/ oxycodone 30 IN 0 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 30mg, IN: Oxycodone 30mg, IN"
396707|NCT00999544|O9|Outcome|Aprepitant 40 mg/ Oxycodone 15 IN 0 PO|"Aprepitant 40 mg/ oxycodone 15 IN 0 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 15mg, IN: Oxycodone 15mg, IN"
396708|NCT00999544|O8|Outcome|Aprepitant 40 mg/ Oxycodone 0 IN 40 PO|"Aprepitant 40 mg/ oxycodone 0 IN 40 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 40mg, p.o.: Oxycodone 40mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396709|NCT00999544|O7|Outcome|Aprepitant 40 mg/ Oxycodone 0 IN 20 PO|"Aprepitant 40 mg/ oxycodone 0 IN 20 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 20mg, p.o.: Oxycodone 20mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396710|NCT00999544|O6|Outcome|Aprepitant 40 mg/ Oxycodone 0 IN 0 PO|"Aprepitant 40 mg/ oxycodone 0 IN 0 PO~Aprepitant 40mg: Aprepitant 40mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396711|NCT00999544|O5|Outcome|Placebo Aprepitant/ Oxycodone 0 IN 40 PO|"Placebo aprepitant/ oxycodone 0 IN 40 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 40mg, p.o.: Oxycodone 40mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396712|NCT00999544|O4|Outcome|Placebo Aprepitant/ Oxycodone 0 IN 20 PO|"Placebo aprepitant/ oxycodone 0 IN 20 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 20mg, p.o.: Oxycodone 20mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396713|NCT00999544|O3|Outcome|Placebo Aprepitant/ Oxycodone 30 IN 0 PO|"Placebo aprepitant/ oxycodone 30 IN 0 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 30mg, IN: Oxycodone 30mg, IN"
396714|NCT00999544|O2|Outcome|Placebo Aprepitant/ Oxycodone 15 IN 0 PO|"Placebo aprepitant/ oxycodone 15 IN 0 PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 15mg, IN: Oxycodone 15mg, IN"
396715|NCT00999544|O1|Outcome|Placebo Aprepitant/0 mg Oxycodone IN PO|"Placebo aprepitant/Placebo oxycodone IN/PO~Aprepitant 0mg: Aprepitant 0mg, p.o. pretreatment~Oxycodone 0mg, p.o.: Oxycodone 0mg, p.o.~Oxycodone 0mg, IN: Oxycodone 0mg, IN"
396716|NCT00999544|O15|Outcome|Aprepitant 200 mg- 40 Oxycodone Oral|All subjects received exposure to this study condition once.
396717|NCT00999544|O14|Outcome|Aprepitant 200 mg- 20 Oxycodone Oral|All subjects received exposure to this study condition once.
396718|NCT00999544|O13|Outcome|Aprepitant 200 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
396719|NCT00999544|O12|Outcome|Aprepitant 200 mg - 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
396720|NCT00999544|O11|Outcome|Aprepitant 40 mg - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
396721|NCT00999544|O10|Outcome|Aprepitant 40 mg- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
396722|NCT00999544|O9|Outcome|Aprepitant 40 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
396723|NCT00999544|O8|Outcome|Aprepitant 40 mg- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
396724|NCT00999544|O7|Outcome|Placebo - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
396725|NCT00999544|O6|Outcome|Placebo- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
396726|NCT00999544|O5|Outcome|Placebo- 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
396727|NCT00999544|O4|Outcome|Placebo- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
396728|NCT00999544|O3|Outcome|Aprepitant 200 mg- Placebo|All subjects received exposure to this study condition once.
396729|NCT00999544|O2|Outcome|Aprepitant 40 mg - Placebo|All subjects received exposure to this study condition once.
396730|NCT00999544|O1|Outcome|Placebo-Placebo (in and po)|All subjects received exposure to this study condition once.
396731|NCT00999544|E1|Reported Event|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. This was not a parallel group design.
396732|NCT00999466|B4|Baseline|Total|Total of all reporting groups
396733|NCT00999466|B3|Baseline|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396734|NCT00999466|B2|Baseline|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396735|NCT00999466|B1|Baseline|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396736|NCT00999466|P3|Participant Flow|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396737|NCT00999466|P2|Participant Flow|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396739|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396740|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396741|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396742|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396743|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396744|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396745|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396746|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396747|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396748|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396749|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396750|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396751|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396752|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396753|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396754|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396755|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396756|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396757|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396758|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396759|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396760|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396761|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396762|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396763|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396764|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396765|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396766|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396767|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396768|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396769|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396770|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396771|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396772|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396773|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396774|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396775|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396776|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396777|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396778|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396779|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396780|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396781|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396782|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396783|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396784|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396785|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396786|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396787|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396788|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396789|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396790|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396791|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396792|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396793|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396794|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396795|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396796|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396797|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396798|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396799|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396800|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396801|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396802|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396803|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396804|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396805|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396806|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396807|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396808|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396809|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396810|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396811|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396812|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396813|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396814|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396815|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396816|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396817|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396818|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396819|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396820|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396821|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396822|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396823|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396824|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396825|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396826|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396827|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396828|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396829|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396830|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396831|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396832|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396833|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396834|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396835|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396836|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396837|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396838|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396839|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396840|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396841|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396842|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396843|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396844|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396845|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396846|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396847|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396848|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396849|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396850|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396851|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396852|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396853|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396854|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396855|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396856|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396857|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396858|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396859|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396860|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396861|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396862|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396863|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396864|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396865|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396866|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396867|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396868|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396869|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396870|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396871|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396872|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396873|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396874|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396875|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396876|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396877|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396878|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396879|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396880|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396881|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396882|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396883|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396884|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396885|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396886|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396887|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396888|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
397049|NCT00999141|O4|Outcome|Moderately Satisfied|
396889|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396890|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396891|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396892|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396893|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396894|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396895|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396896|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396897|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396898|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396899|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396900|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396901|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396902|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396903|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396904|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396905|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396906|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396907|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396908|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396909|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396910|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396911|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396912|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396913|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396914|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396915|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396916|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396917|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396918|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396919|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396920|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396921|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396922|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396923|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396924|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396925|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396926|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396927|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396928|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396929|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396930|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396931|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396932|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396933|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396934|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396935|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396936|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396937|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396938|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396939|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396940|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396941|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396942|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396943|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396944|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396945|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396946|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396947|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396948|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396949|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396950|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396951|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396952|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396953|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396954|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396955|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396956|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396957|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396958|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396959|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396960|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396961|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396962|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396963|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396964|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396965|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396966|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396967|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396968|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396969|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396970|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396971|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396972|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396973|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396974|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396975|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396976|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396977|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396978|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396979|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396980|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396981|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396982|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396983|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396984|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396985|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396986|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396987|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396988|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396989|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396990|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396991|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396992|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396993|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396994|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396995|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396996|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
396997|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
396998|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
396999|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
397000|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
397001|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
397002|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
397003|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
397004|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
397005|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
397006|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
397007|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
397008|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
397009|NCT00999466|E3|Reported Event|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
397010|NCT00999466|E2|Reported Event|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
397011|NCT00999466|E1|Reported Event|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
397012|NCT00999167|B3|Baseline|Total|Total of all reporting groups
397013|NCT00999167|B2|Baseline|Placebo|6 mL BID
397014|NCT00999167|B1|Baseline|HPN-100|6 mL BID
397015|NCT00999167|P3|Participant Flow|Placebo|Subjects will receive 6 mL BID placebo for 16 weeks (Part B)
397016|NCT00999167|P2|Participant Flow|HPN-100 6 mL|Subjects will receive 6 mL BID HPN-100 for 16 weeks (Part B)
397017|NCT00999167|P1|Participant Flow|HPN-100 6 mL and 9 mL|Subjects will undergo a one step dose escalation over 4 weeks. Subjects will initially receive 6 mL HPN-100 BID for 1 week. On Day 7 and following a satisfactory safety assessment of the subject, the dose will be escalated to 9 mL BID for an additional 3 weeks.
397018|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
397019|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
397020|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
397021|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
397022|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
397023|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
397024|NCT00999167|O2|Outcome|Placebo|6 mL BID
397025|NCT00999167|O1|Outcome|HPN-100|6 mL BID
397026|NCT00999167|O1|Outcome|HPN-100 BID|6 mL or 9 mL BID HPN-100 (Part A)
397027|NCT00999167|E3|Reported Event|Part B: Placebo|Matching HPN-100 placebo, 6 mL BID
397028|NCT00999167|E2|Reported Event|Part B: HPN-100|6 mL BID, equivalent to approximately 13.2 grams of HPN-100/day
397029|NCT00999167|E1|Reported Event|Part A: HPN-100|6 mL BID for 7 days followed by 9 mL BID for 21 days, equivalent to approximately 13.2 and 19.8 grams of HPN-100/day, respectively
397030|NCT00999141|B1|Baseline|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
397031|NCT00999141|P1|Participant Flow|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
397032|NCT00999141|O2|Outcome|Related Facial Adverse Events|
397033|NCT00999141|O1|Outcome|Related Non-Facial Adverse Events|
397034|NCT00999141|O4|Outcome|SoC Side - Seroma|
397035|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Seroma|
397036|NCT00999141|O2|Outcome|SoC Side - Hematoma|
397037|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
397038|NCT00999141|O5|Outcome|Confident|
397039|NCT00999141|O4|Outcome|Somewhat Confident|
397040|NCT00999141|O3|Outcome|Neutral|
397041|NCT00999141|O2|Outcome|Not Very Confident|
397042|NCT00999141|O1|Outcome|Not Confident|
397043|NCT00999141|O5|Outcome|Very Satisfied|
397044|NCT00999141|O4|Outcome|Moderately Satisfied|
397045|NCT00999141|O3|Outcome|Somewhat Satisfied|
397046|NCT00999141|O2|Outcome|A Little Satisfied|
397047|NCT00999141|O1|Outcome|Not at All Satisfied|
397048|NCT00999141|O5|Outcome|Very Satisfied|
397076|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
397077|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
397078|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
397079|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
397080|NCT00999141|O3|Outcome|Participants With No Preference|
397081|NCT00999141|O2|Outcome|Participants Preferring SoC|
397082|NCT00999141|O1|Outcome|Participants Preferring FS VH S/D 4 S-apr|
397083|NCT00999141|O2|Outcome|Standard of Care (SoC)|
397084|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|
397085|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
397086|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
397087|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
397088|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
397089|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
397090|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
397091|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
397092|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
397093|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
397094|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
397095|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
397096|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
397097|NCT00999141|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
397098|NCT00999141|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
397099|NCT00999141|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
397100|NCT00999141|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 S-apr Side|
397101|NCT00999141|O2|Outcome|Standard of Care (SoC)|Participants With Hematoma/Seroma on SoC Side
397102|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|Participants With Hematoma/Seroma on FS VH S/D 4 s-apr Side
397103|NCT00999141|O4|Outcome|Standard of Care (SoC) Side - Seroma|
397104|NCT00999141|O3|Outcome|Standard of Care (SoC) Side - Hematoma|
397105|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr Side - Seroma|
397106|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
397107|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr|
397108|NCT00999141|O1|Outcome|Standard of Care (SoC)|
397109|NCT00999141|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
397110|NCT00999141|E2|Reported Event|Localized to FS VH S/D 4 S-apr Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr
397111|NCT00999141|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care (SoC).
397112|NCT00999037|B3|Baseline|Total|Total of all reporting groups
397113|NCT00999037|B2|Baseline|Placebo|Placebo: 1 inert tablet tid x 12 weeks
397114|NCT00999037|B1|Baseline|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
397115|NCT00999037|P2|Participant Flow|Placebo|Placebo (inert tablets): 1 tablet TID with meals for 12 weeks
397116|NCT00999037|P1|Participant Flow|Renvela|Sevelamer Carbonate (Renvela) 800 mg tablets: 1 tablet TID with meals for 12 weeks
397117|NCT00999037|O2|Outcome|Placebo|Placebo: 1 inert tablet tid x 12 weeks
397118|NCT00999037|O1|Outcome|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
397119|NCT00999037|O2|Outcome|Placebo|Placebo: 1 inert tablet tid x 12 weeks
397120|NCT00999037|O1|Outcome|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
397121|NCT00999037|O2|Outcome|Placebo|Placebo (1 inert tablet) PO TID with meals x 12 weeks
397122|NCT00999037|O1|Outcome|Renvela|Sevelamer Carbonate (800 mg tablet) PO TID with meals x 12 weeks
397123|NCT00999037|E2|Reported Event|Placebo|Placebo: 1 inert tablet tid x 12 weeks
397124|NCT00999037|E1|Reported Event|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
397125|NCT00998985|B15|Baseline|Total|Total of all reporting groups
397126|NCT00998985|B14|Baseline|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397127|NCT00998985|B13|Baseline|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397128|NCT00998985|B12|Baseline|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397129|NCT00998985|B11|Baseline|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397130|NCT00998985|B10|Baseline|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397131|NCT00998985|B9|Baseline|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397132|NCT00998985|B8|Baseline|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397133|NCT00998985|B7|Baseline|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397134|NCT00998985|B6|Baseline|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397135|NCT00998985|B5|Baseline|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397136|NCT00998985|B4|Baseline|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397137|NCT00998985|B3|Baseline|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397138|NCT00998985|B2|Baseline|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397139|NCT00998985|B1|Baseline|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397140|NCT00998985|P14|Participant Flow|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397141|NCT00998985|P13|Participant Flow|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397142|NCT00998985|P12|Participant Flow|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397143|NCT00998985|P11|Participant Flow|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397144|NCT00998985|P10|Participant Flow|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397145|NCT00998985|P9|Participant Flow|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397146|NCT00998985|P8|Participant Flow|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397147|NCT00998985|P7|Participant Flow|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397148|NCT00998985|P6|Participant Flow|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397149|NCT00998985|P5|Participant Flow|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397150|NCT00998985|P4|Participant Flow|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397151|NCT00998985|P3|Participant Flow|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397152|NCT00998985|P2|Participant Flow|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397153|NCT00998985|P1|Participant Flow|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397154|NCT00998985|O14|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397155|NCT00998985|O13|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397156|NCT00998985|O12|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397157|NCT00998985|O11|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397158|NCT00998985|O10|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397159|NCT00998985|O9|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397160|NCT00998985|O8|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397161|NCT00998985|O7|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397162|NCT00998985|O6|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397163|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397164|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397165|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397166|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397167|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397168|NCT00998985|O14|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397169|NCT00998985|O13|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397170|NCT00998985|O12|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397171|NCT00998985|O11|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397172|NCT00998985|O10|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397173|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397174|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397175|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397176|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397177|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397178|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397179|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397180|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397181|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397182|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397183|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397184|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397185|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397186|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397187|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397188|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397189|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397190|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397191|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397192|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397193|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397194|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397195|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397196|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397197|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397198|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397199|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397200|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397201|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397202|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397203|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397204|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397205|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397206|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397207|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397208|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397209|NCT00998985|E9|Reported Event|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
397210|NCT00998985|E8|Reported Event|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
397211|NCT00998985|E7|Reported Event|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
397212|NCT00998985|E6|Reported Event|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
397213|NCT00998985|E5|Reported Event|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
397214|NCT00998985|E4|Reported Event|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
397215|NCT00998985|E3|Reported Event|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
397216|NCT00998985|E2|Reported Event|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
397217|NCT00998985|E1|Reported Event|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
397218|NCT00998881|B3|Baseline|Total|Total of all reporting groups
397219|NCT00998881|B2|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397220|NCT00998881|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397221|NCT00998881|P2|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397222|NCT00998881|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397223|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397224|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397225|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397226|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397227|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397228|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397229|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397230|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397231|NCT00998881|E2|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
397232|NCT00998881|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
397233|NCT00998868|B1|Baseline|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
397234|NCT00998868|P1|Participant Flow|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
397235|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
397236|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
397237|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
397238|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
397239|NCT00998868|E1|Reported Event|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
397240|NCT00998764|B3|Baseline|Total|Total of all reporting groups
397241|NCT00998764|B2|Baseline|Bapineuzumab/Bapineuzumab|Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397242|NCT00998764|B1|Baseline|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397243|NCT00998764|P2|Participant Flow|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397244|NCT00998764|P1|Participant Flow|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195.
397245|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397246|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397247|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397248|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397249|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397250|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397251|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397252|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397253|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397254|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397255|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397256|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397257|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397258|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397259|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397260|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397261|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapineuzumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397262|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397263|NCT00998764|E2|Reported Event|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397320|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397264|NCT00998764|E1|Reported Event|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
397265|NCT00998738|B1|Baseline|Overall|
397266|NCT00998738|P1|Participant Flow|Overall|
397267|NCT00998738|O1|Outcome|Overall|
397268|NCT00998738|O1|Outcome|Overall|
397269|NCT00998738|O1|Outcome|Overall|
397270|NCT00998738|O1|Outcome|Overall|
397271|NCT00998738|O1|Outcome|Overall|
397272|NCT00998738|O1|Outcome|Overall|
397273|NCT00998738|O1|Outcome|Overall|
397274|NCT00998738|O1|Outcome|Overall|
397275|NCT00998738|O1|Outcome|Overall|
397276|NCT00998738|E1|Reported Event|Overall|
397277|NCT00998660|B4|Baseline|Total|Total of all reporting groups
397278|NCT00998660|B3|Baseline|Parkinsons Disease Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease.
397279|NCT00998660|B2|Baseline|Essential Tremor Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
397280|NCT00998660|B1|Baseline|Dystonia Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat dystonia.
397281|NCT00998660|P1|Participant Flow|Patients Receiving an Activa RC Implant|Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
397282|NCT00998660|O1|Outcome|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
397283|NCT00998660|E1|Reported Event|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
397284|NCT00998582|B3|Baseline|Total|Total of all reporting groups
397285|NCT00998582|B2|Baseline|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
397286|NCT00998582|B1|Baseline|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
397287|NCT00998582|P2|Participant Flow|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
397288|NCT00998582|P1|Participant Flow|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
397289|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
397290|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
397291|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
397292|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
397293|NCT00998582|E2|Reported Event|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
397294|NCT00998582|E1|Reported Event|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
397295|NCT00998517|B4|Baseline|Total|Total of all reporting groups
397296|NCT00998517|B3|Baseline|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397297|NCT00998517|B2|Baseline|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397298|NCT00998517|B1|Baseline|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397299|NCT00998517|P3|Participant Flow|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397300|NCT00998517|P2|Participant Flow|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397301|NCT00998517|P1|Participant Flow|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397302|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397303|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397304|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397305|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397306|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397307|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397308|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397309|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397310|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397311|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397312|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397313|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397314|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397315|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397316|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397317|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397318|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397319|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397321|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397322|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397323|NCT00998517|E3|Reported Event|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
397324|NCT00998517|E2|Reported Event|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
397325|NCT00998517|E1|Reported Event|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
397326|NCT00998426|B1|Baseline|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose ). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
397327|NCT00998426|P1|Participant Flow|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
397328|NCT00998426|O1|Outcome|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device (GS-POC)and one with a glucose non-specific (GNS-POC) monitoring device; a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
397329|NCT00998426|E2|Reported Event|Chronic Phase|"Study procedures will occur one time at least three (3) months post liver transplant. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~glucose monitoring before and after HepaGam B administration: Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.~HepaGam B (Hepatitis B Immune Globulin (HBIG)): Subjects will be gi"
397330|NCT00998426|E1|Reported Event|Acute Phase|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
397331|NCT00998374|B3|Baseline|Total|Total of all reporting groups
397332|NCT00998374|B2|Baseline|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass
397333|NCT00998374|B1|Baseline|Pyloric-sparing|Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch
397334|NCT00998374|P2|Participant Flow|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)
397335|NCT00998374|P1|Participant Flow|Pyloric-sparing|Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS)
397336|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
397337|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
397338|NCT00998374|O2|Outcome|Non-pyloric|Non-pyloric: RYGB
397339|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
397340|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
397341|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
397342|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric sparing: RYGB
397343|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
397344|NCT00998374|E2|Reported Event|Non-pyloric Sparing|Non-pyloric: RYGB
397345|NCT00998374|E1|Reported Event|Pyloric-sparing|Pyloric: SG & DS
397346|NCT00998335|B3|Baseline|Total|Total of all reporting groups
397406|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397407|NCT00998309|O2|Outcome|Azithromycin-with Non-Drug Therapy|Participants with Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397347|NCT00998335|B2|Baseline|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397348|NCT00998335|B1|Baseline|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397349|NCT00998335|P2|Participant Flow|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397350|NCT00998335|P1|Participant Flow|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397351|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart.~Insulin detemir and pre-meal insulin aspart.: This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner."
397352|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir).~Long-acting bedtime insulin detemir (Levemir): This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397353|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
397354|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397355|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397356|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
397357|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397358|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
397359|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397360|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
397408|NCT00998309|O1|Outcome|Azithromycin -With Non-Drug Therapy|Participants without Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
408552|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
397361|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
397362|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397363|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
397364|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397365|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
397366|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397367|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
397368|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397369|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397370|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
397371|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397372|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
397373|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397374|NCT00998335|O1|Outcome|Insulin Detemir x 3 Months (All Pts Had Liver MRS)|Liver fat by MRS measured after 3 months of insulin.
397409|NCT00998309|O2|Outcome|Azithromycin With Comcomittant Drugs|Participants with Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397410|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397375|NCT00998335|E2|Reported Event|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
397376|NCT00998335|E1|Reported Event|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
397377|NCT00998309|B1|Baseline|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397378|NCT00998309|P1|Participant Flow|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397379|NCT00998309|O2|Outcome|Azithromycin With Pregnancy in Female|Female participants with Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397380|NCT00998309|O1|Outcome|Azithromycin Without Pregnancy in Female|Female participants without Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397381|NCT00998309|O2|Outcome|Azithromycin With Non-drug Therapy|Participants with non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397382|NCT00998309|O1|Outcome|Azithromycin Without Non-drug Therapy|Participants without non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397383|NCT00998309|O2|Outcome|Azithromycin- With Comcomittant Drugs|Participants with comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397384|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397385|NCT00998309|O2|Outcome|Azithromycin-with PATH|Participants with previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397386|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397387|NCT00998309|O2|Outcome|Azithromycin-with Complications|Participants with complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397388|NCT00998309|O1|Outcome|Azithromycin -Without Complications|Participants without complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397389|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397390|NCT00998309|O1|Outcome|Azithromycin -Without Past Medical History|Participants without Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397391|NCT00998309|O2|Outcome|Azithromycin- With Renal Dysfunction|Participants with Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397392|NCT00998309|O1|Outcome|Azithromycin Without Renal Dysfunction|Participants without Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397393|NCT00998309|O2|Outcome|Azithromycin With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397394|NCT00998309|O1|Outcome|Azithromycin Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397395|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397396|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397397|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397398|NCT00998309|O3|Outcome|Azithromycin-Dental, or Oral Surgery Infection|Participants with Dental, or Oral Surgery Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397399|NCT00998309|O2|Outcome|Azithromycin - Sexual Transmitted Infection|"Participants with Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infectionwho took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert."
397400|NCT00998309|O1|Outcome|Azithromycin - Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397401|NCT00998309|O2|Outcome|Azithromycin >=65 Years|Participants >=65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397402|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397403|NCT00998309|O2|Outcome|Azithromycin Female|Female participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397404|NCT00998309|O1|Outcome|Azithromycin Male|Male participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397405|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397411|NCT00998309|O2|Outcome|Azithromycin With PATH|Participants with Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397412|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397413|NCT00998309|O2|Outcome|Azithromycin With Complications|Participants with Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397414|NCT00998309|O1|Outcome|Azithromycin Without Complications|Participants without Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397415|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397416|NCT00998309|O1|Outcome|Azithromycin-without Past Medical History|Participants without Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397417|NCT00998309|O2|Outcome|Azithromycin-with Renal Dysfunction|Participants with Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397418|NCT00998309|O1|Outcome|Azithromycin-without Renal Dysfunction|Participants without Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397419|NCT00998309|O2|Outcome|Azithromycin-with Hepatic Dysfunction|Participants with Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397420|NCT00998309|O1|Outcome|Azithromycin -Without Hepatic Dysfunction|Participants without Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397421|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397422|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|"Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.~, moderate infection, or severe in"
397423|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397424|NCT00998309|O3|Outcome|Aazithromycin-Dental and Oral Surgery Infection|Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397425|NCT00998309|O2|Outcome|Azithromycin-Sexual Transmitted Infection|Participants with Sexual Transmitted Infection (STI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397426|NCT00998309|O1|Outcome|Azithromycin -Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection (SSTI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397427|NCT00998309|O2|Outcome|Azithromycin->=65 Years|Participants>=65 years who took Azithromycin SR as a single dose of 2 g (potency, as azithromycin) with an empty stomach according to Japanese Package Insert.
397428|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants with <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397429|NCT00998309|O2|Outcome|Azithromycin-Female|Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397430|NCT00998309|O1|Outcome|Azithromycin -Male|Male participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397431|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397432|NCT00998309|E1|Reported Event|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
397433|NCT00998296|B12|Baseline|Total|Total of all reporting groups
397434|NCT00998296|B11|Baseline|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397435|NCT00998296|B10|Baseline|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397436|NCT00998296|B9|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397437|NCT00998296|B8|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397438|NCT00998296|B7|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397439|NCT00998296|B6|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397440|NCT00998296|B5|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397441|NCT00998296|B4|Baseline|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397442|NCT00998296|B3|Baseline|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397443|NCT00998296|B2|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397444|NCT00998296|B1|Baseline|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397445|NCT00998296|P11|Participant Flow|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397446|NCT00998296|P10|Participant Flow|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397447|NCT00998296|P9|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397448|NCT00998296|P8|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397449|NCT00998296|P7|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397450|NCT00998296|P6|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397451|NCT00998296|P5|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397452|NCT00998296|P4|Participant Flow|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397453|NCT00998296|P3|Participant Flow|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397454|NCT00998296|P2|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397455|NCT00998296|P1|Participant Flow|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397456|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397457|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397458|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397556|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397459|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397460|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397461|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397462|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397463|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397464|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397465|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397466|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg- Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397467|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg- Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397468|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397469|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397470|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397471|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397472|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397473|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397474|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397475|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397476|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397477|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397478|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397479|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397480|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397481|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397482|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397483|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397484|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397485|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397486|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397487|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397488|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397489|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397490|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
397491|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397492|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397493|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397494|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397495|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397496|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397497|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397498|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397499|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397500|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397501|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397502|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397503|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
397504|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397505|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397506|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397507|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397508|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397509|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
397510|NCT00998296|E11|Reported Event|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d) plus film-coated tablet of Afatinib 30 mg (q.d)). This is a part of the expansion phase which follows on the dose-escalation phase."
397511|NCT00998296|E10|Reported Event|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
397512|NCT00998296|E9|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
397513|NCT00998296|E8|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week
397514|NCT00998296|E7|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
397515|NCT00998296|E6|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
397516|NCT00998296|E5|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
397517|NCT00998296|E4|Reported Event|Nintedanib 200 mg +Afatinib 20 mg - Continuosly|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 20 mg was given continuously once daily (q.d.)
397518|NCT00998296|E3|Reported Event|Nintedanib 200 mg +Afatinib 10 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 10 mg was given continuously once daily (q.d.)
397557|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397519|NCT00998296|E2|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
397520|NCT00998296|E1|Reported Event|Nintedanib 150 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
397521|NCT00998205|B1|Baseline|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
397522|NCT00998205|P1|Participant Flow|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
397523|NCT00998205|O1|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
397524|NCT00998205|O1|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
397525|NCT00998205|E1|Reported Event|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
397526|NCT00998049|B1|Baseline|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397527|NCT00998049|P1|Participant Flow|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397528|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397529|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397530|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397531|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397532|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397533|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397534|NCT00998049|E1|Reported Event|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
397535|NCT00998023|B3|Baseline|Total|Total of all reporting groups
397536|NCT00998023|B2|Baseline|AngioSeal VCD|AngioSeal Vascular Closure Device
397537|NCT00998023|B1|Baseline|Mynx VCD|Mynx Vascular Closure Device
397538|NCT00998023|P2|Participant Flow|AngioSeal VCD|AngioSeal Vascular Closure Device
397539|NCT00998023|P1|Participant Flow|Mynx VCD|Mynx Vascular Closure Device
397540|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
397541|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
397542|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
397543|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
397544|NCT00998023|E2|Reported Event|AngioSeal VCD|AngioSeal Vascular Closure Device
397545|NCT00998023|E1|Reported Event|Mynx VCD|Mynx Vascular Closure Device
397546|NCT00997984|B4|Baseline|Total|Total of all reporting groups
397547|NCT00997984|B3|Baseline|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397548|NCT00997984|B2|Baseline|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397549|NCT00997984|B1|Baseline|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397550|NCT00997984|P3|Participant Flow|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397551|NCT00997984|P2|Participant Flow|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397552|NCT00997984|P1|Participant Flow|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397553|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397554|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397555|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397558|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397559|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397560|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397561|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397562|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397563|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397564|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397565|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397566|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397567|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397568|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397569|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397570|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397571|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397572|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397573|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397574|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397575|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397576|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397577|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397578|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397579|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397580|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397581|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397582|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397583|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397584|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397585|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397586|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397587|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397588|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397589|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397590|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397591|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397592|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397593|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397594|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397595|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397596|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397597|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397598|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397599|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397600|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397601|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397602|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397603|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397604|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397605|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397606|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397607|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397608|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397609|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
397610|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397611|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397612|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397613|NCT00997984|E4|Reported Event|All Active|The combined results of the SPD503 AM and PM groups
397614|NCT00997984|E3|Reported Event|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
397615|NCT00997984|E2|Reported Event|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
397616|NCT00997984|E1|Reported Event|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
397617|NCT00997932|B1|Baseline|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
397618|NCT00997932|P1|Participant Flow|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
397619|NCT00997932|O1|Outcome|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
397620|NCT00997932|E2|Reported Event|No IUD Insertion|Women in this group underwent baseline data collection, stated they would like to enroll and receive an IUD between 10 minutes and 48 hours postpartum. These women were not eligible to receive the IUD due to delivery elsewhere, medical complications in peri-partum period.
397621|NCT00997932|E1|Reported Event|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
397622|NCT00997672|B3|Baseline|Total|Total of all reporting groups
397623|NCT00997672|B2|Baseline|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
397624|NCT00997672|B1|Baseline|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
397625|NCT00997672|P2|Participant Flow|Placebo|Placebo
397626|NCT00997672|P1|Participant Flow|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
397627|NCT00997672|O2|Outcome|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
397628|NCT00997672|O1|Outcome|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
397629|NCT00997672|E2|Reported Event|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
397630|NCT00997672|E1|Reported Event|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
397631|NCT00997620|B3|Baseline|Total|Total of all reporting groups
397632|NCT00997620|B2|Baseline|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397633|NCT00997620|B1|Baseline|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397634|NCT00997620|P2|Participant Flow|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397635|NCT00997620|P1|Participant Flow|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397636|NCT00997620|O2|Outcome|Fluticasone Furoate Nasal Spray|One week placebo nasal spray followed by two weeks fluticasone furoate nasal spray.
397637|NCT00997620|O1|Outcome|Placebo Nasal Spray|One week placebo nasal spray followed by two weeks placebo nasal spray
397638|NCT00997620|O2|Outcome|Fluticasone Furoate Nasal Spray|One week placebo nasal spray followed by two weeks fluticasone furoate nasal spray.
397639|NCT00997620|O1|Outcome|Placebo Nasal Spray|One week placebo nasal spray followed by two weeks placebo nasal spray.
397640|NCT00997620|O2|Outcome|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397641|NCT00997620|O1|Outcome|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397642|NCT00997620|O2|Outcome|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397643|NCT00997620|O1|Outcome|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397644|NCT00997620|O2|Outcome|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397645|NCT00997620|O1|Outcome|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397646|NCT00997620|O2|Outcome|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397647|NCT00997620|O1|Outcome|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397648|NCT00997620|E2|Reported Event|Fluticasone Furoate|"Active treatment~Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397649|NCT00997620|E1|Reported Event|Placebo|"Placebo for comparison~Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo"
397650|NCT00997594|B3|Baseline|Total|Total of all reporting groups
397651|NCT00997594|B2|Baseline|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
397652|NCT00997594|B1|Baseline|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
397653|NCT00997594|P2|Participant Flow|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
397654|NCT00997594|P1|Participant Flow|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
397655|NCT00997594|O2|Outcome|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
397656|NCT00997594|O1|Outcome|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
397657|NCT00997594|E2|Reported Event|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
397658|NCT00997594|E1|Reported Event|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
397659|NCT00997555|B3|Baseline|Total|Total of all reporting groups
397660|NCT00997555|B2|Baseline|Control Group|Standard treatment without scheduled bronchoscopy.
397661|NCT00997555|B1|Baseline|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397662|NCT00997555|P2|Participant Flow|Control Group|Standard treatment without scheduled bronchoscopy.
397663|NCT00997555|P1|Participant Flow|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397664|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
397665|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397666|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
397667|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397668|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
397669|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397670|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
397671|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397672|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
397673|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397674|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
397675|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397676|NCT00997555|E2|Reported Event|Control Group|Standard treatment without scheduled bronchoscopy.
397677|NCT00997555|E1|Reported Event|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
397678|NCT00997516|B3|Baseline|Total|Total of all reporting groups
397679|NCT00997516|B2|Baseline|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397680|NCT00997516|B1|Baseline|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397681|NCT00997516|P2|Participant Flow|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397682|NCT00997516|P1|Participant Flow|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397683|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397684|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397685|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397686|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397687|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397688|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397689|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397690|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397691|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397692|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397693|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397694|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397695|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397696|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397697|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397698|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397699|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397700|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397701|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397702|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397703|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397704|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397705|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397706|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397707|NCT00997516|E2|Reported Event|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
397708|NCT00997516|E1|Reported Event|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
397709|NCT00997503|B1|Baseline|TAXUS Liberté Post-Approval Study Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397710|NCT00997503|P1|Participant Flow|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397711|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397712|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397713|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397714|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397715|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397716|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397717|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397718|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397719|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397720|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397721|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397749|NCT00997438|B4|Baseline|Total|Total of all reporting groups
397750|NCT00997438|B3|Baseline|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397722|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397723|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397724|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397725|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397726|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397727|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397728|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397729|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397730|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397731|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397732|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397733|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397734|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397735|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397736|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397737|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397738|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397739|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397740|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397741|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397742|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397743|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397744|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397745|NCT00997503|O1|Outcome|Medically Treated Diabetic Population|Patients enrolled in the TAXUS Libertē Post-Approval Study with medically treated diabetes.
397746|NCT00997503|O1|Outcome|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397747|NCT00997503|O1|Outcome|TAXUS Libertē Post-Approval Study Enrolled Population|There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
397748|NCT00997503|E1|Reported Event|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
397751|NCT00997438|B2|Baseline|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397752|NCT00997438|B1|Baseline|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397753|NCT00997438|P3|Participant Flow|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397754|NCT00997438|P2|Participant Flow|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397755|NCT00997438|P1|Participant Flow|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397756|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397757|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397758|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397759|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397760|NCT00997438|O2|Outcome|MS - Relapsing Remitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397761|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397762|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397763|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397764|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397765|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397766|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397767|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397768|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397769|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397770|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397771|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397772|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397773|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397774|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397775|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397776|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397777|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397778|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397779|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397780|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397781|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397782|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397783|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397784|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397785|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397786|NCT00997438|E3|Reported Event|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397787|NCT00997438|E2|Reported Event|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397788|NCT00997438|E1|Reported Event|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
397789|NCT00997425|B1|Baseline|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
397790|NCT00997425|P1|Participant Flow|Arm 1 Door Cover; Floor Cover|The interventions were provided in the order door cover, then floor cover and then floor cover followed by door cover. After a baseline of 14 days the first Intervention (14 days) was provided, followed by baseline two for another 14 days followed by a second Intervention (14 days).
397791|NCT00997425|O2|Outcome|Floor Cover|"a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door.-"
399868|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
397792|NCT00997425|O1|Outcome|Door Cover|- a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape
397793|NCT00997425|E1|Reported Event|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
397794|NCT00997373|B3|Baseline|Total|Total of all reporting groups
397795|NCT00997373|B2|Baseline|Control|No letrozole before hysterectomy
397796|NCT00997373|B1|Baseline|Letrozole Arm|Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily.
397797|NCT00997373|P2|Participant Flow|Control|No treatment prior to hysterectomy
397798|NCT00997373|P1|Participant Flow|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
397799|NCT00997373|O2|Outcome|Control|no treatemtn prior to hysterectomy
397800|NCT00997373|O1|Outcome|Letrozole|"letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks"
397801|NCT00997373|E2|Reported Event|Control|No treatment prior to hysterectomy
397802|NCT00997373|E1|Reported Event|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
397803|NCT00997334|B1|Baseline|Erlotinib|Patients receive standard dose of erlotinib 150mg daily with cycle length of 28 days; Patients are treated until disease progression or until unaccepted drug toxicity.
397804|NCT00997334|P1|Participant Flow|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
397805|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
397806|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
397807|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
397808|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
397809|NCT00997334|E1|Reported Event|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
397810|NCT00997321|B3|Baseline|Total|Total of all reporting groups
397811|NCT00997321|B2|Baseline|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
397812|NCT00997321|B1|Baseline|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
397813|NCT00997321|P2|Participant Flow|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
397814|NCT00997321|P1|Participant Flow|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
397815|NCT00997321|O2|Outcome|Ketamine|median depth of sedation by the observers assesment of alertness scale in the ketamine group
397816|NCT00997321|O1|Outcome|Propofol|median depth of sedation by the observers assesment of alertness scale in the propofol group
397817|NCT00997321|O2|Outcome|Ketamine|percentage of subjects reporting pain after the procedure who received ketamine
397818|NCT00997321|O1|Outcome|Propofol|percentage of subjects reporting pain after the procedure who received propofol
397819|NCT00997321|O2|Outcome|Ketamine|time in minutes from the start of the procedure until the return of baseline mental status
397820|NCT00997321|O1|Outcome|Propofol|time in minutes from the start of the procedure until the return of baseline mental status
397821|NCT00997321|O2|Outcome|Ketamine|percentage of participants with respiratory depression
397822|NCT00997321|O1|Outcome|Propofol|percentage of participants with respiratory depression
397823|NCT00997321|E2|Reported Event|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
397824|NCT00997321|E1|Reported Event|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
397825|NCT00997243|B1|Baseline|75 mg/m2 5-azacytidine (Vidaza, AZA) and 600 mg Lintuzumab|5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7 cycle 1 and all subsequent cycles. Lintuzumab 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22 for cycle 1 and 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy for all other subsequent cycles.
397826|NCT00997243|P1|Participant Flow|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397827|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397828|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
398683|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
397829|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397830|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397831|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397832|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397833|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397834|NCT00997243|E1|Reported Event|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
397835|NCT00997204|B3|Baseline|Total|Total of all reporting groups
397836|NCT00997204|B2|Baseline|Naive Patients|Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase
397837|NCT00997204|B1|Baseline|Non-Naive Patients|Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase
397838|NCT00997204|P2|Participant Flow|Non-Naive Subjects/ Self-administration Phase|Subjects who had received treatment for HAE with icatibant in previous clinical trials or had been previously treated with the marketed product Firazyr®, got Treatment of Acute HAE Attack with SC icatibant (30 mg)Self-Administered.
397839|NCT00997204|P1|Participant Flow|Naive Subjects/ Naive Treatment Phase|Patients who had never received icatibant before this phase, got treatment of Acute HAE Attack with SC icatibant (30 mg)Administered at Site by Health Care Provider.
397840|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
397841|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
397842|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
397843|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
397844|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
397845|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|"The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.~3 subjects (of the original 25 enrolled in the naive treatment phase)self-administered icatibant while observed bu HCP, as opposed to having the HCP perform the injection. these data were not included in the naive treatment safety analyses."
397846|NCT00997204|E3|Reported Event|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
397847|NCT00997204|E2|Reported Event|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
397848|NCT00997204|E1|Reported Event|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
397849|NCT00997139|B1|Baseline|Treatment Group|Baseline culture positive for Staphylococcus aureus
397850|NCT00997139|P1|Participant Flow|All Subjects|
397851|NCT00997139|O1|Outcome|MRSA|Subjects with Baseline culture positive for methicillin-resistant Staphylococcus aureus
397852|NCT00997139|O1|Outcome|MSSA|Baseline culture positive for methicillin-susceptible staphylococcus aureus
397853|NCT00997139|O1|Outcome|All Subjects|All subjects enrolled
397854|NCT00997139|E1|Reported Event|All Subjects|
397855|NCT00997126|B3|Baseline|Total|Total of all reporting groups
397856|NCT00997126|B2|Baseline|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
397857|NCT00997126|B1|Baseline|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397858|NCT00997126|P2|Participant Flow|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
397859|NCT00997126|P1|Participant Flow|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397860|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
397861|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397862|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
397863|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397864|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
399869|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
397865|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397866|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
397867|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397868|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
397869|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397870|NCT00997126|E2|Reported Event|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
397871|NCT00997126|E1|Reported Event|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
397872|NCT00997113|B3|Baseline|Total|Total of all reporting groups
397873|NCT00997113|B2|Baseline|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
397874|NCT00997113|B1|Baseline|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
397875|NCT00997113|P2|Participant Flow|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
397876|NCT00997113|P1|Participant Flow|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
397877|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
397878|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
397879|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
397880|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
397881|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
397882|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
397883|NCT00997113|E2|Reported Event|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
397884|NCT00997113|E1|Reported Event|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
397885|NCT00997035|B3|Baseline|Total|Total of all reporting groups
397886|NCT00997035|B2|Baseline|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
397887|NCT00997035|B1|Baseline|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
397888|NCT00997035|P2|Participant Flow|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
397889|NCT00997035|P1|Participant Flow|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
397890|NCT00997035|O2|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
397955|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
398684|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
397891|NCT00997035|O1|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
397892|NCT00997035|O2|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
397893|NCT00997035|O1|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
397894|NCT00997035|O2|Outcome|Oral Placebo|oral placebo plus topical antifungal
397895|NCT00997035|O1|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal
397896|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agent
397897|NCT00997035|O1|Outcome|Oral Voriconazole|Oral voriconazole treated participants
397898|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
397899|NCT00997035|O1|Outcome|Oral Voriconazole|Oral voriconazole treated participants
397900|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
397901|NCT00997035|O1|Outcome|Oral Voriconazole|Oral Voriconazole plus topical antifungal agents
397902|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
397903|NCT00997035|O1|Outcome|Oral Voriconazole|Oral Voriconazole plus topical antifungal agents
397904|NCT00997035|O2|Outcome|Oral Placebo|oral placebo plus topical antifungal agents
397905|NCT00997035|O1|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal agents
397906|NCT00997035|E2|Reported Event|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
397907|NCT00997035|E1|Reported Event|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
397908|NCT00996996|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397909|NCT00996996|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397910|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397911|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
399870|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
397912|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397913|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397914|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397915|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397916|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397917|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397918|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397919|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397920|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397921|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397967|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397922|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397923|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397924|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397925|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397926|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397927|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397928|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397929|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397930|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397931|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397979|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397932|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397933|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397934|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397935|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397936|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397937|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397938|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397939|NCT00996996|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
397940|NCT00996944|B3|Baseline|Total|Total of all reporting groups
397941|NCT00996944|B2|Baseline|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397942|NCT00996944|B1|Baseline|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397943|NCT00996944|P2|Participant Flow|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397944|NCT00996944|P1|Participant Flow|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397945|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397946|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397947|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397948|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397949|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397950|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397951|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397952|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397953|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397954|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
399871|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
397956|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397957|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397958|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397959|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397960|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397961|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397962|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397963|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397964|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397965|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397966|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
398001|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397968|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397969|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397970|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397971|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397972|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397973|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397974|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397975|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397976|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397977|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397978|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
398685|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
408553|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
397980|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397981|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397982|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397983|NCT00996944|E2|Reported Event|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
397984|NCT00996944|E1|Reported Event|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
397985|NCT00996931|B1|Baseline|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
397986|NCT00996931|P1|Participant Flow|Lenalidomide|Six patients will receive oral 2.5 mg daily for 12 weeks
397987|NCT00996931|O1|Outcome|Lenalidomide|oral 25 mg daily for 12 weeks
397988|NCT00996931|O1|Outcome|Lenalidomide|Six subjects received oral 2.5 mg daily for 12 weeks
397989|NCT00996931|E1|Reported Event|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
397990|NCT00996918|B6|Baseline|Total|Total of all reporting groups
397991|NCT00996918|B5|Baseline|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397992|NCT00996918|B4|Baseline|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397993|NCT00996918|B3|Baseline|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397994|NCT00996918|B2|Baseline|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397995|NCT00996918|B1|Baseline|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397996|NCT00996918|P5|Participant Flow|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397997|NCT00996918|P4|Participant Flow|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397998|NCT00996918|P3|Participant Flow|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
397999|NCT00996918|P2|Participant Flow|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398000|NCT00996918|P1|Participant Flow|Placebo/Bapineuzumab 0.5 Milligram/Kilogram(mg/kg)|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398686|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398002|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398003|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398004|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398005|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398006|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398007|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398008|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398009|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398010|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398011|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398012|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398013|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398014|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398015|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398016|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398017|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398018|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398019|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398020|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398021|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398022|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398023|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398024|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398025|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398026|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398027|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
399872|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
398028|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398029|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398030|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398031|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398032|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398033|NCT00996918|O5|Outcome|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398034|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398035|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398036|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398037|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398038|NCT00996918|E5|Reported Event|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398039|NCT00996918|E4|Reported Event|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398040|NCT00996918|E3|Reported Event|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398041|NCT00996918|E2|Reported Event|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398042|NCT00996918|E1|Reported Event|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
398043|NCT00996892|B1|Baseline|All Participants|All participants who received cobimetinib and pictilisib in any dose combination until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398044|NCT00996892|P20|Participant Flow|S2A Expansion: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 2A (S2A) expansion cohort: Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.
398045|NCT00996892|P19|Participant Flow|S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 2 (S2) expansion cohort: Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non–small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).
398046|NCT00996892|P18|Participant Flow|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort DX (S1B CDX): Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398047|NCT00996892|P17|Participant Flow|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort CX (S1B CCX): Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398095|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398048|NCT00996892|P16|Participant Flow|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort BX (S1B CBX): Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398049|NCT00996892|P15|Participant Flow|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort AX (S1B CAX): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398050|NCT00996892|P14|Participant Flow|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort G (S1A CG): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398051|NCT00996892|P13|Participant Flow|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort F (S1A CF): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398052|NCT00996892|P12|Participant Flow|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort E (S1A CE): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398053|NCT00996892|P11|Participant Flow|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort D (S1A CD): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398054|NCT00996892|P10|Participant Flow|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort C (S1A CC): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398055|NCT00996892|P9|Participant Flow|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort B (S1A CB): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398056|NCT00996892|P8|Participant Flow|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort A (S1A CA): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398057|NCT00996892|P7|Participant Flow|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6A (S1 C6A): Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398058|NCT00996892|P6|Participant Flow|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6 (S1 C6): Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398059|NCT00996892|P5|Participant Flow|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1 Cohort 5 (S1 C5): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398060|NCT00996892|P4|Participant Flow|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 4 (S1 C4): Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398061|NCT00996892|P3|Participant Flow|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 3 (S1 C3): Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398062|NCT00996892|P2|Participant Flow|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 2 (S1 C2): Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398113|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398063|NCT00996892|P1|Participant Flow|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 1 (S1 C1): Participants received a single oral dose of pictilisib 80 milligrams (mg) capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398064|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398065|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398066|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398067|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398068|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398069|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398070|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398071|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
398072|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398073|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398074|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398075|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398076|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398077|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398078|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
398096|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
398687|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398079|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398080|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398081|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398082|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398083|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398084|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398085|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398086|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398087|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398088|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398089|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
398090|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398091|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398092|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398093|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398094|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398097|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398098|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398099|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398100|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398101|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398102|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398103|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398104|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398105|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398106|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398107|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
398108|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398109|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398110|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398111|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398112|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398114|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
398115|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398116|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398117|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398118|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398119|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398120|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398121|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398122|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398123|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398124|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398125|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398126|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398127|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398128|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
408554|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
398129|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398130|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398131|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398132|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398133|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398134|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398135|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398136|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398137|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398138|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398139|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398140|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398141|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398142|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398143|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398144|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398145|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398146|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398147|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398148|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398149|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398150|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398151|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398152|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398153|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398154|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398155|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398156|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398157|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398158|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398159|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398160|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398161|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398162|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398163|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398164|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398165|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398166|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398167|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398168|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398169|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398170|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398171|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398172|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398173|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398174|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398175|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398176|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398177|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398178|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398179|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398180|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398181|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398182|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398183|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398184|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398185|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398186|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398187|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398188|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398189|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398190|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398191|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398192|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398193|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398194|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398195|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398196|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398197|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398198|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398199|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398200|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398201|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398202|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398203|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398204|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398205|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398206|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398207|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398208|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398209|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398210|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398211|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398212|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398213|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398688|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398214|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398215|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398216|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398217|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398218|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398219|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398220|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398221|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398222|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398223|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398224|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398225|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398226|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398227|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398228|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398229|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398230|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398231|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
399873|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
398232|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398233|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398234|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398235|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398236|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398237|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398238|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398239|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398240|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398241|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398242|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398243|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398244|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398245|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398246|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398247|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398248|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398249|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398767|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398250|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398251|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398252|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398253|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398254|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398255|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398256|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398257|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398258|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398259|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398260|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398261|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398262|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398263|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398264|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398265|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398266|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398267|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398976|NCT00996632|B2|Baseline|Conventional|Patients were operated by a conventional diatherm knife
398268|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398269|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398270|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398271|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398272|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398273|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398274|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398275|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398276|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398277|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398278|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398279|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398280|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398281|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398282|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398283|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398284|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398285|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398286|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398287|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398288|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398289|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398290|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398291|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398292|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398293|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398294|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398295|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398296|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398297|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398298|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398299|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398300|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398301|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398302|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398689|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398690|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398303|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398304|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398305|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398306|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398307|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398308|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398309|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398310|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398311|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398312|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398313|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398314|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398315|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398316|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398317|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398318|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398319|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398691|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398692|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398320|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398321|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398322|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398323|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398324|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398325|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398326|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398327|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398328|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398329|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398330|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398331|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398332|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398333|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398334|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398335|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398336|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398693|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398694|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398337|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398338|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398339|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398340|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398341|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398342|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398343|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398344|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398345|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398346|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398347|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398348|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398349|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398350|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398351|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398352|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398353|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398354|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
399874|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
398355|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398356|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398357|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398358|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398359|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398360|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398361|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398362|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398363|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398364|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398365|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398366|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398367|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398368|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398369|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398370|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398371|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398372|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398695|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
399875|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
398373|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398374|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398375|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398376|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398377|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398378|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398379|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398380|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398381|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398382|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398383|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398384|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398385|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398386|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398387|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398388|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398389|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398390|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398696|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
399876|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
398391|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398392|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398393|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398394|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398395|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398396|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398397|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398398|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398399|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398400|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398401|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398402|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398403|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398404|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398405|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398406|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398407|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398408|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398697|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
399877|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
398409|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398410|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398411|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398412|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398413|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398414|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398415|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398416|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398417|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398418|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398419|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398420|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398421|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398422|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398423|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398424|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398425|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398426|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398698|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
399878|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
398427|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398428|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398429|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398430|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398431|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398432|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398433|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398434|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398435|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398436|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398437|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398438|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398439|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398440|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398441|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398442|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398443|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398444|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398699|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
399879|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
398445|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398446|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398447|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398448|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398449|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398450|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398451|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398452|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398453|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398454|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398455|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398456|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398457|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398458|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398459|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398460|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398461|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398462|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398700|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
399880|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
398463|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398464|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398465|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398466|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398467|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398468|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398469|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398470|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398471|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398472|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398473|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398474|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398475|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398476|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398477|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398478|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398701|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398702|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398479|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398480|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398481|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398482|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398483|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398484|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398485|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398486|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398487|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398488|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398489|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398490|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398491|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398492|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398703|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398704|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398493|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398494|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398495|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398496|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398497|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398498|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398499|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398500|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398501|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398502|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398503|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398504|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398505|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398506|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398705|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398706|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398507|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398508|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398509|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398510|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398511|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398512|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398513|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398514|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398515|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398516|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398517|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398518|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398519|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398520|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398707|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398708|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398521|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398522|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398523|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398524|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398525|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398526|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398527|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398528|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398529|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398530|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398531|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398532|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398533|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398534|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398709|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398710|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398535|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398536|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398537|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398538|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398539|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398540|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398541|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398542|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398543|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398544|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398545|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398546|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398547|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398548|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398711|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398712|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398549|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398550|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398551|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398552|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398553|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398554|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398555|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398556|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398557|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398558|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398559|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398560|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398561|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398562|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398713|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398714|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398563|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398564|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398565|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398566|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398567|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398568|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398569|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398570|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398571|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398572|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398573|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398574|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398575|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398576|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398715|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398716|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398577|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398578|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398579|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398580|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398581|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398582|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398583|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398584|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398585|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398586|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398587|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398588|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398589|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398590|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398717|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398718|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398591|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398592|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398593|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398594|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398595|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398596|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398597|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398598|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398599|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398600|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398601|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398629|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398602|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398603|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398604|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398605|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398606|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398607|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398608|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398609|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398610|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398611|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398645|NCT00996892|E6|Reported Event|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
408555|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
398612|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398613|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398614|NCT00996892|O1|Outcome|All Participants - Stages 1, 1A, 1B|All participants who received cobimetinib and pictilisib in any dose combination during Stages 1, 1A, and 1B, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398615|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398616|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398617|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398618|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398619|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398620|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398621|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398622|NCT00996892|O11|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398623|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398624|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398625|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398626|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398627|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398628|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398680|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398630|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398631|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398632|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398633|NCT00996892|E18|Reported Event|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398634|NCT00996892|E17|Reported Event|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398635|NCT00996892|E16|Reported Event|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398636|NCT00996892|E15|Reported Event|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398637|NCT00996892|E14|Reported Event|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398638|NCT00996892|E13|Reported Event|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398639|NCT00996892|E12|Reported Event|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398640|NCT00996892|E11|Reported Event|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
398641|NCT00996892|E10|Reported Event|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398642|NCT00996892|E9|Reported Event|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398643|NCT00996892|E8|Reported Event|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398644|NCT00996892|E7|Reported Event|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398681|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398682|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398646|NCT00996892|E5|Reported Event|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398647|NCT00996892|E4|Reported Event|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
398648|NCT00996892|E3|Reported Event|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398649|NCT00996892|E2|Reported Event|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398650|NCT00996892|E1|Reported Event|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
398651|NCT00996840|B6|Baseline|Total|Total of all reporting groups
398652|NCT00996840|B5|Baseline|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398653|NCT00996840|B4|Baseline|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398654|NCT00996840|B3|Baseline|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398655|NCT00996840|B2|Baseline|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398656|NCT00996840|B1|Baseline|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398657|NCT00996840|P5|Participant Flow|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398658|NCT00996840|P4|Participant Flow|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398659|NCT00996840|P3|Participant Flow|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398660|NCT00996840|P2|Participant Flow|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 milligrams (mg), IV infusion over 4h for 3 days
398661|NCT00996840|P1|Participant Flow|Combined Placebo|Eligible participants received matching placebo intravenous (IV) infusion over 4 hours (h) or 24 h for 3 days
398662|NCT00996840|O4|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398663|NCT00996840|O3|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398664|NCT00996840|O2|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398665|NCT00996840|O1|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398666|NCT00996840|O4|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398667|NCT00996840|O3|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398668|NCT00996840|O2|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398669|NCT00996840|O1|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398670|NCT00996840|O4|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398671|NCT00996840|O3|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398672|NCT00996840|O2|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398673|NCT00996840|O1|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398674|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398675|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398676|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398677|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398678|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398679|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398719|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398720|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398721|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398722|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398723|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398724|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398725|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398726|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398727|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398728|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398729|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398730|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398731|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398732|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398733|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398734|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398735|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398736|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398737|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398738|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398739|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398740|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398741|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398742|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398743|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398744|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398745|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398746|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398747|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398748|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398749|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398750|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398751|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398752|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398753|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398754|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398755|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398756|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398757|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398758|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398759|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398760|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398761|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398762|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398763|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398764|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398765|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398766|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398768|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398769|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398770|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398771|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398772|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398773|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398774|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398775|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398776|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398777|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398778|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398779|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398780|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398781|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398782|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398783|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398784|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398785|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398786|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398787|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398788|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398789|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398790|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398791|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398792|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398793|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398794|NCT00996840|O5|Outcome|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398795|NCT00996840|O4|Outcome|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398796|NCT00996840|O3|Outcome|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398797|NCT00996840|O2|Outcome|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398798|NCT00996840|O1|Outcome|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398799|NCT00996840|E5|Reported Event|Cohort 4-SB-681323, 10 mg, 24 h|Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
398800|NCT00996840|E4|Reported Event|Cohort 3-SB-681323, 7.5 mg, 4 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
398801|NCT00996840|E3|Reported Event|Cohort 2-SB-681323, 7.5 mg, 24 h|Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
398802|NCT00996840|E2|Reported Event|Cohort 1-SB-681323, 3 mg, 4 h|Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
398803|NCT00996840|E1|Reported Event|Combined Placebo|Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
398804|NCT00996801|B7|Baseline|Total|Total of all reporting groups
398805|NCT00996801|B6|Baseline|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398806|NCT00996801|B5|Baseline|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398807|NCT00996801|B4|Baseline|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398808|NCT00996801|B3|Baseline|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398809|NCT00996801|B2|Baseline|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398810|NCT00996801|B1|Baseline|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398811|NCT00996801|P6|Participant Flow|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398812|NCT00996801|P5|Participant Flow|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398813|NCT00996801|P4|Participant Flow|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398814|NCT00996801|P3|Participant Flow|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398815|NCT00996801|P2|Participant Flow|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398816|NCT00996801|P1|Participant Flow|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398817|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398818|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
398819|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398820|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398821|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398822|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398823|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398824|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
398825|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398826|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398827|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398828|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398829|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398830|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
398831|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398832|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398833|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398834|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398835|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398836|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398837|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398838|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398839|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398840|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398841|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398842|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398843|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
408556|NCT00975637|E5|Reported Event|Broda 70 mg|AMG 827: 70 mg SC
398844|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398845|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398846|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398847|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398848|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398849|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398850|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398851|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398852|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398853|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398854|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398855|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398856|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398857|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398858|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398859|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398860|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398861|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398862|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398863|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398864|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398865|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398866|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398867|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398868|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398869|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398870|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398871|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398872|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398873|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398874|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398875|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398876|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398877|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398878|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398879|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398880|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398881|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398977|NCT00996632|B1|Baseline|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
398882|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398883|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398884|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398885|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398886|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398887|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398888|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398889|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398890|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398891|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398892|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398893|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398894|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398895|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398896|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398897|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398898|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398899|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398900|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398901|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398902|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398903|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398904|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398905|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
398906|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
398907|NCT00996801|O3|Outcome|MK-5442 7.5mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
398908|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
398909|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
398910|NCT00996801|E6|Reported Event|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398911|NCT00996801|E5|Reported Event|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398912|NCT00996801|E4|Reported Event|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398913|NCT00996801|E3|Reported Event|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398914|NCT00996801|E2|Reported Event|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398915|NCT00996801|E1|Reported Event|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
398916|NCT00996775|B3|Baseline|Total|Total of all reporting groups
398978|NCT00996632|P2|Participant Flow|Conventional|Patients were operated by a conventional diatherm knife
398917|NCT00996775|B2|Baseline|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398918|NCT00996775|B1|Baseline|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398919|NCT00996775|P2|Participant Flow|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398920|NCT00996775|P1|Participant Flow|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398921|NCT00996775|O2|Outcome|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398922|NCT00996775|O1|Outcome|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398923|NCT00996775|E2|Reported Event|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398924|NCT00996775|E1|Reported Event|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
398925|NCT00996736|B3|Baseline|Total|Total of all reporting groups
398926|NCT00996736|B2|Baseline|Topical Voriconazole|
398927|NCT00996736|B1|Baseline|Topical Natamycin|
398928|NCT00996736|P2|Participant Flow|Topical Voriconazole|
398929|NCT00996736|P1|Participant Flow|Topical Natamycin|
398930|NCT00996736|O2|Outcome|Topical Voriconazole|
398931|NCT00996736|O1|Outcome|Topical Natamycin|
398932|NCT00996736|O2|Outcome|Topical Voriconazole|
398933|NCT00996736|O1|Outcome|Topical Natamycin|
398934|NCT00996736|O2|Outcome|Topical Voriconazole|
398935|NCT00996736|O1|Outcome|Topical Natamycin|
398936|NCT00996736|O2|Outcome|Topical Voriconazole|
398937|NCT00996736|O1|Outcome|Topical Natamycin|
398938|NCT00996736|O2|Outcome|Topical Voriconazole|
398939|NCT00996736|O1|Outcome|Topical Natamycin|
398940|NCT00996736|O2|Outcome|Topical Voriconazole|
398941|NCT00996736|O1|Outcome|Topical Natamycin|
398942|NCT00996736|O2|Outcome|Topical Voriconazole|
398943|NCT00996736|O1|Outcome|Topical Natamycin|
398944|NCT00996736|E2|Reported Event|Topical Voriconazole|
398945|NCT00996736|E1|Reported Event|Topical Natamycin|
398946|NCT00996658|B3|Baseline|Total|Total of all reporting groups
398947|NCT00996658|B2|Baseline|Linagliptin 5 mg Tablet|
398948|NCT00996658|B1|Baseline|Placebo Tablet|
398949|NCT00996658|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398950|NCT00996658|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398951|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398952|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398953|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398954|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398955|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398956|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398957|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398958|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398959|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398960|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398961|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398962|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398963|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398964|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398965|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398966|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398967|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398968|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398969|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398970|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398971|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398972|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398973|NCT00996658|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
398974|NCT00996658|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
398975|NCT00996632|B3|Baseline|Total|Total of all reporting groups
408557|NCT00975637|E4|Reported Event|Placebo|Placebo: Placebo SC
398979|NCT00996632|P1|Participant Flow|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
398980|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
398981|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
398982|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
398983|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
398984|NCT00996632|E2|Reported Event|Conventional|Patients were operated by a conventional diatherm knife
398985|NCT00996632|E1|Reported Event|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
398986|NCT00996606|B1|Baseline|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398987|NCT00996606|P1|Participant Flow|Tocilizumab in Active Rheumatoid Arthritis (RA)|Participants with active RA received tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398988|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398989|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398990|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398991|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398992|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398993|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398994|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398995|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398996|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398997|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398998|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
398999|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399000|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399001|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399002|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399003|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399004|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399005|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399006|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399007|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399008|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399009|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399010|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399011|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399012|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399013|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399014|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399015|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399016|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399017|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399018|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399019|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399020|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399021|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399022|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399023|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399024|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399025|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399026|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399027|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399028|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399029|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399030|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399031|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399032|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399033|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399034|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399035|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399036|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399037|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399038|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399130|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399039|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399040|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399041|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399042|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399043|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399044|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399045|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399046|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399047|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399048|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399049|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399050|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399051|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399052|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399053|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399054|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399055|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399056|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399057|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399058|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399059|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399060|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399061|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399062|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399063|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399064|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399065|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399066|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399132|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
399067|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399068|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399069|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399070|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399071|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399072|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399073|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399074|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399075|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399076|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399077|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399078|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399079|NCT00996606|E1|Reported Event|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
399080|NCT00996593|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399081|NCT00996593|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399082|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399083|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399084|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399131|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399085|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399086|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399087|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399088|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399089|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399090|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399091|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399092|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399093|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399094|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
408558|NCT00975637|E3|Reported Event|Broda 280 mg|AMG 827: 280 mg SC
399095|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399096|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399097|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399098|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399099|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399100|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399101|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399102|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399103|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399104|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
408559|NCT00975637|E2|Reported Event|Broda 140 mg|AMG 827: 140 mg SC
399105|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399106|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399107|NCT00996593|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
399108|NCT00996580|B1|Baseline|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399109|NCT00996580|P1|Participant Flow|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399110|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
399111|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399112|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399113|NCT00996580|O1|Outcome|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399114|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
399115|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399116|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399117|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
399118|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399119|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399120|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
399121|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399122|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399123|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
399124|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399125|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399126|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
399127|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399128|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399129|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
408560|NCT00975637|E1|Reported Event|Broda 210 mg|AMG 827: 210 mg SC
399133|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
399134|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399135|NCT00996580|E1|Reported Event|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
399136|NCT00996502|B1|Baseline|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
399137|NCT00996502|P1|Participant Flow|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
399138|NCT00996502|O1|Outcome|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
399139|NCT00996502|E1|Reported Event|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
399140|NCT00996476|B6|Baseline|Total|Total of all reporting groups
399141|NCT00996476|B5|Baseline|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399142|NCT00996476|B4|Baseline|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399143|NCT00996476|B3|Baseline|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399144|NCT00996476|B2|Baseline|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399145|NCT00996476|B1|Baseline|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399146|NCT00996476|P5|Participant Flow|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399147|NCT00996476|P4|Participant Flow|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399148|NCT00996476|P3|Participant Flow|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399881|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
399149|NCT00996476|P2|Participant Flow|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399150|NCT00996476|P1|Participant Flow|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399151|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399152|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399153|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399154|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399155|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399156|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
399157|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
399158|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
399159|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
399160|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
399161|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
399162|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399163|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399164|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399165|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399166|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399167|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399168|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399169|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399170|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
411319|NCT00967486|E1|Reported Event|Routine Shunt|routine methods of CEA
399171|NCT00996476|O6|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399172|NCT00996476|O5|Outcome|All TMC435|TMC435 50 mg or 100 mg capsule orally once daily for 12 or 24 weeks
399173|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399174|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399175|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399176|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399177|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399178|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399179|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399180|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399181|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399182|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399183|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399184|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399185|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399186|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399187|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399188|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399189|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399190|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399284|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399191|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399192|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399193|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399194|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399195|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399196|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399197|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399198|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399199|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399200|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399201|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399202|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399203|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399204|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399205|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399206|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399207|NCT00996476|O3|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399208|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
399209|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
399210|NCT00996476|E5|Reported Event|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
399211|NCT00996476|E4|Reported Event|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399255|NCT00996346|P3|Participant Flow|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
399212|NCT00996476|E3|Reported Event|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
399213|NCT00996476|E2|Reported Event|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399214|NCT00996476|E1|Reported Event|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
399215|NCT00996437|B3|Baseline|Total|Total of all reporting groups
399216|NCT00996437|B2|Baseline|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399217|NCT00996437|B1|Baseline|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399218|NCT00996437|P2|Participant Flow|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399219|NCT00996437|P1|Participant Flow|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399220|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399221|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399222|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399223|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399224|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399225|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399226|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399227|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399228|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399229|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399230|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399231|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399232|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399233|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399234|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399235|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399236|NCT00996437|E2|Reported Event|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
399237|NCT00996437|E1|Reported Event|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
399238|NCT00996372|B3|Baseline|Total|Total of all reporting groups
399239|NCT00996372|B2|Baseline|Placebo|
399240|NCT00996372|B1|Baseline|Flibanserin|
399241|NCT00996372|P2|Participant Flow|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
399242|NCT00996372|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
399243|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
399244|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
399245|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
399246|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
399247|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
399248|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
399249|NCT00996372|E2|Reported Event|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
399250|NCT00996372|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
399251|NCT00996346|B4|Baseline|Total|Total of all reporting groups
399252|NCT00996346|B3|Baseline|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
399253|NCT00996346|B2|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
399254|NCT00996346|B1|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
399256|NCT00996346|P2|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
399257|NCT00996346|P1|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
399258|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).~In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.~The treatment consists of:~Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.~The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
399259|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).~In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.~The treatment consists of:~Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.~The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
399260|NCT00996346|E3|Reported Event|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
399261|NCT00996346|E2|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
399262|NCT00996346|E1|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
399263|NCT00996333|B1|Baseline|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
399264|NCT00996333|P1|Participant Flow|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
399265|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
399266|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
399267|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
399268|NCT00996333|E1|Reported Event|Gemzar, Taxotere, Xeloda|"Gemcitabine, Docetaxel, Capecitabine:~Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
399269|NCT00996307|B5|Baseline|Total|Total of all reporting groups
399270|NCT00996307|B4|Baseline|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399271|NCT00996307|B3|Baseline|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399272|NCT00996307|B2|Baseline|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399273|NCT00996307|B1|Baseline|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399274|NCT00996307|P4|Participant Flow|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399275|NCT00996307|P3|Participant Flow|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399276|NCT00996307|P2|Participant Flow|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399277|NCT00996307|P1|Participant Flow|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399278|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399279|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399280|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399281|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399282|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399283|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399333|NCT00996307|E1|Reported Event|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399285|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399286|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399287|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399288|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399289|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399290|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399291|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399292|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399293|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399294|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399295|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399296|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399297|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399298|NCT00996307|O8|Outcome|15_(0)MF59-with Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399299|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399300|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399301|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399302|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399303|NCT00996307|O3|Outcome|7.5_(50)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399304|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399305|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399306|NCT00996307|O8|Outcome|15_(0)MF59-Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399307|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399308|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399309|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399310|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399311|NCT00996307|O3|Outcome|7.5_(50)MF59-No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399312|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399313|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399314|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399315|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399316|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399317|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399318|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399319|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399320|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399321|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399322|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399323|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399324|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399325|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399326|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399327|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399328|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399329|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399330|NCT00996307|E4|Reported Event|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399331|NCT00996307|E3|Reported Event|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
399332|NCT00996307|E2|Reported Event|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
399335|NCT00996281|B2|Baseline|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399336|NCT00996281|B1|Baseline|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399337|NCT00996281|P2|Participant Flow|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399338|NCT00996281|P1|Participant Flow|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399339|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399340|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399341|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399342|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399343|NCT00996281|E2|Reported Event|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399344|NCT00996281|E1|Reported Event|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
399345|NCT00996216|B1|Baseline|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399363|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399364|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399882|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
399346|NCT00996216|P1|Participant Flow|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399347|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399348|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399349|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399350|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399351|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399352|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399365|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399366|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399367|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399353|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399354|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399355|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399356|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399357|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399358|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399359|NCT00996216|E2|Reported Event|Eltrombopag (Part 2)|Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
399360|NCT00996216|E1|Reported Event|Eltrombopag (Part 1)|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.
399361|NCT00996203|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399362|NCT00996203|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399368|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399369|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399370|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399371|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399372|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399373|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399374|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399375|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399376|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399377|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399378|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399379|NCT00996203|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
399380|NCT00996164|B3|Baseline|Total|Total of all reporting groups
399381|NCT00996164|B2|Baseline|Placebo|placebo 1 tab po qd
399382|NCT00996164|B1|Baseline|Flibanserin 100 mg|flibanserin 100mg po qd
399383|NCT00996164|P2|Participant Flow|Placebo|placebo 1 tab po qd
399384|NCT00996164|P1|Participant Flow|Flibanserin 100 mg|flibanserin 100mg po qd
399385|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd~Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
399386|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd~Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
399387|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd~Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
399388|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd~Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
399389|NCT00996164|E2|Reported Event|Placebo|placebo 1 tab po qd
399390|NCT00996164|E1|Reported Event|Flibanserin 100 mg|flibanserin 100mg po qd
399391|NCT00996125|B3|Baseline|Total|Total of all reporting groups
399392|NCT00996125|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399393|NCT00996125|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399394|NCT00996125|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399395|NCT00996125|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399396|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399397|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399398|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399399|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399400|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399401|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399402|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399403|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399404|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399405|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399406|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399883|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
399407|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399408|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399409|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399410|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399411|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399412|NCT00996125|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399413|NCT00996125|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
399414|NCT00996034|B1|Baseline|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
399415|NCT00996034|P1|Participant Flow|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
399416|NCT00996034|O1|Outcome|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
399417|NCT00996034|E1|Reported Event|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
399418|NCT00995930|B3|Baseline|Total|Total of all reporting groups
399419|NCT00995930|B2|Baseline|ACZ885|150 mg SQ monthly
399420|NCT00995930|B1|Baseline|Placebo|SQ monthly
399421|NCT00995930|P2|Participant Flow|ACZ885|150 mg SQ monthly
399422|NCT00995930|P1|Participant Flow|Placebo|SQ monthly
399423|NCT00995930|O1|Outcome|ACZ885|150 mg SQ monthly
399424|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399425|NCT00995930|O1|Outcome|Placebo|SQ monthly
399426|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399427|NCT00995930|O1|Outcome|Placebo|SQ monthly
399428|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399429|NCT00995930|O1|Outcome|Placebo|SQ monthly
399430|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399431|NCT00995930|O1|Outcome|Placebo|SQ monthly
399432|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399433|NCT00995930|O1|Outcome|Placebo|SQ monthly
399434|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399435|NCT00995930|O1|Outcome|Placebo|SQ monthly
399436|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399437|NCT00995930|O1|Outcome|Placebo|SQ monthly
399438|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399439|NCT00995930|O1|Outcome|Placebo|SQ monthly
399440|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399441|NCT00995930|O1|Outcome|Placebo|SQ monthly
399442|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399443|NCT00995930|O1|Outcome|Placebo|SQ monthly
399444|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399445|NCT00995930|O1|Outcome|Placebo|SQ monthly
399446|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
399447|NCT00995930|O1|Outcome|Placebo|SQ monthly
399448|NCT00995930|E2|Reported Event|Placebo|SQ monthly
399449|NCT00995930|E1|Reported Event|ACZ885 150mg|ACZ885 150mg
399450|NCT00995904|B1|Baseline|All Patients|All patients that were enrolled in the study.
399451|NCT00995904|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
399452|NCT00995904|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
399453|NCT00995904|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
399454|NCT00995904|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
399492|NCT00995865|E2|Reported Event|Mid Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
399455|NCT00995904|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
399456|NCT00995904|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
399457|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399458|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399459|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399460|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399461|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399462|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399463|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
399464|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
399465|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
399466|NCT00995904|E3|Reported Event|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399467|NCT00995904|E2|Reported Event|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399468|NCT00995904|E1|Reported Event|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
399469|NCT00995865|B4|Baseline|Total|Total of all reporting groups
399470|NCT00995865|B3|Baseline|Placebo Group|This third group of 12 subjects were to receive a placebo (0.9% normal saline for injection).
399471|NCT00995865|B2|Baseline|Mid-Dose Group|Two groups of 24 subjects each were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for this (mid dose) group.
399472|NCT00995865|B1|Baseline|High Dose Group|Two groups of 24 subjects each, (one arm called a high dose group, the other a Mid-Dose group) were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for the (mid dose).
399473|NCT00995865|P3|Participant Flow|Placebo|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
399474|NCT00995865|P2|Participant Flow|Mid Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399475|NCT00995865|P1|Participant Flow|High Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399476|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.~12 Subjects were examined in this group."
399477|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399478|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~24 Subjects were examined in this group."
399479|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
399480|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399481|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399482|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
399483|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399484|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399485|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.~12 Subjects were examined in this group."
399486|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
399487|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~24 Subjects were examined in this group."
399488|NCT00995865|E6|Reported Event|Placebo Second Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% Second injection."
399489|NCT00995865|E5|Reported Event|Mid Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection."
399490|NCT00995865|E4|Reported Event|High Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection at an interval of 21 days"
399491|NCT00995865|E3|Reported Event|Placebo First Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% First injection."
399715|NCT00995345|O1|Outcome|Placebo|Tablet
399716|NCT00995345|E5|Reported Event|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
399493|NCT00995865|E1|Reported Event|High Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
399494|NCT00995774|B3|Baseline|Total|Total of all reporting groups
399495|NCT00995774|B2|Baseline|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
399496|NCT00995774|B1|Baseline|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
399497|NCT00995774|P2|Participant Flow|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
399498|NCT00995774|P1|Participant Flow|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
399499|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
399500|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
399501|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
399502|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
399503|NCT00995774|E2|Reported Event|Arm 2|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
399504|NCT00995774|E1|Reported Event|Arm 1|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
399505|NCT00995761|B1|Baseline|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
399506|NCT00995761|P1|Participant Flow|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
399507|NCT00995761|O1|Outcome|Biweekly Schedule of Docetaxel and Cisplatin|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC.
399508|NCT00995761|E1|Reported Event|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
399509|NCT00995722|B3|Baseline|Total|Total of all reporting groups
399510|NCT00995722|B2|Baseline|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399511|NCT00995722|B1|Baseline|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399512|NCT00995722|P2|Participant Flow|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399513|NCT00995722|P1|Participant Flow|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399514|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399515|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399516|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399517|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399518|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399717|NCT00995345|E4|Reported Event|Dose 3: KRP-104|100 mg QD
399718|NCT00995345|E3|Reported Event|Dose 2: KRP-104|80 mg QD
399519|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399520|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399521|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399522|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399523|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399524|NCT00995722|E2|Reported Event|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399525|NCT00995722|E1|Reported Event|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
399526|NCT00995709|B4|Baseline|Total|Total of all reporting groups
399527|NCT00995709|B3|Baseline|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399528|NCT00995709|B2|Baseline|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
399529|NCT00995709|B1|Baseline|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399530|NCT00995709|P3|Participant Flow|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399531|NCT00995709|P2|Participant Flow|AIN457C 300 mg Monthly Dosage Regimen|"AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.~One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication"
399532|NCT00995709|P1|Participant Flow|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399533|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399534|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
399535|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399536|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399537|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
399538|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399539|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399540|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
399541|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399542|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399543|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
399544|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399545|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399546|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
399547|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399548|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
399549|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
399550|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399551|NCT00995709|E3|Reported Event|Placebo|Placebo was administered in 2 s.c. injections
399552|NCT00995709|E2|Reported Event|AIN457 300mg Monthly|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399553|NCT00995709|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
399554|NCT00995670|B4|Baseline|Total|Total of all reporting groups
399555|NCT00995670|B3|Baseline|Statin and Glucose|"Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Statin: 40 mg of simvastatin 17 volunteers were studied 31 times in this arm."
399556|NCT00995670|B2|Baseline|Vitamin C and Glucose|"To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Vitamin C: 1 gm iv bolus injection 5 min before I/R injury 16 volunteers were studied 25 times in this arm."
399557|NCT00995670|B1|Baseline|Sevoflurane and Glucose|"Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min to prevent the anesthetic preconditioning (sevoflurane) protection against subsequent I/R injury.~Sevoflurane: 1 minimum alveolar concentration (MAC) for 20 min (after hour of glucose and before I/R) 26 volunteers were studied 67 times in this arm."
399558|NCT00995670|P3|Participant Flow|Statin and Glucose|Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.
399559|NCT00995670|P2|Participant Flow|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
399560|NCT00995670|P1|Participant Flow|Sevoflurane and Glucose|Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
399561|NCT00995670|O3|Outcome|Statin and Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
399562|NCT00995670|O2|Outcome|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
399563|NCT00995670|O1|Outcome|Sevoflurane and Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
399564|NCT00995670|E3|Reported Event|Statins & Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
399565|NCT00995670|E2|Reported Event|Vitamin C & Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
399566|NCT00995670|E1|Reported Event|Sevoflurane & Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
399567|NCT00995566|B1|Baseline|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399568|NCT00995566|P1|Participant Flow|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399569|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399570|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399571|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399572|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399573|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399574|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399575|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399576|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399577|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399578|NCT00995566|E1|Reported Event|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
399579|NCT00995553|B3|Baseline|Total|Total of all reporting groups
399719|NCT00995345|E2|Reported Event|Dose 1: KRP-104|40 mg QD
399720|NCT00995345|E1|Reported Event|Placebo|Tablet
399580|NCT00995553|B2|Baseline|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
399581|NCT00995553|B1|Baseline|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
399582|NCT00995553|P2|Participant Flow|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
399583|NCT00995553|P1|Participant Flow|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
399584|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
399585|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
399586|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
399587|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
399588|NCT00995553|E2|Reported Event|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
399589|NCT00995553|E1|Reported Event|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
399590|NCT00995501|B9|Baseline|Total|Total of all reporting groups
399591|NCT00995501|B8|Baseline|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399592|NCT00995501|B7|Baseline|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399593|NCT00995501|B6|Baseline|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399594|NCT00995501|B5|Baseline|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399721|NCT00995085|B1|Baseline|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
412482|NCT00964431|E3|Reported Event|Celecoxib 400 mg|
399595|NCT00995501|B4|Baseline|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
399596|NCT00995501|B3|Baseline|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399597|NCT00995501|B2|Baseline|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399598|NCT00995501|B1|Baseline|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
399599|NCT00995501|P8|Participant Flow|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399600|NCT00995501|P7|Participant Flow|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399601|NCT00995501|P6|Participant Flow|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399602|NCT00995501|P5|Participant Flow|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399603|NCT00995501|P4|Participant Flow|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
399604|NCT00995501|P3|Participant Flow|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399605|NCT00995501|P2|Participant Flow|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399722|NCT00995085|P1|Participant Flow|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
399723|NCT00995085|O1|Outcome|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
399606|NCT00995501|P1|Participant Flow|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
399607|NCT00995501|O8|Outcome|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399608|NCT00995501|O7|Outcome|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399609|NCT00995501|O6|Outcome|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399610|NCT00995501|O5|Outcome|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399611|NCT00995501|O4|Outcome|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
399612|NCT00995501|O3|Outcome|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399613|NCT00995501|O2|Outcome|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399614|NCT00995501|O1|Outcome|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
399615|NCT00995501|O8|Outcome|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399616|NCT00995501|O7|Outcome|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399724|NCT00995085|E1|Reported Event|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
399725|NCT00995020|B3|Baseline|Total|Total of all reporting groups
399617|NCT00995501|O6|Outcome|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399618|NCT00995501|O5|Outcome|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399619|NCT00995501|O4|Outcome|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
399620|NCT00995501|O3|Outcome|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399621|NCT00995501|O2|Outcome|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399622|NCT00995501|O1|Outcome|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
399623|NCT00995501|E8|Reported Event|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399624|NCT00995501|E7|Reported Event|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399625|NCT00995501|E6|Reported Event|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399626|NCT00995501|E5|Reported Event|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399627|NCT00995501|E4|Reported Event|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
399884|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
399885|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
399628|NCT00995501|E3|Reported Event|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
399629|NCT00995501|E2|Reported Event|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
399630|NCT00995501|E1|Reported Event|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
399631|NCT00995488|B1|Baseline|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
399632|NCT00995488|P1|Participant Flow|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
399633|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
399634|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
399635|NCT00995488|E1|Reported Event|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
399636|NCT00995449|B5|Baseline|Total|Total of all reporting groups
399637|NCT00995449|B4|Baseline|Placebo|Placebo comparator
399638|NCT00995449|B3|Baseline|KB003 600 mg|600 mg, KB003 a monoclonal antibody
399639|NCT00995449|B2|Baseline|KB003 200 mg|Dose group not evaluated in this portion of study
399640|NCT00995449|B1|Baseline|KB003 70mg|Dose group not evaluated in this portion of study
399641|NCT00995449|P4|Participant Flow|Placebo|Placebo comparator
399642|NCT00995449|P3|Participant Flow|KB003 600 mg|600 mg, KB003 a monoclonal antibody
399643|NCT00995449|P2|Participant Flow|KB003 200 mg|Dose group not evaluated in this portion of study
399644|NCT00995449|P1|Participant Flow|KB003 70mg|Dose group not evaluated in this portion of study
399645|NCT00995449|O2|Outcome|Placebo|Placebo comparator
399646|NCT00995449|O1|Outcome|KB003 600 mg|600 mg, KB003 a monoclonal antibody
399647|NCT00995449|E4|Reported Event|Placebo|Placebo comparator
399648|NCT00995449|E3|Reported Event|KB003 600 mg|600 mg, KB003 a monoclonal antibody
399649|NCT00995449|E2|Reported Event|KB003 200 mg|Dose group not evaluated in this portion of study
399650|NCT00995449|E1|Reported Event|KB003 70mg|Dose group not evaluated in this portion of study
399651|NCT00995436|B4|Baseline|Total|Total of all reporting groups
399652|NCT00995436|B3|Baseline|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
399653|NCT00995436|B2|Baseline|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
399654|NCT00995436|B1|Baseline|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
399655|NCT00995436|P3|Participant Flow|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
399656|NCT00995436|P2|Participant Flow|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
399657|NCT00995436|P1|Participant Flow|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
399658|NCT00995436|O3|Outcome|Headgear|
399659|NCT00995436|O2|Outcome|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
399660|NCT00995436|O1|Outcome|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
399661|NCT00995436|E3|Reported Event|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
399662|NCT00995436|E2|Reported Event|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
399663|NCT00995436|E1|Reported Event|Headgear|"Device Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage: Extra oral anchorage"
399664|NCT00995410|B1|Baseline|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
399665|NCT00995410|P1|Participant Flow|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
399666|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
399886|NCT00994461|E3|Reported Event|Placebo|Placebo tablet three times a day with meal for 2 weeks
399667|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
399668|NCT00995410|E1|Reported Event|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
399669|NCT00995371|B3|Baseline|Total|Total of all reporting groups
399670|NCT00995371|B2|Baseline|Epidural Steroid Injection|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
399671|NCT00995371|B1|Baseline|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
399672|NCT00995371|P2|Participant Flow|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
399673|NCT00995371|P1|Participant Flow|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
399674|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
399675|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
399676|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
399677|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
399678|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
399679|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
399680|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
399681|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
399682|NCT00995371|E3|Reported Event|ESI Cross-over to Lumbar Decompression With Mild|Group 3: Patients in the Epidural Steroid Injection (ESI) group treated by the physicians in accordance with product labeling and indications for use, crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure
399683|NCT00995371|E2|Reported Event|Epidural Steroid Injection|"Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.~The ESI group analyzed crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure"
399684|NCT00995371|E1|Reported Event|Vertos Mild® Minimally-Invasive Lumbar Decompression|Group 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
399685|NCT00995345|B6|Baseline|Total|Total of all reporting groups
399686|NCT00995345|B5|Baseline|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
399687|NCT00995345|B4|Baseline|Dose 3: KRP-104|100 mg QD
399688|NCT00995345|B3|Baseline|Dose 2: KRP-104|80 mg QD
399689|NCT00995345|B2|Baseline|Dose 1: KRP-104|40 mg QD
399690|NCT00995345|B1|Baseline|Placebo|Tablet
399691|NCT00995345|P5|Participant Flow|Dose 4: KRP-104|20 mg /120 mg QD (dose switch at week12)
399692|NCT00995345|P4|Participant Flow|Dose 3: KRP-104|100 mg QD
399693|NCT00995345|P3|Participant Flow|Dose 2: KRP-104|80 mg QD
399694|NCT00995345|P2|Participant Flow|Dose 1: KRP-104|40 mg QD
399695|NCT00995345|P1|Participant Flow|Placebo|Tablet
399696|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
399697|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
399698|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
399699|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
399700|NCT00995345|O1|Outcome|Placebo|Tablet
399701|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
399702|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
399703|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
399704|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
399705|NCT00995345|O1|Outcome|Placebo|Tablet
399706|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
399707|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
399708|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
399709|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
399710|NCT00995345|O1|Outcome|Placebo|Tablet
399711|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
399712|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
399713|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
399714|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
399726|NCT00995020|B2|Baseline|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
399727|NCT00995020|B1|Baseline|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
399728|NCT00995020|P2|Participant Flow|LLETZ Cone: Large Loop Excision of Transformation Zone - Cone|The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium.
399729|NCT00995020|P1|Participant Flow|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ (straight wire excision of the transformation zone), which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
399730|NCT00995020|O2|Outcome|SWETZ|SWETZ uses a 1cm straight 0.20mm wire to fashion a similar excision.
399731|NCT00995020|O1|Outcome|LLETZ - Cone|LLETZ - cone was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
399732|NCT00995020|O2|Outcome|LLETZ Cone|LLETZ cone,the standard procedure is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
399733|NCT00995020|O1|Outcome|SWETZ|SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
399734|NCT00995020|E2|Reported Event|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
399735|NCT00995020|E1|Reported Event|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
399736|NCT00995007|B3|Baseline|Total|Total of all reporting groups
399737|NCT00995007|B2|Baseline|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399738|NCT00995007|B1|Baseline|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
399739|NCT00995007|P2|Participant Flow|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399740|NCT00995007|P1|Participant Flow|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
399741|NCT00995007|O3|Outcome|Cross Over to Vandetanib|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399804|NCT00994682|P1|Participant Flow|Placebo|After all participants receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on placebo (or pioglitazone) in a randomized, double-blind,placebo-controlled study design by the research pharmacy. Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
399887|NCT00994461|E2|Reported Event|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
399742|NCT00995007|O2|Outcome|Vandetanib With Carboplatin|"Sequential Group (carboplatin followed by vandetanib)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399743|NCT00995007|O1|Outcome|Carboplatin|"Combo Group (both drugs together)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399744|NCT00995007|O4|Outcome|Anaplastic Astrocytoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
399745|NCT00995007|O3|Outcome|Anaplastic Astrocytoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399746|NCT00995007|O2|Outcome|Glioblastoma (Carboplation Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
399747|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399748|NCT00995007|O4|Outcome|Anaplastic Astrocytomas (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
399749|NCT00995007|O3|Outcome|Anaplastic Astrocytomas (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399750|NCT00995007|O2|Outcome|Glioblastoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
399751|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399752|NCT00995007|E3|Reported Event|Crossover to Vandetanib|ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
399753|NCT00995007|E2|Reported Event|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
399754|NCT00995007|E1|Reported Event|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
399855|NCT00994604|O2|Outcome|Broccoli Sprout Extract - BD|pre- and post-consumption of broccoli sprout extract for 2 weeks
399856|NCT00994604|O1|Outcome|Broccoli Sprout Extract - BP|pre- and post-consumption of broccoli sprout extract for 2 weeks
399755|NCT00994929|B1|Baseline|Neumega (Oprelveken, Interleukin 11)|The VWD subjects included two with type 1 VWD and two with type 2 VWD, including one with type 2B, with increased platelet aggregation at low strength ristocetin and absent high molecular weight multimers, and one with type 2M disease, with reduced VWF:RCoF/ VWF:Ag ratio <0.50, per NHLBI criteria (Table 2).5 All subjects had positive past bleeding histories. Pregnancy, lactation, heart disease, uncontrolled hypertension, arrhythmia, thrombosis, recent surgery or receipt of blood products were exclusions. A total of nine subjects were enrolled and completed study, including five with hemophilia A and four with VWD. The median age was 26 years, range 22-51 years
399756|NCT00994929|P1|Participant Flow|Neumega (Oprelveken, Interleukin 11)|25 µg/kilogram of body weight of rhIL-11 subcutaneously administered on days 1 to 4. On day 4 following rhIL-11 injection DDAVP was subsequently given at 0.3 mcg/kg intravenously over 30 minutes. For any subject with past allergic reactions, hypersensitivity, or seizures with DDAVP, or in whom DDAVP is contraindicated, DDAVP was not given: only rhIL-11 was given on Day 4.
399757|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
399758|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
399759|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11.
399760|NCT00994929|E1|Reported Event|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed on day 4 by DDAVP 0.3 microgram/kg by intravenous infusion.
399761|NCT00994760|B1|Baseline|GENISIS|Intranasal Fentanyl Spray
399762|NCT00994760|P1|Participant Flow|GENISIS|Intranasal Fentanyl Spray
399763|NCT00994760|O1|Outcome|Caregiver at Final Visit|
399764|NCT00994760|O1|Outcome|Caregiver at Final Visit|
399765|NCT00994760|O1|Outcome|Caregiver at Final Visit|
399766|NCT00994760|O1|Outcome|Caregiver at Final Visit|
399767|NCT00994760|O1|Outcome|Patients at Final Visit|
399768|NCT00994760|O1|Outcome|Patients at Final Visit|
399769|NCT00994760|O2|Outcome|Last Visit (LV)|
399770|NCT00994760|O1|Outcome|First Visit (FV)(Patients With Previous BTP-medication Only)|
399771|NCT00994760|O1|Outcome|Patients at Final Visit|
399772|NCT00994760|O2|Outcome|Last Visit|
399773|NCT00994760|O1|Outcome|Initial Visit|
399774|NCT00994760|O2|Outcome|Last Visit|
399775|NCT00994760|O1|Outcome|Initial Visit|
399776|NCT00994760|O2|Outcome|Last Visit|
399777|NCT00994760|O1|Outcome|Initial Visit|
399778|NCT00994760|O2|Outcome|Last Visit|
399779|NCT00994760|O1|Outcome|Initial Visit|
399780|NCT00994760|O2|Outcome|Last Visit|
399781|NCT00994760|O1|Outcome|Initial Visit|
399782|NCT00994760|O2|Outcome|Last Visit|
399783|NCT00994760|O1|Outcome|Initial Visit|
399784|NCT00994760|O2|Outcome|Last Visit|
399785|NCT00994760|O1|Outcome|Initial Visit|
399786|NCT00994760|O1|Outcome|Patients at First Visit|
399787|NCT00994760|O1|Outcome|First Visit|
399788|NCT00994760|O2|Outcome|Last Visit (LV)|
399789|NCT00994760|O1|Outcome|Initial Visit (IV)|
399790|NCT00994760|O1|Outcome|GENISIS|Intranasal Fentanyl Spray
399791|NCT00994760|O1|Outcome|Physician Last Visit (LV)|
399792|NCT00994760|O2|Outcome|Last Visit (LV)|
399793|NCT00994760|O1|Outcome|First Visit (FV): Patients With Previous BTP- Medication Only|
399794|NCT00994760|O1|Outcome|Last Visit|
399795|NCT00994760|O2|Outcome|Last Visit|
399796|NCT00994760|O1|Outcome|Initial Visit|
399797|NCT00994760|O2|Outcome|Study End|
399798|NCT00994760|O1|Outcome|Study Start|
399799|NCT00994760|E1|Reported Event|All Patients Treated|
399800|NCT00994682|B3|Baseline|Total|Total of all reporting groups
399801|NCT00994682|B2|Baseline|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399802|NCT00994682|B1|Baseline|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399803|NCT00994682|P2|Participant Flow|Pioglitazone|After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or T2DM and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
399888|NCT00994461|E1|Reported Event|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
399805|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399806|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399807|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399808|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399809|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399810|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399811|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399812|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
399813|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399814|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399857|NCT00994604|E1|Reported Event|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
399858|NCT00994461|B4|Baseline|Total|Total of all reporting groups
399859|NCT00994461|B3|Baseline|Placebo|Placebo tablet three times a day with meal for 2 weeks
399860|NCT00994461|B2|Baseline|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
399815|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399816|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399817|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399818|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399819|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399820|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399821|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399822|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399823|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399824|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399825|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399861|NCT00994461|B1|Baseline|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
399862|NCT00994461|P3|Participant Flow|Placebo|Placebo tablet three times a day with meal for 2 weeks
399863|NCT00994461|P2|Participant Flow|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
399864|NCT00994461|P1|Participant Flow|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
399826|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399827|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399828|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399829|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399830|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399831|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399832|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399833|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399834|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399835|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399836|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399865|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
399866|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
399837|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399838|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399839|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399840|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399841|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399842|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399843|NCT00994682|E4|Reported Event|Pioglitazone (Months 18-36)|After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
399844|NCT00994682|E3|Reported Event|Placebo (PIO Open-label)|After being randomized to placebo for the first 18 months, patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
399845|NCT00994682|E2|Reported Event|Pioglitazone (First 18 Months)|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
399846|NCT00994682|E1|Reported Event|Placebo (First 18 Months)|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
399847|NCT00994643|B1|Baseline|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
399848|NCT00994643|P1|Participant Flow|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
399849|NCT00994643|O1|Outcome|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
399850|NCT00994643|E1|Reported Event|Treatment (Interleukin Therapy, Monoclonal Antibody)|"Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.~Rituximab: Given IV~Interleukin-2: Given SC"
399851|NCT00994604|B1|Baseline|Broccoli Sprout Extract|broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
399852|NCT00994604|P1|Participant Flow|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
399853|NCT00994604|O2|Outcome|Airway Size Post BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
399854|NCT00994604|O1|Outcome|Airway Size Pre BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
399867|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
399890|NCT00994448|B2|Baseline|Placebo (Sugar Pill)|Matching placebo tablets twice a day
399891|NCT00994448|B1|Baseline|Bupropion|Bupropion SR 150 mg twice a day
399892|NCT00994448|P2|Participant Flow|Placebo (Sugar Pill)|Matching placebo tablets twice a day
399893|NCT00994448|P1|Participant Flow|Bupropion|Bupropion SR 150 mg twice a day
399894|NCT00994448|O2|Outcome|Placebo (Sugar Pill)|Matching placebo tablets twice a day
399895|NCT00994448|O1|Outcome|Bupropion|Bupropion SR 150 mg twice a day
399896|NCT00994448|E2|Reported Event|Placebo (Sugar Pill)|Matching placebo tablets twice a day
399897|NCT00994448|E1|Reported Event|Bupropion|Bupropion SR 150 mg twice a day
399898|NCT00994422|B3|Baseline|Total|Total of all reporting groups
399899|NCT00994422|B2|Baseline|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
399900|NCT00994422|B1|Baseline|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
399901|NCT00994422|P2|Participant Flow|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
399902|NCT00994422|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
399903|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
399904|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
399905|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
399906|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
399907|NCT00994422|O2|Outcome|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
399908|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
399909|NCT00994422|E2|Reported Event|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
399910|NCT00994422|E1|Reported Event|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
399911|NCT00994318|B4|Baseline|Total|Total of all reporting groups
399912|NCT00994318|B3|Baseline|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
399913|NCT00994318|B2|Baseline|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
399914|NCT00994318|B1|Baseline|FCM (High Ferritin Target|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
399915|NCT00994318|P3|Participant Flow|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
399916|NCT00994318|P2|Participant Flow|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
399917|NCT00994318|P1|Participant Flow|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
399918|NCT00994318|O3|Outcome|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
399919|NCT00994318|O2|Outcome|FCM (Low Ferritin Level)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 100-200 mcg/L
399920|NCT00994318|O1|Outcome|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 400-600 mcg/L
399921|NCT00994318|E3|Reported Event|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
399922|NCT00994318|E2|Reported Event|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
399923|NCT00994318|E1|Reported Event|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
399924|NCT00994279|B3|Baseline|Total|Total of all reporting groups
399925|NCT00994279|B2|Baseline|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
399926|NCT00994279|B1|Baseline|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
399927|NCT00994279|P2|Participant Flow|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
399928|NCT00994279|P1|Participant Flow|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
399929|NCT00994279|O2|Outcome|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
399930|NCT00994279|O1|Outcome|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
399931|NCT00994279|O2|Outcome|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
399932|NCT00994279|O1|Outcome|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
399933|NCT00994279|E2|Reported Event|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
399934|NCT00994279|E1|Reported Event|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
399935|NCT00994240|B3|Baseline|Total|Total of all reporting groups
399936|NCT00994240|B2|Baseline|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399937|NCT00994240|B1|Baseline|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399938|NCT00994240|P2|Participant Flow|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399939|NCT00994240|P1|Participant Flow|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399940|NCT00994240|O2|Outcome|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399941|NCT00994240|O1|Outcome|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399942|NCT00994240|E2|Reported Event|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399943|NCT00994240|E1|Reported Event|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
399944|NCT00994214|B5|Baseline|Total|Total of all reporting groups
399945|NCT00994214|B4|Baseline|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections..
399946|NCT00994214|B3|Baseline|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
399947|NCT00994214|B2|Baseline|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
399948|NCT00994214|B1|Baseline|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
399949|NCT00994214|P4|Participant Flow|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
399950|NCT00994214|P3|Participant Flow|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
399951|NCT00994214|P2|Participant Flow|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
399952|NCT00994214|P1|Participant Flow|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
399953|NCT00994214|O9|Outcome|Overall - Part B|
399954|NCT00994214|O8|Outcome|Part B: Arm D: BIM 23A760 6 mg|
399955|NCT00994214|O7|Outcome|Part B: Arm C: BIM 23A760 4 mg|
399956|NCT00994214|O6|Outcome|Part B: Arm B: BIM 23A760 2 mg|
399957|NCT00994214|O5|Outcome|Overall - Part A|
399958|NCT00994214|O4|Outcome|Part A: Arm D: BIM 23A760 6 mg|
399959|NCT00994214|O3|Outcome|Part A: Arm C: BIM 23A760 4 mg|
399960|NCT00994214|O2|Outcome|Part A: Arm B: BIM 23A760 2 mg|
399961|NCT00994214|O1|Outcome|Part A: Arm A: BIM 23A760 1 mg|
399962|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
399963|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
399964|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
399965|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
399966|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
399967|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
399968|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
399969|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
399970|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
399971|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
399972|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections
399973|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections
399974|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections
399975|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
399976|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
399977|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
399978|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
399979|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
399980|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
399981|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
399982|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
399983|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
399984|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
399985|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
399986|NCT00994214|E9|Reported Event|Overall - Part B|
399987|NCT00994214|E8|Reported Event|Part B: Arm D: BIM 23A760 6 mg|
399988|NCT00994214|E7|Reported Event|Part B: Arm C: BIM 23A760 4 mg|
399989|NCT00994214|E6|Reported Event|Part B: Arm B: BIM 23A760 2 mg|
399990|NCT00994214|E5|Reported Event|Overall - Part A|
399991|NCT00994214|E4|Reported Event|Part A: Arm D: BIM 23A760 6 mg|
399992|NCT00994214|E3|Reported Event|Part A: Arm C: BIM 23A760 4 mg|
399993|NCT00994214|E2|Reported Event|Part A: Arm B: BIM 23A760 2 mg|
399994|NCT00994214|E1|Reported Event|Part A: Arm A: BIM 23A760 1 mg|
399995|NCT00994175|B1|Baseline|All Participants|All subjects who started the study.
399996|NCT00994175|P2|Participant Flow|Placebo, Then Pioglitazone|Placebo was administered for 16 weeks. This was followed by a 4-week washout period. Subjects were assessed for clinical stability during a second 4-week run-in period prior to crossing over to the Pioglitazone treatment group. Pioglitazone, 30 mg daily, was administered for the initial 2 weeks of the treatment phase, followed by 45 mg daily for an additional 14 weeks.
399997|NCT00994175|P1|Participant Flow|Pioglitazone, Then Placebo|Pioglitazone, 30 mg daily, was administered for the initial 2 weeks of the first treatment phase, followed by 45 mg daily for an additional 14 weeks. This was followed by a 4-week washout period. Subjects were assessed for clinical stability during a second 4-week run-in period prior to crossing over to the placebo phase for 16 weeks in the second treatment phase to receive the placebo.
399998|NCT00994175|O2|Outcome|Placebo|Subjects received a matched placebo.
399999|NCT00994175|O1|Outcome|Pioglitazone|Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
400000|NCT00994175|O2|Outcome|Placebo|Subjects received a matched placebo.
400001|NCT00994175|O1|Outcome|Pioglitazone|Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
400002|NCT00994175|E2|Reported Event|Placebo|Subjects received a matched placebo.
400003|NCT00994175|E1|Reported Event|Pioglitazone|Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
400004|NCT00994123|B4|Baseline|Total|Total of all reporting groups
400005|NCT00994123|B3|Baseline|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
400006|NCT00994123|B2|Baseline|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
400007|NCT00994123|B1|Baseline|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 + Erlotinib in patients with NSCLC
400008|NCT00994123|P3|Participant Flow|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
400009|NCT00994123|P2|Participant Flow|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
400010|NCT00994123|P1|Participant Flow|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 and erlotinib
400011|NCT00994123|O4|Outcome|HRG Low: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
400012|NCT00994123|O3|Outcome|HRG Low: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
400013|NCT00994123|O2|Outcome|HRG High: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
400014|NCT00994123|O1|Outcome|HRG High: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
400015|NCT00994123|O2|Outcome|Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
400016|NCT00994123|O1|Outcome|MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
400017|NCT00994123|O1|Outcome|Phase 1: All Participants|All participants in the dose escalation portion of the Phase 1
400018|NCT00994123|O7|Outcome|Cohort 7|MM-121 20 mg/kg (Q3W IV) + erlotinib 100 mg (PO daily)
400019|NCT00994123|O6|Outcome|Cohort 6|MM-121 20 mg/kg (Q2W IV) + erlotinib 100 mg (PO daily)
400020|NCT00994123|O5|Outcome|Cohort 5|MM-121 20 mg/kg (weekly IV) + erlotinib 100 mg (PO daily)
400021|NCT00994123|O4|Outcome|Cohort 4|MM-121 12 mg/kg (Q2W IV) + 150 mg erlotinib (PO daily)
400022|NCT00994123|O3|Outcome|Cohort 3|MM-121 12 mg/kg (Q2W IV) + 100 mg erlotinib (daily PO)
400023|NCT00994123|O2|Outcome|Cohort 2|6 mg/kg MM-121 Q2W + 150 mg erlotinib (daily PO)
400024|NCT00994123|O1|Outcome|Cohort 1|MM-121 6 mk/kg (Q2W IV) and 100 mg erlotinib (daily PO)
400025|NCT00994123|E3|Reported Event|Ph 1: MM-121 + Erlotinib|Escalating Doses of MM-121 + erlotinib
400026|NCT00994123|E2|Reported Event|Ph 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
400027|NCT00994123|E1|Reported Event|Ph 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
400028|NCT00994110|B3|Baseline|Total|Total of all reporting groups
400029|NCT00994110|B2|Baseline|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
400030|NCT00994110|B1|Baseline|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
400031|NCT00994110|P2|Participant Flow|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
400045|NCT00993954|P2|Participant Flow|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400046|NCT00993954|P1|Participant Flow|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400594|NCT00993031|O1|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400032|NCT00994110|P1|Participant Flow|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
400033|NCT00994110|O2|Outcome|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
400034|NCT00994110|O1|Outcome|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
400035|NCT00994110|E2|Reported Event|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
400036|NCT00994110|E1|Reported Event|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
400037|NCT00993967|B1|Baseline|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
400038|NCT00993967|P1|Participant Flow|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
400039|NCT00993967|O1|Outcome|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
400040|NCT00993967|O1|Outcome|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
400041|NCT00993967|E1|Reported Event|Idebenone|"1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.~idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg"
400042|NCT00993954|B3|Baseline|Total|Total of all reporting groups
400043|NCT00993954|B2|Baseline|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400044|NCT00993954|B1|Baseline|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400072|NCT00993928|E1|Reported Event|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
400047|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400048|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400049|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400050|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400051|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400052|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400053|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400054|NCT00993954|E2|Reported Event|Physician Reduction|"Patients randomized to reduction by physician~Physicians were free to use the reduction method of their choice"
400055|NCT00993954|E1|Reported Event|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
400056|NCT00993928|B3|Baseline|Total|Total of all reporting groups
400057|NCT00993928|B2|Baseline|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
400058|NCT00993928|B1|Baseline|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
400059|NCT00993928|P2|Participant Flow|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
400060|NCT00993928|P1|Participant Flow|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
400061|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
400062|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
400063|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
400064|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
400065|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
400066|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
400067|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
400068|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
400069|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|"Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use. >~> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
400070|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|"Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary. >~> Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
400071|NCT00993928|E2|Reported Event|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
400506|NCT00993265|B3|Baseline|Total|Total of all reporting groups
400073|NCT00993915|B1|Baseline|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400074|NCT00993915|P1|Participant Flow|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400075|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400076|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400077|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400078|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400079|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400080|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400081|NCT00993915|E1|Reported Event|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
400082|NCT00993824|B3|Baseline|Total|Total of all reporting groups
400083|NCT00993824|B2|Baseline|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
400084|NCT00993824|B1|Baseline|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
400085|NCT00993824|P2|Participant Flow|Placebo Then Welchol|Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
400086|NCT00993824|P1|Participant Flow|Welchol Then Placebo|3.75 grams of colesevelam HCl (Welchol) taken for 12 weeks at evening meal, and then crossover to placebo taken at evening meal fro 12 weeks.
400087|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
400088|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
400089|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
400090|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
400091|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
400092|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
400093|NCT00993824|O2|Outcome|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
400094|NCT00993824|O1|Outcome|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
400095|NCT00993824|E2|Reported Event|Placebo|Placebo taken at evening meal
400096|NCT00993824|E1|Reported Event|Welchol|3.75 grams of colesevelam HCl taken at evening meal
400097|NCT00993668|B3|Baseline|Total|Total of all reporting groups
400098|NCT00993668|B2|Baseline|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400099|NCT00993668|B1|Baseline|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400100|NCT00993668|P2|Participant Flow|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400101|NCT00993668|P1|Participant Flow|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
415870|NCT00957944|B3|Baseline|Total|Total of all reporting groups
400102|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400103|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400104|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400105|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400106|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400107|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400108|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400109|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400110|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400111|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400112|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400113|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400114|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400115|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400116|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400117|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400118|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400119|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400120|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
400121|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400122|NCT00993668|E3|Reported Event|Cimzia at Any Time|Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
400123|NCT00993668|E2|Reported Event|Cimzia (Single Blind)|Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4
400124|NCT00993668|E1|Reported Event|Placebo (Single Blind)|Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4
400125|NCT00993655|B4|Baseline|Total|Total of all reporting groups
400126|NCT00993655|B3|Baseline|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400127|NCT00993655|B2|Baseline|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400128|NCT00993655|B1|Baseline|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400129|NCT00993655|P3|Participant Flow|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400130|NCT00993655|P2|Participant Flow|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400131|NCT00993655|P1|Participant Flow|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400132|NCT00993655|O3|Outcome|IP Carboplatin + IV/IP Paclitaxel|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400133|NCT00993655|O2|Outcome|IP Cisplatin + IV/IP Paclitaxel|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400134|NCT00993655|O1|Outcome|IV Carboplatin + IV Paclitaxel|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400135|NCT00993655|O3|Outcome|IP Carboplatin + IV/IP Paclitaxel|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400136|NCT00993655|O2|Outcome|IP Cisplatin + IV/IP Paclitaxel|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400137|NCT00993655|O1|Outcome|IV Carboplatin + IV Paclitaxel|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400138|NCT00993655|O3|Outcome|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400139|NCT00993655|O2|Outcome|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400140|NCT00993655|O1|Outcome|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
401069|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
400141|NCT00993655|E3|Reported Event|Arm 3|"ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400142|NCT00993655|E2|Reported Event|Arm 2|"ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)~cisplatin: Cisplatin 75 mg/m2 intraperitoneal day 1~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles~quality-of-life assessment: day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy"
400143|NCT00993655|E1|Reported Event|Arm 1|"ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles~carboplatin: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.~paclitaxel: Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles"
400144|NCT00993616|B1|Baseline|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
400145|NCT00993616|P1|Participant Flow|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
400146|NCT00993616|O1|Outcome|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
400147|NCT00993616|O1|Outcome|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
400148|NCT00993616|O6|Outcome|Grade 5|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
400149|NCT00993616|O5|Outcome|Grade 4|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
400150|NCT00993616|O4|Outcome|Grade 3|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
400151|NCT00993616|O3|Outcome|Grade 2|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
400152|NCT00993616|O2|Outcome|Grade 1|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
400153|NCT00993616|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
400154|NCT00993616|O1|Outcome|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
400155|NCT00993616|E1|Reported Event|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
400156|NCT00993499|B7|Baseline|Total|Total of all reporting groups
400157|NCT00993499|B6|Baseline|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400158|NCT00993499|B5|Baseline|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400159|NCT00993499|B4|Baseline|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400160|NCT00993499|B3|Baseline|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400161|NCT00993499|B2|Baseline|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400162|NCT00993499|B1|Baseline|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400163|NCT00993499|P6|Participant Flow|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400164|NCT00993499|P5|Participant Flow|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400165|NCT00993499|P4|Participant Flow|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400166|NCT00993499|P3|Participant Flow|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400167|NCT00993499|P2|Participant Flow|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400168|NCT00993499|P1|Participant Flow|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400169|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400170|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400171|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400172|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400173|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400174|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400175|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400176|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400177|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400178|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400179|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400180|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400181|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400182|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400183|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400184|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400185|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400186|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400187|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400188|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400189|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400190|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400191|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400192|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400193|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400194|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400195|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400196|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400197|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400198|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400199|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400200|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400201|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400202|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400203|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400204|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400205|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400206|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400207|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400208|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400209|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400210|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400211|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400212|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400213|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400214|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400215|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400216|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400217|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400218|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400219|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400220|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400221|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400222|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400223|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400224|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400225|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400226|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400227|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400228|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400229|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400230|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400231|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
401070|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
400232|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400233|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400234|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400235|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400236|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400237|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400238|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400239|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400240|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400241|NCT00993499|E6|Reported Event|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
400242|NCT00993499|E5|Reported Event|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
400243|NCT00993499|E4|Reported Event|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
400244|NCT00993499|E3|Reported Event|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
400245|NCT00993499|E2|Reported Event|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
400246|NCT00993499|E1|Reported Event|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
400247|NCT00993473|B3|Baseline|Total|Total of all reporting groups
400248|NCT00993473|B2|Baseline|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400249|NCT00993473|B1|Baseline|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400250|NCT00993473|P2|Participant Flow|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400251|NCT00993473|P1|Participant Flow|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400252|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400253|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400254|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400255|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400256|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400257|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400258|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400259|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400260|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400261|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400262|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400263|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400264|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400265|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400266|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400267|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400268|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400269|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400270|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400271|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400272|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400273|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400274|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400275|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400276|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400277|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400278|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400279|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400280|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400281|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400282|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400283|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
400284|NCT00993473|E2|Reported Event|NPH Insulin|
400285|NCT00993473|E1|Reported Event|Lantus|
400286|NCT00993447|B3|Baseline|Total|Total of all reporting groups
400287|NCT00993447|B2|Baseline|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400288|NCT00993447|B1|Baseline|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400289|NCT00993447|P2|Participant Flow|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400290|NCT00993447|P1|Participant Flow|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400291|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400292|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400293|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400294|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400295|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400296|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400297|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400298|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400299|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400300|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400301|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400302|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400303|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400304|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400305|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400306|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400307|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400308|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400309|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400310|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400311|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400312|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400313|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400314|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400315|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400316|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400317|NCT00993447|E2|Reported Event|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
400318|NCT00993447|E1|Reported Event|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
400319|NCT00993421|B8|Baseline|Total|Total of all reporting groups
400320|NCT00993421|B7|Baseline|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400321|NCT00993421|B6|Baseline|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400322|NCT00993421|B5|Baseline|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400323|NCT00993421|B4|Baseline|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400324|NCT00993421|B3|Baseline|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400325|NCT00993421|B2|Baseline|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400326|NCT00993421|B1|Baseline|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400327|NCT00993421|P7|Participant Flow|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400328|NCT00993421|P6|Participant Flow|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
401071|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
400329|NCT00993421|P5|Participant Flow|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400330|NCT00993421|P4|Participant Flow|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400331|NCT00993421|P3|Participant Flow|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400332|NCT00993421|P2|Participant Flow|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400333|NCT00993421|P1|Participant Flow|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400334|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400335|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400336|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400337|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400338|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400339|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400340|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400341|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400342|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400343|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400344|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400345|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400346|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400347|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400348|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400349|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400350|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400351|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400352|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400353|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400354|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400355|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400356|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400357|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
419160|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
400358|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400359|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400360|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400361|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400362|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400363|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400364|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400365|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400366|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400367|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400368|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400369|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400370|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400371|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400372|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400373|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400374|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400375|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400376|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400377|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400378|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400379|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400380|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400381|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400382|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400383|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400384|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400385|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400386|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400698|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400387|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400388|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400389|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400390|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400391|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400392|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400393|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400394|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400395|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400396|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400397|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400398|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400399|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400400|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400401|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400402|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400403|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400404|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400405|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400406|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400407|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400408|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400409|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400410|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400411|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400412|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400413|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400414|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400507|NCT00993265|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
419161|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
400415|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400416|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400417|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400418|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400419|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400420|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400421|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400422|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400423|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400424|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400425|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400426|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400427|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400428|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400429|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400430|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400431|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400432|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400433|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400434|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400435|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400436|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400437|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400438|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400439|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400440|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400441|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400442|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400508|NCT00993265|B1|Baseline|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400443|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400444|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400445|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400446|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400447|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400448|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400449|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400450|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400451|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400452|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400453|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400454|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400455|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400456|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400457|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400458|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400459|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400460|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400461|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400462|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400463|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400464|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400465|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400466|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400467|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400468|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400469|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400470|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
400509|NCT00993265|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
419162|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
400471|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
400472|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400473|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400474|NCT00993421|E7|Reported Event|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400475|NCT00993421|E6|Reported Event|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400476|NCT00993421|E5|Reported Event|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400477|NCT00993421|E4|Reported Event|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
400478|NCT00993421|E3|Reported Event|Sibutramine (30mg)/Metoprolol (200mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).~Placebo LY377604: given orally, daily for 24 weeks."
400479|NCT00993421|E2|Reported Event|LY377604 (75 mg)|Given orally, daily for 24 weeks.
400480|NCT00993421|E1|Reported Event|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
400481|NCT00993317|B3|Baseline|Total|Total of all reporting groups
400482|NCT00993317|B2|Baseline|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400483|NCT00993317|B1|Baseline|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400484|NCT00993317|P2|Participant Flow|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400485|NCT00993317|P1|Participant Flow|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400486|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400487|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400488|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400489|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400490|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400491|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400492|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400493|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400494|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400495|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400496|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400497|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400498|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400499|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400500|NCT00993317|E2|Reported Event|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
400501|NCT00993317|E1|Reported Event|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
400502|NCT00993291|B1|Baseline|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
400503|NCT00993291|P1|Participant Flow|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
400504|NCT00993291|O1|Outcome|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
400505|NCT00993291|E1|Reported Event|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
400510|NCT00993265|P1|Participant Flow|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400511|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400512|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400513|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400514|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400515|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400516|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400517|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400518|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400519|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400520|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400521|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400522|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400523|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400524|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400525|NCT00993265|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
400526|NCT00993265|E1|Reported Event|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
400527|NCT00993200|B3|Baseline|Total|Total of all reporting groups
400528|NCT00993200|B2|Baseline|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
400529|NCT00993200|B1|Baseline|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
400530|NCT00993200|P2|Participant Flow|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
400531|NCT00993200|P1|Participant Flow|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
400532|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
400533|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
400534|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
400535|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
400536|NCT00993200|O2|Outcome|PERMIT|Warfarin management with use of gene-based warfarin dosing algorithm
400537|NCT00993200|O1|Outcome|Standard|Standard of care warfarin management
400595|NCT00993031|O2|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400538|NCT00993200|E2|Reported Event|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
400539|NCT00993200|E1|Reported Event|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
400540|NCT00993187|B3|Baseline|Total|Total of all reporting groups
400541|NCT00993187|B2|Baseline|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400542|NCT00993187|B1|Baseline|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400543|NCT00993187|P2|Participant Flow|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400544|NCT00993187|P1|Participant Flow|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400545|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400546|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400547|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400548|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400549|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400550|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400551|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400552|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400553|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400554|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400555|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400556|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400557|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400558|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400559|NCT00993187|E2|Reported Event|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
400560|NCT00993187|E1|Reported Event|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
400561|NCT00993148|B1|Baseline|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400562|NCT00993148|P1|Participant Flow|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400563|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400564|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400565|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400566|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400567|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400568|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400569|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400570|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400571|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400572|NCT00993148|E1|Reported Event|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
400573|NCT00993044|B1|Baseline|Dose Level 1, 2|
400574|NCT00993044|P1|Participant Flow|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
400575|NCT00993044|O1|Outcome|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
400576|NCT00993044|E2|Reported Event|Dose Level 2|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5"
400577|NCT00993044|E1|Reported Event|Dose Level 1|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5"
400578|NCT00993031|B3|Baseline|Total|Total of all reporting groups
400579|NCT00993031|B2|Baseline|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400580|NCT00993031|B1|Baseline|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400581|NCT00993031|P2|Participant Flow|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400582|NCT00993031|P1|Participant Flow|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400583|NCT00993031|O2|Outcome|Group B|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400584|NCT00993031|O1|Outcome|Group A|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400585|NCT00993031|O2|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400586|NCT00993031|O1|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400587|NCT00993031|O2|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400588|NCT00993031|O1|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400589|NCT00993031|O2|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400590|NCT00993031|O1|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400591|NCT00993031|O2|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400592|NCT00993031|O1|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400593|NCT00993031|O2|Outcome|Without Protease Inhibitor|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400640|NCT00992836|O1|Outcome|All Study Participants|All 155 study participants are included in this analysis.
400596|NCT00993031|O1|Outcome|With Protease Inhibitor|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400597|NCT00993031|E2|Reported Event|Group B|"ZDV 300mg/3TC 150mg/EFV 600mg~Efavirenz: 600mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400598|NCT00993031|E1|Reported Event|Group A|"ZDV 300mg/3TC 150mg/LPV 200mg/r 50mg~Lopinavir/ritonavir: LPV 200mg/r 50mg~Zidovudine: Zidovudine 300 mg~Lamivudine: Lamivudine 150 mg"
400599|NCT00992992|B1|Baseline|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400600|NCT00992992|P1|Participant Flow|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400601|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400602|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400603|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400604|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400605|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400606|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400641|NCT00992836|E1|Reported Event|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
400607|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400608|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400609|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400610|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400611|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400612|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400613|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400614|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400642|NCT00992784|B4|Baseline|Total|Total of all reporting groups
400643|NCT00992784|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400644|NCT00992784|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400645|NCT00992784|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400646|NCT00992784|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400647|NCT00992784|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400615|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400616|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400617|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400618|NCT00992992|E1|Reported Event|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
400619|NCT00992927|B3|Baseline|Total|Total of all reporting groups
400620|NCT00992927|B2|Baseline|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
400621|NCT00992927|B1|Baseline|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
400622|NCT00992927|P2|Participant Flow|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
400623|NCT00992927|P1|Participant Flow|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
400624|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
400625|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
400626|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
400627|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
400628|NCT00992927|E2|Reported Event|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
400629|NCT00992927|E1|Reported Event|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
400630|NCT00992836|B1|Baseline|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
400631|NCT00992836|P1|Participant Flow|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
400632|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
400633|NCT00992836|O1|Outcome|Influenza A (H1N1) 2009 Monovalent Vaccine|"All participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.~Influenza A (H1N1) 2009 monovalent vaccine: Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections"
400634|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
400635|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140, 142 and 138, for the analysis of antibody titers after the first and second vaccinations and after 6 months after the second vaccination, respectively.
400636|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 138, those who received both vaccinations and had nonmissing data.
400637|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140 and 142, for the analysis of antibody titers after the first and second vaccinations, respectively.
400638|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
400639|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
400648|NCT00992784|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400649|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400650|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400651|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400652|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400653|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400654|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400655|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400656|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400657|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400658|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400659|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400660|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400661|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400662|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400663|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400664|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400665|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400666|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400667|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400668|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400669|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400670|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400671|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400672|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400673|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400674|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400675|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400676|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400677|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400678|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400679|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400680|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400681|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400682|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400683|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400684|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400685|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400686|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400687|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400688|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400689|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400690|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400691|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400692|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400693|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400694|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400695|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400696|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400697|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400699|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400700|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400701|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400702|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400703|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400704|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400705|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400706|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400707|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400708|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400709|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400710|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400711|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400712|NCT00992784|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
400713|NCT00992784|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
400714|NCT00992784|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
400715|NCT00992719|B4|Baseline|Total|Total of all reporting groups
400716|NCT00992719|B3|Baseline|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400717|NCT00992719|B2|Baseline|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400718|NCT00992719|B1|Baseline|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400719|NCT00992719|P3|Participant Flow|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400720|NCT00992719|P2|Participant Flow|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400721|NCT00992719|P1|Participant Flow|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400722|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400723|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400724|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400725|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400726|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400727|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400728|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400729|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400730|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400731|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400732|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400733|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400734|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400735|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400736|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400737|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400738|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400739|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400740|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400741|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400742|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400743|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400744|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400745|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400746|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400747|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400748|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400749|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400750|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400751|NCT00992719|E3|Reported Event|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400752|NCT00992719|E2|Reported Event|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400753|NCT00992719|E1|Reported Event|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
400754|NCT00992602|B1|Baseline|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
400755|NCT00992602|P1|Participant Flow|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
400756|NCT00992602|O1|Outcome|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
400757|NCT00992602|O1|Outcome|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
400758|NCT00992602|E1|Reported Event|Treatment (Liposomal Cytarabine, High-dose Methotrexate)|"Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.~Consolidation phase:~2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.~Maintenance phase:~Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)~Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology."
400759|NCT00992589|B1|Baseline|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400760|NCT00992589|P4|Participant Flow|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400761|NCT00992589|P3|Participant Flow|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400762|NCT00992589|P2|Participant Flow|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400763|NCT00992589|P1|Participant Flow|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400764|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
400765|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400766|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400767|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400768|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
400769|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400770|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400771|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400772|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
400773|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400774|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400775|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400776|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
400777|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400778|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400779|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400780|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
400781|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400782|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400783|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400784|NCT00992589|O8|Outcome|Double-Blind Rabeprazole Sodium Total - Week 8|Rabeprazole Sodium capsules once daily in the morning.
400785|NCT00992589|O7|Outcome|Double-Blind Rabeprazole Sodium Total - Baseline|Rabeprazole Sodium capsules once daily in the morning.
400786|NCT00992589|O6|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
400787|NCT00992589|O5|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
400788|NCT00992589|O4|Outcome|Double-Blind Placebo - Week 8|Matching placebo capsules once daily in the morning.
400789|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
400790|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
400791|NCT00992589|O1|Outcome|Double-Blind Placebo - Baseline|Matching placebo capsules once daily in the morning.
400792|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
400793|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400794|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400795|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400796|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
400797|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400798|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400799|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400800|NCT00992589|E4|Reported Event|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400801|NCT00992589|E3|Reported Event|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
400802|NCT00992589|E2|Reported Event|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
400803|NCT00992589|E1|Reported Event|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
400804|NCT00992459|B3|Baseline|Total|Total of all reporting groups
400805|NCT00992459|B2|Baseline|Treatment Arm B|Patients randomized to receive HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 1) followed by NaPBA + HPN-100 placebo for 2 weeks (Treatment Period 2)
400806|NCT00992459|B1|Baseline|Treatment Arm A|Patients randomized to receive NaPBA + HPN 100 placebo for 2 weeks (Treatment Period 1) followed by HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 2)
400807|NCT00992459|P2|Participant Flow|Arm B|Subjects in Arm B were assigned to receive HPN-100 + NaPBA placebo for 2 weeks All patients in Arm B received NaPBA placebo (+ concomitant active HPN 100)
400808|NCT00992459|P1|Participant Flow|Arm A|Subjects in Arm A were assigned to receive NaPBA + HPN 100 placebo for 2 weeks All patients in Arm A received HPN100 placebo (+ concomitant active NaPBA)
400809|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400810|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400811|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400812|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400813|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400814|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400815|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400816|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400817|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400818|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400819|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400820|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400821|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400822|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400823|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400824|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400825|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400826|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400827|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
400828|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
400829|NCT00992459|E2|Reported Event|HPN-100|Patients received HPN-100
400830|NCT00992459|E1|Reported Event|NaPBA|Patients received NaPBA
400858|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400859|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400860|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400861|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400908|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400831|NCT00992446|B1|Baseline|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
400832|NCT00992446|P1|Participant Flow|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
400833|NCT00992446|O1|Outcome|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
400834|NCT00992446|O1|Outcome|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
400835|NCT00992446|E1|Reported Event|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
400836|NCT00992433|B3|Baseline|Total|Total of all reporting groups
400837|NCT00992433|B2|Baseline|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400838|NCT00992433|B1|Baseline|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400839|NCT00992433|P2|Participant Flow|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400840|NCT00992433|P1|Participant Flow|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400841|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400842|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400843|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400844|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400845|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400846|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400847|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400848|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400849|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400850|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400851|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400852|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400853|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400854|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400855|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400856|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400857|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
401063|NCT00992108|P1|Participant Flow|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
400862|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400863|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400864|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400865|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400866|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400867|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400868|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400869|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400870|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400871|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400872|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400873|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400874|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400875|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400876|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400877|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400878|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400879|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400880|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400881|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400882|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400883|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400884|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400885|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400886|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400887|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400888|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400889|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400890|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400891|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400892|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400893|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400894|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400895|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400896|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400897|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400898|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400899|NCT00992433|E2|Reported Event|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400900|NCT00992433|E1|Reported Event|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
400901|NCT00992407|B3|Baseline|Total|Total of all reporting groups
400902|NCT00992407|B2|Baseline|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400903|NCT00992407|B1|Baseline|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400904|NCT00992407|P2|Participant Flow|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400905|NCT00992407|P1|Participant Flow|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400906|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400907|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400909|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400910|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400911|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400912|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400913|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400914|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400915|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400916|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400917|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400918|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400919|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400920|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400921|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400922|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablets were administered orally as 0.5–10 mg daily up to Week 52.
400923|NCT00992407|O1|Outcome|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400924|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400925|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400926|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400927|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400928|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400929|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400930|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400931|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400932|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400933|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400934|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400935|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400936|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400937|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400938|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400939|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400940|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400941|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400942|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400943|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400944|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablet were administered orally as 0.5–10 mg daily up to Week 52.
400945|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400946|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
401064|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
400947|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400948|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400949|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400950|NCT00992407|E2|Reported Event|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
400951|NCT00992407|E1|Reported Event|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
400952|NCT00992394|B3|Baseline|Total|Total of all reporting groups
400953|NCT00992394|B2|Baseline|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400954|NCT00992394|B1|Baseline|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400955|NCT00992394|P2|Participant Flow|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400956|NCT00992394|P1|Participant Flow|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400957|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400958|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400959|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400960|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400961|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400962|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400963|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400964|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400965|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400966|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400967|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400968|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400969|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400970|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400971|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400972|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400973|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400974|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
401065|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
400975|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400976|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400977|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400978|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400979|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400980|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400981|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400982|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400983|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400984|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400985|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400986|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400987|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400988|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400989|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400990|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400991|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400992|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400993|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400994|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400995|NCT00992394|E2|Reported Event|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
400996|NCT00992394|E1|Reported Event|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
400997|NCT00992264|B17|Baseline|Total|Total of all reporting groups
400998|NCT00992264|B16|Baseline|Randomization Arm: 16|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [no].
400999|NCT00992264|B15|Baseline|Randomization Arm: 15|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [no].
401000|NCT00992264|B14|Baseline|Randomization Arm: 14|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [no].
401001|NCT00992264|B13|Baseline|Randomization Arm: 13|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [no].
401066|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
401067|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
401002|NCT00992264|B12|Baseline|Randomization Arm: 12|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [yes].
401003|NCT00992264|B11|Baseline|Randomization Arm: 11|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [yes].
401004|NCT00992264|B10|Baseline|Randomization Arm: 10|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
401005|NCT00992264|B9|Baseline|Randomization Arm: 9|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [yes].
401006|NCT00992264|B8|Baseline|Randomization Arm: 8|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [no].
401007|NCT00992264|B7|Baseline|Randomization Arm: 7|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [no].
401008|NCT00992264|B6|Baseline|Randomization Arm: 6|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [no].
401009|NCT00992264|B5|Baseline|Randomization Arm: 5|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [no].
401010|NCT00992264|B4|Baseline|Randomization Arm: 4|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [yes].
401011|NCT00992264|B3|Baseline|Randomization Arm: 3|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [yes].
401012|NCT00992264|B2|Baseline|Radndomization Arm: 2|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
401013|NCT00992264|B1|Baseline|Randomization Arm: 1|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [yes].
401014|NCT00992264|P16|Participant Flow|Randomization Arm 16|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [no]
401015|NCT00992264|P15|Participant Flow|Randomization Arm 15|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [no]
401016|NCT00992264|P14|Participant Flow|Randomization Arm 14|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [no]
401017|NCT00992264|P13|Participant Flow|Randomization Arm 13|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [no]
401018|NCT00992264|P12|Participant Flow|Randomization Arm 12|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [yes]
401019|NCT00992264|P11|Participant Flow|Randomization Arm 11|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [yes]
401020|NCT00992264|P10|Participant Flow|Randomization Arm 10|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [yes]
401021|NCT00992264|P9|Participant Flow|Randomization Arm 9|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [yes]
401022|NCT00992264|P8|Participant Flow|Randomization Arm 8|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [no]
401023|NCT00992264|P7|Participant Flow|Randomization Arm 7|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [no]
401024|NCT00992264|P6|Participant Flow|Randomization Arm 6|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [no]
401025|NCT00992264|P5|Participant Flow|Randomization Arm 5|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [no]
401026|NCT00992264|P4|Participant Flow|Randomization Arm 4|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [yes]
401027|NCT00992264|P3|Participant Flow|Randomization Arm 3|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [yes]
401028|NCT00992264|P2|Participant Flow|Randomization Arm 2|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [yes]
401029|NCT00992264|P1|Participant Flow|Randomization Arm 1|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [yes]
401030|NCT00992264|O4|Outcome|Proactive Emails|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
401031|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.~Persons in the comparison group could freely navigate the website."
401032|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.~Persons in the comparison group did not receive the testimonial content."
401033|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.~Persons in the comparison group received content written in a motivational message tone."
401034|NCT00992264|O4|Outcome|Proactive Outreach|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
401035|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.~Persons in the comparison group could freely navigate the website."
401036|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.~Persons in the comparison group did not receive the testimonial content."
401037|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.~Persons in the comparison group received content written in a motivational message tone."
401038|NCT00992264|E4|Reported Event|Proactive Outreach|"Email or No-Email communication~Persons are randomized to receive periodic email reminders to return to the intervention website or not."
401039|NCT00992264|E3|Reported Event|Navigation|"Dictated or Non-Dictated~Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking."
401040|NCT00992264|E2|Reported Event|Testimonials|"Testimonial or No Testimonial~Persons are randomized to receive a personally tailored testimonial or not."
401041|NCT00992264|E1|Reported Event|Message Tone|"Prescriptive or Motivational~Persons are randomized to receive intervention content written in either a prescriptive or motivational tone."
401042|NCT00992186|B1|Baseline|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401043|NCT00992186|P1|Participant Flow|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401044|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401045|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401046|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401047|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401048|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401049|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401050|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401051|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401052|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401053|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401054|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401055|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401056|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401057|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401058|NCT00992186|E1|Reported Event|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
401059|NCT00992108|B3|Baseline|Total|Total of all reporting groups
401060|NCT00992108|B2|Baseline|Botulinum|chemodenervation: botulinum toxin
401061|NCT00992108|B1|Baseline|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
401062|NCT00992108|P2|Participant Flow|Botulinum|chemodenervation: botulinum toxin
401068|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
401072|NCT00992108|E2|Reported Event|Botulinum|chemodenervation: botulinum toxin
401073|NCT00992108|E1|Reported Event|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
401074|NCT00992056|B3|Baseline|Total|Total of all reporting groups
401075|NCT00992056|B2|Baseline|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50 mg titrated to 100 mg
401076|NCT00992056|B1|Baseline|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then Nebivolol 5 mg titrated to 10 mg
401077|NCT00992056|P2|Participant Flow|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then nebivolol 5 mg titrated to 10 mg
401078|NCT00992056|P1|Participant Flow|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50mg titrated to 100 mg.
401079|NCT00992056|O2|Outcome|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
401080|NCT00992056|O1|Outcome|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
401081|NCT00992056|E2|Reported Event|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
401082|NCT00992056|E1|Reported Event|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
401083|NCT00992017|B1|Baseline|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
401084|NCT00992017|P1|Participant Flow|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
401085|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
401086|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
401087|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
401088|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
401089|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
401090|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received H1N1 vaccinations.
401091|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
401092|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
401093|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
401094|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women enrolled in the study.
401095|NCT00992017|E1|Reported Event|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
401096|NCT00991952|B3|Baseline|Total|Total of all reporting groups
401097|NCT00991952|B2|Baseline|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
401098|NCT00991952|B1|Baseline|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
401099|NCT00991952|P2|Participant Flow|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
401100|NCT00991952|P1|Participant Flow|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
401101|NCT00991952|O2|Outcome|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
401102|NCT00991952|O1|Outcome|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
401103|NCT00991952|E2|Reported Event|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
401104|NCT00991952|E1|Reported Event|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
401105|NCT00991939|B3|Baseline|Total|Total of all reporting groups
401106|NCT00991939|B2|Baseline|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401107|NCT00991939|B1|Baseline|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401108|NCT00991939|P2|Participant Flow|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401109|NCT00991939|P1|Participant Flow|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401110|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401111|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401112|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401113|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401114|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401115|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401116|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401117|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401118|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401119|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401120|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401121|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401122|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401123|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401124|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401125|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401126|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401127|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401128|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401129|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401130|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401131|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401132|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401133|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401134|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401135|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401136|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401137|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401165|NCT00991510|O3|Outcome|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
401316|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401138|NCT00991939|E2|Reported Event|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
401139|NCT00991939|E1|Reported Event|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
401140|NCT00991887|B3|Baseline|Total|Total of all reporting groups
401141|NCT00991887|B2|Baseline|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
401142|NCT00991887|B1|Baseline|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
401143|NCT00991887|P2|Participant Flow|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
401144|NCT00991887|P1|Participant Flow|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
401145|NCT00991887|O2|Outcome|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
401146|NCT00991887|O1|Outcome|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
401147|NCT00991887|E2|Reported Event|Radiation Therapy (XRT)|Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
401148|NCT00991887|E1|Reported Event|No Radiation Therapy (XRT)|This group will not receive radiation therapy after surgery.
401149|NCT00991809|B3|Baseline|Total|Total of all reporting groups
401150|NCT00991809|B2|Baseline|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
401151|NCT00991809|B1|Baseline|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
401152|NCT00991809|P2|Participant Flow|Diphenhydramine|"Subjects received a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
401153|NCT00991809|P1|Participant Flow|Alfentanil|"Subjects received a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg intramuscular(IM)"
401154|NCT00991809|O2|Outcome|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine: 25 mg IM"
401155|NCT00991809|O1|Outcome|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil: 15 mcg/kg IM"
401156|NCT00991809|O2|Outcome|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
401157|NCT00991809|O1|Outcome|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
401158|NCT00991809|E2|Reported Event|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
401159|NCT00991809|E1|Reported Event|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
401160|NCT00991510|B3|Baseline|Total|Total of all reporting groups
401161|NCT00991510|B2|Baseline|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
401162|NCT00991510|B1|Baseline|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
401163|NCT00991510|P2|Participant Flow|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
401164|NCT00991510|P1|Participant Flow|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
401166|NCT00991510|O2|Outcome|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401167|NCT00991510|O1|Outcome|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401168|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401169|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401170|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401171|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401172|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401173|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401174|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401175|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401176|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401177|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401178|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401179|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401180|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401181|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401182|NCT00991510|E3|Reported Event|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
401183|NCT00991510|E2|Reported Event|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401184|NCT00991510|E1|Reported Event|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
401185|NCT00991458|B4|Baseline|Total|Total of all reporting groups
401186|NCT00991458|B3|Baseline|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401187|NCT00991458|B2|Baseline|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401188|NCT00991458|B1|Baseline|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401189|NCT00991458|P3|Participant Flow|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401190|NCT00991458|P2|Participant Flow|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401191|NCT00991458|P1|Participant Flow|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401192|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401193|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401194|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401195|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401196|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401197|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401306|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
419163|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
401198|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401199|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401200|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401201|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401202|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401203|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401204|NCT00991458|E3|Reported Event|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401205|NCT00991458|E2|Reported Event|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401206|NCT00991458|E1|Reported Event|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
401207|NCT00991341|B3|Baseline|Total|Total of all reporting groups
401208|NCT00991341|B2|Baseline|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401209|NCT00991341|B1|Baseline|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401210|NCT00991341|P2|Participant Flow|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401211|NCT00991341|P1|Participant Flow|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401212|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401213|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401214|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401215|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401216|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401217|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401218|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401219|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401220|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401221|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401307|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily in any intervention period.
401308|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401222|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401223|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401224|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401225|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401226|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401227|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401228|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401229|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401230|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401231|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401232|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401233|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401234|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401235|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401236|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401237|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401238|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401239|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401240|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401241|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401242|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401309|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401310|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401243|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401244|NCT00991341|E2|Reported Event|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401245|NCT00991341|E1|Reported Event|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
401246|NCT00991302|B3|Baseline|Total|Total of all reporting groups
401247|NCT00991302|B2|Baseline|Standard Care|Participants received standard care.
401248|NCT00991302|B1|Baseline|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401249|NCT00991302|P2|Participant Flow|Standard Care|Participants received standard care.
401250|NCT00991302|P1|Participant Flow|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401251|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
401252|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401253|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
401254|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401255|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
401256|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401257|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
401258|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401259|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
401260|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401261|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
401262|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401263|NCT00991302|E2|Reported Event|Standard Care|Participants received standard care.
401264|NCT00991302|E1|Reported Event|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
401265|NCT00991289|B1|Baseline|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401266|NCT00991289|P1|Participant Flow|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401267|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401268|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401269|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401270|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401271|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401272|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401273|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401274|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401275|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401276|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401277|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401278|NCT00991289|E1|Reported Event|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
401279|NCT00991276|B7|Baseline|Total|Total of all reporting groups
401280|NCT00991276|B6|Baseline|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401281|NCT00991276|B5|Baseline|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401282|NCT00991276|B4|Baseline|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401283|NCT00991276|B3|Baseline|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401284|NCT00991276|B2|Baseline|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401311|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401312|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401313|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401314|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401315|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401285|NCT00991276|B1|Baseline|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401286|NCT00991276|P6|Participant Flow|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401287|NCT00991276|P5|Participant Flow|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401288|NCT00991276|P4|Participant Flow|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401289|NCT00991276|P3|Participant Flow|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401290|NCT00991276|P2|Participant Flow|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401291|NCT00991276|P1|Participant Flow|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
401292|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401293|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401294|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401295|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401296|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401297|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401298|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401299|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401300|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401301|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401302|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401303|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401304|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401305|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401317|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401318|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401319|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401320|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401321|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401322|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401323|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401324|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401325|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401326|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401327|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401328|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401329|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401330|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401331|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401332|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401333|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401334|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401335|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401336|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401337|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401338|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401339|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401340|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401341|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401342|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401343|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401344|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401345|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401346|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401347|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401348|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401349|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401350|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401351|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401352|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401353|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401354|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401355|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401356|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401357|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401358|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401359|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401360|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401361|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401362|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401363|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401364|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401365|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401366|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401367|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401368|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401369|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401370|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401371|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401372|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401373|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401374|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401375|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401376|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401377|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401378|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401379|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401380|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401381|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401382|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
401383|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401384|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401385|NCT00991276|E3|Reported Event|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in any of the intervention period.
401386|NCT00991276|E2|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
401387|NCT00991276|E1|Reported Event|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
401388|NCT00991185|B1|Baseline|Vancomycin|children that received vancomycin per standard of care
401389|NCT00991185|P1|Participant Flow|Vancomycin|children that received vancomycin per standard of care
401390|NCT00991185|O1|Outcome|Vancomycin|children that received vancomycin per standard of care
401391|NCT00991185|E1|Reported Event|Vancomycin|children that received vancomycin per standard of care
401392|NCT00991081|B3|Baseline|Total|Total of all reporting groups
401393|NCT00991081|B2|Baseline|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
401394|NCT00991081|B1|Baseline|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
401395|NCT00991081|P3|Participant Flow|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
401396|NCT00991081|P2|Participant Flow|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
401397|NCT00991081|P1|Participant Flow|Formative Interviews|"Phase 1 involved formative research to develop and refine a patient-centered, theoretically grounded behavioral intervention for delivering genetically-tailored smoking cessation treatment. We convened a panel of doctorate level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal and social implications of genetics research; genetic literacy; patient-clinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF and evaluation.~Next, smokers were asked about their familiarity with genetic concepts (e.g., DNA, genes), understanding of the roles genes play in smoking behavior and treatment response, reaction to the concept of genetically-tailoring pharmacotherapy, familiarity with the Genetic Information Nondiscrimination Act, concerns about privacy of genetic information, and interest in genetically-tailored treatment. Interviews were continued until response saturation was achieved (n = 10)."
401398|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401399|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401400|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401401|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401402|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401403|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401404|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401405|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401406|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401407|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401408|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401409|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401410|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401411|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401412|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401455|NCT00990821|P7|Participant Flow|Part III, Panel 2|40 mg MK-0517 (non-PS80)
401413|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401414|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401415|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401416|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401417|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401418|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401419|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401420|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401421|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401422|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401423|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401424|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401425|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401426|NCT00991081|E2|Reported Event|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401427|NCT00991081|E1|Reported Event|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
401428|NCT00990964|B1|Baseline|Attain Family Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
401429|NCT00990964|P1|Participant Flow|Attain Family Left Heart Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
401430|NCT00990964|O1|Outcome|Attain Family Lead Attempt, Any Catheter|Subjects who were attempted with Attain Family delivery catheters or Attain Family left-heart leads were included in this analysis.
401431|NCT00990964|O1|Outcome|Attain Family Lead and Catheter Attempt|Subjects who were attempted with an Attain Family left-heart lead after successful coronary sinus (CS) cannulation with an Attain Family catheter were included in this analysis as well as subjects who had unsuccessful CS cannulation with an Attain Family delivery catheter.
401432|NCT00990964|E1|Reported Event|Attain Family Lead|All new and/or worsening adverse events related to the left-heart leads and left-heart lead delivery catheters were collected through the 3 month visit. Event collection started once the subject enrolled in the study and underwent a left-heart lead implant attempt.
401433|NCT00990821|B15|Baseline|Total|Total of all reporting groups
401434|NCT00990821|B14|Baseline|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
401435|NCT00990821|B13|Baseline|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
401436|NCT00990821|B12|Baseline|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
401437|NCT00990821|B11|Baseline|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
401438|NCT00990821|B10|Baseline|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
401439|NCT00990821|B9|Baseline|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
401440|NCT00990821|B8|Baseline|Part IV|40 mg MK-0517 (non-PS80 formulation)
401441|NCT00990821|B7|Baseline|Part III, Panel 2|40 mg MK-0517 (non-PS80)
401442|NCT00990821|B6|Baseline|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
401443|NCT00990821|B5|Baseline|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
401444|NCT00990821|B4|Baseline|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
401445|NCT00990821|B3|Baseline|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
401446|NCT00990821|B2|Baseline|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
401447|NCT00990821|B1|Baseline|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
401448|NCT00990821|P14|Participant Flow|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
401449|NCT00990821|P13|Participant Flow|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
401450|NCT00990821|P12|Participant Flow|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
401451|NCT00990821|P11|Participant Flow|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
401452|NCT00990821|P10|Participant Flow|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
401453|NCT00990821|P9|Participant Flow|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
401454|NCT00990821|P8|Participant Flow|Part IV|40 mg MK-0517 (non-PS80 formulation)
401456|NCT00990821|P6|Participant Flow|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
401457|NCT00990821|P5|Participant Flow|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
401458|NCT00990821|P4|Participant Flow|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
401459|NCT00990821|P3|Participant Flow|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
401460|NCT00990821|P2|Participant Flow|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
401461|NCT00990821|P1|Participant Flow|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
401462|NCT00990821|O3|Outcome|MK-0517 (115 mg)|115 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
401463|NCT00990821|O2|Outcome|MK-0517 (100 mg)|100 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
401464|NCT00990821|O1|Outcome|Aprepitant (125 mg)|A single oral dose with an Aprepitant capsule
401465|NCT00990821|E12|Reported Event|2 mg Midazolam|Midazolam administered as a single oral solution
401466|NCT00990821|E11|Reported Event|125 mg Aprepitant|Aprepitant administered as a single oral capsule
401467|NCT00990821|E10|Reported Event|40 mg Aprepitant|Aprepitant administered by a single oral capsule
401468|NCT00990821|E9|Reported Event|Placebo|Placebo matching MK-0517 (PS80 or non-PS80)
401469|NCT00990821|E8|Reported Event|150 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
401470|NCT00990821|E7|Reported Event|100 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
401471|NCT00990821|E6|Reported Event|40 mg MK-0517 (Non-PS80)|MK-0517, non-PS80 formulation, administered with a single IV administration
401472|NCT00990821|E5|Reported Event|150 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
401473|NCT00990821|E4|Reported Event|115 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
401474|NCT00990821|E3|Reported Event|100 mg MK-0517 (PS80) + 2 mg Midazolam|PS80 formulation, administered with a single IV administration and a single oral administration of midazolam
401475|NCT00990821|E2|Reported Event|100 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
401476|NCT00990821|E1|Reported Event|90 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
401477|NCT00990782|B1|Baseline|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
401478|NCT00990782|P1|Participant Flow|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
401479|NCT00990782|O1|Outcome|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
401480|NCT00990782|O1|Outcome|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
401481|NCT00990782|E1|Reported Event|PillCam ESO Capsule Endoscope|"All patients receive capsule endoscopy before and after RFA procedure.~PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation."
401482|NCT00990769|B3|Baseline|Total|Total of all reporting groups
401483|NCT00990769|B2|Baseline|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
401484|NCT00990769|B1|Baseline|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
401485|NCT00990769|P2|Participant Flow|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
401486|NCT00990769|P1|Participant Flow|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
401487|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
401488|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
401489|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
401490|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
401491|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
401492|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
401493|NCT00990769|E2|Reported Event|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
401494|NCT00990769|E1|Reported Event|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
401495|NCT00990704|B3|Baseline|Total|Total of all reporting groups
401496|NCT00990704|B2|Baseline|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401497|NCT00990704|B1|Baseline|Paricalcitol|2 mcg with incremental of 1 mcg
401498|NCT00990704|P2|Participant Flow|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401499|NCT00990704|P1|Participant Flow|Paricalcitol|2 mcg with incremental of 1 mcg
401500|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401501|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401502|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401503|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401504|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401505|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401506|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401507|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401508|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401509|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401510|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401511|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401512|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401513|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401514|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401515|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
401516|NCT00990704|E2|Reported Event|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
401517|NCT00990704|E1|Reported Event|Paricalcitol|2 mcg with incremental of 1 mcg
401518|NCT00990652|B1|Baseline|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
401519|NCT00990652|P1|Participant Flow|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
401520|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
401521|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
401522|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
401523|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
401524|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
401525|NCT00990652|E1|Reported Event|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
401526|NCT00990561|B3|Baseline|Total|Total of all reporting groups
401527|NCT00990561|B2|Baseline|Ultravate Once a Day|Ultravate ointment applied once daily
401528|NCT00990561|B1|Baseline|Ultravate Twice a Day|
401529|NCT00990561|P4|Participant Flow|No Treatment|
401530|NCT00990561|P3|Participant Flow|Lac-Hydrin Topically Twice a Day|
401531|NCT00990561|P2|Participant Flow|Once Daily Topical Ultravate Ointment + LacHydrin Lotion|
401532|NCT00990561|P1|Participant Flow|Twice Daily Topical Ultravate Ointment + LacHyrin Twice Daily|
401533|NCT00990561|O2|Outcome|Ultravate 0.05% Ointment Once Daily|Ultravate one daily to affected area.
401534|NCT00990561|O1|Outcome|Ultravate 0.05% Ointment Twice Daily|Ultravate twice daily to affected area.
401535|NCT00990561|E2|Reported Event|Ultravate Once a Day|Ultravate ointment applied once daily
401536|NCT00990561|E1|Reported Event|Ultravate Twice a Day|
401537|NCT00990509|B3|Baseline|Total|Total of all reporting groups
401538|NCT00990509|B2|Baseline|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401539|NCT00990509|B1|Baseline|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401540|NCT00990509|P2|Participant Flow|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401541|NCT00990509|P1|Participant Flow|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401542|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401543|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401544|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401545|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401546|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401547|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401548|NCT00990509|E2|Reported Event|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401549|NCT00990509|E1|Reported Event|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
401550|NCT00990340|B3|Baseline|Total|Total of all reporting groups
401551|NCT00990340|B2|Baseline|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
401552|NCT00990340|B1|Baseline|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
401553|NCT00990340|P2|Participant Flow|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
401554|NCT00990340|P1|Participant Flow|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
401555|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
401556|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
401557|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
401558|NCT00990340|O1|Outcome|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
401559|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
401560|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
401561|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
401562|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
401563|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
401564|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
401565|NCT00990340|E2|Reported Event|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
401566|NCT00990340|E1|Reported Event|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
401567|NCT00990288|B3|Baseline|Total|Total of all reporting groups
401568|NCT00990288|B2|Baseline|Control|No intervention.
401569|NCT00990288|B1|Baseline|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401570|NCT00990288|P2|Participant Flow|Control|No intervention.
401571|NCT00990288|P1|Participant Flow|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401572|NCT00990288|O2|Outcome|Control|No intervention.
401573|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401574|NCT00990288|O2|Outcome|Control|No intervention.
401575|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401576|NCT00990288|O2|Outcome|Control|No intervention.
401577|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401578|NCT00990288|O2|Outcome|Control|No intervention.
401579|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401580|NCT00990288|O2|Outcome|Control|No intervention.
401581|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401582|NCT00990288|O2|Outcome|Control|No intervention.
401583|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401584|NCT00990288|O2|Outcome|Control|No intervention.
401585|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401586|NCT00990288|O2|Outcome|Control|No intervention.
401587|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401588|NCT00990288|O2|Outcome|Control|No intervention.
401589|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401590|NCT00990288|O2|Outcome|Control|No intervention.
401591|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401592|NCT00990288|O2|Outcome|Control|No intervention.
401593|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401594|NCT00990288|O2|Outcome|Control|No intervention.
401595|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401596|NCT00990288|O2|Outcome|Control|No intervention.
401597|NCT00990288|O1|Outcome|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401598|NCT00990288|E2|Reported Event|Control|No intervention.
401599|NCT00990288|E1|Reported Event|Hemostatic Matrix|2 vials of Floseal applied once at the end of surgery
401600|NCT00990184|B1|Baseline|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
401601|NCT00990184|P1|Participant Flow|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
401602|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline (end of two week placebo run in period)
401603|NCT00990184|O1|Outcome|Colesevelam 3.75 g Daily|Medication used to treat people with increased cholesterol levels
401604|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline
401605|NCT00990184|E1|Reported Event|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
401606|NCT00990106|B3|Baseline|Total|Total of all reporting groups
401607|NCT00990106|B2|Baseline|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
401608|NCT00990106|B1|Baseline|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
401609|NCT00990106|P2|Participant Flow|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
401610|NCT00990106|P1|Participant Flow|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
401611|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
401698|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401612|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
401613|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
401614|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
401615|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
401616|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
401617|NCT00990106|E2|Reported Event|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
401618|NCT00990106|E1|Reported Event|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
401619|NCT00990093|B1|Baseline|Entire Study Population|
401620|NCT00990093|P2|Participant Flow|B: First Standard Catheter Then Test Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
401621|NCT00990093|P1|Participant Flow|A: First Test Catheter Then Standard Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
401622|NCT00990093|O2|Outcome|Standard Catheter|SpeediCath Catheter
401623|NCT00990093|O1|Outcome|Test Catheter|SpeediCath Compact Male Catheter
401624|NCT00990093|E2|Reported Event|Standard Catheter|SpeediCath, CH 12 hydrophilic coated intermittent catheter
401625|NCT00990093|E1|Reported Event|Test Catheter|SpeediCath Compact Male
401626|NCT00989989|B4|Baseline|Total|Total of all reporting groups
401627|NCT00989989|B3|Baseline|Laser Control|Active laser treatment plus sham intravitreal injections.
401628|NCT00989989|B2|Baseline|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401629|NCT00989989|B1|Baseline|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401630|NCT00989989|P3|Participant Flow|Laser Control|Active laser treatment plus sham intravitreal injections.
401631|NCT00989989|P2|Participant Flow|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401632|NCT00989989|P1|Participant Flow|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401633|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401634|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401635|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401636|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401637|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401638|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401639|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401640|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401641|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401642|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401643|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401644|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401645|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401646|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401647|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401648|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401649|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401650|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401651|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401652|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
402909|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
401653|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401654|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401655|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401656|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401657|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401658|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401659|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401660|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401661|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401662|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401663|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
401664|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401665|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401666|NCT00989989|E3|Reported Event|Laser Control|Active laser treatment plus sham intravitreal injections.
401667|NCT00989989|E2|Reported Event|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
401668|NCT00989989|E1|Reported Event|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
401669|NCT00989950|B5|Baseline|Total|Total of all reporting groups
401670|NCT00989950|B4|Baseline|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401671|NCT00989950|B3|Baseline|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401672|NCT00989950|B2|Baseline|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401673|NCT00989950|B1|Baseline|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401674|NCT00989950|P4|Participant Flow|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401675|NCT00989950|P3|Participant Flow|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401676|NCT00989950|P2|Participant Flow|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401677|NCT00989950|P1|Participant Flow|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401678|NCT00989950|O4|Outcome|12 hr Wear|Result for all patients when patch worn for 12 hrs/day
401679|NCT00989950|O3|Outcome|11 hr Wear|Result for all patients when patch worn for 11 hrs/day
401680|NCT00989950|O2|Outcome|10 hr Wear|Result for all patients when patch worn for 10 hrs/day
401681|NCT00989950|O1|Outcome|9 hr Wear|Result for all patients when patch worn for 9 hrs/day
401682|NCT00989950|E4|Reported Event|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401683|NCT00989950|E3|Reported Event|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401684|NCT00989950|E2|Reported Event|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401685|NCT00989950|E1|Reported Event|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
401686|NCT00989911|B1|Baseline|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
401687|NCT00989911|P1|Participant Flow|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
401688|NCT00989911|O1|Outcome|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
401689|NCT00989911|E1|Reported Event|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
401690|NCT00989833|B4|Baseline|Total|Total of all reporting groups
401691|NCT00989833|B3|Baseline|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401692|NCT00989833|B2|Baseline|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401693|NCT00989833|B1|Baseline|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401694|NCT00989833|P3|Participant Flow|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401695|NCT00989833|P2|Participant Flow|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401696|NCT00989833|P1|Participant Flow|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401697|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
419164|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
401699|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401700|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401701|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401702|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401703|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401704|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401705|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401706|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401707|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401708|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401709|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401710|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401711|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401712|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401713|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401714|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401715|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401716|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401717|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401718|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401719|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401720|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401721|NCT00989833|E3|Reported Event|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
401722|NCT00989833|E2|Reported Event|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
401723|NCT00989833|E1|Reported Event|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
401724|NCT00989781|B3|Baseline|Total|Total of all reporting groups
401725|NCT00989781|B2|Baseline|Normal Women|"Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above."
401726|NCT00989781|B1|Baseline|PCOS Women|"Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above."
401727|NCT00989781|P2|Participant Flow|Normal Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401728|NCT00989781|P1|Participant Flow|PCOS Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401729|NCT00989781|O3|Outcome|Normal Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
402855|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
401730|NCT00989781|O2|Outcome|HR-PCOS Women|"PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401731|NCT00989781|O1|Outcome|NR-PCOS Women|"PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401732|NCT00989781|O3|Outcome|Normal Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401733|NCT00989781|O2|Outcome|HR-PCOS Women|"PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401734|NCT00989781|O1|Outcome|NR-PCOS Women|"PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401735|NCT00989781|O3|Outcome|Normal Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401736|NCT00989781|O2|Outcome|HR-PCOS Women|"PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401737|NCT00989781|O1|Outcome|NR-PCOS Women|"PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401738|NCT00989781|O3|Outcome|Normal Women|"Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401820|NCT00989287|O3|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401821|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401739|NCT00989781|O2|Outcome|HR-PCOS Women|"PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401740|NCT00989781|O1|Outcome|NR-PCOS Women|"PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT."
401741|NCT00989781|E2|Reported Event|Normal Women|"Each subject will undergo pelvic 3D ultrasound and an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals, the r-hCG stimulation test and OGTT will be repeated as described above.~3-D Ultrasound: One time pelvic ultrasound~recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards~Recombinant human follicle stimulati"
401742|NCT00989781|E1|Reported Event|PCOS Women|"Each subject will undergo pelvic 3D ultrasound and an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).~After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given before ACTH.~After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals, the r-hCG stimulation test and OGTT will be repeated as described above.~3-D Ultrasound: One time pelvic ultrasound~recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards~Recombinant human follicle stimulating"
401743|NCT00989768|B1|Baseline|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
401744|NCT00989768|P1|Participant Flow|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
401745|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered two units to the other side of frontal region
401746|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
401747|NCT00989768|O2|Outcome|Botox ® 2U|Two units of Botox® was administered to the other side of the frontal region.
401748|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
401749|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
401750|NCT00989768|O1|Outcome|Dysport® 5U|Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
401751|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
401752|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
401753|NCT00989768|E1|Reported Event|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
401754|NCT00989664|B1|Baseline|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401755|NCT00989664|P1|Participant Flow|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401756|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401757|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401758|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401759|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401760|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401761|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401762|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401763|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401764|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
402910|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
401765|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401766|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401767|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401768|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401769|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401770|NCT00989664|O2|Outcome|LQCR|Participants treated with at least two chemotherapy regimens before enrolling in study BEX104504
401771|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401772|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401773|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401822|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401823|NCT00989287|O6|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
402266|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
401774|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401775|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401776|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401777|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
401778|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401779|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
401780|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401781|NCT00989664|E1|Reported Event|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
401782|NCT00989586|B3|Baseline|Total|Total of all reporting groups
401783|NCT00989586|B2|Baseline|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
401784|NCT00989586|B1|Baseline|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
401903|NCT00989235|B1|Baseline|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401785|NCT00989586|P2|Participant Flow|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
401786|NCT00989586|P1|Participant Flow|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
401787|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
401788|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
401789|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
401790|NCT00989586|O2|Outcome|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
401791|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
401792|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
401793|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
401794|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
401795|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
401796|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
401797|NCT00989586|E1|Reported Event|All Patients From Phase I and Phase II|Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment.
401798|NCT00989287|B3|Baseline|Total|Total of all reporting groups
401799|NCT00989287|B2|Baseline|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401800|NCT00989287|B1|Baseline|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401801|NCT00989287|P2|Participant Flow|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401802|NCT00989287|P1|Participant Flow|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401803|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401804|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401805|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401806|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401807|NCT00989287|O2|Outcome|GSK2340269A Group|New Group 2 Description
401808|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401809|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401810|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401811|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401812|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401813|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401814|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401815|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401816|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401817|NCT00989287|O6|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401818|NCT00989287|O5|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401819|NCT00989287|O4|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
402911|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
401824|NCT00989287|O5|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401825|NCT00989287|O4|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401826|NCT00989287|O3|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401827|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401828|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401829|NCT00989287|O6|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401830|NCT00989287|O5|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401831|NCT00989287|O4|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401832|NCT00989287|O3|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401833|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401834|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401835|NCT00989287|O8|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401836|NCT00989287|O7|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401837|NCT00989287|O6|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401838|NCT00989287|O5|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401839|NCT00989287|O4|Outcome|GSK2340269A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401840|NCT00989287|O3|Outcome|GSK2340272A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401841|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401842|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401843|NCT00989287|O6|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401844|NCT00989287|O5|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401845|NCT00989287|O4|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401846|NCT00989287|O3|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401847|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401848|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401849|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
402912|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
401850|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401851|NCT00989287|O6|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401852|NCT00989287|O5|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401853|NCT00989287|O4|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401854|NCT00989287|O3|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401855|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401856|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401857|NCT00989287|O6|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401858|NCT00989287|O5|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401859|NCT00989287|O4|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401860|NCT00989287|O3|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401861|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401862|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401863|NCT00989287|O6|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401864|NCT00989287|O5|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401865|NCT00989287|O4|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401866|NCT00989287|O3|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401867|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401868|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401869|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401870|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401871|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401872|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401873|NCT00989287|O8|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401874|NCT00989287|O7|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401875|NCT00989287|O6|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401876|NCT00989287|O5|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401877|NCT00989287|O4|Outcome|GSK2340269A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401878|NCT00989287|O3|Outcome|GSK2340272A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401879|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401880|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401881|NCT00989287|O8|Outcome|GSK2340269A (51-60y)|Healthy male or female adults, 41 to 60 years (51-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401882|NCT00989287|O7|Outcome|GSK2340272A (51-60y)|Healthy male or female adults, 51 to 60 years (15-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401883|NCT00989287|O6|Outcome|GSK2340269A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401884|NCT00989287|O5|Outcome|GSK2340272A (41-50y)|Healthy male or female adults, 41 to 50 years (41-50y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401885|NCT00989287|O4|Outcome|GSK2340269A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401886|NCT00989287|O3|Outcome|GSK2340272A (41-60y)|Healthy male or female adults, 41 to 60 years (41-60y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401887|NCT00989287|O2|Outcome|GSK2340269A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401888|NCT00989287|O1|Outcome|GSK2340272A (18-40y)|Healthy male or female adults, 18 to 40 years (18-40y) of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401889|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401890|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401891|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401892|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401893|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401894|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401895|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401896|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401897|NCT00989287|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401898|NCT00989287|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401899|NCT00989287|E2|Reported Event|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401900|NCT00989287|E1|Reported Event|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
401901|NCT00989235|B3|Baseline|Total|Total of all reporting groups
401902|NCT00989235|B2|Baseline|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401904|NCT00989235|P2|Participant Flow|Abatacept (5 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
401905|NCT00989235|P1|Participant Flow|Abatacept (10 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
401906|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401907|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401908|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401909|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401910|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401911|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401912|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401913|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401914|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401915|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401916|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401917|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401918|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401919|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401920|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401921|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401922|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
401923|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
401924|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401925|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401926|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401927|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401928|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401929|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401930|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401931|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401932|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401933|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401934|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401935|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401936|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401937|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401938|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401939|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401940|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401941|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401942|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401943|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401944|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
401945|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
401946|NCT00989235|E3|Reported Event|Abatacept 10mg/kg (Open-Label)|
401947|NCT00989235|E2|Reported Event|Abatacept 10mg/kg (ST)|
401948|NCT00989235|E1|Reported Event|Abatacept 5mg/kg (ST)|
401949|NCT00989196|B1|Baseline|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
401950|NCT00989196|P2|Participant Flow|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
402913|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
401951|NCT00989196|P1|Participant Flow|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401952|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
401953|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
401954|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401955|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401956|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401957|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401958|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401959|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401960|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401961|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401962|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401963|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401964|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401965|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
401966|NCT00989196|O2|Outcome|Kogenate FS|Kogenate FS 50 IU/kg for PK dose
401967|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII 50 IU/kg for PK dose
401968|NCT00989196|E1|Reported Event|Human cl rhFVIII and Kogenate FS|All participants. Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK period. After the PK period all participants received Human-cl rhFVIII in the treatment period.
401969|NCT00989157|B3|Baseline|Total|Total of all reporting groups
401970|NCT00989157|B2|Baseline|Control|Subjects matched to the bariatric subjects via BMI, age and gender
401971|NCT00989157|B1|Baseline|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
401972|NCT00989157|P2|Participant Flow|Bariatric|One year post surgery
401973|NCT00989157|P1|Participant Flow|Control|Matched to bariatric subject via BMI, age and gender
401974|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
401975|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
401976|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
401977|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
401978|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
401979|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
401980|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
401981|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
401982|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender
401983|NCT00989157|O1|Outcome|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
401984|NCT00989157|E2|Reported Event|Control|Subjects matched to the bariatric subjects via BMI, age and gender
401985|NCT00989157|E1|Reported Event|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
401986|NCT00989092|B3|Baseline|Total|Total of all reporting groups
402047|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402110|NCT00988832|E1|Reported Event|INFLIXIMAB, RECOMBINANT|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
401987|NCT00989092|B2|Baseline|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
401988|NCT00989092|B1|Baseline|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
401989|NCT00989092|P2|Participant Flow|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
401990|NCT00989092|P1|Participant Flow|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
401991|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
401992|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
401993|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
401994|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
401995|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
401996|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
401997|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
401998|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
401999|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402000|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402111|NCT00988637|B3|Baseline|Total|Total of all reporting groups
402001|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402002|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402003|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402004|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402005|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402006|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402007|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402008|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402009|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402010|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402011|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402012|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402013|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402014|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402914|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402015|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402016|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402017|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
402018|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
402019|NCT00989092|E3|Reported Event|Observation Arm Not Treated|Participants in the observation group who did not receive any darbepoetin alfa treatment.
402020|NCT00989092|E2|Reported Event|Observation Arm Treated|Participants in the observation group who received darbepoetin alfa, initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. Adverse events for participants in this group could have been reported at any time during the study; and therefore, may have occurred before darbepoetin alfa administration.
402021|NCT00989092|E1|Reported Event|Treatment Arm|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
402022|NCT00989014|B5|Baseline|Total|Total of all reporting groups
402023|NCT00989014|B4|Baseline|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
402024|NCT00989014|B3|Baseline|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
402025|NCT00989014|B2|Baseline|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
402026|NCT00989014|B1|Baseline|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
402027|NCT00989014|P4|Participant Flow|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
402028|NCT00989014|P3|Participant Flow|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
402029|NCT00989014|P2|Participant Flow|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
402030|NCT00989014|P1|Participant Flow|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
402031|NCT00989014|O4|Outcome|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
402032|NCT00989014|O3|Outcome|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
402033|NCT00989014|O2|Outcome|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
402034|NCT00989014|O1|Outcome|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
402035|NCT00989014|E4|Reported Event|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
402036|NCT00989014|E3|Reported Event|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
402037|NCT00989014|E2|Reported Event|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
402038|NCT00989014|E1|Reported Event|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
402039|NCT00988884|B3|Baseline|Total|Total of all reporting groups
402040|NCT00988884|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402041|NCT00988884|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402042|NCT00988884|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402043|NCT00988884|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402044|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402045|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402046|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
419165|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
402048|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402049|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402050|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402051|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402052|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402053|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402054|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402055|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402056|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402057|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402058|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402059|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402060|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402061|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402062|NCT00988884|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
402063|NCT00988884|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
402064|NCT00988858|B1|Baseline|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402065|NCT00988858|P1|Participant Flow|LY2603618 and Pemetrexed|"LY2603618: 150 milligram per square meter mg/m^2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression~Pemetrexed: 500mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402066|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402067|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402068|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402069|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402109|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402383|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402070|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402071|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402072|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402073|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402074|NCT00988858|O1|Outcome|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402075|NCT00988858|E1|Reported Event|LY2603618 and Pemetrexed|"LY2603618: 150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression~Pemetrexed: 500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression"
402076|NCT00988832|B1|Baseline|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
402077|NCT00988832|P1|Participant Flow|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
402078|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402079|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402080|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402081|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402082|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402083|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402084|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402085|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402086|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402087|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402088|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402089|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402090|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402091|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402092|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402093|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402094|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402095|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402096|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402097|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402098|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402099|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402100|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402101|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402102|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402103|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402104|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402105|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
402106|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
402107|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
402108|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
402915|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402112|NCT00988637|B2|Baseline|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402113|NCT00988637|B1|Baseline|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402114|NCT00988637|P2|Participant Flow|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402115|NCT00988637|P1|Participant Flow|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402116|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402117|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402118|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402119|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402120|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402121|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402122|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402123|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402124|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402125|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402126|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402127|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402128|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402129|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402130|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402131|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402132|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402133|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402134|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402135|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402136|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402137|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402138|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402139|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402140|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402141|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402142|NCT00988637|E2|Reported Event|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
402143|NCT00988637|E1|Reported Event|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
402144|NCT00988533|B1|Baseline|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402145|NCT00988533|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402146|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402147|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402148|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402149|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402150|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402151|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402152|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402153|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402154|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402155|NCT00988533|E1|Reported Event|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
402156|NCT00988442|B3|Baseline|Total|Total of all reporting groups
402157|NCT00988442|B2|Baseline|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402158|NCT00988442|B1|Baseline|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402159|NCT00988442|P2|Participant Flow|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402160|NCT00988442|P1|Participant Flow|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402161|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Usual ACTG site care."
402162|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Usual ACTG site care."
402163|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Usual ACTG site care."
402164|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Usual ACTG site care."
402165|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Usual ACTG site care."
402166|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Usual ACTG site care."
402167|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402168|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402169|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402170|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402171|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402172|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402173|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402174|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402175|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402176|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402177|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402178|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402179|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402180|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402181|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402182|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402183|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402184|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402185|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402186|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402187|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this may vary by study site."
402188|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402189|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402209|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402916|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402190|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402191|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402192|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402193|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402194|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402195|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402196|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402197|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402198|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402199|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402200|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402201|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402202|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402203|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402204|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402205|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402206|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402207|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402208|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402210|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402211|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402212|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402213|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402214|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402215|NCT00988442|O2|Outcome|Standard Care|"Participants received care as usual.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402216|NCT00988442|O1|Outcome|Enhanced Nursing Telephone Support With Standard Care|"Participants received enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site."
402217|NCT00988442|E2|Reported Event|Standard Care|"Participants will receive care as usual.~Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site."
402218|NCT00988442|E1|Reported Event|Enhanced Nursing Telephone Support With Standard Care|"Participants will receive enhanced nursing telephone support plus care as usual.~Enhanced nursing telephone support: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses may schedule more frequent calls at their discretion. Calls will provide information, motivational enhancement, problem-solving skills, and affective support.~Standard care: Care as usual for participants starting a new ART regimen; this may vary by study site."
402219|NCT00988429|B4|Baseline|Total|Total of all reporting groups
402220|NCT00988429|B3|Baseline|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
402221|NCT00988429|B2|Baseline|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
402222|NCT00988429|B1|Baseline|Placebo|Matching placebo tablets QD orally
402223|NCT00988429|P3|Participant Flow|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
402224|NCT00988429|P2|Participant Flow|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
402225|NCT00988429|P1|Participant Flow|Placebo|Matching placebo tablets QD orally
402226|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
402227|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
402228|NCT00988429|O1|Outcome|Placebo|Matching placebo tablets QD orally
402229|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
402230|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
402231|NCT00988429|O1|Outcome|Placebo (ITT Population)|Matching placebo tablets QD orally
402232|NCT00988429|E3|Reported Event|ESL 1200 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
402233|NCT00988429|E2|Reported Event|ESL 800 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
402234|NCT00988429|E1|Reported Event|Placebo (Safety Population)|Matching placebo tablets QD orally
402235|NCT00988351|B3|Baseline|Total|Total of all reporting groups
402236|NCT00988351|B2|Baseline|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402265|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402237|NCT00988351|B1|Baseline|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402238|NCT00988351|P2|Participant Flow|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402239|NCT00988351|P1|Participant Flow|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402240|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402241|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402242|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402243|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402244|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402245|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402246|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402247|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402248|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402249|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402250|NCT00988351|E2|Reported Event|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
402251|NCT00988351|E1|Reported Event|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
402252|NCT00988325|B4|Baseline|Total|Total of all reporting groups
402253|NCT00988325|B3|Baseline|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402254|NCT00988325|B2|Baseline|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402255|NCT00988325|B1|Baseline|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
402256|NCT00988325|P3|Participant Flow|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days.
402257|NCT00988325|P2|Participant Flow|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402258|NCT00988325|P1|Participant Flow|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
402259|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402260|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402261|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402262|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402263|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402264|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
419166|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
402267|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
402268|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402269|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402270|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402271|NCT00988325|O3|Outcome|Type B|Genotype B was present in 12, 2, and 2 participants of age groups <365 days, 31 to 90 days, and <=30 days, respectively.
402272|NCT00988325|O2|Outcome|Type A H3|Genotype Type A H3 was present in 4 participants and 6 participants of age groups 91 to <365 days and 31 to 90 days, respectively
402273|NCT00988325|O1|Outcome|Type A (H1N1)pdm09|Genotype A (H1N1)pdm09 was present in 21 participants of age group 91 to <365 days, 9 participants of age group 31 to 90 days, and 2 participants of age group <=30 days
402274|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402275|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402276|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
402277|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402278|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402279|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402280|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402281|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402282|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402283|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402284|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402285|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402286|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402287|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402288|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402289|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402290|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402291|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
402292|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402293|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402294|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
402295|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402296|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402297|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402298|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402299|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402300|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
402301|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402302|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402303|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402304|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402305|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402306|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
402307|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402308|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
402309|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
402423|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402310|NCT00988325|E3|Reported Event|Oseltamivir 2 mg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
402311|NCT00988325|E2|Reported Event|Oseltamivir 2.5 mg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/ twice a day for 5 days
402312|NCT00988325|E1|Reported Event|Oseltamivir 3 mg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
402313|NCT00988247|B3|Baseline|Total|Total of all reporting groups
402314|NCT00988247|B2|Baseline|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402315|NCT00988247|B1|Baseline|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402316|NCT00988247|P2|Participant Flow|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402317|NCT00988247|P1|Participant Flow|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402318|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402319|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402320|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402321|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402322|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402323|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402324|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402325|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402326|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402327|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402328|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402329|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402330|NCT00988247|E2|Reported Event|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
402331|NCT00988247|E1|Reported Event|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
402332|NCT00988221|B4|Baseline|Total|Total of all reporting groups
402333|NCT00988221|B3|Baseline|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402334|NCT00988221|B2|Baseline|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402335|NCT00988221|B1|Baseline|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402336|NCT00988221|P4|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402337|NCT00988221|P3|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402338|NCT00988221|P2|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402339|NCT00988221|P1|Participant Flow|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402340|NCT00988221|O3|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402341|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402342|NCT00988221|O1|Outcome|Placebo to Tocilizumab|Patients received placebo to tocilizumab intravenously every 4 weeks.
402343|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
419167|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
402344|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402345|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402346|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402347|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402348|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402349|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402350|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402351|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402352|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402353|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402354|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402355|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402356|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402357|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402358|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402359|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402360|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402361|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402362|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402363|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402364|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402365|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402366|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402367|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402368|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402369|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402370|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402371|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402372|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402373|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402374|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402375|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402376|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402377|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402378|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402379|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402380|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402381|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402382|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
419168|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
402384|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402385|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402386|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402387|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402388|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402389|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402390|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402391|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402392|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402393|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402394|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402395|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402396|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402397|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402398|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402399|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402400|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402401|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402402|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402403|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402404|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402405|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402406|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402407|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402408|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402409|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402410|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402411|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402412|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402413|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402414|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402415|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402416|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402417|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402418|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402419|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402420|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402421|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402422|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
419169|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
402424|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402425|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402426|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402427|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402428|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402429|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402430|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402431|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402432|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402433|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402434|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402435|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402436|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402437|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402438|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402439|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402440|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402441|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402442|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402443|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402444|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402445|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402446|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402447|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402448|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402449|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402450|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402451|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402452|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402453|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402454|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402455|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402456|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402457|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402458|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402459|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402460|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402461|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402462|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402463|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402464|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402465|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402466|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402467|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402468|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402469|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402470|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402471|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402856|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
402472|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402473|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402474|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402475|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402476|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402477|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402478|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402479|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402480|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402481|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402482|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402483|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402484|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402485|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402486|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402487|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402488|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402489|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402490|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402491|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402492|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402493|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402494|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402495|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402496|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402497|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402498|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402499|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402500|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402501|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402502|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402503|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
402504|NCT00988221|E5|Reported Event|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
402505|NCT00988221|E4|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402506|NCT00988221|E3|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
402507|NCT00988221|E2|Reported Event|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
402508|NCT00988221|E1|Reported Event|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
402509|NCT00988208|B3|Baseline|Total|Total of all reporting groups
402510|NCT00988208|B2|Baseline|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402511|NCT00988208|B1|Baseline|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402512|NCT00988208|P2|Participant Flow|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402513|NCT00988208|P1|Participant Flow|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402546|NCT00988143|B3|Baseline|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402514|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402515|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402516|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402517|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402518|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402519|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402520|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402521|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402522|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402523|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402524|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402525|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402526|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402527|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402528|NCT00988208|E2|Reported Event|Docetaxel/ Prednisone/and Placebo (DP)|Participants received Docetaxel 75 mg/m^2 by intravenous (IV) administration over 30-60 minutes on Day 1, Prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402529|NCT00988208|E1|Reported Event|Docetaxel/Prednisone/Lenalidomide (DPL)|Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
402530|NCT00988169|B1|Baseline|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
402531|NCT00988169|P1|Participant Flow|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
402532|NCT00988169|O1|Outcome|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
402533|NCT00988169|E1|Reported Event|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
402534|NCT00988156|B3|Baseline|Total|Total of all reporting groups
402535|NCT00988156|B2|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
402536|NCT00988156|B1|Baseline|Placebo|Placebo matching placebo
402537|NCT00988156|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
402538|NCT00988156|P1|Participant Flow|Placebo|Placebo matching placebo
402539|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
402540|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
402541|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
402542|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
402543|NCT00988156|E2|Reported Event|Esl (Safety Set Part I)|
402544|NCT00988156|E1|Reported Event|Placebo (Safety Set Part I)|
402545|NCT00988143|B4|Baseline|Total|Total of all reporting groups
402589|NCT00988091|B3|Baseline|Total|Total of all reporting groups
402547|NCT00988143|B2|Baseline|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402548|NCT00988143|B1|Baseline|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402549|NCT00988143|P3|Participant Flow|Study Group 3 (QIV)|Participants received the Quadrivalent Influenza Vaccine
402550|NCT00988143|P2|Participant Flow|Study Group 2 (2008-2009 TIV)|Participants received the 2008-2009 Trivalent Influenza Vaccine
402551|NCT00988143|P1|Participant Flow|Study Group 1 (2009-2010 TIV)|Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives)
402552|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402553|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402554|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402555|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402556|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402557|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402558|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402559|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402560|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402561|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402562|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402563|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402564|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402565|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402566|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402567|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402568|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402569|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402570|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402571|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402572|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402573|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402574|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402575|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402576|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402577|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402578|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402579|NCT00988143|E3|Reported Event|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
402580|NCT00988143|E2|Reported Event|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
402581|NCT00988143|E1|Reported Event|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
402582|NCT00988117|B1|Baseline|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
402583|NCT00988117|P1|Participant Flow|Rivastigmine|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
402584|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
402585|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
402586|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
402587|NCT00988117|E2|Reported Event|Rivastigmine 9.5 mg/24 Hours|The Exelon patch was administered at a dosage of 9.5 mg/24 hours from week 4 to 12.
402588|NCT00988117|E1|Reported Event|Rivastigmine 4.6mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4.
402590|NCT00988091|B2|Baseline|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402591|NCT00988091|B1|Baseline|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402592|NCT00988091|P2|Participant Flow|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402593|NCT00988091|P1|Participant Flow|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402594|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402595|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402596|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402597|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402598|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402599|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402600|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402601|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402602|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402603|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402604|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402605|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402669|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402606|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
402607|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
402608|NCT00988091|E3|Reported Event|IA-BioHA: Open-label Period|Participants had the option of continuing into the open-label period in which their target knee received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) and they were followed for an additional 26 weeks.
402609|NCT00988091|E2|Reported Event|IA-BioHA: Double-blind Period|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
402610|NCT00988091|E1|Reported Event|IA-SA: Double-blind Period|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
402611|NCT00988065|B4|Baseline|Total|Total of all reporting groups
402612|NCT00988065|B3|Baseline|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402613|NCT00988065|B2|Baseline|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402614|NCT00988065|B1|Baseline|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402615|NCT00988065|P3|Participant Flow|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402616|NCT00988065|P2|Participant Flow|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402617|NCT00988065|P1|Participant Flow|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402618|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402619|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402620|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402621|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402622|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402623|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402624|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402625|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402626|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402627|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402628|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402629|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402630|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402631|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402632|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402633|NCT00988065|E3|Reported Event|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402634|NCT00988065|E2|Reported Event|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402635|NCT00988065|E1|Reported Event|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
402636|NCT00987948|B1|Baseline|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
402637|NCT00987948|P1|Participant Flow|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
402638|NCT00987948|O1|Outcome|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
402639|NCT00987948|O1|Outcome|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
402640|NCT00987948|E1|Reported Event|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
402641|NCT00987935|B10|Baseline|Total|Total of all reporting groups
402670|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
402642|NCT00987935|B9|Baseline|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402643|NCT00987935|B8|Baseline|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402644|NCT00987935|B7|Baseline|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402645|NCT00987935|B6|Baseline|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402646|NCT00987935|B5|Baseline|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402647|NCT00987935|B4|Baseline|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402648|NCT00987935|B3|Baseline|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402649|NCT00987935|B2|Baseline|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402650|NCT00987935|B1|Baseline|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
402651|NCT00987935|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402652|NCT00987935|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402653|NCT00987935|P7|Participant Flow|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402654|NCT00987935|P6|Participant Flow|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402655|NCT00987935|P5|Participant Flow|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402656|NCT00987935|P4|Participant Flow|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402657|NCT00987935|P3|Participant Flow|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402658|NCT00987935|P2|Participant Flow|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402659|NCT00987935|P1|Participant Flow|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
402660|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
402661|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402662|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
402663|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402664|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
402665|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402666|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
402667|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402668|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
402719|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease is now defined as total cumulative BILAG score >/= 17
402671|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402672|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
402673|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402674|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402675|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402676|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402677|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402678|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402679|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402680|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402681|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402682|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402683|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402684|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402685|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402686|NCT00987935|O1|Outcome|Phase I Group 1, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
402687|NCT00987935|O9|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402688|NCT00987935|O8|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402689|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402690|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402691|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402692|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402693|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402694|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
402695|NCT00987935|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
402696|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402697|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402698|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402699|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
402700|NCT00987935|O2|Outcome|Group 2|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402701|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
402702|NCT00987935|E9|Reported Event|Phase II Sorafenib, 400 mg Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid) during Phase II
402703|NCT00987935|E8|Reported Event|Phase II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) during Phase II
402704|NCT00987935|E7|Reported Event|Phase I Group II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
402705|NCT00987935|E6|Reported Event|Phase I Group II Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
402706|NCT00987935|E5|Reported Event|Phase I Group II Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
402707|NCT00987935|E4|Reported Event|Phase I Group II Nintedanib, 50 mg Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
402708|NCT00987935|E3|Reported Event|Phase I Group I Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
402709|NCT00987935|E2|Reported Event|Phase I Group I Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
402710|NCT00987935|E1|Reported Event|Phase I Group I Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
402711|NCT00987831|B4|Baseline|Total|Total of all reporting groups
402712|NCT00987831|B3|Baseline|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
402713|NCT00987831|B2|Baseline|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
402714|NCT00987831|B1|Baseline|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppresion vs themselves serving as their own control flaring later....not on immune suppression.
402715|NCT00987831|P3|Participant Flow|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
402716|NCT00987831|P2|Participant Flow|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
402717|NCT00987831|P1|Participant Flow|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
402718|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease is now defined as BILAG < 17 in cumulative score
402848|NCT00986986|B3|Baseline|Total|Total of all reporting groups
402720|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease activity is defined as up to 3 BILAG B, no A, and SLEDAI </= 10.
402721|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease activity is defined as > 3 BILAG B, OR at least one BILAG A or SLEDAI > 10 OR Meets Definition for severe Flare on SELENA SLEDAI
402722|NCT00987831|E3|Reported Event|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
402723|NCT00987831|E2|Reported Event|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
402724|NCT00987831|E1|Reported Event|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
402725|NCT00987727|B3|Baseline|Total|Total of all reporting groups
402726|NCT00987727|B2|Baseline|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
402727|NCT00987727|B1|Baseline|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
402728|NCT00987727|P2|Participant Flow|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
402729|NCT00987727|P1|Participant Flow|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
402730|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
402731|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
402732|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
402733|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
402734|NCT00987727|E2|Reported Event|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
402735|NCT00987727|E1|Reported Event|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
402736|NCT00987623|B3|Baseline|Total|Total of all reporting groups
402737|NCT00987623|B2|Baseline|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402738|NCT00987623|B1|Baseline|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402739|NCT00987623|P2|Participant Flow|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402740|NCT00987623|P1|Participant Flow|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402741|NCT00987623|O2|Outcome|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402742|NCT00987623|O1|Outcome|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402743|NCT00987623|E2|Reported Event|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402744|NCT00987623|E1|Reported Event|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
402745|NCT00987558|B1|Baseline|Eslicarbazepine Acetate + Simvastatin|"Simvastatin 80 mg + eslicarbazepine acetate 800 mg~Simvastatin + ESL: Oral single-dose of simvastatin 80 mg on two occasions ─ once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days ─ separated by a washout period of 3 weeks or more."
402746|NCT00987558|P2|Participant Flow|ESL, Then Simvastatin|Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day Washout period - 3 weeks Simvastatin 80 mg - Oral single-dose administered alone
402747|NCT00987558|P1|Participant Flow|Simvastatin, Then ESL + Simvastatin|Simvastatin 80 mg - Oral single-dose administered alone Washout period - 3 weeks Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day
402748|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
402749|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
402750|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
402751|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
402752|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
402753|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
402754|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
402755|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
402756|NCT00987558|E3|Reported Event|Eslicarbazepine Acetate + Simvastatin|Simvastatin 80 mg + eslicarbazepine acetate 800 mg
402757|NCT00987558|E2|Reported Event|Eslicarbazepine Acetate|eslicarbazepine acetate 800 mg
402758|NCT00987558|E1|Reported Event|Simvastatin|Simvastatin 80 mg
402849|NCT00986986|B2|Baseline|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
402917|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402759|NCT00987467|B1|Baseline|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
402760|NCT00987467|P1|Participant Flow|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
402761|NCT00987467|O1|Outcome|Topical Steroid Resistant/Dependant AKC|Patients with topical steroid resistant or dependant AKC were used for this study.
402762|NCT00987467|O1|Outcome|Patients With Steroid Resistant/ Dependant AKC.|Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
402763|NCT00987467|E1|Reported Event|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
402764|NCT00987415|B3|Baseline|Total|Total of all reporting groups
402765|NCT00987415|B2|Baseline|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402766|NCT00987415|B1|Baseline|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402767|NCT00987415|P2|Participant Flow|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402768|NCT00987415|P1|Participant Flow|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402769|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402770|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402771|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402772|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402773|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402774|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402775|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402776|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402777|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402778|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402779|NCT00987415|E2|Reported Event|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402780|NCT00987415|E1|Reported Event|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
402781|NCT00987402|B3|Baseline|Total|Total of all reporting groups
402782|NCT00987402|B2|Baseline|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
402783|NCT00987402|B1|Baseline|Plain Soap and Water|Surgical hand preparation with plain soap and water
402784|NCT00987402|P2|Participant Flow|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
402785|NCT00987402|P1|Participant Flow|Plain Soap and Water|Surgical hand preparation with plain soap and water
402786|NCT00987402|O2|Outcome|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
402787|NCT00987402|O1|Outcome|Plain Soap and Water|Surgical hand preparation with plain soap and water
402788|NCT00987402|E2|Reported Event|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
402789|NCT00987402|E1|Reported Event|Plain Soap and Water|Surgical hand preparation with plain soap and water
402790|NCT00987337|B4|Baseline|Total|Total of all reporting groups
402850|NCT00986986|B1|Baseline|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
402851|NCT00986986|P2|Participant Flow|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
402857|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
402791|NCT00987337|B3|Baseline|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402792|NCT00987337|B2|Baseline|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402793|NCT00987337|B1|Baseline|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402794|NCT00987337|P3|Participant Flow|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402795|NCT00987337|P2|Participant Flow|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402796|NCT00987337|P1|Participant Flow|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 milligram (mg) tablet orally twice daily as blinded therapy along with pegylated interferon alpha-2a (pegIFN alpha-2a) 180 microgram (mcg) subcutaneously once weekly and ribavirin (RBV) 1000 milligram per day (mg/day) to participants weighing less than or equal to(<=) 75 kilogram (kg) or RBV 1200 mg/day to participants weighing greater than (>) 75 kg, orally in 2 divided doses up to Week 24. Participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) (HCV RNA <15 international units/milliliter [IU/mL]) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (greater than or equal to [>=] 15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75kg or RBV 1200 mg/day if participant weighed >75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402797|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402798|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402799|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402800|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402858|NCT00986986|O1|Outcome|Extended Release Niacin|HIV infected individuals receiving extended release niacin
402801|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402802|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402803|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402804|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402805|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402806|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402807|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402808|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402809|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402810|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402852|NCT00986986|P1|Participant Flow|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
402811|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402812|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402813|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402814|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402815|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402816|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402817|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402818|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402819|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402820|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402853|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
402821|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402822|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402823|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402824|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402825|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
402826|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
402827|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402828|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402829|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402830|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402831|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402854|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
402832|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402833|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402834|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402835|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402836|NCT00987337|E3|Reported Event|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
402837|NCT00987337|E2|Reported Event|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402838|NCT00987337|E1|Reported Event|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
402839|NCT00986999|B1|Baseline|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402840|NCT00986999|P1|Participant Flow|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402841|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402842|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402843|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402844|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402845|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402846|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402847|NCT00986999|E1|Reported Event|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
402859|NCT00986986|E2|Reported Event|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
402860|NCT00986986|E1|Reported Event|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
402861|NCT00986973|B1|Baseline|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day KUVAN for four months.
402862|NCT00986973|P1|Participant Flow|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
402863|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
402864|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
402865|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
402866|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
402867|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
402868|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
402869|NCT00986973|O1|Outcome|Sapropterin (KUVAN) Therapy|All subjects received KUVAN at a dose of 20/mg/kg/day for four months. Blood Phe levels were measured drawn before therapy and 4 months after starting therapy.
402870|NCT00986973|E1|Reported Event|Sapropterin (KUVAN) Therapy|All subjects will received KUVAN therapy 20 mg/kg/day for four months.
402871|NCT00986960|B3|Baseline|Total|Total of all reporting groups
402872|NCT00986960|B2|Baseline|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
402873|NCT00986960|B1|Baseline|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
402874|NCT00986960|P2|Participant Flow|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
402875|NCT00986960|P1|Participant Flow|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
402876|NCT00986960|O2|Outcome|Placebo|Saline: I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
402877|NCT00986960|O1|Outcome|Adrenocorticotropin Hormone|repository corticotropin injection: IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
402878|NCT00986960|E2|Reported Event|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
402879|NCT00986960|E1|Reported Event|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
402880|NCT00986947|B1|Baseline|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
402881|NCT00986947|P1|Participant Flow|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
402908|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402882|NCT00986947|O1|Outcome|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
402883|NCT00986947|O1|Outcome|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
402884|NCT00986947|E1|Reported Event|IvIg With Rituximab|"Intravenous immunoglobulin (IVIg) and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
402885|NCT00986921|B3|Baseline|Total|Total of all reporting groups
402886|NCT00986921|B2|Baseline|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402887|NCT00986921|B1|Baseline|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402888|NCT00986921|P2|Participant Flow|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique."
402889|NCT00986921|P1|Participant Flow|Standard Osmotic Dilator Insertion|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique."
402890|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402891|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402892|NCT00986921|O2|Outcome|Mifepristone|Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
402893|NCT00986921|O1|Outcome|Standard Osmotic Dilators|Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
402894|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used.~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402895|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402896|NCT00986921|E2|Reported Event|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402897|NCT00986921|E1|Reported Event|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
402898|NCT00986856|B3|Baseline|Total|Total of all reporting groups
402899|NCT00986856|B2|Baseline|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402900|NCT00986856|B1|Baseline|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402901|NCT00986856|P2|Participant Flow|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402902|NCT00986856|P1|Participant Flow|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402903|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402904|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402905|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402906|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402907|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402918|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402919|NCT00986856|E2|Reported Event|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
402920|NCT00986856|E1|Reported Event|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
402921|NCT00986674|B4|Baseline|Total|Total of all reporting groups
402922|NCT00986674|B3|Baseline|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402923|NCT00986674|B2|Baseline|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
402924|NCT00986674|B1|Baseline|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402925|NCT00986674|P3|Participant Flow|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402926|NCT00986674|P2|Participant Flow|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
402927|NCT00986674|P1|Participant Flow|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402928|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402929|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
402930|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402931|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402932|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
402933|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402934|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
419170|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
402935|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
402936|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
402937|NCT00986674|E3|Reported Event|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
402938|NCT00986674|E2|Reported Event|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
402939|NCT00986674|E1|Reported Event|Arm I (Carboplatin, Paclitaxel, Cetuximab)|Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
402940|NCT00986583|B3|Baseline|Total|Total of all reporting groups
402941|NCT00986583|B2|Baseline|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402942|NCT00986583|B1|Baseline|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
402943|NCT00986583|P2|Participant Flow|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402944|NCT00986583|P1|Participant Flow|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402945|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402946|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
402947|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402948|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
402949|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402950|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
402951|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402952|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
402953|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402954|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
402955|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402956|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
402957|NCT00986583|E2|Reported Event|Nonstatin Users|
402958|NCT00986583|E1|Reported Event|Statin Users|
402959|NCT00986570|B1|Baseline|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
402960|NCT00986570|P1|Participant Flow|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
403071|NCT00986349|E1|Reported Event|EndoBarrier Liner Device|All subjects who had a device attempted to be implanted. N = 23
402961|NCT00986570|O1|Outcome|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
402962|NCT00986570|E1|Reported Event|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
402963|NCT00986544|B3|Baseline|Total|Total of all reporting groups
402964|NCT00986544|B2|Baseline|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
402965|NCT00986544|B1|Baseline|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
402966|NCT00986544|P2|Participant Flow|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
402967|NCT00986544|P1|Participant Flow|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
402968|NCT00986544|O2|Outcome|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
402969|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
402970|NCT00986544|O2|Outcome|Drain|Drain positioned in the subhepatic space after laparoscopic cholecystectomy
402971|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
402972|NCT00986544|E2|Reported Event|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
402973|NCT00986544|E1|Reported Event|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
402974|NCT00986479|B3|Baseline|Total|Total of all reporting groups
402975|NCT00986479|B2|Baseline|Placebo/AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402976|NCT00986479|B1|Baseline|AZD6765 (150 mg)/ Placebo|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402977|NCT00986479|P2|Participant Flow|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402978|NCT00986479|P1|Participant Flow|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402979|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402980|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402981|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402982|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402983|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402984|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402985|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402986|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402987|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402988|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402989|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402990|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402991|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402992|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402993|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402994|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402995|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402996|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402997|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
402998|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
402999|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
403000|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
403001|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
403002|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
403003|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
403004|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
403005|NCT00986479|E2|Reported Event|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
403006|NCT00986479|E1|Reported Event|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
403007|NCT00986453|B1|Baseline|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
403008|NCT00986453|P1|Participant Flow|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
403009|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
403010|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
403011|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
403012|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
403013|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
403014|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
403015|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
403016|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
403017|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
403018|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
403019|NCT00986453|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
403020|NCT00986453|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
403021|NCT00986427|B3|Baseline|Total|Total of all reporting groups
403022|NCT00986427|B2|Baseline|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403023|NCT00986427|B1|Baseline|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403024|NCT00986427|P2|Participant Flow|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403025|NCT00986427|P1|Participant Flow|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403026|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403027|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403028|NCT00986427|O4|Outcome|Refresh® Dry Eye Untreated Nail|Refresh® Dry Eye Therapy Untreated Nail
403029|NCT00986427|O3|Outcome|Refresh® Dry Eye Treated Nail|Refresh® Dry Eye Therapy Treated Nail
403030|NCT00986427|O2|Outcome|Restasis® Arm Untreated Nail|Restasis® Untreated Nail
403031|NCT00986427|O1|Outcome|Restasis® Arm Treated Nail|Restasis® Treated Nail
403032|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403033|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403034|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403035|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403036|NCT00986427|E2|Reported Event|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403037|NCT00986427|E1|Reported Event|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
403038|NCT00986401|B3|Baseline|Total|Total of all reporting groups
403039|NCT00986401|B2|Baseline|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
403040|NCT00986401|B1|Baseline|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
403041|NCT00986401|P2|Participant Flow|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
403042|NCT00986401|P1|Participant Flow|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
403043|NCT00986401|O2|Outcome|Sanctura XR® + Glucophage®|Sanctura XR® + Glucophage®
403044|NCT00986401|O1|Outcome|Sanctura XR®|Sanctura XR®
403045|NCT00986401|O2|Outcome|Glucophage® + Sanctura XR®|Glucophage® + Sanctura XR®
403046|NCT00986401|O1|Outcome|Glucophage®|Glucophage®
403047|NCT00986401|E3|Reported Event|Sanctura XR® in Combination With Glucophage®|Sanctura XR® in combination with Glucophage®
403048|NCT00986401|E2|Reported Event|Sanctura XR®|Sanctura XR®
403049|NCT00986401|E1|Reported Event|Glucophage®|Glucophage®
403050|NCT00986362|B3|Baseline|Total|Total of all reporting groups
403051|NCT00986362|B2|Baseline|Placebo|Placebo : Placebo intravitreal injection
403052|NCT00986362|B1|Baseline|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
403053|NCT00986362|P2|Participant Flow|Placebo|Placebo : Placebo intravitreal injection
403054|NCT00986362|P1|Participant Flow|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
403055|NCT00986362|O2|Outcome|Placebo|Placebo : Placebo intravitreal injection
403056|NCT00986362|O1|Outcome|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
403057|NCT00986362|E2|Reported Event|Placebo|Placebo : Placebo intravitreal injection
403058|NCT00986362|E1|Reported Event|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
403059|NCT00986349|B1|Baseline|EndoBarrier Liner Device|EndoBarrier Liner: 52 week treatment of EndoBarrier Liner
403060|NCT00986349|P1|Participant Flow|EndoBarrier Liner Device|Enrolled Subjects
403061|NCT00986349|O1|Outcome|Diabetes|"Single Arm~EndoBarrier Liner: 52 week treatment of EnoBarrier Liner"
403062|NCT00986349|O1|Outcome|EndoBarrier Liner Device|52 week treatment of EndoBarrier Liner
403063|NCT00986349|O3|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects who completed 12-month implant duration
403064|NCT00986349|O2|Outcome|Decrease in Glucose-Lowering Meds|Subjects who completed 12-month implant duration
403065|NCT00986349|O1|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjecst who completed 12 month implant duration
403066|NCT00986349|O5|Outcome|EndoBarrier Liner Device % at 52 Weeks|HbA1c
403067|NCT00986349|O4|Outcome|EndoBarrier Liner Device % at 9 Months|HbA1c
403068|NCT00986349|O3|Outcome|EndoBarrier Liner Device % at 6 Months|HbA1c
403069|NCT00986349|O2|Outcome|EndoBarrier Liner Device at 3 Months|HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
403070|NCT00986349|O1|Outcome|EndoBarrier Liner Device at Baseline|HbA1c %
419171|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
403072|NCT00986258|B1|Baseline|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403073|NCT00986258|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403074|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
403075|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
403076|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
403077|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
403078|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
403079|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
403080|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
403081|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
403082|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
403083|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403084|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403085|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403086|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403087|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403126|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
404829|NCT00983918|O3|Outcome|Isoflurane|General Anesthesia with Isoflurane
403088|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403089|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403090|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403091|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403092|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403093|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403094|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403095|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403096|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403224|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403097|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403098|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403099|NCT00986258|E1|Reported Event|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
403100|NCT00986245|B1|Baseline|Entire Study Population|Includes groups randomized to receive once daily first and twice daily first.
403101|NCT00986245|P2|Participant Flow|Ropinirole PR-Twice Daily First, Then Once Daily|Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period)
403102|NCT00986245|P1|Participant Flow|Ropinirole PR-Once Daily First, Then Twice Daily|Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period)
403103|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403104|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403105|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403106|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403107|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403108|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403109|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403110|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403111|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403112|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403113|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403114|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403115|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403116|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403117|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403118|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403119|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403120|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403121|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403122|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403123|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403124|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403125|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
419172|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
403127|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
403128|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
403129|NCT00986245|O3|Outcome|No Preference|No preference group
403130|NCT00986245|O2|Outcome|Twice-daily|Twice-daily preferred group
403131|NCT00986245|O1|Outcome|Once-daily|Once-daily preferred group
403132|NCT00986245|E2|Reported Event|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403133|NCT00986245|E1|Reported Event|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
403134|NCT00986232|B5|Baseline|Total|Total of all reporting groups
403135|NCT00986232|B4|Baseline|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403136|NCT00986232|B3|Baseline|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403137|NCT00986232|B2|Baseline|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403138|NCT00986232|B1|Baseline|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403139|NCT00986232|P4|Participant Flow|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403140|NCT00986232|P3|Participant Flow|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403141|NCT00986232|P2|Participant Flow|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403142|NCT00986232|P1|Participant Flow|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403143|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403144|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403145|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403146|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403147|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403148|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403149|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403150|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403151|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403152|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403153|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403154|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403155|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403156|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403157|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403158|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403159|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403225|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403160|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403161|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403162|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403163|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403164|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403165|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403166|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403167|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403168|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403169|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403170|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403171|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403172|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403173|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403174|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403175|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403176|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403177|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403178|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403179|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403180|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403181|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403182|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403183|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403184|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403185|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403186|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403187|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403188|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403189|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403190|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403191|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403192|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403193|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403194|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403195|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403196|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403197|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403198|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403199|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403200|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403201|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403202|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403203|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403204|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403205|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403206|NCT00986232|E7|Reported Event|ProQuad (High Dose) After Injection 2|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403207|NCT00986232|E6|Reported Event|ProQuad (Middle Dose) After Injection 2|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403208|NCT00986232|E5|Reported Event|ProQuad (Low Dose) After Injection 2|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403209|NCT00986232|E4|Reported Event|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
403210|NCT00986232|E3|Reported Event|ProQuad (High Dose) After Injection 1|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403211|NCT00986232|E2|Reported Event|ProQuad (Middle Dose) After Injection 1|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403212|NCT00986232|E1|Reported Event|ProQuad (Low Dose) After Injection 1|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
403213|NCT00986180|B3|Baseline|Total|Total of all reporting groups
403214|NCT00986180|B2|Baseline|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403215|NCT00986180|B1|Baseline|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403216|NCT00986180|P2|Participant Flow|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403217|NCT00986180|P1|Participant Flow|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403218|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403219|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403220|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403221|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403222|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403223|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403226|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403227|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403228|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403229|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403230|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403231|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403232|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403233|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403234|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403235|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403236|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403237|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403238|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403239|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403240|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403241|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403242|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403243|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403244|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403245|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403246|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403247|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403248|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403249|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403250|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403251|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403252|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403253|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403254|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403255|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403256|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403257|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403258|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403259|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403260|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403261|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403262|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403263|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403264|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403265|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403266|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403267|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403268|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403269|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403270|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403271|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403272|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403273|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403274|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
404830|NCT00983918|O2|Outcome|Sevoflurane|General Anesthesia with Sevoflurane
403275|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403276|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403277|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403278|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403279|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403280|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403281|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403282|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403283|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403284|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403285|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403286|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403287|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403288|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403289|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403290|NCT00986180|E2|Reported Event|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
403291|NCT00986180|E1|Reported Event|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
403292|NCT00986154|B3|Baseline|Total|Total of all reporting groups
403293|NCT00986154|B2|Baseline|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
403294|NCT00986154|B1|Baseline|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
403295|NCT00986154|P2|Participant Flow|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
403296|NCT00986154|P1|Participant Flow|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
403297|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
403298|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
403299|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
403300|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
403301|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
403340|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403302|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
403303|NCT00986154|E2|Reported Event|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
403304|NCT00986154|E1|Reported Event|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
403305|NCT00986102|B5|Baseline|Total|Total of all reporting groups
403306|NCT00986102|B4|Baseline|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403307|NCT00986102|B3|Baseline|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403308|NCT00986102|B2|Baseline|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403309|NCT00986102|B1|Baseline|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403310|NCT00986102|P4|Participant Flow|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403311|NCT00986102|P3|Participant Flow|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403312|NCT00986102|P2|Participant Flow|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403313|NCT00986102|P1|Participant Flow|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403314|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403315|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403316|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403317|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403318|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403319|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403320|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403321|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403322|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403323|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403324|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403325|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403326|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403327|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403328|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403329|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403330|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403331|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403332|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403333|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403334|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403335|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403336|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403337|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403338|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403339|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403341|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403342|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403343|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403344|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403345|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403346|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403347|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403348|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403349|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403350|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403351|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403352|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403353|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403354|NCT00986102|E4|Reported Event|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
403355|NCT00986102|E3|Reported Event|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
403356|NCT00986102|E2|Reported Event|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403357|NCT00986102|E1|Reported Event|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
403358|NCT00985985|B5|Baseline|Total|Total of all reporting groups
403359|NCT00985985|B4|Baseline|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
403360|NCT00985985|B3|Baseline|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
403361|NCT00985985|B2|Baseline|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally.
403362|NCT00985985|B1|Baseline|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally.
403363|NCT00985985|P4|Participant Flow|Placebo Lozenge (High Dependence Smoke|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
403364|NCT00985985|P3|Participant Flow|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
403365|NCT00985985|P2|Participant Flow|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take atleast 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse
403366|NCT00985985|P1|Participant Flow|Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. During week 1 to week 6,participants were recommended to take at least 9 lozenges per day, but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
403367|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
403368|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
403369|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine, orally.
403370|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
403371|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
403372|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
403373|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
403374|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
403375|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
403376|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
403377|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
403378|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
403379|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine, orally.
403380|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
403381|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
403382|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
403383|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
403384|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
403385|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
403386|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
403387|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
403388|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
403389|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
403390|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
403391|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
403392|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
403393|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
403394|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
403395|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
403396|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
403397|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
403398|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
403399|NCT00985985|E4|Reported Event|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
403400|NCT00985985|E3|Reported Event|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally.
403401|NCT00985985|E2|Reported Event|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
403402|NCT00985985|E1|Reported Event|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally.
403403|NCT00985959|B4|Baseline|Total|Total of all reporting groups
403404|NCT00985959|B3|Baseline|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
403405|NCT00985959|B2|Baseline|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403406|NCT00985959|B1|Baseline|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403996|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
403407|NCT00985959|P3|Participant Flow|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
403408|NCT00985959|P2|Participant Flow|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403409|NCT00985959|P1|Participant Flow|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403410|NCT00985959|O1|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
403411|NCT00985959|O1|Outcome|Prednisolone|Prednisolone 60 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
403412|NCT00985959|O1|Outcome|Melphalan|Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
403413|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403414|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403415|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403416|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403417|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403418|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403419|NCT00985959|O5|Outcome|Total|Participants from both Phase I and Phase II
403420|NCT00985959|O4|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
403421|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403422|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403423|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403424|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403425|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403426|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403427|NCT00985959|E4|Reported Event|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
403428|NCT00985959|E3|Reported Event|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403429|NCT00985959|E2|Reported Event|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403430|NCT00985959|E1|Reported Event|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
403431|NCT00985946|B1|Baseline|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
403432|NCT00985946|P1|Participant Flow|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
403552|NCT00985751|E5|Reported Event|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403433|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
403434|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
403435|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
403436|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
403437|NCT00985946|O1|Outcome|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.
403438|NCT00985946|E1|Reported Event|Panobinostat|Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design. Fifteen patients were accrued, and 13 were evaluable for response. No responses were seen, but the stable disease rate was 100%. The median progression-free survival (PFS) was 9.9 months, and the median overall survival was 47.3 months. Fatigue (27%), thrombocytopenia (20%), diarrhea (13%), and nausea (13%) were the most common related grade 3 toxicities. There was one grade 4 thrombocytopenia (7%). These results did not meet the prespecified criteria to open the study to full accrual.
403439|NCT00985829|B1|Baseline|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
403440|NCT00985829|P1|Participant Flow|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
403441|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
403442|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
403443|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
403444|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
403445|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
403446|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
403447|NCT00985829|E1|Reported Event|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
403448|NCT00985790|B3|Baseline|Total|Total of all reporting groups
403449|NCT00985790|B2|Baseline|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403450|NCT00985790|B1|Baseline|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403451|NCT00985790|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403452|NCT00985790|P1|Participant Flow|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403453|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403454|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403455|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403456|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403457|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403458|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403459|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403460|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403461|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403462|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403463|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403464|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403465|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403593|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
419173|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
403466|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403467|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403468|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403469|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403470|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403471|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403472|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403473|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403474|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403475|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403476|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403477|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403478|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403479|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403480|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403481|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403482|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403483|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403484|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403485|NCT00985790|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
403486|NCT00985790|E1|Reported Event|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
403487|NCT00985751|B6|Baseline|Total|Total of all reporting groups
403488|NCT00985751|B5|Baseline|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403489|NCT00985751|B4|Baseline|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403490|NCT00985751|B3|Baseline|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403491|NCT00985751|B2|Baseline|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403492|NCT00985751|B1|Baseline|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403493|NCT00985751|P5|Participant Flow|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403494|NCT00985751|P4|Participant Flow|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403495|NCT00985751|P3|Participant Flow|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403496|NCT00985751|P2|Participant Flow|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403497|NCT00985751|P1|Participant Flow|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403498|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403499|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403594|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403595|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403500|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403501|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403502|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403503|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403504|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403505|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403506|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403507|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403508|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403509|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403510|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403511|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403512|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403513|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403514|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403515|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403516|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403517|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403518|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403519|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403520|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403521|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403522|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403523|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403524|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403525|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403526|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403527|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403528|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403529|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403530|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403531|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403532|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403533|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403902|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
403534|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403535|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403536|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403537|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403538|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403539|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403540|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403541|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403542|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403543|NCT00985751|O5|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403544|NCT00985751|O4|Outcome|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403545|NCT00985751|O3|Outcome|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403546|NCT00985751|O2|Outcome|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403547|NCT00985751|O1|Outcome|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403548|NCT00985751|O2|Outcome|GSK 2189242A Group|This group included subjects from GSK 2189242A-LD and GSK 2189242A-HD groups for whom pooled analysis was conducted.
403549|NCT00985751|O1|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403550|NCT00985751|O2|Outcome|Synflorix/GSK 2189242A Group|This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
403551|NCT00985751|O1|Outcome|Synflorix Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403903|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
403553|NCT00985751|E4|Reported Event|Synflorix/GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403554|NCT00985751|E3|Reported Event|Synflorix/GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403555|NCT00985751|E2|Reported Event|GSK 2189242A-HD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403556|NCT00985751|E1|Reported Event|GSK 2189242A-LD Group|Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
403557|NCT00985738|B3|Baseline|Total|Total of all reporting groups
403558|NCT00985738|B2|Baseline|Placebo|This group received a placebo followed by 3D mapping biopsy.
403559|NCT00985738|B1|Baseline|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
403560|NCT00985738|P2|Participant Flow|Placebo|This group received a placebo followed by 3D mapping biopsy.
403561|NCT00985738|P1|Participant Flow|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
403562|NCT00985738|O2|Outcome|Placebo|This group received a placebo followed by 3D mapping biopsy.
403563|NCT00985738|O1|Outcome|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
403564|NCT00985738|E2|Reported Event|Placebo|This group received a placebo followed by 3D mapping biopsy.
403565|NCT00985738|E1|Reported Event|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
403566|NCT00985725|B3|Baseline|Total|Total of all reporting groups
403567|NCT00985725|B2|Baseline|Placebo|Administered orally once-daily for 9 weeks.
403568|NCT00985725|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403569|NCT00985725|P2|Participant Flow|Placebo|Administered orally once-daily for 9 weeks.
403570|NCT00985725|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403571|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403572|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403573|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403574|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403575|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403576|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403577|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403578|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403579|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403580|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403581|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403582|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403583|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403584|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403585|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403586|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403587|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403588|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403589|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403590|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403591|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403592|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403596|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403597|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403598|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403599|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
403600|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403601|NCT00985725|E2|Reported Event|Placebo|Administered orally once-daily for 9 weeks.
403602|NCT00985725|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
403603|NCT00985712|B3|Baseline|Total|Total of all reporting groups
403604|NCT00985712|B2|Baseline|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403605|NCT00985712|B1|Baseline|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403606|NCT00985712|P2|Participant Flow|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403607|NCT00985712|P1|Participant Flow|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403608|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403609|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403610|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403611|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403612|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403613|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403614|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403615|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403616|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403617|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403618|NCT00985712|E2|Reported Event|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
403619|NCT00985712|E1|Reported Event|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
403620|NCT00985686|B5|Baseline|Total|Total of all reporting groups
403621|NCT00985686|B4|Baseline|Waitlist Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the waitlist arm.
403622|NCT00985686|B3|Baseline|Waitlist Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the waitlist arm.
403623|NCT00985686|B2|Baseline|Study Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the study arm.
403624|NCT00985686|B1|Baseline|Study Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the study arm.
403625|NCT00985686|P4|Participant Flow|Waitlist Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
403626|NCT00985686|P3|Participant Flow|Waitlist Arm, Younger Subgroup|"Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
403904|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
403997|NCT00985166|O2|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
404831|NCT00983918|O1|Outcome|Desflurane|General Anesthesia with Desflurane
403627|NCT00985686|P2|Participant Flow|Study Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
403628|NCT00985686|P1|Participant Flow|Study Arm, Younger Subgroup|"Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
403629|NCT00985686|O1|Outcome|Older Subgroup (19-24 Years of Age)|Subgroup of participants 19-24 years of age. Participants were randomized into the Study and Waitlist Arms.
403630|NCT00985686|O1|Outcome|Younger Subgroup (13-18 Years of Age)|Subgroup of participants 13-18 years of age. Participants were randomized into the Study and Waitlist Arms.
403631|NCT00985686|E4|Reported Event|Waitlist Arm, Older Subgroup|Participants 19-24 years of age randomized into the wait list group
403632|NCT00985686|E3|Reported Event|Waitlist Arm, Younger Subgroup|Participants 13-18 years of age randomized into the waitlist group
403633|NCT00985686|E2|Reported Event|Study Arm, Older Subgroup|Participants 19-24 years of age randomized into the study group
403634|NCT00985686|E1|Reported Event|Study Arm, Younger Subgroup|Participants 13-18 years of age randomized into the study group
403635|NCT00985673|B7|Baseline|Total|Total of all reporting groups
403636|NCT00985673|B6|Baseline|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403637|NCT00985673|B5|Baseline|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403638|NCT00985673|B4|Baseline|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403639|NCT00985673|B3|Baseline|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403640|NCT00985673|B2|Baseline|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403641|NCT00985673|B1|Baseline|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403642|NCT00985673|P6|Participant Flow|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403643|NCT00985673|P5|Participant Flow|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403644|NCT00985673|P4|Participant Flow|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403930|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403645|NCT00985673|P3|Participant Flow|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403646|NCT00985673|P2|Participant Flow|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403647|NCT00985673|P1|Participant Flow|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403648|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403649|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403650|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403651|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403652|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403653|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403654|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403655|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403656|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403657|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403658|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403659|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403998|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
403660|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403661|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403662|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403663|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403664|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403665|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403666|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403667|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403668|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403669|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403670|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403671|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403672|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403673|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403674|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403931|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403675|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403676|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403677|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403678|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403679|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403680|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403681|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403682|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403683|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403684|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403685|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403686|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403687|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403688|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403689|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403980|NCT00985192|E1|Reported Event|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403690|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403691|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403692|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403693|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403694|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403695|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403696|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403697|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403698|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403699|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403700|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403701|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403702|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403703|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403704|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403981|NCT00985166|B4|Baseline|Total|Total of all reporting groups
403982|NCT00985166|B3|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
403705|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403706|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403707|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403708|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403709|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403710|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403711|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403712|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403713|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403714|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403715|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403716|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403717|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403718|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403719|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403983|NCT00985166|B2|Baseline|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
419174|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
403720|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403721|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403722|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403723|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403724|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403725|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403726|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403727|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403728|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403729|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403730|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403731|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403732|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403733|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403734|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403984|NCT00985166|B1|Baseline|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
403735|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403736|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403737|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403738|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403739|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403740|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403741|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403742|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403743|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403744|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403745|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403746|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403747|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403748|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403749|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403985|NCT00985166|P3|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
404832|NCT00983918|E4|Reported Event|Propofol|General Anesthesia with Propofol
403750|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403751|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403752|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403753|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403754|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403755|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403756|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403757|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403758|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403759|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403760|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403761|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403762|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403763|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403764|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403986|NCT00985166|P2|Participant Flow|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
419175|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
403765|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403766|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403767|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403768|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403769|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403770|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403771|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403772|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403773|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403774|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403775|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403776|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403777|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403778|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403779|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403987|NCT00985166|P1|Participant Flow|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
403780|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403781|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403782|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403783|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403784|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403785|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403786|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403787|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403788|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403789|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403790|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403791|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403792|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403793|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403794|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403988|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
419176|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
403795|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403796|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403797|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403798|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403799|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403800|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403801|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403802|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403803|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403804|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403805|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403806|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403807|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403808|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403809|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403989|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
404833|NCT00983918|E3|Reported Event|Isoflurane|General Anesthesia with Isoflurane
403810|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403811|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403812|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403813|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403814|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403815|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403816|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403817|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403818|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403819|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403820|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403821|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403822|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403823|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403824|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403990|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
403825|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403826|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403827|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403828|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403829|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403830|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403831|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403832|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403833|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403834|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403835|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403836|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403837|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403838|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403839|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403991|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1
404834|NCT00983918|E2|Reported Event|Sevoflurane|General Anesthesia with Sevoflurane
403840|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403841|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403842|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403843|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403844|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403845|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403846|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403847|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403848|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403849|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403850|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403851|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403852|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403853|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403854|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403992|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
419177|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
403855|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403856|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403857|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403858|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403859|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403860|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403861|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403862|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403863|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403864|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403865|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403866|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403867|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403868|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403869|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403993|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
419178|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
403870|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403871|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403872|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403873|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403874|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403875|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403876|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403877|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403878|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403879|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403880|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403881|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403882|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403883|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403884|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403994|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
419179|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
403885|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403886|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403887|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403888|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403889|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403890|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403891|NCT00985673|E6|Reported Event|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403892|NCT00985673|E5|Reported Event|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403893|NCT00985673|E4|Reported Event|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403894|NCT00985673|E3|Reported Event|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403895|NCT00985673|E2|Reported Event|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403896|NCT00985673|E1|Reported Event|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
403897|NCT00985543|B1|Baseline|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
403898|NCT00985543|P1|Participant Flow|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
403899|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
403900|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
403901|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
403905|NCT00985543|E1|Reported Event|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
403906|NCT00985504|B3|Baseline|Total|Total of all reporting groups
403907|NCT00985504|B2|Baseline|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403908|NCT00985504|B1|Baseline|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403909|NCT00985504|P2|Participant Flow|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403910|NCT00985504|P1|Participant Flow|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403911|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403912|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403913|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403914|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403915|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403916|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403917|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403918|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403919|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403920|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403921|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403922|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403923|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403924|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403925|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403926|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403927|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403928|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403929|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403995|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
403932|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403933|NCT00985504|E2|Reported Event|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403934|NCT00985504|E1|Reported Event|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
403935|NCT00985491|B1|Baseline|EndoBarrier Liner Device|"46 subjects were enrolled. 3 subjects were implant failures. 43 Subjects received the device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
403936|NCT00985491|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
403937|NCT00985491|O1|Outcome|Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
403938|NCT00985491|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
403939|NCT00985491|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
403940|NCT00985439|B5|Baseline|Total|Total of all reporting groups
403941|NCT00985439|B4|Baseline|Placebo|
403942|NCT00985439|B3|Baseline|Celecoxib 400 mg|
403943|NCT00985439|B2|Baseline|Diclofenac Test (Upper Dose)|
403944|NCT00985439|B1|Baseline|Diclofenac Test (Lower Dose)|
403945|NCT00985439|P4|Participant Flow|Placebo|
403946|NCT00985439|P3|Participant Flow|Celecoxib 400 mg|
403947|NCT00985439|P2|Participant Flow|Diclofenac Test (Upper Dose)|
403948|NCT00985439|P1|Participant Flow|Diclofenac Test (Lower Dose)|
403949|NCT00985439|O4|Outcome|Placebo|
403950|NCT00985439|O3|Outcome|Celecoxib 400 mg|
403951|NCT00985439|O2|Outcome|Diclofenac Test (Upper Dose)|35-mg
403952|NCT00985439|O1|Outcome|Diclofenac Test (Lower Dose)|18-mg
403953|NCT00985439|E4|Reported Event|Placebo|
403954|NCT00985439|E3|Reported Event|Celecoxib 400 mg|
403955|NCT00985439|E2|Reported Event|Diclofenac Test (Upper Dose)|
403956|NCT00985439|E1|Reported Event|Diclofenac Test (Lower Dose)|
403957|NCT00985257|B1|Baseline|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
403958|NCT00985257|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
403959|NCT00985257|O1|Outcome|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
403960|NCT00985257|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
403961|NCT00985231|B3|Baseline|Total|Total of all reporting groups
403962|NCT00985231|B2|Baseline|SofLens59 Contact Lens|
403963|NCT00985231|B1|Baseline|PureVision Multi-Focal Contact Lenses|
403964|NCT00985231|P2|Participant Flow|SofLens59 Contact Lens|
403965|NCT00985231|P1|Participant Flow|PureVision Multi-Focal Contact Lenses|
403966|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
403967|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
403968|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
403969|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
403970|NCT00985231|E2|Reported Event|SofLens59 Contact Lens|
403971|NCT00985231|E1|Reported Event|PureVision Multi-Focal Contact Lenses|
403972|NCT00985192|B1|Baseline|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403973|NCT00985192|P1|Participant Flow|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403974|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403975|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403976|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403977|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403978|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
403979|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
404835|NCT00983918|E1|Reported Event|Desflurane|General Anesthesia with Desflurane
403999|NCT00985166|E3|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
404000|NCT00985166|E2|Reported Event|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
404001|NCT00985166|E1|Reported Event|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
404002|NCT00985153|B5|Baseline|Total|Total of all reporting groups
404003|NCT00985153|B4|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404004|NCT00985153|B3|Baseline|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404005|NCT00985153|B2|Baseline|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404006|NCT00985153|B1|Baseline|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404007|NCT00985153|P4|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404008|NCT00985153|P3|Participant Flow|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404009|NCT00985153|P2|Participant Flow|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404010|NCT00985153|P1|Participant Flow|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404011|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404012|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404013|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404014|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404015|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404016|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404017|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404018|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404019|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404020|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404021|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404022|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404023|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404024|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404025|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404026|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404027|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404028|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404029|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404030|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404031|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404032|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404033|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404034|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404035|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404036|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404037|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404038|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404039|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404040|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404041|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404042|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404043|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404044|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404045|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404046|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404047|NCT00985153|E4|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
404048|NCT00985153|E3|Reported Event|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
404049|NCT00985153|E2|Reported Event|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
404050|NCT00985153|E1|Reported Event|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
404051|NCT00985140|B1|Baseline|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy.
404052|NCT00985140|P1|Participant Flow|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
404053|NCT00985140|O1|Outcome|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
404054|NCT00985140|E1|Reported Event|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
404055|NCT00985114|B3|Baseline|Total|Total of all reporting groups
404056|NCT00985114|B2|Baseline|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
404057|NCT00985114|B1|Baseline|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
404058|NCT00985114|P2|Participant Flow|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
404059|NCT00985114|P1|Participant Flow|EndoBarrier Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
404060|NCT00985114|O2|Outcome|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
404061|NCT00985114|O1|Outcome|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
404062|NCT00985114|E2|Reported Event|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
404063|NCT00985114|E1|Reported Event|Device and Cross Over|"EndoBarrier~EndoBarrier: EndoBarrier implant"
404064|NCT00985088|B9|Baseline|Total|Total of all reporting groups
404065|NCT00985088|B8|Baseline|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404084|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404911|NCT00983749|B3|Baseline|Total|Total of all reporting groups
404066|NCT00985088|B7|Baseline|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404067|NCT00985088|B6|Baseline|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404068|NCT00985088|B5|Baseline|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404069|NCT00985088|B4|Baseline|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404070|NCT00985088|B3|Baseline|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404071|NCT00985088|B2|Baseline|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404072|NCT00985088|B1|Baseline|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404073|NCT00985088|P8|Participant Flow|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404074|NCT00985088|P7|Participant Flow|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404075|NCT00985088|P6|Participant Flow|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404076|NCT00985088|P5|Participant Flow|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404077|NCT00985088|P4|Participant Flow|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404078|NCT00985088|P3|Participant Flow|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404079|NCT00985088|P2|Participant Flow|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404080|NCT00985088|P1|Participant Flow|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404081|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404082|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404083|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404661|NCT00984165|P2|Participant Flow|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
404085|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404086|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404087|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404088|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404089|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404090|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404091|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404092|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404093|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404094|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404095|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404096|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404097|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404098|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404099|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404100|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404101|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404102|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404103|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404104|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404105|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404106|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404107|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404108|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404109|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404110|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404111|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404112|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404113|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404114|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404115|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404116|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404117|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404118|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404119|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404120|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404121|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404158|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404122|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404123|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404124|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404125|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404126|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404127|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404128|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404129|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404130|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404131|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404132|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404133|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404134|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404135|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404136|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404137|NCT00985088|O1|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404138|NCT00985088|O1|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404139|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404140|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404141|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404142|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404143|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404144|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404145|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404146|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404147|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404148|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404149|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404150|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404151|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404152|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404153|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404154|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404155|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404156|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404157|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404371|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
404159|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404160|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404161|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404162|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404163|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404164|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404165|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404166|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404167|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404168|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404169|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404170|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404171|NCT00985088|O2|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404172|NCT00985088|O1|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404173|NCT00985088|O2|Outcome|GSK2340273A F2 Group|Pooled group comprising the subjects from GSK2340273A F2_2D Group and GSK2340273A F2_1D Group.
404174|NCT00985088|O1|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404175|NCT00985088|O2|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404176|NCT00985088|O1|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_2D Group and GSK2340274A F2_1D Group.
404177|NCT00985088|O2|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404178|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404179|NCT00985088|O2|Outcome|GSK2340273A F2 Group|Pooled group comprising the subjects from GSK2340273A F2_1D Group and GSK2340273A F2_2D Group.
404180|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404181|NCT00985088|O2|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404182|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404183|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404184|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404185|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404186|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404187|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404188|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404189|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404190|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404191|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404192|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404193|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404194|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404195|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404196|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404197|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404198|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404199|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404200|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404372|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
404201|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404202|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404203|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404204|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404205|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404206|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404207|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404208|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404209|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404210|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404211|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404212|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404213|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404214|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404215|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404216|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404217|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404218|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404219|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404220|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404221|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404222|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404223|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404224|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404225|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404226|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404227|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404228|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404229|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404230|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404231|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404232|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404233|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404234|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404235|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404236|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404237|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404238|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404239|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404240|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404241|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404242|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404243|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404244|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404245|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404246|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404247|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404248|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404249|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404250|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404251|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404252|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404253|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404254|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404255|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404256|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404373|NCT00984815|E1|Reported Event|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
404257|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404258|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404259|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404260|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404261|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404262|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404263|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404264|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404265|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404266|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404267|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404268|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404269|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404270|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404271|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404272|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404273|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404274|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404275|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404276|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404277|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404278|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404279|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404280|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404281|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404282|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404283|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404284|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404285|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404286|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404287|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404288|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404289|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404290|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404291|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404292|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404293|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404294|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404295|NCT00985088|O8|Outcome|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404296|NCT00985088|O7|Outcome|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404297|NCT00985088|O6|Outcome|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404298|NCT00985088|O5|Outcome|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404299|NCT00985088|O4|Outcome|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404300|NCT00985088|O3|Outcome|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404301|NCT00985088|O2|Outcome|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404302|NCT00985088|O1|Outcome|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404303|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404304|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404305|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404306|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404307|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404308|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404309|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404310|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404311|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404312|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404313|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404314|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404315|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404316|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404317|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404318|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404319|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404320|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404321|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404322|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404323|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404324|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404325|NCT00985088|O2|Outcome|GSK2340274A F2 Group|Pooled group comprising the subjects from GSK2340274A F2_1D Group and GSK2340274A F2_2D Group.
404326|NCT00985088|O1|Outcome|GSK2340274A F1 Group|Pooled group comprising the subjects from GSK2340274A F1_2D Group and GSK2340274A F1_1D Group.
404327|NCT00985088|E8|Reported Event|GSK2340273A F3_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404374|NCT00984698|B3|Baseline|Total|Total of all reporting groups
404328|NCT00985088|E7|Reported Event|GSK2340273A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.
404329|NCT00985088|E6|Reported Event|GSK2340273A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404330|NCT00985088|E5|Reported Event|GSK2340273A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administrated intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404331|NCT00985088|E4|Reported Event|GSK2340274A F1_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404332|NCT00985088|E3|Reported Event|GSK2340274A F2_1D Group|Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404333|NCT00985088|E2|Reported Event|GSK2340274A F2_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404334|NCT00985088|E1|Reported Event|GSK2340274A F1_2D Group|Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.
404335|NCT00985010|B3|Baseline|Total|Total of all reporting groups
404336|NCT00985010|B2|Baseline|Males|Brain death
404337|NCT00985010|B1|Baseline|Females|Brain death
404338|NCT00985010|P2|Participant Flow|Males|Brain death
404339|NCT00985010|P1|Participant Flow|Females|Brain death
404340|NCT00985010|O2|Outcome|Males|Brain death
404341|NCT00985010|O1|Outcome|Females|Brain death
404342|NCT00985010|O2|Outcome|Males|Brain death
404343|NCT00985010|O1|Outcome|Females|Brain death
404344|NCT00985010|E2|Reported Event|Males|Brain death
404345|NCT00985010|E1|Reported Event|Females|Brain death
404346|NCT00984867|B3|Baseline|Total|Total of all reporting groups
404347|NCT00984867|B2|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
404348|NCT00984867|B1|Baseline|Placebo|Placebo plus sitagliptin alone or in combination with metformin
404349|NCT00984867|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
404350|NCT00984867|P1|Participant Flow|Placebo|Placebo plus sitagliptin alone or in combination with metformin
404351|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
404352|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
404353|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
404354|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
404355|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
404356|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
404357|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
404358|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
404359|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
404360|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
404361|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
404362|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
404363|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
404364|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin
404365|NCT00984867|E2|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
404366|NCT00984867|E1|Reported Event|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.
404367|NCT00984815|B1|Baseline|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
404368|NCT00984815|P1|Participant Flow|HZT-501|Open-label treatment with HZT-501(ibuprofen 800 mg/famotidine 26.6 mg) tablets. All doses of study drug will be self-administered orally 3 times daily (TID), for up to 54 weeks.
404369|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
404370|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
404375|NCT00984698|B2|Baseline|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
404376|NCT00984698|B1|Baseline|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
404377|NCT00984698|P2|Participant Flow|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
404378|NCT00984698|P1|Participant Flow|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
404379|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
404380|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
404381|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
404382|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
404383|NCT00984698|E2|Reported Event|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
404384|NCT00984698|E1|Reported Event|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
404385|NCT00984659|B5|Baseline|Total|Total of all reporting groups
404386|NCT00984659|B4|Baseline|Albuterol and/or Ipratropium: Run-in Failure|Participants who entered the 2-week Run-in Period, during which they were permitted to use albuterol and/or ipratropium as rescue medication, but then failed to be randomized, or were randomized but did not receive a dose of study medication
404387|NCT00984659|B3|Baseline|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID
404388|NCT00984659|B2|Baseline|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
404389|NCT00984659|B1|Baseline|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
404390|NCT00984659|P4|Participant Flow|FSC 250/50 mcg: Double-blind Treatment Period|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
404391|NCT00984659|P3|Participant Flow|SAL 50 mcg: Double-blind Treatment Period|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
404392|NCT00984659|P2|Participant Flow|Placebo: Double-blind Treatment Period|Matching placebo via DISKUS, administered as one inhalation twice daily (BID) during the 6-week Double-blind Treatment Period
404393|NCT00984659|P1|Participant Flow|Albuterol and/or Ipratropium: Run-in Period|Participants were permitted to use albuterol and/or ipratropium as rescue medication during the 2-week Run-in Period
404394|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404395|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404396|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404616|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
404397|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404398|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404399|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404400|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404401|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404402|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404403|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404404|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404405|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
404406|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404407|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404408|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404409|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404410|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404411|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404412|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404413|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
404414|NCT00984659|E3|Reported Event|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
404415|NCT00984659|E2|Reported Event|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
404416|NCT00984659|E1|Reported Event|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
404417|NCT00984620|B3|Baseline|Total|Total of all reporting groups
404418|NCT00984620|B2|Baseline|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404419|NCT00984620|B1|Baseline|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404420|NCT00984620|P2|Participant Flow|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404421|NCT00984620|P1|Participant Flow|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404422|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404617|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
404423|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404424|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404425|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404426|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404427|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404428|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404429|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404430|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404431|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404432|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404433|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404434|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404435|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404479|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
404618|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
404436|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404437|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404438|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404439|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404440|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404441|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404442|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404443|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404444|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404445|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404446|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404447|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404448|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404480|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
419180|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
404449|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404450|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404451|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404452|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404453|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
404454|NCT00984620|E2|Reported Event|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
404455|NCT00984620|E1|Reported Event|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.
404456|NCT00984594|B3|Baseline|Total|Total of all reporting groups
404457|NCT00984594|B2|Baseline|Primary|CR Plug will be placed in the site of the primary injury
404458|NCT00984594|B1|Baseline|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
404459|NCT00984594|P2|Participant Flow|Primary|CR Plug will be placed in the site of the primary injury.
404460|NCT00984594|P1|Participant Flow|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
404461|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
404462|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
404463|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
404464|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
404465|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
404466|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
404467|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
404468|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
404469|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury
404470|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
404471|NCT00984594|E2|Reported Event|Primary|Autograft will be placed in primary defect site.
404472|NCT00984594|E1|Reported Event|Backfill|CR-Plug will be placed in harvest site.
404473|NCT00984568|B3|Baseline|Total|Total of all reporting groups
404474|NCT00984568|B2|Baseline|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
404475|NCT00984568|B1|Baseline|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
404476|NCT00984568|P2|Participant Flow|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
404477|NCT00984568|P1|Participant Flow|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
404478|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
404481|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
404482|NCT00984568|E2|Reported Event|Step-Up|"Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2~g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter."
404483|NCT00984568|E1|Reported Event|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
404484|NCT00984542|B1|Baseline|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404485|NCT00984542|P1|Participant Flow|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404486|NCT00984542|O1|Outcome|Bendatmustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404487|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404488|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404489|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404490|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404491|NCT00984542|E1|Reported Event|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
404492|NCT00984490|B1|Baseline|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
404493|NCT00984490|P1|Participant Flow|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
404494|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery)
404495|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg orally (PO) twice a day for 7-21 days, discontinued 24-36 hrs prior to surgery
404496|NCT00984490|E1|Reported Event|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
404497|NCT00984334|B6|Baseline|Total|Total of all reporting groups
404498|NCT00984334|B5|Baseline|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
404499|NCT00984334|B4|Baseline|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
404500|NCT00984334|B3|Baseline|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
404501|NCT00984334|B2|Baseline|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
404502|NCT00984334|B1|Baseline|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
404503|NCT00984334|P5|Participant Flow|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
404504|NCT00984334|P4|Participant Flow|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
404505|NCT00984334|P3|Participant Flow|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
404506|NCT00984334|P2|Participant Flow|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
404507|NCT00984334|P1|Participant Flow|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
404508|NCT00984334|O5|Outcome|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
404509|NCT00984334|O4|Outcome|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
404510|NCT00984334|O3|Outcome|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
404511|NCT00984334|O2|Outcome|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
404512|NCT00984334|O1|Outcome|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
404513|NCT00984334|E5|Reported Event|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
404514|NCT00984334|E4|Reported Event|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
404515|NCT00984334|E3|Reported Event|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
404516|NCT00984334|E2|Reported Event|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
404517|NCT00984334|E1|Reported Event|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
404518|NCT00984308|B3|Baseline|Total|Total of all reporting groups
404519|NCT00984308|B2|Baseline|Control|
404520|NCT00984308|B1|Baseline|Intervention|
404521|NCT00984308|P2|Participant Flow|Control|The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
404522|NCT00984308|P1|Participant Flow|Intervention|The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
404532|NCT00984295|B3|Baseline|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404533|NCT00984295|B2|Baseline|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404534|NCT00984295|B1|Baseline|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404535|NCT00984295|P3|Participant Flow|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404536|NCT00984295|P2|Participant Flow|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404537|NCT00984295|P1|Participant Flow|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404538|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404539|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404540|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404541|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404542|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404543|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404544|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404545|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404546|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404547|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404548|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404549|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404550|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404619|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
404551|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404552|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404553|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404554|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404555|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404556|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404557|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404558|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404559|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404560|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404561|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404562|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404563|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404564|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404565|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404566|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404567|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404568|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404569|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404570|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404571|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404572|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404573|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404574|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404575|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404576|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404577|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404578|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404579|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404580|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404581|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404582|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404583|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404584|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404585|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404586|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404587|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404588|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404589|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404620|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
419181|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
404590|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404591|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404592|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404593|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404594|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404595|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404596|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404597|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404598|NCT00984295|E3|Reported Event|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404599|NCT00984295|E2|Reported Event|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
404600|NCT00984295|E1|Reported Event|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
404601|NCT00984282|B3|Baseline|Total|Total of all reporting groups
404602|NCT00984282|B2|Baseline|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
404603|NCT00984282|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
404604|NCT00984282|P2|Participant Flow|DB Placebo First, Then Option of OL Sorafenib Treatment|Double-blind period: participants received matching placebo tablets orally twice daily, 28 days comprised a cycle. Open-label (OL) period: participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle.
404605|NCT00984282|P1|Participant Flow|DB Sorafenib First, Then Option of OL Sorafenib Treatment|Double-blind period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Open-label (OL) period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
404606|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
404607|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
404608|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
404609|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
404610|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
404611|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
404612|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
404613|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
404614|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
404615|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
405443|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
404621|NCT00984282|E4|Reported Event|Placebo, Open Label Only (Switch to Sorafenib)|Reporting Group 3: Participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of open label period to the data cutoff on 31 Aug 20
404622|NCT00984282|E3|Reported Event|Sorafenib, Open Label Only (Sorafenib Continued)|Reporting Group 3: Participants on sorafenib who continued OL sorafenib treat., received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug
404623|NCT00984282|E2|Reported Event|Placebo (Double Blind Only)|Reporting Group 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period.
404624|NCT00984282|E1|Reported Event|Sorafenib (Double Blind Only)|Reporting Group 1: Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double blind period
404625|NCT00984256|B3|Baseline|Total|Total of all reporting groups
404626|NCT00984256|B2|Baseline|Control|The six (6) Control volunteers were enrolled in a open label arm and received no treatment prior to malaria challenge.
404627|NCT00984256|B1|Baseline|Malarone|"Thirty (30) subjects were placed in the Malarone (treatment) Arm. The thirty subjects were then randomized into 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge. The groups received treatment as follows:~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
404628|NCT00984256|P2|Participant Flow|Malarone Treatment|"Within the Malarone Arm, thirty volunteers were randomized into the below 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
404629|NCT00984256|P1|Participant Flow|Control|The six volunteers in control cohort were enrolled as infectivity controls and did not undergo randomization or receive any study drug.
404630|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
404631|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
404632|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
404633|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
404634|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
404635|NCT00984256|O5|Outcome|Prophylaxis Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
404636|NCT00984256|O4|Outcome|Prophylaxis Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
404637|NCT00984256|O3|Outcome|Prophylaxis Group 3|(Group 3)Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
404638|NCT00984256|O2|Outcome|Prophylaxis Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
404639|NCT00984256|O1|Outcome|Prophylaxis Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
404640|NCT00984256|O6|Outcome|Control|Six volunteers for the control cohort were enrolled as an infectivity control and did not undergo drug dosing.
404641|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
404642|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
404643|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
404644|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
404645|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
404646|NCT00984256|E2|Reported Event|Control|no malarone prophylaxis received
404647|NCT00984256|E1|Reported Event|Drug|"Partially randomized, double-blind, placebo-controlled trial using a human Plasmodium falciparum challenge to evaluate malaria chemoprophylaxis of Malarone in 36 healthy adults. Subjects were enrolled in 1 of 2 cohorts based on subject preference. Thirty subjects were placed in the prophylaxis cohort (Cohort 1) and 6 subjects were placed in the control cohort (Cohort 2)~5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
404648|NCT00984204|B1|Baseline|Treatment Arm|
404649|NCT00984204|P1|Participant Flow|Treatment Arm|
404650|NCT00984204|O1|Outcome|Treatment Arm|
404651|NCT00984204|O1|Outcome|Treatment Arm|
404652|NCT00984204|O1|Outcome|Treatment Arm|
404653|NCT00984204|E1|Reported Event|Treatment Arm|
404654|NCT00984165|B5|Baseline|Total|Total of all reporting groups
404655|NCT00984165|B4|Baseline|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
404656|NCT00984165|B3|Baseline|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
404657|NCT00984165|B2|Baseline|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
404658|NCT00984165|B1|Baseline|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
404659|NCT00984165|P4|Participant Flow|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
404660|NCT00984165|P3|Participant Flow|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
404662|NCT00984165|P1|Participant Flow|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
404663|NCT00984165|O4|Outcome|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
404664|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
404665|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
404666|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
404667|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion-Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
404668|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
404669|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
404670|NCT00984165|E4|Reported Event|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
404671|NCT00984165|E3|Reported Event|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
404672|NCT00984165|E2|Reported Event|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
404673|NCT00984165|E1|Reported Event|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
404674|NCT00984139|B1|Baseline|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404675|NCT00984139|P1|Participant Flow|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404676|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404677|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404678|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404679|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404680|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404681|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404682|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404683|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404684|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404685|NCT00984139|E1|Reported Event|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
404686|NCT00984126|B5|Baseline|Total|Total of all reporting groups
404687|NCT00984126|B4|Baseline|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404738|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
404739|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
404740|NCT00984022|E2|Reported Event|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
404741|NCT00984022|E1|Reported Event|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
404688|NCT00984126|B3|Baseline|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404689|NCT00984126|B2|Baseline|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404690|NCT00984126|B1|Baseline|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
404691|NCT00984126|P4|Participant Flow|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404692|NCT00984126|P3|Participant Flow|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly.On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404693|NCT00984126|P2|Participant Flow|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404694|NCT00984126|P1|Participant Flow|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
404762|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
419182|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
404695|NCT00984126|O7|Outcome|Adults (>=18 Years)-(On-Demand Regimen [Sub-trial])|Subjects (≥18 Years) in sub-trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
404696|NCT00984126|O6|Outcome|Adults (>=18 Years)-(On-Demand Regimen [Main Trial])|Subjects (≥18 Years) in main trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
404697|NCT00984126|O5|Outcome|Adolescents (12-<18 Years)-(On-Demand Regimen [Main Trial])|Subjects (12-<18 Years) in main trial received turoctocog alfa (on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009–30 Jun 2016). On-Demand regimen: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment.
404698|NCT00984126|O4|Outcome|Adults (>= 18 Years) - Preventive Regimen [Main Trial]|Subjects (>=18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: Turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
404699|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years) - Preventive Regimen [Main Trial]|Subjects (12-<18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
404700|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)-Preventive Regimen [Main Trial]|Subjects (6-<12 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
404701|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)-Preventive Regimen [Main Trial]|Subjects (0-<6 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or trial site was terminated by Novo Nordisk or relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009–30 Jun 2016). Preventive regimen: turoctocog alfa as slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly.
404787|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404702|NCT00984126|O4|Outcome|Adults (≥18 Years)-Preventive Regimen [Main Trial]|Subjects (>=18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: Turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
404703|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years)-Preventive Regimen [Main Trial]|Subjects (12-<18 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
404704|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)-Preventive Regimen [Main Trial]|Subjects (6-<12 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009 – 30 Jun 2016). Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg three times weekly or 40−60 IU/kg once every third day or twice weekly.
404705|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)-Preventive Regimen [Main Trial]|Subjects (0-<6 years) in main trial received turoctocog alfa (Preventive regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. However during on-demand sub-trial, it was not possible for new subjects to switch to another regimen, subjects who did not comply with on-demand treatment regimen were to be withdrawn. Subjects coming from main trial were allowed to switch back to main trial before completion of 6 months on-demand treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or trial site was terminated by Novo Nordisk or relevant authority for any reason in relevant country. Maximum treatment duration (27 Oct 2009–30 Jun 2016). Preventive regimen: turoctocog alfa as slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly.
404706|NCT00984126|O4|Outcome|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404707|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404708|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404763|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404709|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
404710|NCT00984126|O4|Outcome|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404711|NCT00984126|O3|Outcome|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404712|NCT00984126|O2|Outcome|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404713|NCT00984126|O1|Outcome|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during the trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in the relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in the relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016)
404714|NCT00984126|E4|Reported Event|Adults (≥18 Years)|Subjects (≥18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until the trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404715|NCT00984126|E3|Reported Event|Adolescents (12 - <18 Years)|Subjects (12-<18 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive regimen: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404764|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404788|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404716|NCT00984126|E2|Reported Event|Older Children (6 - <12 Years)|Subjects (6-<12 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day, 20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404717|NCT00984126|E1|Reported Event|Small Children (0 - <6 Years)|Subjects (0-<6 years) received turoctocog alfa (preventive or on-demand regimen). Subjects switched between regimens during trial (main and on-demand sub-trial) upon investigators’ discretion. Subjects coming from main trial were allowed to switch back before completion of 6 months on-demand regimen. Preventive: turoctocog alfa as a slow iv bolus injection 20−50 IU/kg once every second day,20−60 IU/kg 3 times weekly or 40−60 IU/kg once every third day or twice weekly. On-Demand: Dose level aimed at a post injection level of at least 0.50 IU/mL of turoctocog alfa for treatment of bleeds as they occurred and occasionally as preventive treatment. All subjects were offered participation until either turoctocog alfa was commercially available in relevant country or until trial, part of trial or a trial site was terminated by Novo Nordisk or a relevant authority for any reason in relevant country. The maximum treatment duration (27 Oct 2009 - 30 Jun 2016).
404718|NCT00984061|B1|Baseline|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
404719|NCT00984061|P1|Participant Flow|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
404720|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
404721|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
404722|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
404723|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
404724|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
404725|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
404726|NCT00984061|E3|Reported Event|Colchicine With Clarithromycin|On the morning of Day 29 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with the last dose of clarithromycin.
404727|NCT00984061|E2|Reported Event|Clarithromycin Alone|On the evening of Day 22, subjects began taking (on an outpatient basis) one tablet of clarithromycin 250 mg every 12 hours for 7 days without regard to meals.
404728|NCT00984061|E1|Reported Event|Colchicine Alone|On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg.
404729|NCT00984022|B3|Baseline|Total|Total of all reporting groups
404730|NCT00984022|B2|Baseline|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
404731|NCT00984022|B1|Baseline|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
404732|NCT00984022|P2|Participant Flow|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
404733|NCT00984022|P1|Participant Flow|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
404734|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
404735|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
404736|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
404737|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
404742|NCT00984009|B1|Baseline|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
404743|NCT00984009|P1|Participant Flow|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
404744|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
404745|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404746|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
404747|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404748|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
404749|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404750|NCT00984009|E3|Reported Event|Colchicine With Grapefruit Juice|On Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
404751|NCT00984009|E2|Reported Event|Grapefruit Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals.
404752|NCT00984009|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404753|NCT00983983|B4|Baseline|Total|Total of all reporting groups
404754|NCT00983983|B3|Baseline|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404755|NCT00983983|B2|Baseline|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404756|NCT00983983|B1|Baseline|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404757|NCT00983983|P3|Participant Flow|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404758|NCT00983983|P2|Participant Flow|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404759|NCT00983983|P1|Participant Flow|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404760|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404761|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404824|NCT00983918|P4|Participant Flow|Propofol|General Anesthesia with Propofol
404825|NCT00983918|P3|Participant Flow|Isoflurane|General Anesthesia with Isoflurane
404765|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404766|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404767|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404768|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404769|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404770|NCT00983983|O2|Outcome|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404771|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404772|NCT00983983|E3|Reported Event|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404773|NCT00983983|E2|Reported Event|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404774|NCT00983983|E1|Reported Event|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
404775|NCT00983957|B1|Baseline|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404776|NCT00983957|P1|Participant Flow|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404777|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404778|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404779|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404780|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404781|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404782|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404783|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404784|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404785|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404786|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404826|NCT00983918|P2|Participant Flow|Sevoflurane|General Anesthesia with Sevoflurane
404827|NCT00983918|P1|Participant Flow|Desflurane|General Anesthesia with Desflurane
404789|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404790|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404791|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404792|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404793|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404794|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404795|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404796|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404797|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404798|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404799|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404800|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404801|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404802|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
404803|NCT00983957|E6|Reported Event|Ortho Tri-Cyclen + Daclatasvir Days 68-77|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67 along with daclatasvir two tablets of 30-mg, orally, once daily from Day 68 to 77.
404804|NCT00983957|E5|Reported Event|Ortho Tri-Cyclen Days 57-67|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67.
404805|NCT00983957|E4|Reported Event|Ortho Tri-Cyclen Days 47-56|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 47 to 56.
404806|NCT00983957|E3|Reported Event|Ortho Tri-Cyclen Days 29-46|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 46.
404807|NCT00983957|E2|Reported Event|Ortho Tri-Cyclen Days 1-28|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28.
404808|NCT00983957|E1|Reported Event|All Treated Participants|Participants received sequentially Treatment A: Ortho Tri-Cyclen (OTC) fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 along with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
404809|NCT00983931|B1|Baseline|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
404810|NCT00983931|P1|Participant Flow|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
404811|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
404812|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404813|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
404814|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404815|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
404816|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404817|NCT00983931|E2|Reported Event|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
404818|NCT00983931|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
404819|NCT00983918|B5|Baseline|Total|Total of all reporting groups
404820|NCT00983918|B4|Baseline|Propofol|General Anesthesia with Propofol
404821|NCT00983918|B3|Baseline|Isoflurane|General Anesthesia with Isoflurane
404822|NCT00983918|B2|Baseline|Sevoflurane|General Anesthesia with Sevoflurane
404823|NCT00983918|B1|Baseline|Desflurane|General Anesthesia with Desflurane
404836|NCT00983905|B1|Baseline|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
404837|NCT00983905|P1|Participant Flow|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
404838|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
404839|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
404840|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
404841|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
404842|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
404843|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
404844|NCT00983905|E3|Reported Event|Theophylline With Steady-state Colchicine|On Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45 am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
404845|NCT00983905|E2|Reported Event|Colchicine Alone|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals.
404846|NCT00983905|E1|Reported Event|Theophylline Alone|Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
404847|NCT00983892|B3|Baseline|Total|Total of all reporting groups
404848|NCT00983892|B2|Baseline|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
404849|NCT00983892|B1|Baseline|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
404850|NCT00983892|P2|Participant Flow|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
404851|NCT00983892|P1|Participant Flow|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
404852|NCT00983892|O2|Outcome|Control|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
404853|NCT00983892|O1|Outcome|CarePartners Intervention +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
404854|NCT00983892|E2|Reported Event|CarePartners-|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
404855|NCT00983892|E1|Reported Event|CarePartners+|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
404856|NCT00983853|B7|Baseline|Total|Total of all reporting groups
404912|NCT00983749|B2|Baseline|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
404857|NCT00983853|B6|Baseline|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404858|NCT00983853|B5|Baseline|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404859|NCT00983853|B4|Baseline|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404860|NCT00983853|B3|Baseline|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404861|NCT00983853|B2|Baseline|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404862|NCT00983853|B1|Baseline|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404863|NCT00983853|P6|Participant Flow|Part B: ATV/R-based HAART + Pbo/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
404864|NCT00983853|P5|Participant Flow|Part B: ATV/R-based HAART + T/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
404865|NCT00983853|P4|Participant Flow|Part B: EFV-based HAART + Pbo/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
404866|NCT00983853|P3|Participant Flow|Part B: EFV-based HAART + T/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
404867|NCT00983853|P2|Participant Flow|Part A: Pbo/PR|"Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
404868|NCT00983853|P1|Participant Flow|Part A: T/PR|"Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
404869|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404870|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404871|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404872|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
404873|NCT00983853|O2|Outcome|ATV/R-based (Test, N=13) vs No HAART (Reference, N=7)|
404874|NCT00983853|O1|Outcome|EFV-based (Test, N=15) vs No HAART (Reference, N=7)|
404875|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404876|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404877|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
419183|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
404878|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404879|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404880|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404881|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404882|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404883|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404884|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404885|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404886|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404887|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404888|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404889|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404890|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
404891|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404892|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
404893|NCT00983853|E2|Reported Event|Total PR|Pooled PR from Part A and Part B
404894|NCT00983853|E1|Reported Event|T/PR|Pooled T/PR from Part A and Part B
404895|NCT00983827|B1|Baseline|Aquatic Treadmill Training|
404896|NCT00983827|P1|Participant Flow|Aquatic Treadmill Training|Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.
404897|NCT00983827|O1|Outcome|Aquatic Treadmill Training|
404898|NCT00983827|E1|Reported Event|Aquatic Treadmill Training|
404899|NCT00983801|B1|Baseline|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404900|NCT00983801|P1|Participant Flow|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404901|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404902|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404903|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404904|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404905|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404906|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404907|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404908|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404909|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404910|NCT00983801|E1|Reported Event|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
404913|NCT00983749|B1|Baseline|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
404914|NCT00983749|P2|Participant Flow|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
404915|NCT00983749|P1|Participant Flow|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
404916|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
404917|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
404918|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
404919|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
404920|NCT00983749|E2|Reported Event|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
404921|NCT00983749|E1|Reported Event|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
404922|NCT00983645|B3|Baseline|Total|Total of all reporting groups
404923|NCT00983645|B2|Baseline|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
404924|NCT00983645|B1|Baseline|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
404925|NCT00983645|P2|Participant Flow|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
404926|NCT00983645|P1|Participant Flow|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
404927|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
404928|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
404929|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
404930|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
404931|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
404932|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
404933|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
404934|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
404935|NCT00983645|E2|Reported Event|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
404936|NCT00983645|E1|Reported Event|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
404937|NCT00983580|B3|Baseline|Total|Total of all reporting groups
404938|NCT00983580|B2|Baseline|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404939|NCT00983580|B1|Baseline|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
404940|NCT00983580|P2|Participant Flow|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404941|NCT00983580|P1|Participant Flow|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO once daily on days 1-28.
404942|NCT00983580|O2|Outcome|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404943|NCT00983580|O1|Outcome|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
404944|NCT00983580|O1|Outcome|All Patients|Patients from Arm I and Arm II were combined in this analysis
404945|NCT00983580|O2|Outcome|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404946|NCT00983580|O1|Outcome|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
404947|NCT00983580|O2|Outcome|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404948|NCT00983580|O1|Outcome|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
404949|NCT00983580|O2|Outcome|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404950|NCT00983580|O1|Outcome|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
404951|NCT00983580|O1|Outcome|All Patients|Patients from Arm I and Arm II were combined in this analysis
404952|NCT00983580|O2|Outcome|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404953|NCT00983580|O1|Outcome|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
404954|NCT00983580|E2|Reported Event|Arm II (Placebo)|Patients receive corresponding placebo PO daily on days 1-28.
404955|NCT00983580|E1|Reported Event|Arm I (Acetylsalicylic Acid and Eflornithine)|Patients receive 325 mg acetylsalicylic acid PO once daily and 500 mg eflornithine PO daily on days 1-28.
404956|NCT00983541|B1|Baseline|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
404957|NCT00983541|P1|Participant Flow|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
404958|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404959|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404960|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404961|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404962|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404963|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404964|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404965|NCT00983541|E1|Reported Event|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
404966|NCT00983515|B1|Baseline|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
404967|NCT00983515|P1|Participant Flow|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
404968|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
404969|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
404970|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
404971|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
404972|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
404973|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
404974|NCT00983515|E3|Reported Event|Colchicine With Steady-state Ritonavir|On Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
404975|NCT00983515|E2|Reported Event|Ritonavir Alone|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals.
405319|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
404976|NCT00983515|E1|Reported Event|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
404977|NCT00983489|B4|Baseline|Total|Total of all reporting groups
404978|NCT00983489|B3|Baseline|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
404979|NCT00983489|B2|Baseline|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
404980|NCT00983489|B1|Baseline|Counselling|counselling: Breast feeding counselling will be done to mothers
404981|NCT00983489|P3|Participant Flow|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
404982|NCT00983489|P2|Participant Flow|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
404983|NCT00983489|P1|Participant Flow|Counselling|counselling: Breast feeding counselling will be done to mothers
404984|NCT00983489|O3|Outcome|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
404985|NCT00983489|O2|Outcome|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
404986|NCT00983489|O1|Outcome|Counselling|counselling: Breast feeding counselling will be done to mothers
404987|NCT00983489|E3|Reported Event|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
404988|NCT00983489|E2|Reported Event|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
404989|NCT00983489|E1|Reported Event|Counselling|counselling: Breast feeding counselling will be done to mothers
404990|NCT00983476|B4|Baseline|Total|Total of all reporting groups
404991|NCT00983476|B3|Baseline|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
404992|NCT00983476|B2|Baseline|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
404993|NCT00983476|B1|Baseline|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
404994|NCT00983476|P3|Participant Flow|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
404995|NCT00983476|P2|Participant Flow|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
404996|NCT00983476|P1|Participant Flow|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
404997|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
404998|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
404999|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
405000|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405001|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
405002|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
405003|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405004|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405005|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405006|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405007|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405008|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405009|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405010|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405011|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405012|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405013|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405320|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
405014|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405015|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405016|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405017|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405018|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405019|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
405020|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
405021|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405022|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405023|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
405024|NCT00983476|E3|Reported Event|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
405025|NCT00983476|E2|Reported Event|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
405026|NCT00983476|E1|Reported Event|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
405027|NCT00983437|B1|Baseline|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405028|NCT00983437|P1|Participant Flow|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405029|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405030|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405031|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405032|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405033|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405034|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405035|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405036|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405037|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405038|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405039|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405040|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405041|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405042|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405043|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405044|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405045|NCT00983437|E1|Reported Event|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
405046|NCT00983385|B1|Baseline|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405047|NCT00983385|P1|Participant Flow|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405105|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405321|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
405048|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
405049|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at end of Week 6 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
405050|NCT00983385|O1|Outcome|Tapentadol|Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.
405051|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in PainDetect specific subgroup of participants that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
405052|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 6 in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
405053|NCT00983385|O1|Outcome|Tapentadol|"Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
405054|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405055|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405056|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405057|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405106|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405322|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
405058|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405059|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405060|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405061|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405062|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405063|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405064|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405065|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405066|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405067|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405068|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405069|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405070|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405071|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405072|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405073|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405074|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405075|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405076|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
405077|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
405078|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
405079|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
405080|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
405081|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
405082|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
405083|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
405084|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
405085|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405107|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405323|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
419184|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
405086|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405087|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405088|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405089|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405090|NCT00983385|E1|Reported Event|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405091|NCT00983372|B1|Baseline|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
405092|NCT00983372|P1|Participant Flow|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
405093|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
405094|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
405095|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
405096|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
405097|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
405098|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
405099|NCT00983372|E3|Reported Event|Colchicine With Steady-state Diltiazem|On Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
405100|NCT00983372|E2|Reported Event|Diltiazem Alone|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m.
405101|NCT00983372|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
405102|NCT00983359|B1|Baseline|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405103|NCT00983359|P1|Participant Flow|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405104|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405108|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405109|NCT00983359|E1|Reported Event|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
405110|NCT00983346|B1|Baseline|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
405111|NCT00983346|P1|Participant Flow|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
405112|NCT00983346|O1|Outcome|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
405113|NCT00983346|E1|Reported Event|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
405114|NCT00983307|B1|Baseline|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
405115|NCT00983307|P1|Participant Flow|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
405116|NCT00983307|O1|Outcome|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
405117|NCT00983307|E1|Reported Event|Erlotinib and Radiotherapy|"Patients will be treated with Erlotinib and hypofractionated radiotherapy.~Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.~Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity."
405118|NCT00983294|B1|Baseline|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
405119|NCT00983294|P1|Participant Flow|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30 am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250mg azithromycin tablet at 7:30 am after an overnight fast.
405120|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
405121|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
405122|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
405123|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
405124|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
405125|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
405126|NCT00983294|E3|Reported Event|Colchicine With Steady-state Azithromycin|On Day 19, each subject received both one 0.6mg colchicine tablet and one 250mg azithromycin tablet at 07:30 after an overnight fast.
405127|NCT00983294|E2|Reported Event|Azithromycin Alone|On Day 15, each subject received two 250mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250mg azithromycin tablet daily at 07:30 without regard to meals on Days 16 to 18.
405128|NCT00983294|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days.
405129|NCT00983281|B3|Baseline|Total|Total of all reporting groups
405130|NCT00983281|B2|Baseline|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
405131|NCT00983281|B1|Baseline|Hextend|Patients that received Hextend as part of their resuscitation fluid.
405132|NCT00983281|P2|Participant Flow|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
405133|NCT00983281|P1|Participant Flow|Hextend|Patients that received Hextend as part of their resuscitation fluid.
405134|NCT00983281|O2|Outcome|Standard of Care|PAtients that did not receive Hextend as part of their resuscitation fluid.
405135|NCT00983281|O1|Outcome|Hextend|Patients that received Hextend as part of their resuscitation fluid.
405136|NCT00983281|E2|Reported Event|Standard of Care|Patients that received standard resuscitation but no Hextend as part of their resuscitation.
405137|NCT00983281|E1|Reported Event|Hextend|Patients that received Hextend as part of their resuscitation fluid.
405138|NCT00983242|B1|Baseline|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
405139|NCT00983242|P1|Participant Flow|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
405140|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
405141|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
405142|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
405143|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
405144|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
405145|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
405146|NCT00983242|E3|Reported Event|Colchicine With Verapamil HCl ER|At 8am on Day 19 following a 10 hour fast all subjects received one dose of verapamil HCl ER 240 mg along with one dose of colchicine 0.6 mg.
405147|NCT00983242|E2|Reported Event|Verapamil HCl ER|At 8am on Days 15-18 all subjects received a dose of verapamil HCl ER 240 mg without regard to meals.
405148|NCT00983242|E1|Reported Event|Colchicine Alone|At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
405149|NCT00983216|B1|Baseline|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
405258|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405150|NCT00983216|P1|Participant Flow|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
405151|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
405152|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
405153|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
405154|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
405155|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
405156|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
405157|NCT00983216|E3|Reported Event|Colchicine With Ketoconazole (at Steady-state)|On the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
405158|NCT00983216|E2|Reported Event|Ketoconazole Alone|On Day 15 to 18, subjects took ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals.
405159|NCT00983216|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
405160|NCT00983073|B1|Baseline|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405161|NCT00983073|P1|Participant Flow|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405162|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405163|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405164|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405165|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405313|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
405166|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with either 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405167|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405168|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405169|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405170|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405171|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405172|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405173|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405174|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405175|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405176|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405177|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405178|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405179|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405180|NCT00983073|E1|Reported Event|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405181|NCT00982995|B1|Baseline|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
405182|NCT00982995|P1|Participant Flow|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
405183|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
405184|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
405185|NCT00982995|E1|Reported Event|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
405186|NCT00982735|B1|Baseline|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
405187|NCT00982735|P1|Participant Flow|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
405188|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
405189|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
405190|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
405191|NCT00982735|E1|Reported Event|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
405192|NCT00982657|B5|Baseline|Total|Total of all reporting groups
405193|NCT00982657|B4|Baseline|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405194|NCT00982657|B3|Baseline|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405195|NCT00982657|B2|Baseline|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405196|NCT00982657|B1|Baseline|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405197|NCT00982657|P4|Participant Flow|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405198|NCT00982657|P3|Participant Flow|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405199|NCT00982657|P2|Participant Flow|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405200|NCT00982657|P1|Participant Flow|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405201|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405202|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405203|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405204|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405205|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405206|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405207|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405208|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405209|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405210|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405211|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405212|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405213|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405314|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
405214|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405215|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent occurred or investigator's discretion.
405216|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405217|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
405218|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
405219|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
405220|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405221|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405222|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405223|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405224|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405225|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405226|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405227|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405228|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405229|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405230|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405231|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405232|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405233|NCT00982657|O1|Outcome|All Participants|All participants who received 6 mg/kg, 12mg/kg or 15 mg/kg of CVX-060 intravenous infusion along with oral 50 mg or 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405315|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
419185|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
405234|NCT00982657|E4|Reported Event|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405235|NCT00982657|E3|Reported Event|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405236|NCT00982657|E2|Reported Event|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405237|NCT00982657|E1|Reported Event|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
405238|NCT00982644|B3|Baseline|Total|Total of all reporting groups
405239|NCT00982644|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405240|NCT00982644|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405241|NCT00982644|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405242|NCT00982644|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405243|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405244|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405245|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405246|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405247|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405248|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405249|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405250|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405251|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405252|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405253|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405254|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405255|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405256|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405257|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405259|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405260|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405261|NCT00982644|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405262|NCT00982644|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
405263|NCT00982592|B3|Baseline|Total|Total of all reporting groups
405264|NCT00982592|B2|Baseline|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405265|NCT00982592|B1|Baseline|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405266|NCT00982592|P2|Participant Flow|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405267|NCT00982592|P1|Participant Flow|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405268|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405269|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405270|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405271|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405272|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405273|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405274|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405275|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405276|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405277|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405278|NCT00982592|E2|Reported Event|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405279|NCT00982592|E1|Reported Event|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
405280|NCT00982553|B1|Baseline|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
405281|NCT00982553|P1|Participant Flow|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
405440|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
405282|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
405283|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
405284|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
405285|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
405286|NCT00982553|E1|Reported Event|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
405287|NCT00982488|B6|Baseline|Total|Total of all reporting groups
405288|NCT00982488|B5|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405289|NCT00982488|B4|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405290|NCT00982488|B3|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405291|NCT00982488|B2|Baseline|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405292|NCT00982488|B1|Baseline|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405293|NCT00982488|P5|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405294|NCT00982488|P4|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405295|NCT00982488|P3|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405296|NCT00982488|P2|Participant Flow|Imatinib, 400 mg BID, Chronic Phase|Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405316|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
405317|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
405318|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
419186|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
405297|NCT00982488|P1|Participant Flow|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405298|NCT00982488|O5|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405299|NCT00982488|O4|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405300|NCT00982488|O3|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405301|NCT00982488|O2|Outcome|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib twice daily (BID). Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405302|NCT00982488|O1|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405303|NCT00982488|E5|Reported Event|Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405304|NCT00982488|E4|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405305|NCT00982488|E3|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405306|NCT00982488|E2|Reported Event|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405307|NCT00982488|E1|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
405308|NCT00982423|B3|Baseline|Total|Total of all reporting groups
405309|NCT00982423|B2|Baseline|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
405310|NCT00982423|B1|Baseline|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
405311|NCT00982423|P2|Participant Flow|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
405312|NCT00982423|P1|Participant Flow|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
405324|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
405325|NCT00982423|E2|Reported Event|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
405326|NCT00982423|E1|Reported Event|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
405327|NCT00982410|B3|Baseline|Total|Total of all reporting groups
405328|NCT00982410|B2|Baseline|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405329|NCT00982410|B1|Baseline|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405330|NCT00982410|P2|Participant Flow|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405331|NCT00982410|P1|Participant Flow|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405332|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405333|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405334|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405335|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405336|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405337|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405338|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405401|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405441|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
405339|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405340|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405341|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405342|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405343|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405344|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405345|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405346|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405347|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405348|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405349|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405350|NCT00982410|E2|Reported Event|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
405402|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405442|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
405351|NCT00982410|E1|Reported Event|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
405352|NCT00982397|B3|Baseline|Total|Total of all reporting groups
405353|NCT00982397|B2|Baseline|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
405354|NCT00982397|B1|Baseline|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
405355|NCT00982397|P2|Participant Flow|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
405356|NCT00982397|P1|Participant Flow|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
405357|NCT00982397|O2|Outcome|30/40 NID|Secondary prevention subjects in Phase II randomized to 30/40 NID. (30/40 NID indicates the number of intervals used to detect VF was programmed to 30 of 40 intervals).
405358|NCT00982397|O1|Outcome|18/24 NID|Secondary prevention subjects in Phase II randomized to 18/24 NID. (18/24 NID indicates the number of intervals used to detect VF was programmed to 18 of 24 intervals).
405359|NCT00982397|O1|Outcome|Phase I|Subjects enrolled in Phase I of the study (Protecta).
405360|NCT00982397|O1|Outcome|Phase I|Subjects enrolled in Phase I of the study (Protecta).
405361|NCT00982397|O2|Outcome|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
405362|NCT00982397|O1|Outcome|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
405363|NCT00982397|E2|Reported Event|VR-ICD|Patients implanted with a single-chamber ICD (VR-ICD).
405364|NCT00982397|E1|Reported Event|DR-ICD/CRT-D|Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
405365|NCT00982345|B1|Baseline|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
405366|NCT00982345|P1|Participant Flow|Seroquel XR|Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment.
405367|NCT00982345|O1|Outcome|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
405368|NCT00982345|E1|Reported Event|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
405369|NCT00982280|B1|Baseline|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405370|NCT00982280|P1|Participant Flow|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405371|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405372|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405373|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405374|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405375|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405376|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405377|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405378|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405379|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405380|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405381|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405382|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405383|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405384|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405403|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
419187|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
405385|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405386|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405387|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405388|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405389|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405390|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405391|NCT00982280|E1|Reported Event|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
405392|NCT00982228|B3|Baseline|Total|Total of all reporting groups
405393|NCT00982228|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405394|NCT00982228|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405395|NCT00982228|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405396|NCT00982228|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405397|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405398|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405399|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405400|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405404|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405405|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405406|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405407|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405408|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405409|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405410|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405411|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405412|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405413|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405414|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405415|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405416|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405417|NCT00982228|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
405418|NCT00982228|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
405419|NCT00982189|B5|Baseline|Total|Total of all reporting groups
405420|NCT00982189|B4|Baseline|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
405421|NCT00982189|B3|Baseline|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
405422|NCT00982189|B2|Baseline|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
405423|NCT00982189|B1|Baseline|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
405424|NCT00982189|P4|Participant Flow|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
405425|NCT00982189|P3|Participant Flow|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
405426|NCT00982189|P2|Participant Flow|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
405427|NCT00982189|P1|Participant Flow|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
405428|NCT00982189|O1|Outcome|Lisinopril/L-placebo Treatment Effect|Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
405429|NCT00982189|O1|Outcome|Lisinopril/L-placebo Treatment Effect|Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
405430|NCT00982189|O1|Outcome|Lisinopril/L-placebo Treatment Effect|Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
405431|NCT00982189|O1|Outcome|Lisinopril/L-placebo Treatment Effect|Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
405432|NCT00982189|O1|Outcome|Pravastatin/P-placebo Treatment Effect|Pravastatin vs. Pravastatin-placebo (regardless of Lisinopril status)
405433|NCT00982189|O1|Outcome|Lisinopril/L-placebo Treatment Effect|Lisinopril vs. Lisinopril-placebo (regardless of Pravastatin status)
405434|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
405435|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
405436|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
405437|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
405438|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
405439|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
405444|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
405445|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
405446|NCT00982189|E4|Reported Event|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
405447|NCT00982189|E3|Reported Event|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
405448|NCT00982189|E2|Reported Event|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
405449|NCT00982189|E1|Reported Event|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
405450|NCT00982137|B5|Baseline|Total|Total of all reporting groups
405451|NCT00982137|B4|Baseline|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
405452|NCT00982137|B3|Baseline|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
405453|NCT00982137|B2|Baseline|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
405454|NCT00982137|B1|Baseline|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
405455|NCT00982137|P4|Participant Flow|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
405456|NCT00982137|P3|Participant Flow|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
405457|NCT00982137|P2|Participant Flow|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
405458|NCT00982137|P1|Participant Flow|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
405459|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
405460|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
405461|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
405462|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
405463|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
405464|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
405465|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-JE on Day 30.
405466|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
405467|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
405468|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
405469|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
405470|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
405471|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
405472|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
405473|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
405474|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
405475|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
405476|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
405477|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
405478|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
405479|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL|Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
405480|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
405481|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
405482|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
405483|NCT00982137|E4|Reported Event|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
405484|NCT00982137|E3|Reported Event|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
405485|NCT00982137|E2|Reported Event|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
405486|NCT00982137|E1|Reported Event|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
405487|NCT00982111|B3|Baseline|Total|Total of all reporting groups
405488|NCT00982111|B2|Baseline|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405489|NCT00982111|B1|Baseline|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405490|NCT00982111|P2|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
405491|NCT00982111|P1|Participant Flow|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.~Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
405492|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405493|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405494|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405495|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405496|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405497|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405498|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405499|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405500|NCT00982111|O1|Outcome|Necitumumab + Pemextrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405501|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405502|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405503|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405504|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405505|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405506|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405507|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405508|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405509|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405510|NCT00982111|E2|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405511|NCT00982111|E1|Reported Event|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
405512|NCT00982033|B3|Baseline|Total|Total of all reporting groups
405513|NCT00982033|B2|Baseline|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
405514|NCT00982033|B1|Baseline|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
405515|NCT00982033|P2|Participant Flow|Placebo|"50% of subjects will be randomized to placebo.~placebo: placebo qd for 24 weeks"
405516|NCT00982033|P1|Participant Flow|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.~aliskiren: aliskiren 300mg qd versus placebo for 24 weeks."
405517|NCT00982033|O2|Outcome|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
405518|NCT00982033|O1|Outcome|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
405519|NCT00982033|E2|Reported Event|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
405520|NCT00982033|E1|Reported Event|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
405521|NCT00982020|B3|Baseline|Total|Total of all reporting groups
405522|NCT00982020|B2|Baseline|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
405523|NCT00982020|B1|Baseline|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
405524|NCT00982020|P2|Participant Flow|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
405525|NCT00982020|P1|Participant Flow|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
405526|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
405527|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
405528|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
405529|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
405530|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
405607|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405531|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
405532|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
405533|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
405534|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
405535|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
405536|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
405537|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
405538|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
405539|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
405540|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
405541|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
405542|NCT00982020|E2|Reported Event|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
405543|NCT00982020|E1|Reported Event|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
405544|NCT00982007|B5|Baseline|Total|Total of all reporting groups
405545|NCT00982007|B4|Baseline|Cohort 2 (Group D) - IV Iron (Standard of Care)|Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
405546|NCT00982007|B3|Baseline|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405547|NCT00982007|B2|Baseline|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
405548|NCT00982007|B1|Baseline|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405549|NCT00982007|P4|Participant Flow|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
405550|NCT00982007|P3|Participant Flow|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405551|NCT00982007|P2|Participant Flow|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
405552|NCT00982007|P1|Participant Flow|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405553|NCT00982007|O4|Outcome|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
405554|NCT00982007|O3|Outcome|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405555|NCT00982007|O2|Outcome|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
405556|NCT00982007|O1|Outcome|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405557|NCT00982007|E4|Reported Event|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
405558|NCT00982007|E3|Reported Event|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405559|NCT00982007|E2|Reported Event|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
405560|NCT00982007|E1|Reported Event|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
405561|NCT00981825|B3|Baseline|Total|Total of all reporting groups
405562|NCT00981825|B2|Baseline|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)
405563|NCT00981825|B1|Baseline|Fluoride 1st, Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)
405564|NCT00981825|P2|Participant Flow|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
405565|NCT00981825|P1|Participant Flow|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
405566|NCT00981825|O2|Outcome|Triclosan/Fluoride Toothpaste|Triclosan/Fluoride toothpaste (experimental)
405567|NCT00981825|O1|Outcome|Fluoride Toothpaste (Control)|Fluoride toothpaste (control)
405568|NCT00981825|E2|Reported Event|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
405569|NCT00981825|E1|Reported Event|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
405570|NCT00981812|B1|Baseline|Primary|Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.
405571|NCT00981812|P1|Participant Flow|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
405572|NCT00981812|O1|Outcome|Lesions Visualized Using Positron Emission Mammography (PEM)|Total lesions visualized using positron emission mammography.
405573|NCT00981812|E1|Reported Event|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
405574|NCT00981669|B3|Baseline|Total|Total of all reporting groups
405575|NCT00981669|B2|Baseline|Placebo|3 doses with 6 weeks interval
405576|NCT00981669|B1|Baseline|Rotavirus Vaccine|3 doses with 6 weeks interval
405577|NCT00981669|P2|Participant Flow|Placebo|3 doses with 6 weeks interval
405578|NCT00981669|P1|Participant Flow|Rotavirus Vaccine|3 doses with 6 weeks interval
405579|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
405580|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
405581|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
405582|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
405583|NCT00981669|E2|Reported Event|Placebo|3 doses with 6 weeks interval
405584|NCT00981669|E1|Reported Event|Rotavirus Vaccine|3 doses with 6 weeks interval
405585|NCT00981630|B5|Baseline|Total|Total of all reporting groups
405586|NCT00981630|B4|Baseline|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405587|NCT00981630|B3|Baseline|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405588|NCT00981630|B2|Baseline|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405589|NCT00981630|B1|Baseline|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405590|NCT00981630|P4|Participant Flow|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405591|NCT00981630|P3|Participant Flow|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405592|NCT00981630|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405593|NCT00981630|P1|Participant Flow|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405594|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405595|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405596|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405597|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405598|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405599|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405600|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405601|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405602|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405603|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405604|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405605|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405606|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405665|NCT00981370|P1|Participant Flow|Group One|No enrollment
405608|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405609|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405610|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405611|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405612|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405613|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405614|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405615|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405616|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405617|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405618|NCT00981630|E4|Reported Event|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
405619|NCT00981630|E3|Reported Event|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
405620|NCT00981630|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
405621|NCT00981630|E1|Reported Event|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
405622|NCT00981461|B3|Baseline|Total|Total of all reporting groups
405623|NCT00981461|B2|Baseline|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.
405624|NCT00981461|B1|Baseline|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner
405625|NCT00981461|P2|Participant Flow|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
405626|NCT00981461|P1|Participant Flow|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
405627|NCT00981461|O2|Outcome|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
405628|NCT00981461|O1|Outcome|Control Device|This control device is inactive emitting white light
405629|NCT00981461|E2|Reported Event|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
405630|NCT00981461|E1|Reported Event|Control Device|This control device is inactive emitting white light
405631|NCT00981435|B4|Baseline|Total|Total of all reporting groups
405632|NCT00981435|B3|Baseline|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
405633|NCT00981435|B2|Baseline|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
405634|NCT00981435|B1|Baseline|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
405635|NCT00981435|P3|Participant Flow|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
405636|NCT00981435|P2|Participant Flow|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
405637|NCT00981435|P1|Participant Flow|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
405638|NCT00981435|O3|Outcome|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
405639|NCT00981435|O2|Outcome|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
405640|NCT00981435|O1|Outcome|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
405641|NCT00981435|O3|Outcome|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
405642|NCT00981435|O2|Outcome|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
405643|NCT00981435|O1|Outcome|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
405644|NCT00981435|E3|Reported Event|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
405645|NCT00981435|E2|Reported Event|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
405646|NCT00981435|E1|Reported Event|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
405647|NCT00981409|B3|Baseline|Total|Total of all reporting groups
405648|NCT00981409|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405666|NCT00981370|O1|Outcome|Group 1|First group of subjects enrolled.
405667|NCT00981370|E1|Reported Event|Group 1|No patients enrolled
405668|NCT00981305|B3|Baseline|Total|Total of all reporting groups
405649|NCT00981409|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405650|NCT00981409|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405651|NCT00981409|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405652|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405653|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405654|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405655|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405656|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405657|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405658|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405659|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405660|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405661|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405662|NCT00981409|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
405663|NCT00981409|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
405664|NCT00981370|B1|Baseline|Group 1|First group of subjects to be enrolled.
405669|NCT00981305|B2|Baseline|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405670|NCT00981305|B1|Baseline|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405671|NCT00981305|P2|Participant Flow|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405672|NCT00981305|P1|Participant Flow|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405673|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405674|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405675|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405676|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405677|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405678|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405679|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405680|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405681|NCT00981305|E2|Reported Event|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405682|NCT00981305|E1|Reported Event|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
405683|NCT00981292|B7|Baseline|Total|Total of all reporting groups
405684|NCT00981292|B6|Baseline|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
405685|NCT00981292|B5|Baseline|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
405686|NCT00981292|B4|Baseline|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
405687|NCT00981292|B3|Baseline|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
405688|NCT00981292|B2|Baseline|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
405689|NCT00981292|B1|Baseline|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
405690|NCT00981292|P6|Participant Flow|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
405691|NCT00981292|P5|Participant Flow|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
405692|NCT00981292|P4|Participant Flow|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
405693|NCT00981292|P3|Participant Flow|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
405694|NCT00981292|P2|Participant Flow|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
405695|NCT00981292|P1|Participant Flow|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
405696|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
405697|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
405698|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
405699|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
405700|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
405701|NCT00981292|O1|Outcome|135mg|All participants when consumed 135mg EGCG.
405702|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
405703|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
405704|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
405705|NCT00981292|E6|Reported Event|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
405706|NCT00981292|E5|Reported Event|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
405707|NCT00981292|E4|Reported Event|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
405708|NCT00981292|E3|Reported Event|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
405709|NCT00981292|E2|Reported Event|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
405710|NCT00981292|E1|Reported Event|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
405711|NCT00981253|B3|Baseline|Total|Total of all reporting groups
405712|NCT00981253|B2|Baseline|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405713|NCT00981253|B1|Baseline|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405714|NCT00981253|P2|Participant Flow|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405715|NCT00981253|P1|Participant Flow|SMT-Enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405716|NCT00981253|O2|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405717|NCT00981253|O1|Outcome|SMT-Enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405718|NCT00981253|O2|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405719|NCT00981253|O1|Outcome|SMT-Enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405720|NCT00981253|O2|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405721|NCT00981253|O1|Outcome|SMT-Enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405722|NCT00981253|O2|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405723|NCT00981253|O1|Outcome|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405724|NCT00981253|O2|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405725|NCT00981253|O1|Outcome|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405726|NCT00981253|O2|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405727|NCT00981253|O1|Outcome|SMT-Enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405728|NCT00981253|O2|Outcome|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405729|NCT00981253|O1|Outcome|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405730|NCT00981253|E2|Reported Event|Standard Cardiac Rehabilitation|"Standard cardiac rehabilitation consisting of supervised exercise for 12 weeks.~Standard Cardiac Rehabilitation: Supervised exercise, three times per week, for 12 weeks."
405731|NCT00981253|E1|Reported Event|SMT-enhanced Cardiac Rehabilitation|"Standard exercise-based cardiac rehabilitation with weekly stress management training for 12 weeks.~SMT-enhanced Cardiac Rehabilitation: Standard exercise-based cardiac rehabilitation, three times per week, enhanced with weekly stress management training for 12 weeks."
405732|NCT00981227|B7|Baseline|Total|Total of all reporting groups
405733|NCT00981227|B6|Baseline|Placebo|"placebo~Placebo : oral route"
405734|NCT00981227|B5|Baseline|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
405735|NCT00981227|B4|Baseline|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
405736|NCT00981227|B3|Baseline|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
405737|NCT00981227|B2|Baseline|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
405738|NCT00981227|B1|Baseline|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
405739|NCT00981227|P6|Participant Flow|Placebo|"placebo~Placebo : oral route"
405740|NCT00981227|P5|Participant Flow|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
405741|NCT00981227|P4|Participant Flow|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
405742|NCT00981227|P3|Participant Flow|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
405743|NCT00981227|P2|Participant Flow|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
405744|NCT00981227|P1|Participant Flow|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
405745|NCT00981227|O4|Outcome|ESL 800 mg/Day|total daily dose;oral route
405746|NCT00981227|O3|Outcome|ESL 1600 mg/Day|total daily dose;oral route
405747|NCT00981227|O2|Outcome|ESL 1200 mg/Day|total daily dose;oral route
405748|NCT00981227|O1|Outcome|Placebo|"placebo~Placebo : oral route"
405749|NCT00981227|O6|Outcome|Placebo|total daily dose;oral route
405750|NCT00981227|O5|Outcome|ESL 800 mg Twice Daily|total daily dose;oral route
405751|NCT00981227|O4|Outcome|ESL 800 mg Once-daily|total daily dose;oral route
405752|NCT00981227|O3|Outcome|ESL 600 mg Twice Daily|total daily dose;oral route
405753|NCT00981227|O2|Outcome|ESL 400 mg Twice-daily|total daily dose;oral route
405754|NCT00981227|O1|Outcome|ESL 1200 mg Once Daily|total daily dose;oral route
405755|NCT00981227|E6|Reported Event|Placebo|"placebo~Placebo : oral route"
405756|NCT00981227|E5|Reported Event|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
405757|NCT00981227|E4|Reported Event|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
405758|NCT00981227|E3|Reported Event|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
405759|NCT00981227|E2|Reported Event|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
405760|NCT00981227|E1|Reported Event|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
405761|NCT00981214|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405762|NCT00981214|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405763|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405764|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405765|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405766|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405767|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405768|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405769|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405805|NCT00981149|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
407042|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
405770|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405771|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405772|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405773|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405774|NCT00981214|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in capsule was administered orally or sprinkled on food. When required, from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
405775|NCT00981175|B4|Baseline|Total|Total of all reporting groups
405776|NCT00981175|B3|Baseline|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
405777|NCT00981175|B2|Baseline|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
405778|NCT00981175|B1|Baseline|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
405779|NCT00981175|P2|Participant Flow|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
405780|NCT00981175|P1|Participant Flow|ChimeriVax™-JE Vaccine First, Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28.
405781|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at month 6 following primary ChimeriVax™-JE and Diluent vaccination at Day 0 and Day 28
405782|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent) at either Day 0 or Day 28
405783|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
405784|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
405785|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent)at either Day 0 or Day 28
405786|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
405787|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
405788|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
405789|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
405790|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
405791|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
405792|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
405793|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
405794|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
405795|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
405796|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
405797|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
405798|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
405799|NCT00981175|E3|Reported Event|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
405800|NCT00981175|E2|Reported Event|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
405801|NCT00981175|E1|Reported Event|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
405802|NCT00981149|B3|Baseline|Total|Total of all reporting groups
405803|NCT00981149|B2|Baseline|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
405804|NCT00981149|B1|Baseline|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
405806|NCT00981149|P1|Participant Flow|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
405807|NCT00981149|O2|Outcome|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
405808|NCT00981149|O1|Outcome|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
405809|NCT00981149|O2|Outcome|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
405810|NCT00981149|O1|Outcome|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
405811|NCT00981149|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo match duloxetine for 6 week period."
405812|NCT00981149|E1|Reported Event|Duloxetine Study Drug|"Drug~duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period"
405813|NCT00981084|B3|Baseline|Total|Total of all reporting groups
405814|NCT00981084|B2|Baseline|Placebo Then Armodafinil|
405815|NCT00981084|B1|Baseline|Armodafinil Then Placebo|"All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design~armodafinil : Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions."
405816|NCT00981084|P2|Participant Flow|Placebo First and Armodafinil Second|Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
405817|NCT00981084|P1|Participant Flow|Armodafinil First and Placebo Second|Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
405818|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405819|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405820|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405821|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405822|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405823|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405824|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405825|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
405826|NCT00981084|E4|Reported Event|Armodafinil Then Placebo (Placebo)|number of adverse events following placebo in the armodafniil then placebo condition.
405827|NCT00981084|E3|Reported Event|Placebo Then Armodafinil (Armodafinil)|Adverse events following armodafinil in the placebo/armodafinil group
405828|NCT00981084|E2|Reported Event|Armodafinil Then Placebo (Armodafinil)|Adverse events reported after taking armodafinil in the Armodafinil then placebo group
405829|NCT00981084|E1|Reported Event|Placebo Then Armodafinil (Placebo)|Adverse events reported after taking placebo in the Placebo then Armodafinil Group
405830|NCT00981058|B3|Baseline|Total|Total of all reporting groups
405831|NCT00981058|B2|Baseline|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405832|NCT00981058|B1|Baseline|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405833|NCT00981058|P2|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405834|NCT00981058|P1|Participant Flow|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405857|NCT00981045|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
405835|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405836|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405837|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405838|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405839|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405840|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405841|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405842|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405843|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405844|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405845|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405846|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405847|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405848|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405849|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405850|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405851|NCT00981058|E2|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405852|NCT00981058|E1|Reported Event|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
405853|NCT00981045|B3|Baseline|Total|Total of all reporting groups
405854|NCT00981045|B2|Baseline|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
405855|NCT00981045|B1|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
405856|NCT00981045|P2|Participant Flow|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
405858|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
405859|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
405860|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
405861|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
405862|NCT00981045|E2|Reported Event|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
405863|NCT00981045|E1|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
405864|NCT00981019|B1|Baseline|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
405865|NCT00981019|P1|Participant Flow|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
405866|NCT00981019|O1|Outcome|Mortality*Incidence*5-year Survival*Early Detection Rate|The survey introduced four different cancer statistics in scenarios about 2 different screening tests. To mask the fact that all statistics stemmed from prostate cancer screening, screening in the scenarios were labeled “X” and “Z”. The survey then introduced test Z, whose effectiveness was described in terms of a reduction of cancer mortality. After responding to the series of outcome questions about test Z, physicians received additional information on the cancer incidence, again followed by the outcome questions. In the next scenario, the survey introduced test X, whose effectiveness was described in terms of an increase in 5-year survival and, in the next step, with additional information on early detection rates. After each step, doctors had to respond to the same outcome questions as they had for test Z. Please not, information on test X and test Z were randomly presented to control for order effects.
405867|NCT00981019|E1|Reported Event|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
405868|NCT00980980|B4|Baseline|Total|Total of all reporting groups
405869|NCT00980980|B3|Baseline|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405870|NCT00980980|B2|Baseline|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405871|NCT00980980|B1|Baseline|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405872|NCT00980980|P3|Participant Flow|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405873|NCT00980980|P2|Participant Flow|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405874|NCT00980980|P1|Participant Flow|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405875|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405876|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
407043|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
405877|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405878|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405879|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405880|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405881|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405882|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405883|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405884|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405885|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405886|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405887|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405888|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405889|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405890|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405891|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405892|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405893|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405894|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405895|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405896|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405938|NCT00980681|B1|Baseline|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
405994|NCT00980642|B2|Baseline|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
405897|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405898|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
405899|NCT00980980|E3|Reported Event|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405900|NCT00980980|E2|Reported Event|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
405901|NCT00980980|E1|Reported Event|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs Contact Precautions for MRSA+
405902|NCT00980798|B3|Baseline|Total|Total of all reporting groups
405903|NCT00980798|B2|Baseline|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
405904|NCT00980798|B1|Baseline|Placebo|Placebo daily for 16 weeks
405905|NCT00980798|P2|Participant Flow|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
405906|NCT00980798|P1|Participant Flow|Placebo|Placebo daily for 16 weeks
405907|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
405908|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
405909|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
405910|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
405911|NCT00980798|E2|Reported Event|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
405912|NCT00980798|E1|Reported Event|Placebo|Placebo daily for 16 weeks
405913|NCT00980746|B7|Baseline|Total|Total of all reporting groups
405914|NCT00980746|B6|Baseline|Placebo|"Placebo~Placebo : oral route"
405915|NCT00980746|B5|Baseline|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405916|NCT00980746|B4|Baseline|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405917|NCT00980746|B3|Baseline|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405918|NCT00980746|B2|Baseline|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405919|NCT00980746|B1|Baseline|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405920|NCT00980746|P6|Participant Flow|Placebo|"Placebo~Placebo : oral route"
405921|NCT00980746|P5|Participant Flow|ESL 800 mg QD|"ESL 800 mg once-daily~ESL tablets, scored to allow dose titration during the titration period."
405922|NCT00980746|P4|Participant Flow|ESL 800 mg BID|"ESL 800 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
405923|NCT00980746|P3|Participant Flow|ESL 600 mg BID|"ESL 600 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
405924|NCT00980746|P2|Participant Flow|ESL 400 mg BD|"ESL 400 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
405925|NCT00980746|P1|Participant Flow|ESL 1200 mg QD|Eslicarbazepine acetate (ESL) 1200 mg once daily. ESL tablets, scored to allow dose titration during the titration period.
405926|NCT00980746|O6|Outcome|Placebo|"Placebo~Placebo : oral route"
405927|NCT00980746|O5|Outcome|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405928|NCT00980746|O4|Outcome|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405929|NCT00980746|O3|Outcome|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405930|NCT00980746|O2|Outcome|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405931|NCT00980746|O1|Outcome|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405932|NCT00980746|E6|Reported Event|Placebo|"Placebo~Placebo : oral route"
405933|NCT00980746|E5|Reported Event|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405934|NCT00980746|E4|Reported Event|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405935|NCT00980746|E3|Reported Event|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405936|NCT00980746|E2|Reported Event|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
405937|NCT00980746|E1|Reported Event|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
407044|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
405939|NCT00980681|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
405940|NCT00980681|O2|Outcome|Time-Of-Flight MRA|Patients benefiting from an MRA with no injection of contrast medium
405941|NCT00980681|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after administration with Dotarem
405942|NCT00980681|E2|Reported Event|Time Of Flight|"Each subject will undergo a TOF Magnetic Resonance Angiography~Time of Flight: Each subject will undergo a TOF MRA"
405943|NCT00980681|E1|Reported Event|Dotarem|"Each subject will receive one injection of Dotarem 0.2ml/kg.~Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg"
405944|NCT00980655|B3|Baseline|Total|Total of all reporting groups
405945|NCT00980655|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405946|NCT00980655|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405947|NCT00980655|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405948|NCT00980655|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405949|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405950|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405951|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405952|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405953|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405954|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405955|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405956|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405957|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405958|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405995|NCT00980642|B1|Baseline|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
405959|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405960|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405961|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405962|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405963|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405964|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405965|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405966|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405967|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405968|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405969|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405970|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405971|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405972|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405973|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405974|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405992|NCT00980655|E1|Reported Event|13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw|All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.
405993|NCT00980642|B3|Baseline|Total|Total of all reporting groups
405975|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405976|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405977|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405978|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405979|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405980|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405981|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405982|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405983|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405984|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405985|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405986|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405987|NCT00980655|O1|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
405988|NCT00980655|E5|Reported Event|Follow-up|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.
405989|NCT00980655|E4|Reported Event|23vPS Dose|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.
405990|NCT00980655|E3|Reported Event|13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.
405991|NCT00980655|E2|Reported Event|13vPnC Dose 3 Blood Draw to 13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.
419188|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
405996|NCT00980642|P2|Participant Flow|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
405997|NCT00980642|P1|Participant Flow|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
405998|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
405999|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
406000|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
406001|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
406002|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
406003|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery
406004|NCT00980642|E2|Reported Event|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
406005|NCT00980642|E1|Reported Event|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
406006|NCT00980590|B3|Baseline|Total|Total of all reporting groups
406007|NCT00980590|B2|Baseline|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
406008|NCT00980590|B1|Baseline|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
406009|NCT00980590|P2|Participant Flow|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
406010|NCT00980590|P1|Participant Flow|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
406011|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
406012|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
406013|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
406014|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
406015|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
406016|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
406017|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
406018|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
406019|NCT00980590|E2|Reported Event|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
406020|NCT00980590|E1|Reported Event|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
406021|NCT00980343|B3|Baseline|Total|Total of all reporting groups
406022|NCT00980343|B2|Baseline|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406023|NCT00980343|B1|Baseline|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
406024|NCT00980343|P2|Participant Flow|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406025|NCT00980343|P1|Participant Flow|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
406026|NCT00980343|O1|Outcome|Arm 1(Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.~Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406072|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406749|NCT00979303|O1|Outcome|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
406027|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406028|NCT00980343|O1|Outcome|Arm 1(Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.~Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406029|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406030|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
406031|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406032|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
406033|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406034|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
406035|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406036|NCT00980343|O1|Outcome|Arm 1(Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.~Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406037|NCT00980343|O2|Outcome|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406038|NCT00980343|O1|Outcome|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
406039|NCT00980343|E2|Reported Event|Arm II (no Vismodegib Pre-surgery)|"Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies"
406107|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406040|NCT00980343|E1|Reported Event|Arm I (Pre-surgery Vismodegib)|"Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis~vismodegib: Given orally~therapeutic conventional surgery: undergo surgery~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
406041|NCT00980330|B8|Baseline|Total|Total of all reporting groups
406042|NCT00980330|B7|Baseline|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406043|NCT00980330|B6|Baseline|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406044|NCT00980330|B5|Baseline|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406045|NCT00980330|B4|Baseline|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406046|NCT00980330|B3|Baseline|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406047|NCT00980330|B2|Baseline|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406048|NCT00980330|B1|Baseline|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406049|NCT00980330|P7|Participant Flow|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406050|NCT00980330|P6|Participant Flow|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406051|NCT00980330|P5|Participant Flow|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406052|NCT00980330|P4|Participant Flow|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406053|NCT00980330|P3|Participant Flow|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406054|NCT00980330|P2|Participant Flow|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406055|NCT00980330|P1|Participant Flow|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406056|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406057|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406058|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406059|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406060|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406061|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406062|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406063|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406064|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406065|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406066|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406067|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406068|NCT00980330|O7|Outcome|All TMC435|Participants in all 6 TMC435 treatment groups combined.
406069|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406070|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406071|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
407045|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
406073|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406074|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406075|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406076|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406077|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406078|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406079|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406080|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406081|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406082|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406083|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406084|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406085|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406086|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406087|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406088|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406089|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406090|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406091|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406092|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406093|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406094|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406095|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406096|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406097|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406098|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406099|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406100|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406101|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406102|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406103|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406104|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406105|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406106|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406108|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406109|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406110|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406111|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406112|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406113|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406114|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406115|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406116|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406117|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406118|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406119|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406120|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406121|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406122|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406123|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406124|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406125|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406126|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406127|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406128|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406129|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406130|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406131|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406132|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406133|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406134|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406135|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406136|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406137|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406138|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406139|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406140|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406141|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406142|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406143|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406144|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406145|NCT00980330|E7|Reported Event|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406146|NCT00980330|E6|Reported Event|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406147|NCT00980330|E5|Reported Event|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
406148|NCT00980330|E4|Reported Event|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
406149|NCT00980330|E3|Reported Event|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
406150|NCT00980330|E2|Reported Event|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
406151|NCT00980330|E1|Reported Event|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
406152|NCT00980278|B3|Baseline|Total|Total of all reporting groups
406153|NCT00980278|B2|Baseline|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406154|NCT00980278|B1|Baseline|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406155|NCT00980278|P2|Participant Flow|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406156|NCT00980278|P1|Participant Flow|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406157|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406158|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406159|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406160|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406161|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406162|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406163|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406164|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406165|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406166|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406167|NCT00980278|E2|Reported Event|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
406168|NCT00980278|E1|Reported Event|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
406169|NCT00980200|B1|Baseline|PB, GW642444 6.25 µg QD, 6.25 µg BID, 12.5 µg QD, and 25 µg QD|All participants received one of the following five treatments in one of the five Treatment Periods from two DPI dispensed on Day 1of each of the five 7-day treatment periods: Placebo (PB), GW642444 6.25 µg once daily (QD) in the evening, GW642444 6.25 µg twice daily (BID), GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening. Participants received their first evening medication dose in the clinic on Day 1 of each of the five treatment periods. The treatments were administered in the morning (AM) and in the evening (PM), approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a 7-day washout period.
406170|NCT00980200|P5|Participant Flow|Sequence 5: 25 µg QD, 12.5 µg QD, 6.25 µg BID, 6.25 µg QD, Pbo|Participants received GW642444 25 µg QD in the evening, GW642444 12.5 µg QD in the evening, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, and placebo in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
406171|NCT00980200|P4|Participant Flow|Sequence 4: 12.5 µg QD, 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID|Participants received GW642444 12.5 µg QD in the evening, GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, and GW642444 6.25 µg BID and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
406237|NCT00980044|E3|Reported Event|Tramadol 600 mg|Medication: Extended release tramadol 600 mg daily for one week followed by placebo for one week
406238|NCT00980044|E2|Reported Event|Placebo|Medication: Placebo for 2 weeks
406172|NCT00980200|P3|Participant Flow|Sequence 3: 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID, 12.5 µg QD|Participants received GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, GW642444 6.25 µg BID, and GW642444 12.5 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
406173|NCT00980200|P2|Participant Flow|Sequence 2: Pbo, 6.25 µg BID, 6.25 µg QD, 12.5 µg QD, 25 µg QD|Participants received placebo, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
406174|NCT00980200|P1|Participant Flow|Sequence 1: 6.25 µg BID, Pbo, 12.5 µg QD, 25 µg QD, 6.25 µg QD|Participants received GW642444 6.25 micrograms (µg) twice a day (BID), placebo (pbo), GW642444 12.5 µg once a day (QD) in the evening, GW642444 25 µg QD in the evening, and GW642444 6.25 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a Dry Powder Inhaler (DPI) for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
406175|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406176|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406177|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406178|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406179|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
406180|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406181|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406182|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406183|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406184|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
406239|NCT00980044|E1|Reported Event|Tramadol 200 mg|Medication: Extended release tramadol 200 mg daily for one week followed by placebo for one week
406240|NCT00980005|B3|Baseline|Total|Total of all reporting groups
419189|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
406185|NCT00980200|E5|Reported Event|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406186|NCT00980200|E4|Reported Event|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406187|NCT00980200|E3|Reported Event|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406188|NCT00980200|E2|Reported Event|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
406189|NCT00980200|E1|Reported Event|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
406190|NCT00980174|B3|Baseline|Total|Total of all reporting groups
406191|NCT00980174|B2|Baseline|Denosumab 60 mg Q6M|
406192|NCT00980174|B1|Baseline|Placebo|
406193|NCT00980174|P2|Participant Flow|Denosumab 60 mg Q6M|
406194|NCT00980174|P1|Participant Flow|Placebo|
406195|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
406196|NCT00980174|O1|Outcome|Placebo|
406197|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
406198|NCT00980174|O1|Outcome|Placebo|
406199|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
406200|NCT00980174|O1|Outcome|Placebo|
406201|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
406202|NCT00980174|O1|Outcome|Placebo|
406203|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
406204|NCT00980174|O1|Outcome|Placebo|
406205|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
406206|NCT00980174|O1|Outcome|Placebo|
406207|NCT00980174|E2|Reported Event|Denosumab 60 mg Q6M|
406208|NCT00980174|E1|Reported Event|Placebo|
406209|NCT00980148|B3|Baseline|Total|Total of all reporting groups
406210|NCT00980148|B2|Baseline|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
406211|NCT00980148|B1|Baseline|Azithromycin Arm|Azithromycin 1 gm oral single dose
406212|NCT00980148|P2|Participant Flow|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
406213|NCT00980148|P1|Participant Flow|Azithromycin Arm|Azithromycin 1 gm oral single dose
406214|NCT00980148|O2|Outcome|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
406215|NCT00980148|O1|Outcome|Azithromycin Arm|Azithromycin 1 gm oral single dose
406216|NCT00980148|E2|Reported Event|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
406217|NCT00980148|E1|Reported Event|Azithromycin Arm|Azithromycin 1 gm oral single dose
406218|NCT00980044|B4|Baseline|Total|Total of all reporting groups
406219|NCT00980044|B3|Baseline|Tramadol 600 mg|Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week
406220|NCT00980044|B2|Baseline|Placebo|Medication: Placebo given for two weeks
406221|NCT00980044|B1|Baseline|Tramadol 200 mg|Medication: Extended release tramadol for 1 week and then placebo given for 1 week
406222|NCT00980044|P3|Participant Flow|Tramadol 600 mg Daily|Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.
406223|NCT00980044|P2|Participant Flow|Placebo|Placebo given for two weeks
406224|NCT00980044|P1|Participant Flow|Tramadol 200 mg Daily|Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
406225|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
406226|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
406227|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
406228|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
406229|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
406230|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
406231|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
406232|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
406233|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
406234|NCT00980044|O3|Outcome|Tramadol 600 mg Daily|Medication: Extended release tramadol
406235|NCT00980044|O2|Outcome|Placebo|Medication
406236|NCT00980044|O1|Outcome|Tramadol 200 mg Daily|Medication: Extended release tramadol
406241|NCT00980005|B2|Baseline|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406242|NCT00980005|B1|Baseline|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406243|NCT00980005|P2|Participant Flow|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406244|NCT00980005|P1|Participant Flow|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406245|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406246|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406247|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406248|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406249|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406250|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406251|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406252|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406253|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406254|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406255|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406256|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406257|NCT00980005|O4|Outcome|Fluzone 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
406258|NCT00980005|O3|Outcome|Flulaval 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
406259|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406260|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406261|NCT00980005|O4|Outcome|Fluzone Les Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
406262|NCT00980005|O3|Outcome|Flulaval Less Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
406285|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
419190|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
406263|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406264|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406265|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406266|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406267|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406268|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406269|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406270|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406271|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406272|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406273|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406274|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406275|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406276|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406277|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406278|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406279|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406280|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406281|NCT00980005|E2|Reported Event|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
406282|NCT00980005|E1|Reported Event|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
406283|NCT00979992|B1|Baseline|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
406284|NCT00979992|P1|Participant Flow|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
406286|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
406287|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
406288|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
406289|NCT00979992|O1|Outcome|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
406290|NCT00979992|E1|Reported Event|SU11248|SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
406291|NCT00979953|B5|Baseline|Total|Total of all reporting groups
406292|NCT00979953|B4|Baseline|Placebo|Four placebo capsules administered orally BID for 14 days
406293|NCT00979953|B3|Baseline|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
406294|NCT00979953|B2|Baseline|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
406295|NCT00979953|B1|Baseline|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
406296|NCT00979953|P4|Participant Flow|Placebo|Four placebo capsules administered orally BID for 14 days
406297|NCT00979953|P3|Participant Flow|Oxycodone CR|One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
406298|NCT00979953|P2|Participant Flow|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
406299|NCT00979953|P1|Participant Flow|ADL5859|One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
406300|NCT00979953|O4|Outcome|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
406301|NCT00979953|O3|Outcome|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
406302|NCT00979953|O2|Outcome|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID for Days 5 through 14"
406303|NCT00979953|O1|Outcome|Placebo|Four placebo capsules administered orally BID for 14 days
406304|NCT00979953|E4|Reported Event|Placebo|Four placebo capsules administered orally BID for 14 days
406305|NCT00979953|E3|Reported Event|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
406306|NCT00979953|E2|Reported Event|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
406307|NCT00979953|E1|Reported Event|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
406308|NCT00979940|B3|Baseline|Total|Total of all reporting groups
406309|NCT00979940|B2|Baseline|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
406310|NCT00979940|B1|Baseline|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
406311|NCT00979940|P2|Participant Flow|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
406312|NCT00979940|P1|Participant Flow|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
406313|NCT00979940|O2|Outcome|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
406314|NCT00979940|O1|Outcome|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
406315|NCT00979940|E2|Reported Event|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
406316|NCT00979940|E1|Reported Event|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
406317|NCT00979901|B5|Baseline|Total|Total of all reporting groups
406318|NCT00979901|B4|Baseline|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
406319|NCT00979901|B3|Baseline|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406320|NCT00979901|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406321|NCT00979901|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406322|NCT00979901|P4|Participant Flow|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
406323|NCT00979901|P3|Participant Flow|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406324|NCT00979901|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406325|NCT00979901|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406326|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406327|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406328|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406329|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406330|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406331|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406332|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406333|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406334|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406335|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406336|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406337|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406338|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406339|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406340|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406341|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406342|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406343|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406344|NCT00979901|E4|Reported Event|Montelukast 10 mg + Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
406345|NCT00979901|E3|Reported Event|Loratadine 10mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406346|NCT00979901|E2|Reported Event|Montelukast 10mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
406347|NCT00979901|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
406348|NCT00979875|B1|Baseline|Overall Study|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.~Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.~Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.~Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart."
406349|NCT00979875|P6|Participant Flow|Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone."
406373|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406374|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
407046|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
406350|NCT00979875|P5|Participant Flow|Aspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received and a single, SC injection of 95 U/mL Glulisine alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20."
406351|NCT00979875|P4|Participant Flow|Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, Lispro|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, subcutaneous (SC) injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone."
406352|NCT00979875|P3|Participant Flow|Lispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20."
406353|NCT00979875|P2|Participant Flow|Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, Aspart|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone."
406354|NCT00979875|P1|Participant Flow|Lispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20."
406355|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406356|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
406357|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406358|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
406359|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406360|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
406361|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406362|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
406363|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406364|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
406365|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406366|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
406367|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406368|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
406369|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406370|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
406371|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406372|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
406375|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406376|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
406377|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406378|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
406379|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406380|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
406381|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406382|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
406383|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406384|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
406385|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406386|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
406387|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406388|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
406389|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406390|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
406391|NCT00979875|E6|Reported Event|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406392|NCT00979875|E5|Reported Event|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
406393|NCT00979875|E4|Reported Event|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406394|NCT00979875|E3|Reported Event|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
406395|NCT00979875|E2|Reported Event|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
406396|NCT00979875|E1|Reported Event|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
406397|NCT00979654|B1|Baseline|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406398|NCT00979654|P1|Participant Flow|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406399|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406400|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406401|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406402|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406403|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406404|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406660|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
406405|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406406|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406407|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406408|NCT00979654|E1|Reported Event|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
406409|NCT00979628|B4|Baseline|Total|Total of all reporting groups
406410|NCT00979628|B3|Baseline|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime"
406411|NCT00979628|B2|Baseline|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed"
406412|NCT00979628|B1|Baseline|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 unitws/kg/day (plus corrective doses of glulisine as needed)"
406413|NCT00979628|P3|Participant Flow|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards."
406414|NCT00979628|P2|Participant Flow|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
406415|NCT00979628|P1|Participant Flow|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
406416|NCT00979628|O3|Outcome|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
406417|NCT00979628|O2|Outcome|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
406418|NCT00979628|O1|Outcome|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
406419|NCT00979628|E3|Reported Event|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
406420|NCT00979628|E2|Reported Event|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
406421|NCT00979628|E1|Reported Event|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
406422|NCT00979615|B3|Baseline|Total|Total of all reporting groups
406423|NCT00979615|B2|Baseline|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406424|NCT00979615|B1|Baseline|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406425|NCT00979615|P2|Participant Flow|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406426|NCT00979615|P1|Participant Flow|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406427|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406428|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406429|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406430|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406431|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406432|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406433|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406434|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406435|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406436|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406437|NCT00979615|E2|Reported Event|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
406438|NCT00979615|E1|Reported Event|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
406439|NCT00979602|B3|Baseline|Total|Total of all reporting groups
406440|NCT00979602|B2|Baseline|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406441|NCT00979602|B1|Baseline|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406661|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
406442|NCT00979602|P2|Participant Flow|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406443|NCT00979602|P1|Participant Flow|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406444|NCT00979602|O4|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406445|NCT00979602|O3|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406446|NCT00979602|O2|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406447|NCT00979602|O1|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406448|NCT00979602|O4|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406449|NCT00979602|O3|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406450|NCT00979602|O2|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406451|NCT00979602|O1|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406452|NCT00979602|O4|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406453|NCT00979602|O3|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406454|NCT00979602|O2|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406455|NCT00979602|O1|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406456|NCT00979602|O4|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406457|NCT00979602|O3|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406458|NCT00979602|O2|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406459|NCT00979602|O1|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406460|NCT00979602|O4|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406461|NCT00979602|O3|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406462|NCT00979602|O2|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406463|NCT00979602|O1|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406464|NCT00979602|O4|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406465|NCT00979602|O3|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406466|NCT00979602|O2|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406662|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
406467|NCT00979602|O1|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406468|NCT00979602|O4|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406469|NCT00979602|O3|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406470|NCT00979602|O2|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406471|NCT00979602|O1|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406472|NCT00979602|O2|Outcome|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406473|NCT00979602|O1|Outcome|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406474|NCT00979602|O2|Outcome|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406475|NCT00979602|O1|Outcome|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406476|NCT00979602|O2|Outcome|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406477|NCT00979602|O1|Outcome|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406478|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406479|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406480|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406481|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406482|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406483|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406484|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406485|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406486|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406487|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406488|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406489|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406490|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406663|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
406491|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406492|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406493|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406494|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406495|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406496|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406497|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406498|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406499|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406500|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406501|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406502|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406503|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406504|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406505|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406506|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406507|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406508|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406509|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406510|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406511|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406512|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406513|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406514|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406515|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406516|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406517|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406518|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406519|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406520|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406521|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406522|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406523|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406524|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406525|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406526|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406527|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406528|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406529|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406530|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406531|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406532|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406533|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406534|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406535|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406536|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406537|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406538|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406539|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406540|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406541|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406542|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406543|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406544|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406545|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406546|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406547|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406548|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406549|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406550|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406551|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406552|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406553|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406554|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406555|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406556|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406557|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406558|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406559|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406560|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406561|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406562|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406563|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406564|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406565|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406566|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406567|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406568|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406569|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406570|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406571|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406572|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406573|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406574|NCT00979602|O2|Outcome|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406575|NCT00979602|O1|Outcome|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406576|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406577|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406578|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406579|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406580|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406581|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406582|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406583|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406584|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406585|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406586|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406587|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406588|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406589|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406590|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406591|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406592|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406593|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406664|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
406594|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406595|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406596|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406597|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406598|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406599|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406600|NCT00979602|O8|Outcome|GSK2340273A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406601|NCT00979602|O7|Outcome|GSK2340273A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406602|NCT00979602|O6|Outcome|GSK2340274A (>64 y) Group|Healthy male or female subjects older than 64 years of age (>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406603|NCT00979602|O5|Outcome|GSK2340274A (18-64 y) Group|Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406604|NCT00979602|O4|Outcome|GSK2340273A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406605|NCT00979602|O3|Outcome|GSK2340273A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406606|NCT00979602|O2|Outcome|GSK2340274A (>60 y) Group|Healthy male or female subjects older than 60 years of age (>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406607|NCT00979602|O1|Outcome|GSK2340274A (18-60 y) Group|Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406608|NCT00979602|E2|Reported Event|GSK2340273A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406609|NCT00979602|E1|Reported Event|GSK2340274A Group|Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
406610|NCT00979576|B4|Baseline|Total|Total of all reporting groups
406611|NCT00979576|B3|Baseline|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406612|NCT00979576|B2|Baseline|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406613|NCT00979576|B1|Baseline|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406614|NCT00979576|P3|Participant Flow|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406665|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
406666|NCT00979459|E2|Reported Event|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
406615|NCT00979576|P2|Participant Flow|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406616|NCT00979576|P1|Participant Flow|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406617|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
406618|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
406619|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406620|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406621|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406622|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406623|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406624|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406625|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406626|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406627|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406628|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406629|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406630|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406631|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406632|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406633|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406634|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406635|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406636|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406637|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406638|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406639|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406640|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406667|NCT00979459|E1|Reported Event|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
406668|NCT00979420|B5|Baseline|Total|Total of all reporting groups
406669|NCT00979420|B4|Baseline|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406641|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406642|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406643|NCT00979576|E3|Reported Event|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406644|NCT00979576|E2|Reported Event|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
406645|NCT00979576|E1|Reported Event|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
406646|NCT00979550|B3|Baseline|Total|Total of all reporting groups
406647|NCT00979550|B2|Baseline|Non-medicated Petroleum Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~non-medicated petroleum cream: .5 oz cream nightly to the affected area"
406648|NCT00979550|B1|Baseline|Aldara Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~Imiquimod (Aldara): .5 oz cream nightly to the affected area"
406649|NCT00979550|P2|Participant Flow|Non-medicated Petroleum Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~non-medicated petroleum cream: .5 oz cream nightly to the affected area"
406650|NCT00979550|P1|Participant Flow|Aldara Cream|"The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.~Imiquimod (Aldara): .5 oz cream nightly to the affected area"
406651|NCT00979550|O2|Outcome|Non-medicated Petroleum Cream|Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
406652|NCT00979550|O1|Outcome|Aldara Cream|Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
406653|NCT00979550|E2|Reported Event|Non-medicated Petroleum Cream|Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
406654|NCT00979550|E1|Reported Event|Aldara Cream|Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
406655|NCT00979459|B1|Baseline|All Participants|Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC
406656|NCT00979459|P2|Participant Flow|MK-1006 FCT, Then MK-1006 DFC|Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period.
406657|NCT00979459|P1|Participant Flow|MK-1006 DFC, Then MK-1006 FCT|Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period.
406658|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
406659|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
406670|NCT00979420|B3|Baseline|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406671|NCT00979420|B2|Baseline|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406672|NCT00979420|B1|Baseline|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406673|NCT00979420|P4|Participant Flow|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406674|NCT00979420|P3|Participant Flow|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406675|NCT00979420|P2|Participant Flow|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
406676|NCT00979420|P1|Participant Flow|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406677|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406678|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406679|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406680|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406681|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406682|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406683|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406684|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406685|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406686|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406687|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406688|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406689|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406690|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406691|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406692|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406693|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406694|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406695|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406696|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406697|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406698|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406699|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406700|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406701|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406702|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406703|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406704|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406705|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406706|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406707|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406708|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406709|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
419191|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
406710|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406711|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406712|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406713|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406714|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406715|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406716|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406717|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406718|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406719|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406720|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
406721|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406722|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406723|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406724|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406725|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406726|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406727|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406728|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406729|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406730|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406731|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406732|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406733|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406734|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406735|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406736|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406737|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406738|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406739|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406740|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
406741|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
406742|NCT00979420|E1|Reported Event|Viramune|
406743|NCT00979303|B3|Baseline|Total|Total of all reporting groups
406744|NCT00979303|B2|Baseline|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
406745|NCT00979303|B1|Baseline|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
406746|NCT00979303|P2|Participant Flow|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
406747|NCT00979303|P1|Participant Flow|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
406748|NCT00979303|O2|Outcome|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
406750|NCT00979303|O2|Outcome|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
406751|NCT00979303|O1|Outcome|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
406752|NCT00979303|E2|Reported Event|Study Group|"Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.~Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure."
406753|NCT00979303|E1|Reported Event|Control Group|Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
406754|NCT00979212|B3|Baseline|Total|Total of all reporting groups
406755|NCT00979212|B2|Baseline|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406756|NCT00979212|B1|Baseline|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406757|NCT00979212|P2|Participant Flow|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406758|NCT00979212|P1|Participant Flow|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406759|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406760|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406761|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406762|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406763|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406764|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406765|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406766|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406767|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406768|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406769|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406770|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406771|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406772|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406773|NCT00979212|E2|Reported Event|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406774|NCT00979212|E1|Reported Event|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
406775|NCT00979199|B1|Baseline|CTCA and PET or SPECT and ECHO or MRI|
406776|NCT00979199|P1|Participant Flow|CTCA and PET or SPECT and ECHO or MRI|
406777|NCT00979199|O1|Outcome|Non Invasive Cardiac Imaging|All patients are submitted to non invasive cardiac imaging. 'Anatomical' information provided by CTA is obtained in every patient together with the 'functional' information provided by stress radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by stress MRI or ECHO imaging to assess myocardial contraction. All patients with at least one positive functional test undergo invasive coronary angiography to obtain the final diagnosis of IHD (Outcome measurement).
406778|NCT00979199|E1|Reported Event|Non Invasive Cardiac Imaging|
406779|NCT00979121|B3|Baseline|Total|Total of all reporting groups
406780|NCT00979121|B2|Baseline|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
406781|NCT00979121|B1|Baseline|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
406782|NCT00979121|P2|Participant Flow|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
406783|NCT00979121|P1|Participant Flow|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
406784|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
406785|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin:Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
406786|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
406787|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
406788|NCT00979121|O2|Outcome|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
406789|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
406790|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
406791|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Patients received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
406792|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital."
406793|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
406794|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
406795|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
406796|NCT00979121|E2|Reported Event|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
406797|NCT00979121|E1|Reported Event|Rosuvastatin|"Half of the subjects were randomized to the active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
406798|NCT00979069|B3|Baseline|Total|Total of all reporting groups
406799|NCT00979069|B2|Baseline|Control Group|No contact control
406800|NCT00979069|B1|Baseline|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
406801|NCT00979069|P2|Participant Flow|Control Group|No contact control
406802|NCT00979069|P1|Participant Flow|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
406803|NCT00979069|O2|Outcome|Control Group|No contact control
406804|NCT00979069|O1|Outcome|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
406805|NCT00979069|E2|Reported Event|Control Group|No contact control
406806|NCT00979069|E1|Reported Event|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
406807|NCT00979017|B1|Baseline|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406808|NCT00979017|P1|Participant Flow|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406889|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
407047|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
407048|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
406809|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406810|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406811|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406812|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406813|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406814|NCT00979017|E1|Reported Event|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
406815|NCT00978757|B3|Baseline|Total|Total of all reporting groups
406816|NCT00978757|B2|Baseline|Placebo|Placebo: saline solution
406817|NCT00978757|B1|Baseline|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
406818|NCT00978757|P2|Participant Flow|Placebo|Placebo: saline solution
406819|NCT00978757|P1|Participant Flow|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
406820|NCT00978757|O2|Outcome|Placebo|Placebo: saline solution
406821|NCT00978757|O1|Outcome|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
406822|NCT00978757|E2|Reported Event|Placebo|Placebo: saline solution
406823|NCT00978757|E1|Reported Event|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
406824|NCT00978731|B5|Baseline|Total|Total of all reporting groups
406836|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406825|NCT00978731|B4|Baseline|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406826|NCT00978731|B3|Baseline|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406827|NCT00978731|B2|Baseline|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406828|NCT00978731|B1|Baseline|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406829|NCT00978731|P4|Participant Flow|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406830|NCT00978731|P3|Participant Flow|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406831|NCT00978731|P2|Participant Flow|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406832|NCT00978731|P1|Participant Flow|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406833|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
406834|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
406835|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406888|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
407003|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406837|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406838|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406839|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406840|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406841|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406842|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406843|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406844|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406845|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406846|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
419192|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
406847|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406848|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406849|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406850|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406851|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406852|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406853|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406854|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406855|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406856|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
419193|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
406857|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406858|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406859|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406860|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406861|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406862|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406863|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406864|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406865|NCT00978731|E4|Reported Event|Participants With Myeloid Blast Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406866|NCT00978731|E3|Reported Event|Participants With CML; BID Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
407034|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
406867|NCT00978731|E2|Reported Event|Participants With Chronic Myelogenous Leukemia(CML);QD Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules: 5 days, on 2 days off; 6 days on, 1 day off; or continuous daily dosing. Participants were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to twice daily (BID) dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406868|NCT00978731|E1|Reported Event|Participants With Accelerated Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
406869|NCT00978627|B3|Baseline|Total|Total of all reporting groups
406870|NCT00978627|B2|Baseline|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406871|NCT00978627|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406872|NCT00978627|P2|Participant Flow|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406873|NCT00978627|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406874|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406875|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406876|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406877|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406878|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406879|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406880|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406881|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406882|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406883|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406884|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406885|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406886|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406887|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
407035|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
406890|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406891|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406892|NCT00978627|E2|Reported Event|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406893|NCT00978627|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
406894|NCT00978562|B1|Baseline|Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium)|"Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI~Ferumoxytol Non-Stoichiometric Magnetite: Given IV~Gadolinium: Given IV"
406895|NCT00978562|P1|Participant Flow|Ferumoxytol Dynamic Susceptibility (DSC) Weighted MRI and Gado|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
406896|NCT00978562|O1|Outcome|Gadolinium DCE|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
406897|NCT00978562|O1|Outcome|Ferumoxytol DSC MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
406898|NCT00978562|E1|Reported Event|Ferumoxytol DSC and Gad DCE MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
406899|NCT00978445|B1|Baseline|All Participants|all participants recieved all interventions during study
406900|NCT00978445|P2|Participant Flow|Standard/Home|all participants recieved home and standard protocol, in this ARM the standard protocol was a in clinic INR and interaction with a care giver, then the Home protocol was as described.
406901|NCT00978445|P1|Participant Flow|Home/Standard|all participants recieved home and standard protocol, in this ARM the home protocol was a virtual INR and communication using a remote communication device called vMetrics.
406902|NCT00978445|O2|Outcome|All Participants - Standard Protocol|all participants recieved all interventions during study
406903|NCT00978445|O1|Outcome|All Participants-home Protocol|all participants recieved all interventions during study
406904|NCT00978445|O2|Outcome|All Particpants - Standard Protocol|First and second group with vMetrics
406905|NCT00978445|O1|Outcome|All Participants-Home Protocol|all participants recieved all interventions during study
406906|NCT00978445|E1|Reported Event|All Participants|all participants recieved all interventions during study
406907|NCT00978432|B4|Baseline|Total|Total of all reporting groups
406908|NCT00978432|B3|Baseline|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
406909|NCT00978432|B2|Baseline|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406910|NCT00978432|B1|Baseline|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406911|NCT00978432|P3|Participant Flow|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
407036|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
407037|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
406912|NCT00978432|P2|Participant Flow|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406913|NCT00978432|P1|Participant Flow|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406914|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
406915|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406916|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406917|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
406918|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406919|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406920|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
406921|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
407038|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
407039|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
406922|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406923|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
406924|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406925|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406926|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
406927|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406928|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406929|NCT00978432|E3|Reported Event|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
406930|NCT00978432|E2|Reported Event|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
406931|NCT00978432|E1|Reported Event|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
407040|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
407041|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
406932|NCT00978380|B1|Baseline|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
406933|NCT00978380|P1|Participant Flow|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
406934|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
406935|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
406936|NCT00978380|E2|Reported Event|rFXIII Avecia|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Avecia drug.
406937|NCT00978380|E1|Reported Event|rFXIII Novo Nordisk|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Novo Nordisk drug.
406938|NCT00978341|B1|Baseline|All Subjects|Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning; and Placebo: Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406939|NCT00978341|P2|Participant Flow|Placebo First Then Pregabalin|First Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. Second Intervention Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406940|NCT00978341|P1|Participant Flow|Pregabalin First Then Placebo|First Intervention Pregabalin Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. Second Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406941|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406942|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406943|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406944|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406945|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406946|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406947|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406948|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406949|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406950|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406951|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406952|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406953|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning
406954|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406955|NCT00978341|E2|Reported Event|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
406956|NCT00978341|E1|Reported Event|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
406957|NCT00978120|B5|Baseline|Total|Total of all reporting groups
406958|NCT00978120|B4|Baseline|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406959|NCT00978120|B3|Baseline|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406960|NCT00978120|B2|Baseline|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
406961|NCT00978120|B1|Baseline|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406962|NCT00978120|P4|Participant Flow|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406963|NCT00978120|P3|Participant Flow|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406964|NCT00978120|P2|Participant Flow|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
406965|NCT00978120|P1|Participant Flow|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406966|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406967|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406968|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406969|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406970|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406971|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406972|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406973|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406974|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406975|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406976|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406977|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406978|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406979|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406980|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406981|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406982|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406983|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406984|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406985|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406986|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406987|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406988|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406989|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406990|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406991|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406992|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
406993|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406994|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406995|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406996|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
406997|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
406998|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
406999|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407000|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
407001|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407002|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
407004|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
407005|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407006|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
407007|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407008|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
407009|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407010|NCT00978120|E4|Reported Event|Severe Asthma, High Dose Vaccine (30mcg)|Participants with severe asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407011|NCT00978120|E3|Reported Event|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407012|NCT00978120|E2|Reported Event|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild/moderate asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407013|NCT00978120|E1|Reported Event|Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)|Participants with mild/moderate asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
407014|NCT00978042|B3|Baseline|Total|Total of all reporting groups
407015|NCT00978042|B2|Baseline|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
407016|NCT00978042|B1|Baseline|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
407017|NCT00978042|P2|Participant Flow|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
407018|NCT00978042|P1|Participant Flow|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
407019|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
407020|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
407021|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
407022|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
407023|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
407024|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
407025|NCT00978042|E2|Reported Event|All Treated Participants_ AEs After Repeat Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
407026|NCT00978042|E1|Reported Event|All Treated Participants_ AEs Initial Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment.
407027|NCT00978029|B4|Baseline|Total|Total of all reporting groups
407028|NCT00978029|B3|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
407029|NCT00978029|B2|Baseline|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
407030|NCT00978029|B1|Baseline|Placebo|Matching placebo tablet sublingual, once daily
407031|NCT00978029|P3|Participant Flow|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
407032|NCT00978029|P2|Participant Flow|SCH 39641 6 Amb a 1-U|6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily
407033|NCT00978029|P1|Participant Flow|Placebo|Matching placebo tablet sublingual, once daily
407049|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
407050|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
407051|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
407052|NCT00978029|E3|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
407053|NCT00978029|E2|Reported Event|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
407054|NCT00978029|E1|Reported Event|Placebo|Matching placebo tablet sublingual, once daily
407055|NCT00977938|B5|Baseline|Total|Total of all reporting groups
407056|NCT00977938|B4|Baseline|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407057|NCT00977938|B3|Baseline|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407058|NCT00977938|B2|Baseline|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407059|NCT00977938|B1|Baseline|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407060|NCT00977938|P4|Participant Flow|BMS 12-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
407061|NCT00977938|P3|Participant Flow|BMS 30-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
407062|NCT00977938|P2|Participant Flow|DES 12-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
407063|NCT00977938|P1|Participant Flow|DES 30-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
407064|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407065|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407066|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407067|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407068|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407069|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407070|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407071|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407072|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407073|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407074|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407075|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407076|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407077|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407078|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407079|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407080|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407081|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407082|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
407183|NCT00977574|E2|Reported Event|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
419194|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
407083|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
407084|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
407085|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
407086|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407087|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407088|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407089|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407090|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
407091|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
407092|NCT00977938|E4|Reported Event|HCRI DAPT - BMS 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
407093|NCT00977938|E3|Reported Event|HCRI DAPT - BMS 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
407094|NCT00977938|E2|Reported Event|HCRI DAPT - DES 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
407095|NCT00977938|E1|Reported Event|HCRI DAPT - DES 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
407096|NCT00977808|B1|Baseline|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
407097|NCT00977808|P1|Participant Flow|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
407098|NCT00977808|O2|Outcome|Control: Open-Loop|Insulin dosing was performed by the patient (using their normal routine and personal insulin pump) under a physician's supervision.
407099|NCT00977808|O1|Outcome|Experimental: Closed-Loop Model Predictive Control (MPC)|Insulin dosing was performed by a model-predictive control (MPC) algorithm.
407159|NCT00977613|B1|Baseline|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
407100|NCT00977808|E1|Reported Event|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
407101|NCT00977769|B4|Baseline|Total|Total of all reporting groups
407102|NCT00977769|B3|Baseline|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
407103|NCT00977769|B2|Baseline|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
407104|NCT00977769|B1|Baseline|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
407105|NCT00977769|P3|Participant Flow|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
407106|NCT00977769|P2|Participant Flow|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
407107|NCT00977769|P1|Participant Flow|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
407108|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
407109|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
407110|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
407111|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
407112|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
407113|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
407114|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
407115|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
407116|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
407117|NCT00977769|E3|Reported Event|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
407118|NCT00977769|E2|Reported Event|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
407119|NCT00977769|E1|Reported Event|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
407120|NCT00977704|B1|Baseline|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
407121|NCT00977704|P1|Participant Flow|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
407122|NCT00977704|O1|Outcome|Restylane and Perlane|Single arm safety study of subjects receiving Restylane and Perlane.
407123|NCT00977704|E1|Reported Event|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
407124|NCT00977665|B3|Baseline|Total|Total of all reporting groups
407125|NCT00977665|B2|Baseline|Placebo|placebo tablet for up to 48 weeks.
407126|NCT00977665|B1|Baseline|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407127|NCT00977665|P2|Participant Flow|Placebo|placebo tablet for up to 48 weeks.
407128|NCT00977665|P1|Participant Flow|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407129|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407130|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407131|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407132|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407133|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407134|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407135|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407136|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407137|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407138|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407139|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407140|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407141|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407142|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407143|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407144|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407145|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407146|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407147|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407148|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407149|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407150|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407151|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407152|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407153|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407154|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407155|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
407156|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
407157|NCT00977665|E2|Reported Event|Rasagiline Mesylate|Rasagiline tablet, 1 mg/day for up to 48 weeks.
407158|NCT00977665|E1|Reported Event|Placebo|Placebo tablet for up to 48 weeks.
407182|NCT00977574|E3|Reported Event|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407160|NCT00977613|P1|Participant Flow|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
407161|NCT00977613|O1|Outcome|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
407162|NCT00977613|E1|Reported Event|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
407163|NCT00977574|B4|Baseline|Total|Total of all reporting groups
407164|NCT00977574|B3|Baseline|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407165|NCT00977574|B2|Baseline|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
407166|NCT00977574|B1|Baseline|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407167|NCT00977574|P3|Participant Flow|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407168|NCT00977574|P2|Participant Flow|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
407169|NCT00977574|P1|Participant Flow|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407170|NCT00977574|O3|Outcome|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407171|NCT00977574|O2|Outcome|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
407172|NCT00977574|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407173|NCT00977574|O3|Outcome|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407174|NCT00977574|O2|Outcome|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
407175|NCT00977574|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407176|NCT00977574|O3|Outcome|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407177|NCT00977574|O2|Outcome|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
407178|NCT00977574|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407179|NCT00977574|O3|Outcome|Arm III (Ixabepilone, Carboplatin, Bevacizumab)|Ixabepilone 30 mg/m2 IV over 1 hour day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407180|NCT00977574|O2|Outcome|Arm II (Paclitaxel, Carboplatin, Temsirolimus)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 5 IV day 1 Temsirolimus 25 mg IV days 1 and 8 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen – Temsirolimus 25 mg IV weekly days 1, 8 and 15 (one cycle = 21 days)
407181|NCT00977574|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407184|NCT00977574|E1|Reported Event|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|Paclitaxel 175 mg/m2 IV over 3 hours day 1 Carboplatin AUC = 6 IV day 1 Bevacizumab 15mg/kg IV day 1 (starting with cycle 2 for those patients who are entering post surgery) Maintenance regimen - Bevacizumab 15mg/kg IV every 21 days
407185|NCT00977561|B3|Baseline|Total|Total of all reporting groups
407186|NCT00977561|B2|Baseline|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407187|NCT00977561|B1|Baseline|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Day 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407188|NCT00977561|P2|Participant Flow|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407189|NCT00977561|P1|Participant Flow|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliter*minute (mg/mL*min) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407190|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407191|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407192|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407193|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407194|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407195|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407196|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407197|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407198|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407199|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407452|NCT00977080|P1|Participant Flow|IV Paricalcitol in the IV Stratum|IV stratum
407453|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
407200|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Participants who received figitumumab, whether figitumumab (20 mg/kg, IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles) was given in combination with cisplatin (75 mg/m^2 IV over 1 hour on Day 1 of each cycle) or carboplatin (AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 of each cycle) followed by etoposide (100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle) from the beginning or figitumumab was given as a single agent after documented disease progression with cisplatin (or carboplatin) and etoposide. When given as a single agent, figitumumab was administered as IV infusion on Days 1 and 2 of the initial cycle and on Day 1 of subsequent cycles, up to 17 cycles in the absence of further disease progression or intolerable toxicity. Each cycle was 21 days cycle.
407201|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407202|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407203|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407204|NCT00977561|O1|Outcome|Figitumumab+ Cisplatin (or Carboplatin) + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407205|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407206|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407207|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407208|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407209|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407210|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407211|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407212|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407213|NCT00977561|E2|Reported Event|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
419195|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
407214|NCT00977561|E1|Reported Event|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
407215|NCT00977548|B1|Baseline|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
407216|NCT00977548|P1|Participant Flow|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
407217|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
407218|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
407219|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
407220|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
407221|NCT00977548|E1|Reported Event|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
407222|NCT00977470|B3|Baseline|Total|Total of all reporting groups
407223|NCT00977470|B2|Baseline|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407224|NCT00977470|B1|Baseline|Erlotinib|Erlotinib: 150 mg taken orally once daily
407225|NCT00977470|P2|Participant Flow|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407226|NCT00977470|P1|Participant Flow|Erlotinib|Erlotinib: 150 mg taken orally once daily
407227|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407228|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
407229|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407230|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
407231|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407232|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
407233|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407234|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
407235|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407236|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
407237|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407238|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
407239|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407240|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
407241|NCT00977470|E2|Reported Event|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
407242|NCT00977470|E1|Reported Event|Erlotinib|Erlotinib: 150 mg taken orally once daily
407243|NCT00977379|B3|Baseline|Total|Total of all reporting groups
407244|NCT00977379|B2|Baseline|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407245|NCT00977379|B1|Baseline|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407246|NCT00977379|P2|Participant Flow|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407247|NCT00977379|P1|Participant Flow|WBRT Followed by Standard of Care|Participants received 3000 centi-Gray (cGy) whole brain radiation therapy (WBRT) in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (central nervous system [CNS] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407454|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
407248|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407249|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407250|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407251|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407252|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407253|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407254|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407255|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407256|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407257|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407258|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407259|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407260|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407455|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
407456|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
407261|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407262|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407263|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407264|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407265|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407266|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407267|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407268|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407269|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407270|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407271|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407272|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407273|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407457|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
407458|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
407274|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407275|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407276|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407277|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407278|NCT00977379|E2|Reported Event|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
407279|NCT00977379|E1|Reported Event|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
407280|NCT00977314|B3|Baseline|Total|Total of all reporting groups
407281|NCT00977314|B2|Baseline|Pilot Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
407282|NCT00977314|B1|Baseline|Analyzed Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
407283|NCT00977314|P2|Participant Flow|Pilot Group|"Per the protocol, the first five (5) subjects were enrolled in the pilot group of the study to work out the process flow and training of the centers and participants."
407284|NCT00977314|P1|Participant Flow|Analyzed Group|30 subjects were enrolled in the analyzed group with only 24 subjects expected to complete it. With an approximated 20% subject dropout rate anticipated. The total number of subjects that completed the study was 28 of 30 enrolled in the analyzed group.
407285|NCT00977314|O1|Outcome|Global Benefit|The Global Benefit APHAB at 30 days is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 30 days of therapy. The APHAB questionnaire produces an overall Global score (GBL). The benefit provided by the SoundBite System can be determined by comparing changes in the mean APHAB score. The larger the APHAB benefit score the great the benefit. A negative APHAB score represents therapy resulting in a worse outcome than no therapy.
407286|NCT00977314|O1|Outcome|HINT (dB) Advantage|"Effectiveness was defined as “Change from Baseline” analysis of the Hearing in Noise Test (HINT), Noise on Better Side Scores between without the BCD at day one and with the BCD at day thirty.Effectiveness was determined as an improvement in the HINT score for which the device was designed, that is, the condition where noise originates on the normal hearing side and speech is presented from the front. .~An improvement in HINT score is indicated as a negative (-) dB value change. A change in the HINT score of -1 dB represents an improvement of 10% in speech intelligibility in that particular test condition. A 10% improvement in speech intelligibility in this very adverse listening condition is a noticeable benefit to the SSD subject. This amount of improvement is even more of a benefit in more realistic, less adverse listening conditions."
407287|NCT00977314|O1|Outcome|Medical, Dental, Audiological Safety 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:~Comprehensive Medical evaluation at Enrollment and at Termination~Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed~Comprehensive Audiological evaluation at Enrollment and Termination.~No Medical, Dental or Audiological adverse events."
407288|NCT00977314|E1|Reported Event|Incidence of Device- and Procedure-related Adverse Events|Incidence of device- and procedure-related adverse events at 30 days
407289|NCT00977197|B3|Baseline|Total|Total of all reporting groups
407290|NCT00977197|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407459|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
407460|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
407291|NCT00977197|B1|Baseline|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407292|NCT00977197|P2|Participant Flow|Placebo|"Subjects randomized to this arm will receive placebo matching the study drug.~Placebo: A matching placebo will be administered twice a day"
407293|NCT00977197|P1|Participant Flow|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.~Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407294|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407295|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407296|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407297|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407298|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407299|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407300|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407301|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407302|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407303|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407304|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407305|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407306|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407307|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407308|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407309|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407310|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407311|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407312|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407461|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
407462|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
407313|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407314|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407315|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407316|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407317|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407318|NCT00977197|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
407319|NCT00977197|E1|Reported Event|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
407320|NCT00977184|B3|Baseline|Total|Total of all reporting groups
407321|NCT00977184|B2|Baseline|Sham rTMS|Subjects receiving sham rTMS.
407322|NCT00977184|B1|Baseline|Real rTMS|Subjects receiving real rTMS
407323|NCT00977184|P2|Participant Flow|Sham rTMS|Subjects receiving sham rTMS.
407324|NCT00977184|P1|Participant Flow|Real rTMS|Subjects receiving real rTMS
407325|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
407326|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
407327|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
407328|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
407329|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
407330|NCT00977184|O3|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
407331|NCT00977184|O2|Outcome|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
407332|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
407333|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
407334|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
407335|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
407336|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
407337|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
407338|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
407339|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
407340|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
407341|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
407342|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
407343|NCT00977184|O2|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
407344|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
407345|NCT00977184|E4|Reported Event|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
407346|NCT00977184|E3|Reported Event|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
407347|NCT00977184|E2|Reported Event|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
407348|NCT00977184|E1|Reported Event|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
407349|NCT00977171|B1|Baseline|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
407350|NCT00977171|P1|Participant Flow|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
407351|NCT00977171|O1|Outcome|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
407352|NCT00977171|E1|Reported Event|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
407353|NCT00977106|B3|Baseline|Total|Total of all reporting groups
407354|NCT00977106|B2|Baseline|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407355|NCT00977106|B1|Baseline|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407356|NCT00977106|P2|Participant Flow|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407463|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
407357|NCT00977106|P1|Participant Flow|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) intravenously (IV) during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 milligrams per kilogram (mg/kg; 800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407358|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407359|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407360|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407361|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407362|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407363|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407364|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407365|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407366|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407367|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407368|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407369|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407370|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407371|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407372|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407373|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407374|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407375|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407376|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407377|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407378|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407464|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
407465|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
407379|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407380|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407381|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407382|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407383|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407384|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407385|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407386|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407387|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407388|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407389|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407390|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407391|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407392|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407393|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407394|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407395|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407396|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407397|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407398|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407399|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407466|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
407467|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
407468|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
407469|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
407400|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407401|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407402|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407403|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407404|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407405|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407406|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407407|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407408|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407409|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407410|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407411|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407412|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407413|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407414|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407415|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407416|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407417|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407418|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407419|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407420|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407421|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407470|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
407471|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
407422|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407423|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407424|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407425|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407426|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407427|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407428|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407429|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407430|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407431|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407432|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407433|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407434|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407435|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407436|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407437|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407438|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407439|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407440|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407441|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407442|NCT00977106|E2|Reported Event|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
407443|NCT00977106|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
407444|NCT00977080|B5|Baseline|Total|Total of all reporting groups
407445|NCT00977080|B4|Baseline|Cinacalcet in the Oral Stratum|Oral stratum
407446|NCT00977080|B3|Baseline|Oral Paricalcitol in the Oral Stratum|Oral stratum
407447|NCT00977080|B2|Baseline|Cinacalcet in the IV Stratum|IV stratum
407448|NCT00977080|B1|Baseline|IV Paricalcitol in the IV Stratum|IV stratum
407449|NCT00977080|P4|Participant Flow|Cinacalcet in the Oral Stratum|Oral stratum
407450|NCT00977080|P3|Participant Flow|Oral Paricalcitol in the Oral Stratum|Oral stratum
407451|NCT00977080|P2|Participant Flow|Cinacalcet in the IV Stratum|IV stratum
407472|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
407474|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
407475|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
407476|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
407477|NCT00977080|E4|Reported Event|Cinacalcet in the Oral Stratum|Oral stratum
407478|NCT00977080|E3|Reported Event|Oral Paricalcitol in the Oral Stratum|Oral stratum
407479|NCT00977080|E2|Reported Event|Cinacalcet in the IV Stratum|IV stratum
407480|NCT00977080|E1|Reported Event|IV Paricalcitol in the IV Stratum|IV stratum
407481|NCT00976989|B4|Baseline|Total|Total of all reporting groups
407482|NCT00976989|B3|Baseline|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407483|NCT00976989|B2|Baseline|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407484|NCT00976989|B1|Baseline|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407485|NCT00976989|P3|Participant Flow|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407486|NCT00976989|P2|Participant Flow|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407487|NCT00976989|P1|Participant Flow|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407488|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407489|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407490|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407491|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407492|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407493|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407494|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407495|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407496|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407497|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407498|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407499|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407500|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407501|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407502|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407503|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407504|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407505|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407506|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407507|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407508|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407509|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407510|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407511|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407512|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407513|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407514|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407515|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407516|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407517|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407518|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407519|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407520|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407521|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407522|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407523|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407524|NCT00976989|E3|Reported Event|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407525|NCT00976989|E2|Reported Event|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
407526|NCT00976989|E1|Reported Event|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
407527|NCT00976950|B1|Baseline|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
407528|NCT00976950|P1|Participant Flow|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
407529|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
407530|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
407531|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
407532|NCT00976950|E1|Reported Event|Aptivus and Ritonavir|ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
407533|NCT00976937|B3|Baseline|Total|Total of all reporting groups
407534|NCT00976937|B2|Baseline|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
407535|NCT00976937|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 mg capsule orally QD up to Week 24.
407536|NCT00976937|P2|Participant Flow|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
407537|NCT00976937|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
407538|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407539|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407540|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407541|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407542|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407543|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407544|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407545|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407546|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407547|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407548|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407549|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407550|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407551|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407552|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407553|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407554|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407555|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407556|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407557|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407558|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407559|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407560|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407561|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407562|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407563|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407564|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407565|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407566|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407567|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407568|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407569|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407570|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407571|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407572|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407573|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407574|NCT00976937|E2|Reported Event|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
407575|NCT00976937|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
407576|NCT00976911|B3|Baseline|Total|Total of all reporting groups
407577|NCT00976911|B2|Baseline|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407578|NCT00976911|B1|Baseline|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407579|NCT00976911|P2|Participant Flow|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407580|NCT00976911|P1|Participant Flow|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407581|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407582|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407583|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407953|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
408039|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407584|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407585|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407586|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407587|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407588|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407589|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407590|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407591|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407592|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407593|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407594|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407595|NCT00976911|E2|Reported Event|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
407596|NCT00976911|E1|Reported Event|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
407597|NCT00976898|B1|Baseline|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
407598|NCT00976898|P1|Participant Flow|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
407599|NCT00976898|O1|Outcome|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
407600|NCT00976898|O1|Outcome|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
407601|NCT00976898|O1|Outcome|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
407602|NCT00976898|O1|Outcome|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
407603|NCT00976898|E1|Reported Event|Proton Beam Irradiation|"This is a single arm study. All study participants will receive proton radiation therapy.~Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks"
407604|NCT00976820|B5|Baseline|Total|Total of all reporting groups
407605|NCT00976820|B4|Baseline|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407606|NCT00976820|B3|Baseline|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407607|NCT00976820|B2|Baseline|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407608|NCT00976820|B1|Baseline|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407609|NCT00976820|P4|Participant Flow|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407610|NCT00976820|P3|Participant Flow|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407954|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
408040|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407611|NCT00976820|P2|Participant Flow|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407612|NCT00976820|P1|Participant Flow|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407613|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407614|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407615|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407616|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407617|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407618|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407619|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407620|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407621|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407622|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407623|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407955|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
408322|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
407624|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407625|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407626|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407627|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407628|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407629|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407630|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407631|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407632|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407633|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407634|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407635|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407636|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407956|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
408142|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407637|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407638|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407639|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407640|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407641|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407642|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407643|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407644|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407645|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407646|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407647|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407648|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407649|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407957|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
408253|NCT00976521|B5|Baseline|Total|Total of all reporting groups
407650|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407651|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407652|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407653|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407654|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407655|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407656|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407657|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407658|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407659|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407660|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407661|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407662|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407958|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
408254|NCT00976521|B4|Baseline|No Local Infusion, no Aspiration|No local infusion of abciximab and no thrombus aspiration
407663|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407664|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407665|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407666|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407667|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407668|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407669|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407670|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407671|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407672|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407673|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407674|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407675|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407959|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
408255|NCT00976521|B3|Baseline|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
407676|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407677|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407678|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407679|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407680|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407681|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407682|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407683|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407684|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407685|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407686|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407687|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407688|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407960|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
408318|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
407689|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407690|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407691|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407692|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407693|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407694|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407695|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407696|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407697|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407698|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407699|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407700|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407701|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407961|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
408319|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
407702|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407703|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407704|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407705|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407706|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407707|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407708|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407709|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407710|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407711|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407712|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407713|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407714|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407962|NCT00976716|E1|Reported Event|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
407963|NCT00976703|B3|Baseline|Total|Total of all reporting groups
407715|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407716|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407717|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407718|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407719|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407720|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407721|NCT00976820|O4|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407722|NCT00976820|O3|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407723|NCT00976820|O2|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407724|NCT00976820|O1|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407725|NCT00976820|O8|Outcome|GSK2340273A/F2 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407726|NCT00976820|O7|Outcome|GSK2340273A/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407727|NCT00976820|O6|Outcome|GSK2340273A/F1 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408041|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408042|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407728|NCT00976820|O5|Outcome|GSK2340273A/F1 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407729|NCT00976820|O4|Outcome|Arepanrix/F2 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407730|NCT00976820|O3|Outcome|Arepanrix/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407731|NCT00976820|O2|Outcome|Arepanrix/F1 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407732|NCT00976820|O1|Outcome|Arepanrix/F1 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407733|NCT00976820|O4|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407734|NCT00976820|O3|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407735|NCT00976820|O2|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407736|NCT00976820|O1|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407737|NCT00976820|O4|Outcome|GSK2340273A/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407738|NCT00976820|O3|Outcome|GSK2340273A/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407739|NCT00976820|O2|Outcome|Arepanrix/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407740|NCT00976820|O1|Outcome|Arepanrix/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408043|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
419196|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
407741|NCT00976820|O4|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407742|NCT00976820|O3|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407743|NCT00976820|O2|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407744|NCT00976820|O1|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407745|NCT00976820|O4|Outcome|GSK2340273A/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407746|NCT00976820|O3|Outcome|GSK2340273A/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407747|NCT00976820|O2|Outcome|Arepanrix/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407748|NCT00976820|O1|Outcome|Arepanrix/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407749|NCT00976820|O13|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407750|NCT00976820|O12|Outcome|GSK2340273A/F2 3Y-6Y Group|Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407751|NCT00976820|O11|Outcome|GSK2340273A/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407752|NCT00976820|O10|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407753|NCT00976820|O9|Outcome|GSK2340273A/F1 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408044|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408320|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
407754|NCT00976820|O8|Outcome|GSK2340273A/F1 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407755|NCT00976820|O7|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407756|NCT00976820|O6|Outcome|Arepanrix/F2 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407757|NCT00976820|O5|Outcome|Arepanrix/F2 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407758|NCT00976820|O4|Outcome|Arepanrix/F1 Out Group|Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407759|NCT00976820|O3|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407760|NCT00976820|O2|Outcome|Arepanrix/F1 3Y-5Y Group|Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407761|NCT00976820|O1|Outcome|Arepanrix/F1 6M-35M Group|Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407762|NCT00976820|O9|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407763|NCT00976820|O8|Outcome|GSK2340273A/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407764|NCT00976820|O7|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407765|NCT00976820|O6|Outcome|GSK2340273A/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407766|NCT00976820|O5|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408045|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
419197|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
407767|NCT00976820|O4|Outcome|Arepanrix/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407768|NCT00976820|O3|Outcome|Arepanrix/F1 Out Group|Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407769|NCT00976820|O2|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407770|NCT00976820|O1|Outcome|Arepanrix/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407771|NCT00976820|O8|Outcome|GSK2340273A/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407772|NCT00976820|O7|Outcome|GSK2340273A/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407773|NCT00976820|O6|Outcome|GSK2340273A/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407774|NCT00976820|O5|Outcome|GSK2340273A/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407775|NCT00976820|O4|Outcome|Arepanrix/F2 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407776|NCT00976820|O3|Outcome|Arepanrix/F2 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407777|NCT00976820|O2|Outcome|Arepanrix/F1 6Y-9Y Group|Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407778|NCT00976820|O1|Outcome|Arepanrix/F1 6M-5Y Group|Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407779|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408046|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408321|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
407780|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407781|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407782|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407783|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407784|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407785|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407786|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407787|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407788|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407789|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407790|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407791|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407792|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407964|NCT00976703|B2|Baseline|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
407793|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407794|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407795|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407796|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407797|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407798|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407799|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407800|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407801|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407802|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407803|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407804|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407805|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408017|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408018|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407806|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407807|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407808|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407809|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407810|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407811|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407812|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407813|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407814|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407815|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407816|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407817|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407818|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408019|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408020|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407819|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407820|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407821|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407822|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407823|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407824|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407825|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407826|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407827|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407828|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407829|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407830|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407831|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408021|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408022|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407832|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407833|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407834|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407835|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407836|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407837|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407838|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407839|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407840|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407841|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407842|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407843|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407844|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408023|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408024|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407845|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407846|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407847|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407848|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407849|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407850|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407851|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407852|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407853|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407854|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407855|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407856|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407857|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408025|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408026|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407858|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407859|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407860|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407861|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407862|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407863|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407864|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407865|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407866|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407867|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407868|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407869|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407870|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408027|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408028|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407871|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407872|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407873|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407874|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407875|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407876|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407877|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407878|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407879|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407880|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407881|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407882|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407883|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408029|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408030|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407884|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407885|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407886|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407887|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407888|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407889|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407890|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407891|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407892|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407893|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407894|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407895|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407896|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408031|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408032|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407897|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407898|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407899|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407900|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407901|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407902|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407903|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407904|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407905|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407906|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407907|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407908|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407909|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408033|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408034|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407910|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407911|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407912|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407913|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407914|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407915|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407916|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407917|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407918|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407919|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407920|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407921|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407922|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408035|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408036|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407923|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407924|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407925|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407926|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407927|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407928|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407929|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407930|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407931|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407932|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407933|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407934|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407935|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
408037|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408038|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407936|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407937|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407938|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407939|NCT00976820|O4|Outcome|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407940|NCT00976820|O3|Outcome|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407941|NCT00976820|O2|Outcome|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407942|NCT00976820|O1|Outcome|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407943|NCT00976820|E4|Reported Event|GSK2340273A/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407944|NCT00976820|E3|Reported Event|GSK2340273A/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407945|NCT00976820|E2|Reported Event|Arepanrix/F2 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407946|NCT00976820|E1|Reported Event|Arepanrix/F1 Group|Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
407947|NCT00976716|B1|Baseline|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
407948|NCT00976716|P1|Participant Flow|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
407949|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
407950|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
407951|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
407952|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
407965|NCT00976703|B1|Baseline|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
407966|NCT00976703|P2|Participant Flow|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
407967|NCT00976703|P1|Participant Flow|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
407968|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
407969|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
407970|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
407971|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
407972|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
407973|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
407974|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
407975|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
407976|NCT00976703|E2|Reported Event|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
407977|NCT00976703|E1|Reported Event|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
407978|NCT00976677|B3|Baseline|Total|Total of all reporting groups
407979|NCT00976677|B2|Baseline|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
407980|NCT00976677|B1|Baseline|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
407981|NCT00976677|P2|Participant Flow|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
407982|NCT00976677|P1|Participant Flow|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
408094|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
407983|NCT00976677|O2|Outcome|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
407984|NCT00976677|O1|Outcome|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
407985|NCT00976677|E2|Reported Event|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
407986|NCT00976677|E1|Reported Event|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
407987|NCT00976664|B3|Baseline|Total|Total of all reporting groups
407988|NCT00976664|B2|Baseline|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
407989|NCT00976664|B1|Baseline|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
407990|NCT00976664|P2|Participant Flow|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
407991|NCT00976664|P1|Participant Flow|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
407992|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
407993|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
407994|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
407995|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
407996|NCT00976664|E2|Reported Event|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
407997|NCT00976664|E1|Reported Event|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
407998|NCT00976599|B3|Baseline|Total|Total of all reporting groups
407999|NCT00976599|B2|Baseline|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408000|NCT00976599|B1|Baseline|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408001|NCT00976599|P2|Participant Flow|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408002|NCT00976599|P1|Participant Flow|CP-690,550|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408003|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408004|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408005|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408006|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408007|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408008|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408009|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408010|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408011|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408012|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408013|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408014|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408015|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408016|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408047|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408048|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408049|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408050|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408051|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408052|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408053|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408054|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408055|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408056|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408057|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408058|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408059|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408060|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408061|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408062|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408063|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408064|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408065|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408066|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408067|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408068|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408069|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408070|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408071|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408072|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408073|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408074|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408075|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408076|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408077|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408078|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408079|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408080|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408081|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408082|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408083|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408084|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408085|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408086|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408087|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408088|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408089|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408090|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408091|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408092|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408093|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408095|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408096|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408097|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408098|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408099|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408100|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408101|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408102|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408103|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408104|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408105|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408106|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408107|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408108|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408109|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408110|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408111|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408112|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408113|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408114|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408115|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408116|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408117|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408118|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408119|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408120|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408121|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408122|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408123|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408124|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408125|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408126|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408127|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408128|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408129|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408130|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408131|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408132|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408133|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408134|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408135|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408136|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408137|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408138|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408139|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408140|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408141|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408143|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408144|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408145|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408146|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408147|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408148|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408149|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408150|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408151|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408152|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408153|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408154|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408155|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408156|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408157|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408158|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408159|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408160|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408161|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408162|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408163|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408164|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408165|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408166|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408167|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408168|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408169|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408170|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408171|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408172|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408173|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408174|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408175|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408176|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408177|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408178|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408179|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408180|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408181|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408182|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408183|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408184|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408185|NCT00976599|E2|Reported Event|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408186|NCT00976599|E1|Reported Event|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
408187|NCT00976573|B3|Baseline|Total|Total of all reporting groups
408188|NCT00976573|B2|Baseline|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
419198|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
408189|NCT00976573|B1|Baseline|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408190|NCT00976573|P2|Participant Flow|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408191|NCT00976573|P1|Participant Flow|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408192|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408193|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408194|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408195|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408196|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408197|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408198|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408199|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408200|NCT00976573|E2|Reported Event|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408201|NCT00976573|E1|Reported Event|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
408202|NCT00976560|B3|Baseline|Total|Total of all reporting groups
408203|NCT00976560|B2|Baseline|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408204|NCT00976560|B1|Baseline|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408205|NCT00976560|P2|Participant Flow|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408206|NCT00976560|P1|Participant Flow|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408207|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408208|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408209|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408210|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408211|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408212|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408213|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408214|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408215|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
419199|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
408216|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408217|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408218|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408219|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408220|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408221|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408222|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408223|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408224|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408225|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408226|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408227|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408228|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408229|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408230|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408231|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408232|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408233|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408234|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408235|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408236|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408237|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408238|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408239|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408240|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408241|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408242|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408243|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408244|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408245|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408246|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408247|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408248|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408249|NCT00976560|O2|Outcome|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408250|NCT00976560|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408251|NCT00976560|E2|Reported Event|GW856553 7.5 mg BID|Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408252|NCT00976560|E1|Reported Event|Placebo|Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
408256|NCT00976521|B2|Baseline|Local Infusion, no Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration
408257|NCT00976521|B1|Baseline|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
408258|NCT00976521|P4|Participant Flow|No Local Infusion, no Aspiration|"No local infusion of abciximab and no thrombus aspiration.~The lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care."
408259|NCT00976521|P3|Participant Flow|No Local Infusion, Thrombus Aspiration|"No local infusion of abciximab, thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed."
408260|NCT00976521|P2|Participant Flow|Local Infusion, no Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.~The initial device used to cross the lesion is a 1.0 mm or 1.5 mm diameter ClearWay™ RX Infusion Catheter (1.0 mm for complete occlusion).~If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
408261|NCT00976521|P1|Participant Flow|Local Infusion, Thrombus Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.~After withdrawing the aspiration catheter, the lesion is crossed with a 1.0 mm, 1.5 mm, or 2.0 mm diameter ClearWay™ RX Infusion Catheter (depending on the lumen diameter created by thrombus aspiration and the reference vessel diameter). If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
408262|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
408263|NCT00976521|O2|Outcome|No Aspiration|No aspiration includes subjects randomized to either the following two arms: abciximab infusion arm without aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion without aspiration, the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter. If randomized to no abciximab without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
408264|NCT00976521|O1|Outcome|Thrombus Aspiration|Thrombus aspiration includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or no abciximab infusion with aspiration. A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter. Multiple passes should be made with contrast injection after each pass until the operator appreciates that no further thrombus is being removed.
408265|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
408266|NCT00976521|O2|Outcome|No Infusion|No Infusion includes subjects randomized to either the following two arms: no abciximab infusion with aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion with aspiration, a 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until no further thrombus is being removed. If randomized to no abciximab infusion without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
408267|NCT00976521|O1|Outcome|Abciximab Infusion|Abciximab Infusion includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or abciximab infusion arm without aspiration. If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
408268|NCT00976521|E4|Reported Event|No Local Infusion, No Aspiration|No local infusion of abciximab and no thrombus aspiration.
408269|NCT00976521|E3|Reported Event|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
408270|NCT00976521|E2|Reported Event|Local Infusion, No Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
408271|NCT00976521|E1|Reported Event|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration
408272|NCT00976508|B3|Baseline|Total|Total of all reporting groups
408273|NCT00976508|B2|Baseline|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408274|NCT00976508|B1|Baseline|Figitumumab 20 mg/kg +Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408275|NCT00976508|P2|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408276|NCT00976508|P1|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408277|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408278|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408279|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408280|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408281|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408282|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408283|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408284|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408285|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408286|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408287|NCT00976508|O2|Outcome|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
408288|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408289|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408290|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408291|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408292|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408293|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408294|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408295|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408296|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408297|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408298|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408299|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408300|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408301|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408302|NCT00976508|O1|Outcome|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408303|NCT00976508|E2|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
408304|NCT00976508|E1|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
408305|NCT00976495|B4|Baseline|Total|Total of all reporting groups
408306|NCT00976495|B3|Baseline|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
408307|NCT00976495|B2|Baseline|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
408308|NCT00976495|B1|Baseline|Placebo|Tablet, oral, once daily for 12 weeks
408309|NCT00976495|P3|Participant Flow|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
408310|NCT00976495|P2|Participant Flow|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
408311|NCT00976495|P1|Participant Flow|Placebo|Tablet, oral, once daily for 12 weeks
408312|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
408313|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
408314|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
408315|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
408316|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
408317|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
408323|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
408324|NCT00976495|E3|Reported Event|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
408325|NCT00976495|E2|Reported Event|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
408326|NCT00976495|E1|Reported Event|Placebo|Tablet, oral, once daily for 12 weeks
408327|NCT00976482|B1|Baseline|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
408328|NCT00976482|P1|Participant Flow|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
408329|NCT00976482|O1|Outcome|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
408330|NCT00976482|E1|Reported Event|Pacemaker|implanted Patients
408331|NCT00976456|B3|Baseline|Total|Total of all reporting groups
408332|NCT00976456|B2|Baseline|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
408333|NCT00976456|B1|Baseline|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
408334|NCT00976456|P2|Participant Flow|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
408335|NCT00976456|P1|Participant Flow|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
408336|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
408337|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
408338|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
408339|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
408340|NCT00976456|E2|Reported Event|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
408341|NCT00976456|E1|Reported Event|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
408342|NCT00976404|B3|Baseline|Total|Total of all reporting groups
408343|NCT00976404|B2|Baseline|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408344|NCT00976404|B1|Baseline|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
408345|NCT00976404|P2|Participant Flow|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408346|NCT00976404|P1|Participant Flow|ART Intensification: Maraviroc + Raltegravir|ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks
408347|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408348|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
408349|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408350|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
408351|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408352|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
408353|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408354|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
408355|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408356|NCT00976404|O1|Outcome|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
408357|NCT00976404|E2|Reported Event|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
408417|NCT00976274|E2|Reported Event|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
408358|NCT00976404|E1|Reported Event|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
408359|NCT00976391|B3|Baseline|Total|Total of all reporting groups
408360|NCT00976391|B2|Baseline|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408361|NCT00976391|B1|Baseline|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408362|NCT00976391|P2|Participant Flow|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408363|NCT00976391|P1|Participant Flow|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408364|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408365|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408366|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408367|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408368|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408369|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408370|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408371|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408372|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408373|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408374|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408375|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408376|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408377|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408378|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
419200|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
408379|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408380|NCT00976391|E2|Reported Event|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
408381|NCT00976391|E1|Reported Event|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
408382|NCT00976352|B3|Baseline|Total|Total of all reporting groups
408383|NCT00976352|B2|Baseline|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408384|NCT00976352|B1|Baseline|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408385|NCT00976352|P2|Participant Flow|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408386|NCT00976352|P1|Participant Flow|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408387|NCT00976352|O2|Outcome|rAAV1-CMV-GAA Administration-cohort 2|RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing.
408388|NCT00976352|O1|Outcome|rAAV1-CMV-GAA Administration-cohort 1|RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing.
408389|NCT00976352|O2|Outcome|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing."
408390|NCT00976352|O1|Outcome|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270 after dosing."
408418|NCT00976274|E1|Reported Event|Starch Capsule|5 capsules three times everyday for 12 weeks
408419|NCT00976248|B1|Baseline|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
408420|NCT00976248|P1|Participant Flow|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
408421|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001: Taken orally once a day"
419201|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
408391|NCT00976352|O2|Outcome|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408392|NCT00976352|O1|Outcome|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408393|NCT00976352|O2|Outcome|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408394|NCT00976352|O1|Outcome|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408395|NCT00976352|E2|Reported Event|rAAV1-CMV-GAA Administration-cohort 2|"rAAV1-CMV-GAA (study agent) Administration: 5.0 x 10e12 vector genomes Cohort 2 = 6 subjects. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408396|NCT00976352|E1|Reported Event|rAAV1-CMV-GAA Administration-cohort 1|"rAAV1-CMV-GAA (study agent) Administration: 1.0 x 10e12 vector genomes. The following study assessments/interventions will be completed: Respiratory Muscle Strength Training (RMST), Safety labs, pulmonary function testing.~rAAV1-CMV-GAA (study agent) Administration: rAAV1-CMV-GAA via intramuscular injection into the diaphragm. Dose selection for cohort 1: 1.0 x 10e12 vector genomes Cohort 1 will have a total of 3 participants enrolled. Dose selection for cohort 2 and 3: 5.0 x 10e12 vector genomes rAAV1-CMV-GAA. Cohort 2 = 6 subjects.~RMST: After enrollment and screening visit, the subject will be given a RMST prescription and will complete RMST for a minimum of 4 weeks prior to study agent administration. RMST prescription will be adjusted as needed at Day 14, 90, 180, and 270."
408397|NCT00976339|B3|Baseline|Total|Total of all reporting groups
408398|NCT00976339|B2|Baseline|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly, for 1 year
408399|NCT00976339|B1|Baseline|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly, for 1 year
408400|NCT00976339|P2|Participant Flow|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly for one year
408401|NCT00976339|P1|Participant Flow|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly for 1 year.
408402|NCT00976339|O2|Outcome|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly, for 1 year
408403|NCT00976339|O1|Outcome|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly, for 1 year
408404|NCT00976339|O2|Outcome|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly 1 year
408405|NCT00976339|O1|Outcome|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly 1 year
408406|NCT00976339|E2|Reported Event|Cholecalciferol 30,000 IU|Subjects received Cholecalciferol 30,000 IU weekly 1 year
408407|NCT00976339|E1|Reported Event|Cholecalciferol 20,000 IU|Subjects received Cholecalciferol 20,000 IU weekly 1 year
408408|NCT00976274|B3|Baseline|Total|Total of all reporting groups
408409|NCT00976274|B2|Baseline|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
408410|NCT00976274|B1|Baseline|Starch Capsule|5 capsules three times everyday for 12 weeks
408411|NCT00976274|P2|Participant Flow|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
408412|NCT00976274|P1|Participant Flow|Starch Capsule|5 capsules three times everyday for 12 weeks
408413|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
408414|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
408415|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
408416|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
408422|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001: Taken orally once a day"
408423|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
408424|NCT00976248|E1|Reported Event|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
408425|NCT00976209|B3|Baseline|Total|Total of all reporting groups
408426|NCT00976209|B2|Baseline|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
408427|NCT00976209|B1|Baseline|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
408428|NCT00976209|P2|Participant Flow|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
408429|NCT00976209|P1|Participant Flow|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
408430|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
408431|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
408432|NCT00976209|E2|Reported Event|Phenylephrine HCl IR, 10 mg|Phenylephrine Hydrochloride (HCl) Immediate Release tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
408433|NCT00976209|E1|Reported Event|Phenylephrine HCl ER, 30 mg|Phenylephrine Hydrochloride (HCl) Extended Release (ER) tablets 30 mg taken every 12 hours, twice daily, for 3 days.
408434|NCT00976183|B1|Baseline|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
408435|NCT00976183|P1|Participant Flow|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
408436|NCT00976183|O1|Outcome|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
408437|NCT00976183|O1|Outcome|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
408438|NCT00976183|E1|Reported Event|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
408439|NCT00976027|B3|Baseline|Total|Total of all reporting groups
408440|NCT00976027|B2|Baseline|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
408441|NCT00976027|B1|Baseline|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
408442|NCT00976027|P2|Participant Flow|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
408443|NCT00976027|P1|Participant Flow|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
408444|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
408445|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
408446|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
408447|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
408448|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
408537|NCT00975637|B4|Baseline|Placebo|Placebo: Placebo SC
408449|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
408450|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
408451|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
408452|NCT00976027|E2|Reported Event|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
408453|NCT00976027|E1|Reported Event|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
408454|NCT00975975|B1|Baseline|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
408455|NCT00975975|P1|Participant Flow|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
408456|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
408457|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
408458|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
408459|NCT00975975|E1|Reported Event|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
408460|NCT00975923|B3|Baseline|Total|Total of all reporting groups
408461|NCT00975923|B2|Baseline|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
408462|NCT00975923|B1|Baseline|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
408463|NCT00975923|P2|Participant Flow|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
408464|NCT00975923|P1|Participant Flow|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
408465|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to only a Tool Kit of clinical guidelines and aides for quality improvement
408466|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
408467|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement
408468|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
408469|NCT00975923|E2|Reported Event|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for quality improvement
408470|NCT00975923|E1|Reported Event|Collaborative Group|Hospitals allocated randomly to the Collaborative Quality Improvement intervention with teleconferences and Tool Kit
408471|NCT00975806|B4|Baseline|Total|Total of all reporting groups
408472|NCT00975806|B3|Baseline|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408473|NCT00975806|B2|Baseline|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408474|NCT00975806|B1|Baseline|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle
408475|NCT00975806|P3|Participant Flow|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408476|NCT00975806|P2|Participant Flow|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408477|NCT00975806|P1|Participant Flow|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
408478|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408479|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408480|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
408481|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408482|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408483|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
408484|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408485|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408486|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
408487|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408488|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408489|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
408490|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408491|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408492|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
408493|NCT00975806|O1|Outcome|Phase 2: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
408494|NCT00975806|O1|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
408495|NCT00975806|E3|Reported Event|Cohort G|Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
408496|NCT00975806|E2|Reported Event|Cohort F|Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
408497|NCT00975806|E1|Reported Event|Cohort A|Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle
408498|NCT00975780|B3|Baseline|Total|Total of all reporting groups
408499|NCT00975780|B2|Baseline|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
408500|NCT00975780|B1|Baseline|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
408501|NCT00975780|P2|Participant Flow|Enhanced Oral Care|Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning
408502|NCT00975780|P1|Participant Flow|Usual Care|"The usual oral care provided at the nursing home~Usual oral care : Usual oral care and feeding positioning"
408503|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
408504|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
408505|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
408506|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
408507|NCT00975780|E2|Reported Event|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
408508|NCT00975780|E1|Reported Event|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
408509|NCT00975715|B3|Baseline|Total|Total of all reporting groups
408510|NCT00975715|B2|Baseline|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408511|NCT00975715|B1|Baseline|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408512|NCT00975715|P2|Participant Flow|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408513|NCT00975715|P1|Participant Flow|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408514|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408515|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408516|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408517|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408518|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408519|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408520|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408521|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408522|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408523|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408524|NCT00975715|E2|Reported Event|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
408525|NCT00975715|E1|Reported Event|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
408526|NCT00975689|B3|Baseline|Total|Total of all reporting groups
408527|NCT00975689|B2|Baseline|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
408528|NCT00975689|B1|Baseline|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
408529|NCT00975689|P2|Participant Flow|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
408530|NCT00975689|P1|Participant Flow|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
408531|NCT00975689|O2|Outcome|Placebo Phase|
408532|NCT00975689|O1|Outcome|NAC Phase|
408533|NCT00975689|E2|Reported Event|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
408534|NCT00975689|E1|Reported Event|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
408535|NCT00975637|B6|Baseline|Total|Total of all reporting groups
408536|NCT00975637|B5|Baseline|Broda 70 mg|AMG 827: 70 mg SC
408561|NCT00975611|B1|Baseline|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
408562|NCT00975611|P1|Participant Flow|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.
408563|NCT00975611|O1|Outcome|All Consented Subjects|
408564|NCT00975611|E1|Reported Event|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
408565|NCT00975585|B3|Baseline|Total|Total of all reporting groups
408566|NCT00975585|B2|Baseline|Lotrafilcon B|contact lens
408567|NCT00975585|B1|Baseline|Senofilcon A|contact lens
408568|NCT00975585|P2|Participant Flow|Lotrafilcon B|contact lens
408569|NCT00975585|P1|Participant Flow|Senofilcon A|contact lens
408570|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
408571|NCT00975585|O1|Outcome|Senofilcon A|contact lens
408572|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
408573|NCT00975585|O1|Outcome|Senofilcon A|contact lens
408574|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
408575|NCT00975585|O1|Outcome|Senofilcon A|contact lens
408576|NCT00975585|O2|Outcome|Lotrafilcon B at 4 Weeks|lotrafilcon B contact lens after four weeks of wear
408577|NCT00975585|O1|Outcome|Lotrafilcon B at 2 Weeks|lotrafilcon B contact lens after two weeks of wear
408578|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
408579|NCT00975585|O1|Outcome|Senofilcon A|contact lens
408580|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
408581|NCT00975585|O1|Outcome|Senofilcon A|contact lens
408582|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
408583|NCT00975585|O1|Outcome|Senofilcon A|contact lens
408584|NCT00975585|E2|Reported Event|Lotrafilcon B|contact lens
408585|NCT00975585|E1|Reported Event|Senofilcon A|contact lens
408586|NCT00975507|B3|Baseline|Total|Total of all reporting groups
408587|NCT00975507|B2|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
408588|NCT00975507|B1|Baseline|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
408589|NCT00975507|P2|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
408590|NCT00975507|P1|Participant Flow|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
408591|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
408592|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
408593|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
408594|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
408595|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
408596|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
408597|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
408598|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
408599|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
408600|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
408601|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
408602|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
408603|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
408604|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
408605|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
408606|NCT00975507|E3|Reported Event|M-M-R™ II + VARIVAX™ (1 Injection)|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
408607|NCT00975507|E2|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
408622|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408608|NCT00975507|E1|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0.
408609|NCT00975481|B1|Baseline|Entire Study Population|Includes participants randomized to receive placebo first, alprazolam 1 mg first, alprazolam 3 mg first, dimebon 20 mg first, dimebon 40 mg first and dimebon 60 mg first.
408610|NCT00975481|P6|Participant Flow|DIM 60 mg, PBO, DIM 40 mg, ALP 1mg, DIM 20 mg, ALP 3 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention group; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
408611|NCT00975481|P5|Participant Flow|DIM 40 mg, DIM 60 mg, DIM 20 mg, PBO, ALP 3 mg, ALP 1 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
408612|NCT00975481|P4|Participant Flow|DIM 20 mg, DIM 40 mg, ALP 3 mg, DIM 60 mg, ALP 1 mg, PBO|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then alprazolam 1mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
408613|NCT00975481|P3|Participant Flow|ALP 3 mg, DIM 20 mg, ALP 1 mg, DIM 40 mg, PBO, DIM 60 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fourth interventional period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of 7 days was maintained between each dose.
408614|NCT00975481|P2|Participant Flow|ALP 1 mg, ALP 3 mg, PBO, DIM 20 mg, DIM 60 mg, DIM 40 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
408615|NCT00975481|P1|Participant Flow|PBO, ALP 1mg, DIM 60 mg, ALP 3 mg, DIM 40 mg, DIM 20 mg|Placebo (PBO) matched to 3 alprazolam (ALP) capsules and placebo matched to 3 dimebon (DIM) tablets on Day 1 in the first intervention period; followed by alprazolam 1 milligram (mg) capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in fourth intervention period; then dimebon 40 mg tablets and placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
408616|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408617|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408618|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408619|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408620|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408621|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408623|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408624|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408625|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408626|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408627|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408628|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408629|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408630|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408631|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408632|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408633|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408634|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408635|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408636|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408637|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408638|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408639|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408640|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408641|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408642|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408643|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408644|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408645|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408646|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408647|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408648|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408649|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408650|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408651|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408652|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408653|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408654|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408655|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408656|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408657|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408658|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408659|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408660|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408661|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408662|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408663|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408664|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408665|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408666|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408667|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408668|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408669|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408670|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408671|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408672|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408673|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408674|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408675|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408676|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408677|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408678|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408679|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408680|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408681|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408682|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408683|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408684|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408685|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408686|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408687|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408688|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408689|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408690|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408691|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408692|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam tablets, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408693|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408694|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408695|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to 1 dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408696|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408697|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408698|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408699|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408700|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408701|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408702|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408703|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408704|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408705|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408706|NCT00975481|E6|Reported Event|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
408707|NCT00975481|E5|Reported Event|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408708|NCT00975481|E4|Reported Event|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
408709|NCT00975481|E3|Reported Event|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408710|NCT00975481|E2|Reported Event|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408711|NCT00975481|E1|Reported Event|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
408712|NCT00975416|B3|Baseline|Total|Total of all reporting groups
408713|NCT00975416|B2|Baseline|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal Placebo given in the context of cognitive behavioral therapy"
408714|NCT00975416|B1|Baseline|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
408715|NCT00975416|P2|Participant Flow|Inpatient Cocaine Placebo|Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy
408716|NCT00975416|P1|Participant Flow|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
408717|NCT00975416|O2|Outcome|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal placebo given in the context of cognitive behavioral therapy"
408718|NCT00975416|O1|Outcome|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
408719|NCT00975416|E3|Reported Event|Inpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
408720|NCT00975416|E2|Reported Event|Outpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
408721|NCT00975416|E1|Reported Event|Methadone|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
408722|NCT00975286|B3|Baseline|Total|Total of all reporting groups
408723|NCT00975286|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
408724|NCT00975286|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
408725|NCT00975286|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
408726|NCT00975286|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
408727|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408728|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408729|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408730|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408731|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408732|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408733|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408734|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408735|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408736|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408737|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408738|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408739|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408740|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408741|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408742|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408743|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408744|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408745|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408746|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408747|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408748|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408749|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408750|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408751|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
408752|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
408753|NCT00975286|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
408754|NCT00975286|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
408755|NCT00975221|B3|Baseline|Total|Total of all reporting groups
408756|NCT00975221|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408757|NCT00975221|B1|Baseline|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408758|NCT00975221|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408759|NCT00975221|P1|Participant Flow|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408760|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408761|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408762|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408763|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408764|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408796|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408765|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408766|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408767|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408768|NCT00975221|E4|Reported Event|Open-label Phase: Previous Cinacalcet|Participants who received cinacalcet during the double-blind phase continued to receive cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408769|NCT00975221|E3|Reported Event|Open-label Phase: Previous Placebo|Participants who received placebo during the double-blind phase (Weeks 1-28) then received cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
408770|NCT00975221|E2|Reported Event|Double-blind Phase: Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week double-blind dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the double-blind efficacy assessment phase.
408771|NCT00975221|E1|Reported Event|Double-blind Phase: Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase.
408772|NCT00975195|B3|Baseline|Total|Total of all reporting groups
408773|NCT00975195|B2|Baseline|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408774|NCT00975195|B1|Baseline|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408775|NCT00975195|P2|Participant Flow|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408776|NCT00975195|P1|Participant Flow|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408777|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408778|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408779|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408780|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408812|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408781|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408782|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408783|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408784|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408785|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408786|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408787|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408788|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408789|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408790|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408791|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408792|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408793|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408794|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408795|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408857|NCT00975143|E2|Reported Event|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408797|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408798|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408799|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408800|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408801|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408802|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408803|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408804|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408805|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408806|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408807|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408808|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408809|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408810|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408811|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408858|NCT00975143|E1|Reported Event|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408813|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408814|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408815|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408816|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408817|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408818|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408819|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408820|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408821|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408822|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408823|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408824|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408825|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408826|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408827|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408859|NCT00975130|B1|Baseline|GLM50-SC|Participants received 50 mg of golimumab subcutaneously once monthly for a period of 6 months. 3280 enrolled participants were included in the Efficacy-Evaluable population; baseline characteristics are presented for this population.
408828|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408829|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408830|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408831|NCT00975195|E2|Reported Event|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
408832|NCT00975195|E1|Reported Event|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
408833|NCT00975156|B3|Baseline|Total|Total of all reporting groups
408834|NCT00975156|B2|Baseline|Standard of Care|Conventional physical therapy
408835|NCT00975156|B1|Baseline|Lokomat Intervention|
408836|NCT00975156|P2|Participant Flow|Standard of Care|Conventional physical therapy
408837|NCT00975156|P1|Participant Flow|Lokomat Intervention|
408838|NCT00975156|O3|Outcome|All Participants 6MWD Outcome|Baseline, Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
408839|NCT00975156|O2|Outcome|Standard of Care 6MWD Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
408840|NCT00975156|O1|Outcome|Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
408841|NCT00975156|O3|Outcome|All Participants 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
408842|NCT00975156|O2|Outcome|Standard of Care 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
408843|NCT00975156|O1|Outcome|Lokomat Intervention 10-meter Walking Test (10mWT) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
408844|NCT00975156|E2|Reported Event|Standard of Care|Conventional physical therapy
408845|NCT00975156|E1|Reported Event|Lokomat Intervention|Robotic-assisted gait therapy
408846|NCT00975143|B3|Baseline|Total|Total of all reporting groups
408847|NCT00975143|B2|Baseline|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408848|NCT00975143|B1|Baseline|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408849|NCT00975143|P2|Participant Flow|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408850|NCT00975143|P1|Participant Flow|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408851|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408852|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408853|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408854|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408855|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408856|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
408860|NCT00975130|P3|Participant Flow|SC-GLM50|Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
408861|NCT00975130|P2|Participant Flow|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly.
408862|NCT00975130|P1|Participant Flow|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1.
408863|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
408864|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|Participants received IV GLM at a dose of 2 mg/kg until remission is achieved at which time they were switched to SC GLM at a dose of 50 mg once monthly.
408865|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
408866|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched to subcutaneous golimumab~at a dose of 50 mg once monthly."
408867|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
408868|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408869|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408870|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408871|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408872|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408873|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408874|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408875|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408876|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408877|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408878|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408879|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408880|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408881|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408882|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408883|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
408884|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408885|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408886|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408887|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408888|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408889|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408890|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408891|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408892|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408893|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408894|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408895|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408896|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408897|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408898|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408899|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
408900|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
408901|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
408902|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408903|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408904|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408905|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408906|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408907|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408908|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408909|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408910|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408911|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408912|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408913|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408914|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408915|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408916|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408917|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408918|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408919|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408920|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408921|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408922|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408923|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408924|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408925|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408926|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408927|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408928|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408929|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408930|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408931|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408932|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408933|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408934|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408935|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408936|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408937|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408938|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408939|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408940|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408941|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408942|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408943|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408944|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408945|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408946|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408947|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408948|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408949|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408950|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408951|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408952|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408953|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408954|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408955|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408956|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408957|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408958|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408959|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408960|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408961|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408962|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408963|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408964|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408965|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408966|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408967|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408968|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408969|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408970|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408971|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408972|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408973|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408974|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408975|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408976|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408977|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408978|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408979|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408980|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408981|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408982|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408983|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408984|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408985|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408986|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408987|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408988|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408989|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408990|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408991|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408992|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408993|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408994|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408995|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408996|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408997|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408998|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
408999|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409000|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409001|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409002|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409003|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409004|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409005|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409006|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409007|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409008|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409009|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409010|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409011|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409012|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409013|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409014|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409015|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409016|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409017|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409018|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409019|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409020|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409021|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409022|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409023|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409024|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409025|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409026|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409027|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409028|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409029|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409030|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409031|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409032|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409033|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409034|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409035|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409036|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
409037|NCT00975130|O2|Outcome|SC-GLM50|Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
409038|NCT00975130|O1|Outcome|IV-GLM2/SC-GLM50|Intravenous golimumab 2 mg/kg followed by subcutaneous golimumab 50 mg once monthly.
409039|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
409040|NCT00975130|E3|Reported Event|SC-GLM50|Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
409041|NCT00975130|E2|Reported Event|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab~at a dose of 50 mg once monthly."
409042|NCT00975130|E1|Reported Event|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months.
409043|NCT00975000|B3|Baseline|Total|Total of all reporting groups
419202|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
409044|NCT00975000|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409045|NCT00975000|B1|Baseline|Placebo|Participants received placebo orally once daily for 52 weeks.
409046|NCT00975000|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parathyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
409047|NCT00975000|P1|Participant Flow|Placebo|Participants received placebo orally once daily for 52 weeks.
409048|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409049|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409050|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409051|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409052|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409053|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409054|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409055|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409056|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409057|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409058|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409059|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409060|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409061|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409062|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409063|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409064|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409065|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
409066|NCT00975000|E2|Reported Event|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
409067|NCT00975000|E1|Reported Event|Placebo|Participants received placebo orally once daily for 52 weeks.
409068|NCT00974974|B3|Baseline|Total|Total of all reporting groups
409069|NCT00974974|B2|Baseline|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
409070|NCT00974974|B1|Baseline|IPX066|Investigational product IPX066
409071|NCT00974974|P2|Participant Flow|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
409072|NCT00974974|P1|Participant Flow|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
409073|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
409074|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
409075|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
409076|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
409077|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
409098|NCT00974675|B2|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409078|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
409079|NCT00974974|E2|Reported Event|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
409080|NCT00974974|E1|Reported Event|IPX066|Investigational product IPX066
409081|NCT00974922|B1|Baseline|Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3|"Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.~Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks."
409082|NCT00974922|P1|Participant Flow|Aliskiren and Vitamin D3 AND Aliskiren Versus Vitamin D3|Study stopped prematurely. Intervention groups combined because data were never unblinded.
409083|NCT00974922|O1|Outcome|Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3|"Phase I: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.~Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks."
409084|NCT00974922|O1|Outcome|Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3|"Phase I: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.~Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks."
409085|NCT00974922|E1|Reported Event|Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3|"Phase I: Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.~Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks."
409086|NCT00974818|B3|Baseline|Total|Total of all reporting groups
409087|NCT00974818|B2|Baseline|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
409088|NCT00974818|B1|Baseline|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
409089|NCT00974818|P2|Participant Flow|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
409090|NCT00974818|P1|Participant Flow|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
409091|NCT00974818|O2|Outcome|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
409092|NCT00974818|O1|Outcome|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
409093|NCT00974818|E2|Reported Event|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
409094|NCT00974818|E1|Reported Event|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
409095|NCT00974675|B5|Baseline|Total|Total of all reporting groups
409096|NCT00974675|B4|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
409097|NCT00974675|B3|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
419203|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
409099|NCT00974675|B1|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409100|NCT00974675|P4|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
409101|NCT00974675|P3|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409102|NCT00974675|P2|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409103|NCT00974675|P1|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409104|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409105|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409106|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409107|NCT00974675|O4|Outcome|Placebp|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
409108|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409109|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409110|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409111|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409112|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409113|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409114|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409115|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409116|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409117|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409118|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409119|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409120|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409121|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409122|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409123|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409124|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409125|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409126|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409127|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409128|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409129|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409130|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409131|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409132|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409133|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409134|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409135|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409136|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409137|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409138|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409139|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409140|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409141|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409142|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409143|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409144|NCT00974675|E4|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
409145|NCT00974675|E3|Reported Event|10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
419204|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
409146|NCT00974675|E2|Reported Event|5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409147|NCT00974675|E1|Reported Event|1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
409148|NCT00974571|B4|Baseline|Total|Total of all reporting groups
409149|NCT00974571|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409150|NCT00974571|B2|Baseline|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409151|NCT00974571|B1|Baseline|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409152|NCT00974571|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409153|NCT00974571|P2|Participant Flow|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409154|NCT00974571|P1|Participant Flow|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409155|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409156|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409157|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409158|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409159|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409160|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409161|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409162|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409163|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409164|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409165|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409166|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409167|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409168|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409169|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409170|NCT00974571|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409171|NCT00974571|E2|Reported Event|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
409172|NCT00974571|E1|Reported Event|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
409173|NCT00974480|B4|Baseline|Total|Total of all reporting groups
409174|NCT00974480|B3|Baseline|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409175|NCT00974480|B2|Baseline|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409176|NCT00974480|B1|Baseline|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409177|NCT00974480|P3|Participant Flow|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409178|NCT00974480|P2|Participant Flow|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409179|NCT00974480|P1|Participant Flow|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409200|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409250|NCT00974311|B1|Baseline|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409180|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409181|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409182|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409183|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409184|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409185|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409186|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409187|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409188|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409189|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409190|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409191|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409192|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409193|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409194|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409195|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409196|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409197|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409198|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409199|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409201|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409202|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409203|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409204|NCT00974480|O6|Outcome|Combination of Redermic and Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409205|NCT00974480|O5|Outcome|Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409206|NCT00974480|O4|Outcome|Redermic - Assessor 2|Cream applied twice a day every day, morning and evening for 24 weeks.
409207|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409208|NCT00974480|O2|Outcome|Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409209|NCT00974480|O1|Outcome|Redermic - Assessor 1|Cream applied twice a day every day, morning and evening for 24 weeks.
409210|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409211|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409212|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409213|NCT00974480|E3|Reported Event|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
409214|NCT00974480|E2|Reported Event|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
409215|NCT00974480|E1|Reported Event|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
409216|NCT00974376|B3|Baseline|Total|Total of all reporting groups
409217|NCT00974376|B2|Baseline|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
409218|NCT00974376|B1|Baseline|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
409219|NCT00974376|P2|Participant Flow|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
409220|NCT00974376|P1|Participant Flow|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
409221|NCT00974376|O2|Outcome|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
409222|NCT00974376|O1|Outcome|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
409223|NCT00974376|E2|Reported Event|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
409224|NCT00974376|E1|Reported Event|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
409225|NCT00974363|B3|Baseline|Total|Total of all reporting groups
409226|NCT00974363|B2|Baseline|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409318|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409227|NCT00974363|B1|Baseline|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409228|NCT00974363|P2|Participant Flow|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409229|NCT00974363|P1|Participant Flow|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409230|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409231|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409232|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409233|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409234|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409235|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409236|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409237|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409238|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409239|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409240|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409241|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409242|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409243|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409244|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409245|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409246|NCT00974363|E2|Reported Event|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409247|NCT00974363|E1|Reported Event|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
409248|NCT00974311|B3|Baseline|Total|Total of all reporting groups
409249|NCT00974311|B2|Baseline|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409319|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409251|NCT00974311|P2|Participant Flow|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409252|NCT00974311|P1|Participant Flow|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409253|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409254|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409255|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409256|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409257|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409258|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409259|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409260|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409261|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409262|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409263|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409264|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409265|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409266|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409267|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409268|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409269|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409270|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409271|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409272|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409273|NCT00974311|E2|Reported Event|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409274|NCT00974311|E1|Reported Event|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death, or withdrawal.
409275|NCT00974246|B1|Baseline|Baseline Characteristics|Nursing Home residents with either a confirmed diagnosis of COPD or an FEV1/FVC ratio <0.7 or in treatment with anticholinergic drugs.
409276|NCT00974246|P1|Participant Flow|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
409277|NCT00974246|O1|Outcome|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
409278|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
409279|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
409280|NCT00974246|E1|Reported Event|Adverse Events|All enrolled subjects.
409281|NCT00974233|B1|Baseline|Overall Study Population|Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).
409282|NCT00974233|P1|Participant Flow|Induction Chemoimmunotherapy + Maintenance Lenalidomide|Induction therapy: Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. Maintenance therapy: Lenalidomide 5-10 mg orally continuously of each 28-day cycles for total of 12 treatment cycles.
409283|NCT00974233|O1|Outcome|Overall Study Population|Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).
409284|NCT00974233|O2|Outcome|Maintenance|Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
409285|NCT00974233|O1|Outcome|Induction Chemoimmunotherapy|Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
409286|NCT00974233|O4|Outcome|Overall Response Rate|Includes complete and partial responses.
409287|NCT00974233|O3|Outcome|Stable Disease|Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
409288|NCT00974233|O2|Outcome|Partial Response (PR)|Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
409289|NCT00974233|O1|Outcome|Complete Response (CR)|Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow.
409290|NCT00974233|O1|Outcome|Induction/Maintenance Chemotherapy|"Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy~Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles~Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles~Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol."
409291|NCT00974233|O1|Outcome|Induction/Maintenance Chemotherapy|"Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy~Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles~Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles~Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol."
409292|NCT00974233|E2|Reported Event|Maintenance|Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
409293|NCT00974233|E1|Reported Event|Induction Chemoimmunotherapy|Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
409294|NCT00974220|B3|Baseline|Total|Total of all reporting groups
409295|NCT00974220|B2|Baseline|Fentanyl - Placebo (Order)|nebulized fentanyl citrate in period 1, nebulized saline placebo in period 2.
409296|NCT00974220|B1|Baseline|Placebo - Fentanyl (Order)|nebulized saline placebo in period 1, nebulized fentanyl citrate in period 2.
409297|NCT00974220|P2|Participant Flow|Fentanyl - Placebo (Order)|nebulized fentanyl citrate (50 mcg) in period 1, nebulized 0.9% saline placebo in period 2
409298|NCT00974220|P1|Participant Flow|Placebo - Fentanyl (Order)|nebulized 0.9% saline placebo in period 1, nebulized fentanyl citrate 50mcg in period 2
409299|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
409300|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
409301|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
409302|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
409303|NCT00974220|E2|Reported Event|Fentanyl|nebulized fentanyl citrate (50 mcg)
409304|NCT00974220|E1|Reported Event|Placebo|nebulized 0.9% saline placebo
409305|NCT00974142|B3|Baseline|Total|Total of all reporting groups
409306|NCT00974142|B2|Baseline|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409307|NCT00974142|B1|Baseline|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409308|NCT00974142|P2|Participant Flow|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409309|NCT00974142|P1|Participant Flow|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409310|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409311|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409312|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409313|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409314|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409315|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409316|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409317|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409320|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409321|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409322|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409323|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409324|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409325|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409326|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409327|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409328|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409329|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409330|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409331|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409332|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409333|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409334|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409335|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409336|NCT00974142|O2|Outcome|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409337|NCT00974142|O1|Outcome|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409338|NCT00974142|E2|Reported Event|Placebo|Randomized to placebo capsules identical in appearance to cyclosporine
409339|NCT00974142|E1|Reported Event|Cyclosporine|Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
409340|NCT00974090|B3|Baseline|Total|Total of all reporting groups
409341|NCT00974090|B2|Baseline|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409342|NCT00974090|B1|Baseline|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409343|NCT00974090|P2|Participant Flow|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409344|NCT00974090|P1|Participant Flow|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409345|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409346|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409347|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409348|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409349|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409350|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409351|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409352|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
409353|NCT00974090|E4|Reported Event|Teneli/Teneli + SU (Data Through Week 52)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
409354|NCT00974090|E3|Reported Event|Placebo/Teneli + SU (Data From Week 12 to Week 52)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
409355|NCT00974090|E2|Reported Event|Teneli/Teneli + SU (Data Through Week 12)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
409356|NCT00974090|E1|Reported Event|Placebo/Teneli + SU (Data Through Week 12)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
409357|NCT00974051|B1|Baseline|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
409358|NCT00974051|P3|Participant Flow|20% Basal Reduction First, Then Control, Then Terbutaline|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
409425|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
419205|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
409359|NCT00974051|P2|Participant Flow|Terbutaline First, Then 20% Basal Reduction, Then Control|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
409360|NCT00974051|P1|Participant Flow|Control First, Then Terbutaline, Then 20% Basal Reduction|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
409361|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
409362|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
409363|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
409364|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
409365|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
409366|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
409367|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
409368|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
409369|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
409370|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
409371|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
409372|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
409373|NCT00974051|E4|Reported Event|20% Basal Reduction Arm|During 20% basal reduction night
409374|NCT00974051|E3|Reported Event|Terbutaline Arm|During turbutaline intervention night
409375|NCT00974051|E2|Reported Event|Control Arm|during control intervention night
409376|NCT00974051|E1|Reported Event|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
409377|NCT00973921|B1|Baseline|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
409378|NCT00973921|P1|Participant Flow|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
409379|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
409380|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
409381|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
409382|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
409383|NCT00973921|E1|Reported Event|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
409384|NCT00973765|B3|Baseline|Total|Total of all reporting groups
409385|NCT00973765|B2|Baseline|Placebo|Matched placebo 2 pills po BID x 7 days
409386|NCT00973765|B1|Baseline|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
409387|NCT00973765|P2|Participant Flow|Placebo|Matched placebo 2 pills po BID x 7 days
409388|NCT00973765|P1|Participant Flow|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
409389|NCT00973765|O2|Outcome|Placebo|Matched placebo 2 pills po BID x 7 days
409390|NCT00973765|O1|Outcome|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
409391|NCT00973765|E2|Reported Event|Placebo|Matched placebo 2 pills po BID x 7 days
409392|NCT00973765|E1|Reported Event|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
409426|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409427|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409428|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409393|NCT00973752|B1|Baseline|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
409394|NCT00973752|P1|Participant Flow|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS (central nervous system), Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
409395|NCT00973752|O1|Outcome|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
409396|NCT00973752|E1|Reported Event|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
409397|NCT00973739|B1|Baseline|Lapatinib|Lapatinib will be administered
409398|NCT00973739|P1|Participant Flow|Lapatinib|Lapatinib will be administered
409399|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
409400|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
409401|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
409402|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
409403|NCT00973739|E1|Reported Event|Lapatinib|Lapatinib will be administered
409404|NCT00973700|B6|Baseline|Total|Total of all reporting groups
409405|NCT00973700|B5|Baseline|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409406|NCT00973700|B4|Baseline|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409407|NCT00973700|B3|Baseline|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409408|NCT00973700|B2|Baseline|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
409409|NCT00973700|B1|Baseline|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
409410|NCT00973700|P5|Participant Flow|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409411|NCT00973700|P4|Participant Flow|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409412|NCT00973700|P3|Participant Flow|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409413|NCT00973700|P2|Participant Flow|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
409414|NCT00973700|P1|Participant Flow|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
409415|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409416|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409417|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409418|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
409419|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
409420|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409421|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409422|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409423|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409424|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409429|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
409430|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
409431|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409432|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409433|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409434|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
409435|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
409436|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409437|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409438|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409439|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409440|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409441|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409442|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
409443|NCT00973700|O4|Outcome|15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
409444|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
409445|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; two doses on day 1
409446|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
409447|NCT00973700|O1|Outcome|15_1_22|A/H1N1 on study days 1 and 22
409448|NCT00973700|O1|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409449|NCT00973700|E11|Reported Event|2x15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409450|NCT00973700|E10|Reported Event|15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409451|NCT00973700|E9|Reported Event|7.5adj_1_22 (3 to <9 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409452|NCT00973700|E8|Reported Event|2x15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409453|NCT00973700|E7|Reported Event|15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409454|NCT00973700|E6|Reported Event|7.5adj_1_22 (9 to 17 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409455|NCT00973700|E5|Reported Event|2x15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
409456|NCT00973700|E4|Reported Event|15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
409457|NCT00973700|E3|Reported Event|7.5adj_1_22 (18-64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
409458|NCT00973700|E2|Reported Event|7.5adj_1_8 (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
409459|NCT00973700|E1|Reported Event|2x7.5adj (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; two doses on day 1
409460|NCT00973622|B3|Baseline|Total|Total of all reporting groups
409461|NCT00973622|B2|Baseline|Nonsmokers|
409462|NCT00973622|B1|Baseline|Smokers|
409463|NCT00973622|P2|Participant Flow|Non-smokers|Healthy adult non-smokers who were between the ages of aged 19-55 years.
409464|NCT00973622|P1|Participant Flow|Smokers|Smokers were healthy adults between the ages of 19 and 55 years who had no intention of quitting smoking before the end of the study.
409465|NCT00973622|O2|Outcome|Non-smokers|Healthy adult non-smokers aged 19-55
409466|NCT00973622|O1|Outcome|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
409467|NCT00973622|E2|Reported Event|Non-smokers|Healthy adult non-smokers aged 19-55
409468|NCT00973622|E1|Reported Event|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
409469|NCT00973479|B3|Baseline|Total|Total of all reporting groups
409470|NCT00973479|B2|Baseline|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
409471|NCT00973479|B1|Baseline|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
409472|NCT00973479|P2|Participant Flow|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
409473|NCT00973479|P1|Participant Flow|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
409474|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
409512|NCT00973349|B5|Baseline|15 w/o MF59 (18 to 64)|1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age
409513|NCT00973349|B4|Baseline|7.5_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
409475|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
409476|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
409477|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
409478|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
409479|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
409480|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
409481|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
409482|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
409483|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
409484|NCT00973479|E4|Reported Event|Combined Golimumab|Participants in the reporting groups: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
409485|NCT00973479|E3|Reported Event|Golimumab 2 mg/kg + MTX|Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
409486|NCT00973479|E2|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24|Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
409487|NCT00973479|E1|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16|Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
409488|NCT00973362|B3|Baseline|Total|Total of all reporting groups
409489|NCT00973362|B2|Baseline|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
409514|NCT00973349|B3|Baseline|7.5_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
409515|NCT00973349|B2|Baseline|7.5 w/o MF59 (18 to 64)|1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age
409516|NCT00973349|B1|Baseline|3.75_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age
409490|NCT00973362|B1|Baseline|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
409491|NCT00973362|P2|Participant Flow|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).~There is no follow-up period for the ASC-US Arm of the study, only for the Adjunct ARM has a three (3) year follow-up period."
409492|NCT00973362|P1|Participant Flow|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
409493|NCT00973362|O1|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
409494|NCT00973362|O2|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
409495|NCT00973362|O1|Outcome|APTIMA HPV Assay|APTIMA HPV Assay Performed on the Tigris System
409496|NCT00973362|O1|Outcome|FDA-Approved DNA Test|A FDA-Approved HPV DNA Test is the comparator assay,
409497|NCT00973362|O1|Outcome|APTIMA HPV Assay|"The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
409498|NCT00973362|E2|Reported Event|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
409499|NCT00973362|E1|Reported Event|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
409500|NCT00973349|B17|Baseline|Total|Total of all reporting groups
409501|NCT00973349|B16|Baseline|30 w/o MF59 (≥ 65)|1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age
409502|NCT00973349|B15|Baseline|15_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
409503|NCT00973349|B14|Baseline|15_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
409504|NCT00973349|B13|Baseline|15 w/o MF59 (≥ 65)|1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age
409505|NCT00973349|B12|Baseline|7.5_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
409506|NCT00973349|B11|Baseline|7.5_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
409507|NCT00973349|B10|Baseline|7.5 w/o MF59 (≥ 65)|1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age
409508|NCT00973349|B9|Baseline|3.75_(50)MF59 (≥ 65 )|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age
409509|NCT00973349|B8|Baseline|30 w/o MF59 (18 to 64)|1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age
409510|NCT00973349|B7|Baseline|15_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen
409511|NCT00973349|B6|Baseline|15_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age
409517|NCT00973349|P16|Participant Flow|30 w/o MF59(≥ 65 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409518|NCT00973349|P15|Participant Flow|15_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409519|NCT00973349|P14|Participant Flow|15_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409520|NCT00973349|P13|Participant Flow|15 w/o MF59 (≥ 65 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409521|NCT00973349|P12|Participant Flow|7.5_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409522|NCT00973349|P11|Participant Flow|7.5_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409523|NCT00973349|P10|Participant Flow|7.5 w/o MF59 (≥ 65 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409524|NCT00973349|P9|Participant Flow|3.75_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409525|NCT00973349|P8|Participant Flow|30 w/o MF59(18-64 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409526|NCT00973349|P7|Participant Flow|15_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409527|NCT00973349|P6|Participant Flow|15_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409528|NCT00973349|P5|Participant Flow|15 w/o MF59 (18-64 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409529|NCT00973349|P4|Participant Flow|7.5_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409530|NCT00973349|P3|Participant Flow|7.5_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409531|NCT00973349|P2|Participant Flow|7.5 w/o MF59 (18-64 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409532|NCT00973349|P1|Participant Flow|3.75_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409533|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409534|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409535|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409536|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409537|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409538|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409539|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409540|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409541|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409542|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409543|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409544|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409545|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409546|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409547|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409548|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409549|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409550|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409551|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409552|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409553|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409554|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409555|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409556|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409557|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409558|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409559|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409560|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409561|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409562|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409563|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409564|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409565|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409566|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409567|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409568|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409569|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409570|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409571|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409572|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409573|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409574|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409575|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409576|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409577|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409578|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409579|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409580|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409581|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409582|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409583|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409584|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409585|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409586|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409587|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409588|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409589|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409590|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409591|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409592|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409593|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409594|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409595|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409596|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409597|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409598|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409599|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409600|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409601|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409602|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409603|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409604|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409605|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
409606|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409607|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
409608|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
409609|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409610|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
409611|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
409612|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
409613|NCT00973349|E16|Reported Event|30 w/o MF59 (≥65 Yrs)|1 dose of 30 µg A/H1N1
409614|NCT00973349|E15|Reported Event|15_(100)MF59 (≥65 Yrs)|100% of MF59 with 15 µg A/H1N1 antigen
409615|NCT00973349|E14|Reported Event|15_(50)MF59 (≥65 Yrs)|50% of MF59 with 15 µg A/H1N1 antigen
409616|NCT00973349|E13|Reported Event|15 w/o MF59 (≥ 65 Yrs)|1 dose of 15 µg A/H1N1
409617|NCT00973349|E12|Reported Event|7.5_(100)MF59 (≥65 Yrs)|100% of MF59 with 7.5 µg A/H1N1 antigen
409618|NCT00973349|E11|Reported Event|7.5_(50)MF59 (≥65 Yrs)|50% of MF59 with 7.5 µg A/H1N1 antigen
409619|NCT00973349|E10|Reported Event|7.5 w/o MF59 (≥65 Yrs)|1 dose of 7.5 µg A/H1N1
409620|NCT00973349|E9|Reported Event|3.75_(50)MF59 (Above 65 Yrs)|50% of MF59 with the lowest amount of A/H1N1 antigen
409621|NCT00973349|E8|Reported Event|30 w/o MF59|1 dose of 30 µg A/H1N1
409622|NCT00973349|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409623|NCT00973349|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409624|NCT00973349|E5|Reported Event|15 w/o MF59|1 dose of 15 µg A/H1N1
409625|NCT00973349|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409626|NCT00973349|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409627|NCT00973349|E2|Reported Event|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1
409628|NCT00973349|E1|Reported Event|3.75_(50)MF59|50% of MF59 with the lowest amount of A/H1N1 antigen
409629|NCT00972959|B1|Baseline|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409630|NCT00972959|P1|Participant Flow|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409631|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409632|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409633|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409634|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409635|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409636|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409659|NCT00972816|P2|Participant Flow|7.5_(0) MF59|7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
409660|NCT00972816|P1|Participant Flow|3.75_(50) MF59|3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
409661|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409637|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409638|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409639|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409640|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409641|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409642|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409643|NCT00972959|E1|Reported Event|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
409644|NCT00972816|B9|Baseline|Total|Total of all reporting groups
409645|NCT00972816|B8|Baseline|30 Without MF59|1 dose of 30 µg A/H1N1
409646|NCT00972816|B7|Baseline|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409647|NCT00972816|B6|Baseline|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409648|NCT00972816|B5|Baseline|15 Without MF59|1 dose of 15 µg A/H1N1
409649|NCT00972816|B4|Baseline|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409650|NCT00972816|B3|Baseline|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409651|NCT00972816|B2|Baseline|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409652|NCT00972816|B1|Baseline|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409653|NCT00972816|P8|Participant Flow|30_(0) MF59|30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
409654|NCT00972816|P7|Participant Flow|15_(100) MF59|15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
409655|NCT00972816|P6|Participant Flow|15_(50) MF59|15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
409656|NCT00972816|P5|Participant Flow|15_(0) MF59|15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
409657|NCT00972816|P4|Participant Flow|7.5_(100)MF59|7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
409658|NCT00972816|P3|Participant Flow|7.5_(50)MF59|7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
409662|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409663|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409664|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409665|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409666|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409667|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409668|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409669|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409670|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409671|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409672|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409673|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409674|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409675|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409676|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409677|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409678|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409679|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409680|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409681|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409682|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409683|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409684|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409685|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409686|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409687|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409688|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409689|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409690|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409691|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409692|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409693|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409694|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409695|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409696|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409697|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409698|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409699|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409700|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409701|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409702|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409703|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409704|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409705|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409706|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409707|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409708|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409709|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409710|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409711|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409712|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409713|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409714|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409715|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409716|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409717|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409718|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409719|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409720|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409721|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409722|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409723|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409724|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409725|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
409726|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409727|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409728|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
409729|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
409730|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409731|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409732|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409733|NCT00972816|E8|Reported Event|30 Without MF59|1 dose of 30 µg A/H1N1
409734|NCT00972816|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
409735|NCT00972816|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
409736|NCT00972816|E5|Reported Event|15 Without MF59|1 dose of 15 µg A/H1N1
409737|NCT00972816|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
419206|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
409738|NCT00972816|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
409739|NCT00972816|E2|Reported Event|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
409740|NCT00972816|E1|Reported Event|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
409741|NCT00972777|B3|Baseline|Total|Total of all reporting groups
409742|NCT00972777|B2|Baseline|Vehicle|Vehicle of besifloxacin ophthalmic suspension
409743|NCT00972777|B1|Baseline|Besifloxacin|0.6% ophthalmic suspension
409744|NCT00972777|P2|Participant Flow|Vehicle|Vehicle of besifloxacin ophthalmic suspension
409745|NCT00972777|P1|Participant Flow|Besifloxacin|0.6% ophthalmic suspension
409746|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
409747|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
409748|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
409749|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
409750|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
409751|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
409752|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
409753|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
409754|NCT00972777|E2|Reported Event|Vehicle|Vehicle of besifloxacin ophthalmic suspension
409755|NCT00972777|E1|Reported Event|Besifloxacin|0.6% ophthalmic suspension
409756|NCT00972738|B4|Baseline|Total|Total of all reporting groups
409757|NCT00972738|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409758|NCT00972738|B2|Baseline|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409759|NCT00972738|B1|Baseline|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409760|NCT00972738|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409761|NCT00972738|P2|Participant Flow|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409762|NCT00972738|P1|Participant Flow|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409763|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409764|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409765|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409766|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409767|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409768|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409769|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409770|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409771|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409772|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409773|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409774|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409775|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409776|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409777|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409778|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409779|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409780|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409781|NCT00972738|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409782|NCT00972738|E2|Reported Event|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409783|NCT00972738|E1|Reported Event|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
409784|NCT00972725|B3|Baseline|Total|Total of all reporting groups
409785|NCT00972725|B2|Baseline|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409786|NCT00972725|B1|Baseline|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409972|NCT00972530|E1|Reported Event|Activity|Normal activity without restrictions
409787|NCT00972725|P2|Participant Flow|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409788|NCT00972725|P1|Participant Flow|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409789|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409790|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409791|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409792|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409793|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409794|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409795|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409796|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409797|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409798|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409799|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409800|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409801|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409802|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409803|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409804|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409805|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409806|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409807|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409808|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409809|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409810|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409811|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409812|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409813|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409814|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409815|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409816|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409817|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409818|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409819|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409820|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409821|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409822|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409823|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409824|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409825|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409826|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409827|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409828|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409829|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409830|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409831|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409832|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409833|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409834|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409835|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409836|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409837|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409838|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409839|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409840|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409841|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409842|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409843|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409844|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409845|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409846|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409847|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409848|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409849|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409850|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409851|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409852|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409853|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409854|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409855|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409856|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409857|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409858|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409859|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409860|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409861|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409862|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409863|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409864|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409865|NCT00972725|E2|Reported Event|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
409866|NCT00972725|E1|Reported Event|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
409867|NCT00972621|B3|Baseline|Total|Total of all reporting groups
409868|NCT00972621|B2|Baseline|Viscoat|Currently marketed viscoelastic
409869|NCT00972621|B1|Baseline|Vitrax II|Investigational dispersive viscoelastic
409870|NCT00972621|P2|Participant Flow|Viscoat|Currently marketed viscoelastic
409871|NCT00972621|P1|Participant Flow|Vitrax II|Investigational dispersive viscoelastic
409872|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
409873|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
409874|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
409875|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
409876|NCT00972621|E2|Reported Event|Viscoat|Currently marketed viscoelastic
409877|NCT00972621|E1|Reported Event|Vitrax II|Investigational dispersive viscoelastic
409878|NCT00972595|B1|Baseline|All Participants|All Randomized Participants
409879|NCT00972595|P2|Participant Flow|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
409880|NCT00972595|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
409881|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
409882|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
409883|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
409884|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
409885|NCT00972595|E2|Reported Event|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
409886|NCT00972595|E1|Reported Event|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
409887|NCT00972543|B3|Baseline|Total|Total of all reporting groups
409888|NCT00972543|B2|Baseline|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409889|NCT00972543|B1|Baseline|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409890|NCT00972543|P2|Participant Flow|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409891|NCT00972543|P1|Participant Flow|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409892|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409893|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409894|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409895|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409896|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409897|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409898|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409899|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409900|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409901|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409902|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
410037|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
409903|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409904|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409905|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409906|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409907|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409908|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409909|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409910|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409911|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409912|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409913|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409914|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409915|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409916|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409917|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409918|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409919|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409920|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409921|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409922|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409923|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409924|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409925|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409926|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409927|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409928|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409929|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409930|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409931|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409932|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409933|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409934|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
410038|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
409935|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409936|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409937|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409938|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409939|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409940|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409941|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409942|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409943|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409944|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409945|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409946|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409947|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409948|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409949|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409950|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409951|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409952|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409953|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409954|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409955|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409956|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409957|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409958|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409959|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409960|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409961|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409962|NCT00972543|E2|Reported Event|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409963|NCT00972543|E1|Reported Event|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
409964|NCT00972530|B3|Baseline|Total|Total of all reporting groups
409965|NCT00972530|B2|Baseline|Immobilisation|48 hours postinjection rest
409966|NCT00972530|B1|Baseline|Activity|Normal activity without restrictions
409967|NCT00972530|P2|Participant Flow|Immobilisation|48 hours postinjection rest
409968|NCT00972530|P1|Participant Flow|Activity|Normal activity without restrictions
409969|NCT00972530|O2|Outcome|Immobilisation|48 hours postinjection rest
409970|NCT00972530|O1|Outcome|Activity|Normal activity without restrictions
409971|NCT00972530|E2|Reported Event|Immobilisation|48 hours postinjection rest
419207|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
409973|NCT00972504|B1|Baseline|Overall Study|Participants randomized to receive once daily GSK1004723 1000 µg nasal spray solution for 3 days or oral tablet of GSK835726 10 mg or oral capsule of cetirizine 10 mg or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409974|NCT00972504|P1|Participant Flow|Overall Study|Participants randomized to receive once daily GSK1004723 (1000 micrograms [µg]) nasal spray solution for 3 days or oral tablet of GSK835726 (10 milligram [mg]) or oral capsule of cetirizine (10 mg) or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409975|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409976|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409977|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409978|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409979|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409980|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409981|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409982|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409983|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409984|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409985|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409986|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409987|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409988|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
410039|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410111|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
409989|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409990|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409991|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409992|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409993|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409994|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409995|NCT00972504|O4|Outcome|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409996|NCT00972504|O3|Outcome|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409997|NCT00972504|O2|Outcome|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409998|NCT00972504|O1|Outcome|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
409999|NCT00972504|E4|Reported Event|Cetirizine 10 mg Once Daily|Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
410000|NCT00972504|E3|Reported Event|GSK835726 10 mg Once Daily|Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
410001|NCT00972504|E2|Reported Event|GSK1004723 1000 µg Once Daily|Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
410002|NCT00972504|E1|Reported Event|Placebo|Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days.
410003|NCT00972478|B3|Baseline|Total|Total of all reporting groups
410004|NCT00972478|B2|Baseline|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410005|NCT00972478|B1|Baseline|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410040|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410041|NCT00972374|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
410006|NCT00972478|P2|Participant Flow|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410007|NCT00972478|P1|Participant Flow|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410008|NCT00972478|O2|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410009|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410010|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410011|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410012|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410013|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410014|NCT00972478|E2|Reported Event|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410015|NCT00972478|E1|Reported Event|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
410016|NCT00972439|B3|Baseline|Total|Total of all reporting groups
410017|NCT00972439|B2|Baseline|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
410018|NCT00972439|B1|Baseline|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
410019|NCT00972439|P2|Participant Flow|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
410020|NCT00972439|P1|Participant Flow|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
410021|NCT00972439|O2|Outcome|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
410022|NCT00972439|O1|Outcome|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
410023|NCT00972439|E2|Reported Event|Ovcon Fe®|Ovcon Fe® is an oral contraceptive that contains less progestin.
410024|NCT00972439|E1|Reported Event|Ortho-Novum® 1/35|Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
410025|NCT00972374|B4|Baseline|Total|Total of all reporting groups
410026|NCT00972374|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
410027|NCT00972374|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410028|NCT00972374|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410029|NCT00972374|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
410030|NCT00972374|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410031|NCT00972374|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410032|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
410033|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410034|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410035|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
410036|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
419208|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
410042|NCT00972374|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410043|NCT00972374|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
410044|NCT00972335|B1|Baseline|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
410045|NCT00972335|P1|Participant Flow|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
410046|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
410047|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
410048|NCT00972335|E1|Reported Event|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
410049|NCT00972322|B3|Baseline|Total|Total of all reporting groups
410050|NCT00972322|B2|Baseline|Placebo|Placebo to MK-8245, twice daily for 28 days
410051|NCT00972322|B1|Baseline|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
410052|NCT00972322|P2|Participant Flow|Placebo|Placebo to MK-8245, twice daily for 28 days
410053|NCT00972322|P1|Participant Flow|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
410054|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
410055|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
410056|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
410057|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
410058|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
410059|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
410060|NCT00972322|E2|Reported Event|Placebo|Placebo to MK-8245, twice daily for 28 days
410061|NCT00972322|E1|Reported Event|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
410062|NCT00972283|B3|Baseline|Total|Total of all reporting groups
410063|NCT00972283|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410064|NCT00972283|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410065|NCT00972283|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410066|NCT00972283|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410067|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410068|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410069|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410070|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410071|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410072|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410073|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410074|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410075|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410076|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410077|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410078|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410079|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410080|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410081|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410082|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410083|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410084|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410085|NCT00972283|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410086|NCT00972283|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
410087|NCT00972244|B6|Baseline|Total|Total of all reporting groups
410088|NCT00972244|B5|Baseline|Placebo|Placebo Comparator
410089|NCT00972244|B4|Baseline|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
410090|NCT00972244|B3|Baseline|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
410091|NCT00972244|B2|Baseline|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
410092|NCT00972244|B1|Baseline|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
410093|NCT00972244|P5|Participant Flow|Placebo|Placebo Comparator
410094|NCT00972244|P4|Participant Flow|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
410095|NCT00972244|P3|Participant Flow|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
410096|NCT00972244|P2|Participant Flow|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
410097|NCT00972244|P1|Participant Flow|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
410098|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
410099|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
410100|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
410101|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
410102|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
410103|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
410104|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
410105|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
410106|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
410107|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
410108|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
410109|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
410110|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
410112|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
410113|NCT00972244|E5|Reported Event|Placebo|Placebo Comparator
410114|NCT00972244|E4|Reported Event|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
410115|NCT00972244|E3|Reported Event|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
410116|NCT00972244|E2|Reported Event|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
410117|NCT00972244|E1|Reported Event|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
410118|NCT00972205|B1|Baseline|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
410119|NCT00972205|P1|Participant Flow|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
410120|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
410121|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
410122|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
410123|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
410124|NCT00972205|E1|Reported Event|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
410125|NCT00972153|B4|Baseline|Total|Total of all reporting groups
410126|NCT00972153|B3|Baseline|Device Deployed and Activated|
410127|NCT00972153|B2|Baseline|Device Attached, Not Activated|
410128|NCT00972153|B1|Baseline|No Device Used|
410129|NCT00972153|P3|Participant Flow|Device Deployed and Activated|
410130|NCT00972153|P2|Participant Flow|Device Attached, Not Activated|
410131|NCT00972153|P1|Participant Flow|No Device Used|
410132|NCT00972153|O3|Outcome|Device Deployed and Activated|
410133|NCT00972153|O2|Outcome|Device Attached, Not Activated|
410134|NCT00972153|O1|Outcome|No Device Used|
410135|NCT00972153|O3|Outcome|Device Deployed and Activated|
410136|NCT00972153|O2|Outcome|Device Attached, Not Activated|
410137|NCT00972153|O1|Outcome|No Device Used|
410138|NCT00972153|E3|Reported Event|Device Deployed and Activated|
410139|NCT00972153|E2|Reported Event|Device Attached, Not Activated|
410140|NCT00972153|E1|Reported Event|No Device Used|
410141|NCT00972088|B1|Baseline|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
410142|NCT00972088|P1|Participant Flow|a Single Arm Group, Patients With Ano Rectal Disease|patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease
410143|NCT00972088|O1|Outcome|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
410144|NCT00972088|E1|Reported Event|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
410145|NCT00972023|B1|Baseline|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
410146|NCT00972023|P1|Participant Flow|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
410147|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
410183|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
410184|NCT00971841|E1|Reported Event|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
410148|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
410149|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
410150|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
410151|NCT00972023|E1|Reported Event|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
410152|NCT00971997|B1|Baseline|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410153|NCT00971997|P1|Participant Flow|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410154|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410155|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410156|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410157|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410158|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410159|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410160|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410161|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410162|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410163|NCT00971997|O3|Outcome|Lispro 50/50 Three Times Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410164|NCT00971997|O2|Outcome|Lispro 50/50 Twice Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410165|NCT00971997|O1|Outcome|Lispro 50/50 Once Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410166|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410167|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410168|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410169|NCT00971997|E1|Reported Event|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
410170|NCT00971932|B1|Baseline|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410171|NCT00971932|P1|Participant Flow|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410207|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
410408|NCT00970814|P2|Participant Flow|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
410172|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410173|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410174|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410175|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410176|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410177|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410178|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410179|NCT00971932|E1|Reported Event|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
410180|NCT00971841|B1|Baseline|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original Study CA139-540 (NCT 00344552)and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest. One treatment course consisted of 49 days total.
410181|NCT00971841|P1|Participant Flow|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original study (100 mg/m^2, 80 mg/m^2, or 60 mg/m^2) and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consisted of 49 days total.
410182|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
410185|NCT00971789|B1|Baseline|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
410186|NCT00971789|P1|Participant Flow|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
410187|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
410188|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
410189|NCT00971789|E1|Reported Event|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
410190|NCT00971750|B1|Baseline|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
410191|NCT00971750|P1|Participant Flow|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
410192|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
410193|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
410194|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively during gastric bypass
410195|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
410196|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
410197|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
410198|NCT00971750|E1|Reported Event|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
410199|NCT00971633|B1|Baseline|All Participants|All randomized participants
410200|NCT00971633|P6|Participant Flow|U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet|U.S. tablet then U.K. tablet then OE U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally
410201|NCT00971633|P5|Participant Flow|U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet|U.K. tablet then OE U.K. tablet then U.S. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
410202|NCT00971633|P4|Participant Flow|OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet|OE U.K. tablet then U.S. tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
410203|NCT00971633|P3|Participant Flow|U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet|U.S. tablet then OE U.K. tablet then U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K ZOFRAN (ondansetron) taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
410204|NCT00971633|P2|Participant Flow|U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet|U.K. tablet then U.S. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally /Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally.
410205|NCT00971633|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet then United States (U.S.) tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally./Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally./Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
410206|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
410208|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
410209|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
410210|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
410211|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
410212|NCT00971633|E3|Reported Event|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
410213|NCT00971633|E2|Reported Event|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
410214|NCT00971633|E1|Reported Event|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
410215|NCT00971620|B3|Baseline|Total|Total of all reporting groups
410216|NCT00971620|B2|Baseline|Placebo/Saline|Saline intralesional injection
410217|NCT00971620|B1|Baseline|BTX-A|BTX-A intralesional injection
410218|NCT00971620|P2|Participant Flow|Placebo/Saline|Saline intralesional injection
410219|NCT00971620|P1|Participant Flow|BTX-A|BTX-A intralesional injection
410220|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410221|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410222|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410223|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410224|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410225|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410226|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410227|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410228|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410229|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410230|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410231|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410232|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410233|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410234|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410235|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410236|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410237|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410238|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410239|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410240|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410241|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410242|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410243|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410244|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
410245|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
410246|NCT00971620|E2|Reported Event|Placebo/Saline|Saline intralesional injection
410247|NCT00971620|E1|Reported Event|BTX-A|BTX-A intralesional injection
410248|NCT00971425|B3|Baseline|Total|Total of all reporting groups
410249|NCT00971425|B2|Baseline|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410250|NCT00971425|B1|Baseline|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410251|NCT00971425|P2|Participant Flow|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410252|NCT00971425|P1|Participant Flow|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410253|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410254|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410255|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410256|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410405|NCT00970814|B3|Baseline|Total|Total of all reporting groups
410257|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410258|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410259|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410260|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410261|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410262|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410263|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410264|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410265|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410266|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410267|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410268|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410269|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410270|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410271|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410272|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410273|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410274|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410275|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410276|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410277|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410278|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410279|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410280|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410281|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410282|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410283|NCT00971425|E2|Reported Event|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
410284|NCT00971425|E1|Reported Event|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
410285|NCT00971295|B1|Baseline|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
410286|NCT00971295|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B:~Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate~850 mg metformin hydrochloride, 1200 mg ESL"
410287|NCT00971295|P1|Participant Flow|Treatment Sequence A|"Treatment Sequence A:~Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period~850 mg metformin hydrochloride, 1200 mg ESL"
410288|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
410289|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
410290|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
410291|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
410292|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
410293|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
410294|NCT00971295|E2|Reported Event|Metformin|Metformin HCl 850 mg
410295|NCT00971295|E1|Reported Event|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
410296|NCT00971282|B1|Baseline|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
410297|NCT00971282|P1|Participant Flow|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
410298|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
410299|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
410300|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
410301|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
410302|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
410303|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
410304|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
410305|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
410306|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
410307|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
410308|NCT00971282|E2|Reported Event|Differin Alone|intra-individual comparison
410309|NCT00971282|E1|Reported Event|Cetaphil + Differin|intra-individual comparison
410310|NCT00971243|B6|Baseline|Total|Total of all reporting groups
410311|NCT00971243|B5|Baseline|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410312|NCT00971243|B4|Baseline|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410313|NCT00971243|B3|Baseline|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410314|NCT00971243|B2|Baseline|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410406|NCT00970814|B2|Baseline|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
410315|NCT00971243|B1|Baseline|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410316|NCT00971243|P5|Participant Flow|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410317|NCT00971243|P4|Participant Flow|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410318|NCT00971243|P3|Participant Flow|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410319|NCT00971243|P2|Participant Flow|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410320|NCT00971243|P1|Participant Flow|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410321|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410322|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410323|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410324|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410325|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410326|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410327|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410328|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410329|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410330|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
410331|NCT00971243|E5|Reported Event|Placebo+Met|Placebo plus Metformin
410332|NCT00971243|E4|Reported Event|Teneli 40 mg+Met|Teneligliptin 40mg plus Metformin
410333|NCT00971243|E3|Reported Event|Teneli 20 mg+Met|Teneligliptin 20mg plus Metformin
410334|NCT00971243|E2|Reported Event|Teneli 10 mg+Met|Teneligliptin 10mg plus Metformin
410335|NCT00971243|E1|Reported Event|Teneli 5mg+Met|Teneligliptin 5mg plus Metformin
410336|NCT00971204|B1|Baseline|Treatment With HeartLight|Treatment of PAF with HeartLight System PVI ablation
410337|NCT00971204|P1|Participant Flow|Treatment With EAS-AC|"Treatment of PAF with EAS-AC~CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation"
410338|NCT00971204|O1|Outcome|Treatment With HeartLight|"Treatment of PAF with HeartLight System~CardioFocus HeartLight Endoscopic Ablation System: PVI ablation"
410339|NCT00971204|E1|Reported Event|Treatment With HeartLight|Treatment of PAF with HeartLight
410340|NCT00971048|B5|Baseline|Total|Total of all reporting groups
410341|NCT00971048|B4|Baseline|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
410342|NCT00971048|B3|Baseline|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
410343|NCT00971048|B2|Baseline|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
410344|NCT00971048|B1|Baseline|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
410345|NCT00971048|P4|Participant Flow|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
410346|NCT00971048|P3|Participant Flow|HP828-101 Treating PU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
410347|NCT00971048|P2|Participant Flow|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU (3M Tegaderm Hydrogel)"
410348|NCT00971048|P1|Participant Flow|HP828-101 Treating DFU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
410349|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
410350|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
410351|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
410352|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
410353|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
410407|NCT00970814|B1|Baseline|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
410354|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
410355|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
410356|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
410357|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
410358|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
410359|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
410360|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
410361|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
410362|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
410363|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
410364|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
410365|NCT00971048|E4|Reported Event|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
410366|NCT00971048|E3|Reported Event|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
410367|NCT00971048|E2|Reported Event|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
410368|NCT00971048|E1|Reported Event|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
410369|NCT00970944|B3|Baseline|Total|Total of all reporting groups
410370|NCT00970944|B2|Baseline|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
410371|NCT00970944|B1|Baseline|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
410372|NCT00970944|P2|Participant Flow|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
410373|NCT00970944|P1|Participant Flow|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
410374|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
410375|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
410376|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the study drug.
410377|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
410378|NCT00970944|E2|Reported Event|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
410379|NCT00970944|E1|Reported Event|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
410380|NCT00970853|B3|Baseline|Total|Total of all reporting groups
410381|NCT00970853|B2|Baseline|MOM Program Home Visiting|Mixed professional support home visiting program.
410382|NCT00970853|B1|Baseline|Control|Control group
410383|NCT00970853|P2|Participant Flow|MOM Program Home Visiting|Mixed professional support home visiting program.
410384|NCT00970853|P1|Participant Flow|Control|Control group
410385|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410386|NCT00970853|O1|Outcome|Control|Control group
410387|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410388|NCT00970853|O1|Outcome|Control|Control group
410389|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410390|NCT00970853|O1|Outcome|Control|Control group
410391|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410392|NCT00970853|O1|Outcome|Control|Control group
410393|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410394|NCT00970853|O1|Outcome|Control|Control group
410395|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410396|NCT00970853|O1|Outcome|Control|Control group
410397|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410398|NCT00970853|O1|Outcome|Control|Control group
410399|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410400|NCT00970853|O1|Outcome|Control|Control group
410401|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
410402|NCT00970853|O1|Outcome|Control|Control group
410403|NCT00970853|E2|Reported Event|MOM Program Home Visiting|Mixed professional support home visiting program.
410404|NCT00970853|E1|Reported Event|Control|Control group
410409|NCT00970814|P1|Participant Flow|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
410410|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
410411|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
410412|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
410413|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
410414|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
410415|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
410416|NCT00970814|E2|Reported Event|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
410417|NCT00970814|E1|Reported Event|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
410418|NCT00970736|B1|Baseline|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
410419|NCT00970736|P1|Participant Flow|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
410420|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
410421|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
410422|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
410423|NCT00970736|E1|Reported Event|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
410424|NCT00970684|B1|Baseline|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
410425|NCT00970684|P1|Participant Flow|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
410426|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
410427|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
410428|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
410429|NCT00970684|E1|Reported Event|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
410430|NCT00970632|B4|Baseline|Total|Total of all reporting groups
410431|NCT00970632|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410432|NCT00970632|B2|Baseline|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410433|NCT00970632|B1|Baseline|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410434|NCT00970632|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410435|NCT00970632|P2|Participant Flow|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410436|NCT00970632|P1|Participant Flow|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410437|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410438|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410439|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410440|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410441|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410442|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410443|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410444|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410445|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410446|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410447|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410448|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410449|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410450|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410451|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410452|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410453|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410454|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410455|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410456|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410457|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410458|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410459|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410460|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410461|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410462|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
411324|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
410463|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410464|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410465|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410466|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410467|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410468|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410469|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410470|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410471|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410472|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410473|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410474|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410475|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410476|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410477|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410478|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410479|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410480|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410481|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410482|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410483|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410484|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410485|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410486|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410487|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410488|NCT00970632|E3|Reported Event|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
410489|NCT00970632|E2|Reported Event|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
410490|NCT00970632|E1|Reported Event|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
410491|NCT00970606|B3|Baseline|Total|Total of all reporting groups
410492|NCT00970606|B2|Baseline|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
410493|NCT00970606|B1|Baseline|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
410494|NCT00970606|P2|Participant Flow|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
410495|NCT00970606|P1|Participant Flow|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
410496|NCT00970606|O2|Outcome|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
410497|NCT00970606|O1|Outcome|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
410498|NCT00970606|E2|Reported Event|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
410499|NCT00970606|E1|Reported Event|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
410500|NCT00970502|B1|Baseline|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
410501|NCT00970502|P1|Participant Flow|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
410502|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|Recommended dose of celecoxib was 400mg
410503|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
410504|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
410505|NCT00970502|O3|Outcome|Celecoxib 600mg|Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
410506|NCT00970502|O2|Outcome|Celecoxib 400mg|Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
410507|NCT00970502|O1|Outcome|Celecoxib 200mg|Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
410508|NCT00970502|E1|Reported Event|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
410509|NCT00970489|B3|Baseline|Total|Total of all reporting groups
410510|NCT00970489|B2|Baseline|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
410511|NCT00970489|B1|Baseline|Olive Oil Capsule|Placebo : Olive Oil capsules
410512|NCT00970489|P2|Participant Flow|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
410513|NCT00970489|P1|Participant Flow|Olive Oil Capsule|"Placebo : Olive Oil capsules All patients were randomized to receive n-3 Polyunsaturated fatty acids (PUFA) or matched placebo in equal numbers using computer-generated numbers, stratified by medical center.~Treatment: Either oral n-3 PUFA (1 g capsules, each containing ~850 mg of EPA+DHA) or matching placebo (olive oil, 1 g capsules).~Total loading dose = 8 g over 2 to 4 days pre-op, followed by 2 g/d post-op until hospital discharge or until post-op day 10, whichever sooner."
410514|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
410515|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
410516|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
410517|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
410518|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
410519|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
410520|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
410521|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
410522|NCT00970489|E2|Reported Event|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
410523|NCT00970489|E1|Reported Event|Olive Oil Capsule|Placebo : Olive Oil capsules
410524|NCT00970359|B1|Baseline|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
410525|NCT00970359|P1|Participant Flow|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
410526|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
410548|NCT00970320|E3|Reported Event|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
419209|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
410527|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
410528|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
410529|NCT00970359|E1|Reported Event|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
410530|NCT00970320|B6|Baseline|Total|Total of all reporting groups
410531|NCT00970320|B5|Baseline|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
410532|NCT00970320|B4|Baseline|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410533|NCT00970320|B3|Baseline|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
410534|NCT00970320|B2|Baseline|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410535|NCT00970320|B1|Baseline|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
410536|NCT00970320|P5|Participant Flow|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
410537|NCT00970320|P4|Participant Flow|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410538|NCT00970320|P3|Participant Flow|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
410539|NCT00970320|P2|Participant Flow|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410540|NCT00970320|P1|Participant Flow|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
410541|NCT00970320|O5|Outcome|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
410542|NCT00970320|O4|Outcome|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410543|NCT00970320|O3|Outcome|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
410544|NCT00970320|O2|Outcome|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410545|NCT00970320|O1|Outcome|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
410546|NCT00970320|E5|Reported Event|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
410547|NCT00970320|E4|Reported Event|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410549|NCT00970320|E2|Reported Event|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
410550|NCT00970320|E1|Reported Event|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
410551|NCT00970307|B4|Baseline|Total|Total of all reporting groups
410552|NCT00970307|B3|Baseline|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410553|NCT00970307|B2|Baseline|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410554|NCT00970307|B1|Baseline|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410555|NCT00970307|P3|Participant Flow|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410556|NCT00970307|P2|Participant Flow|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410557|NCT00970307|P1|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410558|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410559|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410560|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410561|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410562|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410563|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410564|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410656|NCT00970268|B2|Baseline|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
410657|NCT00970268|B1|Baseline|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
410731|NCT00969540|O1|Outcome|Total Sleep With Placebo Mattress Cover|Total sleep with placebo mattress cover (minutes).
410565|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410566|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410567|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410568|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410569|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410570|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410571|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410572|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410573|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410574|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410575|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410576|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410577|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410578|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410579|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410658|NCT00970268|P2|Participant Flow|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
410580|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410581|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410582|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410583|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410584|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410585|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410586|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410587|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410588|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410589|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410590|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410591|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410592|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410593|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410594|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410659|NCT00970268|P1|Participant Flow|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
410595|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410596|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410597|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410598|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410599|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410600|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410601|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410602|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410603|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410604|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410605|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410606|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410607|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410608|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410609|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410685|NCT00969878|E2|Reported Event|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
410610|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410611|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410612|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410613|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410614|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410615|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410616|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410617|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410618|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410619|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410620|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410621|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410622|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410623|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410624|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410686|NCT00969878|E1|Reported Event|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
410625|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410626|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410627|NCT00970307|E3|Reported Event|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410628|NCT00970307|E2|Reported Event|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410629|NCT00970307|E1|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
410630|NCT00970294|B1|Baseline|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
410631|NCT00970294|P1|Participant Flow|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
410632|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
410633|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
410634|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
410635|NCT00970294|E1|Reported Event|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
410636|NCT00970281|B3|Baseline|Total|Total of all reporting groups
410637|NCT00970281|B2|Baseline|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410638|NCT00970281|B1|Baseline|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410639|NCT00970281|P2|Participant Flow|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410640|NCT00970281|P1|Participant Flow|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410641|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410642|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410643|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410644|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410645|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410646|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410647|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410648|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410649|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410650|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410651|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410652|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410653|NCT00970281|E2|Reported Event|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410654|NCT00970281|E1|Reported Event|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
410655|NCT00970268|B3|Baseline|Total|Total of all reporting groups
410660|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
410661|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
410662|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
410663|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
410664|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 microgram of Aclidinium bromide for 12 weeks in the lead-in study.
410665|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation, twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
410666|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
410667|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
410668|NCT00970268|E4|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment.
410669|NCT00970268|E3|Reported Event|Placebo to Aclidinium Bromide 400μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment
410670|NCT00970268|E2|Reported Event|Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg|Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment.
410671|NCT00970268|E1|Reported Event|Placebo to Aclidinium Bromide 200 μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment
410672|NCT00970216|B1|Baseline|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
410673|NCT00970216|P1|Participant Flow|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
410674|NCT00970216|O1|Outcome|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
410675|NCT00970216|E1|Reported Event|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
410676|NCT00969878|B3|Baseline|Total|Total of all reporting groups
410677|NCT00969878|B2|Baseline|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
410678|NCT00969878|B1|Baseline|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
410679|NCT00969878|P2|Participant Flow|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
410680|NCT00969878|P1|Participant Flow|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
410681|NCT00969878|O2|Outcome|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
410682|NCT00969878|O1|Outcome|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
410683|NCT00969878|O2|Outcome|TA-CD Vaccination|The group randomized to receive the active medication, received the actual TA-CD vaccination at preset intervals as specified in the approved protocol.
410684|NCT00969878|O1|Outcome|Placebo Injection|A saline injection to mimic the active medication is administered to the Placebo group.
410687|NCT00969709|B5|Baseline|Total|Total of all reporting groups
410688|NCT00969709|B4|Baseline|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410689|NCT00969709|B3|Baseline|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410690|NCT00969709|B2|Baseline|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410691|NCT00969709|B1|Baseline|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
410692|NCT00969709|P4|Participant Flow|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
410693|NCT00969709|P3|Participant Flow|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
410694|NCT00969709|P2|Participant Flow|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
410695|NCT00969709|P1|Participant Flow|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
410696|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410697|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410698|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410699|NCT00969709|O1|Outcome|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
410700|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
410701|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
410702|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
410703|NCT00969709|O1|Outcome|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
410704|NCT00969709|E4|Reported Event|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410705|NCT00969709|E3|Reported Event|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
410706|NCT00969709|E2|Reported Event|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER, low dose, oral administration, once daily for 8 weeks.
410707|NCT00969709|E1|Reported Event|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks.
410708|NCT00969618|B1|Baseline|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410709|NCT00969618|P1|Participant Flow|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410710|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410711|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410712|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410713|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410714|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410715|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410716|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410717|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410718|NCT00969618|E1|Reported Event|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
410719|NCT00969540|B3|Baseline|Total|Total of all reporting groups
410720|NCT00969540|B2|Baseline|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days.
410721|NCT00969540|B1|Baseline|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days.
410722|NCT00969540|P2|Participant Flow|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
410723|NCT00969540|P1|Participant Flow|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days.
410724|NCT00969540|O2|Outcome|Sleep Latency With Active Mattress Cover|Sleep latency with active mattress cover (minutes).
410725|NCT00969540|O1|Outcome|Sleep Latency With Placebo Mattress Cover|Sleep latency with placebo mattress cover (minutes).
410726|NCT00969540|O2|Outcome|Sleep Efficiency With Active Mattress Cover|Sleep efficiency with active mattress cover.
410727|NCT00969540|O1|Outcome|Sleep Efficiency With Placebo Mattress Cover|Sleep efficiency with placebo mattress cover.
410728|NCT00969540|O2|Outcome|Nocturnal Awakenings With Active Mattress Cover|Number of nocturnal awakenings with active mattress cover.
410729|NCT00969540|O1|Outcome|Nocturnal Awakenings With Placebo Mattress Cover|Number of nocturnal awakenings with placebo mattress cover.
410730|NCT00969540|O2|Outcome|Total Sleep With Active Mattress Cover|Total sleep with active mattress cover (minutes).
410732|NCT00969540|O2|Outcome|Nighttime Wake Time With Active Mattress Cover|Nighttime wake time after sleep onset with active mattress cover.
410733|NCT00969540|O1|Outcome|Nighttime Wake Time With Placebo Mattress Cover|Nighttime wake time after sleep onset with placebo mattress cover.
410734|NCT00969540|O4|Outcome|Mean CGI Sleep Scores With Active Mattress Cover.|Mean Clinical Global Impression sleep scores with active mattress cover.
410735|NCT00969540|O3|Outcome|Mean CGI Sleep Scores With Placebo Mattress Cover.|Mean Clinical Global Impression sleep scores with placebo mattress cover.
410736|NCT00969540|O2|Outcome|Mean CGI Pain Scores With Active Mattress Cover.|Mean Clinical Global Impression pain scores with active mattress cover.
410737|NCT00969540|O1|Outcome|Mean CGI Pain Scores With Placebo Mattress Cover.|Mean Clinical Global Impression pain scores with placebo mattress cover.
410738|NCT00969540|E2|Reported Event|Active Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the active mattress cover for 14 days, followed by the placebo mattress cover for 14 days after a 7 day wash out period.
410739|NCT00969540|E1|Reported Event|Placebo Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the placebo mattress cover for 14 days, followed by the active mattress cover for 14 days after a 7 day wash out period.
410740|NCT00969501|B1|Baseline|EUFLEXXA|ACTIVE CONTROL
410741|NCT00969501|P1|Participant Flow|EUFLEXXA|All subjects received three injections (one each, in weeks 0 [baseline], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone).
410742|NCT00969501|O1|Outcome|EUFLEXXA|ACTIVE CONTROL
410743|NCT00969501|E1|Reported Event|EUFLEXXA|ACTIVE CONTROL
410744|NCT00969436|B4|Baseline|Total|Total of all reporting groups
410745|NCT00969436|B3|Baseline|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410746|NCT00969436|B2|Baseline|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410747|NCT00969436|B1|Baseline|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410748|NCT00969436|P3|Participant Flow|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410749|NCT00969436|P2|Participant Flow|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410750|NCT00969436|P1|Participant Flow|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410751|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410752|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410753|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410754|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410755|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410756|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410757|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410758|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410759|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410760|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410761|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410762|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410763|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410764|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410765|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410930|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
410766|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410767|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410768|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410769|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410770|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410771|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410772|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410773|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410774|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410775|NCT00969436|O3|Outcome|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410776|NCT00969436|O2|Outcome|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410777|NCT00969436|O1|Outcome|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410778|NCT00969436|E3|Reported Event|Control Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
410779|NCT00969436|E2|Reported Event|Priorix/ Priorix-Tetra Group|Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
410780|NCT00969436|E1|Reported Event|Priorix-Tetra Group|Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
410781|NCT00969280|B3|Baseline|Total|Total of all reporting groups
410782|NCT00969280|B2|Baseline|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
410783|NCT00969280|B1|Baseline|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
410784|NCT00969280|P2|Participant Flow|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
410785|NCT00969280|P1|Participant Flow|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
410786|NCT00969280|O2|Outcome|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
410787|NCT00969280|O1|Outcome|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
410931|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410788|NCT00969280|E2|Reported Event|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
410789|NCT00969280|E1|Reported Event|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
410790|NCT00969228|B3|Baseline|Total|Total of all reporting groups
410791|NCT00969228|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410792|NCT00969228|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410793|NCT00969228|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410794|NCT00969228|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410795|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410796|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410797|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410798|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410799|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410800|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410801|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410802|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410803|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410804|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410805|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410806|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410807|NCT00969228|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
410808|NCT00969228|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
410809|NCT00969150|B3|Baseline|Total|Total of all reporting groups
410810|NCT00969150|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
410811|NCT00969150|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
410812|NCT00969150|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
410813|NCT00969150|P1|Participant Flow|Placebo|Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.
410814|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
410815|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
410816|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
410817|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
410818|NCT00969150|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
410819|NCT00969150|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
410820|NCT00969124|B1|Baseline|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
410821|NCT00969124|P1|Participant Flow|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
410822|NCT00969124|O1|Outcome|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
410823|NCT00969124|O1|Outcome|Third Eye Retroscope|"All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.~Third Eye Retroscope: Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy"
410824|NCT00969124|O1|Outcome|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
410825|NCT00969124|E1|Reported Event|Third Eye Retroscope|All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
410826|NCT00968981|B4|Baseline|Total|Total of all reporting groups
411320|NCT00967473|B1|Baseline|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
410827|NCT00968981|B3|Baseline|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410828|NCT00968981|B2|Baseline|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410829|NCT00968981|B1|Baseline|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410830|NCT00968981|P3|Participant Flow|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once weekly (QW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410831|NCT00968981|P2|Participant Flow|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule three times weekly (TIW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410832|NCT00968981|P1|Participant Flow|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once daily (QD) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410833|NCT00968981|O1|Outcome|GDC-0449 150 mg: All Participants|All participants received single dose of GDC-0449 150 mg capsule orally on Day 1.
410834|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410835|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410836|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410837|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410838|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410839|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410840|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410841|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410842|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410843|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410844|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410845|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410846|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410847|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410848|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC­0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410849|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410850|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410851|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410852|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410853|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410854|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410932|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410855|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410856|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410857|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410858|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410859|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410860|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410861|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410862|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410863|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410864|NCT00968981|E3|Reported Event|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
410865|NCT00968981|E2|Reported Event|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
410866|NCT00968981|E1|Reported Event|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
410867|NCT00968890|B3|Baseline|Total|Total of all reporting groups
410868|NCT00968890|B2|Baseline|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410869|NCT00968890|B1|Baseline|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410870|NCT00968890|P2|Participant Flow|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410871|NCT00968890|P1|Participant Flow|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410872|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410873|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410874|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410875|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410876|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410877|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410878|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410879|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410880|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
419210|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
410881|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410882|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410883|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410884|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410885|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410886|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410887|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410888|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410889|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410890|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410891|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410892|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410893|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410894|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410895|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410896|NCT00968890|E2|Reported Event|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
410897|NCT00968890|E1|Reported Event|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
410898|NCT00968864|B1|Baseline|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410899|NCT00968864|P1|Participant Flow|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410900|NCT00968864|O2|Outcome|Matched Unrelated Donor Cohort|
410901|NCT00968864|O1|Outcome|Mismatched Related Donor Cohort|
410902|NCT00968864|O3|Outcome|Matched Unrelated Donor Cohort|Number of recipients alive following bone marrow transplant for non-malignant disease.
410903|NCT00968864|O2|Outcome|Mismatched Related Donor: Non-malignant Disease|Number of recipients alive following bone marrow transplant for non-malignant disease.
410904|NCT00968864|O1|Outcome|Mismatched Related Donor Cohort: Malignant Disease|Number of recipients alive following bone marrow transplant for malignant disease.
410933|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
410905|NCT00968864|O1|Outcome|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410906|NCT00968864|O1|Outcome|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410907|NCT00968864|O1|Outcome|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410908|NCT00968864|O1|Outcome|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410909|NCT00968864|O1|Outcome|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410910|NCT00968864|O2|Outcome|Matched Unrelated Donor Cohort|
410911|NCT00968864|O1|Outcome|Mismatched Related Donor Cohort|
410912|NCT00968864|O1|Outcome|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410913|NCT00968864|E1|Reported Event|T Cell Depletion Using CliniMACS®|"Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.~CliniMACS® (T cell depletion): Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells."
410914|NCT00968838|B3|Baseline|Total|Total of all reporting groups
410915|NCT00968838|B2|Baseline|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410916|NCT00968838|B1|Baseline|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410917|NCT00968838|P2|Participant Flow|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410918|NCT00968838|P1|Participant Flow|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410919|NCT00968838|O2|Outcome|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410920|NCT00968838|O1|Outcome|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410921|NCT00968838|E2|Reported Event|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410922|NCT00968838|E1|Reported Event|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
410923|NCT00968812|B4|Baseline|Total|Total of all reporting groups
410924|NCT00968812|B3|Baseline|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
410925|NCT00968812|B2|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410926|NCT00968812|B1|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410927|NCT00968812|P3|Participant Flow|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
410928|NCT00968812|P2|Participant Flow|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410929|NCT00968812|P1|Participant Flow|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410934|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410935|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410936|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
410937|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410938|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410939|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
410940|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410941|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
410942|NCT00968812|E6|Reported Event|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
410943|NCT00968812|E5|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
410944|NCT00968812|E4|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
410945|NCT00968812|E3|Reported Event|Glimepiride: Baseline to Week 52|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
410946|NCT00968812|E2|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
410947|NCT00968812|E1|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
410948|NCT00968799|B1|Baseline|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
410949|NCT00968799|P1|Participant Flow|HIPEC|"Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)~Tumor nodules are removed surgically. If necessary infested organs like colon are resected (=cytoreduction).~To destroy remaining tumor cells or invisible nodules the peritoneum is prefused with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l).~If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin).~Perfusion is performed with the open or Coliseum technique for 90 min."
410950|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
410951|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
410952|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
410953|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
410954|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
410955|NCT00968799|E1|Reported Event|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
410956|NCT00968708|B3|Baseline|Total|Total of all reporting groups
410957|NCT00968708|B2|Baseline|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
410958|NCT00968708|B1|Baseline|Placebo|Alogliptin placebo matching tablets, orally, once daily.
410959|NCT00968708|P2|Participant Flow|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
410960|NCT00968708|P1|Participant Flow|Placebo|Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
410961|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
410962|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
410963|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
410964|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
412149|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
410965|NCT00968708|E2|Reported Event|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
410966|NCT00968708|E1|Reported Event|Placebo|Alogliptin placebo matching tablets, orally, once daily.
410967|NCT00968669|B5|Baseline|Total|Total of all reporting groups
410968|NCT00968669|B4|Baseline|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410969|NCT00968669|B3|Baseline|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410970|NCT00968669|B2|Baseline|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410971|NCT00968669|B1|Baseline|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
410972|NCT00968669|P4|Participant Flow|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410973|NCT00968669|P3|Participant Flow|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410974|NCT00968669|P2|Participant Flow|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410975|NCT00968669|P1|Participant Flow|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
410976|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410977|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410978|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410979|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
410980|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410981|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410982|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410983|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
410984|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410985|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410986|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410987|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
410988|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410989|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410990|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410991|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
410992|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410993|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410994|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410995|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
410996|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410997|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410998|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
410999|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411000|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411001|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411002|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411003|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411004|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411005|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411006|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411007|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411008|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411009|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411010|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411011|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
412150|NCT00965562|E3|Reported Event|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
411012|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411013|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411014|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411015|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411016|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411017|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411018|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411019|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411020|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411021|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411022|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411023|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411024|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411025|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411026|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411027|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411028|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411029|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411030|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411031|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411032|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411033|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411034|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411035|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411036|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411037|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411038|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411039|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411040|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411041|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411042|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411043|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411044|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411045|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411046|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411047|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411048|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411049|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411050|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411051|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411052|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411053|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411054|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411055|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411056|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411057|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411058|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411059|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411060|NCT00968669|E4|Reported Event|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
419211|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
411061|NCT00968669|E3|Reported Event|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411062|NCT00968669|E2|Reported Event|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
411063|NCT00968669|E1|Reported Event|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
411064|NCT00968617|B1|Baseline|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411065|NCT00968617|P1|Participant Flow|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411066|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411067|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411068|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411069|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411070|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411071|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411072|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411073|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411074|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
411075|NCT00968617|E1|Reported Event|MK-2578|
411076|NCT00968539|B3|Baseline|Total|Total of all reporting groups
411077|NCT00968539|B2|Baseline|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411078|NCT00968539|B1|Baseline|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411079|NCT00968539|P2|Participant Flow|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411080|NCT00968539|P1|Participant Flow|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411081|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411082|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411083|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411084|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411085|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411086|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411087|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411088|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411089|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411090|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411091|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411092|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411093|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411094|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411321|NCT00967473|P1|Participant Flow|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
411322|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
411095|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411096|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411097|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411098|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411099|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411100|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411101|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411102|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411103|NCT00968539|O1|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411104|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411105|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411106|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411107|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411108|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411109|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411110|NCT00968539|O1|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411111|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411112|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411113|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411114|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411115|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411116|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411117|NCT00968539|O1|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411118|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411119|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411120|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411121|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411122|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411123|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411124|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411125|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411126|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411127|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411128|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411129|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411130|NCT00968539|O2|Outcome|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411131|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411132|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411133|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411134|NCT00968539|O1|Outcome|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411135|NCT00968539|E2|Reported Event|GSK2340269A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411136|NCT00968539|E1|Reported Event|GSK2340272A Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
411137|NCT00968253|B4|Baseline|Total|Total of all reporting groups
411138|NCT00968253|B3|Baseline|Phase II: MTD RAD001 + Combination Chemo|RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411139|NCT00968253|B2|Baseline|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411140|NCT00968253|B1|Baseline|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411141|NCT00968253|P3|Participant Flow|Phase II: MTD RAD001 + Combination Chemo|"RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
411191|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411142|NCT00968253|P2|Participant Flow|Phase I: RAD001 10 mg + Combination Chemo|"RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
411143|NCT00968253|P1|Participant Flow|Phase I: RAD001 5 mg + Combination Chemo|"Everolimus (RAD001) beginning oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
411144|NCT00968253|O3|Outcome|Phase II: MTD RAD001 + Combination Chemo|RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411145|NCT00968253|O2|Outcome|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411146|NCT00968253|O1|Outcome|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411147|NCT00968253|O3|Outcome|Phase II: MTD RAD001 + Combination Chemo|RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411148|NCT00968253|O2|Outcome|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411149|NCT00968253|O1|Outcome|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411150|NCT00968253|O3|Outcome|Phase II: MTD RAD001 + Combination Chemo|"RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Cytarabine (Ara-C) during Even Cycles. First chemo combo Hyper-CVAD = Cyclophosphamide 300 mg/m^2 intravenous (IV) every 12 hours x 6 doses on Days 1-3 (total dose 1800 mg/m2), Vincristine 2 mg IV on Day 4 & Day 11, Adriamycin (doxorubicin) 50 mg/m^2 IV over 24 hours Day 4, after last dose Cyclophosphamide, and Dexamethasone daily 40 mg IV or orally Days 1-4 & Days 11-14 with second Methotrexate 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 IV over 22 hours Day 1 & Ara-C 3 gm/m^2 IV every 12 hours for 4 doses Days 2, 3.~Days 1-3, Mesna: 600 mg/m^2 IV continuous infusion daily and Methylprednisone: 50 mg IV every 12 hours for 6 doses. G-CSF: 10 mcg/kg/day within 72 after completion of chemo until neutrophil recovery 1 x 10^9/L or higher."
411151|NCT00968253|O2|Outcome|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411152|NCT00968253|O1|Outcome|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411153|NCT00968253|E3|Reported Event|Phase II: MTD RAD001 + Combination Chemo|RAD001 MTD oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411154|NCT00968253|E2|Reported Event|Phase I: RAD001 10 mg + Combination Chemo|RAD001 oral dose 10 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411155|NCT00968253|E1|Reported Event|Phase I: RAD001 5 mg + Combination Chemo|RAD001 oral dose 5 mg every other day before chemo + two different chemotherapy combinations during alternating cycles, Hyper-CVAD on Odd Cycles and Methotrexate & Ara-C during Even Cycles.
411156|NCT00968227|B1|Baseline|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
411157|NCT00968227|P1|Participant Flow|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
411158|NCT00968227|O1|Outcome|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
411159|NCT00968227|O1|Outcome|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
411160|NCT00968227|E1|Reported Event|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
411161|NCT00968201|B3|Baseline|Total|Total of all reporting groups
411162|NCT00968201|B2|Baseline|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411163|NCT00968201|B1|Baseline|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411245|NCT00968149|E2|Reported Event|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411323|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
411164|NCT00968201|P3|Participant Flow|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
411165|NCT00968201|P2|Participant Flow|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411166|NCT00968201|P1|Participant Flow|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411167|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411168|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411169|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411170|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411171|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411172|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411173|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411174|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411175|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411176|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411177|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411308|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
411178|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411179|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411180|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411181|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411182|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411183|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411184|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411185|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411186|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411187|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411188|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411189|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411190|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411192|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411193|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411194|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411195|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411196|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411197|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
411198|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411199|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411200|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411201|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411202|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411203|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411204|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411205|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411206|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411207|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411208|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411209|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411210|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411211|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411212|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411213|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411214|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411215|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411216|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411217|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411218|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411219|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
411220|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411309|NCT00967551|E2|Reported Event|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
411221|NCT00968201|E3|Reported Event|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
411222|NCT00968201|E2|Reported Event|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
411223|NCT00968201|E1|Reported Event|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
411224|NCT00968149|B3|Baseline|Total|Total of all reporting groups
411225|NCT00968149|B2|Baseline|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411226|NCT00968149|B1|Baseline|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411227|NCT00968149|P2|Participant Flow|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411228|NCT00968149|P1|Participant Flow|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411229|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411230|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411231|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411232|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411233|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411234|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411235|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411236|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411237|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411238|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411239|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411240|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411241|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411242|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411243|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
411244|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411310|NCT00967551|E1|Reported Event|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
411246|NCT00968149|E1|Reported Event|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
411247|NCT00968071|B1|Baseline|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
411248|NCT00968071|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
411249|NCT00968071|O1|Outcome|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
411250|NCT00968071|E1|Reported Event|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
411251|NCT00968032|B1|Baseline|Nit-Occlud® PFO|
411252|NCT00968032|P1|Participant Flow|Nit-Occlud® PFO Implantation Group|Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device
411253|NCT00968032|O1|Outcome|Nit-Occlud® PFO|
411254|NCT00968032|E1|Reported Event|Nit-Occlud® PFO|
411255|NCT00968019|B1|Baseline|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411256|NCT00968019|P1|Participant Flow|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411257|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411258|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411259|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411260|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411261|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411262|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411263|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411264|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411265|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411266|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411267|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411268|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411269|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411270|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411271|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411272|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411273|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411274|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411275|NCT00968019|E1|Reported Event|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
411276|NCT00967993|B1|Baseline|KRX-0502|All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron
411277|NCT00967993|P1|Participant Flow|KRX-0502|"All patients initiated on study drug were started on a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients were titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels went below normal, there was a decrease in pills; if serum phosphorus levels went above normal, there was an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day was 12, or 12 g/day of ferric citrate."
411278|NCT00967993|O1|Outcome|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
411279|NCT00967993|E1|Reported Event|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
411280|NCT00967694|B1|Baseline|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
411281|NCT00967694|P1|Participant Flow|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
411282|NCT00967694|O1|Outcome|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline (prior to nitrous oxide administration) and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore one study arm, with each individual serving as their control for baseline (before nitrous oxide administration) and then intervention values of IOP measurement (during nitrous oxide administration), and then washout values of IOP (after breathing room air).
411311|NCT00967486|B3|Baseline|Total|Total of all reporting groups
411283|NCT00967694|E1|Reported Event|Nitrous Oxide Administration|20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
411284|NCT00967668|B4|Baseline|Total|Total of all reporting groups
411285|NCT00967668|B3|Baseline|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
411286|NCT00967668|B2|Baseline|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411287|NCT00967668|B1|Baseline|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411288|NCT00967668|P3|Participant Flow|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
411289|NCT00967668|P2|Participant Flow|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411290|NCT00967668|P1|Participant Flow|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411291|NCT00967668|O3|Outcome|Arm 3|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
411292|NCT00967668|O2|Outcome|Arm 2|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411312|NCT00967486|B2|Baseline|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
411313|NCT00967486|B1|Baseline|Routine Shunt|routine methods of CEA
411314|NCT00967486|P2|Participant Flow|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
411315|NCT00967486|P1|Participant Flow|Routine Shunt|Routine method of CEA
411316|NCT00967486|O2|Outcome|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
411317|NCT00967486|O1|Outcome|Routine Shunt|routine methods of CEA
411293|NCT00967668|O1|Outcome|Arm 1|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411294|NCT00967668|O3|Outcome|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
411295|NCT00967668|O2|Outcome|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411296|NCT00967668|O1|Outcome|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411297|NCT00967668|E3|Reported Event|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
411298|NCT00967668|E2|Reported Event|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411299|NCT00967668|E1|Reported Event|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
411300|NCT00967551|B3|Baseline|Total|Total of all reporting groups
411301|NCT00967551|B2|Baseline|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
411302|NCT00967551|B1|Baseline|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
411303|NCT00967551|P2|Participant Flow|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
411304|NCT00967551|P1|Participant Flow|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
411305|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
411306|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
411307|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
411318|NCT00967486|E2|Reported Event|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
411325|NCT00967473|E1|Reported Event|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
411326|NCT00967447|B1|Baseline|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
411327|NCT00967447|P1|Participant Flow|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
411328|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
411329|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
411330|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
411331|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
411332|NCT00967447|E1|Reported Event|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
411333|NCT00967330|B3|Baseline|Total|Total of all reporting groups
411334|NCT00967330|B2|Baseline|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411335|NCT00967330|B1|Baseline|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411336|NCT00967330|P2|Participant Flow|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411337|NCT00967330|P1|Participant Flow|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411338|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411339|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411340|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411341|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411342|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411343|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411344|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411345|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411346|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411347|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411348|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411349|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411350|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411392|NCT00967226|O1|Outcome|Overall Number of Adverse Events in Propranolol|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
411393|NCT00967226|O2|Outcome|Prednisolone|"A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
419212|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
411351|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411352|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411353|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411354|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411355|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411356|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411357|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411358|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411359|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411394|NCT00967226|O1|Outcome|Propranolol|A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)
411395|NCT00967226|E2|Reported Event|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 6 months or less"
411360|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
411361|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411362|NCT00967330|E2|Reported Event|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator or and, if eligible.
411363|NCT00967330|E1|Reported Event|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
411364|NCT00967226|B3|Baseline|Total|Total of all reporting groups
411365|NCT00967226|B2|Baseline|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
411366|NCT00967226|B1|Baseline|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)"
411367|NCT00967226|P2|Participant Flow|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID 4-6 months"
411368|NCT00967226|P1|Participant Flow|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.67 mg/kg p.o. TID 4-6 months"
411369|NCT00967226|O2|Outcome|Constitutional AEs Prednisolone|Number of Participants experiencing Constitutional AEs
411370|NCT00967226|O1|Outcome|Constitutional AEs Propranolol|Number of Participants experiencing Constitutional AEs
411371|NCT00967226|O2|Outcome|Vascular AEs Prednisolone|Number of participants experiencing Vascular AEs
411372|NCT00967226|O1|Outcome|Vascular AEs Propranolol|Number of participants experiencing Vascular AEs
411373|NCT00967226|O2|Outcome|Metabolic/Laboratory AEs Prednisolone|Number of participants experiencing Metabolic or Laboratory AEs in each study arm.
411374|NCT00967226|O1|Outcome|Metabolic/Laboratory AEs Propranolol|Number of participants experiencing Metabolic or Laboratory AEs.
411375|NCT00967226|O2|Outcome|Infectious AEs Prednisolone|Number of participants experiencing Infectious AEs
411376|NCT00967226|O1|Outcome|Infectious AEs Propranolol|Number of participants experiencing Infectious AEs
411377|NCT00967226|O2|Outcome|Gastrointestinal AEs Prednisolone|Number of Participants experiencing Gastrointestinal AEs
411378|NCT00967226|O1|Outcome|Gastrointestinal AEs Propranolol|Number of Participants experiencing Gastrointestinal AEs
411379|NCT00967226|O2|Outcome|Endocrinologic AEs Prednisolone|Number of participants experiencing Endocrinologic AEs.
411380|NCT00967226|O1|Outcome|Endocrine AEs Propranolol|Number of participants experiencing Endocrinologic AEs.
411381|NCT00967226|O2|Outcome|Dermatologic AEs Prednisolone|Number of participants experiencing Dermatologic AEs
411382|NCT00967226|O1|Outcome|Dermatologic AEs Propranolol|Number of participants experiencing Dermatologic AEs
411383|NCT00967226|O2|Outcome|Allergy/Immunology Events Prednisolone|Adverse events in allergy/immunology in prednisolone treated participants
411384|NCT00967226|O1|Outcome|Allergy/Immunology Events Propranolol|Adverse events in allergy/immunology in propranolol treated participants
411385|NCT00967226|O2|Outcome|Pulmonary/Respiratory AEs Prednisolone|Number of participants experiencing pulmonary/respiratory AEs
411386|NCT00967226|O1|Outcome|Pulmonary/Respiratory AEs Propranolol|Number of participants experiencing pulmonary/respiratory AEs
411387|NCT00967226|O2|Outcome|Growth/Development AEs Prednisolone|Number of participants experiencing Growth/Development AEs
411388|NCT00967226|O1|Outcome|Growth/Developoment AEs Propranolol|Number of participants experiencing Growth/Development AEs
411389|NCT00967226|O2|Outcome|Number of Serious Adverse Events in Prednisolone|Serious adverse events in prednisolone treated participants
411390|NCT00967226|O1|Outcome|Number of Serious Adverse Events in Propranolol|Serious adverse events in propranolol treated participants.
411391|NCT00967226|O2|Outcome|Overall Number of Adverse Events in Prednisolone|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
419213|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
411396|NCT00967226|E1|Reported Event|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.5 mg/kg p.o. QID 6 months or less"
411397|NCT00967044|B1|Baseline|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by participants), three times per week.~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
411398|NCT00967044|P1|Participant Flow|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
411399|NCT00967044|O1|Outcome|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
411400|NCT00967044|E1|Reported Event|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
411401|NCT00967018|B1|Baseline|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
411402|NCT00967018|P1|Participant Flow|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
411403|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
411404|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
411405|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
411406|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
411407|NCT00967018|E1|Reported Event|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
411408|NCT00967005|B3|Baseline|Total|Total of all reporting groups
411409|NCT00967005|B2|Baseline|Sugar Pill|Sugar Pill: placebo control
411410|NCT00967005|B1|Baseline|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411411|NCT00967005|P2|Participant Flow|Sugar Pill|Sugar Pill: placebo control
411412|NCT00967005|P1|Participant Flow|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411413|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
419214|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
411414|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411415|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411416|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411417|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411418|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411419|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411420|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411421|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411422|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411423|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411424|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411425|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411426|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411427|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411428|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411429|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411430|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411431|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411432|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411433|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411434|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411435|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411436|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411437|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411438|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411439|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411440|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411441|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411442|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411443|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411444|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411445|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411446|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411447|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411448|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411449|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411450|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411451|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411452|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411453|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411454|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411455|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411456|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411457|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411458|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411459|NCT00967005|O2|Outcome|Sugar Pill|Sugar Pill: placebo control
411460|NCT00967005|O1|Outcome|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411461|NCT00967005|E2|Reported Event|Sugar Pill|Sugar Pill: placebo control
411462|NCT00967005|E1|Reported Event|N Acetyl Cysteine|"The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.~N Acetyl Cysteine: N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks"
411463|NCT00966992|B3|Baseline|Total|Total of all reporting groups
411464|NCT00966992|B2|Baseline|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
411465|NCT00966992|B1|Baseline|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411466|NCT00966992|P2|Participant Flow|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
411467|NCT00966992|P1|Participant Flow|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411468|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
411469|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411470|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
411471|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411472|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
411473|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411513|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411514|NCT00966940|E2|Reported Event|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411474|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
411475|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411476|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
411477|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411478|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
411479|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411480|NCT00966992|E2|Reported Event|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
411481|NCT00966992|E1|Reported Event|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
411482|NCT00966953|B5|Baseline|Total|Total of all reporting groups
411483|NCT00966953|B4|Baseline|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
411484|NCT00966953|B3|Baseline|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
411485|NCT00966953|B2|Baseline|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
411486|NCT00966953|B1|Baseline|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
411487|NCT00966953|P4|Participant Flow|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
411488|NCT00966953|P3|Participant Flow|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
411489|NCT00966953|P2|Participant Flow|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
411490|NCT00966953|P1|Participant Flow|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
411491|NCT00966953|O4|Outcome|Herbal Extract Toothpaste|Fluoride/Magnolol extract toothpaste
411492|NCT00966953|O3|Outcome|Herbal Extract Toothpaste|Fluoride/Honokiol extract toothpaste
411493|NCT00966953|O2|Outcome|Total/Whitening|Control toothpaste
411494|NCT00966953|O1|Outcome|Fluoride Only|Control toothopaste
411495|NCT00966940|B3|Baseline|Total|Total of all reporting groups
411496|NCT00966940|B2|Baseline|Tafluprost-to-travoprost|Tafluprost, then travoprost
411497|NCT00966940|B1|Baseline|Travoprost-to-tafluprost|Travoprost, then tafluprost
411498|NCT00966940|P2|Participant Flow|Tafluprost-to-travoprost|Tafluprost, then travoprost
411499|NCT00966940|P1|Participant Flow|Travoprost-to-tafluprost|Travoprost, then tafluprost
411500|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411501|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411502|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411503|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411504|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411505|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411506|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411507|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411508|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411509|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411510|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411511|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411512|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411515|NCT00966940|E1|Reported Event|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
411516|NCT00966875|B10|Baseline|Total|Total of all reporting groups
411517|NCT00966875|B9|Baseline|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411518|NCT00966875|B8|Baseline|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411519|NCT00966875|B7|Baseline|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411520|NCT00966875|B6|Baseline|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411521|NCT00966875|B5|Baseline|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411522|NCT00966875|B4|Baseline|30 mg LY2439821 [bDMARD-naive Population|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411523|NCT00966875|B3|Baseline|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411524|NCT00966875|B2|Baseline|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411525|NCT00966875|B1|Baseline|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411526|NCT00966875|P9|Participant Flow|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411527|NCT00966875|P8|Participant Flow|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411528|NCT00966875|P7|Participant Flow|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)]
411529|NCT00966875|P6|Participant Flow|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411530|NCT00966875|P5|Participant Flow|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411531|NCT00966875|P4|Participant Flow|30 mg LY2439821 [bDMARD-naive Population]|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411532|NCT00966875|P3|Participant Flow|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411533|NCT00966875|P2|Participant Flow|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411534|NCT00966875|P1|Participant Flow|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
411535|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411536|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411537|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411538|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411539|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411540|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411541|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411542|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411543|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411544|NCT00966875|O8|Outcome|Part B: 160 mg LY2439821 (bDMARD-naive and TNFα-IR Population)|160 mg LY2439821 administered subcutaneously at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60, in Part B.
411545|NCT00966875|O7|Outcome|Part A: 180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411546|NCT00966875|O6|Outcome|Part A: 80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411547|NCT00966875|O5|Outcome|Part A: 180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411548|NCT00966875|O4|Outcome|Part A: 80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411549|NCT00966875|O3|Outcome|Part A: 30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411550|NCT00966875|O2|Outcome|Part A: 10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411551|NCT00966875|O1|Outcome|Part A: 3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411552|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411553|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411554|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411555|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411556|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411557|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411558|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411559|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411560|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411561|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411562|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411563|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411564|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411565|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411566|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411567|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411568|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411569|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411570|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
412151|NCT00965562|E2|Reported Event|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
411571|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411572|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411573|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411574|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411575|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411576|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411577|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411578|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411579|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411580|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411581|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411582|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411583|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411584|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411585|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411586|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411587|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411588|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411589|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411590|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411591|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411592|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411593|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411594|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411595|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411596|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
412152|NCT00965562|E1|Reported Event|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
411597|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411598|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411599|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411600|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411601|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411602|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411603|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411604|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411605|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411606|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411607|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411608|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411609|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411610|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411611|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411612|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411613|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411614|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411615|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411616|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411617|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411618|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411619|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411620|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411621|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411622|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411623|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411624|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411625|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411626|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411627|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411628|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411629|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
412483|NCT00964431|E2|Reported Event|Indomethacin Test (Upper Dose)|Single dose
411630|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411631|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411632|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411633|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411634|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411635|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411636|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411637|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411638|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411639|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411640|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411641|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411642|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411643|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411644|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411645|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411646|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411647|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411648|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411649|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411650|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411651|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411652|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411653|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411654|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411655|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411656|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411657|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411658|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411659|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411660|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411661|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411662|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411663|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411664|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411665|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411666|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411667|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411668|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411669|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411670|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411671|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411672|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population])|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411673|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411674|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411675|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411676|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411677|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411678|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411679|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411680|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411681|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411682|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411683|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411684|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411685|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411686|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411687|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411688|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411689|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411690|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411691|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411692|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411693|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411694|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411695|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
412484|NCT00964431|E1|Reported Event|Indomethacin Test (Lower Dose)|
411696|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411697|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411698|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411699|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411700|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411701|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411702|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411703|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411704|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411705|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411706|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411707|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411708|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411709|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411710|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411711|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411712|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411713|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411714|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411715|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411716|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411717|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411718|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411719|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411720|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411721|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411722|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411723|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411724|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411725|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411726|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
412485|NCT00964392|B3|Baseline|Total|Total of all reporting groups
411727|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411728|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411729|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411730|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411731|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411732|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411733|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411734|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411735|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411736|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411737|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411738|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411739|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411740|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411741|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411742|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411743|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411744|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411745|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411746|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411747|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411748|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411749|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411750|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411751|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411752|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411753|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411754|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411755|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411756|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411757|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411825|NCT00966875|O3|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411758|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411759|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411760|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411761|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411762|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411763|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411764|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411765|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411766|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411767|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411768|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411769|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411770|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411771|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411772|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411773|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411774|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411775|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411776|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411777|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411778|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411779|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411780|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411781|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411782|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411783|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411784|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 milligram (mg) LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411785|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411786|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411787|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411788|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411789|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411790|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
413750|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
411791|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411792|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411793|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411794|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411795|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411796|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411797|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411798|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411799|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411800|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411801|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411802|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411803|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411804|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821(TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411805|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821(TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411806|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411807|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411808|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821(bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411809|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821(bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411810|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821(bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411811|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821(bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411812|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411813|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411814|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411815|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411816|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411817|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411818|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411819|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411820|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411821|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411822|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411823|NCT00966875|O1|Outcome|3 mg to 180 mg (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411824|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
412437|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
411826|NCT00966875|O2|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411827|NCT00966875|O1|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411828|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411829|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411830|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411831|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411832|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411833|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
411834|NCT00966875|E18|Reported Event|Placebo/160 mg LY2439821 (TNFa-IR Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411835|NCT00966875|E17|Reported Event|180 mg/160 mg LY2439821 (TNFa-IR Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411836|NCT00966875|E16|Reported Event|80 mg/160 mg LY2439821 (TNFa-IR Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411837|NCT00966875|E15|Reported Event|Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411838|NCT00966875|E14|Reported Event|180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411839|NCT00966875|E13|Reported Event|80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411840|NCT00966875|E12|Reported Event|30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411841|NCT00966875|E11|Reported Event|10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411842|NCT00966875|E10|Reported Event|3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411843|NCT00966875|E9|Reported Event|Placebo (TNFa-IR Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411844|NCT00966875|E8|Reported Event|180 mg LY2439821 (TNFa-IR Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411845|NCT00966875|E7|Reported Event|80 mg LY2439821 (TNFa-IR Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411846|NCT00966875|E6|Reported Event|Placebo (bDMARD-naive Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411847|NCT00966875|E5|Reported Event|180 mg LY2439821(bDMARD-naive Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411848|NCT00966875|E4|Reported Event|80 mg LY2439821 (bDMARD-naive Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411849|NCT00966875|E3|Reported Event|30 mg LY2439821 (bDMARD-naive Population) Part A|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411850|NCT00966875|E2|Reported Event|10 mg LY2439821 (bDMARD-naive Population) Part A|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411851|NCT00966875|E1|Reported Event|3 mg LY2439821 (bDMARD-naive Population) Part A|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
411852|NCT00966823|B1|Baseline|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411907|NCT00966355|P3|Participant Flow|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
412153|NCT00965523|B1|Baseline|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
411853|NCT00966823|P1|Participant Flow|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411854|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411855|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411856|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411857|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411858|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411859|NCT00966823|E1|Reported Event|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
411860|NCT00966654|B1|Baseline|All Study Participants|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
411861|NCT00966654|P1|Participant Flow|GLP-1|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.~OR~Placebo (saline)"
411862|NCT00966654|O2|Outcome|Saline|"Saline~Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
411863|NCT00966654|O1|Outcome|GLP-1|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
411864|NCT00966654|O2|Outcome|Saline|"Saline~Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
411865|NCT00966654|O1|Outcome|GLP-1|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
411866|NCT00966654|E2|Reported Event|Saline|"Saline~Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
411867|NCT00966654|E1|Reported Event|GLP-1|"GLP-1 (7-36) amide~GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours."
411868|NCT00966641|B1|Baseline|All Study Participants|All study participants who were enrolled in the study.
411869|NCT00966641|P2|Participant Flow|Naproxen First, Then PL3100|"First Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen~(after 7-14 day washout period)~Second Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)"
411870|NCT00966641|P1|Participant Flow|PL3100 First, Then Naproxen|"First Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)~(after 7-14 day washout period)~Second Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen"
411871|NCT00966641|O2|Outcome|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
411872|NCT00966641|O1|Outcome|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
411873|NCT00966641|E2|Reported Event|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
411874|NCT00966641|E1|Reported Event|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
411875|NCT00966550|B3|Baseline|Total|Total of all reporting groups
411876|NCT00966550|B2|Baseline|Non-tomato First Then Tomato|"Non-tomato high fat test meal~Non-tomato test meal: non-tomato with High fat test meal"
411877|NCT00966550|B1|Baseline|Tomato First Then Non-tomato|"tomato High fat test meal~Tomato products: tomato with High fat test meal"
411878|NCT00966550|P2|Participant Flow|Non-tomato First Then Tomato|Non-tomato :High fat meal with non-tomato
411879|NCT00966550|P1|Participant Flow|Tomato First Then Non-tomato|Tomato :High fat meal with tomato
411880|NCT00966550|O2|Outcome|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
411881|NCT00966550|O1|Outcome|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
411882|NCT00966550|E2|Reported Event|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
411883|NCT00966550|E1|Reported Event|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
411884|NCT00966446|B4|Baseline|Total|Total of all reporting groups
411885|NCT00966446|B3|Baseline|No Intervention|Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages).
411908|NCT00966355|P2|Participant Flow|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
411886|NCT00966446|B2|Baseline|Supervised Decolonization|This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview.
411887|NCT00966446|B1|Baseline|Unsupervised Decolonization|"This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the no intervention group."
411888|NCT00966446|P3|Participant Flow|No Intervention|Households do not undergo active MRSA decolonization protocol
411889|NCT00966446|P2|Participant Flow|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
411890|NCT00966446|P1|Participant Flow|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
411891|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
411892|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
411893|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
411894|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
411895|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
411896|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
411897|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
411898|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
411899|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
411900|NCT00966446|E3|Reported Event|No Intervention|Households do not undergo active MRSA decolonization protocol
411901|NCT00966446|E2|Reported Event|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
411902|NCT00966446|E1|Reported Event|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
411903|NCT00966355|B4|Baseline|Total|Total of all reporting groups
411904|NCT00966355|B3|Baseline|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
411905|NCT00966355|B2|Baseline|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
411906|NCT00966355|B1|Baseline|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
411976|NCT00966186|E1|Reported Event|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
411909|NCT00966355|P1|Participant Flow|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
411910|NCT00966355|O3|Outcome|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
411911|NCT00966355|O2|Outcome|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
411912|NCT00966355|O1|Outcome|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
411913|NCT00966355|O3|Outcome|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
411914|NCT00966355|O2|Outcome|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
411915|NCT00966355|O1|Outcome|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
411916|NCT00966355|E3|Reported Event|Terlipressin|"treat with terlipressin IV for 5 days and endoscopic treatment~Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days"
411917|NCT00966355|E2|Reported Event|Somatostatin|"treat with somatostatin IV for 5 days and endoscopic treatment~Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days"
411918|NCT00966355|E1|Reported Event|Octreotide|"treat with octreotide IV for 5 days and endoscopic treatment~Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days"
411919|NCT00966277|B3|Baseline|Total|Total of all reporting groups
411920|NCT00966277|B2|Baseline|Group 2: Control|No Dalteparin study drug.
411921|NCT00966277|B1|Baseline|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
411922|NCT00966277|P2|Participant Flow|Group 2: Control|No Dalteparin study drug (primary prophylaxis).
411923|NCT00966277|P1|Participant Flow|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
411924|NCT00966277|O2|Outcome|Group 2: Control|No Dalteparin study drug.
411925|NCT00966277|O1|Outcome|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
411926|NCT00966277|E2|Reported Event|Group 2: Control|No Dalteparin study drug.
411927|NCT00966277|E1|Reported Event|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
411928|NCT00966264|B3|Baseline|Total|Total of all reporting groups
411929|NCT00966264|B2|Baseline|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
411930|NCT00966264|B1|Baseline|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
411931|NCT00966264|P2|Participant Flow|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
411932|NCT00966264|P1|Participant Flow|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
411933|NCT00966264|O2|Outcome|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
411934|NCT00966264|O1|Outcome|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
411935|NCT00966264|E2|Reported Event|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
411936|NCT00966264|E1|Reported Event|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
411937|NCT00966238|B7|Baseline|Total|Total of all reporting groups
411938|NCT00966238|B6|Baseline|8.0 µg i.m.|
411939|NCT00966238|B5|Baseline|5.0 µg i.m.|
411940|NCT00966238|B4|Baseline|3.0 µg i.m.|
411941|NCT00966238|B3|Baseline|2.0 µg i.m.|
411942|NCT00966238|B2|Baseline|1.0 µg i.m.|
411943|NCT00966238|B1|Baseline|0.5 µg i.m.|
411944|NCT00966238|P6|Participant Flow|8.0 µg i.m.|
411945|NCT00966238|P5|Participant Flow|5.0 µg i.m.|
411946|NCT00966238|P4|Participant Flow|3.0 µg i.m.|
411947|NCT00966238|P3|Participant Flow|2.0 µg i.m.|
411948|NCT00966238|P2|Participant Flow|1.0 µg i.m.|
411949|NCT00966238|P1|Participant Flow|0.5 µg i.m.|
411950|NCT00966238|O6|Outcome|8.0 µg i.m.|
411951|NCT00966238|O5|Outcome|5.0 µg i.m.|
411952|NCT00966238|O4|Outcome|3.0 µg i.m.|
411953|NCT00966238|O3|Outcome|2.0 µg i.m.|
411954|NCT00966238|O2|Outcome|1.0 µg i.m.|
411955|NCT00966238|O1|Outcome|0.5 µg i.m.|
411956|NCT00966238|O6|Outcome|8.0 µg i.m.|
411957|NCT00966238|O5|Outcome|5.0 µg i.m.|
411958|NCT00966238|O4|Outcome|3.0 µg i.m.|
411959|NCT00966238|O3|Outcome|2.0 µg i.m.|
411960|NCT00966238|O2|Outcome|1.0 µg i.m.|
411961|NCT00966238|O1|Outcome|0.5 µg i.m.|
411962|NCT00966238|E6|Reported Event|8.0 µg i.m.|
411963|NCT00966238|E5|Reported Event|5.0 µg i.m.|
411964|NCT00966238|E4|Reported Event|3.0 µg i.m.|
411965|NCT00966238|E3|Reported Event|2.0 µg i.m.|
411966|NCT00966238|E2|Reported Event|1.0 µg i.m.|
411967|NCT00966238|E1|Reported Event|0.5 µg i.m.|
411968|NCT00966186|B3|Baseline|Total|Total of all reporting groups
411969|NCT00966186|B2|Baseline|Rotational Technique|
411970|NCT00966186|B1|Baseline|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
411971|NCT00966186|P2|Participant Flow|Rotational Technique|
411972|NCT00966186|P1|Participant Flow|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
411973|NCT00966186|O2|Outcome|Rotational Technique|
411974|NCT00966186|O1|Outcome|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
411975|NCT00966186|E2|Reported Event|Rotational Technique|
411977|NCT00965848|B1|Baseline|Entire Study Population|
411978|NCT00965848|P3|Participant Flow|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
411979|NCT00965848|P2|Participant Flow|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
411980|NCT00965848|P1|Participant Flow|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
411981|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
411982|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
411983|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
411984|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
411985|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
411986|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
411987|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
411988|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
411989|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
411990|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
411991|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
411992|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
411993|NCT00965848|E3|Reported Event|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
411994|NCT00965848|E2|Reported Event|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
411995|NCT00965848|E1|Reported Event|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
411996|NCT00965757|B3|Baseline|Total|Total of all reporting groups
411997|NCT00965757|B2|Baseline|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
411998|NCT00965757|B1|Baseline|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
411999|NCT00965757|P4|Participant Flow|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412000|NCT00965757|P3|Participant Flow|T-614 (Extension, 29-52 Weeks)|T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
412001|NCT00965757|P2|Participant Flow|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412002|NCT00965757|P1|Participant Flow|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
412003|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412004|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412054|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412478|NCT00964431|O3|Outcome|Celecoxib 400 mg|
412005|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412006|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412007|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412008|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412009|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412010|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412011|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412012|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412013|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412014|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412015|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412016|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412017|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412018|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412019|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412020|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412021|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412022|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412023|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412024|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412025|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412026|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412027|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412028|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412029|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412030|NCT00965757|E3|Reported Event|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
412031|NCT00965757|E2|Reported Event|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
412032|NCT00965757|E1|Reported Event|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
412033|NCT00965731|B3|Baseline|Total|Total of all reporting groups
412034|NCT00965731|B2|Baseline|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412035|NCT00965731|B1|Baseline|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412036|NCT00965731|P2|Participant Flow|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412037|NCT00965731|P1|Participant Flow|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412038|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412039|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412040|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412041|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341033 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles
412042|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412043|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412044|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412045|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412046|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412047|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412048|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412049|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412050|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412051|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412052|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412053|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412055|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412056|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412057|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412058|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412059|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412060|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
412061|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412062|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412063|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412064|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412065|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412066|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412067|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412068|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412069|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412070|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412071|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412072|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412073|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412074|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412075|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412076|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412145|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412146|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412077|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412078|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412079|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412080|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412081|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412082|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412083|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412084|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412085|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412086|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412087|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412088|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412089|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412090|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412091|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412092|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412093|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412094|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles
412095|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
412147|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412148|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412096|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412097|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412098|NCT00965731|E2|Reported Event|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412099|NCT00965731|E1|Reported Event|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
412100|NCT00965718|B1|Baseline|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412101|NCT00965718|P1|Participant Flow|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412102|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412103|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412104|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412105|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412106|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412107|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412108|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412109|NCT00965718|E1|Reported Event|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
412110|NCT00965562|B4|Baseline|Total|Total of all reporting groups
412111|NCT00965562|B3|Baseline|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412112|NCT00965562|B2|Baseline|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412113|NCT00965562|B1|Baseline|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412114|NCT00965562|P3|Participant Flow|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412115|NCT00965562|P2|Participant Flow|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412116|NCT00965562|P1|Participant Flow|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412117|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412118|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412119|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412120|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412121|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412122|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412123|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412124|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412125|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412126|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412127|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412128|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412129|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412130|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412131|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412132|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412133|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412134|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412135|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412136|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412137|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412138|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
412139|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412140|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412141|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
412142|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
412143|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
412144|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
412154|NCT00965523|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
412155|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
412156|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
412157|NCT00965523|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
412158|NCT00965497|B1|Baseline|Open-label, Single Arm|All patients will receive the intervention
412159|NCT00965497|P1|Participant Flow|Open-label, Single Arm|All patients will receive the intervention
412160|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
412161|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
412162|NCT00965497|E1|Reported Event|Open-label, Single Arm|All patients will receive the intervention
412163|NCT00965484|B1|Baseline|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
412164|NCT00965484|P1|Participant Flow|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
412165|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
412166|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
412167|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
412168|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
412169|NCT00965484|E1|Reported Event|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
412170|NCT00965458|B3|Baseline|Total|Total of all reporting groups
412171|NCT00965458|B2|Baseline|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
412172|NCT00965458|B1|Baseline|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
412173|NCT00965458|P2|Participant Flow|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412174|NCT00965458|P1|Participant Flow|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412175|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412176|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412177|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412178|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412179|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412180|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412181|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412182|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412183|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412184|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
412185|NCT00965458|O2|Outcome|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
412186|NCT00965458|O1|Outcome|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
412187|NCT00965458|E2|Reported Event|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
412188|NCT00965458|E1|Reported Event|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
412189|NCT00965419|B1|Baseline|All Participants|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412190|NCT00965419|P1|Participant Flow|Edivoxetine|Edivoxetine: 0.1 milligram (mg)/kilogram (kg)/day or participant specific known stable dose, rollover participants (LNBJ [No NCT number]) and (LNBF [NCT00922636]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412191|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412192|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412193|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412194|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412195|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412196|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412197|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412198|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412199|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412200|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412201|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412202|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412203|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412204|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412205|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412206|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412207|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412208|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412209|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412210|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412211|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412212|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412213|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412214|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412215|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412216|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412217|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412218|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412219|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412220|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412221|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412222|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412223|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412479|NCT00964431|O2|Outcome|Indomethacin Test (Upper Dose)|40-mg
412224|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412225|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412226|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412227|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412228|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412229|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412230|NCT00965419|O1|Outcome|Edivoxetine|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412231|NCT00965419|E2|Reported Event|Edivoxetine (Follow Up)|The follow up period is an optional taper of Edivoxetine. Treatment may be tapered or discontinued, over a period of 10 to 18 days.
412232|NCT00965419|E1|Reported Event|Edivoxetine (Open-Label)|Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
412233|NCT00965341|B3|Baseline|Total|Total of all reporting groups
412234|NCT00965341|B2|Baseline|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
412235|NCT00965341|B1|Baseline|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
412236|NCT00965341|P2|Participant Flow|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
412237|NCT00965341|P1|Participant Flow|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
412238|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
412239|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
412240|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
412241|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
412242|NCT00965341|E2|Reported Event|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
412243|NCT00965341|E1|Reported Event|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
412244|NCT00965263|B3|Baseline|Total|Total of all reporting groups
412245|NCT00965263|B2|Baseline|High Dose Vaccine (360μg)|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9."
412246|NCT00965263|B1|Baseline|Low Dose Vaccine (82μg)|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9."
412247|NCT00965263|P2|Participant Flow|High Dose Vaccine|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9."
412248|NCT00965263|P1|Participant Flow|Low Dose Vaccine|"All participants were vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9."
412249|NCT00965263|O6|Outcome|High Antibody/50mg Cocaine|High Antibody/50mg Cocaine.
412250|NCT00965263|O5|Outcome|High Antibody/25mg Cocaine|High Antibody/25mg Cocaine.
412251|NCT00965263|O4|Outcome|High Antibody/0mg Cocaine|High Antibody/0mg Cocaine.
412252|NCT00965263|O3|Outcome|Low Antibody/50mg Cocaine|Low Antibody/50mg Cocaine.
412253|NCT00965263|O2|Outcome|Low Antibody/25mg Cocaine|Low Antibody/25mg Cocaine.
412254|NCT00965263|O1|Outcome|Low Antibody/0mg Cocaine|Low Antibody/0mg Cocaine.
412255|NCT00965263|O6|Outcome|High Antibody/50mg Cocaine|High Antibody/50mg Cocaine.
412256|NCT00965263|O5|Outcome|High Antibody/25mg Cocaine|High Antibody/25mg Cocaine.
412257|NCT00965263|O4|Outcome|High Antibody/0mg Cocaine|High Antibody/0mg Cocaine.
412258|NCT00965263|O3|Outcome|Low Antibody/50mg Cocaine|Low Antibody/50mg Cocaine.
412259|NCT00965263|O2|Outcome|Low Antibody/25mg Cocaine|Low Antibody/25mg Cocaine.
412260|NCT00965263|O1|Outcome|Low Antibody/0mg Cocaine|Low Antibody/0mg Cocaine.
412261|NCT00965263|O14|Outcome|Week 13 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412262|NCT00965263|O13|Outcome|Week 11 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412263|NCT00965263|O12|Outcome|Week 9 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412264|NCT00965263|O11|Outcome|Week 7 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412265|NCT00965263|O10|Outcome|Week 5 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412266|NCT00965263|O9|Outcome|Week 3 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412267|NCT00965263|O8|Outcome|Week 1 High Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412390|NCT00964886|O1|Outcome|Arm 1 + Arm 3|Factor all participants assigned at baseline to receive desipramine hydrochloride
412268|NCT00965263|O7|Outcome|Week 13 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412269|NCT00965263|O6|Outcome|Week 11 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412270|NCT00965263|O5|Outcome|Week 9 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412271|NCT00965263|O4|Outcome|Week 7 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412272|NCT00965263|O3|Outcome|Week 5 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412273|NCT00965263|O2|Outcome|Week 3 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412274|NCT00965263|O1|Outcome|Week 1 Low Antibody|Participants were evenly divided into low antibody and high antibody groups based on their peak antibody levels at week 13.
412275|NCT00965263|E2|Reported Event|High Dose Vaccine|"Each of six participants was vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (360 μg; IM) were administered at weeks 1, 3, 5 and 9."
412276|NCT00965263|E1|Reported Event|Low Dose Vaccine|"Each of four participants was vaccinated four times: in week 1, 3, 5, and 9.~Cocaine vaccine (TA-CD): TA-CD (82 μg; IM) were administered at weeks 1, 3, 5 and 9."
412277|NCT00965250|B3|Baseline|Total|Total of all reporting groups
412278|NCT00965250|B2|Baseline|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412279|NCT00965250|B1|Baseline|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412280|NCT00965250|P2|Participant Flow|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412281|NCT00965250|P1|Participant Flow|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412282|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412283|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412284|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412285|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412286|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412287|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412288|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412289|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412290|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412291|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412292|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412293|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412294|NCT00965250|O1|Outcome|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
412295|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412296|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
412297|NCT00965250|E1|Reported Event|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
412298|NCT00965237|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
412299|NCT00965237|P2|Participant Flow|Single Vision CL + Reading Glasses / Multifocal CL|Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
412300|NCT00965237|P1|Participant Flow|Multifocal CL / Single Vision CL+ Reading Glasses|Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
412301|NCT00965237|O2|Outcome|Lotrafilcon B Single Vision Contact Lens + Reading Glasses|Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed
412302|NCT00965237|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Commercially marketed, lotrafilcon B, silicone hydrogel, multifocal contact lens for daily wear use
412303|NCT00965237|E2|Reported Event|Single Vision Contact Lens|Commercially marketed lotrafilcon B single vision contact lenses
412304|NCT00965237|E1|Reported Event|Multifocal Contact Lens|Commercially marketed lotrafilcon B multifocal contact lenses
412305|NCT00965185|B3|Baseline|Total|Total of all reporting groups
412306|NCT00965185|B2|Baseline|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412307|NCT00965185|B1|Baseline|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412308|NCT00965185|P2|Participant Flow|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412309|NCT00965185|P1|Participant Flow|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412310|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412311|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412312|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412313|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412314|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412315|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412316|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412317|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412318|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412319|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412320|NCT00965185|O2|Outcome|Placebo|Placebo: Placebo
412321|NCT00965185|O1|Outcome|Atorvastatin|"20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.~atorvastatin: 20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months."
412322|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412323|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412324|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412325|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412326|NCT00965185|E2|Reported Event|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
412327|NCT00965185|E1|Reported Event|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
412328|NCT00965146|B1|Baseline|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
412329|NCT00965146|P1|Participant Flow|Scorpio® CR Device|All subjects were implanted with the Scorpio® CR Total Knee System Study Device
412330|NCT00965146|O1|Outcome|Scorpio® CR Device|All subjects received the Scorpio® CR Device
412331|NCT00965146|O1|Outcome|Scorpio® CR Device|All subjects received the Scorpio® CR Device
412332|NCT00965146|E1|Reported Event|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
412333|NCT00965094|B3|Baseline|Total|Total of all reporting groups
412391|NCT00964886|O2|Outcome|Arm 2 + Arm 4|"Factor anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
412334|NCT00965094|B2|Baseline|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412335|NCT00965094|B1|Baseline|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412336|NCT00965094|P2|Participant Flow|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412337|NCT00965094|P1|Participant Flow|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412338|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412339|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412340|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412341|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412342|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412343|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412344|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412345|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412346|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412347|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412348|NCT00965094|E2|Reported Event|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
412349|NCT00965094|E1|Reported Event|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
412350|NCT00965081|B3|Baseline|Total|Total of all reporting groups
412351|NCT00965081|B2|Baseline|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412352|NCT00965081|B1|Baseline|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412353|NCT00965081|P2|Participant Flow|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412354|NCT00965081|P1|Participant Flow|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412355|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412356|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412357|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412358|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412359|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412360|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412361|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412392|NCT00964886|O1|Outcome|Arm 1 + Arm 3|"Factor desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
412362|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412363|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412364|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412365|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412366|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412367|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412368|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412369|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412370|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412371|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412372|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
412373|NCT00965081|E3|Reported Event|Duloxetine 60 mg|Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
412374|NCT00965081|E2|Reported Event|Duloxetine 30 mg|Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks
412375|NCT00965081|E1|Reported Event|Placebo|Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks.
412376|NCT00964886|B5|Baseline|Total|Total of all reporting groups
412377|NCT00964886|B4|Baseline|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
412378|NCT00964886|B3|Baseline|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
412379|NCT00964886|B2|Baseline|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
412380|NCT00964886|B1|Baseline|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
412381|NCT00964886|P4|Participant Flow|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
412382|NCT00964886|P3|Participant Flow|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
412383|NCT00964886|P2|Participant Flow|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
412384|NCT00964886|P1|Participant Flow|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
412385|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor all participants assigned at baseline not to receive cognitive behavioral therapy
412386|NCT00964886|O1|Outcome|Arm 2 + Arm 3|Factor all participants assigned at baseline to receive cognitive behavioral therapy
412387|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor no cognitive behavioral therapy
412388|NCT00964886|O1|Outcome|Arm 2 + Arm 3|"Factor cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
412389|NCT00964886|O2|Outcome|Arm 2 + Arm 4|Factor all participants assigned at baseline to receive benztropine mesylate (active placebo)
412393|NCT00964886|E4|Reported Event|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
412394|NCT00964886|E3|Reported Event|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
412395|NCT00964886|E2|Reported Event|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
412396|NCT00964886|E1|Reported Event|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
412397|NCT00964860|B3|Baseline|Total|Total of all reporting groups
412398|NCT00964860|B2|Baseline|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
412399|NCT00964860|B1|Baseline|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
412400|NCT00964860|P2|Participant Flow|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
412401|NCT00964860|P1|Participant Flow|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
412402|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
412403|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
412404|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
412405|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
412406|NCT00964860|E2|Reported Event|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
412407|NCT00964860|E1|Reported Event|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
412408|NCT00964795|B1|Baseline|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
412409|NCT00964795|P1|Participant Flow|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
412410|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
412411|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
412412|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
412413|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
412480|NCT00964431|O1|Outcome|Indomethacin Test (Lower Dose)|20-mg
412414|NCT00964795|E1|Reported Event|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
412415|NCT00964743|B1|Baseline|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412416|NCT00964743|P1|Participant Flow|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412417|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412418|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412419|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412420|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412421|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412422|NCT00964743|E1|Reported Event|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
412423|NCT00964678|B1|Baseline|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
412424|NCT00964678|P1|Participant Flow|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
412425|NCT00964678|O1|Outcome|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
412426|NCT00964678|O1|Outcome|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
412427|NCT00964678|O1|Outcome|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
412428|NCT00964678|O1|Outcome|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
412429|NCT00964678|E1|Reported Event|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
412430|NCT00964548|B3|Baseline|Total|Total of all reporting groups
412431|NCT00964548|B2|Baseline|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
412432|NCT00964548|B1|Baseline|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
412433|NCT00964548|P2|Participant Flow|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
412434|NCT00964548|P1|Participant Flow|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
412435|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
412436|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
412481|NCT00964431|E4|Reported Event|Placebo|
412438|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
412439|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
412440|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
412441|NCT00964548|E2|Reported Event|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
412442|NCT00964548|E1|Reported Event|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
412443|NCT00964496|B3|Baseline|Total|Total of all reporting groups
412444|NCT00964496|B2|Baseline|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412445|NCT00964496|B1|Baseline|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412446|NCT00964496|P2|Participant Flow|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412447|NCT00964496|P1|Participant Flow|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412448|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412449|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412450|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412451|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412452|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412453|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412454|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412455|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412456|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412457|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412458|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412459|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412460|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412461|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412462|NCT00964496|E2|Reported Event|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412463|NCT00964496|E1|Reported Event|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
412464|NCT00964444|B1|Baseline|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
412465|NCT00964444|P1|Participant Flow|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
412466|NCT00964444|O1|Outcome|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
412467|NCT00964444|E1|Reported Event|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
412468|NCT00964431|B5|Baseline|Total|Total of all reporting groups
412469|NCT00964431|B4|Baseline|Placebo|
412470|NCT00964431|B3|Baseline|Celecoxib 400 mg|
412471|NCT00964431|B2|Baseline|Indomethacin Test (Upper Dose)|Single dose
412472|NCT00964431|B1|Baseline|Indomethacin Test (Lower Dose)|
412473|NCT00964431|P4|Participant Flow|Placebo|
412474|NCT00964431|P3|Participant Flow|Celecoxib 400 mg|
412475|NCT00964431|P2|Participant Flow|Indomethacin Test (Upper Dose)|Single dose
412476|NCT00964431|P1|Participant Flow|Indomethacin Test (Lower Dose)|
412477|NCT00964431|O4|Outcome|Placebo|
412486|NCT00964392|B2|Baseline|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
412487|NCT00964392|B1|Baseline|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
412488|NCT00964392|P2|Participant Flow|Less-Experienced Physicians (LEP)|LEP are defined as those who have performed less than or equal to 50 AF ablations per year.
412489|NCT00964392|P1|Participant Flow|More-Experienced Physicians (MEP)|MEP are defined as those who have performed greater than 50 AF ablation cases per year.
412490|NCT00964392|O2|Outcome|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
412491|NCT00964392|O1|Outcome|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
412492|NCT00964392|O2|Outcome|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
412493|NCT00964392|O1|Outcome|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
412494|NCT00964392|E2|Reported Event|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
412495|NCT00964392|E1|Reported Event|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
412496|NCT00964366|B3|Baseline|Total|Total of all reporting groups
412497|NCT00964366|B2|Baseline|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412498|NCT00964366|B1|Baseline|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412499|NCT00964366|P2|Participant Flow|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412500|NCT00964366|P1|Participant Flow|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412501|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412502|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412503|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412504|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412505|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412506|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412687|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412507|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412508|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412509|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412510|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412511|NCT00964366|E2|Reported Event|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412512|NCT00964366|E1|Reported Event|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
412513|NCT00964223|B1|Baseline|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412514|NCT00964223|P1|Participant Flow|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412515|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412516|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412517|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412518|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412519|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412520|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412521|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412522|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412523|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412524|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412525|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412526|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412527|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412528|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412529|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412530|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412531|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412532|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412533|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412534|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412535|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412536|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412537|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412538|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412539|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412540|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412541|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412542|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
419215|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
412543|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412544|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412545|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412546|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412547|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412548|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412549|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412550|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412551|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412552|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412553|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412554|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412555|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412556|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412557|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412558|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412559|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412560|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
413751|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
412561|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412562|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412563|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412564|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412565|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412566|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412567|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412568|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412569|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412570|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412571|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412572|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412573|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412574|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412575|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412576|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412577|NCT00964223|E1|Reported Event|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
412578|NCT00964158|B4|Baseline|Total|Total of all reporting groups
412579|NCT00964158|B3|Baseline|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
413752|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
412580|NCT00964158|B2|Baseline|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412581|NCT00964158|B1|Baseline|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412582|NCT00964158|P3|Participant Flow|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412583|NCT00964158|P2|Participant Flow|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412584|NCT00964158|P1|Participant Flow|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412585|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412586|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412587|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412588|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412589|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412590|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412591|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412592|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412593|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412594|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412595|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412596|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412597|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412598|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412599|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412600|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412601|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412602|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412603|NCT00964158|O2|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412604|NCT00964158|O1|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412605|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412606|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412607|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412608|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412609|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412610|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412611|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412612|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412613|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412614|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412615|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412616|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412617|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412618|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412619|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412620|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412621|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412622|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412623|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412624|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412625|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412626|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412627|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412628|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412629|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412630|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412631|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412632|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412633|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412634|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412635|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412636|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412637|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412638|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412639|NCT00964158|O3|Outcome|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412640|NCT00964158|O2|Outcome|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412641|NCT00964158|O1|Outcome|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412642|NCT00964158|O1|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412643|NCT00964158|O1|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412644|NCT00964158|O1|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412645|NCT00964158|O1|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412646|NCT00964158|O1|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412647|NCT00964158|O1|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412648|NCT00964158|O1|Outcome|GSK2340272A Group|Healthy male or female children between 3 to 17 years of age, who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412649|NCT00964158|E3|Reported Event|GSK2340272A (10-17Y) Group|Healthy male or female children between 10 to 17 years of age (10-17Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412650|NCT00964158|E2|Reported Event|GSK2340272A (6-9Y) Group|Healthy male or female children between 6 to 9 years of age (6-9Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412651|NCT00964158|E1|Reported Event|GSK2340272A (3-5Y) Group|Healthy male or female children between 3 to 5 years of age (3-5Y), who received 2 primary doses of GSK2340272A vaccine according to a 0, 21-day schedule, administered intramuscularly in the deltoid region of the arm.
412652|NCT00964119|B1|Baseline|Single Cohort Observational|
412653|NCT00964119|P1|Participant Flow|Single Cohort Obervational|
412654|NCT00964119|O1|Outcome|Single Cohort Observational|
412655|NCT00964119|E1|Reported Event|Single Cohort Observational|
412656|NCT00964028|B3|Baseline|Total|Total of all reporting groups
412657|NCT00964028|B2|Baseline|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
412658|NCT00964028|B1|Baseline|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
412659|NCT00964028|P2|Participant Flow|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
412660|NCT00964028|P1|Participant Flow|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
413753|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
412661|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
412662|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
412663|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
412664|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
412665|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
412666|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
412667|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
412668|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
412669|NCT00964028|E2|Reported Event|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
412670|NCT00964028|E1|Reported Event|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
412671|NCT00963937|B4|Baseline|Total|Total of all reporting groups
412672|NCT00963937|B3|Baseline|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412673|NCT00963937|B2|Baseline|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412674|NCT00963937|B1|Baseline|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412675|NCT00963937|P3|Participant Flow|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412676|NCT00963937|P2|Participant Flow|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412677|NCT00963937|P1|Participant Flow|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412678|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412679|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412680|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412681|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412682|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412683|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412684|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412685|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412686|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412688|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412689|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412690|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412691|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412692|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412693|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412694|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412695|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412696|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412697|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412698|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412699|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412700|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412701|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412702|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412703|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412704|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412705|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412706|NCT00963937|O2|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412707|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412708|NCT00963937|E4|Reported Event|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
412709|NCT00963937|E3|Reported Event|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412710|NCT00963937|E2|Reported Event|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
412711|NCT00963937|E1|Reported Event|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
412712|NCT00963924|B3|Baseline|Total|Total of all reporting groups
412713|NCT00963924|B2|Baseline|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412714|NCT00963924|B1|Baseline|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412715|NCT00963924|P2|Participant Flow|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412716|NCT00963924|P1|Participant Flow|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412717|NCT00963924|O2|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
413206|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
412718|NCT00963924|O1|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412719|NCT00963924|O2|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412720|NCT00963924|O1|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412721|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412722|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412723|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412724|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412725|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412726|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412727|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412728|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412729|NCT00963924|O2|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412730|NCT00963924|O1|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412731|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412732|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412733|NCT00963924|O2|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412734|NCT00963924|O1|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
412735|NCT00963924|E2|Reported Event|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412736|NCT00963924|E1|Reported Event|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
412737|NCT00963872|B3|Baseline|Total|Total of all reporting groups
412738|NCT00963872|B2|Baseline|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412739|NCT00963872|B1|Baseline|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412740|NCT00963872|P2|Participant Flow|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412741|NCT00963872|P1|Participant Flow|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412742|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412743|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
419216|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
412744|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412745|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412746|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412747|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412748|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412749|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412750|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412751|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412752|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412753|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412754|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412755|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412756|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412757|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412758|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412759|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412760|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412761|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412762|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412763|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412764|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412765|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412766|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412767|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412768|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412769|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412770|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412771|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412772|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412773|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412774|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412775|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412776|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412777|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412778|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
413084|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
412779|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412780|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412781|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412782|NCT00963872|E2|Reported Event|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
412783|NCT00963872|E1|Reported Event|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
412784|NCT00963859|B1|Baseline|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
412785|NCT00963859|P1|Participant Flow|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
412786|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
412787|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
412788|NCT00963859|E1|Reported Event|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
412789|NCT00963820|B1|Baseline|Overall Study|Safety Population
412790|NCT00963820|P12|Participant Flow|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412791|NCT00963820|P11|Participant Flow|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412792|NCT00963820|P10|Participant Flow|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412793|NCT00963820|P9|Participant Flow|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established Maximum Tolerated Dose (MTD), capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412794|NCT00963820|P8|Participant Flow|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412795|NCT00963820|P7|Participant Flow|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412796|NCT00963820|P6|Participant Flow|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412797|NCT00963820|P5|Participant Flow|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412798|NCT00963820|P4|Participant Flow|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412799|NCT00963820|P3|Participant Flow|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412800|NCT00963820|P2|Participant Flow|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412801|NCT00963820|P1|Participant Flow|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412802|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412803|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412804|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412851|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412805|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412806|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412807|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412808|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412809|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412810|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412811|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412812|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412813|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412814|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412815|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412816|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412817|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412818|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412819|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412820|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412821|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412822|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412823|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412824|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412825|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412826|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412827|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412965|NCT00963599|B5|Baseline|Total|Total of all reporting groups
412828|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412829|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412830|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412831|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412832|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412833|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412834|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412835|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412836|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412837|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412838|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412839|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412840|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412841|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412842|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412843|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412844|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412845|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412846|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412847|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412848|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412849|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412850|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412852|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412853|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412854|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412855|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412856|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412857|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412858|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412859|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412860|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412861|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412862|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412863|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412864|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412865|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412866|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412867|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412868|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412869|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412870|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412871|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412872|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412873|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412874|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412875|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412876|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412877|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412878|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412879|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412880|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412881|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412882|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412883|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412884|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412885|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412886|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412887|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412888|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412889|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412890|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412891|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412892|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412893|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412894|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412895|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412896|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412897|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
413754|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
412898|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412899|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412900|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412901|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412902|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412903|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412904|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412905|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412906|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412907|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412908|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412909|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412910|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412911|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412912|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412913|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412914|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412915|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412916|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412917|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412918|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412919|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412920|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412921|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412922|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412923|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412924|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412925|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412926|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412927|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412928|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412929|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412930|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412931|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412932|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412933|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412934|NCT00963820|E2|Reported Event|Expansion Cohorts|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412935|NCT00963820|E1|Reported Event|Dose Escalation Cohorts|Ixazomib citrate, 0.24 to 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
412936|NCT00963807|B1|Baseline|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
412937|NCT00963807|P1|Participant Flow|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
412938|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
412966|NCT00963599|B4|Baseline|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
413085|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
412939|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
412940|NCT00963807|O2|Outcome|Non-Responders|RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
412941|NCT00963807|O1|Outcome|Responders|RECIST responders based on CT measurements performed after 2 cycles of neoadjuvant therapy.
412942|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
412943|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
412944|NCT00963807|E1|Reported Event|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
412945|NCT00963677|B3|Baseline|Total|Total of all reporting groups
412946|NCT00963677|B2|Baseline|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
412947|NCT00963677|B1|Baseline|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
412948|NCT00963677|P2|Participant Flow|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
412949|NCT00963677|P1|Participant Flow|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
412950|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
412951|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
412952|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
412953|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
412954|NCT00963677|E2|Reported Event|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
412955|NCT00963677|E1|Reported Event|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
412956|NCT00963638|B3|Baseline|Total|Total of all reporting groups
412957|NCT00963638|B2|Baseline|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
412958|NCT00963638|B1|Baseline|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
412959|NCT00963638|P2|Participant Flow|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
412960|NCT00963638|P1|Participant Flow|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
412961|NCT00963638|O2|Outcome|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
412962|NCT00963638|O1|Outcome|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
412963|NCT00963638|E2|Reported Event|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
412964|NCT00963638|E1|Reported Event|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
412967|NCT00963599|B3|Baseline|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412968|NCT00963599|B2|Baseline|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412969|NCT00963599|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412970|NCT00963599|P4|Participant Flow|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412971|NCT00963599|P3|Participant Flow|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412972|NCT00963599|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412973|NCT00963599|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412974|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412975|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412976|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412977|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412978|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412979|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412980|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412981|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412982|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412983|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412984|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412985|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412986|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412987|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412988|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412989|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412990|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412991|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412992|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412993|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412994|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412995|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412996|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412997|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
412998|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
412999|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413000|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
419217|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
413001|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413002|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
413003|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413004|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413005|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413006|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
413007|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413008|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413009|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413010|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
413011|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413012|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413013|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413014|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
413015|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413016|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413017|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413018|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
413019|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413020|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413021|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413022|NCT00963599|E4|Reported Event|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
413023|NCT00963599|E3|Reported Event|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413024|NCT00963599|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413025|NCT00963599|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
413026|NCT00963560|B4|Baseline|Total|Total of all reporting groups
413027|NCT00963560|B3|Baseline|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
413028|NCT00963560|B2|Baseline|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
413029|NCT00963560|B1|Baseline|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
413030|NCT00963560|P3|Participant Flow|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
413031|NCT00963560|P2|Participant Flow|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
413032|NCT00963560|P1|Participant Flow|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
413033|NCT00963560|O3|Outcome|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
413034|NCT00963560|O2|Outcome|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
413035|NCT00963560|O1|Outcome|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
413036|NCT00963560|E3|Reported Event|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
413037|NCT00963560|E2|Reported Event|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
413038|NCT00963560|E1|Reported Event|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
413039|NCT00963508|B3|Baseline|Total|Total of all reporting groups
413040|NCT00963508|B2|Baseline|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
413755|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413041|NCT00963508|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
413042|NCT00963508|P2|Participant Flow|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
413043|NCT00963508|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
413044|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
413045|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
413046|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
413047|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
413048|NCT00963508|E2|Reported Event|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
413049|NCT00963508|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
413050|NCT00963482|B3|Baseline|Total|Total of all reporting groups
413051|NCT00963482|B2|Baseline|Control Group|Autogenic training
413052|NCT00963482|B1|Baseline|Intervention Group|Cognitive-behavioural smoking cessation program
413053|NCT00963482|P2|Participant Flow|Control Group|Autogenic training
413054|NCT00963482|P1|Participant Flow|Intervention Group|Cognitive-behavioural smoking cessation program
413055|NCT00963482|O2|Outcome|Control Group|Autogenic training
413056|NCT00963482|O1|Outcome|Intervention Group|Cognitive-behavioural smoking cessation program
413057|NCT00963482|E2|Reported Event|Control Group|Autogenic training
413058|NCT00963482|E1|Reported Event|Intervention Group|Cognitive-behavioural smoking cessation program
413059|NCT00963469|B4|Baseline|Total|Total of all reporting groups
413060|NCT00963469|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413061|NCT00963469|B2|Baseline|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413062|NCT00963469|B1|Baseline|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413063|NCT00963469|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413064|NCT00963469|P2|Participant Flow|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413065|NCT00963469|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413066|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413067|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413068|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413069|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413070|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413071|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413072|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413073|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413074|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413075|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413076|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413077|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413078|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413079|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413080|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413081|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413082|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413083|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413086|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413087|NCT00963469|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
413088|NCT00963469|E2|Reported Event|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413089|NCT00963469|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
413090|NCT00963430|B3|Baseline|Total|Total of all reporting groups
413091|NCT00963430|B2|Baseline|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413092|NCT00963430|B1|Baseline|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413093|NCT00963430|P2|Participant Flow|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413094|NCT00963430|P1|Participant Flow|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413095|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413096|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413097|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413098|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413099|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413100|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413101|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413102|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413103|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413104|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413105|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413106|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413107|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413108|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413109|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413110|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413111|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413112|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413113|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413114|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413115|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413116|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413117|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413118|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413119|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413120|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413121|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413122|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413123|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413124|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413125|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413126|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413127|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413128|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413129|NCT00963430|E2|Reported Event|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413130|NCT00963430|E1|Reported Event|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
413131|NCT00963235|B1|Baseline|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413132|NCT00963235|P1|Participant Flow|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413133|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413134|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413135|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413136|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413137|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413138|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413139|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413140|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413141|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413142|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413143|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413144|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413145|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
413146|NCT00963235|E4|Reported Event|13vPnC (After Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
413147|NCT00963235|E3|Reported Event|13vPnC (After Dose 3 and Before Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.
413148|NCT00963235|E2|Reported Event|13vPnC (After Dose 2 and Before Dose 3)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.
413149|NCT00963235|E1|Reported Event|13vPnC (After Dose 1 and Before Dose 2)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.
413150|NCT00963157|B6|Baseline|Total|Total of all reporting groups
413151|NCT00963157|B5|Baseline|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413152|NCT00963157|B4|Baseline|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413153|NCT00963157|B3|Baseline|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413154|NCT00963157|B2|Baseline|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413155|NCT00963157|B1|Baseline|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413156|NCT00963157|P5|Participant Flow|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413157|NCT00963157|P4|Participant Flow|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413158|NCT00963157|P3|Participant Flow|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413159|NCT00963157|P2|Participant Flow|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413160|NCT00963157|P1|Participant Flow|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413161|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413162|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413163|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413164|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413165|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413166|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413167|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413168|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413169|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413170|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413171|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413172|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413173|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413174|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413175|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413176|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413177|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413178|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413179|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413180|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413181|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413182|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413183|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413184|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413185|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413186|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413187|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413188|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413189|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413190|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413191|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413192|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413193|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413194|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413195|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413196|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413197|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413198|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413199|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413200|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413201|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413202|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413203|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413204|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413205|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413207|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413208|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413209|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413210|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413211|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413212|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413213|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413214|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413215|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413216|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413217|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413218|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413219|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413220|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413221|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413222|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413223|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413224|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413225|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413226|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413227|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413228|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413229|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413230|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413231|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413232|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413233|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413234|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413235|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413236|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413237|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413238|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413239|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413240|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413241|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413242|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413243|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413244|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413245|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413246|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413247|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413248|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413249|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413250|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413251|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413252|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
419218|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
413253|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413254|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413255|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413256|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413257|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413258|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413259|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413260|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413261|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413262|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413263|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413264|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413265|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413266|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413267|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413268|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413269|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413270|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413271|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413272|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413273|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413274|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413275|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413276|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413277|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413278|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413279|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413280|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413281|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413282|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413283|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413284|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413285|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413286|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413287|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413288|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413289|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413290|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413291|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413292|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413293|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413294|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413295|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413296|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413297|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413298|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
419219|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
413299|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413300|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413301|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413302|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413303|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413304|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413305|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413306|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413307|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413308|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413309|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413310|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413311|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413312|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413313|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413314|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413315|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413316|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413317|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413318|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413319|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413320|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413321|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413322|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413323|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413324|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413325|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413326|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413327|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413328|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413329|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413330|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413331|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413332|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413333|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413334|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413335|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413336|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413337|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413338|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413339|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413340|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413341|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413342|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413343|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413344|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
419220|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
413345|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413346|NCT00963157|E5|Reported Event|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413347|NCT00963157|E4|Reported Event|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413348|NCT00963157|E3|Reported Event|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
413349|NCT00963157|E2|Reported Event|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413350|NCT00963157|E1|Reported Event|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
413351|NCT00962871|B5|Baseline|Total|Total of all reporting groups
413352|NCT00962871|B4|Baseline|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
413353|NCT00962871|B3|Baseline|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413354|NCT00962871|B2|Baseline|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413355|NCT00962871|B1|Baseline|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413356|NCT00962871|P4|Participant Flow|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
413357|NCT00962871|P3|Participant Flow|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413358|NCT00962871|P2|Participant Flow|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413359|NCT00962871|P1|Participant Flow|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413360|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
413361|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413362|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413363|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413364|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
413365|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413366|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413367|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413368|NCT00962871|E4|Reported Event|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
413369|NCT00962871|E3|Reported Event|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413370|NCT00962871|E2|Reported Event|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413371|NCT00962871|E1|Reported Event|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
413372|NCT00962780|B3|Baseline|Total|Total of all reporting groups
413373|NCT00962780|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413374|NCT00962780|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413448|NCT00962754|E2|Reported Event|Physician no Insight Fluid Balance Chart|Physician has no insight in the fluid balance chart data (masked)
419221|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
413375|NCT00962780|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413376|NCT00962780|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413377|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413378|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413379|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413380|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413381|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413382|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413383|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413384|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413385|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413386|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413387|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413388|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413389|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413390|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413391|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413392|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413393|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413394|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413395|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413396|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413747|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
413397|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413398|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413399|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413400|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413401|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413402|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413403|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413404|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413405|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413406|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413407|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413408|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413409|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413410|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413411|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413412|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413413|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413414|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413415|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413416|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413417|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413418|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413419|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413420|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413421|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413422|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413423|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413424|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413425|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413426|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413427|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413428|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413429|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413430|NCT00962780|O1|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
413431|NCT00962780|E6|Reported Event|Follow-up|Participants >=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
413432|NCT00962780|E5|Reported Event|23vPS Dose|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
413433|NCT00962780|E4|Reported Event|13vPnC Dose 3|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
413434|NCT00962780|E3|Reported Event|13vPnC Dose 2|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
413435|NCT00962780|E2|Reported Event|13vPnC Dose 1|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
413436|NCT00962780|E1|Reported Event|Prior 13vPnC Dose 1|Participants >=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
413437|NCT00962754|B3|Baseline|Total|Total of all reporting groups
413438|NCT00962754|B2|Baseline|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance data (fluid balance chart is blinded)
413439|NCT00962754|B1|Baseline|Physician Insight Fluid Balance|physician has insight in the fluid balance data
413440|NCT00962754|P2|Participant Flow|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance chart
413441|NCT00962754|P1|Participant Flow|Physician Insight Fluid Balance|Physician has insight in the fluid balance chart
413442|NCT00962754|O2|Outcome|Physician no Insight Fluid Balance Chart|physician has no insight in the fluid balance data (masked)
413443|NCT00962754|O1|Outcome|Physician Insight Fluid Balance|Physician has insight (full access to) in the fluid balance chart data
413444|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|Physician has insight in (full access to) the fluid balance chart data
413445|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in the fluid balance chart data (masked)
413446|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|physician has insight in (full access to) the fluid balance chart data
413447|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in fluid balance chart, ie the fluid balance chart is masked
413449|NCT00962754|E1|Reported Event|Physician Insight Fluid Balance|physician has insight in (full access to) the fluid balance chart data
413450|NCT00962741|B1|Baseline|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413451|NCT00962741|P1|Participant Flow|Etanercept|Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413452|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413453|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413454|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413455|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413456|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413457|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413458|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413459|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413460|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413461|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413462|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413463|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413464|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413465|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413466|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413467|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413468|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413469|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413470|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413471|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413472|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413473|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413474|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413475|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413476|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413477|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413478|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413479|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413480|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413481|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413482|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413483|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413484|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413485|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413486|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413487|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413488|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413489|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413490|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413491|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413492|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413493|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413494|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413495|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413496|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413497|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413498|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413499|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413500|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413501|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413502|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413503|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413504|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413505|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413506|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413507|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413508|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413509|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413510|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413511|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413512|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413513|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413514|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413515|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413516|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413517|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413518|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413519|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413520|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413521|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413522|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413523|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413524|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413525|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413526|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413527|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413528|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413529|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413530|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413531|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413532|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413533|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413534|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413535|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413536|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413537|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413538|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413539|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413540|NCT00962741|E1|Reported Event|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
413541|NCT00962650|B1|Baseline|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
413542|NCT00962650|P1|Participant Flow|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
413543|NCT00962650|O1|Outcome|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
413544|NCT00962650|E1|Reported Event|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
413545|NCT00962598|B3|Baseline|Total|Total of all reporting groups
413546|NCT00962598|B2|Baseline|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
413547|NCT00962598|B1|Baseline|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
413548|NCT00962598|P2|Participant Flow|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
413549|NCT00962598|P1|Participant Flow|Corn Oil|Corn oil: The dosage correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
413550|NCT00962598|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
413551|NCT00962598|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
413552|NCT00962598|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
413553|NCT00962598|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
413554|NCT00962598|E2|Reported Event|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
413555|NCT00962598|E1|Reported Event|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
413556|NCT00962585|B5|Baseline|Total|Total of all reporting groups
413557|NCT00962585|B4|Baseline|Placebo|Placebo treatment arm
413558|NCT00962585|B3|Baseline|S-equol 150 mg BID|300 mg total daily dose of S-equol
413559|NCT00962585|B2|Baseline|S-equol 50 mg BID|100 mg total daily dose of S-equol
413560|NCT00962585|B1|Baseline|S-equol 10 mg BID|20 mg total daily dose of S-equol
413561|NCT00962585|P4|Participant Flow|Placebo|Placebo treatment arm
413562|NCT00962585|P3|Participant Flow|S-equol 150 mg BID|300 mg total daily dose of S-equol
413563|NCT00962585|P2|Participant Flow|S-equol 50 mg BID|100 mg total daily dose of S-equol
413564|NCT00962585|P1|Participant Flow|S-equol 10 mg BID|20 mg total daily dose of S-equol
413565|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
419222|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
413566|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
413567|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413568|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413569|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413570|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413571|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
413572|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
413573|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413574|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413575|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413576|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413577|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413578|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413579|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413580|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413581|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413582|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413583|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413584|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413585|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413586|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413587|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413588|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413589|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413590|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413591|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413592|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413593|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413594|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413595|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413596|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413597|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413598|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413599|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413600|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413601|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413602|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413603|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413604|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413605|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413606|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413607|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413608|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413609|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413610|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413611|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413612|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413613|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
413614|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
413615|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
413616|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
413617|NCT00962585|E4|Reported Event|Placebo|Placebo treatment arm
413618|NCT00962585|E3|Reported Event|S-equol 150 mg BID|300 mg total daily dose of S-equol
413619|NCT00962585|E2|Reported Event|S-equol 50 mg BID|100 mg total daily dose of S-equol
413620|NCT00962585|E1|Reported Event|S-equol 10 mg BID|20 mg total daily dose of S-equol
413621|NCT00962390|B5|Baseline|Total|Total of all reporting groups
413622|NCT00962390|B4|Baseline|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413623|NCT00962390|B3|Baseline|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413624|NCT00962390|B2|Baseline|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413625|NCT00962390|B1|Baseline|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413626|NCT00962390|P4|Participant Flow|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413627|NCT00962390|P3|Participant Flow|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413628|NCT00962390|P2|Participant Flow|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413629|NCT00962390|P1|Participant Flow|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413630|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
419223|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
413631|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413632|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413633|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413634|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413635|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413636|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413637|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413638|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413639|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413640|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413641|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413642|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413643|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413644|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413645|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413646|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413647|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413648|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413649|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413650|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413651|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413652|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413653|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413654|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413655|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413656|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413657|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413658|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413659|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413660|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413661|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413662|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413663|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413664|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413665|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413666|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413667|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413668|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413669|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413670|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413748|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
413671|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413672|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413673|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413674|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413675|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413676|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413677|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413678|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413679|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413680|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413681|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413682|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
413683|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
413684|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
413685|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
413686|NCT00962390|E4|Reported Event|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
413687|NCT00962390|E3|Reported Event|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
413688|NCT00962390|E2|Reported Event|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
413689|NCT00962390|E1|Reported Event|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
413690|NCT00962247|B1|Baseline|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
413691|NCT00962247|P1|Participant Flow|Sedentary; Usual, 25% Reduced, 50% Reduced|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
413692|NCT00962247|O3|Outcome|50% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 50% from the usual sedentary condition using a television reduction device (TV Allowance)~Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
413693|NCT00962247|O2|Outcome|25% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 25% from the usual sedentary condition using a television reduction device (TV Allowance)~Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
413694|NCT00962247|O1|Outcome|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
413695|NCT00962247|O3|Outcome|50% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 50% from the usual sedentary condition using a television reduction device (TV Allowance)~Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
413696|NCT00962247|O2|Outcome|25% Sedentary Reduction|"Children were asked to reduce their targeted sedentary behaviors (TV, video game, computer use) by 25% from the usual sedentary condition using a television reduction device (TV Allowance)~Television reduction device: A TV allowance helps turn off the television when the time limits have been met."
413697|NCT00962247|O1|Outcome|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
413698|NCT00962247|E1|Reported Event|Usual Sedentary|Children were asked to maintain their usual targeted sedentary behaviors (TV, video game, computer use) measured by a television reduction device (TV Allowance)
413699|NCT00962208|B3|Baseline|Total|Total of all reporting groups
413700|NCT00962208|B2|Baseline|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
413701|NCT00962208|B1|Baseline|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
413702|NCT00962208|P2|Participant Flow|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
413749|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413703|NCT00962208|P1|Participant Flow|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
413704|NCT00962208|O2|Outcome|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
413705|NCT00962208|O1|Outcome|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
413706|NCT00962208|E2|Reported Event|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
413707|NCT00962208|E1|Reported Event|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
413708|NCT00962104|B3|Baseline|Total|Total of all reporting groups
413709|NCT00962104|B2|Baseline|Placebo|Taken by mouth, once daily for 10 weeks.
413710|NCT00962104|B1|Baseline|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413711|NCT00962104|P2|Participant Flow|Placebo|Taken by mouth, once daily for 10 weeks.
413712|NCT00962104|P1|Participant Flow|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413713|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413714|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413715|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413716|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413717|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413718|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413719|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413720|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413721|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413722|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413723|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413724|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413725|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413726|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413727|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413728|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413729|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413730|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413731|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413732|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413733|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
413734|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413735|NCT00962104|E2|Reported Event|Placebo|Taken by mouth, once daily for 10 weeks.
413736|NCT00962104|E1|Reported Event|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
413737|NCT00962065|B4|Baseline|Total|Total of all reporting groups
413738|NCT00962065|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake for 28 days
413739|NCT00962065|B2|Baseline|High Dose|A high dose of LX4211; daily oral intake for 28 days
413740|NCT00962065|B1|Baseline|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413741|NCT00962065|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 28 days
413742|NCT00962065|P2|Participant Flow|High Dose|A high dose of LX4211; daily oral intake for 28 days
413743|NCT00962065|P1|Participant Flow|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413744|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
413745|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
413746|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413756|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
413757|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
413758|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413759|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
413760|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
413761|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413762|NCT00962065|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 28 days
413763|NCT00962065|E2|Reported Event|High Dose|A high dose of LX4211; daily oral intake for 28 days
413764|NCT00962065|E1|Reported Event|Low Dose|A low dose of LX4211; daily oral intake for 28 days
413765|NCT00962013|B1|Baseline|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413766|NCT00962013|P1|Participant Flow|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413767|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413768|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413769|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413770|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413771|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413772|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413773|NCT00962013|E1|Reported Event|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
413774|NCT00962000|B1|Baseline|All Study Participants|All subjects who participated in the study.
413775|NCT00962000|P2|Participant Flow|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
413776|NCT00962000|P1|Participant Flow|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
413777|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
413778|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
413779|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
413780|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
413781|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
413782|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
413783|NCT00962000|E2|Reported Event|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
413784|NCT00962000|E1|Reported Event|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
413785|NCT00961896|B4|Baseline|Total|Total of all reporting groups
413786|NCT00961896|B3|Baseline|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
413787|NCT00961896|B2|Baseline|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
413788|NCT00961896|B1|Baseline|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
413789|NCT00961896|P3|Participant Flow|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
413790|NCT00961896|P2|Participant Flow|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
413791|NCT00961896|P1|Participant Flow|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
413792|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
413793|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
413948|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
413794|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
413795|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
413796|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
413797|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
413798|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
413799|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
413800|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
413801|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
413802|NCT00961896|O4|Outcome|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
413803|NCT00961896|O3|Outcome|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
413804|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
413805|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
413806|NCT00961896|E3|Reported Event|0.75% LDE225 [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
413807|NCT00961896|E2|Reported Event|0.25% LDE225 [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
413808|NCT00961896|E1|Reported Event|All Part I Participants|Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
413809|NCT00961805|B3|Baseline|Total|Total of all reporting groups
413810|NCT00961805|B2|Baseline|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home
413811|NCT00961805|B1|Baseline|Group Control|The waiting list
413812|NCT00961805|P2|Participant Flow|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413813|NCT00961805|P1|Participant Flow|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413814|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413815|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413816|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413817|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413818|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413819|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413820|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413821|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413822|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413823|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413824|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413825|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413826|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413827|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413828|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413829|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413830|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413831|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413832|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413833|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
419224|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
413834|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413835|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413836|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413837|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413838|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
413839|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
413840|NCT00961662|B4|Baseline|Total|Total of all reporting groups
413841|NCT00961662|B3|Baseline|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413842|NCT00961662|B2|Baseline|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
413843|NCT00961662|B1|Baseline|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413844|NCT00961662|P3|Participant Flow|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413845|NCT00961662|P2|Participant Flow|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
413846|NCT00961662|P1|Participant Flow|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413847|NCT00961662|O3|Outcome|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413848|NCT00961662|O2|Outcome|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
413849|NCT00961662|O1|Outcome|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413850|NCT00961662|E3|Reported Event|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413851|NCT00961662|E2|Reported Event|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
413852|NCT00961662|E1|Reported Event|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
413853|NCT00961649|B5|Baseline|Total|Total of all reporting groups
413854|NCT00961649|B4|Baseline|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413855|NCT00961649|B3|Baseline|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413856|NCT00961649|B2|Baseline|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413857|NCT00961649|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413858|NCT00961649|P4|Participant Flow|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413859|NCT00961649|P3|Participant Flow|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413860|NCT00961649|P2|Participant Flow|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413861|NCT00961649|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413862|NCT00961649|O2|Outcome|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413863|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413864|NCT00961649|O3|Outcome|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413865|NCT00961649|O2|Outcome|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413866|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413867|NCT00961649|E4|Reported Event|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413868|NCT00961649|E3|Reported Event|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413869|NCT00961649|E2|Reported Event|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413870|NCT00961649|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
413871|NCT00961636|B4|Baseline|Total|Total of all reporting groups
413872|NCT00961636|B3|Baseline|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
413873|NCT00961636|B2|Baseline|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
413874|NCT00961636|B1|Baseline|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
413875|NCT00961636|P3|Participant Flow|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
413876|NCT00961636|P2|Participant Flow|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
413877|NCT00961636|P1|Participant Flow|ERN/LRPT|One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
413878|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
413879|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
413880|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
413881|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
413882|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
413883|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
413884|NCT00961636|E3|Reported Event|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
413885|NCT00961636|E2|Reported Event|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
413886|NCT00961636|E1|Reported Event|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
413887|NCT00961571|B1|Baseline|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
413888|NCT00961571|P1|Participant Flow|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
413889|NCT00961571|O1|Outcome|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
413890|NCT00961571|E1|Reported Event|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
413891|NCT00961532|B1|Baseline|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
413892|NCT00961532|P1|Participant Flow|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
413893|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
413894|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
413895|NCT00961532|E1|Reported Event|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
413896|NCT00961441|B3|Baseline|Total|Total of all reporting groups
413897|NCT00961441|B2|Baseline|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413898|NCT00961441|B1|Baseline|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413899|NCT00961441|P2|Participant Flow|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413900|NCT00961441|P1|Participant Flow|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413901|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413902|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413903|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413904|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413905|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413906|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413907|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413908|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413909|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413910|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413911|NCT00961441|E2|Reported Event|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413912|NCT00961441|E1|Reported Event|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
413913|NCT00961415|B3|Baseline|Total|Total of all reporting groups
413914|NCT00961415|B2|Baseline|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413915|NCT00961415|B1|Baseline|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413916|NCT00961415|P3|Participant Flow|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413917|NCT00961415|P2|Participant Flow|Bevacizumab Maintenance Treatment (Trt) Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413918|NCT00961415|P1|Participant Flow|Induction Treatment Phase|Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m^2 + pemetrexed 500 mg/m^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy.
413919|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 mcg daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413920|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy
413921|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm...
413922|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
413923|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
413924|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
413925|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis.
413926|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
413947|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
413927|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413928|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413929|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413930|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413931|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413932|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413933|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413934|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413935|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413936|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
413937|NCT00961415|E3|Reported Event|Maintenance Treatment Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
413938|NCT00961415|E2|Reported Event|Maintenance Treatment Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis
413939|NCT00961415|E1|Reported Event|No Maintenance Treatment|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm..
413940|NCT00961402|B3|Baseline|Total|Total of all reporting groups
413941|NCT00961402|B2|Baseline|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
413942|NCT00961402|B1|Baseline|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
413943|NCT00961402|P2|Participant Flow|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
413944|NCT00961402|P1|Participant Flow|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
413945|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
413946|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
413949|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
413950|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
413951|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
413952|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
413953|NCT00961402|E2|Reported Event|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
413954|NCT00961402|E1|Reported Event|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
413955|NCT00961350|B3|Baseline|Total|Total of all reporting groups
413956|NCT00961350|B2|Baseline|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413957|NCT00961350|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413958|NCT00961350|P2|Participant Flow|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413959|NCT00961350|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413960|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413961|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413962|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413963|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413964|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413965|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413966|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413967|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413968|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413969|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413970|NCT00961350|E2|Reported Event|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
413971|NCT00961350|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
413972|NCT00961311|B1|Baseline|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
413973|NCT00961311|P1|Participant Flow|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
413974|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
413975|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
413976|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
413977|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
413978|NCT00961311|E1|Reported Event|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
413979|NCT00961298|B1|Baseline|Treatment Arm|every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
413980|NCT00961298|P1|Participant Flow|Treatment Arm|Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
413981|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
413982|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
413983|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
413984|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
413985|NCT00961298|E1|Reported Event|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
414049|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
414467|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
413986|NCT00961259|B1|Baseline|Fenofibric Acid - Treatments A, B and C|All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).
413987|NCT00961259|P3|Participant Flow|Treatment Sequence CAB|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).
413988|NCT00961259|P2|Participant Flow|Treatment Sequence BCA|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
413989|NCT00961259|P1|Participant Flow|Treatment Sequence ABC|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
413990|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
413991|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
413992|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
413993|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
413994|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
413995|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
413996|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
413997|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
413998|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
413999|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
414000|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
414001|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
414002|NCT00961259|E3|Reported Event|Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
414003|NCT00961259|E2|Reported Event|Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B|Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
414004|NCT00961259|E1|Reported Event|Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
414005|NCT00961233|B3|Baseline|Total|Total of all reporting groups
414006|NCT00961233|B2|Baseline|Viscous/Swallowed Budesonide|
414007|NCT00961233|B1|Baseline|Inhaled/Swallowed Budesonide|
414008|NCT00961233|P2|Participant Flow|Viscous/Swallowed Budesonide|viscous/swallowed budesonide - budesonide slurry (created with 5g sucralose) 1 mg twice daily that is swallowed
414009|NCT00961233|P1|Participant Flow|Inhaled/Swallowed Budesonide|inhaled/swallowed budesonide - nebulized budesonide 1mg twice daily that is swallowed.
414010|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|viscous slurry of budesonide and sucralose 1 mg twice daily
414011|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|nebulized then swallowed budesonide 1mg twice daily
414012|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|
414013|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|
414014|NCT00961233|E2|Reported Event|Viscous/Swallowed Budesonide|
414015|NCT00961233|E1|Reported Event|Inhaled/Swallowed Budesonide|
414016|NCT00961220|B1|Baseline|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414047|NCT00961116|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast.
419225|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
414017|NCT00961220|P1|Participant Flow|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414018|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414019|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414020|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414021|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414022|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414023|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414024|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414025|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414026|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414048|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
414099|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414027|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414028|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414029|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414030|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV~carmustine: Applied topically~laboratory biomarker analysis: Correlative studies"
414031|NCT00961220|E1|Reported Event|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
414032|NCT00961181|B1|Baseline|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414033|NCT00961181|P1|Participant Flow|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414034|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414035|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414036|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414037|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414038|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414039|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414040|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414041|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414042|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414043|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414044|NCT00961181|E1|Reported Event|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
414045|NCT00961116|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg following an overnight fast.
414046|NCT00961116|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, after an overnight fast.
414468|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414050|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
414051|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
414052|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
414053|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
414054|NCT00961116|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
414055|NCT00961116|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours.
414056|NCT00961051|B3|Baseline|Total|Total of all reporting groups
414057|NCT00961051|B2|Baseline|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
414058|NCT00961051|B1|Baseline|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
414059|NCT00961051|P2|Participant Flow|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
414060|NCT00961051|P1|Participant Flow|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
414061|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
414062|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
414063|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
414064|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
414065|NCT00961051|E2|Reported Event|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
414066|NCT00961051|E1|Reported Event|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
414067|NCT00960999|B3|Baseline|Total|Total of all reporting groups
414068|NCT00960999|B2|Baseline|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
414069|NCT00960999|B1|Baseline|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
414070|NCT00960999|P2|Participant Flow|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
414071|NCT00960999|P1|Participant Flow|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
414072|NCT00960999|O2|Outcome|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
414073|NCT00960999|O1|Outcome|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
414074|NCT00960999|E2|Reported Event|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
414075|NCT00960999|E1|Reported Event|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
414076|NCT00960986|B5|Baseline|Total|Total of all reporting groups
414077|NCT00960986|B4|Baseline|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414078|NCT00960986|B3|Baseline|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414079|NCT00960986|B2|Baseline|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414080|NCT00960986|B1|Baseline|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414081|NCT00960986|P4|Participant Flow|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414082|NCT00960986|P3|Participant Flow|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414083|NCT00960986|P2|Participant Flow|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414084|NCT00960986|P1|Participant Flow|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414085|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414086|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414087|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414088|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414089|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414090|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414091|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414092|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414093|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414094|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414095|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414096|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414097|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414098|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414100|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414101|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414102|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414103|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414104|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414105|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414106|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414107|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414108|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414109|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414110|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414111|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414112|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414113|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414114|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414115|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414116|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414117|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414118|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414119|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414120|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414121|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414122|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414123|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414124|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414125|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414126|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414127|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414128|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414129|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414130|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414131|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414132|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414133|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414134|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414135|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414136|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414137|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414138|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414139|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414140|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414141|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414142|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414143|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414144|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414145|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414146|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414147|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
419226|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
414148|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414149|NCT00960986|E4|Reported Event|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
414150|NCT00960986|E3|Reported Event|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
414151|NCT00960986|E2|Reported Event|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
414152|NCT00960986|E1|Reported Event|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
414153|NCT00960934|B7|Baseline|Total|Total of all reporting groups
414154|NCT00960934|B6|Baseline|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414155|NCT00960934|B5|Baseline|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414156|NCT00960934|B4|Baseline|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414157|NCT00960934|B3|Baseline|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414158|NCT00960934|B2|Baseline|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414159|NCT00960934|B1|Baseline|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414160|NCT00960934|P6|Participant Flow|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414161|NCT00960934|P5|Participant Flow|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414162|NCT00960934|P4|Participant Flow|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414163|NCT00960934|P3|Participant Flow|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414164|NCT00960934|P2|Participant Flow|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414165|NCT00960934|P1|Participant Flow|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414166|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414167|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414168|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414169|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414170|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414171|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414172|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414173|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414174|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414175|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414176|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414177|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414178|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414179|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414180|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414181|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414182|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414183|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414184|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414185|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414186|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414187|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414188|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414189|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414190|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414191|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414192|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414193|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414194|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414195|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414196|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414197|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414198|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414199|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414200|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414201|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414202|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414203|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414204|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414205|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414206|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414207|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414208|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414209|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414210|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414211|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414212|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414213|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414214|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414215|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414216|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414217|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414218|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414219|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414220|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414221|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414332|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
414222|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414223|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414224|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414225|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414226|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414227|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414228|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414229|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414230|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414231|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414232|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414233|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414234|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414235|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414236|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414237|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414238|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414239|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414240|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414241|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414242|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414243|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414244|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414245|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414246|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414247|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414248|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414249|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414250|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414251|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414252|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414253|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414254|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414255|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414256|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414257|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414607|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414258|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414259|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414260|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414261|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414262|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414263|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414264|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414265|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414266|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414267|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414268|NCT00960934|E6|Reported Event|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
414269|NCT00960934|E5|Reported Event|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
414270|NCT00960934|E4|Reported Event|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
414271|NCT00960934|E3|Reported Event|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
414272|NCT00960934|E2|Reported Event|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
414273|NCT00960934|E1|Reported Event|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
414274|NCT00960869|B3|Baseline|Total|Total of all reporting groups
414275|NCT00960869|B2|Baseline|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414276|NCT00960869|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414277|NCT00960869|P2|Participant Flow|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414278|NCT00960869|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414279|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414280|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414281|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414282|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414283|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414284|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414285|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414286|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414287|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414288|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414289|NCT00960869|E2|Reported Event|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
414290|NCT00960869|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
414291|NCT00960856|B1|Baseline|Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted|All subjects received each of the four study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8, 15 and 22 each subject received one tablet of fenofibric acid 105 mg administered after one of the following meal conditions: 1) low-fat meal, 2) standard meal, 3) high-fat/high-calorie meal 4) overnight fast of at least 10 hours.
414292|NCT00960856|P4|Participant Flow|Sequence DABC|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
414293|NCT00960856|P3|Participant Flow|Sequence CDAB|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
414294|NCT00960856|P2|Participant Flow|Sequence BCDA|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
414333|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
414295|NCT00960856|P1|Participant Flow|Sequence ABCD|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
414296|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
414297|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
414298|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
414299|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
414300|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
414301|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
414302|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
414303|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
414304|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
414305|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
414306|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
414307|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
414308|NCT00960856|E4|Reported Event|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours.
414309|NCT00960856|E3|Reported Event|High-fat, High-calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
414310|NCT00960856|E2|Reported Event|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
414311|NCT00960856|E1|Reported Event|Low-Fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
414312|NCT00960843|B3|Baseline|Total|Total of all reporting groups
414313|NCT00960843|B2|Baseline|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
414314|NCT00960843|B1|Baseline|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
414315|NCT00960843|P2|Participant Flow|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
414316|NCT00960843|P1|Participant Flow|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
414317|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
414318|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
414319|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
414320|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
414321|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
414322|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
414323|NCT00960843|E2|Reported Event|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
414324|NCT00960843|E1|Reported Event|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
414325|NCT00960687|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg, 30 minutes after the initiation of a standard meal.
414326|NCT00960687|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast.
414327|NCT00960687|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast.
414328|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
414329|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
414330|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
414331|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
419227|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
414334|NCT00960687|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg 30 minutes after the initiation of a standard breakfast.
414335|NCT00960687|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg 30 minutes after the initiation of a standard breakfast.
414336|NCT00960661|B3|Baseline|Total|Total of all reporting groups
414337|NCT00960661|B2|Baseline|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414338|NCT00960661|B1|Baseline|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414339|NCT00960661|P3|Participant Flow|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414340|NCT00960661|P2|Participant Flow|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414341|NCT00960661|P1|Participant Flow|Enrolled|Patients who enrolled in the basal insulin optimization (BIO) phase
414342|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414343|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414344|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414345|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414346|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414347|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414348|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414349|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414350|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414351|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414352|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414353|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414354|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414355|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414356|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414357|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414358|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414359|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414360|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414361|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414362|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414363|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414364|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414365|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414366|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414367|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414368|NCT00960661|E2|Reported Event|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
414369|NCT00960661|E1|Reported Event|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
414370|NCT00960622|B3|Baseline|Total|Total of all reporting groups
414371|NCT00960622|B2|Baseline|Combivir, Trizivir.|continue on Combivir, trizivir.
414372|NCT00960622|B1|Baseline|Truvada|switch from Combivir to Truvada
414373|NCT00960622|P2|Participant Flow|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.
414374|NCT00960622|P1|Participant Flow|Truvada 200/300 mg, Daily, by Mouth.|The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.
414375|NCT00960622|O2|Outcome|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
414376|NCT00960622|O1|Outcome|Truvada 200/300 mg, Daily, by Mouth.|switch from Combivir or trizivir to Truvada 200/300 mg, daily, by mouth.
414377|NCT00960622|E2|Reported Event|Combivir, Trizivir.|continue on Combivir, trizivir.
414378|NCT00960622|E1|Reported Event|Truvada|switch from Combivir to Truvada
414379|NCT00960570|B1|Baseline|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
414380|NCT00960570|P1|Participant Flow|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
414381|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
414382|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
414383|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
414384|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
414385|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
414386|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
414387|NCT00960570|E3|Reported Event|Efavirenz and Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
414388|NCT00960570|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
414389|NCT00960570|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
414390|NCT00960531|B11|Baseline|Total|Total of all reporting groups
414391|NCT00960531|B10|Baseline|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414392|NCT00960531|B9|Baseline|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414393|NCT00960531|B8|Baseline|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414394|NCT00960531|B7|Baseline|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414395|NCT00960531|B6|Baseline|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414396|NCT00960531|B5|Baseline|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414397|NCT00960531|B4|Baseline|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414398|NCT00960531|B3|Baseline|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414399|NCT00960531|B2|Baseline|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414400|NCT00960531|B1|Baseline|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414401|NCT00960531|P10|Participant Flow|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414402|NCT00960531|P9|Participant Flow|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414403|NCT00960531|P8|Participant Flow|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414404|NCT00960531|P7|Participant Flow|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414405|NCT00960531|P6|Participant Flow|PBS / ACC 10 µg+QS-21|Participants received Phosphate buffered Saline (PBS) in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414406|NCT00960531|P5|Participant Flow|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414407|NCT00960531|P4|Participant Flow|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414408|NCT00960531|P3|Participant Flow|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414409|NCT00960531|P2|Participant Flow|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414608|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414410|NCT00960531|P1|Participant Flow|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414411|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414412|NCT00960531|O9|Outcome|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414413|NCT00960531|O8|Outcome|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414414|NCT00960531|O7|Outcome|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414415|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414416|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414417|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414418|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414419|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414420|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414421|NCT00960531|O6|Outcome|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414422|NCT00960531|O5|Outcome|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414423|NCT00960531|O4|Outcome|Control / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414424|NCT00960531|O3|Outcome|Active / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414425|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414426|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414427|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414428|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414429|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414430|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414431|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414432|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414433|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414434|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414466|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414435|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414436|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414437|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414438|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414439|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414440|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414441|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414442|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414443|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414444|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414445|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414446|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414447|NCT00960531|E6|Reported Event|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414448|NCT00960531|E5|Reported Event|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414449|NCT00960531|E4|Reported Event|Control / ACC 10µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414450|NCT00960531|E3|Reported Event|Active / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414451|NCT00960531|E2|Reported Event|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414452|NCT00960531|E1|Reported Event|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
414453|NCT00960440|B5|Baseline|Total|Total of all reporting groups
414454|NCT00960440|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414455|NCT00960440|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414456|NCT00960440|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414457|NCT00960440|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414458|NCT00960440|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414459|NCT00960440|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414460|NCT00960440|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414461|NCT00960440|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
414462|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414463|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414464|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414465|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414469|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414470|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414471|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414472|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414473|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414474|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414475|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414476|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414477|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414478|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414479|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414480|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414481|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414482|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414483|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414484|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414485|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414486|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414487|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414488|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414489|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414490|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414491|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414492|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414493|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414494|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414495|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414496|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414497|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414498|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414499|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414500|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414501|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414502|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414503|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414504|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414505|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414506|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414507|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414508|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414509|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414510|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414511|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414512|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414513|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414514|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
419228|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
414515|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414516|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414517|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414518|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414519|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414520|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414521|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414522|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414523|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414524|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414525|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414526|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414527|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414528|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414529|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414530|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414531|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414532|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414533|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414534|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414535|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414536|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414537|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414538|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414539|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414540|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414541|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414542|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414543|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414544|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414545|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414546|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414547|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414548|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414549|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414550|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414551|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414552|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414553|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414554|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414555|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414556|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414557|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414558|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414559|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414560|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
419229|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
414561|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414562|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414563|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414564|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414565|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414566|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414567|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414568|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414569|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414570|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414571|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414572|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414573|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414574|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414575|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414576|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414577|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414578|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414579|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414580|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414581|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414582|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414583|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414584|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414585|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414586|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414587|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414588|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414589|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414590|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414591|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414592|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414593|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414594|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414595|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414596|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414597|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414598|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414599|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414600|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414601|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414602|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414603|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414604|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414605|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414606|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
419230|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
414609|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
414610|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
414611|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414612|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414613|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414614|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414615|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414616|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414617|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414618|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414619|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414620|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414621|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414622|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
414623|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
414624|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
414625|NCT00960440|E5|Reported Event|CP-690,550 10 mg From Month 3 to 6|CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.
414626|NCT00960440|E4|Reported Event|CP-690,550 5 mg From Month 3 to 6|CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
414627|NCT00960440|E3|Reported Event|Placebo Up to Month 3|Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
414628|NCT00960440|E2|Reported Event|CP-690,550 10 mg Up to Month 3|CP-690,550 10 mg tablets orally twice daily up to Month 3.
414629|NCT00960440|E1|Reported Event|CP-690,550 5 mg Up to Month 3|CP-690,550 5 mg tablet orally twice daily up to Month 3.
414630|NCT00960375|B3|Baseline|Total|Total of all reporting groups
414631|NCT00960375|B2|Baseline|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
414632|NCT00960375|B1|Baseline|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
414633|NCT00960375|P2|Participant Flow|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
414634|NCT00960375|P1|Participant Flow|BTSCS|BTSCS includes two 60-minute groups/week (24 total). It is delivered in groups of 4-8 participants run by a trained interventionist. It includes: (1) individual motivational enhancement session to help participants think about personal reasons for change; (2) Breath CO monitoring and goal-setting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about negative health effects of smoking; (5) Relapse prevention; (6) Education about and assistance with nicotine replacement therapy.
414635|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
414636|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
414637|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
414638|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
414639|NCT00960375|E2|Reported Event|StSST|The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups provide education about smoking and support for quitting. Smoking education groups involve weekly (24 groups total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
414640|NCT00960375|E1|Reported Event|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
414641|NCT00960323|B1|Baseline|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
414642|NCT00960323|P1|Participant Flow|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
414643|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
414644|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
414645|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
414646|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
414647|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
414648|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast followed by a 14 day washout period.
414649|NCT00960323|E3|Reported Event|Colchicine and Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
414650|NCT00960323|E2|Reported Event|Atorvastatin Alone|On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast.
414651|NCT00960323|E1|Reported Event|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
414652|NCT00960297|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
414653|NCT00960297|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
414654|NCT00960297|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
414655|NCT00960297|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
414656|NCT00960206|B4|Baseline|Total|Total of all reporting groups
414657|NCT00960206|B3|Baseline|Control|Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell
414658|NCT00960206|B2|Baseline|ABC System|Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell
414659|NCT00960206|B1|Baseline|Trident System|Trident Ceramic Insert/Trident AD with PureFix HA Shell
414660|NCT00960206|P3|Participant Flow|Control|Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
414661|NCT00960206|P2|Participant Flow|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
414662|NCT00960206|P1|Participant Flow|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
414663|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
414664|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
414665|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
414666|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
414667|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
414668|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
414669|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
414670|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
414671|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
414672|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
414673|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
414674|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
414675|NCT00960206|E4|Reported Event|All Participants|All participants combined.
414676|NCT00960206|E3|Reported Event|Control|Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
414677|NCT00960206|E2|Reported Event|ABC System|Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
414678|NCT00960206|E1|Reported Event|Trident® System|Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
414679|NCT00960193|B1|Baseline|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
414680|NCT00960193|P1|Participant Flow|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
414681|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
414682|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
414683|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
414684|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
414685|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
414686|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
414750|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
414687|NCT00960193|E3|Reported Event|Colchicine With Seville Orange Juice|On Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
414688|NCT00960193|E2|Reported Event|Seville Orange Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening.
414689|NCT00960193|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at after an overnight fast, followed by a washout period of 14 days.
414690|NCT00960154|B3|Baseline|Total|Total of all reporting groups
414691|NCT00960154|B2|Baseline|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
414692|NCT00960154|B1|Baseline|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
414693|NCT00960154|P2|Participant Flow|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
414694|NCT00960154|P1|Participant Flow|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
414695|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
414696|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
414697|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
414698|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
414699|NCT00960154|E2|Reported Event|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
414700|NCT00960154|E1|Reported Event|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
414701|NCT00960141|B4|Baseline|Total|Total of all reporting groups
414702|NCT00960141|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414703|NCT00960141|B2|Baseline|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414704|NCT00960141|B1|Baseline|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414705|NCT00960141|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414706|NCT00960141|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414707|NCT00960141|P1|Participant Flow|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414708|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414709|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414710|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414711|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414712|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414713|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414714|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414715|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414716|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414717|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414718|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414719|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414720|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414721|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414722|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414723|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414724|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414725|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414726|NCT00960141|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
414727|NCT00960141|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
414728|NCT00960141|E1|Reported Event|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
414729|NCT00960115|B3|Baseline|Total|Total of all reporting groups
414749|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
414730|NCT00960115|B2|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
414731|NCT00960115|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
414732|NCT00960115|P2|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
414733|NCT00960115|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented.
414734|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
414735|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
414736|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
414737|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
414738|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
414739|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
414740|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
414741|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
414742|NCT00960115|E2|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
414743|NCT00960115|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
414744|NCT00960076|B3|Baseline|Total|Total of all reporting groups
414745|NCT00960076|B2|Baseline|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
414746|NCT00960076|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
414747|NCT00960076|P2|Participant Flow|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
414748|NCT00960076|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
414751|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
414752|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
414753|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
414754|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
414755|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
414756|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
414757|NCT00960076|E2|Reported Event|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
414758|NCT00960076|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
414759|NCT00960063|B4|Baseline|Total|Total of all reporting groups
414760|NCT00960063|B3|Baseline|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414761|NCT00960063|B2|Baseline|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414762|NCT00960063|B1|Baseline|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414763|NCT00960063|P3|Participant Flow|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414764|NCT00960063|P2|Participant Flow|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414765|NCT00960063|P1|Participant Flow|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414766|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414767|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414768|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414769|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414770|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414771|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414772|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414773|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414774|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414775|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414776|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414777|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414778|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414779|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414780|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414781|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
419231|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
414782|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414783|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414784|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414785|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414786|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414787|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414788|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414789|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414790|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414791|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414792|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414793|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414794|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414795|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414796|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414797|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414798|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414799|NCT00960063|E3|Reported Event|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414800|NCT00960063|E2|Reported Event|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414801|NCT00960063|E1|Reported Event|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
414802|NCT00959985|B5|Baseline|Total|Total of all reporting groups
414803|NCT00959985|B4|Baseline|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414804|NCT00959985|B3|Baseline|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414805|NCT00959985|B2|Baseline|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414806|NCT00959985|B1|Baseline|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414807|NCT00959985|P4|Participant Flow|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414808|NCT00959985|P3|Participant Flow|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414809|NCT00959985|P2|Participant Flow|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414810|NCT00959985|P1|Participant Flow|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
419232|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
414811|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414812|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414813|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414814|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414815|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414816|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414817|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414818|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414819|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414820|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414821|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414822|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414823|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414824|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414825|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414826|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414827|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414828|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414829|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414830|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414831|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414832|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414833|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414834|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414835|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414836|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414837|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414838|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414839|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414840|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414841|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414842|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414843|NCT00959985|E4|Reported Event|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
414844|NCT00959985|E3|Reported Event|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414845|NCT00959985|E2|Reported Event|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
414846|NCT00959985|E1|Reported Event|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
414847|NCT00959946|B9|Baseline|Total|Total of all reporting groups
414848|NCT00959946|B8|Baseline|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414983|NCT00959764|E1|Reported Event|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
414849|NCT00959946|B7|Baseline|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414850|NCT00959946|B6|Baseline|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414851|NCT00959946|B5|Baseline|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414852|NCT00959946|B4|Baseline|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414853|NCT00959946|B3|Baseline|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414854|NCT00959946|B2|Baseline|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414855|NCT00959946|B1|Baseline|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
414856|NCT00959946|P8|Participant Flow|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414857|NCT00959946|P7|Participant Flow|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414858|NCT00959946|P6|Participant Flow|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414859|NCT00959946|P5|Participant Flow|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414860|NCT00959946|P4|Participant Flow|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414861|NCT00959946|P3|Participant Flow|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414862|NCT00959946|P2|Participant Flow|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414863|NCT00959946|P1|Participant Flow|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
414864|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414865|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414866|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414984|NCT00959751|B3|Baseline|Total|Total of all reporting groups
414985|NCT00959751|B2|Baseline|Placebo|3 x 0 mg capsules
414867|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414868|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414869|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414870|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414871|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414872|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414873|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414874|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414875|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414876|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414877|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414878|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414879|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414897|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414986|NCT00959751|B1|Baseline|NXN-188|3 x 200 mg capsules
414880|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414881|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414882|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414883|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414884|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414885|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414886|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414887|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414888|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414889|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414890|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414891|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
414892|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
414893|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
414894|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414895|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414896|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414981|NCT00959764|E3|Reported Event|Placebo|Patients who did not receive any active treatment
414898|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414899|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414900|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414901|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
414902|NCT00959946|O3|Outcome|Bosutinib + Capecitabine 1000 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 1000 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414903|NCT00959946|O2|Outcome|Bosutinib + Capecitabine 750 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 750 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414904|NCT00959946|O1|Outcome|Bosutinib + Capecitabine 625 mg/m^2|Bosutinib 200 mg, or 300 mg, tablet administered orally once daily in a 21-day cycle. Capecitabine 625 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414905|NCT00959946|E8|Reported Event|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414906|NCT00959946|E7|Reported Event|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414907|NCT00959946|E6|Reported Event|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414908|NCT00959946|E5|Reported Event|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414909|NCT00959946|E4|Reported Event|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414910|NCT00959946|E3|Reported Event|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414911|NCT00959946|E2|Reported Event|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
414912|NCT00959946|E1|Reported Event|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
414913|NCT00959920|B3|Baseline|Total|Total of all reporting groups
414914|NCT00959920|B2|Baseline|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
414915|NCT00959920|B1|Baseline|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
414916|NCT00959920|P2|Participant Flow|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
414917|NCT00959920|P1|Participant Flow|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
414918|NCT00959920|O2|Outcome|Intermittent Straight Catheterization|"Intermittent straight catheterization will be performed as needed during labor.~Intermittent straight catheterization: intermittent straight catheterization will be performed on an as needed basis until time of delivery."
414919|NCT00959920|O1|Outcome|Indwelling Foley Catheter|"Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.~Indwelling catheter: Indwelling bladder catheter will remain in place until time of delivery."
414920|NCT00959920|O2|Outcome|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
414982|NCT00959764|E2|Reported Event|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
414921|NCT00959920|O1|Outcome|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
414922|NCT00959920|E2|Reported Event|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
414923|NCT00959920|E1|Reported Event|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
414924|NCT00959907|B3|Baseline|Total|Total of all reporting groups
414925|NCT00959907|B2|Baseline|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
414926|NCT00959907|B1|Baseline|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
414927|NCT00959907|P2|Participant Flow|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
414928|NCT00959907|P1|Participant Flow|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
414929|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
414930|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
414931|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
414932|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
414933|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
414934|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
414935|NCT00959907|E2|Reported Event|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
414936|NCT00959907|E1|Reported Event|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
414937|NCT00959894|B1|Baseline|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414938|NCT00959894|P1|Participant Flow|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414939|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day~Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414940|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day~Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414941|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414942|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414943|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414944|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414945|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414946|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414947|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414948|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414949|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414950|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414951|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414952|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414953|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414954|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414955|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414956|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414957|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414958|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414959|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414960|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414961|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414962|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414963|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414964|NCT00959894|E1|Reported Event|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
414965|NCT00959764|B4|Baseline|Total|Total of all reporting groups
414966|NCT00959764|B3|Baseline|Placebo|Patients who did not receive any active treatment
414967|NCT00959764|B2|Baseline|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
414968|NCT00959764|B1|Baseline|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
414969|NCT00959764|P3|Participant Flow|Placebo|Patients who did not receive any active treatment
414970|NCT00959764|P2|Participant Flow|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
414971|NCT00959764|P1|Participant Flow|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
414972|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
414973|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
414974|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
414975|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
414976|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
414977|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
414978|NCT00959764|O3|Outcome|Placebo|Patients who were provided nasal and oral placebo medication in a blinded fashion
414979|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
414980|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
414987|NCT00959751|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules, PRN
414988|NCT00959751|P1|Participant Flow|Placebo|3 x capsules, PRN
414989|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
414990|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
414991|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
414992|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
414993|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
414994|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
414995|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
414996|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
414997|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
414998|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
414999|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
415000|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
415001|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
415002|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
415003|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
415004|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
415005|NCT00959751|E2|Reported Event|Placebo|3 x 0 mg capsules, PRN
415006|NCT00959751|E1|Reported Event|NXN-188 600 mg|3 x 200 mg capsules, PRN
415007|NCT00959699|B3|Baseline|Total|Total of all reporting groups
415008|NCT00959699|B2|Baseline|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415009|NCT00959699|B1|Baseline|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415010|NCT00959699|P2|Participant Flow|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415011|NCT00959699|P1|Participant Flow|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415012|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415013|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415014|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415015|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415016|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415017|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415018|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415019|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415020|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415021|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415181|NCT00958919|B1|Baseline|Entire Study Population|Includes groups randomized to receive saline first and Naxolone first.
415022|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415023|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415024|NCT00959699|E3|Reported Event|Boceprevir Crossover|(After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
415025|NCT00959699|E2|Reported Event|PegIFN-2b+RBV+Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
415026|NCT00959699|E1|Reported Event|PegIFN-2b+RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
415027|NCT00959660|B5|Baseline|Total|Total of all reporting groups
415028|NCT00959660|B4|Baseline|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
415029|NCT00959660|B3|Baseline|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
415030|NCT00959660|B2|Baseline|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
415031|NCT00959660|B1|Baseline|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
415032|NCT00959660|P4|Participant Flow|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
415033|NCT00959660|P3|Participant Flow|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
415034|NCT00959660|P2|Participant Flow|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
415035|NCT00959660|P1|Participant Flow|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
415036|NCT00959660|O4|Outcome|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
415037|NCT00959660|O3|Outcome|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
415038|NCT00959660|O2|Outcome|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
415039|NCT00959660|O1|Outcome|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
415040|NCT00959660|O4|Outcome|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
415041|NCT00959660|O3|Outcome|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
415042|NCT00959660|O2|Outcome|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
415043|NCT00959660|O1|Outcome|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
415044|NCT00959660|O4|Outcome|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
415045|NCT00959660|O3|Outcome|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
415046|NCT00959660|O2|Outcome|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
415047|NCT00959660|O1|Outcome|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
415048|NCT00959660|O4|Outcome|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
415049|NCT00959660|O3|Outcome|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
415050|NCT00959660|O2|Outcome|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
415051|NCT00959660|O1|Outcome|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
415052|NCT00959660|E4|Reported Event|Diet and Exercise|"The diet and exercise group is a combination of the two groups previously described.~Exercise: walking, treadmill and bicycle exercise~Diet and exercise: Combination of the exercise and diet group as previously described."
415053|NCT00959660|E3|Reported Event|Attention Control|"Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.~Attention Control: control group- continue their previously randomized life style"
415054|NCT00959660|E2|Reported Event|Dietary Intervention|"A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.~Dietary Intervention: Subjects will be provided meals and instructions for individual food selections."
415055|NCT00959660|E1|Reported Event|Exercise Training|"Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.~Exercise: walking, treadmill and bicycle exercise"
415056|NCT00959647|B1|Baseline|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
415057|NCT00959647|P1|Participant Flow|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
415058|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
415059|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
415060|NCT00959647|E1|Reported Event|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
415061|NCT00959374|B1|Baseline|V-loc and Monocryl|All randomized subjects
415062|NCT00959374|P1|Participant Flow|V-loc and Monocryl|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
415063|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
415093|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415687|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415064|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
415065|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
415066|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
415067|NCT00959374|E4|Reported Event|Non-protocol Incision or Systemic Events|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature.
415068|NCT00959374|E3|Reported Event|Midline|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm.
415069|NCT00959374|E2|Reported Event|Control - Monocryl 3-0|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
415070|NCT00959374|E1|Reported Event|V-Loc 180 / 90|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
415071|NCT00959192|B5|Baseline|Total|Total of all reporting groups
415072|NCT00959192|B4|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415073|NCT00959192|B3|Baseline|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415074|NCT00959192|B2|Baseline|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415075|NCT00959192|B1|Baseline|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415076|NCT00959192|P4|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415077|NCT00959192|P3|Participant Flow|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415078|NCT00959192|P2|Participant Flow|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415079|NCT00959192|P1|Participant Flow|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415080|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415081|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415082|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415083|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
415084|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415085|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415086|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415087|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
415088|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415089|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415090|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415091|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
415092|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415130|NCT00959049|P3|Participant Flow|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415094|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415095|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415096|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415097|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415098|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415099|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
415100|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415101|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415102|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415103|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415104|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415105|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415106|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415107|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
415108|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415109|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415110|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415111|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
415112|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415113|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415114|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415115|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415116|NCT00959192|E4|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415117|NCT00959192|E3|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415118|NCT00959192|E2|Reported Event|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415119|NCT00959192|E1|Reported Event|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
415120|NCT00959049|B7|Baseline|Total|Total of all reporting groups
415121|NCT00959049|B6|Baseline|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415122|NCT00959049|B5|Baseline|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415123|NCT00959049|B4|Baseline|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415124|NCT00959049|B3|Baseline|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415125|NCT00959049|B2|Baseline|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415126|NCT00959049|B1|Baseline|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
415127|NCT00959049|P6|Participant Flow|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415128|NCT00959049|P5|Participant Flow|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415129|NCT00959049|P4|Participant Flow|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415131|NCT00959049|P2|Participant Flow|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415132|NCT00959049|P1|Participant Flow|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
415133|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
415134|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
415135|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
415136|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
415137|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
415138|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
415139|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 3 to < 9 years
415140|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years
415141|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
415142|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years
415143|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years
415144|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
415145|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415146|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415147|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415148|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415149|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415150|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
415151|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415152|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415153|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415154|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415155|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415156|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
415157|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415158|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415159|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415160|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415161|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415162|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
415163|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415164|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415165|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415166|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415167|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415168|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
415169|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
415170|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
415171|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
415172|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
415173|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
415174|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
415175|NCT00959049|E6|Reported Event|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415176|NCT00959049|E5|Reported Event|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415177|NCT00959049|E4|Reported Event|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
415178|NCT00959049|E3|Reported Event|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415179|NCT00959049|E2|Reported Event|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
415180|NCT00959049|E1|Reported Event|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
416627|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
415182|NCT00958919|P2|Participant Flow|Naloxone First, Then Normal Saline|Intravenous Naloxone (10mg/25 ml)in first intervention period and intravenous saline (25 ml) in second intervention period.
415183|NCT00958919|P1|Participant Flow|Normal Saline First, Then Naloxone|Intravenous saline (25 ml) in first intervention period and intravenous Naloxone (10mg/25 ml) in second intervention period.
415184|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Normal Saline (25 ml)
415185|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Normal Saline (25 ml)
415186|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Naloxone (10 mg/25 ml)
415187|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Naloxone (10 mg/25 ml)
415188|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)given prior to start of Resistive Load Breathing
415189|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml) given prior to start of Resistive Load Breathing
415190|NCT00958919|O2|Outcome|Naloxone|Intravension Naloxone (10mg/25ml)
415191|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
415192|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)
415193|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
415194|NCT00958919|E2|Reported Event|Naloxone|10mg/25ml Intravenous
415195|NCT00958919|E1|Reported Event|Normal Saline|25 ml Intravenous
415196|NCT00958893|B1|Baseline|25 mg Proellex|25 mg Proellex daily
415197|NCT00958893|P1|Participant Flow|25 mg Proellex|25 mg Proellex: one 25 mg capsules
415198|NCT00958893|O1|Outcome|25 mg Proellex|25 mg Proellex: one 25 mg capsules
415199|NCT00958893|E1|Reported Event|25 mg Proellex|25 mg Proellex: one 25 mg capsules
415200|NCT00958880|B3|Baseline|Total|Total of all reporting groups
415201|NCT00958880|B2|Baseline|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
415202|NCT00958880|B1|Baseline|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
415203|NCT00958880|P2|Participant Flow|Yohimbine Hydrochloride|Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
415204|NCT00958880|P1|Participant Flow|Sugar Pill|Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
415205|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
415206|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
415207|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
415208|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
415209|NCT00958880|E2|Reported Event|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
415210|NCT00958880|E1|Reported Event|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
415211|NCT00958841|B1|Baseline|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
415212|NCT00958841|P1|Participant Flow|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
415213|NCT00958841|O1|Outcome|Nelson's Syndrome|Nelson’s syndrome is associated with local tumor extension or invasion following a therapeutic bilateral adrenalectomy
415214|NCT00958841|O1|Outcome|All PiNETS (Prolactinoma)|One of the 10 types of PiNETs analyzed
415215|NCT00958841|O1|Outcome|All PNETS (Gastrinoma)|One of the 10 types of PNETs analyzed
415216|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
415217|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
415218|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
415219|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
415220|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
415221|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
415222|NCT00958841|O3|Outcome|Glucagonoma|One of the 10 types of PNETs analyzed.
415223|NCT00958841|O2|Outcome|VIpoma|One of the 10 types of PNETs analyzed.
415224|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
415225|NCT00958841|E4|Reported Event|Nelsons Syndrome|Nelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.
415226|NCT00958841|E3|Reported Event|Ectopic ACTH-secrting Tumors (EAS)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
415349|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415227|NCT00958841|E2|Reported Event|Pituitary NETs (PiNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
415228|NCT00958841|E1|Reported Event|Pancreatic NETs (PNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
415229|NCT00958828|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
415230|NCT00958828|P2|Participant Flow|Narafilcon A / Nelfilcon A|Narafilcon A contact lenses, then Nelfilcon A contact lenses
415231|NCT00958828|P1|Participant Flow|Nelfilcon A / Narafilcon A|Nelfilcon A contact lenses, then Narafilcon A contact lenses
415232|NCT00958828|O2|Outcome|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
415233|NCT00958828|O1|Outcome|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
415234|NCT00958828|E2|Reported Event|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
415235|NCT00958828|E1|Reported Event|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
415236|NCT00958789|B1|Baseline|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
415237|NCT00958789|P1|Participant Flow|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
415238|NCT00958789|O1|Outcome|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
415239|NCT00958789|E1|Reported Event|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
415240|NCT00958776|B3|Baseline|Total|Total of all reporting groups
415241|NCT00958776|B2|Baseline|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415242|NCT00958776|B1|Baseline|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415243|NCT00958776|P2|Participant Flow|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415244|NCT00958776|P1|Participant Flow|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415245|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415246|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415247|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415248|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415249|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415250|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415251|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415252|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415253|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415254|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415255|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415256|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415688|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415257|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415258|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415259|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415260|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415261|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415262|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415263|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415264|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415265|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415266|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415267|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415268|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415269|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415270|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415271|NCT00958776|E2|Reported Event|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
415272|NCT00958776|E1|Reported Event|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
415273|NCT00958724|B1|Baseline|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415274|NCT00958724|P1|Participant Flow|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415275|NCT00958724|O1|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415276|NCT00958724|O1|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415277|NCT00958724|O1|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415278|NCT00958724|O1|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415279|NCT00958724|O1|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415280|NCT00958724|O1|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415281|NCT00958724|O1|Outcome|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415282|NCT00958724|E1|Reported Event|Nera 240 + Vino 25|Neratinib 240 mg + Vinorelbine 25 mg/m2
415283|NCT00958581|B4|Baseline|Total|Total of all reporting groups
415284|NCT00958581|B3|Baseline|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
415285|NCT00958581|B2|Baseline|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
415286|NCT00958581|B1|Baseline|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
415287|NCT00958581|P3|Participant Flow|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
415288|NCT00958581|P2|Participant Flow|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
415289|NCT00958581|P1|Participant Flow|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
415290|NCT00958581|O3|Outcome|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid: For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
415291|NCT00958581|O2|Outcome|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid: For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
415292|NCT00958581|O1|Outcome|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline: Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose."
415293|NCT00958581|O3|Outcome|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid: For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
415294|NCT00958581|O2|Outcome|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid: For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
415295|NCT00958581|O1|Outcome|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline: Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose."
415296|NCT00958581|O3|Outcome|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
415297|NCT00958581|O2|Outcome|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
415298|NCT00958581|O1|Outcome|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
415299|NCT00958581|E3|Reported Event|Tranexamic Acid|"Patients receive TXA before and during the surgical case.~Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr."
415300|NCT00958581|E2|Reported Event|Normal Saline|"Patients infused with normal saline before and during the surgical procedure as a placebo.~Normal Saline :"
415301|NCT00958581|E1|Reported Event|Epsilon Aminocaproic Acid|"Patients will receive EACA before and during the surgical case.~Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr."
415302|NCT00958568|B1|Baseline|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
415303|NCT00958568|P4|Participant Flow|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415304|NCT00958568|P3|Participant Flow|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
415305|NCT00958568|P2|Participant Flow|OFC (SPIII)|6 mg Olanzapine and 25 mg Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
415306|NCT00958568|P1|Participant Flow|OFC (SPII )|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
415307|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415308|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
415309|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415310|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415311|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415312|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415313|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415314|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415315|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415316|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415317|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415380|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415318|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415319|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415320|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415321|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415322|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415323|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415324|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415325|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415326|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415327|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415328|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415329|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415330|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415331|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415332|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415333|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415334|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415335|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415336|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415337|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415338|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415339|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415340|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415341|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415342|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415343|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415344|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415345|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415346|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415347|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415348|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415350|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415351|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415352|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415353|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415354|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415355|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415356|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415357|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415358|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415359|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415360|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415361|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415362|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415363|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
415364|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
415365|NCT00958568|O1|Outcome|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
415366|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415367|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415368|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415369|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415370|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415371|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415372|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415373|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415374|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415375|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415376|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415377|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415378|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415379|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
419233|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
415381|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415382|NCT00958568|E4|Reported Event|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
415383|NCT00958568|E3|Reported Event|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
415384|NCT00958568|E2|Reported Event|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
415385|NCT00958568|E1|Reported Event|OFC (SPII)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
415386|NCT00958477|B5|Baseline|Total|Total of all reporting groups
415387|NCT00958477|B4|Baseline|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415388|NCT00958477|B3|Baseline|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415389|NCT00958477|B2|Baseline|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415390|NCT00958477|B1|Baseline|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415391|NCT00958477|P4|Participant Flow|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415392|NCT00958477|P3|Participant Flow|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415393|NCT00958477|P2|Participant Flow|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415394|NCT00958477|P1|Participant Flow|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415395|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415396|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415397|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415398|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415399|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415400|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415401|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415402|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415403|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415404|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415405|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415406|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415407|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415408|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415409|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415410|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415411|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415412|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415413|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415414|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415415|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415416|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415417|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415620|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
415621|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
415418|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415419|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415420|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415421|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415422|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415423|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415424|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415425|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415426|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415427|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415428|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415429|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415430|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415431|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415432|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415433|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415434|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415622|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
415623|NCT00958282|E2|Reported Event|Placebo|"Placebo Comparator once per day~placebo"
415435|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415436|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415437|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415438|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415439|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415440|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415441|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415442|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415443|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415444|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415445|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415446|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415447|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415448|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415449|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415450|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415451|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415624|NCT00958282|E1|Reported Event|Lisdexamfetamine/Behavior Therapy|"lisdexamfetamine 70mg/day plus Behavior Therapy~lisdexamfetamine/Behavior Therapy"
415689|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415452|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415453|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415454|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415455|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415456|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415457|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415458|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415459|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415460|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415461|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415462|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415463|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415464|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415465|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415466|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415467|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415468|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415673|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
415674|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
415675|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
415469|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415470|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415471|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415472|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415473|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415474|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415475|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415476|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415477|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415478|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415479|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415480|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415481|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415482|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who will be clinically benefitted at the end of Week 6 will continue at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415483|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415484|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415485|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415676|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
415677|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
419234|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
415486|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415487|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415488|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415489|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415490|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415491|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415492|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415493|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415494|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415495|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415496|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415497|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415498|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415499|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415500|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415501|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415502|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415678|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415679|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415503|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415504|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415505|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415506|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415507|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415508|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415509|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415510|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415511|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415512|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415513|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415514|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415515|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415516|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415517|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415518|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415519|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415680|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415681|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415520|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415521|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415522|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415523|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415524|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415525|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415526|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415527|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415528|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415529|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415530|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415531|NCT00958477|O4|Outcome|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415532|NCT00958477|O3|Outcome|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415533|NCT00958477|O2|Outcome|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415534|NCT00958477|O1|Outcome|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415535|NCT00958477|E4|Reported Event|EMD 525797 1500 mg|Subjects were administered with 1500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415536|NCT00958477|E3|Reported Event|EMD 525797 1000 mg|Subjects were administered with 1000 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415682|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415683|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415537|NCT00958477|E2|Reported Event|EMD 525797 500 mg|Subjects were administered with 500 mg of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415538|NCT00958477|E1|Reported Event|EMD 525797 250 mg|Subjects were administered with 250 milligram (mg) of EMD 525797 intravenously over 1 hour every 2 weeks for 6 weeks. Subjects who were clinically benefitted at the end of Week 6 continued at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or if the subject was no longer benefitted from the treatment as per Investigator’s discretion.
415539|NCT00958438|B4|Baseline|Total|Total of all reporting groups
415540|NCT00958438|B3|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415541|NCT00958438|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415542|NCT00958438|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415543|NCT00958438|P3|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415544|NCT00958438|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415545|NCT00958438|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415546|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415547|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415548|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415549|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415550|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415551|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415552|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415553|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415554|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415555|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415556|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415557|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415558|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415559|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415560|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415561|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415562|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415563|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
415564|NCT00958438|E3|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
415565|NCT00958438|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
415566|NCT00958438|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
415567|NCT00958360|B3|Baseline|Total|Total of all reporting groups
415684|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415867|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
415568|NCT00958360|B2|Baseline|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415569|NCT00958360|B1|Baseline|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415570|NCT00958360|P2|Participant Flow|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415571|NCT00958360|P1|Participant Flow|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415572|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415573|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415574|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415575|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415576|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415577|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415578|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415579|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415580|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415581|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415582|NCT00958360|E2|Reported Event|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
415685|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415686|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
419235|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
415583|NCT00958360|E1|Reported Event|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
415584|NCT00958347|B1|Baseline|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
415585|NCT00958347|P1|Participant Flow|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem.
415586|NCT00958347|O1|Outcome|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
415587|NCT00958347|E1|Reported Event|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
415588|NCT00958334|B4|Baseline|Total|Total of all reporting groups
415589|NCT00958334|B3|Baseline|Placebo Comparator|Placebo capsule once daily
415590|NCT00958334|B2|Baseline|Proellex 12.5 mg|Proellex® 12.5 mg once daily
415591|NCT00958334|B1|Baseline|Proellex 25 mg|Proellex® 12.5 mg twice daily
415592|NCT00958334|P3|Participant Flow|Placebo Comparator|Placebo capsules orally QD
415593|NCT00958334|P2|Participant Flow|Proellex 12.5 mg|Proellex® 12.5 mg capsules orally QD
415594|NCT00958334|P1|Participant Flow|Proellex 25 mg|Proellex® 12.5 mg orally capsules BID
415595|NCT00958334|O3|Outcome|Placebo Comparator|Placebo capsule once daily
415596|NCT00958334|O2|Outcome|Proellex 12.5 mg|Proellex® 12.5 mg once daily
415597|NCT00958334|O1|Outcome|Proellex 25 mg|Proellex® 12.5 mg twice daily
415598|NCT00958334|E3|Reported Event|Placebo Comparator|Placebo capsule once daily
415599|NCT00958334|E2|Reported Event|Proellex 12.5 mg|Proellex® 12.5 mg once daily
415600|NCT00958334|E1|Reported Event|Proellex 25 mg|Proellex® 12.5 mg twice daily
415601|NCT00958308|B4|Baseline|Total|Total of all reporting groups
415602|NCT00958308|B3|Baseline|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415603|NCT00958308|B2|Baseline|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415604|NCT00958308|B1|Baseline|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415605|NCT00958308|P3|Participant Flow|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415606|NCT00958308|P2|Participant Flow|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415607|NCT00958308|P1|Participant Flow|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415608|NCT00958308|O3|Outcome|BIO-K+ CL-1285|Two capsules of probiotic (each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415609|NCT00958308|O2|Outcome|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415610|NCT00958308|O1|Outcome|Placebo|Two capsules of placebo (devoid of microorganisms)per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415611|NCT00958308|E3|Reported Event|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415612|NCT00958308|E2|Reported Event|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415613|NCT00958308|E1|Reported Event|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
415614|NCT00958282|B3|Baseline|Total|Total of all reporting groups
415615|NCT00958282|B2|Baseline|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
415616|NCT00958282|B1|Baseline|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
415617|NCT00958282|P2|Participant Flow|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
415618|NCT00958282|P1|Participant Flow|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
415619|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
419236|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
415625|NCT00958256|B1|Baseline|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
415626|NCT00958256|P1|Participant Flow|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, Granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
415627|NCT00958256|O1|Outcome|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
415628|NCT00958256|E1|Reported Event|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
415629|NCT00958243|B7|Baseline|Total|Total of all reporting groups
415630|NCT00958243|B6|Baseline|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415631|NCT00958243|B5|Baseline|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415632|NCT00958243|B4|Baseline|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415633|NCT00958243|B3|Baseline|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415634|NCT00958243|B2|Baseline|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415635|NCT00958243|B1|Baseline|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415636|NCT00958243|P6|Participant Flow|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415637|NCT00958243|P5|Participant Flow|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415638|NCT00958243|P4|Participant Flow|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415639|NCT00958243|P3|Participant Flow|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415640|NCT00958243|P2|Participant Flow|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415641|NCT00958243|P1|Participant Flow|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415642|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415643|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415644|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415645|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415646|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415647|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415648|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415649|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415650|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415651|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415652|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415653|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415654|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
415655|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
415656|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
415657|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415658|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415659|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415660|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415661|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415662|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415663|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415664|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415665|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415666|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415667|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415668|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415669|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
415670|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
415671|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
415672|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
415690|NCT00958243|E6|Reported Event|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415691|NCT00958243|E5|Reported Event|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
415692|NCT00958243|E4|Reported Event|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
415693|NCT00958243|E3|Reported Event|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415694|NCT00958243|E2|Reported Event|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
415695|NCT00958243|E1|Reported Event|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
415696|NCT00958217|B3|Baseline|Total|Total of all reporting groups
415697|NCT00958217|B2|Baseline|Arm 2: ICBT|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
415698|NCT00958217|B1|Baseline|Arm 1: CPT-M|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
415699|NCT00958217|P2|Participant Flow|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
415700|NCT00958217|P1|Participant Flow|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
415701|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
415702|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
415703|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
415704|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
415705|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
415706|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
415707|NCT00958217|E3|Reported Event|ICBT Prior to Randomization|"All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills.~This portion will report on only those participants who were not randomized to individual CPT-M or ICBT."
415708|NCT00958217|E2|Reported Event|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
415709|NCT00958217|E1|Reported Event|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
415710|NCT00958191|B1|Baseline|Trident® X3 Polyethylene Insert|All subjects who recieved the Trident X3 insert.
415711|NCT00958191|P1|Participant Flow|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
415712|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415713|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415714|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415715|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415716|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415717|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415718|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415719|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415720|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415721|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
415722|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received theTrident® X3 Polyethylene Insert
415723|NCT00958191|E2|Reported Event|Non-operative Adverse Events|Trident X3 Polyethylene Insert. Non-operative site events are reported by participant.
415724|NCT00958191|E1|Reported Event|Operative Adverse Events|Trident X3 Polyethylene Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.
415725|NCT00958165|B1|Baseline|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
415726|NCT00958165|P1|Participant Flow|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
415727|NCT00958165|O1|Outcome|EAS-AC|Pulmonary vein isolation treatment with EAS-AC for PAF
415728|NCT00958165|E1|Reported Event|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
415729|NCT00958126|B9|Baseline|Total|Total of all reporting groups
415730|NCT00958126|B8|Baseline|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415731|NCT00958126|B7|Baseline|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415732|NCT00958126|B6|Baseline|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415733|NCT00958126|B5|Baseline|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415734|NCT00958126|B4|Baseline|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415735|NCT00958126|B3|Baseline|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415736|NCT00958126|B2|Baseline|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415737|NCT00958126|B1|Baseline|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415738|NCT00958126|P8|Participant Flow|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415739|NCT00958126|P7|Participant Flow|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415740|NCT00958126|P6|Participant Flow|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415741|NCT00958126|P5|Participant Flow|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415742|NCT00958126|P4|Participant Flow|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415743|NCT00958126|P3|Participant Flow|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415744|NCT00958126|P2|Participant Flow|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415745|NCT00958126|P1|Participant Flow|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415746|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Age Cohorts Combined|30 mcg of hemagglutinin antigen per dose
415747|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Age Cohorts Combined|15 mcg of hemagglutinin antigen per dose
415748|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Age Cohorts Combined|7.5 mcg of hemagglutinin antigen per dose
415749|NCT00958126|O1|Outcome|Placebo, Age Cohorts Combined|Vaccine diluent
415750|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415751|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415752|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415753|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415754|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415755|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415756|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415757|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415758|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415759|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415760|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415761|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415762|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415763|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415868|NCT00957996|E2|Reported Event|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
415764|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415765|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415766|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415767|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415768|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415769|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415770|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415771|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415772|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415773|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415774|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415775|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415776|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415777|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415778|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415779|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415780|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415781|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415782|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415783|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415784|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415785|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415786|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415787|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415788|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415789|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415790|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415791|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415792|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415793|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415794|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415795|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415796|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415797|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415798|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415799|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415800|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415801|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415802|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415803|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415804|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415805|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415806|NCT00958126|E8|Reported Event|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415807|NCT00958126|E7|Reported Event|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415808|NCT00958126|E6|Reported Event|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
415809|NCT00958126|E5|Reported Event|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
415810|NCT00958126|E4|Reported Event|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415811|NCT00958126|E3|Reported Event|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415812|NCT00958126|E2|Reported Event|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
415813|NCT00958126|E1|Reported Event|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
415814|NCT00958074|B3|Baseline|Total|Total of all reporting groups
415815|NCT00958074|B2|Baseline|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415869|NCT00957996|E1|Reported Event|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
415816|NCT00958074|B1|Baseline|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415817|NCT00958074|P2|Participant Flow|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415818|NCT00958074|P1|Participant Flow|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415819|NCT00958074|O2|Outcome|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415820|NCT00958074|O1|Outcome|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415821|NCT00958074|E2|Reported Event|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415822|NCT00958074|E1|Reported Event|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
415823|NCT00958035|B3|Baseline|Total|Total of all reporting groups
415824|NCT00958035|B2|Baseline|Placebo|vehicle sterile solution
415825|NCT00958035|B1|Baseline|LATISSE®|bimatoprost ophthalmic 0.03% solution
415826|NCT00958035|P2|Participant Flow|Placebo|vehicle sterile solution
415827|NCT00958035|P1|Participant Flow|LATISSE®|bimatoprost ophthalmic 0.03% solution
415828|NCT00958035|O2|Outcome|Placebo|vehicle sterile solution
415829|NCT00958035|O1|Outcome|LATISSE®|bimatoprost ophthalmic 0.03% solution
415830|NCT00958035|E2|Reported Event|Placebo|vehicle sterile solution
415831|NCT00958035|E1|Reported Event|LATISSE®|bimatoprost ophthalmic 0.03% solution
415832|NCT00958009|B1|Baseline|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
415833|NCT00958009|P1|Participant Flow|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
415834|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
415835|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
415836|NCT00958009|E1|Reported Event|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
415837|NCT00957996|B3|Baseline|Total|Total of all reporting groups
415838|NCT00957996|B2|Baseline|Peramivir 600mg|"600 mg once daily~Peramivir: 600 mg once daily"
415839|NCT00957996|B1|Baseline|Peramivir 300mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
415840|NCT00957996|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg once daily
415841|NCT00957996|P1|Participant Flow|Peramivir 300 mg|Peramivir 300 mg twice daily
415842|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415843|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415844|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
415845|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
415846|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415847|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415848|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415849|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415850|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415851|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415852|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415853|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415854|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415855|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415856|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415857|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415858|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415859|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415860|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
415861|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
415862|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415863|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415864|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
415865|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
415866|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
415871|NCT00957944|B2|Baseline|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
415872|NCT00957944|B1|Baseline|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
415873|NCT00957944|P2|Participant Flow|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
415874|NCT00957944|P1|Participant Flow|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
415875|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415876|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415877|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415878|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415879|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415880|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415881|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415882|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415883|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415884|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415885|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415886|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415887|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415888|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415889|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415890|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415891|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415892|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415893|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415894|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415895|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415896|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415897|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415898|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
416628|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
415899|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415900|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415901|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415902|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415903|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415904|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415905|NCT00957944|E2|Reported Event|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
415906|NCT00957944|E1|Reported Event|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
415907|NCT00957905|B3|Baseline|Total|Total of all reporting groups
415908|NCT00957905|B2|Baseline|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
415909|NCT00957905|B1|Baseline|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
415910|NCT00957905|P2|Participant Flow|Part B|"6 wks: Flavopiridol:70 mg/m2/day IV 1 hr Days 1, 15 & 29. Oxaliplatin:85 mg/m2/day IV 2 hrs Days 1, 15 & 29. Leucovorin:400 mg/m2/day IV 2 hrs Days 1, 15 & 29.~5-FU: 400 mg/m2 IV 15 min, and 1800 mg/m2 IV 48 hrs Days 1-2, 15-16 & 29-30."
415911|NCT00957905|P1|Participant Flow|Part A|6 weeks: Flavopiridol: 70 mg/m2/day IV over 1 hr on days 1, 15 and 29. Oxaliplatin: 85 mg/m2/day IV over 2 hrs on days 1, 15 and 29.
415912|NCT00957905|O2|Outcome|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
415913|NCT00957905|O1|Outcome|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
415914|NCT00957905|E2|Reported Event|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
415915|NCT00957905|E1|Reported Event|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
415916|NCT00957801|B5|Baseline|Total|Total of all reporting groups
415917|NCT00957801|B4|Baseline|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415918|NCT00957801|B3|Baseline|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415919|NCT00957801|B2|Baseline|Testosterone Gel|"Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415920|NCT00957801|B1|Baseline|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415921|NCT00957801|P4|Participant Flow|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415922|NCT00957801|P3|Participant Flow|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415923|NCT00957801|P2|Participant Flow|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415924|NCT00957801|P1|Participant Flow|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415968|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
419237|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
415925|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415926|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415927|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415928|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415929|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415930|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415931|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415932|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415933|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415934|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415935|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415936|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415937|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415938|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415939|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415940|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415941|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415942|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415943|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415944|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415945|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416012|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415946|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415947|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415948|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415949|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415950|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415951|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415952|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415953|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415954|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415955|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415956|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415957|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415958|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415959|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415960|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415961|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415962|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415963|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415964|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415965|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415966|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415967|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416443|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
415969|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415970|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415971|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415972|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415973|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415974|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415975|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415976|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415977|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415978|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415979|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415980|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415981|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415982|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415983|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415984|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415985|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415986|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415987|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415988|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415989|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416056|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415990|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415991|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415992|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415993|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415994|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415995|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
415996|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
415997|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415998|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
415999|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416000|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416001|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416002|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416003|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416004|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416005|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416006|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416007|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416008|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416009|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416010|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416011|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416115|NCT00957684|E3|Reported Event|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
416013|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416014|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416015|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416016|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416017|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416018|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416019|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416020|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416021|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416022|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416023|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416024|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416025|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416026|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416027|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416028|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416029|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416030|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416031|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416032|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416033|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416116|NCT00957684|E2|Reported Event|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
419238|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
416034|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416035|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416036|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416037|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416038|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416039|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416040|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416041|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416042|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416043|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416044|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416045|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416046|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416047|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416048|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416049|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416050|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416051|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416052|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416053|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416054|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416055|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416117|NCT00957684|E1|Reported Event|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
416057|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416058|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416059|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416060|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416061|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416062|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416063|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416064|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416065|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416066|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416067|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416068|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416069|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416070|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416071|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416072|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416073|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416074|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416075|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416076|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416077|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416387|NCT00957372|P2|Participant Flow|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
416078|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416079|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416080|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416081|NCT00957801|O4|Outcome|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416082|NCT00957801|O3|Outcome|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416083|NCT00957801|O2|Outcome|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416084|NCT00957801|O1|Outcome|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416085|NCT00957801|E4|Reported Event|Medrol 6 Day Dose Pack|"Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416086|NCT00957801|E3|Reported Event|Testosterone Injection and Medrol 6 Day Dose Pack|"Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.~Testosterone injection: 100 mg single IM injection~Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7"
416087|NCT00957801|E2|Reported Event|Testosterone Gel|"Testosterone topical gel 10 mg administered daily for seven days~Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days"
416088|NCT00957801|E1|Reported Event|Testosterone Injection|"Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection~Testosterone injection: 100 mg single IM injection"
416089|NCT00957723|B1|Baseline|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
416090|NCT00957723|P1|Participant Flow|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed.
416091|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416092|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416093|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416094|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416095|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416096|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416097|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416098|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
416099|NCT00957723|E1|Reported Event|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
416100|NCT00957684|B5|Baseline|Total|Total of all reporting groups
416101|NCT00957684|B4|Baseline|Placebo|Placebo tablets; once daily administration by oral route
416102|NCT00957684|B3|Baseline|ESL 400 mg|400-mg; once daily administration by oral route
416103|NCT00957684|B2|Baseline|ESL 800 mg|800-mg; once daily administration by oral route
416104|NCT00957684|B1|Baseline|ESL 1200 mg|400-mg + 800-mg; once daily administration by oral route
416105|NCT00957684|P5|Participant Flow|ESL - Part II|During Part II of the study all patients received ESL, including those who had been treated with placebo during Part I. The duration of treatment during Part II was one year for all patients completing the study.
416106|NCT00957684|P4|Participant Flow|Placebo|placebo : once daily placebo comparator
416107|NCT00957684|P3|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
416108|NCT00957684|P2|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
416109|NCT00957684|P1|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
416110|NCT00957684|O4|Outcome|ESL 1200 mg|ESL was supplied in 400-mg and 800-mg tablets; once daily administration by oral route.
416111|NCT00957684|O3|Outcome|ESL 800 mg|ESL was supplied in 800-mg tablets; once daily administration by oral route.
416112|NCT00957684|O2|Outcome|ESL 400 mg|ESL was supplied in 400-mg tablets; once daily administration by oral route.
416113|NCT00957684|O1|Outcome|Placebo|Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied; once daily administration by oral route.
416114|NCT00957684|E4|Reported Event|Placebo|placebo : once daily placebo comparator
416118|NCT00957671|B1|Baseline|Human Growth Hormone|"Recombinant human growth hormone (rhGH) self administered daily for one year~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)"
416119|NCT00957671|P1|Participant Flow|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416120|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416121|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416122|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416123|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416124|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416125|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416126|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416127|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416128|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416129|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416130|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416131|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416132|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416133|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416134|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416135|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416136|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416137|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416138|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416139|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416140|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416141|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416142|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416143|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416144|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416145|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416146|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416147|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416148|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416149|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416150|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416151|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416152|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416153|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416154|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416155|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416156|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416157|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416158|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416159|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416160|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416161|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416162|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416163|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416164|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416165|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year~Recombinant human growth hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)"
416166|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416167|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416168|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416169|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416170|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416171|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416172|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416173|NCT00957671|O1|Outcome|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416174|NCT00957671|E1|Reported Event|Human Growth Hormone|"recombinant human growth hormone (rhGH) self administered daily for one year.~Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)."
416175|NCT00957658|B1|Baseline|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
416176|NCT00957658|P1|Participant Flow|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.
416177|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416178|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416179|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416180|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416181|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416182|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem.
416183|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416184|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416185|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
416186|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
416187|NCT00957658|E1|Reported Event|Accolade TMZF Hip Stem|Participants who received the Accolade TMZF Hip Stem
416188|NCT00957593|B3|Baseline|Total|Total of all reporting groups
416189|NCT00957593|B2|Baseline|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
416190|NCT00957593|B1|Baseline|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
416191|NCT00957593|P2|Participant Flow|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
416192|NCT00957593|P1|Participant Flow|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
416193|NCT00957593|O2|Outcome|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
416194|NCT00957593|O1|Outcome|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
416195|NCT00957593|E2|Reported Event|Oxytocin Discontinuation|Oxytocin discontinuation in the active phase of labor
416196|NCT00957593|E1|Reported Event|Oxytocin Arm|no adverse effects noted amongst the 252 patients enrolled in the study 127 in ROUTINE 125 in DISCONTINUATION ARM
416197|NCT00957580|B4|Baseline|Total|Total of all reporting groups
416198|NCT00957580|B3|Baseline|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416199|NCT00957580|B2|Baseline|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416200|NCT00957580|B1|Baseline|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416201|NCT00957580|P3|Participant Flow|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416202|NCT00957580|P2|Participant Flow|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416203|NCT00957580|P1|Participant Flow|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416204|NCT00957580|O2|Outcome|Regimen 2 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416205|NCT00957580|O1|Outcome|Regimen 1 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416206|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416207|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416208|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416209|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416210|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416211|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416212|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416213|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416214|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416215|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416216|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416217|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416218|NCT00957580|O1|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416219|NCT00957580|O8|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416220|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416221|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416222|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416223|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416224|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416225|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416226|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416227|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416228|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416229|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416230|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416231|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416232|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416233|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416234|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416235|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416236|NCT00957580|O1|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416237|NCT00957580|O8|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416238|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416239|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416240|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416241|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416242|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416388|NCT00957372|P1|Participant Flow|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
416444|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416243|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416244|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416245|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416246|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416247|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416248|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416249|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416250|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416251|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416252|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416253|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416254|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416255|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416256|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416257|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416258|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416259|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416260|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416261|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416389|NCT00957372|O7|Outcome|TEAE Leading to Death|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416505|NCT00957242|O2|Outcome|Warfarin|warfarin sodium titrated to an INR of 2.0-3.0
416262|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416263|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416264|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416265|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416266|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416267|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416268|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416269|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416270|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416271|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416272|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416273|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416274|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416275|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416276|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416277|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416278|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416279|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416280|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416281|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416282|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416283|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416284|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416285|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416286|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416287|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416288|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416289|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416290|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416291|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416292|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416293|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416294|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416295|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416296|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416297|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416298|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416299|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416300|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416390|NCT00957372|O6|Outcome|Treatment Emergent Serious Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416301|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416302|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416303|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416304|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416305|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416306|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416307|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416308|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416309|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416310|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416311|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416312|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416313|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416314|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416315|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416316|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416317|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416318|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416319|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416320|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416321|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416322|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416323|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416324|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416325|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416326|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416327|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416328|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416329|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416330|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416331|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416332|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416333|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416334|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416335|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416336|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416337|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416338|NCT00957580|O2|Outcome|Regimen 2 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416339|NCT00957580|O1|Outcome|Regimen 1 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416340|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416341|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416342|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416343|NCT00957580|E3|Reported Event|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416344|NCT00957580|E2|Reported Event|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416345|NCT00957580|E1|Reported Event|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
416346|NCT00957528|B4|Baseline|Total|Total of all reporting groups
416347|NCT00957528|B3|Baseline|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416348|NCT00957528|B2|Baseline|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416349|NCT00957528|B1|Baseline|Placebo|Weekly placebo treatment for a duration of 5 months.
416350|NCT00957528|P3|Participant Flow|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416351|NCT00957528|P2|Participant Flow|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416352|NCT00957528|P1|Participant Flow|Placebo|Weekly placebo treatment for a duration of 5 months.
416353|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416354|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416355|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
416356|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416357|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416358|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
416359|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416360|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416361|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
416362|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416363|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416364|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
416365|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416366|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416367|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
416368|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416369|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416370|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
416371|NCT00957528|E3|Reported Event|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
416372|NCT00957528|E2|Reported Event|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
416373|NCT00957528|E1|Reported Event|Placebo|Weekly placebo treatment for a duration of 5 months.
416374|NCT00957424|B1|Baseline|Overall|Single-armed study
416375|NCT00957424|P1|Participant Flow|Noncombusted Nicotine Product With Informational Intervention|Single-armed study
416376|NCT00957424|O1|Outcome|Overall|Single-armed study
416377|NCT00957424|O1|Outcome|Overall|Single-armed study
416378|NCT00957424|O1|Outcome|Overall|Single-armed study
416379|NCT00957424|O1|Outcome|Overall|Single-armed study
416380|NCT00957424|E1|Reported Event|Overall|Single-armed study
416381|NCT00957372|B4|Baseline|Total|Total of all reporting groups
416382|NCT00957372|B3|Baseline|Placebo|"placebo~placebo : once daily placebo comparator"
416383|NCT00957372|B2|Baseline|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
416384|NCT00957372|B1|Baseline|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
416385|NCT00957372|P4|Participant Flow|Open-label Extension (Part II)|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416386|NCT00957372|P3|Participant Flow|Placebo|"placebo~placebo : once daily placebo comparator"
416506|NCT00957242|O1|Outcome|Placebo|matched placebo
416391|NCT00957372|O5|Outcome|TEAE Leading to Discontinuation From the Study|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416392|NCT00957372|O4|Outcome|Treatment-related Treatment-emergent Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416393|NCT00957372|O3|Outcome|TEAE With Onset After the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416394|NCT00957372|O2|Outcome|TEAE With Onset Within the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416395|NCT00957372|O1|Outcome|TEAE|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
416396|NCT00957372|O3|Outcome|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
416397|NCT00957372|O2|Outcome|ESL 800 mg|400 mg active substance tablets were supplied
416398|NCT00957372|O1|Outcome|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied.
416399|NCT00957372|E4|Reported Event|Open-label Extension (Part II)|ESL dose taken; Starting at 800 mg once daily, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg once daily or up to a maximum of 1200 mg once daily.
416400|NCT00957372|E3|Reported Event|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
416401|NCT00957372|E2|Reported Event|ESL 800 mg|400 mg active substance tablets were supplied
416402|NCT00957372|E1|Reported Event|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied
416403|NCT00957333|B1|Baseline|Case|"ketamine + Cystitis~ketamine"
416404|NCT00957333|P1|Participant Flow|Case|"ketamine + Cystitis~ketamine"
416405|NCT00957333|O1|Outcome|Case|"ketamine + Cystitis~ketamine"
416406|NCT00957333|E1|Reported Event|Case|"ketamine + Cystitis~ketamine"
416407|NCT00957268|B6|Baseline|Total|Total of all reporting groups
416408|NCT00957268|B5|Baseline|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416409|NCT00957268|B4|Baseline|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416410|NCT00957268|B3|Baseline|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416411|NCT00957268|B2|Baseline|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416412|NCT00957268|B1|Baseline|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416413|NCT00957268|P5|Participant Flow|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416414|NCT00957268|P4|Participant Flow|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416415|NCT00957268|P3|Participant Flow|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416416|NCT00957268|P2|Participant Flow|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416417|NCT00957268|P1|Participant Flow|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416418|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416419|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416420|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416421|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416422|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416423|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416424|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416425|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416426|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416427|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416428|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416429|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416430|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416431|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416432|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416433|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416434|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416435|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416436|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416437|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416438|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416439|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416440|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416441|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416442|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416445|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416446|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416447|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416448|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416449|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416450|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416451|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416452|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416453|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416454|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416455|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416456|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416457|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416458|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416459|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416460|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416461|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416462|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416463|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416464|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416465|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416466|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416467|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416468|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416469|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416470|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416471|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416472|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416473|NCT00957268|E5|Reported Event|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416474|NCT00957268|E4|Reported Event|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416475|NCT00957268|E3|Reported Event|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416476|NCT00957268|E2|Reported Event|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
416477|NCT00957268|E1|Reported Event|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
416478|NCT00957242|B3|Baseline|Total|Total of all reporting groups
416479|NCT00957242|B2|Baseline|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
416480|NCT00957242|B1|Baseline|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
416481|NCT00957242|P2|Participant Flow|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
416482|NCT00957242|P1|Participant Flow|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
416483|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416484|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416485|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416486|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416487|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416488|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416489|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416490|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416491|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416492|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416493|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416494|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416495|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416496|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416497|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416498|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416499|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416500|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416501|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416502|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416503|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
416504|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
416507|NCT00957242|E2|Reported Event|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
416508|NCT00957242|E1|Reported Event|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
416509|NCT00957047|B5|Baseline|Total|Total of all reporting groups
416510|NCT00957047|B4|Baseline|Placebo|placebo : once daily placebo comparator
416511|NCT00957047|B3|Baseline|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
416512|NCT00957047|B2|Baseline|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
416513|NCT00957047|B1|Baseline|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
416514|NCT00957047|P5|Participant Flow|ESL - Part II|All patients in Part II received ESL on an open-label basis, starting at 800 mg once daily.
416515|NCT00957047|P4|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
416516|NCT00957047|P3|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
416517|NCT00957047|P2|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
416518|NCT00957047|P1|Participant Flow|Placebo|placebo : once daily placebo comparator
416519|NCT00957047|O7|Outcome|TEAE Leading to Death|
416520|NCT00957047|O6|Outcome|Serious TEAE|
416521|NCT00957047|O5|Outcome|TEAE Leading to Discontinuation|
416522|NCT00957047|O4|Outcome|Treatment-related TEAE|
416523|NCT00957047|O3|Outcome|TEAE With Onset After 1st 4 Weeks|
416524|NCT00957047|O2|Outcome|TEAE With Onset Within the 1st 4 Weeks|
416525|NCT00957047|O1|Outcome|TEAE|
416526|NCT00957047|O4|Outcome|Placebo|placebo : once daily placebo comparator
416527|NCT00957047|O3|Outcome|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
416528|NCT00957047|O2|Outcome|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
416529|NCT00957047|O1|Outcome|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
416530|NCT00957047|E5|Reported Event|ESL PART II|All patients in Part II received ESL
416531|NCT00957047|E4|Reported Event|ESL 1200 mg|Tablets; oral route
416532|NCT00957047|E3|Reported Event|ESL 800 mg|Tablets; oral route
416533|NCT00957047|E2|Reported Event|ESL 400 mg|Tablets; oral route
416534|NCT00957047|E1|Reported Event|Placebo|Tablets; oral route
416535|NCT00957034|B4|Baseline|Total|Total of all reporting groups
416536|NCT00957034|B3|Baseline|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416537|NCT00957034|B2|Baseline|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416538|NCT00957034|B1|Baseline|Placebo|placebo patch
416539|NCT00957034|P3|Participant Flow|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416540|NCT00957034|P2|Participant Flow|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416541|NCT00957034|P1|Participant Flow|Placebo|placebo patch
416542|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416543|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416544|NCT00957034|O1|Outcome|Placebo|placebo patch
416545|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416546|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416547|NCT00957034|O1|Outcome|Placebo|placebo patch
416548|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416549|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416550|NCT00957034|O1|Outcome|Placebo|placebo patch
416551|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416552|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416553|NCT00957034|O1|Outcome|Placebo|placebo patch
416554|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416555|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416556|NCT00957034|O1|Outcome|Placebo|placebo patch
416557|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416558|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416559|NCT00957034|O1|Outcome|Placebo|placebo patch
416560|NCT00957034|E3|Reported Event|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
416561|NCT00957034|E2|Reported Event|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
416562|NCT00957034|E1|Reported Event|Placebo|placebo patch
416563|NCT00957021|B1|Baseline|Triathlon® PS Total Knee System|Participants who were not censored from analysis.
416564|NCT00957021|P1|Participant Flow|Triathlon® PS Total Knee System|If both knees were replaced, but only one knee completed the study, the participant is counted as completed.
416565|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
416566|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
416567|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
416568|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
416569|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
416629|NCT00956839|E3|Reported Event|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
416630|NCT00956839|E2|Reported Event|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
416570|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
416571|NCT00957021|E1|Reported Event|Triathlon® PS Total Knee System|All non-censored participants who received the Triathlon® PS Total Knee System.
416572|NCT00957008|B5|Baseline|Total|Total of all reporting groups
416573|NCT00957008|B4|Baseline|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
416574|NCT00957008|B3|Baseline|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
416575|NCT00957008|B2|Baseline|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
416576|NCT00957008|B1|Baseline|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
416577|NCT00957008|P4|Participant Flow|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
416578|NCT00957008|P3|Participant Flow|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
416579|NCT00957008|P2|Participant Flow|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
416580|NCT00957008|P1|Participant Flow|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
416581|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
416582|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
416583|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
416584|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
416585|NCT00957008|O4|Outcome|D - Standard Care|Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
416597|NCT00957008|O4|Outcome|D - Standard Care|Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
416631|NCT00956839|E1|Reported Event|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
416632|NCT00956813|B3|Baseline|Total|Total of all reporting groups
416633|NCT00956813|B2|Baseline|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416586|NCT00957008|O3|Outcome|C - SWA Alone|"Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband."
416587|NCT00957008|O2|Outcome|B - GWL+SWA|"Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning"
416588|NCT00957008|O1|Outcome|A - GWL|"Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.~Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual."
416589|NCT00957008|O4|Outcome|D - Standard Care|Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
416590|NCT00957008|O3|Outcome|C - SWA Alone|"Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband."
416591|NCT00957008|O2|Outcome|B - GWL+SWA|"Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning"
416592|NCT00957008|O1|Outcome|A - GWL|"Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.~Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual."
416593|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
416594|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
416595|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
416596|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
416625|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
416626|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
416598|NCT00957008|O3|Outcome|C - SWA Alone|"Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband."
416599|NCT00957008|O2|Outcome|B - GWL+SWA|"Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.~Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning"
416600|NCT00957008|O1|Outcome|A - GWL|"Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.~Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual."
416601|NCT00957008|E4|Reported Event|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
416602|NCT00957008|E3|Reported Event|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
416603|NCT00957008|E2|Reported Event|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
416604|NCT00957008|E1|Reported Event|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
416605|NCT00956943|B3|Baseline|Total|Total of all reporting groups
416606|NCT00956943|B2|Baseline|42mg Transdermal Nicotine|
416607|NCT00956943|B1|Baseline|21mg Transdermal Nicotine + Placebo Patch|
416608|NCT00956943|P2|Participant Flow|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
416609|NCT00956943|P1|Participant Flow|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
416610|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
416611|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
416612|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
416613|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
416614|NCT00956943|E2|Reported Event|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
416615|NCT00956943|E1|Reported Event|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
416616|NCT00956839|B4|Baseline|Total|Total of all reporting groups
416617|NCT00956839|B3|Baseline|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
416618|NCT00956839|B2|Baseline|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
416619|NCT00956839|B1|Baseline|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
416620|NCT00956839|P3|Participant Flow|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
416621|NCT00956839|P2|Participant Flow|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
416622|NCT00956839|P1|Participant Flow|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
416623|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
416624|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
416634|NCT00956813|B1|Baseline|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416635|NCT00956813|P2|Participant Flow|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416636|NCT00956813|P1|Participant Flow|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416637|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416638|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416639|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416640|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416641|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416642|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416643|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416644|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416645|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416646|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416647|NCT00956813|E3|Reported Event|Optional Continuation Period|After completing the Placebo/Flaxseed double-blind period, patients were allowed to continue with 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416648|NCT00956813|E2|Reported Event|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
416649|NCT00956813|E1|Reported Event|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
416650|NCT00956761|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
416651|NCT00956761|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
416652|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
416653|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
416654|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
416655|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
416656|NCT00956761|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
416657|NCT00956709|B3|Baseline|Total|Total of all reporting groups
416658|NCT00956709|B2|Baseline|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
416659|NCT00956709|B1|Baseline|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
416660|NCT00956709|P2|Participant Flow|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
416661|NCT00956709|P1|Participant Flow|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
416662|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
416663|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
416664|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
416665|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
416666|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
416667|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
416668|NCT00956709|E2|Reported Event|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
416669|NCT00956709|E1|Reported Event|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
416670|NCT00956657|B3|Baseline|Total|Total of all reporting groups
416671|NCT00956657|B2|Baseline|Treatment As Usual|Control group. Treatment received as usual.
416672|NCT00956657|B1|Baseline|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
416673|NCT00956657|P2|Participant Flow|Treatment As Usual|Control group. Treatment received as usual.
416674|NCT00956657|P1|Participant Flow|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
416675|NCT00956657|O2|Outcome|Treatment As Usual|Control group. Treatment received as usual.
416676|NCT00956657|O1|Outcome|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
416677|NCT00956657|E2|Reported Event|Treatment As Usual|Control group. Treatment received as usual.
416678|NCT00956657|E1|Reported Event|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
416679|NCT00956631|B1|Baseline|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
416680|NCT00956631|P1|Participant Flow|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
416681|NCT00956631|O1|Outcome|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated using the mild® device kit in a percutaneous lumbar decompression procedure.
416682|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous lumbar decompression with the mild device kit.
416683|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous decompression with the mild device kit.
416684|NCT00956631|E1|Reported Event|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
416685|NCT00956592|B3|Baseline|Total|Total of all reporting groups
416686|NCT00956592|B2|Baseline|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
416687|NCT00956592|B1|Baseline|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
416688|NCT00956592|P2|Participant Flow|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
416689|NCT00956592|P1|Participant Flow|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
416690|NCT00956592|O2|Outcome|Macintosh Blade|"Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade~Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade"
416691|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|"Subjects will have their intubation attempted first with the CMAC video laryngoscope~CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement"
416692|NCT00956592|O2|Outcome|Macintosh Blade|"Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade~Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade"
416693|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|"Subjects will have their intubation attempted first with the CMAC video laryngoscope~CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement"
416694|NCT00956592|O2|Outcome|Macintosh Blade|"Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade~Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade"
416695|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|"Subjects will have their intubation attempted first with the CMAC video laryngoscope~CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement"
416696|NCT00956592|O2|Outcome|Macintosh Blade|"Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade~Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade"
416697|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|"Subjects will have their intubation attempted first with the CMAC video laryngoscope~CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement"
416698|NCT00956592|O2|Outcome|Macintosh Blade|"Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade~Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade"
416699|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|"Subjects will have their intubation attempted first with the CMAC video laryngoscope~CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement"
416700|NCT00956592|O2|Outcome|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
416701|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
416702|NCT00956592|E2|Reported Event|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
416703|NCT00956592|E1|Reported Event|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
416704|NCT00956540|B5|Baseline|Total|Total of all reporting groups
416705|NCT00956540|B4|Baseline|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
416706|NCT00956540|B3|Baseline|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
416707|NCT00956540|B2|Baseline|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
416708|NCT00956540|B1|Baseline|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
416709|NCT00956540|P4|Participant Flow|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
416710|NCT00956540|P3|Participant Flow|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
416711|NCT00956540|P2|Participant Flow|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
416712|NCT00956540|P1|Participant Flow|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
416713|NCT00956540|O4|Outcome|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
416714|NCT00956540|O3|Outcome|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
416715|NCT00956540|O2|Outcome|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
416716|NCT00956540|O1|Outcome|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
416717|NCT00956540|E4|Reported Event|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
416718|NCT00956540|E3|Reported Event|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
416719|NCT00956540|E2|Reported Event|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
416720|NCT00956540|E1|Reported Event|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
416721|NCT00956293|B3|Baseline|Total|Total of all reporting groups
416722|NCT00956293|B2|Baseline|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416723|NCT00956293|B1|Baseline|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416724|NCT00956293|P3|Participant Flow|Pre-randomized Group|Participants, who met BL1 eligibility, were enrolled into the study.
416725|NCT00956293|P2|Participant Flow|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416726|NCT00956293|P1|Participant Flow|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416727|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416728|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416729|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416730|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416755|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416731|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416732|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416733|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416734|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416735|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416736|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416737|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416738|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416739|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416740|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416741|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416742|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416743|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416744|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416745|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416746|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416747|NCT00956293|E2|Reported Event|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
416748|NCT00956293|E1|Reported Event|Control Goup|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
416749|NCT00956254|B1|Baseline|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416750|NCT00956254|P1|Participant Flow|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416751|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416752|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416753|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416754|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
419239|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
416756|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416757|NCT00956254|E2|Reported Event|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416758|NCT00956254|E1|Reported Event|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
416759|NCT00956085|B1|Baseline|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
416760|NCT00956085|P1|Participant Flow|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
416761|NCT00956085|O1|Outcome|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response, either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
416762|NCT00956085|E1|Reported Event|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
416763|NCT00956020|B1|Baseline|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416764|NCT00956020|P1|Participant Flow|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416765|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416766|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416767|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416768|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416769|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416770|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 30 minutes after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416771|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416772|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416773|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
416774|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416775|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
416776|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416777|NCT00956020|E1|Reported Event|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
416778|NCT00955968|B3|Baseline|Total|Total of all reporting groups
416779|NCT00955968|B2|Baseline|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416780|NCT00955968|B1|Baseline|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416781|NCT00955968|P2|Participant Flow|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416782|NCT00955968|P1|Participant Flow|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416783|NCT00955968|O2|Outcome|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416784|NCT00955968|O1|Outcome|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416785|NCT00955968|O2|Outcome|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416786|NCT00955968|O1|Outcome|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416787|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome
416788|NCT00955968|O2|Outcome|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416789|NCT00955968|O1|Outcome|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416790|NCT00955968|O2|Outcome|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416791|NCT00955968|O1|Outcome|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416792|NCT00955968|O2|Outcome|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416793|NCT00955968|O1|Outcome|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416794|NCT00955968|O2|Outcome|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416795|NCT00955968|O1|Outcome|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416796|NCT00955968|O2|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416797|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416798|NCT00955968|O2|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416799|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416800|NCT00955968|O2|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416801|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416802|NCT00955968|O2|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416803|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416804|NCT00955968|O2|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416805|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416806|NCT00955968|O2|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416807|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416808|NCT00955968|O2|Outcome|Stop HAART|Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
416809|NCT00955968|O1|Outcome|Continue HAART|Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
416810|NCT00955968|E2|Reported Event|Stop HAART|"Participants would stop receiving HAART after delivery or other pregnancy outcome and resume when protocol-specified criteria were met.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416811|NCT00955968|E1|Reported Event|Continue HAART|"Participants would continue receiving HAART after delivery or other pregnancy outcome.~Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes"
416812|NCT00955955|B4|Baseline|Total|Total of all reporting groups
416813|NCT00955955|B3|Baseline|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
416814|NCT00955955|B2|Baseline|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
416815|NCT00955955|B1|Baseline|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
416816|NCT00955955|P3|Participant Flow|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
416817|NCT00955955|P2|Participant Flow|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
416818|NCT00955955|P1|Participant Flow|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
416819|NCT00955955|O4|Outcome|Adjunct Placebo Phase II|Patients received placebo for the second 4 weeks of the study. Patients who received placebo in phase 2 also received it in phase 1.
416820|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase II|Patients received Deplin for 4 weeks.
416821|NCT00955955|O2|Outcome|Adjunct Placebo Phase I|Patients who received placebo for 4 weeks.
416822|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase I|Patients who received Deplin (L-methylfolate) for 4 weeks
416823|NCT00955955|O6|Outcome|Pooled Placebo|Patients in this group received placebo at some point during the study. Results are pooled from phase I and II.
416824|NCT00955955|O5|Outcome|Pooled Deplin|Patients in this group received Deplin at some point during the study. Results are pooled from phase I and II.
416825|NCT00955955|O4|Outcome|Adjunct Placebo Phase 2|Patients in this group received placebo in both phases of the study for a total of 8 weeks,
416826|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 2|Participants will receive 15 mg of Deplin (6(S)-5-MTHF) for 4 weeks.
416827|NCT00955955|O2|Outcome|Adjunct Placebo Phase 1|Participants will receive placebo for the first 4 weeks
416828|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 1|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 4 weeks.
416829|NCT00955955|E2|Reported Event|Placebo|Adverse events for participants who received placebo during the study.
416830|NCT00955955|E1|Reported Event|Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF).
416831|NCT00955916|B1|Baseline|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
416832|NCT00955916|P1|Participant Flow|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
416833|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
416834|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
416835|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
416836|NCT00955916|E1|Reported Event|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
416837|NCT00955903|B4|Baseline|Total|Total of all reporting groups
416838|NCT00955903|B3|Baseline|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
416839|NCT00955903|B2|Baseline|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
416840|NCT00955903|B1|Baseline|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
416841|NCT00955903|P3|Participant Flow|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
416842|NCT00955903|P2|Participant Flow|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
416843|NCT00955903|P1|Participant Flow|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
416844|NCT00955903|O3|Outcome|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
416845|NCT00955903|O2|Outcome|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
416846|NCT00955903|O1|Outcome|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
416847|NCT00955903|O3|Outcome|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
416848|NCT00955903|O2|Outcome|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
416849|NCT00955903|O1|Outcome|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
416850|NCT00955903|O3|Outcome|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
416851|NCT00955903|O2|Outcome|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
416852|NCT00955903|O1|Outcome|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
416853|NCT00955903|E3|Reported Event|Weight Maintenance|"Participants receive Exercise Only and a Weight Maintenance Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Weight Maintenance Diet: Participants will follow a weight maintenance diet"
416854|NCT00955903|E2|Reported Event|Control|"Participants receive Exercise Only Intervention~Exercise Only: Participants will participate in supervised exercise sessions"
416855|NCT00955903|E1|Reported Event|Weight Loss|"Participants receive Exercise Only and Reduced Calorie Diet Interventions~Exercise Only: Participants will participate in supervised exercise sessions~Reduced Calorie Diet: Participants will follow a reduced calorie diet"
416856|NCT00955825|B3|Baseline|Total|Total of all reporting groups
416857|NCT00955825|B2|Baseline|Placebo|Placebo tablet
416858|NCT00955825|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
416859|NCT00955825|P2|Participant Flow|Placebo|Placebo tablet
416860|NCT00955825|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
416861|NCT00955825|O2|Outcome|Placebo|Placebo tablet
416862|NCT00955825|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
416863|NCT00955825|E2|Reported Event|Placebo|Placebo tablet
416864|NCT00955825|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
416865|NCT00955747|B3|Baseline|Total|Total of all reporting groups
416866|NCT00955747|B2|Baseline|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
416867|NCT00955747|B1|Baseline|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
416868|NCT00955747|P2|Participant Flow|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
416869|NCT00955747|P1|Participant Flow|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
416870|NCT00955747|O2|Outcome|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
416871|NCT00955747|O1|Outcome|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
416872|NCT00955747|E2|Reported Event|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
416873|NCT00955747|E1|Reported Event|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
416874|NCT00955721|B3|Baseline|Total|Total of all reporting groups
416875|NCT00955721|B2|Baseline|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416876|NCT00955721|B1|Baseline|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416877|NCT00955721|P2|Participant Flow|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416878|NCT00955721|P1|Participant Flow|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416879|NCT00955721|O1|Outcome|Phase 2 - RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.~Gemcitabine: Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416880|NCT00955721|O1|Outcome|Phase 2 - RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.~Gemcitabine: Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416881|NCT00955721|O1|Outcome|Phase 2 - RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.~Gemcitabine: Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416882|NCT00955721|O1|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416883|NCT00955721|O1|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416884|NCT00955721|O1|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib.~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.~Gemcitabine: Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416885|NCT00955721|E2|Reported Event|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416886|NCT00955721|E1|Reported Event|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
416887|NCT00955617|B1|Baseline|All Patients|All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population.
416888|NCT00955617|P2|Participant Flow|Gadovist Then Dotarem|Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2)
416889|NCT00955617|P1|Participant Flow|Dotarem Then Gadovist|Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2)
416890|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
416891|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
416892|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
416893|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
416894|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
416895|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
416896|NCT00955617|E2|Reported Event|Gadovist MRA|Patients who received a Gadovist enhanced-MRA
416897|NCT00955617|E1|Reported Event|Dotarem MRA|Patients who received a Dotarem enhanced-MRA
416898|NCT00955513|B4|Baseline|Total|Total of all reporting groups
416899|NCT00955513|B3|Baseline|Placebo. Applied 3 Times a Day.|placebo
416900|NCT00955513|B2|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
416901|NCT00955513|B1|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
416902|NCT00955513|P3|Participant Flow|Placebo. Applied 3 Times a Day.|placebo
416903|NCT00955513|P2|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
416904|NCT00955513|P1|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
416905|NCT00955513|O3|Outcome|Placebo. Applied 3 Times a Day.|placebo
416906|NCT00955513|O2|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
416907|NCT00955513|O1|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
416908|NCT00955513|E3|Reported Event|Placebo. Applied 3 Times a Day.|placebo
416909|NCT00955513|E2|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
416910|NCT00955513|E1|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
416911|NCT00955487|B3|Baseline|Total|Total of all reporting groups
416912|NCT00955487|B2|Baseline|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416913|NCT00955487|B1|Baseline|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416914|NCT00955487|P6|Participant Flow|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416915|NCT00955487|P5|Participant Flow|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416916|NCT00955487|P4|Participant Flow|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416917|NCT00955487|P3|Participant Flow|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416918|NCT00955487|P2|Participant Flow|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416919|NCT00955487|P1|Participant Flow|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416920|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416921|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416922|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416923|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416924|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416925|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416926|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
417042|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
416927|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416928|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416929|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416930|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416931|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416932|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416933|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416934|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416935|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416936|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416937|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416938|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416939|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416940|NCT00955487|O6|Outcome|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416941|NCT00955487|O5|Outcome|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416942|NCT00955487|O4|Outcome|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416943|NCT00955487|O3|Outcome|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416944|NCT00955487|O2|Outcome|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416945|NCT00955487|O1|Outcome|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
416946|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416947|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
417043|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
418565|NCT00951171|O2|Outcome|Standard IUI|Insemination with TOmcat catheter
416948|NCT00955487|E2|Reported Event|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416949|NCT00955487|E1|Reported Event|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
416950|NCT00955474|B3|Baseline|Total|Total of all reporting groups
416951|NCT00955474|B2|Baseline|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416952|NCT00955474|B1|Baseline|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416953|NCT00955474|P2|Participant Flow|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416954|NCT00955474|P1|Participant Flow|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416955|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416956|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416957|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416958|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416968|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416959|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416960|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416961|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416962|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416963|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416964|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416965|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416966|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416967|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
417004|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
417109|NCT00954915|O1|Outcome|Teplizumab|anti-CD3 monoclonal antibody
416969|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416970|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416971|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416972|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416973|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416974|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416975|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416976|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416977|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
417005|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
417110|NCT00954915|E1|Reported Event|Teplizumab|Anti CD-3 monoclonal antibody
416978|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416979|NCT00955474|O2|Outcome|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416980|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416981|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416982|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416983|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416984|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416985|NCT00955474|E2|Reported Event|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
416986|NCT00955474|E1|Reported Event|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
416987|NCT00955357|B3|Baseline|Total|Total of all reporting groups
416988|NCT00955357|B2|Baseline|Later-Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
418717|NCT00950937|P1|Participant Flow|HIV Group|HIV infected persons
416989|NCT00955357|B1|Baseline|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
416990|NCT00955357|P2|Participant Flow|Later Add-on|"Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
416991|NCT00955357|P1|Participant Flow|First Add-on|"Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
416992|NCT00955357|O2|Outcome|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
416993|NCT00955357|O1|Outcome|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
416994|NCT00955357|E2|Reported Event|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
416995|NCT00955357|E1|Reported Event|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
416996|NCT00955305|B3|Baseline|Total|Total of all reporting groups
416997|NCT00955305|B2|Baseline|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
416998|NCT00955305|B1|Baseline|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
416999|NCT00955305|P2|Participant Flow|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
417000|NCT00955305|P1|Participant Flow|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
417001|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
417002|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
417003|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
418718|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
417006|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
417007|NCT00955305|E2|Reported Event|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
417008|NCT00955305|E1|Reported Event|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
417009|NCT00955279|B4|Baseline|Total|Total of all reporting groups
417010|NCT00955279|B3|Baseline|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417011|NCT00955279|B2|Baseline|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417012|NCT00955279|B1|Baseline|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417013|NCT00955279|P3|Participant Flow|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417014|NCT00955279|P2|Participant Flow|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417015|NCT00955279|P1|Participant Flow|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417016|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417017|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417018|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417019|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417020|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417021|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417022|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417023|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417024|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417025|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417026|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417027|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417028|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417029|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417030|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417031|NCT00955279|E3|Reported Event|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
417032|NCT00955279|E2|Reported Event|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
417033|NCT00955279|E1|Reported Event|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
417034|NCT00955266|B3|Baseline|Total|Total of all reporting groups
417035|NCT00955266|B2|Baseline|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
417036|NCT00955266|B1|Baseline|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
417037|NCT00955266|P2|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
417038|NCT00955266|P1|Participant Flow|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
417039|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
417040|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
417041|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
417044|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
417045|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
417046|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
417047|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
417048|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
417049|NCT00955266|E2|Reported Event|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
417050|NCT00955266|E1|Reported Event|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
417051|NCT00955110|B1|Baseline|All Subjects Randomized to Treatment Phase|Forty one (41) qualified subjects were randomized into the treatment phase (Randomized population). Subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.
417052|NCT00955110|P1|Participant Flow|All Subjects|"Subjects enrolled were healthy non-dependent recreational opioid users. During the Treatment Phase, subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.~All participants did not necessarily receive the 5 drug interventions in the order reported as Milestones."
417053|NCT00955110|O5|Outcome|Oxycodone CR 60 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 60 mg.
417054|NCT00955110|O4|Outcome|Oxycodone CR 30 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 30 mg.
417055|NCT00955110|O3|Outcome|Oxymorphone ER 30 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 30 mg.
417056|NCT00955110|O2|Outcome|Oxymorphone ER 15 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 15 mg.
417057|NCT00955110|O1|Outcome|Placebo|Subjects received a single oral dose (1 capsule) of placebo.
417058|NCT00955110|E5|Reported Event|Treatment Phase Oxycodone CR 60 mg|Single oral dose (1 capsule) of Oxycodone HCl CR 60 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
417059|NCT00955110|E4|Reported Event|Treatment Phase Oxycodone CR 30mg|Single oral dose (1 capsule) of Oxycodone HCl CR 30 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
417060|NCT00955110|E3|Reported Event|Treatment Phase Oxymorphone ER 30mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 30 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
417061|NCT00955110|E2|Reported Event|Treatment Phase Oxymorphone ER 15 mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 15 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
417062|NCT00955110|E1|Reported Event|Treatment Phase Placebo|Identical placebo capsules using size AA Swedish orange capsules and microcrystalline cellulose.
417063|NCT00955032|B3|Baseline|Total|Total of all reporting groups
417064|NCT00955032|B2|Baseline|Sham Treatment|Participants in this group did not receive rTMS treatment.
417065|NCT00955032|B1|Baseline|rTMS Treatment|Participants in this group received rTMS treatment.
417066|NCT00955032|P2|Participant Flow|Sham Treatment|Participants in this group did not receive rTMS treatment.
417067|NCT00955032|P1|Participant Flow|rTMS Treatment|Participants in this group received rTMS treatment.
417068|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
417069|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
417070|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received sham treatment.
417071|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
417072|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
417073|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
417074|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received Sham tx.
417075|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
417076|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
417077|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
417078|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed prior to receiving Sham treatment.
417079|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group received were assessed prior to receiving rTMS treatment.
417080|NCT00955032|O4|Outcome|Sham Post Tx (Immediate)|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
417081|NCT00955032|O3|Outcome|rTMS Post TX (Immediate)|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
417082|NCT00955032|O2|Outcome|Sham Pre TX|Participants in this group were assessed before sham treatment.
417083|NCT00955032|O1|Outcome|rTMS Pre TX|Participants in this group were assessed prior to rTMS treatment.
417084|NCT00955032|E2|Reported Event|Sham Treatment|Participants in this group did not receive rTMS treatment.
417085|NCT00955032|E1|Reported Event|rTMS Treatment|Participants in this group received rTMS treatment.
417111|NCT00954824|B1|Baseline|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
417086|NCT00954993|B1|Baseline|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
417087|NCT00954993|P1|Participant Flow|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
417088|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
417089|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
417090|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
417091|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
417092|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
417093|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
417094|NCT00954993|E2|Reported Event|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
417095|NCT00954993|E1|Reported Event|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
417096|NCT00954941|B3|Baseline|Total|Total of all reporting groups
417097|NCT00954941|B2|Baseline|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
417098|NCT00954941|B1|Baseline|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
417099|NCT00954941|P2|Participant Flow|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
417100|NCT00954941|P1|Participant Flow|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
417101|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
417102|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
417103|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
417104|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
417105|NCT00954941|E2|Reported Event|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
417106|NCT00954941|E1|Reported Event|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
417107|NCT00954915|B1|Baseline|Teplizumab|Anti CD-3 monoclonal antibody
417108|NCT00954915|P1|Participant Flow|Teplizumab|Anti CD-3 monoclonal antibody
417112|NCT00954824|P1|Participant Flow|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
417113|NCT00954824|O1|Outcome|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
417114|NCT00954824|E1|Reported Event|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
417115|NCT00954733|B1|Baseline|All Participants|All participants in the study
417116|NCT00954733|P1|Participant Flow|All Participants|All participants undergoing surgery
417117|NCT00954733|O1|Outcome|All Participants|All participants undergoing surgery
417118|NCT00954733|E1|Reported Event|All Participants|All participants undergoing surgery
417119|NCT00954707|B1|Baseline|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417120|NCT00954707|P1|Participant Flow|All Enrolled Subjects|Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria.
417121|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417122|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417123|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417124|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417125|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417126|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417127|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417128|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417129|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417130|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417131|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417162|NCT00954512|B2|Baseline|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417750|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417132|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417133|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417134|NCT00954707|E1|Reported Event|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
417135|NCT00954681|B1|Baseline|Quetiapine Treatment|"Open label treatment with quetiapine~quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily"
417136|NCT00954681|P1|Participant Flow|Quetiapine Treatment|"Open label treatment with quetiapine~quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily"
417137|NCT00954681|O1|Outcome|Open-Label Quetiapine Treatment|Participants receiving quetiapine under open-label conditions.
417138|NCT00954681|E1|Reported Event|Quetiapine Treatment|"Open label treatment with quetiapine~quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily"
417139|NCT00954538|B3|Baseline|Total|Total of all reporting groups
417140|NCT00954538|B2|Baseline|AD Participants (Part II/III)|This group includes AD participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of brain
417141|NCT00954538|B1|Baseline|Healthy Participants (Part I) + HE Participants (Part II/III)|This group includes Healthy participants (Part I) and HE participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
417142|NCT00954538|P6|Participant Flow|HE Participants (Part II + III)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II) / HE Participants who completed Part II could receive a second IV dose of ~150 MBq [18F]MK-3328 in Part III; this dose was followed by PET imaging of the brain
417143|NCT00954538|P5|Participant Flow|AD Participants (Part III Only)|AD participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
417144|NCT00954538|P4|Participant Flow|HE Participants (Part III Only)|HE participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
417145|NCT00954538|P3|Participant Flow|Alzheimer's Disease (AD) Participants (Part II Only)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
417146|NCT00954538|P2|Participant Flow|Healthy Elderly (HE) Participants (Part II Only)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
417147|NCT00954538|P1|Participant Flow|Healthy Participants (Part I Only)|Healthy participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by Positron Emission Tomography (PET) imaging of the whole body (Part I)
417148|NCT00954538|O2|Outcome|HE Participants (Part III)|HE participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
417149|NCT00954538|O1|Outcome|AD Participants (Part III)|AD participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
417150|NCT00954538|O2|Outcome|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
417151|NCT00954538|O1|Outcome|AD Participants (Part II)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
417152|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
417153|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
417154|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
417155|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
417156|NCT00954538|E1|Reported Event|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
417157|NCT00954512|B7|Baseline|Total|Total of all reporting groups
417158|NCT00954512|B6|Baseline|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
417159|NCT00954512|B5|Baseline|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417160|NCT00954512|B4|Baseline|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417161|NCT00954512|B3|Baseline|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
418719|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
417163|NCT00954512|B1|Baseline|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
417164|NCT00954512|P6|Participant Flow|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
417165|NCT00954512|P5|Participant Flow|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417166|NCT00954512|P4|Participant Flow|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417167|NCT00954512|P3|Participant Flow|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417168|NCT00954512|P2|Participant Flow|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417169|NCT00954512|P1|Participant Flow|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
417170|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
417171|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417172|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417173|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417174|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417175|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
417176|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
417177|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417178|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417179|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417180|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417181|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
417182|NCT00954512|E5|Reported Event|Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 on Days 1, 8, 15, 22, 29, 36, and 43 (± erlotinib 100 mg per day) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 8 weeks.
417183|NCT00954512|E4|Reported Event|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417184|NCT00954512|E3|Reported Event|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
417185|NCT00954512|E2|Reported Event|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
417621|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
417186|NCT00954512|E1|Reported Event|Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 followed by once-weekly doses of 250 mg/m^2) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 2 weeks.
417187|NCT00954447|B3|Baseline|Total|Total of all reporting groups
417188|NCT00954447|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417189|NCT00954447|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417190|NCT00954447|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417191|NCT00954447|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417192|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417193|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417194|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417195|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417196|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417197|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417198|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417199|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417200|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417201|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417202|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417203|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417204|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417205|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417206|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417207|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417208|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417209|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417210|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417211|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417212|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417213|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417214|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417215|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417216|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417217|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417218|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417219|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417220|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
418720|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
417221|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417222|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417223|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417224|NCT00954447|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417225|NCT00954447|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
417226|NCT00954421|B1|Baseline|All Subjects|All eligible subjects were enrolled and the intent was to treat for six months on dual lead deep brain stimulation in the VIM and VO regions.
417227|NCT00954421|P1|Participant Flow|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
417228|NCT00954421|O2|Outcome|TRS Scale Vo Only on vs. Vim Only on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Vo only on -VM only on at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
417229|NCT00954421|O1|Outcome|TRS Scale Both Off vs Both on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Both OFF- Both On) at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
417230|NCT00954421|O1|Outcome|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
417231|NCT00954421|E1|Reported Event|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
417232|NCT00954356|B3|Baseline|Total|Total of all reporting groups
417233|NCT00954356|B2|Baseline|Placebo|5 x matching placebo capsules (administered as a single dose)
417234|NCT00954356|B1|Baseline|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
417235|NCT00954356|P2|Participant Flow|Placebo|5 x matching placebo capsules (administered as a single dose)
417236|NCT00954356|P1|Participant Flow|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
417237|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417238|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417239|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417240|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417241|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417242|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417742|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417243|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417244|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417245|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417246|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417247|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417248|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417249|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417250|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417251|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417252|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417253|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417254|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417255|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417256|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417257|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417258|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417259|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417260|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
417261|NCT00954356|E2|Reported Event|Placebo|5 x matching placebo capsules (administered as a single dose)
417262|NCT00954356|E1|Reported Event|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
417263|NCT00954187|B3|Baseline|Total|Total of all reporting groups
417264|NCT00954187|B2|Baseline|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
417265|NCT00954187|B1|Baseline|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
417266|NCT00954187|P2|Participant Flow|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
417267|NCT00954187|P1|Participant Flow|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
417268|NCT00954187|O2|Outcome|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
417269|NCT00954187|O1|Outcome|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
417270|NCT00954187|E2|Reported Event|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
417271|NCT00954187|E1|Reported Event|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
417272|NCT00954122|B1|Baseline|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
417273|NCT00954122|P1|Participant Flow|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
417274|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
417743|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417275|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
417276|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
417277|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
417278|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
417279|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
417280|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
417281|NCT00954122|E1|Reported Event|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
417282|NCT00954109|B1|Baseline|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
417283|NCT00954109|P1|Participant Flow|Exercise|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
417284|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
417285|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
417286|NCT00954109|E1|Reported Event|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
417287|NCT00953927|B3|Baseline|Total|Total of all reporting groups
417288|NCT00953927|B2|Baseline|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417289|NCT00953927|B1|Baseline|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417290|NCT00953927|P2|Participant Flow|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417291|NCT00953927|P1|Participant Flow|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417292|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417293|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417294|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417295|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417296|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417297|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417298|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417299|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417300|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417301|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417302|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417303|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417304|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417305|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417306|NCT00953927|E2|Reported Event|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
417307|NCT00953927|E1|Reported Event|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
417308|NCT00953862|B1|Baseline|Treatment|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
417328|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
417329|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
417309|NCT00953862|P1|Participant Flow|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
417310|NCT00953862|O1|Outcome|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
417311|NCT00953862|O1|Outcome|Atomoxetine Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
417312|NCT00953862|O1|Outcome|Atomoxetine Arm|Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline. Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.
417313|NCT00953862|E1|Reported Event|Treatment Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
417314|NCT00953849|B5|Baseline|Total|Total of all reporting groups
417315|NCT00953849|B4|Baseline|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
417316|NCT00953849|B3|Baseline|Arm 3: Celecoxib Plus Calcitriol|Celecoxib + Calcitriol 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg 1,25-dihydroxyvitamin D3) for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
417317|NCT00953849|B2|Baseline|Arm 2: Calcitriol|Calcitriol Calcitriol (1,25-dihydroxyvitamin D3): 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment)
417318|NCT00953849|B1|Baseline|Arm 1: Celecoxib|"Celecoxib:~Celecoxib (400 mg twice daily) oral cancer patients receiving new immunotherapy prior to surgery"
417319|NCT00953849|P4|Participant Flow|Arm 4: No Treatment|no treatment prior to surgery
417320|NCT00953849|P3|Participant Flow|Arm 3: Celecoxib Plus Calcitriol|Treatment with Celecoxib + Calcitriol
417321|NCT00953849|P2|Participant Flow|Arm 2: Calcitriol|Treatment with Calcitriol
417322|NCT00953849|P1|Participant Flow|Arm 1: Celecoxib|Treatment with Celecoxib
417323|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
417324|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
417325|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
417326|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
417327|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
417354|NCT00953719|B3|Baseline|Total|Total of all reporting groups
417330|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
417331|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
417332|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
417333|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
417334|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
417335|NCT00953849|O4|Outcome|Arm 4: No Treatment|no treatment prior to surgery
417336|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"Treatment with Celecoxib plus Calcitriol prior to surgery.~Celecoxib plus Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)"
417337|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"Treatment with Calcitriol prior to surgery~Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)"
417338|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"Celecoxib treatment prior to surgery~Celecoxib: Celecoxib (400 mg twice daily)"
417339|NCT00953849|E4|Reported Event|Arm 4: No Treatment|oral cancer patients receiving no treatment prior to surgery
417340|NCT00953849|E3|Reported Event|Arm 3: Celecoxib Plus Calcitriol|oral cancer patients receiving Celecoxib + Calcitriol prior to surgery
417341|NCT00953849|E2|Reported Event|Arm 2: Calcitriol|oral cancer patients receiving Calcitriol prior to surgery
417342|NCT00953849|E1|Reported Event|Arm 1: Celecoxib|oral cancer patients receiving Celecoxib prior to surgery
417343|NCT00953745|B3|Baseline|Total|Total of all reporting groups
417344|NCT00953745|B2|Baseline|Control Participants|Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).
417345|NCT00953745|B1|Baseline|Depressed Participants|"Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.~Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks.~Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
417346|NCT00953745|P2|Participant Flow|Control Participants|Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).
417347|NCT00953745|P1|Participant Flow|Depressed Participants|"Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.~Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks."
417348|NCT00953745|O2|Outcome|ARP Non-Responders|Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP non-responders will not have had a 50% or greater drop in their MADRS scores from baseline.
417349|NCT00953745|O1|Outcome|ARP Responders|Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP Responders will have had a 50% or greater drop in their MADRS scores from baseline.
417350|NCT00953745|O2|Outcome|ARP Non-Responders|"Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP Responders will have had a 50% or greater drop in their MADRS scores from baseline.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
417351|NCT00953745|O1|Outcome|ARP Responders|"Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP. ARP Responders will have had a 50% or greater drop in their MADRS scores from baseline.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
417352|NCT00953745|E2|Reported Event|Control Participants|Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).
417353|NCT00953745|E1|Reported Event|Depressed Participants|"Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.~Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks.~Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP.~Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment."
417355|NCT00953719|B2|Baseline|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417356|NCT00953719|B1|Baseline|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417357|NCT00953719|P2|Participant Flow|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417358|NCT00953719|P1|Participant Flow|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417359|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417360|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417361|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417362|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417363|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417364|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417365|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417366|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417367|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417368|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417369|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417370|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417371|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417372|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417373|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417374|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417375|NCT00953719|E2|Reported Event|28 mm Ceramic-on-polyethylene|28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
417376|NCT00953719|E1|Reported Event|36 mm Ceramic-on-ceramic|36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner
417377|NCT00953706|B3|Baseline|Total|Total of all reporting groups
417378|NCT00953706|B2|Baseline|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417379|NCT00953706|B1|Baseline|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
417380|NCT00953706|P4|Participant Flow|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417381|NCT00953706|P3|Participant Flow|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417382|NCT00953706|P2|Participant Flow|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417383|NCT00953706|P1|Participant Flow|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
417384|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417385|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417386|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417744|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417387|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417388|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417389|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417390|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417391|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417392|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417393|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417394|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417395|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417396|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417397|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417398|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417399|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417400|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417401|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417402|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417403|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417404|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417405|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417406|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417407|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417408|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417409|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417410|NCT00953706|E4|Reported Event|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417411|NCT00953706|E3|Reported Event|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
417412|NCT00953706|E2|Reported Event|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417413|NCT00953706|E1|Reported Event|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
417414|NCT00953680|B1|Baseline|All Participants|All randomized patients
417415|NCT00953680|P2|Participant Flow|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
417416|NCT00953680|P1|Participant Flow|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
417417|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
417418|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
417419|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
417420|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
417421|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
417422|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
417423|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
417424|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
417456|NCT00953524|B4|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417425|NCT00953680|E2|Reported Event|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
417426|NCT00953680|E1|Reported Event|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
417427|NCT00953667|B1|Baseline|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
417428|NCT00953667|P1|Participant Flow|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
417429|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
417430|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
417431|NCT00953667|E1|Reported Event|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
417432|NCT00953654|B4|Baseline|Total|Total of all reporting groups
417433|NCT00953654|B3|Baseline|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
417434|NCT00953654|B2|Baseline|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
417435|NCT00953654|B1|Baseline|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
417436|NCT00953654|P3|Participant Flow|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
417437|NCT00953654|P2|Participant Flow|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
417438|NCT00953654|P1|Participant Flow|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
417439|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
417440|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
417441|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
417442|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
417443|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
417444|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
417445|NCT00953654|E3|Reported Event|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
417446|NCT00953654|E2|Reported Event|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
417447|NCT00953654|E1|Reported Event|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
417448|NCT00953615|B1|Baseline|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
417449|NCT00953615|P1|Participant Flow|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
417450|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
417451|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
417452|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
417453|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
417454|NCT00953615|E1|Reported Event|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
417455|NCT00953524|B5|Baseline|Total|Total of all reporting groups
417745|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417457|NCT00953524|B3|Baseline|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417458|NCT00953524|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417459|NCT00953524|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417460|NCT00953524|P4|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417461|NCT00953524|P3|Participant Flow|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417462|NCT00953524|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417463|NCT00953524|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417464|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417465|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417466|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417467|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417468|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417469|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417470|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417471|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417472|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417473|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417474|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417475|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417476|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417477|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417478|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417479|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417480|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417481|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417482|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417483|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417484|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417485|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417486|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417487|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417488|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417489|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417490|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417491|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417492|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417493|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417494|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417495|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417496|NCT00953524|E4|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
417746|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417497|NCT00953524|E3|Reported Event|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417498|NCT00953524|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
417499|NCT00953524|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
417500|NCT00953407|B6|Baseline|Total|Total of all reporting groups
417501|NCT00953407|B5|Baseline|Hilafilcon B|Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis
417502|NCT00953407|B4|Baseline|Omafilcon A|Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis
417503|NCT00953407|B3|Baseline|Etafilcon A|Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis
417504|NCT00953407|B2|Baseline|Narafilcon A|Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis
417505|NCT00953407|B1|Baseline|Nelfilcon A|Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis
417506|NCT00953407|P5|Participant Flow|Hilafilcon B|Hilafilcon B contact lens
417507|NCT00953407|P4|Participant Flow|Omafilcon A|Omafilcon A contact lens
417508|NCT00953407|P3|Participant Flow|Etafilcon A|Etafilcon A contact lens
417509|NCT00953407|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
417510|NCT00953407|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
417511|NCT00953407|O5|Outcome|Hilafilcon B|Hilafilcon B contact lens
417512|NCT00953407|O4|Outcome|Omafilcon A|Omafilcon A contact lens
417513|NCT00953407|O3|Outcome|Etafilcon A|Etafilcon A contact lens
417514|NCT00953407|O2|Outcome|Narafilcon A|Narafilcon A contact lens
417515|NCT00953407|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
417516|NCT00953407|E5|Reported Event|Hilafilcon B|Hilafilcon B contact lens
417517|NCT00953407|E4|Reported Event|Omafilcon A|Omafilcon A contact lens
417518|NCT00953407|E3|Reported Event|Etafilcon A|Etafilcon A contact lens
417519|NCT00953407|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
417520|NCT00953407|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
417521|NCT00953329|B1|Baseline|Group 1|
417522|NCT00953329|P1|Participant Flow|Alefacept Treated|
417523|NCT00953329|O1|Outcome|Alefacept|50 mg
417524|NCT00953329|E1|Reported Event|Group 1|
417525|NCT00953290|B1|Baseline|Treated And Untreated Thigh|Treated and untreated arms (left and right thighs) on the same subject.
417526|NCT00953290|P1|Participant Flow|Treated and Untreated Thigh|Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject
417527|NCT00953290|O1|Outcome|Treated and Untreated Mid Thigh|Treated and untreated arms (left and right thigh) on the same subject
417528|NCT00953290|O1|Outcome|Treated Thigh|
417529|NCT00953290|O1|Outcome|Treated and Untreated Thigh|
417530|NCT00953290|O1|Outcome|Treated and Untreated Upper Thigh|Treated and untreated arms (left and right thigh) on the same participant
417531|NCT00953290|E1|Reported Event|Treated Thigh|
417532|NCT00953225|B3|Baseline|Total|Total of all reporting groups
417533|NCT00953225|B2|Baseline|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
417534|NCT00953225|B1|Baseline|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
417535|NCT00953225|P2|Participant Flow|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
417536|NCT00953225|P1|Participant Flow|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
417537|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
417538|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
417539|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
417540|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
417541|NCT00953225|E2|Reported Event|Arm 2|"Placebo daily for one year~Placebo daily for one year: Placebo"
417542|NCT00953225|E1|Reported Event|Arm 1|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
417543|NCT00953212|B5|Baseline|Total|Total of all reporting groups
417544|NCT00953212|B4|Baseline|Group D|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
417545|NCT00953212|B3|Baseline|Group C|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
417546|NCT00953212|B2|Baseline|Group B|"Beta Blockers and Ascorbic Acid~beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417547|NCT00953212|B1|Baseline|Group A|"Beta Blockers, Ascorbic Acid and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417548|NCT00953212|P4|Participant Flow|Beta Blockers Alone|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
417549|NCT00953212|P3|Participant Flow|Beta Blockers and Amiodarone|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
417550|NCT00953212|P2|Participant Flow|Beta Blockers and Ascorbic Acid|"Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417551|NCT00953212|P1|Participant Flow|Beta Blockers, Ascorbic Acid and Amiodarone|"beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417552|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417553|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417554|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417555|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417556|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417557|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417558|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417559|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417560|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417561|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417562|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417563|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417564|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417565|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417566|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417567|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417568|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417569|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417570|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417571|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417572|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417573|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417574|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417575|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417576|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417577|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417578|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417579|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417580|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417581|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417582|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417583|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417584|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417585|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417586|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417587|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417588|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417589|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417590|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417591|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417592|NCT00953212|O4|Outcome|Beta Blockers Alone|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
417593|NCT00953212|O3|Outcome|Beta Blockers and Amiodarone|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
417620|NCT00953160|P1|Participant Flow|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
418721|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
417594|NCT00953212|O2|Outcome|Beta Blockers and Ascorbic Acid|"Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417595|NCT00953212|O1|Outcome|Beta Blockers, Ascorbic Acid and Amiodarone|"beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417596|NCT00953212|O4|Outcome|Ascorbic Acid - No|Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417597|NCT00953212|O3|Outcome|Ascorbic Acid - Yes|Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
417598|NCT00953212|O2|Outcome|Amiodarone - No|Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417599|NCT00953212|O1|Outcome|Amiodarone - Yes|Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.
417600|NCT00953212|E4|Reported Event|Group D|"Beta Blockers alone~beta blockers: metoprolol 25mg by mouth every 6 hours"
417601|NCT00953212|E3|Reported Event|Group C|"Beta Blockers and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively"
417602|NCT00953212|E2|Reported Event|Group B|"Beta Blockers and Ascorbic Acid~beta blockers: metoprolol 25mg by mouth every 6 hours~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417603|NCT00953212|E1|Reported Event|Group A|"Beta Blockers, Ascorbic Acid and Amiodarone~beta blockers: metoprolol 25mg by mouth every 6 hours~amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively~ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days"
417604|NCT00953199|B3|Baseline|Total|Total of all reporting groups
417605|NCT00953199|B2|Baseline|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
417606|NCT00953199|B1|Baseline|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
417607|NCT00953199|P2|Participant Flow|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
417608|NCT00953199|P1|Participant Flow|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
417609|NCT00953199|O2|Outcome|Normal Saline|"The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.~Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care)."
417610|NCT00953199|O1|Outcome|Lidocaine|"Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2%~Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine."
417611|NCT00953199|O2|Outcome|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
417612|NCT00953199|O1|Outcome|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
417613|NCT00953199|E2|Reported Event|Normal Saline|Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
417614|NCT00953199|E1|Reported Event|Lidocaine|Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.
417615|NCT00953173|B1|Baseline|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
417616|NCT00953173|P1|Participant Flow|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
417617|NCT00953173|O1|Outcome|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
417618|NCT00953173|E1|Reported Event|LapBand|"Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System~LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption."
417619|NCT00953160|B1|Baseline|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
417622|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
417623|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
417624|NCT00953160|E1|Reported Event|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
417625|NCT00953147|B4|Baseline|Total|Total of all reporting groups
417626|NCT00953147|B3|Baseline|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417627|NCT00953147|B2|Baseline|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417628|NCT00953147|B1|Baseline|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417629|NCT00953147|P3|Participant Flow|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417630|NCT00953147|P2|Participant Flow|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417631|NCT00953147|P1|Participant Flow|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417632|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417633|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417634|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417635|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417636|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417637|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417638|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417639|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417640|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417641|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417642|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417643|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417644|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417645|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417646|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417647|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417648|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417649|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417650|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417651|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417652|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417653|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417654|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417655|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417656|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417657|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417658|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417659|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417660|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417747|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417661|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417662|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417663|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417664|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417665|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417666|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417667|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417668|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417669|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417670|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417671|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
417672|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
417673|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
417674|NCT00953147|E3|Reported Event|Placebo Once Daily|
417675|NCT00953147|E2|Reported Event|Ciclesonide HFA 160 Mcg Once Daily|
417676|NCT00953147|E1|Reported Event|Ciclesonide HFA 80 Mcg Once Daily|
417677|NCT00953121|B4|Baseline|Total|Total of all reporting groups
417678|NCT00953121|B3|Baseline|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417679|NCT00953121|B2|Baseline|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417680|NCT00953121|B1|Baseline|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417681|NCT00953121|P3|Participant Flow|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417682|NCT00953121|P2|Participant Flow|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417683|NCT00953121|P1|Participant Flow|Grade IV, No Bevacizumab Failure|"Recurrent Glioblastoma Multiforme (GBM) patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4."
417684|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417685|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
418722|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
417686|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417687|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417688|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417689|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417690|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417691|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417692|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417693|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417694|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417695|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417696|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417697|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417698|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417748|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417749|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
418723|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
417699|NCT00953121|E3|Reported Event|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417700|NCT00953121|E2|Reported Event|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417701|NCT00953121|E1|Reported Event|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
417702|NCT00953056|B7|Baseline|Total|Total of all reporting groups
417703|NCT00953056|B6|Baseline|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
417704|NCT00953056|B5|Baseline|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
417705|NCT00953056|B4|Baseline|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
417706|NCT00953056|B3|Baseline|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
417707|NCT00953056|B2|Baseline|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
417708|NCT00953056|B1|Baseline|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
417709|NCT00953056|P6|Participant Flow|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
417710|NCT00953056|P5|Participant Flow|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
417711|NCT00953056|P4|Participant Flow|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
417712|NCT00953056|P3|Participant Flow|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
417713|NCT00953056|P2|Participant Flow|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
417714|NCT00953056|P1|Participant Flow|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
417715|NCT00953056|O2|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
417716|NCT00953056|O1|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
417717|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
417718|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
417719|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
417720|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
417721|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
417722|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
417723|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
417724|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
417725|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
417726|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
417727|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
417728|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
417729|NCT00953056|E6|Reported Event|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
417730|NCT00953056|E5|Reported Event|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
417731|NCT00953056|E4|Reported Event|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
417732|NCT00953056|E3|Reported Event|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
417733|NCT00953056|E2|Reported Event|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
417734|NCT00953056|E1|Reported Event|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
417735|NCT00953043|B3|Baseline|Total|Total of all reporting groups
417736|NCT00953043|B2|Baseline|Placebo|Subjects randomized to this arm received placebo medication for three days.
417737|NCT00953043|B1|Baseline|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417738|NCT00953043|P2|Participant Flow|Placebo|Subjects randomized to this arm received placebo medication for three days.
417739|NCT00953043|P1|Participant Flow|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417740|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417741|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
418724|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
417751|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417752|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417753|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417754|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
417755|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417756|NCT00953043|E2|Reported Event|Placebo|Subjects randomized to this arm received placebo medication for three days.
417757|NCT00953043|E1|Reported Event|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
417758|NCT00953017|B5|Baseline|Total|Total of all reporting groups
417759|NCT00953017|B4|Baseline|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
417760|NCT00953017|B3|Baseline|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417761|NCT00953017|B2|Baseline|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417762|NCT00953017|B1|Baseline|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417763|NCT00953017|P4|Participant Flow|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
417764|NCT00953017|P3|Participant Flow|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417765|NCT00953017|P2|Participant Flow|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417766|NCT00953017|P1|Participant Flow|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417767|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
417768|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417769|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417770|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417771|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
417772|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417773|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417798|NCT00952822|P1|Participant Flow|Adolescents/Adults - 2 mL Then 5 mL|Adolescents/Adults - 2 mL then 5 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
418725|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
417774|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417775|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
417776|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417777|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417778|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417779|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
417780|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417781|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417782|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417783|NCT00953017|E4|Reported Event|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
417784|NCT00953017|E3|Reported Event|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417785|NCT00953017|E2|Reported Event|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417786|NCT00953017|E1|Reported Event|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
417787|NCT00952848|B1|Baseline|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
417788|NCT00952848|P1|Participant Flow|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
417789|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
417790|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
417791|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
417792|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
417793|NCT00952848|E1|Reported Event|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
417794|NCT00952822|B1|Baseline|Treated Participants|Participants who received at least 1 infusion
417795|NCT00952822|P4|Participant Flow|Pediatrics - 5 mL Then 2 mL|Pediatrics - 5 mL then 2 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
417796|NCT00952822|P3|Participant Flow|Pediatrics - 2 mL Then 5 mL|Pediatrics - 2 mL then 5 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
417797|NCT00952822|P2|Participant Flow|Adolescents/Adults - 5 mL Then 2 mL|Adolescents/Adults - 5 mL then 2 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
418726|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
417799|NCT00952822|O4|Outcome|Pediatrics at Least 5 Years of Age - 5 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=7)
417800|NCT00952822|O3|Outcome|Pediatrics at Least 5 Years of Age - 2 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI (note: 6 hours after infusion n=7)
417801|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=26)
417802|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417803|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
417804|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
417805|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417806|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417807|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417808|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417809|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417810|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417811|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417812|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417813|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417814|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417815|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417816|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417817|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
417818|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
417819|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417820|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417821|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417822|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417823|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
417824|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
417825|NCT00952822|E2|Reported Event|Pediatrics|Participants aged ≥12 to ≤65 years who received at least one infusion
417826|NCT00952822|E1|Reported Event|Adolescents/Adults|Participants aged ≥12 to ≤65 years who received at least one infusion
417827|NCT00952731|B3|Baseline|Total|Total of all reporting groups
417828|NCT00952731|B2|Baseline|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417829|NCT00952731|B1|Baseline|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417830|NCT00952731|P2|Participant Flow|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417831|NCT00952731|P1|Participant Flow|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417832|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417833|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417834|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417835|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417836|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
418727|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
417837|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417838|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417839|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417840|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417841|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417842|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417843|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417844|NCT00952731|E2|Reported Event|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
417845|NCT00952731|E1|Reported Event|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
417846|NCT00952705|B4|Baseline|Total|Total of all reporting groups
417847|NCT00952705|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417848|NCT00952705|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417849|NCT00952705|B1|Baseline|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417850|NCT00952705|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417851|NCT00952705|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417852|NCT00952705|P1|Participant Flow|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417853|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
417854|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417855|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
417856|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417857|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
417940|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
417858|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417859|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
417860|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417861|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
417862|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417863|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417864|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417865|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417866|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417867|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417868|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417869|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417870|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417871|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417872|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417873|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417874|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417875|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
418243|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
417876|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417877|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417878|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417879|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417880|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417881|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417882|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417883|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417884|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417885|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417886|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417887|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417888|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417889|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417890|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417891|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417892|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417992|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
417893|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417894|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417895|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417896|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417897|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417898|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417899|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417900|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417901|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417902|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417903|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417904|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417905|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417906|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417907|NCT00952705|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
417908|NCT00952705|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
417909|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
417993|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
418728|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
417910|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417911|NCT00952705|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
417912|NCT00952705|E1|Reported Event|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
417913|NCT00952653|B1|Baseline|DVS SR 50 mg, Midazolam 4 mg|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417914|NCT00952653|P1|Participant Flow|DVS SR 50 mg, Midazolam 4 mg|Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417915|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417916|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417917|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417918|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417919|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417920|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417921|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417922|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417923|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417924|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417925|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417926|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417927|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417928|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417929|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417930|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417931|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417932|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417933|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417934|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417935|NCT00952653|E3|Reported Event|DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)|DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
417936|NCT00952653|E2|Reported Event|DVS SR 50 mg (Period 2 / Day 1 to Day 5)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state).
417937|NCT00952653|E1|Reported Event|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
417938|NCT00952614|B1|Baseline|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
417939|NCT00952614|P1|Participant Flow|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
417994|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
417941|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide~Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years."
417942|NCT00952614|E1|Reported Event|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
417943|NCT00952588|B3|Baseline|Total|Total of all reporting groups
417944|NCT00952588|B2|Baseline|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417945|NCT00952588|B1|Baseline|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417946|NCT00952588|P2|Participant Flow|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417947|NCT00952588|P1|Participant Flow|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417948|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417949|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417950|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417951|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417952|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417953|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417954|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417955|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417956|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417957|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417958|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417959|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417960|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417961|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417962|NCT00952588|E2|Reported Event|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
417963|NCT00952588|E1|Reported Event|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
417964|NCT00952523|B1|Baseline|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
417965|NCT00952523|P1|Participant Flow|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
417966|NCT00952523|O2|Outcome|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene 0.1% and Benzoyl peroxide 2.5%
417967|NCT00952523|O1|Outcome|Tretinoin Facial Gel|Tretinoin facial gel in a 0.04% Pump
417968|NCT00952523|E2|Reported Event|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene-Benzoyl Peroxide facial gel applied once daily in a split face model
417969|NCT00952523|E1|Reported Event|Tretinoin Facial Gel|Tretinoin facial gel applied once daily in a split face model
417970|NCT00952484|B4|Baseline|Total|Total of all reporting groups
417971|NCT00952484|B3|Baseline|Historical Control|De-identified historical controls selected from a natural history database of patients with HPP.
417972|NCT00952484|B2|Baseline|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
417973|NCT00952484|B1|Baseline|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
417974|NCT00952484|P3|Participant Flow|Historical Control|"De-identified historical control patients (i.e., untreated with asfotase alfa) were selected from a longitudinal natural history database of patients with HPP maintained at Shriner’s Hospitals for Children, St. Louis, Missouri.~Historical controls must have had at least two sets of wrist and knee radiographs taken between the ages of 5 years, 0 months and 12 years, 0 months with evidence of open growth plates."
417975|NCT00952484|P2|Participant Flow|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
417976|NCT00952484|P1|Participant Flow|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
417977|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
417978|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
417979|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
417980|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
417981|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
417982|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
417983|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
417984|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
417985|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
417986|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
417987|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
417988|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
417989|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
417990|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
417991|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
418114|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
417995|NCT00952484|O2|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
417996|NCT00952484|O1|Outcome|Historical Controls|De-identified historical controls selected from a natural history database of patients with HPP.
417997|NCT00952484|E2|Reported Event|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
417998|NCT00952484|E1|Reported Event|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
417999|NCT00952419|B4|Baseline|Total|Total of all reporting groups
418000|NCT00952419|B3|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418001|NCT00952419|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418002|NCT00952419|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418003|NCT00952419|P3|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418004|NCT00952419|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418005|NCT00952419|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418006|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418007|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418008|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418009|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418010|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418011|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418012|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418013|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418014|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418015|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418016|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418017|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418018|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418019|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418020|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418021|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418022|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418023|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418024|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418025|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418026|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418027|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418028|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418029|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418030|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418031|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418032|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418033|NCT00952419|E3|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
418034|NCT00952419|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418035|NCT00952419|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
418036|NCT00952393|B1|Baseline|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
418115|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418729|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
418037|NCT00952393|P1|Participant Flow|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
418038|NCT00952393|O1|Outcome|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
418039|NCT00952393|E1|Reported Event|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
418040|NCT00952367|B1|Baseline|Per-protocol Population|In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418041|NCT00952367|P1|Participant Flow|All Enrolled Participants|Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.
418042|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418043|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418044|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418045|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418046|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418047|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418048|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418049|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418050|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418051|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418052|NCT00952367|E1|Reported Event|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
418053|NCT00952341|B3|Baseline|Total|Total of all reporting groups
418054|NCT00952341|B2|Baseline|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418055|NCT00952341|B1|Baseline|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418056|NCT00952341|P2|Participant Flow|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418057|NCT00952341|P1|Participant Flow|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418058|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418059|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418060|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418061|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418062|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418116|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418730|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
418063|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418064|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418065|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418066|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418067|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418068|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418069|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418070|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418071|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418072|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418073|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418074|NCT00952341|E2|Reported Event|Placebo, Cycle 1 & Cycle 2|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
418075|NCT00952341|E1|Reported Event|Aprepitant (MK-0869), Cycle 1 & Cycle 2|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
418076|NCT00952289|B3|Baseline|Total|Total of all reporting groups
418077|NCT00952289|B2|Baseline|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418078|NCT00952289|B1|Baseline|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418079|NCT00952289|P2|Participant Flow|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418080|NCT00952289|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count > 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
418081|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418082|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418083|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418084|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418085|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418086|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418087|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418088|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418089|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418090|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418091|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418092|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418093|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418094|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418095|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418096|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418097|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418098|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418099|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418100|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418101|NCT00952289|E2|Reported Event|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
418102|NCT00952289|E1|Reported Event|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
418103|NCT00952276|B6|Baseline|Total|Total of all reporting groups
418104|NCT00952276|B5|Baseline|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418105|NCT00952276|B4|Baseline|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418106|NCT00952276|B3|Baseline|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418107|NCT00952276|B2|Baseline|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418108|NCT00952276|B1|Baseline|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418109|NCT00952276|P5|Participant Flow|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418110|NCT00952276|P4|Participant Flow|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418111|NCT00952276|P3|Participant Flow|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418112|NCT00952276|P2|Participant Flow|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418113|NCT00952276|P1|Participant Flow|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418117|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418118|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418119|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418120|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418121|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418122|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418123|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418124|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418125|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418126|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418127|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418128|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418129|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418130|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418131|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418132|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418133|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418134|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418135|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418136|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418137|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418138|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418139|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418140|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418141|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418142|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418143|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418144|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418145|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418146|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418147|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418148|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418149|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418150|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418151|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418152|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418153|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418154|NCT00952276|E5|Reported Event|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
418155|NCT00952276|E4|Reported Event|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
418156|NCT00952276|E3|Reported Event|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
418157|NCT00952276|E2|Reported Event|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
418158|NCT00952276|E1|Reported Event|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
418159|NCT00952211|B3|Baseline|Total|Total of all reporting groups
418160|NCT00952211|B2|Baseline|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
418161|NCT00952211|B1|Baseline|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
418162|NCT00952211|P2|Participant Flow|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
418163|NCT00952211|P1|Participant Flow|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
418164|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
418165|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
418166|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
418167|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
418168|NCT00952211|E2|Reported Event|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
418169|NCT00952211|E1|Reported Event|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
418170|NCT00952133|B3|Baseline|Total|Total of all reporting groups
418171|NCT00952133|B2|Baseline|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
418172|NCT00952133|B1|Baseline|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
418173|NCT00952133|P2|Participant Flow|Palonosetron With Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
418174|NCT00952133|P1|Participant Flow|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
418175|NCT00952133|O2|Outcome|Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
418176|NCT00952133|O1|Outcome|Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
418177|NCT00952133|O2|Outcome|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
418178|NCT00952133|O1|Outcome|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
418179|NCT00952133|E2|Reported Event|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
418180|NCT00952133|E1|Reported Event|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
418181|NCT00952120|B4|Baseline|Total|Total of all reporting groups
418182|NCT00952120|B3|Baseline|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
418183|NCT00952120|B2|Baseline|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
418184|NCT00952120|B1|Baseline|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
418185|NCT00952120|P3|Participant Flow|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
418186|NCT00952120|P2|Participant Flow|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
418187|NCT00952120|P1|Participant Flow|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
418188|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
418189|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
418190|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
418191|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
418192|NCT00952120|E2|Reported Event|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
418193|NCT00952120|E1|Reported Event|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
418194|NCT00952081|B1|Baseline|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
418195|NCT00952081|P1|Participant Flow|Clevidipine,Brain Tumor,Hypertension|Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.
418196|NCT00952081|O1|Outcome|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
418197|NCT00952081|E1|Reported Event|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
418198|NCT00952068|B1|Baseline|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418199|NCT00952068|P1|Participant Flow|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418200|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418201|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418202|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418203|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418204|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418205|NCT00952068|E1|Reported Event|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
418206|NCT00951912|B4|Baseline|Total|Total of all reporting groups
418207|NCT00951912|B3|Baseline|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
418208|NCT00951912|B2|Baseline|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
418209|NCT00951912|B1|Baseline|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
418210|NCT00951912|P3|Participant Flow|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
418211|NCT00951912|P2|Participant Flow|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
418212|NCT00951912|P1|Participant Flow|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
418213|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418214|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418215|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418216|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418217|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418218|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418219|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418220|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418221|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418222|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418223|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418224|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418225|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418226|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418227|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418228|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418229|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418230|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418231|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418232|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418233|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418234|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418235|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418236|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418237|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418238|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418239|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418240|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418241|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418242|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418244|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418245|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418246|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418247|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418248|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418249|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418250|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418251|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418252|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418253|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418254|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418255|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
418256|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
418257|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
418258|NCT00951912|E3|Reported Event|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
418259|NCT00951912|E2|Reported Event|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
418260|NCT00951912|E1|Reported Event|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
418261|NCT00951899|B3|Baseline|Total|Total of all reporting groups
418262|NCT00951899|B2|Baseline|Placebo|Placebo plus diet and metformin
418263|NCT00951899|B1|Baseline|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418264|NCT00951899|P2|Participant Flow|Placebo|Placebo plus diet and metformin
418265|NCT00951899|P1|Participant Flow|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418266|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418267|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418268|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418269|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418270|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418271|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418272|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418273|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418274|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418275|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418276|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418277|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418278|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418279|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418280|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418281|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418282|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
418283|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418284|NCT00951899|E2|Reported Event|Placebo|Placebo plus diet and metformin
418285|NCT00951899|E1|Reported Event|Colesevelam|Treatment with colesevelam in addition to metformin and diet
418286|NCT00951821|B3|Baseline|Total|Total of all reporting groups
418287|NCT00951821|B2|Baseline|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
418288|NCT00951821|B1|Baseline|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
418289|NCT00951821|P2|Participant Flow|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
418290|NCT00951821|P1|Participant Flow|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
418327|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418328|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418291|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
418292|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
418293|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
418294|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
418295|NCT00951821|E2|Reported Event|Adolescent Treatment Only|"Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.~Adolescent treatment only: Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
418296|NCT00951821|E1|Reported Event|Concurrent Treatment|"Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent treatment: Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
418297|NCT00951808|B1|Baseline|All Participants|237 subjects enrolled in the feasibility study.
418298|NCT00951808|P3|Participant Flow|Standard Care Observational Cohort|Subjects who are ineligible for or who decline the blood transfusion part of the study participated in the observational portion of the study and received standard care (regular care for acute chest syndrome (ACS)).
418299|NCT00951808|P2|Participant Flow|Standard Care Trial Cohort|Subjects received standard care (regular care for acute chest syndrome (ACS)) without a clinically indicated transfusion.
418300|NCT00951808|P1|Participant Flow|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
418301|NCT00951808|O3|Outcome|Overall|Both adults and children
418302|NCT00951808|O2|Outcome|Children|Age < 18
418303|NCT00951808|O1|Outcome|Adults|Age >= 18
418304|NCT00951808|E1|Reported Event|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
418305|NCT00951665|B7|Baseline|Total|Total of all reporting groups
418306|NCT00951665|B6|Baseline|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
418307|NCT00951665|B5|Baseline|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
418308|NCT00951665|B4|Baseline|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418309|NCT00951665|B3|Baseline|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418310|NCT00951665|B2|Baseline|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418311|NCT00951665|B1|Baseline|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418312|NCT00951665|P6|Participant Flow|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
418313|NCT00951665|P5|Participant Flow|Phase IIa Group A|Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
418314|NCT00951665|P4|Participant Flow|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418315|NCT00951665|P3|Participant Flow|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418316|NCT00951665|P2|Participant Flow|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418317|NCT00951665|P1|Participant Flow|Phase Ib Regimen 1|Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously.
418318|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
418319|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418320|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418321|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418322|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418323|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418324|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
418325|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418326|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418731|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
418329|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418330|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
418331|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418332|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418333|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418334|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418335|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418336|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
418337|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418338|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418339|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418340|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418341|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418342|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
418343|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418344|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418345|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418346|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418347|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418348|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
418349|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
418350|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
418351|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
418352|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
418353|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
418354|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418355|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418356|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418357|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418358|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
418359|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418360|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418361|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418362|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418363|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
418364|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418365|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418366|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418367|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
418368|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418369|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418370|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418371|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
418372|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418373|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
418374|NCT00951665|O5|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418375|NCT00951665|O4|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418376|NCT00951665|O3|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418377|NCT00951665|O2|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
418378|NCT00951665|O1|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418379|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418380|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418381|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418382|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
418383|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
418384|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
418385|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received of T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab Q3W intravenously.
418386|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418387|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418388|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418389|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418390|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418391|NCT00951665|O2|Outcome|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab 420 mg Q3W intravenously.
418392|NCT00951665|O1|Outcome|Phase IIa Group A|Participants received MTD from Phase Ib i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418393|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418394|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418395|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418396|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418397|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418398|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418399|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418400|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418401|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418402|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418403|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418404|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418405|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
418406|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418407|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418408|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418409|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418410|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418411|NCT00951665|E6|Reported Event|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
418412|NCT00951665|E5|Reported Event|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
418413|NCT00951665|E4|Reported Event|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
418414|NCT00951665|E3|Reported Event|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
418415|NCT00951665|E2|Reported Event|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
418416|NCT00951665|E1|Reported Event|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
418417|NCT00951561|B1|Baseline|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
418418|NCT00951561|P4|Participant Flow|Ibuprofen/Vipon/Vipon/Ibuprofen|
418419|NCT00951561|P3|Participant Flow|Vipon/Ibuprofen/Ibuprofen/Vipon|
418420|NCT00951561|P2|Participant Flow|Ibuprofen/Vipon/Ibuprofen/Vipon|
418421|NCT00951561|P1|Participant Flow|Vipon/Ibuprofen/Vipon/Ibuprofen|Subjects participated for a total of 4 menstrual cycles. Subjects used either VIPON as a medical device or up to 2 ibuprofen tablets (each tablet containing 200 mg ibuprofen) during the first menstrual cycle. Subjects used crossover treatment during second menstrual cycle, randomized for cycle 3, and crossed over for cycle 4. All subjects used tampons for absorption of menstrual fluid during treatment and at least 2 hours post treatment. Subjects taking ibuprofen also used a tampon during treatment.
418422|NCT00951561|O2|Outcome|Ibuprofen|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
418423|NCT00951561|O1|Outcome|VIPON|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
418732|NCT00950911|B3|Baseline|Total|Total of all reporting groups
418424|NCT00951561|E1|Reported Event|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
418425|NCT00951509|B1|Baseline|All Subjects|"Power Mobility Road Test (PMRT): All subjects were asked to complete the real world power mobility evaluation via the PMRT.~Computer-Based Test: All subjects were asked to complete the computer-based evaluation designed to simulate real world driving in a 2D environment.~Virtual Reality Test: All subjects were asked to complete the virtual-based evaluation designed to simulate real world driving in a 3D environment."
418426|NCT00951509|P1|Participant Flow|Participants Who Qualified for the Study|All participants who qualified for the study, performed electric power wheelchair (EPW) driving under five driving conditions, while clinicians observed and assessed the EPW users' driving performance. The first four conditions were conducted in virtual environments (with different interfaces in each condition, as listed below) and condition 5 was conducted in the real world - Condition 1 - Desktop screens with no roller systems Condition 2- Desktop screens with roller systems Condition 3 - Immersive virtual reality screens with no roller systems Condition 4 - Immersive virtual reality screens with roller systems Condition 5 - Real world EPW driving
418427|NCT00951509|O5|Outcome|Condition 5|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
418428|NCT00951509|O4|Outcome|Condition 4|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
418429|NCT00951509|O3|Outcome|Condition 3|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
418430|NCT00951509|O2|Outcome|Condition 2|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
418431|NCT00951509|O1|Outcome|Condition 1|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
418432|NCT00951509|E1|Reported Event|Power Mobility Road Test|With 12 structured tasks and 4 dynamic tasks, adding to a total of 16 tasks with a minimum score of 1 and maximum of 4 in each task, it is possible to score in the range of 16 - 64 during a driving trial. To assess the driving performance, the total score for each trial was calculated and expressed as a percentage, termed “Composite score”. A Composite score of 95 % or greater would suggest that the user is a safe driver.
418433|NCT00951496|B4|Baseline|Total|Total of all reporting groups
418434|NCT00951496|B3|Baseline|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
418435|NCT00951496|B2|Baseline|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
418436|NCT00951496|B1|Baseline|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
418437|NCT00951496|P3|Participant Flow|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
418438|NCT00951496|P2|Participant Flow|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
418439|NCT00951496|P1|Participant Flow|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
418440|NCT00951496|O3|Outcome|Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)|"Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Cisplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Paclitaxel: Given IP~Quality-of-Life Assessment: Ancillary studies"
418441|NCT00951496|O2|Outcome|Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)|"Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Carboplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418442|NCT00951496|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418457|NCT00951496|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
419240|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
418443|NCT00951496|O3|Outcome|Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)|"Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Cisplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Paclitaxel: Given IP~Quality-of-Life Assessment: Ancillary studies"
418444|NCT00951496|O2|Outcome|Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)|"Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Carboplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418445|NCT00951496|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418446|NCT00951496|O3|Outcome|Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)|"Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Cisplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Paclitaxel: Given IP~Quality-of-Life Assessment: Ancillary studies"
418447|NCT00951496|O2|Outcome|Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)|"Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Carboplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418448|NCT00951496|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418449|NCT00951496|O3|Outcome|Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)|"Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Cisplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Paclitaxel: Given IP~Quality-of-Life Assessment: Ancillary studies"
418450|NCT00951496|O2|Outcome|Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)|"Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Carboplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418451|NCT00951496|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418452|NCT00951496|O3|Outcome|Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)|"Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Cisplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Paclitaxel: Given IP~Quality-of-Life Assessment: Ancillary studies"
418453|NCT00951496|O2|Outcome|Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)|"Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.~Bevacizumab: Given IV~Carboplatin: Given IP~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418454|NCT00951496|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevacizumab)|"Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies"
418455|NCT00951496|O3|Outcome|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
418456|NCT00951496|O2|Outcome|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
419241|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
418458|NCT00951496|O3|Outcome|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
418459|NCT00951496|O2|Outcome|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
418460|NCT00951496|O1|Outcome|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
418461|NCT00951496|E3|Reported Event|Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)|Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
418462|NCT00951496|E2|Reported Event|Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)|Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
418463|NCT00951496|E1|Reported Event|Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)|Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
418464|NCT00951483|B3|Baseline|Total|Total of all reporting groups
418465|NCT00951483|B2|Baseline|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
418466|NCT00951483|B1|Baseline|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418467|NCT00951483|P2|Participant Flow|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
418468|NCT00951483|P1|Participant Flow|Intervention Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418469|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418470|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418471|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418472|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418473|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418474|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418475|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418476|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418477|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418519|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418520|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418478|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418479|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418480|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418481|NCT00951483|O2|Outcome|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
418482|NCT00951483|O1|Outcome|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418483|NCT00951483|E2|Reported Event|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
418484|NCT00951483|E1|Reported Event|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
418485|NCT00951379|B3|Baseline|Total|Total of all reporting groups
418486|NCT00951379|B2|Baseline|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418487|NCT00951379|B1|Baseline|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418488|NCT00951379|P2|Participant Flow|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418489|NCT00951379|P1|Participant Flow|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418490|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418491|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418492|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418493|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418494|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
418495|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
418496|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
418497|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
418498|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
418499|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
418500|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
418501|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
418502|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
418503|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
418504|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
418505|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
418506|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
418507|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
418508|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
418509|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
418510|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
418511|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
418512|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
418513|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
418514|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418515|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418516|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418517|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418518|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418521|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418522|NCT00951379|O4|Outcome|Placebo: CRP>5 End of Study|Measure at end of Placebo treatment, approximately 24 weeks
418523|NCT00951379|O3|Outcome|Placebo: CRP> 5 Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
418524|NCT00951379|O2|Outcome|Pioglitazone: CRP>5 End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
418525|NCT00951379|O1|Outcome|Pioglitazone: CRP>5 at Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
418526|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418527|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418528|NCT00951379|E2|Reported Event|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
418529|NCT00951379|E1|Reported Event|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
418530|NCT00951275|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418531|NCT00951275|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum dose 800 mg) intravenously (IV) once every 4 weeks for a total of 6 infusions.
418532|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418533|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418534|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418535|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418536|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418537|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418538|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418539|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418540|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418541|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418542|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418543|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418544|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418545|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418546|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418547|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418548|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418549|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418550|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418551|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418552|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418553|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418554|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418555|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418556|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418557|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418558|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418559|NCT00951275|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
418560|NCT00951171|B3|Baseline|Total|Total of all reporting groups
418561|NCT00951171|B2|Baseline|Standard IUI|Insemination with TOmcat catheter
418562|NCT00951171|B1|Baseline|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
418563|NCT00951171|P2|Participant Flow|Standard IUI|Insemination with TOmcat catheter
418564|NCT00951171|P1|Participant Flow|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
418566|NCT00951171|O1|Outcome|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
418567|NCT00951171|E2|Reported Event|Standard IUI|Insemination with TOmcat catheter
418568|NCT00951171|E1|Reported Event|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
418569|NCT00951093|B1|Baseline|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery.
418570|NCT00951093|P1|Participant Flow|Patients Assessed for GERD|Patients assessed for GERD before and after Gastric Bypass Surgery
418571|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
418572|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
418573|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
418574|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
418575|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
418576|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
418577|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
418578|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
418579|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
418580|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
418581|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
418582|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
418583|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
418584|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
418585|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
418586|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
418587|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
418588|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
418589|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
418590|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
418591|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
418592|NCT00951093|E1|Reported Event|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery
418593|NCT00951015|B5|Baseline|Total|Total of all reporting groups
418594|NCT00951015|B4|Baseline|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418595|NCT00951015|B3|Baseline|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418596|NCT00951015|B2|Baseline|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418597|NCT00951015|B1|Baseline|DTG 10 mg QD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
418598|NCT00951015|P5|Participant Flow|Open-label DTG 50 mg QD|All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
418599|NCT00951015|P4|Participant Flow|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418600|NCT00951015|P3|Participant Flow|DTG 50 mg QD|Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418601|NCT00951015|P2|Participant Flow|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418602|NCT00951015|P1|Participant Flow|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
418603|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418604|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418605|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418606|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418607|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD).
418608|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
418609|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
418610|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418611|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418612|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
419242|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
418613|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418614|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
418615|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418616|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418617|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418618|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418619|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418620|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418621|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418622|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418623|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418624|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418625|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418626|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418627|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
418628|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
418629|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
418630|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
418631|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418632|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418633|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418634|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
418635|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418636|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418637|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418638|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418639|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418640|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418641|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418642|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418643|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418644|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418645|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418646|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
418647|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418648|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418649|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
419243|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
418650|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418651|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418652|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418653|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418654|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418655|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418656|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418657|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418658|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418659|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418660|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418661|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418662|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418663|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418664|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418665|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418666|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418667|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418668|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418669|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418670|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418671|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418672|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418673|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418674|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418675|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418676|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418677|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418678|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418679|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418680|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418681|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418682|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418683|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418684|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418685|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418686|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418687|NCT00951015|O4|Outcome|EFV 600 mg QD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418688|NCT00951015|O3|Outcome|DTG 50 mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418689|NCT00951015|O2|Outcome|DTG 25 mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418690|NCT00951015|O1|Outcome|DTG 10 mg QD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
418691|NCT00951015|E5|Reported Event|Open-label DTG 50 mg QD|All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
418692|NCT00951015|E4|Reported Event|EFV 600mg|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418693|NCT00951015|E3|Reported Event|DTG 50mg QD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418694|NCT00951015|E2|Reported Event|DTG 25mg QD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418695|NCT00951015|E1|Reported Event|DTG 10mg QD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
418696|NCT00950963|B3|Baseline|Total|Total of all reporting groups
418697|NCT00950963|B2|Baseline|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
418698|NCT00950963|B1|Baseline|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
418699|NCT00950963|P2|Participant Flow|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
418700|NCT00950963|P1|Participant Flow|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
418701|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
418702|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
418703|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
418704|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
418705|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
418706|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
418707|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
418708|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
418709|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
418710|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
418711|NCT00950963|E2|Reported Event|Standard Care|"Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.~Standard Clinical Care: Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses."
418712|NCT00950963|E1|Reported Event|Phone Counseling|"The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.~Phone Counseling: Patient were contacted on a periodic basis via telephone to address there diabetes care."
418713|NCT00950937|B3|Baseline|Total|Total of all reporting groups
418714|NCT00950937|B2|Baseline|Control Group|Non HIV-infected persons
418715|NCT00950937|B1|Baseline|HIV Group|HIV infected persons
418716|NCT00950937|P2|Participant Flow|Control Group|Non HIV-infected persons
418733|NCT00950911|B2|Baseline|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418734|NCT00950911|B1|Baseline|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418735|NCT00950911|P2|Participant Flow|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418736|NCT00950911|P1|Participant Flow|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418737|NCT00950911|O2|Outcome|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418738|NCT00950911|O1|Outcome|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418739|NCT00950911|E2|Reported Event|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418740|NCT00950911|E1|Reported Event|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
418741|NCT00950872|B1|Baseline|Duet TRS|"Subjects receive Duet TRS~Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS."
418742|NCT00950872|P1|Participant Flow|Duet TRS|Duet TRS is a staple line buttress
418743|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
418744|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
418745|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
418746|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
418747|NCT00950872|E1|Reported Event|Duet TRS|Duet TRS is a staple line buttress
418748|NCT00950859|B3|Baseline|Total|Total of all reporting groups
418749|NCT00950859|B2|Baseline|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418750|NCT00950859|B1|Baseline|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418751|NCT00950859|P2|Participant Flow|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418752|NCT00950859|P1|Participant Flow|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418753|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418754|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418755|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418756|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418757|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418758|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418759|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418760|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418761|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418762|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418763|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418764|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418765|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418766|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418767|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418768|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418769|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418770|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418771|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418772|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418773|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418774|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418775|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418776|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418777|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418778|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418779|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
419244|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
418780|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418781|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418782|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418783|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418784|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418785|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418786|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418787|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418788|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418789|NCT00950859|E2|Reported Event|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
418790|NCT00950859|E1|Reported Event|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
418791|NCT00950833|B4|Baseline|Total|Total of all reporting groups
418792|NCT00950833|B3|Baseline|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418793|NCT00950833|B2|Baseline|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418794|NCT00950833|B1|Baseline|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418795|NCT00950833|P3|Participant Flow|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418796|NCT00950833|P2|Participant Flow|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418797|NCT00950833|P1|Participant Flow|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418798|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418799|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418800|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418801|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418802|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418872|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418803|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418804|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418805|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418806|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418807|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418808|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418809|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418810|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418811|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418812|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418813|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418814|NCT00950833|O3|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418815|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418816|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418817|NCT00950833|O3|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418873|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418874|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
419245|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
418818|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418819|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418820|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418821|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418822|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418823|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418824|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418825|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418826|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418827|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418828|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418875|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418876|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
419246|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
418829|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418830|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418831|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418832|NCT00950833|O3|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418833|NCT00950833|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418834|NCT00950833|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418835|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418836|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418837|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418838|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418839|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418840|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418841|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418842|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418843|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418877|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418878|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
419247|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
418844|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418845|NCT00950833|O2|Outcome|Pooled Synflorix I+II Group|For the purpose of the analysis, subjects from Synflorix I Group and Synflorix II Group have been pooled into a sub-group.
418846|NCT00950833|O1|Outcome|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418847|NCT00950833|E3|Reported Event|Synflorix III Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were not previously primed with Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), but vaccinated with Nimenrix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study 2 doses of Synflorix™ vaccine at Month 9 (40-48 months of age) and at Month 11 (42-50 months of age), administered intramuscularly in the deltoid muscle.
418848|NCT00950833|E2|Reported Event|Synflorix II Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects did not receive any prophylactic antipyretic (AP) treatment.
418849|NCT00950833|E1|Reported Event|Synflorix I Group|Healthy male or female subjects between and including 31 and 44 months of age at the time of enrolment, who were previously given 3 primary vaccination doses of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107017 (NCT00370318) and one booster dose of Synflorix™ vaccine co-administered with Infanrix™ Hexa vaccine in study 107137 (NCT00496015), additionally received in the current study one dose of Synflorix™ vaccine at Month 9 (40-48 months of age), administered intramuscularly in the deltoid muscle. At the time of both primary and booster vaccinations, subjects received prophylactic antipyretic (AP) treatment with paracetamol.
418850|NCT00950807|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods, each separated by a 10-14 day washout period. Participants were randomly assigned to receive a sequence of placebo and 2 of the 9 active treatments :~UMEC 62.5, 125, 250, 500, and 1000 µg QD, UMEC 62.5, 125, and 250 µg BID, tiotropium 18 µg QD."
418851|NCT00950807|P10|Participant Flow|Tiotropium 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
418852|NCT00950807|P9|Participant Flow|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418853|NCT00950807|P8|Participant Flow|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418854|NCT00950807|P7|Participant Flow|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418855|NCT00950807|P6|Participant Flow|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418856|NCT00950807|P5|Participant Flow|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418857|NCT00950807|P4|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418858|NCT00950807|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418859|NCT00950807|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418860|NCT00950807|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
418861|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
418862|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418863|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418864|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418865|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418866|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418867|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418868|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418869|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418870|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
418871|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
418879|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418880|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
418881|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
418882|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418883|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418884|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418885|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418886|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418887|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418888|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418889|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418890|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
418891|NCT00950807|E10|Reported Event|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
418892|NCT00950807|E9|Reported Event|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418893|NCT00950807|E8|Reported Event|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418894|NCT00950807|E7|Reported Event|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
418895|NCT00950807|E6|Reported Event|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418896|NCT00950807|E5|Reported Event|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418897|NCT00950807|E4|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418898|NCT00950807|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418899|NCT00950807|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
418900|NCT00950807|E1|Reported Event|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
418901|NCT00950755|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418902|NCT00950755|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418903|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418904|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418949|NCT00950690|B1|Baseline|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
418950|NCT00950690|P1|Participant Flow|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
418951|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
418952|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
419248|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
418905|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418906|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418907|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418908|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418909|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418910|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418911|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418912|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418913|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418953|NCT00950690|E1|Reported Event|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
418954|NCT00950664|B3|Baseline|Total|Total of all reporting groups
418955|NCT00950664|B2|Baseline|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
418956|NCT00950664|B1|Baseline|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
418914|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418915|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418916|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418917|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418918|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418919|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418920|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418921|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418922|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418957|NCT00950664|P2|Participant Flow|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
418958|NCT00950664|P1|Participant Flow|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
418959|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
419249|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
418923|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418924|NCT00950755|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
418925|NCT00950742|B3|Baseline|Total|Total of all reporting groups
418926|NCT00950742|B2|Baseline|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418927|NCT00950742|B1|Baseline|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418928|NCT00950742|P2|Participant Flow|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418929|NCT00950742|P1|Participant Flow|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418930|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
418931|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
418932|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
418933|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418934|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418935|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418936|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418937|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418938|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
418939|NCT00950742|O1|Outcome|Afatinib|All patients received both Afatinib and Herceptin. Dose level 1 was continuous daily dosing with Afatinib 20mg tablets and once weekly an intravenous infusion of Herceptin. Dose level 2 was continuous daily dosing with Afatinib 30mg tablets and once weekly an intravenous infusion of Herceptin. Cycle length was 28 days.
418940|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
418941|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.
418942|NCT00950742|E2|Reported Event|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
418943|NCT00950742|E1|Reported Event|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
418944|NCT00950729|B1|Baseline|Healthy Subjects|
418945|NCT00950729|P1|Participant Flow|Healthy Subjects|
418946|NCT00950729|O1|Outcome|Healthy Subjects|
418947|NCT00950729|O1|Outcome|Healthy Subjects|
418948|NCT00950729|E1|Reported Event|Healthy Subjects|
418960|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418961|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
418962|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418963|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
418964|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418965|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
418966|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418967|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
418968|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418969|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
418970|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418971|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
418972|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418973|NCT00950664|E2|Reported Event|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
418974|NCT00950664|E1|Reported Event|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
418975|NCT00950651|B3|Baseline|Total|Total of all reporting groups
418976|NCT00950651|B2|Baseline|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418977|NCT00950651|B1|Baseline|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418978|NCT00950651|P2|Participant Flow|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418979|NCT00950651|P1|Participant Flow|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418980|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418981|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418982|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418983|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418984|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418985|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418986|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418987|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418988|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418989|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418990|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418991|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418992|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418993|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418994|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418995|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418996|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418997|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418998|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
418999|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419000|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419001|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419002|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419003|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419004|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419005|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419006|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419007|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419008|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419009|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419010|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419011|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419012|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419013|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419014|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419015|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419250|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419016|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419017|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419018|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419019|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419020|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419021|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419022|NCT00950651|E2|Reported Event|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419023|NCT00950651|E1|Reported Event|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
419024|NCT00950612|B3|Baseline|Total|Total of all reporting groups
419025|NCT00950612|B2|Baseline|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419026|NCT00950612|B1|Baseline|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419027|NCT00950612|P2|Participant Flow|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419028|NCT00950612|P1|Participant Flow|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419029|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419030|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419031|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419032|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419033|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419034|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419035|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419036|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419037|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419038|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419039|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419040|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419041|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419042|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419043|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419076|NCT00950599|P6|Participant Flow|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
419044|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419045|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419046|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419047|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419048|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419049|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419050|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419051|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419052|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419053|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419054|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419055|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419056|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419057|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419058|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419059|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419060|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419061|NCT00950612|E2|Reported Event|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
419062|NCT00950612|E1|Reported Event|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
419063|NCT00950599|B9|Baseline|Total|Total of all reporting groups
419064|NCT00950599|B8|Baseline|Placebo (0 & 100 mg Cohort)|
419065|NCT00950599|B7|Baseline|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419066|NCT00950599|B6|Baseline|Placebo (0-40 mg Cohort)|
419067|NCT00950599|B5|Baseline|Saxagliptin 40 mg (0-40 mg Cohort)|
419068|NCT00950599|B4|Baseline|Saxagliptin 20 mg (0-40 mg Cohort)|
419069|NCT00950599|B3|Baseline|Saxagliptin 10 mg (0-40 mg Cohort)|
419070|NCT00950599|B2|Baseline|Saxagliptin 5 mg (0-40 mg Cohort)|
419071|NCT00950599|B1|Baseline|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419072|NCT00950599|P10|Participant Flow|Saxa 0 & 100 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
419073|NCT00950599|P9|Participant Flow|Saxa 0-40 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
419074|NCT00950599|P8|Participant Flow|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
419075|NCT00950599|P7|Participant Flow|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
419159|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419077|NCT00950599|P5|Participant Flow|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
419078|NCT00950599|P4|Participant Flow|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
419079|NCT00950599|P3|Participant Flow|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
419080|NCT00950599|P2|Participant Flow|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
419081|NCT00950599|P1|Participant Flow|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
419082|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
419083|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419084|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419085|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419086|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419087|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419088|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419089|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419090|NCT00950599|O2|Outcome|Placebo (0 & 100 Cohort)|
419091|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419092|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419093|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419094|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419095|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419096|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419097|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419098|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419099|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419100|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419101|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419102|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419103|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419104|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419105|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419106|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
419107|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419108|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
419109|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419110|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
419111|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419112|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
419113|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419114|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
419115|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419116|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
419117|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419118|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419119|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419120|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419121|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419122|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419123|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419124|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419125|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419126|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419127|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419128|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419129|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419130|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419131|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419132|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419133|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419134|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419135|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419136|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419137|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419138|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419139|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419140|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419141|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419142|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419143|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419144|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419145|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419146|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419147|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419148|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419149|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419150|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419151|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419152|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419153|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419154|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419155|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419156|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419157|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419158|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419251|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419252|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419253|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419254|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419255|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419256|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419257|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419258|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419259|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419260|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419261|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419262|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419263|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419264|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419265|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419266|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419267|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419268|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419269|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419270|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419271|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419272|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419273|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419274|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419275|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419276|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419277|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419278|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419279|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419280|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419281|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419282|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419283|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419284|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419285|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419286|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419287|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419288|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419289|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419290|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419291|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419292|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419293|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419294|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419295|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419296|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419297|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419298|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419299|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419300|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419301|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419302|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419303|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419304|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419305|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419306|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419307|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419308|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419309|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419310|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419311|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419312|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419313|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419314|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419315|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419316|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419317|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419318|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419319|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419320|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419321|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419322|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419323|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419324|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419325|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419326|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419327|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419328|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419329|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419330|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419331|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419332|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419333|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419334|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419335|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419336|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419337|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419338|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419339|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419340|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419341|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419342|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419343|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419344|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419345|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419346|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419347|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419348|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419349|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419350|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419351|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419352|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419353|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419354|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419355|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419356|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419357|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419358|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419359|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419360|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419361|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419362|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419363|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419364|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419365|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419366|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419367|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419368|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419369|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419370|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419371|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419372|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419373|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419374|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419375|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419376|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419377|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419378|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419379|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419380|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419381|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419382|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419383|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419384|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419385|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419386|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419387|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419388|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419389|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419390|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419391|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419392|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419393|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419394|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419395|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419396|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419397|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419398|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419399|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419400|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419401|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419402|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419403|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419404|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419405|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419406|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419407|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419408|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419409|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419410|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419411|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419412|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419413|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419414|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419415|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419416|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419417|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419418|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419419|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419420|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419421|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419422|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419423|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419424|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419425|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419426|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419427|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419428|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419429|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419430|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419431|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419432|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419433|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419434|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419435|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419436|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419437|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419438|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419439|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419440|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419441|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419442|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419443|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419444|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419445|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419446|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419447|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419448|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419449|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419450|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419451|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419452|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419453|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419454|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419455|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419456|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419457|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419458|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419459|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419460|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419461|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419462|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419463|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419464|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419465|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419466|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419467|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419468|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419469|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419470|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419471|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419472|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419473|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419474|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419475|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419476|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419477|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419478|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419479|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419480|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419481|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419482|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419483|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419484|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419485|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419486|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419487|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419488|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419489|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419490|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419491|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419492|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419493|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419494|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419495|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419496|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419497|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419498|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419499|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419500|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419501|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419502|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419503|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419504|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419505|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419506|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419507|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419508|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419509|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419510|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419511|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419512|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419513|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419514|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419515|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419516|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419517|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419518|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419519|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419520|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419521|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419522|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419523|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419524|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419525|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419526|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419527|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419528|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419529|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419530|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419531|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419532|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419533|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419534|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419535|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419536|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419537|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419538|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419539|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419540|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419541|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419542|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419543|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419544|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419545|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419546|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419547|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419548|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419549|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419550|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419551|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419552|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419553|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419554|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419555|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419556|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419557|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419558|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419559|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419560|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419561|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419562|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419563|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419564|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419565|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419566|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419567|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419568|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419569|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419570|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419571|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419572|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419573|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419574|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419575|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419576|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419577|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419578|NCT00950599|O8|Outcome|Placebo (0, 100 mg Cohort)|
419579|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0, 100 mg Cohort)|
419580|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419581|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419582|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419583|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419584|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419585|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419586|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419587|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419588|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419589|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419590|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419591|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419592|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419593|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419594|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419595|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419596|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419597|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419598|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419599|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419600|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419601|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419602|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419603|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419604|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419605|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419606|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419607|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419608|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419609|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419610|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419611|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419612|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419613|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419614|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
419615|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
419616|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419617|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419618|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419619|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419620|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419621|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419622|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419623|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419624|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419625|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419626|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419627|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419628|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
419629|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
419630|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
419631|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
419632|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
419633|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
419634|NCT00950599|E8|Reported Event|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
419635|NCT00950599|E7|Reported Event|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
419636|NCT00950599|E6|Reported Event|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
419637|NCT00950599|E5|Reported Event|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
419638|NCT00950599|E4|Reported Event|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
419639|NCT00950599|E3|Reported Event|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
419640|NCT00950599|E2|Reported Event|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
419641|NCT00950599|E1|Reported Event|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
419642|NCT00950352|B3|Baseline|Total|Total of all reporting groups
419643|NCT00950352|B2|Baseline|Placebo|"32 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Placebo: Subjects were given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
419644|NCT00950352|B1|Baseline|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
419645|NCT00950352|P2|Participant Flow|Placebo|"32 subjects with methamphetamine dependence were treated with placebo for 8-9 weeks.~Placebo: Subjects were given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
419646|NCT00950352|P1|Participant Flow|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
419647|NCT00950352|O2|Outcome|Placebo|Subjects will be given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
419648|NCT00950352|O1|Outcome|Citicoline|Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
419649|NCT00950352|E2|Reported Event|Placebo|
419650|NCT00950352|E1|Reported Event|Citicoline|
419651|NCT00950300|B3|Baseline|Total|Total of all reporting groups
419652|NCT00950300|B2|Baseline|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419653|NCT00950300|B1|Baseline|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419736|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419737|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419738|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419654|NCT00950300|P2|Participant Flow|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419655|NCT00950300|P1|Participant Flow|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m^2, epirubicin 75 mg/m^2, and cyclophosphamide 500 mg/m^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.
419656|NCT00950300|O1|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419657|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419658|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419659|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419660|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419661|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419662|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419663|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419664|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419665|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419666|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419667|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419668|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419669|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419670|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419671|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419739|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419740|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419672|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419673|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419674|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419675|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419676|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419677|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419678|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419679|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419680|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419741|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419681|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419682|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419683|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419684|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419685|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419686|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419687|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419688|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419689|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419742|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419743|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419690|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419691|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419692|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419693|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419694|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419695|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419696|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419697|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419698|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419744|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419699|NCT00950300|E2|Reported Event|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419700|NCT00950300|E1|Reported Event|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
419701|NCT00950235|B3|Baseline|Total|Total of all reporting groups
419702|NCT00950235|B2|Baseline|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
419703|NCT00950235|B1|Baseline|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
419704|NCT00950235|P2|Participant Flow|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
419705|NCT00950235|P1|Participant Flow|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
419706|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
419707|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
419708|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
419709|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
419710|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
419711|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
419712|NCT00950235|E2|Reported Event|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
419713|NCT00950235|E1|Reported Event|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
419714|NCT00950183|B1|Baseline|Foot and Ankle Surgery|Our target enrollment was 82 participants. We only enrolled 36 participants. The study was terminated due to low enrollment. As a result, patients were never randomized.
419715|NCT00950183|P1|Participant Flow|Foot and Ankle Surgery|
419716|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
419717|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
419718|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
419719|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
419720|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
419721|NCT00950183|E1|Reported Event|Foot and Ankle Surgery|
419722|NCT00949975|B5|Baseline|Total|Total of all reporting groups
419723|NCT00949975|B4|Baseline|Placebo|Matched Placebo Tablets
419724|NCT00949975|B3|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419725|NCT00949975|B2|Baseline|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419726|NCT00949975|B1|Baseline|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419727|NCT00949975|P4|Participant Flow|Placebo|Matched Placebo Tablets
419728|NCT00949975|P3|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419729|NCT00949975|P2|Participant Flow|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419730|NCT00949975|P1|Participant Flow|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419731|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419732|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419733|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419734|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419735|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
420499|NCT00947531|B3|Baseline|Total|Total of all reporting groups
419745|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419746|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419747|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419748|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419749|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419750|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419751|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419752|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419753|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419754|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419755|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419756|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419757|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419758|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419759|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419760|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419761|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419762|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419763|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419764|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419765|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419766|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419767|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419768|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419769|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419770|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419771|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419772|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419773|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419774|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419775|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419776|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419777|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419778|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419779|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419780|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419781|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419782|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419783|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419784|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419785|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419786|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419787|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419788|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419789|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419790|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419791|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419792|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419793|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419794|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419795|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419796|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419797|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419798|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419799|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419800|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419801|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419802|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419803|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419804|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419805|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419806|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419807|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419808|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419809|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419810|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419811|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419812|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419813|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419814|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419815|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419816|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419817|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419818|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419819|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419820|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419821|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419822|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419823|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419824|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419825|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419826|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419827|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419828|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419829|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419830|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419831|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419832|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419833|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419834|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419835|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419836|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419837|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419838|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419839|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
419840|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419841|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419842|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419843|NCT00949975|E4|Reported Event|Placebo|Matched Placebo Tablets
419844|NCT00949975|E3|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
419845|NCT00949975|E2|Reported Event|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
419846|NCT00949975|E1|Reported Event|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
419847|NCT00949910|B1|Baseline|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419848|NCT00949910|P1|Participant Flow|Erlotinib|Erlotinib was given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). Participants were treated with 150 milligrams (mg) oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419849|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419850|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419851|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419852|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419888|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419853|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419854|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419855|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419856|NCT00949910|E1|Reported Event|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
419857|NCT00949884|B4|Baseline|Total|Total of all reporting groups
419858|NCT00949884|B3|Baseline|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419859|NCT00949884|B2|Baseline|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
419860|NCT00949884|B1|Baseline|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419861|NCT00949884|P3|Participant Flow|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419862|NCT00949884|P2|Participant Flow|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
419863|NCT00949884|P1|Participant Flow|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419864|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419865|NCT00949884|O2|Outcome|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
419866|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419867|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419868|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419869|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419870|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419871|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419872|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419873|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419874|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419875|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419876|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419877|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419878|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419879|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419880|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419881|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419882|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419883|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419884|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419885|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419886|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419887|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
420500|NCT00947531|B2|Baseline|0.9% Saline Solution|
419889|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419890|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419891|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419892|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419893|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419894|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419895|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419896|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419897|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419898|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419899|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419900|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419901|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419902|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419903|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419904|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419905|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419906|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419907|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419908|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419909|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419910|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
419911|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419912|NCT00949884|E3|Reported Event|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
419913|NCT00949884|E2|Reported Event|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
419914|NCT00949884|E1|Reported Event|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
419915|NCT00949715|B3|Baseline|Total|Total of all reporting groups
419916|NCT00949715|B2|Baseline|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419917|NCT00949715|B1|Baseline|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419918|NCT00949715|P2|Participant Flow|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419919|NCT00949715|P1|Participant Flow|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419920|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419921|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419946|NCT00949650|B1|Baseline|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419922|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419923|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419924|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419925|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419926|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419927|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
419928|NCT00949715|E1|Reported Event|No Subjects|No subjects had adverse events or death collected as part of this study.
419929|NCT00949702|B1|Baseline|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419930|NCT00949702|P1|Participant Flow|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419931|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419932|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419933|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419934|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419935|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419936|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419937|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419938|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419939|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419940|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419941|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419942|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419943|NCT00949702|E1|Reported Event|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
419944|NCT00949650|B3|Baseline|Total|Total of all reporting groups
419945|NCT00949650|B2|Baseline|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419947|NCT00949650|P2|Participant Flow|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419948|NCT00949650|P1|Participant Flow|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419949|NCT00949650|O4|Outcome|Afatinib 50 mg|Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.
419950|NCT00949650|O3|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419951|NCT00949650|O2|Outcome|Afatinib 30 mg|Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.
419952|NCT00949650|O1|Outcome|Afatinib 20 mg|Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.
419953|NCT00949650|O4|Outcome|Afatinib 50 mg|Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.
419954|NCT00949650|O3|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419955|NCT00949650|O2|Outcome|Afatinib 30 mg|Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.
419956|NCT00949650|O1|Outcome|Afatinib 20 mg|Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.
419957|NCT00949650|O4|Outcome|Afatinib 50 mg|Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.
419958|NCT00949650|O3|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419959|NCT00949650|O2|Outcome|Afatinib 30 mg|Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.
419960|NCT00949650|O1|Outcome|Afatinib 20 mg|Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.
419961|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419962|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419963|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419964|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419965|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419966|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419967|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419968|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419969|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419970|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419971|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419972|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419973|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419974|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419975|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419976|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419977|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419978|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419979|NCT00949650|O2|Outcome|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419980|NCT00949650|O1|Outcome|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419981|NCT00949650|E2|Reported Event|Pemetrexed/Cisplatin Chemotherapy|Patients received Pemetrexed 500 mg/m^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.
419982|NCT00949650|E1|Reported Event|Afatinib 40 mg|Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
419983|NCT00949533|B3|Baseline|Total|Total of all reporting groups
419984|NCT00949533|B2|Baseline|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
419985|NCT00949533|B1|Baseline|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
419986|NCT00949533|P2|Participant Flow|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
419987|NCT00949533|P1|Participant Flow|Standard Dose|Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
419988|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
419989|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
419990|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
419991|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
419992|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
419993|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
419994|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
419995|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
419996|NCT00949533|E2|Reported Event|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
419997|NCT00949533|E1|Reported Event|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
419998|NCT00949234|B1|Baseline|PEP Group|An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
419999|NCT00949234|P1|Participant Flow|PEP Group|An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
420000|NCT00949234|O1|Outcome|PEP Group|An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
420025|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420050|NCT00948896|B3|Baseline|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420001|NCT00949234|E1|Reported Event|PEP Group|An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
420002|NCT00949117|B3|Baseline|Total|Total of all reporting groups
420003|NCT00949117|B2|Baseline|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420004|NCT00949117|B1|Baseline|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420005|NCT00949117|P2|Participant Flow|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420006|NCT00949117|P1|Participant Flow|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420007|NCT00949117|O2|Outcome|Cyproheptadine HCl & PediaSure or Ensure|"Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~Ensure: Given orally~PediaSure: Given orally~cyproheptadine hydrochloride: Given orally"
420008|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~cyproheptadine hydrochloride: Given orally"
420009|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420010|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420011|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420012|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420013|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420014|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420015|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420016|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420017|NCT00949117|E2|Reported Event|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420018|NCT00949117|E1|Reported Event|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
420019|NCT00949078|B3|Baseline|Total|Total of all reporting groups
420020|NCT00949078|B2|Baseline|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420021|NCT00949078|B1|Baseline|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420022|NCT00949078|P2|Participant Flow|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420023|NCT00949078|P1|Participant Flow|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420024|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420049|NCT00948896|B4|Baseline|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420026|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420027|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420028|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420029|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420030|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420031|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420032|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420033|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420034|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420035|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420036|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420037|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420038|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420039|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420040|NCT00949078|O2|Outcome|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420041|NCT00949078|O1|Outcome|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420042|NCT00949078|E2|Reported Event|Open Label Omalizumab Group B|"Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420043|NCT00949078|E1|Reported Event|Open Label Omalizumab Group A|"Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.~omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE"
420044|NCT00948896|B9|Baseline|Total|Total of all reporting groups
420045|NCT00948896|B8|Baseline|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420046|NCT00948896|B7|Baseline|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420047|NCT00948896|B6|Baseline|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420048|NCT00948896|B5|Baseline|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
420501|NCT00947531|B1|Baseline|Cerebrolysin|
420051|NCT00948896|B2|Baseline|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420052|NCT00948896|B1|Baseline|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
420053|NCT00948896|P8|Participant Flow|HIV-exposed & DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420054|NCT00948896|P7|Participant Flow|HIV-exposed & TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420055|NCT00948896|P6|Participant Flow|HIV-exposed & SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420056|NCT00948896|P5|Participant Flow|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
420057|NCT00948896|P4|Participant Flow|HIV-unexposed & DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420058|NCT00948896|P3|Participant Flow|HIV-unexposed & TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420059|NCT00948896|P2|Participant Flow|HIV-unexposed & SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420060|NCT00948896|P1|Participant Flow|HIV-unexposed & No Chemoprevention|HIV-unexposed No chemoprevention was given
420061|NCT00948896|O4|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420062|NCT00948896|O3|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420063|NCT00948896|O2|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420064|NCT00948896|O1|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
420065|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420066|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420067|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420068|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
420069|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420070|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420071|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420072|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
420073|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420074|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420075|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420076|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
420077|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420078|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420079|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420080|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
420081|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420082|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420083|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420084|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
420085|NCT00948896|E8|Reported Event|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420086|NCT00948896|E7|Reported Event|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420087|NCT00948896|E6|Reported Event|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420088|NCT00948896|E5|Reported Event|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
420089|NCT00948896|E4|Reported Event|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
420090|NCT00948896|E3|Reported Event|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
420091|NCT00948896|E2|Reported Event|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
420092|NCT00948896|E1|Reported Event|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
420093|NCT00948857|B3|Baseline|Total|Total of all reporting groups
420094|NCT00948857|B2|Baseline|Blinded Placebo|Blinded placebo
420095|NCT00948857|B1|Baseline|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
420096|NCT00948857|P2|Participant Flow|Blinded Placebo|Blinded placebo
420097|NCT00948857|P1|Participant Flow|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
420098|NCT00948857|O2|Outcome|Placebo|Blinded placebo
420099|NCT00948857|O1|Outcome|DHEA|Dehydroepiandrosterone 25 mg tid po
420100|NCT00948857|E2|Reported Event|Blinded Placebo|Blinded placebo
420101|NCT00948857|E1|Reported Event|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
420102|NCT00948818|B3|Baseline|Total|Total of all reporting groups
420103|NCT00948818|B2|Baseline|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420104|NCT00948818|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
420105|NCT00948818|P2|Participant Flow|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420106|NCT00948818|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
420107|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420108|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420109|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420110|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420111|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420112|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420113|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420114|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420115|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420116|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420117|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420118|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420119|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420120|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420121|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420122|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420123|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420124|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420125|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420126|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420127|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420128|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420129|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420130|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420131|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420132|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420133|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
420134|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
420135|NCT00948818|E5|Reported Event|Linaclotide to Linaclotide - Randomized Withdrawal Period|Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period
420136|NCT00948818|E4|Reported Event|Linaclotide to Placebo - Randomized Withdrawal Period|"Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period."
420137|NCT00948818|E3|Reported Event|Placebo to Linaclotide - Randomized Withdrawal Period|"Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received dose-matched placebo during the 12-week randomized treatment period."
420138|NCT00948818|E2|Reported Event|Linaclotide - Treatment Period|Linaclotide 290µg, oral administration, once per day.
420139|NCT00948818|E1|Reported Event|Placebo - Treatment Period|Dose-matched placebo, oral administration, once per day.
420140|NCT00948792|B1|Baseline|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long).
420141|NCT00948792|P1|Participant Flow|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long).
420142|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
420143|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
420144|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
420145|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
420146|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
420147|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
420502|NCT00947531|P2|Participant Flow|0.9% Saline Solution|
420148|NCT00948792|E2|Reported Event|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
420149|NCT00948792|E1|Reported Event|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
420150|NCT00948766|B3|Baseline|Total|Total of all reporting groups
420151|NCT00948766|B2|Baseline|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
420152|NCT00948766|B1|Baseline|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420153|NCT00948766|P2|Participant Flow|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
420154|NCT00948766|P1|Participant Flow|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420155|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420156|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420157|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420158|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
420159|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420160|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
420161|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420162|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
420163|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420164|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
420165|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420166|NCT00948766|E3|Reported Event|Extension Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420167|NCT00948766|E2|Reported Event|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
420168|NCT00948766|E1|Reported Event|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
420169|NCT00948688|B1|Baseline|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
420170|NCT00948688|P2|Participant Flow|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
420171|NCT00948688|P1|Participant Flow|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
420172|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
420173|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
420174|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
420175|NCT00948688|O2|Outcome|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
420176|NCT00948688|O1|Outcome|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
420177|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
420228|NCT00948441|O1|Outcome|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
420178|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
420179|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
420180|NCT00948688|E2|Reported Event|Vorinostat 100mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
420181|NCT00948688|E1|Reported Event|Vorinostat 200mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)during each week of radiation therapy
420182|NCT00948675|B3|Baseline|Total|Total of all reporting groups
420183|NCT00948675|B2|Baseline|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420184|NCT00948675|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420185|NCT00948675|P2|Participant Flow|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420186|NCT00948675|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420187|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420188|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420189|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420190|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420191|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420192|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420193|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420194|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420268|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
420404|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
420195|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420196|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420197|NCT00948675|E2|Reported Event|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
420198|NCT00948675|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
420199|NCT00948610|B3|Baseline|Total|Total of all reporting groups
420200|NCT00948610|B2|Baseline|Remicade|"Remicade—Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420201|NCT00948610|B1|Baseline|Placebo|"Placebo—participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420202|NCT00948610|P2|Participant Flow|Remicade|"Remicade—Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420203|NCT00948610|P1|Participant Flow|Placebo|"Placebo—participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420204|NCT00948610|O2|Outcome|Remicade|"Remicade—Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420205|NCT00948610|O1|Outcome|Placebo|"Placebo—participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420206|NCT00948610|O2|Outcome|Remicade|"Remicade—Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420207|NCT00948610|O1|Outcome|Placebo|"Placebo—participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420208|NCT00948610|E2|Reported Event|Remicade|"Remicade—Participant will be given 10 mg/kg of drug via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420209|NCT00948610|E1|Reported Event|Placebo|"Placebo—participant will receive placebo saline solution via IV route.~Remicade: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route."
420210|NCT00948506|B3|Baseline|Total|Total of all reporting groups
420211|NCT00948506|B2|Baseline|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
420212|NCT00948506|B1|Baseline|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
420213|NCT00948506|P2|Participant Flow|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
420214|NCT00948506|P1|Participant Flow|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
420215|NCT00948506|O2|Outcome|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
420216|NCT00948506|O1|Outcome|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
420217|NCT00948506|O3|Outcome|Placebo|Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face).
420218|NCT00948506|O2|Outcome|3% Cidofovir|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
420219|NCT00948506|O1|Outcome|1% Cidofovir|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
420220|NCT00948506|E2|Reported Event|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
420221|NCT00948506|E1|Reported Event|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
420222|NCT00948441|B3|Baseline|Total|Total of all reporting groups
420223|NCT00948441|B2|Baseline|Group 2|Heparin x12 weeks; washout x4 weeks; 25% ethanol x 12 weeks
420224|NCT00948441|B1|Baseline|Group 1|25% ethanol x12 weeks; washout x4 weeks; heparin x12 weeks
420225|NCT00948441|P2|Participant Flow|Heparin Lock/Washout/25% Ethanol|First Heparin lock, then washout period, then 25% ethanol lock
420226|NCT00948441|P1|Participant Flow|25% Ethanol/Washout/Heparin|First 25% ethanol, then Washout, then heparin
420227|NCT00948441|O2|Outcome|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
420496|NCT00947544|O2|Outcome|NaPBA|NaPBA: Patients treated with NaPBA
420229|NCT00948441|O2|Outcome|Infections While Using Heparin Lock|"Heparin lock x 12 weeks~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution was instilled and allowed to dwell for 4 to 12 hours."
420230|NCT00948441|O1|Outcome|Infections While Using Ethanol Lock|"25% ethanol x 12 weeks~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
420231|NCT00948441|E2|Reported Event|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
420232|NCT00948441|E1|Reported Event|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
420233|NCT00948389|B6|Baseline|Total|Total of all reporting groups
420234|NCT00948389|B5|Baseline|Dose Level 3B|Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m²
420235|NCT00948389|B4|Baseline|Dose Level 3A|Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m²
420236|NCT00948389|B3|Baseline|Dose Level 2|Dasatinib: 100 mg BID + CCNU: 90 mg/m²
420237|NCT00948389|B2|Baseline|Dose Level 1B|Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m²
420238|NCT00948389|B1|Baseline|Dose Level 1A|Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m²
420239|NCT00948389|P5|Participant Flow|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420240|NCT00948389|P4|Participant Flow|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420241|NCT00948389|P3|Participant Flow|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420242|NCT00948389|P2|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2.
420243|NCT00948389|P1|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
420244|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420245|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420246|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420247|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
420248|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2
420249|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420250|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420251|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420252|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
420253|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
420254|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420255|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420256|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420257|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
420258|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
420259|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420260|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420261|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420262|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
420263|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
420264|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420265|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420266|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420267|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
420497|NCT00947544|O1|Outcome|HPN-100|HPN-100: Patients treated with HPN-100
420269|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420270|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420271|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420272|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
420273|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
420274|NCT00948389|E5|Reported Event|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
420275|NCT00948389|E4|Reported Event|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
420276|NCT00948389|E3|Reported Event|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
420277|NCT00948389|E2|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
420278|NCT00948389|E1|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
420279|NCT00948246|B1|Baseline|Easyband|
420280|NCT00948246|P1|Participant Flow|Easyband|
420281|NCT00948246|O1|Outcome|Easyband|
420282|NCT00948246|O1|Outcome|Easyband|
420283|NCT00948246|O1|Outcome|Easyband|
420284|NCT00948246|O1|Outcome|Easyband|
420285|NCT00948246|E1|Reported Event|Easyband|
420286|NCT00948155|B3|Baseline|Total|Total of all reporting groups
420287|NCT00948155|B2|Baseline|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420288|NCT00948155|B1|Baseline|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420289|NCT00948155|P2|Participant Flow|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420290|NCT00948155|P1|Participant Flow|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420291|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
420292|NCT00948155|O1|Outcome|Placebo|21 days using placebo
420293|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
420294|NCT00948155|O1|Outcome|Placebo|21 days using placebo
420295|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
420296|NCT00948155|O1|Outcome|Placebo|21 days using placebo
420297|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
420298|NCT00948155|O1|Outcome|Placebo|21 days using placebo
420299|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
420300|NCT00948155|O1|Outcome|Placebo|21 days using placebo
420301|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
420302|NCT00948155|O1|Outcome|Placebo|21 days using placebo
420303|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420304|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420305|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420306|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420307|NCT00948155|E2|Reported Event|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420308|NCT00948155|E1|Reported Event|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
420309|NCT00948090|B3|Baseline|Total|Total of all reporting groups
420310|NCT00948090|B2|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420311|NCT00948090|B1|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420312|NCT00948090|P4|Participant Flow|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420313|NCT00948090|P3|Participant Flow|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420314|NCT00948090|P2|Participant Flow|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420315|NCT00948090|P1|Participant Flow|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420316|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420317|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420318|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420319|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420320|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420321|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420322|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420323|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420324|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420325|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420326|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420327|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420358|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420328|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420329|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420330|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420331|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
420332|NCT00948090|E1|Reported Event|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)|The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose).
420333|NCT00948064|B4|Baseline|Total|Total of all reporting groups
420334|NCT00948064|B3|Baseline|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420335|NCT00948064|B2|Baseline|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420336|NCT00948064|B1|Baseline|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
420337|NCT00948064|P3|Participant Flow|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420338|NCT00948064|P2|Participant Flow|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420339|NCT00948064|P1|Participant Flow|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
420340|NCT00948064|O2|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420341|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420342|NCT00948064|O3|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420343|NCT00948064|O2|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420344|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
420345|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
420346|NCT00948064|E3|Reported Event|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420347|NCT00948064|E2|Reported Event|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
420348|NCT00948064|E1|Reported Event|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
420349|NCT00947882|B5|Baseline|Total|Total of all reporting groups
420350|NCT00947882|B4|Baseline|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420351|NCT00947882|B3|Baseline|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420352|NCT00947882|B2|Baseline|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420353|NCT00947882|B1|Baseline|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420354|NCT00947882|P4|Participant Flow|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420355|NCT00947882|P3|Participant Flow|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420356|NCT00947882|P2|Participant Flow|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420357|NCT00947882|P1|Participant Flow|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
420359|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420360|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420361|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
420362|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420363|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420364|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420365|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
420366|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420367|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420368|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420369|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
420370|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420371|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420372|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420373|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
420374|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420375|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420376|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
420377|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
420378|NCT00947882|E4|Reported Event|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420379|NCT00947882|E3|Reported Event|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420380|NCT00947882|E2|Reported Event|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420381|NCT00947882|E1|Reported Event|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
420382|NCT00947856|B3|Baseline|Total|Total of all reporting groups
420383|NCT00947856|B2|Baseline|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
420384|NCT00947856|B1|Baseline|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
420385|NCT00947856|P2|Participant Flow|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
420386|NCT00947856|P1|Participant Flow|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
420387|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
420388|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
420389|NCT00947856|O5|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
420390|NCT00947856|O4|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
420391|NCT00947856|O3|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
420392|NCT00947856|O2|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
420393|NCT00947856|O1|Outcome|BV Extension Total|All patients enrolled and treated on the extension arm
420394|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
420395|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
420396|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
420397|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
420398|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
420399|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
420400|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
420401|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
420402|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
420403|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
420503|NCT00947531|P1|Participant Flow|Cerebrolysin|
420405|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
420406|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
420407|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
420408|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
420409|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
420410|NCT00947856|E2|Reported Event|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
420411|NCT00947856|E1|Reported Event|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
420412|NCT00947791|B3|Baseline|Total|Total of all reporting groups
420413|NCT00947791|B2|Baseline|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420414|NCT00947791|B1|Baseline|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420415|NCT00947791|P2|Participant Flow|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420416|NCT00947791|P1|Participant Flow|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420417|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420418|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420419|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420420|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420421|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420422|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420423|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420424|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420425|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420426|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420427|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420428|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420429|NCT00947791|E2|Reported Event|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
420430|NCT00947791|E1|Reported Event|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
420431|NCT00947765|B3|Baseline|Total|Total of all reporting groups
420432|NCT00947765|B2|Baseline|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420433|NCT00947765|B1|Baseline|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420434|NCT00947765|P2|Participant Flow|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420435|NCT00947765|P1|Participant Flow|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420436|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420437|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420438|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420439|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420440|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420441|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420442|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420498|NCT00947544|E1|Reported Event|HPN-100|HPN-100: Patient treated with HPN-100
420443|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420444|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420445|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420446|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420447|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420448|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420449|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420450|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420451|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420452|NCT00947765|E2|Reported Event|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
420453|NCT00947765|E1|Reported Event|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
420454|NCT00947752|B3|Baseline|Total|Total of all reporting groups
420455|NCT00947752|B2|Baseline|F2 Glatiramer Acetate 20mg/0.5ml|
420456|NCT00947752|B1|Baseline|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
420457|NCT00947752|P2|Participant Flow|F2 Glatiramer Acetate 20mg/0.5ml|
420458|NCT00947752|P1|Participant Flow|F1 Glatiramer Acetate 20mg/1.0ml|
420459|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
420460|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
420461|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
420462|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
420463|NCT00947752|E2|Reported Event|F2 Glatiramer Acetate 20mg/0.5ml|
420464|NCT00947752|E1|Reported Event|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
420465|NCT00947661|B3|Baseline|Total|Total of all reporting groups
420466|NCT00947661|B2|Baseline|Reference0912|Reference0912 administered once daily for 12 weeks
420467|NCT00947661|B1|Baseline|SPARC0912|SPARC0912 administered once daily for 12 weeks
420468|NCT00947661|P2|Participant Flow|Reference0912|Reference0912 administered once daily for 12 weeks
420469|NCT00947661|P1|Participant Flow|SPARC0912|SPARC0912 administered once daily for 12 weeks
420470|NCT00947661|O2|Outcome|Reference0912|
420471|NCT00947661|O1|Outcome|SPARC0912|The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit).
420472|NCT00947661|E2|Reported Event|Reference0912|Reference formulation administered once daily for 12 weeks
420473|NCT00947661|E1|Reported Event|SPARC0912|SPARC's formulation administered once daily for 12 weeks
420474|NCT00947544|B1|Baseline|Participants in SO and SE|Patients who completed switch over study and enrolled safety extension study
420475|NCT00947544|P2|Participant Flow|Safety Extension Only|Participants entered the safety extension part of the study only, and received open-label HPN-100 for up to 12 months.
420476|NCT00947544|P1|Participant Flow|Swich Over and Safety Extension|NaPBA was dosed three times daily (TID) with during the first week and the same PBA mole-equivalent dose of HPN-100 during the second week. If there were safety concerns regarding a single-step transition from NaPBA to HPN-100, at the investigator's discretion, the transition could occur in 2 steps such that in the second week, subjects might receive 50% of the PBA equivalent dose as NaPBA and 50% as HPN-100 before receiving 100% of Serial blood samples were collected for PK and blood ammonia assessments after each drug reached steady state, which was achieved approximately 4 days after initiation of 100% NaPBA or HPN100 treatment. After the switch over, participants entered the safety extension part of the study and continued receiving open-label HPN-100 for up to 12 months.
420477|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100 who completed SF-15 at baseline and Month 12
420478|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420479|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420480|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420481|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420482|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420483|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420484|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420485|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420486|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420487|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420488|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420489|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420490|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420491|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420492|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
420493|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
420494|NCT00947544|O2|Outcome|Safety Extension (HPN-100)|
420495|NCT00947544|O1|Outcome|Pre-Enrollment (NaPBA)|
420504|NCT00947531|O2|Outcome|0.9% Saline Solution|
420505|NCT00947531|O1|Outcome|Cerebrolysin|
420506|NCT00947531|E2|Reported Event|0.9% Saline Solution|
420507|NCT00947531|E1|Reported Event|Cerebrolysin|
420508|NCT00947518|B4|Baseline|Total|Total of all reporting groups
420509|NCT00947518|B3|Baseline|No Skin Cleansing|No skin application
420510|NCT00947518|B2|Baseline|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
420511|NCT00947518|B1|Baseline|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
420512|NCT00947518|P3|Participant Flow|No Skin Cleansing|No skin application
420513|NCT00947518|P2|Participant Flow|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
420514|NCT00947518|P1|Participant Flow|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
420515|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
420516|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
420517|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
420518|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
420519|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
420520|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
420521|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
420522|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
420523|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
420524|NCT00947505|B3|Baseline|Total|Total of all reporting groups
420525|NCT00947505|B2|Baseline|Control Device|
420526|NCT00947505|B1|Baseline|LLT Device 2009 7 Beam|
420527|NCT00947505|P2|Participant Flow|Control Device|
420528|NCT00947505|P1|Participant Flow|LLT Device 2009 7 Beam|
420529|NCT00947505|O2|Outcome|Control Device|This is the control device emitting white light
420530|NCT00947505|O1|Outcome|LLT Device 2009 7 Beam|This is the active LLLT device
420531|NCT00947505|E2|Reported Event|Control Device|
420532|NCT00947505|E1|Reported Event|LLT Device 2009 7 Beam|
420533|NCT00947427|B3|Baseline|Total|Total of all reporting groups
420534|NCT00947427|B2|Baseline|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
420535|NCT00947427|B1|Baseline|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
420536|NCT00947427|P2|Participant Flow|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
420537|NCT00947427|P1|Participant Flow|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
420538|NCT00947427|O2|Outcome|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
420539|NCT00947427|O1|Outcome|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
420540|NCT00947427|E2|Reported Event|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
420541|NCT00947427|E1|Reported Event|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
420542|NCT00947349|B5|Baseline|Total|Total of all reporting groups
420543|NCT00947349|B4|Baseline|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420544|NCT00947349|B3|Baseline|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients
420545|NCT00947349|B2|Baseline|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420546|NCT00947349|B1|Baseline|Placebo in TN Patients|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420547|NCT00947349|P4|Participant Flow|BI 201335 NA High for Treatment Experienced (TE)|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
420548|NCT00947349|P3|Participant Flow|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420549|NCT00947349|P2|Participant Flow|BI 201335 NA Low for Treatment Naive (TN)|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
420550|NCT00947349|P1|Participant Flow|Placebo in Treatment Naive (TN) Patients|Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
420551|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420552|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420553|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420554|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420555|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420556|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420557|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
420558|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420559|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420560|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420561|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420562|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420563|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420564|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
420565|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420566|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420567|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420568|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420569|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420570|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420571|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420572|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420573|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420574|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
420575|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420576|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420577|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420578|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420579|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420580|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420581|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
420582|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420583|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420584|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420585|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420586|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420587|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420588|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
420589|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420590|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420591|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420592|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
420593|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420594|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420595|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420596|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
420597|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420598|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420599|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
420600|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
420601|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420602|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420603|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420604|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa-2a in TN patients
420605|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420606|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420607|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420608|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420609|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420610|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420611|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420612|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420613|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420614|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420615|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420616|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420617|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420618|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420619|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
420620|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
420621|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420622|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420623|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
420624|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
420625|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420626|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420627|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
420628|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
420629|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420630|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420631|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420632|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420633|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420634|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420635|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420636|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420637|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420638|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420639|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420640|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420641|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420642|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420643|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420644|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420645|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420646|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420647|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420648|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420649|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420650|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420651|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420652|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420653|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420654|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420655|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420656|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420657|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420658|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420659|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420660|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420661|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
420662|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
420663|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
420664|NCT00947349|O1|Outcome|Placebo in TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
420665|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420666|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420667|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
420668|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
420669|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420670|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
420671|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
420672|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
420673|NCT00947349|E8|Reported Event|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
420674|NCT00947349|E7|Reported Event|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
420675|NCT00947349|E6|Reported Event|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
420676|NCT00947349|E5|Reported Event|SOC TN Placebo|Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
420677|NCT00947349|E4|Reported Event|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
420678|NCT00947349|E3|Reported Event|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
420679|NCT00947349|E2|Reported Event|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
420680|NCT00947349|E1|Reported Event|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
420681|NCT00947310|B4|Baseline|Total|Total of all reporting groups
420682|NCT00947310|B3|Baseline|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
420683|NCT00947310|B2|Baseline|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
420684|NCT00947310|B1|Baseline|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
420685|NCT00947310|P3|Participant Flow|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
420686|NCT00947310|P2|Participant Flow|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
420687|NCT00947310|P1|Participant Flow|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
420688|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
420689|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
420690|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
420691|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
420692|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
420693|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
420694|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
420695|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
420696|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
420697|NCT00947310|E3|Reported Event|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
420698|NCT00947310|E2|Reported Event|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
420699|NCT00947310|E1|Reported Event|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
420700|NCT00947297|B1|Baseline|HPN-100|Patients who were treated with HPN-100
420701|NCT00947297|P1|Participant Flow|HPN-100|Patients who were treated with HPN-100
420702|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100~HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
420703|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100~HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
420704|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
420705|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
420706|NCT00947297|E1|Reported Event|HPN-100|Patients who were treated with HPN-100
420707|NCT00947284|B1|Baseline|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
420708|NCT00947284|P2|Participant Flow|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
420709|NCT00947284|P1|Participant Flow|Women-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
420710|NCT00947284|O1|Outcome|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
420711|NCT00947284|E1|Reported Event|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
420712|NCT00947271|B5|Baseline|Total|Total of all reporting groups
420713|NCT00947271|B4|Baseline|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420714|NCT00947271|B3|Baseline|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420715|NCT00947271|B2|Baseline|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420716|NCT00947271|B1|Baseline|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420717|NCT00947271|P4|Participant Flow|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420718|NCT00947271|P3|Participant Flow|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420719|NCT00947271|P2|Participant Flow|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420720|NCT00947271|P1|Participant Flow|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420721|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420722|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420723|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420724|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420725|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420726|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420727|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420728|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420729|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420730|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420731|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420732|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420733|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420734|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420735|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420901|NCT00946881|O1|Outcome|2 mg/Kg-200 J/cm|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 2 mg/kg-200J/cm
420736|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420737|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420738|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420739|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420740|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420741|NCT00947271|E4|Reported Event|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420742|NCT00947271|E3|Reported Event|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
420743|NCT00947271|E2|Reported Event|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420744|NCT00947271|E1|Reported Event|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
420745|NCT00947219|B4|Baseline|Total|Total of all reporting groups
420746|NCT00947219|B3|Baseline|Control Device|Control device emitting LED light
420747|NCT00947219|B2|Baseline|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
420748|NCT00947219|B1|Baseline|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
420749|NCT00947219|P3|Participant Flow|Control Device|Control device emitting LED light
420750|NCT00947219|P2|Participant Flow|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
420751|NCT00947219|P1|Participant Flow|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
420752|NCT00947219|O3|Outcome|Control Device|Control device emitting white light
420753|NCT00947219|O2|Outcome|HairMax LaserComb 2009 9 Beam|the active LLLT Device 2009 9 laser modules
420754|NCT00947219|O1|Outcome|HairMax LaserComb 2009, 12 Beam|The active LLLT Device 2009 with 12 laser modules
420755|NCT00947219|E3|Reported Event|Control Device|Control device emitting LED light
420756|NCT00947219|E2|Reported Event|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
420757|NCT00947219|E1|Reported Event|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
420758|NCT00947167|B1|Baseline|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
420759|NCT00947167|P1|Participant Flow|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
420760|NCT00947167|O1|Outcome|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
420761|NCT00947167|O1|Outcome|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
420762|NCT00947167|E1|Reported Event|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
420763|NCT00947154|B1|Baseline|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
420764|NCT00947154|P1|Participant Flow|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
420765|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
420788|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420902|NCT00946881|O2|Outcome|4 mg/kg|Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
420766|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
420767|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
420768|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
420769|NCT00947154|E1|Reported Event|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
420770|NCT00947115|B4|Baseline|Total|Total of all reporting groups
420771|NCT00947115|B3|Baseline|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420772|NCT00947115|B2|Baseline|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420773|NCT00947115|B1|Baseline|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420774|NCT00947115|P3|Participant Flow|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420775|NCT00947115|P2|Participant Flow|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420776|NCT00947115|P1|Participant Flow|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420777|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420778|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420779|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420780|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420781|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420782|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420783|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420784|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420785|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420786|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420787|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420844|NCT00947011|E1|Reported Event|Januvia|Januvia: 1 tablet 100 mg once a day
420845|NCT00946998|B3|Baseline|Total|Total of all reporting groups
420789|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420790|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420791|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420792|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420793|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420794|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420795|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420796|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420797|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420798|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420799|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420800|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420801|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420802|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420803|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420804|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420805|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420806|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420807|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420808|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420809|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420810|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420811|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420812|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420813|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420846|NCT00946998|B2|Baseline|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420814|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420815|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420816|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420817|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420818|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420819|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420820|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420821|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420822|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420823|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420824|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420825|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420826|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420827|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420828|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420829|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420830|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420831|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420832|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420833|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420834|NCT00947115|E3|Reported Event|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420835|NCT00947115|E2|Reported Event|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420836|NCT00947115|E1|Reported Event|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
420837|NCT00947011|B1|Baseline|All Particpants|"Januvia: 1 tablet 100 mg once a day~OR~Placebo: 1 tablet 100 mg once a day"
420838|NCT00947011|P1|Participant Flow|All Participants|"Januvia: 1 tablet 100 mg once a day~OR~Placebo comparator"
420839|NCT00947011|O2|Outcome|Placebo|Placebo: 1 tablet 100 mg once a day
420840|NCT00947011|O1|Outcome|Januvia|Januvia: 1 tablet 100 mg once a day
420841|NCT00947011|O2|Outcome|Placebo|Placebo: 1 tablet 100 mg once a day
420842|NCT00947011|O1|Outcome|Januvia|Januvia: 1 tablet 100 mg once a day
420843|NCT00947011|E2|Reported Event|Placebo|Placebo: 1 tablet 100 mg once a day
420847|NCT00946998|B1|Baseline|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420848|NCT00946998|P2|Participant Flow|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420849|NCT00946998|P1|Participant Flow|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420850|NCT00946998|O2|Outcome|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420851|NCT00946998|O1|Outcome|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420852|NCT00946998|O2|Outcome|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420853|NCT00946998|O1|Outcome|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420854|NCT00946998|O2|Outcome|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420855|NCT00946998|O1|Outcome|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420856|NCT00946998|O2|Outcome|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420857|NCT00946998|O1|Outcome|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420858|NCT00946998|O2|Outcome|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420859|NCT00946998|O1|Outcome|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420860|NCT00946998|E2|Reported Event|Placebo|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet."
420861|NCT00946998|E1|Reported Event|Sertraline|"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"
420862|NCT00946985|B1|Baseline|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
420863|NCT00946985|P1|Participant Flow|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
420864|NCT00946985|O1|Outcome|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
420865|NCT00946985|E1|Reported Event|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
420866|NCT00946920|B3|Baseline|Total|Total of all reporting groups
420867|NCT00946920|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420868|NCT00946920|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420869|NCT00946920|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420870|NCT00946920|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420871|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420872|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420900|NCT00946881|O2|Outcome|2 mg/Kg-300 J/cm|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 2 mg/kg-300J/cm
420873|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420874|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420875|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420876|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420877|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420878|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420879|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420880|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420881|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420882|NCT00946920|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
420883|NCT00946920|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
420884|NCT00946881|B1|Baseline|WST 11(TOOKAD® Soluble)|"WST 11-mediated-VTP~WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance."
420885|NCT00946881|P1|Participant Flow|WST 11(TOOKAD® Soluble)|"WST 11-mediated-VTP~WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance."
420886|NCT00946881|O2|Outcome|4 mg/kg|Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
420887|NCT00946881|O1|Outcome|2 mg/kg|Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
420888|NCT00946881|O2|Outcome|4 mg/kg|Patients treated at the dose of 4 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
420889|NCT00946881|O1|Outcome|2 mg/kg|Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
420890|NCT00946881|O4|Outcome|All Doses/Energies|To assess the QoL-IPSS in patients treated with all doses/energies
420891|NCT00946881|O3|Outcome|4 mg/Kg-200 J/cm|To assess the QoL-IPSS in patients treated with the dose 4mg/Kg-200J/cm
420892|NCT00946881|O2|Outcome|2 mg/Kg-300 J/cm|To assess the QoL-IPSS in patients treated with the dose 2mg/Kg-300J/cm
420893|NCT00946881|O1|Outcome|2 mg/Kg-200 J/cm|To assess the QoL-IPSS in patients treated with the dose 2mg/Kg-200J/cm
420894|NCT00946881|O4|Outcome|All Doses/Energies|To assess the QoL-IIEF in patients treated with all doses/energies
420895|NCT00946881|O3|Outcome|4 mg/Kg-200 J/cm|To assess the QoL-IIEF in patients treated with the dose 4mg/Kg-200J/cm
420896|NCT00946881|O2|Outcome|2 mg/Kg-300 J/cm|To assess the QoL-IIEF in patients treated with the dose 2mg/Kg-300J/cm
420897|NCT00946881|O1|Outcome|2 mg/Kg-200 J/cm|To assess the QoL-IIEF in patients treated with the dose 2mg/Kg-200J/cm
420898|NCT00946881|O4|Outcome|All Doses/Energies|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with all doses/energies
420899|NCT00946881|O3|Outcome|4 mg/Kg-200 J/cm|To evaluate the volume of necrosis observed on the 7-Day MRI in patients treated with 4 mg/kg-200J/cm
420903|NCT00946881|O1|Outcome|2 mg/kg|Patients treated at the dose of 2 mg/kg of TOOKAD soluble, regardless of the dose of light, are analysed in this group.
420904|NCT00946881|O4|Outcome|All Doses/Energies|Number of patients with negative biopsies at all doses/energies
420905|NCT00946881|O3|Outcome|4 mg/Kg-200 J/cm|Number of patients with negative biopsies at the dose 4mg/Kg-200J/cm
420906|NCT00946881|O2|Outcome|2 mg/Kg-300 J/cm|Number of patients with negative biopsies at the dose 2mg/Kg-300J/cm
420907|NCT00946881|O1|Outcome|2 mg/Kg-200 J/cm|Number of patients with negative biopsies at the dose 2mg/Kg-200J/cm
420908|NCT00946881|O4|Outcome|All Doses/Energies|Number of patients with positives or négatives biopsies at all doses/energies
420909|NCT00946881|O3|Outcome|4 mg/Kg-200 J/cm|Number of patients with positives or négatives biopsies at the dose 4mg/Kg-200J/cm
420910|NCT00946881|O2|Outcome|2 mg/Kg-300 J/cm|Number of patients with positives or négatives biopsies at the dose 2mg/Kg-300J/cm
420911|NCT00946881|O1|Outcome|2 mg/Kg-200 J/cm|Number of patients with positives or négatives biopsies at the dose 2mg/Kg-200J/cm
420912|NCT00946881|E1|Reported Event|WST 11(TOOKAD® Soluble)|"WST 11-mediated-VTP The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers using 753 nm laser light at escalating fixed energy doses~WST 11 -mediated -VTP: The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance."
420913|NCT00946530|B5|Baseline|Total|Total of all reporting groups
420914|NCT00946530|B4|Baseline|Dim Light (Control) - Caregivers|Caregivers received dim light
420915|NCT00946530|B3|Baseline|Bright Light - Caregivers|Caregivers received bright light
420916|NCT00946530|B2|Baseline|Dim Light (Control) - AD Patients|AD patients received dim light
420917|NCT00946530|B1|Baseline|Bright Light-AD Patients|AD patients received bright light
420918|NCT00946530|P4|Participant Flow|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
420919|NCT00946530|P3|Participant Flow|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
420920|NCT00946530|P2|Participant Flow|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
420921|NCT00946530|P1|Participant Flow|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
420922|NCT00946530|O4|Outcome|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
420923|NCT00946530|O3|Outcome|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
420924|NCT00946530|O2|Outcome|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
420925|NCT00946530|O1|Outcome|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
420926|NCT00946530|O4|Outcome|Dim Light (Control) - Caregiver|Caregiver received regular (dim) Light
420927|NCT00946530|O3|Outcome|Bright Light - Caregiver|Caregiver received Bright Light
420928|NCT00946530|O2|Outcome|Dim Light (Control) - AD Patients|AD patient received regular (dim) light
420929|NCT00946530|O1|Outcome|Bright Light - AD Patient|AD patient received bright light
420930|NCT00946530|E4|Reported Event|Dim Light (Control) - Caregivers|Caregivers received dim light
420931|NCT00946530|E3|Reported Event|Bright Light - Caregivers|Caregivers received bright light
420932|NCT00946530|E2|Reported Event|Dim Light (Control) - AD Patients|AD patients received dim light
420933|NCT00946530|E1|Reported Event|Bright Light-AD Patients|AD patients received bright light
420934|NCT00946478|B3|Baseline|Total|Total of all reporting groups
420935|NCT00946478|B2|Baseline|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420936|NCT00946478|B1|Baseline|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420937|NCT00946478|P2|Participant Flow|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420967|NCT00946309|P1|Participant Flow|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420968|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
420938|NCT00946478|P1|Participant Flow|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420939|NCT00946478|O2|Outcome|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420940|NCT00946478|O1|Outcome|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420941|NCT00946478|E2|Reported Event|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420942|NCT00946478|E1|Reported Event|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
420943|NCT00946348|B3|Baseline|Total|Total of all reporting groups
420944|NCT00946348|B2|Baseline|Cannabis|Cannabis cigarette (3.6% THC)
420945|NCT00946348|B1|Baseline|Dronabinol|Dronabinol 15 mg
420946|NCT00946348|P2|Participant Flow|Cannabis|Cannabis cigarette (3.6% THC)
420947|NCT00946348|P1|Participant Flow|Dronabinol|Dronabinol 15 mg
420948|NCT00946348|O2|Outcome|Cannabis|Cannabis cigarette (3.6% THC)
420949|NCT00946348|O1|Outcome|Dronabinol|Dronabinol 15 mg
420950|NCT00946348|E2|Reported Event|Cannabis|Cannabis cigarette (3.6% THC)
420951|NCT00946348|E1|Reported Event|Dronabinol|Dronabinol 15 mg
420952|NCT00946322|B1|Baseline|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420953|NCT00946322|P1|Participant Flow|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420954|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420955|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420956|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420957|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420958|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420959|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420960|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420961|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420962|NCT00946322|E1|Reported Event|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
420963|NCT00946309|B3|Baseline|Total|Total of all reporting groups
420964|NCT00946309|B2|Baseline|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
420965|NCT00946309|B1|Baseline|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420966|NCT00946309|P2|Participant Flow|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
420969|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420970|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
420971|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420972|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
420973|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420974|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
420975|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420976|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
420977|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420978|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
420979|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420980|NCT00946309|E2|Reported Event|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
420981|NCT00946309|E1|Reported Event|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
420982|NCT00946296|B3|Baseline|Total|Total of all reporting groups
420983|NCT00946296|B2|Baseline|No Treatment|The experimental group receives no treatment.
420984|NCT00946296|B1|Baseline|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
420985|NCT00946296|P2|Participant Flow|No Treatment|The experimental group receives no treatment.
420986|NCT00946296|P1|Participant Flow|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
420987|NCT00946296|O2|Outcome|No Treatment|The experimental group receives no treatment.
420988|NCT00946296|O1|Outcome|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
420989|NCT00946296|E2|Reported Event|No Treatment|The experimental group receives no treatment.
420990|NCT00946296|E1|Reported Event|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
420991|NCT00946114|B3|Baseline|Total|Total of all reporting groups
420992|NCT00946114|B2|Baseline|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
420993|NCT00946114|B1|Baseline|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
420994|NCT00946114|P2|Participant Flow|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
420995|NCT00946114|P1|Participant Flow|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
420996|NCT00946114|O2|Outcome|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
420997|NCT00946114|O1|Outcome|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
420998|NCT00946114|E2|Reported Event|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
420999|NCT00946114|E1|Reported Event|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
421000|NCT00946101|B3|Baseline|Total|Total of all reporting groups
421001|NCT00946101|B2|Baseline|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421002|NCT00946101|B1|Baseline|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421003|NCT00946101|P2|Participant Flow|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421004|NCT00946101|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421005|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421006|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421007|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421008|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421009|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421010|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421011|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421012|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421013|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421014|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421015|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421016|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421017|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421018|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421019|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421020|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421021|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421022|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421023|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421024|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421025|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421026|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421027|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421028|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421029|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421030|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421031|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421032|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421033|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421034|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421035|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421036|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421037|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421038|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421039|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421040|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421041|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421042|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421043|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421044|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421045|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421046|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421047|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421048|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421049|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421083|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421084|NCT00946088|O2|Outcome|Polyethylene & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421050|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421051|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421052|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421053|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421054|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421055|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421056|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421057|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421058|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421059|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421060|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421061|NCT00946101|E6|Reported Event|Placebo Days 58-209|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
421062|NCT00946101|E5|Reported Event|H1N1 Monovalent Vaccine Days 58-209|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
421063|NCT00946101|E4|Reported Event|Placebo Days 29-57|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
421064|NCT00946101|E3|Reported Event|H1N1 Monvalent Vaccine Days 29-57|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
421065|NCT00946101|E2|Reported Event|Placebo Days 1-28|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
421066|NCT00946101|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-28|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
421067|NCT00946088|B3|Baseline|Total|Total of all reporting groups
421068|NCT00946088|B2|Baseline|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
421069|NCT00946088|B1|Baseline|Progesterone|Progesterone 400 mg per vagina qhs.
421070|NCT00946088|P2|Participant Flow|Polyethylene Glycol 400 Distearate & Hydrogenated Vegetable oi|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
421071|NCT00946088|P1|Participant Flow|Progesterone|Progesterone 400 mg per vagina qhs.
421072|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421073|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421074|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421075|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421076|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421077|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421078|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421079|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421080|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421081|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421082|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421085|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421086|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421087|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421088|NCT00946088|O2|Outcome|Polyethylene Glycol&Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
421089|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
421090|NCT00946088|E2|Reported Event|Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab|Placebo Comparator:Polyethylene glycol&hydrogenated vegetable oil per vagina.
421091|NCT00946088|E1|Reported Event|Active Comparator: Progesterone|Progesterone 400mg per vagina qhs.
421092|NCT00945958|B1|Baseline|SPARC0913|Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler.
421093|NCT00945958|P1|Participant Flow|SPARC0913|
421094|NCT00945958|O1|Outcome|SPARC0913|SPARC0913: One drop of SPARC0913 in affected eye once daily for 24 weeks
421095|NCT00945958|O1|Outcome|SPARC|The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms.
421096|NCT00945958|E1|Reported Event|SPARC0913|From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated
421097|NCT00945945|B3|Baseline|Total|Total of all reporting groups
421098|NCT00945945|B2|Baseline|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421099|NCT00945945|B1|Baseline|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421100|NCT00945945|P2|Participant Flow|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421101|NCT00945945|P1|Participant Flow|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421102|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421103|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421104|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421145|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421389|NCT00945100|O1|Outcome|Control|2 hours daily patching
421105|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421106|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421107|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421108|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421109|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421110|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421111|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421112|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421113|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421235|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
421236|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
421237|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
421114|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421115|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421116|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421117|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421118|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421119|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421120|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421121|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421122|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421144|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421123|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421124|NCT00945945|E2|Reported Event|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
421125|NCT00945945|E1|Reported Event|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
421126|NCT00945906|B1|Baseline|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421127|NCT00945906|P1|Participant Flow|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421128|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421129|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421130|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421131|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421132|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421133|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421134|NCT00945906|E1|Reported Event|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
421135|NCT00945893|B3|Baseline|Total|Total of all reporting groups
421136|NCT00945893|B2|Baseline|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421137|NCT00945893|B1|Baseline|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421138|NCT00945893|P2|Participant Flow|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421139|NCT00945893|P1|Participant Flow|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
421140|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421141|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421142|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421143|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421238|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
421146|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421147|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421148|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421149|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421150|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421151|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421152|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421153|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421154|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421155|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421156|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421157|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421158|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421159|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421160|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421161|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421162|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421163|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421164|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421165|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421239|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
421240|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
421241|NCT00945750|E3|Reported Event|Famotidine 20 mg CT With Water|Famotidine 20 mg chewable tablet with 120 mL of water
421166|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421167|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421168|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421169|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421170|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421171|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421172|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421173|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421174|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421175|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421176|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421177|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421178|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421179|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421180|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421181|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421182|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421183|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421184|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421185|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421242|NCT00945750|E2|Reported Event|Famotidine 20 mg CT Without Water|Famotidine 20 mg Chewable Tablet without water
421243|NCT00945750|E1|Reported Event|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water
421186|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421187|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421188|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421189|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421190|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421191|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421192|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421193|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421194|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
421195|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421196|NCT00945893|E6|Reported Event|Placebo Days 58-209|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421197|NCT00945893|E5|Reported Event|H1N1 Monovalent Days 58-209|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421198|NCT00945893|E4|Reported Event|Placebo Days 29-57|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421199|NCT00945893|E3|Reported Event|H1N1 Monovalent Vaccine Days 29-57|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421200|NCT00945893|E2|Reported Event|Placebo Days 1-15|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421201|NCT00945893|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-15|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
421202|NCT00945854|B3|Baseline|Total|Total of all reporting groups
421203|NCT00945854|B2|Baseline|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421204|NCT00945854|B1|Baseline|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421244|NCT00945555|B1|Baseline|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421245|NCT00945555|P1|Participant Flow|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421205|NCT00945854|P2|Participant Flow|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421206|NCT00945854|P1|Participant Flow|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421207|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421208|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421209|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421210|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421211|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421212|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421213|NCT00945854|E2|Reported Event|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421246|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421247|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421248|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421214|NCT00945854|E1|Reported Event|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
421215|NCT00945815|B1|Baseline|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
421216|NCT00945815|P1|Participant Flow|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
421217|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
421218|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
421219|NCT00945815|E1|Reported Event|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
421220|NCT00945750|B7|Baseline|Total|Total of all reporting groups
421221|NCT00945750|B6|Baseline|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
421222|NCT00945750|B5|Baseline|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
421223|NCT00945750|B4|Baseline|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
421224|NCT00945750|B3|Baseline|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
421225|NCT00945750|B2|Baseline|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
421226|NCT00945750|B1|Baseline|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
421227|NCT00945750|P6|Participant Flow|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
421228|NCT00945750|P5|Participant Flow|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
421229|NCT00945750|P4|Participant Flow|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
421230|NCT00945750|P3|Participant Flow|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
421231|NCT00945750|P2|Participant Flow|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
421232|NCT00945750|P1|Participant Flow|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
421233|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
421234|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
421249|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421250|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421251|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421252|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421253|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421254|NCT00945555|E1|Reported Event|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
421255|NCT00945477|B1|Baseline|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
421256|NCT00945477|P1|Participant Flow|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
421257|NCT00945477|O1|Outcome|Participants With Adverse Events 800mg Pazopanib|Adverse events for all participants, all grades
421258|NCT00945477|O1|Outcome|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
421259|NCT00945477|E1|Reported Event|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
421260|NCT00945334|B3|Baseline|Total|Total of all reporting groups
421261|NCT00945334|B2|Baseline|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
421262|NCT00945334|B1|Baseline|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
421263|NCT00945334|P2|Participant Flow|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
421264|NCT00945334|P1|Participant Flow|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
421265|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
421266|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
421267|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
421268|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
421269|NCT00945334|E2|Reported Event|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
421270|NCT00945334|E1|Reported Event|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
421271|NCT00945321|B1|Baseline|All Participants|All randomized patients.
421272|NCT00945321|P6|Participant Flow|C/B/A/E|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
421273|NCT00945321|P5|Participant Flow|B/A/C/E|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
421274|NCT00945321|P4|Participant Flow|A/C/B/E|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
421275|NCT00945321|P3|Participant Flow|C/A/B/D|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
421276|NCT00945321|P2|Participant Flow|B/C/A/D|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
421277|NCT00945321|P1|Participant Flow|A/B/C/D|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
421278|NCT00945321|O6|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
421387|NCT00945100|O1|Outcome|Control|2 hours daily patching
421534|NCT00944554|O2|Outcome|Varenicline|Experimental group given varenicline twice a day or five weeks.
421279|NCT00945321|O5|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
421280|NCT00945321|O4|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
421281|NCT00945321|O3|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
421282|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
421283|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
421284|NCT00945321|O7|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
421285|NCT00945321|O6|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
421286|NCT00945321|O5|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
421287|NCT00945321|O4|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
421288|NCT00945321|O3|Outcome|150 mg Fosaprepitant Dimeglumine (Fasted State)|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
421289|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
421290|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
421291|NCT00945321|E5|Reported Event|185 mg Aprepitant (Fed State)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
421292|NCT00945321|E4|Reported Event|165 mg Aprepitant (Fed State)|"165 mg aprepitant Final Market Composition capsule in the fed~state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the~subjects (9) in this treatment group received a standard light breakfast)"
421293|NCT00945321|E3|Reported Event|150 mg Fosaprepitant Dimeglumine|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
421294|NCT00945321|E2|Reported Event|185 mg Aprepitant|185 mg aprepitant Final Market Composition capsule in the fasted state
421295|NCT00945321|E1|Reported Event|165 mg Aprepitant|165 mg aprepitant Final Market Composition capsule in the fasted state
421296|NCT00945295|B3|Baseline|Total|Total of all reporting groups
421297|NCT00945295|B2|Baseline|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421298|NCT00945295|B1|Baseline|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421299|NCT00945295|P2|Participant Flow|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421300|NCT00945295|P1|Participant Flow|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421301|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421302|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421303|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421304|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421388|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421305|NCT00945295|E2|Reported Event|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421306|NCT00945295|E1|Reported Event|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
421307|NCT00945256|B6|Baseline|Total|Total of all reporting groups
421308|NCT00945256|B5|Baseline|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
421309|NCT00945256|B4|Baseline|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421310|NCT00945256|B3|Baseline|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421311|NCT00945256|B2|Baseline|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
421312|NCT00945256|B1|Baseline|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
421313|NCT00945256|P5|Participant Flow|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
421314|NCT00945256|P4|Participant Flow|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421315|NCT00945256|P3|Participant Flow|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421316|NCT00945256|P2|Participant Flow|Elderly Aerobic Exercise|45 minutes of treadmill walking at 40% VO2 peak.
421317|NCT00945256|P1|Participant Flow|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak
421318|NCT00945256|O5|Outcome|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and a 7.5g amino acid drink taken orally.
421319|NCT00945256|O4|Outcome|Elderly Sodium Nitroprusside (SNP)|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421320|NCT00945256|O3|Outcome|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421321|NCT00945256|O2|Outcome|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
421322|NCT00945256|O1|Outcome|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
421323|NCT00945256|E5|Reported Event|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally.
421324|NCT00945256|E4|Reported Event|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421325|NCT00945256|E3|Reported Event|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
421326|NCT00945256|E2|Reported Event|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
421327|NCT00945256|E1|Reported Event|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
421328|NCT00945243|B1|Baseline|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
421329|NCT00945243|P1|Participant Flow|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
421330|NCT00945243|O1|Outcome|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
421331|NCT00945243|O1|Outcome|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
421332|NCT00945243|O1|Outcome|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
421333|NCT00945243|E1|Reported Event|Treatment|Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
421334|NCT00945139|B1|Baseline|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
421335|NCT00945139|P1|Participant Flow|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
421336|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
421337|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
421338|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
421339|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
421340|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
421341|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
421342|NCT00945139|E1|Reported Event|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
421343|NCT00945100|B3|Baseline|Total|Total of all reporting groups
421344|NCT00945100|B2|Baseline|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421345|NCT00945100|B1|Baseline|Control|2 hours daily patching
421346|NCT00945100|P2|Participant Flow|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421347|NCT00945100|P1|Participant Flow|Control|2 hours daily patching
421348|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421349|NCT00945100|O1|Outcome|Control|2 hours daily patching
421350|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421351|NCT00945100|O1|Outcome|Control|2 hours daily patching
421352|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421353|NCT00945100|O1|Outcome|Control|2 hours daily patching
421354|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421355|NCT00945100|O1|Outcome|Control|2 hours daily patching
421356|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421357|NCT00945100|O1|Outcome|Control|2 hours daily patching
421358|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421359|NCT00945100|O1|Outcome|Control|2 hours daily patching
421360|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421361|NCT00945100|O1|Outcome|Control|2 hours daily patching
421362|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421363|NCT00945100|O1|Outcome|Control|2 hours daily patching
421364|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421365|NCT00945100|O1|Outcome|Control|2 hours daily patching
421366|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421367|NCT00945100|O1|Outcome|Control|2 hours daily patching
421368|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421369|NCT00945100|O1|Outcome|Control|2 hours daily patching
421370|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421371|NCT00945100|O1|Outcome|Control|2 hours daily patching
421372|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421373|NCT00945100|O1|Outcome|Control|2 hours daily patching
421374|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421375|NCT00945100|O1|Outcome|Control|2 hours daily patching
421376|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421377|NCT00945100|O1|Outcome|Control|2 hours daily patching
421378|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421379|NCT00945100|O1|Outcome|Control|2 hours daily patching
421380|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421381|NCT00945100|O1|Outcome|Control|2 hours daily patching
421382|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421383|NCT00945100|O1|Outcome|Control|2 hours daily patching
421384|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421385|NCT00945100|O1|Outcome|Control|2 hours daily patching
421386|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421390|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421391|NCT00945100|O1|Outcome|Control|2 hours daily patching
421392|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421393|NCT00945100|O1|Outcome|Control|2 hours daily patching
421394|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421395|NCT00945100|O1|Outcome|Control|2 hours daily patching
421396|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421397|NCT00945100|O1|Outcome|Control|2 hours daily patching
421398|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421399|NCT00945100|O1|Outcome|Control|2 hours daily patching
421400|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421401|NCT00945100|O1|Outcome|Control|2 hours daily patching
421402|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421403|NCT00945100|O1|Outcome|Control|2 hours daily patching
421404|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421405|NCT00945100|O1|Outcome|Control|2 hours daily patching
421406|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421407|NCT00945100|O1|Outcome|Control|2 hours daily patching
421408|NCT00945100|E2|Reported Event|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
421409|NCT00945100|E1|Reported Event|Control|2 hours daily patching
421410|NCT00945035|B1|Baseline|All Participants in Study|
421411|NCT00945035|P2|Participant Flow|Etoricoxib URC Then Etoricoxib FMI|URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image
421412|NCT00945035|P1|Participant Flow|Etoricoxib FMI Then Etoricoxib URC|FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction
421413|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
421414|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
421415|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
421416|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
421417|NCT00945035|E2|Reported Event|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
421418|NCT00945035|E1|Reported Event|Etoricoxib FMI|FMI Formulation (20%), Final Market Image
421419|NCT00944749|B1|Baseline|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
421420|NCT00944749|P1|Participant Flow|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
421421|NCT00944749|O1|Outcome|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
421422|NCT00944749|O1|Outcome|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
421423|NCT00944749|E1|Reported Event|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
421424|NCT00944710|B3|Baseline|Total|Total of all reporting groups
421425|NCT00944710|B2|Baseline|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421426|NCT00944710|B1|Baseline|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421427|NCT00944710|P2|Participant Flow|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421428|NCT00944710|P1|Participant Flow|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421429|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421430|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421431|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421432|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421433|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421434|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421435|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421436|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421437|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421438|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421439|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421440|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421441|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421442|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421535|NCT00944554|O1|Outcome|Placebo|Group given placebo twice a day or five weeks.
421443|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421444|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421445|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421446|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421447|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421448|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421449|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421450|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421451|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421452|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421453|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421454|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421455|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421456|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421457|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421458|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421459|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421460|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421461|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421462|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421463|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421464|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421465|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421466|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421467|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421468|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421469|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421470|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421471|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421472|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421473|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421474|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421475|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421476|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421477|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421478|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421479|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421480|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421481|NCT00944710|E2|Reported Event|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
421482|NCT00944710|E1|Reported Event|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
421483|NCT00944697|B3|Baseline|Total|Total of all reporting groups
421484|NCT00944697|B2|Baseline|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
421485|NCT00944697|B1|Baseline|Placebo Tablets|A placebo tablet to match the active reference treatment
421486|NCT00944697|P2|Participant Flow|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
421487|NCT00944697|P1|Participant Flow|Placebo Tablets|A placebo tablet to match the active reference treatment
421488|NCT00944697|O2|Outcome|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
421489|NCT00944697|O1|Outcome|Placebo Tablets|A placebo tablet to match the active reference treatment
421490|NCT00944697|E2|Reported Event|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
421491|NCT00944697|E1|Reported Event|Placebo Tablets|A placebo tablet to match the active reference treatment
421492|NCT00944671|B7|Baseline|Total|Total of all reporting groups
421493|NCT00944671|B6|Baseline|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
421536|NCT00944554|E2|Reported Event|Varenicline|"Experimental group given varenicline dosing.~Varenicline: Varenicline and placebo given twice a day or five weeks."
421494|NCT00944671|B5|Baseline|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
421495|NCT00944671|B4|Baseline|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
421496|NCT00944671|B3|Baseline|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
421497|NCT00944671|B2|Baseline|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
421498|NCT00944671|B1|Baseline|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
421499|NCT00944671|P6|Participant Flow|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
421500|NCT00944671|P5|Participant Flow|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
421501|NCT00944671|P4|Participant Flow|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
421502|NCT00944671|P3|Participant Flow|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
421503|NCT00944671|P2|Participant Flow|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
421504|NCT00944671|P1|Participant Flow|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
421505|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
421506|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
421507|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
421508|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
421509|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
421510|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
421511|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
421512|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
421513|NCT00944671|E3|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water
421514|NCT00944671|E2|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet Without Water|Famotidine/antacid combination EZ Chew tablet without water
421515|NCT00944671|E1|Reported Event|Famotidine/Antacid Combination Tablet With Water|Famotidine/antacid combination tablet with 120 mL of water
421516|NCT00944645|B1|Baseline|All Participants|Includes all participants from Both treatment groups; MK0524A Phase III tablet and MK0524A New Site tablet
421517|NCT00944645|P2|Participant Flow|MK0524A New Site Tablet Then MK0524A Phase III Tablet|MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)/ MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)
421518|NCT00944645|P1|Participant Flow|MK0524A Phase III Tablet Then MK0524A New Site Tablet|MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)/MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)
421519|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
421520|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
421521|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
421522|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
421523|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
421524|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
421525|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
421526|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
421527|NCT00944645|E2|Reported Event|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
421528|NCT00944645|E1|Reported Event|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
421529|NCT00944554|B3|Baseline|Total|Total of all reporting groups
421530|NCT00944554|B2|Baseline|Varenicline|"Experimental group given varenicline dosing.~Varenicline: Varenicline and placebo given twice a day or five weeks."
421531|NCT00944554|B1|Baseline|Placebo|"Group given placebo.~Placebo: Varenicline and placebo given twice a day or five weeks."
421532|NCT00944554|P2|Participant Flow|Varenicline|Experimental group given varenicline twice a day or five weeks.
421533|NCT00944554|P1|Participant Flow|Placebo|Group given placebo twice a day for 5 weeks.
421537|NCT00944554|E1|Reported Event|Placebo|"Group given placebo.~Placebo: Varenicline and placebo given twice a day or five weeks."
421538|NCT00944450|B1|Baseline|All Participants|
421539|NCT00944450|P2|Participant Flow|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
421540|NCT00944450|P1|Participant Flow|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
421541|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
421542|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
421543|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
421544|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
421545|NCT00944450|E2|Reported Event|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
421546|NCT00944450|E1|Reported Event|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
421547|NCT00944229|B1|Baseline|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
421548|NCT00944229|P1|Participant Flow|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
421549|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
421550|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
421551|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
421552|NCT00944229|E1|Reported Event|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
421553|NCT00944125|B1|Baseline|All Study Participants|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
421554|NCT00944125|P2|Participant Flow|BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
421555|NCT00944125|P1|Participant Flow|Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
421556|NCT00944125|O2|Outcome|BiV Pacing|
421557|NCT00944125|O1|Outcome|Dual Site LV Pacing|
421558|NCT00944125|E2|Reported Event|BiV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
421559|NCT00944125|E1|Reported Event|Dual Site LV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
421560|NCT00944073|B3|Baseline|Total|Total of all reporting groups
421561|NCT00944073|B2|Baseline|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421562|NCT00944073|B1|Baseline|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421563|NCT00944073|P2|Participant Flow|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421564|NCT00944073|P1|Participant Flow|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421565|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421566|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421567|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421568|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421569|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421570|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421571|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421572|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421573|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421574|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421646|NCT00944034|B12|Baseline|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
421575|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421576|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421577|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421578|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421579|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421580|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421581|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421582|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421583|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421584|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421585|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421586|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421587|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421588|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421589|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421590|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421591|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421592|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421593|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421594|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421595|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421596|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421597|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421598|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421599|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421600|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421601|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421602|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421603|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421604|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421605|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421606|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421607|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421608|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421609|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421610|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421611|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421612|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421613|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421614|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421615|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421616|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421617|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421618|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421619|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421620|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421621|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421622|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421623|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421624|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421625|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421626|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421627|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421628|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421629|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421630|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421631|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421632|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421633|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421634|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421635|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421636|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421637|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421638|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421639|NCT00944073|E2|Reported Event|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421640|NCT00944073|E1|Reported Event|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
421641|NCT00944047|B1|Baseline|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
421642|NCT00944047|P1|Participant Flow|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
421643|NCT00944047|O1|Outcome|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
421644|NCT00944047|E1|Reported Event|Intervention Arm|"Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery~nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks~trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks~Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles~cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)~Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.~Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
421645|NCT00944034|B13|Baseline|Total|Total of all reporting groups
421773|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421647|NCT00944034|B11|Baseline|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
421648|NCT00944034|B10|Baseline|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
421649|NCT00944034|B9|Baseline|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421650|NCT00944034|B8|Baseline|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421651|NCT00944034|B7|Baseline|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
421652|NCT00944034|B6|Baseline|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
421653|NCT00944034|B5|Baseline|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421654|NCT00944034|B4|Baseline|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421655|NCT00944034|B3|Baseline|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421656|NCT00944034|B2|Baseline|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421657|NCT00944034|B1|Baseline|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421658|NCT00944034|P12|Participant Flow|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
421659|NCT00944034|P11|Participant Flow|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
421660|NCT00944034|P10|Participant Flow|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
421661|NCT00944034|P9|Participant Flow|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421662|NCT00944034|P8|Participant Flow|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421663|NCT00944034|P7|Participant Flow|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
421664|NCT00944034|P6|Participant Flow|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
421665|NCT00944034|P5|Participant Flow|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421666|NCT00944034|P4|Participant Flow|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421667|NCT00944034|P3|Participant Flow|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421668|NCT00944034|P2|Participant Flow|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421669|NCT00944034|P1|Participant Flow|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age
421670|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
421671|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
421672|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
421673|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
421674|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421675|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421676|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
421677|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
421678|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
421679|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421680|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421681|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
421682|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
422071|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
421683|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421684|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421685|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421686|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421687|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421688|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
421689|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
421690|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
421691|NCT00944034|O8|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
421692|NCT00944034|O7|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
421693|NCT00944034|O6|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421694|NCT00944034|O5|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421695|NCT00944034|O4|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
421696|NCT00944034|O3|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421697|NCT00944034|O2|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421698|NCT00944034|O1|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421699|NCT00944034|O4|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
421700|NCT00944034|O3|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
421701|NCT00944034|O2|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421702|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421703|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421704|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421705|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
421706|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
421707|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421708|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421709|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421710|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421711|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421712|NCT00944034|O3|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421713|NCT00944034|O2|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421714|NCT00944034|O1|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
421715|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
421716|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421717|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421718|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421719|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421720|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421721|NCT00944034|E12|Reported Event|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
421722|NCT00944034|E11|Reported Event|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
421723|NCT00944034|E10|Reported Event|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
421724|NCT00944034|E9|Reported Event|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421725|NCT00944034|E8|Reported Event|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421726|NCT00944034|E7|Reported Event|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
421727|NCT00944034|E6|Reported Event|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
421728|NCT00944034|E5|Reported Event|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
421729|NCT00944034|E4|Reported Event|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421730|NCT00944034|E3|Reported Event|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
421731|NCT00944034|E2|Reported Event|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
421732|NCT00944034|E1|Reported Event|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
421733|NCT00944021|B6|Baseline|Total|Total of all reporting groups
421734|NCT00944021|B5|Baseline|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421735|NCT00944021|B4|Baseline|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421736|NCT00944021|B3|Baseline|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421737|NCT00944021|B2|Baseline|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421738|NCT00944021|B1|Baseline|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421739|NCT00944021|P5|Participant Flow|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421740|NCT00944021|P4|Participant Flow|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421741|NCT00944021|P3|Participant Flow|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421742|NCT00944021|P2|Participant Flow|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421743|NCT00944021|P1|Participant Flow|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421744|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421745|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421746|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421747|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421748|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421749|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421750|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421751|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421752|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421753|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421754|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421755|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421756|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421757|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421758|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421759|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421760|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421761|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421762|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421763|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421764|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421765|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421766|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421767|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421768|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421769|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421770|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421771|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421772|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421774|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421775|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421776|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421777|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421778|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421779|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421780|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421781|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421782|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421783|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421784|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421785|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421786|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421787|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421788|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421789|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421790|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421791|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421792|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421793|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421794|NCT00944021|E5|Reported Event|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
421795|NCT00944021|E4|Reported Event|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
421796|NCT00944021|E3|Reported Event|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
421797|NCT00944021|E2|Reported Event|PA-824 100mg/qd|PA-824 : 100mg oral tablet
421798|NCT00944021|E1|Reported Event|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
421799|NCT00943917|B16|Baseline|Total|Total of all reporting groups
421800|NCT00943917|B15|Baseline|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
421801|NCT00943917|B14|Baseline|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
421802|NCT00943917|B13|Baseline|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
421803|NCT00943917|B12|Baseline|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
421804|NCT00943917|B11|Baseline|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
421805|NCT00943917|B10|Baseline|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
421806|NCT00943917|B9|Baseline|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
421807|NCT00943917|B8|Baseline|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
421808|NCT00943917|B7|Baseline|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
421809|NCT00943917|B6|Baseline|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
421810|NCT00943917|B5|Baseline|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
421811|NCT00943917|B4|Baseline|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
421812|NCT00943917|B3|Baseline|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
421813|NCT00943917|B2|Baseline|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
421814|NCT00943917|B1|Baseline|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
421815|NCT00943917|P15|Participant Flow|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
421816|NCT00943917|P14|Participant Flow|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
421817|NCT00943917|P13|Participant Flow|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
421818|NCT00943917|P12|Participant Flow|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
421819|NCT00943917|P11|Participant Flow|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
421820|NCT00943917|P10|Participant Flow|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
421821|NCT00943917|P9|Participant Flow|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
421822|NCT00943917|P8|Participant Flow|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
421823|NCT00943917|P7|Participant Flow|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
421824|NCT00943917|P6|Participant Flow|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
421825|NCT00943917|P5|Participant Flow|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
421826|NCT00943917|P4|Participant Flow|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
422072|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
421827|NCT00943917|P3|Participant Flow|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
421828|NCT00943917|P2|Participant Flow|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
421829|NCT00943917|P1|Participant Flow|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
421830|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
421831|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
421832|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
421833|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
421834|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
421835|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
421836|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
421837|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
421838|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
421839|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
421840|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
421841|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II Continuation
421842|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
421843|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
421844|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
421845|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
421846|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
421847|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
421848|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
421849|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
421850|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
421851|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
421852|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
421853|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II & Stage II Continuation
421854|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
421855|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
421856|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
421857|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
421858|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
421859|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
421860|NCT00943917|E15|Reported Event|Ex Inj/ITCA 650 60 Continutation|Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
421861|NCT00943917|E14|Reported Event|Ex Inj/ITCA 40 Continuation|Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
421862|NCT00943917|E13|Reported Event|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
421863|NCT00943917|E12|Reported Event|ITCA 650 40/40 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
421864|NCT00943917|E11|Reported Event|ITCA 650 20/60 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
421865|NCT00943917|E10|Reported Event|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
421866|NCT00943917|E9|Reported Event|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
421867|NCT00943917|E8|Reported Event|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
421868|NCT00943917|E7|Reported Event|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
421869|NCT00943917|E6|Reported Event|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
421870|NCT00943917|E5|Reported Event|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
421871|NCT00943917|E4|Reported Event|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
421872|NCT00943917|E3|Reported Event|Exenatide Injection|exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
421873|NCT00943917|E2|Reported Event|ITCA 650 40 mcg/Day|ITCA 650 40 mcg/day continuous exenatide
421874|NCT00943917|E1|Reported Event|ITCA 650 20 mcg/Day|ITCA 650 20 mcg/day continuous exenatide
421875|NCT00943878|B5|Baseline|Total|Total of all reporting groups
421876|NCT00943878|B4|Baseline|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421877|NCT00943878|B3|Baseline|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421878|NCT00943878|B2|Baseline|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421879|NCT00943878|B1|Baseline|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421880|NCT00943878|P4|Participant Flow|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422073|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
421881|NCT00943878|P3|Participant Flow|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421882|NCT00943878|P2|Participant Flow|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421883|NCT00943878|P1|Participant Flow|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421884|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421885|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421886|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421887|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421888|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421889|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421890|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421891|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421892|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421893|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421894|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421895|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421896|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421897|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421898|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421899|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421900|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421901|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421902|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421903|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421904|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421905|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421906|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421907|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421908|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421909|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421910|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
422939|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
421911|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421912|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421913|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421914|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421915|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421916|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421917|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421918|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421919|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421920|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421921|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421922|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421923|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421924|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421925|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421926|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421927|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421928|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421929|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421930|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421931|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421932|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421933|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421934|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421935|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421936|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421937|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421938|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421939|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421940|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422940|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
421941|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421942|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421943|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421944|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421945|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421946|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421947|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421948|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421949|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421950|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421951|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421952|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421953|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421954|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421955|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421956|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421957|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421958|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421959|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421960|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421961|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421962|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421963|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421964|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421965|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421966|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421967|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421968|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421969|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421970|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
422941|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
421971|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421972|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421973|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421974|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421975|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421976|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421977|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421978|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421979|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421980|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421981|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421982|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421983|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421984|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421985|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421986|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421987|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421988|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421989|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421990|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421991|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421992|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421993|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421994|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421995|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421996|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
421997|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
421998|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
421999|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422000|NCT00943878|E4|Reported Event|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422942|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422001|NCT00943878|E3|Reported Event|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
422002|NCT00943878|E2|Reported Event|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
422003|NCT00943878|E1|Reported Event|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422004|NCT00943852|B1|Baseline|All Participants in Study|
422005|NCT00943852|P10|Participant Flow|Losartan + ISMN / Losartan / Placebo / Losartan + ISMN / ISMN|Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / Placebo / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
422006|NCT00943852|P9|Participant Flow|Losartan + ISMN / Placebo / Losartan + ISMN / ISMN / Losartan|Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
422007|NCT00943852|P8|Participant Flow|ISMN / Losartan + ISMN / Losartan + ISMN / Losartan / Placebo|ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg / Placebo – single dose with ≥ 4 days washout between doses
422008|NCT00943852|P7|Participant Flow|Losartan / Losartan + ISMN / ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
422009|NCT00943852|P6|Participant Flow|Placebo / ISMN / Losartan / Losartan + ISMN / Losartan + ISMN|Placebo / ISMN 60 mg / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
422010|NCT00943852|P5|Participant Flow|Losartan + ISMN / Placebo / ISMN / Losartan + ISMN / Losartan|Losartan 100 mg + ISMN 60 mg / Placebo / ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
422011|NCT00943852|P4|Participant Flow|Losartan + ISMN / Losartan + ISMN / Losartan / ISMN / Placebo|Losartan 100 mg + ISMN 15 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / ISMN 60 mg / Placebo – single dose with ≥ 4 days washout between doses
422012|NCT00943852|P3|Participant Flow|ISMN / Losartan + ISMN / Placebo / Losartan / Losartan + ISMN|ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
422013|NCT00943852|P2|Participant Flow|Losartan / ISMN / Losartan + ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
422014|NCT00943852|P1|Participant Flow|Placebo / Losartan / Losartan + ISMN / Losartan + ISMN / ISMN|Placebo / Losartan 100 mg / Losartan 100 mg + Isosorbide Mononitrate (ISMN) 15 mg / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
422015|NCT00943852|O2|Outcome|Placebo|
422016|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
422017|NCT00943852|O2|Outcome|Losartan 100 mg|
422018|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
422019|NCT00943852|E5|Reported Event|ISMN 60 mg|
422020|NCT00943852|E4|Reported Event|Losartan 100 mg + ISMN 60 mg|
422021|NCT00943852|E3|Reported Event|Losartan 100 mg + ISMN 15 mg|
422022|NCT00943852|E2|Reported Event|Losartan 100 mg|
422023|NCT00943852|E1|Reported Event|Placebo|
422024|NCT00943826|B3|Baseline|Total|Total of all reporting groups
422025|NCT00943826|B2|Baseline|Placebo + RT +Temozolomide|In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422026|NCT00943826|B1|Baseline|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422027|NCT00943826|P2|Participant Flow|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422074|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422075|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422076|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422077|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422028|NCT00943826|P1|Participant Flow|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422029|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422030|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422031|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422032|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422033|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422034|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422035|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422036|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422037|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422038|NCT00943826|O1|Outcome|Bevacizumab + RT +Temozolomide|In the Concurrent Phase participants received RT in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
422039|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422040|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422041|NCT00943826|O2|Outcome|Placebo + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422042|NCT00943826|O1|Outcome|Bevacizumab + RT + Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gray (Gy) given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 milligrams per square meter (mg/m^2) daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab (Avastin) 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422043|NCT00943826|E2|Reported Event|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422078|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422079|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422044|NCT00943826|E1|Reported Event|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per weeks for 6 weeks (for a total of 60 Gy) and temozolomide 75 mg/m^2 daily from the first day to the last day of radiotherapy (for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity. Participants then entered the last period: After Primary Overall Survival Analysis, in which participants were followed up for safety.
422045|NCT00943787|B1|Baseline|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
422046|NCT00943787|P1|Participant Flow|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
422047|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
422048|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
422049|NCT00943787|E1|Reported Event|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
422050|NCT00943761|B3|Baseline|Total|Total of all reporting groups
422051|NCT00943761|B2|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
422052|NCT00943761|B1|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
422053|NCT00943761|P2|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
422054|NCT00943761|P1|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
422055|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
422056|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
422057|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
422058|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
422059|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
422060|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
422061|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
422062|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
422063|NCT00943761|E2|Reported Event|Vaniprevir 600 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
422064|NCT00943761|E1|Reported Event|Vaniprevir 300 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
422065|NCT00943735|B1|Baseline|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422066|NCT00943735|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422067|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422068|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422069|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422070|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422943|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422080|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422081|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422082|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422083|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422084|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422085|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422086|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422087|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422088|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422089|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422090|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422091|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422092|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422093|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422094|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422095|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422096|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422097|NCT00943735|E1|Reported Event|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
422098|NCT00943722|B6|Baseline|Total|Total of all reporting groups
422099|NCT00943722|B5|Baseline|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422100|NCT00943722|B4|Baseline|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422101|NCT00943722|B3|Baseline|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
422102|NCT00943722|B2|Baseline|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
422103|NCT00943722|B1|Baseline|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422104|NCT00943722|P5|Participant Flow|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422105|NCT00943722|P4|Participant Flow|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422106|NCT00943722|P3|Participant Flow|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
422107|NCT00943722|P2|Participant Flow|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
422108|NCT00943722|P1|Participant Flow|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422109|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
422110|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
422111|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422112|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422113|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422114|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422115|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422116|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422117|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422118|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2, or 3)|Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
422119|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422120|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422339|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422121|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
422122|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422123|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422124|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
422125|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
422126|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
422127|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422128|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422129|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422130|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422131|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422132|NCT00943722|E3|Reported Event|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422133|NCT00943722|E2|Reported Event|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
422134|NCT00943722|E1|Reported Event|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
422135|NCT00943683|B3|Baseline|Total|Total of all reporting groups
422136|NCT00943683|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
422137|NCT00943683|B1|Baseline|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
422138|NCT00943683|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
422139|NCT00943683|P1|Participant Flow|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
422140|NCT00943683|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
422141|NCT00943683|O1|Outcome|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
422142|NCT00943683|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
422143|NCT00943683|E1|Reported Event|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
422144|NCT00943670|B1|Baseline|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
422145|NCT00943670|P1|Participant Flow|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
422146|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422147|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422148|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422149|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422150|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422181|NCT00943631|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422151|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422152|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422153|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
422154|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422155|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
422156|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422157|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
422158|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
422159|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
422160|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
422161|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422162|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422163|NCT00943670|O3|Outcome|Baseline-adjusted QTc Interval > 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422164|NCT00943670|O2|Outcome|Baseline-adjusted QTc Interval > 30 to ≤ 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 30 and less than or equal to 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422165|NCT00943670|O1|Outcome|Baseline-adjusted QTc Interval ≤ 30 ms|Participants with an average Baseline-adjusted QTc interval less than or equal to 30 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422166|NCT00943670|O4|Outcome|Average QTc Interval > 500 ms|Participants with an average QTc interval greater than 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422167|NCT00943670|O3|Outcome|Average QTc Interval > 480 to ≤ 500 ms|Participants with an average QTc interval greater than 480 and less than or equal to 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422168|NCT00943670|O2|Outcome|Average QTc Interval > 450 to ≤ 480 ms|Participants with an average QTc interval greater than 450 and less than or equal to 480 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422169|NCT00943670|O1|Outcome|Average QTc Interval ≤ 450 ms|Participants with an average QTc interval less than or equal to 450 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422170|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422171|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422172|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422173|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422174|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422175|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422176|NCT00943670|E2|Reported Event|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
422177|NCT00943670|E1|Reported Event|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
422178|NCT00943631|B3|Baseline|Total|Total of all reporting groups
422179|NCT00943631|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422180|NCT00943631|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422182|NCT00943631|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422183|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422184|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422185|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422186|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422187|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422188|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422189|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422190|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422191|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422192|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422193|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422194|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422195|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422196|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422197|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422198|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422199|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422200|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422201|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422202|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422203|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422204|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422205|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422206|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422207|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422208|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422209|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422210|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422211|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422212|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422213|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422214|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422215|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422216|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422217|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422218|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422219|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422220|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422221|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422222|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422223|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422224|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422225|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422226|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422227|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422228|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422229|NCT00943631|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422230|NCT00943631|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422231|NCT00943605|B3|Baseline|Total|Total of all reporting groups
422232|NCT00943605|B2|Baseline|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
422233|NCT00943605|B1|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
422234|NCT00943605|P2|Participant Flow|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
422235|NCT00943605|P1|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
422236|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
422237|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
422238|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
422239|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
422240|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
422241|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
422242|NCT00943605|E2|Reported Event|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
422243|NCT00943605|E1|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
422244|NCT00943592|B1|Baseline|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422245|NCT00943592|P1|Participant Flow|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422246|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422247|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422248|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422249|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422250|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422251|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422252|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422253|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422254|NCT00943592|E1|Reported Event|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
422255|NCT00943579|B3|Baseline|Total|Total of all reporting groups
422944|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422256|NCT00943579|B2|Baseline|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422257|NCT00943579|B1|Baseline|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422258|NCT00943579|P2|Participant Flow|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422259|NCT00943579|P1|Participant Flow|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422260|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422261|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422262|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422263|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422264|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422265|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422266|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422267|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422268|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422269|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422270|NCT00943579|O1|Outcome|Kuvan®|"Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks.~Kuvan®: Brand-name Kuvan® (sapropterin) will be administered to all subjects at a dose of 20 mg/kg/day for 16 weeks."
422271|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|
422272|NCT00943579|O1|Outcome|Kuvan Following Placebo|
422273|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422274|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422275|NCT00943579|E2|Reported Event|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
422276|NCT00943579|E1|Reported Event|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
422277|NCT00943488|B3|Baseline|Total|Total of all reporting groups
422278|NCT00943488|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422279|NCT00943488|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422280|NCT00943488|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422281|NCT00943488|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422282|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422283|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422284|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422285|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422286|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422287|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422288|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422289|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422290|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422291|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422292|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422293|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422294|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422295|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422296|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422297|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422298|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422299|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422300|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422301|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422302|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422303|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422304|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422305|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422306|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422307|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422308|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422309|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422310|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422311|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422312|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422313|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422314|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422315|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422316|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422317|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422318|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422319|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422320|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422321|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422322|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422323|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422324|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422325|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422326|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422327|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422328|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422329|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422330|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422331|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422332|NCT00943488|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422333|NCT00943488|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
422334|NCT00943436|B3|Baseline|Total|Total of all reporting groups
422335|NCT00943436|B2|Baseline|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422336|NCT00943436|B1|Baseline|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422337|NCT00943436|P2|Participant Flow|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422338|NCT00943436|P1|Participant Flow|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422340|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422341|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422342|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422343|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422344|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422345|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422346|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422347|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422348|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422349|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422350|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422351|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422352|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422353|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422354|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422355|NCT00943436|E2|Reported Event|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
422356|NCT00943436|E1|Reported Event|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
422357|NCT00943397|B3|Baseline|Total|Total of all reporting groups
422358|NCT00943397|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
422359|NCT00943397|B1|Baseline|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
422360|NCT00943397|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
422361|NCT00943397|P1|Participant Flow|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
422362|NCT00943397|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
422363|NCT00943397|O1|Outcome|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
422364|NCT00943397|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
422365|NCT00943397|E1|Reported Event|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
422366|NCT00943384|B1|Baseline|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422367|NCT00943384|P1|Participant Flow|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422368|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422369|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422370|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422371|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422372|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422373|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422374|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422406|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422375|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422376|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422377|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422378|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422379|NCT00943384|E1|Reported Event|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
422380|NCT00943306|B1|Baseline|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422381|NCT00943306|P1|Participant Flow|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422382|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422383|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422384|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422385|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422386|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422387|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422388|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422389|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422390|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422391|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422392|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422393|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422394|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422395|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422396|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422397|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422398|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422399|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422400|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422401|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422402|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422403|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422404|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422405|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422407|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422408|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422409|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422410|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422411|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422412|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422413|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422414|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422415|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422416|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422417|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422418|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422419|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422420|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422421|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422422|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422423|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422424|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422425|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422426|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422427|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422428|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422429|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422430|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422431|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422432|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422433|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422434|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422435|NCT00943306|O1|Outcome|Lomitapide|"Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422436|NCT00943306|E1|Reported Event|Lomitapide|"Maximum tolerated dose of lomitapide (up to 80mg/day) in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.~lomitapide: 5-60 mg po every day"
422437|NCT00943202|B5|Baseline|Total|Total of all reporting groups
422438|NCT00943202|B4|Baseline|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422439|NCT00943202|B3|Baseline|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422440|NCT00943202|B2|Baseline|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422441|NCT00943202|B1|Baseline|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422442|NCT00943202|P4|Participant Flow|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422443|NCT00943202|P3|Participant Flow|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422444|NCT00943202|P2|Participant Flow|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422445|NCT00943202|P1|Participant Flow|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422446|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422447|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422448|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422449|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422450|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422451|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422452|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422453|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422454|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422455|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422456|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422457|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422458|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422459|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422460|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422461|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422462|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422463|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422464|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422465|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422466|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422467|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422468|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422469|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422470|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422471|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422472|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422473|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422474|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422475|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422476|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422945|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422477|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422478|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422479|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422480|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422481|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422482|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422483|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422484|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422485|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422486|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422487|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422488|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422489|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422490|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422491|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422492|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422493|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422494|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422495|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422496|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422497|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422498|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422499|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422500|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422501|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422502|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422503|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422504|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422505|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422506|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422507|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422508|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422509|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422510|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422511|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422946|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422512|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422513|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422514|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422515|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422516|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422517|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422518|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422519|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422520|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422521|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422522|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422523|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422524|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422525|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422526|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422527|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422528|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422529|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422530|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422531|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422532|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422533|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422534|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422535|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422536|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422537|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422538|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422539|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422540|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422541|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422542|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422543|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422544|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422545|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422546|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422947|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422547|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422548|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422549|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422550|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422551|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422552|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422553|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422554|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422555|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422556|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422557|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422558|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422559|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422560|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422561|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422562|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422563|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422564|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422565|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422566|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422567|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422568|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422569|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422570|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422571|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422572|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422573|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422574|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422575|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422576|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422577|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422578|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422579|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422580|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422581|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422948|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422582|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422583|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422584|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422585|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422586|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422587|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422588|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422589|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422590|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422591|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422592|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422593|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422594|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422595|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422596|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422597|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422598|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422599|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422600|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422601|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422602|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422603|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422604|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422605|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422606|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422607|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422608|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422609|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422610|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422611|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422612|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422613|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422614|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422615|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422616|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422949|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422617|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422618|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422619|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422620|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422621|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422622|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422623|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422624|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422625|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422626|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422627|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422628|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422629|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422630|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422631|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422632|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422633|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422634|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422635|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422636|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422637|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422638|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422639|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422640|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422641|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422642|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422643|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422644|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422645|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422646|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422647|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422648|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422649|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422650|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422651|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422950|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422652|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422653|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422654|NCT00943202|E4|Reported Event|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
422655|NCT00943202|E3|Reported Event|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
422656|NCT00943202|E2|Reported Event|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
422657|NCT00943202|E1|Reported Event|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
422658|NCT00943150|B3|Baseline|Total|Total of all reporting groups
422659|NCT00943150|B2|Baseline|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422660|NCT00943150|B1|Baseline|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422661|NCT00943150|P2|Participant Flow|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422662|NCT00943150|P1|Participant Flow|PEAK PlasmaBlade|The PEAK PlasmaBlade for the abdominoplasty procedure.
422663|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422664|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422665|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422666|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422667|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422668|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422669|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422670|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422671|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422672|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422673|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422674|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422675|NCT00943150|O3|Outcome|Scalpel|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
422676|NCT00943150|O2|Outcome|Electrosurgery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
422677|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
422678|NCT00943150|O2|Outcome|Electrocautery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
422679|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
422680|NCT00943150|E2|Reported Event|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
422681|NCT00943150|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
422682|NCT00943124|B1|Baseline|Overall Study Population|All randomized patients
422683|NCT00943124|P2|Participant Flow|Simvastatin + MK0524A Then MK0524B|"Period 1: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets.~Period 2: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet)."
422684|NCT00943124|P1|Participant Flow|MK0524B Then Simvastatin + MK0524A|"Period 1: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet).~Period 2: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets."
422685|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422686|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422687|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422688|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422689|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422690|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422691|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422951|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422692|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422693|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422694|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422695|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422696|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422697|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422698|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422699|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422700|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422701|NCT00943124|E2|Reported Event|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
422702|NCT00943124|E1|Reported Event|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
422703|NCT00943111|B3|Baseline|Total|Total of all reporting groups
422704|NCT00943111|B2|Baseline|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422705|NCT00943111|B1|Baseline|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422706|NCT00943111|P3|Participant Flow|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was <5 ng/mL next higher dose was administered whereas if the Genz-99067 trough plasma concentration was >=5 ng/mL the same dose was continued. PK assessment at Week 54 and Week 58 were used for dose adjustment after Week 56 and Week 60, respectively."
422707|NCT00943111|P2|Participant Flow|Imiglucerase: PAP|Imiglucerase (Cerezyme®) intravenous infusion every other week (q2w) up to Week 52 in doses equivalent to participant’s past enzyme replacement therapy (ERT) dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422708|NCT00943111|P1|Participant Flow|Eliglustat: PAP|Eliglustat tartrate (Genz-112638) capsule 50 milligram (mg) twice daily (BID) orally from Day 1 to Week 4 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 8, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 52. The dose adjustments after Week 4 and Week 8 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was less than [<] 5 nanogram per milliliter [ng/mL] the next higher dose was administered whereas if the Genz-99067 trough plasma concentration was greater than or equal to [>=] 5 ng/mL the same dose was continued. The pharmacokinetic (PK) assessment at Week 2 and Week 6 were used for dose adjustment after Week 4 and Week 8, respectively.
422709|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
422710|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
422711|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
422736|NCT00943111|E2|Reported Event|Imiglucerase|PAP: Imiglucerase (Cerezyme®) intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change. LTTP: Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations.
422712|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
422713|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
422714|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
422715|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422716|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422717|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422718|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422719|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422720|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422721|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422722|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422723|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422724|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422725|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422726|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422727|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422728|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422729|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422730|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422731|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422732|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422733|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
422734|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
422735|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
422737|NCT00943111|E1|Reported Event|Eliglustat|PAP: Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52. Dose adjustments after Week 4 and Week 8 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. LTTP: Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
422738|NCT00943098|B3|Baseline|Total|Total of all reporting groups
422739|NCT00943098|B2|Baseline|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422740|NCT00943098|B1|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422741|NCT00943098|P2|Participant Flow|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422742|NCT00943098|P1|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422743|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422744|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422745|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422746|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422747|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422748|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422749|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422750|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422751|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422752|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422753|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422754|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422755|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422756|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422757|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422758|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422759|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422760|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422761|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422762|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422763|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422764|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422765|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422766|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422767|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422768|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422769|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422770|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422771|NCT00943098|E2|Reported Event|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
422772|NCT00943098|E1|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
422773|NCT00943072|B3|Baseline|Total|Total of all reporting groups
422774|NCT00943072|B2|Baseline|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
422775|NCT00943072|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
422776|NCT00943072|P2|Participant Flow|Sham Treatment|"Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
422801|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422952|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422953|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422777|NCT00943072|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
422778|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
422779|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
422780|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
422781|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
422782|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
422783|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
422784|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
422785|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
422786|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
422787|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
422788|NCT00943072|E4|Reported Event|Sham Treatment to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
422789|NCT00943072|E3|Reported Event|IAI to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
422790|NCT00943072|E2|Reported Event|Sham Treatment (Baseline to Week 24)|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
422791|NCT00943072|E1|Reported Event|Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.~Participants in the safety population were at risk."
422792|NCT00942994|B3|Baseline|Total|Total of all reporting groups
422793|NCT00942994|B2|Baseline|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422794|NCT00942994|B1|Baseline|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422795|NCT00942994|P2|Participant Flow|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422796|NCT00942994|P1|Participant Flow|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422797|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422798|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422799|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422800|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422930|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422802|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422803|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422804|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422805|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422806|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422807|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422808|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422809|NCT00942994|E2|Reported Event|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
422810|NCT00942994|E1|Reported Event|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
422811|NCT00942968|B1|Baseline|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422812|NCT00942968|P1|Participant Flow|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422813|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422814|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422815|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422816|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422817|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422818|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422819|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422820|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422821|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422822|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422823|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422824|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422825|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422931|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422826|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422827|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422828|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422829|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422830|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422831|NCT00942968|E1|Reported Event|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
422832|NCT00942903|B1|Baseline|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
422833|NCT00942903|P1|Participant Flow|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
422834|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
422835|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
422836|NCT00942903|E1|Reported Event|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
422837|NCT00942890|B3|Baseline|Total|Total of all reporting groups
422838|NCT00942890|B2|Baseline|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422839|NCT00942890|B1|Baseline|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422840|NCT00942890|P2|Participant Flow|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422841|NCT00942890|P1|Participant Flow|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 wk after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422842|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422843|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422844|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422932|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422845|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422846|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422847|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422848|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422849|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422850|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422851|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422852|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422853|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422854|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422855|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422933|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422934|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422935|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422936|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422937|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422938|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422856|NCT00942890|O2|Outcome|NMES Plus Standard Rehabilitation Protocol|"NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits."
422857|NCT00942890|O1|Outcome|Standard Rehabilitation Protocol|The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
422858|NCT00942890|E2|Reported Event|NMES w/ Rehab|"The treatment group receives NMES to the quadriceps muscle of the residual & intact limb plus rehabilitation. The therapy consists of 12-weeks of NMES using the EMPI 300PV muscle stimulator. Participants train at home for 5 days/week; each session consisted of 15-20 min of NMES to each leg eliciting 15 contractions/leg (10 sec on:50 sec off), plus a 5-min tx log. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental.~NMES plus standard of care: In addition to the standard rehabilitation, the NMES treatment group will receive NMES to the quadriceps muscle of the residual & intact limb. EMPI 300PV is the NMES device. NMES training will consist of performing 15-20 minute stimulation sessions with a 5-minute patient tx log, 5 times/week for 12 weeks. During each session, 15 NMES contractions/leg will be completed at home. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device."
422859|NCT00942890|E1|Reported Event|Standard Rehabilitation Protocol|"The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1-week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for ~6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with the prosthetic leg and began post-prosthetic training. The training focus is lower limb prosthetic proficient in ambulation.~NMES (EMPI 300PV) plus standard of care: In addition to the standard rehabilitation, the NMES group will receive NMES to the quadriceps muscle of the residual & intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of 15-20 minute stimulation sessions with a 5-minute patient treatment log, 5 times/week for 12 weeks. During each session, 15 NMES contractions/leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home."
422860|NCT00942851|B3|Baseline|Total|Total of all reporting groups
422861|NCT00942851|B2|Baseline|Placebo|topical intervention WITHOUT AH-8
422862|NCT00942851|B1|Baseline|Active|AH-8 containing topical intervention
422863|NCT00942851|P2|Participant Flow|Placebo|"Topical intervention agent WITHOUT AH-8. Identically appearing cream without the active ingredient.~Twice daily application to the eyelids in standardized fashion."
422864|NCT00942851|P1|Participant Flow|Active|Topical intervention agent containing AH8 0.005% Twice daily application to the eyelids in standardized fashion.
422865|NCT00942851|O2|Outcome|Placebo|topical intervention WITHOUT AH-8
422866|NCT00942851|O1|Outcome|Active|AH-8 containing topical intervention
422867|NCT00942851|O2|Outcome|Placebo|
422868|NCT00942851|O1|Outcome|Active Ingredient- AH8|
422869|NCT00942851|O2|Outcome|Placebo|subjects receiving placebo intervention, ie identically-appearing topical cream without AH-8 content
422870|NCT00942851|O1|Outcome|Active Ingredient- AH8|subjects receiving active intervention, ie topical cream containing 0.005% AH-8
422871|NCT00942851|E2|Reported Event|Placebo|topical intervention WITHOUT AH-8
422872|NCT00942851|E1|Reported Event|Active|AH-8 containing topical intervention
422873|NCT00942825|B3|Baseline|Total|Total of all reporting groups
422874|NCT00942825|B2|Baseline|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422875|NCT00942825|B1|Baseline|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422876|NCT00942825|P2|Participant Flow|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422877|NCT00942825|P1|Participant Flow|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422878|NCT00942825|O2|Outcome|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422879|NCT00942825|O1|Outcome|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422880|NCT00942825|E2|Reported Event|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422881|NCT00942825|E1|Reported Event|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
422882|NCT00942786|B1|Baseline|One Arm|consecutive patients presenting for emergent non-cardiac surgery
422883|NCT00942786|P1|Participant Flow|No Treatment|Consecutive patients undergoing emergency surgery
422884|NCT00942786|O2|Outcome|Patients Not Sustaining Adverse Events|Subjects who did not reach the primary endpoint
422885|NCT00942786|O1|Outcome|Patients Sustaining Adverse Events|Subjects who reached the primary endpoint
422886|NCT00942786|O1|Outcome|All Patients|Consecutive patients undergoing emergent non-cardiac surgery
422887|NCT00942786|O1|Outcome|No Treatment|Consecutive patients undergoing emergency surgery
422888|NCT00942786|E1|Reported Event|One Arm|"consecutive patients presenting for emergent non-cardiac surgery~Patients were followed for occurence of major adverse cardiac events"
422889|NCT00942734|B1|Baseline|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
422890|NCT00942734|P1|Participant Flow|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
422891|NCT00942734|O1|Outcome|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
422892|NCT00942734|E1|Reported Event|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
422893|NCT00942604|B3|Baseline|Total|Total of all reporting groups
422894|NCT00942604|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
422895|NCT00942604|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
422896|NCT00942604|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
422897|NCT00942604|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
422898|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
422899|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
422900|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
422901|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
422902|NCT00942604|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
422903|NCT00942604|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
422904|NCT00942448|B5|Baseline|Total|Total of all reporting groups
422905|NCT00942448|B4|Baseline|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
422906|NCT00942448|B3|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422907|NCT00942448|B2|Baseline|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422908|NCT00942448|B1|Baseline|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422909|NCT00942448|P4|Participant Flow|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
422910|NCT00942448|P3|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422911|NCT00942448|P2|Participant Flow|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422912|NCT00942448|P1|Participant Flow|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422913|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
422914|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422915|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422916|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422917|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422918|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422919|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422920|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422921|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422922|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422923|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422924|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422925|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422926|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422927|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422928|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422929|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422954|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422955|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422956|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422957|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422958|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422959|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422960|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422961|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
422962|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
422963|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
422964|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
422965|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
422966|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422967|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422968|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422969|NCT00942448|E4|Reported Event|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
422970|NCT00942448|E3|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422971|NCT00942448|E2|Reported Event|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422972|NCT00942448|E1|Reported Event|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
422973|NCT00942422|B1|Baseline|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal). Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
422974|NCT00942422|P1|Participant Flow|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
422975|NCT00942422|O1|Outcome|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~defined green tea catechin extract: Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
422976|NCT00942422|E1|Reported Event|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
422977|NCT00942409|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
422978|NCT00942409|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
422979|NCT00942409|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
422980|NCT00942409|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
422981|NCT00942266|B3|Baseline|Total|Total of all reporting groups
422982|NCT00942266|B2|Baseline|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422983|NCT00942266|B1|Baseline|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
423004|NCT00942188|B3|Baseline|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423547|NCT00940823|O2|Outcome|Baerveldt Group|Baerveldt-350 Implant
422984|NCT00942266|P2|Participant Flow|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422985|NCT00942266|P1|Participant Flow|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422986|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422987|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422988|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422989|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422990|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422991|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422992|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422993|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422994|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422995|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422996|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422997|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422998|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
422999|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
423000|NCT00942266|E2|Reported Event|Arm II|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
423001|NCT00942266|E1|Reported Event|Arm I|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
423002|NCT00942188|B5|Baseline|Total|Total of all reporting groups
423003|NCT00942188|B4|Baseline|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423005|NCT00942188|B2|Baseline|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423006|NCT00942188|B1|Baseline|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423007|NCT00942188|P4|Participant Flow|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423008|NCT00942188|P3|Participant Flow|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423009|NCT00942188|P2|Participant Flow|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423010|NCT00942188|P1|Participant Flow|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423011|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423012|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423013|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423014|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423015|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423016|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423017|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423018|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423019|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423020|NCT00942188|O4|Outcome|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423021|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423022|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423023|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423024|NCT00942188|O4|Outcome|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423025|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423026|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423027|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423028|NCT00942188|O4|Outcome|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423029|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423030|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423031|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423032|NCT00942188|O4|Outcome|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423033|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423034|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423035|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423036|NCT00942188|O4|Outcome|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423037|NCT00942188|O3|Outcome|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423038|NCT00942188|O2|Outcome|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423039|NCT00942188|O1|Outcome|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423040|NCT00942188|E4|Reported Event|Placebo|Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks.
423041|NCT00942188|E3|Reported Event|180 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423042|NCT00942188|E2|Reported Event|18 mg LY2189102|Participants received 2 SC injections weekly for 12 weeks.
423043|NCT00942188|E1|Reported Event|0.6 mg LY2189102|Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
423044|NCT00942175|B5|Baseline|Total|Total of all reporting groups
423045|NCT00942175|B4|Baseline|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
423046|NCT00942175|B3|Baseline|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
423047|NCT00942175|B2|Baseline|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
423048|NCT00942175|B1|Baseline|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
423049|NCT00942175|P4|Participant Flow|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
423050|NCT00942175|P3|Participant Flow|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
423051|NCT00942175|P2|Participant Flow|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
423052|NCT00942175|P1|Participant Flow|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
423053|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
423548|NCT00940823|O1|Outcome|Ahmed Group|Ahmed FP7 Valve Implant
423054|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423055|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
423056|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423057|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
423058|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423059|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
423060|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423061|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
423062|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423063|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
423064|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423065|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
423066|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423067|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
423068|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423069|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
423070|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423071|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
423072|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423073|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
423074|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423075|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
423076|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423077|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
423078|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423079|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
423080|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423081|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
423082|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423083|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
423084|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423085|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
423086|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423087|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
423088|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423089|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
423090|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423091|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
423092|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423093|NCT00942175|E8|Reported Event|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
423094|NCT00942175|E7|Reported Event|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423095|NCT00942175|E6|Reported Event|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
423096|NCT00942175|E5|Reported Event|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423097|NCT00942175|E4|Reported Event|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
423098|NCT00942175|E3|Reported Event|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423099|NCT00942175|E2|Reported Event|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
423202|NCT00941733|B1|Baseline|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423100|NCT00942175|E1|Reported Event|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
423101|NCT00942149|B1|Baseline|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
423102|NCT00942149|P1|Participant Flow|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
423103|NCT00942149|O1|Outcome|Area Under the Curve - 24 Hours|pharmacokinetics of daptomycin
423104|NCT00942149|E1|Reported Event|Daptomycin Cohort|
423105|NCT00942084|B1|Baseline|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423106|NCT00942084|P1|Participant Flow|Acyclovir Study Enrollment|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423107|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423108|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423109|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423110|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423111|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423112|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423113|NCT00942084|E1|Reported Event|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
423114|NCT00941993|B1|Baseline|Iontophoretic Delivery of Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423115|NCT00941993|P1|Participant Flow|Iontophoretic Delivery of Local Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423116|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423117|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423118|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423119|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423120|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423121|NCT00941993|E1|Reported Event|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
423122|NCT00941928|B1|Baseline|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
423123|NCT00941928|P1|Participant Flow|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
423124|NCT00941928|O1|Outcome|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
423125|NCT00941928|E1|Reported Event|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
423126|NCT00941889|B3|Baseline|Total|Total of all reporting groups
423127|NCT00941889|B2|Baseline|Gardasil|Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.
423128|NCT00941889|B1|Baseline|Placebo|Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.
423129|NCT00941889|P2|Participant Flow|Gardasil Group|The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
423130|NCT00941889|P1|Participant Flow|Placebo|Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.
423131|NCT00941889|O2|Outcome|Gardasil Group|Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.
423132|NCT00941889|O1|Outcome|Placebo Group|Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.
423133|NCT00941889|E2|Reported Event|Treatment Group|The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
423134|NCT00941889|E1|Reported Event|Placebo|Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.
423135|NCT00941863|B6|Baseline|Total|Total of all reporting groups
423136|NCT00941863|B5|Baseline|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
423137|NCT00941863|B4|Baseline|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
423138|NCT00941863|B3|Baseline|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
423139|NCT00941863|B2|Baseline|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
423140|NCT00941863|B1|Baseline|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
423141|NCT00941863|P5|Participant Flow|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
423142|NCT00941863|P4|Participant Flow|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
423143|NCT00941863|P3|Participant Flow|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
423144|NCT00941863|P2|Participant Flow|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
423145|NCT00941863|P1|Participant Flow|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
423146|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
423147|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
423148|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
423149|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
423150|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
423151|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
423152|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
423203|NCT00941733|P2|Participant Flow|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423153|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
423154|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
423155|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
423156|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
423157|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
423158|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
423159|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
423160|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
423161|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
423162|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
423163|NCT00941863|O1|Outcome|Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid|All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid [twice daily], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
423164|NCT00941863|E5|Reported Event|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
423165|NCT00941863|E4|Reported Event|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
423166|NCT00941863|E3|Reported Event|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
423167|NCT00941863|E2|Reported Event|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
423168|NCT00941863|E1|Reported Event|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
423169|NCT00941798|B3|Baseline|Total|Total of all reporting groups
423170|NCT00941798|B2|Baseline|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423171|NCT00941798|B1|Baseline|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423172|NCT00941798|P2|Participant Flow|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423173|NCT00941798|P1|Participant Flow|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423174|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423175|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423176|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423177|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423178|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423179|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423180|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423181|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423182|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423183|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423184|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423185|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423186|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423187|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423188|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423189|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423190|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423191|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423192|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423193|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423194|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423195|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423196|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423197|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423198|NCT00941798|E2|Reported Event|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
423199|NCT00941798|E1|Reported Event|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
423200|NCT00941733|B3|Baseline|Total|Total of all reporting groups
423201|NCT00941733|B2|Baseline|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423204|NCT00941733|P1|Participant Flow|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423205|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423206|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423207|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423208|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423209|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423210|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423211|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423212|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423213|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423214|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423215|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423216|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423217|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423218|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423219|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423220|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423221|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423222|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423223|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423224|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423225|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423226|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423227|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423228|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423229|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423230|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423231|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423232|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423233|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423234|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423235|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423236|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423237|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423238|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423239|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423240|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423241|NCT00941733|E2|Reported Event|Standard PTA|Standard PTA balloon: Balloon Angioplasty
423242|NCT00941733|E1|Reported Event|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
423243|NCT00941720|B1|Baseline|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
423244|NCT00941720|P1|Participant Flow|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
423245|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
423246|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
423247|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
423248|NCT00941720|E1|Reported Event|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
423249|NCT00941681|B4|Baseline|Total|Total of all reporting groups
423250|NCT00941681|B3|Baseline|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423251|NCT00941681|B2|Baseline|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423252|NCT00941681|B1|Baseline|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423253|NCT00941681|P3|Participant Flow|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423254|NCT00941681|P2|Participant Flow|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423255|NCT00941681|P1|Participant Flow|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423256|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423257|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423258|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423259|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423260|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423261|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423262|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423263|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423264|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423265|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423266|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423267|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423268|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423269|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423270|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423271|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423272|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423273|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423274|NCT00941681|E3|Reported Event|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
423275|NCT00941681|E2|Reported Event|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
423276|NCT00941681|E1|Reported Event|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
423277|NCT00941668|B3|Baseline|Total|Total of all reporting groups
423278|NCT00941668|B2|Baseline|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
423279|NCT00941668|B1|Baseline|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
423280|NCT00941668|P2|Participant Flow|Colgate Great Regular Flavor (Placebo)|sodium monofluorophosphate toothpaste
423281|NCT00941668|P1|Participant Flow|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
423282|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
423283|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
423284|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
423285|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
423286|NCT00941668|E2|Reported Event|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
423287|NCT00941668|E1|Reported Event|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
423288|NCT00941655|B3|Baseline|Total|Total of all reporting groups
423289|NCT00941655|B2|Baseline|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423290|NCT00941655|B1|Baseline|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423291|NCT00941655|P2|Participant Flow|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423292|NCT00941655|P1|Participant Flow|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423293|NCT00941655|O2|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423294|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423295|NCT00941655|O2|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423296|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423297|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423298|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423299|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423300|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423301|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423302|NCT00941655|O2|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423303|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423304|NCT00941655|O2|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423305|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423306|NCT00941655|O1|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423307|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423308|NCT00941655|E2|Reported Event|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
423309|NCT00941655|E1|Reported Event|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
423310|NCT00941603|B7|Baseline|Total|Total of all reporting groups
423311|NCT00941603|B6|Baseline|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
423312|NCT00941603|B5|Baseline|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423313|NCT00941603|B4|Baseline|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423314|NCT00941603|B3|Baseline|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423315|NCT00941603|B2|Baseline|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423316|NCT00941603|B1|Baseline|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423317|NCT00941603|P6|Participant Flow|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
423549|NCT00940823|E2|Reported Event|Baerveldt Group|Baerveldt-350 Implant
423318|NCT00941603|P5|Participant Flow|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423319|NCT00941603|P4|Participant Flow|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423320|NCT00941603|P3|Participant Flow|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423321|NCT00941603|P2|Participant Flow|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423322|NCT00941603|P1|Participant Flow|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423323|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
423324|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423325|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423326|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423327|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423328|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423329|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
423330|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423331|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423332|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423333|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423334|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423335|NCT00941603|E6|Reported Event|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
423336|NCT00941603|E5|Reported Event|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423337|NCT00941603|E4|Reported Event|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423338|NCT00941603|E3|Reported Event|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423339|NCT00941603|E2|Reported Event|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423340|NCT00941603|E1|Reported Event|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
423341|NCT00941330|B3|Baseline|Total|Total of all reporting groups
423342|NCT00941330|B2|Baseline|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
423343|NCT00941330|B1|Baseline|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
423344|NCT00941330|P2|Participant Flow|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
423345|NCT00941330|P1|Participant Flow|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
423346|NCT00941330|O2|Outcome|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
423347|NCT00941330|O1|Outcome|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
423348|NCT00941330|O2|Outcome|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
423349|NCT00941330|O1|Outcome|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
423350|NCT00941330|E2|Reported Event|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
423351|NCT00941330|E1|Reported Event|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
423352|NCT00941304|B6|Baseline|Total|Total of all reporting groups
423353|NCT00941304|B5|Baseline|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423354|NCT00941304|B4|Baseline|Placebo|Placebo oral capsule and 2 placebo buccal films
423355|NCT00941304|B3|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423356|NCT00941304|B2|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423357|NCT00941304|B1|Baseline|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423358|NCT00941304|P5|Participant Flow|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423359|NCT00941304|P4|Participant Flow|Placebo|Placebo oral capsule and 2 placebo buccal films
423360|NCT00941304|P3|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423361|NCT00941304|P2|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423362|NCT00941304|P1|Participant Flow|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine hydrochloride (HCl) buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423363|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423364|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423365|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423366|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423367|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423368|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423369|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423370|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423371|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423372|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423373|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423374|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423375|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423376|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423377|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423378|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423379|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423380|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423381|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423382|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423383|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423384|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423385|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423386|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423387|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423388|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423389|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423390|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423391|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423392|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423393|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423394|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423395|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423396|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423397|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423398|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423399|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423400|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423401|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423402|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423403|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423404|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423405|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423406|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423407|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423408|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423409|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423410|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423411|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423412|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423413|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423414|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
423415|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423416|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423417|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423418|NCT00941304|E5|Reported Event|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
423419|NCT00941304|E4|Reported Event|Placebo|Placebo oral capsule and 2 placebo buccal films
423420|NCT00941304|E3|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
423421|NCT00941304|E2|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423422|NCT00941304|E1|Reported Event|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
423423|NCT00941070|B1|Baseline|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423424|NCT00941070|P1|Participant Flow|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423425|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423426|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423427|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423476|NCT00940992|P3|Participant Flow|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423428|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin and undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423429|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin and undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression."
423430|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423431|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423432|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423433|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423434|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423435|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423436|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423437|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423477|NCT00940992|P2|Participant Flow|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
423438|NCT00941070|E1|Reported Event|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
423439|NCT00941031|B5|Baseline|Total|Total of all reporting groups
423440|NCT00941031|B4|Baseline|Placebo|
423441|NCT00941031|B3|Baseline|Induction Early Loading Dose|
423442|NCT00941031|B2|Baseline|Induction Monthly Dose|
423443|NCT00941031|B1|Baseline|Induction Single Dose|Baseline through Week 12
423444|NCT00941031|P7|Participant Flow|Open Label|"Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - OL: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29"
423445|NCT00941031|P6|Participant Flow|Start of Relapse|"Treatment at start of relapse regimen - SR: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
423446|NCT00941031|P5|Participant Flow|Fixed Interval|"Fixed-time interval regimen - FI: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
423447|NCT00941031|P4|Participant Flow|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
423448|NCT00941031|P3|Participant Flow|Induction Early Loading|"Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12"
423449|NCT00941031|P2|Participant Flow|Induction Monthly Dose|"Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12"
423450|NCT00941031|P1|Participant Flow|Induction Single Dose|"Induction with single injection - Single: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12"
423451|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
423452|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
423453|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
423454|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
423455|NCT00941031|O3|Outcome|Maintenance Open Label|Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
423456|NCT00941031|O2|Outcome|Maintenance Start of Relapse|Treatment at start of relapse regimen – “SR”: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
423457|NCT00941031|O1|Outcome|Maintenance Fixed Interval|Fixed-time interval regimen – “FI”: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
423458|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
423459|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
423460|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
423461|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
423462|NCT00941031|E10|Reported Event|FOLLOW-UP: Open Label|FOLLOW-UP: Open label
423463|NCT00941031|E9|Reported Event|FOLLOW-UP: Start of Relapse|FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
423464|NCT00941031|E8|Reported Event|FOLLOW-UP: Fixed Interval|FOLLOW-UP: Fixed-time interval regimen - 'FI'
423465|NCT00941031|E7|Reported Event|MAINTENANCE: Open Label|MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.
423466|NCT00941031|E6|Reported Event|MAINTENANCE: Start of Relapse|MAINTENANCE: Treatment at start of relapse regimen - 'SR'
423467|NCT00941031|E5|Reported Event|MAINTENANCE: Fixed Interval|MAINTENANCE: Fixed-time interval regimen - 'FI'
423468|NCT00941031|E4|Reported Event|INDUCTION: Placebo|INDUCTION: Placebo - 'Placebo'
423469|NCT00941031|E3|Reported Event|INDUCTION: Early|INDUCTION: with single injection - 'Single'
423470|NCT00941031|E2|Reported Event|INDUCTION: Monthly|INDUCTION: with monthly injections - 'Monthly'
423471|NCT00941031|E1|Reported Event|INDUCTION: Single|INDUCTION: Early loading induction - 'Early'
423472|NCT00940992|B4|Baseline|Total|Total of all reporting groups
423473|NCT00940992|B3|Baseline|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423474|NCT00940992|B2|Baseline|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
423475|NCT00940992|B1|Baseline|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423545|NCT00940823|O2|Outcome|Baerveldt Group|114 patients were randomized to the Ahmed Group.
423478|NCT00940992|P1|Participant Flow|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423479|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423480|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
423481|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423482|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423483|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
423484|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423485|NCT00940992|E3|Reported Event|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423486|NCT00940992|E2|Reported Event|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
423487|NCT00940992|E1|Reported Event|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
423488|NCT00940927|B1|Baseline|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
423489|NCT00940927|P1|Participant Flow|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
423490|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
423491|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
423492|NCT00940927|E1|Reported Event|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
423493|NCT00940901|B3|Baseline|Total|Total of all reporting groups
423494|NCT00940901|B2|Baseline|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then sildenafil 50 mg for weeks 9-16.
423495|NCT00940901|B1|Baseline|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks
423496|NCT00940901|P2|Participant Flow|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
423497|NCT00940901|P1|Participant Flow|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
423498|NCT00940901|O2|Outcome|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
423499|NCT00940901|O1|Outcome|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
423500|NCT00940901|O2|Outcome|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
423501|NCT00940901|O1|Outcome|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
423502|NCT00940901|E4|Reported Event|Placebo Then Sildenafil Phase 2|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
423503|NCT00940901|E3|Reported Event|Sildenafil Phase 2|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
423504|NCT00940901|E2|Reported Event|Placebo Then Sildenafil Phase 1|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
423505|NCT00940901|E1|Reported Event|Sildenafil Phase 1|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
423506|NCT00940888|B1|Baseline|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
423507|NCT00940888|P1|Participant Flow|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
423508|NCT00940888|O1|Outcome|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
423509|NCT00940888|O1|Outcome|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
423510|NCT00940888|E1|Reported Event|SJ4 System Implanted|SJ4 connector and RV high voltage SJ4 lead (SJ4 system) were implanted in subjects who received a standard of care ICD or CRT-D system for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
423511|NCT00940875|B3|Baseline|Total|Total of all reporting groups
423512|NCT00940875|B2|Baseline|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423513|NCT00940875|B1|Baseline|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423514|NCT00940875|P2|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E)|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, orally (PO), once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423546|NCT00940823|O1|Outcome|Ahmed Group|124 patients were randomized to the Ahmed Group.
423515|NCT00940875|P1|Participant Flow|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423516|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423517|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423518|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423519|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423520|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423521|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423522|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423523|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423524|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423525|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423526|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423527|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423528|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423529|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423530|NCT00940875|E2|Reported Event|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
423531|NCT00940875|E1|Reported Event|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
423532|NCT00940823|B3|Baseline|Total|Total of all reporting groups
423533|NCT00940823|B2|Baseline|Baerveldt Group|Patients received a Baerveldt-350 implant at the time of surgery.
423534|NCT00940823|B1|Baseline|Ahmed Group|Patients received an Ahmed-FP7 valve implant at the time of surgery.
423535|NCT00940823|P2|Participant Flow|Baerveldt Group|Baerveldt-350 Implant
423536|NCT00940823|P1|Participant Flow|Ahmed Group|Ahmed FP7 Valve Implant
423537|NCT00940823|O2|Outcome|Baerveldt Group|114 patients were randomized to the Ahmed Group.
423538|NCT00940823|O1|Outcome|Ahmed Group|124 patients were randomized to the Ahmed Group.
423539|NCT00940823|O2|Outcome|Baerveldt Group|114 patients were randomized to the Ahmed Group.
423540|NCT00940823|O1|Outcome|Ahmed Group|124 patients were randomized to the Ahmed Group.
423541|NCT00940823|O2|Outcome|Baerveldt Group|114 patients were randomized to the Ahmed Group.
423542|NCT00940823|O1|Outcome|Ahmed Group|124 patients were randomized to the Ahmed Group.
423543|NCT00940823|O2|Outcome|Baerveldt Group|114 patients were randomized to the Ahmed Group.
423544|NCT00940823|O1|Outcome|Ahmed Group|124 patients were randomized to the Ahmed Group.
423550|NCT00940823|E1|Reported Event|Ahmed Group|Ahmed FP7 Valve Implant
423551|NCT00940576|B1|Baseline|All Study Participants|Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively.
423552|NCT00940576|P2|Participant Flow|Oral Intake of Placebo First, Then Mare´s Milk|Oral intake of 250 ml per day placebo first, then 250 ml per day mare´s milk
423553|NCT00940576|P1|Participant Flow|Oral Intake of Mare´s Milk First, Then Placebo|Oral Intake of 250 ml per day Mare´s Milk First, Then 250 ml per day Placebo
423554|NCT00940576|O2|Outcome|Patients Ulcerative Colitis|
423555|NCT00940576|O1|Outcome|Patients Crohn´s Disease|
423556|NCT00940576|O1|Outcome|Entire Study Population|oral intake of 250 ml mare´s milk or placebo drink daily
423557|NCT00940576|E2|Reported Event|Group 2|oral intake of 250 ml placebo daily
423558|NCT00940576|E1|Reported Event|Group 1|oral intake of 250 ml mare's milk daily
423559|NCT00940537|B3|Baseline|Total|Total of all reporting groups
423560|NCT00940537|B2|Baseline|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
423561|NCT00940537|B1|Baseline|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
423562|NCT00940537|P2|Participant Flow|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
423563|NCT00940537|P1|Participant Flow|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
423564|NCT00940537|O1|Outcome|All Subjects|all subjects studied. This includes both lean and obese subjects with a range of intrahepatic triglyceride.
423565|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
423566|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
423567|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
423568|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
423569|NCT00940537|E2|Reported Event|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
423570|NCT00940537|E1|Reported Event|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
423571|NCT00940485|B3|Baseline|Total|Total of all reporting groups
423572|NCT00940485|B2|Baseline|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423573|NCT00940485|B1|Baseline|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423574|NCT00940485|P2|Participant Flow|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423575|NCT00940485|P1|Participant Flow|Peginterferon Alfa-2a + Entecavir|Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
423576|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423577|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423578|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423579|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423580|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423581|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423582|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423583|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423584|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423585|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423586|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423587|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423588|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423589|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423590|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423591|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423592|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423593|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423594|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423595|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423596|NCT00940485|E2|Reported Event|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
423597|NCT00940485|E1|Reported Event|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
423598|NCT00940446|B3|Baseline|Total|Total of all reporting groups
423599|NCT00940446|B2|Baseline|Control|Metal staple wound closure
423600|NCT00940446|B1|Baseline|Insorb Staples|Subcuticular Absorbable staples
423601|NCT00940446|P2|Participant Flow|Control|"Metal staple wound closure~Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure."
423602|NCT00940446|P1|Participant Flow|Insorb Staples|"Subcuticular Absorbable staples~Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples."
423603|NCT00940446|O2|Outcome|Control|"Metal staple wound closure~30 enrollees~Avg age~Avg BMI~Sex~Avg # staples placed~Avg incision length"
423604|NCT00940446|O1|Outcome|Insorb Staples|"Subcuticular Absorbable staples~30 enrollees~Avg age~Avg BMI~Sex~Avg # staples placed~Avg incision length"
423605|NCT00940446|O2|Outcome|Control-metal Staples|"Metal staple wound closure~Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure."
423606|NCT00940446|O1|Outcome|Insorb Staples|"Subcuticular Absorbable staples~Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples."
423607|NCT00940446|E2|Reported Event|Control|"Metal staple wound closure~Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure."
423608|NCT00940446|E1|Reported Event|Insorb Staples|"Subcuticular Absorbable staples~Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples."
423609|NCT00940290|B5|Baseline|Total|Total of all reporting groups
423610|NCT00940290|B4|Baseline|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
423611|NCT00940290|B3|Baseline|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
423612|NCT00940290|B2|Baseline|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
423613|NCT00940290|B1|Baseline|GRADE System|A clinical recommendation built and graded with the GRADE working group system
423614|NCT00940290|P4|Participant Flow|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
423615|NCT00940290|P3|Participant Flow|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
423616|NCT00940290|P2|Participant Flow|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
423617|NCT00940290|P1|Participant Flow|GRADE System|A clinical recommendation built and graded with the GRADE working group system
423618|NCT00940290|O4|Outcome|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
423619|NCT00940290|O3|Outcome|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
423620|NCT00940290|O2|Outcome|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
423621|NCT00940290|O1|Outcome|GRADE System|A clinical recommendation built and graded with the GRADE working group system
423622|NCT00940290|E4|Reported Event|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
423623|NCT00940290|E3|Reported Event|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
423624|NCT00940290|E2|Reported Event|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
423625|NCT00940290|E1|Reported Event|GRADE System|A clinical recommendation built and graded with the GRADE working group system
423626|NCT00940108|B5|Baseline|Total|Total of all reporting groups
423787|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
423627|NCT00940108|B4|Baseline|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423628|NCT00940108|B3|Baseline|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423629|NCT00940108|B2|Baseline|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423630|NCT00940108|B1|Baseline|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423631|NCT00940108|P4|Participant Flow|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423632|NCT00940108|P3|Participant Flow|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423633|NCT00940108|P2|Participant Flow|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423634|NCT00940108|P1|Participant Flow|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423635|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423636|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423637|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423638|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423639|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423640|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423641|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423642|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423643|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423644|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423645|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423646|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423647|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423648|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423649|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423650|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423651|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423652|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423653|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423654|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423655|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423656|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423657|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423658|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423659|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423660|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423661|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423662|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423663|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423664|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423665|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423666|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423667|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423668|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423669|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423670|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423671|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423672|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423673|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423674|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423675|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423676|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423677|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423678|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423679|NCT00940108|E4|Reported Event|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423680|NCT00940108|E3|Reported Event|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423681|NCT00940108|E2|Reported Event|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423682|NCT00940108|E1|Reported Event|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
423683|NCT00940017|B1|Baseline|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423684|NCT00940017|P1|Participant Flow|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423685|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423686|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423687|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423688|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423689|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423690|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423691|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423692|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423693|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423694|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423695|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423713|NCT00939991|E2|Reported Event|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423901|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423696|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423697|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423698|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423699|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423700|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423701|NCT00940017|E1|Reported Event|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
423702|NCT00939991|B3|Baseline|Total|Total of all reporting groups
423703|NCT00939991|B2|Baseline|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423704|NCT00939991|B1|Baseline|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
423705|NCT00939991|P2|Participant Flow|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423706|NCT00939991|P1|Participant Flow|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
423707|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423708|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423709|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423710|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423711|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
423712|NCT00939991|O1|Outcome|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
423785|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
423714|NCT00939991|E1|Reported Event|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
423715|NCT00939952|B1|Baseline|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423716|NCT00939952|P1|Participant Flow|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423717|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423718|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423719|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423720|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423721|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423722|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423723|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423724|NCT00939952|E1|Reported Event|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
423725|NCT00939900|B3|Baseline|Total|Total of all reporting groups
423726|NCT00939900|B2|Baseline|Control|control group
423727|NCT00939900|B1|Baseline|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
423728|NCT00939900|P2|Participant Flow|Control|control group
423729|NCT00939900|P1|Participant Flow|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
423730|NCT00939900|O2|Outcome|Control|control group
423731|NCT00939900|O1|Outcome|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
423732|NCT00939900|E2|Reported Event|Control|control group
423733|NCT00939900|E1|Reported Event|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
423734|NCT00939874|B1|Baseline|Raltegravir|Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
423735|NCT00939874|P1|Participant Flow|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
423736|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
423737|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
423738|NCT00939874|E1|Reported Event|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
423739|NCT00939809|B1|Baseline|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423740|NCT00939809|P1|Participant Flow|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423741|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423742|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423743|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423744|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423745|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423746|NCT00939809|E1|Reported Event|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
423747|NCT00939796|B1|Baseline|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
423748|NCT00939796|P1|Participant Flow|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
423749|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
423750|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
423751|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
423752|NCT00939796|E1|Reported Event|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
423786|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
423753|NCT00939783|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
423754|NCT00939783|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
423755|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
423756|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
423757|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
423758|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
423759|NCT00939783|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
423760|NCT00939731|B1|Baseline|Entire Study Population|Includes participants randomized to receive PF-02341066 250 mg IRT first and PF-02341066 250 mg PIC first.
423761|NCT00939731|P2|Participant Flow|PF-02341066 250 mg PIC First, Then PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg PIC in first intervention period; and single oral dose of PF-02341066 250 mg IRT in second intervention period. A washout period of at least 14 days was maintained between each period.
423762|NCT00939731|P1|Participant Flow|PF-02341066 250 mg IRT First, Then PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg immediate release tablet (IRT) in first intervention period; and single oral dose of PF-02341066 250 mg powder in capsule (PIC) in second intervention period. A washout period of at least 14 days was maintained between each period.
423763|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423764|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423765|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423766|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423767|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423768|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423769|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423770|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423771|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423772|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423773|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423774|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423775|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423776|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423777|NCT00939731|E2|Reported Event|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
423778|NCT00939731|E1|Reported Event|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
423779|NCT00939705|B3|Baseline|Total|Total of all reporting groups
423780|NCT00939705|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
423781|NCT00939705|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
423782|NCT00939705|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
423783|NCT00939705|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
423784|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
423788|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
423789|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
423790|NCT00939705|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
423791|NCT00939705|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
423792|NCT00939692|B3|Baseline|Total|Total of all reporting groups
423793|NCT00939692|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
423794|NCT00939692|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
423795|NCT00939692|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
423796|NCT00939692|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
423797|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
423798|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
423799|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
423800|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
423801|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
423802|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
423803|NCT00939692|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
423804|NCT00939692|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
423805|NCT00939627|B3|Baseline|Total|Total of all reporting groups
423806|NCT00939627|B2|Baseline|Arm B - Cetuximab and Sorafenib Tosylate|Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
423807|NCT00939627|B1|Baseline|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423808|NCT00939627|P3|Participant Flow|Participants Who Did Not Receive Treatment.|Placebo Arm: The protocol was amended and this arm was removed.
423809|NCT00939627|P2|Participant Flow|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423810|NCT00939627|P1|Participant Flow|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility..
423811|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423812|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423813|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423814|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423815|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423816|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423817|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423818|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423819|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423820|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423821|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423858|NCT00939484|B1|Baseline|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
423822|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423823|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
423824|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423825|NCT00939627|E2|Reported Event|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
423826|NCT00939627|E1|Reported Event|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
423827|NCT00939562|B1|Baseline|Entire Study Population|Includes subjects who received a single dose of one 100 mg doxycycline monohydrate tablet (Test) and a single dose of one 100 mg doxycycline carragenate tablet (Reference).
423828|NCT00939562|P2|Participant Flow|Doxycycline Carragenate, Then Doxycycline Monohydrate|Single dose of one 100 mg doxycycline carragenate tablet (Reference) during first period and single dose of one 100 mg doxycycline monohydrate tablet (Test) during the second period.
423829|NCT00939562|P1|Participant Flow|Doxycycline Monohydrate, Then Doxycycline Carragenate|Single dose of one 100 mg doxycycline monohydrate tablet (Test) during first period and single dose of one 100 mg doxycycline carragenate tablet (Reference) during the second period.
423830|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
423831|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
423832|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
423833|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
423834|NCT00939562|E2|Reported Event|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
423835|NCT00939562|E1|Reported Event|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
423836|NCT00939536|B3|Baseline|Total|Total of all reporting groups
423837|NCT00939536|B2|Baseline|Active Comparator|Ambien® 10mg tablets
423838|NCT00939536|B1|Baseline|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423839|NCT00939536|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
423840|NCT00939536|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
423841|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
423842|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423843|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
423844|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423845|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
423846|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423847|NCT00939536|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
423848|NCT00939536|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423849|NCT00939510|B1|Baseline|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
423850|NCT00939510|P1|Participant Flow|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
423851|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
423852|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
423853|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
423854|NCT00939510|E1|Reported Event|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
423855|NCT00939484|B4|Baseline|Total|Total of all reporting groups
423856|NCT00939484|B3|Baseline|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
423857|NCT00939484|B2|Baseline|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
423859|NCT00939484|P3|Participant Flow|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
423860|NCT00939484|P2|Participant Flow|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
423861|NCT00939484|P1|Participant Flow|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
423862|NCT00939484|O1|Outcome|PBTC025B|Adult patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory.
423863|NCT00939484|O1|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
423864|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
423865|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
423866|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
423867|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
423868|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
423869|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
423870|NCT00939484|E3|Reported Event|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
423871|NCT00939484|E2|Reported Event|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
423872|NCT00939484|E1|Reported Event|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
423873|NCT00939471|B1|Baseline|Balloon Device|Balloon catheter dilation of sinus ostia
423874|NCT00939471|P1|Participant Flow|Balloon Device|Balloon catheter dilation of sinus ostia
423875|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423876|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423877|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423878|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423879|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423880|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423881|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423882|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
423883|NCT00939471|E1|Reported Event|Balloon Device|Balloon catheter dilation of sinus ostia
423884|NCT00939393|B3|Baseline|Total|Total of all reporting groups
423885|NCT00939393|B2|Baseline|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423886|NCT00939393|B1|Baseline|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423887|NCT00939393|P2|Participant Flow|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423888|NCT00939393|P1|Participant Flow|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423889|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery (ESS) performed in the operating room (OR) with or without balloon sinus dilation devices.
423890|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery (ESS) performed in physician's office (IO, or In Office) using balloon sinus dilation device.
423891|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423892|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423893|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423894|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423895|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423896|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423897|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423898|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423899|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423900|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
424067|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
423902|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423903|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423904|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423905|NCT00939393|E2|Reported Event|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
423906|NCT00939393|E1|Reported Event|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
423907|NCT00939367|B1|Baseline|All Study Participants|Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets
423908|NCT00939367|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
423909|NCT00939367|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
423910|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
423911|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423912|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
423913|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423914|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
423915|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423916|NCT00939367|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
423917|NCT00939367|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
423918|NCT00939341|B1|Baseline|Symbicort Turbuhaler|160/4.5 µg delivered dose
423919|NCT00939341|P1|Participant Flow|Symbicort Turbuhaler|160/4.5 µg delivered dose
423920|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423921|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423922|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423923|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423924|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423925|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423926|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423927|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423928|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423929|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423930|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423931|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423932|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423933|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423934|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423935|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423936|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
423937|NCT00939341|E1|Reported Event|Symbicort Turbuhaler|160/4.5 µg delivered dose
423938|NCT00939211|B1|Baseline|Overall Number of Baseline Participants|
423939|NCT00939211|P1|Participant Flow|Entire Study Population|
423940|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423941|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423942|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423943|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423944|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423945|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423946|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423947|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423948|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423949|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423950|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423951|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423952|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423953|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423954|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423955|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423956|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423957|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423958|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423959|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423960|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423961|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423962|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423963|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423964|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423965|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423966|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423967|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423968|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423969|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423970|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423971|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423972|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423973|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423974|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423975|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423976|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423977|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423978|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423979|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423980|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423981|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423982|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423983|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423984|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423985|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423986|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423987|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423988|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423989|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423990|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423991|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423992|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423993|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423994|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423995|NCT00939211|E5|Reported Event|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
423996|NCT00939211|E4|Reported Event|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
423997|NCT00939211|E3|Reported Event|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423998|NCT00939211|E2|Reported Event|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
423999|NCT00939211|E1|Reported Event|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
424000|NCT00939185|B1|Baseline|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
424001|NCT00939185|P1|Participant Flow|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
424002|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
424003|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
424004|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
424005|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
424006|NCT00939185|E1|Reported Event|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
424007|NCT00939159|B1|Baseline|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
424008|NCT00939159|P1|Participant Flow|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
424009|NCT00939159|O1|Outcome|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
424010|NCT00939159|E1|Reported Event|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
424011|NCT00939120|B3|Baseline|Total|Total of all reporting groups
424012|NCT00939120|B2|Baseline|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424013|NCT00939120|B1|Baseline|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424014|NCT00939120|P2|Participant Flow|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424015|NCT00939120|P1|Participant Flow|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424016|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424068|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424017|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424018|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424019|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424020|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424021|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424022|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424023|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424024|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424025|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424026|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424027|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424028|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424029|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424030|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424031|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424032|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424033|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424034|NCT00939120|E2|Reported Event|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
424035|NCT00939120|E1|Reported Event|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
424036|NCT00939107|B3|Baseline|Total|Total of all reporting groups
424037|NCT00939107|B2|Baseline|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
424038|NCT00939107|B1|Baseline|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
424039|NCT00939107|P2|Participant Flow|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
424040|NCT00939107|P1|Participant Flow|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
424041|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
424042|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
424043|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
424044|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
424045|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
424046|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
424047|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
424048|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
424049|NCT00939107|E2|Reported Event|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
424050|NCT00939107|E1|Reported Event|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
424051|NCT00939094|B3|Baseline|Total|Total of all reporting groups
424052|NCT00939094|B2|Baseline|2 - Placebo|Placebo, capsule
424053|NCT00939094|B1|Baseline|A - AZD2066|AZD2066, 12 mg capsule
424054|NCT00939094|P2|Participant Flow|2 - Placebo|Placebo, capsule
424055|NCT00939094|P1|Participant Flow|A - AZD2066|AZD2066, 12 mg capsule
424056|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424057|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
424058|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424059|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
424060|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424061|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
424062|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424063|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
424064|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424065|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
424066|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424069|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
424070|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
424071|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
424072|NCT00939094|E2|Reported Event|2 - Placebo|Placebo, capsule
424073|NCT00939094|E1|Reported Event|A - AZD2066|AZD2066, 12 mg capsule
424074|NCT00939055|B3|Baseline|Total|Total of all reporting groups
424075|NCT00939055|B2|Baseline|Sham Procedure|"No intervention~Sham procedure: False procedure"
424076|NCT00939055|B1|Baseline|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
424077|NCT00939055|P2|Participant Flow|Sham Procedure|"No intervention~Sham procedure: False procedure"
424078|NCT00939055|P1|Participant Flow|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
424079|NCT00939055|O2|Outcome|Sham Procedure|"No intervention~Sham procedure: False procedure"
424080|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
424081|NCT00939055|O2|Outcome|Sham|No intervention
424082|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
424083|NCT00939055|E2|Reported Event|Sham|No intervention
424084|NCT00939055|E1|Reported Event|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
424085|NCT00939029|B3|Baseline|Total|Total of all reporting groups
424086|NCT00939029|B2|Baseline|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
424087|NCT00939029|B1|Baseline|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
424088|NCT00939029|P2|Participant Flow|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
424089|NCT00939029|P1|Participant Flow|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
424090|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
424091|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
424092|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
424093|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
424094|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
424095|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
424096|NCT00939029|E2|Reported Event|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
424097|NCT00939029|E1|Reported Event|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
424098|NCT00939003|B3|Baseline|Total|Total of all reporting groups
424099|NCT00939003|B2|Baseline|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424100|NCT00939003|B1|Baseline|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424101|NCT00939003|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424102|NCT00939003|P1|Participant Flow|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424103|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424104|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424105|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424106|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424158|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
427380|NCT00930761|O2|Outcome|Music Therapy|
424107|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424108|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
424109|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424110|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424111|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424112|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424113|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424114|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424115|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424116|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424117|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424118|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424119|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424120|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424121|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424122|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424123|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424124|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424125|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424126|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424127|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424128|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424129|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424130|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424131|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
424132|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
424133|NCT00939003|E3|Reported Event|Any Adalimumab|Participants who received any dose of adalimumab during the 12-week double-blind period or during the 144-week open-label period.
424134|NCT00939003|E2|Reported Event|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period.
424135|NCT00939003|E1|Reported Event|Double-blind Placebo|Participants received placebo every other week for 12 weeks during the double-blind period.
424136|NCT00938964|B3|Baseline|Total|Total of all reporting groups
424137|NCT00938964|B2|Baseline|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424138|NCT00938964|B1|Baseline|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424139|NCT00938964|P2|Participant Flow|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424140|NCT00938964|P1|Participant Flow|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424141|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424142|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424143|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424144|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424145|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424146|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424147|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424148|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424149|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424150|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424151|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424152|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424153|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424154|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424155|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424156|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424157|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424228|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424159|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424160|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424161|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424162|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424163|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424164|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424165|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424166|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424167|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424168|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424169|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424170|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424171|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424172|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424173|NCT00938964|O2|Outcome|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424174|NCT00938964|O1|Outcome|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424175|NCT00938964|E2|Reported Event|Placebo|"Normal saline infusion for 48 hours~Placebo: Lidocaine versus placebo infusion for 48 hours"
424176|NCT00938964|E1|Reported Event|Lidocaine|"Lidocaine infusion for 48 hours~Lidocaine: Lidocaine versus placebo infusion for 48 hours"
424177|NCT00938886|B3|Baseline|Total|Total of all reporting groups
424178|NCT00938886|B2|Baseline|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
424179|NCT00938886|B1|Baseline|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
424180|NCT00938886|P2|Participant Flow|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
424181|NCT00938886|P1|Participant Flow|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
424182|NCT00938886|O2|Outcome|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
424183|NCT00938886|O1|Outcome|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
424184|NCT00938886|O2|Outcome|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
424185|NCT00938886|O1|Outcome|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
424186|NCT00938886|E2|Reported Event|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
424187|NCT00938886|E1|Reported Event|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
424188|NCT00938860|B3|Baseline|Total|Total of all reporting groups
424189|NCT00938860|B2|Baseline|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424190|NCT00938860|B1|Baseline|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424191|NCT00938860|P2|Participant Flow|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424192|NCT00938860|P1|Participant Flow|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424193|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424194|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424195|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424196|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424197|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424198|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424229|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424230|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424199|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424200|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424201|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424202|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424203|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424204|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424205|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424206|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424207|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424208|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424209|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424210|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424211|NCT00938860|E2|Reported Event|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
424212|NCT00938860|E1|Reported Event|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
424213|NCT00938782|B3|Baseline|Total|Total of all reporting groups
424214|NCT00938782|B2|Baseline|2 - CONTROL Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group)"
424215|NCT00938782|B1|Baseline|1 - SEDLine™ Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group)."
424216|NCT00938782|P2|Participant Flow|2- Control Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
424217|NCT00938782|P1|Participant Flow|1 - SEDLine™ Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
424218|NCT00938782|O2|Outcome|2 - Control Group|Patient groups randomized to active monitoring versus blinded monitoring. This group had teh clinician blinded to output of the Sedline monitor.
424219|NCT00938782|O1|Outcome|1 - Sedline Group|Patient group randomized to active monitoring with Sedline monitor.
424220|NCT00938782|E2|Reported Event|Group 2 - Control Group|Patient groups randomized to monitoring with blinded data not used to titrate anesthesia.
424221|NCT00938782|E1|Reported Event|1 - SEDLine Group|Patient groups randomized to active monitoring. This group had Sedline monitor used to titrate anesthesia.
424222|NCT00938717|B3|Baseline|Total|Total of all reporting groups
424223|NCT00938717|B2|Baseline|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424224|NCT00938717|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
424225|NCT00938717|P2|Participant Flow|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424226|NCT00938717|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
424227|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424231|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424232|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424233|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424234|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424235|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424236|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424237|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424238|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424239|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424240|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424241|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424242|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424243|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424244|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424245|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424246|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424247|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424248|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424249|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424250|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424251|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424252|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424253|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424254|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
424255|NCT00938717|E2|Reported Event|Linaclotide|Linaclotide 290μg, oral administration, once per day.
424256|NCT00938717|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
424257|NCT00938704|B3|Baseline|Total|Total of all reporting groups
424258|NCT00938704|B2|Baseline|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424259|NCT00938704|B1|Baseline|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424260|NCT00938704|P2|Participant Flow|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424261|NCT00938704|P1|Participant Flow|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424262|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424263|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424264|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424265|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424266|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424267|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424268|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424269|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424270|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424271|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424272|NCT00938704|E2|Reported Event|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
424273|NCT00938704|E1|Reported Event|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
424274|NCT00938639|B3|Baseline|Total|Total of all reporting groups
424275|NCT00938639|B2|Baseline|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424276|NCT00938639|B1|Baseline|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424277|NCT00938639|P2|Participant Flow|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424278|NCT00938639|P1|Participant Flow|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424279|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424280|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424281|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424282|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424283|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424284|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424285|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424286|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
425362|NCT00936117|E1|Reported Event|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
424287|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424288|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424289|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424290|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424291|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424292|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424293|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424294|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424295|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424296|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424297|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424298|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424299|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424300|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424301|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424302|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424303|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424304|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424305|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424306|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424307|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424308|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424309|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424310|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424311|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424312|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424313|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424314|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424315|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424316|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424317|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424318|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424319|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424320|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424321|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424322|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424323|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424324|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
427381|NCT00930761|O1|Outcome|Control|
424325|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424326|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424327|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424328|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424329|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424330|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424331|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424332|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424333|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424334|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424335|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424336|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424337|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424338|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424339|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424340|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424341|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424342|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424343|NCT00938639|E2|Reported Event|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424344|NCT00938639|E1|Reported Event|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
424345|NCT00938548|B3|Baseline|Total|Total of all reporting groups
424346|NCT00938548|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
424347|NCT00938548|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
424348|NCT00938548|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
424349|NCT00938548|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
424350|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
424351|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
424352|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
424353|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
424354|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
424355|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
424356|NCT00938548|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
424357|NCT00938548|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
424358|NCT00938470|B3|Baseline|Total|Total of all reporting groups
424359|NCT00938470|B2|Baseline|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424360|NCT00938470|B1|Baseline|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424361|NCT00938470|P2|Participant Flow|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424376|NCT00938457|P1|Participant Flow|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
425363|NCT00936065|B4|Baseline|Total|Total of all reporting groups
424362|NCT00938470|P1|Participant Flow|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424363|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424364|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424365|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424366|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424367|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424368|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424369|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424370|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424371|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424372|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424373|NCT00938470|E2|Reported Event|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
424374|NCT00938470|E1|Reported Event|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
424375|NCT00938457|B1|Baseline|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
427382|NCT00930761|E2|Reported Event|Music Therapy|
424377|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424378|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424379|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424380|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424381|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424382|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424383|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424384|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424385|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424386|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424387|NCT00938457|E1|Reported Event|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
424388|NCT00938431|B4|Baseline|Total Title|
424389|NCT00938431|B3|Baseline|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424390|NCT00938431|B2|Baseline|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424391|NCT00938431|B1|Baseline|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424392|NCT00938431|P3|Participant Flow|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424393|NCT00938431|P2|Participant Flow|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424394|NCT00938431|P1|Participant Flow|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424395|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424396|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424397|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424398|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424399|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424400|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424401|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424402|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
424403|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424404|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424405|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424406|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424407|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424408|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424409|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424410|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424411|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424412|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424413|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424414|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424415|NCT00938431|E3|Reported Event|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424416|NCT00938431|E2|Reported Event|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424417|NCT00938431|E1|Reported Event|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
424418|NCT00938392|B3|Baseline|Total|Total of all reporting groups
424419|NCT00938392|B2|Baseline|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424420|NCT00938392|B1|Baseline|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424421|NCT00938392|P2|Participant Flow|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424422|NCT00938392|P1|Participant Flow|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424423|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424424|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424425|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424426|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424427|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424428|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424429|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424430|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424431|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424432|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424433|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424434|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424435|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424436|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424437|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424438|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424439|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424440|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424441|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424442|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424443|NCT00938392|E2|Reported Event|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
424444|NCT00938392|E1|Reported Event|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
424445|NCT00938366|B3|Baseline|Total|Total of all reporting groups
424446|NCT00938366|B2|Baseline|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
424447|NCT00938366|B1|Baseline|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
424448|NCT00938366|P2|Participant Flow|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
424449|NCT00938366|P1|Participant Flow|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
424450|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424451|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424452|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424453|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424454|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424455|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424456|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424457|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424458|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424459|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424460|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424461|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424462|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424463|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424464|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424465|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424466|NCT00938366|E2|Reported Event|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
424467|NCT00938366|E1|Reported Event|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
424468|NCT00938327|B1|Baseline|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
424469|NCT00938327|P1|Participant Flow|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
424470|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
424471|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
424472|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
424473|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
424474|NCT00938327|E1|Reported Event|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
424475|NCT00938314|B5|Baseline|Total|Total of all reporting groups
424476|NCT00938314|B4|Baseline|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424477|NCT00938314|B3|Baseline|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424478|NCT00938314|B2|Baseline|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424479|NCT00938314|B1|Baseline|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424480|NCT00938314|P4|Participant Flow|Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424481|NCT00938314|P3|Participant Flow|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424482|NCT00938314|P2|Participant Flow|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424483|NCT00938314|P1|Participant Flow|NTx®-265 Low Dose|human chorionic gonadotropin (hCG) 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
427383|NCT00930761|E1|Reported Event|Control|
424484|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424485|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424486|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424487|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424488|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424489|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424490|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424491|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424492|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424493|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424494|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424495|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424496|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424497|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424498|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424499|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424500|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424501|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424502|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424503|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424504|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424505|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424506|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424507|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424508|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424509|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424510|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424511|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424512|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424513|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424514|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424515|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424516|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424517|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424518|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424519|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424520|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424521|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
430617|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
424522|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424523|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424524|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424525|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424526|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424527|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424528|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424529|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424530|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424531|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424532|NCT00938314|E4|Reported Event|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
424533|NCT00938314|E3|Reported Event|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
424534|NCT00938314|E2|Reported Event|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
424535|NCT00938314|E1|Reported Event|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
424536|NCT00938041|B1|Baseline|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424537|NCT00938041|P1|Participant Flow|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424538|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424539|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424540|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
425364|NCT00936065|B3|Baseline|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
424541|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424542|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424543|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424544|NCT00938041|E1|Reported Event|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
424545|NCT00938015|B1|Baseline|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424546|NCT00938015|P1|Participant Flow|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424547|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424548|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424549|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424550|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424551|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424552|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424553|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424554|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424555|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424556|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424557|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424558|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424559|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424560|NCT00938015|E1|Reported Event|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
424561|NCT00937950|B1|Baseline|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424562|NCT00937950|P1|Participant Flow|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424599|NCT00937768|B2|Baseline|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
424563|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424564|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424565|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424566|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424567|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424568|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424569|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424570|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424571|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424572|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424573|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424574|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424575|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424576|NCT00937950|E1|Reported Event|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
424577|NCT00937937|B1|Baseline|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
424578|NCT00937937|P1|Participant Flow|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
424579|NCT00937937|O1|Outcome|Dinaciclib|
424580|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
424581|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
424582|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
424583|NCT00937937|E1|Reported Event|SCH 727965|
424584|NCT00937833|B3|Baseline|Total|Total of all reporting groups
424585|NCT00937833|B2|Baseline|Control|No sling placed at the time of prostatectomy
424586|NCT00937833|B1|Baseline|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
424587|NCT00937833|P2|Participant Flow|Control|No sling placed at the time of prostatectomy
424588|NCT00937833|P1|Participant Flow|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
424589|NCT00937833|O2|Outcome|Control|No sling placed at the time of prostatectomy
424590|NCT00937833|O1|Outcome|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
424591|NCT00937833|E2|Reported Event|Control|No sling placed at the time of prostatectomy
424592|NCT00937833|E1|Reported Event|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
424593|NCT00937794|B1|Baseline|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
424594|NCT00937794|P1|Participant Flow|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
424595|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
424596|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
424597|NCT00937794|E1|Reported Event|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
424598|NCT00937768|B3|Baseline|Total|Total of all reporting groups
430618|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
424600|NCT00937768|B1|Baseline|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
424601|NCT00937768|P2|Participant Flow|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
424602|NCT00937768|P1|Participant Flow|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
424603|NCT00937768|O2|Outcome|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
424604|NCT00937768|O1|Outcome|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
424605|NCT00937768|E2|Reported Event|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
424606|NCT00937768|E1|Reported Event|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
424607|NCT00937560|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
424608|NCT00937560|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of each cycle, paclitaxel 80 milligrams per square meters of body surface (mg/m^2) IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an area under the curve (AUC) of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (milligrams [mg] equals [=] [glomerular filtration rate (GFR) + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
424609|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
424610|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
424611|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
424612|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
424613|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period.
424653|NCT00937521|B5|Baseline|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424654|NCT00937521|B4|Baseline|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
425190|NCT00936897|E2|Reported Event|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
424614|NCT00937560|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion. Paclitaxel: Paclitaxel was supplied locally in commercial batches. Carboplatin: Carboplatin was supplied locally in commercial batches.
424615|NCT00937547|B4|Baseline|Total|Total of all reporting groups
424616|NCT00937547|B3|Baseline|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
424617|NCT00937547|B2|Baseline|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
424618|NCT00937547|B1|Baseline|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
424619|NCT00937547|P3|Participant Flow|Cervical Intraepithelial Neoplasia 3|patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
424620|NCT00937547|P2|Participant Flow|Cervical Intraepithelial Neoplasia 2|patients with histological diagnosis of cervical intraepithelial neoplasia grade 2
424621|NCT00937547|P1|Participant Flow|Invasive Cervical Cancer|patients with histologic diagnosis invasive cervical cancer.
424622|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424623|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424624|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424625|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424626|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424627|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424628|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424629|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424630|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424631|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424632|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424633|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424634|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424635|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424636|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424637|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424638|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424639|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424640|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424641|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424642|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424643|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
424644|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
424645|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
424646|NCT00937547|E3|Reported Event|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
424647|NCT00937547|E2|Reported Event|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
424648|NCT00937547|E1|Reported Event|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
424649|NCT00937521|B9|Baseline|Total|Total of all reporting groups
424650|NCT00937521|B8|Baseline|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424651|NCT00937521|B7|Baseline|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424652|NCT00937521|B6|Baseline|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424655|NCT00937521|B3|Baseline|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424656|NCT00937521|B2|Baseline|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424657|NCT00937521|B1|Baseline|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424658|NCT00937521|P8|Participant Flow|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424659|NCT00937521|P7|Participant Flow|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424660|NCT00937521|P6|Participant Flow|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424661|NCT00937521|P5|Participant Flow|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424662|NCT00937521|P4|Participant Flow|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424663|NCT00937521|P3|Participant Flow|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424664|NCT00937521|P2|Participant Flow|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424665|NCT00937521|P1|Participant Flow|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424666|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424667|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424668|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424669|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424670|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424671|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424672|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424673|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424674|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424675|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424676|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424677|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424678|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424679|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424680|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424681|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424682|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424683|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424684|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424685|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424686|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424687|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424688|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424689|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424690|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424691|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424692|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424693|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424694|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424695|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424696|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424697|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424698|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424699|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424700|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424701|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424702|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424703|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424704|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424705|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424706|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424707|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424708|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
425191|NCT00936897|E1|Reported Event|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
424709|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
424710|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424711|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424712|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424713|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424714|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
424715|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424716|NCT00937521|O2|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424717|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424718|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424719|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424720|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424721|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424722|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424723|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424724|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424725|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424726|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424727|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424728|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424729|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424730|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
424731|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424732|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424733|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
424734|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424735|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
425192|NCT00936741|B1|Baseline|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
424736|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424737|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424738|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424739|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424740|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424741|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424742|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424743|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424744|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424745|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424746|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
424747|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
424748|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424749|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424750|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424751|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424752|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424753|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
424754|NCT00937521|E16|Reported Event|Par+B+OMV (Group VIII) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
424755|NCT00937521|E15|Reported Event|MenC (Group VII) Booster Phase|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to include Booster Phase."
424756|NCT00937521|E14|Reported Event|PH2 B+OMV (Group VI) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
424757|NCT00937521|E13|Reported Event|½ (B+OMV) (Group V) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
424758|NCT00937521|E12|Reported Event|B (Group IV) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
424759|NCT00937521|E11|Reported Event|B+1/4 OMV (Group III) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
424760|NCT00937521|E10|Reported Event|B+½ OMV (Group II) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
424761|NCT00937521|E9|Reported Event|B+OMV (Group I) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
425606|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
424762|NCT00937521|E8|Reported Event|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
424763|NCT00937521|E7|Reported Event|MenC (Group VII)|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
424764|NCT00937521|E6|Reported Event|PH2 B+OMV (Group VI)|"SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
424765|NCT00937521|E5|Reported Event|½ (B+OMV) (Group V)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
424766|NCT00937521|E4|Reported Event|B (Group IV)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting.."
424767|NCT00937521|E3|Reported Event|B+1/4 OMV (Group III)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
424768|NCT00937521|E2|Reported Event|B+½ OMV (Group II)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
424769|NCT00937521|E1|Reported Event|B+OMV (Group I)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
424770|NCT00937495|B1|Baseline|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
424771|NCT00937495|P1|Participant Flow|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
424772|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
424773|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
424774|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
424775|NCT00937495|E1|Reported Event|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
424776|NCT00937391|B3|Baseline|Total|Total of all reporting groups
424777|NCT00937391|B2|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) – Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424778|NCT00937391|B1|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424779|NCT00937391|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-6661)|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424780|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424781|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424782|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424783|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424784|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424785|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424786|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424787|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424788|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424789|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
424790|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424791|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424792|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
424793|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424794|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424795|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424796|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424797|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424798|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424799|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424800|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424801|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424802|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
424803|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424804|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424805|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
424806|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424807|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
424808|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424809|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424810|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
424811|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424812|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
424813|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424814|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424815|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
425077|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
424816|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424817|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424818|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424819|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424820|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424821|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424822|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424823|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424824|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424825|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424826|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
424827|NCT00937391|E2|Reported Event|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
424828|NCT00937391|E1|Reported Event|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
424829|NCT00937326|B6|Baseline|Total|Total of all reporting groups
424830|NCT00937326|B5|Baseline|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424831|NCT00937326|B4|Baseline|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424832|NCT00937326|B3|Baseline|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424833|NCT00937326|B2|Baseline|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424834|NCT00937326|B1|Baseline|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424835|NCT00937326|P5|Participant Flow|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425101|NCT00937105|P2|Participant Flow|Lotrafilcon A Lenses and Renu Multiplus|
425102|NCT00937105|P1|Participant Flow|Lotrafilcon A Lenses and Clear Care|
424836|NCT00937326|P4|Participant Flow|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424837|NCT00937326|P3|Participant Flow|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424838|NCT00937326|P2|Participant Flow|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424839|NCT00937326|P1|Participant Flow|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 minutes (min) following the start of meal consumption with 1 to 2 glasses of water.
424840|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424841|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424842|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424843|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424844|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424845|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424846|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424847|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424848|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424849|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424850|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424851|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424852|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424853|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424854|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 minutes following the start of meal consumption with 1 to 2 glasses of water.
424855|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425103|NCT00937105|O2|Outcome|Participants With no CNS Bioburden on Lid Margins|
425104|NCT00937105|O1|Outcome|Participants With CNS Bioburden on Lid Margins|
424856|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424857|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424858|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424859|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424860|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424861|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424862|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424863|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424864|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424865|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424866|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424867|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424868|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424869|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424870|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424871|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424872|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424873|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424874|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424875|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425105|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lid Margins|
425106|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lid Margins|
424876|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424877|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424878|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424879|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424880|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424881|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424882|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424883|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424884|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424885|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424886|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424887|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424888|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424889|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424890|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424891|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424892|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424893|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424894|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424895|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425107|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lens Cases|
425108|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lens Cases|
424896|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424897|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424898|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424899|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424900|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424901|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424902|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424903|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424904|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424905|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424906|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424907|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424908|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424909|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424910|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424911|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424912|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424913|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424914|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424915|NCT00937326|O4|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425109|NCT00937105|O2|Outcome|Participants Without Corneal Staining|
425110|NCT00937105|O1|Outcome|Participants With Corneal Staining|
424916|NCT00937326|O3|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424917|NCT00937326|O2|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424918|NCT00937326|O1|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424919|NCT00937326|O4|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424920|NCT00937326|O3|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424921|NCT00937326|O2|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424922|NCT00937326|O1|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424923|NCT00937326|O4|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424924|NCT00937326|O3|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424925|NCT00937326|O2|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424926|NCT00937326|O1|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424927|NCT00937326|O4|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424928|NCT00937326|O3|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424929|NCT00937326|O2|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424930|NCT00937326|O1|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424931|NCT00937326|O4|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424932|NCT00937326|O3|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424933|NCT00937326|O2|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424934|NCT00937326|O1|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424935|NCT00937326|O4|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425111|NCT00937105|O2|Outcome|Participants Without Microbial Bioburden on Lenses|
425112|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lenses|
424936|NCT00937326|O3|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424937|NCT00937326|O2|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424938|NCT00937326|O1|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424939|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424940|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424941|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424942|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424943|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424944|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424945|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424946|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424947|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424948|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424949|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424950|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424951|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424952|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424953|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424954|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424955|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425113|NCT00937105|O2|Outcome|Lotrafilcon A Lenses and Clear Care|
425114|NCT00937105|O1|Outcome|Lotrafilcon A Lenses and Renu|
424956|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424957|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424958|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424959|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424960|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424961|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424962|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424963|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424964|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424965|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424966|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424967|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424968|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424969|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424970|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424971|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424972|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424973|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424974|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424975|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425115|NCT00937105|E1|Reported Event|Entire Cohort of Lotrafilcon A Users|
425116|NCT00937040|B3|Baseline|Total|Total of all reporting groups
424976|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424977|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424978|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424979|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424980|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424981|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424982|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424983|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424984|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424985|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424986|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424987|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424988|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424989|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424990|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424991|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424992|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424993|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424994|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424995|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425117|NCT00937040|B2|Baseline|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
424996|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424997|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424998|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
424999|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425000|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425001|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425002|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425003|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425004|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425005|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425006|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425007|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425008|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425009|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425010|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425011|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425012|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425013|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425014|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425015|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425118|NCT00937040|B1|Baseline|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425703|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
425016|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425017|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425018|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425019|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425020|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425021|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425022|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425023|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425024|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425025|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425026|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425027|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425028|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425029|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425030|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425031|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425032|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425033|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425034|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425035|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425119|NCT00937040|P2|Participant Flow|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425036|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425037|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425038|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425039|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425040|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425041|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425042|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425043|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425044|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425045|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425046|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425047|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425048|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425049|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425050|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425051|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425052|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425053|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425054|NCT00937326|O5|Outcome|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425055|NCT00937326|O4|Outcome|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425120|NCT00937040|P1|Participant Flow|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425704|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
425056|NCT00937326|O3|Outcome|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425057|NCT00937326|O2|Outcome|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425058|NCT00937326|O1|Outcome|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425059|NCT00937326|E5|Reported Event|SRT2104 2.0 g/Day|Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425060|NCT00937326|E4|Reported Event|SRT2104 1.0 g/Day|Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425061|NCT00937326|E3|Reported Event|SRT2104 0.5 g/Day|Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425062|NCT00937326|E2|Reported Event|SRT2104 0.25 g/Day|Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425063|NCT00937326|E1|Reported Event|Placebo|Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water.
425064|NCT00937235|B3|Baseline|Total|Total of all reporting groups
425065|NCT00937235|B2|Baseline|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425066|NCT00937235|B1|Baseline|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425067|NCT00937235|P2|Participant Flow|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425068|NCT00937235|P1|Participant Flow|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425069|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425070|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425071|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425072|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425073|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425074|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425075|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425076|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425078|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425079|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425080|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425081|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425082|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425083|NCT00937235|O2|Outcome|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425084|NCT00937235|O1|Outcome|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425085|NCT00937235|E2|Reported Event|Varenicline|"Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation"
425086|NCT00937235|E1|Reported Event|Integrated Treatment|"Prolonged Exposure + Varenicline + Medication Management Counseling~Varenicline: 1 mg tablets, orally, twice daily x 12 weeks~Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation~Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders"
425087|NCT00937157|B1|Baseline|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
425088|NCT00937157|P1|Participant Flow|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
425089|NCT00937157|O1|Outcome|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
425090|NCT00937157|E1|Reported Event|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
425091|NCT00937118|B1|Baseline|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
425092|NCT00937118|P1|Participant Flow|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
425093|NCT00937118|O4|Outcome|Fascial Closure|Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure
425094|NCT00937118|O3|Outcome|Damage Control|Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique
425095|NCT00937118|O2|Outcome|Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques
425096|NCT00937118|O1|Outcome|No Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques
425097|NCT00937118|E1|Reported Event|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
425098|NCT00937105|B3|Baseline|Total|Total of all reporting groups
425099|NCT00937105|B2|Baseline|Lotrafilcon A and Clear Care|
425100|NCT00937105|B1|Baseline|Lotrafilcon A and Renu|
425121|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425122|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425123|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425124|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425125|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425126|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425127|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425128|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425129|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425130|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425131|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425132|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425133|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425134|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425135|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425136|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425137|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425138|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425139|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425140|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425141|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425142|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425143|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425144|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425145|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425146|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425147|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425148|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425149|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425150|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425151|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425152|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425153|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425154|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425155|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425156|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425157|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425158|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425159|NCT00937040|E2|Reported Event|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
425160|NCT00937040|E1|Reported Event|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
425161|NCT00936975|B1|Baseline|Overall|Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline
425162|NCT00936975|P1|Participant Flow|Overall|Participants on the parent study (“Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer”) receiving 100mg PO QD Dasatinib
425163|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
425705|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
425164|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
425165|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
425166|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
425167|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
425168|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
425169|NCT00936975|E1|Reported Event|Overall|Participants receiving 100mg PO QD Dasatinib
425170|NCT00936910|B1|Baseline|Treated Patients|Patients enrolled had intestinal insufficiency (including intestinal transplantation) and/or the presence of long term central venous access, and one or more positive cultures for yeast attributed to the central line. Patients were excluded if they hypotension at the time of enrollment or need for ICU support.
425171|NCT00936910|P1|Participant Flow|Antifungal Lock-treated Patients|"This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections~After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
425172|NCT00936910|O1|Outcome|Antifungal Lock-treated Patients|"This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections~After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
425173|NCT00936910|O1|Outcome|Antifungal Lock-treated Patients|"Intestinal failure and other patients with poor IV access and central line fungal-related infections~After enrollment, antifungal therapy will be instituted consisting of both IV systemic and antifungal lock therapy. Systemic therapy will be Ambisome administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing up to 2.3 ml of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
425174|NCT00936910|O1|Outcome|Antifungal Lock-treated Patients|"This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections~After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
425175|NCT00936910|O1|Outcome|Antifungal Lock-treated Patients|"This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections~After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
425176|NCT00936910|E1|Reported Event|Antifungal Lock-treated Patients|"Intestinal failure and other patients with poor IV access and central line fungal-related infections~After enrollment, antifungal therapy will be instituted consisting of both IV systemic and antifungal lock therapy. Systemic therapy will be Ambisome administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing up to 2.3 ml (maximum catheter size) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days."
425177|NCT00936897|B3|Baseline|Total|Total of all reporting groups
425178|NCT00936897|B2|Baseline|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
425179|NCT00936897|B1|Baseline|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
425180|NCT00936897|P2|Participant Flow|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
425181|NCT00936897|P1|Participant Flow|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
425182|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
425183|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
425184|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
425185|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
425186|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
425187|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
425188|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
425189|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
425193|NCT00936741|P1|Participant Flow|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
425194|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
425195|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
425196|NCT00936741|E1|Reported Event|Mifepristone 300 to 1200 mg Daily|mifepristone at doses from 300 mg/day to 1200 mg/day
425197|NCT00936715|B1|Baseline|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
425198|NCT00936715|P1|Participant Flow|FTC/TDF|Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®) (200/300 mg) fixed dose combination (FDC) tablet administered once daily for up to 240 weeks.
425199|NCT00936715|O1|Outcome|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
425200|NCT00936715|E1|Reported Event|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered orally once daily for up to 240 weeks
425201|NCT00936702|B1|Baseline|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425202|NCT00936702|P1|Participant Flow|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425203|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425204|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425205|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425206|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425207|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425208|NCT00936702|E1|Reported Event|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
425209|NCT00936663|B3|Baseline|Total|Total of all reporting groups
425210|NCT00936663|B2|Baseline|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425211|NCT00936663|B1|Baseline|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425212|NCT00936663|P2|Participant Flow|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425213|NCT00936663|P1|Participant Flow|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425214|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425215|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425216|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425217|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425218|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425219|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425220|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425221|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425281|NCT00936377|P1|Participant Flow|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425222|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425223|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425224|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425225|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425226|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425227|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425228|NCT00936663|O2|Outcome|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425229|NCT00936663|O1|Outcome|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425230|NCT00936663|E2|Reported Event|Placebo|"placebo~Placebo: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425231|NCT00936663|E1|Reported Event|Sitagliptin 100 mg Daily|"sitagliptin 100 mg daily~Sitagliptin: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis."
425232|NCT00936598|B3|Baseline|Total|Total of all reporting groups
425233|NCT00936598|B2|Baseline|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425234|NCT00936598|B1|Baseline|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425235|NCT00936598|P2|Participant Flow|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425236|NCT00936598|P1|Participant Flow|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425237|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425238|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425239|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425240|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425241|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425282|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425706|NCT00935064|E2|Reported Event|Placebo|Once daily, for 6 weeks
425242|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425243|NCT00936598|E2|Reported Event|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425244|NCT00936598|E1|Reported Event|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
425245|NCT00936585|B1|Baseline|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
425246|NCT00936585|P1|Participant Flow|Immunologic Monitoring|All patients who were enrolled in the main study participated in the NIH sub study and underwent a colonoscopy and blood draw for research specimens for immunologic monitoring before and after study drug administration
425247|NCT00936585|O1|Outcome|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
425248|NCT00936585|E1|Reported Event|Colonoscopy|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
425249|NCT00936481|B3|Baseline|Total|Total of all reporting groups
425250|NCT00936481|B2|Baseline|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
425251|NCT00936481|B1|Baseline|Healthy Controls|18 years or older with body mass index between 25-45
425252|NCT00936481|P2|Participant Flow|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
425253|NCT00936481|P1|Participant Flow|Healthy Controls|18 years or older with body mass index between 25-45
425254|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
425255|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
425256|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
425257|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
425258|NCT00936481|E2|Reported Event|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
425259|NCT00936481|E1|Reported Event|Healthy Controls|18 years or older with body mass index between 25-45
425260|NCT00936455|B3|Baseline|Total|Total of all reporting groups
425261|NCT00936455|B2|Baseline|Telephone|Telephone evaluated patients
425262|NCT00936455|B1|Baseline|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
425263|NCT00936455|P2|Participant Flow|Telephone|Telephone evaluated patients
425264|NCT00936455|P1|Participant Flow|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
425265|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 12 months after index event in telephone group
425266|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 12 months after index event in telemedicine group
425267|NCT00936455|O2|Outcome|Telephone|Assessing number of recurrent strokes by 12 months
425268|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)
425269|NCT00936455|O2|Outcome|Telephone|Recurrent stroke at 6 months in each group
425270|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)
425271|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
425272|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group
425273|NCT00936455|E2|Reported Event|Telephone|Telephone evaluated patients
425274|NCT00936455|E1|Reported Event|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
425275|NCT00936377|B4|Baseline|Total|Total of all reporting groups
425276|NCT00936377|B3|Baseline|Placebo|"Normal saline~Placebo: Normal saline for five days."
425277|NCT00936377|B2|Baseline|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425278|NCT00936377|B1|Baseline|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425279|NCT00936377|P3|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline for five days."
425280|NCT00936377|P2|Participant Flow|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425360|NCT00936117|O2|Outcome|Posaconazole (Males)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
425283|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425284|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425285|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425286|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425287|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425288|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425289|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425290|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425291|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425292|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425293|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425294|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425295|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425296|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425297|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425298|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425299|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425300|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425301|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425302|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425303|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
425304|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425305|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425306|NCT00936377|E3|Reported Event|Placebo|"Normal saline~Placebo: Normal saline for five days."
425307|NCT00936377|E2|Reported Event|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425308|NCT00936377|E1|Reported Event|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
425309|NCT00936351|B3|Baseline|Total|Total of all reporting groups
425310|NCT00936351|B2|Baseline|Arm 2|"Support Group~Support Group (control): A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion."
425311|NCT00936351|B1|Baseline|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment."
425312|NCT00936351|P2|Participant Flow|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
425313|NCT00936351|P1|Participant Flow|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
425361|NCT00936117|O1|Outcome|Posaconazole (Females)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
425314|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
425315|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
425316|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
425317|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
425318|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
425319|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
425320|NCT00936351|E2|Reported Event|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
425321|NCT00936351|E1|Reported Event|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
425322|NCT00936221|B3|Baseline|Total|Total of all reporting groups
425323|NCT00936221|B2|Baseline|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
425324|NCT00936221|B1|Baseline|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
425325|NCT00936221|P2|Participant Flow|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
425326|NCT00936221|P1|Participant Flow|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
425327|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
425328|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
425329|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
425330|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
425331|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
425332|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
425333|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
425334|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
425335|NCT00936221|E2|Reported Event|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
425336|NCT00936221|E1|Reported Event|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
425337|NCT00936208|B3|Baseline|Total|Total of all reporting groups
425338|NCT00936208|B2|Baseline|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425339|NCT00936208|B1|Baseline|Micardis 80mg|One tablet of Micardis 80mg per day
425340|NCT00936208|P2|Participant Flow|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425341|NCT00936208|P1|Participant Flow|Micardis 80mg|One tablet of Micardis 80mg per day
425342|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425343|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
425344|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425345|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
425346|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425347|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
425348|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425349|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
425350|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425351|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
425352|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425353|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
425354|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425355|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
425356|NCT00936208|E2|Reported Event|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
425357|NCT00936208|E1|Reported Event|Micardis 80mg|One tablet of Micardis 80mg per day
425358|NCT00936117|B1|Baseline|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
425359|NCT00936117|P1|Participant Flow|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
430619|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
425365|NCT00936065|B2|Baseline|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425366|NCT00936065|B1|Baseline|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425367|NCT00936065|P3|Participant Flow|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425368|NCT00936065|P2|Participant Flow|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425369|NCT00936065|P1|Participant Flow|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425370|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425371|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425372|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425373|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425374|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425375|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425376|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425377|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425378|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425379|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425380|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425381|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425382|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425383|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425384|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425385|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425386|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425387|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425388|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425389|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425390|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425391|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425392|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425393|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425394|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425395|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425396|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425397|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425398|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425399|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425400|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425401|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425402|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425403|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425404|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425405|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425406|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425407|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425408|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425409|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425410|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425411|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425412|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425413|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425414|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425415|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425416|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425417|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425418|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425419|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425420|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425421|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425422|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425423|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425424|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425425|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425426|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425427|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425428|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425429|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425430|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425431|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425432|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425433|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425434|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425435|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425436|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425437|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425438|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425439|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425440|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425441|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425442|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425443|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425444|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425445|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425446|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425447|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425448|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425449|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425450|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425451|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425452|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425453|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425454|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425455|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425456|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425457|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425458|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425459|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425460|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425461|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425462|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425463|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425464|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425465|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425466|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425467|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425468|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425469|NCT00936065|E3|Reported Event|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
425470|NCT00936065|E2|Reported Event|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
425471|NCT00936065|E1|Reported Event|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
425472|NCT00935883|B3|Baseline|Total|Total of all reporting groups
425473|NCT00935883|B2|Baseline|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425474|NCT00935883|B1|Baseline|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425475|NCT00935883|P2|Participant Flow|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425476|NCT00935883|P1|Participant Flow|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425477|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425478|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425479|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425480|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425505|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425605|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425481|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425482|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425483|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425484|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425485|NCT00935883|E2|Reported Event|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425486|NCT00935883|E1|Reported Event|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
425487|NCT00935857|B3|Baseline|Total|Total of all reporting groups
425488|NCT00935857|B2|Baseline|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
425489|NCT00935857|B1|Baseline|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
425490|NCT00935857|P2|Participant Flow|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
425491|NCT00935857|P1|Participant Flow|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
425492|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
425493|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
425494|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
425495|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
425496|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
425497|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
425498|NCT00935857|E2|Reported Event|Single Balloon Colonoscopy|Patients who are randomized to received single balloon colonoscopy as initial treatment.
425499|NCT00935857|E1|Reported Event|Standard Colonoscopy|Patients who are randomized to received standard colonoscopy as initial treatment.
425500|NCT00935818|B3|Baseline|Total|Total of all reporting groups
425501|NCT00935818|B2|Baseline|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425502|NCT00935818|B1|Baseline|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425503|NCT00935818|P2|Participant Flow|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425504|NCT00935818|P1|Participant Flow|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425525|NCT00935792|P3|Participant Flow|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425506|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425507|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425508|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425509|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425510|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425511|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425512|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425513|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425514|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425515|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425516|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425517|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425518|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425519|NCT00935818|E2|Reported Event|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
425520|NCT00935818|E1|Reported Event|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
425521|NCT00935792|B4|Baseline|Total|Total of all reporting groups
425522|NCT00935792|B3|Baseline|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425523|NCT00935792|B2|Baseline|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425524|NCT00935792|B1|Baseline|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
430620|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
425526|NCT00935792|P2|Participant Flow|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425527|NCT00935792|P1|Participant Flow|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425528|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425529|NCT00935792|O1|Outcome|All Evaluable Patients|Patients are only evaluable for duration of response when they have already been noted as a complete response or partial response.
425530|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425531|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425532|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425533|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425534|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425535|NCT00935792|O3|Outcome|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425536|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425537|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425538|NCT00935792|E3|Reported Event|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425539|NCT00935792|E2|Reported Event|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425540|NCT00935792|E1|Reported Event|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
425541|NCT00935766|B3|Baseline|Total|Total of all reporting groups
425542|NCT00935766|B2|Baseline|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
425543|NCT00935766|B1|Baseline|Placebo|Placebo (Four 1-gram capsules daily)
425544|NCT00935766|P2|Participant Flow|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
425545|NCT00935766|P1|Participant Flow|Placebo|Placebo (Four 1-gram capsules daily)
425546|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
425547|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
425548|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
425549|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
425550|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
425551|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
425552|NCT00935766|E2|Reported Event|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
425553|NCT00935766|E1|Reported Event|Placebo|Placebo (Four 1-gram capsules daily)
425554|NCT00935701|B1|Baseline|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
425555|NCT00935701|P1|Participant Flow|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
425556|NCT00935701|O1|Outcome|Primary Group|
425557|NCT00935701|O1|Outcome|Primary Group|
425558|NCT00935701|O1|Outcome|Primary Group|
425559|NCT00935701|O1|Outcome|Primary Group|Phase 1
425560|NCT00935701|E1|Reported Event|Primary Group|
425561|NCT00935649|B1|Baseline|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
425562|NCT00935649|P1|Participant Flow|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
425563|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
425564|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
425565|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
425566|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
425567|NCT00935649|E2|Reported Event|Untreated Great Toe|untreated control great toe
425568|NCT00935649|E1|Reported Event|Treated Great Toe|Laser treatment of great toe
425569|NCT00935584|B3|Baseline|Total|Total of all reporting groups
425570|NCT00935584|B2|Baseline|PACE Study Providers|23 providers participated in the study. However, final analysis was based on 126 clinic visits.
425604|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425571|NCT00935584|B1|Baseline|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425572|NCT00935584|P2|Participant Flow|PACE Study Providers|23 primary care providers started and 19 completed the study. 22 primary care providers participated in the educational workshop.
425573|NCT00935584|P1|Participant Flow|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design). Pre-intervention phase consisted of baseline data collection on EMR usage and patient-physician communication.~126 patients started the study and 77 completed the study."
425574|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425575|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425576|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425577|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425578|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425579|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425580|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425581|NCT00935584|E1|Reported Event|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
425582|NCT00935532|B3|Baseline|Total|Total of all reporting groups
425583|NCT00935532|B2|Baseline|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425584|NCT00935532|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425585|NCT00935532|P2|Participant Flow|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425586|NCT00935532|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425587|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425588|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425589|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425590|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425591|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425592|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425593|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425594|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425595|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425596|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425597|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425598|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425599|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425600|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425601|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425602|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425603|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425607|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425608|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425609|NCT00935532|E2|Reported Event|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
425610|NCT00935532|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
425611|NCT00935493|B4|Baseline|Total|Total of all reporting groups
425612|NCT00935493|B3|Baseline|Placebo po Qhs|Placebo: Placebo po qhs
425613|NCT00935493|B2|Baseline|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
425614|NCT00935493|B1|Baseline|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
425615|NCT00935493|P3|Participant Flow|Placebo po Qhs|Placebo: Placebo po qhs
425616|NCT00935493|P2|Participant Flow|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
425617|NCT00935493|P1|Participant Flow|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
425618|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
425619|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
425620|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
425621|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
425622|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
425623|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
425624|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
425625|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
425626|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
425627|NCT00935493|E3|Reported Event|Placebo|Placebo: Placebo
425628|NCT00935493|E2|Reported Event|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
425629|NCT00935493|E1|Reported Event|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
425630|NCT00935311|B4|Baseline|Total|Total of all reporting groups
425631|NCT00935311|B3|Baseline|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425632|NCT00935311|B2|Baseline|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
425633|NCT00935311|B1|Baseline|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425634|NCT00935311|P3|Participant Flow|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425635|NCT00935311|P2|Participant Flow|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
425636|NCT00935311|P1|Participant Flow|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425637|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425638|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
425639|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425640|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425641|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
425642|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425643|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425644|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
425645|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425646|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425647|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
425648|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425649|NCT00935311|E3|Reported Event|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425650|NCT00935311|E2|Reported Event|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
425651|NCT00935311|E1|Reported Event|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
425652|NCT00935272|B3|Baseline|Total|Total of all reporting groups
425653|NCT00935272|B2|Baseline|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
425707|NCT00935064|E1|Reported Event|Aliskiren|300 mg, once daily, for 6 weeks
425708|NCT00934947|B3|Baseline|Total|Total of all reporting groups
425709|NCT00934947|B2|Baseline|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
430621|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
425654|NCT00935272|B1|Baseline|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
425655|NCT00935272|P2|Participant Flow|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
425656|NCT00935272|P1|Participant Flow|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
425657|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
425658|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
425659|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
425660|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
425661|NCT00935272|E3|Reported Event|Second Treatment|At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment.
425662|NCT00935272|E2|Reported Event|No Treatment|Safety included post treatment assessment, and assessments at each visit throughout the study.
425663|NCT00935272|E1|Reported Event|Treatment With Restylane|Safety included post treatment assessment, and assessments at each visit throughout the study.
425664|NCT00935259|B1|Baseline|All Participants|All enrolled participants
425665|NCT00935259|P2|Participant Flow|Placebo First, Then Simvastatin 40 mg|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
425666|NCT00935259|P1|Participant Flow|Simvastatin 40 mg, Then Placebo|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
425667|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
425668|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
425669|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
425670|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
425671|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
425672|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
425673|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
425674|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
425675|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
425676|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
425677|NCT00935259|E2|Reported Event|Placebo|Placebo to simvastatin tablets once daily for 2 weeks in either Period 1 or Period 2
425678|NCT00935259|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablets once daily for 2 weeks in either Period 1 or Period 2
425679|NCT00935220|B1|Baseline|Linagliptin 5mg|Linagliptin 5mg once daily
425680|NCT00935220|P1|Participant Flow|Linagliptin 5mg|Linagliptin 5mg once daily
425681|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425682|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425683|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425684|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425685|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425686|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425687|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425688|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425689|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
425690|NCT00935220|E1|Reported Event|Linagliptin 5mg|Linagliptin 5mg once daily
425691|NCT00935064|B3|Baseline|Total|Total of all reporting groups
425692|NCT00935064|B2|Baseline|Placebo|Once daily, for 6 weeks
425693|NCT00935064|B1|Baseline|Aliskiren|300 mg, once daily, for 6 weeks
425694|NCT00935064|P2|Participant Flow|Placebo|Once daily, for 6 weeks
425695|NCT00935064|P1|Participant Flow|Aliskiren|300 mg, once daily, for 6 weeks
425696|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
425697|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
425698|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
425699|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
425700|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
425701|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
425702|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
425710|NCT00934947|B1|Baseline|Sugar Pill|Identical to active drug in sight, taste, and smell.
425711|NCT00934947|P2|Participant Flow|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
425712|NCT00934947|P1|Participant Flow|Sugar Pill|Identical to active drug in sight, taste, and smell.
425713|NCT00934947|O2|Outcome|Placebo|Individuals enrolled in the study who received placebo
425714|NCT00934947|O1|Outcome|Propranolol|Individuals who were randomized to receive propranolol following an intention to treat analysis
425715|NCT00934947|O2|Outcome|Placebo|Individuals enrolled in the study who received placebo
425716|NCT00934947|O1|Outcome|Propranolol|Individuals who were randomized to receive propranolol following an intention to treat analysis
425717|NCT00934947|O2|Outcome|Placebo|Individuals enrolled in the study who received placebo
425718|NCT00934947|O1|Outcome|Propranolol|Individuals who were randomized to receive propranolol following an intention to treat analysis
425719|NCT00934947|O2|Outcome|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
425720|NCT00934947|O1|Outcome|Sugar Pill|Identical to active drug in sight, taste, and smell.
425721|NCT00934947|E2|Reported Event|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
425722|NCT00934947|E1|Reported Event|Sugar Pill|Identical to active drug in sight, taste, and smell.
425723|NCT00934921|B3|Baseline|Total|Total of all reporting groups
425724|NCT00934921|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
425725|NCT00934921|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
425726|NCT00934921|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
425727|NCT00934921|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
425728|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
425729|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
425730|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
425731|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
425732|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
425733|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
425734|NCT00934856|B7|Baseline|Total|Total of all reporting groups
425735|NCT00934856|B6|Baseline|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425736|NCT00934856|B5|Baseline|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425737|NCT00934856|B4|Baseline|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425738|NCT00934856|B3|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425739|NCT00934856|B2|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425740|NCT00934856|B1|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425741|NCT00934856|P6|Participant Flow|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425742|NCT00934856|P5|Participant Flow|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425786|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425787|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425788|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425743|NCT00934856|P4|Participant Flow|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425744|NCT00934856|P3|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425745|NCT00934856|P2|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425746|NCT00934856|P1|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with human epidermal growth factor receptor 2 (HER2)-positive MBC received docetaxel (Doc) 75 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 and trastuzumab emtansine (T-DM1) 2.4 milligrams per kilogram (mg/kg) IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425747|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
425748|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
425749|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
425750|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
425751|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
425752|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
425753|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
425754|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
425755|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
425756|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
425757|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
425758|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
425759|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
425760|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
425761|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
425762|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
425763|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
425764|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
425765|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
425766|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
425767|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
425768|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
425769|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
425770|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
425771|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
425772|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425773|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425774|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425775|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425776|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425777|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425778|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425779|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425780|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425781|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425782|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425783|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425784|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425785|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425789|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425790|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425791|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425792|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425793|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425794|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425795|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425796|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425797|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425798|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425799|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425800|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425801|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425802|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425803|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425804|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425805|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425806|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425807|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425808|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
425809|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
425810|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
425811|NCT00934856|O1|Outcome|Overall MBC and LABC Participants|All enrolled participants who received at least one dose of study medication
425812|NCT00934856|O2|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425813|NCT00934856|O1|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425814|NCT00934856|O2|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425815|NCT00934856|O1|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425816|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
425817|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
425818|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
425819|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
425820|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
425821|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
425822|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
425823|NCT00934856|O6|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425824|NCT00934856|O5|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425825|NCT00934856|O4|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425843|NCT00934843|B1|Baseline|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
425826|NCT00934856|O3|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425827|NCT00934856|O2|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425828|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425829|NCT00934856|O6|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425830|NCT00934856|O5|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425831|NCT00934856|O4|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425832|NCT00934856|O3|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425833|NCT00934856|O2|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425834|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425835|NCT00934856|E6|Reported Event|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425836|NCT00934856|E5|Reported Event|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
425837|NCT00934856|E4|Reported Event|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425838|NCT00934856|E3|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425839|NCT00934856|E2|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425840|NCT00934856|E1|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
425841|NCT00934843|B3|Baseline|Total|Total of all reporting groups
425842|NCT00934843|B2|Baseline|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
426161|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
425844|NCT00934843|P2|Participant Flow|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
425845|NCT00934843|P1|Participant Flow|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
425846|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
425847|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
425848|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
425849|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
425850|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
425851|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
425852|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
425853|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
425854|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
425855|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
425856|NCT00934843|E2|Reported Event|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
425857|NCT00934843|E1|Reported Event|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
425858|NCT00934791|B3|Baseline|Total|Total of all reporting groups
425859|NCT00934791|B2|Baseline|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
425860|NCT00934791|B1|Baseline|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
425861|NCT00934791|P2|Participant Flow|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
425862|NCT00934791|P1|Participant Flow|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
425863|NCT00934791|O2|Outcome|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
425864|NCT00934791|O1|Outcome|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
425865|NCT00934791|E2|Reported Event|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
425866|NCT00934791|E1|Reported Event|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
425867|NCT00934661|B3|Baseline|Total|Total of all reporting groups
425868|NCT00934661|B2|Baseline|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425869|NCT00934661|B1|Baseline|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425870|NCT00934661|P2|Participant Flow|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425871|NCT00934661|P1|Participant Flow|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425872|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425873|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425874|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425875|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425876|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425877|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425878|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425879|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425880|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425881|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425882|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425883|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425884|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425885|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425886|NCT00934661|O2|Outcome|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425887|NCT00934661|O1|Outcome|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425888|NCT00934661|E2|Reported Event|Placebo Group|"The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush~Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush"
425889|NCT00934661|E1|Reported Event|Extended Release Epidural Morphine|"Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline~Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline"
425890|NCT00934648|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
425891|NCT00934648|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
425892|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
425893|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
425894|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
425895|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
425896|NCT00934648|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
425897|NCT00934635|B10|Baseline|Total|Total of all reporting groups
425898|NCT00934635|B9|Baseline|Control|PET Scan Control
425899|NCT00934635|B8|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425900|NCT00934635|B7|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425901|NCT00934635|B6|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
425902|NCT00934635|B5|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
425903|NCT00934635|B4|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
425904|NCT00934635|B3|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425905|NCT00934635|B2|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
426162|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
425906|NCT00934635|B1|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425907|NCT00934635|P9|Participant Flow|Control|PET Scan Control
425908|NCT00934635|P8|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425909|NCT00934635|P7|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425910|NCT00934635|P6|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
425911|NCT00934635|P5|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
425912|NCT00934635|P4|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
425913|NCT00934635|P3|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425914|NCT00934635|P2|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425915|NCT00934635|P1|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425916|NCT00934635|O9|Outcome|Control|PET Scan Control
425917|NCT00934635|O8|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425918|NCT00934635|O7|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425919|NCT00934635|O6|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
425920|NCT00934635|O5|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
425921|NCT00934635|O4|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
425922|NCT00934635|O3|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425923|NCT00934635|O2|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425924|NCT00934635|O1|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425925|NCT00934635|E9|Reported Event|Control|PET Scan Control
425926|NCT00934635|E8|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425927|NCT00934635|E7|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
425928|NCT00934635|E6|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
425929|NCT00934635|E5|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
425930|NCT00934635|E4|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
425931|NCT00934635|E3|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425932|NCT00934635|E2|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425933|NCT00934635|E1|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
425934|NCT00934622|B1|Baseline|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
425935|NCT00934622|P1|Participant Flow|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
425936|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
425937|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
425938|NCT00934622|E1|Reported Event|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
425939|NCT00934596|B3|Baseline|Total|Total of all reporting groups
425940|NCT00934596|B2|Baseline|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before cannulation, CO2 was insufflated in the mediastinum at a flow rate of 10 litres/minute and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively re-filled with blood and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under transesophageal echocardiographic (TEE) monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to eject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
426163|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426164|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
425941|NCT00934596|B1|Baseline|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. Hereafter the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart defibrillated. After a good cardiac contraction and normal central hemodynamics were established, the LV preload was gradually and successively increased. When no air emboli were observed in the left side of the heart by transesophageal echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425942|NCT00934596|P2|Participant Flow|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the carbon-dioxide(CO2) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425943|NCT00934596|P1|Participant Flow|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart by Trans-esophageal Echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425944|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425945|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425946|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425947|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425986|NCT00934544|E1|Reported Event|INC424/INCB018424|"The starting dose of ruxolitinib tablets was determined based on baseline platelet count as follows: Subjects with baseline platelet count > 200, 000/µL began dosing at 20 mg bid (four 5 mg tablets bid) or Subjects with baseline platelet count of 100,000/µL to 200,000/µL (inclusive) began dosing at 15 mg bid (three 5 mg tablets bid).~A standardized dosing paradigm was used to determine dose adjustments for safety and efficacy so that each subject was titrated to their most appropriate dose."
426165|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
425948|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425949|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425950|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
425951|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425952|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425953|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425954|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425987|NCT00934440|B1|Baseline|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
426077|NCT00934050|B3|Baseline|1000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
425955|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425956|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425957|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425958|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425959|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425960|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
425961|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425988|NCT00934440|P1|Participant Flow|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
426078|NCT00934050|B2|Baseline|250mg BID/2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
430622|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
425962|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425963|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425964|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
425965|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425966|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
425967|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425968|NCT00934596|E2|Reported Event|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
426028|NCT00934141|P4|Participant Flow|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
426029|NCT00934141|P3|Participant Flow|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
426153|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
425969|NCT00934596|E1|Reported Event|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
425970|NCT00934544|B3|Baseline|Total|Total of all reporting groups
425971|NCT00934544|B2|Baseline|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
425972|NCT00934544|B1|Baseline|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
425973|NCT00934544|P2|Participant Flow|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
425974|NCT00934544|P1|Participant Flow|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
425975|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, or no therapy, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) was used.
425976|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg twice daily (BID) or 20 mg BID were selected with starting dose based on baseline platelet count. Starting dose was either 15 mg BID or 20 mg BID based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
425977|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
425978|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
425979|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
425980|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
425981|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
425982|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
425983|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
425984|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
425985|NCT00934544|E2|Reported Event|Best Available Therapy (BAT)|Best Available Therapy (BAT) was prescribed at doses and schedules selected by the Investigator on a subject-by-subject basis. BAT could include a single agent, combination of agents for the treatment of the disease and its symptoms or no therapy. Therapy could be changed at any time during the study EXCEPT during the screening period. No experimental drugs were permitted during the study.
426154|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
425989|NCT00934440|O1|Outcome|Dose Escalation: 5-azacitidine|"A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT’s are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.~Bevacizumab:~First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1~Second treatment: 10 MG/KG IV on Day 1~Third and subsequent treatments: 10 MG/KG IV on Day 1"
425990|NCT00934440|O1|Outcome|5-Azacitidine Maximum Tolerated Dose (MTD)|
425991|NCT00934440|E1|Reported Event|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
425992|NCT00934375|B3|Baseline|Total|Total of all reporting groups
425993|NCT00934375|B2|Baseline|Placebo|
425994|NCT00934375|B1|Baseline|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
425995|NCT00934375|P2|Participant Flow|Placebo|
425996|NCT00934375|P1|Participant Flow|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
425997|NCT00934375|O2|Outcome|Placebo|
425998|NCT00934375|O1|Outcome|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
425999|NCT00934375|E2|Reported Event|Placebo|
426000|NCT00934375|E1|Reported Event|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
426001|NCT00934362|B3|Baseline|Total|Total of all reporting groups
426002|NCT00934362|B2|Baseline|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
426003|NCT00934362|B1|Baseline|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
426004|NCT00934362|P2|Participant Flow|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
426005|NCT00934362|P1|Participant Flow|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
426006|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
426007|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
426008|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
426009|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
426010|NCT00934362|E2|Reported Event|Placebo|0.9% NaCl x 6 ml (5 doses)
426011|NCT00934362|E1|Reported Event|Lucinactant|20 mg/ml x 6 ml (5 doses)
426012|NCT00934180|B3|Baseline|Total|Total of all reporting groups
426013|NCT00934180|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
426014|NCT00934180|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
426015|NCT00934180|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
426016|NCT00934180|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
426017|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
426018|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
426019|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
426020|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
426021|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
426022|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
426023|NCT00934141|B5|Baseline|Total|Total of all reporting groups
426024|NCT00934141|B4|Baseline|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
426025|NCT00934141|B3|Baseline|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
426026|NCT00934141|B2|Baseline|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
426027|NCT00934141|B1|Baseline|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
426076|NCT00934050|B4|Baseline|2000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426030|NCT00934141|P2|Participant Flow|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
426031|NCT00934141|P1|Participant Flow|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
426032|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
426033|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
426034|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
426035|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
426036|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
426037|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
426038|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
426039|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
426040|NCT00934141|O4|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
426041|NCT00934141|O3|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
426042|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
426043|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
426044|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
426045|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
426155|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426046|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
426047|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
426048|NCT00934141|E4|Reported Event|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
426049|NCT00934141|E3|Reported Event|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
426050|NCT00934141|E2|Reported Event|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
426051|NCT00934141|E1|Reported Event|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
426052|NCT00934128|B3|Baseline|Total|Total of all reporting groups
426053|NCT00934128|B2|Baseline|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
426054|NCT00934128|B1|Baseline|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
426055|NCT00934128|P2|Participant Flow|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
426056|NCT00934128|P1|Participant Flow|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.
426057|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
426058|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
426059|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
426060|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
426061|NCT00934128|E2|Reported Event|Group 2: Vapotherm Then BiPAP|Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.
426062|NCT00934128|E1|Reported Event|Group1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.
426063|NCT00934102|B1|Baseline|Overall|This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed.
426064|NCT00934102|P3|Participant Flow|Lotrafilcon A / Galyfilcon A|Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
426065|NCT00934102|P2|Participant Flow|Narafilcon A / Galyfilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
426066|NCT00934102|P1|Participant Flow|Narafilcon A / Lotrafilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
426067|NCT00934102|O3|Outcome|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
426068|NCT00934102|O2|Outcome|Narafilcon A|Investigational, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
426069|NCT00934102|O1|Outcome|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
426070|NCT00934102|E3|Reported Event|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
426071|NCT00934102|E2|Reported Event|Narafilcon A|Experimental, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
426072|NCT00934102|E1|Reported Event|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
426073|NCT00934050|B7|Baseline|Total|Total of all reporting groups
426074|NCT00934050|B6|Baseline|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426075|NCT00934050|B5|Baseline|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426156|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426157|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426079|NCT00934050|B1|Baseline|Placebo/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426080|NCT00934050|P6|Participant Flow|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426081|NCT00934050|P5|Participant Flow|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426082|NCT00934050|P4|Participant Flow|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426083|NCT00934050|P3|Participant Flow|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426084|NCT00934050|P2|Participant Flow|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426085|NCT00934050|P1|Participant Flow|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426086|NCT00934050|O2|Outcome|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426087|NCT00934050|O1|Outcome|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426088|NCT00934050|E6|Reported Event|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426089|NCT00934050|E5|Reported Event|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
426090|NCT00934050|E4|Reported Event|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426091|NCT00934050|E3|Reported Event|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426092|NCT00934050|E2|Reported Event|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426093|NCT00934050|E1|Reported Event|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
426094|NCT00933933|B6|Baseline|Total|Total of all reporting groups
426095|NCT00933933|B5|Baseline|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
426096|NCT00933933|B4|Baseline|Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
426097|NCT00933933|B3|Baseline|Architect Ag/Ab Combo HIV-1 Antibody Sensitivity|Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
426098|NCT00933933|B2|Baseline|Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
426099|NCT00933933|B1|Baseline|Architect HIV Ag/Ab Combo Specificity|Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test.
426100|NCT00933933|P3|Participant Flow|Architect HIV Ag/Ab Combo Reactivity|"Reactivty populations included:~1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.~203 specimen from pregnant females at risk for HIV infection.~Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
426158|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426159|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426101|NCT00933933|P2|Participant Flow|Architect HIV Ag/Ab Combo Sensitivity|"Sensitivity populations included:~1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.~67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.~64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test."
426102|NCT00933933|P1|Participant Flow|Architect HIV Ag/Ab Combo Specificity|"Specificity populations included:~6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.~448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.~588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
426103|NCT00933933|O3|Outcome|Reactivity in Pregnant Female Population|Specimens collected from 203 pregnant females: 153 specimens collected from pregnant females with documented risk factors for HIV and 50 were surplus serum specimens collected pregnant females from a health clinic offering HIV testing. Spcimens from 55 of the pregnant females with risk for HIV infection were collected under a specimen collection protocol and tested with the investigational and FDA-licensed comparator assay during the study. The remaining specimens were obtained from specimen vendors and tested with the investigational HIV test.
426104|NCT00933933|O2|Outcome|Increased Risk for HIV From HIV-2 Endemic Area|Specimens from 513 individuals documented as being at risk for acquiring HIV that reside in an HIV-2 endemic area (Cote De'Ivoire) having one or more of the following risk factors: unprotected sex with someone who is infected with HIV, multiple sex partners, men who have sex with men, users of injecting drugs. Specimens were obtained from specimen vendors and tested with investigational HIV test.
426105|NCT00933933|O1|Outcome|Increased Risk for HIV in US Population|Specimens collected from 693 individuals in the US population documented as having one or more of the following risk factors: users of injecting drugs, unprotected sex with someone who is infected with HIV, diagnosed or treated for a sexually transmitted disease (STD), hepatitis or tuberculosis, multiple sex partners, men who have sex with men, men who have sex with men and are users of injecting drugs, unprotected sex with someone who has been diagnosed or treated for an STD, risk factor not identified but requested an HIV test. Specimens obtained from specimen vendors and were tested with investigational HIV test.
426106|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population|Specimens confirmed HIV positive by HIV-1 Western blot were tested with investigational HIV test. Specimens from individuals between 2 and 21 years of age.
426107|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pediatric Population|Specimens presumed HIV negative tested with investigational HIV test, FDA-licensed comparator assay and supplemental tests. Specimens from individuals between 2 and 21 years of age.
426108|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females|HIV confirmed positive specimens from pregnant females tested with investigation HIV test, comparator assay and supplement tests.
426109|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pregnant Females|HIV presumed negative specimens from pregnant females tested with investigation HIV test, comparator assay and supplemental tests.
426110|NCT00933933|O3|Outcome|HIV-2 Antibody Sensitivity|Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
426111|NCT00933933|O2|Outcome|HIV-1 Antibody Sensitivity|Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
426112|NCT00933933|O1|Outcome|HIV p24 Antgen Sensitivity|HIV-1 Antigen positive specimens/commercial panel members (HIV Westerm blot negative and confirmed positive by HIV-1 p24 Antigen and/or HIV RNA) and HIV-1 viral isolates.
426113|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection|Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
426114|NCT00933933|E3|Reported Event|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
426115|NCT00933933|E2|Reported Event|Architect HIV Ag/Ab Combo Sensitivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
426116|NCT00933933|E1|Reported Event|Architect HIV Ag/Ab Combo Specificity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
426117|NCT00933686|B3|Baseline|Total|Total of all reporting groups
426118|NCT00933686|B2|Baseline|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426119|NCT00933686|B1|Baseline|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426120|NCT00933686|P2|Participant Flow|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426121|NCT00933686|P1|Participant Flow|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426122|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426160|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426123|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426124|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426125|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426126|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426127|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426128|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426129|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426130|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426131|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426132|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426133|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426134|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426135|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426136|NCT00933686|E2|Reported Event|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
426137|NCT00933686|E1|Reported Event|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
426138|NCT00933608|B3|Baseline|Total|Total of all reporting groups
426139|NCT00933608|B2|Baseline|Placebo|
426140|NCT00933608|B1|Baseline|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
426141|NCT00933608|P2|Participant Flow|Placebo|participants were taking 1 tablet twice a day to match memantine arm
426142|NCT00933608|P1|Participant Flow|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
426143|NCT00933608|O2|Outcome|Placebo|participant will be taking 1 tablet twice a day to match active arm
426144|NCT00933608|O1|Outcome|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
426145|NCT00933608|E2|Reported Event|Placebo|
426146|NCT00933608|E1|Reported Event|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
426147|NCT00933543|B3|Baseline|Total|Total of all reporting groups
426148|NCT00933543|B2|Baseline|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426149|NCT00933543|B1|Baseline|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426150|NCT00933543|P2|Participant Flow|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426151|NCT00933543|P1|Participant Flow|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426152|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426166|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426167|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426168|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426169|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426170|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426171|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426172|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426173|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426174|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426175|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426176|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426177|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426178|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426179|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426180|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426181|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426182|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426183|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426184|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426185|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426186|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426187|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426188|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426189|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426190|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426191|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426192|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426193|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426194|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426195|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426196|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426197|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426198|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426199|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426200|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426201|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426202|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426203|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426204|NCT00933543|E2|Reported Event|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
426205|NCT00933543|E1|Reported Event|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
426206|NCT00933491|B3|Baseline|Total|Total of all reporting groups
426207|NCT00933491|B2|Baseline|Control|Non-diabetics
426208|NCT00933491|B1|Baseline|Diabetic|Type II Diabetes
426209|NCT00933491|P2|Participant Flow|Control|Non-diabetics
426210|NCT00933491|P1|Participant Flow|Diabetic|Type II Diabetes
426211|NCT00933491|O2|Outcome|Control|Non-diabetics
426212|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
426213|NCT00933491|O2|Outcome|Control|Non-diabetics
426214|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
426215|NCT00933491|E2|Reported Event|Control|Non-diabetics
426216|NCT00933491|E1|Reported Event|Diabetic|Type II Diabetes
426217|NCT00933335|B3|Baseline|Total|Total of all reporting groups
426218|NCT00933335|B2|Baseline|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426219|NCT00933335|B1|Baseline|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
426301|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426302|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426795|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
426220|NCT00933335|P2|Participant Flow|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426221|NCT00933335|P1|Participant Flow|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
426222|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426223|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426224|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426225|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426226|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426227|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426303|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426304|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426477|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426228|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426229|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426230|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426231|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426232|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426233|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426234|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426235|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426478|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426236|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426237|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426238|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426239|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426240|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426241|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426242|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426243|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426244|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426245|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426305|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426479|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426480|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426246|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426247|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426248|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426249|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426250|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426251|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426252|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426253|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426254|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426255|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426256|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426257|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426258|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426259|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426260|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426261|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426262|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426481|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
430623|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
426263|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426264|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426265|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426266|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426267|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426268|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426269|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426270|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426271|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426272|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426306|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426482|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426483|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426273|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426274|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426275|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426276|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426277|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426278|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426279|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426280|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426281|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426282|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426283|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426307|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
430624|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
426284|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426285|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426286|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
426287|NCT00933335|E3|Reported Event|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
426288|NCT00933335|E2|Reported Event|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
426289|NCT00933335|E1|Reported Event|Fludarabine|Participants who received any number of cycles of IV fludarabine monophosphate (25 mg/m^2/day). Each cycle was administered for 5 days every 5 to 6 weeks.
426290|NCT00933270|B1|Baseline|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426291|NCT00933270|P1|Participant Flow|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426292|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426293|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426294|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426295|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426296|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426297|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426298|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426299|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426300|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426484|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426308|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426309|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426310|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426311|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426312|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426313|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426314|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426315|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426316|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426317|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426318|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426319|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426320|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426321|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426322|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426323|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426324|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426325|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426326|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426327|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426328|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426329|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426330|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426331|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426332|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426485|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
430625|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
426333|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426334|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426335|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426336|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426337|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426338|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426339|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426340|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426341|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426342|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426343|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426344|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426345|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426346|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426347|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426348|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426349|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426350|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426351|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426352|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426353|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426354|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426355|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426356|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426357|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426486|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
430626|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
426358|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426359|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426360|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426361|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426362|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426363|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426364|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426365|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426366|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426367|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426368|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426369|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426370|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426371|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426372|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426373|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426374|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426375|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426376|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426377|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426378|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
426379|NCT00933270|E2|Reported Event|Supera® Peripheral Stent System Roll-in|"Implantation of Supera stent using the Supera® Peripheral Stent System.~There were a total of 61 roll-in subjects."
426380|NCT00933270|E1|Reported Event|Supera® Peripheral Stent System ITT|"Implantation of Supera stent using the Supera® Peripheral Stent System.~ITT population consisted of 264 subjects."
426381|NCT00933244|B4|Baseline|Total|Total of all reporting groups
426382|NCT00933244|B3|Baseline|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426417|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426792|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
426383|NCT00933244|B2|Baseline|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
426384|NCT00933244|B1|Baseline|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426385|NCT00933244|P3|Participant Flow|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426386|NCT00933244|P2|Participant Flow|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
426387|NCT00933244|P1|Participant Flow|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426388|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426389|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
426390|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426391|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426392|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
426393|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426394|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426395|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
426418|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
430627|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
426396|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426397|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426398|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
426399|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426400|NCT00933244|E3|Reported Event|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426401|NCT00933244|E2|Reported Event|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
426402|NCT00933244|E1|Reported Event|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
426403|NCT00933166|B1|Baseline|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
426404|NCT00933166|P1|Participant Flow|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
426405|NCT00933166|O1|Outcome|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
426406|NCT00933166|E1|Reported Event|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
426407|NCT00932893|B3|Baseline|Total|Total of all reporting groups
426408|NCT00932893|B2|Baseline|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426409|NCT00932893|B1|Baseline|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426410|NCT00932893|P2|Participant Flow|Chemotherapy|Pemetrexed 500 mg per square meter (mg/m^2) intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426411|NCT00932893|P1|Participant Flow|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426412|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426413|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426414|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426415|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426416|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426476|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426419|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426420|NCT00932893|O1|Outcome|Overall Values|Overall assessment for complete response, partial response, stable disease, progressive disease and early death
426421|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426422|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426423|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426424|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426425|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426426|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426427|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426428|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426429|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426430|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426431|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426432|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426433|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426434|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426435|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426436|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426437|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426438|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426439|NCT00932893|E2|Reported Event|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426440|NCT00932893|E1|Reported Event|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
426441|NCT00932828|B1|Baseline|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed ITT.
426442|NCT00932828|P1|Participant Flow|Peanut Oral Immunotherapy|All subjects are treated with peanut oral immunotherapy for primary outcome. Patients randomized to 300mg or 3000mg for secondary dose finding outcome.
426443|NCT00932828|O1|Outcome|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
426444|NCT00932828|O1|Outcome|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
426445|NCT00932828|O1|Outcome|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
426446|NCT00932828|E1|Reported Event|Peanut Oral Immunotherapy|All subjects who are treated with peanut OIT (300mg or 3000mg) and undergo a DBPCFC after 36 months of treatment and an additional DBPCFC after 4 weeks of treatment avoidance. Analysis was completed as ITT.
426447|NCT00932659|B1|Baseline|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
426448|NCT00932659|P1|Participant Flow|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
426449|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
426450|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
426451|NCT00932659|E1|Reported Event|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
426452|NCT00932646|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
426453|NCT00932646|P4|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
426454|NCT00932646|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
426455|NCT00932646|P2|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5mcg qd in the first period, Foradil 12 mcg bid in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
426456|NCT00932646|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
426457|NCT00932646|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426458|NCT00932646|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426459|NCT00932646|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426460|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426461|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426462|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426463|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426464|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
426465|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426466|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426467|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426468|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426469|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426470|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426471|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426472|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426473|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426474|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426475|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426487|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426488|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426489|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426490|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426491|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426492|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426493|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426494|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426495|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426496|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426497|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426498|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426499|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426500|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426501|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426502|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426503|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426504|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
426505|NCT00932646|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
426506|NCT00932646|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
426507|NCT00932646|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
426508|NCT00932646|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
426509|NCT00932620|B3|Baseline|Total|Total of all reporting groups
426510|NCT00932620|B2|Baseline|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
426511|NCT00932620|B1|Baseline|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
426512|NCT00932620|P2|Participant Flow|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
426513|NCT00932620|P1|Participant Flow|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
426514|NCT00932620|O2|Outcome|Simvastatin/Ezetimibe 10/10|
426515|NCT00932620|O1|Outcome|Simvastatin 40|
426516|NCT00932620|O2|Outcome|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
426517|NCT00932620|O1|Outcome|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
426518|NCT00932620|E2|Reported Event|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
426519|NCT00932620|E1|Reported Event|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
426520|NCT00932477|B1|Baseline|All Study Participants|All Study Participants
426521|NCT00932477|P6|Participant Flow|Sequence CBA|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1
426522|NCT00932477|P5|Participant Flow|Sequence CAB|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
426523|NCT00932477|P4|Participant Flow|Sequence BCA|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
426524|NCT00932477|P3|Participant Flow|Sequence BAC|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
426525|NCT00932477|P2|Participant Flow|Sequence ACB|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
426526|NCT00932477|P1|Participant Flow|Sequence ABC|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
426527|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
426528|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426529|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426530|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
426531|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426532|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426533|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
426534|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426535|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426536|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
426537|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426538|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
426539|NCT00932477|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
426540|NCT00932477|E2|Reported Event|Artificial Tear Formulation 2|Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
426541|NCT00932477|E1|Reported Event|Artificial Tear Formulation 1|Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
426542|NCT00932451|B1|Baseline|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426543|NCT00932451|P1|Participant Flow|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426544|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426545|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426546|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426547|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426548|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426549|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426550|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426551|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426552|NCT00932451|O2|Outcome|Crizotinib 250 mg BID-ALT Controls|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426553|NCT00932451|O1|Outcome|Crizotinib 250 mg BID-ALT Cases|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426554|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426555|NCT00932451|O2|Outcome|PF-06260182|PF-06260182 was a PF-02341066 metabolite measured in this study.
426556|NCT00932451|O1|Outcome|Crizotinib (PF-02341066)|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426557|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426558|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426559|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426793|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
426560|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426561|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426562|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426563|NCT00932451|E1|Reported Event|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
426564|NCT00932425|B3|Baseline|Total|Total of all reporting groups
426565|NCT00932425|B2|Baseline|Control|Patients discharged home with standard clinical follow-up
426566|NCT00932425|B1|Baseline|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426567|NCT00932425|P2|Participant Flow|Control|Patients discharged home with standard clinical follow-up
426568|NCT00932425|P1|Participant Flow|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426569|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426570|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
426571|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426572|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
426573|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426574|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
426575|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426576|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
426577|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426578|NCT00932425|E2|Reported Event|Control|Patients discharged home with standard clinical follow-up
426579|NCT00932425|E1|Reported Event|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
426580|NCT00932399|B3|Baseline|Total|Total of all reporting groups
426581|NCT00932399|B2|Baseline|Group 2|No history of lower limb amputation
426582|NCT00932399|B1|Baseline|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
426583|NCT00932399|P2|Participant Flow|Group 2|No history of lower limb amputation
426584|NCT00932399|P1|Participant Flow|Group 1|Underwent a procedure at a VA medical facility in Veterans Integrated Service Network #20 for a lower limb amputation between 1997 and 2008
426585|NCT00932399|O2|Outcome|Group 2|No history of lower limb amputation
426586|NCT00932399|O1|Outcome|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
426587|NCT00932399|E2|Reported Event|Group 2|No history of lower limb amputation
426588|NCT00932399|E1|Reported Event|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
426589|NCT00932373|B12|Baseline|Total|Total of all reporting groups
426590|NCT00932373|B11|Baseline|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426591|NCT00932373|B10|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426592|NCT00932373|B9|Baseline|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426593|NCT00932373|B8|Baseline|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426594|NCT00932373|B7|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426595|NCT00932373|B6|Baseline|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426596|NCT00932373|B5|Baseline|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426597|NCT00932373|B4|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426598|NCT00932373|B3|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426599|NCT00932373|B2|Baseline|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426600|NCT00932373|B1|Baseline|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426601|NCT00932373|P11|Participant Flow|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426602|NCT00932373|P10|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426603|NCT00932373|P9|Participant Flow|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426604|NCT00932373|P8|Participant Flow|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426605|NCT00932373|P7|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426606|NCT00932373|P6|Participant Flow|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426607|NCT00932373|P5|Participant Flow|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426608|NCT00932373|P4|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426609|NCT00932373|P3|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426610|NCT00932373|P2|Participant Flow|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426611|NCT00932373|P1|Participant Flow|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426612|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426613|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426614|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426615|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426616|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426617|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426618|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426619|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426620|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426621|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426622|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426623|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426624|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426625|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426626|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426627|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426628|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426629|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426630|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426631|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426632|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426633|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426634|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426635|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426636|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426637|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426638|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426639|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426640|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426641|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426642|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426643|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426644|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426645|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
426646|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
430628|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
426647|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426648|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426649|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426650|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426651|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426652|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426653|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426654|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426655|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426656|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426657|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426658|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
426659|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426660|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426661|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426662|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426663|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426664|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426665|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426666|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426667|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426668|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426669|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426670|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426671|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426672|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426673|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426674|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426675|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426676|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426677|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426678|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426679|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426680|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426681|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426682|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426683|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426684|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426685|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426686|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426687|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426688|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
426689|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
426690|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
426691|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
426692|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
426693|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426694|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426695|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426696|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426697|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426698|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426699|NCT00932373|E11|Reported Event|Trastuzumab-MCC-DM 2.9 mg/kg Weekly|2.9 mg/kg administered intravenously (IV) once a week
426700|NCT00932373|E10|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Weekly|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once a week
426701|NCT00932373|E9|Reported Event|Trastuzumab-MCC-DM 2.0 mg/kg Weekly|Trastuzumab-MCC-DM 2.0 mg/kg administered intravenously (IV) once a week
426702|NCT00932373|E8|Reported Event|Trastuzumab-MCC-DM 1.6 mg/kg Weekly|Trastuzumab-MCC-DM 1.6 mg/kg administered intravenously (IV) once a week
426703|NCT00932373|E7|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Weekly|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once a week
426704|NCT00932373|E6|Reported Event|Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 4.8 mg/kg administered intravenously (IV) once every 3 weeks
426705|NCT00932373|E5|Reported Event|Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 3.6 mg/kg administered intravenously (IV) once every 3 weeks
426706|NCT00932373|E4|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once every 3 weeks
426707|NCT00932373|E3|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once every 3 weeks
426708|NCT00932373|E2|Reported Event|Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.6 mg/kg administered intravenously (IV) once every 3 weeks
426709|NCT00932373|E1|Reported Event|Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.3 mg/kg administered intravenously (IV) once every 3 weeks
426710|NCT00932321|B3|Baseline|Total|Total of all reporting groups
426711|NCT00932321|B2|Baseline|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
426712|NCT00932321|B1|Baseline|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
426713|NCT00932321|P2|Participant Flow|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
426714|NCT00932321|P1|Participant Flow|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
426715|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
426716|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
426717|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
426718|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
426719|NCT00932321|E2|Reported Event|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
426720|NCT00932321|E1|Reported Event|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
426721|NCT00932282|B3|Baseline|Total|Total of all reporting groups
426722|NCT00932282|B2|Baseline|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426723|NCT00932282|B1|Baseline|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426724|NCT00932282|P2|Participant Flow|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426725|NCT00932282|P1|Participant Flow|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426726|NCT00932282|O2|Outcome|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426727|NCT00932282|O1|Outcome|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426728|NCT00932282|O2|Outcome|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426729|NCT00932282|O1|Outcome|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426730|NCT00932282|O2|Outcome|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426731|NCT00932282|O1|Outcome|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426732|NCT00932282|O2|Outcome|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426733|NCT00932282|O1|Outcome|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426734|NCT00932282|O2|Outcome|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426794|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
426735|NCT00932282|O1|Outcome|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426736|NCT00932282|E2|Reported Event|24 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 24 months prior to the desensitization food challenge.
426737|NCT00932282|E1|Reported Event|12 Month Maintenance of PnOIT|Subjects randomized to receive maintenance oral peanut immunotherapy (PnOIT) for 12 months prior to the desensitization food challenge.
426738|NCT00932165|B1|Baseline|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426739|NCT00932165|P1|Participant Flow|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426740|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426741|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426742|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426743|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426744|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
426745|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426746|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
426747|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426748|NCT00932165|E1|Reported Event|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
426749|NCT00932152|B3|Baseline|Total|Total of all reporting groups
426750|NCT00932152|B2|Baseline|Fulvestrant, Anastrozole and Bevacizumab|
426751|NCT00932152|B1|Baseline|Fulvestrant and Anastrozole Only|
426752|NCT00932152|P2|Participant Flow|Fulvestrant, Anastrozole and Bevacizumab|
426753|NCT00932152|P1|Participant Flow|Fulvestrant and Anastrozole Only|
426754|NCT00932152|O2|Outcome|Fulvestrant, Anastrozole and Bevacizumab|
426755|NCT00932152|O1|Outcome|Fulvestrant and Anastrozole Only|
426756|NCT00932152|O2|Outcome|Fulvestrant, Anastrozole and Bevacizumab|
426757|NCT00932152|O1|Outcome|Fulvestrant and Anastrozole Only|
426758|NCT00932152|O2|Outcome|Fulvestrant, Anastrozole and Bevacizumab|
426759|NCT00932152|O1|Outcome|Fulvestrant and Anastrozole Only|
426760|NCT00932152|O1|Outcome|All Participants (Overall Study)|
426761|NCT00932152|E1|Reported Event|All Participants (Overall Study)|
426762|NCT00932126|B1|Baseline|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID and 60 mg BID
426763|NCT00932126|P8|Participant Flow|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice dailly
426764|NCT00932126|P7|Participant Flow|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
426765|NCT00932126|P6|Participant Flow|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
426766|NCT00932126|P5|Participant Flow|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
426767|NCT00932126|P4|Participant Flow|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
426768|NCT00932126|P3|Participant Flow|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
426769|NCT00932126|P2|Participant Flow|PF-03758309, 1 mg Twice Daily (BID)|PF-03758309 1 mg administered orally twice daily
426770|NCT00932126|P1|Participant Flow|PF-03758309, 1 Milligram (mg) Once Daily (QD)|PF-03758309 1 mg administered orally once daily
426771|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426772|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426773|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426774|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426775|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426776|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426777|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426778|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426779|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426780|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
426781|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
426782|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
426783|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
426784|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
426785|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309, 10 mg BID PF-03758309 10 mg administered orally twice daily
426786|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
426787|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
426788|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
426789|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
426790|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
426791|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
426796|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
426797|NCT00932126|E8|Reported Event|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
426798|NCT00932126|E7|Reported Event|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
426799|NCT00932126|E6|Reported Event|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
426800|NCT00932126|E5|Reported Event|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
426801|NCT00932126|E4|Reported Event|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
426802|NCT00932126|E3|Reported Event|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
426803|NCT00932126|E2|Reported Event|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
426804|NCT00932126|E1|Reported Event|PF-03758309, 1 mg QD|PF-03758309, 1 mg administered orally once daily
426805|NCT00932113|B3|Baseline|Total|Total of all reporting groups
426806|NCT00932113|B2|Baseline|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426807|NCT00932113|B1|Baseline|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426808|NCT00932113|P2|Participant Flow|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426809|NCT00932113|P1|Participant Flow|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426810|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426811|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426812|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426813|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426825|NCT00932035|B2|Baseline|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
426814|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426815|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426816|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426817|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426818|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426819|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426820|NCT00932113|O2|Outcome|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426821|NCT00932113|O1|Outcome|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426822|NCT00932113|E2|Reported Event|Methotrexate (MTX)|"Patients dosed in single weekly doses of methotrexate 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.~Methotrexate: 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.~Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study."
426823|NCT00932113|E1|Reported Event|Adalimumab|"Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15).~Adalimumab (Humira): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks."
426824|NCT00932035|B3|Baseline|Total|Total of all reporting groups
426925|NCT00931801|O4|Outcome|Total|All study arms combined
426826|NCT00932035|B1|Baseline|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
426827|NCT00932035|P2|Participant Flow|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
426828|NCT00932035|P1|Participant Flow|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
426829|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
426830|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
426831|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
426832|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
426833|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
426834|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
426835|NCT00932035|E2|Reported Event|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
426836|NCT00932035|E1|Reported Event|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
426837|NCT00932022|B3|Baseline|Total|Total of all reporting groups
426838|NCT00932022|B2|Baseline|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426839|NCT00932022|B1|Baseline|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426840|NCT00932022|P2|Participant Flow|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426841|NCT00932022|P1|Participant Flow|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426842|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426843|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426844|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426845|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426846|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426847|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426848|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426849|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426850|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426851|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426852|NCT00932022|E2|Reported Event|Placebo|Placebo capsule taken orally once daily for 14 weeks.
426853|NCT00932022|E1|Reported Event|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
426854|NCT00931996|B1|Baseline|Antipsychotic|Antipsychotic treatment
426855|NCT00931996|P1|Participant Flow|Antipsychotic|Antipsychotic treatment
426856|NCT00931996|O1|Outcome|Antipsychotic|Antipsychotic treatment
426857|NCT00931996|E1|Reported Event|Antipsychotic|Antipsychotic treatment
426858|NCT00931918|B3|Baseline|Total|Total of all reporting groups
426859|NCT00931918|B2|Baseline|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426860|NCT00931918|B1|Baseline|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426861|NCT00931918|P2|Participant Flow|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426862|NCT00931918|P1|Participant Flow|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426863|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426864|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426865|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426866|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426867|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426868|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426869|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426870|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426871|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426872|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426873|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426926|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
430629|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
426874|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426875|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426876|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426877|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426878|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426879|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426880|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426881|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426882|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426883|NCT00931918|E2|Reported Event|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426884|NCT00931918|E1|Reported Event|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
426885|NCT00931879|B3|Baseline|Total|Total of all reporting groups
426886|NCT00931879|B2|Baseline|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426887|NCT00931879|B1|Baseline|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426888|NCT00931879|P2|Participant Flow|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426927|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
426928|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
426929|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
426889|NCT00931879|P1|Participant Flow|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426890|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426891|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426892|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426893|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426894|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426895|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426896|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426897|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426898|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426899|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426900|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426930|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
426931|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
426932|NCT00931801|E4|Reported Event|Total|All study arms combined
430630|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
426901|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426902|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426903|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426904|NCT00931879|O2|Outcome|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426905|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426906|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426907|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426908|NCT00931879|E2|Reported Event|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
426909|NCT00931879|E1|Reported Event|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
426910|NCT00931801|B4|Baseline|Total|Total of all reporting groups
426911|NCT00931801|B3|Baseline|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
426912|NCT00931801|B2|Baseline|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
426913|NCT00931801|B1|Baseline|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
426914|NCT00931801|P3|Participant Flow|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
426915|NCT00931801|P2|Participant Flow|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
426916|NCT00931801|P1|Participant Flow|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
426917|NCT00931801|O4|Outcome|Total|All study arms combined
426918|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
426919|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
426920|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
426921|NCT00931801|O4|Outcome|Total|All study arms combined
426922|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
426923|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
426924|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
426933|NCT00931801|E3|Reported Event|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
426934|NCT00931801|E2|Reported Event|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
426935|NCT00931801|E1|Reported Event|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
426936|NCT00931723|B3|Baseline|Total|Total of all reporting groups
426937|NCT00931723|B2|Baseline|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426938|NCT00931723|B1|Baseline|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426939|NCT00931723|P2|Participant Flow|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426940|NCT00931723|P1|Participant Flow|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426941|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426942|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426943|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426944|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426945|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426946|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426947|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426948|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426949|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426950|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426951|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426952|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426953|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426954|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426955|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426956|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426957|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426958|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426959|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426960|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426961|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426962|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426963|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426964|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426965|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426966|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426967|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426968|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426969|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426970|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426971|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426972|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426973|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426974|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426975|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426976|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426977|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426978|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426979|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426980|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426981|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426982|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426983|NCT00931723|E2|Reported Event|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
426984|NCT00931723|E1|Reported Event|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
426985|NCT00931710|B3|Baseline|Total|Total of all reporting groups
426986|NCT00931710|B2|Baseline|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
426987|NCT00931710|B1|Baseline|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
427077|NCT00931489|E2|Reported Event|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
426988|NCT00931710|P2|Participant Flow|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
426989|NCT00931710|P1|Participant Flow|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
426990|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
426991|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
426992|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
426993|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
426994|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
426995|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
426996|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
426997|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
426998|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
426999|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
427000|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
427001|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
427002|NCT00931710|E2|Reported Event|Losartan / HCTZ|Losartan / HCTZ
427003|NCT00931710|E1|Reported Event|Valsartan / Amlodipine / HCTZ|Valsartan / amlodipine / HCTZ
427004|NCT00931632|B3|Baseline|Total|Total of all reporting groups
427005|NCT00931632|B2|Baseline|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427006|NCT00931632|B1|Baseline|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427007|NCT00931632|P2|Participant Flow|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427008|NCT00931632|P1|Participant Flow|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427009|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427010|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427011|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427012|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427013|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427014|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427015|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427016|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427017|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427018|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427019|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427020|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427021|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427022|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427023|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427024|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427025|NCT00931632|E2|Reported Event|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
427026|NCT00931632|E1|Reported Event|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
427027|NCT00931528|B3|Baseline|Total|Total of all reporting groups
427028|NCT00931528|B2|Baseline|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427029|NCT00931528|B1|Baseline|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
427030|NCT00931528|P2|Participant Flow|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427031|NCT00931528|P1|Participant Flow|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
427032|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427033|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
427034|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427035|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
427036|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427037|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
427038|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427039|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
427040|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427041|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
427042|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427043|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
427044|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
430631|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
427045|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
427046|NCT00931528|E2|Reported Event|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
427047|NCT00931528|E1|Reported Event|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
427048|NCT00931515|B3|Baseline|Total|Total of all reporting groups
427049|NCT00931515|B2|Baseline|ProDisc|The ProDisc® total disc replacement system.
427050|NCT00931515|B1|Baseline|NuBac|The NUBAC® disc arthroplasty system.
427051|NCT00931515|P2|Participant Flow|ProDisc|The ProDisc® total disc replacement system.
427052|NCT00931515|P1|Participant Flow|NuBac|The NUBAC® disc arthroplasty system.
427053|NCT00931515|O2|Outcome|ProDisc|The ProDisc® device total disc replacement system.
427054|NCT00931515|O1|Outcome|NuBac|The NUBAC® disc arthroplasty system.
427055|NCT00931515|E2|Reported Event|ProDisc|The ProDisc® device total disc replacement system.
427056|NCT00931515|E1|Reported Event|NuBac|The NUBAC® disc arthroplasty system.
427057|NCT00931489|B6|Baseline|Total|Total of all reporting groups
427058|NCT00931489|B5|Baseline|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427059|NCT00931489|B4|Baseline|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
427060|NCT00931489|B3|Baseline|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427061|NCT00931489|B2|Baseline|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
427062|NCT00931489|B1|Baseline|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427063|NCT00931489|P5|Participant Flow|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427064|NCT00931489|P4|Participant Flow|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
427065|NCT00931489|P3|Participant Flow|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427066|NCT00931489|P2|Participant Flow|Normal Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
427067|NCT00931489|P1|Participant Flow|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427068|NCT00931489|O2|Outcome|"Neovascular Wet AMD Patients - Acute Non-responders"|"Subjects with neovascular (wet) AMD treated with 4 or more monthly injections of anti-VEGF without an adequate response (persistent fluid on OCT) Group 3 - non-responders"
427069|NCT00931489|O1|Outcome|"Neovascular Wet AMD Patients - Responders"|"Subjects with neovascular (wet) Age-related Macular Degeneration who respond to ranibizumab after 4 consecutive intraocular injections Group 1"
427070|NCT00931489|O2|Outcome|"Neovascular Wet AMD Patients - Acute Non-responders"|"Subjects with neovascular (wet) AMD treated with 4 or more monthly injections of anti-VEGF without an adequate response (persistent fluid on OCT) Group 3 - non-responders"
427071|NCT00931489|O1|Outcome|"Neovascular Wet AMD Patients - Responders"|"Subjects with neovascular (wet) Age-related Macular Degeneration who respond to ranibizumab after 4 consecutive intraocular injections Group 1"
427072|NCT00931489|O2|Outcome|Population Normals|Normals are subjects that do not have Age-related Macular Degeneration. Group 2
427073|NCT00931489|O1|Outcome|"Neovascular Wet Age-related Macular Degeneration Patients"|"Subjects with active neovascular (wet) AMD. This includes the subjects that responded to treatment (Ranibizumab 0.5mg intravitreal injections at four week intervals) Group 1, and chronic non-responders - those subjects who received four or more anti-VEGF intravitreal injections with persistent fluid on OCT, Group 3.~At baseline, 40 subjects were enrolled into Group 1 Following 4 months of treatment, 3 subjects were moved to Group 3."
427074|NCT00931489|E5|Reported Event|Wet AMD Patients Chronic Non-responderes|"Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427075|NCT00931489|E4|Reported Event|Dry AMD Population|Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
427076|NCT00931489|E3|Reported Event|Wet AMD Patients Acute Non-responders|"Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427261|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427078|NCT00931489|E1|Reported Event|Wet AMD Patients Responders|"Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.~ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months"
427079|NCT00931463|B3|Baseline|Total|Total of all reporting groups
427080|NCT00931463|B2|Baseline|Ritonavir-boosted Lopinavir and Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily
427081|NCT00931463|B1|Baseline|Ritonavir-boosted Lopinavir and 2N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
427082|NCT00931463|P2|Participant Flow|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
427083|NCT00931463|P1|Participant Flow|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
427084|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
427085|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
427086|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
427087|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
427088|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
427089|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
427090|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
427091|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
427092|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
427093|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
427094|NCT00931463|E2|Reported Event|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
427095|NCT00931463|E1|Reported Event|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
427096|NCT00931411|B3|Baseline|Total|Total of all reporting groups
427097|NCT00931411|B2|Baseline|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
427098|NCT00931411|B1|Baseline|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
427099|NCT00931411|P2|Participant Flow|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
427100|NCT00931411|P1|Participant Flow|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
427101|NCT00931411|O1|Outcome|All Study Patients|
427102|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
427103|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
427104|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427105|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427106|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
427137|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427107|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
427108|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427109|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427110|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427111|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427112|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427113|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427114|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427115|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427116|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427117|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
427118|NCT00931411|E2|Reported Event|Formulation 609209|"Adverse events that were recorded before Day 42 for the group Formulation 609209 then 609580 20 and recorded in the subsequent 2 weeks for the group Formulation 609580 20 then 609209. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
427119|NCT00931411|E1|Reported Event|Formulation 609580 20|"Adverse events that were recorded before Day 42 for the group Formulation 609580 20 then 609209 and recorded in the subsequent 2 weeks for the group Formulation 609209 then 609580 20. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
427120|NCT00931385|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
427121|NCT00931385|P4|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered matching Placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
427122|NCT00931385|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, matching Placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
427123|NCT00931385|P2|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and matching Placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
427124|NCT00931385|P1|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Foradil 12 mcg bid in the second period, matching Placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
427125|NCT00931385|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427126|NCT00931385|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427127|NCT00931385|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427128|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427129|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427130|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427131|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427132|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427133|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427134|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427135|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427136|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427138|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427139|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427140|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427141|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427142|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427143|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427144|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427145|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427146|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427147|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427148|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427149|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427150|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427151|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427152|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427153|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427154|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427155|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427156|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427157|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427158|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427159|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427160|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427161|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427162|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427163|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427164|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427165|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427166|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427167|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427168|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427169|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427170|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427171|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427172|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
427173|NCT00931385|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
427174|NCT00931385|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
427175|NCT00931385|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
427176|NCT00931385|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427177|NCT00931359|B3|Baseline|Total|Total of all reporting groups
427178|NCT00931359|B2|Baseline|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
427179|NCT00931359|B1|Baseline|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
427180|NCT00931359|P2|Participant Flow|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
427181|NCT00931359|P1|Participant Flow|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
427182|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
427183|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
427184|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
427185|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
427186|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
427187|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
427188|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
427189|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
427190|NCT00931359|E2|Reported Event|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
430632|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
427191|NCT00931359|E1|Reported Event|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
427192|NCT00931307|B1|Baseline|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
427193|NCT00931307|P1|Participant Flow|Lotrafilcon A|Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner
427194|NCT00931307|O1|Outcome|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
427195|NCT00931307|E1|Reported Event|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
427196|NCT00931268|B1|Baseline|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427197|NCT00931268|P1|Participant Flow|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427198|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427199|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427200|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427201|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427202|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427203|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427204|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427205|NCT00931268|E1|Reported Event|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
427206|NCT00931255|B3|Baseline|Total|Total of all reporting groups
427207|NCT00931255|B2|Baseline|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427208|NCT00931255|B1|Baseline|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427209|NCT00931255|P2|Participant Flow|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427210|NCT00931255|P1|Participant Flow|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427211|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427212|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427213|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427214|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427215|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427216|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427217|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427218|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427219|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427220|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427221|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427222|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427223|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427224|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427225|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427260|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
430633|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
427226|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427227|NCT00931255|O2|Outcome|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427228|NCT00931255|O1|Outcome|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427229|NCT00931255|E2|Reported Event|Sirolimus|"5 mg, PO , daily~Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol"
427230|NCT00931255|E1|Reported Event|Tacrolimus|"Tacrolimus will be continued with target 12-hour trough level 7-10 ng/ml (tandem mass spectrometry) during the first year and 5-8 during second year.~Tacrolimus: 3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol"
427231|NCT00931242|B3|Baseline|Total|Total of all reporting groups
427232|NCT00931242|B2|Baseline|Screen Failures|Subjects that were screened but failed to meet inclusion criteria for the study.
427233|NCT00931242|B1|Baseline|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis.
427234|NCT00931242|P2|Participant Flow|Screen Failures|Patients who were screened but failed to meet inclusion criteria for the study
427235|NCT00931242|P1|Participant Flow|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
427236|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
427237|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
427238|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
427239|NCT00931242|E1|Reported Event|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
427240|NCT00931164|B1|Baseline|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
427241|NCT00931164|P1|Participant Flow|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
427242|NCT00931164|O1|Outcome|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
427243|NCT00931164|E1|Reported Event|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
427244|NCT00930982|B3|Baseline|Total|Total of all reporting groups
427245|NCT00930982|B2|Baseline|Placebo|Inhalation of matching placebo twice a day
427246|NCT00930982|B1|Baseline|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427247|NCT00930982|P2|Participant Flow|Placebo|Inhalation of matching placebo twice a day
427248|NCT00930982|P1|Participant Flow|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427249|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427250|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427251|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427252|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427253|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427254|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427255|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427256|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427257|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427258|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427259|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427262|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427263|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427264|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427265|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427266|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427267|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427268|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427269|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427270|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427271|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427272|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427273|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427274|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427275|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427276|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427277|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
427278|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427279|NCT00930982|E2|Reported Event|Placebo|Inhalation of matching placebo twice a day
427280|NCT00930982|E1|Reported Event|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
427281|NCT00930969|B1|Baseline|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427282|NCT00930969|P1|Participant Flow|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427283|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427284|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427285|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427286|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427287|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427288|NCT00930969|E1|Reported Event|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
427289|NCT00930930|B3|Baseline|Total|Total of all reporting groups
427290|NCT00930930|B2|Baseline|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427291|NCT00930930|B1|Baseline|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427292|NCT00930930|P2|Participant Flow|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427293|NCT00930930|P1|Participant Flow|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427294|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427295|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427327|NCT00930774|B2|Baseline|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427328|NCT00930774|B1|Baseline|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427329|NCT00930774|P4|Participant Flow|Standard-of-Care|Standard-of-care informational counseling
427296|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427297|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427298|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427299|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427300|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427301|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427302|NCT00930930|E2|Reported Event|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427303|NCT00930930|E1|Reported Event|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
427304|NCT00930813|B3|Baseline|Total|Total of all reporting groups
427305|NCT00930813|B2|Baseline|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
427306|NCT00930813|B1|Baseline|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
427307|NCT00930813|P2|Participant Flow|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
427308|NCT00930813|P1|Participant Flow|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
427309|NCT00930813|O2|Outcome|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
427310|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
427311|NCT00930813|O2|Outcome|Standard Uncoated PTA Catheter|Standard off-the-shelf uncoated PTA Catheter
427312|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel Coated Balloon Catheter
427313|NCT00930813|E2|Reported Event|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
427314|NCT00930813|E1|Reported Event|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
427315|NCT00930787|B3|Baseline|Total|Total of all reporting groups
427316|NCT00930787|B2|Baseline|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
427317|NCT00930787|B1|Baseline|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
427318|NCT00930787|P2|Participant Flow|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
427319|NCT00930787|P1|Participant Flow|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
427320|NCT00930787|O2|Outcome|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
427321|NCT00930787|O1|Outcome|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
427322|NCT00930787|E2|Reported Event|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
427323|NCT00930787|E1|Reported Event|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
427324|NCT00930774|B5|Baseline|Total|Total of all reporting groups
427325|NCT00930774|B4|Baseline|Standard-of-Care|Standard-of-care informational counseling
427326|NCT00930774|B3|Baseline|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427378|NCT00930761|O2|Outcome|Music Therapy|
427379|NCT00930761|O1|Outcome|Control|
427330|NCT00930774|P3|Participant Flow|FM System and Auditory Training|"Provision of frequency modulation (FM) assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427331|NCT00930774|P2|Participant Flow|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427332|NCT00930774|P1|Participant Flow|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427333|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427334|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427335|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427336|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427337|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427338|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427339|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427340|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427341|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427342|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427343|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427344|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427345|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427346|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427347|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427348|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427349|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427350|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427351|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427352|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427353|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427354|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427355|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427356|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427357|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427358|NCT00930774|O3|Outcome|FM Sytem + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427359|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427360|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427361|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
427362|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427363|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427364|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427365|NCT00930774|E4|Reported Event|Standard-of-care|Standard-of-care informational counseling
427366|NCT00930774|E3|Reported Event|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
427367|NCT00930774|E2|Reported Event|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
427368|NCT00930774|E1|Reported Event|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
427369|NCT00930761|B3|Baseline|Total|Total of all reporting groups
427370|NCT00930761|B2|Baseline|Music Therapy|
427371|NCT00930761|B1|Baseline|Control|
427372|NCT00930761|P2|Participant Flow|Music Therapy|
427373|NCT00930761|P1|Participant Flow|Control|
427374|NCT00930761|O2|Outcome|Music Therapy|
427375|NCT00930761|O1|Outcome|Control|
427376|NCT00930761|O2|Outcome|Music Therapy|
427377|NCT00930761|O1|Outcome|Control|
427384|NCT00930722|B1|Baseline|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427385|NCT00930722|P1|Participant Flow|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427386|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427387|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427388|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427389|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427390|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427391|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427392|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427393|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427394|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427395|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427396|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427397|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427398|NCT00930722|E1|Reported Event|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
427399|NCT00930644|B1|Baseline|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
427400|NCT00930644|P1|Participant Flow|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
427401|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427402|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427403|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427404|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427405|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427406|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427407|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427408|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427409|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427410|NCT00930644|E2|Reported Event|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427411|NCT00930644|E1|Reported Event|NT,PBO/TED|No treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
427440|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427441|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427555|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
427412|NCT00930553|B1|Baseline|Alemtuzumab|Participants enrolled from any of the previous studies received long-term follow-up in this study. Participants randomized to receive IFNB-1a in any of the previous studies received alemtuzumab 12 mg/day infusion IV, QD for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on MRI), unless they met safety-related retreatment disqualifying criteria.
427413|NCT00930553|P1|Participant Flow|Alemtuzumab|Participants enrolled from any of the prior studies received long-term follow-up in this study. Participants randomized to receive interferon beta-1a (IFNB-1a) in prior studies received alemtuzumab 12 mg/day infusion intravenously (IV) once daily (QD) for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on magnetic resonance imaging [MRI]), unless they met safety-related retreatment disqualifying criteria.
427414|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427415|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427416|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427417|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427418|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427419|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427420|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427421|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427422|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427423|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427424|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427425|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427426|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427427|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427428|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427429|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427430|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427431|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427432|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427433|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427434|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427435|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427436|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427437|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427438|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427439|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427442|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427443|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427444|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427445|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427446|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
427447|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427448|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427449|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427450|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427451|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427452|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427453|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
427454|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427455|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427456|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427457|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427458|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
427459|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
427460|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427461|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427462|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
427463|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
427464|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427465|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427466|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427467|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427468|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
427469|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
427470|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 (NCT00530348) or CAMMS324 (NCT00548405), received an additional course of alemtuzumab in this study.
427471|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427472|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427473|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
427474|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
427475|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study (CAMMS03409).
427476|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study (CAMMS03409).
427477|NCT00930553|E1|Reported Event|Alemtuzumab|Participants enrolled in any of the previous studies who had received alemtuzumab. Participants enrolled in any of the previous studies who had received IFNB-1a, who received alemtuzumab 12 mg/day infusion in this study.
427478|NCT00930293|B3|Baseline|Total|Total of all reporting groups
427479|NCT00930293|B2|Baseline|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427480|NCT00930293|B1|Baseline|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427481|NCT00930293|P2|Participant Flow|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427482|NCT00930293|P1|Participant Flow|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427483|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427484|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427485|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427486|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427487|NCT00930293|E2|Reported Event|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427488|NCT00930293|E1|Reported Event|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
427489|NCT00930176|B1|Baseline|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
427490|NCT00930176|P1|Participant Flow|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
427491|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
427492|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
427493|NCT00930176|E1|Reported Event|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
427494|NCT00929981|B1|Baseline|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427495|NCT00929981|P1|Participant Flow|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427496|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427497|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427554|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
427498|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427499|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427500|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427501|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427502|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427503|NCT00929981|E1|Reported Event|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
427504|NCT00929864|B3|Baseline|Total|Total of all reporting groups
427505|NCT00929864|B2|Baseline|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427506|NCT00929864|B1|Baseline|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427507|NCT00929864|P2|Participant Flow|40 mg Adalimumab SC Biweekly|Adalimumab 40 mg, biweekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427508|NCT00929864|P1|Participant Flow|125 mg Abatacept SC Weekly|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427509|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427510|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427511|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427512|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427513|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427514|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427515|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427516|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
430634|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
427517|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427518|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427519|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427520|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427521|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427522|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427523|NCT00929864|E2|Reported Event|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427524|NCT00929864|E1|Reported Event|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
427525|NCT00929773|B3|Baseline|Total|Total of all reporting groups
427526|NCT00929773|B2|Baseline|Placebo Laser|inactive light
427527|NCT00929773|B1|Baseline|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
427528|NCT00929773|P2|Participant Flow|Placebo Laser|inactive light
427529|NCT00929773|P1|Participant Flow|Erchonia PL2000 Laser|Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area .
427530|NCT00929773|O2|Outcome|Placebo Laser|inactive light
427531|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
427532|NCT00929773|O2|Outcome|Placebo Laser|inactive light
427533|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
427534|NCT00929773|O2|Outcome|Placebo Laser|inactive light
427535|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
427536|NCT00929773|O2|Outcome|Placebo Laser|inactive light
427537|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
427538|NCT00929773|O2|Outcome|Placebo Laser|inactive light
427539|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
427540|NCT00929773|O2|Outcome|Placebo Laser|inactive light
427541|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
427542|NCT00929773|E2|Reported Event|Placebo Laser|inactive light
427543|NCT00929773|E1|Reported Event|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
427544|NCT00929734|B3|Baseline|Total|Total of all reporting groups
427545|NCT00929734|B2|Baseline|Placebo|Placebo tablet
427546|NCT00929734|B1|Baseline|Rosuvastatin|Rosuvastatin 10mg tablet
427547|NCT00929734|P2|Participant Flow|Placebo|Placebo: 1 tablet, once daily in three months
427548|NCT00929734|P1|Participant Flow|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
427549|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
427550|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
427551|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
427552|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
427553|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
427556|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
427557|NCT00929734|E2|Reported Event|Placebo|Placebo: 1 tablet, once daily in three months
427558|NCT00929734|E1|Reported Event|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
427559|NCT00929708|B6|Baseline|Total|Total of all reporting groups
427560|NCT00929708|B5|Baseline|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427561|NCT00929708|B4|Baseline|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427562|NCT00929708|B3|Baseline|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427563|NCT00929708|B2|Baseline|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427564|NCT00929708|B1|Baseline|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427565|NCT00929708|P5|Participant Flow|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427566|NCT00929708|P4|Participant Flow|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427567|NCT00929708|P3|Participant Flow|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427568|NCT00929708|P2|Participant Flow|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427569|NCT00929708|P1|Participant Flow|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427570|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427571|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427572|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427573|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427574|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427575|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427576|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427577|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427578|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427579|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427580|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427581|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427582|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427583|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427584|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427585|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427586|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427587|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427588|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427589|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427590|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427591|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427592|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427593|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427594|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427595|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427596|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427597|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427598|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427599|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427600|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427601|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427602|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427603|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427604|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427605|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427606|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427607|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427608|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427609|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
430635|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
427610|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427611|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427612|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427613|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427614|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427615|NCT00929708|E5|Reported Event|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
427616|NCT00929708|E4|Reported Event|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
427617|NCT00929708|E3|Reported Event|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
427618|NCT00929708|E2|Reported Event|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
427619|NCT00929708|E1|Reported Event|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
427620|NCT00929695|B3|Baseline|Total|Total of all reporting groups
427621|NCT00929695|B2|Baseline|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427622|NCT00929695|B1|Baseline|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427623|NCT00929695|P2|Participant Flow|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427624|NCT00929695|P1|Participant Flow|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427625|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427626|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427627|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427628|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427629|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427630|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427631|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427632|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427633|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427634|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427635|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427636|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427637|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427638|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427639|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427737|NCT00929500|O2|Outcome|Usual Care|Usual Care (UC) with Educational Lectures
428097|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
427640|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427641|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427642|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427643|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
427644|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427645|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427646|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
427647|NCT00929695|O4|Outcome|Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
427648|NCT00929695|O3|Outcome|Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
427649|NCT00929695|O2|Outcome|Grade IIa GVHD; 1.0 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
427650|NCT00929695|O1|Outcome|Grade IIa GVHD; 0.5 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
427651|NCT00929695|E2|Reported Event|Arm II (Standard-dose)|"Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
427652|NCT00929695|E1|Reported Event|Arm I (Low-dose)|"Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
427653|NCT00929669|B1|Baseline|Pasireotide LAR|80 mg IM once monthly
427654|NCT00929669|P1|Participant Flow|Pasireotide LAR|80 mg IM once monthly
427655|NCT00929669|O1|Outcome|Pasireotide LAR|80 mg IM once monthly
427656|NCT00929669|O1|Outcome|Pasireotide LAR|80 mg IM once monthly
427657|NCT00929669|E1|Reported Event|Pasireotide LAR|80 mg IM once monthly
427658|NCT00929656|B3|Baseline|Total|Total of all reporting groups
427659|NCT00929656|B2|Baseline|Unimanual UE Training + Sham rTMS|Participants randomized to the Placebo Arm received sham rTMS to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
427660|NCT00929656|B1|Baseline|Unimanual UE Training + Real rTMS|Participants randomized to the Experimental Arm received real rTMS (1000 pulses) to their ipsilesional hemisphere followed by two hours of paretic arm functional task practice administered/supervised by a physical therapist.
427661|NCT00929656|P2|Participant Flow|Unimanual UE Training + Sham rTMS|"Unimanual Upper Extremity (UE) training + sham repetitive Transcranial Magnetic Stimulation (rTMS)~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427662|NCT00929656|P1|Participant Flow|Unimanual UE Training + Real rTMS|"Unimanual Upper Extremity (UE) training + repetitive Transcranial Magnetic Stimulation (rTMS)~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427663|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427664|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427665|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427666|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427667|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427668|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427669|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427670|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427671|NCT00929656|O2|Outcome|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427672|NCT00929656|O1|Outcome|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE functional task practice (2 hours) for 16 sessions (4 sessions/week for 4 weeks)"
427673|NCT00929656|E2|Reported Event|Unimanual UE Training + Sham rTMS|"Unimanual UE training + sham rTMS~Unimanual UE training + sham rTMS: sham rTMS application to lesioned hemisphere followed by unimanual (paretic) UE exercise (100 repetitions) for 16 sessions (4 sessions/week for 4 weeks)"
427674|NCT00929656|E1|Reported Event|Unimanual UE Training + Real rTMS|"Unimanual UE training + rTMS~Unimanual UE training + rTMS: rTMS application to lesioned hemisphere followed by unimanual (paretic) UE exercise (100 repetitions) for 16 sessions (4 sessions/week for 4 weeks)"
427675|NCT00929643|B1|Baseline|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427676|NCT00929643|P1|Participant Flow|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427677|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427678|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427679|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427680|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427681|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427682|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427683|NCT00929643|E1|Reported Event|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
427684|NCT00929578|B1|Baseline|All Study Participants - Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
427685|NCT00929578|P1|Participant Flow|All Study Participants|The sterile placebo: Bacteriostatic Sodium Chloride for Injection. Same subject will also receive dose in other arm of fluphenazine. This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
427686|NCT00929578|O3|Outcome|1 Week Post Dose|Participants with fluphenazine serum levels > 0.200ng/ml
427687|NCT00929578|O2|Outcome|2 Hours Post Dose|Number of participants with fluphenazine serum levels > 0.200ng/ml, 2 hours after administration
427688|NCT00929578|O1|Outcome|Baseline|Number of participants with fluphenazine serum levels > 0.200ng/ml at baseline
427689|NCT00929578|O1|Outcome|All Study Participants|Participants who experienced at least one adverse event.
427690|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
427691|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
427738|NCT00929500|O1|Outcome|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
427739|NCT00929500|O2|Outcome|Usual Care|Usual Care (UC) with Educational Lectures
427692|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
427693|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
427694|NCT00929578|E1|Reported Event|All Study Participants|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion. All participants received medication, as the study was a split study, and subjects received placebo on one side and injection of fluphenazine on other side
427695|NCT00929526|B3|Baseline|Total|Total of all reporting groups
427696|NCT00929526|B2|Baseline|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427697|NCT00929526|B1|Baseline|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427698|NCT00929526|P2|Participant Flow|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427699|NCT00929526|P1|Participant Flow|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427700|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427701|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427702|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427703|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427704|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427705|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427706|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427707|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427708|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427709|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427710|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427711|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427712|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427713|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427714|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427715|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427716|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427717|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427718|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427719|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427720|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427721|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427722|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427723|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427724|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427725|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427726|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427727|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427728|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427729|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427730|NCT00929526|E2|Reported Event|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
427731|NCT00929526|E1|Reported Event|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
427732|NCT00929500|B3|Baseline|Total|Total of all reporting groups
427733|NCT00929500|B2|Baseline|Usual Care|Usual Care (UC) with Educational Lectures
427734|NCT00929500|B1|Baseline|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
427735|NCT00929500|P2|Participant Flow|Usual Care|Usual Care (UC) with Educational Lectures
427736|NCT00929500|P1|Participant Flow|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
427740|NCT00929500|O1|Outcome|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
427741|NCT00929500|O2|Outcome|Usual Care|Usual Care (UC) with Educational Lectures
427742|NCT00929500|O1|Outcome|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
427743|NCT00929500|O2|Outcome|Usual Care|Usual Care (UC) with Educational Lectures
427744|NCT00929500|O1|Outcome|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
427745|NCT00929500|E2|Reported Event|Usual Care|Usual Care (UC) with Educational Lectures
427746|NCT00929500|E1|Reported Event|MAST Program|"Mixed Aerobic and Strength Training program (MAST)~MAST program: MAST program: twice a week for 4 months"
427747|NCT00929474|B3|Baseline|Total|Total of all reporting groups
427748|NCT00929474|B2|Baseline|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
427749|NCT00929474|B1|Baseline|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
427750|NCT00929474|P2|Participant Flow|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
427751|NCT00929474|P1|Participant Flow|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
427752|NCT00929474|O2|Outcome|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
427753|NCT00929474|O1|Outcome|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
427754|NCT00929474|E2|Reported Event|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
427755|NCT00929474|E1|Reported Event|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
427756|NCT00929383|B1|Baseline|Patients Treated With a Wingspan Stent|Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427757|NCT00929383|P1|Participant Flow|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427758|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427759|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427760|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427761|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427762|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427898|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427763|NCT00929383|E1|Reported Event|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
427764|NCT00929357|B3|Baseline|Total|Total of all reporting groups
427765|NCT00929357|B2|Baseline|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427766|NCT00929357|B1|Baseline|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427767|NCT00929357|P2|Participant Flow|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427768|NCT00929357|P1|Participant Flow|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427769|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427770|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427771|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427772|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427773|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427774|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427775|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427776|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427777|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427778|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427779|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427780|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427781|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427782|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427783|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427784|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427785|NCT00929357|E2|Reported Event|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
427786|NCT00929357|E1|Reported Event|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
427787|NCT00929344|B4|Baseline|Total|Total of all reporting groups
427788|NCT00929344|B3|Baseline|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427789|NCT00929344|B2|Baseline|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
430636|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
427790|NCT00929344|B1|Baseline|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427791|NCT00929344|P3|Participant Flow|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427792|NCT00929344|P2|Participant Flow|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427793|NCT00929344|P1|Participant Flow|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427794|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427795|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427796|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427797|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427798|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427799|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427800|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427801|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427802|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427803|NCT00929344|E3|Reported Event|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427804|NCT00929344|E2|Reported Event|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427805|NCT00929344|E1|Reported Event|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
427806|NCT00929331|B3|Baseline|Total|Total of all reporting groups
427807|NCT00929331|B2|Baseline|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427808|NCT00929331|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427809|NCT00929331|P2|Participant Flow|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427810|NCT00929331|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427811|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427812|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427813|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427814|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427815|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427816|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
428098|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
427817|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427818|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427819|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427820|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427821|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427822|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427823|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427824|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427825|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427826|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427827|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427828|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427829|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427830|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427831|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427832|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427833|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427834|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427835|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427836|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427837|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427838|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427839|NCT00929331|E2|Reported Event|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427840|NCT00929331|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
427841|NCT00929305|B3|Baseline|Total|Total of all reporting groups
427842|NCT00929305|B2|Baseline|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
427843|NCT00929305|B1|Baseline|Placebo Laser|inactive laser light
427844|NCT00929305|P2|Participant Flow|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
427845|NCT00929305|P1|Participant Flow|Placebo Laser|inactive laser light
427846|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
427847|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
427848|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
427849|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
427850|NCT00929305|E2|Reported Event|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
427851|NCT00929305|E1|Reported Event|Placebo Laser|inactive laser light
427899|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427900|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427852|NCT00929240|B1|Baseline|Intial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
427853|NCT00929240|P3|Participant Flow|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427854|NCT00929240|P2|Participant Flow|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (partial response [PR] or complete response [CR]) or disease stabilization (SD) received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427855|NCT00929240|P1|Participant Flow|Initial Treatment Phase: Bevacizumab Plus (+) Docetaxel|During the Initial Phase all participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 milligrams per square meter (mg/m^2) IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
427856|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
427857|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion.At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
427858|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427859|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427901|NCT00929162|E2|Reported Event|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427902|NCT00929162|E1|Reported Event|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427903|NCT00929110|B4|Baseline|Total|Total of all reporting groups
427981|NCT00928954|P2|Participant Flow|Memantine First, Then Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
427860|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427861|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427862|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427863|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427864|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427865|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427866|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427867|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427979|NCT00929071|E1|Reported Event|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
428095|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
427868|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427869|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427870|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427871|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427872|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427873|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427874|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427875|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427980|NCT00928954|B1|Baseline|All Study Participants|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
428163|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
427876|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427877|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427878|NCT00929240|E3|Reported Event|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
427879|NCT00929240|E2|Reported Event|Maintenance Phase:Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
427880|NCT00929240|E1|Reported Event|Initial Treatment Phase:Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
427881|NCT00929201|B1|Baseline|All Participants|All randomized participants
427882|NCT00929201|P2|Participant Flow|Sita/Met FDC Then Sita + Met|Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
427883|NCT00929201|P1|Participant Flow|Sita + Met Then Sita/Met FDC|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2.
427884|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
427885|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
427886|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
427887|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
427888|NCT00929201|E2|Reported Event|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
427889|NCT00929201|E1|Reported Event|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
427890|NCT00929162|B3|Baseline|Total|Total of all reporting groups
427891|NCT00929162|B2|Baseline|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427892|NCT00929162|B1|Baseline|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427893|NCT00929162|P2|Participant Flow|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427894|NCT00929162|P1|Participant Flow|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427895|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427896|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
427897|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
428096|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
427904|NCT00929110|B3|Baseline|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427905|NCT00929110|B2|Baseline|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427906|NCT00929110|B1|Baseline|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427907|NCT00929110|P3|Participant Flow|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427908|NCT00929110|P2|Participant Flow|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427909|NCT00929110|P1|Participant Flow|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427910|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427911|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427912|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427913|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427914|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427915|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427916|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427917|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427918|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427919|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427920|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427921|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
430637|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
427922|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427923|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427924|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427925|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427926|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427927|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427928|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427929|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427930|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427931|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427932|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427933|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427934|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427935|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427936|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427937|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427938|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427939|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
430638|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
427940|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427941|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427942|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427943|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427944|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427945|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427946|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427947|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427948|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427949|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427950|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427951|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427952|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427953|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427954|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427955|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427956|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427957|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
430639|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
427958|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427959|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427960|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427961|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427962|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427963|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427964|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427965|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427966|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427967|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427968|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427969|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427970|NCT00929110|E3|Reported Event|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427971|NCT00929110|E2|Reported Event|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427972|NCT00929110|E1|Reported Event|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
427973|NCT00929071|B1|Baseline|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
427974|NCT00929071|P1|Participant Flow|All Study Participants|Assess a difference in immediate post-injection pain of Evolence/topical anesthetic at the left nasolabial fold vs Evolence/Lidocaine at the right nasolabial fold.
427975|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine~collagen: Injectable collagen~Lidocaine: admix anesthetic"
427976|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic~collagen: Injectable collagen~topical anesthetic"
427977|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine right nasolabial fold~collagen: Injectable collagen~Lidocaine: admix anesthetic"
427978|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic left nasolabial fold~collagen: Injectable collagen~topical anesthetic"
428164|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
427982|NCT00928954|P1|Participant Flow|Gabapentin First and Then Memantine|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
427983|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).~memantine: increasing to 40 mg/day"
427984|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)~gabapentin: increasing to 1200 mg/day"
427985|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).~memantine: increasing to 40 mg/day"
427986|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)~gabapentin: increasing to 1200 mg/day"
427987|NCT00928954|E2|Reported Event|Memantine|Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
427988|NCT00928954|E1|Reported Event|Gabapentin|Increasing dose to 300 mg four times per day (total of 1200 mg/day)
427989|NCT00928889|B3|Baseline|Total|Total of all reporting groups
427990|NCT00928889|B2|Baseline|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
427991|NCT00928889|B1|Baseline|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
427992|NCT00928889|P2|Participant Flow|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
427993|NCT00928889|P1|Participant Flow|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
427994|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
427995|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
427996|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
427997|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
427998|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
427999|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428000|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428001|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428002|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428003|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428004|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428005|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428006|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428007|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428008|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428009|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428010|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428011|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428012|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428013|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428014|NCT00928889|E2|Reported Event|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
428015|NCT00928889|E1|Reported Event|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
428016|NCT00928772|B4|Baseline|Total|Total of all reporting groups
428017|NCT00928772|B3|Baseline|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
428018|NCT00928772|B2|Baseline|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
428019|NCT00928772|B1|Baseline|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
428020|NCT00928772|P3|Participant Flow|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
428021|NCT00928772|P2|Participant Flow|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
428022|NCT00928772|P1|Participant Flow|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
428023|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
428024|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
428025|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
428026|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
428027|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
428028|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
428029|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
428030|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
428031|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
428032|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
428033|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
428034|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
428035|NCT00928772|E3|Reported Event|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
428036|NCT00928772|E2|Reported Event|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
428037|NCT00928772|E1|Reported Event|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
428038|NCT00928746|B1|Baseline|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
428039|NCT00928746|P1|Participant Flow|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
428040|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428041|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428042|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428043|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428044|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428045|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428046|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428047|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428048|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428049|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428050|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428051|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428052|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428053|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428054|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
428055|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg - Oral inhalation) - 180 Actuations group
428056|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
428057|NCT00928746|E1|Reported Event|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
428058|NCT00928720|B4|Baseline|Total|Total of all reporting groups
428059|NCT00928720|B3|Baseline|Usual Care Alone|No intervention; participants will received usual medical care for fibromyalgia
428060|NCT00928720|B2|Baseline|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
428061|NCT00928720|B1|Baseline|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
428062|NCT00928720|P3|Participant Flow|Usual Care Alone|No intervention; usual medical care for fibromyalgia
428165|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428063|NCT00928720|P2|Participant Flow|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
428064|NCT00928720|P1|Participant Flow|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
428065|NCT00928720|O3|Outcome|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
428066|NCT00928720|O2|Outcome|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
428067|NCT00928720|O1|Outcome|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
428068|NCT00928720|E3|Reported Event|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
428069|NCT00928720|E2|Reported Event|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
428070|NCT00928720|E1|Reported Event|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
428071|NCT00928694|B1|Baseline|All Participants|
428072|NCT00928694|P2|Participant Flow|SUPRALIP™ First, Then TRICOR™|UK formulation (SUPRALIP™) 160 mg tablet / U.S. formulation (TRICOR™) 160 mg tablet
428073|NCT00928694|P1|Participant Flow|TRICOR™ First, Then SUPRALIP™|U.S. formulation (TRICOR™) 160 mg tablet/ UK formulation (SUPRALIP™) 160 mg tablet
428074|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
428075|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
428076|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
428077|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
428078|NCT00928694|E2|Reported Event|Supralip™|UK formulation (SUPRALIP™) 160 mg tablet
428079|NCT00928694|E1|Reported Event|Tricor™|U.S. formulation (TRICOR™) 160 mg tablet
428080|NCT00928668|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. 31 patients were assigned randomly to one of 5 treatment sequences in which they received each of 5 treatments. The duration of each treatment period was 1 day with a 14 day washout period between treatments.
428081|NCT00928668|P5|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg|Patients were administered matching Placebo in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
428082|NCT00928668|P4|Participant Flow|Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
428083|NCT00928668|P3|Participant Flow|Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
428084|NCT00928668|P2|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
428085|NCT00928668|P1|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
428086|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
428087|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
428088|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
428089|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
428090|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
428091|NCT00928668|O5|Outcome|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
428092|NCT00928668|O4|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
428093|NCT00928668|O3|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
428094|NCT00928668|O2|Outcome|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
428099|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
428100|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
428101|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
428102|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
428103|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
428104|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
428105|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
428106|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
428107|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
428108|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
428109|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
428110|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
428111|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
428112|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
428113|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
428114|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
428115|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
428116|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
428117|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
428118|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
428119|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
428120|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
428121|NCT00928668|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
428122|NCT00928668|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
428123|NCT00928668|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
428124|NCT00928668|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
428125|NCT00928668|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
428126|NCT00928642|B1|Baseline|Treatment|Open label, non-randomized, single treatment group.
428127|NCT00928642|P1|Participant Flow|Oral Imatinib Plus Gemcitabine|Open label, non-randomized, single treatment group.
428128|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
428129|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
428130|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
428131|NCT00928642|O1|Outcome|Oral Imatinib Plus IV Gemcitabine|Open label, non-randomized, single treatment group. all subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis that progressed after prior treatment.
428132|NCT00928642|O1|Outcome|Oral Imatinib Puls IV Gemcitabine|Open label, non-randomized, single treatment group.
428133|NCT00928642|O1|Outcome|Oral Imatinib Plus Gemcitabine|"Open label, non-randomized, single treatment group.~All subjects has measurable or evaluabel epithelial ovarian cancer or preitoneal carcinomatosis. all subjects were treated with oral imatinib and IV gemcitabine."
428134|NCT00928642|E1|Reported Event|Treatment|Open label, non-randomized, single treatment group.
428135|NCT00928512|B6|Baseline|Total|Total of all reporting groups
428136|NCT00928512|B5|Baseline|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428137|NCT00928512|B4|Baseline|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428138|NCT00928512|B3|Baseline|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428139|NCT00928512|B2|Baseline|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428140|NCT00928512|B1|Baseline|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428141|NCT00928512|P5|Participant Flow|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428142|NCT00928512|P4|Participant Flow|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428143|NCT00928512|P3|Participant Flow|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428144|NCT00928512|P2|Participant Flow|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428145|NCT00928512|P1|Participant Flow|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428146|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428147|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428148|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428149|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428150|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428151|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428152|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428153|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428154|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428155|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428156|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428157|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428158|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428159|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428160|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428161|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428162|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428166|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428167|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428168|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428169|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428170|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428171|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428172|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428173|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428174|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428175|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428176|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428177|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428178|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428179|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428180|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428181|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428182|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428183|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428184|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428185|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428186|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428187|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428188|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428189|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428190|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428191|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428192|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428193|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428194|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428195|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428196|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428197|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428198|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428199|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428200|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428201|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428202|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428203|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428204|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428205|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428206|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428207|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428208|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428209|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428210|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428211|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428212|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428213|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428214|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428215|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428216|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428217|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428218|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428219|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428220|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428221|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428222|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428223|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428224|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428225|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428226|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428227|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428228|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428229|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428230|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428231|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
428232|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
428233|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
428234|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
428235|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
428236|NCT00928512|E9|Reported Event|AIN457 300mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 300mg
428237|NCT00928512|E8|Reported Event|AIN457 150mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 150mg
428238|NCT00928512|E7|Reported Event|AIN457 75mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 75mg
428239|NCT00928512|E6|Reported Event|AIN457 25mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 25mg
428240|NCT00928512|E5|Reported Event|Placebo|Up to Week 20 - Placebo
428241|NCT00928512|E4|Reported Event|AIN457 300mg|Up to Week 20 - AIN457 300mg
428242|NCT00928512|E3|Reported Event|AIN457 150mg|Up to Week 20 - AIN457 150mg
428243|NCT00928512|E2|Reported Event|AIN457 75mg|Up to Week 20 - AIN457 75mg
428244|NCT00928512|E1|Reported Event|AIN457 25mg|Up to Week 20 - AIN457 25mg
428245|NCT00928486|B1|Baseline|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
428246|NCT00928486|P1|Participant Flow|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
428247|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
428248|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
428249|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
428250|NCT00928486|E1|Reported Event|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
428251|NCT00928434|B4|Baseline|Total|Total of all reporting groups
428252|NCT00928434|B3|Baseline|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer’s labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)"
428253|NCT00928434|B2|Baseline|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428254|NCT00928434|B1|Baseline|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428255|NCT00928434|P3|Participant Flow|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428256|NCT00928434|P2|Participant Flow|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428375|NCT00928304|O1|Outcome|Majority Read|Majority read of the visual assessment made by 3 independent readers of PET images from all subjects.
428376|NCT00928304|E2|Reported Event|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
428377|NCT00928304|E1|Reported Event|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
428257|NCT00928434|P1|Participant Flow|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428258|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428259|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428260|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428261|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428262|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428263|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428264|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428265|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428378|NCT00928252|B1|Baseline|Single Arm|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
428379|NCT00928252|P1|Participant Flow|Received 18F-fluorocholine PET/CT|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
429215|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
428266|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428267|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428268|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428269|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428270|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428271|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428272|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428273|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428274|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428275|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428276|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428277|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428380|NCT00928252|O1|Outcome|Positive Metabolically Active Tumor Response|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation. Positive Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
428457|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
428278|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428279|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428280|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428281|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428282|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428283|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428284|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428285|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428286|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428287|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428288|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428289|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428381|NCT00928252|O1|Outcome|Received 18F-fluorocholine PET/CT|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV)."
428458|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
428290|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428291|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428292|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428293|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428294|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428295|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428296|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428297|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428298|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428299|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428300|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428301|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428382|NCT00928252|O1|Outcome|Received 18F-fluorocholine PET/CT|"IV fluorine-18 labeled methylcholine before PET/CT~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
428383|NCT00928252|E1|Reported Event|Single Arm|"18F-fluoromethylcholine IV in conjunction with PET/CT imaging~IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation."
428302|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428303|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428304|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428305|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428306|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
428307|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428308|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428309|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428310|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
428311|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428312|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428313|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428384|NCT00928187|B4|Baseline|Total|Total of all reporting groups
428385|NCT00928187|B3|Baseline|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428459|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
428314|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
428315|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428316|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428317|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428318|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428319|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428320|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428321|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428322|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428323|NCT00928434|O2|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
428324|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428325|NCT00928434|E3|Reported Event|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
428326|NCT00928434|E2|Reported Event|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
428327|NCT00928434|E1|Reported Event|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
428328|NCT00928421|B1|Baseline|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
428329|NCT00928421|P1|Participant Flow|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
428330|NCT00928421|O1|Outcome|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
428331|NCT00928421|E1|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
428332|NCT00928408|B1|Baseline|Cinacalcet|
428333|NCT00928408|P1|Participant Flow|Cinacalcet|
428334|NCT00928408|O1|Outcome|Cinacalcet|
428335|NCT00928408|O1|Outcome|Cinacalcet|
428336|NCT00928408|O1|Outcome|Cinacalcet|
428337|NCT00928408|O1|Outcome|Cinacalcet|
428338|NCT00928408|O1|Outcome|Cinacalcet|
428339|NCT00928408|O1|Outcome|Cinacalcet|
428340|NCT00928408|O1|Outcome|Cinacalcet|
428341|NCT00928408|O1|Outcome|Cinacalcet|
428342|NCT00928408|O1|Outcome|Cinacalcet|
428343|NCT00928408|O1|Outcome|Cinacalcet|
428344|NCT00928408|O1|Outcome|Cinacalcet|
428345|NCT00928408|O1|Outcome|Cinacalcet|
428346|NCT00928408|O1|Outcome|Cinacalcet|
428347|NCT00928408|O1|Outcome|Cinacalcet|
428348|NCT00928408|O1|Outcome|Cinacalcet|
428349|NCT00928408|O1|Outcome|Cinacalcet|
428350|NCT00928408|O1|Outcome|Cinacalcet|
428351|NCT00928408|O1|Outcome|Cinacalcet|
428352|NCT00928408|O1|Outcome|Cinacalcet|
428353|NCT00928408|O1|Outcome|Cinacalcet|
428354|NCT00928408|O1|Outcome|Cinacalcet|
428355|NCT00928408|O1|Outcome|Cinacalcet|
428356|NCT00928408|O1|Outcome|Cinacalcet|
428357|NCT00928408|O1|Outcome|Cinacalcet|
428358|NCT00928408|O1|Outcome|Cinacalcet|
428359|NCT00928408|O1|Outcome|Cinacalcet|
428360|NCT00928408|E1|Reported Event|Cinacalcet|
428361|NCT00928395|B1|Baseline|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
428362|NCT00928395|P1|Participant Flow|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
428363|NCT00928395|O1|Outcome|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
428364|NCT00928395|E1|Reported Event|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
428365|NCT00928304|B1|Baseline|Subjects Enrolled in Study|All Down Syndrome and healthy volunteer subjects
428366|NCT00928304|P2|Participant Flow|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
428367|NCT00928304|P1|Participant Flow|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172) : 300 megabecquerels (MBq) single IV injection of 2 to 10 mL
428368|NCT00928304|O3|Outcome|Healthy Volunteer Group|All healthy volunteers enrolled in the study
428369|NCT00928304|O2|Outcome|Down Syndrome PET-negative (Majority Read)|Down Syndrome subjects negative for cerebral beta-amyloid as determined by majority read
428370|NCT00928304|O1|Outcome|Down Syndrome PET-positive (Majority Read)|Down Syndrome subjects positive for cerebral beta-amyloid as determined by majority read
428371|NCT00928304|O2|Outcome|Healthy Volunteer Group|Healthy volunteers enrolled in the study
428372|NCT00928304|O1|Outcome|Down Syndrome Group|Subjects with Down Syndrome enrolled in the study
428373|NCT00928304|O2|Outcome|Majority Read (DS-Old)|Majority Read results for Down Syndrome subjects with age >46 yrs
428374|NCT00928304|O1|Outcome|Majority Read (DS-Young)|Majority Read results for Down Syndrome subjects with age <= 46 yrs
429216|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
428386|NCT00928187|B2|Baseline|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428387|NCT00928187|B1|Baseline|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428388|NCT00928187|P3|Participant Flow|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428389|NCT00928187|P2|Participant Flow|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428390|NCT00928187|P1|Participant Flow|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428391|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428392|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428393|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428394|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428395|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428396|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428397|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428398|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428399|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428400|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428401|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428402|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428403|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428404|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428455|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428405|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428406|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428407|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428408|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428409|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428410|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428411|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428412|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428413|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428414|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428415|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428416|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428417|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428418|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428419|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428420|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428421|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428422|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428423|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428456|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
428701|NCT00927927|B10|Baseline|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
428424|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428425|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428426|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428427|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428428|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428429|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428430|NCT00928187|E3|Reported Event|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
428431|NCT00928187|E2|Reported Event|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
428432|NCT00928187|E1|Reported Event|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
428433|NCT00928174|B1|Baseline|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
428434|NCT00928174|P1|Participant Flow|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
428435|NCT00928174|O1|Outcome|Single Arm|"fluourine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 fluoromethylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
428436|NCT00928174|E1|Reported Event|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
428437|NCT00928083|B4|Baseline|Total|Total of all reporting groups
428438|NCT00928083|B3|Baseline|Part C - OZ439 Multiple Rising Dose|Subjects were assigned to individual dose cohorts (200, 400 and 800 mg OZ439) and placebo.
428439|NCT00928083|B2|Baseline|Part B - OZ439 Food Effect|"Subjects were randomized to sequence groups, fasted/fed or fed/fasted while receiving a single dose of 800 mg OZ439."
428440|NCT00928083|B1|Baseline|Part A - OZ439 Single Rising Dose|Included 3 Cohorts, where subjects in cohorts 1 and 2 were randomized to a treatment sequence, receiving doses of OZ439 on four occasions and placebo on one occasion, and subjects in Cohort 3 were administered increasing doses of the oral dispersion.
428441|NCT00928083|P9|Participant Flow|Part C - Placebo|Part C - Placebo
428442|NCT00928083|P8|Participant Flow|Part C - 800mg OZ439 Multiple Dose|OZ439 800mg for 3 consecutive days
428443|NCT00928083|P7|Participant Flow|Part C - 400mg OZ439 Multiple Dose|OZ439 400mg for 3 consecutive days
428444|NCT00928083|P6|Participant Flow|Part C - 200mg OZ439 Multiple Dose|200mg OZ439 for 3 consecutive days
428445|NCT00928083|P5|Participant Flow|Part B - Food Effect - Cohort 2|Food Effect - Cohort 2 800mg OZ439 Fed then Fasted
428446|NCT00928083|P4|Participant Flow|Part B - Food Effect - Cohort 1|Food Effect - Cohort 1 800mg OZ439 Fasted then Fed
428447|NCT00928083|P3|Participant Flow|Part A - OZ439 Single Dose - Cohort 3|Oral Dispersion OZ439 50-1600 mg
428448|NCT00928083|P2|Participant Flow|Part A - OZ439 Single Dose - Cohort 2|OZ439 50 mg, then 100 mg, then 400 mg, then 1200 mg, then Placebo
428449|NCT00928083|P1|Participant Flow|Part A - OZ439 Single Dose - Cohort 1|OZ439 50 mg then 200 mg, then 800 mg, then 1600 mg, then Placebo
428450|NCT00928083|O3|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428451|NCT00928083|O2|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428452|NCT00928083|O1|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428453|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428454|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428460|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
428461|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
428462|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
428463|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428464|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
428465|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
428466|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
428467|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428468|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428469|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428470|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
428471|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
428472|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
428473|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
428474|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
428475|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
428476|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
428477|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428478|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
428479|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
428480|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
428481|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428482|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428483|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428484|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
428485|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
428486|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
428487|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
428488|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
428489|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
428490|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
428491|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428492|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
428493|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
428494|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
428495|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428496|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428497|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428498|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
428499|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
428500|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
428501|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
428502|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
428503|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
428504|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
428505|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428506|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
428507|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
428508|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
428509|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428510|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428511|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428512|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
428513|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
428514|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
428515|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
428516|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
428517|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
428518|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
428519|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428520|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
428521|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
428522|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
428523|NCT00928083|O17|Outcome|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
428524|NCT00928083|O16|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428525|NCT00928083|O15|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428526|NCT00928083|O14|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428527|NCT00928083|O13|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
428528|NCT00928083|O12|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
428529|NCT00928083|O11|Outcome|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
428530|NCT00928083|O10|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
428531|NCT00928083|O9|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
428532|NCT00928083|O8|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
428533|NCT00928083|O7|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
428534|NCT00928083|O6|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
428535|NCT00928083|O5|Outcome|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428536|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428537|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
428538|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
428539|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
428540|NCT00928083|E17|Reported Event|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
428541|NCT00928083|E16|Reported Event|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
428542|NCT00928083|E15|Reported Event|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
428543|NCT00928083|E14|Reported Event|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
428544|NCT00928083|E13|Reported Event|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
428545|NCT00928083|E12|Reported Event|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
428546|NCT00928083|E11|Reported Event|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
428547|NCT00928083|E10|Reported Event|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
428548|NCT00928083|E9|Reported Event|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
428549|NCT00928083|E8|Reported Event|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
428702|NCT00927927|B9|Baseline|SD Placebo|Subjects were dosed once with placebo
428550|NCT00928083|E7|Reported Event|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
428551|NCT00928083|E6|Reported Event|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
428552|NCT00928083|E5|Reported Event|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428553|NCT00928083|E4|Reported Event|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
428554|NCT00928083|E3|Reported Event|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
428555|NCT00928083|E2|Reported Event|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
428556|NCT00928083|E1|Reported Event|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
428557|NCT00928070|B3|Baseline|Total|Total of all reporting groups
428558|NCT00928070|B2|Baseline|Fesoterodine|Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428559|NCT00928070|B1|Baseline|Placebo|Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428560|NCT00928070|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428561|NCT00928070|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428562|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428563|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428564|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428565|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428566|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428567|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428568|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428569|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428570|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428571|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428572|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428573|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428574|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428575|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428576|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428577|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428578|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428579|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428580|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428581|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428703|NCT00927927|B8|Baseline|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
428582|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428583|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428584|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428585|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428586|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428587|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428588|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428589|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428590|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428591|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428592|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428593|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428594|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428595|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428596|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428597|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428598|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428599|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428600|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428601|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428602|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428603|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428604|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428605|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428606|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428607|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428608|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428609|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428610|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428611|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428612|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428613|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428614|NCT00928070|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
428615|NCT00928070|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
428616|NCT00928057|B3|Baseline|Total|Total of all reporting groups
428617|NCT00928057|B2|Baseline|4 mm / 5 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 5 mm pen needles, regardless of whether they completed the study.
428618|NCT00928057|B1|Baseline|4 mm / 8 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 8 mm pen needles, regardless of whether they completed the study.
428619|NCT00928057|P2|Participant Flow|4 mm / 5 mm PN|This group represents all subjects that were randomized to compare the 4mm and 5mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
428620|NCT00928057|P1|Participant Flow|4 mm / 8 mm PN|This group represents all subjects that were randomized to compare the 4mm and 8mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
428621|NCT00928057|O3|Outcome|8 mm PN|Use of 8 mm PN for insulin injections for 3 weeks.
428622|NCT00928057|O2|Outcome|5 mm PN|Use of 5 mm PN for insulin injections for 3 weeks.
428623|NCT00928057|O1|Outcome|4 mm PN|Use of 4 mm PN for insulin injections for 3 weeks.
428624|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
428625|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
428626|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN
428627|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN
428628|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN
428629|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
428630|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
428631|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
428632|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
428633|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
428634|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
428635|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
428636|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
428637|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
428638|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
428639|NCT00928057|E3|Reported Event|4mm PN|All randomized subjects that used the 4mm pen needle.
428640|NCT00928057|E2|Reported Event|5mm PN|All randomized subjects that used the 5 mm pen needle.
428641|NCT00928057|E1|Reported Event|8mm PN|All randomized subjects that used the 8 mm pen needle.
428642|NCT00928018|B3|Baseline|Total|Total of all reporting groups
428643|NCT00928018|B2|Baseline|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428644|NCT00928018|B1|Baseline|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428704|NCT00927927|B7|Baseline|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
428705|NCT00927927|B6|Baseline|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
428706|NCT00927927|B5|Baseline|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
428707|NCT00927927|B4|Baseline|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
428708|NCT00927927|B3|Baseline|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
428709|NCT00927927|B2|Baseline|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
428645|NCT00928018|P2|Participant Flow|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428646|NCT00928018|P1|Participant Flow|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428647|NCT00928018|O4|Outcome|Aggressive Group: Sirolimus-Free Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
428648|NCT00928018|O3|Outcome|Aggressive Group: Sirolimus-Containing Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
428649|NCT00928018|O2|Outcome|Indolent Group: Sirolimus-Free Regimen|"Indolent group: indolent B-cell NHL, CLL and HL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
428650|NCT00928018|O1|Outcome|Indolent Group: Sirolimus-Containing Regimen|"Indolent group:indolent B-cell NHL, CLL and HL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
428651|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428652|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428710|NCT00927927|B1|Baseline|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
428711|NCT00927927|P15|Participant Flow|MD Placebo|Subjects were injected biweekly four times with placebo
428712|NCT00927927|P14|Participant Flow|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
428713|NCT00927927|P13|Participant Flow|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
428714|NCT00927927|P12|Participant Flow|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
428653|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428654|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428655|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428656|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428657|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428658|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428659|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428660|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428715|NCT00927927|P11|Participant Flow|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
428716|NCT00927927|P10|Participant Flow|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
428717|NCT00927927|P9|Participant Flow|SD Placebo|Subjects were dosed once with placebo
428718|NCT00927927|P8|Participant Flow|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
428719|NCT00927927|P7|Participant Flow|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
429301|NCT00927069|B3|Baseline|Total|Total of all reporting groups
428661|NCT00928018|E2|Reported Event|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
428662|NCT00928018|E1|Reported Event|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
428663|NCT00927992|B1|Baseline|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428664|NCT00927992|P1|Participant Flow|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428665|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428666|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428667|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428668|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428669|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428670|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428671|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428672|NCT00927992|E1|Reported Event|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
428673|NCT00927953|B3|Baseline|Total|Total of all reporting groups
428674|NCT00927953|B2|Baseline|Placebo - Normal Saline|single intravenous infusion of saline placebo
428675|NCT00927953|B1|Baseline|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428676|NCT00927953|P2|Participant Flow|Placebo - Normal Saline|single intravenous infusion of saline placebo
428677|NCT00927953|P1|Participant Flow|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428678|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
428679|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428680|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
428681|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428682|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
428683|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428684|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
428685|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428686|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
428687|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428688|NCT00927953|E2|Reported Event|Placebo - Normal Saline|single intravenous infusion of saline placebo
428689|NCT00927953|E1|Reported Event|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
428690|NCT00927940|B1|Baseline|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
428691|NCT00927940|P1|Participant Flow|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
428692|NCT00927940|O1|Outcome|Zotarolims Eluting Stent|
428693|NCT00927940|O1|Outcome|Zotarolimus Eluting Stent|100 lesion of 100 ITT patients were subjected for this analysis.
428694|NCT00927940|E1|Reported Event|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
428695|NCT00927927|B16|Baseline|Total|Total of all reporting groups
428696|NCT00927927|B15|Baseline|MD Placebo|Subjects were injected biweekly four times with placebo
428697|NCT00927927|B14|Baseline|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
428698|NCT00927927|B13|Baseline|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
428699|NCT00927927|B12|Baseline|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
428700|NCT00927927|B11|Baseline|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
428720|NCT00927927|P6|Participant Flow|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
428721|NCT00927927|P5|Participant Flow|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
428722|NCT00927927|P4|Participant Flow|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
428723|NCT00927927|P3|Participant Flow|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
428724|NCT00927927|P2|Participant Flow|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
428725|NCT00927927|P1|Participant Flow|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
428726|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
428727|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
428728|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
428729|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
428730|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
428731|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
428732|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
428733|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
428734|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
428735|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
428736|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
428737|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
428738|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
428739|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
428740|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
428741|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
428742|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
428743|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
428744|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
428745|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
428746|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
428747|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
428748|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
428749|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
428750|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
428751|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
428752|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
428753|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
428754|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
428755|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
428756|NCT00927927|E15|Reported Event|MD Placebo|Subjects were injected biweekly four times with placebo
428757|NCT00927927|E14|Reported Event|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
428758|NCT00927927|E13|Reported Event|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
428759|NCT00927927|E12|Reported Event|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
428760|NCT00927927|E11|Reported Event|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
428761|NCT00927927|E10|Reported Event|SD Placebo|Subjects were dosed once with placebo
428762|NCT00927927|E9|Reported Event|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
428763|NCT00927927|E8|Reported Event|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
428764|NCT00927927|E7|Reported Event|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
428765|NCT00927927|E6|Reported Event|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
428766|NCT00927927|E5|Reported Event|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
428767|NCT00927927|E4|Reported Event|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
428768|NCT00927927|E3|Reported Event|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
428769|NCT00927927|E2|Reported Event|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
428770|NCT00927927|E1|Reported Event|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
428771|NCT00927901|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received the 3 salt forms of indacaterol 400 µg (maleate, acetate, and xinafoate) and placebo to indacaterol in 4 different sequences. The dose refers to 400 μg of free base indacaterol. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428772|NCT00927901|P4|Participant Flow|Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate|In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428773|NCT00927901|P3|Participant Flow|Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate|In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428774|NCT00927901|P2|Participant Flow|Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo|In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428775|NCT00927901|P1|Participant Flow|Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate|In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428776|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428777|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428778|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428779|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428780|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428781|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428782|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428783|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428784|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|3Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428785|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428786|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428787|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428788|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428789|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428790|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428791|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428792|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428793|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428794|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428795|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428796|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428797|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428798|NCT00927901|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428799|NCT00927901|E3|Reported Event|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428800|NCT00927901|E2|Reported Event|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428801|NCT00927901|E1|Reported Event|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
428802|NCT00927888|B3|Baseline|Total|Total of all reporting groups
428803|NCT00927888|B2|Baseline|Group 2 - Saline Placebo Group|Saline substituted in block, placebo treatment group with application of saline block before FESS.
428804|NCT00927888|B1|Baseline|Group 1 Bupivacaine|Active treatment group with application of bupivacaine block before FESS.
428805|NCT00927888|P2|Participant Flow|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
428806|NCT00927888|P1|Participant Flow|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
428807|NCT00927888|O2|Outcome|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
428808|NCT00927888|O1|Outcome|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
428809|NCT00927888|O2|Outcome|2 - Placebo|Normal saline with Epi 1:100,000 (B block)
428810|NCT00927888|O1|Outcome|1 - Bupivacaine Block|"3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)~Bupivacaine Block: Bupivacaine local anesthesia block prior to start of FESS procedure."
428811|NCT00927888|E2|Reported Event|Group 2 - Saline Placebo Block|Placebo treatment group with application of saline block before FESS.
428812|NCT00927888|E1|Reported Event|Group 1 - Bupicaine Block|Active treatment group with application of bupivacaine block before FESS.
428813|NCT00927862|B3|Baseline|Total|Total of all reporting groups
428814|NCT00927862|B2|Baseline|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
428815|NCT00927862|B1|Baseline|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
428816|NCT00927862|P2|Participant Flow|Parellel/Historical Controls|A parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized pharmacogenetic-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified.
428817|NCT00927862|P1|Participant Flow|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms were randomized to receive either standard or modified International Warfarin Pharmacogenetics Consortium [IWPC] warfarin dosing. The IWPC derived and published a common algorithm to predict stable maintenance dose based on ~5000 patients across broad geographic and ethnic/racial groups (N Engl J Med 2009;360:753-764). Hence, we based our standard algorithm on the IWPC algorithm with minor modifications to accommodate different INR targets and smoking status, based on supplemental data from Gage et al (Clini Pharmacol Ther 2008;84:326 -331). The modified IWPC algorithm included 2 further modifications: (1) It ignored the CYP2C9 variant status for the first 2 days; and (2) It used a special dose-revision algorithm based on a day 4 (or day 5) INR after 3 (or 4) warfarin doses.
428818|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
428819|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
428820|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
428821|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
428822|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
428823|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
428824|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
428825|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
428826|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
428827|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
428828|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
428829|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
428830|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
428831|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
428832|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
428833|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
428834|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
428835|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
428836|NCT00927862|E2|Reported Event|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
428837|NCT00927862|E1|Reported Event|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
428838|NCT00927849|B4|Baseline|Total|Total of all reporting groups
428839|NCT00927849|B3|Baseline|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
428840|NCT00927849|B2|Baseline|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
428841|NCT00927849|B1|Baseline|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
428842|NCT00927849|P3|Participant Flow|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
428843|NCT00927849|P2|Participant Flow|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
428844|NCT00927849|P1|Participant Flow|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
428845|NCT00927849|O3|Outcome|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
428846|NCT00927849|O2|Outcome|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
428847|NCT00927849|O1|Outcome|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
428848|NCT00927849|E3|Reported Event|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
428849|NCT00927849|E2|Reported Event|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
428850|NCT00927849|E1|Reported Event|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
428851|NCT00927823|B1|Baseline|Entire Study Population|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428852|NCT00927823|P4|Participant Flow|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428853|NCT00927823|P3|Participant Flow|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428854|NCT00927823|P2|Participant Flow|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428855|NCT00927823|P1|Participant Flow|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428856|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428857|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428858|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428859|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428860|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428861|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428862|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428863|NCT00927823|O2|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428864|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428865|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428866|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428867|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428868|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428869|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428870|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428871|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428872|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428873|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428874|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428961|NCT00927563|B1|Baseline|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
428875|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428876|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428877|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428878|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428879|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428880|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428881|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428882|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428883|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428884|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428885|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428886|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428887|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428888|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428889|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 11 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
428890|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 8 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
428891|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 4 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
428892|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 2 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
428893|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428894|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428895|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428896|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428962|NCT00927563|P1|Participant Flow|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
428963|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
428897|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428898|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428899|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428900|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428901|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428902|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428903|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428904|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428905|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428906|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428907|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428908|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428909|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428910|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428911|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428912|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428913|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428914|NCT00927823|E4|Reported Event|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428915|NCT00927823|E3|Reported Event|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428916|NCT00927823|E2|Reported Event|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428917|NCT00927823|E1|Reported Event|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
428918|NCT00927758|B1|Baseline|All Randomized Patients|Baseline measured for all randomized (safety set) patients.
428919|NCT00927758|P6|Participant Flow|Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
428920|NCT00927758|P5|Participant Flow|Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
428921|NCT00927758|P4|Participant Flow|Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
428922|NCT00927758|P3|Participant Flow|Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
428923|NCT00927758|P2|Participant Flow|Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
428924|NCT00927758|P1|Participant Flow|Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
428925|NCT00927758|O3|Outcome|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
428926|NCT00927758|O2|Outcome|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
428927|NCT00927758|O1|Outcome|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
428928|NCT00927758|E3|Reported Event|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
428929|NCT00927758|E2|Reported Event|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
428930|NCT00927758|E1|Reported Event|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
428931|NCT00927589|B1|Baseline|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428932|NCT00927589|P1|Participant Flow|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 milligrams per kilogram (mg/kg) of body weight given by intravenous (IV) infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 milligrams per square meter (mg/m^2) of body surface area (BSA) on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target area under the concentration-versus-time curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428933|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428934|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
429336|NCT00926887|O1|Outcome|Placebo Laser|inactive light
428935|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428936|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428937|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428938|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428939|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428940|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428941|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428942|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428943|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428944|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428964|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
428965|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
428945|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428946|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428947|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428948|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428949|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428950|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428951|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428952|NCT00927589|E1|Reported Event|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
428953|NCT00927576|B3|Baseline|Total|Total of all reporting groups
428954|NCT00927576|B2|Baseline|TBI Patients|TBI patients N = 30. Mixed mild and severe TBI group, with most showing PTSD comorbidity.
428955|NCT00927576|B1|Baseline|Control Subjects|Control subjects = 230. Normal control subjects of various ages.
428956|NCT00927576|P2|Participant Flow|TBI Patients|TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
428957|NCT00927576|P1|Participant Flow|Control Subjects|Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
428958|NCT00927576|O1|Outcome|Simple Reaction Time Test|time to respond in ms to visual stimuli presented randomly to the left or right hemifield at varying stimulus onset asynchronies.
428959|NCT00927576|E2|Reported Event|TBI Patients|TBI patients N = 28. No adverse events were observed
428960|NCT00927576|E1|Reported Event|Control Subjects|Control subjects = 237. No adverse events were observed.
430640|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
428966|NCT00927563|E1|Reported Event|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
428967|NCT00927472|B3|Baseline|Total|Total of all reporting groups
428968|NCT00927472|B2|Baseline|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428969|NCT00927472|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428970|NCT00927472|P2|Participant Flow|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428971|NCT00927472|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428972|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428973|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428974|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428975|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428976|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428977|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428978|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428979|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428980|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428981|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428982|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428983|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428984|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428985|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428986|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428987|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428988|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428989|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428990|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428991|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428992|NCT00927472|E2|Reported Event|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
428993|NCT00927472|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
428994|NCT00927394|B3|Baseline|Total|Total of all reporting groups
428995|NCT00927394|B2|Baseline|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
428996|NCT00927394|B1|Baseline|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429051|NCT00927355|P1|Participant Flow|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
428997|NCT00927394|P2|Participant Flow|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
428998|NCT00927394|P1|Participant Flow|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
428999|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429000|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429001|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429002|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429003|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429004|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429005|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429006|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429007|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429008|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429009|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429010|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429011|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429012|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429013|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429014|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429015|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429016|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429017|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429018|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429019|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429020|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429021|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429022|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
429023|NCT00927394|E2|Reported Event|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
429024|NCT00927394|E1|Reported Event|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.
429025|NCT00927368|B4|Baseline|Total|Total of all reporting groups
429026|NCT00927368|B3|Baseline|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
429027|NCT00927368|B2|Baseline|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
429052|NCT00927355|O4|Outcome|Placebo - Lumbar Spine BMD|The other half will be randomized to placebo.
429028|NCT00927368|B1|Baseline|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
429029|NCT00927368|P3|Participant Flow|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
429030|NCT00927368|P2|Participant Flow|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
429031|NCT00927368|P1|Participant Flow|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
429032|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
429033|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
429034|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
429035|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
429036|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
429037|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
430641|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
429038|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
429039|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
429040|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
429041|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
429042|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
429043|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
429044|NCT00927368|E3|Reported Event|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
429045|NCT00927368|E2|Reported Event|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
429046|NCT00927368|E1|Reported Event|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
429047|NCT00927355|B3|Baseline|Total|Total of all reporting groups
429048|NCT00927355|B2|Baseline|Placebo|The other half will be randomized to placebo.
429049|NCT00927355|B1|Baseline|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
429050|NCT00927355|P2|Participant Flow|Placebo|The other half will be randomized to placebo, starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
429427|NCT00926393|B2|Baseline|Quetiapine XR|Quetiapine fumarate Extended Release
429053|NCT00927355|O3|Outcome|Pioglitazone -Lumbar Spine BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
429054|NCT00927355|O2|Outcome|Placebo-Femoral Neck BMD|The other half will be randomized to placebo.
429055|NCT00927355|O1|Outcome|Pioglitazone-Femoral Neck BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
429056|NCT00927355|O6|Outcome|Placebo - Osc|serum Osteocalcin percent change 6 mo after placebo Rx compared to baseline.
429057|NCT00927355|O5|Outcome|Pioglitazone-OSc|serum Osteocalcin percent change 6 mo after pioglitazone Rx compared to baseline.
429058|NCT00927355|O4|Outcome|Placebo-CTX|serum CTX percent change 6 mo after placebo Rx compared to baseline.
429059|NCT00927355|O3|Outcome|Pioglitazone-CTX|serum CTX percent change 6 mo after pioglitazone Rx compared to baseline.
429060|NCT00927355|O2|Outcome|Placebo-Adiponectin|serum adiponectin percent change 6 mo after placebo Rx compared to baseline.
429061|NCT00927355|O1|Outcome|Pioglitazone-Adiponectin|serum adiponectin percent change 6 mo after study drug Rx compared to baseline.
429062|NCT00927355|O4|Outcome|Placebo-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O, at baseline and 6 months after treatment with study drug.
429063|NCT00927355|O3|Outcome|Pioglitazone-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O at baseline and 6 months after treatment with study drug.
429064|NCT00927355|O2|Outcome|Placebo-OSteoblast CFU|Percent change in Osteoblast CFU numbers as stained with Alizarin at baseline and 6 months after treatment with study drug.
429065|NCT00927355|O1|Outcome|Pioglitazone-Osteoblast CFU (Colony Forming Units)|Percent change in Osteoblast CFU numbers as stained with Alizarin red S at baseline and 6 months after treatment with study drug.
429066|NCT00927355|E2|Reported Event|Placebo|The other half will be randomized to placebo.
429067|NCT00927355|E1|Reported Event|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
429068|NCT00927264|B3|Baseline|Total|Total of all reporting groups
429069|NCT00927264|B2|Baseline|Education Only|"Caregivers will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429070|NCT00927264|B1|Baseline|Behavioral|"Motivational Interviewing Intervention Plus Education~Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429071|NCT00927264|P2|Participant Flow|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429072|NCT00927264|P1|Participant Flow|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429073|NCT00927264|O2|Outcome|Education Only|"Caregivers will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429074|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education~Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429075|NCT00927264|O2|Outcome|Education Only|"Caregivers will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429076|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education~Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429210|NCT00927160|B1|Baseline|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
429211|NCT00927160|P2|Participant Flow|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
429077|NCT00927264|O2|Outcome|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429078|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429079|NCT00927264|O2|Outcome|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429080|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429081|NCT00927264|O2|Outcome|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429082|NCT00927264|O1|Outcome|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429083|NCT00927264|E2|Reported Event|Education Only|"Participants will receive only educational program for ETS reduction.~Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure."
429084|NCT00927264|E1|Reported Event|Behavioral|"Motivational Interviewing Intervention Plus Education~Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.~Motivational Interviewing Intervention for ETS Reduction: The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so."
429085|NCT00927251|B1|Baseline|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
429086|NCT00927251|P1|Participant Flow|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
429087|NCT00927251|O1|Outcome|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
429088|NCT00927251|E1|Reported Event|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
429089|NCT00927186|B3|Baseline|Total|Total of all reporting groups
429212|NCT00927160|P1|Participant Flow|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
429090|NCT00927186|B2|Baseline|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429091|NCT00927186|B1|Baseline|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429092|NCT00927186|P2|Participant Flow|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429093|NCT00927186|P1|Participant Flow|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429094|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429095|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429096|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429097|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429098|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429099|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429100|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429101|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429102|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429103|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429104|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429105|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429106|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429107|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429108|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429109|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429110|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429111|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429112|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429213|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
429214|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
429113|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429114|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429115|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429116|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429117|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429118|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429119|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429120|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429121|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429122|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429123|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429124|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429125|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429126|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429127|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429128|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429129|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429130|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429131|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429132|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429133|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429134|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429135|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429136|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429137|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429138|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429139|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429140|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429141|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429142|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429143|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429144|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429145|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429146|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429147|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429148|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429149|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429150|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429151|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429152|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429153|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429154|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429155|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429156|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429157|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429158|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429159|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429160|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension"
429161|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429162|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429163|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429164|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429165|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429166|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429167|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429168|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429169|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429170|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429171|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429172|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429173|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429174|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429175|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429176|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429177|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429178|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429179|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429180|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429181|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429182|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429183|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429184|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429185|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429186|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429187|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429188|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429189|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429190|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429191|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429192|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429193|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429194|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429195|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429196|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429197|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429198|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429199|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429200|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429201|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429202|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429203|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
429204|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429205|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429206|NCT00927186|E2|Reported Event|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429207|NCT00927186|E1|Reported Event|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
429208|NCT00927160|B3|Baseline|Total|Total of all reporting groups
429209|NCT00927160|B2|Baseline|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
430642|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
429217|NCT00927160|E2|Reported Event|Usual Care|Matching group of patients admitted to general medical service
429218|NCT00927160|E1|Reported Event|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
429219|NCT00927095|B4|Baseline|Total|Total of all reporting groups
429220|NCT00927095|B3|Baseline|Continuous Placebo|"continuous placebo~placebo: daily"
429221|NCT00927095|B2|Baseline|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
429222|NCT00927095|B1|Baseline|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
429223|NCT00927095|P3|Participant Flow|Continuous Placebo|"continuous placebo~placebo: daily"
429224|NCT00927095|P2|Participant Flow|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
429225|NCT00927095|P1|Participant Flow|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
429226|NCT00927095|O3|Outcome|Continuous Placebo|"continuous placebo~placebo: daily"
429227|NCT00927095|O2|Outcome|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
429228|NCT00927095|O1|Outcome|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
429229|NCT00927095|E3|Reported Event|Continuous Placebo|"continuous placebo~placebo: daily"
429230|NCT00927095|E2|Reported Event|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
429231|NCT00927095|E1|Reported Event|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
429232|NCT00927082|B5|Baseline|Total|Total of all reporting groups
429233|NCT00927082|B4|Baseline|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429234|NCT00927082|B3|Baseline|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429235|NCT00927082|B2|Baseline|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429236|NCT00927082|B1|Baseline|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429237|NCT00927082|P4|Participant Flow|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429238|NCT00927082|P3|Participant Flow|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429239|NCT00927082|P2|Participant Flow|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429240|NCT00927082|P1|Participant Flow|PEG-IFN 90mcg 24 Wks|Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
429241|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429242|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429243|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429244|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429245|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429246|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429247|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429248|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429249|NCT00927082|O4|Outcome|Group D|Participants received 180 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429250|NCT00927082|O3|Outcome|Group C|Participants received 90 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429251|NCT00927082|O2|Outcome|Group B|Participants received 180 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429252|NCT00927082|O1|Outcome|Group A|Participants received 90 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429253|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429254|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429255|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429256|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429257|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429258|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429428|NCT00926393|B1|Baseline|Quetiapine IR|Quetiapine fumarate Immediate Release
429259|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429260|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429261|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429262|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429263|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429264|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429265|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429266|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429267|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429268|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429269|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429270|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429271|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429272|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429273|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429274|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429275|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429276|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429277|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429278|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429279|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429280|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429281|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429282|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429283|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429284|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429285|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429286|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429287|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429288|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429289|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429290|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429291|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429292|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429293|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429294|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429295|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429296|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429297|NCT00927082|E4|Reported Event|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429298|NCT00927082|E3|Reported Event|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
429299|NCT00927082|E2|Reported Event|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429300|NCT00927082|E1|Reported Event|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
429302|NCT00927069|B2|Baseline|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
429303|NCT00927069|B1|Baseline|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
429304|NCT00927069|P4|Participant Flow|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
429305|NCT00927069|P3|Participant Flow|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
429306|NCT00927069|P2|Participant Flow|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
429307|NCT00927069|P1|Participant Flow|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
429308|NCT00927069|O2|Outcome|Group B|Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
429309|NCT00927069|O1|Outcome|Group A|Patients at screening had shown an unsastifactory response after 3 months of etanercept 50mg twice a week.
429310|NCT00927069|O1|Outcome|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
429311|NCT00927069|O1|Outcome|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
429312|NCT00927069|O1|Outcome|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
429313|NCT00927069|O1|Outcome|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
429314|NCT00927069|E2|Reported Event|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
429315|NCT00927069|E1|Reported Event|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening.
429316|NCT00926952|B1|Baseline|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429317|NCT00926952|P1|Participant Flow|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429318|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429319|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429320|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429321|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429322|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429323|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429324|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429325|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429326|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429327|NCT00926952|E1|Reported Event|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
429328|NCT00926887|B3|Baseline|Total|Total of all reporting groups
429329|NCT00926887|B2|Baseline|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
429330|NCT00926887|B1|Baseline|Placebo Laser|inactive light
429331|NCT00926887|P2|Participant Flow|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
429332|NCT00926887|P1|Participant Flow|Placebo Laser|inactive light
429333|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
429334|NCT00926887|O1|Outcome|Placebo Laser|inactive light
429335|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
429337|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
429338|NCT00926887|O1|Outcome|Placebo Laser|inactive light
429339|NCT00926887|E2|Reported Event|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
429340|NCT00926887|E1|Reported Event|Placebo Laser|inactive light
429341|NCT00926796|B3|Baseline|Total|Total of all reporting groups
429342|NCT00926796|B2|Baseline|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429343|NCT00926796|B1|Baseline|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429344|NCT00926796|P2|Participant Flow|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429345|NCT00926796|P1|Participant Flow|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429346|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429347|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429348|NCT00926796|O1|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429349|NCT00926796|O1|Outcome|Baseline|All per protocol participants at baseline with evaluable isolates
429350|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429351|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429352|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429353|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429354|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429355|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429356|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429357|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429358|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429359|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429360|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429361|NCT00926796|E2|Reported Event|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
429362|NCT00926796|E1|Reported Event|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
429363|NCT00926783|B3|Baseline|Total|Total of all reporting groups
429364|NCT00926783|B2|Baseline|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429365|NCT00926783|B1|Baseline|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429366|NCT00926783|P2|Participant Flow|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429367|NCT00926783|P1|Participant Flow|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429429|NCT00926393|P2|Participant Flow|Quetiapine XR|Quetiapine fumarate Extended Release
429430|NCT00926393|P1|Participant Flow|Quetiapine IR|Quetiapine fumarate Immediate Release
429431|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429368|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429369|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429370|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429371|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429372|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429373|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429374|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429375|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429376|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429377|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429378|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429379|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429380|NCT00926783|E2|Reported Event|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
429381|NCT00926783|E1|Reported Event|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
429382|NCT00926588|B3|Baseline|Total|Total of all reporting groups
429383|NCT00926588|B2|Baseline|Usual Care|Patients receive usual care for pain from their primary care physician
429432|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429433|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429434|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429435|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429384|NCT00926588|B1|Baseline|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
429385|NCT00926588|P2|Participant Flow|Usual Care|Patients receive usual care for pain from their primary care physician
429386|NCT00926588|P1|Participant Flow|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
429387|NCT00926588|O2|Outcome|Usual Care|Patients receive usual care for pain from their primary care physician
429388|NCT00926588|O1|Outcome|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
429389|NCT00926588|E2|Reported Event|Usual Care|Patients receive usual care for pain from their primary care physician
429390|NCT00926588|E1|Reported Event|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
429391|NCT00926575|B3|Baseline|Total|Total of all reporting groups
429392|NCT00926575|B2|Baseline|Placebo|
429393|NCT00926575|B1|Baseline|Active|oral beclomethasone 17,21-dipropionate (BDP)
429394|NCT00926575|P2|Participant Flow|Placebo|
429395|NCT00926575|P1|Participant Flow|Active|oral beclomethasone 17,21-dipropionate (BDP)
429396|NCT00926575|O2|Outcome|Placebo|
429397|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
429398|NCT00926575|O2|Outcome|Placebo|
429399|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
429400|NCT00926575|O2|Outcome|Placebo|
429401|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
429402|NCT00926575|E2|Reported Event|Placebo|
429403|NCT00926575|E1|Reported Event|Active|oral beclomethasone 17,21-dipropionate (BDP)
429404|NCT00926536|B3|Baseline|Total|Total of all reporting groups
429405|NCT00926536|B2|Baseline|DSA Only|DSA images only used for vessel navigation and tracking
429406|NCT00926536|B1|Baseline|C-arm CT + DSA as Needed|C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking
429407|NCT00926536|P2|Participant Flow|DSA Only|Only Digital subtraction images used for vessel tracking and tumor navigation
429408|NCT00926536|P1|Participant Flow|C-arm CT +DSA as Needed|C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation
429409|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
429410|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
429411|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
429412|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
429413|NCT00926536|E2|Reported Event|DSA Only|DSA only used for navigation
429414|NCT00926536|E1|Reported Event|C-arm CT + DSA as Needed|C-arm CT used for the purposes of navigation, supplemented by DSA if needed
429415|NCT00926497|B3|Baseline|Total|Total of all reporting groups
429416|NCT00926497|B2|Baseline|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
429417|NCT00926497|B1|Baseline|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
429418|NCT00926497|P2|Participant Flow|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
429419|NCT00926497|P1|Participant Flow|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
429420|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
429421|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
429422|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
429423|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
429424|NCT00926497|E2|Reported Event|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
429425|NCT00926497|E1|Reported Event|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
429426|NCT00926393|B3|Baseline|Total|Total of all reporting groups
429436|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429437|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429438|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429439|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429440|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429441|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429442|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429443|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429444|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429445|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429446|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429447|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429448|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429449|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429450|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429451|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429452|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429453|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429454|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429455|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
429456|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
429457|NCT00926393|E2|Reported Event|Quetiapine XR|Quetiapine fumarate Extended Release
429458|NCT00926393|E1|Reported Event|Quetiapine IR|Quetiapine fumarate Immediate Release
429459|NCT00926380|B4|Baseline|Total|Total of all reporting groups
429460|NCT00926380|B3|Baseline|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
429461|NCT00926380|B2|Baseline|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
429462|NCT00926380|B1|Baseline|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
429463|NCT00926380|P3|Participant Flow|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
429464|NCT00926380|P2|Participant Flow|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
429465|NCT00926380|P1|Participant Flow|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
429466|NCT00926380|O3|Outcome|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
429467|NCT00926380|O2|Outcome|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
429468|NCT00926380|O1|Outcome|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
429469|NCT00926380|E3|Reported Event|Denosumab and Teriparatide (Forteo®)|"denosumab: denosumab: 60 mg SC every 6 months~teriparatide: teriparatide: 20 mcg SC QD"
429470|NCT00926380|E2|Reported Event|Teriparatide (Forteo®) ONLY|teriparatide: teriparatide: 20 mcg SC QD
429471|NCT00926380|E1|Reported Event|Denosumab ONLY|denosumab: denosumab: 60 mg SC every 6 months
429472|NCT00926367|B3|Baseline|Total|Total of all reporting groups
429473|NCT00926367|B2|Baseline|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429474|NCT00926367|B1|Baseline|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429475|NCT00926367|P2|Participant Flow|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429476|NCT00926367|P1|Participant Flow|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429477|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429478|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429479|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429480|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429481|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429482|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429483|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429484|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429485|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429486|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429487|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429488|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429489|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429490|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429491|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429492|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429493|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429494|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429495|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429496|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429497|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429498|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429499|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429500|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429501|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429502|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429503|NCT00926367|O2|Outcome|Epiduo|Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429504|NCT00926367|O1|Outcome|Duac|Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429505|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429506|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429507|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429508|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429509|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429510|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429511|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429512|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429513|NCT00926367|E2|Reported Event|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
429514|NCT00926367|E1|Reported Event|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
429515|NCT00926328|B3|Baseline|Total|Total of all reporting groups
429516|NCT00926328|B2|Baseline|Placebo Control|sodium fluoride toothpaste
429517|NCT00926328|B1|Baseline|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
429518|NCT00926328|P2|Participant Flow|Placebo Control|sodium fluoride toothpaste
429519|NCT00926328|P1|Participant Flow|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
429520|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
429521|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
429522|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
429523|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
429524|NCT00926328|E2|Reported Event|Placebo Control|sodium fluoride toothpaste
429525|NCT00926328|E1|Reported Event|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
429526|NCT00926289|B3|Baseline|Total|Total of all reporting groups
429527|NCT00926289|B2|Baseline|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429528|NCT00926289|B1|Baseline|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429529|NCT00926289|P2|Participant Flow|Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429530|NCT00926289|P1|Participant Flow|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429531|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429532|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429533|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429534|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429535|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429536|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429537|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429538|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429539|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429540|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429541|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429542|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429543|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429544|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429545|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429546|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429547|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429548|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429549|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429550|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429551|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429552|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429553|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429554|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429555|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429556|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429557|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429558|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429559|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429560|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429561|NCT00926289|E2|Reported Event|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
429562|NCT00926289|E1|Reported Event|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
429563|NCT00926263|B3|Baseline|Total|Total of all reporting groups
429564|NCT00926263|B2|Baseline|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429565|NCT00926263|B1|Baseline|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429566|NCT00926263|P2|Participant Flow|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429567|NCT00926263|P1|Participant Flow|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429568|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429569|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429570|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429571|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429572|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429573|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429574|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429575|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429576|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429577|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429578|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429579|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429580|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429581|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429582|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429583|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429584|NCT00926263|O1|Outcome|CP-751,871 20/20 mg/kg|Participants not enrolled due to early termination of the study.
429585|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429586|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429587|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429588|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429589|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429590|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429591|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429592|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429593|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429594|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429595|NCT00926263|E2|Reported Event|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429596|NCT00926263|E1|Reported Event|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
429597|NCT00926211|B1|Baseline|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
429598|NCT00926211|P1|Participant Flow|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
429599|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
429600|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
429601|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
429602|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
429603|NCT00926211|E1|Reported Event|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
429604|NCT00926185|B5|Baseline|Total|Total of all reporting groups
429605|NCT00926185|B4|Baseline|Placebo|
429606|NCT00926185|B3|Baseline|Lifitegrast 5.0%|
429607|NCT00926185|B2|Baseline|Lifitegrast 1.0%|
429608|NCT00926185|B1|Baseline|Lifitegrast 0.1%|
429609|NCT00926185|P4|Participant Flow|Placebo|
429610|NCT00926185|P3|Participant Flow|Lifitegrast 5.0%|
429611|NCT00926185|P2|Participant Flow|Lifitegrast 1.0%|
429612|NCT00926185|P1|Participant Flow|Lifitegrast 0.1%|
429613|NCT00926185|O4|Outcome|Placebo|
429614|NCT00926185|O3|Outcome|Lifitegrast 5.0%|
429615|NCT00926185|O2|Outcome|Lifitegrast 1.0%|
429616|NCT00926185|O1|Outcome|Lifitegrast 0.1%|
429617|NCT00926185|O4|Outcome|Placebo|
429618|NCT00926185|O3|Outcome|Lifitegrast 5.0%|
429619|NCT00926185|O2|Outcome|Lifitegrast 1.0%|
429620|NCT00926185|O1|Outcome|Lifitegrast 0.1%|
429621|NCT00926185|E4|Reported Event|Placebo|
429622|NCT00926185|E3|Reported Event|Lifitegrast 5.0%|
429623|NCT00926185|E2|Reported Event|Lifitegrast 1.0%|
429624|NCT00926185|E1|Reported Event|Lifitegrast 0.1%|
429625|NCT00926029|B4|Baseline|Total|Total of all reporting groups
429626|NCT00926029|B3|Baseline|Experimental|triclosan/fluoride/zinc toothpaste
429627|NCT00926029|B2|Baseline|Positive Control|triclosan/fluoride toothpaste
429628|NCT00926029|B1|Baseline|Placebo Control|fluoride toothpaste
429629|NCT00926029|P3|Participant Flow|Experimental|triclosan/fluoride/metal salt toothpaste
429630|NCT00926029|P2|Participant Flow|Positive Control|triclosan/fluoride toothpaste
429631|NCT00926029|P1|Participant Flow|Placebo Control|fluoride toothpaste (Winterfresh Gel)
429632|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/zinc toothpaste
429633|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
429634|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste
429635|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/metal salt toothpaste
429636|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
429637|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste (Winterfresh Gel)
429638|NCT00926029|E3|Reported Event|Experimental|triclosan/fluoride/metal salt toothpaste
429639|NCT00926029|E2|Reported Event|Positive Control|triclosan/fluoride toothpaste
429640|NCT00926029|E1|Reported Event|Placebo Control|fluoride toothpaste (Winterfresh Gel)
429641|NCT00925990|B3|Baseline|Total|Total of all reporting groups
429642|NCT00925990|B2|Baseline|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
429643|NCT00925990|B1|Baseline|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
429691|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
430643|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
429644|NCT00925990|P2|Participant Flow|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
429645|NCT00925990|P1|Participant Flow|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
429646|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
429647|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
429648|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
429649|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
429650|NCT00925990|E2|Reported Event|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
429651|NCT00925990|E1|Reported Event|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
429652|NCT00925938|B4|Baseline|Total|Total of all reporting groups
429653|NCT00925938|B3|Baseline|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429654|NCT00925938|B2|Baseline|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
429655|NCT00925938|B1|Baseline|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429656|NCT00925938|P3|Participant Flow|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429657|NCT00925938|P2|Participant Flow|MVPI 800 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB)."
429658|NCT00925938|P1|Participant Flow|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429659|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429660|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
429661|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429662|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429663|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
429664|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429665|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429792|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of AUC 0-48 Sevelamer carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
429666|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
429667|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429668|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429669|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
429670|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429671|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429672|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
429673|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429674|NCT00925938|E3|Reported Event|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
429675|NCT00925938|E2|Reported Event|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
429676|NCT00925938|E1|Reported Event|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
429677|NCT00925899|B3|Baseline|Total|Total of all reporting groups
429678|NCT00925899|B2|Baseline|Placebo. Then Melatonin|Placebo then melatonin: Placebo tablet orally every evening about one hour before bedtime for one week. Then one week melatonin 20 mg orally.
429679|NCT00925899|B1|Baseline|Melatonin, Then Placebo|Melatonin then placebo: 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then 1 week placebo.
429680|NCT00925899|P2|Participant Flow|Part 1: Placebo, Then Melatonin|"First one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week.~Then one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week."
429681|NCT00925899|P1|Participant Flow|Part 1: Melatonin, Then Placebo|"First one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week.~Then one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week."
429682|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
429683|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
429684|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
429685|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
429686|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
429687|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
429688|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
429689|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between
429690|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
429854|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429692|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
429693|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
429694|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
429695|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
429696|NCT00925899|E2|Reported Event|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg. for one week.
429697|NCT00925899|E1|Reported Event|Melatonin Then Placebo|Melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then placebo for one week.
429698|NCT00925782|B1|Baseline|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
429699|NCT00925782|P2|Participant Flow|Alkeran - Melphalan|"Randomized group of Alkeran-Melphalan~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
429700|NCT00925782|P1|Participant Flow|Melphalan - Alkeran|"Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
429701|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
429702|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
429703|NCT00925782|O1|Outcome|Open-label, Randomized, Crossover Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation.
429704|NCT00925782|O1|Outcome|Open-label, Randomized, Cross-over Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
429705|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
429706|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
429707|NCT00925782|E1|Reported Event|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
429708|NCT00925769|B1|Baseline|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (Dose levels [DL]-1, 2, 3, 4, 5 and 6) were administered either oral 100 mg or 150 mg of erlotinib tablet daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429709|NCT00925769|P6|Participant Flow|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429710|NCT00925769|P5|Participant Flow|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429793|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of AUC 0-48 Lanthanum carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
429794|NCT00925704|E3|Reported Event|Calcitriol Alone|Calcitriol (1.0 microgram) single dose at lunch
429855|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429711|NCT00925769|P4|Participant Flow|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429712|NCT00925769|P3|Participant Flow|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429713|NCT00925769|P2|Participant Flow|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429714|NCT00925769|P1|Participant Flow|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 milligrams (mg) of erlotinib (ERL) tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 milligrams per kilogram (mg/kg) of bevacizumab (BEV) intravenous (IV) infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 milligrams per square meter (mg/m^2) of capecitabine (CAP) tablet twice daily (BID) within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429715|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429716|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429717|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429718|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429719|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429720|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429721|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429722|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429723|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429724|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429725|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429726|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429727|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429728|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429729|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429730|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429731|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429732|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429733|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429734|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429735|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429736|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429737|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429738|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429739|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429740|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429741|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429856|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429742|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429743|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429744|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429745|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429746|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429747|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429748|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429749|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429750|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429751|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429752|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429753|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429754|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429755|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429756|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429757|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429857|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429758|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429759|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429760|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429761|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429762|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429763|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429764|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429765|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429766|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429767|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429768|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429769|NCT00925769|E6|Reported Event|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429770|NCT00925769|E5|Reported Event|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429771|NCT00925769|E4|Reported Event|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429795|NCT00925704|E2|Reported Event|Sevelamer Carbonate + Calcitriol|Sevelamer carbonate (2400 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
429772|NCT00925769|E3|Reported Event|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429773|NCT00925769|E2|Reported Event|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429774|NCT00925769|E1|Reported Event|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
429775|NCT00925704|B7|Baseline|Total|Total of all reporting groups
429776|NCT00925704|B6|Baseline|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
429777|NCT00925704|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
429778|NCT00925704|B4|Baseline|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
429779|NCT00925704|B3|Baseline|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
429780|NCT00925704|B2|Baseline|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
429781|NCT00925704|B1|Baseline|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
429782|NCT00925704|P6|Participant Flow|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
429783|NCT00925704|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
429784|NCT00925704|P4|Participant Flow|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
429785|NCT00925704|P3|Participant Flow|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
429786|NCT00925704|P2|Participant Flow|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
429787|NCT00925704|P1|Participant Flow|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
429788|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the median of Tmax Sevelamer carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
429789|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the median of Tmax Lanthanum carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
429790|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of Cmax Sevelamer carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
429791|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of Cmax Lanthanum carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
429853|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429796|NCT00925704|E1|Reported Event|Lanthanum Carbonate + Calcitriol|Lanthanum carbonate (1000 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
429797|NCT00925600|B3|Baseline|Total|Total of all reporting groups
429798|NCT00925600|B2|Baseline|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429799|NCT00925600|B1|Baseline|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
429800|NCT00925600|P2|Participant Flow|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429801|NCT00925600|P1|Participant Flow|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
429802|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429803|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
429804|NCT00925600|O4|Outcome|Denosumab - Right Eye|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429805|NCT00925600|O3|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429806|NCT00925600|O2|Outcome|Placebo - Right Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
429807|NCT00925600|O1|Outcome|Placebo - Left Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
429808|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429809|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
429810|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429811|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
429812|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429813|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
429814|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429815|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
429816|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429817|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
429818|NCT00925600|E2|Reported Event|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
429819|NCT00925600|E1|Reported Event|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
429820|NCT00925587|B3|Baseline|Total|Total of all reporting groups
429821|NCT00925587|B2|Baseline|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429822|NCT00925587|B1|Baseline|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429823|NCT00925587|P2|Participant Flow|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429824|NCT00925587|P1|Participant Flow|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429825|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429826|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429827|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429828|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429829|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429830|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429831|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429832|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429833|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429834|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429835|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429836|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429837|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429838|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429839|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429840|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429841|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429842|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429843|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429844|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429845|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429846|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429847|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429848|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429849|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429850|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429851|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429852|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429858|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429859|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429860|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429861|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429862|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429863|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429864|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429865|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429866|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429867|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429868|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429869|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429870|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429871|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429872|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429873|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429874|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429875|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429876|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429877|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429878|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429879|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429880|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429881|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429882|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429883|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429884|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429885|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429886|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429887|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429888|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429889|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429890|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429891|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429892|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429893|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429894|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429895|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429896|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429897|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429898|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429899|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429900|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429901|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429902|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429903|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429904|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429905|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429906|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429907|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429908|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429909|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429910|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429911|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429912|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429913|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429914|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429915|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429916|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429917|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429918|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429919|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429920|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429921|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429922|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
430644|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
429923|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429924|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429925|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429926|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429927|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429928|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429929|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429930|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429931|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429932|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429933|NCT00925587|E2|Reported Event|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
429934|NCT00925587|E1|Reported Event|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
429935|NCT00925548|B3|Baseline|Total|Total of all reporting groups
429936|NCT00925548|B2|Baseline|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429937|NCT00925548|B1|Baseline|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429938|NCT00925548|P2|Participant Flow|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429939|NCT00925548|P1|Participant Flow|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429940|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429941|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429942|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429943|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
430017|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
429944|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429945|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429946|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429947|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429948|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429949|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429950|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429951|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429952|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429953|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
430018|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430392|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
429954|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429955|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429956|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429957|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429958|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429959|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429960|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429961|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
429962|NCT00925548|E2|Reported Event|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
429963|NCT00925548|E1|Reported Event|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
430019|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
429964|NCT00925522|B1|Baseline|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids."
429965|NCT00925522|P1|Participant Flow|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of following three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the cat"
429966|NCT00925522|O1|Outcome|Therapy Cool Path Duo Catheter|All patients received RF (radio frequency) therapy from ablation catheter.
429967|NCT00925522|E1|Reported Event|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the catheter in the hospital environment."
429968|NCT00925353|B1|Baseline|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
429969|NCT00925353|P1|Participant Flow|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
429970|NCT00925353|O1|Outcome|Lidocaine Gel Group|Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography.
429971|NCT00925353|E1|Reported Event|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
429972|NCT00925288|B3|Baseline|Total|Total of all reporting groups
429973|NCT00925288|B2|Baseline|Modified Schedule|Duration: 0,3,6 months
429974|NCT00925288|B1|Baseline|Regular Schedule|Duration: 0,2,6 months
429975|NCT00925288|P2|Participant Flow|Modified Schedule|Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
429976|NCT00925288|P1|Participant Flow|Regular Schedule|Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
429977|NCT00925288|O2|Outcome|Modified Schedule|Participants in 0,3,6 month study arm
429978|NCT00925288|O1|Outcome|Regular Schedule|Participants in 0,2,6 month study arm
429979|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
429980|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
429981|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
429982|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
429983|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
429984|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
429985|NCT00925288|E2|Reported Event|Modified Schedule|Duration: 0,3,6 months
429986|NCT00925288|E1|Reported Event|Regular Schedule|Duration: 0,2,6 months
429987|NCT00925132|B1|Baseline|Temozolomide, Decitabine, Panobinostat|"Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation.~Temozolomide, Decitabine, Panobinostat: Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation."
429988|NCT00925132|P5|Participant Flow|Phase II:Decitabine 0.2 mg/kg+Panobinostat 30mg+Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
429989|NCT00925132|P4|Participant Flow|Phase I:Decitabine 0.2 mg/kg + Panobinostat 30mg +Temozolomide|Cohort 4: Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
429990|NCT00925132|P3|Participant Flow|Phase I:Decitabine 0.2 mg/kg + Panobinostat 20mg+Temozolomide|Cohort 3: Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 20mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
430020|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430393|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
429991|NCT00925132|P2|Participant Flow|Phase I:Decitabine 0.1 mg/kg + Panobinostat 20mg +Temozolomide|Cohort 2: Participants were administered Decitabine 0.1 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 20mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
429992|NCT00925132|P1|Participant Flow|Phase I:Decitabine 0.1mg/kg + Panobinostat 10mg + Temozolomide|Cohort 1: Participants were administered Decitabine 0.1 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 10mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
429993|NCT00925132|O1|Outcome|Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg+Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly and Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
429994|NCT00925132|O1|Outcome|Phase II:Decitabine 0.2 mg/kg +Panobinostat 30mg +Temozolomide|Participants were administered Decitabine 0.2 mg/kg via subcutaneous injection (SQ) 3x weekly, Panobinostat 30mg orally (PO) once every 96 hours for 2 weeks and Temozolomide at a dose of 150 mg/m2 orally Day 9 through 13 for 5 doses. Dose for Temozolomide was escalated to 200 mg/m2 for 5 days after Cycle 1.
429995|NCT00925132|O1|Outcome|Phase I Dose Escalation|"Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation."
429996|NCT00925132|E1|Reported Event|Temozolomide, Decitabine, Panobinostat|"Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation.~Temozolomide, Decitabine, Panobinostat: Temozolomide - given each cycle.~Decitabine - 6 cohorts with dose escalation.~Panobinostat - 6 cohorts with dose escalation."
429997|NCT00925119|B1|Baseline|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
429998|NCT00925119|P1|Participant Flow|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
429999|NCT00925119|O1|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430000|NCT00925119|O1|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430001|NCT00925119|O1|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430002|NCT00925119|O1|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430003|NCT00925119|O1|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430004|NCT00925119|O1|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430005|NCT00925119|O1|Outcome|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430006|NCT00925119|E1|Reported Event|Atenolol|"Participants will receive atenolol for 8 weeks.~Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated"
430007|NCT00925015|B4|Baseline|Total|Total of all reporting groups
430008|NCT00925015|B3|Baseline|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long. For Drug-Drug Interaction (DDI).
430009|NCT00925015|B2|Baseline|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
430010|NCT00925015|B1|Baseline|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
430011|NCT00925015|P3|Participant Flow|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long. For Drug-Drug Interaction (DDI).
430012|NCT00925015|P2|Participant Flow|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
430013|NCT00925015|P1|Participant Flow|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
430014|NCT00925015|O3|Outcome|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For DDI.
430015|NCT00925015|O2|Outcome|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
430016|NCT00925015|O1|Outcome|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1,8, 15, 22, 29 and 36.
430645|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430021|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430022|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430023|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430024|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430025|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430026|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430027|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430028|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430029|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430030|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430031|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430032|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430033|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430034|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430035|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430036|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430037|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430038|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430039|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430040|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430041|NCT00925015|O2|Outcome|Cetuximab/Irinotecan + Dalotuzumab 10 mg/kg|Participants previously treated with Cetuximab/Irinotecan were treated in Cycle 1, Day 29 with Dalotuzumab 10 mg/kg
430042|NCT00925015|O1|Outcome|Cetuximab/Irinotecan Alone|Participants were treated in Cycle 1, Day 15 with Cetuximab/Irinotecan alone
430043|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430044|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430045|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430046|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430047|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430048|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430049|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430050|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430051|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430052|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430053|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430054|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430055|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430056|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430057|NCT00925015|O2|Outcome|Dalotuzumab 10 mg/kg + Cetuximab/Irinotecan|Participants were treated in Cycle 1, Day 22 with both Dalotuzumab + Cetuximab/Irinotecan
430058|NCT00925015|O1|Outcome|Dalotuzumab 10 mg/kg Alone|Participants were treated in Cycle 1, Day 1 with Dalotuzumab alone
430059|NCT00925015|O3|Outcome|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For DDI.
430060|NCT00925015|O2|Outcome|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
430061|NCT00925015|O1|Outcome|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1,8, 15, 22, 29 and 36.
430174|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430062|NCT00925015|O3|Outcome|Dmab 10 mg/kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For DDI.
430063|NCT00925015|O2|Outcome|Cetux/Irin - Dmab 15/7.5 mg/kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Day 8; followed in subsequent infusions by treatment with 7.5 mg/kg on Days 22 and 36. Each cycle was 6 weeks long.
430064|NCT00925015|O1|Outcome|Cetux/Irin - Dmab 10 mg/kg|After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1,8, 15, 22, 29 and 36.
430065|NCT00925015|E3|Reported Event|Dalotuzumab 10 mg/Kg - Cetux/Irin (DDI)|Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. Each cycle was 6 weeks long.
430066|NCT00925015|E2|Reported Event|Cetux/Irin - Dalotuzumab 15/7.5 mg/Kg|After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Days 8, 22 and 36; followed in subsequent cycles by treatment with 7.5 mg/kg on Days 8, 22 and 36. Each cycle was 6 weeks long.
430067|NCT00925015|E1|Reported Event|Cetux/Irin - Dalotuzumab 10 mg/Kg|After treatment with Cetux and Irin, Dmab was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long.
430068|NCT00924950|B1|Baseline|Ointment + Patch vs. Ointment Alone|
430069|NCT00924950|P1|Participant Flow|Ointment + Patch vs. Ointment Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used topically to treat one psoriatic plaque with Hydrogel patch used over for occlusion for 6-8 hours daily. Within the same patient another patch of similar severity was chosen and was treated with Taclonex ointment alone without hydrogel patch occlusion
430070|NCT00924950|O2|Outcome|Taclonex Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch.
430071|NCT00924950|O1|Outcome|Taclonex Ointment Occluded With Hydrogel Patch|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily topically to treat one psoriatic plaque, occluded with hydrogel patch for 6-8 hours each day.
430072|NCT00924950|E1|Reported Event|Ointment + Patch vs. Ointment Alone|
430073|NCT00924898|B1|Baseline|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
430074|NCT00924898|P1|Participant Flow|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
430075|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants who remained on treatment at designated time points.
430076|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Baseline resistance testing was performed on all participants at enrollment.
430077|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Acute HIV infection treatment group
430078|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants who remained on study with viral suppression at week 96
430079|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <50 copies/mL prior at week 48
430080|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <200 copies/mL prior to or at week 24
430081|NCT00924898|E1|Reported Event|Acute HIV Infection Treatment Group|Single-arml study of once daily emtricitabine/tenofovir/efavirenz administered to participants with acute HIV infection
430082|NCT00924833|B4|Baseline|Total|Total of all reporting groups
430083|NCT00924833|B3|Baseline|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
430084|NCT00924833|B2|Baseline|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
430085|NCT00924833|B1|Baseline|Placebo|Placebo tablets. One tablet twice daily.
430086|NCT00924833|P3|Participant Flow|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
430087|NCT00924833|P2|Participant Flow|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
430088|NCT00924833|P1|Participant Flow|Placebo|Placebo tablets. One tablet twice daily.
430089|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
430090|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
430091|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
430092|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
430093|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
430094|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
430095|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
430096|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
430097|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
430098|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
430099|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
430100|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
430101|NCT00924807|B1|Baseline|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
430102|NCT00924807|P1|Participant Flow|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
430103|NCT00924807|O1|Outcome|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
430394|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430104|NCT00924807|E1|Reported Event|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
430105|NCT00924781|B5|Baseline|Total|Total of all reporting groups
430106|NCT00924781|B4|Baseline|MK2578 1mcg/350U QM|MK2578 IV administered QM.
430107|NCT00924781|B3|Baseline|MK2578 1mcg/350U QW|MK2578 IV administered QW.
430108|NCT00924781|B2|Baseline|MK2578 1mcg/600U QM|MK2578 IV administered QM.
430109|NCT00924781|B1|Baseline|MK2578 1mcg/600U QW|MK2578 IV administered QW.
430110|NCT00924781|P2|Participant Flow|MK2578 1mcg/600 U or 1 mg/350 U QM|MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline.
430111|NCT00924781|P1|Participant Flow|MK2578 1mcg/600 U or 1 mcg/350 U QW|MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
430112|NCT00924781|O4|Outcome|MK-2578 1mcg/350U QM|MK2578 IV was administered QM. Participatns were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alpha) received per 4 weeks at Baseline.
430113|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
430114|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
430115|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK3578 IV was administered QW. Participants were randomized to receive 1 mcg of MK-2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430116|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430117|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430118|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430119|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430120|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430121|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every U of Epogen (epoetin alpha) received per week at Baseline.
430122|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430123|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430124|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM.Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430125|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430126|NCT00924781|O2|Outcome|MK2578 1mcg/600 QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430127|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430128|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430129|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430130|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430131|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430132|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430133|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430134|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430135|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430136|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430137|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
430138|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
430395|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430139|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
430140|NCT00924781|E2|Reported Event|MK2578 QM|MK2578 IV administered once every 4 weeks.
430141|NCT00924781|E1|Reported Event|MK2578 QW|MK2578 IV administered once weekly.
430142|NCT00924729|B3|Baseline|Total|Total of all reporting groups
430143|NCT00924729|B2|Baseline|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430144|NCT00924729|B1|Baseline|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430145|NCT00924729|P2|Participant Flow|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430146|NCT00924729|P1|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430147|NCT00924729|O2|Outcome|Besifloxacin 0.6% Ophthalmic Suspension|Besifloxacin 0.6% ophthalmic suspension: Administer besifloxacin study drug prior to cataract surgery.
430148|NCT00924729|O1|Outcome|Moxifloxacin 0.5% Ophthalmic Solution|Moxifloxacin 0.5% ophthalmic solution: Administer moxifloxacin study drug prior to cataract surgery.
430149|NCT00924729|O2|Outcome|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430150|NCT00924729|O1|Outcome|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430151|NCT00924729|E2|Reported Event|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430152|NCT00924729|E1|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
430153|NCT00924651|B3|Baseline|Total|Total of all reporting groups
430154|NCT00924651|B2|Baseline|Standard Care|Wait list control
430155|NCT00924651|B1|Baseline|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
430156|NCT00924651|P2|Participant Flow|Standard Care|Wait list control
430157|NCT00924651|P1|Participant Flow|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
430158|NCT00924651|O2|Outcome|Standard Care|Wait list control
430159|NCT00924651|O1|Outcome|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
430160|NCT00924651|E2|Reported Event|Standard Care|Wait list control
430161|NCT00924651|E1|Reported Event|Standard Care + EXCAP|"Personalized exercise prescription~exercise: home based walking and progressive resistance training exercise"
430162|NCT00924638|B3|Baseline|Total|Total of all reporting groups
430163|NCT00924638|B2|Baseline|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430164|NCT00924638|B1|Baseline|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430165|NCT00924638|P2|Participant Flow|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430166|NCT00924638|P1|Participant Flow|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430167|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430168|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430169|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430170|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430171|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430172|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430173|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430646|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430175|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430176|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430177|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430178|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430179|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430180|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430181|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430182|NCT00924638|E2|Reported Event|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
430183|NCT00924638|E1|Reported Event|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
430184|NCT00924560|B4|Baseline|Total|Total of all reporting groups
430185|NCT00924560|B3|Baseline|Untreated Control|Participants received no oral contraceptives during the study.
430186|NCT00924560|B2|Baseline|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430187|NCT00924560|B1|Baseline|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430188|NCT00924560|P3|Participant Flow|Untreated Control|Participants received no oral contraceptives during the study.
430189|NCT00924560|P2|Participant Flow|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430190|NCT00924560|P1|Participant Flow|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430191|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430192|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430193|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430194|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430195|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430196|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430197|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430198|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430199|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430200|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430201|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430202|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430203|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430204|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430647|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430205|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430206|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430207|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430208|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430209|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430210|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430211|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430212|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430213|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430214|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430215|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430216|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430217|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430218|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430219|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430220|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430221|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430222|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430223|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430224|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430225|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430226|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430227|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
430228|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430229|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430230|NCT00924560|E3|Reported Event|Untreated Control|Participants received no oral contraceptives during the study.
430231|NCT00924560|E2|Reported Event|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
430232|NCT00924560|E1|Reported Event|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
430233|NCT00924508|B1|Baseline|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
430234|NCT00924508|P1|Participant Flow|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
430235|NCT00924508|O1|Outcome|Hydrogel Patch Alone, TAC 0.1%, TAC + Patch|"This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, the second treated with 0.1 % triamcinolone ointment without patch, and the third treated with occlusion of eczema patch without ointment.~occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone"
430236|NCT00924508|O3|Outcome|Patch + TAC|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
430237|NCT00924508|O2|Outcome|TAC 0.1%|Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
430238|NCT00924508|O1|Outcome|Hydrogel Patch|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
430239|NCT00924508|E1|Reported Event|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
430240|NCT00924482|B1|Baseline|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
430241|NCT00924482|P1|Participant Flow|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
430242|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
430243|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
430244|NCT00924482|E1|Reported Event|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
430245|NCT00924469|B3|Baseline|Total|Total of all reporting groups
430246|NCT00924469|B2|Baseline|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430247|NCT00924469|B1|Baseline|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430333|NCT00924170|O1|Outcome|Fludarabine and Cyclophosphamide: 20 + 200mg/m^2|Patients CF15, CF16, and CF17. Patient CF15 did not receive LMB-2, others received 40 µg/kg
430248|NCT00924469|P2|Participant Flow|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430249|NCT00924469|P1|Participant Flow|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430250|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430251|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430252|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430253|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430254|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430255|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430256|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430257|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430258|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430259|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430260|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430261|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430262|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430263|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430264|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430327|NCT00924170|B2|Baseline|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430265|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430266|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430267|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430268|NCT00924469|E2|Reported Event|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
430269|NCT00924469|E1|Reported Event|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
430270|NCT00924443|B1|Baseline|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
430271|NCT00924443|P1|Participant Flow|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days
430272|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
430273|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
430274|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
430275|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
430276|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
430277|NCT00924443|E1|Reported Event|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
430278|NCT00924404|B3|Baseline|Total|Total of all reporting groups
430279|NCT00924404|B2|Baseline|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
430280|NCT00924404|B1|Baseline|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
430281|NCT00924404|P2|Participant Flow|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
430282|NCT00924404|P1|Participant Flow|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
430283|NCT00924404|O2|Outcome|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
430284|NCT00924404|O1|Outcome|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
430285|NCT00924404|O2|Outcome|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
430286|NCT00924404|O1|Outcome|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
430287|NCT00924404|E2|Reported Event|Saline|"saline for sinus rinse~Saline: saline for sinus rinse"
430288|NCT00924404|E1|Reported Event|Xylitol|"isotonic xylitol for sinus rinse~Xylitol: 5% solution for sinus rinse"
430289|NCT00924352|B1|Baseline|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430290|NCT00924352|P2|Participant Flow|Phase II|The Phase II sample includes patients who were enrolled into the Phase II portion of this study. Dasatinib and ixabepilone were administered at the maximum tolerated dose determined during the Phase I portion: dasatinib 100 mg daily and ixabepilone 20 mg/m2. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
430328|NCT00924170|B1|Baseline|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430291|NCT00924352|P1|Participant Flow|Phase I|The Phase I sample includes patients who were enrolled into the Phase I portion of this study. Patients received treatment according to the assigned dose level. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
430292|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430293|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430294|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430295|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430296|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430297|NCT00924352|O3|Outcome|Ixabepilone + Dasatinib (Dose Level 2)|Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
430298|NCT00924352|O2|Outcome|Ixabepilone + Dasatinib (Dose Level 1)|Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
430299|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib (Dose Level 0)|Dasatinib 100 mg daily and Ixabepilone 16 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
430300|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430329|NCT00924170|P2|Participant Flow|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430330|NCT00924170|P1|Participant Flow|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430331|NCT00924170|O3|Outcome|3Fludarabine and Cyclophosphamide: 0 + 300mg/m^2|Patients CF08 and CF09, both received LMB-2 40 µg/kg
430334|NCT00924170|O3|Outcome|Fludarabine and Cyclophosphamide: 30 + 300mg/m^2|Patients CF08 and CF09, both received LMB-2 40 µg/kg
430301|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430302|NCT00924352|E1|Reported Event|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
430303|NCT00924313|B1|Baseline|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430304|NCT00924313|P1|Participant Flow|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430305|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430306|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430307|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430308|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430309|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430310|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430311|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430312|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430313|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430314|NCT00924313|E1|Reported Event|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
430315|NCT00924287|B1|Baseline|Metastatic Cancer|Cancer that has invaded other parts of the body
430316|NCT00924287|P1|Participant Flow|Metastatic Cancer|Cancer that has invaded other parts of the body
430317|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
430318|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
430319|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
430320|NCT00924287|E1|Reported Event|Metastatic Cancer|Cancer that has invaded other parts of the body
430321|NCT00924209|B1|Baseline|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
430322|NCT00924209|P1|Participant Flow|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
430323|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
430324|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
430325|NCT00924209|E1|Reported Event|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
430326|NCT00924170|B3|Baseline|Total|Total of all reporting groups
430332|NCT00924170|O2|Outcome|Fludarabine and Cyclophosphamide: 25 + 250mg/m^2|All other patients, including CF18 and CF01 who did not receive LMB2. Patients CF02 and CF03 and CF04 received LMB-2 30 µg/kg, others 40 µg/kg
430335|NCT00924170|O2|Outcome|Fludarabine and Cyclophosphamide: 25 + 250mg/m^2|All other patients, including CF18 and CF01 who did not receive LMB2. Patients CF02 and CF03 and CF04 received LMB-2 30 µg/kg, others 40 µg/kg.
430336|NCT00924170|O1|Outcome|Fludarabine and Cyclophosphamide: 20 + 200mg/m^2|Patients CF15, CF16, and CF17. Patient CF15 did not receive LMB-2, others received 40 µg/kg.
430337|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430338|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430339|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430340|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430341|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430342|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430343|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430344|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430345|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430346|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430347|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430348|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430349|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430350|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430351|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430352|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430353|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430354|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430355|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430356|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430357|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430358|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430359|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430360|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430361|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430362|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430363|NCT00924170|O2|Outcome|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430648|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430364|NCT00924170|O1|Outcome|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430365|NCT00924170|E2|Reported Event|All Other Patients|Patients CF01-CF02, CF06, CF11, and CF15-CF18. This is a mixture of patients who did not receive LMB-2, who had lymphoma-type adult T-cell leukemia, and who received 20+250 mg/m^2 of fludarabine cyclophosphamide (FC).
430366|NCT00924170|E1|Reported Event|Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC|Leukemic patients receiving LMB-2 and at least 25+250 mg/m^2 fludarabine and cyclophosphamide; CF03-CF05, CF07-CF10, and CF12-CF14.
430367|NCT00924118|B3|Baseline|Total|Total of all reporting groups
430368|NCT00924118|B2|Baseline|Open Control|Subjects randomized to open control will receive no experimental therapy.
430369|NCT00924118|B1|Baseline|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
430370|NCT00924118|P2|Participant Flow|Open Control|Subjects randomized to open control will receive no experimental therapy.
430371|NCT00924118|P1|Participant Flow|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
430372|NCT00924118|O2|Outcome|Open Control|Subjects randomized to open control will receive no experimental therapy.
430373|NCT00924118|O1|Outcome|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
430374|NCT00924118|O2|Outcome|Open Control|Subjects randomized to open control will receive no experimental therapy.
430375|NCT00924118|O1|Outcome|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
430376|NCT00924118|E2|Reported Event|Open Control|Subjects randomized to open control will receive no experimental therapy.
430377|NCT00924118|E1|Reported Event|Sodium Nitrite|"Dose escalation of sodium nitrite.~Sodium Nitrite: Subjects assigned to sodium nitrite will receive an initial infusion of 6 nmol/min/kg for 48 hours. After the first six subjects have been enrolled (3 active drug, 3 control) and if there are no dose limiting toxicities, additional cohorts of six subjects each will be randomized to escalating doses of sodium nitrite versus control for a total of 30 subjects."
430378|NCT00924066|B1|Baseline|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
430379|NCT00924066|P1|Participant Flow|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
430380|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
430381|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
430382|NCT00924066|E1|Reported Event|Adverse Events for Squamous and Non-squamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
430383|NCT00924053|B5|Baseline|Total|Total of all reporting groups
430384|NCT00924053|B4|Baseline|EGT0001474 150mg|Received six 25 mg capsules once daily.
430385|NCT00924053|B3|Baseline|EGT0001474 75 mg|Received three 25mg capsules once daily.
430386|NCT00924053|B2|Baseline|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430387|NCT00924053|B1|Baseline|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430388|NCT00924053|P4|Participant Flow|EGT0001474 150mg|Received six 25 mg capsules once daily.
430389|NCT00924053|P3|Participant Flow|EGT0001474 75 mg|Received three 25mg capsules once daily.
430390|NCT00924053|P2|Participant Flow|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430391|NCT00924053|P1|Participant Flow|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430649|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430396|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430397|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430398|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430399|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430400|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430401|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430402|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430403|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430404|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430405|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430406|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430407|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430408|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430409|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430410|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430411|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430412|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430413|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430414|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430415|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430416|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430417|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430418|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430419|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430420|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430421|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430422|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430423|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430424|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430425|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430426|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430427|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430428|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
430429|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
430430|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430431|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430432|NCT00924053|E4|Reported Event|EGT0001474 150mg|Received six 25 mg capsules once daily.
430433|NCT00924053|E3|Reported Event|EGT0001474 75 mg|Received three 25mg capsules once daily.
430434|NCT00924053|E2|Reported Event|EGT0001474 25 mg|Received one 25 mg capsule once daily.
430435|NCT00924053|E1|Reported Event|Placebo|Received 1, 3, or 6 placebo capsules once daily.
430436|NCT00924040|B1|Baseline|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430437|NCT00924040|P1|Participant Flow|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430438|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430439|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430440|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430441|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430442|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430443|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430444|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430445|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430446|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430447|NCT00924040|E1|Reported Event|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
430448|NCT00924001|B1|Baseline|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
430449|NCT00924001|P1|Participant Flow|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
430450|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
430451|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
430452|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
430453|NCT00924001|E1|Reported Event|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
430454|NCT00923975|B1|Baseline|Intended Users of the Software|Baseline measures were analyzed using only data for the young adults (18-24 years of age) and parents/guardians (18 to 47 years of age) of children with diabetes, not healthcare professionals. Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria.
430455|NCT00923975|P1|Participant Flow|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
430456|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
430457|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
430458|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
430459|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
430460|NCT00923975|E1|Reported Event|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
430461|NCT00923949|B1|Baseline|Pioglitazone|45 mg tablet daily by mouth for six weeks
430462|NCT00923949|P1|Participant Flow|Pioglitazone|45 mg tablet daily by mouth for six weeks
430463|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
430464|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
430465|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
430466|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
430467|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
430468|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
430469|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
430470|NCT00923949|E1|Reported Event|Pioglitazone|45 mg tablet daily by mouth for six weeks
430471|NCT00923936|B3|Baseline|Total|Total of all reporting groups
430472|NCT00923936|B2|Baseline|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430473|NCT00923936|B1|Baseline|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430474|NCT00923936|P2|Participant Flow|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430475|NCT00923936|P1|Participant Flow|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430476|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430491|NCT00923910|P2|Participant Flow|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
430492|NCT00923910|P1|Participant Flow|Donors|Period 1 -Donor lymphocyte collection via apheresis. Period 2 -Donor cell processing for vaccine and infusion.
430493|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
430477|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430478|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430479|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430480|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430481|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430482|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430483|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430484|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430485|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430486|NCT00923936|E2|Reported Event|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430487|NCT00923936|E1|Reported Event|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
430488|NCT00923910|B3|Baseline|Total|Total of all reporting groups
430489|NCT00923910|B2|Baseline|Recipients|Vaccine and donor lymphocyte prep
430490|NCT00923910|B1|Baseline|Donors|Donor lymphocyte collection via apheresis.
430611|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430494|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
430495|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
430496|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
430497|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
430498|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
430499|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
430500|NCT00923910|E1|Reported Event|Recipients|Vaccine and donor lymphocyte prep
430501|NCT00923845|B3|Baseline|Total|Total of all reporting groups
430502|NCT00923845|B2|Baseline|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430503|NCT00923845|B1|Baseline|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
430504|NCT00923845|P2|Participant Flow|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430505|NCT00923845|P1|Participant Flow|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
430506|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430507|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430508|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430509|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430510|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430511|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430512|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430513|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430514|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430515|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430516|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430517|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430518|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430519|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430520|NCT00923845|O2|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430521|NCT00923845|O1|Outcome|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
430522|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430523|NCT00923845|E2|Reported Event|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
430524|NCT00923845|E1|Reported Event|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
430525|NCT00923481|B1|Baseline|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
430526|NCT00923481|P1|Participant Flow|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
430527|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
430528|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
430529|NCT00923481|E1|Reported Event|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
430530|NCT00923364|B1|Baseline|Recipients and Healthy Related Donors|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2~Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)~Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14."
430531|NCT00923364|P2|Participant Flow|Healthy Related Donors|
430532|NCT00923364|P1|Participant Flow|Recipients|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2~Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)~Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
430612|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430613|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430533|NCT00923364|O1|Outcome|Recipients and Healthy Related Donors|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14."
430534|NCT00923364|O1|Outcome|Recipients Only|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
430535|NCT00923364|O1|Outcome|Recipients Only|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
430536|NCT00923364|O1|Outcome|Recipients Only|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
430537|NCT00923364|O1|Outcome|Recipients Only|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
430538|NCT00923364|O1|Outcome|Recipients Only|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
430539|NCT00923364|O1|Outcome|Recipients Only|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant"
430540|NCT00923364|E1|Reported Event|Recipients and Healthy Related Donors|"Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.~Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14."
430541|NCT00923351|B3|Baseline|Total|Total of all reporting groups
430542|NCT00923351|B2|Baseline|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
430543|NCT00923351|B1|Baseline|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
430544|NCT00923351|P3|Participant Flow|Enrolled But Not Assigned to Treatment|Twelve participants were not treated in Arm A or Arm B because they did not get far enough in the study to be designated for an Arm. Were unable to obtain apheresis, and adequate tumor samples.
430545|NCT00923351|P2|Participant Flow|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose subcutaneous (SQ) (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
430546|NCT00923351|P1|Participant Flow|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participant will receive Tumor lysate/keyhole limpet hemocyanin (KLH) pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
430547|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
430548|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
430549|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
430550|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
430551|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
430552|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
430553|NCT00923351|E2|Reported Event|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
430614|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430615|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430616|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430554|NCT00923351|E1|Reported Event|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
430555|NCT00923273|B6|Baseline|Total|Total of all reporting groups
430556|NCT00923273|B5|Baseline|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
430557|NCT00923273|B4|Baseline|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
430558|NCT00923273|B3|Baseline|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
430559|NCT00923273|B2|Baseline|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
430560|NCT00923273|B1|Baseline|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
430561|NCT00923273|P5|Participant Flow|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
430562|NCT00923273|P4|Participant Flow|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
430563|NCT00923273|P3|Participant Flow|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
430564|NCT00923273|P2|Participant Flow|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
430565|NCT00923273|P1|Participant Flow|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
430566|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
430567|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
430568|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
430569|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
430570|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
430571|NCT00923273|O1|Outcome|Treatment Level 4: 10mg Load|"Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2~Includes 8 subjects with prior peme; 12 subjects who were peme naive;and 7 subjects rolled over from ph I"
430572|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
430573|NCT00923273|O4|Outcome|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
430574|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
430575|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
430576|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
430577|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
430578|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
430579|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
430580|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
430581|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
430582|NCT00923273|E5|Reported Event|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
430583|NCT00923273|E4|Reported Event|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
430584|NCT00923273|E3|Reported Event|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
430585|NCT00923273|E2|Reported Event|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
430586|NCT00923273|E1|Reported Event|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
430587|NCT00923260|B3|Baseline|Total|Total of all reporting groups
430588|NCT00923260|B2|Baseline|Roux-en-Y Gastric Bypass Alone|
430589|NCT00923260|B1|Baseline|Roux-en-Y Gastric Bypass/Omentectomy|
430590|NCT00923260|P2|Participant Flow|Roux-en-Y Gastric Bypass Alone|
430591|NCT00923260|P1|Participant Flow|Roux-en-Y Gastric Bypass/Omentectomy|
430592|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430593|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430594|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430595|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430596|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430597|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430598|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430599|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430600|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430601|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430602|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430603|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430604|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430605|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430606|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430607|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430608|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430609|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430610|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430650|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430651|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430652|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430653|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430654|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430655|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430656|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430657|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430658|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430659|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430660|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430661|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430662|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430663|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430664|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430665|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430666|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430667|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430668|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430669|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430670|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430671|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430672|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430673|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430674|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430675|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430676|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430677|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430678|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430679|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430680|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430681|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430682|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430683|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430684|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430685|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430686|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430687|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430688|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430689|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430690|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430691|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430692|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430693|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430694|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430695|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430696|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430697|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430698|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430699|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430700|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430701|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430702|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430703|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430704|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430705|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430706|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430707|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430708|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430709|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430710|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430711|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430712|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430713|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430714|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430715|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430716|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430717|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430718|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
430719|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
430720|NCT00923260|E2|Reported Event|Roux-en-Y Gastric Bypass Alone|
430721|NCT00923260|E1|Reported Event|Roux-en-Y Gastric Bypass/Omentectomy|
430722|NCT00923247|B3|Baseline|Total|Total of all reporting groups
430723|NCT00923247|B2|Baseline|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430724|NCT00923247|B1|Baseline|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430762|NCT00923156|B4|Baseline|Total|Total of all reporting groups
430725|NCT00923247|P2|Participant Flow|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430726|NCT00923247|P1|Participant Flow|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430727|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430728|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430729|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430730|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430731|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430732|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430733|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430734|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430735|NCT00923247|O2|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430736|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430737|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430738|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430739|NCT00923247|O2|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430779|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430740|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430741|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430742|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430743|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430744|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430745|NCT00923247|O1|Outcome|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430746|NCT00923247|O1|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430747|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430748|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib to find the maximally tolerated dose.~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib on days 1, 4, 8 & 11 every 28 days in adults"
430749|NCT00923247|E2|Reported Event|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430750|NCT00923247|E1|Reported Event|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
430751|NCT00923195|B3|Baseline|Total|Total of all reporting groups
430752|NCT00923195|B2|Baseline|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430753|NCT00923195|B1|Baseline|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430763|NCT00923156|B3|Baseline|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
430894|NCT00923078|O2|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
430754|NCT00923195|P2|Participant Flow|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430755|NCT00923195|P1|Participant Flow|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430756|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430757|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430758|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430759|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430760|NCT00923195|E2|Reported Event|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430761|NCT00923195|E1|Reported Event|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
430764|NCT00923156|B2|Baseline|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430765|NCT00923156|B1|Baseline|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430766|NCT00923156|P3|Participant Flow|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
430767|NCT00923156|P2|Participant Flow|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430768|NCT00923156|P1|Participant Flow|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430769|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430770|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430771|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430772|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430773|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430774|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430775|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
430776|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430777|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430778|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
431317|NCT00921557|B4|Baseline|Total|Total of all reporting groups
430780|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430781|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
430782|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430783|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430784|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
430785|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430786|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430787|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
430788|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430789|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430790|NCT00923156|E3|Reported Event|Ramipril + Aliskiren|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
430791|NCT00923156|E2|Reported Event|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
430792|NCT00923156|E1|Reported Event|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
430793|NCT00923130|B1|Baseline|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430794|NCT00923130|P1|Participant Flow|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
431371|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
430795|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430796|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430797|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430798|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430799|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430800|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430801|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430802|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430803|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430804|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430805|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430806|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430807|NCT00923130|O1|Outcome|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430808|NCT00923130|E1|Reported Event|Bevacizumab With Ixabepilone|"Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day~Bevacizumab: Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies. The dose of bevacizumab to be given is 15 mg/kg.~Ixabepilone: Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion. The dose will be 6 mg/m(2)/day on five successive days."
430809|NCT00923117|B3|Baseline|Total|Total of all reporting groups
430810|NCT00923117|B2|Baseline|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
430811|NCT00923117|B1|Baseline|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
430812|NCT00923117|P2|Participant Flow|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
430813|NCT00923117|P1|Participant Flow|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab. Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
430814|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
430815|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
430816|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
430817|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
430818|NCT00923117|E2|Reported Event|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
430819|NCT00923117|E1|Reported Event|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
430820|NCT00923091|B9|Baseline|Total|Total of all reporting groups
430821|NCT00923091|B8|Baseline|Olmesartan/Amlodipine 40mg/10mg|
430822|NCT00923091|B7|Baseline|Olmesartan/Amlodipine 40mg/5mg|
430823|NCT00923091|B6|Baseline|Olmesartan/Amlodipine 20mg/5mg|
430824|NCT00923091|B5|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
430825|NCT00923091|B4|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
430826|NCT00923091|B3|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
430827|NCT00923091|B2|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
430828|NCT00923091|B1|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
430829|NCT00923091|P13|Participant Flow|20/5/12.5mg Responder Continued on 20/5/12.5 mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg continued on 20mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
430830|NCT00923091|P12|Participant Flow|OM/AML/HCT 20/5/12.5mg NonResponder Up Titrated to 40/5/12.5mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg were up titrated to 40mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
430831|NCT00923091|P11|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/25mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
430832|NCT00923091|P10|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/12.5mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
430833|NCT00923091|P9|Participant Flow|OM/AML/HCT 40/5/12.5mg Responder Continued on 40/5/12.5 mg|In Period V responders continued on olmesartan/amlodipine/ hydrochlorothiazide 40mg/5mg/12.5 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
430834|NCT00923091|P8|Participant Flow|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
430835|NCT00923091|P7|Participant Flow|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
430836|NCT00923091|P6|Participant Flow|Olmesartan(OM)20mg/Amlodipine (AML)5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
430837|NCT00923091|P5|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide(HCT) 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
430838|NCT00923091|P4|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
430839|NCT00923091|P3|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
430895|NCT00923078|O1|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
430840|NCT00923091|P2|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period IV participants who did not meet the blood pressure goals (<140/90 mm Hg; or <130/80 for participants with diabetes or chronic renal or cardiovascular disease)in Period III were randomized in a 1:2 fashion to OLM/AML/HCTZ 20/5/12.5 or this group.
430841|NCT00923091|P1|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period III, all participants were included in this group. Responders (a participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease) in Period III went directly to Period VI. In Period IV participants who did not meet the blood pressure goals in Period III were randomized in a 1:2 fashion to this group or the OLM/AML/HCTZ 40/5/12.5 group.
430842|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/25 Titrated to 40/10/25|The participants in this arm had their study medication titrated from olmesartan\amlodipine\hydrochlorothiazide 40/5/25 to 40/10/25
430843|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
430844|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
430845|NCT00923091|O2|Outcome|OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
430846|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
430847|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
430848|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
430849|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
430850|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
430851|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
430852|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
430853|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet.~Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
430854|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
430855|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430856|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430857|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430858|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
430859|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430860|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
430861|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430862|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430863|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430864|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430865|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430866|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
430867|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430868|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
430869|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430870|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430871|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430872|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430873|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
430874|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
430875|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430876|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
430877|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430878|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
430879|NCT00923091|E8|Reported Event|Olmesartan/Amlodipine 40mg/10mg|
430880|NCT00923091|E7|Reported Event|Olmesartan/Amlodipine 40mg/5mg|
430881|NCT00923091|E6|Reported Event|Olmesartan/Amlodipine 20mg/5mg|
430882|NCT00923091|E5|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
430883|NCT00923091|E4|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
430884|NCT00923091|E3|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
430885|NCT00923091|E2|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
430886|NCT00923091|E1|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
430887|NCT00923078|B4|Baseline|Total|Total of all reporting groups
430888|NCT00923078|B3|Baseline|Healthy Comparison|N = 20 healthy community volunteers participated in a single test session to provide normative comparison data
430889|NCT00923078|B2|Baseline|Visual-Auditory Train Order|N = 20 participants with schizophrenia randomized to 4 weeks (20 sessions) of visual training (Insight) followed by 4 weeks (20 sessions) of auditory training (Brain Fitness)
430890|NCT00923078|B1|Baseline|Auditory-Visual Train Order|N = 20 participants with schizophrenia randomized to 4 weeks (20 sessions) of auditory training (Brain Fitness) followed by 4 weeks (20 sessions) of visual training (Insight)
430891|NCT00923078|P3|Participant Flow|Healthy Comparison|A sample healthy community volunteers participated in a single test session to provide normative comparison data on neurophysiological (P300, MMN) outcome measures
430892|NCT00923078|P2|Participant Flow|Visual Then Auditory Cognitive Training|20 individuals with schizophrenia randomized to 4 weeks (20 sessions) of visual training (Insight) followed by 4 weeks (20 sessions) of auditory training (Brain Fitness).
430893|NCT00923078|P1|Participant Flow|Auditory Then Visual Cognitive Training|20 individuals with schizophrenia randomized to 4 weeks (20 sessions) of auditory training (Brain Fitness) followed by 4 weeks (20 sessions) of visual training (Insight).
431226|NCT00922272|E2|Reported Event|SPD489 (Double-blind Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
430896|NCT00923078|O2|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
430897|NCT00923078|O1|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
430898|NCT00923078|O2|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
430899|NCT00923078|O1|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
430900|NCT00923078|O2|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
430901|NCT00923078|O1|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
430902|NCT00923078|O2|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
430903|NCT00923078|O1|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
430904|NCT00923078|O2|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
430905|NCT00923078|O1|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
430906|NCT00923078|O2|Outcome|Visual Cognitive Training|4 weeks (20 sessions) of visual cognitive training (Insight) completed either before or following 4 weeks (20 sessions) of auditory cognitive training (Brain Fitness)
430907|NCT00923078|O1|Outcome|Auditory Cognitive Training|4 weeks (20 sessions) of auditory cognitive training (Brain Fitness) completed either before or following 4 weeks (20 sessions) of visual cognitive training (Insight)
430908|NCT00923078|E3|Reported Event|Healthy Comparison|N = 20 healthy community volunteers participated in a single test session to provide normative comparison data
430909|NCT00923078|E2|Reported Event|Visual Cognitive Training|Individuals with schizophrenia randomized to 4 weeks (20 sessions) of visual training (Insight)
430910|NCT00923078|E1|Reported Event|Auditory Cognitive Training|Individuals with schizophrenia randomized to 4 weeks (20 sessions) of auditory training (Brain Fitness)
430911|NCT00922987|B1|Baseline|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430912|NCT00922987|P1|Participant Flow|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430913|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430914|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430915|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430916|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430917|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430918|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430919|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430920|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430921|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430922|NCT00922987|E1|Reported Event|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
430923|NCT00922935|B4|Baseline|Total|Total of all reporting groups
430924|NCT00922935|B3|Baseline|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
430925|NCT00922935|B2|Baseline|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
430926|NCT00922935|B1|Baseline|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
430927|NCT00922935|P3|Participant Flow|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
430928|NCT00922935|P2|Participant Flow|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
430929|NCT00922935|P1|Participant Flow|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
430930|NCT00922935|O3|Outcome|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
430949|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430931|NCT00922935|O2|Outcome|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
430932|NCT00922935|O1|Outcome|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
430933|NCT00922935|E3|Reported Event|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
430934|NCT00922935|E2|Reported Event|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
430935|NCT00922935|E1|Reported Event|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
430936|NCT00922779|B1|Baseline|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
430937|NCT00922779|P1|Participant Flow|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
430938|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
430939|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
430940|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
430941|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
430942|NCT00922779|E1|Reported Event|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
430943|NCT00922766|B1|Baseline|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430944|NCT00922766|P1|Participant Flow|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430945|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430946|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430947|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430948|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
436216|NCT00909181|P1|Participant Flow|Oxybutynin Gel 56 mg/Day|
430950|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430951|NCT00922766|E1|Reported Event|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
430952|NCT00922701|B1|Baseline|Peritoneal Dialysis Solution|The enrolled patients were using for the long dwell (nocturnal) exchange a glucose-based (2.5% w/v) peritoneal dialysis solution.
430953|NCT00922701|P1|Participant Flow|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
430954|NCT00922701|O1|Outcome|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
430955|NCT00922701|E1|Reported Event|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
430956|NCT00922636|B6|Baseline|Total|Total of all reporting groups
430957|NCT00922636|B5|Baseline|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430958|NCT00922636|B4|Baseline|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430959|NCT00922636|B3|Baseline|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430960|NCT00922636|B2|Baseline|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430961|NCT00922636|B1|Baseline|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430962|NCT00922636|P5|Participant Flow|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430963|NCT00922636|P4|Participant Flow|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430964|NCT00922636|P3|Participant Flow|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430965|NCT00922636|P2|Participant Flow|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430966|NCT00922636|P1|Participant Flow|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430967|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430968|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430969|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430970|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430971|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430972|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430973|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431162|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
430974|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430975|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430976|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430977|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430978|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430979|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430980|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430981|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430982|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430983|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430984|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430985|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430986|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430987|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430988|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430989|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430990|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430991|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430992|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430993|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430994|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430995|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431163|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
436217|NCT00909181|O3|Outcome|Placebo Gel|
430996|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
430997|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
430998|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
430999|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431000|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431001|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431002|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431003|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431004|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431005|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431006|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431007|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431008|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431009|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431010|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431011|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431012|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431013|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431014|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431015|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431016|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431017|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431164|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
431018|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431019|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431020|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431021|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431022|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431023|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431024|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431025|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431026|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431027|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431028|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431029|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431030|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431031|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431032|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431033|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431034|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431035|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431036|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431037|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431038|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431039|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
436218|NCT00909181|O2|Outcome|Oxybutynin Gel 84 mg/Day|
431040|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431041|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431042|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431043|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431044|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431045|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431046|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431047|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431048|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431049|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431050|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431051|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431052|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431053|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431054|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431055|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431056|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431057|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431058|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431059|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431060|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431061|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431225|NCT00922272|E3|Reported Event|Placebo (Double-blind Phase)|Subjects receive placebo once-daily
431062|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431063|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431064|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431065|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431066|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431067|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431068|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431069|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431070|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431071|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431072|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431073|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431074|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431075|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431076|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431077|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431078|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431079|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431080|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431081|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431082|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431083|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431372|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
431084|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431085|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431086|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431087|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431088|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431089|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431090|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431091|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431092|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431093|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
431094|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431095|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431096|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431097|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431098|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431099|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431100|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431101|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
431102|NCT00922636|E10|Reported Event|Methylphenidate - Taper Phase|Participants were given the placebo in capsule form QD po for the 2-week taper phase.
431103|NCT00922636|E9|Reported Event|LY2216684 (0.3 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
431104|NCT00922636|E8|Reported Event|LY2216684 (0.2 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in taper phase.
431105|NCT00922636|E7|Reported Event|LY2216684 (0.1 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
431106|NCT00922636|E6|Reported Event|Placebo - Taper Phase|Methylphenidate blind: Participants were given the placebo in capsule form QD po for the 2-week taper phase.
431107|NCT00922636|E5|Reported Event|Methylphenidate - Treatment Phase|Participants were given 18 mg/day to 54 mg/day of extended-release methylphenidate capsules, based on weight QD po for the 8-week double-blind treatment phase. Participants were also given placebo tablets to maintain LY2216684 blinding.
431108|NCT00922636|E4|Reported Event|LY2216684 (0.3 mg/kg/Day) - Treatment Phase|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431373|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
431109|NCT00922636|E3|Reported Event|LY2216684 (0.2 mg/kg/Day) - Treatment Phase|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431110|NCT00922636|E2|Reported Event|LY2216684 (0.1 mg/kg/Day) - Treatment Phase|Participants were given 0.1 milligrams per kilogram per day (mg/kg/day) of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
431111|NCT00922636|E1|Reported Event|Placebo - Treatment Phase|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase.
431112|NCT00922623|B1|Baseline|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
431113|NCT00922623|P1|Participant Flow|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
431114|NCT00922623|O2|Outcome|Belotero, Right Nasolabial Fold|Belotero injected into the Right Nasolabial Fold of the Face
431115|NCT00922623|O1|Outcome|Belotero, Left Nasolabial Fold|Belotero injected into the Left Nasolabial Fold of the Face
431116|NCT00922623|E2|Reported Event|Belotero, Right Nasolabial Fold|
431117|NCT00922623|E1|Reported Event|Belotero, Left Nasolabial Fold|
431118|NCT00922480|B3|Baseline|Total|Total of all reporting groups
431119|NCT00922480|B2|Baseline|Test: Fimasartan|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
431120|NCT00922480|B1|Baseline|Control: Losartan|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
431121|NCT00922480|P2|Participant Flow|Test: Fimasartan|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
431122|NCT00922480|P1|Participant Flow|Control: Losartan|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
431123|NCT00922480|O2|Outcome|Test: Fimasartan / Week 4,8 -ITT|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
431124|NCT00922480|O1|Outcome|Control: Losartan / Week 4,8 -ITT|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
431125|NCT00922480|O2|Outcome|Test: Fimasartan / Week 12 -ITT|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
431126|NCT00922480|O1|Outcome|Control: Losartan / Week 12 -ITT|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
431127|NCT00922480|E2|Reported Event|Test: Fimasartan|"Fimasartan 60mg, 120mg~Fimasartan: Fimasartan 60 ~ 120mg/po take one tablets once a day"
431128|NCT00922480|E1|Reported Event|Control: Losartan|"Losartan group~Losartan (Control): Losartan 50 mg ~ 100 mg/po, take one tablets once a day"
431129|NCT00922441|B4|Baseline|Total|Total of all reporting groups
431130|NCT00922441|B3|Baseline|Valsartan: Control|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
431131|NCT00922441|B2|Baseline|Fimasartan 2|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
431132|NCT00922441|B1|Baseline|Fimasartan 1|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
431133|NCT00922441|P3|Participant Flow|Valsartan: Control|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
431134|NCT00922441|P2|Participant Flow|Fimasartan 2|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
431135|NCT00922441|P1|Participant Flow|Fimasartan 1|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
431136|NCT00922441|O3|Outcome|Valsartan: Control-ITT|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
431137|NCT00922441|O2|Outcome|Fimasartan 2-ITT|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
431138|NCT00922441|O1|Outcome|Fimasartan 1-ITT|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
431139|NCT00922441|E3|Reported Event|Valsartan: Control|"Reference (Valsartan 80 mg) group~Valsartan 80 mg daily, po"
431140|NCT00922441|E2|Reported Event|Fimasartan 2|"Fimasartan 120 mg group~Fimasartan 120 mg daily, po"
431141|NCT00922441|E1|Reported Event|Fimasartan 1|"Fimasartan 60 mg group~Fimasartan 60 mg daily, po"
431142|NCT00922428|B1|Baseline|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
431143|NCT00922428|P1|Participant Flow|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
431144|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
431145|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
431146|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
431147|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
431148|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
431149|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
431150|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
431151|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
431152|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
431153|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
431154|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
431155|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
431156|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
431157|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
431158|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
431159|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
431160|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
431161|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
431165|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
431166|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
431167|NCT00922428|O3|Outcome|Observational Group (Visit 3)|VAS of the observational group at visit 3
431168|NCT00922428|O2|Outcome|Observational Group (Visit 2)|VAS of the observational group at visit 2
431169|NCT00922428|O1|Outcome|Observational (Visit 1)|VAS of the observational group at beginning
431170|NCT00922428|E1|Reported Event|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
431171|NCT00922272|B1|Baseline|Overall|Constitutes all subjects contained in the Safety Analysis Set defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.
431172|NCT00922272|P2|Participant Flow|Placebo|Subjects received placebo once-daily for 4 weeks during the Double-blind Phase to a stable dose of atypical antipsychotic medication.
431173|NCT00922272|P1|Participant Flow|SPD489|The study consisted of a 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication. They were then randomized into the Double-Blind Phase receiving either their optimal dose of adjunctive SPD489 or placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431174|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431175|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431176|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431177|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431178|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431179|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431180|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431181|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431182|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431183|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431184|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431185|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431186|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431187|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431188|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431189|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431190|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431191|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431192|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431193|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431194|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431195|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431196|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431197|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431198|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431199|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431200|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431201|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431202|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431203|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431204|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431205|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431206|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431207|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431208|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431209|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431210|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431211|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431212|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431213|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431214|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431215|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431216|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431217|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431218|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431219|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431220|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431221|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431222|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
431223|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431224|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
431227|NCT00922272|E1|Reported Event|SPD489 (Open-label Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
431228|NCT00922233|B1|Baseline|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
431229|NCT00922233|P1|Participant Flow|Levonorgestrel|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
431230|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
431231|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
431232|NCT00922233|O1|Outcome|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills
431233|NCT00922233|E1|Reported Event|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
431234|NCT00922207|B4|Baseline|Total|Total of all reporting groups
431235|NCT00922207|B3|Baseline|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431236|NCT00922207|B2|Baseline|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431237|NCT00922207|B1|Baseline|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431238|NCT00922207|P3|Participant Flow|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431239|NCT00922207|P2|Participant Flow|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir (Baraclude) 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431240|NCT00922207|P1|Participant Flow|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431241|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431242|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431243|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431244|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431245|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431246|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431247|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431248|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431271|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
436219|NCT00909181|O1|Outcome|Oxybutynin Gel 56 mg/Day|
431249|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431250|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431251|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431252|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431253|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431254|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431255|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431256|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431257|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431258|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431259|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431260|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431261|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431262|NCT00922207|E3|Reported Event|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431263|NCT00922207|E2|Reported Event|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431264|NCT00922207|E1|Reported Event|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
431265|NCT00922194|B1|Baseline|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431266|NCT00922194|P1|Participant Flow|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431267|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431268|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431269|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431270|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431272|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431273|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431274|NCT00922194|E1|Reported Event|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
431275|NCT00922116|B1|Baseline|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431276|NCT00922116|P1|Participant Flow|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431277|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431278|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431279|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431280|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431281|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431282|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431283|NCT00922116|E1|Reported Event|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
431284|NCT00921947|B3|Baseline|Total|Total of all reporting groups
431285|NCT00921947|B2|Baseline|VAX102 SC|Given as 2 µg subcutaneous
431286|NCT00921947|B1|Baseline|VAX102 IM|Given as 1 µg intramuscular
431287|NCT00921947|P2|Participant Flow|VAX102 SC|Given as 2 µg subcutaneous
431288|NCT00921947|P1|Participant Flow|VAX102 IM|Given as 1 µg intramuscular
431289|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
431290|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
431291|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
431292|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
431293|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
431294|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
431295|NCT00921947|E2|Reported Event|VAX102 SC|Given as 2 µg subcutaneous
431296|NCT00921947|E1|Reported Event|VAX102 IM|Given as 1 µg intramuscular
431297|NCT00921934|B1|Baseline|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
431298|NCT00921934|P1|Participant Flow|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
431299|NCT00921934|O1|Outcome|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
431300|NCT00921934|E1|Reported Event|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
431301|NCT00921895|B1|Baseline|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
431302|NCT00921895|P1|Participant Flow|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
431303|NCT00921895|O2|Outcome|RPS Adeno Detector IV (Specificity)|Looking for the number of true negatives as compared to cell culture.
431304|NCT00921895|O1|Outcome|RPS Adeno Detector IV (Sensitivity)|Looking for the number of true positives as compared to cell culture.
431305|NCT00921895|E1|Reported Event|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
431306|NCT00921687|B3|Baseline|Total|Total of all reporting groups
431307|NCT00921687|B2|Baseline|Intervention Clinic|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
431308|NCT00921687|B1|Baseline|Control Clinic|Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card).
431309|NCT00921687|P2|Participant Flow|Intervention|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
431310|NCT00921687|P1|Participant Flow|Control|Providers in the control group received education only (CKD lecture and a CKD reference card).
431311|NCT00921687|O2|Outcome|Intervention Clinic|
431312|NCT00921687|O1|Outcome|Control Clinic|
431313|NCT00921687|O2|Outcome|Intervention Clinic|
431314|NCT00921687|O1|Outcome|Control Clinic|
431315|NCT00921687|E2|Reported Event|Intervention Clinic|
431316|NCT00921687|E1|Reported Event|Control Clinic|
431318|NCT00921557|B3|Baseline|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431319|NCT00921557|B2|Baseline|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431320|NCT00921557|B1|Baseline|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431321|NCT00921557|P3|Participant Flow|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431322|NCT00921557|P2|Participant Flow|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431323|NCT00921557|P1|Participant Flow|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431324|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431325|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431326|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431327|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431328|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431329|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431330|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431331|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431332|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431333|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431334|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431335|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431336|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431337|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431338|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431339|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431340|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431341|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431342|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431343|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431344|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431345|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431346|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431347|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431348|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431349|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431350|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431351|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431352|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431353|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431354|NCT00921557|O3|Outcome|1B: Alendronate/Placebo (96 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
431355|NCT00921557|O2|Outcome|2: Placebo/Alendronate (48 Week Change)|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431356|NCT00921557|O1|Outcome|1B: Alendronate/Placebo (48 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
431357|NCT00921557|O3|Outcome|1B: Alendronate/Placebo (96 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
431358|NCT00921557|O2|Outcome|2: Placebo/Alendronate (48 Week Change)|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431359|NCT00921557|O1|Outcome|1B: Alendronate/Placebo (48 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
431360|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
431361|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
431362|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
431363|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
431364|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431365|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431366|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431367|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431368|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431369|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431370|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
431374|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
431375|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
431376|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
431377|NCT00921557|E3|Reported Event|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
431378|NCT00921557|E2|Reported Event|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
431379|NCT00921557|E1|Reported Event|1A: Alendronate/Alendronate|Participants received alendronate for 48 weeks
431380|NCT00921518|B3|Baseline|Total|Total of all reporting groups
431381|NCT00921518|B2|Baseline|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431382|NCT00921518|B1|Baseline|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431383|NCT00921518|P2|Participant Flow|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431384|NCT00921518|P1|Participant Flow|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431385|NCT00921518|O2|Outcome|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431386|NCT00921518|O1|Outcome|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431387|NCT00921518|E2|Reported Event|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431388|NCT00921518|E1|Reported Event|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
431389|NCT00921310|B3|Baseline|Total|Total of all reporting groups
431390|NCT00921310|B2|Baseline|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431391|NCT00921310|B1|Baseline|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431392|NCT00921310|P3|Participant Flow|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431393|NCT00921310|P2|Participant Flow|Phase I Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431394|NCT00921310|P1|Participant Flow|Phase I Dose Level 1 (Pemetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
432071|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
431395|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431396|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431397|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431398|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431399|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431400|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431401|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431402|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431403|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431404|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431405|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431406|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431407|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431408|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431409|NCT00921310|O3|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431410|NCT00921310|O2|Outcome|Phase 1 Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431411|NCT00921310|O1|Outcome|Phase I Dose Level 1 (Premetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431412|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431413|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431414|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431415|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431416|NCT00921310|E2|Reported Event|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
431417|NCT00921310|E1|Reported Event|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
431418|NCT00921115|B1|Baseline|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
431615|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
436220|NCT00909181|E3|Reported Event|Placebo Gel|
431419|NCT00921115|P1|Participant Flow|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
431420|NCT00921115|O1|Outcome|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
431421|NCT00921115|E1|Reported Event|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
431422|NCT00921024|B3|Baseline|Total|Total of all reporting groups
431423|NCT00921024|B2|Baseline|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
431424|NCT00921024|B1|Baseline|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
431425|NCT00921024|P2|Participant Flow|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
431426|NCT00921024|P1|Participant Flow|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
431427|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
431428|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
431429|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
431430|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
431431|NCT00921024|E2|Reported Event|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
431432|NCT00921024|E1|Reported Event|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
431433|NCT00920907|B3|Baseline|Total|Total of all reporting groups
431434|NCT00920907|B2|Baseline|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431435|NCT00920907|B1|Baseline|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431436|NCT00920907|P2|Participant Flow|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431437|NCT00920907|P1|Participant Flow|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
431438|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431439|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431440|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431441|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431616|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
432072|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
431442|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431443|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431444|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431445|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431446|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431447|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431448|NCT00920907|O2|Outcome|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431449|NCT00920907|O1|Outcome|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
431450|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431451|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431452|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431453|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431454|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431455|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431456|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431457|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431458|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431459|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431460|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
432073|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
431461|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431462|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431463|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431464|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431465|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431466|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431467|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431468|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431469|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431470|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431471|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431472|NCT00920907|E2|Reported Event|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
431473|NCT00920907|E1|Reported Event|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
431474|NCT00920855|B4|Baseline|Total|Total of all reporting groups
431475|NCT00920855|B3|Baseline|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431476|NCT00920855|B2|Baseline|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431477|NCT00920855|B1|Baseline|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431478|NCT00920855|P3|Participant Flow|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431479|NCT00920855|P2|Participant Flow|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431480|NCT00920855|P1|Participant Flow|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431481|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431482|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431483|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431484|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
431485|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
431486|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
431487|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
431488|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
431489|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431490|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431491|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431492|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431493|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431494|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431495|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431496|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431497|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431498|NCT00920855|E3|Reported Event|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431499|NCT00920855|E2|Reported Event|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431500|NCT00920855|E1|Reported Event|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
431501|NCT00920816|B5|Baseline|Total|Total of all reporting groups
431502|NCT00920816|B4|Baseline|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431503|NCT00920816|B3|Baseline|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431504|NCT00920816|B2|Baseline|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431505|NCT00920816|B1|Baseline|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431506|NCT00920816|P4|Participant Flow|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431507|NCT00920816|P3|Participant Flow|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431508|NCT00920816|P2|Participant Flow|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431509|NCT00920816|P1|Participant Flow|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431617|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD.
436221|NCT00909181|E2|Reported Event|Oxybutynin Gel 84 mg/Day|
431510|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431511|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431512|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431513|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431514|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431515|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431516|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431517|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431518|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431519|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431520|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431521|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431522|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431523|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431524|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431525|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431526|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431527|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431528|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431529|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431618|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
436222|NCT00909181|E1|Reported Event|Oxybutynin Gel 56 mg/Day|
431530|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431531|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431532|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431533|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431534|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431535|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431536|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431537|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431538|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431539|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431540|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431541|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431542|NCT00920816|E4|Reported Event|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431543|NCT00920816|E3|Reported Event|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431544|NCT00920816|E2|Reported Event|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431545|NCT00920816|E1|Reported Event|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
431546|NCT00920790|B1|Baseline|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431547|NCT00920790|P1|Participant Flow|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431548|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431549|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431550|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431551|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431552|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431553|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431554|NCT00920790|E1|Reported Event|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
431555|NCT00920699|B4|Baseline|Total|Total of all reporting groups
431619|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431620|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431621|NCT00920647|O1|Outcome|Control|Untreated Patients
431622|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431556|NCT00920699|B3|Baseline|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431557|NCT00920699|B2|Baseline|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431558|NCT00920699|B1|Baseline|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431559|NCT00920699|P3|Participant Flow|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431560|NCT00920699|P2|Participant Flow|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431561|NCT00920699|P1|Participant Flow|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431562|NCT00920699|O3|Outcome|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431563|NCT00920699|O2|Outcome|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431564|NCT00920699|O1|Outcome|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431565|NCT00920699|O3|Outcome|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431566|NCT00920699|O2|Outcome|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431567|NCT00920699|O1|Outcome|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431568|NCT00920699|O3|Outcome|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431623|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431624|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431625|NCT00920647|O1|Outcome|Control|Untreated Patients
431626|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431569|NCT00920699|O2|Outcome|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431570|NCT00920699|O1|Outcome|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431571|NCT00920699|E3|Reported Event|2400 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431572|NCT00920699|E2|Reported Event|1200 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431573|NCT00920699|E1|Reported Event|600 mg Per Day of CoQ10|"All participants will start on a dosage of 600 mg/day of CoQ10 in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.~CoQ10: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20."
431574|NCT00920686|B4|Baseline|Total|Total of all reporting groups
431575|NCT00920686|B3|Baseline|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
431576|NCT00920686|B2|Baseline|NXN-188 600 mg|3 x 200 mg capsules
431577|NCT00920686|B1|Baseline|Placebo|3 x 0 mg capsules
431578|NCT00920686|P3|Participant Flow|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
431579|NCT00920686|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules
431580|NCT00920686|P1|Participant Flow|Placebo|3 x 0 mg capsules
431581|NCT00920686|O3|Outcome|Sumatriptan Succinate|1 x 100 mg, 2 x 0 mg capsules
431582|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
431583|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
431584|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
431585|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
431586|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
431587|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
431588|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
431589|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
431590|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
431591|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
431592|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
431593|NCT00920686|O3|Outcome|Sumatriptan Succinate|100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
431594|NCT00920686|O2|Outcome|NXN-188|600 mg of NXN-188 provided as 3 x 200 mg capsules.
431595|NCT00920686|O1|Outcome|Placebo|Three capsules containing placebo
431596|NCT00920686|E3|Reported Event|Sumatriptan Succinate|100 mg sumatriptan. Three capsules, one containing 100 mg sumatriptan succinate and two placebo-containing capsules were provided. All capsules were taken at the same time.
431597|NCT00920686|E2|Reported Event|NXN-188|600 mg NXN-188. Three capsules each containing 200 mg of NXN-188 were provided. All capsules were taken at the same time.
431598|NCT00920686|E1|Reported Event|Placebo|Three placebo capsules were provided. All capsules were taken at the same time.
431599|NCT00920647|B5|Baseline|Total|Total of all reporting groups
431600|NCT00920647|B4|Baseline|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431601|NCT00920647|B3|Baseline|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431602|NCT00920647|B2|Baseline|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431603|NCT00920647|B1|Baseline|Control|Untreated Patients
431604|NCT00920647|P4|Participant Flow|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431605|NCT00920647|P3|Participant Flow|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431606|NCT00920647|P2|Participant Flow|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431607|NCT00920647|P1|Participant Flow|Control|Untreated Patients
431608|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431609|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431610|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431611|NCT00920647|O1|Outcome|Control|Untreated Patients, Observed Value
431612|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 36 hours post drug administration"
431613|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 24 hours post drug administration"
431614|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 36 hours post drug administration."
431627|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431628|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431629|NCT00920647|O1|Outcome|Control|Untreated Patients
431630|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431631|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431632|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431633|NCT00920647|O1|Outcome|Control|Untreated Patients
431634|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431635|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431636|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431637|NCT00920647|O1|Outcome|Control|
431638|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431639|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431640|NCT00920647|O2|Outcome|Idursulfase IT (1mg)|monthly using an intrathecal drug delivery device (IDDD)
431641|NCT00920647|O1|Outcome|Control|Untreated Patients
431642|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431643|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431644|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431645|NCT00920647|O1|Outcome|Control|Untreated Patients for 6 months, Observed Value
431646|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431647|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431648|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431649|NCT00920647|O1|Outcome|Control|Untreated Patients
431650|NCT00920647|E4|Reported Event|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
431651|NCT00920647|E3|Reported Event|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
431652|NCT00920647|E2|Reported Event|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
431653|NCT00920647|E1|Reported Event|Control|Untreated Patients
431654|NCT00920621|B5|Baseline|Total|Total of all reporting groups
431655|NCT00920621|B4|Baseline|Placebo (Children)|"Children of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
431656|NCT00920621|B3|Baseline|Vitamin D Treatment (Children)|Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
431657|NCT00920621|B2|Baseline|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
431658|NCT00920621|B1|Baseline|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
431659|NCT00920621|P4|Participant Flow|Placebo (Offspring)|"Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control"
431660|NCT00920621|P3|Participant Flow|Vitamin D Treatment (Offspring)|Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
431661|NCT00920621|P2|Participant Flow|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
431662|NCT00920621|P1|Participant Flow|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
431663|NCT00920621|O2|Outcome|Placebo|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
431664|NCT00920621|O1|Outcome|Vitamin D Treatment|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
431665|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
431666|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
431667|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
431668|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
431669|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
431670|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
431671|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
431672|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
431673|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
431674|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
431675|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
431676|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
431677|NCT00920621|O2|Outcome|Placebo|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
431678|NCT00920621|O1|Outcome|Vitamin D Treatment|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
431679|NCT00920621|O2|Outcome|Placebo|Children of mother's assigned 400 IU Vitamin D.
431680|NCT00920621|O1|Outcome|Vitamin D Treatment|Children of mother's assigned 4400 IU Vitamin D
431681|NCT00920621|E4|Reported Event|Placebo (Offspring)|"Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
431682|NCT00920621|E3|Reported Event|Vitamin D Treatment (Offspring)|Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
431683|NCT00920621|E2|Reported Event|Placebo (Mothers)|"Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the Control (providing the current standard of care during pregnancy)."
431684|NCT00920621|E1|Reported Event|Vitamin D Treatment (Mothers)|Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
431685|NCT00920439|B1|Baseline|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
431686|NCT00920439|P1|Participant Flow|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
431687|NCT00920439|O1|Outcome|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
431688|NCT00920439|O1|Outcome|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
431689|NCT00920439|O1|Outcome|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
431690|NCT00920439|O1|Outcome|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
431691|NCT00920439|E1|Reported Event|Poliorix Group|Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
431692|NCT00920426|B4|Baseline|Total|Total of all reporting groups
431693|NCT00920426|B3|Baseline|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431694|NCT00920426|B2|Baseline|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431695|NCT00920426|B1|Baseline|GSK1265744 30 mg|GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
431696|NCT00920426|P4|Participant Flow|Optimized Therapy|Participants were given investigator chosen optimized therapy for 14 days after being dosed with the randomized regimen (either 5 mg GSK1265744 or Placebo) for 10 days. Participants were unblinded on Day 11 so that the participants receiving Placebo could decline optimized therapy.
431697|NCT00920426|P3|Participant Flow|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431698|NCT00920426|P2|Participant Flow|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431699|NCT00920426|P1|Participant Flow|GSK1265744 30 mg|GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
431700|NCT00920426|O1|Outcome|Pooled GSK1265744|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
431701|NCT00920426|O1|Outcome|Pooled GSK1265744|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
431702|NCT00920426|O1|Outcome|Pooled GSK1265744|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
431703|NCT00920426|O1|Outcome|Pooled GSK1265744|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
431704|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431705|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431706|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431707|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431708|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431709|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431710|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431711|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431712|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431713|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431714|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431715|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431716|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431717|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
436223|NCT00909155|B4|Baseline|Total|Total of all reporting groups
431718|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431719|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431720|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431721|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431722|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431723|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431724|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431725|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431726|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431727|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431728|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431729|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431730|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431731|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg tablet once daily for 10 days.
431732|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431733|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days.
431734|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431735|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431736|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431737|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431738|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431739|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431740|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431741|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431742|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431743|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431744|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431745|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431746|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431747|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431748|NCT00920426|O3|Outcome|Optimized Therapy|Participants were given investigator chosen optimized therapy for 14 days after being dosed with the randomized regimen (either 5 mg GSK1265744 or Placebo) for 10 days. Participants were unblinded on Day 11 so that the participants receiving Placebo could decline optimized therapy.
431749|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431750|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431751|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431752|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431753|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431754|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431755|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431756|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431757|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431758|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431759|NCT00920426|O2|Outcome|Placebo|Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
431760|NCT00920426|O1|Outcome|GSK1265744 5 mg|Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
431761|NCT00920426|E4|Reported Event|Optimized Therapy|Participants were given investigator chosen optimized therapy for 14 days after being dosed with the randomized regimen (either 5 mg GSK1265744 or Placebo) for 10 days. Participants were unblinded on Day 11 so that the participants receiving Placebo could decline optimized therapy.
431762|NCT00920426|E3|Reported Event|Placebo|Eligible participants received double-blind Placebo matching 5 mg GSK1265744 oral tablet once daily for 10 days.
432068|NCT00919711|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
431763|NCT00920426|E2|Reported Event|GSK1265744 5 mg|Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days.
431764|NCT00920426|E1|Reported Event|GSK1265744 30 mg|GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
431765|NCT00920374|B3|Baseline|Total|Total of all reporting groups
431766|NCT00920374|B2|Baseline|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431767|NCT00920374|B1|Baseline|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431768|NCT00920374|P2|Participant Flow|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431769|NCT00920374|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431770|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431771|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431772|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431773|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431774|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431775|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431776|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431777|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431778|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431779|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431780|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431781|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431782|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431783|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431784|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431785|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431786|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431787|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431788|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431789|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431790|NCT00920374|E2|Reported Event|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
431791|NCT00920374|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
431792|NCT00920309|B3|Baseline|Total|Total of all reporting groups
431793|NCT00920309|B2|Baseline|Standard of Care-Placebo|
431794|NCT00920309|B1|Baseline|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
431795|NCT00920309|P2|Participant Flow|Standard of Care-Placebo|
431796|NCT00920309|P1|Participant Flow|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
431797|NCT00920309|O2|Outcome|Standard of Care-Placebo|
431798|NCT00920309|O1|Outcome|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
431799|NCT00920309|O2|Outcome|Standard of Care-Placebo|
431800|NCT00920309|O1|Outcome|Rapamycin|The study was terminated before any enrolled patients were treated for 2 years.
431801|NCT00920309|E2|Reported Event|Standard of Care-Placebo|
431802|NCT00920309|E1|Reported Event|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
431803|NCT00920231|B3|Baseline|Total|Total of all reporting groups
431804|NCT00920231|B2|Baseline|Modified System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
431805|NCT00920231|B1|Baseline|Initial System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
431806|NCT00920231|P2|Participant Flow|Modified Computer Vision System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
431807|NCT00920231|P1|Participant Flow|Initial Computer Vision System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
431808|NCT00920231|O2|Outcome|Modified System|this computer vision system incorporates the needed changes identified by the first group of subjects using the initial prototype system.
431809|NCT00920231|O1|Outcome|Initial Prototype|The initial prototype is a system that has been successfully tested in outdoor navigation and successfully tested for simple object recognition.
431810|NCT00920231|O2|Outcome|Modified System|a second group of 8 subjects were tested with a system that incorporated modifications identified by the first group using the initial prototype system.
431811|NCT00920231|O1|Outcome|Initial System|The subjects were asked to travel over a novel path in the hospital after given instructions how to reach the final destination. the computer vision system was used to provide additional information as when to turn and in what direction. the subjects were allowed to also use their white cane
431812|NCT00920231|E2|Reported Event|Arm 2|"The subject without the assist device can only locate the object by groping and random searching with hands.~No adverse events"
431813|NCT00920231|E1|Reported Event|Arm 1|"the blind subject is asked to locate a randomly placed object with the assistance of the webcam/laptop computer.~computer vision: a webcam-laptop based system to assist the blind in locating objects and in way finding.~No adverse events"
431814|NCT00920218|B5|Baseline|Total|Total of all reporting groups
431815|NCT00920218|B4|Baseline|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431816|NCT00920218|B3|Baseline|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431817|NCT00920218|B2|Baseline|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431818|NCT00920218|B1|Baseline|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431819|NCT00920218|P4|Participant Flow|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431820|NCT00920218|P3|Participant Flow|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431821|NCT00920218|P2|Participant Flow|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431822|NCT00920218|P1|Participant Flow|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431823|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431824|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431825|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431826|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431827|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431828|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431829|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431830|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431831|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431956|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
432069|NCT00919711|P1|Participant Flow|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
431832|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431833|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431834|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431835|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431836|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431837|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431838|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431839|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431840|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431841|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431842|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431843|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431844|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431845|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431846|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431847|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431848|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431849|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431850|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431851|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431957|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431852|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431853|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431854|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431855|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431856|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431857|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431858|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431859|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431860|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule
431861|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431862|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431863|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431864|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431865|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431866|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431867|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431868|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431869|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431870|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431871|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431958|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
438934|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
431872|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431873|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431874|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431875|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431876|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431877|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431878|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431879|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431880|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431881|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431882|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431883|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431884|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431885|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431886|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431887|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431888|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431889|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431890|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431891|NCT00920218|O4|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431959|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431892|NCT00920218|O3|Outcome|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431893|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431894|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431895|NCT00920218|O5|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431896|NCT00920218|O4|Outcome|Placebo 1D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
431897|NCT00920218|O3|Outcome|GSK 1437173A 2D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
431898|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431899|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431900|NCT00920218|O5|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431901|NCT00920218|O4|Outcome|Placebo 1D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
431902|NCT00920218|O3|Outcome|GSK 1437173A 2D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
431903|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431904|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431905|NCT00920218|O5|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431906|NCT00920218|O4|Outcome|Placebo 1D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
431907|NCT00920218|O3|Outcome|GSK 1437173A 2D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
431908|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431909|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431910|NCT00920218|O5|Outcome|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431911|NCT00920218|O4|Outcome|Placebo 1D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
431912|NCT00920218|O3|Outcome|GSK 1437173A 2D Group|Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
431913|NCT00920218|O2|Outcome|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431914|NCT00920218|O1|Outcome|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431915|NCT00920218|E4|Reported Event|Placebo Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431916|NCT00920218|E3|Reported Event|Placebo-GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431917|NCT00920218|E2|Reported Event|GSK 1437173A F2 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431960|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431918|NCT00920218|E1|Reported Event|GSK 1437173A F1 Group|Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
431919|NCT00920140|B6|Baseline|Total|Total of all reporting groups
431920|NCT00920140|B5|Baseline|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
431921|NCT00920140|B4|Baseline|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
431922|NCT00920140|B3|Baseline|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
431923|NCT00920140|B2|Baseline|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431924|NCT00920140|B1|Baseline|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431925|NCT00920140|P5|Participant Flow|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
431926|NCT00920140|P4|Participant Flow|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or chronic myelomonocytic leukemia (CMML) with RAS wild type (wt) or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
431927|NCT00920140|P3|Participant Flow|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplasia (MDS) with rat sarcoma (RAS) mutation received GSK1120212 2 mg OD as a continuous dose.
431928|NCT00920140|P2|Participant Flow|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431929|NCT00920140|P1|Participant Flow|GSK1120212 < 2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431930|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
431931|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
431932|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
431933|NCT00920140|O1|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431934|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431935|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
431936|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
431937|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431938|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
431939|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
431940|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431941|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
431942|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
431943|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431944|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
431945|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
431946|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431947|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
431948|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
431949|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
431950|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
431951|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
431952|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431953|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431954|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431955|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431961|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431962|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431963|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431964|NCT00920140|E2|Reported Event|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
431965|NCT00920140|E1|Reported Event|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
431966|NCT00920075|B1|Baseline|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
431967|NCT00920075|P1|Participant Flow|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
431968|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
431969|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
431970|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
431971|NCT00920075|E1|Reported Event|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
431972|NCT00920023|B1|Baseline|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
431973|NCT00920023|P1|Participant Flow|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
431974|NCT00920023|O1|Outcome|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
431975|NCT00920023|O1|Outcome|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
431976|NCT00920023|E1|Reported Event|SPIO MRI|Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
431977|NCT00919932|B3|Baseline|Total|Total of all reporting groups
431978|NCT00919932|B2|Baseline|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
431979|NCT00919932|B1|Baseline|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
431980|NCT00919932|P2|Participant Flow|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
431981|NCT00919932|P1|Participant Flow|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
432004|NCT00919867|P6|Participant Flow|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
431982|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
431983|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
431984|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
431985|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
431986|NCT00919932|E2|Reported Event|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
431987|NCT00919932|E1|Reported Event|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
431988|NCT00919893|B3|Baseline|Total|Total of all reporting groups
431989|NCT00919893|B2|Baseline|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
431990|NCT00919893|B1|Baseline|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
431991|NCT00919893|P2|Participant Flow|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
431992|NCT00919893|P1|Participant Flow|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
431993|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
431994|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
431995|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
431996|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
431997|NCT00919867|B7|Baseline|Total|Total of all reporting groups
431998|NCT00919867|B6|Baseline|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
431999|NCT00919867|B5|Baseline|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
432000|NCT00919867|B4|Baseline|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
432001|NCT00919867|B3|Baseline|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
432002|NCT00919867|B2|Baseline|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
432003|NCT00919867|B1|Baseline|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
432067|NCT00919711|B1|Baseline|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
432070|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
432005|NCT00919867|P5|Participant Flow|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
432006|NCT00919867|P4|Participant Flow|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
432007|NCT00919867|P3|Participant Flow|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
432008|NCT00919867|P2|Participant Flow|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
432009|NCT00919867|P1|Participant Flow|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
432010|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432011|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
432012|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432013|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
432014|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432015|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
432016|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432017|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
432018|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432019|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
432020|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432021|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
432022|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432023|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
432024|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432025|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
432026|NCT00919867|E3|Reported Event|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
432027|NCT00919867|E2|Reported Event|Vyvanse Alone|Single 50 mg dose
432028|NCT00919867|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
432029|NCT00919854|B1|Baseline|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432030|NCT00919854|P1|Participant Flow|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432031|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432032|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432033|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432034|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432035|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432036|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432037|NCT00919854|E1|Reported Event|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
432038|NCT00919802|B1|Baseline|All Study Participants|Patients will be randomized to receive a single dose of oxytocin 40 IU (20 IU to each nostril) or saline. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described.
432039|NCT00919802|P2|Participant Flow|Intranasal Saline Followed With Intranasal Oxytocin|"Saline, 4ml intranasally, once~Patients will be randomized to receive saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects.~Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time they will receive the alternative intranasal agent, Oxytocin a single dose of oxytocin 40 IU (20 IU to each nostril). Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
432040|NCT00919802|P1|Participant Flow|Intranasal Oxytocin, Followed by Intranasal Saline|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
432041|NCT00919802|O2|Outcome|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
432042|NCT00919802|O1|Outcome|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
432043|NCT00919802|O2|Outcome|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
432044|NCT00919802|O1|Outcome|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
432045|NCT00919802|E2|Reported Event|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
432046|NCT00919802|E1|Reported Event|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
432047|NCT00919763|B3|Baseline|Total|Total of all reporting groups
432048|NCT00919763|B2|Baseline|CD 2027 Vehicle, Twice Daily|Topical Ointment
432049|NCT00919763|B1|Baseline|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
432050|NCT00919763|P2|Participant Flow|CD 2027 Vehicle, Twice Daily|Topical Ointment
432051|NCT00919763|P1|Participant Flow|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
432052|NCT00919763|O2|Outcome|CD 2027 Vehicle, Twice Daily|Topical Ointment
432053|NCT00919763|O1|Outcome|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
432054|NCT00919763|E2|Reported Event|CD 2027 Vehicle, Twice Daily|Topical Ointment
432055|NCT00919763|E1|Reported Event|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
432056|NCT00919724|B3|Baseline|Total|Total of all reporting groups
432057|NCT00919724|B2|Baseline|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
432058|NCT00919724|B1|Baseline|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
432059|NCT00919724|P2|Participant Flow|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
432060|NCT00919724|P1|Participant Flow|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
432061|NCT00919724|O2|Outcome|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
432062|NCT00919724|O1|Outcome|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
432063|NCT00919724|E2|Reported Event|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
432064|NCT00919724|E1|Reported Event|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
432065|NCT00919711|B3|Baseline|Total|Total of all reporting groups
432066|NCT00919711|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
432074|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
432075|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
432076|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
432077|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
432078|NCT00919711|E2|Reported Event|Denosumab 60 mg Q6M|
432079|NCT00919711|E1|Reported Event|Risedronate 150 mg QM|
432080|NCT00919633|B5|Baseline|Total|Total of all reporting groups
432081|NCT00919633|B4|Baseline|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432082|NCT00919633|B3|Baseline|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432083|NCT00919633|B2|Baseline|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432084|NCT00919633|B1|Baseline|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432085|NCT00919633|P4|Participant Flow|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432086|NCT00919633|P3|Participant Flow|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432087|NCT00919633|P2|Participant Flow|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432088|NCT00919633|P1|Participant Flow|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432089|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432090|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432091|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432092|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432093|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432094|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432095|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432096|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432097|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432098|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432099|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432151|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432152|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432100|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432101|NCT00919633|E4|Reported Event|INTRON A 160,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432102|NCT00919633|E3|Reported Event|INTRON A 120,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432103|NCT00919633|E2|Reported Event|INTRON A 80,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432104|NCT00919633|E1|Reported Event|PEGINTRON 1.5|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
432105|NCT00919191|B1|Baseline|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
432106|NCT00919191|P1|Participant Flow|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
432107|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
432108|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split-face model
432109|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
432110|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split face model
432111|NCT00919191|E1|Reported Event|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
432112|NCT00919126|B4|Baseline|Total|Total of all reporting groups
432113|NCT00919126|B3|Baseline|Group C|Medical Air in Oxygen (45%-55%)
432114|NCT00919126|B2|Baseline|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432115|NCT00919126|B1|Baseline|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432116|NCT00919126|P3|Participant Flow|Group C|Medical Air in Oxygen (45%-55%)
432117|NCT00919126|P2|Participant Flow|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432118|NCT00919126|P1|Participant Flow|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432119|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432120|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432121|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432122|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432123|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432124|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432125|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432126|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432127|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432128|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432129|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432130|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432131|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432132|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432133|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432134|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432135|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432136|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432137|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432138|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432139|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432140|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432141|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432142|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432143|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432144|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432145|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432146|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432147|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432148|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432149|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432150|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432153|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
432154|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432155|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
432156|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
432157|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432158|NCT00919126|E3|Reported Event|Group C|Medical Air in Oxygen (45%-55%)
432159|NCT00919126|E2|Reported Event|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
432160|NCT00919126|E1|Reported Event|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
432161|NCT00919113|B3|Baseline|Total|Total of all reporting groups
432162|NCT00919113|B2|Baseline|Placebo|identical buffer
432163|NCT00919113|B1|Baseline|Uracyst|2% sodium chondroitin sulfate
432164|NCT00919113|P2|Participant Flow|Placebo|identical buffer
432165|NCT00919113|P1|Participant Flow|Uracyst|2% sodium chondroitin sulfate
432166|NCT00919113|O2|Outcome|Placebo|identical buffer
432167|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
432168|NCT00919113|O2|Outcome|Placebo|identical buffer
432169|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
432170|NCT00919113|E2|Reported Event|Placebo|"identical buffer~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
432171|NCT00919113|E1|Reported Event|Uracyst|"2% sodium chondroitin sulfate~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
432172|NCT00919061|B1|Baseline|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
432173|NCT00919061|P1|Participant Flow|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
432174|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
432175|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
432176|NCT00919061|E1|Reported Event|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
432177|NCT00919035|B1|Baseline|Torisel|"Single Agent Temsorilmus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
432178|NCT00919035|P1|Participant Flow|Torisel|"Single Agent Temsirolimus (Torisel®)~torisel: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
432179|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
432180|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
432181|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
432182|NCT00919035|E1|Reported Event|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
432183|NCT00918957|B3|Baseline|Total|Total of all reporting groups
432184|NCT00918957|B2|Baseline|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432185|NCT00918957|B1|Baseline|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432186|NCT00918957|P2|Participant Flow|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432187|NCT00918957|P1|Participant Flow|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432188|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432189|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432190|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432191|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432192|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432193|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432194|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432195|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432196|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432197|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432198|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432199|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432200|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432201|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432202|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432203|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432204|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432205|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432206|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432207|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432208|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432209|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432210|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432211|NCT00918957|E2|Reported Event|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
432212|NCT00918957|E1|Reported Event|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
432213|NCT00918931|B1|Baseline|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
432214|NCT00918931|P1|Participant Flow|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
432215|NCT00918931|O1|Outcome|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
432216|NCT00918931|E1|Reported Event|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
432217|NCT00918879|B3|Baseline|Total|Total of all reporting groups
432218|NCT00918879|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
432219|NCT00918879|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
432220|NCT00918879|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
432221|NCT00918879|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
432222|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
432223|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
432224|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
432225|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
432226|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
432227|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
432228|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
432229|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
432230|NCT00918879|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
432231|NCT00918879|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
432232|NCT00918866|B3|Baseline|Total|Total of all reporting groups
432233|NCT00918866|B2|Baseline|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432234|NCT00918866|B1|Baseline|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432235|NCT00918866|P2|Participant Flow|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432236|NCT00918866|P1|Participant Flow|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432237|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432238|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432239|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432240|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432241|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432242|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432243|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432244|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432245|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432246|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432247|NCT00918866|E2|Reported Event|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
432248|NCT00918866|E1|Reported Event|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
432249|NCT00918749|B4|Baseline|Total|Total of all reporting groups
432250|NCT00918749|B3|Baseline|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432251|NCT00918749|B2|Baseline|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432252|NCT00918749|B1|Baseline|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432253|NCT00918749|P3|Participant Flow|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432254|NCT00918749|P2|Participant Flow|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432255|NCT00918749|P1|Participant Flow|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432256|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432257|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432258|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432259|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432260|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432261|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432262|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432263|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432264|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432265|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432266|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432267|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432268|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432269|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432270|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432271|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432272|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432273|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432274|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432275|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432276|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432277|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432278|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432279|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432280|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432281|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432282|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432283|NCT00918749|E3|Reported Event|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432284|NCT00918749|E2|Reported Event|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
432285|NCT00918749|E1|Reported Event|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
432286|NCT00918736|B1|Baseline|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
432287|NCT00918736|P1|Participant Flow|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
432288|NCT00918736|O1|Outcome|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
432289|NCT00918736|E1|Reported Event|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
432290|NCT00918723|B1|Baseline|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432291|NCT00918723|P1|Participant Flow|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432292|NCT00918723|O1|Outcome|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432317|NCT00918580|P1|Participant Flow|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432318|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432419|NCT00918255|E3|Reported Event|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432293|NCT00918723|O1|Outcome|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432294|NCT00918723|O1|Outcome|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432295|NCT00918723|O1|Outcome|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432296|NCT00918723|O2|Outcome|MTD for Vorinostat During Maintenance Therapy|"MTD for patients who started Rituximab + Vorinostat Maintenance Therapy. Maintenance therapy: Following 4-6 cycles of FCR plus vorinostat, maintenance Rituximab + Vorinostat will be given every 3 months (+/- two weeks) for 2 years. Vorinostat is given PO on days 1-14 of cycles.~Rituximab: Given IV~Vorinostat: Given PO"
432297|NCT00918723|O1|Outcome|MTD for Vorinostat During Induction Therapy|"MTD for patients who started induction therapy with FCR + vorinostat. Induction therapy: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432298|NCT00918723|E1|Reported Event|Treatment (Induction and Maintenance Chemotherapy)|"INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.~Fludarabine Phosphate: Given IV~Cyclophosphamide: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
432299|NCT00918684|B1|Baseline|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
432300|NCT00918684|P1|Participant Flow|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
432301|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
432302|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
432303|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
432304|NCT00918684|E1|Reported Event|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
432305|NCT00918671|B1|Baseline|Medication-overuse Headache|Chronic daily headache combined with medication overuse
432306|NCT00918671|P1|Participant Flow|Medication-overuse Headache|Chronic daily headache combined with medication overuse
432307|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
432308|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
432309|NCT00918671|E1|Reported Event|Medication-overuse Headache|Chronic daily headache combined with medication overuse
432310|NCT00918645|B1|Baseline|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
432311|NCT00918645|P1|Participant Flow|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
432312|NCT00918645|O1|Outcome|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
432313|NCT00918645|O1|Outcome|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
432314|NCT00918645|O1|Outcome|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
432315|NCT00918645|E1|Reported Event|41 Ca|41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
432316|NCT00918580|B1|Baseline|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432418|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432319|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432320|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432321|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432322|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432323|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432324|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432325|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432326|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432327|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432328|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432329|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
432330|NCT00918580|E4|Reported Event|1-Year Follow-up|Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2.
432331|NCT00918580|E3|Reported Event|6-Month Follow-up|Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact.
432332|NCT00918580|E2|Reported Event|13vPnC Dose 2|Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw.
432333|NCT00918580|E1|Reported Event|13vPnC Dose 1|Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2.
432334|NCT00918385|B3|Baseline|Total|Total of all reporting groups
432335|NCT00918385|B2|Baseline|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
432336|NCT00918385|B1|Baseline|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
432337|NCT00918385|P2|Participant Flow|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
432338|NCT00918385|P1|Participant Flow|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
432339|NCT00918385|O1|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
432340|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
432341|NCT00918385|O2|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
432342|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
432343|NCT00918385|E3|Reported Event|Combination Nilutamide and Dasatinib|
432344|NCT00918385|E2|Reported Event|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
432345|NCT00918385|E1|Reported Event|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
432346|NCT00918346|B1|Baseline|Entire Study Population|Includes all 43 randomized patients (86 eyes)
432347|NCT00918346|P2|Participant Flow|Unpreserved Formulation First, Then Preserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks, then preserved formulation (after washout)
432348|NCT00918346|P1|Participant Flow|Preserved Formulation First, Then Unpreserved Formulation|Tafluprost 0.0015% preserved formulation once daily for first 4 weeks, then unpreserved formulation (after washout)
432349|NCT00918346|O1|Outcome|RM ANCOVA: PP Efficacy Dataset|randomized patients who completed the study per protocol (PP)
432350|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized who received at least one dose of study medication and had at least one IOP measurement
432351|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
432352|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
432353|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
432354|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
432355|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
432356|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
432357|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
432358|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
432359|NCT00918346|E2|Reported Event|Unpreserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks
432360|NCT00918346|E1|Reported Event|Preserved Formulation|Tafluprost 0.0015% preserved formulation once daily for 4 weeks
432361|NCT00918333|B3|Baseline|Total|Total of all reporting groups
432362|NCT00918333|B2|Baseline|Phase II (Panobinostat + Everolimus)|Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432363|NCT00918333|B1|Baseline|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432364|NCT00918333|P2|Participant Flow|Phase II (Panobinostat + Everolimus)|Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432365|NCT00918333|P1|Participant Flow|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432366|NCT00918333|O3|Outcome|Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)|Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432367|NCT00918333|O2|Outcome|Phase II (Myeloma Patients Receiving 20 mg LBH589)|Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432368|NCT00918333|O1|Outcome|Phase II (Lymphoma Patients Receiving 20 mg LBL589)|Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432369|NCT00918333|O4|Outcome|Phase II (Myeloma Patients Receiving 30/40 mg LBH589)|Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432370|NCT00918333|O3|Outcome|Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)|Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432371|NCT00918333|O2|Outcome|Phase II (Myeloma Patients Receiving 20 mg LBH589)|Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432372|NCT00918333|O1|Outcome|Phase II (Lymphoma Patients Receiving 20 mg LBL589)|Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432373|NCT00918333|O4|Outcome|Phase II (Myeloma Patients Receiving 30/40 mg LBH589)|Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432374|NCT00918333|O3|Outcome|Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)|Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432375|NCT00918333|O2|Outcome|Phase II (Myeloma Patients Receiving 20 mg LBH589)|Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432376|NCT00918333|O1|Outcome|Phase II (Lymphoma Patients Receiving 20 mg LBL589)|Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432377|NCT00918333|O4|Outcome|Phase II (Myeloma Patients Receiving 30/40 mg LBH589)|Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432378|NCT00918333|O3|Outcome|Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)|Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432379|NCT00918333|O2|Outcome|Phase II (Myeloma Patients Receiving 20 mg LBH589)|Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432380|NCT00918333|O1|Outcome|Phase II (Lymphoma Patients Receiving 20 mg LBL589)|Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432381|NCT00918333|O1|Outcome|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432382|NCT00918333|E2|Reported Event|Phase II (Panobinostat + Everolimus)|Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432383|NCT00918333|E1|Reported Event|Phase I (Panobinostat + Everolimus)|Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
432384|NCT00918281|B1|Baseline|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
432385|NCT00918281|P1|Participant Flow|1 Fluciclatide Injection|AH111585 (18F) Injection : AH111585 (18F) Injection
432386|NCT00918281|O1|Outcome|Number of Adverse Events|The number of adverse events in relationship to the categories descrbed using Fluciclatide Injection (AH111585 (18F) Injection).
432387|NCT00918281|O3|Outcome|Relative Difference|The Relative difference between imaging sessions 1 and 2.
432388|NCT00918281|O2|Outcome|Imaging Session 2|Fluciclatide Injection (AH111585 (18F) Injection)
432389|NCT00918281|O1|Outcome|Imaging Session 1|Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi [370 megabecquerels (MBq)]
432390|NCT00918281|E1|Reported Event|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
432391|NCT00918255|B4|Baseline|Total|Total of all reporting groups
432392|NCT00918255|B3|Baseline|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432393|NCT00918255|B2|Baseline|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432394|NCT00918255|B1|Baseline|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432395|NCT00918255|P3|Participant Flow|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432396|NCT00918255|P2|Participant Flow|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432397|NCT00918255|P1|Participant Flow|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432398|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432399|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432400|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432401|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432402|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432403|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432404|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432405|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432406|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432407|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432408|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432409|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432410|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432411|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432412|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432413|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432414|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432415|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432416|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
432417|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432420|NCT00918255|E2|Reported Event|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
432421|NCT00918255|E1|Reported Event|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
432422|NCT00918203|B3|Baseline|Total|Total of all reporting groups
432423|NCT00918203|B2|Baseline|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432424|NCT00918203|B1|Baseline|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432425|NCT00918203|P3|Participant Flow|Crossover to Olaratumab Monotherapy|Olaratumab was administered IV at 15 mg/kg on Day 1 and Day 8 every 3 weeks.
432426|NCT00918203|P2|Participant Flow|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432427|NCT00918203|P1|Participant Flow|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle~Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants who experience progressive disease may cross over to olaratumab monotherapy.~Paclitaxel: 200 mg/m2 is then administered intravenously (IV) over 3 hours~carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432428|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432429|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432430|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25 mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432431|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432432|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432433|NCT00918203|O2|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
432434|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432435|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432436|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432460|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
432461|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
432462|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
432437|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432438|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
432439|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432440|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432441|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432442|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432443|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
432444|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432445|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432446|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
432447|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432448|NCT00918203|O1|Outcome|Olaratumab + Pacilitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432449|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
432450|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432451|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of Olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432452|NCT00918203|E3|Reported Event|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
432453|NCT00918203|E2|Reported Event|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432454|NCT00918203|E1|Reported Event|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of IMC-3G3 on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
432455|NCT00918138|B3|Baseline|Total|Total of all reporting groups
432456|NCT00918138|B2|Baseline|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
432457|NCT00918138|B1|Baseline|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
432458|NCT00918138|P2|Participant Flow|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
432459|NCT00918138|P1|Participant Flow|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
438935|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
432463|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
432464|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
432465|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
432466|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
432467|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
432468|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
432469|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
432470|NCT00918138|E2|Reported Event|Saxagliptin 5 mg + Metformin XR 1500 mg|Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo
432471|NCT00918138|E1|Reported Event|Metformin 2000 mg|Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo
432472|NCT00918125|B3|Baseline|Total|Total of all reporting groups
432473|NCT00918125|B2|Baseline|White Patients|Patients who self-identified as White
432474|NCT00918125|B1|Baseline|Black Patients|Patients who self-identified as African American
432475|NCT00918125|P2|Participant Flow|Video Intervention|Patients in this arm viewed an educational video on sudden cardiac arrest and ICDs.
432476|NCT00918125|P1|Participant Flow|Standard of Care|Patients in this arm received standard of care (counseling from a physician).
432477|NCT00918125|O2|Outcome|Whites|All Whites in study
432478|NCT00918125|O1|Outcome|African Americans|All African Americans in study
432479|NCT00918125|O2|Outcome|Whites|Whites in study from all study arms
432480|NCT00918125|O1|Outcome|African Americans|African Americans in study from all study arms
432481|NCT00918125|O2|Outcome|Standard of Care|Usual care
432482|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
432483|NCT00918125|O2|Outcome|Standard of Care|Usual care
432484|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
432485|NCT00918125|E1|Reported Event|All Patients|Patients in this arm received standard of care (counseling from a physician).
432486|NCT00917865|B1|Baseline|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
432487|NCT00917865|P1|Participant Flow|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
432488|NCT00917865|O4|Outcome|Mean SUV Maxat 40minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 40 minutes
432489|NCT00917865|O3|Outcome|Mean SUV Max at 28 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 28 minutes
432490|NCT00917865|O2|Outcome|Mean SUV Maxat 16 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 16 minutes
432491|NCT00917865|O1|Outcome|Mean SUV Max at 4 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 4 minutes
432492|NCT00917865|O4|Outcome|Diagnostic Performance Per Sextant 40minutes Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative"
432493|NCT00917865|O3|Outcome|Diagnostic Performance Per Sextant 28mins Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative"
432494|NCT00917865|O2|Outcome|Diagnostic Performance Per sextant16mins Post Injetion|"At this time point, the 120 sextants analysed were categorized as followed:~68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative"
432495|NCT00917865|O1|Outcome|Diagnostic Performance Per Sextant at 4mins Post Injection|Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point.
432496|NCT00917865|E1|Reported Event|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
432497|NCT00917852|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|
432498|NCT00917852|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|
432499|NCT00917852|O1|Outcome|GORE Conformable TAG® Thoracic Endoprosthesis|Gore Conformable TAG Thoracic Endoprosthesis: Endovascular stent graft
432500|NCT00917852|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|
432501|NCT00917852|E1|Reported Event|CTAG Device Trauma Subjects|
432502|NCT00917735|B3|Baseline|Total|Total of all reporting groups
432503|NCT00917735|B2|Baseline|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year
432504|NCT00917735|B1|Baseline|Green Tea Extract|Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year
432505|NCT00917735|P2|Participant Flow|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
432506|NCT00917735|P1|Participant Flow|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).
432507|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
432541|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
432508|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
432509|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
432510|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
432511|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
432512|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
432513|NCT00917735|E2|Reported Event|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
432514|NCT00917735|E1|Reported Event|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
432515|NCT00917644|B1|Baseline|Total Study Population|New 80 milligram (mg) atorvastatin tablets (test); marketed 80 mg atorvastatin commercial tablet (Lipitor®) (reference)
432516|NCT00917644|P2|Participant Flow|Reference Drug First|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period and new (test) 80 mg atorvastatin tablets as a single dose in the second intervention period (after washout period).
432517|NCT00917644|P1|Participant Flow|Test Drug First|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period and marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the second intervention period (after washout period).
432518|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
432519|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
432520|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
432521|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
432522|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
432523|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
432524|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
432525|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
432526|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
432527|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
432528|NCT00917644|E2|Reported Event|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
432529|NCT00917644|E1|Reported Event|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
432530|NCT00917579|B1|Baseline|Total Number of Participants|All participants received atorvastatin 10 mg tablets (new and marketed).
432531|NCT00917579|P2|Participant Flow|Reference Drug First, Then Test Drug|Marketed (reference) 10 mg atorvastatin commercial tablet (Lipitor®) as a single oral dose in the first intervention period, and new (test) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
432532|NCT00917579|P1|Participant Flow|Test Drug First, Then Reference Drug|New (test) 10 milligram (mg) atorvastatin tablet as a single oral dose in the first intervention period, and marketed (reference) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
432533|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
432534|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
432535|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
432536|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
432537|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
432538|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
432539|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
432540|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
432542|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
432543|NCT00917579|E2|Reported Event|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single dose.
432544|NCT00917579|E1|Reported Event|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose.
432545|NCT00917501|B3|Baseline|Total|Total of all reporting groups
432546|NCT00917501|B2|Baseline|Omega-3|Fish oil - 3 capsules/day
432547|NCT00917501|B1|Baseline|Placebo|Olive oil - 3 capsules/day
432548|NCT00917501|P2|Participant Flow|Omega-3|Fish oil - 3 capsules/day
432549|NCT00917501|P1|Participant Flow|Placebo|Olive oil - 3 capsules/day
432550|NCT00917501|O2|Outcome|Omega-3|Fish oil - 3 capsules/day
432551|NCT00917501|O1|Outcome|Placebo|Olive oil - 3 capsules/day
432552|NCT00917501|E2|Reported Event|Omega-3|Fish oil - 3 capsules/day
432553|NCT00917501|E1|Reported Event|Placebo|Olive oil - 3 capsules/day
432554|NCT00917384|B3|Baseline|Total|Total of all reporting groups
432555|NCT00917384|B2|Baseline|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432556|NCT00917384|B1|Baseline|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432557|NCT00917384|P2|Participant Flow|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432558|NCT00917384|P1|Participant Flow|IMC-1121B (Ramucirumab )|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432559|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432560|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432561|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432562|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432563|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432564|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432565|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432566|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432588|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432589|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432567|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432568|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432569|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432570|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432571|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432572|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432573|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432574|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432575|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432576|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432577|NCT00917384|E2|Reported Event|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432578|NCT00917384|E1|Reported Event|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
432579|NCT00917267|B3|Baseline|Total|Total of all reporting groups
432580|NCT00917267|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432581|NCT00917267|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432582|NCT00917267|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432583|NCT00917267|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432584|NCT00917267|O4|Outcome|Exenatide Twice Daily Without SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening
432585|NCT00917267|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening
432586|NCT00917267|O2|Outcome|Exenatide Twice Daily With SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and with SU use at Screening
432587|NCT00917267|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and with SU use at Screening
432590|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432591|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432592|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432593|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432594|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432595|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432596|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432597|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432598|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432599|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432600|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432601|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432602|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432603|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432604|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432605|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432606|NCT00917267|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
432607|NCT00917267|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
432608|NCT00917124|B3|Baseline|Total|Total of all reporting groups
432609|NCT00917124|B2|Baseline|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
432610|NCT00917124|B1|Baseline|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
432611|NCT00917124|P2|Participant Flow|INVOS|INVOS (In Vivo optical Spectroscopy): Monitoring cerebral oxygenation (rSO2) with INVOS device. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
432612|NCT00917124|P1|Participant Flow|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
432613|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
432614|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
432615|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
432616|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
432617|NCT00917124|E2|Reported Event|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
432618|NCT00917124|E1|Reported Event|INVOS|INVOS : Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
432619|NCT00916929|B3|Baseline|Total|Total of all reporting groups
432620|NCT00916929|B2|Baseline|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
432621|NCT00916929|B1|Baseline|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
432622|NCT00916929|P2|Participant Flow|Cardiac Resynchronization Therapy (CRT-D) Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
432623|NCT00916929|P1|Participant Flow|Implantable Cardioverter Defibrillator (ICD) Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
432624|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
432625|NCT00916929|O1|Outcome|Cardiac Resynchronizaiton Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
432626|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
432627|NCT00916929|O1|Outcome|Cardiac Resynchronization Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
432628|NCT00916929|E2|Reported Event|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
432629|NCT00916929|E1|Reported Event|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil
432630|NCT00916721|B3|Baseline|Total|Total of all reporting groups
432631|NCT00916721|B2|Baseline|Placebo|
432632|NCT00916721|B1|Baseline|Propranolol|
432633|NCT00916721|P2|Participant Flow|Placebo|A single oral dose of identical placebo capsule in a double-blind fashion
432634|NCT00916721|P1|Participant Flow|Propranolol|A single oral dose of propranolol or identical placebo capsule in a double-blind fashion. Propranolol dose was 0.67 mg/kg of the short-acting formulation, rounded to the nearest 10 mg, with a minimum dose of 40 mg and a maximum dose of 80 mg
432635|NCT00916721|O2|Outcome|Placebo|
432636|NCT00916721|O1|Outcome|Propranolol|
432637|NCT00916721|O2|Outcome|Placebo|
432638|NCT00916721|O1|Outcome|Propranolol|
432639|NCT00916721|O2|Outcome|Placebo|
432640|NCT00916721|O1|Outcome|Propranolol|
432641|NCT00916721|O2|Outcome|Placebo|
432642|NCT00916721|O1|Outcome|Propranolol|
432643|NCT00916721|E2|Reported Event|Placebo|
432644|NCT00916721|E1|Reported Event|Propranolol|
432645|NCT00916643|B1|Baseline|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
432646|NCT00916643|P1|Participant Flow|H.E.L.P. Secura|"All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.~H.E.L.P. is a device composed of multiple modules and associated disposables to selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient.~Flush system with normal saline;~Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;~Mix plasma with equal volume of acetate buffer containing heparin;~Precipitate LDL as a complex with heparin;~Remove LDL-heparin precipitate by continuous circulation through a filter;~Remove heparin with use of a heparin adsorber;~Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;~Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient."
432647|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
432648|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
432678|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432679|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432680|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432681|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432682|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432683|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432649|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
432650|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
432651|NCT00916643|E1|Reported Event|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
432652|NCT00916617|B5|Baseline|Total|Total of all reporting groups
432653|NCT00916617|B4|Baseline|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432654|NCT00916617|B3|Baseline|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
432655|NCT00916617|B2|Baseline|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432656|NCT00916617|B1|Baseline|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
432657|NCT00916617|P4|Participant Flow|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432658|NCT00916617|P3|Participant Flow|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
432659|NCT00916617|P2|Participant Flow|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432660|NCT00916617|P1|Participant Flow|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
432661|NCT00916617|O4|Outcome|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432662|NCT00916617|O3|Outcome|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
432663|NCT00916617|O2|Outcome|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432664|NCT00916617|O1|Outcome|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
432665|NCT00916617|O4|Outcome|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432666|NCT00916617|O3|Outcome|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
432667|NCT00916617|O2|Outcome|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432668|NCT00916617|O1|Outcome|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
432669|NCT00916617|E4|Reported Event|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432670|NCT00916617|E3|Reported Event|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
432671|NCT00916617|E2|Reported Event|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
432672|NCT00916617|E1|Reported Event|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
432673|NCT00916539|B3|Baseline|Total|Total of all reporting groups
432674|NCT00916539|B2|Baseline|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432675|NCT00916539|B1|Baseline|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432676|NCT00916539|P2|Participant Flow|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432677|NCT00916539|P1|Participant Flow|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432684|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432685|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432686|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432687|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432688|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432689|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432690|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432691|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432692|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432693|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432694|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432695|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432696|NCT00916539|E2|Reported Event|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
432697|NCT00916539|E1|Reported Event|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
432698|NCT00916383|B1|Baseline|All Participants|All patients received the same study treatment, consisting of 1 placebo patch and 1 Donepezil Transdermal Patch, and all patches were applied to the same body locations according to 1 of 6 treatment sequences. The active patch was applied to either the right or the left side of the body according to the randomization schedule. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 body locations (upper arm, upper back, side of torso) for a total treatment period of 21 days.
432699|NCT00916383|P1|Participant Flow|All Participants|"Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.~Upper Back, Upper Arm, Side of Torso~Upper Arm, Side of Torso, Upper Back~Side of Torso, Upper Back, Upper Arm~Upper Back, Side of Torso, Upper Arm~Upper Arm, Upper Back, Side of Torso~Side of Torso, Upper Arm, Upper Back~Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal."
432700|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
432701|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
432702|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
432703|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
432704|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
432705|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
432706|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
432707|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
432708|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
432709|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
432710|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
432711|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
432712|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
432713|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
432714|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
432715|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
432716|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
432717|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
432718|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
432719|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
432720|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
432721|NCT00916383|E3|Reported Event|Placebo Patch|Localized events
432722|NCT00916383|E2|Reported Event|DTP-system|Localized events
432723|NCT00916383|E1|Reported Event|Systemic Events|All enrolled patients
432724|NCT00916370|B3|Baseline|Total|Total of all reporting groups
432725|NCT00916370|B2|Baseline|Long Lesion Registry|Use of long lesion stents.
432726|NCT00916370|B1|Baseline|Core Size Registry|Core size indicates the range of diameters of the stents used.
432727|NCT00916370|P2|Participant Flow|Long Lesion Registry|Use of long lesion stents.
432728|NCT00916370|P1|Participant Flow|Core Size Registry|Core size indicates the range of diameters of the stents used.
432729|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432730|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432731|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432732|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432733|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432734|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
438936|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
432735|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432736|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432737|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432738|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432739|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432740|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432741|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432742|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432743|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432744|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432745|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432746|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432747|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432748|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432749|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432750|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432751|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432752|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432753|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432754|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432755|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432756|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432757|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432758|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432759|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432760|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432761|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432762|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432763|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432764|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432765|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432766|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432767|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432768|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432769|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432770|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432771|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432772|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432773|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432774|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432775|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432776|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432777|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432778|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432779|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432780|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432781|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432782|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432783|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432784|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432785|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432786|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432787|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432788|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432789|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432790|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432791|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432792|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432793|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432794|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432795|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432796|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432797|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432798|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432799|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
438937|NCT00902174|E2|Reported Event|Placebo|Placebo to imatinib
432800|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432801|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432802|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432803|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432804|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432805|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432806|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432807|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432808|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432809|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432810|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432811|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432812|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432813|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432814|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432815|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432816|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432817|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432818|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432819|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432820|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432821|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432822|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432823|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432824|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432825|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432826|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432827|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432828|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432829|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432830|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432831|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432832|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432833|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432834|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432835|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432836|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432837|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432838|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432839|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432840|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432841|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432842|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432843|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432844|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432845|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432846|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432847|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432848|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432849|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432850|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432851|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432852|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432853|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432854|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432855|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432856|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432857|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432858|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432859|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432860|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432861|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432862|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432863|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432864|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432865|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432866|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432867|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432868|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432869|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432870|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432871|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432872|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432873|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432874|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432875|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432876|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432877|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432878|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432879|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432880|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432881|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432882|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432883|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
432884|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432885|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432886|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432887|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432888|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432889|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432890|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432891|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432892|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432893|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432894|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432895|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432896|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432897|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
432898|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
432899|NCT00916370|E2|Reported Event|Long Lesion Registry|Use of long lesion stents.
432900|NCT00916370|E1|Reported Event|Core Size Registry|Core size indicates the range of diameters of the stents used.
432901|NCT00916357|B1|Baseline|Overall Study|Participants who received at least 1 dose of Humalog, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during dose-finding (DV) visits or experimental (data gathering) visits.
432902|NCT00916357|P6|Participant Flow|Humulin-R + rHuPH20, Then Humalog + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog alone following a 3- to 14-day washout period.
432903|NCT00916357|P5|Participant Flow|Humulin-R + rHuPH20, Then Humalog, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3-to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
432904|NCT00916357|P4|Participant Flow|Humalog + rHuPH20, Then Humulin-R + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog following a 3- to 14-day washout period.
432905|NCT00916357|P3|Participant Flow|Humalog + rHuPH20, Then Humalog, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period
432935|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432906|NCT00916357|P2|Participant Flow|Humalog, Then Humulin-R + rHuPH20, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
432907|NCT00916357|P1|Participant Flow|Humalog, Then Humalog + rHuPH20, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with up to 0.3- to 0.5-U/kg Humalog + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
432908|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432909|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432910|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432911|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432912|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432913|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432914|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432915|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432916|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432917|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432918|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432919|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432920|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432921|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432922|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432923|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432924|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432925|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432926|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432927|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432928|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432929|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432930|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432931|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432932|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432933|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432934|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
434674|NCT00912028|P1|Participant Flow|Senofilcon A|"contact lens~senofilcon A: contact lens"
432936|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432937|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432938|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432939|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
432940|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
432941|NCT00916357|E3|Reported Event|Humulin-R + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20 during Periods 1, 2, or 3 of the Study
432942|NCT00916357|E2|Reported Event|Humalog + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20 during Periods 1, 2, or 3 of the study.
432943|NCT00916357|E1|Reported Event|Humalog Alone|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog during Periods 1, 2, or 3 of the study.
432944|NCT00916344|B1|Baseline|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
432945|NCT00916344|P1|Participant Flow|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
432946|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
432947|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
432948|NCT00916344|E1|Reported Event|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
432949|NCT00916305|B3|Baseline|Total|Total of all reporting groups
432950|NCT00916305|B2|Baseline|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
432951|NCT00916305|B1|Baseline|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
432952|NCT00916305|P2|Participant Flow|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
432953|NCT00916305|P1|Participant Flow|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
432954|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
432955|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
432956|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
432957|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
432958|NCT00916305|E2|Reported Event|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
432959|NCT00916305|E1|Reported Event|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
432960|NCT00916279|B1|Baseline|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
432961|NCT00916279|P1|Participant Flow|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
432962|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
432963|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
432964|NCT00916279|O1|Outcome|Lutonix PTCA Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
432965|NCT00916279|O1|Outcome|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
432966|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
432967|NCT00916279|E1|Reported Event|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
432968|NCT00916136|B3|Baseline|Total|Total of all reporting groups
432969|NCT00916136|B2|Baseline|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
432970|NCT00916136|B1|Baseline|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
432971|NCT00916136|P2|Participant Flow|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
432972|NCT00916136|P1|Participant Flow|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
432973|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
432974|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
432975|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
432976|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
432977|NCT00916136|E2|Reported Event|Skeletal Traction|"A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
432978|NCT00916136|E1|Reported Event|Cutaneous Traction|"Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
432979|NCT00916032|B1|Baseline|All Study Participants|Participants were randomized to receive via intravenous infusion 3000 International Units (IU) Advate using either one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence.
432980|NCT00916032|P2|Participant Flow|One 3000 IU Vial Then Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432981|NCT00916032|P1|Participant Flow|Two 1500 IU Vials Then One 3000 IU Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by one 3000 IU potency vial dissolved in 5 mL diluent.
432982|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432983|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
432984|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432985|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
432986|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432987|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
432988|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432989|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
432990|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432991|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
432992|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432993|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
432994|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432995|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433034|NCT00915902|P2|Participant Flow|Placebo Then Lovaza|Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks
432996|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432997|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
432998|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
432999|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433000|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433001|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433002|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433003|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433004|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433005|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433006|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433007|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433008|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433009|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433010|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433011|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433012|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433013|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433014|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433015|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433016|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
433017|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
433018|NCT00916032|E2|Reported Event|Two 1500 IU Vials|
433019|NCT00916032|E1|Reported Event|One 3000 International Unit (IU) Vial|
433020|NCT00916006|B3|Baseline|Total|Total of all reporting groups
433021|NCT00916006|B2|Baseline|Vehicle|Vehicle gel once daily for 3 consecutive days
433022|NCT00916006|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433023|NCT00916006|P2|Participant Flow|Vehicle|Vehicle gel once daily for 3 consecutive days
433024|NCT00916006|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433025|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
433026|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433027|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
433028|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433029|NCT00916006|E2|Reported Event|Vehicle|Vehicle gel once daily for 3 consecutive days
433030|NCT00916006|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433031|NCT00915902|B3|Baseline|Total|Total of all reporting groups
433032|NCT00915902|B2|Baseline|Placebo Followed by Treatment (Lovaza)|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
433033|NCT00915902|B1|Baseline|Treatment (Lovaza) Followed by Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks
434675|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
433035|NCT00915902|P1|Participant Flow|Lovaza Then Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks
433036|NCT00915902|O2|Outcome|Placebo|Placebo: Placebo, two 1-gram capsules taken twice daily for 8 weeks
433037|NCT00915902|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Omega-3-acid ethyl esters: Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
433038|NCT00915902|E4|Reported Event|Placebo Followed by Treatment (Lovaza), During Treatment|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout.
433039|NCT00915902|E3|Reported Event|Placebo Followed by Treatment (Lovaza), During Placebo|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout.
433040|NCT00915902|E2|Reported Event|Treatment (Lovaza) Followed by Placebo, During Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout.
433041|NCT00915902|E1|Reported Event|Treatment (Lovaza) Followed by Placebo, During Treatment|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo.
433042|NCT00915876|B3|Baseline|Total|Total of all reporting groups
433043|NCT00915876|B2|Baseline|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
433044|NCT00915876|B1|Baseline|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
433045|NCT00915876|P2|Participant Flow|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
433046|NCT00915876|P1|Participant Flow|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
433047|NCT00915876|O2|Outcome|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
433048|NCT00915876|O1|Outcome|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
433049|NCT00915876|E2|Reported Event|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
433050|NCT00915876|E1|Reported Event|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
433051|NCT00915798|B5|Baseline|Total|Total of all reporting groups
433052|NCT00915798|B4|Baseline|Control Nonsmokers|Control nonsmokers participated in the abstinence condition.
433053|NCT00915798|B3|Baseline|Control Smokers|Control smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
433054|NCT00915798|B2|Baseline|ADHD Nonsmokers|ADHD nonsmokers participated in the abstinence condition.
433055|NCT00915798|B1|Baseline|ADHD Smokers|ADHD smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
433056|NCT00915798|P4|Participant Flow|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
433057|NCT00915798|P3|Participant Flow|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
433058|NCT00915798|P2|Participant Flow|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
433059|NCT00915798|P1|Participant Flow|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
433060|NCT00915798|O4|Outcome|Control Nonsmokers|
433061|NCT00915798|O3|Outcome|Control Smokers|
433062|NCT00915798|O2|Outcome|ADHD Nonsmokers|
433063|NCT00915798|O1|Outcome|ADHD Smokers|
433064|NCT00915798|O4|Outcome|Control Nonsmokers|Control nonsmokers provided a blood sample.
433065|NCT00915798|O3|Outcome|Control Smokers|Control smokers provided a blood sample.
433066|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers with ADHD provided a blood sample.
433067|NCT00915798|O1|Outcome|Smokers With ADHD|Smokers with ADHD provided a blood sample.
433068|NCT00915798|O6|Outcome|Control Smokers After Smoking|Control smokers after smoking the first cigarette of the day
433069|NCT00915798|O5|Outcome|Smokers With ADHD After Smoking|Smokers with ADHD after smoking the first cigarette of the day
433070|NCT00915798|O4|Outcome|Control Nonsmokers|Nonsmokers participate in one condition.
433071|NCT00915798|O3|Outcome|Control Smokers After Abstinence|Control smokers after overnight abstinence (withdrawal).
433072|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers participate in one condition.
433073|NCT00915798|O1|Outcome|Smokers With ADHD After Abstinence|Smokers with ADHD after overnight abstinence (withdrawal).
433074|NCT00915798|E4|Reported Event|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
433075|NCT00915798|E3|Reported Event|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each participant will undergo an fMRI scan during an experimental task consisting of mathematical problems and unpleasant and neutral pictures. Smokers will undergo two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
433076|NCT00915798|E2|Reported Event|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
433139|NCT00915655|P1|Participant Flow|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
438938|NCT00902174|E1|Reported Event|Imatinib|imatinib mesylate
433077|NCT00915798|E1|Reported Event|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
433078|NCT00915772|B4|Baseline|Total|Total of all reporting groups
433079|NCT00915772|B3|Baseline|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433080|NCT00915772|B2|Baseline|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433081|NCT00915772|B1|Baseline|M1000|Metformin 1000mg monotherapy twice daily
433082|NCT00915772|P3|Participant Flow|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433083|NCT00915772|P2|Participant Flow|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433084|NCT00915772|P1|Participant Flow|M1000|Metformin 1000mg monotherapy twice daily
433085|NCT00915772|O4|Outcome|Post-treat|7 days follow-up period
433086|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433087|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433088|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433089|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433090|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433091|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433092|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433093|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433094|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433095|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433096|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433097|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433098|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433099|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433100|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433101|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433102|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433103|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433104|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433105|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433106|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433107|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433108|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433109|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433110|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433111|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433112|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433113|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433114|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433115|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433116|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433117|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433118|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433119|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433120|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433121|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433122|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
433123|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
433124|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
433125|NCT00915772|E3|Reported Event|L2.5+M1000|Linagliptin 2.5 mg + Metformin 1000 mg twice daily
433126|NCT00915772|E2|Reported Event|L2.5+M500|Linagliptin 2.5 mg + Metformin 500 mg twice daily
433127|NCT00915772|E1|Reported Event|M1000|Metformin 1000 mg twice daily
433128|NCT00915759|B1|Baseline|ProKera and Bandage Contact Lens|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
433129|NCT00915759|P1|Participant Flow|ProKera/Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
433130|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 3: bandage contact lens in place until postoperative day 1
433131|NCT00915759|O1|Outcome|ProKera|Group 3: ProKera in place until postoperative day 1
433132|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 2: bandage contact lens in place until postoperative day 3
433133|NCT00915759|O1|Outcome|ProKera|Group 2: ProKera in place until postoperative day 3
433134|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 1: bandage contact lens in place until complete corneal re-repithelialization (healing)
433135|NCT00915759|O1|Outcome|ProKera|Group 1: ProKera in place until complete corneal re-repithelialization (healing)
433136|NCT00915759|E2|Reported Event|Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
433137|NCT00915759|E1|Reported Event|ProKera|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
433138|NCT00915655|B1|Baseline|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
433140|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
433141|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
433142|NCT00915655|E1|Reported Event|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
433143|NCT00915603|B3|Baseline|Total|Total of all reporting groups
433144|NCT00915603|B2|Baseline|Paclitaxel/Carboplatin/Everolimus|
433145|NCT00915603|B1|Baseline|Paclitaxel/Carboplatin/Placebo|
433146|NCT00915603|P2|Participant Flow|Paclitaxel/Carboplatin/Everolimus|
433147|NCT00915603|P1|Participant Flow|Paclitaxel/Carboplatin/Placebo|
433148|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
433149|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
433150|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
433151|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
433152|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
433153|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
433154|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
433155|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
433156|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
433157|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
433158|NCT00915603|E2|Reported Event|Paclitaxel/Bevacizumab/Placebo|
433159|NCT00915603|E1|Reported Event|Paclitaxel/Bevacizumab/Everolimus|
433160|NCT00915590|B3|Baseline|Total|Total of all reporting groups
433161|NCT00915590|B2|Baseline|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433162|NCT00915590|B1|Baseline|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433163|NCT00915590|P2|Participant Flow|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433164|NCT00915590|P1|Participant Flow|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433165|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433166|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433167|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433168|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433169|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433170|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433171|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433172|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433173|NCT00915590|O2|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks~IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
433174|NCT00915590|O1|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks~IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
434676|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
433175|NCT00915590|O2|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433176|NCT00915590|O1|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
433177|NCT00915590|E3|Reported Event|Off Treatment|Off treatment
433178|NCT00915590|E2|Reported Event|IL-1Ra|IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
433179|NCT00915590|E1|Reported Event|Placebo|Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks
433180|NCT00915551|B3|Baseline|Total|Total of all reporting groups
433181|NCT00915551|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
433182|NCT00915551|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433183|NCT00915551|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
433184|NCT00915551|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433185|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
433186|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
433187|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
433188|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
433189|NCT00915551|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
433190|NCT00915551|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
433191|NCT00915525|B3|Baseline|Total|Total of all reporting groups
433192|NCT00915525|B2|Baseline|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433193|NCT00915525|B1|Baseline|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433194|NCT00915525|P2|Participant Flow|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433195|NCT00915525|P1|Participant Flow|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433196|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433197|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433198|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433199|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433200|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433201|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433202|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433203|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433204|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433205|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433206|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433207|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433208|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433209|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433210|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433211|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433212|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433213|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433214|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433215|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433216|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433217|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433218|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433219|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433220|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433221|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433222|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433223|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433224|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433225|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433226|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433227|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433228|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433229|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433230|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433231|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433232|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433233|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433234|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433235|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433236|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433237|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433238|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433239|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433240|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433241|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433242|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433243|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433244|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433245|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433246|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433247|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
434677|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
433248|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433249|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433250|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433251|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433252|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433253|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433254|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433255|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433256|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433257|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433258|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433259|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433260|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433261|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433262|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433263|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433264|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433265|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433266|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433267|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433268|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433269|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433270|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433271|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433272|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433273|NCT00915525|E22|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 13|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433274|NCT00915525|E21|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 12|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433275|NCT00915525|E20|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 11|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433276|NCT00915525|E19|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 10|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433277|NCT00915525|E18|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 10|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433278|NCT00915525|E17|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 9|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433279|NCT00915525|E16|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 9|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433280|NCT00915525|E15|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 8|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433974|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433281|NCT00915525|E14|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 8|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433282|NCT00915525|E13|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 7|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433283|NCT00915525|E12|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 7|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433284|NCT00915525|E11|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 6|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433285|NCT00915525|E10|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 6|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433286|NCT00915525|E9|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 5|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433287|NCT00915525|E8|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 5|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433288|NCT00915525|E7|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 4|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433289|NCT00915525|E6|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 4|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433290|NCT00915525|E5|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 3|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433291|NCT00915525|E4|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 3|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433292|NCT00915525|E3|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 2|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433293|NCT00915525|E2|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 2|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433294|NCT00915525|E1|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 1|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
433295|NCT00915499|B3|Baseline|Total|Total of all reporting groups
433296|NCT00915499|B2|Baseline|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
433297|NCT00915499|B1|Baseline|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
433298|NCT00915499|P2|Participant Flow|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
433299|NCT00915499|P1|Participant Flow|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
433300|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
433301|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
433302|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
433303|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
433304|NCT00915499|E2|Reported Event|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
433305|NCT00915499|E1|Reported Event|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
433306|NCT00915473|B3|Baseline|Total|Total of all reporting groups
433307|NCT00915473|B2|Baseline|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433308|NCT00915473|B1|Baseline|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433309|NCT00915473|P2|Participant Flow|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433310|NCT00915473|P1|Participant Flow|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433311|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433312|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433313|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433314|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433315|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433404|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
433316|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433317|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433318|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
433319|NCT00915473|E2|Reported Event|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.
433320|NCT00915473|E1|Reported Event|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
433321|NCT00915356|B6|Baseline|Total|Total of all reporting groups
433322|NCT00915356|B5|Baseline|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433323|NCT00915356|B4|Baseline|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433324|NCT00915356|B3|Baseline|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433325|NCT00915356|B2|Baseline|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433326|NCT00915356|B1|Baseline|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433327|NCT00915356|P5|Participant Flow|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433328|NCT00915356|P4|Participant Flow|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433329|NCT00915356|P3|Participant Flow|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433330|NCT00915356|P2|Participant Flow|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433331|NCT00915356|P1|Participant Flow|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433332|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433333|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433334|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433335|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433336|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433337|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433338|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433339|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433340|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433341|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433342|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433343|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433344|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433345|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
438939|NCT00902161|B3|Baseline|Total|Total of all reporting groups
433346|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433347|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433348|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433349|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433350|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433351|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433352|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433353|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433354|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433355|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433356|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433357|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433358|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433359|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433360|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433361|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433362|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433363|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433364|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433365|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433366|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433367|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433368|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433369|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433370|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433371|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433372|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433373|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433374|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433405|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433375|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433376|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433377|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433378|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433379|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433380|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433381|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433382|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433383|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433384|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433385|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433386|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433387|NCT00915356|E5|Reported Event|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
433388|NCT00915356|E4|Reported Event|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
433389|NCT00915356|E3|Reported Event|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
433390|NCT00915356|E2|Reported Event|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
433391|NCT00915356|E1|Reported Event|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
433392|NCT00915343|B1|Baseline|Entire Study|Included all participants randomized to receive hydrocortisone MR tablets orally OD first or hydrocortisone tablets orally TID first; in any of the intervention periods during the 12-week cross-over period of Part A or hydrocortisone MR tablets orally OD during the 6-month open-label period of Part B.
433393|NCT00915343|P3|Participant Flow|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD for 6 months.
433394|NCT00915343|P2|Participant Flow|Hydrocortisone TID Then Hydrocortisone MR OD - Part A|Participants received hydrocortisone tablets TID in the first intervention period then novel OD hydrocortisone MR tablets in the second intervention period, at the same total daily dose of 20 to 40 mg for 12 weeks.
433395|NCT00915343|P1|Participant Flow|Hydrocortisone MR OD Then Hydrocortisone TID - Part A|Participants received novel once daily (OD) hydrocortisone modified release (MR) tablets in the first intervention period then hydrocortisone tablets thrice daily (TID) in the second intervention period, at the same total daily dose of 20 to 40 milligram (mg) for 12 weeks.
433396|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433397|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433398|NCT00915343|O1|Outcome|Hydrocortisone OD Versus TID|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study. Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433399|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
433400|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433401|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433402|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
433403|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|During the 4-week run-in period prior to the first intervention period during Part A, participants on a twice-a-day (BID) regimen were transferred to a thrice-a-day (TID) regimen while maintaining the same total daily hydrocortisone dose. In the first and second intervention periods during Part A, participants were randomised to novel once daily (OD) treatment with hydrocortisone modified release (MR) tablets 20 to 40 milligram (mg) orally and the treatment continued for 12 weeks and returned every 4 weeks for study drug dispensation.
434088|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
433406|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433407|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
433408|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433409|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433410|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
433411|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433412|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433413|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
433414|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433415|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433416|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433417|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433418|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433419|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433420|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433421|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433422|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433423|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433424|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433425|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433426|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433427|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433428|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433429|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433430|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433431|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433432|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433433|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433434|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433435|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433436|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433437|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433438|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433439|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433440|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433441|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433442|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433443|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433444|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433445|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433446|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433447|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433448|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433449|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433450|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433451|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433452|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
434089|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
433453|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433454|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433455|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433456|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433457|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433458|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433459|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433460|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433461|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433462|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433463|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433464|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433465|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433466|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
433467|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
433468|NCT00915343|E5|Reported Event|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the entire 6-month period of Part B.
433469|NCT00915343|E4|Reported Event|Hydrocortisone MR Tablet OD - Part B (Second 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the second 3 months of Part B (6 months).
433470|NCT00915343|E3|Reported Event|Hydrocortisone MR Tablet OD - Part B (First 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the first 3 months of Part B (6 months).
433471|NCT00915343|E2|Reported Event|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally, thrice daily (TID) during the 12-week period of Part A.
433472|NCT00915343|E1|Reported Event|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone modified release (MR) tablets 20 to 40 mg orally, once daily (OD) during the 12-week period of Part A.
433473|NCT00915278|B7|Baseline|Total|Total of all reporting groups
433474|NCT00915278|B6|Baseline|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433475|NCT00915278|B5|Baseline|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433476|NCT00915278|B4|Baseline|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433477|NCT00915278|B3|Baseline|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433478|NCT00915278|B2|Baseline|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433479|NCT00915278|B1|Baseline|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433480|NCT00915278|P6|Participant Flow|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433481|NCT00915278|P5|Participant Flow|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433482|NCT00915278|P4|Participant Flow|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433483|NCT00915278|P3|Participant Flow|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433484|NCT00915278|P2|Participant Flow|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433485|NCT00915278|P1|Participant Flow|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433668|NCT00914927|B4|Baseline|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
440392|NCT00895622|B3|Baseline|High Risk|60 Gy radiotherapy
433486|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433487|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433488|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433489|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433490|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433491|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433492|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433493|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433494|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433495|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433496|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433497|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433498|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433499|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433500|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433501|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433502|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433503|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433504|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433505|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433506|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433507|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433508|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
440393|NCT00895622|B2|Baseline|Intermidiate Risk|54 Gy radiotherapy
433509|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433510|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433511|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433512|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433513|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433514|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433515|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433516|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433517|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433518|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433519|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433520|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433521|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433522|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433523|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433524|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433525|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433526|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433527|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433528|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433529|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433530|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433531|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
440394|NCT00895622|B1|Baseline|Low Risk|No treatment given
433532|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433533|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433534|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433535|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433536|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433537|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433538|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433539|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433540|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433541|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433542|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433543|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433544|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433545|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433546|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433547|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433548|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433549|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433550|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433551|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433552|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433553|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433554|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
440395|NCT00895622|P3|Participant Flow|High Risk|60 Gy radiotherapy
433555|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433556|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433557|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433558|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433559|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433560|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433561|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433562|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433563|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433564|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433565|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433566|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433567|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433568|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433569|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433570|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433571|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433572|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433573|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433574|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433575|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433576|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433577|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
440404|NCT00895622|O3|Outcome|High Risk|60 Gy radiotherapy
433578|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433579|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433580|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433581|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433582|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433583|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433584|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433585|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433586|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433587|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433588|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433589|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433590|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433591|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433592|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433593|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433594|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433595|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433596|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433597|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433598|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433599|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433600|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
440405|NCT00895622|O2|Outcome|Intermidiate Risk|54 Gy radiotherapy
433601|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433602|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433603|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433604|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433605|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433606|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433607|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433608|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433609|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433610|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433611|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433612|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433613|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433614|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433615|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433616|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433617|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433618|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433619|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433620|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433621|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433622|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433623|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
440406|NCT00895622|O1|Outcome|Low Risk|No treatment given
433624|NCT00915278|E6|Reported Event|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433625|NCT00915278|E5|Reported Event|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433626|NCT00915278|E4|Reported Event|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433627|NCT00915278|E3|Reported Event|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433628|NCT00915278|E2|Reported Event|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433629|NCT00915278|E1|Reported Event|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
433630|NCT00915148|B1|Baseline|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
433631|NCT00915148|P1|Participant Flow|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
433632|NCT00915148|O1|Outcome|Women Delivered Within 6 Hours|"Nulliparous women, single pregnancy, > 37 weeks of pregnancy, fetus alive and cephalic presentation.~Ultrasound examinations: 2D transperineal scan"
433633|NCT00915148|O1|Outcome|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
433634|NCT00915148|E1|Reported Event|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
433635|NCT00915018|B3|Baseline|Total|Total of all reporting groups
433636|NCT00915018|B2|Baseline|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433637|NCT00915018|B1|Baseline|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433638|NCT00915018|P2|Participant Flow|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433639|NCT00915018|P1|Participant Flow|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433640|NCT00915018|O2|Outcome|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433641|NCT00915018|O1|Outcome|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433642|NCT00915018|O2|Outcome|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433669|NCT00914927|B3|Baseline|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
434678|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
433643|NCT00915018|O1|Outcome|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433644|NCT00915018|O2|Outcome|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433645|NCT00915018|O1|Outcome|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433646|NCT00915018|O2|Outcome|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433647|NCT00915018|O1|Outcome|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433648|NCT00915018|O2|Outcome|Trastuzumab + Paclitaxel|"Trastuzumab + Paclitaxel~Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433649|NCT00915018|O1|Outcome|Neratinib + Paclitaxel|"Neratinib + Paclitaxel~Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.~Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent."
433650|NCT00915018|E2|Reported Event|Trastuzumab+Paclitaxel|Trastuzumab + Paclitaxel
433651|NCT00915018|E1|Reported Event|Neratinib+Paclitaxel|Neratinib + Paclitaxel
433652|NCT00914966|B1|Baseline|CINRYZE|"There were 3 potential dose escalation steps:~Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)~Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks~Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
433653|NCT00914966|P1|Participant Flow|CINRYZE|"There were 3 potential dose escalation steps:~Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)~Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks~Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
433654|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
433655|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
433656|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
433657|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
433658|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
433659|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
433660|NCT00914966|E4|Reported Event|All Subjects|
433661|NCT00914966|E3|Reported Event|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
433662|NCT00914966|E2|Reported Event|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
433663|NCT00914966|E1|Reported Event|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
433664|NCT00914927|B8|Baseline|Total|Total of all reporting groups
433665|NCT00914927|B7|Baseline|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433666|NCT00914927|B6|Baseline|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433667|NCT00914927|B5|Baseline|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
440407|NCT00895622|O2|Outcome|High Risk|60 Gy radiotherapy
433670|NCT00914927|B2|Baseline|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433671|NCT00914927|B1|Baseline|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433672|NCT00914927|P7|Participant Flow|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433673|NCT00914927|P6|Participant Flow|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433674|NCT00914927|P5|Participant Flow|Cohort B: 0 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
433675|NCT00914927|P4|Participant Flow|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433676|NCT00914927|P3|Participant Flow|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433677|NCT00914927|P2|Participant Flow|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433678|NCT00914927|P1|Participant Flow|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433679|NCT00914927|O7|Outcome|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433680|NCT00914927|O6|Outcome|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433681|NCT00914927|O5|Outcome|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
433682|NCT00914927|O4|Outcome|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433683|NCT00914927|O3|Outcome|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433684|NCT00914927|O2|Outcome|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433685|NCT00914927|O1|Outcome|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433686|NCT00914927|O7|Outcome|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433687|NCT00914927|O6|Outcome|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433688|NCT00914927|O5|Outcome|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
433689|NCT00914927|O4|Outcome|Cohort A: Placebo, IG Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433690|NCT00914927|O3|Outcome|Cohort A: 80 mg Avatrombopag, IG Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433691|NCT00914927|O2|Outcome|Cohort A: 40 mg Avatrombopag, IG Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433692|NCT00914927|O1|Outcome|Cohort A: 20 mg Avatrombopag, IG Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433693|NCT00914927|O7|Outcome|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433694|NCT00914927|O6|Outcome|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433695|NCT00914927|O5|Outcome|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
433696|NCT00914927|O4|Outcome|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433697|NCT00914927|O3|Outcome|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433698|NCT00914927|O2|Outcome|Cohort A:40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
434679|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
433699|NCT00914927|O1|Outcome|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433700|NCT00914927|O7|Outcome|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433701|NCT00914927|O6|Outcome|Cohort B: 20 mg Aavatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433702|NCT00914927|O5|Outcome|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
433703|NCT00914927|O4|Outcome|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433704|NCT00914927|O3|Outcome|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433705|NCT00914927|O2|Outcome|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433706|NCT00914927|O1|Outcome|Cohort A: 20 mg Aavatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433707|NCT00914927|O7|Outcome|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433708|NCT00914927|O6|Outcome|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433709|NCT00914927|O5|Outcome|Cohort B:10 mg Avatrombopag, 2G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433710|NCT00914927|O4|Outcome|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433711|NCT00914927|O3|Outcome|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433712|NCT00914927|O2|Outcome|Cohort A: 40 mg Avatrombopag , 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433713|NCT00914927|O1|Outcome|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433714|NCT00914927|E7|Reported Event|Cohort B: Placebo, 2G Formulation|Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433715|NCT00914927|E6|Reported Event|Cohort B: 20 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
433716|NCT00914927|E5|Reported Event|Cohort B: 10 mg Avatrombopag, 2G Formulation|Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
433717|NCT00914927|E4|Reported Event|Cohort A: Placebo, 1G Formulation|Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
433718|NCT00914927|E3|Reported Event|Cohort A: 80 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433719|NCT00914927|E2|Reported Event|Cohort A: 40 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433720|NCT00914927|E1|Reported Event|Cohort A: 20 mg Avatrombopag, 1G Formulation|Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
433721|NCT00914862|B6|Baseline|Total|Total of all reporting groups
433722|NCT00914862|B5|Baseline|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433723|NCT00914862|B4|Baseline|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433724|NCT00914862|B3|Baseline|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433725|NCT00914862|B2|Baseline|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433726|NCT00914862|B1|Baseline|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433727|NCT00914862|P5|Participant Flow|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433728|NCT00914862|P4|Participant Flow|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433729|NCT00914862|P3|Participant Flow|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433730|NCT00914862|P2|Participant Flow|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433731|NCT00914862|P1|Participant Flow|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) received a single 4 mg oral dose of ramelteon.
440408|NCT00895622|O1|Outcome|Intermidiate Risk|54 Gy radiotherapy
433732|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433733|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433734|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433735|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433736|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433737|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433738|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433739|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433740|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433741|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433742|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433743|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433744|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433745|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433746|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433747|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433748|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433749|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433750|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433751|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433752|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433753|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433754|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433755|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433756|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433757|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433758|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433759|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433760|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433761|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433762|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433763|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433764|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433765|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433766|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433767|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433768|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433769|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433770|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433771|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433772|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433773|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433774|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433775|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433776|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433777|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433778|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433779|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433780|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433781|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433782|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433783|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433784|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433785|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433786|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433787|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433788|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433789|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433790|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433791|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433792|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433793|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433794|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433795|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433796|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433797|NCT00914862|E5|Reported Event|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
433798|NCT00914862|E4|Reported Event|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
433799|NCT00914862|E3|Reported Event|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
433800|NCT00914862|E2|Reported Event|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
433801|NCT00914862|E1|Reported Event|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
433802|NCT00914849|B3|Baseline|Total|Total of all reporting groups
433803|NCT00914849|B2|Baseline|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433804|NCT00914849|B1|Baseline|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433805|NCT00914849|P2|Participant Flow|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433806|NCT00914849|P1|Participant Flow|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg intravenous (IV)~Leukopheresis~Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433807|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433808|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433809|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433810|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433834|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
434352|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
433811|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433812|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433813|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433814|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433815|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433816|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433817|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433818|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433819|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433820|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433821|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433822|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433823|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433824|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433825|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433826|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433827|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433828|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433829|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433830|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433831|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433832|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433833|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433835|NCT00914849|E2|Reported Event|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
433836|NCT00914849|E1|Reported Event|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
433837|NCT00914810|B3|Baseline|Total|Total of all reporting groups
433838|NCT00914810|B2|Baseline|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
433839|NCT00914810|B1|Baseline|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
433840|NCT00914810|P2|Participant Flow|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
433841|NCT00914810|P1|Participant Flow|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
433842|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
433843|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
433844|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
433845|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
433846|NCT00914810|E2|Reported Event|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
433847|NCT00914810|E1|Reported Event|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
433848|NCT00914589|B4|Baseline|Total|Total of all reporting groups
433849|NCT00914589|B3|Baseline|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433850|NCT00914589|B2|Baseline|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433851|NCT00914589|B1|Baseline|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433852|NCT00914589|P3|Participant Flow|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433853|NCT00914589|P2|Participant Flow|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433854|NCT00914589|P1|Participant Flow|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433855|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433856|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433857|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433858|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433859|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433860|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433861|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433862|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433863|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433864|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433865|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433866|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433867|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433868|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433869|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433870|NCT00914589|E3|Reported Event|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433871|NCT00914589|E2|Reported Event|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
433872|NCT00914589|E1|Reported Event|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
433873|NCT00914485|B1|Baseline|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
433874|NCT00914485|P1|Participant Flow|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
434680|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
433875|NCT00914485|O1|Outcome|Arm 1|"Provider clinical communication training intervention~Provider Communication Skills Training: Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
433876|NCT00914485|E1|Reported Event|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
433877|NCT00914459|B3|Baseline|Total|Total of all reporting groups
433878|NCT00914459|B2|Baseline|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433879|NCT00914459|B1|Baseline|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433880|NCT00914459|P2|Participant Flow|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433881|NCT00914459|P1|Participant Flow|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 international units per kilogram [IU/kg] up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the Summary of Product Characteristics (SmPC).
433882|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433883|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433884|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433885|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433886|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433887|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433888|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433889|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433890|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433891|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433892|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433893|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433894|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433895|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433896|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433897|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433973|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
434681|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
433898|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged less than or equal to [<=] 12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433899|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433900|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433901|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433902|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433903|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433904|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433905|NCT00914459|E1|Reported Event|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
433906|NCT00914316|B5|Baseline|Total|Total of all reporting groups
433907|NCT00914316|B4|Baseline|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
433908|NCT00914316|B3|Baseline|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433909|NCT00914316|B2|Baseline|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433910|NCT00914316|B1|Baseline|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
433911|NCT00914316|P4|Participant Flow|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
433912|NCT00914316|P3|Participant Flow|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433913|NCT00914316|P2|Participant Flow|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433914|NCT00914316|P1|Participant Flow|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
433915|NCT00914316|O4|Outcome|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
433916|NCT00914316|O3|Outcome|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433917|NCT00914316|O2|Outcome|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433918|NCT00914316|O1|Outcome|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
433919|NCT00914316|O4|Outcome|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
433920|NCT00914316|O3|Outcome|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433921|NCT00914316|O2|Outcome|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433922|NCT00914316|O1|Outcome|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
433923|NCT00914316|E4|Reported Event|Phase 1 -Placebo, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Placebo: twice daily"
433924|NCT00914316|E3|Reported Event|Phase 1 -Placebo, Phase 2 -Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433925|NCT00914316|E2|Reported Event|Phase 1 -Ranolazine, Phase 2 -Placebo|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth.~Placebo: twice daily"
433926|NCT00914316|E1|Reported Event|Phase 1-Ranolazine, Phase 2-Ranolazine|"This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.~Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth."
433927|NCT00914186|B5|Baseline|Total|Total of all reporting groups
433928|NCT00914186|B4|Baseline|TS-022 0.020%|lotion/once daily
433929|NCT00914186|B3|Baseline|TS-022 0.010%|lotion/once daily
433930|NCT00914186|B2|Baseline|TS-022 0.005%|lotion/once daily
433931|NCT00914186|B1|Baseline|Vehicle|once daily
433932|NCT00914186|P4|Participant Flow|TS-022 0.020%|lotion/once daily
433933|NCT00914186|P3|Participant Flow|TS-022 0.010%|lotion/once daily
433934|NCT00914186|P2|Participant Flow|TS-022 0.005%|lotion/once daily
433935|NCT00914186|P1|Participant Flow|Vehicle|once daily
433936|NCT00914186|O2|Outcome|TS-022|lotion/once daily
433937|NCT00914186|O1|Outcome|Vehicle|once daily
433938|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
433939|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
433940|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
433941|NCT00914186|O1|Outcome|Vehicle|once daily
433942|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
433943|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
433944|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
433945|NCT00914186|O1|Outcome|Vehicle|once daily
433946|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
433947|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
433948|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
433949|NCT00914186|O1|Outcome|Vehicle|once daily
433950|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
433951|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
433952|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
433953|NCT00914186|O1|Outcome|Vehicle|once daily
433954|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
433955|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
433956|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
433957|NCT00914186|O1|Outcome|Vehicle|once daily
433958|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
433959|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
433960|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
433961|NCT00914186|O1|Outcome|Vehicle|once daily
433962|NCT00914186|E4|Reported Event|TS-022 0.020%|lotion/once daily
433963|NCT00914186|E3|Reported Event|TS-022 0.010%|lotion/once daily
433964|NCT00914186|E2|Reported Event|TS-022 0.005%|lotion/once daily
433965|NCT00914186|E1|Reported Event|Vehicle|once daily
433966|NCT00914069|B3|Baseline|Total|Total of all reporting groups
433967|NCT00914069|B2|Baseline|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
433968|NCT00914069|B1|Baseline|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433969|NCT00914069|P2|Participant Flow|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
433970|NCT00914069|P1|Participant Flow|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433971|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
433972|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433975|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
433976|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433977|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
433978|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433979|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
433980|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433981|NCT00914069|E2|Reported Event|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
433982|NCT00914069|E1|Reported Event|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
433983|NCT00913913|B1|Baseline|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
433984|NCT00913913|P1|Participant Flow|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
433985|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
433986|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
433987|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
433988|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
433989|NCT00913913|E1|Reported Event|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
433990|NCT00913835|B3|Baseline|Total|Total of all reporting groups
433991|NCT00913835|B2|Baseline|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
433992|NCT00913835|B1|Baseline|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
433993|NCT00913835|P2|Participant Flow|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
433994|NCT00913835|P1|Participant Flow|Olaratumab + Liposomal Doxorubicin|"20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.~40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434082|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
433995|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
433996|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
433997|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Treatment|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
433998|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
433999|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434000|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434001|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434002|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434003|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434004|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434005|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434006|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434007|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434008|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434009|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434010|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434011|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434083|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434084|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434012|NCT00913835|O1|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434013|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434014|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434015|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434016|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy.."
434017|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434018|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434019|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434020|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434021|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434022|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434023|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434024|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434025|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434026|NCT00913835|E3|Reported Event|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
434027|NCT00913835|E2|Reported Event|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
434028|NCT00913835|E1|Reported Event|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
434029|NCT00913770|B4|Baseline|Total|Total of all reporting groups
434085|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434030|NCT00913770|B3|Baseline|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
434031|NCT00913770|B2|Baseline|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
434032|NCT00913770|B1|Baseline|Standard Care|Standard Care including receiving a referral.
434033|NCT00913770|P3|Participant Flow|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
434034|NCT00913770|P2|Participant Flow|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
434035|NCT00913770|P1|Participant Flow|Standard Care|Standard Care including receiving a referral.
434036|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
434037|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
434038|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
434039|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
434040|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
434041|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
434042|NCT00913770|E3|Reported Event|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
434086|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434087|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434043|NCT00913770|E2|Reported Event|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
434044|NCT00913770|E1|Reported Event|Standard Care|Standard Care including receiving a referral.
434045|NCT00913744|B3|Baseline|Total|Total of all reporting groups
434046|NCT00913744|B2|Baseline|Sham|Sham injection
434047|NCT00913744|B1|Baseline|Ocriplasmin|Intravitreal injection (125 µg)
434048|NCT00913744|P2|Participant Flow|Sham|Sham injection
434049|NCT00913744|P1|Participant Flow|Ocriplasmin|Intravitreal injection (125 µg)
434050|NCT00913744|O2|Outcome|Sham|Sham injection
434051|NCT00913744|O1|Outcome|Ocriplasmin|Intravitreal injection (125 µg)
434052|NCT00913744|E2|Reported Event|Sham|Sham injection
434053|NCT00913744|E1|Reported Event|Ocriplasmin|Intravitreal injection (125 µg)
434054|NCT00913692|B1|Baseline|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
434055|NCT00913692|P1|Participant Flow|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
434056|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
434057|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
434058|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
434059|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
434060|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.
434061|NCT00913692|E3|Reported Event|Treatment Phase 2|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
434062|NCT00913692|E2|Reported Event|Washout|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
434063|NCT00913692|E1|Reported Event|Treatment Phase 1|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
434064|NCT00913627|B5|Baseline|Total|Total of all reporting groups
434065|NCT00913627|B4|Baseline|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434066|NCT00913627|B3|Baseline|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434067|NCT00913627|B2|Baseline|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434068|NCT00913627|B1|Baseline|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434069|NCT00913627|P4|Participant Flow|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434070|NCT00913627|P3|Participant Flow|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434071|NCT00913627|P2|Participant Flow|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434072|NCT00913627|P1|Participant Flow|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434073|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434074|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434075|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434076|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434077|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434078|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434079|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434080|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434081|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434090|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434091|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434092|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434093|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434094|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434095|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434096|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434097|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434098|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434099|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434100|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434101|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434102|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434103|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434104|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434105|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434106|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434107|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434108|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434109|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434110|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434111|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434112|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434113|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434114|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434115|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434116|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434117|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434118|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434119|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434120|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434121|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434122|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434123|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434124|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434125|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434126|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434127|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434128|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434129|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434130|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434131|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434132|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434133|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434134|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434135|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434136|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434137|NCT00913627|O4|Outcome|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434138|NCT00913627|O3|Outcome|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434139|NCT00913627|O2|Outcome|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434140|NCT00913627|O1|Outcome|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434141|NCT00913627|E4|Reported Event|Naproxen|Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery
434142|NCT00913627|E3|Reported Event|Ibuprofen IR/ER (Wet Granulation)|Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
434143|NCT00913627|E2|Reported Event|Ibuprofen IR/ER (Roller Compaction)|Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
434144|NCT00913627|E1|Reported Event|Placebo|Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
434145|NCT00913523|B4|Baseline|Total|Total of all reporting groups
434146|NCT00913523|B3|Baseline|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434147|NCT00913523|B2|Baseline|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434148|NCT00913523|B1|Baseline|Tampon With GML|Regular and Super Tampon with GML added to the cover
434149|NCT00913523|P3|Participant Flow|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434150|NCT00913523|P2|Participant Flow|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434151|NCT00913523|P1|Participant Flow|Tampon With GML|Regular and Super Tampon with GML added to the cover
434152|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434153|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434154|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
434155|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434156|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434157|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
434158|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434159|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434160|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
434161|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434162|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434163|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
434164|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434165|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434166|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
434167|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434168|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434169|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
434170|NCT00913523|E3|Reported Event|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
434171|NCT00913523|E2|Reported Event|Tampon Without GML|Regular and Super Tampon without GML added to the cover
434172|NCT00913523|E1|Reported Event|Tampon With GML|Regular and Super Tampon with GML added to the cover
434173|NCT00913510|B3|Baseline|Total|Total of all reporting groups
434174|NCT00913510|B2|Baseline|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
434175|NCT00913510|B1|Baseline|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
434176|NCT00913510|P2|Participant Flow|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start.
434177|NCT00913510|P1|Participant Flow|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start and start of CIC using LoFric Primo catheters.
434178|NCT00913510|O2|Outcome|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
434179|NCT00913510|O1|Outcome|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
434180|NCT00913510|E2|Reported Event|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
434181|NCT00913510|E1|Reported Event|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
434182|NCT00913458|B1|Baseline|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434183|NCT00913458|P7|Participant Flow|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
434353|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434354|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434184|NCT00913458|P6|Participant Flow|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
434185|NCT00913458|P5|Participant Flow|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
434186|NCT00913458|P4|Participant Flow|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434187|NCT00913458|P3|Participant Flow|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434188|NCT00913458|P2|Participant Flow|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434189|NCT00913458|P1|Participant Flow|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434190|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434191|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434192|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434193|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434355|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434194|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434195|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434196|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434197|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434198|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434199|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434200|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434201|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434356|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434357|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434358|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
440409|NCT00895622|O2|Outcome|High Risk|60 Gy radiotherapy
434202|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434203|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434204|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434205|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434206|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434207|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434208|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434209|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434359|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434360|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
440410|NCT00895622|O1|Outcome|Intermidiate Risk|54 Gy radiotherapy
434210|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434211|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434212|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434213|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434214|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434215|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434216|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434217|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434262|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
440411|NCT00895622|O3|Outcome|High Risk|60 Gy radiotherapy
434218|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434219|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434220|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434221|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434222|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434223|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434224|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434225|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434361|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434362|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434363|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
440412|NCT00895622|O2|Outcome|Intermidiate Risk|54 Gy radiotherapy
434226|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434227|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434228|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434229|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434230|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434231|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434232|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe.All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434233|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434364|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434365|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434682|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
434234|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434235|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434236|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434237|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434238|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434239|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434240|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434241|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434263|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
440413|NCT00895622|O1|Outcome|Low Risk|No treatment given
434242|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434243|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434244|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434245|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434246|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434247|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434248|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434249|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434346|NCT00912964|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434347|NCT00912964|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434348|NCT00912964|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
440414|NCT00895622|E3|Reported Event|High Risk|60 Gy radiotherapy
434250|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434251|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
434252|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434253|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434254|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434255|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434256|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434257|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434258|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434259|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434260|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434261|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434349|NCT00912964|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434264|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434265|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434266|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434267|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434268|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434269|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434270|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434271|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
434272|NCT00913458|E7|Reported Event|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
434273|NCT00913458|E6|Reported Event|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
434274|NCT00913458|E5|Reported Event|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
434275|NCT00913458|E4|Reported Event|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434350|NCT00912964|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434351|NCT00912964|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
440415|NCT00895622|E2|Reported Event|Intermidiate Risk|54 Gy radiotherapy
434276|NCT00913458|E3|Reported Event|MTX + PBO (Phase 2)|"In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.~Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
434277|NCT00913458|E2|Reported Event|E25 + MTX (Phase 2)|"In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
434278|NCT00913458|E1|Reported Event|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
434279|NCT00913380|B3|Baseline|Total|Total of all reporting groups
434280|NCT00913380|B2|Baseline|Standard-dose CT|Aimed to 8 mSv in an average patient
434281|NCT00913380|B1|Baseline|Low-dose CT|Aimed to 2 mSv in an average patient
434282|NCT00913380|P2|Participant Flow|Standard-dose CT|Aimed to 8 mSv in an average patient
434283|NCT00913380|P1|Participant Flow|Low-dose CT|Aimed to 2 mSv in an average patient
434284|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434285|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434286|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434287|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434288|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434289|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434290|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434291|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434292|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434293|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434294|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434295|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434296|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434297|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434298|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434299|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434300|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434301|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434302|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434303|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434304|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
434305|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
434306|NCT00913380|E2|Reported Event|Standard-dose CT|Aimed to 8 mSv in an average patient
434307|NCT00913380|E1|Reported Event|Low-dose CT|Aimed to 2 mSv in an average patient
434308|NCT00913263|B1|Baseline|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
434309|NCT00913263|P1|Participant Flow|Hydroxyflutamide (2-HOF)|Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
434310|NCT00913263|O1|Outcome|Part 1|Patients (24 patients) have been injected with Liproca depot once
434311|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
434312|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
434313|NCT00913263|O1|Outcome|Part I|Patients (24 patients) in Part I have been injected with Liproca Depot once.
434314|NCT00913263|O1|Outcome|Group 1|24 patients (Part I of the study) have been injected with Liproca Depot once.
434315|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
434316|NCT00913263|E1|Reported Event|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
434317|NCT00913133|B1|Baseline|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
434318|NCT00913133|P1|Participant Flow|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
434319|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
434320|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
434321|NCT00913133|E1|Reported Event|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
434322|NCT00913081|B1|Baseline|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 1000 mg, Quercetin 2000 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
434323|NCT00913081|P1|Participant Flow|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 100 mg, Quercetin 200 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and pharmacodymic assessments for 8 hours after Quercetin dosing. Each participant then crossed over to one of the remaining dose group/placebo in a randomized, double blind fashion after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
434324|NCT00913081|O4|Outcome|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434325|NCT00913081|O3|Outcome|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434326|NCT00913081|O2|Outcome|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434327|NCT00913081|O1|Outcome|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434328|NCT00913081|E4|Reported Event|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434329|NCT00913081|E3|Reported Event|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434330|NCT00913081|E2|Reported Event|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434331|NCT00913081|E1|Reported Event|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
434332|NCT00913003|B3|Baseline|Total|Total of all reporting groups
434333|NCT00913003|B2|Baseline|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
434334|NCT00913003|B1|Baseline|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
434335|NCT00913003|P2|Participant Flow|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
434336|NCT00913003|P1|Participant Flow|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
434337|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
434338|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
434339|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
434340|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
434341|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
434342|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
434343|NCT00913003|E2|Reported Event|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
434344|NCT00913003|E1|Reported Event|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
434345|NCT00912964|B4|Baseline|Total|Total of all reporting groups
440416|NCT00895622|E1|Reported Event|Low Risk|No treatment given
434366|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434367|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434368|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434369|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434370|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434371|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434372|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434373|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434374|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434375|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434376|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434377|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434378|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434379|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434380|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434381|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434382|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434383|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434384|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434385|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434386|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434387|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434388|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434389|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434390|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434391|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434392|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434393|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434394|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434395|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434396|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434397|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434398|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434399|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434400|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434401|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434402|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434403|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434404|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434405|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434406|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434407|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434408|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434409|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434410|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434411|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434412|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434413|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434414|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434415|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434416|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434417|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434418|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434419|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434420|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434421|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434422|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434423|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434424|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434425|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434426|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434427|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434428|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434429|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434430|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434431|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434432|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434433|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434434|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434435|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434436|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434437|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434438|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434439|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434440|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434441|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434442|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434443|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434444|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434445|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434446|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434447|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434448|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434449|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434450|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434451|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434452|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434453|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434454|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434455|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434456|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434457|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434458|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434459|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434460|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434461|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434462|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434463|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434464|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434465|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434466|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434467|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434468|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434469|NCT00912964|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
434470|NCT00912964|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
434471|NCT00912964|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
434472|NCT00912925|B3|Baseline|Total|Total of all reporting groups
434473|NCT00912925|B2|Baseline|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434474|NCT00912925|B1|Baseline|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434475|NCT00912925|P2|Participant Flow|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434476|NCT00912925|P1|Participant Flow|Placebo|Patients in the placebo-control group were administered a solution of 100 millimolar (mM) sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434477|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434478|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434479|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434480|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434481|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434482|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434483|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434484|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434485|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434486|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434487|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434488|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434489|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
434490|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
434491|NCT00912925|E2|Reported Event|Aldurazyme***Check Title***|Aldurazyme***Check Description***
434492|NCT00912925|E1|Reported Event|Placebo***Check Title***|Placebo***Check Description***
434493|NCT00912912|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
434494|NCT00912912|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
434495|NCT00912912|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
434496|NCT00912912|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
434497|NCT00912808|B3|Baseline|Total|Total of all reporting groups
434498|NCT00912808|B2|Baseline|Placebo (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)|Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
434499|NCT00912808|B1|Baseline|Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)|Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
434500|NCT00912808|P2|Participant Flow|Placebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)|Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
434554|NCT00912509|O2|Outcome|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434501|NCT00912808|P1|Participant Flow|Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)|Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16
434502|NCT00912808|O2|Outcome|Placebo|Participants who received Placebo tablet (matching Donepezil 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.
434503|NCT00912808|O1|Outcome|Donepezil|Participants who received Donepezil tablet (matching 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.
434504|NCT00912808|O2|Outcome|Placebo|Participants who received Placebo tablet (matching Donepezil) each morning in either the first or last 6 weeks of the study.
434505|NCT00912808|O1|Outcome|Donepezil|Participants who received Donepezil tablet (matching 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.
434506|NCT00912808|E2|Reported Event|Placebo Then Donepezil|Sugar pill 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then 3 weeks washout then Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6
434507|NCT00912808|E1|Reported Event|Donepezil Then Placebo|Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then 3 weeks washout then Sugar pill 5 mg qam weeks 1-3, 10 mg qam weeks 3-6
434508|NCT00912795|B3|Baseline|Total|Total of all reporting groups
434509|NCT00912795|B2|Baseline|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
434510|NCT00912795|B1|Baseline|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
434511|NCT00912795|P2|Participant Flow|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
434512|NCT00912795|P1|Participant Flow|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
434513|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
434514|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
434515|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
434516|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
434517|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
434555|NCT00912509|O1|Outcome|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434556|NCT00912509|E2|Reported Event|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434683|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
434518|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
434519|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
434520|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
434521|NCT00912795|E2|Reported Event|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
434522|NCT00912795|E1|Reported Event|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
434523|NCT00912782|B3|Baseline|Total|Total of all reporting groups
434524|NCT00912782|B2|Baseline|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
434525|NCT00912782|B1|Baseline|Placebo|Placebo one time per week for 3 weeks
434526|NCT00912782|P2|Participant Flow|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
434527|NCT00912782|P1|Participant Flow|Placebo|Placebo one time per week for 3 weeks
434528|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
434529|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
434530|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
434531|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
434532|NCT00912782|E2|Reported Event|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
434533|NCT00912782|E1|Reported Event|Placebo|Placebo one time per week for 3 weeks
434534|NCT00912743|B3|Baseline|Total|Total of all reporting groups
434535|NCT00912743|B2|Baseline|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
434536|NCT00912743|B1|Baseline|MSI-H|MSI-H group receiving olaparib 400mg BID
434537|NCT00912743|P2|Participant Flow|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
434538|NCT00912743|P1|Participant Flow|MSI-H|MSI-H group receiving olaparib 400mg BID
434539|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
434540|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
434541|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
434542|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
434543|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
434544|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
434545|NCT00912743|E2|Reported Event|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
434546|NCT00912743|E1|Reported Event|MSI-H|MSI-H group receiving olaparib 400mg BID
434547|NCT00912509|B3|Baseline|Total|Total of all reporting groups
434548|NCT00912509|B2|Baseline|45 Minute Light Duration|"45 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434549|NCT00912509|B1|Baseline|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434550|NCT00912509|P2|Participant Flow|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434551|NCT00912509|P1|Participant Flow|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434552|NCT00912509|O2|Outcome|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434553|NCT00912509|O1|Outcome|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434636|NCT00912158|P2|Participant Flow|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
434557|NCT00912509|E1|Reported Event|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
434558|NCT00912405|B1|Baseline|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
434559|NCT00912405|P1|Participant Flow|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
434560|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
434561|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
434562|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
434563|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
434564|NCT00912405|E1|Reported Event|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
434565|NCT00912301|B4|Baseline|Total|Total of all reporting groups
434566|NCT00912301|B3|Baseline|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434567|NCT00912301|B2|Baseline|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434568|NCT00912301|B1|Baseline|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434569|NCT00912301|P3|Participant Flow|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434570|NCT00912301|P2|Participant Flow|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434571|NCT00912301|P1|Participant Flow|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434572|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434573|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434574|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434575|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434576|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434577|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434578|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434579|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434580|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434581|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434582|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434583|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434584|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434585|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434586|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434587|NCT00912301|E3|Reported Event|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
434588|NCT00912301|E2|Reported Event|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
434589|NCT00912301|E1|Reported Event|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
434590|NCT00912288|B3|Baseline|Total|Total of all reporting groups
434591|NCT00912288|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434592|NCT00912288|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434593|NCT00912288|P2|Participant Flow|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434594|NCT00912288|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434595|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434596|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434597|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434598|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434599|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434600|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434601|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434602|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434603|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434604|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434605|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434606|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434607|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434608|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434609|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434610|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434611|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434612|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434613|NCT00912288|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
434614|NCT00912288|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
434615|NCT00912223|B1|Baseline|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434616|NCT00912223|P1|Participant Flow|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434617|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434618|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434619|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434620|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434621|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434622|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434623|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434624|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434625|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434626|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434627|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434628|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434629|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434630|NCT00912223|E1|Reported Event|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
434631|NCT00912158|B4|Baseline|Total|Total of all reporting groups
434632|NCT00912158|B3|Baseline|Standard Treatment|Standard medical therapy alone
434633|NCT00912158|B2|Baseline|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
434634|NCT00912158|B1|Baseline|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
434635|NCT00912158|P3|Participant Flow|Standard Treatment|Standard medical therapy alone
434637|NCT00912158|P1|Participant Flow|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
434638|NCT00912158|O3|Outcome|Standard Treatment|Standard medical therapy alone
434639|NCT00912158|O2|Outcome|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
434640|NCT00912158|O1|Outcome|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
434641|NCT00912093|B6|Baseline|Total|Total of all reporting groups
434642|NCT00912093|B5|Baseline|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant 30 mg in the controlled phase
434643|NCT00912093|B4|Baseline|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434644|NCT00912093|B3|Baseline|Randomized-Icatibant (Blinded Treatment)--Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
434645|NCT00912093|B2|Baseline|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434646|NCT00912093|B1|Baseline|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
434647|NCT00912093|P5|Participant Flow|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase
434648|NCT00912093|P4|Participant Flow|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434649|NCT00912093|P3|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
434650|NCT00912093|P2|Participant Flow|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434651|NCT00912093|P1|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
434652|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434653|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
434654|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434655|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
434656|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434657|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
434658|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434659|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
434660|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
434661|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
434662|NCT00912093|E4|Reported Event|Open Label Extension – Icatibant (Open Label)|Subjects who treated with icatibant 30 mg in the open label extension phase
434663|NCT00912093|E3|Reported Event|Controlled Phase - Icatibant (Open Label)|Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
434664|NCT00912093|E2|Reported Event|Controlled Phase -Placebo (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase
434665|NCT00912093|E1|Reported Event|Controlled Phase - Icatibant (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
434666|NCT00912028|B4|Baseline|Total|Total of all reporting groups
434667|NCT00912028|B3|Baseline|Methafilcon A|"contact lens~methafilcon A: contact lens"
434668|NCT00912028|B2|Baseline|Balafilcon A|"contact lens~balafilcon A: contact lens"
434669|NCT00912028|B1|Baseline|Senofilcon A|"contact lens~senofilcon A: contact lens"
434670|NCT00912028|P5|Participant Flow|Vifilcon A|"contact lens~vifilcon A: contact lens"
434671|NCT00912028|P4|Participant Flow|Methafilcon A|"contact lens~methafilcon A: contact lens"
434672|NCT00912028|P3|Participant Flow|Balafilcon A|"contact lens~balafilcon A: contact lens"
434673|NCT00912028|P2|Participant Flow|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
434684|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
434685|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
434686|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
434687|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
434688|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
434689|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
434690|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
434691|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
434692|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
434693|NCT00912028|E5|Reported Event|Vifilcon A|"contact lens~vifilcon A: contact lens"
434694|NCT00912028|E4|Reported Event|Methafilcon A|"contact lens~methafilcon A: contact lens"
434695|NCT00912028|E3|Reported Event|Balafilcon A|"contact lens~balafilcon A: contact lens"
434696|NCT00912028|E2|Reported Event|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
434697|NCT00912028|E1|Reported Event|Senofilcon A|"contact lens~senofilcon A: contact lens"
434698|NCT00912015|B5|Baseline|Total|Total of all reporting groups
434699|NCT00912015|B4|Baseline|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434700|NCT00912015|B3|Baseline|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434701|NCT00912015|B2|Baseline|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434702|NCT00912015|B1|Baseline|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434703|NCT00912015|P4|Participant Flow|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434704|NCT00912015|P3|Participant Flow|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434705|NCT00912015|P2|Participant Flow|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434706|NCT00912015|P1|Participant Flow|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434707|NCT00912015|O4|Outcome|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434708|NCT00912015|O3|Outcome|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434709|NCT00912015|O2|Outcome|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434710|NCT00912015|O1|Outcome|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434711|NCT00912015|E4|Reported Event|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434712|NCT00912015|E3|Reported Event|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434713|NCT00912015|E2|Reported Event|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434714|NCT00912015|E1|Reported Event|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
434715|NCT00912002|B1|Baseline|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
434716|NCT00912002|P1|Participant Flow|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
434717|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
434718|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
434719|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
434720|NCT00912002|E1|Reported Event|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
434721|NCT00911989|B1|Baseline|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
434722|NCT00911989|P1|Participant Flow|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
434723|NCT00911989|O1|Outcome|Transvaginal Sleeve Gastrectomy|All subjects on whom the surgery was attempted.
434724|NCT00911989|E1|Reported Event|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
434725|NCT00911937|B3|Baseline|Total|Total of all reporting groups
434726|NCT00911937|B2|Baseline|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434727|NCT00911937|B1|Baseline|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434728|NCT00911937|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434729|NCT00911937|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434730|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
435365|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
434731|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434732|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434733|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434734|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434735|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434736|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434737|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434738|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434739|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434740|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434741|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434742|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434743|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434744|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434745|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434746|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434747|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434748|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434749|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434750|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434751|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434752|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434753|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434754|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434755|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434756|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434757|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434758|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434759|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434760|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
440417|NCT00895583|B3|Baseline|Total|Total of all reporting groups
434761|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434762|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434763|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434764|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434765|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434766|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434767|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434768|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434769|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434770|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434771|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434772|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434773|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434774|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434775|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434776|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434777|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434778|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434779|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434780|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434781|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434782|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434783|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434784|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434785|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434786|NCT00911937|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
434787|NCT00911937|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
434788|NCT00911898|B1|Baseline|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
434789|NCT00911898|P1|Participant Flow|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
434790|NCT00911898|O1|Outcome|MM-111|All participants
434791|NCT00911898|E1|Reported Event|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
434792|NCT00911859|B4|Baseline|Total|Total of all reporting groups
434817|NCT00911859|E4|Reported Event|Part 2, Maintenance Period: Siltuximab|Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
434793|NCT00911859|B3|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434794|NCT00911859|B2|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434795|NCT00911859|B1|Baseline|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434796|NCT00911859|P3|Participant Flow|Part 2: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434797|NCT00911859|P2|Participant Flow|Part 2: VMP|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434798|NCT00911859|P1|Participant Flow|Part 1: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434799|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434800|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434801|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434802|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434803|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434804|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434805|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434806|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434807|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434808|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434809|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434810|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434811|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434812|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434813|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434814|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434815|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434816|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434818|NCT00911859|E3|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434819|NCT00911859|E2|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434820|NCT00911859|E1|Reported Event|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
434821|NCT00911820|B3|Baseline|Total|Total of all reporting groups
434822|NCT00911820|B2|Baseline|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434823|NCT00911820|B1|Baseline|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434824|NCT00911820|P2|Participant Flow|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434825|NCT00911820|P1|Participant Flow|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434826|NCT00911820|O2|Outcome|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434827|NCT00911820|O1|Outcome|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434828|NCT00911820|O2|Outcome|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434829|NCT00911820|O1|Outcome|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434830|NCT00911820|O2|Outcome|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434831|NCT00911820|O1|Outcome|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434832|NCT00911820|O2|Outcome|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434833|NCT00911820|O1|Outcome|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434834|NCT00911820|O2|Outcome|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434835|NCT00911820|O1|Outcome|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434836|NCT00911820|E2|Reported Event|Arm B: TPCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
434880|NCT00911742|E1|Reported Event|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434837|NCT00911820|E1|Reported Event|Arm A: PCA|Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
434838|NCT00911807|B4|Baseline|Total|Total of all reporting groups
434839|NCT00911807|B3|Baseline|Donepezil|
434840|NCT00911807|B2|Baseline|Cerebrolysin|
434841|NCT00911807|B1|Baseline|Cerebrolysin + Donepezil|
434842|NCT00911807|P3|Participant Flow|Donepezil|
434843|NCT00911807|P2|Participant Flow|Cerebrolysin|
434844|NCT00911807|P1|Participant Flow|Cerebrolysin + Donepezil|
434845|NCT00911807|O3|Outcome|Donepezil|
434846|NCT00911807|O2|Outcome|Cerebrolysin|
434847|NCT00911807|O1|Outcome|Cerebrolysin + Donepezil|
434848|NCT00911807|E3|Reported Event|Donepezil|
434849|NCT00911807|E2|Reported Event|Cerebrolysin|
434850|NCT00911807|E1|Reported Event|Cerebrolysin + Donepezil|
434851|NCT00911768|B3|Baseline|Total|Total of all reporting groups
434852|NCT00911768|B2|Baseline|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
434853|NCT00911768|B1|Baseline|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
434854|NCT00911768|P2|Participant Flow|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
434855|NCT00911768|P1|Participant Flow|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
434856|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
434857|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
434858|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
434859|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
434860|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
434861|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
434862|NCT00911768|E2|Reported Event|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
434863|NCT00911768|E1|Reported Event|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
434864|NCT00911742|B3|Baseline|Total|Total of all reporting groups
434865|NCT00911742|B2|Baseline|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434866|NCT00911742|B1|Baseline|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434867|NCT00911742|P2|Participant Flow|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434868|NCT00911742|P1|Participant Flow|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434869|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434870|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434871|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434872|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434873|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434874|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434875|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434876|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434877|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434878|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434879|NCT00911742|E2|Reported Event|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
434881|NCT00911625|B3|Baseline|Total|Total of all reporting groups
435201|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
434882|NCT00911625|B2|Baseline|0.25 Units/kg|"Participants randomized to this arm will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.~0.25 units/kg daily insulin: Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
434883|NCT00911625|B1|Baseline|0.5 Units/kg|"Participants randomized to this arm will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.~0.5 units/kg daily insulin: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
434884|NCT00911625|P2|Participant Flow|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434885|NCT00911625|P1|Participant Flow|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434886|NCT00911625|O2|Outcome|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434887|NCT00911625|O1|Outcome|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434888|NCT00911625|O2|Outcome|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434889|NCT00911625|O1|Outcome|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434890|NCT00911625|E2|Reported Event|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434891|NCT00911625|E1|Reported Event|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
434892|NCT00911612|B3|Baseline|Total|Total of all reporting groups
434893|NCT00911612|B2|Baseline|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434894|NCT00911612|B1|Baseline|Colesevelam|Participants received colesevelam 1.875 g twice daily
434895|NCT00911612|P2|Participant Flow|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434896|NCT00911612|P1|Participant Flow|Colesevelam|Participants received colesevelam 1.875 g twice daily
434897|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434898|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
434899|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434900|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
434901|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434902|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
434903|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434904|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
434905|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434906|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
434907|NCT00911612|E2|Reported Event|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
434908|NCT00911612|E1|Reported Event|Colesevelam|Participants received colesevelam 1.875 g twice daily
434909|NCT00911547|B5|Baseline|Total|Total of all reporting groups
434910|NCT00911547|B4|Baseline|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434911|NCT00911547|B3|Baseline|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434912|NCT00911547|B2|Baseline|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434913|NCT00911547|B1|Baseline|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434914|NCT00911547|P4|Participant Flow|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434915|NCT00911547|P3|Participant Flow|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434973|NCT00911443|P3|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434916|NCT00911547|P2|Participant Flow|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434917|NCT00911547|P1|Participant Flow|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434918|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434919|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434920|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434921|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434922|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434923|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434924|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434925|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434926|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434927|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434928|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434929|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434930|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434931|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434932|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434933|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434934|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434935|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434936|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
435031|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
434937|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434938|NCT00911547|E4|Reported Event|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434939|NCT00911547|E3|Reported Event|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
434940|NCT00911547|E2|Reported Event|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434941|NCT00911547|E1|Reported Event|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
434942|NCT00911534|B3|Baseline|Total|Total of all reporting groups
434943|NCT00911534|B2|Baseline|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
434944|NCT00911534|B1|Baseline|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
434945|NCT00911534|P2|Participant Flow|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
434946|NCT00911534|P1|Participant Flow|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
434947|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
434948|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
434949|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
434950|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
434951|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
434952|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
434953|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
434954|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
434955|NCT00911534|E2|Reported Event|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
434956|NCT00911534|E1|Reported Event|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
434957|NCT00911495|B1|Baseline|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434958|NCT00911495|P1|Participant Flow|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434959|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434960|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434961|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434962|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434963|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434964|NCT00911495|E1|Reported Event|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
434965|NCT00911443|B6|Baseline|Total|Total of all reporting groups
434966|NCT00911443|B5|Baseline|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434967|NCT00911443|B4|Baseline|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434968|NCT00911443|B3|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434969|NCT00911443|B2|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434970|NCT00911443|B1|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434971|NCT00911443|P5|Participant Flow|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434972|NCT00911443|P4|Participant Flow|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434974|NCT00911443|P2|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434975|NCT00911443|P1|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434976|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434977|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434978|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434979|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434980|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434981|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434982|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434983|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434984|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434985|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434986|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434987|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434988|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434989|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434990|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
434991|NCT00911326|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
434992|NCT00911326|P1|Participant Flow|Lymphoseek|Intraoral and cutaneous (head and neck) squamous cell carcinoma (T1-T4, N0, M0) patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m for sentinel lymph node biopsy and elective neck dissection of cervical lymph nodes.
434993|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
434994|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
434995|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
434996|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
434997|NCT00911326|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
434998|NCT00911300|B3|Baseline|Total|Total of all reporting groups
435032|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
435033|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
435034|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
435035|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
434999|NCT00911300|B2|Baseline|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435000|NCT00911300|B1|Baseline|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435001|NCT00911300|P2|Participant Flow|Unfractioned Heparin (UFH)/Vitamin K Antagonist (VKA)|Both CN and CP participants received an initial intravenous (i.v.) bolus injection of 70 international units (IU)/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/hour (h) (at least 1250 IU per hour). The infusion dose was adjusted to maintain an activated partial thromboplastin time (aPTT) at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target international normalized ratio (INR) of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435002|NCT00911300|P1|Participant Flow|Fondaparinux|For clot-negative (CN) participants (par.), 7.5 milligrams (mg) fondaparinux was injected once daily (OD) subcutaneously (for par. with body weight [BW] 50-100 kilograms [kg]); for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For clot-positive (CP) par. with creatinine clearance (CrCl) >= 50 milliliters (mL)/minute (min), 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435003|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435004|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435005|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435006|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435007|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435008|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435009|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435010|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435011|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435012|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435013|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435014|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435015|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435016|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435036|NCT00911170|B3|Baseline|Total|Total of all reporting groups
435366|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435017|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435018|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435019|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435020|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435021|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435022|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435023|NCT00911300|E2|Reported Event|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
435024|NCT00911300|E1|Reported Event|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
435025|NCT00911274|B3|Baseline|Total|Total of all reporting groups
435026|NCT00911274|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
435027|NCT00911274|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
435028|NCT00911274|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
435029|NCT00911274|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
435030|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
435037|NCT00911170|B2|Baseline|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435038|NCT00911170|B1|Baseline|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435039|NCT00911170|P2|Participant Flow|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
435040|NCT00911170|P1|Participant Flow|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
435041|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435042|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435043|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435044|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435045|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435046|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435047|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435048|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435049|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435050|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435051|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435052|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435053|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435054|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435055|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435056|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435057|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435058|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435059|NCT00911170|E2|Reported Event|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435060|NCT00911170|E1|Reported Event|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
435061|NCT00911157|B3|Baseline|Total|Total of all reporting groups
435062|NCT00911157|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
435063|NCT00911157|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435064|NCT00911157|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
435065|NCT00911157|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435066|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
435067|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435068|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
435069|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435070|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
435071|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435072|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
435073|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435074|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
440511|NCT00895453|P3|Participant Flow|Classic Homeopathy|
435075|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435076|NCT00911157|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
435077|NCT00911157|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
435078|NCT00911144|B3|Baseline|Total|Total of all reporting groups
435079|NCT00911144|B2|Baseline|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435080|NCT00911144|B1|Baseline|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435081|NCT00911144|P2|Participant Flow|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435082|NCT00911144|P1|Participant Flow|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435083|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435084|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435085|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435086|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435087|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435088|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435089|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435090|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435091|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435092|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435093|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435094|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435095|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435096|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435129|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
435097|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435098|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435099|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435100|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435101|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435102|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435103|NCT00911144|E2|Reported Event|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435104|NCT00911144|E1|Reported Event|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
435105|NCT00910988|B5|Baseline|Total|Total of all reporting groups
435106|NCT00910988|B4|Baseline|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
435107|NCT00910988|B3|Baseline|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
435108|NCT00910988|B2|Baseline|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
435109|NCT00910988|B1|Baseline|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
435110|NCT00910988|P4|Participant Flow|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
435111|NCT00910988|P3|Participant Flow|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
435112|NCT00910988|P2|Participant Flow|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
435113|NCT00910988|P1|Participant Flow|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
435114|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
435115|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
435116|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
435117|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
435118|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
435119|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
435120|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
435121|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
435122|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
435123|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
435124|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
435125|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
435126|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
435127|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
435128|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
435367|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435130|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
435131|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
435132|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
435133|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
435134|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
435135|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
435136|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
435137|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
435138|NCT00910988|O8|Outcome|Ziprasidone (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
435139|NCT00910988|O7|Outcome|Ziprasidone (Drug/Placebo)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
435140|NCT00910988|O6|Outcome|Ziprasidone (Placebo/Drug)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
435141|NCT00910988|O5|Outcome|Ziprasidone (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
435142|NCT00910988|O4|Outcome|Olanzapine (Placebo/Drug)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
435143|NCT00910988|O3|Outcome|Olanzapine (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
435144|NCT00910988|O2|Outcome|Olanzapine (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
435145|NCT00910988|O1|Outcome|Olanzapine (Drug/Placebo)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
435146|NCT00910988|E8|Reported Event|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
435147|NCT00910988|E7|Reported Event|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
435148|NCT00910988|E6|Reported Event|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
435149|NCT00910988|E5|Reported Event|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
435150|NCT00910988|E4|Reported Event|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
435151|NCT00910988|E3|Reported Event|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
435152|NCT00910988|E2|Reported Event|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
435153|NCT00910988|E1|Reported Event|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
435154|NCT00910962|B4|Baseline|Total|Total of all reporting groups
435155|NCT00910962|B3|Baseline|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435156|NCT00910962|B2|Baseline|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435157|NCT00910962|B1|Baseline|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435158|NCT00910962|P3|Participant Flow|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435159|NCT00910962|P2|Participant Flow|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 milligrams (mg) starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435160|NCT00910962|P1|Participant Flow|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435161|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435162|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435163|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435164|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435165|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435166|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435167|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435168|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435169|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435170|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435171|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435172|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435173|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435174|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435175|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435176|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435177|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435178|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435179|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435180|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435181|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435182|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435183|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435184|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435185|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435186|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435187|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435188|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435189|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435190|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435191|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435192|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435193|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435194|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435195|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435196|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435197|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435198|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435199|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435200|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
440796|NCT00894504|O2|Outcome|EGFR Amplified|
435202|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435203|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435204|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435205|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435206|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435207|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435208|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435209|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435210|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435211|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435212|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435213|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435214|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435215|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435216|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435217|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435218|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435219|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435220|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435221|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435222|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435223|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435224|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435225|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435226|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435227|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435228|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435229|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435230|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435231|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435232|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435233|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435234|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435235|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435236|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
440797|NCT00894504|O1|Outcome|EGFR Normal|
435237|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435238|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435239|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435240|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435241|NCT00910962|O4|Outcome|A and B Combined (C)|A combined data for eligible participants from arm A and arm B were presented.
435242|NCT00910962|O3|Outcome|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435243|NCT00910962|O2|Outcome|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435244|NCT00910962|O1|Outcome|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435245|NCT00910962|E4|Reported Event|A and B Comb (C)|A combined data for eligible participants from arm A and arm B were presented.
435246|NCT00910962|E3|Reported Event|Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B)|Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
435247|NCT00910962|E2|Reported Event|Losmapimod 7.5 mg (A)|Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group).
435248|NCT00910962|E1|Reported Event|Placebo (P)|Eligible participants received matching placebo, orally twice daily for 12 weeks.
435249|NCT00910910|B3|Baseline|Total|Total of all reporting groups
435250|NCT00910910|B2|Baseline|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435251|NCT00910910|B1|Baseline|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435252|NCT00910910|P2|Participant Flow|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435253|NCT00910910|P1|Participant Flow|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435254|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435255|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435256|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435257|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435258|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435287|NCT00910871|P1|Participant Flow|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
435368|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435369|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
440798|NCT00894504|O1|Outcome|Arm/Group 1|
435259|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435260|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435261|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435262|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435263|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435264|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435265|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435266|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435267|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435268|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435269|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435270|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435271|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435272|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435288|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
435370|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435273|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435274|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435275|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435276|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435277|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435278|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435279|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435280|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435281|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435282|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435283|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435284|NCT00910910|E2|Reported Event|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
435285|NCT00910910|E1|Reported Event|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
435286|NCT00910871|B1|Baseline|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
435300|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
435371|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435289|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
435290|NCT00910871|E1|Reported Event|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
435291|NCT00910858|B4|Baseline|Total|Total of all reporting groups
435292|NCT00910858|B3|Baseline|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435293|NCT00910858|B2|Baseline|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435294|NCT00910858|B1|Baseline|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435295|NCT00910858|P3|Participant Flow|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435296|NCT00910858|P2|Participant Flow|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435297|NCT00910858|P1|Participant Flow|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435298|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435299|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435301|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435302|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435303|NCT00910858|O3|Outcome|Overall|All participants in the Safety population.
435304|NCT00910858|O2|Outcome|Non-responders|Participants who were not erythroid responders.
435305|NCT00910858|O1|Outcome|Responders|Participants with a erythroid response.
435306|NCT00910858|O3|Outcome|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435307|NCT00910858|O2|Outcome|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435308|NCT00910858|O1|Outcome|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435309|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435310|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435311|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
435312|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
435313|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
435314|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
435315|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
435316|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
435317|NCT00910858|E2|Reported Event|15 mg Lenalidomide|"Participants with low- or intermediate-1-risk MDS were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435364|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435318|NCT00910858|E1|Reported Event|10 mg Lenalidomide|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
435319|NCT00910845|B3|Baseline|Total|Total of all reporting groups
435320|NCT00910845|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435321|NCT00910845|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435322|NCT00910845|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435323|NCT00910845|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435324|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435325|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435326|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435327|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435328|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435329|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435330|NCT00910845|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435331|NCT00910845|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435332|NCT00910728|B10|Baseline|Total|Total of all reporting groups
435333|NCT00910728|B9|Baseline|20 mg QD|AZD1480 may be administered orally in capsules
435334|NCT00910728|B8|Baseline|10 mg BID|AZD1480 may be administered orally in capsules
435335|NCT00910728|B7|Baseline|50 mg QD|AZD1480 may be administered orally in capsules
435336|NCT00910728|B6|Baseline|30 mg QD|AZD1480 may be administered orally in capsules
435337|NCT00910728|B5|Baseline|15 mg BID|AZD1480 may be administered orally in capsules
435338|NCT00910728|B4|Baseline|70 mg QD|AZD1480 may be administered orally in capsules
435339|NCT00910728|B3|Baseline|10 mg QD|AZD1480 may be administered orally in capsules
435340|NCT00910728|B2|Baseline|5.0 mg QD|AZD1480 may be administered orally in capsules
435341|NCT00910728|B1|Baseline|2.5 mg QD|AZD1480 may be administered orally in capsules
435342|NCT00910728|P9|Participant Flow|20 mg QD|AZD1480 may be administered orally in capsules
435343|NCT00910728|P8|Participant Flow|15 mg BID|AZD1480 may be administered orally in capsules
435344|NCT00910728|P7|Participant Flow|10 mg BID|AZD1480 may be administered orally in capsules
435345|NCT00910728|P6|Participant Flow|70 mg QD|AZD1480 may be administered orally in capsules
435346|NCT00910728|P5|Participant Flow|50 mg QD|AZD1480 may be administered orally in capsules
435347|NCT00910728|P4|Participant Flow|30 mg QD|AZD1480 may be administered orally in capsules
435348|NCT00910728|P3|Participant Flow|10 mg QD|AZD1480 may be administered orally in capsules
435349|NCT00910728|P2|Participant Flow|5.0 mg QD|AZD1480 may be administered orally in capsules
435350|NCT00910728|P1|Participant Flow|2.5 mg QD|AZD1480 may be administered orally in capsules
435351|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435352|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435353|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435354|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435355|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435356|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435357|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435358|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435359|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435360|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435361|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435362|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435363|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435372|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435373|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435374|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435375|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435376|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435377|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435378|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435379|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435380|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435381|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435382|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435383|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435384|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435385|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435386|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435387|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435388|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435389|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435390|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435391|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435392|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435393|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435394|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435395|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435396|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435397|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435398|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435399|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435400|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435401|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435402|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435403|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435404|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435405|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435406|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435407|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435408|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435409|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435410|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435411|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435412|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435413|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435414|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435415|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435416|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435417|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435418|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435419|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435420|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435421|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435422|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435423|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435424|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435425|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435426|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435427|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435428|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435429|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435430|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435431|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435432|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435433|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435434|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435435|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435436|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435437|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435438|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435439|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435440|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435441|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435442|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435443|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435444|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435445|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435446|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435447|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435448|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435449|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435450|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
435451|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
435452|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
435453|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
435454|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
435455|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
435456|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
435457|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
435458|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
435459|NCT00910728|E9|Reported Event|10 mg BID|AZD1480 may be administered orally in capsules
435460|NCT00910728|E8|Reported Event|50 mg QD|AZD1480 may be administered orally in capsules
435461|NCT00910728|E7|Reported Event|30 mg QD|AZD1480 may be administered orally in capsules
435462|NCT00910728|E6|Reported Event|20 mg QD|AZD1480 may be administered orally in capsules
435463|NCT00910728|E5|Reported Event|15 mg BID|AZD1480 may be administered orally in capsules
435464|NCT00910728|E4|Reported Event|70 mg QD|AZD1480 may be administered orally in capsules
435465|NCT00910728|E3|Reported Event|10 mg QD|AZD1480 may be administered orally in capsules
435466|NCT00910728|E2|Reported Event|5.0 mg QD|AZD1480 may be administered orally in capsules
435467|NCT00910728|E1|Reported Event|2.5 mg QD|AZD1480 may be administered orally in capsules
435468|NCT00910715|B4|Baseline|Total|Total of all reporting groups
435469|NCT00910715|B3|Baseline|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
435470|NCT00910715|B2|Baseline|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
435471|NCT00910715|B1|Baseline|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
435472|NCT00910715|P3|Participant Flow|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
435473|NCT00910715|P2|Participant Flow|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
435474|NCT00910715|P1|Participant Flow|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
435475|NCT00910715|O2|Outcome|Controls|control subjects without a history of Lyme borreliosis
435476|NCT00910715|O1|Outcome|EM Patients|EM patients treated with doxycycline 100 mg b.i.d. for 10 or 15 days
435477|NCT00910715|O3|Outcome|Controls|subjects without a history of Lyme borreliosis included in the study as controls only at the 6 month follow-up time point, results are given only in the secondary outcome section
435478|NCT00910715|O2|Outcome|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
435479|NCT00910715|O1|Outcome|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
435480|NCT00910715|E3|Reported Event|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
435481|NCT00910715|E2|Reported Event|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
435482|NCT00910715|E1|Reported Event|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
435483|NCT00910689|B5|Baseline|Total|Total of all reporting groups
435484|NCT00910689|B4|Baseline|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435485|NCT00910689|B3|Baseline|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435486|NCT00910689|B2|Baseline|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435487|NCT00910689|B1|Baseline|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435488|NCT00910689|P4|Participant Flow|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435489|NCT00910689|P3|Participant Flow|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435490|NCT00910689|P2|Participant Flow|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435491|NCT00910689|P1|Participant Flow|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435492|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435493|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435494|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435495|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435496|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435497|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435498|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435499|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435500|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435501|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435502|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435503|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435504|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435505|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435506|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435507|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435508|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435509|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435510|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435511|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435512|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
435513|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
435514|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
435515|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
435516|NCT00910689|E4|Reported Event|OAT + BMM + Beta-Blocker at Month 5|"Optimal Acute Therapy (OAT)+ Behavioral Migraine Management (BMM)+ Beta-Blocker(Propranolol/Nadolol).~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side effect) assessed after dose adjustment(Month 5)."
435517|NCT00910689|E3|Reported Event|OAT + BMM + PL at Month 5|"Optimal Acute Therapy + Behavioral Migraine Management(BMM) + Beta-Blocker(Propranolol/Nadolol) Placebo.~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect)as assessed after dose adjustment(Month 5)."
435518|NCT00910689|E2|Reported Event|OAT + Beta-Blocker at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/Nadolol. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect assessed after dose adjustment(Month 5).
435519|NCT00910689|E1|Reported Event|OAT + Placebo (PL) at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/ Nadolol)Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or Other side effect at Month 5 following dose adjustment.
435520|NCT00910663|B3|Baseline|Total|Total of all reporting groups
435521|NCT00910663|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
435522|NCT00910663|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
435523|NCT00910663|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
435524|NCT00910663|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
435525|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
435526|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
435527|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
435528|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
435529|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
435530|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
435531|NCT00910663|E2|Reported Event|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
435532|NCT00910663|E1|Reported Event|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
435533|NCT00910624|B5|Baseline|Total|Total of all reporting groups
435534|NCT00910624|B4|Baseline|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435535|NCT00910624|B3|Baseline|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435536|NCT00910624|B2|Baseline|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435537|NCT00910624|B1|Baseline|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435538|NCT00910624|P4|Participant Flow|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435539|NCT00910624|P3|Participant Flow|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435540|NCT00910624|P2|Participant Flow|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435541|NCT00910624|P1|Participant Flow|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435542|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435543|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435544|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435545|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435546|NCT00910624|O1|Outcome|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435547|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435548|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435584|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435585|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435586|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435549|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435550|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435551|NCT00910624|E1|Reported Event|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
435552|NCT00910520|B3|Baseline|Total|Total of all reporting groups
435553|NCT00910520|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435554|NCT00910520|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435555|NCT00910520|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435556|NCT00910520|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435557|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435558|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435559|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435560|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435561|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435562|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435563|NCT00910520|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
435564|NCT00910520|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
435565|NCT00910299|B3|Baseline|Total|Total of all reporting groups
435566|NCT00910299|B2|Baseline|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
435567|NCT00910299|B1|Baseline|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
435568|NCT00910299|P2|Participant Flow|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
435569|NCT00910299|P1|Participant Flow|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
435570|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
435571|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
435572|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
435573|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
435574|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
435575|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
435576|NCT00910299|E2|Reported Event|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
435577|NCT00910299|E1|Reported Event|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
435578|NCT00910273|B3|Baseline|Total|Total of all reporting groups
435579|NCT00910273|B2|Baseline|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435580|NCT00910273|B1|Baseline|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435581|NCT00910273|P2|Participant Flow|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435582|NCT00910273|P1|Participant Flow|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435583|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435587|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435588|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435589|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435590|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435591|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435592|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435593|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435594|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435595|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435596|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435597|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435598|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435599|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435600|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435601|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435602|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435603|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435604|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435605|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435606|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435607|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435608|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435609|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435610|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435611|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435612|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435613|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435614|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435615|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435616|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435617|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435618|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435619|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435620|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435621|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435622|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435623|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435624|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435625|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435626|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435627|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435628|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435629|NCT00910273|E2|Reported Event|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
435630|NCT00910273|E1|Reported Event|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
435631|NCT00910091|B3|Baseline|Total|Total of all reporting groups
435632|NCT00910091|B2|Baseline|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435633|NCT00910091|B1|Baseline|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435634|NCT00910091|P2|Participant Flow|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
435635|NCT00910091|P1|Participant Flow|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435636|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435637|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435638|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435639|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435640|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435641|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435642|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435643|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435644|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435645|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435646|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435647|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435648|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435649|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435650|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435651|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435652|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435653|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435654|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435655|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435656|NCT00910091|O2|Outcome|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
435657|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435658|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
435659|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
435660|NCT00910091|E2|Reported Event|B- MA - 160mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~Megestrol Acetate (MA): MA will be administered orally as 160mg daily"
435661|NCT00910091|E1|Reported Event|A- BN 83495- 40mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~BN83495: BN83495 will be administered as a 40 mg tablet once a day orally"
435662|NCT00910039|B1|Baseline|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435663|NCT00910039|P1|Participant Flow|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435664|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435665|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435666|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435667|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435668|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435669|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435670|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435707|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
435671|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435672|NCT00910039|E1|Reported Event|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
435673|NCT00910000|B7|Baseline|Total|Total of all reporting groups
435674|NCT00910000|B6|Baseline|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435675|NCT00910000|B5|Baseline|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435676|NCT00910000|B4|Baseline|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435677|NCT00910000|B3|Baseline|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435678|NCT00910000|B2|Baseline|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435679|NCT00910000|B1|Baseline|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435680|NCT00910000|P6|Participant Flow|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435681|NCT00910000|P5|Participant Flow|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435682|NCT00910000|P4|Participant Flow|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435683|NCT00910000|P3|Participant Flow|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435684|NCT00910000|P2|Participant Flow|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435685|NCT00910000|P1|Participant Flow|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435686|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435708|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of=- Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
435941|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
435687|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435688|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435689|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435690|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435691|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435692|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435693|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435694|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435695|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435696|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435697|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435698|NCT00910000|O1|Outcome|All Phase Ib Participants|"All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9).~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
435699|NCT00910000|E1|Reported Event|All Phase Ib Participants|All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9). Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
435700|NCT00909870|B3|Baseline|Total|Total of all reporting groups
435701|NCT00909870|B2|Baseline|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
435702|NCT00909870|B1|Baseline|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
435703|NCT00909870|P2|Participant Flow|Active Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
435704|NCT00909870|P1|Participant Flow|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
435705|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
435706|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
435709|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
435710|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
435711|NCT00909870|E2|Reported Event|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
435712|NCT00909870|E1|Reported Event|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
435713|NCT00909857|B3|Baseline|Total|Total of all reporting groups
435714|NCT00909857|B2|Baseline|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435715|NCT00909857|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435716|NCT00909857|P2|Participant Flow|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435717|NCT00909857|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435718|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435719|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435720|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435721|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435722|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435723|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435724|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435725|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435726|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435727|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435728|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435729|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435730|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435731|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435732|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435733|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435734|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435735|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435736|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435737|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435738|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435739|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435740|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435741|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435742|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435743|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435744|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435745|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435746|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435747|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435748|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435749|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435750|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435751|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435752|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435753|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435754|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435755|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435756|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435757|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435758|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435759|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435760|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435761|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435762|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435763|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435764|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435765|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435766|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435767|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435768|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435769|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435770|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435937|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
436071|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
435771|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435772|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435773|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435774|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435775|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435776|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435777|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435778|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435779|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435780|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435781|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435782|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435783|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435784|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435785|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435786|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435787|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435788|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435789|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435790|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435791|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435792|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435793|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435794|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435795|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435796|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435797|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435798|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435799|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435800|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435938|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
442321|NCT00890695|E2|Reported Event|2 Normal Diet|normal diet arm
435801|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435802|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435803|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435804|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435805|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435806|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435807|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435808|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435809|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435810|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435811|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435812|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435813|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435814|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435815|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435816|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435817|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435818|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435819|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435820|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435821|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435822|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435823|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435824|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435825|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435826|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435827|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435828|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435829|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435830|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435939|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
436072|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
435831|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435832|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435833|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435834|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435835|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435836|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435837|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435838|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435839|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435840|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435841|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435842|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435843|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435844|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435845|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435846|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435847|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435848|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435849|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435850|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435851|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435852|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435853|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435854|NCT00909857|E2|Reported Event|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
435855|NCT00909857|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
435856|NCT00909844|B1|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
435857|NCT00909844|P1|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
435858|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435859|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435860|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435940|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
435861|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435862|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435863|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435864|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435865|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435866|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435867|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435868|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435869|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435870|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435871|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
435872|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
435873|NCT00909844|E1|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
435874|NCT00909792|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
435875|NCT00909792|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
435876|NCT00909792|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.
435877|NCT00909792|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
435878|NCT00909792|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
435879|NCT00909792|E2|Reported Event|Senofilcon A|Silicone hydrogel, soft, multifocal contact lens
435880|NCT00909792|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens
435881|NCT00909779|B3|Baseline|Total|Total of all reporting groups
435882|NCT00909779|B2|Baseline|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435883|NCT00909779|B1|Baseline|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435884|NCT00909779|P2|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435885|NCT00909779|P1|Participant Flow|Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435886|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435887|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435888|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435889|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435890|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435891|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435892|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435893|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435894|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435895|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435896|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435897|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435898|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435899|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435900|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435901|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
435902|NCT00909779|O2|Outcome|Placebo|Placebo twice daily
435903|NCT00909779|O1|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435904|NCT00909779|E2|Reported Event|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435905|NCT00909779|E1|Reported Event|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
435906|NCT00909753|B3|Baseline|Total|Total of all reporting groups
435907|NCT00909753|B2|Baseline|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
435908|NCT00909753|B1|Baseline|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
435909|NCT00909753|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
435910|NCT00909753|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
435911|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435912|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435913|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435914|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435915|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435916|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435917|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435918|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435919|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435920|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435921|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435922|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435923|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435924|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435925|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
435926|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
435927|NCT00909727|B3|Baseline|Total|Total of all reporting groups
435928|NCT00909727|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
435929|NCT00909727|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
435930|NCT00909727|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
435931|NCT00909727|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
435932|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
435933|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
435934|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
435935|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
435936|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
435942|NCT00909727|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
435943|NCT00909727|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
435944|NCT00909649|B3|Baseline|Total|Total of all reporting groups
435945|NCT00909649|B2|Baseline|Non Fibrin Group|
435946|NCT00909649|B1|Baseline|Fibrin Group|
435947|NCT00909649|P2|Participant Flow|Non Fibrin Group|
435948|NCT00909649|P1|Participant Flow|Fibrin Group|
435949|NCT00909649|O2|Outcome|Non Fibrin Group|
435950|NCT00909649|O1|Outcome|Fibrin Group|
435951|NCT00909610|B3|Baseline|Total|Total of all reporting groups
435952|NCT00909610|B2|Baseline|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
435953|NCT00909610|B1|Baseline|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
435954|NCT00909610|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
435955|NCT00909610|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
435956|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435957|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
435958|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435959|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
435960|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435961|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
435962|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435963|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
435964|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435965|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
435966|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435967|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
435968|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435969|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
435970|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
435971|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period
435972|NCT00909545|B5|Baseline|Total|Total of all reporting groups
435973|NCT00909545|B4|Baseline|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
435974|NCT00909545|B3|Baseline|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
435975|NCT00909545|B2|Baseline|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
435976|NCT00909545|B1|Baseline|Placebo|4 Placebo to Match (PTM) tablets once daily
435977|NCT00909545|P4|Participant Flow|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
435978|NCT00909545|P3|Participant Flow|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
435979|NCT00909545|P2|Participant Flow|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
435980|NCT00909545|P1|Participant Flow|Placebo|4 Placebo to Match (PTM) tablets once daily
435981|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
435982|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
435983|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
435984|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
435985|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
435986|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
435987|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
435988|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
435989|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
435990|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
435991|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
435992|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
435993|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
435994|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
435995|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
435996|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
435997|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
435998|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
435999|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436000|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436001|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436002|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436003|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436004|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436005|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436006|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436007|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436008|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436009|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436010|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436011|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436012|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436013|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436014|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436015|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436016|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436017|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436018|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436019|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436020|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436021|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436022|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436023|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436024|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436025|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436026|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436027|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436028|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436029|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436030|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436031|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436032|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436033|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436034|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436035|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436036|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436037|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436038|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436039|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436040|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436041|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436042|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436043|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436044|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436045|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436046|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436047|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436048|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436049|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436050|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436051|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436052|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436053|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436054|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436055|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436056|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436057|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436058|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436059|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436060|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436061|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436062|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436063|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436064|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436065|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436066|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436067|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436068|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436069|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436070|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436073|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436074|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436075|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436076|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436077|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436078|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436079|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436080|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436081|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436082|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436083|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436084|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436085|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436086|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436087|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436088|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436089|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436090|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436091|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436092|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436093|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436094|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436095|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436096|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436097|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436098|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436099|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436100|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436101|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436102|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436103|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436104|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436105|NCT00909545|O4|Outcome|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
436106|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436107|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436108|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
436109|NCT00909545|E4|Reported Event|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
436110|NCT00909545|E3|Reported Event|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
436111|NCT00909545|E2|Reported Event|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
436112|NCT00909545|E1|Reported Event|Placebo|4 Placebo to Match (PTM) tablets once daily
436113|NCT00909532|B3|Baseline|Total|Total of all reporting groups
436114|NCT00909532|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436115|NCT00909532|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436116|NCT00909532|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436117|NCT00909532|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436118|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436119|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436120|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436121|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436122|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436123|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436124|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436125|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436126|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablets of 150 mg of ivacaftor q12h for up to 48 weeks.
436127|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436128|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436129|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436130|NCT00909532|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
436131|NCT00909532|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
436132|NCT00909480|B3|Baseline|Total|Total of all reporting groups
436133|NCT00909480|B2|Baseline|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436134|NCT00909480|B1|Baseline|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436135|NCT00909480|P2|Participant Flow|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436213|NCT00909181|B1|Baseline|Oxybutynin Gel 56 mg/Day|
436136|NCT00909480|P1|Participant Flow|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436137|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436138|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436139|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436140|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436141|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436142|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436143|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436144|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436145|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436146|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436147|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436148|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436149|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436150|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436151|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436152|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436153|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436154|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436155|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436156|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436157|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436158|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436159|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436160|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436161|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436162|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436163|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436164|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436165|NCT00909480|E2|Reported Event|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
436166|NCT00909480|E1|Reported Event|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
436167|NCT00909428|B4|Baseline|Total|Total of all reporting groups
436168|NCT00909428|B3|Baseline|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
436169|NCT00909428|B2|Baseline|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
436170|NCT00909428|B1|Baseline|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
436171|NCT00909428|P3|Participant Flow|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
436172|NCT00909428|P2|Participant Flow|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
436173|NCT00909428|P1|Participant Flow|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI).
436174|NCT00909428|O2|Outcome|One Month Maximal Cystometric Capacity|All patients with DOI or USI had their maximal cystometric capacity recorded following 30 days of treatment with daily 10mg solifenacin succinate.
436175|NCT00909428|O1|Outcome|Baseline Maximal Cystometric Capacity|All patients with DOI or USI had their baseline maximal cystometric capacity recorded
436176|NCT00909428|E3|Reported Event|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
436177|NCT00909428|E2|Reported Event|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
436178|NCT00909428|E1|Reported Event|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
436179|NCT00909389|B1|Baseline|Filipino Patients With Hypercholesterolemia|
436180|NCT00909389|P1|Participant Flow|Filipino Patients With Hypercholesterolemia|
436181|NCT00909389|O1|Outcome|Filipino Patients With Hypercholesterolemia|
436182|NCT00909389|E1|Reported Event|Filipino Patients With Hypercholesterolemia|
436183|NCT00909324|B3|Baseline|Total|Total of all reporting groups
436184|NCT00909324|B2|Baseline|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
436185|NCT00909324|B1|Baseline|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
436214|NCT00909181|P3|Participant Flow|Placebo Gel|
436215|NCT00909181|P2|Participant Flow|Oxybutynin Gel 84 mg/Day|
436186|NCT00909324|P2|Participant Flow|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
436187|NCT00909324|P1|Participant Flow|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
436188|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
436189|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
436190|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
436191|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
436192|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
436193|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
436194|NCT00909324|E2|Reported Event|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
436195|NCT00909324|E1|Reported Event|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
436196|NCT00909220|B3|Baseline|Total|Total of all reporting groups
436197|NCT00909220|B2|Baseline|Healthy Participants|participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled for assessment over 16 weeks. Additional inclusion criteria specified that participants should be between ages 18 and 65 years, medically healthy, medication-free, and with no medication washout. Exclusion criteria included lifetime bipolar disorder, psychosis, obsessive-compulsive disorder, substance abuse/dependence, and several personality disorders (i.e., borderline, schizoid, schizotypal, antisocial).).
436198|NCT00909220|B1|Baseline|Current Major Depressive Disorder|"participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986).~Additional inclusion criteria specified that participants should be between ages 18 and 65 years, medically healthy, medication-free, and with no medication washout. Exclusion criteria included lifetime bipolar disorder, psychosis, obsessive-compulsive disorder, substance abuse/dependence, and several personality disorders (i.e., borderline, schizoid, schizotypal, antisocial).~Behavioral Activation: 16 weekly study visits aimed at identifying avoidance patterns used in social or physical situations that contribute to depression and replacing them with reinforcing experiences using directive behavioral strategies."
436199|NCT00909220|P2|Participant Flow|Healthy Participants|Another 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled for assessment over 16 weeks
436200|NCT00909220|P1|Participant Flow|Current Major Depressive Disorder|"Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986) were enrolled into a treatment study at Northwestern University’s Feinberg School of Medicine in Chicago, Illinois.~Behavioral Activation: 16 weekly study visits aimed at identifying avoidance patterns used in social or physical situations that contribute to depression and replacing them with reinforcing experiences using directive behavioral strategies"
436201|NCT00909220|O1|Outcome|Current Major Depressive Disorder|participants diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID; First, Spitzer, Gibbon, & Williams, 2002) and a score > 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C; Rush et al., 2003; Rush et al., 1986).
436202|NCT00909220|O2|Outcome|Healthy Participants|Healthy participants were enrolled with no lifetime history or current presentation of psychiatric symptoms per the SCID and a score < 11 on the IDS-C.
436203|NCT00909220|O1|Outcome|Current Major Depressive Disorder|participants diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID; First, Spitzer, Gibbon, & Williams, 2002) and a score > 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C; Rush et al., 2003; Rush et al., 1986).
436204|NCT00909220|O2|Outcome|Healthy Participants|An additional 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled
436205|NCT00909220|O1|Outcome|Current Major Depressive Disorder|Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA. DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986).
436206|NCT00909220|O2|Outcome|Healthy Participants|An additional 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled
436207|NCT00909220|O1|Outcome|Current Major Depressive Disorder|Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA. DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986).
436208|NCT00909220|E2|Reported Event|Healthy Participants|No lifetime history or current presentation of psychiatric symptoms per the SCID and a score ≤ 11 on the IDS-C.
436209|NCT00909220|E1|Reported Event|Current Major Depressive Disorder|Diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID) and a score ≥ 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C).
436210|NCT00909181|B4|Baseline|Total|Total of all reporting groups
436211|NCT00909181|B3|Baseline|Placebo Gel|
436212|NCT00909181|B2|Baseline|Oxybutynin Gel 84 mg/Day|
436224|NCT00909155|B3|Baseline|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
436225|NCT00909155|B2|Baseline|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
436226|NCT00909155|B1|Baseline|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
436227|NCT00909155|P3|Participant Flow|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
436228|NCT00909155|P2|Participant Flow|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
436229|NCT00909155|P1|Participant Flow|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT).~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
436230|NCT00909155|O3|Outcome|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
436231|NCT00909155|O2|Outcome|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
436232|NCT00909155|O1|Outcome|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
436233|NCT00909155|E3|Reported Event|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
436234|NCT00909155|E2|Reported Event|Currently Depressed Subjects; Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
436235|NCT00909155|E1|Reported Event|Currently Depressed Subjects; Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT.~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
436236|NCT00909064|B1|Baseline|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
436237|NCT00909064|P1|Participant Flow|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
436238|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
436239|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
436240|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
436241|NCT00909064|E1|Reported Event|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
436242|NCT00909038|B1|Baseline|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436243|NCT00909038|P1|Participant Flow|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436244|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436245|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436246|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436247|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436248|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436665|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
436249|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436250|NCT00909038|E1|Reported Event|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
436251|NCT00908960|B4|Baseline|Total|Total of all reporting groups
436252|NCT00908960|B3|Baseline|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
436253|NCT00908960|B2|Baseline|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436254|NCT00908960|B1|Baseline|High TFMP: Enoxaparin|"Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).~Only patients with high TFMP status at baseline were randomized to treatment or observation."
436255|NCT00908960|P3|Participant Flow|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
436256|NCT00908960|P2|Participant Flow|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436257|NCT00908960|P1|Participant Flow|High TFMP: Enoxaparin|Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436258|NCT00908960|O3|Outcome|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
436259|NCT00908960|O2|Outcome|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436260|NCT00908960|O1|Outcome|High TFMP: Enoxaparin|Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436261|NCT00908960|O3|Outcome|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
436262|NCT00908960|O2|Outcome|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436263|NCT00908960|O1|Outcome|High TFMP: Enoxaparin|Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436264|NCT00908960|O3|Outcome|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
436265|NCT00908960|O2|Outcome|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436266|NCT00908960|O1|Outcome|High TFMP: Enoxaparin|Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436267|NCT00908960|E3|Reported Event|Low TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.
436268|NCT00908960|E2|Reported Event|High TFMP: Observation|Patients undergo observation until evaluation with lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
436269|NCT00908960|E1|Reported Event|High TFMP: Enoxaparin|"Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).~Only patients with high TFMP status at baseline were randomized to treatment or observation."
436270|NCT00908908|B1|Baseline|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
436271|NCT00908908|P1|Participant Flow|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
436272|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
436273|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
436274|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
436275|NCT00908908|E1|Reported Event|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
436276|NCT00908895|B3|Baseline|Total|Total of all reporting groups
436277|NCT00908895|B2|Baseline|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
436278|NCT00908895|B1|Baseline|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
436279|NCT00908895|P2|Participant Flow|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
436280|NCT00908895|P1|Participant Flow|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
436281|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
436282|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
436283|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
436284|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
436285|NCT00908895|E2|Reported Event|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
436286|NCT00908895|E1|Reported Event|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
436287|NCT00908882|B3|Baseline|Total|Total of all reporting groups
436288|NCT00908882|B2|Baseline|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436289|NCT00908882|B1|Baseline|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436290|NCT00908882|P2|Participant Flow|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436291|NCT00908882|P1|Participant Flow|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436292|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436293|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436294|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436295|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436296|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436297|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436298|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436299|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436300|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436301|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436302|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436303|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436304|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436305|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436306|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436337|NCT00908687|E2|Reported Event|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436338|NCT00908687|E1|Reported Event|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
436307|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436308|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436309|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436310|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
436311|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436312|NCT00908882|E2|Reported Event|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke received standard of care for smoking cessation and use the standard PTSD Health Buddy
436313|NCT00908882|E1|Reported Event|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
436314|NCT00908687|B7|Baseline|Total|Total of all reporting groups
436315|NCT00908687|B6|Baseline|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436316|NCT00908687|B5|Baseline|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436317|NCT00908687|B4|Baseline|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
436318|NCT00908687|B3|Baseline|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436319|NCT00908687|B2|Baseline|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436320|NCT00908687|B1|Baseline|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
436321|NCT00908687|P6|Participant Flow|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436322|NCT00908687|P5|Participant Flow|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436323|NCT00908687|P4|Participant Flow|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
436324|NCT00908687|P3|Participant Flow|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436325|NCT00908687|P2|Participant Flow|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436326|NCT00908687|P1|Participant Flow|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
436327|NCT00908687|O6|Outcome|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436328|NCT00908687|O5|Outcome|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436329|NCT00908687|O4|Outcome|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
436330|NCT00908687|O3|Outcome|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436331|NCT00908687|O2|Outcome|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436332|NCT00908687|O1|Outcome|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
436333|NCT00908687|E6|Reported Event|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436334|NCT00908687|E5|Reported Event|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
436335|NCT00908687|E4|Reported Event|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
436336|NCT00908687|E3|Reported Event|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
436339|NCT00908648|B3|Baseline|Total|Total of all reporting groups
436340|NCT00908648|B2|Baseline|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
436341|NCT00908648|B1|Baseline|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
436342|NCT00908648|P2|Participant Flow|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
436343|NCT00908648|P1|Participant Flow|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
436344|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
436345|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
436346|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
436347|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
436348|NCT00908596|B5|Baseline|Total|Total of all reporting groups
436349|NCT00908596|B4|Baseline|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436350|NCT00908596|B3|Baseline|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436351|NCT00908596|B2|Baseline|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436352|NCT00908596|B1|Baseline|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436353|NCT00908596|P4|Participant Flow|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436354|NCT00908596|P3|Participant Flow|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436355|NCT00908596|P2|Participant Flow|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436356|NCT00908596|P1|Participant Flow|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436357|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436358|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436359|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436360|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436361|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436362|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436363|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436364|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436365|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436366|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436367|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436368|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436369|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436370|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436666|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
436371|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436372|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436373|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436374|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436375|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436376|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436377|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436378|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436379|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436380|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436381|NCT00908596|E4|Reported Event|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436382|NCT00908596|E3|Reported Event|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436383|NCT00908596|E2|Reported Event|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436384|NCT00908596|E1|Reported Event|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
436385|NCT00908583|B1|Baseline|All Study Participants|Combined study participants, all phases.
436386|NCT00908583|P1|Participant Flow|All Study Participants|Combined study participants all phases.
436387|NCT00908583|O1|Outcome|All Transplanted Participants|Combined phases, transplanted patients.
436388|NCT00908583|O1|Outcome|All Study Participants|All study participants combined.4 participants were enrolled in multiple groups or phases. They are only counted once.
436389|NCT00908583|O1|Outcome|All Study Participants|All study participants combined. Counting participants only once even though 7 participants were enrolled in multiple phases.
436390|NCT00908583|O8|Outcome|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436391|NCT00908583|O7|Outcome|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436392|NCT00908583|O6|Outcome|Phase 3, Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436393|NCT00908583|O5|Outcome|Phase 3, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436394|NCT00908583|O4|Outcome|Phase 2 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436395|NCT00908583|O3|Outcome|Phase 2, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436396|NCT00908583|O2|Outcome|Phase 1 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436397|NCT00908583|O1|Outcome|Phase 1, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436398|NCT00908583|E5|Reported Event|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436399|NCT00908583|E4|Reported Event|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436400|NCT00908583|E3|Reported Event|Phase 3|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436401|NCT00908583|E2|Reported Event|Phase 2, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436402|NCT00908583|E1|Reported Event|Phase 1, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
436403|NCT00908388|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
436404|NCT00908388|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
436405|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
436406|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
436407|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
436408|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
436409|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
436410|NCT00908388|E1|Reported Event|GORE Conformable TAG® Device Surgical Implant|
436411|NCT00908375|B3|Baseline|Total|Total of all reporting groups
436412|NCT00908375|B2|Baseline|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
436413|NCT00908375|B1|Baseline|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
436414|NCT00908375|P2|Participant Flow|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
436415|NCT00908375|P1|Participant Flow|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
436416|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
436417|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
436418|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
436419|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
436420|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
436421|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
436422|NCT00908375|E2|Reported Event|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
436423|NCT00908375|E1|Reported Event|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
436424|NCT00908349|B1|Baseline|Oxcarbazepine XR|"Open Label Study~Oxcarbazepine XR: Open Label Study"
436425|NCT00908349|P1|Participant Flow|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
436426|NCT00908349|O1|Outcome|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
436427|NCT00908349|E1|Reported Event|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
436428|NCT00908310|B1|Baseline|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
436429|NCT00908310|P1|Participant Flow|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
436430|NCT00908310|O1|Outcome|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
436431|NCT00908310|E1|Reported Event|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
436432|NCT00908232|B1|Baseline|All Study Participants|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
436433|NCT00908232|P4|Participant Flow|SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436434|NCT00908232|P3|Participant Flow|SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8
436435|NCT00908232|P2|Participant Flow|Stable Disease: Bortezomib + Dexamethasone (VD)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436436|NCT00908232|P1|Participant Flow|Cycle 1 to 4: Bortezomib + Dexamethasone (VD)|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
436437|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436438|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436439|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436440|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436441|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436442|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436443|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436544|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436444|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436445|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436446|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436447|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436448|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436449|NCT00908232|E2|Reported Event|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
436450|NCT00908232|E1|Reported Event|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
436451|NCT00908141|B3|Baseline|Total|Total of all reporting groups
436452|NCT00908141|B2|Baseline|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
436453|NCT00908141|B1|Baseline|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
436454|NCT00908141|P2|Participant Flow|Group B:Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
436455|NCT00908141|P1|Participant Flow|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
436456|NCT00908141|O2|Outcome|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
436457|NCT00908141|O1|Outcome|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
436458|NCT00908141|E2|Reported Event|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
436459|NCT00908141|E1|Reported Event|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
436460|NCT00908128|B3|Baseline|Total|Total of all reporting groups
436461|NCT00908128|B2|Baseline|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436462|NCT00908128|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436463|NCT00908128|P2|Participant Flow|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436464|NCT00908128|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436465|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
436466|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
436467|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
436468|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
436469|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
436470|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
436471|NCT00908115|B1|Baseline|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
436472|NCT00908115|P1|Participant Flow|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
436473|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
436474|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
436475|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
436476|NCT00908115|E1|Reported Event|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
436477|NCT00908076|B3|Baseline|Total|Total of all reporting groups
436478|NCT00908076|B2|Baseline|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436479|NCT00908076|B1|Baseline|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436480|NCT00908076|P2|Participant Flow|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436481|NCT00908076|P1|Participant Flow|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436482|NCT00908076|O2|Outcome|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436483|NCT00908076|O1|Outcome|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436484|NCT00908076|E2|Reported Event|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436485|NCT00908076|E1|Reported Event|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
436486|NCT00908037|B8|Baseline|Total|Total of all reporting groups
436487|NCT00908037|B7|Baseline|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
436488|NCT00908037|B6|Baseline|Part 2 (Randomized Period) Cohort 3-Placebo|Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436489|NCT00908037|B5|Baseline|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of &lt;27 kg received 25 mg QD and par with a weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD and par with a weight of &gt;=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
436490|NCT00908037|B4|Baseline|Part 2 (Randomized Period) Cohort 2-Placebo|Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of &lt;=27 kg received 25 mg QD and par with a body weight of &gt;=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
436491|NCT00908037|B3|Baseline|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
436492|NCT00908037|B2|Baseline|Part 2 (Randomized Period) Cohort 1-Placebo|Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
436667|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
436668|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
436493|NCT00908037|B1|Baseline|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
436494|NCT00908037|P12|Participant Flow|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436495|NCT00908037|P11|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436496|NCT00908037|P10|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436497|NCT00908037|P9|Participant Flow|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436498|NCT00908037|P8|Participant Flow|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436499|NCT00908037|P7|Participant Flow|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436500|NCT00908037|P6|Participant Flow|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436501|NCT00908037|P5|Participant Flow|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436502|NCT00908037|P4|Participant Flow|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436503|NCT00908037|P3|Participant Flow|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436504|NCT00908037|P2|Participant Flow|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436505|NCT00908037|P1|Participant Flow|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436669|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
436670|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
442656|NCT00888849|E1|Reported Event|Stapling|
436506|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436507|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436508|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436509|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436510|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436511|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436512|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436513|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436514|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436515|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, as approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436516|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436671|NCT00907881|B1|Baseline|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
436517|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436518|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436519|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose eltrombopag was 37.5 mg QD. The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436520|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436521|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436522|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436523|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436524|NCT00908037|O1|Outcome|Part 2/ 3 Eltrombopag Open-Label Period|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
436525|NCT00908037|O2|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
436526|NCT00908037|O1|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo QD for 7 weeks.
436527|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
436528|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436529|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436952|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436530|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436531|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436532|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436533|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436534|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436535|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436536|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436537|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436538|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436539|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436540|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436541|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436542|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436543|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436545|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436546|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436547|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436548|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436549|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436550|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436551|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436552|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
436553|NCT00908037|O3|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
436554|NCT00908037|O2|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
436555|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
436556|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436557|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436807|NCT00907478|B1|Baseline|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436558|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436559|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436560|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436561|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436562|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436563|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436564|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436565|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436566|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436567|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436568|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
436569|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 7 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
436570|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
436571|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
436598|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436953|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436572|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
436573|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
436574|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
436575|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
436576|NCT00908037|O4|Outcome|Part 2/3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
436577|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
436578|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
436579|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a body weight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
436580|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the studyat 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436581|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436672|NCT00907881|P1|Participant Flow|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
436673|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
436954|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436582|NCT00908037|O1|Outcome|Part 2/ 3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436583|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436584|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436585|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436586|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436587|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436588|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436589|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436590|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436591|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436592|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436593|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436594|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436595|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436596|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436597|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436599|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436600|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436601|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436602|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436603|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436604|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436605|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436606|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436607|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436608|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436609|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436610|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436611|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436612|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436613|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436614|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436615|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436616|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436617|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436618|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436619|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436620|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436621|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436622|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436623|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436624|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436625|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436626|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436627|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436628|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436639|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
436674|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
436629|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436630|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
436631|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436632|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of &lt;=27 kg received 25 mg QD and participants with a body weight of &gt;=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436633|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436634|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436635|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436636|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436637|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
436638|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
436640|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
436675|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
436955|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436641|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436642|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
436643|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436644|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436645|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
436646|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
436647|NCT00908037|E4|Reported Event|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
436648|NCT00908037|E3|Reported Event|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of &lt;27 kg received 25 mg QD, and par with a body weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD, and with a body weight of &gt;=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
436649|NCT00908037|E2|Reported Event|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
436650|NCT00908037|E1|Reported Event|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight &lt;27 kg: 25 mg QD, Weight &gt;=27 kg: 50 mg QD; east Asian ancestry subjects Weight &lt;27 kg: 12.5 mg QD, Weight &gt;=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
436651|NCT00908011|B3|Baseline|Total|Total of all reporting groups
436652|NCT00908011|B2|Baseline|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
436653|NCT00908011|B1|Baseline|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
436654|NCT00908011|P2|Participant Flow|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
436655|NCT00908011|P1|Participant Flow|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
436656|NCT00908011|O2|Outcome|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
436657|NCT00908011|O1|Outcome|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
436658|NCT00908011|E2|Reported Event|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
436659|NCT00908011|E1|Reported Event|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
436660|NCT00907907|B3|Baseline|Total|Total of all reporting groups
436661|NCT00907907|B2|Baseline|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436662|NCT00907907|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436663|NCT00907907|P2|Participant Flow|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436664|NCT00907907|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
436676|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
436677|NCT00907881|E1|Reported Event|All Participants|
436678|NCT00907803|B4|Baseline|Total|Total of all reporting groups
436679|NCT00907803|B3|Baseline|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436680|NCT00907803|B2|Baseline|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436681|NCT00907803|B1|Baseline|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436682|NCT00907803|P3|Participant Flow|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436683|NCT00907803|P2|Participant Flow|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436684|NCT00907803|P1|Participant Flow|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436685|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436686|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436687|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436688|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436689|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436690|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436691|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436692|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436693|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436694|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436695|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436696|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436697|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436698|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436699|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436700|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436701|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436702|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436703|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436704|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436705|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436706|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436707|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436708|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436709|NCT00907803|E3|Reported Event|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
436710|NCT00907803|E2|Reported Event|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
436711|NCT00907803|E1|Reported Event|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
436712|NCT00907777|B3|Baseline|Total|Total of all reporting groups
436713|NCT00907777|B2|Baseline|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436714|NCT00907777|B1|Baseline|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436715|NCT00907777|P2|Participant Flow|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436716|NCT00907777|P1|Participant Flow|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436808|NCT00907478|P3|Participant Flow|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
444052|NCT00885170|B3|Baseline|Total|Total of all reporting groups
436717|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436718|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436719|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436720|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436721|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436722|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436723|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436724|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436725|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436726|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436727|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436728|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436729|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436730|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436731|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436732|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436733|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436809|NCT00907478|P2|Participant Flow|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436810|NCT00907478|P1|Participant Flow|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436734|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436735|NCT00907777|E2|Reported Event|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436736|NCT00907777|E1|Reported Event|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
436737|NCT00907738|B6|Baseline|Total|Total of all reporting groups
436738|NCT00907738|B5|Baseline|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
436739|NCT00907738|B4|Baseline|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
436740|NCT00907738|B3|Baseline|Base Protocol 008|vorinostat 400 mg QD
436741|NCT00907738|B2|Baseline|Base Protocol 006|vorinostat 200 mg twice daily (BID)
436742|NCT00907738|B1|Baseline|Base Protocol 001|Vorinostat 400 mg daily (QD)
436743|NCT00907738|P5|Participant Flow|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
436744|NCT00907738|P4|Participant Flow|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
436745|NCT00907738|P3|Participant Flow|Base Protocol 008|vorinostat 400 mg QD
436746|NCT00907738|P2|Participant Flow|Base Protocol 006|vorinostat 200 mg twice daily (BID)
436747|NCT00907738|P1|Participant Flow|Base Protocol 001|Vorinostat 400 mg daily (QD)
436748|NCT00907738|O5|Outcome|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
436749|NCT00907738|O4|Outcome|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
436750|NCT00907738|O3|Outcome|Base Protocol 008|vorinostat 400 mg QD
436751|NCT00907738|O2|Outcome|Base Protocol 006|vorinostat 200 mg twice daily (BID)
436752|NCT00907738|O1|Outcome|Base Protocol 001|Vorinostat 400 mg daily (QD)
436753|NCT00907738|E9|Reported Event|Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
436754|NCT00907738|E8|Reported Event|Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)|
436755|NCT00907738|E7|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)|
436756|NCT00907738|E6|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)|
436757|NCT00907738|E5|Reported Event|Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
436758|NCT00907738|E4|Reported Event|Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)|
436759|NCT00907738|E3|Reported Event|Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])|
436760|NCT00907738|E2|Reported Event|Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])|
436761|NCT00907738|E1|Reported Event|Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])|
436762|NCT00907621|B3|Baseline|Total|Total of all reporting groups
436763|NCT00907621|B2|Baseline|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
436764|NCT00907621|B1|Baseline|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
436765|NCT00907621|P2|Participant Flow|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
436784|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436811|NCT00907478|O1|Outcome|Romiplostim|Participants received once weekly romiplostim for 3 years.
436766|NCT00907621|P1|Participant Flow|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
436767|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
436768|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
436769|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
436770|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
436771|NCT00907621|E2|Reported Event|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
436772|NCT00907621|E1|Reported Event|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
436773|NCT00907517|B6|Baseline|Total|Total of all reporting groups
436774|NCT00907517|B5|Baseline|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436775|NCT00907517|B4|Baseline|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436776|NCT00907517|B3|Baseline|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436777|NCT00907517|B2|Baseline|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436778|NCT00907517|B1|Baseline|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436779|NCT00907517|P5|Participant Flow|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436780|NCT00907517|P4|Participant Flow|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436781|NCT00907517|P3|Participant Flow|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436782|NCT00907517|P2|Participant Flow|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436783|NCT00907517|P1|Participant Flow|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436806|NCT00907478|B2|Baseline|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436785|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436786|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436787|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436788|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436789|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436790|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436791|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436792|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436793|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436794|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436795|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436796|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436797|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436798|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436799|NCT00907517|E5|Reported Event|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436800|NCT00907517|E4|Reported Event|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436801|NCT00907517|E3|Reported Event|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436802|NCT00907517|E2|Reported Event|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436803|NCT00907517|E1|Reported Event|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
436804|NCT00907478|B4|Baseline|Total|Total of all reporting groups
436805|NCT00907478|B3|Baseline|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436812|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436813|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436814|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436815|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436816|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436817|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436818|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436819|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436820|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436821|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436822|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436823|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436824|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436825|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436826|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436827|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436828|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436829|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436830|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436831|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436832|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436833|NCT00907478|E4|Reported Event|Overall|Participants received once weekly romiplostim for 3 years.
436834|NCT00907478|E3|Reported Event|Cohort 3|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
436835|NCT00907478|E2|Reported Event|Cohort 2|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
436836|NCT00907478|E1|Reported Event|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
436837|NCT00907426|B4|Baseline|Total|Total of all reporting groups
436838|NCT00907426|B3|Baseline|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436839|NCT00907426|B2|Baseline|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436840|NCT00907426|B1|Baseline|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436841|NCT00907426|P3|Participant Flow|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436842|NCT00907426|P2|Participant Flow|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436843|NCT00907426|P1|Participant Flow|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436844|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436845|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436846|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436847|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436848|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436849|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436850|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436851|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436852|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436853|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
436854|NCT00907426|E3|Reported Event|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436855|NCT00907426|E2|Reported Event|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436856|NCT00907426|E1|Reported Event|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
436857|NCT00907374|B3|Baseline|Total|Total of all reporting groups
436858|NCT00907374|B2|Baseline|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
436859|NCT00907374|B1|Baseline|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
436860|NCT00907374|P2|Participant Flow|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
436861|NCT00907374|P1|Participant Flow|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
436862|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
436863|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
436864|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
436865|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
436866|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
436867|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
436868|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
436869|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
436870|NCT00907374|E2|Reported Event|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
436871|NCT00907374|E1|Reported Event|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
436872|NCT00907335|B3|Baseline|Total|Total of all reporting groups
436873|NCT00907335|B2|Baseline|Vehicle Control|Color matched facial gel vehicle control used once daily
436874|NCT00907335|B1|Baseline|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436875|NCT00907335|P2|Participant Flow|Vehicle Control|Color matched facial gel vehicle control used once daily
436876|NCT00907335|P1|Participant Flow|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436877|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
436878|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436879|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
436880|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436881|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
436882|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436883|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
436884|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436885|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
436886|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436887|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
436888|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436889|NCT00907335|E2|Reported Event|Vehicle Control|Color matched facial gel vehicle control used once daily
436890|NCT00907335|E1|Reported Event|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
436891|NCT00907257|B3|Baseline|Total|Total of all reporting groups
436892|NCT00907257|B2|Baseline|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
436893|NCT00907257|B1|Baseline|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
436894|NCT00907257|P2|Participant Flow|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
436895|NCT00907257|P1|Participant Flow|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
436896|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
436897|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
436898|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
436899|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
436900|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
436901|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
436902|NCT00907257|E2|Reported Event|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
436903|NCT00907257|E1|Reported Event|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
436904|NCT00907218|B1|Baseline|No Data Was Analyzed|
436905|NCT00907218|P1|Participant Flow|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
436906|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
436907|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
436908|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
436909|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
436946|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436947|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436948|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436949|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436950|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436951|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436910|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
436911|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
436912|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|Varenicline (Chantix): Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
436913|NCT00907218|E1|Reported Event|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
436914|NCT00907153|B3|Baseline|Total|Total of all reporting groups
436915|NCT00907153|B2|Baseline|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436916|NCT00907153|B1|Baseline|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436917|NCT00907153|P2|Participant Flow|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436918|NCT00907153|P1|Participant Flow|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436919|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436920|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436921|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436922|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436923|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436924|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436925|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436926|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436927|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436928|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436929|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436930|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436931|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436932|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436933|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436934|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436935|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436936|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436937|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436938|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436939|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436940|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436941|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436942|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436943|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436944|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436945|NCT00907153|O2|Outcome|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436956|NCT00907153|O1|Outcome|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436957|NCT00907153|E2|Reported Event|Placebo|Placebo: Placebo by mouth once daily for 12 weeks
436958|NCT00907153|E1|Reported Event|Vitamin D|Vitamin D: Vitamin D 300 mcg by mouth once daily for 12 weeks
436959|NCT00907101|B1|Baseline|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436960|NCT00907101|P1|Participant Flow|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436961|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436962|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436963|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436964|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436965|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436966|NCT00907101|E1|Reported Event|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
436967|NCT00907088|B3|Baseline|Total|Total of all reporting groups
436968|NCT00907088|B2|Baseline|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling provided in the control group, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
436969|NCT00907088|B1|Baseline|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel based on the Canadian Paediatric Society Guidelines. Nutrition counselling occurs at the 9-month visit and is repeated at the 15-month visit if the child has not transitioned into the use of a cup. Recommendations include iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
436970|NCT00907088|P2|Participant Flow|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
436971|NCT00907088|P1|Participant Flow|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
436972|NCT00907088|O2|Outcome|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
436973|NCT00907088|O1|Outcome|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
436974|NCT00907088|E2|Reported Event|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
436975|NCT00907088|E1|Reported Event|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
436976|NCT00906971|B3|Baseline|Total|Total of all reporting groups
436977|NCT00906971|B2|Baseline|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
436978|NCT00906971|B1|Baseline|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
436979|NCT00906971|P2|Participant Flow|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
436980|NCT00906971|P1|Participant Flow|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
436981|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
436982|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
436983|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
436984|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
436985|NCT00906971|E2|Reported Event|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
436986|NCT00906971|E1|Reported Event|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
436987|NCT00906945|B6|Baseline|Total|Total of all reporting groups
436988|NCT00906945|B5|Baseline|Dose Level 5 (Includes MTD-Phase II)|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436989|NCT00906945|B4|Baseline|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436990|NCT00906945|B3|Baseline|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436991|NCT00906945|B2|Baseline|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436992|NCT00906945|B1|Baseline|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436993|NCT00906945|P6|Participant Flow|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8~Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436994|NCT00906945|P5|Participant Flow|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436995|NCT00906945|P4|Participant Flow|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436996|NCT00906945|P3|Participant Flow|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436997|NCT00906945|P2|Participant Flow|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436998|NCT00906945|P1|Participant Flow|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
436999|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437000|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437001|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437002|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437003|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437004|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437005|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437006|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437007|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437008|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437009|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437010|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
437011|NCT00906945|O5|Outcome|Grade 5|
437012|NCT00906945|O4|Outcome|Grade 4|
437013|NCT00906945|O3|Outcome|Grade 3|
437014|NCT00906945|O2|Outcome|Grade 2|
437015|NCT00906945|O1|Outcome|Grade 1|
437016|NCT00906945|O1|Outcome|Phase II (MTD)|
437017|NCT00906945|O1|Outcome|Phase I (Includes Levels 1-5)|
437018|NCT00906945|E6|Reported Event|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8~Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
437019|NCT00906945|E5|Reported Event|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
437020|NCT00906945|E4|Reported Event|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
437021|NCT00906945|E3|Reported Event|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
437022|NCT00906945|E2|Reported Event|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
437023|NCT00906945|E1|Reported Event|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
437024|NCT00906789|B1|Baseline|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard CAD Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested"
437025|NCT00906789|P1|Participant Flow|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard and SoftView Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, Two types of software are tested: SoftView (TM). SoftView decreases the visibility of the ribs and clavicles on chest radiographs. OnGuard marks locations on chest radiographs meeting some of the software signs of lung nodules, a method often called Computer Aided Detection (CADe)."
437026|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
437027|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
437028|NCT00906789|O1|Outcome|Radiologists Using OnGuard Software: Difference of 1.0 and 5.1|Radiologists using OnGuard software. Two different versions were tested. OnGuard 1.0 and OnGuard 5.1. This software uses a computer algorithm to identify non-calcified lung nodules consistent with lung cancer. The value presented is the average difference in the areas under the LROC curve as demonstrated for the participating radiologists. The value for OnGuard 5.1 was subtracted from that of OnGuard 1.0, so a negative value indicates that OnGuard 5.1 had a higher value than OnGuard 1.0. The 95% confidence interval indicates that the OnGuard 5.1 was significantly improved.
437029|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
437030|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
437031|NCT00906789|E1|Reported Event|Participants|The 15 radiologists who participated
437032|NCT00906776|B3|Baseline|Total|Total of all reporting groups
437033|NCT00906776|B2|Baseline|Autogenous Bone|Autogenous bone from the patient
437034|NCT00906776|B1|Baseline|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437035|NCT00906776|P2|Participant Flow|Autogenous Bone|Autogenous bone from the patient
437036|NCT00906776|P1|Participant Flow|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437037|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
437038|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437039|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
437040|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437041|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
437042|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437043|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
437044|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437045|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
437046|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437047|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
437048|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437049|NCT00906776|E2|Reported Event|Autogenous Bone|Autogenous bone from the patient
437050|NCT00906776|E1|Reported Event|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
437051|NCT00906698|B7|Baseline|Total|Total of all reporting groups
437052|NCT00906698|B6|Baseline|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437053|NCT00906698|B5|Baseline|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437054|NCT00906698|B4|Baseline|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437055|NCT00906698|B3|Baseline|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437056|NCT00906698|B2|Baseline|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437057|NCT00906698|B1|Baseline|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437058|NCT00906698|P6|Participant Flow|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437059|NCT00906698|P5|Participant Flow|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437060|NCT00906698|P4|Participant Flow|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
437061|NCT00906698|P3|Participant Flow|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437062|NCT00906698|P2|Participant Flow|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437063|NCT00906698|P1|Participant Flow|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity
437064|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
437065|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
437066|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os
437067|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os
437068|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
437069|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
437070|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine per os
437071|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine per os
437072|NCT00906698|O2|Outcome|in Absence of Afatinib|60 mg/m^2 vinorelbine per os in absence of Afatinib
437073|NCT00906698|O1|Outcome|in Presence of Afatinib|60 mg/m^2 vinorelbine per os in presence of Afatinib
437074|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os.
437075|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os.
437076|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
437077|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
437078|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
437079|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
437080|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 and 50mg Afatinib
437081|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50mg Afatinib
437082|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
437083|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
437084|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
437085|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
437086|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
437087|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
437088|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437089|NCT00906698|O1|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437090|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437091|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437092|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437093|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437094|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437095|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437096|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437097|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437098|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437099|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437100|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437101|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437102|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437103|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437104|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437105|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437106|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437107|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437108|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437109|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437110|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437111|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437112|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437113|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437162|NCT00906399|B3|Baseline|Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks
437114|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437115|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437116|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437117|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437118|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437119|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437120|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437121|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437122|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437123|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437124|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437125|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437126|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437127|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437128|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437129|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437130|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437131|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437132|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437133|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437134|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437333|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
437135|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437136|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437137|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
437138|NCT00906698|E6|Reported Event|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
437139|NCT00906698|E5|Reported Event|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
437140|NCT00906698|E4|Reported Event|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
437141|NCT00906698|E3|Reported Event|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
437142|NCT00906698|E2|Reported Event|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
437143|NCT00906698|E1|Reported Event|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
437144|NCT00906503|B1|Baseline|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
437145|NCT00906503|P1|Participant Flow|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
437146|NCT00906503|O1|Outcome|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
437147|NCT00906503|E1|Reported Event|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
437148|NCT00906425|B3|Baseline|Total|Total of all reporting groups
437149|NCT00906425|B2|Baseline|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
437150|NCT00906425|B1|Baseline|Submerged Healing|The dental implants will be placed using a submerged healing treatment
437151|NCT00906425|P2|Participant Flow|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
437152|NCT00906425|P1|Participant Flow|Submerged Healing|The dental implants will be placed using a submerged healing treatment
437153|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
437154|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
437155|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
437156|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
437157|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
437158|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
437159|NCT00906425|E2|Reported Event|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
437160|NCT00906425|E1|Reported Event|Submerged Healing|The dental implants will be placed using a submerged healing treatment
437161|NCT00906399|B4|Baseline|Total|Total of all reporting groups
437163|NCT00906399|B2|Baseline|Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437164|NCT00906399|B1|Baseline|Placebo|Placebo every 2 weeks for 48 weeks
437165|NCT00906399|P7|Participant Flow|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437166|NCT00906399|P6|Participant Flow|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437167|NCT00906399|P5|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
437168|NCT00906399|P4|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437169|NCT00906399|P3|Participant Flow|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437170|NCT00906399|P2|Participant Flow|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437171|NCT00906399|P1|Participant Flow|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
437172|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437173|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437174|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
437175|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437176|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437177|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
437178|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437179|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437180|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
437181|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437182|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437183|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
437184|NCT00906399|E7|Reported Event|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437185|NCT00906399|E6|Reported Event|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437186|NCT00906399|E5|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
437187|NCT00906399|E4|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437188|NCT00906399|E3|Reported Event|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
437189|NCT00906399|E2|Reported Event|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
437190|NCT00906399|E1|Reported Event|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
437191|NCT00906347|B3|Baseline|Total|Total of all reporting groups
437192|NCT00906347|B2|Baseline|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437193|NCT00906347|B1|Baseline|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437194|NCT00906347|P2|Participant Flow|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437195|NCT00906347|P1|Participant Flow|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437196|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437197|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437334|NCT00905827|E3|Reported Event|Arm 3|Control Group: no training
437198|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437199|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437200|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437201|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437202|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437203|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437204|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437205|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437206|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437207|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437208|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437209|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437210|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437211|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437212|NCT00906347|E2|Reported Event|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
437213|NCT00906347|E1|Reported Event|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
437214|NCT00906282|B1|Baseline|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment given on Day 1 of each 21-day cycle:~Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes~Carboplatin: AUC 6.0, IV infused over 30-60 minutes~At weeks 15-18, surgical candidates will have resection."
437215|NCT00906282|P1|Participant Flow|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
437216|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment on Day 1 of each 21-day cycle:~Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes~Carboplatin: AUC 6.0, IV infused over 30-60 minutes~At weeks 15-18, surgical candidates will have resection."
437217|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
437218|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
437219|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
437220|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
437221|NCT00906282|E1|Reported Event|Pemetrexed/Carboplatin|All patients who received at least 1 dose of study treatment were included in the safety analysis.
437222|NCT00906243|B1|Baseline|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
437223|NCT00906243|P1|Participant Flow|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
437870|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437224|NCT00906243|O1|Outcome|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
437225|NCT00906243|E1|Reported Event|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
437226|NCT00906204|B3|Baseline|Total|Total of all reporting groups
437227|NCT00906204|B2|Baseline|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437228|NCT00906204|B1|Baseline|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437229|NCT00906204|P2|Participant Flow|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437230|NCT00906204|P1|Participant Flow|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437231|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437232|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437233|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437234|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437235|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437236|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437237|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437238|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437239|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437240|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437241|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437242|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437243|NCT00906204|E2|Reported Event|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
437244|NCT00906204|E1|Reported Event|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
437245|NCT00906178|B3|Baseline|Total|Total of all reporting groups
437246|NCT00906178|B2|Baseline|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
437247|NCT00906178|B1|Baseline|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
437248|NCT00906178|P2|Participant Flow|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
437249|NCT00906178|P1|Participant Flow|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
437250|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
437251|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
437252|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
437253|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
437254|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
437255|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
437256|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
437257|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
437258|NCT00906178|E2|Reported Event|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
437259|NCT00906178|E1|Reported Event|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
437260|NCT00906087|B1|Baseline|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
437261|NCT00906087|P1|Participant Flow|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
437262|NCT00906087|O1|Outcome|Cosopt|"Intraocular pressure and blood pressure measurements will be compared under the following conditions: 1) after washout of clinical treatment, 2) after treatment with Cosopt, and 3) after another washout of Cosopt.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
437263|NCT00906087|O1|Outcome|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
437264|NCT00906087|O1|Outcome|Cosopt|"Intraocular pressure comparison after washout of Cosopt and while on treatment with Cosopt~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
437265|NCT00906087|E2|Reported Event|Washout (no Glaucoma Medication)|After appropriate washout, no glaucoma medication was administered for 6 weeks.
437266|NCT00906087|E1|Reported Event|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
437267|NCT00906074|B3|Baseline|Total|Total of all reporting groups
437268|NCT00906074|B2|Baseline|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437269|NCT00906074|B1|Baseline|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437270|NCT00906074|P2|Participant Flow|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437271|NCT00906074|P1|Participant Flow|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437272|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437273|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437274|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437275|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437276|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437277|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437278|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437279|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437280|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437281|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437282|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437283|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437284|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437285|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437286|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437287|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437288|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437289|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437290|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437291|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437292|NCT00906074|E2|Reported Event|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
437293|NCT00906074|E1|Reported Event|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
437294|NCT00906035|B4|Baseline|Total|Total of all reporting groups
437295|NCT00906035|B3|Baseline|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437296|NCT00906035|B2|Baseline|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437297|NCT00906035|B1|Baseline|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437298|NCT00906035|P3|Participant Flow|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437299|NCT00906035|P2|Participant Flow|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437335|NCT00905827|E2|Reported Event|Arm 2|"Intervention: e-learning CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
437336|NCT00905827|E1|Reported Event|Arm 1|"Intervention: in person CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
437300|NCT00906035|P1|Participant Flow|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437301|NCT00906035|O3|Outcome|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437302|NCT00906035|O2|Outcome|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437303|NCT00906035|O1|Outcome|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437304|NCT00906035|O3|Outcome|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437305|NCT00906035|O2|Outcome|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437306|NCT00906035|O1|Outcome|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437307|NCT00906035|O3|Outcome|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437308|NCT00906035|O2|Outcome|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437309|NCT00906035|O1|Outcome|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437337|NCT00905632|B8|Baseline|Total|Total of all reporting groups
437338|NCT00905632|B7|Baseline|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437871|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437310|NCT00906035|E3|Reported Event|Aspirin 25 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.~Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437311|NCT00906035|E2|Reported Event|Dipyridamole 200 mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437312|NCT00906035|E1|Reported Event|Dipyridamole 200mg and Aspirin 25mg Bid|"All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.~Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study."
437313|NCT00905840|B1|Baseline|Two Bone Level Implants in Interforaminal Region|"All patients received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon alloy. All implants were 3.3 mm in Ø, had a similar macro- and micro-structure, and had the chemically modified SLActive (Sand blasted Large grid Acid-etched) surface.~The implants were placed in the interforaminal region of the mandible, one implant in each side.~Implant placement was double-blinded as the implants are visually identical, and the study was unblinded after 12 month for the first analysis."
437314|NCT00905840|P1|Participant Flow|Titan Grade IV Implant and Titan Zircon Implant|Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Titan Zircon in the interforaminal region.
437315|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
437316|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
437317|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
437318|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
437319|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
437320|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
437321|NCT00905840|E1|Reported Event|Two Bone Level Implants in Interforaminal Region|Patients with edentulous mandibles received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
437322|NCT00905827|B4|Baseline|Total|Total of all reporting groups
437323|NCT00905827|B3|Baseline|Control|Control: no training
437324|NCT00905827|B2|Baseline|Intervention: E-training CAMS|Intervention: e-training CAMS training for providers
437325|NCT00905827|B1|Baseline|Intervention 1: In-person CAMS|Intervention: in-person CAMS training for providers
437326|NCT00905827|P3|Participant Flow|Control|Control: no training
437327|NCT00905827|P2|Participant Flow|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
437328|NCT00905827|P1|Participant Flow|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
437329|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
437330|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
437331|NCT00905827|O3|Outcome|Control|Control: no training
437332|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
437339|NCT00905632|B6|Baseline|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437340|NCT00905632|B5|Baseline|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437341|NCT00905632|B4|Baseline|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437342|NCT00905632|B3|Baseline|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437343|NCT00905632|B2|Baseline|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437344|NCT00905632|B1|Baseline|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437345|NCT00905632|P7|Participant Flow|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
437346|NCT00905632|P6|Participant Flow|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
437347|NCT00905632|P5|Participant Flow|Treatment Experienced (TE): BI 207127 400 mg|Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
437348|NCT00905632|P4|Participant Flow|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
437349|NCT00905632|P3|Participant Flow|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
437350|NCT00905632|P2|Participant Flow|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
437351|NCT00905632|P1|Participant Flow|Treatment Naive (TN): Placebo|Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
437352|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437353|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437354|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437355|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437356|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437357|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437358|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437359|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437360|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437361|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437362|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437363|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437364|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437365|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437366|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437367|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437368|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437369|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437370|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437371|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437372|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437373|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437374|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437375|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437376|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437377|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437378|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437379|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437380|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437381|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437382|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437383|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437384|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437385|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437386|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437387|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437388|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437389|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437390|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437391|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437392|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437393|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437394|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437395|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437396|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437397|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437398|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437399|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437400|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437401|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437402|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437403|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437404|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437405|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437406|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437407|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437408|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437409|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437410|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437411|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437412|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437413|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437414|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437415|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437416|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437417|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437418|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437419|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437420|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437421|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437422|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437423|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437424|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437425|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437426|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437427|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437428|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437429|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437430|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437431|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437432|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437433|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437434|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437435|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437436|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437437|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437438|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437439|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437440|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437441|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437442|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437443|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437444|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437445|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437446|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437447|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437448|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437449|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437450|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437451|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437452|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437453|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437454|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437455|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437456|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437457|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437458|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437459|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437460|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437461|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437462|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437463|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437464|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437465|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437466|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437467|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437468|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437469|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437470|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437471|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437472|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437473|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437474|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437475|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437476|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437477|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437478|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437479|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437480|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437481|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437482|NCT00905632|E4|Reported Event|BI 207127 800 mg|patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437483|NCT00905632|E3|Reported Event|BI 207127 600 mg|patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437484|NCT00905632|E2|Reported Event|BI 207127 400 mg|patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
437485|NCT00905632|E1|Reported Event|Placebo|patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
437486|NCT00905606|B3|Baseline|Total|Total of all reporting groups
437487|NCT00905606|B2|Baseline|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product, dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product, dosed in second period
437488|NCT00905606|B1|Baseline|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product, dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product, dosed in second period
437489|NCT00905606|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product dosed in second period
437490|NCT00905606|P1|Participant Flow|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product dosed in second period.
437491|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
437492|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
437493|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
437494|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
437495|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
437496|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
437497|NCT00905580|B3|Baseline|Total|Total of all reporting groups
437498|NCT00905580|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
437499|NCT00905580|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
437500|NCT00905580|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
437501|NCT00905580|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
437502|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
437503|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
437504|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
437505|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
437506|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
437507|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
437508|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
437509|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
437510|NCT00905580|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
437511|NCT00905580|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
437512|NCT00905567|B3|Baseline|Total|Total of all reporting groups
437513|NCT00905567|B2|Baseline|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
437514|NCT00905567|B1|Baseline|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
437515|NCT00905567|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
437516|NCT00905567|P1|Participant Flow|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
437517|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
437518|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
437519|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
437520|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
437521|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
437522|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
437523|NCT00905554|B3|Baseline|Total|Total of all reporting groups
437524|NCT00905554|B2|Baseline|Air Insufflation|air insufflation during the insertion phase of colonoscopy
437525|NCT00905554|B1|Baseline|Warm Water|warm water irrigation during the insertion phase of colonoscopy
437526|NCT00905554|P2|Participant Flow|Air Insufflation|air insufflation during the insertion phase of colonoscopy
437527|NCT00905554|P1|Participant Flow|Warm Water|warm water irrigation during the insertion phase of colonoscopy
437528|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
437529|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
437530|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
437531|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
437532|NCT00905554|E2|Reported Event|Air Insufflation|air insufflation during the insertion phase of colonoscopy
437533|NCT00905554|E1|Reported Event|Warm Water|warm water irrigation during the insertion phase of colonoscopy
437534|NCT00905515|B4|Baseline|Total|Total of all reporting groups
437535|NCT00905515|B3|Baseline|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
437536|NCT00905515|B2|Baseline|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
437537|NCT00905515|B1|Baseline|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
437538|NCT00905515|P3|Participant Flow|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
437539|NCT00905515|P2|Participant Flow|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced Tacrolimus (TAC) with target trough levels 3.0-5.9 ng/mL."
437540|NCT00905515|P1|Participant Flow|Remaining on CsA|Stable transplant recipients randomly assigned to continue on Cyclosporine (CsA( with a target trough level of 50-250 ng/mL.
437541|NCT00905515|O3|Outcome|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
437542|NCT00905515|O2|Outcome|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced TAC with target trough levels 3.0-5.9 ng/mL."
437543|NCT00905515|O1|Outcome|Remaining on CsA|Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
437544|NCT00905515|E3|Reported Event|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
437545|NCT00905515|E2|Reported Event|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
437546|NCT00905515|E1|Reported Event|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
437547|NCT00905489|B1|Baseline|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
437548|NCT00905489|P1|Participant Flow|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
437549|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
437550|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
437551|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
437552|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
437553|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
437554|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
437555|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
437556|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
437557|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
437558|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
437559|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
437560|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
437561|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
437562|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
437563|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
437564|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
437565|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
437566|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
437567|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
437568|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
437569|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
437570|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
437571|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
437572|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
437573|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
437574|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
437575|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437576|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437577|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437578|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437579|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437580|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437581|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437582|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437583|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437584|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437585|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437586|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437587|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437588|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437589|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437590|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437591|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
437592|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
437593|NCT00905489|E1|Reported Event|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
437594|NCT00905437|B3|Baseline|Total|Total of all reporting groups
437595|NCT00905437|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437596|NCT00905437|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437597|NCT00905437|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437598|NCT00905437|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437599|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437600|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437601|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437602|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437603|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437604|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437605|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437606|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437607|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437608|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437609|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437610|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437611|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437612|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437613|NCT00905437|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
437614|NCT00905437|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
437615|NCT00905424|B3|Baseline|Total|Total of all reporting groups
437616|NCT00905424|B2|Baseline|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
437617|NCT00905424|B1|Baseline|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
437618|NCT00905424|P2|Participant Flow|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
437872|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437619|NCT00905424|P1|Participant Flow|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
437620|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437621|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437622|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437623|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437624|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437625|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437626|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437627|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437628|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437629|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437630|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437631|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437632|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437633|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437634|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437635|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437636|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437637|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437638|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437639|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437640|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437641|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437642|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437643|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437644|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437645|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437646|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437873|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437647|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437648|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437649|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437650|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437651|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437652|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437653|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437654|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
437655|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
437656|NCT00905424|E2|Reported Event|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
437657|NCT00905424|E1|Reported Event|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
437658|NCT00905359|B3|Baseline|Total|Total of all reporting groups
437659|NCT00905359|B2|Baseline|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437660|NCT00905359|B1|Baseline|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437661|NCT00905359|P2|Participant Flow|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437662|NCT00905359|P1|Participant Flow|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437663|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437664|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437665|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437666|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437782|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437667|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437668|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437669|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437670|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437671|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437672|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437673|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437674|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437675|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437676|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437677|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437678|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437679|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437680|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437681|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437682|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437683|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437684|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437685|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437686|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437687|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437688|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437689|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437690|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437691|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437692|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437693|NCT00905359|E2|Reported Event|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
437694|NCT00905359|E1|Reported Event|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
437695|NCT00905346|B3|Baseline|Total|Total of all reporting groups
437696|NCT00905346|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
437697|NCT00905346|B1|Baseline|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
437698|NCT00905346|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
437699|NCT00905346|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules 2 x 25 mg (reference) dosed in second period
437700|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
437701|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
437702|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
437703|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
437704|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
437705|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
437706|NCT00905307|B7|Baseline|Total|Total of all reporting groups
437707|NCT00905307|B6|Baseline|Placebo|Placebo QD for 6 weeks
437708|NCT00905307|B5|Baseline|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437709|NCT00905307|B4|Baseline|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437710|NCT00905307|B3|Baseline|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437711|NCT00905307|B2|Baseline|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437712|NCT00905307|B1|Baseline|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437713|NCT00905307|P6|Participant Flow|Placebo|Placebo QD for 6 weeks
437714|NCT00905307|P5|Participant Flow|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437715|NCT00905307|P4|Participant Flow|OPC-34712 High Dose|5.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437716|NCT00905307|P3|Participant Flow|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437717|NCT00905307|P2|Participant Flow|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437718|NCT00905307|P1|Participant Flow|OPC-34712 0.25 mg|0.25 mg once daily (QD) for 6 weeks
437719|NCT00905307|O6|Outcome|Placebo|Placebo QD
437720|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437721|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
437722|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437723|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physicna could request a dose increase, if needed for efficacy, based on clinical judgment.
437724|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437725|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
437726|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437727|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437728|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437729|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437730|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437731|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
437732|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437733|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437734|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437735|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437736|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437737|NCT00905307|O6|Outcome|Placebo|Placebo QD
437738|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437739|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437740|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437741|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437742|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
437743|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
437744|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437745|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437869|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437746|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437747|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437748|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437749|NCT00905307|O6|Outcome|Placebo|Placebo QD
437750|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437751|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437752|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437753|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
437754|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
437755|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
437756|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg.After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437757|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437758|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437759|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437760|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437761|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
437762|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
437763|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
437764|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment , the physician could request a dose increase, if needed for efficacy, based on clinical judgment
437765|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
437766|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437767|NCT00905307|E6|Reported Event|Placebo|Placebo QD
437768|NCT00905307|E5|Reported Event|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
437769|NCT00905307|E4|Reported Event|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437770|NCT00905307|E3|Reported Event|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437771|NCT00905307|E2|Reported Event|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
437772|NCT00905307|E1|Reported Event|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
437773|NCT00905268|B5|Baseline|Total|Total of all reporting groups
437774|NCT00905268|B4|Baseline|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437775|NCT00905268|B3|Baseline|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437776|NCT00905268|B2|Baseline|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437777|NCT00905268|B1|Baseline|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437778|NCT00905268|P4|Participant Flow|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437779|NCT00905268|P3|Participant Flow|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437780|NCT00905268|P2|Participant Flow|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437781|NCT00905268|P1|Participant Flow|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437783|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437784|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437785|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437786|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437787|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437788|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437789|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437790|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437791|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437792|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437793|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437794|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437795|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437796|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437797|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437798|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437799|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437800|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437801|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437802|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437803|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437804|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437805|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437806|NCT00905268|E4|Reported Event|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437807|NCT00905268|E3|Reported Event|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437808|NCT00905268|E2|Reported Event|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437809|NCT00905268|E1|Reported Event|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
437810|NCT00905255|B3|Baseline|Total|Total of all reporting groups
437811|NCT00905255|B2|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
437812|NCT00905255|B1|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
437813|NCT00905255|P2|Participant Flow|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
437814|NCT00905255|P1|Participant Flow|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
437815|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437816|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437817|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437818|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
437819|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
437820|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437821|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437822|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437823|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
437824|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
437825|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437826|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
437827|NCT00905255|E2|Reported Event|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
437828|NCT00905255|E1|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
437829|NCT00905164|B3|Baseline|Total|Total of all reporting groups
437830|NCT00905164|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules,2 x 25 mg (test) dosed in second period
437831|NCT00905164|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
437832|NCT00905164|P2|Participant Flow|Topomax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
437833|NCT00905164|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topomax® Capsules, 2 x 25 mg (reference) dosed in second period
437834|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
437835|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
437836|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
437837|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
437838|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
437839|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
437840|NCT00905151|B1|Baseline|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
437841|NCT00905151|P1|Participant Flow|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
437842|NCT00905151|O1|Outcome|HIV Positive|Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function
437843|NCT00905151|E1|Reported Event|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
437844|NCT00905125|B3|Baseline|Total|Total of all reporting groups
437845|NCT00905125|B2|Baseline|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437846|NCT00905125|B1|Baseline|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437847|NCT00905125|P2|Participant Flow|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437848|NCT00905125|P1|Participant Flow|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437849|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437850|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437851|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437852|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437853|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437854|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437855|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437856|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437857|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437858|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437859|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437860|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437861|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437862|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437863|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437864|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437865|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437866|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437867|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437868|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437874|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437875|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437876|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437877|NCT00905125|E2|Reported Event|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
437878|NCT00905125|E1|Reported Event|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
437879|NCT00905034|B1|Baseline|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
437880|NCT00905034|P1|Participant Flow|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
437881|NCT00905034|O1|Outcome|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
437882|NCT00905034|E1|Reported Event|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
437883|NCT00905021|B1|Baseline|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
437884|NCT00905021|P1|Participant Flow|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
437885|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|This is a single arm study. All patients received Exemestane 25mg per day and Sunitinib 37.5 mg per day.
437886|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
437887|NCT00905021|E1|Reported Event|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
437888|NCT00904995|B3|Baseline|Total|Total of all reporting groups
437889|NCT00904995|B2|Baseline|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
437890|NCT00904995|B1|Baseline|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
437891|NCT00904995|P2|Participant Flow|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
437892|NCT00904995|P1|Participant Flow|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
437893|NCT00904995|O2|Outcome|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
437894|NCT00904995|O1|Outcome|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
437895|NCT00904995|E2|Reported Event|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
437896|NCT00904995|E1|Reported Event|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
437897|NCT00904982|B5|Baseline|Total|Total of all reporting groups
437898|NCT00904982|B4|Baseline|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
437899|NCT00904982|B3|Baseline|3 Incentive Group/Lottery|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken
437930|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437931|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437932|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437900|NCT00904982|B2|Baseline|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
437901|NCT00904982|B1|Baseline|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
437902|NCT00904982|P4|Participant Flow|4 Combined Group/Lottery and Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an"
437903|NCT00904982|P3|Participant Flow|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
437904|NCT00904982|P2|Participant Flow|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
437905|NCT00904982|P1|Participant Flow|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
437906|NCT00904982|O4|Outcome|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
437907|NCT00904982|O3|Outcome|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
437933|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437908|NCT00904982|O2|Outcome|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
437909|NCT00904982|O1|Outcome|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
437910|NCT00904982|E4|Reported Event|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
437911|NCT00904982|E3|Reported Event|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
437912|NCT00904982|E2|Reported Event|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
437913|NCT00904982|E1|Reported Event|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
437914|NCT00904969|B1|Baseline|Treated Participants|Participants in which a device placement was attempted.
437915|NCT00904969|P1|Participant Flow|Treated Participants|Participants in which a device placement was attempted.
437916|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437917|NCT00904969|O4|Outcome|Substantially or Totally Incontinent|"Defined as Will require more than three pads per day or may wet themselves two or more times per week."
437918|NCT00904969|O3|Outcome|Some Additional Protection May be Required|"Defined as Up to three pads per day may be needed or may wet themselves not more than once weekly."
437919|NCT00904969|O2|Outcome|Substantially Improved|"Defined as May have periodic leakage of small amounts but additional protection not needed."
437920|NCT00904969|O1|Outcome|Completely Dry|"Defined as No leakage."
437921|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437922|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437923|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437924|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437925|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437926|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437927|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437928|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437929|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437934|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437935|NCT00904969|O5|Outcome|>= 10 PPD|Greater than or equal to 10 Pads per Day Use
437936|NCT00904969|O4|Outcome|6-7 PPD|6-7 Pads per Day Use
437937|NCT00904969|O3|Outcome|4-5 PPD|4-5 Pads per Day Use
437938|NCT00904969|O2|Outcome|2-3 PPD|2-3 Pads per Day Use
437939|NCT00904969|O1|Outcome|0-1 PPD|0-1 Pads per Day Use
437940|NCT00904969|O6|Outcome|24 Month WCS|24 Month Visit using Worse Case Scenario
437941|NCT00904969|O5|Outcome|24 Month LOCF|24 Month Visit using Last Observation Carried Forward
437942|NCT00904969|O4|Outcome|24 Month|24 Month Follow-Up Visit
437943|NCT00904969|O3|Outcome|12 Month|12 Month Follow-Up Visit
437944|NCT00904969|O2|Outcome|6 Month|6 Month Follow-Up Visit
437945|NCT00904969|O1|Outcome|3 Month|3 Month Follow-Up Visit
437946|NCT00904969|O6|Outcome|24 Month WCS|24 Month Visit using Worse Case Scenario
437947|NCT00904969|O5|Outcome|24 Month LOCF|24 Month Visit using Last Observation Carried Forward
437948|NCT00904969|O4|Outcome|24 Month|24 Month Follow-Up Visit
437949|NCT00904969|O3|Outcome|12 Month|12 Month Follow-Up Visit
437950|NCT00904969|O2|Outcome|6 Month|6 Month Follow-Up Visit
437951|NCT00904969|O1|Outcome|3 Month|3 Month Follow-Up Visit
437952|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437953|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437954|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437955|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437956|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437957|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437958|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437959|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437960|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437961|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437962|NCT00904969|O1|Outcome|Treated Participants|Participants in which a device placement was attempted.
437963|NCT00904969|E1|Reported Event|Treated Participants|Participants in which a device placement was attempted.
437964|NCT00904943|B3|Baseline|Total|Total of all reporting groups
437965|NCT00904943|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
437966|NCT00904943|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
437967|NCT00904943|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
437968|NCT00904943|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
437969|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
437970|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
437971|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
437972|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
437973|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
437974|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
437975|NCT00904917|B5|Baseline|Total|Total of all reporting groups
437976|NCT00904917|B4|Baseline|Lecture (Children)|Children of the mother-child dyad in the lecture control group.
437977|NCT00904917|B3|Baseline|Lecture (Mothers)|Mothers of the mother-child dyad in the lecture control group.
437978|NCT00904917|B2|Baseline|Adapted PIP (Children)|Children of the mother-child dyad in the adapted PIP intervention.
437979|NCT00904917|B1|Baseline|Adapted PIP (Mothers)|Mothers of the mother-child dyad in the adapted PIP intervention.
437980|NCT00904917|P4|Participant Flow|Lecture (Children)|"Children of mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
437981|NCT00904917|P3|Participant Flow|Lecture (Mothers)|"Mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
437982|NCT00904917|P2|Participant Flow|Adapted PIP (Children)|"Children of the mother-child dyad in the adapted PIP intervention for families of children with a depressed African American Mother.~Intervention Project: Eight 1 hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies"
437983|NCT00904917|P1|Participant Flow|Adapted PIP (Mothers)|"Mothers participated in an adapted PIP for the families of children with a depressed African American mother.~Prevention Intervention Project : Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies."
437984|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
437985|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
437986|NCT00904917|O2|Outcome|Adapted PIP (Child)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
438067|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
437987|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
437988|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
437989|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression.
437990|NCT00904917|O2|Outcome|Adapted PIP (Child)|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
437991|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
437992|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
437993|NCT00904917|O1|Outcome|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
437994|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
437995|NCT00904917|O1|Outcome|Adapted PIP|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
437996|NCT00904917|E2|Reported Event|Lecture|Mothers received psychoeducation about depression.
437997|NCT00904917|E1|Reported Event|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Preventive Intervention Project.
437998|NCT00904839|B3|Baseline|Total|Total of all reporting groups
437999|NCT00904839|B2|Baseline|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438000|NCT00904839|B1|Baseline|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438001|NCT00904839|P3|Participant Flow|Bevacizumab 5 mg + mFolfox6 (Phase II)|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438002|NCT00904839|P2|Participant Flow|Nintedanib 200 mg + mFolfox6|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438003|NCT00904839|P1|Participant Flow|Nintedanib 150 mg + mFolfox6|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438004|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438005|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438006|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438007|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
438008|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438009|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438010|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438011|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438012|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
438013|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438068|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
438014|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438015|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
438016|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438017|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
438018|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438019|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438020|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438021|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438022|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438023|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438024|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438025|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438026|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438027|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438028|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438029|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438030|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438031|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438032|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438033|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
438034|NCT00904839|E2|Reported Event|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
438035|NCT00904839|E1|Reported Event|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
438036|NCT00904826|B1|Baseline|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438069|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
438037|NCT00904826|P1|Participant Flow|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438038|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438039|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438040|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438041|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438042|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438043|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438044|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438045|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438046|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438047|NCT00904826|E1|Reported Event|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
438048|NCT00904748|B1|Baseline|Entire Study Population|Includes all participants who were randomized to any treatment sequence
438049|NCT00904748|P6|Participant Flow|Sequence 6|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
438050|NCT00904748|P5|Participant Flow|Sequence 5|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
438051|NCT00904748|P4|Participant Flow|Sequence 4|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
438052|NCT00904748|P3|Participant Flow|Sequence 3|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
438053|NCT00904748|P2|Participant Flow|Sequence 2|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
438054|NCT00904748|P1|Participant Flow|Sequence 1|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
438055|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
438056|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
438057|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
438058|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
438059|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
438060|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
438061|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
438062|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
438063|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
438064|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
438065|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
438066|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
438070|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
438071|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
438072|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
438073|NCT00904748|E4|Reported Event|Formulation Unspecified|Sildenafil 100 mg tablet: formulation unspecified
438074|NCT00904748|E3|Reported Event|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
438075|NCT00904748|E2|Reported Event|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
438076|NCT00904748|E1|Reported Event|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
438077|NCT00904722|B1|Baseline|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
438078|NCT00904722|P1|Participant Flow|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
438079|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
438080|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
438081|NCT00904722|E1|Reported Event|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
438082|NCT00904670|B1|Baseline|Entire Study Population|Includes all randomized participants who received at least 1 dose of study medication.
438083|NCT00904670|P2|Participant Flow|OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.
438084|NCT00904670|P1|Participant Flow|OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)|Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
438085|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
438086|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438087|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
438088|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438089|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention period.
438090|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438091|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
438092|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438093|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
438094|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438095|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
438096|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438097|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
438098|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438099|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
438100|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
438101|NCT00904670|E3|Reported Event|DB Phase (NWP06)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60mg/day) for 1 week in either of the 2 intervention periods of the DB phase.
438102|NCT00904670|E2|Reported Event|DB Phase (Placebo)|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods of the DB phase.
438103|NCT00904670|E1|Reported Event|OL Phase (NWP06)|NWP06 oral suspension once daily optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day.
438104|NCT00904618|B1|Baseline|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
438105|NCT00904618|P1|Participant Flow|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
438106|NCT00904618|O2|Outcome|U-Method|The ‘U-Method’ is similar to the retropubic tape dissection.
438107|NCT00904618|O1|Outcome|'Hammock' Technique|The ‘Hammock’ technique is similar to the transobturator tape dissection.
438108|NCT00904618|O2|Outcome|U-Method|The U-Method is similar to the retropubic tape dissection
438109|NCT00904618|O1|Outcome|'Hammock' Technique|The 'Hammock' technique is similar to the transobturator tape dissection.
438110|NCT00904618|O1|Outcome|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
438111|NCT00904618|E1|Reported Event|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
438112|NCT00904488|B3|Baseline|Total|Total of all reporting groups
438113|NCT00904488|B2|Baseline|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438114|NCT00904488|B1|Baseline|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438115|NCT00904488|P2|Participant Flow|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438116|NCT00904488|P1|Participant Flow|Furosemide Dose Escalation|Furosemide dose escalation given either as IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours)
438117|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438118|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438119|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438120|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438121|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438122|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438123|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438124|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438125|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438126|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438127|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438128|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438129|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438130|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438131|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438132|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438133|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438134|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438135|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438136|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438137|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438138|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438139|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438140|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438141|NCT00904488|O2|Outcome|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438142|NCT00904488|O1|Outcome|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438143|NCT00904488|E2|Reported Event|IVB Loop and PO Thiazide Diuretic|Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
438144|NCT00904488|E1|Reported Event|Furosemide Dose Escalation|IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
438145|NCT00904423|B1|Baseline|Vitamin D|
438146|NCT00904423|P1|Participant Flow|Vitamin D|
438147|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
438148|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
438149|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
438150|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
438151|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
438152|NCT00904423|E1|Reported Event|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
438153|NCT00904371|B1|Baseline|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
438154|NCT00904371|P1|Participant Flow|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
438155|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438156|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438157|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438158|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438159|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438160|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438161|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438162|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438163|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438164|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438165|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438166|NCT00904371|E1|Reported Event|Micardis® 80mg MicardisPlus® 80/12.5 mg|
438167|NCT00904215|B1|Baseline|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
438168|NCT00904215|P1|Participant Flow|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
438169|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
438170|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
438171|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
438172|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
438173|NCT00904215|E1|Reported Event|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
438174|NCT00904189|B1|Baseline|1Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
438175|NCT00904189|P1|Participant Flow|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
438176|NCT00904189|O1|Outcome|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
438177|NCT00904189|O1|Outcome|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
438178|NCT00904189|E1|Reported Event|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
438179|NCT00904150|B3|Baseline|Total|Total of all reporting groups
438180|NCT00904150|B2|Baseline|2 No Migraine|Caucasian women with no personal history of migraine
438181|NCT00904150|B1|Baseline|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438182|NCT00904150|P2|Participant Flow|2 No Migraine|Caucasian women with no personal history of migraine
438183|NCT00904150|P1|Participant Flow|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438184|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
438185|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438186|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
438187|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438188|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
438189|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438190|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
438191|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438192|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
438193|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438194|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
438195|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438196|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
438197|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438198|NCT00904150|E2|Reported Event|2 No Migraine|Caucasian women with no personal history of migraine
438199|NCT00904150|E1|Reported Event|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
438200|NCT00904007|B3|Baseline|Total|Total of all reporting groups
438201|NCT00904007|B2|Baseline|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
438202|NCT00904007|B1|Baseline|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
438203|NCT00904007|P2|Participant Flow|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
438204|NCT00904007|P1|Participant Flow|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
438205|NCT00904007|O2|Outcome|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
438206|NCT00904007|O1|Outcome|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
438207|NCT00904007|E2|Reported Event|Arm 2|Control clinicians received identical educational content in an online posting with email reminders.
438208|NCT00904007|E1|Reported Event|Arm 1|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
438209|NCT00903968|B3|Baseline|Total|Total of all reporting groups
438210|NCT00903968|B2|Baseline|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
438211|NCT00903968|B1|Baseline|All Phase I Particiapnts|All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
438261|NCT00903695|B3|Baseline|Total|Total of all reporting groups
438437|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
438212|NCT00903968|P8|Participant Flow|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
438213|NCT00903968|P7|Participant Flow|Phase I Dose Level 6|Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438214|NCT00903968|P6|Participant Flow|Phase I Dose Level 5B|Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438215|NCT00903968|P5|Participant Flow|Phase I Dose Level 5|Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438216|NCT00903968|P4|Participant Flow|Phase I Dose Level 4|Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438217|NCT00903968|P3|Participant Flow|Phase I Dose Level 3|Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438218|NCT00903968|P2|Participant Flow|Phase I Dose Level 2|Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438219|NCT00903968|P1|Participant Flow|Phase I Dose Level 1|Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438220|NCT00903968|O1|Outcome|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
438221|NCT00903968|O1|Outcome|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
438222|NCT00903968|O8|Outcome|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
438223|NCT00903968|O7|Outcome|Phase I Dose Level 6|Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438224|NCT00903968|O6|Outcome|Phase I Dose Level 5B|Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438225|NCT00903968|O5|Outcome|Phase I Dose Level 5|Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438226|NCT00903968|O4|Outcome|Phase I Dose Level 4|Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438227|NCT00903968|O3|Outcome|Phase I Dose Level 3|Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438228|NCT00903968|O2|Outcome|Phase I Dose Level 2|Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438229|NCT00903968|O1|Outcome|Phase I Dose Level 1|Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438230|NCT00903968|O7|Outcome|Phase I Dose Level 6|Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438231|NCT00903968|O6|Outcome|Phase I Dose Level 5B|Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438232|NCT00903968|O5|Outcome|Phase I Dose Level 5|Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438233|NCT00903968|O4|Outcome|Phase I Dose Level 4|Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438234|NCT00903968|O3|Outcome|Phase I Dose Level 3|Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438235|NCT00903968|O2|Outcome|Phase I Dose Level 2|Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438236|NCT00903968|O1|Outcome|Phase I Dose Level 1|Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438237|NCT00903968|O1|Outcome|All Phase I Particiapnts|All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
438238|NCT00903968|O1|Outcome|All Phase I Particiapnts|All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
438239|NCT00903968|E9|Reported Event|All Phase II Participants|All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
438240|NCT00903968|E8|Reported Event|All Phase I Participants|All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
438241|NCT00903968|E7|Reported Event|Phase I Dose Level 6|Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438242|NCT00903968|E6|Reported Event|Phase I Dose Level 5B|Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438243|NCT00903968|E5|Reported Event|Phase I Dose Level 5|Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438244|NCT00903968|E4|Reported Event|Phase I Dose Level 4|Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438245|NCT00903968|E3|Reported Event|Phase I Dose Level 3|Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438246|NCT00903968|E2|Reported Event|Phase I Dose Level 2|Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438247|NCT00903968|E1|Reported Event|Phase I Dose Level 1|Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
438248|NCT00903929|B1|Baseline|Eltrombopag|Eltrombopag: dose escalation
438249|NCT00903929|P4|Participant Flow|Eltrombopag 300 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
438250|NCT00903929|P3|Participant Flow|Eltrombopag 225 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
438251|NCT00903929|P2|Participant Flow|Eltrombopag 150 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
438252|NCT00903929|P1|Participant Flow|Eltrombopag 75 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
438253|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
438254|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
438255|NCT00903929|O1|Outcome|All Participants|
438256|NCT00903929|E1|Reported Event|Eltrombopag|Eltrombopag: dose escalation
438257|NCT00903877|B1|Baseline|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
438258|NCT00903877|P1|Participant Flow|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
438259|NCT00903877|O1|Outcome|Placebo Followed by T3|Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
438260|NCT00903877|E1|Reported Event|Placebo Followed by T3|All participants receive placebo, followed by 25 mcg of T3.
438262|NCT00903695|B2|Baseline|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
438263|NCT00903695|B1|Baseline|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
438264|NCT00903695|P2|Participant Flow|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
438265|NCT00903695|P1|Participant Flow|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
438266|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438267|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438268|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438269|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438270|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438271|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438272|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438273|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438274|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438275|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438276|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438277|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438487|NCT00903383|P4|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438278|NCT00903695|O2|Outcome|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
438279|NCT00903695|O1|Outcome|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
438280|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438281|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
438282|NCT00903695|E2|Reported Event|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
438283|NCT00903695|E1|Reported Event|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
438284|NCT00903682|B3|Baseline|Total|Total of all reporting groups
438285|NCT00903682|B2|Baseline|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438286|NCT00903682|B1|Baseline|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
438287|NCT00903682|P2|Participant Flow|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438288|NCT00903682|P1|Participant Flow|Etravirine|Etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
438289|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438290|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
438291|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438292|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
438293|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438294|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
438295|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438296|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
438297|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438298|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
438299|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438300|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
438301|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438302|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
438303|NCT00903682|E2|Reported Event|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
438304|NCT00903682|E1|Reported Event|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
438305|NCT00903630|B4|Baseline|Total|Total of all reporting groups
438306|NCT00903630|B3|Baseline|Phase 2|
438307|NCT00903630|B2|Baseline|Phase 1 - Dose Level 2|
438308|NCT00903630|B1|Baseline|Phase 1 - Dose Level 1|
438309|NCT00903630|P3|Participant Flow|Phase 2 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
438310|NCT00903630|P2|Participant Flow|Phase 1 - Dose Level 2|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
438311|NCT00903630|P1|Participant Flow|Phase 1 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
438312|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin fpr recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438313|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438314|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438315|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438316|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438317|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438318|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438319|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438320|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438321|NCT00903630|E3|Reported Event|Phase 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438322|NCT00903630|E2|Reported Event|Phase 1 - Dose Level 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438323|NCT00903630|E1|Reported Event|Phase 1 - Dose Level 1|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
438324|NCT00903617|B5|Baseline|Total|Total of all reporting groups
438325|NCT00903617|B4|Baseline|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438326|NCT00903617|B3|Baseline|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438327|NCT00903617|B2|Baseline|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438328|NCT00903617|B1|Baseline|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438436|NCT00903409|P1|Participant Flow|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
438329|NCT00903617|P4|Participant Flow|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438330|NCT00903617|P3|Participant Flow|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438331|NCT00903617|P2|Participant Flow|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438332|NCT00903617|P1|Participant Flow|GSK256073 5 mg|Eligible participants received GSK256073 5 milligrams (mg) oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438333|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438334|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438335|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438336|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438337|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438338|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438339|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438340|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438341|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438342|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438343|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438344|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438345|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438346|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438347|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438348|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438349|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438350|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438351|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438352|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438353|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438354|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438355|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438356|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438357|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438358|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438359|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438360|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438361|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438362|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438363|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438364|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438365|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438366|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438367|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438368|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438369|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438370|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438371|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438372|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438373|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438374|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438375|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438376|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438377|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438378|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438379|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438380|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438381|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438382|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438383|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438384|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438385|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438386|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438387|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438388|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438389|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438390|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438391|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438392|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438393|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438394|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438395|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438396|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438397|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438398|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438399|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438400|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438401|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438402|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438403|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438404|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438405|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438406|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438407|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438408|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438409|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438410|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438411|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438412|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438413|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438414|NCT00903617|O4|Outcome|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438415|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438416|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438417|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438418|NCT00903617|O3|Outcome|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438419|NCT00903617|O2|Outcome|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438420|NCT00903617|O1|Outcome|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438421|NCT00903617|E4|Reported Event|Placebo|Eligible participants received placebo matching GSK256073 oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438422|NCT00903617|E3|Reported Event|GSK256073 150 mg|Eligible participants received GSK256073 150 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438423|NCT00903617|E2|Reported Event|GSK256073 50 mg|Eligible participants received GSK256073 50 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438424|NCT00903617|E1|Reported Event|GSK256073 5 mg|Eligible participants received GSK256073 5 mg oral tablet once daily for 60 days. Participants were provided study medication at the Baseline/randomization Visit. Study medication was self administered each morning (in a fed state) for 60 consecutive days during the out-patient visit. Participant were given a new supply of study medication approximately every 2 weeks at the out-patient visits.
438425|NCT00903448|B1|Baseline|Entire Study Population|
438426|NCT00903448|P2|Participant Flow|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
438427|NCT00903448|P1|Participant Flow|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
438428|NCT00903448|O2|Outcome|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
438429|NCT00903448|O1|Outcome|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
438430|NCT00903448|E2|Reported Event|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
438431|NCT00903448|E1|Reported Event|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
438432|NCT00903409|B3|Baseline|Total|Total of all reporting groups
438433|NCT00903409|B2|Baseline|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
438434|NCT00903409|B1|Baseline|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
438435|NCT00903409|P2|Participant Flow|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
438438|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
438439|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
438440|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
438441|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
438442|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
438443|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
438444|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
438445|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
438446|NCT00903409|E3|Reported Event|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
438447|NCT00903409|E2|Reported Event|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
438448|NCT00903409|E1|Reported Event|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
438449|NCT00903396|B5|Baseline|Total|Total of all reporting groups
438450|NCT00903396|B4|Baseline|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438451|NCT00903396|B3|Baseline|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438452|NCT00903396|B2|Baseline|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438453|NCT00903396|B1|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438454|NCT00903396|P4|Participant Flow|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438455|NCT00903396|P3|Participant Flow|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438456|NCT00903396|P2|Participant Flow|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438457|NCT00903396|P1|Participant Flow|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438458|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438459|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438460|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438461|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438462|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438463|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438464|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438465|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438466|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438467|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438468|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438469|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438470|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438471|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438472|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438473|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438474|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438475|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438476|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438477|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438478|NCT00903396|E4|Reported Event|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
438479|NCT00903396|E3|Reported Event|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
438480|NCT00903396|E2|Reported Event|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
438481|NCT00903396|E1|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
438482|NCT00903383|B5|Baseline|Total|Total of all reporting groups
438483|NCT00903383|B4|Baseline|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438484|NCT00903383|B3|Baseline|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438485|NCT00903383|B2|Baseline|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438486|NCT00903383|B1|Baseline|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438541|NCT00903344|B3|Baseline|Total|Total of all reporting groups
438488|NCT00903383|P3|Participant Flow|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438489|NCT00903383|P2|Participant Flow|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438490|NCT00903383|P1|Participant Flow|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438491|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438492|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438493|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438494|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438495|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438496|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438497|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438498|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438499|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438500|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438501|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438502|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438503|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438504|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438505|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438506|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438507|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438508|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438509|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438510|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438511|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438512|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438513|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438514|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438515|NCT00903383|E4|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
438516|NCT00903383|E3|Reported Event|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
438517|NCT00903383|E2|Reported Event|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
438518|NCT00903383|E1|Reported Event|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
438519|NCT00903370|B3|Baseline|Total|Total of all reporting groups
438520|NCT00903370|B2|Baseline|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
438521|NCT00903370|B1|Baseline|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
438522|NCT00903370|P2|Participant Flow|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
438523|NCT00903370|P1|Participant Flow|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
438524|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
438525|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
438526|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
438527|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
438528|NCT00903370|E2|Reported Event|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
438529|NCT00903370|E1|Reported Event|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
438530|NCT00903357|B1|Baseline|Entire Study Population|Includes groups randomized to receive Montelukast first and placebo first.
438531|NCT00903357|P2|Participant Flow|Placebo First, Then Montelukast|Placebo(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
438532|NCT00903357|P1|Participant Flow|Montelukast First, Then Placebo|Montelukast(4mg or 5mg) once daily in first intervention period and placebo(chewable ascorbic acid) once daily in second intervention period (after washout period).
438533|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine EDN after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
438534|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine EDN after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking Montelukast sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
438535|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine LTE4 after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
438536|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine LTE4 after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
438537|NCT00903357|O2|Outcome|Placebo Drug|Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
438538|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
438539|NCT00903357|E2|Reported Event|Placebo Drug|Placebo drug administered once daily in either first intervention period or second intervention period.
438540|NCT00903357|E1|Reported Event|Montelukast Sodium|Montelukast sodium(4mg or 5mg) administered once daily in either first intervention period or second intervention period.
438542|NCT00903344|B2|Baseline|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438543|NCT00903344|B1|Baseline|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438544|NCT00903344|P2|Participant Flow|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438545|NCT00903344|P1|Participant Flow|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438546|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438547|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438548|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438549|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438550|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438551|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438552|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438553|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438554|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438555|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438556|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438557|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438558|NCT00903344|E2|Reported Event|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
438559|NCT00903344|E1|Reported Event|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
438560|NCT00903331|B3|Baseline|Total|Total of all reporting groups
438561|NCT00903331|B2|Baseline|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
438562|NCT00903331|B1|Baseline|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
438563|NCT00903331|P2|Participant Flow|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
438564|NCT00903331|P1|Participant Flow|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
438565|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
438566|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
438567|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
438568|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
438569|NCT00903331|E2|Reported Event|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
438570|NCT00903331|E1|Reported Event|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
438571|NCT00903201|B4|Baseline|Total|Total of all reporting groups
438572|NCT00903201|B3|Baseline|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438573|NCT00903201|B2|Baseline|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438574|NCT00903201|B1|Baseline|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438575|NCT00903201|P3|Participant Flow|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438576|NCT00903201|P2|Participant Flow|SB656933 20 mg|Eligible participants received SB656933 20 milligrams (mg) tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438577|NCT00903201|P1|Participant Flow|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438578|NCT00903201|O2|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438579|NCT00903201|O1|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438580|NCT00903201|O2|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438581|NCT00903201|O1|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438582|NCT00903201|O2|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438583|NCT00903201|O1|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438869|NCT00902278|O4|Outcome|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
438584|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438585|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438586|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438587|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438588|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438589|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438590|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438591|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438592|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438593|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438594|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438595|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438596|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438597|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438598|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438599|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438600|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438601|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438602|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438603|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438604|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438605|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438606|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438607|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438608|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438609|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438610|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438611|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438612|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438613|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438614|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438615|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438616|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438617|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438618|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438619|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438620|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438621|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438622|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438623|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438624|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438625|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438626|NCT00903201|O3|Outcome|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438627|NCT00903201|O2|Outcome|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438628|NCT00903201|O1|Outcome|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438629|NCT00903201|E3|Reported Event|SB656933 50 mg|Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
438630|NCT00903201|E2|Reported Event|SB656933 20 mg|Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
438631|NCT00903201|E1|Reported Event|Placebo|Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
438632|NCT00903175|B3|Baseline|Total|Total of all reporting groups
438633|NCT00903175|B2|Baseline|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438634|NCT00903175|B1|Baseline|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438635|NCT00903175|P2|Participant Flow|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438636|NCT00903175|P1|Participant Flow|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438637|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438638|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438639|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438640|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438641|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438642|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438643|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438644|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438645|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438646|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438647|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438648|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438649|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438650|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438651|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438652|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438653|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438654|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438655|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438656|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438657|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438658|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438659|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438660|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438661|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438662|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438663|NCT00903175|E2|Reported Event|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
438664|NCT00903175|E1|Reported Event|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
438665|NCT00903162|B1|Baseline|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
438666|NCT00903162|P1|Participant Flow|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
438667|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
438668|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
438669|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
438670|NCT00903162|E1|Reported Event|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
438671|NCT00903032|B3|Baseline|Total|Total of all reporting groups
438672|NCT00903032|B2|Baseline|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
438687|NCT00903006|P2|Participant Flow|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438688|NCT00903006|P1|Participant Flow|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
438673|NCT00903032|B1|Baseline|Patient Centered Intervention|The multi-faceted patient centered intervention adapts elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, PCPs, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
438674|NCT00903032|P2|Participant Flow|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
438675|NCT00903032|P1|Participant Flow|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of re"
438676|NCT00903032|O2|Outcome|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
438677|NCT00903032|O1|Outcome|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
438678|NCT00903032|E2|Reported Event|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
438679|NCT00903032|E1|Reported Event|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education, tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
438680|NCT00903006|B5|Baseline|Total|Total of all reporting groups
438681|NCT00903006|B4|Baseline|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438682|NCT00903006|B3|Baseline|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
438683|NCT00903006|B2|Baseline|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438684|NCT00903006|B1|Baseline|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
438685|NCT00903006|P4|Participant Flow|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438686|NCT00903006|P3|Participant Flow|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
438741|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
438689|NCT00903006|O4|Outcome|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438690|NCT00903006|O3|Outcome|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
438691|NCT00903006|O2|Outcome|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438692|NCT00903006|O1|Outcome|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
438693|NCT00903006|E4|Reported Event|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438694|NCT00903006|E3|Reported Event|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
438695|NCT00903006|E2|Reported Event|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
438696|NCT00903006|E1|Reported Event|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
438697|NCT00902850|B3|Baseline|Total|Total of all reporting groups
438698|NCT00902850|B2|Baseline|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
438699|NCT00902850|B1|Baseline|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
438700|NCT00902850|P2|Participant Flow|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
438701|NCT00902850|P1|Participant Flow|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
438702|NCT00902850|O2|Outcome|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
438703|NCT00902850|O1|Outcome|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
438704|NCT00902850|E2|Reported Event|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
438705|NCT00902850|E1|Reported Event|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
438706|NCT00902746|B1|Baseline|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg, or Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
438707|NCT00902746|P1|Participant Flow|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
438708|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
438709|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
438710|NCT00902746|E1|Reported Event|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
438711|NCT00902668|B1|Baseline|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
438712|NCT00902668|P1|Participant Flow|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
438713|NCT00902668|O1|Outcome|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
438714|NCT00902668|E1|Reported Event|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
438715|NCT00902564|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438716|NCT00902564|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438717|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438718|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438719|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438720|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438721|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438722|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438723|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438724|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438725|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438726|NCT00902564|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438727|NCT00902538|B4|Baseline|Total|Total of all reporting groups
438728|NCT00902538|B3|Baseline|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438729|NCT00902538|B2|Baseline|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3
438730|NCT00902538|B1|Baseline|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
438731|NCT00902538|P6|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
438732|NCT00902538|P5|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4.
438733|NCT00902538|P4|Participant Flow|OLM 40-AML 10-HCTZ 12.5 (Responders)|Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily.
438734|NCT00902538|P3|Participant Flow|OLM 40-AML 10-HCTZ 25|Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2.
438735|NCT00902538|P2|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438736|NCT00902538|P1|Participant Flow|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day.
438737|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438738|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438739|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438740|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438860|NCT00902278|P3|Participant Flow|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
438742|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
438743|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
438744|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
438745|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
438746|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
438747|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438748|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438749|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
438750|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438751|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438752|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
438753|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438754|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438755|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
438756|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438757|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438758|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
438759|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438760|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438761|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
438762|NCT00902538|E3|Reported Event|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
438763|NCT00902538|E2|Reported Event|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
438764|NCT00902538|E1|Reported Event|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
438765|NCT00902330|B3|Baseline|Total|Total of all reporting groups
438766|NCT00902330|B2|Baseline|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
438767|NCT00902330|B1|Baseline|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
438768|NCT00902330|P2|Participant Flow|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
438861|NCT00902278|P2|Participant Flow|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
438862|NCT00902278|P1|Participant Flow|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
438863|NCT00902278|O5|Outcome|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
438864|NCT00902278|O4|Outcome|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
438769|NCT00902330|P1|Participant Flow|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
438770|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438771|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
438772|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
438773|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438774|NCT00902330|O2|Outcome|Arm II|Sham CES
438775|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438776|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438777|NCT00902330|O2|Outcome|Arm II|Sham CES
438778|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438779|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438780|NCT00902330|O2|Outcome|Arm II|Sham CES
438781|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438782|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438783|NCT00902330|O2|Outcome|Arm II|Sham CES
438784|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438785|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438786|NCT00902330|O2|Outcome|Arm II|Sham CES
438787|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438788|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438789|NCT00902330|O2|Outcome|Arm II|Sham CES
438790|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438791|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438792|NCT00902330|O2|Outcome|Arm II|Sham CES
438793|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438794|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438795|NCT00902330|O2|Outcome|Arm II|Sham CES
438796|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
438797|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
438798|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
438799|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
438800|NCT00902330|E2|Reported Event|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
438801|NCT00902330|E1|Reported Event|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
438802|NCT00902304|B4|Baseline|Total|Total of all reporting groups
438803|NCT00902304|B3|Baseline|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438804|NCT00902304|B2|Baseline|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438805|NCT00902304|B1|Baseline|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438806|NCT00902304|P3|Participant Flow|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438807|NCT00902304|P2|Participant Flow|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438808|NCT00902304|P1|Participant Flow|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438809|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438810|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438811|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438812|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438813|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438814|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438815|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438816|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438817|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438818|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438819|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438820|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438821|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438865|NCT00902278|O3|Outcome|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
438866|NCT00902278|O2|Outcome|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
438822|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438823|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438824|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438825|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438826|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438827|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438828|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438829|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438830|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438831|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438832|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438833|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438834|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438835|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438836|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438867|NCT00902278|O1|Outcome|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
438868|NCT00902278|O5|Outcome|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
438933|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438837|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438838|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438839|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438840|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438841|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438842|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438843|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438844|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438845|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438846|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438847|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438848|NCT00902304|E4|Reported Event|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438849|NCT00902304|E3|Reported Event|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
438850|NCT00902304|E2|Reported Event|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
438851|NCT00902304|E1|Reported Event|Pre-randomization|Pre-randomization
438852|NCT00902278|B6|Baseline|Total|Total of all reporting groups
438853|NCT00902278|B5|Baseline|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
438854|NCT00902278|B4|Baseline|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
438855|NCT00902278|B3|Baseline|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
438856|NCT00902278|B2|Baseline|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
438857|NCT00902278|B1|Baseline|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
438858|NCT00902278|P5|Participant Flow|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
438859|NCT00902278|P4|Participant Flow|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
438870|NCT00902278|O3|Outcome|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
438871|NCT00902278|O2|Outcome|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
438872|NCT00902278|O1|Outcome|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
438873|NCT00902278|E5|Reported Event|Afluria|Afluria: one 0.5-mL dose via intramuscular injection
438874|NCT00902278|E4|Reported Event|Fluarix|Fluarix: one 0.5-mL dose via intramuscular injection
438875|NCT00902278|E3|Reported Event|Fluzone|Fluzone: one 0.5-mL dose via intramuscular injection
438876|NCT00902278|E2|Reported Event|Fluvirin|Fluvirin: one 0.5-mL dose via intramuscular injection
438877|NCT00902278|E1|Reported Event|Flulaval|Flulaval: one 0.5-mL dose via intramuscular injection
438878|NCT00902265|B1|Baseline|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438879|NCT00902265|P1|Participant Flow|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438880|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438881|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438882|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438883|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438884|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438885|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438886|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438887|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438888|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438889|NCT00902265|E1|Reported Event|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
438890|NCT00902226|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438891|NCT00902226|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438892|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438893|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438894|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438895|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438896|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438897|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438898|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438899|NCT00902226|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
438900|NCT00902174|B3|Baseline|Total|Total of all reporting groups
438901|NCT00902174|B2|Baseline|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
438902|NCT00902174|B1|Baseline|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
438903|NCT00902174|P2|Participant Flow|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
438904|NCT00902174|P1|Participant Flow|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
438905|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
438906|NCT00902174|O1|Outcome|Imatinib 400 mg|imatinib mesylate 400 mg once daily
438907|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
438908|NCT00902174|O1|Outcome|Imatinib 200 mg|imatinib mesylate 200 mg once daily
438909|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438910|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438911|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438912|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438913|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438914|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438915|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438916|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438917|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438918|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438919|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438920|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438921|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438922|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438923|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438924|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438925|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438926|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438927|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438928|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438929|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438930|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438931|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
438932|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
438940|NCT00902161|B2|Baseline|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438941|NCT00902161|B1|Baseline|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438942|NCT00902161|P3|Participant Flow|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week run-on before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranol titration through Visit 8 clamp procedures).
438943|NCT00902161|P2|Participant Flow|Propanolol + Placebo / Propanolol + MK0893|After a 4 week wash-out period with a 4-week propanolol run-on, MK0893-matched placebo was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8) while continuing on propanolol.
438944|NCT00902161|P1|Participant Flow|Propanolol + MK0893 / Propanolol + Placebo|After a 4 week wash-out period with a 4-week propanolol run-on, single dose MK0893 was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8) while continuing on propanolol.
438945|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
438946|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438947|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438948|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
438949|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438950|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438951|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438952|NCT00902161|O1|Outcome|MK0893|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438953|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438954|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438955|NCT00902161|E3|Reported Event|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
438956|NCT00902161|E2|Reported Event|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438957|NCT00902161|E1|Reported Event|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
438958|NCT00901901|B3|Baseline|Total|Total of all reporting groups
438959|NCT00901901|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438960|NCT00901901|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438961|NCT00901901|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438962|NCT00901901|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438963|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438964|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438965|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438966|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438967|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438968|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438969|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438970|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438971|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438972|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438973|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438974|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438975|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438976|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438977|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438978|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438979|NCT00901901|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
438980|NCT00901901|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
438981|NCT00901628|B3|Baseline|Total|Total of all reporting groups
438982|NCT00901628|B2|Baseline|No Injection Group|usual postoperative care without periarticular injection
438983|NCT00901628|B1|Baseline|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438984|NCT00901628|P2|Participant Flow|No Injection Group|usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection
438985|NCT00901628|P1|Participant Flow|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438986|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
438987|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438988|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
438989|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438990|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
438991|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438992|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
438993|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438994|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
438995|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438996|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
438997|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
438998|NCT00901628|E2|Reported Event|No Injection Group|usual postoperative care without periarticular injection
438999|NCT00901628|E1|Reported Event|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
439000|NCT00901576|B7|Baseline|Total|Total of all reporting groups
439001|NCT00901576|B6|Baseline|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
439002|NCT00901576|B5|Baseline|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
439003|NCT00901576|B4|Baseline|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
439004|NCT00901576|B3|Baseline|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
439005|NCT00901576|B2|Baseline|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
439006|NCT00901576|B1|Baseline|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
439007|NCT00901576|P6|Participant Flow|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
439008|NCT00901576|P5|Participant Flow|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
439074|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439009|NCT00901576|P4|Participant Flow|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
439010|NCT00901576|P3|Participant Flow|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
439011|NCT00901576|P2|Participant Flow|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
439012|NCT00901576|P1|Participant Flow|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
439013|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439014|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
439015|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439016|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
439017|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439018|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
439019|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439020|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
439021|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439022|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
439023|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439024|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
439025|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439026|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
439027|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439028|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
439029|NCT00901576|E3|Reported Event|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
439030|NCT00901576|E2|Reported Event|Concerta Alone|Single 36 mg dose of extended-release methylphenidate HCl
439031|NCT00901576|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release guanfacine HCl
439032|NCT00901459|B1|Baseline|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
439033|NCT00901459|P1|Participant Flow|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
439034|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
439035|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
439036|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
439037|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus
439038|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex
439039|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus
439040|NCT00901459|E3|Reported Event|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
439041|NCT00901459|E2|Reported Event|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
439042|NCT00901459|E1|Reported Event|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
439043|NCT00901342|B1|Baseline|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
439044|NCT00901342|P1|Participant Flow|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
439045|NCT00901342|O1|Outcome|Sipuleucel-T|All subjects who received ≥ one sipuleucel-T infusion
439046|NCT00901342|E1|Reported Event|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
439047|NCT00901316|B3|Baseline|Total|Total of all reporting groups
439048|NCT00901316|B2|Baseline|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
439049|NCT00901316|B1|Baseline|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
439050|NCT00901316|P2|Participant Flow|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
439051|NCT00901316|P1|Participant Flow|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
439052|NCT00901316|O2|Outcome|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
439053|NCT00901316|O1|Outcome|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
439054|NCT00901316|E2|Reported Event|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
439055|NCT00901316|E1|Reported Event|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
439056|NCT00901225|B1|Baseline|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439057|NCT00901225|P1|Participant Flow|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439058|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439059|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439060|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439061|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439062|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439063|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439064|NCT00901225|E1|Reported Event|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
439065|NCT00901186|B3|Baseline|Total|Total of all reporting groups
439066|NCT00901186|B2|Baseline|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439067|NCT00901186|B1|Baseline|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439068|NCT00901186|P2|Participant Flow|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439069|NCT00901186|P1|Participant Flow|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439070|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439071|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439072|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439073|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439075|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439076|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439077|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439078|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439079|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439080|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439081|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439082|NCT00901186|E2|Reported Event|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
439083|NCT00901186|E1|Reported Event|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
439084|NCT00901017|B1|Baseline|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
439085|NCT00901017|P1|Participant Flow|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
439086|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
439087|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
439088|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
439089|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
439090|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
439091|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
439092|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
439093|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
439094|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
439095|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
439096|NCT00901017|E2|Reported Event|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
439097|NCT00901017|E1|Reported Event|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
439098|NCT00900822|B1|Baseline|Straumann Bone Ceramic|Synthetic bone graft material
439099|NCT00900822|P1|Participant Flow|Straumann BoneCeramic|Synthetic bone graft material
439100|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
439101|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
439102|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
439103|NCT00900822|O1|Outcome|Straumann BoneCeramic|Synthetic bone graft material
439104|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
439105|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
439106|NCT00900822|E2|Reported Event|BioOss|Xenograft bone graft material
439107|NCT00900822|E1|Reported Event|Straumann Bone Ceramic|Synthetic bone graft material
439108|NCT00900796|B1|Baseline|Anti-tumor Necrosis Factor Agents (Evaluable Population)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis.
439109|NCT00900796|P1|Participant Flow|Anti-tumor Necrosis Factor Agents|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
439110|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
439111|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
439112|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
439113|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
439114|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
439115|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
439116|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
439117|NCT00900796|E1|Reported Event|Anti-tumor Necrosis Factor Agents|Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
439118|NCT00900757|B1|Baseline|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439119|NCT00900757|P1|Participant Flow|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439120|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439121|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439122|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439123|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439173|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439174|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439124|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439125|NCT00900757|E1|Reported Event|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
439126|NCT00900731|B3|Baseline|Total|Total of all reporting groups
439127|NCT00900731|B2|Baseline|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439128|NCT00900731|B1|Baseline|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439129|NCT00900731|P2|Participant Flow|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439130|NCT00900731|P1|Participant Flow|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439131|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439132|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439133|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439134|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439135|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439136|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439137|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439138|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439139|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439140|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439141|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439142|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439143|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439223|NCT00900146|B6|Baseline|Total|Total of all reporting groups
439144|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439145|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439146|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439147|NCT00900731|E2|Reported Event|Tiotropium 18 μg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439148|NCT00900731|E1|Reported Event|Indacaterol 150 μg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
439149|NCT00900666|B3|Baseline|Total|Total of all reporting groups
439150|NCT00900666|B2|Baseline|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
439151|NCT00900666|B1|Baseline|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
439152|NCT00900666|P2|Participant Flow|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
439153|NCT00900666|P1|Participant Flow|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
439154|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
439155|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
439156|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
439157|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
439158|NCT00900666|E2|Reported Event|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
439159|NCT00900666|E1|Reported Event|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
439160|NCT00900627|B7|Baseline|Total|Total of all reporting groups
439161|NCT00900627|B6|Baseline|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439162|NCT00900627|B5|Baseline|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439163|NCT00900627|B4|Baseline|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439164|NCT00900627|B3|Baseline|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439165|NCT00900627|B2|Baseline|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439166|NCT00900627|B1|Baseline|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439167|NCT00900627|P6|Participant Flow|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439168|NCT00900627|P5|Participant Flow|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439169|NCT00900627|P4|Participant Flow|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439170|NCT00900627|P3|Participant Flow|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439171|NCT00900627|P2|Participant Flow|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439172|NCT00900627|P1|Participant Flow|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439175|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439176|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439177|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439178|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439179|NCT00900627|O4|Outcome|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439180|NCT00900627|O3|Outcome|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439181|NCT00900627|O2|Outcome|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439182|NCT00900627|O1|Outcome|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439183|NCT00900627|E6|Reported Event|Placebo + Paclitaxel|
439184|NCT00900627|E5|Reported Event|AZD8931 40MG bd + Paclitaxel|
439185|NCT00900627|E4|Reported Event|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439186|NCT00900627|E3|Reported Event|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
439187|NCT00900627|E2|Reported Event|AZD8931 80 mg bd|
439188|NCT00900627|E1|Reported Event|AZD8931 40 mg bd|
439189|NCT00900601|B1|Baseline|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
439190|NCT00900601|P1|Participant Flow|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
439191|NCT00900601|O1|Outcome|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
439192|NCT00900601|O1|Outcome|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
439193|NCT00900601|O1|Outcome|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
439194|NCT00900601|E1|Reported Event|Sacroliac Joint Fusion|Patients treated with sacroiliac joint fusion
439195|NCT00900237|B3|Baseline|Total|Total of all reporting groups
439196|NCT00900237|B2|Baseline|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
439197|NCT00900237|B1|Baseline|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
439198|NCT00900237|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
439199|NCT00900237|P1|Participant Flow|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
439200|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
439201|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
439202|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
439203|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
439204|NCT00900237|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
439205|NCT00900237|E1|Reported Event|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
439206|NCT00900159|B3|Baseline|Total|Total of all reporting groups
439207|NCT00900159|B2|Baseline|Placebo Then Eszopiclone|Study participants on placebo and then eszopiclone
439208|NCT00900159|B1|Baseline|Eszopiclone Then Placebo|Study participants on eszopiclone and then placebo
439209|NCT00900159|P2|Participant Flow|Placebo Then Eszopiclone|Study participants on placebo and then eszopiclone
439210|NCT00900159|P1|Participant Flow|Eszopiclone Then Placebo|Study participants on eszopiclone and then placebo
439211|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
439212|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
439213|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
439214|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
439215|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
439216|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
439217|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
439218|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
439219|NCT00900159|O2|Outcome|Placebo|Non-medicated pills
439220|NCT00900159|O1|Outcome|Eszopiclone|Medication for insomnia symptoms
439221|NCT00900159|E2|Reported Event|Placebo|"eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)~placebo: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)"
439222|NCT00900159|E1|Reported Event|Eszopiclone|eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
439224|NCT00900146|B5|Baseline|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439225|NCT00900146|B4|Baseline|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439226|NCT00900146|B3|Baseline|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439227|NCT00900146|B2|Baseline|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439228|NCT00900146|B1|Baseline|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439229|NCT00900146|P5|Participant Flow|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439230|NCT00900146|P4|Participant Flow|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439231|NCT00900146|P3|Participant Flow|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439232|NCT00900146|P2|Participant Flow|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439233|NCT00900146|P1|Participant Flow|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439349|NCT00900029|B1|Baseline|HP802-247 Vehicle|Acellular vehicle applied weekly
439350|NCT00900029|P5|Participant Flow|HP802-247 Vehicle|Acellular vehicle applied weekly applied to wound surface every week
439234|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439235|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439236|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439237|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439238|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439239|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439240|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439241|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439242|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439243|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439244|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439245|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439246|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439247|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439248|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439249|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439250|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439251|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439252|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439253|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439254|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439351|NCT00900029|P4|Participant Flow|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
439352|NCT00900029|P3|Participant Flow|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
439255|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439256|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439257|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439258|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439259|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439260|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439261|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439262|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439263|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439264|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439353|NCT00900029|P2|Participant Flow|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
439354|NCT00900029|P1|Participant Flow|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
439265|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439266|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439267|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439268|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439269|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439270|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439271|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439272|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439273|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439274|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439355|NCT00900029|O5|Outcome|HP802-247 Vehicle|Acellular vehicle applied weekly
439356|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
439357|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
439275|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439276|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439277|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439278|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439279|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439280|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439281|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439282|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439283|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439284|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439358|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
439359|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
439360|NCT00900029|O5|Outcome|HP802-247 Vehicle|Acellular vehicle applied weekly
439285|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439286|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439287|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439288|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439289|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439290|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439291|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439292|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439293|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439294|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439361|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
439362|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
439295|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439296|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439297|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439298|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439299|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439300|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439301|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439302|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439303|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439304|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439363|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
439364|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
439365|NCT00900029|E5|Reported Event|HP802-247 Vehicle|
439305|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439306|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439307|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439308|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439309|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439310|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439311|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439312|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439313|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439314|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439366|NCT00900029|E4|Reported Event|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
439367|NCT00900029|E3|Reported Event|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
439315|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439316|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439317|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439318|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439319|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439320|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439321|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439322|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439323|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439324|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439368|NCT00900029|E2|Reported Event|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
439369|NCT00900029|E1|Reported Event|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
439325|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439326|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439327|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439328|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439329|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439330|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439331|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439332|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439333|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439334|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439475|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439335|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439336|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439337|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439338|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439339|NCT00900146|E5|Reported Event|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
439340|NCT00900146|E4|Reported Event|Canakinumab 150 mg + Metformin|"Experimental: Canakinumab 150 mg + Metformin In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439341|NCT00900146|E3|Reported Event|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439342|NCT00900146|E2|Reported Event|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439343|NCT00900146|E1|Reported Event|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
439344|NCT00900029|B6|Baseline|Total|Total of all reporting groups
439345|NCT00900029|B5|Baseline|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
439346|NCT00900029|B4|Baseline|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
439347|NCT00900029|B3|Baseline|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
439348|NCT00900029|B2|Baseline|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
439370|NCT00899847|B1|Baseline|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
439371|NCT00899847|P1|Participant Flow|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
439372|NCT00899847|O1|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
439373|NCT00899847|O1|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
439374|NCT00899847|O1|Outcome|Autologous-Allogeneic Peripheral Blood Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
439375|NCT00899847|O1|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
439376|NCT00899847|O1|Outcome|Autologous-Allogeneic Peripheral Blood Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
439377|NCT00899847|O1|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
439378|NCT00899847|O1|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.
439476|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439595|NCT00898807|B2|Baseline|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
439379|NCT00899847|O1|Outcome|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
439380|NCT00899847|E1|Reported Event|Autologous-Allogeneic Hematopoietic Stem Cell Transplant|A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.
439381|NCT00899717|B3|Baseline|Total|Total of all reporting groups
439382|NCT00899717|B2|Baseline|Sham Occlusal Adjustment|
439383|NCT00899717|B1|Baseline|Real Occlusal Adjustment|
439384|NCT00899717|P2|Participant Flow|Sham Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
439385|NCT00899717|P1|Participant Flow|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
439386|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
439387|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
439388|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
439389|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
439390|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Number of patients who changed their habitual chewing side
439391|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Number of patients who changed their habitual chewing side
439392|NCT00899717|O2|Outcome|Placebo|
439393|NCT00899717|O1|Outcome|Real|
439394|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
439395|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
439396|NCT00899717|E2|Reported Event|Sham Occlusal Adjustment|
439397|NCT00899717|E1|Reported Event|Real Occlusal Adjustment|
439398|NCT00899678|B4|Baseline|Total|Total of all reporting groups
439399|NCT00899678|B3|Baseline|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439400|NCT00899678|B2|Baseline|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439401|NCT00899678|B1|Baseline|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
439402|NCT00899678|P3|Participant Flow|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439403|NCT00899678|P2|Participant Flow|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439404|NCT00899678|P1|Participant Flow|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
439405|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439406|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439407|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439408|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439477|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439409|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439410|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439411|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439412|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439413|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439414|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439415|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439416|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439417|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439418|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439419|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439420|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439421|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439422|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439423|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439424|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439478|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439677|NCT00897949|O3|Outcome|Rizatriptan 10 mg / Rizatriptan 10 mg|Rizatriptan 10 mg initially, prerandomized to rizatriptan 10 mg
439425|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439426|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439427|NCT00899678|E4|Reported Event|Overall Study|Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
439428|NCT00899678|E3|Reported Event|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439429|NCT00899678|E2|Reported Event|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
439430|NCT00899678|E1|Reported Event|Induction Period|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
439431|NCT00899600|B3|Baseline|Total|Total of all reporting groups
439432|NCT00899600|B2|Baseline|Ketamine|
439433|NCT00899600|B1|Baseline|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
439434|NCT00899600|P2|Participant Flow|Ketamine|
439435|NCT00899600|P1|Participant Flow|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
439436|NCT00899600|O2|Outcome|Ketamine|Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
439437|NCT00899600|O1|Outcome|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
439438|NCT00899600|E2|Reported Event|Ketamine|
439439|NCT00899600|E1|Reported Event|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
439440|NCT00899574|B1|Baseline|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
439441|NCT00899574|P1|Participant Flow|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
439442|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
439443|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
439444|NCT00899574|E1|Reported Event|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
439445|NCT00899470|B1|Baseline|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
439446|NCT00899470|P4|Participant Flow|S/M (Fed)> S+M (Fed)> S+M (Fasted)> S/M (Fasted)|Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted)
439447|NCT00899470|P3|Participant Flow|S+M (Fed)> S/M (Fasted) >S/M (Fed)> S+M (Fasted)|Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted)
439448|NCT00899470|P2|Participant Flow|S/M (Fasted)> S+M (Fasted)> S+M (Fed)> S/M (Fed)|Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed)
439449|NCT00899470|P1|Participant Flow|S+M (Fasted)> S/M (Fed)> S/M (Fasted)>S+M (Fed)|Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])
439450|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439451|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439452|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439453|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439454|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439455|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439456|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439457|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439458|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439459|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439460|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439461|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439462|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
439463|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439464|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
439465|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439466|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439467|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
439468|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439469|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
439470|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439471|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439472|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439473|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439474|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439591|NCT00898937|E3|Reported Event||Method of RNA recovery: unknown
439592|NCT00898937|E2|Reported Event|RNALater|Method of RNA recovery: RNALater
439479|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439480|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439481|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439482|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439483|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439484|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439485|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439486|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439487|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439488|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439489|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439490|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439491|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439492|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439493|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439494|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439495|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439496|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439497|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439498|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439499|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439500|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439501|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439502|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439503|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439504|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439505|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439506|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439507|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439508|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439509|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439510|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439593|NCT00898937|E1|Reported Event|Snap-frozen|Method of RNA recovery: Snap-frozen
439594|NCT00898807|B3|Baseline|Total|Total of all reporting groups
439511|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439512|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439513|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439514|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439515|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439516|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439517|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439518|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439519|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439520|NCT00899470|E4|Reported Event|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
439521|NCT00899470|E3|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
439522|NCT00899470|E2|Reported Event|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
439523|NCT00899470|E1|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
439524|NCT00899392|B3|Baseline|Total|Total of all reporting groups
439525|NCT00899392|B2|Baseline|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
439526|NCT00899392|B1|Baseline|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
439527|NCT00899392|P2|Participant Flow|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
439528|NCT00899392|P1|Participant Flow|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
439529|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
439530|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
439531|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
439532|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
439533|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
439534|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
439535|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
439536|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
439537|NCT00899392|E2|Reported Event|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
439538|NCT00899392|E1|Reported Event|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
439539|NCT00899379|B6|Baseline|Total|Total of all reporting groups
439540|NCT00899379|B5|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439541|NCT00899379|B4|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439542|NCT00899379|B3|Baseline|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439543|NCT00899379|B2|Baseline|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439544|NCT00899379|B1|Baseline|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439545|NCT00899379|P5|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439546|NCT00899379|P4|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439547|NCT00899379|P3|Participant Flow|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439548|NCT00899379|P2|Participant Flow|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439549|NCT00899379|P1|Participant Flow|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
439550|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
439551|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
439552|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
439553|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
439554|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
439555|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
439556|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
439557|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
439558|NCT00899379|E2|Reported Event|Placebo|All Placebo patients from all Treatment Sequences
439559|NCT00899379|E1|Reported Event|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
439560|NCT00899353|B1|Baseline|Omega 3 Supplementation|
439561|NCT00899353|P1|Participant Flow|Omega 3 Supplementation|Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.
439562|NCT00899353|O13|Outcome|Fold Change in ALC-Patient 14|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439563|NCT00899353|O12|Outcome|Fold Change in ALC-Patient 13|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439564|NCT00899353|O11|Outcome|Fold Change in ALC-Patient 11|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439565|NCT00899353|O10|Outcome|Fold Change in ALC-Patient 10|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439566|NCT00899353|O9|Outcome|Fold Change in ALC-Patient 9|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439567|NCT00899353|O8|Outcome|Fold Change in ALC-Patient 8|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439568|NCT00899353|O7|Outcome|Fold Change in ALC-Patient 7|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439569|NCT00899353|O6|Outcome|Fold Change in ALC-Patient 6|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439570|NCT00899353|O5|Outcome|Fold Change in ALC-Patient 5|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439571|NCT00899353|O4|Outcome|Fold Change in ALC-Patient 4|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439572|NCT00899353|O3|Outcome|Fold Change in ALC-Patient 3|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439573|NCT00899353|O2|Outcome|Fold Change in ALC-Patient 2|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439574|NCT00899353|O1|Outcome|Fold Change in ALC-Patient 1|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
439575|NCT00899353|O5|Outcome|Nuclear Factor Kappa B Activation Post Supplement|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
439576|NCT00899353|O4|Outcome|Nuclear Factor Kappa B Activation Following 9 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
439577|NCT00899353|O3|Outcome|Nuclear Factor Kappa B Activation Following 6 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
439578|NCT00899353|O2|Outcome|Nuclear Factor Kappa B Activation Following 3 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
439579|NCT00899353|O1|Outcome|Baseline Nuclear Factor Kappa B Activation|Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
439580|NCT00899353|E1|Reported Event|Adverse Effects|Serious adverse effects associated with omega 3 fatty acid consumption.
439581|NCT00898937|B4|Baseline|Total|Total of all reporting groups
439582|NCT00898937|B3|Baseline|Unknown|Method of RNA recovery: unknown
439583|NCT00898937|B2|Baseline|RNALater|Method of RNA recovery: RNALater
439584|NCT00898937|B1|Baseline|Snap-frozen|Method of RNA recovery: Snap-frozen
439585|NCT00898937|P3|Participant Flow||Method of RNA recovery: unknown
439586|NCT00898937|P2|Participant Flow|RNALater|"Method of RNA recovery: RNALater~For more information on RNAlater please see this link: https://www.thermofisher.com/us/en/home/brands/product-brand/rnalater.html"
439587|NCT00898937|P1|Participant Flow|Snap-frozen|"Method of RNA recovery: Snap-frozen~For more information about snap-frozen RNA recovery please see this link:~https://www.thermofisher.com/us/en/home/references/ambion-tech-support/rna-isolation/tech-notes/effect-of-freeze-thawing-of-tissue-on-rna-integrity.html"
439588|NCT00898937|O3|Outcome|Unknown|Method of RNA recovery: unknown
439589|NCT00898937|O2|Outcome|RNALater|Method of RNA recovery: RNALater
439590|NCT00898937|O1|Outcome|Snap-frozen|Method of RNA recovery: Snap-frozen
439596|NCT00898807|B1|Baseline|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
439597|NCT00898807|P2|Participant Flow|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
439598|NCT00898807|P1|Participant Flow|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
439599|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
439600|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
439601|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
439602|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
439603|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
439604|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
439605|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
439606|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
439607|NCT00898807|E2|Reported Event|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
439608|NCT00898807|E1|Reported Event|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
439609|NCT00898677|B5|Baseline|Total|Total of all reporting groups
439610|NCT00898677|B4|Baseline|Placebo|"Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
439611|NCT00898677|B3|Baseline|Sumatriptan 100 mg|"Sumatriptan 100 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
439612|NCT00898677|B2|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
439613|NCT00898677|B1|Baseline|Rizatriptan 5 mg|"Rizatriptan 5 mg orally once for treatment of single migraine attack.~Baseline measure Participants reported are those participants that recieved study treatment."
439614|NCT00898677|P4|Participant Flow|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
439615|NCT00898677|P3|Participant Flow|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
439616|NCT00898677|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439617|NCT00898677|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439618|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
439619|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
439620|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439621|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439622|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
439623|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
439624|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439625|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439626|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
439627|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
439628|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439629|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439630|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
439631|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
439632|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439633|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439634|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
439635|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
439636|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439637|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439638|NCT00898677|E4|Reported Event|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
439639|NCT00898677|E3|Reported Event|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
439640|NCT00898677|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439641|NCT00898677|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439642|NCT00898560|B1|Baseline|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
439643|NCT00898560|P1|Participant Flow|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
439644|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
439645|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
439646|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
439647|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
439648|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
439649|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
439650|NCT00898560|E2|Reported Event|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
439651|NCT00898560|E1|Reported Event|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
439652|NCT00898443|B3|Baseline|Total|Total of all reporting groups
439653|NCT00898443|B2|Baseline|Epidural Anesthetic Group|This is the experimental group for this study.
439654|NCT00898443|B1|Baseline|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
439655|NCT00898443|P2|Participant Flow|Epidural Anesthetic Group|This is the experimental group for this study.
439656|NCT00898443|P1|Participant Flow|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
439657|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
439658|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
439659|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
439660|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
439661|NCT00898443|E2|Reported Event|Epidural Anesthetic Group|This is the experimental group for this study.
439662|NCT00898443|E1|Reported Event|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
439663|NCT00898222|B1|Baseline|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
439664|NCT00898222|P1|Participant Flow|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
439665|NCT00898222|O1|Outcome|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
439666|NCT00898222|E1|Reported Event|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
439667|NCT00897949|B4|Baseline|Total|Total of all reporting groups
439668|NCT00897949|B3|Baseline|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
439669|NCT00897949|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439670|NCT00897949|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439671|NCT00897949|P3|Participant Flow|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
439672|NCT00897949|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439673|NCT00897949|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439674|NCT00897949|O6|Outcome|Placebo / Rizatriptan 10 mg|Placebo initially, prerandomized to rizatriptan 10 mg
439675|NCT00897949|O5|Outcome|Placebo / Rizatriptan 5 mg|Placebo initially, prerandomized to rizatriptan 5 mg
439676|NCT00897949|O4|Outcome|Rizatriptan 10 mg / Placebo|Rizatriptan 10 mg initially, prerandomized to placebo
439678|NCT00897949|O2|Outcome|Rizatriptan 5 mg / Placebo|Rizatriptan 5 mg initially, prerandomized to placebo
439679|NCT00897949|O1|Outcome|Rizatriptan 5 mg / Rizatriptan 5 mg|Rizatriptan 5 mg initially, prerandomized to rizatriptan 5 mg
439680|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
439681|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439682|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439683|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
439684|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439685|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439686|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
439687|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439688|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439689|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
439690|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439691|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439692|NCT00897949|E3|Reported Event|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
439693|NCT00897949|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
439694|NCT00897949|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439695|NCT00897910|B1|Baseline|Collection of Circulating Blood and Bone Marrow.|
439696|NCT00897910|P1|Participant Flow|Collection of Circulating Blood and Bone Marrow.|
439697|NCT00897910|O1|Outcome|Collection of Blood and Bone Marrow.|
439698|NCT00897910|E1|Reported Event|Collection of Circulating Blood and Bone Marrow.|
439699|NCT00897897|B1|Baseline|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
439700|NCT00897897|P1|Participant Flow|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
439701|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
439702|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
439703|NCT00897897|E1|Reported Event|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
439704|NCT00897715|B3|Baseline|Total|Total of all reporting groups
439705|NCT00897715|B2|Baseline|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
439706|NCT00897715|B1|Baseline|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
439707|NCT00897715|P2|Participant Flow|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
439708|NCT00897715|P1|Participant Flow|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
439709|NCT00897715|O2|Outcome|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
439710|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
439711|NCT00897715|O2|Outcome|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
439712|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
439713|NCT00897715|E2|Reported Event|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
439714|NCT00897715|E1|Reported Event|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
439715|NCT00897676|B1|Baseline|Subject Population|9 subjects were randomized to the vehicle first arm and the next day they were switched to exendin- (9-39). 7 subjects were randomized to the exendin-(9-39) first arm and the next day they were switched to vehicle. All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
439747|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439992|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
439993|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
439716|NCT00897676|P2|Participant Flow|Exendin-(9-39) First Then Vehicle|"An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). At time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. The following day, at time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, glucagon-like peptide-(GLP-1) , and glucagon will be measured every 30 minutes.~Exendin-(9-39): 100-500pmol/kg/min"
439717|NCT00897676|P1|Participant Flow|Vehicle First Then Exendin-(9-39)|"An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). At time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. The following day, at time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, glucagon-like peptide-(GLP-1) , and glucagon will be measured every 30 minutes.~Vehicle: (0.9% NaCl)"
439718|NCT00897676|O2|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to time 360 min~Exendin-(9-39)"
439719|NCT00897676|O1|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 min to time 360 min~Vehicle"
439720|NCT00897676|O2|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 to time 360 min~Exendin-(9-39)"
439721|NCT00897676|O1|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 to time 360 min~Vehicle: (0.9% NaCl)"
439722|NCT00897676|O2|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 to time 360 min~Exendin-(9-39)"
439723|NCT00897676|O1|Outcome|Vehicle|"Subjects receive an infusion of vehicle( 0.9%NaCl) intravenously from time 0 to time 360 min~Vehicle: (0.9% NaCl)"
439724|NCT00897676|O2|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to time 360 min~Exendin-(9-39)"
439725|NCT00897676|O1|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 min to time 360 min~Vehicle: (0.9% NaCl)"
439726|NCT00897676|O2|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously from time 0 to time 360 min at a dose of 100-500 pmol/kg/min~Exendin-(9-39)"
439727|NCT00897676|O1|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 to time 360 min~Vehicle: (0.9% NaCl)"
439728|NCT00897676|O2|Outcome|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to 360 min~Exendin-(9-39)"
439729|NCT00897676|O1|Outcome|Vehicle|"Subjects received an infusion of vehicle( 0.9%NaCl) intravenously from time 0 min to 360 min~Vehicle: (0.9% NaCl)"
439730|NCT00897676|E2|Reported Event|Exendin-(9-39)|"Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to time 360 min~Exendin-(9-39)"
439731|NCT00897676|E1|Reported Event|Vehicle|"Subjects received an infusion of vehicle (0.9% NaCl) intravenously from time 0 min to time 360 min~Vehicle: (0.9% NaCl)"
439732|NCT00897390|B1|Baseline|All Enrolled and Treated Participants|
439733|NCT00897390|P1|Participant Flow|All Treated Participants|Participants were assigned to 1 of 4 treatment sequences (A-D-B-C, B-A-C-D, C-B-D-A, D-C-A-B). Treatment A=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fasted; Treatment B=fixed-dose combination (FDC) tablet of 2.5-mg saxagliptin/1000-mg metformin immediate release (IR), fasted; Treatment C=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fed; Treatment D=FDC tablet of 2.5-mg saxagliptin/1000-mg metformin IR, fed. The washout between each dose was at least 7 days.
439734|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439735|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439736|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439737|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439738|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439739|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439740|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439741|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439742|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439743|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439744|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439745|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439746|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439748|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439749|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439750|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439751|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439752|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439753|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439754|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439755|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439756|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439757|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439758|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439759|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439760|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439761|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439762|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439763|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439764|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439765|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439766|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439767|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439768|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439769|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439770|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439771|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439772|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439773|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439774|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439775|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439776|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439777|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439778|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439779|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439979|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439780|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439781|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439782|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439783|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439784|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439785|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439786|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439787|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439788|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439789|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439790|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439791|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439792|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439793|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439794|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439795|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439796|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439797|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439798|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439799|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439800|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439801|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439802|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439803|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439804|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439805|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439806|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439807|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439808|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439809|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439810|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
439811|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
439980|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439812|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439813|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
439814|NCT00897390|E5|Reported Event|Not Dosed|58 participants were enrolled in the study; 34 participants were not dosed (23 no longer met study criteria, 4 withdrew consent, and 7 for other reasons).
439815|NCT00897390|E4|Reported Event|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal.
439816|NCT00897390|E3|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal.
439817|NCT00897390|E2|Reported Event|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
439818|NCT00897390|E1|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions.
439819|NCT00897104|B4|Baseline|Total|Total of all reporting groups
439820|NCT00897104|B3|Baseline|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439821|NCT00897104|B2|Baseline|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439822|NCT00897104|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439823|NCT00897104|P3|Participant Flow|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439824|NCT00897104|P2|Participant Flow|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439825|NCT00897104|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439826|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439827|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439828|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439829|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439830|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439831|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439832|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439833|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439834|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439835|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439836|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439837|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439838|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439839|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439840|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439841|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439842|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439843|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439844|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439845|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439846|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439847|NCT00897104|E3|Reported Event|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
439848|NCT00897104|E2|Reported Event|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
439849|NCT00897104|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
439850|NCT00896779|B3|Baseline|Total|Total of all reporting groups
439851|NCT00896779|B2|Baseline|Ranibizumab Group 2|Group 2: 6 monthly injecions of 0.5mg then prn
439852|NCT00896779|B1|Baseline|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
439853|NCT00896779|P2|Participant Flow|Ranibizumab Group 2|Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
439854|NCT00896779|P1|Participant Flow|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
439855|NCT00896779|O2|Outcome|Ranibizumab Group 2|Group 2: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
439856|NCT00896779|O1|Outcome|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
439857|NCT00896779|E2|Reported Event|Ranibizumab Group 2|Group 2: 6 monthly injections of 0.5 mg then prn
439858|NCT00896779|E1|Reported Event|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
439981|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439982|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439859|NCT00896649|B1|Baseline|Positron Emission Mammography (PEM), Mammography, Questionaire|"questionnaire administration digital mammography positron emission mammography~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~digital mammography: standard screening mammogram~positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
439860|NCT00896649|P1|Participant Flow|Single Arm Positron Emission Mamm, Mammogram and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
439861|NCT00896649|O1|Outcome|Single Arm Positron Emission Mammo, Mammogram & Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
439862|NCT00896649|O1|Outcome|Single Arm Positron Emission Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
439863|NCT00896649|E1|Reported Event|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
439864|NCT00896454|B1|Baseline|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439865|NCT00896454|P1|Participant Flow|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439866|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439867|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439868|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439869|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439870|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439871|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439872|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439873|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439874|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439875|NCT00896454|E1|Reported Event|Denosumab 120 mg Q4W|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
439876|NCT00896441|B3|Baseline|Total|Total of all reporting groups
439877|NCT00896441|B2|Baseline|Healthy Controls|Participants with no history of psychiatric illness
439878|NCT00896441|B1|Baseline|Depressed|Depressed individuals
439879|NCT00896441|P2|Participant Flow|Healthy Controls|Participants with no history of psychiatric illness
439880|NCT00896441|P1|Participant Flow|Depressed|Depressed individuals
439881|NCT00896441|O1|Outcome|Depressed|Depressed individuals
439882|NCT00896441|O1|Outcome|Depressed|Depressed individuals
439883|NCT00896441|O1|Outcome|Depressed|Depressed individuals
439884|NCT00896441|E2|Reported Event|Healthy Controls|Participants with no history of psychiatric illness
439885|NCT00896441|E1|Reported Event|Depressed|Depressed individuals
439886|NCT00896389|B1|Baseline|Salt-loading and Thiazide Diuretic (HCTZ)|"Salt loading: Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 L of 0.9% NaCl (sodium chloride) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.~Hydrochlorothiazide (HCTZ): After overnight fasting and having their height, weight, and BP measured, subjects are given 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure, blood and urine will be collected on both day 1 and day 8. After a wash-out period, the subjects will repeat the HCTZ intervention, taking 25 mg HCTZ instead."
439887|NCT00896389|P1|Participant Flow|Salt-loading and Thiazide Diuretics (HCTZ)|Salt loading: 2 liters (L) of 0.9% sodium chloride (NaCl). HCTZ:12.5 or 25 mg of HCTZ for 1 week
439888|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439983|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440396|NCT00895622|P2|Participant Flow|Intermidiate Risk|54 Gy radiotherapy
439889|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439890|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439891|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439892|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439893|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439894|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439895|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439896|NCT00896389|O1|Outcome|rs35929607 SNP|"SNP rs35929607, located in an intron of STK39 gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439897|NCT00896389|O1|Outcome|rs35929607 SNP|"Single nucleotide polymorphism (SNP) rs35929607, located in an intron of serine threonine kinase 39 (STK39) gene, is associated with blood pressure in the Amish population.~This SNP, rs35929607, has 2 alleles, A and G. Allele G is found less frequently and has an allele frequency of approximately 0.2-0.4 in populations studied thus far. We genotyped all participants of this study and determine if they are homozygous for the G allele, i.e., have the GG genotype, or are heterozygous (AG genotype), or are homozygous for the A allele and have the AA genotype."
439898|NCT00896389|E2|Reported Event|HCTZ|After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ.
439899|NCT00896389|E1|Reported Event|Salt Loading|Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 L of 0.9% NaCl (sodium chloride) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion.
439900|NCT00896363|B4|Baseline|Total|Total of all reporting groups
439901|NCT00896363|B3|Baseline|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439902|NCT00896363|B2|Baseline|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439903|NCT00896363|B1|Baseline|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
440397|NCT00895622|P1|Participant Flow|Low Risk|No treatment given
439904|NCT00896363|P3|Participant Flow|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439905|NCT00896363|P2|Participant Flow|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 milligram (mg) immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards
439906|NCT00896363|P1|Participant Flow|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet in the morning (AM) and one taken between 11 to 13 hours after the AM dose in the evening (PM) for 6 weeks.
439907|NCT00896363|O2|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439908|NCT00896363|O1|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439909|NCT00896363|O2|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439910|NCT00896363|O1|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439911|NCT00896363|O2|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439912|NCT00896363|O1|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439913|NCT00896363|O2|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439914|NCT00896363|O1|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439915|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439916|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439917|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks
440398|NCT00895622|O3|Outcome|Central Review: Anaplastic|
439918|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439919|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439920|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439921|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439922|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439923|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439924|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439925|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439926|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439927|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439928|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439929|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439930|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439931|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439932|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439984|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439985|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439986|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439987|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439933|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439934|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439935|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439936|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439937|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439938|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439939|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439940|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439941|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439942|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439943|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439944|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439945|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439946|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439947|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439988|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439989|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439990|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439991|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439948|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439949|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439950|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439951|NCT00896363|O3|Outcome|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439952|NCT00896363|O2|Outcome|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) from Day 2 onwards.
439953|NCT00896363|O1|Outcome|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439954|NCT00896363|E3|Reported Event|GSK163090 3 mg|Participants were randomized to the high dose arm to receive oral dose of GSK163090 up to 3 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1, (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg) on Day 2 to Day 3, (AM- GSK163090 1 mg and PM- GSK163090 1 mg) on Day 4 to Day 5 and continued (AM- GSK163090 1.5 mg and PM- GSK163090 1.5 mg) from Day 6 onwards.
439955|NCT00896363|E2|Reported Event|GSK163090 1 mg|Participants were randomized to the low dose arm to receive oral dose of GSK163090 up to 1 mg immediate release tablet twice a day, with one tablet in the AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks. Daily dosage was provided according to the titration schedule, where the participants received (AM -matching placebo tablet, PM- GSK163090 0.5 mg ) on Day 1 and continued (AM- GSK163090 0.5 mg and PM- GSK163090 0.5 mg).from Day 2 onwards.
439956|NCT00896363|E1|Reported Event|Placebo|Participants were randomized to receive oral dose of matching placebo tablet to GSK163090 twice a day, with one tablet AM and one taken between 11 to 13 hours after the AM dose in the PM for 6 weeks.
439957|NCT00896337|B1|Baseline|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
439958|NCT00896337|P1|Participant Flow|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
439959|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439960|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439961|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439962|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439963|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439964|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439965|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439966|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439967|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439968|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
439969|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
439970|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439971|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439972|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439973|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439974|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439975|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439976|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439977|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439978|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439994|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
439995|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
439996|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
439997|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439998|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
439999|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440000|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440001|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440002|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440003|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440004|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440005|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440006|NCT00896337|O1|Outcome|Epis Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
440007|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440008|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440009|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440010|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440011|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440012|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440013|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440014|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440015|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440016|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440017|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440018|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440019|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440020|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440021|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440022|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
440023|NCT00896337|E1|Reported Event|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
440024|NCT00896233|B1|Baseline|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
440025|NCT00896233|P1|Participant Flow|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
440026|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
440027|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
440028|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
440029|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
440030|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
440031|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
440032|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
440033|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
440034|NCT00896233|E1|Reported Event|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
440035|NCT00896168|B3|Baseline|Total|Total of all reporting groups
440036|NCT00896168|B2|Baseline|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440037|NCT00896168|B1|Baseline|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440038|NCT00896168|P2|Participant Flow|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440076|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440039|NCT00896168|P1|Participant Flow|Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA])|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440040|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440041|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440042|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440043|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440044|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440045|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440046|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440047|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440048|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440049|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440050|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440051|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440052|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440053|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440054|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440055|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440056|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440077|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440057|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440058|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440059|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440060|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440061|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440062|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440063|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440064|NCT00896168|E2|Reported Event|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
440065|NCT00896168|E1|Reported Event|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
440066|NCT00896064|B3|Baseline|Total|Total of all reporting groups
440067|NCT00896064|B2|Baseline|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440068|NCT00896064|B1|Baseline|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440069|NCT00896064|P2|Participant Flow|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440070|NCT00896064|P1|Participant Flow|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440071|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440072|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440073|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440074|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440075|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440173|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440174|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440078|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440079|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440080|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440081|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440082|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440083|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440084|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440085|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440086|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440087|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440088|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440089|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440090|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440091|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440092|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440093|NCT00896064|O2|Outcome|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440094|NCT00896064|O1|Outcome|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440095|NCT00896064|E2|Reported Event|GSK2189242A Formulation 2 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 2 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 2 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440096|NCT00896064|E1|Reported Event|GSK2189242A Formulation 1 Group|Healthy male and female subjects, aged between 18 and 41 years old, who were previously primed with the GSK2189242A Formulation 1 vaccine during the 111651 study, received a booster dose of the GSK2189242A Formulation 1 vaccine, administered via intramuscular injection into the deltoid of the non-dominant arm, at Day 0.
440097|NCT00896051|B3|Baseline|Total|Total of all reporting groups
440098|NCT00896051|B2|Baseline|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
440099|NCT00896051|B1|Baseline|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
440100|NCT00896051|P2|Participant Flow|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
440101|NCT00896051|P1|Participant Flow|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
440102|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440103|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440104|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440105|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440106|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440107|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440108|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440109|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440110|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440111|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440112|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440113|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440114|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440115|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440175|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440176|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440116|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
440117|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
440118|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
440119|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
440120|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
440121|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
440122|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
440123|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440124|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for rtv provided in the table below are at Week 2.
440125|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440126|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
440127|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440128|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
440129|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440130|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
440131|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440132|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
440133|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440177|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440399|NCT00895622|O2|Outcome|Central Review: Atypical|
440134|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
440135|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440136|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
440137|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
440138|NCT00896051|E2|Reported Event|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
440139|NCT00896051|E1|Reported Event|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
440140|NCT00896038|B3|Baseline|Total|Total of all reporting groups
440141|NCT00896038|B2|Baseline|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
440142|NCT00896038|B1|Baseline|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440143|NCT00896038|P2|Participant Flow|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
440144|NCT00896038|P1|Participant Flow|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440145|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440146|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440147|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440148|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440149|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440150|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440151|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440152|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440153|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440154|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440155|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440156|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440157|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440158|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440159|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440160|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440161|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440162|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440163|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440164|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440165|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440166|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440167|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440168|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440169|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440170|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440171|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
440172|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440178|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440179|NCT00896038|E2|Reported Event|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
440180|NCT00896038|E1|Reported Event|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
440181|NCT00896025|B1|Baseline|N-acetycylcysteine|Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous NAC infusion for a total of 72 hours.
440182|NCT00896025|P1|Participant Flow|N-acetycylcysteine|Acute liver failure population
440183|NCT00896025|O1|Outcome|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
440184|NCT00896025|E1|Reported Event|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
440185|NCT00895947|B3|Baseline|Total|Total of all reporting groups
440186|NCT00895947|B2|Baseline|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440187|NCT00895947|B1|Baseline|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440188|NCT00895947|P2|Participant Flow|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440189|NCT00895947|P1|Participant Flow|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440190|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440191|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440192|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440193|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440194|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440195|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440196|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440197|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440198|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440199|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440200|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440201|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440202|NCT00895947|E2|Reported Event|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
440203|NCT00895947|E1|Reported Event|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
440204|NCT00895934|B3|Baseline|Total|Total of all reporting groups
440205|NCT00895934|B2|Baseline|Phase 2/Selected Dose|Azacitidine 75 mg/m2 SC or IV on days 1-7, vorinostat 400 mg qd po on days 1-9, gemtuzumab ozogamicin 3 mg/m2 IV on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
440206|NCT00895934|B1|Baseline|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
440207|NCT00895934|P2|Participant Flow|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
440208|NCT00895934|P1|Participant Flow|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat orally on days 1-9, azacitidine subcutaneously (SC) or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
440209|NCT00895934|O2|Outcome|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
440210|NCT00895934|O1|Outcome|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
440211|NCT00895934|E2|Reported Event|Phase 2/Selected Dose|"Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.~Laboratory biomarker analysis: correlative studies"
440212|NCT00895934|E1|Reported Event|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: correlative studies"
440213|NCT00895895|B6|Baseline|Total|Total of all reporting groups
440214|NCT00895895|B5|Baseline|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440215|NCT00895895|B4|Baseline|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440216|NCT00895895|B3|Baseline|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440217|NCT00895895|B2|Baseline|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440218|NCT00895895|B1|Baseline|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440219|NCT00895895|P5|Participant Flow|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440220|NCT00895895|P4|Participant Flow|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440221|NCT00895895|P3|Participant Flow|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440222|NCT00895895|P2|Participant Flow|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440223|NCT00895895|P1|Participant Flow|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440224|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440225|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440226|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440227|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440400|NCT00895622|O1|Outcome|Central Review: Benign|
440401|NCT00895622|O3|Outcome|High Risk|60 Gy radiotherapy
440228|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440229|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440230|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440231|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440232|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440233|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440234|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440235|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440236|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440237|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440238|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440239|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440240|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440241|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440242|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440243|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440244|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440402|NCT00895622|O2|Outcome|Intermidiate Risk|54 Gy radiotherapy
440245|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440246|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440247|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440248|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440249|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440250|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440251|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440252|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440253|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440254|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440255|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440256|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440257|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440258|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440259|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440260|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440261|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440388|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
440262|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440263|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440264|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440265|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440266|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440267|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440268|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440269|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440270|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440271|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440272|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440273|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440274|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440275|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440276|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440277|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440278|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440403|NCT00895622|O1|Outcome|Low Risk|No treatment given
440279|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440280|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440281|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440282|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440283|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440284|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440285|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440286|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440287|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440288|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440289|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440290|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440291|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440292|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440293|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440294|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440295|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440389|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
440296|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440297|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440298|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440299|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440300|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440301|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440302|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440303|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440304|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440305|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440306|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440307|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440308|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440309|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440310|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440311|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440312|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440390|NCT00895661|E1|Reported Event|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
440313|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440314|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440315|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440316|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440317|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440318|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440319|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440320|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440321|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440322|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440323|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440324|NCT00895895|E10|Reported Event|Donepezil Period 2|Matching SAM-531 placebo capsule administered QD (morning dose) for up to 52 weeks. One encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) from Week 25 up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
440325|NCT00895895|E9|Reported Event|SAM-531 5.0 mg Period 2|SAM-531 5.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440326|NCT00895895|E8|Reported Event|SAM-531 3.0 mg Period 2|SAM-531 3.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440327|NCT00895895|E7|Reported Event|SAM-531 1.5 mg Period 2|SAM-531 1.5 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440328|NCT00895895|E6|Reported Event|SAM-531 5.0 mg Crossover Period 2|Participants who received Placebo in Period 1, beginning in Week 25 and up to Week 52 (Period 2) received SAM-531 5.0 mg capsule administered QD (morning dose) and matching encapsulated Donepezil placebo tablet administered QD (evening dose). The evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440329|NCT00895895|E5|Reported Event|Donepezil Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and 1 encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
440391|NCT00895622|B4|Baseline|Total|Total of all reporting groups
440330|NCT00895895|E4|Reported Event|SAM-531 5.0 mg Period 1|SAM-531 5.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440331|NCT00895895|E3|Reported Event|SAM-531 3.0 mg Period 1|SAM-531 3.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440332|NCT00895895|E2|Reported Event|SAM-531 1.5 mg Period 1|SAM-531 1.5 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440333|NCT00895895|E1|Reported Event|Placebo/5.0 mg Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and one encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 24 weeks (Period 1). From Week 7 the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
440334|NCT00895843|B3|Baseline|Total|Total of all reporting groups
440335|NCT00895843|B2|Baseline|Brufen Retard|
440336|NCT00895843|B1|Baseline|Conventional Ibuprofen|
440337|NCT00895843|P2|Participant Flow|Brufen Retard|
440338|NCT00895843|P1|Participant Flow|Conventional Ibuprofen|
440339|NCT00895843|O2|Outcome|Brufen Retard|
440340|NCT00895843|O1|Outcome|Conventional Ibuprofen|
440341|NCT00895843|E2|Reported Event|Brufen Retard|
440342|NCT00895843|E1|Reported Event|Conventional Ibuprofen|
440343|NCT00895830|B6|Baseline|Total|Total of all reporting groups
440344|NCT00895830|B5|Baseline|APD405 3mg Dose|
440345|NCT00895830|B4|Baseline|APD405 2mg Dose|
440346|NCT00895830|B3|Baseline|APD405 1mg Dose|
440347|NCT00895830|B2|Baseline|APD405 0.3mg Dose|
440348|NCT00895830|B1|Baseline|Placebo|
440349|NCT00895830|P5|Participant Flow|APD405 3mg Dose|
440350|NCT00895830|P4|Participant Flow|APD405 2mg Dose|
440351|NCT00895830|P3|Participant Flow|APD405 1mg Dose|
440352|NCT00895830|P2|Participant Flow|APD405 0.3mg Dose|
440353|NCT00895830|P1|Participant Flow|Placebo|
440354|NCT00895830|O5|Outcome|APD405 3mg Dose|
440355|NCT00895830|O4|Outcome|APD405 2mg Dose|
440356|NCT00895830|O3|Outcome|APD405 1mg Dose|
440357|NCT00895830|O2|Outcome|APD405 0.3mg Dose|
440358|NCT00895830|O1|Outcome|Placebo|
440359|NCT00895830|E5|Reported Event|APD405 3mg Dose|
440360|NCT00895830|E4|Reported Event|APD405 2mg Dose|
440361|NCT00895830|E3|Reported Event|APD405 1mg Dose|
440362|NCT00895830|E2|Reported Event|APD405 0.3mg Dose|
440363|NCT00895830|E1|Reported Event|Placebo|
440364|NCT00895817|B3|Baseline|Total|Total of all reporting groups
440365|NCT00895817|B2|Baseline|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
440366|NCT00895817|B1|Baseline|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
440367|NCT00895817|P2|Participant Flow|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
440368|NCT00895817|P1|Participant Flow|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
440369|NCT00895817|O2|Outcome|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
440370|NCT00895817|O1|Outcome|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
440371|NCT00895817|E2|Reported Event|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
440372|NCT00895817|E1|Reported Event|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
440373|NCT00895752|B1|Baseline|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
440374|NCT00895752|P1|Participant Flow|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
440375|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
440376|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
440377|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
440378|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
440379|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
440380|NCT00895752|O1|Outcome|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
440381|NCT00895752|O1|Outcome|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
440382|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
440383|NCT00895752|E1|Reported Event|Riluzole|"Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.~Riluzole: Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day."
440384|NCT00895661|B1|Baseline|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
440385|NCT00895661|P1|Participant Flow|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
440386|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
440387|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
440418|NCT00895583|B2|Baseline|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440419|NCT00895583|B1|Baseline|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440420|NCT00895583|P2|Participant Flow|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440421|NCT00895583|P1|Participant Flow|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440422|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440423|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440424|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440425|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440426|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440512|NCT00895453|P2|Participant Flow|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
440513|NCT00895453|P1|Participant Flow|Itraconazole|itraconazole alone
440514|NCT00895453|O3|Outcome|Classic Homeopathy|
440515|NCT00895453|O2|Outcome|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
440427|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440428|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440429|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440430|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440431|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440432|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440433|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440434|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440435|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440516|NCT00895453|O1|Outcome|Itraconazole|itraconazole alone
440436|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440437|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440438|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440439|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440440|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440441|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440442|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440443|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440444|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440569|NCT00895193|P2|Participant Flow|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440570|NCT00895193|P1|Participant Flow|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440674|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440445|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440446|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440447|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440448|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440449|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440450|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440451|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440452|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440453|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440616|NCT00895011|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
440454|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440455|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440456|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440457|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440458|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440459|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440460|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440461|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440462|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440571|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440572|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440675|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440463|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440464|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440465|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440466|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440467|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440468|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440469|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440470|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440471|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440617|NCT00895011|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
440472|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440473|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440474|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440475|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440476|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440477|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440478|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440479|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440480|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440573|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440574|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440673|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440792|NCT00894504|O6|Outcome|PTEN Loss|
440481|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440482|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440483|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440484|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440485|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440486|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440487|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440488|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440489|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440613|NCT00895011|B3|Baseline|Avanafil 200 mg|
440614|NCT00895011|B2|Baseline|Avanafil 100 mg|
440490|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440491|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440492|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440493|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440494|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440495|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440496|NCT00895583|E2|Reported Event|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440497|NCT00895583|E1|Reported Event|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
440498|NCT00895531|B3|Baseline|Total|Total of all reporting groups
440499|NCT00895531|B2|Baseline|Depodur Group|
440500|NCT00895531|B1|Baseline|Peripheral Nerve Group|
440501|NCT00895531|P2|Participant Flow|Depodur Group|
440502|NCT00895531|P1|Participant Flow|Peripheral Nerve Group|
440503|NCT00895531|O2|Outcome|Depodur Group|
440504|NCT00895531|O1|Outcome|Peripheral Nerve Group|
440505|NCT00895531|E2|Reported Event|Depodur Group|
440506|NCT00895531|E1|Reported Event|Peripheral Nerve Group|
440507|NCT00895453|B4|Baseline|Total|Total of all reporting groups
440508|NCT00895453|B3|Baseline|Classic Homeopathy|
440509|NCT00895453|B2|Baseline|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
440510|NCT00895453|B1|Baseline|Itraconazole|itraconazole alone
440517|NCT00895453|E3|Reported Event|Classic Homeopathy (CH)|"CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.~classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed): CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000."
440518|NCT00895453|E2|Reported Event|Itraconazole + Lactobacilli Agent|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)~lactobacillus gasseri: Lactobacillus vaginal tablets monthly given through 6 days"
440519|NCT00895453|E1|Reported Event|Itraconazole|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)"
440520|NCT00895310|B1|Baseline|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
440521|NCT00895310|P1|Participant Flow|Ketoconazole|"Ketoconazole 200mg PO (by mouth) TID (three times a day) + Hydrocortisone 20mg PO Qam (every morning), 10mg PO Qpm (every evening)~Ketoconazole: Ketoconazole is taken three times a day by mouth."
440522|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
440523|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
440524|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
440525|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
440526|NCT00895310|E1|Reported Event|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
440527|NCT00895284|B3|Baseline|Total|Total of all reporting groups
440528|NCT00895284|B2|Baseline|Standard|Standard hysterectomy
440529|NCT00895284|B1|Baseline|Robot|Robotic hysterectomy
440530|NCT00895284|P2|Participant Flow|Standard|Standard hysterectomy
440531|NCT00895284|P1|Participant Flow|Robot|Robotic hysterectomy
440532|NCT00895284|O2|Outcome|Standard|Standard hysterectomy
440533|NCT00895284|O1|Outcome|Robot|Robotic hysterectomy
440534|NCT00895284|E2|Reported Event|Standard|Standard hysterectomy
440535|NCT00895284|E1|Reported Event|Robot|Robotic hysterectomy
440536|NCT00895245|B1|Baseline|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo radiotherapy"
440537|NCT00895245|P1|Participant Flow|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo radiotherapy"
440538|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
440539|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
440540|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
440541|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
440542|NCT00895245|E1|Reported Event|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
440543|NCT00895232|B4|Baseline|Total|Total of all reporting groups
440544|NCT00895232|B3|Baseline|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
440545|NCT00895232|B2|Baseline|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
440546|NCT00895232|B1|Baseline|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
440547|NCT00895232|P3|Participant Flow|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
440548|NCT00895232|P2|Participant Flow|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
440549|NCT00895232|P1|Participant Flow|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
440550|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
440551|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
440552|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
440553|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
440554|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
440555|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
440556|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
440557|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
440558|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
440559|NCT00895232|E3|Reported Event|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
440560|NCT00895232|E2|Reported Event|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
440561|NCT00895232|E1|Reported Event|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
440562|NCT00895193|B5|Baseline|Total|Total of all reporting groups
440563|NCT00895193|B4|Baseline|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440564|NCT00895193|B3|Baseline|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440565|NCT00895193|B2|Baseline|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440566|NCT00895193|B1|Baseline|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440567|NCT00895193|P4|Participant Flow|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440568|NCT00895193|P3|Participant Flow|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440615|NCT00895011|B1|Baseline|Placebo|
440575|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440576|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440577|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440578|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440579|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440580|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440581|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440582|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440583|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440584|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440585|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440586|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440587|NCT00895193|E4|Reported Event|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440588|NCT00895193|E3|Reported Event|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440589|NCT00895193|E2|Reported Event|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440590|NCT00895193|E1|Reported Event|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
440591|NCT00895180|B3|Baseline|Total|Total of all reporting groups
440592|NCT00895180|B2|Baseline|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440593|NCT00895180|B1|Baseline|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440594|NCT00895180|P2|Participant Flow|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440595|NCT00895180|P1|Participant Flow|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440596|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440597|NCT00895180|O1|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440598|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440599|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440600|NCT00895180|O1|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440601|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440602|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440603|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440604|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440605|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440606|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440607|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440608|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440609|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440610|NCT00895180|E2|Reported Event|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440611|NCT00895180|E1|Reported Event|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
440612|NCT00895011|B4|Baseline|Total|Total of all reporting groups
440618|NCT00895011|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
440619|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
440620|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
440621|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
440622|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
440623|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
440624|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
440625|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
440626|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
440627|NCT00895011|O1|Outcome|Placebo|placeb 30 minutes orally prior to initiation of sexual activity
440628|NCT00895011|E3|Reported Event|Avanafil 200 mg|
440629|NCT00895011|E2|Reported Event|Avanafil 100 mg|
440630|NCT00895011|E1|Reported Event|Placebo|
440631|NCT00894933|B1|Baseline|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440632|NCT00894933|P1|Participant Flow|Continuum|"Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.~CONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy."
440633|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440634|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440635|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440636|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440637|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440638|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440639|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440640|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440641|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440642|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440643|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440644|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440645|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440646|NCT00894933|E1|Reported Event|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
440647|NCT00894803|B3|Baseline|Total|Total of all reporting groups
440648|NCT00894803|B2|Baseline|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440649|NCT00894803|B1|Baseline|Rt-PA Only|rt-PA (0.9 mg/kg)
440650|NCT00894803|P2|Participant Flow|Rt-PA Only|recombinant tissue Plasminogen Activator (rt-PA; 0.9 mg/kg)
440651|NCT00894803|P1|Participant Flow|Rt-PA and Eptifibatide|recombinant tissue Plasminogen Activator (rt-PA; 0.6 mg/kg) and Epifibatide (225 mcg/kg)
440652|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440653|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440654|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440655|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440656|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440657|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440658|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440659|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440660|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440661|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440662|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440663|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440664|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440665|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440666|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440667|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440668|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440669|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440670|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440671|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440672|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440676|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440677|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440678|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440679|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440680|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440681|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
440682|NCT00894803|E2|Reported Event|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
440683|NCT00894803|E1|Reported Event|Rt-PA Only|rt-PA (0.9 mg/kg)
440684|NCT00894790|B3|Baseline|Total|Total of all reporting groups
440685|NCT00894790|B2|Baseline|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440686|NCT00894790|B1|Baseline|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440687|NCT00894790|P2|Participant Flow|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440688|NCT00894790|P1|Participant Flow|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440689|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440690|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440691|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440692|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440693|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440694|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440695|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440696|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440697|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440698|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440699|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440700|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440701|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440702|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440703|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440704|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440705|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440706|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440707|NCT00894790|E2|Reported Event|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
440708|NCT00894790|E1|Reported Event|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
440709|NCT00894699|B3|Baseline|Total|Total of all reporting groups
440710|NCT00894699|B2|Baseline|Placebo|Single dose of Placebo
440711|NCT00894699|B1|Baseline|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil/Triazolam 15/200 mcg NanoTab™
440712|NCT00894699|P2|Participant Flow|Single Dose of Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
440713|NCT00894699|P1|Participant Flow|Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
440714|NCT00894699|O2|Outcome|Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
440715|NCT00894699|O1|Outcome|Sublingual Sufentanil 15 mcg/Triazolam NanoTab™ 200 mcg|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
440716|NCT00894699|E2|Reported Event|Placebo|Single dose of Placebo
440717|NCT00894699|E1|Reported Event|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
440718|NCT00894647|B3|Baseline|Total|Total of all reporting groups
440719|NCT00894647|B2|Baseline|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
440720|NCT00894647|B1|Baseline|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
440721|NCT00894647|P2|Participant Flow|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
440722|NCT00894647|P1|Participant Flow|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
440723|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
440724|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
440725|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
440726|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
440727|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
440728|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
440729|NCT00894647|E2|Reported Event|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
440730|NCT00894647|E1|Reported Event|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
440731|NCT00894556|B4|Baseline|Total|Total of all reporting groups
440793|NCT00894504|O5|Outcome|PTEN Normal|
440732|NCT00894556|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
440733|NCT00894556|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
440734|NCT00894556|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
440735|NCT00894556|P4|Participant Flow|Sumatriptan 100 mg|Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study.
440736|NCT00894556|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT"
440737|NCT00894556|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT."
440738|NCT00894556|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo."
440739|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
440740|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.~Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
440741|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
440742|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.~Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
440743|NCT00894556|E3|Reported Event|Sumatriptan 100 mg|"Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as Baseline Phase"
440744|NCT00894556|E2|Reported Event|Placebo|
440745|NCT00894556|E1|Reported Event|Rizatriptan 10 mg|"Patients took at least one dose of study medication. It is possible for one patient to be counted twice (once in each treatment group).~Although a patient may have had two or more adverse events of the same type, the patient is counted only once for that type of adverse event.~Adverse events occurring within 14 days of administration of Rizatriptan 10 mg are attributed to Rizatriptan 10 mg group even if placebo was administered more recently."
440746|NCT00894543|B3|Baseline|Total|Total of all reporting groups
440747|NCT00894543|B2|Baseline|Placebo|Inactive pill
440748|NCT00894543|B1|Baseline|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440749|NCT00894543|P2|Participant Flow|Placebo|Inactive pill
440750|NCT00894543|P1|Participant Flow|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440751|NCT00894543|O2|Outcome|Placebo|Inactive pill
440752|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440753|NCT00894543|O2|Outcome|Placebo|Inactive pill
440754|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440755|NCT00894543|O2|Outcome|Placebo|Inactive pill
440756|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440757|NCT00894543|O2|Outcome|Placebo|Inactive pill
440794|NCT00894504|O4|Outcome|p53 Loss|
440795|NCT00894504|O3|Outcome|p53 Normal|
440758|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440759|NCT00894543|O2|Outcome|Placebo|Inactive pill
440760|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440761|NCT00894543|O2|Outcome|Placebo|Inactive pill
440762|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440763|NCT00894543|O2|Outcome|Placebo|Inactive pill
440764|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440765|NCT00894543|O2|Outcome|Placebo|Inactive pill
440766|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440767|NCT00894543|O2|Outcome|Placebo|Inactive pill
440768|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440769|NCT00894543|E2|Reported Event|Placebo|Inactive pill
440770|NCT00894543|E1|Reported Event|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
440771|NCT00894517|B3|Baseline|Total|Total of all reporting groups
440772|NCT00894517|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440773|NCT00894517|B1|Baseline|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440774|NCT00894517|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440775|NCT00894517|P1|Participant Flow|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440776|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440777|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440778|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440779|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440780|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440781|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440782|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440783|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440784|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440785|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440786|NCT00894517|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
440787|NCT00894517|E1|Reported Event|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
440788|NCT00894504|B1|Baseline|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
440789|NCT00894504|P1|Participant Flow|Panitumumab/Gemcitabine/Carboplatin|"Treatment cycles are repeated every 14 days (2 weeks)~Panitumumab: 6mg/kg intravenous (IV), Day 1 of each 2-week treatment cycle.~Gemcitabine: 1500mg/m2 IV, Day 1 of each 2-week treatment cycle~Carboplatin: Area Under the Curve (AUC) = 2.5 IV, Day 1 of each 2-week treatment cycle"
440790|NCT00894504|O8|Outcome|PIK3CA Mutation(s)|
440791|NCT00894504|O7|Outcome|PIK3CA No Mutation|
440799|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Systemic therapy
440800|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
440801|NCT00894504|E1|Reported Event|Panitumumab/Gemcitabine/Carboplatin|
440802|NCT00894465|B3|Baseline|Total|Total of all reporting groups
440803|NCT00894465|B2|Baseline|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
440804|NCT00894465|B1|Baseline|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
440805|NCT00894465|P2|Participant Flow|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
440806|NCT00894465|P1|Participant Flow|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
440807|NCT00894465|O2|Outcome|Placebo|Parents of patients who were given oral placebo prior to undergoing the VCUG.
440808|NCT00894465|O1|Outcome|Versed|Parents of patients who were given oral midazolam prior to undergoing the VCUG.
440809|NCT00894465|O2|Outcome|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
440810|NCT00894465|O1|Outcome|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
440811|NCT00894465|E2|Reported Event|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
440812|NCT00894465|E1|Reported Event|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
440813|NCT00894387|B3|Baseline|Total|Total of all reporting groups
440814|NCT00894387|B2|Baseline|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440815|NCT00894387|B1|Baseline|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440816|NCT00894387|P2|Participant Flow|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440817|NCT00894387|P1|Participant Flow|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440818|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440819|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440820|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440821|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440822|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440823|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440824|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440825|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440826|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440827|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440828|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440829|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440830|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440957|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440831|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440832|NCT00894387|E2|Reported Event|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
440833|NCT00894387|E1|Reported Event|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
440834|NCT00894361|B3|Baseline|Total|Total of all reporting groups
440835|NCT00894361|B2|Baseline|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
440836|NCT00894361|B1|Baseline|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
440837|NCT00894361|P2|Participant Flow|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
440838|NCT00894361|P1|Participant Flow|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
440839|NCT00894361|O2|Outcome|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
440840|NCT00894361|O1|Outcome|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
440841|NCT00894361|E2|Reported Event|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
440842|NCT00894361|E1|Reported Event|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
440843|NCT00894322|B4|Baseline|Total|Total of all reporting groups
440844|NCT00894322|B3|Baseline|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440845|NCT00894322|B2|Baseline|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
440846|NCT00894322|B1|Baseline|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440847|NCT00894322|P3|Participant Flow|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440848|NCT00894322|P2|Participant Flow|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
440849|NCT00894322|P1|Participant Flow|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440850|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440851|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440852|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440853|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440854|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440855|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440856|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440857|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440858|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440859|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440860|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440861|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440862|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440863|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440864|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440865|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440866|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440867|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440868|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440869|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440870|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440871|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440872|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440873|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440958|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440874|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440875|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440876|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440877|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440878|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440879|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440880|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440881|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440882|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440883|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440884|NCT00894322|E3|Reported Event|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440885|NCT00894322|E2|Reported Event|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
440886|NCT00894322|E1|Reported Event|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
440887|NCT00894244|B1|Baseline|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
440888|NCT00894244|P1|Participant Flow|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
440889|NCT00894244|O1|Outcome|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
440890|NCT00894244|E1|Reported Event|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
440891|NCT00894166|B9|Baseline|Total|Total of all reporting groups
440892|NCT00894166|B8|Baseline|Withdrew Prior to Randomization|These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
440893|NCT00894166|B7|Baseline|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
440894|NCT00894166|B6|Baseline|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
440895|NCT00894166|B5|Baseline|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
440896|NCT00894166|B4|Baseline|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
440897|NCT00894166|B3|Baseline|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
440898|NCT00894166|B2|Baseline|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
440899|NCT00894166|B1|Baseline|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
440900|NCT00894166|P8|Participant Flow|Withdrew Prior to Randomization|"These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.~21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed."
440901|NCT00894166|P7|Participant Flow|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440902|NCT00894166|P6|Participant Flow|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
440903|NCT00894166|P5|Participant Flow|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
440904|NCT00894166|P4|Participant Flow|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440905|NCT00894166|P3|Participant Flow|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
440906|NCT00894166|P2|Participant Flow|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
440907|NCT00894166|P1|Participant Flow|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440908|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440909|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
440921|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440922|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
441334|NCT00893074|E2|Reported Event|30mg|30mg dronabinol maintenance
440910|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
440911|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440912|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
440913|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
440914|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440915|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440916|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
440917|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
440918|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
440919|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
440920|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
440956|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440923|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
440924|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
440925|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
440926|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
440927|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
440928|NCT00894166|O1|Outcome|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
440929|NCT00894166|E7|Reported Event|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
440930|NCT00894166|E6|Reported Event|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
440931|NCT00894166|E5|Reported Event|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
440932|NCT00894166|E4|Reported Event|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
440933|NCT00894166|E3|Reported Event|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
440934|NCT00894166|E2|Reported Event|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
440935|NCT00894166|E1|Reported Event|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
440936|NCT00894127|B1|Baseline|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
440937|NCT00894127|P1|Participant Flow|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
440938|NCT00894127|O1|Outcome|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
440939|NCT00894127|E1|Reported Event|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
440940|NCT00893997|B1|Baseline|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
440941|NCT00893997|P1|Participant Flow|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
440942|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
440943|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
440944|NCT00893997|E1|Reported Event|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
440945|NCT00893971|B1|Baseline|All Subjects|Any treatment arm
440946|NCT00893971|P1|Participant Flow|Overall Study|All patients randomized
440947|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440948|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440949|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440950|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440951|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440952|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440953|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440954|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440955|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440959|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440960|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440961|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440962|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440963|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440964|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440965|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440966|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440967|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440968|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440969|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440970|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440971|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440972|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440973|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440974|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440975|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440976|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440977|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440978|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440979|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440980|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440981|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440982|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440983|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440984|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440985|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440986|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440987|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440988|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440989|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440990|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440991|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440992|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440993|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440994|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440995|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
440996|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
440997|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
440998|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
440999|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441000|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441001|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441002|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441003|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441004|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441005|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441006|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441007|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441008|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441009|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441010|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441011|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441012|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441013|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441014|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441015|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441016|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441017|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441018|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441019|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441020|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441021|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441022|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441023|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441024|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441025|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441026|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441027|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441028|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441029|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441030|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441031|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441032|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441033|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441034|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441035|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441036|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441037|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441038|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441039|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441040|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441041|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441042|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441043|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441044|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441045|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441046|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441047|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441048|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441049|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441050|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441051|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441052|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441053|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441054|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441055|NCT00893971|E4|Reported Event|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
441056|NCT00893971|E3|Reported Event|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
441057|NCT00893971|E2|Reported Event|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
441058|NCT00893971|E1|Reported Event|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
441059|NCT00893789|B5|Baseline|Total|Total of all reporting groups
441060|NCT00893789|B4|Baseline|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441061|NCT00893789|B3|Baseline|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441062|NCT00893789|B2|Baseline|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441063|NCT00893789|B1|Baseline|Placebo|Oral placebo tablets, once daily (QD)
441064|NCT00893789|P4|Participant Flow|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441065|NCT00893789|P3|Participant Flow|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441066|NCT00893789|P2|Participant Flow|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441067|NCT00893789|P1|Participant Flow|Placebo|Oral placebo tablets, once daily (QD)
441068|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441069|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441070|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441071|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441072|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441073|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441074|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441075|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441076|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441077|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441078|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441079|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441080|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441081|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441082|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441083|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441084|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441085|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441086|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441087|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441088|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441089|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441090|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441091|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441092|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441093|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441094|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441095|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441096|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441097|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441098|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441099|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441100|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441101|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441102|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441103|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441104|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441105|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441106|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441107|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441108|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441109|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441110|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441111|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441112|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441113|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441114|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441115|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441116|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441117|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441118|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441119|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441120|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441121|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441122|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441123|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441124|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441125|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441126|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441127|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441128|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441129|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441130|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441131|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441132|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441133|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441134|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441135|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441136|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441137|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441138|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441139|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441140|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441141|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441142|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441143|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
441144|NCT00893789|E4|Reported Event|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
441145|NCT00893789|E3|Reported Event|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
441146|NCT00893789|E2|Reported Event|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
441147|NCT00893789|E1|Reported Event|Placebo|Oral placebo tablets, once daily (QD)
441148|NCT00893763|B3|Baseline|Total|Total of all reporting groups
441149|NCT00893763|B2|Baseline|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
441335|NCT00893074|E1|Reported Event|Placebo|Placebo maintenance
441336|NCT00892957|B3|Baseline|Total|Total of all reporting groups
441150|NCT00893763|B1|Baseline|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
441151|NCT00893763|P2|Participant Flow|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
441152|NCT00893763|P1|Participant Flow|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
441153|NCT00893763|O2|Outcome|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
441154|NCT00893763|O1|Outcome|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
441155|NCT00893763|O2|Outcome|2: COntrol|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
441156|NCT00893763|O1|Outcome|1: Preintubation Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
441157|NCT00893763|E2|Reported Event|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
441158|NCT00893763|E1|Reported Event|1: Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
441159|NCT00893737|B1|Baseline|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
441160|NCT00893737|P1|Participant Flow|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
441161|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
441162|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
441163|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
441164|NCT00893737|E1|Reported Event|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
441165|NCT00893464|B9|Baseline|Total|Total of all reporting groups
441166|NCT00893464|B8|Baseline|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441167|NCT00893464|B7|Baseline|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441168|NCT00893464|B6|Baseline|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441169|NCT00893464|B5|Baseline|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441170|NCT00893464|B4|Baseline|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441171|NCT00893464|B3|Baseline|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441172|NCT00893464|B2|Baseline|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441173|NCT00893464|B1|Baseline|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441174|NCT00893464|P8|Participant Flow|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441175|NCT00893464|P7|Participant Flow|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441176|NCT00893464|P6|Participant Flow|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441177|NCT00893464|P5|Participant Flow|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708) 1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441178|NCT00893464|P4|Participant Flow|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441179|NCT00893464|P3|Participant Flow|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441180|NCT00893464|P2|Participant Flow|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441181|NCT00893464|P1|Participant Flow|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity.
441182|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441732|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441183|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441184|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441185|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441186|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441187|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441188|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441189|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441190|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441191|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441192|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441193|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441194|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441195|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441196|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441197|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441198|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441199|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441200|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441201|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441202|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441203|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441204|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441205|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441206|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441207|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441208|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441209|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441210|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441211|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441212|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441213|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441214|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441215|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441216|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441217|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441218|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441219|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441220|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441221|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441222|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441223|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441224|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441225|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441226|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441227|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441228|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441229|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity..
441230|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441231|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441232|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441233|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441234|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441235|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441236|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441237|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441238|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441239|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441240|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441241|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441242|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441243|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441244|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441245|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441246|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441247|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441248|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441249|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441250|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441251|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441252|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441253|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441254|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441255|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441256|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441257|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441258|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441259|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441260|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441261|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441262|NCT00893464|O1|Outcome|All Participants|All participants who received MLN9708 at dose 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 and 3.11 mg/m^2 in Phase 1.
441263|NCT00893464|O1|Outcome|All Participants|All participants who received ixazomib (MLN9708) 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 or 3.11 mg/m^2 in dose-escalation cohorts .
441264|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441265|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441266|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441267|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441268|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441269|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441270|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441271|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441272|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441273|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441274|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441275|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441276|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441277|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441278|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441279|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441280|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m²|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441281|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441282|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441283|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441284|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441285|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441286|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441287|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441288|NCT00893464|E8|Reported Event|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441289|NCT00893464|E7|Reported Event|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441290|NCT00893464|E6|Reported Event|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441291|NCT00893464|E5|Reported Event|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441292|NCT00893464|E4|Reported Event|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441293|NCT00893464|E3|Reported Event|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441294|NCT00893464|E2|Reported Event|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441295|NCT00893464|E1|Reported Event|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
441296|NCT00893152|B3|Baseline|Total|Total of all reporting groups
441297|NCT00893152|B2|Baseline|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
441298|NCT00893152|B1|Baseline|Veterans|Participants in focus groups or individual qualitative interviews
441299|NCT00893152|P2|Participant Flow|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
441300|NCT00893152|P1|Participant Flow|Veterans|Participants in focus groups or individual qualitative interviews
441301|NCT00893152|O2|Outcome|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
441302|NCT00893152|O1|Outcome|Veterans|Participants in focus groups or individual qualitative interviews
441303|NCT00893152|E2|Reported Event|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
441304|NCT00893152|E1|Reported Event|Veterans|Participants in focus groups or individual qualitative interviews
441305|NCT00893113|B3|Baseline|Total|Total of all reporting groups
441306|NCT00893113|B2|Baseline|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
441307|NCT00893113|B1|Baseline|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
441308|NCT00893113|P2|Participant Flow|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
441309|NCT00893113|P1|Participant Flow|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
441310|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
441311|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
441312|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
441313|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
441314|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
441315|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
441316|NCT00893113|E2|Reported Event|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
441317|NCT00893113|E1|Reported Event|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
441318|NCT00893074|B1|Baseline|Study Participant|Participants who received active drug as part of the study
441319|NCT00893074|P1|Participant Flow|0, 30, 60, and 120mg Dronabinol|0, 30, 60, and 120mg Dronabinol administered for 5 consecutive days in a double blind, placebo controlled study, with dose administered in a random order to the same study participants
441320|NCT00893074|O4|Outcome|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
441321|NCT00893074|O3|Outcome|60mg Dronabinol|60mg (20mg tid) dronabinol maintenance
441322|NCT00893074|O2|Outcome|30mg Dronabinol|30mg (10mg tid) dronabinol maintenance
441323|NCT00893074|O1|Outcome|Placebo|placebo dronabinol maintenance
441324|NCT00893074|O4|Outcome|120mg Dronabinol|120mg (40mg tid) dronabinol maintenance
441325|NCT00893074|O3|Outcome|60mg Dronabinol|60mg (20mg tid) dronabinol maintenance
441326|NCT00893074|O2|Outcome|30mg Dronabinol|30mg (10mg tid) dronabinol maintenance
441327|NCT00893074|O1|Outcome|Placebo|Placebo dronabinol maintenance
441328|NCT00893074|O4|Outcome|120mg Dronabinol|120mg daily dronabinol (40mg tid) administered for 5 days
441329|NCT00893074|O3|Outcome|60mg Dronabinol|60mg daily dronabinol (20mg tid) administered for 5 days
441330|NCT00893074|O2|Outcome|30mg Dronabinol|30mg daily dronabinol (10mg tid) administered for 5 days
441331|NCT00893074|O1|Outcome|Placebo|0mg daily dronabinol administered for 5 days
441332|NCT00893074|E4|Reported Event|120mg|120mg dronabinol maintenance
441333|NCT00893074|E3|Reported Event|60mg|60mg dronabinol maintenance
441337|NCT00892957|B2|Baseline|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
441338|NCT00892957|B1|Baseline|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
441339|NCT00892957|P2|Participant Flow|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
441340|NCT00892957|P1|Participant Flow|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
441341|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441342|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441343|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441344|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441345|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441346|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441347|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441348|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441349|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441350|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441351|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441352|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441353|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441354|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441355|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441356|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441357|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441358|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441359|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441360|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441361|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441362|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441363|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441364|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441365|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441366|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441367|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441368|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441369|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441370|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441371|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441372|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441373|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441374|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441375|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441376|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441377|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441378|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441379|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441380|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441381|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
441382|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
441383|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
441384|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
441385|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441386|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
441387|NCT00892957|O2|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441388|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
441389|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441390|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441391|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441392|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
441393|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441394|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
441395|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441396|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
441397|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441398|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441399|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441400|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
441401|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441402|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
441403|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
441404|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
441405|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441406|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441407|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441408|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441409|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441410|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441411|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441412|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441413|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441414|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441415|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441416|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441417|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441418|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441419|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441420|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441421|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
441422|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
441423|NCT00892957|E2|Reported Event|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
441424|NCT00892957|E1|Reported Event|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
441425|NCT00892775|B3|Baseline|Total|Total of all reporting groups
441426|NCT00892775|B2|Baseline|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441427|NCT00892775|B1|Baseline|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441428|NCT00892775|P2|Participant Flow|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441429|NCT00892775|P1|Participant Flow|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441430|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441431|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441432|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441433|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441434|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441435|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441436|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441437|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441438|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441439|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441440|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441441|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441442|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441443|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441444|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441445|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441446|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441447|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441448|NCT00892775|O2|Outcome|Priorix-Tetra Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441449|NCT00892775|O1|Outcome|Priorix-Tetra New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441450|NCT00892775|E2|Reported Event|Priorix-Tetra™ Current WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine manufactured with current working seed virus or new measles and rubella working seeds at Day 0 and Week 12.
441451|NCT00892775|E1|Reported Event|Priorix-Tetra™ New WS Group|Subjects received 2 doses of Priorix-Tetra™ vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
441452|NCT00892723|B4|Baseline|Total|Total of all reporting groups
441453|NCT00892723|B3|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441454|NCT00892723|B2|Baseline|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441455|NCT00892723|B1|Baseline|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441456|NCT00892723|P3|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441457|NCT00892723|P2|Participant Flow|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441458|NCT00892723|P1|Participant Flow|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441459|NCT00892723|O9|Outcome|Scar Total Volume - 1 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441460|NCT00892723|O8|Outcome|Scar Total Volume - 0.3 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441461|NCT00892723|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441462|NCT00892723|O6|Outcome|Scar Negative Volume - 1 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441463|NCT00892723|O5|Outcome|Scar Negative Volume - 0.3 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441464|NCT00892723|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441465|NCT00892723|O3|Outcome|Scar Positive Volume - 1 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441466|NCT00892723|O2|Outcome|Scar Positive Volume - 0.3 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 0.3 mg AZx100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441467|NCT00892723|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441468|NCT00892723|O15|Outcome|Scar Mean Elevation - 1 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441469|NCT00892723|O14|Outcome|Scar Mean Elevation - 0.3 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441470|NCT00892723|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441471|NCT00892723|O12|Outcome|Scar Maximum Elevation - 1 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441472|NCT00892723|O11|Outcome|Scar Maximum Elevation - 0.3 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441473|NCT00892723|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441474|NCT00892723|O9|Outcome|Scar Minimum Elevation - 1 mg AZX100|This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441475|NCT00892723|O8|Outcome|Scar Minimum Elevation - 0.3 mg AZX100|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441476|NCT00892723|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441477|NCT00892723|O6|Outcome|Scar Width - 1 mg AZX100|This group included Month 12 scar width measurements (mm)for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441478|NCT00892723|O5|Outcome|Scar Width - 0.3 mg AZX100|This group included Month 12 scar width measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441479|NCT00892723|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441480|NCT00892723|O3|Outcome|Scar Length - 1 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441481|NCT00892723|O2|Outcome|Scar Length - 0.3 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441482|NCT00892723|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length measurements (mm)for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441483|NCT00892723|O6|Outcome|Rater 2 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441484|NCT00892723|O5|Outcome|Rater 2 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441485|NCT00892723|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441486|NCT00892723|O3|Outcome|Rater 1 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441487|NCT00892723|O2|Outcome|Rater 1 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441488|NCT00892723|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441489|NCT00892723|O6|Outcome|OSAS Results for 1 mg AZX100|This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441490|NCT00892723|O5|Outcome|OSAS Results for 0.3 mg AZX100|This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441491|NCT00892723|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441492|NCT00892723|O3|Outcome|PSAS Results for 1 mg AZX100|This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441493|NCT00892723|O2|Outcome|PSAS Results for 0.3 mg AZX100|This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441733|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441494|NCT00892723|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
441495|NCT00892723|E3|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441496|NCT00892723|E2|Reported Event|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441497|NCT00892723|E1|Reported Event|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
441498|NCT00892710|B4|Baseline|Total|Total of all reporting groups
441499|NCT00892710|B3|Baseline|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441500|NCT00892710|B2|Baseline|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441501|NCT00892710|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441502|NCT00892710|P3|Participant Flow|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441503|NCT00892710|P2|Participant Flow|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441504|NCT00892710|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441505|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441506|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441507|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441508|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441509|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441510|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441511|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441512|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441513|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441514|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441515|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441516|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441517|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441518|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441519|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441520|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441521|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441522|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441523|NCT00892710|E3|Reported Event|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
441524|NCT00892710|E2|Reported Event|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
441525|NCT00892710|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
441526|NCT00892697|B1|Baseline|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
441527|NCT00892697|P1|Participant Flow|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
441528|NCT00892697|O1|Outcome|Telaprevir/PEG-IFN/RBV|15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
441529|NCT00892697|O1|Outcome|Telaprevir/Peg-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
441530|NCT00892697|E1|Reported Event|Telaprevir/PEG-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
441531|NCT00892606|B3|Baseline|Total|Total of all reporting groups
441532|NCT00892606|B2|Baseline|Control|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine
441533|NCT00892606|B1|Baseline|Methadone|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg of methadone IV immediately after intubation
441534|NCT00892606|P2|Participant Flow|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
441535|NCT00892606|P1|Participant Flow|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
441536|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
441537|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
441538|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
441539|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
441540|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
441541|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
441542|NCT00892606|E2|Reported Event|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
441543|NCT00892606|E1|Reported Event|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
441544|NCT00892437|B3|Baseline|Total|Total of all reporting groups
441545|NCT00892437|B2|Baseline|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441546|NCT00892437|B1|Baseline|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441547|NCT00892437|P2|Participant Flow|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441548|NCT00892437|P1|Participant Flow|ATV+COBI+FTC/TDF|"Randomized Phase: Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441549|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441550|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441551|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441552|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441553|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441554|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441555|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441556|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441557|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441558|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441559|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441560|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
441561|NCT00892437|E3|Reported Event|All ATV+COBI+FTC/TDF|The All ATV+COBI+FTC/TDF Safety Analysis Set included all participants who received at least 1 dose of COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind ATV+COBI+FTC/TDF group while they received double-blind ATV+COBI+FTC/TDF during the randomized phase and open-label ATV+COBI+FTC/TDF during the extension phase; adverse events collected from the open-label ATV+COBI+FTC/TDF extension phase only from the participants who were initially randomized to the ATV+RTV+FTC/TDF group during the randomized phase. Adverse event data collected up to Week 286 are presented in this entry.
441562|NCT00892437|E2|Reported Event|ATV+RTV+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive RTV 100 mg+COBI placebo+ATV 300 mg+FTC 200 mg/TDF 300 mg once daily in the randomized period, and were analyzed from Baseline to Week 60.
441563|NCT00892437|E1|Reported Event|ATV+COBI+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily in the randomized phase, and were analyzed from Baseline to Week 60.
441564|NCT00892281|B3|Baseline|Total|Total of all reporting groups
441565|NCT00892281|B2|Baseline|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
441566|NCT00892281|B1|Baseline|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
441567|NCT00892281|P2|Participant Flow|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
441568|NCT00892281|P1|Participant Flow|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
441569|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
441570|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
441571|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
441572|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
441573|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
441574|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
441575|NCT00892281|E2|Reported Event|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
441576|NCT00892281|E1|Reported Event|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
441577|NCT00892177|B4|Baseline|Total|Total of all reporting groups
441578|NCT00892177|B3|Baseline|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441579|NCT00892177|B2|Baseline|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441580|NCT00892177|B1|Baseline|Phase I|Patients receive (either: 5 or 10 mg/kg) bevacizumab IV over 90 minutes on Day 1 and oral dasatinib (either: 50, 70, or 100 mg) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441581|NCT00892177|P6|Participant Flow|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441582|NCT00892177|P5|Participant Flow|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441583|NCT00892177|P4|Participant Flow|Phase I: Dose Level 3|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441584|NCT00892177|P3|Participant Flow|Phase I: Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441585|NCT00892177|P2|Participant Flow|Phase I: Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441586|NCT00892177|P1|Participant Flow|Phase I: Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441587|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441588|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441734|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441589|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441590|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441591|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441592|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441593|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441594|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441595|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441596|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441597|NCT00892177|O2|Outcome|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441598|NCT00892177|O1|Outcome|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441599|NCT00892177|O5|Outcome|Phase I: Dose Level 3 Cohort 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441600|NCT00892177|O4|Outcome|Phase I : Dose Level 3 Cohort 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441601|NCT00892177|O3|Outcome|Phase I : Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 70 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441602|NCT00892177|O2|Outcome|Phase I : Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441603|NCT00892177|O1|Outcome|Phase I : Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 50 mg twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441604|NCT00892177|E6|Reported Event|Phase II: Arm B (Bevacizumab + Placebo)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral placebo twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441605|NCT00892177|E5|Reported Event|Phase II: Arm A (Bevacizumab + Dasatinib)|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and oral dasatinib 100 mg (2 tablets) twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441606|NCT00892177|E4|Reported Event|Phase I: Dose Level 3|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 100 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441607|NCT00892177|E3|Reported Event|Phase I: Dose Level 2|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 70 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441608|NCT00892177|E2|Reported Event|Phase I: Dose Level 1|Patients receive 10 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441609|NCT00892177|E1|Reported Event|Phase I: Dose Level 0|Patients receive 5 mg/kg bevacizumab IV over 90 minutes on Day 1 and 50 mg oral dasatinib twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
441610|NCT00892151|B1|Baseline|Intended Users of the Software|Baseline measures apply to lay persons (n=40) not healthcare professionals in the study.
441611|NCT00892151|P1|Participant Flow|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
441612|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
441613|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
441614|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
441615|NCT00892151|E1|Reported Event|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
441616|NCT00892099|B4|Baseline|Total|Total of all reporting groups
441617|NCT00892099|B3|Baseline|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441618|NCT00892099|B2|Baseline|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441619|NCT00892099|B1|Baseline|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441620|NCT00892099|P3|Participant Flow|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441621|NCT00892099|P2|Participant Flow|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441622|NCT00892099|P1|Participant Flow|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441623|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441624|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441625|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441626|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441627|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441628|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441629|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441630|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441631|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441632|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441633|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441634|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441635|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441636|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441637|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441638|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441639|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441640|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441641|NCT00892099|E3|Reported Event|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
441642|NCT00892099|E2|Reported Event|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
441643|NCT00892099|E1|Reported Event|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
441644|NCT00892047|B3|Baseline|Total|Total of all reporting groups
441645|NCT00892047|B2|Baseline|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
441646|NCT00892047|B1|Baseline|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
441647|NCT00892047|P2|Participant Flow|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
441648|NCT00892047|P1|Participant Flow|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
441649|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
441650|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
441651|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
441652|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
441653|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
441654|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
441655|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
441656|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
441657|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
441658|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
441659|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
441660|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
441661|NCT00892047|E2|Reported Event|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
441662|NCT00892047|E1|Reported Event|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
441663|NCT00892008|B1|Baseline|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441664|NCT00892008|P1|Participant Flow|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441665|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441666|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441667|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441668|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441669|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441670|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441671|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441672|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441673|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441674|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441675|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441676|NCT00892008|E1|Reported Event|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
441677|NCT00891995|B3|Baseline|Total|Total of all reporting groups
441678|NCT00891995|B2|Baseline|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441679|NCT00891995|B1|Baseline|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441680|NCT00891995|P2|Participant Flow|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441681|NCT00891995|P1|Participant Flow|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.
441682|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441683|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441684|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441685|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441686|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441687|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441688|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441689|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441690|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441691|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441692|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441693|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441694|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441695|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441696|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441697|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441698|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441699|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441700|NCT00891995|E2|Reported Event|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
441701|NCT00891995|E1|Reported Event|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
441702|NCT00891982|B3|Baseline|Total|Total of all reporting groups
441703|NCT00891982|B2|Baseline|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441704|NCT00891982|B1|Baseline|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441705|NCT00891982|P2|Participant Flow|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441706|NCT00891982|P1|Participant Flow|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441707|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441708|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441709|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441710|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441711|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441712|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441713|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441714|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441715|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441716|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441717|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441718|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441719|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441720|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441721|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441722|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441723|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441724|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441725|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441726|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441727|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441728|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441729|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441730|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441731|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441795|NCT00891774|E1|Reported Event|Device|Treatment with EVOLENCE®
441735|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441736|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441737|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441738|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441739|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441740|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441741|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441742|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441743|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441744|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441745|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441746|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441747|NCT00891982|E2|Reported Event|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
441748|NCT00891982|E1|Reported Event|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
441749|NCT00891930|B1|Baseline|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441750|NCT00891930|P1|Participant Flow|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441751|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441752|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441753|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441754|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441755|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441756|NCT00891930|O1|Outcome|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441757|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441758|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441759|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441760|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441761|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441762|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441763|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441764|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441765|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441766|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441767|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441768|NCT00891930|E2|Reported Event|Part-2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
441769|NCT00891930|E1|Reported Event|Part-1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
441770|NCT00891904|B1|Baseline|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
441796|NCT00891735|B5|Baseline|Total|Total of all reporting groups
441771|NCT00891904|P1|Participant Flow|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
441772|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
441773|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
441774|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
441775|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
441776|NCT00891904|E1|Reported Event|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
441777|NCT00891839|B1|Baseline|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441778|NCT00891839|P1|Participant Flow|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441779|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441780|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441781|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441782|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441783|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441784|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441785|NCT00891839|E1|Reported Event|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
441786|NCT00891813|B1|Baseline|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
441787|NCT00891813|P1|Participant Flow|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
441788|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
441789|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
441790|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
441791|NCT00891813|E1|Reported Event|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
441792|NCT00891774|B1|Baseline|Device|Treatment with EVOLENCE®
441793|NCT00891774|P1|Participant Flow|Device|Treatment with EVOLENCE®
441794|NCT00891774|O1|Outcome|Device|Treatment with EVOLENCE®
441797|NCT00891735|B4|Baseline|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441798|NCT00891735|B3|Baseline|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441799|NCT00891735|B2|Baseline|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441800|NCT00891735|B1|Baseline|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441801|NCT00891735|P4|Participant Flow|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441802|NCT00891735|P3|Participant Flow|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441803|NCT00891735|P2|Participant Flow|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441804|NCT00891735|P1|Participant Flow|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441805|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441806|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441807|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441808|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441809|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441810|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441811|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441812|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441813|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441814|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441815|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441816|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441817|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441818|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441819|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441820|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441821|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441850|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
441891|NCT00891436|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
441822|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441823|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441824|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441825|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441826|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441827|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441828|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441829|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441830|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441831|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441832|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441833|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441834|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441835|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441836|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441837|NCT00891735|E4|Reported Event|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
441838|NCT00891735|E3|Reported Event|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
441839|NCT00891735|E2|Reported Event|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
441840|NCT00891735|E1|Reported Event|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
441841|NCT00891657|B3|Baseline|Total|Total of all reporting groups
441842|NCT00891657|B2|Baseline|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
441843|NCT00891657|B1|Baseline|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
441844|NCT00891657|P2|Participant Flow|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
441845|NCT00891657|P1|Participant Flow|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
441846|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
441847|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
441848|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
441849|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
441851|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
441852|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
441853|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
441854|NCT00891657|E2|Reported Event|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
441855|NCT00891657|E1|Reported Event|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
441856|NCT00891618|B1|Baseline|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
441857|NCT00891618|P1|Participant Flow|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
441858|NCT00891618|O1|Outcome|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
441859|NCT00891618|E1|Reported Event|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
441860|NCT00891527|B1|Baseline|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
441861|NCT00891527|P1|Participant Flow|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
441862|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease, significant lung disease, and those who progressed were also treated with Avastin (bevacizumab).
441863|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
441864|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease, significant lung disease, and those who progressed were also treated with Avastin (bevacizumab).
441865|NCT00891527|E1|Reported Event|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
441866|NCT00891462|B4|Baseline|Total|Total of all reporting groups
441867|NCT00891462|B3|Baseline|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
441868|NCT00891462|B2|Baseline|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
441869|NCT00891462|B1|Baseline|Placebo|Inhaled placebo for 12 weeks
441870|NCT00891462|P3|Participant Flow|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
441871|NCT00891462|P2|Participant Flow|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
441872|NCT00891462|P1|Participant Flow|Placebo|Inhaled placebo for 12 weeks
441873|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
441874|NCT00891462|O2|Outcome|Aclidinium Bromide, 200 µg|Aclidinium bromide, 200 µg dose, Oral inhalation, twice per day, for 12 weeks of treatment
441875|NCT00891462|O1|Outcome|Placebo|Dose matched placebo twice per day, inhaled for 12 weeks of treatment
441876|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
441877|NCT00891462|O2|Outcome|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
441878|NCT00891462|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment
441879|NCT00891462|E3|Reported Event|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
441880|NCT00891462|E2|Reported Event|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
441881|NCT00891462|E1|Reported Event|Placebo|Inhaled placebo for 12 weeks
441882|NCT00891436|B3|Baseline|Total|Total of all reporting groups
441883|NCT00891436|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
441884|NCT00891436|B1|Baseline|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
441885|NCT00891436|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
441886|NCT00891436|P1|Participant Flow|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
441887|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
441888|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
441889|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
441890|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
441892|NCT00891436|E1|Reported Event|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
441893|NCT00891371|B1|Baseline|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
441894|NCT00891371|P1|Participant Flow|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
441895|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
441896|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
441897|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
441898|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
441899|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
441900|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
441901|NCT00891371|E1|Reported Event|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
441902|NCT00891319|B3|Baseline|Total|Total of all reporting groups
441903|NCT00891319|B2|Baseline|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed t10 sessions per week at home."
441904|NCT00891319|B1|Baseline|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
441905|NCT00891319|P2|Participant Flow|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed t10 sessions per week at home."
441906|NCT00891319|P1|Participant Flow|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
441907|NCT00891319|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed 10 sessions per week at home."
441908|NCT00891319|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
441909|NCT00891319|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed 10 sessions per week at home."
441910|NCT00891319|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
441911|NCT00891319|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed 10 sessions per week at home."
441912|NCT00891319|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
441913|NCT00891319|E2|Reported Event|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation~*Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the paretic hand.~12-week intervention~Lab: Therapist-guided task practice performed twice a week in the research laboratory.~Home: Self-administered cNMES-mediated hand opening exercise performed 10 sessions per week at home."
442278|NCT00890981|E1|Reported Event|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
441914|NCT00891319|E1|Reported Event|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~*Stimulation to paretic finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand. A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and controls stimulation intensity delivered to the affected hand.~12-week intervention~Lab: Therapist-guided CCFES-assisted task practice performed twice a week in the research laboratory.~Home: Self-administered CCFES-mediated hand opening exercise performed 10 sessions per week at home."
441915|NCT00891293|B1|Baseline|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441916|NCT00891293|P1|Participant Flow|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441917|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441918|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441919|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441920|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441921|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441922|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441923|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441924|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441925|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441926|NCT00891293|E1|Reported Event|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
441927|NCT00891228|B4|Baseline|Total|Total of all reporting groups
441928|NCT00891228|B3|Baseline|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441929|NCT00891228|B2|Baseline|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441930|NCT00891228|B1|Baseline|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441931|NCT00891228|P3|Participant Flow|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441963|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
442309|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
441932|NCT00891228|P2|Participant Flow|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441933|NCT00891228|P1|Participant Flow|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441934|NCT00891228|O3|Outcome|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441935|NCT00891228|O2|Outcome|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441936|NCT00891228|O1|Outcome|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441937|NCT00891228|O3|Outcome|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441938|NCT00891228|O2|Outcome|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441939|NCT00891228|O1|Outcome|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441940|NCT00891228|O3|Outcome|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441941|NCT00891228|O2|Outcome|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441942|NCT00891228|O1|Outcome|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441943|NCT00891228|O3|Outcome|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441944|NCT00891228|O2|Outcome|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441945|NCT00891228|O1|Outcome|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441946|NCT00891228|O3|Outcome|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441947|NCT00891228|O2|Outcome|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441948|NCT00891228|O1|Outcome|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441949|NCT00891228|E3|Reported Event|Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head."
441950|NCT00891228|E2|Reported Event|Testosterone Gel 10 g and Nestorone® 8 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head."
441951|NCT00891228|E1|Reported Event|Testosterone Gel 10 g and Nestorone® 0 mg Per Day|"Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.~Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.~Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head."
441952|NCT00891202|B3|Baseline|Total|Total of all reporting groups
441953|NCT00891202|B2|Baseline|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
441954|NCT00891202|B1|Baseline|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
441955|NCT00891202|P4|Participant Flow|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441956|NCT00891202|P3|Participant Flow|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441957|NCT00891202|P2|Participant Flow|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
441958|NCT00891202|P1|Participant Flow|PAP: Eliglustat|Eliglustat tartrate capsule as a single 50 milligram (mg) dose on Day 1 followed by eliglustat tartrate 50 mg capsule twice daily (BID) from Day 2 to Week 4, and then either eliglustat tartrate 50 mg capsule BID (in participants who had a Genz-99067 [active moiety of eliglustat tartrate in plasma] trough plasma concentration greater than or equal to [>=] 5 nanogram per milliliter [ng/mL]) or eliglustat tartrate 100 mg capsule BID (in participants who had a Genz-99067 trough plasma concentration less than [<] 5 ng/mL), up to Week 39. The pharmacokinetic (PK) assessment at Week 2 was used for dose adjustment after Week 4.
441959|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441960|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441961|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441962|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
442143|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442310|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
441964|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441965|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441966|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441967|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
441968|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
441969|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
441970|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
441971|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
441972|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
441973|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
441974|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
441975|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
441976|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
441977|NCT00891202|E2|Reported Event|Placebo|PAP: Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39. LTTP: Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline for LTTP. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441978|NCT00891202|E1|Reported Event|Eliglustat|PAP: Eliglustat tartrate capsule 50 mg orally on Day 1 followed by eliglustat tartrate 50 mg capsule BID from Day 2 to Week 4, then either eliglustat tartrate 50 mg capsule BID(participants with Genz-99067 trough plasma concentration>=5 ng/mL) or eliglustat tartrate 100 mg capsule BID(participants with Genz-99067 trough plasma concentration<5 ng/mL), up to Week 39. PK assessment at Week 2 used for dose adjustment after Week 4. LTTP: Participants of the eliglustat arm in PAP who completed PAP were included in LTTP & received eliglustat tartrate capsule 50 mg BID orally from Day 1(post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 & Week 47 were based on Genz-99067 trough plasma concentrations(if trough plasma concentration<5 ng/mL: next higher dose administered;if>=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
441979|NCT00891176|B5|Baseline|Total|Total of all reporting groups
441980|NCT00891176|B4|Baseline|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441981|NCT00891176|B3|Baseline|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442144|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
441982|NCT00891176|B2|Baseline|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441983|NCT00891176|B1|Baseline|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441984|NCT00891176|P4|Participant Flow|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441985|NCT00891176|P3|Participant Flow|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441986|NCT00891176|P2|Participant Flow|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441987|NCT00891176|P1|Participant Flow|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441988|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441989|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441990|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441991|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442145|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442311|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
442312|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
441992|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441993|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441994|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441995|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441996|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441997|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
441998|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
441999|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442000|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age.~3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta."
442001|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age.~3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta."
442002|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age.~3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~(In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations).~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa."
442313|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
442003|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age.~3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~(In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations).~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa."
442004|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age.~3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta."
442005|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age.~3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta."
442006|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age.~3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~(In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations).~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa."
442007|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|"Subjects who received concomitantly in the primary study (NCT00334334):~3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age.~3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age.~(In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations).~During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa."
442008|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442009|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442010|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442011|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442012|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442013|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442314|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
442014|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442015|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442016|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442017|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442018|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442019|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442020|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442021|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442022|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442023|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442024|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442025|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442026|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442027|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442028|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442029|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442030|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442031|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442032|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442033|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442034|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442035|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442036|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442037|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442038|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442039|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442040|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442041|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442042|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442043|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442044|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442045|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442046|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442315|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
442047|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442048|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442049|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442050|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442051|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442052|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442053|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442054|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442055|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442056|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442057|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442316|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
442058|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442059|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442060|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442061|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442062|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442063|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442064|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442065|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442066|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442067|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442068|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442069|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442070|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442071|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442072|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442073|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442074|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442075|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442076|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442077|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442078|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442079|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442080|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442081|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442082|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442083|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442084|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442085|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442086|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442087|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442088|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442089|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442090|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442317|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
442091|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442092|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442093|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442094|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442095|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442096|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442097|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442098|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442099|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442100|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442101|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442318|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
442102|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442103|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442104|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442105|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442106|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442107|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442108|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442109|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442110|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442111|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442112|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442113|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442114|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442115|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442116|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442117|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442118|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442119|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442120|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442121|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442122|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442123|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442124|NCT00891176|E4|Reported Event|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442125|NCT00891176|E3|Reported Event|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
442126|NCT00891176|E2|Reported Event|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442127|NCT00891176|E1|Reported Event|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
442128|NCT00891046|B6|Baseline|Total|Total of all reporting groups
442129|NCT00891046|B5|Baseline|ACZ885 Treatment Naive|Participants who were canakinumab treatment­ naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442130|NCT00891046|B4|Baseline|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442131|NCT00891046|B3|Baseline|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442132|NCT00891046|B2|Baseline|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442133|NCT00891046|B1|Baseline|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442134|NCT00891046|P5|Participant Flow|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442135|NCT00891046|P4|Participant Flow|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442136|NCT00891046|P3|Participant Flow|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442137|NCT00891046|P2|Participant Flow|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed Study CACZ885G2301 (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442138|NCT00891046|P1|Participant Flow|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from Study CACZ885G2301 Part 2 (NCT00889863) due to SJIA flare, received a subcutaneous (s.c.).
442139|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442140|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442141|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442142|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442275|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442146|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442147|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442148|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442149|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442150|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442151|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442152|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442153|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442154|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442155|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442156|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442157|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442158|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442159|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442160|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442161|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442162|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442163|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442164|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442165|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442166|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442167|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442276|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442168|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442169|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442170|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442171|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442172|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442173|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442174|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442175|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442176|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442177|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442178|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442179|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442180|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442181|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442182|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442183|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442184|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442185|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442186|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442187|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442188|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442189|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442319|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
442190|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to other biologics, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442191|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued other biologics for other reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442192|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued other biologics for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442193|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment­ naive and who discontinued other biologics due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442194|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to tocilizumab, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442195|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442196|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442197|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued tocilizumab due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442198|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to anakinra, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442199|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442200|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442201|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued anakinra due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442202|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442203|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442204|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442205|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442206|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442207|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442208|NCT00891046|E2|Reported Event|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
442209|NCT00891046|E1|Reported Event|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
442210|NCT00891020|B4|Baseline|Total|Total of all reporting groups
442211|NCT00891020|B3|Baseline|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442212|NCT00891020|B2|Baseline|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442213|NCT00891020|B1|Baseline|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442214|NCT00891020|P3|Participant Flow|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442215|NCT00891020|P2|Participant Flow|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442216|NCT00891020|P1|Participant Flow|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442217|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442218|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442219|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442220|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442221|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442222|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442223|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442224|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442225|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442226|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442227|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442228|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442229|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442230|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442231|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442232|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442233|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442234|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442235|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442236|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442237|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442238|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442239|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442240|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442241|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442242|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442277|NCT00890981|E2|Reported Event|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442243|NCT00891020|E3|Reported Event|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442244|NCT00891020|E2|Reported Event|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442245|NCT00891020|E1|Reported Event|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
442246|NCT00890981|B3|Baseline|Total|Total of all reporting groups
442247|NCT00890981|B2|Baseline|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442248|NCT00890981|B1|Baseline|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442249|NCT00890981|P2|Participant Flow|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442250|NCT00890981|P1|Participant Flow|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study.
442251|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442252|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442253|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442254|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442255|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442256|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442257|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442258|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442259|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442260|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442261|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442262|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442263|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442264|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442265|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442266|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442267|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442268|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442269|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442270|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442271|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442272|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442273|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
442274|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
442320|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
442279|NCT00890929|B1|Baseline|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442280|NCT00890929|P1|Participant Flow|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442281|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442282|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442283|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442284|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442285|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442286|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442287|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442288|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442289|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442290|NCT00890929|E1|Reported Event|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
442291|NCT00890916|B1|Baseline|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the IST-12 System."
442292|NCT00890916|P1|Participant Flow|Neuroprosthesis System|Subjects who have undergone implantation of the neuroprosthesis system known as the FIRSTHAND/IST-12 System.
442293|NCT00890916|O1|Outcome|Neuroprosthesis System|Subjects with the implanted FIRSTHAND/IST-12 System.
442294|NCT00890916|E1|Reported Event|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels."
442295|NCT00890721|B3|Baseline|Total|Total of all reporting groups
442296|NCT00890721|B2|Baseline|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
442297|NCT00890721|B1|Baseline|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
442298|NCT00890721|P2|Participant Flow|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
442299|NCT00890721|P1|Participant Flow|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
442300|NCT00890721|O2|Outcome|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
442301|NCT00890721|O1|Outcome|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
442302|NCT00890721|E2|Reported Event|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
442303|NCT00890721|E1|Reported Event|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
442304|NCT00890695|B3|Baseline|Total|Total of all reporting groups
442305|NCT00890695|B2|Baseline|2 Normal Diet|normal diet arm
442306|NCT00890695|B1|Baseline|1 RUSF|RUSF prescribed for the child for 4 weeks
442307|NCT00890695|P2|Participant Flow|2 Normal Diet|For equity, parents or guardians of children in the usual diet arm are given 2 bags of maize meal (4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.
442308|NCT00890695|P1|Participant Flow|1 Ready to Use Supplementary Food (RUSF)|"Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K).~initial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day."
442322|NCT00890695|E1|Reported Event|1 RUSF|RUSF prescribed for the child for 4 weeks
442323|NCT00890682|B3|Baseline|Total|Total of all reporting groups
442324|NCT00890682|B2|Baseline|Placebo|Study Drug Injection
442325|NCT00890682|B1|Baseline|Sky0402|Injection of Study Drug
442326|NCT00890682|P2|Participant Flow|Placebo|Injection of 8cc Placebo (single dose)
442327|NCT00890682|P1|Participant Flow|SKY0402|Injection of 8cc SKY0402 (single dose)
442328|NCT00890682|O2|Outcome|Placebo|Single injection of study drug
442329|NCT00890682|O1|Outcome|SKY0402|Single injection of study drug
442330|NCT00890682|E2|Reported Event|Placebo|Study Drug Injection
442331|NCT00890682|E1|Reported Event|Sky0402|Injection of Study Drug
442332|NCT00890656|B1|Baseline|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
442333|NCT00890656|P1|Participant Flow|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
442334|NCT00890656|O1|Outcome|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
442335|NCT00890656|E1|Reported Event|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
442336|NCT00890591|B1|Baseline|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
442337|NCT00890591|P1|Participant Flow|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
442338|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide + Amlodipine|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets + amlodipine tablets 5 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
442339|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
442340|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 20 mg/hydrochlorothiazide 12.5 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
442341|NCT00890591|O1|Outcome|Olmesartan Monotherapy|olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
442342|NCT00890552|B1|Baseline|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
442343|NCT00890552|P1|Participant Flow|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
442344|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
442345|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
442403|NCT00889915|P3|Participant Flow|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
442346|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
442347|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
442348|NCT00890552|E1|Reported Event|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
442349|NCT00890409|B3|Baseline|Total|Total of all reporting groups
442350|NCT00890409|B2|Baseline|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
442351|NCT00890409|B1|Baseline|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
442352|NCT00890409|P2|Participant Flow|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
442353|NCT00890409|P1|Participant Flow|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
442354|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
442355|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
442356|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
442357|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
442358|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
442359|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
442360|NCT00890201|B3|Baseline|Total|Total of all reporting groups
442361|NCT00890201|B2|Baseline|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
442362|NCT00890201|B1|Baseline|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
442363|NCT00890201|P2|Participant Flow|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
442364|NCT00890201|P1|Participant Flow|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
442365|NCT00890201|O2|Outcome|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
442366|NCT00890201|O1|Outcome|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
442367|NCT00890201|E2|Reported Event|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
442718|NCT00888355|P3|Participant Flow|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442368|NCT00890201|E1|Reported Event|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
442369|NCT00890097|B4|Baseline|Total|Total of all reporting groups
442370|NCT00890097|B3|Baseline|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442371|NCT00890097|B2|Baseline|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442372|NCT00890097|B1|Baseline|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
442373|NCT00890097|P3|Participant Flow|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442374|NCT00890097|P2|Participant Flow|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442375|NCT00890097|P1|Participant Flow|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
442376|NCT00890097|O3|Outcome|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442377|NCT00890097|O2|Outcome|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442378|NCT00890097|O1|Outcome|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
442379|NCT00890097|E3|Reported Event|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442380|NCT00890097|E2|Reported Event|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
442381|NCT00890097|E1|Reported Event|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
442382|NCT00890084|B1|Baseline|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442383|NCT00890084|P1|Participant Flow|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442384|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442385|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442386|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442387|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442388|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442389|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442390|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442391|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442392|NCT00890084|E1|Reported Event|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
442393|NCT00889928|B1|Baseline|Cholecystectomy|transvaginal cholecystectomy
442394|NCT00889928|P1|Participant Flow|Cholecystectomy|transvaginal cholecystectomy
442395|NCT00889928|O1|Outcome|Transvaginal Cholecystectomy|
442396|NCT00889928|E1|Reported Event|Cholecystectomy|transvaginal cholecystectomy
442397|NCT00889915|B5|Baseline|Total|Total of all reporting groups
442398|NCT00889915|B4|Baseline|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~The dose form for is 5, 10, 15, 20, 25, 30 mg capsules. The typical starting dose for children greater than or equal to 6 years of age is 10 mg every day.~The FDA maximum dose per day is 30 mg if weight is greater than 50 kilograms. The off label maximum dose per day is 60 mg. The capsule may be opened and sprinkled on soft foods."
442399|NCT00889915|B3|Baseline|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 18, 27, 36, 54 mg capsules. The typical starting dose is 18 mg every morning. The FDA maximum dose per day is 54 mg in children or 72 mg in adolescents. The off label maximum dose is 108 mg. Longer acting stimulants offer greater convenience, confidentiality, and compliance with single daily dosing, but may have greater problematic effects on evening appetite and sleep. Its nonabsorbable tablet shell may appear in the stool.~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
442400|NCT00889915|B2|Baseline|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 20, 30, 40, 50, 60, 70 mg ivory body/ivory cap. The typical starting dose is 30 mg every day in the morning; dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals.~The FDA maximum dose per day is 70 mg. Afternoon doses should be avoided because of the potential for insomnia. Vyvanse may be taken with or without food. Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. The solution should be consumed immediately and should not be stored. The dose of a single capsule should not be divided."
442401|NCT00889915|B1|Baseline|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system. Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form as 10, 15, 20, 30 mg patches. Typical starting dose is 10 mg patch every day then titrate up by patch strength.~The FDA maximum dose per day is 30 mg and the off label maximum dose per day is 40 mg.~The patch should be applied to the hip area, avoiding the waistline and the patch application should be alternated between hips."
442402|NCT00889915|P4|Participant Flow|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
442489|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
442404|NCT00889915|P2|Participant Flow|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
442405|NCT00889915|P1|Participant Flow|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
442406|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
442407|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
442408|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
442409|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
442410|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
442411|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
442412|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
442413|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
442414|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
442415|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
442416|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
442417|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
442418|NCT00889915|E4|Reported Event|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
442419|NCT00889915|E3|Reported Event|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
442420|NCT00889915|E2|Reported Event|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
442421|NCT00889915|E1|Reported Event|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
442422|NCT00889863|B1|Baseline|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442423|NCT00889863|P2|Participant Flow|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442424|NCT00889863|P1|Participant Flow|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442425|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442452|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442490|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
442426|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442427|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442428|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442429|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442430|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442431|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442432|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442433|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442434|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442435|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442453|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442647|NCT00888849|P2|Participant Flow|Suturing|4 layered hand-sutured anastomosis
442436|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442437|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442438|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442439|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442440|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442441|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442442|NCT00889863|E3|Reported Event|Placebo: Part II|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442443|NCT00889863|E2|Reported Event|Canakinumab: Part II|Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
442444|NCT00889863|E1|Reported Event|Canakinumab: Part I|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period.
442445|NCT00889824|B1|Baseline|Balcap Group|Each participant received Balcap Tactile prosthesis
442446|NCT00889824|P1|Participant Flow|Balcap Group|"Balcap group~Balcap group; balance prosthesis : vibrotactile stimulation~Patients wore a Balcap device that provided a vibrotactile stimulation that felt like a buzz either in front, back, or either side of their head when they swayed a certain distance from their center.~They wore the device daily and performed specific personalized exercises as prescribed by a physical therapist. They were tested with and without the balcap during tests of balance and postural stability when they first received the balcap and again six weeks later.~Each patient wore the balcap device a total of six weeks and then returned the device."
442447|NCT00889824|O1|Outcome|Balcap Group|Vibrotactile stimulation exercises with the device over a span of 6 weeks
442448|NCT00889824|E1|Reported Event|Balcap Group|Each participant received Balcap Tactile prosthesis
442449|NCT00889720|B1|Baseline|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442450|NCT00889720|P1|Participant Flow|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442451|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442648|NCT00888849|P1|Participant Flow|Stapling|
442454|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442455|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442456|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442457|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442458|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442459|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442460|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442461|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442462|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442463|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442464|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442465|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442466|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442467|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442468|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442469|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442470|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442471|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442472|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442473|NCT00889720|E1|Reported Event|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
442474|NCT00889707|B3|Baseline|Total|Total of all reporting groups
442475|NCT00889707|B2|Baseline|Placebo|2% HSA without PRX302
442476|NCT00889707|B1|Baseline|PRX302|0.6 microgram/gram prostate in 2% HSA
442477|NCT00889707|P2|Participant Flow|Placebo|2% (weight/volume) human serum albumin (HSA) without PRX302
442478|NCT00889707|P1|Participant Flow|PRX302|0.6 microgram/gram prostate weight in 2% (weight/volume) human serum albumin (HSA)
442479|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
442480|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
442481|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
442482|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
442483|NCT00889707|E2|Reported Event|Placebo|2% HSA without PRX302
442484|NCT00889707|E1|Reported Event|PRX302|0.6 microgram/gram prostate in 2% HSA
442485|NCT00889681|B1|Baseline|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.
442486|NCT00889681|P1|Participant Flow|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
442487|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
442488|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
442491|NCT00889681|E1|Reported Event|Treated With Cryoablation|"This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF (Atrial Fibrillation Drugs  or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.~Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation."
442492|NCT00889603|B1|Baseline|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442493|NCT00889603|P1|Participant Flow|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442494|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442495|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442496|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442497|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442498|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442499|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442500|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442501|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442502|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442503|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442504|NCT00889603|E1|Reported Event|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
442505|NCT00889512|B3|Baseline|Total|Total of all reporting groups
442506|NCT00889512|B2|Baseline|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
442507|NCT00889512|B1|Baseline|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
442508|NCT00889512|P2|Participant Flow|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
442509|NCT00889512|P1|Participant Flow|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
442510|NCT00889512|O2|Outcome|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
442511|NCT00889512|O1|Outcome|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
442512|NCT00889512|E2|Reported Event|Group B|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
442513|NCT00889512|E1|Reported Event|Group A|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
442514|NCT00889421|B1|Baseline|Treatment|Patient receiving apremilast.
442515|NCT00889421|P1|Participant Flow|Treatment|Patient receiving apremilast.
442516|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
442517|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
442518|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
442519|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
442520|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
442521|NCT00889421|E1|Reported Event|Treatment|Patient receiving apremilast.
442522|NCT00889330|B3|Baseline|Total|Total of all reporting groups
442523|NCT00889330|B2|Baseline|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442524|NCT00889330|B1|Baseline|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442525|NCT00889330|P2|Participant Flow|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442649|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
442650|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
442526|NCT00889330|P1|Participant Flow|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442527|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442528|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442529|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442530|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442531|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442532|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442533|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442534|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442535|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442536|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442537|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442538|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442539|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442540|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442541|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442542|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442543|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442544|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442545|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442546|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442547|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442548|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442549|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442550|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442551|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442552|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442553|NCT00889330|E2|Reported Event|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442554|NCT00889330|E1|Reported Event|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
442555|NCT00889265|B1|Baseline|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
442556|NCT00889265|P1|Participant Flow|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
442557|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
442558|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
442651|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
442652|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
442559|NCT00889265|E1|Reported Event|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
442560|NCT00889252|B3|Baseline|Total|Total of all reporting groups
442561|NCT00889252|B2|Baseline|Placebo Lens|contact lens without drug
442562|NCT00889252|B1|Baseline|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442563|NCT00889252|P2|Participant Flow|Placebo Lens|contact lens without drug
442564|NCT00889252|P1|Participant Flow|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442565|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442566|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442567|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442568|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442569|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442570|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442571|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442572|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442573|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442574|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442575|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442576|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442577|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442578|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442579|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442580|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442581|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442582|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442583|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442584|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442585|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442586|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442587|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442588|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442589|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442590|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442591|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442592|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442593|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442594|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442595|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442596|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442597|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442598|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442599|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442600|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442601|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
442602|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442603|NCT00889252|E2|Reported Event|Placebo Lens|contact lens without drug
442604|NCT00889252|E1|Reported Event|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
442605|NCT00889200|B1|Baseline|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
442606|NCT00889200|P1|Participant Flow|Open-label Eszopiclone|"Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
442607|NCT00889200|O1|Outcome|Open-label Eszopiclone|After Standard dosing of drug for 6 weeks for insomnia, Dex/CRH test was repeated to measure cortisol reactivity with the same neuroendocrine test
442608|NCT00889200|E1|Reported Event|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
442609|NCT00889187|B1|Baseline|All Phase I: Photon Rad+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~All Phase I participants received the radiation regimen according to the established dose escalation schedule.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442653|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
442654|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
442655|NCT00888849|E2|Reported Event|Suturing|4 layered hand-sutured anastomosis
442610|NCT00889187|P4|Participant Flow|Phase II: Photon Rad (MTD)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442611|NCT00889187|P3|Participant Flow|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442612|NCT00889187|P2|Participant Flow|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442613|NCT00889187|P1|Participant Flow|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442614|NCT00889187|O1|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442615|NCT00889187|O1|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442616|NCT00889187|O1|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442617|NCT00889187|O1|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442618|NCT00889187|O1|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442619|NCT00889187|O1|Outcome|Experimental: Phase II: Photon Rad (MTD)+Capecitabine|"Phase II participants received the radiation regimen established in the Phase I study (MTD).~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442620|NCT00889187|O3|Outcome|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442621|NCT00889187|O2|Outcome|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442622|NCT00889187|O1|Outcome|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442623|NCT00889187|O1|Outcome|All Phase I: Photon Rad+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~All Phase I participants received the radiation regimen according to the established dose escalation schedule.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442624|NCT00889187|E3|Reported Event|Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 3, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 5 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442625|NCT00889187|E2|Reported Event|Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 2, a total dose of 25 Gy in 5 fractions was prescribed to the 95% isodose and administered at 5 Gy per fraction over 11 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442626|NCT00889187|E1|Reported Event|Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine|"Neoadjuvant Short-Course Photon Radiation:~At dose level 1, a total dose of 30 Gy in 10 fractions (3 Gy/day) was prescribed to the 95% isodose and administered 5 days per week over 12 days.~Chemotherapy:~Capecitabine was given orally 825 mg/m2 BID (total 1650 mg/m2 per day) for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy.~Patients underwent resection of their pancreatic cancer 1-3 weeks after the completion of chemoradiation. It was recommended that patients undergoing R0 or R1 resections receive adjuvant treatment with 4-6 cycles of gemcitabine-based therapy per institutional policy, to start 4 to 10 weeks after the operation."
442627|NCT00888979|B1|Baseline|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
442628|NCT00888979|P1|Participant Flow|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
442629|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
442630|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
442631|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
442632|NCT00888979|E1|Reported Event|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
442633|NCT00888940|B3|Baseline|Total|Total of all reporting groups
442634|NCT00888940|B2|Baseline|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
442635|NCT00888940|B1|Baseline|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
442636|NCT00888940|P2|Participant Flow|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
442637|NCT00888940|P1|Participant Flow|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
442638|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
442639|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
442640|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
442641|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
442642|NCT00888940|E2|Reported Event|Cyklokapron|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
442643|NCT00888940|E1|Reported Event|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
442644|NCT00888849|B3|Baseline|Total|Total of all reporting groups
442645|NCT00888849|B2|Baseline|Suturing|4 layered hand-sutured anastomosis
442646|NCT00888849|B1|Baseline|Stapling|
442657|NCT00888654|B1|Baseline|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
442658|NCT00888654|P1|Participant Flow|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
442659|NCT00888654|O1|Outcome|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
442660|NCT00888654|O1|Outcome|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
442661|NCT00888654|O1|Outcome|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
442662|NCT00888654|E1|Reported Event|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
442663|NCT00888628|B1|Baseline|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442664|NCT00888628|P1|Participant Flow|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442665|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442666|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442667|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442668|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442669|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442670|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442719|NCT00888355|P2|Participant Flow|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442720|NCT00888355|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
442721|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442722|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442671|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442672|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442673|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442674|NCT00888628|E1|Reported Event|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
442675|NCT00888459|B3|Baseline|Total|Total of all reporting groups
442676|NCT00888459|B2|Baseline|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
442677|NCT00888459|B1|Baseline|Active|4 mg nicotine lozenges
442678|NCT00888459|P2|Participant Flow|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
442679|NCT00888459|P1|Participant Flow|Active|4 mg nicotine lozenges
442680|NCT00888459|O2|Outcome|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
442681|NCT00888459|O1|Outcome|Active|4 mg nicotine lozenges
442682|NCT00888459|E2|Reported Event|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
442683|NCT00888459|E1|Reported Event|Active|4 mg nicotine lozenges
442684|NCT00888433|B3|Baseline|Total|Total of all reporting groups
442685|NCT00888433|B2|Baseline|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
442686|NCT00888433|B1|Baseline|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
442687|NCT00888433|P2|Participant Flow|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
442688|NCT00888433|P1|Participant Flow|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
442689|NCT00888433|O2|Outcome|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
442690|NCT00888433|O1|Outcome|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
442691|NCT00888433|E2|Reported Event|2. CONTROL|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
442692|NCT00888433|E1|Reported Event|1. DENERVATION|Renal Denervation and maintenance of anti-hypertensive medications
442693|NCT00888381|B3|Baseline|Total|Total of all reporting groups
442694|NCT00888381|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
442695|NCT00888381|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
442696|NCT00888381|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
442697|NCT00888381|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
442698|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
442699|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
442700|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
442701|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
442702|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
442703|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
442704|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
442705|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
442706|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
442707|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
442708|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
442709|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
442710|NCT00888381|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
442711|NCT00888381|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
442712|NCT00888355|B5|Baseline|Total|Total of all reporting groups
442713|NCT00888355|B4|Baseline|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442714|NCT00888355|B3|Baseline|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442715|NCT00888355|B2|Baseline|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442716|NCT00888355|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
442717|NCT00888355|P4|Participant Flow|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442723|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442724|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442725|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442726|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442727|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442728|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442729|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442730|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442731|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442732|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442733|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442734|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442735|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442736|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442737|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442738|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442739|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442740|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442741|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442742|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442743|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442744|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442745|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442746|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442747|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442748|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442749|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442750|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442751|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442752|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442753|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442754|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442755|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442756|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442757|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442758|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442759|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442760|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442761|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442762|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442763|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442764|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442765|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442766|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442767|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442768|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442769|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
442770|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
442771|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
442772|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
442773|NCT00888329|B3|Baseline|Total|Total of all reporting groups
442774|NCT00888329|B2|Baseline|Placebo|Placebo
442775|NCT00888329|B1|Baseline|Aprepitant|40 mg aprepitant
442776|NCT00888329|P2|Participant Flow|Placebo|Placebo
442777|NCT00888329|P1|Participant Flow|Aprepitant|40 mg aprepitant
442778|NCT00888329|O2|Outcome|Placebo|Placebo
442779|NCT00888329|O1|Outcome|Aprepitant|40 mg aprepitant
442780|NCT00888329|E2|Reported Event|Placebo|Placebo
442781|NCT00888329|E1|Reported Event|Aprepitant|40 mg aprepitant
442782|NCT00888238|B1|Baseline|All Patients|All Randomized patients
442783|NCT00888238|P3|Participant Flow|Placebo / Sitagliptin / Sitagliptin|Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
442784|NCT00888238|P2|Participant Flow|Sitagliptin / Placebo / Sitagliptin|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
442785|NCT00888238|P1|Participant Flow|Sitagliptin / Sitagliptin / Placebo|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo
442786|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
442787|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
442788|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
442789|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
442790|NCT00888238|E2|Reported Event|Placebo|12 subjects received a single-dose of placebo in 1 period.
442791|NCT00888238|E1|Reported Event|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
442792|NCT00888173|B1|Baseline|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442793|NCT00888173|P1|Participant Flow|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442794|NCT00888173|O1|Outcome|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442795|NCT00888173|O1|Outcome|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442796|NCT00888173|O1|Outcome|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442797|NCT00888173|O1|Outcome|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442798|NCT00888173|O1|Outcome|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442799|NCT00888173|E1|Reported Event|Brivanib|Brivanib 800 mg orally every day (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy.
442800|NCT00888134|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
442801|NCT00888134|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
442802|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
442803|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Selumetinib: Given PO"
442804|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
442805|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
442806|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
442807|NCT00888134|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
442808|NCT00887978|B3|Baseline|Total|Total of all reporting groups
442809|NCT00887978|B2|Baseline|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
442810|NCT00887978|B1|Baseline|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
442811|NCT00887978|P2|Participant Flow|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
442812|NCT00887978|P1|Participant Flow|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
442813|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442814|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442815|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442816|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442817|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442818|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442819|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442820|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442821|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442822|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442823|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442824|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442825|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442826|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442827|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442828|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442829|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442830|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442831|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442832|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442833|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442834|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442835|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442836|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442837|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442838|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442839|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442840|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442841|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442842|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442843|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
442844|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
442845|NCT00887978|E2|Reported Event|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1 (3.6).
442846|NCT00887978|E1|Reported Event|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1 (1.9).
442847|NCT00887965|B1|Baseline|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442848|NCT00887965|P1|Participant Flow|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442849|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442850|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442851|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442852|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442853|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442854|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442855|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442856|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442857|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442858|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442859|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442860|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442861|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442862|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442863|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442864|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442865|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442866|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442867|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442868|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442869|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442870|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442871|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442872|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442873|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442874|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442875|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442876|NCT00887965|E1|Reported Event|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
442877|NCT00887913|B1|Baseline|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
442878|NCT00887913|P1|Participant Flow|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
442879|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
442880|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
442881|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
442882|NCT00887913|E1|Reported Event|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
442883|NCT00887822|B3|Baseline|Total|Total of all reporting groups
442884|NCT00887822|B2|Baseline|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442885|NCT00887822|B1|Baseline|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442886|NCT00887822|P2|Participant Flow|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442887|NCT00887822|P1|Participant Flow|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442888|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442889|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442890|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442891|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442892|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442893|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442894|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442895|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442896|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442897|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442898|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442899|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442921|NCT00887809|O2|Outcome|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
442922|NCT00887809|O1|Outcome|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
442923|NCT00887809|E2|Reported Event|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
442900|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442901|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442902|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442903|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442904|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442905|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442906|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442907|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442908|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442909|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442910|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442911|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442912|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442913|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442914|NCT00887822|E2|Reported Event|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442915|NCT00887822|E1|Reported Event|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
442916|NCT00887809|B3|Baseline|Total|Total of all reporting groups
442917|NCT00887809|B2|Baseline|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
442918|NCT00887809|B1|Baseline|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
442919|NCT00887809|P2|Participant Flow|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
442920|NCT00887809|P1|Participant Flow|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
442924|NCT00887809|E1|Reported Event|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
442925|NCT00887744|B1|Baseline|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
442926|NCT00887744|P1|Participant Flow|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
442927|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
442928|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
442929|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
442930|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
442931|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
442932|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
442933|NCT00887744|E1|Reported Event|ITT Analysis|Single group - Aperius
442934|NCT00887679|B1|Baseline|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442935|NCT00887679|P1|Participant Flow|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442936|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442937|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442938|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442939|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442940|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442941|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Subjects received escitalopram 10-20mg. Escitalopram was started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day.
442942|NCT00887679|E1|Reported Event|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
442943|NCT00887653|B1|Baseline|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
442944|NCT00887653|P1|Participant Flow|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
442945|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
442946|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
442947|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
442948|NCT00887653|E1|Reported Event|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
443086|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
442949|NCT00887640|B1|Baseline|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442950|NCT00887640|P1|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442951|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442952|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442953|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442954|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442955|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442956|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442957|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442958|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442959|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442960|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442961|NCT00887640|E1|Reported Event|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
442962|NCT00887588|B3|Baseline|Total|Total of all reporting groups
442963|NCT00887588|B2|Baseline|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442964|NCT00887588|B1|Baseline|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442965|NCT00887588|P2|Participant Flow|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442966|NCT00887588|P1|Participant Flow|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442967|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443131|NCT00887471|P2|Participant Flow|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
442968|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442969|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442970|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442971|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442972|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442973|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442974|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442975|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442976|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442977|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442978|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442979|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442980|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442981|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442982|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442983|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442984|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442985|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442986|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442987|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442988|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442989|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442990|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442991|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442992|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442993|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442994|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442995|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442996|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442997|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
442998|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
442999|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443000|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443001|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443002|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443003|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443004|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443005|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443006|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443007|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443008|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443009|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443010|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443011|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443012|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443013|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443014|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443015|NCT00887588|E2|Reported Event|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
443016|NCT00887588|E1|Reported Event|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
443017|NCT00887575|B1|Baseline|All Patients|Includes all patients treated at all dose levels
443018|NCT00887575|P3|Participant Flow|Dose Level III|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 6) day 1 of every cycle and Sunitinib PO (25mg) daily.
443019|NCT00887575|P2|Participant Flow|Dose Level II|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
443020|NCT00887575|P1|Participant Flow|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
443021|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
443022|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
443023|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
443024|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
443025|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
443026|NCT00887575|E1|Reported Event|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
443027|NCT00887562|B4|Baseline|Total|Total of all reporting groups
443028|NCT00887562|B3|Baseline|Placebo|"Placebo~Placebo: Placebo - No idebenone"
443029|NCT00887562|B2|Baseline|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
443030|NCT00887562|B1|Baseline|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
443031|NCT00887562|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo - No idebenone"
443032|NCT00887562|P2|Participant Flow|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
443033|NCT00887562|P1|Participant Flow|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
443034|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
443035|NCT00887562|O2|Outcome|2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
443036|NCT00887562|O1|Outcome|900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
443037|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
443038|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
443039|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
443040|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
443041|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
443042|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
443043|NCT00887562|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo - No idebenone"
443044|NCT00887562|E2|Reported Event|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
443045|NCT00887562|E1|Reported Event|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
443046|NCT00887549|B1|Baseline|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
443047|NCT00887549|P1|Participant Flow|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
443048|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
443049|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
443050|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
443051|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
443226|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443052|NCT00887549|E1|Reported Event|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
443053|NCT00887510|B3|Baseline|Total|Total of all reporting groups
443054|NCT00887510|B2|Baseline|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
443055|NCT00887510|B1|Baseline|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
443056|NCT00887510|P2|Participant Flow|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
443057|NCT00887510|P1|Participant Flow|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
443058|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
443059|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
443060|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
443061|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
443062|NCT00887510|E2|Reported Event|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
443063|NCT00887510|E1|Reported Event|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
443064|NCT00887484|B1|Baseline|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
443065|NCT00887484|P1|Participant Flow|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
443066|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
443067|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443068|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443069|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
443070|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443071|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443072|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
443073|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443074|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443075|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
443076|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443077|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443078|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
443079|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443080|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443081|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
443082|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443083|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443084|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443085|NCT00887484|O1|Outcome|All Subjects|Subjects applied both study products in a split-face fashion through week 2. Study products were applied once-daily in the evening.
443087|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443088|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443089|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443090|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443091|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443092|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443093|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443094|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443095|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443096|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443097|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443098|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443099|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443100|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443101|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443102|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443103|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443104|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443105|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443106|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443107|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443108|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443109|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443110|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443111|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443112|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443113|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443114|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443115|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443116|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443117|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443118|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443119|NCT00887484|O2|Outcome|Epiduo|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443120|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443121|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443122|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443123|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443124|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
443125|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443126|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
443127|NCT00887484|E1|Reported Event|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
443128|NCT00887471|B3|Baseline|Total|Total of all reporting groups
443129|NCT00887471|B2|Baseline|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
443130|NCT00887471|B1|Baseline|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
443132|NCT00887471|P1|Participant Flow|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
443133|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
443134|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
443135|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
443136|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
443137|NCT00887471|E2|Reported Event|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
443138|NCT00887471|E1|Reported Event|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
443139|NCT00887458|B3|Baseline|Total|Total of all reporting groups
443140|NCT00887458|B2|Baseline|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
443141|NCT00887458|B1|Baseline|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
443142|NCT00887458|P2|Participant Flow|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
443143|NCT00887458|P1|Participant Flow|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
443144|NCT00887458|O2|Outcome|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
443145|NCT00887458|O1|Outcome|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
443146|NCT00887458|O2|Outcome|High Dose Itraconazole|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
443147|NCT00887458|O1|Outcome|Low Dose Itraconazole|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
443148|NCT00887458|E2|Reported Event|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
443149|NCT00887458|E1|Reported Event|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
443150|NCT00887354|B3|Baseline|Total|Total of all reporting groups
443151|NCT00887354|B2|Baseline|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443152|NCT00887354|B1|Baseline|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443153|NCT00887354|P2|Participant Flow|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443154|NCT00887354|P1|Participant Flow|Teriparatide|"20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.~Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443155|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443156|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443157|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443158|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443159|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443160|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443161|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443162|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443163|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443189|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443164|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443165|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443166|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443167|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443168|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443169|NCT00887354|E2|Reported Event|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443170|NCT00887354|E1|Reported Event|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
443171|NCT00887341|B3|Baseline|Total|Total of all reporting groups
443172|NCT00887341|B2|Baseline|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443173|NCT00887341|B1|Baseline|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443174|NCT00887341|P2|Participant Flow|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443175|NCT00887341|P1|Participant Flow|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443176|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443177|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443178|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443179|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443180|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443181|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443182|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443183|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443184|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443185|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443186|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443187|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443188|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443190|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443191|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443192|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443193|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443194|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443195|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443196|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443197|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443198|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443199|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443200|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443201|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443202|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443203|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443204|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443205|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443206|NCT00887341|E2|Reported Event|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
443207|NCT00887341|E1|Reported Event|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
443208|NCT00887315|B3|Baseline|Total|Total of all reporting groups
443209|NCT00887315|B2|Baseline|Chemo and Radiation|Chemotherapy and radiotherapy
443210|NCT00887315|B1|Baseline|Chemo Only|Chemotherapy only
443211|NCT00887315|P2|Participant Flow|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
443212|NCT00887315|P1|Participant Flow|Chemo Only|Chemotherapy only
443213|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
443214|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
443215|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
443216|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
443217|NCT00887315|E2|Reported Event|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
443218|NCT00887315|E1|Reported Event|Chemo Only|Chemotherapy only
443219|NCT00887289|B1|Baseline|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443220|NCT00887289|P1|Participant Flow|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443221|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443222|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443223|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443224|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443225|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443227|NCT00887289|E1|Reported Event|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
443228|NCT00887250|B4|Baseline|Total|Total of all reporting groups
443229|NCT00887250|B3|Baseline|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443230|NCT00887250|B2|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443231|NCT00887250|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
443232|NCT00887250|P3|Participant Flow|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443233|NCT00887250|P2|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443234|NCT00887250|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
443235|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443236|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443237|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
443238|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443239|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443240|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
443241|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443242|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443243|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
443244|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443245|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443246|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
443247|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443248|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443249|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
443250|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
443251|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
443252|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
443253|NCT00887224|B4|Baseline|Total|Total of all reporting groups
443254|NCT00887224|B3|Baseline|DVS SR 50 mg (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population)."
443255|NCT00887224|B2|Baseline|Placebo (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population)."
443256|NCT00887224|B1|Baseline|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
443257|NCT00887224|P3|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
443258|NCT00887224|P2|Participant Flow|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
443259|NCT00887224|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
443260|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443261|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443262|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443263|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443264|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443265|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443266|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443267|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443268|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443269|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443270|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443271|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443272|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD..
443273|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443274|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443275|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443276|NCT00887224|E7|Reported Event|DVS SR 50 mg (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
443277|NCT00887224|E6|Reported Event|Placebo (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
443278|NCT00887224|E5|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
443279|NCT00887224|E4|Reported Event|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
443280|NCT00887224|E3|Reported Event|DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)|Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.
443281|NCT00887224|E2|Reported Event|DVS SR 50 mg (Open Label Stability Phase)|DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.
443282|NCT00887224|E1|Reported Event|DVS SR 50 mg (Open-label Response Phase)|DVS SR 50 mg PO QD for 8 weeks.
443283|NCT00887198|B3|Baseline|Total|Total of all reporting groups
443284|NCT00887198|B2|Baseline|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443285|NCT00887198|B1|Baseline|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443286|NCT00887198|P2|Participant Flow|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443287|NCT00887198|P1|Participant Flow|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443288|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443289|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443290|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443291|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443292|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443337|NCT00886938|O1|Outcome|rTMS|rTMS to the left dorsolateral prefrontal cortex for patients with tinnitus
443293|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443294|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443295|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443296|NCT00887198|O3|Outcome|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
443297|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443298|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443299|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443300|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443301|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443302|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443303|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443304|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443305|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443306|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443307|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443308|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443309|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443310|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443311|NCT00887198|E3|Reported Event|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
443312|NCT00887198|E2|Reported Event|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443313|NCT00887198|E1|Reported Event|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
443314|NCT00887159|B4|Baseline|Total|Total of all reporting groups
443338|NCT00886938|E1|Reported Event|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
443339|NCT00886899|B1|Baseline|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
443315|NCT00887159|B3|Baseline|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
443316|NCT00887159|B2|Baseline|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
443317|NCT00887159|B1|Baseline|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
443318|NCT00887159|P3|Participant Flow|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
443319|NCT00887159|P2|Participant Flow|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
443320|NCT00887159|P1|Participant Flow|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
443321|NCT00887159|O2|Outcome|Low CTC Count|Low CTC count is defined as <= 100 CTCs per 7.5 ml at baseline.
443322|NCT00887159|O1|Outcome|High CTC Count|High CTC count is defined as greater than 100 CTCs per 7.5 ml at baseline.
443323|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
443324|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
443325|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
443326|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
443327|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
443328|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
443329|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
443330|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
443331|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
443332|NCT00887159|E3|Reported Event|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
443333|NCT00887159|E2|Reported Event|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
443334|NCT00887159|E1|Reported Event|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
443335|NCT00886938|B1|Baseline|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
443336|NCT00886938|P1|Participant Flow|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
443340|NCT00886899|P1|Participant Flow|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
443341|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
443342|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
443343|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
443344|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
443345|NCT00886899|E1|Reported Event|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
443346|NCT00886834|B3|Baseline|Total|Total of all reporting groups
443347|NCT00886834|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
443348|NCT00886834|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
443349|NCT00886834|P2|Participant Flow|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
443350|NCT00886834|P1|Participant Flow|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
443351|NCT00886834|O2|Outcome|Placebo|
443352|NCT00886834|O1|Outcome|Misoprostol|
443353|NCT00886834|O2|Outcome|Placebo|
443354|NCT00886834|O1|Outcome|Misoprostol|
443355|NCT00886834|E2|Reported Event|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
443356|NCT00886834|E1|Reported Event|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
443357|NCT00886821|B15|Baseline|Total|Total of all reporting groups
443358|NCT00886821|B14|Baseline|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443359|NCT00886821|B13|Baseline|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443360|NCT00886821|B12|Baseline|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443361|NCT00886821|B11|Baseline|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443362|NCT00886821|B10|Baseline|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively.
443363|NCT00886821|B9|Baseline|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443364|NCT00886821|B8|Baseline|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443365|NCT00886821|B7|Baseline|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443366|NCT00886821|B6|Baseline|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443367|NCT00886821|B5|Baseline|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443368|NCT00886821|B4|Baseline|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443369|NCT00886821|B3|Baseline|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443370|NCT00886821|B2|Baseline|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443371|NCT00886821|B1|Baseline|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443372|NCT00886821|P14|Participant Flow|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443373|NCT00886821|P13|Participant Flow|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443374|NCT00886821|P12|Participant Flow|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443375|NCT00886821|P11|Participant Flow|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443376|NCT00886821|P10|Participant Flow|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443377|NCT00886821|P9|Participant Flow|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443378|NCT00886821|P8|Participant Flow|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443379|NCT00886821|P7|Participant Flow|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443380|NCT00886821|P6|Participant Flow|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443381|NCT00886821|P5|Participant Flow|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443382|NCT00886821|P4|Participant Flow|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443383|NCT00886821|P3|Participant Flow|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443384|NCT00886821|P2|Participant Flow|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443385|NCT00886821|P1|Participant Flow|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443386|NCT00886821|O4|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443794|NCT00886119|O2|Outcome|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
443387|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443388|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443389|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443390|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443391|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443392|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443393|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443394|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443395|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443396|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443397|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443398|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443399|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443400|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443401|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443402|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443403|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443404|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443405|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443406|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443407|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443408|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443409|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443410|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443411|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443412|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443413|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443414|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443415|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443416|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443417|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443418|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443419|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443420|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443421|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443422|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443423|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443424|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443425|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443426|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443427|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443428|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443429|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443430|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443431|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443432|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443433|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443434|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443435|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443436|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443437|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443438|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443439|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443440|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443441|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443442|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443443|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443444|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443445|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443446|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443447|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443448|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443449|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443450|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443451|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443452|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443453|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443454|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443455|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443456|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443457|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443458|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443459|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443460|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443461|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443462|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443463|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443464|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443465|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443466|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443467|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443468|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443469|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443470|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443471|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443472|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443473|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443474|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443475|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443476|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443477|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443478|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443479|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443480|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443481|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443482|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443483|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443484|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443485|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443486|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443487|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443488|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443489|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443490|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443491|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443492|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443493|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443494|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443495|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
443496|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443497|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443498|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443499|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443500|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443501|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443502|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443503|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443504|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443505|NCT00886821|O14|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443506|NCT00886821|O13|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443507|NCT00886821|O12|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443508|NCT00886821|O11|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443509|NCT00886821|O10|Outcome|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443510|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443511|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443512|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443513|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443514|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443515|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443516|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443517|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443518|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443519|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443520|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443521|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443522|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443523|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443524|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443525|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443526|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443527|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443528|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443529|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443530|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443531|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443532|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443533|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443534|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443535|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443536|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443537|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443538|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443539|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443540|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443541|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443542|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443543|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443544|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443545|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443546|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443547|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443548|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443549|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443550|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443551|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443552|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443553|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443554|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443555|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443556|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443557|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443558|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443559|NCT00886821|O12|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443560|NCT00886821|O11|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443561|NCT00886821|O10|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443562|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443563|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443564|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443565|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443566|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443567|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443568|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443569|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443570|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443571|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443572|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443573|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443574|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443575|NCT00886821|O12|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443576|NCT00886821|O11|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443577|NCT00886821|O10|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443578|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443579|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443580|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443581|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443582|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443583|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443584|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443585|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443586|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443587|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443588|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443589|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443590|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443591|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443592|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443593|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443594|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443595|NCT00886821|E14|Reported Event|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
443596|NCT00886821|E13|Reported Event|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
443597|NCT00886821|E12|Reported Event|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
443598|NCT00886821|E11|Reported Event|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
443599|NCT00886821|E10|Reported Event|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
443600|NCT00886821|E9|Reported Event|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
443601|NCT00886821|E8|Reported Event|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
443602|NCT00886821|E7|Reported Event|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
443603|NCT00886821|E6|Reported Event|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
443604|NCT00886821|E5|Reported Event|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
443605|NCT00886821|E4|Reported Event|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
443606|NCT00886821|E3|Reported Event|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
443607|NCT00886821|E2|Reported Event|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
443608|NCT00886821|E1|Reported Event|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
443609|NCT00886795|B1|Baseline|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
443642|NCT00886743|P1|Participant Flow|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443610|NCT00886795|P1|Participant Flow|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
443611|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks."
443612|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
443613|NCT00886795|E1|Reported Event|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
443614|NCT00886769|B3|Baseline|Total|Total of all reporting groups
443615|NCT00886769|B2|Baseline|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443616|NCT00886769|B1|Baseline|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443617|NCT00886769|P2|Participant Flow|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443618|NCT00886769|P1|Participant Flow|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443619|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443620|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443621|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443622|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443623|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443624|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443625|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443626|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443627|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443628|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443629|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443630|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443631|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443632|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443633|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443634|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443635|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443636|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443637|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443638|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443639|NCT00886769|E2|Reported Event|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
443640|NCT00886769|E1|Reported Event|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
443641|NCT00886743|B1|Baseline|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443643|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443644|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443645|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443646|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443647|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443648|NCT00886743|E1|Reported Event|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
443649|NCT00886704|B3|Baseline|Total|Total of all reporting groups
443650|NCT00886704|B2|Baseline|Convenience Drink Without EPA and DHA|
443651|NCT00886704|B1|Baseline|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
443652|NCT00886704|P2|Participant Flow|Convenience Drink Without EPA and DHA|
443653|NCT00886704|P1|Participant Flow|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
443654|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|
443655|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
443656|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|Palatability
443657|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA|Palatability
443658|NCT00886704|E2|Reported Event|Convenience Drink Without EPA and DHA|
443659|NCT00886704|E1|Reported Event|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
443660|NCT00886639|B1|Baseline|6MWT With Different Gas Mixtures|
443661|NCT00886639|P1|Participant Flow|6MWT With Different Gas Mixtures|
443662|NCT00886639|O1|Outcome|Oxygen Response|difference between 6-minute-walking test on oxygen and on medical air
443663|NCT00886639|E1|Reported Event|6MWT With Different Gas Mixtures|
443664|NCT00886626|B1|Baseline|All Participants|All enrolled participants
443665|NCT00886626|P2|Participant Flow|Control Then Exenatide|No medication control for 3-months then exenatide 5 mcg for 1-month uptitrated to 10 mcg for following 2-months
443666|NCT00886626|P1|Participant Flow|Exenatide Then Control|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months followed by control for 3-months
443667|NCT00886626|O2|Outcome|Control|No medication control for 3-months. Participants came from period 1 and period 2.
443668|NCT00886626|O1|Outcome|Exenatide|Exenatide 5 mcg for 1-month then up-titration to 10-mcg for remaining 2-months. Participants came from period 1 and period 2.
443669|NCT00886626|E2|Reported Event|Control|No medication control for 3-months.
443670|NCT00886626|E1|Reported Event|Exenatide|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.
443671|NCT00886613|B4|Baseline|Total|Total of all reporting groups
443672|NCT00886613|B3|Baseline|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
443673|NCT00886613|B2|Baseline|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
443674|NCT00886613|B1|Baseline|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
443675|NCT00886613|P3|Participant Flow|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
443676|NCT00886613|P2|Participant Flow|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
443677|NCT00886613|P1|Participant Flow|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
443678|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
443679|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
443680|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
443681|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
443682|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
443683|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
443684|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
443685|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
443686|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
443687|NCT00886613|O2|Outcome|Part A Participants - VZV Skin Reaction (72 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 72 hours.
443688|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (48 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 48 hours.
443689|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
443690|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
443691|NCT00886613|E3|Reported Event|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
443692|NCT00886613|E2|Reported Event|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
443693|NCT00886613|E1|Reported Event|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
443694|NCT00886600|B5|Baseline|Total|Total of all reporting groups
443695|NCT00886600|B4|Baseline|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443696|NCT00886600|B3|Baseline|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
443697|NCT00886600|B2|Baseline|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443698|NCT00886600|B1|Baseline|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443699|NCT00886600|P4|Participant Flow|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally twice daily (b.i.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
443700|NCT00886600|P3|Participant Flow|Losartan 100 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 100 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period:Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy).orally once daily for 2 weeks"
443701|NCT00886600|P2|Participant Flow|Losartan 50 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
443702|NCT00886600|P1|Participant Flow|Placebo / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan placebo orally once daily for 4 weeks~Combination Therapy Period: Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
443703|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443704|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
443705|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443706|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443707|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443708|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
443709|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443710|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443711|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443712|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
443713|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443714|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443715|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443716|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
443717|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443718|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443719|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443720|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
443721|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443722|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
443723|NCT00886587|B3|Baseline|Total|Total of all reporting groups
443724|NCT00886587|B2|Baseline|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443725|NCT00886587|B1|Baseline|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443726|NCT00886587|P2|Participant Flow|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443727|NCT00886587|P1|Participant Flow|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443728|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443729|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443730|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443731|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443732|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443733|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443734|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443735|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443736|NCT00886587|E2|Reported Event|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443737|NCT00886587|E1|Reported Event|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
443738|NCT00886483|B3|Baseline|Total|Total of all reporting groups
443739|NCT00886483|B2|Baseline|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
443740|NCT00886483|B1|Baseline|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
443741|NCT00886483|P2|Participant Flow|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
443742|NCT00886483|P1|Participant Flow|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
443743|NCT00886483|O2|Outcome|Sham Neurofeedback|Participants in the Sham group completing 40 treatments
443744|NCT00886483|O1|Outcome|Active Neurofeedback|All participants in the Active group completing 40 treatments
443745|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
443746|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
443747|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
443748|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
443749|NCT00886483|O2|Outcome|Sham Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Sham Neurofeedback group.
443750|NCT00886483|O1|Outcome|Active Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Neurofeedback group.
443751|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 40th treatment (n=10).
443752|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 40th treatment (n=24).
443753|NCT00886483|O2|Outcome|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
443754|NCT00886483|O1|Outcome|Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
443755|NCT00886483|E2|Reported Event|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
443756|NCT00886483|E1|Reported Event|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
443757|NCT00886340|B3|Baseline|Total|Total of all reporting groups
443758|NCT00886340|B2|Baseline|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
443759|NCT00886340|B1|Baseline|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
443760|NCT00886340|P2|Participant Flow|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
443761|NCT00886340|P1|Participant Flow|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
443762|NCT00886340|O2|Outcome|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
443763|NCT00886340|O1|Outcome|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
443764|NCT00886340|E2|Reported Event|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
443765|NCT00886340|E1|Reported Event|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
443766|NCT00886288|B3|Baseline|Total|Total of all reporting groups
443767|NCT00886288|B2|Baseline|Patients With Albuminuria Treated With Telmisartan|baseline population
443768|NCT00886288|B1|Baseline|Patients Without Albuminuria Treated With Telmisartan|baseline population
443769|NCT00886288|P2|Participant Flow|Patients With Albuminuria Treated With Telmisartan|
443770|NCT00886288|P1|Participant Flow|Patients Without Albuminuria Treated With Telmisartan|
443771|NCT00886288|O1|Outcome|Patients With Albuminuria Treated With Telmisartan|
443772|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
443773|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
443774|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
443775|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
443776|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
443777|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
443778|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
443779|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
443780|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
443781|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
443782|NCT00886288|E3|Reported Event||patients without baseline albuminuria data
443783|NCT00886288|E2|Reported Event|Patients With Albuminuria Treated With Telmisartan|
443784|NCT00886288|E1|Reported Event|Patients Without Albuminuria Treated With Telmisartan|
443785|NCT00886145|B1|Baseline|Vibration- Right Leg and No Vibration-left Leg|"The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.~At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month."
443786|NCT00886145|P1|Participant Flow|Vibration: Right Leg and No Vibration: Left Leg|"The subjects will undergo vibration intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35 Hz and 0.3 g.~In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords."
443787|NCT00886145|O2|Outcome|No Vibration- Left Leg|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
443788|NCT00886145|O1|Outcome|Vibration- Right Leg|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
443789|NCT00886145|E2|Reported Event|No Vibration-left Leg:|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
443790|NCT00886145|E1|Reported Event|Vibration- Right Leg:|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
443791|NCT00886119|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
443792|NCT00886119|P2|Participant Flow|Omafilcon A / Lotrafilcon B|Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis.
443793|NCT00886119|P1|Participant Flow|Lotrafilcon B / Omafilcon A|Lotrafilcon B multifocal contact lens worn first, with Omafilcon A multifocal contact lens worn second. Both products worn in a daily wear basis.
443795|NCT00886119|O1|Outcome|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear use
443796|NCT00886119|E2|Reported Event|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
443797|NCT00886119|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear
443798|NCT00886015|B3|Baseline|Total|Total of all reporting groups
443799|NCT00886015|B2|Baseline|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
443800|NCT00886015|B1|Baseline|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
443801|NCT00886015|P2|Participant Flow|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
443802|NCT00886015|P1|Participant Flow|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
443803|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
443804|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
443805|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
443806|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
443807|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
443808|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
443809|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
443810|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
443811|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
443812|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
443813|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
443814|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
443815|NCT00886015|E2|Reported Event|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
443816|NCT00886015|E1|Reported Event|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
443817|NCT00885846|B4|Baseline|Total|Total of all reporting groups
443818|NCT00885846|B3|Baseline|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
443819|NCT00885846|B2|Baseline|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
443820|NCT00885846|B1|Baseline|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
443821|NCT00885846|P3|Participant Flow|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
443822|NCT00885846|P2|Participant Flow|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
443823|NCT00885846|P1|Participant Flow|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
443824|NCT00885846|O3|Outcome|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
443825|NCT00885846|O2|Outcome|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
443826|NCT00885846|O1|Outcome|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
443827|NCT00885846|E3|Reported Event|Control|Wait list group; no activity at this arm. On list to start Qigong
443828|NCT00885846|E2|Reported Event|Progressive Resistance Training|Progressive resistance training: For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
443829|NCT00885846|E1|Reported Event|Qigong Therapy|Qigong therapy: For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
443830|NCT00885768|B1|Baseline|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
443831|NCT00885768|P1|Participant Flow|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
443832|NCT00885768|O1|Outcome|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
443833|NCT00885768|E1|Reported Event|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
443834|NCT00885755|B4|Baseline|Total|Total of all reporting groups
443869|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443870|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443871|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443835|NCT00885755|B3|Baseline|No Group|This group included participants who died before any on study disease assessments or post-baseline biopsies. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
443836|NCT00885755|B2|Baseline|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443837|NCT00885755|B1|Baseline|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443838|NCT00885755|P3|Participant Flow|No Group|This group included participants who died before any study disease assessments or post-baseline biopsies. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
443839|NCT00885755|P2|Participant Flow|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443840|NCT00885755|P1|Participant Flow|Group A:Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 milligrams per square meter (mg/m^2) or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on Body Surface Area (BSA) on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443841|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443842|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443872|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
444051|NCT00885352|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
443843|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443844|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443845|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443846|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443847|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443848|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443849|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443873|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443874|NCT00885742|E1|Reported Event|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443875|NCT00885703|B8|Baseline|Total|Total of all reporting groups
443986|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443987|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443850|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443851|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443852|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443853|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443854|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443855|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443856|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443896|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443857|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443858|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443859|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443860|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443861|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443862|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443863|NCT00885755|E1|Reported Event|All Participants|In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Trastuzumab was administered according to SMPC. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
443864|NCT00885742|B1|Baseline|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443865|NCT00885742|P1|Participant Flow|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443866|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443867|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
443868|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
444048|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
443876|NCT00885703|B7|Baseline|Stage 2, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443877|NCT00885703|B6|Baseline|Stage 2, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443878|NCT00885703|B5|Baseline|Stage 2, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443879|NCT00885703|B4|Baseline|Stage 1, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443880|NCT00885703|B3|Baseline|Stage 1, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443881|NCT00885703|B2|Baseline|Stage 1, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443882|NCT00885703|B1|Baseline|Stage 1, Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443883|NCT00885703|P7|Participant Flow|Stage 2, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443884|NCT00885703|P6|Participant Flow|Stage 2, Fulconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443885|NCT00885703|P5|Participant Flow|Stage 2, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
444049|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
443886|NCT00885703|P4|Participant Flow|Stage 1, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443887|NCT00885703|P3|Participant Flow|Stage 1, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443888|NCT00885703|P2|Participant Flow|Stage 1, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443889|NCT00885703|P1|Participant Flow|Stage 1, Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443890|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443891|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443892|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443893|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443894|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443895|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443975|NCT00885378|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443897|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443898|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443899|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443900|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443901|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443902|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443903|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443904|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443905|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443906|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443976|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443977|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443907|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443908|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443909|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443910|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443911|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443912|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443913|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443914|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443915|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443916|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443978|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443979|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443980|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443917|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443918|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443919|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443920|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443921|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443922|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443923|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443924|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443925|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443926|NCT00885703|O4|Outcome|Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443981|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443982|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443927|NCT00885703|O3|Outcome|Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443928|NCT00885703|O2|Outcome|Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443929|NCT00885703|O1|Outcome|Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443930|NCT00885703|O7|Outcome|Stage 2, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443931|NCT00885703|O6|Outcome|Stage 2, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443932|NCT00885703|O5|Outcome|Stage 2, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 2~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443933|NCT00885703|O4|Outcome|Stage 1, Ampho B|"Participants receive Amphotericin B followed by Fluconazole in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight"
443934|NCT00885703|O3|Outcome|Stage 1, Fluconazole 2000mg|"Participants receive Fluconazole 2000mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443935|NCT00885703|O2|Outcome|Stage 1, Fluconazole 1600mg|"Participants receive Fluconazole 1600mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443936|NCT00885703|O1|Outcome|Stage 1, Fluconazole 1200mg|"Participants receive Fluconazole 1200mg induction dose in Stage 1~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443983|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443984|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443937|NCT00885703|E7|Reported Event|Stage 2: Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant’s weight"
443938|NCT00885703|E6|Reported Event|Stage 2: 2000mg Fluconazole|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443939|NCT00885703|E5|Reported Event|Stage 2: 1600mg Fluconazole|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443940|NCT00885703|E4|Reported Event|Stage 1: Ampho B|"Participants receive Amphotericin B followed by Fluconazole~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.~Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant’s weight"
443941|NCT00885703|E3|Reported Event|Stage 1: 2000mg Fluconazole|"Participants receive Fluconazole 2000mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443942|NCT00885703|E2|Reported Event|Stage 1: 1600mg Fluconazole|"Participants receive Fluconazole 1600mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443943|NCT00885703|E1|Reported Event|Stage 1: 1200mg Fluconazole|"Participants receive Fluconazole 1200mg induction dose~Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).~Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.~Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.~Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally."
443944|NCT00885677|B3|Baseline|Total|Total of all reporting groups
443945|NCT00885677|B2|Baseline|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
443946|NCT00885677|B1|Baseline|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
443947|NCT00885677|P2|Participant Flow|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
443948|NCT00885677|P1|Participant Flow|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
443949|NCT00885677|O2|Outcome|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
443985|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443950|NCT00885677|O1|Outcome|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
443951|NCT00885677|O2|Outcome|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
443952|NCT00885677|O1|Outcome|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
443953|NCT00885677|E2|Reported Event|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
443954|NCT00885677|E1|Reported Event|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
443955|NCT00885638|B1|Baseline|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
443956|NCT00885638|P2|Participant Flow|Sitagliptin First, Then Placebo|First intervention 1 day, washout 14 days, second intervention 1 day
443957|NCT00885638|P1|Participant Flow|Placebo First, Then Sitagliptin|First intervention 1 day, washout 14 days, second intervention 1 day
443958|NCT00885638|O2|Outcome|Sitagliptin|Sitagliptin is given before ingestion of meal
443959|NCT00885638|O1|Outcome|Placebo|A placebo tablet is given before ingestion of meal
443960|NCT00885638|O2|Outcome|Sitagliptin|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for sitagliptin
443961|NCT00885638|O1|Outcome|Placebo|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for placebo
443962|NCT00885638|E1|Reported Event|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
443963|NCT00885534|B1|Baseline|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
443964|NCT00885534|P1|Participant Flow|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
443965|NCT00885534|O1|Outcome|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
443966|NCT00885534|E1|Reported Event|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
443967|NCT00885482|B1|Baseline|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
443968|NCT00885482|P1|Participant Flow|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
443969|NCT00885482|O1|Outcome|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
443970|NCT00885482|E1|Reported Event|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
443971|NCT00885378|B3|Baseline|Total|Total of all reporting groups
443972|NCT00885378|B2|Baseline|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443973|NCT00885378|B1|Baseline|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443974|NCT00885378|P2|Participant Flow|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
444050|NCT00885352|E2|Reported Event|Placebo|Placebo to sitagliptin once daily
443988|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443989|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443990|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443991|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443992|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443993|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443994|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443995|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443996|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443997|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
443998|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
443999|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
444000|NCT00885378|E2|Reported Event|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
444001|NCT00885378|E1|Reported Event|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
444002|NCT00885365|B3|Baseline|Total|Total of all reporting groups
444003|NCT00885365|B2|Baseline|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444004|NCT00885365|B1|Baseline|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444005|NCT00885365|P2|Participant Flow|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444006|NCT00885365|P1|Participant Flow|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444007|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444008|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444009|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444010|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444011|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444012|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444013|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444014|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444015|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444016|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444017|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444018|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444019|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444020|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444021|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444022|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444023|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444024|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444025|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444026|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444027|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444028|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444029|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444030|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444031|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444032|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444033|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444034|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444035|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444036|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444037|NCT00885365|E2|Reported Event|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
444038|NCT00885365|E1|Reported Event|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
444039|NCT00885352|B3|Baseline|Total|Total of all reporting groups
444040|NCT00885352|B2|Baseline|Placebo|Placebo to sitagliptin once daily
444041|NCT00885352|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily
444042|NCT00885352|P2|Participant Flow|Placebo|Placebo to sitagliptin once daily
444043|NCT00885352|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily
444044|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
444045|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
444046|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
444047|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
444053|NCT00885170|B2|Baseline|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444054|NCT00885170|B1|Baseline|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444055|NCT00885170|P2|Participant Flow|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444056|NCT00885170|P1|Participant Flow|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444057|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444058|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444059|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444060|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444061|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444062|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444063|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444064|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444065|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444066|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444067|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444068|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444069|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444070|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444071|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444072|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444073|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444074|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444075|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444156|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444157|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444158|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444076|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444077|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444078|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444079|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444080|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444081|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444082|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444083|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444084|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444085|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444086|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444087|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444088|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444089|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444090|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444091|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444092|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444093|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444094|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444095|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444096|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444097|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444098|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444099|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444100|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444101|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444102|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444103|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444104|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444105|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444106|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444107|NCT00885170|E2|Reported Event|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444108|NCT00885170|E1|Reported Event|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
444109|NCT00885118|B6|Baseline|Total|Total of all reporting groups
444110|NCT00885118|B5|Baseline|Empa 25 mg|Treatment with Empa 25 mg once daily
444111|NCT00885118|B4|Baseline|Empa 10 mg|Treatment with Empa 10 mg once daily
444112|NCT00885118|B3|Baseline|Empa 5 mg|Treatment with Empa 5 mg once daily
444113|NCT00885118|B2|Baseline|Empa 1 mg|Treatment with Empa 1 mg once daily
444114|NCT00885118|B1|Baseline|Placebo|Treatment with placebo once daily
444115|NCT00885118|P5|Participant Flow|Empa 25 mg|Treatment with Empa 25 mg once daily
444116|NCT00885118|P4|Participant Flow|Empa 10 mg|Treatment with Empa 10 mg once daily
444117|NCT00885118|P3|Participant Flow|Empa 5 mg|Treatment with Empa 5 mg once daily
444118|NCT00885118|P2|Participant Flow|Empa 1 mg|Treatment with Empa 1 mg once daily
444119|NCT00885118|P1|Participant Flow|Placebo|Treatment with placebo once daily
444120|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444121|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444122|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444123|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444124|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444125|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444126|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444127|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444128|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444129|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444130|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444131|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444132|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444133|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444134|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444135|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444136|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444137|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444138|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444139|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444140|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444141|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444142|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444143|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444144|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444145|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444146|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444147|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444148|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444149|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444150|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444151|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444152|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444153|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444154|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444155|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444159|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444160|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444161|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444162|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444163|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444164|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444165|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444166|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444167|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444168|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444169|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444170|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444171|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444172|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444173|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444174|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444175|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444176|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444177|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444178|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444179|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444180|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444181|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444182|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444183|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444184|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444185|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444186|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444187|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444188|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444189|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444190|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444191|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444192|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444193|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444194|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444195|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444196|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444197|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444198|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444199|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444200|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444201|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444202|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444203|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444204|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444205|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444206|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444207|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444208|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444209|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444210|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444211|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444212|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444213|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444214|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444215|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444216|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444217|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444218|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444219|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444220|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444221|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444222|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444223|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444224|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444225|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444226|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444227|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444228|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444229|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444230|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444231|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444232|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444233|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444234|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444235|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444236|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444237|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444238|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444239|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444240|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444241|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444242|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444243|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444244|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444245|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
444246|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
444247|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
444248|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
444249|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
444250|NCT00885118|E5|Reported Event|Empa 25 mg|Treatment with Empa 25 mg once daily
444251|NCT00885118|E4|Reported Event|Empa 10 mg|Treatment with Empa 10 mg once daily
444252|NCT00885118|E3|Reported Event|Empa 5 mg|Treatment with Empa 5 mg once daily
444253|NCT00885118|E2|Reported Event|Empa 1 mg|Treatment with Empa 1 mg once daily
444254|NCT00885118|E1|Reported Event|Placebo|Treatment with placebo once daily
444255|NCT00885105|B3|Baseline|Total|Total of all reporting groups
444256|NCT00885105|B2|Baseline|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444257|NCT00885105|B1|Baseline|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444258|NCT00885105|P2|Participant Flow|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444259|NCT00885105|P1|Participant Flow|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444260|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444261|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444262|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444263|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444264|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444265|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444266|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444267|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444268|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444269|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444270|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444271|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444272|NCT00885105|E2|Reported Event|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444273|NCT00885105|E1|Reported Event|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
444274|NCT00885092|B3|Baseline|Total|Total of all reporting groups
444275|NCT00885092|B2|Baseline|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
444276|NCT00885092|B1|Baseline|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
444277|NCT00885092|P2|Participant Flow|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
444362|NCT00884832|E2|Reported Event|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444278|NCT00885092|P1|Participant Flow|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
444279|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
444280|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
444281|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
444282|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
444283|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
444284|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
444285|NCT00885092|E2|Reported Event|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
444286|NCT00885092|E1|Reported Event|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
444287|NCT00885079|B3|Baseline|Total|Total of all reporting groups
444288|NCT00885079|B2|Baseline|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
444289|NCT00885079|B1|Baseline|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
444290|NCT00885079|P2|Participant Flow|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
444291|NCT00885079|P1|Participant Flow|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
444292|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
444293|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
444294|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
444295|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
444296|NCT00885079|E2|Reported Event|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
444297|NCT00885079|E1|Reported Event|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
444298|NCT00884949|B1|Baseline|BMN 110|Dose-Escalation Period:
444299|NCT00884949|P1|Participant Flow|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
444300|NCT00884949|O5|Outcome|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
444301|NCT00884949|O4|Outcome|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
444302|NCT00884949|O3|Outcome|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
444303|NCT00884949|O2|Outcome|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
444304|NCT00884949|O1|Outcome|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
444305|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
444325|NCT00884897|O2|Outcome|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
444464|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate group
444306|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
444307|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
444308|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
444309|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
444310|NCT00884949|E5|Reported Event|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
444311|NCT00884949|E4|Reported Event|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
444312|NCT00884949|E3|Reported Event|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
444313|NCT00884949|E2|Reported Event|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
444314|NCT00884949|E1|Reported Event|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
444315|NCT00884910|B1|Baseline|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
444316|NCT00884910|P1|Participant Flow|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
444317|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
444318|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
444319|NCT00884910|E1|Reported Event|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
444320|NCT00884897|B3|Baseline|Total|Total of all reporting groups
444321|NCT00884897|B2|Baseline|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
444322|NCT00884897|B1|Baseline|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
444323|NCT00884897|P2|Participant Flow|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
444324|NCT00884897|P1|Participant Flow|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
444465|NCT00884377|O4|Outcome|Study Day 10: ThermoMed|Day 10: ThermoMed group
444326|NCT00884897|O1|Outcome|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
444327|NCT00884897|O2|Outcome|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
444328|NCT00884897|O1|Outcome|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
444329|NCT00884897|E2|Reported Event|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
444330|NCT00884897|E1|Reported Event|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
444331|NCT00884832|B3|Baseline|Total|Total of all reporting groups
444332|NCT00884832|B2|Baseline|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444333|NCT00884832|B1|Baseline|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444334|NCT00884832|P2|Participant Flow|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444335|NCT00884832|P1|Participant Flow|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444336|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444337|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444338|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444339|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444340|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444341|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444342|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444343|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444344|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444345|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444346|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444347|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444348|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444349|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444350|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444351|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444352|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444353|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444354|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444355|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444356|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444357|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444358|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444359|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444360|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
444361|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444363|NCT00884832|E1|Reported Event|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
444364|NCT00884806|B1|Baseline|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
444365|NCT00884806|P1|Participant Flow|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
444366|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
444367|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
444368|NCT00884806|E1|Reported Event|FID 114675A|Investigational multi-purpose contact lens solution
444369|NCT00884793|B1|Baseline|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
444370|NCT00884793|P1|Participant Flow|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
444371|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
444372|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
444373|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
444374|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
444375|NCT00884793|E1|Reported Event|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
444376|NCT00884754|B3|Baseline|Total|Total of all reporting groups
444377|NCT00884754|B2|Baseline|90º Curvature, Malleable Stylet|
444378|NCT00884754|B1|Baseline|Rigid GlideScope Specific Stylet|
444379|NCT00884754|P2|Participant Flow|90º Curvature, Malleable Stylet|
444380|NCT00884754|P1|Participant Flow|Rigid GlideScope Specific Stylet|
444381|NCT00884754|O2|Outcome|90º Curvature, Malleable Stylet|
444382|NCT00884754|O1|Outcome|Rigid GlideScope Specific Stylet|
444383|NCT00884754|E2|Reported Event|90º Curvature, Malleable Stylet|
444384|NCT00884754|E1|Reported Event|Rigid GlideScope Specific Stylet|
444385|NCT00884741|B4|Baseline|Total|Total of all reporting groups
444386|NCT00884741|B3|Baseline|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
444387|NCT00884741|B2|Baseline|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
444388|NCT00884741|B1|Baseline|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
444389|NCT00884741|P4|Participant Flow|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
444390|NCT00884741|P3|Participant Flow|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
444391|NCT00884741|P2|Participant Flow|Step 2 Registration: Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization
444392|NCT00884741|P1|Participant Flow|Step 1 Registration|No treatment. Central Pathology Tissue Screening to confirm histology and adequacy of tissue for MGMT analysis and molecular profile. Tumor tissue must be received and central review confirmation completed before STEP 2 registration can occur.
444393|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
444394|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
444395|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
444396|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
444397|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
444398|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
444399|NCT00884741|E3|Reported Event|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
444400|NCT00884741|E2|Reported Event|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
444401|NCT00884741|E1|Reported Event|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
444402|NCT00884611|B1|Baseline|Predictive Suspend|Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.
444403|NCT00884611|P1|Participant Flow|Predictive Suspend|Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.
444404|NCT00884611|O6|Outcome|Algorithm 3 - Intervention Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444405|NCT00884611|O5|Outcome|Algorithm 3 - Control Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444406|NCT00884611|O4|Outcome|Algorithm 2 - Intervention Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444407|NCT00884611|O3|Outcome|Algorithm 2 - Control Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444408|NCT00884611|O2|Outcome|Algorithm 1 - Intervention Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444409|NCT00884611|O1|Outcome|Algorithm 1 - Control Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444410|NCT00884611|O6|Outcome|Algorithm 3 - Intervention Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444411|NCT00884611|O5|Outcome|Algorithm 3 - Control Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444412|NCT00884611|O4|Outcome|Algorithm 2 - Intervention Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444427|NCT00884585|P2|Participant Flow|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
444413|NCT00884611|O3|Outcome|Algorithm 2 - Control Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444414|NCT00884611|O2|Outcome|Algorithm 1 - Intervention Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444415|NCT00884611|O1|Outcome|Algorithm 1 - Control Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444416|NCT00884611|O6|Outcome|Algorithm 3 - Intervention Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444417|NCT00884611|O5|Outcome|Algorithm 3 - Control Nights|"Algorithm 3 had a hypoglycaemic prediction horizon of 30 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444418|NCT00884611|O4|Outcome|Algorithm 2 - Intervention Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444419|NCT00884611|O3|Outcome|Algorithm 2 - Control Nights|"Algorithm 2 had a hypoglycaemic prediction horizon of 50 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444420|NCT00884611|O2|Outcome|Algorithm 1 - Intervention Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444421|NCT00884611|O1|Outcome|Algorithm 1 - Control Nights|"Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes.~Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night."
444422|NCT00884611|E2|Reported Event|Intervention Night (PLGS Algorithm ON)|"Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.~Data for intervention nights are reported in this group."
444423|NCT00884611|E1|Reported Event|Control Night (PLGS Algorithm OFF)|"Participants had continuous glucose monitoring (CGM) using a glucose sensor and received insulin from an insulin pump during sleep. On intervention nights, participants received insulin uising an algorithm that allowed a computer to assess the data received from the CGM sensor and suspend insulin delivery to avoid potential hypoglycaemia. On control night, participants received insulin delivery as normally received by the insulin pump. Participants had 2 intervention nights to each control night.~Data for control night are reported in this group."
444424|NCT00884585|B3|Baseline|Total|Total of all reporting groups
444425|NCT00884585|B2|Baseline|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
444426|NCT00884585|B1|Baseline|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
444463|NCT00884377|O2|Outcome|ThermoMed Device|ThermoMed device group
444428|NCT00884585|P1|Participant Flow|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
444429|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
444430|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
444431|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
444432|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
444433|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
444434|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
444435|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
444436|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
444437|NCT00884585|E2|Reported Event|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
444438|NCT00884585|E1|Reported Event|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
444439|NCT00884390|B3|Baseline|Total|Total of all reporting groups
444440|NCT00884390|B2|Baseline|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
444441|NCT00884390|B1|Baseline|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
444442|NCT00884390|P2|Participant Flow|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
444443|NCT00884390|P1|Participant Flow|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
444444|NCT00884390|O1|Outcome|All Participants With at Least One Prophylaxis Infusion|All enrolled participants with at least one prophylaxis infusion
444445|NCT00884390|O1|Outcome|All Participants With at Least One Bleed|All enrolled participants with at least one bleed.
444446|NCT00884390|O2|Outcome|Participants Following a Prophylaxis Regimen at Baseline|All enrolled participants following a prophylaxis regimen at baseline
444447|NCT00884390|O1|Outcome|Participants Following a Non-prophylaxis Regimen at Baseline|All enrolled participants following an on-demand or preventive regimen at baseline
444448|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
444449|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
444450|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
444451|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
444452|NCT00884390|O1|Outcome|All Participants With Bleeds|Includes any infusion with an associated bleeding episode, regardless of the reason for treatment indicated on the case report form
444453|NCT00884390|O1|Outcome|First Infusion Per Bleed|Includes the first infusion for an associated bleeding episode
444454|NCT00884390|O1|Outcome|Annualized Bleed Rate|ABR by regimen at baseline is summarized for all participants for on-demand regimen, preventive regimen and prophylaxis regimen, respectively
444455|NCT00884390|O2|Outcome|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
444456|NCT00884390|O1|Outcome|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
444457|NCT00884390|E1|Reported Event|All Participants|The primary safety analysis was performed on all subjects who received at least 1 dose of ReFacto AF.
444458|NCT00884377|B3|Baseline|Total|Total of all reporting groups
444459|NCT00884377|B2|Baseline|Treatment With Thermomed Device|Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
444460|NCT00884377|B1|Baseline|Treatment With IV Sodium Stibogluconate|Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
444461|NCT00884377|P2|Participant Flow|Treatment With Thermomed Device|Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
444462|NCT00884377|P1|Participant Flow|Treatment With IV Sodium Stibogluconate|Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
444466|NCT00884377|O3|Outcome|Study Day 1: ThermoMed|Day 1: TherrmoMed group
444467|NCT00884377|O2|Outcome|Study Day 10: Sodium Stibogluconate|Day 10: Sodium Stibogluconate group
444468|NCT00884377|O1|Outcome|Study Day 1: Sodium Stibogluconate|Day 1: Sodium Stibogluconate group
444469|NCT00884377|O4|Outcome|Study Day 10: ThermoMed|Day 10: ThermoMed group
444470|NCT00884377|O3|Outcome|Study Day 1: ThermoMed|Day 1: TherrmoMed group
444471|NCT00884377|O2|Outcome|Study Day 10: Sodium Stibogluconate|Day 10: Sodium Stibogluconate group
444472|NCT00884377|O1|Outcome|Study Day 1: Sodium Stibogluconate|Day 1: Sodium Stibogluconate group
444473|NCT00884377|O2|Outcome|ThermoMed Treatment|ThermoMed Treatment Groups
444474|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate Groups
444475|NCT00884377|O2|Outcome|ThermoMed Device|ThermoMed device group
444476|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate group
444477|NCT00884377|O2|Outcome|ThermoMed Device|ThermoMed device group
444478|NCT00884377|O1|Outcome|Sodium Stibogluconate|Sodium Stibogluconate group
444479|NCT00884377|E2|Reported Event|ThermoMed Device|"ThermoMed device, single heat treatment at 50 degrees Celsius~ThermoMed: ThermoMed heat treatment device, one treatment"
444480|NCT00884377|E1|Reported Event|Sodium Stibogluconate Intravenous|"20 mg/kg/day Sodium stibogluconate intravenous~Sodium stibogluconate (Pentostam): intravenous 20 mg/kg/day for 10 days"
444481|NCT00884325|B3|Baseline|Total|Total of all reporting groups
444482|NCT00884325|B2|Baseline|Subjects Receiving Placebo|
444483|NCT00884325|B1|Baseline|Subjects Receiving Xyzal|
444484|NCT00884325|P2|Participant Flow|Subjects Receiving Placebo|one tablet taken orally at night for 28 days
444485|NCT00884325|P1|Participant Flow|Subjects Receiving Xyzal|one tablet, 5 mg, taken orally at night for 28 days
444486|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
444487|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
444488|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
444489|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
444490|NCT00884325|E2|Reported Event|Subjects Receiving Placebo|
444491|NCT00884325|E1|Reported Event|Subjects Receiving Xyzal|
444492|NCT00884312|B3|Baseline|Total|Total of all reporting groups
444493|NCT00884312|B2|Baseline|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444494|NCT00884312|B1|Baseline|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444495|NCT00884312|P2|Participant Flow|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444496|NCT00884312|P1|Participant Flow|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444497|NCT00884312|O2|Outcome|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444498|NCT00884312|O1|Outcome|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444499|NCT00884312|O2|Outcome|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444500|NCT00884312|O1|Outcome|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444501|NCT00884312|O2|Outcome|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444502|NCT00884312|O1|Outcome|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444908|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444503|NCT00884312|O2|Outcome|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444504|NCT00884312|O1|Outcome|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444505|NCT00884312|O2|Outcome|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444506|NCT00884312|O1|Outcome|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444507|NCT00884312|E2|Reported Event|Multiple Myeloma|Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444508|NCT00884312|E1|Reported Event|Solid Tumors|Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
444509|NCT00884286|B3|Baseline|Total|Total of all reporting groups
444510|NCT00884286|B2|Baseline|Aplidin® (Cohort Other Lymphoma)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444511|NCT00884286|B1|Baseline|Aplidin® (Cohort Non-cutaneous)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444512|NCT00884286|P2|Participant Flow|Aplidin®(Other Lymphoma)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444513|NCT00884286|P1|Participant Flow|Aplidin® (Cohort Non-cutaneous PTCL)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444514|NCT00884286|O1|Outcome|Arm One|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444515|NCT00884286|O1|Outcome|Arm One|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444516|NCT00884286|O2|Outcome|Arm One (Subset of Treated Patients With Other Lymphomas)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444517|NCT00884286|O1|Outcome|Arm One (Non-cutaneous PTCL Cohort)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444518|NCT00884286|O1|Outcome|Arm One|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444519|NCT00884286|O1|Outcome|Arm One (Non-cutaneous PTCL Cohort)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444520|NCT00884286|O1|Outcome|Arm One (Non-cutaneous PTCL Cohort)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444521|NCT00884286|O1|Outcome|Arm One|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444522|NCT00884286|E2|Reported Event|Aplidin® (Cohort Other Lymphomas)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444523|NCT00884286|E1|Reported Event|Aplidin® (Cohort Non-cutaneous PTCL)|"Aplidin® given as a 1-hour weekly IV infusion~Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle."
444524|NCT00884273|B3|Baseline|Total|Total of all reporting groups
444525|NCT00884273|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444706|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444526|NCT00884273|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444527|NCT00884273|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444528|NCT00884273|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444529|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444530|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444531|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444532|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444533|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444534|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444535|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444536|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444537|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444538|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444539|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444540|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444541|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444542|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444909|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444543|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444544|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444545|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444546|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444547|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444548|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444549|NCT00884273|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
444550|NCT00884273|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
444551|NCT00884221|B3|Baseline|Total|Total of all reporting groups
444552|NCT00884221|B2|Baseline|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444553|NCT00884221|B1|Baseline|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444554|NCT00884221|P2|Participant Flow|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
444555|NCT00884221|P1|Participant Flow|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
444556|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444557|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444707|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444558|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444559|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444560|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444561|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444562|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444563|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444564|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444565|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444566|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444567|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444568|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444569|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444570|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444571|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444572|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444573|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444574|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444575|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444576|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444577|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444578|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444579|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444580|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444581|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444582|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444583|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444584|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444708|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444910|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444585|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
444586|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444587|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444588|NCT00884221|E2|Reported Event|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444589|NCT00884221|E1|Reported Event|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
444590|NCT00884117|B1|Baseline|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444591|NCT00884117|P1|Participant Flow|All Participants Infected With Influenza|Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, otherwise healthy/non-immunocompromised adults and children greater than or equal to (≥) 1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include healthy or immunocompromised children less than or equal to (≤) 12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444592|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444593|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444594|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444595|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444596|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444597|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444709|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444911|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444598|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444599|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444600|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444601|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444602|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444603|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444604|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444605|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444606|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444607|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444608|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444609|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444610|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444611|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444710|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444912|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444612|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444613|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444614|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444615|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444616|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444617|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444618|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444619|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444620|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444621|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444622|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444623|NCT00884117|O6|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444624|NCT00884117|O5|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444625|NCT00884117|O4|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444626|NCT00884117|O3|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444627|NCT00884117|O2|Outcome|Children 1 to 5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 1 to 5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444628|NCT00884117|O1|Outcome|Children <1 Year of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children less than (<) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 6 and 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444629|NCT00884117|O1|Outcome|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444630|NCT00884117|E2|Reported Event|Participants Not Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants not receiving oseltamivir, including no treatment or other antiviral treatment, were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444631|NCT00884117|E1|Reported Event|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
444632|NCT00884065|B3|Baseline|Total|Total of all reporting groups
444633|NCT00884065|B2|Baseline|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444634|NCT00884065|B1|Baseline|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444635|NCT00884065|P2|Participant Flow|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444636|NCT00884065|P1|Participant Flow|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444637|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444638|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444639|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444640|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444641|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444642|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444643|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444644|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444645|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444646|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444647|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444648|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444649|NCT00884065|E2|Reported Event|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
444650|NCT00884065|E1|Reported Event|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
444651|NCT00884039|B3|Baseline|Total|Total of all reporting groups
444652|NCT00884039|B2|Baseline|15 mg Anecortave Acetate|
444653|NCT00884039|B1|Baseline|30 mg Anecortave Acetate|
444654|NCT00884039|P2|Participant Flow|15 mg Anecortave Acetate|
444655|NCT00884039|P1|Participant Flow|30 mg Anecortave Acetate|
444656|NCT00884039|O2|Outcome|15 mg Anecortave Acetate|
444657|NCT00884039|O1|Outcome|30 mg Anecortave Acetate|
444658|NCT00884039|E2|Reported Event|15 mg Anecortave Acetate|
444659|NCT00884039|E1|Reported Event|30 mg Anecortave Acetate|
444660|NCT00883779|B3|Baseline|Total|Total of all reporting groups
444711|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444712|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444661|NCT00883779|B2|Baseline|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444662|NCT00883779|B1|Baseline|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444663|NCT00883779|P2|Participant Flow|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 milligrams per day (mg/day) from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444664|NCT00883779|P1|Participant Flow|Placebo|Participants received 1250 milligrams per squared meter (mg/m^2) of gemcitabine intravenous (IV) infusion on Day 1 and 8, carboplatin 5 times (5x) area under concentration versus time curve (AUC) or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day Cycle) until disease progression (PD), unacceptable toxicity or death in primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444665|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444666|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444667|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444668|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444713|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444669|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444670|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444671|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444672|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444673|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444674|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444675|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444676|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444714|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444913|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444677|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444678|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444679|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444680|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444681|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444682|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444683|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444684|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444715|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444914|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444685|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444686|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444687|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444688|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444689|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444690|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444691|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444692|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444716|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444915|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444693|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444694|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444695|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444696|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444697|NCT00883779|E2|Reported Event|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
444698|NCT00883779|E1|Reported Event|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
444699|NCT00883753|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444700|NCT00883753|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444701|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444702|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444703|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444704|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444705|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444717|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444718|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444719|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444720|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444721|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444722|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444723|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444724|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444725|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444726|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444727|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444728|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444729|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444730|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444731|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444732|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444733|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444734|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444735|NCT00883753|O3|Outcome|Tocilizumab + > 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking more than one DMARD at Core study Baseline.
444736|NCT00883753|O2|Outcome|Tocilizumab + 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking one DMARD at Core study Baseline.
444737|NCT00883753|O1|Outcome|Tocilizumab Monotherapy|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were not taking DMARDS at Core Baseline.
444738|NCT00883753|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
444739|NCT00883740|B1|Baseline|Entire Study Population|Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention
444740|NCT00883740|P2|Participant Flow|Pregabalin, Then Placebo|Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
444741|NCT00883740|P1|Participant Flow|Placebo, Then Pregabalin|Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
444742|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444743|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444744|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444745|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444746|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444747|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444748|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444749|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444750|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444751|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444752|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444753|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444754|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444755|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444756|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444757|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444758|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444759|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444760|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444761|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444762|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444763|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444764|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444765|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444766|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444767|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444768|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444769|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444770|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444771|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444772|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444773|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444774|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444775|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444776|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444777|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444778|NCT00883740|E2|Reported Event|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444779|NCT00883740|E1|Reported Event|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
444780|NCT00883675|B1|Baseline|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
444781|NCT00883675|P1|Participant Flow|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
444782|NCT00883675|O1|Outcome|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
444783|NCT00883675|E1|Reported Event|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
444784|NCT00883558|B1|Baseline|All Randomized Participants|"Following a 1-month titration period, participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump."
444785|NCT00883558|P3|Participant Flow|Insulin Lispro First, Then INSULIN-PH20 NP|"Following a 1-month dose titration period, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
444786|NCT00883558|P2|Participant Flow|INSULIN-PH20 NP First, Then Insulin Lispro|"Following a 1-month dose titration period, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~INSULIN-PH20 NP (Treatment A): 100 units per milliliter (U/mL) non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
444787|NCT00883558|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a 1-month dose titration period.~Insulin Lispro (Titration Period): 100 units per milliliter (U/mL), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 1 month.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
444788|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444789|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444790|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444791|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444792|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444793|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444794|NCT00883558|E2|Reported Event|Insulin Lispro Treatment Period|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444795|NCT00883558|E1|Reported Event|INSULIN-PH20 NP Treatment Period|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
444796|NCT00883493|B3|Baseline|Total|Total of all reporting groups
444907|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444797|NCT00883493|B2|Baseline|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444798|NCT00883493|B1|Baseline|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444799|NCT00883493|P2|Participant Flow|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444800|NCT00883493|P1|Participant Flow|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444801|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444802|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444803|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444804|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444805|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444806|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444807|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444808|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444809|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444810|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444811|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444812|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444813|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444814|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444815|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444816|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444817|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444818|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444819|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444820|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444821|NCT00883493|E2|Reported Event|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
444822|NCT00883493|E1|Reported Event|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
444823|NCT00883389|B1|Baseline|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
444824|NCT00883389|P1|Participant Flow|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
444825|NCT00883389|O1|Outcome|Med-alert Pilot Group|Participants in pilot study assigned a med-alert device of bracelet or necklace
444826|NCT00883389|E1|Reported Event|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
444827|NCT00883337|B4|Baseline|Total|Total of all reporting groups
444828|NCT00883337|B3|Baseline|IFNβ1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
444829|NCT00883337|B2|Baseline|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
444830|NCT00883337|B1|Baseline|Teriflunomide 7 mg / 14 mg|"Core treatment period: Teriflunomide 7 mg once daily~Extension treatment period: Teriflunomide 14 mg once daily"
444831|NCT00883337|P3|Participant Flow|IFN-β-1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
444832|NCT00883337|P2|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
444833|NCT00883337|P1|Participant Flow|Teriflunomide 7 mg/14 mg|"Core treatment period: Teriflunomide 7 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
444834|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
444835|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
444836|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
444837|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
444838|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
444839|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
444840|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
444841|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
444842|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
444843|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
444844|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
444845|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
444846|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
444847|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
444848|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
444849|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
444850|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
444851|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
444852|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
444853|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
444854|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
444855|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
444856|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
444857|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
444858|NCT00883337|E6|Reported Event|Extended Treatment: Teriflunomide 14 mg (After IFN-β-1a)|Teriflunomide 14 mg once daily in extended treatment period after Interferon β-1a 3 times a week in core treatment period (mean exposure of 1000.03 days).
444859|NCT00883337|E5|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 14 mg)|Teriflunomide 14 mg once daily in extended treatment period after 14 mg in core treatment period (mean exposure of 1015.32 days).
444860|NCT00883337|E4|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 7 mg)|Teriflunomide 14 mg once daily in extended treatment period after 7 mg in the core treatment period (mean exposure of 996.76 days).
444861|NCT00883337|E3|Reported Event|Core Treatment: IFN-β-1a|Interferon β-1a 3 times a week (mean exposure of 405.18 days).
444862|NCT00883337|E2|Reported Event|Core Treatment:Teriflunomide 14 mg|Teriflunomide 14 mg once daily (mean exposure of 434.43 days).
444863|NCT00883337|E1|Reported Event|Core Treatment Period: Teriflunomide 7 mg|Teriflunomide 7 mg once daily (mean exposure of 456.62 days).
444864|NCT00883246|B1|Baseline|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444865|NCT00883246|P1|Participant Flow|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444866|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
444867|NCT00883246|O1|Outcome|CLI Subgroup|Wound healing was assessed in subjects who had Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
444868|NCT00883246|O1|Outcome|Claudicant Subjects|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
444869|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
444870|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
444871|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444872|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444873|NCT00883246|O2|Outcome|Claudicant Subgroup (One Year)|"All claudicant subjects (RCC 1-3) enrolled in this single-arm study were treated with directional atherectomy and walking distance measured at the one year follow-up visit.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444874|NCT00883246|O1|Outcome|Claudicant Subgroup (Baseline)|"All claudicant subjects enrolled in this single-arm study were treated with directional atherectomy and had walking distance measured prior to treatment.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444875|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444876|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444877|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444878|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444879|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
444880|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
444881|NCT00883246|E1|Reported Event|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
444882|NCT00883233|B5|Baseline|Total|Total of all reporting groups
444883|NCT00883233|B4|Baseline|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
444884|NCT00883233|B3|Baseline|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
444885|NCT00883233|B2|Baseline|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
444886|NCT00883233|B1|Baseline|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
444887|NCT00883233|P4|Participant Flow|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
444888|NCT00883233|P3|Participant Flow|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
444889|NCT00883233|P2|Participant Flow|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
444890|NCT00883233|P1|Participant Flow|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
444891|NCT00883233|O4|Outcome|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
444892|NCT00883233|O3|Outcome|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
444893|NCT00883233|O2|Outcome|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
444894|NCT00883233|O1|Outcome|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
444895|NCT00883233|E4|Reported Event|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
444896|NCT00883233|E3|Reported Event|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
444897|NCT00883233|E2|Reported Event|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
444898|NCT00883233|E1|Reported Event|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
444899|NCT00883181|B1|Baseline|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444900|NCT00883181|P1|Participant Flow|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444901|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444902|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444903|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444904|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444905|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444906|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445185|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
444916|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444917|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444918|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444919|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444920|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444921|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444922|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444923|NCT00883181|O2|Outcome|No ESA Use|Participants who did not receive treatment with a erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
444924|NCT00883181|O1|Outcome|Any ESA Use|Participants who received treatment with any erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
444925|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444926|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444927|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
444928|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444929|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444930|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444931|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444932|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444933|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444934|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444935|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444936|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444937|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444938|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444939|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444940|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444941|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444942|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444943|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444944|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444945|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444946|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444947|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444948|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444949|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444950|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444951|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444952|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444953|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444954|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444955|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444956|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444957|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444958|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444959|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444960|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444961|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444962|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444963|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444964|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444965|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444966|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444967|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444968|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444969|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444970|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444971|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444972|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444973|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444974|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444975|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444976|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444977|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444978|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444979|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444980|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444981|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444982|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444983|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444984|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444985|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444986|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444987|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444988|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444989|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444990|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444991|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444992|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444993|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
444994|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
444995|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
444996|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
444997|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
444998|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
444999|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445000|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445001|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445002|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445003|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445004|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445005|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445006|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445007|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445008|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445009|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445010|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445011|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445012|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445013|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445014|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445015|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445016|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445017|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445018|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445019|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445020|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445021|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445022|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445023|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445024|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445025|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445026|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445027|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445028|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445029|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445030|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445031|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445032|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445033|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445034|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445035|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445036|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445037|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445038|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445039|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445040|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445041|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445042|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445043|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445044|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445045|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445046|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445047|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445048|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445049|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445050|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445051|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445052|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445053|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445054|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445055|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445056|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445057|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445058|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445059|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445060|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445061|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445062|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445063|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445064|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445065|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445066|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445067|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445068|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445069|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445070|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445071|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445072|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445073|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445074|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445075|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445076|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445077|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445078|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445079|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445080|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445081|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445082|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445083|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445084|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445085|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445086|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445087|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445088|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445089|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445090|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445091|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445092|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445093|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445094|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445095|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445096|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
445097|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
445098|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
445099|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
445100|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
445101|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
445102|NCT00883181|E6|Reported Event|Breast Total|All Breast Cancer
445103|NCT00883181|E5|Reported Event|Breast Metastatic|Breast Cancer, Metastatic
445104|NCT00883181|E4|Reported Event|Breast Stage I-III|Breast Cancer, Stages I-III
445105|NCT00883181|E3|Reported Event|SCLC|Small Cell Lung Cancer
445106|NCT00883181|E2|Reported Event|NSCLC|Non-small Cell Lung Cancer
445107|NCT00883181|E1|Reported Event|Ovarian|Ovarian Cancer
445108|NCT00883168|B5|Baseline|Total|Total of all reporting groups
445109|NCT00883168|B4|Baseline|Placebo|placebo nasal spray
445110|NCT00883168|B3|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
445111|NCT00883168|B2|Baseline|Azelastine Hcl|azelastine HCl nasal spray
445112|NCT00883168|B1|Baseline|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
445113|NCT00883168|P4|Participant Flow|Placebo|placebo nasal spray
445114|NCT00883168|P3|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
445115|NCT00883168|P2|Participant Flow|Azelastine Hcl|azelastine HCl nasal spray
445116|NCT00883168|P1|Participant Flow|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
445117|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
445118|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
445119|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
445120|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
445121|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
445122|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
445123|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
445124|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
445125|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
445126|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
445127|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
445128|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
445129|NCT00883168|E4|Reported Event|Placebo|placebo nasal spray
445130|NCT00883168|E3|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
445131|NCT00883168|E2|Reported Event|Azelastine Hcl|azelastine HCl nasal spray
445132|NCT00883168|E1|Reported Event|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
445133|NCT00883129|B3|Baseline|Total|Total of all reporting groups
445134|NCT00883129|B2|Baseline|Cyclophosphamide Arm|"Participants will receive oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445135|NCT00883129|B1|Baseline|Mycophenolate Arm|"Participants will receive oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445136|NCT00883129|P2|Participant Flow|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445137|NCT00883129|P1|Participant Flow|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445138|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445139|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445140|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445141|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445142|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445143|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445144|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445145|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445146|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445147|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445148|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445149|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445150|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445151|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445152|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445153|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445154|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445155|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445184|NCT00883090|P1|Participant Flow|FXIII|All subjects treated with Factor XIII Concentrate (Human) (FXIII)
445156|NCT00883129|E2|Reported Event|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
445157|NCT00883129|E1|Reported Event|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
445158|NCT00883116|B3|Baseline|Total|Total of all reporting groups
445159|NCT00883116|B2|Baseline|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
445160|NCT00883116|B1|Baseline|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
445161|NCT00883116|P2|Participant Flow|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
445162|NCT00883116|P1|Participant Flow|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
445163|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
445164|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
445165|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
445166|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
445167|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
445168|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
445169|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received paclitaxel, 175 mg/m^2, given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2, given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
445170|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
445171|NCT00883116|E3|Reported Event|Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)|Participants received paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity.
445172|NCT00883116|E2|Reported Event|Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)|Participants received doxorubicin, 60 mg/m^2 given intravenously (IV) per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
445173|NCT00883116|E1|Reported Event|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
445174|NCT00883103|B3|Baseline|Total|Total of all reporting groups
445175|NCT00883103|B2|Baseline|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
445176|NCT00883103|B1|Baseline|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
445177|NCT00883103|P2|Participant Flow|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
445178|NCT00883103|P1|Participant Flow|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
445179|NCT00883103|O2|Outcome|Aqueous Gel|Aqueous gel was applied to the Q-tip and the catheter before insertion.
445180|NCT00883103|O1|Outcome|Lidocaine|Lidocaine gel was applied to the Q-tip and the catheter before insertion.
445181|NCT00883103|E2|Reported Event|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
445182|NCT00883103|E1|Reported Event|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
445183|NCT00883090|B1|Baseline|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445186|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445187|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445188|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445189|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445190|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445191|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445192|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445193|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445194|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445195|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445196|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445197|NCT00883090|E1|Reported Event|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
445198|NCT00882921|B1|Baseline|Elaprase® (0.5 mg/kg)|
445199|NCT00882921|P1|Participant Flow|Elaprase® (0.5 mg/kg)|
445200|NCT00882921|O1|Outcome|Elaprase|"Idursulfase 0.5 mg/kg Weekly~Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS."
445201|NCT00882921|O1|Outcome|Idursulfase (Elaprase) 0.5 mg/kg Weekly|Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS.
445202|NCT00882921|E1|Reported Event|Elaprase® (0.5 mg/kg)|
445203|NCT00882908|B6|Baseline|Total|Total of all reporting groups
445204|NCT00882908|B5|Baseline|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445205|NCT00882908|B4|Baseline|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445206|NCT00882908|B3|Baseline|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445207|NCT00882908|B2|Baseline|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445208|NCT00882908|B1|Baseline|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445209|NCT00882908|P5|Participant Flow|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445210|NCT00882908|P4|Participant Flow|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445211|NCT00882908|P3|Participant Flow|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445212|NCT00882908|P2|Participant Flow|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445213|NCT00882908|P1|Participant Flow|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445214|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445215|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445216|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445217|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445218|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445219|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445220|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445221|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445222|NCT00882908|O5|Outcome|All TMC435 Treatment Groups|Participants in all 4 TMC435 treatment groups combined.
445223|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445224|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445225|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445226|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445227|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445228|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445229|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445230|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445231|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445232|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445233|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445234|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445235|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445236|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445237|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445238|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445239|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445240|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445385|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445241|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445242|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445243|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445244|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445245|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445246|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445247|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445248|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445249|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445250|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445251|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445252|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445253|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445254|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445255|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445256|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445257|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445258|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445259|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445260|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445261|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445262|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445263|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445264|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445265|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445266|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445267|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445268|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445269|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445270|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445271|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445272|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445273|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445274|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445275|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445276|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445277|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445278|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445279|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445280|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445281|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445282|NCT00882908|E5|Reported Event|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
445283|NCT00882908|E4|Reported Event|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445284|NCT00882908|E3|Reported Event|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445285|NCT00882908|E2|Reported Event|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445758|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445286|NCT00882908|E1|Reported Event|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
445287|NCT00882778|B1|Baseline|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445288|NCT00882778|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445289|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445290|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445291|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445292|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445293|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445294|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445295|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445296|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445297|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445298|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445299|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445300|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445301|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445759|NCT00881335|O2|Outcome|Control Group|without any intervention
445302|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445303|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445304|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445305|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445306|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445307|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445308|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445309|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445310|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445311|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445312|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445313|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445314|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445315|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445316|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445317|NCT00882778|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
445318|NCT00882713|B1|Baseline|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445319|NCT00882713|P1|Participant Flow|C.E.R.A.|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445320|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445321|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445322|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445323|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445324|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445325|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445326|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445327|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445328|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445329|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445330|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445331|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445332|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445386|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
445333|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445334|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445335|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445336|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445337|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445338|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445339|NCT00882713|E1|Reported Event|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
445340|NCT00882687|B5|Baseline|Total|Total of all reporting groups
445341|NCT00882687|B4|Baseline|Placebo|
445342|NCT00882687|B3|Baseline|Lifitegrast 5.0%|
445343|NCT00882687|B2|Baseline|Lifitegrast 1.0%|
445344|NCT00882687|B1|Baseline|Lifitegrast 0.1%|
445345|NCT00882687|P4|Participant Flow|Placebo|
445346|NCT00882687|P3|Participant Flow|Lifitegrast 5.0%|
445347|NCT00882687|P2|Participant Flow|Lifitegrast 1.0%|
445348|NCT00882687|P1|Participant Flow|Lifitegrast 0.1%|
445349|NCT00882687|O4|Outcome|Placebo|
445350|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
445351|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
445352|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
445353|NCT00882687|O4|Outcome|Placebo|
445354|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
445355|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
445356|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
445357|NCT00882687|O4|Outcome|Placebo|
445358|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
445359|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
445360|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
445361|NCT00882687|O4|Outcome|Placebo|
445362|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
445363|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
445364|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
445365|NCT00882687|O4|Outcome|Placebo|
445366|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
445367|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
445368|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
445369|NCT00882687|O4|Outcome|Placebo|
445370|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
445371|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
445372|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
445373|NCT00882687|E4|Reported Event|Placebo|
445374|NCT00882687|E3|Reported Event|Lifitegrast 5.0%|
445375|NCT00882687|E2|Reported Event|Lifitegrast 1.0%|
445376|NCT00882687|E1|Reported Event|Lifitegrast 0.1%|
445377|NCT00882661|B4|Baseline|Total|Total of all reporting groups
445378|NCT00882661|B3|Baseline|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
445379|NCT00882661|B2|Baseline|ASSURE Cervical Plate and Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445380|NCT00882661|B1|Baseline|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445381|NCT00882661|P2|Participant Flow|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445382|NCT00882661|P1|Participant Flow|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445383|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
445384|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445387|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445388|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445389|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
445390|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445391|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445392|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
445393|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445394|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445395|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
445396|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445397|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445398|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
445399|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445400|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445401|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
445402|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445403|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445404|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
445405|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445406|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445407|NCT00882661|E2|Reported Event|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
445408|NCT00882661|E1|Reported Event|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
445409|NCT00882583|B3|Baseline|Total|Total of all reporting groups
445410|NCT00882583|B2|Baseline|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
445411|NCT00882583|B1|Baseline|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
445412|NCT00882583|P2|Participant Flow|Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma (SCC) of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
445413|NCT00882583|P1|Participant Flow|Cohort A T2N0, T1-2N1 SCCHN|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
445414|NCT00882583|O2|Outcome|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
445415|NCT00882583|O1|Outcome|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
445416|NCT00882583|E2|Reported Event|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
445417|NCT00882583|E1|Reported Event|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
445418|NCT00882557|B3|Baseline|Total|Total of all reporting groups
445419|NCT00882557|B2|Baseline|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
445420|NCT00882557|B1|Baseline|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
445421|NCT00882557|P2|Participant Flow|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
445422|NCT00882557|P1|Participant Flow|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
445423|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
445424|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
445425|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
445426|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
445427|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
445428|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
445429|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
445430|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
445431|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
445432|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
445433|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
445434|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
445435|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
445436|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
445437|NCT00882557|E2|Reported Event|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
445438|NCT00882557|E1|Reported Event|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
445439|NCT00882518|B3|Baseline|Total|Total of all reporting groups
445440|NCT00882518|B2|Baseline|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
445441|NCT00882518|B1|Baseline|Seroquel_XR|Quetiapine fumarate XR was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
445442|NCT00882518|P2|Participant Flow|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
445443|NCT00882518|P1|Participant Flow|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
445444|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445445|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445446|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445447|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445448|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445449|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445450|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445451|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445452|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445453|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445454|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445455|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445456|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445457|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445458|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445459|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445552|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445460|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
445461|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
445462|NCT00882518|E2|Reported Event|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
445463|NCT00882518|E1|Reported Event|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
445464|NCT00882440|B8|Baseline|Total|Total of all reporting groups
445465|NCT00882440|B7|Baseline|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
445466|NCT00882440|B6|Baseline|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
445467|NCT00882440|B5|Baseline|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
445468|NCT00882440|B4|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
445469|NCT00882440|B3|Baseline|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
445470|NCT00882440|B2|Baseline|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
445471|NCT00882440|B1|Baseline|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
445472|NCT00882440|P7|Participant Flow|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
445473|NCT00882440|P6|Participant Flow|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
445474|NCT00882440|P5|Participant Flow|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
445475|NCT00882440|P4|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
445476|NCT00882440|P3|Participant Flow|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
445477|NCT00882440|P2|Participant Flow|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
445478|NCT00882440|P1|Participant Flow|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
445479|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
445480|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
445481|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
445482|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
445483|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
445484|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
445485|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
445486|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
445487|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
445488|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
445489|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
445490|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
445491|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
445492|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
445493|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
445494|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
445495|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
445496|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
445497|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
445498|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
445499|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
445500|NCT00882362|B3|Baseline|Total|Total of all reporting groups
445501|NCT00882362|B2|Baseline|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
445502|NCT00882362|B1|Baseline|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
445503|NCT00882362|P2|Participant Flow|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
445504|NCT00882362|P1|Participant Flow|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
445505|NCT00882362|O2|Outcome|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
445506|NCT00882362|O1|Outcome|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
445507|NCT00882362|E2|Reported Event|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
445508|NCT00882362|E1|Reported Event|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
445553|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445509|NCT00882310|B1|Baseline|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
445510|NCT00882310|P1|Participant Flow|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
445511|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
445512|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
445513|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
445514|NCT00882310|E1|Reported Event|Gemcitabine, Docetaxel, Capecitabine GTX|"GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.~AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated)."
445515|NCT00882206|B1|Baseline|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
445516|NCT00882206|P1|Participant Flow|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
445517|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
445518|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
445519|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
445520|NCT00882206|O1|Outcome|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
445554|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445555|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445521|NCT00882206|E1|Reported Event|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12)"
445522|NCT00882102|B1|Baseline|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
445523|NCT00882102|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
445524|NCT00882102|O1|Outcome|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 by vein over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m^2 by vein on day 5.
445525|NCT00882102|E1|Reported Event|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
445526|NCT00881959|B3|Baseline|Total|Total of all reporting groups
445527|NCT00881959|B2|Baseline|Group 2: Alloderm|"Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
445528|NCT00881959|B1|Baseline|Group 1: Puros Dermis|"Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
445529|NCT00881959|P2|Participant Flow|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
445530|NCT00881959|P1|Participant Flow|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
445531|NCT00881959|O2|Outcome|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
445532|NCT00881959|O1|Outcome|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
445533|NCT00881959|E2|Reported Event|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
445534|NCT00881959|E1|Reported Event|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
445535|NCT00881894|B3|Baseline|Total|Total of all reporting groups
445536|NCT00881894|B2|Baseline|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
445537|NCT00881894|B1|Baseline|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
445538|NCT00881894|P2|Participant Flow|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
445539|NCT00881894|P1|Participant Flow|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
445540|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445541|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445542|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445543|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445544|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445545|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445546|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445547|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445548|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445549|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445550|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445551|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445556|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445557|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445558|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445559|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445560|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445561|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445562|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445563|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445564|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445565|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445566|NCT00881894|E2|Reported Event|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
445567|NCT00881894|E1|Reported Event|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
445568|NCT00881868|B3|Baseline|Total|Total of all reporting groups
445569|NCT00881868|B2|Baseline|Vehicle Spray|
445570|NCT00881868|B1|Baseline|Clobex Spray|
445571|NCT00881868|P2|Participant Flow|Vehicle Spray|
445572|NCT00881868|P1|Participant Flow|Clobex Spray|
445573|NCT00881868|O2|Outcome|Vehicle Spray|
445574|NCT00881868|O1|Outcome|Clobex Spray|
445575|NCT00881868|O2|Outcome|Vehicle Spray|
445576|NCT00881868|O1|Outcome|Clobex Spray|
445577|NCT00881868|O2|Outcome|Vehicle Spray|
445578|NCT00881868|O1|Outcome|Clobex Spray|
445579|NCT00881868|O2|Outcome|Vehicle Spray|
445580|NCT00881868|O1|Outcome|Clobex Spray|
445581|NCT00881868|E2|Reported Event|Vehicle Spray|
445582|NCT00881868|E1|Reported Event|Clobex Spray|
445583|NCT00881751|B3|Baseline|Total|Total of all reporting groups
445584|NCT00881751|B2|Baseline|Arm II|"Patients receive oral sorafenib tosylate twice daily on days 1-28.~sorafenib tosylate: Given orally"
445585|NCT00881751|B1|Baseline|Arm I|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.~bevacizumab: Given IV~erlotinib hydrochloride: Given orally"
445586|NCT00881751|P2|Participant Flow|Arm II|"Subjects who were enrolled to the sorafenib arm.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
445587|NCT00881751|P1|Participant Flow|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
445588|NCT00881751|O2|Outcome|Arm II|"Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
445589|NCT00881751|O1|Outcome|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
445590|NCT00881751|O2|Outcome|Arm II|"Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
445591|NCT00881751|O1|Outcome|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
445592|NCT00881751|O2|Outcome|Arm II|"Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
445593|NCT00881751|O1|Outcome|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
445594|NCT00881751|O2|Outcome|Arm II|"Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
445595|NCT00881751|O1|Outcome|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
445596|NCT00881751|E2|Reported Event|Arm II|"Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.~Sorafenib: oral administration on days 1-28 of a 28 day cycle"
445597|NCT00881751|E1|Reported Event|Arm I|"Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.~Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle"
445598|NCT00881712|B4|Baseline|Total|Total of all reporting groups
445679|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445599|NCT00881712|B3|Baseline|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445600|NCT00881712|B2|Baseline|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445601|NCT00881712|B1|Baseline|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445602|NCT00881712|P3|Participant Flow|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445603|NCT00881712|P2|Participant Flow|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445604|NCT00881712|P1|Participant Flow|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445605|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445606|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445607|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445608|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445609|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445610|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445611|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445612|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445613|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445614|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445615|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445616|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445617|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445618|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445619|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445620|NCT00881712|E3|Reported Event|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
445621|NCT00881712|E2|Reported Event|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
445622|NCT00881712|E1|Reported Event|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
445623|NCT00881647|B3|Baseline|Total|Total of all reporting groups
445624|NCT00881647|B2|Baseline|Waitlist|Participants placed on a waitlist for 8 weeks.
445625|NCT00881647|B1|Baseline|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
445626|NCT00881647|P2|Participant Flow|Waitlist|Participants placed on a waitlist for 8 weeks.
445627|NCT00881647|P1|Participant Flow|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
445628|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
445629|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
445630|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
445631|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
445632|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
445633|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
445634|NCT00881647|E2|Reported Event|Waitlist|Participants placed on a waitlist for 8 weeks.
445635|NCT00881647|E1|Reported Event|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
445636|NCT00881621|B1|Baseline|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
445637|NCT00881621|P1|Participant Flow|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
445638|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
445639|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
445640|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
445641|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
445642|NCT00881621|E1|Reported Event|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
445643|NCT00881608|B6|Baseline|Total|Total of all reporting groups
445644|NCT00881608|B5|Baseline|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445645|NCT00881608|B4|Baseline|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445646|NCT00881608|B3|Baseline|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445647|NCT00881608|B2|Baseline|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445648|NCT00881608|B1|Baseline|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
445649|NCT00881608|P1|Participant Flow|All Subjects Enrolled|All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
445650|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445651|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445680|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445652|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445653|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445654|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
445655|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445656|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445657|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445658|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445659|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
445660|NCT00881608|E5|Reported Event|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445661|NCT00881608|E4|Reported Event|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445662|NCT00881608|E3|Reported Event|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445663|NCT00881608|E2|Reported Event|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
445664|NCT00881608|E1|Reported Event|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
445665|NCT00881530|B7|Baseline|Total|Total of all reporting groups
445666|NCT00881530|B6|Baseline|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445667|NCT00881530|B5|Baseline|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445668|NCT00881530|B4|Baseline|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445669|NCT00881530|B3|Baseline|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445670|NCT00881530|B2|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445671|NCT00881530|B1|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445672|NCT00881530|P6|Participant Flow|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445673|NCT00881530|P5|Participant Flow|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445674|NCT00881530|P4|Participant Flow|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445675|NCT00881530|P3|Participant Flow|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445676|NCT00881530|P2|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445677|NCT00881530|P1|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445678|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445754|NCT00881335|P1|Participant Flow|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445681|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445682|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445683|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445684|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445685|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445686|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445687|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445688|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445689|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445690|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445691|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445692|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445693|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445694|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445695|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445696|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445697|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445698|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445699|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445700|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445701|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445702|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445703|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445704|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445705|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445706|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445707|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445708|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445709|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445710|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445755|NCT00881335|O2|Outcome|Control Group|without any intervention
445711|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445712|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445713|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445714|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445715|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445716|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445717|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445718|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445719|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445720|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445721|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445722|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445723|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445724|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445725|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445726|NCT00881530|E6|Reported Event|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445727|NCT00881530|E5|Reported Event|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445728|NCT00881530|E4|Reported Event|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
445729|NCT00881530|E3|Reported Event|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
445730|NCT00881530|E2|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
445731|NCT00881530|E1|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
445732|NCT00881504|B1|Baseline|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
445733|NCT00881504|P1|Participant Flow|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
445734|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
445735|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
445736|NCT00881504|E1|Reported Event|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
445737|NCT00881465|B3|Baseline|Total|Total of all reporting groups
445756|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445738|NCT00881465|B2|Baseline|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
445739|NCT00881465|B1|Baseline|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
445740|NCT00881465|P2|Participant Flow|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
445741|NCT00881465|P1|Participant Flow|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
445742|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
445743|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
445744|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
445745|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
445746|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
445747|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
445748|NCT00881465|E2|Reported Event|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
445749|NCT00881465|E1|Reported Event|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
445750|NCT00881335|B3|Baseline|Total|Total of all reporting groups
445751|NCT00881335|B2|Baseline|Control Group|without any intervention
445752|NCT00881335|B1|Baseline|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445753|NCT00881335|P2|Participant Flow|Control Group|without any intervention
445757|NCT00881335|O2|Outcome|Control Group|without any intervention
445760|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445761|NCT00881335|O2|Outcome|Control Group|without any intervention
445762|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445763|NCT00881335|O2|Outcome|Control Group|without any intervention
445764|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445765|NCT00881335|O2|Outcome|Control Group|without any intervention
445766|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445767|NCT00881335|O2|Outcome|Control Group|without any intervention
445768|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445769|NCT00881335|E2|Reported Event|Control Group|without any intervention
445770|NCT00881335|E1|Reported Event|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
445771|NCT00881205|B3|Baseline|Total|Total of all reporting groups
445772|NCT00881205|B2|Baseline|Placebo|Matching the size, shape and color of rivastigmine patches.
445773|NCT00881205|B1|Baseline|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
445774|NCT00881205|P2|Participant Flow|Placebo|Matching the size, shape and color of rivastigmine patches.
445775|NCT00881205|P1|Participant Flow|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
445776|NCT00881205|O2|Outcome|Placebo|Matching the size, shape and color of rivastigmine patches.
445777|NCT00881205|O1|Outcome|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
445778|NCT00881205|E3|Reported Event|Placebo|Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
445779|NCT00881205|E2|Reported Event|Rivastigmine|Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
445780|NCT00881205|E1|Reported Event|Total Patients|Total Patients
445781|NCT00880919|B4|Baseline|Total|Total of all reporting groups
445782|NCT00880919|B3|Baseline|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445783|NCT00880919|B2|Baseline|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445784|NCT00880919|B1|Baseline|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445785|NCT00880919|P3|Participant Flow|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445786|NCT00880919|P2|Participant Flow|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445787|NCT00880919|P1|Participant Flow|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445788|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445789|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445790|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445791|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445792|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445793|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445794|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445795|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445796|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445797|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445798|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445799|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445800|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445801|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445802|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445803|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445804|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445805|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445806|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445807|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445808|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445809|NCT00880919|O3|Outcome|Placebo (n=29)|"Equivalent number of placebo oral tablets taken daily for 8 weeks.~Placebo: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
445810|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33)|"Seroquel XR 300mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
445811|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33)|"Seroquel XR 150mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
445812|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445813|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445814|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445815|NCT00880919|E3|Reported Event|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
445816|NCT00880919|E2|Reported Event|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
445817|NCT00880919|E1|Reported Event|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
445818|NCT00880906|B3|Baseline|Total|Total of all reporting groups
445819|NCT00880906|B2|Baseline|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
445820|NCT00880906|B1|Baseline|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
445821|NCT00880906|P2|Participant Flow|Group B Drug Therapy Only|Receives steroids and PPI only- Does not have esophageal dilation.
445822|NCT00880906|P1|Participant Flow|Group A Drug Therapy Plus Dilation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
445823|NCT00880906|O2|Outcome|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
445824|NCT00880906|O1|Outcome|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
445825|NCT00880906|O2|Outcome|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
445826|NCT00880906|O1|Outcome|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
445827|NCT00880906|E2|Reported Event|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
445828|NCT00880906|E1|Reported Event|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
445829|NCT00880763|B5|Baseline|Total|Total of all reporting groups
445830|NCT00880763|B4|Baseline|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445831|NCT00880763|B3|Baseline|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445832|NCT00880763|B2|Baseline|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445833|NCT00880763|B1|Baseline|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445834|NCT00880763|P4|Participant Flow|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445835|NCT00880763|P3|Participant Flow|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445836|NCT00880763|P2|Participant Flow|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445837|NCT00880763|P1|Participant Flow|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445838|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445839|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445840|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445841|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445842|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445843|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445844|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445845|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445846|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445847|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445848|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445849|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445850|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445851|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445852|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445853|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445854|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445855|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445856|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445857|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445858|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445859|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445860|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445861|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445862|NCT00880763|E4|Reported Event|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445863|NCT00880763|E3|Reported Event|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445864|NCT00880763|E2|Reported Event|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445865|NCT00880763|E1|Reported Event|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
445866|NCT00880750|B3|Baseline|Total|Total of all reporting groups
445867|NCT00880750|B2|Baseline|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
445868|NCT00880750|B1|Baseline|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
445869|NCT00880750|P2|Participant Flow|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
445870|NCT00880750|P1|Participant Flow|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
445871|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445872|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445873|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445874|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445875|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445876|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445877|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445878|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445879|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445880|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445881|NCT00880750|E2|Reported Event|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445882|NCT00880750|E1|Reported Event|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
445883|NCT00880698|B5|Baseline|Total|Total of all reporting groups
445884|NCT00880698|B4|Baseline|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445885|NCT00880698|B3|Baseline|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445886|NCT00880698|B2|Baseline|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445887|NCT00880698|B1|Baseline|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445888|NCT00880698|P4|Participant Flow|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445889|NCT00880698|P3|Participant Flow|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445890|NCT00880698|P2|Participant Flow|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445891|NCT00880698|P1|Participant Flow|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445892|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445893|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445894|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445895|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445896|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445897|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445898|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445939|NCT00880620|O2|Outcome|IPX066 145mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
445940|NCT00880620|O1|Outcome|Placebo|Placebo capsules were used
445899|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445900|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445901|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445902|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445903|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445904|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445905|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445906|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445907|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445908|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445909|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445910|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
445911|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
445912|NCT00880698|E4|Reported Event|HIV-1 Infected Placebo|
445913|NCT00880698|E3|Reported Event|HIV-1 Infected RotaTeq|
445914|NCT00880698|E2|Reported Event|HIV-1 Uninfected Placebo|
445915|NCT00880698|E1|Reported Event|HIV-1 Uninfected RotaTeq|
445916|NCT00880685|B1|Baseline|Memantine 10mg-30mg|10mg-30mg
445917|NCT00880685|P1|Participant Flow|Memantine 10mg-30mg|10mg-30mg
445918|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
445919|NCT00880685|O1|Outcome|Memantine|"Memantine 10-30mg~Memantine: 10-30mg, daily for 8 weeks"
445920|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
445921|NCT00880685|E3|Reported Event|Memantine 30mg|30mg
445922|NCT00880685|E2|Reported Event|Memantine 20mg|20mg
445923|NCT00880685|E1|Reported Event|Memantine 10mg|10mg
445924|NCT00880620|B5|Baseline|Total|Total of all reporting groups
445925|NCT00880620|B4|Baseline|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
445926|NCT00880620|B3|Baseline|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
445927|NCT00880620|B2|Baseline|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
445928|NCT00880620|B1|Baseline|Placebo|Placebo capsules were used
445929|NCT00880620|P4|Participant Flow|IPX066 390 mg LD|IPX066 capsules that contained 390 mg levodopa and 97.5 mg carbidopa
445930|NCT00880620|P3|Participant Flow|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
445931|NCT00880620|P2|Participant Flow|IPX066 145 mg LD|IPX066 capsule containing 145 mg levodopa and 36.25 mg carbidopa
445932|NCT00880620|P1|Participant Flow|Placebo|Placebo capsules were used
445933|NCT00880620|O4|Outcome|Placebo|Placebo capsules were used
445934|NCT00880620|O3|Outcome|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
445935|NCT00880620|O2|Outcome|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
445936|NCT00880620|O1|Outcome|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
445937|NCT00880620|O4|Outcome|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
445938|NCT00880620|O3|Outcome|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
451605|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
445941|NCT00880620|E4|Reported Event|IPX066 390 mg LD|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
445942|NCT00880620|E3|Reported Event|IPX066 245 mg LD|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
445943|NCT00880620|E2|Reported Event|IPX066 145 mg LD|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
445944|NCT00880620|E1|Reported Event|Placebo|Placebo capsules were used
445945|NCT00880581|B1|Baseline|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
445946|NCT00880581|P1|Participant Flow|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 (CpG 7909 or ProMune) at 18 mg per week over 10 weeks in combination with local radiation [2 gray (2Gy) on each of Days 1 and 2] as a therapy for low-grade B-cell lymphoma.
445947|NCT00880581|O1|Outcome|PF-3512676|"Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.~PF-3512676: 18 mg injection~Local radiotherapy: 2 x 2 Gy"
445948|NCT00880581|O1|Outcome|PF-3512676|"Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.~PF-3512676: 18 mg injection~Local radiotherapy: 2 x 2 Gy"
445949|NCT00880581|E1|Reported Event|PF-3512676|Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
445950|NCT00880568|B10|Baseline|Total|Total of all reporting groups
445951|NCT00880568|B9|Baseline|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445952|NCT00880568|B8|Baseline|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445953|NCT00880568|B7|Baseline|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445954|NCT00880568|B6|Baseline|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445955|NCT00880568|B5|Baseline|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445956|NCT00880568|B4|Baseline|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
445957|NCT00880568|B3|Baseline|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
445958|NCT00880568|B2|Baseline|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
445959|NCT00880568|B1|Baseline|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
445960|NCT00880568|P9|Participant Flow|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445961|NCT00880568|P8|Participant Flow|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445962|NCT00880568|P7|Participant Flow|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445963|NCT00880568|P6|Participant Flow|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445964|NCT00880568|P5|Participant Flow|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445965|NCT00880568|P4|Participant Flow|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
445966|NCT00880568|P3|Participant Flow|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
445967|NCT00880568|P2|Participant Flow|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
445968|NCT00880568|P1|Participant Flow|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
445969|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445970|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445971|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445972|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445973|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445974|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
445975|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
445976|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
445977|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
445978|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445979|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445980|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445981|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445982|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445983|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445984|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445985|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445986|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445987|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445988|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
445989|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
445990|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
445991|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
445992|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445993|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445994|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445995|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445996|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
445997|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
445998|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
445999|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
446000|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
446001|NCT00880568|E9|Reported Event|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
446002|NCT00880568|E8|Reported Event|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
446003|NCT00880568|E7|Reported Event|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
446004|NCT00880568|E6|Reported Event|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
446005|NCT00880568|E5|Reported Event|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
446006|NCT00880568|E4|Reported Event|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
446007|NCT00880568|E3|Reported Event|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
446008|NCT00880568|E2|Reported Event|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
446009|NCT00880568|E1|Reported Event|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
446010|NCT00880555|B4|Baseline|Total|Total of all reporting groups
446011|NCT00880555|B3|Baseline|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
446012|NCT00880555|B2|Baseline|Arm 2: Control|Elderly controls without memory impairment
446013|NCT00880555|B1|Baseline|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
446014|NCT00880555|P6|Participant Flow|Non-AD Dementia|Other causes of dementia
446015|NCT00880555|P5|Participant Flow|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
446016|NCT00880555|P4|Participant Flow|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
446017|NCT00880555|P3|Participant Flow|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
446018|NCT00880555|P2|Participant Flow|Arm 2: Control|Elderly controls without memory impairment
446019|NCT00880555|P1|Participant Flow|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
446020|NCT00880555|O3|Outcome|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
446021|NCT00880555|O2|Outcome|Arm 2: Control|Elderly controls without memory impairment
446022|NCT00880555|O1|Outcome|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
446023|NCT00880555|E6|Reported Event|Non-AD Dementia|Other causes of dementia
446024|NCT00880555|E5|Reported Event|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
446025|NCT00880555|E4|Reported Event|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
446026|NCT00880555|E3|Reported Event|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
446027|NCT00880555|E2|Reported Event|Arm 2: Control|Elderly controls without memory impairment
446028|NCT00880555|E1|Reported Event|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
446029|NCT00880542|B1|Baseline|Sorafenib + Ifosfamide|
446030|NCT00880542|P1|Participant Flow|Sorafenib + Ifosfamide|
446031|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
446032|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
446033|NCT00880542|E1|Reported Event|Sorafenib + Ifosfamide|
446034|NCT00880425|B1|Baseline|Chronic Daily Headache|Patients who fulfilled criteria for Chronic Migraine, New Daily Persistent Headache , Chronic Post Traumatic Headache or Chronic Tension Type Headache
446035|NCT00880425|P2|Participant Flow|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446076|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
451606|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
446036|NCT00880425|P1|Participant Flow|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446037|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446038|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446039|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446040|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446041|NCT00880425|E2|Reported Event|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446042|NCT00880425|E1|Reported Event|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
446043|NCT00880399|B4|Baseline|Total|Total of all reporting groups
446044|NCT00880399|B3|Baseline|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446045|NCT00880399|B2|Baseline|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446046|NCT00880399|B1|Baseline|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446047|NCT00880399|P3|Participant Flow|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446048|NCT00880399|P2|Participant Flow|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446049|NCT00880399|P1|Participant Flow|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446050|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446051|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446052|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446053|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446054|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446055|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446056|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446057|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446058|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446059|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446060|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446061|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446062|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446063|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446064|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446065|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446066|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446067|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446068|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446069|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446070|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446071|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446072|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446073|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446074|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446075|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446077|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446078|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446079|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446080|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446081|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446082|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446083|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446084|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446085|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446086|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446087|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446088|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446089|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446090|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446091|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446092|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446093|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446094|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446095|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446096|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446097|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446098|NCT00880399|O3|Outcome|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446099|NCT00880399|O2|Outcome|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446100|NCT00880399|O1|Outcome|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446101|NCT00880399|E3|Reported Event|Orvepitant 60 mg|Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446102|NCT00880399|E2|Reported Event|Orvepitant 30 mg|Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
446103|NCT00880399|E1|Reported Event|Placebo|Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
446104|NCT00880360|B1|Baseline|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
446105|NCT00880360|P1|Participant Flow|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
446106|NCT00880360|O1|Outcome|Ontak|Ontak: Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
446107|NCT00880360|O1|Outcome|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
446108|NCT00880360|E1|Reported Event|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
446109|NCT00880334|B3|Baseline|Total|Total of all reporting groups
446110|NCT00880334|B2|Baseline|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
446111|NCT00880334|B1|Baseline|Vandetanib & Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
446112|NCT00880334|P2|Participant Flow|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
446113|NCT00880334|P1|Participant Flow|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
446114|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
446115|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
446116|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
446117|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
446118|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
446119|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Vandetanib: taken orally once a day, every day"
446120|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
446121|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
446122|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Placebo orally and docetaxel intravenously~Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
446123|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Vandetanib: taken orally once a day, every day"
446124|NCT00880334|E2|Reported Event|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
446125|NCT00880334|E1|Reported Event|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
446126|NCT00880269|B3|Baseline|Total|Total of all reporting groups
446127|NCT00880269|B2|Baseline|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446128|NCT00880269|B1|Baseline|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446129|NCT00880269|P2|Participant Flow|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446130|NCT00880269|P1|Participant Flow|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446131|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446132|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446133|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446134|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446135|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446136|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446137|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446138|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446139|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446140|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446141|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446142|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446143|NCT00880269|E2|Reported Event|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
446144|NCT00880269|E1|Reported Event|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
446145|NCT00880256|B1|Baseline|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
446146|NCT00880256|P1|Participant Flow|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
446147|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
446148|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
446149|NCT00880256|E1|Reported Event|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
446150|NCT00880230|B1|Baseline|Scuba Iliac Stent System|"Device: Scuba™ Iliac stent~Scuba Iliac Stent System: The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446151|NCT00880230|P1|Participant Flow|Scuba Iliac Stent System|"Device: Scuba Iliac Stent~Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446152|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446153|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
451607|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
446154|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446155|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446156|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446157|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446158|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446159|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446160|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446161|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446162|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446163|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446164|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446165|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446166|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446167|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446168|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446169|NCT00880230|E1|Reported Event|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
446170|NCT00880191|B3|Baseline|Total|Total of all reporting groups
446171|NCT00880191|B2|Baseline|Placebo|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > placebo: Given orally
446172|NCT00880191|B1|Baseline|Gabapentin|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > gabapentin: Given orally
446173|NCT00880191|P2|Participant Flow|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
446174|NCT00880191|P1|Participant Flow|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446175|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
446176|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446177|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
446178|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446179|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
451608|NCT00864513|E1|Reported Event|Chemotherapy|pemetrexed
446180|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446181|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
446182|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446183|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
446184|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446185|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
446186|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446187|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
446188|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
446189|NCT00880191|E2|Reported Event|Placebo|placebo: Given orally
446190|NCT00880191|E1|Reported Event|Gabapentin|gabapentin: Given orally
446191|NCT00880165|B3|Baseline|Total|Total of all reporting groups
446192|NCT00880165|B2|Baseline|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446193|NCT00880165|B1|Baseline|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446194|NCT00880165|P2|Participant Flow|Home Unattended Testing|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
446195|NCT00880165|P1|Participant Flow|In-laboratory Testing|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
446196|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446197|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446198|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446199|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446200|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446201|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446202|NCT00880165|E2|Reported Event|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446203|NCT00880165|E1|Reported Event|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
446204|NCT00880100|B1|Baseline|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446205|NCT00880100|P1|Participant Flow|Ultrase® MT12|Patients received usual pancreatic enzymes therapy for 9 to 14 days during baseline phase followed by Ultrase® MT12 capsules orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446206|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446207|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446208|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446209|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446210|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446211|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446212|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446213|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446214|NCT00880100|E1|Reported Event|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
446215|NCT00880048|B4|Baseline|Total|Total of all reporting groups
446216|NCT00880048|B3|Baseline|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446217|NCT00880048|B2|Baseline|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446218|NCT00880048|B1|Baseline|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446219|NCT00880048|P3|Participant Flow|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446220|NCT00880048|P2|Participant Flow|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446221|NCT00880048|P1|Participant Flow|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446222|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446223|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446224|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446225|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446226|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446227|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446228|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446229|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446230|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446231|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446232|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446233|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446234|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446235|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446236|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446237|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
451609|NCT00864383|B4|Baseline|Total|Total of all reporting groups
446238|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446239|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446240|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446241|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446242|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446243|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446244|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446245|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446246|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446247|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446248|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446249|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446250|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446251|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446252|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446253|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446254|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446255|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446256|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446257|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446258|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446259|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446260|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446261|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446262|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446263|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446264|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446265|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446266|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446267|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446268|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446269|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446270|NCT00880048|O3|Outcome|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446271|NCT00880048|O2|Outcome|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446272|NCT00880048|O1|Outcome|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446273|NCT00880048|E3|Reported Event|GW823296 60 mg|Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
446274|NCT00880048|E2|Reported Event|GW823296 30 mg|Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
446275|NCT00880048|E1|Reported Event|Placebo|Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
446276|NCT00880022|B3|Baseline|Total|Total of all reporting groups
446277|NCT00880022|B2|Baseline|Arm, Trunck and Chest Compression|
446278|NCT00880022|B1|Baseline|Arm Compression Only|
446279|NCT00880022|P2|Participant Flow|Arm, Trunk and Chest Compression|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
446318|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
453771|NCT00858403|P1|Participant Flow|Treatment With Dasatinib|
446280|NCT00880022|P1|Participant Flow|Arm Compression Only|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
446281|NCT00880022|O2|Outcome|Arm, Trunk and Chest Compression|Compression in arm, trunk and chest compression
446282|NCT00880022|O1|Outcome|Arm Compression Only|Compression in Arm only
446283|NCT00880022|O2|Outcome|Arm, Trunck and Chest Compression|
446284|NCT00880022|O1|Outcome|Arm Compression Only|
446285|NCT00880022|E2|Reported Event|Arm, Trunck and Chest Compression|
446286|NCT00880022|E1|Reported Event|Arm Compression Only|
446287|NCT00880009|B1|Baseline|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446288|NCT00880009|P1|Participant Flow|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446289|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446290|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446291|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446292|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446293|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446294|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446295|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446296|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446297|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446298|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446299|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446300|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446301|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446302|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446303|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446304|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446305|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446306|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446307|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446308|NCT00880009|E1|Reported Event|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
446309|NCT00879996|B3|Baseline|Total|Total of all reporting groups
446310|NCT00879996|B2|Baseline|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
446311|NCT00879996|B1|Baseline|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
446312|NCT00879996|P2|Participant Flow|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
446313|NCT00879996|P1|Participant Flow|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
446314|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
446315|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
446316|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
446317|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
446319|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
446320|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
446321|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day divided in 2-4 doses for 6 months
446322|NCT00879996|E2|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
446323|NCT00879996|E1|Reported Event|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
446324|NCT00879970|B4|Baseline|Total|Total of all reporting groups
446325|NCT00879970|B3|Baseline|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446326|NCT00879970|B2|Baseline|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446327|NCT00879970|B1|Baseline|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446328|NCT00879970|P5|Participant Flow|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
446329|NCT00879970|P4|Participant Flow|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
446330|NCT00879970|P3|Participant Flow|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446331|NCT00879970|P2|Participant Flow|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446332|NCT00879970|P1|Participant Flow|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446333|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446334|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446335|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446336|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446337|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446338|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446339|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446340|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446341|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446342|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446343|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446344|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446345|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446346|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446347|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446348|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446349|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446350|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446351|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446352|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446353|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446354|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446355|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446356|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446357|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446358|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446359|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446360|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446361|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446362|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446363|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446364|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446365|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446366|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446367|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446368|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446369|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446370|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446371|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446917|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
446372|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446373|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446374|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446375|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446376|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446377|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446378|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446379|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446380|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446381|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446382|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446383|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446384|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446385|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446386|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446387|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446388|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446389|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446390|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446391|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446392|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446393|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
446394|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
446395|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446396|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446397|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446398|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
446399|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
446400|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446401|NCT00879970|O2|Outcome|Pioglitzaone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446402|NCT00879970|O1|Outcome|Placebo|PLACEBO Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446403|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
446404|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
446405|NCT00879970|O3|Outcome|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446406|NCT00879970|O2|Outcome|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446407|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446408|NCT00879970|E5|Reported Event|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
446409|NCT00879970|E4|Reported Event|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days
446410|NCT00879970|E3|Reported Event|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
446411|NCT00879970|E2|Reported Event|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
446412|NCT00879970|E1|Reported Event|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
446413|NCT00879879|B1|Baseline|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
446414|NCT00879879|P1|Participant Flow|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
446415|NCT00879879|O1|Outcome|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
446416|NCT00879879|E1|Reported Event|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
446417|NCT00879814|B5|Baseline|Total|Total of all reporting groups
446418|NCT00879814|B4|Baseline|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446419|NCT00879814|B3|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446420|NCT00879814|B2|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446421|NCT00879814|B1|Baseline|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446422|NCT00879814|P4|Participant Flow|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446423|NCT00879814|P3|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446424|NCT00879814|P2|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446425|NCT00879814|P1|Participant Flow|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446426|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446427|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446428|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446429|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446430|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446431|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446432|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446433|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446434|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446435|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446436|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446437|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446438|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446439|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446440|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446441|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446442|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446443|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446444|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446445|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446446|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446447|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446448|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446449|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446450|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446451|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446452|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446453|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446454|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446455|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446456|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446457|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446458|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446459|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446460|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446461|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446462|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446463|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446464|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446465|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446466|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446467|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446468|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446469|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446470|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446471|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446472|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446473|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446474|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446475|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446476|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446477|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446478|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446479|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446480|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446481|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446482|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446483|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446484|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446485|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446486|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446487|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446488|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446489|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446490|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446491|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446492|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446493|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446918|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
446494|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446495|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446496|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446497|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446498|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446499|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446500|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446501|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446502|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446503|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446504|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446505|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446506|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446507|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446508|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446509|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446510|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446511|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446512|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446513|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446514|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446515|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446516|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446517|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446518|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446519|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446520|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446521|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446522|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446523|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446524|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446525|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446526|NCT00879814|E4|Reported Event|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
446527|NCT00879814|E3|Reported Event|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
446528|NCT00879814|E2|Reported Event|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
446529|NCT00879814|E1|Reported Event|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
446530|NCT00879775|B3|Baseline|Total|Total of all reporting groups
446531|NCT00879775|B2|Baseline|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446532|NCT00879775|B1|Baseline|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446533|NCT00879775|P2|Participant Flow|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446534|NCT00879775|P1|Participant Flow|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446535|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446536|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446537|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446538|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446539|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446540|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446541|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446542|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446543|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446544|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446545|NCT00879775|E2|Reported Event|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
446546|NCT00879775|E1|Reported Event|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
446547|NCT00879710|B3|Baseline|Total|Total of all reporting groups
446548|NCT00879710|B2|Baseline|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446549|NCT00879710|B1|Baseline|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446550|NCT00879710|P4|Participant Flow|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
446551|NCT00879710|P3|Participant Flow|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
446552|NCT00879710|P2|Participant Flow|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
446553|NCT00879710|P1|Participant Flow|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
446554|NCT00879710|O2|Outcome|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446555|NCT00879710|O1|Outcome|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446556|NCT00879710|E4|Reported Event|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,~4 weeks washout period~Simvastatin 40 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446557|NCT00879710|E3|Reported Event|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,~4 weeks washout period~Simvastatin 40 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446558|NCT00879710|E2|Reported Event|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446559|NCT00879710|E1|Reported Event|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
446560|NCT00879697|B3|Baseline|Total|Total of all reporting groups
446561|NCT00879697|B2|Baseline|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
446562|NCT00879697|B1|Baseline|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
446563|NCT00879697|P2|Participant Flow|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds (s) of each exercise bout.
453772|NCT00858403|O1|Outcome|Treatment With Dasatinib|
446564|NCT00879697|P1|Participant Flow|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
446565|NCT00879697|O2|Outcome|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
446566|NCT00879697|O1|Outcome|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
446567|NCT00879697|E2|Reported Event|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
446568|NCT00879697|E1|Reported Event|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
446569|NCT00879684|B1|Baseline|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2, administered once-weekly in a 4-week cycle.
446570|NCT00879684|P7|Participant Flow|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
446571|NCT00879684|P6|Participant Flow|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446572|NCT00879684|P5|Participant Flow|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446573|NCT00879684|P4|Participant Flow|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446574|NCT00879684|P3|Participant Flow|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446575|NCT00879684|P2|Participant Flow|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446576|NCT00879684|P1|Participant Flow|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446577|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
446578|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446579|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446580|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446581|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446582|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446583|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446584|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
446585|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
446586|NCT00879684|O1|Outcome|CVX-060 (Stage 1)|All participants who received 0.3, 1, 3, 6, 12, 15 mg/kg intravenous infusion once-weekly in Stage 1. Participants who discontinued treatment at any time were followed for 6 weeks to assess toxicity, pharmacokinetics (elimination half-life), and immunogenicity.
446587|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
446588|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446589|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446590|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446591|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446592|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446593|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
446594|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446595|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446596|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446597|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446598|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446599|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
446600|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446601|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446602|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446603|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446604|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446605|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
446606|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446607|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446608|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446609|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446610|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446611|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
446612|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446613|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446614|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446615|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446616|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446617|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
446618|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446619|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446620|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446621|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446622|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446623|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
446624|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446625|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446626|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446627|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446628|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446629|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446630|NCT00879684|E7|Reported Event|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
446631|NCT00879684|E6|Reported Event|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446632|NCT00879684|E5|Reported Event|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446633|NCT00879684|E4|Reported Event|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446634|NCT00879684|E3|Reported Event|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446635|NCT00879684|E2|Reported Event|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446636|NCT00879684|E1|Reported Event|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
446637|NCT00879645|B5|Baseline|Total|Total of all reporting groups
446638|NCT00879645|B4|Baseline|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
446639|NCT00879645|B3|Baseline|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
446640|NCT00879645|B2|Baseline|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
446641|NCT00879645|B1|Baseline|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
446642|NCT00879645|P4|Participant Flow|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
446643|NCT00879645|P3|Participant Flow|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
446644|NCT00879645|P2|Participant Flow|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
446645|NCT00879645|P1|Participant Flow|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
446646|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
446647|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
446648|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
446649|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
446650|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
446651|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
446652|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
446653|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
446654|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
446655|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
446656|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
446657|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
446658|NCT00879645|E4|Reported Event|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
446659|NCT00879645|E3|Reported Event|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
446660|NCT00879645|E2|Reported Event|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
446661|NCT00879645|E1|Reported Event|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
446662|NCT00879619|B1|Baseline|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446663|NCT00879619|P1|Participant Flow|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446664|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446665|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446666|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446667|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446668|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446669|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446670|NCT00879619|E1|Reported Event|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
446671|NCT00879411|B1|Baseline|Telmisartan, Hydrochlorothiazide|
446672|NCT00879411|P1|Participant Flow|Telmisartan, Hydrochlorothiazide|
446673|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
446674|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
446675|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
446676|NCT00879411|E1|Reported Event|Telmisartan, Hydrochlorothiazide|
446677|NCT00879398|B1|Baseline|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446678|NCT00879398|P1|Participant Flow|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446679|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446680|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446681|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446682|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446683|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446684|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446685|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446686|NCT00879398|E1|Reported Event|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
446687|NCT00879359|B1|Baseline|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
446688|NCT00879359|P1|Participant Flow|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
446765|NCT00879190|E2|Reported Event|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
446689|NCT00879359|O1|Outcome|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
446690|NCT00879359|O1|Outcome|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
446691|NCT00879359|O1|Outcome|Maintenance With Bevacizumab|carboplatin, paclitaxel, and bevacizumab: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
446692|NCT00879359|E1|Reported Event|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
446693|NCT00879333|B3|Baseline|Total|Total of all reporting groups
446694|NCT00879333|B2|Baseline|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446695|NCT00879333|B1|Baseline|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446696|NCT00879333|P2|Participant Flow|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446697|NCT00879333|P1|Participant Flow|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446698|NCT00879333|O2|Outcome|Everolimus 5mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 5 mg tablet of everolimus once daily. One of the 11 patients on the 5 mg arm, only had a pre-dose evaluable sample.
446699|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446700|NCT00879333|O2|Outcome|Everolimus 5 mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 1 5 mg tablet of everolimus once daily. Two of the 18 patients on the 5 mg arm, only had pre-dose evaluable samples.
446701|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446702|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446703|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446704|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446705|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446706|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446707|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446708|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446911|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
446709|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446710|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446711|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
446712|NCT00879333|E2|Reported Event|Placebo|Placebo
446713|NCT00879333|E1|Reported Event|Everolimus 10mg / Daily|Everolimus 10mg / daily
446714|NCT00879255|B3|Baseline|Total|Total of all reporting groups
446715|NCT00879255|B2|Baseline|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
446716|NCT00879255|B1|Baseline|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
446717|NCT00879255|P2|Participant Flow|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
446718|NCT00879255|P1|Participant Flow|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
446719|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
446720|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
446721|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
446722|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
446723|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
446724|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
446725|NCT00879255|E2|Reported Event|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
446726|NCT00879255|E1|Reported Event|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
446727|NCT00879229|B3|Baseline|Total|Total of all reporting groups
446728|NCT00879229|B2|Baseline|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446729|NCT00879229|B1|Baseline|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446730|NCT00879229|P2|Participant Flow|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446731|NCT00879229|P1|Participant Flow|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446732|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446733|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446734|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446735|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446736|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446737|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446738|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446739|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446740|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446741|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446742|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446743|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446744|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446745|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446746|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446747|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446748|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446749|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446750|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446751|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446752|NCT00879229|E2|Reported Event|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
446753|NCT00879229|E1|Reported Event|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
446754|NCT00879190|B3|Baseline|Total|Total of all reporting groups
446755|NCT00879190|B2|Baseline|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
446756|NCT00879190|B1|Baseline|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
446757|NCT00879190|P2|Participant Flow|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
446758|NCT00879190|P1|Participant Flow|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
446759|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
446760|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
446761|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
446762|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
446763|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
446764|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
446766|NCT00879190|E1|Reported Event|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
446767|NCT00879034|B1|Baseline|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446768|NCT00879034|P1|Participant Flow|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446769|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446770|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446771|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446772|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446773|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446774|NCT00879034|O1|Outcome|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446775|NCT00879034|E1|Reported Event|Zoledronic Acid, Pravastatin, and Lonafarnib|Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.
446776|NCT00878995|B3|Baseline|Total|Total of all reporting groups
446912|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
446913|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
446777|NCT00878995|B2|Baseline|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446778|NCT00878995|B1|Baseline|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446779|NCT00878995|P2|Participant Flow|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446780|NCT00878995|P1|Participant Flow|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446781|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446782|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446783|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446784|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446785|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446786|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446787|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446788|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446789|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446790|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446791|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446792|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446793|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446794|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446795|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446914|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
446915|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
446916|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
446796|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446797|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446798|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446799|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446800|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446801|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446802|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446803|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446804|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446805|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446806|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446807|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446808|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446809|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446810|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446811|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446812|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446813|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446814|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446815|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446816|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446817|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446818|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446819|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446820|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446821|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446822|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446823|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446824|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446825|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446826|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446827|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446828|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446829|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446830|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446831|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446832|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446833|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446834|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446835|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446836|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446837|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446838|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446839|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446840|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446841|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446842|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446843|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446844|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446845|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446846|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446847|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446848|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446849|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446850|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446851|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446852|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446853|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446854|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446855|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446856|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446857|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446858|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446859|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446860|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446861|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446862|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446863|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446864|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446865|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446866|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446867|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446868|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446869|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446870|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446871|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446872|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446873|NCT00878995|O2|Outcome|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446874|NCT00878995|O1|Outcome|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446875|NCT00878995|E2|Reported Event|Arm II: Standard of Care Therapy + Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.~Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate"
446876|NCT00878995|E1|Reported Event|Arm I: Standard of Care Therapy + Placebo Testosterone|"Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.~Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone"
446877|NCT00878969|B4|Baseline|Total|Total of all reporting groups
446878|NCT00878969|B3|Baseline|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
446879|NCT00878969|B2|Baseline|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 6 mg of ramipril taken orally on a daily basis for 18 months
446880|NCT00878969|B1|Baseline|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
446881|NCT00878969|P3|Participant Flow|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
446882|NCT00878969|P2|Participant Flow|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
446883|NCT00878969|P1|Participant Flow|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
446884|NCT00878969|O3|Outcome|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
446885|NCT00878969|O2|Outcome|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
446886|NCT00878969|O1|Outcome|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
446887|NCT00878969|E3|Reported Event|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
446888|NCT00878969|E2|Reported Event|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
446889|NCT00878969|E1|Reported Event|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
446890|NCT00878878|B3|Baseline|Total|Total of all reporting groups
446891|NCT00878878|B2|Baseline|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
446892|NCT00878878|B1|Baseline|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
446893|NCT00878878|P2|Participant Flow|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
446894|NCT00878878|P1|Participant Flow|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
446895|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
446896|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
446897|NCT00878878|O2|Outcome|Elevated Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with elevated pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
446898|NCT00878878|O1|Outcome|Normal Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with normal pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
446899|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
446900|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
446901|NCT00878878|E2|Reported Event|Placebo Control (5% Dextrose) First Followed by the Optison|Placebo Control (5% Dextrose) given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP. There was a 15 minute interval between the injections.
446902|NCT00878878|E1|Reported Event|Optison Product First Followed by Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
446903|NCT00878826|B4|Baseline|Total|Total of all reporting groups
446904|NCT00878826|B3|Baseline|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
446905|NCT00878826|B2|Baseline|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
446906|NCT00878826|B1|Baseline|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
446907|NCT00878826|P3|Participant Flow|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
446908|NCT00878826|P2|Participant Flow|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
446909|NCT00878826|P1|Participant Flow|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
446910|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
446919|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
446920|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
446921|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
446922|NCT00878826|E3|Reported Event|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
446923|NCT00878826|E2|Reported Event|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
446924|NCT00878826|E1|Reported Event|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
446925|NCT00878800|B6|Baseline|Total|Total of all reporting groups
446926|NCT00878800|B5|Baseline|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446927|NCT00878800|B4|Baseline|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446928|NCT00878800|B3|Baseline|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
446929|NCT00878800|B2|Baseline|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
446930|NCT00878800|B1|Baseline|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
446931|NCT00878800|P5|Participant Flow|MTD Expansion: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446932|NCT00878800|P4|Participant Flow|Cohort 4: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446933|NCT00878800|P3|Participant Flow|Cohort 3: BelDox IV (800/75)|PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
446934|NCT00878800|P2|Participant Flow|Cohort 2: BelDox IV (600/75)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
446935|NCT00878800|P1|Participant Flow|Cohort 1: BelDox IV (600/50)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
446936|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
446937|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
446938|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
446939|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
446940|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
446941|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
446942|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446943|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446944|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446945|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446946|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446947|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446948|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446949|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446950|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446951|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446952|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446953|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446954|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446955|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
446956|NCT00878800|E5|Reported Event|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446957|NCT00878800|E4|Reported Event|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
446958|NCT00878800|E3|Reported Event|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
446959|NCT00878800|E2|Reported Event|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
446960|NCT00878800|E1|Reported Event|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
446961|NCT00878722|B9|Baseline|Total|Total of all reporting groups
446962|NCT00878722|B8|Baseline|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446963|NCT00878722|B7|Baseline|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446964|NCT00878722|B6|Baseline|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446965|NCT00878722|B5|Baseline|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
446966|NCT00878722|B4|Baseline|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447188|NCT00878501|P1|Participant Flow|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
446967|NCT00878722|B3|Baseline|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
446968|NCT00878722|B2|Baseline|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
446969|NCT00878722|B1|Baseline|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
446970|NCT00878722|P8|Participant Flow|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446971|NCT00878722|P7|Participant Flow|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446972|NCT00878722|P6|Participant Flow|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446973|NCT00878722|P5|Participant Flow|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
446974|NCT00878722|P4|Participant Flow|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
446975|NCT00878722|P3|Participant Flow|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
446976|NCT00878722|P2|Participant Flow|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
446977|NCT00878722|P1|Participant Flow|Arm A, Step 1|PXD101 (belinostat) 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
446978|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
446979|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
446980|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
446981|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
446982|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
446983|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
446984|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
446985|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
446986|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
446987|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446988|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446989|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446990|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
446991|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
446992|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
446993|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
446994|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
446995|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446996|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446997|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
446998|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
446999|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447000|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447001|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447002|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447003|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447004|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447005|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447006|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
447007|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447008|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447189|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
447009|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447010|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447011|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447012|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447013|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447014|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
447015|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447016|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447017|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447018|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447019|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447020|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447021|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447022|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
447023|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447024|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447025|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447026|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447027|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447028|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447029|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447030|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
447031|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447032|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447033|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447034|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447035|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447036|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447037|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447038|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
447039|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447040|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447041|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447042|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447043|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447044|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447190|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
447191|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
447045|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447046|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
447047|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447048|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447049|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447050|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447051|NCT00878722|E8|Reported Event|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447052|NCT00878722|E7|Reported Event|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447053|NCT00878722|E6|Reported Event|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
447054|NCT00878722|E5|Reported Event|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
447055|NCT00878722|E4|Reported Event|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
447056|NCT00878722|E3|Reported Event|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
447057|NCT00878722|E2|Reported Event|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
447058|NCT00878722|E1|Reported Event|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
447059|NCT00878709|B3|Baseline|Total|Total of all reporting groups
447060|NCT00878709|B2|Baseline|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447061|NCT00878709|B1|Baseline|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447062|NCT00878709|P2|Participant Flow|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year.Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447063|NCT00878709|P1|Participant Flow|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447064|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447065|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447066|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447067|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447068|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447069|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447070|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447071|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447072|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447073|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447074|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447075|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447076|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447077|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447078|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447079|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447080|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447081|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447082|NCT00878709|O2|Outcome|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447083|NCT00878709|O1|Outcome|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447084|NCT00878709|E2|Reported Event|Placebo|Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447085|NCT00878709|E1|Reported Event|Neratinib|Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
447086|NCT00878644|B3|Baseline|Total|Total of all reporting groups
447087|NCT00878644|B2|Baseline|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
447088|NCT00878644|B1|Baseline|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
447089|NCT00878644|P2|Participant Flow|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
447090|NCT00878644|P1|Participant Flow|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
447091|NCT00878644|O2|Outcome|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
447092|NCT00878644|O1|Outcome|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
447093|NCT00878644|O2|Outcome|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
447192|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
447193|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
447094|NCT00878644|O1|Outcome|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
447095|NCT00878644|O2|Outcome|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
447096|NCT00878644|O1|Outcome|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
447097|NCT00878644|O2|Outcome|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
447098|NCT00878644|O1|Outcome|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
447099|NCT00878644|E2|Reported Event|Therapeutic Normothermia|"Participants will receive therapeutic normothermia after experiencing cardiac arrest.~Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest."
447100|NCT00878644|E1|Reported Event|Therapeutic Hypothermia|"Participants will receive therapeutic hypothermia after experiencing cardiac arrest.~Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest."
447101|NCT00878605|B5|Baseline|Total|Total of all reporting groups
447102|NCT00878605|B4|Baseline|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447103|NCT00878605|B3|Baseline|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447104|NCT00878605|B2|Baseline|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447105|NCT00878605|B1|Baseline|Placebo|"Placebo control~Placebo: Placebo control"
447106|NCT00878605|P4|Participant Flow|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 15mg + 20 mg zinc orally per day for 12 weeks."
447107|NCT00878605|P3|Participant Flow|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 9mg + 20 mg zinc orally per day for 12 weeks."
447108|NCT00878605|P2|Participant Flow|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 3mg + 20 mg zinc orally per day for 12 weeks."
447109|NCT00878605|P1|Participant Flow|Arm 1|"Placebo control~Placebo: Placebo control~Participants received placebo tablet orally daily for 12 weeks."
447110|NCT00878605|O4|Outcome|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447111|NCT00878605|O3|Outcome|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447112|NCT00878605|O2|Outcome|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447113|NCT00878605|O1|Outcome|Placebo|"Placebo control~Placebo: Placebo control"
447114|NCT00878605|E4|Reported Event|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447115|NCT00878605|E3|Reported Event|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447116|NCT00878605|E2|Reported Event|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
447117|NCT00878605|E1|Reported Event|Arm 1|"Placebo control~Placebo: Placebo control"
447118|NCT00878553|B5|Baseline|Total|Total of all reporting groups
447119|NCT00878553|B4|Baseline|Sequence 4|15mg SKP-1041, 10mg SKP-1041, 20mg SKP-1041, Placebo
447120|NCT00878553|B3|Baseline|Sequence 3|20mg SKP-1041, Placebo, 15mg SKP-1041, 10mg SKP-1041
447121|NCT00878553|B2|Baseline|Sequence 2|Placebo, 10mg SKP-1041, 20mg SKP-1041, 15mg SKP-1041
447122|NCT00878553|B1|Baseline|Sequence 1|10mg SKP-1041, 15mg SKP-1041, Placebo, 20mg SKP-1041
447123|NCT00878553|P5|Participant Flow|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
453773|NCT00858403|O1|Outcome|Treatment With Dasatinib|
447124|NCT00878553|P4|Participant Flow|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447125|NCT00878553|P3|Participant Flow|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447126|NCT00878553|P2|Participant Flow|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment. Two placebo tablets were administered orally at bedtime for two consecutive nights during the Sleep Study, after which patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned for the next treatment in their randomized sequence.
447127|NCT00878553|P1|Participant Flow|Baseline: All Randomized Patients|"The second screening visit consisted of 2 consecutive sleep laboratory nights of placebo pretreatment and full PSG recordings. The 67 patients who met entry criteria were then randomized to four treatment sequences with their screening night mean PSG parameters defined as their baseline.~This trial was comprised of 2 study periods: Sleep and Pharmacokinetic (PK). Each of 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence for the Sleep Study. For each of these treatment arms, two double-dummy tablets were administered at bedtime for two consecutive nights. An additional (third) dosing night allowed for pharmacokinetic characterization of the investigational zaleplon formulation. In this PK Substudy, patient's plasma concentrations were measured after a single dose in parallel group design."
447128|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447129|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447130|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447131|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447132|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447133|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447134|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447135|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447136|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447137|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447138|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447194|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
447195|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
447139|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447140|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447141|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447142|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447143|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447144|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447145|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
447146|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447147|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447148|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10 mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447149|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447150|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447151|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447152|NCT00878553|O2|Outcome|10 mg SKP=1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447153|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447196|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
447154|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447155|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447156|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447157|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447158|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447159|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447160|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447161|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447162|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447163|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447164|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447165|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447166|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447197|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
447198|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
447199|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
447200|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
447201|NCT00878501|E3|Reported Event|Placebo Control|Placebo bid for 4 weeks
447167|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447168|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447169|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447170|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447171|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447172|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447173|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447174|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447175|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447176|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447177|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
447178|NCT00878553|E4|Reported Event|20mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
447179|NCT00878553|E3|Reported Event|15mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
447180|NCT00878553|E2|Reported Event|10 mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
447181|NCT00878553|E1|Reported Event|Placebo|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
447182|NCT00878501|B4|Baseline|Total|Total of all reporting groups
447183|NCT00878501|B3|Baseline|Placebo Control|Placebo bid for 4 weeks
447184|NCT00878501|B2|Baseline|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
447185|NCT00878501|B1|Baseline|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
447186|NCT00878501|P3|Participant Flow|Placebo Control|Placebo bid for 4 weeks
447187|NCT00878501|P2|Participant Flow|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
447202|NCT00878501|E2|Reported Event|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
447203|NCT00878501|E1|Reported Event|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
447204|NCT00878436|B3|Baseline|Total|Total of all reporting groups
447205|NCT00878436|B2|Baseline|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447206|NCT00878436|B1|Baseline|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447207|NCT00878436|P2|Participant Flow|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447208|NCT00878436|P1|Participant Flow|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447209|NCT00878436|O2|Outcome|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447210|NCT00878436|O1|Outcome|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447211|NCT00878436|O2|Outcome|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447212|NCT00878436|O1|Outcome|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447213|NCT00878436|O2|Outcome|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447214|NCT00878436|O1|Outcome|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447215|NCT00878436|O2|Outcome|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447216|NCT00878436|O1|Outcome|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447217|NCT00878436|E2|Reported Event|LBH 20mg|Participants assigned to this arm received 20mg of LBH589 (LBH) three times a week (for a total weekly dose of 60mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447218|NCT00878436|E1|Reported Event|LBH 40mg|Participants assigned to this arm received 40mg of LBH589 (LBH) three times a week (for a total weekly dose of 120mg). Additionally, they received 50mg of bicalutamide (Bic) daily.
447219|NCT00878228|B3|Baseline|Total|Total of all reporting groups
447220|NCT00878228|B2|Baseline|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
447221|NCT00878228|B1|Baseline|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
447222|NCT00878228|P2|Participant Flow|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
447223|NCT00878228|P1|Participant Flow|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
447224|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
447225|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
447226|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
447227|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
447228|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
447229|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
447230|NCT00878228|E2|Reported Event|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
447231|NCT00878228|E1|Reported Event|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
447232|NCT00878215|B5|Baseline|Total|Total of all reporting groups
447233|NCT00878215|B4|Baseline|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
447234|NCT00878215|B3|Baseline|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
447235|NCT00878215|B2|Baseline|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
447236|NCT00878215|B1|Baseline|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
447237|NCT00878215|P4|Participant Flow|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
447238|NCT00878215|P3|Participant Flow|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
447239|NCT00878215|P2|Participant Flow|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
447240|NCT00878215|P1|Participant Flow|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
447241|NCT00878215|O1|Outcome|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
447242|NCT00878215|O1|Outcome|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
447243|NCT00878215|O1|Outcome|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
447244|NCT00878215|O1|Outcome|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
447245|NCT00878215|E4|Reported Event|Phase 4: Ablative Therapy (Not Liver Resection Candidates)|-This phase is for patients who otherwise do not qualify to have a portion of their liver to be surgically removed. The surgeon will use image-guidance to create the mapping with 3-D pictures of the liver. The tumors will be ablated using image-guided therapy.
447246|NCT00878215|E3|Reported Event|Phase 3: Ablative Therapy|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. The liver tumors will be ablated using image-guided surgery. Standard surgical procedures will then be used to remove the portion of the liver that has the ablated tumors. The accuracy of the ablation will be confirmed via pathology sectioning.
447247|NCT00878215|E2|Reported Event|Phase 2: Ceramic Bead|-The surgeon will use image-guided surgery to create the mapping with 3-D pictures of the liver. During the surgery, a ceramic bead will be placed in a pre-operatively determined target location within the tumor using image-guided surgery. Standard surgical procedures will then be used to remove the tumors. Magnetic resonance (MR) images of the resected liver will confirm targeting accuracy.
447248|NCT00878215|E1|Reported Event|Phase 1:Localize Anatomical Points on Liver Surface|-The surgeon will use image-guided surgery equipment to create the mapping with 3-D pictures of the participants liver. Laser range scanning will also be used to take 3-D pictures of the liver surface. The participant will then have planned standard surgery.
447249|NCT00877929|B3|Baseline|Total|Total of all reporting groups
447250|NCT00877929|B2|Baseline|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447251|NCT00877929|B1|Baseline|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447252|NCT00877929|P2|Participant Flow|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447253|NCT00877929|P1|Participant Flow|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447254|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447255|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447256|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447257|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447258|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447259|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447260|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447261|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447262|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447263|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447264|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447265|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447266|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447267|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447268|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447269|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447270|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447271|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447272|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447273|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447274|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447275|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447276|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447277|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447278|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447279|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447280|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447281|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447282|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447283|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447284|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447285|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447286|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447287|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447288|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447289|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447290|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447291|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447292|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447293|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447294|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447295|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447296|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447297|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447298|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447299|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447300|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447301|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447302|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447303|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447304|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447305|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447306|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447307|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447308|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447309|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447310|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447311|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447312|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447313|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447314|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447315|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447316|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447317|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447318|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447319|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447320|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447321|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447322|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447323|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447324|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447325|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447326|NCT00877929|O2|Outcome|Amlodipine 5 mg|
447327|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
447328|NCT00877929|O2|Outcome|Amlodipine 5 mg|
447329|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
447330|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447331|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447332|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447333|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447334|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447335|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447336|NCT00877929|E2|Reported Event|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
447449|NCT00877448|B8|Baseline|Total|Total of all reporting groups
447337|NCT00877929|E1|Reported Event|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
447338|NCT00877890|B3|Baseline|Total|Total of all reporting groups
447339|NCT00877890|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447340|NCT00877890|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447341|NCT00877890|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447342|NCT00877890|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447343|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
447344|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
447345|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
447346|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
447347|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
447348|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
447349|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
447350|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
447351|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447352|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447353|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447354|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447355|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447356|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447357|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447358|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447359|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447360|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447361|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447362|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447363|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447364|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447365|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447366|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447367|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447368|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447369|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447370|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447371|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447372|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447373|NCT00877890|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
447374|NCT00877890|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
447375|NCT00877877|B1|Baseline|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447376|NCT00877877|P1|Participant Flow|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447450|NCT00877448|B7|Baseline|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
447377|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447378|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447379|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447380|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447381|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447382|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447383|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447384|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447385|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447386|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447387|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447388|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447389|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447390|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447391|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447392|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447393|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447394|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
447395|NCT00877877|E6|Reported Event|Cervarix Group From Month 108 to Month 120|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
447396|NCT00877877|E5|Reported Event|Cervarix Group From Month 96 to Month 108|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108.
447397|NCT00877877|E4|Reported Event|Cervarix Group From Month 84 to Month 96|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96.
447398|NCT00877877|E3|Reported Event|Cervarix Group From Month 72 to Month 84|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84.
447399|NCT00877877|E2|Reported Event|Cervarix Group From Month 60 Until Month 72|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72.
447451|NCT00877448|B6|Baseline|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
447452|NCT00877448|B5|Baseline|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
447400|NCT00877877|E1|Reported Event|Cervarix Group From Month 48 Until Month 60|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60.
447401|NCT00877799|B6|Baseline|Total|Total of all reporting groups
447402|NCT00877799|B5|Baseline|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours post-surgery (Day 0)
447403|NCT00877799|B4|Baseline|Cohort 2: Placebo|Matched placebo administered within 3 hours post-surgery (Day 0)
447404|NCT00877799|B3|Baseline|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
447405|NCT00877799|B2|Baseline|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
447406|NCT00877799|B1|Baseline|Cohort 1: Placebo|Matched placebo administered 24 hours post-surgery (Day 1)
447407|NCT00877799|P5|Participant Flow|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours after surgery (Day 0)
447408|NCT00877799|P4|Participant Flow|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
447409|NCT00877799|P3|Participant Flow|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
447410|NCT00877799|P2|Participant Flow|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
447411|NCT00877799|P1|Participant Flow|Cohort 1: Placebo|Matched Placebo administered 24 hours post-surgery (Day 1)
447412|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
447413|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
447414|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
447415|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
447416|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
447417|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
447418|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
447419|NCT00877799|O1|Outcome|Cohort 2: Placebo|Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
447420|NCT00877799|E5|Reported Event|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0)
447421|NCT00877799|E4|Reported Event|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
447422|NCT00877799|E3|Reported Event|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1)
447423|NCT00877799|E2|Reported Event|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1)
447424|NCT00877799|E1|Reported Event|Cohort 1: Placebo|Matched placebo administered 24 hours after surgery (Day 1)
447425|NCT00877773|B1|Baseline|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
447426|NCT00877773|P1|Participant Flow|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
447427|NCT00877773|O1|Outcome|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
447428|NCT00877773|E1|Reported Event|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
447429|NCT00877604|B3|Baseline|Total|Total of all reporting groups
447430|NCT00877604|B2|Baseline|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule"
447431|NCT00877604|B1|Baseline|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
447432|NCT00877604|P2|Participant Flow|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
447433|NCT00877604|P1|Participant Flow|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
447434|NCT00877604|O2|Outcome|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
447435|NCT00877604|O1|Outcome|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
447436|NCT00877604|E2|Reported Event|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
447437|NCT00877604|E1|Reported Event|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
447438|NCT00877487|B1|Baseline|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
447439|NCT00877487|P2|Participant Flow|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
447440|NCT00877487|P1|Participant Flow|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
447441|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
447442|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
447443|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
447444|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
447445|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
447446|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
447447|NCT00877487|E2|Reported Event|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
447448|NCT00877487|E1|Reported Event|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
447453|NCT00877448|B4|Baseline|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
447454|NCT00877448|B3|Baseline|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
447455|NCT00877448|B2|Baseline|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
447456|NCT00877448|B1|Baseline|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
447457|NCT00877448|P7|Participant Flow|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
447458|NCT00877448|P6|Participant Flow|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
447459|NCT00877448|P5|Participant Flow|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
447460|NCT00877448|P4|Participant Flow|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
447461|NCT00877448|P3|Participant Flow|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
447462|NCT00877448|P2|Participant Flow|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
447463|NCT00877448|P1|Participant Flow|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
447464|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
447465|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
447466|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
447467|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
447468|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
447469|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
447470|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
447471|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
447472|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
447473|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
447474|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
447475|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
447476|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
447477|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
447478|NCT00877448|E7|Reported Event|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
447479|NCT00877448|E6|Reported Event|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
447480|NCT00877448|E5|Reported Event|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
447481|NCT00877448|E4|Reported Event|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
447482|NCT00877448|E3|Reported Event|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
447483|NCT00877448|E2|Reported Event|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
447484|NCT00877448|E1|Reported Event|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
447485|NCT00877383|B3|Baseline|Total|Total of all reporting groups
447486|NCT00877383|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447487|NCT00877383|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447488|NCT00877383|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447489|NCT00877383|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447490|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447491|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447492|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447493|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447494|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447495|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447496|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447497|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447498|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447499|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447500|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447501|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
453774|NCT00858403|O1|Outcome|Treatment With Dasatinib|
447502|NCT00877383|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447503|NCT00877383|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
447504|NCT00877370|B1|Baseline|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
447505|NCT00877370|P1|Participant Flow|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
447506|NCT00877370|O1|Outcome|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
447507|NCT00877370|E1|Reported Event|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
447508|NCT00877071|B1|Baseline|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
447509|NCT00877071|P1|Participant Flow|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
447510|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
447511|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
447572|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447573|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447512|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
447513|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
447514|NCT00877071|E1|Reported Event|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
447515|NCT00877058|B4|Baseline|Total|Total of all reporting groups
447516|NCT00877058|B3|Baseline|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
447517|NCT00877058|B2|Baseline|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
447518|NCT00877058|B1|Baseline|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
447519|NCT00877058|P3|Participant Flow|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
447520|NCT00877058|P2|Participant Flow|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings. http://www.vardalinstitutet.net/livslots.pdf.
447521|NCT00877058|P1|Participant Flow|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
447522|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
447574|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447575|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447523|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
447524|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
447525|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
447526|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
447527|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
447528|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
447529|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
447530|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
447531|NCT00877058|E3|Reported Event|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
447576|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447577|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447578|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447579|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447580|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447532|NCT00877058|E2|Reported Event|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
447533|NCT00877058|E1|Reported Event|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
447534|NCT00877032|B8|Baseline|Total|Total of all reporting groups
447535|NCT00877032|B7|Baseline|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447536|NCT00877032|B6|Baseline|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447537|NCT00877032|B5|Baseline|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447538|NCT00877032|B4|Baseline|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447539|NCT00877032|B3|Baseline|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447540|NCT00877032|B2|Baseline|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447541|NCT00877032|B1|Baseline|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447542|NCT00877032|P7|Participant Flow|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447543|NCT00877032|P6|Participant Flow|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447544|NCT00877032|P5|Participant Flow|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447545|NCT00877032|P4|Participant Flow|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447546|NCT00877032|P3|Participant Flow|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447547|NCT00877032|P2|Participant Flow|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447548|NCT00877032|P1|Participant Flow|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447549|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447550|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447551|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447552|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447553|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447554|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447555|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447556|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447557|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447558|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447559|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447560|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447561|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447562|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447563|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447564|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447565|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447566|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447567|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447568|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447569|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447570|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447571|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447942|NCT00876447|B3|Baseline|Total|Total of all reporting groups
447581|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447582|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447583|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447584|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447585|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447586|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447587|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447588|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447589|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447590|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447591|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447592|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447593|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447594|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447595|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447596|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447597|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447598|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447599|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447600|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447601|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447602|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447603|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447604|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447605|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447606|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447607|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447608|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447609|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447610|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447611|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447612|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447613|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447614|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447615|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447616|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447617|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447618|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447619|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447620|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447621|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447622|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447623|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447624|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447625|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447626|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447627|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447628|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447629|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447630|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447631|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447632|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447633|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447634|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447635|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447636|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447637|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447638|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447639|NCT00877032|E7|Reported Event|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
447640|NCT00877032|E6|Reported Event|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
447641|NCT00877032|E5|Reported Event|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
447642|NCT00877032|E4|Reported Event|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
447643|NCT00877032|E3|Reported Event|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
447644|NCT00877032|E2|Reported Event|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
447645|NCT00877032|E1|Reported Event|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
447646|NCT00877006|B3|Baseline|Total|Total of all reporting groups
447647|NCT00877006|B2|Baseline|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447648|NCT00877006|B1|Baseline|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447649|NCT00877006|P2|Participant Flow|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447650|NCT00877006|P1|Participant Flow|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447651|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447652|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447653|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447654|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447655|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447656|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447943|NCT00876447|B2|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447657|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447658|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447659|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447660|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447661|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447662|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447663|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447664|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447665|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447666|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447667|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447668|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447669|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"R-CHOP, consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, doxorubicin at 50 mg/m2 by iv over 3-5 minutes on day 1, cyclophosphamide iv at 750 mg/m2 on day 1.~R-CVP consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, only 1 of the following doses of cyclophosphamide throughout the study: cyclophosphamide at 750 mg/m2 iv on day 1 or cyclophosphamide at 1000 mg/m2 iv on day 1."
447670|NCT00877006|O1|Outcome|Bendamustine/Rituximab|bendamustine at 90 mg/m2 iv on days 1 and 2 and rituximab at 375 mg/m2 iv infusion on day 1
447671|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447672|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447673|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447674|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447675|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447676|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447677|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447678|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447679|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447680|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447681|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447682|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447683|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447684|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447685|NCT00877006|E2|Reported Event|R-CHOP/CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
447686|NCT00877006|E1|Reported Event|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
447687|NCT00876928|B3|Baseline|Total|Total of all reporting groups
447688|NCT00876928|B2|Baseline|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
447689|NCT00876928|B1|Baseline|Placebo|Subjects with low vitamin D levels and pre-diabetes
447690|NCT00876928|P2|Participant Flow|Vitamin D|"Subjects with low vitamin D levels and pre-diabetes~Liquid vitamin D3 dissolved in medium chain triglyceride once per week"
447691|NCT00876928|P1|Participant Flow|Placebo|"Subjects with low vitamin D levels and pre-diabetes~Medium chain triglyceride given once per week"
447692|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
447693|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
447694|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
447695|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
447696|NCT00876928|E2|Reported Event|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
447697|NCT00876928|E1|Reported Event|Placebo|Subjects with low vitamin D levels and pre-diabetes
447698|NCT00876915|B4|Baseline|Total|Total of all reporting groups
447699|NCT00876915|B3|Baseline|Low Risk|Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
447700|NCT00876915|B2|Baseline|High Risk Randomized to No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
447701|NCT00876915|B1|Baseline|High Risk Randomized to Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
447944|NCT00876447|B1|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447702|NCT00876915|P3|Participant Flow|Low or Medium Risk Group|Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.
447703|NCT00876915|P2|Participant Flow|High Risk No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
447704|NCT00876915|P1|Participant Flow|High Risk Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
447705|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
447706|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
447707|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
447708|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
447709|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
447710|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
447711|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
447712|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
447713|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
447714|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
447715|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
447716|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
447717|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
447718|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
447719|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
447720|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
447721|NCT00876915|E2|Reported Event|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
447722|NCT00876915|E1|Reported Event|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
447723|NCT00876733|B5|Baseline|Total|Total of all reporting groups
447724|NCT00876733|B4|Baseline|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447725|NCT00876733|B3|Baseline|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447726|NCT00876733|B2|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447727|NCT00876733|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447728|NCT00876733|P4|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447729|NCT00876733|P3|Participant Flow|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447730|NCT00876733|P2|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447731|NCT00876733|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447732|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447733|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447734|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447735|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447736|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447737|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447738|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447739|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447740|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447741|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447742|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447743|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447744|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447745|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447746|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447747|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447748|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447749|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447750|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447751|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447752|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447753|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447754|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447755|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447756|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447757|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447758|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447759|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447760|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447761|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447762|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447763|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447764|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447765|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447766|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447767|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447768|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447769|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447770|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447771|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447772|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447773|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447774|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447775|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447776|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447777|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447778|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447779|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447780|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447781|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447782|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447783|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447784|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447785|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447786|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447787|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447788|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447789|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447790|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447791|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447792|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447793|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447794|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447795|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447796|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447797|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447798|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447799|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447800|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447801|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447802|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447803|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447804|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447805|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447806|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447807|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447808|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447809|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447810|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447811|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447812|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447813|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447814|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447815|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447816|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447817|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447818|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447819|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447820|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447821|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447822|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447823|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447824|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447825|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447826|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447827|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447828|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447829|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447830|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447831|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447832|NCT00876733|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
447833|NCT00876733|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
447834|NCT00876733|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
447835|NCT00876733|E1|Reported Event|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
447836|NCT00876694|B3|Baseline|Total|Total of all reporting groups
447837|NCT00876694|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447838|NCT00876694|B1|Baseline|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447839|NCT00876694|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447840|NCT00876694|P1|Participant Flow|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447841|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447842|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447843|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447844|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447845|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447846|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447847|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447848|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447849|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447850|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447945|NCT00876447|P2|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447851|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447852|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447853|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447854|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447855|NCT00876694|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447856|NCT00876694|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
447857|NCT00876460|B9|Baseline|Total|Total of all reporting groups
447858|NCT00876460|B8|Baseline|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447859|NCT00876460|B7|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447860|NCT00876460|B6|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447861|NCT00876460|B5|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447862|NCT00876460|B4|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447863|NCT00876460|B3|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447864|NCT00876460|B2|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447865|NCT00876460|B1|Baseline|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447866|NCT00876460|P8|Participant Flow|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447867|NCT00876460|P7|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447868|NCT00876460|P6|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447869|NCT00876460|P5|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447870|NCT00876460|P4|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447871|NCT00876460|P3|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447946|NCT00876447|P1|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447872|NCT00876460|P2|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447873|NCT00876460|P1|Participant Flow|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447874|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
447875|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
447876|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
447877|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
447878|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
447879|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
447880|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
447881|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
447882|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
447883|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
447884|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
447885|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
447886|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
447887|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
447888|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
447889|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
447890|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447891|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447892|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447893|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447894|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447895|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447896|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447897|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447898|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447899|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447900|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447901|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447902|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
448100|NCT00875836|B2|Baseline|Placebo|Placebo: 30 mg capsules twice daily
447903|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447904|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447905|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447906|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447907|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447908|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447909|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447910|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447911|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447912|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447913|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447914|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447915|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447916|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447917|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447918|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447919|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447920|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447921|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447922|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447923|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447924|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447925|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447926|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447927|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447928|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447929|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447930|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447931|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447932|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447933|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447934|NCT00876460|E8|Reported Event|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447935|NCT00876460|E7|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447936|NCT00876460|E6|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447937|NCT00876460|E5|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447938|NCT00876460|E4|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447939|NCT00876460|E3|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447940|NCT00876460|E2|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447941|NCT00876460|E1|Reported Event|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
447947|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447948|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447949|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447950|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447951|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447952|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447953|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447954|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447955|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447956|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447957|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447958|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447959|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447960|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447961|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447962|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447963|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447964|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447965|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447966|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447967|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447968|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447969|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447970|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447971|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447972|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447973|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447974|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447975|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447976|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
447977|NCT00876447|E26|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 13|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447978|NCT00876447|E25|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 13|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447979|NCT00876447|E24|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 12|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447980|NCT00876447|E23|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 12|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447981|NCT00876447|E22|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 11|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447982|NCT00876447|E21|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 11|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447983|NCT00876447|E20|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 10|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447984|NCT00876447|E19|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 10|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447985|NCT00876447|E18|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 9|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447986|NCT00876447|E17|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 9|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447987|NCT00876447|E16|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 8|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447988|NCT00876447|E15|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 8|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447989|NCT00876447|E14|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 7|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447990|NCT00876447|E13|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 7|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447991|NCT00876447|E12|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 6|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447992|NCT00876447|E11|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 6|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447993|NCT00876447|E10|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 5|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447994|NCT00876447|E9|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 5|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447995|NCT00876447|E8|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 4|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447996|NCT00876447|E7|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 4|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447997|NCT00876447|E6|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 3|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
447998|NCT00876447|E5|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 3|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
447999|NCT00876447|E4|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 2|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
448000|NCT00876447|E3|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 2|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
448001|NCT00876447|E2|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 1|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
448002|NCT00876447|E1|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 1|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
448003|NCT00876343|B4|Baseline|Total|Total of all reporting groups
448004|NCT00876343|B3|Baseline|Placebo Group|Placebo were administered orally once daily
448005|NCT00876343|B2|Baseline|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
448006|NCT00876343|B1|Baseline|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
448007|NCT00876343|P3|Participant Flow|Placebo Group|Placebo were administered orally once daily
448008|NCT00876343|P2|Participant Flow|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
448009|NCT00876343|P1|Participant Flow|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
448010|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
448011|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
448012|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
448013|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
448014|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
448015|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
448016|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
448017|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
448018|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
448019|NCT00876343|E3|Reported Event|Placebo Group|Placebo were administered orally once daily
448020|NCT00876343|E2|Reported Event|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
448021|NCT00876343|E1|Reported Event|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
448022|NCT00876265|B1|Baseline|Overall Study|
448023|NCT00876265|P1|Participant Flow|Overall Study|
448024|NCT00876265|O2|Outcome|Zyplast|Zyplast was injected into the opposite nasolabial fold that Belotero was injected into.
448025|NCT00876265|O1|Outcome|Belotero|Belotero was injected into the left or right nasolabial fold using a randomization schedule.
448026|NCT00876265|E2|Reported Event|Zyplast|
448027|NCT00876265|E1|Reported Event|Belotero|
448028|NCT00876018|B4|Baseline|Total|Total of all reporting groups
448029|NCT00876018|B3|Baseline|Control Group B (No Intervention)|Participants were not administered with any intervention.
448030|NCT00876018|B2|Baseline|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448031|NCT00876018|B1|Baseline|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448032|NCT00876018|P3|Participant Flow|Control Group B (No Intervention)|Participants were not administered with any intervention.
448101|NCT00875836|B1|Baseline|Buspirone|Buspirone: 30 mg capsules twice daily
453775|NCT00858403|O1|Outcome|Treatment With Dasatinib|
448033|NCT00876018|P2|Participant Flow|Control Group A (Un-fortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448034|NCT00876018|P1|Participant Flow|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40 gram (g) in 100 milliliter (mL) water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448035|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448036|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448037|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448038|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448039|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448040|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448041|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448042|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448043|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448044|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448045|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448046|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448047|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448048|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448049|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448050|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448051|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448052|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448053|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448054|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448055|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448056|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448057|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448058|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448059|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448060|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448061|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448062|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448063|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448064|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448065|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448066|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448067|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448068|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448069|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448070|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448071|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448072|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448073|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448074|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448075|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448076|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448077|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448078|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448079|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448080|NCT00876018|O3|Outcome|Control Group B (No Intervention)|Participants were not administered with any intervention.
448081|NCT00876018|O2|Outcome|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448082|NCT00876018|O1|Outcome|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448083|NCT00876018|E3|Reported Event|Control Group B (No Intervention)|Participants were not administered with any intervention.
448084|NCT00876018|E2|Reported Event|Control Group A (Unfortified Nutritional Powder)|Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448085|NCT00876018|E1|Reported Event|Experimental Group (Fortified Nutritional Supplement)|Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
448086|NCT00875979|B3|Baseline|Total|Total of all reporting groups
448087|NCT00875979|B2|Baseline|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448088|NCT00875979|B1|Baseline|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448089|NCT00875979|P2|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448090|NCT00875979|P1|Participant Flow|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448091|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448092|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448093|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448094|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448095|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448096|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448097|NCT00875979|E2|Reported Event|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448098|NCT00875979|E1|Reported Event|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
448099|NCT00875836|B3|Baseline|Total|Total of all reporting groups
448102|NCT00875836|P2|Participant Flow|Placebo|Placebo: Flexible dose up to 60mg/day
448103|NCT00875836|P1|Participant Flow|Buspirone|Buspirone: Flexible dose up to 60 mg/day
448104|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
448105|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
448106|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
448107|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
448108|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
448109|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
448110|NCT00875836|E2|Reported Event|Placebo|Placebo: Flexible dose up to 60mg/day
448111|NCT00875836|E1|Reported Event|Buspirone|Buspirone: Flexible dose up to 60 mg/day
448112|NCT00875810|B1|Baseline|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
448113|NCT00875810|P1|Participant Flow|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
448114|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
448115|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
448116|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
448117|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
448118|NCT00875810|E1|Reported Event|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
448119|NCT00875797|B3|Baseline|Total|Total of all reporting groups
448120|NCT00875797|B2|Baseline|Enteral Glutamine|enteral glutamine supplementation
448121|NCT00875797|B1|Baseline|Parenteral Glutamine|parenteral glutamine supplementation
448122|NCT00875797|P2|Participant Flow|Group E|Group E - group with enterally supplemented glutamine
448123|NCT00875797|P1|Participant Flow|Group P|Group P - group with parenterally supplemented glutamine
448124|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|enteral glutamine supplementation
448125|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|parenteral glutamine supplementation
448126|NCT00875797|O2|Outcome|Group - Enteral Glutamine|Group E - group with enterally supplemented glutamine
448127|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
448128|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|Group E - group with enterally supplemented glutamine
448129|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
448130|NCT00875797|E2|Reported Event|Group E|Group E - group with enterally supplemented glutamine
448131|NCT00875797|E1|Reported Event|Group P|Group P - group with parenterally supplemented glutamine
448132|NCT00875706|B4|Baseline|Total|Total of all reporting groups
448133|NCT00875706|B3|Baseline|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
448134|NCT00875706|B2|Baseline|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
448135|NCT00875706|B1|Baseline|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
448136|NCT00875706|P3|Participant Flow|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
448137|NCT00875706|P2|Participant Flow|Data Collection - Survey|"Survey data collection tools were piloted to assess feasibility of survey administration and development for use in a long-term care setting. These tools were piloted in sites where the educational intervention was administered.~The survey was a modified version of the Care Coordination Survey which was originally validated in a hospital setting (citation below). The survey pertains to work context factors that shape practice, including staffing and resources, communication and IT, participation in decision-making, relationships with supervisors, professional empowerment, and relational coordination. Modifications were made for use of the survey in a VA Community Living Centers.~Weinberg, D., J. Perloff, D. Cooney-Miner, and E. Glaser, Supporting work and workers: Validation of a hospital work organization survey for professional and paraprofessional workers. 2008."
448138|NCT00875706|P1|Participant Flow|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm.~Educational Intervention: The intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia."
448139|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
448140|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
448141|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
448142|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
448143|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
448144|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
448145|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
448146|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
448147|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
448148|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
448149|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
448150|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
448151|NCT00875706|E3|Reported Event|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
448152|NCT00875706|E2|Reported Event|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
448153|NCT00875706|E1|Reported Event|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
448154|NCT00875615|B1|Baseline|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
448155|NCT00875615|P1|Participant Flow|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
448156|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
448157|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
448158|NCT00875615|E1|Reported Event|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
448159|NCT00875589|B3|Baseline|Total|Total of all reporting groups
448160|NCT00875589|B2|Baseline|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
448161|NCT00875589|B1|Baseline|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
448162|NCT00875589|P2|Participant Flow|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
448163|NCT00875589|P1|Participant Flow|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
448164|NCT00875589|O2|Outcome|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
448165|NCT00875589|O1|Outcome|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
448166|NCT00875589|E2|Reported Event|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
448167|NCT00875589|E1|Reported Event|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
448168|NCT00875563|B1|Baseline|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
448169|NCT00875563|P1|Participant Flow|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
448170|NCT00875563|O1|Outcome|Zenith® Fenestrated AAA Endovascular Graft|
448171|NCT00875563|E1|Reported Event|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
448172|NCT00875550|B3|Baseline|Total|Total of all reporting groups
448173|NCT00875550|B2|Baseline|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448174|NCT00875550|B1|Baseline|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448175|NCT00875550|P2|Participant Flow|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448176|NCT00875550|P1|Participant Flow|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448177|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448178|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448179|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448180|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448181|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448182|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448183|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448184|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448185|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448186|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
448187|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448188|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448225|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448189|NCT00875550|E2|Reported Event|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448190|NCT00875550|E1|Reported Event|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
448191|NCT00875485|B3|Baseline|Total|Total of all reporting groups
448192|NCT00875485|B2|Baseline|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448193|NCT00875485|B1|Baseline|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448194|NCT00875485|P2|Participant Flow|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448195|NCT00875485|P1|Participant Flow|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448196|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448197|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448198|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448199|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448200|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448201|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448202|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448203|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448204|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448205|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448206|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448207|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448208|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448209|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448210|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448211|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448212|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448213|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448214|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448215|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448216|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448217|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448218|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448219|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448220|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448221|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448222|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448223|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448224|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448226|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448227|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448228|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448229|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448230|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448231|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448232|NCT00875485|E2|Reported Event|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
448233|NCT00875485|E1|Reported Event|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
448234|NCT00875433|B1|Baseline|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448235|NCT00875433|P1|Participant Flow|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448236|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448237|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448238|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448239|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448240|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448241|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448242|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448243|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448244|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448245|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448246|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448247|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448248|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448249|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448250|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448251|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448252|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448253|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448254|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448255|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448256|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448257|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448258|NCT00875433|E1|Reported Event|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
448259|NCT00875420|B6|Baseline|Total|Total of all reporting groups
448260|NCT00875420|B5|Baseline|Placebo|Oral once a day for 28 days
448261|NCT00875420|B4|Baseline|RAD1901 100 mg|Oral once a day for 28 days
448262|NCT00875420|B3|Baseline|RAD1901 50 mg|Oral once a day for 28 days
448263|NCT00875420|B2|Baseline|RAD1901 25 mg|Oral once a day for 28 days
448264|NCT00875420|B1|Baseline|RAD1901 10 mg|Oral once a day for 28 days
448265|NCT00875420|P5|Participant Flow|Placebo|Oral once a day for 28 days
448266|NCT00875420|P4|Participant Flow|RAD1901 100 mg|Oral once a day for 28 days
448267|NCT00875420|P3|Participant Flow|RAD1901 50 mg|Oral once a day for 28 days
448268|NCT00875420|P2|Participant Flow|RAD1901 25 mg|Oral once a day for 28 days
448269|NCT00875420|P1|Participant Flow|RAD1901 10 mg|Oral once a day for 28 days
448270|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
448271|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
448272|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
448273|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
448274|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
448275|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
448276|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
448277|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
448278|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
448279|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
448280|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
448281|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
448282|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
448283|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
448284|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
448285|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
448286|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
448287|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
448288|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
448289|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
448290|NCT00875420|E5|Reported Event|Placebo|Oral once a day for 28 days
448291|NCT00875420|E4|Reported Event|RAD1901 100 mg|Oral once a day for 28 days
448292|NCT00875420|E3|Reported Event|RAD1901 50 mg|Oral once a day for 28 days
448293|NCT00875420|E2|Reported Event|RAD1901 25 mg|Oral once a day for 28 days
448294|NCT00875420|E1|Reported Event|RAD1901 10 mg|Oral once a day for 28 days
448295|NCT00875394|B4|Baseline|Total|Total of all reporting groups
448296|NCT00875394|B3|Baseline|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448297|NCT00875394|B2|Baseline|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448298|NCT00875394|B1|Baseline|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
448299|NCT00875394|P3|Participant Flow|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448300|NCT00875394|P2|Participant Flow|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448301|NCT00875394|P1|Participant Flow|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
448302|NCT00875394|O3|Outcome|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448303|NCT00875394|O2|Outcome|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448304|NCT00875394|O1|Outcome|Sitagliptin + Metformin|Patients administered sitagliptin and metformin.
448305|NCT00875394|E3|Reported Event|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448306|NCT00875394|E2|Reported Event|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
448307|NCT00875394|E1|Reported Event|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
448308|NCT00875329|B1|Baseline|Group 1|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
448309|NCT00875329|P1|Participant Flow|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview.
448310|NCT00875329|O1|Outcome|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
448311|NCT00875329|E1|Reported Event|Convenience Sample|A convenience sample of 97 VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
448312|NCT00875212|B1|Baseline|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
448313|NCT00875212|P1|Participant Flow|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
448314|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a CaGP+Fluoride dentifrice
448315|NCT00875212|O3|Outcome|Fluoride|intrvention of using a 1,500 ppm fluoridated dentifrice
448316|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a CaGP dentifrice
448317|NCT00875212|O1|Outcome|Control|use of a placebo dentifrice (no fluoride and no CaGP). The volunteers were asked to use the placebo dentifrices for more one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
448318|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a dentifrice containing fluoride and calcium glycerophosphate
448319|NCT00875212|O3|Outcome|Fluoride|intervention of using a dentifrice with 1,500 ppm of fluoride
448320|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a dentifrice containing only calcium glycerophosphate (CaGP)
448321|NCT00875212|O1|Outcome|Control|intervention of using a dentifrice of no active ingredient. The volunteers were asked to use the placebo dentifrices for one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
448322|NCT00875212|E1|Reported Event|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
448323|NCT00875017|B7|Baseline|Total|Total of all reporting groups
448324|NCT00875017|B6|Baseline|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
448325|NCT00875017|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
448326|NCT00875017|B4|Baseline|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
453776|NCT00858403|O1|Outcome|Treatment With Dasatinib|
448327|NCT00875017|B3|Baseline|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
448328|NCT00875017|B2|Baseline|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
448329|NCT00875017|B1|Baseline|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
448330|NCT00875017|P6|Participant Flow|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
448331|NCT00875017|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
448332|NCT00875017|P4|Participant Flow|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
448333|NCT00875017|P3|Participant Flow|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
448334|NCT00875017|P2|Participant Flow|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
448335|NCT00875017|P1|Participant Flow|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
448336|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of calcium is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of calcium is measured.
448337|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
448338|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
448339|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
448340|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
448341|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of phosphorous is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of phosphorous is measured.
448342|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along wuith oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
448343|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
448344|NCT00875017|E4|Reported Event|Fasting|
448345|NCT00875017|E3|Reported Event|Meal Only|
448346|NCT00875017|E2|Reported Event|Sevelamer Carbonate|
448347|NCT00875017|E1|Reported Event|Lanthanum Carbonate|
448348|NCT00874939|B1|Baseline|All Participants|All enrolled participants
448349|NCT00874939|P1|Participant Flow|All Participants|All enrolled participants
448350|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448351|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448352|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
448353|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448354|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448355|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448356|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
448357|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448358|NCT00874939|E4|Reported Event|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448359|NCT00874939|E3|Reported Event|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
450507|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
448360|NCT00874939|E2|Reported Event|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
448361|NCT00874939|E1|Reported Event|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
448362|NCT00874887|B3|Baseline|Total|Total of all reporting groups
448363|NCT00874887|B2|Baseline|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448364|NCT00874887|B1|Baseline|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448365|NCT00874887|P2|Participant Flow|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448366|NCT00874887|P1|Participant Flow|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448367|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448368|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448369|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448370|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448371|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448372|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448373|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448374|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448375|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448376|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448377|NCT00874887|E2|Reported Event|Zymar®|Gatifloxacin 0.3% ophthalmic solution
448378|NCT00874887|E1|Reported Event|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
448379|NCT00874848|B3|Baseline|Total|Total of all reporting groups
448380|NCT00874848|B2|Baseline|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448381|NCT00874848|B1|Baseline|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448382|NCT00874848|P2|Participant Flow|Control Arm|"Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
448383|NCT00874848|P1|Participant Flow|Imprime PGG Arm|"Imprime PGG® infusion:~4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle;~Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
448384|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448385|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448386|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448387|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448388|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448389|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448390|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448391|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448392|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448393|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448394|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448395|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448396|NCT00874848|E2|Reported Event|Control Arm|Cetuximab + Paclitaxel/Carboplatin
448397|NCT00874848|E1|Reported Event|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
448398|NCT00874822|B1|Baseline|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
448399|NCT00874822|P1|Participant Flow|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
448400|NCT00874822|O1|Outcome|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
448401|NCT00874822|E1|Reported Event|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
448402|NCT00874770|B5|Baseline|Total|Total of all reporting groups
448403|NCT00874770|B4|Baseline|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448404|NCT00874770|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin|Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
453777|NCT00858403|O1|Outcome|Treatment With Dasatinib|
448405|NCT00874770|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin|Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448406|NCT00874770|B1|Baseline|Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448407|NCT00874770|P4|Participant Flow|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448408|NCT00874770|P3|Participant Flow|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448409|NCT00874770|P2|Participant Flow|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448410|NCT00874770|P1|Participant Flow|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448411|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets once daily for 48 weeks coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448412|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448413|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448414|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448415|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).48 weeks.
448416|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448417|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448418|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Riibavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448419|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448420|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448421|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448422|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
450510|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
448423|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weekswith pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448424|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448425|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448426|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448427|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448428|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448429|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448430|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448431|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448432|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448433|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448434|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Rribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448435|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448436|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448437|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448438|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448439|NCT00874770|E4|Reported Event|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448440|NCT00874770|E3|Reported Event|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448522|NCT00874510|O1|Outcome|Arm 1 - Standard Schedule for Years 1 and Year 2|interns work standard schedule, being on duty for 30 continuous hours
448441|NCT00874770|E2|Reported Event|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448442|NCT00874770|E1|Reported Event|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
448443|NCT00874549|B5|Baseline|Total|Total of all reporting groups
448444|NCT00874549|B4|Baseline|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448445|NCT00874549|B3|Baseline|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448446|NCT00874549|B2|Baseline|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448447|NCT00874549|B1|Baseline|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448448|NCT00874549|P4|Participant Flow|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448449|NCT00874549|P3|Participant Flow|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448450|NCT00874549|P2|Participant Flow|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448451|NCT00874549|P1|Participant Flow|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448452|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448453|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448454|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448455|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448456|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448457|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448458|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448459|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448460|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448461|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448462|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448463|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448464|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448465|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448466|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448601|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
448467|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448468|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448469|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448470|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448471|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448472|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448473|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448474|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448475|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448476|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448477|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448478|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448479|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448480|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448481|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448482|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448483|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448484|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448485|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448486|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448487|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448488|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448489|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448490|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448491|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448492|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448493|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448494|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448495|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448496|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448497|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448498|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448499|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448500|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448501|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448502|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448503|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448504|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448505|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448506|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448507|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448508|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
448509|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
448510|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
448511|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
448512|NCT00874549|E4|Reported Event|Menactra® Day 0 and Day 28|
448513|NCT00874549|E3|Reported Event|Menactra® Day 0 and Day 14|
448514|NCT00874549|E2|Reported Event|Menactra® Day 0 x 2|
448515|NCT00874549|E1|Reported Event|Menomune® Day 0|
448516|NCT00874510|B3|Baseline|Total|Total of all reporting groups
448517|NCT00874510|B2|Baseline|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
448518|NCT00874510|B1|Baseline|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
448519|NCT00874510|P2|Participant Flow|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
448520|NCT00874510|P1|Participant Flow|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
448521|NCT00874510|O2|Outcome|Arm 2 - Mandatory Nap|"In Year 1 interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am and were asked to nap during this time~For Year 2, the mandatory sign out of cell phones and cross-coverage responsibilities was split between two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am and were asked to nap during this time"
453778|NCT00858403|O1|Outcome|Treatment With Dasatinib|
448523|NCT00874510|E2|Reported Event|Arm 2 - Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
448524|NCT00874510|E1|Reported Event|Arm 1 - Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
448525|NCT00874497|B3|Baseline|Total|Total of all reporting groups
448526|NCT00874497|B2|Baseline|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448527|NCT00874497|B1|Baseline|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448528|NCT00874497|P2|Participant Flow|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448529|NCT00874497|P1|Participant Flow|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448530|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448531|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448532|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448533|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448534|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448535|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448536|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448537|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448538|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448539|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448540|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448541|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448542|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448543|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448544|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448545|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448546|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448547|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448548|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448549|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448550|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448551|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448552|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448553|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448554|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448555|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448556|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448557|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448558|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448559|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448560|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448561|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448562|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448563|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448564|NCT00874497|E2|Reported Event|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
448565|NCT00874497|E1|Reported Event|Tetomilast 25 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
448566|NCT00874276|B3|Baseline|Total|Total of all reporting groups
448567|NCT00874276|B2|Baseline|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
448568|NCT00874276|B1|Baseline|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
448569|NCT00874276|P2|Participant Flow|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
448570|NCT00874276|P1|Participant Flow|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
448571|NCT00874276|O2|Outcome|At Least One EGT Allele|At least one EGT allele
448572|NCT00874276|O1|Outcome|No EGT Allele|No EGT allele
448573|NCT00874276|O2|Outcome|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
448574|NCT00874276|O1|Outcome|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
448575|NCT00874276|E2|Reported Event|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
448576|NCT00874276|E1|Reported Event|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
448577|NCT00874250|B1|Baseline|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
448578|NCT00874250|P1|Participant Flow|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
448579|NCT00874250|O1|Outcome|GORE CTAG Device|GORE CTAG Device: Endovascular aortic stent-graft
448580|NCT00874250|O1|Outcome|GORE CTAG Device|GORE CTAG Device: Endovascular aortic stent-graft
448581|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
448582|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
448583|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
448584|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
448585|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
448586|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
448587|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
448588|NCT00874250|E1|Reported Event|CTAG Device Aneurysm Subjects|
448589|NCT00874120|B3|Baseline|Total|Total of all reporting groups
448590|NCT00874120|B2|Baseline|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
448591|NCT00874120|B1|Baseline|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
448592|NCT00874120|P2|Participant Flow|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
448593|NCT00874120|P1|Participant Flow|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
448594|NCT00874120|O2|Outcome|Placebo|Placebo twice daily for 7 days
448595|NCT00874120|O1|Outcome|Phenylephrine|Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
448596|NCT00874120|E2|Reported Event|Placebo|Placebo twice daily for 7 days
448597|NCT00874120|E1|Reported Event|Phenylephrine|Phenylephrine HCL Extended Release tablets 30 mg twice daily for 7 days
448598|NCT00874094|B1|Baseline|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
448599|NCT00874094|P1|Participant Flow|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
448600|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
450755|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
448602|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
448603|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
448604|NCT00874094|E1|Reported Event|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
448605|NCT00874029|B1|Baseline|Halt Medical Acessa Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient’s uterine fibroids and treat all of her fibroids, and just the fibroids.
448606|NCT00874029|P1|Participant Flow|Halt Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
448607|NCT00874029|O2|Outcome|How Effective Was This Treatment in Eliminating Symptoms|Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.
448608|NCT00874029|O1|Outcome|Overall, Satisfaction With Uterine Fibroid Treatment|Patients were asked, overall, how satisfied with their uterine fibroid treatment.
448609|NCT00874029|O1|Outcome|Full Analysis Set - Month 12 Health Status Change|All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.
448610|NCT00874029|O2|Outcome|Full Analysis Set - Health Related Quality of Life (HRQL)|All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.
448611|NCT00874029|O1|Outcome|Full Analysis Set - Symptom Severity|All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.
448612|NCT00874029|O2|Outcome|Change in Fibroid Volume|Fibroid volume assessment 12 months post treatment via contrast enhanced MRI
448613|NCT00874029|O1|Outcome|Change in Uterine Volume|Uterine volume assessment 12 months post treatment via contrast enhanced MRI
448614|NCT00874029|O1|Outcome|Surgical Reintervention 12 Months Post Treatment|The Per Protocol Set was the primary analysis set for surgical reintervention.
448615|NCT00874029|O2|Outcome|Procedural|Procedure-related events are those that the investigator considered to be definitely, probably, or possibly related to the procedure, including those related to abdominal entry and anesthesia.
448616|NCT00874029|O1|Outcome|Device Related Adverse Events|Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.
448617|NCT00874029|O1|Outcome|Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment|"Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered evaluable in terms of their 1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle, 3) baseline menstrual blood loss was within protocol inclusion limits."
448618|NCT00874029|E1|Reported Event|Safety Set|The Safety Set consisted of all subjects treated in the study.
448619|NCT00873912|B3|Baseline|Total|Total of all reporting groups
448620|NCT00873912|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448621|NCT00873912|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448622|NCT00873912|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448623|NCT00873912|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448624|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448625|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448626|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448627|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448628|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448656|NCT00873873|E1|Reported Event|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
448629|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448630|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448631|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448632|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448633|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448634|NCT00873912|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
448635|NCT00873912|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
448636|NCT00873873|B5|Baseline|Total|Total of all reporting groups
448637|NCT00873873|B4|Baseline|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
448638|NCT00873873|B3|Baseline|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
448639|NCT00873873|B2|Baseline|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
448640|NCT00873873|B1|Baseline|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
448641|NCT00873873|P4|Participant Flow|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
448642|NCT00873873|P3|Participant Flow|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
448643|NCT00873873|P2|Participant Flow|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
448644|NCT00873873|P1|Participant Flow|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
448645|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
448646|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
448647|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
448648|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
448649|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
448650|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
448651|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
448652|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
448653|NCT00873873|E4|Reported Event|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
448654|NCT00873873|E3|Reported Event|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
448655|NCT00873873|E2|Reported Event|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
448657|NCT00873860|B5|Baseline|Total|Total of all reporting groups
448658|NCT00873860|B4|Baseline|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448659|NCT00873860|B3|Baseline|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448660|NCT00873860|B2|Baseline|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448661|NCT00873860|B1|Baseline|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448662|NCT00873860|P4|Participant Flow|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448663|NCT00873860|P3|Participant Flow|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448664|NCT00873860|P2|Participant Flow|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448665|NCT00873860|P1|Participant Flow|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448666|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448667|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448668|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448669|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448670|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448671|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448672|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448673|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448674|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448675|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448676|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448677|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448678|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448679|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448680|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448681|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448682|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448683|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448684|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448685|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448686|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448687|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448688|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448689|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448690|NCT00873860|O3|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448691|NCT00873860|O2|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448692|NCT00873860|O1|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448693|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448694|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448695|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448696|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448697|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448698|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448699|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448700|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448701|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448702|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448703|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
453779|NCT00858403|E1|Reported Event|Treatment With Dasatinib|
448704|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448705|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448706|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448707|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448708|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448709|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448710|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448711|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448712|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448713|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448714|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448715|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448716|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448717|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448718|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448719|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448720|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448721|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448722|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448723|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448724|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448725|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448726|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448727|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448728|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448729|NCT00873860|E4|Reported Event|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448730|NCT00873860|E3|Reported Event|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448731|NCT00873860|E2|Reported Event|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448732|NCT00873860|E1|Reported Event|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
448733|NCT00873821|B3|Baseline|Total|Total of all reporting groups
448734|NCT00873821|B2|Baseline|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
448735|NCT00873821|B1|Baseline|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
448736|NCT00873821|P2|Participant Flow|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
448737|NCT00873821|P1|Participant Flow|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
448738|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
448739|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
448740|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
453780|NCT00858390|B3|Baseline|Total|Total of all reporting groups
448741|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
448742|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
448743|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
448744|NCT00873821|E2|Reported Event|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
448745|NCT00873821|E1|Reported Event|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
448746|NCT00873782|B1|Baseline|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
448747|NCT00873782|P1|Participant Flow|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
448748|NCT00873782|O1|Outcome|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
448749|NCT00873782|E1|Reported Event|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
448750|NCT00873730|B3|Baseline|Total|Total of all reporting groups
448751|NCT00873730|B2|Baseline|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448752|NCT00873730|B1|Baseline|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448753|NCT00873730|P2|Participant Flow|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448754|NCT00873730|P1|Participant Flow|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448755|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448756|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448757|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448758|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448759|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448760|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448761|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448762|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448763|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448764|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448765|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448766|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448767|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448768|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
450756|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
448769|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448770|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448771|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448772|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448773|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448774|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448775|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448776|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448777|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448778|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448779|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448780|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448781|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448782|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448783|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448784|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448785|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448786|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448787|NCT00873730|E2|Reported Event|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
448788|NCT00873730|E1|Reported Event|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
448789|NCT00873457|B1|Baseline|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
448790|NCT00873457|P1|Participant Flow|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
448791|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
448792|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
448793|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
448794|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
448795|NCT00873457|E1|Reported Event|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
448796|NCT00873366|B1|Baseline|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448797|NCT00873366|P1|Participant Flow|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448798|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448799|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448800|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448801|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448802|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448803|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448804|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448805|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448806|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448807|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448808|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448809|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
449028|NCT00872898|E3|Reported Event|Memantine - Part One, Open Label Treatment|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
448810|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448811|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448812|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448813|NCT00873366|O1|Outcome|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448814|NCT00873366|E1|Reported Event|¹³C-DM-BT|Participants who have provided blood samples and underwent a ¹³Cdextromethorphan breath test (¹³C-DM-BT) on day 1, once during week 8-10 following initiation of tamoxifen, and once during either month 5-6 post tamoxifen initiation.
448815|NCT00873327|B1|Baseline|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
448816|NCT00873327|P1|Participant Flow|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days postnatal age (PNA) 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation (GA) at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
448817|NCT00873327|O1|Outcome|PK Analysis Cohort - Piperacillin Plasma Clearance|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
448818|NCT00873327|E1|Reported Event|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
448819|NCT00873119|B3|Baseline|Total|Total of all reporting groups
448820|NCT00873119|B2|Baseline|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448821|NCT00873119|B1|Baseline|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448822|NCT00873119|P2|Participant Flow|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448823|NCT00873119|P1|Participant Flow|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448824|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448825|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448826|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448827|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448828|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448829|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448830|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448908|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448831|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448832|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448833|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448834|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448835|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448836|NCT00873119|E2|Reported Event|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
448837|NCT00873119|E1|Reported Event|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
448838|NCT00873093|B6|Baseline|Total|Total of all reporting groups
448839|NCT00873093|B5|Baseline|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448840|NCT00873093|B4|Baseline|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448841|NCT00873093|B3|Baseline|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448842|NCT00873093|B2|Baseline|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448843|NCT00873093|B1|Baseline|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448844|NCT00873093|P5|Participant Flow|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448845|NCT00873093|P4|Participant Flow|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448846|NCT00873093|P3|Participant Flow|Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448847|NCT00873093|P2|Participant Flow|Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448927|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448848|NCT00873093|P1|Participant Flow|Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448849|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448850|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448851|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448852|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448853|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448854|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448855|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448928|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448856|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448857|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448858|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448859|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448860|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448861|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448862|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448872|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
449025|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
448863|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448864|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448865|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448866|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448867|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448868|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
448869|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448870|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448871|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448929|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448873|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448874|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448875|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448876|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448877|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448878|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448879|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448880|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448881|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448882|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448883|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448884|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
448885|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
448886|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448887|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448888|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448889|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448890|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448891|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448892|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448893|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448894|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448895|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448896|NCT00873093|E5|Reported Event|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448897|NCT00873093|E4|Reported Event|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448898|NCT00873093|E3|Reported Event|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448899|NCT00873093|E2|Reported Event|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448900|NCT00873093|E1|Reported Event|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
448901|NCT00873041|B4|Baseline|Total|Total of all reporting groups
448902|NCT00873041|B3|Baseline|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448903|NCT00873041|B2|Baseline|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448904|NCT00873041|B1|Baseline|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448905|NCT00873041|P3|Participant Flow|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448906|NCT00873041|P2|Participant Flow|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448907|NCT00873041|P1|Participant Flow|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
449026|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
448909|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448910|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448911|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448912|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448913|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448914|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448915|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448916|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448917|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448918|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448919|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448920|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448921|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448922|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448923|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448924|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448925|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448926|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
449023|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
448930|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448931|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448932|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448933|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448934|NCT00873041|O1|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448935|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448936|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448937|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448938|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448939|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448940|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448941|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448942|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448943|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448944|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448945|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448946|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448947|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448948|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448949|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448950|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
449024|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449027|NCT00872898|O1|Outcome|Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
448951|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448952|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448953|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448954|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448955|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448956|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
448957|NCT00873041|E3|Reported Event|Placebo/Deferasirox Any Dose|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448958|NCT00873041|E2|Reported Event|Deferasirox 10 mg/kg/Day|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448959|NCT00873041|E1|Reported Event|Deferasirox 5 mg/kg/Day|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
448960|NCT00873015|B5|Baseline|Total|Total of all reporting groups
448961|NCT00873015|B4|Baseline|64 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 64 nmol/min/kg
448962|NCT00873015|B3|Baseline|48 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 48 nmol/min/kg
448963|NCT00873015|B2|Baseline|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
448964|NCT00873015|B1|Baseline|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion 32 nmol/min/kg
448965|NCT00873015|P4|Participant Flow|Nitrite 64 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 64 nmol/min/kg
448966|NCT00873015|P3|Participant Flow|Nitrite 48 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 48 nmol/min/kg
448967|NCT00873015|P2|Participant Flow|Nitrite 32 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 32 nmol/min/kg
448968|NCT00873015|P1|Participant Flow|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
448969|NCT00873015|O3|Outcome|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 32 nmol/min/kg
448970|NCT00873015|O2|Outcome|48 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 48 nmol/min/kg
448971|NCT00873015|O1|Outcome|64 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 64 nmol/min/kg
448972|NCT00873015|E2|Reported Event|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
448973|NCT00873015|E1|Reported Event|Nitrite|Sodium nitrite : 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
448974|NCT00872989|B3|Baseline|Total|Total of all reporting groups
448975|NCT00872989|B2|Baseline|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448976|NCT00872989|B1|Baseline|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448977|NCT00872989|P2|Participant Flow|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448978|NCT00872989|P1|Participant Flow|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448979|NCT00872989|O1|Outcome|Vandetanib|Patients elected to participant in the crossover registration in Vandetanib after progression in single agent docetaxel.
448980|NCT00872989|O1|Outcome|Vandetanib|Vandetanib treated patients
448981|NCT00872989|O3|Outcome|Vandetanib|
448982|NCT00872989|O2|Outcome|Docetaxel + Vandetanib|
448983|NCT00872989|O1|Outcome|Docetaxel|
448984|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448985|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448986|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448987|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448988|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448989|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
448990|NCT00872989|E3|Reported Event|Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
448991|NCT00872989|E2|Reported Event|Docetaxel + Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
448992|NCT00872989|E1|Reported Event|Docetaxel|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
448993|NCT00872898|B4|Baseline|Total|Total of all reporting groups
448994|NCT00872898|B3|Baseline|Part Two - Memantine|Once daily oral administration of memantine extended release for 12 weeks. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
448995|NCT00872898|B2|Baseline|Part Two - Placebo|Once daily oral administration of placebo for 12 weeks.
448996|NCT00872898|B1|Baseline|Part One - Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
448997|NCT00872898|P2|Participant Flow|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
448998|NCT00872898|P1|Participant Flow|Placebo|Once daily, oral administration of placebo for 12 weeks.
448999|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449000|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449001|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449002|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449003|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449004|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449005|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449006|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449007|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449008|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449009|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449010|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449011|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449012|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449013|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449014|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449015|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449016|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449017|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449018|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
449019|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449020|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
449021|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
449022|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
449029|NCT00872898|E2|Reported Event|Memantine - Part Two, Double-Blind Treatment|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups."
449030|NCT00872898|E1|Reported Event|Placebo - Part Two, Double-Blind Treatment|Once daily oral administration of placebo for 12 weeks
449031|NCT00872833|B1|Baseline|Overall|Both cohorts combined
449032|NCT00872833|P2|Participant Flow|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
449033|NCT00872833|P1|Participant Flow|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
449034|NCT00872833|O4|Outcome|> 28 Days|Subjects with transfusion cycles greater than 28 days
449035|NCT00872833|O3|Outcome|22 - 28 Days|Subjects with transfusion cycles between 22 and 28 days
449036|NCT00872833|O2|Outcome|15 - 21 Days|Subjects with transfusion cycles between 15 and 21 days
449037|NCT00872833|O1|Outcome|<= 14 Days|Subjects with transfusion cycles of 14 days or less
449038|NCT00872833|O2|Outcome|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
449039|NCT00872833|O1|Outcome|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
449040|NCT00872833|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected as part of this observational study.
449041|NCT00872729|B1|Baseline|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg.
449042|NCT00872729|P1|Participant Flow|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg; Single-dose, open-label, nonrandomized, 2-period, crossover study of cysteamine bitartrate delayed-release capsules (RP103) and Cystagon®. Subjects were enrolled sequentially and received Cystagon® first followed by RP103.
449043|NCT00872729|O20|Outcome|RP103 (12 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449044|NCT00872729|O19|Outcome|Cystagon® (12 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449045|NCT00872729|O18|Outcome|RP103 (10 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449046|NCT00872729|O17|Outcome|Cystagon® (10 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449047|NCT00872729|O16|Outcome|RP103 (8 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449048|NCT00872729|O15|Outcome|Cystagon® (8 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449049|NCT00872729|O14|Outcome|RP103 (6 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449050|NCT00872729|O13|Outcome|Cystagon® (6 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449051|NCT00872729|O12|Outcome|RP103 (4 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449052|NCT00872729|O11|Outcome|Cystagon® (4 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449053|NCT00872729|O10|Outcome|RP103 (3 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449054|NCT00872729|O9|Outcome|Cystagon® (3 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449055|NCT00872729|O8|Outcome|RP103 (2.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449056|NCT00872729|O7|Outcome|Cystagon® (2.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449057|NCT00872729|O6|Outcome|RP103 (2 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449058|NCT00872729|O5|Outcome|Cystagon® (2 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449059|NCT00872729|O4|Outcome|RP103 (1 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449060|NCT00872729|O3|Outcome|Cystagon® (1 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449061|NCT00872729|O2|Outcome|RP103 (0.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449062|NCT00872729|O1|Outcome|Cystagon® (0.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449063|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449064|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449065|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449066|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449067|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
449068|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
449069|NCT00872729|E2|Reported Event|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg
449070|NCT00872729|E1|Reported Event|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg;
449071|NCT00872599|B1|Baseline|Study Group|
449072|NCT00872599|P2|Participant Flow|Fenofibrate, Then Placebo|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received fenofibrate 160mg/d. During the second they received matching placebo.
449073|NCT00872599|P1|Participant Flow|Placebo, Then Fenofibrate|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received matching placebo. During the second they received fenofibrate 160mg/d.
449074|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
449145|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
449075|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
449076|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
449077|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
449078|NCT00872599|E2|Reported Event|Fenofibrate|
449079|NCT00872599|E1|Reported Event|Placebo|
449080|NCT00872534|B3|Baseline|Total|Total of all reporting groups
449081|NCT00872534|B2|Baseline|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
449082|NCT00872534|B1|Baseline|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
449083|NCT00872534|P2|Participant Flow|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
449084|NCT00872534|P1|Participant Flow|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
449085|NCT00872534|O2|Outcome|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
449086|NCT00872534|O1|Outcome|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
449087|NCT00872534|E2|Reported Event|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
449088|NCT00872534|E1|Reported Event|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
449089|NCT00872521|B4|Baseline|Total|Total of all reporting groups
449090|NCT00872521|B3|Baseline|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449091|NCT00872521|B2|Baseline|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449092|NCT00872521|B1|Baseline|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449093|NCT00872521|P3|Participant Flow|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449094|NCT00872521|P2|Participant Flow|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449095|NCT00872521|P1|Participant Flow|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449096|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
449097|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
449098|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
449099|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
449100|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
449101|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
449102|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
449103|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
449104|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
449105|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
449106|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
449107|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
449108|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
449109|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
449110|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
449111|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
449112|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449113|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449114|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449115|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449116|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449146|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
450757|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
449117|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449118|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449119|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449120|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449121|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449122|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449123|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449124|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449125|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449126|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449127|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449128|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449129|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449130|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449131|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449132|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449133|NCT00872521|O3|Outcome|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449134|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449135|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449136|NCT00872521|E4|Reported Event|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449137|NCT00872521|E3|Reported Event|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449138|NCT00872521|E2|Reported Event|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449139|NCT00872521|E1|Reported Event|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
449140|NCT00872430|B3|Baseline|Total|Total of all reporting groups
449141|NCT00872430|B2|Baseline|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
449142|NCT00872430|B1|Baseline|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
449143|NCT00872430|P2|Participant Flow|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
449144|NCT00872430|P1|Participant Flow|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
449227|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
449147|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
449148|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
449149|NCT00872339|B4|Baseline|Total|Total of all reporting groups
449150|NCT00872339|B3|Baseline|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
449151|NCT00872339|B2|Baseline|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
449152|NCT00872339|B1|Baseline|Transfusion-dependant|People with transfusion-dependant thalassemia.
449153|NCT00872339|P3|Participant Flow|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
449154|NCT00872339|P2|Participant Flow|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
449155|NCT00872339|P1|Participant Flow|Transfusion-dependant|People with transfusion-dependant thalassemia.
449156|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
449157|NCT00872339|O1|Outcome|All Subjects Combined|Subjects were combined into one group.
449158|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
449159|NCT00872339|O3|Outcome|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
449160|NCT00872339|O2|Outcome|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
449161|NCT00872339|O1|Outcome|Transfusion-dependant|People with transfusion-dependant thalassemia.
449162|NCT00872339|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected for this study.
449163|NCT00872170|B3|Baseline|Total|Total of all reporting groups
449164|NCT00872170|B2|Baseline|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
449165|NCT00872170|B1|Baseline|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449166|NCT00872170|P2|Participant Flow|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
449167|NCT00872170|P1|Participant Flow|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449168|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449169|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449170|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449171|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449172|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449173|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449174|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449175|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449176|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
454209|NCT00857623|E2|Reported Event|Placebo|Capsule, once daily
449177|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449178|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449179|NCT00872170|E2|Reported Event|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
449180|NCT00872170|E1|Reported Event|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
449181|NCT00872079|B1|Baseline|Genomics|"The specific aims of this research are:~Determine the structure and the type of neural network model for predictions from historically obtained data. (Computer Model)~Prospectively develop an individualized neural network and NONMEM model capable of predicting erythropoietin dosing for chronic in-center hemodialysis patients using adaptive techniques.~Develop computer programs based on neural computing that can be used in a clinical setting. (Computer Model)~Determine the utility of the computer programs prospectively in the clinical setting."
449182|NCT00872079|P1|Participant Flow|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
449183|NCT00872079|O1|Outcome|Genomics|"Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.~There are 4 Aims in this study.~To collect historical data on warfarin dosing in subjects.~To collect genotype information on up to 300 subjects receiving warfarin anticoagulation.~to develop a computer model incorporating the information from aim 1 and aim 2.~To conduct a randomized clinical trial."
449184|NCT00872079|E1|Reported Event|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
449185|NCT00872027|B3|Baseline|Total|Total of all reporting groups
449186|NCT00872027|B2|Baseline|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
449187|NCT00872027|B1|Baseline|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
449188|NCT00872027|P2|Participant Flow|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
449189|NCT00872027|P1|Participant Flow|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
449190|NCT00872027|O2|Outcome|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
449191|NCT00872027|O1|Outcome|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
449192|NCT00872027|E2|Reported Event|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
449193|NCT00872027|E1|Reported Event|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
449194|NCT00872001|B3|Baseline|Total|Total of all reporting groups
449195|NCT00872001|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
449196|NCT00872001|B1|Baseline|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
449197|NCT00872001|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
449198|NCT00872001|P1|Participant Flow|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
449199|NCT00872001|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
449200|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
449201|NCT00872001|O2|Outcome|Placebo|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.
449202|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).
449203|NCT00872001|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
449204|NCT00872001|E1|Reported Event|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
449205|NCT00871975|B1|Baseline|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
449206|NCT00871975|P1|Participant Flow|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
449207|NCT00871975|O1|Outcome|Urodynamics + Tetra NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
449208|NCT00871975|E1|Reported Event|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
449209|NCT00871871|B3|Baseline|Total|Total of all reporting groups
449210|NCT00871871|B2|Baseline|All Part II Participants|Part II Overall: Isosorbide mononitrate (ISMN)in Period 1, followed by placebo in Period 2 or placebo in Period 1, followed by ISMN in Period 2
449211|NCT00871871|B1|Baseline|All Part I Participants|Part I Overall: Hydrochlorothiazide (HCTZ) in Period 1 followed by Placebo in Period 2 or Placebo in Period 1, followed by HCTZ in Period 2
449212|NCT00871871|P4|Participant Flow|ISMN Placebo First, Then ISMN|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
449213|NCT00871871|P3|Participant Flow|ISMN First, Then ISMN Placebo|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
449214|NCT00871871|P2|Participant Flow|HCTZ Placebo First, Then HCTZ|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
449215|NCT00871871|P1|Participant Flow|HCTZ First, Then HCTZ Placebo|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
449216|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
449217|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
449218|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
449219|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
449220|NCT00871871|O2|Outcome|Isosorbide Mononitrate (ISMN) Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
449221|NCT00871871|O1|Outcome|Isosorbide Mononitrate (ISMN)|Part II: Participants on ISMN in either Period 1 or Period 2
449222|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
449223|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
449224|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
449225|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
449226|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
454624|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
449228|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
449229|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
449230|NCT00871871|E4|Reported Event|ISMN Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
449231|NCT00871871|E3|Reported Event|ISMN|Part II: Participants on ISMN in either Period 1 or Period 2
449232|NCT00871871|E2|Reported Event|HCTZ Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
449233|NCT00871871|E1|Reported Event|HCTZ|Part I: Participants on HCTZ in either Period 1 or Period 2
449234|NCT00871819|B1|Baseline|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
449235|NCT00871819|P1|Participant Flow|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
449236|NCT00871819|O1|Outcome|All Subjects|All enrolled subjects
449237|NCT00871819|E1|Reported Event|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
449238|NCT00871780|B1|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449239|NCT00871780|P1|Participant Flow|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449240|NCT00871780|O3|Outcome|Natalizumab: Baseline EDSS >= 4.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS >= 4.5
449241|NCT00871780|O2|Outcome|Natalizumab: Baseline EDSS 3.0 to 4.0|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS 3.0 to 4.0
449242|NCT00871780|O1|Outcome|Natalizumab: Baseline EDSS 0 to 2.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS of 0 to 2.5
449243|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449244|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449245|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449246|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449247|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449248|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449249|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449250|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449251|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449252|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449253|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449254|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449255|NCT00871780|E1|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
449256|NCT00871741|B3|Baseline|Total|Total of all reporting groups
449257|NCT00871741|B2|Baseline|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449258|NCT00871741|B1|Baseline|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449259|NCT00871741|P2|Participant Flow|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449260|NCT00871741|P1|Participant Flow|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449261|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449262|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449263|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449264|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449265|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449266|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449267|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449268|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449269|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449270|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449271|NCT00871741|E2|Reported Event|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449272|NCT00871741|E1|Reported Event|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
449273|NCT00871728|B1|Baseline|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449274|NCT00871728|P1|Participant Flow|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449275|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449276|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449277|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449278|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449279|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449280|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449281|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449282|NCT00871728|E1|Reported Event|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
449283|NCT00871715|B4|Baseline|Total|Total of all reporting groups
449284|NCT00871715|B3|Baseline|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
449285|NCT00871715|B2|Baseline|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
449286|NCT00871715|B1|Baseline|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
449287|NCT00871715|P3|Participant Flow|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
449288|NCT00871715|P2|Participant Flow|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
449346|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
457211|NCT00852917|B1|Baseline|1: Tramadol Once A Day 100mg|
449289|NCT00871715|P1|Participant Flow|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
449290|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
449291|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
449292|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
449293|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
449294|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
449295|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
449296|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
449297|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
449298|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
449299|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
449347|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449348|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449300|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
449301|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
449302|NCT00871715|E4|Reported Event|Screened But Not Randomized|Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
449303|NCT00871715|E3|Reported Event|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
449304|NCT00871715|E2|Reported Event|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
449305|NCT00871715|E1|Reported Event|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
449306|NCT00871689|B1|Baseline|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449307|NCT00871689|P1|Participant Flow|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449308|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449309|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449310|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449311|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449312|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449349|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449989|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
449313|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449314|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449315|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449316|NCT00871689|E1|Reported Event|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
449317|NCT00871624|B3|Baseline|Total|Total of all reporting groups
449318|NCT00871624|B2|Baseline|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449319|NCT00871624|B1|Baseline|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449320|NCT00871624|P2|Participant Flow|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449321|NCT00871624|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449322|NCT00871624|O2|Outcome|Placebo|"Subjects received placebo saline solution 0.2-0.7 mcg/kg/hr~Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4."
449323|NCT00871624|O1|Outcome|Dexmedetomidine|"Subjects received active dexmedetomidine 0.2 -0.7 mcg/kg/hr~Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4."
449324|NCT00871624|O2|Outcome|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449325|NCT00871624|O1|Outcome|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449326|NCT00871624|E2|Reported Event|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449327|NCT00871624|E1|Reported Event|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
449328|NCT00871572|B5|Baseline|Total|Total of all reporting groups
449329|NCT00871572|B4|Baseline|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449330|NCT00871572|B3|Baseline|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449331|NCT00871572|B2|Baseline|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449332|NCT00871572|B1|Baseline|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449333|NCT00871572|P4|Participant Flow|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449334|NCT00871572|P3|Participant Flow|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449335|NCT00871572|P2|Participant Flow|10 mg LY2409021|10 milligram (mg) LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449336|NCT00871572|P1|Participant Flow|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449337|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449338|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449339|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449340|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449341|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449342|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449343|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449344|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449345|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
450758|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
449350|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449351|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449352|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449353|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449354|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449355|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449356|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449357|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449358|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449359|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449360|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449361|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449362|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449363|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449364|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449365|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449366|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449367|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449368|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449369|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449370|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449371|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449372|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449373|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449374|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449375|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449376|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449377|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449378|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449379|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449380|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449381|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449382|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449383|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449384|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449385|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449386|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449387|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449388|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449389|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449390|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449391|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449392|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449393|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449394|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449395|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449396|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449397|NCT00871572|O4|Outcome|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449398|NCT00871572|O3|Outcome|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449399|NCT00871572|O2|Outcome|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449400|NCT00871572|O1|Outcome|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449401|NCT00871572|E4|Reported Event|60 mg LY2409021|60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
449402|NCT00871572|E3|Reported Event|30 mg LY2409021|30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
449403|NCT00871572|E2|Reported Event|10 mg LY2409021|10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
449404|NCT00871572|E1|Reported Event|Placebo|Placebo was administered orally once daily as 4 capsules for 12 weeks.
449405|NCT00871494|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
449406|NCT00871494|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
449407|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
449408|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
449409|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
449410|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
449411|NCT00871494|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
449412|NCT00871429|B1|Baseline|Cancer Patients Using Lindi Skin Products|
449413|NCT00871429|P1|Participant Flow|Lindi Skin Participant Flow|
449414|NCT00871429|O3|Outcome|Lindi Skin Face Serum (Product B)|
449415|NCT00871429|O2|Outcome|Lindi Skin Face Wash (Product C)|
449416|NCT00871429|O1|Outcome|Lindi Skin Soothing Balm (Product A)|
449417|NCT00871429|E3|Reported Event|Lindi Skin Face Serum (Product B)|
449418|NCT00871429|E2|Reported Event|Lindi Skin Face Wash (Product C)|
449419|NCT00871429|E1|Reported Event|Lindi Skin Soothing Balm (Product A)|
449420|NCT00871403|B4|Baseline|Total|Total of all reporting groups
449421|NCT00871403|B3|Baseline|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
449422|NCT00871403|B2|Baseline|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
449423|NCT00871403|B1|Baseline|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
449424|NCT00871403|P3|Participant Flow|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
449425|NCT00871403|P2|Participant Flow|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
449426|NCT00871403|P1|Participant Flow|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
449427|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
449428|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
449429|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
449990|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
449430|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
449431|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
449432|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
449433|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
449434|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
449435|NCT00871403|E3|Reported Event|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
449436|NCT00871403|E2|Reported Event|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
449437|NCT00871403|E1|Reported Event|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
449438|NCT00871377|B1|Baseline|Baseline|The study began on Visit 1 when baseline data was collected and Intervention 1 was initiated.
449439|NCT00871377|P6|Participant Flow|H P L|High Dose, then Placebo, then Low Dose
449440|NCT00871377|P5|Participant Flow|H L P|High Dose, then Low Dose, then Placebo
449441|NCT00871377|P4|Participant Flow|L P H|Low Dose, then Placebo, then High Dose
449442|NCT00871377|P3|Participant Flow|L H P|Low Dose, then High Dose, then Placebo
449443|NCT00871377|P2|Participant Flow|P H L|Placebo, then High Dose, then Low Dose
449444|NCT00871377|P1|Participant Flow|P L H|Placebo, then Low Dose, then High Dose
449445|NCT00871377|O3|Outcome|Fish OIl High Dose|Fish Oil - 6 capsules per day EPA+DHA = 2160 mg/day
449446|NCT00871377|O2|Outcome|Fish Oil Low Dose|Fish Oil - 3 capsules per day Corn Oil - 3 capsules per day EPA+DHA = 1080 mg/day
449447|NCT00871377|O1|Outcome|Placebo|Corn Oil - 6 capsules per day
449448|NCT00871377|E3|Reported Event|Placebo|Corn Oil Placebo
449449|NCT00871377|E2|Reported Event|Low Dose|Low Dose Fish Oil Intervention
449450|NCT00871377|E1|Reported Event|High Dose|High Dose Fish Oil Intervention
449451|NCT00871351|B4|Baseline|Total|Total of all reporting groups
449452|NCT00871351|B3|Baseline|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449453|NCT00871351|B2|Baseline|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449454|NCT00871351|B1|Baseline|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449455|NCT00871351|P3|Participant Flow|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449456|NCT00871351|P2|Participant Flow|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449457|NCT00871351|P1|Participant Flow|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449458|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449459|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449460|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449461|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449462|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
457212|NCT00852917|P4|Participant Flow|4: Placebo|
449463|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449464|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449465|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449466|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449467|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449468|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449469|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449470|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449471|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449472|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449473|NCT00871351|E3|Reported Event|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449474|NCT00871351|E2|Reported Event|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449475|NCT00871351|E1|Reported Event|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
449476|NCT00871338|B3|Baseline|Total|Total of all reporting groups
449477|NCT00871338|B2|Baseline|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449478|NCT00871338|B1|Baseline|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449479|NCT00871338|P2|Participant Flow|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449480|NCT00871338|P1|Participant Flow|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449481|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449482|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449483|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449484|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449991|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
449485|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449486|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449487|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449488|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449489|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449490|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449491|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449492|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449493|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449494|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449495|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449496|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449497|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449710|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449498|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449499|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449500|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449501|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449502|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449503|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449504|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449505|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449506|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449507|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449508|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449509|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449510|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449606|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449511|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449512|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449513|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449514|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449515|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449516|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449517|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449518|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449519|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449520|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449521|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449522|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449523|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449773|NCT00870584|P2|Participant Flow|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
457213|NCT00852917|P3|Participant Flow|3: Tramadol Once A Day 300mg|
449524|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449525|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449526|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449527|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449528|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449529|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449530|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449531|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449532|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449533|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449534|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449535|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449536|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449607|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449537|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449538|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449539|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449540|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449541|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449542|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449543|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449544|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449545|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449546|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449547|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449548|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449549|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449832|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449550|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449551|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449552|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449553|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449554|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449555|NCT00871338|E2|Reported Event|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
449556|NCT00871338|E1|Reported Event|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
449557|NCT00871286|B3|Baseline|Total|Total of all reporting groups
449558|NCT00871286|B2|Baseline|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
449559|NCT00871286|B1|Baseline|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
449560|NCT00871286|P2|Participant Flow|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
449561|NCT00871286|P1|Participant Flow|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
449562|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
449563|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
449564|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
449565|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
449566|NCT00871286|E2|Reported Event|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
449567|NCT00871286|E1|Reported Event|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
449568|NCT00871234|B1|Baseline|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
449569|NCT00871234|P1|Participant Flow|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
449570|NCT00871234|O1|Outcome|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
449571|NCT00871234|E1|Reported Event|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
449572|NCT00871169|B1|Baseline|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
449992|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
449573|NCT00871169|P1|Participant Flow|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
449574|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
449575|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
449576|NCT00871169|E1|Reported Event|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
449577|NCT00871143|B3|Baseline|Total|Total of all reporting groups
449578|NCT00871143|B2|Baseline|Non Specific CBT|Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
449579|NCT00871143|B1|Baseline|CBT Specific for BDD|This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
449580|NCT00871143|P2|Participant Flow|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits of anxiety management were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449581|NCT00871143|P1|Participant Flow|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449582|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449583|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449584|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449585|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449586|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449587|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449588|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449589|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449590|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449591|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449592|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449593|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449594|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449595|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449596|NCT00871143|E2|Reported Event|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
449597|NCT00871143|E1|Reported Event|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
449598|NCT00871117|B3|Baseline|Total|Total of all reporting groups
449599|NCT00871117|B2|Baseline|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449600|NCT00871117|B1|Baseline|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449601|NCT00871117|P2|Participant Flow|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449602|NCT00871117|P1|Participant Flow|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449603|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449604|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449605|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449608|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449609|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449610|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449611|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449612|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449613|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449614|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449615|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449616|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449617|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449618|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449619|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449620|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449621|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449622|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449623|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449624|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449625|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449626|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449627|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449628|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
449702|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
449629|NCT00871117|E2|Reported Event|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
449630|NCT00871117|E1|Reported Event|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm, and one dose of Varivax subcutaneously in the deltoid region of the right lower arm.
449631|NCT00871000|B3|Baseline|Total|Total of all reporting groups
449632|NCT00871000|B2|Baseline|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449633|NCT00871000|B1|Baseline|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449634|NCT00871000|P2|Participant Flow|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449635|NCT00871000|P1|Participant Flow|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449636|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449637|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449638|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449639|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449640|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449641|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449642|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449703|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
457214|NCT00852917|P2|Participant Flow|2: Tramadol Once A Day 200mg|
449643|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449644|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449645|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449646|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449647|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449648|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449649|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449650|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449651|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449652|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449653|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449654|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449704|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449705|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449655|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449656|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449657|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449658|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449659|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449660|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449661|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449662|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449663|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449664|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449665|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449666|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449706|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449707|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449667|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449668|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449669|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449670|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449671|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449672|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449673|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449674|NCT00871000|E2|Reported Event|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449675|NCT00871000|E1|Reported Event|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
449676|NCT00870896|B1|Baseline|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
449677|NCT00870896|P1|Participant Flow|Group 1|Capsaicin Inhalation challenge (CIH): Each solution of capsaicin administered to a subject will be quantified by HPLC. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two or more coughs (C2) and five or more coughs (C5) are reached. The different concentrations are delivered at 2 minute intervals. CIH is administered at baseline one and 3 months following treatment with Spiriva
449678|NCT00870896|O1|Outcome|Change in FEV1/FVC|We measured the change in FEV1/FVC ratio before and after treatment with Spiriva. Change in ratio reflects the percentage value at 30 days minus the percentage value at baseline
449708|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449679|NCT00870896|O1|Outcome|Spirometry|We measured the change in FEV1 (in liters) at baseline and following 30 days of treatment with Spiriva.Spirometry will be performed with a KoKO Spirometer, which uses a pneumotachograph to provide Flow/Volume Loops and Volume/Time graphics and multiple incentive graphics for patient coaching. Spirometry will be performed at baseline and at 4 weeks. Normal values will be those of Hankinson, et al (Am J Respir Crit Care Med 159:179-187). Spirometry will also be performed after each dose of inhaled capsaicin. If there is a drop of 20% or more in FEV1 at any time after inhalation of capsaicin, the protocol will be ended at that point.
449680|NCT00870896|O1|Outcome|Group 1|Capsaicin Inhalation Challenge Testing (CICT) will follow the protocol of Dicpinigaitis et al (Chest 2003; 123:685-8). CICT will be performed at baseline before beginning treatment with tiotropium and at 4 weeks after initiation of treatment. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until five or more coughs (C5) are reached. We measured the change in the number of coughs at baseline and following 30 days of treatment with spiriva
449681|NCT00870896|E1|Reported Event|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
449682|NCT00870740|B7|Baseline|Total|Total of all reporting groups
449683|NCT00870740|B6|Baseline|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449684|NCT00870740|B5|Baseline|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449685|NCT00870740|B4|Baseline|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449686|NCT00870740|B3|Baseline|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449687|NCT00870740|B2|Baseline|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449688|NCT00870740|B1|Baseline|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449689|NCT00870740|P6|Participant Flow|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449690|NCT00870740|P5|Participant Flow|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449691|NCT00870740|P4|Participant Flow|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449692|NCT00870740|P3|Participant Flow|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449693|NCT00870740|P2|Participant Flow|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449694|NCT00870740|P1|Participant Flow|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449695|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449696|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449697|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449698|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449699|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449700|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449701|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
449709|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449711|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449712|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449713|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449714|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449715|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449716|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449717|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449718|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449719|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449720|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449721|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449722|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449723|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449724|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449725|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449726|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449727|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449728|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449729|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449730|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449731|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449732|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449733|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449734|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
449735|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
449736|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
449737|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
449738|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
449739|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
449740|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449741|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449742|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449743|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449744|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449745|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449746|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
449747|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
449748|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
449749|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449750|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449751|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449752|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449753|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449754|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449755|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449756|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449757|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449758|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449759|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449760|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449761|NCT00870740|E6|Reported Event|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
449762|NCT00870740|E5|Reported Event|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
449763|NCT00870740|E4|Reported Event|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
449764|NCT00870740|E3|Reported Event|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
449765|NCT00870740|E2|Reported Event|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
449766|NCT00870740|E1|Reported Event|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
449767|NCT00870688|B1|Baseline|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
449768|NCT00870688|P1|Participant Flow|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
449769|NCT00870688|O1|Outcome|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
449770|NCT00870584|B3|Baseline|Total|Total of all reporting groups
449771|NCT00870584|B2|Baseline|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
449772|NCT00870584|B1|Baseline|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
449774|NCT00870584|P1|Participant Flow|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
449775|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
449776|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
449777|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
449778|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
449779|NCT00870584|E2|Reported Event|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
449780|NCT00870584|E1|Reported Event|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
449781|NCT00870545|B1|Baseline|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
449782|NCT00870545|P1|Participant Flow|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
449783|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
449784|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
449785|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
449786|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
449787|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
449808|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449833|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449788|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
449789|NCT00870545|E1|Reported Event|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
449790|NCT00870467|B3|Baseline|Total|Total of all reporting groups
449791|NCT00870467|B2|Baseline|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449792|NCT00870467|B1|Baseline|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449793|NCT00870467|P6|Participant Flow|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449794|NCT00870467|P5|Participant Flow|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449795|NCT00870467|P4|Participant Flow|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449796|NCT00870467|P3|Participant Flow|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449797|NCT00870467|P2|Participant Flow|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449798|NCT00870467|P1|Participant Flow|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449799|NCT00870467|O1|Outcome|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
449800|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449801|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449802|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449803|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449804|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449805|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449806|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449807|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449831|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
457215|NCT00852917|P1|Participant Flow|1: Tramadol Once A Day 100mg|
449809|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449810|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449811|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449812|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449813|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449814|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449815|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449816|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449817|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449818|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449819|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449820|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449821|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449822|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
449823|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449824|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449825|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449826|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449827|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449828|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449829|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449830|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449993|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
449834|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449835|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449836|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449837|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449838|NCT00870467|E3|Reported Event|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
449839|NCT00870467|E2|Reported Event|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449840|NCT00870467|E1|Reported Event|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
449841|NCT00870363|B5|Baseline|Total|Total of all reporting groups
449842|NCT00870363|B4|Baseline|HIV Negative Controls Not on ART|HIV-negative
449843|NCT00870363|B3|Baseline|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449844|NCT00870363|B2|Baseline|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449845|NCT00870363|B1|Baseline|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449846|NCT00870363|P4|Participant Flow|HIV Negative Controls Not on ART|HIV-negative
449847|NCT00870363|P3|Participant Flow|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449848|NCT00870363|P2|Participant Flow|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449849|NCT00870363|P1|Participant Flow|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449850|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
449851|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449852|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449853|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449854|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
449898|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449899|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449855|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449856|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449857|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449858|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
449859|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449860|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449861|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449862|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
449863|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449864|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449865|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449866|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
449867|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449868|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449869|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449870|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
449871|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449900|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
457216|NCT00852917|O4|Outcome|4: Placebo|
449872|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449873|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449874|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
449875|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449876|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449877|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449878|NCT00870363|E4|Reported Event|HIV Negative Controls Not on ART|HIV-negative
449879|NCT00870363|E3|Reported Event|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449880|NCT00870363|E2|Reported Event|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449881|NCT00870363|E1|Reported Event|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
449882|NCT00870194|B3|Baseline|Total|Total of all reporting groups
449883|NCT00870194|B2|Baseline|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449884|NCT00870194|B1|Baseline|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449885|NCT00870194|P2|Participant Flow|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449886|NCT00870194|P1|Participant Flow|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449887|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449888|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449889|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449890|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449891|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449892|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449893|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449894|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449895|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449896|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449897|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449901|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449902|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449903|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449904|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449905|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449906|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449907|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449908|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449909|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449910|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449911|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449912|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449913|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449914|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449915|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449916|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449917|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449918|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449919|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449920|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449921|NCT00870194|E2|Reported Event|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
449922|NCT00870194|E1|Reported Event|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
449923|NCT00870103|B1|Baseline|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
449924|NCT00870103|P1|Participant Flow|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
449925|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
449926|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
449927|NCT00870103|E1|Reported Event|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
449928|NCT00869999|B1|Baseline|Treatment Arm|All patients received treatment with everolimus-rituximab on this single am study
449929|NCT00869999|P1|Participant Flow|Everolimus-Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
449930|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
449931|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
449932|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
449988|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
449933|NCT00869999|E1|Reported Event|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
449934|NCT00869960|B1|Baseline|Combination Antiretroviral Therapy|Single dose administration of tenofovir, emtricitabine, atazanavir and ritonavir to healthy women
449935|NCT00869960|P1|Participant Flow|Antiretroviral Therapy|Healthy volunteers
449936|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449937|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449938|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449939|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449940|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449941|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449942|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449943|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
449944|NCT00869960|E1|Reported Event|Antiretroviral Therapy|Healthy volunteers
449945|NCT00869947|B3|Baseline|Total|Total of all reporting groups
449946|NCT00869947|B2|Baseline|Non-amputee|Non-amputees
449947|NCT00869947|B1|Baseline|Prosthesis|Subjects with transtibial amputation using a passive ankle-foot prosthesis
449948|NCT00869947|P2|Participant Flow|Non-amputees|Non-amputees
449949|NCT00869947|P1|Participant Flow|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
449950|NCT00869947|O3|Outcome|Non-Amputees|
449951|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
449952|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
449953|NCT00869947|O3|Outcome|Non-amputees|
449954|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
449955|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
449956|NCT00869947|O3|Outcome|Non-amputees|
449957|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
449958|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
449959|NCT00869947|E2|Reported Event|Non-amputees|Non-amputees
449960|NCT00869947|E1|Reported Event|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
449961|NCT00869791|B1|Baseline|All Study Participants|Participants who were randomized to receive either IPX066 or IR CD-LD
449962|NCT00869791|P2|Participant Flow|IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days)|In this arm there were 2 treatment periods of one week each. During period 1, 13 subjects received 7 days of IR CD-LD first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 13 subjects received IPX066 for 7 days.
449963|NCT00869791|P1|Participant Flow|IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days)|In this arm there were 2 treatment periods of one week each. During period 1, 14 subjects received 7 days of IPX066 first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 14 subjects received IR CD-LD for 7 days.
449964|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
449965|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
449966|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
449967|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
449968|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
449969|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
449970|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
449971|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
449972|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
449973|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
449974|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
449975|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
449976|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
449977|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
449978|NCT00869791|E2|Reported Event|CD-LD IR|All participants who received IR CD-LD in either study period
449979|NCT00869791|E1|Reported Event|IPX066|All participants who received IPX066 in either study period
449980|NCT00869778|B4|Baseline|Total|Total of all reporting groups
449981|NCT00869778|B3|Baseline|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
449982|NCT00869778|B2|Baseline|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
449983|NCT00869778|B1|Baseline|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
449984|NCT00869778|P3|Participant Flow|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
449985|NCT00869778|P2|Participant Flow|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
449986|NCT00869778|P1|Participant Flow|εPA-44 900μg|Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
449987|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
457217|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
449994|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
449995|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
449996|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
449997|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
449998|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
449999|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
450000|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
450001|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
450002|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
450003|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
450004|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
450005|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
450006|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
450007|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
450008|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
450009|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
450010|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
450011|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
450012|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
450013|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
450014|NCT00869778|O3|Outcome|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
450015|NCT00869778|O2|Outcome|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
450016|NCT00869778|O1|Outcome|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
450017|NCT00869778|E3|Reported Event|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
450018|NCT00869778|E2|Reported Event|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
450019|NCT00869778|E1|Reported Event|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28."
450020|NCT00869622|B3|Baseline|Total|Total of all reporting groups
450021|NCT00869622|B2|Baseline|Placebo Sugar Pill|Placebo participants received calcium and vitamin D supplementation in addition to a placebo tablet identical to risedronate tablet weekly
450022|NCT00869622|B1|Baseline|Risedronate|Active drug participants received calcium and vitamin D supplementation in addition to 35 mgs of risedronate tablet weekly
450023|NCT00869622|P2|Participant Flow|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
450024|NCT00869622|P1|Participant Flow|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
450025|NCT00869622|O2|Outcome|Placebo + Calcium and Vitamin D|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + Calcium and Vitamin D: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
450026|NCT00869622|O1|Outcome|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
450027|NCT00869622|O2|Outcome|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
450028|NCT00869622|O1|Outcome|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
450029|NCT00869622|E2|Reported Event|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
450030|NCT00869622|E1|Reported Event|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
450031|NCT00869609|B3|Baseline|Total|Total of all reporting groups
450032|NCT00869609|B2|Baseline|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450073|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450074|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450033|NCT00869609|B1|Baseline|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450034|NCT00869609|P2|Participant Flow|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450035|NCT00869609|P1|Participant Flow|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450036|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450037|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450038|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450039|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450040|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450041|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450051|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450151|NCT00869349|B3|Baseline|Total|Total of all reporting groups
450042|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450043|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450044|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450045|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450046|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450047|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450048|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450049|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450050|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450071|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450072|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450052|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450053|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450054|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450055|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450056|NCT00869609|E2|Reported Event|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450057|NCT00869609|E1|Reported Event|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
450058|NCT00869557|B3|Baseline|Total|Total of all reporting groups
450059|NCT00869557|B2|Baseline|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450060|NCT00869557|B1|Baseline|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450061|NCT00869557|P2|Participant Flow|Atripla|Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450062|NCT00869557|P1|Participant Flow|Stribild|Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS) were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450063|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450064|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450065|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450066|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450067|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450068|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450069|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
450070|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
450759|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450075|NCT00869557|E3|Reported Event|All Stribild|The All Stribild safety analysis set included all participants who received at least 1 dose of Stribild in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind Stribild group while they received double-blind Stribild during the randomized phase and open-label Stribild during the extension phase; adverse events collected from the open-label Stribild extension phase only from the participants who were initially randomized to the Atripla group during the randomized phase.
450076|NCT00869557|E2|Reported Event|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
450077|NCT00869557|E1|Reported Event|Stribild|Stribild and placebo to match Atripla were administered during the double-blind phase.
450078|NCT00869518|B3|Baseline|Total|Total of all reporting groups
450079|NCT00869518|B2|Baseline|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450080|NCT00869518|B1|Baseline|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450081|NCT00869518|P2|Participant Flow|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450082|NCT00869518|P1|Participant Flow|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450083|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450084|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450085|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450086|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450087|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450088|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450089|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450090|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450091|NCT00869518|E2|Reported Event|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450092|NCT00869518|E1|Reported Event|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
450093|NCT00869414|B1|Baseline|All Study Participants|Participants were randomized to receive one of the three interventions: Insulin glargine only in the morning, Insulin glargine only in the evening, or a split dose of insulin glargine (half the dose in the morning and the other half in the evening).
450094|NCT00869414|P3|Participant Flow|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening~split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
450095|NCT00869414|P2|Participant Flow|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine~Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
450096|NCT00869414|P1|Participant Flow|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine~Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
450097|NCT00869414|O3|Outcome|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening~split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
450098|NCT00869414|O2|Outcome|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine~Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
450099|NCT00869414|O1|Outcome|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine~Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
450178|NCT00869167|B1|Baseline|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450100|NCT00869414|O3|Outcome|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening~split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
450101|NCT00869414|O2|Outcome|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine~Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
450102|NCT00869414|O1|Outcome|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine~Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
450103|NCT00869414|E3|Reported Event|Split Dose Insulin Glargine|"Split dose administration of insulin glargine, half dose in morning, half dose in evening~split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening"
450104|NCT00869414|E2|Reported Event|Insulin Glargine Only at Evening|"Evening only administration of insulin glargine~Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning."
450105|NCT00869414|E1|Reported Event|Insulin Glargine Only in Morning|"Morning only administration of insulin glargine~Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night."
450106|NCT00869401|B4|Baseline|Total|Total of all reporting groups
450107|NCT00869401|B3|Baseline|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
450108|NCT00869401|B2|Baseline|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450109|NCT00869401|B1|Baseline|Phase I|All patients included in the Phase I portion of the study were published together for this results portion.
450110|NCT00869401|P5|Participant Flow|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
450111|NCT00869401|P4|Participant Flow|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450112|NCT00869401|P3|Participant Flow|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450113|NCT00869401|P2|Participant Flow|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
450114|NCT00869401|P1|Participant Flow|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
450115|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
450116|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450117|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
450118|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450152|NCT00869349|B2|Baseline|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
450119|NCT00869401|O3|Outcome|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450120|NCT00869401|O2|Outcome|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
450121|NCT00869401|O1|Outcome|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
450122|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
450123|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450124|NCT00869401|E5|Reported Event|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
450125|NCT00869401|E4|Reported Event|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450126|NCT00869401|E3|Reported Event|Dose Level 1 Phase1|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
450127|NCT00869401|E2|Reported Event|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib100 mg/day until progression.
450128|NCT00869401|E1|Reported Event|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
450129|NCT00869375|B3|Baseline|Total|Total of all reporting groups
450130|NCT00869375|B2|Baseline|ANGIOJET GROUP|3 patients were randomized in this group
450131|NCT00869375|B1|Baseline|CLEARWAY GROUP|3 patients were randomized in this group.
450132|NCT00869375|P2|Participant Flow|ANGIOJET GROUP|3 patients were randomized in this group
450133|NCT00869375|P1|Participant Flow|CLEARWAY GROUP|3 patients were randomized in this group.
450134|NCT00869375|O2|Outcome|ANGIOJET GROUP|3 patients were randomized in this group
450135|NCT00869375|O1|Outcome|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
450136|NCT00869375|O2|Outcome|ANGIOJET GROUP|No patients had distal embolization
450137|NCT00869375|O1|Outcome|CLEARWAY GROUP|No patients had distal embolization
450138|NCT00869375|E2|Reported Event|ANGIOJET GROUP|3 patients were randomized in this group
450139|NCT00869375|E1|Reported Event|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
450140|NCT00869362|B3|Baseline|Total|Total of all reporting groups
450141|NCT00869362|B2|Baseline|Control|Patients receive usual care for diabetes
450142|NCT00869362|B1|Baseline|Diabetes Management Team|Evaluation and management by diabetes management team
450143|NCT00869362|P2|Participant Flow|Control|Patients receive usual care for diabetes
450144|NCT00869362|P1|Participant Flow|Diabetes Management Team|Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills.
450145|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
450146|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team
450147|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
450148|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team (physician, nurse practitioner CDE) with physician-initiation and titration of diabetes medication and nurse CDE education on Diabetes Survival Skills.
450149|NCT00869362|E2|Reported Event|Control|Patients receive usual care for diabetes
450150|NCT00869362|E1|Reported Event|Diabetes Management Team|Evaluation and management by diabetes management team
450153|NCT00869349|B1|Baseline|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
450154|NCT00869349|P2|Participant Flow|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
450155|NCT00869349|P1|Participant Flow|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
450156|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
450157|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
450158|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
450159|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
450160|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
450161|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
450162|NCT00869349|E2|Reported Event|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
450163|NCT00869349|E1|Reported Event|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
450174|NCT00869258|O1|Outcome|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
450175|NCT00869258|E1|Reported Event|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
450176|NCT00869167|B3|Baseline|Total|Total of all reporting groups
450177|NCT00869167|B2|Baseline|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450164|NCT00869323|B1|Baseline|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450165|NCT00869323|P1|Participant Flow|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450166|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450167|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450168|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450169|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450170|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450171|NCT00869323|E1|Reported Event|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
450172|NCT00869258|B1|Baseline|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
450173|NCT00869258|P1|Participant Flow|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
450179|NCT00869167|P2|Participant Flow|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450180|NCT00869167|P1|Participant Flow|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450181|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
450182|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
450183|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450184|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450185|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450186|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450187|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450188|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450189|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450190|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450191|NCT00869167|E2|Reported Event|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450192|NCT00869167|E1|Reported Event|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
450193|NCT00869141|B3|Baseline|Total|Total of all reporting groups
450194|NCT00869141|B2|Baseline|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450195|NCT00869141|B1|Baseline|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450196|NCT00869141|P2|Participant Flow|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450197|NCT00869141|P1|Participant Flow|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450198|NCT00869141|O2|Outcome|Non-hypertensive Phase Group|Eyes that did not develop hypertensive phase after Ahmed valve implantation
450199|NCT00869141|O1|Outcome|Hypertensive Phase Group|Eyes that developed hypertensive phase after Ahmed valve implantation
450200|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450201|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450202|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450203|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450204|NCT00869141|E2|Reported Event|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450205|NCT00869141|E1|Reported Event|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
450206|NCT00869128|B1|Baseline|Entire Study Population|Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.
450207|NCT00869128|P2|Participant Flow|Circadin First|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.
450208|NCT00869128|P1|Participant Flow|Placebo First|Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
450209|NCT00869128|O2|Outcome|Circadin|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg
450210|NCT00869128|O1|Outcome|Placebo|Subjects were treated for 3 weeks with 1 tablet per night of Placebo
450211|NCT00869089|B1|Baseline|CC-10004|CC-10004 Treatment
450212|NCT00869089|P1|Participant Flow|CC-10004|"CC-10004 treatment:~30mg,oral medication, BID, for 24 weeks (60mg total DAILY)"
450213|NCT00869089|O1|Outcome|CC-10004|CC-10004 treatment
450214|NCT00869089|E1|Reported Event|CC-10004|CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
450215|NCT00869050|B1|Baseline|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
450216|NCT00869050|P1|Participant Flow|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
450217|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
450218|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
450219|NCT00869050|E1|Reported Event|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
450220|NCT00868998|B1|Baseline|Treatment|Gemcitabine, Docetaxel, and Capecitabine
450221|NCT00868998|P1|Participant Flow|Treatment|Gemcitabine, Docetaxel, and Capecitabine
450222|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
450223|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
450224|NCT00868998|E1|Reported Event|Treatment|Gemcitabine, Docetaxel, and Capecitabine
450225|NCT00868959|B1|Baseline|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
450226|NCT00868959|P1|Participant Flow|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
450227|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
450228|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
450229|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
450230|NCT00868959|E1|Reported Event|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
450231|NCT00868790|B1|Baseline|All Randomized Participants|All randomized participants who took at least one dose of study treatment
450232|NCT00868790|P14|Participant Flow|METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)|Domiciled participants received oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
450259|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
450260|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
450233|NCT00868790|P13|Participant Flow|PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)|Domiciled participants received oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
450234|NCT00868790|P12|Participant Flow|MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
450235|NCT00868790|P11|Participant Flow|MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
450236|NCT00868790|P10|Participant Flow|MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
450237|NCT00868790|P9|Participant Flow|PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
450238|NCT00868790|P8|Participant Flow|MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
450239|NCT00868790|P7|Participant Flow|MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
450240|NCT00868790|P6|Participant Flow|MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
450241|NCT00868790|P5|Participant Flow|PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
450242|NCT00868790|P4|Participant Flow|MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
450243|NCT00868790|P3|Participant Flow|MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
450244|NCT00868790|P2|Participant Flow|MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
450245|NCT00868790|P1|Participant Flow|PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
450246|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
450247|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
450248|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
450249|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
450250|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
450251|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
450252|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
450253|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
450254|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
450255|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
450256|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
450257|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
450258|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
457218|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
450261|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
450262|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
450263|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
450264|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
450265|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
450266|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
450267|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
450268|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
450269|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
450270|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
450271|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
450272|NCT00868790|O4|Outcome|MK-3577 BID|Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
450273|NCT00868790|O3|Outcome|MK-3577 PM|Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
450274|NCT00868790|O2|Outcome|MK-3577 AM|Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
450275|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
450276|NCT00868790|E5|Reported Event|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
450277|NCT00868790|E4|Reported Event|MK-3577 BID|Participants received 25 mg MK-3577 orally BID for 4 weeks.
450278|NCT00868790|E3|Reported Event|MK-3577 PM|Participants received 6 mg MK-3577 orally QD in the PM for 4 weeks.
450279|NCT00868790|E2|Reported Event|MK-3577 AM|Participants received 10 mg MK-3577 orally QD in the AM for 4 weeks.
450280|NCT00868790|E1|Reported Event|Placebo|Participants received a placebo tablet matching the respective MK-3577 dose (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
450281|NCT00868751|B1|Baseline|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450282|NCT00868751|P1|Participant Flow|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450283|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450284|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450285|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450286|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450360|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
457219|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
450287|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450288|NCT00868751|E1|Reported Event|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
450289|NCT00868712|B4|Baseline|Total|Total of all reporting groups
450290|NCT00868712|B3|Baseline|3 - Warfarin Use Chronic|Warfarin use >24 months
450291|NCT00868712|B2|Baseline|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
450292|NCT00868712|B1|Baseline|Warfarin Use Short Duration|Warfarin use for less than 6 months
450293|NCT00868712|P3|Participant Flow|3 - Warfarin Use Chronic|Warfarin use >24 months
450294|NCT00868712|P2|Participant Flow|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
450295|NCT00868712|P1|Participant Flow|Warfarin Use Short Duration|Warfarin use for less than 6 months
450296|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
450297|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
450298|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
450299|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
450300|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
450301|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
450302|NCT00868712|E3|Reported Event|3 - Warfarin Use Chronic|Warfarin use >24 months
450303|NCT00868712|E2|Reported Event|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
450304|NCT00868712|E1|Reported Event|Warfarin Use Short Duration|Warfarin use for less than 6 months
450305|NCT00868699|B4|Baseline|Total|Total of all reporting groups
450306|NCT00868699|B3|Baseline|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
450307|NCT00868699|B2|Baseline|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
450308|NCT00868699|B1|Baseline|Placebo|Placebo : Placebo Comparator
450309|NCT00868699|P3|Participant Flow|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
450310|NCT00868699|P2|Participant Flow|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
450311|NCT00868699|P1|Participant Flow|Placebo|Placebo : Placebo Comparator
450312|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
450313|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
450314|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
450315|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
450316|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
450317|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
450318|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
450319|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
450320|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
450321|NCT00868699|E3|Reported Event|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
450322|NCT00868699|E2|Reported Event|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
450323|NCT00868699|E1|Reported Event|Placebo|Placebo : Placebo Comparator
450324|NCT00868608|B4|Baseline|Total|Total of all reporting groups
450325|NCT00868608|B3|Baseline|Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450326|NCT00868608|B2|Baseline|Inotuzumab Ozogamicin - NHL Type (Marginal Zone)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450327|NCT00868608|B1|Baseline|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450328|NCT00868608|P3|Participant Flow|Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450329|NCT00868608|P2|Participant Flow|Inotuzumab Ozogamicin - NHL Type (Marginal Zone)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450330|NCT00868608|P1|Participant Flow|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent Non-Hodgkin’s Lymphoma (NHL) defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 percent [%] of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450331|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450332|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450333|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450334|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450335|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450336|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450760|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450337|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450338|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450339|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450340|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450341|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450342|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450343|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450344|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450345|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450346|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles (in participants who achieved a CR). After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450392|NCT00868517|E1|Reported Event|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
457220|NCT00852917|O4|Outcome|4: Placebo|
450347|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450348|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450349|NCT00868608|O1|Outcome|Inotuzumab Ozogamicin - Total (All NHL Types)|Participants who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone or small lymphocytic lymphoma) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450350|NCT00868608|E3|Reported Event|Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as small lymphocytic (a less common form of indolent B-cell lymphomas, comprising approximately 5% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450351|NCT00868608|E2|Reported Event|Inotuzumab Ozogamicin - NHL Type (Marginal Zone)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as marginal zone (a less common form of indolent B-cell lymphomas, comprising approximately 6% of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450352|NCT00868608|E1|Reported Event|Inotuzumab Ozogamicin - NHL Type (Follicular)|Participants who have been previously diagnosed with CD22-positive, indolent NHL defined as follicular (the most common of the indolent B-cell lymphomas, comprising approximately 22 % of all B-cell lymphomas) received inotozumab ozogamicin, administered at 1.8 mg/m^2 IV on Day 1 of each 28-day cycle for at least 4 cycles and up to a maximum of 8 cycles. After Cycle 1, the dose and/or the frequency may have been adjusted, based on toxicities. Participants who may have derived benefit from additional treatment may have continued to receive additional cycles of test article, up to a maximum of 2 additional cycles after achievement of a CR or up to a maximum of 8 cycles, whichever occurred first.
450353|NCT00868530|B1|Baseline|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450354|NCT00868530|P1|Participant Flow|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450355|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450356|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450357|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450358|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450359|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450393|NCT00868452|B3|Baseline|Total|Total of all reporting groups
450508|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450361|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450362|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450363|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450364|NCT00868530|E1|Reported Event|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
450365|NCT00868517|B4|Baseline|Total|Total of all reporting groups
450366|NCT00868517|B3|Baseline|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450367|NCT00868517|B2|Baseline|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450368|NCT00868517|B1|Baseline|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
450369|NCT00868517|P3|Participant Flow|Wait-List Control Group|Served as wait-list control group. Did not receive any type of group ear acupuncture intervention--served as strict control and received conventional care only. Eligible to receive true group auricular acupuncture once study period was completed.
450370|NCT00868517|P2|Participant Flow|Sham Group Auricular Acupuncture|Received sham group auricular acupuncture.
450371|NCT00868517|P1|Participant Flow|True Group Auricular Acupuncture|Received true group auricular acupuncture.
450372|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450373|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450374|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
450375|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450376|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450377|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
450378|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450379|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450380|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
450381|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450382|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450383|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
450384|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450385|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450386|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
450387|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450388|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450389|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
450390|NCT00868517|E3|Reported Event|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
450391|NCT00868517|E2|Reported Event|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
450394|NCT00868452|B2|Baseline|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
450395|NCT00868452|B1|Baseline|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
450396|NCT00868452|P2|Participant Flow|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
450397|NCT00868452|P1|Participant Flow|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
450398|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
450399|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
450400|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
450401|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
450402|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
450403|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
450404|NCT00868452|E2|Reported Event|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
450405|NCT00868452|E1|Reported Event|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
450406|NCT00868439|B3|Baseline|Total|Total of all reporting groups
450407|NCT00868439|B2|Baseline|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450408|NCT00868439|B1|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450409|NCT00868439|P2|Participant Flow|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450410|NCT00868439|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450411|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450412|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450413|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450414|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450433|NCT00868374|E1|Reported Event|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450434|NCT00868348|B3|Baseline|Total|Total of all reporting groups
450509|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450415|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450416|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450417|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450418|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450419|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450420|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450421|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450422|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450423|NCT00868439|E2|Reported Event|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450424|NCT00868439|E1|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
450425|NCT00868374|B3|Baseline|Total|Total of all reporting groups
450426|NCT00868374|B2|Baseline|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450427|NCT00868374|B1|Baseline|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450428|NCT00868374|P2|Participant Flow|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450429|NCT00868374|P1|Participant Flow|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450430|NCT00868374|O2|Outcome|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450431|NCT00868374|O1|Outcome|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450432|NCT00868374|E2|Reported Event|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
450498|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450435|NCT00868348|B2|Baseline|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450436|NCT00868348|B1|Baseline|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450437|NCT00868348|P2|Participant Flow|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450438|NCT00868348|P1|Participant Flow|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450439|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450440|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450441|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450442|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450443|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450444|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450445|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450446|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450447|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450448|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450449|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450450|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450451|NCT00868348|E2|Reported Event|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
450452|NCT00868348|E1|Reported Event|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
450453|NCT00868309|B3|Baseline|Total|Total of all reporting groups
450454|NCT00868309|B2|Baseline|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
450455|NCT00868309|B1|Baseline|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
450456|NCT00868309|P2|Participant Flow|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
450457|NCT00868309|P1|Participant Flow|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
450458|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
450459|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
450460|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
450461|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
450462|NCT00868309|E2|Reported Event|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
450463|NCT00868309|E1|Reported Event|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
450464|NCT00868296|B3|Baseline|Total|Total of all reporting groups
450499|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450500|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450501|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450502|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450503|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450504|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450465|NCT00868296|B2|Baseline|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
450466|NCT00868296|B1|Baseline|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
450467|NCT00868296|P2|Participant Flow|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
450468|NCT00868296|P1|Participant Flow|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
450469|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
450470|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
450471|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
450472|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
450473|NCT00868296|E2|Reported Event|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
450474|NCT00868296|E1|Reported Event|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
450475|NCT00868231|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
450505|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450506|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450476|NCT00868231|P6|Participant Flow|Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days."
450477|NCT00868231|P5|Participant Flow|Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
450478|NCT00868231|P4|Participant Flow|Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
450479|NCT00868231|P3|Participant Flow|Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
450480|NCT00868231|P2|Participant Flow|Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
450481|NCT00868231|P1|Participant Flow|Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
450482|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450483|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450484|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450485|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450486|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450487|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450488|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450489|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450490|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450491|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450492|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450493|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450494|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450495|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450496|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450497|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450511|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450512|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450513|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450514|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450515|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
450516|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450517|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450518|NCT00868231|E3|Reported Event|Placebo|Placebo via inhalation
450519|NCT00868231|E2|Reported Event|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
450520|NCT00868231|E1|Reported Event|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
450521|NCT00868218|B5|Baseline|Total|Total of all reporting groups
450522|NCT00868218|B4|Baseline|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450523|NCT00868218|B3|Baseline|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450524|NCT00868218|B2|Baseline|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450525|NCT00868218|B1|Baseline|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450526|NCT00868218|P4|Participant Flow|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450527|NCT00868218|P3|Participant Flow|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450528|NCT00868218|P2|Participant Flow|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450529|NCT00868218|P1|Participant Flow|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
450530|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
450531|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
450532|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
450533|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
450534|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
450535|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
450536|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
450537|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
450538|NCT00868218|O4|Outcome|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450539|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450540|NCT00868218|O2|Outcome|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450541|NCT00868218|O1|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
450542|NCT00868218|E4|Reported Event|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450543|NCT00868218|E3|Reported Event|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450544|NCT00868218|E2|Reported Event|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450545|NCT00868218|E1|Reported Event|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
450546|NCT00868192|B1|Baseline|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450547|NCT00868192|P1|Participant Flow|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450548|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450549|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450550|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450551|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450552|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450553|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450554|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450555|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450556|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450557|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450558|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450559|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450560|NCT00868192|E1|Reported Event|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
450561|NCT00868140|B3|Baseline|Total|Total of all reporting groups
450562|NCT00868140|B2|Baseline|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
450563|NCT00868140|B1|Baseline|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
450564|NCT00868140|P2|Participant Flow|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
450565|NCT00868140|P1|Participant Flow|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
450566|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
450567|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
450568|NCT00868140|O2|Outcome|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
450569|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
450570|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
450571|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
450572|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
450573|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
450574|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
450575|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
450576|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
450577|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
450578|NCT00868140|E2|Reported Event|2/Placebo|"Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months~Placebo: placebo daily"
450579|NCT00868140|E1|Reported Event|1/Pioglitazone|"Pioglitazone in pill form at 45mg twice per day for 6 months~pioglitazone: pioglitazone 45 mg"
450580|NCT00868101|B3|Baseline|Total|Total of all reporting groups
450581|NCT00868101|B2|Baseline|Control|Children who did not receive the preconditioning stimulus
450582|NCT00868101|B1|Baseline|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
450583|NCT00868101|P2|Participant Flow|Control|Children who did not receive the preconditioning stimulus
450584|NCT00868101|P1|Participant Flow|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
450585|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
450586|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
450587|NCT00868101|O2|Outcome|Control|Children that don´t received the preconditioning stimmulus
450588|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus
450589|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
450590|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
450591|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
450592|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
450593|NCT00868101|E2|Reported Event|Control|Children who did not receive the preconditioning stimulus
450594|NCT00868101|E1|Reported Event|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
450595|NCT00867659|B1|Baseline|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
450596|NCT00867659|P1|Participant Flow|Cetrotide Acetate|oocyte donors will receive 3 mg cetrotide acetate by a single injection on the day of oocyte retrieval. The incidence of OHSS will be assessed.
457221|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
450597|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
450598|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive a single injection of 3 mg cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
450599|NCT00867659|E1|Reported Event|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
450600|NCT00867568|B1|Baseline|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450601|NCT00867568|P1|Participant Flow|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450602|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450603|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450604|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450605|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450606|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450607|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450608|NCT00867568|E1|Reported Event|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
450609|NCT00867529|B1|Baseline|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450610|NCT00867529|P1|Participant Flow|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450611|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450612|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450613|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450614|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450615|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450616|NCT00867529|E1|Reported Event|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
450617|NCT00867503|B1|Baseline|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
450618|NCT00867503|P1|Participant Flow|Bendamustine|Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
450619|NCT00867503|O1|Outcome|Median Overall Survival in Days|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
450620|NCT00867503|O1|Outcome|Bendamustine Grade 4 Toxicity|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
450621|NCT00867503|O1|Outcome|Bendamustine Median Progression Free Surivial in Months|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
450622|NCT00867503|E1|Reported Event|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
450623|NCT00867490|B1|Baseline|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
450624|NCT00867490|P1|Participant Flow|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
450625|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
450626|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
450627|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
450628|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
450653|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
450654|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
450629|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
450630|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
450631|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
450632|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
450633|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
450634|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
450635|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
450636|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
450637|NCT00867490|E3|Reported Event|Phase 3 - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.
450638|NCT00867490|E2|Reported Event|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
450639|NCT00867490|E1|Reported Event|Phase 1 - Candesartan+HCTZ|4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide (HCTZ) 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.
450640|NCT00867451|B3|Baseline|Total|Total of all reporting groups
450641|NCT00867451|B2|Baseline|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
450642|NCT00867451|B1|Baseline|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
450643|NCT00867451|P2|Participant Flow|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
450644|NCT00867451|P1|Participant Flow|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
450645|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
450646|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
450647|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
450648|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
450649|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
450650|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
450651|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
450652|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
450754|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450655|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
450656|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
450657|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
450658|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
450659|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
450660|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
450661|NCT00867451|E2|Reported Event|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
450662|NCT00867451|E1|Reported Event|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
450663|NCT00867360|B3|Baseline|Total|Total of all reporting groups
450664|NCT00867360|B2|Baseline|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
450665|NCT00867360|B1|Baseline|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
450666|NCT00867360|P2|Participant Flow|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
450667|NCT00867360|P1|Participant Flow|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
450668|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
450669|NCT00867360|O1|Outcome|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
450670|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
450671|NCT00867360|O1|Outcome|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
450672|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
450673|NCT00867360|O1|Outcome|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
450674|NCT00867360|E2|Reported Event|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
450675|NCT00867360|E1|Reported Event|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
450676|NCT00867321|B4|Baseline|Total|Total of all reporting groups
450677|NCT00867321|B3|Baseline|All Phase I Patients|This includes all patients who participated in the phase I dose escalation portion of the trial.
450678|NCT00867321|B2|Baseline|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
450679|NCT00867321|B1|Baseline|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
450680|NCT00867321|P6|Participant Flow|Phase I: Dose Level -2|"Patients receive: > > Oral 200 mg BID Sorafenib days 1-28 >~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
450681|NCT00867321|P5|Participant Flow|Phase I: Dose Level -2a|"Patients receive: > > Oral 200 mg BID Sorafenib days 1-28 >~> 2.5 mg/kg Bevacizumab IV on days 1, 15"
450682|NCT00867321|P4|Participant Flow|Phase I: Dose Level -1|"Patients receive: > > Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days >~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
450683|NCT00867321|P3|Participant Flow|Phase I: Dose Level 0|"Patients receive: > > Oral 400 mg BID Sorafenib on days 1-28. >~> 1.25 mg/kg Bevacizumab IV on days 1, 15."
450684|NCT00867321|P2|Participant Flow|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
450685|NCT00867321|P1|Participant Flow|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
450686|NCT00867321|O2|Outcome|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
450687|NCT00867321|O1|Outcome|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
450688|NCT00867321|O2|Outcome|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
450689|NCT00867321|O1|Outcome|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
450690|NCT00867321|O2|Outcome|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
450691|NCT00867321|O1|Outcome|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
450692|NCT00867321|O4|Outcome|Phase I: Dose Level -2|"Patients receive:~>~> Oral 200 mg BID Sorafenib days 1-28~>~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
450693|NCT00867321|O3|Outcome|Phase I: Dose Level -2a (Maximum Tolerated Dose)|"Patients receive:~>~> Oral 200 mg BID Sorafenib days 1-28~>~> 2.5 mg/kg Bevacizumab IV on days 1, 15"
450694|NCT00867321|O2|Outcome|Phase I: Dose Level -1|"Patients receive:~>~> Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days~>~> 1.25 mg/kg Bevacizumab IV on days 1, 15"
450695|NCT00867321|O1|Outcome|Phase I: Dose Level 0|"Patients receive:~>~> Oral 400 mg BID Sorafenib on days 1-28.~>~> 1.25 mg/kg Bevacizumab IV on days 1, 15."
450696|NCT00867321|E6|Reported Event|Arm II (Phase II)|Patients receive oral sorafenib tosylate twice daily on days 1-28.
450697|NCT00867321|E5|Reported Event|Arm I (Phase II)|Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
450698|NCT00867321|E4|Reported Event|Phase I: Dose Level -2|"Patients receive:~Oral 200 mg BID Sorafenib days 1-28~1.25 mg/kg Bevacizumab IV on days 1, 15"
450699|NCT00867321|E3|Reported Event|Phase I: Dose Level -2a|"Patients receive:~Oral 200 mg BID Sorafenib days 1-28~2.5 mg/kg Bevacizumab IV on days 1, 15"
450700|NCT00867321|E2|Reported Event|Phase I: Dose Level -1|"Patients receive:~Oral 400 mg BID Sorafenib, 5 consecutive days out of each 7 days~1.25 mg/kg Bevacizumab IV on days 1, 15"
450701|NCT00867321|E1|Reported Event|Phase I: Dose Level 0|"Patients receive:~Oral 400 mg BID Sorafenib on days 1-28.~1.25 mg/kg Bevacizumab IV on days 1, 15"
450702|NCT00867217|B3|Baseline|Total|Total of all reporting groups
450703|NCT00867217|B2|Baseline|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
450704|NCT00867217|B1|Baseline|Placebo|Placebo (3 capsules of matching placebo weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
450705|NCT00867217|P2|Participant Flow|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
450706|NCT00867217|P1|Participant Flow|Placebo|Placebo (3 capsules of matching placebo given weekly) along with standard of care medication (Standard Dose Vitamin D3, 600 IU of vitamin D3 daily; letrozole, 2.5 mg daily) for 24 weeks.
450707|NCT00867217|O2|Outcome|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks
450708|NCT00867217|O1|Outcome|Placebo|Placebo (3 capsules of matching placebo) along with standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks
450709|NCT00867217|E2|Reported Event|Vitamin D|High Dose Vitamin D3 (3 capsules of 10,000 IU) capsules along with standard of care medication standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly
450710|NCT00867217|E1|Reported Event|Placebo|Placebo (3 capsules of matching placebo) along with standard of care medication (Standard Dose Vitamin D3; 600 IU of vitamin D3 daily) given weekly for 24 weeks
450711|NCT00867165|B3|Baseline|Total|Total of all reporting groups
450712|NCT00867165|B2|Baseline|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450713|NCT00867165|B1|Baseline|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450714|NCT00867165|P2|Participant Flow|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450715|NCT00867165|P1|Participant Flow|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450716|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450717|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450718|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450719|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450720|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450721|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450722|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450723|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450724|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450725|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450726|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450727|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450728|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450729|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450730|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450731|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450732|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450733|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450734|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450735|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450736|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450737|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450738|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450739|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450740|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450741|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450742|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450743|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450744|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450745|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450746|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450747|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450748|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450749|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450750|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450751|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450752|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450753|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
457222|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
450761|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450762|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450763|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450764|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450765|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450766|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450767|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450768|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450769|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450770|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450771|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450772|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450773|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450774|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450775|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450776|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450777|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450778|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450779|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450780|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450781|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450782|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450783|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450784|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450785|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450786|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450787|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450788|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450789|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450790|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450791|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450792|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450793|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450794|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450795|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450796|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450797|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450798|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450799|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450800|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450801|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450802|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450803|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450804|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450805|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450806|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450807|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450808|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450809|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450810|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450811|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450812|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450813|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450814|NCT00867165|E2|Reported Event|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
450815|NCT00867165|E1|Reported Event|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
450816|NCT00867139|B4|Baseline|Total|Total of all reporting groups
450817|NCT00867139|B3|Baseline|Open-Labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received open-label TCAD.
450818|NCT00867139|B2|Baseline|Neuraminidase Inhibitor Monotheraphy|Neuraminidase inhibitors include zanamivir and oseltamivir phosphate in this study.
450819|NCT00867139|B1|Baseline|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
450820|NCT00867139|P3|Participant Flow|Open-labeled TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
457223|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
450821|NCT00867139|P2|Participant Flow|Neuraminidase Inhibitor Monotherapy|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
450822|NCT00867139|P1|Participant Flow|TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
450823|NCT00867139|O3|Outcome|Open-lable TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450824|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450825|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450826|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450827|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450828|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receiveTCAD or neuraminidase inhibitor monotherapy.
450829|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450830|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450831|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450832|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450833|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450834|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450835|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450836|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450837|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450838|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450839|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450840|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450841|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450842|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450843|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450844|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450845|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450846|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450847|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450848|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450849|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
457224|NCT00852917|O4|Outcome|4: Placebo|
450850|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450851|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450852|NCT00867139|O1|Outcome|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
450853|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450854|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450855|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450856|NCT00867139|O3|Outcome|Open-labeled TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
450857|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|oseltamivir (50 mg); three times a day for 10 days
450858|NCT00867139|O1|Outcome|TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
450859|NCT00867139|E3|Reported Event|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
450860|NCT00867139|E2|Reported Event|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450861|NCT00867139|E1|Reported Event|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
450862|NCT00867113|B1|Baseline|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
450863|NCT00867113|P1|Participant Flow|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
450864|NCT00867113|O1|Outcome|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
450865|NCT00867113|O1|Outcome|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
450866|NCT00867113|O1|Outcome|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
450867|NCT00867113|O1|Outcome|Imatinib|All subjects received in tablet form imatinib (STI571) 400 mg once daily.
450868|NCT00867113|E1|Reported Event|Imatinib|Imatinib
450869|NCT00867087|B1|Baseline|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450870|NCT00867087|P1|Participant Flow|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|Intravenous (IV) inotuzumab ozogamicin 1.8 milligrams per square meter (mg/m^2) given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450871|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450872|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450873|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450874|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450875|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450876|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450877|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450878|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450879|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
451051|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451290|NCT00865904|B5|Baseline|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
450880|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450881|NCT00867087|O1|Outcome|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450882|NCT00867087|E1|Reported Event|Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given on Day 2 of a 21-day cycle in combination with IV rituximab 375 mg/m^2 given on Day -2 (Cycle 1 only) and Day 1 as an induction therapy for a planned minimum of 3 cycles and a maximum of 6 cycles.
450883|NCT00867035|B3|Baseline|Total|Total of all reporting groups
450884|NCT00867035|B2|Baseline|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450885|NCT00867035|B1|Baseline|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450886|NCT00867035|P2|Participant Flow|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450887|NCT00867035|P1|Participant Flow|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450888|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450889|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450890|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450891|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450892|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450893|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450894|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450895|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450896|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450897|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450898|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450899|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450900|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450901|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450902|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450903|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450904|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450905|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450906|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450907|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450908|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450909|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450910|NCT00867035|E2|Reported Event|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
450911|NCT00867035|E1|Reported Event|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
450912|NCT00867009|B1|Baseline|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
450913|NCT00867009|P1|Participant Flow|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
451018|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
450914|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
450915|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
450916|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
450917|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
450918|NCT00867009|E1|Reported Event|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
450919|NCT00866918|B3|Baseline|Total|Total of all reporting groups
450920|NCT00866918|B2|Baseline|High Risk|WBC>=10,000/MicroLiter
450921|NCT00866918|B1|Baseline|Standard Risk|WBC<10,000/MicroLiter
450922|NCT00866918|P2|Participant Flow|High Risk|WBC>=10,000/MicroLiter
450923|NCT00866918|P1|Participant Flow|Standard Risk|WBC<10,000/MicroLiter
450924|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
450925|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
450926|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
450927|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
450928|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
450929|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
450930|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
450931|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
450932|NCT00866918|E2|Reported Event|High Risk|WBC>=10,000/MicroLiter
450933|NCT00866918|E1|Reported Event|Standard Risk|WBC<10,000/MicroLiter
450934|NCT00866905|B1|Baseline|Arm/Group 1|
450935|NCT00866905|P1|Participant Flow|Ixabepilone/Cyclophosphamide|"Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours~Cyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines"
450936|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
450937|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
450938|NCT00866905|E1|Reported Event|Ixabepilone/Cyclophosphamide|
450939|NCT00866814|B1|Baseline|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450940|NCT00866814|P1|Participant Flow|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450941|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450942|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450943|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450944|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450945|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450946|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450947|NCT00866814|E1|Reported Event|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
450948|NCT00866788|B5|Baseline|Total|Total of all reporting groups
450949|NCT00866788|B4|Baseline|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450950|NCT00866788|B3|Baseline|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450951|NCT00866788|B2|Baseline|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450952|NCT00866788|B1|Baseline|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
457225|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
450953|NCT00866788|P4|Participant Flow|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450954|NCT00866788|P3|Participant Flow|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450955|NCT00866788|P2|Participant Flow|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450956|NCT00866788|P1|Participant Flow|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450957|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450958|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450959|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450960|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450961|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450962|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450963|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450964|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450965|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450966|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450967|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450968|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450969|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450970|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450971|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450972|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
457226|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
450973|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450974|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450975|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450976|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450977|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450978|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450979|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450980|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450981|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450982|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450983|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450984|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450985|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450986|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450987|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450988|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450989|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450990|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450991|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450992|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
451050|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
450993|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450994|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450995|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450996|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450997|NCT00866788|E4|Reported Event|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450998|NCT00866788|E3|Reported Event|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
450999|NCT00866788|E2|Reported Event|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
451000|NCT00866788|E1|Reported Event|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
451001|NCT00866775|B3|Baseline|Total|Total of all reporting groups
451002|NCT00866775|B2|Baseline|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451003|NCT00866775|B1|Baseline|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451004|NCT00866775|P2|Participant Flow|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451005|NCT00866775|P1|Participant Flow|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451006|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451007|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451008|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451009|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451010|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451011|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451012|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451013|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451014|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451015|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451016|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451017|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451019|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451020|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451021|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451022|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451023|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451024|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451025|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451026|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451027|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451028|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451029|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451030|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451031|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451032|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451033|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451034|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451035|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451036|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451037|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451038|NCT00866775|E2|Reported Event|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
451039|NCT00866775|E1|Reported Event|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
451040|NCT00866723|B1|Baseline|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
451041|NCT00866723|P1|Participant Flow|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
451042|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
451043|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
451044|NCT00866723|E1|Reported Event|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
451045|NCT00866697|B3|Baseline|Total|Total of all reporting groups
451046|NCT00866697|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451047|NCT00866697|B1|Baseline|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451048|NCT00866697|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451049|NCT00866697|P1|Participant Flow|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451052|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451053|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451054|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451055|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451056|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451057|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451058|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451059|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451060|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451061|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451062|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451063|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451064|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451065|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451066|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451067|NCT00866697|O1|Outcome|Placebo|Placebo
451068|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451069|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451070|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451071|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451072|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451073|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451074|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451075|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451076|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451077|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451078|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451079|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451080|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451081|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451082|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451083|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451084|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451085|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451086|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451087|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451088|NCT00866697|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
451089|NCT00866697|E1|Reported Event|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
451090|NCT00866658|B3|Baseline|Total|Total of all reporting groups
451091|NCT00866658|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
451092|NCT00866658|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
451093|NCT00866658|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
451094|NCT00866658|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
451095|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451096|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451097|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451098|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451099|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451100|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451101|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451102|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451103|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451104|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451105|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451106|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451107|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451108|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451109|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451110|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451111|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451112|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451113|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451114|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451115|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451116|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451117|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451118|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451119|NCT00866658|E2|Reported Event|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
451120|NCT00866658|E1|Reported Event|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
451121|NCT00866606|B1|Baseline|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451122|NCT00866606|P1|Participant Flow|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451123|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451124|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451125|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451126|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451127|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451128|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451129|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451130|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451131|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451132|NCT00866606|E1|Reported Event|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
451133|NCT00866359|B3|Baseline|Total|Total of all reporting groups
451134|NCT00866359|B2|Baseline|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451135|NCT00866359|B1|Baseline|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
451136|NCT00866359|P4|Participant Flow|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast BID tablets in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
451137|NCT00866359|P3|Participant Flow|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
451138|NCT00866359|P2|Participant Flow|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451139|NCT00866359|P1|Participant Flow|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
451140|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451141|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451142|NCT00866359|O2|Outcome|Apremilast 30 mg/Apremilast 30mg BID|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451143|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451144|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451145|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451146|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451147|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451148|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451149|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451150|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451179|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
451151|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
451152|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Treatment and Extension Phases (Days 1 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
451153|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
451154|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID were titrated to 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
451155|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
451156|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
451157|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase .
451158|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
451159|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
451160|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially administered to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
451161|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
451162|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
451163|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
451164|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451165|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
451166|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451167|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
451168|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451169|NCT00866359|O1|Outcome|Placebo|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
451170|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451171|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
451172|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451173|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
451174|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451175|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
451176|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451177|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
451178|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451180|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451181|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
451182|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451183|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
451184|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451185|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
451186|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
451187|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
451188|NCT00866359|E3|Reported Event|Week 24: Apremilast 30 mg BID|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Includes data through Week 24 for participants who were treated with Apremilast started at Week 0 and data from Week 12 through Week 24 for participants who were treated with Apremilast started at Week 12.
451189|NCT00866359|E2|Reported Event|Week 12: Apremilast 30 mg BID|Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Includes data through Week 12 for all participants randomized to 30mg Apremilast BID.
451190|NCT00866359|E1|Reported Event|Week 12: Placebo BID|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 12 for all participants randomized to placebo.
451191|NCT00866320|B1|Baseline|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
451192|NCT00866320|P1|Participant Flow|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
451193|NCT00866320|O1|Outcome|Sorafenib|Patients receive Sorafenib twice a day until disease progression or toxicity
451194|NCT00866320|O1|Outcome|Sorafenib|Sorafenib twice a day until progression or toxicity
451195|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
451196|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
451197|NCT00866320|E1|Reported Event|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
451198|NCT00866307|B1|Baseline|Induction|All Patients
451199|NCT00866307|P3|Participant Flow|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
451200|NCT00866307|P2|Participant Flow|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM)
451201|NCT00866307|P1|Participant Flow|Induction|All Patients
451202|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
451203|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
451204|NCT00866307|E3|Reported Event|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
451205|NCT00866307|E2|Reported Event|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM).
451206|NCT00866307|E1|Reported Event|Induction|All Patients
451207|NCT00866294|B4|Baseline|Total|Total of all reporting groups
451208|NCT00866294|B3|Baseline|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
451209|NCT00866294|B2|Baseline|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
451210|NCT00866294|B1|Baseline|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
457227|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
451211|NCT00866294|P3|Participant Flow|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
451212|NCT00866294|P2|Participant Flow|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
451213|NCT00866294|P1|Participant Flow|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
451214|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451215|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451216|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
451217|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451218|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451219|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
451220|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451221|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451222|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
451223|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451224|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451225|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
451247|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
451291|NCT00865904|B4|Baseline|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
457228|NCT00852917|O4|Outcome|4: Placebo|
451226|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451227|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451228|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
451229|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451230|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
451231|NCT00866294|O1|Outcome|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
451232|NCT00866294|E7|Reported Event|Paroxetine IR, Total|All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
451233|NCT00866294|E6|Reported Event|Paroxetine IR 20-40 mg/Day|An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
451234|NCT00866294|E5|Reported Event|Paroxetine IR 10-40 mg/Day|An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
451235|NCT00866294|E4|Reported Event|Paroxetine CR, Total|All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day
451236|NCT00866294|E3|Reported Event|Paroxetine CR 25-50 mg/Day|An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
451237|NCT00866294|E2|Reported Event|Paroxetine CR 12.5-50 mg/Day|An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
451238|NCT00866294|E1|Reported Event|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
451239|NCT00866281|B3|Baseline|Total|Total of all reporting groups
451240|NCT00866281|B2|Baseline|Cohort 2: Midostaurin (60 mg/m^2)|Participants received body-weight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
451241|NCT00866281|B1|Baseline|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received body-weight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
451242|NCT00866281|P2|Participant Flow|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
451243|NCT00866281|P1|Participant Flow|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 twice daily (bid) through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
451244|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
451245|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
451246|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
451289|NCT00865904|B6|Baseline|Total|Total of all reporting groups
457229|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
451248|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
451249|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
451250|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
451251|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
451252|NCT00866281|O2|Outcome|MLLr-ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
451253|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
451254|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
451255|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
451256|NCT00866281|E2|Reported Event|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
451257|NCT00866281|E1|Reported Event|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
451258|NCT00866177|B1|Baseline|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
451259|NCT00866177|P1|Participant Flow|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
451260|NCT00866177|O1|Outcome|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
451261|NCT00866177|E1|Reported Event|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
451262|NCT00866047|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451263|NCT00866047|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
451264|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451265|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451266|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451267|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451268|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451269|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451270|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451271|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451272|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451273|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451274|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451275|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451276|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451277|NCT00866047|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
451278|NCT00866034|B3|Baseline|Total|Total of all reporting groups
451279|NCT00866034|B2|Baseline|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
451280|NCT00866034|B1|Baseline|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
451281|NCT00866034|P2|Participant Flow|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
451282|NCT00866034|P1|Participant Flow|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
451283|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
451284|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
451285|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
451286|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
451287|NCT00866034|E2|Reported Event|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
451288|NCT00866034|E1|Reported Event|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
451292|NCT00865904|B3|Baseline|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451293|NCT00865904|B2|Baseline|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451294|NCT00865904|B1|Baseline|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451295|NCT00865904|P5|Participant Flow|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451296|NCT00865904|P4|Participant Flow|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451297|NCT00865904|P3|Participant Flow|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451298|NCT00865904|P2|Participant Flow|VX-809, 25 mg|VX-809, 25 milligram (mg) capsule orally once daily for 28 days.
451299|NCT00865904|P1|Participant Flow|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451300|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451301|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451302|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451303|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451304|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451305|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451306|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451307|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451308|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451309|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451310|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451311|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451312|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451313|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451314|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451315|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451316|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451317|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451318|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451319|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451320|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451321|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451322|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451323|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451324|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451325|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451326|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451327|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451328|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451329|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451330|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451331|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451332|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451333|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451334|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451335|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451336|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451337|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451338|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451339|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451340|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451341|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451342|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451343|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451344|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451345|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451346|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451347|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451348|NCT00865904|E5|Reported Event|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
451349|NCT00865904|E4|Reported Event|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
451350|NCT00865904|E3|Reported Event|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
451351|NCT00865904|E2|Reported Event|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
451352|NCT00865904|E1|Reported Event|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
451353|NCT00865709|B3|Baseline|Total|Total of all reporting groups
451544|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451545|NCT00864851|E4|Reported Event|Overall|Total of all reporting groups.
451354|NCT00865709|B2|Baseline|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451355|NCT00865709|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451356|NCT00865709|P2|Participant Flow|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451357|NCT00865709|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451358|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451359|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451360|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451361|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451362|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451363|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451364|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451365|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451366|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451367|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451368|NCT00865709|E4|Reported Event|Matching Placebo + mFOLFOX6 (OS Update)|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451369|NCT00865709|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451370|NCT00865709|E2|Reported Event|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
451371|NCT00865709|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
451372|NCT00865514|B1|Baseline|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
451373|NCT00865514|P1|Participant Flow|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
451374|NCT00865514|O1|Outcome|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
457230|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
451375|NCT00865514|O1|Outcome|The Interaction of DCA and/or Tyrosine Breakdown Products|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
451376|NCT00865514|E1|Reported Event|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
451377|NCT00865345|B1|Baseline|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
451378|NCT00865345|P1|Participant Flow|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
451379|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
451380|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
451381|NCT00865345|E1|Reported Event|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
451382|NCT00865306|B3|Baseline|Total|Total of all reporting groups
451383|NCT00865306|B2|Baseline|No Intervention (Wait-list Controls)|
451384|NCT00865306|B1|Baseline|Active CBT|
451385|NCT00865306|P2|Participant Flow|No Intervention (Wait-list Controls)|This was a 6-month wait-list control condition in which children received no intervention. After participating in the control condition, families who wanted it were offered the opportunity to receive the CBT intervention.
451386|NCT00865306|P1|Participant Flow|Active CBT|This was parent-child CBT, administered to families individually over 6 months, and including six 1-hour parent-only sessions, followed by 8-13 1-hour child-parent sessions, and one final 1-hour parent-only session.
451387|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
451388|NCT00865306|O1|Outcome|Active CBT|
451389|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
451390|NCT00865306|O1|Outcome|Active CBT|
451391|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
451392|NCT00865306|O1|Outcome|Active CBT|
451393|NCT00865306|E2|Reported Event|No Intervention (Wait-list Controls)|
451394|NCT00865306|E1|Reported Event|Active CBT|
451395|NCT00865202|B3|Baseline|Total|Total of all reporting groups
451396|NCT00865202|B2|Baseline|Placebo|similar appearing placebo
451397|NCT00865202|B1|Baseline|L-tryptophan|L-tryptophan 1 gm enterally TID starting the evening of the operation
451398|NCT00865202|P2|Participant Flow|Placebo|Similar appearing placebo
451399|NCT00865202|P1|Participant Flow|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
451400|NCT00865202|O2|Outcome|Placebo|Similar appearing placebo
451401|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
451402|NCT00865202|O2|Outcome|Placebo|Similar appearing placebo
451403|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
451404|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
451405|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
451406|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
451407|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
451408|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
451409|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
451410|NCT00865202|E2|Reported Event|Placebo|Similar appearing placebo
451411|NCT00865202|E1|Reported Event|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
451412|NCT00865189|B3|Baseline|Total|Total of all reporting groups
451413|NCT00865189|B2|Baseline|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451414|NCT00865189|B1|Baseline|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451415|NCT00865189|P2|Participant Flow|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451503|NCT00864916|B1|Baseline|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
451416|NCT00865189|P1|Participant Flow|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
451417|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451418|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451419|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451420|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451421|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451422|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451423|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451424|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451425|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451546|NCT00864851|E3|Reported Event|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451547|NCT00864851|E2|Reported Event|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451426|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451427|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451428|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451429|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451430|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451431|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451432|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451433|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451434|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451435|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451436|NCT00865189|O2|Outcome|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
457231|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
451437|NCT00865189|O1|Outcome|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451438|NCT00865189|E2|Reported Event|Arm B (Bevacizumab, Chemoradiotherapy)|In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
451439|NCT00865189|E1|Reported Event|Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)|In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
451440|NCT00865124|B4|Baseline|Total|Total of all reporting groups
451441|NCT00865124|B3|Baseline|Placebo Capsule|Placebo: Placebo capsule daily
451442|NCT00865124|B2|Baseline|Hydrochlorothiazide + Potassium|Hydrochlorothiazide + potassium: hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
451443|NCT00865124|B1|Baseline|Spironolactone (MR Blockade)|Spironolactone: 25 mg capsule daily for 6 months
451444|NCT00865124|P3|Participant Flow|Placebo|Placebo capsule daily
451445|NCT00865124|P2|Participant Flow|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
451446|NCT00865124|P1|Participant Flow|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
451447|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
451448|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
451449|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
451450|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
451451|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
451452|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
451453|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
451454|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
451455|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
451456|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
451457|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
451458|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
451459|NCT00865124|E3|Reported Event|Placebo|Placebo capsule daily
451460|NCT00865124|E2|Reported Event|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
451461|NCT00865124|E1|Reported Event|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
451462|NCT00865098|B1|Baseline|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451463|NCT00865098|P1|Participant Flow|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451464|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451465|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451548|NCT00864851|E1|Reported Event|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
457232|NCT00852917|O4|Outcome|4: Placebo|
451466|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451467|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451468|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451469|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451470|NCT00865098|E1|Reported Event|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
451471|NCT00865046|B4|Baseline|Total|Total of all reporting groups
451472|NCT00865046|B3|Baseline|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451473|NCT00865046|B2|Baseline|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451474|NCT00865046|B1|Baseline|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
451475|NCT00865046|P3|Participant Flow|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451476|NCT00865046|P2|Participant Flow|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451477|NCT00865046|P1|Participant Flow|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
451478|NCT00865046|O3|Outcome|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451479|NCT00865046|O2|Outcome|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451480|NCT00865046|O1|Outcome|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
451481|NCT00865046|E3|Reported Event|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451504|NCT00864916|P2|Participant Flow|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
451482|NCT00865046|E2|Reported Event|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
451483|NCT00865046|E1|Reported Event|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
451484|NCT00865020|B3|Baseline|Total|Total of all reporting groups
451485|NCT00865020|B2|Baseline|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451486|NCT00865020|B1|Baseline|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451487|NCT00865020|P2|Participant Flow|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451488|NCT00865020|P1|Participant Flow|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451489|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451490|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451491|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451492|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451493|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451494|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451495|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451496|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451497|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451498|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451499|NCT00865020|E2|Reported Event|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
451500|NCT00865020|E1|Reported Event|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
451501|NCT00864916|B3|Baseline|Total|Total of all reporting groups
451502|NCT00864916|B2|Baseline|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
451542|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451543|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451505|NCT00864916|P1|Participant Flow|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
451506|NCT00864916|O2|Outcome|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
451507|NCT00864916|O1|Outcome|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
451508|NCT00864916|E2|Reported Event|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
451509|NCT00864916|E1|Reported Event|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
451510|NCT00864851|B4|Baseline|Total|Total of all reporting groups
451511|NCT00864851|B3|Baseline|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451512|NCT00864851|B2|Baseline|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451513|NCT00864851|B1|Baseline|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451514|NCT00864851|P3|Participant Flow|Replagal 0.4 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451515|NCT00864851|P2|Participant Flow|Replagal 0.2 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451516|NCT00864851|P1|Participant Flow|Replagal 0.2 mg/kg, IV, Every Other Week|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451517|NCT00864851|O4|Outcome|Overall|Total of all reporting groups.
451518|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451519|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451520|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451521|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451522|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451523|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451524|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451525|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451526|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451527|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451528|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451529|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451530|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451531|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451532|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451533|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451534|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451535|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451536|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451537|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451538|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451539|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
451540|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
451541|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
451549|NCT00864708|B1|Baseline|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
451550|NCT00864708|P1|Participant Flow|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
451551|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
451552|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
451553|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
451554|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
451555|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
451556|NCT00864708|O1|Outcome|Arm 1|gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
451557|NCT00864708|E1|Reported Event|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
451558|NCT00864682|B4|Baseline|Total|Total of all reporting groups
451559|NCT00864682|B3|Baseline|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
451560|NCT00864682|B2|Baseline|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
451561|NCT00864682|B1|Baseline|Control Arm|saline pretreatment, saline plus propofol admixture
451562|NCT00864682|P3|Participant Flow|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
451563|NCT00864682|P2|Participant Flow|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
451564|NCT00864682|P1|Participant Flow|Control Arm|saline pretreatment, saline plus propofol admixture
451565|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
451566|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
451567|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
451568|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
451569|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
451570|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
451571|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
451572|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
451573|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
451574|NCT00864682|E3|Reported Event|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
451575|NCT00864682|E2|Reported Event|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
451576|NCT00864682|E1|Reported Event|Control Arm|saline pretreatment, saline plus propofol admixture
451577|NCT00864539|B7|Baseline|Total|Total of all reporting groups
451578|NCT00864539|B6|Baseline|Placebo|Subjects receiving daily placebo containing 1 g starch
451579|NCT00864539|B5|Baseline|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
451580|NCT00864539|B4|Baseline|Plain Juice|subjects receiving plain orange juice
451581|NCT00864539|B3|Baseline|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
451582|NCT00864539|B2|Baseline|Plain Milk|daily intake of 200 mL plain milk
451583|NCT00864539|B1|Baseline|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
451584|NCT00864539|P6|Participant Flow|Placebo|Subjects receiving daily placebo containing 1 g starch
451585|NCT00864539|P5|Participant Flow|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
451586|NCT00864539|P4|Participant Flow|Plain Juice|subjects receiving plain orange juice
451587|NCT00864539|P3|Participant Flow|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
451588|NCT00864539|P2|Participant Flow|Plain Milk|daily intake of 200 mL plain milk
451589|NCT00864539|P1|Participant Flow|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
451590|NCT00864539|O6|Outcome|Placebo|Subjects receiving daily placebo containing 1 g starch
451591|NCT00864539|O5|Outcome|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
451592|NCT00864539|O4|Outcome|Plain Juice|subjects receiving plain orange juice
451593|NCT00864539|O3|Outcome|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
451594|NCT00864539|O2|Outcome|Plain Milk|daily intake of 200 mL plain milk
451595|NCT00864539|O1|Outcome|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
451596|NCT00864539|E6|Reported Event|Placebo|Subjects receiving daily placebo containing 1 g starch
451597|NCT00864539|E5|Reported Event|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
451598|NCT00864539|E4|Reported Event|Plain Juice|subjects receiving plain orange juice
451599|NCT00864539|E3|Reported Event|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
451600|NCT00864539|E2|Reported Event|Plain Milk|daily intake of 200 mL plain milk
451601|NCT00864539|E1|Reported Event|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
451602|NCT00864513|B1|Baseline|Chemotherapy|pemetrexed
451603|NCT00864513|P1|Participant Flow|Chemotherapy|Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
451604|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
451610|NCT00864383|B3|Baseline|Regimen 3 - 2EMRZ/2MR (Ethambutol)|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451611|NCT00864383|B2|Baseline|Regimen 2 - 2MHRZ/2MHR (Isoniazid)|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451612|NCT00864383|B1|Baseline|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451613|NCT00864383|P3|Participant Flow|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451614|NCT00864383|P2|Participant Flow|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451615|NCT00864383|P1|Participant Flow|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451616|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451617|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451618|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451766|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451619|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451620|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451621|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451622|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451623|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451624|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451625|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451626|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451627|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451767|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451628|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451629|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451630|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451631|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451632|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451633|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451634|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451635|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451636|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451768|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451637|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451638|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451639|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451640|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451641|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451642|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451643|NCT00864383|E3|Reported Event|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451644|NCT00864383|E2|Reported Event|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451645|NCT00864383|E1|Reported Event|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
451646|NCT00864253|B3|Baseline|Total|Total of all reporting groups
451647|NCT00864253|B2|Baseline|Dacarbazine Arm B 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451648|NCT00864253|B1|Baseline|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451649|NCT00864253|P2|Participant Flow|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451650|NCT00864253|P1|Participant Flow|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451651|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451652|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451653|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451654|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451655|NCT00864253|O2|Outcome|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451656|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451657|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451658|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451659|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451660|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451661|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451662|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451663|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451664|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451665|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451666|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451667|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451668|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451669|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451670|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451671|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451672|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451673|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451674|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451675|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451676|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 every 4 weeks
451677|NCT00864253|E2|Reported Event|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
451678|NCT00864253|E1|Reported Event|ABI-007 Arm A|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
451679|NCT00864227|B1|Baseline|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451680|NCT00864227|P1|Participant Flow|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451681|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451682|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451683|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451684|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451685|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451686|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451687|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451688|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451689|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451690|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451691|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451692|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451693|NCT00864227|E1|Reported Event|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
451694|NCT00864123|B3|Baseline|Total|Total of all reporting groups
451695|NCT00864123|B2|Baseline|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451696|NCT00864123|B1|Baseline|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451697|NCT00864123|P2|Participant Flow|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451698|NCT00864123|P1|Participant Flow|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451699|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451700|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451701|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451702|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451703|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451704|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451705|NCT00864123|E2|Reported Event|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451706|NCT00864123|E1|Reported Event|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
451707|NCT00864084|B1|Baseline|Pulmonary Rehabilitation|People with respiratory disease
451708|NCT00864084|P1|Participant Flow|Pulmonary Rehabilitation|An 8-week out-patient pulmonary rehabilitation program.
451709|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
451710|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
451711|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
451712|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
451713|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
451714|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
451715|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
451716|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
451717|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
451718|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
451719|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
451720|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
451721|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
451722|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
451723|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
451724|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
451725|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
451726|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
451727|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
451728|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
451729|NCT00864084|E1|Reported Event|Study Participation|Participant data collection at baseline (pre-pulmonary rehabilitation), participation in an 8-week outpatient pulmonary rehabilitation program and data collection at follow-up (post-pulmonary rehabilitation).
451730|NCT00864032|B1|Baseline|Phase I|
451731|NCT00864032|P3|Participant Flow|Sorafenib 400/400|"Dose level 3 sorafenib 400 mg PO BID with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
451732|NCT00864032|P2|Participant Flow|Sorafenib 200/400|"Dose level 2 sorafenib 200 mg PO Q AM and 400 mg PO Q PM with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.~Traditional 3+3 dose escalation Phase I trial. Cohort 2 enrolled after completion of all 3 participants in dose level 1."
451733|NCT00864032|P1|Participant Flow|Sorafenib 200/200|"Dose level 1 sorafenib 200 bid with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
451734|NCT00864032|O2|Outcome|Sorafenib 200/400|
451735|NCT00864032|O1|Outcome|Sorafenib 200/200|
451736|NCT00864032|E2|Reported Event|Sorafenib 200/400|Dose level 2. Sorafenib 200 mg PO Q AM and 400 mg PO Q PM
451737|NCT00864032|E1|Reported Event|Sorafenib 200/200|Dose level 1. Sorafenib 200 mg PO BID
451738|NCT00863798|B4|Baseline|Total|Total of all reporting groups
451739|NCT00863798|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451740|NCT00863798|B2|Baseline|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451741|NCT00863798|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451742|NCT00863798|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451743|NCT00863798|P2|Participant Flow|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451744|NCT00863798|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451745|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451746|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451747|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451748|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451749|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451750|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451751|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451752|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451753|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451754|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451755|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451756|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451757|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451758|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451759|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451760|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451761|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451762|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451763|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451764|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451765|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
457233|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
451769|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451770|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451771|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451772|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451773|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451774|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451775|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451776|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451777|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451778|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451779|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451780|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451781|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451782|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451783|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451784|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451785|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451786|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451787|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451788|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451789|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451790|NCT00863798|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
451791|NCT00863798|E2|Reported Event|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
451792|NCT00863798|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
451793|NCT00863746|B3|Baseline|Total|Total of all reporting groups
451794|NCT00863746|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451795|NCT00863746|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451796|NCT00863746|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451797|NCT00863746|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451798|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451799|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451800|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451801|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451802|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451803|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451804|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451805|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451806|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451807|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451808|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451809|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451810|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451811|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451812|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451813|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451814|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451815|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451816|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451817|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
451818|NCT00863746|E2|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
451819|NCT00863746|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID)
451820|NCT00863707|B3|Baseline|Total|Total of all reporting groups
451821|NCT00863707|B2|Baseline|Regadenoson|0.4 mg/5 mL intravenous bolus injection
451822|NCT00863707|B1|Baseline|Placebo|Matching intravenous (IV) bolus injection
451823|NCT00863707|P2|Participant Flow|Regadenoson|0.4 mg/5 mL intravenous bolus injection
451824|NCT00863707|P1|Participant Flow|Placebo|Matching intravenous (IV) bolus injection
457234|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
451825|NCT00863707|O2|Outcome|Regadenoson|0.4 mg/5 mL intravenous bolus injection
451826|NCT00863707|O1|Outcome|Placebo|Matching intravenous (IV) bolus injection
451827|NCT00863707|E2|Reported Event|Regadenoson|0.4 mg/5 mL intravenous bolus injection
451828|NCT00863707|E1|Reported Event|Placebo|Matching intravenous (IV) bolus injection
451829|NCT00863655|B3|Baseline|Total|Total of all reporting groups
451830|NCT00863655|B2|Baseline|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451831|NCT00863655|B1|Baseline|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451832|NCT00863655|P2|Participant Flow|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451833|NCT00863655|P1|Participant Flow|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451834|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451835|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451836|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451837|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451838|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451839|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451840|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451841|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451842|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451843|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451844|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451845|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451846|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451847|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451848|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451849|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451850|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451851|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451852|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451853|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451854|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451855|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451856|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451857|NCT00863655|E2|Reported Event|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
451858|NCT00863655|E1|Reported Event|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
451859|NCT00863551|B1|Baseline|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451860|NCT00863551|P1|Participant Flow|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451861|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451862|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451863|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451864|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451865|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451866|NCT00863551|E1|Reported Event|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
451867|NCT00863512|B3|Baseline|Total|Total of all reporting groups
451868|NCT00863512|B2|Baseline|Arm II (Observation)|Patients receive standard care (observation).
451869|NCT00863512|B1|Baseline|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
451870|NCT00863512|P2|Participant Flow|Arm II (Observation)|Patients receive standard care (observation).
451871|NCT00863512|P1|Participant Flow|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
451872|NCT00863512|O2|Outcome|Arm II (Observation)|Patients receive standard care (observation).
451873|NCT00863512|O1|Outcome|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
451874|NCT00863512|E2|Reported Event|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
451875|NCT00863512|E1|Reported Event|Arm II (Observation)|Patients receive standard care (observation).
451876|NCT00863434|B1|Baseline|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
451877|NCT00863434|P1|Participant Flow|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
451878|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
451879|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
451880|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
451881|NCT00863434|E1|Reported Event|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
451882|NCT00863356|B1|Baseline|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
451883|NCT00863356|P1|Participant Flow|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
451884|NCT00863356|O1|Outcome|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
451885|NCT00863356|E1|Reported Event|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
451886|NCT00863343|B3|Baseline|Total|Total of all reporting groups
451887|NCT00863343|B2|Baseline|Participants w/o Disease|Participants without Flu A by reference method
451888|NCT00863343|B1|Baseline|Participants w/ Disease|Positive for Flu A by reference test
451889|NCT00863343|P2|Participant Flow|Participants w/o Disease|Participants without Flu A by reference method
451890|NCT00863343|P1|Participant Flow|Participants w/ Disease|Positive for Flu A by reference test
451891|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
451892|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
451893|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
451894|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
451895|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
451896|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
451897|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
451898|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
451899|NCT00863343|E2|Reported Event|Participants w/o Disease|Participants without Flu by reference method
451900|NCT00863343|E1|Reported Event|Participants With Disease|Positive for Flu by reference test
451901|NCT00863330|B1|Baseline|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
451902|NCT00863330|P1|Participant Flow|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
451903|NCT00863330|O1|Outcome|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
451904|NCT00863330|E1|Reported Event|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
451905|NCT00863317|B3|Baseline|Total|Total of all reporting groups
451906|NCT00863317|B2|Baseline|Sucrose|sucrose: table sugar as placebo daily for 14 days
451907|NCT00863317|B1|Baseline|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
451908|NCT00863317|P2|Participant Flow|Placebo|sucrose: table sugar as placebo daily for 14 days
451909|NCT00863317|P1|Participant Flow|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
451910|NCT00863317|O2|Outcome|Placebo|sucrose: table sugar as placebo daily for 14 days
451911|NCT00863317|O1|Outcome|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
451912|NCT00863317|E2|Reported Event|Placebo|sucrose: table sugar as placebo daily for 14 days
451913|NCT00863317|E1|Reported Event|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
451914|NCT00863109|B1|Baseline|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
451915|NCT00863109|P1|Participant Flow|PEG + RBV (Standard Clinical Practice)|Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
451916|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
451917|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
451918|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
451919|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
451920|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
451921|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
451922|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
451923|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
451924|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
451925|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
451926|NCT00863109|E1|Reported Event|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
451927|NCT00863057|B5|Baseline|Total|Total of all reporting groups
451928|NCT00863057|B4|Baseline|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451939|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451940|NCT00863057|O2|Outcome|Duloxetine|Maximum tolerated daily dose of Duloxetine was reported.
457235|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
451929|NCT00863057|B3|Baseline|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451930|NCT00863057|B2|Baseline|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451931|NCT00863057|B1|Baseline|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451932|NCT00863057|P4|Participant Flow|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451933|NCT00863057|P3|Participant Flow|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451934|NCT00863057|P2|Participant Flow|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451935|NCT00863057|P1|Participant Flow|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
451936|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451937|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451938|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451941|NCT00863057|O1|Outcome|Methadone|Maximum tolerated daily dose of Methadone was reported.
451942|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451943|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451944|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451945|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451946|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451947|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451948|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451949|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451950|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451951|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451952|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451953|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451954|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451955|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451956|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451957|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451958|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451959|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451960|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
452004|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
451961|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451962|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451963|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451964|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451965|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451966|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451967|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451968|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451969|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451970|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451971|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451972|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451973|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451974|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451975|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451976|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451977|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
451978|NCT00863057|E4|Reported Event|Duloxetine Placebo and Methadone Placebo|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
452005|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452043|NCT00862823|E1|Reported Event|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
452044|NCT00862810|B3|Baseline|Total|Total of all reporting groups
451979|NCT00863057|E3|Reported Event|Duloxetine Placebo and Methadone|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
451980|NCT00863057|E2|Reported Event|Duloxetine and Methadone Placebo|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
451981|NCT00863057|E1|Reported Event|Duloxetine and Methadone|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
451982|NCT00862940|B3|Baseline|Total|Total of all reporting groups
451983|NCT00862940|B2|Baseline|Placebo Tablets Twice Daily|
451984|NCT00862940|B1|Baseline|Memantine 10 mg Tablets Twice Daily|
451985|NCT00862940|P2|Participant Flow|Placebo Tablets Twice Daily|
451986|NCT00862940|P1|Participant Flow|Memantine 10 mg Tablets Twice Daily|
451987|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
451988|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
451989|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
451990|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
451991|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
451992|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
451993|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
451994|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
451995|NCT00862940|E2|Reported Event|Placebo Tablets Twice Daily|
451996|NCT00862940|E1|Reported Event|Memantine 10 mg Tablets Twice Daily|
451997|NCT00862849|B1|Baseline|All Participants|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C).~Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions.~The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections."
451998|NCT00862849|P6|Participant Flow|Lispro Alone First, Then RHI+rHuPH20, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
451999|NCT00862849|P5|Participant Flow|Lispro Alone First, Then Lispro+rHuPH20, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
452000|NCT00862849|P4|Participant Flow|RHI+rHuPH20 First, Then Lispro Alone, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
452001|NCT00862849|P3|Participant Flow|RHI+rHuPH20 First, Then Lispro+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
452002|NCT00862849|P2|Participant Flow|Lispro+rHuPH20 First, Then Lispro Alone, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
452003|NCT00862849|P1|Participant Flow|Lispro+rHuPH20 First, Then RHI+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
457236|NCT00852917|O4|Outcome|4: Placebo|
452006|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452007|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
452008|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452009|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452010|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
452011|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452012|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452013|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
452014|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452015|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452016|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
452017|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452018|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452019|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
452020|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452021|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452022|NCT00862849|E3|Reported Event|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
452023|NCT00862849|E2|Reported Event|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452024|NCT00862849|E1|Reported Event|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
452025|NCT00862836|B1|Baseline|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452026|NCT00862836|P1|Participant Flow|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452027|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452028|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452029|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452030|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452031|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452032|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452033|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452034|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452035|NCT00862836|E1|Reported Event|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
452036|NCT00862823|B1|Baseline|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
452037|NCT00862823|P2|Participant Flow|Liquid First, Then Tablet|Single dose of Atripla liquid in first intervention period and single dose of Atripla tablet in second intervnetion period
452038|NCT00862823|P1|Participant Flow|Tablet First, Then Liquid|Single dose of Atripla tablet in first intervention period and Single dose of Atripla liquid in second intervnetion period
452039|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
452040|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
452041|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
452042|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
452045|NCT00862810|B2|Baseline|Received Concomitant Vaccines First|Received concomitant vaccines first
452046|NCT00862810|B1|Baseline|Received HPV Vaccine First|Received HPV vaccine first
452047|NCT00862810|P2|Participant Flow|Received Concomitant Vaccines First|Received Concomitant Vaccines First
452048|NCT00862810|P1|Participant Flow|Received HPV Vaccine First|Received HPV vaccine first
452049|NCT00862810|O2|Outcome|Received Concomitant Vaccines First|Received concomitant vaccines first
452050|NCT00862810|O1|Outcome|Received HPV Vaccine First|Received HPV vaccine first
452051|NCT00862810|E2|Reported Event|Received Concomitant Vaccines First|Received concomitant vaccines first
452052|NCT00862810|E1|Reported Event|Received HPV Vaccine First|Received HPV vaccine first
452053|NCT00862784|B1|Baseline|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452054|NCT00862784|P1|Participant Flow|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452055|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452056|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452057|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452058|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452059|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452060|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452101|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
452102|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
452061|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452062|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452063|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452064|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452065|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452066|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452067|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452068|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452069|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452103|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
452104|NCT00862719|E4|Reported Event|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
452105|NCT00862719|E3|Reported Event|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
457237|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
452070|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452071|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452072|NCT00862784|E1|Reported Event|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
452073|NCT00862745|B3|Baseline|Total|Total of all reporting groups
452074|NCT00862745|B2|Baseline|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
452075|NCT00862745|B1|Baseline|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
452076|NCT00862745|P2|Participant Flow|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
452077|NCT00862745|P1|Participant Flow|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
452078|NCT00862745|O2|Outcome|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
452079|NCT00862745|O1|Outcome|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
452080|NCT00862745|E2|Reported Event|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
452081|NCT00862745|E1|Reported Event|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
452082|NCT00862719|B5|Baseline|Total|Total of all reporting groups
452083|NCT00862719|B4|Baseline|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
452084|NCT00862719|B3|Baseline|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
452085|NCT00862719|B2|Baseline|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
452086|NCT00862719|B1|Baseline|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
452087|NCT00862719|P4|Participant Flow|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
452088|NCT00862719|P3|Participant Flow|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
452089|NCT00862719|P2|Participant Flow|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
452090|NCT00862719|P1|Participant Flow|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
452091|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
452092|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
452093|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
452094|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
452095|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
452096|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
452097|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
452098|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
452099|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
452100|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
452106|NCT00862719|E2|Reported Event|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
452107|NCT00862719|E1|Reported Event|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
452108|NCT00862654|B5|Baseline|Total|Total of all reporting groups
452109|NCT00862654|B4|Baseline|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
452110|NCT00862654|B3|Baseline|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
452111|NCT00862654|B2|Baseline|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
452112|NCT00862654|B1|Baseline|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
452113|NCT00862654|P4|Participant Flow|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
452114|NCT00862654|P3|Participant Flow|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
452115|NCT00862654|P2|Participant Flow|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
452116|NCT00862654|P1|Participant Flow|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
452117|NCT00862654|O4|Outcome|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
452118|NCT00862654|O3|Outcome|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
452119|NCT00862654|O2|Outcome|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
452120|NCT00862654|O1|Outcome|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
452121|NCT00862654|E4|Reported Event|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
452122|NCT00862654|E3|Reported Event|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
452123|NCT00862654|E2|Reported Event|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
452124|NCT00862654|E1|Reported Event|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
452125|NCT00862641|B5|Baseline|Total|Total of all reporting groups
452126|NCT00862641|B4|Baseline|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452127|NCT00862641|B3|Baseline|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452128|NCT00862641|B2|Baseline|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452129|NCT00862641|B1|Baseline|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452130|NCT00862641|P4|Participant Flow|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452131|NCT00862641|P3|Participant Flow|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452132|NCT00862641|P2|Participant Flow|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452133|NCT00862641|P1|Participant Flow|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452134|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452135|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452136|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452137|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452138|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452139|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452140|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452141|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452142|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452143|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452144|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452145|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452146|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452147|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452148|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452149|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452150|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452151|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452152|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452153|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452154|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452155|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452156|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452157|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452158|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452159|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452160|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452161|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452162|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452163|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452164|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452165|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452166|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452167|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452168|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452169|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452170|NCT00862641|E4|Reported Event|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452171|NCT00862641|E3|Reported Event|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
452172|NCT00862641|E2|Reported Event|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
452173|NCT00862641|E1|Reported Event|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
452174|NCT00862563|B5|Baseline|Total|Total of all reporting groups
452175|NCT00862563|B4|Baseline|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
452176|NCT00862563|B3|Baseline|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
452177|NCT00862563|B2|Baseline|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
452178|NCT00862563|B1|Baseline|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
452179|NCT00862563|P4|Participant Flow|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
452180|NCT00862563|P3|Participant Flow|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
452181|NCT00862563|P2|Participant Flow|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
452182|NCT00862563|P1|Participant Flow|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
452183|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
452184|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
452185|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
452186|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
452187|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
452188|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
452189|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
452190|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
452191|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
457238|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
452192|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
452193|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
452194|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
452195|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
452196|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
452197|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
452198|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
452199|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
452200|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
452201|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
452202|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
452203|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
452204|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
452205|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
452206|NCT00862563|O1|Outcome|Zonisamide|Zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
452207|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
452208|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
452209|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
452210|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
452211|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
452212|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
452213|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
452214|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
452215|NCT00862563|E4|Reported Event|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
452216|NCT00862563|E3|Reported Event|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
452217|NCT00862563|E2|Reported Event|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
452437|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
452218|NCT00862563|E1|Reported Event|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
452219|NCT00862537|B1|Baseline|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
452220|NCT00862537|P1|Participant Flow|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
452221|NCT00862537|O1|Outcome|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
452222|NCT00862537|E1|Reported Event|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
452223|NCT00862459|B4|Baseline|Total|Total of all reporting groups
452224|NCT00862459|B3|Baseline|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452225|NCT00862459|B2|Baseline|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452226|NCT00862459|B1|Baseline|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
452227|NCT00862459|P3|Participant Flow|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452228|NCT00862459|P2|Participant Flow|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452229|NCT00862459|P1|Participant Flow|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
452230|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452231|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452232|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452233|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452234|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452235|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452236|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452237|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452238|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452239|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452240|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452241|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452242|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452243|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452383|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
452244|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452245|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452246|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452247|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452248|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452249|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452250|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452251|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452252|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452253|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452254|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452255|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452256|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452257|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452258|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452259|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452260|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452261|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452262|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452263|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452264|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452265|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452266|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452267|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452268|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452269|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452270|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452271|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452272|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452273|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452274|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452275|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452276|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452277|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452278|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452279|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452280|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452281|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452282|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452283|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452284|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452285|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452286|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452287|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452288|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452289|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452290|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452291|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452292|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452293|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452294|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452295|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452296|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452297|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452298|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452299|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452300|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452301|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452302|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452303|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452304|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452305|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452306|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452307|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452308|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452309|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452310|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452311|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452312|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452313|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452314|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452315|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452316|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452317|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452318|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452319|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452320|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452321|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452322|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452323|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452324|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452325|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452326|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452327|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452328|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452329|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452330|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452331|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452332|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452333|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452334|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452335|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452336|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452337|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452338|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452339|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452340|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452341|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452342|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452343|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452344|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452345|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452346|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452347|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452348|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452349|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452350|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452351|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452352|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452353|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452354|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452355|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452356|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452357|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452358|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452359|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452360|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452361|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452362|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452363|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452364|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452365|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452366|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452367|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452368|NCT00862459|E4|Reported Event|Optimark~0.1mmol/kg BW|Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452369|NCT00862459|E3|Reported Event|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452370|NCT00862459|E2|Reported Event|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452371|NCT00862459|E1|Reported Event|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
452372|NCT00862277|B4|Baseline|Total|Total of all reporting groups
452373|NCT00862277|B3|Baseline|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
452374|NCT00862277|B2|Baseline|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
452375|NCT00862277|B1|Baseline|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
452376|NCT00862277|P3|Participant Flow|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
452377|NCT00862277|P2|Participant Flow|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
452378|NCT00862277|P1|Participant Flow|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
452379|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
452380|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
452381|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
452382|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
452478|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452384|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
452385|NCT00862277|E3|Reported Event|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
452386|NCT00862277|E2|Reported Event|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
452387|NCT00862277|E1|Reported Event|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
452388|NCT00862251|B4|Baseline|Total|Total of all reporting groups
452389|NCT00862251|B3|Baseline|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452390|NCT00862251|B2|Baseline|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452391|NCT00862251|B1|Baseline|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452392|NCT00862251|P3|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452393|NCT00862251|P2|Participant Flow|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452394|NCT00862251|P1|Participant Flow|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452395|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452396|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452397|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452398|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452399|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452400|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452401|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452402|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452403|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452404|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452405|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452406|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452407|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452408|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452409|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452410|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452411|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452412|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452413|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452414|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452415|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452416|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452417|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452418|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452419|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452420|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452421|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452422|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452423|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452424|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452425|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452426|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452427|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452428|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
452429|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452430|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
452431|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452432|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452433|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452434|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452435|NCT00862251|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452436|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452479|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452438|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452439|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
452440|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452441|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452442|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452443|NCT00862251|E3|Reported Event|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
452444|NCT00862251|E2|Reported Event|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
452445|NCT00862251|E1|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
452446|NCT00862186|B1|Baseline|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
452447|NCT00862186|P1|Participant Flow|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
452448|NCT00862186|O2|Outcome|Resource Helpfulness|Fatigue Facts & Fixes was assessed for amount of resource helpfulness on a 1-5 Likert-type scale.
452449|NCT00862186|O1|Outcome|Resource Use|Fatigue Facts & Fixes was assessed for amount of resource use on a 1-5 Likert-type scale.
452450|NCT00862186|E1|Reported Event|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
452451|NCT00862134|B3|Baseline|Total|Total of all reporting groups
452452|NCT00862134|B2|Baseline|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
452453|NCT00862134|B1|Baseline|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
452454|NCT00862134|P2|Participant Flow|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic Granulocyte Colony-stimulating Factor (G-CSF).
452455|NCT00862134|P1|Participant Flow|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
452456|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
452457|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
452458|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
452459|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
452460|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
452461|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
452462|NCT00862134|E2|Reported Event|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
452463|NCT00862134|E1|Reported Event|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
452464|NCT00862121|B3|Baseline|Total|Total of all reporting groups
452465|NCT00862121|B2|Baseline|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452466|NCT00862121|B1|Baseline|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452467|NCT00862121|P2|Participant Flow|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452468|NCT00862121|P1|Participant Flow|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452469|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452470|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452471|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452472|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452473|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452474|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452475|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452476|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452477|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452480|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452481|NCT00862121|E2|Reported Event|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452482|NCT00862121|E1|Reported Event|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
452483|NCT00862082|B3|Baseline|Total|Total of all reporting groups
452484|NCT00862082|B2|Baseline|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452485|NCT00862082|B1|Baseline|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452486|NCT00862082|P2|Participant Flow|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452487|NCT00862082|P1|Participant Flow|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452488|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
452489|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
452490|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
452491|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
452492|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
452493|NCT00862082|O1|Outcome|PR104|
452494|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
452495|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
452496|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
452497|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
452498|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
452499|NCT00862082|O1|Outcome|PR104|
452500|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
452501|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
452502|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
452503|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
452504|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
452505|NCT00862082|O1|Outcome|PR104|
452506|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
452507|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
452508|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
452509|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
452510|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
452511|NCT00862082|O1|Outcome|PR104|
452512|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
452513|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
452514|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
452515|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
452516|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
452517|NCT00862082|O1|Outcome|PR104|
452518|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
452519|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
452520|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
452521|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
452522|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
452523|NCT00862082|O1|Outcome|PR104|
452524|NCT00862082|O2|Outcome|Cohort 2|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452525|NCT00862082|O1|Outcome|Cohort 1|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452526|NCT00862082|O1|Outcome|Cohorts 1 and 2|770 and 550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452527|NCT00862082|E2|Reported Event|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452528|NCT00862082|E1|Reported Event|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
452529|NCT00861913|B1|Baseline|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452530|NCT00861913|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452531|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452532|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452533|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452534|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452535|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452536|NCT00861913|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
452537|NCT00861757|B5|Baseline|Total|Total of all reporting groups
452538|NCT00861757|B4|Baseline|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452539|NCT00861757|B3|Baseline|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452540|NCT00861757|B2|Baseline|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452541|NCT00861757|B1|Baseline|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452542|NCT00861757|P4|Participant Flow|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452543|NCT00861757|P3|Participant Flow|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452544|NCT00861757|P2|Participant Flow|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452545|NCT00861757|P1|Participant Flow|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452546|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452547|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452548|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452549|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452550|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452551|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452552|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452553|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452554|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452555|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452556|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452557|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452558|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452559|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452560|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452561|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452562|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452563|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452564|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452565|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452566|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452567|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452568|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452569|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452570|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452571|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452572|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452573|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452574|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452575|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452576|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452577|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452578|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452579|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452580|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452581|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452582|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452583|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452584|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452585|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452586|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452587|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452588|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452589|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452590|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
452591|NCT00861757|O3|Outcome|5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
452592|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
452593|NCT00861757|O1|Outcome|Placebo|Drug: Placebo PO, QD (30min after meal) for 12 weeks
452594|NCT00861757|E4|Reported Event|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
452595|NCT00861757|E3|Reported Event|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452596|NCT00861757|E2|Reported Event|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
452597|NCT00861757|E1|Reported Event|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
452598|NCT00861744|B5|Baseline|Total|Total of all reporting groups
452806|NCT00861692|B1|Baseline|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452807|NCT00861692|P1|Participant Flow|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
457239|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
452599|NCT00861744|B4|Baseline|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452600|NCT00861744|B3|Baseline|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452601|NCT00861744|B2|Baseline|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452602|NCT00861744|B1|Baseline|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452603|NCT00861744|P4|Participant Flow|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452604|NCT00861744|P3|Participant Flow|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452605|NCT00861744|P2|Participant Flow|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452606|NCT00861744|P1|Participant Flow|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452607|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452608|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452609|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452610|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452611|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452612|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452613|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452614|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452615|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452616|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452617|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452618|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452619|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452620|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452621|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452622|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
457240|NCT00852917|O4|Outcome|4: Placebo|
452623|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452624|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452625|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452626|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452627|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452628|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452629|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452630|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452631|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452632|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452633|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452634|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452635|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452636|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452637|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452638|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452639|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452640|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452641|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452642|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452643|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452644|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452645|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452646|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452647|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452648|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452649|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452650|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452651|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452652|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452653|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452654|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452655|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452656|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452657|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452658|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452659|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452660|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452661|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452662|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452663|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452664|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452665|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452666|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452667|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452668|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452669|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452670|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452671|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452672|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452673|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452674|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452675|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452676|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452677|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452678|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452679|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452680|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452681|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452682|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452683|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452684|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452685|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452686|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452687|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452688|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452689|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452690|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452691|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452692|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452693|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452694|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452695|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452696|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452697|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452698|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452699|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452700|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452701|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452702|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452703|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452704|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452705|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452706|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452707|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452708|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452709|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452710|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452711|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452712|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452713|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452714|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452715|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452716|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452717|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452718|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452719|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452720|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452721|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452722|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452723|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452724|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452725|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452726|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452727|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452728|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452729|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452730|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452731|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452732|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452733|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452734|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452735|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452736|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452737|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452738|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452739|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452740|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452741|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452742|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452743|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452744|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452745|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452746|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452747|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452748|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452749|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452750|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452751|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452752|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452753|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452754|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452755|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452756|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452757|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452758|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452759|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452760|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452761|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452762|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452763|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452764|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452765|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452766|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452767|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452768|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452769|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452770|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452771|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452772|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452773|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452774|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452775|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452776|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452777|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452778|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452779|NCT00861744|E4|Reported Event|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452780|NCT00861744|E3|Reported Event|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452781|NCT00861744|E2|Reported Event|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452782|NCT00861744|E1|Reported Event|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
452783|NCT00861705|B5|Baseline|Total|Total of all reporting groups
452784|NCT00861705|B4|Baseline|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
452785|NCT00861705|B3|Baseline|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
452786|NCT00861705|B2|Baseline|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
452787|NCT00861705|B1|Baseline|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
452788|NCT00861705|P4|Participant Flow|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
452789|NCT00861705|P3|Participant Flow|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
452790|NCT00861705|P2|Participant Flow|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
452791|NCT00861705|P1|Participant Flow|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
452792|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
452793|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
452794|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
452795|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
452796|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
452797|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
452798|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
452799|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
452800|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
452801|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
452802|NCT00861705|E4|Reported Event|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|carboplatin: Given IV
452803|NCT00861705|E3|Reported Event|Arm 3 (Pac + Carboplatin --> ddAC)|carboplatin: Given IV
452804|NCT00861705|E2|Reported Event|Arm 2 (Pac + Bev --> ddAC + Bev)|bevacizumab: Given IV
452805|NCT00861705|E1|Reported Event|Arm 1 (Pac --> ddAC)|cyclophosphamide: Given IV
452808|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452809|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452810|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452811|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452812|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452813|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452814|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452815|NCT00861692|E1|Reported Event|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
452816|NCT00861614|B3|Baseline|Total|Total of all reporting groups
452817|NCT00861614|B2|Baseline|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed PD, drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452818|NCT00861614|B1|Baseline|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4,7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452819|NCT00861614|P2|Participant Flow|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452820|NCT00861614|P1|Participant Flow|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gray units (Gy) to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452821|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452822|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452823|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452824|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452825|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452826|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
453046|NCT00860405|E2|Reported Event|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
452827|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452828|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452829|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452830|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452831|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452832|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452833|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452834|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452835|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452836|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452837|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452838|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
453122|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
452839|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452840|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452841|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452842|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452843|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452844|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452845|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452846|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452847|NCT00861614|E2|Reported Event|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452848|NCT00861614|E1|Reported Event|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
452849|NCT00861601|B4|Baseline|Total|Total of all reporting groups
452850|NCT00861601|B3|Baseline|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452851|NCT00861601|B2|Baseline|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452852|NCT00861601|B1|Baseline|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452853|NCT00861601|P3|Participant Flow|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
453051|NCT00860314|P2|Participant Flow|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
452854|NCT00861601|P2|Participant Flow|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452855|NCT00861601|P1|Participant Flow|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452856|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452857|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452858|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452859|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452860|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452861|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452862|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452863|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452864|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452865|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452866|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452867|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452868|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452869|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452870|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452871|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452872|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452873|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452874|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452875|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452876|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452877|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452878|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452879|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452880|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452881|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452882|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452883|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
453121|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
452884|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452885|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452886|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452887|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452888|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452889|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452890|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452891|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452892|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452893|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452894|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
452895|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452896|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452897|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
452898|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452899|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452900|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452901|NCT00861601|E3|Reported Event|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452902|NCT00861601|E2|Reported Event|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
452903|NCT00861601|E1|Reported Event|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
452904|NCT00861471|B1|Baseline|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
452905|NCT00861471|P1|Participant Flow|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
452906|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
452907|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
452908|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
452909|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
452910|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
452911|NCT00861471|E1|Reported Event|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
453047|NCT00860405|E1|Reported Event|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
452912|NCT00861341|B1|Baseline|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
452913|NCT00861341|P1|Participant Flow|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
452914|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
452915|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
452916|NCT00861341|E1|Reported Event|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
452917|NCT00861263|B1|Baseline|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
452918|NCT00861263|P1|Participant Flow|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
452919|NCT00861263|O1|Outcome|Spiral Enteroscopy Subjects|All subjects followed up after spiral enteroscopy
452920|NCT00861263|E1|Reported Event|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
452921|NCT00861198|B1|Baseline|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
452922|NCT00861198|P1|Participant Flow|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
452923|NCT00861198|O1|Outcome|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
452924|NCT00861198|E1|Reported Event|ERCP|"Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study.~ERCP as per medical indication: ERCP as per medical indication"
452925|NCT00861146|B3|Baseline|Total|Total of all reporting groups
452926|NCT00861146|B2|Baseline|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452927|NCT00861146|B1|Baseline|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452928|NCT00861146|P2|Participant Flow|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452929|NCT00861146|P1|Participant Flow|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452930|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452931|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452932|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452933|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452934|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452935|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452936|NCT00861146|E2|Reported Event|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452937|NCT00861146|E1|Reported Event|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
452938|NCT00860951|B1|Baseline|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
452939|NCT00860951|P1|Participant Flow|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
452940|NCT00860951|O3|Outcome|Assistive Technology Enironment|Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.
452941|NCT00860951|O2|Outcome|Computer Environment|Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.
452942|NCT00860951|O1|Outcome|BCI Environment|Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.
452943|NCT00860951|E1|Reported Event|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
452944|NCT00860847|B3|Baseline|Total|Total of all reporting groups
452945|NCT00860847|B2|Baseline|Placebo|Patients randomized to placebo
452946|NCT00860847|B1|Baseline|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
452947|NCT00860847|P2|Participant Flow|Placebo|Patients randomized to placebo
452948|NCT00860847|P1|Participant Flow|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
452949|NCT00860847|O2|Outcome|Placebo|Patients randomized to placebo
452950|NCT00860847|O1|Outcome|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
452951|NCT00860847|E2|Reported Event|Placebo|Patients randomized to placebo
452952|NCT00860847|E1|Reported Event|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
452953|NCT00860795|B3|Baseline|Total|Total of all reporting groups
452954|NCT00860795|B2|Baseline|Placebo|25 ml daily in 2 divided doses for 10 days
452955|NCT00860795|B1|Baseline|Echinacea|25 ml daily in 2 divided doses for 10 days
452956|NCT00860795|P2|Participant Flow|Placebo|25 ml daily in 2 divided doses for 10 days
452957|NCT00860795|P1|Participant Flow|Echinacea|25 ml daily in 2 divided doses for 10 days
452958|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
452959|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
452960|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
452961|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
452962|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
452963|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
452964|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
452965|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
452966|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
452967|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
452968|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
452969|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
452970|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
452971|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
452972|NCT00860795|E2|Reported Event|Placebo|25 ml daily in 2 divided doses for 10 days
452973|NCT00860795|E1|Reported Event|Echinacea|25 ml daily in 2 divided doses for 10 days
452974|NCT00860743|B7|Baseline|Total|Total of all reporting groups
452975|NCT00860743|B6|Baseline|Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo|We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
452976|NCT00860743|B5|Baseline|Aim 2 - OSA - Hypoxia - Antioxidant/Placebo|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
453048|NCT00860314|B3|Baseline|Total|Total of all reporting groups
453049|NCT00860314|B2|Baseline|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
453050|NCT00860314|B1|Baseline|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
452977|NCT00860743|B4|Baseline|Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
452978|NCT00860743|B3|Baseline|Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
452979|NCT00860743|B2|Baseline|Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
452980|NCT00860743|B1|Baseline|Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
452981|NCT00860743|P2|Participant Flow|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
452982|NCT00860743|P1|Participant Flow|OSA/Healthy - Males/Females - Wake/Sleep|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
452983|NCT00860743|O1|Outcome|OSA/HEALTHY - HYPOXIA - ANTIOXIDANT/PLACEBO|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
452984|NCT00860743|O1|Outcome|OSA/HEALTHY - MALES/FEMALES - WAKE/SLEEP|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
452985|NCT00860743|E2|Reported Event|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
452986|NCT00860743|E1|Reported Event|Arm 1|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
452987|NCT00860535|B1|Baseline|Ph+ CML or Ph+ ALL|Growth Factor Signature (GFS) biomarker evaluation in participants with blast phase Ph+ CML or Ph+ ALL who were treated with imatinib, dasatinib or nilotinib as per standard of care.
452988|NCT00860535|P1|Participant Flow|Ph+ CML or Ph+ ALL|Participants with blast phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL) who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
452989|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
452990|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
452991|NCT00860535|E1|Reported Event|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care.
452992|NCT00860470|B3|Baseline|Total|Total of all reporting groups
452993|NCT00860470|B2|Baseline|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
452994|NCT00860470|B1|Baseline|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
452995|NCT00860470|P2|Participant Flow|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
452996|NCT00860470|P1|Participant Flow|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
452997|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
452998|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
452999|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453000|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453001|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453002|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453003|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453004|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453005|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453006|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453007|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453008|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453009|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453010|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453011|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453012|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453013|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453014|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453015|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453016|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453017|NCT00860470|E2|Reported Event|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453018|NCT00860470|E1|Reported Event|Iron (27 mg) and Folic Acid (600 ug)|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
453019|NCT00860457|B1|Baseline|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
453020|NCT00860457|P1|Participant Flow|Chemotherapy|Fludarabine/Rituximab followed by Lenalidomide
453021|NCT00860457|O1|Outcome|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
453022|NCT00860457|E1|Reported Event|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
453023|NCT00860405|B3|Baseline|Total|Total of all reporting groups
453024|NCT00860405|B2|Baseline|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453025|NCT00860405|B1|Baseline|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453026|NCT00860405|P2|Participant Flow|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453027|NCT00860405|P1|Participant Flow|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453028|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453029|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453030|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453031|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453032|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453033|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453034|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453035|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453036|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453037|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453038|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453039|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453040|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453041|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453042|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453043|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453044|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
453045|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
453052|NCT00860314|P1|Participant Flow|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
453053|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
453054|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
453055|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
453056|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
453057|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
453058|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
453059|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
453060|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
453061|NCT00860314|E2|Reported Event|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
453062|NCT00860314|E1|Reported Event|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
453063|NCT00860262|B4|Baseline|Total|Total of all reporting groups
453064|NCT00860262|B3|Baseline|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453065|NCT00860262|B2|Baseline|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453066|NCT00860262|B1|Baseline|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453067|NCT00860262|P3|Participant Flow|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453068|NCT00860262|P2|Participant Flow|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453069|NCT00860262|P1|Participant Flow|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453070|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453071|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453072|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453073|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453074|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453075|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453076|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453077|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453078|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453079|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453080|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453081|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453082|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453083|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453084|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453085|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453086|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453087|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453088|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453089|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453090|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453091|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453092|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453093|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453094|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453095|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453096|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453097|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453098|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453099|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453100|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453101|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453102|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453103|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453104|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453105|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453106|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453107|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453108|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453109|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453110|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453111|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453112|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453113|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453114|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453115|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453116|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453117|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453118|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453119|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453120|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453123|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453124|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453125|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453126|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453127|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453128|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453129|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453130|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453131|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453132|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453133|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453134|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453135|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453136|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453137|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453138|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453139|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453140|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453141|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453142|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453143|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453144|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453145|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453146|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453147|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453148|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453149|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453150|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453151|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453152|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453153|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453154|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453155|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453156|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453157|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453158|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453159|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453160|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453161|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453162|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453163|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
453164|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453165|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
453166|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453167|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453168|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453169|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453170|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453171|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453172|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453173|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453174|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453175|NCT00860262|E3|Reported Event|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
453176|NCT00860262|E2|Reported Event|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
453177|NCT00860262|E1|Reported Event|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
453178|NCT00860249|B4|Baseline|Total|Total of all reporting groups
453179|NCT00860249|B3|Baseline|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
453180|NCT00860249|B2|Baseline|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
453181|NCT00860249|B1|Baseline|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
453182|NCT00860249|P3|Participant Flow|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
453267|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453183|NCT00860249|P2|Participant Flow|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
453184|NCT00860249|P1|Participant Flow|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
453185|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
453186|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
453187|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
453188|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
453189|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
453190|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
453191|NCT00860249|E3|Reported Event|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
453192|NCT00860249|E2|Reported Event|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
453193|NCT00860249|E1|Reported Event|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
453194|NCT00860171|B1|Baseline|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
453195|NCT00860171|P1|Participant Flow|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
453196|NCT00860171|O1|Outcome|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
453197|NCT00860171|O1|Outcome|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
453198|NCT00860171|O1|Outcome|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
453199|NCT00860171|O1|Outcome|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
453200|NCT00860171|E1|Reported Event|Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)|"Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.~Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter~Iodine I 131 Monoclonal Antibody BC8: Given IV~Laboratory Biomarker Analysis: Correlative studies"
453201|NCT00860158|B1|Baseline|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453202|NCT00860158|P1|Participant Flow|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453203|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453204|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453205|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453206|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453207|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453208|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453209|NCT00860158|E1|Reported Event|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
453210|NCT00860067|B4|Baseline|Total|Total of all reporting groups
453211|NCT00860067|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453212|NCT00860067|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453213|NCT00860067|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453214|NCT00860067|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453215|NCT00860067|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453291|NCT00859950|O2|Outcome|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
453766|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
453216|NCT00860067|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453217|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453218|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453219|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453220|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453221|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453222|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453223|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453224|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453225|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453226|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453227|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453228|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453229|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453230|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453231|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453232|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453233|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453318|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
453767|NCT00858442|O1|Outcome|Without PRP|Patients did not received plasma enrich platelets
453234|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453235|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453236|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453237|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453238|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453239|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453240|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453241|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453242|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453243|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453244|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453245|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453246|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453247|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453248|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453249|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453250|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453251|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453252|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453253|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453254|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453255|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453256|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453257|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453258|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453259|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453260|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453261|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453262|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453263|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453264|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453265|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453266|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453268|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
453269|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
453270|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453271|NCT00860067|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
453272|NCT00860067|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
453273|NCT00860028|B3|Baseline|Total|Total of all reporting groups
453274|NCT00860028|B2|Baseline|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
453275|NCT00860028|B1|Baseline|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
453276|NCT00860028|P2|Participant Flow|Placebo Pretreatment/Varenicline Treatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
453277|NCT00860028|P1|Participant Flow|Varenicline Pretreatment/Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
453278|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date
453279|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
453280|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
453281|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date.
453282|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
453283|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
453284|NCT00860028|E2|Reported Event|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
453285|NCT00860028|E1|Reported Event|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
453286|NCT00859950|B3|Baseline|Total|Total of all reporting groups
453287|NCT00859950|B2|Baseline|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
453288|NCT00859950|B1|Baseline|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
453289|NCT00859950|P2|Participant Flow|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
453290|NCT00859950|P1|Participant Flow|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
453292|NCT00859950|O1|Outcome|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
453293|NCT00859950|E2|Reported Event|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw.~Serious and Other [Not Including Serious] Adverse Events were not observed."
453294|NCT00859950|E1|Reported Event|Normal Control|"Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.~Serious and Other [Not Including Serious] Adverse Events were not observed."
453295|NCT00859937|B3|Baseline|Total|Total of all reporting groups
453296|NCT00859937|B2|Baseline|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453297|NCT00859937|B1|Baseline|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453298|NCT00859937|P2|Participant Flow|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453299|NCT00859937|P1|Participant Flow|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453300|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453301|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453302|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453303|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453304|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453305|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453306|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453307|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453308|NCT00859937|E2|Reported Event|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453309|NCT00859937|E1|Reported Event|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
453310|NCT00859898|B4|Baseline|Total|Total of all reporting groups
453311|NCT00859898|B3|Baseline|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453312|NCT00859898|B2|Baseline|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
453313|NCT00859898|B1|Baseline|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453314|NCT00859898|P3|Participant Flow|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453315|NCT00859898|P2|Participant Flow|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.~Placebo: Metformin hydrochloride (HCl) Modified Release matching placebo tablets, once daily, 24 weeks."
453316|NCT00859898|P1|Participant Flow|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453317|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453319|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453320|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453321|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
453322|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453323|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453324|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
453325|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453326|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453327|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
453328|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453329|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453330|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
453331|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453332|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453333|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
453334|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453335|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453336|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
453337|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453338|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453339|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
453340|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453341|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453342|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
453343|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453344|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453345|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
453346|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453347|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453348|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
453349|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453350|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453351|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
453352|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453353|NCT00859898|E3|Reported Event|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
453354|NCT00859898|E2|Reported Event|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
453355|NCT00859898|E1|Reported Event|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
453429|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
453356|NCT00859833|B1|Baseline|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
453357|NCT00859833|P1|Participant Flow|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.
453358|NCT00859833|O2|Outcome|Regadenoson|Regadenoson 0.5 mg i.v. bolus.
453359|NCT00859833|O1|Outcome|Adenosine|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes).
453360|NCT00859833|E1|Reported Event|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
453361|NCT00859651|B3|Baseline|Total|Total of all reporting groups
453362|NCT00859651|B2|Baseline|Cholecalciferol 30,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
453363|NCT00859651|B1|Baseline|Cholecalciferol 20,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
453364|NCT00859651|P2|Participant Flow|Cholecalciferol 30,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
453365|NCT00859651|P1|Participant Flow|Cholecalciferol 20,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
453366|NCT00859651|O2|Outcome|Cholecalciferol 30,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
453367|NCT00859651|O1|Outcome|Cholecalciferol 20,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
453368|NCT00859651|O2|Outcome|Cholecalciferol 30,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
453369|NCT00859651|O1|Outcome|Cholecalciferol 20,000 IU Group|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
453370|NCT00859651|E2|Reported Event|Cholecalciferol 30,000 IU|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.
453371|NCT00859651|E1|Reported Event|Cholecalciferol 20,000 IU|Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.
453372|NCT00859638|B3|Baseline|Total|Total of all reporting groups
453373|NCT00859638|B2|Baseline|Case Matched Controls|Usual care in primary health care.
453374|NCT00859638|B1|Baseline|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
453375|NCT00859638|P2|Participant Flow|Case Matched Controls|Usual care in primary health care.
453376|NCT00859638|P1|Participant Flow|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
453377|NCT00859638|O2|Outcome|Case Matched Controls|Usual care in primary health care.
453378|NCT00859638|O1|Outcome|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
453379|NCT00859638|E2|Reported Event|Case Matched Controls|Usual care in primary health care.
453380|NCT00859638|E1|Reported Event|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
453381|NCT00859586|B1|Baseline|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
453382|NCT00859586|P1|Participant Flow|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
453383|NCT00859586|O1|Outcome|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
453430|NCT00859469|E1|Reported Event|Oxaliplatin and Gemcitabine|
453431|NCT00859430|B3|Baseline|Total|Total of all reporting groups
453432|NCT00859430|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
453768|NCT00858442|E2|Reported Event|With PRP|Patients received plasma enriched platelets
453384|NCT00859586|E1|Reported Event|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
453385|NCT00859573|B3|Baseline|Total|Total of all reporting groups
453386|NCT00859573|B2|Baseline|Placebo|Two placebo tablets orally once daily
453387|NCT00859573|B1|Baseline|Modafinil|Modafinil 400mg orally once daily
453388|NCT00859573|P2|Participant Flow|Placebo|Two placebo tablets orally once daily
453389|NCT00859573|P1|Participant Flow|Modafinil|Modafinil 400mg orally once daily
453390|NCT00859573|O2|Outcome|Modafinil|Modafinil 400mg orally daily
453391|NCT00859573|O1|Outcome|Placebo|Participants received 2 capsules placebo orally daily
453392|NCT00859573|E2|Reported Event|Placebo|Two placebo tablets orally once daily
453393|NCT00859573|E1|Reported Event|Modafinil|Modafinil 400mg orally once daily
453394|NCT00859547|B1|Baseline|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453395|NCT00859547|P1|Participant Flow|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453396|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453397|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453398|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453399|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453400|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453401|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453402|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453403|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
453404|NCT00859547|E1|Reported Event|TOTAL|
453405|NCT00859521|B3|Baseline|Total|Total of all reporting groups
453406|NCT00859521|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
453407|NCT00859521|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
453408|NCT00859521|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
453409|NCT00859521|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
453410|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
453411|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
453412|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
453413|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
453414|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
453415|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
453416|NCT00859508|B3|Baseline|Total|Total of all reporting groups
453417|NCT00859508|B2|Baseline|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
453418|NCT00859508|B1|Baseline|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
453419|NCT00859508|P2|Participant Flow|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
453420|NCT00859508|P1|Participant Flow|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
453421|NCT00859508|O2|Outcome|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
453422|NCT00859508|O1|Outcome|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
453423|NCT00859508|E2|Reported Event|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
453424|NCT00859508|E1|Reported Event|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
453425|NCT00859469|B1|Baseline|Oxaliplatin and Gemcitabine|
453426|NCT00859469|P1|Participant Flow|Oxaliplatin and Gemcitabine|
453427|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
453428|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
453433|NCT00859430|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
453434|NCT00859430|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
453435|NCT00859430|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
453436|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
453437|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
453438|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
453439|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
453440|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
453441|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
453442|NCT00859339|B1|Baseline|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453443|NCT00859339|P1|Participant Flow|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453444|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453445|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453446|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453447|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453448|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453449|NCT00859339|E1|Reported Event|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
453450|NCT00859313|B1|Baseline|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
453451|NCT00859313|P1|Participant Flow|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
453452|NCT00859313|O1|Outcome|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
453453|NCT00859313|E1|Reported Event|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
453454|NCT00859222|B4|Baseline|Total|Total of all reporting groups
453455|NCT00859222|B3|Baseline|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453456|NCT00859222|B2|Baseline|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453457|NCT00859222|B1|Baseline|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
453458|NCT00859222|P5|Participant Flow|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453505|NCT00859131|E2|Reported Event|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
457241|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
453459|NCT00859222|P4|Participant Flow|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453460|NCT00859222|P3|Participant Flow|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453461|NCT00859222|P2|Participant Flow|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453462|NCT00859222|P1|Participant Flow|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
453463|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
453464|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453465|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453466|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
453467|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
453468|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453469|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453470|NCT00859222|O5|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453471|NCT00859222|O4|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453472|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453473|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453474|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
453475|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453476|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453575|NCT00859027|P2|Participant Flow|Calcium and Vitamin D Daily (Placebo Group)|Pts received placebo risedronate + calcium and Vit D.
453477|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453478|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453479|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
453480|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
453481|NCT00859222|E5|Reported Event|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453482|NCT00859222|E4|Reported Event|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453483|NCT00859222|E3|Reported Event|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453484|NCT00859222|E2|Reported Event|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
453485|NCT00859222|E1|Reported Event|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
453486|NCT00859131|B3|Baseline|Total|Total of all reporting groups
453487|NCT00859131|B2|Baseline|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453488|NCT00859131|B1|Baseline|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453489|NCT00859131|P2|Participant Flow|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453490|NCT00859131|P1|Participant Flow|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453491|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453492|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453493|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453494|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453495|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453496|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453497|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453498|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453499|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453500|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453501|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453502|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453503|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
453504|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453506|NCT00859131|E1|Reported Event|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
453507|NCT00859053|B5|Baseline|Total|Total of all reporting groups
453508|NCT00859053|B4|Baseline|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453509|NCT00859053|B3|Baseline|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453510|NCT00859053|B2|Baseline|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453511|NCT00859053|B1|Baseline|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453512|NCT00859053|P4|Participant Flow|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453513|NCT00859053|P3|Participant Flow|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453514|NCT00859053|P2|Participant Flow|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453515|NCT00859053|P1|Participant Flow|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 milligrams (mg) (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453516|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453517|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453518|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453519|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453520|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453521|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453522|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453523|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453524|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453525|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453526|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453527|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453528|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453529|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453530|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453531|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453532|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453533|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453534|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453535|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453536|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453537|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453538|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453539|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453540|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453541|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453542|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453543|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453544|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453545|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453546|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453547|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453548|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453549|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453550|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453551|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453552|NCT00859053|E4|Reported Event|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453553|NCT00859053|E3|Reported Event|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453554|NCT00859053|E2|Reported Event|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453555|NCT00859053|E1|Reported Event|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
453556|NCT00859040|B3|Baseline|Total|Total of all reporting groups
453557|NCT00859040|B2|Baseline|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453558|NCT00859040|B1|Baseline|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453559|NCT00859040|P2|Participant Flow|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453560|NCT00859040|P1|Participant Flow|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453561|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453562|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453563|NCT00859040|O1|Outcome|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
453564|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453565|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453566|NCT00859040|O1|Outcome|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
453567|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453568|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453569|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453570|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
453571|NCT00859040|E1|Reported Event|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
453572|NCT00859027|B3|Baseline|Total|Total of all reporting groups
453573|NCT00859027|B2|Baseline|Calcium and Vitamin D|
453574|NCT00859027|B1|Baseline|Risedronate Plus Calcium and Vit D|
453576|NCT00859027|P1|Participant Flow|Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily|"Pts receiving LHRH-agonists for prostate cancer received active risedronate.~They also received daily calcium + Vit D"
453577|NCT00859027|O2|Outcome|Calcium and Vitamin D Daily (Placebo Group)|
453578|NCT00859027|O1|Outcome|Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily|
453579|NCT00859027|O2|Outcome|Calcium and Vitamin D Daily (Placebo Group)|
453580|NCT00859027|O1|Outcome|Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily|
453581|NCT00859027|E2|Reported Event|Risedronate|Particiapnts given 35 mg by mouth every week
453582|NCT00859027|E1|Reported Event|Calcium and Vitamin D|
453583|NCT00859014|B1|Baseline|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
453584|NCT00859014|P1|Participant Flow|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
453585|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
453586|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
453587|NCT00859014|E1|Reported Event|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
453588|NCT00858962|B1|Baseline|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
453589|NCT00858962|P1|Participant Flow|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
453590|NCT00858962|O1|Outcome|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
453591|NCT00858962|E1|Reported Event|Bup/Ral|HIV negative subjects currently enrolled in Buprenorphine maintenance therapy on a stable dose of BUP for at least 3 weeks were admitted to the HRU for PK sampling at intervals over a 24 hour period. Subjects then received RAL and BUP co-administration for a minimum of 4 days after which a second series of blood draws at intervals over a 24 hour period were conducted.
453592|NCT00858858|B1|Baseline|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
453593|NCT00858858|P1|Participant Flow|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
453594|NCT00858858|O1|Outcome|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
453595|NCT00858858|E1|Reported Event|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
453596|NCT00858845|B3|Baseline|Total|Total of all reporting groups
453597|NCT00858845|B2|Baseline|Placebo Patch|Participants were assigned to wear a matching placebo patch (0.1 mg/weekly) for a treatment period of 3 months.
453598|NCT00858845|B1|Baseline|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
453599|NCT00858845|P2|Participant Flow|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
453600|NCT00858845|P1|Participant Flow|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
453601|NCT00858845|O2|Outcome|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
453602|NCT00858845|O1|Outcome|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
453603|NCT00858845|O2|Outcome|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
453604|NCT00858845|O1|Outcome|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
453605|NCT00858845|O2|Outcome|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
453606|NCT00858845|O1|Outcome|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
453607|NCT00858845|E2|Reported Event|Placebo|Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
453608|NCT00858845|E1|Reported Event|Clonidine Patch|Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
453609|NCT00858832|B3|Baseline|Total|Total of all reporting groups
453610|NCT00858832|B2|Baseline|No Methergine|
453611|NCT00858832|B1|Baseline|Methergine|
453612|NCT00858832|P2|Participant Flow|No Treatment|Participants received no intervention (no treatment).
453613|NCT00858832|P1|Participant Flow|Methergine|Participants received Methergine 0.2mg orally every 6 hours for 2 days
453614|NCT00858832|O2|Outcome|No Methergine|
453615|NCT00858832|O1|Outcome|Methergine|
453616|NCT00858832|E2|Reported Event|No Methergine|
453617|NCT00858832|E1|Reported Event|Methergine|
453618|NCT00858780|B1|Baseline|Entire Study Population|Includes all participants who were enrolled in this study.
453619|NCT00858780|P5|Participant Flow|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
453620|NCT00858780|P4|Participant Flow|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453621|NCT00858780|P3|Participant Flow|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453622|NCT00858780|P2|Participant Flow|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453623|NCT00858780|P1|Participant Flow|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
453624|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453625|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453626|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453720|NCT00858637|O2|Outcome|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mgof Simvastatin / day as titrated
453769|NCT00858442|E1|Reported Event|Without PRP|Patients did not receive plasma enriched platelets
453627|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453628|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453629|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453630|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453631|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453632|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453633|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453634|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453635|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453636|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453637|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453638|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453639|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453640|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453641|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453642|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453643|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453644|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453645|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453646|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453647|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453648|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453649|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453650|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453651|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453652|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453653|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453654|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453655|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453656|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453657|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453658|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453659|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453660|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453661|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453662|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453663|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453664|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453665|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453666|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453667|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453668|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453669|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453670|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453671|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453672|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453673|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453674|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453675|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453676|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453677|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453678|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453679|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453680|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453681|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453682|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453683|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453684|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453685|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453686|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453687|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453688|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453689|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453690|NCT00858780|E5|Reported Event|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
453691|NCT00858780|E4|Reported Event|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453721|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
453770|NCT00858403|B1|Baseline|Treatment With Dasatinib|
453692|NCT00858780|E3|Reported Event|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
453693|NCT00858780|E2|Reported Event|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
453694|NCT00858780|E1|Reported Event|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
453695|NCT00858702|B3|Baseline|Total|Total of all reporting groups
453696|NCT00858702|B2|Baseline|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
453697|NCT00858702|B1|Baseline|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
453698|NCT00858702|P2|Participant Flow|Olmesartan Medoxomil Tablets and a Diuretic Tablet|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
453699|NCT00858702|P1|Participant Flow|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
453700|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks
453701|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
453702|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
453703|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks
453704|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
453705|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
453706|NCT00858689|B1|Baseline|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
453707|NCT00858689|P1|Participant Flow|Minocyline 50 mg or 100 mg PO BID|open label, single arm study of minocyline 50 mg or 100 mg PO BID
453708|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
453709|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
453710|NCT00858689|E1|Reported Event|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
453711|NCT00858637|B3|Baseline|Total|Total of all reporting groups
453712|NCT00858637|B2|Baseline|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
453713|NCT00858637|B1|Baseline|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
453714|NCT00858637|P6|Participant Flow|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453715|NCT00858637|P5|Participant Flow|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453716|NCT00858637|P4|Participant Flow|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
453717|NCT00858637|P3|Participant Flow|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453718|NCT00858637|P2|Participant Flow|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453719|NCT00858637|P1|Participant Flow|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
453722|NCT00858637|O4|Outcome|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453723|NCT00858637|O3|Outcome|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453724|NCT00858637|O2|Outcome|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453725|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
453726|NCT00858637|E2|Reported Event|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
453727|NCT00858637|E1|Reported Event|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
453728|NCT00858507|B3|Baseline|Total|Total of all reporting groups
453729|NCT00858507|B2|Baseline|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
453730|NCT00858507|B1|Baseline|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
453731|NCT00858507|P2|Participant Flow|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
453732|NCT00858507|P1|Participant Flow|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
453733|NCT00858507|O2|Outcome|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
453734|NCT00858507|O1|Outcome|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
453735|NCT00858507|E2|Reported Event|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
453736|NCT00858507|E1|Reported Event|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
453737|NCT00858494|B1|Baseline|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
453738|NCT00858494|P1|Participant Flow|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
453739|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
453740|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
453741|NCT00858494|E1|Reported Event|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
453742|NCT00858468|B3|Baseline|Total|Total of all reporting groups
453743|NCT00858468|B2|Baseline|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
453744|NCT00858468|B1|Baseline|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
453745|NCT00858468|P2|Participant Flow|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
453746|NCT00858468|P1|Participant Flow|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
453747|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
453748|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
453749|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
453750|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
453751|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
453752|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
453753|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
453754|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
453755|NCT00858468|E2|Reported Event|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
453756|NCT00858468|E1|Reported Event|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
453757|NCT00858442|B3|Baseline|Total|Total of all reporting groups
453758|NCT00858442|B2|Baseline|With PRP|Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010.
453759|NCT00858442|B1|Baseline|Without PRP|Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010.
453760|NCT00858442|P2|Participant Flow|With PRP|4 cc of PRP is evenly distributed before the dermo-epidermic draft.
453761|NCT00858442|P1|Participant Flow|Without PRP|This arm did not receive any intervention
453762|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
453763|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
453764|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
453765|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
453781|NCT00858390|B2|Baseline|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
453782|NCT00858390|B1|Baseline|1 Standard Care|18 organ donors receiving standard care
453783|NCT00858390|P2|Participant Flow|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
453784|NCT00858390|P1|Participant Flow|1 Standard Care|18 organ donors receiving standard care
453785|NCT00858390|O2|Outcome|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
453786|NCT00858390|O1|Outcome|1 Standard Care|18 organ donors receiving standard care
453787|NCT00858390|E2|Reported Event|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
453788|NCT00858390|E1|Reported Event|1 Standard Care|18 organ donors receiving standard care
453789|NCT00858247|B3|Baseline|Total|Total of all reporting groups
453790|NCT00858247|B2|Baseline|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily
453791|NCT00858247|B1|Baseline|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily
453792|NCT00858247|P2|Participant Flow|Vitamin D3-high Dose|"Vitamin D3 2000 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
453793|NCT00858247|P1|Participant Flow|Vitamin D3-low Dose|"Vitamin D3 400 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
453794|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
453795|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
453796|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
453797|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
453798|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
453799|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
453800|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
453801|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
453802|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
453803|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
453804|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
453805|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
453806|NCT00858247|E2|Reported Event|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
453807|NCT00858247|E1|Reported Event|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
453808|NCT00858208|B1|Baseline|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453809|NCT00858208|P1|Participant Flow|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453810|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453811|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453812|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453813|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453814|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453815|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453816|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453817|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453818|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
454404|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
453819|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453820|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453821|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453822|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453823|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453824|NCT00858208|E1|Reported Event|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
453825|NCT00858143|B1|Baseline|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453826|NCT00858143|P1|Participant Flow|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453827|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453828|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453829|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453830|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453831|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453832|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453833|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453834|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453835|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453836|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453837|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453838|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453839|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453840|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453841|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453842|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453843|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453844|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453845|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453846|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453847|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453848|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453849|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453850|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453851|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453852|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453853|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453854|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453855|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453856|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453857|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453858|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453859|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453860|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453861|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453862|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453863|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453864|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453865|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453866|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453867|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453868|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453869|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453870|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453871|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453872|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453873|NCT00858143|E1|Reported Event|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
453874|NCT00858130|B1|Baseline|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453875|NCT00858130|P1|Participant Flow|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~Veinoplus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453876|NCT00858130|O1|Outcome|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~Veinoplus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453877|NCT00858130|O1|Outcome|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~Veinoplus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453878|NCT00858130|O1|Outcome|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453879|NCT00858130|O1|Outcome|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453880|NCT00858130|O1|Outcome|VeinoPlus|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The Veinoplus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453881|NCT00858130|E1|Reported Event|VeinoPlus Experimental Arm|"Every subject enrolled in study will be in this experimental arm. VeinoPlus device will be used by all enrolled subjects.~VeinoPlus: The VeinoPlus® device electrically stimulates leg muscles via motor nerves, causing calf muscle contractions. The two electrodes are placed on the central part of the calf muscle on the back of the legs, and once the device is turned on, the length of treatment is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations mid-cycle if desired. Subjects will use the device however they see fit for 2 months."
453882|NCT00858013|B3|Baseline|Total|Total of all reporting groups
453883|NCT00858013|B2|Baseline|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
453884|NCT00858013|B1|Baseline|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453885|NCT00858013|P2|Participant Flow|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
453886|NCT00858013|P1|Participant Flow|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453887|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
453888|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453889|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
453890|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453891|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
453892|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453893|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
457242|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
453894|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453895|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
453896|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453897|NCT00858013|E2|Reported Event|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
453898|NCT00858013|E1|Reported Event|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
453899|NCT00857961|B1|Baseline|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
453900|NCT00857961|P1|Participant Flow|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
453901|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453902|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453903|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453904|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453905|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453906|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453907|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453908|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453909|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453910|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453911|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453912|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453913|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453914|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453915|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453916|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453917|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453918|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453919|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453920|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453921|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453922|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453923|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453924|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453925|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453926|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453927|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453928|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453929|NCT00857961|E4|Reported Event|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
453930|NCT00857961|E3|Reported Event|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453931|NCT00857961|E2|Reported Event|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
453932|NCT00857961|E1|Reported Event|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
453933|NCT00857948|B5|Baseline|Total|Total of all reporting groups
453934|NCT00857948|B4|Baseline|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
453935|NCT00857948|B3|Baseline|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
453936|NCT00857948|B2|Baseline|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
453937|NCT00857948|B1|Baseline|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
453938|NCT00857948|P4|Participant Flow|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
453939|NCT00857948|P3|Participant Flow|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
453940|NCT00857948|P2|Participant Flow|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
453941|NCT00857948|P1|Participant Flow|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
453942|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
453943|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
453944|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
453945|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
453946|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
453947|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
453948|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
453949|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
453950|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
453951|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
453952|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
453953|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
453954|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
453955|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
453956|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
453957|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
453958|NCT00857948|E4|Reported Event|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
453959|NCT00857948|E3|Reported Event|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
453960|NCT00857948|E2|Reported Event|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
453961|NCT00857948|E1|Reported Event|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
453962|NCT00857896|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453963|NCT00857896|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453964|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453965|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453966|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453967|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453968|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453969|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453970|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453971|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
453972|NCT00857896|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 8 mg tablet QD anytime during the study
453973|NCT00857896|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet QD anytime during the study
453974|NCT00857857|B1|Baseline|Overall Study|Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 mg, 1 mg, 3 mg OD, active control (fluticasone propionate 0.25mg BID) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as MDPI. GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
453989|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
457243|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
453975|NCT00857857|P1|Participant Flow|Overall Study|Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 milligram (mg), 1 mg, 3 mg once daily (OD), active control (fluticasone propionate 0.25 mg bi-daily [BID]) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as multi-dose powder inhaler (MDPI). GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
453976|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
453977|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453978|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453979|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
453980|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
453981|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
453982|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453983|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453984|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
453985|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
453986|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
453987|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453988|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453990|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
453991|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
453992|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453993|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453994|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
453995|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
453996|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
453997|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453998|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
453999|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454000|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454001|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454002|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454003|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454210|NCT00857623|E1|Reported Event|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454004|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454005|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454006|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454007|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454008|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454009|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454010|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454011|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454012|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454013|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454014|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454015|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454016|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454017|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454211|NCT00857584|B3|Baseline|Total|Total of all reporting groups
457244|NCT00852917|O4|Outcome|4: Placebo|
454018|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454019|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454020|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454021|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454022|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454023|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454024|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454025|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454026|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454027|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454028|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454029|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454030|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454031|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454405|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454032|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454033|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454034|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454035|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454036|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454037|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454038|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454039|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454040|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454041|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454042|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454043|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454044|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454045|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454212|NCT00857584|B2|Baseline|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454046|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454047|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454048|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454049|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454050|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454051|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454052|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454053|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454054|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454055|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454056|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454057|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454058|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454059|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454117|NCT00857818|B2|Baseline|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454060|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454061|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454062|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454063|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454064|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454065|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454066|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454067|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454068|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454069|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454070|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454071|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454072|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454073|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454151|NCT00857766|B3|Baseline|Total|Total of all reporting groups
454074|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454075|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454076|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454077|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454078|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454079|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454080|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454081|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454082|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454083|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454084|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454085|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454086|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454087|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454207|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454088|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454089|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454090|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454091|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454092|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454093|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454094|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454095|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454096|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454097|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454098|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454099|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454100|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454101|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454208|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454102|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454103|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454104|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454105|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454106|NCT00857857|O5|Outcome|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454107|NCT00857857|O4|Outcome|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454108|NCT00857857|O3|Outcome|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454109|NCT00857857|O2|Outcome|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454110|NCT00857857|O1|Outcome|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454111|NCT00857857|E5|Reported Event|Fluticasone Propionate 0.25 mg BID|Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
454112|NCT00857857|E4|Reported Event|GW870086 3 mg OD|Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454113|NCT00857857|E3|Reported Event|GW870086 1 mg OD|Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.
454114|NCT00857857|E2|Reported Event|GW870086 0.25 mg OD|Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.
454115|NCT00857857|E1|Reported Event|Placebo|Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
454116|NCT00857818|B3|Baseline|Total|Total of all reporting groups
454118|NCT00857818|B1|Baseline|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454119|NCT00857818|P2|Participant Flow|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454120|NCT00857818|P1|Participant Flow|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454121|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454122|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454123|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454124|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454125|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454126|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454127|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454128|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454129|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454130|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454131|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454132|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454133|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454134|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454135|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454136|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454137|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454138|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454139|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454140|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454141|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454142|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454143|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454144|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454145|NCT00857818|E2|Reported Event|CONTROL GROUP|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
454146|NCT00857818|E1|Reported Event|ARIPIPRAZOLE|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
454147|NCT00857792|B1|Baseline|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
454148|NCT00857792|P1|Participant Flow|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
454149|NCT00857792|O1|Outcome|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
454150|NCT00857792|E1|Reported Event|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
454152|NCT00857766|B2|Baseline|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454153|NCT00857766|B1|Baseline|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454154|NCT00857766|P2|Participant Flow|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454155|NCT00857766|P1|Participant Flow|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454156|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454157|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454158|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454159|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454160|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454161|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454162|NCT00857766|E2|Reported Event|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454163|NCT00857766|E1|Reported Event|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
454164|NCT00857714|B1|Baseline|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
454165|NCT00857714|P1|Participant Flow|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
454166|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
454167|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
454168|NCT00857714|E1|Reported Event|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
454169|NCT00857649|B3|Baseline|Total|Total of all reporting groups
454170|NCT00857649|B2|Baseline|Placebo|Oral Tablets Once Daily
454171|NCT00857649|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
454172|NCT00857649|P2|Participant Flow|Placebo|Oral Tablets Once Daily
454173|NCT00857649|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
454174|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
454175|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454176|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
454177|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454178|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
454179|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454180|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
454181|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454182|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
454183|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454184|NCT00857649|E2|Reported Event|Placebo|Oral Tablets Once Daily
454185|NCT00857649|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
454186|NCT00857623|B3|Baseline|Total|Total of all reporting groups
454187|NCT00857623|B2|Baseline|Placebo|Capsule, once daily
454188|NCT00857623|B1|Baseline|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454189|NCT00857623|P2|Participant Flow|Placebo|Capsule, once daily
454190|NCT00857623|P1|Participant Flow|AZD2066|Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
454191|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454192|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454193|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454194|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454195|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454196|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454197|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454198|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454199|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454200|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454201|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454202|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454203|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454204|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454205|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
454206|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
454213|NCT00857584|B1|Baseline|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454214|NCT00857584|P2|Participant Flow|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454215|NCT00857584|P1|Participant Flow|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454216|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454217|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454218|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454219|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454220|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454221|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454222|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454223|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454224|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454225|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454226|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454227|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454228|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454229|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454230|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454231|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454232|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454233|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454234|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454235|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454236|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454237|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454238|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454239|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454240|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454241|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454242|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454243|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454244|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454245|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454246|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454247|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454248|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454370|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
454249|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454250|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454251|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454252|NCT00857584|E2|Reported Event|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
454253|NCT00857584|E1|Reported Event|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
454254|NCT00857545|B3|Baseline|Total|Total of all reporting groups
454255|NCT00857545|B2|Baseline|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454256|NCT00857545|B1|Baseline|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454257|NCT00857545|P2|Participant Flow|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454258|NCT00857545|P1|Participant Flow|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454259|NCT00857545|O2|Outcome|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454260|NCT00857545|O1|Outcome|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454261|NCT00857545|O2|Outcome|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454262|NCT00857545|O1|Outcome|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454263|NCT00857545|O2|Outcome|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454264|NCT00857545|O1|Outcome|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454265|NCT00857545|E2|Reported Event|Non-specific Immunity With OPT-821|Non-specific OPT-821 subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454266|NCT00857545|E1|Reported Event|Polyvalent Antigen-KLH+OPT-821 Vaccine|Polyvalent antigen-KLH + OPT-821 vaccine subcutaneously administered on weeks 1, 2, 3, 7, 11, 23, 35, 47, 59, 71 and 83 for a total of 11 vaccines until disease progression or adverse effects prohibit further treatment. 1 cycle = 1 vaccine
454267|NCT00857532|B1|Baseline|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
454268|NCT00857532|P1|Participant Flow|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
454269|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
454270|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
454271|NCT00857532|O3|Outcome|Subjects With Moderate to Severe Cognitive Impairment|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score 5 and below.
454272|NCT00857532|O2|Outcome|Subjects With Mild Cognitive Deficits|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score between 6 and 8 inclusive.
454273|NCT00857532|O1|Outcome|Subjects With Normal Cognitive Performance|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score greater than or equal to 9.
454274|NCT00857532|E1|Reported Event|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
454275|NCT00857506|B4|Baseline|Total|Total of all reporting groups
454276|NCT00857506|B3|Baseline|Cognitively Normal|
454277|NCT00857506|B2|Baseline|Mild Cognitive Impairment|
454278|NCT00857506|B1|Baseline|Alzheimer's Disease|
454279|NCT00857506|P3|Participant Flow|Cognitively Normal|Cognitively Normal (CN) subjects were recruited from study 18F-AV-45-A05 (NCT00702143). 50 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
454325|NCT00857415|E2|Reported Event|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
454280|NCT00857506|P2|Participant Flow|Mild Cognitive Impairment|Subject's with Mild Cognitive Impairment (MCI) were recruited from study 18F-AV-45-A05 (NCT00702143). 36 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
454281|NCT00857506|P1|Participant Flow|Alzheimer's Disease|Subject's with Alzheimer's Disease were recruited from study 18F-AV-45-A05 (NCT00702143). None of these subjects received additional interventions in study 18F-AV-45-A11.
454282|NCT00857506|O3|Outcome|Cognitively Normal|Subjects with a baseline clinical diagnosis of CN.
454283|NCT00857506|O2|Outcome|Mild Cognitive Impairment|Subjects with a baseline clinical diagnosis of MCI.
454284|NCT00857506|O1|Outcome|Alzheimer's Disease|Subjects with a baseline clinical diagnosis of AD.
454285|NCT00857506|O6|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
454286|NCT00857506|O5|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
454287|NCT00857506|O4|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
454288|NCT00857506|O3|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
454289|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. All assessments were obtained for 57 subjects except for CDR-SOB and ADCS ADL which were obtained for 55 and 56 subjects respectively.
454290|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
454291|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
454292|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
454293|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. 57 subjects were analyzed for change in ADAS-Cog and 55 subjects were analyzed for change in CDR.
454294|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
454295|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
454296|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
454297|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline.
454298|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
454299|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
454300|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
454301|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
454302|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
454303|NCT00857506|E3|Reported Event|Cognitively Normal|
454304|NCT00857506|E2|Reported Event|Mild Cognitive Impairment|
454305|NCT00857506|E1|Reported Event|Alzheimer's Disease|
454306|NCT00857454|B1|Baseline|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454307|NCT00857454|P1|Participant Flow|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454308|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454309|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454310|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454311|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454312|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454313|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454314|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454315|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454316|NCT00857454|E1|Reported Event|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
454317|NCT00857415|B3|Baseline|Total|Total of all reporting groups
454318|NCT00857415|B2|Baseline|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
454319|NCT00857415|B1|Baseline|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
454320|NCT00857415|P2|Participant Flow|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
454321|NCT00857415|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
454322|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
454323|NCT00857415|O1|Outcome|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques
454324|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
454371|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy 0.5 mg on Day 1 (baseline)
454326|NCT00857415|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
454327|NCT00857311|B5|Baseline|Total|Total of all reporting groups
454328|NCT00857311|B4|Baseline|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
454329|NCT00857311|B3|Baseline|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
454330|NCT00857311|B2|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
454331|NCT00857311|B1|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
454332|NCT00857311|P4|Participant Flow|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
454333|NCT00857311|P3|Participant Flow|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
454334|NCT00857311|P2|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
454335|NCT00857311|P1|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
454336|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
454337|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
454338|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
454339|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
454340|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
454341|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
454342|NCT00857311|E2|Reported Event|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
454343|NCT00857311|E1|Reported Event|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
454344|NCT00857285|B3|Baseline|Total|Total of all reporting groups
454345|NCT00857285|B2|Baseline|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
454346|NCT00857285|B1|Baseline|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
454347|NCT00857285|P2|Participant Flow|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
454348|NCT00857285|P1|Participant Flow|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
454349|NCT00857285|O2|Outcome|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
454350|NCT00857285|O1|Outcome|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
454351|NCT00857272|B3|Baseline|Total|Total of all reporting groups
454352|NCT00857272|B2|Baseline|HalfLytely With 10mg Bisacodyl|Active Control
454353|NCT00857272|B1|Baseline|HalfLytely With 5mg Bisacodyl|Investigational dose
454354|NCT00857272|P2|Participant Flow|HalfLytely With 10mg Bisacodyl|Active Control
454355|NCT00857272|P1|Participant Flow|HalfLytely With 5mg Bisacodyl|Investigational dose
454356|NCT00857272|O2|Outcome|HalfLytely With 10mg Bisacodyl|Active Control
454357|NCT00857272|O1|Outcome|HalfLytely With 5mg Bisacodyl|Investigational dose
454358|NCT00857272|E2|Reported Event|HalfLytely With 10mg Bisacodyl|Active Control
454359|NCT00857272|E1|Reported Event|HalfLytely With 5mg Bisacodyl|Investigational dose
454360|NCT00857259|B4|Baseline|Total|Total of all reporting groups
454361|NCT00857259|B3|Baseline|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
454362|NCT00857259|B2|Baseline|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
454363|NCT00857259|B1|Baseline|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
454364|NCT00857259|P3|Participant Flow|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
454365|NCT00857259|P2|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
454366|NCT00857259|P1|Participant Flow|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
454367|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
454368|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (Baseline)
454369|NCT00857259|O1|Outcome|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
454372|NCT00857259|O1|Outcome|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
454373|NCT00857259|E2|Reported Event|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
454374|NCT00857259|E1|Reported Event|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
454375|NCT00857246|B1|Baseline|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454376|NCT00857246|P1|Participant Flow|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454377|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454378|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454379|NCT00857246|O1|Outcome|Induction Treatment|Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
454380|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454381|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454382|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment ( starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454383|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454384|NCT00857246|E1|Reported Event|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
454385|NCT00857233|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
454386|NCT00857233|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
454387|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454388|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454389|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454390|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454391|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454392|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
454393|NCT00857233|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
454394|NCT00857220|B1|Baseline|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454395|NCT00857220|P1|Participant Flow|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454396|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454397|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454398|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454399|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454400|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454401|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454402|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454403|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454406|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454407|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454408|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454409|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454410|NCT00857220|E1|Reported Event|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
454411|NCT00856986|B6|Baseline|Total|Total of all reporting groups
454412|NCT00856986|B5|Baseline|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454413|NCT00856986|B4|Baseline|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454414|NCT00856986|B3|Baseline|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454415|NCT00856986|B2|Baseline|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454416|NCT00856986|B1|Baseline|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454417|NCT00856986|P5|Participant Flow|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454418|NCT00856986|P4|Participant Flow|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454419|NCT00856986|P3|Participant Flow|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454420|NCT00856986|P2|Participant Flow|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454421|NCT00856986|P1|Participant Flow|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454422|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454423|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454424|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454425|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454603|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454426|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454427|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454428|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454429|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454430|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454431|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454432|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454433|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454434|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454435|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454436|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454437|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454438|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454439|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454440|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454604|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454605|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454441|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454442|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454443|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454444|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454445|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454446|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454447|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454448|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454449|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454450|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454451|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454452|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454453|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454454|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454455|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454606|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454607|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
457245|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
454456|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454457|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454458|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454459|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454460|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454461|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454462|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454463|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454464|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454465|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454466|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454467|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454468|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454469|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454470|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454608|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454609|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
457246|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
454471|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454472|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454473|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454474|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454475|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454476|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454477|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454478|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454479|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454480|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454481|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454482|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454483|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454484|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454485|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454610|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454611|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454486|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454487|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454488|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454489|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454490|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454491|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454492|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454493|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454494|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454495|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454496|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454497|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454498|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454499|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454500|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454612|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454613|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
457247|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
454501|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454502|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454503|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454504|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454505|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454506|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454507|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454508|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454509|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454510|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454511|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454512|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454513|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454514|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454515|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454614|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454615|NCT00856973|O3|Outcome|Placebo|Placebo once daily
457248|NCT00852917|E4|Reported Event|4: Placebo|
454516|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454517|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454518|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454519|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454520|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454521|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454522|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454523|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454524|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454525|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454526|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454527|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454528|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454529|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454530|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454616|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily
454617|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily
454531|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454532|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454533|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454534|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454535|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454536|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454537|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454538|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454539|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454540|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454541|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454542|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454543|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454544|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454545|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454618|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454619|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
457249|NCT00852917|E3|Reported Event|3: Tramadol Once A Day 300mg|
454546|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454547|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454548|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454549|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454550|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454551|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454552|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454553|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454554|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454555|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454556|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454557|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454558|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454559|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454560|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454620|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454621|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
457250|NCT00852917|E2|Reported Event|2: Tramadol Once A Day 200mg|
454561|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454562|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454563|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454564|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454565|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454566|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454567|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454568|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454569|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454570|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454571|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454572|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454573|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454574|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454575|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454622|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454623|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454576|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454577|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454578|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454579|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454580|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454581|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454582|NCT00856986|E5|Reported Event|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
454583|NCT00856986|E4|Reported Event|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
454584|NCT00856986|E3|Reported Event|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
454585|NCT00856986|E2|Reported Event|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454586|NCT00856986|E1|Reported Event|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
454587|NCT00856973|B4|Baseline|Total|Total of all reporting groups
454588|NCT00856973|B3|Baseline|Placebo|Placebo Once Daily. This included only patients that were randomized (ITT population).
454589|NCT00856973|B2|Baseline|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).
454590|NCT00856973|B1|Baseline|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).
454591|NCT00856973|P3|Participant Flow|Placebo|Placebo 6-17 years
454592|NCT00856973|P2|Participant Flow|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454593|NCT00856973|P1|Participant Flow|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454594|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454595|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454596|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454597|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454598|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454599|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454600|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454601|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454602|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454625|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454626|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454627|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454628|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454629|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454630|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454631|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454632|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454633|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454634|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454635|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454636|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454637|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454638|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454639|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454640|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454641|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454642|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454643|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454644|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454645|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454646|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454647|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454648|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
454649|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454650|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454651|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years
454652|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454653|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454654|NCT00856973|E3|Reported Event|Placebo|Placebo 6-17 years once daily
454655|NCT00856973|E2|Reported Event|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
454656|NCT00856973|E1|Reported Event|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
454657|NCT00856934|B4|Baseline|Total|Total of all reporting groups
454658|NCT00856934|B3|Baseline|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454659|NCT00856934|B2|Baseline|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454660|NCT00856934|B1|Baseline|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
454661|NCT00856934|P3|Participant Flow|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454662|NCT00856934|P2|Participant Flow|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454663|NCT00856934|P1|Participant Flow|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
454664|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454665|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454666|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
454667|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454668|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
454669|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
454670|NCT00856908|B3|Baseline|Total|Total of all reporting groups
454671|NCT00856908|B2|Baseline|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454672|NCT00856908|B1|Baseline|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454673|NCT00856908|P2|Participant Flow|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454674|NCT00856908|P1|Participant Flow|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
455097|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
454675|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454676|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454677|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454678|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454679|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454680|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454681|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454682|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454683|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454684|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454685|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454686|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454687|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454688|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454689|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454690|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454691|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454692|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454693|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454694|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454695|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454696|NCT00856908|E2|Reported Event|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454697|NCT00856908|E1|Reported Event|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
454698|NCT00856843|B3|Baseline|Total|Total of all reporting groups
454699|NCT00856843|B2|Baseline|BLI800|Investigational prep - oral solution, 1 administration
454700|NCT00856843|B1|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454701|NCT00856843|P2|Participant Flow|BLI800|Investigational prep - oral solution, 1 administration
454702|NCT00856843|P1|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454703|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454704|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454705|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454706|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454707|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454708|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454709|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454710|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454711|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454712|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454713|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454714|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454715|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454716|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454717|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454718|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454719|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454720|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454721|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454722|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454723|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454724|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454725|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454726|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454727|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454728|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454729|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
454730|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454731|NCT00856843|E2|Reported Event|BLI800|Investigational prep - oral solution, 1 administration
454732|NCT00856843|E1|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
454733|NCT00856830|B5|Baseline|Total|Total of all reporting groups
454734|NCT00856830|B4|Baseline|Regimen A: Cohort IV Bendamustine 100 -120 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. Bendamustine was given at 100 - 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
454735|NCT00856830|B3|Baseline|Regimen A: Cohort III Bendamustine 120 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 120 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
454736|NCT00856830|B2|Baseline|Regimen A: Cohort II Bendamustine 100 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 100 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
454737|NCT00856830|B1|Baseline|Regimen A: Cohort I Bendamustine 80 mg/m2 (Day 1,2)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at increasing dose levels using a 3 + 3 design. The initial dose of bendamustine was 80 mg/m2 with incremental 20 mg/m2 dose escalation to a maximum of 120 mg/m2. This was repeated every 21 days for a total of 3 cycles.
454738|NCT00856830|P4|Participant Flow|Phase II - Regimen A: Cohort IV (B) 100 -120 mg/m2 (Day 1,2)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendmustine on days 1 and 2 at bendamustine 100-120 mg/m2 (Day 1,2). This was repeated every 21 days for a total of 3 cycles.~Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
454739|NCT00856830|P3|Participant Flow|Phase I - Regimen A: Cohort III (120 mg/M2) - (B)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (120 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles.~Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
454740|NCT00856830|P2|Participant Flow|Phase I - Regimen A: Cohort II 100mg/m2) - (B)|"Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (100 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles.~Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles."
454741|NCT00856830|P1|Participant Flow|Phase I - Regimen A: Cohort I (80 mg/m2) - Bendamustine (B)|Participants were treated with irinotecan at 150 mg/m2 on day 1 followed by bendamustine (80 mg/m2) on days 1 and 2: every 21 days for a total of 3 cycles Participants with either objective response or stable disease after 3 cycles of Regimen A, received Regimen B as a consolidation. Carboplatin AUC6 (Day 1), Etoposide 100mg/m2 (Day 1,2,3) every 21 days for 3 cycles.
454742|NCT00856830|O1|Outcome|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.~This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.~Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.~•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
454761|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454804|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454743|NCT00856830|O1|Outcome|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.~This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.~Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.~•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
454744|NCT00856830|O1|Outcome|Novel Drug Combination|"There is only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.~Bendamustine, Irinotecan, Etoposide/Carboplatin (Novel drug combination): Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.~All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging.~At the end (3 weeks after) of the sixth total round of chemotherapy, subjects will be re-evaluated for response, and will be followed"
454745|NCT00856830|E1|Reported Event|Novel Drug Combination|"This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin.This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.~Novel Drug Combination: This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.~•All subjects will then be given carboplatin (AUC 6) on day 1 and etoposide (100 mg/m2) on days 1, 2 and 3 (Regimen B). They will receive 3 cycles of this regimen every 3 weeks prior to restaging."
454746|NCT00856791|B1|Baseline|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
454747|NCT00856791|P1|Participant Flow|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
454748|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
454749|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
454750|NCT00856791|E1|Reported Event|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
454751|NCT00856778|B1|Baseline|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
454752|NCT00856778|P1|Participant Flow|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454753|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454754|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454755|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454756|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454757|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454758|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454759|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454760|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454803|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454889|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454762|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454763|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454764|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454765|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
454766|NCT00856778|E1|Reported Event|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
454767|NCT00856739|B4|Baseline|Total|Total of all reporting groups
454768|NCT00856739|B3|Baseline|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
454769|NCT00856739|B2|Baseline|Overweight|Body mass index between 25 and 30 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
454770|NCT00856739|B1|Baseline|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
454771|NCT00856739|P3|Participant Flow|Obese|Body mass index over 30 kg/m^2
454772|NCT00856739|P2|Participant Flow|Overweight|Body mass index between 25 and 30 kg/m^2
454773|NCT00856739|P1|Participant Flow|Normal Weight|Body mass index between 18 and 25 kg/m^2
454774|NCT00856739|O4|Outcome|Overweight and Obese Middle Age|Body mass index between 27 and 50 kg/m^2, age between 35 and 60
454775|NCT00856739|O3|Outcome|Normal Weight Middle Age|Body mass index between 18 and 25 kg/m^2, age between 35 and 60
454776|NCT00856739|O2|Outcome|Overweight and Obese Young|Body mass index between 27 and 50 kg/m^2, age between 20 and 35
454777|NCT00856739|O1|Outcome|Normal Weight Young|Body mass index between 18 and 25 kg/m^2, age between 20 and 35
454778|NCT00856739|O2|Outcome|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
454779|NCT00856739|O1|Outcome|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
454780|NCT00856739|E3|Reported Event|Obese|Body mass index between 30 and 50 kg/m^2
454781|NCT00856739|E2|Reported Event|Overweight|Body mass index between 25 and 30 kg/m^2
454782|NCT00856739|E1|Reported Event|Normal Weight|Body mass index between 18 and 25 kg/m^2
454783|NCT00856726|B1|Baseline|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454784|NCT00856726|P1|Participant Flow|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454785|NCT00856726|O1|Outcome|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454786|NCT00856726|O1|Outcome|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454787|NCT00856726|O1|Outcome|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454788|NCT00856726|O1|Outcome|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454789|NCT00856726|O1|Outcome|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454790|NCT00856726|O1|Outcome|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454791|NCT00856726|E1|Reported Event|PTH Infusion|"(1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours~1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours"
454792|NCT00856661|B3|Baseline|Total|Total of all reporting groups
454793|NCT00856661|B2|Baseline|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454794|NCT00856661|B1|Baseline|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454795|NCT00856661|P2|Participant Flow|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454796|NCT00856661|P1|Participant Flow|Desmoteplase|90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454797|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454798|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454799|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454800|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454801|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454802|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
457251|NCT00852917|E1|Reported Event|1: Tramadol Once A Day 100mg|
454805|NCT00856661|E2|Reported Event|Desmoteplase|Desmoteplase: 90 ug/kg, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454806|NCT00856661|E1|Reported Event|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
454807|NCT00856635|B3|Baseline|Total|Total of all reporting groups
454808|NCT00856635|B2|Baseline|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
454809|NCT00856635|B1|Baseline|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
454810|NCT00856635|P2|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
454811|NCT00856635|P1|Participant Flow|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
454812|NCT00856635|O2|Outcome|Placebo|"Participants received placebo subcutaneous injection once a day for up to 6 months.~placebo: injected daily subcutaneously"
454813|NCT00856635|O1|Outcome|Glatiramer Acetate|"Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.~Glatiramer Acetate: 20 mg injected daily subcutaneously"
454814|NCT00856635|O2|Outcome|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
454815|NCT00856635|O1|Outcome|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
454816|NCT00856635|E2|Reported Event|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
454817|NCT00856635|E1|Reported Event|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
454818|NCT00856609|B3|Baseline|Total|Total of all reporting groups
454819|NCT00856609|B2|Baseline|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
454820|NCT00856609|B1|Baseline|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
454821|NCT00856609|P2|Participant Flow|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
454822|NCT00856609|P1|Participant Flow|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
454823|NCT00856609|O2|Outcome|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
454824|NCT00856609|O1|Outcome|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
454825|NCT00856609|O2|Outcome|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
454826|NCT00856609|O1|Outcome|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
454827|NCT00856609|O2|Outcome|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
454828|NCT00856609|O1|Outcome|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
454829|NCT00856609|E2|Reported Event|Placebo|"Twice daily~Metabolic Chamber: The subject stays in the small room~Placebo"
454830|NCT00856609|E1|Reported Event|Exenatide|"10 micrograms subcutaneously twice~Byetta (exenatide): Exenatide is an injectable medication~Weight loss: Because response to weight loss"
454831|NCT00856583|B3|Baseline|Total|Total of all reporting groups
454832|NCT00856583|B2|Baseline|Risperidone|Normally in the range of 2 to 8 mg/day
454833|NCT00856583|B1|Baseline|Sertindole|Normally in the range of 4 to 20 mg/day
454834|NCT00856583|P2|Participant Flow|Risperidone|Normally in the range of 2 to 8 mg/day
454835|NCT00856583|P1|Participant Flow|Sertindole|Normally in the range of 4 to 20 mg/day
454836|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454837|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454838|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454839|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454840|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454841|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454842|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454843|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454844|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454845|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454846|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454847|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454848|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454849|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454850|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454851|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454852|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454853|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454854|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454855|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454856|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454857|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454858|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
454859|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
454860|NCT00856583|E2|Reported Event|Risperidone|Normally in the range of 2 to 8 mg/day
454861|NCT00856583|E1|Reported Event|Sertindole|Normally in the range of 4 to 20 mg/day
454862|NCT00856557|B3|Baseline|Total|Total of all reporting groups
454863|NCT00856557|B2|Baseline|No Intervention|No educational intervention
454890|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454864|NCT00856557|B1|Baseline|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
454865|NCT00856557|P2|Participant Flow|No Intervention|No educational intervention
454866|NCT00856557|P1|Participant Flow|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
454867|NCT00856557|O2|Outcome|No Intervention|No educational intervention
454868|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
454869|NCT00856557|O2|Outcome|No Intervention|No educational intervention
454870|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
454871|NCT00856557|O2|Outcome|No Intervention|No educational intervention
454872|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
454873|NCT00856557|E2|Reported Event|No Intervention|No educational intervention
454874|NCT00856557|E1|Reported Event|Seminar and Practium|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
454875|NCT00856544|B5|Baseline|Total|Total of all reporting groups
454876|NCT00856544|B4|Baseline|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454877|NCT00856544|B3|Baseline|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454878|NCT00856544|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454879|NCT00856544|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454880|NCT00856544|P4|Participant Flow|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454881|NCT00856544|P3|Participant Flow|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454882|NCT00856544|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454883|NCT00856544|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454884|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454885|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454886|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454887|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454888|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454891|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454892|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454893|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454894|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454895|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454896|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454897|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454898|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454899|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454900|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454901|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454902|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454903|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454904|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454905|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454906|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454907|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454908|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454909|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454910|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454911|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454912|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454913|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454914|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454915|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454916|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454917|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454918|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454919|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454920|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454921|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454922|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454923|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454924|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454925|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454926|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454927|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454928|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454929|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454930|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454931|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454932|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454933|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454934|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454935|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454936|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454937|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454938|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454939|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454940|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454941|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454942|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454943|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454944|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454945|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454946|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454947|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454948|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454949|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454950|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454951|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454952|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454953|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454954|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454955|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454956|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454957|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454958|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454959|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454960|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454961|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454962|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454963|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454964|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454965|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454966|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454967|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454968|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454969|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454970|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454971|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454972|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454973|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454974|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454975|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454976|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454977|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454978|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454979|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454980|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454981|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454982|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454983|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454984|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454985|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454986|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454987|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454988|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454989|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454990|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454991|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454992|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
454993|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454994|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454995|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
454996|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
454997|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
454998|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
454999|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
455000|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
455001|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455029|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455002|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455003|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
455004|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
455005|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455006|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455007|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
455008|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455009|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455010|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
455011|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
455012|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455013|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455014|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
455015|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455016|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455017|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
455018|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
455019|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455020|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455021|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
455022|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455023|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455024|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
455025|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
455026|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455027|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455028|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
457252|NCT00852761|B3|Baseline|Total|Total of all reporting groups
455030|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455031|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
455032|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
455033|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455034|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455035|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
455036|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455037|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455038|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
455039|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455040|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455041|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
455042|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455043|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455044|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
455045|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
455046|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
455047|NCT00856544|E12|Reported Event|Placebo, Then CP-690,550 10 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 10 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 10 mg tablet twice daily from Month 6 to 12.
455048|NCT00856544|E11|Reported Event|Placebo, Then CP-690,550 5 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 5 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 5 mg tablet twice daily from Month 6 to 12.
455049|NCT00856544|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.
455050|NCT00856544|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
455051|NCT00856544|E8|Reported Event|Placebo, Then CP-690,550 10 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 10 mg tablet twice daily from Month 3 to 6.
455052|NCT00856544|E7|Reported Event|Placebo, Then CP-690,550 5 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 5 mg tablet twice daily from Month 3 to 6.
455053|NCT00856544|E6|Reported Event|Placebo (Month 3 to 6)|Matching placebo twice daily from Month 3 to 6.
455054|NCT00856544|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet twice daily from Month 3 to 6.
455055|NCT00856544|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg twice daily from Month 3 to 6.
455056|NCT00856544|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo Film-coated tablet orally twice daily up to Month 3.
455057|NCT00856544|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.
455058|NCT00856544|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.
455059|NCT00856518|B3|Baseline|Total|Total of all reporting groups
455060|NCT00856518|B2|Baseline|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
455061|NCT00856518|B1|Baseline|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
455062|NCT00856518|P2|Participant Flow|Arm 2: Sham Group|"sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
455063|NCT00856518|P1|Participant Flow|Arm 1: EMST|"Experimental Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
455095|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
455096|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
455064|NCT00856518|O2|Outcome|Arm 2: Sham Group|"The sham group undergoes the same 5-week EMST exercise as the experimental group using the same device but without a spring for minimal pressure load~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
455065|NCT00856518|O1|Outcome|Arm 1: EMST|"The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
455066|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
455067|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
455068|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
455069|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
455070|NCT00856518|E2|Reported Event|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
455071|NCT00856518|E1|Reported Event|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
455072|NCT00856492|B4|Baseline|Total|Total of all reporting groups
455073|NCT00856492|B3|Baseline|Arm 3 (AC+PEG-G / Nab-Paclitaxel)|Received ddAC x 6 first followed by nP x 12, without bevacizumab
455074|NCT00856492|B2|Baseline|Arm 2 (Nab-Paclitaxel / AC+PEG-G))|Received nP x 12 followed by ddAC x 6 without bevacizumab
455075|NCT00856492|B1|Baseline|Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
455076|NCT00856492|P3|Participant Flow|Arm 3 (AC+PEG-G / Nab-Paclitaxel)|ddAC x 6 followed by nP x 12 without bevacizumab
455077|NCT00856492|P2|Participant Flow|Arm 2 (Nab-Paclitaxel / AC+PEG-G)|Received nP x 12 without bevacizumab followed by ddAC x 6
455078|NCT00856492|P1|Participant Flow|Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
455079|NCT00856492|O3|Outcome|Arm III (AC+PEG-G - Nab-Paclitaxel)|Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
455080|NCT00856492|O2|Outcome|Arm II (Nab-Paclitaxel - AC+PEG-G)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
455081|NCT00856492|O1|Outcome|Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
455082|NCT00856492|O2|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
455083|NCT00856492|O1|Outcome|Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
455084|NCT00856492|O2|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Arm II received nP x 12 followed by ddAC x 6, and those randomized to Arm III received ddAC x 6 first followed by nP x 12, both without bevacizumab
455085|NCT00856492|O1|Outcome|Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
455086|NCT00856492|O2|Outcome|Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))|Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
455087|NCT00856492|O1|Outcome|Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
455088|NCT00856492|E3|Reported Event|Arm III (AC+PEG-G - Nab-Paclitaxel)|Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
455089|NCT00856492|E2|Reported Event|Arm II (Nab-Paclitaxel - AC+PEG-G)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
455090|NCT00856492|E1|Reported Event|Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
455091|NCT00856414|B1|Baseline|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
455092|NCT00856414|P1|Participant Flow|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
455093|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
455094|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
455098|NCT00856414|E1|Reported Event|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
455099|NCT00856388|B1|Baseline|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455100|NCT00856388|P1|Participant Flow|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455101|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
455102|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455103|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455104|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455105|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455106|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455107|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455108|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
455109|NCT00856388|E1|Reported Event|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
455110|NCT00856349|B1|Baseline|Analysis Cohort|"Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.~Therapy Programming Report (TPR): Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study."
455111|NCT00856349|P1|Participant Flow|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
455112|NCT00856349|O1|Outcome|Subjects With Final Programming Data Available|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.
455113|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
455114|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
455115|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
455116|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
455117|NCT00856349|O1|Outcome|Subjects With Paired Programming Data|Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
455118|NCT00856349|E1|Reported Event|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
455119|NCT00856323|B1|Baseline|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
455120|NCT00856323|P1|Participant Flow|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
455121|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
455122|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
455123|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
455124|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
455125|NCT00856323|E1|Reported Event|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
455126|NCT00856297|B6|Baseline|Total|Total of all reporting groups
455127|NCT00856297|B5|Baseline|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455128|NCT00856297|B4|Baseline|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
455129|NCT00856297|B3|Baseline|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
455130|NCT00856297|B2|Baseline|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
455131|NCT00856297|B1|Baseline|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455132|NCT00856297|P5|Participant Flow|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455133|NCT00856297|P4|Participant Flow|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455134|NCT00856297|P3|Participant Flow|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
455135|NCT00856297|P2|Participant Flow|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
455136|NCT00856297|P1|Participant Flow|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455137|NCT00856297|O3|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
455138|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
455139|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455140|NCT00856297|O4|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455141|NCT00856297|O3|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455142|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination..
455143|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455144|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455145|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455146|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455147|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455148|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455149|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455150|NCT00856297|O2|Outcome|Licensed Comparator/MenACWY-CRM|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study, and one booster dose of MenACWY- CRM conjugate vaccine in the present study at 3 years after primary vaccination.
455151|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455152|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
455153|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
455154|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
455155|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455156|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
455157|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455158|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
455159|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455160|NCT00856297|E5|Reported Event|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
455161|NCT00856297|E4|Reported Event|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
455162|NCT00856297|E3|Reported Event|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
455163|NCT00856297|E2|Reported Event|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
455164|NCT00856297|E1|Reported Event|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
455165|NCT00856284|B4|Baseline|Total|Total of all reporting groups
455166|NCT00856284|B3|Baseline|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455167|NCT00856284|B2|Baseline|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455168|NCT00856284|B1|Baseline|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455169|NCT00856284|P3|Participant Flow|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455170|NCT00856284|P2|Participant Flow|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455171|NCT00856284|P1|Participant Flow|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455172|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455173|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
461466|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
455174|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455175|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455176|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455177|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455178|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455179|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455180|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455181|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455182|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455183|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455184|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455185|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455186|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455187|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455188|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455189|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455190|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455191|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455192|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455193|NCT00856284|E3|Reported Event|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
455194|NCT00856284|E2|Reported Event|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455195|NCT00856284|E1|Reported Event|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
455196|NCT00856245|B1|Baseline|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
455197|NCT00856245|P1|Participant Flow|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
455198|NCT00856245|O1|Outcome|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
455199|NCT00856245|O1|Outcome|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
455200|NCT00856245|E1|Reported Event|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
455201|NCT00856232|B4|Baseline|Total|Total of all reporting groups
455202|NCT00856232|B3|Baseline|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
455203|NCT00856232|B2|Baseline|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
455204|NCT00856232|B1|Baseline|Standard Therapy|Standard emergency department evaluation and treatment for headache
455205|NCT00856232|P3|Participant Flow|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
455206|NCT00856232|P2|Participant Flow|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
455207|NCT00856232|P1|Participant Flow|Standard Therapy|Standard emergency department evaluation and treatment for headache
455208|NCT00856232|O3|Outcome|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
455209|NCT00856232|O2|Outcome|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
455210|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
455211|NCT00856232|O3|Outcome|Oxygen at 15 L / Min|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
455212|NCT00856232|O2|Outcome|Medical Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
455213|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
455214|NCT00856232|E3|Reported Event|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
455215|NCT00856232|E2|Reported Event|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
455216|NCT00856232|E1|Reported Event|Standard Therapy|Standard emergency department evaluation and treatment for headache
455217|NCT00856206|B3|Baseline|Total|Total of all reporting groups
455218|NCT00856206|B2|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455219|NCT00856206|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
455220|NCT00856206|P2|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455221|NCT00856206|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
455222|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455223|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
455224|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455225|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
455226|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455227|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
455228|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455229|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
455230|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455231|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
455232|NCT00856206|E2|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
455233|NCT00856206|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
455234|NCT00856193|B1|Baseline|All Randomized Patients|NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Matching placebo 50 µg capsules for inhalation once daily with Concept 1 device.
455235|NCT00856193|P2|Participant Flow|Placebo Then NVA237 50μg|Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device.
455236|NCT00856193|P1|Participant Flow|NVA237 50μg Then Placebo|NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
455237|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455238|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455239|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455240|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455241|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455242|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455243|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455244|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455245|NCT00856193|E2|Reported Event|NVA237 50 μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455246|NCT00856193|E1|Reported Event|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
455247|NCT00856180|B1|Baseline|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
455248|NCT00856180|P1|Participant Flow|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
455249|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
455250|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
455251|NCT00856180|O2|Outcome|Platinum Resistant|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a </=6 month interval since last receiving platinum therapy prior to disease recurrence.
455252|NCT00856180|O1|Outcome|Platinum Sensitive|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum sensitive is defined as having had a >6 month interval since last receiving platinum therapy prior to disease recurrence.
455253|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
455254|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
455255|NCT00856180|E1|Reported Event|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
455256|NCT00856050|B1|Baseline|Letrozole|letrozole 2.5mg by mouth per day
455257|NCT00856050|P1|Participant Flow|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
455258|NCT00856050|O1|Outcome|Letrozole|letrozole 2.5mg by mouth per day
455259|NCT00856050|E1|Reported Event|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
455260|NCT00856024|B1|Baseline|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455261|NCT00856024|P1|Participant Flow|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455262|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455263|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455264|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455288|NCT00855933|B2|Baseline|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455265|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455266|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455267|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455268|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455269|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455270|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455271|NCT00856024|E1|Reported Event|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
455272|NCT00855959|B1|Baseline|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455273|NCT00855959|P1|Participant Flow|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455274|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455275|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455276|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455277|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455278|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455279|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455280|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455281|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455282|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455283|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455284|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455285|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455286|NCT00855959|E1|Reported Event|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
455287|NCT00855933|B3|Baseline|Total|Total of all reporting groups
455289|NCT00855933|B1|Baseline|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455290|NCT00855933|P2|Participant Flow|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455291|NCT00855933|P1|Participant Flow|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455292|NCT00855933|O2|Outcome|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455293|NCT00855933|O1|Outcome|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455294|NCT00855933|E2|Reported Event|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455295|NCT00855933|E1|Reported Event|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
455296|NCT00855920|B4|Baseline|Total|Total of all reporting groups
455297|NCT00855920|B3|Baseline|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
455298|NCT00855920|B2|Baseline|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455299|NCT00855920|B1|Baseline|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455300|NCT00855920|P3|Participant Flow|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
455301|NCT00855920|P2|Participant Flow|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455302|NCT00855920|P1|Participant Flow|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455303|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
455304|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455305|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455306|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
455307|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455308|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455309|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
455310|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455311|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455312|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
455313|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455314|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
455315|NCT00855920|E3|Reported Event|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
455316|NCT00855920|E2|Reported Event|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in arm (Placebo [for Rilonacept] and Indomethacin).
455354|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
461467|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
455317|NCT00855920|E1|Reported Event|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in this arm.
455318|NCT00855894|B1|Baseline|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455319|NCT00855894|P1|Participant Flow|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455320|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455321|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455322|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455323|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455324|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455325|NCT00855894|E1|Reported Event|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
455326|NCT00855868|B3|Baseline|Total|Total of all reporting groups
455327|NCT00855868|B2|Baseline|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
455328|NCT00855868|B1|Baseline|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
455329|NCT00855868|P2|Participant Flow|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
455330|NCT00855868|P1|Participant Flow|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
455331|NCT00855868|O2|Outcome|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
455332|NCT00855868|O1|Outcome|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
455333|NCT00855868|E2|Reported Event|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
455334|NCT00855868|E1|Reported Event|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
455335|NCT00855842|B1|Baseline|Osmotic Dilator|osmotic dilator
455336|NCT00855842|P1|Participant Flow|Osmotic Dilator|osmotic dilator
455337|NCT00855842|O1|Outcome|Osmotic Dilator|osmotic dilator
455338|NCT00855842|E1|Reported Event|Osmotic Dilator|osmotic dilator
455339|NCT00855816|B3|Baseline|Total|Total of all reporting groups
455340|NCT00855816|B2|Baseline|Treatment as Usual|No intervention: Treatment as usual
455341|NCT00855816|B1|Baseline|Breathing Training|relaxation training
455342|NCT00855816|P2|Participant Flow|Treatment as Usual|No intervention - treatment as usual
455343|NCT00855816|P1|Participant Flow|Breathing Training|relaxation training
455344|NCT00855816|O2|Outcome|Treatment as Usual|No intervention: treatment as usual
455345|NCT00855816|O1|Outcome|Breathing Training|relaxation training
455346|NCT00855816|E2|Reported Event|Treatment as Usual|No intervention: Treatment as usual
455347|NCT00855816|E1|Reported Event|Breathing Training|relaxation training
455348|NCT00855738|B1|Baseline|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455349|NCT00855738|P1|Participant Flow|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455350|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455351|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455352|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455353|NCT00855738|O1|Outcome|All Antiepileptic Drugs|
455355|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455356|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455357|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455358|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455359|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455360|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455361|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455362|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455363|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455364|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455365|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455366|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455367|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455368|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455369|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455370|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455371|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
455372|NCT00855738|E2|Reported Event|Pregabalin (Pregabalin Only)|
455373|NCT00855738|E1|Reported Event|All Antiepileptic Drugs (Including Pregabalin)|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin
455374|NCT00855595|B3|Baseline|Total|Total of all reporting groups
455375|NCT00855595|B2|Baseline|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455376|NCT00855595|B1|Baseline|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455377|NCT00855595|P2|Participant Flow|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455378|NCT00855595|P1|Participant Flow|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455379|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455380|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455381|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455382|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455383|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455384|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455385|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455386|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455387|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455388|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455435|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455389|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455390|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455391|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455392|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455393|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455394|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455395|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455396|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455397|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455398|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455399|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455400|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455401|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455402|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455403|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455404|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455405|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455406|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455407|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455408|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455409|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
455410|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
455411|NCT00855595|E2|Reported Event|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks
455412|NCT00855595|E1|Reported Event|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks
455413|NCT00855582|B4|Baseline|Total|Total of all reporting groups
455414|NCT00855582|B3|Baseline|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455415|NCT00855582|B2|Baseline|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455416|NCT00855582|B1|Baseline|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455417|NCT00855582|P3|Participant Flow|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455418|NCT00855582|P2|Participant Flow|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455419|NCT00855582|P1|Participant Flow|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455420|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455421|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455422|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455423|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455424|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455425|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455426|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455427|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455428|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455429|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455430|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455431|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455432|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455433|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455434|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455436|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455437|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455438|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455439|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455440|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455441|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455442|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455443|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455444|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455445|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455446|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455447|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455448|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455449|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455450|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455451|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455452|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455453|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455454|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455455|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455456|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455457|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455458|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455459|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455460|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455461|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455462|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455463|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455464|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455465|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455466|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455467|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455468|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455469|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455470|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455471|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455472|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455473|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455474|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455475|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455476|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455477|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455478|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455479|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455480|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455481|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455482|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455483|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455484|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455485|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455486|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455487|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
455488|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455489|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
455490|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455491|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
455492|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455493|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
455494|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455495|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
455496|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455497|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
455498|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455499|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
455500|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455501|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
455502|NCT00855582|E3|Reported Event|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
455503|NCT00855582|E2|Reported Event|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
455504|NCT00855582|E1|Reported Event|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
455505|NCT00855465|B3|Baseline|Total|Total of all reporting groups
455506|NCT00855465|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455507|NCT00855465|B1|Baseline|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455508|NCT00855465|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455509|NCT00855465|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455510|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455511|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455512|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455513|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455514|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455515|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455516|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455517|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455518|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455519|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455520|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455521|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455522|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455523|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455524|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455525|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455526|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455527|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455528|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455529|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455530|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455531|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455532|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455533|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455534|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455535|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455536|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455570|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
456383|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode pacing impedance at 6 month.
455537|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455538|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455539|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455540|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455541|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455542|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455543|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455544|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455545|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455546|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455547|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455548|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455549|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455550|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455551|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455552|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455553|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455554|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455555|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455556|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455557|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455558|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455559|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455560|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455561|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455562|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455563|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455564|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455565|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455566|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455567|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455568|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455569|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455571|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455572|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455573|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455574|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455575|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455576|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455577|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455578|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455579|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455580|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455581|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455582|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455583|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455584|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455585|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455586|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455587|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455588|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455589|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455590|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455591|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455592|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455593|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455594|NCT00855465|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
455595|NCT00855465|E1|Reported Event|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
455596|NCT00855439|B3|Baseline|Total|Total of all reporting groups
455597|NCT00855439|B2|Baseline|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
455598|NCT00855439|B1|Baseline|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
455599|NCT00855439|P2|Participant Flow|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
455600|NCT00855439|P1|Participant Flow|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
455601|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
455602|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
455603|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
455604|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
455605|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
455606|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
455607|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
455608|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
455609|NCT00855439|E2|Reported Event|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
455610|NCT00855439|E1|Reported Event|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
455611|NCT00855413|B1|Baseline|Acute HIV Infection Treatment Group|All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.
455612|NCT00855413|P1|Participant Flow|Acute HIV Infection Treatment Group|All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.
455613|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455614|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455615|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455616|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455617|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455618|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455619|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455620|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455621|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455622|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455623|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455624|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455625|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455626|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455627|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455820|NCT00855062|E2|Reported Event|Placebo|Placebo minocycline capsules every 12 hours
455628|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455629|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455630|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455631|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455632|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455633|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455634|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455635|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455636|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455637|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455638|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455639|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455640|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455641|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455642|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455643|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455644|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455645|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455646|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455647|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455648|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455649|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455650|NCT00855413|O1|Outcome|Acute HIV Infection Treatment Group|Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
455651|NCT00855413|E1|Reported Event|Darunavir/Ritonavir and Etravirine|"Darunavir/Ritonavir and Etravirine~DRV/r will be administered 800 mg/100 mg orally once daily.~ETR will be given 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen.~Darunavir/Ritonavir and Etravirine: DRV/r will be administered 800 mg/100 mg orally once daily.~ETR will be given 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen."
455652|NCT00855335|B6|Baseline|Total|Total of all reporting groups
455653|NCT00855335|B5|Baseline|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455654|NCT00855335|B4|Baseline|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455655|NCT00855335|B3|Baseline|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455656|NCT00855335|B2|Baseline|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455657|NCT00855335|B1|Baseline|Darunavir 600 mg /Ritonavir 100 mg Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455821|NCT00855062|E1|Reported Event|Minocycline|Minocycline 100 mg orally every 12 hours
455658|NCT00855335|P5|Participant Flow|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455659|NCT00855335|P4|Participant Flow|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455660|NCT00855335|P3|Participant Flow|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455661|NCT00855335|P2|Participant Flow|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455662|NCT00855335|P1|Participant Flow|Darunavir 600 mg /Ritonavir 100 mg Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455663|NCT00855335|O5|Outcome|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455664|NCT00855335|O4|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455665|NCT00855335|O3|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455666|NCT00855335|O2|Outcome|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455667|NCT00855335|O1|Outcome|Darunavir 600 mg /Ritonavir 100 Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455668|NCT00855335|O5|Outcome|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455669|NCT00855335|O4|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455670|NCT00855335|O3|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455671|NCT00855335|O2|Outcome|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455672|NCT00855335|O1|Outcome|Darunavir 600 mg /Ritonavir 100 Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455673|NCT00855335|O8|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455674|NCT00855335|O7|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455675|NCT00855335|O6|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455676|NCT00855335|O5|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455677|NCT00855335|O4|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
455678|NCT00855335|O3|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
455679|NCT00855335|O2|Outcome|Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
455680|NCT00855335|O1|Outcome|Darunavir 600 mg (Darunavir 600/Ritonavir 100) Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
455681|NCT00855335|O5|Outcome|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455682|NCT00855335|O4|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455683|NCT00855335|O3|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455684|NCT00855335|O2|Outcome|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455685|NCT00855335|O1|Outcome|Darunavir 600 mg /Ritonavir 100 Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455686|NCT00855335|O5|Outcome|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455687|NCT00855335|O4|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455688|NCT00855335|O3|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455689|NCT00855335|O2|Outcome|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455690|NCT00855335|O1|Outcome|Darunavir 600 mg /Ritonavir 100 Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
456693|NCT00853333|B3|Baseline|Propofol|
455691|NCT00855335|O5|Outcome|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455692|NCT00855335|O4|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455693|NCT00855335|O3|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455694|NCT00855335|O2|Outcome|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455695|NCT00855335|O1|Outcome|Darunavir 600 mg /Ritonavir 100 Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455696|NCT00855335|O5|Outcome|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455697|NCT00855335|O4|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455698|NCT00855335|O3|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455699|NCT00855335|O2|Outcome|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455700|NCT00855335|O1|Outcome|Darunavir 600 mg /Ritonavir 100 Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455701|NCT00855335|O5|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455702|NCT00855335|O4|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455703|NCT00855335|O3|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455704|NCT00855335|O2|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
455705|NCT00855335|O1|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
455706|NCT00855335|O3|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455707|NCT00855335|O2|Outcome|Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
455708|NCT00855335|O1|Outcome|Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
455709|NCT00855335|O8|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455710|NCT00855335|O7|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455711|NCT00855335|O6|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455712|NCT00855335|O5|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455713|NCT00855335|O4|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
455714|NCT00855335|O3|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
455715|NCT00855335|O2|Outcome|Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
455716|NCT00855335|O1|Outcome|Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
455717|NCT00855335|O8|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455718|NCT00855335|O7|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455719|NCT00855335|O6|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455720|NCT00855335|O5|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455721|NCT00855335|O4|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
455722|NCT00855335|O3|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
455822|NCT00855010|B3|Baseline|Total|Total of all reporting groups
455723|NCT00855335|O2|Outcome|Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
455724|NCT00855335|O1|Outcome|Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
455725|NCT00855335|O8|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455726|NCT00855335|O7|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455727|NCT00855335|O6|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455728|NCT00855335|O5|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455729|NCT00855335|O4|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
455730|NCT00855335|O3|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
455731|NCT00855335|O2|Outcome|Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
455732|NCT00855335|O1|Outcome|Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
455733|NCT00855335|O8|Outcome|Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455734|NCT00855335|O7|Outcome|Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily|Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455735|NCT00855335|O6|Outcome|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455736|NCT00855335|O5|Outcome|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455737|NCT00855335|O4|Outcome|Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.
455738|NCT00855335|O3|Outcome|Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily|Participants received darunavir 800 mg tablets (400*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.
455739|NCT00855335|O2|Outcome|Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.
455740|NCT00855335|O1|Outcome|Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.
455741|NCT00855335|E5|Reported Event|Darunavir 800 mg/Cobicistat 150 mg Once Daily|Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.
455742|NCT00855335|E4|Reported Event|Rilpivirine 25 mg Once Daily|Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.
455743|NCT00855335|E3|Reported Event|Etravirine 200 mg Twice Daily|Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
455744|NCT00855335|E2|Reported Event|Darunavir 800 mg /Ritonavir 100 mg Once Daily|Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
455745|NCT00855335|E1|Reported Event|Darunavir 600 mg /Ritonavir 100 mg Twice Daily|Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
455746|NCT00855309|B3|Baseline|Total|Total of all reporting groups
455747|NCT00855309|B2|Baseline|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
455748|NCT00855309|B1|Baseline|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
455749|NCT00855309|P2|Participant Flow|Low-dose IV Acyclovir|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
455750|NCT00855309|P1|Participant Flow|Weight-based IV Acyclovir|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
455751|NCT00855309|O2|Outcome|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
455752|NCT00855309|O1|Outcome|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
455753|NCT00855309|E2|Reported Event|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
455754|NCT00855309|E1|Reported Event|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
455755|NCT00855218|B3|Baseline|Total|Total of all reporting groups
455756|NCT00855218|B2|Baseline|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455823|NCT00855010|B2|Baseline|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19"
455824|NCT00855010|B1|Baseline|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23"
455757|NCT00855218|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455758|NCT00855218|P2|Participant Flow|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455759|NCT00855218|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455760|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455761|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455762|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455763|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455764|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455765|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455766|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455767|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455768|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455769|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455770|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455771|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455772|NCT00855218|E2|Reported Event|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455773|NCT00855218|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
455774|NCT00855166|B3|Baseline|Total|Total of all reporting groups
455775|NCT00855166|B2|Baseline|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
455776|NCT00855166|B1|Baseline|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
455777|NCT00855166|P2|Participant Flow|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
455778|NCT00855166|P1|Participant Flow|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
455779|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
455780|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
455781|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
455782|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
455783|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
455784|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
455785|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
455786|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
455787|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
455788|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
455789|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
455790|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
455791|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
455792|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
455793|NCT00855166|E2|Reported Event|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
455794|NCT00855166|E1|Reported Event|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
455795|NCT00855062|B3|Baseline|Total|Total of all reporting groups
455796|NCT00855062|B2|Baseline|Placebo|Placebo minocycline capsules every 12 hours
455797|NCT00855062|B1|Baseline|Minocycline|Minocycline 100 mg orally every 12 hours
455798|NCT00855062|P2|Participant Flow|Placebo|Placebo minocycline capsules every 12 hours
455799|NCT00855062|P1|Participant Flow|Minocycline|Minocycline 100 mg orally every 12 hours
455800|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455801|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455802|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455803|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455804|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455805|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455806|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455807|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455808|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455809|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455810|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455811|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455812|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455813|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455814|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455815|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455816|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455817|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
455818|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
455819|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
456694|NCT00853333|B2|Baseline|Midazolam|
455825|NCT00855010|P2|Participant Flow|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455826|NCT00855010|P1|Participant Flow|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455827|NCT00855010|O2|Outcome|Placebo Pill:|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily"
455828|NCT00855010|O1|Outcome|Pioglitazone:|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily"
455829|NCT00855010|O2|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455830|NCT00855010|O1|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455831|NCT00855010|O2|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455832|NCT00855010|O1|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455833|NCT00855010|O2|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455834|NCT00855010|O1|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455835|NCT00855010|O2|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455836|NCT00855010|O1|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455837|NCT00855010|O2|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily"
455838|NCT00855010|O1|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily"
455839|NCT00855010|O2|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455840|NCT00855010|O1|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455841|NCT00855010|O2|Outcome|Placebo Pill:|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily"
455842|NCT00855010|O1|Outcome|Pioglitazone:|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily"
455843|NCT00855010|O2|Outcome|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455844|NCT00855010|O1|Outcome|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455845|NCT00855010|E2|Reported Event|Placebo Pill|"placebo pill once daily (look-alike pill which contains no active ingredients)~placebo: one daily: 19 subjects"
455846|NCT00855010|E1|Reported Event|Pioglitazone|"pioglitazone tablet 45 mg once daily~pioglitazone: pioglitazone 45 mg daily: 23 subjects"
455847|NCT00854906|B1|Baseline|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). All study participants participated in both the KTBUT Study Arm and the FTBUT Study Arm.
455848|NCT00854906|P1|Participant Flow|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). Both KTBUT and FTBUT were measured in all study participants.
455849|NCT00854906|O1|Outcome|All Study Participants|
455850|NCT00854906|O2|Outcome|FTBUT|
455851|NCT00854906|O1|Outcome|KTBUT|
455852|NCT00854906|E2|Reported Event|FTBUT|
455853|NCT00854906|E1|Reported Event|KTBUT|
455854|NCT00854724|B3|Baseline|Total|Total of all reporting groups
455855|NCT00854724|B2|Baseline|Puerarin, Then Placebo|
455856|NCT00854724|B1|Baseline|Placebo, Then Puerarin|
455857|NCT00854724|P2|Participant Flow|Puerarin, Then Placebo|
455858|NCT00854724|P1|Participant Flow|Placebo, Then Puerarin|
455859|NCT00854724|O2|Outcome|Puerarin, Then Placebo|
455860|NCT00854724|O1|Outcome|Placebo, Then Puerarin|
455861|NCT00854724|E2|Reported Event|Puerarin, Then Placebo|
455862|NCT00854724|E1|Reported Event|Placebo, Then Puerarin|
455863|NCT00854620|B1|Baseline|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
455864|NCT00854620|P1|Participant Flow|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
455865|NCT00854620|O1|Outcome|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
455866|NCT00854620|E1|Reported Event|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
455867|NCT00854607|B1|Baseline|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
455868|NCT00854607|P1|Participant Flow|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven Invasive Aspergillosis (IA) infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
455869|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
455870|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
455871|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
456695|NCT00853333|B1|Baseline|Dexmedetomidine|
455872|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455873|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
455874|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
455875|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
455876|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455877|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
455878|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
455879|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
455880|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455881|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
455882|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
455883|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
455884|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455885|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
455886|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
455887|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
455888|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
455889|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
455890|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
455891|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
455892|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455893|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
455894|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455895|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
455896|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455897|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 6.
455898|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
455899|NCT00854607|E1|Reported Event|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, and were started on standard of care antifungal therapy.
455900|NCT00854594|B3|Baseline|Total|Total of all reporting groups
455901|NCT00854594|B2|Baseline|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
455902|NCT00854594|B1|Baseline|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
455903|NCT00854594|P2|Participant Flow|ReSPECT Intervention|"Providers within sites randomized to the intervention arm will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention Community-Based Outpatient Clinics (CBOCs) by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
455904|NCT00854594|P1|Participant Flow|Control|Providers within sites randomized to the control arm will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
455953|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455905|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
455906|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
455907|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
455908|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
455909|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
455910|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
455911|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
455912|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
455913|NCT00854594|E2|Reported Event|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
455914|NCT00854594|E1|Reported Event|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
455915|NCT00854581|B1|Baseline|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
455916|NCT00854581|P1|Participant Flow|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
455917|NCT00854581|O1|Outcome|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
455918|NCT00854581|O1|Outcome|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
455919|NCT00854581|O1|Outcome|Part 2B Maintenance (Up to 12 Months)|"Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:~Zidovudine: 600 mg or 300 mg orally twice daily, per protocol~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol~Valproic acid, 250 mg orally twice daily, per protocol~Valproic Acid: Administered orally."
455949|NCT00854360|P1|Participant Flow|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) and two actuations of placebo HFA once daily.
455950|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455951|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455920|NCT00854581|O1|Outcome|Induction (Up to Day 21)|"For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:~Zidovudine:~Days 1-2: 1.5 grams intravenously (IV) twice daily~Days 3-21: 1.5 grams IV twice daily~Interferon alfa-2b (IFN):~5 10 million units (mu) intravenously twice daily~Interferon alfa-2b: Administered intravenously.~Zidovudine: Administered intravenously during Induction Therapy; orally during Maintenance Therapy in all Phases (1, 2A and 2B)."
455921|NCT00854581|O1|Outcome|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
455922|NCT00854581|O1|Outcome|Part 2B Maintenance (Up to 12 Months)|"Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:~Zidovudine: 600 mg or 300 mg orally twice daily, per protocol~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol~Valproic acid, 250 mg orally twice daily, per protocol~Valproic Acid: Administered orally."
455923|NCT00854581|O1|Outcome|Induction + Maintenance|All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
455924|NCT00854581|E4|Reported Event|Part 2B Maintenance|"Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:~Zidovudine: 600 mg or 300 mg orally twice daily, per protocol~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol~Valproic acid, 250 mg orally twice daily, per protocol"
455925|NCT00854581|E3|Reported Event|Part 2A Maintenance|"Participants achieving a CR with undetectable clonal disease. Participants will receive therapy for as long as response is maintained:~Zidovudine: 600 mg orally twice daily~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly"
455926|NCT00854581|E2|Reported Event|Part 1 Maintenance|"From Treatment Day 14 or 21 to start of Month 3 (Day 60). Study participants move on to Part 1 Maintenance Therapy only if they achieve complete response (CR) or partial response (PR) after induction therapy. Restaging and molecular evaluation of disease at start of Month 3:~Zidovudine: 600 mg orally twice daily in all phases of Maintenance Therapy~PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly~Participants then proceed to Part 2 maintenance."
455927|NCT00854581|E1|Reported Event|Induction Therapy|"For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:~Zidovudine:~Days 1-2: 1.5 grams intravenously (IV) twice daily~Days 3-21: 1.5 grams IV twice daily~Interferon alfa-2b (IFN):~5 10 million units (mu) intravenously twice daily"
455928|NCT00854373|B3|Baseline|Total|Total of all reporting groups
455929|NCT00854373|B2|Baseline|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
455930|NCT00854373|B1|Baseline|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
455931|NCT00854373|P2|Participant Flow|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
455932|NCT00854373|P1|Participant Flow|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
455933|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
455934|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
455935|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
455936|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
455937|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
455938|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
455939|NCT00854373|E2|Reported Event|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
455940|NCT00854373|E1|Reported Event|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
455941|NCT00854360|B5|Baseline|Total|Total of all reporting groups
455942|NCT00854360|B4|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455943|NCT00854360|B3|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455944|NCT00854360|B2|Baseline|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455945|NCT00854360|B1|Baseline|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455946|NCT00854360|P4|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455947|NCT00854360|P3|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455948|NCT00854360|P2|Participant Flow|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455952|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455954|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455955|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455956|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455957|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455958|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455959|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455960|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455961|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455962|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455963|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455964|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455965|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455966|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455967|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455968|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455969|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455970|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455971|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455972|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455973|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455974|NCT00854360|E4|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
455975|NCT00854360|E3|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
455976|NCT00854360|E2|Reported Event|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
455977|NCT00854360|E1|Reported Event|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
455978|NCT00854308|B3|Baseline|Total|Total of all reporting groups
455979|NCT00854308|B2|Baseline|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
455980|NCT00854308|B1|Baseline|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455981|NCT00854308|P2|Participant Flow|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
455982|NCT00854308|P1|Participant Flow|MetMAb + Erlotinib|MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455983|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
455984|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455985|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
455986|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455987|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
455988|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455989|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
461468|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
455990|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455991|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
455992|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455993|NCT00854308|E2|Reported Event|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
455994|NCT00854308|E1|Reported Event|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
455995|NCT00854113|B12|Baseline|Total|Total of all reporting groups
455996|NCT00854113|B11|Baseline|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
455997|NCT00854113|B10|Baseline|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
455998|NCT00854113|B9|Baseline|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
455999|NCT00854113|B8|Baseline|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456000|NCT00854113|B7|Baseline|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456001|NCT00854113|B6|Baseline|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456002|NCT00854113|B5|Baseline|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456003|NCT00854113|B4|Baseline|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456004|NCT00854113|B3|Baseline|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456005|NCT00854113|B2|Baseline|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456006|NCT00854113|B1|Baseline|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456007|NCT00854113|P11|Participant Flow|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456008|NCT00854113|P10|Participant Flow|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456009|NCT00854113|P9|Participant Flow|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456010|NCT00854113|P8|Participant Flow|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456011|NCT00854113|P7|Participant Flow|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456012|NCT00854113|P6|Participant Flow|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456013|NCT00854113|P5|Participant Flow|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456014|NCT00854113|P4|Participant Flow|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456015|NCT00854113|P3|Participant Flow|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456016|NCT00854113|P2|Participant Flow|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456017|NCT00854113|P1|Participant Flow|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456018|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456019|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456020|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456021|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456022|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456023|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456024|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456025|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456026|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456027|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456028|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456029|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456030|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456031|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456032|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456033|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456034|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456035|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456036|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456037|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456038|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
461469|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
456039|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456040|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456041|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456042|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456043|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456044|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456045|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456046|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456047|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456048|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456049|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456050|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456051|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456052|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456053|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456054|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456055|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456056|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456057|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456058|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456059|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456060|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456061|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456062|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456063|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456064|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456065|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456066|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456067|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456068|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456069|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456070|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456071|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456072|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456073|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456074|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456075|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456076|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456077|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456078|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456079|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456080|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456081|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456082|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456083|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456084|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456085|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456086|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456087|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456088|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456089|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
457935|NCT00850759|E4|Reported Event|No-contact Control|no-contact control group.
456090|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456091|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456092|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456093|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456094|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456095|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456096|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456097|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456098|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456099|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456100|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456101|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456102|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456103|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456104|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456105|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456106|NCT00854113|E11|Reported Event|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
456107|NCT00854113|E10|Reported Event|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
456108|NCT00854113|E9|Reported Event|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
456109|NCT00854113|E8|Reported Event|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
456110|NCT00854113|E7|Reported Event|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
456111|NCT00854113|E6|Reported Event|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
456112|NCT00854113|E5|Reported Event|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
456113|NCT00854113|E4|Reported Event|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
456114|NCT00854113|E3|Reported Event|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
456115|NCT00854113|E2|Reported Event|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
456116|NCT00854113|E1|Reported Event|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
456117|NCT00854087|B3|Baseline|Total|Total of all reporting groups
456118|NCT00854087|B2|Baseline|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
456119|NCT00854087|B1|Baseline|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
456120|NCT00854087|P2|Participant Flow|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
456121|NCT00854087|P1|Participant Flow|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
456122|NCT00854087|O2|Outcome|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
456123|NCT00854087|O1|Outcome|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
456124|NCT00854087|E2|Reported Event|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
456125|NCT00854087|E1|Reported Event|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
456126|NCT00853996|B1|Baseline|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456127|NCT00853996|P1|Participant Flow|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456128|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456129|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456130|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456131|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456132|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456133|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456378|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration threshold captured at 0.5ms at 6 month.
456134|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456135|NCT00853996|E1|Reported Event|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
456136|NCT00853970|B3|Baseline|Total|Total of all reporting groups
456137|NCT00853970|B2|Baseline|Placebo|one drop daily in study eye for 2 weeks
456138|NCT00853970|B1|Baseline|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
456139|NCT00853970|P2|Participant Flow|Placebo|dosed 1 drop daily into the study eye for 2 weeks
456140|NCT00853970|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.09%|dosed 1 drop daily into the study eye for 2 weeks
456141|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
456142|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
456143|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
456144|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
456145|NCT00853970|E2|Reported Event|Placebo|one drop daily in study eye for 2 weeks
456146|NCT00853970|E1|Reported Event|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
456147|NCT00853957|B3|Baseline|Total|Total of all reporting groups
456148|NCT00853957|B2|Baseline|Amlodipine|Amlodipine 5mg titrated to 10 mg
456149|NCT00853957|B1|Baseline|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456150|NCT00853957|P2|Participant Flow|Amlodipine|Amlodipine 5mg titrated to 10 mg
456151|NCT00853957|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456152|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
456153|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456154|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
456155|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456156|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
456157|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456158|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
456159|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456160|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
456161|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456162|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
456163|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456164|NCT00853957|E2|Reported Event|Amlodipine|Amlodipine 5mg titrated to 10 mg
456165|NCT00853957|E1|Reported Event|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
456166|NCT00853905|B3|Baseline|Total|Total of all reporting groups
456167|NCT00853905|B2|Baseline|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
456168|NCT00853905|B1|Baseline|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
456169|NCT00853905|P2|Participant Flow|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
456170|NCT00853905|P1|Participant Flow|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
456171|NCT00853905|O2|Outcome|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
456172|NCT00853905|O1|Outcome|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
456173|NCT00853905|E2|Reported Event|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
456174|NCT00853905|E1|Reported Event|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
456175|NCT00853840|B1|Baseline|All Subjects|In this 2-way crossover study, in Period 1, all 18 subjects were randomized to receive a single dose of either vardenafil 20 mg (Treatment A) or placebo (Treatment B), subsequent to treatment with 3 to 4 days of maraviroc 300 mg BID. All subjects were then crossed over to receive the second treatment in Period 2.
456176|NCT00853840|P2|Participant Flow|Non-matching Placebo + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
461470|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
456177|NCT00853840|P1|Participant Flow|Vardenafil + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
456178|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
456179|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
456180|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
456181|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
456182|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
456183|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
456184|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
456185|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
456186|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
456187|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
456188|NCT00853840|E3|Reported Event|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
456189|NCT00853840|E2|Reported Event|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was to be taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
456190|NCT00853840|E1|Reported Event|Maraviroc Run-In|All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).
456191|NCT00853827|B3|Baseline|Total|Total of all reporting groups
456192|NCT00853827|B2|Baseline|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
456193|NCT00853827|B1|Baseline|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
456194|NCT00853827|P2|Participant Flow|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
456195|NCT00853827|P1|Participant Flow|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
456196|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
456197|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
461471|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
456198|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
456199|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
456200|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
456201|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
456202|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
456203|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
456204|NCT00853827|E2|Reported Event|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
456205|NCT00853827|E1|Reported Event|Aliskiren 300 mg|Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
456206|NCT00853762|B5|Baseline|Total|Total of all reporting groups
456207|NCT00853762|B4|Baseline|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456208|NCT00853762|B3|Baseline|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456209|NCT00853762|B2|Baseline|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456210|NCT00853762|B1|Baseline|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456211|NCT00853762|P4|Participant Flow|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456212|NCT00853762|P3|Participant Flow|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456213|NCT00853762|P2|Participant Flow|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456214|NCT00853762|P1|Participant Flow|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456215|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456216|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456217|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456218|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456219|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456220|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456221|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456222|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456223|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456224|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456225|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456226|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456227|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456228|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456229|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456230|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456231|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456232|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456233|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456234|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456235|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456236|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456237|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456238|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456239|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456379|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at implant.
456240|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456241|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456242|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456243|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456244|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456245|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456246|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456247|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456248|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456249|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456250|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456251|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456252|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456253|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456254|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456255|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456256|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456257|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456258|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456259|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456260|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456380|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode pacing impedance at 6 month.
456261|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456262|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456263|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456264|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456265|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456266|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456267|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456268|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456269|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456270|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456271|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456272|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456273|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456274|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456275|NCT00853762|E4|Reported Event|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC as loading dose twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456276|NCT00853762|E3|Reported Event|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456277|NCT00853762|E2|Reported Event|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456278|NCT00853762|E1|Reported Event|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
456279|NCT00853749|B3|Baseline|Total|Total of all reporting groups
456280|NCT00853749|B2|Baseline|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456281|NCT00853749|B1|Baseline|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456282|NCT00853749|P2|Participant Flow|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
458341|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
456283|NCT00853749|P1|Participant Flow|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456284|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456285|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456286|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456287|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456288|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456289|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456290|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456291|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456292|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456293|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456294|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456295|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456296|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
456297|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
456298|NCT00853749|E2|Reported Event|PCV/PCV/13vPnC|"For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5."
456299|NCT00853749|E1|Reported Event|PCV/23vPS/13vPnC|"For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9."
456300|NCT00853723|B4|Baseline|Total|Total of all reporting groups
456301|NCT00853723|B3|Baseline|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456302|NCT00853723|B2|Baseline|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456303|NCT00853723|B1|Baseline|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456304|NCT00853723|P3|Participant Flow|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456381|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5 ms at 6 month.
456305|NCT00853723|P2|Participant Flow|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456306|NCT00853723|P1|Participant Flow|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456307|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
456308|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
456309|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
456310|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
456311|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
456312|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
456313|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
456314|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
456315|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
456316|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
456317|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
456318|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
456319|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
456320|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
456321|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
456322|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
456323|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
456324|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
456325|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456326|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456327|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456328|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456329|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456330|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456331|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456332|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456333|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456334|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456335|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456336|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456337|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456338|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456339|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456382|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at 6 month.
456340|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456341|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456342|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456343|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
456344|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
456345|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
456346|NCT00853723|E3|Reported Event|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
456347|NCT00853723|E2|Reported Event|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
456348|NCT00853723|E1|Reported Event|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
456349|NCT00853658|B4|Baseline|Total|Total of all reporting groups
456350|NCT00853658|B3|Baseline|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
456351|NCT00853658|B2|Baseline|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
456352|NCT00853658|B1|Baseline|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
456353|NCT00853658|P3|Participant Flow|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
456354|NCT00853658|P2|Participant Flow|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
456355|NCT00853658|P1|Participant Flow|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
456356|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
456357|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
456358|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
456359|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
456360|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
456361|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
456362|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
456363|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
456364|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
456365|NCT00853658|E3|Reported Event|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
456366|NCT00853658|E2|Reported Event|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
456367|NCT00853658|E1|Reported Event|Combination of Aliskiren and Enalapril|Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg
456368|NCT00853606|B1|Baseline|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
456369|NCT00853606|P1|Participant Flow|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
456370|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
456371|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
456372|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
456373|NCT00853606|E1|Reported Event|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
456374|NCT00853593|B1|Baseline|Model 4396 LV Lead|Subjects underwent Model 4396 left ventricular lead implant attempt
456375|NCT00853593|P1|Participant Flow|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
456376|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration R-wave amplitude at 6 month.
456377|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration pacing impedance at 6 month.
456384|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode threshold captured at 0.5ms at 6 month.
456385|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead and completed 1 month visit.
456386|NCT00853593|O1|Outcome|Model 4396 LV Lead|Model 4396 lead implant attempts.
456387|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
456388|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
456389|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
456390|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
456391|NCT00853593|O1|Outcome|Any Medtronic LV Lead (Attain Family Lead)|Subjects who underwent an implant attempt.
456392|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt.
456393|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt with successful CS cannulation.
456394|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
456395|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month.
456396|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode capture at 0.5ms at 1-month.
456397|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects who underwent a Model 4396 left ventricular lead implant attempt
456398|NCT00853593|E1|Reported Event|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
456399|NCT00853580|B3|Baseline|Total|Total of all reporting groups
456400|NCT00853580|B2|Baseline|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456401|NCT00853580|B1|Baseline|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456402|NCT00853580|P2|Participant Flow|Placebo|Look alike placebo pill with same dosing schedule as active lovastatin.
456403|NCT00853580|P1|Participant Flow|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456404|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456405|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456406|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456407|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456408|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456409|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456410|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456411|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456412|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456413|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456414|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456415|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456416|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456417|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456418|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456419|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456420|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456421|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456422|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456423|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456424|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456425|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456426|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456427|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456428|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456429|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456430|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456431|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456432|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456696|NCT00853333|P3|Participant Flow|Propofol|Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
456433|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456434|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456435|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456436|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456437|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456438|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456439|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456440|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456441|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456442|NCT00853580|O2|Outcome|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456443|NCT00853580|O1|Outcome|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456444|NCT00853580|E2|Reported Event|Placebo|Look alike placebo capsule with same dosing schedule as active lovastatin.
456445|NCT00853580|E1|Reported Event|Lovastatin|Oral lovastatin contained within in opaque capsules at a dose of 20mg a day (2 weeks) increased to a fixed dose of 40mg a day (14 weeks).
456446|NCT00853567|B4|Baseline|Total|Total of all reporting groups
456447|NCT00853567|B3|Baseline|Placebo|Placebo treatment
456448|NCT00853567|B2|Baseline|50 mg Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
456449|NCT00853567|B1|Baseline|25 g Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
456450|NCT00853567|P1|Participant Flow|All Arms|Proellex: 25 mg or 50 mg or placebo oral daily dose
456451|NCT00853567|O3|Outcome|Placebo|"Placebo treatment~placebo: Placebo"
456452|NCT00853567|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
456453|NCT00853567|O1|Outcome|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
456454|NCT00853567|E3|Reported Event|Placebo|"Placebo treatment~placebo: Placebo"
456455|NCT00853567|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
456456|NCT00853567|E1|Reported Event|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
456457|NCT00853489|B3|Baseline|Total|Total of all reporting groups
456458|NCT00853489|B2|Baseline|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
456459|NCT00853489|B1|Baseline|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
456460|NCT00853489|P2|Participant Flow|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
456461|NCT00853489|P1|Participant Flow|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
456462|NCT00853489|O2|Outcome|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
456463|NCT00853489|O1|Outcome|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
456464|NCT00853489|O2|Outcome|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
456465|NCT00853489|O1|Outcome|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
456466|NCT00853489|O2|Outcome|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
456467|NCT00853489|O1|Outcome|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
456468|NCT00853489|E2|Reported Event|Autogenous Iliac Crest Bone Graft|"Bone will be harvested from the iliac crest and placed in the bone defect.~Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice."
456697|NCT00853333|P2|Participant Flow|Midazolam|Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
458342|NCT00849693|B5|Baseline|Total|Total of all reporting groups
456469|NCT00853489|E1|Reported Event|Recombinant Bone Morphogenetic Protein 2|"The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical~recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft"
456470|NCT00853385|B6|Baseline|Total|Total of all reporting groups
456471|NCT00853385|B5|Baseline|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456472|NCT00853385|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456473|NCT00853385|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456474|NCT00853385|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456475|NCT00853385|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456476|NCT00853385|P5|Participant Flow|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456477|NCT00853385|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456478|NCT00853385|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456479|NCT00853385|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456480|NCT00853385|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456481|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456482|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456483|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456484|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456485|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456486|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456698|NCT00853333|P1|Participant Flow|Dexmedetomidine|Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
456699|NCT00853333|O3|Outcome|Propofol|
456700|NCT00853333|O2|Outcome|Midazolam|
456701|NCT00853333|O1|Outcome|Dexmedetomidine|
456702|NCT00853333|E3|Reported Event|Propofol|
456487|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456488|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456489|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456490|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456491|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456492|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456493|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456494|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456495|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456496|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456497|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456498|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456499|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456500|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456501|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456502|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456503|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456504|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456703|NCT00853333|E2|Reported Event|Midazolam|
456704|NCT00853333|E1|Reported Event|Dexmedetomidine|
456705|NCT00853307|B3|Baseline|Total|Total of all reporting groups
456739|NCT00853242|P4|Participant Flow|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456740|NCT00853242|P3|Participant Flow|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
461472|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
456505|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456506|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456507|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456508|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456509|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456510|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456511|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456512|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456513|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456514|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456515|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456516|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456517|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456518|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456519|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456520|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456521|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456522|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456706|NCT00853307|B2|Baseline|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456741|NCT00853242|P2|Participant Flow|Genz-644470 2.4 Grams Per Day (g/Day)|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456523|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456524|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456525|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456526|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456527|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456528|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456529|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456530|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456531|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456532|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456533|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456534|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456535|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456536|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456537|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456538|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456539|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456540|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456707|NCT00853307|B1|Baseline|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456742|NCT00853242|P1|Participant Flow|Placebo|Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
456541|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456542|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456543|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456544|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456545|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456546|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456547|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456548|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456549|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456550|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456551|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456552|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456553|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456554|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456555|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456556|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456557|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456558|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456708|NCT00853307|P2|Participant Flow|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456743|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456559|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456560|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456561|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456562|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456563|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456564|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456565|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456566|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456567|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456568|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456569|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456570|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456571|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456572|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456573|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456574|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456575|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456576|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456709|NCT00853307|P1|Participant Flow|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456744|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456577|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456578|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456579|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456580|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456581|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456582|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456583|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456584|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456585|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456586|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456587|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456588|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456589|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456590|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456591|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456592|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456593|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456594|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456710|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456745|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456595|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456596|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456597|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456598|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456599|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456600|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456601|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456602|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456603|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456604|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456605|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456606|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456607|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456608|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456609|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456610|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456611|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456612|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456711|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456746|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456613|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456614|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456615|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456616|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456617|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456618|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456619|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456620|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456621|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456622|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456623|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456624|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456625|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456626|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456627|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456628|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456629|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456630|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456631|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456632|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456633|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456634|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456635|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456636|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456637|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456638|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456639|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456640|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456641|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456642|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456643|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456644|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456645|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456646|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456647|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456648|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456649|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456650|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456651|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456712|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456747|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456652|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456653|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456654|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456655|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456656|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456657|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456658|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456659|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456660|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456661|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456662|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456663|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456664|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456665|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456666|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456667|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456668|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456669|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456713|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456748|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456670|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456671|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456672|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456673|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456674|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456675|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456676|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456677|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
456678|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456679|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456680|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456681|NCT00853385|E11|Reported Event|Adalimumab (Post Month 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
456682|NCT00853385|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
456683|NCT00853385|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
456684|NCT00853385|E8|Reported Event|Adalimumab (Month 3 to 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
456685|NCT00853385|E7|Reported Event|Placebo (Month 3 to 6)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456686|NCT00853385|E6|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
456687|NCT00853385|E5|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
456688|NCT00853385|E4|Reported Event|Adalimumab (Up To Month 3)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
456689|NCT00853385|E3|Reported Event|Placebo (Up To Month 3)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
456690|NCT00853385|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
456691|NCT00853385|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
456692|NCT00853333|B4|Baseline|Total|Total of all reporting groups
456714|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456715|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456716|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456717|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456718|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456719|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456720|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456721|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456722|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456723|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456724|NCT00853307|O2|Outcome|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456725|NCT00853307|O1|Outcome|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456726|NCT00853307|E2|Reported Event|Alisertib 50 mg (Platinum-Resistant)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
456727|NCT00853307|E1|Reported Event|Alisertib 50 mg (Platinum-Refractory)|Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
456728|NCT00853242|B8|Baseline|Total|Total of all reporting groups
456729|NCT00853242|B7|Baseline|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456730|NCT00853242|B6|Baseline|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456731|NCT00853242|B5|Baseline|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456732|NCT00853242|B4|Baseline|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456733|NCT00853242|B3|Baseline|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456734|NCT00853242|B2|Baseline|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456735|NCT00853242|B1|Baseline|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
456736|NCT00853242|P7|Participant Flow|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456737|NCT00853242|P6|Participant Flow|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456738|NCT00853242|P5|Participant Flow|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456749|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
456750|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456751|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456752|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456753|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456754|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456755|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456756|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
456757|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456758|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456759|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456760|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456761|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456762|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456763|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
456764|NCT00853242|O6|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456765|NCT00853242|O5|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456766|NCT00853242|O4|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456767|NCT00853242|O3|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456768|NCT00853242|O2|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456769|NCT00853242|O1|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456770|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456771|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456772|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456773|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
456774|NCT00853242|E7|Reported Event|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456775|NCT00853242|E6|Reported Event|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456776|NCT00853242|E5|Reported Event|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456777|NCT00853242|E4|Reported Event|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
456778|NCT00853242|E3|Reported Event|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
456779|NCT00853242|E2|Reported Event|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
456780|NCT00853242|E1|Reported Event|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
456781|NCT00853229|B3|Baseline|Total|Total of all reporting groups
456782|NCT00853229|B2|Baseline|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456783|NCT00853229|B1|Baseline|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456784|NCT00853229|P2|Participant Flow|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456785|NCT00853229|P1|Participant Flow|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456786|NCT00853229|O2|Outcome|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456787|NCT00853229|O1|Outcome|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456788|NCT00853229|E2|Reported Event|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456789|NCT00853229|E1|Reported Event|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
456790|NCT00853151|B5|Baseline|Total|Total of all reporting groups
456791|NCT00853151|B4|Baseline|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456792|NCT00853151|B3|Baseline|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456793|NCT00853151|B2|Baseline|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456794|NCT00853151|B1|Baseline|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456795|NCT00853151|P4|Participant Flow|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456796|NCT00853151|P3|Participant Flow|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456797|NCT00853151|P2|Participant Flow|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456798|NCT00853151|P1|Participant Flow|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456799|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456800|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456801|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456802|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456803|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456804|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456805|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456806|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456807|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456808|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456809|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456810|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456811|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456812|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456813|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456814|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456815|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456816|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456817|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456818|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456819|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456820|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456821|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456822|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456823|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456824|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456825|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456826|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456827|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456828|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456829|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456830|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456831|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456832|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456833|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456834|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456835|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456836|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456837|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456838|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456839|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456840|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456841|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456842|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456843|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456844|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456845|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456846|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456847|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456848|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456849|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456850|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456851|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456852|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456853|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
456854|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456855|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456856|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456857|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456858|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456859|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456860|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456861|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456862|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456863|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456864|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456865|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
456866|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456867|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456868|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456869|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456870|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456871|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456872|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456873|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456874|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456875|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456876|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456877|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456878|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456879|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456880|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456881|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456882|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456883|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456884|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456885|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456886|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456887|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456888|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456889|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456890|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456891|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456892|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456893|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456894|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456895|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456896|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456897|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456898|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456899|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456900|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456901|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456902|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456903|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456904|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456905|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456906|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456907|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456908|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456909|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456910|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456911|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456912|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456913|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456914|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456915|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456916|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456917|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456918|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456919|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456920|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456921|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456922|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456923|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456924|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456925|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456926|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456927|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456928|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456929|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456930|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456931|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456932|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456933|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456934|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456935|NCT00853151|E4|Reported Event|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456936|NCT00853151|E3|Reported Event|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
456937|NCT00853151|E2|Reported Event|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
456938|NCT00853151|E1|Reported Event|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
456939|NCT00853112|B8|Baseline|Total|Total of all reporting groups
456940|NCT00853112|B7|Baseline|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456941|NCT00853112|B6|Baseline|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456942|NCT00853112|B5|Baseline|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456943|NCT00853112|B4|Baseline|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456944|NCT00853112|B3|Baseline|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456945|NCT00853112|B2|Baseline|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456946|NCT00853112|B1|Baseline|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456947|NCT00853112|P7|Participant Flow|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456948|NCT00853112|P6|Participant Flow|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456949|NCT00853112|P5|Participant Flow|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456950|NCT00853112|P4|Participant Flow|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456951|NCT00853112|P3|Participant Flow|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456952|NCT00853112|P2|Participant Flow|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456953|NCT00853112|P1|Participant Flow|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456954|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456955|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456956|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456957|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456958|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456959|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456960|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456961|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456962|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456963|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456964|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456965|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456966|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456967|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456968|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456969|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456970|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456971|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456972|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456973|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456974|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456975|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456976|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456977|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456978|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456979|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456980|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456981|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456982|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456983|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456984|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456985|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456986|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456987|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456988|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456989|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456990|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456991|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456992|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456993|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456994|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
461473|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
456995|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
456996|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
456997|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
456998|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
456999|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457000|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457001|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457002|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457003|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457004|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457005|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457006|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457007|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457008|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457009|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457010|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457011|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457012|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457013|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457014|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457015|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457016|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457017|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457018|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457019|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457020|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457021|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457022|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457023|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457024|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457025|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457026|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457027|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457028|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457029|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457030|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457031|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457032|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457033|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457034|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457035|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457036|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457037|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457038|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457039|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457040|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457041|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457042|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457043|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457044|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457045|NCT00853112|O7|Outcome|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457046|NCT00853112|O6|Outcome|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457047|NCT00853112|O5|Outcome|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457048|NCT00853112|O4|Outcome|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457049|NCT00853112|O3|Outcome|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457050|NCT00853112|O2|Outcome|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457051|NCT00853112|O1|Outcome|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457052|NCT00853112|E7|Reported Event|Sildenafil|Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
457053|NCT00853112|E6|Reported Event|PF-00489791 20 mg|Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457054|NCT00853112|E5|Reported Event|PF-00489791 10 mg|Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457055|NCT00853112|E4|Reported Event|PF-00489791 4 mg|Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
457056|NCT00853112|E3|Reported Event|PF-00489791 2 mg|Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457057|NCT00853112|E2|Reported Event|PF-00489791 1 mg|Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
457058|NCT00853112|E1|Reported Event|Placebo|Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
457059|NCT00853099|B4|Baseline|Total|Total of all reporting groups
457060|NCT00853099|B3|Baseline|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457061|NCT00853099|B2|Baseline|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457062|NCT00853099|B1|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457063|NCT00853099|P4|Participant Flow|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
457114|NCT00853073|E2|Reported Event|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457064|NCT00853099|P3|Participant Flow|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
457065|NCT00853099|P2|Participant Flow|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
457066|NCT00853099|P1|Participant Flow|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
457067|NCT00853099|O1|Outcome|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
457068|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457069|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457070|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457071|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457072|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457073|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457074|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457075|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457076|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457077|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457078|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457079|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457080|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457081|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457082|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457083|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457084|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457085|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457086|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457087|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457088|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457089|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457090|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457091|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457092|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457093|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457115|NCT00853073|E1|Reported Event|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457094|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457095|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457096|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457097|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457098|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457099|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457100|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
457101|NCT00853099|E4|Reported Event|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
457102|NCT00853099|E3|Reported Event|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
457103|NCT00853099|E2|Reported Event|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
457104|NCT00853099|E1|Reported Event|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
457105|NCT00853073|B3|Baseline|Total|Total of all reporting groups
457106|NCT00853073|B2|Baseline|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457107|NCT00853073|B1|Baseline|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457108|NCT00853073|P2|Participant Flow|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457109|NCT00853073|P1|Participant Flow|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457110|NCT00853073|O2|Outcome|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457111|NCT00853073|O1|Outcome|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457112|NCT00853073|O2|Outcome|Treatment B (Balanced Salt Solution)|patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457113|NCT00853073|O1|Outcome|Treatment A (Bevacizumab)|patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
457206|NCT00852930|E1|Reported Event|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser~No adverse events during the study."
457116|NCT00853021|B1|Baseline|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
457117|NCT00853021|P1|Participant Flow|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
457118|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
457119|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
457120|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
457121|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
457122|NCT00853021|E1|Reported Event|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
457123|NCT00852995|B6|Baseline|Total|Total of all reporting groups
457124|NCT00852995|B5|Baseline|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457125|NCT00852995|B4|Baseline|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457126|NCT00852995|B3|Baseline|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457127|NCT00852995|B2|Baseline|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457128|NCT00852995|B1|Baseline|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457129|NCT00852995|P5|Participant Flow|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457130|NCT00852995|P4|Participant Flow|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457131|NCT00852995|P3|Participant Flow|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457132|NCT00852995|P2|Participant Flow|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457133|NCT00852995|P1|Participant Flow|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457134|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457135|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457136|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457137|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457138|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457139|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457140|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457207|NCT00852917|B5|Baseline|Total|Total of all reporting groups
457141|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457142|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457143|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457144|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457145|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457146|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457147|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457148|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457149|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457150|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457151|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457152|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457153|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457154|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457155|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457156|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457157|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457158|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457159|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457160|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457161|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457162|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457163|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457164|NCT00852995|O5|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457165|NCT00852995|O4|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457208|NCT00852917|B4|Baseline|4: Placebo|
457209|NCT00852917|B3|Baseline|3: Tramadol Once A Day 300mg|
457210|NCT00852917|B2|Baseline|2: Tramadol Once A Day 200mg|
457166|NCT00852995|O3|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457167|NCT00852995|O2|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457168|NCT00852995|O1|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457169|NCT00852995|E5|Reported Event|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457170|NCT00852995|E4|Reported Event|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457171|NCT00852995|E3|Reported Event|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457172|NCT00852995|E2|Reported Event|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
457173|NCT00852995|E1|Reported Event|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
457174|NCT00852969|B3|Baseline|Total|Total of all reporting groups
457175|NCT00852969|B2|Baseline|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
457176|NCT00852969|B1|Baseline|Niacin|Niacin : 1000 mg tablets once per day
457177|NCT00852969|P2|Participant Flow|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
457178|NCT00852969|P1|Participant Flow|Niacin|Niacin : 1000 mg tablets once per day
457179|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
457180|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
457181|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
457182|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
457183|NCT00852969|E2|Reported Event|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
457184|NCT00852969|E1|Reported Event|Niacin|Niacin : 1000 mg tablets once per day
457185|NCT00852930|B4|Baseline|Total|Total of all reporting groups
457186|NCT00852930|B3|Baseline|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
457187|NCT00852930|B2|Baseline|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
457188|NCT00852930|B1|Baseline|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
457189|NCT00852930|P3|Participant Flow|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
457190|NCT00852930|P2|Participant Flow|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
457191|NCT00852930|P1|Participant Flow|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
457192|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
457193|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage (mld)~manual lymphatic drainage: therapist administered massage therapy"
457194|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
457195|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
457196|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
457197|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
457198|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
457199|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
457200|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
457201|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
457202|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
457203|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
457204|NCT00852930|E3|Reported Event|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment~No adverse events during the study."
457205|NCT00852930|E2|Reported Event|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy~No adverse events during the study."
457253|NCT00852761|B2|Baseline|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
457254|NCT00852761|B1|Baseline|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
457255|NCT00852761|P2|Participant Flow|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
457256|NCT00852761|P1|Participant Flow|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
457257|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457258|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457259|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457260|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457261|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457262|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457263|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457264|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457265|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457266|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457267|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457268|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457269|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457270|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457271|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457272|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457273|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457274|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457275|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457276|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457277|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457278|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457279|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457280|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457281|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457282|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457283|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457284|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457285|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457286|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457287|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457288|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457289|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457290|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457291|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457292|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457293|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457294|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457295|NCT00852761|E2|Reported Event|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
457296|NCT00852761|E1|Reported Event|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
457297|NCT00852644|B1|Baseline|CyberKnife|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457298|NCT00852644|P6|Participant Flow|68 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457299|NCT00852644|P5|Participant Flow|62 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks a 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457300|NCT00852644|P4|Participant Flow|56 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457301|NCT00852644|P3|Participant Flow|68 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457302|NCT00852644|P2|Participant Flow|62 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457326|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
457303|NCT00852644|P1|Participant Flow|56 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457304|NCT00852644|O1|Outcome|CyberKnife|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457305|NCT00852644|O3|Outcome|68 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
457306|NCT00852644|O2|Outcome|62 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
457307|NCT00852644|O1|Outcome|56 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
457308|NCT00852644|O3|Outcome|68 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
457309|NCT00852644|O2|Outcome|62 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
457310|NCT00852644|O1|Outcome|56 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery~computed tomography: Standard CT scans~fludeoxyglucose F 18: standard doses with CT scans~hypofractionated radiation therapy: 4 doses over 2 weeks~stereotactic radiosurgery: CyberKnife radiosurgery"
457311|NCT00852644|O3|Outcome|68 Gray (LESS Than 3 Centimeter Cohort)|Dose 3 (68 gray), less than 3 centimeter cohort
457312|NCT00852644|O2|Outcome|62 Gray (LESS Less Than 3 Centimeter Cohort)|Dose 2 (62 gray), less than 3 centimeter cohort
457313|NCT00852644|O1|Outcome|56 Gray (LESS Than 3 Centimeter Cohort)|Dose 1 (56 gray), less than 3 centimeter cohort
457314|NCT00852644|O3|Outcome|68 Gray (LESS Than 3 Centimeter Cohort)|Dose 3 (68 gray), less than 3 centimeter cohort
457315|NCT00852644|O2|Outcome|62 Gray (LESS Less Than 3 Centimeter Cohort)|Dose 2 (62 gray), less than 3 centimeter cohort
457316|NCT00852644|O1|Outcome|56 Gray (LESS Than 3 Centimeter Cohort)|Dose 1 (56 gray), less than 3 centimeter cohort
457317|NCT00852644|E6|Reported Event|68 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457318|NCT00852644|E5|Reported Event|62 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457319|NCT00852644|E4|Reported Event|56 Gray (MORE Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457320|NCT00852644|E3|Reported Event|68 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457321|NCT00852644|E2|Reported Event|62 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457322|NCT00852644|E1|Reported Event|56 Gray (LESS Than 3 Centimeter Cohort)|"Intervention:~Procedure/Surgery: computed tomography Standard CT scans~Intervention:~Radiation: fludeoxyglucose F 18 standard doses with CT scans~Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray~Radiation: stereotactic radiosurgery CyberKnife radiosurgery"
457323|NCT00852631|B1|Baseline|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
457324|NCT00852631|P1|Participant Flow|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
457325|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
457327|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
457328|NCT00852631|E1|Reported Event|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
457329|NCT00852592|B3|Baseline|Total|Total of all reporting groups
457330|NCT00852592|B2|Baseline|Inactive Comparator|"inactive light unit~Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily"
457331|NCT00852592|B1|Baseline|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
457332|NCT00852592|P2|Participant Flow|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
457333|NCT00852592|P1|Participant Flow|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
457334|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
457335|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
457336|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
457337|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
457338|NCT00852592|E2|Reported Event|Inactive Comparator|inactive light unit Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
457339|NCT00852592|E1|Reported Event|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
457340|NCT00852540|B3|Baseline|Total|Total of all reporting groups
457341|NCT00852540|B2|Baseline|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457342|NCT00852540|B1|Baseline|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457343|NCT00852540|P2|Participant Flow|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457344|NCT00852540|P1|Participant Flow|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457345|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457346|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457347|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457348|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
461474|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
457349|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457350|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457351|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457352|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457353|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457354|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457355|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457356|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457357|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457358|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457359|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
461475|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
457360|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457361|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457362|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457363|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457364|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457365|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457366|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457367|NCT00852540|E2|Reported Event|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
457368|NCT00852540|E1|Reported Event|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
457369|NCT00852527|B1|Baseline|OEF/OIF Veterans|Operation Enduring Freedom /Operation Iraqi Freedom (OEF/OIF) Veterans seeking care at one of three VA Polytrauma Network Sites (PNS) who screen positive or negative for mild traumatic brain injury.
457370|NCT00852527|P2|Participant Flow|Negative Mild TBI|Participants who screened negative on the TBI Clinical Reminder Screen
457371|NCT00852527|P1|Participant Flow|Positive Mild TBI|Participants who screened positive on the TBI Clinical Reminder Screen
457372|NCT00852527|O2|Outcome|Veterans Assessed With the Structured TBI Diagnostic Interview|
457373|NCT00852527|O1|Outcome|Veterans Assessed With the Comprehensive TBI Evaluation|
457374|NCT00852527|E1|Reported Event|OEF/OIF Veterans|No adverse events.
457375|NCT00852475|B3|Baseline|Total|Total of all reporting groups
457376|NCT00852475|B2|Baseline|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
457377|NCT00852475|B1|Baseline|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
457378|NCT00852475|P2|Participant Flow|PUFA|"Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
457379|NCT00852475|P1|Participant Flow|MUFA|"Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program"
457380|NCT00852475|O2|Outcome|PUFA Arm|Assessment of FMD after 6 months of PUFA enrichment
457381|NCT00852475|O1|Outcome|MUFA Arm|Assessment of FMD after six months of MUFA enrichment
457382|NCT00852475|O2|Outcome|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
457383|NCT00852475|O1|Outcome|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
457384|NCT00852475|E2|Reported Event|PUFA|subjects received a diet enriched in PUFA
457385|NCT00852475|E1|Reported Event|MUFA|subjects received a diet enriched in MUFA
457386|NCT00852397|B4|Baseline|Total|Total of all reporting groups
457387|NCT00852397|B3|Baseline|Apixaban 5.0 mg BID|"Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
457388|NCT00852397|B2|Baseline|Apixaban 2.5 mg BID|"2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
457389|NCT00852397|B1|Baseline|Placebo|"Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
457390|NCT00852397|P3|Participant Flow|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457391|NCT00852397|P2|Participant Flow|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457392|NCT00852397|P1|Participant Flow|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457393|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457394|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457395|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457396|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457397|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457398|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457399|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457400|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457401|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457402|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457403|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457404|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457405|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457406|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457407|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457408|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457409|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457410|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457411|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457412|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
459214|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
457413|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457414|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457415|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457416|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457417|NCT00852397|E3|Reported Event|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457418|NCT00852397|E2|Reported Event|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457419|NCT00852397|E1|Reported Event|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
457420|NCT00852241|B1|Baseline|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Perlane: One syringe of Perlane® (1.0cc) will be used total for both tear trough areas."
457421|NCT00852241|P1|Participant Flow|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne and Perlane: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas."
457422|NCT00852241|O1|Outcome|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne and Perlane: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas."
457423|NCT00852241|E1|Reported Event|Restalyne and Perlane|"One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.~Restalyne and Perlane: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas."
457424|NCT00852137|B3|Baseline|Total|Total of all reporting groups
457425|NCT00852137|B2|Baseline|Vehicle|Vehicle gel once daily for 2 consecutive days
457426|NCT00852137|B1|Baseline|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457427|NCT00852137|P2|Participant Flow|Vehicle|Vehicle gel once daily for 2 consecutive days
457428|NCT00852137|P1|Participant Flow|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457429|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457430|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457431|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457432|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457433|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457434|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457435|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457436|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457437|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457438|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457439|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457440|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457441|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457442|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457443|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
457444|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457445|NCT00852137|E2|Reported Event|Vehicle|Vehicle gel once daily for 2 consecutive days
457446|NCT00852137|E1|Reported Event|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
457447|NCT00852124|B3|Baseline|Total|Total of all reporting groups
457448|NCT00852124|B2|Baseline|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
457449|NCT00852124|B1|Baseline|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
457450|NCT00852124|P2|Participant Flow|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
457451|NCT00852124|P1|Participant Flow|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
457452|NCT00852124|O1|Outcome|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
457453|NCT00852124|E2|Reported Event|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
457454|NCT00852124|E1|Reported Event|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
457466|NCT00851890|B4|Baseline|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
459215|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
457455|NCT00851903|B1|Baseline|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457456|NCT00851903|P1|Participant Flow|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457457|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457458|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457459|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457460|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457461|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457462|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457463|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457464|NCT00851903|E1|Reported Event|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
457465|NCT00851890|B5|Baseline|Total|Total of all reporting groups
457653|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
459216|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
457467|NCT00851890|B3|Baseline|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457468|NCT00851890|B2|Baseline|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457469|NCT00851890|B1|Baseline|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457470|NCT00851890|P4|Participant Flow|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457471|NCT00851890|P3|Participant Flow|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457472|NCT00851890|P2|Participant Flow|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457473|NCT00851890|P1|Participant Flow|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457474|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457475|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457476|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457477|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457478|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457479|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457480|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457481|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457482|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457483|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457484|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
461476|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
457485|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457486|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457487|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457488|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457489|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457490|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457491|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457492|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457493|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457494|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457495|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457496|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457497|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457498|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457499|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457500|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457501|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457502|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
459217|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
457503|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457504|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457505|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457506|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457507|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457508|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457509|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457510|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457511|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457512|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457513|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457514|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457515|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457516|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457517|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457518|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457519|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457520|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
459975|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
457521|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457522|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457523|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457524|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
457525|NCT00851890|E4|Reported Event|Placebo + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
457526|NCT00851890|E3|Reported Event|ABT-333 (1200 mg) Once Daily (QD) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
457527|NCT00851890|E2|Reported Event|ABT-333 (600 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
457528|NCT00851890|E1|Reported Event|ABT-333 (300 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
457529|NCT00851799|B4|Baseline|Total|Total of all reporting groups
457530|NCT00851799|B3|Baseline|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457531|NCT00851799|B2|Baseline|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457532|NCT00851799|B1|Baseline|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457533|NCT00851799|P3|Participant Flow|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457534|NCT00851799|P2|Participant Flow|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457535|NCT00851799|P1|Participant Flow|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457536|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457537|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457538|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457539|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457540|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457654|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
461477|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
457541|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457542|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457543|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457544|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457545|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457546|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457547|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457548|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457549|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457550|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457551|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457552|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457553|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457554|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457555|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457556|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457557|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457558|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457559|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457560|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457561|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457655|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457562|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457563|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457564|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457565|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457566|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457567|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457568|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457569|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457570|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457571|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457572|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457573|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457574|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457575|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457576|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457577|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457578|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457579|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457580|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457581|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457582|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457657|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457583|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457584|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457585|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457586|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457587|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457588|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457589|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457590|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457591|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457592|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457593|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457594|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457595|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457596|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457597|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457598|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457599|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457600|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457601|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457602|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457603|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457693|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457604|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457605|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457606|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457607|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457608|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457609|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457610|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457611|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457612|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457613|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457614|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457615|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457616|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457617|NCT00851799|E3|Reported Event|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
457618|NCT00851799|E2|Reported Event|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
457619|NCT00851799|E1|Reported Event|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
457620|NCT00851786|B3|Baseline|Total|Total of all reporting groups
457621|NCT00851786|B2|Baseline|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
457622|NCT00851786|B1|Baseline|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
457623|NCT00851786|P2|Participant Flow|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
457624|NCT00851786|P1|Participant Flow|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
457656|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
461478|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
457625|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
457626|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
457627|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
457628|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
457629|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
457630|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
457631|NCT00851786|E2|Reported Event|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
457632|NCT00851786|E1|Reported Event|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
457633|NCT00851747|B4|Baseline|Total|Total of all reporting groups
457634|NCT00851747|B3|Baseline|B PhosphatidylcholineDeoxycholate/Saline|Group B will receive saline injections on one side of the body and receive PhosphatidylcholineDeoxycholate injections on the contralateral side.
457635|NCT00851747|B2|Baseline|A Saline|Group A will serve as a control and will receive only injections of saline as a placebo.
457636|NCT00851747|B1|Baseline|C Phosphatidylcholine Deoxycholate|Phosphatidylcholine Deoxycholate Injections
457637|NCT00851747|P3|Participant Flow|C Phosphatidylcholine Deoxycholate|"Phosphatidylcholine Deoxycholate Injections~Group C will receive only study drug injections"
457638|NCT00851747|P2|Participant Flow|B PhosphatidylcholineDeoxycholate/Saliine|Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side
457639|NCT00851747|P1|Participant Flow|A Saline|Group A will serve as a control and will receive only injections of saline as a placebo.
457640|NCT00851747|O2|Outcome|Saline|"Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections~Saline: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections"
457641|NCT00851747|O1|Outcome|Subcutaneous Injections|"Phosphatidylcholine Deoxycholate Injections~Phosphatidylcholine Deoxycholate: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections~Saline: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections"
457642|NCT00851747|E3|Reported Event|B PhosphatidylcholineDeoxycholate/Saline|Group B will receive saline injections on one side of the body and receive PhosphatidylcholineDeoxycholate injections on the contralateral side.
457643|NCT00851747|E2|Reported Event|A Saline|Group A will serve as a control and will receive only injections of saline as a placebo.
457644|NCT00851747|E1|Reported Event|C Phosphatidylcholine Deoxycholate|Group C will receive only Phosphatidylcholine Deoxycholate injections
457645|NCT00851721|B3|Baseline|Total|Total of all reporting groups
457646|NCT00851721|B2|Baseline|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457647|NCT00851721|B1|Baseline|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
457648|NCT00851721|P2|Participant Flow|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457649|NCT00851721|P1|Participant Flow|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
457650|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457651|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457652|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457658|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457659|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457660|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457661|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457662|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457663|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457664|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457665|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457666|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457667|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457668|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457669|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457670|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457671|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457672|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457673|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457674|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457675|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457676|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457677|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457678|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457679|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457680|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457681|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457682|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457683|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457684|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457685|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457686|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457687|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457688|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457689|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457690|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457691|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457692|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457694|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457695|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457696|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457697|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457698|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457699|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457700|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457701|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457702|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457703|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457704|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457705|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457706|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457707|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457708|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457709|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457710|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457711|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457712|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457713|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457714|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457715|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457716|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457717|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457718|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457719|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457720|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457721|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457722|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457723|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457724|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457725|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
457726|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician~Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
457727|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457728|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457729|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician~Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
457730|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457731|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457732|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
457733|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
457734|NCT00851721|E2|Reported Event|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month ± 14 days prophylactic period
457735|NCT00851721|E1|Reported Event|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
457736|NCT00851682|B3|Baseline|Total|Total of all reporting groups
457737|NCT00851682|B2|Baseline|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457738|NCT00851682|B1|Baseline|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457739|NCT00851682|P2|Participant Flow|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457740|NCT00851682|P1|Participant Flow|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457741|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457742|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457743|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457744|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457745|NCT00851682|E2|Reported Event|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457746|NCT00851682|E1|Reported Event|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
457747|NCT00851643|B7|Baseline|Total|Total of all reporting groups
457775|NCT00851643|E2|Reported Event|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.
457748|NCT00851643|B6|Baseline|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457749|NCT00851643|B5|Baseline|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457750|NCT00851643|B4|Baseline|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457751|NCT00851643|B3|Baseline|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457752|NCT00851643|B2|Baseline|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457753|NCT00851643|B1|Baseline|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457754|NCT00851643|P6|Participant Flow|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457755|NCT00851643|P5|Participant Flow|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457756|NCT00851643|P4|Participant Flow|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457757|NCT00851643|P3|Participant Flow|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457758|NCT00851643|P2|Participant Flow|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457759|NCT00851643|P1|Participant Flow|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
457760|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
457761|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
457762|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
457763|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
457764|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
457765|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
457766|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
457767|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
457768|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
457769|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
457770|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
457771|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
457772|NCT00851643|E5|Reported Event|Octavalent With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.
457773|NCT00851643|E4|Reported Event|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.
457774|NCT00851643|E3|Reported Event|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.
457776|NCT00851643|E1|Reported Event|qHPV (GARDASIL™) - Phase A and Phase B Controls|Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.
457777|NCT00851630|B3|Baseline|Total|Total of all reporting groups
457778|NCT00851630|B2|Baseline|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
457779|NCT00851630|B1|Baseline|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
457780|NCT00851630|P2|Participant Flow|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
457781|NCT00851630|P1|Participant Flow|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
457782|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
457783|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
457784|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
457785|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
457786|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
457787|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
457788|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
457789|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
457790|NCT00851630|E2|Reported Event|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
457791|NCT00851630|E1|Reported Event|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
457792|NCT00851591|B3|Baseline|Total|Total of all reporting groups
457793|NCT00851591|B2|Baseline|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
457794|NCT00851591|B1|Baseline|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
457795|NCT00851591|P2|Participant Flow|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
457796|NCT00851591|P1|Participant Flow|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
457797|NCT00851591|O2|Outcome|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
457798|NCT00851591|O1|Outcome|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
457799|NCT00851591|E2|Reported Event|2 Group Scheduled to Receive Placebo|Psyllium Category: These patients were scheduled to take 3 capsules 3 times a day with a full glass of water and each dose was for 7 days.
457800|NCT00851591|E1|Reported Event|1 Group Scheduled to Receive Fenugreek|Fenugreek Category: These patients were scheduled to take 3 capsules 3 times per day with a full glass of water and each dose was for 7 days.
457801|NCT00851552|B1|Baseline|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
457802|NCT00851552|P1|Participant Flow|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
457803|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
457804|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
457805|NCT00851552|E1|Reported Event|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
457806|NCT00851409|B1|Baseline|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
457807|NCT00851409|P1|Participant Flow|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
457808|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
457936|NCT00850759|E3|Reported Event|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
457809|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
457810|NCT00851409|E1|Reported Event|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
457811|NCT00851318|B5|Baseline|Total|Total of all reporting groups
457812|NCT00851318|B4|Baseline|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457813|NCT00851318|B3|Baseline|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457814|NCT00851318|B2|Baseline|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457815|NCT00851318|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457816|NCT00851318|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457817|NCT00851318|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457818|NCT00851318|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457819|NCT00851318|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457820|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457821|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457822|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457823|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457824|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457825|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457826|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457827|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457828|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457829|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457830|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457853|NCT00851253|B2|Baseline|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457831|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457832|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457833|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457834|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457835|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457836|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457837|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457838|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457839|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457840|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457841|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457842|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457843|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457844|NCT00851318|E4|Reported Event|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457845|NCT00851318|E3|Reported Event|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457846|NCT00851318|E2|Reported Event|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457847|NCT00851318|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
457848|NCT00851279|B1|Baseline|Magnetic Irrigated Ablation Catheter|Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
457849|NCT00851279|P1|Participant Flow|Magnetic Irrigated Ablation Catheter|Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
457850|NCT00851279|O1|Outcome|Magnetic Irrigated Ablation Catheter|Either the transseptal or transaortic approach was employed to gain access for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with RMN (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
457851|NCT00851279|E1|Reported Event|Magnetic Irrigated Ablation Catheter|"Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system~There were no adverse events associated with the procedure and within a 7 to 10 days post-doc window"
457852|NCT00851253|B3|Baseline|Total|Total of all reporting groups
457894|NCT00850993|B1|Baseline|Placebo|Saline : Normal saline (0.9%) solution
458120|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
457854|NCT00851253|B1|Baseline|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457855|NCT00851253|P2|Participant Flow|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457856|NCT00851253|P1|Participant Flow|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457857|NCT00851253|O2|Outcome|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457858|NCT00851253|O1|Outcome|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457859|NCT00851253|O2|Outcome|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457860|NCT00851253|O1|Outcome|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457861|NCT00851253|E2|Reported Event|Group 2 (CK SRS Salvage Therapy)|"Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457862|NCT00851253|E1|Reported Event|Group 1 (CK SRS Boost Therapy)|"Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.~stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses"
457863|NCT00851084|B3|Baseline|Total|Total of all reporting groups
457864|NCT00851084|B2|Baseline|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457865|NCT00851084|B1|Baseline|mFOLFOX6 Only|modified FOLFOX6
457866|NCT00851084|P2|Participant Flow|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457867|NCT00851084|P1|Participant Flow|mFOLFOX6 Only|modified FOLFOX6
457868|NCT00851084|O2|Outcome|Positive|Positive antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
457869|NCT00851084|O1|Outcome|Negative or Missing|Negative or missing antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
457870|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457871|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
457872|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457873|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
457874|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457875|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
457876|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457877|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
457878|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457879|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
457880|NCT00851084|E2|Reported Event|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
457881|NCT00851084|E1|Reported Event|mFOLFOX6 Only|modified FOLFOX6
457882|NCT00851006|B1|Baseline|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Inclusion criteria were: females 13–18 years of age with a primary diagnosis of MDD. All participants were Caucasian females.
457883|NCT00851006|P2|Participant Flow|Healthy Control Group|Only 31P MRS brain scans were used from healthy individuals. HC group were not treated.
457884|NCT00851006|P1|Participant Flow|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks.
457885|NCT00851006|O2|Outcome|Healthy Control Group|6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
457886|NCT00851006|O1|Outcome|Open Label Creatine Treatment|"MDD participants' 31P MRS scans were performed prior to the first dose of creatine, and repeated following 8 weeks of treatment.~Participants were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks."
457887|NCT00851006|O1|Outcome|Open Label Creatine Treatment|The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.
457888|NCT00851006|E2|Reported Event|Healthy Control Group|Healthy Control Group did not go through treatment. HC 31P MRS scans were only used for the study.
457889|NCT00851006|E1|Reported Event|Open Label Creatine Treatment|There were no serious adverse events were experienced in this study.
457890|NCT00850993|B5|Baseline|Total|Total of all reporting groups
457891|NCT00850993|B4|Baseline|Stanate® 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457892|NCT00850993|B3|Baseline|Stanate® 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457893|NCT00850993|B2|Baseline|Stanate® 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457895|NCT00850993|P4|Participant Flow|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457896|NCT00850993|P3|Participant Flow|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457897|NCT00850993|P2|Participant Flow|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457898|NCT00850993|P1|Participant Flow|Placebo|Saline : Normal saline (0.9%) solution
457899|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457900|NCT00850993|O3|Outcome|Stannsoporfin3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457901|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457902|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
457903|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457904|NCT00850993|O3|Outcome|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457905|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457906|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
457907|NCT00850993|E4|Reported Event|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457908|NCT00850993|E3|Reported Event|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457909|NCT00850993|E2|Reported Event|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
457910|NCT00850993|E1|Reported Event|Placebo|Saline : Normal saline (0.9%) solution
457911|NCT00850889|B1|Baseline|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
457912|NCT00850889|P1|Participant Flow|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
457913|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
457914|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
457915|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
457916|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
457917|NCT00850889|O1|Outcome|Total Study Participants|
457918|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
457919|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
457920|NCT00850889|E2|Reported Event|Restylane|
457921|NCT00850889|E1|Reported Event|Juvederm Ultra Injectable Gel With Lidocaine|
457922|NCT00850759|B5|Baseline|Total|Total of all reporting groups
457923|NCT00850759|B4|Baseline|No-contact Control|no-contact control group.
457924|NCT00850759|B3|Baseline|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
457925|NCT00850759|B2|Baseline|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
457926|NCT00850759|B1|Baseline|Virtual Reality|street-crossing training in a virtual pedestrian environment
457927|NCT00850759|P4|Participant Flow|No-contact Control|no-contact control group.
457928|NCT00850759|P3|Participant Flow|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
457929|NCT00850759|P2|Participant Flow|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
457930|NCT00850759|P1|Participant Flow|Virtual Reality|street-crossing training in a virtual pedestrian environment
457931|NCT00850759|O4|Outcome|No-contact Control|no-contact control group.
457932|NCT00850759|O3|Outcome|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
457933|NCT00850759|O2|Outcome|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
457934|NCT00850759|O1|Outcome|Virtual Reality|street-crossing training in a virtual pedestrian environment
457937|NCT00850759|E2|Reported Event|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
457938|NCT00850759|E1|Reported Event|Virtual Reality|street-crossing training in a virtual pedestrian environment
457939|NCT00850720|B1|Baseline|Cardiac Surgery|Infants with congenital defects.
457940|NCT00850720|P1|Participant Flow|Cardiac Surgery|Infants with congenital defects.
457941|NCT00850720|O1|Outcome|Cardiac Surgery|Infants with congenital defects.
457942|NCT00850720|E1|Reported Event|Cardiac Surgery|Infants with congenital defects.
457943|NCT00850642|B3|Baseline|Total|Total of all reporting groups
457944|NCT00850642|B2|Baseline|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally, once daily for 12-days.
457945|NCT00850642|B1|Baseline|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days.
457946|NCT00850642|P2|Participant Flow|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 milligram (mg), orally once daily for 12-days.
457947|NCT00850642|P1|Participant Flow|Placebo|The eligible participants in this arm were administered with matching placebo, orally, once daily for 12-days.
457948|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457949|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457950|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457951|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457952|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457953|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457954|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457955|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457956|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457957|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457958|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457959|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457960|NCT00850642|O1|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457961|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received 100 mg GSK2190915, once daily for 12-days.
457962|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, once daily for 12-days.
457963|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457964|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457965|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457966|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457967|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days.
457968|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days.
457969|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457970|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457971|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days.
457972|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days.
457973|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days.
457974|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days.
457975|NCT00850642|O2|Outcome|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
457976|NCT00850642|O1|Outcome|Placebo|The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
457977|NCT00850642|E2|Reported Event|GSK2190915|The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days.
457978|NCT00850642|E1|Reported Event|Placebo|The eligible participants in this arm were administered with matching placebo, orally, once daily for 12-days.
457979|NCT00850603|B6|Baseline|Total|Total of all reporting groups
457980|NCT00850603|B5|Baseline|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
457981|NCT00850603|B4|Baseline|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
457982|NCT00850603|B3|Baseline|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
457983|NCT00850603|B2|Baseline|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
457984|NCT00850603|B1|Baseline|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
457985|NCT00850603|P5|Participant Flow|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
457986|NCT00850603|P4|Participant Flow|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
461479|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
457987|NCT00850603|P3|Participant Flow|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
457988|NCT00850603|P2|Participant Flow|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
457989|NCT00850603|P1|Participant Flow|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
457990|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
457991|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
457992|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
457993|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
457994|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
457995|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
457996|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
457997|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
457998|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
457999|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
458000|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
458001|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
458002|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
458003|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
458004|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
458005|NCT00850603|E5|Reported Event|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
458006|NCT00850603|E4|Reported Event|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
458007|NCT00850603|E3|Reported Event|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
458008|NCT00850603|E2|Reported Event|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
458009|NCT00850603|E1|Reported Event|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
458010|NCT00850564|B1|Baseline|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
458011|NCT00850564|P1|Participant Flow|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
458012|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
458013|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
458014|NCT00850564|E1|Reported Event|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
458015|NCT00850538|B1|Baseline|Enrolled|"Subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
458016|NCT00850538|P1|Participant Flow|Enrolled|"Inclusion Criteria:~- subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
458017|NCT00850538|O1|Outcome|Specimens|Viable specimens for genetic analysis
458018|NCT00850538|E1|Reported Event|Enrolled|subjects having primary knee replacement surgery
458019|NCT00850499|B3|Baseline|Total|Total of all reporting groups
458020|NCT00850499|B2|Baseline|Rituximab + Fludarabine|
458021|NCT00850499|B1|Baseline|Velcade + Fludarabine|
458022|NCT00850499|P2|Participant Flow|Rituximab + Fludarabine|
458023|NCT00850499|P1|Participant Flow|Velcade + Fludarabine|
458024|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
458025|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
458026|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
458027|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
458028|NCT00850499|E2|Reported Event|Rituximab + Fludarabine|
458029|NCT00850499|E1|Reported Event|Velcade + Fludarabine|
458030|NCT00850460|B3|Baseline|Total|Total of all reporting groups
458031|NCT00850460|B2|Baseline|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
458032|NCT00850460|B1|Baseline|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
458033|NCT00850460|P2|Participant Flow|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
458034|NCT00850460|P1|Participant Flow|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
458035|NCT00850460|O2|Outcome|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
459976|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
458036|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
458037|NCT00850460|O2|Outcome|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
458038|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
458039|NCT00850460|E2|Reported Event|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
458040|NCT00850460|E1|Reported Event|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
458041|NCT00850421|B1|Baseline|Botulinum Toxin Type A|
458042|NCT00850421|P1|Participant Flow|Botulinum Toxin Type A|
458043|NCT00850421|O1|Outcome|Botulinum Toxin Type A|
458044|NCT00850421|E1|Reported Event|Botulinum Toxin Type A|
458045|NCT00850395|B1|Baseline|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458046|NCT00850395|P1|Participant Flow|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458047|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458048|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458049|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458050|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458051|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458052|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458053|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458054|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458055|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458056|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458057|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458058|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458059|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458060|NCT00850395|E1|Reported Event|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
458061|NCT00850343|B5|Baseline|Total|Total of all reporting groups
458062|NCT00850343|B4|Baseline|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458063|NCT00850343|B3|Baseline|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458064|NCT00850343|B2|Baseline|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458065|NCT00850343|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458066|NCT00850343|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458191|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458067|NCT00850343|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458068|NCT00850343|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458069|NCT00850343|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458070|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458071|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458072|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458073|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458074|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458075|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458076|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458077|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458078|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458079|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458080|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458081|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458082|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458083|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458084|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458085|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458086|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458087|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458088|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458150|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458089|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458090|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458091|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458092|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458093|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458094|NCT00850343|E4|Reported Event|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458095|NCT00850343|E3|Reported Event|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458096|NCT00850343|E2|Reported Event|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458097|NCT00850343|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
458098|NCT00850200|B1|Baseline|Proton Therapy Plan Compared to IMRT and Conventional RT|Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one).
458099|NCT00850200|P1|Participant Flow|Optimal Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
458100|NCT00850200|O3|Outcome|Intensity Modulated Radiation Plan|Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
458101|NCT00850200|O2|Outcome|Conventional Photon Radiation Plan|Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
458102|NCT00850200|O1|Outcome|Proton Radiation Plan|Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
458103|NCT00850200|E1|Reported Event|Superior Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
458104|NCT00850174|B3|Baseline|Total|Total of all reporting groups
458105|NCT00850174|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
458106|NCT00850174|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
458107|NCT00850174|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
458108|NCT00850174|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
458109|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458110|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458111|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458112|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458113|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458114|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458115|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458116|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458117|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458118|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458119|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458121|NCT00850135|B1|Baseline|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
458122|NCT00850135|P1|Participant Flow|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
458123|NCT00850135|O2|Outcome|Participants With AUC 130 >22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
458124|NCT00850135|O1|Outcome|Participants With AUC 130 <= 22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
458125|NCT00850135|O1|Outcome|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
458126|NCT00850135|E1|Reported Event|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
458127|NCT00850096|B3|Baseline|Total|Total of all reporting groups
458128|NCT00850096|B2|Baseline|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
458129|NCT00850096|B1|Baseline|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
458130|NCT00850096|P2|Participant Flow|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
458131|NCT00850096|P1|Participant Flow|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
458132|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
458133|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
458134|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
458135|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
458136|NCT00850096|E2|Reported Event|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
458137|NCT00850096|E1|Reported Event|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
458138|NCT00850070|B3|Baseline|Total|Total of all reporting groups
458139|NCT00850070|B2|Baseline|Placebo|sugar pill
458140|NCT00850070|B1|Baseline|Sapropterin|tetrahydrobiopterin (BH4)
458141|NCT00850070|P2|Participant Flow|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458142|NCT00850070|P1|Participant Flow|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458143|NCT00850070|O2|Outcome|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458144|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458145|NCT00850070|O2|Outcome|Placebo|sugar pill
458146|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
458147|NCT00850070|O2|Outcome|Placebo|sugar pill
458148|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
458149|NCT00850070|O2|Outcome|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458190|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
458151|NCT00850070|O2|Outcome|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458152|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
458153|NCT00850070|O2|Outcome|Placebo, Matching Active Drug|"The placebo was supplied as a 100 mg tablet, and dosage was based on 20 mg/kg/d, rounding to the nearest 100 mg. Most subjects crushed the tablets and administered it in liquid or a food to mask the taste. Subjects took the same dose daily for 16 weeks.~Placebo: Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks."
458154|NCT00850070|O1|Outcome|Sapropterin, 100 mg Capsules|"Sapropterin was supplied as a 100 mg tablet and dosage was based on 20 mg/kg/d, rounding to the nearest 100 mg. Most subjects crushed the tablets and administered it in liquid or a food to mask the taste. Subjects took the same dose daily for 16 weeks.~sapropterin: Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks"
458155|NCT00850070|O2|Outcome|Placebo|sugar pill
458156|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
458157|NCT00850070|O2|Outcome|Placebo|sugar pill
458158|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
458159|NCT00850070|O2|Outcome|Placebo|sugar pill
458160|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
458161|NCT00850070|O2|Outcome|Placebo|sugar pill
458162|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
458163|NCT00850070|E2|Reported Event|Placebo|sugar pill
458164|NCT00850070|E1|Reported Event|Sapropterin|sapropterin 20 mg/kg/day
458165|NCT00850031|B1|Baseline|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: Inlay implanted in cornea for improvement of near vision"
458166|NCT00850031|P1|Participant Flow|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
458167|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
458168|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
458169|NCT00850031|E1|Reported Event|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
458170|NCT00849940|B1|Baseline|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458171|NCT00849940|P1|Participant Flow|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458172|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458173|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458174|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458175|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458176|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458177|NCT00849940|E1|Reported Event|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
458178|NCT00849901|B4|Baseline|Total|Total of all reporting groups
458179|NCT00849901|B3|Baseline|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458180|NCT00849901|B2|Baseline|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458181|NCT00849901|B1|Baseline|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458182|NCT00849901|P3|Participant Flow|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458183|NCT00849901|P2|Participant Flow|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458184|NCT00849901|P1|Participant Flow|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458185|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458186|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458187|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458188|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
458189|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
458236|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458192|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458193|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458194|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
458195|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
458196|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
458197|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458198|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458199|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458200|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
458201|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
458202|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
458203|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458204|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458205|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458206|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
458207|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
458208|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
458209|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458210|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458211|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458212|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
458213|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
458214|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
458215|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458216|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
458217|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
458218|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
458219|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
458220|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
458221|NCT00849901|E6|Reported Event|Placebo/Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458222|NCT00849901|E5|Reported Event|Fluoxetine - Extension|Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section).
458223|NCT00849901|E4|Reported Event|Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
458224|NCT00849901|E3|Reported Event|Placebo - Acute|Received placebo PO, QD during acute treatment phase
458225|NCT00849901|E2|Reported Event|Fluoxetine - Acute|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
458226|NCT00849901|E1|Reported Event|Duloxetine - Acute|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
458227|NCT00849875|B4|Baseline|Total|Total of all reporting groups
458228|NCT00849875|B3|Baseline|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458229|NCT00849875|B2|Baseline|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458230|NCT00849875|B1|Baseline|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458231|NCT00849875|P1|Participant Flow|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458232|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458233|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458234|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458235|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458237|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458238|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458239|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458240|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458241|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458242|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458243|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458244|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458245|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458246|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458247|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458248|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458249|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458250|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458251|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458252|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458253|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458254|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458255|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458256|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458257|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458258|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458259|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458260|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458261|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458262|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458263|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458264|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458265|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458266|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458267|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458268|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458269|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458270|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458271|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458339|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458340|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458272|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458273|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458274|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458275|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458276|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458277|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458278|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458279|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458280|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458281|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458282|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458283|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening
458284|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458285|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458286|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458287|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458288|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458289|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458290|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458291|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458292|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458293|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458294|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458295|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458296|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458297|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458298|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458299|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening
458300|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458301|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458302|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458303|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458304|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458305|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
458306|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458307|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458308|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458309|NCT00849875|E1|Reported Event|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
458310|NCT00849862|B3|Baseline|Total|Total of all reporting groups
458311|NCT00849862|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
458312|NCT00849862|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
458313|NCT00849862|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
458314|NCT00849862|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
458315|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
458316|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
458317|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
458318|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
458319|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
458320|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
458321|NCT00849810|B1|Baseline|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
458322|NCT00849810|P1|Participant Flow|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
458323|NCT00849810|O1|Outcome|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
458324|NCT00849810|E1|Reported Event|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
458325|NCT00849797|B3|Baseline|Total|Total of all reporting groups
458326|NCT00849797|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
458327|NCT00849797|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
458328|NCT00849797|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
458329|NCT00849797|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
458330|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458331|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458332|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458333|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458334|NCT00849797|O2|Outcome|Trileptal|Trileptal® 600 mg Tablet (reference) dosed in either period
458335|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458336|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458337|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
458338|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
458343|NCT00849693|B4|Baseline|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458344|NCT00849693|B3|Baseline|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
458345|NCT00849693|B2|Baseline|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458346|NCT00849693|B1|Baseline|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458347|NCT00849693|P4|Participant Flow|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458348|NCT00849693|P3|Participant Flow|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
458349|NCT00849693|P2|Participant Flow|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458350|NCT00849693|P1|Participant Flow|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458351|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458352|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
458353|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458354|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458355|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
458356|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
458357|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
458358|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
458359|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458360|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
458361|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458362|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458363|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
458364|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
458365|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
458366|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
458367|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458368|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
458369|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458370|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458371|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
458372|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
458373|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
458374|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
458375|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458376|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
459105|NCT00848185|E2|Reported Event|GnRH Antagonist Triptorelin Trigger|GnRH antagonist protocol and triptorelin trigger
458377|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458378|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458379|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
458380|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
458381|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
458382|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
458383|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458384|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
458385|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458386|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458387|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
458388|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
458389|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
458390|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
458391|NCT00849693|O3|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
458392|NCT00849693|O2|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
458393|NCT00849693|O1|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
458394|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458395|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
458396|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458397|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
458398|NCT00849693|O2|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
458399|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
458400|NCT00849693|E8|Reported Event|Placebo/Duloxetine - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
458401|NCT00849693|E7|Reported Event|Fluoxetine 20 mg - Extension|Fluoxetine 20-40 mg, orally, once daily for 6 months
458402|NCT00849693|E6|Reported Event|Duloxetine 30 mg - Extension|"Duloxetine 60-120 mg , orally, once daily for 6 months~One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase [see Participant Flow section])."
458403|NCT00849693|E5|Reported Event|Duloxetine 60 mg - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
458404|NCT00849693|E4|Reported Event|Placebo - Acute|Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
458405|NCT00849693|E3|Reported Event|Fluoxetine 20 mg - Acute|Fluoxetine 20 mg, orally, once daily for 10 weeks
458406|NCT00849693|E2|Reported Event|Duloxetine 30 mg - Acute|Duloxetine 30 mg, orally, once daily for 10 weeks
458407|NCT00849693|E1|Reported Event|Duloxetine 60 mg - Acute|Duloxetine 60 mg, orally, once daily for 10 weeks
458408|NCT00849680|B9|Baseline|Total|Total of all reporting groups
458409|NCT00849680|B8|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
458410|NCT00849680|B7|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
458411|NCT00849680|B6|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
458412|NCT00849680|B5|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
458413|NCT00849680|B4|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
458414|NCT00849680|B3|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
458415|NCT00849680|B2|Baseline|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
458416|NCT00849680|B1|Baseline|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
458417|NCT00849680|P8|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
458418|NCT00849680|P7|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
458419|NCT00849680|P6|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
458420|NCT00849680|P5|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
458421|NCT00849680|P4|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
458422|NCT00849680|P3|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
458423|NCT00849680|P2|Participant Flow|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
458424|NCT00849680|P1|Participant Flow|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
458425|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
458426|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
458427|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
458428|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
458429|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
458430|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
458431|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
458432|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
458433|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
458434|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
458435|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
458436|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
458437|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
458438|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
458439|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
458440|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
458441|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
458442|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
458443|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
458444|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
458445|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
458446|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
458447|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
458448|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
458449|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
458450|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
459157|NCT00848081|E1|Reported Event|Placebo|Placebo by mouth once daily for 12 weeks
458451|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
458452|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
458453|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
458454|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
458455|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
458456|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
458457|NCT00849680|E8|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)|
458458|NCT00849680|E7|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)|
458459|NCT00849680|E6|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)|
458460|NCT00849680|E5|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)|
458461|NCT00849680|E4|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)|
458462|NCT00849680|E3|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)|
458463|NCT00849680|E2|Reported Event|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)|
458464|NCT00849680|E1|Reported Event|Placebo|
458465|NCT00849524|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
458466|NCT00849524|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
458467|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
458468|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
458469|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
458470|NCT00849524|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
458471|NCT00849485|B3|Baseline|Total|Total of all reporting groups
458472|NCT00849485|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
458473|NCT00849485|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
458474|NCT00849485|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
458475|NCT00849485|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
458476|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
458477|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
458478|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
458479|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
458480|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
458481|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
458482|NCT00849472|B1|Baseline|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458497|NCT00849381|P1|Participant Flow|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
458498|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
458499|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
458483|NCT00849472|P1|Participant Flow|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants (par.) were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458484|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458485|NCT00849472|O1|Outcome|Overall Study Arm|
458486|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458487|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458488|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458489|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458490|NCT00849472|O1|Outcome|Overall Study Arm|
458491|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458492|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458493|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458494|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458495|NCT00849472|E1|Reported Event|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
458496|NCT00849381|B1|Baseline|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
458500|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
458501|NCT00849381|E1|Reported Event|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
458502|NCT00849290|B1|Baseline|APC8015F|
458503|NCT00849290|P1|Participant Flow|APC8015F|APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.
458504|NCT00849290|O1|Outcome|APC8015F|
458505|NCT00849290|E1|Reported Event|APC8015F|
458506|NCT00849251|B1|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor)|"Patients receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
458507|NCT00849251|P2|Participant Flow|Newly Diagnosed Disease (Cohort II)|"Patients with newly diagnosed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
458508|NCT00849251|P1|Participant Flow|Relapsed Disease (Cohort I)|"Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
458509|NCT00849251|O1|Outcome|Relapsed Disease (Cohort I)|"Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
458510|NCT00849251|O1|Outcome|Newly Diagnosed Patients|"Patients with newly diagnosed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
458511|NCT00849251|O1|Outcome|Relapsed Disease|"Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
458512|NCT00849251|E1|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor)|"Patients receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Given IV or PO~pegylated liposomal doxorubicin hydrochloride: Given IV~bortezomib: Given IV~dexamethasone: Given IV or PO"
458513|NCT00849212|B1|Baseline|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
458514|NCT00849212|P1|Participant Flow|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
458515|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
458516|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
458626|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
459158|NCT00848042|B4|Baseline|Total|Total of all reporting groups
458517|NCT00849212|E1|Reported Event|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
458518|NCT00849186|B1|Baseline|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
458519|NCT00849186|P1|Participant Flow|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
458520|NCT00849186|O1|Outcome|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
458521|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
458522|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
458523|NCT00849186|E1|Reported Event|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
458524|NCT00849147|B1|Baseline|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458525|NCT00849147|P1|Participant Flow|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458526|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458527|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458528|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458529|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458530|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458531|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458532|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458533|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458534|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458535|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458536|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458537|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458538|NCT00849147|E1|Reported Event|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
458539|NCT00849121|B3|Baseline|Total|Total of all reporting groups
458540|NCT00849121|B2|Baseline|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
458541|NCT00849121|B1|Baseline|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
458542|NCT00849121|P2|Participant Flow|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
458543|NCT00849121|P1|Participant Flow|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally (i.d.) biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally every 3 months until radiographic disease progression"
458544|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
458598|NCT00849017|O2|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458545|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
458546|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
458547|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
458548|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
458549|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
458550|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
458551|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
458552|NCT00849121|E2|Reported Event|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
458553|NCT00849121|E1|Reported Event|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
458554|NCT00849108|B4|Baseline|Total|Total of all reporting groups
458555|NCT00849108|B3|Baseline|Cohort 2: Efficacy Exercise Stress|"Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at exercise stress over a 1-day period.~For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose."
458556|NCT00849108|B2|Baseline|Cohort 2: Pharm Stress|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at pharmacologic stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose.
458557|NCT00849108|B1|Baseline|Cohort 1 Dose Ranging and Dose Interval|Patients received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
458558|NCT00849108|P2|Participant Flow|Cohort 2 Preliminary Efficacy Pharmacologic Stress|Patients received 2 injections of BMS747158: 1 at rest and 1 at Pharmacologic stress, over a 1-day period.
458559|NCT00849108|P1|Participant Flow|Cohort 1 Dose Ranging and Dose Interval|Patients received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
458560|NCT00849108|O1|Outcome|Cohort 2: Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
458561|NCT00849108|O1|Outcome|Cohort 1 Dose Ranging and Dose Interval|Subjects received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
458562|NCT00849108|O1|Outcome|Cohort 2 Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
458563|NCT00849108|O1|Outcome|Cohort 1: Dose Acquistion Time Product|Subjects received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
458564|NCT00849108|E2|Reported Event|Cohort 2: Efficacy in Pharm Stress|"Patients receive 2 IV injections of BMS747158:at rest and stress~For the Pharmacologic (Adenosine) Stress:~Doses range at rest between 2.9 and 3.4 mCi.~Dose range at stress between 5.8 and 8.2 mCi (factor of 2.0 to 2.4 greater than the rest dose).~For the Exercise Stress:~Doses at rest were to range between 1.7 and 2.0 mCi.~Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi."
458565|NCT00849108|E1|Reported Event|Cohort 1: Dose Range and Dose Interval|"Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period.~BMS747158: dosages at rest and at stress were not to exceed a total of 14 mCi.~Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period."
458566|NCT00849056|B3|Baseline|Total|Total of all reporting groups
458567|NCT00849056|B2|Baseline|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458568|NCT00849056|B1|Baseline|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458569|NCT00849056|P2|Participant Flow|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458570|NCT00849056|P1|Participant Flow|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458571|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458572|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458573|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458574|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458575|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458576|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458577|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458578|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458579|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458580|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458581|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458582|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458583|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458584|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458585|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458586|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458587|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458588|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458589|NCT00849056|E2|Reported Event|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458590|NCT00849056|E1|Reported Event|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
458591|NCT00849017|B4|Baseline|Total|Total of all reporting groups
458592|NCT00849017|B3|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458593|NCT00849017|B2|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458594|NCT00849017|B1|Baseline|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458595|NCT00849017|P3|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458596|NCT00849017|P2|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458597|NCT00849017|P1|Participant Flow|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458599|NCT00849017|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458600|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458601|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458602|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458603|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458604|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458605|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458606|NCT00849017|O3|Outcome|Albiglutide 50 mg Weekly|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458607|NCT00849017|O2|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458608|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458609|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458610|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458611|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458612|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458613|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458614|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458615|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458616|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458617|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458618|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458619|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458620|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458621|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458622|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458623|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458624|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458625|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458627|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458628|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458629|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458630|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458631|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458632|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458633|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458634|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458635|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458636|NCT00849017|E3|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458637|NCT00849017|E2|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458638|NCT00849017|E1|Reported Event|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
458639|NCT00848965|B1|Baseline|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
458640|NCT00848965|P1|Participant Flow|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
458641|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458642|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458643|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458644|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458645|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458646|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458647|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458648|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458649|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458650|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458651|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458652|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458653|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458654|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458655|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458656|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458657|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458658|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458659|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458660|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458661|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458662|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458663|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458664|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458665|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458666|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458667|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458668|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458669|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458670|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458671|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458672|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458673|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458674|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458675|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458676|NCT00848965|E5|Reported Event|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458677|NCT00848965|E4|Reported Event|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458678|NCT00848965|E3|Reported Event|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458679|NCT00848965|E2|Reported Event|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
458680|NCT00848965|E1|Reported Event|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
458681|NCT00848926|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458682|NCT00848926|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
458683|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458684|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458685|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458686|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458687|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458688|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458689|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458690|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458691|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458692|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458693|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458694|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458695|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458696|NCT00848926|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
458697|NCT00848783|B4|Baseline|Total|Total of all reporting groups
458698|NCT00848783|B3|Baseline|Induction Treatment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
458699|NCT00848783|B2|Baseline|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
461480|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458700|NCT00848783|B1|Baseline|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
458701|NCT00848783|P3|Participant Flow|Induction Treartment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
458702|NCT00848783|P2|Participant Flow|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
458703|NCT00848783|P1|Participant Flow|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
458704|NCT00848783|O3|Outcome|Induction Treatment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
458705|NCT00848783|O2|Outcome|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
458706|NCT00848783|O1|Outcome|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
458707|NCT00848783|O2|Outcome|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
458708|NCT00848783|O1|Outcome|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
458709|NCT00848783|E2|Reported Event|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
458710|NCT00848783|E1|Reported Event|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
458711|NCT00848744|B1|Baseline|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
458712|NCT00848744|P1|Participant Flow|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
458713|NCT00848744|O2|Outcome|Formulation B|Participants used salicylic acid Formulation A on either the right or left side of the face.
458714|NCT00848744|O1|Outcome|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
458715|NCT00848744|O2|Outcome|Formulation B|Participants used salicylic acid Formulation A on either the right or left side of the face.
458716|NCT00848744|O1|Outcome|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
458717|NCT00848744|E1|Reported Event|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
458718|NCT00848549|B3|Baseline|Total|Total of all reporting groups
458719|NCT00848549|B2|Baseline|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458720|NCT00848549|B1|Baseline|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458721|NCT00848549|P2|Participant Flow|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458722|NCT00848549|P1|Participant Flow|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458723|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458724|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
459049|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
458725|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458726|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458727|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458728|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458729|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458730|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458731|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458732|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458733|NCT00848549|E4|Reported Event|Carbamazepine (Base Study 310, NCT00477295)|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
458734|NCT00848549|E3|Reported Event|Zonisamide (Base Study 310, NCT00477295)|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
458735|NCT00848549|E2|Reported Event|Carbamazepine (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458736|NCT00848549|E1|Reported Event|Zonisamide (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
458737|NCT00848536|B3|Baseline|Total|Total of all reporting groups
458738|NCT00848536|B2|Baseline|TRAVATAN|One drop once daily in the evening for 3 months
458739|NCT00848536|B1|Baseline|TRAVATAN APS|One drop once daily in the evening for 3 months
458740|NCT00848536|P2|Participant Flow|TRAVATAN|One drop once daily in the evening for 3 months
458741|NCT00848536|P1|Participant Flow|TRAVATAN APS|One drop once daily in the evening for 3 months
458742|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
458743|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
458744|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
458745|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
458746|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
458747|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
458748|NCT00848536|E2|Reported Event|TRAVATAN|One drop once daily in the evening for 3 months
458749|NCT00848536|E1|Reported Event|TRAVATAN APS|One drop once daily in the evening for 3 months
458750|NCT00848510|B5|Baseline|Total|Total of all reporting groups
458751|NCT00848510|B4|Baseline|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458752|NCT00848510|B3|Baseline|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
459050|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
458753|NCT00848510|B2|Baseline|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458754|NCT00848510|B1|Baseline|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458755|NCT00848510|P4|Participant Flow|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458756|NCT00848510|P3|Participant Flow|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458757|NCT00848510|P2|Participant Flow|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458758|NCT00848510|P1|Participant Flow|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) as assessed by the Response Evaluation Criteria in Solid Tumors version (RECIST) Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458759|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458760|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458761|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458762|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458763|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458764|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458765|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458766|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
459007|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
458767|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458768|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458769|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458770|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458771|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458772|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458773|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458774|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458775|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458776|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458777|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458778|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458779|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458780|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
459008|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459051|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
458781|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458782|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458783|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458784|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458785|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458786|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458787|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458788|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458789|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458790|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458791|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458792|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458793|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458794|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
459009|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459052|NCT00848211|E4|Reported Event|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
458795|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458796|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458797|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458798|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458799|NCT00848510|E4|Reported Event|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458800|NCT00848510|E3|Reported Event|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458801|NCT00848510|E2|Reported Event|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458802|NCT00848510|E1|Reported Event|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
458803|NCT00848497|B3|Baseline|Total|Total of all reporting groups
458804|NCT00848497|B2|Baseline|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
458805|NCT00848497|B1|Baseline|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
458806|NCT00848497|P2|Participant Flow|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
458807|NCT00848497|P1|Participant Flow|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
458808|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
458809|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
458810|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
458811|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
458812|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
458813|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
458814|NCT00848497|O2|Outcome|Placebo Testim + Viagra|"Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = 0 SHIM at 5 months = 0"
458815|NCT00848497|O1|Outcome|Testim + Viagra|"Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = N/A SHIM at 5 months = N/A"
458816|NCT00848497|E2|Reported Event|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
458817|NCT00848497|E1|Reported Event|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
458818|NCT00848484|B3|Baseline|Total|Total of all reporting groups
458819|NCT00848484|B2|Baseline|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
459010|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
458820|NCT00848484|B1|Baseline|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
458821|NCT00848484|P2|Participant Flow|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
458822|NCT00848484|P1|Participant Flow|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
458823|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458824|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458825|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458826|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458827|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458828|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458829|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458830|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458831|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458832|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458833|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458834|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458835|NCT00848484|E2|Reported Event|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458836|NCT00848484|E1|Reported Event|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
458837|NCT00848367|B3|Baseline|Total|Total of all reporting groups
458838|NCT00848367|B2|Baseline|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
458839|NCT00848367|B1|Baseline|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
459053|NCT00848211|E3|Reported Event|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461481|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458840|NCT00848367|P2|Participant Flow|High Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety (i.e. others that scored above the cut off). The type of therapy provided was called Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
458841|NCT00848367|P1|Participant Flow|Low Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety (i.e. others that scored below the cut off). The type of therapy administered to this group was Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
458842|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
458843|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
458844|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
458845|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
458846|NCT00848367|E2|Reported Event|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
458847|NCT00848367|E1|Reported Event|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
458848|NCT00848354|B3|Baseline|Total|Total of all reporting groups
458849|NCT00848354|B2|Baseline|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458850|NCT00848354|B1|Baseline|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458851|NCT00848354|P2|Participant Flow|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458852|NCT00848354|P1|Participant Flow|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection subcutaneously (s.c.) once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459011|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459012|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459104|NCT00848185|E3|Reported Event|Long Protocol - hCG Trigger|Long protocol and hCG trigger as control
458853|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458854|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458855|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458856|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458857|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458858|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458859|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458860|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458861|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458862|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459035|NCT00848211|B1|Baseline|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461482|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458863|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458864|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458865|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458866|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458867|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458868|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458869|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458870|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458871|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458872|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459036|NCT00848211|P4|Participant Flow|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461483|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458873|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458874|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458875|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458876|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458877|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458878|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458879|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458880|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458881|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458882|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459037|NCT00848211|P3|Participant Flow|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461484|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458883|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458884|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458885|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458886|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458887|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458888|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458889|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458890|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458891|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458892|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459038|NCT00848211|P2|Participant Flow|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461485|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458893|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458894|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458895|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458896|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458897|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458898|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458899|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458900|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458901|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458902|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459039|NCT00848211|P1|Participant Flow|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461486|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458903|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458904|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458905|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458906|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458907|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458908|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458909|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458910|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458911|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458912|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459040|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459205|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
458913|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458914|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458915|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458916|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458917|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458918|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458919|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458920|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458921|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458922|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459041|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461487|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458923|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458924|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458925|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458926|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458927|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458928|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458929|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458930|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458931|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458932|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459042|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461488|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458933|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458934|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458935|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458936|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458937|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458938|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458939|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458940|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458941|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458942|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459043|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461489|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458943|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458944|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458945|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458946|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458947|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458948|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458949|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458950|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458951|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458952|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459044|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459206|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
458953|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458954|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458955|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458956|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458957|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458958|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458959|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458960|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458961|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458962|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459045|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461490|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458963|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458964|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458965|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458966|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458967|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458968|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458969|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458970|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458971|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458972|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459046|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461491|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458973|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458974|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458975|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458976|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458977|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458978|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458979|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458980|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458981|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458982|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459047|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
461492|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
458983|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458984|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458985|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458986|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458987|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458988|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458989|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458990|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458991|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458992|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459048|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459207|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
458993|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458994|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458995|NCT00848354|E6|Reported Event|DMARD + Methotrexate Phase 2 Year 2|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458996|NCT00848354|E5|Reported Event|Etanercept + Methotrexate Phase 2 Year 2|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458997|NCT00848354|E4|Reported Event|DMARD + Methotrexate Phase 2 Year 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458998|NCT00848354|E3|Reported Event|Etanercept + Methotrexate Phase 2 Year 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
458999|NCT00848354|E2|Reported Event|DMARD + Methotrexate Phase 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459000|NCT00848354|E1|Reported Event|Etanercept + Methotrexate Phase 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
459001|NCT00848250|B3|Baseline|Total|Total of all reporting groups
459002|NCT00848250|B2|Baseline|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459003|NCT00848250|B1|Baseline|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459004|NCT00848250|P2|Participant Flow|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459005|NCT00848250|P1|Participant Flow|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459006|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459208|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459013|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459014|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459015|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459016|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459017|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459018|NCT00848250|O2|Outcome|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459019|NCT00848250|O1|Outcome|ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459020|NCT00848250|E2|Reported Event|No ACE Inhibitor|"Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery~No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery"
459021|NCT00848250|E1|Reported Event|ACE Inhibitor|"Patients already on an ACE inhibitor will continue it until the day of surgery~Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery"
459022|NCT00848237|B1|Baseline|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459023|NCT00848237|P1|Participant Flow|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459024|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459025|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459026|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459027|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459028|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459029|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459030|NCT00848237|E1|Reported Event|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
459031|NCT00848211|B5|Baseline|Total|Total of all reporting groups
459032|NCT00848211|B4|Baseline|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459033|NCT00848211|B3|Baseline|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459034|NCT00848211|B2|Baseline|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459054|NCT00848211|E2|Reported Event|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459055|NCT00848211|E1|Reported Event|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
459056|NCT00848198|B1|Baseline|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
459057|NCT00848198|P1|Participant Flow|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
459058|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
459059|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
459060|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
459061|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
459062|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
459063|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
459064|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
459065|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
459066|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
459067|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
459068|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
459069|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
459070|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
459071|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
459072|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
459073|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
459074|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
459075|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
459076|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
459077|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
459078|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
459079|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
459080|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
459081|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
459082|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
459083|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
459084|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
459085|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
459086|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
459087|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
459088|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
459089|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
459090|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
459091|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
459092|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
459093|NCT00848198|E1|Reported Event|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
459094|NCT00848185|B4|Baseline|Total|Total of all reporting groups
459095|NCT00848185|B3|Baseline|Long Protocol-hCG|Long Protocol and hCG to trigger oocyte maturation
459096|NCT00848185|B2|Baseline|Antagonist-aGnRH to Trigger|Protocol with antagonist and 0.2 mg triptorelin to trigger oocyte maturation
459097|NCT00848185|B1|Baseline|Antagonist-hCG to Trigger|Protocol with antagonist and hCG to trigger oocyte maturation
459098|NCT00848185|P3|Participant Flow|Long Protocol hCG|Long Protocol with hCG to trigger oocyte maturation
459099|NCT00848185|P2|Participant Flow|Antagonist Trigger With hCG|Protocol with antagonist and hCG to trigger oocyte maturation
459100|NCT00848185|P1|Participant Flow|Antagonist Trigger With aGnRH|Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
459101|NCT00848185|O3|Outcome|Long Protocol- hCG|Levels of VEGF in folicular fluid of patients with long protocol anf hCG for triggering
459102|NCT00848185|O2|Outcome|Antagonist-aGnRH Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol and aGnRH for triggering
459103|NCT00848185|O1|Outcome|Antagonist-hCG Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol anf hCG for triggering
459106|NCT00848185|E1|Reported Event|GnRH Antagonist - hCG Trigger|GnRH antagonist protocol and hCG trigger
459107|NCT00848172|B3|Baseline|Total|Total of all reporting groups
459108|NCT00848172|B2|Baseline|Sequence Placebo / OA|First day: placebo Second day: octanoic acid
459109|NCT00848172|B1|Baseline|Sequence OA / Placebo|First day: octanoic acid Second day: placebo
459110|NCT00848172|P2|Participant Flow|Sequence Placebo / OA|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received Placebo on the second day of Visit 2, and a single oral dose of 4 mg/kg OA on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
459111|NCT00848172|P1|Participant Flow|Sequence OA / Placebo|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received a single oral dose of 4 mg/kg OA on the second day of Visit 2, and matching Placebo on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
459112|NCT00848172|O1|Outcome|Octanoic Acid AUC|
459113|NCT00848172|O1|Outcome|Octanoic Acid Tmax|
459114|NCT00848172|O2|Outcome|Placebo|
459115|NCT00848172|O1|Outcome|Octanoic Acid|
459116|NCT00848172|O2|Outcome|Placebo|
459117|NCT00848172|O1|Outcome|Octanoic Acid|
459118|NCT00848172|E3|Reported Event|Non-drug Related|AE was considered to be non-drug related, if no temporal connection was present between AE occurrence and drug administration (e.g. if AE occurred during the study, but prior to drug-administration), or an AE was clearly related to a study procedure (e.g. PICC line) rather than the study drug.
459119|NCT00848172|E2|Reported Event|Placebo|
459120|NCT00848172|E1|Reported Event|Octanoic Acid|
459121|NCT00848120|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459122|NCT00848120|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 24 weeks.
459123|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459124|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459125|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459126|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459127|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459128|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459129|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459130|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459131|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459132|NCT00848120|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
459133|NCT00848107|B1|Baseline|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459134|NCT00848107|P1|Participant Flow|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459135|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459136|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459137|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459138|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459139|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459140|NCT00848107|E1|Reported Event|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
459141|NCT00848081|B3|Baseline|Total|Total of all reporting groups
459142|NCT00848081|B2|Baseline|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459143|NCT00848081|B1|Baseline|Placebo|Placebo by mouth once daily for 12 weeks
459144|NCT00848081|P2|Participant Flow|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459145|NCT00848081|P1|Participant Flow|Placebo|Placebo by mouth once daily for 12 weeks
459146|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459147|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
459148|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459149|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
459150|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459151|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
459152|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459153|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
459154|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459155|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
459156|NCT00848081|E2|Reported Event|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
459159|NCT00848042|B3|Baseline|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
459160|NCT00848042|B2|Baseline|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
459161|NCT00848042|B1|Baseline|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
459162|NCT00848042|P3|Participant Flow|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
459163|NCT00848042|P2|Participant Flow|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
459164|NCT00848042|P1|Participant Flow|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
459165|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
459166|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
459167|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
459168|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
459169|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
459170|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
459171|NCT00848042|E3|Reported Event|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
459172|NCT00848042|E2|Reported Event|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
459173|NCT00848042|E1|Reported Event|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
459174|NCT00848016|B1|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459175|NCT00848016|P1|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459176|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459177|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459178|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459179|NCT00848016|E1|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459180|NCT00847912|B3|Baseline|Total|Total of all reporting groups
459181|NCT00847912|B2|Baseline|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
459182|NCT00847912|B1|Baseline|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
459183|NCT00847912|P2|Participant Flow|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
459209|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459210|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459211|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459212|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459213|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459184|NCT00847912|P1|Participant Flow|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
459185|NCT00847912|O2|Outcome|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
459186|NCT00847912|O1|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
459187|NCT00847912|O2|Outcome|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
459188|NCT00847912|O1|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-fluorouracil (5-FU) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
459189|NCT00847912|E2|Reported Event|Arm 2: Placebo|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
459190|NCT00847912|E1|Reported Event|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
459191|NCT00847886|B3|Baseline|Total|Total of all reporting groups
459192|NCT00847886|B2|Baseline|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459193|NCT00847886|B1|Baseline|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459194|NCT00847886|P2|Participant Flow|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459195|NCT00847886|P1|Participant Flow|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459196|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459197|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459198|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459199|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459200|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459201|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459202|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459203|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459204|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
461493|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
459218|NCT00847886|E2|Reported Event|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
459219|NCT00847886|E1|Reported Event|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
459220|NCT00847808|B1|Baseline|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459221|NCT00847808|P1|Participant Flow|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459222|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459223|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459224|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459225|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459226|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459227|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459228|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459229|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459230|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459231|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459232|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459233|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459234|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459235|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459236|NCT00847808|E1|Reported Event|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
459237|NCT00847704|B1|Baseline|Test Group|"Device: Assisted movement and enhanced sensation~Assisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.~Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments."
459238|NCT00847704|P1|Participant Flow|Test Group|Device: Assisted movement and enhanced sensation
459239|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
459240|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
459241|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
459242|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
459243|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
459244|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
459245|NCT00847704|E1|Reported Event|Test Treatment Group|Device: Subjects receiving AMES treatments.
459246|NCT00847665|B3|Baseline|Total|Total of all reporting groups
459247|NCT00847665|B2|Baseline|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459248|NCT00847665|B1|Baseline|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459249|NCT00847665|P2|Participant Flow|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459250|NCT00847665|P1|Participant Flow|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459251|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459252|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459253|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459254|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459255|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459256|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459257|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459258|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459259|NCT00847665|E2|Reported Event|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459260|NCT00847665|E1|Reported Event|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
459261|NCT00847626|B12|Baseline|Total|Total of all reporting groups
459262|NCT00847626|B11|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459263|NCT00847626|B10|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459264|NCT00847626|B9|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459265|NCT00847626|B8|Baseline|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459266|NCT00847626|B7|Baseline|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459267|NCT00847626|B6|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459268|NCT00847626|B5|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459269|NCT00847626|B4|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459270|NCT00847626|B3|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459271|NCT00847626|B2|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459272|NCT00847626|B1|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459273|NCT00847626|P11|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459274|NCT00847626|P10|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459275|NCT00847626|P9|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459276|NCT00847626|P8|Participant Flow|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459277|NCT00847626|P7|Participant Flow|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459278|NCT00847626|P6|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459279|NCT00847626|P5|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459280|NCT00847626|P4|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459281|NCT00847626|P3|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459282|NCT00847626|P2|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459283|NCT00847626|P1|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459284|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459285|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459286|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459287|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459288|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459289|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459290|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459291|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459292|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459293|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459481|NCT00847613|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459294|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459295|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459296|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459297|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459298|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459299|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459300|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459301|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459302|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459303|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459304|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459305|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459306|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459307|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459308|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459309|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459310|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459311|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459312|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459313|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459314|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459315|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459316|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459317|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459318|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459319|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459320|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459321|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459322|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459323|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459324|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459325|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459326|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459327|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459328|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459329|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459330|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459331|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459561|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459332|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459333|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459334|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459335|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459336|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459337|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459338|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459339|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459340|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459341|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459342|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459343|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459344|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459345|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459346|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459347|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459348|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459349|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459350|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459351|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459352|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459353|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459354|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459355|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459356|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459357|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459358|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459359|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459360|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459361|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459362|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459363|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459364|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459365|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459366|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459367|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459368|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459369|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459977|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459370|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459371|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459372|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459373|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459374|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459375|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459376|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459377|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459378|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459379|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459380|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459381|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459382|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459383|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459384|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459385|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459386|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459387|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459388|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459389|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459390|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459391|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459392|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459393|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459394|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459395|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459396|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459397|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459398|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459399|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459400|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459401|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459402|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459403|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459404|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459405|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459406|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459407|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459978|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459408|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459409|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459410|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459411|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459412|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459413|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459414|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459415|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459416|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459417|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459418|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459419|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459420|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459421|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459422|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459423|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459424|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459425|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459426|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459427|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459428|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459429|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459430|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459431|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459432|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459433|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459434|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459435|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459436|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459437|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459438|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459439|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459440|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459441|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459442|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459443|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459444|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459445|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459562|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459446|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459447|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459448|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459449|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459450|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459451|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.~OR~Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
459452|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459453|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459454|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459455|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459456|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459457|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459458|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459459|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459460|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459461|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459462|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459463|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459464|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459465|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.~OR~Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
459466|NCT00847626|E11|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459467|NCT00847626|E10|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459468|NCT00847626|E9|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
459469|NCT00847626|E8|Reported Event|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459470|NCT00847626|E7|Reported Event|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459471|NCT00847626|E6|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459472|NCT00847626|E5|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459473|NCT00847626|E4|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459474|NCT00847626|E3|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459475|NCT00847626|E2|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
459476|NCT00847626|E1|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
459477|NCT00847613|B5|Baseline|Total|Total of all reporting groups
459478|NCT00847613|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459479|NCT00847613|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459480|NCT00847613|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459482|NCT00847613|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459483|NCT00847613|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459484|NCT00847613|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459485|NCT00847613|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459486|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459487|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459488|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459489|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459490|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459491|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459492|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459493|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459494|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459495|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459496|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459497|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459498|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459499|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459500|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459501|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459502|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459503|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459504|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459505|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459506|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459507|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459703|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
461494|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
459508|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459509|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459510|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459511|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459512|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459513|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459514|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459515|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459516|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459517|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459518|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459519|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459520|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459521|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459522|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459523|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459524|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459525|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459526|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459527|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459528|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459529|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459530|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459531|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459532|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459533|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459534|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459535|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459536|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459537|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459538|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459539|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459540|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459541|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459542|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459543|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459544|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459545|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459546|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459547|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459548|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459549|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459550|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459551|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459552|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459553|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459554|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459555|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459556|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459557|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459558|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459559|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459560|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459563|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459564|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459565|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459566|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459567|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459568|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459569|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459570|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459571|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459572|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459573|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459574|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459575|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459576|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459577|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459578|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459579|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459580|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459581|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459582|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459583|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459584|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459585|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459586|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459587|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459588|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459589|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459590|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459591|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459592|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459593|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459594|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459595|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459596|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459597|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459598|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459599|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459600|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459601|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459602|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459603|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459604|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459605|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459606|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459607|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459608|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459609|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459610|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459611|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459612|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459613|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459614|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459615|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459616|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459617|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459618|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459619|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459620|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459621|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459622|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459623|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459624|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459625|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459626|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459627|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459628|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459629|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459630|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459631|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459632|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459633|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459634|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459635|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459636|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459637|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459638|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459639|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459640|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459641|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459642|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459643|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459644|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459645|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459646|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459647|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459648|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459649|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459650|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459651|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459652|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459653|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459654|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459655|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459656|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459657|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459658|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459659|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459660|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459661|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459662|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459663|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459664|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459665|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459666|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459667|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459668|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459669|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459670|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459671|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459672|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459673|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459674|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459675|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459676|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459677|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459678|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459679|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459680|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459681|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459682|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459683|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459684|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459685|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459686|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459687|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459688|NCT00847613|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459689|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459690|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459691|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459692|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459693|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459694|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459695|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
459696|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
459697|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459698|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459699|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459700|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459701|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459702|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459704|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459705|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459706|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459707|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459708|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459709|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459710|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459711|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
459712|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
459713|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
459714|NCT00847613|E8|Reported Event|CP-690,550 10 mg (Post Month 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 6, received CP-690,550 10 mg tablet orally twice daily from Month 6 to 24.
459715|NCT00847613|E7|Reported Event|CP-690,550 5 mg (Post Month 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 6, received CP-690,550 5 mg tablet orally twice daily from Month 6 to 24.
459716|NCT00847613|E6|Reported Event|Placebo (Month 3 to 6)|Participants received placebo matched to CP-690,550 tablet orally twice daily from Month 3 to 6.
459717|NCT00847613|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 3, received CP-690,550 10 mg tablet orally twice daily from Month 3 to 6.
459718|NCT00847613|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 3, received CP-690,550 5 mg tablet orally twice daily from Month 3 to 6.
459719|NCT00847613|E3|Reported Event|Placebo (Up to Month 3)|Participants received placebo matched to CP-690,550 tablet orally twice daily up to Month 3.
459720|NCT00847613|E2|Reported Event|CP-690,550 10 mg (Up to Month 3)|Participants received CP-690,550 10 mg tablet orally twice daily up to Month 3.
459721|NCT00847613|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|Participants received CP-690,550 5 mg tablet orally twice daily up to Month 3.
459722|NCT00847587|B3|Baseline|Total|Total of all reporting groups
459723|NCT00847587|B2|Baseline|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
459724|NCT00847587|B1|Baseline|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
459725|NCT00847587|P2|Participant Flow|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
459726|NCT00847587|P1|Participant Flow|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
459727|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
459728|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
459729|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
459730|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
459731|NCT00847587|E2|Reported Event|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
459732|NCT00847587|E1|Reported Event|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
459733|NCT00847561|B3|Baseline|Total|Total of all reporting groups
459734|NCT00847561|B2|Baseline|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
459735|NCT00847561|B1|Baseline|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
459736|NCT00847561|P2|Participant Flow|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
459792|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
459793|NCT00847288|E2|Reported Event|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
459737|NCT00847561|P1|Participant Flow|Family-based CBT|"Family-based Cognitive Behavioral Therapy (CBT). Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
459738|NCT00847561|O2|Outcome|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
459739|NCT00847561|O1|Outcome|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
459740|NCT00847561|E2|Reported Event|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
459741|NCT00847561|E1|Reported Event|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
459742|NCT00847535|B1|Baseline|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
459743|NCT00847535|P3|Participant Flow|Part II: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
459744|NCT00847535|P2|Participant Flow|Part I: Periurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
459745|NCT00847535|P1|Participant Flow|Part I: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
459746|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
459747|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
459748|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
459749|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
459750|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
459751|NCT00847535|E1|Reported Event|Patients|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women
459752|NCT00847522|B1|Baseline|All Patients|"All participants enrolled.~Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps."
459753|NCT00847522|P1|Participant Flow|All Patients|"Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.~Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps."
459754|NCT00847522|O1|Outcome|All Patients|"Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.~Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps."
459755|NCT00847522|O1|Outcome|All Patients|"Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.~Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps."
459794|NCT00847288|E1|Reported Event|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
459756|NCT00847522|E1|Reported Event|Phase I/II Patients|Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
459757|NCT00847509|B1|Baseline|[F-18]FLT Scan|
459758|NCT00847509|P1|Participant Flow|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
459759|NCT00847509|O1|Outcome|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
459760|NCT00847509|E1|Reported Event|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
459761|NCT00847405|B3|Baseline|Total|Total of all reporting groups
459762|NCT00847405|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
459763|NCT00847405|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
459764|NCT00847405|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
459765|NCT00847405|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
459766|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
459767|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
459768|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
459769|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
459770|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
459771|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
459772|NCT00847301|B1|Baseline|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
459773|NCT00847301|P1|Participant Flow|Overall Study Design|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily
459774|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
459775|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
459776|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
459777|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
459778|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
459779|NCT00847301|E1|Reported Event|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
459780|NCT00847288|B3|Baseline|Total|Total of all reporting groups
459781|NCT00847288|B2|Baseline|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
459782|NCT00847288|B1|Baseline|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
459783|NCT00847288|P2|Participant Flow|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
459784|NCT00847288|P1|Participant Flow|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
459785|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
459786|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
459787|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
459788|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
459789|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
459790|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
459791|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
459795|NCT00847210|B3|Baseline|Total|Total of all reporting groups
459796|NCT00847210|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459797|NCT00847210|B1|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459798|NCT00847210|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459799|NCT00847210|P1|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459800|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459801|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459802|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459803|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459804|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459805|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459806|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459807|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459808|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459809|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459810|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459811|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459812|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459813|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459814|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459815|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459816|NCT00847210|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
459817|NCT00847210|E1|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
459818|NCT00847197|B3|Baseline|Total|Total of all reporting groups
459819|NCT00847197|B2|Baseline|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459820|NCT00847197|B1|Baseline|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459821|NCT00847197|P2|Participant Flow|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459822|NCT00847197|P1|Participant Flow|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459823|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459824|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459825|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459826|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459827|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459828|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459829|NCT00847197|E2|Reported Event|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459830|NCT00847197|E1|Reported Event|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
459831|NCT00847145|B9|Baseline|Total|Total of all reporting groups
459832|NCT00847145|B8|Baseline|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
459833|NCT00847145|B7|Baseline|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459834|NCT00847145|B6|Baseline|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
459835|NCT00847145|B5|Baseline|12B12M (3a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459836|NCT00847145|B4|Baseline|12M12B14B (2b)|Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
459859|NCT00847145|O3|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
459837|NCT00847145|B3|Baseline|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
459838|NCT00847145|B2|Baseline|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459839|NCT00847145|B1|Baseline|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459840|NCT00847145|P8|Participant Flow|12B13M_C (4b)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
459841|NCT00847145|P7|Participant Flow|12B12M_C (4a)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459842|NCT00847145|P6|Participant Flow|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
459843|NCT00847145|P5|Participant Flow|12B12M (3a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459844|NCT00847145|P4|Participant Flow|12M12B14B (2b)|Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
459845|NCT00847145|P3|Participant Flow|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
459846|NCT00847145|P2|Participant Flow|12B13M (1b)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459847|NCT00847145|P1|Participant Flow|12B12M (1a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459848|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
459849|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
459850|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
459851|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
459852|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
459853|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
459854|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
459855|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
459856|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
459857|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
459858|NCT00847145|O4|Outcome|12B13M|Combination of Groups 12B13M (1b) and 12B13M (3b).
459860|NCT00847145|O2|Outcome|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
459861|NCT00847145|O1|Outcome|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459862|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459863|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459864|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
459865|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
459866|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459867|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459868|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
459869|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
459870|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
459871|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
459872|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine was given concomitantly at 12 months of age in the present study
459873|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
459874|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
459875|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
459876|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459877|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
459878|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
459879|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
459880|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459881|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
459882|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459883|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459884|NCT00847145|O2|Outcome|12M13B15B (2a)|Previously in the parent study subjects had received only routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age in the present study.
459885|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine.
459886|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
459887|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
459888|NCT00847145|E6|Reported Event|12B13M_C (4b)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.~4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
459889|NCT00847145|E5|Reported Event|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
459890|NCT00847145|E4|Reported Event|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
459891|NCT00847145|E3|Reported Event|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
459892|NCT00847145|E2|Reported Event|12B13M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.~This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes."
459893|NCT00847145|E1|Reported Event|12B12M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes."
459894|NCT00847132|B3|Baseline|Total|Total of all reporting groups
459895|NCT00847132|B2|Baseline|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
459896|NCT00847132|B1|Baseline|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
459897|NCT00847132|P2|Participant Flow|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
459898|NCT00847132|P1|Participant Flow|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
459899|NCT00847132|O2|Outcome|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
459900|NCT00847132|O1|Outcome|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
459901|NCT00847132|O2|Outcome|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
459902|NCT00847132|O1|Outcome|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
459903|NCT00847132|E2|Reported Event|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
461495|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
459904|NCT00847132|E1|Reported Event|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
459905|NCT00847015|B1|Baseline|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
459906|NCT00847015|P1|Participant Flow|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
459907|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
459908|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
459909|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
459910|NCT00847015|E1|Reported Event|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
459911|NCT00847002|B3|Baseline|Total|Total of all reporting groups
459912|NCT00847002|B2|Baseline|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
459913|NCT00847002|B1|Baseline|Standard of Care Wound Treatment|Standard Wound Care using compression
459914|NCT00847002|P2|Participant Flow|Flexitouch System|Flexitouch system with Standard Wound Care using compression
459915|NCT00847002|P1|Participant Flow|Standard of Care|Standard Wound Care using compression
459916|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
459917|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
459918|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
459919|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
459920|NCT00847002|E2|Reported Event|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
459921|NCT00847002|E1|Reported Event|Standard of Care Wound Treatment|Standard Wound Care using compression
459922|NCT00846885|B3|Baseline|Total|Total of all reporting groups
459923|NCT00846885|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
459924|NCT00846885|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
459925|NCT00846885|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
459926|NCT00846885|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
459927|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
459928|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
459929|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
459930|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
459931|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
459932|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
459933|NCT00846846|B1|Baseline|Endeavor® Zotarolimus Eluting Coronary Stent System|Endeavor® Zotarolimus Eluting Coronary Stent Implantation in a patient population requiring stent implantation.
459934|NCT00846846|P1|Participant Flow|Endeavor® Zotarolimus Eluting Coronary Stent System|"Endeavor® Zotarolimus Eluting Coronary Stent System >~> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation"
459935|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
459936|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
459937|NCT00846846|E1|Reported Event|Endeavor|Medtronic Endeavor
459938|NCT00846807|B1|Baseline|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459939|NCT00846807|P1|Participant Flow|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459940|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459941|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459942|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459943|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459944|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459945|NCT00846807|E1|Reported Event|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
459946|NCT00846768|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, active-controlled, 4 way crossover trial. 47 patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments. The duration of each treatment period was 3 weeks with no washout period between treatments.
459947|NCT00846768|P4|Participant Flow|Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg bid in the second period, Olodaterol 2 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
459948|NCT00846768|P3|Participant Flow|Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid|Patients were administered Olodaterol 5 mcg bid in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 2 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
459949|NCT00846768|P2|Participant Flow|Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg bid in the second period, Olodaterol 5 mcg bid in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
459950|NCT00846768|P1|Participant Flow|Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid|Patients were administered Olodaterol 2 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and Olodaterol 5 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
459951|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459952|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459953|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459954|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459955|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459956|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459957|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459958|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459959|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459960|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459961|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459962|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459963|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459964|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459965|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459966|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459967|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459968|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459969|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459970|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459971|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459972|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459973|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459974|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459979|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459980|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459981|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459982|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459983|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459984|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459985|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459986|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459987|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459988|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459989|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459990|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459991|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459992|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459993|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459994|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459995|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
459996|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
459997|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
459998|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
459999|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
460000|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
460001|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
460002|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
460003|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
460004|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
460005|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
460006|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
460007|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
460008|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
460009|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
460010|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
460011|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
460012|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
460013|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
460014|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
460015|NCT00846768|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
460016|NCT00846768|E3|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
460017|NCT00846768|E2|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
460018|NCT00846768|E1|Reported Event|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
460019|NCT00846651|B3|Baseline|Total|Total of all reporting groups
460020|NCT00846651|B2|Baseline|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460021|NCT00846651|B1|Baseline|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460022|NCT00846651|P2|Participant Flow|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460023|NCT00846651|P1|Participant Flow|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460024|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460025|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460026|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460027|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460028|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|"crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.~Crystalloid administration: The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.~phenylephrine infusion: A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."
460029|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|"colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.~Colloid administration: The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.~phenylephrine infusion: A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision."
460030|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460031|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460032|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460033|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460034|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460035|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460036|NCT00846651|E2|Reported Event|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460037|NCT00846651|E1|Reported Event|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
460038|NCT00846586|B3|Baseline|Total|Total of all reporting groups
460039|NCT00846586|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460040|NCT00846586|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460041|NCT00846586|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460042|NCT00846586|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460043|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460044|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460241|NCT00845858|P2|Participant Flow|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460045|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460046|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460047|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460048|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460049|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460050|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460051|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460052|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460053|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460054|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460055|NCT00846586|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460056|NCT00846586|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
460057|NCT00846573|B4|Baseline|Total|Total of all reporting groups
460058|NCT00846573|B3|Baseline|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460059|NCT00846573|B2|Baseline|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
460060|NCT00846573|B1|Baseline|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460061|NCT00846573|P4|Participant Flow|Healthy|"This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460062|NCT00846573|P3|Participant Flow|Cystic Fibrosis|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460063|NCT00846573|P2|Participant Flow|Asthma|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
460064|NCT00846573|P1|Participant Flow|COPD|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460065|NCT00846573|O3|Outcome|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460066|NCT00846573|O2|Outcome|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
460067|NCT00846573|O1|Outcome|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460068|NCT00846573|E3|Reported Event|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460069|NCT00846573|E2|Reported Event|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
460070|NCT00846573|E1|Reported Event|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
460071|NCT00846547|B1|Baseline|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
460072|NCT00846547|P1|Participant Flow|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
460073|NCT00846547|O1|Outcome|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
460074|NCT00846547|E1|Reported Event|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
460075|NCT00846521|B1|Baseline|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
460095|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460242|NCT00845858|P1|Participant Flow|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460076|NCT00846521|P1|Participant Flow|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
460077|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
460078|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
460079|NCT00846521|E1|Reported Event|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
460080|NCT00846495|B3|Baseline|Total|Total of all reporting groups
460081|NCT00846495|B2|Baseline|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460082|NCT00846495|B1|Baseline|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460083|NCT00846495|P2|Participant Flow|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460084|NCT00846495|P1|Participant Flow|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460085|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460086|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460087|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460088|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460089|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460090|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460091|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460092|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460093|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460094|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460233|NCT00845897|E3|Reported Event|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
460234|NCT00845897|E2|Reported Event|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
460096|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460097|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460098|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460099|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460100|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460101|NCT00846495|E2|Reported Event|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
460102|NCT00846495|E1|Reported Event|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
460103|NCT00846391|B4|Baseline|Total|Total of all reporting groups
460104|NCT00846391|B3|Baseline|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
460105|NCT00846391|B2|Baseline|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
460106|NCT00846391|B1|Baseline|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
460107|NCT00846391|P3|Participant Flow|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
460108|NCT00846391|P2|Participant Flow|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
460109|NCT00846391|P1|Participant Flow|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
460110|NCT00846391|O3|Outcome|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
460111|NCT00846391|O2|Outcome|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
460112|NCT00846391|O1|Outcome|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
460113|NCT00846391|E3|Reported Event|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
460114|NCT00846391|E2|Reported Event|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
460115|NCT00846391|E1|Reported Event|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
460116|NCT00846365|B4|Baseline|Total|Total of all reporting groups
460117|NCT00846365|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460118|NCT00846365|B2|Baseline|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460119|NCT00846365|B1|Baseline|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460120|NCT00846365|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460121|NCT00846365|P2|Participant Flow|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460122|NCT00846365|P1|Participant Flow|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460123|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460124|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460125|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460126|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460127|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460128|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460129|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460130|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460131|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460132|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460133|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460134|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460135|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460136|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460243|NCT00845858|O3|Outcome|Female-Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
460137|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460138|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460139|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460140|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460141|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460142|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460143|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460144|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460145|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460146|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460147|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460148|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460149|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460150|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460151|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460152|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460235|NCT00845897|E1|Reported Event|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
460153|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460154|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460155|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460156|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460157|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460158|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460159|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460160|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460161|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460162|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460163|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460164|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460165|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460166|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460167|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460168|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460236|NCT00845858|B4|Baseline|Total|Total of all reporting groups
460169|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460170|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460171|NCT00846365|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460172|NCT00846365|E2|Reported Event|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460173|NCT00846365|E1|Reported Event|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
460174|NCT00846287|B3|Baseline|Total|Total of all reporting groups
460175|NCT00846287|B2|Baseline|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460176|NCT00846287|B1|Baseline|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460177|NCT00846287|P2|Participant Flow|Active Comparator: Drug Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460178|NCT00846287|P1|Participant Flow|Active Comparator: Saline|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460179|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460180|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
460237|NCT00845858|B3|Baseline|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
460238|NCT00845858|B2|Baseline|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460239|NCT00845858|B1|Baseline|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460240|NCT00845858|P3|Participant Flow|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
460181|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460182|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
460183|NCT00846287|E2|Reported Event|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460184|NCT00846287|E1|Reported Event|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
460185|NCT00846066|B3|Baseline|Total|Total of all reporting groups
460186|NCT00846066|B2|Baseline|WBT+HOT|Web Based Training plus Hands on Training
460187|NCT00846066|B1|Baseline|WBT Only|Control Group Web Based Training only
460188|NCT00846066|P2|Participant Flow|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
460189|NCT00846066|P1|Participant Flow|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
460190|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
460191|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
460192|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
460193|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
460194|NCT00846066|O2|Outcome|WBT + HOT|Web Based Training plus Hands on Training
460195|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
460196|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
460197|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
460198|NCT00846066|E2|Reported Event|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
460199|NCT00846066|E1|Reported Event|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
460200|NCT00846027|B1|Baseline|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
460201|NCT00846027|P1|Participant Flow|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
460202|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
460203|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
460204|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
460205|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
460206|NCT00846027|E1|Reported Event|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
460207|NCT00845975|B3|Baseline|Total|Total of all reporting groups
460208|NCT00845975|B2|Baseline|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
460209|NCT00845975|B1|Baseline|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
460210|NCT00845975|P2|Participant Flow|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
460211|NCT00845975|P1|Participant Flow|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
460212|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
460213|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
460214|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
460215|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
460216|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
460217|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
460218|NCT00845975|E2|Reported Event|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
460219|NCT00845975|E1|Reported Event|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
460220|NCT00845897|B4|Baseline|Total|Total of all reporting groups
460221|NCT00845897|B3|Baseline|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
460222|NCT00845897|B2|Baseline|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
460223|NCT00845897|B1|Baseline|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
460224|NCT00845897|P3|Participant Flow|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
460225|NCT00845897|P2|Participant Flow|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
460226|NCT00845897|P1|Participant Flow|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
460227|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
460228|NCT00845897|O2|Outcome|Placebo|Saline
460229|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
460230|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
460231|NCT00845897|O2|Outcome|Placebo|Saline
460232|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
460244|NCT00845858|O2|Outcome|Female-Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460245|NCT00845858|O1|Outcome|Female-Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460246|NCT00845858|O3|Outcome|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
460247|NCT00845858|O2|Outcome|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460248|NCT00845858|O1|Outcome|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460249|NCT00845858|E3|Reported Event|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
460250|NCT00845858|E2|Reported Event|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460251|NCT00845858|E1|Reported Event|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
460252|NCT00845845|B3|Baseline|Total|Total of all reporting groups
460253|NCT00845845|B2|Baseline|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
460254|NCT00845845|B1|Baseline|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
460255|NCT00845845|P2|Participant Flow|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
460256|NCT00845845|P1|Participant Flow|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
460257|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
460258|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
460259|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
460260|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
460261|NCT00845845|E2|Reported Event|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
460262|NCT00845845|E1|Reported Event|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
460263|NCT00845832|B4|Baseline|Total|Total of all reporting groups
460264|NCT00845832|B3|Baseline|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460265|NCT00845832|B2|Baseline|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460266|NCT00845832|B1|Baseline|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460267|NCT00845832|P3|Participant Flow|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460268|NCT00845832|P2|Participant Flow|Rituximab (0.5 Grams [g]) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460269|NCT00845832|P1|Participant Flow|Placebo + Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received placebo intravenously (iv) on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460270|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460271|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460272|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460273|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460341|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
461496|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
460274|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460275|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460276|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460277|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460278|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460279|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460280|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460281|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460282|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460283|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460284|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460285|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460286|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460287|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460288|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460289|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460290|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460291|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460292|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460293|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460294|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460295|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460296|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460297|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460298|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460299|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460300|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460301|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460302|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460303|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460304|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460305|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460306|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460307|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460308|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460309|NCT00845832|E3|Reported Event|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460310|NCT00845832|E2|Reported Event|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460311|NCT00845832|E1|Reported Event|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
460312|NCT00845728|B3|Baseline|Total|Total of all reporting groups
460313|NCT00845728|B2|Baseline|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
460314|NCT00845728|B1|Baseline|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
460315|NCT00845728|P2|Participant Flow|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
460316|NCT00845728|P1|Participant Flow|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
460317|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
460318|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
460319|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
460320|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
460321|NCT00845728|E2|Reported Event|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
460322|NCT00845728|E1|Reported Event|IndIndacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
460323|NCT00845702|B1|Baseline|TOF and Dotarem Enhanced MRA|Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).
460324|NCT00845702|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).
460325|NCT00845702|O2|Outcome|Time Of Flight MRA|Each subject will undergo a TOF MRA
460326|NCT00845702|O1|Outcome|Dotarem MRA|Each subject will receive one injection of Dotarem 0.2 ml/kg.
460327|NCT00845702|E2|Reported Event|Time Of Flight MRA|Subjects undergo a TOF MRA
460328|NCT00845702|E1|Reported Event|Dotarem Magnetic Resonance Angiography|Each subject will receive one injection of Dotarem 0.2 ml/kg.
460329|NCT00845676|B1|Baseline|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
460330|NCT00845676|P1|Participant Flow|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
460331|NCT00845676|O1|Outcome|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
460332|NCT00845676|E1|Reported Event|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
460333|NCT00845663|B3|Baseline|Total|Total of all reporting groups
460334|NCT00845663|B2|Baseline|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460335|NCT00845663|B1|Baseline|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460336|NCT00845663|P2|Participant Flow|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460337|NCT00845663|P1|Participant Flow|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460338|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460339|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460340|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460443|NCT00845182|B2|Baseline|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
460342|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460343|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460344|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460345|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460346|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460347|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460348|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460349|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460350|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460351|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460352|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460353|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460354|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460355|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460356|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460357|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460358|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460359|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460360|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460361|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460362|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460363|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460364|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460365|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460366|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460367|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460368|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460369|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460370|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460371|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460372|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
461497|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
460373|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460374|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460375|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460376|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460377|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460378|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460379|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460380|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460381|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460382|NCT00845663|E2|Reported Event|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460383|NCT00845663|E1|Reported Event|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
460384|NCT00845507|B3|Baseline|Total|Total of all reporting groups
460385|NCT00845507|B2|Baseline|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460386|NCT00845507|B1|Baseline|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460387|NCT00845507|P2|Participant Flow|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460388|NCT00845507|P1|Participant Flow|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460389|NCT00845507|O2|Outcome|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460390|NCT00845507|O1|Outcome|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460391|NCT00845507|O2|Outcome|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460392|NCT00845507|O1|Outcome|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460393|NCT00845507|E2|Reported Event|Placebo Group|"Placebo: Sterile solution in equivalent doses as Exenatide~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460394|NCT00845507|E1|Reported Event|Exenatide Group|"Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.~Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily."
460395|NCT00845481|B1|Baseline|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
460396|NCT00845481|P1|Participant Flow|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
460397|NCT00845481|O1|Outcome|Patients Treated With Diprosalic Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Diprosalic ointment
460398|NCT00845481|O1|Outcome|Patients Treated With Dermovat Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Dermovat ointment
460399|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment Vehicle|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® Ointment vehicle
460400|NCT00845481|O1|Outcome|Patients Treated With Elocon Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Elocon ointment
460401|NCT00845481|O1|Outcome|Patients Treated With Betnovat® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Betnovat® ointment
460402|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
460403|NCT00845481|E1|Reported Event|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
460404|NCT00845429|B4|Baseline|Total|Total of all reporting groups
460405|NCT00845429|B3|Baseline|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
460406|NCT00845429|B2|Baseline|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
460407|NCT00845429|B1|Baseline|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
460408|NCT00845429|P3|Participant Flow|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
460409|NCT00845429|P2|Participant Flow|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
460410|NCT00845429|P1|Participant Flow|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
460411|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
460412|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
460413|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
460414|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
460415|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
460416|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
460417|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
460418|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
460419|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
460420|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
460421|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
460422|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
460423|NCT00845429|E3|Reported Event|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
460424|NCT00845429|E2|Reported Event|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
460425|NCT00845429|E1|Reported Event|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
460426|NCT00845195|B3|Baseline|Total|Total of all reporting groups
460427|NCT00845195|B2|Baseline|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
460428|NCT00845195|B1|Baseline|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
460429|NCT00845195|P2|Participant Flow|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
460430|NCT00845195|P1|Participant Flow|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
460431|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
460432|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
460433|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
460434|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
460435|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
460436|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
460437|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
460438|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
460439|NCT00845195|E2|Reported Event|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
460440|NCT00845195|E1|Reported Event|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
460441|NCT00845182|B4|Baseline|Total|Total of all reporting groups
460442|NCT00845182|B3|Baseline|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
460444|NCT00845182|B1|Baseline|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
460445|NCT00845182|P3|Participant Flow|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
460446|NCT00845182|P2|Participant Flow|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
460447|NCT00845182|P1|Participant Flow|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
460448|NCT00845182|O1|Outcome|Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatid|"Effect pioglitazone, exenatide, and pioglitazone plus exenatide on~Insulin sensitivity~Inflammatory cytokines~glucagon and free fatty acids~plasma lipids measured over a 6 month period"
460449|NCT00845182|O3|Outcome|Drug Pioglitazone and Drug Exentatide|"Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide~Pioglitazone and Exenatide: Pioglitazone 30mg daily for 1 month and then 45mg daily for 5 months and Exenatide 5mcg twice daily for one month then 10mcg twice daily for 5 months"
460450|NCT00845182|O2|Outcome|Exenatide|"Exenatide: 15 subjects will be randomized to receive Exenatide~Exenatide: Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months"
460451|NCT00845182|O1|Outcome|Pioglitazone|"Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm~Pioglitazone: Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months"
460452|NCT00845182|O3|Outcome|PIOGLITAZONE and EXNATIDE|Combinatiton of PIoglitazone and Exenatide led to weight gain of 2.7 kg
460453|NCT00845182|O2|Outcome|EXENATIDE|PIO therapy led to a weigh loss of 2.4 kg
460454|NCT00845182|O1|Outcome|PIOGLITAZONE|PIO therapy led to a weigh gain of 5.5 kg
460455|NCT00845182|E3|Reported Event|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
460456|NCT00845182|E2|Reported Event|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
460457|NCT00845182|E1|Reported Event|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
460458|NCT00845130|B3|Baseline|Total|Total of all reporting groups
460459|NCT00845130|B2|Baseline|Health Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460460|NCT00845130|B1|Baseline|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460461|NCT00845130|P2|Participant Flow|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460462|NCT00845130|P1|Participant Flow|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460463|NCT00845130|O2|Outcome|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460464|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460465|NCT00845130|O2|Outcome|Healthy Subjects|Vitamin C levels in the living brain.
460466|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Vitamin C level in the living brain
460467|NCT00845130|E2|Reported Event|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460468|NCT00845130|E1|Reported Event|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
460469|NCT00845065|B3|Baseline|Total|Total of all reporting groups
460470|NCT00845065|B2|Baseline|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460471|NCT00845065|B1|Baseline|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460472|NCT00845065|P2|Participant Flow|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460473|NCT00845065|P1|Participant Flow|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460474|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460475|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460476|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460477|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460478|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460530|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460479|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460480|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460481|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460482|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460483|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460484|NCT00845065|E2|Reported Event|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
460485|NCT00845065|E1|Reported Event|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
460486|NCT00845000|B7|Baseline|Total|Total of all reporting groups
460487|NCT00845000|B6|Baseline|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460488|NCT00845000|B5|Baseline|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460489|NCT00845000|B4|Baseline|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460490|NCT00845000|B3|Baseline|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460491|NCT00845000|B2|Baseline|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460492|NCT00845000|B1|Baseline|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460493|NCT00845000|P6|Participant Flow|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460494|NCT00845000|P5|Participant Flow|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460588|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460495|NCT00845000|P4|Participant Flow|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460496|NCT00845000|P3|Participant Flow|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460497|NCT00845000|P2|Participant Flow|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460498|NCT00845000|P1|Participant Flow|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
460499|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
460500|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
460501|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
460502|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
460503|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
460504|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
460505|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
460506|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
460507|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
460508|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
460509|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
460510|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
460511|NCT00845000|E3|Reported Event|Placebo|Participants who received single oral dose of placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
460512|NCT00845000|E2|Reported Event|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
460513|NCT00845000|E1|Reported Event|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
460514|NCT00844896|B3|Baseline|Total|Total of all reporting groups
460515|NCT00844896|B2|Baseline|DEF + COPE|28 subjects in this arm of the study.
460516|NCT00844896|B1|Baseline|DEF-only|29 subjects in this arm of the study.
460517|NCT00844896|P2|Participant Flow|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460518|NCT00844896|P1|Participant Flow|DEF-only|Distress Emotional Support and Family Assessment Treatment
460519|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460520|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460521|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460522|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460523|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460524|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460525|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment.
460526|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460527|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460528|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460529|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460531|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460532|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460533|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460534|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460535|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
460536|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
460537|NCT00844896|E2|Reported Event|DEF + COPE|28 subjects in this arm of the study.
460538|NCT00844896|E1|Reported Event|DEF-only|29 subjects in this arm of the study.
460539|NCT00844883|B1|Baseline|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460540|NCT00844883|P1|Participant Flow|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460541|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460542|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460543|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460544|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460545|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460546|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460547|NCT00844883|O1|Outcome|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460548|NCT00844883|E1|Reported Event|Sorafenib and Drug Eluting Beads|"single arm~sorafenib: sorafenib: given 400 mg twice per day for as long as it is beneficial~LC Bead-TACE: LC Beads loaded with doxorubicin~Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period"
460549|NCT00844857|B3|Baseline|Total|Total of all reporting groups
460550|NCT00844857|B2|Baseline|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460551|NCT00844857|B1|Baseline|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460552|NCT00844857|P2|Participant Flow|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460553|NCT00844857|P1|Participant Flow|Olanzapine/Fluoxetine Combination|Olanzapine/fluoxetine Combination (OFC) 3 milligrams (mg) olanzapine and 25 mg fluoxetine (OFC 3/25) administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460554|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460555|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460556|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460557|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460558|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460559|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460560|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460636|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460561|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
460562|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460563|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460564|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460565|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460566|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460567|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
460568|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460569|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
460570|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460571|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460572|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460573|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460574|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460575|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460576|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460577|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460578|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460579|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460580|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460581|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460582|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460583|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
460584|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460585|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460586|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460587|NCT00844857|O1|Outcome|Olanzapine Plus Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460589|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460590|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460591|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460592|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally, once daily for 8 weeks.
460593|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460594|NCT00844857|E2|Reported Event|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
460595|NCT00844857|E1|Reported Event|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
460596|NCT00844844|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460597|NCT00844844|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460598|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460599|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460600|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460601|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460602|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460603|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460604|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460605|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460637|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460638|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460606|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460607|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460608|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460609|NCT00844844|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460610|NCT00844831|B1|Baseline|Lubiprostone Open Label|
460611|NCT00844831|P1|Participant Flow|Lubiprostone Open Label|
460612|NCT00844831|O2|Outcome|After Open Label Treatment|Subjects receive lubiprostone and bacteria is measured after Lubiprostone: 24 mcg bid for 28 days
460613|NCT00844831|O1|Outcome|Before Open Label Lubiprostone|Bacteria is measured before Lubiprostone: 24 mcg bid for 28 days
460614|NCT00844831|O1|Outcome|Treatment With Lubiprostone|Lubiprostone: 24 mcg bid for 28 days
460615|NCT00844831|O2|Outcome|After Open Label Treatment|After 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
460616|NCT00844831|O1|Outcome|Before Open Label Lubiprostone|Before 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily.
460617|NCT00844831|E1|Reported Event|Lubiprostone Open Label|4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
460618|NCT00844805|B3|Baseline|Total|Total of all reporting groups
460619|NCT00844805|B2|Baseline|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460620|NCT00844805|B1|Baseline|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
460621|NCT00844805|P4|Participant Flow|No Treatment|For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460622|NCT00844805|P3|Participant Flow|Naproxen|For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460623|NCT00844805|P2|Participant Flow|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460624|NCT00844805|P1|Participant Flow|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
460625|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460626|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
460627|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460628|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
460629|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460630|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460631|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460632|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460633|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460634|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460635|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460977|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
462616|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
460639|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460640|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
460641|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460642|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
460643|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460644|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
460645|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460646|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460647|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460648|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460649|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460650|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
460651|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460652|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
460653|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460654|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
460655|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460656|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460657|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460658|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
460659|NCT00844805|E4|Reported Event|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
460660|NCT00844805|E3|Reported Event|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
460661|NCT00844805|E2|Reported Event|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
460662|NCT00844805|E1|Reported Event|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
460663|NCT00844753|B5|Baseline|Total|Total of all reporting groups
460664|NCT00844753|B4|Baseline|Placebo Without Parent Management Training|Sugar pill administered twice daily.
460665|NCT00844753|B3|Baseline|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460666|NCT00844753|B2|Baseline|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
461498|NCT00843115|E1|Reported Event|Donepezil|As per physician prescription
460667|NCT00844753|B1|Baseline|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460668|NCT00844753|P4|Participant Flow|Placebo Without Parent Management Training|Sugar pill administered twice daily.
460669|NCT00844753|P3|Participant Flow|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460670|NCT00844753|P2|Participant Flow|Atomoxetine (ATX) Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
460671|NCT00844753|P1|Participant Flow|Atomoxetine (ATX) + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to adverse events. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training (PT)-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460672|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
460673|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460674|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
460675|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460676|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
460677|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460678|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
460705|NCT00844649|E2|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460706|NCT00844649|E1|Reported Event|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460707|NCT00844597|B7|Baseline|Total|Total of all reporting groups
460679|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
460680|NCT00844753|E2|Reported Event|Placebo|Data includes the placebo alone arm and the placebo+parent therapy arm
460681|NCT00844753|E1|Reported Event|Atomoxetine|Data includes both the ATX alone arm and the ATX+ parent therapy arm
460682|NCT00844714|B1|Baseline|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
460683|NCT00844714|P1|Participant Flow|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
460684|NCT00844714|O1|Outcome|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
460685|NCT00844714|E1|Reported Event|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
460686|NCT00844649|B3|Baseline|Total|Total of all reporting groups
460687|NCT00844649|B2|Baseline|Gemcitabine|"Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).~Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)."
460688|NCT00844649|B1|Baseline|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|"ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.~Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest"
460689|NCT00844649|P2|Participant Flow|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460690|NCT00844649|P1|Participant Flow|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460691|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460692|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460693|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460694|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460695|NCT00844649|O2|Outcome|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460696|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460697|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460698|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460699|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460700|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460701|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460702|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460703|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
460704|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
460708|NCT00844597|B6|Baseline|Cohort 6 - 20.0mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460709|NCT00844597|B5|Baseline|Cohort 5 - 10.0mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460710|NCT00844597|B4|Baseline|Cohort 4 - 4.0mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460711|NCT00844597|B3|Baseline|Cohort 3 - 2.0mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460712|NCT00844597|B2|Baseline|Cohort 2 - 1.0mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460713|NCT00844597|B1|Baseline|Cohort 1 - 0.5mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460714|NCT00844597|P6|Participant Flow|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460715|NCT00844597|P5|Participant Flow|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460716|NCT00844597|P4|Participant Flow|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460717|NCT00844597|P3|Participant Flow|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460718|NCT00844597|P2|Participant Flow|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460719|NCT00844597|P1|Participant Flow|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
460720|NCT00844597|O6|Outcome|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460721|NCT00844597|O5|Outcome|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460722|NCT00844597|O4|Outcome|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460723|NCT00844597|O3|Outcome|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460724|NCT00844597|O2|Outcome|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460725|NCT00844597|O1|Outcome|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460726|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period~AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
460727|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period~AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
460728|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
460729|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
460730|NCT00844597|E6|Reported Event|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460731|NCT00844597|E5|Reported Event|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460732|NCT00844597|E4|Reported Event|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460733|NCT00844597|E3|Reported Event|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460734|NCT00844597|E2|Reported Event|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460735|NCT00844597|E1|Reported Event|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
460736|NCT00844558|B3|Baseline|Total|Total of all reporting groups
460737|NCT00844558|B2|Baseline|Control|The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy.
460738|NCT00844558|B1|Baseline|Gait|The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback.
460739|NCT00844558|P2|Participant Flow|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
460740|NCT00844558|P1|Participant Flow|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
460741|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
460742|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
460743|NCT00844558|O2|Outcome|Control|"Gait Training Control Group Participants~Control: There is no intervention associated with this arm of the study"
460744|NCT00844558|O1|Outcome|Gait Training|"Gait Training Intervention Group Participants~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
460745|NCT00844558|O2|Outcome|Control|No adverse events
460746|NCT00844558|O1|Outcome|Gait|No adverse events
460747|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
460748|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
460749|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
460750|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
460751|NCT00844558|O2|Outcome|Control Group|No adverse events
460752|NCT00844558|O1|Outcome|Gait|No adverse events
460753|NCT00844558|E2|Reported Event|Control|Usual care for symptomatic knee OA through their usual healthcare providers and were not asked to make changes in their lifestyle. Usual care may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery and/or physical therapy.
460754|NCT00844558|E1|Reported Event|Gait|Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
460755|NCT00844545|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460756|NCT00844545|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460757|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460758|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460759|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460760|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460761|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460780|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460762|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460763|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460764|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460765|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460766|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460767|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
460768|NCT00844545|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460769|NCT00844532|B1|Baseline|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460770|NCT00844532|P1|Participant Flow|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460771|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460772|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460773|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460774|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460775|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460776|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460777|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460778|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460779|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460960|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
462617|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
460781|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460782|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460783|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460784|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460785|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460786|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460787|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460788|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460789|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460790|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460791|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460792|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460793|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460794|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460795|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460796|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460797|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460798|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460799|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460800|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460801|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460961|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460962|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460802|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460803|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460804|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460805|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460806|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460807|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460808|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460809|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460810|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460811|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460812|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460813|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460814|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460815|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460816|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460817|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460818|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460819|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460820|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460821|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460822|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460963|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460964|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460823|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460824|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460825|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460826|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460827|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460828|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460829|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460830|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460831|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460832|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460833|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460834|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460835|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460836|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460837|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460838|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460839|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460840|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460841|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460842|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460843|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460965|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460966|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460844|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460845|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460846|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460847|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460848|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460849|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460850|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460851|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460852|NCT00844532|E1|Reported Event|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
460853|NCT00844519|B3|Baseline|Total|Total of all reporting groups
460854|NCT00844519|B2|Baseline|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
460855|NCT00844519|B1|Baseline|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
460856|NCT00844519|P2|Participant Flow|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
460857|NCT00844519|P1|Participant Flow|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
460858|NCT00844519|O2|Outcome|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
460859|NCT00844519|O1|Outcome|Maraviroc|maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
460860|NCT00844519|E2|Reported Event|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
460861|NCT00844519|E1|Reported Event|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
460862|NCT00844480|B3|Baseline|Total|Total of all reporting groups
460863|NCT00844480|B2|Baseline|Placebo|placebo: iv
460864|NCT00844480|B1|Baseline|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
460865|NCT00844480|P2|Participant Flow|Placebo|placebo: iv
460866|NCT00844480|P1|Participant Flow|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
460867|NCT00844480|O2|Outcome|Placebo|placebo: iv
460868|NCT00844480|O1|Outcome|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
460869|NCT00844480|O2|Outcome|Placebo|placebo: iv
460870|NCT00844480|O1|Outcome|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
460871|NCT00844480|E2|Reported Event|Placebo|placebo: iv
460872|NCT00844480|E1|Reported Event|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
460873|NCT00844428|B1|Baseline|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460874|NCT00844428|P1|Participant Flow|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460875|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460967|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460876|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460877|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460878|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460879|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460880|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460881|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460882|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460883|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460884|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460885|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460886|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460887|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460888|NCT00844428|E1|Reported Event|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
460889|NCT00844415|B1|Baseline|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
460968|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460890|NCT00844415|P1|Participant Flow|All Patients (Pat.)|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
460891|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
460892|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
460893|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
460894|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
460895|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
460896|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
460897|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
460898|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
460969|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460970|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460899|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
460900|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
460901|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
460902|NCT00844415|E1|Reported Event|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
460903|NCT00844376|B1|Baseline|All Participants|
460904|NCT00844376|P2|Participant Flow|Reference Drug First (Atorvastatin Tablet)|80-mg Commercial atorvastatin tablet (Lipitor®) as a single dose in the first intervention period and 80-mg EP suspension atorvastatin prototype formulation as a single dose in the second intervention period. Period 2 began immediately after period 1.
460905|NCT00844376|P1|Participant Flow|Test Drug First (Atorvastatin EP Suspension)|80-milligram (mg) Extemporaneous preparation (EP) suspension atorvastatin prototype formulation as a single dose in the first intervention period and commercial (reference) 80 mg atorvastatin tablet (Lipitor®) as a single dose in the second intervention period. Period 2 began immediately after period 1.
460906|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460907|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460908|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460909|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460910|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460911|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460912|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460913|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460914|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460915|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460916|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460917|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460918|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460919|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460920|NCT00844376|E2|Reported Event|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
460921|NCT00844376|E1|Reported Event|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
460922|NCT00844298|B1|Baseline|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
460971|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460972|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460973|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460974|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460975|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460976|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460923|NCT00844298|P1|Participant Flow|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
460924|NCT00844298|O1|Outcome|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
460925|NCT00844298|E1|Reported Event|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
460926|NCT00844194|B3|Baseline|Total|Total of all reporting groups
460927|NCT00844194|B2|Baseline|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460928|NCT00844194|B1|Baseline|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460929|NCT00844194|P2|Participant Flow|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460930|NCT00844194|P1|Participant Flow|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460931|NCT00844194|O4|Outcome|MDD+ Non-Responder|MDD+, not treatment responder. 60mg, after week 5 120mg DLX
460932|NCT00844194|O3|Outcome|MDD- Non-Responder|MDD-, not treatment responder. 60mg, after week 5 120mg DLX
460933|NCT00844194|O2|Outcome|MDD+ Responder|MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
460934|NCT00844194|O1|Outcome|MDD- Responder|MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
460935|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460936|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460937|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460938|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460939|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460940|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460941|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460942|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460943|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460944|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460945|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460946|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460947|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460948|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460949|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460950|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460951|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460952|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460953|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460954|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460955|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460956|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460957|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460958|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460959|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460978|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460979|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460980|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460981|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460982|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460983|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460984|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460985|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460986|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460987|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460988|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460989|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460990|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460991|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460992|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460993|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460994|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460995|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460996|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460997|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
460998|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
460999|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461000|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461001|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461002|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461003|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461004|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461005|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461006|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461007|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461008|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461009|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461010|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461011|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461012|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461013|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461014|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461015|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461016|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461017|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461018|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461019|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461020|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461021|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461022|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461023|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461024|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461025|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461026|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461027|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461028|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461029|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461030|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
462759|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
461031|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461032|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461033|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461034|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461035|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461036|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461037|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461038|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461039|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461040|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461041|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461042|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461043|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461044|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461045|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461046|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461047|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461048|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461049|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461050|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461051|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461052|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461053|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461054|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461055|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461056|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461057|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461058|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461059|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461060|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461061|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461062|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461063|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461064|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461065|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461066|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461067|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461068|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461069|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461070|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461071|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461072|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461073|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461074|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461075|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461076|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461077|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461078|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461079|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461080|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461081|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461082|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461083|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
462760|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
461084|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461085|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461086|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461087|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461088|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461089|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461090|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461091|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461092|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461093|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461094|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461095|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461096|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461097|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461098|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461099|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461100|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461101|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461102|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461103|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461104|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461105|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461106|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461107|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461108|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461109|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461110|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461111|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461112|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461113|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461114|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461115|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461116|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461117|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461118|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461119|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461120|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461121|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461122|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461123|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461124|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461125|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461126|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461127|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461128|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461129|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461130|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461131|NCT00844194|E2|Reported Event|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
461132|NCT00844194|E1|Reported Event|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
461133|NCT00844090|B3|Baseline|Total|Total of all reporting groups
461134|NCT00844090|B2|Baseline|Placebo|"placebo~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461135|NCT00844090|B1|Baseline|Methylphenidate|"methylphenidate~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461136|NCT00844090|P2|Participant Flow|Placebo|"placebo~placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461137|NCT00844090|P1|Participant Flow|Methylphenidate|"methylphenidate~methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461138|NCT00844090|O2|Outcome|Placebo|"placebo~Placebo tabs BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461139|NCT00844090|O1|Outcome|Methylphenidate|"methylphenidate~methylphenidate 10mg BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461140|NCT00844090|E2|Reported Event|Placebo|"placebo~Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461141|NCT00844090|E1|Reported Event|Methyphenidate|"methylphenidate~methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
461142|NCT00844051|B3|Baseline|Total|Total of all reporting groups
461143|NCT00844051|B2|Baseline|Intervention|"School-based Influenza Vaccination Program~School-based influenza vaccination program: School-based influenza vaccination program"
461144|NCT00844051|B1|Baseline|No Intervention|No school-based influenza vaccination program
461145|NCT00844051|P2|Participant Flow|Intervention|School-based Influenza Vaccination Program
461146|NCT00844051|P1|Participant Flow|No Intervention|No school-based influenza vaccination program
461147|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
461148|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
461149|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
461150|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
461151|NCT00844051|E2|Reported Event|Intervention|School-based Influenza Vaccination Program
461152|NCT00844051|E1|Reported Event|No Intervention|No school-based influenza vaccination program
461153|NCT00843986|B3|Baseline|Total|Total of all reporting groups
461154|NCT00843986|B2|Baseline|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461155|NCT00843986|B1|Baseline|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461156|NCT00843986|P2|Participant Flow|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461157|NCT00843986|P1|Participant Flow|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461158|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461159|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461160|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461161|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461162|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461163|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461164|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461165|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461166|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461167|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461168|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461169|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461170|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461171|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461172|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461173|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461174|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461175|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461176|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461177|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461178|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461179|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461180|NCT00843986|E2|Reported Event|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
461181|NCT00843986|E1|Reported Event|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
461182|NCT00843843|B3|Baseline|Total|Total of all reporting groups
461183|NCT00843843|B2|Baseline|3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
461184|NCT00843843|B1|Baseline|9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
461185|NCT00843843|P2|Participant Flow|3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days)|3 hour nap and 6 hour sleep (3days), then 9 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
461186|NCT00843843|P1|Participant Flow|9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days)|9 hour sleep (3days), then 3 hour nap and 6 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
461187|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
461188|NCT00843843|O1|Outcome|9 Hour Sleep|
461189|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
461190|NCT00843843|O1|Outcome|9 Hour Sleep|
461191|NCT00843843|E2|Reported Event|3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
461192|NCT00843843|E1|Reported Event|9 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
461193|NCT00843830|B1|Baseline|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
461194|NCT00843830|P1|Participant Flow|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
461195|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
461196|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
461197|NCT00843830|E1|Reported Event|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
461198|NCT00843778|B1|Baseline|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461199|NCT00843778|P1|Participant Flow|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461200|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461201|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461202|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461249|NCT00843635|O1|Outcome|Arm A - 10mg|Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
461250|NCT00843635|O1|Outcome|Arm A (Tadalafil 10mg) + Arm B (Tadalafil 20mg)|All participants enrolled to the two dosing arms, Arm A (Tadalafil 10 mg) and Arm B (Tadalafil 20 mg).
461203|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461204|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461205|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461206|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461207|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461208|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461209|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461210|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461211|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461212|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461213|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461214|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461251|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
461252|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
462265|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
461215|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461216|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461217|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461218|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461219|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461220|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461221|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461222|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461223|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461224|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461225|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461226|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461253|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461254|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
462266|NCT00840450|B1|Baseline|Paclitaxel and Imatinib Mesylate (Gleevec)|
461227|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461228|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461229|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
461230|NCT00843778|E1|Reported Event|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks."
461231|NCT00843713|B3|Baseline|Total|Total of all reporting groups
461232|NCT00843713|B2|Baseline|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461233|NCT00843713|B1|Baseline|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461234|NCT00843713|P2|Participant Flow|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461235|NCT00843713|P1|Participant Flow|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461236|NCT00843713|O2|Outcome|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461237|NCT00843713|O1|Outcome|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461238|NCT00843713|E2|Reported Event|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461239|NCT00843713|E1|Reported Event|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
461240|NCT00843635|B4|Baseline|Total|Total of all reporting groups
461241|NCT00843635|B3|Baseline|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
461242|NCT00843635|B2|Baseline|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461243|NCT00843635|B1|Baseline|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461244|NCT00843635|P3|Participant Flow|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
461245|NCT00843635|P2|Participant Flow|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461246|NCT00843635|P1|Participant Flow|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461247|NCT00843635|O3|Outcome|Arm C - Placebo|Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
461248|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
462761|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
461255|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461256|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461257|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
461258|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461259|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461260|NCT00843635|E3|Reported Event|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
461261|NCT00843635|E2|Reported Event|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461262|NCT00843635|E1|Reported Event|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
461263|NCT00843622|B3|Baseline|Total|Total of all reporting groups
461264|NCT00843622|B2|Baseline|Placebo Snus|Non-tobacco, non-nicotine placebo product
461265|NCT00843622|B1|Baseline|Active Snus|Tobacco-based, smokefree product
461266|NCT00843622|P2|Participant Flow|Placebo Snus|Non-tobacco, non-nicotine placebo product
461267|NCT00843622|P1|Participant Flow|Active Snus|Tobacco-based, smokefree product
461268|NCT00843622|O2|Outcome|Placebo Snus|Non-tobacco, non-nicotine placebo product
461269|NCT00843622|O1|Outcome|Active Snus|Tobacco-based, smokefree product
461270|NCT00843622|E2|Reported Event|Placebo Snus|Non-tobacco, non-nicotine placebo product
461271|NCT00843622|E1|Reported Event|Active Snus|Tobacco-based, smokefree product
461272|NCT00843518|B3|Baseline|Total|Total of all reporting groups
461273|NCT00843518|B2|Baseline|Placebo|Placebo orally twice daily for 12 weeks
461274|NCT00843518|B1|Baseline|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461275|NCT00843518|P2|Participant Flow|Placebo|Placebo orally twice daily for 12 weeks
461276|NCT00843518|P1|Participant Flow|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461277|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461278|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461279|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461280|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461281|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461282|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461283|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461284|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461285|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461286|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461287|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461288|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461289|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461290|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461291|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461292|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461293|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461294|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461295|NCT00843518|O2|Outcome|Placebo|Placebo orally twice daily for 12 weeks
461296|NCT00843518|O1|Outcome|LY451395|3 milligram (mg) LY451395 (mibampator) orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
461297|NCT00843518|E6|Reported Event|Placebo Post-Study|The 30-day period after a participant had taken the last dose of study drug, during which time serious adverse event (SAE) information was collected.
461298|NCT00843518|E5|Reported Event|LY451395 Post-Study|The 30-day period after a participant had taken the last dose of study drug, during which time serious adverse event (SAE) information was collected.
461299|NCT00843518|E4|Reported Event|Placebo Washout|A 1-week single-blind washout period after the acute period, during time which all randomized participants received placebo.
461300|NCT00843518|E3|Reported Event|LY451395 Washout|A 1-week single-blind washout period after the acute period, during which time all randomized participants received placebo.
461301|NCT00843518|E2|Reported Event|Placebo Acute Treatment|Placebo orally twice daily for 12 weeks
461302|NCT00843518|E1|Reported Event|LY451395 Acute Treatment|3 milligram (mg) LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate.
461303|NCT00843492|B3|Baseline|Total|Total of all reporting groups
461336|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461304|NCT00843492|B2|Baseline|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461305|NCT00843492|B1|Baseline|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461306|NCT00843492|P2|Participant Flow|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461307|NCT00843492|P1|Participant Flow|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461308|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461309|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461310|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461311|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461312|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461313|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461314|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461315|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461316|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461317|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461318|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461319|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461320|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461321|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461322|NCT00843492|E2|Reported Event|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
461323|NCT00843492|E1|Reported Event|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
461324|NCT00843479|B3|Baseline|Total|Total of all reporting groups
461325|NCT00843479|B2|Baseline|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461326|NCT00843479|B1|Baseline|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461327|NCT00843479|P2|Participant Flow|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461328|NCT00843479|P1|Participant Flow|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461329|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461330|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461331|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461332|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461333|NCT00843479|O2|Outcome|Middle-age NGT|Middle-age normoglycemic subjects 35 to 50 years old
461334|NCT00843479|O1|Outcome|Elderly NGT|Normoglycemic subjects 65-80 years old
461335|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461458|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461337|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461338|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461339|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461340|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461341|NCT00843479|E2|Reported Event|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
461342|NCT00843479|E1|Reported Event|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
461343|NCT00843466|B3|Baseline|Total|Total of all reporting groups
461344|NCT00843466|B2|Baseline|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
461345|NCT00843466|B1|Baseline|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
461346|NCT00843466|P2|Participant Flow|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
461347|NCT00843466|P1|Participant Flow|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
461348|NCT00843466|O2|Outcome|No Treatment|The control group continued to use their current cleanser for hand washing.
461349|NCT00843466|O1|Outcome|Mild Moisturizing Hand Cleanser Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
461350|NCT00843466|E2|Reported Event|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
461351|NCT00843466|E1|Reported Event|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
461352|NCT00843349|B5|Baseline|Total|Total of all reporting groups
461353|NCT00843349|B4|Baseline|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
461354|NCT00843349|B3|Baseline|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
461355|NCT00843349|B2|Baseline|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
461356|NCT00843349|B1|Baseline|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
461357|NCT00843349|P4|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate Placebo|no dietary intervention + Lanthanum Carbonate placebo
461358|NCT00843349|P3|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + Lanthanum Carbonate placebo
461359|NCT00843349|P2|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
461360|NCT00843349|P1|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate (LC)|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
461361|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
461362|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
461363|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
461364|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
461365|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
461366|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
461367|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
461368|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
461369|NCT00843349|E4|Reported Event|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
461370|NCT00843349|E3|Reported Event|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
461371|NCT00843349|E2|Reported Event|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
461372|NCT00843349|E1|Reported Event|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
461373|NCT00843310|B1|Baseline|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
461374|NCT00843310|P1|Participant Flow|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
461375|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
461376|NCT00843310|E1|Reported Event|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
461377|NCT00843284|B1|Baseline|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461459|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461460|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461378|NCT00843284|P1|Participant Flow|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461379|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461380|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461381|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461382|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461383|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461384|NCT00843284|E1|Reported Event|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
461385|NCT00843193|B3|Baseline|Total|Total of all reporting groups
461386|NCT00843193|B2|Baseline|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461387|NCT00843193|B1|Baseline|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461388|NCT00843193|P2|Participant Flow|GSK679586 10mg (Milligram)/kg(Kilogram)|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/ milliliter (mL). The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461389|NCT00843193|P1|Participant Flow|Placebo|Participants received a total of three once-monthly intravenous (IV) infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461390|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461391|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461392|NCT00843193|O1|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461393|NCT00843193|O1|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461394|NCT00843193|O1|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461395|NCT00843193|O1|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461396|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461397|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461398|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461461|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461462|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461399|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461400|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461401|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461402|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461403|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461404|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461405|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461406|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461407|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461408|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461409|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461410|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461411|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461412|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461413|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461414|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461415|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461463|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461464|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461465|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461416|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461417|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461418|NCT00843193|O2|Outcome|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461419|NCT00843193|O1|Outcome|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461420|NCT00843193|E2|Reported Event|GSK679586 10 mg/kg|Participants received a total of 3 once-monthly IV infusions of 10 mg/kg GSK679586 diluted with sterile, normal saline to a concentration of 25 mg/mL. The final solution volume was 40 to 60 mL, depending on participants weight. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461421|NCT00843193|E1|Reported Event|Placebo|Participants received a total of three once-monthly IV infusions of sodium chloride placebo in a volume matched to the volume that would had been administered if the participant had been randomized to active treatment in order to maintain the integrity of the study blind. The IV infusions were administered by qualified study personnel, and were administered over 1 hour using a programmable infusion pump.
461422|NCT00843180|B3|Baseline|Total|Total of all reporting groups
461423|NCT00843180|B2|Baseline|Control|usual care only as control arm hospital care during bone marrow transplant
461424|NCT00843180|B1|Baseline|Massage|massage and acupressure up to 3x/week for entire hospital stay
461425|NCT00843180|P2|Participant Flow|Control|usual care only as control arm hospital care during bone marrow transplant
461426|NCT00843180|P1|Participant Flow|Massage|massage and acupressure up to 3x/week for entire hospital stay
461427|NCT00843180|O2|Outcome|Control|
461428|NCT00843180|O1|Outcome|Massage|
461429|NCT00843180|O2|Outcome|Control|
461430|NCT00843180|O1|Outcome|Massage|
461431|NCT00843180|O2|Outcome|Control|
461432|NCT00843180|O1|Outcome|Massage|
461433|NCT00843180|O2|Outcome|Control|
461434|NCT00843180|O1|Outcome|Massage|
461435|NCT00843180|E2|Reported Event|Control|usual care only as control arm hospital care during bone marrow transplant
461436|NCT00843180|E1|Reported Event|Massage|massage and acupressure up to 3x/week for entire hospital stay
461437|NCT00843167|B3|Baseline|Total|Total of all reporting groups
461438|NCT00843167|B2|Baseline|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
461439|NCT00843167|B1|Baseline|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
461440|NCT00843167|P2|Participant Flow|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
461441|NCT00843167|P1|Participant Flow|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
461442|NCT00843167|O2|Outcome|Treatment|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
461443|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
461444|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
461445|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
461446|NCT00843167|O3|Outcome|Invasive Ductal Carcinoma Tissue; Ki-67|Sulforaphane Supplement= 7, Placebo= 6
461447|NCT00843167|O2|Outcome|DCIS Tissue; Ki-67|Sulforaphane Supplement= 6, Placebo = 13
461448|NCT00843167|O1|Outcome|Benign Tissue; Ki-67|Sulforaphane Supplement = 23, Placebo = 25
461449|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
461450|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
461451|NCT00843167|E2|Reported Event|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
461452|NCT00843167|E1|Reported Event|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
461453|NCT00843115|B1|Baseline|Donepezil|As per physician prescription
461454|NCT00843115|P1|Participant Flow|Donepezil|As per physician prescription
461455|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461456|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461457|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
461499|NCT00843050|B1|Baseline|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
461500|NCT00843050|P1|Participant Flow|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
461501|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
461502|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
461503|NCT00843050|O1|Outcome|P276-00|P276-00: All patients received P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there was progression of disease or unacceptable toxicity
461504|NCT00843050|E1|Reported Event|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
461505|NCT00843024|B5|Baseline|Total|Total of all reporting groups
461506|NCT00843024|B4|Baseline|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461507|NCT00843024|B3|Baseline|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461508|NCT00843024|B2|Baseline|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461509|NCT00843024|B1|Baseline|Placebo|A single matching placebo tablet taken within a 12-week period
461510|NCT00843024|P6|Participant Flow|Sumatriptan 85 mg/ Naproxen 500 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461511|NCT00843024|P5|Participant Flow|Sumatriptan 30 mg/ Naproxen 180 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461512|NCT00843024|P4|Participant Flow|Sumatriptan 10 mg/ Naproxen 60 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461513|NCT00843024|P3|Participant Flow|Placebo|After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
461514|NCT00843024|P2|Participant Flow|15 to 17 Years Age Group: Single-blind Phase|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
461515|NCT00843024|P1|Participant Flow|12 to 14 Years Age Group: Single-blind Phase|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
461516|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461517|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461518|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461519|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461520|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461521|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461522|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461523|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461524|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461525|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461526|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461527|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461528|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461529|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
461530|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461531|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461532|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461533|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461534|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461535|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461536|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461537|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461538|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461539|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461540|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461541|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461542|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461543|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461544|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461545|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461546|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461547|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461548|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461549|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461550|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461551|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461552|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461553|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461554|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461555|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461556|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461557|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461558|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461559|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461560|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461561|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461562|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461563|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461564|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461565|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461566|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461567|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461568|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461569|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461570|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461571|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
462762|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
461572|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461573|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
461574|NCT00843024|E5|Reported Event|Single-blind Run-In Phase Placebo|One tablet of single-blind placebo taken during the Run-In Phase
461575|NCT00843024|E4|Reported Event|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
461576|NCT00843024|E3|Reported Event|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
461577|NCT00843024|E2|Reported Event|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
461578|NCT00843024|E1|Reported Event|Placebo|A single matching double-blind placebo tablet taken within a 12-week period
461579|NCT00842985|B1|Baseline|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
461580|NCT00842985|P1|Participant Flow|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
461581|NCT00842985|O4|Outcome|Placebo+Placebo|Session where placebo THC and Placebo Modafinil were given.
461582|NCT00842985|O3|Outcome|Pla+Modafinil|Session where Placebo THC and Modafinil were given
461583|NCT00842985|O2|Outcome|THC+Placebo|Session where TCH and Placebo Modafinil were given
461584|NCT00842985|O1|Outcome|THC+Modafinil|Session where THC+Modafinil was given.
461585|NCT00842985|E1|Reported Event|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
461586|NCT00842946|B3|Baseline|Total|Total of all reporting groups
461587|NCT00842946|B2|Baseline|Habituation|Behavioral exposure within the context of habituation.
461588|NCT00842946|B1|Baseline|Acceptance|Behavioral exposure within the context of psychological acceptance.
461589|NCT00842946|P2|Participant Flow|Habituation|Behavioral exposure within the context of habituation.
461590|NCT00842946|P1|Participant Flow|Acceptance|Behavioral exposure within the context of psychological acceptance.
461591|NCT00842946|O2|Outcome|Habituation|Behavioral exposure within the context of habituation.
461592|NCT00842946|O1|Outcome|Acceptance|Behavioral exposure within the context of psychological acceptance.
461593|NCT00842946|E2|Reported Event|Habituation|Behavioral exposure within the context of habituation.
461594|NCT00842946|E1|Reported Event|Acceptance|Behavioral exposure within the context of psychological acceptance.
461595|NCT00842829|B3|Baseline|Total|Total of all reporting groups
461596|NCT00842829|B2|Baseline|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461597|NCT00842829|B1|Baseline|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461598|NCT00842829|P3|Participant Flow|FBT - Treatment and Continuation Periods|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
461599|NCT00842829|P2|Participant Flow|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461600|NCT00842829|P1|Participant Flow|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461601|NCT00842829|O4|Outcome|FBT - Continuation Period|The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
461602|NCT00842829|O3|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461603|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461604|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461605|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461606|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461607|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461608|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
462096|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
461609|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461610|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461611|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461612|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461613|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461614|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461615|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461616|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461617|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461618|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461619|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461620|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461621|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461622|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461623|NCT00842829|O2|Outcome|60 Minutes|Participant assessments of medication performance 60 minutes after dosing during the Treatment Period.
461624|NCT00842829|O1|Outcome|30 Minutes|Participant assessments of medication performance 30 minutes after dosing during the Treatment Period.
461625|NCT00842829|O2|Outcome|During Treatment Period|The treatment period included participants who identified an effective dose during the earlier study period and used that dose for BTP episodes during the Treatment Period.
461626|NCT00842829|O1|Outcome|During Titration Period|The titration period consisted of up to 7 days of treatment in which participants used increasing dosage of study drug in order to identify the effective dose for their breakthrough pain episodes.
461627|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461628|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461629|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
461630|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461631|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
461632|NCT00842829|E1|Reported Event|FBT - All Doses and Study Periods|Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg
461633|NCT00842751|B1|Baseline|All Study Participants|
461634|NCT00842751|P1|Participant Flow|Acyline + Testosterone Undecanoate + Placebo Finasteride|Acyline 300 mcg/kg +Testosterone Undecanoate 200 mg, BID orally + placebo finasteride
461635|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
461636|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
461637|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, twice daily (BID) orally + placebo finasteride
461638|NCT00842751|O3|Outcome|Acyline + Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
461639|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
461640|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg subcutaneous (SC) +Testosterone Undecanoate 200 mg, BID orally + Placebo finasteride
461641|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
461642|NCT00842751|O2|Outcome|Acyline +Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally
461643|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride
461644|NCT00842751|E3|Reported Event|Third Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily orally + Finasteride 1mg, twice a day, orally
461645|NCT00842751|E2|Reported Event|Second Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5mg, twice a day, orally
461646|NCT00842751|E1|Reported Event|First Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily, orally + Finasteride placebo, twice daily, orally
461647|NCT00842712|B8|Baseline|Total|Total of all reporting groups
461648|NCT00842712|B7|Baseline|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461649|NCT00842712|B6|Baseline|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461650|NCT00842712|B5|Baseline|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461651|NCT00842712|B4|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461652|NCT00842712|B3|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461653|NCT00842712|B2|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461654|NCT00842712|B1|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461655|NCT00842712|P7|Participant Flow|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461656|NCT00842712|P6|Participant Flow|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461657|NCT00842712|P5|Participant Flow|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461658|NCT00842712|P4|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461659|NCT00842712|P3|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461660|NCT00842712|P2|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461661|NCT00842712|P1|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461662|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461663|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461664|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461665|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461666|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461667|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461668|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461680|NCT00842712|O1|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461738|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461669|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461670|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461671|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461672|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461673|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461674|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461675|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461676|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461677|NCT00842712|O4|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461678|NCT00842712|O3|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461679|NCT00842712|O2|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461695|NCT00842608|P2|Participant Flow|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461681|NCT00842712|E7|Reported Event|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461682|NCT00842712|E6|Reported Event|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461683|NCT00842712|E5|Reported Event|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
461684|NCT00842712|E4|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461685|NCT00842712|E3|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461686|NCT00842712|E2|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461687|NCT00842712|E1|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
461688|NCT00842608|B5|Baseline|Total|Total of all reporting groups
461689|NCT00842608|B4|Baseline|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461690|NCT00842608|B3|Baseline|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
461691|NCT00842608|B2|Baseline|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461692|NCT00842608|B1|Baseline|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
461693|NCT00842608|P4|Participant Flow|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461694|NCT00842608|P3|Participant Flow|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
461696|NCT00842608|P1|Participant Flow|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
461697|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461698|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
461699|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461700|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
461701|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461702|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
461703|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461704|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
461705|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461706|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
461707|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461737|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
462261|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
461708|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
461709|NCT00842608|E4|Reported Event|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461710|NCT00842608|E3|Reported Event|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
461711|NCT00842608|E2|Reported Event|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
461712|NCT00842608|E1|Reported Event|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
461713|NCT00842543|B5|Baseline|Total|Total of all reporting groups
461714|NCT00842543|B4|Baseline|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
461715|NCT00842543|B3|Baseline|Overweight Placebo|Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
461716|NCT00842543|B2|Baseline|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
461717|NCT00842543|B1|Baseline|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
461718|NCT00842543|P4|Participant Flow|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
461719|NCT00842543|P3|Participant Flow|Overweight Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
461720|NCT00842543|P2|Participant Flow|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
461721|NCT00842543|P1|Participant Flow|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
461722|NCT00842543|O4|Outcome|Lean Placebo|
461723|NCT00842543|O3|Outcome|Overweight Placebo|Reesults displayed for overweight boys who received 6 months of Placebo intervention
461724|NCT00842543|O2|Outcome|Lean FVJC|
461725|NCT00842543|O1|Outcome|Overweight FVJC|Results displayed for overweight boys who received 6 months of FVJC intervention
461726|NCT00842543|O2|Outcome|Lean|Lean boys prior to receiving intervention.
461727|NCT00842543|O1|Outcome|Overweight|Overweight boys prior to receiving intervention.
461728|NCT00842543|E4|Reported Event|Lean Placebo|Lean Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
461729|NCT00842543|E3|Reported Event|Overweight Placebo|Overweight Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
461730|NCT00842543|E2|Reported Event|Lean FVJC|Lean Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
461731|NCT00842543|E1|Reported Event|Overweight FVJC|Overweight Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
461732|NCT00842361|B3|Baseline|Total|Total of all reporting groups
461733|NCT00842361|B2|Baseline|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461734|NCT00842361|B1|Baseline|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461735|NCT00842361|P2|Participant Flow|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461736|NCT00842361|P1|Participant Flow|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461858|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461739|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461740|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461741|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461742|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461743|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461744|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461745|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461746|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461747|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461748|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461749|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461750|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461751|NCT00842361|E2|Reported Event|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
461752|NCT00842361|E1|Reported Event|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
461753|NCT00842348|B3|Baseline|Total|Total of all reporting groups
461754|NCT00842348|B2|Baseline|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
461755|NCT00842348|B1|Baseline|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
461756|NCT00842348|P2|Participant Flow|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
461757|NCT00842348|P1|Participant Flow|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding double blind (DB) study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
461758|NCT00842348|O2|Outcome|Placebo - Randomised Treatment in Study 726|All patients randomised to placebo in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
461759|NCT00842348|O1|Outcome|Lanreotide Autogel - Randomised Treatment in Study 726|All patients randomised to lanreotide 120 mg (Autogel formulation) in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
461760|NCT00842348|O3|Outcome|Total|All patients treated with Lanreotide 120 mg (Autogel formulation) in the open label study.
461761|NCT00842348|O2|Outcome|Placebo|Patients who received placebo in the preceding double DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
461762|NCT00842348|O1|Outcome|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
461763|NCT00842348|E3|Reported Event|Total|All patients treated with lanreotide 120 mg (Autogel formulation) in the open label study.
461764|NCT00842348|E2|Reported Event|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
461765|NCT00842348|E1|Reported Event|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
461766|NCT00842335|B1|Baseline|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
461904|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
461767|NCT00842335|P1|Participant Flow|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
461768|NCT00842335|O1|Outcome|All Subjects|
461769|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
461770|NCT00842335|O1|Outcome|All Subjects|"The starting dose of JI-101 for patients in the first cohort was 100 mg QD. All patients took JI-101 without food on Day 0, with a high fat meal on Day 2, and with a regular diet on Day 3 onwards. Patients in the first three cohorts were dosed QD. Based on PK characteristics observed from the first eight patients (Cohort 1, Cohort 2, and Cohort 3), subsequent cohorts were dosed BID.~After the first eight patients, the combined PK profiles of the enrolled patients were studied. These assessments indicated that the PK profile for JI-101 supported BID dosing. Therefore, BID dosing was administered to patients who enrolled in the study following the effective date of Protocol"
461771|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
461772|NCT00842335|E1|Reported Event|JI-101|Maximum tolerated dose
461773|NCT00842296|B1|Baseline|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter.
461774|NCT00842296|P1|Participant Flow|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461775|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461776|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461777|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461778|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461779|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461780|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461781|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461782|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461783|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461784|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461785|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461786|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461787|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461788|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461789|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461790|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461791|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461792|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461793|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461794|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461795|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461796|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461797|NCT00842296|O1|Outcome|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461798|NCT00842296|E1|Reported Event|ClosureFAST® - Endovascular Radiofrequency Great Saphenous Vei|Single Arm with ClosureFAST (CLF) Catheter with an integrated healing element. Radiofrequency (RF) ablation (ClosureFAST): Segmental RF Ablation with the CLF catheter
461799|NCT00842257|B1|Baseline|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
461800|NCT00842257|P1|Participant Flow|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
461801|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
461802|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
461803|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
461804|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
461805|NCT00842257|E1|Reported Event|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
461806|NCT00842244|B1|Baseline|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461807|NCT00842244|P1|Participant Flow|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461808|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461905|NCT00841971|E2|Reported Event|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
461809|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461810|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461811|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461812|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461813|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461814|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461815|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461816|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461817|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461818|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461819|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461820|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461821|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461822|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461823|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461824|NCT00842244|E1|Reported Event|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
461825|NCT00842231|B1|Baseline|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
461826|NCT00842231|P1|Participant Flow|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
461827|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
461828|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
461829|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
461830|NCT00842231|E1|Reported Event|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
461831|NCT00842153|B3|Baseline|Total|Total of all reporting groups
461832|NCT00842153|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461833|NCT00842153|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461834|NCT00842153|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461835|NCT00842153|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461836|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461837|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461838|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461839|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461840|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461841|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461842|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461843|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461844|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461845|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461846|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461847|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461848|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461849|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461850|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461851|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461852|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461853|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461854|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461855|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461856|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461857|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461859|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461860|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461861|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461862|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461863|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461864|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461865|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461866|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461867|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461868|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461869|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461870|NCT00842153|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
461871|NCT00842153|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
461872|NCT00842075|B3|Baseline|Total|Total of all reporting groups
461873|NCT00842075|B2|Baseline|2 Usual Regimen|Usual bolus insulin dose at each meal
461874|NCT00842075|B1|Baseline|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
461875|NCT00842075|P2|Participant Flow|2 Usual Regimen|Usual bolus insulin dose at each meal
461876|NCT00842075|P1|Participant Flow|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
461877|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
461878|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
461879|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
461880|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
461881|NCT00842075|E2|Reported Event|2 Usual Regimen|Usual bolus insulin dose at each meal
461882|NCT00842075|E1|Reported Event|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
461883|NCT00842023|B3|Baseline|Total|Total of all reporting groups
461884|NCT00842023|B2|Baseline|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
461885|NCT00842023|B1|Baseline|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
461886|NCT00842023|P2|Participant Flow|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
461887|NCT00842023|P1|Participant Flow|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
461888|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
461889|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
461890|NCT00842023|O2|Outcome|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
461891|NCT00842023|O1|Outcome|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
461892|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
461893|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
461894|NCT00842023|E2|Reported Event|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
461895|NCT00842023|E1|Reported Event|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
461896|NCT00841971|B3|Baseline|Total|Total of all reporting groups
461897|NCT00841971|B2|Baseline|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
461898|NCT00841971|B1|Baseline|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
461899|NCT00841971|P2|Participant Flow|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
461900|NCT00841971|P1|Participant Flow|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
461901|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
461902|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
461903|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
462262|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
461906|NCT00841971|E1|Reported Event|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
461907|NCT00841906|B3|Baseline|Total|Total of all reporting groups
461908|NCT00841906|B2|Baseline|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461909|NCT00841906|B1|Baseline|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461910|NCT00841906|P2|Participant Flow|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461911|NCT00841906|P1|Participant Flow|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461912|NCT00841906|O2|Outcome|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461913|NCT00841906|O1|Outcome|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461914|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
461915|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
461916|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
461917|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
461918|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
461919|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
461920|NCT00841906|E2|Reported Event|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461968|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461969|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461921|NCT00841906|E1|Reported Event|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
461922|NCT00841815|B3|Baseline|Total|Total of all reporting groups
461923|NCT00841815|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
461924|NCT00841815|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
461925|NCT00841815|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
461926|NCT00841815|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
461927|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
461928|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
461929|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
461930|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
461931|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
461932|NCT00841815|O1|Outcome|Amlodipine Besylate|Amlodipine Besylate 10 mg tablet (test) dosed in either period
461933|NCT00841776|B3|Baseline|Total|Total of all reporting groups
461934|NCT00841776|B2|Baseline|Ziana|Clindamycin and topical tretinoin gel
461935|NCT00841776|B1|Baseline|Duac|Clindamycin and benzoyl peroxide topical gel
461936|NCT00841776|P2|Participant Flow|Ziana|Clindamycin and topical tretinoin gel
461937|NCT00841776|P1|Participant Flow|Duac|Clindamycin and benzoyl peroxide topical gel
461938|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
461939|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
461940|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
461941|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
461942|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
461943|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
461944|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
461945|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
461946|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
461947|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
461948|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
461949|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
461950|NCT00841776|E2|Reported Event|Ziana|Clindamycin and topical tretinoin gel
461951|NCT00841776|E1|Reported Event|Duac|Clindamycin and benzoyl peroxide topical gel
461952|NCT00841763|B3|Baseline|Total|Total of all reporting groups
461953|NCT00841763|B2|Baseline|PL+ aTIV|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
461954|NCT00841763|B1|Baseline|TIV + aH5N1|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1).
461955|NCT00841763|P4|Participant Flow|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
461956|NCT00841763|P3|Participant Flow|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
461957|NCT00841763|P2|Participant Flow|PL+ aTIV (18 to 60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
461958|NCT00841763|P1|Participant Flow|TIV + aH5N1 (18 to 60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
461959|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461960|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461961|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461962|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461963|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461964|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461965|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461966|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461967|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461970|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461971|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461972|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461973|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461974|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461975|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461976|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461977|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461978|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461979|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461980|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461981|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461982|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461983|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461984|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461985|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461986|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461987|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461988|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461989|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas ≥25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461990|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461991|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers ≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461992|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461993|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461994|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1).
461995|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461996|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
461997|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
461998|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
461999|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462000|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462001|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462002|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462003|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462004|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462005|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462006|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462007|NCT00841763|O4|Outcome|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
462008|NCT00841763|O3|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462009|NCT00841763|O2|Outcome|PL+ aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
462010|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462011|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462012|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
462013|NCT00841763|E4|Reported Event|PL+MF59-eTIV (>60yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
462014|NCT00841763|E3|Reported Event|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (MF59-eH5N1)
462015|NCT00841763|E2|Reported Event|PL+MF59-eTIV (18-60yrs)|First dose of placebo(PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
462016|NCT00841763|E1|Reported Event|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
462017|NCT00841698|B3|Baseline|Total|Total of all reporting groups
462018|NCT00841698|B2|Baseline|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
462019|NCT00841698|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
462020|NCT00841698|P2|Participant Flow|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
462021|NCT00841698|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
462022|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
462023|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
462024|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
462025|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
462026|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
462027|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
462028|NCT00841672|B3|Baseline|Total|Total of all reporting groups
462029|NCT00841672|B2|Baseline|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462030|NCT00841672|B1|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462031|NCT00841672|P2|Participant Flow|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462032|NCT00841672|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462033|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462034|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462035|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462036|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462037|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462038|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462091|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
462763|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462039|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462040|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462041|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462042|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462043|NCT00841672|E2|Reported Event|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
462044|NCT00841672|E1|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
462045|NCT00841659|B3|Baseline|Total|Total of all reporting groups
462046|NCT00841659|B2|Baseline|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
462047|NCT00841659|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
462048|NCT00841659|P2|Participant Flow|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
462049|NCT00841659|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
462050|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
462051|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
462052|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
462053|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
462054|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
462055|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
462056|NCT00841555|B4|Baseline|Total|Total of all reporting groups
462057|NCT00841555|B3|Baseline|Dose Level 3|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462058|NCT00841555|B2|Baseline|Dose Level 2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462059|NCT00841555|B1|Baseline|Dose Level 1|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462060|NCT00841555|P3|Participant Flow|Dose Level 3: 75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462061|NCT00841555|P2|Participant Flow|Dose Level 2: 65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462062|NCT00841555|P1|Participant Flow|Dose Level 1: 50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462092|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
462093|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
462094|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
462095|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
462063|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462064|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462065|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462066|NCT00841555|E3|Reported Event|75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462067|NCT00841555|E2|Reported Event|65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462068|NCT00841555|E1|Reported Event|50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
462069|NCT00841542|B3|Baseline|Total|Total of all reporting groups
462070|NCT00841542|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
462071|NCT00841542|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
462072|NCT00841542|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
462073|NCT00841542|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
462074|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
462075|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
462076|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
462077|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
462078|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
462079|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
462080|NCT00841412|B1|Baseline|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
462081|NCT00841412|P2|Participant Flow|Delayed Intervention Group/Units|Delayed Intervention units (control group) was monitored by research staff under usual care conditions.
462082|NCT00841412|P1|Participant Flow|Immediate Intervention Group/Units|Immediate Intervention units received a staff training and management intervention to improve daily nutritional care processes.
462083|NCT00841412|O1|Outcome|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so outcome measures are reported overall for both groups combined.
462084|NCT00841412|E1|Reported Event|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
462085|NCT00841321|B3|Baseline|Total|Total of all reporting groups
462086|NCT00841321|B2|Baseline|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
462087|NCT00841321|B1|Baseline|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
462088|NCT00841321|P2|Participant Flow|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
462089|NCT00841321|P1|Participant Flow|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
462090|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
462097|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
462098|NCT00841321|E2|Reported Event|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
462099|NCT00841321|E1|Reported Event|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
462100|NCT00841269|B3|Baseline|Total|Total of all reporting groups
462101|NCT00841269|B2|Baseline|Healthy Comparison|Participants assigned to this group were seen only at baseline and received no intervention.
462102|NCT00841269|B1|Baseline|Open Label Uridine Treatment|All participants were Caucasian. There were 5 female participants and 2 male participants.
462103|NCT00841269|P2|Participant Flow|Healthy Comparison|Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention.
462104|NCT00841269|P1|Participant Flow|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks. At each treatment visit, the following rating scales were administered: The CDRS-R, YMRS, and the Columbia-Suicide Severity Rating Scale (C-SSRS)
462105|NCT00841269|O2|Outcome|Healthy Comparison|Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention/treatment.
462106|NCT00841269|O1|Outcome|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks.
462107|NCT00841269|O2|Outcome|Healthy Comparison|Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention/treatment.
462108|NCT00841269|O1|Outcome|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks.
462109|NCT00841269|O2|Outcome|Healthy Comparison|Participants assigned to this group were seen for two scan visits (baseline and week 6). Healthy comparison participants received no intervention/treatment.
462110|NCT00841269|O1|Outcome|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks.
462111|NCT00841269|E1|Reported Event|Uridine 500 mg by Mouth Twice Daily for 6 Weeks|Because this was an open-label study, all participants received the investigational drug uridine.
462112|NCT00841204|B3|Baseline|Total|Total of all reporting groups
462113|NCT00841204|B2|Baseline|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462114|NCT00841204|B1|Baseline|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462115|NCT00841204|P2|Participant Flow|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462116|NCT00841204|P1|Participant Flow|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462117|NCT00841204|O2|Outcome|Arm II|"Participants receive oral placebo twice daily for 8 weeks~placebo: Inactive agent~laboratory biomarker analysis: Correlative studies"
462118|NCT00841204|O1|Outcome|Arm I|"Participants receive oral sulindac twice daily for 8 weeks~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
462119|NCT00841204|O2|Outcome|Arm II|"Participants receive oral placebo twice daily for 8 weeks~placebo: Inactive agent~laboratory biomarker analysis: Correlative studies"
462120|NCT00841204|O1|Outcome|Arm I|"Participants receive oral sulindac twice daily for 8 weeks~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
462121|NCT00841204|O2|Outcome|Arm II|"Participants receive oral placebo twice daily for 8 weeks~placebo: Inactive agent~laboratory biomarker analysis: Correlative studies"
462122|NCT00841204|O1|Outcome|Arm I|"Participants receive oral sulindac twice daily for 8 weeks~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
462123|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462124|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462125|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462126|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462127|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462128|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462129|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462130|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462131|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462132|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462133|NCT00841204|E2|Reported Event|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
462134|NCT00841204|E1|Reported Event|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
462135|NCT00841087|B3|Baseline|Total|Total of all reporting groups
462136|NCT00841087|B2|Baseline|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462137|NCT00841087|B1|Baseline|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462138|NCT00841087|P2|Participant Flow|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462139|NCT00841087|P1|Participant Flow|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462140|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462141|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462142|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462143|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462144|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462145|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462146|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462147|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462148|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462149|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462150|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462151|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462152|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462153|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462154|NCT00841087|E2|Reported Event|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462155|NCT00841087|E1|Reported Event|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
462156|NCT00841035|B1|Baseline|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
462157|NCT00841035|P1|Participant Flow|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
462158|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
462159|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
462160|NCT00841035|E1|Reported Event|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
462161|NCT00840996|B3|Baseline|Total|Total of all reporting groups
462162|NCT00840996|B2|Baseline|Placebo|Perioperative equal volume of saline placebo IV infusion
462163|NCT00840996|B1|Baseline|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462164|NCT00840996|P2|Participant Flow|Placebo|Perioperative equal volume of saline placebo IV infusion
462165|NCT00840996|P1|Participant Flow|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462166|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
462167|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462168|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
462169|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462170|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
462171|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462172|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
462173|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462174|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
462175|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462176|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
462177|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462178|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
462179|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462180|NCT00840996|E2|Reported Event|Placebo|Perioperative equal volume of saline placebo IV infusion
462181|NCT00840996|E1|Reported Event|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
462182|NCT00840879|B3|Baseline|Total|Total of all reporting groups
462183|NCT00840879|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
462184|NCT00840879|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
462185|NCT00840879|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
462186|NCT00840879|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
462187|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
462188|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
462189|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
462190|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
462191|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
462192|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
462193|NCT00840866|B3|Baseline|Total|Total of all reporting groups
462194|NCT00840866|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
462195|NCT00840866|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
462196|NCT00840866|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
462197|NCT00840866|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
462198|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
462199|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
462200|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
462201|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
462202|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
462203|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
462204|NCT00840840|B3|Baseline|Total|Total of all reporting groups
462205|NCT00840840|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
462206|NCT00840840|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
462207|NCT00840840|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
462208|NCT00840840|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
462209|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462210|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462211|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462212|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462213|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462214|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462215|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462216|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462217|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462218|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462219|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462220|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462221|NCT00840658|B5|Baseline|Total|Total of all reporting groups
462222|NCT00840658|B4|Baseline|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
462223|NCT00840658|B3|Baseline|C:Interactive Sexual Risk & Didactic Safer Injection Education|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI)and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a lecture-format presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
462224|NCT00840658|B2|Baseline|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
462225|NCT00840658|B1|Baseline|A: Didactic Safer Injection & Sexual Activity Education|In each city, 75 women will participate in a 60 minute lecture-format presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
462226|NCT00840658|P4|Participant Flow|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
462227|NCT00840658|P3|Participant Flow|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
462228|NCT00840658|P2|Participant Flow|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
462229|NCT00840658|P1|Participant Flow|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
462230|NCT00840658|O4|Outcome|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
462263|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
462264|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
462231|NCT00840658|O3|Outcome|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
462232|NCT00840658|O2|Outcome|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
462233|NCT00840658|O1|Outcome|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
462234|NCT00840658|E4|Reported Event|D: Interactive Injection and Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of MI and principles of SCT/TRA to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
462235|NCT00840658|E3|Reported Event|C:Interactive Sexual Risk Intervention & Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of MI and principles of SCT/TRA to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a didactic presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
462236|NCT00840658|E2|Reported Event|B: Interactive Injection Risk Intervention and Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
462237|NCT00840658|E1|Reported Event|A: Didactic Safer Injection and Sexual Activity Education|In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
462238|NCT00840632|B3|Baseline|Total|Total of all reporting groups
462239|NCT00840632|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
462240|NCT00840632|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
462241|NCT00840632|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
462242|NCT00840632|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
462243|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462244|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462245|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462246|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462247|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462248|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462249|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462250|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462251|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462252|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462253|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462254|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462255|NCT00840476|B3|Baseline|Total|Total of all reporting groups
462256|NCT00840476|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
462257|NCT00840476|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
462258|NCT00840476|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
462259|NCT00840476|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
462260|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
462764|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462267|NCT00840450|P1|Participant Flow|Paclitaxel and Imatinib Mesylate (Gleevec)|
462268|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
462269|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
462270|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
462271|NCT00840450|E1|Reported Event|Paclitaxel and Imatinib Mesylate (Gleevec)|
462272|NCT00840411|B3|Baseline|Total|Total of all reporting groups
462273|NCT00840411|B2|Baseline|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
462274|NCT00840411|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
462275|NCT00840411|P2|Participant Flow|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
462276|NCT00840411|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
462277|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
462278|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
462279|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
462280|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
462281|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
462282|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
462283|NCT00840307|B1|Baseline|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
462284|NCT00840307|P1|Participant Flow|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
462285|NCT00840307|O1|Outcome|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
462286|NCT00840307|E1|Reported Event|Patient With Gastric Band|20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
462287|NCT00840294|B3|Baseline|Total|Total of all reporting groups
462288|NCT00840294|B2|Baseline|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
462289|NCT00840294|B1|Baseline|Observation|Observation only for 2 weeks
462290|NCT00840294|P2|Participant Flow|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
462291|NCT00840294|P1|Participant Flow|Observation|Observation only for 2 weeks
462292|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
462293|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
462294|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
462295|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
462296|NCT00840294|E2|Reported Event|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
462297|NCT00840294|E1|Reported Event|Observation|Observation only for 2 weeks
462298|NCT00840281|B3|Baseline|Total|Total of all reporting groups
462299|NCT00840281|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
462300|NCT00840281|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
462301|NCT00840281|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
462302|NCT00840281|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
462303|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
462304|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
462305|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
462306|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
462307|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
462308|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
462309|NCT00840216|B3|Baseline|Total|Total of all reporting groups
462310|NCT00840216|B2|Baseline|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
462311|NCT00840216|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
462312|NCT00840216|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
462313|NCT00840216|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
462314|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
462315|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
462316|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
462317|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
462318|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
462765|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462319|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
462320|NCT00840203|B3|Baseline|Total|Total of all reporting groups
462321|NCT00840203|B2|Baseline|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
462322|NCT00840203|B1|Baseline|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
462323|NCT00840203|P2|Participant Flow|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
462324|NCT00840203|P1|Participant Flow|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
462325|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
462326|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
462327|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
462328|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
462329|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
462330|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
462331|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
462332|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
462333|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
462334|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
462335|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
462336|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
462337|NCT00840099|B3|Baseline|Total|Total of all reporting groups
462338|NCT00840099|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
462339|NCT00840099|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
462340|NCT00840099|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
462341|NCT00840099|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
462342|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462343|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462344|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462345|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462346|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462347|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462348|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462349|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462350|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462351|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462352|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
462353|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
462354|NCT00840086|B1|Baseline|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
462355|NCT00840086|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
462356|NCT00840086|O3|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
462357|NCT00840086|O2|Outcome|Part C|Surgery sub-trial: This part of the trial included any of the patients from Part A and Part B that during the course of the trial needed to undergo a major or minor surgical procedure requiring at least 7 days of daily FVIII treatment, including the day of surgery. Patients received a preoperative loading dose of turoctocog alfa immediately prior to the surgical procedure. On the day of surgery and until Day 7 (included) turoctocog alfa was dose adjusted aiming for a trough level above 0.50 IU/mL. Day 8 to last day of the surgical recovery period (if relevant) turoctocog alfa was dosed according to local guidelines.
462358|NCT00840086|O1|Outcome|Total (Part A + Part B)|Preventive treatment and treatment of bleeds: The doses were individualised based on the trough FVIII activity level. The doses could be adjusted by the investigator. The dose level chosen was 20-40 IU/kg every second day or 20-50 IU/kg three times per week (Part A + Part B). Subjects previously treated with turoctocog alpha were included in Part A.
462359|NCT00840086|O1|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
462766|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462360|NCT00840086|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
462361|NCT00840073|B3|Baseline|Total|Total of all reporting groups
462362|NCT00840073|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
462363|NCT00840073|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
462364|NCT00840073|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
462365|NCT00840073|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
462366|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462367|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462368|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462369|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462370|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462371|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462372|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462373|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462374|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
462375|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
462376|NCT00840060|B3|Baseline|Total|Total of all reporting groups
462377|NCT00840060|B2|Baseline|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
462378|NCT00840060|B1|Baseline|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
462379|NCT00840060|P2|Participant Flow|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
462380|NCT00840060|P1|Participant Flow|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
462381|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
462382|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
462383|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
462384|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
462385|NCT00840060|E2|Reported Event|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
462386|NCT00840060|E1|Reported Event|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
462387|NCT00840034|B3|Baseline|Total|Total of all reporting groups
462388|NCT00840034|B2|Baseline|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462389|NCT00840034|B1|Baseline|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462390|NCT00840034|P2|Participant Flow|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462391|NCT00840034|P1|Participant Flow|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets varying in strength) administered orally, once daily for up to 10 weeks, followed by a 2-week Taper Phase.
462392|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462393|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462394|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462395|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462396|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462397|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462398|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462399|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462400|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462465|NCT00839917|P1|Participant Flow|ProQuad™|Single subcutaneous 0.5 mL vaccination
462466|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462401|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462402|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462403|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462404|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462405|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462406|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462407|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462408|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462409|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462410|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462411|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462412|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462413|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462414|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462415|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462416|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462417|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462418|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462419|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462420|NCT00840034|O2|Outcome|Placebo|Placebo: 3 tablets PO QD for up to 12 weeks.
462421|NCT00840034|O1|Outcome|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
462422|NCT00840034|E4|Reported Event|Placebo-Taper Phase|Placebo: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks continued on placebo 3 tablets orally, once daily for 2 weeks.
462423|NCT00840034|E3|Reported Event|LY2216684-Taper Phase|LY2216684: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks were administered 12 mg orally, once daily for 1 week followed by 6 mg once daily for 1 week or 6 mg orally, once daily for 2 weeks.
462424|NCT00840034|E2|Reported Event|Placebo|Placebo: 3 tablets orally, once daily for up to 12 weeks.
462425|NCT00840034|E1|Reported Event|LY2216684|LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally, once daily for up to 10 weeks followed by a 2-week Taper Phase.
462426|NCT00839982|B1|Baseline|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462427|NCT00839982|P4|Participant Flow|Dose Level 4|"Patients receive clofarabine 30mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462428|NCT00839982|P3|Participant Flow|Dose Level 3|"Patients receive clofarabine 25mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462429|NCT00839982|P2|Participant Flow|Dose Level 2|"Patients receive clofarabine 20mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462430|NCT00839982|P1|Participant Flow|Dose Level 1|"Patients receive clofarabine 10mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462431|NCT00839982|O1|Outcome|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462432|NCT00839982|O1|Outcome|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462467|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462468|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462469|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462433|NCT00839982|O4|Outcome|Dose Level 4|"Patients receive clofarabine 30 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462434|NCT00839982|O3|Outcome|Dose Level 3|"Patients receive clofarabine 25 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462435|NCT00839982|O2|Outcome|Dose Level 2|"Patients receive clofarabine 20 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462436|NCT00839982|O1|Outcome|Dose Level 1|"Patients receive clofarabine 10 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462437|NCT00839982|O1|Outcome|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462438|NCT00839982|O4|Outcome|Dose Level 4|"Patients receive clofarabine 30 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462439|NCT00839982|O3|Outcome|Dose Level 3|"Patients receive clofarabine 25 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462440|NCT00839982|O2|Outcome|Dose Level 2|"Patients receive clofarabine 20 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462441|NCT00839982|O1|Outcome|Dose Level 1|"Patients receive clofarabine 10 mg PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO~cytarabine: Given SC"
462442|NCT00839982|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive clofarabine PO QD on days 1-5 and low-dose cytarabine SC BID on days 1-10 or SC QD on days 1-14. Treatment repeats every 21-28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~clofarabine: Given PO cytarabine: Given SC"
462443|NCT00839956|B1|Baseline|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
462444|NCT00839956|P1|Participant Flow|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
462445|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
462446|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
462447|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
462448|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
462449|NCT00839956|E1|Reported Event|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
462450|NCT00839930|B3|Baseline|Total|Total of all reporting groups
462451|NCT00839930|B2|Baseline|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
462452|NCT00839930|B1|Baseline|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
462453|NCT00839930|P2|Participant Flow|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
462454|NCT00839930|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
462455|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
462456|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
462457|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
462458|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
462459|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
462460|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
462461|NCT00839917|B3|Baseline|Total|Total of all reporting groups
462462|NCT00839917|B2|Baseline|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462463|NCT00839917|B1|Baseline|ProQuad™|Single subcutaneous 0.5 mL vaccination
462464|NCT00839917|P2|Participant Flow|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462767|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462470|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462471|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462472|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462473|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462474|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462475|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462476|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462477|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462478|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462479|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462480|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462481|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462482|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462483|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462484|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462485|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462486|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462487|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462488|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462489|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462490|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462491|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462492|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462493|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462494|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462495|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462496|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462497|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
462498|NCT00839917|E2|Reported Event|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
462499|NCT00839917|E1|Reported Event|ProQuad™|Single subcutaneous 0.5 mL vaccination
462500|NCT00839800|B3|Baseline|Total|Total of all reporting groups
462501|NCT00839800|B2|Baseline|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462502|NCT00839800|B1|Baseline|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462503|NCT00839800|P2|Participant Flow|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462504|NCT00839800|P1|Participant Flow|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462505|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462506|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462507|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462508|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462509|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462510|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462511|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462512|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462513|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462514|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462515|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462516|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462517|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462518|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462519|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462520|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462521|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462522|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462523|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462524|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462525|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462526|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462527|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462528|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462529|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462530|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462531|NCT00839800|E2|Reported Event|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
462532|NCT00839800|E1|Reported Event|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
462533|NCT00839540|B4|Baseline|Total|Total of all reporting groups
462534|NCT00839540|B3|Baseline|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
462535|NCT00839540|B2|Baseline|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
462536|NCT00839540|B1|Baseline|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
462537|NCT00839540|P3|Participant Flow|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
462538|NCT00839540|P2|Participant Flow|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
462539|NCT00839540|P1|Participant Flow|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
462540|NCT00839540|O3|Outcome|Log Inhibition of 200 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 200 mg/day dosing, measured as Ex-vivo effect.
462541|NCT00839540|O2|Outcome|Log Inhibition of 100 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 100 mg/day dosing, measured as Ex-vivo effect.
462542|NCT00839540|O1|Outcome|Log Inhibition of 50 mg/Day Caspofungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Caspofungin based on 50 mg/day dosing, measured as Ex-vivo effect.
462543|NCT00839540|E3|Reported Event|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
462544|NCT00839540|E2|Reported Event|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
462545|NCT00839540|E1|Reported Event|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
462546|NCT00839527|B4|Baseline|Total|Total of all reporting groups
462547|NCT00839527|B3|Baseline|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462548|NCT00839527|B2|Baseline|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462549|NCT00839527|B1|Baseline|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462550|NCT00839527|P3|Participant Flow|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462551|NCT00839527|P2|Participant Flow|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462552|NCT00839527|P1|Participant Flow|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462553|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462554|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462614|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462555|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462556|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462557|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462558|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462559|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462560|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462561|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462562|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462563|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462564|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462565|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462566|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462567|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462568|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462569|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462570|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462571|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462615|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462572|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462573|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462574|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462575|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462576|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462577|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462578|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462579|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462580|NCT00839527|E3|Reported Event|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462581|NCT00839527|E2|Reported Event|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462582|NCT00839527|E1|Reported Event|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
462583|NCT00839436|B4|Baseline|Total|Total of all reporting groups
462584|NCT00839436|B3|Baseline|20 mcg/kg Cohort|
462585|NCT00839436|B2|Baseline|10 mcg/kg Cohort|
462586|NCT00839436|B1|Baseline|3 mcg/kg Cohort|
462587|NCT00839436|P3|Participant Flow|20 mcg/kg Cohort|
462588|NCT00839436|P2|Participant Flow|10 mcg/kg Cohort|
462589|NCT00839436|P1|Participant Flow|3 mcg/kg Cohort|
462590|NCT00839436|O3|Outcome|20 mcg/kg Cohort|
462591|NCT00839436|O2|Outcome|10 mcg/kg Cohort|
462592|NCT00839436|O1|Outcome|3 mcg/kg Cohort|
462593|NCT00839436|E3|Reported Event|20 mcg/kg Cohort|
462594|NCT00839436|E2|Reported Event|10 mcg/kg Cohort|
462595|NCT00839436|E1|Reported Event|3 mcg/kg Cohort|
462596|NCT00839423|B5|Baseline|Total|Total of all reporting groups
462597|NCT00839423|B4|Baseline|Venlafaxine 225 mg|capsules, daily, orally
462598|NCT00839423|B3|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462599|NCT00839423|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462600|NCT00839423|B1|Baseline|Placebo|capsules, daily, orally
462601|NCT00839423|P4|Participant Flow|Venlafaxine 225 mg|capsules, daily, orally
462602|NCT00839423|P3|Participant Flow|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462603|NCT00839423|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462604|NCT00839423|P1|Participant Flow|Placebo|capsules, daily, orally
462605|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
462606|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462607|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462608|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
462609|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
462610|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462611|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462612|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
462613|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
462618|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462619|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462620|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
462621|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
462622|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462623|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462624|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
462625|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
462626|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462627|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462628|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
462629|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
462630|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462631|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462632|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
462633|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
462634|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
462635|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
462636|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
462637|NCT00839423|E4|Reported Event|Venlafaxine 225 mg|
462638|NCT00839423|E3|Reported Event|Vortioxetine 10 mg|
462639|NCT00839423|E2|Reported Event|Vortioxetine 5 mg|
462640|NCT00839423|E1|Reported Event|Placebo|
462641|NCT00839332|B4|Baseline|Total|Total of all reporting groups
462642|NCT00839332|B3|Baseline|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462643|NCT00839332|B2|Baseline|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462644|NCT00839332|B1|Baseline|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462645|NCT00839332|P3|Participant Flow|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462646|NCT00839332|P2|Participant Flow|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462647|NCT00839332|P1|Participant Flow|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 milligrams/meter squared (mg/m^2) LY2603618 as a 1-hour continuous intravenous (IV) infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462648|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462649|NCT00839332|O1|Outcome|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462695|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
462768|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462650|NCT00839332|O2|Outcome|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462651|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462652|NCT00839332|O1|Outcome|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70-250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462653|NCT00839332|O2|Outcome|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462654|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462655|NCT00839332|O2|Outcome|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462656|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462657|NCT00839332|O2|Outcome|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462658|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462659|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462660|NCT00839332|O1|Outcome|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462661|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462662|NCT00839332|O1|Outcome|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462696|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
462769|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462663|NCT00839332|O2|Outcome|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462664|NCT00839332|O1|Outcome|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462665|NCT00839332|O1|Outcome|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70-250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462666|NCT00839332|E3|Reported Event|Phase 2: Gemcitabine|Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.
462667|NCT00839332|E2|Reported Event|Phase 2: LY2603618 + Gemcitabine|"LY2603618: 230 mg flat dose LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.~Gemcitabine: Participants were administered 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462668|NCT00839332|E1|Reported Event|Phase 1: LY2603618 + Gemcitabine|"All participants in Phase 1 received LY2603618 in combination with gemcitabine.~LY2603618: 70 to 250 mg/m^2 LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received LY2603618 as part of the dose escalation cohort of Phase 1 (dose of 70, 105, 150, 200, or 250 mg/m^2) or as part of the expansion cohort of Phase 1 (flat dose of 200 or 230 mg). The flat dose cohorts were conducted in parallel.~Gemcitabine: 1000 mg/m^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression. Participants received gemcitabine 24 hours prior to LY2603618 administration."
462669|NCT00839319|B6|Baseline|Total|Total of all reporting groups
462670|NCT00839319|B5|Baseline|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
462671|NCT00839319|B4|Baseline|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
462672|NCT00839319|B3|Baseline|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
462673|NCT00839319|B2|Baseline|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
462674|NCT00839319|B1|Baseline|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
462675|NCT00839319|P5|Participant Flow|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
462676|NCT00839319|P4|Participant Flow|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
462677|NCT00839319|P3|Participant Flow|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
462678|NCT00839319|P2|Participant Flow|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
462679|NCT00839319|P1|Participant Flow|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
462680|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
462681|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
462682|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
462683|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
462684|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
462685|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
462686|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
462687|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
462688|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
462689|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
462690|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
462691|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
462692|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
462693|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
462694|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
462758|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462697|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
462698|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
462699|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
462700|NCT00839319|E5|Reported Event|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
462701|NCT00839319|E4|Reported Event|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
462702|NCT00839319|E3|Reported Event|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
462703|NCT00839319|E2|Reported Event|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
462704|NCT00839319|E1|Reported Event|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
462705|NCT00839306|B3|Baseline|Total|Total of all reporting groups
462706|NCT00839306|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462707|NCT00839306|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462708|NCT00839306|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462709|NCT00839306|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462710|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462711|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462712|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose inlcuded 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462713|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462714|NCT00839306|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462715|NCT00839306|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
462716|NCT00839241|B3|Baseline|Total|Total of all reporting groups
462717|NCT00839241|B2|Baseline|Allogenic Blood Transfusion|
462718|NCT00839241|B1|Baseline|Autologous Blood Transfusion|
462719|NCT00839241|P2|Participant Flow|Allogenic Blood Transfusion|
462720|NCT00839241|P1|Participant Flow|Autologous Blood Transfusion|
462721|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462722|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462723|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462724|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462725|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462726|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462727|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462728|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462729|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462730|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462731|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462732|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462733|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462734|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462735|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462736|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462737|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462738|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462739|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462740|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462741|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462742|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462743|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462744|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462745|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462746|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462747|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462748|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462749|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462750|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462751|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462752|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462753|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462754|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462755|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462756|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462757|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462770|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462771|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462772|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462773|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462774|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462775|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462776|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462777|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462778|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462779|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462780|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462781|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462782|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462783|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462784|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462785|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462786|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462787|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462788|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462789|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462790|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462791|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462792|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462793|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462794|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462795|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462796|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462797|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462798|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462799|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
462800|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
462801|NCT00839241|E2|Reported Event|Allogenic Blood Transfusion|
462802|NCT00839241|E1|Reported Event|Autologous Blood Transfusion|
462803|NCT00839098|B4|Baseline|Total|Total of all reporting groups
462804|NCT00839098|B3|Baseline|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
462805|NCT00839098|B2|Baseline|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
462806|NCT00839098|B1|Baseline|Control Group|Control Group
462807|NCT00839098|P3|Participant Flow|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
462808|NCT00839098|P2|Participant Flow|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
462809|NCT00839098|P1|Participant Flow|Control Group|Control Group
462810|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
462811|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
462812|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
462813|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
462814|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
462815|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
463059|NCT00838539|E2|Reported Event|N120 + T25|Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly
462816|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
462817|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
462818|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
462819|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
462820|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
462821|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
462822|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
462823|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
462824|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
462825|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
462826|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
462827|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
462828|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
462829|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
462830|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
462831|NCT00839098|E3|Reported Event|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
462832|NCT00839098|E2|Reported Event|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
462833|NCT00839098|E1|Reported Event|Control Group|Control Group
462834|NCT00839072|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
462835|NCT00839072|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 * 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone Contramid® OAD (Once-A-Day) 300 mg Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
462836|NCT00839072|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"1 * 300 mg Trazodone Contramid® OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Trazodone IR (Desyrel®) 100 mg tablet 8-hourly reference product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
462837|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462838|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462997|NCT00838578|O2|Outcome|Regimen B: KRN330 Weekly + Irinotecan Biweekly|treatment regimen B, KRN330 was administered weekly (Weeks 1, 2, 3, 4 and 5) and irinotecan (180 mg/m2) biweekly (Weeks 1, 3, and 5).
463060|NCT00838539|E1|Reported Event|N120 + T15|Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly
462839|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462840|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462841|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462842|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462843|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462844|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462845|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462846|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462847|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462848|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462849|NCT00839072|E2|Reported Event|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462850|NCT00839072|E1|Reported Event|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
462851|NCT00838981|B5|Baseline|Total|Total of all reporting groups
462852|NCT00838981|B4|Baseline|Sugar Pill Plus Voucher Control|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug"
462853|NCT00838981|B3|Baseline|Sugar Pill Plus CM|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug"
462854|NCT00838981|B2|Baseline|Modafinil Plus Voucher Control|"Modafinil from 200mg up to 400mg~Modafinil: Modafinil will be phase in from 200mg to 400mg"
462855|NCT00838981|B1|Baseline|Modafinil Plus CM|"Modafinil from 200mg up to 400mg~Modafinil: Modafinil will be phase in from 200mg to 400mg"
462856|NCT00838981|P4|Participant Flow|Placebo Plus Contingency Management|Sugar pill plus contingency management
462857|NCT00838981|P3|Participant Flow|Placebo Plus Voucher Control|Sugar pill plus voucher control
462858|NCT00838981|P2|Participant Flow|Modafinil Plus Voucher Control|Modafinil from 200mg up to 400mg plus the voucher control
462859|NCT00838981|P1|Participant Flow|Modafinil Plus Contingency Management|"Modafinil from 200mg up to 400mg~Modafinil: Modafinil will be phase in from 200mg to 400mg"
463053|NCT00838539|E8|Reported Event|N160 + T75|Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly
463054|NCT00838539|E7|Reported Event|N160 + T50|Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly
462860|NCT00838981|O4|Outcome|Sugar Pill Plus Voucher Control|"Sugar Pill: placebo, sugar pill will mirror active drug~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth."
462861|NCT00838981|O3|Outcome|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth."
462862|NCT00838981|O2|Outcome|Sugar Pill Plus Contingency Management|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462863|NCT00838981|O1|Outcome|Modafinil Plus Contingency Magagement|"Modafinil from 200mg up to 400mg plus Contingency Management~Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462864|NCT00838981|O4|Outcome|Sugar Pill Plus Voucher Control|"Sugar Pill: placebo, sugar pill will mirror active drug~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth."
462865|NCT00838981|O3|Outcome|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Methadone: Subjects will be started on 30 mg of methadone and the dose will be increased as tolerated to reach 60 mg at the end of the first 1-2 weeks of the induction phase. Methadone dosing will bestabilized. During methadone maintenance (weeks 1-11 of treatment phase), subjects continue to receive their maintenance doses of methadone plus modafinil or placebo.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth."
462866|NCT00838981|O2|Outcome|Sugar Pill Plus Contingency Management|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462867|NCT00838981|O1|Outcome|Modafinil Plus Contingency Magagement|"Modafinil from 200mg up to 400mg plus Contingency Management~Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462868|NCT00838981|O4|Outcome|Sugar Pill Plus Voucher Control|"Sugar Pill: placebo, sugar pill will mirror active drug~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b"
462869|NCT00838981|O3|Outcome|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the"
462870|NCT00838981|O2|Outcome|Sugar Pill Plus Contingency Management|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462871|NCT00838981|O1|Outcome|Modafinil Plus Contingency Magagement|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462872|NCT00838981|E4|Reported Event|Sugar Pill Plus Voucher Control|"Sugar Pill: placebo, sugar pill will mirror active drug~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b"
462873|NCT00838981|E3|Reported Event|Modafinil Plus Voucher Control|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the"
462874|NCT00838981|E2|Reported Event|Sugar Pill Plus Contingency Management|"Placebo: sugar pill~Sugar Pill: placebo, sugar pill will mirror active drug~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462875|NCT00838981|E1|Reported Event|Modafinil Plus Contingency Magagement|"Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.~Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample."
462876|NCT00838929|B4|Baseline|Total|Total of all reporting groups
462877|NCT00838929|B3|Baseline|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462878|NCT00838929|B2|Baseline|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462879|NCT00838929|B1|Baseline|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462880|NCT00838929|P3|Participant Flow|Vorinostat (400 mg) and Radiation|
462881|NCT00838929|P2|Participant Flow|Vorinostat (300 mg) and Radiation|
462882|NCT00838929|P1|Participant Flow|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462883|NCT00838929|O1|Outcome|Vorinostat and Radiation - All Participants|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462884|NCT00838929|E3|Reported Event|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462885|NCT00838929|E2|Reported Event|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462886|NCT00838929|E1|Reported Event|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
462887|NCT00838916|B3|Baseline|Total|Total of all reporting groups
462888|NCT00838916|B2|Baseline|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462889|NCT00838916|B1|Baseline|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
463055|NCT00838539|E6|Reported Event|N160 + T25|Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly
462890|NCT00838916|P2|Participant Flow|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462891|NCT00838916|P1|Participant Flow|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462892|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462893|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462894|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462895|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462896|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462897|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462898|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462899|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462900|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462901|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462902|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462903|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462904|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462905|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462906|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
463056|NCT00838539|E5|Reported Event|N160 + T15|Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly
462907|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462908|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462909|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462910|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462911|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462912|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462913|NCT00838916|E2|Reported Event|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462914|NCT00838916|E1|Reported Event|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462915|NCT00838903|B5|Baseline|Total|Total of all reporting groups
462916|NCT00838903|B4|Baseline|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462917|NCT00838903|B3|Baseline|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462918|NCT00838903|B2|Baseline|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462919|NCT00838903|B1|Baseline|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462920|NCT00838903|P4|Participant Flow|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462921|NCT00838903|P3|Participant Flow|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462922|NCT00838903|P2|Participant Flow|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462923|NCT00838903|P1|Participant Flow|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462924|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
463057|NCT00838539|E4|Reported Event|N120 + T75|Neratinib 120 mg qd + Temsirolimus 75mg, IV, weekly
463061|NCT00838526|B3|Baseline|Total|Total of all reporting groups
462925|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462926|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462927|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462928|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462929|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462930|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462931|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462932|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462933|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462934|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462935|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462936|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462937|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462938|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462939|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462940|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462941|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462942|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
463058|NCT00838539|E3|Reported Event|N120 + T50|Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly
462943|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462944|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462945|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462946|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462947|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462948|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462949|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462950|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462951|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462952|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462953|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462954|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462955|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462956|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462957|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462958|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462959|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462960|NCT00838903|E4|Reported Event|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
463959|NCT00835861|B3|Baseline|Total|Total of all reporting groups
462961|NCT00838903|E3|Reported Event|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462962|NCT00838903|E2|Reported Event|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462963|NCT00838903|E1|Reported Event|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
462964|NCT00838682|B3|Baseline|Total|Total of all reporting groups
462965|NCT00838682|B2|Baseline|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462966|NCT00838682|B1|Baseline|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462967|NCT00838682|P2|Participant Flow|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462968|NCT00838682|P1|Participant Flow|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462969|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462970|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462971|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462972|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462973|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462974|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462975|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462976|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462977|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462978|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462979|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462980|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462981|NCT00838682|E2|Reported Event|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462982|NCT00838682|E1|Reported Event|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
462983|NCT00838630|B3|Baseline|Total|Total of all reporting groups
462984|NCT00838630|B2|Baseline|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
462985|NCT00838630|B1|Baseline|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
462986|NCT00838630|P2|Participant Flow|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
462987|NCT00838630|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
462988|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
462989|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
462990|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
462991|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
462992|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
462993|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
462994|NCT00838578|B1|Baseline|KRN330 + Irinotecan|open label, single arm
462995|NCT00838578|P1|Participant Flow|KRN330 + Irinotecan|"Phase 1____ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)~Phase 2____ Weekly KRN330 (0.5 mg/kg)) (N=46)~Phase 1 and 2Combined (N=65)"
462996|NCT00838578|O3|Outcome|PH 2 Treatment: KRN330 Wkly + IRI Biwkly|The Phase 2 portion was a single arm study using the regimen and dose selected in Phase 1 (0.5 mg/kg KRN330 weekly and 180 mg/m2 irinotecan biweekly).
462998|NCT00838578|O1|Outcome|Regimen A: KRN330 Biweekly + Irinotecan Biweekly|"In treatment regimen A, both KRN330 and irinotecan (180 mg/m2) were administered biweekly(Weeks 1, 3, and 5).~Cohort 1: 1 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly Cohort 2: 0.5 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly"
462999|NCT00838578|E3|Reported Event|Phase 2: KRN330 Weekly + IRI Biweekly|The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion
463000|NCT00838578|E2|Reported Event|Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly|In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)
463001|NCT00838578|E1|Reported Event|Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly|"In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):~Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2"
463002|NCT00838539|B13|Baseline|Total|Total of all reporting groups
463003|NCT00838539|B12|Baseline|N240 + T15|Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
463004|NCT00838539|B11|Baseline|N200 + T50|Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly
463005|NCT00838539|B10|Baseline|N200 + T25|Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly
463006|NCT00838539|B9|Baseline|N200 + T15|Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly
463007|NCT00838539|B8|Baseline|N160 + T75|Neratinib 160 mg qd + Temsirolimus 75 mg, IV, weekly
463008|NCT00838539|B7|Baseline|N160 + T50|Neratinib 160 mg qd + Temsirolimus 50 mg, IV, weekly
463009|NCT00838539|B6|Baseline|N160 + T25|Neratinib 160 mg qd + Temsirolimus 25 mg, IV, weekly
463010|NCT00838539|B5|Baseline|N160 + T15|Neratinib 160 mg qd + Temsirolimus 15 mg, IV, weekly
463011|NCT00838539|B4|Baseline|N120 + T75|Neratinib 120 mg qd + Temsirolimus 75mg, IV, weekly
463012|NCT00838539|B3|Baseline|N120 + T50|Neratinib 120 mg qd + Temsirolimus 50 mg, IV, weekly
463013|NCT00838539|B2|Baseline|N120 + T25|Neratinib 120 mg qd + Temsirolimus 25 mg, IV, weekly
463014|NCT00838539|B1|Baseline|N120 + T15|Neratinib 120 mg qd + Temsirolimus 15 mg, IV, weekly
463015|NCT00838539|P12|Participant Flow|N240 + T15|Neratinib 240 mg + Temsirolimus 15 mg
463016|NCT00838539|P11|Participant Flow|N200 + T50|Neratinib 200 mg + Temsirolimus 50 mg
463017|NCT00838539|P10|Participant Flow|N200 + T25|Neratinib 200 mg + Temsirolimus 25 mg
463018|NCT00838539|P9|Participant Flow|N200 + T15|Neratinib 200 mg + Temsirolimus 15 mg
463019|NCT00838539|P8|Participant Flow|N160 + T75|Neratinib 160 mg + Temsirolimus 75 mg
463020|NCT00838539|P7|Participant Flow|N160 + T50|Neratinib 160 mg + Temsirolimus 50 mg
463021|NCT00838539|P6|Participant Flow|N160 + T25|Neratinib 160 mg + Temsirolimus 25 mg
463022|NCT00838539|P5|Participant Flow|N160 + T15|Neratinib 160 mg + Temsirolimus 15 mg
463023|NCT00838539|P4|Participant Flow|N120 + T75|Neratinib 120 mg + Temsirolimus 75 mg
463024|NCT00838539|P3|Participant Flow|N120 + T50|Neratinib 120 mg + Temsirolimus 50 mg
463025|NCT00838539|P2|Participant Flow|N120 + T25|Neratinib 120 mg + Temsirolimus 25 mg
463026|NCT00838539|P1|Participant Flow|N120 + T15|Neratinib 120 mg + Temsirolimus 15 mg
463027|NCT00838539|O4|Outcome|Temsirolums 75 mg|Neratinib at indicated dose levels with Temsirolimus 75 mg, IV, once weekly
463028|NCT00838539|O3|Outcome|Temsirolimus 50 mg|Neratinib at indicated dose levels with Temsirolimus 50 mg, IV, once weekly
463029|NCT00838539|O2|Outcome|Temsirolimus 25 mg|Neratinib at indicated dose levels with Temsirolimus 15 mg, IV, once weekly
463030|NCT00838539|O1|Outcome|Temsirolimus 15 mg|Neratinib at indicated dose levels with Temsirolimus 15 mg, IV, once weekly
463031|NCT00838539|O4|Outcome|Neratinib 240 mg + Temsirolimus|Neratinib 240 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463032|NCT00838539|O3|Outcome|Neratinib 200 mg + Temsirolimus|Neratinib 200 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463033|NCT00838539|O2|Outcome|Neratinib 160 mg + Temsirolimus|Neratinib 160 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463034|NCT00838539|O1|Outcome|Neratinib 120 mg + Temsirolimus|Neratinib 120 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463035|NCT00838539|O4|Outcome|Neratinib 240 mg + Temsirolimus|Neratinib 240 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463036|NCT00838539|O3|Outcome|Neratinib 200 mg + Temsirolimus|Neratinib 200 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463037|NCT00838539|O2|Outcome|Neratinib 160 mg + Temsirolimus|Neratinib 160 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463038|NCT00838539|O1|Outcome|Neratinib 120 mg + Temsirolimus|Neratinib 120 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463039|NCT00838539|O4|Outcome|Neratinib 240 mg + Temsirolimus|Neratinib 240 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463040|NCT00838539|O3|Outcome|Neratinib 200 mg + Temsirolimus|Neratinib 200 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463041|NCT00838539|O2|Outcome|Neratinib 160 mg + Temsirolimus|Neratinib 160 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463042|NCT00838539|O1|Outcome|Neratinib 120 mg + Temsirolimus|Neratinib 120 mg, qd, with various dose levels of temsirolimus, IV, once weekly.
463043|NCT00838539|O2|Outcome|MTD TEMS With Ner|Temsirolimus MTD in combination with neratinib.
463044|NCT00838539|O1|Outcome|MTD Ner With TEMS|Neratinib MTD in combination with Temsirolimus
463045|NCT00838539|O4|Outcome|Neratinib 240 mg|Neratinib 240 mg/day with indicated level of Temsirolimus, weekly, IV.
463046|NCT00838539|O3|Outcome|Neratinib 200 mg|Neratinib 200 mg/day with indicated level of Temsirolimus, weekly, IV.
463047|NCT00838539|O2|Outcome|Neratinib 160 mg|Neratinib 160 mg/day with indicated level of Temsirolimus, weekly, IV.
463048|NCT00838539|O1|Outcome|Neratinib 120 mg|Neratinib 120 mg/day with indicated level of Temsirolimus, weekly, IV.
463049|NCT00838539|E12|Reported Event|N240 + T15|Neratinib 240 mg qd + Temsirolimus 15 mg, IV, weekly
463050|NCT00838539|E11|Reported Event|N200 + T50|Neratinib 200 mg qd + Temsirolimus 50 mg, IV, weekly
463051|NCT00838539|E10|Reported Event|N200 + T25|Neratinib 200 mg qd + Temsirolimus 25 mg, IV, weekly
463052|NCT00838539|E9|Reported Event|N200 + T15|Neratinib 200 mg qd + Temsirolimus 15 mg, IV, weekly
463062|NCT00838526|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463063|NCT00838526|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463064|NCT00838526|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463065|NCT00838526|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463066|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463067|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463068|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463069|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463070|NCT00838526|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463071|NCT00838526|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
463072|NCT00838513|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463073|NCT00838513|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463074|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463075|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463076|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463077|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463078|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463079|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463080|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463105|NCT00838201|B1|Baseline|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
465926|NCT00832455|O2|Outcome|Montelukast ITT at Week 8|
463081|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463082|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463083|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463084|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463085|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463086|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463087|NCT00838513|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
463088|NCT00838331|B1|Baseline|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
463089|NCT00838331|P1|Participant Flow|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
463090|NCT00838331|O1|Outcome|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
463091|NCT00838331|E1|Reported Event|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
463092|NCT00838279|B3|Baseline|Total|Total of all reporting groups
463093|NCT00838279|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
463094|NCT00838279|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
463095|NCT00838279|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
463096|NCT00838279|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
463097|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
463098|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
463099|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
463100|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
463101|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
463102|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
463103|NCT00838201|B3|Baseline|Total|Total of all reporting groups
463104|NCT00838201|B2|Baseline|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
463156|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463106|NCT00838201|P2|Participant Flow|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
463107|NCT00838201|P1|Participant Flow|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
463108|NCT00838201|O2|Outcome|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
463109|NCT00838201|O1|Outcome|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
463110|NCT00838201|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
463111|NCT00838201|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
463112|NCT00838162|B5|Baseline|Total|Total of all reporting groups
463113|NCT00838162|B4|Baseline|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463114|NCT00838162|B3|Baseline|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463115|NCT00838162|B2|Baseline|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463116|NCT00838162|B1|Baseline|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463117|NCT00838162|P4|Participant Flow|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463118|NCT00838162|P3|Participant Flow|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463119|NCT00838162|P2|Participant Flow|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463120|NCT00838162|P1|Participant Flow|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463121|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463122|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463123|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463124|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463125|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463126|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463127|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463128|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463129|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463130|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463131|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463132|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463133|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463134|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463135|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463136|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463137|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463138|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463139|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463140|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463141|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463142|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463143|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463144|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463145|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463146|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463147|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463148|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463149|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463150|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463151|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463152|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463153|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463154|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463155|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
464208|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
463157|NCT00838162|E4|Reported Event|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
463158|NCT00838162|E3|Reported Event|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
463159|NCT00838162|E2|Reported Event|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
463160|NCT00838162|E1|Reported Event|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
463161|NCT00838136|B3|Baseline|Total|Total of all reporting groups
463162|NCT00838136|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
463163|NCT00838136|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
463164|NCT00838136|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
463165|NCT00838136|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
463166|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
463167|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
463168|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
463169|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
463170|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
463171|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
463172|NCT00838110|B3|Baseline|Total|Total of all reporting groups
463173|NCT00838110|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
463174|NCT00838110|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
463175|NCT00838110|P4|Participant Flow|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
463176|NCT00838110|P3|Participant Flow|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
463177|NCT00838110|P2|Participant Flow|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
463178|NCT00838110|P1|Participant Flow|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
463179|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
463180|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
463181|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
463182|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
463183|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
463184|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
463185|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
463186|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
463187|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg Dimebon (latrepirdine) tablet orally three times a day up to Week 12.
463188|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
463189|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
463190|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
465927|NCT00832455|O1|Outcome|Montelukast ITT at Week 4|
463191|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
463192|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
463193|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
463194|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
463195|NCT00838110|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
463196|NCT00838110|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
463197|NCT00838097|B1|Baseline|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463198|NCT00838097|P1|Participant Flow|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463199|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463200|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463201|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463202|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463203|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463204|NCT00838097|E1|Reported Event|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
463205|NCT00837967|B1|Baseline|All Study Participants|
463206|NCT00837967|P2|Participant Flow|Terbutaline First, Then Symbicort|Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
463207|NCT00837967|P1|Participant Flow|Symbicort First, Then Terbutaline|Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
463208|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
463209|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
463210|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
463211|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
463212|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
463213|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
463214|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
463215|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
463216|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
463217|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
463218|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
463219|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
463220|NCT00837967|E2|Reported Event|Terbutaline|Terbutaline Turbuhaler 0.4 mg for 3 days
463221|NCT00837967|E1|Reported Event|Symbicort|Symbicort Turbuhaler 160/4.5μg for 3 days
463222|NCT00837876|B1|Baseline|Treatment|Sorafenib + Erlotinib
463223|NCT00837876|P1|Participant Flow|Treatment|Sorafenib + Erlotinib
463224|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
463225|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
463226|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
463227|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
463228|NCT00837876|E1|Reported Event|Treatment|Sorafenib + Erlotinib
463229|NCT00837824|B3|Baseline|Total|Total of all reporting groups
463230|NCT00837824|B2|Baseline|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
463231|NCT00837824|B1|Baseline|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
463232|NCT00837824|P2|Participant Flow|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
463233|NCT00837824|P1|Participant Flow|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
463234|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
463235|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
463236|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
463237|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
463238|NCT00837824|E3|Reported Event|Total|
463239|NCT00837824|E2|Reported Event|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
463240|NCT00837824|E1|Reported Event|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
463241|NCT00837811|B4|Baseline|Total|Total of all reporting groups
463242|NCT00837811|B3|Baseline|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463243|NCT00837811|B2|Baseline|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463244|NCT00837811|B1|Baseline|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463245|NCT00837811|P3|Participant Flow|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463246|NCT00837811|P2|Participant Flow|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463247|NCT00837811|P1|Participant Flow|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463248|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463249|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463250|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463251|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463252|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463253|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463254|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463255|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463256|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463257|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463258|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463259|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463260|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463261|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463262|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463263|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463264|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463265|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463266|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463267|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463268|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
465928|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
463269|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463270|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463271|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463272|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463273|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463274|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463275|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463276|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463277|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463278|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463279|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463280|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463281|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463282|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463283|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463284|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463285|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463286|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463287|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463288|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463289|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463290|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463291|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463292|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463293|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463294|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
464377|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
463295|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463296|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463297|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463298|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463299|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463300|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463301|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463302|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463303|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463304|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463305|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463306|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463307|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463308|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463309|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463310|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463311|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463312|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463313|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463314|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463315|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463316|NCT00837811|O6|Outcome|60/120/60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
463317|NCT00837811|O5|Outcome|60/120 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
463318|NCT00837811|O4|Outcome|60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.~No study drug was administered during the post-study treatment follow-up."
463347|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463348|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463319|NCT00837811|O3|Outcome|60/120/60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total)."
463320|NCT00837811|O2|Outcome|60/120 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total)."
463321|NCT00837811|O1|Outcome|60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks."
463322|NCT00837811|O3|Outcome|60/120/60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total).
463323|NCT00837811|O2|Outcome|60/120 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total).
463324|NCT00837811|O1|Outcome|60 mg LY2127399|LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks.
463325|NCT00837811|E6|Reported Event|60/120/60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and a dose decrease back to 60 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
463326|NCT00837811|E5|Reported Event|60/120 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment.~No study drug was administered during the post-study treatment follow-up."
463327|NCT00837811|E4|Reported Event|60 mg LY2127399 Post-Study Treatment Follow-Up|"AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment.~No study drug was administered during the post-study treatment follow-up."
463328|NCT00837811|E3|Reported Event|60/120/60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total)."
463329|NCT00837811|E2|Reported Event|60/120 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total)."
463330|NCT00837811|E1|Reported Event|60 mg LY2127399 Treatment|"AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit).~LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks."
463331|NCT00837759|B1|Baseline|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463332|NCT00837759|P1|Participant Flow|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463333|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463334|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463335|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463336|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463337|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463338|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463339|NCT00837759|E1|Reported Event|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
463340|NCT00837616|B3|Baseline|Total|Total of all reporting groups
463341|NCT00837616|B2|Baseline|Group B|Group B received the transdermal estradiol for 12 months
463342|NCT00837616|B1|Baseline|Group A|Group A received the oral estradiol for 12 months
463343|NCT00837616|P2|Participant Flow|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463344|NCT00837616|P1|Participant Flow|Oral Estradiol|Group A received the oral estradiol for 12 months
463345|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463346|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
464378|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
463349|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463350|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463351|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463352|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463353|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463354|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463355|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463356|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463357|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463358|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463359|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463360|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463361|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463362|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463363|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
463364|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
463365|NCT00837616|E2|Reported Event|Group B|Group B received the transdermal estradiol for 12 months
463366|NCT00837616|E1|Reported Event|Group A|Group A received the oral estradiol for 12 months
463367|NCT00837577|B3|Baseline|Total|Total of all reporting groups
463368|NCT00837577|B2|Baseline|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
463369|NCT00837577|B1|Baseline|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
463370|NCT00837577|P2|Participant Flow|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
463371|NCT00837577|P1|Participant Flow|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
463372|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
463373|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
463374|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
463375|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
463376|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
463377|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
463378|NCT00837577|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
463379|NCT00837577|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
463380|NCT00837577|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
463381|NCT00837512|B1|Baseline|Entire Study Population|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
463382|NCT00837512|P2|Participant Flow|First: Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
463383|NCT00837512|P1|Participant Flow|First: Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
463384|NCT00837512|O2|Outcome|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
463385|NCT00837512|O1|Outcome|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
463386|NCT00837512|E2|Reported Event|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
463387|NCT00837512|E1|Reported Event|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
463388|NCT00837486|B3|Baseline|Total|Total of all reporting groups
463389|NCT00837486|B2|Baseline|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
463390|NCT00837486|B1|Baseline|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
463391|NCT00837486|P2|Participant Flow|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
463392|NCT00837486|P1|Participant Flow|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
463393|NCT00837486|O1|Outcome|All Enrolled Subjects|The 30 subjects were followed an average of 36 months after enrollment.
463394|NCT00837486|O1|Outcome|Long-term Open-label Treatment|All subjects received open-label active stimulation after the 16 week blinded-treatment phase.
463395|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
463396|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
463397|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
463398|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
463399|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
463400|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
463401|NCT00837486|E2|Reported Event|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
463402|NCT00837486|E1|Reported Event|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
463403|NCT00837473|B1|Baseline|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463404|NCT00837473|P1|Participant Flow|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463405|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463406|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463407|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463408|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463409|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463410|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463411|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463412|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463413|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463414|NCT00837473|O1|Outcome|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463415|NCT00837473|E1|Reported Event|Plexur-P Bone Void Filler|"Single arm. Open Label.~Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures"
463416|NCT00837447|B1|Baseline|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
463417|NCT00837447|P1|Participant Flow|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
463418|NCT00837447|O2|Outcome|High-Flexion Posterior Cruciate Scrificing TKA|
463419|NCT00837447|O1|Outcome|High-Flexion Posterior Cruciate Retaining TKA|
463420|NCT00837447|E1|Reported Event|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
463421|NCT00837434|B3|Baseline|Total|Total of all reporting groups
463422|NCT00837434|B2|Baseline|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463423|NCT00837434|B1|Baseline|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463424|NCT00837434|P2|Participant Flow|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463425|NCT00837434|P1|Participant Flow|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463426|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463427|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463428|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463429|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463430|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463431|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463432|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463433|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463434|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463435|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463436|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463437|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463438|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463439|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463440|NCT00837434|E2|Reported Event|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
463441|NCT00837434|E1|Reported Event|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
463442|NCT00837330|B3|Baseline|Total|Total of all reporting groups
463443|NCT00837330|B2|Baseline|Ranibizumab 0.3 mg/ 0.05 cc|Intraocular injection of 0.3 mg /0.05 cc ranibizumab
463444|NCT00837330|B1|Baseline|Ranibizumab 0.5 mg/ 0.05 cc|Intraocular injection of 0.5 mg /0.05 cc ranibizumab
463445|NCT00837330|P2|Participant Flow|Intraocular Injection 0.3 mg Ranibizumab|10 patients will receive intraocular injection 0.3 mg ranibizumab
463446|NCT00837330|P1|Participant Flow|Intraocular Injection 0.5 mg Ranibizumab|10 patients will receive intraocular injection 0.5 mg ranibizumab
463447|NCT00837330|O2|Outcome|Ranibizumab 0.3 mg|Intraocular injection 0.3 mg ranibizumab
463448|NCT00837330|O1|Outcome|Ranibizumab 0.5 mg|Intraocular injection of 0.5 mg ranibizumab
463449|NCT00837330|E2|Reported Event|Ranibizumab 0.3 mg|Intravitreal Injection of Ranibizumab 0.5 mg
463450|NCT00837330|E1|Reported Event|Ranibizumab 0.5 mg|Intravitreal Injection of Ranibizumab 0.5 mg
463451|NCT00837252|B1|Baseline|Finasteride|
463452|NCT00837252|P1|Participant Flow|Finasteride|All five study participants (all of whom were diagnosed with chronic CSC) were administered a 5mg oral dose of finasteride daily for three months. After three months, the finasteride was withheld and the participants were observed for another three months.
463453|NCT00837252|O1|Outcome|Finasteride|
463454|NCT00837252|O1|Outcome|Finasteride|
463455|NCT00837252|O1|Outcome|Finasteride|
463456|NCT00837252|O1|Outcome|Finasteride|
463457|NCT00837252|O1|Outcome|Finasteride|
463458|NCT00837252|O1|Outcome|Finasteride|
463459|NCT00837252|O1|Outcome|Finasteride|
463460|NCT00837252|O1|Outcome|Finasteride|
463461|NCT00837252|O1|Outcome|Finasteride|
463462|NCT00837252|O1|Outcome|Finasteride|
463463|NCT00837252|O1|Outcome|Finasteride|
463464|NCT00837252|O1|Outcome|Finasteride|
463465|NCT00837252|E1|Reported Event|Finasteride|
463466|NCT00837213|B3|Baseline|Total|Total of all reporting groups
463467|NCT00837213|B2|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463468|NCT00837213|B1|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463469|NCT00837213|P2|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463470|NCT00837213|P1|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463471|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463472|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463473|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463474|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463475|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463476|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463477|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463478|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463479|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463480|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463481|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
464379|NCT00835159|B3|Baseline|Total|Total of all reporting groups
463482|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463483|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463484|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463485|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463486|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463487|NCT00837213|E2|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
463488|NCT00837213|E1|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
463489|NCT00837200|B1|Baseline|Treatment|Oncaspar 2500 IU/m2 D1,15; Doxil 20mg/m2 D1,15; Decadron 20 mg D1,8,15,22
463490|NCT00837200|P1|Participant Flow|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
463491|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
463492|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
463493|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
463494|NCT00837200|E1|Reported Event|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
463495|NCT00837161|B1|Baseline|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
463496|NCT00837161|P1|Participant Flow|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
463497|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
463498|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
463499|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
463500|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
463501|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
463502|NCT00837161|E1|Reported Event|HIFU Treatment|
463503|NCT00837148|B1|Baseline|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
463504|NCT00837148|P1|Participant Flow|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
463505|NCT00837148|O1|Outcome|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
463506|NCT00837148|E1|Reported Event|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
464437|NCT00835042|B3|Baseline|Total|Total of all reporting groups
463507|NCT00837031|B1|Baseline|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
463508|NCT00837031|P1|Participant Flow|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
463509|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
463510|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
463511|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
463512|NCT00837031|E1|Reported Event|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
463513|NCT00836953|B1|Baseline|Study Group|Participants received study vaccine on Days 0 and 30.
463514|NCT00836953|P1|Participant Flow|Study Group|Participants received study vaccine on Days 0 and 30.
463515|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
463516|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
463517|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
463518|NCT00836953|E1|Reported Event|Study Group|Participants received study vaccine on Days 0 and 30.
463519|NCT00836927|B6|Baseline|Total|Total of all reporting groups
463520|NCT00836927|B5|Baseline|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463521|NCT00836927|B4|Baseline|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463522|NCT00836927|B3|Baseline|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463523|NCT00836927|B2|Baseline|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463524|NCT00836927|B1|Baseline|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463525|NCT00836927|P5|Participant Flow|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463526|NCT00836927|P4|Participant Flow|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463527|NCT00836927|P3|Participant Flow|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463528|NCT00836927|P2|Participant Flow|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463529|NCT00836927|P1|Participant Flow|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463530|NCT00836927|O5|Outcome|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463531|NCT00836927|O4|Outcome|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463532|NCT00836927|O3|Outcome|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463533|NCT00836927|O2|Outcome|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463534|NCT00836927|O1|Outcome|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463535|NCT00836927|O5|Outcome|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463536|NCT00836927|O4|Outcome|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463537|NCT00836927|O3|Outcome|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463538|NCT00836927|O2|Outcome|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463539|NCT00836927|O1|Outcome|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463540|NCT00836927|O5|Outcome|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463541|NCT00836927|O4|Outcome|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463542|NCT00836927|O3|Outcome|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463543|NCT00836927|O2|Outcome|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463544|NCT00836927|O1|Outcome|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463545|NCT00836927|O5|Outcome|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463546|NCT00836927|O4|Outcome|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463547|NCT00836927|O3|Outcome|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463548|NCT00836927|O2|Outcome|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463549|NCT00836927|O1|Outcome|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463550|NCT00836927|O5|Outcome|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463551|NCT00836927|O4|Outcome|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463552|NCT00836927|O3|Outcome|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463553|NCT00836927|O2|Outcome|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463554|NCT00836927|O1|Outcome|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463555|NCT00836927|E5|Reported Event|Ridaforolimus 40 mg Days 1-5|Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
463556|NCT00836927|E4|Reported Event|Ridaforolimus 30 mg Days 1-5|Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
463557|NCT00836927|E3|Reported Event|Ridaforolimus 20 mg Days 1-5|Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
463558|NCT00836927|E2|Reported Event|Ridaforolimus 10 mg Days 1-6|Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
463559|NCT00836927|E1|Reported Event|Ridaforolimus 10 mg Days 1-5|Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
463560|NCT00836901|B3|Baseline|Total|Total of all reporting groups
463561|NCT00836901|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
463562|NCT00836901|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
463563|NCT00836901|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
463564|NCT00836901|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
463565|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
463566|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
463567|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
463568|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
463569|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
463570|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
463571|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
463572|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
463573|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
463574|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
463575|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
463576|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
463577|NCT00836875|B3|Baseline|Total|Total of all reporting groups
463578|NCT00836875|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463579|NCT00836875|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463580|NCT00836875|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463621|NCT00836719|P1|Participant Flow|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
464480|NCT00834977|B3|Baseline|Total|Total of all reporting groups
463581|NCT00836875|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463582|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463583|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463584|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463585|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463586|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463587|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463588|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463589|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463590|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463591|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463592|NCT00836875|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
463593|NCT00836875|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
463594|NCT00836810|B3|Baseline|Total|Total of all reporting groups
463595|NCT00836810|B2|Baseline|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463596|NCT00836810|B1|Baseline|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463597|NCT00836810|P2|Participant Flow|Standard Prednisolone|"11 patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463598|NCT00836810|P1|Participant Flow|Timed Release Tablet Prednisone|"11 patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463599|NCT00836810|O2|Outcome|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463600|NCT00836810|O1|Outcome|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463601|NCT00836810|O2|Outcome|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463602|NCT00836810|O1|Outcome|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463603|NCT00836810|O2|Outcome|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463604|NCT00836810|O1|Outcome|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463605|NCT00836810|O2|Outcome|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463606|NCT00836810|O1|Outcome|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463607|NCT00836810|O2|Outcome|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463608|NCT00836810|O1|Outcome|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463609|NCT00836810|O2|Outcome|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463610|NCT00836810|O1|Outcome|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463611|NCT00836810|E2|Reported Event|Standard Prednisolone|"Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.~Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets."
463612|NCT00836810|E1|Reported Event|Timed Release Tablet Prednisone|"Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.~Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets."
463613|NCT00836745|B1|Baseline|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
463614|NCT00836745|P1|Participant Flow|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
463615|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
463616|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
463617|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
463618|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
463619|NCT00836745|E1|Reported Event|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
463620|NCT00836719|B1|Baseline|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
464792|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
463622|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
463623|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
463624|NCT00836719|E1|Reported Event|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
463625|NCT00836706|B3|Baseline|Total|Total of all reporting groups
463626|NCT00836706|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
463627|NCT00836706|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
463628|NCT00836706|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
463629|NCT00836706|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
463630|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
463631|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
463632|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
463633|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
463634|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
463635|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
463636|NCT00836693|B3|Baseline|Total|Total of all reporting groups
463637|NCT00836693|B2|Baseline|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463638|NCT00836693|B1|Baseline|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463639|NCT00836693|P2|Participant Flow|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463640|NCT00836693|P1|Participant Flow|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463641|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463642|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463643|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463644|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463645|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463646|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463647|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463648|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463649|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463650|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463651|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463652|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463653|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463654|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463655|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463656|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463657|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
464793|NCT00834483|B3|Baseline|Total|Total of all reporting groups
463658|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463659|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463660|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463661|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463662|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463663|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463664|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463665|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463666|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463667|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463668|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463669|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463670|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463671|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463672|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463673|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463674|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463675|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
463676|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463677|NCT00836693|E2|Reported Event|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
463678|NCT00836693|E1|Reported Event|Tadalafil|Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
463679|NCT00836641|B3|Baseline|Total|Total of all reporting groups
463680|NCT00836641|B2|Baseline|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
463681|NCT00836641|B1|Baseline|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
463682|NCT00836641|P2|Participant Flow|Group B: Sequential Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
463683|NCT00836641|P1|Participant Flow|Group A: Sequential Pneumococcal Immunzation (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
463684|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
463685|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
463686|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
463687|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
463688|NCT00836641|E1|Reported Event|Overall Study Population|the whole study population was observed for adverse events.
463689|NCT00836498|B3|Baseline|Total|Total of all reporting groups
463690|NCT00836498|B2|Baseline|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
465929|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
463691|NCT00836498|B1|Baseline|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463692|NCT00836498|P2|Participant Flow|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463693|NCT00836498|P1|Participant Flow|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463694|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463695|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463696|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463697|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463698|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463699|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463700|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463701|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463702|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463703|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463704|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463705|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463706|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463707|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463708|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463709|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463710|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463711|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463712|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463713|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463714|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463715|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463716|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463717|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463718|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463719|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463720|NCT00836498|E2|Reported Event|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
464794|NCT00834483|B2|Baseline|Control Group|Layered traditional wound closure (monocryl)
463721|NCT00836498|E1|Reported Event|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
463722|NCT00836472|B3|Baseline|Total|Total of all reporting groups
463723|NCT00836472|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
463724|NCT00836472|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
463725|NCT00836472|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
463726|NCT00836472|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
463727|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463728|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
463729|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463730|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
463731|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463732|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
463733|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463734|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
463735|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463736|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
463737|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463738|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
463739|NCT00836433|B3|Baseline|Total|Total of all reporting groups
463740|NCT00836433|B2|Baseline|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463741|NCT00836433|B1|Baseline|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463742|NCT00836433|P2|Participant Flow|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463743|NCT00836433|P1|Participant Flow|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463744|NCT00836433|O2|Outcome|CONNECT and FALLS|"CONNECT intervention on relationship-building and communication. Includes 2 in-class session, group mapping, individual relationship mapping, coaching sessions.~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463745|NCT00836433|O1|Outcome|FALLS Only|"Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463746|NCT00836433|O2|Outcome|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463747|NCT00836433|O1|Outcome|FALLS|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463748|NCT00836433|E2|Reported Event|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463749|NCT00836433|E1|Reported Event|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
463750|NCT00836407|B3|Baseline|Total|Total of all reporting groups
463751|NCT00836407|B2|Baseline|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
463752|NCT00836407|B1|Baseline|Arm 1: Ipilimumab Alone|Ipilimumab alone
463753|NCT00836407|P2|Participant Flow|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
463754|NCT00836407|P1|Participant Flow|Arm 1: Ipilimumab Alone|Ipilimumab alone
463755|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
463756|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
463757|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
463758|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
463759|NCT00836407|E2|Reported Event|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
463760|NCT00836407|E1|Reported Event|Arm 1: Ipilimumab Alone|Ipilimumab alone
463761|NCT00836355|B5|Baseline|Total|Total of all reporting groups
463762|NCT00836355|B4|Baseline|Control|
463763|NCT00836355|B3|Baseline|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
463764|NCT00836355|B2|Baseline|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
463765|NCT00836355|B1|Baseline|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
463766|NCT00836355|P4|Participant Flow|Control|
463767|NCT00836355|P3|Participant Flow|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
463768|NCT00836355|P2|Participant Flow|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
463769|NCT00836355|P1|Participant Flow|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
463770|NCT00836355|O4|Outcome|Control|
463771|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
463772|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
463773|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
463774|NCT00836355|O4|Outcome|Control|
463775|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
463776|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
463777|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
463778|NCT00836355|O4|Outcome|Control|
463779|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
463780|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
463781|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
463782|NCT00836355|E4|Reported Event|Control|
463783|NCT00836355|E3|Reported Event|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
463784|NCT00836355|E2|Reported Event|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
463785|NCT00836355|E1|Reported Event|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
463786|NCT00836342|B4|Baseline|Total|Total of all reporting groups
463787|NCT00836342|B3|Baseline|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
463788|NCT00836342|B2|Baseline|Previous History of BCC|Participants had previous history of basal cell carcinoma
463789|NCT00836342|B1|Baseline|Previous History of SCC|Participants had previous history of squamous cell carcinoma
463790|NCT00836342|P3|Participant Flow|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
463791|NCT00836342|P2|Participant Flow|Previous History of BCC|Participants had previous history of basal cell carcinoma
463792|NCT00836342|P1|Participant Flow|Previous History of SCC|Participants had previous history of squamous cell carcinoma
463793|NCT00836342|O2|Outcome|Control Group|Participants had no history of previous squamous cell carcinoma or basal cell carcinoma
463794|NCT00836342|O1|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
463795|NCT00836342|O2|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
463796|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
463797|NCT00836342|O2|Outcome|Control Group|Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
463798|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
463799|NCT00836342|E3|Reported Event|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
463800|NCT00836342|E2|Reported Event|Previous History of BCC|Participants had previous history of basal cell carcinoma
463801|NCT00836342|E1|Reported Event|Previous History of SCC|Participants had previous history of squamous cell carcinoma
463802|NCT00836277|B1|Baseline|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
463803|NCT00836277|P1|Participant Flow|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
463804|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
463805|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
464156|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
463806|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
463807|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
463808|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
463809|NCT00836277|E1|Reported Event|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
463810|NCT00836095|B3|Baseline|Total|Total of all reporting groups
463811|NCT00836095|B2|Baseline|Proseal LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
463812|NCT00836095|B1|Baseline|Supreme LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant."
463813|NCT00836095|P2|Participant Flow|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
463814|NCT00836095|P1|Participant Flow|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
463815|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
463816|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
463817|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
463818|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
463819|NCT00836095|E2|Reported Event|Proseal LMA|"Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
463820|NCT00836095|E1|Reported Event|Supreme LMA|"Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant"
463821|NCT00836056|B3|Baseline|Total|Total of all reporting groups
463822|NCT00836056|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
463823|NCT00836056|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
463824|NCT00836056|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
463825|NCT00836056|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
463826|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
463827|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
463828|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
463829|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
463830|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
463831|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
463832|NCT00836017|B1|Baseline|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463833|NCT00836017|P1|Participant Flow|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463834|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463835|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463836|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463837|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463838|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463839|NCT00836017|E1|Reported Event|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
463840|NCT00836004|B3|Baseline|Total|Total of all reporting groups
463841|NCT00836004|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
463842|NCT00836004|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
463843|NCT00836004|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
463844|NCT00836004|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
463845|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
463846|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
463847|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
463848|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
463849|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
463850|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
463851|NCT00835991|B3|Baseline|Total|Total of all reporting groups
463852|NCT00835991|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
463853|NCT00835991|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
463854|NCT00835991|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
463855|NCT00835991|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
463856|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463857|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
463858|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463859|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
463860|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463861|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
463862|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463863|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
463864|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463865|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
463866|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
463867|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
463868|NCT00835978|B5|Baseline|Total|Total of all reporting groups
463869|NCT00835978|B4|Baseline|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
463870|NCT00835978|B3|Baseline|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463871|NCT00835978|B2|Baseline|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463872|NCT00835978|B1|Baseline|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463873|NCT00835978|P4|Participant Flow|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
463874|NCT00835978|P3|Participant Flow|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463922|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463875|NCT00835978|P2|Participant Flow|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463876|NCT00835978|P1|Participant Flow|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463877|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463878|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463879|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463880|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463881|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463882|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463883|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463884|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
463885|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463886|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463887|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463888|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463889|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463890|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463955|NCT00835900|O2|Outcome|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
463956|NCT00835900|O1|Outcome|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
463891|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463892|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463893|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463894|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463895|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463896|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463897|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463898|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463899|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463900|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463901|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
463902|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463903|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463904|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463905|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
463957|NCT00835900|E2|Reported Event|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
463958|NCT00835900|E1|Reported Event|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
463906|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463907|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463908|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463909|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463910|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463911|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463912|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463913|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463914|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463915|NCT00835978|O3|Outcome|Non-randomized Arm (SA Population)|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463916|NCT00835978|O2|Outcome|Placebo Titration Arm (FA Population)|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463917|NCT00835978|O1|Outcome|Active Titration Arm (FA Population)|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463918|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463919|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463920|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463921|NCT00835978|O4|Outcome|All Participants|All enrolled participants (randomized and non-randomized)
463923|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463924|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463925|NCT00835978|O4|Outcome|All Participants|All enrolled participants (randomized and non-randomized)
463926|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463927|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463928|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463929|NCT00835978|E4|Reported Event|Discontinued Prior to Randomization|Participants who were discontinued prior to randomization to either treatment or non-randomization arms.
463930|NCT00835978|E3|Reported Event|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
463931|NCT00835978|E2|Reported Event|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
463932|NCT00835978|E1|Reported Event|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
463933|NCT00835926|B3|Baseline|Total|Total of all reporting groups
463934|NCT00835926|B2|Baseline|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
463935|NCT00835926|B1|Baseline|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
463936|NCT00835926|P2|Participant Flow|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
463937|NCT00835926|P1|Participant Flow|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
463938|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
463939|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
463940|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
463941|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
463942|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
463943|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
463944|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
463945|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
463946|NCT00835926|E2|Reported Event|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
463947|NCT00835926|E1|Reported Event|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
463948|NCT00835900|B3|Baseline|Total|Total of all reporting groups
463949|NCT00835900|B2|Baseline|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
463950|NCT00835900|B1|Baseline|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
463951|NCT00835900|P2|Participant Flow|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
463952|NCT00835900|P1|Participant Flow|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
463953|NCT00835900|O2|Outcome|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
463954|NCT00835900|O1|Outcome|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
463960|NCT00835861|B2|Baseline|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
463961|NCT00835861|B1|Baseline|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone.
463962|NCT00835861|P2|Participant Flow|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and neutral protamine Hagedorn (NPH) insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
463963|NCT00835861|P1|Participant Flow|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone
463964|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463965|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463966|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463967|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463968|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463969|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463970|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463971|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463972|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463973|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463974|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463975|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463976|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463977|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463978|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463979|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463980|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463981|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463982|NCT00835861|E2|Reported Event|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
463983|NCT00835861|E1|Reported Event|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
463984|NCT00835796|B3|Baseline|Total|Total of all reporting groups
463985|NCT00835796|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
463986|NCT00835796|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
463987|NCT00835796|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
463988|NCT00835796|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
463989|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
463990|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
463991|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
463992|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
463993|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
463994|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
463995|NCT00835731|B3|Baseline|Total|Total of all reporting groups
463996|NCT00835731|B2|Baseline|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
463997|NCT00835731|B1|Baseline|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464034|NCT00835692|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
463998|NCT00835731|P2|Participant Flow|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
463999|NCT00835731|P1|Participant Flow|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464000|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464001|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464002|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464003|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464004|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464005|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464006|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464007|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464008|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464009|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464010|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464011|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464012|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464013|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464014|NCT00835731|E2|Reported Event|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
464015|NCT00835731|E1|Reported Event|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
464016|NCT00835705|B3|Baseline|Total|Total of all reporting groups
464017|NCT00835705|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
464018|NCT00835705|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
464019|NCT00835705|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
464020|NCT00835705|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
464021|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
464022|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
464023|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
464024|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
464025|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
464026|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
464027|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
464028|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
464029|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
464030|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
464031|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
464032|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
464033|NCT00835692|B3|Baseline|Total|Total of all reporting groups
464155|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
464035|NCT00835692|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
464036|NCT00835692|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
464037|NCT00835692|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
464038|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
464039|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
464040|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
464041|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
464042|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
464043|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
464044|NCT00835679|B5|Baseline|Total|Total of all reporting groups
464045|NCT00835679|B4|Baseline|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
464046|NCT00835679|B3|Baseline|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
464047|NCT00835679|B2|Baseline|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
464048|NCT00835679|B1|Baseline|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
464049|NCT00835679|P4|Participant Flow|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
464050|NCT00835679|P3|Participant Flow|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
464051|NCT00835679|P2|Participant Flow|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
464052|NCT00835679|P1|Participant Flow|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
464053|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
464054|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
464055|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
464056|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
464057|NCT00835679|O4|Outcome|Cetuximab + Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
464058|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15 1-14.
464059|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
464060|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
464061|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
464062|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
464063|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
464064|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
464065|NCT00835679|O4|Outcome|Cetuximab +Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
464066|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
464067|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
464068|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
464069|NCT00835679|E4|Reported Event|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
464070|NCT00835679|E3|Reported Event|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
464071|NCT00835679|E2|Reported Event|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
464072|NCT00835679|E1|Reported Event|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
464073|NCT00835666|B3|Baseline|Total|Total of all reporting groups
464074|NCT00835666|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
464075|NCT00835666|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
464076|NCT00835666|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
464077|NCT00835666|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
464078|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
464079|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
464080|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
464081|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
464082|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
464083|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
464084|NCT00835640|B3|Baseline|Total|Total of all reporting groups
464085|NCT00835640|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
464086|NCT00835640|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
464087|NCT00835640|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
464088|NCT00835640|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
464089|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
464090|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
464091|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
464092|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
464093|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
464094|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
464095|NCT00835614|B3|Baseline|Total|Total of all reporting groups
464096|NCT00835614|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
464097|NCT00835614|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
464098|NCT00835614|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
464099|NCT00835614|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
464100|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
464101|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
464102|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
464103|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
464104|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
464105|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
464106|NCT00835588|B3|Baseline|Total|Total of all reporting groups
464107|NCT00835588|B2|Baseline|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
464108|NCT00835588|B1|Baseline|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
464109|NCT00835588|P2|Participant Flow|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
464110|NCT00835588|P1|Participant Flow|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
464111|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
464112|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
464113|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
464114|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
464115|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
464116|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
464117|NCT00835575|B3|Baseline|Total|Total of all reporting groups
464118|NCT00835575|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
464119|NCT00835575|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
464120|NCT00835575|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
464121|NCT00835575|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
464122|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
464123|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
464124|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
464125|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
464126|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
464127|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
464128|NCT00835549|B3|Baseline|Total|Total of all reporting groups
464129|NCT00835549|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
464130|NCT00835549|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
464131|NCT00835549|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
464132|NCT00835549|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
464133|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
464134|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
464135|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
464136|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
464137|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
464138|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
464139|NCT00835536|B3|Baseline|Total|Total of all reporting groups
464140|NCT00835536|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
464141|NCT00835536|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
464142|NCT00835536|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
464143|NCT00835536|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
464144|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
464145|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
464146|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
464147|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
464148|NCT00835510|B4|Baseline|Total|Total of all reporting groups
464149|NCT00835510|B3|Baseline|Vehicle|Butenafine vehicle applied for 7 days
464150|NCT00835510|B2|Baseline|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
464151|NCT00835510|B1|Baseline|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464152|NCT00835510|P3|Participant Flow|Vehicle|Butenafine vehicle applied for 7 days
464153|NCT00835510|P2|Participant Flow|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
464154|NCT00835510|P1|Participant Flow|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464157|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464158|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
464159|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
464160|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464161|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
464162|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
464163|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464164|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
464165|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
464166|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464167|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
464168|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
464169|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464170|NCT00835510|E3|Reported Event|Vehicle|Butenafine vehicle applied for 7 days
464171|NCT00835510|E2|Reported Event|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
464172|NCT00835510|E1|Reported Event|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
464173|NCT00835497|B3|Baseline|Total|Total of all reporting groups
464174|NCT00835497|B2|Baseline|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
464175|NCT00835497|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
464176|NCT00835497|P2|Participant Flow|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
464177|NCT00835497|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
464178|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
464179|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464180|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
464181|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464182|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
464183|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464184|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
464185|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464186|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
464187|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464188|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
464189|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464190|NCT00835484|B3|Baseline|Total|Total of all reporting groups
464191|NCT00835484|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
464192|NCT00835484|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
464193|NCT00835484|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
464194|NCT00835484|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
464195|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
464196|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
464197|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
464198|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
464199|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
464200|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
464201|NCT00835406|B3|Baseline|Total|Total of all reporting groups
464202|NCT00835406|B2|Baseline|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
464203|NCT00835406|B1|Baseline|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
464204|NCT00835406|P2|Participant Flow|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
464205|NCT00835406|P1|Participant Flow|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
464206|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
464207|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
464209|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
464210|NCT00835380|B1|Baseline|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
464211|NCT00835380|P1|Participant Flow|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
464212|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
464213|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
464214|NCT00835380|E1|Reported Event|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
464215|NCT00835367|B3|Baseline|Total|Total of all reporting groups
464216|NCT00835367|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
464217|NCT00835367|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
464218|NCT00835367|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
464219|NCT00835367|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
464220|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464221|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464222|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464223|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464224|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464225|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464226|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464227|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464228|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464229|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464230|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464231|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464232|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464233|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464234|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464235|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464236|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464237|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
464238|NCT00835354|B3|Baseline|Total|Total of all reporting groups
464239|NCT00835354|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
464240|NCT00835354|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
464241|NCT00835354|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
464242|NCT00835354|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
464243|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
464244|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
464245|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
464246|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
464247|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
464248|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
464249|NCT00835341|B3|Baseline|Total|Total of all reporting groups
464250|NCT00835341|B2|Baseline|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
464251|NCT00835341|B1|Baseline|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
464252|NCT00835341|P2|Participant Flow|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
464253|NCT00835341|P1|Participant Flow|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
464254|NCT00835341|O2|Outcome|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
464255|NCT00835341|O1|Outcome|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
464256|NCT00835341|E2|Reported Event|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
465930|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
464257|NCT00835341|E1|Reported Event|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
464258|NCT00835276|B3|Baseline|Total|Total of all reporting groups
464259|NCT00835276|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
464260|NCT00835276|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
464261|NCT00835276|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
464262|NCT00835276|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
464263|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
464264|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
464265|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
464266|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
464267|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
464268|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
464269|NCT00835263|B3|Baseline|Total|Total of all reporting groups
464270|NCT00835263|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
464271|NCT00835263|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
464272|NCT00835263|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
464273|NCT00835263|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
464274|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
464275|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
464276|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
464277|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
464278|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
464279|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
464280|NCT00835237|B3|Baseline|Total|Total of all reporting groups
464281|NCT00835237|B2|Baseline|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464282|NCT00835237|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464283|NCT00835237|P2|Participant Flow|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464284|NCT00835237|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464285|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464286|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464287|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464288|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464289|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464290|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464291|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464292|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464293|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464294|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464295|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464296|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464297|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464298|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464299|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464300|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464301|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464302|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464303|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac (tetanus and diphtheria toxoids vaccine)
464795|NCT00834483|B1|Baseline|Treatment Group|Knotless suture for wound closure
464304|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464305|NCT00835237|E2|Reported Event|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
464306|NCT00835237|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
464307|NCT00835224|B1|Baseline|All Participants|All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order.
464308|NCT00835224|P1|Participant Flow|All Participants|All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits.
464309|NCT00835224|O6|Outcome|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
464310|NCT00835224|O5|Outcome|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
464311|NCT00835224|O4|Outcome|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
464312|NCT00835224|O3|Outcome|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
464313|NCT00835224|O2|Outcome|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
464314|NCT00835224|O1|Outcome|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
464315|NCT00835224|E6|Reported Event|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
464316|NCT00835224|E5|Reported Event|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
464317|NCT00835224|E4|Reported Event|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
464318|NCT00835224|E3|Reported Event|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
464319|NCT00835224|E2|Reported Event|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
464320|NCT00835224|E1|Reported Event|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
464321|NCT00835211|B3|Baseline|Total|Total of all reporting groups
464322|NCT00835211|B2|Baseline|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
464323|NCT00835211|B1|Baseline|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
464324|NCT00835211|P2|Participant Flow|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
464325|NCT00835211|P1|Participant Flow|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
464326|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
464327|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
464328|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
464329|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
464330|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
464331|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
464332|NCT00835198|B3|Baseline|Total|Total of all reporting groups
464333|NCT00835198|B2|Baseline|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
464334|NCT00835198|B1|Baseline|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
464335|NCT00835198|P2|Participant Flow|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
464336|NCT00835198|P1|Participant Flow|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
464337|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
464338|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
464339|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
464340|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
464341|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
464342|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
464343|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
464344|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
464345|NCT00835198|E2|Reported Event|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
464346|NCT00835198|E1|Reported Event|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
464347|NCT00835185|B1|Baseline|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464371|NCT00835172|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
464348|NCT00835185|P1|Participant Flow|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes~85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met."
464349|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464350|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464351|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464352|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464353|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464354|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464355|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464356|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
464357|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
464372|NCT00835172|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
464373|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
464374|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
464375|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
464358|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
464359|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
464360|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
464361|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464362|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464363|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464364|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464365|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464366|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464367|NCT00835185|E1|Reported Event|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
464368|NCT00835172|B3|Baseline|Total|Total of all reporting groups
464369|NCT00835172|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
464370|NCT00835172|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
464376|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
464380|NCT00835159|B2|Baseline|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
464381|NCT00835159|B1|Baseline|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
464382|NCT00835159|P2|Participant Flow|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
464383|NCT00835159|P1|Participant Flow|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
464384|NCT00835159|O2|Outcome|Placebo Patch|Eligible patients received a placebo patch
464385|NCT00835159|O1|Outcome|Rivastigmine Patch|Eligible patients received a rivastigmine 5-cm2 transdermal patch
464386|NCT00835159|E2|Reported Event|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
464387|NCT00835159|E1|Reported Event|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
464388|NCT00835146|B3|Baseline|Total|Total of all reporting groups
464389|NCT00835146|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
464390|NCT00835146|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
464391|NCT00835146|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
464392|NCT00835146|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
464393|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
464394|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
464395|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
464396|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
464397|NCT00835120|B1|Baseline|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464398|NCT00835120|P1|Participant Flow|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464399|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464400|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464401|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464402|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464403|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464404|NCT00835120|E1|Reported Event|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
464405|NCT00835081|B3|Baseline|Total|Total of all reporting groups
464406|NCT00835081|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
464407|NCT00835081|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
464408|NCT00835081|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
464409|NCT00835081|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
464410|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
464411|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
464412|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
464413|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
464414|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
464415|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
464416|NCT00835068|B3|Baseline|Total|Total of all reporting groups
464417|NCT00835068|B2|Baseline|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
464418|NCT00835068|B1|Baseline|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464419|NCT00835068|P2|Participant Flow|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
464420|NCT00835068|P1|Participant Flow|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464421|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464422|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464423|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464424|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464425|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
464426|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464427|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464428|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464429|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
464430|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464431|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
464432|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464433|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
464434|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464435|NCT00835068|E2|Reported Event|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
464436|NCT00835068|E1|Reported Event|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
464438|NCT00835042|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
464439|NCT00835042|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
464440|NCT00835042|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
464441|NCT00835042|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
464442|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464443|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464444|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464445|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464446|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464447|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464448|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464449|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464450|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464451|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464452|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464453|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464454|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464455|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464456|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464457|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464458|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
464459|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
464460|NCT00835003|B3|Baseline|Total|Total of all reporting groups
464461|NCT00835003|B2|Baseline|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
464462|NCT00835003|B1|Baseline|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
464463|NCT00835003|P2|Participant Flow|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
464464|NCT00835003|P1|Participant Flow|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
464465|NCT00835003|O2|Outcome|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
464466|NCT00835003|O1|Outcome|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
464467|NCT00835003|E2|Reported Event|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
464468|NCT00835003|E1|Reported Event|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
464469|NCT00834990|B3|Baseline|Total|Total of all reporting groups
464470|NCT00834990|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
464471|NCT00834990|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
464472|NCT00834990|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
464473|NCT00834990|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
464474|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
464475|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
464476|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
464477|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
464478|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
464479|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
464481|NCT00834977|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
464482|NCT00834977|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
464483|NCT00834977|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
464484|NCT00834977|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
464485|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464486|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464487|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464488|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464489|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464490|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464491|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464492|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464493|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464494|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464495|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464496|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464497|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464498|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464499|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464500|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464501|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
464502|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
464503|NCT00834964|B3|Baseline|Total|Total of all reporting groups
464504|NCT00834964|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
464505|NCT00834964|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
464506|NCT00834964|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
464507|NCT00834964|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
464508|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464509|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464510|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464511|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464512|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464513|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464514|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464515|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464516|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464517|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464518|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464519|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464520|NCT00834912|B7|Baseline|Total|Total of all reporting groups
464521|NCT00834912|B6|Baseline|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
464522|NCT00834912|B5|Baseline|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
464523|NCT00834912|B4|Baseline|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
464580|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464581|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
465931|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
464524|NCT00834912|B3|Baseline|Confab Fed / Confab Fasting / Trillium Fasting|Confab fed / Confab fasting / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
464525|NCT00834912|B2|Baseline|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
464526|NCT00834912|B1|Baseline|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
464527|NCT00834912|P6|Participant Flow|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
464528|NCT00834912|P5|Participant Flow|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
464529|NCT00834912|P4|Participant Flow|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
464530|NCT00834912|P3|Participant Flow|Confab Fed / Confab Fasting / Trillium Fasting|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
464531|NCT00834912|P2|Participant Flow|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
464532|NCT00834912|P1|Participant Flow|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
464533|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
464534|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
464535|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
464536|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
464582|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464537|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
464538|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
464539|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
464540|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
464541|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
464542|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
464543|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
464544|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
464545|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
464546|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
464547|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
464583|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
464584|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
465932|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
464548|NCT00834912|E3|Reported Event|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
464549|NCT00834912|E2|Reported Event|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
464550|NCT00834912|E1|Reported Event|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
464551|NCT00834899|B3|Baseline|Total|Total of all reporting groups
464552|NCT00834899|B2|Baseline|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
464553|NCT00834899|B1|Baseline|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
464554|NCT00834899|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
464555|NCT00834899|P1|Participant Flow|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
464556|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
464557|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
464558|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
464559|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
464560|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
464561|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
464562|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
464563|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
464564|NCT00834899|E2|Reported Event|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
464565|NCT00834899|E1|Reported Event|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
464566|NCT00834886|B5|Baseline|Total|Total of all reporting groups
464567|NCT00834886|B4|Baseline|Placebo Melatonin and Placebo Light|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
464568|NCT00834886|B3|Baseline|Placebo Melatonin and Light Therapy|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464569|NCT00834886|B2|Baseline|Melatonin and Placebo Light|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
464570|NCT00834886|B1|Baseline|Melatonin and Light Therapy|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464571|NCT00834886|P4|Participant Flow|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
464572|NCT00834886|P3|Participant Flow|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464573|NCT00834886|P2|Participant Flow|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
464574|NCT00834886|P1|Participant Flow|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464575|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
464576|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464577|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
464578|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464579|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
464585|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
464586|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464587|NCT00834886|E4|Reported Event|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
464588|NCT00834886|E3|Reported Event|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464589|NCT00834886|E2|Reported Event|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
464590|NCT00834886|E1|Reported Event|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
464591|NCT00834873|B3|Baseline|Total|Total of all reporting groups
464592|NCT00834873|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
464593|NCT00834873|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
464594|NCT00834873|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
464595|NCT00834873|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
464596|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
464597|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
464598|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
464599|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
464600|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
464601|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
464602|NCT00834834|B3|Baseline|Total|Total of all reporting groups
464603|NCT00834834|B2|Baseline|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
464604|NCT00834834|B1|Baseline|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
464605|NCT00834834|P2|Participant Flow|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
464606|NCT00834834|P1|Participant Flow|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
464607|NCT00834834|O2|Outcome|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
464608|NCT00834834|O1|Outcome|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
464609|NCT00834834|O2|Outcome|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
464610|NCT00834834|O1|Outcome|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
464611|NCT00834834|E2|Reported Event|Dialectical Behavior Therapy|"Participants will receive dialectical behavioral therapy (DBT).~DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months."
464612|NCT00834834|E1|Reported Event|Fluoxetine|"Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI.~Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months.~Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months."
464613|NCT00834808|B4|Baseline|Total|Total of all reporting groups
464614|NCT00834808|B3|Baseline|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464615|NCT00834808|B2|Baseline|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464616|NCT00834808|B1|Baseline|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464617|NCT00834808|P3|Participant Flow|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464618|NCT00834808|P2|Participant Flow|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464619|NCT00834808|P1|Participant Flow|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464620|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464621|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
465933|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
464622|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464623|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464624|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464625|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464626|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464627|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464628|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464629|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464630|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464631|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464632|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464633|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464634|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464635|NCT00834808|E3|Reported Event|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464636|NCT00834808|E2|Reported Event|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464637|NCT00834808|E1|Reported Event|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
464638|NCT00834795|B3|Baseline|Total|Total of all reporting groups
464639|NCT00834795|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
464640|NCT00834795|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
464641|NCT00834795|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
464642|NCT00834795|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
464643|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
464644|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
464645|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
464646|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
464647|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
464648|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
464649|NCT00834756|B3|Baseline|Total|Total of all reporting groups
464650|NCT00834756|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
464651|NCT00834756|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
464652|NCT00834756|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
464653|NCT00834756|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
464654|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
464655|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
464656|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
464657|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
464658|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
464659|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
464660|NCT00834743|B3|Baseline|Total|Total of all reporting groups
464661|NCT00834743|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
464662|NCT00834743|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
464663|NCT00834743|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
464664|NCT00834743|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
464665|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
464666|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
464667|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
464668|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
464669|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
464670|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
464671|NCT00834717|B3|Baseline|Total|Total of all reporting groups
464672|NCT00834717|B2|Baseline|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
464673|NCT00834717|B1|Baseline|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
464674|NCT00834717|P2|Participant Flow|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
464675|NCT00834717|P1|Participant Flow|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
464676|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
464677|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
464678|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
464679|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
464680|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
464681|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
464682|NCT00834678|B1|Baseline|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464683|NCT00834678|P1|Participant Flow|Bendamustine and Erlotinib|Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 – 21 of each 28 day cycle.
464684|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464685|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464686|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464687|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 – 21 of each 28 day cycle.
464688|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464689|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464690|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464691|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.~Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
464692|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.~Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
464693|NCT00834678|E1|Reported Event|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
464694|NCT00834652|B3|Baseline|Total|Total of all reporting groups
464695|NCT00834652|B2|Baseline|Sertraline Plus Placebo|"Participants will receive sertraline and placebo for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day"
464696|NCT00834652|B1|Baseline|Sertraline Plus Metformin|"Participants will receive sertraline and metformin for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day~Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily"
464697|NCT00834652|P2|Participant Flow|Sertraline Plus Placebo|"Participants will receive sertraline and placebo for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day"
464698|NCT00834652|P1|Participant Flow|Sertraline Plus Metformin|"Participants will receive sertraline and metformin for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day~Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily"
464699|NCT00834652|O2|Outcome|Sertraline Plus Placebo|"Participants will receive sertraline and placebo for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day"
464742|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464700|NCT00834652|O1|Outcome|Sertraline Plus Metformin|"Participants will receive sertraline and metformin for 16 weeks.~Sertraline: 50 mg once a day, which may be increased to 200 mg once a day~Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily"
464701|NCT00834652|E2|Reported Event|Sertraline Plus Placebo|
464702|NCT00834652|E1|Reported Event|Sertraline Plus Metformin|
464703|NCT00834639|B3|Baseline|Total|Total of all reporting groups
464704|NCT00834639|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
464705|NCT00834639|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
464706|NCT00834639|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
464707|NCT00834639|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
464708|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
464709|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
464710|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
464711|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
464712|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
464713|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
464714|NCT00834626|B1|Baseline|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
464715|NCT00834626|P1|Participant Flow|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
464716|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
464717|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
464718|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
464719|NCT00834626|O1|Outcome|Percentage of Participants Not Requiring Insulin|Percentage of participants not requiring Insulin assessed at 1 year post-surgery
464720|NCT00834626|E1|Reported Event|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
464721|NCT00834613|B3|Baseline|Total|Total of all reporting groups
464722|NCT00834613|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
464723|NCT00834613|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
464724|NCT00834613|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
464725|NCT00834613|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
464726|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
464727|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
464728|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
464729|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
464730|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
464731|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
464732|NCT00834587|B3|Baseline|Total|Total of all reporting groups
464733|NCT00834587|B2|Baseline|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
464734|NCT00834587|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
464735|NCT00834587|P2|Participant Flow|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
464736|NCT00834587|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
464737|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
464738|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464739|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
464740|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464741|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
464743|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
464744|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464745|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
464746|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464747|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
464748|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
464749|NCT00834574|B3|Baseline|Total|Total of all reporting groups
464750|NCT00834574|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
464751|NCT00834574|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
464752|NCT00834574|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
464753|NCT00834574|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
464754|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
464755|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
464756|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
464757|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
464758|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
464759|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
464760|NCT00834561|B3|Baseline|Total|Total of all reporting groups
464761|NCT00834561|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
464762|NCT00834561|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
464763|NCT00834561|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
464764|NCT00834561|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
464765|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
464766|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
464767|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
464768|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
464769|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
464770|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
464771|NCT00834535|B3|Baseline|Total|Total of all reporting groups
464772|NCT00834535|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
464773|NCT00834535|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
464774|NCT00834535|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
464775|NCT00834535|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
464776|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
464777|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
464778|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
464779|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
464780|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
464781|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
464782|NCT00834522|B3|Baseline|Total|Total of all reporting groups
464783|NCT00834522|B2|Baseline|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
464784|NCT00834522|B1|Baseline|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
464785|NCT00834522|P2|Participant Flow|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
464786|NCT00834522|P1|Participant Flow|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
464787|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
464788|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
464789|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
464790|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
464791|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
465934|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
464796|NCT00834483|P2|Participant Flow|Control Group|Layered traditional wound closure (monocryl)
464797|NCT00834483|P1|Participant Flow|Treatment Group|Knotless suture for wound closure
464798|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
464799|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
464800|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
464801|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
464802|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
464803|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
464804|NCT00834483|E2|Reported Event|Control Group|Layered traditional wound closure (monocryl)
464805|NCT00834483|E1|Reported Event|Treatment Group|Knotless suture for wound closure
464806|NCT00834444|B3|Baseline|Total|Total of all reporting groups
464807|NCT00834444|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
464808|NCT00834444|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
464809|NCT00834444|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
464810|NCT00834444|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
464811|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
464812|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
464813|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
464814|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
464815|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
464816|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
464817|NCT00834431|B3|Baseline|Total|Total of all reporting groups
464818|NCT00834431|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
464819|NCT00834431|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
464820|NCT00834431|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
464821|NCT00834431|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
464822|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
464823|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
464824|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
464825|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
464826|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
464827|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
464828|NCT00834418|B3|Baseline|Total|Total of all reporting groups
464829|NCT00834418|B2|Baseline|Arava™|Arava™ 20 mg Tablet
464830|NCT00834418|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
464831|NCT00834418|P2|Participant Flow|Arava™|Arava™ 20 mg Tablet
464832|NCT00834418|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
464833|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
464834|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
464835|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
464836|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
464837|NCT00834405|B3|Baseline|Total|Total of all reporting groups
464838|NCT00834405|B2|Baseline|Arava®|Arava® 20 mg Tablet
464839|NCT00834405|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
464840|NCT00834405|P2|Participant Flow|Arava®|Arava® 20 mg Tablet
464841|NCT00834405|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
464842|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
464843|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
464844|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
464845|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
464846|NCT00834366|B3|Baseline|Total|Total of all reporting groups
464847|NCT00834366|B2|Baseline|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464848|NCT00834366|B1|Baseline|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464849|NCT00834366|P2|Participant Flow|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464850|NCT00834366|P1|Participant Flow|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464851|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464852|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464914|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464853|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464854|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464855|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464856|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464857|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464858|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464859|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464860|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464861|NCT00834366|E2|Reported Event|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
464862|NCT00834366|E1|Reported Event|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
464863|NCT00834340|B3|Baseline|Total|Total of all reporting groups
464864|NCT00834340|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
464865|NCT00834340|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
464866|NCT00834340|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
464867|NCT00834340|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
464868|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
464869|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
464870|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
464871|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
464872|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
464873|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
464874|NCT00834288|B3|Baseline|Total|Total of all reporting groups
464875|NCT00834288|B2|Baseline|Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First|1 x 50 mg Tramadol HCl IR (Ultram®) Tablet 6-Hourly reference product dosed in first period followed by Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II). IR = Immediate Release.
464876|NCT00834288|B1|Baseline|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
464877|NCT00834288|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 x 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
464878|NCT00834288|P1|Participant Flow|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
464879|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464880|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464881|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464882|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464912|NCT00834249|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
464883|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464884|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464885|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464886|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464887|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464888|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464889|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464890|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464891|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464892|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464893|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464894|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464895|NCT00834288|E2|Reported Event|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
464896|NCT00834288|E1|Reported Event|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
464897|NCT00834275|B3|Baseline|Total|Total of all reporting groups
464898|NCT00834275|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
464899|NCT00834275|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
464900|NCT00834275|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
464901|NCT00834275|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
464902|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
464903|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
464904|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
464905|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
464906|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
464907|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
464908|NCT00834249|B3|Baseline|Total|Total of all reporting groups
464909|NCT00834249|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
464910|NCT00834249|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
464911|NCT00834249|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
464913|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464915|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464916|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464917|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464918|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464919|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464920|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464921|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464922|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464923|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
464924|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
464925|NCT00834236|B3|Baseline|Total|Total of all reporting groups
464926|NCT00834236|B2|Baseline|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464927|NCT00834236|B1|Baseline|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464928|NCT00834236|P2|Participant Flow|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464929|NCT00834236|P1|Participant Flow|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464930|NCT00834236|O2|Outcome|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464931|NCT00834236|O1|Outcome|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464932|NCT00834236|E2|Reported Event|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464933|NCT00834236|E1|Reported Event|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
464934|NCT00834210|B3|Baseline|Total|Total of all reporting groups
464935|NCT00834210|B2|Baseline|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
464936|NCT00834210|B1|Baseline|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
464937|NCT00834210|P2|Participant Flow|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
464938|NCT00834210|P1|Participant Flow|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
464939|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
464940|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
464941|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
464942|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
464943|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
464944|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
464945|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
464946|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
464947|NCT00834210|E2|Reported Event|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
464948|NCT00834210|E1|Reported Event|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
464949|NCT00834197|B3|Baseline|Total|Total of all reporting groups
464950|NCT00834197|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
464951|NCT00834197|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
464952|NCT00834197|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
464953|NCT00834197|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
464954|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
464955|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
464956|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
464957|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
464958|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
464959|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
464960|NCT00834171|B3|Baseline|Total|Total of all reporting groups
464961|NCT00834171|B2|Baseline|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
464962|NCT00834171|B1|Baseline|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
464963|NCT00834171|P2|Participant Flow|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
464964|NCT00834171|P1|Participant Flow|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
464965|NCT00834171|O2|Outcome|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
464966|NCT00834171|O1|Outcome|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
464967|NCT00834171|E2|Reported Event|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
464968|NCT00834171|E1|Reported Event|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
464969|NCT00834132|B3|Baseline|Total|Total of all reporting groups
464970|NCT00834132|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
464971|NCT00834132|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
464972|NCT00834132|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
464973|NCT00834132|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
464974|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
464975|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
464976|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
464977|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
464978|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
464979|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
464980|NCT00834106|B3|Baseline|Total|Total of all reporting groups
464981|NCT00834106|B2|Baseline|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464982|NCT00834106|B1|Baseline|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464983|NCT00834106|P2|Participant Flow|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464984|NCT00834106|P1|Participant Flow|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464985|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464986|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464987|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464988|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464989|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464990|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464991|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464992|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464993|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464994|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464995|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464996|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464997|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
464998|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
464999|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
465000|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
465001|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
465002|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
465003|NCT00834106|O2|Outcome|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
465004|NCT00834106|O1|Outcome|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
465005|NCT00834106|E2|Reported Event|Placebo|Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
465006|NCT00834106|E1|Reported Event|qHPV|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
465007|NCT00834080|B1|Baseline|VIVITROL, 380mg|
465008|NCT00834080|P1|Participant Flow|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
465009|NCT00834080|O1|Outcome|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
465010|NCT00834080|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
465011|NCT00834067|B3|Baseline|Total|Total of all reporting groups
465177|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
465935|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
465012|NCT00834067|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
465013|NCT00834067|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
465014|NCT00834067|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
465015|NCT00834067|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
465016|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465017|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465018|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465019|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465020|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465021|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465022|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465023|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465024|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465025|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465026|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465027|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465028|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465029|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465030|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465031|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465032|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
465033|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
465034|NCT00834041|B3|Baseline|Total|Total of all reporting groups
465035|NCT00834041|B2|Baseline|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465036|NCT00834041|B1|Baseline|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465037|NCT00834041|P2|Participant Flow|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465038|NCT00834041|P1|Participant Flow|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465039|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465040|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465041|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465042|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465043|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465044|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465045|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465046|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465047|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465048|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465049|NCT00834041|E2|Reported Event|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
465050|NCT00834041|E1|Reported Event|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
465051|NCT00833989|B5|Baseline|Total|Total of all reporting groups
465052|NCT00833989|B4|Baseline|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465053|NCT00833989|B3|Baseline|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465178|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
465400|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465401|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465054|NCT00833989|B2|Baseline|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465055|NCT00833989|B1|Baseline|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465056|NCT00833989|P4|Participant Flow|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465057|NCT00833989|P3|Participant Flow|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465058|NCT00833989|P2|Participant Flow|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 milligram per kilogram (mg/kg)of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465059|NCT00833989|P1|Participant Flow|Placebo|Eligible participants received 0.9% Sodium chloride as an intravenous (IV) infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465060|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465061|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465062|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465063|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465064|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465065|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465066|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465067|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465068|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465069|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465070|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465071|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465072|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465073|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465074|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465075|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465076|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465077|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465078|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465079|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465080|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465081|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465082|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465083|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465084|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465085|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465086|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465087|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465088|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465089|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465090|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465091|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465402|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465092|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465093|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465094|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465095|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465096|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465097|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465098|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465099|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465100|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465101|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465102|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465103|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465104|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465105|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465106|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465107|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465108|NCT00833989|O3|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465109|NCT00833989|O2|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465110|NCT00833989|O1|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465403|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465111|NCT00833989|O3|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465112|NCT00833989|O2|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465113|NCT00833989|O1|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465114|NCT00833989|O3|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465115|NCT00833989|O2|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465116|NCT00833989|O1|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465117|NCT00833989|O3|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465118|NCT00833989|O2|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465119|NCT00833989|O1|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465120|NCT00833989|O3|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465121|NCT00833989|O2|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465122|NCT00833989|O1|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465123|NCT00833989|O3|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465124|NCT00833989|O2|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465125|NCT00833989|O1|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465126|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465127|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465128|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465129|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465130|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465131|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465132|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465133|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465134|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465135|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465136|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465137|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465138|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465139|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465140|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465141|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465142|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465143|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465144|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465145|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465146|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465147|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465148|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465404|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465149|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465150|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465151|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465152|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465153|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465154|NCT00833989|O4|Outcome|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465155|NCT00833989|O3|Outcome|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465156|NCT00833989|O2|Outcome|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465157|NCT00833989|O1|Outcome|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465158|NCT00833989|E4|Reported Event|GSK249320 15 mg/kg|Eligible participants received GSK249320, 15mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks
465159|NCT00833989|E3|Reported Event|GSK249320 5 mg/kg|Eligible participants received GSK249320, 5mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465160|NCT00833989|E2|Reported Event|GSK249320 1 mg/kg|Eligible participants received GSK249320, 1 mg/kg of body weight as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465161|NCT00833989|E1|Reported Event|Placebo|Eligible participants received 0.9% Sodium chloride as an IV infusion via a programmable infusion pump. Each participant received two IV doses 9 ±1 days apart, where the first dose was administered 24-72 hours post stroke. Assessments for safety, pharmacokinetics and pharmacodynamics markers were extended to at least 16 weeks.
465162|NCT00833976|B1|Baseline|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
465163|NCT00833976|P1|Participant Flow|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
465164|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
465165|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
465166|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
465167|NCT00833976|E1|Reported Event|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
465168|NCT00833937|B3|Baseline|Total|Total of all reporting groups
465169|NCT00833937|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
465170|NCT00833937|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
465171|NCT00833937|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
465172|NCT00833937|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
465173|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
465174|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
465175|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
465176|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
465179|NCT00833924|B1|Baseline|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
465180|NCT00833924|P1|Participant Flow|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
465181|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
465182|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
465183|NCT00833924|E1|Reported Event|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
465184|NCT00833911|B1|Baseline|300 mg Tramadol HCl OAD|
465185|NCT00833911|P1|Participant Flow|300 mg Tramadol HCl OAD|
465186|NCT00833911|O3|Outcome|12-months Safety|
465187|NCT00833911|O2|Outcome|6-months Safety|
465188|NCT00833911|O1|Outcome|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
465189|NCT00833911|E3|Reported Event|12-months Safety|
465190|NCT00833911|E2|Reported Event|6-months Safety|
465191|NCT00833911|E1|Reported Event|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
465192|NCT00833898|B3|Baseline|Total|Total of all reporting groups
465193|NCT00833898|B2|Baseline|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465194|NCT00833898|B1|Baseline|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465195|NCT00833898|P2|Participant Flow|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465196|NCT00833898|P1|Participant Flow|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465197|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465198|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465199|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465200|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465201|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465202|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465203|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465204|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465205|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465206|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465207|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465208|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465209|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465210|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465348|NCT00833755|P1|Participant Flow|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
465211|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465212|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465213|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465214|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465215|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465216|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465217|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465218|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465219|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465220|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465221|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465222|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465223|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465224|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465225|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465226|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465227|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465228|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465229|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465230|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465231|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465232|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465233|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465234|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465235|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465236|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465237|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465238|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465264|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465239|NCT00833898|E2|Reported Event|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
465240|NCT00833898|E1|Reported Event|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
465241|NCT00833859|B1|Baseline|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
465242|NCT00833859|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
465243|NCT00833859|O1|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
465244|NCT00833859|O1|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
465245|NCT00833859|O1|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
465246|NCT00833859|O1|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
465247|NCT00833859|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
465248|NCT00833833|B7|Baseline|Total|Total of all reporting groups
465249|NCT00833833|B6|Baseline|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
465250|NCT00833833|B5|Baseline|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465251|NCT00833833|B4|Baseline|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465252|NCT00833833|B3|Baseline|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465253|NCT00833833|B2|Baseline|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465254|NCT00833833|B1|Baseline|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465255|NCT00833833|P6|Participant Flow|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
465256|NCT00833833|P5|Participant Flow|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465257|NCT00833833|P4|Participant Flow|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465258|NCT00833833|P3|Participant Flow|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465259|NCT00833833|P2|Participant Flow|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465260|NCT00833833|P1|Participant Flow|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465261|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
465262|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465263|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
465346|NCT00833755|P3|Participant Flow|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
465265|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
465266|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465267|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
465268|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465269|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
465270|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465271|NCT00833833|O4|Outcome|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
465272|NCT00833833|O3|Outcome|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
465273|NCT00833833|O2|Outcome|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
465274|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465275|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465276|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465277|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465278|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465279|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465280|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465281|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465282|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465283|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
465284|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465285|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465286|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465287|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465288|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465289|NCT00833833|E8|Reported Event|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
465290|NCT00833833|E7|Reported Event|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
465399|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465291|NCT00833833|E6|Reported Event|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
465292|NCT00833833|E5|Reported Event|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
465293|NCT00833833|E4|Reported Event|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465294|NCT00833833|E3|Reported Event|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465295|NCT00833833|E2|Reported Event|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465296|NCT00833833|E1|Reported Event|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
465297|NCT00833794|B3|Baseline|Total|Total of all reporting groups
465298|NCT00833794|B2|Baseline|2 Placebo|
465299|NCT00833794|B1|Baseline|1 Tramadol Once A Day|
465300|NCT00833794|P2|Participant Flow|2 Placebo|
465301|NCT00833794|P1|Participant Flow|1 Tramadol Once A Day|
465302|NCT00833794|O2|Outcome|2 Placebo|
465303|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465304|NCT00833794|O2|Outcome|2 Placebo|
465305|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465306|NCT00833794|O2|Outcome|2 Placebo|
465307|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465308|NCT00833794|O2|Outcome|2 Placebo|
465309|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465310|NCT00833794|O2|Outcome|2 Placebo|
465311|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465312|NCT00833794|O2|Outcome|2 Placebo|
465313|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465314|NCT00833794|O2|Outcome|2 Placebo|
465315|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465316|NCT00833794|O4|Outcome|Tramadol Once A Day 300 mg|
465317|NCT00833794|O3|Outcome|Tramadol Once A Day 200 mg|
465318|NCT00833794|O2|Outcome|2 Placebo|
465319|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465320|NCT00833794|O2|Outcome|2 Placebo|
465321|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465322|NCT00833794|O2|Outcome|2 Placebo|
465323|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
465324|NCT00833794|E2|Reported Event|2 Placebo|
465325|NCT00833794|E1|Reported Event|1 Tramadol Once A Day|
465326|NCT00833781|B3|Baseline|Total|Total of all reporting groups
465327|NCT00833781|B2|Baseline|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
465328|NCT00833781|B1|Baseline|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
465329|NCT00833781|P2|Participant Flow|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
465330|NCT00833781|P1|Participant Flow|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
465331|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465332|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465333|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465334|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465335|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465336|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465337|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465338|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
465339|NCT00833781|E1|Reported Event|mRNA Transfected DCs|
465340|NCT00833755|B5|Baseline|Total|Total of all reporting groups
465341|NCT00833755|B4|Baseline|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
465342|NCT00833755|B3|Baseline|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
465343|NCT00833755|B2|Baseline|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
465344|NCT00833755|B1|Baseline|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
465345|NCT00833755|P4|Participant Flow|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
465347|NCT00833755|P2|Participant Flow|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
465349|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
465350|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
465351|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
465352|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
465353|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
465354|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
465355|NCT00833755|O2|Outcome|Opioid - Placebo|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
465356|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
465357|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
465358|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
465359|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
465360|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
465361|NCT00833755|E4|Reported Event|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
465362|NCT00833755|E3|Reported Event|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
465363|NCT00833755|E2|Reported Event|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
465364|NCT00833755|E1|Reported Event|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
465365|NCT00833703|B3|Baseline|Total|Total of all reporting groups
465366|NCT00833703|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
465367|NCT00833703|B1|Baseline|Placebo|0.2 mL/kg/day matching placebo solution once daily
465368|NCT00833703|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
465369|NCT00833703|P1|Participant Flow|Placebo|0.2 mL/kg/day matching placebo solution once daily
465370|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
465371|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
465372|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
465373|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
465374|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
465375|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
465376|NCT00833703|E2|Reported Event|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
465377|NCT00833703|E1|Reported Event|Placebo|0.2 mL/kg/day matching placebo solution once daily
465378|NCT00833690|B4|Baseline|Total|Total of all reporting groups
465379|NCT00833690|B3|Baseline|[C.]Moderate|Inosine to produce a moderate urate elevation
465380|NCT00833690|B2|Baseline|[B:]Mild|Inosine to produce a mild urate elevation
465381|NCT00833690|B1|Baseline|[A:]Placebo|Placebo to produce no urate elevation
465382|NCT00833690|P3|Participant Flow|[C.]Moderate|Inosine to produce a moderate urate elevation
465383|NCT00833690|P2|Participant Flow|[B:]Mild|Inosine to produce a mild urate elevation
465384|NCT00833690|P1|Participant Flow|[A:]Placebo|Placebo to produce no urate elevation
465385|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465386|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465387|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465388|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465389|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465390|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465391|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465392|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465393|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465394|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465395|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465396|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465397|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465398|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465405|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465406|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465407|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465408|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465409|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465410|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465411|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465412|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465413|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465414|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465415|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465416|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465417|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465418|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465419|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465420|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465421|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465422|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465423|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465424|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465425|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465426|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465427|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465428|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465429|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465430|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465431|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465432|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465433|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465434|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465435|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465436|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465437|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465438|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465439|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465440|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465441|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465442|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465443|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465444|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465445|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465446|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465447|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465448|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465449|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465450|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465451|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465452|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465453|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465454|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465455|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465456|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465457|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465458|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465459|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465460|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465461|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465462|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465463|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465464|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465465|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465466|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465467|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465468|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465469|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465470|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465471|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465472|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465473|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465474|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465475|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465476|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465477|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465478|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465479|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465480|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465481|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465482|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465483|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465484|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465485|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465486|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465487|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465488|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465489|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465490|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465491|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465492|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465493|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465494|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465495|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465496|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465497|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465498|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465499|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
465500|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
465501|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
465502|NCT00833690|E3|Reported Event|[C.]Moderate|Inosine to produce a moderate urate elevation
465503|NCT00833690|E2|Reported Event|[B:]Mild|Inosine to produce a mild urate elevation
465504|NCT00833690|E1|Reported Event|[A:]Placebo|Placebo to produce no urate elevation
465505|NCT00833664|B3|Baseline|Total|Total of all reporting groups
465506|NCT00833664|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
465507|NCT00833664|B1|Baseline|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
465508|NCT00833664|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
465509|NCT00833664|P1|Participant Flow|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
465510|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
465511|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
465512|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
465513|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
465514|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
465515|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
465516|NCT00833638|B4|Baseline|Total|Total of all reporting groups
465517|NCT00833638|B3|Baseline|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465518|NCT00833638|B2|Baseline|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465519|NCT00833638|B1|Baseline|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465520|NCT00833638|P3|Participant Flow|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465521|NCT00833638|P2|Participant Flow|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465522|NCT00833638|P1|Participant Flow|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465523|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465524|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465525|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465526|NCT00833638|O1|Outcome|Tadalafil 5 mg Double-blind|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465527|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465528|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465529|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465530|NCT00833638|O1|Outcome|Placebo Double-blind|No drug during baseline period, placeob for 14 days, then will continue at 5 mg for 14 days.
465531|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465532|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465533|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465534|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465535|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465536|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465537|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465538|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465539|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465540|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465541|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465542|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465543|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465544|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465545|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465546|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465547|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465548|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465549|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465550|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465551|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465552|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
465553|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
465554|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
465555|NCT00833638|E6|Reported Event|Placebo to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving placebo in the double-blind period.
465556|NCT00833638|E5|Reported Event|Tadalafil 5 mg to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving tadalafil 5 mg in the double-blind period.
465557|NCT00833638|E4|Reported Event|Tadalafil 2.5 mg to Tadalafil 5 mg|Participants receiving tadalafil 5 mg in the open-label period after receiving tadalafil 2.5 mg in the double-blind period.
465558|NCT00833638|E3|Reported Event|Placebo|No drug during baseline period followed by placebo for 14 days.
465559|NCT00833638|E2|Reported Event|Tadalafil 5 mg|No drug during baseline period followed by tadalafil 5 mg for 14 days.
465560|NCT00833638|E1|Reported Event|Tadalafil 2.5 mg|No drug during baseline period followed by tadalafil 2.5 mg for 14 days.
465561|NCT00833586|B3|Baseline|Total|Total of all reporting groups
465562|NCT00833586|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
465563|NCT00833586|B1|Baseline|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
465564|NCT00833586|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
465565|NCT00833586|P1|Participant Flow|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
465566|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
465567|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
465568|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
465569|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
465570|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
465571|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
465572|NCT00833560|B1|Baseline|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
465573|NCT00833560|P1|Participant Flow|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
465574|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
465575|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
465576|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
465577|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
465578|NCT00833560|E1|Reported Event|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
465579|NCT00833547|B3|Baseline|Total|Total of all reporting groups
465580|NCT00833547|B2|Baseline|Placebo|placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights
465581|NCT00833547|B1|Baseline|Eszopiclone|3mg of eszopiclone at bedtime on 2 consecutive nights
465582|NCT00833547|P2|Participant Flow|Eszopiclone|3mg of eszopiclone at bedtime for two consecutive nights
465583|NCT00833547|P1|Participant Flow|Placebo|placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
465584|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
465585|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
465586|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
465587|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
465588|NCT00833547|E2|Reported Event|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
465589|NCT00833547|E1|Reported Event|Eszopiclone|3mg of eszopiclone on two consecutive nights
465590|NCT00833521|B3|Baseline|Total|Total of all reporting groups
465591|NCT00833521|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
465592|NCT00833521|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
465593|NCT00833521|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
465594|NCT00833521|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
465595|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
465596|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
465597|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
465598|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
465599|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
465600|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
465601|NCT00833482|B3|Baseline|Total|Total of all reporting groups
465602|NCT00833482|B2|Baseline|Poor Metabolizers (PM)|Participants without a functional CYP2C19 allele (poor metabolizers, or PM).
465603|NCT00833482|B1|Baseline|Extensive Metabolizers (EM)|Participants with functional CYP2C19 alleles (extensive metabolizers, or EM).
465604|NCT00833482|P6|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465605|NCT00833482|P5|Participant Flow|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
465606|NCT00833482|P4|Participant Flow|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465607|NCT00833482|P3|Participant Flow|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465608|NCT00833482|P2|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465609|NCT00833482|P1|Participant Flow|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465610|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465611|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
465612|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465613|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465614|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465615|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465616|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465617|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
465618|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465619|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465620|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465621|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465622|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465623|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
465624|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465625|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465626|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465627|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465628|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465629|NCT00833482|O5|Outcome|Atazanavir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
465630|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465631|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465632|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465633|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465634|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465635|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
465636|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465637|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465638|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465639|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465640|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465641|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465642|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465643|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465644|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mg QD + Voriconazole, 200 mg BID|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465936|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
465645|NCT00833482|O1|Outcome|Voriconazole, 200 BID|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465646|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465647|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465648|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465649|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465650|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465651|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465652|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465653|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EMs received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465654|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465655|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465656|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465657|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465658|NCT00833482|E6|Reported Event|Atazanazvir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
465659|NCT00833482|E5|Reported Event|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465660|NCT00833482|E4|Reported Event|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
465661|NCT00833482|E3|Reported Event|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
465662|NCT00833482|E2|Reported Event|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal
465663|NCT00833482|E1|Reported Event|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
465664|NCT00833469|B1|Baseline|Escitalopram|"Flexible dose escitalopram 10mg~Escitalopram: Once daily by mouth"
465665|NCT00833469|P1|Participant Flow|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
465666|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
465667|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
465668|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
465669|NCT00833469|E1|Reported Event|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
465670|NCT00833443|B3|Baseline|Total|Total of all reporting groups
465706|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
465671|NCT00833443|B2|Baseline|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
465672|NCT00833443|B1|Baseline|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
465673|NCT00833443|P2|Participant Flow|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
465674|NCT00833443|P1|Participant Flow|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
465675|NCT00833443|O2|Outcome|NOT Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication NON-adherence
465676|NCT00833443|O1|Outcome|Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication adherence
465677|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
465678|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
465679|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
465680|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
465681|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
465707|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
465708|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
465791|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
467724|NCT00828178|B2|Baseline|Placebo|corn starch
465682|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
465683|NCT00833443|E2|Reported Event|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
465684|NCT00833443|E1|Reported Event|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
465685|NCT00833417|B3|Baseline|Total|Total of all reporting groups
465686|NCT00833417|B2|Baseline|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465687|NCT00833417|B1|Baseline|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465688|NCT00833417|P2|Participant Flow|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465689|NCT00833417|P1|Participant Flow|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465690|NCT00833417|O1|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465691|NCT00833417|O1|Outcome|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465692|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465693|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465694|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465695|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465696|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465697|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465698|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465699|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465700|NCT00833417|E1|Reported Event|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
465701|NCT00833365|B3|Baseline|Total|Total of all reporting groups
465702|NCT00833365|B2|Baseline|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
465703|NCT00833365|B1|Baseline|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
465704|NCT00833365|P2|Participant Flow|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
465705|NCT00833365|P1|Participant Flow|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
465709|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
465710|NCT00833365|E2|Reported Event|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
465711|NCT00833365|E1|Reported Event|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
465712|NCT00833248|B3|Baseline|Total|Total of all reporting groups
465713|NCT00833248|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465714|NCT00833248|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465715|NCT00833248|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465716|NCT00833248|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465717|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465718|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465719|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465720|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465721|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465722|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465723|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465724|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465725|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465726|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465727|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465937|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
465728|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465729|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465730|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465731|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465732|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465733|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465734|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465735|NCT00833248|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
465736|NCT00833248|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
465737|NCT00833092|B3|Baseline|Total|Total of all reporting groups
465738|NCT00833092|B2|Baseline|Magnesium|300 milligrams of magnesium daily
465739|NCT00833092|B1|Baseline|Sugar Pill|zero magnesium supplementation
465740|NCT00833092|P2|Participant Flow|Magnesium|300 milligrams of magnesium daily
465741|NCT00833092|P1|Participant Flow|Sugar Pill|zero magnesium supplementation
465742|NCT00833092|O2|Outcome|Magnesium|300 milligrams of magnesium daily
465743|NCT00833092|O1|Outcome|Sugar Pill|zero magnesium supplementation
465744|NCT00833092|E2|Reported Event|Magnesium|300 milligrams of magnesium daily
465745|NCT00833092|E1|Reported Event|Sugar Pill|zero magnesium supplementation
465746|NCT00833053|B3|Baseline|Total|Total of all reporting groups
465747|NCT00833053|B2|Baseline|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465748|NCT00833053|B1|Baseline|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465749|NCT00833053|P2|Participant Flow|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465750|NCT00833053|P1|Participant Flow|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465751|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465752|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465753|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465754|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465755|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465756|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465757|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465758|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465759|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465760|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465761|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465762|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465763|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465764|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465765|NCT00833053|E2|Reported Event|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
465766|NCT00833053|E1|Reported Event|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
465767|NCT00833040|B1|Baseline|Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to the effective dosage of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken as needed for breakthrough pain.~During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active (dosage determined in Titration Phase) and three placebo doses taken in random order per. One NanoTab™ was taken as needed for breakthrough pain."
465768|NCT00833040|P6|Participant Flow|Sequence 6|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 6 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 10th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
465769|NCT00833040|P5|Participant Flow|Sequence 5|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 5 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
465770|NCT00833040|P4|Participant Flow|Sequence 4|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 4 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 5th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
465771|NCT00833040|P3|Participant Flow|Sequence 3|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 3 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 5th, and 9th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
465772|NCT00833040|P2|Participant Flow|Sequence 2|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 2 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
465773|NCT00833040|P1|Participant Flow|Sequence 1|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 1 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
465774|NCT00833040|O2|Outcome|Double Blind Phase of 3 Pbo Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
465775|NCT00833040|O1|Outcome|Double Blind Phase of 7 Sufentanil Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
465776|NCT00833040|E1|Reported Event|Titration of Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to their personal effective strength of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken for each episode of breakthrough pain.~During the Double-Blind Phase, patients were randomized to one of six treatment sequences, each of which included seven active doses (the strength determined in Titration Phase) and three placebo doses. The ten doses were in random order. One NanoTab™ was taken for each episode of breakthrough pain."
465777|NCT00833027|B1|Baseline|Sitagliptin 100mg|
465778|NCT00833027|P1|Participant Flow|Sitagliptin 100mg|
465779|NCT00833027|O1|Outcome|Sitagliptin 100mg|
465780|NCT00833027|O1|Outcome|Sitagliptin 100mg|
465781|NCT00833027|E1|Reported Event|Sitagliptin 100mg|
465782|NCT00832975|B1|Baseline|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
465783|NCT00832975|P1|Participant Flow|St Jude Medical ICD/CRT-D|St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients
465784|NCT00832975|O1|Outcome|Single Arm|St Jude Medical ICD/CRT-D Device implanted patients
465785|NCT00832975|O1|Outcome|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
465786|NCT00832975|E1|Reported Event|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
465787|NCT00832871|B1|Baseline|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
465788|NCT00832871|P1|Participant Flow|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
465789|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
465790|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
466223|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
465792|NCT00832871|E1|Reported Event|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
465793|NCT00832819|B4|Baseline|Total|Total of all reporting groups
465794|NCT00832819|B3|Baseline|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465795|NCT00832819|B2|Baseline|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465796|NCT00832819|B1|Baseline|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (Area under the curve (AUC) 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465797|NCT00832819|P3|Participant Flow|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465798|NCT00832819|P2|Participant Flow|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465799|NCT00832819|P1|Participant Flow|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465800|NCT00832819|O1|Outcome|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465801|NCT00832819|E3|Reported Event|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465802|NCT00832819|E2|Reported Event|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465803|NCT00832819|E1|Reported Event|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
465804|NCT00832780|B1|Baseline|60 Gy Using 12 Gy Per Fraction Over 5 Fractions|Radiation dose of 60 Gy administered in 5 fractions of 12 Gy each.
465805|NCT00832780|P1|Participant Flow|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
465806|NCT00832780|O1|Outcome|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
465807|NCT00832780|O1|Outcome|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
465808|NCT00832780|O1|Outcome|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
465809|NCT00832780|O1|Outcome|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
465810|NCT00832780|O1|Outcome|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
465811|NCT00832780|E1|Reported Event|Stereotactic Body Radiation (SBRT)|"60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days~Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%."
465812|NCT00832767|B3|Baseline|Total|Total of all reporting groups
465813|NCT00832767|B2|Baseline|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465814|NCT00832767|B1|Baseline|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465815|NCT00832767|P2|Participant Flow|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465816|NCT00832767|P1|Participant Flow|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465817|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465818|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465819|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465820|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465821|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465822|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465823|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465824|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465825|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465826|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465827|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465828|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465829|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465830|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465831|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465832|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465833|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465834|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465835|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465836|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465837|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465838|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465839|NCT00832767|O2|Outcome|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465840|NCT00832767|O1|Outcome|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465841|NCT00832767|E2|Reported Event|Four Port|"Four Port Laparoscopic Cholecystectomy~Four Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure."
465938|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
465842|NCT00832767|E1|Reported Event|SILS Port|"SILS™ Port Laparoscopic Cholecystectomy~SILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure."
465843|NCT00832650|B4|Baseline|Total|Total of all reporting groups
465844|NCT00832650|B3|Baseline|Solifenacin|Solifenacin 10 mg capsule once daily
465845|NCT00832650|B2|Baseline|Placebo|Matched placebo tablet or capsule
465846|NCT00832650|B1|Baseline|Fesoterodine|Fesoterodine 8 mg tablet once daily
465847|NCT00832650|P3|Participant Flow|Solifenacin|Solifenacin 10 mg capsule once daily
465848|NCT00832650|P2|Participant Flow|Placebo|Matched placebo tablet or capsule
465849|NCT00832650|P1|Participant Flow|Fesoterodine|Fesoterodine 8 mg tablet once daily
465850|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465851|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465852|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465853|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465854|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465855|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465856|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465857|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465858|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465859|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465860|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465861|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465862|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465863|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465864|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465865|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465866|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465867|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465868|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465869|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465870|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465871|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465872|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465873|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465874|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
465875|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
465876|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
465877|NCT00832650|E3|Reported Event|Solifenacin|Solifenacin 10 mg capsule once daily
465878|NCT00832650|E2|Reported Event|Placebo|Matched placebo tablet or capsule
465879|NCT00832650|E1|Reported Event|Fesoterodine|Fesoterodine 8 mg tablet once daily
465880|NCT00832637|B1|Baseline|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465881|NCT00832637|P1|Participant Flow|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465882|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465898|NCT00832585|B1|Baseline|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
466042|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
465883|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465884|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465885|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465886|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465887|NCT00832637|E1|Reported Event|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
465888|NCT00832624|B1|Baseline|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
465889|NCT00832624|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
465890|NCT00832624|O1|Outcome|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
465891|NCT00832624|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
465892|NCT00832598|B1|Baseline|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
465893|NCT00832598|P1|Participant Flow|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
465894|NCT00832598|O1|Outcome|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
465895|NCT00832598|O1|Outcome|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
465896|NCT00832598|O1|Outcome|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
465897|NCT00832598|E1|Reported Event|PET Imaging|We will perform [18F]FACBC PET and [18F]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
465923|NCT00832455|B1|Baseline|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
465924|NCT00832455|P1|Participant Flow|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
465925|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|
465899|NCT00832585|P1|Participant Flow|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
465900|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
465901|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
465902|NCT00832585|E1|Reported Event|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
465903|NCT00832572|B3|Baseline|Total|Total of all reporting groups
465904|NCT00832572|B2|Baseline|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
465905|NCT00832572|B1|Baseline|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
465906|NCT00832572|P2|Participant Flow|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
465907|NCT00832572|P1|Participant Flow|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
465908|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
465909|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
465910|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
465911|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
465912|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
465913|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
465914|NCT00832572|E4|Reported Event|Ranolazine/Placebo, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving placebo).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
465915|NCT00832572|E3|Reported Event|Ranolazine/Placebo, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving ranolazine).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
465916|NCT00832572|E2|Reported Event|Placebo/Ranolazine, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving ranolazine).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
465917|NCT00832572|E1|Reported Event|Placebo/Ranolazine, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving placebo).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
465918|NCT00832520|B1|Baseline|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
465919|NCT00832520|P1|Participant Flow|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
465920|NCT00832520|O1|Outcome|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
465921|NCT00832520|O1|Outcome|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
465922|NCT00832520|E1|Reported Event|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
465939|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
465940|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
465941|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
465942|NCT00832455|E1|Reported Event|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
465943|NCT00832416|B5|Baseline|Total|Total of all reporting groups
465944|NCT00832416|B4|Baseline|4: Placebo|
465945|NCT00832416|B3|Baseline|3: Tramadol Once A Day 300mg|
465946|NCT00832416|B2|Baseline|2: Tramadol Once A Day 200mg|
465947|NCT00832416|B1|Baseline|1: Tramadol Once A Day 100mg|
465948|NCT00832416|P4|Participant Flow|4: Placebo|
465949|NCT00832416|P3|Participant Flow|3: Tramadol Once A Day 300mg|
465950|NCT00832416|P2|Participant Flow|2: Tramadol Once A Day 200mg|
465951|NCT00832416|P1|Participant Flow|1: Tramadol Once A Day 100mg|
465952|NCT00832416|O4|Outcome|4: Placebo|
465953|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465954|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465955|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465956|NCT00832416|O4|Outcome|4: Placebo|
465957|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465958|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465959|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465960|NCT00832416|O4|Outcome|4: Placebo|
465961|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465962|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465963|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465964|NCT00832416|O4|Outcome|4: Placebo|
465965|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465966|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465967|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465968|NCT00832416|O4|Outcome|4: Placebo|
465969|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465970|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465971|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465972|NCT00832416|O4|Outcome|4: Placebo|
465973|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465974|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465975|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465976|NCT00832416|O4|Outcome|4: Placebo|
465977|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465978|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465979|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465980|NCT00832416|O4|Outcome|4: Placebo|
465981|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
465982|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
465983|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
465984|NCT00832416|E4|Reported Event|4: Placebo|
465985|NCT00832416|E3|Reported Event|3: Tramadol Once A Day 300mg|
465986|NCT00832416|E2|Reported Event|2: Tramadol Once A Day 200mg|
465987|NCT00832416|E1|Reported Event|1: Tramadol Once A Day 100mg|
465988|NCT00832390|B4|Baseline|Total|Total of all reporting groups
465989|NCT00832390|B3|Baseline|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
465990|NCT00832390|B2|Baseline|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
465991|NCT00832390|B1|Baseline|Sitagliptin 100 mg q.d. (Once Daily)|
465992|NCT00832390|P3|Participant Flow|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
465993|NCT00832390|P2|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
465994|NCT00832390|P1|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily)|
465995|NCT00832390|O3|Outcome|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
465996|NCT00832390|O2|Outcome|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
465997|NCT00832390|O1|Outcome|Sitagliptin 100 mg q.d. (Once Daily)|
465998|NCT00832390|E3|Reported Event|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
465999|NCT00832390|E2|Reported Event|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
466000|NCT00832390|E1|Reported Event|Sitagliptin 100 mg q.d. (Once Daily)|
466001|NCT00832377|B1|Baseline|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
466002|NCT00832377|P1|Participant Flow|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
466003|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
466004|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
466005|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
466006|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
466007|NCT00832377|E1|Reported Event|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
466043|NCT00832130|E2|Reported Event|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466044|NCT00832130|E1|Reported Event|Manual Mini System|Treatment with experimental Manual Mini System
466045|NCT00832117|B3|Baseline|Total|Total of all reporting groups
469008|NCT00824382|B1|Baseline|Placebo|Placebo
466008|NCT00832338|B1|Baseline|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
466009|NCT00832338|P1|Participant Flow|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
466010|NCT00832338|O1|Outcome|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
466011|NCT00832338|E1|Reported Event|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
466012|NCT00832299|B1|Baseline|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
466013|NCT00832299|P1|Participant Flow|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
466014|NCT00832299|O1|Outcome|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
466015|NCT00832299|O1|Outcome|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
466016|NCT00832299|E1|Reported Event|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
466017|NCT00832260|B1|Baseline|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
466018|NCT00832260|P1|Participant Flow|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
466019|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
466020|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
466021|NCT00832260|E1|Reported Event|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
466022|NCT00832130|B3|Baseline|Total|Total of all reporting groups
466023|NCT00832130|B2|Baseline|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466024|NCT00832130|B1|Baseline|Manual Mini System|Treatment with experimental Manual Mini System
466025|NCT00832130|P2|Participant Flow|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466026|NCT00832130|P1|Participant Flow|Manual Mini System|Treatment with experimental Manual Mini System
466027|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466028|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
466029|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466030|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
466031|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466032|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
466033|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466034|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
466035|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466036|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
466037|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466038|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
466039|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466040|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
466041|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
466046|NCT00832117|B2|Baseline|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466047|NCT00832117|B1|Baseline|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466048|NCT00832117|P1|Participant Flow|All Enrolled Participants|Participants received both ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 and ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle.
466049|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466050|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466051|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466052|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466053|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466054|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466055|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466056|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466057|NCT00832117|O1|Outcome|All Treated Participants|All participants who received at least 1 dose of either ixabepilone or carboplatin
466058|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466059|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466060|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466061|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466062|NCT00832117|E2|Reported Event|Ixa 32 mg/m2 +Cis 80 mg/m2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
466063|NCT00832117|E1|Reported Event|Ixa 32 mg/m2 + Cis 60 mg/m2|6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
466064|NCT00832091|B3|Baseline|Total|Total of all reporting groups
466065|NCT00832091|B2|Baseline|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
466066|NCT00832091|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
466067|NCT00832091|P2|Participant Flow|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
466068|NCT00832091|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
466069|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
466070|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
466071|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
466072|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
466073|NCT00832091|E2|Reported Event|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
466074|NCT00832091|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
466075|NCT00832078|B1|Baseline|Entire Study Population|
466076|NCT00832078|P2|Participant Flow|Group B|Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant
466077|NCT00832078|P1|Participant Flow|Group A|Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant
466078|NCT00832078|O2|Outcome|Standard Catheter SC|The Stanard catheter SpeediCath (SC)
466079|NCT00832078|O1|Outcome|Test Catheter SCCM|The Test catheter SpeediCath Compact Male (SCCM)
466080|NCT00832078|E2|Reported Event|Standard Catheter|
466081|NCT00832078|E1|Reported Event|Test Catheter|
466082|NCT00832000|B1|Baseline|All Study Participants|All participants received all inerventions; therefore, we combined all participants into one Arm/Group.
466083|NCT00832000|P2|Participant Flow|Placebo Then Mexiletine|"30 Participants will receive placebo for 4 weeks, then no intervention for 1 week, and finally mexiletine for 4 weeks.~Included in analysis* 29 patients~*Modified intention to treat analysis. 1 subject in each not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period."
466084|NCT00832000|P1|Participant Flow|Mexiletine Then Placebo|"29 Participants will receive mexiletine for 4 weeks, then no intervention for 1 week, and finally placebo for 4 weeks.~Included in anaysis*: 28 patients~*Modified intention to treat analysis. 1 subject in each group not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period"
466085|NCT00832000|O4|Outcome|Placebo - Period 2|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466086|NCT00832000|O3|Outcome|Mexiletine - Period 2|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466087|NCT00832000|O2|Outcome|Placebo - Period 1|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466088|NCT00832000|O1|Outcome|Mexiletine - Period 1|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466089|NCT00832000|O2|Outcome|Placebo|SF-36 physical composite score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
466090|NCT00832000|O1|Outcome|Mexiletine|SF-36 physical composite score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
466091|NCT00832000|O2|Outcome|Placebo|INQoL summary score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
466092|NCT00832000|O1|Outcome|Mexiletine|INQoL summary score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
466093|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude ( as a percentage of baseline measurement) for participants receiving placebo capsules orally three times daily either in period 1 or period 2
466094|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percentage of baseline measreument) for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
466095|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
466096|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right TA for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
466097|NCT00832000|O2|Outcome|Placebo|Average time to open eyes after forced eye closure for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
466098|NCT00832000|O1|Outcome|Mexiletine|Average time to open eyes after forced eye closure for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
466099|NCT00832000|O2|Outcome|Placebo|Average time to open the fist after forced hand grip for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
466100|NCT00832000|O1|Outcome|Mexiletine|Average time to open the fist after forced hand grip for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
466101|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
466102|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right ADM for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
466103|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude (as a percento f baseline measurement) for particpants receiving mexiletine capsules orally three times daily either in period 1 or period 2
466104|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percent of baseline measurement) for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
466105|NCT00832000|O2|Outcome|Placebo|Average 90% to 5% hand grip relaxation time for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
466106|NCT00832000|O1|Outcome|Mexiletine|Average 90% to 5% hand grip relaxation time for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
466107|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced tiredness on placebo capsules orally three times daily in either period 1 or period 2.
466108|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced tiredness on mexiletine 200 mg capsules orally three times daily in either period 1 or period 2.
466109|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced weakness on placebo capsules orally three times daily in either period 1 or period 2.
466110|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced weakness on mexiletine capsules 200 mg orally three times daily in either period 1 or period 2.
466111|NCT00832000|O2|Outcome|Placebo|Participants experiencing pain on placebo capsules orally three times dailyin period 1 or period 2
466112|NCT00832000|O1|Outcome|Mexiletine|Participants experiencing pain on mexiletine capsules 200 mg orally three times daily in period 1 or period 2
466113|NCT00832000|O4|Outcome|Placebo - Period 2|Placebo capsules orally three times dailyperiod 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466114|NCT00832000|O3|Outcome|Mexiletine - Period 2|Mexiletine capsules 200 mg orally three times daily period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466115|NCT00832000|O2|Outcome|Placebo - Period 1|Placebo capsules orally three times dailyperiod 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466116|NCT00832000|O1|Outcome|Mexiletine - Period 1|Mexiletine capsules 200 mg orally three times daily period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
466117|NCT00832000|E2|Reported Event|Placebo Treatment|Adverse events that occurred when patients were taking mexiletine.
466118|NCT00832000|E1|Reported Event|Mexiletine Treatment|Adverse events that occurred when patients were taking placebo.
466119|NCT00831987|B3|Baseline|Total|Total of all reporting groups
466120|NCT00831987|B2|Baseline|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466121|NCT00831987|B1|Baseline|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466122|NCT00831987|P2|Participant Flow|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466123|NCT00831987|P1|Participant Flow|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466124|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466125|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466126|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466127|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466128|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466129|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466130|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466131|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466132|NCT00831987|E2|Reported Event|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466133|NCT00831987|E1|Reported Event|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
466134|NCT00831844|B11|Baseline|Total|Total of all reporting groups
466135|NCT00831844|B10|Baseline|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466136|NCT00831844|B9|Baseline|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466137|NCT00831844|B8|Baseline|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466138|NCT00831844|B7|Baseline|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466139|NCT00831844|B6|Baseline|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466140|NCT00831844|B5|Baseline|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466141|NCT00831844|B4|Baseline|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466142|NCT00831844|B3|Baseline|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466143|NCT00831844|B2|Baseline|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466144|NCT00831844|B1|Baseline|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466145|NCT00831844|P10|Participant Flow|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466218|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466219|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
466146|NCT00831844|P9|Participant Flow|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466147|NCT00831844|P8|Participant Flow|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466148|NCT00831844|P7|Participant Flow|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466149|NCT00831844|P6|Participant Flow|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466150|NCT00831844|P5|Participant Flow|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466151|NCT00831844|P4|Participant Flow|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466152|NCT00831844|P3|Participant Flow|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466153|NCT00831844|P2|Participant Flow|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466154|NCT00831844|P1|Participant Flow|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466155|NCT00831844|O10|Outcome|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466156|NCT00831844|O9|Outcome|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466157|NCT00831844|O8|Outcome|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466158|NCT00831844|O7|Outcome|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466159|NCT00831844|O6|Outcome|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466160|NCT00831844|O5|Outcome|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466161|NCT00831844|O4|Outcome|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466162|NCT00831844|O3|Outcome|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466163|NCT00831844|O2|Outcome|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466220|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466164|NCT00831844|O1|Outcome|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466165|NCT00831844|E10|Reported Event|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466166|NCT00831844|E9|Reported Event|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466167|NCT00831844|E8|Reported Event|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466168|NCT00831844|E7|Reported Event|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466169|NCT00831844|E6|Reported Event|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466170|NCT00831844|E5|Reported Event|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466171|NCT00831844|E4|Reported Event|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466172|NCT00831844|E3|Reported Event|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466173|NCT00831844|E2|Reported Event|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466174|NCT00831844|E1|Reported Event|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
466175|NCT00831779|B3|Baseline|Total|Total of all reporting groups
466176|NCT00831779|B2|Baseline|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
466177|NCT00831779|B1|Baseline|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
466178|NCT00831779|P2|Participant Flow|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
466179|NCT00831779|P1|Participant Flow|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
466180|NCT00831779|O2|Outcome|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
466181|NCT00831779|O1|Outcome|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
466182|NCT00831779|O2|Outcome|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
466183|NCT00831779|O1|Outcome|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
466184|NCT00831779|E2|Reported Event|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
466185|NCT00831779|E1|Reported Event|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
466186|NCT00831766|B3|Baseline|Total|Total of all reporting groups
466187|NCT00831766|B2|Baseline|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
466188|NCT00831766|B1|Baseline|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
466221|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
466222|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466189|NCT00831766|P2|Participant Flow|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
466190|NCT00831766|P1|Participant Flow|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
466191|NCT00831766|O1|Outcome|All Participants Treated at MTD|All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
466192|NCT00831766|O1|Outcome|Phase I Participants|Dose escalation group.
466193|NCT00831766|E2|Reported Event|Phase II: Treatment at MTD|Participants enrolled during Phase II.
466194|NCT00831766|E1|Reported Event|Phase I: Dose Escalation|Participants enrolled during Phase I.
466195|NCT00831753|B3|Baseline|Total|Total of all reporting groups
466196|NCT00831753|B2|Baseline|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
466197|NCT00831753|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
466198|NCT00831753|P2|Participant Flow|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
466199|NCT00831753|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
466200|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
466201|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
466202|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
466203|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
466204|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
466205|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
466206|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
466207|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
466208|NCT00831753|E2|Reported Event|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
466209|NCT00831753|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
466210|NCT00831701|B3|Baseline|Total|Total of all reporting groups
466211|NCT00831701|B2|Baseline|Placebo Treatment|Patients received Placebo pill once daily
466212|NCT00831701|B1|Baseline|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466213|NCT00831701|P2|Participant Flow|Placebo Treatment|Patients received Placebo pill once daily
466214|NCT00831701|P1|Participant Flow|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466215|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
466216|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466217|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
466224|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466225|NCT00831701|E2|Reported Event|Placebo Treatment|Patients received Placebo pill once daily
466226|NCT00831701|E1|Reported Event|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
466227|NCT00831675|B3|Baseline|Total|Total of all reporting groups
466228|NCT00831675|B2|Baseline|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466229|NCT00831675|B1|Baseline|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466230|NCT00831675|P2|Participant Flow|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466231|NCT00831675|P1|Participant Flow|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466232|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466233|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466234|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466235|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466236|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466237|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466238|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466239|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466240|NCT00831675|E2|Reported Event|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466241|NCT00831675|E1|Reported Event|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
466242|NCT00831493|B1|Baseline|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
466243|NCT00831493|P1|Participant Flow|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
466244|NCT00831493|O1|Outcome|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
466245|NCT00831493|E1|Reported Event|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
466246|NCT00831480|B1|Baseline|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
466247|NCT00831480|P1|Participant Flow|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
466248|NCT00831480|O1|Outcome|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
466249|NCT00831480|E1|Reported Event|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
466250|NCT00831441|B3|Baseline|Total|Total of all reporting groups
466251|NCT00831441|B2|Baseline|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily.
466252|NCT00831441|B1|Baseline|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466253|NCT00831441|P2|Participant Flow|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
466254|NCT00831441|P1|Participant Flow|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
466255|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466256|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466257|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466258|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466259|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466260|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466261|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466262|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466263|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466264|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466265|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466266|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466267|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466268|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466269|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466270|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466271|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466272|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466273|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466274|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466275|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
466276|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466277|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated in Year 2.
466278|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
466279|NCT00831441|E2|Reported Event|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
466280|NCT00831441|E1|Reported Event|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
466281|NCT00831428|B1|Baseline|Scottish Swimming Team|
466282|NCT00831428|P1|Participant Flow|Scottish Swimming Team|
466283|NCT00831428|O1|Outcome|Scottish Swimming Team|
466284|NCT00831428|E1|Reported Event|Scottish Swimming Team|
466285|NCT00831415|B1|Baseline|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
466286|NCT00831415|P1|Participant Flow|DVS SR|Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.
466287|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
466288|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
466289|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
466290|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
466291|NCT00831415|E1|Reported Event|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
466292|NCT00831389|B3|Baseline|Total|Total of all reporting groups
466293|NCT00831389|B2|Baseline|First Standard of Care or Open Loop, Then CLosed Loop|First Standard of Care or Open Loop, Then CLosed Loop
466294|NCT00831389|B1|Baseline|First Closed Loop, Then Standard of Care or Open Loop|First Closed Loop, Then Standard of Care or Open Loop
466295|NCT00831389|P2|Participant Flow|First Closed Loop, Then Standard of Care or Open Loop|All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466296|NCT00831389|P1|Participant Flow|First Standard of Care or Open Loop, Then CLosed Loop|All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466355|NCT00831272|E2|Reported Event|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
466356|NCT00831272|E1|Reported Event|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
466297|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466298|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466299|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466300|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466301|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466302|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466303|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466304|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466305|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466306|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466307|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466308|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466309|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466310|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466311|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466312|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466313|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466314|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466315|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466316|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466317|NCT00831389|E2|Reported Event|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466318|NCT00831389|E1|Reported Event|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
466319|NCT00831311|B3|Baseline|Total|Total of all reporting groups
466320|NCT00831311|B2|Baseline|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466321|NCT00831311|B1|Baseline|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466322|NCT00831311|P2|Participant Flow|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466323|NCT00831311|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466324|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466325|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466326|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466327|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466328|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466329|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466330|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466331|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466332|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466333|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466334|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466335|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466336|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466337|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466338|NCT00831311|E2|Reported Event|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
466339|NCT00831311|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
466340|NCT00831272|B5|Baseline|Total|Total of all reporting groups
466341|NCT00831272|B4|Baseline|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
466342|NCT00831272|B3|Baseline|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
466343|NCT00831272|B2|Baseline|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
466344|NCT00831272|B1|Baseline|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
466345|NCT00831272|P4|Participant Flow|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
466346|NCT00831272|P3|Participant Flow|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
466347|NCT00831272|P2|Participant Flow|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
466348|NCT00831272|P1|Participant Flow|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
466349|NCT00831272|O4|Outcome|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
466350|NCT00831272|O3|Outcome|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
466351|NCT00831272|O2|Outcome|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
466352|NCT00831272|O1|Outcome|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
466353|NCT00831272|E4|Reported Event|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
466354|NCT00831272|E3|Reported Event|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
466357|NCT00831233|B3|Baseline|Total|Total of all reporting groups
466358|NCT00831233|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466359|NCT00831233|B1|Baseline|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466360|NCT00831233|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466361|NCT00831233|P1|Participant Flow|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466362|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466363|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466364|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466365|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466366|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466367|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466368|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466369|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466370|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466371|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466372|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466373|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466374|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466375|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466376|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466377|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466378|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466379|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466380|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466381|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466382|NCT00831233|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
466383|NCT00831233|E1|Reported Event|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
466384|NCT00831181|B1|Baseline|Chemoradiation,Surgery, Chemotherapy|Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6
466385|NCT00831181|P1|Participant Flow|Oxaliplatin/5-FU Followed by Mesorectal Excision and FOLFOX 6|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
466386|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
466387|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
466388|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
466389|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
466390|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
466391|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
467876|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
466392|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|"Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6:~Preoperative therapy: Oxaliplatin 60 mg/m2 weekly dosing during radiation with continuous infusion 5-FU 225 mg/m2/d Monday through Friday for a total of 96 hours per week each week of radiation (approximately 6-7 weeks). Radiation dose will be 50-54Gy with possible intraoperative (IORT) radiation (10-12Gy).~Surgery: Total Mesorectal Excision~Postoperative therapy: FOLFOX6 every 2 weeks for 6 cycles (3 months)"
466393|NCT00831181|O1|Outcome|Chemoradiation,Surgery, Chemotherapy|Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6
466394|NCT00831181|E1|Reported Event|Chemoradiation,Surgery, Chemotherapy|Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and FOLFOX 6
466395|NCT00831129|B3|Baseline|Total|Total of all reporting groups
466396|NCT00831129|B2|Baseline|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466397|NCT00831129|B1|Baseline|Placebo|simvastatin 40 mg/day plus placebo
466398|NCT00831129|P2|Participant Flow|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466399|NCT00831129|P1|Participant Flow|Placebo|simvastatin 40 mg/day plus placebo
466400|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466401|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466402|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466403|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466404|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466405|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466406|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466407|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466408|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466409|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466410|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466411|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466412|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466413|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466414|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466415|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466416|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466417|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466418|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466419|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466420|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466421|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466422|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466423|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466424|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466425|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466426|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466427|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466428|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466429|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466430|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466431|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
466432|NCT00831129|E2|Reported Event|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
466433|NCT00831129|E1|Reported Event|Placebo|simvastatin 40 mg/day plus placebo
466434|NCT00830960|B7|Baseline|Total|Total of all reporting groups
466435|NCT00830960|B6|Baseline|Clopidogrel 300/75 Low Weight/Elderly|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466436|NCT00830960|B5|Baseline|Prasugrel 30/5 Low Weight/Elderly|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466437|NCT00830960|B4|Baseline|Clopidogrel 300/75 Primary|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466438|NCT00830960|B3|Baseline|Prasugrel 30/5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466439|NCT00830960|B2|Baseline|Prasugrel 30/7.5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466440|NCT00830960|B1|Baseline|Prasugrel 60/10 Primary|"Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)~Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug."
466441|NCT00830960|P6|Participant Flow|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466442|NCT00830960|P5|Participant Flow|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466443|NCT00830960|P4|Participant Flow|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466604|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466444|NCT00830960|P3|Participant Flow|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466445|NCT00830960|P2|Participant Flow|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466446|NCT00830960|P1|Participant Flow|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466447|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466448|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466449|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466450|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466451|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466452|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466453|NCT00830960|O4|Outcome|Clopidogrel 300/75 PD|Population includes participants in genetics substudy who were randomly assigned to receive a clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
466454|NCT00830960|O3|Outcome|Prasugrel 30/5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
466455|NCT00830960|O2|Outcome|Prasugrel 30/7.5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
466456|NCT00830960|O1|Outcome|Prasugrel 60/10 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary Cohort.
466457|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466458|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466459|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466460|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466461|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466462|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466463|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466464|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466465|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466466|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466467|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466468|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466469|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466470|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466471|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466837|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466472|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466473|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466474|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466475|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466476|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466477|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466478|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466479|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466480|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466481|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466482|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466483|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466484|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466485|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466486|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466487|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466488|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466489|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466490|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466491|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466492|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466493|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466494|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466495|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466496|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466497|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466498|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466499|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466865|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466500|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466501|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466502|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466503|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466504|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466505|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466506|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466507|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466508|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466509|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466510|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466511|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466512|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466513|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466514|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466515|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466516|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466517|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants in primary cohort randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort participant weight ≥60 kg and age <75 years)
466518|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466519|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466520|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466521|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466522|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466523|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466524|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466525|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466526|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466527|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466528|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
466529|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466530|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466531|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466532|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466533|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a clopidogrel 300-mg LD.
466534|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a prasugrel 30-mg LD.
466535|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were treated with a clopidogrel 300-mg LD.
466536|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 30-mg LD(including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
466537|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 60-mg LD.
466538|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466539|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
466540|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466541|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466542|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466543|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
466544|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
466545|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
466546|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
466547|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
466548|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
466549|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
466550|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
466551|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
466552|NCT00830960|E7|Reported Event|Clopidogrel 300/75 No Weight|Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day
466553|NCT00830960|E6|Reported Event|Clopidogrel 300/75 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
466554|NCT00830960|E5|Reported Event|Prasugrel 30/5 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
466555|NCT00830960|E4|Reported Event|Clopidogrel 300/75 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
466556|NCT00830960|E3|Reported Event|Prasugrel 30/5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
466557|NCT00830960|E2|Reported Event|Prasugrel 30/7.5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day
466558|NCT00830960|E1|Reported Event|Prasugrel 60/10 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.
466559|NCT00830947|B3|Baseline|Total|Total of all reporting groups
466560|NCT00830947|B2|Baseline|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
466561|NCT00830947|B1|Baseline|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
466562|NCT00830947|P2|Participant Flow|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
466563|NCT00830947|P1|Participant Flow|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
466564|NCT00830947|O2|Outcome|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
466565|NCT00830947|O1|Outcome|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
466566|NCT00830947|E2|Reported Event|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
466567|NCT00830947|E1|Reported Event|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
466568|NCT00830804|B1|Baseline|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466569|NCT00830804|P1|Participant Flow|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466570|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466571|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466572|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466573|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466574|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466575|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466576|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466577|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466578|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466579|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466580|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466581|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466582|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466583|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466584|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466585|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466586|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466587|NCT00830804|E1|Reported Event|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
466588|NCT00830791|B7|Baseline|Total|Total of all reporting groups
466589|NCT00830791|B6|Baseline|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
466590|NCT00830791|B5|Baseline|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
466591|NCT00830791|B4|Baseline|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466592|NCT00830791|B3|Baseline|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
466593|NCT00830791|B2|Baseline|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466594|NCT00830791|B1|Baseline|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
466595|NCT00830791|P6|Participant Flow|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
466596|NCT00830791|P5|Participant Flow|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
466597|NCT00830791|P4|Participant Flow|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466598|NCT00830791|P3|Participant Flow|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
466599|NCT00830791|P2|Participant Flow|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466600|NCT00830791|P1|Participant Flow|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
466601|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg.
466602|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
466603|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
466605|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
466606|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466607|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
466608|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
466609|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
466610|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466611|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
466612|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466613|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose of 10 mg x 2.
466614|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
466615|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466616|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466617|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466618|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466619|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
466620|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
466621|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466622|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466623|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466624|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466625|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
466626|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
466627|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466628|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466629|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466630|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466631|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
466632|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
466633|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466634|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466635|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
466636|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
466637|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466638|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466639|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466640|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466641|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466642|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
466643|NCT00830791|E3|Reported Event|MK-0941 20 mg and Moderate Renal Insufficiency|MK-0941 was administered as a single oral dose of 20 mg to participants with moderate renal insufficiency.
466644|NCT00830791|E2|Reported Event|MK-0941 20 mg and Mild Renal Insufficiency|MK-0941 was administered as a single oral dose to participants with mild renal insufficiency.
466645|NCT00830791|E1|Reported Event|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
466646|NCT00830765|B3|Baseline|Total|Total of all reporting groups
466647|NCT00830765|B2|Baseline|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
466648|NCT00830765|B1|Baseline|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
466649|NCT00830765|P2|Participant Flow|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
466650|NCT00830765|P1|Participant Flow|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
466651|NCT00830765|O2|Outcome|Placebo Group|Progesterone injection was compared to placebo injection on a weekly basis.
466652|NCT00830765|O1|Outcome|Progesterone Group|Progesterone injection was compared to placebo injection on a weekly basis.
466653|NCT00830765|E2|Reported Event|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
466654|NCT00830765|E1|Reported Event|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
466655|NCT00830596|B4|Baseline|Total|Total of all reporting groups
466656|NCT00830596|B3|Baseline|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466657|NCT00830596|B2|Baseline|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466658|NCT00830596|B1|Baseline|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466659|NCT00830596|P3|Participant Flow|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466660|NCT00830596|P2|Participant Flow|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466661|NCT00830596|P1|Participant Flow|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466662|NCT00830596|O3|Outcome|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466663|NCT00830596|O2|Outcome|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466664|NCT00830596|O1|Outcome|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466665|NCT00830596|O3|Outcome|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466666|NCT00830596|O2|Outcome|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466667|NCT00830596|O1|Outcome|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466668|NCT00830596|O3|Outcome|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466669|NCT00830596|O2|Outcome|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466670|NCT00830596|O1|Outcome|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466671|NCT00830596|O3|Outcome|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466672|NCT00830596|O2|Outcome|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466673|NCT00830596|O1|Outcome|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466674|NCT00830596|O3|Outcome|Sham Intervention|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466675|NCT00830596|O2|Outcome|LVVA-SM|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466925|NCT00830024|B3|Baseline|Total|Total of all reporting groups
466676|NCT00830596|O1|Outcome|HVLA-SM|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466677|NCT00830596|E3|Reported Event|Sham Intervention*|"Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks~light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation"
466678|NCT00830596|E2|Reported Event|LVVA-SM*|"Low velocity, variable amplitude lumbo-pelvic manipulation~LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation"
466679|NCT00830596|E1|Reported Event|HVLA-SM*|"High velocity, low amplitude lumbo-pelvic manipulation~HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation"
466680|NCT00830518|B3|Baseline|Total|Total of all reporting groups
466681|NCT00830518|B2|Baseline|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466682|NCT00830518|B1|Baseline|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466683|NCT00830518|P2|Participant Flow|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466684|NCT00830518|P1|Participant Flow|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466685|NCT00830518|O2|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466686|NCT00830518|O1|Outcome|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466687|NCT00830518|O2|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466688|NCT00830518|O1|Outcome|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466689|NCT00830518|O2|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466690|NCT00830518|O1|Outcome|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466691|NCT00830518|O1|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466692|NCT00830518|O2|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466693|NCT00830518|O1|Outcome|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466694|NCT00830518|O2|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466695|NCT00830518|O1|Outcome|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466696|NCT00830518|O2|Outcome|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466697|NCT00830518|O1|Outcome|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466698|NCT00830518|E2|Reported Event|Alisertib 50 mg (Myelodysplastic Syndrome)|Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 6 Cycles).
466699|NCT00830518|E1|Reported Event|Alisertib 50 mg (Acute Myeloid Leukemia)|Participants with acute myeloid leukemia received alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
466700|NCT00830440|B3|Baseline|Total|Total of all reporting groups
466701|NCT00830440|B2|Baseline|Control: (Diet and Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
466702|NCT00830440|B1|Baseline|EndoBarrier and Diet/Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
466703|NCT00830440|P2|Participant Flow|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
466704|NCT00830440|P1|Participant Flow|EndoBarrier Device|"EndoBarrier + Diet + Lifestyle counseling 12 Week implant duration~EndoBarrier: Monthly visits"
466705|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
466706|NCT00830440|O1|Outcome|EndoBarrier/Diet and Lifestyle Counseling/12 Weeks|12 week implantation period
466707|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
466708|NCT00830440|O1|Outcome|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
466709|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
466710|NCT00830440|O1|Outcome|EndoBarrier/Diet and Lifestyle Counseling/12 Weeks|12 week implantation period
466711|NCT00830440|E2|Reported Event|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
466712|NCT00830440|E1|Reported Event|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
466713|NCT00830388|B1|Baseline|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
466714|NCT00830388|P1|Participant Flow|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
466715|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
466716|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
466717|NCT00830388|E1|Reported Event|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
466718|NCT00830375|B1|Baseline|Memantine|10-30mg tablets of memantine taken once daily by mouth
466719|NCT00830375|P1|Participant Flow|Memantine|10-30mg tablets of memantine taken once daily by mouth
466720|NCT00830375|O1|Outcome|Memantine|10-30mg tablets of memantine taken once daily by mouth
466721|NCT00830375|E1|Reported Event|Memantine|10-30mg tablets of memantine taken once daily by mouth
466722|NCT00830362|B3|Baseline|Total|Total of all reporting groups
466723|NCT00830362|B2|Baseline|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
466724|NCT00830362|B1|Baseline|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
466725|NCT00830362|P2|Participant Flow|Placebo|Placebo : administered once. The subjects whose data we analyzed upon study completion who received placebo were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
466726|NCT00830362|P1|Participant Flow|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects whose data we analyzed upon study completion who received propranolol were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
466727|NCT00830362|O2|Outcome|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
466728|NCT00830362|O1|Outcome|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
466729|NCT00830362|E2|Reported Event|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
466730|NCT00830362|E1|Reported Event|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
466731|NCT00830336|B3|Baseline|Total|Total of all reporting groups
466732|NCT00830336|B2|Baseline|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
466733|NCT00830336|B1|Baseline|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
466734|NCT00830336|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
466735|NCT00830336|P1|Participant Flow|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
466736|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
466737|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
466738|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
466739|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
466740|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
466741|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
466926|NCT00830024|B2|Baseline|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
466742|NCT00830310|B1|Baseline|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466743|NCT00830310|P1|Participant Flow|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466744|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466745|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466746|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466747|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466748|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466749|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466750|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
468603|NCT00824993|B2|Baseline|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
466751|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466752|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466753|NCT00830310|E1|Reported Event|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
466754|NCT00830284|B1|Baseline|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
466755|NCT00830284|P1|Participant Flow|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
466756|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
466757|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
466758|NCT00830284|E1|Reported Event|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
466759|NCT00830258|B3|Baseline|Total|Total of all reporting groups
466760|NCT00830258|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
466761|NCT00830258|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
466762|NCT00830258|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
466763|NCT00830258|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
466764|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
466765|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
466766|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
466767|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
466768|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
466769|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
466770|NCT00830232|B3|Baseline|Total|Total of all reporting groups
466771|NCT00830232|B2|Baseline|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
466772|NCT00830232|B1|Baseline|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
466773|NCT00830232|P2|Participant Flow|Open-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent.~Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device."
466927|NCT00830024|B1|Baseline|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
466774|NCT00830232|P1|Participant Flow|Closed-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this group was the Xact closed-cell stent. This type of device is a rigid device with a dense composition between the nitinol rings.~Carotid stenting was used on standard fashion using filters as embolic protection device."
466775|NCT00830232|O2|Outcome|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
466776|NCT00830232|O1|Outcome|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
466777|NCT00830232|E2|Reported Event|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
466778|NCT00830232|E1|Reported Event|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
466779|NCT00830219|B3|Baseline|Total|Total of all reporting groups
466780|NCT00830219|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
466781|NCT00830219|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
466782|NCT00830219|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
466783|NCT00830219|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
466784|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
466785|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
466786|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
466787|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
466788|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
466789|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
466790|NCT00830206|B3|Baseline|Total|Total of all reporting groups
466791|NCT00830206|B2|Baseline|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
466792|NCT00830206|B1|Baseline|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
466793|NCT00830206|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
466794|NCT00830206|P1|Participant Flow|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
466795|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
466796|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
466797|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
466798|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
466799|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
466800|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
466801|NCT00830167|B3|Baseline|Total|Total of all reporting groups
466802|NCT00830167|B2|Baseline|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466803|NCT00830167|B1|Baseline|Placebo|Placebo was administered twice a day for 15 weeks.
466804|NCT00830167|P2|Participant Flow|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466805|NCT00830167|P1|Participant Flow|Placebo|Placebo was administered twice a day for 15 weeks.
466806|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466807|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466808|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466809|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466928|NCT00830024|P2|Participant Flow|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
467028|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
466810|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466811|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466812|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466813|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466814|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466815|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466816|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466817|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466818|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466819|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466820|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466821|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466822|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466823|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466824|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466825|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466826|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466827|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466828|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466829|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466830|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466831|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466832|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466833|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466834|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466835|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466836|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466992|NCT00829829|B4|Baseline|Total|Total of all reporting groups
466838|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466839|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466840|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466841|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466842|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466843|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466844|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466845|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466846|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466847|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466848|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466849|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466850|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466851|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466852|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466853|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466854|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466855|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466856|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466857|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466858|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466859|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466860|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466861|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466862|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466863|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466864|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
469080|NCT00824382|E1|Reported Event|Placebo|Placebo
466866|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466867|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466868|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466869|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466870|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466871|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
466872|NCT00830167|E2|Reported Event|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
466873|NCT00830167|E1|Reported Event|Placebo|Placebo was administered twice a day for 15 weeks.
466874|NCT00830128|B1|Baseline|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466875|NCT00830128|P1|Participant Flow|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466876|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466877|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466878|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466879|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466880|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466881|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466882|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466883|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466884|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466885|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466886|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
467026|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
466887|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466888|NCT00830128|E1|Reported Event|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
466889|NCT00830115|B1|Baseline|Pantoprazole|All patients enrolled
466890|NCT00830115|P1|Participant Flow|Pantoprazole|All patients enrolled
466891|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
466892|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
466893|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
466894|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
466895|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
466896|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
466897|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
466898|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
466899|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
466900|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
466901|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
466902|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
466903|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
466904|NCT00830115|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
466905|NCT00830076|B1|Baseline|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
466906|NCT00830076|P1|Participant Flow|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
466907|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
466908|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
466909|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
466910|NCT00830076|E4|Reported Event|Placebo Sitagliptin + Placebo Metformin|Participants received placebo sitagliptin + placebo metformin for 2 days.
466911|NCT00830076|E3|Reported Event|Sitagliptin + Metformin|Participants received co-administration of sitagliptin + metformin for 2 days.
466912|NCT00830076|E2|Reported Event|Metformin + Placebo Sitagliptin|Participants received metformin + placebo sitagliptin for 2 days.
466913|NCT00830076|E1|Reported Event|Sitagliptin + Placebo Metformin|Participants received sitagliptin + placebo metformin for 2 days.
466914|NCT00830037|B3|Baseline|Total|Total of all reporting groups
466915|NCT00830037|B2|Baseline|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
466916|NCT00830037|B1|Baseline|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
466917|NCT00830037|P2|Participant Flow|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
466918|NCT00830037|P1|Participant Flow|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
466919|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
466920|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
466921|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
466922|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
466923|NCT00830037|E2|Reported Event|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
466924|NCT00830037|E1|Reported Event|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
466929|NCT00830024|P1|Participant Flow|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
466930|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
466931|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
466932|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
466933|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
466934|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
466935|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
466936|NCT00829998|B3|Baseline|Total|Total of all reporting groups
466937|NCT00829998|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
466938|NCT00829998|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
466939|NCT00829998|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
466940|NCT00829998|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
466941|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
466942|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
466943|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
466944|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
466945|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
466946|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
466947|NCT00829985|B3|Baseline|Total|Total of all reporting groups
466948|NCT00829985|B2|Baseline|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
466949|NCT00829985|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466950|NCT00829985|P2|Participant Flow|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
466951|NCT00829985|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466952|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
466953|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466954|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
466955|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466956|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
467027|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
466957|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466958|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
466959|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466960|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
466961|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466962|NCT00829985|E2|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
466963|NCT00829985|E1|Reported Event|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
466964|NCT00829933|B5|Baseline|Total|Total of all reporting groups
466965|NCT00829933|B4|Baseline|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
466966|NCT00829933|B3|Baseline|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
466967|NCT00829933|B2|Baseline|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
466968|NCT00829933|B1|Baseline|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
466969|NCT00829933|P4|Participant Flow|Warfarin|"Warfarin potassium tablets:~Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose"
466970|NCT00829933|P3|Participant Flow|DU-176b High Dose 60mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
466971|NCT00829933|P2|Participant Flow|DU-176b Intermediate Dose 45mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
466972|NCT00829933|P1|Participant Flow|DU-176b Low Dose 30mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
466973|NCT00829933|O4|Outcome|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
466974|NCT00829933|O3|Outcome|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
466975|NCT00829933|O2|Outcome|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
466976|NCT00829933|O1|Outcome|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
466977|NCT00829933|E4|Reported Event|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
466978|NCT00829933|E3|Reported Event|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
466979|NCT00829933|E2|Reported Event|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
466980|NCT00829933|E1|Reported Event|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
466981|NCT00829868|B3|Baseline|Total|Total of all reporting groups
466982|NCT00829868|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
466983|NCT00829868|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
466984|NCT00829868|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
466985|NCT00829868|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
466986|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
466987|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
466988|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
466989|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
466990|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
466991|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
466993|NCT00829829|B3|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
466994|NCT00829829|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
466995|NCT00829829|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
466996|NCT00829829|P3|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
466997|NCT00829829|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
466998|NCT00829829|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
466999|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
467000|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
467001|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
467002|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
467003|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
467004|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
467005|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
467006|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
467007|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
467008|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
467009|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
467010|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
467011|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
467012|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
467013|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
467014|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
467015|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
467016|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
467017|NCT00829829|E3|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
467018|NCT00829829|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
467019|NCT00829829|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
467020|NCT00829790|B3|Baseline|Total|Total of all reporting groups
467021|NCT00829790|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
467022|NCT00829790|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
467023|NCT00829790|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
467024|NCT00829790|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
467025|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
467029|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
467030|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
467031|NCT00829764|B3|Baseline|Total|Total of all reporting groups
467032|NCT00829764|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
467033|NCT00829764|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
467034|NCT00829764|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
467035|NCT00829764|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
467036|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
467037|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
467038|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
467039|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
467040|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
467041|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
467042|NCT00829738|B1|Baseline|Pantoprazole|All patients enrolled
467043|NCT00829738|P1|Participant Flow|Pantoprazole|All patients enrolled
467044|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
467045|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
467046|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467047|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467048|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467049|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
467050|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467051|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467052|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467053|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
467054|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467055|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467056|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
467057|NCT00829738|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
467058|NCT00829712|B3|Baseline|Total|Total of all reporting groups
467059|NCT00829712|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
467060|NCT00829712|B1|Baseline|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
467061|NCT00829712|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
467062|NCT00829712|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
467063|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
467064|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
467065|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
467066|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
467067|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
467068|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
467069|NCT00829686|B3|Baseline|Total|Total of all reporting groups
467070|NCT00829686|B2|Baseline|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
467071|NCT00829686|B1|Baseline|No Intervention|No antibiotic
467072|NCT00829686|P2|Participant Flow|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
467073|NCT00829686|P1|Participant Flow|No Intervention|No antibiotic
467074|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
467075|NCT00829686|O1|Outcome|No Intervention|No antibiotic
467076|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
467077|NCT00829686|O1|Outcome|No Intervention|No antibiotic
467078|NCT00829673|B3|Baseline|Total|Total of all reporting groups
467079|NCT00829673|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
467186|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
467080|NCT00829673|B1|Baseline|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
467081|NCT00829673|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
467082|NCT00829673|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
467083|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
467084|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
467085|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
467086|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
467087|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
467088|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
467089|NCT00829621|B3|Baseline|Total|Total of all reporting groups
467090|NCT00829621|B2|Baseline|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
467091|NCT00829621|B1|Baseline|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
467092|NCT00829621|P2|Participant Flow|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
467093|NCT00829621|P1|Participant Flow|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
467094|NCT00829621|O2|Outcome|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
467095|NCT00829621|O1|Outcome|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
467096|NCT00829621|E2|Reported Event|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
467097|NCT00829621|E1|Reported Event|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
467098|NCT00829530|B3|Baseline|Total|Total of all reporting groups
467099|NCT00829530|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
467100|NCT00829530|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
467101|NCT00829530|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
467102|NCT00829530|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
467103|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467104|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467105|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467106|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467107|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467108|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467109|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467110|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467111|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467112|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467113|NCT00829504|B3|Baseline|Total|Total of all reporting groups
467114|NCT00829504|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
467115|NCT00829504|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
467116|NCT00829504|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
467117|NCT00829504|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
467118|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
467119|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
467120|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
467121|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
467122|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
467123|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
467124|NCT00829452|B3|Baseline|Total|Total of all reporting groups
467187|NCT00829296|B3|Baseline|Total|Total of all reporting groups
467125|NCT00829452|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
467126|NCT00829452|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
467127|NCT00829452|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
467128|NCT00829452|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
467129|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467130|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467131|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467132|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467133|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467134|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467135|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467136|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467137|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467138|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467139|NCT00829439|B1|Baseline|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
467140|NCT00829439|P4|Participant Flow|Levodopa / Carbidopa 15 mg/kg/Day|Levodopa / Carbidopa 15 mg/kg/day in 3 divided doses
467141|NCT00829439|P3|Participant Flow|Levodopa / Carbidopa 10 mg/kg/Day|Levodopa 10 mg/kg/day in 3 divided doses
467142|NCT00829439|P2|Participant Flow|Levodopa / Carbidopa 5 mg/kg/Day|Levodopa 5 mg/kg/day in 3 divided doses
467143|NCT00829439|P1|Participant Flow|Levodopa/Carbidopa 2 mg/kg/Day|Levodopa at 2 mg/kg/day in 3 divided doses
467144|NCT00829439|O1|Outcome|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
467145|NCT00829439|E1|Reported Event|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
467146|NCT00829426|B3|Baseline|Total|Total of all reporting groups
467147|NCT00829426|B2|Baseline|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
467148|NCT00829426|B1|Baseline|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
467149|NCT00829426|P2|Participant Flow|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
467150|NCT00829426|P1|Participant Flow|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
467151|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
467152|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
467153|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
467154|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
467155|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
467156|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
467157|NCT00829387|B3|Baseline|Total|Total of all reporting groups
467158|NCT00829387|B2|Baseline|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467188|NCT00829296|B2|Baseline|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
467159|NCT00829387|B1|Baseline|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467160|NCT00829387|P2|Participant Flow|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467161|NCT00829387|P1|Participant Flow|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467162|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467163|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467164|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467165|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467166|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467167|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467168|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467169|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467170|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467171|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467172|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467173|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467174|NCT00829387|E2|Reported Event|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
467175|NCT00829387|E1|Reported Event|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
467176|NCT00829309|B3|Baseline|Total|Total of all reporting groups
467177|NCT00829309|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
467178|NCT00829309|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
467179|NCT00829309|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
467180|NCT00829309|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
467181|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
467182|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
467183|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
467184|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
467185|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
467189|NCT00829296|B1|Baseline|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
467190|NCT00829296|P2|Participant Flow|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
467191|NCT00829296|P1|Participant Flow|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
467192|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
467193|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
467194|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
467195|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
467196|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
467197|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
467198|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
467199|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
467200|NCT00829296|E2|Reported Event|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
467201|NCT00829296|E1|Reported Event|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
467202|NCT00829283|B3|Baseline|Total|Total of all reporting groups
467203|NCT00829283|B2|Baseline|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
467204|NCT00829283|B1|Baseline|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
467205|NCT00829283|P2|Participant Flow|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
467206|NCT00829283|P1|Participant Flow|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
467207|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
467208|NCT00829283|O1|Outcome|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
467209|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
467210|NCT00829283|O1|Outcome|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
467211|NCT00829283|E2|Reported Event|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
467212|NCT00829283|E1|Reported Event|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
467213|NCT00829244|B3|Baseline|Total|Total of all reporting groups
467214|NCT00829244|B2|Baseline|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
467215|NCT00829244|B1|Baseline|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467216|NCT00829244|P2|Participant Flow|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
467217|NCT00829244|P1|Participant Flow|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467218|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467219|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467220|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467628|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
469081|NCT00824369|B7|Baseline|Total|Total of all reporting groups
467221|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467222|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467223|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467224|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467225|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467226|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467227|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467228|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467229|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467230|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467231|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467232|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467233|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467234|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467235|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467236|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467237|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467238|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467239|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467240|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467629|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467241|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467242|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
467243|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467244|NCT00829244|E2|Reported Event|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
467245|NCT00829244|E1|Reported Event|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
467246|NCT00829179|B1|Baseline|RhuMab-E25|
467247|NCT00829179|P1|Participant Flow|RhuMab-E25|"Subjects with mild asthma received three doses of study drug subcutaneous injections at one month intervals. Dosing range was 150mg-375mg which was based on baseline IGE and subject body weight.~Subjects with a baseline Ige above 30 and up to 100 with a body weight between 30 and 150kg would receive a study drug dose of 150 mg. Subjects with an IGE 100-200 and body weight 30 - 150 kg would receive a dose of 225 mg. And up to subjects with an IGE of 600-700 only body weight of 30 - 60 would be included with a dose of 375 mg."
467248|NCT00829179|O1|Outcome|RhuMab-E25|
467249|NCT00829179|E1|Reported Event|RhuMab-E25|
467250|NCT00829166|B3|Baseline|Total|Total of all reporting groups
467251|NCT00829166|B2|Baseline|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467252|NCT00829166|B1|Baseline|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467253|NCT00829166|P2|Participant Flow|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467254|NCT00829166|P1|Participant Flow|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
467255|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467256|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467257|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467258|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467259|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467260|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467261|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
469940|NCT00822328|B3|Baseline|Total|Total of all reporting groups
467262|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467263|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467264|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467265|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467266|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467267|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467268|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467269|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467270|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467271|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467272|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467273|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467274|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467275|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467276|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467277|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467278|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467279|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467630|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467280|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467281|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467282|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467283|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467284|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467285|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467286|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467287|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467288|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467289|NCT00829166|E3|Reported Event|Lapatinib + Capecitabine/ Trastuzumab Emtansine|"Participants of Lapatinib + Capecitabine arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis."
467290|NCT00829166|E2|Reported Event|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
467291|NCT00829166|E1|Reported Event|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
467292|NCT00829049|B3|Baseline|Total|Total of all reporting groups
467293|NCT00829049|B2|Baseline|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
467294|NCT00829049|B1|Baseline|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
467295|NCT00829049|P2|Participant Flow|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
467296|NCT00829049|P1|Participant Flow|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
467297|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
467298|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
467299|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
467300|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
467301|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
467302|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
467303|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
467304|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
467305|NCT00829049|E2|Reported Event|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
467306|NCT00829049|E1|Reported Event|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
467307|NCT00829036|B1|Baseline|Baseline Wayfinding Performance|An Orientation and Mobility specialist teaches subjects (1) how to find each of 4 specific locations in an open space from a random starting location, and (2) how to navigate hallways from a known starting location to find each of 8 specific locations in the hallways of the Atlanta VA Medical Center. Subjects are then (1) brought to a random start point in the open space and asked to walk to the same 4 specific locations they were taught to find and (2) brought to a known starting point in the hallways of the VA Medical Center and asked to walk to the same 8 specific locations they were taught to find.
467494|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467495|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467308|NCT00829036|P1|Participant Flow|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
467309|NCT00829036|O1|Outcome|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
467310|NCT00829036|E1|Reported Event|Wayfinding: Prototype vs. Baseline|"Prototype:~Subjects are trained to use the prototype to walk to selected destinations (1) in open spaces and (2) through hallways. Then, over 12 trials, subjects are asked to use the prototype to walk to a different unknown location in each trial. Half the locations are in open spaces and half in hallways. Performance time is measured.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subjects how to find (walk to) 12 specific locations, 6 in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations. Performance time is measured."
467311|NCT00829010|B6|Baseline|Total|Total of all reporting groups
467312|NCT00829010|B5|Baseline|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467313|NCT00829010|B4|Baseline|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467314|NCT00829010|B3|Baseline|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467315|NCT00829010|B2|Baseline|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467316|NCT00829010|B1|Baseline|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467317|NCT00829010|P5|Participant Flow|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467318|NCT00829010|P4|Participant Flow|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467319|NCT00829010|P3|Participant Flow|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467320|NCT00829010|P2|Participant Flow|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467321|NCT00829010|P1|Participant Flow|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467322|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467323|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467496|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467631|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467324|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467325|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467326|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467327|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467328|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467329|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467330|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467497|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467498|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467331|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467332|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467333|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467334|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467335|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467336|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467337|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467499|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467632|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
471417|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
467338|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467339|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467340|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467341|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467342|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467343|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467344|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467500|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467501|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467345|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467346|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467347|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467348|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467349|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467350|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467351|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467502|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467633|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
471418|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
467352|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467353|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467354|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467355|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467356|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467357|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467358|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467503|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467504|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
471419|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
467359|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467360|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467361|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467362|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467363|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467364|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467365|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467505|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467634|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
471420|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
467366|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467367|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467368|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467369|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467370|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467371|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467372|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467506|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467507|NCT00828984|E3|Reported Event|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467373|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467374|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467375|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467376|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467377|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467378|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467379|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467508|NCT00828984|E2|Reported Event|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467635|NCT00828464|E1|Reported Event|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
468791|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
467380|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467381|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467382|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467383|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467384|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467385|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467386|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467509|NCT00828984|E1|Reported Event|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467510|NCT00828945|B1|Baseline|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467387|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467388|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467389|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467390|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467391|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467392|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467393|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467511|NCT00828945|P1|Participant Flow|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467512|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467513|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467394|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467395|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467396|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467397|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467398|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467399|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467400|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467514|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467515|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467682|NCT00828295|P2|Participant Flow|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
467401|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467402|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467403|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467404|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467405|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467406|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467407|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467516|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467517|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467683|NCT00828295|P1|Participant Flow|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
467408|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467409|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467410|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467411|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467412|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467413|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467414|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467518|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467519|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467520|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467415|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467416|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467417|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467418|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467419|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467420|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467421|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467521|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467522|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467684|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
467422|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467423|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467424|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467425|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467426|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467427|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467428|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467523|NCT00828945|E1|Reported Event|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
467524|NCT00828841|B4|Baseline|Total|Total of all reporting groups
467636|NCT00828451|B1|Baseline|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
467429|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467430|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467431|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467432|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467433|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467434|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467435|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467542|NCT00828750|B1|Baseline|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467714|NCT00828191|P1|Participant Flow|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
467436|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467437|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467438|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467439|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467440|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467441|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467442|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467543|NCT00828750|P1|Participant Flow|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467715|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
467443|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467444|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467445|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467446|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467447|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467448|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467449|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467544|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467680|NCT00828295|B2|Baseline|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
467450|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467451|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467452|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467453|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467454|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467455|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467456|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467545|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467716|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
467457|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467458|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467459|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467460|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467461|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467462|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467463|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467546|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467681|NCT00828295|B1|Baseline|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
467464|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467465|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467466|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467467|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467468|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467469|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467470|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467547|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467717|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
467471|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467472|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467473|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467474|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467475|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467476|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467477|NCT00829010|E5|Reported Event|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467548|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467718|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
467478|NCT00829010|E4|Reported Event|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467479|NCT00829010|E3|Reported Event|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467480|NCT00829010|E2|Reported Event|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467481|NCT00829010|E1|Reported Event|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
467482|NCT00828984|B4|Baseline|Total|Total of all reporting groups
467483|NCT00828984|B3|Baseline|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467484|NCT00828984|B2|Baseline|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467485|NCT00828984|B1|Baseline|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467486|NCT00828984|P3|Participant Flow|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467487|NCT00828984|P2|Participant Flow|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467488|NCT00828984|P1|Participant Flow|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467489|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467490|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467491|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467492|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467493|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
467719|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
467525|NCT00828841|B3|Baseline|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467526|NCT00828841|B2|Baseline|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467527|NCT00828841|B1|Baseline|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467528|NCT00828841|P3|Participant Flow|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467529|NCT00828841|P2|Participant Flow|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467530|NCT00828841|P1|Participant Flow|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467531|NCT00828841|O2|Outcome|Non-squamous Cell Histology|Subjects who were identified as having non-squamous cell histology, prior to randomization to a treatment arm.
467532|NCT00828841|O1|Outcome|Squamous Cell Histology|Subjects who were identified as having squamous cell histology, prior to randomization to a treatment arm.
467533|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467549|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467720|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
467534|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467535|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467536|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467537|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467538|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467539|NCT00828841|E3|Reported Event|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467540|NCT00828841|E2|Reported Event|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467541|NCT00828841|E1|Reported Event|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
467550|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467551|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467552|NCT00828750|E1|Reported Event|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
467553|NCT00828711|B4|Baseline|Total|Total of all reporting groups
467554|NCT00828711|B3|Baseline|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467555|NCT00828711|B2|Baseline|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467556|NCT00828711|B1|Baseline|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467557|NCT00828711|P3|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467558|NCT00828711|P2|Participant Flow|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467559|NCT00828711|P1|Participant Flow|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467560|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467561|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467562|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467563|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467564|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467565|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467566|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467567|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467627|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467568|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467569|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467570|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467571|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467572|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467573|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467574|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467575|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467576|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467577|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467578|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467579|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467580|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467581|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467582|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467583|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467584|NCT00828711|E3|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467585|NCT00828711|E2|Reported Event|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467586|NCT00828711|E1|Reported Event|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
467587|NCT00828568|B4|Baseline|Total|Total of all reporting groups
467588|NCT00828568|B3|Baseline|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
467589|NCT00828568|B2|Baseline|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
467590|NCT00828568|B1|Baseline|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
467591|NCT00828568|P3|Participant Flow|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
467592|NCT00828568|P2|Participant Flow|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
467593|NCT00828568|P1|Participant Flow|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
467594|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
467595|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
467596|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
467597|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod vehicle for 16 weeks
467598|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
467599|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
467600|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
467601|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
467602|NCT00828568|E3|Reported Event|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
467603|NCT00828568|E2|Reported Event|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
467604|NCT00828568|E1|Reported Event|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
467605|NCT00828542|B3|Baseline|Total|Total of all reporting groups
467606|NCT00828542|B2|Baseline|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of DMPA (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
467607|NCT00828542|B1|Baseline|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
467608|NCT00828542|P2|Participant Flow|Depot Medroxyprogesterone Acetate|Women randomized to depot medroxyprogesterone acetate group had at the 6th week postpartum, 150 mg of depot medroxyprogesterone acetate intramuscular (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil). A new injection was applied every 90 days if the patient wished to keep using the method.
467609|NCT00828542|P1|Participant Flow|Etonogestrel Implant|Immediately after giving birth, women randomized to etonogestrel implant group had an Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is a long-acting reversible contraceptive method, compounded by 68mg of etonogestrel, 3years of duration.
467610|NCT00828542|O2|Outcome|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil)
467611|NCT00828542|O1|Outcome|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
467612|NCT00828542|E2|Reported Event|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
467613|NCT00828542|E1|Reported Event|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
467614|NCT00828516|B1|Baseline|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
467615|NCT00828516|P1|Participant Flow|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
467616|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
467617|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
467618|NCT00828516|E1|Reported Event|Usual Care Plus Traditional Acupuncture|
467619|NCT00828464|B1|Baseline|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467620|NCT00828464|P1|Participant Flow|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467621|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467622|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467623|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467624|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467625|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
467626|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
471421|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
467637|NCT00828451|P1|Participant Flow|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
467638|NCT00828451|O1|Outcome|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
467639|NCT00828451|O1|Outcome|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
467640|NCT00828451|O1|Outcome|Preterm Infants for EGF Profiles|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
467641|NCT00828451|E1|Reported Event|Preterm Infants for EGF Profile|Premature infants born at < 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of [5,5,5-2H3]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.
467642|NCT00828412|B3|Baseline|Total|Total of all reporting groups
467643|NCT00828412|B2|Baseline|Desonide Cream 0.05%|Desonide Cream 0.05%
467644|NCT00828412|B1|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
467645|NCT00828412|P2|Participant Flow|Desonide Cream 0.05%|Desonide Cream 0.05% topically twice daily
467646|NCT00828412|P1|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion topically twice daily
467647|NCT00828412|O2|Outcome|Desonide Cream 0.05%|Week 6 Desonide Cream 0.05%
467648|NCT00828412|O1|Outcome|EpiCeram Skin Barrier Emulsion|Week 6 EpiCeram Skin Barrier Emulsion
467649|NCT00828412|E2|Reported Event|Desonide Cream 0.05%|Desonide Cream 0.05%
467650|NCT00828412|E1|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
467651|NCT00828347|B3|Baseline|Total|Total of all reporting groups
467652|NCT00828347|B2|Baseline|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467653|NCT00828347|B1|Baseline|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467654|NCT00828347|P2|Participant Flow|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467655|NCT00828347|P1|Participant Flow|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467656|NCT00828347|O2|Outcome|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467657|NCT00828347|O1|Outcome|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467658|NCT00828347|E2|Reported Event|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467659|NCT00828347|E1|Reported Event|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
467660|NCT00828321|B3|Baseline|Total|Total of all reporting groups
467661|NCT00828321|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
467662|NCT00828321|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
467663|NCT00828321|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
467664|NCT00828321|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
467665|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467666|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467667|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467668|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467669|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467670|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467671|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467672|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467673|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
467674|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
467675|NCT00828308|B1|Baseline|Ixabepilone|Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study)
467676|NCT00828308|P1|Participant Flow|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy.
467677|NCT00828308|O1|Outcome|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
467678|NCT00828308|E1|Reported Event|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
467679|NCT00828295|B3|Baseline|Total|Total of all reporting groups
472093|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
467685|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
467686|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
467687|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
467688|NCT00828295|E2|Reported Event|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
467689|NCT00828295|E1|Reported Event|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
467690|NCT00828204|B3|Baseline|Total|Total of all reporting groups
467691|NCT00828204|B2|Baseline|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467692|NCT00828204|B1|Baseline|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467693|NCT00828204|P2|Participant Flow|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467694|NCT00828204|P1|Participant Flow|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467695|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467696|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467697|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467698|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467699|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467721|NCT00828191|E2|Reported Event|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
467722|NCT00828191|E1|Reported Event|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
467700|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467701|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467702|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467703|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467704|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467705|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467706|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467707|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467708|NCT00828204|E2|Reported Event|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
467709|NCT00828204|E1|Reported Event|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
467710|NCT00828191|B3|Baseline|Total|Total of all reporting groups
467711|NCT00828191|B2|Baseline|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
467712|NCT00828191|B1|Baseline|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
467713|NCT00828191|P2|Participant Flow|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
467723|NCT00828178|B3|Baseline|Total|Total of all reporting groups
467725|NCT00828178|B1|Baseline|Fish Oil|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
467726|NCT00828178|P2|Participant Flow|Placebo|Placebo (corn starch) once daily
467727|NCT00828178|P1|Participant Flow|Fish Oil|fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily
467728|NCT00828178|O2|Outcome|Placebo|Corn Starch
467729|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
467730|NCT00828178|O2|Outcome|Placebo|Placebo (cornstarch)
467731|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
467732|NCT00828178|O2|Outcome|Placebo|Corn starch
467733|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
467734|NCT00828178|E2|Reported Event|Placebo|Placebo (cornstarch)
467735|NCT00828178|E1|Reported Event|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
467736|NCT00828139|B5|Baseline|Total|Total of all reporting groups
467737|NCT00828139|B4|Baseline|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
467738|NCT00828139|B3|Baseline|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
467739|NCT00828139|B2|Baseline|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
467740|NCT00828139|B1|Baseline|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
467741|NCT00828139|P4|Participant Flow|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
467742|NCT00828139|P3|Participant Flow|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
467743|NCT00828139|P2|Participant Flow|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
467744|NCT00828139|P1|Participant Flow|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
467745|NCT00828139|O2|Outcome|Topotecan|
467746|NCT00828139|O1|Outcome|Ziv-aflibercept + Topotecan|
467747|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
467748|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
467749|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
467750|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
467751|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
467752|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
467753|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
467754|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
467755|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
467756|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
467757|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
467758|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
467759|NCT00828139|E2|Reported Event|Topotecan|There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis.
467760|NCT00828139|E1|Reported Event|Ziv-aflibercept + Topotecan|There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis.
467761|NCT00828113|B3|Baseline|Total|Total of all reporting groups
467762|NCT00828113|B2|Baseline|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
467763|NCT00828113|B1|Baseline|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
467764|NCT00828113|P2|Participant Flow|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
467765|NCT00828113|P1|Participant Flow|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
467766|NCT00828113|O2|Outcome|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
467767|NCT00828113|O1|Outcome|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
472094|NCT00816829|O1|Outcome|Placebo|Placebo
467768|NCT00828113|E2|Reported Event|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
467769|NCT00828113|E1|Reported Event|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
467770|NCT00828074|B3|Baseline|Total|Total of all reporting groups
467771|NCT00828074|B2|Baseline|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467772|NCT00828074|B1|Baseline|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467773|NCT00828074|P3|Participant Flow|Phase II - Vinorelbine 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467774|NCT00828074|P2|Participant Flow|Phase I - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467775|NCT00828074|P1|Participant Flow|Phase I - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467776|NCT00828074|O1|Outcome|Phase I & II|"Patients receive sorafenib tosylate PO twice daily on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Dose level 1 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 2 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle.~vinorelbine ditartrate: Dose level 1 = 20 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 2 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle."
467777|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
467778|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
467779|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
467780|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine I.V. 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
467781|NCT00828074|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
467782|NCT00828074|O2|Outcome|Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467783|NCT00828074|O1|Outcome|Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467784|NCT00828074|E2|Reported Event|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467785|NCT00828074|E1|Reported Event|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
467786|NCT00828061|B1|Baseline|All Patients|All patients who completed at least one period are included in the analysis
467787|NCT00828061|P6|Participant Flow|Prednisone / Prednisone / Placebo|1 day 25 mg prednisone, 1 day 10 mg prednisone, 1 day placebo
467788|NCT00828061|P5|Participant Flow|Prednisone / Placebo / Prednisone|1 day 10 mg prednisone, 1 day placebo, 1 day 25 mg prednisone
467789|NCT00828061|P4|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 25 mg prednisone, 1 day 10 mg prednisone
467790|NCT00828061|P3|Participant Flow|Prednisone / Placebo / Prednisone|1 day 25 mg prednisone, 1 day placebo, 1 day 10 mg prednisone
467791|NCT00828061|P2|Participant Flow|Prednisone / Prednisone / Placebo|1 day 10 mg prednisone, 1 day 25 mg prednisone, 1 day placebo
467792|NCT00828061|P1|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 10 mg prednisone, 1 day 25 mg prednisone
467793|NCT00828061|O3|Outcome|25 mg Prednisone|
467794|NCT00828061|O2|Outcome|10 mg Prednisone|
467795|NCT00828061|O1|Outcome|Placebo|
467796|NCT00828061|O3|Outcome|25 mg Prednisone|
467797|NCT00828061|O2|Outcome|10 mg Prednisone|
467798|NCT00828061|O1|Outcome|Placebo|
467799|NCT00828061|E3|Reported Event|25 mg Prednisone|
467800|NCT00828061|E2|Reported Event|10 mg Prednisone|
467801|NCT00828061|E1|Reported Event|Placebo|
467802|NCT00827983|B3|Baseline|Total|Total of all reporting groups
467803|NCT00827983|B2|Baseline|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467804|NCT00827983|B1|Baseline|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467805|NCT00827983|P2|Participant Flow|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467806|NCT00827983|P1|Participant Flow|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467807|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467808|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467809|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467810|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467811|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467812|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467813|NCT00827983|E2|Reported Event|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467814|NCT00827983|E1|Reported Event|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
467815|NCT00827944|B3|Baseline|Total|Total of all reporting groups
467816|NCT00827944|B2|Baseline|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467817|NCT00827944|B1|Baseline|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467818|NCT00827944|P2|Participant Flow|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467819|NCT00827944|P1|Participant Flow|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467820|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467821|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467822|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467823|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467824|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467825|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467826|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467827|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467828|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467829|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467830|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467831|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467832|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467833|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467834|NCT00827944|E2|Reported Event|Lichtenstein Group|"Low weight polypropylene mesh~Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
467835|NCT00827944|E1|Reported Event|Progrip Group|"Parietex ProGrip~Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
467836|NCT00827931|B3|Baseline|Total|Total of all reporting groups
467837|NCT00827931|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467838|NCT00827931|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467839|NCT00827931|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467840|NCT00827931|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467841|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467877|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467842|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467843|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467844|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467845|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467846|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467847|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467848|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467849|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467850|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467851|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467852|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467853|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467854|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467855|NCT00827931|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
467856|NCT00827931|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
467857|NCT00827918|B4|Baseline|Total|Total of all reporting groups
467858|NCT00827918|B3|Baseline|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467859|NCT00827918|B2|Baseline|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467860|NCT00827918|B1|Baseline|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467861|NCT00827918|P3|Participant Flow|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467862|NCT00827918|P2|Participant Flow|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467863|NCT00827918|P1|Participant Flow|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467864|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467865|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467866|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467867|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467868|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467869|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467870|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467871|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467872|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467873|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467874|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467875|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467878|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467879|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467880|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467881|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467882|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467883|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467884|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467885|NCT00827918|E3|Reported Event|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
467886|NCT00827918|E2|Reported Event|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
467887|NCT00827918|E1|Reported Event|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
467888|NCT00827827|B3|Baseline|Total|Total of all reporting groups
467889|NCT00827827|B2|Baseline|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467890|NCT00827827|B1|Baseline|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467891|NCT00827827|P2|Participant Flow|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467892|NCT00827827|P1|Participant Flow|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467893|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467894|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467895|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467896|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467897|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467898|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467899|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467900|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467901|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467902|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467903|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467904|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467905|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467906|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467907|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467908|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467909|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467910|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467911|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467912|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467913|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
468797|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
467914|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467915|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467916|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467917|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467918|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467919|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467920|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467921|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467922|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467923|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467924|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467925|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467926|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467927|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
468856|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5g PA21 (6 tablets)
467928|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467929|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467930|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467931|NCT00827827|E2|Reported Event|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
467932|NCT00827827|E1|Reported Event|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
467933|NCT00827632|B3|Baseline|Total|Total of all reporting groups
467934|NCT00827632|B2|Baseline|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
467935|NCT00827632|B1|Baseline|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
467936|NCT00827632|P2|Participant Flow|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
467937|NCT00827632|P1|Participant Flow|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
467938|NCT00827632|O2|Outcome|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
467939|NCT00827632|O1|Outcome|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
467940|NCT00827632|E2|Reported Event|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
467941|NCT00827632|E1|Reported Event|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
467942|NCT00827606|B3|Baseline|Total|Total of all reporting groups
467943|NCT00827606|B2|Baseline|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467944|NCT00827606|B1|Baseline|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467945|NCT00827606|P2|Participant Flow|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467946|NCT00827606|P1|Participant Flow|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target low-density lipoprotein cholesterol (LDL-C) (<3.35 millimoles per liter [mmol/L]) was not attained.
467947|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467948|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467949|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467950|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467951|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467952|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467953|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467954|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467955|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467956|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467957|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467958|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467959|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467960|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467961|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467962|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467963|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468122|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
467964|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467965|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467966|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467967|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467968|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467969|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467970|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467971|NCT00827606|O5|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 5|Participants aged ≥10 to 15 years, at Tanner_Stage 5 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467972|NCT00827606|O4|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 4|Participants aged ≥10 to 15 years, at Tanner_Stage 4 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467973|NCT00827606|O3|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 3|Participants aged ≥10 to 15 years, at Tanner_Stage 3 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467974|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 2|Participants aged ≥10 to 15 years, at Tanner_Stage 2 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467975|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Baseline Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467976|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468020|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
467977|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467978|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467979|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467980|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467981|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467982|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467983|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467984|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467985|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467986|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467987|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467988|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467989|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467990|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467991|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467992|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467993|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467994|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467995|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467996|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467997|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467998|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
467999|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468000|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468001|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468002|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468003|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468004|NCT00827606|E2|Reported Event|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468005|NCT00827606|E1|Reported Event|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
468006|NCT00827567|B1|Baseline|RAD 001|RAD001-10 mg by mouth once everyday
468007|NCT00827567|P1|Participant Flow|RAD 001|RAD001-10 mg by mouth once everyday
468008|NCT00827567|O1|Outcome|RAD 001|RAD001-10 mg by mouth once everyday
468009|NCT00827567|E1|Reported Event|RAD 001|RAD001-10 mg by mouth once everyday
468010|NCT00827541|B3|Baseline|Total|Total of all reporting groups
468011|NCT00827541|B2|Baseline|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468012|NCT00827541|B1|Baseline|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468013|NCT00827541|P2|Participant Flow|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468014|NCT00827541|P1|Participant Flow|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468015|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468016|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468017|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468018|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468019|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468059|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468021|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468022|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468023|NCT00827541|E2|Reported Event|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468024|NCT00827541|E1|Reported Event|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
468025|NCT00827502|B1|Baseline|Azithromycin|
468026|NCT00827502|P1|Participant Flow|Azithromycin|The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.
468027|NCT00827502|O1|Outcome|Azithromycin|
468028|NCT00827502|O1|Outcome|Azithromycin|
468029|NCT00827502|O1|Outcome|Azithromycin|
468030|NCT00827502|E1|Reported Event|Azithromycin|
468031|NCT00827372|B1|Baseline|Overall Study|All patients who were treated
468032|NCT00827372|P1|Participant Flow|Overall Study|All patients who were treated
468033|NCT00827372|O1|Outcome|Overall|All patients who were treated
468034|NCT00827372|O1|Outcome|Overall|All patients who were treated
468035|NCT00827372|O1|Outcome|Overall|All patients who were treated
468036|NCT00827372|O1|Outcome|Overall|All patients who were treated
468037|NCT00827372|O1|Outcome|Overall Study|All patients who were treated
468038|NCT00827372|E1|Reported Event|Overall|All patients who were treated
468039|NCT00827255|B1|Baseline|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
468040|NCT00827255|P1|Participant Flow|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
468041|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
468042|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
468043|NCT00827255|E1|Reported Event|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
468044|NCT00827242|B3|Baseline|Total|Total of all reporting groups
468045|NCT00827242|B2|Baseline|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468046|NCT00827242|B1|Baseline|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468047|NCT00827242|P2|Participant Flow|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468048|NCT00827242|P1|Participant Flow|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468049|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468050|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468051|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468052|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468053|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468054|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468055|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468056|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468057|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468058|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468857|NCT00824460|O2|Outcome|5.0g PA21 (1,000 mg Iron)|Daily dose of 5.0g PA21 (4 tablets)
468060|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468061|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468062|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468063|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468064|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468065|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468066|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468067|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468068|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468069|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468070|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468071|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468072|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468073|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468074|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468075|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468076|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468077|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468078|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468079|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468080|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468081|NCT00827242|E2|Reported Event|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
468082|NCT00827242|E1|Reported Event|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
468083|NCT00827112|B3|Baseline|Total|Total of all reporting groups
468084|NCT00827112|B2|Baseline|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468085|NCT00827112|B1|Baseline|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468086|NCT00827112|P2|Participant Flow|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468087|NCT00827112|P1|Participant Flow|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468088|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468089|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468090|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468091|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468092|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468093|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468094|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468095|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468096|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468097|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468098|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468099|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468100|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468101|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468102|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468103|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468104|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468105|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468106|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468107|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468108|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468109|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468110|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468111|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468112|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468113|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468114|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468115|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468116|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
468117|NCT00827112|E2|Reported Event|Atazanavir / Ritonavir + Emtricitabine/ Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
468118|NCT00827112|E1|Reported Event|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks.
468119|NCT00827099|B1|Baseline|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
468120|NCT00827099|P1|Participant Flow|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
468121|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
468123|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
468124|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
468125|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
468126|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
468127|NCT00827099|E1|Reported Event|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
468128|NCT00827073|B3|Baseline|Total|Total of all reporting groups
468129|NCT00827073|B2|Baseline|Lidocaine 2% Jelly|"betadine: betadine 5%~anesthetic"
468130|NCT00827073|B1|Baseline|Tetracaine 5% Drop|"betadine: betadine 5%~topical anesthetic"
468131|NCT00827073|P2|Participant Flow|Lidocaine 2% Jelly|betadine: betadine 5% Anesthetic: lidocaine 2% jelly
468132|NCT00827073|P1|Participant Flow|Tetracaine 5% Drop|betadine: betadine 5%, topical anesthetic drop
468133|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
468134|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%~topical anesthetic"
468135|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
468136|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%~topical anesthetic"
468137|NCT00827073|E2|Reported Event|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
468138|NCT00827073|E1|Reported Event|Tetracaine 0.5% Drop|"betadine: betadine 5%~Topical Anesthetic"
468139|NCT00826943|B1|Baseline|All Study Participants|Cross Over (all participants received all interventions)
468140|NCT00826943|P6|Participant Flow|C Then P Then L|cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each)
468141|NCT00826943|P5|Participant Flow|C Then L Then P|cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
468142|NCT00826943|P4|Participant Flow|P Then C Then L|placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each)
468143|NCT00826943|P3|Participant Flow|P Then L Then C|placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each)
468144|NCT00826943|P2|Participant Flow|L Then P Then C|Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each)
468145|NCT00826943|P1|Participant Flow|L Then C Then P|Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
468146|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
468147|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
468148|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
468149|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
468150|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
468151|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
468152|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
468153|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
468154|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
468155|NCT00826943|E3|Reported Event|Cetirizine|cross over = all participants received all interventions
468156|NCT00826943|E2|Reported Event|Levocetirizine|cross over (all participants received all interventions)
468157|NCT00826943|E1|Reported Event|Placebo|Cross Over (all participants received all interventions)
468158|NCT00826800|B1|Baseline|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
468159|NCT00826800|P1|Participant Flow|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
468160|NCT00826800|O1|Outcome|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
468161|NCT00826800|E1|Reported Event|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
468162|NCT00826748|B4|Baseline|Total|Total of all reporting groups
468163|NCT00826748|B3|Baseline|Non-smokers|Non-Smokers will act as a control and includes healthy non-smokers who received no treatment.
468164|NCT00826748|B2|Baseline|Non-Treated Smokers|Non-Treated Smokers will act as a control and includes healthy smokers who received no treatment.
468165|NCT00826748|B1|Baseline|Treated Smokers|The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
468166|NCT00826748|P3|Participant Flow|Non-Smokers|Non-Smokers will act as control and include healthy non-smokers who receive no treatment.
468167|NCT00826748|P2|Participant Flow|Non-Treated Smokers|Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
468203|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468858|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25g PA21 (1 tablet)
468168|NCT00826748|P1|Participant Flow|Treated Smokers|The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days.
468169|NCT00826748|O3|Outcome|Non-Smokers|Non-Smokers will act as control and include healthy non-smokers who receive no treatment. Two subjects withdrew consent prior to the Day 7 timepoint, therefore only 10 subjects have data available past Day 7.
468170|NCT00826748|O2|Outcome|Non-Treated Smokers|Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
468171|NCT00826748|O1|Outcome|Treated Smokers|The treatment with inhaled beclomethasone will be administered to Treated Smokers from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. QVAR will be purchased by the Department of Genetic Medicine. The dose will be 2 puffs twice a day for 7 days
468172|NCT00826748|E3|Reported Event|Non-smokers|Non-Smokers will act as control and include healthy non-smokers who receive no treatment.
468173|NCT00826748|E2|Reported Event|Non-Treated Smokers|Non-Treated Smokers will act as control and include healthy smokers who receive no treatment.
468174|NCT00826748|E1|Reported Event|Treated Smokers|Treated Smokers will be administered with 320 micrograms (mcg) of beclomethasone daily from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. The dose will be 2 puffs twice a day for 7 days.
468175|NCT00826618|B1|Baseline|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
468176|NCT00826618|P1|Participant Flow|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
468177|NCT00826618|O1|Outcome|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. Mean change in BCVA (assessed by the ETDRS chart at 4 m) from baseline at 12 months was 12.2 ETDRS letters (P = 0.015).
468178|NCT00826618|E1|Reported Event|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
468179|NCT00826540|B1|Baseline|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >~> bevacizumab: Given IV"
468180|NCT00826540|P1|Participant Flow|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >~> bevacizumab: Given IV"
468181|NCT00826540|O1|Outcome|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies >~> sorafenib tosylate: Given orally~>~> bevacizumab: Given IV"
468182|NCT00826540|E1|Reported Event|Treatment (Sorafenib Tosylate and Bevacizumab)|bevacizumab: Given IV
468183|NCT00826449|B3|Baseline|Total|Total of all reporting groups
468184|NCT00826449|B2|Baseline|Dasatinib + Erlotinib: Phase 2|MTD from Phase I Dasatinib orally dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
468185|NCT00826449|B1|Baseline|Dasatinib + Erlotinib: Phase I|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
468186|NCT00826449|P1|Participant Flow|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
468187|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
468188|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
468189|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
468190|NCT00826449|E1|Reported Event|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
468191|NCT00826280|B4|Baseline|Total|Total of all reporting groups
468192|NCT00826280|B3|Baseline|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468193|NCT00826280|B2|Baseline|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468194|NCT00826280|B1|Baseline|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468195|NCT00826280|P3|Participant Flow|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468196|NCT00826280|P2|Participant Flow|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468197|NCT00826280|P1|Participant Flow|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468198|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468199|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468200|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468201|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468202|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468204|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468205|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468206|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468207|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468208|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468209|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468210|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468211|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468212|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468213|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468214|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468215|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468216|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468217|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468218|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468219|NCT00826280|E3|Reported Event|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468220|NCT00826280|E2|Reported Event|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
468221|NCT00826280|E1|Reported Event|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
468222|NCT00826267|B4|Baseline|Total|Total of all reporting groups
468223|NCT00826267|B3|Baseline|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
468224|NCT00826267|B2|Baseline|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468225|NCT00826267|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468226|NCT00826267|P3|Participant Flow|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
468227|NCT00826267|P2|Participant Flow|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468228|NCT00826267|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468229|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
468230|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468231|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468232|NCT00826267|O1|Outcome|Afatinib 50mg|Patients received Afatinib 50 mg at day 7.
468233|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
468234|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468235|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468236|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
468237|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468238|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468239|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
468240|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468241|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468299|NCT00826111|O2|Outcome|Placebo|Open label escitalopram for 10 weeks together with placebo for 10 weeks.
468242|NCT00826267|E3|Reported Event|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
468243|NCT00826267|E2|Reported Event|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468244|NCT00826267|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
468245|NCT00826228|B1|Baseline|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
468246|NCT00826228|P1|Participant Flow|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing on a Lokomat
468247|NCT00826228|O1|Outcome|PTH/Weight-Bearing|
468248|NCT00826228|O1|Outcome|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
468249|NCT00826228|E1|Reported Event|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
468250|NCT00826202|B3|Baseline|Total|Total of all reporting groups
468251|NCT00826202|B2|Baseline|Placebo|Placebo: Inert Placebo
468252|NCT00826202|B1|Baseline|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
468253|NCT00826202|P2|Participant Flow|Placebo|Placebo: Inert Placebo
468254|NCT00826202|P1|Participant Flow|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
468255|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
468256|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
468257|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
468258|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
468259|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
468260|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
468261|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
468262|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
468263|NCT00826202|E2|Reported Event|Placebo|Placebo: Inert Placebo
468264|NCT00826202|E1|Reported Event|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
468265|NCT00826176|B3|Baseline|Total|Total of all reporting groups
468266|NCT00826176|B2|Baseline|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
468267|NCT00826176|B1|Baseline|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
468268|NCT00826176|P2|Participant Flow|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
468269|NCT00826176|P1|Participant Flow|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
468270|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
468271|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
468272|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
468273|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
468274|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
468275|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
468276|NCT00826176|E2|Reported Event|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
468277|NCT00826176|E1|Reported Event|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
468278|NCT00826111|B3|Baseline|Total|Total of all reporting groups
468279|NCT00826111|B2|Baseline|Placebo|Escitalopram with placebo
468280|NCT00826111|B1|Baseline|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468281|NCT00826111|P2|Participant Flow|Placebo|Escitalopram with placebo
468282|NCT00826111|P1|Participant Flow|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468283|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468284|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468285|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468286|NCT00826111|O1|Outcome|Eszopiclone|Escitalopram for 10 weeks together with eszopiclone.
468287|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468288|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468289|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468290|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468291|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468292|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468293|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468294|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468295|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468296|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468297|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
468298|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468300|NCT00826111|O1|Outcome|Eszopiclone|Open label escitalopram for 10 weeks together with 3 mg eszopiclone for eight weeks followed by placebo for two weeks.
468301|NCT00826111|E2|Reported Event|Placebo|Escitalopram with placebo
468302|NCT00826111|E1|Reported Event|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
468303|NCT00826007|B3|Baseline|Total|Total of all reporting groups
468304|NCT00826007|B2|Baseline|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
468305|NCT00826007|B1|Baseline|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
468306|NCT00826007|P2|Participant Flow|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
468307|NCT00826007|P1|Participant Flow|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
468308|NCT00826007|O2|Outcome|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
468309|NCT00826007|O1|Outcome|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
468310|NCT00826007|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
468311|NCT00825994|B1|Baseline|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
468312|NCT00825994|P1|Participant Flow|Omega-3|omega-3 fatty acids, 2g qd [every day] (2 x 1 gram tablets), PO [by mouth]
468313|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
468314|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
468315|NCT00825994|E1|Reported Event|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
468316|NCT00825916|B4|Baseline|Total|Total of all reporting groups
468317|NCT00825916|B3|Baseline|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468318|NCT00825916|B2|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468319|NCT00825916|B1|Baseline|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468320|NCT00825916|P3|Participant Flow|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468321|NCT00825916|P2|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468322|NCT00825916|P1|Participant Flow|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468323|NCT00825916|O9|Outcome|Scar Total Volume - 10 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468324|NCT00825916|O8|Outcome|Scar Total Volume - 3 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468325|NCT00825916|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468326|NCT00825916|O6|Outcome|Scar Negative Volume - 10 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468327|NCT00825916|O5|Outcome|Scar Negative Volume - 3 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468328|NCT00825916|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468329|NCT00825916|O3|Outcome|Scar Positive Volume - 10 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468330|NCT00825916|O2|Outcome|Scar Positive Volume - 3 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468331|NCT00825916|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468332|NCT00825916|O15|Outcome|Scar Mean Elevation - 10 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468333|NCT00825916|O14|Outcome|Scar Mean Elevation - 3 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468360|NCT00825916|E2|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468334|NCT00825916|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468335|NCT00825916|O12|Outcome|Scar Maximum Elevation - 10 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468336|NCT00825916|O11|Outcome|Scar Maximum Elevation - 3 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468337|NCT00825916|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468338|NCT00825916|O9|Outcome|Scar Minimum Elevation - 10 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468339|NCT00825916|O8|Outcome|Scar Minimum Elevation - 3 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468340|NCT00825916|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468341|NCT00825916|O6|Outcome|Scar Width - 10 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468342|NCT00825916|O5|Outcome|Scar Width - 3 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468343|NCT00825916|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468344|NCT00825916|O3|Outcome|Scar Length - 10 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468345|NCT00825916|O2|Outcome|Scar Length - 3 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468346|NCT00825916|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468347|NCT00825916|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468348|NCT00825916|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468349|NCT00825916|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468350|NCT00825916|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468351|NCT00825916|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468352|NCT00825916|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468353|NCT00825916|O6|Outcome|OSAS Results for 10 mg AZX100|This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468354|NCT00825916|O5|Outcome|OSAS Results for 3 mg AZX100|This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468355|NCT00825916|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468356|NCT00825916|O3|Outcome|PSAS Results for 10 mg AZX100|This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468357|NCT00825916|O2|Outcome|PSAS Results for 3 mg AZX100|This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468358|NCT00825916|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468359|NCT00825916|E3|Reported Event|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
472095|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
468361|NCT00825916|E1|Reported Event|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
468362|NCT00825825|B1|Baseline|Entire Study Population|Includes all randomized subjects regardless of order in which they received medications
468363|NCT00825825|P6|Participant Flow|Placebo First / Citalopram Second / Escitalopram Third|2 weeks of placebo followed by 2 weeks of citalopram followed by 2 weeks escitalopram
468364|NCT00825825|P5|Participant Flow|Placebo First / Escitalopram Second / Citalopram Third|2 weeks of placebo followed by 2 weeks of escitalopram followed by 2 weeks of citalopram
468365|NCT00825825|P4|Participant Flow|Citalopram First / Placebo Second / Escitalopram Third|2 weeks of citalopram followed by 2 weeks of placebo followed by 2 weeks of escitalopram
468366|NCT00825825|P3|Participant Flow|Citalopram First / Escitalopram Second / Placebo Third|2 weeks of citalopram followed by 2 weeks of escitalopram followed by 2 weeks of placebo
468367|NCT00825825|P2|Participant Flow|Escitalopram First / Placebo Second / Citalopram Third|2 weeks of escitalopram followed by 2 weeks of placebo followed by 2 weeks of citalopram
468368|NCT00825825|P1|Participant Flow|Escitalopram First / Citalopram Second / Placebo Third|2 weeks of escitalopram followed by 2 weeks of citalopram followed by 2 weeks of placebo
468369|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
468370|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
468371|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
468372|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
468373|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
468374|NCT00825825|O1|Outcome|All Participants With Complete Usuable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
468375|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
468376|NCT00825825|E3|Reported Event|Placebo|Includes all subjects who received placebo in one of the three medication periods
468377|NCT00825825|E2|Reported Event|Citalopram|Includes all subjects who received citalopram in one of the three medication periods
468378|NCT00825825|E1|Reported Event|Escitalopram|Includes all subjects who received escitalopram in one of the three medication periods
468379|NCT00825812|B5|Baseline|Total|Total of all reporting groups
468380|NCT00825812|B4|Baseline|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468381|NCT00825812|B3|Baseline|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468382|NCT00825812|B2|Baseline|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468383|NCT00825812|B1|Baseline|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468384|NCT00825812|P4|Participant Flow|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468385|NCT00825812|P3|Participant Flow|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468386|NCT00825812|P2|Participant Flow|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468387|NCT00825812|P1|Participant Flow|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468388|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468389|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468390|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468391|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468792|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468392|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468393|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468394|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468395|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468396|NCT00825812|E4|Reported Event|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468397|NCT00825812|E3|Reported Event|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468398|NCT00825812|E2|Reported Event|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
468399|NCT00825812|E1|Reported Event|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
468400|NCT00825786|B3|Baseline|Total|Total of all reporting groups
468401|NCT00825786|B2|Baseline|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468402|NCT00825786|B1|Baseline|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468403|NCT00825786|P2|Participant Flow|Control|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468404|NCT00825786|P1|Participant Flow|Treatment|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468405|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468406|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468407|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468408|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468409|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468410|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468411|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468412|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468413|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468414|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468415|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468447|NCT00825630|B2|Baseline|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
468448|NCT00825630|B1|Baseline|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
468416|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468417|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468418|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468419|NCT00825786|E2|Reported Event|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468420|NCT00825786|E1|Reported Event|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
468421|NCT00825734|B1|Baseline|All Patients|"Patients treated at all dose levels in the Phase I and Phase II portions of the study~: Dose Level 1 (4 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)~Dose Level -1 (3 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)~Dose Level 1a (76 patients) Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)"
468422|NCT00825734|P3|Participant Flow|Dose Level 1a|Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
468423|NCT00825734|P2|Participant Flow|Dose Level -1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)
468424|NCT00825734|P1|Participant Flow|Dose Level 1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)
468425|NCT00825734|O1|Outcome|Phase II - Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
468426|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
468427|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
468428|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
468429|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
468430|NCT00825734|E1|Reported Event|Dose Level 1a|Includes patients treated at the Phase II dose - Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
468431|NCT00825682|B3|Baseline|Total|Total of all reporting groups
468432|NCT00825682|B2|Baseline|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
468433|NCT00825682|B1|Baseline|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
468434|NCT00825682|P2|Participant Flow|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
468435|NCT00825682|P1|Participant Flow|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
468436|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
468437|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
468438|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
468439|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. Five women did not begin the study and 8 women did not complete reflexology treatments due to personal reasons / inconvenience
468440|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
468441|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
468442|NCT00825682|E2|Reported Event|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
468443|NCT00825682|E1|Reported Event|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
468444|NCT00825630|B5|Baseline|Total|Total of all reporting groups
468445|NCT00825630|B4|Baseline|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
468446|NCT00825630|B3|Baseline|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
468449|NCT00825630|P4|Participant Flow|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
468450|NCT00825630|P3|Participant Flow|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
468451|NCT00825630|P2|Participant Flow|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
468452|NCT00825630|P1|Participant Flow|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
468453|NCT00825630|O4|Outcome|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
468454|NCT00825630|O3|Outcome|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
468455|NCT00825630|O2|Outcome|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
468456|NCT00825630|O1|Outcome|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
468457|NCT00825630|E4|Reported Event|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
468458|NCT00825630|E3|Reported Event|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
468459|NCT00825630|E2|Reported Event|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
468460|NCT00825630|E1|Reported Event|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
468461|NCT00825565|B1|Baseline|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
468462|NCT00825565|P1|Participant Flow|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
468463|NCT00825565|O4|Outcome|Lower Limbs|
468464|NCT00825565|O3|Outcome|Trunk|
468465|NCT00825565|O2|Outcome|Upper Limbs|
468466|NCT00825565|O1|Outcome|Head/Neck|
468467|NCT00825565|O1|Outcome|Alwextin Cream|"8 subjects enrolled in this single study arm. All 8 subjects completed the study.~Alwextin cream: Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration."
468468|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the target lesion area for assessing the impact on target wound closure.
468469|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
468470|NCT00825565|E1|Reported Event|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
468471|NCT00825500|B4|Baseline|Total|Total of all reporting groups
468472|NCT00825500|B3|Baseline|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468473|NCT00825500|B2|Baseline|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468474|NCT00825500|B1|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
468475|NCT00825500|P3|Participant Flow|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468476|NCT00825500|P2|Participant Flow|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468477|NCT00825500|P1|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
468478|NCT00825500|O3|Outcome|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468479|NCT00825500|O2|Outcome|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468480|NCT00825500|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
468481|NCT00825500|O3|Outcome|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468482|NCT00825500|O2|Outcome|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468483|NCT00825500|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
468484|NCT00825500|E3|Reported Event|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468485|NCT00825500|E2|Reported Event|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
468486|NCT00825500|E1|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
468487|NCT00825370|B3|Baseline|Total|Total of all reporting groups
468488|NCT00825370|B2|Baseline|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
468489|NCT00825370|B1|Baseline|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
468490|NCT00825370|P2|Participant Flow|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
468491|NCT00825370|P1|Participant Flow|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
468492|NCT00825370|O2|Outcome|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
468493|NCT00825370|O1|Outcome|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
468494|NCT00825370|O2|Outcome|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
468495|NCT00825370|O1|Outcome|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
468496|NCT00825370|O2|Outcome|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
468497|NCT00825370|O1|Outcome|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
468498|NCT00825370|O2|Outcome|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
468499|NCT00825370|O1|Outcome|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
468500|NCT00825370|E2|Reported Event|Discretionary Care|"Patients receive an IV opioid the type and dose of which is determined by the treating physician~IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well."
468501|NCT00825370|E1|Reported Event|Protocolized|"1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?~Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later"
468502|NCT00825344|B3|Baseline|Total|Total of all reporting groups
468503|NCT00825344|B2|Baseline|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
468504|NCT00825344|B1|Baseline|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
468505|NCT00825344|P2|Participant Flow|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
468506|NCT00825344|P1|Participant Flow|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
468507|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
468508|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
468509|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
468510|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
468511|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
468512|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
468513|NCT00825344|E2|Reported Event|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
468514|NCT00825344|E1|Reported Event|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
468515|NCT00825318|B1|Baseline|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
468516|NCT00825318|P1|Participant Flow|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
468517|NCT00825318|O3|Outcome|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
468518|NCT00825318|O2|Outcome|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
468519|NCT00825318|O1|Outcome|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
468520|NCT00825318|E3|Reported Event|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
468521|NCT00825318|E2|Reported Event|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
468522|NCT00825318|E1|Reported Event|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
468523|NCT00825305|B3|Baseline|Total|Total of all reporting groups
468524|NCT00825305|B2|Baseline|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
468525|NCT00825305|B1|Baseline|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
468526|NCT00825305|P2|Participant Flow|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
468527|NCT00825305|P1|Participant Flow|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
468528|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
468529|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
468530|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
468531|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
468532|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
468533|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
468534|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
468535|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
468536|NCT00825305|E2|Reported Event|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
468537|NCT00825305|E1|Reported Event|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
468538|NCT00825266|B3|Baseline|Total|Total of all reporting groups
468539|NCT00825266|B2|Baseline|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
468540|NCT00825266|B1|Baseline|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
468541|NCT00825266|P2|Participant Flow|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
468542|NCT00825266|P1|Participant Flow|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg twice daily for 4 weeks, then 125mg BID for duration of study."
468543|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
468544|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
468545|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
468546|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
468547|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
468548|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
468549|NCT00825266|E2|Reported Event|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
468550|NCT00825266|E1|Reported Event|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
468551|NCT00825227|B3|Baseline|Total|Total of all reporting groups
468552|NCT00825227|B2|Baseline|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
468553|NCT00825227|B1|Baseline|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
468554|NCT00825227|P2|Participant Flow|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
468555|NCT00825227|P1|Participant Flow|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
468556|NCT00825227|O2|Outcome|Patient Responses to Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents~Placebo,: - placebo~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
468557|NCT00825227|O1|Outcome|Patient Responses to 150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents~Armodafinil 150 mg/day: - 150 mg/day armodafinil~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
468600|NCT00825162|E2|Reported Event|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468601|NCT00825162|E1|Reported Event|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468558|NCT00825227|O2|Outcome|Patient Responses to Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents~Placebo,: - placebo~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
468559|NCT00825227|O1|Outcome|Patient Responses to 150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents~Armodafinil 150 mg/day: - 150 mg/day armodafinil~concurrent with one cycle of taxane chemotherapy alone or in combination with other agents~patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents"
468560|NCT00825227|O2|Outcome|Armodafinil 150 mg/Day|"150 mg/day armodafinil (3 tablets of 50 mg armodafinil)~taxane chemotherapy treatment alone or in combination with other agents"
468561|NCT00825227|O1|Outcome|Placebo|"Placebo (3 tablets matching armodafinil tablets)~taxane chemotherapy treatment alone or in combination with other agents"
468562|NCT00825227|E2|Reported Event|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
468563|NCT00825227|E1|Reported Event|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
468564|NCT00825175|B3|Baseline|Total|Total of all reporting groups
468565|NCT00825175|B2|Baseline|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
468566|NCT00825175|B1|Baseline|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
468567|NCT00825175|P2|Participant Flow|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
468568|NCT00825175|P1|Participant Flow|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
468569|NCT00825175|O2|Outcome|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
468570|NCT00825175|O1|Outcome|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
468571|NCT00825175|E2|Reported Event|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
468572|NCT00825175|E1|Reported Event|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
468573|NCT00825162|B4|Baseline|Total|Total of all reporting groups
468574|NCT00825162|B3|Baseline|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468575|NCT00825162|B2|Baseline|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468576|NCT00825162|B1|Baseline|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468577|NCT00825162|P3|Participant Flow|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468578|NCT00825162|P2|Participant Flow|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468579|NCT00825162|P1|Participant Flow|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468580|NCT00825162|O3|Outcome|Cohort C|
468581|NCT00825162|O2|Outcome|Cohort B|
468582|NCT00825162|O1|Outcome|Cohort A|
468583|NCT00825162|O3|Outcome|Cohort C|
468584|NCT00825162|O2|Outcome|Cohort B|
468585|NCT00825162|O1|Outcome|Cohort A|
468586|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
468587|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
468588|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
468589|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
468590|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
468591|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
468592|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
468593|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
468594|NCT00825162|O3|Outcome|Cohort C|
468595|NCT00825162|O2|Outcome|Cohort B|
468596|NCT00825162|O1|Outcome|Cohort A|
468597|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
468598|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
468599|NCT00825162|E3|Reported Event|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
468602|NCT00824993|B3|Baseline|Total|Total of all reporting groups
472096|NCT00816829|O1|Outcome|Placebo|Placebo
468604|NCT00824993|B1|Baseline|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
468605|NCT00824993|P2|Participant Flow|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
468606|NCT00824993|P1|Participant Flow|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
468607|NCT00824993|O2|Outcome|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
468608|NCT00824993|O1|Outcome|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
468609|NCT00824993|E2|Reported Event|Control|Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
468610|NCT00824993|E1|Reported Event|Ibandronate|One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months
468611|NCT00824850|B3|Baseline|Total|Total of all reporting groups
468612|NCT00824850|B2|Baseline|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468613|NCT00824850|B1|Baseline|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468614|NCT00824850|P2|Participant Flow|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468615|NCT00824850|P1|Participant Flow|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468616|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468617|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468618|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468619|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468620|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468621|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468622|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468623|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468624|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468625|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468626|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468627|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468628|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468629|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468630|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468631|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468632|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468633|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468634|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468635|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468636|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468637|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468638|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468639|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468640|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468641|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468642|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468643|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468644|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468645|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468793|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468646|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468647|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468648|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468649|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468650|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468651|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468652|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468653|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468654|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
468655|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
468656|NCT00824850|E2|Reported Event|MnCC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=20; Local reactions N=36; Systemic events N=36."
468657|NCT00824850|E1|Reported Event|7vPnC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=22; Local reactions N=38; Systemic events N=38."
468658|NCT00824824|B3|Baseline|Total|Total of all reporting groups
468659|NCT00824824|B2|Baseline|POAG With RVD|7 subjects with POAG were identified to have retinal vascular dysregulation (RVD). We determined whether RVD was present in the following way. The percentage change between the retinal blood flow measured while reclining for 30 min and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the retinal blood flow while reclining compared to sitting was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ±2 standard deviations about the mean percentage change found in the control group in our previous study. Subjects with a change in retinal blood flow induced by posture change outside of -17.5% to +35.5% where considered to have RVD.
468660|NCT00824824|B1|Baseline|Primary Open Angle Glaucoma|Subjects of either gender with age range 40 to 80 years old with POAG were eligible for the study. Eligible subjects had a history of an untreated IOP > 21 mmHg in the left eye and a CPSD ≥ 1.0 in this eye. Patients being treated with more than two IOP lowering medications concurrently were excluded. All eligible subjects had open angles on gonioscopy with the filtering portion of the trabecular meshwork visible for 360° in both eyes. All subjects also had at least two reliable Humphrey 24-2 full threshold visual fields that showed reproducible loss in the left eye on tests with fixation loss ≤33%, false positives ≤ 20% and false negatives ≤ 20%. Patients with evidence of exfoliation or pigment dispersion syndrome in either eye were excluded. Subjects with diabetic retinopathy or a history of ocular laser or incisional surgery in either eye were also excluded.
468661|NCT00824824|P2|Participant Flow|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
468662|NCT00824824|P1|Participant Flow|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
468663|NCT00824824|O2|Outcome|Brimonidine-Timolol|Post timolol-brimonidine outcome: 6 of the 7 patients were tested following timolol-brimonidine. One of the 7 patients could not be tested due to technical issues. Of the 6 that were tested, 4 patients had retinal vascular autoregulation that was in the normal range. Two patients continued to show RVD.
468664|NCT00824824|O1|Outcome|Dorzolamide-Timolol|Post timolol-dorzolamide outcome: All 7 patients who had RVD following timolol had retinal vascular autoregulation that was in the normal range.
468665|NCT00824824|E2|Reported Event|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
468666|NCT00824824|E1|Reported Event|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
468794|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468667|NCT00824772|B1|Baseline|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
468668|NCT00824772|P1|Participant Flow|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
468669|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
468670|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
468671|NCT00824772|E1|Reported Event|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
468672|NCT00824746|B1|Baseline|Single Arm|Gefitinib retreatment
468673|NCT00824746|P1|Participant Flow|Gefitinib Retreatment Group|Gefitinib retreatment group Patients who were previously treated with gefitinib followed by at least one line of cytotoxic chemotherapy can be enrolled to this retreatment group.
468674|NCT00824746|O1|Outcome|Single Arm|Gefitinib retreatment
468675|NCT00824746|O1|Outcome|Gefitinib Retreatment Group|Gefitinib retreatment
468676|NCT00824746|O1|Outcome|Gefitinib Retreatment Arm|Gefitinib retreatment arm
468677|NCT00824746|E1|Reported Event|Single Arm|Gefitinib retreatment
468678|NCT00824733|B1|Baseline|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
468679|NCT00824733|P1|Participant Flow|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
468680|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
468681|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
468682|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
468683|NCT00824733|E1|Reported Event|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
468684|NCT00824720|B4|Baseline|Total|Total of all reporting groups
468685|NCT00824720|B3|Baseline|Placebo|punctal plug without bimatoprost
468686|NCT00824720|B2|Baseline|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
468687|NCT00824720|B1|Baseline|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
468688|NCT00824720|P3|Participant Flow|Placebo|punctal plug without bimatoprost
468689|NCT00824720|P2|Participant Flow|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
468690|NCT00824720|P1|Participant Flow|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
468691|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
468692|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
468693|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
468694|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
468695|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
468696|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
468697|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
468698|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
468699|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
468700|NCT00824720|E3|Reported Event|Placebo|punctal plug without bimatoprost
468701|NCT00824720|E2|Reported Event|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
468702|NCT00824720|E1|Reported Event|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
468703|NCT00824655|B3|Baseline|Total|Total of all reporting groups
468704|NCT00824655|B2|Baseline|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
468705|NCT00824655|B1|Baseline|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468706|NCT00824655|P2|Participant Flow|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
468707|NCT00824655|P1|Participant Flow|13vPnC/13vPnC|Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.
468708|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
468709|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468710|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468711|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
468712|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468713|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468714|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
468715|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468716|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468717|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
472097|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
468718|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
468719|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
468720|NCT00824655|E4|Reported Event|13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).
468721|NCT00824655|E3|Reported Event|13vPnC/13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).
468722|NCT00824655|E2|Reported Event|13vPnC/13vPnC at 6 Months of Age|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).
468723|NCT00824655|E1|Reported Event|13vPnC/13vPnC at 5 Months|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)
468724|NCT00824616|B3|Baseline|Total|Total of all reporting groups
468725|NCT00824616|B2|Baseline|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
468726|NCT00824616|B1|Baseline|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
468727|NCT00824616|P2|Participant Flow|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
468728|NCT00824616|P1|Participant Flow|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
468729|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
468730|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
468731|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
468732|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
468733|NCT00824616|E2|Reported Event|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
468734|NCT00824616|E1|Reported Event|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
468735|NCT00824564|B3|Baseline|Total|Total of all reporting groups
468736|NCT00824564|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468737|NCT00824564|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468738|NCT00824564|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468739|NCT00824564|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468740|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468741|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468742|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468743|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468744|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468745|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468746|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468747|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468748|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468749|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468750|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468795|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468796|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468751|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468752|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468753|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468754|NCT00824564|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
468755|NCT00824564|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
468756|NCT00824538|B1|Baseline|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468757|NCT00824538|P1|Participant Flow|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468758|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468759|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468760|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468761|NCT00824538|O1|Outcome|Sunitinib|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468762|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468763|NCT00824538|E1|Reported Event|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
468764|NCT00824512|B3|Baseline|Total|Total of all reporting groups
468765|NCT00824512|B2|Baseline|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
468766|NCT00824512|B1|Baseline|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468767|NCT00824512|P2|Participant Flow|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468768|NCT00824512|P1|Participant Flow|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468769|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468770|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468771|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468772|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468773|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468774|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468775|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468776|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468777|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468778|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468779|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468780|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468781|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468782|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468783|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468784|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468785|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468786|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468787|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468788|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468789|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468790|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468798|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468799|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468800|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468801|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468802|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468803|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468804|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468805|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468806|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468807|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468808|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468809|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468810|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468811|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
468812|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468813|NCT00824512|E2|Reported Event|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
468814|NCT00824512|E1|Reported Event|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
468815|NCT00824473|B3|Baseline|Total|Total of all reporting groups
468816|NCT00824473|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468817|NCT00824473|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468818|NCT00824473|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468819|NCT00824473|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468820|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468821|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468822|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468823|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468824|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468825|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468826|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468827|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468828|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468829|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468830|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468831|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468832|NCT00824473|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
468833|NCT00824473|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
468834|NCT00824460|B7|Baseline|Total|Total of all reporting groups
468835|NCT00824460|B6|Baseline|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
468836|NCT00824460|B5|Baseline|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
468837|NCT00824460|B4|Baseline|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
468838|NCT00824460|B3|Baseline|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
468839|NCT00824460|B2|Baseline|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
468840|NCT00824460|B1|Baseline|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
468841|NCT00824460|P6|Participant Flow|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
468842|NCT00824460|P5|Participant Flow|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
468843|NCT00824460|P4|Participant Flow|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
468844|NCT00824460|P3|Participant Flow|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
468845|NCT00824460|P2|Participant Flow|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
468846|NCT00824460|P1|Participant Flow|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
468847|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
468848|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
468849|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
468850|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
468851|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
468852|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
468853|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8g sevelamer hydrochloride (6 tablets)
468854|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5g PA21 (10 tablets)
468855|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
468859|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
468860|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
468861|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
468862|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
468863|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
468864|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
468865|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
468866|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
468867|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
468868|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
468869|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
468870|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
468871|NCT00824460|E6|Reported Event|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
468872|NCT00824460|E5|Reported Event|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
468873|NCT00824460|E4|Reported Event|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
468874|NCT00824460|E3|Reported Event|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
468875|NCT00824460|E2|Reported Event|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
468876|NCT00824460|E1|Reported Event|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
468877|NCT00824434|B1|Baseline|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468878|NCT00824434|P1|Participant Flow|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468879|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468880|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468881|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468882|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468883|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468884|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468885|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468886|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468887|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468888|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468889|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468890|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468891|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468892|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468893|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468894|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468895|NCT00824434|E1|Reported Event|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
468896|NCT00824421|B4|Baseline|Total|Total of all reporting groups
468897|NCT00824421|B3|Baseline|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468898|NCT00824421|B2|Baseline|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468957|NCT00824408|P1|Participant Flow|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468958|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468959|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468899|NCT00824421|B1|Baseline|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468900|NCT00824421|P3|Participant Flow|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468901|NCT00824421|P2|Participant Flow|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468902|NCT00824421|P1|Participant Flow|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468903|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468904|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468905|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468906|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468907|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468908|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468909|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468910|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
468911|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468960|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
472098|NCT00816829|O1|Outcome|Placebo|Placebo
468912|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468913|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468914|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468915|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468916|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468917|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468918|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468919|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468920|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468921|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468922|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468923|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468924|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468925|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468926|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468927|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468928|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468929|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468930|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468961|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468962|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468963|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
472099|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
468931|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468932|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468933|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468934|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468935|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468936|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468937|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468938|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468939|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468964|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
468965|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468966|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468967|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
468940|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468941|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468942|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468943|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468944|NCT00824421|E3|Reported Event|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468945|NCT00824421|E2|Reported Event|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468946|NCT00824421|E1|Reported Event|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
468947|NCT00824408|B6|Baseline|Total|Total of all reporting groups
468948|NCT00824408|B5|Baseline|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468949|NCT00824408|B4|Baseline|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
468950|NCT00824408|B3|Baseline|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
468951|NCT00824408|B2|Baseline|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468952|NCT00824408|B1|Baseline|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468953|NCT00824408|P5|Participant Flow|Randomized Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468954|NCT00824408|P4|Participant Flow|Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously on day 1 of each 21 day cycle
468955|NCT00824408|P3|Participant Flow|Randomized Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
468956|NCT00824408|P2|Participant Flow|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468968|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468969|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468970|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
468971|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468972|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468973|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468974|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
468975|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
468976|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468977|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468978|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468979|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468980|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468981|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
468982|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
468983|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468984|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468985|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468986|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
468987|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
468988|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468989|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
468990|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
468991|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468992|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
468993|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
468994|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468995|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
468996|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
468997|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
468998|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
468999|NCT00824408|E5|Reported Event|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
469000|NCT00824408|E4|Reported Event|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
469001|NCT00824408|E3|Reported Event|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
469002|NCT00824408|E2|Reported Event|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
469003|NCT00824408|E1|Reported Event|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
469004|NCT00824382|B5|Baseline|Total|Total of all reporting groups
469005|NCT00824382|B4|Baseline|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469006|NCT00824382|B3|Baseline|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469007|NCT00824382|B2|Baseline|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469009|NCT00824382|P4|Participant Flow|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469010|NCT00824382|P3|Participant Flow|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469011|NCT00824382|P2|Participant Flow|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469012|NCT00824382|P1|Participant Flow|Placebo|Placebo
469013|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469014|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469015|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469016|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469017|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469018|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469019|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469020|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469021|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469022|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469023|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469024|NCT00824382|O1|Outcome|Placebo|Placebo
469025|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469026|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469027|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469028|NCT00824382|O1|Outcome|Placebo|Placebo
469029|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469030|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469031|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469032|NCT00824382|O1|Outcome|Placebo|Placebo
469033|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469034|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469035|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469036|NCT00824382|O1|Outcome|Placebo|Placebo
469037|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469038|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469039|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469040|NCT00824382|O1|Outcome|Placebo|Placebo
469041|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469042|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469043|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469044|NCT00824382|O1|Outcome|Placebo|Placebo
469045|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469046|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469047|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469048|NCT00824382|O1|Outcome|Placebo|Placebo
469049|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469050|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469051|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469052|NCT00824382|O1|Outcome|Placebo|Placebo
469053|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469054|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469055|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469056|NCT00824382|O1|Outcome|Placebo|Placebo
469057|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469058|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469059|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469060|NCT00824382|O1|Outcome|Placebo|Placebo
469061|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469062|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469063|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469064|NCT00824382|O1|Outcome|Placebo|Placebo
469065|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469066|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469067|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469068|NCT00824382|O1|Outcome|Placebo|Placebo
469069|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469070|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469071|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469072|NCT00824382|O1|Outcome|Placebo|Placebo
469073|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469074|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469075|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469076|NCT00824382|O1|Outcome|Placebo|Placebo
469077|NCT00824382|E4|Reported Event|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
469078|NCT00824382|E3|Reported Event|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
469079|NCT00824382|E2|Reported Event|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
469082|NCT00824369|B6|Baseline|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469083|NCT00824369|B5|Baseline|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469084|NCT00824369|B4|Baseline|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469085|NCT00824369|B3|Baseline|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469086|NCT00824369|B2|Baseline|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469087|NCT00824369|B1|Baseline|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469088|NCT00824369|P6|Participant Flow|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469089|NCT00824369|P5|Participant Flow|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469090|NCT00824369|P4|Participant Flow|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469091|NCT00824369|P3|Participant Flow|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469092|NCT00824369|P2|Participant Flow|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469093|NCT00824369|P1|Participant Flow|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469094|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469095|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469096|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469097|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469098|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469099|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469100|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469101|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469102|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469103|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469104|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469105|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469106|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469107|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469108|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469109|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469110|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469111|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469112|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469113|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469114|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469115|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469116|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469117|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469118|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469119|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469120|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469121|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469122|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469123|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469124|NCT00824369|E6|Reported Event|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
469125|NCT00824369|E5|Reported Event|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
469126|NCT00824369|E4|Reported Event|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
469127|NCT00824369|E3|Reported Event|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
469128|NCT00824369|E2|Reported Event|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
469129|NCT00824369|E1|Reported Event|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
469130|NCT00824291|B3|Baseline|Total|Total of all reporting groups
469131|NCT00824291|B2|Baseline|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469132|NCT00824291|B1|Baseline|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469133|NCT00824291|P2|Participant Flow|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469134|NCT00824291|P1|Participant Flow|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469135|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469136|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469137|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469138|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469139|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469140|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469141|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469142|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469143|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469144|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469145|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469146|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469147|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469148|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469149|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469150|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469151|NCT00824291|E2|Reported Event|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
469152|NCT00824291|E1|Reported Event|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
469153|NCT00824265|B3|Baseline|Total|Total of all reporting groups
469154|NCT00824265|B2|Baseline|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469155|NCT00824265|B1|Baseline|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469156|NCT00824265|P2|Participant Flow|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469251|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469252|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
470199|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
469157|NCT00824265|P1|Participant Flow|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469158|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469159|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469160|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469161|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469162|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469163|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469164|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469165|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469166|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469167|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469168|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469169|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469253|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469302|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469170|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469171|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469172|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469173|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469174|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469175|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469176|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469177|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469178|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469179|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469180|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469181|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469182|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469183|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469254|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469303|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469184|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469185|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469186|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469187|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469188|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469189|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469190|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469191|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469192|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469193|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469194|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469195|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469196|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469197|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469255|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
470200|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
469198|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469199|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469200|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469201|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469202|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469203|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469204|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469205|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469206|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469207|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469208|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469209|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469210|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469211|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469256|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
470440|NCT00819832|B1|Baseline|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
469212|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469213|NCT00824265|E2|Reported Event|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469214|NCT00824265|E1|Reported Event|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
469215|NCT00824161|B1|Baseline|TAS-109|TAS-109 2.0 mg/m^2/day
469216|NCT00824161|P1|Participant Flow|TAS-109|TAS-109 2.0 mg/m^2/day
469217|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
469218|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
469219|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day Independent Assessment
469220|NCT00824161|E1|Reported Event|TAS-109|TAS-109 2.0 mg/m^2/day
469221|NCT00824070|B4|Baseline|Total|Total of all reporting groups
469222|NCT00824070|B3|Baseline|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
469223|NCT00824070|B2|Baseline|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
469224|NCT00824070|B1|Baseline|Besifloxacin|Besifloxacin ophthalmic suspension
469225|NCT00824070|P3|Participant Flow|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
469226|NCT00824070|P2|Participant Flow|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
469227|NCT00824070|P1|Participant Flow|Besifloxacin|Besifloxacin ophthalmic suspension
469228|NCT00824070|O3|Outcome|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
469229|NCT00824070|O2|Outcome|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
469230|NCT00824070|O1|Outcome|Besifloxacin|Besifloxacin ophthalmic suspension
469231|NCT00824070|E3|Reported Event|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
469232|NCT00824070|E2|Reported Event|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
469233|NCT00824070|E1|Reported Event|Besifloxacin|Besifloxacin ophthalmic suspension
469234|NCT00824044|B3|Baseline|Total|Total of all reporting groups
469235|NCT00824044|B2|Baseline|Escitalopram|The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
469236|NCT00824044|B1|Baseline|Cognitive Behavioral Therapy (CBT)|The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
469237|NCT00824044|P2|Participant Flow|Escitalopram|The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
469238|NCT00824044|P1|Participant Flow|Cognitive Behavioral Therapy (CBT)|The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
469239|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469240|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
469241|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469242|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469243|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469244|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
469245|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469246|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469247|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469248|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
469249|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469250|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469301|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
472100|NCT00816829|O1|Outcome|Placebo|Placebo
469257|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469258|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469259|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469260|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
469261|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469262|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469263|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469264|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
469265|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469266|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469267|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469268|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
469269|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469270|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469271|NCT00824044|O4|Outcome|Responders in Medication Arm|Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
469272|NCT00824044|O3|Outcome|Non Responders in Medication Arm|Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores
469273|NCT00824044|O2|Outcome|Responders in CBT Arm|Individuals randomized to the CBT group who did respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469274|NCT00824044|O1|Outcome|Non Responders in CBT Arm|Individuals randomized to the CBT group who did not respond to the CBT treatment. Response defined as greater than 50% reduction in HAM D scores
469275|NCT00824044|O2|Outcome|Escitalopram|Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
469276|NCT00824044|O1|Outcome|Cognitive Behavioral Therapy (CBT)|Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
469277|NCT00824044|E2|Reported Event|Escitalopram|The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
469278|NCT00824044|E1|Reported Event|Cognitive Behavioral Therapy (CBT)|The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
469279|NCT00824005|B3|Baseline|Total|Total of all reporting groups
469280|NCT00824005|B2|Baseline|Active Stem Cell Injections|Participants will receive active stem cell injections.
469281|NCT00824005|B1|Baseline|Placebo Injections|Participants will receive placebo injections.
469282|NCT00824005|P2|Participant Flow|Active Stem Cell Injections|Participants will receive active stem cell injections.
469283|NCT00824005|P1|Participant Flow|Placebo Injections|Participants will receive placebo injections.
469284|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469285|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469286|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469287|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469288|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469289|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469290|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469291|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469292|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469293|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469294|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469295|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469296|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469297|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469298|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469299|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469300|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469304|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469305|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469306|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469307|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469308|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469309|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469310|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
469311|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
469312|NCT00824005|E2|Reported Event|Active Stem Cell Injections|Participants received active stem cell injections.
469313|NCT00824005|E1|Reported Event|Placebo Injections|Participants received placebo injections.
469314|NCT00823979|B4|Baseline|Total|Total of all reporting groups
469315|NCT00823979|B3|Baseline|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469316|NCT00823979|B2|Baseline|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469317|NCT00823979|B1|Baseline|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469318|NCT00823979|P3|Participant Flow|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469319|NCT00823979|P2|Participant Flow|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469320|NCT00823979|P1|Participant Flow|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469321|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469322|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469323|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469324|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469325|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469326|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469327|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469328|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469329|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469330|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469611|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
470442|NCT00819832|P5|Participant Flow|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
469331|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469332|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469333|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469334|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469335|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469336|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469337|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469338|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469339|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469340|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469341|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469342|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469343|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469344|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469345|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469346|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469347|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469348|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469349|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469612|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469613|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
470551|NCT00819637|O3|Outcome|Levalbuterol 3 Doses|
469350|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469351|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469352|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469353|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469354|NCT00823979|E3|Reported Event|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469355|NCT00823979|E2|Reported Event|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469356|NCT00823979|E1|Reported Event|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
469357|NCT00823966|B1|Baseline|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
469358|NCT00823966|P1|Participant Flow|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
469359|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
469360|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
469361|NCT00823966|E1|Reported Event|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
469362|NCT00823901|B3|Baseline|Total|Total of all reporting groups
469363|NCT00823901|B2|Baseline|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
469364|NCT00823901|B1|Baseline|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
469365|NCT00823901|P2|Participant Flow|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
469366|NCT00823901|P1|Participant Flow|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
469367|NCT00823901|O2|Outcome|Placebo|Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks
469368|NCT00823901|O1|Outcome|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
469369|NCT00823901|E2|Reported Event|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
469370|NCT00823901|E1|Reported Event|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
469371|NCT00823836|B3|Baseline|Total|Total of all reporting groups
469372|NCT00823836|B2|Baseline|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469745|NCT00823043|O1|Outcome|Timolol Hemihydrate|
469373|NCT00823836|B1|Baseline|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469374|NCT00823836|P2|Participant Flow|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469375|NCT00823836|P1|Participant Flow|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469376|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469377|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469378|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469379|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469380|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469504|NCT00823719|B2|Baseline|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469381|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469382|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469383|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469384|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469385|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469386|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469387|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469388|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469505|NCT00823719|B1|Baseline|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469389|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469390|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469391|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469392|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469393|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469394|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469395|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469396|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469506|NCT00823719|P2|Participant Flow|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469746|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
469747|NCT00823043|O1|Outcome|Timolol Hemihydrate|
469397|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469398|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469399|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469400|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469401|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469402|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469403|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469404|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469405|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469406|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469407|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469408|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469409|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469410|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469411|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469412|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469413|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469414|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469415|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469416|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469417|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469418|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469419|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469420|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469421|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469422|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469423|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469424|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469425|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469426|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469427|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469428|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469429|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469430|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469431|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469432|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469433|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469434|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469435|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469436|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469437|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469438|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469439|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469440|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469441|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469442|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469443|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469444|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469445|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469446|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469447|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469448|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469449|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469450|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469451|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469452|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469453|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469454|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469455|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469456|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469457|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469458|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469459|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469460|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469461|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469462|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469463|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469464|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469465|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469466|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469467|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469468|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469469|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469470|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469471|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469472|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469473|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469474|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469475|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469476|NCT00823836|E2|Reported Event|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469507|NCT00823719|P1|Participant Flow|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469477|NCT00823836|E1|Reported Event|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
469478|NCT00823823|B3|Baseline|Total|Total of all reporting groups
469479|NCT00823823|B2|Baseline|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
469480|NCT00823823|B1|Baseline|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
469481|NCT00823823|P2|Participant Flow|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
469482|NCT00823823|P1|Participant Flow|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
469483|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
469484|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
469485|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
469486|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
469487|NCT00823823|E2|Reported Event|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
469488|NCT00823823|E1|Reported Event|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
469489|NCT00823797|B3|Baseline|Total|Total of all reporting groups
469490|NCT00823797|B2|Baseline|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469491|NCT00823797|B1|Baseline|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469492|NCT00823797|P2|Participant Flow|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469493|NCT00823797|P1|Participant Flow|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469494|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469495|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469496|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469497|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469498|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469499|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469500|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469501|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
469502|NCT00823797|E1|Reported Event|Treatment (Bendamustine Hydrochloride)|"Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Quality-of-Life Assessment: Ancillary studies"
469503|NCT00823719|B3|Baseline|Total|Total of all reporting groups
469608|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469508|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469509|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469510|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469511|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469512|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469513|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469514|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469515|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469516|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469517|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469518|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469519|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469520|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469521|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469522|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469523|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469524|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469525|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469526|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469527|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469609|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469748|NCT00823043|E1|Reported Event|Total Subjects Surveyed|
469528|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469529|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469530|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469531|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469532|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469533|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469534|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469535|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469536|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469537|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469749|NCT00822926|B3|Baseline|Total|Total of all reporting groups
469538|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469539|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469540|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469541|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469542|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469543|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469544|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469545|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469546|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469547|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469548|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469549|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469550|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469551|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469552|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469553|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469554|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469555|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469556|NCT00823719|E3|Reported Event|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469557|NCT00823719|E2|Reported Event|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
469610|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469558|NCT00823719|E1|Reported Event|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
469559|NCT00823615|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects
469560|NCT00823615|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.
469561|NCT00823615|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.
469562|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
469563|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
469564|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
469565|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
469566|NCT00823615|E2|Reported Event|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
469567|NCT00823615|E1|Reported Event|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
469568|NCT00823472|B3|Baseline|Total|Total of all reporting groups
469569|NCT00823472|B2|Baseline|Start rFSH on Cycle Day 5|
469570|NCT00823472|B1|Baseline|Start rFSH Cycle Day 2|
469571|NCT00823472|P2|Participant Flow|Start rFSH on Cycle Day 5|
469572|NCT00823472|P1|Participant Flow|Start rFSH Cycle Day 2|
469573|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
469574|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
469575|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
469576|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
469577|NCT00823472|E2|Reported Event|Start rFSH on Cycle Day 5|
469578|NCT00823472|E1|Reported Event|Start rFSH Cycle Day 2|
469579|NCT00823303|B3|Baseline|Total|Total of all reporting groups
469580|NCT00823303|B2|Baseline|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
469581|NCT00823303|B1|Baseline|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
469582|NCT00823303|P2|Participant Flow|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
469583|NCT00823303|P1|Participant Flow|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
469584|NCT00823303|O2|Outcome|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
469585|NCT00823303|O1|Outcome|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
469586|NCT00823303|E2|Reported Event|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
469587|NCT00823303|E1|Reported Event|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
469588|NCT00823264|B3|Baseline|Total|Total of all reporting groups
469589|NCT00823264|B2|Baseline|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc.
469590|NCT00823264|B1|Baseline|Control|Will not receive activated charcoal. Serum levels will be followed.
469591|NCT00823264|P2|Participant Flow|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc.
469592|NCT00823264|P1|Participant Flow|Control|Will not receive activated charcoal. Serum levels will be followed.
469593|NCT00823264|O2|Outcome|Multiple Doses of Activated Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
469594|NCT00823264|O1|Outcome|Control|Will not receive activated charcoal. Serum levels will be followed.
469595|NCT00823264|E2|Reported Event|Control|Will not receive activated charcoal. Serum levels will be followed.
469596|NCT00823264|E1|Reported Event|Multiple Doses of Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
469597|NCT00823212|B3|Baseline|Total|Total of all reporting groups
469598|NCT00823212|B2|Baseline|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469599|NCT00823212|B1|Baseline|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469600|NCT00823212|P2|Participant Flow|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469601|NCT00823212|P1|Participant Flow|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469602|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469603|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469604|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469605|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469606|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469607|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469614|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469615|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469616|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469617|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469618|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469619|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469620|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469621|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469622|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469623|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469624|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469625|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469626|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469627|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469628|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469629|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469630|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469631|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469632|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469633|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469634|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469635|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469636|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469637|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469638|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469639|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469640|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469641|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469642|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469643|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469644|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469645|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469646|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469647|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469648|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469649|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469650|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469651|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469652|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469653|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469654|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469655|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469656|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469657|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469658|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469659|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469660|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469661|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
470552|NCT00819637|O2|Outcome|Arformoterol 3 Doses|
469662|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469663|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469664|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469665|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469666|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469667|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469668|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469669|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469670|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469671|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469672|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469673|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469674|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469675|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469676|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469677|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469678|NCT00823212|O2|Outcome|PROMUS Element|PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
469679|NCT00823212|O1|Outcome|PROMUS|PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
469680|NCT00823212|E2|Reported Event|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
469681|NCT00823212|E1|Reported Event|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
469682|NCT00823199|B1|Baseline|Group 1|
469683|NCT00823199|P1|Participant Flow|Allopurinal Treatment|
469684|NCT00823199|O1|Outcome|Allopurinal Treatment|
469685|NCT00823199|O1|Outcome|Allopurinal Treatment|
469686|NCT00823199|O1|Outcome|Allopurinal Treatment|
469687|NCT00823199|E1|Reported Event|Group 1|
469688|NCT00823095|B1|Baseline|Group 1|Treatment
469689|NCT00823095|P1|Participant Flow|Topically Applied Nitric Oxide|Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
469690|NCT00823095|O1|Outcome|Treatment|reduction in bioburden as assessed by number of cfu's per cm2 on culture
469691|NCT00823095|O1|Outcome|Group 1|Treatment
469692|NCT00823095|E1|Reported Event|Group 1|Treatment
469693|NCT00823082|B3|Baseline|Total|Total of all reporting groups
469694|NCT00823082|B2|Baseline|Control Group|No preoperative ATIII supplementation administered
469695|NCT00823082|B1|Baseline|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469696|NCT00823082|P2|Participant Flow|Control Group|No preoperative ATIII supplementation administered
469697|NCT00823082|P1|Participant Flow|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469698|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469699|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469700|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469701|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469702|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469703|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469704|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469705|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469706|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469707|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469708|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469709|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469710|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469941|NCT00822328|B2|Baseline|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
469711|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469712|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469713|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469714|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469715|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469716|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469717|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469718|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469719|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469720|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469721|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469722|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469723|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469724|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469725|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469726|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
469727|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469728|NCT00823082|E2|Reported Event|Control Group|No preoperative ATII supplementation administered
469729|NCT00823082|E1|Reported Event|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
469730|NCT00823069|B1|Baseline|Perlane and Perlane-L|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
469731|NCT00823069|P1|Participant Flow|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
469732|NCT00823069|O2|Outcome|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
469733|NCT00823069|O1|Outcome|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
469734|NCT00823069|O1|Outcome|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
469735|NCT00823069|E2|Reported Event|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
469736|NCT00823069|E1|Reported Event|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
469737|NCT00823043|B1|Baseline|Total Subject Population|All subjects responding to survey
469738|NCT00823043|P2|Participant Flow|Timolol Maleate in Sorbate|Timolol maleate in sorbate 0.5% ophthalmic solution
469739|NCT00823043|P1|Participant Flow|Timolol Hemihydrate|Timolol hemihydrate 0.5% ophthalmic solution.
469740|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
469741|NCT00823043|O1|Outcome|Timolol Hemihydrate|
469742|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
469743|NCT00823043|O1|Outcome|Timolol Hemihydrate|
469744|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
469750|NCT00822926|B2|Baseline|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
469751|NCT00822926|B1|Baseline|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
469752|NCT00822926|P2|Participant Flow|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
469753|NCT00822926|P1|Participant Flow|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
469754|NCT00822926|O3|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
469755|NCT00822926|O2|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
469756|NCT00822926|O1|Outcome|Baseline|
469757|NCT00822926|O3|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
469758|NCT00822926|O2|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
469759|NCT00822926|O1|Outcome|Baseline|
469760|NCT00822926|O2|Outcome|Botox|Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
469761|NCT00822926|O1|Outcome|Placebo|Saline- Subcutaneous injection of saline into scar tissue
469762|NCT00822926|E2|Reported Event|Botox Then Placebo|Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
469763|NCT00822926|E1|Reported Event|Placebo Then Botox|Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
469764|NCT00822900|B3|Baseline|Total|Total of all reporting groups
469765|NCT00822900|B2|Baseline|Placebo|
469766|NCT00822900|B1|Baseline|Progesterone|
469767|NCT00822900|P2|Participant Flow|Placebo|
469768|NCT00822900|P1|Participant Flow|Progesterone|
469769|NCT00822900|O2|Outcome|Placebo|
469770|NCT00822900|O1|Outcome|Progesterone|
469771|NCT00822900|O2|Outcome|Placebo|
469772|NCT00822900|O1|Outcome|Progesterone|
469773|NCT00822900|O2|Outcome|Placebo|
469774|NCT00822900|O1|Outcome|Progesterone|
469775|NCT00822900|O2|Outcome|Placebo|
469776|NCT00822900|O1|Outcome|Progesterone|
469777|NCT00822900|O2|Outcome|Placebo|
469778|NCT00822900|O1|Outcome|Progesterone|
469779|NCT00822900|O2|Outcome|Placebo|
469780|NCT00822900|O1|Outcome|Progesterone|
469781|NCT00822900|O2|Outcome|Placebo|
469782|NCT00822900|O1|Outcome|Progesterone|
469783|NCT00822900|O2|Outcome|Placebo|
469784|NCT00822900|O1|Outcome|Progesterone|
469785|NCT00822900|O2|Outcome|Placebo|
469786|NCT00822900|O1|Outcome|Progesterone|
469787|NCT00822900|O2|Outcome|Placebo|
469788|NCT00822900|O1|Outcome|Progesterone|
469789|NCT00822900|O2|Outcome|Placebo|
469790|NCT00822900|O1|Outcome|Progesterone|
469791|NCT00822900|O2|Outcome|Placebo|
469792|NCT00822900|O1|Outcome|Progesterone|
469793|NCT00822900|E2|Reported Event|Placebo|
469794|NCT00822900|E1|Reported Event|Progesterone|
469795|NCT00822770|B1|Baseline|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
469796|NCT00822770|P1|Participant Flow|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~Thymoglobulin (ATG) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
469797|NCT00822770|O1|Outcome|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
469843|NCT00822523|P3|Participant Flow|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469942|NCT00822328|B1|Baseline|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
470553|NCT00819637|O1|Outcome|Arformoterol 1 Dose, Placebo 2 Doses|
469798|NCT00822770|E1|Reported Event|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
469799|NCT00822757|B3|Baseline|Total|Total of all reporting groups
469800|NCT00822757|B2|Baseline|Placebo|Saline placebo single dose at baseline.
469801|NCT00822757|B1|Baseline|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
469802|NCT00822757|P2|Participant Flow|Placebo|Saline placebo single dose at baseline.
469803|NCT00822757|P1|Participant Flow|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
469804|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
469805|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
469806|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
469807|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
469808|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
469809|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
469810|NCT00822757|E2|Reported Event|Placebo|Saline placebo single dose at baseline.
469811|NCT00822757|E1|Reported Event|V710 (60 mcg) Lyophilized|V710 (60 mcg)single dose at baseline.
469812|NCT00822692|B3|Baseline|Total|Total of all reporting groups
469813|NCT00822692|B2|Baseline|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
469814|NCT00822692|B1|Baseline|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
469815|NCT00822692|P2|Participant Flow|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
469816|NCT00822692|P1|Participant Flow|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
469817|NCT00822692|O2|Outcome|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
469818|NCT00822692|O1|Outcome|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
469819|NCT00822692|E2|Reported Event|Matched Placebo 2 Pills PO BID x 7 Days|matched placebo 2 pills PO BID x 7 days
469820|NCT00822692|E1|Reported Event|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|bactrim DS (800/160) two tablets PO BID x 7 days
469821|NCT00822679|B3|Baseline|Total|Total of all reporting groups
469822|NCT00822679|B2|Baseline|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
469823|NCT00822679|B1|Baseline|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
469824|NCT00822679|P2|Participant Flow|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
469825|NCT00822679|P1|Participant Flow|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
469826|NCT00822679|O2|Outcome|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
469827|NCT00822679|O1|Outcome|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
469828|NCT00822679|E2|Reported Event|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
469829|NCT00822679|E1|Reported Event|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
469830|NCT00822588|B3|Baseline|Total|Total of all reporting groups
469831|NCT00822588|B2|Baseline|No Sangvia|No autologous blood transfusion.
469832|NCT00822588|B1|Baseline|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
469833|NCT00822588|P2|Participant Flow|No Sangvia|No autologous blood transfusion.
469834|NCT00822588|P1|Participant Flow|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
469835|NCT00822588|O2|Outcome|No Sangvia|No autologous blood transfusion.
469836|NCT00822588|O1|Outcome|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
469837|NCT00822588|E2|Reported Event|No Sangvia|No autologous blood transfusion.
469838|NCT00822588|E1|Reported Event|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
469839|NCT00822523|B4|Baseline|Total|Total of all reporting groups
469840|NCT00822523|B3|Baseline|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469841|NCT00822523|B2|Baseline|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469842|NCT00822523|B1|Baseline|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469844|NCT00822523|P2|Participant Flow|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469845|NCT00822523|P1|Participant Flow|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469846|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469847|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469848|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469849|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469850|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469851|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469852|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469853|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469854|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469855|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469856|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469857|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469858|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469859|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469860|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469861|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469862|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469937|NCT00822354|O1|Outcome|Pre-treatment|
469938|NCT00822354|E2|Reported Event|Placebo|Subjects received placebo every other day for four weeks
469863|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469864|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469865|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469866|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469867|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469868|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469869|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469870|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469871|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469872|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469873|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469874|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469875|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469876|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469877|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469878|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469879|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469880|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469881|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469882|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469883|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469884|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469885|NCT00822523|E3|Reported Event|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
469886|NCT00822523|E2|Reported Event|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
469887|NCT00822523|E1|Reported Event|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
469888|NCT00822510|B3|Baseline|Total|Total of all reporting groups
469889|NCT00822510|B2|Baseline|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469939|NCT00822354|E1|Reported Event|Tadalafil|Subjects received tadalafil 20 mg every other day for four weeks.
469890|NCT00822510|B1|Baseline|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469891|NCT00822510|P2|Participant Flow|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469892|NCT00822510|P1|Participant Flow|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469893|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469894|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469895|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469896|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469897|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469898|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469899|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469900|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469901|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469902|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469903|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes.~Telephone delivered education only: Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation"
469904|NCT00822510|O1|Outcome|Telephone Interpersonal Counseling|"Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.~Telephone Interpersonal Counseling: Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy."
469905|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469906|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469907|NCT00822510|E2|Reported Event|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
469908|NCT00822510|E1|Reported Event|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
469909|NCT00822354|B3|Baseline|Total|Total of all reporting groups
469910|NCT00822354|B2|Baseline|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
469911|NCT00822354|B1|Baseline|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
469912|NCT00822354|P2|Participant Flow|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
469913|NCT00822354|P1|Participant Flow|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
469914|NCT00822354|O4|Outcome|Week 4 of Placebo|
469915|NCT00822354|O3|Outcome|Pre-placebo|
469916|NCT00822354|O2|Outcome|Week 4 of Treatment|
469917|NCT00822354|O1|Outcome|Pre-treatment|
469918|NCT00822354|O4|Outcome|Week 4 of Placebo|
469919|NCT00822354|O3|Outcome|Pre-placebo|
469920|NCT00822354|O2|Outcome|Week 4 of Treatment|
469921|NCT00822354|O1|Outcome|Pre-treatment|
469922|NCT00822354|O4|Outcome|Week 4 of Placebo|
469923|NCT00822354|O3|Outcome|Pre-placebo|
469924|NCT00822354|O2|Outcome|Week 4 of Treatment|
469925|NCT00822354|O1|Outcome|Pre-treatment|
469926|NCT00822354|O4|Outcome|Week 4 of Placebo|
469927|NCT00822354|O3|Outcome|Pre-placebo|
469928|NCT00822354|O2|Outcome|Week 4 of Treatment|
469929|NCT00822354|O1|Outcome|Pre-treatment|
469930|NCT00822354|O4|Outcome|Week 4 of Placebo|
469931|NCT00822354|O3|Outcome|Pre-placebo|
469932|NCT00822354|O2|Outcome|Week 4 of Treatment|
469933|NCT00822354|O1|Outcome|Pre-treatment|
469934|NCT00822354|O4|Outcome|Week 4 of Placebo|
469935|NCT00822354|O3|Outcome|Pre-placebo|
469936|NCT00822354|O2|Outcome|Week 4 of Treatment|
469943|NCT00822328|P2|Participant Flow|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
469944|NCT00822328|P1|Participant Flow|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
469945|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
469946|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
469947|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
469948|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
469949|NCT00822328|E2|Reported Event|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
469950|NCT00822328|E1|Reported Event|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
469951|NCT00822237|B3|Baseline|Total|Total of all reporting groups
469952|NCT00822237|B2|Baseline|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
469953|NCT00822237|B1|Baseline|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
469954|NCT00822237|P2|Participant Flow|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
469955|NCT00822237|P1|Participant Flow|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
469956|NCT00822237|O1|Outcome|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
469957|NCT00822237|E2|Reported Event|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
469958|NCT00822237|E1|Reported Event|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
469959|NCT00822185|B6|Baseline|Total|Total of all reporting groups
469960|NCT00822185|B5|Baseline|Placebo|A single dose of placebo was administered intravenously
469961|NCT00822185|B4|Baseline|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469962|NCT00822185|B3|Baseline|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469963|NCT00822185|B2|Baseline|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469964|NCT00822185|B1|Baseline|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469965|NCT00822185|P5|Participant Flow|Placebo|A single dose of placebo was administered intravenously
469966|NCT00822185|P4|Participant Flow|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469967|NCT00822185|P3|Participant Flow|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469968|NCT00822185|P2|Participant Flow|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469969|NCT00822185|P1|Participant Flow|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469970|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469971|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469972|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469973|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469974|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469975|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469976|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469977|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469978|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469979|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469980|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469981|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469982|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469983|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469984|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469985|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469986|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469987|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469988|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469989|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469990|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469991|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469992|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469993|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469994|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469995|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
469996|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
469997|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
469998|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
469999|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470000|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470001|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470002|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
470003|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470004|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470005|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470006|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
470007|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470008|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470009|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470010|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
470011|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470012|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470013|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470014|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
470015|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470016|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470017|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470018|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
470019|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
470020|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470021|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470022|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470023|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
470024|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
470025|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470026|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470027|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470028|NCT00822185|E5|Reported Event|Placebo|A single dose of placebo was administered intravenously
470029|NCT00822185|E4|Reported Event|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
470030|NCT00822185|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
470031|NCT00822185|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
470032|NCT00822185|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
470033|NCT00822172|B3|Baseline|Total|Total of all reporting groups
470055|NCT00822120|O1|Outcome|PET-negative: Continued ABVD After 2 Cycles of ABVD|Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles Continued ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470034|NCT00822172|B2|Baseline|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470035|NCT00822172|B1|Baseline|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470036|NCT00822172|P2|Participant Flow|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470037|NCT00822172|P1|Participant Flow|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470038|NCT00822172|O2|Outcome|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470039|NCT00822172|O1|Outcome|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470040|NCT00822172|E2|Reported Event|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470041|NCT00822172|E1|Reported Event|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
470042|NCT00822120|B3|Baseline|Total|Total of all reporting groups
470043|NCT00822120|B2|Baseline|HIV-positive: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470044|NCT00822120|B1|Baseline|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470045|NCT00822120|P6|Participant Flow|HIV-positive and PET-positive: BEACOPP Standard|Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
470046|NCT00822120|P5|Participant Flow|HIV-positive and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470047|NCT00822120|P4|Participant Flow|HIV-negative and PET-positive: BEACOPP Escalated|Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
470048|NCT00822120|P3|Participant Flow|HIV-negative and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470049|NCT00822120|P2|Participant Flow|HIV-positive: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470050|NCT00822120|P1|Participant Flow|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470051|NCT00822120|O3|Outcome|PET-positive: BEACOPP Standard|Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
470052|NCT00822120|O2|Outcome|PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470053|NCT00822120|O1|Outcome|Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470054|NCT00822120|O2|Outcome|PET-positive: BEACOPP Standard After 2 Cycles of ABVD|Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
470195|NCT00821236|P1|Participant Flow|Lasik for Treatment of Nearsightedness|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
470056|NCT00822120|O1|Outcome|HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap|HIV-positive patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
470057|NCT00822120|O1|Outcome|HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap|HIV-positive patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of standard BEACOPP: Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
470058|NCT00822120|O3|Outcome|HIV-negative and PET-positive: BEACOPP Escalated|Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
470059|NCT00822120|O2|Outcome|HIV-negative and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470060|NCT00822120|O1|Outcome|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470061|NCT00822120|O2|Outcome|PET-positive: BEACOPP Escalated After 2 Cycles of ABVD|Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
470062|NCT00822120|O1|Outcome|PET-negative: Continued ABVD After 2 Cycles of ABVD|Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles Continued ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470063|NCT00822120|O1|Outcome|HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy|HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
470064|NCT00822120|O1|Outcome|HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP|HIV-negative patients who are PET-positive are treated with 2 cycles of ABVD followed by escalated BEACOPP. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
470065|NCT00822120|O1|Outcome|HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap|HIV-negative patients treated with 2 cycles of ABVD followed by response-adapted therapy. Initial ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles. Interim PET-negative patients continue with 4 cycles of ABVD: Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles. Interim PET-positive patients receive 6 cycles of escalated BEACOPP: Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles.
470066|NCT00822120|E6|Reported Event|HIV-positive and PET-positive: BEACOPP Standard|Etoposide 100 mg/m^2 IV Days 1, 2, 3, Doxorubicin 25 mg/m^2 IV Day 1, Cyclophosphamide 650 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, Q 21 Days x 6 cycles
470067|NCT00822120|E5|Reported Event|HIV-positive and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470068|NCT00822120|E4|Reported Event|HIV-positive: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470069|NCT00822120|E3|Reported Event|HIV-negative and PET-positive: BEACOPP Escalated|Etoposide 200 mg/m^2 IV Days 1, 2, 3, Doxorubicin 35 mg/m^2 IV Day 1, Cyclophosphamide 1,250 mg/m^2 IV Day 1, Procarbzine 100 mg/m^2 PO Days 1-7, Prednisone 40 mg/m^2 PO Days 1-14, Bleomycin 10u/m^2 IV Day 8, Vincristine 1.4 mg/m^2 IV Day 8, G-CSF 5mcg/kg/day SQ Days 8-14, Q 21 Days x 6 cycles
470070|NCT00822120|E2|Reported Event|HIV-negative and PET-negative: Continued ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 4 cycles
470071|NCT00822120|E1|Reported Event|HIV-negative: Initial ABVD|Doxorubicin 25 mg/m^2 IV, Bleomycin 10u/m^2 IV, Vinblastine 6mg/m^2 IV, Dacarbazine 375 mg/m^2 IV Days 1,15 Q 28 Days x 2 cycles
470072|NCT00822094|B3|Baseline|Total|Total of all reporting groups
470196|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
470073|NCT00822094|B2|Baseline|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470074|NCT00822094|B1|Baseline|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470075|NCT00822094|P2|Participant Flow|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470076|NCT00822094|P1|Participant Flow|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470077|NCT00822094|O2|Outcome|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470078|NCT00822094|O1|Outcome|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470079|NCT00822094|O2|Outcome|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470080|NCT00822094|O1|Outcome|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470081|NCT00822094|O2|Outcome|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470082|NCT00822094|O1|Outcome|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470083|NCT00822094|O2|Outcome|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470084|NCT00822094|O1|Outcome|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470085|NCT00822094|O2|Outcome|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470086|NCT00822094|O1|Outcome|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470087|NCT00822094|O2|Outcome|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470088|NCT00822094|O1|Outcome|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470089|NCT00822094|E2|Reported Event|Salvage Therapy|First induction: Investigator’s choice salvage therapy administered according to local practice Second induction: Investigator’s choice salvage therapy administered according to local practice Consolidation(s): Investigator’s choice consolidation therapy administered according to local practice
470090|NCT00822094|E1|Reported Event|CPX-351|First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
470091|NCT00821964|B1|Baseline|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
470092|NCT00821964|P1|Participant Flow|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
470093|NCT00821964|O1|Outcome|Incidence of Reduction of TGF-beta Levels|Incidence of reduction of serum TGF-beta levels assessed by ELISA of at least 25% from baseline to week 13
470094|NCT00821964|O2|Outcome|HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24|Precursor frequency of HER2, IGFBP-2, MAGE3, Topo IIa Antigen - Baseline to Week 24
470095|NCT00821964|O1|Outcome|HER2, IGFBP-2, MAGE3, TopoIIa Antigen - Baseline to Week 13|Precursor frequency of HER2, IGFBP-2, MAGE3, Topo II-alpha antigens between baseline to Week 13
470151|NCT00821587|B1|Baseline|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
470096|NCT00821964|O1|Outcome|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
470097|NCT00821964|O1|Outcome|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
470098|NCT00821964|O1|Outcome|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
470099|NCT00821964|E1|Reported Event|Treatment (Biological Therapy, Chemo)|"Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.~imiquimod: Given topically~Abraxane: Given IV~laboratory biomarker analysis: Correlative studies~RNA analysis: Correlative studies~immunoenzyme technique: Correlative studies"
470100|NCT00821951|B1|Baseline|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
470101|NCT00821951|P1|Participant Flow|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
470102|NCT00821951|O1|Outcome|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
470103|NCT00821951|E1|Reported Event|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
470104|NCT00821886|B1|Baseline|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
470105|NCT00821886|P1|Participant Flow|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
470106|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
470107|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
470152|NCT00821587|P2|Participant Flow|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
470197|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
470554|NCT00819637|E3|Reported Event|Levalbuterol 3 Doses|
470108|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
470109|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
470110|NCT00821886|E1|Reported Event|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
470111|NCT00821873|B1|Baseline|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
470112|NCT00821873|P1|Participant Flow|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
470113|NCT00821873|O1|Outcome|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
470114|NCT00821873|E1|Reported Event|Adverse Events|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
470115|NCT00821821|B4|Baseline|Total|Total of all reporting groups
470116|NCT00821821|B3|Baseline|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
470117|NCT00821821|B2|Baseline|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
470118|NCT00821821|B1|Baseline|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
470119|NCT00821821|P3|Participant Flow|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
470120|NCT00821821|P2|Participant Flow|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
470121|NCT00821821|P1|Participant Flow|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
470122|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone:circa 2000mg / 72-hour infusion
470123|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone:circa 1000mg / 72-hour infusion
470124|NCT00821821|O3|Outcome|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
470125|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
470126|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
470127|NCT00821821|E3|Reported Event|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
470128|NCT00821821|E2|Reported Event|MCI-186 Cohort2|Edaravone: circa 2000mg / 72-hour infusion
470129|NCT00821821|E1|Reported Event|MCI-186 Cohort1|Edaravone: circa 1000mg / 72-hour infusion
470130|NCT00821678|B3|Baseline|Total|Total of all reporting groups
470131|NCT00821678|B2|Baseline|Arm 2 Treatment as Usual|Treatment as usual
470132|NCT00821678|B1|Baseline|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470133|NCT00821678|P2|Participant Flow|Arm 2 Treatment as Usual|Treatment as usual
470134|NCT00821678|P1|Participant Flow|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470135|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
470555|NCT00819637|E2|Reported Event|Arformoterol 3 Doses|
470136|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470137|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
470138|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470139|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
470140|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470141|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
470142|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470143|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
470144|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470145|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
470146|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470147|NCT00821678|E2|Reported Event|Arm 2 Treatment as Usual|Treatment as usual
470148|NCT00821678|E1|Reported Event|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
470149|NCT00821587|B3|Baseline|Total|Total of all reporting groups
470150|NCT00821587|B2|Baseline|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
470198|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
470153|NCT00821587|P1|Participant Flow|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
470154|NCT00821587|O2|Outcome|Cyclosporine (CsA)|Cyclosporine 2.0–4.0 mg/kg/day orally in two divided doses
470155|NCT00821587|O1|Outcome|Tacrolimus (TAC)|Tacrolimus 0.08–0.12 mg/kg/day orally in two divided doses
470156|NCT00821587|E2|Reported Event|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
470157|NCT00821587|E1|Reported Event|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
470158|NCT00821509|B4|Baseline|Total|Total of all reporting groups
470159|NCT00821509|B3|Baseline|Control|No change in hygiene behaviour
470160|NCT00821509|B2|Baseline|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
470161|NCT00821509|B1|Baseline|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
470162|NCT00821509|P3|Participant Flow|Control|No change in hygiene behaviour
470163|NCT00821509|P2|Participant Flow|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
470164|NCT00821509|P1|Participant Flow|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
470165|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
470166|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
470167|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
470168|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
470169|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
470170|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
470171|NCT00821509|E3|Reported Event|Control|No change in hygiene behaviour
470172|NCT00821509|E2|Reported Event|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
470173|NCT00821509|E1|Reported Event|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
470174|NCT00821431|B3|Baseline|Total|Total of all reporting groups
470175|NCT00821431|B2|Baseline|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
470176|NCT00821431|B1|Baseline|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
470177|NCT00821431|P2|Participant Flow|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
470178|NCT00821431|P1|Participant Flow|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
470190|NCT00821327|E1|Reported Event|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
470191|NCT00821236|B4|Baseline|Total|Total of all reporting groups
470179|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
470180|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
470181|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
470182|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
470183|NCT00821431|E2|Reported Event|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
470184|NCT00821431|E1|Reported Event|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
470185|NCT00821327|B1|Baseline|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
470186|NCT00821327|P1|Participant Flow|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
470187|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
470188|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
470189|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
470192|NCT00821236|B3|Baseline|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
470193|NCT00821236|B2|Baseline|AMO/VISX CustomVue|AMO/VISX CustomVue™
470194|NCT00821236|B1|Baseline|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
470201|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
470202|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
470203|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
470204|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
470205|NCT00821236|E3|Reported Event|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
470206|NCT00821236|E2|Reported Event|AMO/VISX CustomVue|AMO/VISX CustomVue™
470207|NCT00821236|E1|Reported Event|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
470208|NCT00821184|B3|Baseline|Total|Total of all reporting groups
470209|NCT00821184|B2|Baseline|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
470210|NCT00821184|B1|Baseline|Vesicare Alone|Vesicare alone in treatment of incontinence
470211|NCT00821184|P2|Participant Flow|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
470212|NCT00821184|P1|Participant Flow|Vesicare Alone|Vesicare alone in treatment of incontinence
470213|NCT00821184|O2|Outcome|Vesicare/Behavioral Modification|"Vesicare plus behavioral modification~Vesicare (solifenacin) plus behavioral modification: 5 mg dose po once daily plus behavioral modification"
470214|NCT00821184|O1|Outcome|Vesicare|"Vesicare alone~Vesicare (solifenacin): 5mg po qd"
470215|NCT00821184|O2|Outcome|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
470216|NCT00821184|O1|Outcome|Vesicare Alone|Vesicare alone in treatment of incontinence
470217|NCT00821184|E2|Reported Event|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
470218|NCT00821184|E1|Reported Event|Vesicare Alone|Vesicare alone in treatment of incontinence
470219|NCT00821119|B3|Baseline|Total|Total of all reporting groups
470220|NCT00821119|B2|Baseline|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
470221|NCT00821119|B1|Baseline|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
470222|NCT00821119|P2|Participant Flow|Nasal Intermittent Positive Pressure Ventilation (NIPPV)|Nasal intermittent positive pressure ventilation as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life.We used a time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 – 6 cm H2O, inspiratory time (Ti) of 0.4 – 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
470223|NCT00821119|P1|Participant Flow|Nasal Continuous Positive Airway Pressure (NCPAP)|Continuous nasal positive airway pressure as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life. Infants randomized to the NCPAP group were initiated on a pressure of 5 – 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
470224|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
470225|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
470226|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
470227|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
470228|NCT00821119|O2|Outcome|NIPPV|preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
470229|NCT00821119|O1|Outcome|NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
470230|NCT00821119|E2|Reported Event|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
470231|NCT00821119|E1|Reported Event|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
470232|NCT00821093|B3|Baseline|Total|Total of all reporting groups
470233|NCT00821093|B2|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470234|NCT00821093|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470235|NCT00821093|P2|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470236|NCT00821093|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470237|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470238|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470239|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470240|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470241|NCT00821093|E2|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470242|NCT00821093|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
470243|NCT00821041|B3|Baseline|Total|Total of all reporting groups
470244|NCT00821041|B2|Baseline|Cognitive Behavioral Therapy|
470245|NCT00821041|B1|Baseline|Waiting List Control|
470246|NCT00821041|P2|Participant Flow|Cognitive Behavioral Therapy|
470247|NCT00821041|P1|Participant Flow|Waiting List Control|
470248|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
470249|NCT00821041|O1|Outcome|Waiting List Control|
470250|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
470251|NCT00821041|O1|Outcome|Waiting List Control|
470252|NCT00821041|E2|Reported Event|Cognitive Behavioral Therapy|
470253|NCT00821041|E1|Reported Event|Waiting List Control|
470254|NCT00820898|B1|Baseline|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
470255|NCT00820898|P1|Participant Flow|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
470256|NCT00820898|O6|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
470257|NCT00820898|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
470258|NCT00820898|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
470556|NCT00819637|E1|Reported Event|Arformoterol 1 Dose, Placebo 2 Doses|
470259|NCT00820898|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
470260|NCT00820898|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
470261|NCT00820898|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
470262|NCT00820898|O1|Outcome|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
470263|NCT00820898|E1|Reported Event|Gemcitabine|Gemcitabine 800mg/m2 I.V. Days 1 and 8 every 21 days (one cycle)
470264|NCT00820872|B1|Baseline|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
470265|NCT00820872|P1|Participant Flow|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
470266|NCT00820872|O1|Outcome|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
470267|NCT00820872|E1|Reported Event|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
470268|NCT00820755|B1|Baseline|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
470269|NCT00820755|P3|Participant Flow|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470270|NCT00820755|P2|Participant Flow|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470271|NCT00820755|P1|Participant Flow|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
470272|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470273|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470333|NCT00820573|O1|Outcome|Placebo|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin.
470557|NCT00819585|B8|Baseline|Total|Total of all reporting groups
470274|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470275|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470276|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
470277|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470278|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470279|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
470280|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470281|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470282|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470283|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470284|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470285|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470286|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470287|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
470288|NCT00820755|E3|Reported Event|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
470289|NCT00820755|E2|Reported Event|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression after combination therapy, they administered with cetuximab 500 mg/m^2 intravenously for 2 weeks, for up to PD, development of unacceptable toxicities, or withdrawal of consent after the end of combination therapy.
470334|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
470441|NCT00819832|P6|Participant Flow|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
470290|NCT00820755|E1|Reported Event|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
470291|NCT00820664|B4|Baseline|Total|Total of all reporting groups
470292|NCT00820664|B3|Baseline|Placebo|
470293|NCT00820664|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
470294|NCT00820664|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
470295|NCT00820664|P3|Participant Flow|Placebo|
470296|NCT00820664|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
470297|NCT00820664|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
470298|NCT00820664|O3|Outcome|Placebo|
470299|NCT00820664|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
470300|NCT00820664|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
470301|NCT00820664|E3|Reported Event|Placebo|
470302|NCT00820664|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
470303|NCT00820664|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
470304|NCT00820612|B3|Baseline|Total|Total of all reporting groups
470305|NCT00820612|B2|Baseline|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470306|NCT00820612|B1|Baseline|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470307|NCT00820612|P2|Participant Flow|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470308|NCT00820612|P1|Participant Flow|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470309|NCT00820612|O2|Outcome|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470310|NCT00820612|O1|Outcome|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470311|NCT00820612|E2|Reported Event|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470312|NCT00820612|E1|Reported Event|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
470313|NCT00820573|B5|Baseline|Total|Total of all reporting groups
470314|NCT00820573|B4|Baseline|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
470315|NCT00820573|B3|Baseline|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
470316|NCT00820573|B2|Baseline|Metformin|all subjects after receiving 6 weeks of metformin therapy
470317|NCT00820573|B1|Baseline|Placebo|all subjects after 6 weeks of placebo therapy
470318|NCT00820573|P4|Participant Flow|Sitagliptin Plus Metformin, Sitagliptin, Placebo,Metformin|Sequence as described, starting with combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily placebo therapy for 6 weeks and finally metforminfor 6 weeks.
470319|NCT00820573|P3|Participant Flow|Metformin, Sitagliptin Plus Metformin, Sitagliptin,Placebo|Sequence as described, starting with metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily followed by placebo therapy for the final 6 weeks
470320|NCT00820573|P2|Participant Flow|Sitagliptin, Metformin, Sitagliptin Plus Metformin, Placebo|Sequence as described, starting with sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks and then placebo therapy for the final 6 weeks
470321|NCT00820573|P1|Participant Flow|Placebo,Sitagliptin,Metformin and Sitagliptin Plus Metformin|Sequence as described, starting placebo therapy for 6 weeks,followed by sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks and the combination sitagliptn plus metformin for the final 6 weeks
470322|NCT00820573|O4|Outcome|Sitagliptin+Metformin|placebo for 6 weeks
470323|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin~Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
470324|NCT00820573|O2|Outcome|Metformin|"Metformin~Metformin : tablet, 1000 mg/ bid, 6 weeks"
470325|NCT00820573|O1|Outcome|Placebo|"Sitagliptin~Sitagliptin : tablet, 100 mg/day, 6 weeks"
470326|NCT00820573|O4|Outcome|Sitagliptin + Metformin|placebo for 6 weeks
470327|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin~Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
470328|NCT00820573|O2|Outcome|Metformin|"Metformin~Metformin : tablet, 1000 mg/ bid, 6 weeks"
470329|NCT00820573|O1|Outcome|Placebo|"Sitagliptin~Sitagliptin : tablet, 100 mg/day, 6 weeks"
470330|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
470331|NCT00820573|O3|Outcome|Sitagliptin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
470332|NCT00820573|O2|Outcome|Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
470434|NCT00819832|B7|Baseline|Total|Total of all reporting groups
470335|NCT00820573|O3|Outcome|Sitagliptin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
470336|NCT00820573|O2|Outcome|Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
470337|NCT00820573|O1|Outcome|Placebo|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
470338|NCT00820573|E4|Reported Event|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
470339|NCT00820573|E3|Reported Event|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
470340|NCT00820573|E2|Reported Event|Metformin|all subjects after receiving 6 weeks of metformin therapy
470341|NCT00820573|E1|Reported Event|Placebo|all subjects after 6 weeks of placebo therapy
470342|NCT00820534|B3|Baseline|Total|Total of all reporting groups
470343|NCT00820534|B2|Baseline|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
470344|NCT00820534|B1|Baseline|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
470345|NCT00820534|P2|Participant Flow|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
470346|NCT00820534|P1|Participant Flow|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
470347|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
470348|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
470349|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
470350|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
470351|NCT00820534|E2|Reported Event|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
470352|NCT00820534|E1|Reported Event|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
470353|NCT00820443|B1|Baseline|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
470354|NCT00820443|P1|Participant Flow|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
470355|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
470356|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component"
470357|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
470358|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
470359|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
470360|NCT00820443|E1|Reported Event|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
470361|NCT00820248|B3|Baseline|Total|Total of all reporting groups
470362|NCT00820248|B2|Baseline|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470363|NCT00820248|B1|Baseline|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470364|NCT00820248|P2|Participant Flow|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470365|NCT00820248|P1|Participant Flow|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470366|NCT00820248|O2|Outcome|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470367|NCT00820248|O1|Outcome|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470435|NCT00819832|B6|Baseline|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
470436|NCT00819832|B5|Baseline|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
470437|NCT00819832|B4|Baseline|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
470368|NCT00820248|O2|Outcome|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470369|NCT00820248|O1|Outcome|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470370|NCT00820248|E2|Reported Event|Panitumumab|"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.~panitumumab: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470371|NCT00820248|E1|Reported Event|Cisplatin|"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.~cisplatin: Given IV~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~intensity-modulated radiation therapy: Patients undergo radiotherapy"
470372|NCT00820222|B3|Baseline|Total|Total of all reporting groups
470373|NCT00820222|B2|Baseline|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470374|NCT00820222|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470375|NCT00820222|P2|Participant Flow|Trastuzumab Plus Capecitabine|Participants received an intravenous (IV) infusion of trastuzumab 8 mg/kilogram (kg) on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470376|NCT00820222|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470377|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470378|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470379|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470380|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470381|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470382|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470438|NCT00819832|B3|Baseline|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
470439|NCT00819832|B2|Baseline|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
470383|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470384|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470385|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470386|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470387|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470388|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470389|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470390|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470391|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470392|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470393|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470394|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470395|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470396|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
472101|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
470397|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470398|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470399|NCT00820222|E2|Reported Event|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470400|NCT00820222|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
470401|NCT00819910|B5|Baseline|Total|Total of all reporting groups
470402|NCT00819910|B4|Baseline|Placebo Therapy Daily|Placebo (Rosiglitazone 8mg once daily) and placebo (Fenofibrate 145 mg once daily) for 12 weeks
470403|NCT00819910|B3|Baseline|Rosiglitazone + Placebo|Rosiglitazone 8mg once daily and Placebo ( Fenofibrate 145mg once daily)
470404|NCT00819910|B2|Baseline|Fenofibrate + Placebo|Fenofibrate 145mg once daily for 12 weeks and Placebo (Rosiglitazone 8mg once daily)
470405|NCT00819910|B1|Baseline|Rosiglitazone/Fenofibrate Therapy Daily|Rosiglitazone 8mg once daily and Fenofibrate 145mg once daily for 12 weeks
470406|NCT00819910|P4|Participant Flow|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470407|NCT00819910|P3|Participant Flow|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
470408|NCT00819910|P2|Participant Flow|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
470409|NCT00819910|P1|Participant Flow|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470410|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470411|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
470412|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
470413|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470414|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470415|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
470416|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
470417|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470418|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470419|NCT00819910|O3|Outcome|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
470420|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
470421|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470422|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470423|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
470424|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
470425|NCT00819910|O1|Outcome|Rosiglitazone and Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470426|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470427|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
470428|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
470429|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
470430|NCT00819910|E4|Reported Event|Placebo Therapy Daily|"Rosiglitazone (placebo) once daily and Fenofibrate (placebo)once daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
470431|NCT00819910|E3|Reported Event|Fenofibrate + Placebo|"Fenofibrate 145 mg po daily for 12 weeks= Placebo (Rosiglitazone 8mg po daily)~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
470432|NCT00819910|E2|Reported Event|Rosiglitazone + Placebo|"Rosiglitazone 8mg po daily + Placebo (Fenofibrate 145 mg po daily) for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
470433|NCT00819910|E1|Reported Event|Rosiglitazone/Fenofibrate Therapy Daily|"Rosiglitazone 8mg po daily + Fenofibrate 145 mg po daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
470443|NCT00819832|P4|Participant Flow|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
470444|NCT00819832|P3|Participant Flow|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
470445|NCT00819832|P2|Participant Flow|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
470446|NCT00819832|P1|Participant Flow|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
470447|NCT00819832|O6|Outcome|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
470448|NCT00819832|O5|Outcome|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
470449|NCT00819832|O4|Outcome|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
470450|NCT00819832|O3|Outcome|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
470451|NCT00819832|O2|Outcome|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
470452|NCT00819832|O1|Outcome|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
470453|NCT00819832|E6|Reported Event|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
470454|NCT00819832|E5|Reported Event|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
470455|NCT00819832|E4|Reported Event|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
470456|NCT00819832|E3|Reported Event|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
470457|NCT00819832|E2|Reported Event|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
470458|NCT00819832|E1|Reported Event|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
470459|NCT00819780|B3|Baseline|Total|Total of all reporting groups
470460|NCT00819780|B2|Baseline|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470461|NCT00819780|B1|Baseline|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470462|NCT00819780|P2|Participant Flow|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
470463|NCT00819780|P1|Participant Flow|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU; 2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
470464|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470465|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470466|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470467|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470468|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470469|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470470|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470471|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470472|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470473|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470474|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470475|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470476|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470477|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470478|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470479|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470480|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470481|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470482|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470483|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470484|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470485|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470486|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470487|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470488|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470489|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470490|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470491|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470492|NCT00819780|E2|Reported Event|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470493|NCT00819780|E1|Reported Event|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
470494|NCT00819767|B3|Baseline|Total|Total of all reporting groups
470495|NCT00819767|B2|Baseline|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470496|NCT00819767|B1|Baseline|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470497|NCT00819767|P2|Participant Flow|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470498|NCT00819767|P1|Participant Flow|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470499|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470500|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470501|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470502|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470503|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
472102|NCT00816829|O1|Outcome|Placebo|Placebo
470504|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470505|NCT00819767|E2|Reported Event|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470506|NCT00819767|E1|Reported Event|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
470507|NCT00819741|B3|Baseline|Total|Total of all reporting groups
470508|NCT00819741|B2|Baseline|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470509|NCT00819741|B1|Baseline|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470510|NCT00819741|P2|Participant Flow|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470511|NCT00819741|P1|Participant Flow|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470512|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470513|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470514|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470515|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470516|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470517|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470518|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470519|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470520|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470521|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470522|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470523|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470785|NCT00819247|B2|Baseline|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470524|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470525|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470526|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470527|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470528|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470529|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470530|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470531|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470532|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470533|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470534|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470535|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470536|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470537|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470538|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470539|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470540|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470541|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470542|NCT00819741|E2|Reported Event|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
470543|NCT00819741|E1|Reported Event|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
470544|NCT00819637|B4|Baseline|Total|Total of all reporting groups
470545|NCT00819637|B3|Baseline|Levalbuterol 3 Doses|
470546|NCT00819637|B2|Baseline|Arformoterol 3 Doses|
470547|NCT00819637|B1|Baseline|Arformoterol 1 Dose, Placebo 2 Doses|
470548|NCT00819637|P3|Participant Flow|Levalbuterol 3 Doses|
470549|NCT00819637|P2|Participant Flow|Arformoterol 3 Doses|
470550|NCT00819637|P1|Participant Flow|Arformoterol 1 Dose, Placebo 2 Doses|
470558|NCT00819585|B7|Baseline|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470559|NCT00819585|B6|Baseline|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470560|NCT00819585|B5|Baseline|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470561|NCT00819585|B4|Baseline|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470562|NCT00819585|B3|Baseline|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470563|NCT00819585|B2|Baseline|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470564|NCT00819585|B1|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470565|NCT00819585|P7|Participant Flow|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470566|NCT00819585|P6|Participant Flow|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470567|NCT00819585|P5|Participant Flow|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470568|NCT00819585|P4|Participant Flow|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470569|NCT00819585|P3|Participant Flow|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470570|NCT00819585|P2|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470571|NCT00819585|P1|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470572|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470573|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470786|NCT00819247|B1|Baseline|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470574|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470575|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470576|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470577|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470578|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470579|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470580|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470581|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470582|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470583|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470584|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470585|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470586|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470587|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470588|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470589|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470787|NCT00819247|P3|Participant Flow|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
471138|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
470590|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470591|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470592|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470593|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470594|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470595|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470596|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470597|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470598|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470599|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470600|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470601|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470602|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470603|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470604|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470605|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470788|NCT00819247|P2|Participant Flow|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
471139|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
470606|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470607|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470608|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470609|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470610|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470611|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470612|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470613|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470614|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470615|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470616|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470617|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470618|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470619|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470620|NCT00819585|E7|Reported Event|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470621|NCT00819585|E6|Reported Event|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470789|NCT00819247|P1|Participant Flow|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470622|NCT00819585|E5|Reported Event|Canakinumab 300mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
470623|NCT00819585|E4|Reported Event|Canakinumab 200mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470624|NCT00819585|E3|Reported Event|Canakinumab 100mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470625|NCT00819585|E2|Reported Event|Canakinumab 50mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470626|NCT00819585|E1|Reported Event|Canakinumab 25mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
470627|NCT00819507|B1|Baseline|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
470628|NCT00819507|P1|Participant Flow|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
470629|NCT00819507|O1|Outcome|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
470630|NCT00819507|O1|Outcome|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
470631|NCT00819507|E1|Reported Event|Vanos Cream|"glucocorticoid cream~Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks"
470632|NCT00819403|B3|Baseline|Total|Total of all reporting groups
470633|NCT00819403|B2|Baseline|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
470634|NCT00819403|B1|Baseline|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
470635|NCT00819403|P2|Participant Flow|Simvastatin/Ezetimibe Then Simvastatin|Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
470636|NCT00819403|P1|Participant Flow|Simvastatin Then Simvastatin/Ezetimibe|"Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily~Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied."
470637|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Ezetimibe/simvastatin 10/40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
470638|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
470639|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
470640|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
470641|NCT00819403|E2|Reported Event|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
470642|NCT00819403|E1|Reported Event|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
470643|NCT00819390|B5|Baseline|Total|Total of all reporting groups
470644|NCT00819390|B4|Baseline|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470645|NCT00819390|B3|Baseline|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470646|NCT00819390|B2|Baseline|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470647|NCT00819390|B1|Baseline|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470648|NCT00819390|P4|Participant Flow|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470649|NCT00819390|P3|Participant Flow|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470650|NCT00819390|P2|Participant Flow|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470651|NCT00819390|P1|Participant Flow|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470652|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470653|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470654|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470655|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470656|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470657|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470658|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470659|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470660|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470661|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470662|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470663|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470664|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470665|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470666|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470667|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470668|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470790|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470669|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470670|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470671|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470672|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470673|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470674|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470675|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470676|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470677|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470678|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470679|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470680|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470681|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470682|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470683|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470684|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470685|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470686|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470687|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470688|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470791|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470689|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470690|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470691|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470692|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470693|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470694|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470695|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470696|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470697|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470698|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470699|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470700|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470701|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470702|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470703|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470704|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470705|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470706|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470707|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470708|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470792|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470709|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470710|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470711|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470712|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470713|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470714|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470715|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470716|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470717|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470718|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470719|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470720|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470721|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470722|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470723|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470724|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470725|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470726|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470727|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470728|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470793|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470729|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470730|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470731|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470732|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470733|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470734|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470735|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470736|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470737|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470738|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470739|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470740|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470741|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470742|NCT00819390|O2|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470743|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470744|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470745|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470746|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470747|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470748|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470794|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470749|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470750|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470751|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470752|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470753|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470754|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470755|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470756|NCT00819390|E4|Reported Event|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470757|NCT00819390|E3|Reported Event|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470758|NCT00819390|E2|Reported Event|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470759|NCT00819390|E1|Reported Event|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
470760|NCT00819286|B3|Baseline|Total|Total of all reporting groups
470761|NCT00819286|B2|Baseline|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
470762|NCT00819286|B1|Baseline|Wire (Control)|patients will have their sternum closed using stainless steel wires.
470763|NCT00819286|P2|Participant Flow|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
470764|NCT00819286|P1|Participant Flow|Wire (Control)|patients will have their sternum closed using stainless steel wires.
470765|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
470766|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
470767|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
470768|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
470769|NCT00819286|E2|Reported Event|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
470770|NCT00819286|E1|Reported Event|Wire (Control)|patients will have their sternum closed using stainless steel wires.
470771|NCT00819260|B1|Baseline|All Participants|Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
470772|NCT00819260|P1|Participant Flow|All Participants|All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.
470773|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
470774|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
470775|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
470776|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
470777|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
470778|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
470779|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
470780|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
470781|NCT00819260|E2|Reported Event|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
470782|NCT00819260|E1|Reported Event|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
470783|NCT00819247|B4|Baseline|Total|Total of all reporting groups
470784|NCT00819247|B3|Baseline|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470795|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470796|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470797|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470798|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470799|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470800|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470801|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470802|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470803|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470804|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470805|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470806|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470807|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470808|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470809|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470810|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470811|NCT00819247|E3|Reported Event|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
470812|NCT00819247|E2|Reported Event|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470813|NCT00819247|E1|Reported Event|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
470814|NCT00819234|B1|Baseline|All Participants|All participants who completed the original study and chose to enter the extension study.
470815|NCT00819234|P10|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470816|NCT00819234|P9|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470817|NCT00819234|P8|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470818|NCT00819234|P7|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
470819|NCT00819234|P6|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
470820|NCT00819234|P5|Participant Flow|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
470821|NCT00819234|P4|Participant Flow|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470822|NCT00819234|P3|Participant Flow|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470823|NCT00819234|P2|Participant Flow|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
471140|NCT00819091|E2|Reported Event|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
470824|NCT00819234|P1|Participant Flow|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470825|NCT00819234|O6|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470826|NCT00819234|O5|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470827|NCT00819234|O4|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470828|NCT00819234|O3|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470829|NCT00819234|O2|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470830|NCT00819234|O1|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470831|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470832|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470833|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470834|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470835|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470836|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470837|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470838|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470839|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470840|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470841|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470842|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470843|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470844|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470845|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470846|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470847|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470848|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470849|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470850|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470851|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470852|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470853|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470854|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470855|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470856|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470857|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470858|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470859|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470860|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470861|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470862|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470863|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470864|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470865|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470866|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470867|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470868|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470869|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470870|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470871|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470872|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470873|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470874|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470875|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470876|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470877|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470878|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470879|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470880|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470881|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470882|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470883|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470884|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470885|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470886|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470887|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470888|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470889|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470890|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470891|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470892|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470893|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470894|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470895|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470896|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470897|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470898|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
471141|NCT00819091|E1|Reported Event|Placebo|Matching placebo tablet taken orally once daily
470899|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470900|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470901|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470902|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470903|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
470904|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470905|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470906|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470907|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470908|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470909|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470910|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470911|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470912|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470913|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
470914|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470915|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470916|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470965|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
471142|NCT00819052|B3|Baseline|Total|Total of all reporting groups
470917|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470918|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470919|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470920|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470921|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470922|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470923|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470924|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470925|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470926|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470927|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470928|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470929|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470930|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470931|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470932|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470933|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470934|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470935|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470936|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed, to minimize nausea and/or vomiting.
470937|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470938|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470939|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470940|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470941|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470942|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470943|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
470944|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470945|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470946|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470947|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
470948|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470949|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470950|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470951|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
470952|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470953|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470954|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470955|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
470956|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470957|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470958|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
470959|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
470960|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
470961|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
470962|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
470963|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
470964|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
471143|NCT00819052|B2|Baseline|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
470966|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470967|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
470968|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
470969|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
470970|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470971|NCT00819234|E10|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470972|NCT00819234|E9|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470973|NCT00819234|E8|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
470974|NCT00819234|E7|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470975|NCT00819234|E6|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470976|NCT00819234|E5|Reported Event|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
470977|NCT00819234|E4|Reported Event|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470978|NCT00819234|E3|Reported Event|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470979|NCT00819234|E2|Reported Event|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
470980|NCT00819234|E1|Reported Event|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
470981|NCT00819182|B4|Baseline|Total|Total of all reporting groups
470982|NCT00819182|B3|Baseline|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
470983|NCT00819182|B2|Baseline|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
470984|NCT00819182|B1|Baseline|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
470985|NCT00819182|P3|Participant Flow|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
470986|NCT00819182|P2|Participant Flow|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
471090|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
470987|NCT00819182|P1|Participant Flow|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
470988|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
470989|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
470990|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
470991|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
470992|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
470993|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
470994|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
470995|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
470996|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
470997|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
470998|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
470999|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
471000|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
471001|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
471002|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
471003|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
471004|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
471005|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
471006|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
471007|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
471008|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
471009|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
471010|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
471011|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
471012|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
471013|NCT00819182|E3|Reported Event|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
471014|NCT00819182|E2|Reported Event|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
471015|NCT00819182|E1|Reported Event|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
471016|NCT00819156|B7|Baseline|Total|Total of all reporting groups
471017|NCT00819156|B6|Baseline|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471018|NCT00819156|B5|Baseline|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471019|NCT00819156|B4|Baseline|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471020|NCT00819156|B3|Baseline|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471021|NCT00819156|B2|Baseline|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471022|NCT00819156|B1|Baseline|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471023|NCT00819156|P6|Participant Flow|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471024|NCT00819156|P5|Participant Flow|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471025|NCT00819156|P4|Participant Flow|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471026|NCT00819156|P3|Participant Flow|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471027|NCT00819156|P2|Participant Flow|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471028|NCT00819156|P1|Participant Flow|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471029|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471030|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471031|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471032|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471033|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471034|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471035|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471036|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471037|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471038|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471039|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471040|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471041|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471042|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471043|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471044|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471045|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471046|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471047|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471048|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471049|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471050|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471051|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471052|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471053|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471054|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471055|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471136|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471056|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471057|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471058|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471059|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471060|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471061|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471062|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471063|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471064|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471065|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471066|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471067|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471068|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471069|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471070|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471071|NCT00819156|O5|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471072|NCT00819156|O4|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471073|NCT00819156|O3|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471074|NCT00819156|O2|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471075|NCT00819156|O1|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471076|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471077|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471078|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471079|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471080|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471081|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471082|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471083|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471084|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471085|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471086|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471087|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471088|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471089|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471137|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471412|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
471091|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471092|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471093|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471094|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471095|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471096|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471097|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471098|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471099|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471100|NCT00819156|O3|Outcome|Maintenance Dose of 160 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.
471101|NCT00819156|O2|Outcome|Maintenance Dose of 120 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined.
471102|NCT00819156|O1|Outcome|Maintenance Dose of 80 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined.
471103|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471104|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471105|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471106|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471107|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471108|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471109|NCT00819156|E6|Reported Event|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471110|NCT00819156|E5|Reported Event|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471111|NCT00819156|E4|Reported Event|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471112|NCT00819156|E3|Reported Event|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
471113|NCT00819156|E2|Reported Event|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
471114|NCT00819156|E1|Reported Event|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
471115|NCT00819091|B3|Baseline|Total|Total of all reporting groups
471116|NCT00819091|B2|Baseline|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471117|NCT00819091|B1|Baseline|Placebo|Matching placebo tablet taken orally once daily
471118|NCT00819091|P2|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471119|NCT00819091|P1|Participant Flow|Placebo|Matching placebo tablet taken orally once daily
471120|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471121|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471122|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471123|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471124|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471125|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471126|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471127|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471128|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471129|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471130|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471131|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471132|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471133|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471134|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
471135|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
471144|NCT00819052|B1|Baseline|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471145|NCT00819052|P2|Participant Flow|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471146|NCT00819052|P1|Participant Flow|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471147|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471148|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471149|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471150|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471151|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471152|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471153|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471154|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471155|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471156|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471157|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471158|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471159|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471160|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471161|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471162|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471163|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471164|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471165|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471166|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471167|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471168|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471169|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471170|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471171|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471172|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471173|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471174|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471175|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471176|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471177|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471178|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471179|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471180|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471181|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471182|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471183|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471184|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471185|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471186|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471187|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471188|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471189|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471190|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471191|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471192|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471193|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471194|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471195|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471196|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471197|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471198|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471199|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471200|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471201|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471413|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
471202|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471203|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471204|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471205|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471206|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471207|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471208|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471209|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471210|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471211|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471212|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471213|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471214|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471215|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471216|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471217|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471218|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471219|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471220|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471221|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471222|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471223|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471224|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
471225|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
471226|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
471227|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471228|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471229|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471230|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471231|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471232|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471233|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471234|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471235|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471236|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471237|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471238|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471239|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471240|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471241|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471242|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471243|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471244|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471245|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471246|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471247|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471248|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471249|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471250|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471251|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471252|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471253|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471254|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471255|NCT00819052|E2|Reported Event|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
471256|NCT00819052|E1|Reported Event|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
471257|NCT00819039|B4|Baseline|Total|Total of all reporting groups
471258|NCT00819039|B3|Baseline|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471259|NCT00819039|B2|Baseline|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471260|NCT00819039|B1|Baseline|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471261|NCT00819039|P3|Participant Flow|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471262|NCT00819039|P2|Participant Flow|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471263|NCT00819039|P1|Participant Flow|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471264|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471265|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
471266|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471267|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
471268|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471269|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
471270|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471271|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
471272|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471273|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
471274|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471275|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471276|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471277|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471278|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471279|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471280|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471281|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471282|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471283|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471284|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471285|NCT00819039|E3|Reported Event|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471286|NCT00819039|E2|Reported Event|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471287|NCT00819039|E1|Reported Event|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
471288|NCT00819013|B5|Baseline|Total|Total of all reporting groups
471289|NCT00819013|B4|Baseline|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471290|NCT00819013|B3|Baseline|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471291|NCT00819013|B2|Baseline|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471292|NCT00819013|B1|Baseline|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471293|NCT00819013|P4|Participant Flow|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471294|NCT00819013|P3|Participant Flow|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471295|NCT00819013|P2|Participant Flow|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471296|NCT00819013|P1|Participant Flow|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471297|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471298|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471299|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471300|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471301|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471302|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471303|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471304|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471305|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471306|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471307|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471308|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471309|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471310|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471311|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471312|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471313|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471314|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471315|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471316|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471317|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471318|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471319|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471320|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471321|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471322|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471323|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471324|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471325|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471326|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471327|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471328|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471329|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471330|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471331|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471332|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471333|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471334|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471335|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471336|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471337|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471338|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471339|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471340|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471341|NCT00819013|E4|Reported Event|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
471342|NCT00819013|E3|Reported Event|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
471343|NCT00819013|E2|Reported Event|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
471344|NCT00819013|E1|Reported Event|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
471345|NCT00818961|B1|Baseline|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471346|NCT00818961|P1|Participant Flow|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471347|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471348|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471349|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471350|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471351|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471352|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471353|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471354|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471355|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471356|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471357|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
471358|NCT00818961|E1|Reported Event|Hematopoietic Stem Cell Transplantation|All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
471359|NCT00818883|B3|Baseline|Total|Total of all reporting groups
471360|NCT00818883|B2|Baseline|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471361|NCT00818883|B1|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471362|NCT00818883|P2|Participant Flow|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471363|NCT00818883|P1|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471364|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471365|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471366|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471367|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471368|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471369|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471370|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471371|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471372|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471373|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471374|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471375|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471376|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471377|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471378|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471379|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471380|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471381|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471382|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471414|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
471415|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
471416|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
471383|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471384|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471385|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471386|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471387|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471388|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471389|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471390|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471391|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471392|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471393|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471394|NCT00818883|E2|Reported Event|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
471395|NCT00818883|E1|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
471396|NCT00818805|B1|Baseline|Entire Study Population|
471397|NCT00818805|P2|Participant Flow|Tranilast 0.5% First, Then Olopatadine Second|Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.
471398|NCT00818805|P1|Participant Flow|Olopatadine 0.1% First, Then Tranilast Second|Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next
471399|NCT00818805|O4|Outcome|Placebo (Tranilast)|Placebo (Tranilast) in one eye in either the first or second period
471400|NCT00818805|O3|Outcome|Placebo (Olopatadine)|Placebo (Olopatadine) in one eye in either the first or second period
471401|NCT00818805|O2|Outcome|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
471402|NCT00818805|O1|Outcome|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
471403|NCT00818805|E4|Reported Event|Placebo (Tranilast) One Eye|Placebo (Tranilast) in one eye in either the first or second period
471404|NCT00818805|E3|Reported Event|Placebo (Olopatadine) One Eye|Placebo (Olopatadine) in one eye in either the first or second period
471405|NCT00818805|E2|Reported Event|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
471406|NCT00818805|E1|Reported Event|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
471407|NCT00818779|B3|Baseline|Total|Total of all reporting groups
471408|NCT00818779|B2|Baseline|Amlodipine|5-10 mg amlodipine once daily
471409|NCT00818779|B1|Baseline|Aliskiren|Aliskiren 150-300 mg once daily
471410|NCT00818779|P2|Participant Flow|Amlodipine|5-10 mg amlodipine once daily
471411|NCT00818779|P1|Participant Flow|Aliskiren|Aliskiren 150-300 mg once daily
471422|NCT00818779|E2|Reported Event|Amlodipine|5-10 mg amlodipine once daily
471423|NCT00818779|E1|Reported Event|Aliskiren|Aliskiren 150-300 mg once daily
471424|NCT00818766|B3|Baseline|Total|Total of all reporting groups
471425|NCT00818766|B2|Baseline|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471426|NCT00818766|B1|Baseline|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471427|NCT00818766|P2|Participant Flow|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471428|NCT00818766|P1|Participant Flow|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471429|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471430|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471431|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471432|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471433|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471434|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471435|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471436|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471437|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471438|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471439|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471440|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471441|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471442|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471443|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471444|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471445|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471489|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471648|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471446|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471447|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471448|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471449|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471450|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471451|NCT00818766|E2|Reported Event|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
471452|NCT00818766|E1|Reported Event|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
471453|NCT00818753|B4|Baseline|Total|Total of all reporting groups
471454|NCT00818753|B3|Baseline|Heparin|Unfractionated heparin administered during intervention
471455|NCT00818753|B2|Baseline|Dabigatran 150mg Bis in Die (BID)|
471456|NCT00818753|B1|Baseline|Dabigatran 110mg Bis in Die (BID)|
471457|NCT00818753|P3|Participant Flow|Heparin|Unfractionated heparin administered during intervention
471458|NCT00818753|P2|Participant Flow|Dabigatran 150mg Bis in Die (BID)|
471459|NCT00818753|P1|Participant Flow|Dabigatran 110mg Bis in Die (BID)|
471460|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
471461|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
471462|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
471463|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
471464|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
471465|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
471466|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
471467|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
471468|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
471469|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
471470|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
471471|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
471472|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
471473|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
471474|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
471475|NCT00818753|E3|Reported Event|Heparin|Unfractionated heparin administered during intervention
471476|NCT00818753|E2|Reported Event|Dabigatran 150mg Bis in Die (BID)|
471477|NCT00818753|E1|Reported Event|Dabigatran 110mg Bis in Die (BID)|
471478|NCT00818662|B5|Baseline|Total|Total of all reporting groups
471479|NCT00818662|B4|Baseline|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks~Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
471480|NCT00818662|B3|Baseline|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks~Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
471481|NCT00818662|B2|Baseline|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471482|NCT00818662|B1|Baseline|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471483|NCT00818662|P4|Participant Flow|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks~Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
471484|NCT00818662|P3|Participant Flow|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks~Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
471485|NCT00818662|P2|Participant Flow|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471486|NCT00818662|P1|Participant Flow|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471487|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471488|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471517|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471490|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471491|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471492|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471493|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471494|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471495|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471496|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471497|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471498|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471499|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471500|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471501|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471502|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471503|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471504|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471505|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471506|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471507|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471508|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471509|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471510|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471511|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471512|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471513|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471514|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471515|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471516|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471643|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471644|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471518|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471519|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471520|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471521|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471522|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471523|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471524|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471525|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471526|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471527|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471528|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471529|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471530|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471531|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471532|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471533|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471534|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471535|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471536|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471537|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471538|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471539|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471540|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471541|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471542|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471543|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471544|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471545|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471546|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471547|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471548|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471549|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471550|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
472103|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
471551|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471552|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471553|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471554|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471555|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471556|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471557|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471558|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471559|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471560|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471561|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471562|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
471563|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
471564|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
471565|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471566|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471567|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471568|NCT00818662|E3|Reported Event|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471569|NCT00818662|E2|Reported Event|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471570|NCT00818662|E1|Reported Event|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
471571|NCT00818649|B1|Baseline|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
471572|NCT00818649|P1|Participant Flow|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
471573|NCT00818649|O1|Outcome|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
471574|NCT00818649|O1|Outcome|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
471575|NCT00818649|O1|Outcome|Evaluable Patients|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment continued for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
471645|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471646|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471647|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471576|NCT00818649|E1|Reported Event|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
471577|NCT00818623|B9|Baseline|Total|Total of all reporting groups
471578|NCT00818623|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471579|NCT00818623|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471580|NCT00818623|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471581|NCT00818623|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471582|NCT00818623|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471583|NCT00818623|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471584|NCT00818623|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471585|NCT00818623|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471586|NCT00818623|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471587|NCT00818623|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471588|NCT00818623|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471589|NCT00818623|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471590|NCT00818623|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471591|NCT00818623|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471592|NCT00818623|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471593|NCT00818623|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471594|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471595|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471596|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471597|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471598|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471599|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471600|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471601|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471602|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471603|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471604|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471605|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471606|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471607|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471608|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471609|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471610|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471611|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471612|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471613|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471614|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471615|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471616|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471617|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471618|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471619|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471620|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471621|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471622|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471623|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471624|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471625|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471626|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471627|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471628|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471629|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471630|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471631|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471632|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471633|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471634|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471635|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471636|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471637|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471638|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471639|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471640|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471641|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471642|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471649|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471650|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471651|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471652|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471653|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471654|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471655|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471656|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471657|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471658|NCT00818623|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
471659|NCT00818623|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
471660|NCT00818623|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
471661|NCT00818623|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
471662|NCT00818623|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
471663|NCT00818623|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
471664|NCT00818623|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
471665|NCT00818623|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
471666|NCT00818519|B3|Baseline|Total|Total of all reporting groups
471667|NCT00818519|B2|Baseline|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471668|NCT00818519|B1|Baseline|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471669|NCT00818519|P2|Participant Flow|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471670|NCT00818519|P1|Participant Flow|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471671|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471672|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471673|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471674|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471675|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471676|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471677|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471678|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471679|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471680|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471681|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471682|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471683|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471684|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471685|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471686|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471687|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471688|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471689|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471690|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
472104|NCT00816829|O1|Outcome|Placebo|Placebo
471691|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471692|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471693|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471694|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471695|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471696|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471697|NCT00818519|E2|Reported Event|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
471698|NCT00818519|E1|Reported Event|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
471699|NCT00818454|B1|Baseline|Entire Study Population|Participants randomized to crossover part at randomization 1
471700|NCT00818454|P4|Participant Flow|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
471701|NCT00818454|P3|Participant Flow|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
471702|NCT00818454|P2|Participant Flow|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
471703|NCT00818454|P1|Participant Flow|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
471704|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
471705|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
471706|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
471707|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
471708|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471709|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471710|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471711|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471712|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471713|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471714|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471715|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471716|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471717|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471718|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471719|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471720|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471721|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471722|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
471723|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
471724|NCT00818454|E4|Reported Event|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
471725|NCT00818454|E3|Reported Event|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
471726|NCT00818454|E2|Reported Event|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
471727|NCT00818454|E1|Reported Event|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
471728|NCT00818441|B3|Baseline|Total|Total of all reporting groups
471729|NCT00818441|B2|Baseline|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471730|NCT00818441|B1|Baseline|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471794|NCT00818259|P5|Participant Flow|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
472105|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
472106|NCT00816829|O1|Outcome|Placebo|Placebo
471731|NCT00818441|P2|Participant Flow|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471732|NCT00818441|P1|Participant Flow|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471733|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471734|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471735|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471736|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471737|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471738|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471944|NCT00817778|O1|Outcome|Experimental|AZD1656
471945|NCT00817778|O1|Outcome|Experimental|AZD1656
471739|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471740|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471741|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471742|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471743|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471744|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471745|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471746|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471946|NCT00817778|O1|Outcome|Experimental|AZD1656
471947|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471747|NCT00818441|O1|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471748|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471749|NCT00818441|E2|Reported Event|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
471750|NCT00818441|E1|Reported Event|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
471751|NCT00818389|B3|Baseline|Total|Total of all reporting groups
471752|NCT00818389|B2|Baseline|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
471753|NCT00818389|B1|Baseline|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
471754|NCT00818389|P2|Participant Flow|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
471755|NCT00818389|P1|Participant Flow|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
471756|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
471757|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
471948|NCT00817778|O1|Outcome|Experimental|AZD1656
471949|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471758|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
471759|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
471760|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
471761|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
471762|NCT00818389|E2|Reported Event|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
471763|NCT00818389|E1|Reported Event|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
471764|NCT00818337|B1|Baseline|Aspirin 81mg|Aspirin 81mg at baseline
471765|NCT00818337|P1|Participant Flow|Aspirin 81mg|Aspirin 81mg at baseline
471766|NCT00818337|O1|Outcome|Aspirin 325 mg|Participants who were aspirin resistant who were increased to aspirin 325 mg
471767|NCT00818337|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg at baseline
471768|NCT00818337|E1|Reported Event|Aspirin 81mg|Aspirin 81mg at baseline
471769|NCT00818324|B1|Baseline|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
471770|NCT00818324|P1|Participant Flow|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
471771|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
471772|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
471773|NCT00818324|E1|Reported Event|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
471774|NCT00818272|B1|Baseline|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471775|NCT00818272|P1|Participant Flow|Infliximab|Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471776|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471777|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471950|NCT00817778|O1|Outcome|Experimental|AZD1656
471778|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471779|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471780|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471781|NCT00818272|E1|Reported Event|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
471782|NCT00818259|B8|Baseline|Total|Total of all reporting groups
471783|NCT00818259|B7|Baseline|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471784|NCT00818259|B6|Baseline|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471785|NCT00818259|B5|Baseline|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471786|NCT00818259|B4|Baseline|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471787|NCT00818259|B3|Baseline|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471788|NCT00818259|B2|Baseline|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471789|NCT00818259|B1|Baseline|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471790|NCT00818259|P9|Participant Flow|Part V-Additional Enrollers|Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471791|NCT00818259|P8|Participant Flow|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471792|NCT00818259|P7|Participant Flow|Part IV-Additional Enrollers|Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471793|NCT00818259|P6|Participant Flow|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471951|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471952|NCT00817778|O1|Outcome|Experimental|AZD1656
471953|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471795|NCT00818259|P4|Participant Flow|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471796|NCT00818259|P3|Participant Flow|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471797|NCT00818259|P2|Participant Flow|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471798|NCT00818259|P1|Participant Flow|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471799|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471800|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471801|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471802|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471803|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471804|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471805|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471806|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471807|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471808|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471809|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471810|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471811|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471812|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471813|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471954|NCT00817778|O1|Outcome|Experimental|AZD1656
471955|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471814|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471815|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471816|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471817|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471818|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471819|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471820|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471821|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471822|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471823|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471824|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471825|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471826|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471827|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471828|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471829|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471830|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471831|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471956|NCT00817778|O1|Outcome|Experimental|AZD1656
471957|NCT00817778|E2|Reported Event|Placebo Comparator|Placebo
471832|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471833|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471834|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471835|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471836|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471837|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471838|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471839|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471840|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471841|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471842|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471843|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471844|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471845|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471846|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471847|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471848|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471849|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471850|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471958|NCT00817778|E1|Reported Event|Experimental|AZD1656
471851|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471852|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471853|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471854|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471855|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471856|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471857|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471858|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471859|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471860|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471861|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471862|NCT00818259|E7|Reported Event|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471863|NCT00818259|E6|Reported Event|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
471864|NCT00818259|E5|Reported Event|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
471865|NCT00818259|E4|Reported Event|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471866|NCT00818259|E3|Reported Event|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471867|NCT00818259|E2|Reported Event|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471868|NCT00818259|E1|Reported Event|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
471869|NCT00818246|B1|Baseline|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
472107|NCT00816829|E2|Reported Event|Fenofibrate|Fenofibrate 145 mg
471870|NCT00818246|P1|Participant Flow|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
471871|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
471872|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
471873|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
471874|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
471875|NCT00818246|E1|Reported Event|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
471876|NCT00818207|B3|Baseline|Total|Total of all reporting groups
471877|NCT00818207|B2|Baseline|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471878|NCT00818207|B1|Baseline|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471879|NCT00818207|P2|Participant Flow|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471880|NCT00818207|P1|Participant Flow|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471881|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471882|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471883|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471884|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471885|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471886|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471887|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471888|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471889|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471890|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471891|NCT00818207|E2|Reported Event|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
471959|NCT00817596|B1|Baseline|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
471892|NCT00818207|E1|Reported Event|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
471893|NCT00818168|B1|Baseline|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471894|NCT00818168|P1|Participant Flow|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471895|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471896|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471897|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471898|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471899|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471900|NCT00818168|E1|Reported Event|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
471901|NCT00818116|B1|Baseline|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
471902|NCT00818116|P1|Participant Flow|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
471903|NCT00818116|O1|Outcome|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
471904|NCT00818116|E1|Reported Event|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
471905|NCT00817999|B3|Baseline|Total|Total of all reporting groups
471906|NCT00817999|B2|Baseline|Maintenance Dose|
471907|NCT00817999|B1|Baseline|Loading Dose|
471908|NCT00817999|P2|Participant Flow|Maintenance Dose|Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice.
471909|NCT00817999|P1|Participant Flow|Loading Dose|Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice.
471910|NCT00817999|O4|Outcome|Maintenance Dose Without Grapefruit Juice|
471911|NCT00817999|O3|Outcome|Loading Dose Without Grapefruit Juice|
471912|NCT00817999|O2|Outcome|Maintenance Dose With Grapefruit Juice|
471913|NCT00817999|O1|Outcome|Loading Dose With Grapefruit Juice|
471914|NCT00817999|E2|Reported Event|Maintenance Dose|
471915|NCT00817999|E1|Reported Event|Loading Dose|
471916|NCT00817843|B1|Baseline|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
471917|NCT00817843|P2|Participant Flow|Simvastatin/Ezetimibe 10/10mg First, Then Simvastatin 80mg|First 6 weeks of treatment with simvastatin/ezetimibe 10/10 mg combination with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin 80 mg and placebo
471918|NCT00817843|P1|Participant Flow|Simvastatin 80mg First, Then Simvastatin/Ezetimibe 10/10mg|First 6 weeks of treatment with simvastatin 80 mg with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin/ezetimibe 10/10 mg combination and placebo
471919|NCT00817843|O2|Outcome|Simvastatin 10 mg / Ezetimibe 10 mg|6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg
471920|NCT00817843|O1|Outcome|Simvastatin 80 mg|6 weeks of treatment with simvastatin 80 mg
471921|NCT00817843|E1|Reported Event|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
471922|NCT00817804|B3|Baseline|Total|Total of all reporting groups
471923|NCT00817804|B2|Baseline|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
471924|NCT00817804|B1|Baseline|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
471925|NCT00817804|P2|Participant Flow|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
471926|NCT00817804|P1|Participant Flow|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
471927|NCT00817804|O2|Outcome|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
471928|NCT00817804|O1|Outcome|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
471929|NCT00817804|E2|Reported Event|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
471930|NCT00817804|E1|Reported Event|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
471931|NCT00817778|B3|Baseline|Total|Total of all reporting groups
471932|NCT00817778|B2|Baseline|Placebo Comparator|Placebo
471933|NCT00817778|B1|Baseline|Experimental|AZD1656
471934|NCT00817778|P2|Participant Flow|Placebo Comparator|Placebo
471935|NCT00817778|P1|Participant Flow|Experimental|AZD1656
471936|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471937|NCT00817778|O1|Outcome|Experimental|AZD1656
471938|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471939|NCT00817778|O1|Outcome|Experimental|AZD1656
471940|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
471941|NCT00817778|O1|Outcome|Experimental|AZD1656
471942|NCT00817778|O1|Outcome|Experimental|AZD1656
471943|NCT00817778|O1|Outcome|Experimental|AZD1656
471960|NCT00817596|P1|Participant Flow|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
471961|NCT00817596|O1|Outcome|Group 1|Prometra Intrathecal Pump System
471962|NCT00817596|E1|Reported Event|Group 1|Prometra Intrathecal Pump System
471963|NCT00817531|B1|Baseline|Dasatinib|Patients took Dasatinib 100mg daily
471964|NCT00817531|P1|Participant Flow|Dasatinib|Patients took Dasatinib 100mg daily
471965|NCT00817531|O1|Outcome|Dasatinib|Dasatinib 100 mg once daily
471966|NCT00817531|E1|Reported Event|Dasatinib|Patients took Dasatinib 100mg daily
471967|NCT00817479|B3|Baseline|Total|Total of all reporting groups
471968|NCT00817479|B2|Baseline|Dexamethasone|20 mg dexamethasone IV push
471969|NCT00817479|B1|Baseline|Placebo|Placebo [saline]
471970|NCT00817479|P2|Participant Flow|Dexamethasone|20 mg dexamethasone IV push
471971|NCT00817479|P1|Participant Flow|Placebo|Placebo [saline]
471972|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
471973|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
471974|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
471975|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
471976|NCT00817479|E2|Reported Event|Dexamethasone|20 mg dexamethasone IV push
471977|NCT00817479|E1|Reported Event|Placebo|Placebo [saline]
471978|NCT00817336|B3|Baseline|Total|Total of all reporting groups
471979|NCT00817336|B2|Baseline|Placebo Followed by D-serine|Does not include 1 drop-out during phase 1
471980|NCT00817336|B1|Baseline|D-serine Followed by Placebo|Does not include 1 drop-out during phase 1
471981|NCT00817336|P2|Participant Flow|Placebo Followed by D-serine|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
471982|NCT00817336|P1|Participant Flow|D-serine Followed by Placebo|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
471983|NCT00817336|O2|Outcome|Placebo|Placebo: oral
471984|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day~D Serine: 60 mg/kg/day"
471985|NCT00817336|O2|Outcome|Placebo|Placebo: oral
471986|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day~D Serine: 60 mg/kg/day"
471987|NCT00817336|O2|Outcome|Placebo|Placebo: oral
471988|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day~D Serine: 60 mg/kg/day"
471989|NCT00817336|O2|Outcome|Placebo|Placebo: oral
471990|NCT00817336|O1|Outcome|D-serine|"60 mg/kg/day~D Serine: 60 mg/kg/day"
471991|NCT00817336|E1|Reported Event|D-serine/Placebo Crossover|subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
471992|NCT00817219|B1|Baseline|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
471993|NCT00817219|P1|Participant Flow|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
471994|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
471995|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
471996|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
471997|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
471998|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
471999|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
472000|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
472001|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
472002|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
472003|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
472004|NCT00817219|E1|Reported Event|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
472005|NCT00817206|B3|Baseline|Total|Total of all reporting groups
472006|NCT00817206|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
472007|NCT00817206|B1|Baseline|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
472090|NCT00816829|O1|Outcome|Placebo|Placebo
472008|NCT00817206|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
472009|NCT00817206|P1|Participant Flow|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
472010|NCT00817206|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
472011|NCT00817206|O1|Outcome|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
472012|NCT00817206|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
472013|NCT00817206|E1|Reported Event|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
472014|NCT00817063|B3|Baseline|Total|Total of all reporting groups
472015|NCT00817063|B2|Baseline|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472016|NCT00817063|B1|Baseline|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472017|NCT00817063|P2|Participant Flow|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472018|NCT00817063|P1|Participant Flow|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 milligrams (mg) of alitretinoin oral soft capsule once daily up to 24 weeks.
472019|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472020|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472021|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472022|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472023|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472024|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472025|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472026|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472027|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472028|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472029|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472030|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472031|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472032|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472033|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472034|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472035|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472036|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472091|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
472092|NCT00816829|O1|Outcome|Placebo|Placebo
472037|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472038|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472039|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472040|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472041|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472042|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472043|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472044|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472045|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472046|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472047|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472048|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472049|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472050|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472051|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472052|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472053|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472054|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472055|NCT00817063|O2|Outcome|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472056|NCT00817063|O1|Outcome|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472057|NCT00817063|E2|Reported Event|Placebo|Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks.
472058|NCT00817063|E1|Reported Event|Alitretinoin 30 mg|Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.
472059|NCT00816907|B3|Baseline|Total|Total of all reporting groups
472060|NCT00816907|B2|Baseline|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
472061|NCT00816907|B1|Baseline|Placebo|Matching over-encapsulated placebo pills
472062|NCT00816907|P2|Participant Flow|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
472063|NCT00816907|P1|Participant Flow|Placebo|Matching over-encapsulated placebo pills
472064|NCT00816907|O2|Outcome|Metformin|
472065|NCT00816907|O1|Outcome|Placebo|
472066|NCT00816907|O2|Outcome|Metformin|
472067|NCT00816907|O1|Outcome|Placebo|
472068|NCT00816907|O2|Outcome|Metformin|
472069|NCT00816907|O1|Outcome|Placebo|
472070|NCT00816907|O2|Outcome|Metformin|
472071|NCT00816907|O1|Outcome|Placebo|
472072|NCT00816907|O2|Outcome|Metformin|
472073|NCT00816907|O1|Outcome|Placebo|
472074|NCT00816907|O2|Outcome|Metformin|
472075|NCT00816907|O1|Outcome|Placebo|
472076|NCT00816907|O2|Outcome|Metformin|
472077|NCT00816907|O1|Outcome|Placebo|
472078|NCT00816907|O2|Outcome|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
472079|NCT00816907|O1|Outcome|Placebo|Matching over-encapsulated placebo pills
472080|NCT00816907|E2|Reported Event|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
472081|NCT00816907|E1|Reported Event|Placebo|Matching over-encapsulated placebo pills
472082|NCT00816829|B3|Baseline|Total|Total of all reporting groups
472083|NCT00816829|B2|Baseline|Fenofibrate|Fenofibrate 145 mg
472084|NCT00816829|B1|Baseline|Placebo|Placebo
472085|NCT00816829|P2|Participant Flow|Fenofibrate|Fenofibrate 145 mg
472086|NCT00816829|P1|Participant Flow|Placebo|Placebo
472087|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
472088|NCT00816829|O1|Outcome|Placebo|Placebo
472089|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
472108|NCT00816829|E1|Reported Event|Placebo|Placebo
472109|NCT00816777|B3|Baseline|Total|Total of all reporting groups
472110|NCT00816777|B2|Baseline|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472111|NCT00816777|B1|Baseline|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472112|NCT00816777|P2|Participant Flow|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472113|NCT00816777|P1|Participant Flow|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472114|NCT00816777|O2|Outcome|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472115|NCT00816777|O1|Outcome|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472116|NCT00816777|E2|Reported Event|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472117|NCT00816777|E1|Reported Event|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
472118|NCT00816595|B3|Baseline|Total|Total of all reporting groups
472119|NCT00816595|B2|Baseline|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
472120|NCT00816595|B1|Baseline|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
472121|NCT00816595|P2|Participant Flow|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
472122|NCT00816595|P1|Participant Flow|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
472123|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
472124|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
472125|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
472153|NCT00816400|B7|Baseline|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472441|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
472126|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
472127|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
472128|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
472129|NCT00816595|E2|Reported Event|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
472130|NCT00816595|E1|Reported Event|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
472131|NCT00816556|B4|Baseline|Total|Total of all reporting groups
472132|NCT00816556|B3|Baseline|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472133|NCT00816556|B2|Baseline|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472134|NCT00816556|B1|Baseline|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472135|NCT00816556|P3|Participant Flow|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472136|NCT00816556|P2|Participant Flow|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472137|NCT00816556|P1|Participant Flow|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472138|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472139|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472140|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472141|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472142|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472143|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472144|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472145|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472146|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472147|NCT00816556|E3|Reported Event|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472148|NCT00816556|E2|Reported Event|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472149|NCT00816556|E1|Reported Event|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
472150|NCT00816400|B10|Baseline|Total|Total of all reporting groups
472151|NCT00816400|B9|Baseline|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472152|NCT00816400|B8|Baseline|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
473262|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
472154|NCT00816400|B6|Baseline|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472155|NCT00816400|B5|Baseline|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472156|NCT00816400|B4|Baseline|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472157|NCT00816400|B3|Baseline|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472158|NCT00816400|B2|Baseline|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472159|NCT00816400|B1|Baseline|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472160|NCT00816400|P9|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472161|NCT00816400|P8|Participant Flow|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472162|NCT00816400|P7|Participant Flow|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472163|NCT00816400|P6|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472164|NCT00816400|P5|Participant Flow|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472165|NCT00816400|P4|Participant Flow|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472166|NCT00816400|P3|Participant Flow|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472167|NCT00816400|P2|Participant Flow|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472168|NCT00816400|P1|Participant Flow|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472169|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472170|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472171|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472172|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472173|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472174|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472442|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
472175|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472176|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472177|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472178|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472179|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472180|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472181|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472182|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472183|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472184|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472185|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472186|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472187|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472188|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472189|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472190|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472191|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472192|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472193|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472194|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472195|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472500|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472196|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472197|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472198|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472199|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472200|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472201|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472202|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472203|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472204|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472205|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472206|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472207|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472208|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472209|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472210|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472211|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472212|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472213|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472214|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472215|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472216|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472283|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472217|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472218|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472219|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472220|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472221|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472222|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472223|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472224|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472225|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472226|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472227|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472228|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472229|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472230|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472231|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472232|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472233|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472234|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
472235|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472236|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472237|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472238|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472239|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472240|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472241|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472242|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472243|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472244|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
472245|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472246|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472247|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472248|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472249|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472250|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472251|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472252|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472253|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472254|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
472255|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472256|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472257|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472258|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472259|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472260|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472501|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472261|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472262|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472263|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472264|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
472265|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472266|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472267|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472268|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472269|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472270|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472271|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472272|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472273|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472274|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
472275|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472276|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472277|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472278|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472279|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472280|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472281|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472282|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472284|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
472285|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472286|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472287|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472288|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472289|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472290|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472291|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472292|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472293|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472294|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472295|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472296|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472297|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472298|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472299|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472300|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472301|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472302|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472303|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472304|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472305|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472306|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472307|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472308|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472309|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472310|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472311|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472312|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472313|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472314|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472315|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472316|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472317|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472318|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472319|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472320|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472321|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472322|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472323|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472324|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472325|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472326|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472502|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472327|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472328|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472329|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472330|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472331|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472332|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472333|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472334|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472335|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472336|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472337|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472338|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472339|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472340|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472341|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472342|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472343|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472344|NCT00816400|E7|Reported Event|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472345|NCT00816400|E6|Reported Event|MEDI-575, 25 mg/kg Q3Wk Escalation/Expansion Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472346|NCT00816400|E5|Reported Event|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472347|NCT00816400|E4|Reported Event|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472437|NCT00815776|O3|Outcome|Jaw Exercise Group|This subject group received no device but was assigned to complete a study-specified jaw exercise program
472348|NCT00816400|E3|Reported Event|MEDI-575, 9.0 mg/kg QWk Escalation/Expansion Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21 day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472349|NCT00816400|E2|Reported Event|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472350|NCT00816400|E1|Reported Event|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
472351|NCT00816348|B1|Baseline|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
472352|NCT00816348|P1|Participant Flow|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
472353|NCT00816348|O1|Outcome|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
472354|NCT00816348|E1|Reported Event|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
472355|NCT00816166|B3|Baseline|Total|Total of all reporting groups
472356|NCT00816166|B2|Baseline|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
472357|NCT00816166|B1|Baseline|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
472358|NCT00816166|P2|Participant Flow|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
472359|NCT00816166|P1|Participant Flow|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
472360|NCT00816166|O2|Outcome|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
472361|NCT00816166|O1|Outcome|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
472362|NCT00816166|E2|Reported Event|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
472363|NCT00816166|E1|Reported Event|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
472364|NCT00816101|B4|Baseline|Total|Total of all reporting groups
472365|NCT00816101|B3|Baseline|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
472366|NCT00816101|B2|Baseline|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
472367|NCT00816101|B1|Baseline|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
472438|NCT00815776|O2|Outcome|Mouth Splint Group|This group was not part of the analysis
472368|NCT00816101|P3|Participant Flow|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
472369|NCT00816101|P2|Participant Flow|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
472370|NCT00816101|P1|Participant Flow|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
472371|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
472372|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
472373|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
472374|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
472375|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
472376|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
472377|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
472378|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
472379|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
472380|NCT00816101|E3|Reported Event|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
472381|NCT00816101|E2|Reported Event|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
472382|NCT00816101|E1|Reported Event|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
472383|NCT00816062|B1|Baseline|Treatment|"Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU. >~> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement."
472384|NCT00816062|P1|Participant Flow|Talent Abdominal Stent Graft|"Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the Food and Drug Administration (FDA) approved Instructions for Use (IFU).~>~> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement."
472385|NCT00816062|O1|Outcome|Treatment|"Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU. >~> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement."
472386|NCT00816062|E2|Reported Event|2. ELPS|Medtronic ELPS
472387|NCT00816062|E1|Reported Event|1. Vitality|Medtronic Vitality
472388|NCT00816036|B3|Baseline|Total|Total of all reporting groups
472389|NCT00816036|B2|Baseline|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
472390|NCT00816036|B1|Baseline|Arm 1|Pre-intervention Period
472391|NCT00816036|P2|Participant Flow|Intervention Period|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
472392|NCT00816036|P1|Participant Flow|Pre-intervention Period|Pre-intervention Period
472393|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
472394|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
472439|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|This group of subjects received the Clayton Intra-aural Device
472440|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
472395|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
472396|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
472397|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
472398|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
472399|NCT00816036|E2|Reported Event|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
472400|NCT00816036|E1|Reported Event|Arm 1|Pre-intervention Period
472401|NCT00816023|B5|Baseline|Total|Total of all reporting groups
472402|NCT00816023|B4|Baseline|Placebo|
472403|NCT00816023|B3|Baseline|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
472404|NCT00816023|B2|Baseline|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
472405|NCT00816023|B1|Baseline|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
472406|NCT00816023|P4|Participant Flow|Placebo|
472407|NCT00816023|P3|Participant Flow|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
472408|NCT00816023|P2|Participant Flow|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
472409|NCT00816023|P1|Participant Flow|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
472410|NCT00816023|O4|Outcome|Placebo|
472411|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
472412|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
472413|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
472414|NCT00816023|O4|Outcome|Placebo|
472415|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
472416|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
472417|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
472418|NCT00816023|E4|Reported Event|PLACEBO|
472419|NCT00816023|E3|Reported Event|ECALLANTIDE LOW DOSE|Target steady state concentration of 0.15 mg/L
472420|NCT00816023|E2|Reported Event|ECALLANTIDE MEDIUM DOSE|Target steady state concentration of 0.75 mg/L
472421|NCT00816023|E1|Reported Event|ECALLANTIDE HIGH DOSE|Target steady state concentration of 2.25 mg/L
472422|NCT00815919|B1|Baseline|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472423|NCT00815919|P1|Participant Flow|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472424|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472425|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472426|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472427|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472428|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472429|NCT00815919|E1|Reported Event|Velcade (Bortezomib)|"Prednisone : Taken orally once a day. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~bortezomib : Given intravenously once a week for the first four weeks of a five week cycle for a total of 3 cycles"
472430|NCT00815776|B4|Baseline|Total|Total of all reporting groups
472431|NCT00815776|B3|Baseline|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
472432|NCT00815776|B2|Baseline|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
472433|NCT00815776|B1|Baseline|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
472434|NCT00815776|P3|Participant Flow|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
472435|NCT00815776|P2|Participant Flow|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
472436|NCT00815776|P1|Participant Flow|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
472443|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
472444|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
472445|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
472446|NCT00815776|E3|Reported Event|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
472447|NCT00815776|E2|Reported Event|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
472448|NCT00815776|E1|Reported Event|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
472449|NCT00815698|B3|Baseline|Total|Total of all reporting groups
472450|NCT00815698|B2|Baseline|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
472451|NCT00815698|B1|Baseline|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
472452|NCT00815698|P2|Participant Flow|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
472453|NCT00815698|P1|Participant Flow|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
472454|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
472455|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
472456|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
472457|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
472458|NCT00815698|E2|Reported Event|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
472459|NCT00815698|E1|Reported Event|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
472460|NCT00815685|B1|Baseline|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
472461|NCT00815685|P1|Participant Flow|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
472462|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
472463|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
472464|NCT00815685|E1|Reported Event|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
472465|NCT00815659|B1|Baseline|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472466|NCT00815659|P1|Participant Flow|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472467|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472468|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472469|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472470|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472471|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472472|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472473|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472474|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472475|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472476|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472477|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472478|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472479|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472480|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472481|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472482|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472483|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472484|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472485|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472486|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472487|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472488|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472489|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472490|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472491|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472492|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472493|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472494|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472495|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472496|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472497|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472498|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472499|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472503|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472504|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472505|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472506|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472507|NCT00815659|E1|Reported Event|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
472508|NCT00815633|B1|Baseline|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
472509|NCT00815633|P1|Participant Flow|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
472510|NCT00815633|O1|Outcome|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
472511|NCT00815633|O1|Outcome|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
472512|NCT00815633|E1|Reported Event|Alefacept|"Treatment Group (only one group)~Alefacept: 15mg intramuscular injection weekly for 12 weeks"
472513|NCT00815516|B3|Baseline|Total|Total of all reporting groups
472514|NCT00815516|B2|Baseline|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472515|NCT00815516|B1|Baseline|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472516|NCT00815516|P2|Participant Flow|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472517|NCT00815516|P1|Participant Flow|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472518|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472519|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472520|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472521|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472522|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472523|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472524|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472525|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472526|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472527|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472528|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472529|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472530|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472531|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472532|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472579|NCT00815347|E2|Reported Event|Placebo|Placebo orally, twice a day for four weeks.
472580|NCT00815347|E1|Reported Event|Bosentan|Bosentan 62.5mg orally, twice a day for four weeks.
472533|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472534|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472535|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472536|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472537|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472538|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472539|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472540|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472541|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472542|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472543|NCT00815516|E2|Reported Event|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472544|NCT00815516|E1|Reported Event|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
472545|NCT00815490|B3|Baseline|Total|Total of all reporting groups
472546|NCT00815490|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
472547|NCT00815490|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
472548|NCT00815490|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
472549|NCT00815490|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
472550|NCT00815490|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
472551|NCT00815490|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
472552|NCT00815490|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
472553|NCT00815490|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
472554|NCT00815360|B3|Baseline|Total|Total of all reporting groups
472555|NCT00815360|B2|Baseline|Comparative Group 1|Intravitreal triamcinolone with macular laser
472556|NCT00815360|B1|Baseline|Treatment Group 1|ranibizumab and scatter laser
472557|NCT00815360|P2|Participant Flow|Comparative Group 1|Intravitreal triamcinolone with macular laser
472558|NCT00815360|P1|Participant Flow|Treatment Group 1|ranibizumab and scatter laser
472559|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
472560|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
472561|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
472562|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
472563|NCT00815360|E2|Reported Event|Comparative Group 1|Intravitreal triamcinolone acetonide and macular laser
472564|NCT00815360|E1|Reported Event|Treatment Group 1|Intravitreal ranibizumab and peripheral laser
472565|NCT00815347|B1|Baseline|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
472566|NCT00815347|P1|Participant Flow|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
472567|NCT00815347|O2|Outcome|Bosentan|
472568|NCT00815347|O1|Outcome|Placebo|
472569|NCT00815347|O2|Outcome|Bosentan|
472570|NCT00815347|O1|Outcome|Placebo|
472571|NCT00815347|O2|Outcome|Bosentan|
472572|NCT00815347|O1|Outcome|Placebo|
472573|NCT00815347|O2|Outcome|Bosentan|
472574|NCT00815347|O1|Outcome|Placebo|
472575|NCT00815347|O2|Outcome|Bosentan|
472576|NCT00815347|O1|Outcome|Placebo|
472577|NCT00815347|O2|Outcome|Bosentan|
472578|NCT00815347|O1|Outcome|Placebo|
472581|NCT00815308|B1|Baseline|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
472582|NCT00815308|P1|Participant Flow|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
472583|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
472584|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
472585|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
472586|NCT00815308|E1|Reported Event|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
472587|NCT00815295|B4|Baseline|Total|Total of all reporting groups
472588|NCT00815295|B3|Baseline|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
472589|NCT00815295|B2|Baseline|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
472590|NCT00815295|B1|Baseline|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
472591|NCT00815295|P3|Participant Flow|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
472592|NCT00815295|P2|Participant Flow|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
472593|NCT00815295|P1|Participant Flow|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
472594|NCT00815295|O1|Outcome|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
472595|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
472596|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
472597|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
472598|NCT00815295|O1|Outcome|Phase 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg or 400 mg was administered orally twice daily. The dose of sorafenib was escalated from 200 mg to 400 mg in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT).
472599|NCT00815295|E3|Reported Event|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
472600|NCT00815295|E2|Reported Event|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg/m2 was administered orally twice daily.
472601|NCT00815295|E1|Reported Event|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg/m2 was administered orally twice daily.
472602|NCT00815191|B3|Baseline|Total|Total of all reporting groups
472603|NCT00815191|B2|Baseline|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
472604|NCT00815191|B1|Baseline|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
473087|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
472605|NCT00815191|P2|Participant Flow|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
472606|NCT00815191|P1|Participant Flow|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
472607|NCT00815191|O2|Outcome|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
472608|NCT00815191|O1|Outcome|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
472609|NCT00815191|E2|Reported Event|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
472610|NCT00815191|E1|Reported Event|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
472611|NCT00815087|B3|Baseline|Total|Total of all reporting groups
472612|NCT00815087|B2|Baseline|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
472613|NCT00815087|B1|Baseline|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
472614|NCT00815087|P2|Participant Flow|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
472615|NCT00815087|P1|Participant Flow|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
472616|NCT00815087|O2|Outcome|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
472617|NCT00815087|O1|Outcome|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
472618|NCT00815087|E2|Reported Event|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
472619|NCT00815087|E1|Reported Event|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
472620|NCT00815035|B3|Baseline|Total|Total of all reporting groups
472621|NCT00815035|B2|Baseline|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
472622|NCT00815035|B1|Baseline|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472623|NCT00815035|P3|Participant Flow|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472624|NCT00815035|P2|Participant Flow|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
472625|NCT00815035|P1|Participant Flow|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472626|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472627|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
472628|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472629|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472630|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
472631|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472632|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472633|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
472902|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472634|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472635|NCT00815035|O1|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472636|NCT00815035|O1|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472637|NCT00815035|E3|Reported Event|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472638|NCT00815035|E2|Reported Event|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
472639|NCT00815035|E1|Reported Event|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
472640|NCT00814983|B3|Baseline|Total|Total of all reporting groups
472641|NCT00814983|B2|Baseline|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
472642|NCT00814983|B1|Baseline|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
472643|NCT00814983|P2|Participant Flow|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
472644|NCT00814983|P1|Participant Flow|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
472645|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
472646|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
472647|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
472648|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
472649|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
472650|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
472651|NCT00814983|E2|Reported Event|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
472652|NCT00814983|E1|Reported Event|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
472653|NCT00814970|B1|Baseline|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472654|NCT00814970|P1|Participant Flow|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472655|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
472656|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
472657|NCT00814970|O1|Outcome|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472680|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472903|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
472658|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
472659|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472660|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472661|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472662|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472663|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472664|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472665|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472666|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472667|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472668|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472669|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472670|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472671|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472672|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
472673|NCT00814970|E1|Reported Event|1. Complete SE Vascular Stent System|Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
472674|NCT00814892|B1|Baseline|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472675|NCT00814892|P1|Participant Flow|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472676|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472677|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472678|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472679|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472899|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
472681|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472682|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472683|NCT00814892|E1|Reported Event|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
472684|NCT00814879|B3|Baseline|Total|Total of all reporting groups
472685|NCT00814879|B2|Baseline|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472686|NCT00814879|B1|Baseline|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472687|NCT00814879|P2|Participant Flow|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472688|NCT00814879|P1|Participant Flow|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472689|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472690|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472691|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472692|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472693|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472694|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472695|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472696|NCT00814879|O1|Outcome|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472697|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472698|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472699|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472700|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472701|NCT00814879|E2|Reported Event|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
472702|NCT00814879|E1|Reported Event|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
472703|NCT00814801|B4|Baseline|Total|Total of all reporting groups
472704|NCT00814801|B3|Baseline|Galantamine Group 2|Galantamine 24 mg/day
472705|NCT00814801|B2|Baseline|Galantamine Group 1|Galantamine 16 mg/day
472706|NCT00814801|B1|Baseline|Placebo Group|
472707|NCT00814801|P3|Participant Flow|Galantamine Group 2|Galantamine 24 mg/day
472708|NCT00814801|P2|Participant Flow|Galantamine Group 1|Galantamine 16 mg/day
472709|NCT00814801|P1|Participant Flow|Placebo Group|
472710|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
472711|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
472712|NCT00814801|O1|Outcome|Placebo Group|
472713|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
472714|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
472715|NCT00814801|O1|Outcome|Placebo Group|
472716|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
472717|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
472718|NCT00814801|O1|Outcome|Placebo Group|
472719|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
472720|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
472721|NCT00814801|O1|Outcome|Placebo Group|
472722|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
472723|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
472724|NCT00814801|O1|Outcome|Placebo Group|
472725|NCT00814801|E3|Reported Event|Galantamine Group 2|Galantamine 24 mg/day
472726|NCT00814801|E2|Reported Event|Galantamine Group 1|Galantamine 16 mg/day
472727|NCT00814801|E1|Reported Event|Placebo Group|
472728|NCT00814788|B1|Baseline|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bicalutamide: Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
472729|NCT00814788|P1|Participant Flow|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
472730|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide: 50 mg oral tablet daily~Everolimus: 10 mg oral capsule daily"
472731|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
472732|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bicalutamide: Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
472733|NCT00814788|E1|Reported Event|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
472734|NCT00814775|B3|Baseline|Total|Total of all reporting groups
472735|NCT00814775|B2|Baseline|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
472736|NCT00814775|B1|Baseline|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
472737|NCT00814775|P2|Participant Flow|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
472738|NCT00814775|P1|Participant Flow|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
472739|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
472740|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
472741|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
472742|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
472743|NCT00814775|E2|Reported Event|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
472744|NCT00814775|E1|Reported Event|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
472745|NCT00814710|B3|Baseline|Total|Total of all reporting groups
472746|NCT00814710|B2|Baseline|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472747|NCT00814710|B1|Baseline|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472748|NCT00814710|P2|Participant Flow|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472749|NCT00814710|P1|Participant Flow|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472750|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472751|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472752|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472753|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472754|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472755|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472756|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472757|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472758|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472759|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472760|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472761|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472900|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472762|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472763|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472764|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472765|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472766|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472767|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472768|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472769|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472770|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472771|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472772|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472773|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472774|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472775|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472776|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472777|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472778|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472779|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472780|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472781|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472782|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472783|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472784|NCT00814710|E2|Reported Event|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472785|NCT00814710|E1|Reported Event|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
472786|NCT00814697|B1|Baseline|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
472787|NCT00814697|P1|Participant Flow|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
472788|NCT00814697|O1|Outcome|Cognitive Assessment|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
472789|NCT00814697|E1|Reported Event|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
472790|NCT00814671|B4|Baseline|Total|Total of all reporting groups
472791|NCT00814671|B3|Baseline|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472792|NCT00814671|B2|Baseline|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472793|NCT00814671|B1|Baseline|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472794|NCT00814671|P3|Participant Flow|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472795|NCT00814671|P2|Participant Flow|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472796|NCT00814671|P1|Participant Flow|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472797|NCT00814671|O2|Outcome|Rifapentine 600 mg|Rifapentine 600 mg
472798|NCT00814671|O1|Outcome|Rifapentine 450 mg|Rifapentine 450 mg
472799|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine 600: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472800|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472801|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine 450: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472802|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine 600: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472803|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472804|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine 450: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472805|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472806|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472807|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472808|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472809|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472810|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472811|NCT00814671|E3|Reported Event|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472812|NCT00814671|E2|Reported Event|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472813|NCT00814671|E1|Reported Event|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
472814|NCT00814658|B3|Baseline|Total|Total of all reporting groups
472815|NCT00814658|B2|Baseline|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472816|NCT00814658|B1|Baseline|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472817|NCT00814658|P2|Participant Flow|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472818|NCT00814658|P1|Participant Flow|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472819|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472820|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472901|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
473263|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
472821|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472822|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472823|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472824|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472825|NCT00814658|O8|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472826|NCT00814658|O7|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472827|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 16)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472828|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 16)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472829|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472830|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472831|NCT00814658|O2|Outcome|Galantamine + Placebo (Week 4)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472832|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Week 4)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472833|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472834|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472835|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472836|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472837|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472838|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472839|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472840|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472841|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472842|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472843|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
473084|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
472844|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472845|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472846|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472847|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472848|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472849|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472850|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472851|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472852|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472853|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472854|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472855|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472856|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472857|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472858|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472859|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472860|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472861|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472862|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472863|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472864|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472865|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472866|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
473182|NCT00814320|O1|Outcome|Study Epoch 1|Epoch 1 - IV administration of IGIV, 10%
472867|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472868|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472869|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472870|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472871|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472872|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472873|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472874|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472875|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472876|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472877|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472878|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472879|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472880|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472881|NCT00814658|E2|Reported Event|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
472882|NCT00814658|E1|Reported Event|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
472883|NCT00814632|B1|Baseline|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
472884|NCT00814632|P1|Participant Flow|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
472885|NCT00814632|O1|Outcome|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
472886|NCT00814632|E1|Reported Event|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
472887|NCT00814580|B3|Baseline|Total|Total of all reporting groups
472888|NCT00814580|B2|Baseline|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472889|NCT00814580|B1|Baseline|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472890|NCT00814580|P2|Participant Flow|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472891|NCT00814580|P1|Participant Flow|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472892|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
472893|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
472894|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472895|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472896|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472897|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
472898|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
472904|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
472905|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
472906|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472907|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472908|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472909|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
472910|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
472911|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
472912|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472913|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472914|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472915|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
472916|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
472917|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
472918|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472919|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472920|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472921|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
472922|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
472923|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
472924|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472925|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472926|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472927|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
472928|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
472929|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
472930|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472931|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472932|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472933|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
472934|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
472935|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
472936|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472937|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472938|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472939|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
472940|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
472941|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
472942|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472943|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472944|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472945|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
472946|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
472947|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
472948|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472949|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472950|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
473085|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
472951|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
472952|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
472953|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
472954|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472955|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472956|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472957|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
472958|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
472959|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
472960|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472961|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472962|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472963|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
472964|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
472965|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
472966|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472967|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472968|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472969|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
472970|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
472971|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
472972|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
472973|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
472974|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
472975|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
472976|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472977|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472978|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472979|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472980|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472981|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472982|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472983|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472984|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472985|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472986|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472987|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472988|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472989|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472990|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472991|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472992|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472993|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472994|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472995|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
472996|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472997|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473260|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
472998|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
472999|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473000|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473001|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473002|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473003|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473004|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473005|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473006|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473007|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473008|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473009|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473010|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473011|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473012|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473013|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473014|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473015|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473016|NCT00814580|E2|Reported Event|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
473017|NCT00814580|E1|Reported Event|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
473018|NCT00814502|B3|Baseline|Total|Total of all reporting groups
473019|NCT00814502|B2|Baseline|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473020|NCT00814502|B1|Baseline|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473021|NCT00814502|P2|Participant Flow|Placebo|"Subjects randomized to Placebo~After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473022|NCT00814502|P1|Participant Flow|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473023|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473024|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473025|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473026|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473027|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo~After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473028|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473029|NCT00814502|E2|Reported Event|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473030|NCT00814502|E1|Reported Event|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
473031|NCT00814489|B4|Baseline|Total|Total of all reporting groups
473261|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
473032|NCT00814489|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473033|NCT00814489|B2|Baseline|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473034|NCT00814489|B1|Baseline|GSK2254233A Group|Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473035|NCT00814489|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473036|NCT00814489|P2|Participant Flow|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473037|NCT00814489|P1|Participant Flow|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473038|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473039|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473040|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473041|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473042|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473043|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473044|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473045|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473046|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473047|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473048|NCT00814489|O2|Outcome|GSK2254232A Non-adjuvanted Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473049|NCT00814489|O1|Outcome|GSK2254232A Adjuvanted Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473050|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473051|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473052|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473053|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473054|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473055|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473056|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473057|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473058|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473059|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473086|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473060|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473061|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473062|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473063|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473064|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473065|NCT00814489|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473066|NCT00814489|E2|Reported Event|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473067|NCT00814489|E1|Reported Event|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
473068|NCT00814463|B1|Baseline|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
473069|NCT00814463|P1|Participant Flow|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
473070|NCT00814463|O1|Outcome|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
473071|NCT00814463|E1|Reported Event|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
473072|NCT00814346|B3|Baseline|Total|Total of all reporting groups
473073|NCT00814346|B2|Baseline|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
473074|NCT00814346|B1|Baseline|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
473075|NCT00814346|P2|Participant Flow|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
473076|NCT00814346|P1|Participant Flow|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
473077|NCT00814346|O2|Outcome|EGb761 120 mg (MC)|EGb761 120 mg 17 months (open phase) for MC patients
473078|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473079|NCT00814346|O3|Outcome|EGb761 120 mg (Open Phase)|EGb761 120 mg twice a day for 17 months (open phase) for MC and CNE patients
473080|NCT00814346|O2|Outcome|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
473081|NCT00814346|O1|Outcome|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
473082|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473083|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473088|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473089|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473090|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473091|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473092|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473093|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473094|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473095|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473096|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473097|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473098|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473099|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473100|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (Open phase) for MC patients
473101|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473102|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473103|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473104|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473105|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473106|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473107|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473108|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473109|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473110|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473111|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473112|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473113|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473114|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473115|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473116|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473117|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473118|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473119|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473120|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473121|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473122|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473123|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473124|NCT00814346|O4|Outcome|Placebo (MC)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
473125|NCT00814346|O3|Outcome|EGb761 120 mg (MC)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
473126|NCT00814346|O2|Outcome|Placebo (CNE)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
473127|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
473128|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473129|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473130|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
473131|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473132|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patient
473133|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473134|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg 17 months (open phase) for MC patients
473135|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
473136|NCT00814346|E3|Reported Event|EGb761 120 mg (Open Phase)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC and CNE patients
473181|NCT00814320|O2|Outcome|Study Epoch 2|Epoch 2 - SC administration of IGIV, 10% with rHuPH20 after ramp-up
473137|NCT00814346|E2|Reported Event|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
473138|NCT00814346|E1|Reported Event|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
473139|NCT00814333|B3|Baseline|Total|Total of all reporting groups
473140|NCT00814333|B2|Baseline|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
473141|NCT00814333|B1|Baseline|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
473142|NCT00814333|P2|Participant Flow|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
473143|NCT00814333|P1|Participant Flow|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
473144|NCT00814333|O2|Outcome|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
473145|NCT00814333|O1|Outcome|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
473146|NCT00814333|E2|Reported Event|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
473147|NCT00814333|E1|Reported Event|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
473148|NCT00814320|B3|Baseline|Total|Total of all reporting groups
473149|NCT00814320|B2|Baseline|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV).~Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603).~EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.~Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
473150|NCT00814320|B1|Baseline|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
473151|NCT00814320|P2|Participant Flow|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%.~Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study.~EPOCH 2 RAMP-UP (ramp-up):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG.~EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.~Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
473152|NCT00814320|P1|Participant Flow|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
473153|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
473154|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
473155|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473156|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473157|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473158|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473159|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473160|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473161|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 With Ramp-up|
473162|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473163|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473164|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473165|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473166|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473167|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473168|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473169|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473170|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473171|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473172|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473173|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473174|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473175|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473176|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473177|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473178|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473179|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473180|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473183|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473184|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473185|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|
473186|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473187|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473188|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473189|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473190|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473191|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473192|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473193|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473194|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473195|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473196|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473197|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473198|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473199|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473200|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20 at Ramp-up|At start of SC administration of IGIV, 10% with rHuPH20, the first SC dose was a 1-week dose given for a 1-week interval, then if the 1 week SC infusions were tolerated, each week the interval (and dose) was increased by 1 week, until the treatment interval was the same as the interval for intravenous treatment (3 weeks or 4 weeks)
473201|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473202|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473203|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10%
473204|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473205|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473206|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473207|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473208|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473209|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473210|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473211|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473212|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473213|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473214|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473215|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473216|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473217|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473218|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473219|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473220|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473221|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
473222|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473223|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473224|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473225|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473226|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473227|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473228|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473229|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473230|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473231|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473232|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473233|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473234|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473235|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473236|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473237|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473238|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473239|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473240|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473241|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473242|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473243|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473244|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473245|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473246|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473247|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473248|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473249|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473250|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473251|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473252|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473253|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473254|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473255|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473256|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473257|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
473258|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473259|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
473264|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
473265|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
473266|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
473267|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
473268|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
473269|NCT00814320|O2|Outcome|Participants ≥12 Years|
473270|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
473271|NCT00814320|O2|Outcome|SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up|
473272|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
473273|NCT00814320|O1|Outcome|Ratio IgG AUC of SC With and Without rHuPH20|Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10%
473274|NCT00814320|O1|Outcome|%Ratio IgG Trough Level of SC/IV|Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to < 12 years
473275|NCT00814320|O1|Outcome|% Ratio IgG AUC/Week of SC/ IV|Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10%
473276|NCT00814320|O1|Outcome|Full Analysis Data Set (FADS)|All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
473277|NCT00814320|E2|Reported Event|SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)|"Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up.~Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC.~During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
473278|NCT00814320|E1|Reported Event|IV Administration of IGIV, 10%|Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.
473279|NCT00814307|B5|Baseline|Total|Total of all reporting groups
473280|NCT00814307|B4|Baseline|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473281|NCT00814307|B3|Baseline|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473282|NCT00814307|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473283|NCT00814307|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473284|NCT00814307|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473285|NCT00814307|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473286|NCT00814307|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473287|NCT00814307|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473288|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473289|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473290|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473291|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473292|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473293|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473294|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473295|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473296|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473297|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473298|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473299|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473300|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473301|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473302|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473303|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473304|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473305|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473306|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473307|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473308|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473309|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473310|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473311|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473312|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473313|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473314|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473315|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473316|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473317|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473318|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473319|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473320|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473321|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473322|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473323|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473324|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473325|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473326|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473327|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473328|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473329|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473330|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473331|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473332|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473333|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473334|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473335|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473336|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473337|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473338|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473339|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473340|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473341|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473342|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473343|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473344|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473345|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473346|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473347|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473348|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473349|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473350|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473351|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473352|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473353|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473354|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473355|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473356|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473357|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473358|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473359|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473360|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473361|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473362|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473363|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473364|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473365|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473366|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473367|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473368|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473369|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473370|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473371|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473372|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473373|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473374|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473375|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473376|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473377|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473378|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473379|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473380|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473381|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473382|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473383|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473384|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473385|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473386|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473387|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473388|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473389|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473390|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473391|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473392|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473393|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473394|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473395|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473396|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473397|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473398|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473399|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473400|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473401|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473402|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473403|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473404|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473405|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473406|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473407|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473408|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473409|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473410|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473411|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473412|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473413|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473414|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473415|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473416|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473417|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473418|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473419|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473420|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473421|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473422|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473423|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473424|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473425|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473426|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473427|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473428|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
473429|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473430|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473431|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473432|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473433|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473434|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473435|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473436|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473437|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473438|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473439|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473440|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
473441|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
473442|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
473443|NCT00814307|E5|Reported Event|CP-690550 10 mg (Post Month 3)|CP-690550 10 mg tablet orally twice daily from Month 3 to Month 6.
473444|NCT00814307|E4|Reported Event|CP-690550 5 mg (Post Month 3)|CP-690550 5 mg tablet orally twice daily from Month 3 to Month 6.
473445|NCT00814307|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo tablet orally twice daily up to Month 3.
473446|NCT00814307|E2|Reported Event|CP-690550 10 mg (Up To Month 3)|CP-690550 10 mg tablet orally twice daily up to Month 3.
473447|NCT00814307|E1|Reported Event|CP-690550 5 mg (Up To Month 3)|CP-690550 5 mg tablet orally twice daily up to Month 3.
473448|NCT00814255|B4|Baseline|Total|Total of all reporting groups
473449|NCT00814255|B3|Baseline|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
473450|NCT00814255|B2|Baseline|Conservative Medical Therapy|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
473451|NCT00814255|B1|Baseline|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
473452|NCT00814255|P3|Participant Flow|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
473453|NCT00814255|P2|Participant Flow|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
473454|NCT00814255|P1|Participant Flow|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
473455|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
473456|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
473457|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
473458|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
473459|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
473460|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
473461|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
473462|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
473463|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
473464|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
473465|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
473466|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
473467|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID 2 out of 7"
473468|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day 2 out of 7"
473469|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days 0 out of 7"
473470|NCT00814255|E3|Reported Event|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
473471|NCT00814255|E2|Reported Event|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
473472|NCT00814255|E1|Reported Event|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
473473|NCT00814177|B3|Baseline|Total|Total of all reporting groups
473474|NCT00814177|B2|Baseline|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
473475|NCT00814177|B1|Baseline|No Change|Intervention Drug warfarin no change in the dose is performed
473476|NCT00814177|P2|Participant Flow|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
473477|NCT00814177|P1|Participant Flow|No Change|Intervention Drug warfarin no change in the dose is performed
473478|NCT00814177|O2|Outcome|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
473479|NCT00814177|O1|Outcome|No Change|Intervention Drug warfarin no change in the dose is performed
473480|NCT00814177|E2|Reported Event|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
473481|NCT00814177|E1|Reported Event|No Change|Intervention Drug warfarin no change in the dose is performed
473482|NCT00814164|B1|Baseline|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473483|NCT00814164|P1|Participant Flow|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473484|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473485|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473929|NCT00813098|P1|Participant Flow|High Dose|A high dose of LX1031; daily oral intake for 28 days
473486|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473487|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473488|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473489|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473490|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473491|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473492|NCT00814164|E1|Reported Event|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
473493|NCT00814138|B3|Baseline|Total|Total of all reporting groups
473494|NCT00814138|B2|Baseline|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473495|NCT00814138|B1|Baseline|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473496|NCT00814138|P2|Participant Flow|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473497|NCT00814138|P1|Participant Flow|1 - Methotrexate (2.5 mg)|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473498|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473499|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473500|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473501|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473502|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473503|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473504|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473505|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473506|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473507|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473508|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
473509|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
473510|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473511|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
473512|NCT00814138|E2|Reported Event|Placebo Group - Adverse Events|Reported the number of adverse events in the group randomized to placebo
473513|NCT00814138|E1|Reported Event|Methotrexate Group - Adverse Events|Reported the number of adverse events in the group randomized to methotrexate.
473514|NCT00813995|B3|Baseline|Total|Total of all reporting groups
473515|NCT00813995|B2|Baseline|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
473516|NCT00813995|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
473517|NCT00813995|P2|Participant Flow|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
473518|NCT00813995|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
473519|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
473520|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
475629|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
473521|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
473522|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
473523|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
473524|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
473525|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
473526|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
473527|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
473528|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
473529|NCT00813995|E2|Reported Event|Placebo|
473530|NCT00813995|E1|Reported Event|Sitagliptin|
473531|NCT00813982|B1|Baseline|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
473532|NCT00813982|P1|Participant Flow|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
473533|NCT00813982|O2|Outcome|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
473534|NCT00813982|O1|Outcome|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
473535|NCT00813982|E2|Reported Event|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens
473536|NCT00813982|E1|Reported Event|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens
473537|NCT00813943|B4|Baseline|Total|Total of all reporting groups
473538|NCT00813943|B3|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473539|NCT00813943|B2|Baseline|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473540|NCT00813943|B1|Baseline|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473541|NCT00813943|P3|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473542|NCT00813943|P2|Participant Flow|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473543|NCT00813943|P1|Participant Flow|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473544|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473594|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473545|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473546|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473547|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473548|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473549|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473550|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473551|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473552|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473553|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473554|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473555|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473556|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473557|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473558|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473559|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473560|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473561|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473562|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473563|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473564|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473565|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473566|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473930|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
473567|NCT00813943|E3|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
473568|NCT00813943|E2|Reported Event|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473569|NCT00813943|E1|Reported Event|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
473570|NCT00813917|B3|Baseline|Total|Total of all reporting groups
473571|NCT00813917|B2|Baseline|Placebo|nonactive lookalike pill per day for 12 weeks
473572|NCT00813917|B1|Baseline|Varenicline|varenicline-1mg/day for 12 weeks
473573|NCT00813917|P2|Participant Flow|Placebo|nonactive lookalike pill per day for 12 weeks
473574|NCT00813917|P1|Participant Flow|Varenicline|varenicline-1mg/day for 12 weeks
473575|NCT00813917|O2|Outcome|Placebo|nonactive lookalike pill per day for 12 weeks
473576|NCT00813917|O1|Outcome|Varenicline|varenicline-1mg/day for 12 weeks
473577|NCT00813917|E2|Reported Event|Placebo|nonactive lookalike pill per day for 12 weeks
473578|NCT00813917|E1|Reported Event|Varenicline|varenicline-1mg/day for 12 weeks
473579|NCT00813904|B1|Baseline|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
473580|NCT00813904|P1|Participant Flow|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
473581|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
473582|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
473583|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
473584|NCT00813904|E1|Reported Event|TOTAL|
473585|NCT00813813|B3|Baseline|Total|Total of all reporting groups
473586|NCT00813813|B2|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473587|NCT00813813|B1|Baseline|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473588|NCT00813813|P2|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473589|NCT00813813|P1|Participant Flow|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473590|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473591|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473592|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473593|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473619|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473595|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473596|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473597|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473598|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473599|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473600|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473601|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473602|NCT00813813|E2|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473603|NCT00813813|E1|Reported Event|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
473604|NCT00813800|B1|Baseline|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
473605|NCT00813800|P1|Participant Flow|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
473606|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
473607|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
473608|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
473609|NCT00813800|E1|Reported Event|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
473610|NCT00813761|B3|Baseline|Total|Total of all reporting groups
473611|NCT00813761|B2|Baseline|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473612|NCT00813761|B1|Baseline|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473613|NCT00813761|P4|Participant Flow|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
473614|NCT00813761|P3|Participant Flow|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
473615|NCT00813761|P2|Participant Flow|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
473616|NCT00813761|P1|Participant Flow|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
473617|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473618|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473931|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
475735|NCT00809757|B1|Baseline|Placebo|Placebo Placebo MDI TID
473620|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473621|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473622|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473623|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473624|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473625|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473626|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473627|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473628|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
473629|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473630|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473631|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473632|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473633|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473634|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473635|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473636|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473637|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473638|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473639|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473640|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473641|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473642|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473643|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473644|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473645|NCT00813761|O2|Outcome|ReNU MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
473646|NCT00813761|O1|Outcome|Clear Care LCS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
473647|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473648|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473649|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473650|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473651|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473652|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473653|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473654|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473655|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
473656|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
473657|NCT00813761|O2|Outcome|ReNU Multi Purpose Solution (MPS)|All subjects assigned to ReNU MPS
473658|NCT00813761|O1|Outcome|Clear Care Lens Cleaning Solution (LCS)|All subjects assigned to Clear Care LCS
473659|NCT00813761|E4|Reported Event|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
473660|NCT00813761|E3|Reported Event|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
473661|NCT00813761|E2|Reported Event|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose
473662|NCT00813761|E1|Reported Event|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
473663|NCT00813748|B3|Baseline|Total|Total of all reporting groups
473664|NCT00813748|B2|Baseline|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
473665|NCT00813748|B1|Baseline|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473932|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
473666|NCT00813748|P2|Participant Flow|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
473667|NCT00813748|P1|Participant Flow|Omalizumab Cases|Participants who received omalizumab (Xolair) and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473668|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
473669|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473670|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
473671|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473672|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
473673|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473674|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
473675|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473676|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473677|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473678|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473679|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473680|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473681|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473682|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473683|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473684|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473685|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473686|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473687|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473688|NCT00813748|E4|Reported Event|Skin Test Substudy: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
473689|NCT00813748|E3|Reported Event|Skin Test Substudy: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473690|NCT00813748|E2|Reported Event|Observational Study: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
473691|NCT00813748|E1|Reported Event|Observational Study: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
473692|NCT00813709|B4|Baseline|Total|Total of all reporting groups
473693|NCT00813709|B3|Baseline|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (18 participants from DB converted to CDMS and switched to OL period over course of this study)
473694|NCT00813709|B2|Baseline|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (26 participants from DB converted to CDMS and switched to OL period over course of this study)
473695|NCT00813709|B1|Baseline|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (9 participants from DB converted to CDMS and switched to OL period over course of this study)
473696|NCT00813709|P6|Participant Flow|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
473697|NCT00813709|P5|Participant Flow|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
473698|NCT00813709|P4|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
473699|NCT00813709|P3|Participant Flow|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473700|NCT00813709|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473701|NCT00813709|P1|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
476861|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
473702|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473703|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473704|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
473705|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473706|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473707|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
473708|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473709|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473710|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473711|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473712|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473713|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473933|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
473934|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473935|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
473936|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
473714|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473715|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473716|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473717|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473718|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473719|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473720|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473721|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473722|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473723|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473937|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473938|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
473724|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473725|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473726|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
473727|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
473728|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
473729|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
473730|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
473731|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
473799|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473939|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
473732|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473733|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473734|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473735|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473736|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473737|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
473738|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
473739|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
473740|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
473741|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
473742|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
473743|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
473800|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473940|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473941|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
473744|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473745|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473746|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473747|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473748|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473749|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473750|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473751|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473752|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473753|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473942|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
473943|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473754|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473755|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473756|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473757|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473758|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473759|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473760|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473761|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473762|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473763|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473944|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
476862|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
473764|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473765|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473766|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473767|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473768|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473769|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473770|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473771|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473772|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473784|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473773|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
473774|NCT00813709|E6|Reported Event|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
473775|NCT00813709|E5|Reported Event|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
473776|NCT00813709|E4|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
473777|NCT00813709|E3|Reported Event|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473778|NCT00813709|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
473779|NCT00813709|E1|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
473780|NCT00813592|B1|Baseline|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473781|NCT00813592|P1|Participant Flow|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473782|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473783|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473945|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
473946|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473785|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473786|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473787|NCT00813592|O1|Outcome|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473788|NCT00813592|E1|Reported Event|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
473789|NCT00813488|B1|Baseline|Total Number of Patients|
473790|NCT00813488|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Subjects in this treatment group were assigned 15 mg oxycodone during the first titration period and then 200 mcg FBT during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
473791|NCT00813488|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Subjects in this treatment group were assigned 200 mcg FBT during the first titration period and then 15 mg oxycodone during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
473792|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473793|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473794|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473795|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473796|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473797|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473798|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473947|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
473948|NCT00813098|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake
473801|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473802|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473803|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473804|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473805|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473806|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
473807|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473808|NCT00813488|O1|Outcome|Total|"Includes all patients who participated in the double-blind treatment period and completed treatment.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473809|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473810|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473811|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473812|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473813|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473814|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473815|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473949|NCT00813098|E2|Reported Event|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473816|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473817|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473818|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473819|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473820|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473821|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473822|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473823|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473824|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473825|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473826|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473838|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473827|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473828|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473829|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473830|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473831|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473832|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473833|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473834|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473835|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473836|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473837|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473950|NCT00813098|E1|Reported Event|High Dose|A high dose of LX1031; daily oral intake for 28 days
473951|NCT00812981|B3|Baseline|Total|Total of all reporting groups
473952|NCT00812981|B2|Baseline|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473839|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473840|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473841|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473842|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473843|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473844|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473845|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473846|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473847|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473848|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473849|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473953|NCT00812981|B1|Baseline|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
474010|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
473850|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473851|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473852|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473853|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473854|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473855|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473856|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473857|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473858|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473859|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473860|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473872|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473861|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473862|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473863|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473864|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473865|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473866|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473867|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473868|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473869|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473870|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473871|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473922|NCT00813111|E1|Reported Event|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
473923|NCT00813098|B4|Baseline|Total|Total of all reporting groups
473924|NCT00813098|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake
473925|NCT00813098|B2|Baseline|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473873|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473874|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473875|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473876|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473877|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473878|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473879|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473880|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473881|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
473882|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
473883|NCT00813488|E3|Reported Event|Standard of Care|21 subjects received standard of care analgesics apart from oxycodone or FBT during the Open-Label Extension Period. Subjects who took oxycodone during SOC are listed under Oxycodone.
473884|NCT00813488|E2|Reported Event|Oxycodone|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period (they were only exposed to one drug). 213 subjects began the first titration period and of those 27 discontinued before exposure to oxycodone. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 186 subjects had exposure to oxycodone
473926|NCT00813098|B1|Baseline|High Dose|A high dose of LX1031; daily oral intake for 28 days
473885|NCT00813488|E1|Reported Event|Fentanyl Buccal Tablet|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period. 213 subjects began the first titration period and of those 17 discontinued before exposure to FBT. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 196 subjects had exposure to FBT
473886|NCT00813319|B3|Baseline|Total|Total of all reporting groups
473887|NCT00813319|B2|Baseline|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
473888|NCT00813319|B1|Baseline|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
473889|NCT00813319|P2|Participant Flow|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
473890|NCT00813319|P1|Participant Flow|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
473891|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
473892|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
473893|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
473894|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
473895|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
473896|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
473897|NCT00813319|E2|Reported Event|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
473898|NCT00813319|E1|Reported Event|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
473899|NCT00813150|B3|Baseline|Total|Total of all reporting groups
473900|NCT00813150|B2|Baseline|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
473901|NCT00813150|B1|Baseline|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
473927|NCT00813098|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake
473902|NCT00813150|P2|Participant Flow|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
473903|NCT00813150|P1|Participant Flow|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
473904|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
473905|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
473906|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
473907|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
473908|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
473909|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
473910|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
473911|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
473912|NCT00813150|E2|Reported Event|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
473913|NCT00813150|E1|Reported Event|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
473914|NCT00813111|B3|Baseline|Total|Total of all reporting groups
473915|NCT00813111|B2|Baseline|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
473916|NCT00813111|B1|Baseline|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
473917|NCT00813111|P2|Participant Flow|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
473918|NCT00813111|P1|Participant Flow|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
473919|NCT00813111|O2|Outcome|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
473920|NCT00813111|O1|Outcome|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
473921|NCT00813111|E2|Reported Event|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
473928|NCT00813098|P2|Participant Flow|Low Dose|A low dose of LX1031; daily oral intake for 28 days
473954|NCT00812981|P2|Participant Flow|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473955|NCT00812981|P1|Participant Flow|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473956|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473957|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473958|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473959|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473960|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473961|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473962|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473963|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473964|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473965|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473966|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473967|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473968|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473969|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473970|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473971|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473972|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473973|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473974|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473975|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473976|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473977|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473978|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
474647|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
473979|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473980|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473981|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473982|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473983|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473984|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473985|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473986|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473987|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473988|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473989|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473990|NCT00812981|E2|Reported Event|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473991|NCT00812981|E1|Reported Event|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
473992|NCT00812968|B1|Baseline|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
473993|NCT00812968|P1|Participant Flow|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle. Treatment continued until disease progression or relapse following an erythroid improvement was documented, any of the criteria for treatment discontinuation was violated, or lenalidomide became commercially available for the treatment of MDS associated with a del (5q) cytogenetic abnormality, for up to 156 weeks (3 years).
473994|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
473995|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
473996|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
473997|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
473998|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
473999|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474000|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474001|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474002|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474003|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474004|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
474005|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474006|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
474007|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474008|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
474009|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474648|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474011|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474012|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474013|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
474014|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474015|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
474016|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474017|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
474018|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474019|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
474020|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
474021|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474022|NCT00812968|E1|Reported Event|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
474023|NCT00812955|B5|Baseline|Total|Total of all reporting groups
474024|NCT00812955|B4|Baseline|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
474025|NCT00812955|B3|Baseline|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
474026|NCT00812955|B2|Baseline|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
474027|NCT00812955|B1|Baseline|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
474028|NCT00812955|P4|Participant Flow|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
474029|NCT00812955|P3|Participant Flow|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
474030|NCT00812955|P2|Participant Flow|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
474031|NCT00812955|P1|Participant Flow|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
474032|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
474033|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
474034|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
474035|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
474036|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
474037|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
474038|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
474039|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
474040|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg
474041|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
474042|NCT00812955|O2|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg
474043|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
474044|NCT00812955|O2|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg
474045|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
474046|NCT00812955|E4|Reported Event|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
474047|NCT00812955|E3|Reported Event|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
474048|NCT00812955|E2|Reported Event|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
474049|NCT00812955|E1|Reported Event|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
474050|NCT00812929|B1|Baseline|Total|Eligible participants completed five treatment periods (single dose 10 mg, 50 mg, 100 mg, 200 mg GSK2190915 oral solution, compared to placebo control which was administered on Day 1 of each treatment period). Each treatment period lasted 2 days, with a minimum 7 day washout period between each treatment periods.
474051|NCT00812929|P10|Participant Flow|B/A/C/P/D|In this sequence participants received treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 1, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 2, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 3, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 4, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474052|NCT00812929|P9|Participant Flow|A/P/B/D/C|In this sequence participants received treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 1, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 2, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 3, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 4, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
476863|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
474053|NCT00812929|P8|Participant Flow|P/D/A/C/B|In this sequence participants received treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 1, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 2, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 3, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 4, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474054|NCT00812929|P7|Participant Flow|D/C/P/B/A|In this sequence participants received treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 1, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 2, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 3, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 4, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474055|NCT00812929|P6|Participant Flow|C/B/D/A/P|In this sequence participants received treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 1, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 2, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 3, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 4, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474056|NCT00812929|P5|Participant Flow|D/P/C/A/B|In this sequence participants received treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 1, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 2, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 3, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 4, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474057|NCT00812929|P4|Participant Flow|C/D/B/P/A|In this sequence participants received treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 1, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 2, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 3, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 4, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474058|NCT00812929|P3|Participant Flow|B/C/A/D/P|In this sequence participants received treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 1, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 2, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 3, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 4, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474059|NCT00812929|P2|Participant Flow|A/B/P/C/D|In this sequence participants received treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 1, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 2, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 3, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 4 and treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474060|NCT00812929|P1|Participant Flow|P/A/D/B/C|In this sequence participants received treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 1, treatment A of oral single dose of aqueous solution of 10 milligrams (mg) GSK2190915 on Day 1 of treatment period 2, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 3, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 4 and treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
474061|NCT00812929|O4|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474062|NCT00812929|O3|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474063|NCT00812929|O2|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474064|NCT00812929|O1|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474065|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474066|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474067|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474068|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474069|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474070|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474071|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474072|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474073|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474074|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474075|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474076|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474077|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474078|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474079|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474080|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474081|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474082|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474083|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474084|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474085|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474086|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474087|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474088|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474089|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474090|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474091|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474092|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474093|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474094|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474095|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474096|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474097|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474098|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474099|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474649|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474100|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474101|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474102|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474103|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474104|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474105|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474106|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474107|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474108|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474109|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474110|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474111|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474112|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474113|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474114|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474115|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474116|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474117|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474118|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474119|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474120|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474121|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474122|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474123|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474124|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474125|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474126|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474127|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474128|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474129|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474130|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474131|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474132|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474133|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474134|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474650|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474135|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474136|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474137|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474138|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474139|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474140|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474141|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474142|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474143|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474144|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474145|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474146|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474147|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474148|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474149|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474150|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474151|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474152|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474153|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474154|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474155|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474156|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474157|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474158|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474159|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474160|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474161|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474162|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474163|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474164|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474165|NCT00812929|O5|Outcome|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474166|NCT00812929|O4|Outcome|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474167|NCT00812929|O3|Outcome|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474168|NCT00812929|O2|Outcome|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of each treatment period.
474169|NCT00812929|O1|Outcome|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 milliliter (mL) of water on Day 1 of each treatment period.
477557|NCT00806195|B5|Baseline|Total|Total of all reporting groups
474170|NCT00812929|E5|Reported Event|GSK2190915 200 mg|Eligible participants received single dose 200 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
474171|NCT00812929|E4|Reported Event|GSK2190915 100 mg|Eligible participants received single dose 100 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
474172|NCT00812929|E3|Reported Event|GSK2190915 50 mg|Eligible participants received single dose 50 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
474173|NCT00812929|E2|Reported Event|GSK2190915 10 mg|Eligible participants received single dose 10 mg GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
474174|NCT00812929|E1|Reported Event|Placebo|Eligible participants received Placebo matching GSK2190915 oral solution which was administered with 100 mL of water on Day 1 of the treatment period.
474175|NCT00812916|B1|Baseline|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
474176|NCT00812916|P1|Participant Flow|Number of Patients|Radiofrequency (RF) Ablation using specialized complex fractionated atrial electrogram (CFAE) software
474177|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
474178|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
474179|NCT00812916|O1|Outcome|RF Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
474180|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
474181|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
474182|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
474183|NCT00812916|E1|Reported Event|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
474184|NCT00812877|B3|Baseline|Total|Total of all reporting groups
474185|NCT00812877|B2|Baseline|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
474186|NCT00812877|B1|Baseline|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
474187|NCT00812877|P2|Participant Flow|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
474188|NCT00812877|P1|Participant Flow|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
474189|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
474190|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
474191|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
474192|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
474193|NCT00812877|E2|Reported Event|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
474194|NCT00812877|E1|Reported Event|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
474195|NCT00812812|B3|Baseline|Total|Total of all reporting groups
474196|NCT00812812|B2|Baseline|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474197|NCT00812812|B1|Baseline|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
474198|NCT00812812|P2|Participant Flow|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474199|NCT00812812|P1|Participant Flow|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
474200|NCT00812812|O1|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474201|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474202|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
474240|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474241|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474242|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474203|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474204|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
474205|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474206|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
474207|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474208|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
474209|NCT00812812|E2|Reported Event|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
474210|NCT00812812|E1|Reported Event|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
474211|NCT00812604|B3|Baseline|Total|Total of all reporting groups
474212|NCT00812604|B2|Baseline|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
474213|NCT00812604|B1|Baseline|Ping On Ointment Group|Ping On Ointment was used
474214|NCT00812604|P2|Participant Flow|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
474215|NCT00812604|P1|Participant Flow|Ping On Ointment Group|Ping On Ointment was used
474216|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
474217|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
474218|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
474219|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
474220|NCT00812604|E2|Reported Event|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
474221|NCT00812604|E1|Reported Event|Ping On Ointment Group|Ping On Ointment was used
474222|NCT00812565|B9|Baseline|Total|Total of all reporting groups
474223|NCT00812565|B8|Baseline|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474224|NCT00812565|B7|Baseline|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474225|NCT00812565|B6|Baseline|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474226|NCT00812565|B5|Baseline|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474227|NCT00812565|B4|Baseline|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474228|NCT00812565|B3|Baseline|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474229|NCT00812565|B2|Baseline|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474230|NCT00812565|B1|Baseline|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474231|NCT00812565|P8|Participant Flow|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474232|NCT00812565|P7|Participant Flow|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474233|NCT00812565|P6|Participant Flow|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474234|NCT00812565|P5|Participant Flow|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474235|NCT00812565|P4|Participant Flow|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474236|NCT00812565|P3|Participant Flow|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474237|NCT00812565|P2|Participant Flow|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474238|NCT00812565|P1|Participant Flow|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474239|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
478535|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
474243|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474244|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474245|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474246|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474247|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474248|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474249|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474250|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474251|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474252|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474253|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474254|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474255|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474256|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474257|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474258|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474259|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474260|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474261|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474262|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474263|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474264|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474265|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474266|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474267|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474268|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474269|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474270|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474271|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474272|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474273|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474274|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474275|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474276|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474277|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474278|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474279|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474280|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474281|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474282|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474283|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474284|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474285|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474286|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474287|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474288|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474289|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474290|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474291|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474292|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474293|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474294|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474295|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474296|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474297|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474298|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474299|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474300|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474301|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474302|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474303|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474304|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474305|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474306|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474307|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474308|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474309|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474310|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474311|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474312|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474313|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474314|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474315|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474316|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474317|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474318|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474319|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474320|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474321|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474322|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474323|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474324|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474325|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474326|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474327|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474328|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474329|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474330|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474331|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474332|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474333|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474334|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474335|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474336|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474337|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474338|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474339|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474340|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474341|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474342|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474343|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474344|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474345|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474346|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474347|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474348|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474349|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474350|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474351|NCT00812565|E8|Reported Event|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474352|NCT00812565|E7|Reported Event|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
474353|NCT00812565|E6|Reported Event|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474354|NCT00812565|E5|Reported Event|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
474355|NCT00812565|E4|Reported Event|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474356|NCT00812565|E3|Reported Event|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
474357|NCT00812565|E2|Reported Event|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474358|NCT00812565|E1|Reported Event|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
474359|NCT00812487|B3|Baseline|Total|Total of all reporting groups
474360|NCT00812487|B2|Baseline|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474361|NCT00812487|B1|Baseline|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474362|NCT00812487|P2|Participant Flow|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474363|NCT00812487|P1|Participant Flow|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474364|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474365|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474366|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474367|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474368|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474369|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474370|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474371|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
478536|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
474372|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474373|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474374|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474375|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474376|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474377|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474378|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474379|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474380|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474381|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474382|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474383|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474384|NCT00812487|E2|Reported Event|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
474385|NCT00812487|E1|Reported Event|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
474386|NCT00812461|B3|Baseline|Total|Total of all reporting groups
474387|NCT00812461|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474388|NCT00812461|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
474389|NCT00812461|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474390|NCT00812461|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
474391|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474392|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474393|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474394|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474395|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474396|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474397|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474398|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474399|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474400|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474401|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474402|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474403|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474404|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474405|NCT00812461|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474406|NCT00812461|E1|Reported Event|Placebo|as-needed use, tablets, orally, 6 months
474407|NCT00812331|B6|Baseline|Total|Total of all reporting groups
474408|NCT00812331|B5|Baseline|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474409|NCT00812331|B4|Baseline|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474410|NCT00812331|B3|Baseline|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474411|NCT00812331|B2|Baseline|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474412|NCT00812331|B1|Baseline|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474413|NCT00812331|P5|Participant Flow|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474414|NCT00812331|P4|Participant Flow|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474415|NCT00812331|P3|Participant Flow|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474416|NCT00812331|P2|Participant Flow|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474417|NCT00812331|P1|Participant Flow|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474418|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474419|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474420|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474421|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474651|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474422|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474423|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474424|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474425|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474426|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474427|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474428|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474429|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474430|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474431|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474432|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474433|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474434|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474435|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474436|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474437|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474438|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474439|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474440|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474441|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474442|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474443|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474444|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474445|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474446|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474447|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474448|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474449|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474450|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474451|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474452|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474453|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474454|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474455|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474456|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474457|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474458|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474459|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
478537|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
474460|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474461|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474462|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474463|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474464|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474465|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474466|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474467|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474468|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474469|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474470|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474471|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474472|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474473|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474474|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474475|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474476|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474477|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474478|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474479|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474480|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474481|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474482|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474483|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474484|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474485|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474486|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474487|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
474488|NCT00812331|E1|Reported Event|Total|Participants with chronic genotype 2,3,4,5 or 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
474489|NCT00812253|B3|Baseline|Total|Total of all reporting groups
474490|NCT00812253|B2|Baseline|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474491|NCT00812253|B1|Baseline|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474566|NCT00811954|B3|Baseline|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474652|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
478538|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
474492|NCT00812253|P2|Participant Flow|Subcutaneous Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474493|NCT00812253|P1|Participant Flow|Intravenous Insulin (IV)|Intravenous insulin: In patients assigned to intravenous (IV) insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474494|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474495|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474496|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474497|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474498|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474499|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474500|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474501|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474502|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474503|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474504|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474505|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474506|NCT00812253|E2|Reported Event|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
474507|NCT00812253|E1|Reported Event|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
474508|NCT00812110|B1|Baseline|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
474509|NCT00812110|P1|Participant Flow|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
474510|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
474511|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
474512|NCT00812110|E1|Reported Event|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
474513|NCT00812097|B5|Baseline|Total|Total of all reporting groups
474514|NCT00812097|B4|Baseline|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474515|NCT00812097|B3|Baseline|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474516|NCT00812097|B2|Baseline|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474517|NCT00812097|B1|Baseline|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474518|NCT00812097|P4|Participant Flow|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474519|NCT00812097|P3|Participant Flow|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474567|NCT00811954|B2|Baseline|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474653|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474654|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474520|NCT00812097|P2|Participant Flow|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474521|NCT00812097|P1|Participant Flow|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474522|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474523|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474524|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474525|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474526|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474527|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474528|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474529|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474530|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474531|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474643|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474532|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474533|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474534|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474535|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474536|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474537|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474538|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474539|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474540|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474541|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474542|NCT00812097|E4|Reported Event|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474543|NCT00812097|E3|Reported Event|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474644|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474544|NCT00812097|E2|Reported Event|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474545|NCT00812097|E1|Reported Event|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
474546|NCT00812006|B4|Baseline|Total|Total of all reporting groups
474547|NCT00812006|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
474548|NCT00812006|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
474549|NCT00812006|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
474550|NCT00812006|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
474551|NCT00812006|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
474552|NCT00812006|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
474553|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
474554|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
474555|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
474556|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
474557|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
474558|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
474559|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
474560|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
474561|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
474562|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
474563|NCT00812006|E2|Reported Event|Placebo|"Placebo. Patients who treated an attack with placebo were included. Adverse events occurring within 14 days of administration of placebo, but not within 14 days of any administration of rizatriptan (including sponsor-provided rescue), were attributed to placebo group.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
474564|NCT00812006|E1|Reported Event|Rizatriptan|"Rizatriptan 10 mg. Patients who treated at least one attack with rizatriptan 10 mg (including sponsor-provided rescue) were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group. Adverse events occurring within 14 days of any administration of rizatriptan (including sponsor-provided rescue) were attributed to rizatriptan group, even if placebo was administered more recently.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
474565|NCT00811954|B4|Baseline|Total|Total of all reporting groups
478539|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
474568|NCT00811954|B1|Baseline|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474569|NCT00811954|P3|Participant Flow|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474570|NCT00811954|P2|Participant Flow|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474571|NCT00811954|P1|Participant Flow|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474572|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474573|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474574|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474575|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474576|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474577|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474578|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474579|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474580|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474581|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474582|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474583|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474584|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474585|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474586|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474587|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474588|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474589|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474645|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474646|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474590|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474591|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474592|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474593|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474594|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474595|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474596|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474597|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474598|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474599|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474600|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474601|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474602|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474603|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474604|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474605|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474606|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474607|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474608|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474609|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474610|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474611|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474612|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474613|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474614|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474615|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474616|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474617|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474618|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474619|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474620|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474621|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474622|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474623|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474624|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474625|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474626|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474627|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474628|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474629|NCT00811954|E3|Reported Event|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
474630|NCT00811954|E2|Reported Event|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
474631|NCT00811954|E1|Reported Event|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
474632|NCT00811941|B3|Baseline|Total|Total of all reporting groups
474633|NCT00811941|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474634|NCT00811941|B1|Baseline|Placebo|as-needed use, tablets, orally, 52 weeks
474635|NCT00811941|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474636|NCT00811941|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 52 weeks
474637|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474638|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474639|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474640|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474641|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474642|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474655|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474656|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474657|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474658|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474659|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474660|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474661|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474662|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474663|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474664|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474665|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474666|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474667|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474668|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
474669|NCT00811941|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
474670|NCT00811941|E1|Reported Event|Placebo|as-needed use, tablets, orally, 52 weeks
474671|NCT00811928|B3|Baseline|Total|Total of all reporting groups
474672|NCT00811928|B2|Baseline|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474673|NCT00811928|B1|Baseline|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474674|NCT00811928|P2|Participant Flow|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474675|NCT00811928|P1|Participant Flow|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474676|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474677|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474678|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474679|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474680|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474681|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474682|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474683|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474684|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474685|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474686|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474687|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474688|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474689|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474690|NCT00811928|E2|Reported Event|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
474691|NCT00811928|E1|Reported Event|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
474692|NCT00811850|B1|Baseline|All Patients|All patients in the study
474693|NCT00811850|P1|Participant Flow|All Patients|This was a cross-over study with 3 treatment periods. In Treatment Period 1, patients received either Combigan® or Cosopt®. In Treatment Period 2, patients were washed out of their previous treatment. In Treatment Period 3, patients received either Combigan® or Cosopt® (treatment not received in Treatment Period 1).
474694|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474695|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474696|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474697|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474698|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474699|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474700|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474701|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474702|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474703|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474704|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474705|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474706|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474707|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474708|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474709|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474710|NCT00811850|E2|Reported Event|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474711|NCT00811850|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
474712|NCT00811798|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
474713|NCT00811798|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
474714|NCT00811798|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
474715|NCT00811798|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
474716|NCT00811733|B3|Baseline|Total|Total of all reporting groups
474717|NCT00811733|B2|Baseline|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474718|NCT00811733|B1|Baseline|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474719|NCT00811733|P2|Participant Flow|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474720|NCT00811733|P1|Participant Flow|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474795|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474796|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
475323|NCT00810641|P2|Participant Flow|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
474721|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474722|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474723|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474724|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474725|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474726|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474727|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474728|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474729|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474730|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474731|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474732|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474733|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474734|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474735|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474736|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474737|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474738|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474739|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474740|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474741|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474742|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474743|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474744|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474745|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474746|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474747|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474748|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474749|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474750|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474751|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474752|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474753|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474754|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474755|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474756|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474757|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474758|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474759|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474760|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474761|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474762|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474763|NCT00811733|E2|Reported Event|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
474764|NCT00811733|E1|Reported Event|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
474765|NCT00811720|B3|Baseline|Total|Total of all reporting groups
474766|NCT00811720|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474767|NCT00811720|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
474768|NCT00811720|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474769|NCT00811720|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
474770|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474771|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474772|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474773|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474774|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474775|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474776|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474777|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474778|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474779|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474780|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474781|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474782|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
474783|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
474784|NCT00811720|E2|Reported Event|Nalmefene 18.06 mg|
474785|NCT00811720|E1|Reported Event|Placebo|
474786|NCT00811655|B1|Baseline|Pre-OP SRS|"SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
474787|NCT00811655|P1|Participant Flow|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
474788|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474789|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474790|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474791|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474792|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474793|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474794|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
474797|NCT00811655|E1|Reported Event|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
474798|NCT00811642|B1|Baseline|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474799|NCT00811642|P1|Participant Flow|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474800|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474801|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474802|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474803|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474804|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474805|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474806|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
474807|NCT00811642|E1|Reported Event|POSACONAZOLE|400mg oral suspension BID for 12 weeks
474808|NCT00811590|B1|Baseline|All Patients|All patients enrolled/eligible.
474809|NCT00811590|P1|Participant Flow|All Patients|All patients enrolled/eligible.
474810|NCT00811590|O1|Outcome|All Patients|All enrolled/eligible patients.
474811|NCT00811590|E1|Reported Event|All Patients|All enrolled/eligible patients.
474812|NCT00811577|B3|Baseline|Total|Total of all reporting groups
474813|NCT00811577|B2|Baseline|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
474814|NCT00811577|B1|Baseline|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
474815|NCT00811577|P2|Participant Flow|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
474816|NCT00811577|P1|Participant Flow|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
474817|NCT00811577|O3|Outcome|Alpha SMA Results for 10 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474818|NCT00811577|O2|Outcome|Alpha SMA Results for 3 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474819|NCT00811577|O1|Outcome|Alpha SMA Results for Placebo Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474820|NCT00811577|O9|Outcome|Collagen Fiber Orientation Results for 10 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474821|NCT00811577|O8|Outcome|Collagen Fiber Orientation Results for 3 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474822|NCT00811577|O7|Outcome|Collagen Fiber Orientation Results for Placebo Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474823|NCT00811577|O6|Outcome|Collagen Fiber Maturity Results for 10 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474824|NCT00811577|O5|Outcome|Collagen Fiber Maturity Results for 3 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474825|NCT00811577|O4|Outcome|Collagen Fiber Maturity Results for Placebo Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474826|NCT00811577|O3|Outcome|Collagen Fiber Density Results for 10 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474827|NCT00811577|O2|Outcome|Collagen Fiber Density Results for 3 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474828|NCT00811577|O1|Outcome|Collagen Fiber Density Results for Placebo Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474829|NCT00811577|O9|Outcome|Scar Total Volume for 10 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474830|NCT00811577|O8|Outcome|Scar Total Volume for 3 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474831|NCT00811577|O7|Outcome|Scar Total Volume for Placebo Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474832|NCT00811577|O6|Outcome|Scar Negative Volume for 10 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474918|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
478540|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
474833|NCT00811577|O5|Outcome|Scar Negative Volume for 3 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474834|NCT00811577|O4|Outcome|Scar Negative Volume for Placebo Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474835|NCT00811577|O3|Outcome|Scar Positive Volume for 10 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474836|NCT00811577|O2|Outcome|Scar Positive Volume for 3 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474837|NCT00811577|O1|Outcome|Scar Positive Volume for Placebo Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474838|NCT00811577|O12|Outcome|Scar Maximum Elevation for 10 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474839|NCT00811577|O11|Outcome|Scar Maximum Elevation for 3 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474840|NCT00811577|O10|Outcome|Scar Maximum Elevation for Placebo Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474841|NCT00811577|O9|Outcome|Scar Minimum Elevation for 10 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474842|NCT00811577|O8|Outcome|Scar Minimum Elevation for 3 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474843|NCT00811577|O7|Outcome|Scar Minimum Elevation for Placebo Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 saline placebo/cm at 9 days and 21 days following shoulder surgery.
474844|NCT00811577|O6|Outcome|Scar Width for 10 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474845|NCT00811577|O5|Outcome|Scar Width for 3 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474846|NCT00811577|O4|Outcome|Scar Width for Placebo Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474847|NCT00811577|O3|Outcome|Scar Length for 10 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474848|NCT00811577|O2|Outcome|Scar Length for 3 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474849|NCT00811577|O1|Outcome|Scar Length for Placebo Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474850|NCT00811577|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474851|NCT00811577|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474852|NCT00811577|O4|Outcome|Rater 2 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474853|NCT00811577|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474854|NCT00811577|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474855|NCT00811577|O1|Outcome|Rater 1 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474856|NCT00811577|O6|Outcome|OSAS Results for 10 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474857|NCT00811577|O5|Outcome|OSAS Results for 3 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474858|NCT00811577|O4|Outcome|OSAS Results for Placebo Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474859|NCT00811577|O3|Outcome|PSAS Results for 10 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
474919|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474860|NCT00811577|O2|Outcome|PSAS Results for 3 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
474861|NCT00811577|O1|Outcome|PSAS Results for Placebo Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
474862|NCT00811577|E2|Reported Event|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
474863|NCT00811577|E1|Reported Event|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
474864|NCT00811564|B3|Baseline|Total|Total of all reporting groups
474865|NCT00811564|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
474866|NCT00811564|B1|Baseline|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
474867|NCT00811564|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
474868|NCT00811564|P1|Participant Flow|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
474869|NCT00811564|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
474870|NCT00811564|O1|Outcome|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
474871|NCT00811564|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
474872|NCT00811564|E1|Reported Event|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
474873|NCT00811473|B3|Baseline|Total|Total of all reporting groups
474874|NCT00811473|B2|Baseline|Placebo|Matching placebo
474875|NCT00811473|B1|Baseline|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474876|NCT00811473|P2|Participant Flow|Placebo|Matching placebo
474877|NCT00811473|P1|Participant Flow|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474878|NCT00811473|O2|Outcome|Placebo|Matching placebo
474879|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474880|NCT00811473|O2|Outcome|Placebo|Matching placebo
474881|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474882|NCT00811473|O2|Outcome|Placebo|Matching placebo
474883|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474884|NCT00811473|O2|Outcome|Placebo|Matching placebo
474885|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474886|NCT00811473|O2|Outcome|Placebo|Matching placebo
474887|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474888|NCT00811473|O2|Outcome|Placebo|Matching placebo
474889|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474890|NCT00811473|E2|Reported Event|Placebo|Matching placebo
474891|NCT00811473|E1|Reported Event|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
474892|NCT00811434|B1|Baseline|All Participants|all aprticipants who were randomized to receive treatment
474893|NCT00811434|P2|Participant Flow|Placebo First, Then Lactulose|Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight
474894|NCT00811434|P1|Participant Flow|Lactulose First, Then Placebo|Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day
474895|NCT00811434|O2|Outcome|Placebo|1.5 ml/kg day po of sugar water placebo for three months
474896|NCT00811434|O1|Outcome|Lactulose|3 months of Lactulose therapy based on pt. weight
474897|NCT00811434|O1|Outcome|All Randomized Participants|
474898|NCT00811434|O1|Outcome|All Randomized Participants|
474899|NCT00811434|E2|Reported Event|Placebo|1.5 ml/kg day po of sugar water placebo for three months
474900|NCT00811434|E1|Reported Event|Lactulose|3 months of Lactulose therapy based on pt. weight
474901|NCT00811395|B7|Baseline|Total|Total of all reporting groups
474902|NCT00811395|B6|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474903|NCT00811395|B5|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474904|NCT00811395|B4|Baseline|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474905|NCT00811395|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474906|NCT00811395|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474907|NCT00811395|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474908|NCT00811395|P6|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474909|NCT00811395|P5|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474910|NCT00811395|P4|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474911|NCT00811395|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474912|NCT00811395|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474913|NCT00811395|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474914|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474915|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474916|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474917|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474920|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474921|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474922|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474923|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474924|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474925|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474926|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474927|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474928|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474929|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474930|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474931|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474932|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474933|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474934|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474935|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474936|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474937|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474938|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474939|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474940|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474941|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474942|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474943|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474944|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474945|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474946|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474947|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474948|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474949|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474950|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474951|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474952|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474953|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474954|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474955|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474956|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
474957|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
474958|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
474959|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474960|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474961|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474962|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
474963|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
474964|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
474965|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474966|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474967|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474968|NCT00811395|E6|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
474969|NCT00811395|E5|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
474970|NCT00811395|E4|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
478541|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
474971|NCT00811395|E3|Reported Event|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
474972|NCT00811395|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
474973|NCT00811395|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
474974|NCT00811382|B3|Baseline|Total|Total of all reporting groups
474975|NCT00811382|B2|Baseline|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)."
474976|NCT00811382|B1|Baseline|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC.~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring."
474977|NCT00811382|P2|Participant Flow|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
474978|NCT00811382|P1|Participant Flow|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
474979|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
474980|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
474981|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
474982|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
474983|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
474984|NCT00811382|O1|Outcome|1: Access to HMSC (Home Monitoring Service Center)|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
474985|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
474986|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
474987|NCT00811382|E2|Reported Event|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
474988|NCT00811382|E1|Reported Event|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
474989|NCT00811317|B1|Baseline|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475324|NCT00810641|P1|Participant Flow|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
475325|NCT00810641|O3|Outcome|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
474990|NCT00811317|P1|Participant Flow|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474991|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474992|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474993|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474994|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474995|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474996|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474997|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474998|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
474999|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475000|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475001|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475002|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475003|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475004|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475005|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475006|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475007|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475008|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475009|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475010|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475011|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475012|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475013|NCT00811317|O1|Outcome|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475014|NCT00811317|E1|Reported Event|Closed-loop|"Type 1 diabetic subjects under closed-loop blood glucose control~Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target"
475015|NCT00811252|B4|Baseline|Total|Total of all reporting groups
475016|NCT00811252|B3|Baseline|Duloxetine 60 mg|encapsulated tablets; daily; orally
475017|NCT00811252|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475018|NCT00811252|B1|Baseline|Placebo|capsules; daily; orally
475019|NCT00811252|P3|Participant Flow|Duloxetine 60 mg|encapsulated tablets; daily; orally
475020|NCT00811252|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475021|NCT00811252|P1|Participant Flow|Placebo|capsules; daily; orally
475022|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475023|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475024|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475025|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475026|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475027|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475028|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475029|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475030|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475031|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475032|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475033|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475034|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475035|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475036|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475037|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475038|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475039|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475040|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475041|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475042|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475043|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475044|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475045|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475046|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475047|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475048|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475049|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475050|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475051|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475052|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475053|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475054|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475055|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475056|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475057|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475058|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
475059|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
475060|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
475061|NCT00811252|E3|Reported Event|Duloxetine 60 mg|
475062|NCT00811252|E2|Reported Event|Vortioxetine 5 mg|
475063|NCT00811252|E1|Reported Event|Placebo|
475064|NCT00811174|B1|Baseline|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475065|NCT00811174|P1|Participant Flow|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475066|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475067|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475068|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475069|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475070|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475071|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475072|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475073|NCT00811174|O1|Outcome|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475074|NCT00811174|E1|Reported Event|Octagam 10%|Octagam 10% : 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
475075|NCT00811135|B1|Baseline|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475110|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475076|NCT00811135|P1|Participant Flow|Trastuzumab + Bevacizumab + Capecitabine|Participants received intravenous (IV) trastuzumab (8 milligrams per kilogram [mg/kg]) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 milligrams per meter square (mg/m^2) twice daily (BID) on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475077|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475078|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475079|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475080|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475081|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475082|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475083|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475084|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475085|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475086|NCT00811135|E1|Reported Event|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
475087|NCT00811070|B7|Baseline|Total|Total of all reporting groups
475088|NCT00811070|B6|Baseline|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475089|NCT00811070|B5|Baseline|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475090|NCT00811070|B4|Baseline|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475091|NCT00811070|B3|Baseline|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475111|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475092|NCT00811070|B2|Baseline|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475093|NCT00811070|B1|Baseline|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475094|NCT00811070|P6|Participant Flow|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475095|NCT00811070|P5|Participant Flow|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475096|NCT00811070|P4|Participant Flow|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475097|NCT00811070|P3|Participant Flow|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475098|NCT00811070|P2|Participant Flow|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475099|NCT00811070|P1|Participant Flow|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475100|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475101|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475102|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475103|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475104|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475105|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475106|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475107|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475108|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475109|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475326|NCT00810641|O2|Outcome|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
475112|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475113|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475114|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475115|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475116|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475117|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475118|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475119|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475120|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475121|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475122|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475123|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475124|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475125|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475126|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
475127|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475128|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475129|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475327|NCT00810641|O1|Outcome|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
475130|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475131|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475132|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475133|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475134|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475135|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475136|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475137|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475138|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475139|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475140|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475141|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475142|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475143|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475144|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475328|NCT00810641|E3|Reported Event|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
475329|NCT00810641|E2|Reported Event|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
475145|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475146|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475147|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475148|NCT00811070|O1|Outcome|All Treated Participants (Part 1 )|All participants who received single oral dose of bosutinib 400 mg, 500 mg or 600 mg on Day 1 and then bosutinib 400 mg, 500 mg or 600 mg orally once daily continuously from Day 3 up to Week 4.
475149|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
475150|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475151|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
475152|NCT00811070|E3|Reported Event|Total Population|Total participants who were second-line or third-line chronic myelogenous leukemia (CML).
475153|NCT00811070|E2|Reported Event|Exploratory Third-line|All participants who received bosutinib 500 mg orally once daily in third-line chronic myelogenous leukemia (CML), participants were with imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant.
475154|NCT00811070|E1|Reported Event|Total Second-line|All participants who received bosutinib orally once daily in second-line chronic myelogenous leukemia (CML), who were imatinib resistant/refractory/intolerant.
475155|NCT00811057|B4|Baseline|Total|Total of all reporting groups
475156|NCT00811057|B3|Baseline|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
475157|NCT00811057|B2|Baseline|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
475158|NCT00811057|B1|Baseline|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
475159|NCT00811057|P3|Participant Flow|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
475160|NCT00811057|P2|Participant Flow|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
475161|NCT00811057|P1|Participant Flow|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
475162|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
475163|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
475164|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
475330|NCT00810641|E1|Reported Event|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
475630|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475165|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
475166|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
475167|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
475168|NCT00811057|E3|Reported Event|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
475169|NCT00811057|E2|Reported Event|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
475170|NCT00811057|E1|Reported Event|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
475171|NCT00811018|B1|Baseline|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475172|NCT00811018|P1|Participant Flow|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475173|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475174|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475175|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475176|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475177|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475178|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475179|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475180|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475181|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475182|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475183|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475184|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475185|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475186|NCT00811018|E1|Reported Event|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
475187|NCT00810901|B3|Baseline|Total|Total of all reporting groups
475188|NCT00810901|B2|Baseline|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
475189|NCT00810901|B1|Baseline|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
475190|NCT00810901|P2|Participant Flow|Alcohol Prevention|"Intervention used a digital video disk (DVD) and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
475191|NCT00810901|P1|Participant Flow|Organ Donor|"Intervention used a digital video disk (DVD), text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
475192|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
475347|NCT00810511|P1|Participant Flow|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
475348|NCT00810511|O2|Outcome|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
475193|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
475194|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
475195|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
475196|NCT00810901|E2|Reported Event|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
475197|NCT00810901|E1|Reported Event|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
475198|NCT00810888|B4|Baseline|Total|Total of all reporting groups
475199|NCT00810888|B3|Baseline|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475200|NCT00810888|B2|Baseline|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475201|NCT00810888|B1|Baseline|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475202|NCT00810888|P3|Participant Flow|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475203|NCT00810888|P2|Participant Flow|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475204|NCT00810888|P1|Participant Flow|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475205|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475206|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475207|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475208|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475209|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475210|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475211|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475349|NCT00810511|O1|Outcome|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
478542|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
475212|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475213|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475214|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475215|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475216|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475217|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475218|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475219|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475220|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475221|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475222|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475223|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475224|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475225|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475226|NCT00810888|O3|Outcome|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475227|NCT00810888|O2|Outcome|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475228|NCT00810888|O1|Outcome|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475350|NCT00810511|E2|Reported Event|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
475229|NCT00810888|E3|Reported Event|Group 3 - Observation Only Arm|Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
475230|NCT00810888|E2|Reported Event|Group 2 - Randomized to Placebo|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).~Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)"
475231|NCT00810888|E1|Reported Event|Group 1 - Randomized to Study Drug|"Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA spot sign positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .~Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)."
475232|NCT00810810|B5|Baseline|Total|Total of all reporting groups
475233|NCT00810810|B4|Baseline|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475234|NCT00810810|B3|Baseline|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475235|NCT00810810|B2|Baseline|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475236|NCT00810810|B1|Baseline|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
475237|NCT00810810|P4|Participant Flow|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475238|NCT00810810|P3|Participant Flow|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475239|NCT00810810|P2|Participant Flow|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475240|NCT00810810|P1|Participant Flow|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
475241|NCT00810810|O4|Outcome|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475242|NCT00810810|O3|Outcome|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475243|NCT00810810|O2|Outcome|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475244|NCT00810810|O1|Outcome|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
475245|NCT00810810|O4|Outcome|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475246|NCT00810810|O3|Outcome|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475247|NCT00810810|O2|Outcome|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475248|NCT00810810|O1|Outcome|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
475249|NCT00810810|E4|Reported Event|3. Leukoreduced Gamma Irradiated|Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475250|NCT00810810|E3|Reported Event|2. Leukoreduced|Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475251|NCT00810810|E2|Reported Event|1. Standard|Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
475252|NCT00810810|E1|Reported Event|4. No Transfusion|This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
475253|NCT00810771|B4|Baseline|Total|Total of all reporting groups
475287|NCT00810693|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475254|NCT00810771|B3|Baseline|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
475255|NCT00810771|B2|Baseline|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
475256|NCT00810771|B1|Baseline|Preference-tailored (PT) Intervention|Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
475257|NCT00810771|P3|Participant Flow|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
475258|NCT00810771|P2|Participant Flow|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
475259|NCT00810771|P1|Participant Flow|Preference-tailored (PT) Intervention|"Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.~Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
475260|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
475261|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
475262|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
475263|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
475264|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
475265|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
475266|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
475267|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
475268|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
475269|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
475270|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
475271|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
475272|NCT00810771|O3|Outcome|Usual Care|"Usual Care - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening."
475288|NCT00810693|P3|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475273|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
475274|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
475275|NCT00810771|E3|Reported Event|Usual Care|"Usual Care - due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm."
475276|NCT00810771|E2|Reported Event|Standard Information (SI) Intervention|Standard information (SI) intervention
475277|NCT00810771|E1|Reported Event|Preference-tailored (PT) Intervention|Preference-tailored (PT) intervention
475278|NCT00810719|B1|Baseline|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
475279|NCT00810719|P1|Participant Flow|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
475280|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
475281|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
475282|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
475283|NCT00810719|E1|Reported Event|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
475284|NCT00810693|B4|Baseline|Total|Total of all reporting groups
475285|NCT00810693|B3|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475286|NCT00810693|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475321|NCT00810641|B1|Baseline|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
475322|NCT00810641|P3|Participant Flow|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
475289|NCT00810693|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475290|NCT00810693|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475291|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475292|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475293|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475294|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475295|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475296|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475297|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475298|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475299|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475300|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475301|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475302|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475303|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475304|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475305|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475306|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475307|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475308|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475309|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475310|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475311|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475312|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475313|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475314|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475315|NCT00810693|E3|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
475316|NCT00810693|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475317|NCT00810693|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
475318|NCT00810641|B4|Baseline|Total|Total of all reporting groups
475319|NCT00810641|B3|Baseline|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
475320|NCT00810641|B2|Baseline|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
475331|NCT00810602|B1|Baseline|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
475332|NCT00810602|P2|Participant Flow|Phase 2|100 mg was selected as the Phase 2 dose. Participants were administered Vorinostat, 100 mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
475333|NCT00810602|P1|Participant Flow|Phase 1|In the Phase 1 portion of the study, participants were administered Vorinostat, either 100 mg or 200mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
475334|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
475335|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
475336|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
475337|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
475338|NCT00810602|E1|Reported Event|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
475339|NCT00810576|B1|Baseline|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
475340|NCT00810576|P1|Participant Flow|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
475341|NCT00810576|O1|Outcome|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
475342|NCT00810576|E1|Reported Event|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
475343|NCT00810511|B3|Baseline|Total|Total of all reporting groups
475344|NCT00810511|B2|Baseline|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
475345|NCT00810511|B1|Baseline|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
475346|NCT00810511|P2|Participant Flow|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
475351|NCT00810511|E1|Reported Event|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
475352|NCT00810394|B1|Baseline|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
475353|NCT00810394|P1|Participant Flow|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
475354|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
475355|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
475356|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
475357|NCT00810394|E1|Reported Event|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
475358|NCT00810368|B3|Baseline|Total|Total of all reporting groups
475359|NCT00810368|B2|Baseline|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475360|NCT00810368|B1|Baseline|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475361|NCT00810368|P2|Participant Flow|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475362|NCT00810368|P1|Participant Flow|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475363|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475364|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475365|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475366|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475367|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475368|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475369|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475370|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475371|NCT00810368|O2|Outcome|Placebo Control Group|"Placebo control group~Placebo: Microcrystalline cellulose placebo tablets x2 daily"
475372|NCT00810368|O1|Outcome|Carnosine Treatment Group|"Carnosine treatment group~Carnosine: 500mg Carnosine x2 daily"
475373|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475374|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475536|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
475375|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475376|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475377|NCT00810368|E2|Reported Event|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
475378|NCT00810368|E1|Reported Event|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
475379|NCT00810355|B4|Baseline|Total|Total of all reporting groups
475380|NCT00810355|B3|Baseline|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
475381|NCT00810355|B2|Baseline|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
475382|NCT00810355|B1|Baseline|Support Group|"Support group~Support Group: General support and problem solving for work activity"
475383|NCT00810355|P3|Participant Flow|Cognitive Behavior Therapy and Cognitive Remediation|"Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
475384|NCT00810355|P2|Participant Flow|Cognitive Behavior Therapy|Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
475385|NCT00810355|P1|Participant Flow|Support Group|Support Group: General support and problem solving for work activity
475386|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
475387|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
475388|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
475389|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
475390|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
475391|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
475392|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
475393|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
475394|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
475395|NCT00810355|E3|Reported Event|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
475396|NCT00810355|E2|Reported Event|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
475397|NCT00810355|E1|Reported Event|Support Group|"Support group~Support Group: General support and problem solving for work activity"
475398|NCT00810342|B3|Baseline|Total|Total of all reporting groups
475399|NCT00810342|B2|Baseline|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
475400|NCT00810342|B1|Baseline|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
475401|NCT00810342|P2|Participant Flow|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
475402|NCT00810342|P1|Participant Flow|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
478543|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
475403|NCT00810342|O2|Outcome|2 - Physical Activity Standard|"Standard Website resources / information on physical activity~physical activity standard: standard print and website information on how to become more active"
475404|NCT00810342|O1|Outcome|1- Physical Activity Tailored|"Tailored telephone counseling about how to become more physically active and goal setting. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
475405|NCT00810342|O2|Outcome|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
475406|NCT00810342|O1|Outcome|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
475407|NCT00810342|E2|Reported Event|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
475408|NCT00810342|E1|Reported Event|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
475409|NCT00810303|B1|Baseline|Study Group|whole study group: 12 healthy subjects
475410|NCT00810303|P1|Participant Flow|Study Group|whole study group: 12 healthy subjects
475411|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475412|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475413|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475414|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475415|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475416|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475417|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475418|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475419|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475420|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475421|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475422|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475423|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475424|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475425|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475426|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475427|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475428|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
475429|NCT00810303|E5|Reported Event|Ezetimibe and Efavirenz Multiple Dose|
475430|NCT00810303|E4|Reported Event|Ezetimibe Multiple Dose and Efavirenz Single Dose|
475431|NCT00810303|E3|Reported Event|Ezetimibe Alone Multiple Dose|
475432|NCT00810303|E2|Reported Event|Efavirenz Alone Single Dose|
475433|NCT00810303|E1|Reported Event|Study Group|whole study group: 12 healthy subjects
475434|NCT00810277|B1|Baseline|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475435|NCT00810277|P1|Participant Flow|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475436|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475437|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475438|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475439|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475440|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475441|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475442|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475443|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475444|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475445|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475446|NCT00810277|E1|Reported Event|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
475447|NCT00810199|B3|Baseline|Total|Total of all reporting groups
475537|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
475538|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
475539|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
475540|NCT00810095|E1|Reported Event|Treatment Group|All participants treated with the Test System
475541|NCT00810082|B3|Baseline|Total|Total of all reporting groups
475631|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475448|NCT00810199|B2|Baseline|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475449|NCT00810199|B1|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475450|NCT00810199|P2|Participant Flow|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475451|NCT00810199|P1|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475452|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475453|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475454|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475455|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475542|NCT00810082|B2|Baseline|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
475632|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
475456|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475457|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475458|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475459|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475460|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added
475461|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
475462|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
475463|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
475464|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475465|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475466|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475467|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475468|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475469|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475470|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475471|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475472|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475473|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475474|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475543|NCT00810082|B1|Baseline|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
475578|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475475|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475476|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475477|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475478|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475479|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475480|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475481|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475482|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475544|NCT00810082|P2|Participant Flow|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
478544|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
475483|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475484|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475485|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475486|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475487|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475488|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475489|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475490|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475545|NCT00810082|P1|Participant Flow|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
475579|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475633|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475634|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475491|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475492|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475493|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475494|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475495|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475496|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475497|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475498|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475546|NCT00810082|O2|Outcome|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
475635|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
475499|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475500|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475501|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475502|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
475503|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
475504|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
475505|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
475506|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475507|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475508|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475509|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475510|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475511|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475512|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475513|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475514|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475515|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475516|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475517|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475547|NCT00810082|O1|Outcome|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
475580|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475518|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475519|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475520|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475521|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475522|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
475523|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
475524|NCT00810199|E2|Reported Event|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
475525|NCT00810199|E1|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
475526|NCT00810108|B3|Baseline|Total|Total of all reporting groups
475527|NCT00810108|B2|Baseline|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
475528|NCT00810108|B1|Baseline|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
475529|NCT00810108|P2|Participant Flow|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
475530|NCT00810108|P1|Participant Flow|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
475531|NCT00810108|O2|Outcome|All Subjects Taking Crushed Tablets|Lopinavir AUC from all subjects taking the crushed tablet
475532|NCT00810108|O1|Outcome|All Subjects Taking Whole Tablets|Lopinavir AUC from all subjects taking the whole tablet
475533|NCT00810108|E1|Reported Event|All Subjects|Data from all subjects combined
475534|NCT00810095|B1|Baseline|Treatment Group|All participants treated with the Test System
475535|NCT00810095|P1|Participant Flow|MindFrame System Treatment Group|All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset.
475548|NCT00810082|E2|Reported Event|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
475549|NCT00810082|E1|Reported Event|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
475550|NCT00810069|B3|Baseline|Total|Total of all reporting groups
475551|NCT00810069|B2|Baseline|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475552|NCT00810069|B1|Baseline|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475553|NCT00810069|P3|Participant Flow|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475554|NCT00810069|P2|Participant Flow|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475555|NCT00810069|P1|Participant Flow|Escitalopram (Acute Treatment)|Escitalopram 10 milligrams (mg) per day for 4 weeks
475556|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475557|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475558|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475559|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475560|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475561|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475562|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475563|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475564|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475565|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475566|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475567|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475568|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475569|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475570|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475571|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475572|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475573|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475574|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475575|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475576|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475577|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475581|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475582|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475583|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475584|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475585|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475586|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475587|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475588|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475589|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475590|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
475591|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
475592|NCT00810069|E5|Reported Event|Delayed Intervention Non-Responders|Duloxetine 60 or 120 mg per day for 8 weeks.
475593|NCT00810069|E4|Reported Event|Delayed Intervention Responders|Escitalopram 10 to 20 mg per day for 8 weeks.
475594|NCT00810069|E3|Reported Event|Early Intervention (Double Blind)|Duloxetine flexible dose (60 or 120 milligram [mg] daily) for 12 weeks.
475595|NCT00810069|E2|Reported Event|Delayed Intervention (Double Blind)|Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule[s]). Then, non-responders switched to duloxetine 60 or 120 mg per day for 8 weeks, and responders continued on escitalopram 10 to 20 mg per day for 8 weeks.
475596|NCT00810069|E1|Reported Event|Escitalopram (Acute Treatment)|Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule)
475597|NCT00810043|B3|Baseline|Total|Total of all reporting groups
475598|NCT00810043|B2|Baseline|IBT-First|Use of the inflatable bone tamps prior to using the curette
475599|NCT00810043|B1|Baseline|Curette-First|Use of the curette prior to use of the inflatable bone tamps
475600|NCT00810043|P3|Participant Flow|Non-treated Patients|Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
475601|NCT00810043|P2|Participant Flow|IBT-First|Use of the inflatable bone tamps prior to using the curette
475602|NCT00810043|P1|Participant Flow|Curette-First|Use of the curette prior to use of the inflatable bone tamps
475603|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
475604|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
475605|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
475606|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
475607|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
475608|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
475609|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
475610|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
475611|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
475612|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
475613|NCT00810043|O1|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
475614|NCT00810043|O2|Outcome|IBT-First|Use of the inflatable bone tamps prior to using the curette
475615|NCT00810043|O1|Outcome|Curette-First|Use of the curette prior to use of the inflatable bone tamps
475616|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
475617|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
475618|NCT00810043|E2|Reported Event|IBT-First|Use of the inflatable bone tamps prior to using the curette
475619|NCT00810043|E1|Reported Event|Curette-First|Use of the curette prior to use of the inflatable bone tamps
475620|NCT00809965|B4|Baseline|Total|Total of all reporting groups
475621|NCT00809965|B3|Baseline|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475622|NCT00809965|B2|Baseline|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475623|NCT00809965|B1|Baseline|Placebo|One placebo tablet twice daily
475624|NCT00809965|P3|Participant Flow|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475625|NCT00809965|P2|Participant Flow|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475626|NCT00809965|P1|Participant Flow|Placebo|One placebo tablet twice daily
475627|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475628|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475636|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475637|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475638|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
475639|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475640|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475641|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
475642|NCT00809965|E3|Reported Event|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
475643|NCT00809965|E2|Reported Event|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
475644|NCT00809965|E1|Reported Event|Placebo|One placebo tablet twice daily
475645|NCT00809926|B3|Baseline|Total|Total of all reporting groups
475646|NCT00809926|B2|Baseline|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475647|NCT00809926|B1|Baseline|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475648|NCT00809926|P2|Participant Flow|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475649|NCT00809926|P1|Participant Flow|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475650|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475651|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475652|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475653|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475654|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475655|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475656|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475657|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475658|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475659|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475660|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475661|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475662|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475663|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475664|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475665|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475666|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475667|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475668|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
475669|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
475670|NCT00809926|E2|Reported Event|Valsartan|Valsartan (160mg) for 2weeks followed by forced titration toValsartan (320mg) for the remaining 6 weeks
475671|NCT00809926|E1|Reported Event|Valsartan/ Aliskiren|Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
475672|NCT00809848|B6|Baseline|Total|Total of all reporting groups
475673|NCT00809848|B5|Baseline|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
475674|NCT00809848|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
475675|NCT00809848|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
475676|NCT00809848|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
475677|NCT00809848|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
475678|NCT00809848|P5|Participant Flow|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
475679|NCT00809848|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
475680|NCT00809848|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
475681|NCT00809848|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
475682|NCT00809848|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
475683|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
475684|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
475685|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
475686|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
475687|NCT00809848|O1|Outcome|AGN 210669 Non-preserved Ophthalmic Solution, 0.075%|AGN 210669 non-preserved ophthalmic solution, 0.075%. One drop in each eye each morning once-daily for 2 weeks.
475688|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
475689|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
475690|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
475691|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
475692|NCT00809848|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
475693|NCT00809848|E5|Reported Event|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
475694|NCT00809848|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
475695|NCT00809848|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
475696|NCT00809848|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
475697|NCT00809848|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
475698|NCT00809835|B5|Baseline|Total|Total of all reporting groups
475699|NCT00809835|B4|Baseline|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
475700|NCT00809835|B3|Baseline|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
475701|NCT00809835|B2|Baseline|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
475702|NCT00809835|B1|Baseline|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
475703|NCT00809835|P4|Participant Flow|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
475704|NCT00809835|P3|Participant Flow|Placebo and CBT|TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
475705|NCT00809835|P2|Participant Flow|Galantamine Only|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
475706|NCT00809835|P1|Participant Flow|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
475734|NCT00809757|B2|Baseline|Levalbuterol MDI|Levalbuterol MDI TID
475707|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
475708|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
475709|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
475710|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
475711|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
475712|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
475713|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
475714|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
475715|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
475716|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
475717|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
475718|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
475719|NCT00809835|E4|Reported Event|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
475720|NCT00809835|E3|Reported Event|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
475721|NCT00809835|E2|Reported Event|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
475722|NCT00809835|E1|Reported Event|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
475723|NCT00809809|B3|Baseline|Total|Total of all reporting groups
475724|NCT00809809|B2|Baseline|Placebo Treatment|Placebo medication - Swabs identical to medication group
475725|NCT00809809|B1|Baseline|Active Treatment|Active medication - Zinc Swabs
475726|NCT00809809|P2|Participant Flow|Placebo Treatment|Placebo medication - Swabs identical to medication group
475727|NCT00809809|P1|Participant Flow|Active Treatment|Active medication - Zinc Swabs
475728|NCT00809809|O2|Outcome|Placebo Treatment|Placebo medication - Swabs identical to medication group
475729|NCT00809809|O1|Outcome|Active Treatment|Active medication - Zinc Swabs
475730|NCT00809809|E2|Reported Event|Placebo Treatment|Placebo medication - Swabs identical to medication group
475731|NCT00809809|E1|Reported Event|Active Treatment|Active medication - Zinc Swabs
475732|NCT00809757|B4|Baseline|Total|Total of all reporting groups
475733|NCT00809757|B3|Baseline|Levalbuterol UDV|Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475736|NCT00809757|P3|Participant Flow|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
475737|NCT00809757|P2|Participant Flow|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
475738|NCT00809757|P1|Participant Flow|Placebo|Placebo: Placebo (2 actuations)
475739|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475740|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475741|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475742|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475743|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475744|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475745|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475746|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475747|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475748|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475749|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475750|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475751|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475752|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475753|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475754|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475755|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475756|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475757|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475758|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475759|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
475760|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475761|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475762|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475763|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475764|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475765|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475766|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475767|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475768|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
475769|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475770|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475771|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475772|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475773|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475774|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475775|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475776|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475777|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475778|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475779|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475780|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475781|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475782|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475783|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475784|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475785|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475786|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475787|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475788|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475789|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475790|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475791|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475792|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475793|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475794|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475795|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475796|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475797|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475798|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475799|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
475800|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475801|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
475802|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475803|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475804|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
475805|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
475806|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475807|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475808|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
475809|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475810|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475811|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475812|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475813|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
475814|NCT00809757|O3|Outcome|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
475815|NCT00809757|O2|Outcome|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
475816|NCT00809757|O1|Outcome|Placebo|Placebo: Placebo (2 actuations)
475817|NCT00809757|E3|Reported Event|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
475818|NCT00809757|E2|Reported Event|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
475819|NCT00809757|E1|Reported Event|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
475820|NCT00809614|B3|Baseline|Total|Total of all reporting groups
475821|NCT00809614|B2|Baseline|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475822|NCT00809614|B1|Baseline|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475823|NCT00809614|P2|Participant Flow|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475824|NCT00809614|P1|Participant Flow|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475825|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475826|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475827|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475828|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475829|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475830|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475831|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475832|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475833|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475834|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475835|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475836|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475837|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475838|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475839|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475840|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475841|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475842|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475843|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475844|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475845|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475846|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475847|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475848|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475849|NCT00809614|E2|Reported Event|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
475850|NCT00809614|E1|Reported Event|AIN457 2x10mg/kg|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
475851|NCT00809523|B3|Baseline|Total|Total of all reporting groups
475852|NCT00809523|B2|Baseline|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
475853|NCT00809523|B1|Baseline|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
475854|NCT00809523|P2|Participant Flow|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
475855|NCT00809523|P1|Participant Flow|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
475856|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
475857|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
475858|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
475859|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
475860|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
475861|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
475862|NCT00809523|E2|Reported Event|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
475863|NCT00809523|E1|Reported Event|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
475864|NCT00809471|B4|Baseline|Total|Total of all reporting groups
475865|NCT00809471|B3|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
475866|NCT00809471|B2|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
475867|NCT00809471|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
475868|NCT00809471|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
475869|NCT00809471|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
475870|NCT00809471|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
475871|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
475872|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
475873|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
475874|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
475875|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
475876|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
475877|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
475878|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
475879|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
475880|NCT00809471|E3|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
475881|NCT00809471|E2|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
475882|NCT00809471|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
475883|NCT00809458|B3|Baseline|Total|Total of all reporting groups
475884|NCT00809458|B2|Baseline|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
475885|NCT00809458|B1|Baseline|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
475886|NCT00809458|P2|Participant Flow|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
475887|NCT00809458|P1|Participant Flow|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
475888|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
475889|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
475890|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
475891|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
475892|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
475893|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
475894|NCT00809458|E2|Reported Event|Arm 2|"Placebo (same vehicle as used for vitamin E)~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
475895|NCT00809458|E1|Reported Event|Arm 1 (Vitamin E)|"Vitamin E~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
475896|NCT00809445|B4|Baseline|Total|Total of all reporting groups
475897|NCT00809445|B3|Baseline|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
475898|NCT00809445|B2|Baseline|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
475899|NCT00809445|B1|Baseline|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
475900|NCT00809445|P3|Participant Flow|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
475901|NCT00809445|P2|Participant Flow|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
475902|NCT00809445|P1|Participant Flow|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
475903|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
475904|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
475905|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
475906|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
475907|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
475908|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
475909|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
475910|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
475911|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
475912|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
475913|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
475914|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
475915|NCT00809445|E3|Reported Event|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
475916|NCT00809445|E2|Reported Event|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
475917|NCT00809445|E1|Reported Event|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
475918|NCT00809328|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475919|NCT00809328|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475920|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475921|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475922|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475923|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475924|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475925|NCT00809328|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
475926|NCT00809276|B1|Baseline|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
475927|NCT00809276|P1|Participant Flow|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
475928|NCT00809276|O1|Outcome|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
475929|NCT00809276|E1|Reported Event|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
475930|NCT00809185|B1|Baseline|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
475931|NCT00809185|P1|Participant Flow|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
475932|NCT00809185|O1|Outcome|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
476864|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
475933|NCT00809185|E1|Reported Event|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
475934|NCT00809159|B5|Baseline|Total|Total of all reporting groups
475935|NCT00809159|B4|Baseline|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475936|NCT00809159|B3|Baseline|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475937|NCT00809159|B2|Baseline|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475938|NCT00809159|B1|Baseline|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475939|NCT00809159|P6|Participant Flow|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475940|NCT00809159|P5|Participant Flow|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475941|NCT00809159|P4|Participant Flow|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475942|NCT00809159|P3|Participant Flow|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475943|NCT00809159|P2|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475944|NCT00809159|P1|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475945|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475946|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475947|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475948|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475949|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475950|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475951|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475952|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475953|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475954|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475955|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475956|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475957|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475958|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475959|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/Kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475960|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475961|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475962|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475963|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475964|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475965|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475966|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475967|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475968|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475969|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475970|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475971|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475972|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475973|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475974|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475975|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475976|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475977|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475978|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475979|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475980|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475981|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475982|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475983|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475984|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475985|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475986|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475987|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475988|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475989|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475990|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475991|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475992|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475993|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475994|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
475995|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475996|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
475997|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
475998|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
475999|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
476000|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
476001|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
476002|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
476003|NCT00809159|E4|Reported Event|Placebo|Placebo to AIN457A was administered intravenously as a single dose
476004|NCT00809159|E3|Reported Event|AIN457 2x0.1mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
476005|NCT00809159|E2|Reported Event|AIN457 2x1.0mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
476006|NCT00809159|E1|Reported Event|AIN457 2x10mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
476007|NCT00809146|B3|Baseline|Total|Total of all reporting groups
476008|NCT00809146|B2|Baseline|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
476009|NCT00809146|B1|Baseline|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
476010|NCT00809146|P2|Participant Flow|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
476046|NCT00809133|B3|Baseline|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476011|NCT00809146|P1|Participant Flow|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
476012|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476013|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476014|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476015|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476016|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476017|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476018|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476019|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476020|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476021|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476022|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476023|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476024|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476025|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476026|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476027|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476028|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476029|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476030|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476031|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476032|NCT00809146|E2|Reported Event|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
476033|NCT00809146|E1|Reported Event|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
476034|NCT00809133|B15|Baseline|Total|Total of all reporting groups
476035|NCT00809133|B14|Baseline|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476036|NCT00809133|B13|Baseline|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476037|NCT00809133|B12|Baseline|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476038|NCT00809133|B11|Baseline|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476039|NCT00809133|B10|Baseline|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476040|NCT00809133|B9|Baseline|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476041|NCT00809133|B8|Baseline|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476042|NCT00809133|B7|Baseline|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476043|NCT00809133|B6|Baseline|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476044|NCT00809133|B5|Baseline|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476045|NCT00809133|B4|Baseline|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476865|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
476047|NCT00809133|B2|Baseline|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476048|NCT00809133|B1|Baseline|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476049|NCT00809133|P14|Participant Flow|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476050|NCT00809133|P13|Participant Flow|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476051|NCT00809133|P12|Participant Flow|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476052|NCT00809133|P11|Participant Flow|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476053|NCT00809133|P10|Participant Flow|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476054|NCT00809133|P9|Participant Flow|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476055|NCT00809133|P8|Participant Flow|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476056|NCT00809133|P7|Participant Flow|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476057|NCT00809133|P6|Participant Flow|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476058|NCT00809133|P5|Participant Flow|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476059|NCT00809133|P4|Participant Flow|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476060|NCT00809133|P3|Participant Flow|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476061|NCT00809133|P2|Participant Flow|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476062|NCT00809133|P1|Participant Flow|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476063|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476064|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476065|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476066|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476067|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476068|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476182|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476069|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476070|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476071|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476072|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476073|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476074|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476075|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476076|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476077|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476078|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476079|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476080|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476081|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476082|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476083|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476084|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476085|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476086|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476087|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476088|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476089|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476090|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476091|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476092|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476093|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476094|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476095|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476096|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476097|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476098|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476099|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476100|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476101|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476102|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476103|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476104|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476105|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476106|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476107|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476108|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476109|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476110|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476111|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476112|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476113|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476183|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476114|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476115|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476116|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476117|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476118|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476119|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476120|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476121|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476122|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476123|NCT00809133|O2|Outcome|Part B: End of 2nd Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
476124|NCT00809133|O1|Outcome|Part B: End of 1st Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
476125|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476126|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476127|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476128|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476129|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476130|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476131|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476132|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476133|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476134|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476135|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476866|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
476136|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476137|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476138|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476139|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476140|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476141|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476142|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476143|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476144|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476145|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476146|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476147|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476148|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476149|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476150|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476151|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476152|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476153|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476154|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476155|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476156|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476157|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476158|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476159|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476867|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
476160|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476161|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476162|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476163|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476164|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476165|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476166|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476167|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476168|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476169|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476170|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476171|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476172|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476173|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476174|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476175|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476176|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476177|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476178|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476179|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476180|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476181|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476868|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
476184|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476185|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476186|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476187|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476188|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476189|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476190|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476191|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476192|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476193|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476194|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476195|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476196|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476197|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476198|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476199|NCT00809133|E14|Reported Event|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476200|NCT00809133|E13|Reported Event|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476201|NCT00809133|E12|Reported Event|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476202|NCT00809133|E11|Reported Event|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
476203|NCT00809133|E10|Reported Event|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476204|NCT00809133|E9|Reported Event|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
476205|NCT00809133|E8|Reported Event|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476297|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476206|NCT00809133|E7|Reported Event|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476207|NCT00809133|E6|Reported Event|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476208|NCT00809133|E5|Reported Event|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476209|NCT00809133|E4|Reported Event|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
476210|NCT00809133|E3|Reported Event|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476211|NCT00809133|E2|Reported Event|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476212|NCT00809133|E1|Reported Event|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
476213|NCT00809094|B3|Baseline|Total|Total of all reporting groups
476214|NCT00809094|B2|Baseline|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476215|NCT00809094|B1|Baseline|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476216|NCT00809094|P2|Participant Flow|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476217|NCT00809094|P1|Participant Flow|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476218|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476219|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476220|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476221|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476222|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476223|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476224|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476225|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476226|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476227|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476228|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476229|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476230|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476231|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476232|NCT00809094|E2|Reported Event|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
476233|NCT00809094|E1|Reported Event|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
476234|NCT00809055|B3|Baseline|Total|Total of all reporting groups
476235|NCT00809055|B2|Baseline|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476236|NCT00809055|B1|Baseline|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476869|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
476237|NCT00809055|P2|Participant Flow|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476238|NCT00809055|P1|Participant Flow|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476239|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476240|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476241|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476242|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476243|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476244|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476245|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476246|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476247|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476248|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476249|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476250|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476251|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476252|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476253|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476254|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476255|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476256|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476257|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476870|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
476258|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476259|NCT00809055|E2|Reported Event|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476260|NCT00809055|E1|Reported Event|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
476261|NCT00808899|B1|Baseline|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
476262|NCT00808899|P1|Participant Flow|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
476263|NCT00808899|O1|Outcome|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
476264|NCT00808899|E1|Reported Event|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
476265|NCT00808834|B1|Baseline|Overall|This reporting group includes all enrolled and exposed subjects.
476266|NCT00808834|P2|Participant Flow|Lotrafilcon A / Senofilcon A|Lotrafilcon A, followed by Senofilcon A
476267|NCT00808834|P1|Participant Flow|Senofilcon A / Lotrafilcon A|Senofilcon A, followed by Lotrafilcon A
476268|NCT00808834|O2|Outcome|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
476269|NCT00808834|O1|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
476270|NCT00808834|E2|Reported Event|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
476271|NCT00808834|E1|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
476272|NCT00808808|B4|Baseline|Total|Total of all reporting groups
476273|NCT00808808|B3|Baseline|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476274|NCT00808808|B2|Baseline|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476275|NCT00808808|B1|Baseline|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476276|NCT00808808|P3|Participant Flow|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476277|NCT00808808|P2|Participant Flow|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476278|NCT00808808|P1|Participant Flow|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476279|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as male.
476280|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as male.
476281|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as college graduates.
476282|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as college graduates.
476283|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as white.
476284|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as white
476285|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476286|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476287|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476288|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476289|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476290|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476291|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476292|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476293|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476294|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476295|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476296|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476298|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476299|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476300|NCT00808808|E3|Reported Event|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
476301|NCT00808808|E2|Reported Event|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
476302|NCT00808808|E1|Reported Event|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
476303|NCT00808769|B1|Baseline|All Study Participants|
476304|NCT00808769|P2|Participant Flow|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
476305|NCT00808769|P1|Participant Flow|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
476306|NCT00808769|O2|Outcome|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
476307|NCT00808769|O1|Outcome|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
476308|NCT00808769|E2|Reported Event|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
476309|NCT00808769|E1|Reported Event|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
476310|NCT00808665|B3|Baseline|Total|Total of all reporting groups
476311|NCT00808665|B2|Baseline|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476312|NCT00808665|B1|Baseline|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476313|NCT00808665|P2|Participant Flow|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476314|NCT00808665|P1|Participant Flow|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476315|NCT00808665|O2|Outcome|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476316|NCT00808665|O1|Outcome|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476335|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476517|NCT00808340|P4|Participant Flow|Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, balafilcon A worn second, and senofilcon A test worn third.
476317|NCT00808665|E2|Reported Event|Saline|"Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476318|NCT00808665|E1|Reported Event|Dexmedetomidine|"At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.~Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump."
476319|NCT00808639|B1|Baseline|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
476320|NCT00808639|P1|Participant Flow|Dose Dense MVAC|Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)
476321|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
476322|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
476323|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
476324|NCT00808639|E1|Reported Event|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
476325|NCT00808509|B3|Baseline|Total|Total of all reporting groups
476326|NCT00808509|B2|Baseline|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476327|NCT00808509|B1|Baseline|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476328|NCT00808509|P2|Participant Flow|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476329|NCT00808509|P1|Participant Flow|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476330|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476331|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476332|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476333|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476334|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476442|NCT00808483|O1|Outcome|Walking Skill Training Group|12 session of participation in the supervised walking skill training program
476336|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476337|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476338|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476339|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476340|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476341|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476342|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476343|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476344|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476345|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476346|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476347|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476348|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476349|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476350|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476351|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476352|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476353|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476354|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476443|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
476355|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476356|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476357|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476358|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476359|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476360|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476361|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476362|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476363|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476364|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476365|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476366|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476367|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476368|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476369|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476370|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476371|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476372|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476373|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476511|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
476512|NCT00808405|E2|Reported Event|Placebo|Matching placebo tablet
476374|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476375|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476376|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476377|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476378|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476379|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476380|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476381|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476382|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476383|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476384|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476385|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476386|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476387|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476388|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476389|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476390|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476391|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476392|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476513|NCT00808405|E1|Reported Event|Acyclovir|Acyclovir 400 mg orally three times daily
476393|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476394|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476395|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476396|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476397|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476398|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476399|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476400|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476401|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476402|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476403|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476404|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476405|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476406|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476407|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476408|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476409|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476410|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476411|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476514|NCT00808340|B1|Baseline|Overall|
476855|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
476412|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476413|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476414|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476415|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476416|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476417|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476418|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476419|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476420|NCT00808509|E4|Reported Event|Methotrexate-Including Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476421|NCT00808509|E3|Reported Event|Methotrexate-Rescue Arm|Participants received methotrexate alone for 52 weeks, but due to an increase in disease activity were reinstituted with adalimumab 40 mg subcutaneously every other week during the 52-week randomized period. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476422|NCT00808509|E2|Reported Event|Methotrexate-Excluding Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks and were not reinstituted to adalimumab as rescue treatment. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476423|NCT00808509|E1|Reported Event|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
476424|NCT00808483|B3|Baseline|Total|Total of all reporting groups
476425|NCT00808483|B2|Baseline|Control Group|No participation in the walking skill training group
476426|NCT00808483|B1|Baseline|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and sit-to-stand with guidance and supervision from a physiotherapist."
476427|NCT00808483|P2|Participant Flow|Control Group|No participation in the walking skill training group
476428|NCT00808483|P1|Participant Flow|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
476429|NCT00808483|O2|Outcome|Control Group|No session of participation in the walking skill training program
476430|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
476431|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
476432|NCT00808483|O1|Outcome|Walking Skilll Training Group|12 sessions of participation in the supervised walking skilll training program
476433|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
476434|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
476435|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
476436|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
476437|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
476438|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training group
476439|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
476440|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in a supervised walking skill training program
476441|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
476856|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
476444|NCT00808483|O1|Outcome|Walking Skill Training Group|"12 sessions of participation in the supervised walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
476445|NCT00808483|E2|Reported Event|Control Group|No participation in the walking skill training group
476446|NCT00808483|E1|Reported Event|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
476447|NCT00808470|B3|Baseline|Total|Total of all reporting groups
476448|NCT00808470|B2|Baseline|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
476449|NCT00808470|B1|Baseline|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
476450|NCT00808470|P2|Participant Flow|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
476451|NCT00808470|P1|Participant Flow|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
476452|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
476453|NCT00808470|O1|Outcome|Nutrients|"beta-carotene, vitamins C and E, magnesium~beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
476454|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
476455|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
476456|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
476457|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
476458|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
476459|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
476460|NCT00808470|E2|Reported Event|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
476515|NCT00808340|P6|Participant Flow|Balafilcon A/Senofilcon A Prod/Senofilcon A Test|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A producton worn second, senofilcon A test worn third.
476857|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
476461|NCT00808470|E1|Reported Event|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
476462|NCT00808444|B3|Baseline|Total|Total of all reporting groups
476463|NCT00808444|B2|Baseline|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476464|NCT00808444|B1|Baseline|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476465|NCT00808444|P2|Participant Flow|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476466|NCT00808444|P1|Participant Flow|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476467|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476468|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476469|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476470|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476471|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476472|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476473|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476474|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476475|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476858|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
476476|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476477|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476478|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476479|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476480|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476481|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476482|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476483|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476484|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476485|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476486|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476487|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476488|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476489|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476516|NCT00808340|P5|Participant Flow|Balafilcon A/Senofilcon A Test/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
476490|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476491|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476492|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476493|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476494|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476495|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476496|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476497|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476498|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476499|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476500|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476501|NCT00808444|E2|Reported Event|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476502|NCT00808444|E1|Reported Event|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
476503|NCT00808405|B3|Baseline|Total|Total of all reporting groups
476504|NCT00808405|B2|Baseline|Placebo|Matching placebo tablet
476505|NCT00808405|B1|Baseline|Acyclovir|Acyclovir 400 mg orally three times daily
476506|NCT00808405|P2|Participant Flow|Placebo|Matching placebo tablet
476507|NCT00808405|P1|Participant Flow|Acyclovir|Acyclovir 400 mg orally three times daily
476508|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
476509|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
476510|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
476518|NCT00808340|P3|Participant Flow|Senofilcon A Prod/Senofilcon A Test/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, senofilcon A test worn second, and balafilcon A worn third.
476519|NCT00808340|P2|Participant Flow|Senofilcon A Test/Balafilcon A/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
476520|NCT00808340|P1|Participant Flow|Senofilcon A Test/Senofilcon A Prod/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
476521|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
476522|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
476523|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
476524|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
476525|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
476526|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
476527|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
476528|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
476529|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
476530|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
476531|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
476532|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
476533|NCT00808340|E3|Reported Event|Balafilcon A|
476534|NCT00808340|E2|Reported Event|Senofilcon A Prod|
476535|NCT00808340|E1|Reported Event|Senofilcon A Test|
476536|NCT00808249|B5|Baseline|Total|Total of all reporting groups
476537|NCT00808249|B4|Baseline|D-Placebo|Placebo
476538|NCT00808249|B3|Baseline|C-AZD7325 10 mg|AZD7325 10 mg QD
476539|NCT00808249|B2|Baseline|B-AZD7325 5 mg|AZD7325 5 mg BID
476540|NCT00808249|B1|Baseline|A-AZD7325 2 mg|AZD7325 2 mg BID
476541|NCT00808249|P4|Participant Flow|D-Placebo|Placebo
476542|NCT00808249|P3|Participant Flow|C-AZD7325 10 mg|AZD7325 10 mg QD
476543|NCT00808249|P2|Participant Flow|B-AZD7325 5 mg|AZD7325 5 mg BID
476544|NCT00808249|P1|Participant Flow|A-AZD7325 2 mg|AZD7325 2 mg BID
476545|NCT00808249|O4|Outcome|D-Placebo|Placebo
476546|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
476547|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
476548|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
476549|NCT00808249|O4|Outcome|D-Placebo|Placebo
476550|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
476551|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
476552|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
476553|NCT00808249|O4|Outcome|D-Placebo|Placebo
476554|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
476555|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
476556|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
476557|NCT00808249|O4|Outcome|D-Placebo|Placebo
476558|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
476559|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
476560|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
476561|NCT00808249|O4|Outcome|D-Placebo|Placebo
476562|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
476563|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
476564|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
476565|NCT00808249|E4|Reported Event|D-Placebo|Placebo
476566|NCT00808249|E3|Reported Event|C-AZD7325 10 mg|AZD7325 10 mg QD
476567|NCT00808249|E2|Reported Event|B-AZD7325 5 mg|AZD7325 5 mg BID
476568|NCT00808249|E1|Reported Event|A-AZD7325 2 mg|AZD7325 2 mg BID
476569|NCT00808236|B3|Baseline|Total|Total of all reporting groups
476570|NCT00808236|B2|Baseline|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476571|NCT00808236|B1|Baseline|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476572|NCT00808236|P2|Participant Flow|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476573|NCT00808236|P1|Participant Flow|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476574|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476575|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476576|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476577|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476578|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476579|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476859|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
476580|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476581|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476582|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476583|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476584|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476585|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476586|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476587|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476588|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476589|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476590|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476591|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476592|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476593|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476594|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476595|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476596|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476597|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476598|NCT00808236|E2|Reported Event|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
476599|NCT00808236|E1|Reported Event|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
476600|NCT00808132|B6|Baseline|Total|Total of all reporting groups
476601|NCT00808132|B5|Baseline|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476602|NCT00808132|B4|Baseline|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476603|NCT00808132|B3|Baseline|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476604|NCT00808132|B2|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476605|NCT00808132|B1|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476606|NCT00808132|P5|Participant Flow|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476607|NCT00808132|P4|Participant Flow|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476608|NCT00808132|P3|Participant Flow|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476609|NCT00808132|P2|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476610|NCT00808132|P1|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476611|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476612|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476613|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476614|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476615|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476616|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476617|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476618|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476619|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476620|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476621|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476622|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476623|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476624|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476625|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476626|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476627|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476628|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476629|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476630|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476631|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476632|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476633|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476634|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476635|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476636|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476637|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476638|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476639|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476640|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476641|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476642|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476643|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476644|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476645|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476646|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476871|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
476647|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476648|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476649|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476650|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476651|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476652|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476653|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476654|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476655|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476656|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476657|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476658|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476659|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476660|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476661|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476662|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476663|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476664|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476665|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476666|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476667|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476668|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476669|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476670|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476671|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476672|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476673|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476674|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476675|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476676|NCT00808132|E5|Reported Event|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476872|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
476677|NCT00808132|E4|Reported Event|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476678|NCT00808132|E3|Reported Event|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476679|NCT00808132|E2|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476680|NCT00808132|E1|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
476681|NCT00808080|B1|Baseline|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)"
476682|NCT00808080|P1|Participant Flow|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
476683|NCT00808080|O1|Outcome|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
476684|NCT00808080|E1|Reported Event|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
476685|NCT00808067|B3|Baseline|Total|Total of all reporting groups
476686|NCT00808067|B2|Baseline|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476687|NCT00808067|B1|Baseline|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476688|NCT00808067|P2|Participant Flow|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476689|NCT00808067|P1|Participant Flow|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476690|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476691|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476692|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476693|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476694|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476695|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476696|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476697|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476698|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476699|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476700|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476701|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476702|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476703|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476704|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476705|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476706|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476707|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476708|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476709|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476710|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476711|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476712|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476713|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476714|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476715|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476716|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476717|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476718|NCT00808067|E2|Reported Event|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
476719|NCT00808067|E1|Reported Event|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
476720|NCT00808028|B5|Baseline|Total|Total of all reporting groups
476721|NCT00808028|B4|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476722|NCT00808028|B3|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476723|NCT00808028|B2|Baseline|rLP2086 60 mcg|Given on a 0, 2-, 6-month schedule in Stage 1.
476724|NCT00808028|B1|Baseline|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476725|NCT00808028|P4|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476726|NCT00808028|P3|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476727|NCT00808028|P2|Participant Flow|rLP2086 60 Microgram (mcg)|Given on a 0, 2-, 6-month schedule in Stage 1
476728|NCT00808028|P1|Participant Flow|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476729|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476730|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476731|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476732|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476733|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476734|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476735|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476736|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476737|NCT00808028|O3|Outcome|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
476738|NCT00808028|O2|Outcome|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
476739|NCT00808028|O1|Outcome|Control- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
476740|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476741|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476742|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476743|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476744|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476745|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476746|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476747|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476748|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476749|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476750|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476751|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
476752|NCT00808028|E11|Reported Event|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
476753|NCT00808028|E10|Reported Event|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
476754|NCT00808028|E9|Reported Event|Control-Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
476755|NCT00808028|E8|Reported Event|rLP2086 200 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
476756|NCT00808028|E7|Reported Event|rLP2086 120 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
476757|NCT00808028|E6|Reported Event|rLP2086 60 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
476758|NCT00808028|E5|Reported Event|Control-Stage 1 Follow-up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
476759|NCT00808028|E4|Reported Event|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476760|NCT00808028|E3|Reported Event|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476761|NCT00808028|E2|Reported Event|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476762|NCT00808028|E1|Reported Event|Control- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
476763|NCT00808015|B1|Baseline|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476764|NCT00808015|P1|Participant Flow|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476765|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476766|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476767|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476768|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476769|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476770|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476771|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476772|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476773|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476774|NCT00808015|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
476775|NCT00807989|B3|Baseline|Total|Total of all reporting groups
476776|NCT00807989|B2|Baseline|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
476777|NCT00807989|B1|Baseline|Carbamazepine|"Carbamazepine~Carbamazepine"
476860|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
476778|NCT00807989|P2|Participant Flow|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day"
476779|NCT00807989|P1|Participant Flow|Carbamazepine|Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses
476780|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
476781|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
476782|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
476783|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
476784|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
476785|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
476786|NCT00807989|E2|Reported Event|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
476787|NCT00807989|E1|Reported Event|Carbamazepine|"Carbamazepine~Carbamazepine"
476788|NCT00807937|B5|Baseline|Total|Total of all reporting groups
476789|NCT00807937|B4|Baseline|Placebo|Placebo
476790|NCT00807937|B3|Baseline|Lorazepam|Lorazepam 2 mg twice daily (BID)
476791|NCT00807937|B2|Baseline|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476792|NCT00807937|B1|Baseline|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476793|NCT00807937|P4|Participant Flow|Placebo|Placebo
476794|NCT00807937|P3|Participant Flow|Lorazepam|Lorazepam 2 mg twice daily (BID)
476795|NCT00807937|P2|Participant Flow|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476796|NCT00807937|P1|Participant Flow|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476797|NCT00807937|O4|Outcome|Placebo|Placebo
476798|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
476799|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476800|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476801|NCT00807937|O4|Outcome|Placebo|Placebo
476802|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
476803|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476804|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476805|NCT00807937|O4|Outcome|Placebo|Placebo
476806|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
476807|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476808|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476809|NCT00807937|O4|Outcome|Placebo|Placebo
476810|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
476811|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476812|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476813|NCT00807937|O4|Outcome|Placebo|Placebo
476814|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
476815|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476816|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476817|NCT00807937|E4|Reported Event|Placebo|Placebo
476818|NCT00807937|E3|Reported Event|Lorazepam|Lorazepam 2 mg twice daily (BID)
476819|NCT00807937|E2|Reported Event|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
476820|NCT00807937|E1|Reported Event|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
476821|NCT00807885|B10|Baseline|Total|Total of all reporting groups
476822|NCT00807885|B9|Baseline|SC Button With 27 ga X 9 mm Needle|
476823|NCT00807885|B8|Baseline|Tape-secured 20 ga Polyurethane Catheter|
476824|NCT00807885|B7|Baseline|Tegaderm-secured 20 ga Polyurethane Catheter|
476825|NCT00807885|B6|Baseline|Tape-secured 20 ga Teflon Catheter|
476826|NCT00807885|B5|Baseline|Tegaderm-secured 20 ga Teflon Catheter|
476827|NCT00807885|B4|Baseline|Tape-secured 24 ga Polyurethane Catheter|
476828|NCT00807885|B3|Baseline|Tegaderm-secured 24 ga Polyurethane Catheter|
476829|NCT00807885|B2|Baseline|Tape-secured 24 ga Teflon Catheter|
476830|NCT00807885|B1|Baseline|Tegaderm-secured 24 ga Teflon Catheter|
476831|NCT00807885|P9|Participant Flow|SC Button With 27 ga X 9 mm Needle|
476832|NCT00807885|P8|Participant Flow|Tape-secured 20 ga Polyurethane Catheter|
476833|NCT00807885|P7|Participant Flow|Tegaderm-secured 20 ga Polyurethane Catheter|
476834|NCT00807885|P6|Participant Flow|Tape-secured 20 ga Teflon Catheter|
476835|NCT00807885|P5|Participant Flow|Tegaderm-secured 20 ga Teflon Catheter|
476836|NCT00807885|P4|Participant Flow|Tape-secured 24 ga Polyurethane Catheter|
476837|NCT00807885|P3|Participant Flow|Tegaderm-secured 24 ga Polyurethane Catheter|
476838|NCT00807885|P2|Participant Flow|Tape-secured 24 ga Teflon Catheter|
476839|NCT00807885|P1|Participant Flow|Tegaderm-secured 24 ga Teflon Catheter|
476840|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
476841|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
476842|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
476843|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
476844|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
476845|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
476846|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
476847|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
476848|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
476849|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
476850|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
476851|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
476852|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
476853|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
476854|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
476873|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
476874|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
476875|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
476876|NCT00807885|E9|Reported Event|SC Button With 27 ga X 9 mm Needle|
476877|NCT00807885|E8|Reported Event|Tape-secured 20 ga Polyurethane Catheter|
476878|NCT00807885|E7|Reported Event|Tegaderm-secured 20 ga Polyurethane Catheter|
476879|NCT00807885|E6|Reported Event|Tape-secured 20 ga Teflon Catheter|
476880|NCT00807885|E5|Reported Event|Tegaderm-secured 20 ga Teflon Catheter|
476881|NCT00807885|E4|Reported Event|Tape-secured 24 ga Polyurethane Catheter|
476882|NCT00807885|E3|Reported Event|Tegaderm-secured 24 ga Polyurethane Catheter|
476883|NCT00807885|E2|Reported Event|Tape-secured 24 ga Teflon Catheter|
476884|NCT00807885|E1|Reported Event|Tegaderm-secured 24 ga Teflon Catheter|
476885|NCT00807846|B3|Baseline|Total|Total of all reporting groups
476886|NCT00807846|B2|Baseline|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476887|NCT00807846|B1|Baseline|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476888|NCT00807846|P2|Participant Flow|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476889|NCT00807846|P1|Participant Flow|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476890|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476891|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476892|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476893|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476894|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476895|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476896|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476897|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476898|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476899|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476900|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476901|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476902|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476903|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476904|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476905|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476906|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476907|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476908|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476909|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476910|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476911|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476912|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476913|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476914|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476915|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476916|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476917|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476918|NCT00807846|E2|Reported Event|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476919|NCT00807846|E1|Reported Event|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
476920|NCT00807768|B3|Baseline|Total|Total of all reporting groups
476921|NCT00807768|B2|Baseline|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476922|NCT00807768|B1|Baseline|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476923|NCT00807768|P2|Participant Flow|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476924|NCT00807768|P1|Participant Flow|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476925|NCT00807768|O2|Outcome|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476926|NCT00807768|O1|Outcome|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476966|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476967|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476968|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476969|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
478545|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
476927|NCT00807768|O2|Outcome|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476928|NCT00807768|O1|Outcome|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476929|NCT00807768|O2|Outcome|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476930|NCT00807768|O1|Outcome|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476931|NCT00807768|O2|Outcome|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476932|NCT00807768|O1|Outcome|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476933|NCT00807768|O2|Outcome|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476934|NCT00807768|O1|Outcome|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476935|NCT00807768|O2|Outcome|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476970|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476971|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476972|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476973|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476974|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476936|NCT00807768|O1|Outcome|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476937|NCT00807768|E2|Reported Event|Arm II (Brachytherapy, Paclitaxel, Carboplatin)|"Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476938|NCT00807768|E1|Reported Event|Arm I (Pelvic Radiation Therapy)|"Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies"
476939|NCT00807664|B3|Baseline|Total|Total of all reporting groups
476940|NCT00807664|B2|Baseline|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
476941|NCT00807664|B1|Baseline|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
476942|NCT00807664|P2|Participant Flow|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
476943|NCT00807664|P1|Participant Flow|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
476944|NCT00807664|O2|Outcome|Biatain Dressing|Biatain dressing is a foam wound dressing
476945|NCT00807664|O1|Outcome|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
476946|NCT00807664|O2|Outcome|Biatain Dressing|Biatain dressing is a foam wound dressing
476947|NCT00807664|O1|Outcome|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
476948|NCT00807664|O2|Outcome|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
476949|NCT00807664|O1|Outcome|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
476950|NCT00807664|E2|Reported Event|Biatain Wound Dressing|Biatain dressing is a foam wound dressing
476951|NCT00807664|E1|Reported Event|Biatain Ag Wound Dressing|Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver
476952|NCT00807573|B1|Baseline|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced NSCLC. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1, 15 and 19.
476953|NCT00807573|P1|Participant Flow|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
476954|NCT00807573|O1|Outcome|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
476955|NCT00807573|E1|Reported Event|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
476956|NCT00807560|B3|Baseline|Total|Total of all reporting groups
476957|NCT00807560|B2|Baseline|NEC-control|Nutritional Educational Control Condition
476958|NCT00807560|B1|Baseline|FBT-PO|Family Based Therapy for Pediatric Overweight
476959|NCT00807560|P2|Participant Flow|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
476960|NCT00807560|P1|Participant Flow|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
476961|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476962|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476963|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476964|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476965|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476975|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476976|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476977|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476978|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476979|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476980|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476981|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476982|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476983|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476984|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476985|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476986|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476987|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476988|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476989|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
476990|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
476991|NCT00807560|E2|Reported Event|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
476992|NCT00807560|E1|Reported Event|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
476993|NCT00807495|B6|Baseline|Total|Total of all reporting groups
476994|NCT00807495|B5|Baseline|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
476995|NCT00807495|B4|Baseline|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
476996|NCT00807495|B3|Baseline|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
476997|NCT00807495|B2|Baseline|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
476998|NCT00807495|B1|Baseline|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
476999|NCT00807495|P5|Participant Flow|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477000|NCT00807495|P4|Participant Flow|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477001|NCT00807495|P3|Participant Flow|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477002|NCT00807495|P2|Participant Flow|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477003|NCT00807495|P1|Participant Flow|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477004|NCT00807495|O5|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477005|NCT00807495|O4|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477006|NCT00807495|O3|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477007|NCT00807495|O2|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477008|NCT00807495|O1|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477009|NCT00807495|O5|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477010|NCT00807495|O4|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477011|NCT00807495|O3|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477012|NCT00807495|O2|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477013|NCT00807495|O1|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477014|NCT00807495|O5|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477015|NCT00807495|O4|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477016|NCT00807495|O3|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477017|NCT00807495|O2|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477018|NCT00807495|O1|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477019|NCT00807495|O5|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477020|NCT00807495|O4|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477021|NCT00807495|O3|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477022|NCT00807495|O2|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477023|NCT00807495|O1|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477024|NCT00807495|O5|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477025|NCT00807495|O4|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477026|NCT00807495|O3|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477027|NCT00807495|O2|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477028|NCT00807495|O1|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477029|NCT00807495|O5|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477030|NCT00807495|O4|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477031|NCT00807495|O3|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477032|NCT00807495|O2|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477071|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477033|NCT00807495|O1|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477034|NCT00807495|O5|Outcome|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477035|NCT00807495|O4|Outcome|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477036|NCT00807495|O3|Outcome|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477037|NCT00807495|O2|Outcome|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477038|NCT00807495|O1|Outcome|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477039|NCT00807495|E5|Reported Event|Alisertib 50 mg BID Starting Dose (ATL)|Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477040|NCT00807495|E4|Reported Event|Alisertib 50 mg BID Starting Dose (BL)|Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477041|NCT00807495|E3|Reported Event|Alisertib 50 mg BID Starting Dose (TFL)|Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477042|NCT00807495|E2|Reported Event|Alisertib 50 mg BID Starting Dose (MCL)|Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477043|NCT00807495|E1|Reported Event|Alisertib 50 mg BID Starting Dose (DLBL)|Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
477044|NCT00807456|B1|Baseline|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
477045|NCT00807456|P1|Participant Flow|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
477046|NCT00807456|O1|Outcome|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
477047|NCT00807456|E1|Reported Event|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
477048|NCT00807365|B1|Baseline|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
477049|NCT00807365|P1|Participant Flow|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, & 5:00 AM for 6 months."
477050|NCT00807365|O1|Outcome|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
477051|NCT00807365|E1|Reported Event|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
477052|NCT00807248|B5|Baseline|Total|Total of all reporting groups
477053|NCT00807248|B4|Baseline|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477054|NCT00807248|B3|Baseline|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477055|NCT00807248|B2|Baseline|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477056|NCT00807248|B1|Baseline|Placebo (Orally, Once Daily)|
477057|NCT00807248|P4|Participant Flow|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477058|NCT00807248|P3|Participant Flow|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477059|NCT00807248|P2|Participant Flow|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477060|NCT00807248|P1|Participant Flow|Placebo (Orally, Once Daily)|
477061|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477062|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477063|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477064|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477065|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477066|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477067|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477068|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477069|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477070|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477072|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477073|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477074|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477075|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477076|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477077|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477078|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477079|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477080|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477081|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477082|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477083|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477084|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477085|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477086|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477087|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477088|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477089|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477090|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477091|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477092|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477093|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477094|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477095|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477096|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
477097|NCT00807248|E4|Reported Event|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
477098|NCT00807248|E3|Reported Event|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
477099|NCT00807248|E2|Reported Event|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
477100|NCT00807248|E1|Reported Event|Placebo (Orally, Once Daily)|
477101|NCT00807235|B3|Baseline|Total|Total of all reporting groups
477102|NCT00807235|B2|Baseline|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477103|NCT00807235|B1|Baseline|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477104|NCT00807235|P2|Participant Flow|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477105|NCT00807235|P1|Participant Flow|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477106|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477107|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477108|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477109|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477110|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477111|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477112|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477113|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477114|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477115|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477116|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477117|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477118|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477119|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477120|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477121|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477122|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477123|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477124|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477125|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477126|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477241|NCT00807001|E3|Reported Event|IDX184 50 mg|
477127|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477128|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477129|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477130|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477131|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477132|NCT00807235|E2|Reported Event|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
477133|NCT00807235|E1|Reported Event|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
477134|NCT00807209|B4|Baseline|Total|Total of all reporting groups
477135|NCT00807209|B3|Baseline|Low Dose SKY0402|
477136|NCT00807209|B2|Baseline|Standard of Care|
477137|NCT00807209|B1|Baseline|High Dose SKY0402|
477138|NCT00807209|P3|Participant Flow|Low Dose SKY0402|
477139|NCT00807209|P2|Participant Flow|Standard of Care|
477140|NCT00807209|P1|Participant Flow|High Dose SKY0402|
477141|NCT00807209|O3|Outcome|Low Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
477142|NCT00807209|O2|Outcome|Standard of Care|Bupivacaine HCl solution (1.25 mg/mL) and epinephrine (5 mcg/mL) administered via an epidural catheter at a concentration of 0.125% (1.25 mg/mL) at a rate of 8 cc per hour
477143|NCT00807209|O1|Outcome|High Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
477144|NCT00807209|E3|Reported Event|Low Dose SKY0402|
477145|NCT00807209|E2|Reported Event|Standard of Care|
477146|NCT00807209|E1|Reported Event|High Dose SKY0402|
477147|NCT00807092|B3|Baseline|Total|Total of all reporting groups
477148|NCT00807092|B2|Baseline|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477149|NCT00807092|B1|Baseline|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477150|NCT00807092|P2|Participant Flow|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477151|NCT00807092|P1|Participant Flow|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477152|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477153|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477154|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477155|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477156|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477242|NCT00807001|E2|Reported Event|IDX184 25 mg|
477243|NCT00807001|E1|Reported Event|Placebo|
477244|NCT00806988|B3|Baseline|Total|Total of all reporting groups
477157|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477158|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477159|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477160|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477161|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477162|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477163|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477164|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477165|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477166|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477167|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477168|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477169|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477170|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477171|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477311|NCT00806676|O2|Outcome|HPV 11|
477172|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477173|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477174|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477175|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477176|NCT00807092|E2|Reported Event|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477177|NCT00807092|E1|Reported Event|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
477178|NCT00807040|B3|Baseline|Total|Total of all reporting groups
477179|NCT00807040|B2|Baseline|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
477180|NCT00807040|B1|Baseline|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
477181|NCT00807040|P2|Participant Flow|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
477182|NCT00807040|P1|Participant Flow|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
477183|NCT00807040|O2|Outcome|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
477184|NCT00807040|O1|Outcome|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
477185|NCT00807040|O2|Outcome|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
477186|NCT00807040|O1|Outcome|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
477187|NCT00807040|E2|Reported Event|Mitral Valve Replacement|"Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.~Mitral Valve Replacement: Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test."
477188|NCT00807040|E1|Reported Event|Mitral Valve Repair With Annuloplasty|"Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.~Mitral Valve Repair with Annuloplasty: The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed."
477189|NCT00807014|B3|Baseline|Total|Total of all reporting groups
477190|NCT00807014|B2|Baseline|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477191|NCT00807014|B1|Baseline|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477192|NCT00807014|P2|Participant Flow|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477193|NCT00807014|P1|Participant Flow|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477194|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477195|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477196|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477197|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477198|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477199|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477200|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477201|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477202|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477203|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477204|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477205|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477206|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477207|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477208|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477209|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477210|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477211|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477212|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477213|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477214|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477215|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477216|NCT00807014|E2|Reported Event|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
477217|NCT00807014|E1|Reported Event|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
477218|NCT00807001|B6|Baseline|Total|Total of all reporting groups
477219|NCT00807001|B5|Baseline|IDX184 100 mg|
477220|NCT00807001|B4|Baseline|IDX184 75 mg|
477221|NCT00807001|B3|Baseline|IDX184 50 mg|
477222|NCT00807001|B2|Baseline|IDX184 25 mg|
477223|NCT00807001|B1|Baseline|Placebo|
477224|NCT00807001|P5|Participant Flow|IDX184 100 mg|
477225|NCT00807001|P4|Participant Flow|IDX184 75 mg|
477226|NCT00807001|P3|Participant Flow|IDX184 50 mg|
477227|NCT00807001|P2|Participant Flow|IDX184 25 mg|
477228|NCT00807001|P1|Participant Flow|Placebo|
477229|NCT00807001|O5|Outcome|IDX184 100 mg|
477230|NCT00807001|O4|Outcome|IDX184 75 mg|
477231|NCT00807001|O3|Outcome|IDX184 50 mg|
477232|NCT00807001|O2|Outcome|IDX184 25 mg|
477233|NCT00807001|O1|Outcome|Placebo|
477234|NCT00807001|O5|Outcome|IDX184 100 mg|
477235|NCT00807001|O4|Outcome|IDX184 75 mg|
477236|NCT00807001|O3|Outcome|IDX184 50 mg|
477237|NCT00807001|O2|Outcome|IDX184 25 mg|
477238|NCT00807001|O1|Outcome|Placebo|
477239|NCT00807001|E5|Reported Event|IDX184 100 mg|
477240|NCT00807001|E4|Reported Event|IDX184 75 mg|
477245|NCT00806988|B2|Baseline|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
477246|NCT00806988|B1|Baseline|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
477247|NCT00806988|P2|Participant Flow|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
477248|NCT00806988|P1|Participant Flow|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
477249|NCT00806988|O2|Outcome|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
477250|NCT00806988|O1|Outcome|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
477251|NCT00806988|O2|Outcome|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
477252|NCT00806988|O1|Outcome|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
477253|NCT00806988|E2|Reported Event|CABG|"Participants will undergo CABG.~CABG: CABG will be performed using standard surgical techniques. Conduit selection and harvesting methods will not be prescribed, except that utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, within the judgment of the surgical investigator."
477254|NCT00806988|E1|Reported Event|Mitral Valve Repair|"Participants will undergo CABG and a mitral valve repair procedure.~Mitral Valve Repair: Surgical techniques for mitral valve repair may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation. The common elements for mitral annuloplasty planned as part of this study include the following:~All procedures will be performed with cardiopulmonary bypass (CPB) and with moderate hypothermia. Cannulation will be central with aortic cannulation for arterial inflow from the cardiopulmonary bypass circuit. Right atrial or bicaval (inferior and superior vena cava) drainage cannulas will be employed.~The heart will be arrested with cardioplegia.~A complete annular ring shall be placed unless specifically contraindicated by intra-operative findings. Additional repair of the mitral apparatus itself will be based on intra-operative findings.~CABG: CABG will be performed using"
477255|NCT00806819|B3|Baseline|Total|Total of all reporting groups
477256|NCT00806819|B2|Baseline|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477257|NCT00806819|B1|Baseline|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477258|NCT00806819|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477259|NCT00806819|P1|Participant Flow|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477260|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477261|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477262|NCT00806819|O2|Outcome|Nintedanib 150 mg Bid Plus Pemetrexed|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
477263|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477264|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477265|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477266|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477267|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477268|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477269|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477270|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477312|NCT00806676|O1|Outcome|HPV 6|HPV genotype
477313|NCT00806676|O4|Outcome|HPV 18|
477314|NCT00806676|O3|Outcome|HPV 16|
477271|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477272|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477273|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477274|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477275|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477276|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477277|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477278|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477279|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477280|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477281|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477282|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477283|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477284|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477315|NCT00806676|O2|Outcome|HPV 11|
477316|NCT00806676|O1|Outcome|HPV 6|HPV genotype
477317|NCT00806676|O4|Outcome|HPV 18|
477318|NCT00806676|O3|Outcome|HPV 16|
477319|NCT00806676|O2|Outcome|HPV 11|
477320|NCT00806676|O1|Outcome|HPV 6|HPV genotype
478546|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
477285|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477286|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477287|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477288|NCT00806819|E2|Reported Event|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477289|NCT00806819|E1|Reported Event|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
477290|NCT00806676|B4|Baseline|Total|Total of all reporting groups
477291|NCT00806676|B3|Baseline|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477292|NCT00806676|B2|Baseline|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477293|NCT00806676|B1|Baseline|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477294|NCT00806676|P3|Participant Flow|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477295|NCT00806676|P2|Participant Flow|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477296|NCT00806676|P1|Participant Flow|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477297|NCT00806676|O4|Outcome|HPV 18|
477298|NCT00806676|O3|Outcome|HPV 16|
477299|NCT00806676|O2|Outcome|HPV 11|
477300|NCT00806676|O1|Outcome|HPV 6|HPV genotype
477301|NCT00806676|O4|Outcome|HPV 18|
477302|NCT00806676|O3|Outcome|HPV 16|
477303|NCT00806676|O2|Outcome|HPV 11|
477304|NCT00806676|O1|Outcome|HPV 6|HPV genotype
477305|NCT00806676|O4|Outcome|HPV 18|
477306|NCT00806676|O3|Outcome|HPV 16|
477307|NCT00806676|O2|Outcome|HPV 11|
477308|NCT00806676|O1|Outcome|HPV 6|HPV genotype
477309|NCT00806676|O4|Outcome|HPV 18|
477310|NCT00806676|O3|Outcome|HPV 16|
477321|NCT00806676|E3|Reported Event|3. Kidney Transplant Recipient|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477322|NCT00806676|E2|Reported Event|2. ESRD (Dialysis)|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477323|NCT00806676|E1|Reported Event|1. Chronic Kidney Disease, NKF Stage 1-4|"Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck & Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.~Gardasil® Vaccine (FDA-approved vaccination regimen): Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age."
477324|NCT00806624|B4|Baseline|Total|Total of all reporting groups
477325|NCT00806624|B3|Baseline|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
477326|NCT00806624|B2|Baseline|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477327|NCT00806624|B1|Baseline|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477328|NCT00806624|P3|Participant Flow|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
477329|NCT00806624|P2|Participant Flow|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477330|NCT00806624|P1|Participant Flow|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477331|NCT00806624|O3|Outcome|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
477332|NCT00806624|O2|Outcome|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477333|NCT00806624|O1|Outcome|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477334|NCT00806624|E3|Reported Event|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
477335|NCT00806624|E2|Reported Event|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477336|NCT00806624|E1|Reported Event|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
477337|NCT00806598|B1|Baseline|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
477338|NCT00806598|P1|Participant Flow|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
477339|NCT00806598|O1|Outcome|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + Granulocyte Colony stimulating factor (G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
477340|NCT00806598|E1|Reported Event|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
477341|NCT00806585|B6|Baseline|Total|Total of all reporting groups
477342|NCT00806585|B5|Baseline|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477343|NCT00806585|B4|Baseline|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477344|NCT00806585|B3|Baseline|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477345|NCT00806585|B2|Baseline|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
478547|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
477346|NCT00806585|B1|Baseline|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477347|NCT00806585|P5|Participant Flow|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477348|NCT00806585|P4|Participant Flow|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477349|NCT00806585|P3|Participant Flow|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477350|NCT00806585|P2|Participant Flow|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477351|NCT00806585|P1|Participant Flow|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477352|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477353|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477354|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477355|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477356|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477357|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477358|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477359|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477360|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477361|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477362|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477363|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477364|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477365|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477366|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477367|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477368|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477369|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477370|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477371|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477372|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477373|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477374|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477375|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477376|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477377|NCT00806585|E5|Reported Event|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
477378|NCT00806585|E4|Reported Event|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477379|NCT00806585|E3|Reported Event|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477380|NCT00806585|E2|Reported Event|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
477381|NCT00806585|E1|Reported Event|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
477382|NCT00806546|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
477383|NCT00806546|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
477384|NCT00806546|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
477385|NCT00806546|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
477386|NCT00806494|B1|Baseline|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477387|NCT00806494|P1|Participant Flow|Fesoterodine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477388|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477389|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477390|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477391|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477392|NCT00806494|O1|Outcome|Fesoteridine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477393|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477394|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477395|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477396|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477397|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477398|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477399|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477400|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477401|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477402|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477403|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477404|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477900|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
477405|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477406|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477407|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477408|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477409|NCT00806494|E1|Reported Event|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
477410|NCT00806442|B1|Baseline|All Study Particpants|Includes patients scheduled to receive Borage and Echium seed oil first and participants scheduled to receive placebo first.
477411|NCT00806442|P2|Participant Flow|2 - Placebo, Then Borage Seed Oil and Echium Seed Oil|Placebo (11 g of corn oil/day) 3x day for 3 weeks followed by a 3-week washout period, then Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks.
477412|NCT00806442|P1|Participant Flow|1 - Borage Seed Oil and Echium Seed Oil, Then Placebo|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks followed a 3-week washout period, then Placebo (11 g/day corn oil) 3x day for 3 weeks.
477413|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
477414|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477415|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
477416|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477417|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
477418|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477419|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
477420|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477421|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
477422|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477423|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
477424|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477425|NCT00806442|O2|Outcome|Placebo|Placebo (11 g of corn oil/day)
477426|NCT00806442|O1|Outcome|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477427|NCT00806442|E4|Reported Event|Washout After Placebo|Washout period between first (placebo) and second (plant seed oil) treatment assignments
477428|NCT00806442|E3|Reported Event|Washout After Plant Seed Oil|Washout period between first (plant seed oil) and second (placebo) treatment assignments
477429|NCT00806442|E2|Reported Event|Placebo|Placebo (11 g of corn oil/day)
477430|NCT00806442|E1|Reported Event|Plant Seed Oil|Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)
477431|NCT00806416|B3|Baseline|Total|Total of all reporting groups
477432|NCT00806416|B2|Baseline|Part II|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
477433|NCT00806416|B1|Baseline|Part I|70 mg alendronate/2800-IU vitamin D3 combination tablet; 70 mg alendronate tablet
477434|NCT00806416|P4|Participant Flow|Vitamin D Then Alendronate/Vitamin D Combination|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
477435|NCT00806416|P3|Participant Flow|Alendronate/Vitamin D Combination Then Vitamin D|70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet
477436|NCT00806416|P2|Participant Flow|Alendronate Then Alendronate/Vitamin D Combination|70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet
477437|NCT00806416|P1|Participant Flow|Alendronate/Vitamin D Combination Then Alendronate|70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet
477438|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
477439|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
477440|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
477441|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
477442|NCT00806416|O2|Outcome|Alendronate|70 mg alendronate tablet
477443|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
477444|NCT00806416|E3|Reported Event|Vitamin D|2800-IU vitamin D3 tablet
477445|NCT00806416|E2|Reported Event|Alendronate|70 mg alendronate tablet
477446|NCT00806416|E1|Reported Event|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
477447|NCT00806403|B3|Baseline|Total|Total of all reporting groups
477529|NCT00806234|B3|Baseline|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
477448|NCT00806403|B2|Baseline|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
477449|NCT00806403|B1|Baseline|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
477450|NCT00806403|P2|Participant Flow|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
477451|NCT00806403|P1|Participant Flow|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
477452|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
477453|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
477454|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
477455|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
477456|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
477457|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
477458|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
477459|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
477460|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
477461|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
477462|NCT00806390|B3|Baseline|Total|Total of all reporting groups
477463|NCT00806390|B2|Baseline|Control|Not receiving metoprolol
477464|NCT00806390|B1|Baseline|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
477465|NCT00806390|P2|Participant Flow|Control|Not receiving metoprolol
477466|NCT00806390|P1|Participant Flow|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
477467|NCT00806390|O2|Outcome|Control|Not receiving metoprolol
477468|NCT00806390|O1|Outcome|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
477469|NCT00806390|E2|Reported Event|Control|Not receiving metoprolol
477470|NCT00806390|E1|Reported Event|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
477471|NCT00806351|B3|Baseline|Total|Total of all reporting groups
477472|NCT00806351|B2|Baseline|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477473|NCT00806351|B1|Baseline|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477901|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
479238|NCT00802841|E4|Reported Event|Cross-over to Imatinib|600 mg QD
477474|NCT00806351|P2|Participant Flow|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477475|NCT00806351|P1|Participant Flow|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477476|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477477|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477478|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477479|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477480|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477481|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477482|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477530|NCT00806234|B2|Baseline|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
477906|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
477483|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477484|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477485|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477486|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477487|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477488|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477489|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477490|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477491|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477531|NCT00806234|B1|Baseline|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
477907|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
477492|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477493|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477494|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477495|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477496|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477497|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477498|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477499|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477500|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477532|NCT00806234|P3|Participant Flow|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
477902|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
477501|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477502|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477503|NCT00806351|E2|Reported Event|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477504|NCT00806351|E1|Reported Event|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
477505|NCT00806260|B7|Baseline|Total|Total of all reporting groups
477506|NCT00806260|B6|Baseline|Alcohol Placebo Only|Subject in this study arm only participated in period 1 and were given alcohol placebo.
477507|NCT00806260|B5|Baseline|Alcohol Only|Subjects in this study arm only participated in period 1 and were given alcohol.
477508|NCT00806260|B4|Baseline|Alcohol Placebo, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3.
477509|NCT00806260|B3|Baseline|Alcohol Placebo, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3.
477510|NCT00806260|B2|Baseline|Alcohol, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.
477511|NCT00806260|B1|Baseline|Alcohol, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3.
477512|NCT00806260|P6|Participant Flow|Alcohol-placebo Only|Alcohol-placebo was administered during period one after which the subject's participation ended.
477513|NCT00806260|P5|Participant Flow|Alcohol Only|Alcohol was administered during period one after which the subject's participation ended.
477514|NCT00806260|P4|Participant Flow|Alcohol-placebo, VI-0521 Then VI-0521-placebo|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
477515|NCT00806260|P3|Participant Flow|Alcohol-placebo, VI-0521-placebo Then VI-0521|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
477516|NCT00806260|P2|Participant Flow|Alcohol, VI-0521 Then VI-0521 Placebo|Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
477517|NCT00806260|P1|Participant Flow|Alcohol, VI-0521 Placebo Then VI-0521|Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
477518|NCT00806260|O4|Outcome|Period 3 VI-0521|phentermine/topiramate
477519|NCT00806260|O3|Outcome|Period 3 VI-0521-placebo|placebo
477520|NCT00806260|O2|Outcome|Period 2 VI-0521|phentermine/topiramate
477521|NCT00806260|O1|Outcome|Period 2 VI-0521-placebo|Placebo
477522|NCT00806260|O2|Outcome|Period 1 Alcohol|Alcohol
477523|NCT00806260|O1|Outcome|Period 1 Alcohol-placebo|fruit juice
477524|NCT00806260|E4|Reported Event|Period 2 and 3 Qnexa|The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population.
477525|NCT00806260|E3|Reported Event|Period 2 and 3 Placebo|Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population.
477526|NCT00806260|E2|Reported Event|Period 1 Alcohol|
477527|NCT00806260|E1|Reported Event|Period 1 Placebo|
477528|NCT00806234|B4|Baseline|Total|Total of all reporting groups
477555|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
477556|NCT00806221|E1|Reported Event|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
477533|NCT00806234|P2|Participant Flow|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
477534|NCT00806234|P1|Participant Flow|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
477535|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
477536|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
477537|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
477538|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
477539|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
477540|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
477541|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
477542|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
477543|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
477544|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
477545|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
477546|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
477547|NCT00806234|E3|Reported Event|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
477548|NCT00806234|E2|Reported Event|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
477549|NCT00806234|E1|Reported Event|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
477550|NCT00806221|B1|Baseline|Emollient|"Skin barrier protection from birth~emollient (Cetaphil cream): Cetaphil cream applied daily from birth"
477551|NCT00806221|P1|Participant Flow|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
477552|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
477553|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
477554|NCT00806221|O1|Outcome|Emollient|Emollient (Cetaphil cream): Cetaphil cream applied daily from birth
477558|NCT00806195|B4|Baseline|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
477559|NCT00806195|B3|Baseline|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
477560|NCT00806195|B2|Baseline|Routine Vaccines (Non-Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
477561|NCT00806195|B1|Baseline|MenACWY-CRM197 + Routine Vaccines (Non-Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
477562|NCT00806195|P4|Participant Flow|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs."
477563|NCT00806195|P3|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
477564|NCT00806195|P2|Participant Flow|Routine Vaccines (Non-detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
477565|NCT00806195|P1|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Non-detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE)."
477566|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
477567|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
477568|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
477583|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
477903|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
478548|NCT00804648|E3|Reported Event|Timolol Maleate Gel Forming Solution 0.5%|
477569|NCT00806195|O1|Outcome|MenACWY-CRM 197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
477570|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
477571|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
477572|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
477573|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
477574|NCT00806195|E2|Reported Event|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
477575|NCT00806195|E1|Reported Event|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
477576|NCT00806078|B3|Baseline|Total|Total of all reporting groups
477577|NCT00806078|B2|Baseline|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
477578|NCT00806078|B1|Baseline|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
477579|NCT00806078|P2|Participant Flow|Quinine With Chocolate Pudding First|Participants were randomized to receive a single dose of Quinine 648 mg (2 x 324 mg capsules) opened and mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. Following a 7 day wash out period, all participants were given Quinine 648 mg (2 x 324 mg) as intact capsules under similar conditions.
477580|NCT00806078|P1|Participant Flow|Quinine Alone First|Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) as intact capsules after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize quinine pharmacokinetics after this dose. Following a 7 day wash out period, all participants were given quinine 648 mg (2 x 324 mg) as capsules opened and their contents mixed in 120 mL chocolate pudding under similar conditions.
477581|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
477582|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
478549|NCT00804648|E2|Reported Event|Timolol Maleate 0.5%|
477584|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
477585|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
477586|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
477587|NCT00806078|E2|Reported Event|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
477588|NCT00806078|E1|Reported Event|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
477589|NCT00806026|B7|Baseline|Total|Total of all reporting groups
477590|NCT00806026|B6|Baseline|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477591|NCT00806026|B5|Baseline|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477592|NCT00806026|B4|Baseline|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477593|NCT00806026|B3|Baseline|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477594|NCT00806026|B2|Baseline|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477595|NCT00806026|B1|Baseline|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477596|NCT00806026|P6|Participant Flow|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477597|NCT00806026|P5|Participant Flow|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477598|NCT00806026|P4|Participant Flow|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477599|NCT00806026|P3|Participant Flow|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477600|NCT00806026|P2|Participant Flow|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477601|NCT00806026|P1|Participant Flow|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477602|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477603|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477604|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477605|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477606|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477607|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477608|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477609|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477610|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477611|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477612|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477613|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477614|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477615|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477616|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
478550|NCT00804648|E1|Reported Event|Timolol Hemihydrate 0.5%|
477617|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477618|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477619|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477620|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477621|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477622|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477623|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477624|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477625|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477626|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477627|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477628|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477629|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477630|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477631|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477632|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
478230|NCT00805285|E1|Reported Event|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
477633|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477634|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477635|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477636|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477637|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477638|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477639|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477640|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477641|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477642|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477643|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477644|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477645|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477646|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477647|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477648|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
478231|NCT00805194|B3|Baseline|Total|Total of all reporting groups
477649|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477650|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477651|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477652|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477653|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477654|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477655|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477656|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477657|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477658|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477659|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477660|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477661|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477662|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477663|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477664|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
478551|NCT00804609|B3|Baseline|Total|Total of all reporting groups
477665|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477666|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477667|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477668|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477669|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477670|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477671|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477672|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477673|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477674|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477675|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477676|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477677|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477678|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477679|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477680|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477681|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477682|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477683|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477684|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477685|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
477686|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477687|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477688|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477689|NCT00806026|E6|Reported Event|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477690|NCT00806026|E5|Reported Event|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477691|NCT00806026|E4|Reported Event|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477692|NCT00806026|E3|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477693|NCT00806026|E2|Reported Event|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
477694|NCT00806026|E1|Reported Event|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
477695|NCT00805961|B1|Baseline|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
477696|NCT00805961|P1|Participant Flow|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
477697|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
477698|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
477699|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
477700|NCT00805961|E1|Reported Event|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
477701|NCT00805935|B5|Baseline|Total|Total of all reporting groups
477702|NCT00805935|B4|Baseline|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477703|NCT00805935|B3|Baseline|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477704|NCT00805935|B2|Baseline|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477705|NCT00805935|B1|Baseline|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477706|NCT00805935|P4|Participant Flow|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477707|NCT00805935|P3|Participant Flow|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477708|NCT00805935|P2|Participant Flow|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477709|NCT00805935|P1|Participant Flow|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477710|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477711|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477712|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477713|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477714|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477715|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477904|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
477716|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477717|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477718|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477719|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477720|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477721|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477722|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477723|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477724|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477725|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477726|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477727|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477728|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477729|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477730|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477731|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477732|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477905|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
477733|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477734|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477735|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477736|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477737|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477738|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477739|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477740|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477741|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477742|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477743|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477744|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477745|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477746|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477747|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477748|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477779|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477749|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477750|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477751|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
477752|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477753|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477754|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477755|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477756|NCT00805935|E4|Reported Event|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477757|NCT00805935|E3|Reported Event|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477758|NCT00805935|E2|Reported Event|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477759|NCT00805935|E1|Reported Event|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
477760|NCT00805870|B3|Baseline|Total|Total of all reporting groups
477761|NCT00805870|B2|Baseline|Control|Wheat Germ Oil, 3 grams/day for 65 days
477762|NCT00805870|B1|Baseline|Fish Oil|Lovaza, 3 grams/day for 65 days
477763|NCT00805870|P2|Participant Flow|Control|Wheat Germ Oil, 3 grams/day for 65 days
477764|NCT00805870|P1|Participant Flow|Fish Oil|Lovaza, 3 grams/day for 65 days
477765|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
477766|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
477767|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
477768|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
477769|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
477770|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
477771|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
477772|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
477773|NCT00805870|E2|Reported Event|Control|Wheat Germ Oil, 3 grams/day for 65 days
477774|NCT00805870|E1|Reported Event|Fish Oil|Lovaza, 3 grams/day for 65 days
477775|NCT00805792|B1|Baseline|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477776|NCT00805792|P1|Participant Flow|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477777|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477778|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477780|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477781|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477782|NCT00805792|E1|Reported Event|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
477783|NCT00805766|B1|Baseline|TA-650|
477784|NCT00805766|P1|Participant Flow|TA-650|"Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal.~Increased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal."
477785|NCT00805766|O2|Outcome|Increased Dose Period|
477786|NCT00805766|O1|Outcome|Screening Period|
477787|NCT00805766|O1|Outcome|TA-650|
477788|NCT00805766|O1|Outcome|TA-650|
477789|NCT00805766|O1|Outcome|TA-650|
477790|NCT00805766|O1|Outcome|TA-650|
477791|NCT00805766|O1|Outcome|TA-650|
477792|NCT00805766|E3|Reported Event|Increased Dose Period|
477793|NCT00805766|E2|Reported Event|Screening Period|
477794|NCT00805766|E1|Reported Event|Entire Evaluation Period|Screening Period + Increased Dose Period
477795|NCT00805740|B3|Baseline|Total|Total of all reporting groups
477796|NCT00805740|B2|Baseline|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477797|NCT00805740|B1|Baseline|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477798|NCT00805740|P2|Participant Flow|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477799|NCT00805740|P1|Participant Flow|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477800|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477801|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477802|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477803|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477804|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477805|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477806|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477807|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477808|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477809|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477810|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477811|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477812|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477813|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477814|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477815|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477816|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477817|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477818|NCT00805740|E2|Reported Event|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477819|NCT00805740|E1|Reported Event|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
477820|NCT00805675|B4|Baseline|Total|Total of all reporting groups
477898|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
478712|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
477821|NCT00805675|B3|Baseline|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477822|NCT00805675|B2|Baseline|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477823|NCT00805675|B1|Baseline|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477824|NCT00805675|P3|Participant Flow|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477825|NCT00805675|P2|Participant Flow|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477826|NCT00805675|P1|Participant Flow|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477827|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477828|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477829|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477830|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477831|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477832|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477833|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477834|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477835|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477836|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477837|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477838|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477839|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477840|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477841|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477842|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
482325|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
477843|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477844|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477845|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477846|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477847|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477848|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477849|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477850|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477851|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477852|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477853|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
482326|NCT00795145|O1|Outcome|Cohort 2: 900 mg Linezolid|
477854|NCT00805675|E3|Reported Event|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477855|NCT00805675|E2|Reported Event|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477856|NCT00805675|E1|Reported Event|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
477857|NCT00805545|B3|Baseline|Total|Total of all reporting groups
477858|NCT00805545|B2|Baseline|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
477859|NCT00805545|B1|Baseline|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
477860|NCT00805545|P2|Participant Flow|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
477861|NCT00805545|P1|Participant Flow|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
477862|NCT00805545|O2|Outcome|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
477863|NCT00805545|O1|Outcome|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
477864|NCT00805545|E2|Reported Event|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
477865|NCT00805545|E1|Reported Event|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
477866|NCT00805493|B4|Baseline|Total|Total of all reporting groups
477867|NCT00805493|B3|Baseline|Not Randomized|
477868|NCT00805493|B2|Baseline|Placebo|
477869|NCT00805493|B1|Baseline|Riluzole|
477870|NCT00805493|P3|Participant Flow|Not Randomized|Those who withdrew prior to the decision to randomize
477871|NCT00805493|P2|Participant Flow|Placebo|Those randomized to receive placebo
477872|NCT00805493|P1|Participant Flow|Riluzole|Those randomized to riluzole
477873|NCT00805493|O3|Outcome|Riluzole|The group randomized to receive riluzole
477874|NCT00805493|O2|Outcome|Not Randomized|Participants who withdrew prior to the decision to randomize
477875|NCT00805493|O1|Outcome|Placebo|The group randomized to receive placebo
477876|NCT00805493|O3|Outcome|Not Randomized|Those who withdrew prior to the decision to randomize
477877|NCT00805493|O2|Outcome|Placebo|
477878|NCT00805493|O1|Outcome|Riluzole|The group randomized to riluzole
477879|NCT00805493|E3|Reported Event|Not Randomized|
477880|NCT00805493|E2|Reported Event|Placebo|
477881|NCT00805493|E1|Reported Event|Riluzole|
477882|NCT00805480|B5|Baseline|Total|Total of all reporting groups
477883|NCT00805480|B4|Baseline|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
477884|NCT00805480|B3|Baseline|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
477885|NCT00805480|B2|Baseline|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
477886|NCT00805480|B1|Baseline|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
477887|NCT00805480|P4|Participant Flow|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
477888|NCT00805480|P3|Participant Flow|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
477889|NCT00805480|P2|Participant Flow|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
477890|NCT00805480|P1|Participant Flow|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
477891|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
477892|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
477893|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
477894|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
477895|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
477896|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
477897|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
477899|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
477908|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
477909|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
477910|NCT00805480|E4|Reported Event|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
477911|NCT00805480|E3|Reported Event|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
477912|NCT00805480|E2|Reported Event|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
477913|NCT00805480|E1|Reported Event|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
477914|NCT00805467|B5|Baseline|Total|Total of all reporting groups
477915|NCT00805467|B4|Baseline|Fostamatinib 100 mg Bid|Oral treatment
477916|NCT00805467|B3|Baseline|Fostamatinib 150 mg qd|Oral treatment
477917|NCT00805467|B2|Baseline|Fostamatinib 100 mg qd|Oral treatment
477918|NCT00805467|B1|Baseline|Fostamatinib 50 mg Bid|Oral treatment
477919|NCT00805467|P4|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
477920|NCT00805467|P3|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
477921|NCT00805467|P2|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
477922|NCT00805467|P1|Participant Flow|Fostamatinib 50 mg Bid|Oral treatment
477923|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
477924|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
477925|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
477926|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
477927|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
477928|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
477929|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
477930|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
477931|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
477932|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
477933|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
477934|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
477935|NCT00805467|E4|Reported Event|50 MG BID|
477936|NCT00805467|E3|Reported Event|150 MG QD|
477937|NCT00805467|E2|Reported Event|100 MG QD|
477938|NCT00805467|E1|Reported Event|100 MG BID|
477939|NCT00805441|B3|Baseline|Total|Total of all reporting groups
477940|NCT00805441|B2|Baseline|Placebo|Daily by oral route for 12 weeks.
477941|NCT00805441|B1|Baseline|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477942|NCT00805441|P2|Participant Flow|Placebo|Daily by oral route for 12 weeks.
477943|NCT00805441|P1|Participant Flow|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477944|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477945|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477946|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477947|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477948|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477949|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477950|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477951|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477952|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477953|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477954|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477955|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477956|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477957|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477958|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477959|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477960|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477961|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477962|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477963|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477964|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477965|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477966|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477967|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477968|NCT00805441|O2|Outcome|Placebo|Daily by oral route for 12 weeks.
477969|NCT00805441|O1|Outcome|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477970|NCT00805441|E2|Reported Event|Placebo|Daily by oral route for 12 weeks.
477971|NCT00805441|E1|Reported Event|LY686017|50 milligrams (mg) daily by oral route for 12 weeks.
477972|NCT00805389|B6|Baseline|Total|Total of all reporting groups
477973|NCT00805389|B5|Baseline|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478312|NCT00804999|B1|Baseline|Non Contact Lens Wearers Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
477974|NCT00805389|B4|Baseline|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477975|NCT00805389|B3|Baseline|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477976|NCT00805389|B2|Baseline|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477977|NCT00805389|B1|Baseline|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477978|NCT00805389|P5|Participant Flow|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477979|NCT00805389|P4|Participant Flow|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477980|NCT00805389|P3|Participant Flow|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477981|NCT00805389|P2|Participant Flow|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477982|NCT00805389|P1|Participant Flow|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477983|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477984|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477985|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478232|NCT00805194|B2|Baseline|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
482327|NCT00795145|O3|Outcome|Cohort 2: 1200 mg Linezolid|
477986|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477987|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477988|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477989|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477990|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477991|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477992|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477993|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477994|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477995|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477996|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477997|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478233|NCT00805194|B1|Baseline|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
482328|NCT00795145|O2|Outcome|Cohort 2: 600 mg Linezolid|
477998|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
477999|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478000|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478001|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478002|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478003|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478004|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478005|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478006|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478007|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478008|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478009|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478234|NCT00805194|P2|Participant Flow|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478483|NCT00804687|B1|Baseline|Entire Study Population|Includes all participants randomized in the study.
478010|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478011|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478012|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478013|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478014|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478015|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478016|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478017|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478018|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478019|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478020|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478021|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478235|NCT00805194|P1|Participant Flow|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478520|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
478022|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478023|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478024|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478025|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478026|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478027|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478028|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478029|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478030|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478031|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478032|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478033|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478034|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478035|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478036|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478037|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478038|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478039|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478040|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478041|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478042|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478043|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478044|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478045|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478046|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478047|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478236|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478048|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478049|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478050|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478051|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478052|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478053|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478054|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478055|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478056|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478057|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478058|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478059|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478237|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478250|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478060|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478061|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478062|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478063|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478064|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478065|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478066|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478067|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478068|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478069|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478070|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478071|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478238|NCT00805194|O2|Outcome|Nintedanib 150 Bid mg Plus Docetaxel|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478310|NCT00804999|B3|Baseline|Overnight Soaking in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478072|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478073|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478074|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478075|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478076|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478077|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478078|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478079|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478080|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478081|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478082|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478083|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478084|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478311|NCT00804999|B2|Baseline|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
478085|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478086|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478087|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478088|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478089|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478090|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478091|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478092|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478093|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478094|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478095|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478096|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478097|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478239|NCT00805194|O1|Outcome|Nitedanib 200 mg Bid Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478098|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478099|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478100|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478101|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478102|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478103|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478104|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478105|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478106|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478107|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478108|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478109|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478110|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478521|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478111|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478112|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478113|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478114|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478115|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478116|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478117|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478118|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478119|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478120|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478121|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478122|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478123|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478124|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478240|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478522|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478125|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
478126|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478127|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478128|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478129|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478130|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478131|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478132|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478133|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478134|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478135|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478136|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478137|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478241|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478242|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478138|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478139|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478140|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478141|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478142|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478143|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478144|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478145|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478146|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478147|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478148|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478149|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478150|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478243|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478523|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
478524|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478151|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478152|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478153|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478154|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478155|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478156|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478157|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478158|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478159|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478160|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478161|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478162|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478163|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478244|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478525|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478526|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
478164|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478165|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478166|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478167|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478168|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478169|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478170|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478171|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478172|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478173|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478174|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478175|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478245|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478246|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478176|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478177|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478178|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478179|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478180|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478181|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478182|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478183|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478184|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478185|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478186|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478187|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478247|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478527|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478188|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478189|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478190|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478191|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478192|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478193|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478194|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478195|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478196|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478197|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478198|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478199|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478248|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 (with dose reduction to 60 mg/m2 if required) once every 3 weeks administered via intravenous infusion over 1 hour (h).
478528|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478200|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478201|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478202|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478203|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478204|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478205|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478206|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478207|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478208|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478209|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478210|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478211|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478249|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478529|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
478212|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478213|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478214|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478215|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478216|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478217|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478218|NCT00805389|E5|Reported Event|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478219|NCT00805389|E4|Reported Event|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478220|NCT00805389|E3|Reported Event|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478221|NCT00805389|E2|Reported Event|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478222|NCT00805389|E1|Reported Event|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
478223|NCT00805285|B1|Baseline|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
478224|NCT00805285|P1|Participant Flow|Combination Oral Budesonide and Rectal Hydrocortisone|Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
478225|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
478226|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
478227|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
478228|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
478229|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
478251|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478252|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478253|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478254|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478255|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478256|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478257|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478258|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478259|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478260|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478261|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478262|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478263|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478264|NCT00805194|E2|Reported Event|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478265|NCT00805194|E1|Reported Event|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
478266|NCT00805142|B3|Baseline|Total|Total of all reporting groups
478267|NCT00805142|B2|Baseline|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478268|NCT00805142|B1|Baseline|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478269|NCT00805142|P2|Participant Flow|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478302|NCT00805025|B1|Baseline|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
478303|NCT00805025|P1|Participant Flow|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of aztreonam for inhalation solution (AZLI) 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
478530|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478270|NCT00805142|P1|Participant Flow|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478271|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478272|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478273|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478274|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478275|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478276|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478277|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478304|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
478305|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
478278|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478279|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478280|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478281|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478282|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478283|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478284|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478306|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
478307|NCT00805025|E1|Reported Event|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
478308|NCT00804999|B5|Baseline|Total|Total of all reporting groups
478285|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478286|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478287|NCT00805142|O2|Outcome|Opioid-Switch Participants Titration Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Initial dose of tapentadol PR was selected according to the daily dose of opioid (morphine sustained release (SR) preparation, oxycodone hydrochloride (HCl) SR tablet or fentanyl patch). Equivalent dose of the tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day.
478288|NCT00805142|O1|Outcome|Opioid-Naive Participants Titration Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Treatment was initiated with tapentadol PR 25 mg oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day.
478289|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478290|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478291|NCT00805142|E2|Reported Event|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
478292|NCT00805142|E1|Reported Event|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
478293|NCT00805038|B3|Baseline|Total|Total of all reporting groups
478294|NCT00805038|B2|Baseline|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
478295|NCT00805038|B1|Baseline|Usual Care|Usual care received by participants
478296|NCT00805038|P2|Participant Flow|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
478297|NCT00805038|P1|Participant Flow|Usual Care|Usual care received by participants
478298|NCT00805038|O2|Outcome|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
478299|NCT00805038|O1|Outcome|Usual Care|Usual care received by participants
478300|NCT00805038|E2|Reported Event|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
478301|NCT00805038|E1|Reported Event|Usual Care|Usual care received by participants
478309|NCT00804999|B4|Baseline|Overnight Soaking in Optifree Replinish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478531|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478313|NCT00804999|P4|Participant Flow|Overnight Soak in Optifree Replnish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478314|NCT00804999|P3|Participant Flow|Overnight Soak in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478315|NCT00804999|P2|Participant Flow|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
478316|NCT00804999|P1|Participant Flow|Non Contact Wearer Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
478317|NCT00804999|O4|Outcome|Overnight Soaking in Optifree Replinish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478318|NCT00804999|O3|Outcome|Overnight Soaking in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478319|NCT00804999|O2|Outcome|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
478320|NCT00804999|O1|Outcome|Non Contact Wearing Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
478321|NCT00804999|E4|Reported Event|Overnight Soaking in Optifree Replinish|"ReNu and RepleniSH~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478322|NCT00804999|E3|Reported Event|Overnight Soaking in Optifree|"RepleniSH with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution~OPTI-FREE RepleniSH MPDS: overnight soak in solution"
478323|NCT00804999|E2|Reported Event|Overnight Soaking With Renu|"ReNu with and without sodium fluorescein~ReNu MultiPlus MPS: overnight soak in solution"
478324|NCT00804999|E1|Reported Event|Non Contact Wearing Using Clear Care|"neutralized Clear Care and no contact lens wear~Clear Care: neutralized Clear Care"
478325|NCT00804986|B7|Baseline|Total|Total of all reporting groups
478326|NCT00804986|B6|Baseline|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478327|NCT00804986|B5|Baseline|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478328|NCT00804986|B4|Baseline|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478329|NCT00804986|B3|Baseline|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478330|NCT00804986|B2|Baseline|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478331|NCT00804986|B1|Baseline|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478332|NCT00804986|P6|Participant Flow|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478333|NCT00804986|P5|Participant Flow|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478334|NCT00804986|P4|Participant Flow|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478335|NCT00804986|P3|Participant Flow|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478336|NCT00804986|P2|Participant Flow|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478337|NCT00804986|P1|Participant Flow|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478338|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478339|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478340|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478341|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478342|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478343|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478344|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478345|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478346|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478347|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478348|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478349|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478350|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478351|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478352|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478353|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478354|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478355|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478356|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478357|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478358|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478359|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478360|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478361|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478362|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478363|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478364|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478365|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478366|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478367|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478368|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478369|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478370|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478371|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478372|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478373|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478374|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478375|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478376|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478377|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478378|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478379|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478380|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478381|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478532|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
478382|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478383|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478384|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478385|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478386|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478387|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478388|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478389|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478390|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478391|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478392|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478393|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478394|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478395|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478396|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478397|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478398|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478399|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478400|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478401|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478402|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478403|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478404|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478405|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478406|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478407|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478408|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478409|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478410|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478411|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478412|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478413|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478414|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478533|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478415|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478416|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478417|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478418|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478419|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478420|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478421|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478422|NCT00804986|E6|Reported Event|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478423|NCT00804986|E5|Reported Event|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478424|NCT00804986|E4|Reported Event|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478425|NCT00804986|E3|Reported Event|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478426|NCT00804986|E2|Reported Event|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478427|NCT00804986|E1|Reported Event|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
478428|NCT00804908|B4|Baseline|Total|Total of all reporting groups
478429|NCT00804908|B3|Baseline|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478430|NCT00804908|B2|Baseline|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478431|NCT00804908|B1|Baseline|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478432|NCT00804908|P3|Participant Flow|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478433|NCT00804908|P2|Participant Flow|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478434|NCT00804908|P1|Participant Flow|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478435|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478436|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478437|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478438|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478439|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478440|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478441|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478442|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478443|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478444|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478445|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478446|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478447|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478534|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478448|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478449|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478450|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478451|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478452|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478453|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478454|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478455|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478456|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478457|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478458|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478459|NCT00804908|E3|Reported Event|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478460|NCT00804908|E2|Reported Event|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478461|NCT00804908|E1|Reported Event|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
478462|NCT00804843|B3|Baseline|Total|Total of all reporting groups
478463|NCT00804843|B2|Baseline|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
478464|NCT00804843|B1|Baseline|Statin 80 mg + Niacin ER|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
478465|NCT00804843|P2|Participant Flow|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
478466|NCT00804843|P1|Participant Flow|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
478467|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
478468|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
478469|NCT00804843|O2|Outcome|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~receive 10 mg Atorvastatin."
478470|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
478471|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
478472|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
478473|NCT00804843|E2|Reported Event|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~recieve 10 mg Atorvastatin."
478474|NCT00804843|E1|Reported Event|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will recieve 80 mg Atorvastatin + niacin
478475|NCT00804713|B1|Baseline|All Study Participants|Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot
478476|NCT00804713|P1|Participant Flow|All Study Participants|Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot
478477|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test~Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
478478|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot~All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.~All study participants: Administer TB Skin test~All study participants: Perform QFT-GIT TB test~All study participants: Perform T-Spot TB test"
478479|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot~All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.~All study participants: Administer TB Skin test~All study participants: Perform QFT-GIT TB test~All study participants: Perform T-Spot TB test"
478480|NCT00804713|O1|Outcome|QFT-GIT|"Subjects administered the QFT-GIT TB test~QFT-GIT: Perform QFT-GIT TB test"
478481|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test~Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
478482|NCT00804713|E1|Reported Event|All Study Participants|Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
478484|NCT00804687|P6|Participant Flow|Pseudoephedrine Then Placebo Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
478485|NCT00804687|P5|Participant Flow|Pseudoephedrine Then JNJ-39220675 Then Placebo|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
478486|NCT00804687|P4|Participant Flow|Placebo Then Pseudoephedrine Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
478487|NCT00804687|P3|Participant Flow|Placebo Then JNJ-39220675 Then Pseudoephedrine|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
478488|NCT00804687|P2|Participant Flow|JNJ-39220675 Then Placebo Then Pseudoephedrine|Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
478489|NCT00804687|P1|Participant Flow|JNJ-39220675 Then Pseudoephedrine Then Placebo|Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
478490|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
478491|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
478492|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
478493|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
478494|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
478495|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
478496|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
478497|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
478498|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
478499|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
478500|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
478501|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
478502|NCT00804687|E3|Reported Event|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
478503|NCT00804687|E2|Reported Event|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
478504|NCT00804687|E1|Reported Event|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
478505|NCT00804648|B1|Baseline|Overall|
478506|NCT00804648|P6|Participant Flow|Maleate Gel/Maleate/Hemihydrate|Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
478507|NCT00804648|P5|Participant Flow|Maleate/Hemihydrate/Maleate Gel|Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
478508|NCT00804648|P4|Participant Flow|Hemihydrate/Maleate Gel/Maleate|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
478509|NCT00804648|P3|Participant Flow|Maleate Gel/Hemihydrate/Maleate|Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
478510|NCT00804648|P2|Participant Flow|Maleate/Maleate Gel/Hemihydrate|Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
478511|NCT00804648|P1|Participant Flow|Hemihydrate/Maleate/Maleate Gel|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
478512|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478513|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478514|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
478515|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478516|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478517|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
478518|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
478519|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
478552|NCT00804609|B2|Baseline|Epidural DepoDur Following Spinal Anesthetic|"Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.~DepoDur: Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.~Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug."
478553|NCT00804609|B1|Baseline|Epidural DepoDur Following Epidural Lidocaine Administration|"Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.~DepoDur: All participant underwent cesarean delivery. An epidural top-up anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.~Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration."
478554|NCT00804609|P2|Participant Flow|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
478555|NCT00804609|P1|Participant Flow|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
478556|NCT00804609|O2|Outcome|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
478557|NCT00804609|O1|Outcome|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
478558|NCT00804609|E2|Reported Event|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
478559|NCT00804609|E1|Reported Event|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
478560|NCT00804596|B1|Baseline|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
478561|NCT00804596|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
478562|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
478563|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
478564|NCT00804596|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
478565|NCT00804570|B3|Baseline|Total|Total of all reporting groups
478566|NCT00804570|B2|Baseline|Placebo|once daily, orally, 16 weeks
478567|NCT00804570|B1|Baseline|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478568|NCT00804570|P2|Participant Flow|Placebo|once daily, orally, 16 weeks
478569|NCT00804570|P1|Participant Flow|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478570|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478571|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478572|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478573|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478574|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478575|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478576|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478577|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478578|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478579|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478580|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478581|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478582|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478583|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478584|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478585|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478586|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478587|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478588|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
478589|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
478590|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478591|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478592|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478593|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478594|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478595|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478596|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478597|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478598|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478599|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478600|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478601|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478602|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478603|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478604|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478605|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478606|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478607|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478608|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478609|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478610|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478611|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478612|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478613|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478614|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478615|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478616|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478617|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478618|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478619|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478620|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
478621|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
478622|NCT00804570|E2|Reported Event|Placebo|once daily (QD), orally (PO), 16 weeks
478623|NCT00804570|E1|Reported Event|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
478624|NCT00804193|B4|Baseline|Total|Total of all reporting groups
478625|NCT00804193|B3|Baseline|Vehicle Product|placebo of test product
478626|NCT00804193|B2|Baseline|Reference Product|Loprox® Topical Suspension 0.77%
478627|NCT00804193|B1|Baseline|Test Product|Ciclopirox Olamine Topical Suspension
478628|NCT00804193|P3|Participant Flow|Vehicle Product|placebo of test product was applied treatment two times a day for 4 weeks
478629|NCT00804193|P2|Participant Flow|Reference Product|Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks
478630|NCT00804193|P1|Participant Flow|Test Product|Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks
478631|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
478632|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
478633|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
478634|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
478635|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
478636|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
478637|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
478638|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
478639|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
478640|NCT00804193|E3|Reported Event|Vehicle Product|placebo of test product
478641|NCT00804193|E2|Reported Event|Reference Product|Loprox® Topical Suspension 0.77%
478642|NCT00804193|E1|Reported Event|Test Product|Ciclopirox Olamine Topical Suspension
478643|NCT00803959|B3|Baseline|Total|Total of all reporting groups
478644|NCT00803959|B2|Baseline|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478645|NCT00803959|B1|Baseline|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478646|NCT00803959|P2|Participant Flow|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478647|NCT00803959|P1|Participant Flow|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478648|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478649|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478650|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478651|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478652|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478653|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478654|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478655|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478656|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478657|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478658|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478659|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478660|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478661|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478662|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478663|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478664|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478665|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478666|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478667|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478668|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478669|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478670|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478671|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478672|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478673|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478674|NCT00803959|E2|Reported Event|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478675|NCT00803959|E1|Reported Event|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
478676|NCT00803790|B3|Baseline|Total|Total of all reporting groups
478677|NCT00803790|B2|Baseline|Part 2|"Alendronate+vitamin D combo, then vitamin D: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets. A washout of at least 12 days separated each treatment period.~Vitamin D, then alendronate+vitamin D combo: In Period 1 participants received a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
478713|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
478714|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
478715|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
482329|NCT00795145|O1|Outcome|Cohort 2: Placebo|
478678|NCT00803790|B1|Baseline|Part 1|"Alendronate+vitamin D combo, then alendronate: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 70mg alendronate tablet. A washout of at least 12 days separated each treatment period.~Alendronate, then alendronate+vitamin D combo: In Period 1 participants received 70mg alendronate tablet, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
478679|NCT00803790|P4|Participant Flow|Part 2 Vitamin D, Then Alendronate+Vitamin D Combo|Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
478680|NCT00803790|P3|Participant Flow|Part 2 Alendronate+Vitamin D Combo, Then Vitamin D|Participants in Part 2 received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
478681|NCT00803790|P2|Participant Flow|Part 1 Alendronate, Then Alendronate+Vitamin D Combo|Participants in Part 1 received a single dose of 70mg alendronate tablet in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
478682|NCT00803790|P1|Participant Flow|Part 1 Alendronate+Vitamin D Combo, Then Alendronate|Participants in Part 1 received a single dose of 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by a single dose of 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
478683|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
478684|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
478685|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D administered as 2 x 2800 IU tablets
478686|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|A single dose of 70mg alendronate+5600 IU vitamin D combination tablet
478687|NCT00803790|O2|Outcome|Alendronate|Single dose of 70mg alendronate tablet
478688|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70mg alendronate+5600 IU vitamin D combination tablet
478689|NCT00803790|E3|Reported Event|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
478690|NCT00803790|E2|Reported Event|Alendronate|Single dose of 70mg alendronate tablet
478691|NCT00803790|E1|Reported Event|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
478692|NCT00803777|B1|Baseline|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478693|NCT00803777|P1|Participant Flow|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478694|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478695|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478696|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478697|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478698|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478699|NCT00803777|E1|Reported Event|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
478700|NCT00803751|B3|Baseline|Total|Total of all reporting groups
478701|NCT00803751|B2|Baseline|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
478702|NCT00803751|B1|Baseline|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
478703|NCT00803751|P2|Participant Flow|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
478704|NCT00803751|P1|Participant Flow|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
478705|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
478706|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
478707|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
478708|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
478709|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
478710|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
478711|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
478716|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
478717|NCT00803751|E2|Reported Event|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
478718|NCT00803751|E1|Reported Event|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
478719|NCT00803738|B3|Baseline|Total|Total of all reporting groups
478720|NCT00803738|B2|Baseline|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
478721|NCT00803738|B1|Baseline|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
478722|NCT00803738|P2|Participant Flow|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
478723|NCT00803738|P1|Participant Flow|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
478724|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
478725|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
478726|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
478727|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
478728|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
478729|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
478730|NCT00803738|E2|Reported Event|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
478731|NCT00803738|E1|Reported Event|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
478732|NCT00803712|B3|Baseline|Total|Total of all reporting groups
478733|NCT00803712|B2|Baseline|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478734|NCT00803712|B1|Baseline|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478735|NCT00803712|P2|Participant Flow|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478736|NCT00803712|P1|Participant Flow|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478737|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478738|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478739|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478740|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478741|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478742|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478743|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478744|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478745|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478746|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478747|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478748|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478749|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478750|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478751|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478752|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478753|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478754|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478755|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478756|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478757|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478758|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478759|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478760|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478761|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478762|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478763|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478764|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478765|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478766|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478767|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478768|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478769|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478770|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478771|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478772|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478773|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478774|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478775|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478776|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478777|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478778|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478779|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478780|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478781|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478782|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478783|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478784|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478785|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478786|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478787|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478788|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478789|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478790|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478791|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478792|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478793|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478794|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478795|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478796|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478797|NCT00803712|E2|Reported Event|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
478798|NCT00803712|E1|Reported Event|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
478799|NCT00803686|B5|Baseline|Total|Total of all reporting groups
478800|NCT00803686|B4|Baseline|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
478801|NCT00803686|B3|Baseline|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
478802|NCT00803686|B2|Baseline|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
478803|NCT00803686|B1|Baseline|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
478804|NCT00803686|P4|Participant Flow|Fortical Nasal Spray (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter the open label Part 2, Period 3 and were given Fortical Nasal Spray 2 hours after the evening meal
478805|NCT00803686|P3|Participant Flow|Oral rsCT Tablets (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter open label Part 2, Period 3, and received oral rsCT tablets given 2 hours after the evening meal.
478806|NCT00803686|P2|Participant Flow|Oral Placebo|In Part 1, Period 1, 6 Subjects each were given oral placebo tablets 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral rsCT tablets 4 hours after the evening meal.
478895|NCT00803517|P2|Participant Flow|Focal Laser Photocoagulation|
478896|NCT00803517|P1|Participant Flow|Photodynamic Therapy|
478807|NCT00803686|P1|Participant Flow|Oral Recombinant Salmon Calcitonin (rsCT)|In Part 1, Period 1, 6 Subjects each were given rsCT tablets or 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral placebo 4 hours after the evening meal.
478808|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
478809|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
478810|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
478811|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
478812|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
478813|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
478814|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
478815|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
478816|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|Subjects were given Fortical (rsCT) nasal spray four hours after the evening meal
478817|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|Subjects were given oral rsCT tablets four hours after the evening meal
478818|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
478819|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
478820|NCT00803686|E4|Reported Event|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
478821|NCT00803686|E3|Reported Event|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
478822|NCT00803686|E2|Reported Event|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
478823|NCT00803686|E1|Reported Event|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
478824|NCT00803647|B1|Baseline|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478825|NCT00803647|P1|Participant Flow|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478826|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478827|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478828|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478829|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478830|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478831|NCT00803647|E1|Reported Event|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
478832|NCT00803634|B3|Baseline|Total|Total of all reporting groups
478833|NCT00803634|B2|Baseline|SOC IV Antihypertensive Therapy|All randomized and eligible patients who received any SOC dose.
478834|NCT00803634|B1|Baseline|Clevidipine Emulsion|All randomized and eligible patients who received any dose of clevidipine.
478835|NCT00803634|P2|Participant Flow|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478836|NCT00803634|P1|Participant Flow|Clevidipine|Clevidipine (0.5 mg/mL in 20% lipid emulsion) was administered intravenously via a single dedicated line to all patients randomized to the clevidipine arm. Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478837|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478838|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478839|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478897|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
478840|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478841|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478842|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478843|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478844|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478845|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478846|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478847|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478848|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478849|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478850|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478851|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478852|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478853|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478898|NCT00803517|O1|Outcome|Photodynamic Therapy|
478899|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
478900|NCT00803517|O1|Outcome|Photodynamic Therapy|
478901|NCT00803452|B3|Baseline|Total|Total of all reporting groups
478854|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478855|NCT00803634|O2|Outcome|SOC IV Therapy|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478856|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478857|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478858|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478859|NCT00803634|E2|Reported Event|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
478860|NCT00803634|E1|Reported Event|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
478861|NCT00803595|B4|Baseline|Total|Total of all reporting groups
478862|NCT00803595|B3|Baseline|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
478863|NCT00803595|B2|Baseline|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
478864|NCT00803595|B1|Baseline|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
478865|NCT00803595|P3|Participant Flow|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
478866|NCT00803595|P2|Participant Flow|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
478867|NCT00803595|P1|Participant Flow|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
478868|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
478869|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
478870|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
478871|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
478872|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
478873|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
478874|NCT00803595|E3|Reported Event|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
478875|NCT00803595|E2|Reported Event|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
478876|NCT00803595|E1|Reported Event|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
478877|NCT00803543|B3|Baseline|Total|Total of all reporting groups
478878|NCT00803543|B2|Baseline|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
478879|NCT00803543|B1|Baseline|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
478880|NCT00803543|P2|Participant Flow|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
478881|NCT00803543|P1|Participant Flow|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
478882|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
478883|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
478884|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
478885|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
478886|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
478887|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
478888|NCT00803543|O2|Outcome|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
478889|NCT00803543|O1|Outcome|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
478890|NCT00803543|E2|Reported Event|Placebo|Placebo: Dosage: Two tablets once a day for 24 weeks
478891|NCT00803543|E1|Reported Event|Valacyclovir|Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
478892|NCT00803517|B3|Baseline|Total|Total of all reporting groups
478893|NCT00803517|B2|Baseline|Focal Laser Photocoagulation|
478894|NCT00803517|B1|Baseline|Photodynamic Therapy|
478902|NCT00803452|B2|Baseline|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
478903|NCT00803452|B1|Baseline|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
478904|NCT00803452|P2|Participant Flow|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
478905|NCT00803452|P1|Participant Flow|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
478906|NCT00803452|O2|Outcome|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
478907|NCT00803452|O1|Outcome|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
478908|NCT00803452|E2|Reported Event|Azithromycin|"Topical azithromycin daily to the conjunctival culdesac~azithromycin: topical 1% azithromycin daily to eye"
478909|NCT00803452|E1|Reported Event|Doxycycline|"Oral doxycycline~doxycycline: Oral doxycycline 100mg bid"
478910|NCT00803413|B5|Baseline|Total|Total of all reporting groups
478911|NCT00803413|B4|Baseline|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
478912|NCT00803413|B3|Baseline|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
478913|NCT00803413|B2|Baseline|Supervised Walking|
478914|NCT00803413|B1|Baseline|Back School|
478915|NCT00803413|P4|Participant Flow|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
478916|NCT00803413|P3|Participant Flow|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
478917|NCT00803413|P2|Participant Flow|Supervised Walking|
478918|NCT00803413|P1|Participant Flow|Back School|
478919|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
478920|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
478921|NCT00803413|O2|Outcome|Supervised Walking|
478922|NCT00803413|O1|Outcome|Back School|
478923|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
478924|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
478925|NCT00803413|O2|Outcome|Supervised Walking|
478926|NCT00803413|O1|Outcome|Back School|
478927|NCT00803400|B3|Baseline|Total|Total of all reporting groups
478928|NCT00803400|B2|Baseline|Alprazolam + Aerobic Exercise|
478929|NCT00803400|B1|Baseline|Alprazolam|
478930|NCT00803400|P2|Participant Flow|Alprazolam + Aerobic Exercise|
478931|NCT00803400|P1|Participant Flow|Alprazolam|
478932|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
478933|NCT00803400|O1|Outcome|Alprazolam|
478934|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
478935|NCT00803400|O1|Outcome|Alprazolam|
478936|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
478937|NCT00803400|O1|Outcome|Alprazolam|
478938|NCT00803400|E2|Reported Event|Alprazolam + Aerobic Exercise|
478939|NCT00803400|E1|Reported Event|Alprazolam|
478940|NCT00803361|B3|Baseline|Total|Total of all reporting groups
478941|NCT00803361|B2|Baseline|Placebo|placebo capsules, oral, once a day for 15 weeks
478942|NCT00803361|B1|Baseline|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478943|NCT00803361|P2|Participant Flow|Placebo|placebo capsules, oral, once a day for 15 weeks
478944|NCT00803361|P1|Participant Flow|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478945|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
478946|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478947|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
478948|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478949|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
478950|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478951|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
478952|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478953|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
478954|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478955|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
478956|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478957|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
478958|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478959|NCT00803361|E2|Reported Event|Placebo|placebo capsules, oral, once a day for 15 weeks
478960|NCT00803361|E1|Reported Event|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
478961|NCT00803283|B3|Baseline|Total|Total of all reporting groups
478962|NCT00803283|B2|Baseline|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478963|NCT00803283|B1|Baseline|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478964|NCT00803283|P2|Participant Flow|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478965|NCT00803283|P1|Participant Flow|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478966|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478967|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478968|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478969|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478970|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478971|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478972|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478973|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478974|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478975|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478976|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478977|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478978|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478979|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478980|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478981|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478982|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478983|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478984|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478985|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478986|NCT00803283|E2|Reported Event|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478987|NCT00803283|E1|Reported Event|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
478988|NCT00803270|B3|Baseline|Total|Total of all reporting groups
478989|NCT00803270|B2|Baseline|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
478990|NCT00803270|B1|Baseline|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
478991|NCT00803270|P2|Participant Flow|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and~Behavioral therapy."
478992|NCT00803270|P1|Participant Flow|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
478993|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
478994|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
478995|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
478996|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
478997|NCT00803270|E2|Reported Event|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
478998|NCT00803270|E1|Reported Event|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
478999|NCT00803244|B3|Baseline|Total|Total of all reporting groups
479000|NCT00803244|B2|Baseline|Placebo|Placebo tablet
479001|NCT00803244|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
479002|NCT00803244|P2|Participant Flow|Placebo|Placebo tablet
479003|NCT00803244|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
479004|NCT00803244|O2|Outcome|Placebo|Placebo tablet
479005|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
479006|NCT00803244|O2|Outcome|Placebo|Placebo tablet
479007|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
479008|NCT00803244|E2|Reported Event|Placebo|Placebo tablet
479009|NCT00803244|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
479010|NCT00803179|B1|Baseline|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
479011|NCT00803179|P1|Participant Flow|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
479012|NCT00803179|O1|Outcome|Growth Hormone Therapy|"Nutropin Aqueous (AQ):~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
479013|NCT00803179|E1|Reported Event|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
479014|NCT00803114|B3|Baseline|Total|Total of all reporting groups
479015|NCT00803114|B2|Baseline|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
479016|NCT00803114|B1|Baseline|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
479017|NCT00803114|P2|Participant Flow|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
479018|NCT00803114|P1|Participant Flow|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
479019|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
479020|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
479021|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
479022|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
479023|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
479024|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
479025|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
479026|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
479027|NCT00803101|B3|Baseline|Total|Total of all reporting groups
479028|NCT00803101|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479029|NCT00803101|B1|Baseline|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479030|NCT00803101|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479031|NCT00803101|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (INR), amount of coagulation factor IX and body-weight.
479032|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479033|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479034|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479035|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479036|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479037|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479038|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479039|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479040|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479041|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479042|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479043|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479044|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479045|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479046|NCT00803101|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
479047|NCT00803101|E1|Reported Event|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
479048|NCT00803062|B5|Baseline|Total|Total of all reporting groups
479049|NCT00803062|B4|Baseline|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479050|NCT00803062|B3|Baseline|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
479051|NCT00803062|B2|Baseline|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479052|NCT00803062|B1|Baseline|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
479053|NCT00803062|P4|Participant Flow|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479054|NCT00803062|P3|Participant Flow|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
479055|NCT00803062|P2|Participant Flow|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479056|NCT00803062|P1|Participant Flow|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
479057|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479058|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
479059|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479200|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479060|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
479061|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479062|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
479063|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479064|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
479065|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479066|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
479067|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479068|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
479069|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479070|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
479071|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479072|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
479073|NCT00803062|E4|Reported Event|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479074|NCT00803062|E3|Reported Event|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
479075|NCT00803062|E2|Reported Event|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
479076|NCT00803062|E1|Reported Event|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
479077|NCT00803049|B5|Baseline|Total|Total of all reporting groups
479078|NCT00803049|B4|Baseline|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479079|NCT00803049|B3|Baseline|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479080|NCT00803049|B2|Baseline|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479081|NCT00803049|B1|Baseline|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479082|NCT00803049|P4|Participant Flow|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479083|NCT00803049|P3|Participant Flow|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479084|NCT00803049|P2|Participant Flow|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479237|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479085|NCT00803049|P1|Participant Flow|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479086|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479087|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479088|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479089|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479090|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479091|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479092|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479093|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479094|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479095|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479096|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479097|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479098|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479099|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479100|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479101|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479102|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479103|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479104|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479105|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479106|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479107|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
479108|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
479109|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479110|NCT00803049|E4|Reported Event|Teriflunomide 14 mg/14 mg|"Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
479111|NCT00803049|E3|Reported Event|Placebo/Teriflunomide 14 mg|"Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis."
479112|NCT00803049|E2|Reported Event|Teriflunomide 7 mg/7 mg|"Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.~Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
479113|NCT00803049|E1|Reported Event|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
479114|NCT00803023|B5|Baseline|Total|Total of all reporting groups
479115|NCT00803023|B4|Baseline|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
479116|NCT00803023|B3|Baseline|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
479117|NCT00803023|B2|Baseline|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
479118|NCT00803023|B1|Baseline|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
479119|NCT00803023|P4|Participant Flow|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
479120|NCT00803023|P3|Participant Flow|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
479121|NCT00803023|P2|Participant Flow|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
479122|NCT00803023|P1|Participant Flow|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
479123|NCT00803023|O4|Outcome|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
479124|NCT00803023|O3|Outcome|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
479125|NCT00803023|O2|Outcome|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
479126|NCT00803023|O1|Outcome|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
479127|NCT00803023|E4|Reported Event|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
479128|NCT00803023|E3|Reported Event|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
479129|NCT00803023|E2|Reported Event|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
479130|NCT00803023|E1|Reported Event|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
479131|NCT00803010|B3|Baseline|Total|Total of all reporting groups
479132|NCT00803010|B2|Baseline|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
479133|NCT00803010|B1|Baseline|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
479134|NCT00803010|P2|Participant Flow|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
479135|NCT00803010|P1|Participant Flow|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
479136|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
479137|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
479138|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
479139|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
479140|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
479141|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
479142|NCT00803010|E2|Reported Event|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
479201|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479143|NCT00803010|E1|Reported Event|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
479144|NCT00802997|B3|Baseline|Total|Total of all reporting groups
479145|NCT00802997|B2|Baseline|Sham Procedure|
479146|NCT00802997|B1|Baseline|Lateral Branch Neurotomy|
479147|NCT00802997|P2|Participant Flow|Sham Procedure|The sham procedure was identical to the active treatment procedure but without the delivery of radiofrequency energy. The sham procedure was completed one time within 60 days of enrollment.
479148|NCT00802997|P1|Participant Flow|Lateral Branch Neurotomy|The lateral branch neurotomy procedure involved the ablation of the S1-S3 lateral branches and the L5 dorsal ramus using cooled radiofrequency electrodes. The procedure was completed one time within 60 days of enrollment.
479149|NCT00802997|O2|Outcome|Sham Procedure|
479150|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
479151|NCT00802997|O2|Outcome|Sham Procedure|
479152|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
479153|NCT00802997|O2|Outcome|Sham Procedure|
479154|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
479155|NCT00802997|E2|Reported Event|Sham Procedure|
479156|NCT00802997|E1|Reported Event|Lateral Branch Neurotomy|
479157|NCT00802919|B3|Baseline|Total|Total of all reporting groups
479158|NCT00802919|B2|Baseline|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
479159|NCT00802919|B1|Baseline|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
479160|NCT00802919|P2|Participant Flow|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
479161|NCT00802919|P1|Participant Flow|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
479162|NCT00802919|O2|Outcome|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
479163|NCT00802919|O1|Outcome|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
479164|NCT00802919|O2|Outcome|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
479165|NCT00802919|O1|Outcome|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
479166|NCT00802919|O2|Outcome|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
479167|NCT00802919|O1|Outcome|Varenicline|"Varenciline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
479168|NCT00802919|O2|Outcome|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
479169|NCT00802919|O1|Outcome|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
479170|NCT00802919|E2|Reported Event|Matched Placebo|"placebo for varenicline~Placebo for varenicline: Placebo"
479171|NCT00802919|E1|Reported Event|Varenicline|"Varenicline 1-2 mg/day~Varenicline: Varenicline 1-2 mg/day"
479172|NCT00802893|B1|Baseline|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
479173|NCT00802893|P1|Participant Flow|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
479174|NCT00802893|O1|Outcome|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
479175|NCT00802893|O1|Outcome|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
479176|NCT00802893|E1|Reported Event|All Participants|"6R-BH4: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period~OR~Placebo: placebo given BID for entire length of study"
479177|NCT00802880|B1|Baseline|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479178|NCT00802880|P1|Participant Flow|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479179|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479180|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479181|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479182|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479183|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479184|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479185|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479186|NCT00802880|O4|Outcome|Total|
479187|NCT00802880|O3|Outcome|Progressive Metabolic Disease|
479188|NCT00802880|O2|Outcome|Stable Metabolic Disease|
479189|NCT00802880|O1|Outcome|Partial Metabolic Response|
479190|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479191|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479192|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479193|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479194|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479195|NCT00802880|E1|Reported Event|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
479196|NCT00802867|B1|Baseline|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479197|NCT00802867|P1|Participant Flow|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479198|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479199|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479236|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479202|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479203|NCT00802867|E1|Reported Event|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
479204|NCT00802854|B1|Baseline|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479205|NCT00802854|P1|Participant Flow|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479206|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479207|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479208|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479209|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479210|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479211|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479212|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479213|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479214|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479215|NCT00802854|O1|Outcome|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479216|NCT00802854|E1|Reported Event|Eraxis|Participants who were receiving Eraxis 100 milligram (mg) injection intravenously (IV) according to the approved indication were observed in this study. The dosage recommendations for Eraxis IV were adjusted solely according to medical and therapeutic necessity and the duration of treatment was based on the participant's clinical response.
479217|NCT00802841|B3|Baseline|Total|Total of all reporting groups
479218|NCT00802841|B2|Baseline|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479219|NCT00802841|B1|Baseline|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479220|NCT00802841|P2|Participant Flow|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479221|NCT00802841|P1|Participant Flow|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479222|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479223|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479224|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479225|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479226|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479227|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479228|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479229|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479230|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479231|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479232|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479233|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479234|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479235|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479239|NCT00802841|E3|Reported Event|Cross-over to Nilotinib|Nilotinib 400 mg BID
479240|NCT00802841|E2|Reported Event|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
479241|NCT00802841|E1|Reported Event|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
479242|NCT00802737|B4|Baseline|Total|Total of all reporting groups
479243|NCT00802737|B3|Baseline|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479244|NCT00802737|B2|Baseline|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479245|NCT00802737|B1|Baseline|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479246|NCT00802737|P3|Participant Flow|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479247|NCT00802737|P2|Participant Flow|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479248|NCT00802737|P1|Participant Flow|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479249|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
479250|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479251|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479321|NCT00802672|E2|Reported Event|Reference Product|Loprox® (ciclopirox) Cream 0.77%
479322|NCT00802672|E1|Reported Event|Test Product|Ciclopirox Olamine Cream, USP
479323|NCT00802659|B5|Baseline|Total|Total of all reporting groups
479376|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
479810|NCT00800683|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
479252|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479253|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479254|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479255|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479256|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479257|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479258|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479259|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479260|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479372|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
480065|NCT00799708|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
479261|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479262|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
479263|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479264|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479265|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479266|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479267|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479268|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479269|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479270|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479373|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
482330|NCT00795145|O2|Outcome|Cohort 2: Placebo|
479271|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479272|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479273|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479274|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479275|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479276|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479277|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479278|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479279|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479374|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
480066|NCT00799708|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
479280|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479281|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479282|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479283|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479284|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479285|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479286|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479287|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479288|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479375|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
479377|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
479289|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479290|NCT00802737|E3|Reported Event|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
479291|NCT00802737|E2|Reported Event|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
479292|NCT00802737|E1|Reported Event|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
479293|NCT00802685|B3|Baseline|Total|Total of all reporting groups
479294|NCT00802685|B2|Baseline|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
479295|NCT00802685|B1|Baseline|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
479296|NCT00802685|P2|Participant Flow|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
479297|NCT00802685|P1|Participant Flow|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
479760|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
479298|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
479299|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
479300|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
479301|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
479302|NCT00802685|E2|Reported Event|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
479303|NCT00802685|E1|Reported Event|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
479304|NCT00802672|B4|Baseline|Total|Total of all reporting groups
479305|NCT00802672|B3|Baseline|Vehicle Product|placebo
479306|NCT00802672|B2|Baseline|Reference Product|Loprox Cream
479307|NCT00802672|B1|Baseline|Test Product|Ciclopirox cream
479308|NCT00802672|P3|Participant Flow|Vehicle Product|placebo
479309|NCT00802672|P2|Participant Flow|Reference Product|Loprox Cream
479310|NCT00802672|P1|Participant Flow|Test Product|Ciclopirox cream
479311|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
479312|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
479313|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
479314|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
479315|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
479316|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
479317|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
479318|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
479319|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
479320|NCT00802672|E3|Reported Event|Vehicle Product|Vehicle
479324|NCT00802659|B4|Baseline|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479325|NCT00802659|B3|Baseline|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479326|NCT00802659|B2|Baseline|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479327|NCT00802659|B1|Baseline|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479328|NCT00802659|P4|Participant Flow|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479329|NCT00802659|P3|Participant Flow|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479330|NCT00802659|P2|Participant Flow|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479331|NCT00802659|P1|Participant Flow|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479332|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479333|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479334|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479335|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479336|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479337|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479338|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479339|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479340|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479341|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479342|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479343|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479344|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479345|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479346|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479347|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479348|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479349|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479350|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479351|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479352|NCT00802659|E4|Reported Event|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479353|NCT00802659|E3|Reported Event|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479354|NCT00802659|E2|Reported Event|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479355|NCT00802659|E1|Reported Event|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
479356|NCT00802633|B3|Baseline|Total|Total of all reporting groups
479357|NCT00802633|B2|Baseline|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
479358|NCT00802633|B1|Baseline|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
479359|NCT00802633|P2|Participant Flow|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
479360|NCT00802633|P1|Participant Flow|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
479361|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
479362|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
479363|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
479364|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
479365|NCT00802633|E2|Reported Event|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
479366|NCT00802633|E1|Reported Event|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
479367|NCT00802529|B3|Baseline|Total|Total of all reporting groups
479368|NCT00802529|B2|Baseline|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
479369|NCT00802529|B1|Baseline|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
479370|NCT00802529|P2|Participant Flow|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.Each injection was 40mg/ml.
479371|NCT00802529|P1|Participant Flow|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml.
482336|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
479378|NCT00802529|E2|Reported Event|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
479379|NCT00802529|E1|Reported Event|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
479380|NCT00802503|B3|Baseline|Total|Total of all reporting groups
479381|NCT00802503|B2|Baseline|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479382|NCT00802503|B1|Baseline|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
479383|NCT00802503|P2|Participant Flow|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479384|NCT00802503|P1|Participant Flow|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
479385|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479386|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
479387|NCT00802503|O2|Outcome|SPN gr|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479388|NCT00802503|O1|Outcome|Controle gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479389|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479390|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479391|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479392|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479393|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479394|NCT00802503|O1|Outcome|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479761|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
479395|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479396|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479397|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479398|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479399|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479400|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479401|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479402|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
479403|NCT00802503|E2|Reported Event|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
479404|NCT00802503|E1|Reported Event|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
479405|NCT00802464|B5|Baseline|Total|Total of all reporting groups
479406|NCT00802464|B4|Baseline|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479407|NCT00802464|B3|Baseline|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479408|NCT00802464|B2|Baseline|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479409|NCT00802464|B1|Baseline|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479410|NCT00802464|P4|Participant Flow|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479411|NCT00802464|P3|Participant Flow|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479412|NCT00802464|P2|Participant Flow|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479413|NCT00802464|P1|Participant Flow|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
480067|NCT00799708|P3|Participant Flow|Placebo|Placebo capsule once daily for 7 days.
479414|NCT00802464|O4|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479415|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479416|NCT00802464|O2|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479417|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479418|NCT00802464|O4|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479419|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479420|NCT00802464|O2|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479421|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479422|NCT00802464|O4|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479423|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479424|NCT00802464|O2|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479425|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479426|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479427|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479428|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479429|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479430|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479431|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479432|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479433|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479434|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479435|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479436|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479437|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479605|NCT00802100|O1|Outcome|Overall Study|This refers to the feasibility of the entire pilot study. Only 21 eligible participants of the goal of 60 were randomized because sites were unable to identify adequate numbers of eligible participants.
479438|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479439|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479440|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479441|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479442|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479443|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479444|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479445|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479446|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479447|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479448|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479449|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479450|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479451|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479452|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479453|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479454|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479455|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479456|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479457|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479458|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479459|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479460|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479461|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479606|NCT00802100|E3|Reported Event|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
479462|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479463|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479464|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479465|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479466|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479467|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479468|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479469|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479470|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479471|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479472|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479473|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479474|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479475|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479476|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479477|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479478|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479479|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479480|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479481|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479482|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479483|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479484|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479485|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479607|NCT00802100|E2|Reported Event|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
479486|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479487|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479488|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479489|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479490|NCT00802464|O4|Outcome|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479491|NCT00802464|O3|Outcome|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479492|NCT00802464|O2|Outcome|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479493|NCT00802464|O1|Outcome|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479494|NCT00802464|E4|Reported Event|GSK1437173A Formulation 1 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 1 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479495|NCT00802464|E3|Reported Event|GSK1437173A Formulation 2 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 2 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479496|NCT00802464|E2|Reported Event|GSK1437173A Formulation 3 Group|Male or female subjects, 50 years of age or above, who received 2 doses of GSK1437173A (gE/AS01B and gE/AS01E) formulation 3 vaccine, administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479497|NCT00802464|E1|Reported Event|Placebo Group|Male or female subjects, 50 years of age or above, who received 2 doses of saline solution (placebo), administered intramuscularly in the upper deltoid region of the non-dominant arm, on a 0, 2 month schedule.
479498|NCT00802438|B1|Baseline|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
479499|NCT00802438|P1|Participant Flow|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
479500|NCT00802438|O1|Outcome|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
479501|NCT00802438|O1|Outcome|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
479502|NCT00802438|E1|Reported Event|Mepolizumab|"up to 3 monthly doses of 750mg i.v. mepolizumab~mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab"
479503|NCT00802412|B3|Baseline|Total|Total of all reporting groups
479504|NCT00802412|B2|Baseline|Placebo|Received placebo
479505|NCT00802412|B1|Baseline|Topiramate|Received active topiramate
479506|NCT00802412|P2|Participant Flow|Placebo|"90 participants, will receive matching placebo~Placebo: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design."
479507|NCT00802412|P1|Participant Flow|Topiramate|"The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.~Topiramate: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days)."
479508|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
479509|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
479510|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
479511|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
479512|NCT00802412|E2|Reported Event|Placebo|
479513|NCT00802412|E1|Reported Event|Topiramate|
479514|NCT00802360|B5|Baseline|Total|Total of all reporting groups
479515|NCT00802360|B4|Baseline|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479608|NCT00802100|E1|Reported Event|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
479609|NCT00802074|B7|Baseline|Total|Total of all reporting groups
479762|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
479516|NCT00802360|B3|Baseline|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479517|NCT00802360|B2|Baseline|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479518|NCT00802360|B1|Baseline|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479519|NCT00802360|P4|Participant Flow|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479520|NCT00802360|P3|Participant Flow|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479521|NCT00802360|P2|Participant Flow|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479522|NCT00802360|P1|Participant Flow|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479523|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479524|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479525|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479526|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479527|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479528|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479529|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479610|NCT00802074|B6|Baseline|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479763|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
479530|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479531|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479532|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479533|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479534|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479535|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479536|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479537|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479538|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479539|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479540|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479541|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479542|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479543|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479611|NCT00802074|B5|Baseline|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479764|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
479544|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479545|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479546|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479547|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479548|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479549|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479550|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479551|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479552|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479553|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479554|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479555|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479556|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
479557|NCT00802360|E4|Reported Event|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479558|NCT00802360|E3|Reported Event|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479612|NCT00802074|B4|Baseline|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479559|NCT00802360|E2|Reported Event|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479560|NCT00802360|E1|Reported Event|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
479561|NCT00802204|B3|Baseline|Total|Total of all reporting groups
479562|NCT00802204|B2|Baseline|Obese|
479563|NCT00802204|B1|Baseline|Lean|
479564|NCT00802204|P2|Participant Flow|Obese|BMI>/=30kg/m2
479565|NCT00802204|P1|Participant Flow|Lean|BMI<~25kg/m2
479566|NCT00802204|O2|Outcome|Obese|
479567|NCT00802204|O1|Outcome|Lean|
479568|NCT00802204|O3|Outcome|Obese Post-diet|
479569|NCT00802204|O2|Outcome|Obese Baseline|
479570|NCT00802204|O1|Outcome|Lean Baseline|
479571|NCT00802204|O3|Outcome|Obese Post-diet|
479572|NCT00802204|O2|Outcome|Obese Baseline|
479573|NCT00802204|O1|Outcome|Lean Baseline|
479574|NCT00802204|O3|Outcome|Obese Post-diet|
479575|NCT00802204|O2|Outcome|Obese Baseline|
479576|NCT00802204|O1|Outcome|Lean Baseline|
479577|NCT00802204|O3|Outcome|Obese Post-diet|
479578|NCT00802204|O2|Outcome|Obese Baseline|
479579|NCT00802204|O1|Outcome|Lean Baseline|
479580|NCT00802204|O3|Outcome|Obese Post-diet|
479581|NCT00802204|O2|Outcome|Obese Baseline|
479582|NCT00802204|O1|Outcome|Lean Baseline|
479583|NCT00802204|O3|Outcome|Obese Post-diet|
479584|NCT00802204|O2|Outcome|Obese Baseline|
479585|NCT00802204|O1|Outcome|Lean Baseline|
479586|NCT00802204|E2|Reported Event|Obese|
479587|NCT00802204|E1|Reported Event|Lean|
479588|NCT00802178|B1|Baseline|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
479589|NCT00802178|P1|Participant Flow|Mirapexin® (Pramipexole)|"The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics.~mode of administration (admin.): Tablets for oral use"
479590|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
479591|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
479592|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
479593|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
479594|NCT00802178|E1|Reported Event|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
479595|NCT00802100|B4|Baseline|Total|Total of all reporting groups
479596|NCT00802100|B3|Baseline|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
479597|NCT00802100|B2|Baseline|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
479598|NCT00802100|B1|Baseline|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
479599|NCT00802100|P3|Participant Flow|Aripiprazole|"Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.~Aripiprazole dose 10-30 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
479600|NCT00802100|P2|Participant Flow|Perphenazine|"Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.~Perphenazine dose 8-24 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
479601|NCT00802100|P1|Participant Flow|Olanzapine|"Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.~Olanzapine dose 10-30 mg/day Metformin dose 850-2550 mg/day"
479602|NCT00802100|O3|Outcome|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
479603|NCT00802100|O2|Outcome|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
479604|NCT00802100|O1|Outcome|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
479749|NCT00801138|P2|Participant Flow|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
479613|NCT00802074|B3|Baseline|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479614|NCT00802074|B2|Baseline|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479615|NCT00802074|B1|Baseline|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479616|NCT00802074|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
479617|NCT00802074|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
479618|NCT00802074|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
479619|NCT00802074|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
479620|NCT00802074|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
479621|NCT00802074|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
479622|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
479623|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
479624|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
479625|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
479626|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
479627|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
479628|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
479629|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
479630|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
479631|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
479632|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
479633|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
479634|NCT00802074|O6|Outcome|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479635|NCT00802074|O5|Outcome|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479636|NCT00802074|O4|Outcome|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479750|NCT00801138|P1|Participant Flow|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
479637|NCT00802074|O3|Outcome|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479638|NCT00802074|O2|Outcome|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479639|NCT00802074|O1|Outcome|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
479640|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
479641|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
479642|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
479643|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
479644|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
479645|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
479646|NCT00802074|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
479647|NCT00802074|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
479648|NCT00802074|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
479649|NCT00802074|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
479650|NCT00802074|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
479651|NCT00802074|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
479652|NCT00801983|B3|Baseline|Total|Total of all reporting groups
479653|NCT00801983|B2|Baseline|Group B|Subject receives alternative keyboard first (0-6 months) and typical keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
479654|NCT00801983|B1|Baseline|Group A|Subject receives typical keyboard first (0-6 months) and alternative keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
479655|NCT00801983|P2|Participant Flow|Group B (Alternative/Typical)|Subject receives alternate keyboard for 5-6 months first and typical keyboard second for 5-6 months (total 12 months in study
479656|NCT00801983|P1|Participant Flow|Group A (Typical/Alternative)|Subject receives typical keyboard for 5-6 months first and alternative keyboard second for 5-6 months (total 12 months in study
479657|NCT00801983|O2|Outcome|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
479658|NCT00801983|O1|Outcome|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
479659|NCT00801983|E2|Reported Event|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
479660|NCT00801983|E1|Reported Event|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
479661|NCT00801892|B3|Baseline|Total|Total of all reporting groups
479662|NCT00801892|B2|Baseline|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479663|NCT00801892|B1|Baseline|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479664|NCT00801892|P2|Participant Flow|2=Sham-CPAP Then Active CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP originally; they were then allowed to cross over to the active CPAP after the main period~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479665|NCT00801892|P1|Participant Flow|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479751|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
482337|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
479666|NCT00801892|O2|Outcome|2 Subjects Treated With Sham-CPAP|"Sham Continuous Positive Airway Pressure treatment (sham-CPAP)~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479667|NCT00801892|O1|Outcome|1 Subjects Treated With CPAP|"Continuous Positive Airway Pressure treatment (CPAP)~Continuous Positive Airway Pressure (CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479668|NCT00801892|O2|Outcome|2 Subjects Treated With Sham-CPAP|"Sham Continuous Positive Airway Pressure treatment (sham-CPAP)~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479669|NCT00801892|O1|Outcome|1 Subjects Treated With CPAP|"Continuous Positive Airway Pressure treatment (CPAP)~Continuous Positive Airway Pressure (CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479670|NCT00801892|O2|Outcome|2 Subjects Treated With Sham-CPAP|"Sham Continuous Positive Airway Pressure treatment (sham-CPAP)~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479671|NCT00801892|O1|Outcome|1 Subjects Treated With CPAP|"Continuous Positive Airway Pressure treatment (CPAP)~Continuous Positive Airway Pressure (CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479672|NCT00801892|O2|Outcome|2 Subjects Treated With Sham-CPAP|"Sham Continuous Positive Airway Pressure treatment (sham-CPAP)~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479673|NCT00801892|O1|Outcome|1 Subjects Treated With CPAP|"Continuous Positive Airway Pressure treatment (CPAP)~Continuous Positive Airway Pressure (CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479674|NCT00801892|O2|Outcome|2 Subjects Treated With Sham-CPAP|"Sham Continuous Positive Airway Pressure treatment (sham-CPAP)~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479675|NCT00801892|O1|Outcome|1 Subjects Treated With CPAP|"Continuous Positive Airway Pressure treatment (CPAP)~Continuous Positive Airway Pressure (CPAP): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas)."
479676|NCT00801892|O2|Outcome|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479677|NCT00801892|O1|Outcome|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479678|NCT00801892|E2|Reported Event|2 = Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479679|NCT00801892|E1|Reported Event|1 Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
479680|NCT00801827|B1|Baseline|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
479681|NCT00801827|P1|Participant Flow|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
479682|NCT00801827|O1|Outcome|F-18 (Fallypride)|Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
479683|NCT00801827|E1|Reported Event|F-18 (Fallypride)|"Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.~F-18 (fallypride): Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation."
479684|NCT00801801|B1|Baseline|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
479685|NCT00801801|P1|Participant Flow|Metronomic Taxotere and Nexavar|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.~Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated after every 8 weeks. Treatment with metronomic chemotherapy and sorafenib will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with sorafenib will then continue until disease progression, intolerable toxicity or withdrawal of consent."
479686|NCT00801801|O1|Outcome|Metronomic Docetaxel + Sorafenib|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.~Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle."
479752|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
480298|NCT00799487|E1|Reported Event|Placebo|Placebo was received during the lab school day
479687|NCT00801801|O1|Outcome|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
479688|NCT00801801|E1|Reported Event|Metronomic Taxotere and Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
479689|NCT00801684|B1|Baseline|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
479690|NCT00801684|P1|Participant Flow|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
479691|NCT00801684|O4|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479692|NCT00801684|O3|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
479693|NCT00801684|O2|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479694|NCT00801684|O1|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
479695|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
479696|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
479697|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
479698|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479699|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479700|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
479753|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
479701|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
479702|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
479703|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479704|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479705|NCT00801684|E6|Reported Event|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
479706|NCT00801684|E5|Reported Event|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479707|NCT00801684|E4|Reported Event|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
479708|NCT00801684|E3|Reported Event|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
479709|NCT00801684|E2|Reported Event|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
479710|NCT00801684|E1|Reported Event|Overall Study|
479711|NCT00801632|B1|Baseline|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479712|NCT00801632|P1|Participant Flow|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479754|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
479755|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
479713|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479714|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479715|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479716|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479717|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479718|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479719|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479756|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
479757|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
479758|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
479759|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
479720|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479721|NCT00801632|E1|Reported Event|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
479722|NCT00801242|B1|Baseline|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479723|NCT00801242|P1|Participant Flow|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479724|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479725|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479726|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479727|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479728|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479729|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479730|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479731|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
479732|NCT00801242|E1|Reported Event|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
479733|NCT00801229|B3|Baseline|Total|Total of all reporting groups
479734|NCT00801229|B2|Baseline|Placebo|
479735|NCT00801229|B1|Baseline|Vyvanse|
479736|NCT00801229|P2|Participant Flow|Placebo|
479737|NCT00801229|P1|Participant Flow|Vyvanse|
479738|NCT00801229|O2|Outcome|Placebo|
479739|NCT00801229|O1|Outcome|Vyvanse|
479740|NCT00801229|E2|Reported Event|Placebo|
479741|NCT00801229|E1|Reported Event|Vyvanse|
479742|NCT00801138|B5|Baseline|Total|Total of all reporting groups
479743|NCT00801138|B4|Baseline|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
479744|NCT00801138|B3|Baseline|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
479745|NCT00801138|B2|Baseline|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
479746|NCT00801138|B1|Baseline|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
479747|NCT00801138|P4|Participant Flow|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
479748|NCT00801138|P3|Participant Flow|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
479765|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
479766|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
479767|NCT00801138|E4|Reported Event|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
479768|NCT00801138|E3|Reported Event|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
479769|NCT00801138|E2|Reported Event|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
479770|NCT00801138|E1|Reported Event|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
479771|NCT00801099|B1|Baseline|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
479772|NCT00801099|P1|Participant Flow|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
479773|NCT00801099|O1|Outcome|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
479774|NCT00801099|E1|Reported Event|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
479775|NCT00800982|B3|Baseline|Total|Total of all reporting groups
479776|NCT00800982|B2|Baseline|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
479777|NCT00800982|B1|Baseline|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
479778|NCT00800982|P2|Participant Flow|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. Narrow Band Ultraviolet B therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff."
479779|NCT00800982|P1|Participant Flow|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No Ultraviolet B will be given. Sham Ultraviolet B will not be used because the subjects are not blinded because they often know they are receiving sham Ultraviolet B due to differences in light intensity and heat.
479780|NCT00800982|O2|Outcome|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
479781|NCT00800982|O1|Outcome|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
479782|NCT00800982|E2|Reported Event|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
479783|NCT00800982|E1|Reported Event|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
479784|NCT00800865|B3|Baseline|Total|Total of all reporting groups
479785|NCT00800865|B2|Baseline|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
479786|NCT00800865|B1|Baseline|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
479787|NCT00800865|P2|Participant Flow|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
479807|NCT00800735|E1|Reported Event|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
479788|NCT00800865|P1|Participant Flow|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
479789|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
479790|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
479791|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
479792|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
479793|NCT00800865|E2|Reported Event|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
479794|NCT00800865|E1|Reported Event|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
479795|NCT00800839|B1|Baseline|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479796|NCT00800839|P1|Participant Flow|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479797|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479798|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479799|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479800|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479801|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479802|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479803|NCT00800839|E1|Reported Event|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
479804|NCT00800735|B1|Baseline|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
479805|NCT00800735|P1|Participant Flow|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
479806|NCT00800735|O1|Outcome|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
479808|NCT00800683|B3|Baseline|Total|Total of all reporting groups
479809|NCT00800683|B2|Baseline|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479811|NCT00800683|P2|Participant Flow|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479812|NCT00800683|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
479813|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479814|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479815|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479816|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479817|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479818|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479819|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479820|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479821|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479822|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479823|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479824|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479825|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479826|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479827|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479828|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479829|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479830|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479831|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479832|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479833|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479834|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479835|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479836|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479837|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479838|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479839|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479840|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479841|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479842|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479843|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479844|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479845|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479846|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479847|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479848|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479849|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479850|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479851|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479852|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479853|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479854|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
479855|NCT00800683|E2|Reported Event|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
479856|NCT00800683|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
479857|NCT00800540|B1|Baseline|Overall|All enrolled
479858|NCT00800540|P2|Participant Flow|COMBIGAN/AZARGA|COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
479859|NCT00800540|P1|Participant Flow|AZARGA/COMBIGAN|AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
479860|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479861|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479862|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479863|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479864|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479865|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479866|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479867|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479868|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479869|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479870|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479871|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479872|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479873|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479874|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479875|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479876|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479877|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479878|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479879|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479880|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479881|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479882|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479883|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479884|NCT00800540|E2|Reported Event|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479885|NCT00800540|E1|Reported Event|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
479886|NCT00800436|B8|Baseline|Total|Total of all reporting groups
479887|NCT00800436|B7|Baseline|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479888|NCT00800436|B6|Baseline|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479889|NCT00800436|B5|Baseline|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479890|NCT00800436|B4|Baseline|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479891|NCT00800436|B3|Baseline|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
479892|NCT00800436|B2|Baseline|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479893|NCT00800436|B1|Baseline|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
479894|NCT00800436|P7|Participant Flow|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479895|NCT00800436|P6|Participant Flow|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479896|NCT00800436|P5|Participant Flow|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479897|NCT00800436|P4|Participant Flow|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479898|NCT00800436|P3|Participant Flow|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg subcutaneously (SC) on Day 1.
479899|NCT00800436|P2|Participant Flow|Part 1: Cohort 2|Female participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479900|NCT00800436|P1|Participant Flow|Part 1: Cohort 1|Healthy male participants received Herceptin 6 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1.
479901|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479902|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479903|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479904|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479905|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
479906|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479907|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
479908|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479909|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479910|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479911|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479912|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
479913|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479914|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
479915|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479916|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479917|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479918|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479919|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
479920|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479921|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
480840|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
479922|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479923|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479924|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479925|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479926|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
479927|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479928|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
479929|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479930|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479931|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479932|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479933|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
479934|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479935|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
479936|NCT00800436|E7|Reported Event|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
479937|NCT00800436|E6|Reported Event|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
479938|NCT00800436|E5|Reported Event|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
479939|NCT00800436|E4|Reported Event|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
479940|NCT00800436|E3|Reported Event|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
479941|NCT00800436|E2|Reported Event|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
479942|NCT00800436|E1|Reported Event|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
479943|NCT00800384|B3|Baseline|Total|Total of all reporting groups
479944|NCT00800384|B2|Baseline|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
479945|NCT00800384|B1|Baseline|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
479946|NCT00800384|P2|Participant Flow|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
479947|NCT00800384|P1|Participant Flow|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
479948|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and ventricular fibrillation (VF) induction was performed followed by shock delivery to test shock efficacy at implant.
479949|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
479950|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
479951|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
479952|NCT00800384|E2|Reported Event|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
479953|NCT00800384|E1|Reported Event|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
479954|NCT00800345|B1|Baseline|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
479955|NCT00800345|P1|Participant Flow|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
479956|NCT00800345|O1|Outcome|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
480018|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480019|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
479957|NCT00800345|O1|Outcome|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
479958|NCT00800345|E1|Reported Event|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
479959|NCT00800254|B3|Baseline|Total|Total of all reporting groups
479960|NCT00800254|B2|Baseline|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479961|NCT00800254|B1|Baseline|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479962|NCT00800254|P2|Participant Flow|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479963|NCT00800254|P1|Participant Flow|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479964|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479965|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479966|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479967|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479968|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479969|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479970|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479971|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479972|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479973|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479974|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479975|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479976|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479977|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479978|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479979|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479980|NCT00800254|E2|Reported Event|Standard Rehabilitation Protocol|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
479981|NCT00800254|E1|Reported Event|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
479982|NCT00800202|B3|Baseline|Total|Total of all reporting groups
479983|NCT00800202|B2|Baseline|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
479984|NCT00800202|B1|Baseline|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479985|NCT00800202|P2|Participant Flow|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib150 milligrams per day (mg/day) administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
479986|NCT00800202|P1|Participant Flow|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 milligrams per square meter (mg/m^2) iv every 3 weeks for 6 cycles and carboplatin Area Under Curve (AUC) 6.0 milligrams per milliliter per minute (mg/mL/min) iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479987|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
482338|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
479988|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479989|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
479990|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479991|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
479992|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479993|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
479994|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479995|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
479996|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479997|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
479998|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
479999|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
480000|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
480001|NCT00800202|E2|Reported Event|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
480002|NCT00800202|E1|Reported Event|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
480003|NCT00799903|B3|Baseline|Total|Total of all reporting groups
480004|NCT00799903|B2|Baseline|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480005|NCT00799903|B1|Baseline|Placebo|Participants were randomized to receive matching placebo once daily.
480006|NCT00799903|P2|Participant Flow|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480007|NCT00799903|P1|Participant Flow|Placebo|Participants were randomized to receive matching placebo once daily.
480008|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480009|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
480010|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480011|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
480012|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480013|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
480014|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480015|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
480016|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480017|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
480020|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480021|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
480022|NCT00799903|O2|Outcome|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480023|NCT00799903|O1|Outcome|Placebo|Participants were randomized to receive matching placebo once daily.
480024|NCT00799903|E2|Reported Event|Darapladib|Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
480025|NCT00799903|E1|Reported Event|Placebo|Participants were randomized to receive matching placebo once daily.
480026|NCT00799825|B1|Baseline|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
480027|NCT00799825|P1|Participant Flow|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
480028|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
480029|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
480030|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
480031|NCT00799825|E1|Reported Event|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
480032|NCT00799773|B3|Baseline|Total|Total of all reporting groups
480033|NCT00799773|B2|Baseline|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480034|NCT00799773|B1|Baseline|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480035|NCT00799773|P2|Participant Flow|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480036|NCT00799773|P1|Participant Flow|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480037|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480038|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480039|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480040|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480041|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480042|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480043|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480044|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480045|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480046|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480047|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480048|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480049|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480050|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480051|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480052|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480053|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480054|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480055|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480056|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480057|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480058|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480059|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480060|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480061|NCT00799773|E2|Reported Event|Standard of Care|Participants will receive plasma exchange and corticosteroids.
480062|NCT00799773|E1|Reported Event|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
480063|NCT00799708|B4|Baseline|Total|Total of all reporting groups
480064|NCT00799708|B3|Baseline|Placebo|Placebo capsule once daily for 7 days.
480068|NCT00799708|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
480069|NCT00799708|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
480070|NCT00799708|O2|Outcome|Placebo|
480071|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|
480072|NCT00799708|O3|Outcome|Placebo|Placebo capsule once daily for 7 days.
480073|NCT00799708|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
480074|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
480075|NCT00799708|E3|Reported Event|Placebo|Placebo capsule once daily for 7 days.
480076|NCT00799708|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
480077|NCT00799708|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
480078|NCT00799643|B3|Baseline|Total|Total of all reporting groups
480079|NCT00799643|B2|Baseline|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
480080|NCT00799643|B1|Baseline|Placebo|Placebo for salsalate, orally, divided dosing
480081|NCT00799643|P2|Participant Flow|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
480082|NCT00799643|P1|Participant Flow|Placebo|Placebo for salsalate, orally, divided dosing
480083|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
480084|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
480085|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
480086|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
480087|NCT00799643|E2|Reported Event|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
480088|NCT00799643|E1|Reported Event|Placebo|Placebo for salsalate, orally, divided dosing
480089|NCT00799617|B3|Baseline|Total|Total of all reporting groups
480090|NCT00799617|B2|Baseline|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480091|NCT00799617|B1|Baseline|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480092|NCT00799617|P2|Participant Flow|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480093|NCT00799617|P1|Participant Flow|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480094|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480095|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480096|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480097|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480098|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480099|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480100|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480101|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480102|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480103|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480104|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480105|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480106|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480107|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480108|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480109|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480110|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480111|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480112|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480113|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480114|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480115|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480241|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
482339|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
480116|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480117|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480118|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480119|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480120|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480121|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480122|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480123|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480124|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480125|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480126|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480127|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480128|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480129|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480130|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480146|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480131|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480132|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480133|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480134|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480135|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480136|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480137|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480138|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480139|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480140|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480141|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480142|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480143|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480144|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480145|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480238|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
482340|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
480147|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480148|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480149|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480150|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480151|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480152|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480153|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480154|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480155|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480156|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480157|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480158|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480159|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480160|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480161|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480239|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
482341|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
480162|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480163|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480164|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480165|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480166|NCT00799617|O2|Outcome|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480167|NCT00799617|O1|Outcome|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480168|NCT00799617|E2|Reported Event|Placebo Gel|"Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.~Placebo: Testosterone levels will be measured at regular intervals."
480169|NCT00799617|E1|Reported Event|AndroGel® (Testosterone Gel)|"AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.~AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range."
480170|NCT00799604|B4|Baseline|Total|Total of all reporting groups
480171|NCT00799604|B3|Baseline|Cohort 3: Clevidipine 125 μg ( mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480172|NCT00799604|B2|Baseline|Cohort 2: Clevidipine 500 μg (1.0 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which Clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480173|NCT00799604|B1|Baseline|Cohort 1: Clevidipine 250 μg (0.5 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480174|NCT00799604|P3|Participant Flow|Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Three participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 received a Bolus 2 dose of 125 μg during Treatment Period 2 in this cohort.
480175|NCT00799604|P2|Participant Flow|Planned Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Six participants who received a Bolus 1 dose of 500 μg and six participants who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 500 μg during Treatment Period 2 in this cohort.
480176|NCT00799604|P1|Participant Flow|Planned Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Five participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 and one participant who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 250 μg during Treatment Period 2 in this cohort.
480177|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
482342|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
480178|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480179|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480180|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480181|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480182|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480183|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480184|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480185|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480186|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480187|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480188|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480189|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480190|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480191|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480192|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480193|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480194|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480195|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480196|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480197|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
480198|NCT00799604|E1|Reported Event|All Participants Across All Cohorts and Treatment Periods|Study participants were sequentially assigned one of three cohorts to receive either a 250 μg, 500 μg or 125 μg bolus dose of clevidipine during Treatment Period 1 prior to induction of general anesthesia (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds). At the discretion of the investigator, a second bolus could be administered during Treatment Period 2 after induction of general anesthesia (Bolus 2 - with anesthesia) at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.
480199|NCT00799591|B1|Baseline|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480200|NCT00799591|P1|Participant Flow|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480201|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480240|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480202|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480203|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480204|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480205|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480206|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480207|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480208|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480209|NCT00799591|E1|Reported Event|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
480210|NCT00799578|B1|Baseline|Cystagon-EC|
480211|NCT00799578|P1|Participant Flow|Cystagon-EC|
480212|NCT00799578|O1|Outcome|Number of Improved Subjects|
480213|NCT00799578|E1|Reported Event|Number of Improved Subjects|
480214|NCT00799487|B4|Baseline|Total|Total of all reporting groups
480215|NCT00799487|B3|Baseline|Concerta/Placebo|Children randomized to receive Concerta at lab school day 1 and Placebo at lab school day 2
480216|NCT00799487|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and Concerta lab school day 2
480217|NCT00799487|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
480218|NCT00799487|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
480219|NCT00799487|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
480220|NCT00799487|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
480221|NCT00799487|O3|Outcome|Concerta|Chilfdren randomized to receive Concerta at lab school day 1 or lab school day 2
480222|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480223|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480224|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480225|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480226|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480227|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480228|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480229|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480230|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480231|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480232|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480233|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480234|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480235|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480236|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480237|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480242|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480243|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480244|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480245|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480246|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480247|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480248|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480249|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480250|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480251|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480252|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480253|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480254|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480255|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480256|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480257|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480258|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480259|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480260|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480261|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480262|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480263|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480264|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480265|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480266|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480267|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480268|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480269|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480270|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480271|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480272|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480273|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or at lab school day 2
480274|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480275|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480276|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480277|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480278|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480279|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480280|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480281|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480282|NCT00799487|O2|Outcome|Placebo|Chidren randomized to receive Placebo at lab school day 1 or lab school day 2
480283|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480284|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480285|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480286|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480287|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480288|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480289|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480290|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480291|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480292|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480293|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480294|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480295|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480296|NCT00799487|E3|Reported Event|Open Label|dose adjustment period and double blind period other than lab school day
480297|NCT00799487|E2|Reported Event|Concerta|Concerta was received during the lab school day
480299|NCT00799474|B1|Baseline|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
480300|NCT00799474|P1|Participant Flow|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
480301|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
480302|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
480303|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
480304|NCT00799474|E1|Reported Event|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
480305|NCT00799435|B3|Baseline|Total|Total of all reporting groups
480306|NCT00799435|B2|Baseline|Exenatide|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
480307|NCT00799435|B1|Baseline|Usual Care|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
480308|NCT00799435|P2|Participant Flow|Exenatide Group|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
480309|NCT00799435|P1|Participant Flow|Control Group|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
480310|NCT00799435|O2|Outcome|Exenatide|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
480311|NCT00799435|O1|Outcome|Usual Care|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
480312|NCT00799435|E2|Reported Event|Exenatide|"Participants will receive exenatide for 12 weeks.~Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks"
480313|NCT00799435|E1|Reported Event|Standard Care|Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
480314|NCT00799422|B1|Baseline|Overall|Baseline characteristics are presented for all participants completing all three treatment sequences.
480315|NCT00799422|P6|Participant Flow|Clear Care / Complete / ReNu|Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
480316|NCT00799422|P5|Participant Flow|Complete / ReNu / Clear Care|Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each
480317|NCT00799422|P4|Participant Flow|ReNu / Clear Care / Complete|ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each
480318|NCT00799422|P3|Participant Flow|Clear Care / ReNu / Complete|Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each
480319|NCT00799422|P2|Participant Flow|Complete / Clear Care / ReNu|Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each
480320|NCT00799422|P1|Participant Flow|ReNu / Complete / Clear Care|ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each
480321|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
480322|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
480323|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
480324|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
480325|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
480326|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
480327|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
480328|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
480329|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
480330|NCT00799422|E3|Reported Event|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
480331|NCT00799422|E2|Reported Event|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
480332|NCT00799422|E1|Reported Event|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
480333|NCT00799409|B4|Baseline|Total|Total of all reporting groups
480334|NCT00799409|B3|Baseline|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
480335|NCT00799409|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
480336|NCT00799409|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
480337|NCT00799409|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
482343|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
480338|NCT00799409|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
480339|NCT00799409|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
480340|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480341|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480342|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480343|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480344|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480345|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480346|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480347|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480348|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480349|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480350|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480351|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480352|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480353|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480354|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480355|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480356|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480357|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480358|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480359|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480360|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480361|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480362|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480363|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480364|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480365|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480366|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480367|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480368|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480369|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480370|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480371|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480372|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480373|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480374|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480375|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480376|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480377|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480378|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480379|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480380|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480381|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480382|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480383|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480384|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480385|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480386|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480387|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480388|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480389|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480390|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480391|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480392|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480393|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480394|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480395|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480396|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480397|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480398|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480399|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480400|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480401|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480402|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480403|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480404|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480405|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480406|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480407|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480408|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480409|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480410|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480411|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480412|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
480413|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
480414|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
480415|NCT00799409|E3|Reported Event|Open Label/Non-Lab Day CONCERTA|Dose adjustment period and double blind period other than lab school day
480416|NCT00799409|E2|Reported Event|Concerta|Concerta was received during the lab school day
480417|NCT00799409|E1|Reported Event|Placebo|Placebo was received during the lab school day
480418|NCT00799396|B1|Baseline|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
480419|NCT00799396|P1|Participant Flow|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
480420|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment~PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation~PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
480421|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment~PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation~PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
480422|NCT00799396|E1|Reported Event|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
480423|NCT00799383|B3|Baseline|Total|Total of all reporting groups
480424|NCT00799383|B2|Baseline|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480425|NCT00799383|B1|Baseline|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480426|NCT00799383|P2|Participant Flow|Placebo|Placebo administered in similarly looking capsules.
480427|NCT00799383|P1|Participant Flow|Calcium+VitD|Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
480428|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480429|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
482344|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
480430|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480431|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480432|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480433|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480434|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480435|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480436|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480437|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480438|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480439|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480440|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480441|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480442|NCT00799383|O2|Outcome|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480443|NCT00799383|O1|Outcome|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480444|NCT00799383|E2|Reported Event|Placebo|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480445|NCT00799383|E1|Reported Event|Calcium+VitD|"Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.~I labelled the intervention type as drug, even though dietary supplement would be more appropriate as the system sent the following error message:~ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic."
480446|NCT00799292|B3|Baseline|Total|Total of all reporting groups
480447|NCT00799292|B2|Baseline|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
480448|NCT00799292|B1|Baseline|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
480449|NCT00799292|P2|Participant Flow|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
480450|NCT00799292|P1|Participant Flow|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
480451|NCT00799292|O2|Outcome|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
480452|NCT00799292|O1|Outcome|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
480453|NCT00799227|B1|Baseline|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
480454|NCT00799227|P1|Participant Flow|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
480455|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
480456|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
480457|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
480458|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
480459|NCT00799227|E1|Reported Event|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
480460|NCT00798967|B3|Baseline|Total|Total of all reporting groups
480461|NCT00798967|B2|Baseline|Placebo|Matching sc dose of placebo to teduglutide
480462|NCT00798967|B1|Baseline|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
480463|NCT00798967|P2|Participant Flow|Placebo|Matching sc dose of placebo to teduglutide
480464|NCT00798967|P1|Participant Flow|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
480465|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
480466|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day sc dose of teduglutide
480467|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
480468|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
480469|NCT00798967|E2|Reported Event|Placebo|Matching sc dose of placebo to teduglutide
480470|NCT00798967|E1|Reported Event|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
480471|NCT00798889|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
480472|NCT00798889|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
480473|NCT00798889|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
480474|NCT00798889|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
480475|NCT00798759|B3|Baseline|Total|Total of all reporting groups
480476|NCT00798759|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
480477|NCT00798759|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
480478|NCT00798759|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
480479|NCT00798759|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
480480|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
480481|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
480482|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
480483|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
480484|NCT00798759|E2|Reported Event|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
480485|NCT00798759|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
480486|NCT00798720|B1|Baseline|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
480487|NCT00798720|P1|Participant Flow|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
480488|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
480489|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
480490|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
480491|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
480585|NCT00798577|B2|Baseline|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480492|NCT00798720|E1|Reported Event|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
480493|NCT00798707|B4|Baseline|Total|Total of all reporting groups
480494|NCT00798707|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480495|NCT00798707|B2|Baseline|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480496|NCT00798707|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480497|NCT00798707|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480498|NCT00798707|P2|Participant Flow|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480499|NCT00798707|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480500|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480501|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480502|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480503|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480504|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480505|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480506|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480507|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480508|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480509|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480510|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480511|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480512|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480513|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480514|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480515|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480516|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480517|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480518|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480519|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480520|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480521|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480522|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480523|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480524|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480525|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480526|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480527|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480528|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480529|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480530|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480531|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480532|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480533|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480534|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480535|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480536|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480537|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480538|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480539|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480540|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480541|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480542|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480543|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480544|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480545|NCT00798707|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
480546|NCT00798707|E2|Reported Event|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
480547|NCT00798707|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
480548|NCT00798655|B1|Baseline|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
480549|NCT00798655|P1|Participant Flow|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
480550|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
480551|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
480552|NCT00798655|E1|Reported Event|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
480553|NCT00798603|B1|Baseline|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480554|NCT00798603|P1|Participant Flow|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480555|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480556|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480557|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480558|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480559|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480560|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480561|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480562|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480563|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480564|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480565|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480566|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480567|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480568|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480569|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480570|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480571|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480572|NCT00798603|E1|Reported Event|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
480573|NCT00798590|B3|Baseline|Total|Total of all reporting groups
480574|NCT00798590|B2|Baseline|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
480575|NCT00798590|B1|Baseline|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
480576|NCT00798590|P2|Participant Flow|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
480577|NCT00798590|P1|Participant Flow|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
480578|NCT00798590|O2|Outcome|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
480579|NCT00798590|O1|Outcome|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
480580|NCT00798590|O2|Outcome|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
480581|NCT00798590|O1|Outcome|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
480582|NCT00798590|E2|Reported Event|Saline|Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
480583|NCT00798590|E1|Reported Event|GLP-1|Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
480584|NCT00798577|B3|Baseline|Total|Total of all reporting groups
480586|NCT00798577|B1|Baseline|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480587|NCT00798577|P2|Participant Flow|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480588|NCT00798577|P1|Participant Flow|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480589|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480590|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480591|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480592|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480593|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480594|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480595|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480596|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480597|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480598|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480599|NCT00798577|E2|Reported Event|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
480600|NCT00798577|E1|Reported Event|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
480601|NCT00798486|B1|Baseline|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
480602|NCT00798486|P1|Participant Flow|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
480603|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
480604|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
480605|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
480606|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
480607|NCT00798486|E1|Reported Event|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
480608|NCT00798434|B3|Baseline|Total|Total of all reporting groups
480609|NCT00798434|B2|Baseline|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480610|NCT00798434|B1|Baseline|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480611|NCT00798434|P2|Participant Flow|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480612|NCT00798434|P1|Participant Flow|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 milligrams (mg) once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480613|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480614|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480615|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480616|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480617|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480618|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480619|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480674|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480620|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480621|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480622|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480623|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480624|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480625|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480626|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480627|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480628|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480629|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480630|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480631|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480632|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480633|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480634|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480635|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480636|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480637|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480638|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480639|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480640|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480641|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480642|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480643|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480774|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
486693|NCT00786188|B3|Baseline|Total|Total of all reporting groups
480644|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480645|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480646|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480647|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480648|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480649|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480650|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480651|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480652|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480653|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480654|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480655|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480656|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480657|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480658|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480659|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480660|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480661|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480662|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480663|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480664|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480665|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480666|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480667|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480668|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480669|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480670|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480671|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480672|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480673|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480675|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480676|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480677|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480678|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480679|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480680|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480681|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480682|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480683|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480684|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480685|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
480686|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
480687|NCT00798434|E4|Reported Event|Placebo/Fesoterodine Open-label|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). SAEs and non-serious AEs reported for these participants only during the open-label phase.
480688|NCT00798434|E3|Reported Event|Festerodine/Fesoterodine Open-Label|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). Serious adverse events (SAEs) and non-serious adverse events (AEs) reported reported for these participants only during the open-label phase.
480689|NCT00798434|E2|Reported Event|Fesoterodine Double-Blind|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded)
480690|NCT00798434|E1|Reported Event|Placebo Double-Blind|Participants received matched placebo once daily from baseline to Week 12 (double-blinded)
480691|NCT00798369|B7|Baseline|Total|Total of all reporting groups
480692|NCT00798369|B6|Baseline|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480693|NCT00798369|B5|Baseline|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480694|NCT00798369|B4|Baseline|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480695|NCT00798369|B3|Baseline|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480696|NCT00798369|B2|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480697|NCT00798369|B1|Baseline|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480698|NCT00798369|P6|Participant Flow|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480699|NCT00798369|P5|Participant Flow|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480700|NCT00798369|P4|Participant Flow|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480701|NCT00798369|P3|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480702|NCT00798369|P2|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480703|NCT00798369|P1|Participant Flow|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480704|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480705|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480706|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480707|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480708|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480709|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480710|NCT00798369|O1|Outcome|Linear Model|The linear model was the best-fitting model out of the 4 selected models (Emax, Logistic, Linear in Log-dose, Linear)with lowest Akaike Information Criterion (AIC).
480711|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480712|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480713|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480714|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480715|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480716|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480717|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480718|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480719|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480777|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480720|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480721|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480722|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480723|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480724|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480725|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480726|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480727|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480728|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480729|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480730|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480731|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480732|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480733|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480734|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480735|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480736|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480737|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480775|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480776|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480738|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480739|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480740|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480741|NCT00798369|E6|Reported Event|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
480742|NCT00798369|E5|Reported Event|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480743|NCT00798369|E4|Reported Event|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480744|NCT00798369|E3|Reported Event|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480745|NCT00798369|E2|Reported Event|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480746|NCT00798369|E1|Reported Event|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
480747|NCT00798317|B3|Baseline|Total|Total of all reporting groups
480748|NCT00798317|B2|Baseline|Placebo|Intravitreal injection of placebo
480749|NCT00798317|B1|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
480750|NCT00798317|P2|Participant Flow|Placebo|Intravitreal injection of placebo
480751|NCT00798317|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
480752|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
480753|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
480754|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
480755|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
480756|NCT00798317|E2|Reported Event|Placebo|Intravitreal injection of placebo
480757|NCT00798317|E1|Reported Event|Ocriplasmin 125ug|125ug ocriplasmin intravitreal injection
480758|NCT00798304|B4|Baseline|Total|Total of all reporting groups
480759|NCT00798304|B3|Baseline|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480760|NCT00798304|B2|Baseline|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480761|NCT00798304|B1|Baseline|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480762|NCT00798304|P3|Participant Flow|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480763|NCT00798304|P2|Participant Flow|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480764|NCT00798304|P1|Participant Flow|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480765|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480766|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480767|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480768|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480769|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480770|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480771|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480772|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480773|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480839|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480778|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480779|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480780|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480781|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480782|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480783|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480784|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480785|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480786|NCT00798304|E3|Reported Event|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
480787|NCT00798304|E2|Reported Event|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
480788|NCT00798304|E1|Reported Event|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
480789|NCT00798161|B8|Baseline|Total|Total of all reporting groups
480790|NCT00798161|B7|Baseline|L2.5+M1000BID (Open Label)|Open label set: Linagliptin 2.5mg + Metformin 1000mg BID
480791|NCT00798161|B6|Baseline|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480792|NCT00798161|B5|Baseline|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480793|NCT00798161|B4|Baseline|Lina5|Patients treated with Linagliptin 5mg OD
480794|NCT00798161|B3|Baseline|M1000BID|Patients treated with Metformin 1000mg BID
480795|NCT00798161|B2|Baseline|M500BID|Patients treated with Metformin 500mg BID
480796|NCT00798161|B1|Baseline|Placebo|Patients treated with matching placebo
480797|NCT00798161|P7|Participant Flow|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
480798|NCT00798161|P6|Participant Flow|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
480799|NCT00798161|P5|Participant Flow|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
480800|NCT00798161|P4|Participant Flow|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
480801|NCT00798161|P3|Participant Flow|M1000 BID|Patients treated with Metformin 1000 mg BID
480802|NCT00798161|P2|Participant Flow|M500 Twice Daily (BID)|Patients treated with Metformin 500 mg BID
480803|NCT00798161|P1|Participant Flow|Placebo|Patients treated with matching placebo
480804|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480805|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480806|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480807|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480808|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480809|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480810|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
480811|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
480812|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480813|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480814|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480815|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480816|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480817|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480818|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480819|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480820|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480821|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480822|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480823|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480824|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480825|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480826|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480827|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480828|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480829|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480830|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480831|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480832|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480833|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480834|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480835|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480836|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480837|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480838|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480841|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480842|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480843|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480844|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480845|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480846|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480847|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480848|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480849|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480850|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480851|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480852|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480853|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480854|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480855|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480856|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480857|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480858|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480859|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480860|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480861|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480862|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480863|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480864|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480865|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480866|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480867|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480868|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480869|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480870|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480871|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480872|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480873|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480874|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480875|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480876|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480877|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480878|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480879|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480880|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480881|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480882|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480883|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480884|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480885|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480886|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480887|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480888|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480889|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480890|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480891|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480892|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480893|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480894|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480895|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480896|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
480897|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
480898|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
480899|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
480900|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
480901|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
480902|NCT00798161|E7|Reported Event|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
480903|NCT00798161|E6|Reported Event|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
480904|NCT00798161|E5|Reported Event|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)
480905|NCT00798161|E4|Reported Event|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
480906|NCT00798161|E3|Reported Event|M1000 BID|Patients treated with Metformin 1000 mg bis in die (BID)
480907|NCT00798161|E2|Reported Event|M500 BID|Patients treated with Metformin 500 mg BID
480908|NCT00798161|E1|Reported Event|Placebo|Patients treated with matching placebo
481823|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
480909|NCT00798135|B1|Baseline|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
480910|NCT00798135|P1|Participant Flow|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
480911|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
480912|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
480913|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
480914|NCT00798135|E1|Reported Event|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
480915|NCT00798096|B1|Baseline|Overall Study|1-fostamatinib 200mg, BID, Oral
480916|NCT00798096|P1|Participant Flow|Overall Study|1-fostamatinib 200mg, BID, Oral
480917|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
480918|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
480919|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
480920|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
480921|NCT00798096|E1|Reported Event|Overall Study|1-fostamatinib 200mg, BID, Oral
480922|NCT00798018|B5|Baseline|Total|Total of all reporting groups
480923|NCT00798018|B4|Baseline|Tetracaine|1% tetracaine was used to inflate the cuff
480924|NCT00798018|B3|Baseline|Lidocaine|2% lidiocaine was used to inflate the cuff
480925|NCT00798018|B2|Baseline|Normal Saline|normal saline was used to inflate the cuff
480926|NCT00798018|B1|Baseline|Air Alone|Only air was injected into the cuff, as the routine practice
480927|NCT00798018|P4|Participant Flow|Tetracaine|1% tetracaine was used to inflate the cuff
480928|NCT00798018|P3|Participant Flow|Lidocaine|2% lidiocaine was used to inflate the cuff
480929|NCT00798018|P2|Participant Flow|Normal Saline|normal saline was used to inflate the cuff
480930|NCT00798018|P1|Participant Flow|Air Alone|Only air was injected into the cuff, as the routine practice
480931|NCT00798018|O4|Outcome|Tetracaine|1% tetracaine was used to inflate the cuff
480932|NCT00798018|O3|Outcome|Lidocaine|2% lidiocaine was used to inflate the cuff
480933|NCT00798018|O2|Outcome|Normal Saline|normal saline was used to inflate the cuff
480934|NCT00798018|O1|Outcome|Air Alone|Only air was injected into the cuff, as the routine practice
480935|NCT00798018|E4|Reported Event|Tetracaine|1% tetracaine was used to inflate the cuff
480936|NCT00798018|E3|Reported Event|Lidocaine|2% lidiocaine was used to inflate the cuff
480937|NCT00798018|E2|Reported Event|Normal Saline|normal saline was used to inflate the cuff
480938|NCT00798018|E1|Reported Event|Air Alone|Only air was injected into the cuff, as the routine practice
480939|NCT00797966|B5|Baseline|Total|Total of all reporting groups
480940|NCT00797966|B4|Baseline|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480941|NCT00797966|B3|Baseline|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480942|NCT00797966|B2|Baseline|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
480943|NCT00797966|B1|Baseline|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480944|NCT00797966|P6|Participant Flow|Participants in Phase A+|Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.
480945|NCT00797966|P5|Participant Flow|Participants in Phase A|Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
480946|NCT00797966|P4|Participant Flow|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480947|NCT00797966|P3|Participant Flow|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480948|NCT00797966|P2|Participant Flow|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480949|NCT00797966|P1|Participant Flow|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480950|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480951|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480952|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
480953|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480954|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481060|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
480955|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480956|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480957|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480958|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480959|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480960|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480961|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480962|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480963|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480964|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
480965|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480966|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480967|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480968|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
480969|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480970|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480971|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480972|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480973|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480974|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480975|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480976|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480977|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480978|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480979|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480980|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480981|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480982|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480983|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480984|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480985|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480986|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480987|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480988|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480989|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480990|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
480991|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480992|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480993|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480994|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480995|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480996|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480997|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480998|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
480999|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481000|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481001|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481002|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481003|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481004|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481005|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481006|NCT00797966|E4|Reported Event|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481007|NCT00797966|E3|Reported Event|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481008|NCT00797966|E2|Reported Event|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481009|NCT00797966|E1|Reported Event|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
481010|NCT00797862|B4|Baseline|Total|Total of all reporting groups
481011|NCT00797862|B3|Baseline|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481012|NCT00797862|B2|Baseline|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481013|NCT00797862|B1|Baseline|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481061|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
489592|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
481014|NCT00797862|P3|Participant Flow|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481015|NCT00797862|P2|Participant Flow|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481016|NCT00797862|P1|Participant Flow|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481017|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481018|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481019|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481020|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481021|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481022|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481023|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481024|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481025|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481062|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
481026|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481027|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481028|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481029|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481030|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481031|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481032|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481033|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481034|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481035|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481036|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481037|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481063|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
481038|NCT00797862|E3|Reported Event|Amlodipine|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481039|NCT00797862|E2|Reported Event|Aliskiren|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481040|NCT00797862|E1|Reported Event|Aliskiren + Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
481041|NCT00797823|B4|Baseline|Total|Total of all reporting groups
481042|NCT00797823|B3|Baseline|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
481043|NCT00797823|B2|Baseline|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
481044|NCT00797823|B1|Baseline|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
481045|NCT00797823|P3|Participant Flow|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
481046|NCT00797823|P2|Participant Flow|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
481047|NCT00797823|P1|Participant Flow|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
481048|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
481049|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
481050|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
481051|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
481052|NCT00797823|E3|Reported Event|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
481053|NCT00797823|E2|Reported Event|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
481054|NCT00797823|E1|Reported Event|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
481055|NCT00797797|B3|Baseline|Total|Total of all reporting groups
481056|NCT00797797|B2|Baseline|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
481057|NCT00797797|B1|Baseline|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
481058|NCT00797797|P2|Participant Flow|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
481059|NCT00797797|P1|Participant Flow|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
494831|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
481064|NCT00797797|E2|Reported Event|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
481065|NCT00797797|E1|Reported Event|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
481066|NCT00797732|B3|Baseline|Total|Total of all reporting groups
481067|NCT00797732|B2|Baseline|Sham Acupuncture|TBoth active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481068|NCT00797732|B1|Baseline|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481069|NCT00797732|P3|Participant Flow|Screened Non-Randomized|Participants approached in the screening process but ultimately not randomized.
481070|NCT00797732|P2|Participant Flow|Sham Acupuncture|The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. [Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005; 86:2248-2255]
481071|NCT00797732|P1|Participant Flow|Active Acupuncture|The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5–10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. [Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261]
481072|NCT00797732|O2|Outcome|Sham Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481073|NCT00797732|O1|Outcome|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481074|NCT00797732|O2|Outcome|Sham Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481075|NCT00797732|O1|Outcome|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481076|NCT00797732|O2|Outcome|Sham Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481077|NCT00797732|O1|Outcome|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481078|NCT00797732|O2|Outcome|Sham Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481079|NCT00797732|O1|Outcome|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481080|NCT00797732|E2|Reported Event|Sham Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481081|NCT00797732|E1|Reported Event|Active Acupuncture|Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
481082|NCT00797667|B4|Baseline|Total|Total of all reporting groups
481083|NCT00797667|B3|Baseline|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481084|NCT00797667|B2|Baseline|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481085|NCT00797667|B1|Baseline|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481086|NCT00797667|P3|Participant Flow|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481087|NCT00797667|P2|Participant Flow|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481088|NCT00797667|P1|Participant Flow|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481089|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481090|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481091|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481092|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
494832|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
481093|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481094|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481095|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481096|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481097|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481098|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481099|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481100|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481101|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481102|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481103|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481104|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481105|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481106|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481107|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481108|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481109|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481110|NCT00797667|E3|Reported Event|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481111|NCT00797667|E2|Reported Event|MK-0974 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
481112|NCT00797667|E1|Reported Event|MK-0974 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
481113|NCT00797563|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
481114|NCT00797563|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
481115|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
481116|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
481117|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
481118|NCT00797563|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
481119|NCT00797511|B1|Baseline|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
481120|NCT00797511|P1|Participant Flow|ADACEL POLIO Vaccine Study Group|Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
481121|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
481122|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
481123|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
481124|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
481125|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
481126|NCT00797511|E1|Reported Event|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
481127|NCT00797459|B1|Baseline|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
481128|NCT00797459|P1|Participant Flow|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
481129|NCT00797459|O2|Outcome|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
481130|NCT00797459|O1|Outcome|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
481131|NCT00797459|O2|Outcome|Restylane-L|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
481132|NCT00797459|O1|Outcome|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
481133|NCT00797459|E2|Reported Event|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
481134|NCT00797459|E1|Reported Event|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
481135|NCT00797316|B3|Baseline|Total|Total of all reporting groups
481136|NCT00797316|B2|Baseline|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481137|NCT00797316|B1|Baseline|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481138|NCT00797316|P2|Participant Flow|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481139|NCT00797316|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481140|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481141|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481142|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481143|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481144|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481145|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481146|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481147|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481148|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481149|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481150|NCT00797316|E2|Reported Event|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
481151|NCT00797316|E1|Reported Event|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
481152|NCT00797277|B3|Baseline|Total|Total of all reporting groups
481153|NCT00797277|B2|Baseline|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
481154|NCT00797277|B1|Baseline|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
481155|NCT00797277|P2|Participant Flow|2. IM Haloperidol Plus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
481156|NCT00797277|P1|Participant Flow|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
481157|NCT00797277|O2|Outcome|2. IM Haloperidol Pus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
481158|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
481159|NCT00797277|O2|Outcome|2. IM Haloperidol Plus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
481160|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
481161|NCT00797277|E2|Reported Event|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
481162|NCT00797277|E1|Reported Event|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
481163|NCT00797212|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm
481164|NCT00797212|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
481165|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
481166|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
482331|NCT00795145|O1|Outcome|Cohort 2: Moxifloxacin|Oral administration, positive control, not blinded.
481167|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
481168|NCT00797212|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
481169|NCT00797108|B4|Baseline|Total|Total of all reporting groups
481170|NCT00797108|B3|Baseline|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481171|NCT00797108|B2|Baseline|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481172|NCT00797108|B1|Baseline|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481173|NCT00797108|P3|Participant Flow|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481174|NCT00797108|P2|Participant Flow|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481175|NCT00797108|P1|Participant Flow|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481176|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481177|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481178|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481179|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481180|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481181|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481182|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481183|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481184|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481185|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481186|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481187|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481188|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481189|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481234|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481432|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481190|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481191|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481192|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481193|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481194|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481195|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481196|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481197|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481198|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481199|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481246|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481200|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481201|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481202|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481203|NCT00797108|E3|Reported Event|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481204|NCT00797108|E2|Reported Event|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481205|NCT00797108|E1|Reported Event|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
481206|NCT00796991|B4|Baseline|Total|Total of all reporting groups
481207|NCT00796991|B3|Baseline|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481208|NCT00796991|B2|Baseline|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481209|NCT00796991|B1|Baseline|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481210|NCT00796991|P3|Participant Flow|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481211|NCT00796991|P2|Participant Flow|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481423|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481212|NCT00796991|P1|Participant Flow|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481213|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481214|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481215|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481216|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481217|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481218|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481219|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481220|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481221|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481222|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481258|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481424|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481223|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481224|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481225|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481226|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481227|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481228|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481229|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481230|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481231|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481232|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481233|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481425|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
482332|NCT00795145|O3|Outcome|Cohort 2: Placebo|0.9% Saline
481235|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481236|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481237|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481238|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481239|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481240|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481241|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481242|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481243|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481244|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481245|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481426|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481540|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481247|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481248|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481249|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481250|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481251|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481252|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481253|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481254|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481255|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481256|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481257|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481427|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
482333|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|Zyvox IV Injection
481259|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481260|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481261|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481262|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481263|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481264|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481265|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481266|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481267|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481268|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481269|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481428|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481541|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481270|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481271|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481272|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481273|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481274|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481275|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481276|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481277|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481278|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481279|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481280|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481303|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481429|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
494833|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
481281|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481282|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481283|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481284|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481285|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481286|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481287|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481288|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481289|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481290|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481291|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481333|NCT00796757|B1|Baseline|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481430|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481542|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481292|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481293|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481294|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481295|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481296|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481297|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481298|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481299|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481300|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481301|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481302|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481374|NCT00796705|B5|Baseline|Total|Total of all reporting groups
481431|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481304|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481305|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481306|NCT00796991|E3|Reported Event|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481307|NCT00796991|E2|Reported Event|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481308|NCT00796991|E1|Reported Event|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
481309|NCT00796926|B3|Baseline|Total|Total of all reporting groups
481310|NCT00796926|B2|Baseline|Refresh|Four times a day for 6 weeks in each eye
481311|NCT00796926|B1|Baseline|Systane Ultra|four times a day for six weeks in each eye
481312|NCT00796926|P2|Participant Flow|Refresh|Four times a day for 6 weeks in each eye
481313|NCT00796926|P1|Participant Flow|Systane Ultra|four times a day for six weeks in each eye
481314|NCT00796926|O2|Outcome|Refresh|Four times a day for 6 weeks in each eye
481315|NCT00796926|O1|Outcome|Systane Ultra|four times a day for six weeks in each eye
481316|NCT00796926|E2|Reported Event|Refresh|Four times a day for 6 weeks in each eye
481317|NCT00796926|E1|Reported Event|Systane Ultra|four times a day for six weeks in each eye
481318|NCT00796861|B1|Baseline|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
481319|NCT00796861|P1|Participant Flow|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
481320|NCT00796861|O1|Outcome|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
481321|NCT00796861|E1|Reported Event|Single Arm|"Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx~Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total)."
481322|NCT00796822|B3|Baseline|Total|Total of all reporting groups
481323|NCT00796822|B2|Baseline|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
481324|NCT00796822|B1|Baseline|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
481325|NCT00796822|P2|Participant Flow|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
481326|NCT00796822|P1|Participant Flow|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
481327|NCT00796822|O2|Outcome|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
481328|NCT00796822|O1|Outcome|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
481329|NCT00796822|O2|Outcome|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
481330|NCT00796822|O1|Outcome|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
481331|NCT00796822|E2|Reported Event|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
481332|NCT00796822|E1|Reported Event|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
481421|NCT00796666|P1|Participant Flow|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481334|NCT00796757|P1|Participant Flow|Bevacizumab Plus (+) Interferon|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481335|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481336|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481337|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481338|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481339|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481340|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481341|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481342|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481343|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481344|NCT00796757|E1|Reported Event|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
481345|NCT00796744|B4|Baseline|Total|Total of all reporting groups
481346|NCT00796744|B3|Baseline|0.01% DSC127|0.01% DSC127 in Vehicle Control
481347|NCT00796744|B2|Baseline|0.03 % DSC127|0.03% DSC127 in Vehicle Control
481348|NCT00796744|B1|Baseline|Placebo Vehicle Control|control placebo vehicle
481349|NCT00796744|P3|Participant Flow|0.01% DSC127|0.01% DSC127 in Vehicle Control
481350|NCT00796744|P2|Participant Flow|0.03 % DSC127|0.03% DSC127 in Vehicle Control
481351|NCT00796744|P1|Participant Flow|Placebo Vehicle Control|control placebo vehicle
481352|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
481353|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
481354|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
481355|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
481356|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
481357|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
481358|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
481359|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
481360|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
481361|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
481362|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
481363|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
481364|NCT00796744|E3|Reported Event|0.01% DSC127|0.01% DSC127 in Vehicle Control
481365|NCT00796744|E2|Reported Event|0.03 % DSC127|0.03% DSC127 in Vehicle Control
481366|NCT00796744|E1|Reported Event|Placebo Vehicle Control|control placebo vehicle
481367|NCT00796718|B1|Baseline|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
481368|NCT00796718|P1|Participant Flow|Capecitabine|Capecitabine 825 milligrams per meter square (mg/m^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
481369|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
481370|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
481371|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
481372|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
481373|NCT00796718|E1|Reported Event|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
481375|NCT00796705|B4|Baseline|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481376|NCT00796705|B3|Baseline|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481377|NCT00796705|B2|Baseline|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481378|NCT00796705|B1|Baseline|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481379|NCT00796705|P4|Participant Flow|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481380|NCT00796705|P3|Participant Flow|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481381|NCT00796705|P2|Participant Flow|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481382|NCT00796705|P1|Participant Flow|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481383|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481384|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481385|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481386|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481387|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481388|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481389|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481390|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481391|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481392|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481393|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481394|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481395|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481396|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481397|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481398|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481399|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481400|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481401|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481402|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481722|NCT00796653|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481403|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481404|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481405|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481406|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481407|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481408|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481409|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481410|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
481411|NCT00796705|O2|Outcome|Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion and participants defined as etanercept failures [2] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg SQ injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481412|NCT00796705|O1|Outcome|Non-Switcher/ Adalimumab or Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion and participants defined as etanercept failures [2] at screening who were randomized to receive etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
481413|NCT00796705|E4|Reported Event|Switcher/Etanercept to Adalimumab|Subjects failing Etanercept at screening who were randomized to switch to Adalimumab
481414|NCT00796705|E3|Reported Event|Switcher/Adalimumab to Etanercept|Subjects failing Adalimumab at screening who were randomized to switch to Etanercept
481415|NCT00796705|E2|Reported Event|Non-Switcher/Etanercept|Subjects failing Etanercept at screening who were randomized to remain on Etanercept
481416|NCT00796705|E1|Reported Event|Non-Switcher/Adalimumab|Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab
481417|NCT00796666|B3|Baseline|Total|Total of all reporting groups
481418|NCT00796666|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481419|NCT00796666|B1|Baseline|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481420|NCT00796666|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481422|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481433|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481434|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481435|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481436|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481437|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481438|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481439|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481440|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481441|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481442|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481443|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481444|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481445|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481446|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481447|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481448|NCT00796666|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
481449|NCT00796666|E1|Reported Event|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
481450|NCT00796653|B5|Baseline|Total|Total of all reporting groups
481451|NCT00796653|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481452|NCT00796653|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481453|NCT00796653|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481454|NCT00796653|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481455|NCT00796653|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481456|NCT00796653|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481457|NCT00796653|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481458|NCT00796653|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481459|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481460|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481461|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481462|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481463|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481464|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481465|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481466|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481467|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481468|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481469|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481470|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481471|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481472|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481473|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481474|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481475|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481476|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481477|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481478|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481479|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481480|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481481|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481482|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481483|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
481484|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
481485|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
481723|NCT00796627|B3|Baseline|Total|Total of all reporting groups
481486|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
481487|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
481488|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
481489|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
481490|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
481491|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
481492|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
481493|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
481494|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
481495|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
481496|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
481497|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
481498|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
481499|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
481500|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
481501|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
481502|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
481503|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
481504|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
481505|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
481506|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
481507|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481508|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481509|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481510|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481511|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481512|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481513|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481514|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481515|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481516|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481517|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481518|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481519|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481520|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481521|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481522|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481523|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481524|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481525|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481526|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481527|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481528|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481529|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481530|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481531|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481532|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481533|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481534|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481535|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481536|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481537|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481538|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481539|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481543|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481544|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481545|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481546|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481547|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481548|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481549|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481550|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481551|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481552|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481553|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481554|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481555|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481556|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481557|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481558|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481559|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481560|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481561|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481562|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481563|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481564|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481565|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481566|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481567|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481568|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481569|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481570|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481571|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481572|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481573|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481574|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481575|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481576|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481577|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481578|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481579|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481580|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481581|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481582|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481583|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481584|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481585|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481586|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481587|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481588|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481589|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481590|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481591|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481592|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481593|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481594|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481595|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481596|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481597|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481598|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481599|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481600|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481601|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481602|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481603|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481604|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481605|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481606|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481607|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481608|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481609|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481610|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481611|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481612|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481613|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481614|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481615|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481616|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481617|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481618|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481619|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481620|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481621|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481622|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481623|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481624|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481625|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481626|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481627|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481628|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481629|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481630|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481631|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481632|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481633|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481634|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481635|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481636|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481637|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481638|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481639|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481640|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481641|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481642|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481643|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481644|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481645|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481646|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481647|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481648|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481649|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481650|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481651|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481652|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481653|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481654|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481655|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481656|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481657|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481658|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481659|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481660|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481661|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481662|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481663|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481664|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481665|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481666|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481667|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481668|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481669|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481670|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481671|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481672|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481673|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481674|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481675|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481676|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481677|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481678|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481679|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481680|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481681|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481682|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481683|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481684|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481685|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481686|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481687|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481688|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481689|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481690|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481691|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481692|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481693|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481694|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481695|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481696|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481697|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481698|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481699|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481700|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481701|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481702|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481703|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481704|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481705|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481706|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481707|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481708|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481709|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481710|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481711|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481712|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481713|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481714|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481715|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481716|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481717|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481718|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
481719|NCT00796653|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
481720|NCT00796653|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
481721|NCT00796653|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
481724|NCT00796627|B2|Baseline|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
481725|NCT00796627|B1|Baseline|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
481726|NCT00796627|P2|Participant Flow|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
481727|NCT00796627|P1|Participant Flow|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
481728|NCT00796627|O2|Outcome|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
481729|NCT00796627|O1|Outcome|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
481730|NCT00796627|O2|Outcome|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
481731|NCT00796627|O1|Outcome|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
481732|NCT00796627|O2|Outcome|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
481733|NCT00796627|O1|Outcome|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
481734|NCT00796627|O2|Outcome|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
481735|NCT00796627|O1|Outcome|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
481736|NCT00796627|E2|Reported Event|Burn Volunteer|"Burn wounded volunteers~Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers"
481737|NCT00796627|E1|Reported Event|Healthy Volunteers|"Healthy volunteers with no burn wounds~Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers"
481738|NCT00796614|B5|Baseline|Total|Total of all reporting groups
481739|NCT00796614|B4|Baseline|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481740|NCT00796614|B3|Baseline|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481741|NCT00796614|B2|Baseline|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481742|NCT00796614|B1|Baseline|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481743|NCT00796614|P4|Participant Flow|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481744|NCT00796614|P3|Participant Flow|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481745|NCT00796614|P2|Participant Flow|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481746|NCT00796614|P1|Participant Flow|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481747|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481748|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481749|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481819|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
494834|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
481750|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481751|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481752|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481753|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481754|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481755|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481756|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481757|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481758|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481759|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481760|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481761|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481762|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481763|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481764|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481765|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481766|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481820|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
481821|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
481767|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481768|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481769|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481770|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481771|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481772|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481773|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481774|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481775|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481776|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481777|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481778|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481779|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481780|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481781|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481782|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481783|NCT00796614|E4|Reported Event|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481822|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
481784|NCT00796614|E3|Reported Event|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481785|NCT00796614|E2|Reported Event|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481786|NCT00796614|E1|Reported Event|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
481787|NCT00796549|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481788|NCT00796549|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481789|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481790|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481791|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481792|NCT00796549|O2|Outcome|Afatinib 50mg 2nd Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
481793|NCT00796549|O1|Outcome|Afatinib 50mg 1st Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 1st line anti cancer treatment, indicating that they had not received prior treatment with chemotherapy.
481794|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481795|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481796|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481797|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481798|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481799|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481800|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
481801|NCT00796549|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)
481802|NCT00796523|B3|Baseline|Total|Total of all reporting groups
481803|NCT00796523|B2|Baseline|Control Videotape|videotape with normal newborn instruction
481804|NCT00796523|B1|Baseline|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
481805|NCT00796523|P2|Participant Flow|Control Videotape|videotape with normal newborn instruction
481806|NCT00796523|P1|Participant Flow|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
481807|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
481808|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
481809|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
481810|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
481811|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
481812|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
481813|NCT00796510|B3|Baseline|Total|Total of all reporting groups
481814|NCT00796510|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
481815|NCT00796510|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
481816|NCT00796510|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
481817|NCT00796510|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
481818|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
481824|NCT00796510|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
481825|NCT00796510|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
481826|NCT00796419|B3|Baseline|Total|Total of all reporting groups
481827|NCT00796419|B2|Baseline|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
481828|NCT00796419|B1|Baseline|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
481829|NCT00796419|P2|Participant Flow|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 6% hetastarch every 8 hours for 5 days
481830|NCT00796419|P1|Participant Flow|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 5% human albumin every 8 hours for 5 days
481831|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
481832|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
481833|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
481834|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
481835|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
481836|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
481837|NCT00796419|E2|Reported Event|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
481838|NCT00796419|E1|Reported Event|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
481839|NCT00796367|B4|Baseline|Total|Total of all reporting groups
481840|NCT00796367|B3|Baseline|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
481841|NCT00796367|B2|Baseline|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
481842|NCT00796367|B1|Baseline|Placebo|Placebo
481843|NCT00796367|P3|Participant Flow|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
481844|NCT00796367|P2|Participant Flow|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
481845|NCT00796367|P1|Participant Flow|Placebo|Placebo
481846|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
481847|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
481848|NCT00796367|O1|Outcome|Placebo|Placebo
481849|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
481850|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
481851|NCT00796367|O1|Outcome|Placebo|Placebo
481852|NCT00796367|E3|Reported Event|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
481853|NCT00796367|E2|Reported Event|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
481854|NCT00796367|E1|Reported Event|Placebo|Placebo
481855|NCT00796328|B1|Baseline|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
481856|NCT00796328|P1|Participant Flow|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
481857|NCT00796328|O1|Outcome|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
481858|NCT00796328|E1|Reported Event|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
481859|NCT00796315|B1|Baseline|Doxylamine Succinate USP|Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
481860|NCT00796315|P3|Participant Flow|Subjects Aged 12-17 Years (Doxylamine Suc|Ages 12-17 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
481861|NCT00796315|P2|Participant Flow|Aged 6-11 Years (Doxylamine Succinate|"Ages 6-11 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.~Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued."
481862|NCT00796315|P1|Participant Flow|Subjects Aged 2-5 Years (Doxylamine Succinate)|Ages 2-5 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
481863|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine Succinate USP
481864|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
481865|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
481866|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
481867|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Subjects received a dose of 4.17 or 6.25 or 8.33 or 10.42 mg Doxylamine Succinate USP (exact dose dependent upon body weight). Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued.
481868|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Subjects received a dose of either 3.125 or 4.17 mg Doxylamine Succinate USP (exact dose dependent upon body weight)
481869|NCT00796315|E3|Reported Event|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine succinate USP
481870|NCT00796315|E2|Reported Event|Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
481871|NCT00796315|E1|Reported Event|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
481872|NCT00796302|B3|Baseline|Total|Total of all reporting groups
481873|NCT00796302|B2|Baseline|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
481874|NCT00796302|B1|Baseline|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
481875|NCT00796302|P2|Participant Flow|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
481876|NCT00796302|P1|Participant Flow|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
481877|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
481878|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
481879|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
481880|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
481881|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
481882|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
481883|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and risperidone. Parents will receive parent management training
481884|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
481885|NCT00796302|E2|Reported Event|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
481886|NCT00796302|E1|Reported Event|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
481887|NCT00796224|B3|Baseline|Total|Total of all reporting groups
481888|NCT00796224|B2|Baseline|30 mg/kg Azithromycin IR|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
481889|NCT00796224|B1|Baseline|60 mg/kg Azithromycin ER|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
481890|NCT00796224|P2|Participant Flow|30 mg/kg Azithromycin Immediate-release (IR)|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
481891|NCT00796224|P1|Participant Flow|60 mg/kg Azithromycin Extended-release (ER)|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
481892|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
481893|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
481894|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
481895|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
481896|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR (Reference)|
481897|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER (Test)|
481898|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
481899|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
481900|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
481901|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
481902|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
481903|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
481904|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
481905|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
481906|NCT00796224|E2|Reported Event|30 mg/kg Azithromycin IR|
481907|NCT00796224|E1|Reported Event|60 mg/kg Azithromycin ER|
481908|NCT00796120|B3|Baseline|Total|Total of all reporting groups
481909|NCT00796120|B2|Baseline|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481910|NCT00796120|B1|Baseline|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481911|NCT00796120|P2|Participant Flow|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481912|NCT00796120|P1|Participant Flow|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481913|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481914|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481915|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481916|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481917|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481918|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481919|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481920|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481921|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481922|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481923|NCT00796120|E2|Reported Event|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
481924|NCT00796120|E1|Reported Event|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
481925|NCT00796003|B3|Baseline|Total|Total of all reporting groups
481926|NCT00796003|B2|Baseline|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
481927|NCT00796003|B1|Baseline|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481928|NCT00796003|P2|Participant Flow|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
481929|NCT00796003|P1|Participant Flow|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481930|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481931|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481932|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481933|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481934|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481935|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481936|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481937|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481938|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481939|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481940|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481941|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481942|NCT00796003|O3|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481943|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481944|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
481945|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481946|NCT00796003|E3|Reported Event|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
481947|NCT00796003|E2|Reported Event|Phase I - 20 mg/m2 Group|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
481948|NCT00796003|E1|Reported Event|Phase I - 15 mg/m2 Group|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
481949|NCT00795951|B1|Baseline|Single Arm Study|All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1
481950|NCT00795951|P1|Participant Flow|Diagnostic Performance: Nickel Sulfate|Number of subjects with reactions recorded at visit 3 or 4
481951|NCT00795951|O1|Outcome|Itching|Number of subjects who presented with itching at patch removal
481952|NCT00795951|O1|Outcome|Adhesion|Number of subjects who presented with poor adhesion at patch removal
481953|NCT00795951|O1|Outcome|Irritation|Number of subjects who presented with irritation at patch removal
481954|NCT00795951|O1|Outcome|Persistent Reactions|Number of subjects who presented with persistent reactions
481955|NCT00795951|O1|Outcome|Late Reactions|Number of subjects who presented with late reactions
481956|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
482334|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|Zyvox IV Injection
481957|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481958|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481959|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481960|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481961|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481962|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481963|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481964|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481965|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481966|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481967|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481968|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481969|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481970|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481971|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481972|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481973|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481974|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481975|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481976|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481977|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481978|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481979|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481980|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481981|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481982|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481983|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
481984|NCT00795951|O1|Outcome|Diagnostic Performance: Nickel Sulfate|Number of subjects with a positive reaction to nickel sulfate at visit 3 or visit 4
481985|NCT00795951|E1|Reported Event|Safety|Adverse Events
481986|NCT00795886|B1|Baseline|Rapamycin|This includes all study participants.
481987|NCT00795886|P1|Participant Flow|Rapamycin|This includes all study participants.
481988|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
481989|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
481990|NCT00795886|O1|Outcome|Rate of Transplant Related Mortality|All participants enrolled in the trial
481991|NCT00795886|E1|Reported Event|Rapamycin|This includes all study participants.
481992|NCT00795821|B3|Baseline|Total|Total of all reporting groups
481993|NCT00795821|B2|Baseline|Placebo|"10-week Acute Treatment Phase: 3 tablets QD for 10 weeks~1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
481994|NCT00795821|B1|Baseline|LY2216684|"10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.~1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
481995|NCT00795821|P2|Participant Flow|Placebo|"10-week Acute Treatment Phase: 3 tablets QD for 10 weeks~1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
481996|NCT00795821|P1|Participant Flow|LY2216684|"10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.~1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
482021|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482076|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
481997|NCT00795821|O1|Outcome|LY2216684|"10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.~1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of acute treatment phase, or 6 mg LY2216684 dose if participants were taking placebo; After Week 1=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62)."
481998|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
481999|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482000|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482001|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482002|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482003|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482004|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482005|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482006|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482007|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482008|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482009|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482010|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482011|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482012|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482013|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482014|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482015|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482016|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482017|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482018|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482019|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482020|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482075|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily"
482022|NCT00795821|O2|Outcome|Placebo|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482023|NCT00795821|O1|Outcome|LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482024|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482025|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482026|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482027|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482028|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482029|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482030|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482031|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482032|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482033|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482034|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482035|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482036|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482037|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482038|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482039|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482040|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482041|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482042|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684 dose; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482043|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482044|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482045|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482046|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482077|NCT00795717|O2|Outcome|Placebo|"Corn oil, dietary counseling~Corn oil : 2 capsules given twice daily"
482335|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
482047|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482048|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482049|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482050|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482051|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482052|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482053|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482054|NCT00795821|O2|Outcome|Placebo/LY2216684|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482055|NCT00795821|O1|Outcome|LY2216684/LY2216684|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482056|NCT00795821|O2|Outcome|Placebo|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482057|NCT00795821|O1|Outcome|LY2216684|10-week Acute Treatment Phase: Day after Week 0=start of 6 mg QD dosing; Week 1=all participants were titrated to 9 mg QD; After Week 1=dose was increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482058|NCT00795821|E6|Reported Event|Placebo - Taper|Participants who took placebo remained on placebo for 2 weeks.
482059|NCT00795821|E5|Reported Event|LY2216684 - Taper|Participants who took 18 mg LY2216684 received 12 mg QD for 1 week followed by 6 mg QD for 1 week. Participants who took 12 mg, 9 mg, or 6 mg LY2216684 received 6 mg QD for 2 weeks.
482060|NCT00795821|E4|Reported Event|Placebo/LY2216684 - Extension|1-year Long-term Extension Phase: Day after Week 10=6 mg LY2216684; After 1 week=dose escalated to 9 mg QD; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482061|NCT00795821|E3|Reported Event|LY2216684/LY2216684 - Extension|1-year Long-term Extension Phase: Day after Week 10=start of same LY2216684 dose participant was taking at the end of Acute Treatment Phase; After Week 11=dose increased, maintained, or decreased to minimum of 6 mg QD and maximum of 18 mg QD based on investigator's judgment of safety and tolerability (up to Week 62).
482062|NCT00795821|E2|Reported Event|Placebo - Acute|10-week Acute Treatment Phase: 3 tablets QD for 10 weeks
482063|NCT00795821|E1|Reported Event|LY2216684 - Acute|10-week Acute Treatment Phase: Day after Week 0=start of 6 milligram (mg) once daily (QD) dosing; Week 1=all participants titrated to 9 mg QD; After Week 1=dose increased, maintained, or decreased to a minimum of 6 mg QD and maximum of 18 mg QD, depending on participant's tolerance of study drug.
482064|NCT00795769|B1|Baseline|Ondansteron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
482065|NCT00795769|P1|Participant Flow|Ondansetron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
482066|NCT00795769|O1|Outcome|Ondansetron Therapy|"Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
482067|NCT00795769|E1|Reported Event|Ondansteron Therapy|"Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
482068|NCT00795717|B3|Baseline|Total|Total of all reporting groups
482069|NCT00795717|B2|Baseline|Placebo Then Lovaza|"Placebo or Corn oil pill, dietary counseling~Corn oil pill : 2 capsules given twice daily for 12 weeks"
482070|NCT00795717|B1|Baseline|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
482071|NCT00795717|P2|Participant Flow|Placebo Then Lovaza|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks"
482072|NCT00795717|P1|Participant Flow|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily."
482073|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily"
482074|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
482078|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
482079|NCT00795717|E2|Reported Event|Placebo|Placebo, dietary counseling
482080|NCT00795717|E1|Reported Event|Lovaza-Active|Lovaza, dietary counseling
482081|NCT00795704|B3|Baseline|Total|Total of all reporting groups
482082|NCT00795704|B2|Baseline|Mulberry Leaf Extract|500 mg #2 capsules three times daily
482083|NCT00795704|B1|Baseline|Placebo|Control Group
482084|NCT00795704|P2|Participant Flow|Mulberry Leaf Extract|500 mg #2 capsules three times daily
482085|NCT00795704|P1|Participant Flow|Placebo|Control Group
482086|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
482087|NCT00795704|O1|Outcome|Placebo|Control Group
482088|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
482089|NCT00795704|O1|Outcome|Placebo|Control Group
482090|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
482091|NCT00795704|O1|Outcome|Placebo|Control Group
482092|NCT00795704|E2|Reported Event|Mulberry Leaf Extract|500 mg #2 capsules three times daily
482093|NCT00795704|E1|Reported Event|Placebo|Control Group
482094|NCT00795639|B3|Baseline|Total|Total of all reporting groups
482095|NCT00795639|B2|Baseline|Placebo|Matching placebo tablet once a day
482096|NCT00795639|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
482097|NCT00795639|P2|Participant Flow|Placebo|Matching placebo tablet once a day
482098|NCT00795639|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
482099|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
482100|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
482101|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
482102|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
482103|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
482104|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
482105|NCT00795639|E2|Reported Event|Placebo|Matching placebo tablet once a day
482106|NCT00795639|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
482107|NCT00795600|B3|Baseline|Total|Total of all reporting groups
482108|NCT00795600|B2|Baseline|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482109|NCT00795600|B1|Baseline|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482110|NCT00795600|P2|Participant Flow|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482111|NCT00795600|P1|Participant Flow|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482112|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482113|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482114|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482115|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482116|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482117|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482118|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482119|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482120|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482121|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482122|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482123|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482124|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482125|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482126|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482127|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482128|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482129|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482130|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482131|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482132|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482133|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482134|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482135|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482136|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482137|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482138|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482139|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482140|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482141|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482142|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482143|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482144|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482145|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482146|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482147|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482148|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482149|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482150|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482151|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482152|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482153|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482154|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482155|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482156|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482157|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482158|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482159|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482160|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482161|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482230|NCT00795535|B1|Baseline|Trauma Patients|Patients transported to the trauma center by helicopter
482162|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482163|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482164|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482165|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482166|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482167|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482168|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482169|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482170|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482171|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482172|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482173|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482174|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482175|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482176|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482177|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482178|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482179|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482180|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482181|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482182|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482183|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482184|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482185|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482186|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482187|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482188|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482189|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482190|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482191|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482192|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482193|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482194|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482195|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482323|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
482196|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482197|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482198|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482199|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482200|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482201|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482202|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482203|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482204|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482205|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482206|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482207|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482208|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482209|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482210|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482211|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482212|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482213|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482214|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482215|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482216|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482217|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482218|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482219|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482220|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482221|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482222|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482223|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482224|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482225|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482226|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482227|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482228|NCT00795600|E2|Reported Event|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482229|NCT00795600|E1|Reported Event|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
482324|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
482231|NCT00795535|P1|Participant Flow|Trauma Patients|Patients transported to the trauma center by helicopter
482232|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
482233|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
482234|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
482235|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
482236|NCT00795535|E1|Reported Event|Trauma Patients|Patients transported to the trauma center by helicopter
482237|NCT00795509|B1|Baseline|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
482238|NCT00795509|P1|Participant Flow|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
482239|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
482240|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
482241|NCT00795509|E1|Reported Event|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
482242|NCT00795366|B3|Baseline|Total|Total of all reporting groups
482243|NCT00795366|B2|Baseline|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
482244|NCT00795366|B1|Baseline|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
482245|NCT00795366|P2|Participant Flow|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
482246|NCT00795366|P1|Participant Flow|AVP, Arginine Vasopressin|Vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
482247|NCT00795366|O2|Outcome|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
482248|NCT00795366|O1|Outcome|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
482249|NCT00795366|E2|Reported Event|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
482250|NCT00795366|E1|Reported Event|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
482251|NCT00795340|B3|Baseline|Total|Total of all reporting groups
482252|NCT00795340|B2|Baseline|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
482253|NCT00795340|B1|Baseline|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
482254|NCT00795340|P2|Participant Flow|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
482255|NCT00795340|P1|Participant Flow|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
482256|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
482257|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
482258|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
482259|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
482260|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
482261|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
482262|NCT00795340|E2|Reported Event|Placebo|Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
482263|NCT00795340|E1|Reported Event|Cediranib|Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
482264|NCT00795288|B3|Baseline|Total|Total of all reporting groups
482265|NCT00795288|B2|Baseline|Control|placebo: Control group
482266|NCT00795288|B1|Baseline|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
482267|NCT00795288|P2|Participant Flow|Simvastatin|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
482268|NCT00795288|P1|Participant Flow|Placebo|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
482269|NCT00795288|O2|Outcome|Placebo|"Placebo~placebo: Control group"
482270|NCT00795288|O1|Outcome|Simvastatin, 80 mg/Day|"Simvastatin, 80 mg/day for 21 days~Simvastatin, 80 mg/day for 21 days: Active treatment group"
482271|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
482272|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
482273|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
482274|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
482275|NCT00795288|E2|Reported Event|Control|placebo: Control group
482276|NCT00795288|E1|Reported Event|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
482277|NCT00795210|B4|Baseline|Total|Total of all reporting groups
482278|NCT00795210|B3|Baseline|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
482279|NCT00795210|B2|Baseline|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
482280|NCT00795210|B1|Baseline|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
482281|NCT00795210|P3|Participant Flow|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
482282|NCT00795210|P2|Participant Flow|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
482283|NCT00795210|P1|Participant Flow|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
482284|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
482285|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
482286|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
482287|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
482288|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
482289|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
482290|NCT00795210|E3|Reported Event|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
482291|NCT00795210|E2|Reported Event|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
482292|NCT00795210|E1|Reported Event|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
482293|NCT00795184|B1|Baseline|Group 1|NBI-pCLE
482294|NCT00795184|P2|Participant Flow|NBI First HDWLE Second and pCLE|
482295|NCT00795184|P1|Participant Flow|HDWLE First NBI Second and pCLE|
482296|NCT00795184|O6|Outcome|HDWLE+NBI|
482297|NCT00795184|O5|Outcome|HDWLE+pCLE|
482298|NCT00795184|O4|Outcome|HDWLE+NBI+pCLE|
482299|NCT00795184|O3|Outcome|pCLE|
482300|NCT00795184|O2|Outcome|NBI (Narrow Band Imaging)|
482301|NCT00795184|O1|Outcome|HDWLE|
482302|NCT00795184|E1|Reported Event|Group 1|NBI-pCLE or pCLE-NBI
482303|NCT00795145|B3|Baseline|Total|Total of all reporting groups
482304|NCT00795145|B2|Baseline|Cohort 2: Placebo, Linezolid 600 mg and 1200 mg, Moxifloxacin|Subjects were randomly assigned to placebo first then moxifloxacin followed by linezolid 600 mg and 1200 mg linezolid last in Sequence 1; or linezolid 600 mg first then linezolid 1200 mg followed by placebo and moxifloxacin last in Sequence 2; or, linezolid 1200 mg first then moxifloxacin 400 mg followed by linezolid 600 mg and placebo last in Sequence 3; or, moxifloxacin 400 mg first then placebo followed by linezolid 1200 mg and 600 mg linezolid last in Sequence 4. There was a washout period of 48 hours between each dose.
482305|NCT00795145|B1|Baseline|Cohort 1: Placebo, Linezolid 900 mg and 1200 mg|Subjects were randomly assigned to placebo followed by linezolid 900 mg then 1200 mg linezolid in Sequence 1; or, linezolid 900 mg then linezolid 1200 mg followed by placebo in Sequence 2; or, linezolid 900 mg then placebo followed by linezolid 1200 mg in Sequence 3. There was a washout period of 48 hours between doses.
482306|NCT00795145|P7|Participant Flow|Cohort 2: Sequence 4|Subjects were randomly assigned to moxifloxacin 400 mg first, then placebo followed by linezolid 1200 mg and 600 mg linezolid after a washout period of 48 hours between doses in Sequence 4.
482307|NCT00795145|P6|Participant Flow|Cohort 2: Sequence 3|Subjects were randomly assigned to linezolid 1200 mg first, then moxifloxacin 400 mg followed by linezolid 600 mg and placebo after a washout period of 48 hours between doses in Sequence 3.
482308|NCT00795145|P5|Participant Flow|Cohort 2: Sequence 2|Subjects were randomly assigned to linezolid 600 mg first, then linezolid 1200 mg followed by placebo and moxifloxacin, after a washout period of 48 hours between doses in Sequence 2.
482309|NCT00795145|P4|Participant Flow|Cohort 2: Sequence 1|Subjects were randomly assigned to placebo, then moxifloxacin, followed by linezolid 600 mg and 1200 mg, after a washout period of 48 hours between doses in Sequence 1.
482310|NCT00795145|P3|Participant Flow|Cohort 1: Sequence 3|Subjects were randomly assigned to linezolid 900 mg first, then 1200 mg linezolid, followed by placebo after a washout period of 48 hours between doses in Sequence 3.
482311|NCT00795145|P2|Participant Flow|Cohort 1: Sequence 2|Subjects were randomly assigned to linezolid 900 mg first, then placebo, followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 2.
482312|NCT00795145|P1|Participant Flow|Cohort 1: Sequence 1|Subjects were randomly assigned to placebo first, then linezolid 900 milligrams (mg) followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 1.
482313|NCT00795145|O4|Outcome|Moxifloxacin 400 mg|
482314|NCT00795145|O3|Outcome|Cohort 2: Placebo|
482315|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
482316|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
482317|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
482318|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
482319|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
482320|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
482321|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
482322|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
482345|NCT00795145|O3|Outcome|Cohort 1: 1200 mg Linezolid|600 mL Zyvox as a constant rate IV infusion of 60 minutes.
482346|NCT00795145|O2|Outcome|Cohort 1: 900 mg Linezolid|450 mL Zyvox plus 150 mL saline as a constant rate IV infusion of 60 minutes.
482347|NCT00795145|O1|Outcome|Cohort 1: Placebo|600 milliliters (mL) saline as a constant rate intravenous (IV) infusion of 60 minutes.
482348|NCT00795145|E7|Reported Event|Cohort 2: 400 mg Moxifloxacin|
482349|NCT00795145|E6|Reported Event|Cohort 2: 1200 mg Linezolid|
482350|NCT00795145|E5|Reported Event|Cohort 2: 600 mg Linezolid|
482351|NCT00795145|E4|Reported Event|Cohort 2: Placebo|
482352|NCT00795145|E3|Reported Event|Cohort 1: 1200 mg Linezolid|
482353|NCT00795145|E2|Reported Event|Cohort 1: 900 mg Linezolid|
482354|NCT00795145|E1|Reported Event|Cohort 1: Placebo|
482355|NCT00795132|B1|Baseline|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
482356|NCT00795132|P1|Participant Flow|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
482357|NCT00795132|O3|Outcome|Unrelated Cord Blood|All incidences of enrolled patients were analyzed.
482358|NCT00795132|O2|Outcome|Unrelated BM PBSC|All incidences of enrolled patients were analyzed.
482359|NCT00795132|O1|Outcome|Related BM PBSC|All incidences of enrolled patients were analyzed.
482360|NCT00795132|O3|Outcome|Unrelated Cord Blood|All participants were analyzed.
482361|NCT00795132|O2|Outcome|Unrelated BM PBSC|All participants were analyzed.
482362|NCT00795132|O1|Outcome|Related BM PBSC|All participants were analyzed.
482363|NCT00795132|O3|Outcome|Unrelated Cord Blood|Unrelated donor: Cord Blood
482364|NCT00795132|O2|Outcome|Unrelated BM PBSC|Unrelated donor: bone marrow or peripheral blood stem cell (PBSC)
482365|NCT00795132|O1|Outcome|Related BM PBSC|Related donor: bone marrow or peripheral blood stem cell (PBSC)
482366|NCT00795132|E1|Reported Event|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
482367|NCT00795002|B3|Baseline|Total|Total of all reporting groups
482368|NCT00795002|B2|Baseline|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
482369|NCT00795002|B1|Baseline|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
482370|NCT00795002|P2|Participant Flow|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
482371|NCT00795002|P1|Participant Flow|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
482372|NCT00795002|O2|Outcome|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
482373|NCT00795002|O1|Outcome|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
482374|NCT00795002|E2|Reported Event|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
482375|NCT00795002|E1|Reported Event|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
482376|NCT00794963|B3|Baseline|Total|Total of all reporting groups
482377|NCT00794963|B2|Baseline|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
482378|NCT00794963|B1|Baseline|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
482379|NCT00794963|P2|Participant Flow|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
482380|NCT00794963|P1|Participant Flow|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
482381|NCT00794963|O2|Outcome|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
482382|NCT00794963|O1|Outcome|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
482383|NCT00794963|E2|Reported Event|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
482384|NCT00794963|E1|Reported Event|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
482385|NCT00794924|B3|Baseline|Total|Total of all reporting groups
482386|NCT00794924|B2|Baseline|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
482387|NCT00794924|B1|Baseline|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
482388|NCT00794924|P2|Participant Flow|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
482389|NCT00794924|P1|Participant Flow|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
482390|NCT00794924|O2|Outcome|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
482391|NCT00794924|O1|Outcome|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
494835|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
482392|NCT00794820|B1|Baseline|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
482393|NCT00794820|P1|Participant Flow|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
482394|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
482395|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
482396|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
482397|NCT00794820|E1|Reported Event|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
482398|NCT00794677|B3|Baseline|Total|Total of all reporting groups
482399|NCT00794677|B2|Baseline|Placebo|Placebo once daily received as the first or second intervention
482400|NCT00794677|B1|Baseline|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482401|NCT00794677|P2|Participant Flow|Placebo|Placebo once daily received as the first or second intervention
482402|NCT00794677|P1|Participant Flow|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482403|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482404|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482405|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482406|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482407|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482408|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482409|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482410|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482411|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482412|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482413|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482414|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482415|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482416|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482417|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482418|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482419|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
482420|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
482421|NCT00794664|B3|Baseline|Total|Total of all reporting groups
482422|NCT00794664|B2|Baseline|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482423|NCT00794664|B1|Baseline|Placebo|Weekly subcutaneous injections for 26 weeks
482424|NCT00794664|P2|Participant Flow|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482425|NCT00794664|P1|Participant Flow|Placebo|Weekly subcutaneous injections for 26 weeks
482426|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482427|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482428|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482429|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482430|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482431|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482432|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482433|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482434|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482435|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482436|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482437|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482438|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482439|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482440|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482441|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482442|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482443|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482444|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482445|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482446|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482447|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482448|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482449|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482450|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482451|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482452|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482453|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482454|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482455|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482456|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482457|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482458|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482459|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482460|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482461|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482462|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482463|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482464|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482465|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
482466|NCT00794664|E2|Reported Event|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
482467|NCT00794664|E1|Reported Event|Placebo|Weekly subcutaneous injections for 26 weeks
482468|NCT00794560|B5|Baseline|Total|Total of all reporting groups
482469|NCT00794560|B4|Baseline|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
482470|NCT00794560|B3|Baseline|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482471|NCT00794560|B2|Baseline|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
482472|NCT00794560|B1|Baseline|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482473|NCT00794560|P4|Participant Flow|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
482474|NCT00794560|P3|Participant Flow|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482475|NCT00794560|P2|Participant Flow|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
482476|NCT00794560|P1|Participant Flow|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482477|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
482478|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482479|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
482498|NCT00794508|B1|Baseline|Experimental Retroviral-mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
482480|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482481|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
482482|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482483|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
482484|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482485|NCT00794560|E4|Reported Event|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
482486|NCT00794560|E3|Reported Event|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482487|NCT00794560|E2|Reported Event|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
482488|NCT00794560|E1|Reported Event|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
482489|NCT00794547|B1|Baseline|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
482490|NCT00794547|P2|Participant Flow|Phase 2|"In the Phase II part of the study, we will find out the response of subjects' cancer has to the combination of a fixed dose of calcitriol (determined in the phase I study) with standard chemotherapy.~Calcitriol: In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy"
482491|NCT00794547|P1|Participant Flow|Phase 1|"In the Phase I part of the study, we will test the safety of calcitriol along with standard chemotherapy. In addition, the goal is to see what effects (good and bad) it has on you and your type of Non-Small Cell Lung Cancer. This study is ongoing. In this portion of the study, we are testing increasing doses of calcitriol in combination with standard chemotherapy. If 2/3 patients at any dose level experience side effects that are limiting, we will call the dose level below that dose the maximum tolerated dose.~Calcitriol: Escalating dose of Calcitriol will be infused IV over 1 hour every 21 days."
482492|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
482493|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
482494|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
482495|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
482496|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
482497|NCT00794547|E1|Reported Event|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
482727|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482499|NCT00794508|P1|Participant Flow|Gamma-retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the gamma-retroviral vector, MND-ADA, carrying the human ADA gene."
482500|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
482501|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
482502|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
482503|NCT00794508|E1|Reported Event|Retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the retroviral vector MND-ADA, carrying the human ADA gene."
482504|NCT00794469|B1|Baseline|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
482505|NCT00794469|P1|Participant Flow|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
482506|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
482507|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
482508|NCT00794469|E1|Reported Event|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
482509|NCT00794365|B1|Baseline|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
482510|NCT00794365|P1|Participant Flow|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
482511|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
482512|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
482513|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
482514|NCT00794365|E1|Reported Event|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
482515|NCT00794313|B1|Baseline|All Study Participants|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks or Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week or Sugar Pill : sugar pill, capsule, three times a day, 2 weeks"
482516|NCT00794313|P3|Participant Flow|Placebo, Then Amantadine, Then Amantadine + Topiramate|Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2)
482517|NCT00794313|P2|Participant Flow|Amantadine + Topiramate, Then Placebo, Then Amantadine|Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2)
482518|NCT00794313|P1|Participant Flow|Amantadine, Then Amantadine + Topiramate, Then Placebo|Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks
482519|NCT00794313|O3|Outcome|Sugar Pill|Sugar Pill: sugar pill, capsule, three times a day, 2 weeks
482520|NCT00794313|O2|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate: Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
482521|NCT00794313|O1|Outcome|Amantadine|Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks
482522|NCT00794313|O3|Outcome|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
482523|NCT00794313|O2|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
482524|NCT00794313|O1|Outcome|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
482525|NCT00794313|E3|Reported Event|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
482526|NCT00794313|E2|Reported Event|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
482527|NCT00794313|E1|Reported Event|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
482528|NCT00794196|B3|Baseline|Total|Total of all reporting groups
482602|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482529|NCT00794196|B2|Baseline|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
482530|NCT00794196|B1|Baseline|Usual Care|The control group will be receiving usual medical and pharmaceutical care.
482531|NCT00794196|P2|Participant Flow|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
482532|NCT00794196|P1|Participant Flow|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
482533|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
482534|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
482535|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
482536|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
482537|NCT00794196|E2|Reported Event|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
482538|NCT00794196|E1|Reported Event|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
482539|NCT00794170|B3|Baseline|Total|Total of all reporting groups
482540|NCT00794170|B2|Baseline|Usual Care|control
482541|NCT00794170|B1|Baseline|Telephone and Print Based Intervention|This was a tailored phone call followed up by print materials.
482542|NCT00794170|P2|Participant Flow|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection.
482543|NCT00794170|P1|Participant Flow|Telephone and Print Based Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
482544|NCT00794170|O2|Outcome|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection. Both groups receive birthday cards from the study team.
482545|NCT00794170|O1|Outcome|Telephone and Print Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
482546|NCT00794170|E2|Reported Event|Usual Care|
482547|NCT00794170|E1|Reported Event|Telephone and Print Based Intervention|
482548|NCT00794157|B4|Baseline|Total|Total of all reporting groups
482549|NCT00794157|B3|Baseline|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482550|NCT00794157|B2|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482551|NCT00794157|B1|Baseline|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482552|NCT00794157|P3|Participant Flow|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483377|NCT00793611|B1|Baseline|Behavioral Therapy Standard Care|received 3 behavioral therapy session
482553|NCT00794157|P2|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482554|NCT00794157|P1|Participant Flow|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482555|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482556|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482557|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482558|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482559|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482560|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482561|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482562|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482563|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482564|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482565|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482566|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482567|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482568|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482569|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482570|NCT00794157|E3|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482603|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
483695|NCT00792636|P2|Participant Flow|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
482571|NCT00794157|E2|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482572|NCT00794157|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
482573|NCT00794144|B3|Baseline|Total|Total of all reporting groups
482574|NCT00794144|B2|Baseline|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
482575|NCT00794144|B1|Baseline|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
482576|NCT00794144|P2|Participant Flow|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
482577|NCT00794144|P1|Participant Flow|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
482578|NCT00794144|O2|Outcome|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
482579|NCT00794144|O1|Outcome|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
482580|NCT00794144|E2|Reported Event|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
482581|NCT00794144|E1|Reported Event|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
482582|NCT00794118|B1|Baseline|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482583|NCT00794118|P1|Participant Flow|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482584|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482585|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482586|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482587|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482588|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482589|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482590|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482591|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482592|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482593|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482594|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482595|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482596|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482597|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482598|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482599|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482600|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482601|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
483813|NCT00792116|O1|Outcome|Gum Chewing|
482604|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482605|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482606|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482607|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482608|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482609|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482610|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482611|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482612|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482613|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482614|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482615|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482616|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482617|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482618|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482619|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482620|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482621|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482622|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482623|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482624|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482625|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482626|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482627|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482628|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482629|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482630|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482678|NCT00793793|B11|Baseline|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482631|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482632|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482633|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482634|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482635|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482636|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482637|NCT00794118|E1|Reported Event|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
482638|NCT00793910|B3|Baseline|Total|Total of all reporting groups
482639|NCT00793910|B2|Baseline|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482640|NCT00793910|B1|Baseline|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482641|NCT00793910|P2|Participant Flow|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482642|NCT00793910|P1|Participant Flow|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482643|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482644|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482645|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482646|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482647|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482648|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482649|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482650|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482651|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482652|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482653|NCT00793910|E2|Reported Event|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
482654|NCT00793910|E1|Reported Event|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
482655|NCT00793871|B1|Baseline|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482656|NCT00793871|P1|Participant Flow|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482657|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482658|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482679|NCT00793793|B10|Baseline|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482680|NCT00793793|B9|Baseline|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483814|NCT00792116|O2|Outcome|Non-Gum Chewing|
482659|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482660|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482661|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482662|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482663|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482664|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482665|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482666|NCT00793871|E1|Reported Event|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
482667|NCT00793819|B3|Baseline|Total|Total of all reporting groups
482668|NCT00793819|B2|Baseline|Placebo|1 placebo capsule daily
482669|NCT00793819|B1|Baseline|Silodosin 8mg|Silodosin 8mg daily
482670|NCT00793819|P2|Participant Flow|Placebo|1 placebo capsule daily
482671|NCT00793819|P1|Participant Flow|Silodosin 8mg|Silodosin 8mg daily
482672|NCT00793819|O2|Outcome|Placebo|1 placebo capsule daily
482673|NCT00793819|O1|Outcome|Silodosin 8mg|Silodosin 8mg daily
482674|NCT00793819|E2|Reported Event|Placebo|1 placebo capsule daily
482675|NCT00793819|E1|Reported Event|Silodosin 8mg|Silodosin 8mg daily
482676|NCT00793793|B13|Baseline|Total|Total of all reporting groups
482677|NCT00793793|B12|Baseline|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483815|NCT00792116|O1|Outcome|Gum Chewing|
482681|NCT00793793|B8|Baseline|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482682|NCT00793793|B7|Baseline|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482683|NCT00793793|B6|Baseline|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482684|NCT00793793|B5|Baseline|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482685|NCT00793793|B4|Baseline|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482686|NCT00793793|B3|Baseline|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482687|NCT00793793|B2|Baseline|TN: 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482688|NCT00793793|B1|Baseline|Treatment Naive (TN): Placebo|TN patient to receive Placebo + PegIFN/RBV for 28 days
482689|NCT00793793|P12|Participant Flow|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482690|NCT00793793|P11|Participant Flow|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482691|NCT00793793|P10|Participant Flow|TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482692|NCT00793793|P9|Participant Flow|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482693|NCT00793793|P8|Participant Flow|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482694|NCT00793793|P7|Participant Flow|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482695|NCT00793793|P6|Participant Flow|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482696|NCT00793793|P5|Participant Flow|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482697|NCT00793793|P4|Participant Flow|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482698|NCT00793793|P3|Participant Flow|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482699|NCT00793793|P2|Participant Flow|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482700|NCT00793793|P1|Participant Flow|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
482701|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482702|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482703|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482704|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482705|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482706|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482707|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482708|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482709|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482710|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482711|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482712|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482713|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482714|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482715|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482716|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482717|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482718|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482719|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482720|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482721|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482722|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482723|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482724|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482725|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482726|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482728|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482729|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482730|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482731|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482732|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482733|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482734|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482735|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482736|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482737|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482738|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482739|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482740|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482741|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482742|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482743|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482744|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482745|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482746|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482747|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482748|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482749|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482750|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482751|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482752|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482753|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482754|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482755|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482756|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482757|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482758|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482759|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482760|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482761|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482762|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482763|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482764|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482765|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482766|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482767|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482768|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482769|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482770|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482771|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482772|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482773|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483816|NCT00792116|O2|Outcome|Non-Gum Chewing|
482774|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482775|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482776|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482777|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482778|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482779|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482780|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482781|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482782|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482783|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482784|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482785|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482786|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482787|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482788|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482789|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482790|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482791|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482792|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482793|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482794|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482795|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482796|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482797|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482798|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482799|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482800|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482801|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482802|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482803|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482804|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482805|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482806|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482807|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482808|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482809|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482810|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482811|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482812|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482813|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482814|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482815|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482816|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482817|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482818|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482819|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482820|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482821|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482822|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482823|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482824|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482825|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482826|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482827|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482828|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482829|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482830|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482831|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482832|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482833|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482834|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482835|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482836|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482837|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482838|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482839|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482840|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482841|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482842|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482843|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482844|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482845|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482846|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482847|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482848|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482849|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482850|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482851|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482852|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482853|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482854|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482855|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482856|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482857|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482858|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482859|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482860|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482861|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482862|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482863|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482864|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482865|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483817|NCT00792116|O1|Outcome|Gum Chewing|
482866|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482867|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
482868|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482869|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482870|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482871|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482872|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482873|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482874|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE patient non-cirrhotic to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482875|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482876|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482877|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482878|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482879|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
482880|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482881|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482882|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482883|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482884|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482885|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482886|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482887|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482888|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482889|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482890|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482891|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
482892|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482893|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482894|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482895|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482896|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482897|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482898|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482899|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482900|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482901|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482902|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482903|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
482904|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482905|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482906|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482907|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482908|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482909|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482910|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483818|NCT00792116|O2|Outcome|Non-Gum Chewing|
482911|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482912|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482913|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482914|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482915|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
482916|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482917|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482918|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482919|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482920|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482921|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482922|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482923|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482924|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482925|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482926|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482927|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
482928|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482929|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482930|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482931|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482932|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482933|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482934|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482935|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482936|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482937|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482938|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482939|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
482940|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482941|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482942|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482943|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482944|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482945|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482946|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482947|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482948|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482949|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482950|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482951|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
482952|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482953|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482954|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482955|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482956|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482957|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482958|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482959|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482960|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482961|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482962|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482963|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
482964|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482965|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482966|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482967|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482968|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482969|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482970|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482971|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482972|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482973|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482974|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482975|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
482976|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482977|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482978|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482979|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482980|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482981|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482982|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482983|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482984|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482985|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482986|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482987|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
482988|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482989|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482990|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482991|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
482992|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482993|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482994|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
482995|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482996|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482997|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
482998|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
482999|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
483000|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483001|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483002|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483003|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483004|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483005|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483006|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483007|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483008|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483009|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483010|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483011|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
483012|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483013|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483014|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483015|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483016|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483017|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483018|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483019|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483020|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483021|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483022|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483023|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
483024|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483025|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483026|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483027|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483028|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483029|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483030|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483031|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483032|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483033|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483034|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483035|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
483036|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483037|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483038|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483039|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483040|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483041|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483042|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483043|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483044|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483045|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483046|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483047|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
483048|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483049|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483819|NCT00792116|O1|Outcome|Gum Chewing|
483050|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483051|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483052|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483053|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483054|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483055|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483056|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483057|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483058|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483059|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
483060|NCT00793793|E12|Reported Event|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483061|NCT00793793|E11|Reported Event|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483062|NCT00793793|E10|Reported Event|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483063|NCT00793793|E9|Reported Event|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
483064|NCT00793793|E8|Reported Event|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483065|NCT00793793|E7|Reported Event|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483066|NCT00793793|E6|Reported Event|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
483067|NCT00793793|E5|Reported Event|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483068|NCT00793793|E4|Reported Event|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483069|NCT00793793|E3|Reported Event|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
483070|NCT00793793|E2|Reported Event|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
483071|NCT00793793|E1|Reported Event|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
483072|NCT00793780|B3|Baseline|Total|Total of all reporting groups
483073|NCT00793780|B2|Baseline|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483074|NCT00793780|B1|Baseline|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483075|NCT00793780|P2|Participant Flow|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483076|NCT00793780|P1|Participant Flow|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483077|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483078|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483079|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483080|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483081|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483082|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483083|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483084|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483085|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483086|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483087|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483088|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483089|NCT00793780|E2|Reported Event|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
483090|NCT00793780|E1|Reported Event|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
483091|NCT00793650|B3|Baseline|Total|Total of all reporting groups
483092|NCT00793650|B2|Baseline|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483093|NCT00793650|B1|Baseline|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483094|NCT00793650|P2|Participant Flow|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483141|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
483095|NCT00793650|P1|Participant Flow|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483096|NCT00793650|O2|Outcome|Bortezomib After Melphalan|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483097|NCT00793650|O1|Outcome|Bortezomib Before Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483098|NCT00793650|O2|Outcome|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483099|NCT00793650|O1|Outcome|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483100|NCT00793650|E2|Reported Event|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483101|NCT00793650|E1|Reported Event|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
483102|NCT00793624|B5|Baseline|Total|Total of all reporting groups
483103|NCT00793624|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483104|NCT00793624|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483105|NCT00793624|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483106|NCT00793624|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483107|NCT00793624|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483108|NCT00793624|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483109|NCT00793624|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483110|NCT00793624|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483111|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483112|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483113|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483114|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483115|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483116|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483117|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483118|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483119|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483120|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483121|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483122|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483123|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483124|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483125|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483126|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483127|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483128|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483129|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483130|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483131|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483132|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483133|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483134|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483135|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
483136|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
483137|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
483138|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
483139|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
483140|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
483142|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
483143|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
483144|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
483145|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
483146|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
483147|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
483148|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
483149|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
483150|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
483151|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
483152|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
483153|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
483154|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
483155|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
483156|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
483157|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
483158|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
483159|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483160|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483161|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483162|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483163|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483164|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483165|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483166|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483167|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483168|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483169|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483170|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483171|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483172|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483173|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483174|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483175|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483176|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483177|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483178|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483179|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483180|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483181|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483182|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483183|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483184|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483185|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483186|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483187|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483188|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483189|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483190|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483191|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483192|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483193|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483194|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483195|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483196|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483197|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483198|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483199|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483200|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483201|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483202|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483203|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483204|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483205|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483206|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483207|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483208|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483209|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483210|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483211|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483212|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483213|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483214|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483215|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483216|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483217|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483218|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483219|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483220|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483221|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483222|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483223|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483224|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483225|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483226|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483227|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483228|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483229|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483230|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483231|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483232|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483233|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483234|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483235|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483236|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483237|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483238|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483239|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483240|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483241|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483242|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483243|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483244|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483245|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483246|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483247|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483248|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483249|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483250|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483251|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483252|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483253|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483254|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483255|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483256|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483257|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483258|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483259|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483260|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483261|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483262|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483263|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483264|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483265|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483266|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483267|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483268|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483269|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483270|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483271|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483272|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483273|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483274|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483275|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483276|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483277|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483278|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483279|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483280|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483281|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483282|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483283|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483284|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483285|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483286|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483287|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483288|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483289|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483290|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483291|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483292|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483293|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483294|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483295|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483296|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483297|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483298|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483299|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483300|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483301|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483302|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483303|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483304|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483305|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483306|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483307|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483308|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483309|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483310|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483311|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483312|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483313|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483314|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483315|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483316|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483317|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483318|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483319|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483320|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483321|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483322|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483323|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483324|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483325|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483326|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483327|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483328|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483329|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483330|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483331|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483332|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483333|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483334|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483335|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483336|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483337|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483338|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483339|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483340|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483341|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483342|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483343|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483344|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483345|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483346|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483347|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483348|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483349|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483350|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483351|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483352|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483353|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483354|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483355|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483356|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483357|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483358|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483359|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483360|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483361|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483362|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483363|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483364|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483365|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483366|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483367|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483368|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483369|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483370|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483371|NCT00793624|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
483372|NCT00793624|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
483373|NCT00793624|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
483374|NCT00793624|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
483375|NCT00793611|B3|Baseline|Total|Total of all reporting groups
483376|NCT00793611|B2|Baseline|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
483378|NCT00793611|P2|Participant Flow|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
483379|NCT00793611|P1|Participant Flow|Behavioral Therapy Standard Care|received 3 behavioral therapy session
483380|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
483381|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
483382|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
483383|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
483384|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
483385|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
483386|NCT00793611|E2|Reported Event|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
483387|NCT00793611|E1|Reported Event|Behavioral Therapy Standard Care|received 3 behavioral therapy session
483388|NCT00793585|B3|Baseline|Total|Total of all reporting groups
483389|NCT00793585|B2|Baseline|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
483390|NCT00793585|B1|Baseline|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
483391|NCT00793585|P2|Participant Flow|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
483392|NCT00793585|P1|Participant Flow|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
483393|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
483394|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
483395|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
483396|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
483397|NCT00793585|E2|Reported Event|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
483398|NCT00793585|E1|Reported Event|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
483399|NCT00793572|B1|Baseline|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483400|NCT00793572|P1|Participant Flow|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483419|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483420|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
484100|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
483401|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483402|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483403|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483404|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483405|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483406|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483407|NCT00793572|E1|Reported Event|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
483408|NCT00793546|B3|Baseline|Total|Total of all reporting groups
483409|NCT00793546|B2|Baseline|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483410|NCT00793546|B1|Baseline|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483411|NCT00793546|P2|Participant Flow|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483412|NCT00793546|P1|Participant Flow|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483413|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483414|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483415|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483416|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483417|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483418|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483524|NCT00793325|O1|Outcome|Mild SGA|Participants with mild SGA taking somatropin for SGA according to Japanese package insert.
483421|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483422|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483423|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483424|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483425|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483426|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483427|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483428|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483429|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483430|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483431|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483432|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483433|NCT00793546|O2|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483434|NCT00793546|O1|Outcome|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483435|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
483436|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483437|NCT00793546|E2|Reported Event|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483438|NCT00793546|E1|Reported Event|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
483439|NCT00793520|B3|Baseline|Total|Total of all reporting groups
483440|NCT00793520|B2|Baseline|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
483441|NCT00793520|B1|Baseline|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
483442|NCT00793520|P2|Participant Flow|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
483443|NCT00793520|P1|Participant Flow|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
483444|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
483445|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
483446|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
483447|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
483448|NCT00793520|E2|Reported Event|Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
483449|NCT00793520|E1|Reported Event|Milnacipran|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
483450|NCT00793455|B3|Baseline|Total|Total of all reporting groups
483451|NCT00793455|B2|Baseline|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
483452|NCT00793455|B1|Baseline|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
483453|NCT00793455|P2|Participant Flow|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
483454|NCT00793455|P1|Participant Flow|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
483455|NCT00793455|O2|Outcome|Intervention Group|Received outreach intervention
483456|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
483457|NCT00793455|O2|Outcome|Intervention Group|Received Educational Outreach
483458|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
483459|NCT00793455|E2|Reported Event|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
483460|NCT00793455|E1|Reported Event|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
483461|NCT00793403|B1|Baseline|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483462|NCT00793403|P1|Participant Flow|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483463|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483464|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483465|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483466|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483467|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483468|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483469|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483470|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483471|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483472|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483473|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483474|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483475|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483525|NCT00793325|O2|Outcome|Female|Female Participants taking somatropin for SGA according to Japanese package insert.
483526|NCT00793325|O1|Outcome|Male|Male Participants taking somatropin for SGA according to Japanese package insert.
483476|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483477|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483478|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483479|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483480|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483481|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483482|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483483|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483484|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483485|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483486|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483487|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483488|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483489|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483490|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483491|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483492|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483493|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483494|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483495|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483527|NCT00793325|O2|Outcome|>=15 Years|Participants 15 years of age or older when taking somatropin for SGA according to Japanese package insert.
483496|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483497|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483498|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483499|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483500|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483501|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483502|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483503|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483504|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483505|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483506|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483507|NCT00793403|E1|Reported Event|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
483508|NCT00793325|B1|Baseline|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
483509|NCT00793325|P1|Participant Flow|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
483510|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the height SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
483511|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the growth rate SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
483512|NCT00793325|O2|Outcome|Participants Without Concomitant Drug(s)|Participants taking no concomitant drugs while taking somatropin for SGA according to Japanese package insert.
483513|NCT00793325|O1|Outcome|Participants With Concomitant Drug(s)|Participants taking concomitant drug(s) while taking somatropin for SGA according to Japanese package insert.
483514|NCT00793325|O2|Outcome|Participants Without Renal Impairment|Participants without renal impairment taking somatropin for SGA according to Japanese package insert.
483515|NCT00793325|O1|Outcome|Participants With Renal Impairment|Participants with renal impairment taking somatropin for SGA according to Japanese package insert.
483516|NCT00793325|O2|Outcome|Participants Without Hepatic Function Disorder|Participants without hepatic function disorder taking somatropin for SGA according to Japanese package insert.
483517|NCT00793325|O1|Outcome|Participants With Hepatic Function Disorder|Participants with hepatic function disorder taking somatropin for SGA according to Japanese package insert.
483518|NCT00793325|O2|Outcome|Participants Without Complication(s)|Participants without complications while taking somatropin for SGA according to Japanese package insert.
483519|NCT00793325|O1|Outcome|Participants With Complication(s)|Participants with complication(s) while taking somatropin for SGA according to Japanese package insert.
483520|NCT00793325|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for SGA according to Japanese package insert.
483521|NCT00793325|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for SGA according to Japanese package insert.
483522|NCT00793325|O3|Outcome|Severe SGA|Participants with severe SGA taking somatropin for SGA according to Japanese package insert.
483523|NCT00793325|O2|Outcome|Moderate SGA|Participants with moderate SGA taking somatropin for SGA according to Japanese package insert.
483528|NCT00793325|O1|Outcome|<15 Years|Participants younger than 15 years of age when taking somatropin for SGA according to Japanese package insert.
483529|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
483530|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
483531|NCT00793325|E1|Reported Event|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
483532|NCT00793182|B1|Baseline|1323-07-872|Study participants
483533|NCT00793182|P1|Participant Flow|1323-07-872|All participants
483534|NCT00793182|O1|Outcome|1323-07-872|Study participants
483535|NCT00793182|E1|Reported Event|1323-07-872|Study participants
483536|NCT00793169|B1|Baseline|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
483537|NCT00793169|P1|Participant Flow|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
483538|NCT00793169|O1|Outcome|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
483539|NCT00793169|E1|Reported Event|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
483540|NCT00793104|B1|Baseline|CR Plug|Placement of allograft CR Plug in primary injury site
483541|NCT00793104|P1|Participant Flow|CR Plug|Placement of allograft CR Plug in primary injury site
483542|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
483543|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
483544|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
483545|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
483546|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
483547|NCT00793104|E1|Reported Event|CR Plug|Placement of allograft CR Plug in primary injury site
483548|NCT00792948|B1|Baseline|Treatment|
483549|NCT00792948|P1|Participant Flow|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
483550|NCT00792948|O1|Outcome|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
483551|NCT00792948|O1|Outcome|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
483552|NCT00792948|O1|Outcome|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
483553|NCT00792948|E4|Reported Event|Dasatinib|Patients receive Single-Agent Dasatinib therapy PO every day for up to five years from original registration.
483554|NCT00792948|E3|Reported Event|Allogeneic Stem Cell Transplant|Patients who have an available sibling donor or a 10/10 matched unrelated donor will be removed from therapy and proceed directly to allogeneic stem cell transplant after achieving CR or CRi.
483555|NCT00792948|E2|Reported Event|Vincristine/Prednisone/Dasatinib|Patients receive vincristine IV on day 1, prednisone PO on days 1 to 5, and dasatinib PO on days 1 to 28 for up to 24 courses or until transplant is available.
483556|NCT00792948|E1|Reported Event|Induction/Consolidation|Patients receive up to 8 courses, alternating between hyper-CVAD plus dasatinib and high dose methotrexate and cytarabine plus dasatinib. There are nine possible induction/consolidation courses.
483557|NCT00792935|B3|Baseline|Total|Total of all reporting groups
483558|NCT00792935|B2|Baseline|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483602|NCT00792909|O3|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483859|NCT00791973|E1|Reported Event|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
483559|NCT00792935|B1|Baseline|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483560|NCT00792935|P2|Participant Flow|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483561|NCT00792935|P1|Participant Flow|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483562|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483563|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483564|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483565|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
483566|NCT00792935|E2|Reported Event|Glimepiride|All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
483567|NCT00792935|E1|Reported Event|MK-0941|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.
483568|NCT00792922|B5|Baseline|Total|Total of all reporting groups
483569|NCT00792922|B4|Baseline|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483570|NCT00792922|B3|Baseline|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483571|NCT00792922|B2|Baseline|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483572|NCT00792922|B1|Baseline|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483573|NCT00792922|P4|Participant Flow|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483574|NCT00792922|P3|Participant Flow|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483575|NCT00792922|P2|Participant Flow|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483576|NCT00792922|P1|Participant Flow|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483603|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
494836|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
483577|NCT00792922|O4|Outcome|80%-89% Coverage With Azithromycin: Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483578|NCT00792922|O3|Outcome|≥90% Coveage With Azithromycin, Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483579|NCT00792922|O2|Outcome|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483580|NCT00792922|O1|Outcome|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483581|NCT00792922|O4|Outcome|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483582|NCT00792922|O3|Outcome|≥90% Coveage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483583|NCT00792922|O2|Outcome|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483584|NCT00792922|O1|Outcome|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483585|NCT00792922|E4|Reported Event|80%-89% Coverage With Azithromycin : Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483586|NCT00792922|E3|Reported Event|≥90% Coverage With Azithromycin , Treatment Based|"Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%~In Niger, treatment will be every 6-months for children ages twelve and under.~Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months."
483587|NCT00792922|E2|Reported Event|80%-89% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483588|NCT00792922|E1|Reported Event|≥90% Coverage With Azithromycin Target|"Selected communities will receive mass treatment annually for three years.~Azithromycin: Comparison of community coverage rate"
483589|NCT00792909|B4|Baseline|Total|Total of all reporting groups
483590|NCT00792909|B3|Baseline|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483591|NCT00792909|B2|Baseline|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483592|NCT00792909|B1|Baseline|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483593|NCT00792909|P3|Participant Flow|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483594|NCT00792909|P2|Participant Flow|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483595|NCT00792909|P1|Participant Flow|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483596|NCT00792909|O3|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483597|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483598|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483599|NCT00792909|O3|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483600|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483601|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483692|NCT00792636|B2|Baseline|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483604|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483605|NCT00792909|O3|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483606|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483607|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483608|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483609|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483610|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483611|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483612|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483613|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483614|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483615|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483616|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483617|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483618|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483619|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483620|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483621|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483622|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483623|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483624|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483625|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483626|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483627|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483628|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483629|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483630|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483631|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483632|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483633|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483634|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483635|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
484101|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
483636|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483637|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483638|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483639|NCT00792909|O2|Outcome|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483640|NCT00792909|O1|Outcome|Synflorix™ Group 1|Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483641|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483642|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483643|NCT00792909|O1|Outcome|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483644|NCT00792909|E3|Reported Event|Unprimed Group|Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
483645|NCT00792909|E2|Reported Event|Synflorix™ Group 2|Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
483646|NCT00792909|E1|Reported Event|Synflorix™ Group 1|Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
483647|NCT00792805|B4|Baseline|Total|Total of all reporting groups
483648|NCT00792805|B3|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483649|NCT00792805|B2|Baseline|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483650|NCT00792805|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483651|NCT00792805|P3|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483652|NCT00792805|P2|Participant Flow|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483653|NCT00792805|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483654|NCT00792805|O3|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483655|NCT00792805|O2|Outcome|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483656|NCT00792805|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483657|NCT00792805|E3|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483658|NCT00792805|E2|Reported Event|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483693|NCT00792636|B1|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483694|NCT00792636|P3|Participant Flow|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483659|NCT00792805|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
483660|NCT00792701|B3|Baseline|Total|Total of all reporting groups
483661|NCT00792701|B2|Baseline|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV"
483662|NCT00792701|B1|Baseline|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.~Active surveillance: Patients undergo active monitoring"
483663|NCT00792701|P2|Participant Flow|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV"
483664|NCT00792701|P1|Participant Flow|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.~Active surveillance: Patients undergo active monitoring"
483665|NCT00792701|O1|Outcome|All Patients|All registered patients.
483666|NCT00792701|O1|Outcome|All Patients|All registered patients.
483667|NCT00792701|O1|Outcome|All Patients|All registered patients.
483668|NCT00792701|O1|Outcome|All Patients|All registered patients.
483669|NCT00792701|O1|Outcome|Gemcitabine Hydrochloride and Cisplatin|Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
483670|NCT00792701|O2|Outcome|Gemcitabine Hydrochloride and Cisplatin|"Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~Cisplatin: Given IV~Gemcitabine Hydrochloride: Given IV"
483671|NCT00792701|O1|Outcome|Active Monitoring|"Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks.~Active surveillance: Patients undergo active monitoring"
483672|NCT00792701|O1|Outcome|All Eligible Patients|All patients who received a treatment assignment within the prespecified timeframe.
483673|NCT00792701|E1|Reported Event|Gemcitabine Hydrochloride and Cisplatin|Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
483674|NCT00792688|B4|Baseline|Total|Total of all reporting groups
483675|NCT00792688|B3|Baseline|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483676|NCT00792688|B2|Baseline|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483677|NCT00792688|B1|Baseline|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483678|NCT00792688|P3|Participant Flow|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483679|NCT00792688|P2|Participant Flow|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483680|NCT00792688|P1|Participant Flow|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483681|NCT00792688|O3|Outcome|All Treatments Placebo|
483682|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
483683|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
483684|NCT00792688|O3|Outcome|All Treatments Placebo|
483685|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
483686|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
483687|NCT00792688|E3|Reported Event|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483688|NCT00792688|E2|Reported Event|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483689|NCT00792688|E1|Reported Event|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
483690|NCT00792636|B4|Baseline|Total|Total of all reporting groups
483691|NCT00792636|B3|Baseline|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483696|NCT00792636|P1|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483697|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483698|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483699|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483700|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483701|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483702|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483703|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483704|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483705|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483706|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483707|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483708|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483709|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483710|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483711|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483712|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483713|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483714|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483715|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483716|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483717|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483718|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483719|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483720|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483721|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483722|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483723|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483724|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483725|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483726|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483727|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483728|NCT00792636|O1|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483729|NCT00792636|E3|Reported Event|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
483730|NCT00792636|E2|Reported Event|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
483731|NCT00792636|E1|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
483732|NCT00792623|B1|Baseline|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483733|NCT00792623|P1|Participant Flow|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483734|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483735|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483736|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483737|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483738|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483739|NCT00792623|O1|Outcome|Varilrix Arm|
483740|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483999|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483741|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483742|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483743|NCT00792623|O1|Outcome|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483744|NCT00792623|E1|Reported Event|Varilrix Group|Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.
483745|NCT00792610|B1|Baseline|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
483746|NCT00792610|P1|Participant Flow|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
483747|NCT00792610|O1|Outcome|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
483748|NCT00792610|E1|Reported Event|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
483749|NCT00792428|B3|Baseline|Total|Total of all reporting groups
483750|NCT00792428|B2|Baseline|Sham-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.~Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue."
483751|NCT00792428|B1|Baseline|Real-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.~Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue"
483752|NCT00792428|P2|Participant Flow|Sham-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.~Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue."
483753|NCT00792428|P1|Participant Flow|Real-tDCS + PT-OT|"Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.~Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue"
483754|NCT00792428|O2|Outcome|Sham-tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
483755|NCT00792428|O1|Outcome|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
483756|NCT00792428|O2|Outcome|Sham-tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
483757|NCT00792428|O1|Outcome|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
483758|NCT00792428|E2|Reported Event|Sham tDCS + PT-OT|Subjects are receiving sham tDCS in a dual configuration over both motor regions for 30 minutes while they are also receiving PT-OT for 60 minutes
483759|NCT00792428|E1|Reported Event|Real-tDCS + PT-OT|Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total.
483760|NCT00792298|B1|Baseline|All Treated Participants|All randomized participants who received at least one dose of study treatment.
483761|NCT00792298|P8|Participant Flow|Placebo → Suvorexant 80 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.
483762|NCT00792298|P7|Participant Flow|Suvorexant 80 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
483763|NCT00792298|P6|Participant Flow|Placebo → Suvorexant 40 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
483764|NCT00792298|P5|Participant Flow|Suvorexant 40 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
483765|NCT00792298|P4|Participant Flow|Placebo → Suvorexant 20 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
483766|NCT00792298|P3|Participant Flow|Suvorexant 20 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
483767|NCT00792298|P2|Participant Flow|Placebo → Suvorexant 10 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
483768|NCT00792298|P1|Participant Flow|Suvorexant 10 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
483769|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
483770|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
483771|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
483772|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
483773|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
483774|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483775|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483776|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483777|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483778|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
483779|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483780|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483781|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483782|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483783|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
483784|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483785|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483786|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483787|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483788|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
483789|NCT00792298|E5|Reported Event|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483790|NCT00792298|E4|Reported Event|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483791|NCT00792298|E3|Reported Event|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483792|NCT00792298|E2|Reported Event|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
483793|NCT00792298|E1|Reported Event|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
483794|NCT00792259|B4|Baseline|Total|Total of all reporting groups
483795|NCT00792259|B3|Baseline|Glaucoma Subjects|Glaucoma subjects presented with pathology
483796|NCT00792259|B2|Baseline|Retinal Disease Subjects|Retinal Disease subjects with ocular pathology
483797|NCT00792259|B1|Baseline|Normal Subjects|Normal Subjects with no known ocular pathology
483798|NCT00792259|P3|Participant Flow|Glaucoma Subjects|Subjects presented with Glaucoma
483799|NCT00792259|P2|Participant Flow|Normal Subjects|Normal subjects with no known ocular pathology
483800|NCT00792259|P1|Participant Flow|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
483801|NCT00792259|O3|Outcome|Glaucoma Subjects|Subjects presented with glaucoma
483802|NCT00792259|O2|Outcome|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
483803|NCT00792259|O1|Outcome|Normal Subjects|Normal subjects with no known ocular pathology
483804|NCT00792259|E3|Reported Event|Glaucoma Subjects|Subjects presented with glaucoma
483805|NCT00792259|E2|Reported Event|Normal Subjects|Normal subjects with no known ocular pathology
483806|NCT00792259|E1|Reported Event|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
483807|NCT00792116|B3|Baseline|Total|Total of all reporting groups
483808|NCT00792116|B2|Baseline|Non-Gum Chewing|
483809|NCT00792116|B1|Baseline|Gum Chewing|
483810|NCT00792116|P2|Participant Flow|Non-Gum Chewing|
483811|NCT00792116|P1|Participant Flow|Gum Chewing|
483812|NCT00792116|O2|Outcome|Non-Gum Chewing|
483820|NCT00792103|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483821|NCT00792103|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483822|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483823|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483824|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483825|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483826|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483827|NCT00792103|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
483828|NCT00791999|B5|Baseline|Total|Total of all reporting groups
483829|NCT00791999|B4|Baseline|Placebo|Placebo given every 2 weeks
483830|NCT00791999|B3|Baseline|CDP870 400mg|400mg CDP870 given every 2 weeks
483831|NCT00791999|B2|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
483832|NCT00791999|B1|Baseline|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
483833|NCT00791999|P4|Participant Flow|Placebo|Placebo given every 2 weeks
483834|NCT00791999|P3|Participant Flow|CDP870 400mg|400mg CDP870 given every 2 weeks
483835|NCT00791999|P2|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
483836|NCT00791999|P1|Participant Flow|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
483837|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
483838|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
483839|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
483840|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
483841|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
483842|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
483843|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
483844|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
483845|NCT00791999|E4|Reported Event|Placebo|Placebo given every 2 weeks
483846|NCT00791999|E3|Reported Event|CDP870 400mg|400mg CDP870 given every 2 weeks
483847|NCT00791999|E2|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
483848|NCT00791999|E1|Reported Event|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
483849|NCT00791973|B3|Baseline|Total|Total of all reporting groups
483850|NCT00791973|B2|Baseline|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
483851|NCT00791973|B1|Baseline|Veramyst, Then Placbeo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
483852|NCT00791973|P2|Participant Flow|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
483853|NCT00791973|P1|Participant Flow|Veramyst, Then Placebo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
483854|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
483855|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
483856|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
483857|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
483858|NCT00791973|E2|Reported Event|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
483860|NCT00791934|B1|Baseline|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
483861|NCT00791934|P1|Participant Flow|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.
483862|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
483863|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
483864|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
483865|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
483866|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
483867|NCT00791934|E1|Reported Event|Stratus Microflow Ethmoid Spacer|Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
483868|NCT00791921|B3|Baseline|Total|Total of all reporting groups
483869|NCT00791921|B2|Baseline|Placebo|Placebo of CDP870
483870|NCT00791921|B1|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
483871|NCT00791921|P2|Participant Flow|Placebo|Placebo of CDP870
483872|NCT00791921|P1|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
483873|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
483874|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
483875|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
483876|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
483877|NCT00791921|E2|Reported Event|Placebo|Placebo of CDP870
483878|NCT00791921|E1|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
483879|NCT00791908|B1|Baseline|Subjects|
483880|NCT00791908|P1|Participant Flow|Subjects|
483881|NCT00791908|O3|Outcome|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
483882|NCT00791908|O2|Outcome|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
483883|NCT00791908|O1|Outcome|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
483884|NCT00791908|E3|Reported Event|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
483885|NCT00791908|E2|Reported Event|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
483886|NCT00791908|E1|Reported Event|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
483887|NCT00791817|B3|Baseline|Total|Total of all reporting groups
483888|NCT00791817|B2|Baseline|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
483889|NCT00791817|B1|Baseline|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
483890|NCT00791817|P2|Participant Flow|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
483891|NCT00791817|P1|Participant Flow|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
483892|NCT00791817|O2|Outcome|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
483893|NCT00791817|O1|Outcome|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
483894|NCT00791817|E2|Reported Event|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
483895|NCT00791817|E1|Reported Event|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
483896|NCT00791778|B3|Baseline|Total|Total of all reporting groups
483897|NCT00791778|B2|Baseline|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483898|NCT00791778|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483899|NCT00791778|P2|Participant Flow|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483900|NCT00791778|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483901|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483902|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483903|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483904|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483905|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483906|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483907|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483908|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483909|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483910|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483911|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483912|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483913|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483914|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483915|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483916|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483917|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483918|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483919|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483920|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483921|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483922|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483923|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483924|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483925|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483926|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483927|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483928|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483929|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483930|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483931|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483932|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483933|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483934|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483935|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483936|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483937|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483938|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483939|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483940|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483941|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483942|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483943|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483944|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483945|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483946|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483947|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483948|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483949|NCT00791778|E2|Reported Event|Placebo|Participants received 2 matching placebo tablets per oral twice daily
483950|NCT00791778|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
483951|NCT00791765|B3|Baseline|Total|Total of all reporting groups
483952|NCT00791765|B2|Baseline|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
483953|NCT00791765|B1|Baseline|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
483954|NCT00791765|P2|Participant Flow|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
483955|NCT00791765|P1|Participant Flow|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
483956|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
483957|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
483958|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
483959|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
483960|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
483961|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
483962|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
483963|NCT00791765|E2|Reported Event|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
483964|NCT00791765|E1|Reported Event|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
483965|NCT00791700|B5|Baseline|Total|Total of all reporting groups
483966|NCT00791700|B4|Baseline|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483967|NCT00791700|B3|Baseline|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
483968|NCT00791700|B2|Baseline|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483969|NCT00791700|B1|Baseline|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
483970|NCT00791700|P4|Participant Flow|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483971|NCT00791700|P3|Participant Flow|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
483972|NCT00791700|P2|Participant Flow|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483973|NCT00791700|P1|Participant Flow|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
483974|NCT00791700|O3|Outcome|Other Failure/Remainder|Participants with other failures
483975|NCT00791700|O2|Outcome|PDVF|Participants who meet the protocol-defined virologic failure
483976|NCT00791700|O1|Outcome|Response|Participants with plasma HIV-1 RNA <48 copies/mL
483977|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483978|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
483979|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483980|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
483981|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483982|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
483983|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483984|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
483985|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483986|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
483987|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483988|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
483989|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483990|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
483991|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483992|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
483993|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483994|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
483995|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
483996|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
483997|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
483998|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484000|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484001|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484002|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484003|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484004|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484005|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484006|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484007|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484008|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484009|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484010|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484011|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484012|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484013|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484014|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484015|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484016|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484017|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484018|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484019|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484020|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484021|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484022|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484023|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484024|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484025|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484026|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484027|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484028|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484029|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484030|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484031|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484032|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484033|NCT00791700|O8|Outcome|Cohort 4 (Grade 4)|>=12 - <18 years of age, MVC tablet formulation
484034|NCT00791700|O7|Outcome|Cohort 4 (Grade 3)|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484035|NCT00791700|O6|Outcome|Cohort 3 (Grade 4)|>=6- <12years of age, MVC liquid formulation
484036|NCT00791700|O5|Outcome|Cohort 3 (Grade 3)|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484037|NCT00791700|O4|Outcome|Cohort 2 (Grade 4)|>=6 - <12 years of age, MVC tablet formulation
484038|NCT00791700|O3|Outcome|Cohort 2 (Grade 3)|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484039|NCT00791700|O2|Outcome|Cohort 1 (Grade 4)|>=2 - <6 years of age, MVC liquid formulation
484040|NCT00791700|O1|Outcome|Cohort 1 (Grade 3)|>=2 - <6 years of age, MVC liquid formulation
484041|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484042|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484043|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484044|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484045|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484046|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484047|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484048|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484049|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484050|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484051|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484052|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
484053|NCT00791700|E4|Reported Event|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
484054|NCT00791700|E3|Reported Event|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
484055|NCT00791700|E2|Reported Event|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
484056|NCT00791700|E1|Reported Event|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
484057|NCT00791661|B4|Baseline|Total|Total of all reporting groups
484058|NCT00791661|B3|Baseline|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
484059|NCT00791661|B2|Baseline|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
484060|NCT00791661|B1|Baseline|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
484061|NCT00791661|P3|Participant Flow|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
484062|NCT00791661|P2|Participant Flow|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
484063|NCT00791661|P1|Participant Flow|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
484064|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
484065|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
484066|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484067|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484068|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484069|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484070|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484071|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484072|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484073|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484074|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484075|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
484076|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
484077|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484078|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484079|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484080|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484081|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484082|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484083|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484084|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484085|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484086|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484087|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484088|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484089|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484090|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484091|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484092|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484093|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484094|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484095|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484096|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484097|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484098|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484099|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484102|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484103|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484104|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484105|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484106|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484107|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484108|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484109|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484110|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484111|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484112|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484113|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484114|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484115|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484116|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484117|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484118|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484119|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484120|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484121|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484122|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484123|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484124|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484125|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484126|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484127|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484128|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484129|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484130|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484131|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
484132|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
484133|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484134|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484135|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484136|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484137|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484138|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484139|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484140|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484141|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484142|NCT00791661|E11|Reported Event|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
484143|NCT00791661|E10|Reported Event|Placebo|Participants received matching placebo to MK-1006
484144|NCT00791661|E9|Reported Event|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
484145|NCT00791661|E8|Reported Event|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
484146|NCT00791661|E7|Reported Event|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
484147|NCT00791661|E6|Reported Event|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
484148|NCT00791661|E5|Reported Event|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
484149|NCT00791661|E4|Reported Event|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
484150|NCT00791661|E3|Reported Event|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
484151|NCT00791661|E2|Reported Event|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
484152|NCT00791661|E1|Reported Event|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
484153|NCT00791648|B3|Baseline|Total|Total of all reporting groups
484154|NCT00791648|B2|Baseline|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484155|NCT00791648|B1|Baseline|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484156|NCT00791648|P2|Participant Flow|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484157|NCT00791648|P1|Participant Flow|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484541|NCT00790868|P1|Participant Flow|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
484158|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484159|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484160|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484161|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484162|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484163|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484164|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484165|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484166|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484167|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484168|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484169|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484170|NCT00791648|E2|Reported Event|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
484171|NCT00791648|E1|Reported Event|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
484172|NCT00791557|B1|Baseline|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
484173|NCT00791557|P1|Participant Flow|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
484174|NCT00791557|O1|Outcome|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
484175|NCT00791557|E1|Reported Event|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
484176|NCT00791518|B1|Baseline|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
484177|NCT00791518|P1|Participant Flow|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
484178|NCT00791518|O4|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
484179|NCT00791518|O3|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
484180|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
484181|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and a an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
484182|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
484183|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
484184|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
484185|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
484211|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484186|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
484187|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
484188|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
484189|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
484190|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 >=50%
484191|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 <50%
484192|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
484193|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
484194|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
484195|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <50%
484196|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
484197|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
484198|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
484199|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
484200|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
484201|NCT00791518|E1|Reported Event|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
484202|NCT00791492|B3|Baseline|Total|Total of all reporting groups
484203|NCT00791492|B2|Baseline|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484204|NCT00791492|B1|Baseline|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484205|NCT00791492|P2|Participant Flow|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484206|NCT00791492|P1|Participant Flow|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484207|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484208|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484209|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484210|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484542|NCT00790868|O2|Outcome|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
484212|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484213|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484214|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484215|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484216|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484217|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484218|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484219|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484220|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484221|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484222|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484223|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484224|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484225|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484226|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484227|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484228|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484229|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484230|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484231|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484232|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484233|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484234|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484235|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484236|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484237|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484238|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484239|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484240|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484241|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484242|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484243|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484244|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484245|NCT00791492|E2|Reported Event|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484246|NCT00791492|E1|Reported Event|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
484247|NCT00791479|B7|Baseline|Total|Total of all reporting groups
484248|NCT00791479|B6|Baseline|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484249|NCT00791479|B5|Baseline|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484250|NCT00791479|B4|Baseline|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484251|NCT00791479|B3|Baseline|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484252|NCT00791479|B2|Baseline|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484253|NCT00791479|B1|Baseline|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484254|NCT00791479|P6|Participant Flow|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484255|NCT00791479|P5|Participant Flow|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484256|NCT00791479|P4|Participant Flow|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484257|NCT00791479|P3|Participant Flow|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484258|NCT00791479|P2|Participant Flow|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484259|NCT00791479|P1|Participant Flow|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484260|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484261|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484262|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484263|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484264|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484265|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484266|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484267|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484268|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484269|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484270|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484271|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484543|NCT00790868|O1|Outcome|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
484272|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484273|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484274|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484275|NCT00791479|O6|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484276|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484277|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484278|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484279|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484280|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484281|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484282|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484283|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484284|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484285|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484286|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484287|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484288|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484289|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484290|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484291|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484292|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484293|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484294|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484295|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484296|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484297|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484298|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484299|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484300|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484301|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484302|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484303|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484304|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484305|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484306|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484307|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484308|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484309|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484544|NCT00790868|O2|Outcome|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
484545|NCT00790868|O1|Outcome|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
484310|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484311|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484312|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484313|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484314|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484315|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484316|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484317|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484318|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484319|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484320|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484321|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484322|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484323|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484324|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484325|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484326|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484327|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484328|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484329|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484330|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484331|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484332|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484333|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484334|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484335|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
484336|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484337|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484338|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484339|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484340|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484341|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
484342|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
484343|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
484344|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
484345|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
484346|NCT00791479|E6|Reported Event|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484347|NCT00791479|E5|Reported Event|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484348|NCT00791479|E4|Reported Event|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484349|NCT00791479|E3|Reported Event|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484350|NCT00791479|E2|Reported Event|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484351|NCT00791479|E1|Reported Event|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
484352|NCT00791388|B6|Baseline|Total|Total of all reporting groups
484353|NCT00791388|B5|Baseline|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
484354|NCT00791388|B4|Baseline|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
484355|NCT00791388|B3|Baseline|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
484356|NCT00791388|B2|Baseline|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
484357|NCT00791388|B1|Baseline|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
484358|NCT00791388|P5|Participant Flow|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
484359|NCT00791388|P4|Participant Flow|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
484360|NCT00791388|P3|Participant Flow|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
484361|NCT00791388|P2|Participant Flow|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
484362|NCT00791388|P1|Participant Flow|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
484363|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
484364|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
484365|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
484366|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
484367|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
484368|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
484369|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
484370|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
484371|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
484372|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
484373|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
484374|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
484375|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
484376|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
484546|NCT00790868|O2|Outcome|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
484377|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
484378|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
484379|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
484380|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
484381|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
484382|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
484383|NCT00791388|E5|Reported Event|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
484384|NCT00791388|E4|Reported Event|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
484385|NCT00791388|E3|Reported Event|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
484386|NCT00791388|E2|Reported Event|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
484387|NCT00791388|E1|Reported Event|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
484388|NCT00791336|B1|Baseline|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
484389|NCT00791336|P1|Participant Flow|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
484390|NCT00791336|O1|Outcome|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
484391|NCT00791336|O1|Outcome|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
484392|NCT00791336|O1|Outcome|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
484393|NCT00791336|E1|Reported Event|Nelfinavir|Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
484394|NCT00791323|B3|Baseline|Total|Total of all reporting groups
484395|NCT00791323|B2|Baseline|Soothe® XP|Mineral Oil Emollient
484396|NCT00791323|B1|Baseline|Ketorolac 0.4%|Ketorolac 0.4%
484397|NCT00791323|P2|Participant Flow|Soothe® XP|Mineral Oil Emollient
484398|NCT00791323|P1|Participant Flow|Ketorolac 0.4%|Ketorolac 0.4%
484399|NCT00791323|O2|Outcome|Soothe® XP|Mineral Oil Emollient
484400|NCT00791323|O1|Outcome|Ketorolac 0.4%|Ketorolac 0.4%
484401|NCT00791323|E2|Reported Event|Soothe® XP|Mineral Oil Emollient
484402|NCT00791323|E1|Reported Event|Ketorolac 0.4%|Ketorolac 0.4%
484403|NCT00791258|B1|Baseline|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484404|NCT00791258|P1|Participant Flow|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484405|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484406|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484407|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484408|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484409|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484410|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484411|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484412|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484473|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484413|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484414|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484415|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484416|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484417|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484418|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484419|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484420|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484421|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484422|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484423|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484424|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484425|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484426|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484427|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484428|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484429|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484430|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484431|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484432|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484433|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484434|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484435|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484436|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484437|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484438|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484439|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484440|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484547|NCT00790868|O1|Outcome|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
484548|NCT00790868|O2|Outcome|Placebo|"placebo-augmented CBT~placebo: 50mg"
484441|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484442|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484443|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484444|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484445|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484446|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484447|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484448|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484449|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484450|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484451|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484452|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484453|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484454|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484455|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484456|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484457|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484458|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484459|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484460|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484461|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484462|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484463|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484464|NCT00791258|E1|Reported Event|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
484465|NCT00791128|B1|Baseline|EndoBarrier Liner Device|Subjects implanted with the EndoBarrier for up to 12 months.
484466|NCT00791128|P1|Participant Flow|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
484467|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
484468|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
484469|NCT00791128|E1|Reported Event|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
484470|NCT00791102|B1|Baseline|All Study Participants|
484471|NCT00791102|P2|Participant Flow|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484472|NCT00791102|P1|Participant Flow|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
494837|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
484474|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484475|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484476|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484477|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484478|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484479|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484480|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484481|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484482|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484483|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484484|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484485|NCT00791102|E2|Reported Event|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484486|NCT00791102|E1|Reported Event|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
484487|NCT00791089|B3|Baseline|Total|Total of all reporting groups
484488|NCT00791089|B2|Baseline|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
484489|NCT00791089|B1|Baseline|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
484490|NCT00791089|P2|Participant Flow|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
484491|NCT00791089|P1|Participant Flow|Fish Oil, Ablation, Sinus Rhythm|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
484492|NCT00791089|O2|Outcome|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
484493|NCT00791089|O1|Outcome|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
484494|NCT00791089|E2|Reported Event|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
484495|NCT00791089|E1|Reported Event|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
484496|NCT00791076|B1|Baseline|All Study Participants|"2pmol/kg-1/min-1 saline infused continuously over 72 hours OR~2pmol/kg-1/min-1 PP infused continuously over 72 hours."
484497|NCT00791076|P1|Participant Flow|All Participants|"Saline~Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours.~OR~Pancreatic Polypeptide~Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
484498|NCT00791076|O2|Outcome|Pancreatic Polypeptide|"Pancreatic Polypeptide~Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
484499|NCT00791076|O1|Outcome|Saline Placebo|"Saline~Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
484500|NCT00791076|O2|Outcome|Pancreatic Polypeptide|"Pancreatic Polypeptide~Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
484501|NCT00791076|O1|Outcome|Saline Placebo|"Saline~Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
484502|NCT00791076|E2|Reported Event|Pancreatic Polypeptide|"Pancreatic Polypeptide~Pancreatic Polypeptide (PP): 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
484503|NCT00791076|E1|Reported Event|Saline Placebo|"Saline~Placebo: 2pmol/kg-1/min-1 PP or placebo infused continuously over 72 hours."
484514|NCT00790907|B1|Baseline|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
484549|NCT00790868|O1|Outcome|D-cycloserine|"DCS-augmented CBT~d-cycloserine: 50mg"
484550|NCT00790868|O2|Outcome|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
484504|NCT00791037|B1|Baseline|Treatment (Vaccine Therapy+ex Vivo T Cell Expansion)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
484505|NCT00791037|P1|Participant Flow|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
484506|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
484507|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
484508|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
484509|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
484510|NCT00791037|E1|Reported Event|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
484511|NCT00790907|B4|Baseline|Total|Total of all reporting groups
484512|NCT00790907|B3|Baseline|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484513|NCT00790907|B2|Baseline|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484515|NCT00790907|P3|Participant Flow|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484516|NCT00790907|P2|Participant Flow|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484517|NCT00790907|P1|Participant Flow|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
484518|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484519|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484520|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484521|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484522|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484523|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484524|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484525|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484539|NCT00790868|B1|Baseline|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
484540|NCT00790868|P2|Participant Flow|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
484526|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484527|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484528|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484529|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484530|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484531|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484532|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484533|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484534|NCT00790907|E3|Reported Event|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
484535|NCT00790907|E2|Reported Event|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
484536|NCT00790907|E1|Reported Event|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
484537|NCT00790868|B3|Baseline|Total|Total of all reporting groups
484538|NCT00790868|B2|Baseline|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
494838|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
484551|NCT00790868|O1|Outcome|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
484552|NCT00790868|E2|Reported Event|Placebo|"Placebo-augmented CBT~Placebo: 50mg"
484553|NCT00790868|E1|Reported Event|D-cycloserine|"DCS-augmented CBT~D-cycloserine: 50mg"
484554|NCT00790855|B1|Baseline|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
484555|NCT00790855|P1|Participant Flow|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
484556|NCT00790855|O1|Outcome|Bendamustine (75 mg/m^2)|75 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
484557|NCT00790855|O1|Outcome|Bendamustine|Starting dose 50 mg/m^2 intravenously, over 2 hours twice on Days 1-4 of every 4 week study cycle, with dose escalation of 25 mg/m^2 for 3 levels.
484558|NCT00790855|E1|Reported Event|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
484559|NCT00790803|B1|Baseline|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484560|NCT00790803|P1|Participant Flow|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484561|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484562|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484563|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484564|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484565|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484566|NCT00790803|E1|Reported Event|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
484567|NCT00790790|B4|Baseline|Total|Total of all reporting groups
484568|NCT00790790|B3|Baseline|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484569|NCT00790790|B2|Baseline|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484570|NCT00790790|B1|Baseline|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484571|NCT00790790|P3|Participant Flow|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484572|NCT00790790|P2|Participant Flow|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484573|NCT00790790|P1|Participant Flow|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484574|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484575|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484576|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484577|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484578|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484579|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484580|NCT00790790|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
484581|NCT00790790|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
495675|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
484582|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484583|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484584|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484585|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484586|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484587|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484588|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484589|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484590|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484591|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484592|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484593|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484594|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484595|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484596|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484597|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484598|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484599|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484600|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484601|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484602|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484603|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484604|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484605|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484606|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484607|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484608|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484609|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484610|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484611|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484612|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484613|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484614|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484615|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484616|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484617|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484618|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484619|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484620|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484621|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484622|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484623|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484624|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484625|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484659|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
484626|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484627|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484628|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484629|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484630|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484631|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484632|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484633|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484634|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484635|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484636|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484637|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484638|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484639|NCT00790790|E6|Reported Event|LY545694 105 mg Washout|1 week washout period from taking 105 mg LY545694
484640|NCT00790790|E5|Reported Event|LY545694 49 mg Washout|1 week washout period from taking 49 mg LY545694
484641|NCT00790790|E4|Reported Event|Placebo Washout|1 week washout period from taking placebo
484642|NCT00790790|E3|Reported Event|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
484643|NCT00790790|E2|Reported Event|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) twice daily (BID) oral (po) were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
484644|NCT00790790|E1|Reported Event|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
484645|NCT00790751|B5|Baseline|Total|Total of all reporting groups
484646|NCT00790751|B4|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
484647|NCT00790751|B3|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
484648|NCT00790751|B2|Baseline|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
484649|NCT00790751|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
484650|NCT00790751|P4|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
484651|NCT00790751|P3|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
484652|NCT00790751|P2|Participant Flow|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
484653|NCT00790751|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
484654|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
484655|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
484656|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
484657|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
484658|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
495676|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
484660|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
484661|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
484662|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
484663|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
484664|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
484665|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
484666|NCT00790751|E4|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
484667|NCT00790751|E3|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
484668|NCT00790751|E2|Reported Event|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
484669|NCT00790751|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
484670|NCT00790738|B3|Baseline|Total|Total of all reporting groups
484671|NCT00790738|B2|Baseline|Placebo|"placebo~placebo: placebo"
484672|NCT00790738|B1|Baseline|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
484673|NCT00790738|P2|Participant Flow|Placebo|"placebo~placebo: placebo"
484674|NCT00790738|P1|Participant Flow|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
484675|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
484676|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
484677|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
484678|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
484679|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
484680|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
484681|NCT00790738|E2|Reported Event|Placebo|"placebo~placebo: placebo"
484682|NCT00790738|E1|Reported Event|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
484683|NCT00790673|B5|Baseline|Total|Total of all reporting groups
484684|NCT00790673|B4|Baseline|Placebo|Placebo: Matching placebo capsules
484685|NCT00790673|B3|Baseline|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
484686|NCT00790673|B2|Baseline|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
484687|NCT00790673|B1|Baseline|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
484688|NCT00790673|P4|Participant Flow|Placebo|Placebo: Matching placebo capsules
484689|NCT00790673|P3|Participant Flow|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
484690|NCT00790673|P2|Participant Flow|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
484691|NCT00790673|P1|Participant Flow|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
484692|NCT00790673|O4|Outcome|Placebo|Placebo: Matching placebo capsules
484693|NCT00790673|O3|Outcome|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
484694|NCT00790673|O2|Outcome|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
484695|NCT00790673|O1|Outcome|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
484696|NCT00790673|E4|Reported Event|Placebo|Placebo: Matching placebo capsules
484697|NCT00790673|E3|Reported Event|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
484698|NCT00790673|E2|Reported Event|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
484699|NCT00790673|E1|Reported Event|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
484700|NCT00790647|B1|Baseline|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
484701|NCT00790647|P1|Participant Flow|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
484702|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
484703|NCT00790647|O1|Outcome|Stem Cell Transplantation With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
484704|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
484705|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
485001|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
484706|NCT00790647|E1|Reported Event|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
484707|NCT00790569|B4|Baseline|Total|Total of all reporting groups
484708|NCT00790569|B3|Baseline|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484709|NCT00790569|B2|Baseline|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484710|NCT00790569|B1|Baseline|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484711|NCT00790569|P3|Participant Flow|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484712|NCT00790569|P2|Participant Flow|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484713|NCT00790569|P1|Participant Flow|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484714|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484715|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484716|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484717|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484718|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484719|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484720|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484721|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484722|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484723|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484724|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484725|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484726|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484727|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484728|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484729|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
484730|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484731|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484732|NCT00790569|E3|Reported Event|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
485002|NCT00790023|O3|Outcome|Placebo|Placebo once daily
484733|NCT00790569|E2|Reported Event|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
484734|NCT00790569|E1|Reported Event|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
484735|NCT00790556|B1|Baseline|All Participants|All participants
484736|NCT00790556|P2|Participant Flow|Placebo Then MK8245|"During Treatment Period 1, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
484737|NCT00790556|P1|Participant Flow|MK8245 Then Placebo|"During Treatment Period 1, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
484738|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484739|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484740|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484741|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484742|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484743|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484744|NCT00790556|E2|Reported Event|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484745|NCT00790556|E1|Reported Event|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
484746|NCT00790452|B3|Baseline|Total|Total of all reporting groups
484747|NCT00790452|B2|Baseline|Group 2 (Placebo)|Tablet/day orally
484748|NCT00790452|B1|Baseline|Group 1 (Aspirin)|Aspirin 325 mg/day orally
484749|NCT00790452|P2|Participant Flow|Group 2 (Placebo)|Tablet/day orally
484750|NCT00790452|P1|Participant Flow|Group 1 (Aspirin)|Aspirin 325 mg/day orally
484751|NCT00790452|O2|Outcome|Group 2 (Placebo)|Tablet/day orally
484752|NCT00790452|O1|Outcome|Group 1 (Aspirin)|Aspirin 325 mg/day orally
484753|NCT00790452|E2|Reported Event|Group 2 (Placebo)|Tablet/day orally
484754|NCT00790452|E1|Reported Event|Group 1 (Aspirin)|Aspirin 325 mg/day orally
484755|NCT00790400|B3|Baseline|Total|Total of all reporting groups
484756|NCT00790400|B2|Baseline|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
484757|NCT00790400|B1|Baseline|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484758|NCT00790400|P2|Participant Flow|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
484759|NCT00790400|P1|Participant Flow|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484760|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
484761|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484762|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
484763|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484764|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
484765|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484766|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484767|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484768|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
484769|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484770|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
484771|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
484772|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484773|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
484774|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
484775|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484776|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
484777|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
484778|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484779|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
484780|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
484781|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
484782|NCT00790400|E3|Reported Event|Placebo Randomized/Never Crossed-over|Patients randomized to placebo who never crossed-over to Everolimus
484783|NCT00790400|E2|Reported Event|Placebo Randomized/Crossed Over to Everolimus|Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase
484784|NCT00790400|E1|Reported Event|Everolimus Randomized (Core & Ext)|Patients who were randomized and treated with Everolimus during the Core and Extension phase
484785|NCT00790335|B3|Baseline|Total|Total of all reporting groups
484786|NCT00790335|B2|Baseline|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484787|NCT00790335|B1|Baseline|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484788|NCT00790335|P2|Participant Flow|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio [INR} 2.0 - 3.0). Elastic compression stockings will be prescribed
484789|NCT00790335|P1|Participant Flow|A-Intervention|"Pharmacomechanical catheter-directed thrombolysis (PCDT) with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484790|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484791|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484792|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484793|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484794|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484795|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484796|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484884|NCT00790205|P2|Participant Flow|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484797|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484798|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484799|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484800|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484801|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484802|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484803|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484804|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484805|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484806|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484807|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484808|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484809|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484810|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484885|NCT00790205|P1|Participant Flow|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
485327|NCT00789750|B3|Baseline|Total|Total of all reporting groups
484811|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484812|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484813|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484814|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484815|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484816|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484817|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484818|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484819|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484820|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484821|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484822|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484823|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484824|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484886|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
495677|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
484825|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484826|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484827|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484828|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484829|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484830|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484831|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484832|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484833|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484834|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484835|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484836|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484837|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484838|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484887|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
495678|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
484839|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484840|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484841|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484842|NCT00790335|O2|Outcome|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484843|NCT00790335|O1|Outcome|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484844|NCT00790335|E2|Reported Event|B-Control|Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
484845|NCT00790335|E1|Reported Event|A-Intervention|"PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm~Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device."
484846|NCT00790296|B3|Baseline|Total|Total of all reporting groups
484847|NCT00790296|B2|Baseline|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
484848|NCT00790296|B1|Baseline|TRH Then Saline|TRH (0.5mg) given first followed by Saline
484849|NCT00790296|P2|Participant Flow|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
484850|NCT00790296|P1|Participant Flow|TRH Then Saline|TRH (0.5mg) given first followed by Saline
484851|NCT00790296|O2|Outcome|Saline|Saline given Intravenously
484852|NCT00790296|O1|Outcome|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
484853|NCT00790296|E2|Reported Event|Saline|Saline given intravenously
484854|NCT00790296|E1|Reported Event|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
484855|NCT00790270|B4|Baseline|Total|Total of all reporting groups
484856|NCT00790270|B3|Baseline|Ibuprophen Plus Cyclobenzaprine|
484857|NCT00790270|B2|Baseline|Ibuprofen|
484858|NCT00790270|B1|Baseline|Cyclobenzaprine|
484859|NCT00790270|P3|Participant Flow|Ibuprophen Plus Cyclobenzaprine|
484860|NCT00790270|P2|Participant Flow|Ibuprofen|
484861|NCT00790270|P1|Participant Flow|Cyclobenzaprine|
484862|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
484863|NCT00790270|O2|Outcome|Ibuprofen|
484864|NCT00790270|O1|Outcome|Cyclobenzaprine|
484865|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
484866|NCT00790270|O2|Outcome|Ibuprofen|
484867|NCT00790270|O1|Outcome|Cyclobenzaprine|
484868|NCT00790270|E3|Reported Event|Ibuprophen Plus Cyclobenzaprine|
484869|NCT00790270|E2|Reported Event|Ibuprofen|
484870|NCT00790270|E1|Reported Event|Cyclobenzaprine|
484871|NCT00790218|B1|Baseline|CF102|CF102: CF102 capsules twice daily by mouth
484872|NCT00790218|P3|Participant Flow|CF102 25mg|CF102: CF102 tablets were given orally twice daily
484873|NCT00790218|P2|Participant Flow|CF102 5mg|CF102: CF102 tablets were given orally twice daily
484874|NCT00790218|P1|Participant Flow|CF102 1mg|CF102: CF102 tablets were given orally twice daily
484875|NCT00790218|O3|Outcome|CF102 25mg|CF102 tablets given orally, BID
484876|NCT00790218|O2|Outcome|CF102 5mg|CF102 tablets given orally, BID
484877|NCT00790218|O1|Outcome|CF102 1mg|CF102 tablets given orally, BID
484878|NCT00790218|E3|Reported Event|CF102 25mg|CF102: CF102 capsules twice daily by mouth
484879|NCT00790218|E2|Reported Event|CF102 5mg|CF102: CF102 capsules twice daily by mouth
484880|NCT00790218|E1|Reported Event|CF102 1mg|CF102: CF102 capsules twice daily by mouth
484881|NCT00790205|B3|Baseline|Total|Total of all reporting groups
484882|NCT00790205|B2|Baseline|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484883|NCT00790205|B1|Baseline|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484888|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484889|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484890|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484891|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484892|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484893|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484894|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484895|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484896|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484897|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484898|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484899|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484900|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484901|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484902|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484903|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484904|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484905|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484906|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484907|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484908|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484909|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484910|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484911|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484912|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484913|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484914|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484915|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484916|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484917|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484918|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484919|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484920|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484921|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484922|NCT00790205|E2|Reported Event|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
484923|NCT00790205|E1|Reported Event|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
484924|NCT00790192|B5|Baseline|Total|Total of all reporting groups
484925|NCT00790192|B4|Baseline|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
484926|NCT00790192|B3|Baseline|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
484927|NCT00790192|B2|Baseline|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
484928|NCT00790192|B1|Baseline|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
484929|NCT00790192|P4|Participant Flow|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
484930|NCT00790192|P3|Participant Flow|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
484931|NCT00790192|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
484932|NCT00790192|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
484933|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
484934|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
484935|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
484936|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
484937|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
484938|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
484939|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
484940|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
484941|NCT00790192|E4|Reported Event|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
484942|NCT00790192|E3|Reported Event|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
484943|NCT00790192|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
484944|NCT00790192|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
484945|NCT00790062|B4|Baseline|Total|Total of all reporting groups
484946|NCT00790062|B3|Baseline|Oxytocin 80U/500cc|
484947|NCT00790062|B2|Baseline|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484948|NCT00790062|B1|Baseline|Oxytocin 10 Units/500cc|
484949|NCT00790062|P3|Participant Flow|Oxytocin 80U/500cc|
484950|NCT00790062|P2|Participant Flow|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484951|NCT00790062|P1|Participant Flow|Oxytocin 10 Units/500cc|
484952|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour~Oxytocin: See arms"
484953|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~Oxytocin: See arms"
484954|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour~Oxytocin: See arms"
484955|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
484956|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484957|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
484958|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
484959|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484960|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
484961|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
484962|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484963|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
484964|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
484965|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484966|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
484967|NCT00790062|O3|Outcome|Oxytocin 80U/500cc Over 1 Hour|
484968|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc Over 1 Hour|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484969|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc Over 1 Hour|
484970|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour~Oxytocin: See arms"
484971|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~Oxytocin: See arms"
484972|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour~Oxytocin: See arms"
484973|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|1 dose only for prophylaxsis given over 1 hour
484974|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~1 dose only for prophylaxsis given over 1 hour"
484975|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|1 dose only for prophylaxsis given over 1 hour
484976|NCT00790062|E3|Reported Event|Oxytocin 80U/500cc|
484977|NCT00790062|E2|Reported Event|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
484978|NCT00790062|E1|Reported Event|Oxytocin 10 Units/500cc|
484979|NCT00790036|B3|Baseline|Total|Total of all reporting groups
484980|NCT00790036|B2|Baseline|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
484981|NCT00790036|B1|Baseline|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
484982|NCT00790036|P2|Participant Flow|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
484983|NCT00790036|P1|Participant Flow|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
484984|NCT00790036|O2|Outcome|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
484985|NCT00790036|O1|Outcome|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
484986|NCT00790036|O2|Outcome|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
484987|NCT00790036|O1|Outcome|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
484988|NCT00790036|O2|Outcome|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
484989|NCT00790036|O1|Outcome|RAD001 (Everolimus)1|RAD001 10 mg (two 5 mg tablets), daily for 12 months
484990|NCT00790036|E3|Reported Event|All Patients|All Patients in the Everolimus and Placebo groups.
484991|NCT00790036|E2|Reported Event|Placebo|Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
484992|NCT00790036|E1|Reported Event|RAD001 (Everolimus)|RAD001 10 mg (two 5 mg tablets), daily for 12 months
484993|NCT00790023|B4|Baseline|Total|Total of all reporting groups
484994|NCT00790023|B3|Baseline|Placebo|Placebo once daily
484995|NCT00790023|B2|Baseline|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
484996|NCT00790023|B1|Baseline|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
484997|NCT00790023|P3|Participant Flow|Placebo|Placebo once daily
484998|NCT00790023|P2|Participant Flow|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
484999|NCT00790023|P1|Participant Flow|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485000|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485003|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485004|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485005|NCT00790023|O3|Outcome|Placebo|
485006|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485007|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485008|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485009|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485010|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485011|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485012|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485013|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485014|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485015|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485016|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485017|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485018|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485019|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485020|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485021|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485022|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485023|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485024|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485025|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485026|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485027|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485028|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485029|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485030|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485031|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485032|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485033|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485034|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485035|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485036|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485037|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485038|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485039|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485040|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485041|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485042|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485043|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485044|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485045|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485046|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485047|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485048|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485049|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485050|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485051|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485052|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485053|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485054|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485055|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485056|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485057|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485058|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485059|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485060|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485061|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485062|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485063|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485064|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485065|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485066|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485067|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485068|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485069|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485070|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485071|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485072|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485073|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485074|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485075|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485076|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485077|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485078|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485079|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485080|NCT00790023|O3|Outcome|Placebo|Placebo once daily
485081|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485082|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485083|NCT00790023|E3|Reported Event|Placebo|Placebo once daily
485084|NCT00790023|E2|Reported Event|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
485085|NCT00790023|E1|Reported Event|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
485086|NCT00789997|B3|Baseline|Total|Total of all reporting groups
485087|NCT00789997|B2|Baseline|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
485088|NCT00789997|B1|Baseline|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
485089|NCT00789997|P2|Participant Flow|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
485090|NCT00789997|P1|Participant Flow|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
485091|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
485092|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
485093|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
485094|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
485095|NCT00789997|E2|Reported Event|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
485096|NCT00789997|E1|Reported Event|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
485097|NCT00789958|B1|Baseline|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
485098|NCT00789958|P1|Participant Flow|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
485099|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
485100|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
485101|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
485102|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
485103|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
485104|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
485105|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
485328|NCT00789750|B2|Baseline|Placebo|Placebo tablets with pioglitazone therapy
485106|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
485107|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
485108|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
485109|NCT00789958|E1|Reported Event|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
485110|NCT00789880|B7|Baseline|Total|Total of all reporting groups
485111|NCT00789880|B6|Baseline|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
485112|NCT00789880|B5|Baseline|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
485113|NCT00789880|B4|Baseline|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
485114|NCT00789880|B3|Baseline|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485115|NCT00789880|B2|Baseline|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485116|NCT00789880|B1|Baseline|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
485117|NCT00789880|P6|Participant Flow|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
485118|NCT00789880|P5|Participant Flow|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
485119|NCT00789880|P4|Participant Flow|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
485120|NCT00789880|P3|Participant Flow|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485121|NCT00789880|P2|Participant Flow|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485122|NCT00789880|P1|Participant Flow|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
485123|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
485124|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485125|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
485126|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
485127|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
485128|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485129|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
485130|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485131|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
485132|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
485133|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
485329|NCT00789750|B1|Baseline|Colesevelam|Colesevelam tablets with pioglitazone therapy
485134|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485135|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
485136|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485137|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
485138|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
485139|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
485140|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485141|NCT00789880|E6|Reported Event|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
485142|NCT00789880|E5|Reported Event|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
485143|NCT00789880|E4|Reported Event|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
485144|NCT00789880|E3|Reported Event|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485145|NCT00789880|E2|Reported Event|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
485146|NCT00789880|E1|Reported Event|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
485147|NCT00789854|B4|Baseline|Total|Total of all reporting groups
485148|NCT00789854|B3|Baseline|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485149|NCT00789854|B2|Baseline|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485150|NCT00789854|B1|Baseline|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485151|NCT00789854|P3|Participant Flow|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485152|NCT00789854|P2|Participant Flow|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485153|NCT00789854|P1|Participant Flow|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485154|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485155|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485156|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485157|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485158|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485159|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485160|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485161|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485162|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485163|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485164|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485165|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485166|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485167|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485168|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485169|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485170|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485171|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485172|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485173|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485174|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485175|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485176|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485177|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485178|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485179|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485180|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485181|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485182|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485183|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485184|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485185|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485186|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485187|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485188|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485189|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485190|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485191|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485192|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485193|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485194|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485195|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485196|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485197|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485198|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485199|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485200|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485201|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485202|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485203|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485330|NCT00789750|P2|Participant Flow|Placebo|Placebo tablets with pioglitazone therapy
485204|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485205|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485206|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485207|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485208|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485209|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485210|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485211|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485212|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485213|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485214|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485215|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485216|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485217|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485218|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485219|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485220|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485221|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485222|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485223|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485224|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485225|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485226|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485227|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485228|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485229|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485230|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485231|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485232|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485233|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485234|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485235|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485236|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485237|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485238|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485239|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485331|NCT00789750|P1|Participant Flow|Colesevelam|Colesevelam tablets with pioglitazone therapy
485240|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485241|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485242|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485243|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485244|NCT00789854|E3|Reported Event|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
485245|NCT00789854|E2|Reported Event|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
485246|NCT00789854|E1|Reported Event|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
485247|NCT00789828|B3|Baseline|Total|Total of all reporting groups
485248|NCT00789828|B2|Baseline|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
485249|NCT00789828|B1|Baseline|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485250|NCT00789828|P2|Participant Flow|Placebo|Participants received oral dose of placebo matching to everolimus daily.
485251|NCT00789828|P1|Participant Flow|Everolimus|Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.
485252|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
485253|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485254|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485255|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485256|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485257|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485258|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485259|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485260|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485261|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
485262|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485263|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485264|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
485265|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485266|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485267|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485268|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485269|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485270|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485271|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
485332|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
495679|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
485272|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485273|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485274|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
485275|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485276|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
485277|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
485278|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
485279|NCT00789828|E3|Reported Event|Placebo Treated (Core Period)|Participants who received placebo in core period.
485280|NCT00789828|E2|Reported Event|Placebo (Core) Then Everolimus Treated (Extension Period)|Participants who received placebo in core period and then received evrolimus treatment in extension period.
485281|NCT00789828|E1|Reported Event|Everolimus Treated (Core and Extension Period)|Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.
485282|NCT00789815|B3|Baseline|Total|Total of all reporting groups
485283|NCT00789815|B2|Baseline|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485284|NCT00789815|B1|Baseline|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485285|NCT00789815|P2|Participant Flow|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485286|NCT00789815|P1|Participant Flow|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485287|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485288|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485289|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485290|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485291|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485292|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485293|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485294|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485295|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485296|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485297|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485298|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485299|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485300|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485301|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485302|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485303|NCT00789815|E2|Reported Event|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
485304|NCT00789815|E1|Reported Event|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
485305|NCT00789802|B4|Baseline|Total|Total of all reporting groups
485306|NCT00789802|B3|Baseline|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
485307|NCT00789802|B2|Baseline|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
485308|NCT00789802|B1|Baseline|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
485309|NCT00789802|P3|Participant Flow|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
485310|NCT00789802|P2|Participant Flow|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
485311|NCT00789802|P1|Participant Flow|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
485312|NCT00789802|O3|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
485313|NCT00789802|O2|Outcome|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
485314|NCT00789802|O1|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
485315|NCT00789802|O3|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
485316|NCT00789802|O2|Outcome|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
485317|NCT00789802|O1|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
485318|NCT00789802|O3|Outcome|Oral Placebo|oral placebo: oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
485319|NCT00789802|O2|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen: naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
485320|NCT00789802|O1|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol: transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
485321|NCT00789802|O3|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
485322|NCT00789802|O2|Outcome|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
485323|NCT00789802|O1|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
485324|NCT00789802|E3|Reported Event|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
485325|NCT00789802|E2|Reported Event|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
485326|NCT00789802|E1|Reported Event|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
485333|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485334|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485335|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485336|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485337|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485338|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485339|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485340|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485341|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485342|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485343|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485344|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485345|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485346|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485347|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485348|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485349|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485350|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485351|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485352|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485353|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485354|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485355|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485356|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485357|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485358|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485359|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485360|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485361|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485362|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485363|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485364|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485365|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485366|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485367|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485368|NCT00789750|O2|Outcome|Placebo|Placebo tablets with pioglitazone therapy
485369|NCT00789750|O1|Outcome|Colesevelam|Colesevelam tablets with pioglitazone therapy
485370|NCT00789750|E2|Reported Event|Placebo|Placebo tablets with pioglitazone therapy
485371|NCT00789750|E1|Reported Event|Colesevelam|Colesevelam tablets with pioglitazone therapy
485372|NCT00789737|B3|Baseline|Total|Total of all reporting groups
485373|NCT00789737|B2|Baseline|Placebo|"placebo~Placebo : placebo"
485374|NCT00789737|B1|Baseline|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485375|NCT00789737|P2|Participant Flow|Placebo|"placebo~Placebo : placebo"
485376|NCT00789737|P1|Participant Flow|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485377|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485378|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485379|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485380|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485381|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485382|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485383|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485384|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485385|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485386|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485387|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485388|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485389|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485390|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485391|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485392|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485393|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485394|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485395|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485396|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485397|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485398|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485399|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485400|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485401|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
485402|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485403|NCT00789737|E2|Reported Event|Placebo|"placebo~Placebo : placebo"
485404|NCT00789737|E1|Reported Event|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
485405|NCT00789724|B3|Baseline|Total|Total of all reporting groups
485406|NCT00789724|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
485407|NCT00789724|B1|Baseline|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
485408|NCT00789724|P2|Participant Flow|Placebo|0.67 ml of NaCl 0.9% solution
485409|NCT00789724|P1|Participant Flow|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
485410|NCT00789724|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
485411|NCT00789724|O1|Outcome|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
485412|NCT00789724|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
485413|NCT00789724|E1|Reported Event|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
485414|NCT00789698|B5|Baseline|Total|Total of all reporting groups
485415|NCT00789698|B4|Baseline|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
485416|NCT00789698|B3|Baseline|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
485417|NCT00789698|B2|Baseline|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
485418|NCT00789698|B1|Baseline|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
485419|NCT00789698|P4|Participant Flow|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
485420|NCT00789698|P3|Participant Flow|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
485421|NCT00789698|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
485422|NCT00789698|P1|Participant Flow|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
485423|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
485424|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
485425|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
485426|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
485427|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
485428|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or Lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
485429|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
485430|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
485431|NCT00789698|E4|Reported Event|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
485432|NCT00789698|E3|Reported Event|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
485433|NCT00789698|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
485434|NCT00789698|E1|Reported Event|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
485435|NCT00789685|B1|Baseline|Safety Population|Safety population includes all patients who received at least one dose of study medication, and was used for summaries of demographic and other baseline characteristics
485436|NCT00789685|P1|Participant Flow|Interferon Beta|"Interferon Beta~Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered."
485437|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
485438|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
485439|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
485440|NCT00789685|E1|Reported Event|Safety Population|Safety population includes all patients who received at least one dose of study medication
485441|NCT00789672|B3|Baseline|Total|Total of all reporting groups
485442|NCT00789672|B2|Baseline|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485443|NCT00789672|B1|Baseline|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485444|NCT00789672|P2|Participant Flow|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485445|NCT00789672|P1|Participant Flow|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485446|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485447|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485448|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485449|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485450|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485451|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485452|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485453|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485454|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485455|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485456|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485457|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485458|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485459|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485460|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485461|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485462|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485463|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485464|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485465|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485466|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485467|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485468|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485469|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485470|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485471|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485472|NCT00789672|E2|Reported Event|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485473|NCT00789672|E1|Reported Event|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
485474|NCT00789581|B3|Baseline|Total|Total of all reporting groups
485475|NCT00789581|B2|Baseline|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
485476|NCT00789581|B1|Baseline|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
485477|NCT00789581|P2|Participant Flow|AC/Paclitaxel|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by weekly paclitaxel for 12 weeks.~Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2"
485526|NCT00789477|B4|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
485478|NCT00789581|P1|Participant Flow|AC/Ixabepilone|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by ixabepilone every 3 weeks for 4 cycles (12 weeks).~Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2"
485479|NCT00789581|O2|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
485480|NCT00789581|O1|Outcome|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
485481|NCT00789581|O2|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
485482|NCT00789581|O1|Outcome|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
485483|NCT00789581|E2|Reported Event|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
485484|NCT00789581|E1|Reported Event|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
485485|NCT00789555|B4|Baseline|Total|Total of all reporting groups
485486|NCT00789555|B3|Baseline|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485487|NCT00789555|B2|Baseline|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485488|NCT00789555|B1|Baseline|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485489|NCT00789555|P3|Participant Flow|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485490|NCT00789555|P2|Participant Flow|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485491|NCT00789555|P1|Participant Flow|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485492|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485493|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485494|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485495|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485496|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485497|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485498|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485499|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485500|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485501|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485502|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485503|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485504|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485505|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485506|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485507|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485508|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485509|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485510|NCT00789555|E3|Reported Event|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
485511|NCT00789555|E2|Reported Event|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
485512|NCT00789555|E1|Reported Event|PATANASE|Two sprays in each nostril twice a day for up to 12 months
485513|NCT00789529|B3|Baseline|Total|Total of all reporting groups
485514|NCT00789529|B2|Baseline|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
485515|NCT00789529|B1|Baseline|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
485516|NCT00789529|P2|Participant Flow|2 - Opti-Free RepleniSH First, ReNu MultiPlus Second|Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
485517|NCT00789529|P1|Participant Flow|1 - ReNu MultiPlus First, Opti-Free RepleniSH Second|Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period
485518|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
485519|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
485520|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
485521|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
485522|NCT00789529|E2|Reported Event|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
485523|NCT00789529|E1|Reported Event|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
485524|NCT00789477|B6|Baseline|Total|Total of all reporting groups
485525|NCT00789477|B5|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
485741|NCT00789035|E3|Reported Event|Empagliflozin 10 mg qd|Patients receive 10 mg Empagliflozin in tablets once daily.
485527|NCT00789477|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
485528|NCT00789477|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
485529|NCT00789477|B1|Baseline|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
485530|NCT00789477|P5|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
485531|NCT00789477|P4|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
485532|NCT00789477|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52
485533|NCT00789477|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
485534|NCT00789477|P1|Participant Flow|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
485535|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
485536|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
485537|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
485538|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
485539|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
485540|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
485541|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
485542|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
485543|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
485544|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
485545|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
485546|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
485547|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
485548|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
485549|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
485550|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
485551|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
485552|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
485553|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
485554|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
485555|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
485556|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
485557|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
485558|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
485559|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
487789|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
485560|NCT00789477|E5|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
485561|NCT00789477|E4|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
485562|NCT00789477|E3|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
485563|NCT00789477|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
485564|NCT00789477|E1|Reported Event|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
485565|NCT00789438|B4|Baseline|Total|Total of all reporting groups
485566|NCT00789438|B3|Baseline|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
485567|NCT00789438|B2|Baseline|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
485568|NCT00789438|B1|Baseline|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
485569|NCT00789438|P3|Participant Flow|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
485570|NCT00789438|P2|Participant Flow|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
485571|NCT00789438|P1|Participant Flow|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
485572|NCT00789438|O3|Outcome|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
485573|NCT00789438|O2|Outcome|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
485574|NCT00789438|O1|Outcome|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
485575|NCT00789438|E3|Reported Event|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
485576|NCT00789438|E2|Reported Event|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
485577|NCT00789438|E1|Reported Event|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
485578|NCT00789373|B1|Baseline|Induction Pemetrexed + Cisplatin|pemetrexed plus cisplatin
485579|NCT00789373|P3|Participant Flow|Pemetrexed + Cisplatin Followed by Placebo|Following Induction, received placebo (normal saline [0.9% sodium chloride]) administered IV on Day 1 of every 21-day cycle plus Best Supportive Care until PD or treatment discontinuation.
485580|NCT00789373|P2|Participant Flow|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|Following Induction, received 500 mg/m^2 maintenance pemetrexed, IV, on Day 1 of each 21-day cycle plus Best Supportive Care until progressive disease (PD) or treatment discontinuation.
485581|NCT00789373|P1|Participant Flow|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
485582|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485583|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485584|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485585|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care
485586|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485587|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485588|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485589|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485590|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485591|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485592|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485593|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485594|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485595|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485596|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
485597|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485598|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485599|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485600|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
485601|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485602|NCT00789373|E3|Reported Event|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
485603|NCT00789373|E2|Reported Event|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
485604|NCT00789373|E1|Reported Event|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
485605|NCT00789321|B3|Baseline|Total|Total of all reporting groups
485606|NCT00789321|B2|Baseline|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
485607|NCT00789321|B1|Baseline|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
485608|NCT00789321|P2|Participant Flow|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
485609|NCT00789321|P1|Participant Flow|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
485610|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
485611|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
485612|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
485613|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
485614|NCT00789321|E2|Reported Event|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
485615|NCT00789321|E1|Reported Event|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
485616|NCT00789256|B3|Baseline|Total|Total of all reporting groups
485617|NCT00789256|B2|Baseline|Strata 2|will include patients who have received prior medical intervention for their disease.
485618|NCT00789256|B1|Baseline|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
485619|NCT00789256|P2|Participant Flow|Strata 2|Includes patients who have received prior medical intervention for their disease. Patients assigned to Strata 2 will receive Melphalan 2mg orally, once daily and Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
485620|NCT00789256|P1|Participant Flow|Strata 1|Includes patients who have not seen prior medical intervention for their disease. Patients assigned to Strata 1 will receive Melphalan 2mg orally, once daily and Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
485621|NCT00789256|O2|Outcome|Strata 2|will include patients who have received prior medical intervention for their disease.
485622|NCT00789256|O1|Outcome|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
485623|NCT00789256|E2|Reported Event|Strata 2|will include patients who have received prior medical intervention for their disease.
485624|NCT00789256|E1|Reported Event|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
485625|NCT00789191|B3|Baseline|Total|Total of all reporting groups
485626|NCT00789191|B2|Baseline|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485627|NCT00789191|B1|Baseline|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485628|NCT00789191|P2|Participant Flow|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485629|NCT00789191|P1|Participant Flow|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485630|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485631|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485632|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485633|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485634|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485635|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485636|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485637|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485638|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485639|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485640|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485641|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485642|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485643|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485644|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485645|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485646|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485647|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485648|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485649|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485650|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485651|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485652|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485653|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485654|NCT00789191|E2|Reported Event|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
485655|NCT00789191|E1|Reported Event|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
485656|NCT00789113|B1|Baseline|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
485657|NCT00789113|P1|Participant Flow|Extended Release Lamotrigine|"Extended Release Lamotrigine~Extended Release Lamotrigine"
485658|NCT00789113|O2|Outcome|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
485659|NCT00789113|O1|Outcome|Immediate Release (IR) Lamotrigine|Study population was on chronic IR lamotrigine therapy and first period of the study was a continuation of standard treatment with IR lamotrigine.
485660|NCT00789113|E1|Reported Event|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
485661|NCT00789074|B3|Baseline|Total|Total of all reporting groups
485662|NCT00789074|B2|Baseline|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
485663|NCT00789074|B1|Baseline|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
485664|NCT00789074|P2|Participant Flow|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
485665|NCT00789074|P1|Participant Flow|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
485666|NCT00789074|O2|Outcome|Placebo|
485667|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
485668|NCT00789074|O2|Outcome|Placebo|
485669|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
485670|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
485671|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
485672|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
485673|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
485674|NCT00789074|O2|Outcome|Placebo|
485675|NCT00789074|O1|Outcome|Varenicline|
485676|NCT00789074|O2|Outcome|Placebo|
485677|NCT00789074|O1|Outcome|Varenicline|
485678|NCT00789074|E2|Reported Event|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
485679|NCT00789074|E1|Reported Event|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
485680|NCT00789035|B6|Baseline|Total|Total of all reporting groups
485681|NCT00789035|B5|Baseline|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485682|NCT00789035|B4|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485683|NCT00789035|B3|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485684|NCT00789035|B2|Baseline|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485685|NCT00789035|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485686|NCT00789035|P5|Participant Flow|Metformin OL|Patients were to take a open-label (OL) dose of 500 mg Metformin twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485687|NCT00789035|P4|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485688|NCT00789035|P3|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485689|NCT00789035|P2|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485690|NCT00789035|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485691|NCT00789035|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485692|NCT00789035|O2|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485693|NCT00789035|O1|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485694|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485695|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485696|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485697|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485698|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485699|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485700|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485701|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485702|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485703|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485704|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485705|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485706|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485707|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485708|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485709|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485710|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485711|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485712|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485713|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485714|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485715|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485716|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485717|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485718|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485719|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485720|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485721|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485722|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485723|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485724|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485725|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485726|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485727|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485728|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485729|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485730|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485731|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485732|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485733|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485734|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485735|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
485736|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
485737|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485738|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485739|NCT00789035|E5|Reported Event|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
485740|NCT00789035|E4|Reported Event|Empagliflozin 25 mg qd|Patients receive 25 mg Empagliflozin in tablets once daily.
485742|NCT00789035|E2|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
485743|NCT00789035|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
485744|NCT00788957|B5|Baseline|Total|Total of all reporting groups
485745|NCT00788957|B4|Baseline|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485746|NCT00788957|B3|Baseline|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485747|NCT00788957|B2|Baseline|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485748|NCT00788957|B1|Baseline|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485749|NCT00788957|P6|Participant Flow|Part 3: Ganitumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
485750|NCT00788957|P5|Participant Flow|Part 3: Rilotumumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
485751|NCT00788957|P4|Participant Flow|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485752|NCT00788957|P3|Participant Flow|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485753|NCT00788957|P2|Participant Flow|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485754|NCT00788957|P1|Participant Flow|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485755|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485756|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485757|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485758|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485759|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485760|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485761|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485762|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485763|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485764|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485765|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485766|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485767|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485768|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485769|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485770|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485771|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485772|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485773|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485774|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485775|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485776|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485777|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485778|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485779|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485780|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485781|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485782|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485783|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485784|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485785|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485786|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485787|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485788|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485789|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485790|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485791|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485792|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485793|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485794|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485795|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485796|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485797|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485798|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485856|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
485799|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485800|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485801|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485802|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485803|NCT00788957|E4|Reported Event|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485804|NCT00788957|E3|Reported Event|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485805|NCT00788957|E2|Reported Event|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485806|NCT00788957|E1|Reported Event|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
485807|NCT00788892|B3|Baseline|Total|Total of all reporting groups
485808|NCT00788892|B2|Baseline|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485809|NCT00788892|B1|Baseline|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485810|NCT00788892|P2|Participant Flow|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485811|NCT00788892|P1|Participant Flow|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485812|NCT00788892|O2|Outcome|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485813|NCT00788892|O1|Outcome|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485814|NCT00788892|O2|Outcome|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485815|NCT00788892|O1|Outcome|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485816|NCT00788892|O2|Outcome|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485817|NCT00788892|O1|Outcome|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485818|NCT00788892|O2|Outcome|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485819|NCT00788892|O1|Outcome|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485820|NCT00788892|O2|Outcome|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485821|NCT00788892|O1|Outcome|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485822|NCT00788892|O2|Outcome|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
485823|NCT00788892|O1|Outcome|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485824|NCT00788892|E2|Reported Event|Arm B: Cytarabine + Daunorubicin|First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
487790|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
485825|NCT00788892|E1|Reported Event|Arm A: CPX-351|First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
485826|NCT00788775|B3|Baseline|Total|Total of all reporting groups
485827|NCT00788775|B2|Baseline|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485828|NCT00788775|B1|Baseline|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485829|NCT00788775|P2|Participant Flow|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485830|NCT00788775|P1|Participant Flow|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485831|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485832|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485833|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485834|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485835|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485836|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485837|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485838|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485839|NCT00788775|E2|Reported Event|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485840|NCT00788775|E1|Reported Event|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
485841|NCT00788710|B4|Baseline|Total|Total of all reporting groups
485842|NCT00788710|B3|Baseline|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
485843|NCT00788710|B2|Baseline|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
485844|NCT00788710|B1|Baseline|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
485845|NCT00788710|P3|Participant Flow|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
485846|NCT00788710|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
485847|NCT00788710|P1|Participant Flow|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
485848|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
485849|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
485850|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
485851|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
485852|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
485853|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
485854|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
485855|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
495680|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
485857|NCT00788710|E3|Reported Event|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
485858|NCT00788710|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
485859|NCT00788710|E1|Reported Event|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
485860|NCT00788697|B1|Baseline|ITD Population|All patients who received SonoVue and enrolled in the efficacy phase, had a definite final diagnosis from truth standard and unenhanced and SonoVue-enhanced ultrasonography available
485861|NCT00788697|P1|Participant Flow|Safety Population|"Interventions included SonoVue administration, unenhanced and SonoVue-enhanced ultrasound and definitive truth standard diagnosis.~Any patient who received SonoVue, training or efficacy phase, regardless of availability of ultrasonography or truth standard, is included in the Safety Population. Twelve patients with “No study drug administered” are not included in the Safety Population.~From 337 patients in the Safety Population, 74 patients enrolled in the training phase were excluded from efficacy analysis, and the Completed patients include efficacy phase patients who underwent SonoVue-enhanced ultrasound (SonoVue CE-US), unenhanced ultrasound (UE-US),and had definite truth standard diagnosis available."
485862|NCT00788697|O2|Outcome|CE-US|CE-US Inter-reader agreement
485863|NCT00788697|O1|Outcome|UE-US|UE-US Inter-reader agreement
485864|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
485865|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
485866|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
485867|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
485868|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
485869|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
485870|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
485871|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
485872|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
485873|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
485874|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
485875|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
485876|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
485877|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
485878|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
485879|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
485880|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
485881|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
485882|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
485883|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
485884|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
485885|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
485886|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
485887|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
485888|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
485889|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
485890|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
485891|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
485892|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
485893|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
485894|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
485895|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
485896|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
485897|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
485898|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
485899|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
485900|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
485901|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
485902|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
485903|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
485904|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
485905|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 unenhanced (UE) US assessment
485906|NCT00788697|E1|Reported Event|Safety Population|"Interventions included SonoVue administration, unenhanced and SonoVue-enhanced ultrasound and definitive truth standard diagnosis.~Any patient who received SonoVue, training or efficacy phase, regardless of availability of ultrasonography or truth standard, is included in the Safety Population. Twelve patients with “No study drug administered” are not included in the Safety Population.~Of 349 patients who started the study, 12 patients had No study drug administered and are not included and 337 received SonoVue and are included in the Safety Population."
485907|NCT00788593|B1|Baseline|Entire Study Population|Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose first.
485950|NCT00788255|E3|Reported Event|32.9 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
495681|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
485908|NCT00788593|P3|Participant Flow|EUR-1008 (APT-1008) Low Dose, Then High Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
485909|NCT00788593|P2|Participant Flow|EUR-1008 (APT-1008) High Dose, Then Low Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
485910|NCT00788593|P1|Participant Flow|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
485911|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485912|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485913|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485914|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485915|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485916|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485917|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
485918|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485919|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485920|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
485921|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485922|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485951|NCT00788255|E2|Reported Event|30.1 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
495682|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
485923|NCT00788593|E3|Reported Event|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485924|NCT00788593|E2|Reported Event|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
485925|NCT00788593|E1|Reported Event|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
485926|NCT00788372|B1|Baseline|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485927|NCT00788372|P1|Participant Flow|Fentanyl|Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485928|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485929|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485930|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485931|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485932|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485933|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485934|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485935|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485936|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485937|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485938|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485939|NCT00788372|E1|Reported Event|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
485952|NCT00788255|E1|Reported Event|22.5 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
485940|NCT00788255|B1|Baseline|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485941|NCT00788255|P1|Participant Flow|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485942|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485943|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485944|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485945|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485946|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485947|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485948|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
485949|NCT00788255|E4|Reported Event|0 μU/mL Exogenous Oxytocin|Thromboelastography on native blood sample.
485953|NCT00788073|B3|Baseline|Total|Total of all reporting groups
485954|NCT00788073|B2|Baseline|Placebo|placebo variable dose (same flexible dose titration protocol) bid to tid, oral, 4weeks
485955|NCT00788073|B1|Baseline|STX209|STX209 Variable dose, 1mg bid to 10mg tid, oral capsules, 4weeks
485956|NCT00788073|P2|Participant Flow|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
485957|NCT00788073|P1|Participant Flow|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
485958|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
485959|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
485960|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
485961|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
485962|NCT00788073|E2|Reported Event|Placebo|variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
485963|NCT00788073|E1|Reported Event|STX209|STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
485964|NCT00788008|B3|Baseline|Total|Total of all reporting groups
485965|NCT00788008|B2|Baseline|Propofol|Total intravenous anesthesia with propofol
485966|NCT00788008|B1|Baseline|Isoflurane|Inhalational anesthesia with isoflurane
485967|NCT00788008|P2|Participant Flow|Propofol|Total intravenous anesthesia with propofol
485968|NCT00788008|P1|Participant Flow|Isoflurane|Inhalational anesthesia with isoflurane
485969|NCT00788008|O2|Outcome|Propofol|Total intravenous anesthesia with propofol
485970|NCT00788008|O1|Outcome|Isoflurane|Inhalational anesthesia with isoflurane
485971|NCT00788008|E2|Reported Event|Propofol|Total intravenous anesthesia with propofol
485972|NCT00788008|E1|Reported Event|Isoflurane|Inhalational anesthesia with isoflurane
485973|NCT00787943|B1|Baseline|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
485974|NCT00787943|P1|Participant Flow|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
485975|NCT00787943|O4|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
485976|NCT00787943|O3|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
485977|NCT00787943|O2|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
485978|NCT00787943|O1|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
485979|NCT00787943|E2|Reported Event|Benzoyl Peroxide 10.0% Cream: Formulation #2|Formulation #2 applied to one side of the face by all 10 subjects.
485980|NCT00787943|E1|Reported Event|Benzoyl Peroxide 10.0% Cream Formulation #1|Formulation #1 applied to one side of the face by all 10 subjects.
485981|NCT00787930|B1|Baseline|Naturalistic Treatment|
485982|NCT00787930|P1|Participant Flow|Naturalistic Treatment|Acutely manic subjects were treated using the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) expert consensus guidelines beginning with valproic acid (titrated to therapeutic levels) over a three week period. If there was a non-response to this intervention, then a subject would continue acute treatment using other interventions indicated by STEP-BD protocols. After stabilization, subjects were followed monthly up to a year's duration and treated using the STEP-BD expert consensus guidelines.
485983|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
485984|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
485985|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) <15 or Montgomery Asberg Depression Rating Scale (MADRS) scales <15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
485986|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
485987|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
485988|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
485989|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
485990|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
485991|NCT00787930|O2|Outcome|Non-Responders to Acute Treatment|Subjects in an acute manic episode who did not respond to treatment as measured by a YMRS >15 by week 3.
485992|NCT00787930|O1|Outcome|Responders to Acute Treatment|Subjects in an acute manic episode who responded to treatment as measured by a Young Mania Rating Scale (YMRS) <15 by week 3, which was the protocol-defined determination point for response to treatment.
485993|NCT00787930|E1|Reported Event|Naturalistic Treatment|Patients were treated acutely using expert consensus guidelines beginning with valproic acid. After stabilization, subjects were followed monthly up to a year's duration and treated using expert consensus guidelines. indicated.
485994|NCT00787917|B3|Baseline|Total|Total of all reporting groups
485995|NCT00787917|B2|Baseline|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
485996|NCT00787917|B1|Baseline|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
485997|NCT00787917|P2|Participant Flow|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
485998|NCT00787917|P1|Participant Flow|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
485999|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
486000|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
486001|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
486019|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
486020|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
486021|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
486154|NCT00787566|B3|Baseline|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
486002|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
486003|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
486004|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
486005|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
486006|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
486007|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
486008|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
486009|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
486010|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
486011|NCT00787917|E3|Reported Event|Open Label Omalizumab|Patients who completed double-blinded phase of the study, enrolled into 6 months open label phase and continued in the same regimen of omalizumab as they were during double-blinded phase. A maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
486012|NCT00787917|E2|Reported Event|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
486013|NCT00787917|E1|Reported Event|Blinded Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
486014|NCT00787904|B3|Baseline|Total|Total of all reporting groups
486015|NCT00787904|B2|Baseline|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
486016|NCT00787904|B1|Baseline|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
486017|NCT00787904|P2|Participant Flow|Surgical Control|Pre-menopausal women with or without surgery
486018|NCT00787904|P1|Participant Flow|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
486022|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
486023|NCT00787904|E2|Reported Event|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
486024|NCT00787904|E1|Reported Event|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
486025|NCT00787891|B3|Baseline|Total|Total of all reporting groups
486026|NCT00787891|B2|Baseline|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486027|NCT00787891|B1|Baseline|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486028|NCT00787891|P2|Participant Flow|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486029|NCT00787891|P1|Participant Flow|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486030|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486031|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486032|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486033|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486034|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486035|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486036|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486037|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486038|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486039|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486040|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486041|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486042|NCT00787891|E4|Reported Event|Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486043|NCT00787891|E3|Reported Event|Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486044|NCT00787891|E2|Reported Event|Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486045|NCT00787891|E1|Reported Event|Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
486046|NCT00787852|B3|Baseline|Total|Total of all reporting groups
486047|NCT00787852|B2|Baseline|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
486048|NCT00787852|B1|Baseline|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
486049|NCT00787852|P2|Participant Flow|Group 2: Dasatinib 70mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 70 mg daily~Maintenance x 2 years*"
486050|NCT00787852|P1|Participant Flow|Group 1: Dasatinib 50mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 50 mg daily~Maintenance x 2 years*"
486051|NCT00787852|O2|Outcome|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
486052|NCT00787852|O1|Outcome|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
486151|NCT00787605|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486152|NCT00787605|E1|Reported Event|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486053|NCT00787852|E2|Reported Event|Group 2|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~70 mg daily"
486054|NCT00787852|E1|Reported Event|Group 1|DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily 50 mg daily
486055|NCT00787839|B1|Baseline|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.
486056|NCT00787839|P1|Participant Flow|Group 1|"Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.~Glucose challenge test: At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.~Glucose tolerance test: Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c."
486057|NCT00787839|O8|Outcome|GCTcap - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTcap screening test
486058|NCT00787839|O7|Outcome|GCTpl - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTpl screening test
486059|NCT00787839|O6|Outcome|GCTcap - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTcap screening test
486060|NCT00787839|O5|Outcome|GCTpl - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTpl screening test
486061|NCT00787839|O4|Outcome|GCTcap - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTcap screening test
486062|NCT00787839|O3|Outcome|GCTpl - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTpl screening test
486063|NCT00787839|O2|Outcome|GCTcap - Diabetes - VA|VA costs per case of diabetes identified, using the GCTcap screening test
486064|NCT00787839|O1|Outcome|GCTpl - Diabetes - VA|VA costs per case of diabetes identified, using the GCTpl screening test
486065|NCT00787839|O10|Outcome|A1c - Dysglycemia|hemoglobin A1c, measured at the time of the OGTT
486066|NCT00787839|O9|Outcome|RCG - Dysglycemia|random capillary glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
486067|NCT00787839|O8|Outcome|RPG - Dysglycemia|random plasma glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
486068|NCT00787839|O7|Outcome|GCTcap - Dysglycemia|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
486069|NCT00787839|O6|Outcome|GCTpl - Dysglycemia|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
486070|NCT00787839|O5|Outcome|A1c - Diabetes|hemoglobin A1c, measured at the time of the OGTT
486071|NCT00787839|O4|Outcome|RCG - Diabetes|random capillary glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
486072|NCT00787839|O3|Outcome|RPG - Diabetes|random plasma glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
486073|NCT00787839|O2|Outcome|GCTcap - Diabetes|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
486074|NCT00787839|O1|Outcome|GCTpl - Diabetes|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
486075|NCT00787839|E1|Reported Event|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, the American Diabetes Association, and the National Institutes of Health
486076|NCT00787800|B3|Baseline|Total|Total of all reporting groups
486077|NCT00787800|B2|Baseline|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486078|NCT00787800|B1|Baseline|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486079|NCT00787800|P2|Participant Flow|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486080|NCT00787800|P1|Participant Flow|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486081|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486153|NCT00787566|B4|Baseline|Total|Total of all reporting groups
486082|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486083|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486084|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486085|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486086|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486087|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486088|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486089|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486090|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486091|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486092|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486093|NCT00787800|E2|Reported Event|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
486094|NCT00787800|E1|Reported Event|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
486095|NCT00787787|B1|Baseline|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
486096|NCT00787787|P1|Participant Flow|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
486097|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
486098|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
486099|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
486100|NCT00787787|E1|Reported Event|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
486101|NCT00787761|B1|Baseline|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486102|NCT00787761|P1|Participant Flow|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486103|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486104|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486105|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486106|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486107|NCT00787761|O1|Outcome|Severe Graft Versus Host Disease|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol and who had severe graft versus host disease as a post-transplant complication
486108|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486109|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486110|NCT00787761|O1|Outcome|Transplant Recipients|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol
486111|NCT00787761|E1|Reported Event|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
486112|NCT00787644|B3|Baseline|Total|Total of all reporting groups
486113|NCT00787644|B2|Baseline|2. Placebo|Placebo: Matching placebo (inert tablet)
486114|NCT00787644|B1|Baseline|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
486115|NCT00787644|P2|Participant Flow|2. Placebo|Placebo: Matching placebo (inert tablet)
486116|NCT00787644|P1|Participant Flow|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
486117|NCT00787644|O2|Outcome|2. Placebo|Placebo: Matching placebo (inert tablet)
486118|NCT00787644|O1|Outcome|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
486119|NCT00787644|E2|Reported Event|2. Placebo|Placebo: Matching placebo (inert tablet)
486120|NCT00787644|E1|Reported Event|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
486121|NCT00787618|B4|Baseline|Total|Total of all reporting groups
486122|NCT00787618|B3|Baseline|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
486123|NCT00787618|B2|Baseline|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
486124|NCT00787618|B1|Baseline|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
486125|NCT00787618|P3|Participant Flow|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
486126|NCT00787618|P2|Participant Flow|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
486127|NCT00787618|P1|Participant Flow|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
486128|NCT00787618|O3|Outcome|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
486129|NCT00787618|O2|Outcome|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
486130|NCT00787618|O1|Outcome|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
486131|NCT00787618|E3|Reported Event|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
486132|NCT00787618|E2|Reported Event|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
486133|NCT00787618|E1|Reported Event|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
486134|NCT00787605|B3|Baseline|Total|Total of all reporting groups
486135|NCT00787605|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486136|NCT00787605|B1|Baseline|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486137|NCT00787605|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486138|NCT00787605|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486139|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486140|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486141|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486142|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486143|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486144|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486145|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486146|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486147|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486148|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
486149|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
486150|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
495683|NCT00766415|E2|Reported Event|Placebo|Placebo, twice daily
486155|NCT00787566|B2|Baseline|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
486156|NCT00787566|B1|Baseline|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
486157|NCT00787566|P3|Participant Flow|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
486158|NCT00787566|P2|Participant Flow|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
486159|NCT00787566|P1|Participant Flow|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
486160|NCT00787566|O3|Outcome|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
486161|NCT00787566|O2|Outcome|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
486162|NCT00787566|O1|Outcome|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
486163|NCT00787566|E3|Reported Event|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
486164|NCT00787566|E2|Reported Event|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
486165|NCT00787566|E1|Reported Event|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
486166|NCT00787527|B1|Baseline|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat) : Starting oral dose (Schedule A) of 300 mg once a day on Days 5-14 of 21 day cycle.~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
486167|NCT00787527|P1|Participant Flow|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin: 50 mg/m^2 by vein/intravenous (IV) over 15 minutes on Day 1 of 21 day cycle~Prednisone: 100 mg tablets by mouth/orally (PO) once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat): Phase I Starting dose of 300 mg by mouth each evening on Days 5-14 of 21 day cycle.~Cyclophosphamide: 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
486168|NCT00787527|O1|Outcome|Schedule B - Vorinostat Three Times Daily|"Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle.~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
486169|NCT00787527|O2|Outcome|Schedule A - Vorinostat Twice Daily|"Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
486170|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
486171|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once or Twice Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle or Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
486172|NCT00787527|E2|Reported Event|Schedule B: Vorinostat Three Times Daily|"Phase II: Vorinostat administered at starting dose 300 mg orally three times daily from Days -2 to 3 (4500 mg over 5 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
486173|NCT00787527|E1|Reported Event|Schedule A: Vorinostat Once or Twice Daily|"Phase I: Vorinostat administered Days 5 to 14 at starting dose 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), next administered dose 200 mg orally twice daily (4000 mg over 10 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
486174|NCT00787332|B3|Baseline|Total|Total of all reporting groups
486175|NCT00787332|B2|Baseline|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
486176|NCT00787332|B1|Baseline|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
486177|NCT00787332|P2|Participant Flow|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
486178|NCT00787332|P1|Participant Flow|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
486179|NCT00787332|O2|Outcome|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
486180|NCT00787332|O1|Outcome|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
486181|NCT00787332|E2|Reported Event|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
486182|NCT00787332|E1|Reported Event|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
486218|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486183|NCT00787319|B1|Baseline|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486184|NCT00787319|P1|Participant Flow|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486185|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486186|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486187|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486188|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486189|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486190|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486191|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486192|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486193|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486194|NCT00787319|E1|Reported Event|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
486195|NCT00787267|B1|Baseline|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486196|NCT00787267|P1|Participant Flow|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486197|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486198|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486199|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486200|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486201|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486202|NCT00787267|E1|Reported Event|Evalulable Patients That Received Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
486203|NCT00787254|B3|Baseline|Total|Total of all reporting groups
486204|NCT00787254|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486205|NCT00787254|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486206|NCT00787254|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486207|NCT00787254|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486208|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486209|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486210|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486211|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486212|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486213|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486214|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486215|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486216|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486217|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486338|NCT00787202|O2|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486219|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486220|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486221|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486222|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486223|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486224|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486225|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486226|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486227|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486228|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486229|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486230|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486231|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486232|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486233|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486234|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486235|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486236|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486237|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486238|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486239|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486240|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486241|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486242|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486243|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486244|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486245|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486246|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486247|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486248|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486249|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486250|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486251|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486252|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486253|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486254|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486255|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486256|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486257|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486258|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486259|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486260|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486261|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486262|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486263|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486264|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486265|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486266|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486267|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486268|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486269|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486270|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486271|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486272|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486273|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486274|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486275|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486276|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486277|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486278|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486279|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486280|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486281|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486282|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486283|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486284|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486285|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486286|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486287|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486288|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486289|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486290|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486291|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486292|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486293|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486294|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486295|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486296|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486297|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486298|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486299|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486300|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486301|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486302|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486303|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486304|NCT00787254|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
486305|NCT00787254|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
486306|NCT00787241|B4|Baseline|Total|Total of all reporting groups
486307|NCT00787241|B3|Baseline|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
486308|NCT00787241|B2|Baseline|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
486309|NCT00787241|B1|Baseline|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
486310|NCT00787241|P3|Participant Flow|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
486311|NCT00787241|P2|Participant Flow|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
486312|NCT00787241|P1|Participant Flow|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
486313|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
486314|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
486315|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
486316|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
486317|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
486318|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
486319|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
486320|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
486321|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
486322|NCT00787241|E3|Reported Event|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
486323|NCT00787241|E2|Reported Event|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
486324|NCT00787241|E1|Reported Event|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
486325|NCT00787202|B6|Baseline|Total|Total of all reporting groups
486326|NCT00787202|B5|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486327|NCT00787202|B4|Baseline|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486328|NCT00787202|B3|Baseline|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486329|NCT00787202|B2|Baseline|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486330|NCT00787202|B1|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486331|NCT00787202|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486332|NCT00787202|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486333|NCT00787202|P3|Participant Flow|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486334|NCT00787202|P2|Participant Flow|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 milligram (mg) orally twice daily for 8 weeks.
486335|NCT00787202|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486336|NCT00787202|O4|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486337|NCT00787202|O3|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
487791|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
486339|NCT00787202|O1|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486340|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486341|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486342|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486343|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486344|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486345|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486346|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486347|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486348|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486349|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486350|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486351|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486352|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486353|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486354|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486355|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486356|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486357|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486358|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486359|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486360|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486361|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486362|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486363|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486364|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486365|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486366|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486367|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486368|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486369|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486370|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486371|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486372|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486373|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486374|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486375|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486376|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486377|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486378|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486379|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486380|NCT00787202|E5|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
486381|NCT00787202|E4|Reported Event|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
486382|NCT00787202|E3|Reported Event|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
486383|NCT00787202|E2|Reported Event|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
486384|NCT00787202|E1|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
486385|NCT00787189|B3|Baseline|Total|Total of all reporting groups
486386|NCT00787189|B2|Baseline|Control|Placebo laser device
486387|NCT00787189|B1|Baseline|Active|Active laser device
486388|NCT00787189|P2|Participant Flow|Control|Placebo laser device
486389|NCT00787189|P1|Participant Flow|Active|Active laser device
486390|NCT00787189|O2|Outcome|Control|Placebo laser device
486391|NCT00787189|O1|Outcome|Active|Active laser device
486392|NCT00787189|E2|Reported Event|Control|Placebo laser device
486393|NCT00787189|E1|Reported Event|Active|Active laser device
486394|NCT00787150|B4|Baseline|Total|Total of all reporting groups
486395|NCT00787150|B3|Baseline|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486396|NCT00787150|B2|Baseline|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486397|NCT00787150|B1|Baseline|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486398|NCT00787150|P3|Participant Flow|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486399|NCT00787150|P2|Participant Flow|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486400|NCT00787150|P1|Participant Flow|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486401|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486402|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486403|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486404|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486405|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486406|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486407|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486408|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486409|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486410|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486411|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486412|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486413|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486414|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486415|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486416|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486417|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486418|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486419|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486420|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486421|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486422|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486423|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486424|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486425|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486426|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486427|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486428|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486429|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486430|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486431|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486432|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486433|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486434|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486435|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486436|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486437|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486438|NCT00787150|E3|Reported Event|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486439|NCT00787150|E2|Reported Event|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
486440|NCT00787150|E1|Reported Event|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
486441|NCT00787137|B4|Baseline|Total|Total of all reporting groups
486442|NCT00787137|B3|Baseline|Placebo|Control, phosphate-buffered saline
486443|NCT00787137|B2|Baseline|PG102 1 mg/kg|Second dose PG102
486444|NCT00787137|B1|Baseline|PG102 0.3 mg/kg|Lowest dose PG102
486445|NCT00787137|P3|Participant Flow|Placebo|Control, phosphate-buffered saline
486446|NCT00787137|P2|Participant Flow|PG102 1 mg/kg|Second dose PG102
486447|NCT00787137|P1|Participant Flow|PG102 0.3 mg/kg|Lowest dose PG102
486448|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
486449|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
486450|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
486451|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
486452|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
486453|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
486454|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
486455|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
486456|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
486457|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
486458|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
486459|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
486460|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
486461|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
486462|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
486463|NCT00787137|E3|Reported Event|Placebo|Control, phosphate-buffered saline
486464|NCT00787137|E2|Reported Event|PG102 1 mg/kg|Second dose PG102
486465|NCT00787137|E1|Reported Event|PG102 0.3 mg/kg|Lowest dose PG102
486466|NCT00787124|B3|Baseline|Total|Total of all reporting groups
486467|NCT00787124|B2|Baseline|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
486468|NCT00787124|B1|Baseline|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
486469|NCT00787124|P2|Participant Flow|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
486470|NCT00787124|P1|Participant Flow|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
486471|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
486472|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
486473|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
486474|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
486475|NCT00787124|E2|Reported Event|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
486476|NCT00787124|E1|Reported Event|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
486477|NCT00787020|B3|Baseline|Total|Total of all reporting groups
486478|NCT00787020|B2|Baseline|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
486479|NCT00787020|B1|Baseline|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
486480|NCT00787020|P2|Participant Flow|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
486481|NCT00787020|P1|Participant Flow|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
486482|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
486483|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
486484|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
486485|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
486486|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
486487|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
486488|NCT00787020|E2|Reported Event|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
486489|NCT00787020|E1|Reported Event|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
486490|NCT00786994|B5|Baseline|Total|Total of all reporting groups
486491|NCT00786994|B4|Baseline|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
486492|NCT00786994|B3|Baseline|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
486493|NCT00786994|B2|Baseline|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
486494|NCT00786994|B1|Baseline|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
486495|NCT00786994|P4|Participant Flow|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
486496|NCT00786994|P3|Participant Flow|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
486497|NCT00786994|P2|Participant Flow|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
486498|NCT00786994|P1|Participant Flow|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
486499|NCT00786994|O3|Outcome|C/D - Placebo Once or Twice Daily|"Placebo (petroleum jelly) for three months once or twice a day~Placebo (petroleum jelly)"
486500|NCT00786994|O2|Outcome|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
486501|NCT00786994|O1|Outcome|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
486502|NCT00786994|E4|Reported Event|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day~Placebo (petroleum jelly)"
486503|NCT00786994|E3|Reported Event|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day~Placebo (petroleum jelly)"
486504|NCT00786994|E2|Reported Event|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
486505|NCT00786994|E1|Reported Event|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
486506|NCT00786916|B4|Baseline|Total|Total of all reporting groups
486507|NCT00786916|B3|Baseline|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486508|NCT00786916|B2|Baseline|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486509|NCT00786916|B1|Baseline|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486553|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486554|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486510|NCT00786916|P3|Participant Flow|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486511|NCT00786916|P2|Participant Flow|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486512|NCT00786916|P1|Participant Flow|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486513|NCT00786916|O3|Outcome|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486514|NCT00786916|O2|Outcome|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486515|NCT00786916|O1|Outcome|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
486516|NCT00786916|E3|Reported Event|Group C|0.50 mg/kg Lidocaine Group
486517|NCT00786916|E2|Reported Event|Group B|0.25 mg/kg Lidocaine Group
486518|NCT00786916|E1|Reported Event|Group A|Placebo (Saline) Group
486519|NCT00786864|B3|Baseline|Total|Total of all reporting groups
486520|NCT00786864|B2|Baseline|Control Group|Control group - no intervention
486521|NCT00786864|B1|Baseline|Exercise Intervention Group|Experimental Group
486522|NCT00786864|P2|Participant Flow|Control Group|Control group - no intervention
486523|NCT00786864|P1|Participant Flow|Exercise Intervention Group|Experimental Group
486524|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
486525|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
486526|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
486527|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
486528|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
486529|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
486530|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
486531|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
486532|NCT00786864|E2|Reported Event|Control Group|Control group - no intervention
486533|NCT00786864|E1|Reported Event|Exercise Intervention Group|Experimental Group
486534|NCT00786838|B1|Baseline|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486535|NCT00786838|P1|Participant Flow|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486536|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
486537|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1.
486538|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486539|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486540|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486541|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486542|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486543|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486544|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486545|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486546|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486547|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486548|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486549|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486550|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486551|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
486552|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486555|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486556|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
486557|NCT00786838|O1|Outcome|Placebo|Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
486558|NCT00786838|E1|Reported Event|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
486559|NCT00786799|B3|Baseline|Total|Total of all reporting groups
486560|NCT00786799|B2|Baseline|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
486561|NCT00786799|B1|Baseline|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
486562|NCT00786799|P2|Participant Flow|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
486563|NCT00786799|P1|Participant Flow|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
486564|NCT00786799|O2|Outcome|Placebo Group: Change in TNFα|
486565|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in TNFα|
486566|NCT00786799|O2|Outcome|Placebo Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the placebo group (100% * ((One Year - Baseline)/Baseline).
486567|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the active Omega-3 group (100% * ((One Year - Baseline)/Baseline)
486568|NCT00786799|O3|Outcome|Comparison Between Omega-3 and Placebo Groups|Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
486569|NCT00786799|O2|Outcome|Placebo|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only
486570|NCT00786799|O1|Outcome|Active Omega-3|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only
486571|NCT00786799|E2|Reported Event|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
486572|NCT00786799|E1|Reported Event|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
486573|NCT00786682|B1|Baseline|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
486574|NCT00786682|P1|Participant Flow|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
486575|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
486576|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
486577|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
486578|NCT00786682|E1|Reported Event|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
486579|NCT00786643|B3|Baseline|Total|Total of all reporting groups
486580|NCT00786643|B2|Baseline|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
486581|NCT00786643|B1|Baseline|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
486582|NCT00786643|P2|Participant Flow|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
486583|NCT00786643|P1|Participant Flow|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
486584|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
486585|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
486586|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
486587|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
486588|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
486589|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
486590|NCT00786643|E2|Reported Event|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
486591|NCT00786643|E1|Reported Event|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
486592|NCT00786565|B1|Baseline|Akreos Intraocular Lens|
486593|NCT00786565|P1|Participant Flow|Akreos Intraocular Lens|Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
486594|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486595|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486596|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486597|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486598|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486599|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486600|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486601|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486602|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486603|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486604|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486605|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486606|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486607|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486608|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486609|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486610|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486611|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486612|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486613|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486614|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486615|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486616|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486617|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486618|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486619|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486620|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486621|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486622|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486623|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486624|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486625|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486626|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
486627|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
486628|NCT00786565|E2|Reported Event|Akreos Adapt Intraocular Lens|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
486629|NCT00786565|E1|Reported Event|Akreos Advanced Intraocular Lenses|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
486630|NCT00786487|B5|Baseline|Total|Total of all reporting groups
486631|NCT00786487|B4|Baseline|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486632|NCT00786487|B3|Baseline|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486633|NCT00786487|B2|Baseline|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486634|NCT00786487|B1|Baseline|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486635|NCT00786487|P4|Participant Flow|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486636|NCT00786487|P3|Participant Flow|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486637|NCT00786487|P2|Participant Flow|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486638|NCT00786487|P1|Participant Flow|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486639|NCT00786487|O4|Outcome|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486640|NCT00786487|O3|Outcome|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486641|NCT00786487|O2|Outcome|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486642|NCT00786487|O1|Outcome|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486643|NCT00786487|E4|Reported Event|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486644|NCT00786487|E3|Reported Event|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486645|NCT00786487|E2|Reported Event|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
486646|NCT00786487|E1|Reported Event|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
486647|NCT00786474|B3|Baseline|Total|Total of all reporting groups
486648|NCT00786474|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
486649|NCT00786474|B1|Baseline|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
486650|NCT00786474|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
486651|NCT00786474|P1|Participant Flow|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
486652|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
486653|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
486654|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
486655|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
486656|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
486657|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
486658|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
486659|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
486660|NCT00786474|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
486661|NCT00786474|E1|Reported Event|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
486662|NCT00786422|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486663|NCT00786422|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486664|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486665|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486666|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486667|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486668|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486669|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
486670|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
486671|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
486672|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
486673|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
486674|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
486675|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486676|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486677|NCT00786422|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
486678|NCT00786409|B1|Baseline|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486679|NCT00786409|P1|Participant Flow|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486680|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486681|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486682|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486683|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486684|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486685|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486686|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486687|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486688|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486689|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486690|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486691|NCT00786409|O1|Outcome|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486692|NCT00786409|E1|Reported Event|Gardasil Vaccine|0.5 ml Gardasil vaccine at months 0, 2, and 6
486694|NCT00786188|B2|Baseline|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
486695|NCT00786188|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
486696|NCT00786188|P2|Participant Flow|Placebo - Sugar Pill|"Interventions Administered:~Subjects received placebo capsules administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive placebo administered once daily at bedtime."
486697|NCT00786188|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Interventions Administered:~Subjects received Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime."
486698|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486699|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486700|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486701|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486702|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486703|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486704|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486705|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486706|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486707|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486708|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486709|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486710|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486711|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486712|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486713|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486714|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486715|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
486716|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486717|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486718|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
486719|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg capsules.~Subjects will be randomized to one of the two treatments in a 1:1 ratio"
486720|NCT00786188|E2|Reported Event|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
486721|NCT00786188|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
486722|NCT00786032|B1|Baseline|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486723|NCT00786032|P1|Participant Flow|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486786|NCT00785577|B5|Baseline|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486724|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486725|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486726|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486727|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486728|NCT00786032|O1|Outcome|BCI Device - Time Assisting Patient With Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles. The time was measured of how long the the caregiver assisted the patient with the device."
486729|NCT00786032|O1|Outcome|BCI Device|"The McGill Quality of Life (MQOL) is a 16 item scale that has five distinct sub-measures: physical well-being; physical symptoms; psychological symptoms; existential well-being; support. These sub-measures are averaged to give a MQOL total score.~The range of total score is from 0 (worst) to 10 (best)."
486730|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486731|NCT00786032|E1|Reported Event|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
486732|NCT00785980|B1|Baseline|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
486733|NCT00785980|P1|Participant Flow|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
486734|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
486735|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
486736|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
486737|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
486738|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
486739|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
486740|NCT00785980|E3|Reported Event|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, all subjects received a dose of quinine sulfate (2 x 324 mg capsules) co-administered with a dose of ciprofloxacin (1 x 500 mg tablet) after an overnight fast of at least 10 hours.
486741|NCT00785980|E2|Reported Event|Ciprofloxacin Alone|Beginning on Day 8 in the morning and continuing through Day 11 in the evening, all subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice daily for a total of 8 doses.
486742|NCT00785980|E1|Reported Event|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period. On Day 11 in the morning, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) following an overnight fast of 10 hours.
486743|NCT00785798|B1|Baseline|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
486744|NCT00785798|P1|Participant Flow|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
486745|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
486746|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
486747|NCT00785798|E1|Reported Event|Vorinostat Doxil|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Vorinostat: 200mg to 400 mg twice daily on days 1-7~Pegylated Liposomal Doxorubicin (PLD), Doxil: IV 30mg/m2 on day 3 of a 21-day cycle"
486748|NCT00785785|B3|Baseline|Total|Total of all reporting groups
486749|NCT00785785|B2|Baseline|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
486750|NCT00785785|B1|Baseline|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
486751|NCT00785785|P2|Participant Flow|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
486752|NCT00785785|P1|Participant Flow|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
486753|NCT00785785|O2|Outcome|Imatinib|imatinib 400 mg once daily
486754|NCT00785785|O1|Outcome|Nilotinib|nilotinib 400 mg twice a day
486755|NCT00785785|E4|Reported Event|Crossover Imatinib|exposure to nilotinib and then imatinib
486756|NCT00785785|E3|Reported Event|Crossover Nilotinib|exposure to imatinib and then nilotinib
486757|NCT00785785|E2|Reported Event|Imatinib|Exposure to Imatinib only
486758|NCT00785785|E1|Reported Event|Nilotinib|Exposure to Nilotinib only
486759|NCT00785772|B1|Baseline|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
486760|NCT00785772|P1|Participant Flow|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
486761|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
486762|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
486763|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
486764|NCT00785772|E1|Reported Event|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
486765|NCT00785707|B1|Baseline|Cochlear Implant|children less than 24 months at time of cochlear implantation
486766|NCT00785707|P1|Participant Flow|Cochlear Implant|children less than 24 months at time of cochlear implantation
486767|NCT00785707|O1|Outcome|Cochlear Implant|children less than 24 months at time of cochlear implantation
486768|NCT00785707|O1|Outcome|Cochlear Implant|children less than 24 months at time of cochlear implantation
486769|NCT00785707|E1|Reported Event|Cochlear Implant|children less than 24 months at time of cochlear implantation
486770|NCT00785629|B5|Baseline|Total|Total of all reporting groups
486771|NCT00785629|B4|Baseline|Placebo|
486772|NCT00785629|B3|Baseline|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
486773|NCT00785629|B2|Baseline|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
486774|NCT00785629|B1|Baseline|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
486775|NCT00785629|P4|Participant Flow|Placebo|
486776|NCT00785629|P3|Participant Flow|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
486777|NCT00785629|P2|Participant Flow|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
486778|NCT00785629|P1|Participant Flow|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
486779|NCT00785629|O2|Outcome|All Placebo Treated Patients|All placebo treated patients
486780|NCT00785629|O1|Outcome|All Active Treated Patients|All actively treated patients
486781|NCT00785629|E4|Reported Event|Calcium Acetate|
486782|NCT00785629|E3|Reported Event|Sevelamer Carbonate|
486783|NCT00785629|E2|Reported Event|Lanthanum Carbonate|
486784|NCT00785629|E1|Reported Event|Placebo|
486785|NCT00785577|B6|Baseline|Total|Total of all reporting groups
487792|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
486787|NCT00785577|B4|Baseline|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486788|NCT00785577|B3|Baseline|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486789|NCT00785577|B2|Baseline|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486790|NCT00785577|B1|Baseline|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486791|NCT00785577|P5|Participant Flow|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486792|NCT00785577|P4|Participant Flow|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486793|NCT00785577|P3|Participant Flow|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486794|NCT00785577|P2|Participant Flow|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486795|NCT00785577|P1|Participant Flow|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486796|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486797|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486798|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486799|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486800|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486801|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486802|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486803|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486804|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486805|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486806|NCT00785577|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
486807|NCT00785577|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
486808|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486809|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486810|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486811|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486812|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486813|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486814|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486815|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486816|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486817|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486818|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486819|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486820|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486821|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486822|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486823|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486824|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486825|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
486826|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486827|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486828|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486829|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486830|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486831|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486832|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486833|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486834|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486835|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486836|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486837|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486838|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486839|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486840|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486841|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486842|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486843|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486844|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486845|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486846|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486847|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486848|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486849|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486850|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486851|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486852|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486853|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486854|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486855|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486856|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486857|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486858|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486859|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486860|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486861|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486862|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486863|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486864|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486865|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486866|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486867|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486868|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486869|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486870|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486871|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486872|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486873|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486874|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486875|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486876|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486877|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486878|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486879|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486880|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486881|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486882|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486883|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486884|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486885|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486886|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486887|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486888|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486889|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486890|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486891|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486892|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486893|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486894|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486895|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486896|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486897|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486898|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486899|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486900|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486901|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486902|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486903|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486904|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
486905|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
487061|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
486906|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486907|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486908|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486909|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486910|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486911|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486912|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486913|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
486914|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
486915|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486916|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486917|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486918|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
486919|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
486920|NCT00785577|E10|Reported Event|Pregabalin Washout|A one-week washout period in which no pregabalin was taken.
486921|NCT00785577|E9|Reported Event|LY545694 105 mg Washout|A one-week washout period in which no LY545694 105 mg was taken.
486922|NCT00785577|E8|Reported Event|LY545694 49 mg Washout|A one-week washout period in which no LY545694 49 mg was taken.
486923|NCT00785577|E7|Reported Event|LY545694 21 mg Washout|A one-week washout period in which no LY545694 21 mg was taken.
486924|NCT00785577|E6|Reported Event|Placebo Washout|A one-week washout period in which no placebo was taken.
486925|NCT00785577|E5|Reported Event|Pregabalin|Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
486926|NCT00785577|E4|Reported Event|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
486927|NCT00785577|E3|Reported Event|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
486928|NCT00785577|E2|Reported Event|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week
486929|NCT00785577|E1|Reported Event|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
486930|NCT00785512|B3|Baseline|Total|Total of all reporting groups
486931|NCT00785512|B2|Baseline|Placebo|Matching placebo tablets, oral administration
486932|NCT00785512|B1|Baseline|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
486933|NCT00785512|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
486934|NCT00785512|P1|Participant Flow|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
486935|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
486936|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
486937|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
486938|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
486939|NCT00785512|E3|Reported Event|Placebo|Matching placebo tablets, oral administration
486940|NCT00785512|E2|Reported Event|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
486941|NCT00785512|E1|Reported Event|Single-blind Nebivolol|Pre-randomization 12 week nebivolol treatment.
486942|NCT00785486|B1|Baseline|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
486943|NCT00785486|P1|Participant Flow|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
486944|NCT00785486|O2|Outcome|Qualaquin (Quinine) With Midazolam|On day 10 after six days of receiving Qualaquin 324 mg every 8 hours, and after a fast of at least 10 hours, patients received a 2 mg dose of midazolam and 324 mg of Qualaquin (quinine)(Steady state). Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(quinine) in the presence of midazolam over the final dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
486945|NCT00785486|O1|Outcome|Qualaquin (Quinine) Alone|On the morning of day 9 after taking an oral dose of Qualaquin quinine)324 mg every 8 hours for the prior 5 days (Steady state) and following a fast of at least 10 hours all participants took a an additional 324 mg oral dose of the drug. Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(Quinine) alone over the following dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
486946|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin(quinine) 324 mg. Blood was drawn sufficient to characterize AUC inf for 1- hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
486947|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg . Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
486948|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for 1-hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
486949|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
486950|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for 1-hydroxy midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
486951|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
486952|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of 1-hydroxy midazolam as calculated by the linear trapezoidal method.
486953|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of midazolam and 1-hydroxymidazolam
486954|NCT00785486|O6|Outcome|Quinine - Qualaquin (Quinine) With Midazolam|On the morning of day 10 after taking Qualaquin (quinine)capsules 324 mg orally every 8 hours for the prior 6 days, and following a fast of at least 10 hours all study participants co-ingested oral dose s of midazolam 2 mg and their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine)in the presence of midazolam.
486955|NCT00785486|O5|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg concurrently. On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the Cmax for 1-hydroxy-midazolam in the presence of Qualaquin (quinine) at steady state.
486956|NCT00785486|O4|Outcome|Midazolam - Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917. 12, 15 and 24 hours to determine Cmax for midazolam in the presence of Qualaquin (qunine)at steady state.
486957|NCT00785486|O3|Outcome|Quinine - Qualaquin(Quinine) Alone|On the morning of day 9 after taking Qualaquin(quinine)capsules 324 mg orally every 8 hours for the prior 5 days, and following a fast of at least 10 hours all study participants received their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine) at this dose.
486958|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for 1-hydroxy-midazolam, the primary metabolite of midazolam
486959|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for midazolam.
486960|NCT00785486|E3|Reported Event|Midazolam With Qualaquin (Quinine) Together|Adverse effects reported on day 10 after participants received 2 mg of midazolam syrup and 324 mg of Qualaquin(quinine)orally.
486961|NCT00785486|E2|Reported Event|Qualaquin (Quinine) Alone|Adverse effects(ADR)while taking Qualaquin(quinine)324 mg alone orally every 8 hours on days 4-11. Results are reported as total for the 7 day period.
486962|NCT00785486|E1|Reported Event|Midazolam Alone|Adverse effects on day 1 after participants received 2mg of midazolam syrup orally.
486963|NCT00785356|B4|Baseline|Total|Total of all reporting groups
486964|NCT00785356|B3|Baseline|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
486965|NCT00785356|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
486966|NCT00785356|B1|Baseline|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
486967|NCT00785356|P1|Participant Flow|All Groups|Proellex 25 mg, Proellex 50 mg, 1placebo
486968|NCT00785356|O3|Outcome|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
486969|NCT00785356|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
486970|NCT00785356|O1|Outcome|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
486971|NCT00785356|E3|Reported Event|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
486972|NCT00785356|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
486973|NCT00785356|E1|Reported Event|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
486974|NCT00785291|B4|Baseline|Total|Total of all reporting groups
486975|NCT00785291|B3|Baseline|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486976|NCT00785291|B2|Baseline|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486977|NCT00785291|B1|Baseline|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486978|NCT00785291|P3|Participant Flow|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486979|NCT00785291|P2|Participant Flow|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486980|NCT00785291|P1|Participant Flow|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486981|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486982|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486983|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486984|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486985|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486986|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486987|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486988|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486989|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486990|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486991|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486992|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486993|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486994|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486995|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486996|NCT00785291|E3|Reported Event|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
486997|NCT00785291|E2|Reported Event|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486998|NCT00785291|E1|Reported Event|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
486999|NCT00785213|B1|Baseline|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
487000|NCT00785213|P1|Participant Flow|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
487001|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
487002|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
487003|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
487004|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
487005|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
487006|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
487007|NCT00785213|E3|Reported Event|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects were co-administered a dose of rosiglitazone 4mg and quinine sulfate 648 mg (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
487008|NCT00785213|E2|Reported Event|Quinine Sulfate Alone|On Days 4-7, subjects received a dose of quinine sulfate 648 mg (2 x 324 mg capsules) every 8 hours beginning with the 7:15 a.m. dose on Day 4 and continuing through the 11:15 p.m. dose on Day 7.
487009|NCT00785213|E1|Reported Event|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period.
487010|NCT00785044|B1|Baseline|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
487011|NCT00785044|P1|Participant Flow|AdreView™- Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of adverse cardiac events (ACEs).
487012|NCT00785044|O2|Outcome|AdreView™- HF Group (With Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
487013|NCT00785044|O1|Outcome|AdreView™ - HF Group (With No Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with no ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
487014|NCT00785044|E1|Reported Event|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
487015|NCT00784979|B1|Baseline|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA >/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
487016|NCT00784979|P1|Participant Flow|CMVIG Followed by PP|MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
487017|NCT00784979|O1|Outcome|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
487018|NCT00784979|E1|Reported Event|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
487019|NCT00784927|B1|Baseline|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1.~20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
487020|NCT00784927|P1|Participant Flow|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
487021|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
487022|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
487023|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
487024|NCT00784927|O1|Outcome|Treatment|"Participants with lymphoplasmacytic lymphoma (Waldenstrom’s macroglobulinemia) will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles and analyzed as a separate cohort:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.~rituximab~cyclophosphamide~dexamethasone~lenalidomide"
487025|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
487026|NCT00784927|E1|Reported Event|Treatment|40 mg Dexamethasone orally on days 1, 8, 15, 22.
487027|NCT00784875|B5|Baseline|Total|Total of all reporting groups
487028|NCT00784875|B4|Baseline|Placebo|Participants received placebo in Period B (2-week treatment period).
487029|NCT00784875|B3|Baseline|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487030|NCT00784875|B2|Baseline|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487031|NCT00784875|B1|Baseline|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487032|NCT00784875|P4|Participant Flow|Placebo|Participants received placebo in a 2-week treatment period.
487033|NCT00784875|P3|Participant Flow|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487034|NCT00784875|P2|Participant Flow|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487035|NCT00784875|P1|Participant Flow|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487036|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487037|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487038|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487039|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487040|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487041|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487042|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487043|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period
487044|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487045|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487046|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487047|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487048|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487049|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487050|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487051|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487052|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487053|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487054|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487055|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487056|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487057|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487058|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487059|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487060|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487062|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487063|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487064|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487065|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487066|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487067|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487068|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487069|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487070|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487071|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487072|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487073|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487074|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487075|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487076|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
487077|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
487078|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
487079|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
487080|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487081|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487082|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487083|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487084|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487085|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487086|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487087|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487088|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487089|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487090|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487091|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487092|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487093|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487094|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487095|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487096|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487097|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487098|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487099|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487100|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487101|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487102|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487103|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487104|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487105|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487106|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487107|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487108|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487109|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487110|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487111|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487112|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487113|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487114|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487115|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487116|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487117|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
495684|NCT00766415|E1|Reported Event|AZD1981|AZD1981 1000 mg, twice daily
487118|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487119|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487120|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487121|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487122|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487123|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487124|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487125|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487126|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487127|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487128|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487129|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487130|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487131|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487132|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
487133|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487134|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
487135|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
487136|NCT00784875|E12|Reported Event|Period D - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
487137|NCT00784875|E11|Reported Event|Period D - Placebo|Patients received placebo in Period D (2-week treatment period).
487138|NCT00784875|E10|Reported Event|Period D - LY2624803 3 mg|Patients received LY2624803 3 mg in Period D (2-week treatment period).
487139|NCT00784875|E9|Reported Event|Period D - LY2624803 1 mg|Patients received LY2624803 1 mg in Period D (2-week treatment period.
487140|NCT00784875|E8|Reported Event|Period C - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
487141|NCT00784875|E7|Reported Event|Period C - Placebo|Patients received placebo in Period C (2-week treatment period).
487142|NCT00784875|E6|Reported Event|Period C - LY2624803 3 mg|Patients received LY2624803 3 mg in Period C (2-week treatment period).
487143|NCT00784875|E5|Reported Event|Period C - LY2624803 1 mg|Patients received LY2624803 1 mg in Period C (2-week treatment period.
487144|NCT00784875|E4|Reported Event|Period B - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
487145|NCT00784875|E3|Reported Event|Period B - Placebo|Patients received placebo in Period B (2-week treatment period).
487146|NCT00784875|E2|Reported Event|Period B - LY2624803 3 mg|Patients received LY2624803 3 mg in Period B (2-week treatment period).
487147|NCT00784875|E1|Reported Event|Period B - LY2624803 1 mg|Patients received LY2624803 1 mg in Period B (2-week treatment period.
487148|NCT00784849|B1|Baseline|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
487149|NCT00784849|P1|Participant Flow|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
487150|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
487151|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
487152|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
487153|NCT00784849|E1|Reported Event|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
487154|NCT00784836|B1|Baseline|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
487155|NCT00784836|P1|Participant Flow|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
487156|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
487157|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
487158|NCT00784836|E1|Reported Event|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
487159|NCT00784810|B3|Baseline|Total|Total of all reporting groups
487160|NCT00784810|B2|Baseline|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
487161|NCT00784810|B1|Baseline|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
487162|NCT00784810|P2|Participant Flow|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
487163|NCT00784810|P1|Participant Flow|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
487164|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
487165|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
487166|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
487167|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
487168|NCT00784810|E2|Reported Event|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
487169|NCT00784810|E1|Reported Event|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
487170|NCT00784784|B3|Baseline|Total|Total of all reporting groups
495864|NCT00765817|B3|Baseline|Total|Total of all reporting groups
487171|NCT00784784|B2|Baseline|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
487172|NCT00784784|B1|Baseline|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
487173|NCT00784784|P2|Participant Flow|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
487174|NCT00784784|P1|Participant Flow|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
487175|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
487176|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
487177|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
487178|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
487179|NCT00784784|E2|Reported Event|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
487180|NCT00784784|E1|Reported Event|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
487181|NCT00784719|B8|Baseline|Total|Total of all reporting groups
487182|NCT00784719|B7|Baseline|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487183|NCT00784719|B6|Baseline|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487184|NCT00784719|B5|Baseline|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487185|NCT00784719|B4|Baseline|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487186|NCT00784719|B3|Baseline|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487187|NCT00784719|B2|Baseline|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487188|NCT00784719|B1|Baseline|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487189|NCT00784719|P7|Participant Flow|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487190|NCT00784719|P6|Participant Flow|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487191|NCT00784719|P5|Participant Flow|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487192|NCT00784719|P4|Participant Flow|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487193|NCT00784719|P3|Participant Flow|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487194|NCT00784719|P2|Participant Flow|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487195|NCT00784719|P1|Participant Flow|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487196|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487197|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487198|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487199|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487200|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487201|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487202|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487203|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487204|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487205|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487206|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487207|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487208|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487209|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487210|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487211|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487212|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487213|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487214|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487215|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487216|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487217|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487218|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487219|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487220|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487221|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487222|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487223|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487224|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487225|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487226|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487227|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487228|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487229|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487230|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487231|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487232|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487233|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487234|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487235|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487236|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487237|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487238|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487239|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487240|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487241|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487242|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487243|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487244|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487245|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487246|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487247|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487248|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487249|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487250|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487251|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487252|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487253|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487254|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487255|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487256|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487257|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487258|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487259|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487260|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487261|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487262|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487263|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487264|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487265|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487266|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487267|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487268|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487269|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487270|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487271|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487272|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487273|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487274|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487275|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487276|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487277|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487278|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487279|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487280|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487281|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487282|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487283|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487284|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487285|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487286|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487287|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487288|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487289|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487290|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487291|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487292|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487293|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487294|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487295|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487296|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487297|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487298|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487299|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487300|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487301|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487302|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487303|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487304|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487305|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487306|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487307|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487308|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487309|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487310|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487311|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487312|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487313|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487314|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487315|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487316|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487317|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487318|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487319|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487320|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487321|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487322|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487323|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487324|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487325|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487326|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487327|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487328|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487329|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487330|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487331|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487332|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487333|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487334|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487335|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487336|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487337|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487338|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487339|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487340|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487341|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487342|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487343|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487557|NCT00784147|B2|Baseline|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487344|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487345|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487346|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487347|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487348|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487349|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487350|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487351|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487352|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487353|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487354|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487355|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487356|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487357|NCT00784719|E7|Reported Event|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
487358|NCT00784719|E6|Reported Event|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
487359|NCT00784719|E5|Reported Event|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
487360|NCT00784719|E4|Reported Event|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
487361|NCT00784719|E3|Reported Event|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
487362|NCT00784719|E2|Reported Event|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
487363|NCT00784719|E1|Reported Event|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
487364|NCT00784654|B1|Baseline|All Enrolled Subjects|
487365|NCT00784654|P3|Participant Flow|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487366|NCT00784654|P2|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487367|NCT00784654|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
487368|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487369|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487370|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
487371|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487372|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487373|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487374|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487375|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
487376|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487377|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487378|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
487379|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487380|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487381|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
487382|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487383|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487384|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
487385|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
487386|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487387|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487388|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
487389|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
487390|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487391|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
487392|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
487393|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
487394|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
487395|NCT00784654|E3|Reported Event|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM for up to 6 weeks.
487396|NCT00784654|E2|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM for up to 6 weeks.
487397|NCT00784654|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM).
487398|NCT00784563|B4|Baseline|Total|Total of all reporting groups
487399|NCT00784563|B3|Baseline|Continuous-Year 3|Participants who were assigned to continuous training in the third year of the study without randomization. Due to potentially increased risk of knee pain without additional fitness benefits, we dropped the interval group for the third year.
487400|NCT00784563|B2|Baseline|Interval Training -Years 1 & 2|Participants who were randomized to interval training in the first 2 years of the study.
487401|NCT00784563|B1|Baseline|Continuous Training-Years 1 & 2|Participants who were randomized to continuous training in the first 2 years of the study.
487402|NCT00784563|P3|Participant Flow|Continuous Training - Year 3|Participant were assigned to continuous training without randomization.
487403|NCT00784563|P2|Participant Flow|Interval Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking.
487404|NCT00784563|P1|Participant Flow|Continuous Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. The goal for continuous training was to remain within 70-80% of HRmax throughout the session.
487405|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
487406|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
487407|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
487408|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
487409|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
487410|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
487411|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
487412|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
487413|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
487414|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
487415|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
487416|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
487417|NCT00784563|E2|Reported Event|Interval Training|This group consists of 22 subjects who were randomized to interval training in the first two years of the study. No subjects were assigned to the interval training in the third year of the study.
487418|NCT00784563|E1|Reported Event|Continuous Training|This group consists of 21 subjects who were randomized to continuous training in the first two years of the study and 17 subjects who were assigned to continuous training without randomization in the third year of the study. Thus, total group size is 38.
487419|NCT00784550|B3|Baseline|Total|Total of all reporting groups
487420|NCT00784550|B2|Baseline|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487421|NCT00784550|B1|Baseline|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487422|NCT00784550|P2|Participant Flow|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487423|NCT00784550|P1|Participant Flow|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487424|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487425|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487426|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487427|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487428|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487429|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487430|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487431|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487432|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487433|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487434|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487435|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487436|NCT00784550|E2|Reported Event|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
487437|NCT00784550|E1|Reported Event|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
487438|NCT00784459|B3|Baseline|Total|Total of all reporting groups
487439|NCT00784459|B2|Baseline|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
487440|NCT00784459|B1|Baseline|Placebo|Placebo : Treatment with Placebo, IV
487441|NCT00784459|P2|Participant Flow|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
487442|NCT00784459|P1|Participant Flow|Placebo|Placebo : Treatment with Placebo, IV
487443|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
487444|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
487445|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
487446|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
487447|NCT00784459|E2|Reported Event|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
487448|NCT00784459|E1|Reported Event|Placebo|Placebo : Treatment with Placebo, IV
487449|NCT00784368|B4|Baseline|Total|Total of all reporting groups
487450|NCT00784368|B3|Baseline|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487793|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487451|NCT00784368|B2|Baseline|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487452|NCT00784368|B1|Baseline|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487453|NCT00784368|P3|Participant Flow|FN (Switched Treatment)|Participants with febrile (with fever) neutropenia (a decrease in white blood cells) (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487454|NCT00784368|P2|Participant Flow|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487455|NCT00784368|P1|Participant Flow|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487456|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487457|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487458|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487459|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487460|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487461|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487462|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487463|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487464|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487483|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487558|NCT00784147|B1|Baseline|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487465|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487466|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487467|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487468|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487469|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487470|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487471|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487472|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487473|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487474|NCT00784368|O1|Outcome|SFI (JK1211 Monotherapy)|Participants with deep-seated mycosis (SFI) received JK1211 orally (taken by mouth; to be swallowed) in the dose range of 20 milliliter per day (ml/day) to 40 ml/day for 12 weeks as per Investigator’s discretion.
487475|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487476|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487477|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487478|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487479|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487480|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487481|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487482|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487484|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487485|NCT00784368|E3|Reported Event|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487486|NCT00784368|E2|Reported Event|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487487|NCT00784368|E1|Reported Event|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
487488|NCT00784277|B5|Baseline|Total|Total of all reporting groups
487489|NCT00784277|B4|Baseline|Oxycodone|IR Treatment : 10mg capsule for 14 days
487490|NCT00784277|B3|Baseline|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
487491|NCT00784277|B2|Baseline|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
487492|NCT00784277|B1|Baseline|Placebo|IR Treatment : 1 capsule for 14 days
487493|NCT00784277|P7|Participant Flow|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
487494|NCT00784277|P6|Participant Flow|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
487495|NCT00784277|P5|Participant Flow|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
487496|NCT00784277|P4|Participant Flow|Oxycodone|IR Treatment : 10mg for 14 days
487497|NCT00784277|P3|Participant Flow|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
487498|NCT00784277|P2|Participant Flow|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
487499|NCT00784277|P1|Participant Flow|Placebo|IR Treatment : 1 capsule for 14 days
487500|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
487501|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
487502|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
487503|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
487504|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
487505|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
487506|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
487507|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
487508|NCT00784277|E7|Reported Event|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
487509|NCT00784277|E6|Reported Event|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
487510|NCT00784277|E5|Reported Event|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
487511|NCT00784277|E4|Reported Event|Oxycodone|IR Treatment : 10mg for 14 days
487512|NCT00784277|E3|Reported Event|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
487513|NCT00784277|E2|Reported Event|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
487514|NCT00784277|E1|Reported Event|Placebo|IR Treatment : 1 capsule for 14 days
487515|NCT00784238|B1|Baseline|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
487516|NCT00784238|P1|Participant Flow|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
487517|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487518|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487519|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487520|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487521|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487554|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
487559|NCT00784147|P2|Participant Flow|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487522|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487523|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487524|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487525|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487526|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487527|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487528|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487529|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487530|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487531|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487532|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487533|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487534|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487535|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
487536|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487537|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487555|NCT00784238|E1|Reported Event|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
487556|NCT00784147|B3|Baseline|Total|Total of all reporting groups
487716|NCT00784030|B1|Baseline|Polycystic Kidney Disease (PKD) Patients|
487538|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487539|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487540|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487541|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487542|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487543|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487544|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487545|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487546|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487547|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487548|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487549|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487550|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487551|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
487552|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
487553|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
487717|NCT00784030|P2|Participant Flow|Healthy Patients|
487560|NCT00784147|P1|Participant Flow|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487561|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487562|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487563|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487564|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487565|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487566|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487567|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487568|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487569|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487570|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487571|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487572|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487573|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487574|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487575|NCT00784147|E2|Reported Event|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
487576|NCT00784147|E1|Reported Event|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
487577|NCT00784134|B3|Baseline|Total|Total of all reporting groups
487578|NCT00784134|B2|Baseline|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487579|NCT00784134|B1|Baseline|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487580|NCT00784134|P2|Participant Flow|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487581|NCT00784134|P1|Participant Flow|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487582|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487583|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487584|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487585|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487586|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487587|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487588|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487589|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487590|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487591|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487592|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487593|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487594|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487595|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487596|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487597|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487598|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487599|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487600|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487601|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487602|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487603|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487604|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487605|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487606|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487607|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487608|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487609|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487610|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487611|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487612|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487613|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487614|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487615|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487616|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487617|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487618|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487619|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487620|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487621|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487622|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487623|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487624|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487625|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487718|NCT00784030|P1|Participant Flow|Polycystic Kidney Disease (PKD) Patients|Patients who present with polycystic kidney disease (PKD)
487626|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487627|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487628|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487629|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487630|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487631|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487632|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487633|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487634|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487635|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487636|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487637|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487638|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487639|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487640|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487641|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487642|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487643|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487644|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487645|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487646|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487647|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487648|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487649|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487650|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487651|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487652|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487653|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487654|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487655|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487719|NCT00784030|O2|Outcome|Healthy Controls|Healthy Controls
487720|NCT00784030|O1|Outcome|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
487656|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487657|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487658|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487659|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487660|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487661|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487662|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487663|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487664|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487665|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487666|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487667|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487668|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487669|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487670|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487671|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487672|NCT00784134|O2|Outcome|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487673|NCT00784134|O1|Outcome|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487674|NCT00784134|E2|Reported Event|Saline Placebo|"1 ml of normal saline administered via the intraventricular catheter~Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487675|NCT00784134|E1|Reported Event|Alteplase|"Administration of alteplase via the intraventricular catheter~Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses"
487676|NCT00784095|B4|Baseline|Total|Total of all reporting groups
487677|NCT00784095|B3|Baseline|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
487678|NCT00784095|B2|Baseline|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
487679|NCT00784095|B1|Baseline|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487680|NCT00784095|P3|Participant Flow|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
487681|NCT00784095|P2|Participant Flow|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
487682|NCT00784095|P1|Participant Flow|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487683|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
487684|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
487721|NCT00784030|E2|Reported Event|Healthy Controls|Healthy Controls
487685|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487686|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
487687|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
487688|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487689|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
487690|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
487691|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487692|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
487693|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
487694|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487695|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
487696|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
487697|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487698|NCT00784095|E3|Reported Event|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
487699|NCT00784095|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects listened to a non-guided relaxation CD."
487700|NCT00784095|E1|Reported Event|Preparation and Completion|"Subjects in the first group (treatment) met with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
487701|NCT00784043|B3|Baseline|Total|Total of all reporting groups
487702|NCT00784043|B2|Baseline|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
487703|NCT00784043|B1|Baseline|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
487704|NCT00784043|P2|Participant Flow|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
487705|NCT00784043|P1|Participant Flow|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
487706|NCT00784043|O2|Outcome|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
487707|NCT00784043|O1|Outcome|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
487708|NCT00784043|O2|Outcome|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
487709|NCT00784043|O1|Outcome|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
487710|NCT00784043|O2|Outcome|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
487711|NCT00784043|O1|Outcome|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
487712|NCT00784043|E2|Reported Event|Unilateral|"Unilaterally implanted~Cochlear Implant: Bilateral Implantation in children"
487713|NCT00784043|E1|Reported Event|Bilateral|"Bilaterally implanted simultaneously~Cochlear Implant: Bilateral Implantation in children"
487714|NCT00784030|B3|Baseline|Total|Total of all reporting groups
487715|NCT00784030|B2|Baseline|Healthy Patients|
487722|NCT00784030|E1|Reported Event|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
487723|NCT00783965|B3|Baseline|Total|Total of all reporting groups
487724|NCT00783965|B2|Baseline|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487725|NCT00783965|B1|Baseline|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487726|NCT00783965|P2|Participant Flow|Arm II|Vehicle (placebo) first, then 0.1% tazarotene cream
487727|NCT00783965|P1|Participant Flow|Arm I|0.1% tazarotene cream first, then placebo
487728|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487729|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487730|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487731|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487732|NCT00783965|E2|Reported Event|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487733|NCT00783965|E1|Reported Event|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
487734|NCT00783952|B1|Baseline|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
487735|NCT00783952|P1|Participant Flow|Mixed Venous Oxygen and Calculation of Saturation|"Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
487736|NCT00783952|O2|Outcome|Patients With Cerebral/Somatic Tissue Oximeter Device|"Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
487737|NCT00783952|O1|Outcome|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
487738|NCT00783952|E1|Reported Event|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
487739|NCT00783835|B1|Baseline|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487740|NCT00783835|P1|Participant Flow|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487741|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487742|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487743|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487744|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487745|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487746|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487747|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487748|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487749|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487750|NCT00783835|E1|Reported Event|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
487751|NCT00783796|B1|Baseline|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487752|NCT00783796|P1|Participant Flow|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
487753|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487754|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487755|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487756|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487757|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487758|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487759|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487760|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487761|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487762|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487763|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487764|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487765|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487766|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487767|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487768|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487769|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487770|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487771|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487772|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487773|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487774|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487775|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487776|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487777|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487778|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487779|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487780|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487781|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487782|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487783|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487784|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487785|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487786|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487787|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487788|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487794|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487795|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487796|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487797|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487798|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487799|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487800|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487801|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487802|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487803|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487804|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487805|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487806|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487807|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487808|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487809|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487810|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487811|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487812|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487813|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487814|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487815|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487816|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487817|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487818|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487819|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487820|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487821|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487822|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487823|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487824|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487825|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487826|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487827|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487828|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487829|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487830|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487831|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487832|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487833|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487834|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487835|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487836|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487837|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487838|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487839|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487840|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487841|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487842|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487843|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487844|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487845|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487846|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487847|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487848|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
487849|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
487850|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
487851|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487852|NCT00783796|E1|Reported Event|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
487853|NCT00783718|B4|Baseline|Total|Total of all reporting groups
487987|NCT00783614|E1|Reported Event|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
487854|NCT00783718|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487855|NCT00783718|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487856|NCT00783718|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
487857|NCT00783718|P7|Participant Flow|Maintenance Phase: Non-responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
487858|NCT00783718|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487859|NCT00783718|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
487860|NCT00783718|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487861|NCT00783718|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487862|NCT00783718|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487863|NCT00783718|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
487864|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487865|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487866|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487867|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487868|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487869|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487870|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487871|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487872|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487873|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487874|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487875|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487876|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
487877|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
487878|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
487879|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
487880|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487988|NCT00783432|B3|Baseline|Total|Total of all reporting groups
487881|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487882|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487883|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
487884|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
487885|NCT00783718|E3|Reported Event|Vedolizumab|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
487886|NCT00783718|E2|Reported Event|Vedolizumab Then Placebo|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
487887|NCT00783718|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
487888|NCT00783705|B3|Baseline|Total|Total of all reporting groups
487889|NCT00783705|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487890|NCT00783705|B1|Baseline|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487891|NCT00783705|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487892|NCT00783705|P1|Participant Flow|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487893|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487894|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487895|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487896|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487897|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487898|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487899|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487900|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487901|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487902|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487903|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487904|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487905|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487906|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487907|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487908|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487909|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487910|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487911|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487912|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487913|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487914|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487915|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487989|NCT00783432|B2|Baseline|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
487916|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487917|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487918|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487919|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487920|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487921|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487922|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487923|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487924|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487925|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487926|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487927|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487928|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487929|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487930|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487931|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487932|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487933|NCT00783705|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487934|NCT00783705|E1|Reported Event|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
487935|NCT00783692|B4|Baseline|Total|Total of all reporting groups
487936|NCT00783692|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487937|NCT00783692|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487938|NCT00783692|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2.
487939|NCT00783692|P7|Participant Flow|Maintenance Phase: Non-Responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
487940|NCT00783692|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487941|NCT00783692|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
487942|NCT00783692|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487943|NCT00783692|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487944|NCT00783692|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
487945|NCT00783692|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
487946|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487947|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487990|NCT00783432|B1|Baseline|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
487991|NCT00783432|P2|Participant Flow|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
487948|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487949|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487950|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487951|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487952|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487953|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487954|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487955|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
487956|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
487957|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
487958|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
487959|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
487960|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
487961|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
487962|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
487963|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
487964|NCT00783692|E3|Reported Event|VDZ/VDZ|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
487965|NCT00783692|E2|Reported Event|VDZ/PBO|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
487966|NCT00783692|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
487967|NCT00783614|B5|Baseline|Total|Total of all reporting groups
487968|NCT00783614|B4|Baseline|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
487969|NCT00783614|B3|Baseline|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
487970|NCT00783614|B2|Baseline|ART and Placebo|Start ART immediately and initiate placebo pill daily
487971|NCT00783614|B1|Baseline|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
487972|NCT00783614|P4|Participant Flow|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
487973|NCT00783614|P3|Participant Flow|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
487974|NCT00783614|P2|Participant Flow|ART and Placebo|Start ART immediately and initiate placebo pill daily
487975|NCT00783614|P1|Participant Flow|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
487976|NCT00783614|O4|Outcome|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
487977|NCT00783614|O3|Outcome|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
487978|NCT00783614|O2|Outcome|ART and Placebo|Start ART immediately and initiate placebo pill daily
487979|NCT00783614|O1|Outcome|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
487980|NCT00783614|O4|Outcome|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
487981|NCT00783614|O3|Outcome|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
487982|NCT00783614|O2|Outcome|ART and Placebo|Start ART immediately and initiate placebo pill daily
487983|NCT00783614|O1|Outcome|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
487984|NCT00783614|E4|Reported Event|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
487985|NCT00783614|E3|Reported Event|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
487986|NCT00783614|E2|Reported Event|ART and Placebo|Start ART immediately and initiate placebo pill daily
487992|NCT00783432|P1|Participant Flow|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
487993|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
487994|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
487995|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
487996|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
487997|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
487998|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
487999|NCT00783432|E2|Reported Event|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
488000|NCT00783432|E1|Reported Event|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
488001|NCT00783302|B1|Baseline|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
488002|NCT00783302|P1|Participant Flow|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
488003|NCT00783302|O3|Outcome|Follow-up Period at 12 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 12 months.
488004|NCT00783302|O2|Outcome|Follow-up Period at 6 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 6 months.
488005|NCT00783302|O1|Outcome|Follow-up Period at 1 Month|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 1 month.
488006|NCT00783302|O3|Outcome|Negative Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
488007|NCT00783302|O2|Outcome|Negative Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
488008|NCT00783302|O1|Outcome|Negative Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
488009|NCT00783302|O3|Outcome|Specificity - Subject Follow-up Period 12 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
488010|NCT00783302|O2|Outcome|Specificity - Subject Follow-up Period 6 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
488011|NCT00783302|O1|Outcome|Specificity - Subject Follow-up Period 1 Month|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
488012|NCT00783302|O3|Outcome|Positive Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
488013|NCT00783302|O2|Outcome|Positive Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
488014|NCT00783302|O1|Outcome|Positive Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
488015|NCT00783302|O3|Outcome|Sensitivity - Subject Follow-up Period 12 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
488016|NCT00783302|O2|Outcome|Sensitivity - Subject Follow-up Period 6 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
488017|NCT00783302|O1|Outcome|Sensitivity - Subject Follow-up Period 1 Month|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
488018|NCT00783302|E1|Reported Event|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
488019|NCT00783263|B5|Baseline|Total|Total of all reporting groups
488020|NCT00783263|B4|Baseline|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
488021|NCT00783263|B3|Baseline|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
488022|NCT00783263|B2|Baseline|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
488023|NCT00783263|B1|Baseline|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
488024|NCT00783263|P4|Participant Flow|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
488025|NCT00783263|P3|Participant Flow|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
488026|NCT00783263|P2|Participant Flow|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
488027|NCT00783263|P1|Participant Flow|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
488028|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
488029|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
488030|NCT00783263|O4|Outcome|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
488031|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
488032|NCT00783263|O2|Outcome|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
488033|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
488034|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
488035|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
488036|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
488037|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
488038|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
488039|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
488040|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received rosuvastatin (5 or 10 mg) mg tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
488041|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
488042|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
488043|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
488044|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
488045|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
488046|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
488047|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus (5 or 10 mg) rosuvastatin for an additional 6 weeks.
488048|NCT00783263|E4|Reported Event|Rosuva 20 mg|Participants who received rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
488049|NCT00783263|E3|Reported Event|Rosuva 10 mg + EZ 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
488050|NCT00783263|E2|Reported Event|Rosuva 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
488051|NCT00783263|E1|Reported Event|Rosuva 5 mg + EZ 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5mg rosuvastatin for an additional 6 weeks.
488052|NCT00783224|B5|Baseline|Total|Total of all reporting groups
488053|NCT00783224|B4|Baseline|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
488054|NCT00783224|B3|Baseline|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
488055|NCT00783224|B2|Baseline|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
488056|NCT00783224|B1|Baseline|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
488057|NCT00783224|P4|Participant Flow|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
488058|NCT00783224|P3|Participant Flow|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
488059|NCT00783224|P2|Participant Flow|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
488060|NCT00783224|P1|Participant Flow|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
488061|NCT00783224|O4|Outcome|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
488062|NCT00783224|O3|Outcome|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
488063|NCT00783224|O2|Outcome|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
496540|NCT00764517|B3|Baseline|Total|Total of all reporting groups
488064|NCT00783224|O1|Outcome|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
488065|NCT00783224|E3|Reported Event|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
488066|NCT00783224|E2|Reported Event|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
488067|NCT00783224|E1|Reported Event|Mometasone Furoate Placebo and Fluticasone Propionate Placebo|Both placebo groups (arms) were combined to report adverse events
488068|NCT00783198|B4|Baseline|Total|Total of all reporting groups
488069|NCT00783198|B3|Baseline|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488070|NCT00783198|B2|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488071|NCT00783198|B1|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488072|NCT00783198|P3|Participant Flow|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488073|NCT00783198|P2|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488074|NCT00783198|P1|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488075|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488076|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488077|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488078|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488079|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488080|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488081|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488082|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488083|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488084|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488085|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488086|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488087|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488088|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488089|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488090|NCT00783198|E3|Reported Event|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488091|NCT00783198|E2|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488092|NCT00783198|E1|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
488093|NCT00783094|B4|Baseline|Total|Total of all reporting groups
488094|NCT00783094|B3|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488095|NCT00783094|B2|Baseline|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488096|NCT00783094|B1|Baseline|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488097|NCT00783094|P3|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488175|NCT00782834|P1|Participant Flow|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
488098|NCT00783094|P2|Participant Flow|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488099|NCT00783094|P1|Participant Flow|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488100|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488101|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488102|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488103|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488104|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488105|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488106|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488107|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488108|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488109|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488110|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488111|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488112|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488113|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488114|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488115|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488116|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488117|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488118|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488119|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488120|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488121|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488122|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488123|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488124|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488125|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488126|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488127|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488128|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488129|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488130|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488131|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488132|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488133|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488134|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488135|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488136|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488137|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488138|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488139|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488140|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488141|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488142|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488143|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488144|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488145|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488146|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488147|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488148|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488149|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488150|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488151|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488152|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488153|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488154|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488155|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488156|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488157|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488158|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488159|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488160|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488161|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488162|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488163|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488164|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488165|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
488166|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488167|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
488168|NCT00783094|E6|Reported Event|Placebo: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
488169|NCT00783094|E5|Reported Event|Tadalafil 5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
488170|NCT00783094|E4|Reported Event|Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
488171|NCT00783094|E3|Reported Event|Placebo - Double-Blind Phase|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase."
488172|NCT00783094|E2|Reported Event|Tadalafil 5 mg - Double-Blind Phase|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
488173|NCT00783094|E1|Reported Event|Tadalafil 2.5 mg - Double-Blind Phase|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
488174|NCT00782834|B1|Baseline|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
488176|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
488177|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
488178|NCT00782834|E1|Reported Event|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
488179|NCT00782821|B5|Baseline|Total|Total of all reporting groups
488180|NCT00782821|B4|Baseline|RATG/Rituxan/Velcade|"Thymoglobulin x 4 doses (1.5mg/kg IV)+ Rituximab 200mg/m2 IV + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
488181|NCT00782821|B3|Baseline|RATG/Velcade|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
488182|NCT00782821|B2|Baseline|RATG/Rituxan|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV)+ Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
488183|NCT00782821|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV) Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily).
488184|NCT00782821|P4|Participant Flow|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses (1.5mg/kg IV). + Rituximab 200mg/m2 IV + Bortezomib 1.3 mg/m2 IVP Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone.
488185|NCT00782821|P3|Participant Flow|RATG/Velcade|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone."
488186|NCT00782821|P2|Participant Flow|RATG/Rituxan|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
488187|NCT00782821|P1|Participant Flow|Rabbit Antithymocyte Globulin (rATG)|"Thymoglobulin x 6 doses (1.5mg/kg IV).~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
488188|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
488189|NCT00782821|O3|Outcome|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
488190|NCT00782821|O2|Outcome|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
488191|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
488192|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
488193|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
488194|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
488195|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV)
488196|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
488197|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Bortezomib
488198|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
488199|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
488200|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
488201|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
488202|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
488203|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
488204|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
488205|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
488206|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
488207|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
488208|NCT00782821|E4|Reported Event|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
488209|NCT00782821|E3|Reported Event|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
488210|NCT00782821|E2|Reported Event|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
488211|NCT00782821|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
488212|NCT00782795|B3|Baseline|Total|Total of all reporting groups
488213|NCT00782795|B2|Baseline|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488214|NCT00782795|B1|Baseline|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488215|NCT00782795|P2|Participant Flow|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488216|NCT00782795|P1|Participant Flow|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488217|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488218|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488219|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488220|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488221|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488222|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488223|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488224|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488225|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488226|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488227|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488228|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488229|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488230|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488231|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488232|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488233|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488234|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488235|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488236|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488237|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488238|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488239|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488240|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488241|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488242|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488243|NCT00782795|O2|Outcome|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488244|NCT00782795|O1|Outcome|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488245|NCT00782795|E2|Reported Event|Sugar Pill (Placebo)|"1 sugar pill (placebo) taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488246|NCT00782795|E1|Reported Event|Pioglitazone|"30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.~Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks."
488247|NCT00782756|B1|Baseline|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
488248|NCT00782756|P1|Participant Flow|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
488249|NCT00782756|O1|Outcome|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
488250|NCT00782756|O1|Outcome|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
488251|NCT00782756|O1|Outcome|RT, With Temozolomide and Bevacizumab|"This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.~Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions."
488252|NCT00782756|E1|Reported Event|RT, With Temozolomide and Bevacizumab|This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
488253|NCT00782717|B3|Baseline|Total|Total of all reporting groups
488254|NCT00782717|B2|Baseline|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488255|NCT00782717|B1|Baseline|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488256|NCT00782717|P2|Participant Flow|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488257|NCT00782717|P1|Participant Flow|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488258|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488259|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488260|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488261|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488262|NCT00782717|E2|Reported Event|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488263|NCT00782717|E1|Reported Event|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
488264|NCT00782639|B3|Baseline|Total|Total of all reporting groups
488265|NCT00782639|B2|Baseline|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488266|NCT00782639|B1|Baseline|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488267|NCT00782639|P2|Participant Flow|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488268|NCT00782639|P1|Participant Flow|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488269|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 milligrams of iodine per milliliter [mgI/mL] concentration)
488270|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 milligrams of iodine per milliliter [mgI/mL] concentration)
488271|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488272|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488273|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488274|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488275|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488276|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488277|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488278|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488279|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488280|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488281|NCT00782639|E2|Reported Event|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
488282|NCT00782639|E1|Reported Event|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
488283|NCT00782626|B1|Baseline|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
488284|NCT00782626|P1|Participant Flow|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
488285|NCT00782626|O1|Outcome|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
488286|NCT00782626|E1|Reported Event|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
488287|NCT00782509|B4|Baseline|Total|Total of all reporting groups
488288|NCT00782509|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488289|NCT00782509|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488290|NCT00782509|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488291|NCT00782509|P3|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488292|NCT00782509|P2|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488293|NCT00782509|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488294|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488295|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488296|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488297|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488298|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488299|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488300|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488301|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488302|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488303|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488304|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488305|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488306|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488307|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488308|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488309|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488310|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488311|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488312|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488313|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
488314|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
488315|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488316|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488317|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488318|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488319|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
488320|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
488321|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488322|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488323|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488324|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488325|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
488326|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
488327|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488328|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488329|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488330|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488331|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488332|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488333|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488334|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488335|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488336|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488337|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488338|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488339|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488340|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488341|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488342|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488343|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488344|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488345|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488346|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488347|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488348|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488349|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488350|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488351|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488352|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488353|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488354|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488355|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488356|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488357|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488358|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488359|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488360|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488361|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488362|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488363|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488364|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488365|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488366|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488367|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488368|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488369|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488370|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488371|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488372|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488373|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488374|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488375|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488376|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488377|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488378|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488379|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488380|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488381|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488382|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488383|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488384|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488385|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488386|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488387|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488388|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488389|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488390|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488391|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488392|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488393|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488394|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488395|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488396|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488397|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488398|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488399|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488400|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488401|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488402|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488403|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488404|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488405|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488406|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488407|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488408|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488409|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488410|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488411|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488412|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488413|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488414|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488415|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488416|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488417|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488418|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488419|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488420|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488421|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488422|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488423|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488424|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488425|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488426|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488427|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488428|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488429|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488430|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488431|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488432|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488433|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488434|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488435|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488436|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488437|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
489932|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
488438|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488439|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488440|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488441|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488442|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488443|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488444|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488445|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488446|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488447|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488448|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488449|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488450|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488451|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488452|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488453|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488454|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488455|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488456|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488457|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488458|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488459|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488460|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488461|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488462|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488463|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488464|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488465|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488466|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488467|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488468|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488469|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488470|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488471|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488472|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488473|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488474|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488475|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488476|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488477|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488478|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488479|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488480|NCT00782509|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488481|NCT00782509|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488482|NCT00782509|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488483|NCT00782496|B3|Baseline|Total|Total of all reporting groups
488484|NCT00782496|B2|Baseline|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
488485|NCT00782496|B1|Baseline|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
488486|NCT00782496|P2|Participant Flow|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
488487|NCT00782496|P1|Participant Flow|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
488488|NCT00782496|O1|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
488489|NCT00782496|O2|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
488490|NCT00782496|O1|Outcome|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
488491|NCT00782496|E2|Reported Event|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
488492|NCT00782496|E1|Reported Event|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
488493|NCT00782483|B1|Baseline|Overall|Overall Study Group
488494|NCT00782483|P1|Participant Flow|Laser Therapy|Total number of participants
488495|NCT00782483|O1|Outcome|Laser Therapy|Total number of participants
488496|NCT00782483|E1|Reported Event|Overall|Overall Study Group
488497|NCT00782418|B1|Baseline|All Patients|All patients from all arms
488498|NCT00782418|P7|Participant Flow|Placebo (HGC or GGI)|Hyperglycemic Clamp or Graded Glucose Infusion: Treatment Group Placebo
488499|NCT00782418|P6|Participant Flow|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
488500|NCT00782418|P5|Participant Flow|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
488501|NCT00782418|P4|Participant Flow|Exenatide 5 ug Down Dosed to Placebo (HGC)|Hyperglycemic Clamp: Treatment Group Exenatide 5 ug down dosed to placebo
488502|NCT00782418|P3|Participant Flow|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
488503|NCT00782418|P2|Participant Flow|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
488504|NCT00782418|P1|Participant Flow|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
488505|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
488506|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
488507|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
488508|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
488509|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
488510|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
488511|NCT00782418|O6|Outcome|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
488512|NCT00782418|O5|Outcome|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
488513|NCT00782418|O4|Outcome|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
488514|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
488515|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
488516|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
488517|NCT00782418|E6|Reported Event|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
488518|NCT00782418|E5|Reported Event|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
488519|NCT00782418|E4|Reported Event|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
488520|NCT00782418|E3|Reported Event|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
488521|NCT00782418|E2|Reported Event|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
488522|NCT00782418|E1|Reported Event|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
488523|NCT00782379|B1|Baseline|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488524|NCT00782379|P1|Participant Flow|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488525|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488526|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488527|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488528|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488529|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488530|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488531|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488532|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488533|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488534|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488535|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488536|NCT00782379|E1|Reported Event|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
488537|NCT00782340|B4|Baseline|Total|Total of all reporting groups
488538|NCT00782340|B3|Baseline|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488539|NCT00782340|B2|Baseline|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488540|NCT00782340|B1|Baseline|Not Randomized|Patients entered open label droxidopa dose titration, but did not proceed into washout and randomization.
488593|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488594|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488541|NCT00782340|P3|Participant Flow|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488542|NCT00782340|P2|Participant Flow|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488543|NCT00782340|P1|Participant Flow|Open-Label Titration|All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.
488544|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488545|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488546|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488547|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488548|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488549|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488550|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488551|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488552|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488553|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488554|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488555|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488556|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488557|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488807|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488558|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488559|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488560|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488561|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488562|NCT00782340|E3|Reported Event|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488563|NCT00782340|E2|Reported Event|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
488564|NCT00782340|E1|Reported Event|Open-Label Titration|All patients treated with study drug during dose titration (7-14 days)
488565|NCT00782288|B4|Baseline|Total|Total of all reporting groups
488566|NCT00782288|B3|Baseline|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488567|NCT00782288|B2|Baseline|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488568|NCT00782288|B1|Baseline|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488569|NCT00782288|P3|Participant Flow|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488570|NCT00782288|P2|Participant Flow|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488571|NCT00782288|P1|Participant Flow|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488572|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488573|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488574|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488575|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488576|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488577|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488578|NCT00782288|O1|Outcome|All Participants|All study participants had nasal cells collected pre and post treatment during the study. Because the data set is extremely large, the full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) this information can be obtained under the accession number.
488579|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488580|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488581|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488582|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488583|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488584|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488585|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488586|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488587|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488588|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488589|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488590|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488591|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488592|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
497270|NCT00762788|B4|Baseline|Balafilcon A Contact Lens|PureVision
488595|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488596|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488597|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488598|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488599|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488600|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488601|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488602|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488603|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488604|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488605|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488606|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488607|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488608|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488609|NCT00782288|E3|Reported Event|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
488610|NCT00782288|E2|Reported Event|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
488611|NCT00782288|E1|Reported Event|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
488612|NCT00782275|B1|Baseline|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
488613|NCT00782275|P1|Participant Flow|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
488614|NCT00782275|O1|Outcome|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
488615|NCT00782275|O1|Outcome|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
488616|NCT00782275|O1|Outcome|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
488617|NCT00782275|E1|Reported Event|Bevacizumab + Temsirolimus|"bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)~temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22~1 cycle=28 days~There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression."
488618|NCT00782210|B4|Baseline|Total|Total of all reporting groups
488619|NCT00782210|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488620|NCT00782210|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488621|NCT00782210|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488622|NCT00782210|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488623|NCT00782210|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488624|NCT00782210|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488625|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488626|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488627|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488628|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
497271|NCT00762788|B3|Baseline|Lotrafilcon B Contact Lens|O2Optix
488629|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488630|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488631|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488632|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488633|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488634|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488635|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488636|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488637|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488638|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488639|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488640|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488641|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488642|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488643|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488644|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
488645|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
488646|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488647|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488648|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488649|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488650|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
488651|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
488652|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488653|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488654|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
488655|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
488656|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
488657|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
488658|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488659|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488660|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488661|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488662|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488663|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488664|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488665|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488666|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488667|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488668|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488669|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488670|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488671|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488672|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488673|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488674|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488675|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488676|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488677|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488678|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488679|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488680|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488681|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488682|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488683|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488684|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488685|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488686|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488687|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488688|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488689|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488690|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488691|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488692|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488693|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488694|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488695|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488696|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488697|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488698|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488699|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488700|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488701|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488702|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488703|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488704|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488705|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488706|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488707|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488708|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488709|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488710|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488711|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488712|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488713|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488714|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488715|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488716|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488717|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488718|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488719|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488720|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488721|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488722|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488723|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488724|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488725|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488726|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488727|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488728|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488729|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488730|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488731|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488732|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488733|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488734|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488735|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488736|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488737|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488738|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488739|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488740|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488741|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488742|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488743|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488744|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488745|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
497272|NCT00762788|B2|Baseline|Lotrafilcon A Contact Lens|NIGHT&DAY
488746|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488747|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488748|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488749|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488750|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488751|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488752|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488753|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488754|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488755|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488756|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488757|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488758|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488759|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488760|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488761|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488762|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488763|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488764|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488765|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488766|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488767|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488768|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488769|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488770|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488771|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488772|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488773|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488774|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488775|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488776|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488777|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488778|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488779|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488780|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488781|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488782|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488783|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488784|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488785|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488786|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488787|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488788|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488789|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488790|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488791|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488792|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488793|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488794|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488795|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488796|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488797|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488798|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488799|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
488800|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488801|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488802|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488803|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488804|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488805|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488806|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
497273|NCT00762788|B1|Baseline|Senofilcon A Contact Lens|ACUVUE OASYS
488808|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488809|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488810|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488811|NCT00782210|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
488812|NCT00782210|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
488813|NCT00782210|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
488814|NCT00782184|B3|Baseline|Total|Total of all reporting groups
488815|NCT00782184|B2|Baseline|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488816|NCT00782184|B1|Baseline|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488817|NCT00782184|P2|Participant Flow|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488818|NCT00782184|P1|Participant Flow|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488819|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488820|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488821|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488822|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488823|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488824|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488825|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488826|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488827|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488828|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488829|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488830|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488831|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488832|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488833|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488834|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488835|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488836|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488837|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488838|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488839|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488840|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488841|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488842|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488843|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488844|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488845|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488846|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488847|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488848|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488849|NCT00782184|E3|Reported Event|Placebo|One participant received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, the participant was randomized to the ezetimbe/simvastatin group, but took only pills from the bottle containing placebo to atorvastatin during the 6-week double-blind treatment period.
488850|NCT00782184|E2|Reported Event|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
488851|NCT00782184|E1|Reported Event|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
488852|NCT00782171|B3|Baseline|Total|Total of all reporting groups
488853|NCT00782171|B2|Baseline|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488854|NCT00782171|B1|Baseline|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488855|NCT00782171|P2|Participant Flow|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488856|NCT00782171|P1|Participant Flow|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488857|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488858|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488859|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488860|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488861|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488862|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488863|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488864|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488865|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488866|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488867|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488868|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488869|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488870|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488871|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488872|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488873|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488874|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488875|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488876|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488877|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488878|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488879|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488880|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488881|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488882|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488883|NCT00782171|O2|Outcome|Early Loading|"Healing caps will be placed on the implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery~SLActive dental implant"
488884|NCT00782171|O1|Outcome|Immediate Loading|"Implant(s) will be restored with a temporary restoration on the day of surgery~SLActive dental implant"
488885|NCT00782171|E2|Reported Event|Early Loading|Healing caps will be placed on the SLActive Implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery
488886|NCT00782171|E1|Reported Event|Immediate Loading|SLActive Implant(s) will be restored with a temporary restoration on the day of surgery.
488887|NCT00782067|B1|Baseline|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
488888|NCT00782067|P1|Participant Flow|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
488889|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
488890|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
488891|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
488892|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
488893|NCT00782067|E1|Reported Event|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
488894|NCT00781963|B4|Baseline|Total|Total of all reporting groups
488895|NCT00781963|B3|Baseline|Control|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488896|NCT00781963|B2|Baseline|Group CBTI|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488897|NCT00781963|B1|Baseline|Individual CBTI|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
488898|NCT00781963|P3|Participant Flow|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488899|NCT00781963|P2|Participant Flow|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488900|NCT00781963|P1|Participant Flow|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
488901|NCT00781963|O3|Outcome|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488902|NCT00781963|O2|Outcome|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488903|NCT00781963|O1|Outcome|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
488904|NCT00781963|E3|Reported Event|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488905|NCT00781963|E2|Reported Event|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
488906|NCT00781963|E1|Reported Event|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
488907|NCT00781950|B3|Baseline|Total|Total of all reporting groups
488908|NCT00781950|B2|Baseline|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
488909|NCT00781950|B1|Baseline|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
488910|NCT00781950|P2|Participant Flow|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
488911|NCT00781950|P1|Participant Flow|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
488912|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
488913|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
488914|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
488915|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.
488916|NCT00781950|E2|Reported Event|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
488917|NCT00781950|E1|Reported Event|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
488918|NCT00781937|B3|Baseline|Total|Total of all reporting groups
488919|NCT00781937|B2|Baseline|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488920|NCT00781937|B1|Baseline|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488921|NCT00781937|P2|Participant Flow|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488922|NCT00781937|P1|Participant Flow|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488923|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488924|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
489028|NCT00781599|B1|Baseline|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
488925|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488926|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488927|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488928|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488929|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488930|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488931|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488932|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488933|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488934|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488935|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488936|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488937|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488938|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
489030|NCT00781599|P1|Participant Flow|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
497274|NCT00762788|P6|Participant Flow|Etafilcon A Contact Lens|ACUVUE 2
488939|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488940|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488941|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488942|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488943|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488944|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488945|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488946|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488947|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488948|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488949|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488950|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488951|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488952|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
489061|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489308|NCT00780026|P1|Participant Flow|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
488953|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488954|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488955|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488956|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488957|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488958|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488959|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488960|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488961|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488962|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488963|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488964|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488965|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488966|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
489062|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
497275|NCT00762788|P5|Participant Flow|Comfilcon A Contact Lens|Biofinity
488967|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488968|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488969|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488970|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488971|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488972|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488973|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488974|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488975|NCT00781937|E2|Reported Event|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
488976|NCT00781937|E1|Reported Event|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
488977|NCT00781911|B3|Baseline|Total|Total of all reporting groups
488978|NCT00781911|B2|Baseline|Islet Cell Carcinoma|"Participants received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488979|NCT00781911|B1|Baseline|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488980|NCT00781911|P2|Participant Flow|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488981|NCT00781911|P1|Participant Flow|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg intravenously (IV) over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489063|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489309|NCT00780026|O2|Outcome|Standard of Care Control|standard of care insulin dosing
497286|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
488982|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488983|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488984|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488985|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488986|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488987|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488988|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488989|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488990|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488991|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488992|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488993|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488994|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study.~Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488995|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488996|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study.~Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489029|NCT00781599|P2|Participant Flow|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
488997|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488998|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
488999|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489000|NCT00781911|O2|Outcome|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489001|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489002|NCT00781911|O2|Outcome|Islet Cell Carcinoma|Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
489003|NCT00781911|O1|Outcome|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489004|NCT00781911|E2|Reported Event|Islet Cell Carcinoma|"Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489005|NCT00781911|E1|Reported Event|Carcinoid Tumor|"Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.~Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen."
489006|NCT00781898|B3|Baseline|Total|Total of all reporting groups
489007|NCT00781898|B2|Baseline|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
489008|NCT00781898|B1|Baseline|Depot Naltrexone|Participants who were randomized to receive Extended Release Naltrexone
489009|NCT00781898|P2|Participant Flow|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
489010|NCT00781898|P1|Participant Flow|Depot Naltrexone|Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
489011|NCT00781898|O2|Outcome|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
489012|NCT00781898|O1|Outcome|Depot Naltrexone|Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
489013|NCT00781898|E2|Reported Event|Placebo|Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
489014|NCT00781898|E1|Reported Event|Depot Naltrexone|Depot naltrexone: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
489015|NCT00781859|B3|Baseline|Total|Total of all reporting groups
489016|NCT00781859|B2|Baseline|Placebo|Intravitreal injection of placebo
489017|NCT00781859|B1|Baseline|Ocriplasmin 125µg|125µg microplasmin intravitreal injection
489018|NCT00781859|P2|Participant Flow|Placebo|Intravitreal injection of placebo
489019|NCT00781859|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
489020|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
489021|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
489022|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
489023|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
489024|NCT00781859|E2|Reported Event|Placebo|Intravitreal injection of placebo
489025|NCT00781859|E1|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
489026|NCT00781599|B3|Baseline|Total|Total of all reporting groups
489027|NCT00781599|B2|Baseline|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
489310|NCT00780026|O1|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489031|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
489032|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
489033|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
489034|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
489035|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
489036|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
489037|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
489038|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
489039|NCT00781599|E2|Reported Event|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
489040|NCT00781599|E1|Reported Event|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
489041|NCT00781508|B3|Baseline|Total|Total of all reporting groups
489042|NCT00781508|B2|Baseline|Placebo First Sildenafil Second|Effect of placebo on left ventricular filling pressures in patients with heart failure
489043|NCT00781508|B1|Baseline|Sildenafil First Placebo Second|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
489044|NCT00781508|P2|Participant Flow|Placebo Then Sildenafil|Effect of Sildenafil on left ventricular function
489045|NCT00781508|P1|Participant Flow|Sildenafil Then Placebo|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
489046|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo orally, then sildenafil 50 mg orally 2 days later.
489047|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|Sildenafil 50 mg orally, placebo orally 2 days later.
489048|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo administered orally, then sildenafil orally 48 hrs later
489049|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|sildenafil 50 mg administered orally, placebo administered orally 48 hrs later
489050|NCT00781508|E2|Reported Event|Placebo First Then Sildenafil|Effect of placebo on left ventricular filing pressures, then effect of sildenafil on left ventricular filling pressure.
489051|NCT00781508|E1|Reported Event|Sildenafil First Then Placebo|Effect of sildenafil first on left ventricular filling pressures, then effect of placebo on left ventricular filling pressure
489052|NCT00781456|B3|Baseline|Total|Total of all reporting groups
489053|NCT00781456|B2|Baseline|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489054|NCT00781456|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489055|NCT00781456|P2|Participant Flow|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489056|NCT00781456|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489057|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489058|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489059|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489060|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
497287|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
489064|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489065|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489066|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489067|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489068|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489069|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489070|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489071|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489072|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489073|NCT00781456|E2|Reported Event|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
489074|NCT00781456|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
489075|NCT00781391|B4|Baseline|Total|Total of all reporting groups
489076|NCT00781391|B3|Baseline|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489077|NCT00781391|B2|Baseline|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489078|NCT00781391|B1|Baseline|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489079|NCT00781391|P3|Participant Flow|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489080|NCT00781391|P2|Participant Flow|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489081|NCT00781391|P1|Participant Flow|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489082|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489083|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489084|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489085|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489086|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489087|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489088|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489089|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489090|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489091|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489311|NCT00780026|O2|Outcome|Standard of Care Control|standard of care insulin dosing
489092|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489093|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489094|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489095|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489096|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489097|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489098|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489099|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489100|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489101|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489102|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489103|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489104|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489105|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489106|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489107|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489108|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489109|NCT00781391|E3|Reported Event|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489110|NCT00781391|E2|Reported Event|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
489111|NCT00781391|E1|Reported Event|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
489112|NCT00781365|B3|Baseline|Total|Total of all reporting groups
489113|NCT00781365|B2|Baseline|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
489114|NCT00781365|B1|Baseline|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
489115|NCT00781365|P2|Participant Flow|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
489116|NCT00781365|P1|Participant Flow|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
489312|NCT00780026|O1|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489313|NCT00780026|O2|Outcome|Standard of Care Control|standard of care insulin dosing
489117|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
489118|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
489119|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
489120|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
489121|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
489122|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
489123|NCT00781365|E2|Reported Event|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
489124|NCT00781365|E1|Reported Event|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
489125|NCT00781326|B1|Baseline|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
489126|NCT00781326|P1|Participant Flow|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
489127|NCT00781326|O1|Outcome|Open Label Antidepressant|"In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.~Nimodipine: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.~Placebo: Placebo will be given in doses matching those of nimodipine."
489128|NCT00781326|E1|Reported Event|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
489129|NCT00781274|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489130|NCT00781274|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489131|NCT00781274|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489132|NCT00781274|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489133|NCT00781079|B3|Baseline|Total|Total of all reporting groups
489134|NCT00781079|B2|Baseline|Arm 2|Care as usual
489135|NCT00781079|B1|Baseline|Arm 1|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
489136|NCT00781079|P2|Participant Flow|Arm 2|Care as usual
489137|NCT00781079|P1|Participant Flow|Arm 1|"Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)~Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA): Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)"
489138|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
489139|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
489140|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
489141|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
489142|NCT00781079|E2|Reported Event|Case as Usual|Care as usual on case management teams
489143|NCT00781079|E1|Reported Event|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
489144|NCT00780962|B3|Baseline|Total|Total of all reporting groups
489314|NCT00780026|O1|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489145|NCT00780962|B2|Baseline|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
489146|NCT00780962|B1|Baseline|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
489147|NCT00780962|P2|Participant Flow|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
489148|NCT00780962|P1|Participant Flow|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
489149|NCT00780962|O2|Outcome|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
489150|NCT00780962|O1|Outcome|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
489151|NCT00780962|E2|Reported Event|0.9% Sodium-chloride Group|Patients in the placebo group received 500 mL of normal saline solution during 30 minutes before contrast administration and a continuous infusion of 67 mL per hour of normal saline solution after contrast administration
489152|NCT00780962|E1|Reported Event|N-Acetycysteine Group|Participants in this group received 3 grams of N-acetylcysteine in 500 cc Normal Saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, participants received a continuous infusion of 200 mg N-acetylcysteine per hour, administered as an infusion of 67 cc per hour of a solution of 3 grams of N-acetylcysteine diluted in a total volume of 1000 cc of normal saline.
489153|NCT00780910|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489154|NCT00780910|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489155|NCT00780910|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489156|NCT00780910|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489157|NCT00780741|B3|Baseline|Total|Total of all reporting groups
489158|NCT00780741|B2|Baseline|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489159|NCT00780741|B1|Baseline|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489160|NCT00780741|P2|Participant Flow|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a surgical facility under general anesthesia within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489161|NCT00780741|P1|Participant Flow|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office setting using topical anesthesia and infant restraint. Probing to be performed either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489162|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489163|NCT00780741|O1|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist.
489164|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489165|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489166|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489167|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489168|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
497288|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
489169|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489170|NCT00780741|E2|Reported Event|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489171|NCT00780741|E1|Reported Event|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
489172|NCT00780715|B5|Baseline|Total|Total of all reporting groups
489173|NCT00780715|B4|Baseline|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
489174|NCT00780715|B3|Baseline|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
489175|NCT00780715|B2|Baseline|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
489176|NCT00780715|B1|Baseline|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
489177|NCT00780715|P4|Participant Flow|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
489178|NCT00780715|P3|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
489179|NCT00780715|P2|Participant Flow|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
489180|NCT00780715|P1|Participant Flow|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
489181|NCT00780715|O4|Outcome|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
489182|NCT00780715|O3|Outcome|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
489183|NCT00780715|O2|Outcome|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
489184|NCT00780715|O1|Outcome|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
489185|NCT00780715|E4|Reported Event|Metformin|Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
489186|NCT00780715|E3|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
489187|NCT00780715|E2|Reported Event|Sitagliptin|Sitagliptin: Sitagliptin 100mg daily for 6 months
489188|NCT00780715|E1|Reported Event|Gliclazide MR|Gliclazide MR: 30mg daily increased to 60mg if HbA1c > 7% at 3 months
489189|NCT00780676|B6|Baseline|Total|Total of all reporting groups
489190|NCT00780676|B5|Baseline|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
489191|NCT00780676|B4|Baseline|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
489192|NCT00780676|B3|Baseline|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489193|NCT00780676|B2|Baseline|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489194|NCT00780676|B1|Baseline|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489195|NCT00780676|P5|Participant Flow|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
489196|NCT00780676|P4|Participant Flow|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway activity predictor positive) receive selumetinib 75 mg by mouth twice daily (BID).
489197|NCT00780676|P3|Participant Flow|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489198|NCT00780676|P2|Participant Flow|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489199|NCT00780676|P1|Participant Flow|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489200|NCT00780676|O3|Outcome|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489201|NCT00780676|O2|Outcome|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489202|NCT00780676|O1|Outcome|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
489203|NCT00780676|E1|Reported Event|Dasatinib 100 mg|Participants with one of 3 predictive gene signatures (dasatinib sensitivity signature, SRC pathway activity signature and dasatinib target index) received Dasatinib 100 mg orally daily.
489204|NCT00780572|B3|Baseline|Total|Total of all reporting groups
489205|NCT00780572|B2|Baseline|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
489206|NCT00780572|B1|Baseline|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
489207|NCT00780572|P2|Participant Flow|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
489208|NCT00780572|P1|Participant Flow|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
489209|NCT00780572|O2|Outcome|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
489210|NCT00780572|O1|Outcome|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
489211|NCT00780572|E2|Reported Event|Arm 2: Control/No Alert|The second arm is the control. Alerts will not be displayed for these patients.
489212|NCT00780572|E1|Reported Event|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
489213|NCT00780481|B1|Baseline|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
489214|NCT00780481|P1|Participant Flow|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
489215|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
489216|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
489217|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
489218|NCT00780481|O1|Outcome|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
489219|NCT00780481|E1|Reported Event|Bradykinin|"Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.~Bradykinin: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose."
489220|NCT00780455|B3|Baseline|Total|Total of all reporting groups
489221|NCT00780455|B2|Baseline|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489222|NCT00780455|B1|Baseline|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489223|NCT00780455|P2|Participant Flow|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489224|NCT00780455|P1|Participant Flow|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489225|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489226|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489315|NCT00780026|O2|Outcome|Standard of Care Control|standard of care insulin dosing
489316|NCT00780026|O1|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489227|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489228|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489229|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489230|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489231|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489232|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489233|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489234|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489235|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489236|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489237|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489238|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489239|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489240|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489241|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489242|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489243|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489244|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489245|NCT00780455|E2|Reported Event|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489246|NCT00780455|E1|Reported Event|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
489247|NCT00780416|B3|Baseline|Total|Total of all reporting groups
489248|NCT00780416|B2|Baseline|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
489249|NCT00780416|B1|Baseline|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489250|NCT00780416|P2|Participant Flow|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
489251|NCT00780416|P1|Participant Flow|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489252|NCT00780416|O2|Outcome|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
489253|NCT00780416|O1|Outcome|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489254|NCT00780416|E2|Reported Event|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
489255|NCT00780416|E1|Reported Event|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
489256|NCT00780403|B1|Baseline|Total Population|All randomized subjects.
489257|NCT00780403|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
489258|NCT00780403|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
489259|NCT00780403|O3|Outcome|No Preference|All randomized subjects.
489260|NCT00780403|O2|Outcome|Zyrtec|All randomized subjects.
489261|NCT00780403|O1|Outcome|RediTab|All randomized subjects.
489262|NCT00780403|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
489263|NCT00780403|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
489264|NCT00780338|B3|Baseline|Total|Total of all reporting groups
489265|NCT00780338|B2|Baseline|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489266|NCT00780338|B1|Baseline|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489267|NCT00780338|P2|Participant Flow|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489268|NCT00780338|P1|Participant Flow|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489269|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489289|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489317|NCT00780026|O2|Outcome|Standard of Care Control|standard of care insulin dosing
489318|NCT00780026|O1|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489319|NCT00780026|O2|Outcome|Standard of Care Control|standard of care insulin dosing
489270|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489271|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
489272|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
489273|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489274|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489275|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
489276|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
489277|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489278|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489279|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489280|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489281|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
489282|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
489283|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
489284|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
489285|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
489286|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
489287|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489288|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489290|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489291|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489292|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489293|NCT00780338|E2|Reported Event|Control|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489294|NCT00780338|E1|Reported Event|AGTO|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
489295|NCT00780273|B1|Baseline|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
489296|NCT00780273|P1|Participant Flow|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
489297|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
489298|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
489299|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
489300|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
489301|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
489302|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
489303|NCT00780273|E1|Reported Event|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study."
489304|NCT00780026|B3|Baseline|Total|Total of all reporting groups
489305|NCT00780026|B2|Baseline|Standard of Care Control|standard of care insulin dosing
489306|NCT00780026|B1|Baseline|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489307|NCT00780026|P2|Participant Flow|Standard of Care Control|standard of care insulin dosing
489320|NCT00780026|O1|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489321|NCT00780026|O2|Outcome|Standard of Care Control|standard of care insulin dosing
489322|NCT00780026|O1|Outcome|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489323|NCT00780026|E2|Reported Event|Standard of Care Control|standard of care insulin dosing
489324|NCT00780026|E1|Reported Event|Strict Glycemic Control|"strict glycemic control (80 to 110 mg/dl)~insulin: bolus or infusion 80 to 110 mg/dl"
489325|NCT00779909|B5|Baseline|Total|Total of all reporting groups
489326|NCT00779909|B4|Baseline|4-Vitamin D3, 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489327|NCT00779909|B3|Baseline|3-Vitamin D3, 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489328|NCT00779909|B2|Baseline|2-Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489329|NCT00779909|B1|Baseline|1-Placebo|placebo oral supplementation once per day for 12 weeks
489330|NCT00779909|P4|Participant Flow|4- Vitamin D3 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489331|NCT00779909|P3|Participant Flow|3- Vitamin D3 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489332|NCT00779909|P2|Participant Flow|2- Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489333|NCT00779909|P1|Participant Flow|1- Placebo|placebo oral supplementation once per day for 12 weeks
489334|NCT00779909|O4|Outcome|4-Vitamin D3, 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489335|NCT00779909|O3|Outcome|3-Vitamin D3, 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489336|NCT00779909|O2|Outcome|2-Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489337|NCT00779909|O1|Outcome|1-Placebo|placebo oral supplementation once per day for 12 weeks
489338|NCT00779909|O4|Outcome|4-Vitamin D3, 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489339|NCT00779909|O3|Outcome|3-Vitamin D3, 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489340|NCT00779909|O2|Outcome|2-Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489341|NCT00779909|O1|Outcome|1-Placebo|placebo oral supplementation once per day for 12 weeks
489342|NCT00779909|O4|Outcome|4-Vitamin D3, 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489343|NCT00779909|O3|Outcome|3-Vitamin D3, 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489344|NCT00779909|O2|Outcome|2-Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489345|NCT00779909|O1|Outcome|1-Placebo|placebo oral supplementation once per day for 12 weeks
489346|NCT00779909|O4|Outcome|4-Vitamin D3, 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489347|NCT00779909|O3|Outcome|3-Vitamin D3, 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489348|NCT00779909|O2|Outcome|2-Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489349|NCT00779909|O1|Outcome|1-Placebo|placebo oral supplementation once per day for 12 weeks
489350|NCT00779909|O4|Outcome|4- Vitamin D3 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489351|NCT00779909|O3|Outcome|3- Vitamin D3 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489352|NCT00779909|O2|Outcome|2- Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489353|NCT00779909|O1|Outcome|1- Placebo|placebo oral supplementation once per day for 12 weeks
489354|NCT00779909|O4|Outcome|4- Vitamin D3 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489355|NCT00779909|O3|Outcome|3- Vitamin D3 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489356|NCT00779909|O2|Outcome|2- Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489357|NCT00779909|O1|Outcome|1- Placebo|placebo oral supplementation once per day for 12 weeks
489358|NCT00779909|O4|Outcome|4- Vitamin D3 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489359|NCT00779909|O3|Outcome|3- Vitamin D3 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489360|NCT00779909|O2|Outcome|2- Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489361|NCT00779909|O1|Outcome|1- Placebo|placebo oral supplementation once per day for 12 weeks
489362|NCT00779909|O4|Outcome|4- Vitamin D3 5000 IU|vitamin D3 5000 IU oral supplementation once per day for 12 weeks
489363|NCT00779909|O3|Outcome|3- Vitamin D3 2500 IU|vitamin D3 2500 IU oral supplementation once per day for 12 weeks
489364|NCT00779909|O2|Outcome|2- Vitamin D3, 500 IU|vitamin D3 500 IU oral supplementation once per day for 12 weeks
489365|NCT00779909|O1|Outcome|1- Placebo|placebo oral supplementation once per day for 12 weeks
489366|NCT00779909|O4|Outcome|4- Vitamin D3 5000 IU|vitamin D3: oral supplementation once per day for 12 weeks
489367|NCT00779909|O3|Outcome|3.Vitamin D3, 2500 IU|vitamin D3: oral supplementation once per day for 12 weeks
489368|NCT00779909|O2|Outcome|2- Vitamin D3, 500 IU|vitamin D3: oral supplementation once per day for 12 weeks
489369|NCT00779909|O1|Outcome|1- Placebo|placebo oral supplementation once per day for 12 weeks
489370|NCT00779909|E4|Reported Event|4- Vitamin D3 5000 IU|vitamin D3, 5000 IU capsule once per day for 12 weeks
489371|NCT00779909|E3|Reported Event|3- Vitamin D3 2500 IU|vitamin D3, 2500 IU capsule once per day for 12 weeks
489372|NCT00779909|E2|Reported Event|2- Vitamin D3, 500 IU|vitamin D3, 500 IU capsule once per day for 12 weeks
489373|NCT00779909|E1|Reported Event|1- Placebo|placebo oral supplementation once per day for 12 weeks
489374|NCT00779857|B1|Baseline|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
489375|NCT00779857|P1|Participant Flow|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
489376|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
489377|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
489378|NCT00779857|E1|Reported Event|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
489379|NCT00779779|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
489380|NCT00779779|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
489381|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
489382|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
489383|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
489384|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
489385|NCT00779779|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
489386|NCT00779766|B3|Baseline|Total|Total of all reporting groups
489387|NCT00779766|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489388|NCT00779766|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489389|NCT00779766|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489390|NCT00779766|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489391|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489392|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489393|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
489394|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489395|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489396|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489397|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489398|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489399|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
489400|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
489401|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489402|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489403|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489404|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489405|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489406|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
497289|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
489407|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489408|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489409|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489410|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489411|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489412|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489413|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489414|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489415|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489416|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489417|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489418|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489419|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489420|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489421|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489422|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489423|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489424|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489425|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489426|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489427|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489428|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489429|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489430|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489431|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489432|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489433|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489434|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489435|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489436|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489437|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489763|NCT00779025|B1|Baseline|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
497290|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
489438|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489439|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489440|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489441|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489442|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489443|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489444|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489445|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489446|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489447|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489448|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489449|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489450|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489451|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489452|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489453|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489454|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489455|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489456|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489457|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489458|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489459|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489460|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489461|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489462|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489463|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489464|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489465|NCT00779766|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489466|NCT00779766|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
489467|NCT00779701|B1|Baseline|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
489468|NCT00779701|P1|Participant Flow|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
489469|NCT00779701|O1|Outcome|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
489470|NCT00779701|E1|Reported Event|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
489471|NCT00779675|B1|Baseline|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489472|NCT00779675|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489473|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489474|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489475|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489476|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489477|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489478|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
489479|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
489480|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
489481|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
489482|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Week 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characterisitics (SPC; European Union), or local labelling (for all other countries).
489483|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2,6, and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries)
489484|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries).
489485|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489486|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489511|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
497291|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
489487|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489488|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489489|NCT00779675|E1|Reported Event|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
489490|NCT00779584|B10|Baseline|Total|Total of all reporting groups
489491|NCT00779584|B9|Baseline|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489492|NCT00779584|B8|Baseline|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489493|NCT00779584|B7|Baseline|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489494|NCT00779584|B6|Baseline|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489495|NCT00779584|B5|Baseline|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489496|NCT00779584|B4|Baseline|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489497|NCT00779584|B3|Baseline|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489498|NCT00779584|B2|Baseline|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489499|NCT00779584|B1|Baseline|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489500|NCT00779584|P9|Participant Flow|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489501|NCT00779584|P8|Participant Flow|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489502|NCT00779584|P7|Participant Flow|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489503|NCT00779584|P6|Participant Flow|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489504|NCT00779584|P5|Participant Flow|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489505|NCT00779584|P4|Participant Flow|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489506|NCT00779584|P3|Participant Flow|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489507|NCT00779584|P2|Participant Flow|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489508|NCT00779584|P1|Participant Flow|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an intravenous (IV) infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489509|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489510|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489512|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489513|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489514|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489515|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489516|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489517|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489518|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489519|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489520|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489521|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489522|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489523|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489524|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489525|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489526|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489527|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489528|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489529|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489530|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489531|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489532|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489533|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489534|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489535|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489536|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489537|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489538|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489539|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489540|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489541|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489542|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489543|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489544|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489545|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489546|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489547|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489548|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489549|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489550|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489551|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489552|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489553|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489554|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489555|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489556|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489557|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489558|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489559|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489560|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489561|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489562|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489563|NCT00779584|O9|Outcome|MK-8776 200mg+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489564|NCT00779584|O8|Outcome|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489565|NCT00779584|O7|Outcome|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489566|NCT00779584|O6|Outcome|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489567|NCT00779584|O5|Outcome|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489568|NCT00779584|O4|Outcome|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489569|NCT00779584|O3|Outcome|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489570|NCT00779584|O2|Outcome|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489571|NCT00779584|O1|Outcome|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489572|NCT00779584|E9|Reported Event|MK-8776 200mg Flat Dose+Gemcitabine 1000mg/m^2|Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489573|NCT00779584|E8|Reported Event|MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489574|NCT00779584|E7|Reported Event|MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489575|NCT00779584|E6|Reported Event|MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489576|NCT00779584|E5|Reported Event|MK-8776 112mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489577|NCT00779584|E4|Reported Event|MK-8776 80mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489578|NCT00779584|E3|Reported Event|MK-8776 40mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489579|NCT00779584|E2|Reported Event|MK-8776 20mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489580|NCT00779584|E1|Reported Event|MK-8776 10mg/m^2+Gemcitabine 800mg/m^2|Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
489581|NCT00779558|B3|Baseline|Total|Total of all reporting groups
489582|NCT00779558|B2|Baseline|Placebo|Placebo - normal saline infusion
489583|NCT00779558|B1|Baseline|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489584|NCT00779558|P2|Participant Flow|Placebo|Placebo - normal saline infusion
489585|NCT00779558|P1|Participant Flow|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489586|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
489587|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489588|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
489589|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489590|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
489591|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489593|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489594|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
489595|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489596|NCT00779558|E2|Reported Event|Placebo|Placebo - normal saline infusion
489597|NCT00779558|E1|Reported Event|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
489598|NCT00779506|B1|Baseline|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489599|NCT00779506|P1|Participant Flow|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489600|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489601|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489602|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489603|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489604|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489605|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489606|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489607|NCT00779506|E1|Reported Event|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
489608|NCT00779467|B5|Baseline|Total|Total of all reporting groups
489609|NCT00779467|B4|Baseline|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489610|NCT00779467|B3|Baseline|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489611|NCT00779467|B2|Baseline|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489612|NCT00779467|B1|Baseline|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489613|NCT00779467|P4|Participant Flow|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489614|NCT00779467|P3|Participant Flow|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489615|NCT00779467|P2|Participant Flow|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489616|NCT00779467|P1|Participant Flow|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489617|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489618|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489619|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489620|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489621|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489622|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489764|NCT00779025|P1|Participant Flow|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
489623|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489624|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489625|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489626|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489627|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489628|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489629|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489630|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489631|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489632|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489633|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489634|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489635|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489636|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489637|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489638|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489639|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489640|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489641|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489642|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489643|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489644|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489645|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489646|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489647|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489648|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489649|NCT00779467|E4|Reported Event|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
489650|NCT00779467|E3|Reported Event|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489710|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
489651|NCT00779467|E2|Reported Event|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489652|NCT00779467|E1|Reported Event|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
489653|NCT00779402|B3|Baseline|Total|Total of all reporting groups
489654|NCT00779402|B2|Baseline|Control|"Control~Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen"
489655|NCT00779402|B1|Baseline|Sipuleucel-T|"Provenge~Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF"
489656|NCT00779402|P2|Participant Flow|Control|"Control~Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen"
489657|NCT00779402|P1|Participant Flow|Sipuleucel-T|"Provenge~Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF"
489658|NCT00779402|O2|Outcome|Control|Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.
489659|NCT00779402|O1|Outcome|Sipuleucel-T|Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
489660|NCT00779402|O2|Outcome|Control|Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.
489661|NCT00779402|O1|Outcome|Sipuleucel-T|Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
489662|NCT00779402|E2|Reported Event|Control|"Control~Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen"
489663|NCT00779402|E1|Reported Event|Sipuleucel-T|"Provenge~Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF"
489664|NCT00779311|B6|Baseline|Total|Total of all reporting groups
489665|NCT00779311|B5|Baseline|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
489666|NCT00779311|B4|Baseline|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
489667|NCT00779311|B3|Baseline|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
489668|NCT00779311|B2|Baseline|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
489669|NCT00779311|B1|Baseline|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
489670|NCT00779311|P5|Participant Flow|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
489671|NCT00779311|P4|Participant Flow|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
489672|NCT00779311|P3|Participant Flow|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
489673|NCT00779311|P2|Participant Flow|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
489674|NCT00779311|P1|Participant Flow|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
489675|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
489676|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
489677|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
489678|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
489679|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
489680|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
489681|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
489765|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
489682|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
489683|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
489684|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
489685|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
489686|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
489687|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
489688|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
489689|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
489690|NCT00779311|E5|Reported Event|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
489691|NCT00779311|E4|Reported Event|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
489692|NCT00779311|E3|Reported Event|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
489693|NCT00779311|E2|Reported Event|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
489694|NCT00779311|E1|Reported Event|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
489695|NCT00779285|B1|Baseline|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
489696|NCT00779285|P1|Participant Flow|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
489697|NCT00779285|O1|Outcome|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
489698|NCT00779285|E1|Reported Event|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
489699|NCT00779259|B1|Baseline|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
489700|NCT00779259|P1|Participant Flow|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
489701|NCT00779259|O2|Outcome|4 Hours After Co-Administered Dose of Theophylline/Quinine|measured 4 hours after the 7 am co-administered dose of theophylline and quinine
489702|NCT00779259|O1|Outcome|1 Hour Before Co-Administered Dose of Theophylline/Quinine|measured 1 hour prior to the 7 am co-administered dose of theophylline and quinine
489703|NCT00779259|O2|Outcome|4 Hours After Morning Dose of Quinine on Study Day 11|measured 4 hours after the morning dose of quinine
489704|NCT00779259|O1|Outcome|1 Hour Before Morning Dose of Quinine on Study Day 11|measured 1 hour prior to the morning dose of Quinine on study Day 11
489705|NCT00779259|O2|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
489706|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
489707|NCT00779259|O4|Outcome|Quinine in Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
489708|NCT00779259|O3|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
489709|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
489766|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
489711|NCT00779259|O4|Outcome|Quinine in the Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
489712|NCT00779259|O3|Outcome|Theophylline in the Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
489713|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11.
489714|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration)followed by a 4-day washout period.
489715|NCT00779259|E3|Reported Event|Theophylline Co-administered With Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml) and quinine sulfate (2 x 324 mg capsules).
489716|NCT00779259|E2|Reported Event|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
489717|NCT00779259|E1|Reported Event|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml)followed by a 4 day washout period
489718|NCT00779246|B3|Baseline|Total|Total of all reporting groups
489719|NCT00779246|B2|Baseline|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
489720|NCT00779246|B1|Baseline|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
489721|NCT00779246|P2|Participant Flow|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
489722|NCT00779246|P1|Participant Flow|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
489723|NCT00779246|O2|Outcome|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
489724|NCT00779246|O1|Outcome|Active Surveillance Cultures (ASC)|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
489725|NCT00779246|O2|Outcome|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
489726|NCT00779246|O1|Outcome|Active Surveillance Cultures (ASC)|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
489727|NCT00779246|O2|Outcome|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
489728|NCT00779246|O1|Outcome|Active Surveillance Cultures (ASC)|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
489729|NCT00779246|E2|Reported Event|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
489730|NCT00779246|E1|Reported Event|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
489731|NCT00779155|B3|Baseline|Total|Total of all reporting groups
489732|NCT00779155|B2|Baseline|Active Resonator Device|Active pico-tesla magnetic fields
489733|NCT00779155|B1|Baseline|Inactive Resonator Device|inactive magnetic fields with placebo fields
489734|NCT00779155|P2|Participant Flow|Active Resonator Device|Active pico-tesla magnetic fields
489735|NCT00779155|P1|Participant Flow|Inactive Resonator Device|inactive magnetic fields with placebo fields
489736|NCT00779155|O2|Outcome|Active Resonator Device|Active pico-tesla magnetic fields
489737|NCT00779155|O1|Outcome|Inactive Resonator Device|inactive magnetic fields with placebo fields
489738|NCT00779155|E2|Reported Event|Active Resonator Device|Active pico-tesla magnetic fields
489739|NCT00779155|E1|Reported Event|Inactive Resonator Device|inactive magnetic fields with placebo fields
489740|NCT00779142|B1|Baseline|Methotrexate 25mg/ml|Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
489762|NCT00779038|E1|Reported Event|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
497292|NCT00762788|E6|Reported Event|Etafilcon A Contact Lens|ACUVUE 2
489741|NCT00779142|P1|Participant Flow|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
489742|NCT00779142|O1|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
489743|NCT00779142|O1|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose to subjects with diabetic macular edema resistant to conventional therapies.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
489744|NCT00779142|O1|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
489745|NCT00779142|E1|Reported Event|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
489746|NCT00779116|B1|Baseline|Total Population|All randomized subjects
489747|NCT00779116|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab.
489748|NCT00779116|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet.
489749|NCT00779116|O3|Outcome|No Preference|All randomized subjects.
489750|NCT00779116|O2|Outcome|Zyrtec|All randomized subjects.
489751|NCT00779116|O1|Outcome|RediTab|All randomized subjects.
489752|NCT00779116|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab (first and second intervention period).
489753|NCT00779116|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
489754|NCT00779038|B1|Baseline|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
489755|NCT00779038|P1|Participant Flow|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
489756|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
489757|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
489758|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
489759|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
489760|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
489761|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
490496|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
489767|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
489768|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
489769|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
489770|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
489771|NCT00779025|E1|Reported Event|Overall Study|
489772|NCT00778999|B3|Baseline|Total|Total of all reporting groups
489773|NCT00778999|B2|Baseline|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
489774|NCT00778999|B1|Baseline|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
489775|NCT00778999|P2|Participant Flow|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
489776|NCT00778999|P1|Participant Flow|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
489777|NCT00778999|O2|Outcome|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
489778|NCT00778999|O1|Outcome|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
489779|NCT00778999|E2|Reported Event|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
489780|NCT00778999|E1|Reported Event|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
489781|NCT00778921|B4|Baseline|Total|Total of all reporting groups
489782|NCT00778921|B3|Baseline|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
489783|NCT00778921|B2|Baseline|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
489784|NCT00778921|B1|Baseline|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
489785|NCT00778921|P3|Participant Flow|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
489786|NCT00778921|P2|Participant Flow|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
489787|NCT00778921|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
489788|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
489789|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
489790|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
489791|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
489792|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
489793|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
489794|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
489795|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
489796|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
489797|NCT00778921|E3|Reported Event|Amlodipine 10mg|Amlodipine 10mg
489798|NCT00778921|E2|Reported Event|Aliskiren 150mg/ Amlodipine 10mg|Aliskiren 150mg/ Amlodipine 10mg
489799|NCT00778921|E1|Reported Event|Aliskiren 300mg/ Amlodipine 10mg|Aliskiren 300mg/ Amlodipine 10mg
489800|NCT00778895|B4|Baseline|Total|Total of all reporting groups
489801|NCT00778895|B3|Baseline|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489802|NCT00778895|B2|Baseline|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489803|NCT00778895|B1|Baseline|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489804|NCT00778895|P3|Participant Flow|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489805|NCT00778895|P2|Participant Flow|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489806|NCT00778895|P1|Participant Flow|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489845|NCT00778869|O1|Outcome|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54 in participants with AS.
489807|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489808|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489809|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489810|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489811|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489812|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489813|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489814|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489815|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489816|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489817|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489818|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489819|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489820|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489821|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489822|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489823|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489824|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489825|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489826|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489827|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489828|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489829|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489830|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489831|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489832|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489833|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489834|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489835|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489836|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489837|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489838|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489839|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489840|NCT00778895|E3|Reported Event|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489841|NCT00778895|E2|Reported Event|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489842|NCT00778895|E1|Reported Event|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
489843|NCT00778869|B1|Baseline|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
489844|NCT00778869|P1|Participant Flow|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
497293|NCT00762788|E5|Reported Event|Comfilcon A Contact Lens|Biofinity
489846|NCT00778869|E1|Reported Event|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
489847|NCT00778830|B3|Baseline|Total|Total of all reporting groups
489848|NCT00778830|B2|Baseline|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489849|NCT00778830|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489850|NCT00778830|P2|Participant Flow|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489851|NCT00778830|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489852|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489853|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489854|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489855|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489856|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489857|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489858|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489859|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
489927|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489860|NCT00778830|E2|Reported Event|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Oxaliplatin was administered intravenously at a dose of 100 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
489861|NCT00778830|E1|Reported Event|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Irinotecan was administered intravenously at a dose of 180 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
489862|NCT00778817|B1|Baseline|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489863|NCT00778817|P1|Participant Flow|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489864|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489865|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489866|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489867|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489868|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489869|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489870|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489871|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489872|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489873|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489874|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489875|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489876|NCT00778817|E1|Reported Event|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
489877|NCT00778648|B3|Baseline|Total|Total of all reporting groups
489878|NCT00778648|B2|Baseline|Placebo|
489879|NCT00778648|B1|Baseline|Juice Plus|
489880|NCT00778648|P2|Participant Flow|Placebo|
489881|NCT00778648|P1|Participant Flow|Juice Plus|
489882|NCT00778648|O2|Outcome|Placebo|
489883|NCT00778648|O1|Outcome|Juice Plus|
489884|NCT00778648|E2|Reported Event|Placebo|
489885|NCT00778648|E1|Reported Event|Juice Plus|
489886|NCT00778622|B4|Baseline|Total|Total of all reporting groups
489887|NCT00778622|B3|Baseline|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
489888|NCT00778622|B2|Baseline|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
489889|NCT00778622|B1|Baseline|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
489928|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489929|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489930|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489931|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489890|NCT00778622|P3|Participant Flow|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to (>=) 28 kg/m^2. Initial dose of Glucophage extended release (XR)on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
489891|NCT00778622|P2|Participant Flow|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to (>=) 24 kg/m^2 and less than (<) 28 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
489892|NCT00778622|P1|Participant Flow|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to (>=)18.5 kilogram per meter squared (kg/m^2) and less than (<) 24 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks.
489893|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
489894|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
489895|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
489896|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489897|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489898|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489899|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489900|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489901|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489902|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489903|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489904|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489905|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489906|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489907|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489908|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489909|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489910|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489911|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489912|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489913|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489914|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489915|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489916|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489917|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489918|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489919|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489920|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489921|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489922|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489923|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489924|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489925|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489926|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
497294|NCT00762788|E4|Reported Event|Balafilcon A Contact Lens|PureVision
489933|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489934|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489935|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489936|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489937|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489938|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489939|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489940|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 .
489941|NCT00778622|E3|Reported Event|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
489942|NCT00778622|E2|Reported Event|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
489943|NCT00778622|E1|Reported Event|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
489944|NCT00778375|B1|Baseline|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489945|NCT00778375|P1|Participant Flow|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 by vein (IV) as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489946|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489947|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489948|NCT00778375|O2|Outcome|Re-Induction|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489949|NCT00778375|O1|Outcome|Induction Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489950|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489951|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489952|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489953|NCT00778375|E1|Reported Event|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
489954|NCT00778336|B5|Baseline|Total|Total of all reporting groups
489955|NCT00778336|B4|Baseline|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
489956|NCT00778336|B3|Baseline|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
489957|NCT00778336|B2|Baseline|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
489958|NCT00778336|B1|Baseline|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
489959|NCT00778336|P4|Participant Flow|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
489960|NCT00778336|P3|Participant Flow|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
489961|NCT00778336|P2|Participant Flow|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
489962|NCT00778336|P1|Participant Flow|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
489963|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
489964|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
489965|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
489966|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
489967|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
489968|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
497295|NCT00762788|E3|Reported Event|Lotrafilcon B Contact Lens|O2Optix
489969|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
489970|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
489971|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
489972|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
489973|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
489974|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
489975|NCT00778336|E4|Reported Event|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
489976|NCT00778336|E3|Reported Event|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
489977|NCT00778336|E2|Reported Event|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
489978|NCT00778336|E1|Reported Event|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
489979|NCT00778310|B3|Baseline|Total|Total of all reporting groups
489980|NCT00778310|B2|Baseline|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
489981|NCT00778310|B1|Baseline|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
489982|NCT00778310|P2|Participant Flow|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
489983|NCT00778310|P1|Participant Flow|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
489984|NCT00778310|O4|Outcome|Children Placebo Condition|This is the BOLD signal data on the Placebo day scan.
489985|NCT00778310|O3|Outcome|Children Drug Condition|This is the BOLD signal data on the Concerta day scan.
489986|NCT00778310|O2|Outcome|Adults Placebo Condition|This is the BOLD signal data on the Placebo day scan.
489987|NCT00778310|O1|Outcome|Adults Drug Condition|This is the BOLD signal data on the Concerta day scan.
489988|NCT00778310|E2|Reported Event|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
489989|NCT00778310|E1|Reported Event|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
489990|NCT00778258|B10|Baseline|Total|Total of all reporting groups
489991|NCT00778258|B9|Baseline|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
489992|NCT00778258|B8|Baseline|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
489993|NCT00778258|B7|Baseline|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
489994|NCT00778258|B6|Baseline|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
489995|NCT00778258|B5|Baseline|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
489996|NCT00778258|B4|Baseline|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
489997|NCT00778258|B3|Baseline|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
489998|NCT00778258|B2|Baseline|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
489999|NCT00778258|B1|Baseline|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490000|NCT00778258|P9|Participant Flow|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
490001|NCT00778258|P8|Participant Flow|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
490002|NCT00778258|P7|Participant Flow|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
490003|NCT00778258|P6|Participant Flow|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490004|NCT00778258|P5|Participant Flow|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490005|NCT00778258|P4|Participant Flow|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490006|NCT00778258|P3|Participant Flow|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490007|NCT00778258|P2|Participant Flow|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490140|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
490008|NCT00778258|P1|Participant Flow|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490009|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
490010|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
490011|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
490012|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
490013|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
490014|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
490015|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
490016|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
490017|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
490018|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
490019|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
490020|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
490021|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
490022|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
490023|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
490024|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
490025|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
490026|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
490027|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
490028|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
490029|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
490030|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
490031|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
490032|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
490033|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
490034|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
490035|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
490036|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
490037|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
490038|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
490039|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
490040|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
490041|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
490042|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
490043|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
490044|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
490045|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
490046|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
490141|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
490047|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
490048|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
490049|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
490050|NCT00778258|E9|Reported Event|Non-Randomized - Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
490051|NCT00778258|E8|Reported Event|Non-Randomized - Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
490052|NCT00778258|E7|Reported Event|Not Randomized - Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
490053|NCT00778258|E6|Reported Event|Maintenance - Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490054|NCT00778258|E5|Reported Event|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490055|NCT00778258|E4|Reported Event|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490056|NCT00778258|E3|Reported Event|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490057|NCT00778258|E2|Reported Event|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490058|NCT00778258|E1|Reported Event|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
490059|NCT00778167|B4|Baseline|Total|Total of all reporting groups
490060|NCT00778167|B3|Baseline|Cohort 3|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
490061|NCT00778167|B2|Baseline|Cohort 2|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490062|NCT00778167|B1|Baseline|Cohort 1|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490063|NCT00778167|P3|Participant Flow|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
490064|NCT00778167|P2|Participant Flow|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490065|NCT00778167|P1|Participant Flow|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490066|NCT00778167|O3|Outcome|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
490067|NCT00778167|O2|Outcome|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490068|NCT00778167|O1|Outcome|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490069|NCT00778167|E3|Reported Event|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
490070|NCT00778167|E2|Reported Event|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490071|NCT00778167|E1|Reported Event|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
490072|NCT00778102|B3|Baseline|Total|Total of all reporting groups
490073|NCT00778102|B2|Baseline|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490074|NCT00778102|B1|Baseline|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490075|NCT00778102|P2|Participant Flow|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, irinotecan, leucovorin, and 5-FU (FOLFOXIRI). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490076|NCT00778102|P1|Participant Flow|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX-6). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 milligrams per kilogram (mg/kg) via intravenous (IV) infusion; oxaliplatin 85 milligrams per meter-squared (mg/m^2) via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, progressive disease (PD), unacceptable toxicity, or participant refusal.
490077|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490078|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490079|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490080|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490081|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490142|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
490143|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
490082|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490083|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490084|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490085|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490086|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490087|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490088|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490089|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490090|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490091|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490092|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490093|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490497|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
490094|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490095|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490096|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490097|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490098|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490099|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490100|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490101|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490102|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490103|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490104|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490105|NCT00778102|E2|Reported Event|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490498|NCT00777023|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
490106|NCT00778102|E1|Reported Event|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
490107|NCT00777946|B4|Baseline|Total|Total of all reporting groups
490108|NCT00777946|B3|Baseline|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490109|NCT00777946|B2|Baseline|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490110|NCT00777946|B1|Baseline|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490111|NCT00777946|P3|Participant Flow|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490112|NCT00777946|P2|Participant Flow|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490113|NCT00777946|P1|Participant Flow|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490114|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490115|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490116|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490117|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490118|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490119|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490120|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490121|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490122|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490123|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490124|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490125|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490126|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490127|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490128|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490129|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490130|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490131|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490132|NCT00777946|E3|Reported Event|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
490133|NCT00777946|E2|Reported Event|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490134|NCT00777946|E1|Reported Event|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
490135|NCT00777855|B1|Baseline|Entire Study Population|Includes participants randomized to receive warfarin alone then warfarin+rifampin, and those randomized to receive warfarin+rifampin then warfarin alone in the crossover design
490136|NCT00777855|P2|Participant Flow|Warfarin+Rifampin First, Then Warfarin Alone|In a randomized, single-dose, two-period, crossover design, 5 participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po; after a minimum of 14 days, participants received warfarin alone 7.5mg po.
490137|NCT00777855|P1|Participant Flow|Warfarin First, Then Warfarin+Rifampin|In a randomized, single-dose, two-period, crossover design, 5 participants received warfarin alone 7.5mg po; after a minimum of 14 days, participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po.
490138|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
490139|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
490144|NCT00777855|E1|Reported Event|Entire Study Population|Each of 10 participants received both study treatments, in randomly assigned sequence, separated by a minimum of 14 days
490145|NCT00777803|B3|Baseline|Total|Total of all reporting groups
490146|NCT00777803|B2|Baseline|OnabotulinumtoxinA (Vistabel®)|
490147|NCT00777803|B1|Baseline|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490148|NCT00777803|P2|Participant Flow|OnabotulinumtoxinA (Vistabel®)|
490149|NCT00777803|P1|Participant Flow|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490150|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490151|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490152|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490153|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490154|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490155|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490156|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490157|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490158|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490159|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490160|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490161|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490162|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490163|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490164|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490165|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490166|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490167|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490168|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490169|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490170|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490171|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490172|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490173|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490174|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490175|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490176|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
490177|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490178|NCT00777803|E2|Reported Event|OnabotulinumtoxinA (Vistabel®)|
490179|NCT00777803|E1|Reported Event|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
490180|NCT00777790|B4|Baseline|Total|Total of all reporting groups
490181|NCT00777790|B3|Baseline|Control Group|Meningococcal vaccine-naïve subjects
490182|NCT00777790|B2|Baseline|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
490183|NCT00777790|B1|Baseline|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
490184|NCT00777790|P3|Participant Flow|Control Group|Meningococcal vaccine-naïve subjects
490185|NCT00777790|P2|Participant Flow|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
490186|NCT00777790|P1|Participant Flow|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
490187|NCT00777790|O3|Outcome|Control Group|Meningococcal vaccine-naïve subjects
490188|NCT00777790|O2|Outcome|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
490189|NCT00777790|O1|Outcome|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
490190|NCT00777790|E3|Reported Event|Control Group|Meningococcal vaccine-naïve subjects
490191|NCT00777790|E2|Reported Event|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
490192|NCT00777790|E1|Reported Event|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
490193|NCT00777764|B3|Baseline|Total|Total of all reporting groups
490194|NCT00777764|B2|Baseline|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
490195|NCT00777764|B1|Baseline|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
490196|NCT00777764|P2|Participant Flow|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
490222|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490223|NCT00777634|E2|Reported Event|Without BED|Individuals who do not meet criteria for binge eating disorder.
490197|NCT00777764|P1|Participant Flow|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
490198|NCT00777764|O1|Outcome|Patients With Allergic Asthma|
490199|NCT00777764|O1|Outcome|Healthy Subjects|
490200|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
490201|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
490202|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
490203|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
490204|NCT00777764|E2|Reported Event|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
490205|NCT00777764|E1|Reported Event|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
490206|NCT00777634|B3|Baseline|Total|Total of all reporting groups
490207|NCT00777634|B2|Baseline|Without BED|Individuals who do not meet criteria for binge eating disorder.
490208|NCT00777634|B1|Baseline|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490209|NCT00777634|P2|Participant Flow|Without BED|Individuals who do not meet criteria for binge eating disorder.
490210|NCT00777634|P1|Participant Flow|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490211|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
490212|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490213|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
490214|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490215|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
490216|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490217|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
490218|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490219|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
490220|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490221|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
490224|NCT00777634|E1|Reported Event|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
490225|NCT00777608|B3|Baseline|Total|Total of all reporting groups
490226|NCT00777608|B2|Baseline|Placebo|Participants were randomized to placebo for 84 days
490227|NCT00777608|B1|Baseline|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
490228|NCT00777608|P2|Participant Flow|Placebo|Participants were randomized to placebo for 84 days
490229|NCT00777608|P1|Participant Flow|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
490230|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
490231|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
490232|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
490233|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
490234|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
490235|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
490236|NCT00777608|E2|Reported Event|Placebo|Participants were randomized to placebo for 84 days
490237|NCT00777608|E1|Reported Event|Donezepil 5-10 mg|Participants were randomized to donepezil for 84 days
490238|NCT00777556|B1|Baseline|DR-104|One tablet for emergency contraception
490239|NCT00777556|P1|Participant Flow|DR-104|One tablet for emergency contraception
490240|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
490241|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
490242|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
490243|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
490244|NCT00777556|E1|Reported Event|DR-104|One tablet for emergency contraception
490245|NCT00777335|B3|Baseline|Total|Total of all reporting groups
490246|NCT00777335|B2|Baseline|Panobinostat Oral|
490247|NCT00777335|B1|Baseline|Panobinostat Intra-venous (i.v.)|
490248|NCT00777335|P2|Participant Flow|Panobinostat Oral|
490249|NCT00777335|P1|Participant Flow|Panobinostat Intra-venous (i.v.)|
490250|NCT00777335|O2|Outcome|Panobinostat Oral|
490251|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
490252|NCT00777335|O2|Outcome|Panobinostat Oral|
490253|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
490254|NCT00777335|E2|Reported Event|Panobinostat Oral|
490255|NCT00777335|E1|Reported Event|Panobinostat Intra-venous (i.v.)|
490256|NCT00777257|B4|Baseline|Total|Total of all reporting groups
490257|NCT00777257|B3|Baseline|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
490258|NCT00777257|B2|Baseline|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
490259|NCT00777257|B1|Baseline|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
490260|NCT00777257|P3|Participant Flow|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
490261|NCT00777257|P2|Participant Flow|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
490262|NCT00777257|P1|Participant Flow|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
490263|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
490264|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
490265|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
490266|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
490267|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
490268|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
490269|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
490270|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
490271|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
490272|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
490273|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
490274|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
490275|NCT00777257|E3|Reported Event|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
490276|NCT00777257|E2|Reported Event|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
490277|NCT00777257|E1|Reported Event|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
490278|NCT00777205|B3|Baseline|Total|Total of all reporting groups
490419|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490279|NCT00777205|B2|Baseline|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490280|NCT00777205|B1|Baseline|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490281|NCT00777205|P2|Participant Flow|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490282|NCT00777205|P1|Participant Flow|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
490283|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490284|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
490285|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490286|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
490287|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490288|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490289|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490290|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490291|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490499|NCT00777023|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
490292|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490293|NCT00777205|E2|Reported Event|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
490294|NCT00777205|E1|Reported Event|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
490295|NCT00777179|B3|Baseline|Total|Total of all reporting groups
490296|NCT00777179|B2|Baseline|Placebo|Matching Placebo
490297|NCT00777179|B1|Baseline|Vandetanib|Vandetanib 300 mg, orally, once daily
490298|NCT00777179|P2|Participant Flow|Placebo|Matching Placebo
490299|NCT00777179|P1|Participant Flow|Vandetanib|Vandetanib 300 mg, orally, once daily
490300|NCT00777179|O2|Outcome|Placebo|Matching Placebo
490301|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
490302|NCT00777179|O2|Outcome|Placebo|Matching Placebo
490303|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
490304|NCT00777179|O2|Outcome|Placebo|Matching Placebo
490305|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
490306|NCT00777179|O2|Outcome|Placebo|Matching Placebo
490307|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
490308|NCT00777179|O2|Outcome|Placebo|Matching Placebo
490309|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
490310|NCT00777179|E2|Reported Event|Placebo|Matching Placebo
490311|NCT00777179|E1|Reported Event|Vandetanib|Vandetanib 300 mg, orally, once daily
490312|NCT00777153|B4|Baseline|Total|Total of all reporting groups
490313|NCT00777153|B3|Baseline|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490314|NCT00777153|B2|Baseline|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490315|NCT00777153|B1|Baseline|Cediranib 30mg|Cediranib 30mg/Day
490316|NCT00777153|P3|Participant Flow|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490317|NCT00777153|P2|Participant Flow|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490318|NCT00777153|P1|Participant Flow|Cediranib 30mg|Cediranib 30mg/Day
490319|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490320|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 119mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490321|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
490322|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490323|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490324|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
490325|NCT00777153|O3|Outcome|Lomustine 100mg|Lomustine 110mg/m2/Day + Placebo cediranib
490326|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 100mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490327|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
490328|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490329|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490330|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
490331|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490332|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490333|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
490334|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490335|NCT00777153|O2|Outcome|Cediranib 20mg+ Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490336|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
490337|NCT00777153|E3|Reported Event|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
490338|NCT00777153|E2|Reported Event|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
490339|NCT00777153|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/Day
490340|NCT00777101|B3|Baseline|Total|Total of all reporting groups
490341|NCT00777101|B2|Baseline|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490342|NCT00777101|B1|Baseline|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490343|NCT00777101|P2|Participant Flow|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490344|NCT00777101|P1|Participant Flow|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490345|NCT00777101|O2|Outcome|Lapatinib+Capecitabine|"Lapatinib+Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490346|NCT00777101|O1|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490500|NCT00777023|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
490347|NCT00777101|O2|Outcome|Lapatinib+Capecitabine|"Lapatinib+Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490348|NCT00777101|O1|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490349|NCT00777101|O2|Outcome|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490350|NCT00777101|O1|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490351|NCT00777101|O2|Outcome|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490352|NCT00777101|O1|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490353|NCT00777101|O2|Outcome|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490354|NCT00777101|O1|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490355|NCT00777101|O2|Outcome|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490356|NCT00777101|O1|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490357|NCT00777101|O2|Outcome|Lapatinib+Capecitabine|"Lapatinib plus Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490358|NCT00777101|O1|Outcome|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490359|NCT00777101|E2|Reported Event|Lapatinib+Capecitabine|"Lapatinib+Capecitabine~Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.~Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity."
490360|NCT00777101|E1|Reported Event|Neratinib|"Neratinib~Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity"
490361|NCT00777062|B3|Baseline|Total|Total of all reporting groups
490362|NCT00777062|B2|Baseline|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
490363|NCT00777062|B1|Baseline|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
490364|NCT00777062|P2|Participant Flow|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
490365|NCT00777062|P1|Participant Flow|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
490366|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
490367|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
490368|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
490369|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
490370|NCT00777062|E2|Reported Event|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
490371|NCT00777062|E1|Reported Event|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
490372|NCT00777049|B3|Baseline|Total|Total of all reporting groups
490373|NCT00777049|B2|Baseline|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490374|NCT00777049|B1|Baseline|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490375|NCT00777049|P2|Participant Flow|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490376|NCT00777049|P1|Participant Flow|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490377|NCT00777049|O2|Outcome|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490378|NCT00777049|O1|Outcome|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490379|NCT00777049|E2|Reported Event|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490380|NCT00777049|E1|Reported Event|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
490381|NCT00777036|B4|Baseline|Total|Total of all reporting groups
490382|NCT00777036|B3|Baseline|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490383|NCT00777036|B2|Baseline|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490384|NCT00777036|B1|Baseline|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490385|NCT00777036|P3|Participant Flow|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490420|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490386|NCT00777036|P2|Participant Flow|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490387|NCT00777036|P1|Participant Flow|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490388|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490389|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490390|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490391|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490392|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490393|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490394|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490395|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490396|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490397|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490398|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490399|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490400|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490401|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490402|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490403|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490404|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490405|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490406|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490407|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490408|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490409|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490410|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490411|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490412|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490413|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490414|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490415|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490416|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490417|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490418|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490421|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490422|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490423|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490424|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490425|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490426|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490427|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490428|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490429|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490430|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490431|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490432|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490433|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490434|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490435|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490436|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490437|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490438|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490439|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490440|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490441|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490442|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490443|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490444|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490445|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490446|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490447|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490448|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490449|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490450|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490451|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490452|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490453|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490454|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490455|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490456|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490457|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490458|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490459|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490460|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490461|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490462|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490463|NCT00777036|O5|Outcome|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490464|NCT00777036|O4|Outcome|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490465|NCT00777036|O3|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490466|NCT00777036|O2|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490467|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490468|NCT00777036|O2|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490469|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490470|NCT00777036|O1|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490471|NCT00777036|O1|Outcome|Cohort 3|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490472|NCT00777036|O1|Outcome|Cohort 2|Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490473|NCT00777036|O1|Outcome|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490474|NCT00777036|E5|Reported Event|Cohort 2: Ph+ ALL Only|Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490475|NCT00777036|E4|Reported Event|Cohort 2: BP-CML Only|Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
490476|NCT00777036|E3|Reported Event|Cohort 1|Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490477|NCT00777036|E2|Reported Event|Cohort 3b|Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
490478|NCT00777036|E1|Reported Event|Cohort 3a|Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
490479|NCT00777023|B4|Baseline|Total|Total of all reporting groups
490480|NCT00777023|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
490481|NCT00777023|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
490482|NCT00777023|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
490483|NCT00777023|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
490484|NCT00777023|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
490485|NCT00777023|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
490486|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
490487|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
490488|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
490489|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
490490|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
490491|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
490492|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
490493|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
490494|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
490495|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
490501|NCT00776997|B1|Baseline|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
490502|NCT00776997|P1|Participant Flow|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
490503|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
490504|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
490505|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
490506|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
490507|NCT00776997|E1|Reported Event|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
490508|NCT00776984|B3|Baseline|Total|Total of all reporting groups
490509|NCT00776984|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490510|NCT00776984|B1|Baseline|Placebo|Patients treated with matching placebo
490511|NCT00776984|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490512|NCT00776984|P1|Participant Flow|Placebo|Patients treated with matching placebo
490513|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490514|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490515|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490516|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490517|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490518|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490519|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490520|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490521|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490522|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490523|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490524|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490525|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490526|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490527|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490528|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490529|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490530|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490531|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490532|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490533|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490534|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490535|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490536|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490537|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490538|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490539|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490540|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490541|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490542|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490543|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490544|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490545|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490546|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490547|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490548|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490549|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490550|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490551|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490552|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490553|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490554|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490555|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490556|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490557|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490558|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490559|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490560|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490561|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490562|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490563|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490564|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490565|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490566|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490567|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490568|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490569|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490570|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490571|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490572|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490573|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490574|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490575|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490576|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490577|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490578|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
490579|NCT00776984|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
490580|NCT00776984|E1|Reported Event|Placebo|Patients treated with matching placebo
490581|NCT00776919|B5|Baseline|Total|Total of all reporting groups
490582|NCT00776919|B4|Baseline|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490583|NCT00776919|B3|Baseline|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490584|NCT00776919|B2|Baseline|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490585|NCT00776919|B1|Baseline|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490586|NCT00776919|P4|Participant Flow|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490587|NCT00776919|P3|Participant Flow|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490588|NCT00776919|P2|Participant Flow|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490589|NCT00776919|P1|Participant Flow|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490590|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490591|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490592|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490593|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490594|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490595|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490596|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490597|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490598|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490599|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490600|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490601|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490602|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490603|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490604|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490605|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490606|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490607|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490608|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490609|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490610|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490611|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490612|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490613|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490614|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490615|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490616|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490617|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490618|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490619|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490620|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490621|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490622|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490623|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490624|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490625|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490626|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490627|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490628|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490629|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490630|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490738|NCT00776100|E2|Reported Event|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490631|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490632|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490633|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490634|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490635|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490636|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490637|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490638|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490639|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490640|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490641|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490642|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490643|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490644|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490645|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490646|NCT00776919|E4|Reported Event|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490647|NCT00776919|E3|Reported Event|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490648|NCT00776919|E2|Reported Event|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490649|NCT00776919|E1|Reported Event|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
490650|NCT00776789|B3|Baseline|Total|Total of all reporting groups
490651|NCT00776789|B2|Baseline|Control Group|baby will be kept by the mothers side and not given skin to skin contact
490652|NCT00776789|B1|Baseline|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
490653|NCT00776789|P2|Participant Flow|Control Group|baby will be kept by the mothers side and not given skin to skin contact
490654|NCT00776789|P1|Participant Flow|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
490655|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
490656|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
490657|NCT00776789|O2|Outcome|Control Group|Babies will be kept by the mothers side and not given skin to skin contact
490658|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
490659|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
490660|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
490661|NCT00776789|O2|Outcome|Control Group|Baby will be kept by the mothers side and not given skin to skin contact
490662|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
490663|NCT00776789|E2|Reported Event|Control Group|baby will be kept by the mothers side and not given skin to skin contact
490664|NCT00776789|E1|Reported Event|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
490665|NCT00776659|B1|Baseline|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490666|NCT00776659|P1|Participant Flow|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490667|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490668|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490669|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490670|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490671|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490672|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490673|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490674|NCT00776659|E1|Reported Event|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
490675|NCT00776594|B3|Baseline|Total|Total of all reporting groups
490676|NCT00776594|B2|Baseline|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
490677|NCT00776594|B1|Baseline|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
490678|NCT00776594|P2|Participant Flow|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
490679|NCT00776594|P1|Participant Flow|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
490680|NCT00776594|O2|Outcome|Leptin in Patients Treated With ADT Alone|Leptin in patients with sample available treated with ADT alone
490681|NCT00776594|O1|Outcome|Leptin Level in Patients Treated With ADT+Bev|Leptin level in patients with sample available treated with ADT+bev
490682|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
490683|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
490684|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
490685|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
490686|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
490687|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
490688|NCT00776594|E2|Reported Event|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
490689|NCT00776594|E1|Reported Event|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
490690|NCT00776555|B3|Baseline|Total|Total of all reporting groups
490691|NCT00776555|B2|Baseline|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
490692|NCT00776555|B1|Baseline|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
490739|NCT00776100|E1|Reported Event|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490693|NCT00776555|P2|Participant Flow|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
490694|NCT00776555|P1|Participant Flow|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
490695|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
490696|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
490697|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
490698|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
490699|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
490700|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
490701|NCT00776555|E2|Reported Event|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
490702|NCT00776555|E1|Reported Event|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
490703|NCT00776295|B1|Baseline|p53 Vaccination|Dendritic cell p53 vaccination
490704|NCT00776295|P1|Participant Flow|p53 Vaccination|Dendritic cell p53 vaccination
490705|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
490706|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
490707|NCT00776295|E1|Reported Event|Biological/Vaccine|Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expaned T-lymphocytes
490708|NCT00776230|B4|Baseline|Total|Total of all reporting groups
490709|NCT00776230|B3|Baseline|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
490710|NCT00776230|B2|Baseline|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
490711|NCT00776230|B1|Baseline|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
490712|NCT00776230|P3|Participant Flow|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
490713|NCT00776230|P2|Participant Flow|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
490714|NCT00776230|P1|Participant Flow|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
490715|NCT00776230|O3|Outcome|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
490716|NCT00776230|O2|Outcome|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
490717|NCT00776230|O1|Outcome|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
490718|NCT00776230|E3|Reported Event|IC51 Cohort 3|
490719|NCT00776230|E2|Reported Event|IC51 Cohort 2|
490720|NCT00776230|E1|Reported Event|IC51 Cohort 1|
490721|NCT00776100|B3|Baseline|Total|Total of all reporting groups
490722|NCT00776100|B2|Baseline|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490723|NCT00776100|B1|Baseline|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490724|NCT00776100|P2|Participant Flow|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490725|NCT00776100|P1|Participant Flow|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490726|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490727|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490728|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490729|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490730|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490731|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490732|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490733|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490734|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490735|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490736|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
490737|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
490740|NCT00776009|B7|Baseline|Total|Total of all reporting groups
490741|NCT00776009|B6|Baseline|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
490742|NCT00776009|B5|Baseline|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
490743|NCT00776009|B4|Baseline|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
490744|NCT00776009|B3|Baseline|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
490745|NCT00776009|B2|Baseline|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
490746|NCT00776009|B1|Baseline|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
490747|NCT00776009|P6|Participant Flow|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
490748|NCT00776009|P5|Participant Flow|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
490749|NCT00776009|P4|Participant Flow|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
490750|NCT00776009|P3|Participant Flow|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
490751|NCT00776009|P2|Participant Flow|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
490752|NCT00776009|P1|Participant Flow|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
490753|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
490754|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
490755|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
490756|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
490757|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
490758|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
490759|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
490760|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
490761|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
490762|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
490763|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
490764|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
490765|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
490798|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490766|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
490767|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
490768|NCT00776009|E3|Reported Event|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
490769|NCT00776009|E2|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
490770|NCT00776009|E1|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
490771|NCT00775983|B3|Baseline|Total|Total of all reporting groups
490772|NCT00775983|B2|Baseline|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
490773|NCT00775983|B1|Baseline|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
490774|NCT00775983|P2|Participant Flow|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
490775|NCT00775983|P1|Participant Flow|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
490776|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
490777|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
490778|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
490779|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
490780|NCT00775983|E2|Reported Event|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
490781|NCT00775983|E1|Reported Event|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
490782|NCT00775944|B5|Baseline|Total|Total of all reporting groups
490783|NCT00775944|B4|Baseline|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490784|NCT00775944|B3|Baseline|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490785|NCT00775944|B2|Baseline|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490786|NCT00775944|B1|Baseline|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490787|NCT00775944|P4|Participant Flow|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490788|NCT00775944|P3|Participant Flow|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490789|NCT00775944|P2|Participant Flow|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490790|NCT00775944|P1|Participant Flow|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490791|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490792|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490793|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490794|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490795|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490796|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490797|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490799|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490800|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490801|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490802|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490803|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490804|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490805|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490806|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490807|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490808|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490809|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490810|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490811|NCT00775944|E4|Reported Event|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
490812|NCT00775944|E3|Reported Event|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
490813|NCT00775944|E2|Reported Event|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
490814|NCT00775944|E1|Reported Event|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
490815|NCT00775684|B4|Baseline|Total|Total of all reporting groups
490816|NCT00775684|B3|Baseline|Glimepiride|"Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
490817|NCT00775684|B2|Baseline|Sitagliptin|"Sitagliptin (Januvia®)—100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
490818|NCT00775684|B1|Baseline|Exenatide|"Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
490819|NCT00775684|P3|Participant Flow|Glimepiride|"Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
490820|NCT00775684|P2|Participant Flow|Sitagliptin|"Sitagliptin (Januvia®)—100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
490821|NCT00775684|P1|Participant Flow|Exenatide|"Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
490822|NCT00775684|O3|Outcome|Glimepiride|"Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
490823|NCT00775684|O2|Outcome|Sitagliptin|"Sitagliptin (Januvia®)—100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
490824|NCT00775684|O1|Outcome|Exenatide|"Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
490825|NCT00775684|O3|Outcome|P50 Glimepiride|Plasma glucose level at which half-maximal insulin secretion is achieved during the glucose-potentiated arginine test
490826|NCT00775684|O2|Outcome|P50 Sitagliptin|Plasma glucose level at which half-maximal insulin secretion is achieved during the glucose-potentiated arginine test
490827|NCT00775684|O1|Outcome|P50 Exenatide|Plasma glucose level at which half-maximal insulin secretion is achieved during the glucose-potentiated arginine test
490828|NCT00775684|O3|Outcome|M/I Glimepiride|Change in insulin sensitivity
490829|NCT00775684|O2|Outcome|M/I Sitagliptin|Change in insulin sensitivity
490830|NCT00775684|O1|Outcome|M/I Exenatide|Change in insulin sensitivity
490831|NCT00775684|O3|Outcome|AIRarg Glimepiride|Acute insulin response to arginine
490832|NCT00775684|O2|Outcome|AIRarg Sitagliptin|Acute insulin response to arginine
490833|NCT00775684|O1|Outcome|AIRarg Exenatide|Acute insulin response to arginine
490834|NCT00775684|O3|Outcome|Glimepiride|"Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
490835|NCT00775684|O2|Outcome|Sitagliptin|"Sitagliptin (Januvia®)—100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
490886|NCT00775606|P2|Participant Flow|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
491100|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
490836|NCT00775684|O1|Outcome|Exenatide|"Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
490837|NCT00775684|E3|Reported Event|Glimepiride|"Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl~Glimepiride: Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl"
490838|NCT00775684|E2|Reported Event|Sitagliptin|"Sitagliptin (Januvia®)—100 mg by mouth every morning~Sitagliptin: Sitagliptin (Januvia®)100 mg by mouth every morning"
490839|NCT00775684|E1|Reported Event|Exenatide|"Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects~Exenatide: Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects"
490840|NCT00775671|B3|Baseline|Total|Total of all reporting groups
490841|NCT00775671|B2|Baseline|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
490842|NCT00775671|B1|Baseline|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
490843|NCT00775671|P2|Participant Flow|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
490844|NCT00775671|P1|Participant Flow|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
490845|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
490846|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
490847|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
490848|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
490849|NCT00775671|E2|Reported Event|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
490850|NCT00775671|E1|Reported Event|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
490851|NCT00775658|B1|Baseline|All Participants|Includes both groups of participants
490852|NCT00775658|P2|Participant Flow|Placebo Then Olopatadine|participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
490853|NCT00775658|P1|Participant Flow|Olopatadine Then Placebo|participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
490854|NCT00775658|O2|Outcome|Placebo|
490855|NCT00775658|O1|Outcome|Olopatadine|double blind crossover
490856|NCT00775658|O2|Outcome|Placebo|
490857|NCT00775658|O1|Outcome|Olopatadine|double blind crossover
490858|NCT00775658|E2|Reported Event|Placebo|
490859|NCT00775658|E1|Reported Event|Olopatadine|double blind crossover
490860|NCT00775645|B3|Baseline|Total|Total of all reporting groups
490861|NCT00775645|B2|Baseline|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490862|NCT00775645|B1|Baseline|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490863|NCT00775645|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490864|NCT00775645|P1|Participant Flow|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490865|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490866|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490867|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490868|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490869|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490870|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490871|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490872|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490873|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490874|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490875|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490876|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490877|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490878|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490879|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490880|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490881|NCT00775645|E2|Reported Event|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
490882|NCT00775645|E1|Reported Event|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
490883|NCT00775606|B3|Baseline|Total|Total of all reporting groups
490884|NCT00775606|B2|Baseline|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
490885|NCT00775606|B1|Baseline|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
490932|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490887|NCT00775606|P1|Participant Flow|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
490888|NCT00775606|O2|Outcome|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
490889|NCT00775606|O1|Outcome|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
490890|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
490891|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
490892|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
490893|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
490894|NCT00775606|E2|Reported Event|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
490895|NCT00775606|E1|Reported Event|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
490896|NCT00775593|B1|Baseline|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
490897|NCT00775593|P1|Participant Flow|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
490898|NCT00775593|O1|Outcome|Study Group|Evaluable patients
490899|NCT00775593|O1|Outcome|Study Group|Evaluable patients
490900|NCT00775593|O1|Outcome|Study Group|Evaluable patients
490901|NCT00775593|O1|Outcome|Study Group|Evaluable patients
490902|NCT00775593|E1|Reported Event|Study Group|Evaluable patients
490903|NCT00775528|B1|Baseline|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
490904|NCT00775528|P1|Participant Flow|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
490905|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
490906|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
490907|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
490908|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
490909|NCT00775528|E1|Reported Event|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
490910|NCT00775463|B3|Baseline|Total|Total of all reporting groups
490911|NCT00775463|B2|Baseline|Treprostinil Diethanolamine|intent to treat population
490912|NCT00775463|B1|Baseline|Placebo|intent to treat population
490913|NCT00775463|P2|Participant Flow|Treprostinil Diethanolamine|All subejcts who recieved at least one dose of study drug. One subject in the treprostinil diethanolamine treatment group was randomized, withdrew consent and exited the study prior to taking any study medication and is not included in the analysis summary.
490914|NCT00775463|P1|Participant Flow|Placebo|All subjects who recieved at least one dose of study drug.
490915|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490916|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490917|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490918|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490919|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490920|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490921|NCT00775463|O6|Outcome|Treprostinil Diethanolamine- Overall Disease Status Response|Treprostinil diethanolamine intent to treat population
490922|NCT00775463|O5|Outcome|Placebo- Overall Disease Status Response|Placebo intent to treat population
490923|NCT00775463|O4|Outcome|Treprostinil Diethanolamine- Raynaud's Phenomenon Response|Treprostinil diethanolamine intent to treat population
490924|NCT00775463|O3|Outcome|Placebo- Raynaud's Phenomenon Response|Placebo intent to treat population
490925|NCT00775463|O2|Outcome|Treprostinil Diethanolamine- Digital Ulcer Response|Treprostinil diethanolamine intent to treat population
490926|NCT00775463|O1|Outcome|Placebo- Digital Ulcer Response|Placebo intent to treat population
490927|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490928|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490929|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490930|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490931|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490933|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490934|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490935|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490936|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490937|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490938|NCT00775463|O1|Outcome|Placebo|placebo intent to treat population
490939|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490940|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490941|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
490942|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
490943|NCT00775463|E2|Reported Event|Treprostinil Diethanolamine|
490944|NCT00775463|E1|Reported Event|Placebo|
490945|NCT00775450|B6|Baseline|Total|Total of all reporting groups
490946|NCT00775450|B5|Baseline|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
490947|NCT00775450|B4|Baseline|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
490948|NCT00775450|B3|Baseline|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
490949|NCT00775450|B2|Baseline|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
490950|NCT00775450|B1|Baseline|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
490951|NCT00775450|P5|Participant Flow|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
490952|NCT00775450|P4|Participant Flow|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
490953|NCT00775450|P3|Participant Flow|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
490954|NCT00775450|P2|Participant Flow|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
490955|NCT00775450|P1|Participant Flow|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
490956|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
490957|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
490958|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
490959|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
490960|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
490961|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
490962|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
490963|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
490964|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
490965|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
490966|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
490967|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
490968|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
490969|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
490970|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
490971|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
490972|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
497296|NCT00762788|E2|Reported Event|Lotrafilcon A Contact Lens|NIGHT&DAY
490973|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
490974|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
490975|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
490976|NCT00775450|E5|Reported Event|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
490977|NCT00775450|E4|Reported Event|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
490978|NCT00775450|E3|Reported Event|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
490979|NCT00775450|E2|Reported Event|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
490980|NCT00775450|E1|Reported Event|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
490981|NCT00775437|B1|Baseline|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490982|NCT00775437|P1|Participant Flow|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490983|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490984|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490985|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490986|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490987|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490988|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490989|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490990|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491035|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
491101|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491102|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
490991|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490992|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490993|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490994|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490995|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490996|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490997|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490998|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
490999|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491000|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491001|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491002|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491003|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491004|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491069|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
497660|NCT00762424|P2|Participant Flow|Placebo|placebo: cornstarch
491005|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491006|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491007|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491008|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491009|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491010|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491011|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491012|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491013|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491014|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491015|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491016|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491017|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491018|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491096|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
491097|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491019|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491020|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491021|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491022|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491023|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491024|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491025|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491026|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491027|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491028|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491029|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491030|NCT00775437|E1|Reported Event|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
491031|NCT00775411|B1|Baseline|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
491032|NCT00775411|P1|Participant Flow|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
491033|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
491034|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
491098|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
491099|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491036|NCT00775411|E1|Reported Event|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
491037|NCT00775346|B1|Baseline|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
491038|NCT00775346|P1|Participant Flow|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
491039|NCT00775346|O1|Outcome|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
491040|NCT00775346|E1|Reported Event|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
491041|NCT00775229|B3|Baseline|Total|Total of all reporting groups
491042|NCT00775229|B2|Baseline|Placebo|"Placebo~Placebo : pill, by mouth, daily"
491043|NCT00775229|B1|Baseline|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
491044|NCT00775229|P2|Participant Flow|Placebo|"Placebo~Placebo : pill, by mouth, daily"
491045|NCT00775229|P1|Participant Flow|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
491046|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
491047|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
491048|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
491049|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
491050|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
491051|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
491052|NCT00775229|E2|Reported Event|Placebo|"Placebo~Placebo : pill, by mouth, daily"
491053|NCT00775229|E1|Reported Event|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
491054|NCT00775203|B3|Baseline|Total|Total of all reporting groups
491055|NCT00775203|B2|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491056|NCT00775203|B1|Baseline|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491057|NCT00775203|P2|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491058|NCT00775203|P1|Participant Flow|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491059|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491060|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491061|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491062|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491063|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491064|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491065|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491066|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491067|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491068|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491070|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491071|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491072|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491073|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491074|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491075|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491076|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491077|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491078|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491079|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491080|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491081|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491082|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491083|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491084|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491085|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491086|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491087|NCT00775203|E2|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
491088|NCT00775203|E1|Reported Event|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
491089|NCT00775190|B3|Baseline|Total|Total of all reporting groups
491090|NCT00775190|B2|Baseline|Trinessa™|Trinessa: generic oral contraceptive
491091|NCT00775190|B1|Baseline|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491092|NCT00775190|P2|Participant Flow|Trinessa™|Trinessa: generic oral contraceptive
491093|NCT00775190|P1|Participant Flow|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491094|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
491095|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491103|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491104|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
491105|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491106|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
491107|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491108|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
491109|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491110|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
491111|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491112|NCT00775190|E2|Reported Event|Trinessa™|Trinessa: generic oral contraceptive
491113|NCT00775190|E1|Reported Event|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
491114|NCT00775021|B1|Baseline|Total Participants|Total number of participants that completed the study.
491115|NCT00775021|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A contact lens worn first and etafilcon A contact lens second.
491116|NCT00775021|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A contact lens worn first and nelfilcon A contact lens worn second
491117|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
491118|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
491119|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
491120|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
491121|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
491122|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
491123|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
491124|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
491125|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
491126|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
491127|NCT00775021|E2|Reported Event|Nelfilcon A|nelfilcon A contact lenses.
491128|NCT00775021|E1|Reported Event|Etafilcon A|etafilcon A contact lenses
491129|NCT00774995|B5|Baseline|Total|Total of all reporting groups
491130|NCT00774995|B4|Baseline|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491131|NCT00774995|B3|Baseline|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491132|NCT00774995|B2|Baseline|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491133|NCT00774995|B1|Baseline|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491134|NCT00774995|P4|Participant Flow|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491135|NCT00774995|P3|Participant Flow|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491136|NCT00774995|P2|Participant Flow|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491137|NCT00774995|P1|Participant Flow|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491138|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491139|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491140|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491141|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491142|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491143|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491144|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
492343|NCT00773253|O2|Outcome|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
491145|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491146|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491147|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491148|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491149|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491150|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491151|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491152|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491153|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491154|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491155|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491156|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491157|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491158|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491159|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491160|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491161|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491162|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491163|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491164|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491165|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491166|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491167|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491168|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491169|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491170|NCT00774995|E4|Reported Event|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491171|NCT00774995|E3|Reported Event|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
492344|NCT00773253|O1|Outcome|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
491172|NCT00774995|E2|Reported Event|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491173|NCT00774995|E1|Reported Event|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
491174|NCT00774930|B3|Baseline|Total|Total of all reporting groups
491175|NCT00774930|B2|Baseline|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
491176|NCT00774930|B1|Baseline|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
491177|NCT00774930|P2|Participant Flow|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
491178|NCT00774930|P1|Participant Flow|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.
491179|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491180|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491181|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491182|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491183|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491184|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491185|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491186|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491187|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491188|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491189|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491190|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491191|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491192|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491193|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491194|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491195|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491196|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491197|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
491198|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
491199|NCT00774930|E4|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)|All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
491200|NCT00774930|E3|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)|All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
491201|NCT00774930|E2|Reported Event|Placebo (DB Phase)|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
491202|NCT00774930|E1|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
491203|NCT00774852|B3|Baseline|Total|Total of all reporting groups
491286|NCT00774748|O1|Outcome|Once Daily Dosing|10 participants were placed on an once daily dosing schedule in accordance with their physician approved, standard of care weight specific dosage.
491287|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily.
491204|NCT00774852|B2|Baseline|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491205|NCT00774852|B1|Baseline|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491206|NCT00774852|P2|Participant Flow|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491207|NCT00774852|P1|Participant Flow|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491208|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
491209|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
491210|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
491211|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
491212|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
491213|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
491214|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491215|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491288|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily LMWH.
491289|NCT00774748|O1|Outcome|All Participants|Both dosing schedules, once and twice daily, all participants.
491216|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491217|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491218|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491219|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491220|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491221|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491222|NCT00774852|O6|Outcome|Week 24 No Response: Placebo|At Week 28 participants assigned to Placebo group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
491223|NCT00774852|O5|Outcome|Week 24 No Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
491224|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
491225|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
491226|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
491227|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
491596|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491228|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491229|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491230|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491231|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491232|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491233|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491234|NCT00774852|O2|Outcome|Week 24 Non-Responder Who Continued Treatment: Placebo|Participants who were in the placebo arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
491235|NCT00774852|O1|Outcome|Week 24 Non-Responder Who Continued Treatment: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
491236|NCT00774852|O2|Outcome|Week 24 Non-Responder: Placebo|Participants who were in the placebo arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
491237|NCT00774852|O1|Outcome|Week 24 Non-Responder: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
491261|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
491262|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
497880|NCT00762229|E2|Reported Event|Ezetimibe 5 mg|Ezetimibe 5 mg,
491238|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491239|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491240|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491241|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491242|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
491243|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
491244|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
491245|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
491246|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
491247|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
491248|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491249|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491284|NCT00774748|P1|Participant Flow|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
491250|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491251|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491252|NCT00774852|E2|Reported Event|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
491253|NCT00774852|E1|Reported Event|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
491254|NCT00774800|B1|Baseline|Overall Study|"Humalog+recombinant human hyaluronidase PH20 (rHuPH20): Up to 3 dose-finding (DF) visits (each visit separated by 3-10 days [d]) until an appropriate dose of Humalog was identified. For each DF visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously (SC) per unit of Humalog, corresponding to a mass concentration (conc) of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final conc of 91 U/mL of Humalog)~Humalog alone: After a 3-10 d washout (wo), a single SC injection of the appropriate identified dose of Humalog was delivered~Humulin-R+rHuPH20: After a 3-10 d wo, up to 2 DF visits (both visits separated by 3-10 d) until an appropriate dose of Humulin-R was identified. For each DF visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a mass conc of 20.0 μg/mL rHuPH20 (at final conc of 100 U/mL of Humulin-R)~Humulin-R alone: After a 3-10 d wo, a single SC injection of the appropriate identified dose of Humulin-R was delivered"
491255|NCT00774800|P1|Participant Flow|First Humalog+PH20, Then Humalog, Humulin-R+PH20, Humulin-R|"Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.~Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.~Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.~Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.~Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was <160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.~All dose finding visits and interventions were separated by 3-10 days."
491256|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
491257|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
491258|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
491259|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
491260|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
491285|NCT00774748|O1|Outcome|All Participants|All participants on both a daily and twice daily dosing schedule
499039|NCT00759863|B3|Baseline|Total|Total of all reporting groups
491263|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
491264|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
491265|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
491266|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
491267|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
491268|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
491269|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
491270|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
491271|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
491272|NCT00774800|E4|Reported Event|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
491273|NCT00774800|E3|Reported Event|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
491274|NCT00774800|E2|Reported Event|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
491275|NCT00774800|E1|Reported Event|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
491276|NCT00774787|B1|Baseline|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
491277|NCT00774787|P1|Participant Flow|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
491278|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
491279|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
491280|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
491281|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
491282|NCT00774787|E1|Reported Event|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
491283|NCT00774748|B1|Baseline|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
491290|NCT00774748|E1|Reported Event|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
491291|NCT00774397|B8|Baseline|Total|Total of all reporting groups
491292|NCT00774397|B7|Baseline|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491293|NCT00774397|B6|Baseline|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491294|NCT00774397|B5|Baseline|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491295|NCT00774397|B4|Baseline|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491296|NCT00774397|B3|Baseline|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491297|NCT00774397|B2|Baseline|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491298|NCT00774397|B1|Baseline|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491299|NCT00774397|P7|Participant Flow|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491300|NCT00774397|P6|Participant Flow|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491301|NCT00774397|P5|Participant Flow|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491302|NCT00774397|P4|Participant Flow|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491303|NCT00774397|P3|Participant Flow|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491304|NCT00774397|P2|Participant Flow|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491305|NCT00774397|P1|Participant Flow|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491306|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491307|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491308|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491309|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491310|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
492345|NCT00773253|E2|Reported Event|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
491311|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491312|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491313|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491314|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491315|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491316|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491317|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491318|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491319|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491320|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491321|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491322|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491323|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491324|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491325|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491326|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491327|NCT00774397|O6|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491328|NCT00774397|O5|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491329|NCT00774397|O4|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491330|NCT00774397|O3|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491331|NCT00774397|O2|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491332|NCT00774397|O1|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491333|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491334|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491335|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491336|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491337|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491338|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491339|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491340|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491341|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491342|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491343|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491344|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491345|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491346|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491347|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491348|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491349|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491350|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491351|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491597|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491352|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491353|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491354|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491355|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491356|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491357|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491358|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491359|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491360|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491361|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491362|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491363|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491364|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491365|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491366|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491367|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491368|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491369|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491370|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491371|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491372|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491373|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491374|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491375|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491376|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491377|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491378|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491379|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491380|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491381|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491382|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491383|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491384|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491385|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491386|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491387|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491388|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491389|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491390|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491391|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491392|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491393|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491394|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491395|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491396|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491397|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491398|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491399|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491400|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491401|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491402|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491403|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491404|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491405|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491406|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491407|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491408|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491409|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491410|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491411|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491412|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491413|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491414|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491415|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491416|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491417|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491418|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491419|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491420|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491421|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491422|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491423|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491424|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491425|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491426|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491427|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491428|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491429|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491430|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491431|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491432|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491433|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491434|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491435|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491436|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491437|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491438|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491439|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491440|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491441|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491442|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491443|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491444|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491445|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491446|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491447|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491448|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491449|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491450|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491451|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491452|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491453|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491454|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491455|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491456|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491457|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491458|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491459|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491460|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491461|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491462|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491463|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491464|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491465|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491466|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491467|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491468|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491469|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491470|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491471|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491472|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491473|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491474|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491475|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491476|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491477|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491478|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491479|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491480|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491481|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491482|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491483|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491484|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491485|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491486|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491487|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491488|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491489|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491490|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491491|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491492|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491493|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491494|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491495|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491496|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491497|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491498|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491499|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491500|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491501|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491502|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491503|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491504|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491505|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491506|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491507|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491508|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491509|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491510|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491511|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491512|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491513|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491514|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491515|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491516|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491517|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491518|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491519|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491520|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491521|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491522|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491523|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491524|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491525|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491526|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491527|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491528|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491529|NCT00774397|E7|Reported Event|240mg BID/LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491530|NCT00774397|E6|Reported Event|240mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491531|NCT00774397|E5|Reported Event|240mg QD/LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491532|NCT00774397|E4|Reported Event|240mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491533|NCT00774397|E3|Reported Event|240mg QD/LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491534|NCT00774397|E2|Reported Event|120mg QD/LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491535|NCT00774397|E1|Reported Event|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
491536|NCT00774306|B5|Baseline|Total|Total of all reporting groups
491537|NCT00774306|B4|Baseline|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
491538|NCT00774306|B3|Baseline|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
491539|NCT00774306|B2|Baseline|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
491540|NCT00774306|B1|Baseline|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses."
491541|NCT00774306|P4|Participant Flow|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
491542|NCT00774306|P3|Participant Flow|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
491598|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491543|NCT00774306|P2|Participant Flow|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
491544|NCT00774306|P1|Participant Flow|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.~x~x"
491545|NCT00774306|O4|Outcome|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
491546|NCT00774306|O3|Outcome|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
491547|NCT00774306|O2|Outcome|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
491548|NCT00774306|O1|Outcome|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
491549|NCT00774306|E4|Reported Event|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
491550|NCT00774306|E3|Reported Event|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
491551|NCT00774306|E2|Reported Event|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
491552|NCT00774306|E1|Reported Event|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
491553|NCT00774267|B5|Baseline|Total|Total of all reporting groups
491554|NCT00774267|B4|Baseline|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491555|NCT00774267|B3|Baseline|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491556|NCT00774267|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491557|NCT00774267|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491558|NCT00774267|P4|Participant Flow|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491559|NCT00774267|P3|Participant Flow|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491560|NCT00774267|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491561|NCT00774267|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491562|NCT00774267|O4|Outcome|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491563|NCT00774267|O3|Outcome|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491564|NCT00774267|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
492346|NCT00773253|E1|Reported Event|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
491565|NCT00774267|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491566|NCT00774267|E4|Reported Event|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491567|NCT00774267|E3|Reported Event|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491568|NCT00774267|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491569|NCT00774267|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
491570|NCT00774163|B3|Baseline|Total|Total of all reporting groups
491571|NCT00774163|B2|Baseline|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491572|NCT00774163|B1|Baseline|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491573|NCT00774163|P2|Participant Flow|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491574|NCT00774163|P1|Participant Flow|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491575|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491576|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491577|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491578|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491579|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491580|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491581|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491582|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491583|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491584|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491585|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491586|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491587|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491588|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491589|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491590|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491591|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491592|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491593|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491594|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491595|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
492380|NCT00772954|B4|Baseline|Total|Total of all reporting groups
491599|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491600|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491601|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491602|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491603|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491604|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491605|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491606|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491607|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491608|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491609|NCT00774163|E2|Reported Event|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
491610|NCT00774163|E1|Reported Event|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
491611|NCT00774046|B1|Baseline|All Patients|Ara-C Mitoxantrone Etoposide
491612|NCT00774046|P1|Participant Flow|Induction Chemotherapy Followed by Stem Cell Transplant|Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
491613|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
491614|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
491615|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
491616|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
491617|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
491618|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
491619|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
491620|NCT00774046|E1|Reported Event|All Patients|Ara-C Mitoxantrone Etoposide
491621|NCT00773968|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
491622|NCT00773968|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator [CERA]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (<) 40 µg or 40-80 µg or greater than (>) 80 µg, respectively. The doses were adjusted according to individual participant’s hemoglobin (Hb) value.
491623|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
491624|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
491625|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
491626|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
491627|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
491628|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
492556|NCT00772590|P1|Participant Flow|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
491629|NCT00773968|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
491630|NCT00773955|B1|Baseline|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
491631|NCT00773955|P1|Participant Flow|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
491632|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
491633|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
491634|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
491635|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
491636|NCT00773955|E1|Reported Event|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
491637|NCT00773786|B1|Baseline|All Study Participants|Participants randomized and received either Tiotropium + Brovana twice daily for 1 week or Tiotropium + placebo twice daily for 1 week.
491638|NCT00773786|P2|Participant Flow|Placebo, Then Arformoterol (Brovana)|Participants first received Tiotropium + Placebo twice daily for 1 week . After a 1 week washout period, they received Tiotropium + Brovana twice daily for 1 week via nebulizer.
491639|NCT00773786|P1|Participant Flow|Tiotropium + Arformoterol (Brovana), Then Tiotropium + Placebo|Participants first received Tiotropium + Brovana twice daily for 1 week via nebulizer. After a 1 week washout period, they received Tiotropium + placebo twice daily for 1 week.
491640|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week
491641|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
491642|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
491643|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
491644|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
491645|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
491646|NCT00773786|E2|Reported Event|Placebo|Placebo twice daily for 1 week
491647|NCT00773786|E1|Reported Event|Arformoterol|Arformoterol twice daily for 1 week via nebulizer
491648|NCT00773734|B5|Baseline|Total|Total of all reporting groups
491649|NCT00773734|B4|Baseline|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491650|NCT00773734|B3|Baseline|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491651|NCT00773734|B2|Baseline|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
491652|NCT00773734|B1|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
491653|NCT00773734|P6|Participant Flow|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491654|NCT00773734|P5|Participant Flow|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491655|NCT00773734|P4|Participant Flow|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491656|NCT00773734|P3|Participant Flow|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491657|NCT00773734|P2|Participant Flow|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).
491658|NCT00773734|P1|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
492557|NCT00772590|O4|Outcome|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
491659|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491660|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491661|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491662|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491663|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491664|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491665|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491666|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491667|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491668|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491669|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491670|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491671|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491672|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491673|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491674|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491675|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491676|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491677|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491678|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491679|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491680|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491681|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491682|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491683|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491684|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491685|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491686|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491687|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491688|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491689|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491690|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491691|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491692|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491693|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491694|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491803|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492558|NCT00772590|O3|Outcome|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
491695|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491696|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491697|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491698|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491699|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491700|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491701|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491702|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491703|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491704|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491705|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491706|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491707|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491708|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491709|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491890|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
492223|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
491710|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491711|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491712|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491713|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491714|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491715|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491716|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491717|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491718|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491719|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491720|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491721|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491722|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491723|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491724|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492110|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
492111|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491725|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491726|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491727|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491728|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491729|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491730|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491731|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491732|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491733|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491734|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491735|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491736|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491737|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491738|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491739|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492112|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492113|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492630|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
491740|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491741|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491742|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491743|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491744|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491745|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491746|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491747|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491748|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491749|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491750|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491751|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491752|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491753|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491754|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491755|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491756|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491757|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491758|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491759|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491760|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491761|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491762|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491763|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491764|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491765|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491766|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491767|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491768|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491769|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491770|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491771|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491772|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491773|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491774|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491775|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491776|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491777|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491778|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492114|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
491779|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491780|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491781|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491782|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491783|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491784|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491785|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
491786|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491787|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
491788|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491789|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491790|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
491791|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491792|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
491793|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491794|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491795|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
491796|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491797|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
491798|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
491799|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491800|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
491801|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491802|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
491804|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491805|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491806|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491807|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491808|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491809|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491810|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491811|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491812|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491813|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491814|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491815|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491816|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491817|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491818|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491819|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492115|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
491820|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491821|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491822|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491823|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491824|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491825|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491826|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491827|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491828|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491829|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491830|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491831|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491832|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491833|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491834|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492116|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492117|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
499566|NCT00758758|O5|Outcome|Plated Autograft|Plated Autograft
491835|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491836|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491837|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491838|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491839|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491840|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491841|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491842|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491843|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491844|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491845|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491846|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491847|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491848|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491849|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492118|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492119|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492631|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
491850|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491851|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491852|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491853|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491854|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491855|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491856|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491857|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491858|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491859|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491860|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491861|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491862|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491863|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491864|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492120|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492121|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492122|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
491865|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491866|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491867|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491868|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491869|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491870|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491871|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
491872|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491873|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491874|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
491875|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
491876|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491877|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491878|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
491879|NCT00773734|O1|Outcome|Placebo BID|.Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
491880|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491881|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491882|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
491883|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16)
491884|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491885|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491886|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
491887|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491888|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491889|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
491891|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491892|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491893|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491894|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491895|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491896|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491897|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491898|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491899|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491900|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491901|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491902|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491903|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491904|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491905|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492123|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492124|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
499729|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
491906|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491907|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491908|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491909|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491910|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491911|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491912|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491913|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491914|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491915|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491916|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491917|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491918|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491919|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491920|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492125|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492126|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492262|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492559|NCT00772590|O2|Outcome|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
491921|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491922|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491923|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491924|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491925|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491926|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491927|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491928|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491929|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491930|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491931|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491932|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491933|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491934|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491935|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492150|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492151|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
504231|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
491936|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491937|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491938|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491939|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491940|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491941|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491942|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491943|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491944|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491945|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491946|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491947|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491948|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491949|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491950|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492152|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16).
492153|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492263|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492632|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
491951|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491952|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491953|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491954|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491955|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491956|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491957|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491958|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491959|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491960|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491961|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491962|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491963|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491964|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491965|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492181|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492182|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
504232|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
491966|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491967|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491968|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491969|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491970|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491971|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491972|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491973|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491974|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491975|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491976|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491977|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491978|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491979|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491980|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492183|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492184|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492264|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492560|NCT00772590|O1|Outcome|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
491981|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491982|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491983|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491984|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491985|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491986|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491987|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491988|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491989|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491990|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
491991|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491992|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491993|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491994|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
491995|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492210|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492211|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492212|NCT00773734|E7|Reported Event|Apremilast 30mg BID (APR Exposure Period) Years 0-6|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
491996|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491997|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
491998|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
491999|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492000|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492001|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492002|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492003|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492004|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492005|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492006|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492007|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492008|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492009|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492010|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492213|NCT00773734|E6|Reported Event|Apremilast 20mg BID (APR Exposure Period) Years 0-6|Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
492214|NCT00773734|E5|Reported Event|Apremilast 10mg BID (APR Exposure Period) Years 0-6|Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).
492011|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492012|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492013|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492014|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492015|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492016|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492017|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492018|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492019|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492020|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492021|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492022|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492023|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492024|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492025|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492215|NCT00773734|E4|Reported Event|Apremilast 30mg BID (Weeks 0-16)|Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
492216|NCT00773734|E3|Reported Event|Apremilast 20mg BID (Weeks 0-16)|Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
492217|NCT00773734|E2|Reported Event|Apremilast 10mg BID (Weeks 0-16)|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492561|NCT00772590|E4|Reported Event|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
492026|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492027|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492028|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492029|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492030|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492031|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492032|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492033|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492034|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492035|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492036|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492037|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492038|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492039|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492040|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492218|NCT00773734|E1|Reported Event|Placebo (Weeks 0-16)|Participants randomized to placebo PO BID during the Placebo-controlled Phase
492219|NCT00773474|B1|Baseline|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
504233|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
492041|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492042|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492043|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492044|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492045|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492046|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492047|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492048|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492049|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492050|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492051|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492052|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492053|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492054|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492055|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492220|NCT00773474|P1|Participant Flow|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
492265|NCT00773461|E2|Reported Event|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492056|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492057|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492058|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492059|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492060|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492061|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492062|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492063|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492064|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492065|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492066|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492067|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492068|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492069|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492070|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492221|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
492266|NCT00773461|E1|Reported Event|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492071|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492072|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492073|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492074|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492075|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492076|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492077|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492078|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492079|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492080|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492081|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492082|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492083|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492084|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492085|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492222|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
492267|NCT00773422|B4|Baseline|Total|Total of all reporting groups
492268|NCT00773422|B3|Baseline|Placebo|"placebo control~placebo: placebo"
492086|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492087|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492088|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492089|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492090|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
492091|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492092|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492093|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492094|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492095|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492096|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492097|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492098|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492099|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492100|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492101|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492102|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492103|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
492104|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
492105|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492106|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492107|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492108|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492109|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
492296|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492127|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492128|NCT00773734|O4|Outcome|Placebo-Apremilast (APR) 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
492129|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492130|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492131|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492132|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492133|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492134|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492135|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492136|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492137|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
492138|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492139|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492140|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492141|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492142|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492143|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492144|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492145|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492146|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
492147|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492148|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492149|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492154|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492155|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
492156|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492157|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492158|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492159|NCT00773734|O4|Outcome|Apremilast 30 mg|Participants were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492160|NCT00773734|O3|Outcome|Apremilast 20mg|Participants were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492161|NCT00773734|O2|Outcome|Apremilast 10mg|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492162|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492163|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
492164|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
492165|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492166|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492167|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492168|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492169|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492170|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492171|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16). .
492172|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492173|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492174|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492175|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
492176|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
492177|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg tablets BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
492178|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492179|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492180|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to APR 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
504234|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
492185|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492186|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
492187|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
492188|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
492189|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492190|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492191|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492192|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492193|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
492194|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
492195|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
492196|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492197|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
492198|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
492199|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492200|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492201|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
492202|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16).
492203|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
492204|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg PO BID during the active treatment phase (Weeks 16-24).
492205|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492206|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492207|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 10 mg BID PO during the Active Treatment Phase (Weeks 16-24).
492208|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
492209|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
492224|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
492225|NCT00773474|E1|Reported Event|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
492226|NCT00773461|B3|Baseline|Total|Total of all reporting groups
492227|NCT00773461|B2|Baseline|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492228|NCT00773461|B1|Baseline|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492229|NCT00773461|P2|Participant Flow|Tocilizumab + DMARDs|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
492230|NCT00773461|P1|Participant Flow|Placebo + DMARDs|Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
492231|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492232|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492233|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492234|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492235|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492236|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492237|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492238|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492239|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492240|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492241|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492242|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492243|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492244|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492245|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492246|NCT00773461|O1|Outcome|Placebo+DMARD|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492247|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492248|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492249|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492250|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492251|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492252|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492253|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492254|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492255|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492256|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492257|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492258|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492259|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492260|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
492261|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
504235|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
492269|NCT00773422|B2|Baseline|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492270|NCT00773422|B1|Baseline|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492271|NCT00773422|P3|Participant Flow|Placebo|"placebo control~placebo: placebo"
492272|NCT00773422|P2|Participant Flow|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492273|NCT00773422|P1|Participant Flow|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492274|NCT00773422|O3|Outcome|Placebo|"placebo control~placebo: placebo"
492275|NCT00773422|O2|Outcome|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492276|NCT00773422|O1|Outcome|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492277|NCT00773422|O3|Outcome|Placebo|"placebo control~placebo: placebo"
492278|NCT00773422|O2|Outcome|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492279|NCT00773422|O1|Outcome|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492280|NCT00773422|E3|Reported Event|Placebo|"placebo control~placebo: placebo"
492281|NCT00773422|E2|Reported Event|Varenicline|"varenicline 2mg~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492282|NCT00773422|E1|Reported Event|Naltrexone + Varenicline|"naltrexone (25mg) + varenicline (2mg)~naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).~varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8)."
492283|NCT00773383|B1|Baseline|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492284|NCT00773383|P1|Participant Flow|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492285|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492286|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492287|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492288|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492289|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492290|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492291|NCT00773383|O4|Outcome|R1507_Baseline Missing|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
492292|NCT00773383|O3|Outcome|R1507_Baseline Diabetes Mellitus|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL"
492293|NCT00773383|O2|Outcome|R1507_Baseline Impaired Fasting Glucose|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 110 to < 126 mg/dL"
492294|NCT00773383|O1|Outcome|R1507_Baseline Glucose Normal|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline < 110 mg/dL."
492295|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
504236|NCT00746733|O2|Outcome|Adderall XR|
492297|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492298|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492299|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492300|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492301|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492302|NCT00773383|E1|Reported Event|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
492303|NCT00773370|B3|Baseline|Total|Total of all reporting groups
492304|NCT00773370|B2|Baseline|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
492305|NCT00773370|B1|Baseline|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
492306|NCT00773370|P2|Participant Flow|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
492307|NCT00773370|P1|Participant Flow|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
492308|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
492309|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
492310|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
492311|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
492312|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
492313|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
504237|NCT00746733|O1|Outcome|Vyvanse|
492314|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
492315|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
492316|NCT00773370|E2|Reported Event|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
492317|NCT00773370|E1|Reported Event|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
492318|NCT00773279|B1|Baseline|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
492319|NCT00773279|P2|Participant Flow|FlexPen® -> PDS290|
492320|NCT00773279|P1|Participant Flow|PDS290 -> FlexPen®|
492321|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492322|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492323|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492324|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492325|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492326|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492327|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492328|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492329|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492330|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492331|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492332|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492333|NCT00773279|O1|Outcome|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
492334|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492335|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492336|NCT00773279|E2|Reported Event|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
492337|NCT00773279|E1|Reported Event|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
492338|NCT00773253|B3|Baseline|Total|Total of all reporting groups
492339|NCT00773253|B2|Baseline|Multi-channel EMG-guided Botox Injection Then Single Channel|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.
492340|NCT00773253|B1|Baseline|Standard EMG Guided Injections Then Multi-channel|All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
492341|NCT00773253|P2|Participant Flow|Multi-channel EMG-guided Botox Injection Then Standard EMG Inj|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
492342|NCT00773253|P1|Participant Flow|Standard EMG Guided Injections Then Multi-channel Injections|All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
492562|NCT00772590|E3|Reported Event|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
492347|NCT00773136|B1|Baseline|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
492348|NCT00773136|P1|Participant Flow|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
492349|NCT00773136|O2|Outcome|Control Group|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
492350|NCT00773136|O1|Outcome|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
492351|NCT00773136|E1|Reported Event|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
492352|NCT00773097|B1|Baseline|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
492353|NCT00773097|P1|Participant Flow|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
492354|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
492355|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
492356|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
492357|NCT00773097|E1|Reported Event|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
492358|NCT00772967|B1|Baseline|All Participants|All randomized participants
492359|NCT00772967|P6|Participant Flow|Ultracet, Naproxen, Placebo|Ultracet in Treatment Period 1, Naproxen in Treatment Period 2, Placebo in Treatment Period 3.
492360|NCT00772967|P5|Participant Flow|Naproxen, Placebo, Ultracet|Naproxen in Treatment Period 1, Placebo in Treatment Period 2, Ultracet inTreatment Period 3.
492361|NCT00772967|P4|Participant Flow|Placebo, Ultracet, Naproxen|Placebo in Treatment Period 1, Ultracet in Treatment Period 2, Naproxen in Treatment Period 3.
492362|NCT00772967|P3|Participant Flow|Ultracet, Placebo, Naproxen|Ultracet in Treatment Period 1, Placebo in Treatment Period 2, Naproxen in Treatment Period 3.
492363|NCT00772967|P2|Participant Flow|Naproxen, Ultracet, Placebo|Naproxen in Treatment Period 1, Ultracet in Treatment Period 2, Placebo in Treatment Period 3.
492364|NCT00772967|P1|Participant Flow|Placebo, Naproxen, Ultracet|Placebo in Treatment Period 1, Naproxen in Treatment Period 2, Ultracet in Treatment Period 3.
492365|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
492366|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
492367|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
492368|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
492369|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
492370|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
492371|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
492372|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
492373|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
492374|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
492375|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
492376|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
492377|NCT00772967|E3|Reported Event|Ultracet|Participants treated with at least one dose of Ultracet. Two participants were not treated due to discontinuation.
492378|NCT00772967|E2|Reported Event|Naproxen|Participants treated with at least one dose of Naproxen
492379|NCT00772967|E1|Reported Event|Placebo|Participants treated with at least one dose of Placebo
492381|NCT00772954|B3|Baseline|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492382|NCT00772954|B2|Baseline|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492383|NCT00772954|B1|Baseline|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
492384|NCT00772954|P3|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492385|NCT00772954|P2|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492386|NCT00772954|P1|Participant Flow|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
492387|NCT00772954|O3|Outcome|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492388|NCT00772954|O2|Outcome|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492389|NCT00772954|O1|Outcome|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
492390|NCT00772954|E3|Reported Event|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492391|NCT00772954|E2|Reported Event|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
492392|NCT00772954|E1|Reported Event|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
492393|NCT00772941|B1|Baseline|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
492394|NCT00772941|P1|Participant Flow|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
492395|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
492396|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
492397|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
492398|NCT00772941|O2|Outcome|Varenicline - Without Antipsychotics as a Concomitant Drug|Varenicline without Antipsychotics as a Concomitant Drug
492399|NCT00772941|O1|Outcome|Varenicline - With Antipsychotics as a Concomitant Drug|Varenicline with Antipsychotics as a Concomitant Drug
492400|NCT00772941|O2|Outcome|Administration Not Prolonged After 12 Weeks|Participants without prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
492401|NCT00772941|O1|Outcome|Administration Prolonged After 12 Weeks|Participants with prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
492402|NCT00772941|O3|Outcome|>=41 Cigarettes Per Day|Participants with >=41 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
492403|NCT00772941|O2|Outcome|>=21 and <=40 Cigarettes Per Day|Participants with >=21 and <=40 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
492404|NCT00772941|O1|Outcome|<=20 Cigarettes Per Day|Participants with <=20 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
492405|NCT00772941|O6|Outcome|>= 80 kg at Baseline|Participants whose weights at baseline were more than or equal to 80 kg.
492406|NCT00772941|O5|Outcome|>=70 kg and <80 kg at Baseline|Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.
492407|NCT00772941|O4|Outcome|>=60 kg and <70 kg at Baseline|Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.
492408|NCT00772941|O3|Outcome|>=50 kg and <60 kg at Baseline|Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.
492409|NCT00772941|O2|Outcome|>=40 kg and <50 kg at Baseline|Participants whose weights at baseline were more than or equal to 40 kg and less than 50 kg.
492410|NCT00772941|O1|Outcome|<40 kg at Baseline|Participants whose weights at baseline were less than 40 kg.
492411|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Therapies|Participants receiving no concomitant therapies while taking Varenicline according to Japanese Package Insert.
492412|NCT00772941|O1|Outcome|Varenicline - With Concomitant Therapies|Participants receiving concomitant therapies while taking Varenicline according to Japanese Package Insert.
492413|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Drugs|Participants taking no concomitant drugs while taking Varenicline according to Japanese Package Insert.
492414|NCT00772941|O1|Outcome|Varenicline - With Concomitant Drugs|Participants taking concomitant drugs while taking Varenicline according to Japanese Package Insert.
492415|NCT00772941|O2|Outcome|Varenicline - Without Chronic Obstructive Pulmonary Disease|Participants without chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
492416|NCT00772941|O1|Outcome|Varenicline - With Chronic Obstructive Pulmonary Disease|Participants with chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
492417|NCT00772941|O2|Outcome|>=65 Years|Participants with >=65 years taking Varenicline according to Japanese Package Insert.
492418|NCT00772941|O1|Outcome|<65 Years|Participants with <65 years taking Varenicline according to Japanese Package Insert.
492419|NCT00772941|O2|Outcome|Female|Female participants taking Varenicline according to Japanese Package Insert.
492420|NCT00772941|O1|Outcome|Male|Male participants taking Varenicline according to Japanese Package Insert.
492421|NCT00772941|E1|Reported Event|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
492422|NCT00772928|B3|Baseline|Total|Total of all reporting groups
492423|NCT00772928|B2|Baseline|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
492424|NCT00772928|B1|Baseline|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
492563|NCT00772590|E2|Reported Event|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
492425|NCT00772928|P2|Participant Flow|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
492426|NCT00772928|P1|Participant Flow|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
492427|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
492428|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
492429|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
492430|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
492431|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
492432|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
492433|NCT00772928|E2|Reported Event|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
492434|NCT00772928|E1|Reported Event|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
492435|NCT00772915|B1|Baseline|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >~> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
492436|NCT00772915|P1|Participant Flow|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >~> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
492437|NCT00772915|O1|Outcome|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.~Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
492438|NCT00772915|E1|Reported Event|Lenalidomide With On-Demand Dexamethasone|Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
492439|NCT00772889|B4|Baseline|Total|Total of all reporting groups
492440|NCT00772889|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492441|NCT00772889|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492442|NCT00772889|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492443|NCT00772889|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492444|NCT00772889|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492445|NCT00772889|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492446|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492447|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492448|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492449|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492450|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492451|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492452|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492453|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492454|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492455|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492456|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492457|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492458|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492459|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492460|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492461|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492462|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492463|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492464|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492465|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492466|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492467|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492468|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492469|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492470|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492471|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492472|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492473|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492474|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492475|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492476|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492477|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492478|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492479|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492480|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492481|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492482|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492483|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492484|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492485|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492486|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492487|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492488|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492489|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492490|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492491|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492492|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492493|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492494|NCT00772889|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
492495|NCT00772889|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
492496|NCT00772889|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
492497|NCT00772772|B1|Baseline|Vitamin D3|
492498|NCT00772772|P1|Participant Flow|Vitamin D3|Vitamin D3 30,000 units PO weekly for 8 weeks
492499|NCT00772772|O1|Outcome|CKD Patients|
492500|NCT00772772|O1|Outcome|Patients With Chronic Kidney Disease (CKD)|CKD patients who were Vitamin D deficient and received Vitamin D3 repletion
492501|NCT00772772|E1|Reported Event|Vitamin D3|
492502|NCT00772707|B1|Baseline|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
492503|NCT00772707|P1|Participant Flow|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
492504|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
492505|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
492506|NCT00772707|E1|Reported Event|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
492507|NCT00772668|B1|Baseline|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
492508|NCT00772668|P1|Participant Flow|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
492509|NCT00772668|O1|Outcome|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab: Administered intravenously during induction and maintenance therapy per protocol.~Bortezomib: Administered intravenously per protocol.~Cyclophosphamide: Administered intravenously per protocol.~Prednisone: Administered orally (PO) per protocol."
492510|NCT00772668|O1|Outcome|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab: Administered intravenously during induction and maintenance therapy per protocol.~Bortezomib: Administered intravenously per protocol.~Cyclophosphamide: Administered intravenously per protocol.~Prednisone: Administered orally (PO) per protocol."
492511|NCT00772668|O1|Outcome|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab: Administered intravenously during induction and maintenance therapy per protocol.~Bortezomib: Administered intravenously per protocol.~Cyclophosphamide: Administered intravenously per protocol.~Prednisone: Administered orally (PO) per protocol."
492512|NCT00772668|O1|Outcome|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
492513|NCT00772668|E1|Reported Event|RCVELP|"Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):~Rituximab~Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles~Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles~Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles~Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles~Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles"
492514|NCT00772629|B3|Baseline|Total|Total of all reporting groups
492515|NCT00772629|B2|Baseline|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
492516|NCT00772629|B1|Baseline|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
492517|NCT00772629|P2|Participant Flow|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
492518|NCT00772629|P1|Participant Flow|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
492519|NCT00772629|O2|Outcome|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
492520|NCT00772629|O1|Outcome|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
492521|NCT00772629|E2|Reported Event|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
492522|NCT00772629|E1|Reported Event|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
492523|NCT00772603|B4|Baseline|Total|Total of all reporting groups
492524|NCT00772603|B3|Baseline|Placebo|Placebo given once daily.
492525|NCT00772603|B2|Baseline|1200mg/Day SPN-804|1200mg SPN-804O given once daily
492526|NCT00772603|B1|Baseline|2400mg/Day SPN-804|2400mg SPN-804O once daily
492527|NCT00772603|P3|Participant Flow|Placebo|Placebo once daily
492528|NCT00772603|P2|Participant Flow|1200mg/Day SPN-804|1200mg SPN-804O once daily
492529|NCT00772603|P1|Participant Flow|2400mg/Day SPN-804|2400mg of SPN-804O once daily
492530|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
492531|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
492532|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
492533|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
492534|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
492535|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
492536|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
492537|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
492538|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
492539|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
492540|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
492541|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
492542|NCT00772603|O3|Outcome|Placebo|Placebo once daily.
492543|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804 once daily
492544|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804 once daily
492545|NCT00772603|E3|Reported Event|Placebo|placebo QD, given as four placebo tablets
492546|NCT00772603|E2|Reported Event|1200mg/Day SPN-804|1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets.
492547|NCT00772603|E1|Reported Event|2400mg/Day SPN-804|2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets
492548|NCT00772590|B5|Baseline|Total|Total of all reporting groups
492549|NCT00772590|B4|Baseline|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
492550|NCT00772590|B3|Baseline|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
492551|NCT00772590|B2|Baseline|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
492552|NCT00772590|B1|Baseline|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
492553|NCT00772590|P4|Participant Flow|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
492554|NCT00772590|P3|Participant Flow|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
492555|NCT00772590|P2|Participant Flow|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
492564|NCT00772590|E1|Reported Event|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
492565|NCT00772577|B3|Baseline|Total|Total of all reporting groups
492566|NCT00772577|B2|Baseline|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492567|NCT00772577|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492568|NCT00772577|P2|Participant Flow|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492569|NCT00772577|P1|Participant Flow|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492570|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492571|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492572|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492573|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492574|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492575|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492576|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492577|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492578|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492579|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492580|NCT00772577|E2|Reported Event|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
492581|NCT00772577|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
492582|NCT00772538|B3|Baseline|Total|Total of all reporting groups
492583|NCT00772538|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492584|NCT00772538|B1|Baseline|Placebo|Patients treated with matching placebo
492585|NCT00772538|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492586|NCT00772538|P1|Participant Flow|Placebo|Patients treated with matching placebo
492587|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492588|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492589|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492590|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492591|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492592|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492593|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492594|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492595|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492596|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492597|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492598|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492599|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492600|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492601|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492602|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492603|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492604|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492605|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492606|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492607|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492608|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492609|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492610|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492611|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492612|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492613|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492614|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492615|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492616|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492617|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492618|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492619|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492620|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492621|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492622|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492623|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492624|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492625|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492626|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492627|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492628|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492629|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492633|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492634|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492635|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492636|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492637|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492638|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492639|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492640|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492641|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492642|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492643|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492644|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492645|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492646|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492647|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492648|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492649|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492650|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492651|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
492652|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
492653|NCT00772538|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 Î¼g qd
492654|NCT00772538|E1|Reported Event|Placebo|Patients treated with matching placebo
492655|NCT00772447|B3|Baseline|Total|Total of all reporting groups
492656|NCT00772447|B2|Baseline|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492657|NCT00772447|B1|Baseline|Daptomycin|daptomycin 4mg/kg iv every 24hours
492658|NCT00772447|P2|Participant Flow|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492659|NCT00772447|P1|Participant Flow|Daptomycin|daptomycin 4mg/kg iv every 24hours
492660|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492661|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492662|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492663|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492664|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492665|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492666|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492667|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492668|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492669|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492670|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492671|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492672|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492673|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492674|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492675|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492676|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492677|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492678|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492679|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492680|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492681|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492682|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492683|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
492684|NCT00772447|E2|Reported Event|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
492685|NCT00772447|E1|Reported Event|Daptomycin|daptomycin 4mg/kg iv every 24hours
492686|NCT00772382|B1|Baseline|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
492687|NCT00772382|P1|Participant Flow|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
492688|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
492689|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
492690|NCT00772382|E1|Reported Event|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
492691|NCT00772369|B1|Baseline|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
492692|NCT00772369|P1|Participant Flow|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
492693|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
492694|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
492695|NCT00772369|E1|Reported Event|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
492696|NCT00772304|B1|Baseline|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
492697|NCT00772304|P1|Participant Flow|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
492698|NCT00772304|O1|Outcome|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
492699|NCT00772304|E1|Reported Event|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
492700|NCT00772148|B3|Baseline|Total|Total of all reporting groups
492701|NCT00772148|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492702|NCT00772148|B1|Baseline|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492703|NCT00772148|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492704|NCT00772148|P1|Participant Flow|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492705|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492706|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492707|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492708|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492709|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492710|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492711|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492712|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492713|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
504238|NCT00746733|E4|Reported Event|Adderall XR + Prilosec OTC|
492714|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492715|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492716|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492717|NCT00772148|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
492718|NCT00772148|E1|Reported Event|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
492719|NCT00772109|B5|Baseline|Total|Total of all reporting groups
492720|NCT00772109|B4|Baseline|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
492721|NCT00772109|B3|Baseline|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
492722|NCT00772109|B2|Baseline|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
492723|NCT00772109|B1|Baseline|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
492724|NCT00772109|P4|Participant Flow|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
492725|NCT00772109|P3|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
492726|NCT00772109|P2|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
492727|NCT00772109|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
492728|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
492729|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
492730|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
492731|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
492732|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
492733|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
492734|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
492735|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
492736|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
492737|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
492738|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
492739|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
492740|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
492741|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
492742|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
492743|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
492744|NCT00772109|E4|Reported Event|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
492745|NCT00772109|E3|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
492746|NCT00772109|E2|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
492747|NCT00772109|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
492748|NCT00772070|B3|Baseline|Total|Total of all reporting groups
492749|NCT00772070|B2|Baseline|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
504239|NCT00746733|E3|Reported Event|Vyvanse + Prilosec OTC|
492750|NCT00772070|B1|Baseline|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
492751|NCT00772070|P2|Participant Flow|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
492752|NCT00772070|P1|Participant Flow|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
492753|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
492754|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
492755|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
492756|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
492757|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
492758|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
492759|NCT00772070|E2|Reported Event|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
492760|NCT00772070|E1|Reported Event|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
492761|NCT00772031|B3|Baseline|Total|Total of all reporting groups
492762|NCT00772031|B2|Baseline|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
492763|NCT00772031|B1|Baseline|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492764|NCT00772031|P2|Participant Flow|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
492765|NCT00772031|P1|Participant Flow|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492766|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
492767|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492768|NCT00772031|O4|Outcome|Topiramate Plus Placebo, Prior, Stable Topiramate|Participants with prior stable topiramate use received a placebo and topiramate.
492769|NCT00772031|O3|Outcome|Topiramate Plus Propranolol, Prior, Stable Topiramate|Participants with prior stable topiramate use received propranolol and topiramate.
492770|NCT00772031|O2|Outcome|Topiramate Plus Placebo, no Prior, Stable Topiramate|Participants without prior stable topiramate use received a placebo and topiramate.
492771|NCT00772031|O1|Outcome|Topiramate Plus Propranolol, no Prior, Stable Topiramate|Participants without prior stable topiramate use received propranolol and topiramate.
492772|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
492773|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492774|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
492775|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492776|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
492777|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492778|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
492779|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492780|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
492781|NCT00772031|O1|Outcome|Topiramate Plus Proporanolol|Participants will receive propranolol and topiramate.
492782|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
492783|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492784|NCT00772031|E2|Reported Event|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
492785|NCT00772031|E1|Reported Event|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
492786|NCT00772005|B5|Baseline|Total|Total of all reporting groups
492787|NCT00772005|B4|Baseline|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492788|NCT00772005|B3|Baseline|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492789|NCT00772005|B2|Baseline|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493498|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
493499|NCT00771927|E2|Reported Event|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
492790|NCT00772005|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492791|NCT00772005|P4|Participant Flow|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492792|NCT00772005|P3|Participant Flow|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492793|NCT00772005|P2|Participant Flow|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492794|NCT00772005|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492795|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492796|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492797|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492798|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492799|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492800|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493500|NCT00771927|E1|Reported Event|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
493501|NCT00771914|B5|Baseline|Total|Total of all reporting groups
493502|NCT00771914|B4|Baseline|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
504240|NCT00746733|E2|Reported Event|Adderall XR|
492801|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492802|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492803|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492804|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492805|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492806|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492807|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492808|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492809|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492810|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492811|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493503|NCT00771914|B3|Baseline|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
493504|NCT00771914|B2|Baseline|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
493505|NCT00771914|B1|Baseline|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
492812|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492813|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492814|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492815|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492816|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492817|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492818|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492819|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492820|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492821|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492822|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493506|NCT00771914|P4|Participant Flow|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
493507|NCT00771914|P3|Participant Flow|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81 mg of Aspirin
493810|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
492823|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492824|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492825|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492826|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492827|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492828|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492829|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492830|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492831|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492832|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492833|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493508|NCT00771914|P2|Participant Flow|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza, then 4 grams of Lovaza, then 81mg of Aspirin
493509|NCT00771914|P1|Participant Flow|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
493510|NCT00771914|O4|Outcome|Both Aspirin and Lovaza|All participants received Aspirin and Lovaza intervention regardless of sequence.
492834|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492835|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492836|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492837|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492838|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492839|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492840|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492841|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492842|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492843|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492844|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493511|NCT00771914|O3|Outcome|Lovaza|All participants received Lovaza intervention regardless of sequence.
493512|NCT00771914|O2|Outcome|Aspirin|All participants received Aspirin intervention regardless of sequence.
493513|NCT00771914|O1|Outcome|Placebo|All participants received Placebo intervention regardless of sequence.
493514|NCT00771914|E4|Reported Event|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
492845|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492846|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492847|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492848|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492849|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492850|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492851|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492852|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492853|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492854|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492855|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493515|NCT00771914|E3|Reported Event|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
493516|NCT00771914|E2|Reported Event|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
493811|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
492856|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492857|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492858|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492859|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492860|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492861|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492862|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492863|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492864|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492865|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492866|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493517|NCT00771914|E1|Reported Event|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
493518|NCT00771901|B4|Baseline|Total|Total of all reporting groups
493519|NCT00771901|B3|Baseline|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
494236|NCT00770861|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
492867|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492868|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492869|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492870|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492871|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492872|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492873|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492874|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492875|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492876|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492877|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493520|NCT00771901|B2|Baseline|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
493521|NCT00771901|B1|Baseline|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
493522|NCT00771901|P3|Participant Flow|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
492878|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492879|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492880|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492881|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492882|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492883|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492884|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492885|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492886|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492887|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492888|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493523|NCT00771901|P2|Participant Flow|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
493524|NCT00771901|P1|Participant Flow|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
493525|NCT00771901|O3|Outcome|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
492889|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492890|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492891|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492892|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492893|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492894|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492895|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492896|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492897|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492898|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492899|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493526|NCT00771901|O2|Outcome|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
493527|NCT00771901|O1|Outcome|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
493528|NCT00771901|O3|Outcome|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
492900|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492901|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492902|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492903|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492904|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492905|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492906|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492907|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492908|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492909|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492910|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493529|NCT00771901|O2|Outcome|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
493530|NCT00771901|O1|Outcome|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
493531|NCT00771901|O3|Outcome|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
492911|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492912|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492913|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492914|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492915|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492916|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492917|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492918|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492919|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492920|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492921|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493532|NCT00771901|O2|Outcome|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
493533|NCT00771901|O1|Outcome|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
493534|NCT00771901|E3|Reported Event|Sodium Phenylbutyrate|"Subjects will receive sodium phenylbutyrate for four weeks.~sodium phenylbutyrate: 20g/day for four weeks."
492922|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492923|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492924|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492925|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492926|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492927|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492928|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492929|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492930|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492931|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492932|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493535|NCT00771901|E2|Reported Event|Tauroursodeoxycholic Acid|"Subjects will receive tauroursodeoxycholic acid for four weeks.~tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner."
493536|NCT00771901|E1|Reported Event|Placebo|"Subjects will be given a placebo rather than tauroursodeoxycholic acid.~placebo: 7 pills daily for 4 weeks"
493537|NCT00771875|B4|Baseline|Total|Total of all reporting groups
504241|NCT00746733|E1|Reported Event|Vyvanse|
492933|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492934|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492935|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492936|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492937|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492938|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492939|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492940|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492941|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492942|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492943|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493538|NCT00771875|B3|Baseline|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493539|NCT00771875|B2|Baseline|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
492944|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492945|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492946|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492947|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492948|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492949|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492950|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492951|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492952|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492953|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492954|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493556|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493557|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
492955|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492956|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492957|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492958|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492959|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492960|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492961|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492962|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492963|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492964|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492965|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493589|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493590|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493591|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494658|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
492966|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492967|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492968|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492969|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492970|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492971|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492972|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492973|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492974|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492975|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492976|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493592|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493593|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493594|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494659|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
492977|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492978|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492979|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492980|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492981|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492982|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492983|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492984|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492985|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492986|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492987|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493595|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493596|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493597|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494660|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
492988|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492989|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492990|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492991|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492992|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492993|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492994|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492995|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492996|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492997|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
492998|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493598|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493599|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493600|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494661|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
492999|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493000|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493001|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493002|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493003|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493004|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493005|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493006|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493007|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493008|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493009|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493601|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493602|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493603|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494662|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
493010|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493011|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493012|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493013|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493014|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493015|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493016|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493017|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493018|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493019|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493020|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493604|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493605|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493606|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494663|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
493021|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493022|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493023|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493024|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493025|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493026|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493027|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493028|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493029|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493030|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493031|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493607|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493608|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493609|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494664|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
493032|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493033|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493034|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493035|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493036|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493037|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493038|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493039|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493040|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493041|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493042|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493610|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493611|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493612|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494665|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
493043|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493044|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493045|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493046|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493047|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493048|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493049|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493050|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493051|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493052|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493053|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493613|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493614|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493615|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494666|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
493054|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493055|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493056|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493057|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493058|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493059|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493060|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493061|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493062|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493063|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493064|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493616|NCT00771810|E3|Reported Event|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493617|NCT00771810|E2|Reported Event|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493618|NCT00771810|E1|Reported Event|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
493619|NCT00771758|B4|Baseline|Total|Total of all reporting groups
493065|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493066|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493067|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493068|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493069|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493070|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493071|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493072|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493073|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493074|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493075|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493620|NCT00771758|B3|Baseline|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493621|NCT00771758|B2|Baseline|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493622|NCT00771758|B1|Baseline|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493623|NCT00771758|P3|Participant Flow|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493076|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493077|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493078|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493079|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493080|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493081|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493082|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493083|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493084|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493085|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493086|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493624|NCT00771758|P2|Participant Flow|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493625|NCT00771758|P1|Participant Flow|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493626|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493627|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493087|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493088|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493089|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493090|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493091|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493092|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493093|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493094|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493095|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493096|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493097|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493628|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493629|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493630|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493631|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493098|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493099|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493100|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493101|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493102|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493103|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493104|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493105|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493106|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493107|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493108|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493632|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493633|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493634|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493635|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506136|NCT00740779|P3|Participant Flow|Placebo|1 placebo capsule daily
493109|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493110|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493111|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493112|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493113|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493114|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493115|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493116|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493117|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493118|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493119|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493636|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493637|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493638|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493639|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493120|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493121|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493122|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493123|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493124|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493125|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493126|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493127|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493128|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493129|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493130|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493640|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493641|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493642|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493643|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493131|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493132|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493133|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493134|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493135|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493136|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493137|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493138|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493139|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493140|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493141|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493644|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493645|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493646|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493647|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506137|NCT00740779|P2|Participant Flow|Silodosin 8 mg|Silodosin 8 mg daily
493142|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493143|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493144|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493145|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493146|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493147|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493148|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493149|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493150|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493151|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493152|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493648|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493649|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493650|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493651|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493153|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493154|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493155|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493156|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493157|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493158|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493159|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493160|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493161|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493162|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493163|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493652|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493653|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493654|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493655|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493164|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493165|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493166|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493167|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493168|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493169|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493170|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493171|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493172|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493173|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493174|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493656|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493657|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493658|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493659|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506138|NCT00740779|P1|Participant Flow|Silodosin 4 mg|Silodosin 4 mg daily
493175|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493176|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493177|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493178|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493179|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493180|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493181|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493182|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493183|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493184|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493185|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493660|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493661|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493662|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493663|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493186|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493187|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493188|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493189|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493190|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493191|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493192|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493193|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493194|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493195|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493196|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493664|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493665|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493666|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493667|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493197|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493198|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493199|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493200|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493201|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493202|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493203|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493204|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493205|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493206|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493207|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493668|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493669|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493670|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493671|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506139|NCT00740779|O3|Outcome|Placebo|1 placebo capsule daily
493208|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493209|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493210|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493211|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493212|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493213|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493214|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493215|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493216|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493217|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493218|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493672|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493673|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493674|NCT00771758|O5|Outcome|Baseline Total|Placebo
493675|NCT00771758|O4|Outcome|Poor - End of Study|Placebo
493676|NCT00771758|O3|Outcome|Fair - End of Study|Placebo
493219|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493220|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493221|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493222|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493223|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493224|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493225|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493226|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493227|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493228|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493229|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493677|NCT00771758|O2|Outcome|Good - End of Study|Placebo
493678|NCT00771758|O1|Outcome|Excellent - End of Study|Placebo
493679|NCT00771758|O6|Outcome|Baseline Total|Oxycodone IR
493680|NCT00771758|O5|Outcome|Missing - End of Study|Oxycodone IR
493681|NCT00771758|O4|Outcome|Poor - End of Study|Oxycodone IR
493682|NCT00771758|O3|Outcome|Fair - End of Study|Oxycodone IR
493683|NCT00771758|O2|Outcome|Good - End of Study|Oxycodone IR
493230|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493231|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493232|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493233|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493234|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493235|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493236|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493237|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493238|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493239|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493240|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493684|NCT00771758|O1|Outcome|Excellent - End of Study|Oxycodone IR
493685|NCT00771758|O6|Outcome|Baseline Total|Tapentadol IR
493686|NCT00771758|O5|Outcome|Missing - End of Study|Tapentadol IR
493687|NCT00771758|O4|Outcome|Poor - End of Study|Tapentadol IR
493688|NCT00771758|O3|Outcome|Fair - End of Study|Tapentadol IR
493689|NCT00771758|O2|Outcome|Good - End of Study|Tapentadol IR
493690|NCT00771758|O1|Outcome|Excellent - End of Study|Tapentadol IR
493241|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493242|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493243|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493244|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493245|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493246|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493247|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493248|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493249|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493250|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493251|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493691|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493692|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493693|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493694|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506140|NCT00740779|O2|Outcome|Silodosin 8 mg|Silodosin 8 mg daily
493252|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493253|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493254|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493255|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493256|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493257|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493258|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493259|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493260|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493261|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493262|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493695|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493696|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493697|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493698|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493263|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493264|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493265|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493266|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493267|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493268|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493269|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493270|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493271|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493272|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493273|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493699|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493700|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493701|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493702|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493274|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493275|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493276|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493277|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493278|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493279|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493280|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493281|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493282|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493283|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493284|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493703|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493704|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493705|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493706|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506141|NCT00740779|O1|Outcome|Silodosin 4 mg|Silodosin 4 mg daily
493285|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493286|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493287|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493288|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493289|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493290|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493291|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493292|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493293|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493294|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493295|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493707|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493708|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493709|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493710|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493296|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493297|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493298|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493299|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493300|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493301|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493302|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493303|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493304|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493305|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493306|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493711|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493712|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493713|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493714|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493307|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493308|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493309|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493310|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493311|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493312|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493313|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493314|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493315|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493316|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493317|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493715|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493716|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493717|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493718|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506142|NCT00740779|E3|Reported Event|Placebo|1 placebo capsule daily
493318|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493319|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493320|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493321|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493322|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493323|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493324|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493325|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493326|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493327|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493328|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493719|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493720|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493721|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493722|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493329|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493330|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493331|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493332|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493333|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493334|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493335|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493336|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493337|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493338|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493339|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493723|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493724|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493725|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493726|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493340|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493341|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493342|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493343|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493344|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493345|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493346|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493347|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493348|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493349|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493350|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493727|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493728|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493729|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493730|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506143|NCT00740779|E2|Reported Event|Silodosin 8 mg|Silodosin 8 mg daily
493351|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493352|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493353|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493354|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493355|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493356|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493357|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493358|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493359|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493360|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493361|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493731|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493732|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493733|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493734|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493362|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493363|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493364|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493365|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493366|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493367|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493368|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493369|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493370|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493371|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493372|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493735|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493736|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493737|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493738|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493373|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493374|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493375|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493376|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493377|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493378|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493379|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493380|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493381|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493382|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493383|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493739|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493740|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493741|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493742|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
506144|NCT00740779|E1|Reported Event|Silodosin 4 mg|Silodosin 4 mg daily
493384|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493385|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493386|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493387|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493388|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493389|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493390|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493391|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493392|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493393|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493394|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493743|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493744|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493745|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493746|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493395|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493396|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493397|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493398|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493399|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493400|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493401|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493402|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493403|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493404|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493405|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493747|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493748|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493749|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493750|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493406|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493407|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493408|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493409|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493410|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493411|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493412|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493413|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493414|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493415|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493416|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493751|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493752|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493753|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493754|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
508004|NCT00735787|B3|Baseline|Total|Total of all reporting groups
493417|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493418|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493419|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493420|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493421|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493422|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493423|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493424|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493425|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493426|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493427|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493755|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493756|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493757|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493758|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493428|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493429|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493430|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493431|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493432|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493433|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493434|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493435|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493436|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493437|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493438|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493759|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493760|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493761|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493762|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493439|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493440|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493441|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493442|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493443|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493444|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493445|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493446|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493447|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493448|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493449|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493763|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493764|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493765|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493766|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
508683|NCT00734474|B10|Baseline|Total|Total of all reporting groups
493450|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493451|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493452|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493453|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493454|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493455|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493456|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493457|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493458|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493459|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493460|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493767|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493768|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493769|NCT00771758|E3|Reported Event|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
493770|NCT00771758|E2|Reported Event|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
493461|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493462|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493463|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493464|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493465|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493466|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493467|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493468|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493469|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493470|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493471|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493771|NCT00771758|E1|Reported Event|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
493772|NCT00771745|B3|Baseline|Total|Total of all reporting groups
493812|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493813|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
512681|NCT00727246|B5|Baseline|Total|Total of all reporting groups
493472|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493473|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493474|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493475|NCT00772005|E4|Reported Event|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493476|NCT00772005|E3|Reported Event|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493477|NCT00772005|E2|Reported Event|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493478|NCT00772005|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
493479|NCT00771953|B3|Baseline|Total|Total of all reporting groups
493480|NCT00771953|B2|Baseline|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
493481|NCT00771953|B1|Baseline|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
493482|NCT00771953|P2|Participant Flow|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
493483|NCT00771953|P1|Participant Flow|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
493484|NCT00771953|O4|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed 500mg/m2 q21 days
493485|NCT00771953|O3|Outcome|Apricoxib Plus Pemetrexed|Apricoxib 400mg qd plus pemetrexed 500mg/m2 q21 days
493486|NCT00771953|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel 75mg/m2 q21 days
493487|NCT00771953|O1|Outcome|Apricoxib Plus Docetaxel|Apricoxib 400mg qd plus docetaxel 75mg/m2 q21 days
493488|NCT00771953|E2|Reported Event|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
493489|NCT00771953|E1|Reported Event|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
493490|NCT00771927|B3|Baseline|Total|Total of all reporting groups
493491|NCT00771927|B2|Baseline|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
493492|NCT00771927|B1|Baseline|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
493493|NCT00771927|P2|Participant Flow|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
493494|NCT00771927|P1|Participant Flow|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
493495|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
493496|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
493497|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
514281|NCT00723229|B3|Baseline|Total|Total of all reporting groups
493540|NCT00771875|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493541|NCT00771875|P3|Participant Flow|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493542|NCT00771875|P2|Participant Flow|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493543|NCT00771875|P1|Participant Flow|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on cluster of differentiation 3 (CD3) count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via intravenous push (IVP) over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493544|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493545|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493546|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493547|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493548|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493549|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493550|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493551|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493552|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493553|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493554|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493555|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493808|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493809|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
493558|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493559|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493560|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493561|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493562|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493563|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493564|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493565|NCT00771875|E3|Reported Event|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493566|NCT00771875|E2|Reported Event|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
493567|NCT00771875|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
493568|NCT00771849|B3|Baseline|Total|Total of all reporting groups
493569|NCT00771849|B2|Baseline|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
493570|NCT00771849|B1|Baseline|Menactra® Vaccine Group|Participants received Menactra® Vaccine
493571|NCT00771849|P2|Participant Flow|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
493572|NCT00771849|P1|Participant Flow|Menactra® Vaccine Group|Participants received Menactra® Vaccine
493573|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
493574|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
493575|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
493576|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
493577|NCT00771849|E2|Reported Event|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
493578|NCT00771849|E1|Reported Event|Menactra® Vaccine Group|Participants received Menactra® Vaccine
493579|NCT00771810|B4|Baseline|Total|Total of all reporting groups
493580|NCT00771810|B3|Baseline|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493581|NCT00771810|B2|Baseline|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493582|NCT00771810|B1|Baseline|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
493583|NCT00771810|P3|Participant Flow|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493584|NCT00771810|P2|Participant Flow|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493585|NCT00771810|P1|Participant Flow|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
493586|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
493587|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
493588|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
494667|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
493773|NCT00771745|B2|Baseline|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
493774|NCT00771745|B1|Baseline|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
493775|NCT00771745|P2|Participant Flow|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
493776|NCT00771745|P1|Participant Flow|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
493777|NCT00771745|O2|Outcome|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
493778|NCT00771745|O1|Outcome|Preloading Induction With Thymoglobulin x 4 Doses|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
493779|NCT00771745|E2|Reported Event|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
493780|NCT00771745|E1|Reported Event|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
493781|NCT00771667|B5|Baseline|Total|Total of all reporting groups
493782|NCT00771667|B4|Baseline|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493783|NCT00771667|B3|Baseline|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
493784|NCT00771667|B2|Baseline|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
493785|NCT00771667|B1|Baseline|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
493786|NCT00771667|P10|Participant Flow|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
493787|NCT00771667|P9|Participant Flow|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
493788|NCT00771667|P8|Participant Flow|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
493789|NCT00771667|P7|Participant Flow|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
493790|NCT00771667|P6|Participant Flow|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
493791|NCT00771667|P5|Participant Flow|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
493792|NCT00771667|P4|Participant Flow|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493793|NCT00771667|P3|Participant Flow|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
493794|NCT00771667|P2|Participant Flow|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
493795|NCT00771667|P1|Participant Flow|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
493796|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
493797|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
493798|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
493799|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
493800|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493801|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
493802|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
493803|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
493804|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493805|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
493806|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
493807|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
493814|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
493815|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
493816|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493817|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
493818|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
493819|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
493820|NCT00771667|E10|Reported Event|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
493821|NCT00771667|E9|Reported Event|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
493822|NCT00771667|E8|Reported Event|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
493823|NCT00771667|E7|Reported Event|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
493824|NCT00771667|E6|Reported Event|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
493825|NCT00771667|E5|Reported Event|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
493826|NCT00771667|E4|Reported Event|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
493827|NCT00771667|E3|Reported Event|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
493828|NCT00771667|E2|Reported Event|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
493829|NCT00771667|E1|Reported Event|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
493830|NCT00771615|B10|Baseline|Total|Total of all reporting groups
493831|NCT00771615|B9|Baseline|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493832|NCT00771615|B8|Baseline|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493833|NCT00771615|B7|Baseline|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493834|NCT00771615|B6|Baseline|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493835|NCT00771615|B5|Baseline|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493836|NCT00771615|B4|Baseline|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493837|NCT00771615|B3|Baseline|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493838|NCT00771615|B2|Baseline|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493839|NCT00771615|B1|Baseline|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493840|NCT00771615|P9|Participant Flow|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493841|NCT00771615|P8|Participant Flow|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
514282|NCT00723229|B2|Baseline|Acyclovir 400 mg Twice Daily|
493842|NCT00771615|P7|Participant Flow|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493843|NCT00771615|P6|Participant Flow|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493844|NCT00771615|P5|Participant Flow|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493845|NCT00771615|P4|Participant Flow|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493846|NCT00771615|P3|Participant Flow|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493847|NCT00771615|P2|Participant Flow|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493848|NCT00771615|P1|Participant Flow|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493849|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493850|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493851|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493852|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493853|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493854|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493855|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493856|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493857|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493858|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493859|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494457|NCT00770484|O2|Outcome|Placebo|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
493860|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493861|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493862|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493863|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493864|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493865|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493866|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493867|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493868|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493869|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493870|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493871|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493872|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493873|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493874|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493875|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493876|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493877|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494139|NCT00771316|E1|Reported Event|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
493878|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493879|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493880|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493881|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493882|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493883|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493884|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493885|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493886|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493887|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493888|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493889|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493890|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493891|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493892|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493893|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493894|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494030|NCT00771615|E8|Reported Event|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493895|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493896|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493897|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493898|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493899|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493900|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493901|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493902|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493903|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493904|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493905|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494062|NCT00771537|B6|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494140|NCT00771277|B1|Baseline|Arm 1|Family experience of concerns and providing support to TBI patient
493906|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493907|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493908|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493909|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493910|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493911|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493912|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493913|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493914|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493915|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493916|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494063|NCT00771537|B5|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494668|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
493917|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493918|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493919|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493920|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493921|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493922|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493923|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493924|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493925|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493926|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493927|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494064|NCT00771537|B4|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
514283|NCT00723229|B1|Baseline|No Medication|
493928|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493929|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493930|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493931|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493932|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493933|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493934|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493935|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493936|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493937|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493938|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493939|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493940|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493941|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493942|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493943|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493944|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493945|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493946|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493947|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493948|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493949|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493950|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494065|NCT00771537|B3|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
515793|NCT00719810|P1|Participant Flow|Delafloxacin 300 mg IV q12h|
493951|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493952|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493953|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493954|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493955|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493956|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493957|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493958|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493959|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493960|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493961|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494066|NCT00771537|B2|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494669|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
493962|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493963|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493964|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493965|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493966|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493967|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493968|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493969|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493970|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493971|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493972|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494067|NCT00771537|B1|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494670|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
493973|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493974|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493975|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493976|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493977|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493978|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493979|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493980|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493981|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493982|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493983|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493984|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493985|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493986|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493987|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493988|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493989|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493990|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493991|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493992|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
493993|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493994|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493995|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494068|NCT00771537|P16|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
493996|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493997|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493998|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
493999|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494000|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494001|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494002|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494003|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494004|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494005|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494006|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494069|NCT00771537|P15|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494007|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494008|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494009|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494010|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494011|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494012|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494013|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494014|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494015|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494016|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494017|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494070|NCT00771537|P14|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
515796|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
494018|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494019|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494020|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494021|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494022|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494023|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494024|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494025|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494026|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494027|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
494028|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494029|NCT00771615|E9|Reported Event|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494138|NCT00771316|E2|Reported Event|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
494031|NCT00771615|E7|Reported Event|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494032|NCT00771615|E6|Reported Event|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494033|NCT00771615|E5|Reported Event|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494034|NCT00771615|E4|Reported Event|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494035|NCT00771615|E3|Reported Event|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494036|NCT00771615|E2|Reported Event|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494037|NCT00771615|E1|Reported Event|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
494038|NCT00771602|B4|Baseline|Total|Total of all reporting groups
494039|NCT00771602|B3|Baseline|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
494040|NCT00771602|B2|Baseline|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
494041|NCT00771602|B1|Baseline|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
494042|NCT00771602|P3|Participant Flow|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
494043|NCT00771602|P2|Participant Flow|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
494044|NCT00771602|P1|Participant Flow|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
494045|NCT00771602|O3|Outcome|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
494046|NCT00771602|O2|Outcome|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
494047|NCT00771602|O1|Outcome|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
494048|NCT00771602|E3|Reported Event|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
494049|NCT00771602|E2|Reported Event|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
494050|NCT00771602|E1|Reported Event|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
494051|NCT00771537|B17|Baseline|Total|Total of all reporting groups
494052|NCT00771537|B16|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494053|NCT00771537|B15|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494054|NCT00771537|B14|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494055|NCT00771537|B13|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494056|NCT00771537|B12|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494057|NCT00771537|B11|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494058|NCT00771537|B10|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494059|NCT00771537|B9|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494060|NCT00771537|B8|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494061|NCT00771537|B7|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494671|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494071|NCT00771537|P13|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494072|NCT00771537|P12|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494073|NCT00771537|P11|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494074|NCT00771537|P10|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494075|NCT00771537|P9|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494076|NCT00771537|P8|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494077|NCT00771537|P7|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494078|NCT00771537|P6|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494079|NCT00771537|P5|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494080|NCT00771537|P4|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494081|NCT00771537|P3|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494082|NCT00771537|P2|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494083|NCT00771537|P1|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494084|NCT00771537|O4|Outcome|2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
494085|NCT00771537|O3|Outcome|2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
494086|NCT00771537|O2|Outcome|1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494087|NCT00771537|O1|Outcome|Control/Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494088|NCT00771537|O4|Outcome|2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494089|NCT00771537|O3|Outcome|2-Sided Trivial|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494090|NCT00771537|O2|Outcome|1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494091|NCT00771537|O1|Outcome|Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494092|NCT00771537|E16|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494093|NCT00771537|E15|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494094|NCT00771537|E14|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494095|NCT00771537|E13|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494096|NCT00771537|E12|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494097|NCT00771537|E11|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494179|NCT00771056|E1|Reported Event|Hydroxychloroquine|"Hydroxychloroquine 400 mg po daily for up to one year.~Hydroxychloroquine: 400mg by mouth daily x 1 year"
494098|NCT00771537|E10|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494099|NCT00771537|E9|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494100|NCT00771537|E8|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
494101|NCT00771537|E7|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
494102|NCT00771537|E6|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494103|NCT00771537|E5|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494104|NCT00771537|E4|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
494105|NCT00771537|E3|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
494106|NCT00771537|E2|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
494107|NCT00771537|E1|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
494108|NCT00771472|B1|Baseline|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
494109|NCT00771472|P2|Participant Flow|Part II|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
494110|NCT00771472|P1|Participant Flow|Part I|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
494111|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
494112|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
494113|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
494114|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
494115|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
494116|NCT00771472|O1|Outcome|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
494117|NCT00771472|E1|Reported Event|Vorinostat|Parts I & II: vorinostat(400 mg) Oral, daily (QD). Treatment period was 28 days per cycle.
494118|NCT00771407|B3|Baseline|Total|Total of all reporting groups
494119|NCT00771407|B2|Baseline|Standard Ostomy Construction|Ostomy created in the standard fashion
494120|NCT00771407|B1|Baseline|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
494121|NCT00771407|P2|Participant Flow|Standard Ostomy Construction|Ostomy created in the standard fashion
494122|NCT00771407|P1|Participant Flow|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
494123|NCT00771407|O2|Outcome|Standard Ostomy Construction|Ostomy will be created in the standard fashion
494124|NCT00771407|O1|Outcome|Strattice Fascial Inlay|Strattice will be placed as a fascial inlay to support the ostomy site
494125|NCT00771407|E2|Reported Event|Standard Ostomy Construction|Ostomy created in the standard fashion
494126|NCT00771407|E1|Reported Event|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
494127|NCT00771316|B3|Baseline|Total|Total of all reporting groups
494128|NCT00771316|B2|Baseline|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
494129|NCT00771316|B1|Baseline|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
494130|NCT00771316|P2|Participant Flow|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
494131|NCT00771316|P1|Participant Flow|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
494132|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
494133|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
494134|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
494135|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
494136|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
494137|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
494180|NCT00770991|B3|Baseline|Total|Total of all reporting groups
494141|NCT00771277|P1|Participant Flow|Arm 1|"Use of volunteer support teams to provide services~Support Teams: Use of volunteers organized into teams with a coordinator to provide services to TBI family"
494142|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
494143|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
494144|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
494145|NCT00771277|E1|Reported Event|TBI Caregivers|Family caregivers providing support to TBI patients.
494146|NCT00771264|B3|Baseline|Total|Total of all reporting groups
494147|NCT00771264|B2|Baseline|Sham / Placebo|
494148|NCT00771264|B1|Baseline|Urgent PC|
494149|NCT00771264|P2|Participant Flow|Sham / Placebo|
494150|NCT00771264|P1|Participant Flow|Urgent PC|
494151|NCT00771264|O2|Outcome|Sham / Placebo|
494152|NCT00771264|O1|Outcome|Urgent PC|
494153|NCT00771264|E2|Reported Event|Sham / Placebo|
494154|NCT00771264|E1|Reported Event|Urgent PC|
494155|NCT00771238|B3|Baseline|Total|Total of all reporting groups
494156|NCT00771238|B2|Baseline|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
494157|NCT00771238|B1|Baseline|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
494158|NCT00771238|P2|Participant Flow|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
494159|NCT00771238|P1|Participant Flow|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
494160|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
494161|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
494162|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
494163|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
494164|NCT00771238|E2|Reported Event|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
494165|NCT00771238|E1|Reported Event|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
494166|NCT00771173|B3|Baseline|Total|Total of all reporting groups
494167|NCT00771173|B2|Baseline|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
494168|NCT00771173|B1|Baseline|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
494169|NCT00771173|P2|Participant Flow|Active Agent Group|Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
494170|NCT00771173|P1|Participant Flow|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Blinding: The research pharmacist has facilitated the blinding by placing the active agent (200 mg tablets) into a solid colored capsule. She will make matching placebo capsules filled with lactose powder. To aid in blinding and avoid systemic administration of other dye agents for women in the placebo group, a small amount of orange dye will be placed in the Foley bag. This has been tested in the planning for this trial and is known effectively color the urine orange."
494171|NCT00771173|O2|Outcome|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
494172|NCT00771173|O1|Outcome|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
494173|NCT00771173|E2|Reported Event|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
494174|NCT00771173|E1|Reported Event|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
494175|NCT00771056|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
494176|NCT00771056|P1|Participant Flow|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
494177|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
494178|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
517964|NCT00714571|B7|Baseline|Total|Total of all reporting groups
494181|NCT00770991|B2|Baseline|Two Berry Suppositories Bedtime Plus Placebo Powder|20 g of placebo powder administered as an oral slurry 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
494182|NCT00770991|B1|Baseline|Two Berry Suppositories Bedtime Plus Oral Berry Powder|20 g of lyophilized berry powder administered orally 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
494183|NCT00770991|P2|Participant Flow|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
494184|NCT00770991|P1|Participant Flow|Placebo Powder Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
494185|NCT00770991|O3|Outcome|All Participants|
494186|NCT00770991|O2|Outcome|Lyophilized BRB Suppositories + BRB Slurry|
494187|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories + Placebo|Two, 730 mg BRB suppositories administered at bedtime.
494188|NCT00770991|O2|Outcome|Polyp|all participants used for this analysis
494189|NCT00770991|O1|Outcome|Normal Mucosa|all participants combined for this analysis. Sample of normal mucosa
494190|NCT00770991|O3|Outcome|All Participants|
494191|NCT00770991|O2|Outcome|Lypholized BRB Suppositiry Plus BRB Slurry|2 lyphilized black raspberry suppositories plus black raspberry slurry.
494192|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo|Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
494193|NCT00770991|E2|Reported Event|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
494194|NCT00770991|E1|Reported Event|Black Raspberry Placebo Slurry Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
494195|NCT00770965|B5|Baseline|Total|Total of all reporting groups
494196|NCT00770965|B4|Baseline|Placebo|Participants received placebo to AIN457A IV on day 1.
494197|NCT00770965|B3|Baseline|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
494198|NCT00770965|B2|Baseline|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
494199|NCT00770965|B1|Baseline|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
494200|NCT00770965|P4|Participant Flow|Placebo|Participants received placebo to AIN457A IV on day 1.
494201|NCT00770965|P3|Participant Flow|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
494202|NCT00770965|P2|Participant Flow|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
494203|NCT00770965|P1|Participant Flow|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
494204|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
494205|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
494206|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
494207|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
494208|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
494209|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
494210|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
494211|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
494212|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
494213|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
494214|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
494215|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
494216|NCT00770965|E4|Reported Event|Placebo|Placebo
494217|NCT00770965|E3|Reported Event|AIN457 3 mg/kg|AIN457 3 mg/kg
494218|NCT00770965|E2|Reported Event|AIN457 1 mg/kg|AIN457 1 mg/kg
494219|NCT00770965|E1|Reported Event|AIN457 0.3 mg/kg|AIN457 0.3 mg/kg
494220|NCT00770913|B4|Baseline|Total|Total of all reporting groups
494221|NCT00770913|B3|Baseline|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
494222|NCT00770913|B2|Baseline|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
494223|NCT00770913|B1|Baseline|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
494224|NCT00770913|P3|Participant Flow|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
494225|NCT00770913|P2|Participant Flow|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
494226|NCT00770913|P1|Participant Flow|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
494227|NCT00770913|O3|Outcome|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
494228|NCT00770913|O2|Outcome|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
494229|NCT00770913|O1|Outcome|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
494230|NCT00770913|E3|Reported Event|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
494231|NCT00770913|E2|Reported Event|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
494232|NCT00770913|E1|Reported Event|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
494233|NCT00770861|B3|Baseline|Total|Total of all reporting groups
494234|NCT00770861|B2|Baseline|Placebo|Matching placebo tablets, oral administration
494235|NCT00770861|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
494237|NCT00770861|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
494238|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
494239|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
494240|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
494241|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
494242|NCT00770861|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
494243|NCT00770861|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
494244|NCT00770809|B4|Baseline|Total|Total of all reporting groups
494245|NCT00770809|B3|Baseline|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
494246|NCT00770809|B2|Baseline|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
494247|NCT00770809|B1|Baseline|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
494248|NCT00770809|P3|Participant Flow|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
494249|NCT00770809|P2|Participant Flow|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
494250|NCT00770809|P1|Participant Flow|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
494251|NCT00770809|O3|Outcome|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
494252|NCT00770809|O2|Outcome|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
494253|NCT00770809|O1|Outcome|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
494254|NCT00770809|E3|Reported Event|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
494255|NCT00770809|E2|Reported Event|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
494256|NCT00770809|E1|Reported Event|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
494257|NCT00770770|B3|Baseline|Total|Total of all reporting groups
494258|NCT00770770|B2|Baseline|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
494259|NCT00770770|B1|Baseline|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
494260|NCT00770770|P2|Participant Flow|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
494261|NCT00770770|P1|Participant Flow|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
494262|NCT00770770|O2|Outcome|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
494263|NCT00770770|O1|Outcome|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
494264|NCT00770770|E2|Reported Event|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
494265|NCT00770770|E1|Reported Event|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
494266|NCT00770757|B1|Baseline|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494267|NCT00770757|P1|Participant Flow|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494268|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494269|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494418|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494270|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494271|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494272|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494273|NCT00770757|E1|Reported Event|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
494274|NCT00770692|B5|Baseline|Total|Total of all reporting groups
494275|NCT00770692|B4|Baseline|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494276|NCT00770692|B3|Baseline|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494277|NCT00770692|B2|Baseline|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494278|NCT00770692|B1|Baseline|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494279|NCT00770692|P4|Participant Flow|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494280|NCT00770692|P3|Participant Flow|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494281|NCT00770692|P2|Participant Flow|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494282|NCT00770692|P1|Participant Flow|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494283|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494284|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494285|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494286|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494287|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494288|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494289|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494290|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494291|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494292|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494320|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494293|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494294|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494295|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494296|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494297|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494298|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494299|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494300|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494301|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494302|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494303|NCT00770692|E4|Reported Event|Eszopiclone 2 mg Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494304|NCT00770692|E3|Reported Event|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494305|NCT00770692|E2|Reported Event|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
494306|NCT00770692|E1|Reported Event|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
494307|NCT00770679|B1|Baseline|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
494308|NCT00770679|P1|Participant Flow|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
494309|NCT00770679|O1|Outcome|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
494310|NCT00770679|O1|Outcome|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
494311|NCT00770679|O1|Outcome|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
494312|NCT00770679|E1|Reported Event|High-Dose Statin|"80 mg atorvastatin daily for 3 weeks~lipitor: 80 mg everyday (QD) for 3 weeks"
494313|NCT00770653|B3|Baseline|Total|Total of all reporting groups
494314|NCT00770653|B2|Baseline|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494315|NCT00770653|B1|Baseline|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494316|NCT00770653|P2|Participant Flow|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494317|NCT00770653|P1|Participant Flow|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494318|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494319|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494421|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494321|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494322|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494323|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494324|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494325|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494326|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494327|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494328|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494329|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494330|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494331|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494332|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494333|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494334|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494335|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494336|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494337|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494338|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494339|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494340|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494341|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494342|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494343|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494344|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494345|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494419|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494346|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494347|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494348|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494349|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494350|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494351|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494352|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494353|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494354|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494355|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494356|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494357|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494358|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494359|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494360|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494361|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494362|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494363|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494364|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494365|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494366|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494367|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494368|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494369|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494370|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494420|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494371|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494372|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494373|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494374|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494375|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494376|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494377|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494378|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494379|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494380|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494381|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494382|NCT00770653|E2|Reported Event|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
494383|NCT00770653|E1|Reported Event|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
494384|NCT00770588|B3|Baseline|Total|Total of all reporting groups
494385|NCT00770588|B2|Baseline|Placebo|placebo 1 tablet daily
494386|NCT00770588|B1|Baseline|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494387|NCT00770588|P2|Participant Flow|Placebo|placebo 1 tablet daily
494388|NCT00770588|P1|Participant Flow|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494389|NCT00770588|O2|Outcome|Placebo|Placebo 1 tablet daily
494390|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494391|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
494392|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494393|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
494394|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494395|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
494396|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494397|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
494398|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494399|NCT00770588|E2|Reported Event|Placebo|placebo 1 tablet daily
494400|NCT00770588|E1|Reported Event|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
494401|NCT00770562|B3|Baseline|Total|Total of all reporting groups
494402|NCT00770562|B2|Baseline|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
494403|NCT00770562|B1|Baseline|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
494416|NCT00770510|P1|Participant Flow|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
494672|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
494404|NCT00770562|P2|Participant Flow|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
494405|NCT00770562|P1|Participant Flow|Arm A: Dexamethasone|Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
494406|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
494407|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
494408|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
494409|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
494410|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
494411|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
494412|NCT00770562|E3|Reported Event|Salvage Therapy|Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets <20 x10^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
494413|NCT00770562|E2|Reported Event|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
494414|NCT00770562|E1|Reported Event|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).
494415|NCT00770510|B1|Baseline|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
494417|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494673|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494422|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494423|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494424|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494425|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494426|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494427|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494428|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494429|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494430|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494431|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494432|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494433|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494434|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494435|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494436|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494437|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494438|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494439|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494440|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494441|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494442|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494443|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494444|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494445|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494446|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494447|NCT00770510|E5|Reported Event|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494448|NCT00770510|E4|Reported Event|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494449|NCT00770510|E3|Reported Event|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494450|NCT00770510|E2|Reported Event|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494451|NCT00770510|E1|Reported Event|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
494452|NCT00770484|B3|Baseline|Total|Total of all reporting groups
494453|NCT00770484|B2|Baseline|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
494454|NCT00770484|B1|Baseline|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
494455|NCT00770484|P2|Participant Flow|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
494456|NCT00770484|P1|Participant Flow|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
494458|NCT00770484|O1|Outcome|Propranolol|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
494459|NCT00770484|E2|Reported Event|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
494460|NCT00770484|E1|Reported Event|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
494461|NCT00770432|B3|Baseline|Total|Total of all reporting groups
494462|NCT00770432|B2|Baseline|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
494463|NCT00770432|B1|Baseline|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
494464|NCT00770432|P2|Participant Flow|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
494465|NCT00770432|P1|Participant Flow|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
494466|NCT00770432|O2|Outcome|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
494467|NCT00770432|O1|Outcome|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
494468|NCT00770432|E2|Reported Event|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
494469|NCT00770432|E1|Reported Event|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
494470|NCT00770367|B3|Baseline|Total|Total of all reporting groups
494471|NCT00770367|B2|Baseline|Placebo|The analysis period during which participant took the placebo.
494472|NCT00770367|B1|Baseline|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
494473|NCT00770367|P2|Participant Flow|Placebo|The analysis period during which participant took the placebo.
494474|NCT00770367|P1|Participant Flow|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
494475|NCT00770367|O2|Outcome|Placebo|The analysis period during which participant took the placebo.
494476|NCT00770367|O1|Outcome|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
494477|NCT00770367|E2|Reported Event|Placebo|The analysis period during which participant took the placebo.
494478|NCT00770367|E1|Reported Event|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
494479|NCT00770341|B4|Baseline|Total|Total of all reporting groups
494480|NCT00770341|B3|Baseline|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494481|NCT00770341|B2|Baseline|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494482|NCT00770341|B1|Baseline|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494483|NCT00770341|P3|Participant Flow|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494484|NCT00770341|P2|Participant Flow|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494485|NCT00770341|P1|Participant Flow|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494486|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494487|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494488|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494489|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494490|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494491|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494492|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494493|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494494|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494495|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494496|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494497|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494498|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494499|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494500|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494501|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
494502|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
494503|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
494504|NCT00770341|E4|Reported Event|DAPTOMYCIN (6 MG/KG)|
494505|NCT00770341|E3|Reported Event|VANCOMYCIN|
494506|NCT00770341|E2|Reported Event|DAPTOMYCIN (4 MG/KG)|
494507|NCT00770341|E1|Reported Event|NOT TREATED|
494508|NCT00770328|B3|Baseline|Total|Total of all reporting groups
494509|NCT00770328|B2|Baseline|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
494674|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
494510|NCT00770328|B1|Baseline|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
494511|NCT00770328|P2|Participant Flow|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
494512|NCT00770328|P1|Participant Flow|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
494513|NCT00770328|O2|Outcome|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
494514|NCT00770328|O1|Outcome|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
494515|NCT00770328|O2|Outcome|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
494516|NCT00770328|O1|Outcome|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
494517|NCT00770328|O2|Outcome|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
494518|NCT00770328|O1|Outcome|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
494519|NCT00770328|O2|Outcome|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
494520|NCT00770328|O1|Outcome|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
494521|NCT00770328|E2|Reported Event|Placebo|"Patients take a placebo TID for 8 weeks.~Placebo: PO TID x 8 weeks"
494522|NCT00770328|E1|Reported Event|Pentoxifylline|"Patients receive Pentoxifylline 400 mg po TID for 8 weeks.~Pentoxifylline: 400mg PO TID x 8 weeks"
494523|NCT00770315|B5|Baseline|Total|Total of all reporting groups
494524|NCT00770315|B4|Baseline|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494525|NCT00770315|B3|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494526|NCT00770315|B2|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494527|NCT00770315|B1|Baseline|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494528|NCT00770315|P4|Participant Flow|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494529|NCT00770315|P3|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494530|NCT00770315|P2|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494531|NCT00770315|P1|Participant Flow|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494532|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494533|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494534|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494535|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494536|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494537|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494538|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494539|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494540|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494541|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494542|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494543|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494544|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494545|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494546|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494547|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494548|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494549|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494550|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494551|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494552|NCT00770315|E4|Reported Event|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494553|NCT00770315|E3|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494554|NCT00770315|E2|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494555|NCT00770315|E1|Reported Event|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
494556|NCT00770289|B1|Baseline|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
494557|NCT00770289|P1|Participant Flow|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
494558|NCT00770289|O1|Outcome|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion and did not display remission.
494559|NCT00770289|O3|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
494560|NCT00770289|O2|Outcome|Hamilton Depression Scale (HAM-D7)|Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
494561|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D17)|Participants who were administered HAM-D17.
494562|NCT00770289|O1|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
494563|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D)|Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
494564|NCT00770289|E1|Reported Event|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
494565|NCT00770211|B3|Baseline|Total|Total of all reporting groups
494566|NCT00770211|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494567|NCT00770211|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494568|NCT00770211|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494569|NCT00770211|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494570|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494571|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494572|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494573|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494574|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494575|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494576|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494622|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494577|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494578|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494579|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494580|NCT00770211|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
494581|NCT00770211|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494582|NCT00770146|B3|Baseline|Total|Total of all reporting groups
494583|NCT00770146|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494584|NCT00770146|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494585|NCT00770146|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494586|NCT00770146|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494587|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494588|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494589|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494590|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494591|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494592|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494593|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494594|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494595|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494596|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494597|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494598|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494599|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494600|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494601|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494602|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494603|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494604|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494605|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494606|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494607|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494608|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494609|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494610|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494611|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494612|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494613|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494614|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494615|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494616|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494617|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494618|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494619|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494620|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494621|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
518207|NCT00713661|B3|Baseline|Group 3: Laparoscopic Surgery Lower|
494623|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494624|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494625|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494626|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494627|NCT00770146|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
494628|NCT00770146|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
494629|NCT00770120|B1|Baseline|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
494630|NCT00770120|P1|Participant Flow|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
494631|NCT00770120|O1|Outcome|Everolimus|Daily oral Everolimus 10 mg/day
494632|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
494633|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
494634|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
494635|NCT00770120|E1|Reported Event|Everolimus|Daily oral Everolimus 10 mg/day
494636|NCT00770029|B3|Baseline|Total|Total of all reporting groups
494637|NCT00770029|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494638|NCT00770029|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494639|NCT00770029|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494640|NCT00770029|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494641|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494642|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494643|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494644|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494645|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494646|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494647|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494648|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494649|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494650|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494651|NCT00770029|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
494652|NCT00770029|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
494653|NCT00769860|B3|Baseline|Total|Total of all reporting groups
494654|NCT00769860|B2|Baseline|Placebo|Matched placebo pills, 100 mg TID for 4 months
494655|NCT00769860|B1|Baseline|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494656|NCT00769860|P2|Participant Flow|Placebo|Matched placebo pills, 100 mg TID for 4 months
494657|NCT00769860|P1|Participant Flow|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494675|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494676|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
494677|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494678|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
494679|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494680|NCT00769860|E2|Reported Event|Placebo|Matched placebo pills, 100 mg TID for 4 months
494681|NCT00769860|E1|Reported Event|Arimoclomol|Arimoclomol 100 mg TID for 4 months
494682|NCT00769704|B3|Baseline|Total|Total of all reporting groups
494683|NCT00769704|B2|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494684|NCT00769704|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494685|NCT00769704|P2|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494686|NCT00769704|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494687|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494688|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494689|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494690|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494691|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494692|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494693|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494694|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494713|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
494839|NCT00769119|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
494695|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494696|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494697|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494698|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494699|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494700|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494701|NCT00769704|E2|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
494702|NCT00769704|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
494703|NCT00769652|B3|Baseline|Total|Total of all reporting groups
494704|NCT00769652|B2|Baseline|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
494705|NCT00769652|B1|Baseline|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
494706|NCT00769652|P2|Participant Flow|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
494707|NCT00769652|P1|Participant Flow|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
494708|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
494709|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
494710|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
494711|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
494712|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
494714|NCT00769652|E2|Reported Event|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
494715|NCT00769652|E1|Reported Event|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
494716|NCT00769561|B3|Baseline|Total|Total of all reporting groups
494717|NCT00769561|B2|Baseline|Occlusal Splint|Dental treatment with occlusal splint
494718|NCT00769561|B1|Baseline|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494719|NCT00769561|P2|Participant Flow|Occlusal Splint|Dental treatment with occlusal splint
494720|NCT00769561|P1|Participant Flow|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494721|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494722|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494723|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494724|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494725|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494726|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494727|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494728|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494729|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494730|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494731|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494732|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494733|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494734|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494735|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
494736|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494737|NCT00769561|E2|Reported Event|Occlusal Splint|Dental treatment with occlusal splint
494738|NCT00769561|E1|Reported Event|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
494739|NCT00769314|B3|Baseline|Total|Total of all reporting groups
494740|NCT00769314|B2|Baseline|Placebo Group|muco-adhesive buccal tablet with placebo/Intent-to-Treat population
494741|NCT00769314|B1|Baseline|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet/Intent-to-Treat population
494742|NCT00769314|P2|Participant Flow|Placebo Group|muco-adhesive buccal tablet with placebo
494743|NCT00769314|P1|Participant Flow|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494744|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494745|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494746|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494747|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494748|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494749|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494750|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494751|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494752|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494753|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494754|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494755|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494756|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494757|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494758|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494759|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494760|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494761|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494762|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494763|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494764|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
494765|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494766|NCT00769314|E2|Reported Event|Placebo Group|muco-adhesive buccal tablet with placebo
494767|NCT00769314|E1|Reported Event|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
494768|NCT00769184|B1|Baseline|Corticosteroid+LCD vs Corticosteroid+Placebo|"one side of body: corticosteroid and liquor carbonis distillate (LCD) treatment applied twice a day, for 2 weeks, then LCD-only twice a day, for 4 weeks, then no treatment for 6 weeks~opposite side of body: corticosteroid and placebo vehicle solution twice a day, for 2 weeks, then placebo vehicle solution-only twice a day, for 4 weeks, then no treatment for 6 weeks"
494769|NCT00769184|P2|Participant Flow|Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)|"Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8).~On right side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On left side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
494828|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494829|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494830|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494770|NCT00769184|P1|Participant Flow|Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)|"Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7).~On left side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On right side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
494771|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo solution applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
494772|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution-only applied to one side of the body twice per day for 4 weeks.
494773|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
494774|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
494775|NCT00769184|E2|Reported Event|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
494776|NCT00769184|E1|Reported Event|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
494777|NCT00769132|B1|Baseline|Totals for Study|All participants in the study.
494778|NCT00769132|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
494779|NCT00769132|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
494780|NCT00769132|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
494781|NCT00769132|P1|Participant Flow|Sequence 1: D/C/A/B|"A = Extended Release (ER) niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
494782|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
494783|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
494784|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
494785|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
494786|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
494787|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
494788|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
494789|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
494790|NCT00769132|E4|Reported Event|Placebo|Placebo once daily for 7 days
494791|NCT00769132|E3|Reported Event|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
494792|NCT00769132|E2|Reported Event|ER Niacin 2 g|ER niacin 2 g once daily for 7 days
494793|NCT00769132|E1|Reported Event|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg once daily for 7 days
494794|NCT00769119|B3|Baseline|Total|Total of all reporting groups
494795|NCT00769119|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
494796|NCT00769119|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494797|NCT00769119|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
494798|NCT00769119|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494799|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494800|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494801|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494802|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494803|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494804|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494805|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494806|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494807|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494808|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494809|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494810|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494811|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494812|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494813|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494814|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494815|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494816|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494817|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494818|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494819|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494820|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494821|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494822|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494823|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494824|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494825|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494826|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494827|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
494840|NCT00769119|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
494841|NCT00769067|B3|Baseline|Total|Total of all reporting groups
494842|NCT00769067|B2|Baseline|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494843|NCT00769067|B1|Baseline|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494844|NCT00769067|P2|Participant Flow|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494845|NCT00769067|P1|Participant Flow|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494846|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494847|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494848|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494849|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494850|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494851|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494852|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494853|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494854|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494855|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494856|NCT00769067|O1|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494857|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494858|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494859|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494860|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494861|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494862|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494863|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494864|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494865|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494866|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494867|NCT00769067|E2|Reported Event|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494868|NCT00769067|E1|Reported Event|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
494869|NCT00769015|B3|Baseline|Total|Total of all reporting groups
494870|NCT00769015|B2|Baseline|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494871|NCT00769015|B1|Baseline|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494872|NCT00769015|P2|Participant Flow|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494916|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
518208|NCT00713661|B2|Baseline|Group 2: Open Surgery Middle/Upper|
494873|NCT00769015|P1|Participant Flow|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494874|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494875|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494876|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494877|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494878|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494879|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494880|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494881|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494882|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494883|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494884|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494917|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494885|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494886|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494887|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494888|NCT00769015|E2|Reported Event|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
494889|NCT00769015|E1|Reported Event|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
494890|NCT00768989|B3|Baseline|Total|Total of all reporting groups
494891|NCT00768989|B2|Baseline|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494892|NCT00768989|B1|Baseline|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
494893|NCT00768989|P2|Participant Flow|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494894|NCT00768989|P1|Participant Flow|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
494895|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494896|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494897|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494898|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494899|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494900|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494901|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494902|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494903|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494904|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494905|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494906|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494907|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494908|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494909|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494910|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494911|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494912|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494913|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494914|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494915|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
518209|NCT00713661|B1|Baseline|Group 1: Open Surgery Lower|
494918|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494919|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494920|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494921|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494922|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
494923|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494924|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494925|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494926|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494927|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494928|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
494929|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494930|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494931|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494932|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494933|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494934|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
494935|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494936|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494937|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
494938|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
494939|NCT00768989|E2|Reported Event|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
494940|NCT00768989|E1|Reported Event|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily
494941|NCT00768898|B1|Baseline|Overall|All enrolled participants
494942|NCT00768898|P1|Participant Flow|Overall|All enrolled participants
494943|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
494944|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
494945|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
494946|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
494947|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
494948|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
494949|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
494950|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
494951|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
494952|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
494953|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
494954|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
494955|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
494956|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
494957|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green were instilled in each eye.
494958|NCT00768898|E3|Reported Event|10.0 Microliters Lissamine Green|10.0 microliters lissamine green
494959|NCT00768898|E2|Reported Event|5.0 Microliters Lissamine Green|5.0 microliters lissamine green
494960|NCT00768898|E1|Reported Event|2.5 Microliters Lissamine Green|2.5 microliters lissamine green
494961|NCT00768755|B5|Baseline|Total|Total of all reporting groups
494962|NCT00768755|B4|Baseline|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
495041|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495478|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
494963|NCT00768755|B3|Baseline|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494964|NCT00768755|B2|Baseline|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494965|NCT00768755|B1|Baseline|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
494966|NCT00768755|P4|Participant Flow|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494967|NCT00768755|P3|Participant Flow|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494968|NCT00768755|P2|Participant Flow|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494969|NCT00768755|P1|Participant Flow|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
494970|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494971|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494972|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494973|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494974|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494975|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494976|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
495042|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495043|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
494977|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494978|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494979|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494980|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494981|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494982|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494983|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494984|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494985|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494986|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494987|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494988|NCT00768755|E4|Reported Event|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494989|NCT00768755|E3|Reported Event|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
494990|NCT00768755|E2|Reported Event|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
495044|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495045|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495046|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
494991|NCT00768755|E1|Reported Event|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
494992|NCT00768651|B1|Baseline|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
494993|NCT00768651|P1|Participant Flow|Sitagliptin + Pantoprazole|"Intervention Details:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months, followed by a three-month washout.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months, followed by a three-month washout."
494994|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
494995|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
494996|NCT00768651|E1|Reported Event|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
494997|NCT00768599|B4|Baseline|Total|Total of all reporting groups
494998|NCT00768599|B3|Baseline|Control|Vehicle Foam
494999|NCT00768599|B2|Baseline|Test Drug|Econazole Nitrate Foam 1%
495000|NCT00768599|B1|Baseline|Reference Drug|Econazole Nitrate Cream 1%
495001|NCT00768599|P3|Participant Flow|Control|Vehicle Foam
495002|NCT00768599|P2|Participant Flow|Test Drug|Econazole Nitrate Foam 1%
495003|NCT00768599|P1|Participant Flow|Reference Drug|Econazole Nitrate Cream 1%
495004|NCT00768599|O3|Outcome|Control|Vehicle Foam
495005|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
495006|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
495007|NCT00768599|O3|Outcome|Control|Vehicle Foam
495008|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
495009|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
495010|NCT00768599|O3|Outcome|Control|Vehicle Foam
495011|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
495012|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
495013|NCT00768599|O3|Outcome|Control|Vehicle Foam
495014|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
495015|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
495016|NCT00768599|O3|Outcome|Control|Vehicle Foam
495017|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
495018|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
495019|NCT00768599|O3|Outcome|Control|Vehicle Foam
495020|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
495021|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
495022|NCT00768599|E3|Reported Event|Control|Vehicle Foam
495023|NCT00768599|E2|Reported Event|Test Drug|Econazole Nitrate Foam 1%
495024|NCT00768599|E1|Reported Event|Reference Drug|Econazole Nitrate Cream 1%
495025|NCT00768560|B7|Baseline|Total|Total of all reporting groups
495026|NCT00768560|B6|Baseline|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
495027|NCT00768560|B5|Baseline|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
495028|NCT00768560|B4|Baseline|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
495029|NCT00768560|B3|Baseline|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
495030|NCT00768560|B2|Baseline|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
495031|NCT00768560|B1|Baseline|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
495032|NCT00768560|P6|Participant Flow|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
495033|NCT00768560|P5|Participant Flow|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
495034|NCT00768560|P4|Participant Flow|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
495035|NCT00768560|P3|Participant Flow|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
495036|NCT00768560|P2|Participant Flow|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
495037|NCT00768560|P1|Participant Flow|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
495038|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495039|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495040|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
495047|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495048|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495049|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
495050|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495051|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495052|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
495053|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495054|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495055|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
495056|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495057|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495058|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
495059|NCT00768560|E3|Reported Event|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
495060|NCT00768560|E2|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
495061|NCT00768560|E1|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
495062|NCT00768521|B1|Baseline|All Participants|All Study Participants from all groups.
495063|NCT00768521|P2|Participant Flow|Placebo Then Tolterodine|Placebo then Tolterodine 4 mg
495064|NCT00768521|P1|Participant Flow|Tolterodine Then Placebo|Tolterodine 4 mg then Placebo
495065|NCT00768521|O2|Outcome|Placebo|
495066|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
495067|NCT00768521|O2|Outcome|Placebo|
495068|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
495069|NCT00768521|E2|Reported Event|Placebo|
495070|NCT00768521|E1|Reported Event|Tolterodine|Tolterodine 4 mg
495071|NCT00768430|B3|Baseline|Total|Total of all reporting groups
495072|NCT00768430|B2|Baseline|Midazolam|Midazolam
495073|NCT00768430|B1|Baseline|Ketamine|Ketamine
495074|NCT00768430|P2|Participant Flow|Midazolam|single infusion of midazolam being used as an active control for the study
495075|NCT00768430|P1|Participant Flow|Ketamine|single infusion of 0.5mg/kg of Ketamine HCL
495076|NCT00768430|O2|Outcome|Midazolam|Midazolam
495077|NCT00768430|O1|Outcome|Ketamine|Ketamine
495078|NCT00768430|E2|Reported Event|Midazolam|Midazolam
495079|NCT00768430|E1|Reported Event|Ketamine|Ketamine
495080|NCT00768300|B3|Baseline|Total|Total of all reporting groups
495081|NCT00768300|B2|Baseline|Placebo|Placebo to match ambrisentan administered orally once daily
495082|NCT00768300|B1|Baseline|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495083|NCT00768300|P2|Participant Flow|Placebo|Placebo to match ambrisentan administered orally once daily
495084|NCT00768300|P1|Participant Flow|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495085|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495086|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495087|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495088|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495089|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495090|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495091|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495092|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495093|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495094|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495095|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495096|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495097|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495098|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495099|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495100|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495101|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
495102|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495103|NCT00768300|E2|Reported Event|Placebo|Placebo to match ambrisentan administered orally once daily
495104|NCT00768300|E1|Reported Event|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
495105|NCT00768222|B3|Baseline|Total|Total of all reporting groups
495479|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495106|NCT00768222|B2|Baseline|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495107|NCT00768222|B1|Baseline|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495108|NCT00768222|P2|Participant Flow|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495109|NCT00768222|P1|Participant Flow|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495110|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495111|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495112|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495113|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495114|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495115|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495116|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495117|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495118|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495119|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495120|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495121|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495122|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495123|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495124|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495125|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495126|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495127|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495128|NCT00768222|E2|Reported Event|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
495129|NCT00768222|E1|Reported Event|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
495130|NCT00768144|B1|Baseline|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
495131|NCT00768144|P1|Participant Flow|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
495132|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
495133|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
495134|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
495135|NCT00768144|E1|Reported Event|Sunitinib|Sunitinib : Taken orally once a day in the evening
495174|NCT00768066|E3|Reported Event|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495136|NCT00768118|B1|Baseline|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
495137|NCT00768118|P1|Participant Flow|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
495138|NCT00768118|O1|Outcome|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
495139|NCT00768118|E1|Reported Event|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
495140|NCT00768066|B4|Baseline|Total|Total of all reporting groups
495141|NCT00768066|B3|Baseline|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495142|NCT00768066|B2|Baseline|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495143|NCT00768066|B1|Baseline|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495144|NCT00768066|P3|Participant Flow|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495145|NCT00768066|P2|Participant Flow|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495146|NCT00768066|P1|Participant Flow|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495147|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495148|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495149|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495150|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495151|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495152|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495153|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495154|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495218|NCT00767806|P2|Participant Flow|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495155|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495156|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495157|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495158|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495159|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495160|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495161|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495162|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495163|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495164|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495165|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495166|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495167|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495168|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495169|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495170|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495171|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495172|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495173|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495582|NCT00766532|B1|Baseline|Group 1|
495175|NCT00768066|E2|Reported Event|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495176|NCT00768066|E1|Reported Event|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
495177|NCT00768053|B1|Baseline|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495178|NCT00768053|P1|Participant Flow|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495179|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495180|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495181|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495182|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495183|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495184|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495185|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495186|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495187|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495188|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495189|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495190|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495191|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495192|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495193|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495194|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495195|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495196|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495197|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495198|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495199|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495200|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495201|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495202|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495203|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495204|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495205|NCT00768053|E1|Reported Event|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
495206|NCT00768040|B3|Baseline|Total|Total of all reporting groups
495207|NCT00768040|B2|Baseline|Placebo|Matching placebo once daily for 12 weeks
495208|NCT00768040|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
495209|NCT00768040|P2|Participant Flow|Placebo|Matching placebo once daily for 12 weeks
495210|NCT00768040|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
495211|NCT00768040|O2|Outcome|Placebo|Matching placebo once daily for 12 weeks
495212|NCT00768040|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
495213|NCT00768040|E2|Reported Event|Placebo|Matching placebo once daily for 12 weeks
495214|NCT00768040|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg once daily for 12 weeks
495215|NCT00767806|B3|Baseline|Total|Total of all reporting groups
495216|NCT00767806|B2|Baseline|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495217|NCT00767806|B1|Baseline|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495666|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495219|NCT00767806|P1|Participant Flow|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495220|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495221|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495222|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495223|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495224|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495225|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495226|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495227|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495228|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495229|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495230|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495231|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495232|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495233|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495234|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495235|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495236|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495237|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495238|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495239|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495240|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495241|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495242|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495243|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495244|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495245|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495246|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495247|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495248|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495249|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495250|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495251|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495252|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495253|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495254|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495255|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495256|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495257|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495258|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495259|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495260|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495261|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495262|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495263|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495264|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495265|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495266|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495267|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495268|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495667|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495269|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495270|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495271|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495272|NCT00767806|E2|Reported Event|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
495273|NCT00767806|E1|Reported Event|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
495274|NCT00767767|B6|Baseline|Total|Total of all reporting groups
495275|NCT00767767|B5|Baseline|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
495276|NCT00767767|B4|Baseline|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
495277|NCT00767767|B3|Baseline|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
495278|NCT00767767|B2|Baseline|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
495279|NCT00767767|B1|Baseline|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
495280|NCT00767767|P5|Participant Flow|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
495281|NCT00767767|P4|Participant Flow|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
495282|NCT00767767|P3|Participant Flow|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propofol infusion for 2 hours."
495283|NCT00767767|P2|Participant Flow|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
495284|NCT00767767|P1|Participant Flow|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
495285|NCT00767767|O5|Outcome|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
495286|NCT00767767|O4|Outcome|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
495287|NCT00767767|O3|Outcome|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
495288|NCT00767767|O2|Outcome|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
495289|NCT00767767|O1|Outcome|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
495290|NCT00767767|E5|Reported Event|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental 3mcg/mL infusion for 2 hours"
495291|NCT00767767|E4|Reported Event|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental 1.5mcg/mL infusion for 2 hours"
495292|NCT00767767|E3|Reported Event|Propofol 0.90mcg/mL|"Anesthetic Drug Infusion~Propofol 0.90mcg/mL: IV Propofol infusion for 2 hours."
495293|NCT00767767|E2|Reported Event|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
495294|NCT00767767|E1|Reported Event|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
495295|NCT00767676|B1|Baseline|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
495296|NCT00767676|P1|Participant Flow|HP828-101|HP828-101 : Nine topical patch applications, each the approximate size of a nickel, over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
495297|NCT00767676|O1|Outcome|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
495298|NCT00767676|E1|Reported Event|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
495299|NCT00767624|B3|Baseline|Total|Total of all reporting groups
495300|NCT00767624|B2|Baseline|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
495301|NCT00767624|B1|Baseline|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
495302|NCT00767624|P2|Participant Flow|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
495303|NCT00767624|P1|Participant Flow|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
495304|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
495305|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
495306|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
495307|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
495345|NCT00767507|B1|Baseline|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495308|NCT00767624|E2|Reported Event|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
495309|NCT00767624|E1|Reported Event|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
495310|NCT00767572|B1|Baseline|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.
495311|NCT00767572|P1|Participant Flow|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.
495312|NCT00767572|O2|Outcome|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
495313|NCT00767572|O1|Outcome|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks.
495314|NCT00767572|E2|Reported Event|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
495315|NCT00767572|E1|Reported Event|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
495316|NCT00767520|B3|Baseline|Total|Total of all reporting groups
495317|NCT00767520|B2|Baseline|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495318|NCT00767520|B1|Baseline|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495319|NCT00767520|P2|Participant Flow|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495320|NCT00767520|P1|Participant Flow|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495321|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495322|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495323|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495324|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495325|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495326|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495327|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495328|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495329|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495330|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495331|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495332|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495333|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495334|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495335|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495336|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495337|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495338|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495339|NCT00767520|E2|Reported Event|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
495340|NCT00767520|E1|Reported Event|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
495341|NCT00767507|B5|Baseline|Total|Total of all reporting groups
495342|NCT00767507|B4|Baseline|Stage II Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495343|NCT00767507|B3|Baseline|Stage II Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495344|NCT00767507|B2|Baseline|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495668|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495346|NCT00767507|P4|Participant Flow|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495347|NCT00767507|P3|Participant Flow|Stage II - Cangrelor Arm (0.75 mcg/kg/Min )|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495348|NCT00767507|P2|Participant Flow|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495349|NCT00767507|P1|Participant Flow|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495350|NCT00767507|O4|Outcome|Stage I - Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495351|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor (0.5 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495352|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495353|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495354|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495355|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495356|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495357|NCT00767507|O1|Outcome|Stage II - Cangrelor (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495358|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495359|NCT00767507|O3|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495360|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495361|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495362|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495363|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495364|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received m as a matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495365|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495366|NCT00767507|O2|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495367|NCT00767507|O1|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495368|NCT00767507|E4|Reported Event|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495369|NCT00767507|E3|Reported Event|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495370|NCT00767507|E2|Reported Event|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495371|NCT00767507|E1|Reported Event|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
495372|NCT00767455|B1|Baseline|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
495373|NCT00767455|P1|Participant Flow|HP828-101 vs. Negative Control vs. Positive Control|Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
495374|NCT00767455|O3|Outcome|Positive Control|Sodium Lauryl Sulfate
495375|NCT00767455|O2|Outcome|Negative Control|Johnson's Baby Oil
495376|NCT00767455|O1|Outcome|HP828-101|Intervention test article
495377|NCT00767455|E1|Reported Event|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
495378|NCT00767364|B3|Baseline|Total|Total of all reporting groups
495379|NCT00767364|B2|Baseline|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495380|NCT00767364|B1|Baseline|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495476|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495669|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495381|NCT00767364|P2|Participant Flow|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495382|NCT00767364|P1|Participant Flow|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495383|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495384|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495385|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495386|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495387|NCT00767364|E2|Reported Event|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495388|NCT00767364|E1|Reported Event|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
495389|NCT00767338|B5|Baseline|Total|Total of all reporting groups
495390|NCT00767338|B4|Baseline|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495391|NCT00767338|B3|Baseline|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495392|NCT00767338|B2|Baseline|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495393|NCT00767338|B1|Baseline|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495394|NCT00767338|P4|Participant Flow|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495395|NCT00767338|P3|Participant Flow|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495396|NCT00767338|P2|Participant Flow|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495397|NCT00767338|P1|Participant Flow|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495398|NCT00767338|O4|Outcome|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495399|NCT00767338|O3|Outcome|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495400|NCT00767338|O2|Outcome|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495401|NCT00767338|O1|Outcome|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495402|NCT00767338|E4|Reported Event|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495403|NCT00767338|E3|Reported Event|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495404|NCT00767338|E2|Reported Event|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
495405|NCT00767338|E1|Reported Event|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
495406|NCT00767325|B1|Baseline|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495407|NCT00767325|P1|Participant Flow|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495408|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495409|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495410|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495411|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495412|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495413|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
495414|NCT00767325|E1|Reported Event|Aba 10 mg/kg|
495415|NCT00767104|B3|Baseline|Total|Total of all reporting groups
495416|NCT00767104|B2|Baseline|Control Pillowcase|placebo pillowcase made of 100% cotton
495417|NCT00767104|B1|Baseline|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
495418|NCT00767104|P2|Participant Flow|Control Pillowcase|placebo pillowcase made of 100% cotton
495419|NCT00767104|P1|Participant Flow|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
495420|NCT00767104|O2|Outcome|Control Pillowcase|placebo pillowcase made of 100% cotton
495421|NCT00767104|O1|Outcome|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
495422|NCT00767104|O2|Outcome|Control Cotton Pillowcase|placebo pillowcase made of 100% cotton
495423|NCT00767104|O1|Outcome|Experimental Silk-like Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
495424|NCT00767104|E2|Reported Event|Control Pillowcase|placebo pillowcase made of 100% cotton
495425|NCT00767104|E1|Reported Event|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
495426|NCT00767039|B3|Baseline|Total|Total of all reporting groups
495427|NCT00767039|B2|Baseline|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495428|NCT00767039|B1|Baseline|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495429|NCT00767039|P2|Participant Flow|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495430|NCT00767039|P1|Participant Flow|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495431|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495432|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495433|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495434|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495435|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495436|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495437|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495477|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495438|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495439|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495440|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495441|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495442|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495443|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495444|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495445|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495446|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495447|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495448|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495449|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495450|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495451|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495452|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495453|NCT00767039|E2|Reported Event|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
495454|NCT00767039|E1|Reported Event|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
495455|NCT00767000|B6|Baseline|Total|Total of all reporting groups
495456|NCT00767000|B5|Baseline|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495457|NCT00767000|B4|Baseline|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495458|NCT00767000|B3|Baseline|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495459|NCT00767000|B2|Baseline|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495460|NCT00767000|B1|Baseline|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495461|NCT00767000|P5|Participant Flow|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495462|NCT00767000|P4|Participant Flow|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495463|NCT00767000|P3|Participant Flow|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495464|NCT00767000|P2|Participant Flow|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495465|NCT00767000|P1|Participant Flow|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495466|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495467|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495468|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495469|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495470|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495471|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495472|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495473|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495474|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495475|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495670|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495480|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495481|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495482|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495483|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495484|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495485|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495486|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495487|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495488|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495489|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495490|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495491|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495492|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495493|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495494|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495495|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495496|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495497|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495498|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495499|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495500|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495501|NCT00767000|E5|Reported Event|Placebo|Placebo three times daily plus insulin once daily with or without metformin
495502|NCT00767000|E4|Reported Event|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
495503|NCT00767000|E3|Reported Event|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
495504|NCT00767000|E2|Reported Event|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
495505|NCT00767000|E1|Reported Event|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
495506|NCT00766831|B1|Baseline|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495507|NCT00766831|P1|Participant Flow|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495508|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495509|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495510|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495511|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495512|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495513|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495514|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495515|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495516|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495517|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495518|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495519|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495520|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495521|NCT00766831|E1|Reported Event|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
495522|NCT00766753|B3|Baseline|Total|Total of all reporting groups
495523|NCT00766753|B2|Baseline|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495524|NCT00766753|B1|Baseline|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495525|NCT00766753|P2|Participant Flow|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495526|NCT00766753|P1|Participant Flow|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495527|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495528|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495529|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495530|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495531|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495671|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495532|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495533|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495534|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
495535|NCT00766753|E1|Reported Event|Alpha DC1 Vaccine + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine, up to 4 vaccines
495536|NCT00766675|B1|Baseline|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495537|NCT00766675|P1|Participant Flow|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495538|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495539|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495540|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495541|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495542|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495543|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495544|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495545|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495546|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495547|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495548|NCT00766675|E1|Reported Event|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
495549|NCT00766649|B1|Baseline|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495550|NCT00766649|P1|Participant Flow|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495551|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495552|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495553|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495554|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495555|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495556|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495557|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495558|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495559|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495560|NCT00766649|E1|Reported Event|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
495561|NCT00766636|B3|Baseline|Total|Total of all reporting groups
495562|NCT00766636|B2|Baseline|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
495563|NCT00766636|B1|Baseline|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
495564|NCT00766636|P2|Participant Flow|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
495565|NCT00766636|P1|Participant Flow|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
495566|NCT00766636|O2|Outcome|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
495567|NCT00766636|O1|Outcome|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
495568|NCT00766636|E2|Reported Event|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
495569|NCT00766636|E1|Reported Event|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
495570|NCT00766597|B1|Baseline|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495571|NCT00766597|P1|Participant Flow|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495572|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495573|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495574|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495575|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495576|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495577|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495578|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495579|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
495580|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic virus
495581|NCT00766597|E1|Reported Event|Vicriviroc in Tablet Form (20/30mg) or Liquid Form (1mg/ml)|Drug: Vicriviroc Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
495583|NCT00766532|P1|Participant Flow|Arm Title- Aromatase Inhibitor Therapy|calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.
495584|NCT00766532|O1|Outcome|Aromatase Inhibitor Therapy|
495585|NCT00766532|E1|Reported Event|Group 1|
495586|NCT00766506|B3|Baseline|Total|Total of all reporting groups
495587|NCT00766506|B2|Baseline|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495588|NCT00766506|B1|Baseline|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495589|NCT00766506|P2|Participant Flow|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495590|NCT00766506|P1|Participant Flow|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495591|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495592|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495593|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495594|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495595|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495596|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495597|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495598|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495599|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495600|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495601|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495602|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495603|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495604|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495605|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495672|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495673|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495674|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495606|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495607|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495608|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495609|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495610|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495611|NCT00766506|E2|Reported Event|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
495612|NCT00766506|E1|Reported Event|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
495613|NCT00766493|B1|Baseline|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495614|NCT00766493|P1|Participant Flow|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495615|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495616|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495617|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495618|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495619|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495620|NCT00766493|E1|Reported Event|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
495621|NCT00766467|B3|Baseline|Total|Total of all reporting groups
495622|NCT00766467|B2|Baseline|Placebo|Placebo: Taken orally once a day in the morning.
495623|NCT00766467|B1|Baseline|Armodafinil|Armodafinil: Taken orally once a day in the morning.
495624|NCT00766467|P2|Participant Flow|Placebo|Placebo: Taken orally once a day in the morning
495625|NCT00766467|P1|Participant Flow|Armodafinil|Armodafinil: 150mg taken orally once a day in the morning.
495626|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
495627|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
495628|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
495629|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
495630|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
495631|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
495632|NCT00766467|E2|Reported Event|Placebo|Placebo: Taken orally once a day in the morning.
495633|NCT00766467|E1|Reported Event|Armodafinil|Armodafinil: Taken orally once a day in the morning.
495634|NCT00766415|B3|Baseline|Total|Total of all reporting groups
495635|NCT00766415|B2|Baseline|Placebo|Placebo, twice daily
495636|NCT00766415|B1|Baseline|AZD1981|AZD1981 1000 mg, twice daily
495637|NCT00766415|P2|Participant Flow|Placebo|Placebo, twice daily
495638|NCT00766415|P1|Participant Flow|AZD1981|AZD1981 1000 mg, twice daily
495639|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495640|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495641|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495642|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495643|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495644|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495645|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495646|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495647|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495648|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495649|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495650|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495651|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495652|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495653|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495654|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495655|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495656|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495657|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495658|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495659|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495660|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495661|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495662|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495663|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495664|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
495665|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
495685|NCT00766376|B1|Baseline|Erbium Laser|Each subject will undergo a minimum of 1 treatment with 5 scheduled follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
495686|NCT00766376|P1|Participant Flow|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
495687|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
495688|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
495689|NCT00766376|E1|Reported Event|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
495690|NCT00766363|B5|Baseline|Total|Total of all reporting groups
495691|NCT00766363|B4|Baseline|Placebo|1 capsule per day for 28 days.
495692|NCT00766363|B3|Baseline|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495693|NCT00766363|B2|Baseline|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495694|NCT00766363|B1|Baseline|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495695|NCT00766363|P4|Participant Flow|Placebo|1 capsule per day for 28 days.
495696|NCT00766363|P3|Participant Flow|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495697|NCT00766363|P2|Participant Flow|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495698|NCT00766363|P1|Participant Flow|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495699|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495700|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495701|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495702|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495703|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495704|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495705|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
495706|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495707|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495708|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495709|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
495710|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495711|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495712|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495713|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
495714|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495715|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495716|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495717|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495718|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495719|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495720|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495721|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495722|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495723|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495724|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495725|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495726|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
495727|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495728|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495729|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495730|NCT00766363|E4|Reported Event|Placebo|1 capsule per day for 28 days.
495731|NCT00766363|E3|Reported Event|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
495732|NCT00766363|E2|Reported Event|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
495733|NCT00766363|E1|Reported Event|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
495734|NCT00766090|B3|Baseline|Total|Total of all reporting groups
495735|NCT00766090|B2|Baseline|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495736|NCT00766090|B1|Baseline|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495822|NCT00765882|P2|Participant Flow|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495737|NCT00766090|P12|Participant Flow|Sequence 12: FP 200 µg, FP 100 µg, Placebo|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495738|NCT00766090|P11|Participant Flow|Sequence 11: FP 200 µg, Placebo, FP 100 µg|Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495739|NCT00766090|P10|Participant Flow|Sequence 10: FP 100 µg, FP 200 µg, Placebo|Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495740|NCT00766090|P9|Participant Flow|Sequence 9: FP 100 µg, Placebo, FP 200 µg|Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495741|NCT00766090|P8|Participant Flow|Sequence 8: Placebo, FP 100 µg, FP 200 µg|Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495742|NCT00766090|P7|Participant Flow|Sequence 7: Placebo, FP 200 µg, FP 100 µg|Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495743|NCT00766090|P6|Participant Flow|Sequence 6: FF 200 µg, FF 100 µg, Placebo|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495744|NCT00766090|P5|Participant Flow|Sequence 5: FF 200 µg, Placebo, FF 100 µg|Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495745|NCT00766090|P4|Participant Flow|Sequence 4: FF 100 µg, FF 200 µg, Placebo|Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495746|NCT00766090|P3|Participant Flow|Sequence 3: FF 100 µg, Placebo, FF 200 µg|Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495747|NCT00766090|P2|Participant Flow|Sequence 2: Placebo, FF 100 µg, FF 200 µg|Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495748|NCT00766090|P1|Participant Flow|Sequence 1: Placebo, FF 200 µg, FF 100 µg|Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495749|NCT00766090|O2|Outcome|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495750|NCT00766090|O1|Outcome|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495823|NCT00765882|P1|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day.
495751|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495752|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495753|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495754|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495755|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495756|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495757|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495758|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495759|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495760|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495761|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495762|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495763|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495764|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495765|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495766|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495767|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495768|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495769|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495770|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495987|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
495771|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495772|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495773|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495774|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495775|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495776|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495777|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495778|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495779|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495780|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495781|NCT00766090|E5|Reported Event|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495782|NCT00766090|E4|Reported Event|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495783|NCT00766090|E3|Reported Event|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495784|NCT00766090|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495785|NCT00766090|E1|Reported Event|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
495786|NCT00766051|B3|Baseline|Total|Total of all reporting groups
495787|NCT00766051|B2|Baseline|Intervention Group|This is the only Matched Historical Comparison group infants that the analysis refer to. The intervention group consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
495788|NCT00766051|B1|Baseline|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee (1978) and consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
495789|NCT00766051|P2|Participant Flow|Matched Historical Comparison Group|Matched Historical Controls drawn from a three year period.
495790|NCT00766051|P1|Participant Flow|Intervention Group|This is the only intervention group that the analysis apply to.
495791|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
495792|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
495793|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
495824|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495794|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
495795|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
495796|NCT00766051|O2|Outcome|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee, (1978).
495797|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to. The intervention and the matched historical comparison group consisted of preterm, near term and full term infants with feeding problems.
495798|NCT00766051|E1|Reported Event|Intervention Group|This is the only intervention group that the analysis apply to.
495799|NCT00765947|B1|Baseline|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
495800|NCT00765947|P1|Participant Flow|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
495801|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
495802|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
495803|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
495804|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
495805|NCT00765947|E3|Reported Event|Aliskiren + HCTZ + Amlodipine|Aliskiren + HCTZ + Amlodipine treatment step
495806|NCT00765947|E2|Reported Event|Aliskiren + HCTZ|Aliskiren and HCTZ treatment step
495807|NCT00765947|E1|Reported Event|Aliskiren|Aliskiren treatment step
495808|NCT00765895|B3|Baseline|Total|Total of all reporting groups
495809|NCT00765895|B2|Baseline|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495810|NCT00765895|B1|Baseline|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495811|NCT00765895|P2|Participant Flow|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495812|NCT00765895|P1|Participant Flow|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495813|NCT00765895|O2|Outcome|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495814|NCT00765895|O1|Outcome|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495815|NCT00765895|E2|Reported Event|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495816|NCT00765895|E1|Reported Event|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
495817|NCT00765882|B4|Baseline|Total|Total of all reporting groups
495818|NCT00765882|B3|Baseline|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495819|NCT00765882|B2|Baseline|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495820|NCT00765882|B1|Baseline|Placebo|Dose matched placebo, oral administration, once per day.
495821|NCT00765882|P3|Participant Flow|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495825|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495826|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495827|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495828|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495829|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495830|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495831|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495832|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495833|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495834|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495835|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495836|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495837|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495838|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495839|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495840|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495841|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495842|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495843|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495844|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495845|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495846|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495847|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
495848|NCT00765882|E3|Reported Event|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
495849|NCT00765882|E2|Reported Event|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
495850|NCT00765882|E1|Reported Event|Placebo|Dose matched placebo, oral administration, once per day.
495851|NCT00765843|B4|Baseline|Total|Total of all reporting groups
495852|NCT00765843|B3|Baseline|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495853|NCT00765843|B2|Baseline|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495854|NCT00765843|B1|Baseline|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495855|NCT00765843|P3|Participant Flow|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495856|NCT00765843|P2|Participant Flow|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495857|NCT00765843|P1|Participant Flow|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495858|NCT00765843|O3|Outcome|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495859|NCT00765843|O2|Outcome|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495860|NCT00765843|O1|Outcome|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495861|NCT00765843|E3|Reported Event|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495862|NCT00765843|E2|Reported Event|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495863|NCT00765843|E1|Reported Event|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
495865|NCT00765817|B2|Baseline|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495866|NCT00765817|B1|Baseline|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495867|NCT00765817|P2|Participant Flow|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495868|NCT00765817|P1|Participant Flow|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495869|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495870|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495871|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495872|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495873|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495874|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495875|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495876|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495877|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495878|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495879|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495880|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495881|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495882|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495883|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495884|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495885|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495886|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495887|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495888|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495889|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495890|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495891|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495892|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495893|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495894|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495895|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495896|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495897|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
523862|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
495898|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495899|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495900|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495901|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495902|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495903|NCT00765817|E2|Reported Event|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
495904|NCT00765817|E1|Reported Event|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
495905|NCT00765765|B1|Baseline|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495906|NCT00765765|P1|Participant Flow|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495907|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495908|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495909|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495910|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495911|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495912|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495913|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495914|NCT00765765|E1|Reported Event|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
495915|NCT00765726|B1|Baseline|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
495916|NCT00765726|P1|Participant Flow|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
495917|NCT00765726|O1|Outcome|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
495918|NCT00765726|E1|Reported Event|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
495919|NCT00765674|B5|Baseline|Total|Total of all reporting groups
495920|NCT00765674|B4|Baseline|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495921|NCT00765674|B3|Baseline|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495922|NCT00765674|B2|Baseline|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495923|NCT00765674|B1|Baseline|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
497276|NCT00762788|P4|Participant Flow|Balafilcon A Contact Lens|PureVision
495924|NCT00765674|P4|Participant Flow|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495925|NCT00765674|P3|Participant Flow|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495926|NCT00765674|P2|Participant Flow|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495927|NCT00765674|P1|Participant Flow|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495928|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495929|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495930|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495931|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495932|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495933|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495934|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495935|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
496119|NCT00765076|P2|Participant Flow|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
495936|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495937|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495938|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495939|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495940|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495941|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495942|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495943|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495944|NCT00765674|E4|Reported Event|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495945|NCT00765674|E3|Reported Event|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
495946|NCT00765674|E2|Reported Event|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495947|NCT00765674|E1|Reported Event|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
495948|NCT00765661|B3|Baseline|Total|Total of all reporting groups
497277|NCT00762788|P3|Participant Flow|Lotrafilcon B Contact Lens|O2Optix
495949|NCT00765661|B2|Baseline|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily, orally"
495950|NCT00765661|B1|Baseline|Gorup A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets, orally"
495951|NCT00765661|P2|Participant Flow|Group B|Randomized, parallel-group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of Prograf capsules in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive Prograf capsules in 2 equally divided doses, starting at 0.1 mg/kg every 12 hours (0.2 mg/kg total daily dose) as recommended in the U.S. Prescribing Information
495952|NCT00765661|P1|Participant Flow|Group A|Randomized, parallel group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive LCP-Tacro tablets orally once daily (QD) in the morning, with an interval of 24 +/-1 hours between doses, starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg)
495953|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
495954|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
495955|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
495956|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
495957|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
495958|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
495959|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
495960|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
495961|NCT00765661|E2|Reported Event|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily"
495962|NCT00765661|E1|Reported Event|Group A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets"
495963|NCT00765648|B3|Baseline|Total|Total of all reporting groups
495964|NCT00765648|B2|Baseline|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
495965|NCT00765648|B1|Baseline|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
495966|NCT00765648|P2|Participant Flow|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
495967|NCT00765648|P1|Participant Flow|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
495968|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
495969|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
495970|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
495971|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
495972|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
495973|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
495974|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
495975|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
495976|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
495977|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
495978|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
495979|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
495980|NCT00765648|E2|Reported Event|Labetalol|Bolus Labetalol began at 20 mg over 2 minutes
495981|NCT00765648|E1|Reported Event|Nicardipine|Nicardipine dosing was 5 mg/hour
495982|NCT00765570|B3|Baseline|Total|Total of all reporting groups
495983|NCT00765570|B2|Baseline|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
495984|NCT00765570|B1|Baseline|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
495985|NCT00765570|P2|Participant Flow|Treatment Group-2|Treatment Group 2:15 treatments with standard radiation
495986|NCT00765570|P1|Participant Flow|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
495988|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
495989|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
495990|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
495991|NCT00765570|E2|Reported Event|Treatment Group-2|Treatment Group 2-15 treatments with standard radiation
495992|NCT00765570|E1|Reported Event|Treatment Group 1|Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
495993|NCT00765388|B1|Baseline|Entire Study Population|Includes groups randomized to receive SenSura Uro first and Hollister Uro first
495994|NCT00765388|P2|Participant Flow|SenSura Uro First, Then Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
495995|NCT00765388|P1|Participant Flow|Hollister Uro First, Then SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
495996|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
495997|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
495998|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
495999|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496000|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496001|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496002|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496003|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496004|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496005|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496006|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496007|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496008|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496009|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496010|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496011|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496012|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496013|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496014|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496015|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496016|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496017|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496018|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496019|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496020|NCT00765388|E2|Reported Event|SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496021|NCT00765388|E1|Reported Event|Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
496022|NCT00765375|B1|Baseline|Active on One Side and Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face.
496023|NCT00765375|P1|Participant Flow|Active on One Side, Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) treatment on one side of the face and bacteriostatic saline solution (Placebo) on the other side of the face.
496024|NCT00765375|O2|Outcome|2- Placebo|Saline Solution
496025|NCT00765375|O1|Outcome|1- Active|Botulinum Neurotoxin Type A (Botox)
496026|NCT00765375|E2|Reported Event|2- Placebo|Saline Solution
496027|NCT00765375|E1|Reported Event|1- Active|Botulinum Neurotoxin Type A (Botox)
496028|NCT00765362|B1|Baseline|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
496089|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496090|NCT00765128|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496121|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496029|NCT00765362|P1|Participant Flow|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
496030|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
496031|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
496032|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
496033|NCT00765362|E1|Reported Event|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
496034|NCT00765336|B3|Baseline|Total|Total of all reporting groups
496035|NCT00765336|B2|Baseline|Placebo|daily dose of Placebo
496036|NCT00765336|B1|Baseline|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
496037|NCT00765336|P2|Participant Flow|Placebo|daily dose of Placebo
496038|NCT00765336|P1|Participant Flow|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
496039|NCT00765336|O2|Outcome|Placebo|daily dose of Placebo
496040|NCT00765336|O1|Outcome|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
496041|NCT00765336|E2|Reported Event|Placebo|daily dose of Placebo
496042|NCT00765336|E1|Reported Event|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
496043|NCT00765245|B3|Baseline|Total|Total of all reporting groups
496044|NCT00765245|B2|Baseline|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
496045|NCT00765245|B1|Baseline|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
496046|NCT00765245|P2|Participant Flow|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
496047|NCT00765245|P1|Participant Flow|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
496048|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
496049|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
496050|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
496051|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
496091|NCT00765128|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496120|NCT00765076|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496052|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
496053|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
496054|NCT00765245|E2|Reported Event|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
496055|NCT00765245|E1|Reported Event|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
496056|NCT00765232|B3|Baseline|Total|Total of all reporting groups
496057|NCT00765232|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496058|NCT00765232|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496059|NCT00765232|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496060|NCT00765232|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496061|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496062|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496063|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496064|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496065|NCT00765232|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496066|NCT00765232|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496067|NCT00765206|B1|Baseline|Entire Study Population|
496068|NCT00765206|P4|Participant Flow|Prilosec First, Then Zegerid (7-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
496069|NCT00765206|P3|Participant Flow|Zegerid First, Then Prilosec ( 7-Day Dosing)|Participants received Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
496070|NCT00765206|P2|Participant Flow|Prilosec First, Then Zegerid (1-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
496071|NCT00765206|P1|Participant Flow|Zegerid First, Then Prilosec (1- Day Dosing)|Participants received Zegerid Over-the-counter (OTC) Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
496072|NCT00765206|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
496073|NCT00765206|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
496074|NCT00765206|E2|Reported Event|Prilosec|Subjects who received a single dose of Prilosec per day for either 1 or 7 days.
496075|NCT00765206|E1|Reported Event|Zegerid|Subjects who received a single dose of Zegerid per day for either 1 or 7 days.
496076|NCT00765193|B1|Baseline|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
496077|NCT00765193|P1|Participant Flow|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
496078|NCT00765193|O2|Outcome|Full Body Examination|
496079|NCT00765193|O1|Outcome|Problem Area Examination|
496080|NCT00765193|E1|Reported Event|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
496081|NCT00765128|B3|Baseline|Total|Total of all reporting groups
496082|NCT00765128|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496083|NCT00765128|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496084|NCT00765128|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496085|NCT00765128|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496086|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496087|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
496088|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
523863|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
496092|NCT00765102|B1|Baseline|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496093|NCT00765102|P1|Participant Flow|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496094|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496095|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496096|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496097|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496098|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496099|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
496100|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
496101|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
496102|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
496103|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
496104|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
496105|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
496106|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
496107|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
496108|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
496109|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
496110|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
496111|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496112|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496113|NCT00765102|E1|Reported Event|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
496114|NCT00765076|B4|Baseline|Total|Total of all reporting groups
496115|NCT00765076|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496116|NCT00765076|B2|Baseline|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496117|NCT00765076|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496118|NCT00765076|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
497278|NCT00762788|P2|Participant Flow|Lotrafilcon A Contact Lens|NIGHT&DAY
496122|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496123|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496124|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496125|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496126|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496127|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496128|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496129|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496130|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496131|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496132|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496133|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496134|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496135|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496136|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496137|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496138|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496139|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496140|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496141|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496142|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496143|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496144|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496145|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496146|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496147|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496148|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496149|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496150|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496151|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496152|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496153|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496154|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496155|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496156|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496157|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496158|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496159|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496160|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496161|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496162|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496163|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496164|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496165|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496166|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496167|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496168|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496169|NCT00765076|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
496170|NCT00765076|E2|Reported Event|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
496171|NCT00765076|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
496172|NCT00765063|B1|Baseline|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496173|NCT00765063|P1|Participant Flow|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496174|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496175|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496176|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496177|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496178|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496179|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496180|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496181|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496182|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496183|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496184|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496185|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496186|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496187|NCT00765063|E1|Reported Event|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
496188|NCT00765037|B1|Baseline|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
496189|NCT00765037|P1|Participant Flow|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
496190|NCT00765037|O1|Outcome|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
496191|NCT00765037|E1|Reported Event|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
496192|NCT00764946|B4|Baseline|Total|Total of all reporting groups
496193|NCT00764946|B3|Baseline|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496194|NCT00764946|B2|Baseline|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496195|NCT00764946|B1|Baseline|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496196|NCT00764946|P3|Participant Flow|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496197|NCT00764946|P2|Participant Flow|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496198|NCT00764946|P1|Participant Flow|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
496199|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496200|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496201|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496202|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496203|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496204|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496205|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496206|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496207|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496208|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496209|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496210|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496211|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496212|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496213|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496214|NCT00764946|O3|Outcome|Treatment Naive|
496215|NCT00764946|O2|Outcome|Treatment-Experienced - Treatment Intolerant|
496216|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|
496217|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496218|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496219|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496220|NCT00764946|E3|Reported Event|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496221|NCT00764946|E2|Reported Event|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496222|NCT00764946|E1|Reported Event|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
496223|NCT00764881|B3|Baseline|Total|Total of all reporting groups
496224|NCT00764881|B2|Baseline|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496225|NCT00764881|B1|Baseline|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496226|NCT00764881|P2|Participant Flow|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496227|NCT00764881|P1|Participant Flow|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496228|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496229|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496230|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496231|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523864|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
496232|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496233|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496234|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496235|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496236|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496237|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496238|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496239|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496240|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496241|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496242|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496243|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496244|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496245|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496246|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496247|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496248|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496249|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496250|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496251|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496252|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496253|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496254|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496255|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496256|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496257|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496258|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496259|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523865|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
496260|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496261|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496262|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496263|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496264|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496265|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496266|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496267|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496268|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496269|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496270|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496271|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496272|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496273|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496274|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496275|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496276|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496277|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496278|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496279|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496280|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496281|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496282|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496283|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496284|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496285|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496286|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496287|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523866|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
496288|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496289|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496290|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496291|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496292|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496293|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496294|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496295|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496296|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496297|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496298|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496299|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496300|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496301|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496302|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496303|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496304|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496305|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496306|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496307|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496308|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496309|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496310|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496311|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496312|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496313|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496314|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496315|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523867|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
496316|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496317|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496318|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496319|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496320|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496321|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496322|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496323|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496324|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496325|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496326|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496327|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496328|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496329|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496330|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496331|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496332|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496333|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496334|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496335|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496336|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496337|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496338|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496339|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496340|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496341|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496342|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496343|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523868|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
496344|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496345|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496346|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496347|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496348|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496349|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496350|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496351|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496352|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496353|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496354|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496355|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496356|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496357|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496358|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496359|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496360|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496361|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496362|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496363|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496364|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496365|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496366|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496367|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496368|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496369|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496370|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496371|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523869|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
496372|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496373|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496374|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496375|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496376|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496377|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496378|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496379|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496380|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496381|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496382|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496383|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496384|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496385|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496386|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496387|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496388|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496389|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496390|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496391|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496392|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496393|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496394|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496395|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496396|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496397|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496398|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496399|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523870|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
496400|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496401|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496402|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496403|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496404|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496405|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496406|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496407|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496408|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496409|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496410|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496411|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496412|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496413|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496414|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496415|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496416|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496417|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496418|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496419|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496420|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496421|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496422|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496423|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496424|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496425|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496426|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496427|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
523871|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
496428|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496429|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496430|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496431|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496432|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496433|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496434|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496435|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496436|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496437|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496438|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496439|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496440|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496441|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496442|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496443|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496444|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496445|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496446|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
496447|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
496448|NCT00764881|E2|Reported Event|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles
496449|NCT00764881|E1|Reported Event|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles
496450|NCT00764868|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
496451|NCT00764868|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
496452|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
496453|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
496454|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
496535|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496455|NCT00764868|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
496456|NCT00764790|B4|Baseline|Total|Total of all reporting groups
496457|NCT00764790|B3|Baseline|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496458|NCT00764790|B2|Baseline|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496459|NCT00764790|B1|Baseline|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496460|NCT00764790|P3|Participant Flow|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496461|NCT00764790|P2|Participant Flow|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496462|NCT00764790|P1|Participant Flow|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496463|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496464|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496465|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496466|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496467|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496468|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496469|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496470|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496471|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496472|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496473|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496536|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496537|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496474|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496475|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496476|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496477|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496478|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496479|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496480|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496481|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496482|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496483|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496484|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496485|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496486|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496487|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496488|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496489|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496490|NCT00764790|E3|Reported Event|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496491|NCT00764790|E2|Reported Event|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496538|NCT00764660|E2|Reported Event|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496539|NCT00764660|E1|Reported Event|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496492|NCT00764790|E1|Reported Event|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
496493|NCT00764699|B1|Baseline|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
496494|NCT00764699|P1|Participant Flow|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
496495|NCT00764699|O1|Outcome|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
496496|NCT00764699|E1|Reported Event|rhIGF|"Treatment with rhIGF (Increlex)~rhIGF (Increlex): rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID."
496497|NCT00764673|B1|Baseline|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496498|NCT00764673|P1|Participant Flow|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496499|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496500|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496501|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496502|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496503|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496504|NCT00764673|E1|Reported Event|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
496505|NCT00764660|B3|Baseline|Total|Total of all reporting groups
496506|NCT00764660|B2|Baseline|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496507|NCT00764660|B1|Baseline|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496508|NCT00764660|P2|Participant Flow|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496509|NCT00764660|P1|Participant Flow|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496510|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496511|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496512|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496513|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496514|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496515|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496516|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496517|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496518|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496519|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496520|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496521|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496522|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496523|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496524|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496525|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496526|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496527|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496528|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496529|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496530|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496531|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496532|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496533|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
496534|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
496541|NCT00764517|B2|Baseline|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496542|NCT00764517|B1|Baseline|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496543|NCT00764517|P2|Participant Flow|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496544|NCT00764517|P1|Participant Flow|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496545|NCT00764517|O2|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496546|NCT00764517|O1|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496547|NCT00764517|O2|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496548|NCT00764517|O1|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496549|NCT00764517|O2|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496550|NCT00764517|O1|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496551|NCT00764517|O2|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496552|NCT00764517|O1|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496553|NCT00764517|O2|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496554|NCT00764517|O1|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496555|NCT00764517|O2|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496556|NCT00764517|O1|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496557|NCT00764517|O2|Outcome|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496558|NCT00764517|O1|Outcome|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496559|NCT00764517|E2|Reported Event|Relapsed|"Patients with relapsed disease including indolent Non-Hodgkins Lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL) [Group II].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496560|NCT00764517|E1|Reported Event|Previously Untreated|"Patients enrolled with untreated, newly diagnosed mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) [Group I].~Patients receive 400 mg vorinostat PO on days 1-14, 5 mg/m^2 cladribine IV over 2 hours on days 1-5, and 375 mg/m^2 rituximab IV on day 3 (weekly for the first course). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity."
496561|NCT00764504|B4|Baseline|Total|Total of all reporting groups
496562|NCT00764504|B3|Baseline|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496563|NCT00764504|B2|Baseline|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496564|NCT00764504|B1|Baseline|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496565|NCT00764504|P3|Participant Flow|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496566|NCT00764504|P2|Participant Flow|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496567|NCT00764504|P1|Participant Flow|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496568|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496569|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496570|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496571|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496572|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496573|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496574|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496575|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496576|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496577|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496578|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496579|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496580|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
497279|NCT00762788|P1|Participant Flow|Senofilcon A Contact Lens|ACUVUE OASYS
496581|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496582|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496583|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496584|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496585|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496586|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496587|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496588|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496589|NCT00764504|E3|Reported Event|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
496590|NCT00764504|E2|Reported Event|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
496591|NCT00764504|E1|Reported Event|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
496592|NCT00764478|B4|Baseline|Total|Total of all reporting groups
496593|NCT00764478|B3|Baseline|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496594|NCT00764478|B2|Baseline|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496595|NCT00764478|B1|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496596|NCT00764478|P3|Participant Flow|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496597|NCT00764478|P2|Participant Flow|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496598|NCT00764478|P1|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually twice daily (BID) for 21 days
496599|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496600|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496601|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496602|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496603|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496604|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496605|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496606|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496607|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496608|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496609|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496610|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496611|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496612|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496613|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496614|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496615|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496616|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496617|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496618|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496619|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496620|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
497280|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
496621|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496622|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496623|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496624|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496625|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496626|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496627|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496628|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496629|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496630|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496631|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496632|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496633|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496634|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496635|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496636|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496637|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496638|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496639|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496640|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496641|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496642|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496643|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496644|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496645|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496646|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496647|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496648|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496649|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496650|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496651|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496652|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496653|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496654|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496655|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496656|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496657|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496658|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496659|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496660|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496661|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496662|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496663|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496664|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496665|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496666|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
496667|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496668|NCT00764478|E3|Reported Event|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
496669|NCT00764478|E2|Reported Event|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
497281|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
496670|NCT00764478|E1|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
496671|NCT00764465|B7|Baseline|Total|Total of all reporting groups
496672|NCT00764465|B6|Baseline|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
496673|NCT00764465|B5|Baseline|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
496674|NCT00764465|B4|Baseline|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
496675|NCT00764465|B3|Baseline|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
496676|NCT00764465|B2|Baseline|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
496677|NCT00764465|B1|Baseline|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
496678|NCT00764465|P6|Participant Flow|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
496679|NCT00764465|P5|Participant Flow|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
496680|NCT00764465|P4|Participant Flow|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
496681|NCT00764465|P3|Participant Flow|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
496682|NCT00764465|P2|Participant Flow|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
496683|NCT00764465|P1|Participant Flow|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
496684|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
496685|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
496686|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
496687|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
496688|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
496689|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
496690|NCT00764465|O6|Outcome|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
496691|NCT00764465|O5|Outcome|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
496692|NCT00764465|O4|Outcome|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
496693|NCT00764465|O3|Outcome|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
496694|NCT00764465|O2|Outcome|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
496695|NCT00764465|O1|Outcome|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
496696|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
496697|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
496698|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
496699|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
496700|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
496701|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
496702|NCT00764465|E6|Reported Event|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
496703|NCT00764465|E5|Reported Event|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
496704|NCT00764465|E4|Reported Event|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
496705|NCT00764465|E3|Reported Event|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
496706|NCT00764465|E2|Reported Event|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
496707|NCT00764465|E1|Reported Event|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
496708|NCT00764361|B3|Baseline|Total|Total of all reporting groups
496709|NCT00764361|B2|Baseline|Placebo|placebo gel
496710|NCT00764361|B1|Baseline|NanoDOX™ Hydrogel|1.0% doxycycline gel
496711|NCT00764361|P2|Participant Flow|Placebo|placebo gel
496712|NCT00764361|P1|Participant Flow|NanoDOX™ Hydrogel|1.0% doxycycline gel
496713|NCT00764361|O2|Outcome|Placebo|placebo gel
496714|NCT00764361|O1|Outcome|NanoDOX™ Hydrogel|1.0% doxycycline monohydrate gel
496715|NCT00764361|E2|Reported Event|Placebo|placebo gel
496716|NCT00764361|E1|Reported Event|NanoDOX™ Hydrogel|1.0% doxycycline gel
496717|NCT00764322|B3|Baseline|Total|Total of all reporting groups
496718|NCT00764322|B2|Baseline|Intermediate and Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496719|NCT00764322|B1|Baseline|Extensive and Ultra-rapid Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
496720|NCT00764322|P1|Participant Flow|Patients Enrolled|
496721|NCT00764322|O1|Outcome|All Participants|All participants in the main study who consented to this additional survey
496722|NCT00764322|O1|Outcome|Poor Metabolizers|Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496723|NCT00764322|O1|Outcome|African Americans|Participants who self identified as African American Race
496724|NCT00764322|O3|Outcome|Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496725|NCT00764322|O2|Outcome|Intermediate Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496726|NCT00764322|O1|Outcome|Extensive Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
496727|NCT00764322|O2|Outcome|Tamoxifen 40|"This arm, containing the intermediate and poor metabolizer genotypes, receives escalated treatment with tamoxifen at 40mg.~tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.~gene expression analysis: Genetic analysis of blood sample.~pharmacogenomic studies: Genetic analysis of blood sample.~questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months~quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months."
496728|NCT00764322|O1|Outcome|Tamoxifen 20|"One arm, containing the ultra-rapid and extensive metabolizer genotypes, continues treatment with tamoxifen at 20mg.~tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.~gene expression analysis: Genetic analysis of blood sample.~pharmacogenomic studies: Genetic analysis of blood sample.~questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months~quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months."
496729|NCT00764322|O4|Outcome|Poor Metabolizers|Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496730|NCT00764322|O3|Outcome|Intermediate Metabolizers|Those with reduced transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496731|NCT00764322|O2|Outcome|Extensive Metabolizers|Those with the most normal transformation of the CYP2D6 genotype to allelic activity
496732|NCT00764322|O1|Outcome|Ultra-rapid Metabolizers|Those with the highest transformation of the CYP2D6 genotype to allelic activity
496733|NCT00764322|E3|Reported Event|Poor Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496734|NCT00764322|E2|Reported Event|Intermediate Metabolizers|Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
496735|NCT00764322|E1|Reported Event|Ultra-rapid and Extensive Metabolizers|Those with the highest endoxifen concentrations as measured at baseline.
496736|NCT00764309|B1|Baseline|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
496737|NCT00764309|P1|Participant Flow|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
496846|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496738|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
496739|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
496740|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
496741|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
496742|NCT00764309|E1|Reported Event|Dasatinib|
496743|NCT00763971|B4|Baseline|Total|Total of all reporting groups
496744|NCT00763971|B3|Baseline|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496745|NCT00763971|B2|Baseline|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496746|NCT00763971|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496747|NCT00763971|P3|Participant Flow|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496748|NCT00763971|P2|Participant Flow|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496749|NCT00763971|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496750|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496751|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496752|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496753|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496754|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496755|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496756|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496757|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496758|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496759|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496760|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496761|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496762|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496763|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496764|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496765|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496766|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496767|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496768|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496847|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496769|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496770|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496771|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496772|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496773|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496774|NCT00763971|E3|Reported Event|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
496775|NCT00763971|E2|Reported Event|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
496776|NCT00763971|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
496777|NCT00763958|B3|Baseline|Total|Total of all reporting groups
496778|NCT00763958|B2|Baseline|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
496779|NCT00763958|B1|Baseline|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
496780|NCT00763958|P2|Participant Flow|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
496781|NCT00763958|P1|Participant Flow|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
496782|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
496783|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
496784|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
496785|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of stuty drug based on clinical assessment.
496786|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
496787|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
496788|NCT00763958|E2|Reported Event|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
496789|NCT00763958|E1|Reported Event|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
496790|NCT00763919|B1|Baseline|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496791|NCT00763919|P1|Participant Flow|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496792|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496793|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496794|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496795|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496796|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496797|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496798|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496799|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496800|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496801|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496802|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496848|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
497282|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
496803|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496804|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496805|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496806|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496807|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496808|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496809|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496810|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496811|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496812|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496813|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496814|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496815|NCT00763919|E1|Reported Event|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
496816|NCT00763867|B3|Baseline|Total|Total of all reporting groups
496817|NCT00763867|B2|Baseline|Sildenafil|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
496818|NCT00763867|B1|Baseline|Placebo|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
496819|NCT00763867|P2|Participant Flow|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496820|NCT00763867|P1|Participant Flow|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496821|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496822|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496823|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496824|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496825|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496826|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496827|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496828|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496829|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496830|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496831|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496832|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496833|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496834|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496835|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496836|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496837|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496838|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496839|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496840|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496841|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496842|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496843|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496844|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496845|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
497283|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
496849|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496850|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496851|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496852|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496853|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496854|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496855|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496856|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496857|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496858|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496859|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496860|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496861|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496862|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496863|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496864|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496865|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496866|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496867|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496868|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496869|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496870|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496871|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496872|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496873|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496874|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496875|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496876|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496877|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496878|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496879|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496880|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496881|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496882|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496883|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496884|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496885|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496886|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496887|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496888|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496889|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496890|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496891|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496892|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496893|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496894|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496895|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496896|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496897|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496898|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496899|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496900|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496901|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496902|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496903|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496904|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
497284|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
496905|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496906|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496907|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496908|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496909|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496910|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496911|NCT00763867|E2|Reported Event|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496912|NCT00763867|E1|Reported Event|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
496913|NCT00763815|B3|Baseline|Total|Total of all reporting groups
496914|NCT00763815|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg once daily QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496915|NCT00763815|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496916|NCT00763815|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496917|NCT00763815|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496918|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496919|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496920|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496921|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496922|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496923|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496924|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496925|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496926|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496927|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496928|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496929|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496930|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496931|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496932|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496933|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496934|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496935|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496936|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
496937|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
496938|NCT00763815|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
496939|NCT00763815|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
496940|NCT00763750|B1|Baseline|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
496941|NCT00763750|P1|Participant Flow|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
496942|NCT00763750|O1|Outcome|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
496943|NCT00763750|E1|Reported Event|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
496944|NCT00763698|B1|Baseline|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
496945|NCT00763698|P1|Participant Flow|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
496946|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Leads|Patients included in this analysis include the first 16 patients to provide LV lead bipolar pacing capture threshold data at 3 months with a pulse width of 0.5 ms.
496947|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
497060|NCT00763321|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
496948|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
496949|NCT00763698|E1|Reported Event|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
496950|NCT00763490|B1|Baseline|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
496951|NCT00763490|P1|Participant Flow|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
496952|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
496953|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
496954|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
496955|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
496956|NCT00763490|E1|Reported Event|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
496957|NCT00763451|B5|Baseline|Total|Total of all reporting groups
496958|NCT00763451|B4|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
496959|NCT00763451|B3|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496960|NCT00763451|B2|Baseline|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
496961|NCT00763451|B1|Baseline|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496962|NCT00763451|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
496963|NCT00763451|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496964|NCT00763451|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
496965|NCT00763451|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
496966|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496967|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496968|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496969|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496970|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496971|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496972|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496973|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496974|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496975|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496976|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496977|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496978|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496979|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496980|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496981|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496982|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496983|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496984|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496985|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496986|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496987|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
496988|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
496989|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496990|NCT00763451|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
496991|NCT00763451|E5|Reported Event|Lixisenatide One-step Titration|1-step initiation regimen of lixisenatide.
496992|NCT00763451|E4|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
496993|NCT00763451|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
496994|NCT00763451|E2|Reported Event|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo.
496995|NCT00763451|E1|Reported Event|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo.
496996|NCT00763412|B3|Baseline|Total|Total of all reporting groups
496997|NCT00763412|B2|Baseline|Patients Who Received Repaglinide|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
496998|NCT00763412|B1|Baseline|Patients Who Received Placebo|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
496999|NCT00763412|P2|Participant Flow|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497000|NCT00763412|P1|Participant Flow|Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497001|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497002|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497003|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497004|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497005|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497006|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497007|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497008|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497009|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497010|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497011|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497012|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497013|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497014|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497015|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497016|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497017|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497018|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
497019|NCT00763412|E2|Reported Event|Repaglinide|Repaglinide intervention group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
497020|NCT00763412|E1|Reported Event|Placebo|Placebo group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
497021|NCT00763386|B3|Baseline|Total|Total of all reporting groups
497022|NCT00763386|B2|Baseline|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
497023|NCT00763386|B1|Baseline|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
497024|NCT00763386|P2|Participant Flow|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
497025|NCT00763386|P1|Participant Flow|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
497026|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
497027|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
497028|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
497029|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
497030|NCT00763386|E2|Reported Event|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
497031|NCT00763386|E1|Reported Event|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
497032|NCT00763360|B4|Baseline|Total|Total of all reporting groups
497033|NCT00763360|B3|Baseline|Amvisc Plus|Amvisc Plus
497034|NCT00763360|B2|Baseline|Healon|Healon
497035|NCT00763360|B1|Baseline|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
497036|NCT00763360|P3|Participant Flow|Amvisc Plus|Amvisc Plus
497037|NCT00763360|P2|Participant Flow|Healon|Healon
497038|NCT00763360|P1|Participant Flow|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
497039|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
497040|NCT00763360|O2|Outcome|Healon|Healon
497041|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
497042|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
497043|NCT00763360|O2|Outcome|Healon|Healon
497044|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
497045|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
497046|NCT00763360|O2|Outcome|Healon|Healon
497047|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
497048|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
497049|NCT00763360|O2|Outcome|Healon|Healon
497050|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
497051|NCT00763360|E3|Reported Event|Amvisc Plus|Amvisc Plus
497052|NCT00763360|E2|Reported Event|Healon|Healon
497053|NCT00763360|E1|Reported Event|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
497054|NCT00763321|B4|Baseline|Total|Total of all reporting groups
497055|NCT00763321|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
497056|NCT00763321|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
497057|NCT00763321|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
497058|NCT00763321|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
497059|NCT00763321|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
497285|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
497061|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
497062|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
497063|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
497064|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
497065|NCT00763321|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
497066|NCT00763321|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
497067|NCT00763321|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
497068|NCT00763282|B3|Baseline|Total|Total of all reporting groups
497069|NCT00763282|B2|Baseline|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497070|NCT00763282|B1|Baseline|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
497071|NCT00763282|P2|Participant Flow|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497072|NCT00763282|P1|Participant Flow|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
497073|NCT00763282|O2|Outcome|ED Group|"An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.~The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497074|NCT00763282|O1|Outcome|SM+MI Group|Self Management (SM) + Motivational Interviewing (MI). Motivational Interviewing (MI) is an evidence-based form of counseling to improve behavior change. Self Management (SM) includes: 1) ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
497075|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497076|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
497077|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497078|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
497141|NCT00763139|P1|Participant Flow|Placebo 1st, Pioglitazone 2nd|"Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
497079|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497080|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
497081|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497082|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
497083|NCT00763282|E2|Reported Event|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
497084|NCT00763282|E1|Reported Event|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
497085|NCT00763269|B3|Baseline|Total|Total of all reporting groups
497086|NCT00763269|B2|Baseline|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
497087|NCT00763269|B1|Baseline|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
497088|NCT00763269|P2|Participant Flow|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
497089|NCT00763269|P1|Participant Flow|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
497090|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
497091|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
497092|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
497093|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
497094|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
497095|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
497096|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
497097|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
497098|NCT00763269|E2|Reported Event|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
497099|NCT00763269|E1|Reported Event|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
497100|NCT00763256|B3|Baseline|Total|Total of all reporting groups
497101|NCT00763256|B2|Baseline|B - Placebo Comparator|fluoride only toothpaste
497102|NCT00763256|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
497103|NCT00763256|P2|Participant Flow|B - Placebo Comparator|fluoride only toothpaste
497104|NCT00763256|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
497105|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
497106|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497107|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
497108|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497109|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
497110|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497111|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
497112|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497113|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
497114|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497115|NCT00763256|E2|Reported Event|B - Placebo Comparator|fluoride only toothpaste
497116|NCT00763256|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
497142|NCT00763139|O4|Outcome|Placebo Phase After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
497117|NCT00763243|B1|Baseline|Cogmed Working Memory Training|"Cogmed Working Memory Training Program~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
497118|NCT00763243|P1|Participant Flow|Cogmed Working Memory Training|"Cogmed Working Memory Training Program~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
497119|NCT00763243|O5|Outcome|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
497120|NCT00763243|O4|Outcome|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
497121|NCT00763243|O3|Outcome|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
497122|NCT00763243|O2|Outcome|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
497123|NCT00763243|O1|Outcome|Screening Visit|"Screening Visit at Study Entry~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
497124|NCT00763243|O5|Outcome|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
497125|NCT00763243|O4|Outcome|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
497126|NCT00763243|O3|Outcome|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
497127|NCT00763243|O2|Outcome|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
497128|NCT00763243|O1|Outcome|Screening Visit|"Screening Visit at Study Entry~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
497129|NCT00763243|O5|Outcome|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
497130|NCT00763243|O4|Outcome|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
497131|NCT00763243|O3|Outcome|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
497132|NCT00763243|O2|Outcome|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
497133|NCT00763243|O1|Outcome|Screening Visit|"Screening Visit at Study Entry~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
497134|NCT00763243|E5|Reported Event|6-Month Follow Up Visit|Visit 6 months after Cogmed working memory training completed
497135|NCT00763243|E4|Reported Event|1-Month Follow Up Visit|Visit 1 month after Cogmed working memory training was completed
497136|NCT00763243|E3|Reported Event|Posttraining Visit|Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
497137|NCT00763243|E2|Reported Event|Pretraining Visit|Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
497138|NCT00763243|E1|Reported Event|Screening Visit|"Screening Visit at Study Entry~Cogmed Working Memory Training Program : The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success."
497139|NCT00763139|B1|Baseline|Baseline Characteristics of Participants|participants who met American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA), age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month
497140|NCT00763139|P2|Participant Flow|Pioglitazone 1st, Placebo 2nd|"Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
497185|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497143|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
497144|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
497145|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
497146|NCT00763139|O4|Outcome|Placebo Phase wk After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks on medication are reported here.
497147|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
497148|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
497149|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
497150|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
497151|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
497152|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
497153|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
497154|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
497155|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
497156|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
497157|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
497158|NCT00763139|E2|Reported Event|Placebo|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking placebo
497159|NCT00763139|E1|Reported Event|Pioglitazone|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking pioglitazone
497160|NCT00763061|B3|Baseline|Total|Total of all reporting groups
497161|NCT00763061|B2|Baseline|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
497162|NCT00763061|B1|Baseline|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
497163|NCT00763061|P2|Participant Flow|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
497164|NCT00763061|P1|Participant Flow|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
497165|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
497166|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
497167|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
497168|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
497169|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
497170|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
497171|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
497172|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
497173|NCT00763061|E2|Reported Event|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
497174|NCT00763061|E1|Reported Event|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
497175|NCT00763048|B3|Baseline|Total|Total of all reporting groups
497176|NCT00763048|B2|Baseline|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497177|NCT00763048|B1|Baseline|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497178|NCT00763048|P2|Participant Flow|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497179|NCT00763048|P1|Participant Flow|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497180|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497181|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497182|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497183|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497184|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497186|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497187|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497188|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497189|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497190|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497191|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497192|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497193|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497194|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497195|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497196|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497197|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497198|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497199|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497200|NCT00763048|E2|Reported Event|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
497201|NCT00763048|E1|Reported Event|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
497202|NCT00763009|B1|Baseline|Dipyridamole|Pre: Baseline Results prior to administration of Dipyridamole. Post: Results post adminsitration of Dipyridamole
497203|NCT00763009|P1|Participant Flow|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
497204|NCT00763009|O1|Outcome|All Subjects Receive Dipyridamole|There is only a single arm dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
497205|NCT00763009|O1|Outcome|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
497206|NCT00763009|E1|Reported Event|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
497207|NCT00762996|B1|Baseline|Entire Population|
497208|NCT00762996|P4|Participant Flow|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
497209|NCT00762996|P3|Participant Flow|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
497210|NCT00762996|P2|Participant Flow|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
497211|NCT00762996|P1|Participant Flow|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
497212|NCT00762996|O2|Outcome|Omafilcon A|
497213|NCT00762996|O1|Outcome|Etafilcon A|
497214|NCT00762996|O2|Outcome|Omafilcon A|
497215|NCT00762996|O1|Outcome|Etafilcon A|
497216|NCT00762996|E4|Reported Event|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
497217|NCT00762996|E3|Reported Event|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
497218|NCT00762996|E2|Reported Event|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
497219|NCT00762996|E1|Reported Event|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
497220|NCT00762970|B4|Baseline|Total|Total of all reporting groups
497221|NCT00762970|B3|Baseline|Control Lens|Spectacle lenses worn daily.
497222|NCT00762970|B2|Baseline|Test Lens 2|Investigational soft contact lens worn daily.
497223|NCT00762970|B1|Baseline|Test Lens 1|Investigational soft contact lens worn daily.
497224|NCT00762970|P3|Participant Flow|Control Lens|Control spectacle lenses worn daily.
497225|NCT00762970|P2|Participant Flow|Test Lens 2|Investigational soft contact lenses worn daily.
497226|NCT00762970|P1|Participant Flow|Test Lens 1|Investigational soft contact lenses worn daily.
497227|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
497228|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
497229|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
497230|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
497231|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
497232|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
497233|NCT00762970|E3|Reported Event|Control Lens|Control spectacle lenses worn daily.
497234|NCT00762970|E2|Reported Event|Test Lens 2|Investigational soft contact lenses worn daily.
497235|NCT00762970|E1|Reported Event|Test Lens 1|Investigational soft contact lenses worn daily.
497236|NCT00762931|B1|Baseline|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
497237|NCT00762931|P1|Participant Flow|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
497238|NCT00762931|O1|Outcome|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
497239|NCT00762931|O1|Outcome|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
497240|NCT00762931|E1|Reported Event|Resolve Stimulator and Proximity Lead|"An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment~Resolve Stimulator and Proximity Lead: An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation"
497241|NCT00762892|B3|Baseline|Total|Total of all reporting groups
497242|NCT00762892|B2|Baseline|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497243|NCT00762892|B1|Baseline|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497244|NCT00762892|P2|Participant Flow|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497245|NCT00762892|P1|Participant Flow|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497246|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497247|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497248|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497249|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497250|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497251|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497252|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497253|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497254|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497255|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497256|NCT00762892|E2|Reported Event|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
497257|NCT00762892|E1|Reported Event|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
497258|NCT00762853|B3|Baseline|Total|Total of all reporting groups
497259|NCT00762853|B2|Baseline|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
497260|NCT00762853|B1|Baseline|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
497261|NCT00762853|P2|Participant Flow|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
497262|NCT00762853|P1|Participant Flow|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
497263|NCT00762853|O2|Outcome|Active Toothpaste|fluoride/triclosan/copolymer(Active) toothpaste
497264|NCT00762853|O1|Outcome|Fluoride Toothpaste (Placebo)|fluoride only toothpaste
497265|NCT00762853|E2|Reported Event|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
497266|NCT00762853|E1|Reported Event|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
497267|NCT00762788|B7|Baseline|Total|Total of all reporting groups
497268|NCT00762788|B6|Baseline|Etafilcon A Contact Lens|ACUVUE 2
497269|NCT00762788|B5|Baseline|Comfilcon A Contact Lens|Biofinity
497297|NCT00762788|E1|Reported Event|Senofilcon A Contact Lens|ACUVUE OASYS
497298|NCT00762762|B3|Baseline|Total|Total of all reporting groups
497299|NCT00762762|B2|Baseline|Placebo Comparator|Anti-cavity, fluoride oral rinse
497300|NCT00762762|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
497301|NCT00762762|P2|Participant Flow|Placebo Comparator|Anti-cavity, fluoride oral rinse
497302|NCT00762762|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
497303|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
497304|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497305|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
497306|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497307|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
497308|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497309|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
497310|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497311|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
497312|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
497313|NCT00762762|E2|Reported Event|Placebo Comparator|Anti-cavity, fluoride oral rinse
497314|NCT00762762|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
497315|NCT00762723|B4|Baseline|Total|Total of all reporting groups
497316|NCT00762723|B3|Baseline|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497317|NCT00762723|B2|Baseline|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497318|NCT00762723|B1|Baseline|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497319|NCT00762723|P3|Participant Flow|ALP With Hybrid Screws|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497320|NCT00762723|P2|Participant Flow|ALP With Variable Screws|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497321|NCT00762723|P1|Participant Flow|ALP With Fixed Screws|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497322|NCT00762723|O3|Outcome|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497323|NCT00762723|O2|Outcome|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497324|NCT00762723|O1|Outcome|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497325|NCT00762723|E3|Reported Event|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497326|NCT00762723|E2|Reported Event|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497392|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497327|NCT00762723|E1|Reported Event|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
497328|NCT00762645|B3|Baseline|Total|Total of all reporting groups
497329|NCT00762645|B2|Baseline|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
497330|NCT00762645|B1|Baseline|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
497331|NCT00762645|P2|Participant Flow|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
497332|NCT00762645|P1|Participant Flow|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
497333|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
497334|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
497335|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
497336|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
497337|NCT00762645|E2|Reported Event|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
497338|NCT00762645|E1|Reported Event|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
497339|NCT00762619|B3|Baseline|Total|Total of all reporting groups
497340|NCT00762619|B2|Baseline|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497341|NCT00762619|B1|Baseline|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497342|NCT00762619|P2|Participant Flow|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497343|NCT00762619|P1|Participant Flow|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497344|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497345|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497346|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497347|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497348|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497349|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497350|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497351|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497352|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497353|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497354|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497355|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497356|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497357|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497358|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497359|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497360|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497361|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497362|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497363|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497364|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497365|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497366|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497367|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497368|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497369|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497370|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497371|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497372|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497373|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497374|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497375|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497376|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497377|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497378|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497379|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497380|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497381|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497382|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497383|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497384|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497385|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497386|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497387|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497388|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497389|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497390|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497391|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497393|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497394|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497395|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497396|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497397|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497398|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497399|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497400|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497401|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497402|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497403|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497404|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497405|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497406|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497407|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497408|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497409|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497410|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497411|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497412|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497413|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497414|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497415|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497416|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497417|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497418|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497419|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497420|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497421|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497422|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497423|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497424|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497425|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497426|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497427|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497428|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497429|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497430|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497431|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497432|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497433|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497434|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497435|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497436|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497437|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497438|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497439|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497440|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497441|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497442|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497443|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497444|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497445|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497446|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497447|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497448|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497449|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497450|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497451|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497452|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497453|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497454|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
497455|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
497456|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497457|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497458|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497459|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497460|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497461|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497462|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497463|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497464|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497465|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497466|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497467|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497468|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497469|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497470|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497471|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497472|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497473|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497474|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497475|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497476|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497477|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497478|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497479|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497480|NCT00762619|E2|Reported Event|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497481|NCT00762619|E1|Reported Event|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
497482|NCT00762606|B3|Baseline|Total|Total of all reporting groups
497483|NCT00762606|B2|Baseline|SICS|Small incision cataract surgery (SICS)
497484|NCT00762606|B1|Baseline|Phaco|cataract extraction surgery utilizing Phacoemulsification
497485|NCT00762606|P2|Participant Flow|SICS|Small incision cataract surgery (SICS)
497486|NCT00762606|P1|Participant Flow|Phaco|cataract extraction surgery utilizing Phacoemulsification
497487|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
497488|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
497489|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
497490|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
497491|NCT00762606|E2|Reported Event|SICS|Small incision cataract surgery (SICS)
497492|NCT00762606|E1|Reported Event|Phaco|cataract extraction surgery utilizing Phacoemulsification
497493|NCT00762528|B3|Baseline|Total|Total of all reporting groups
497494|NCT00762528|B2|Baseline|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497495|NCT00762528|B1|Baseline|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497496|NCT00762528|P2|Participant Flow|Fluoride Toothpaste|Sodium monofluorophosphate toothpaste
497497|NCT00762528|P1|Participant Flow|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497498|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497499|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497500|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497501|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497502|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497503|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497504|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497505|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497506|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497507|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497508|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497509|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497510|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497511|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497512|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497513|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497555|NCT00762476|E2|Reported Event|3804-250A|Experimental AV Lotion
497514|NCT00762528|E2|Reported Event|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
497515|NCT00762528|E1|Reported Event|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
497516|NCT00762515|B3|Baseline|Total|Total of all reporting groups
497517|NCT00762515|B2|Baseline|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
497518|NCT00762515|B1|Baseline|A -Placebo Comparator|Fluoride toothpaste
497519|NCT00762515|P2|Participant Flow|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
497520|NCT00762515|P1|Participant Flow|A -Placebo Comparator|Fluoride toothpaste
497521|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
497522|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
497523|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
497524|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
497525|NCT00762515|E2|Reported Event|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
497526|NCT00762515|E1|Reported Event|A -Placebo Comparator|Fluoride toothpaste
497527|NCT00762502|B4|Baseline|Total|Total of all reporting groups
497528|NCT00762502|B3|Baseline|Senofilcon A/Balafilcon A Contralaterally|senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
497529|NCT00762502|B2|Baseline|Balafilcon A Toric Bilaterally|balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
497530|NCT00762502|B1|Baseline|Senofilcon A Toric Bilaterally|senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
497531|NCT00762502|P3|Participant Flow|Senofilcon A Toric/Balafilcon A Toric Contralaterally|Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
497532|NCT00762502|P2|Participant Flow|Balafilcon A Bilaterally|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
497533|NCT00762502|P1|Participant Flow|Senofilcon A Bilaterally|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
497534|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497535|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497536|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497537|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497538|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497539|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497540|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497541|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
497542|NCT00762502|E2|Reported Event|Balafilcon A|balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
497543|NCT00762502|E1|Reported Event|Senofilcon A|senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
497544|NCT00762476|B3|Baseline|Total|Total of all reporting groups
497545|NCT00762476|B2|Baseline|3804-250A|Experimental AV Lotion
497546|NCT00762476|B1|Baseline|Placebo|Modified AV Lotion without active ingredients.
497547|NCT00762476|P2|Participant Flow|3804-250A|Experimental AV Lotion
497548|NCT00762476|P1|Participant Flow|Placebo|Modified AV Lotion without active ingredients.
497549|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
497550|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
497551|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
497552|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
497553|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
497554|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients
497556|NCT00762476|E1|Reported Event|Placebo|Modified AV Lotion without active ingredients.
497557|NCT00762463|B3|Baseline|Total|Total of all reporting groups
497558|NCT00762463|B2|Baseline|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497559|NCT00762463|B1|Baseline|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497560|NCT00762463|P4|Participant Flow|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497561|NCT00762463|P3|Participant Flow|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497562|NCT00762463|P2|Participant Flow|Diclofenac SR 75 mg|Diclofenac sustained release (SR) 75 mg tablet once daily
497563|NCT00762463|P1|Participant Flow|Celecoxib 200 mg|Celecoxib 200 milligram (mg) capsule once daily
497564|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497565|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497566|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497567|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497568|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497569|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497570|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497571|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497572|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497573|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497574|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497575|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497576|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497577|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497578|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497579|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497580|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497581|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497582|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497583|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497584|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497585|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497586|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497587|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497588|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497589|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497590|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497591|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497592|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497593|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497594|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497595|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497596|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497597|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497598|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497599|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497600|NCT00762463|O4|Outcome|Diclofenac 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 and Celecoxib 400 mg once daily from Week 6 to Week 12
497601|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497602|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497603|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497604|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497605|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497606|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497607|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497608|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497609|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497610|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497611|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497612|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497613|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497614|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497615|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497616|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497617|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497618|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497619|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497620|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497621|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497622|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497623|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497624|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497625|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497626|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497627|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497628|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497629|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497630|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497631|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497632|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497633|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497634|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497635|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497636|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
497637|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
497638|NCT00762463|E6|Reported Event|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497639|NCT00762463|E5|Reported Event|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
497640|NCT00762463|E4|Reported Event|Diclofenac SR 75 mg, Then Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12
497641|NCT00762463|E3|Reported Event|Celecoxib 200 mg, Then Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12
497642|NCT00762463|E2|Reported Event|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6
497643|NCT00762463|E1|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6
497644|NCT00762450|B4|Baseline|Total|Total of all reporting groups
497645|NCT00762450|B3|Baseline|Experimental First, Placebo Second and Positive Control Last|
497646|NCT00762450|B2|Baseline|Positive Control First, Experimental Second and Placebo Last|
497647|NCT00762450|B1|Baseline|Placebo First, Positive Control Second and Experimental Last|
497648|NCT00762450|P3|Participant Flow|Experimental 1st, Placebo 2nd and Active Comparator Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
497649|NCT00762450|P2|Participant Flow|Active Comparator 1st, Experimental 2nd and Placebo Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
497650|NCT00762450|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
497651|NCT00762450|O3|Outcome|Experimental Toothpaste|
497652|NCT00762450|O2|Outcome|Placebo - Silica Control|
497653|NCT00762450|O1|Outcome|Active Comparator|
497654|NCT00762450|E3|Reported Event|Experimental First, Placebo Second and Positive Control Last|
497655|NCT00762450|E2|Reported Event|Positive Control First, Experimental Second and Placebo Last|
497656|NCT00762450|E1|Reported Event|Placebo First, Positive Control Second and Experimental Last|
497657|NCT00762424|B3|Baseline|Total|Total of all reporting groups
497658|NCT00762424|B2|Baseline|Placebo|placebo: cornstarch
497659|NCT00762424|B1|Baseline|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
497661|NCT00762424|P1|Participant Flow|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
497662|NCT00762424|O2|Outcome|Placebo|placebo: cornstarch
497663|NCT00762424|O1|Outcome|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
497664|NCT00762424|E2|Reported Event|Placebo|placebo: cornstarch
497665|NCT00762424|E1|Reported Event|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
497666|NCT00762411|B3|Baseline|Total|Total of all reporting groups
497667|NCT00762411|B2|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497668|NCT00762411|B1|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497669|NCT00762411|P2|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497670|NCT00762411|P1|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497671|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497672|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497673|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497674|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497675|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497676|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497677|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497678|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497679|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497680|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497681|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497682|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497683|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497684|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497685|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497686|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497687|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497688|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497689|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497690|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497691|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497692|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497693|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497694|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497695|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497696|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497697|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497698|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497699|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497700|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497701|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497702|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497703|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497704|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497705|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497706|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497707|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497708|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497709|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497710|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497711|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497712|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497713|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497714|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497715|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497716|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497717|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497718|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497719|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497720|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497721|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497722|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497723|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497724|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497764|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497725|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
497726|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497727|NCT00762411|E6|Reported Event|140 mg LY450139 - SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
497728|NCT00762411|E5|Reported Event|Placebo-Safety Follow Up Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
497729|NCT00762411|E4|Reported Event|140 mg LY450139- DO|After Week 76, participants received 140 mg LY450139 orally once daily until Week 88.
497730|NCT00762411|E3|Reported Event|Placebo- (Delayed Start Period [DO])|After Week 76, participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
497731|NCT00762411|E2|Reported Event|140 mg LY450139- NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 76.
497732|NCT00762411|E1|Reported Event|Placebo- (Initial Treatment Period [NT])|Participants received placebo orally once daily for the first 76 weeks.
497733|NCT00762385|B1|Baseline|Completed Population|Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study.
497734|NCT00762385|P2|Participant Flow|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
497735|NCT00762385|P1|Participant Flow|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
497736|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or the second intervention period.
497737|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
497738|NCT00762385|O2|Outcome|Comfilcon A|
497739|NCT00762385|O1|Outcome|Galyfilcon A|
497740|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or second intervention period.
497741|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
497742|NCT00762385|E2|Reported Event|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
497743|NCT00762385|E1|Reported Event|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
497744|NCT00762359|B3|Baseline|Total|Total of all reporting groups
497745|NCT00762359|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497746|NCT00762359|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497747|NCT00762359|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497748|NCT00762359|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497749|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497750|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497751|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497752|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497753|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497754|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497755|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497756|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497757|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497758|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497759|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497760|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497761|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497762|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497763|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497879|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
497765|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497766|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497767|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497768|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497769|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497770|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497771|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497772|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497773|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497774|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497775|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497776|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497777|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497778|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497779|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497780|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497781|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497782|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497783|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497784|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497785|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497786|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497787|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497788|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497789|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497790|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497791|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497792|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497793|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497794|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497795|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497796|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497797|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497798|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497799|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497800|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497801|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497802|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497803|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497804|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497805|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497806|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497807|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497808|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497809|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497810|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497811|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497812|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497813|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497814|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497815|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497816|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497817|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497818|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497819|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497820|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497821|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497822|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497823|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497824|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497825|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497826|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497827|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497828|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497829|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497830|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497831|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497832|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497833|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497834|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497835|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497836|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497837|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497838|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497839|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497840|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497841|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497842|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497843|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497844|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497845|NCT00762359|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
497846|NCT00762359|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
497847|NCT00762320|B1|Baseline|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
497848|NCT00762320|P1|Participant Flow|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
497849|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4|Patients Receiving Low Dose Kaletra at Week 4
497850|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline|Patients receiving Low Dose Kaletra at baseline
497851|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
497852|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
497853|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
497854|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra
497855|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4 Visit|Patient Satisfaction Score at Week 4 visit
497856|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline Visit|Patient satisfaction score at baseline visit
497857|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
497858|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
497859|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
497860|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
497861|NCT00762320|E1|Reported Event|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
497862|NCT00762268|B3|Baseline|Total|Total of all reporting groups
497863|NCT00762268|B2|Baseline|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
497864|NCT00762268|B1|Baseline|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
497865|NCT00762268|P2|Participant Flow|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
497866|NCT00762268|P1|Participant Flow|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
497867|NCT00762268|O2|Outcome|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
497868|NCT00762268|O1|Outcome|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
497869|NCT00762268|E2|Reported Event|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
497870|NCT00762268|E1|Reported Event|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
497871|NCT00762229|B3|Baseline|Total|Total of all reporting groups
497872|NCT00762229|B2|Baseline|Ezetimibe 5 mg|Ezetimibe 5 mg,
497873|NCT00762229|B1|Baseline|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
497874|NCT00762229|P2|Participant Flow|Ezetimibe 5 mg|Ezetimibe 5 mg,
497875|NCT00762229|P1|Participant Flow|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
497876|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
497877|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
497878|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
497881|NCT00762229|E1|Reported Event|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
497882|NCT00762216|B1|Baseline|Toric|Implantation with the AcrySof® Toric intraocular lens
497883|NCT00762216|P1|Participant Flow|Toric|Implantation with the AcrySof® Toric intraocular lens
497884|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
497885|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
497886|NCT00762216|E1|Reported Event|Toric|Implantation with the AcrySof® Toric intraocular lens
497887|NCT00762177|B4|Baseline|Total|Total of all reporting groups
497888|NCT00762177|B3|Baseline|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
497889|NCT00762177|B2|Baseline|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
497890|NCT00762177|B1|Baseline|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
497891|NCT00762177|P3|Participant Flow|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
497892|NCT00762177|P2|Participant Flow|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
497893|NCT00762177|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
497894|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497895|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497896|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497897|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497898|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497899|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497900|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497901|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497902|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497903|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497904|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497905|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497906|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497907|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497908|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497909|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497910|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497911|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497912|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497913|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497914|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497915|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497916|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497917|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497918|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497919|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497920|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497921|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497922|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497923|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497924|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497925|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497926|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497927|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497928|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497929|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497930|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497931|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497932|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497933|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497934|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497935|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497936|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497937|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497938|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497939|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497940|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497941|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497942|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497943|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497944|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497945|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497946|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497947|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497948|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497949|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497950|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497951|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497952|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497953|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497954|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497955|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497956|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497957|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497958|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497959|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497960|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497961|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
497962|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only)
497963|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
497964|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).
497965|NCT00762177|O1|Outcome|Placebo Toothpaste|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
497966|NCT00762177|E3|Reported Event|Experimental|Experimental test product (stannous fluoride toothpaste)
497967|NCT00762177|E2|Reported Event|Active Comparator|Active Comparator toothpaste containing fluoride/triclosan/copolymer (Total)
497968|NCT00762177|E1|Reported Event|Placebo - Fluoride Control|Fluoride only toothpaste (Crest Anti-Cavity)
497969|NCT00762164|B3|Baseline|Total|Total of all reporting groups
497970|NCT00762164|B2|Baseline|Simvastatin|Simvastatin 20 milligrams
497971|NCT00762164|B1|Baseline|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
497972|NCT00762164|P2|Participant Flow|Simvastatin|Simvastatin 20 milligrams
497973|NCT00762164|P1|Participant Flow|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
497974|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
497975|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
497976|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
497977|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
497978|NCT00762164|E2|Reported Event|Simvastatin|Simvastatin 20 milligrams
497979|NCT00762164|E1|Reported Event|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
497980|NCT00762086|B3|Baseline|Total|Total of all reporting groups
497981|NCT00762086|B2|Baseline|Control Group|Aspirin/Clopidegrol and Standard walking exercises
497982|NCT00762086|B1|Baseline|Treatment Group|AngioPress IPC Device
497983|NCT00762086|P2|Participant Flow|Control Group|Aspirin/Clopidegrol and Standard walking exercises
497984|NCT00762086|P1|Participant Flow|Treatment Group|AngioPress IPC Device
497985|NCT00762086|O2|Outcome|Control Group|Aspirin/Clopidegrol and Standard walking exercises
497986|NCT00762086|O1|Outcome|Treatment Group|AngioPress IPC Device
497987|NCT00762086|E2|Reported Event|Control Group|Aspirin/Clopidegrol and Standard walking exercises
497988|NCT00762086|E1|Reported Event|Treatment Group|AngioPress IPC Device
497989|NCT00762073|B5|Baseline|Total|Total of all reporting groups
497990|NCT00762073|B4|Baseline|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
497991|NCT00762073|B3|Baseline|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
497992|NCT00762073|B2|Baseline|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
497993|NCT00762073|B1|Baseline|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
497994|NCT00762073|P4|Participant Flow|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
497995|NCT00762073|P3|Participant Flow|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
497996|NCT00762073|P2|Participant Flow|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
497997|NCT00762073|P1|Participant Flow|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
497998|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
497999|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498000|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498001|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498002|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498003|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498004|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498005|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498006|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
498007|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
498008|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
498009|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
498010|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
523872|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
498011|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
498012|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
498013|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
498014|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
498015|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
498016|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
498017|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
498018|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498019|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498020|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498021|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498022|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498023|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498024|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498025|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498026|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498027|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498028|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498029|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498030|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498031|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498032|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498033|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498034|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498035|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498036|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498037|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498038|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498529|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
498039|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498040|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498041|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498042|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498043|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498044|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498045|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498046|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498047|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498048|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498049|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498050|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
498051|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
498052|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
498053|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
498054|NCT00762073|E4|Reported Event|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
498055|NCT00762073|E3|Reported Event|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
498056|NCT00762073|E2|Reported Event|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
498057|NCT00762073|E1|Reported Event|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
498058|NCT00762034|B3|Baseline|Total|Total of all reporting groups
498059|NCT00762034|B2|Baseline|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498060|NCT00762034|B1|Baseline|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498061|NCT00762034|P2|Participant Flow|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498103|NCT00762034|O3|Outcome|Pac/Carbo/Bev; Induction Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498062|NCT00762034|P1|Participant Flow|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498063|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498064|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498065|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498066|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498067|NCT00762034|O2|Outcome|TTF-1 Negative (H Score = 0)|"Participants who were TTF-1 Negative (H score = 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
498068|NCT00762034|O1|Outcome|TTF-1 Positive (H Score > 0)|"Participants who were TTF-1 Positive (H score > 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
498069|NCT00762034|O1|Outcome|Pem or Pac Plus Carbo/Bev|"Participants who received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
498070|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498071|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498072|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498178|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498595|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498073|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498074|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498075|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498076|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498077|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498078|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498079|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498080|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498081|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498082|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498114|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498083|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498084|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498085|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498086|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498087|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498088|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498089|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev)followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498090|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498091|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498092|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498196|NCT00761774|B1|Baseline|Brivaracetam|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498530|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
498093|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498094|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498095|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498096|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498097|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498098|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498099|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498100|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498101|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498102|NCT00762034|O4|Outcome|Pac/Carbo/Bev; Maintenance Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498175|NCT00761865|P2|Participant Flow|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498197|NCT00761774|P1|Participant Flow|Brivaracetam|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498104|NCT00762034|O2|Outcome|Pem/Carbo/Bev; Maintenance Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498105|NCT00762034|O1|Outcome|Pem/Carbo/Bev; Induction Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498106|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498107|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498108|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498109|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498110|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498111|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498112|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498113|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498176|NCT00761865|P1|Participant Flow|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498115|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
498116|NCT00762034|E2|Reported Event|Pac/Carbo/Bev|"Induction:~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m ²) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
498117|NCT00762034|E1|Reported Event|Pem/Carbo/Bev|"Induction:~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
498118|NCT00762021|B3|Baseline|Total|Total of all reporting groups
498119|NCT00762021|B2|Baseline|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
498120|NCT00762021|B1|Baseline|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
498121|NCT00762021|P2|Participant Flow|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
498122|NCT00762021|P1|Participant Flow|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
498123|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
498124|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
498125|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
498126|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
498127|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
498128|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
498129|NCT00762021|E2|Reported Event|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
498130|NCT00762021|E1|Reported Event|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
498131|NCT00761969|B3|Baseline|Total|Total of all reporting groups
498132|NCT00761969|B2|Baseline|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498133|NCT00761969|B1|Baseline|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498134|NCT00761969|P2|Participant Flow|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
498135|NCT00761969|P1|Participant Flow|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
498136|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498137|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498177|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
523873|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
498138|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498139|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498140|NCT00761969|E2|Reported Event|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498141|NCT00761969|E1|Reported Event|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
498142|NCT00761956|B3|Baseline|Total|Total of all reporting groups
498143|NCT00761956|B2|Baseline|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
498144|NCT00761956|B1|Baseline|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
498145|NCT00761956|P2|Participant Flow|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
498146|NCT00761956|P1|Participant Flow|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
498147|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
498148|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
498149|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
498150|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
498151|NCT00761956|E2|Reported Event|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
498152|NCT00761956|E1|Reported Event|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
498153|NCT00761930|B4|Baseline|Total|Total of all reporting groups
498154|NCT00761930|B3|Baseline|C - Experimental Toothpaste|fluoride/herbal toothpaste
498155|NCT00761930|B2|Baseline|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
498156|NCT00761930|B1|Baseline|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
498157|NCT00761930|P3|Participant Flow|C - Experimental Toothpaste|fluoride/herbal toothpaste
498158|NCT00761930|P2|Participant Flow|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
498159|NCT00761930|P1|Participant Flow|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
498160|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
498161|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
498162|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
498163|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
498164|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
498165|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
498166|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
498167|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
498168|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
498169|NCT00761930|E3|Reported Event|C - Experimental Toothpaste|fluoride/herbal toothpaste
498170|NCT00761930|E2|Reported Event|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
498171|NCT00761930|E1|Reported Event|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
498172|NCT00761865|B3|Baseline|Total|Total of all reporting groups
498173|NCT00761865|B2|Baseline|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498174|NCT00761865|B1|Baseline|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498179|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498180|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498181|NCT00761865|E2|Reported Event|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498182|NCT00761865|E1|Reported Event|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
498183|NCT00761813|B3|Baseline|Total|Total of all reporting groups
498184|NCT00761813|B2|Baseline|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498185|NCT00761813|B1|Baseline|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498186|NCT00761813|P2|Participant Flow|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498187|NCT00761813|P1|Participant Flow|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498188|NCT00761813|O2|Outcome|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498189|NCT00761813|O1|Outcome|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498190|NCT00761813|O2|Outcome|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498191|NCT00761813|O1|Outcome|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498192|NCT00761813|O2|Outcome|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498193|NCT00761813|O1|Outcome|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498194|NCT00761813|E2|Reported Event|Multiple Cancellous Screws|ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498195|NCT00761813|E1|Reported Event|Single Sliding Hip Screw|Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
498198|NCT00761774|O1|Outcome|Brivaracetam (ES)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498199|NCT00761774|O1|Outcome|Brivaracetam (ES)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498200|NCT00761774|O1|Outcome|Brivaracetam (ES)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498201|NCT00761774|O1|Outcome|Brivaracetam (SS)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498202|NCT00761774|O1|Outcome|Brivaracetam (SS)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200mg/day.
498203|NCT00761774|O1|Outcome|Brivaracetam (SS)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498204|NCT00761774|E1|Reported Event|Brivaracetam (SS)|This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
498205|NCT00761761|B3|Baseline|Total|Total of all reporting groups
498206|NCT00761761|B2|Baseline|Placebo|"Placebo~Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week and will be continued for a total of 8 weeks."
498207|NCT00761761|B1|Baseline|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498208|NCT00761761|P2|Participant Flow|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498209|NCT00761761|P1|Participant Flow|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498210|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498211|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498212|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498213|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498214|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498215|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498216|NCT00761761|O2|Outcome|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498217|NCT00761761|O1|Outcome|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498218|NCT00761761|E2|Reported Event|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498219|NCT00761761|E1|Reported Event|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
498220|NCT00761748|B1|Baseline|Overall Study Population|Urostomy operated subjects
498221|NCT00761748|P2|Participant Flow|ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece|Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.
498222|NCT00761748|P1|Participant Flow|Sensura Uro 2 Piece First, Then Convatec 2 Piece|Sensura is a newly developed two piece product for people with urostomies.
498223|NCT00761748|O2|Outcome|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urin from a stoma.
498224|NCT00761748|O1|Outcome|Sensura Uro 2 Piece|The new SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
498225|NCT00761748|E2|Reported Event|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma.
498226|NCT00761748|E1|Reported Event|Sensura Uro 2 Piece|SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
498227|NCT00761735|B1|Baseline|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498253|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
498228|NCT00761735|P1|Participant Flow|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498229|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (Male)|Male pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498230|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (Female)|Female pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498231|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498232|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498233|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498234|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498235|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498236|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498237|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (All)|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498238|NCT00761735|E1|Reported Event|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
498239|NCT00761631|B5|Baseline|Total|Total of all reporting groups
498240|NCT00761631|B4|Baseline|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
498241|NCT00761631|B3|Baseline|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
498242|NCT00761631|B2|Baseline|13vPnC Group 2 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
498243|NCT00761631|B1|Baseline|13vPnC Group 1 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
498244|NCT00761631|P6|Participant Flow|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
498245|NCT00761631|P5|Participant Flow|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
498246|NCT00761631|P4|Participant Flow|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498247|NCT00761631|P3|Participant Flow|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498248|NCT00761631|P2|Participant Flow|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498249|NCT00761631|P1|Participant Flow|13vPnC Group 1 (Cohort 1)|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498250|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498251|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498252|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
498475|NCT00761202|O2|Outcome|Sodium Hyaluronate|
498476|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
498254|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498255|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498256|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498257|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498258|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498259|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498260|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
498261|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
498262|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498263|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498264|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498265|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498266|NCT00761631|O2|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
498267|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
498268|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
498269|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498270|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498271|NCT00761631|E12|Reported Event|6-Month Follow-up 13vPnC Group 4|6 -Month Follow-up Telephone Contact for participants in Group 4.
498272|NCT00761631|E11|Reported Event|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
498273|NCT00761631|E10|Reported Event|6-Month Follow-up 13vPnC Group 3|6-month follow-up telephone contact for participants in Group 3.
498274|NCT00761631|E9|Reported Event|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
498275|NCT00761631|E8|Reported Event|6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
498276|NCT00761631|E7|Reported Event|6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
498277|NCT00761631|E6|Reported Event|13vPnC Group 2 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498278|NCT00761631|E5|Reported Event|13vPnC Group 1 (Cohort 2) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498279|NCT00761631|E4|Reported Event|13vPnC Group 1 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
498280|NCT00761631|E3|Reported Event|13vPnC Group 2 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498281|NCT00761631|E2|Reported Event|13vPnC Group 1 (Cohort 1) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498282|NCT00761631|E1|Reported Event|13vPnC Group 1 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
498283|NCT00761605|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
498284|NCT00761605|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
498285|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498286|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498287|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498288|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498289|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498290|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498291|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498292|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498293|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498294|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498295|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498296|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498297|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498298|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498477|NCT00761202|O2|Outcome|Sodium Hyaluronate|
498478|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
498479|NCT00761202|O2|Outcome|Sodium Hyaluronate|
498480|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
498299|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498300|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498301|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498302|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498303|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498304|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498305|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498306|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498307|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
498308|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498309|NCT00761605|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
498310|NCT00761592|B3|Baseline|Total|Total of all reporting groups
498311|NCT00761592|B2|Baseline|Botulinum Toxin Type A 150kDa|
498312|NCT00761592|B1|Baseline|Botulinum Toxin Type A 900kDa|
498313|NCT00761592|P2|Participant Flow|Botulinum Toxin Type A 150kDa|
498314|NCT00761592|P1|Participant Flow|Botulinum Toxin Type A 900kDa|
498315|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
498316|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
498317|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
498318|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
498319|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
498320|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
498321|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
498322|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
498323|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
498324|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
498325|NCT00761592|E2|Reported Event|Botulinum Toxin Type A 150kDa|
498326|NCT00761592|E1|Reported Event|Botulinum Toxin Type A 900kDa|
498327|NCT00761579|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
498328|NCT00761579|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
498329|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498481|NCT00761202|O2|Outcome|Sodium Hyaluronate|
498482|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
498483|NCT00761202|E2|Reported Event|Sodium Hyaluronate|
498330|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498331|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498332|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498333|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498334|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498335|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498336|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498337|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498338|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498339|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498340|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498341|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498342|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498343|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498344|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498345|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498484|NCT00761202|E1|Reported Event|Carboxymethylcellulose and Glycerin|
498485|NCT00761189|B1|Baseline|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498346|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498347|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498348|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498349|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498350|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498351|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498352|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498353|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498354|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498355|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498356|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
498357|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
498358|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
498359|NCT00761579|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
498360|NCT00761527|B1|Baseline|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
498361|NCT00761527|P1|Participant Flow|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
498527|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
498362|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
498363|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
498364|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
498365|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
498366|NCT00761527|E1|Reported Event|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
498367|NCT00761514|B1|Baseline|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
498368|NCT00761514|P1|Participant Flow|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
498369|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
498370|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
498371|NCT00761514|E1|Reported Event|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
498372|NCT00761462|B3|Baseline|Total|Total of all reporting groups
498373|NCT00761462|B2|Baseline|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
498374|NCT00761462|B1|Baseline|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
498375|NCT00761462|P2|Participant Flow|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
498376|NCT00761462|P1|Participant Flow|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
498377|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
498378|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
498379|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
498380|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
498381|NCT00761462|E2|Reported Event|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
498382|NCT00761462|E1|Reported Event|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
498383|NCT00761345|B1|Baseline|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
498384|NCT00761345|P1|Participant Flow|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
498385|NCT00761345|O1|Outcome|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
498528|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
498386|NCT00761345|E1|Reported Event|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
498387|NCT00761319|B3|Baseline|Total|Total of all reporting groups
498388|NCT00761319|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
498389|NCT00761319|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
498390|NCT00761319|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
498391|NCT00761319|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
498392|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
498393|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
498394|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
498395|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
498396|NCT00761319|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
498397|NCT00761319|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
498398|NCT00761306|B1|Baseline|Vortioxetine 5 or 10 mg/Day|tablets; orally
498399|NCT00761306|P1|Participant Flow|Vortioxetine 5 or 10 mg/Day|tablets; orally
498400|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
498401|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
498402|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
498403|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
498404|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
498405|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
498406|NCT00761306|E1|Reported Event|Vortioxetine 5 or 10 mg/Day|
498407|NCT00761280|B3|Baseline|Total|Total of all reporting groups
498408|NCT00761280|B2|Baseline|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498409|NCT00761280|B1|Baseline|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498410|NCT00761280|P2|Participant Flow|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498411|NCT00761280|P1|Participant Flow|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498412|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498413|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498414|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498415|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498416|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498417|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498418|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498419|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498420|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498421|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498422|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498423|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498424|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498425|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498426|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498427|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498428|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498429|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498430|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
526164|NCT00699608|O1|Outcome|Placebo|Placebo
498431|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498432|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498433|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498434|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498435|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498436|NCT00761280|E2|Reported Event|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
498437|NCT00761280|E1|Reported Event|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
498438|NCT00761215|B4|Baseline|Total|Total of all reporting groups
498439|NCT00761215|B3|Baseline|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
498440|NCT00761215|B2|Baseline|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
498441|NCT00761215|B1|Baseline|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
498442|NCT00761215|P3|Participant Flow|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
498443|NCT00761215|P2|Participant Flow|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
498444|NCT00761215|P1|Participant Flow|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
498445|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
498446|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
498447|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
498448|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
498449|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
498450|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
498451|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
498452|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
498453|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
498454|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
498455|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
498456|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
498457|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
498458|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
498459|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
498460|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
498461|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
498462|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
498463|NCT00761215|E3|Reported Event|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
498464|NCT00761215|E2|Reported Event|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
498465|NCT00761215|E1|Reported Event|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
498466|NCT00761202|B3|Baseline|Total|Total of all reporting groups
498467|NCT00761202|B2|Baseline|Sodium Hyaluronate|
498468|NCT00761202|B1|Baseline|Carboxymethylcellulose and Glycerin|
498469|NCT00761202|P2|Participant Flow|Sodium Hyaluronate|
498470|NCT00761202|P1|Participant Flow|Carboxymethylcellulose and Glycerin|
498471|NCT00761202|O2|Outcome|Sodium Hyaluronate|
498472|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
498473|NCT00761202|O2|Outcome|Sodium Hyaluronate|
498474|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
498486|NCT00761189|P1|Participant Flow|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498487|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498488|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498489|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498490|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498491|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498492|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498493|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498494|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498495|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498496|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498497|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498498|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498499|NCT00761189|E1|Reported Event|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
498500|NCT00761176|B3|Baseline|Total|Total of all reporting groups
498501|NCT00761176|B2|Baseline|Standard of Care|Standardized wound care is used
498502|NCT00761176|B1|Baseline|Active|The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
498503|NCT00761176|P2|Participant Flow|Active|Provant Therapy Device
498504|NCT00761176|P1|Participant Flow|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
498505|NCT00761176|O2|Outcome|Active Provant Device|"Active Device~The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device."
498506|NCT00761176|O1|Outcome|Standard of Care|Standard of Care will be utilized without the device.
498507|NCT00761176|E2|Reported Event|Active|Provant Therapy Device
498508|NCT00761176|E1|Reported Event|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
498509|NCT00761150|B4|Baseline|Total|Total of all reporting groups
498510|NCT00761150|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
498511|NCT00761150|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
498512|NCT00761150|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
498513|NCT00761150|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
498514|NCT00761150|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
498515|NCT00761150|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
498516|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
498517|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
498518|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
498519|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
498520|NCT00761150|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
498521|NCT00761150|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
498522|NCT00761150|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
498523|NCT00761137|B1|Baseline|All Study Participants|This study was a double-blind, randomized, placebo controlled, two-phased, Latin-square crossover study. Subjects received three single-doses of tropicamide or placebo in random order, with a 7-day washout period.
498524|NCT00761137|P1|Participant Flow|All Participants|subjects randomly received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
498525|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
498526|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
498531|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
498532|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
498533|NCT00761137|E1|Reported Event|All Participants|subjects received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
498534|NCT00761007|B5|Baseline|Total|Total of all reporting groups
498535|NCT00761007|B4|Baseline|Placebo|oral tablet, once daily
498536|NCT00761007|B3|Baseline|Ibodutant 60 mg|oral tablet, once daily
498537|NCT00761007|B2|Baseline|Ibodutant 30 mg|oral tablet, once daily
498538|NCT00761007|B1|Baseline|Ibodutant 10 mg|oral tablet, once daily
498539|NCT00761007|P4|Participant Flow|Placebo|oral tablet, once daily
498540|NCT00761007|P3|Participant Flow|Ibodutant 60 mg|oral tablet, once daily
498541|NCT00761007|P2|Participant Flow|Ibodutant 30 mg|oral tablet, once daily
498542|NCT00761007|P1|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
498543|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
498544|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
498545|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
498546|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
498547|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
498548|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
498549|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
498550|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
498551|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
498552|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
498553|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
498554|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
498555|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
498556|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
498557|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
498558|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
498559|NCT00761007|E4|Reported Event|Placebo|oral tablet, once daily
498560|NCT00761007|E3|Reported Event|Ibodutant 60 mg|oral tablet, once daily
498561|NCT00761007|E2|Reported Event|Ibodutant 30 mg|oral tablet, once daily
498562|NCT00761007|E1|Reported Event|Ibodutant 10 mg|oral tablet, once daily
498563|NCT00760877|B3|Baseline|Total|Total of all reporting groups
498564|NCT00760877|B2|Baseline|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
498565|NCT00760877|B1|Baseline|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498566|NCT00760877|P2|Participant Flow|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
498567|NCT00760877|P1|Participant Flow|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498568|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
498569|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498570|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
498571|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498572|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
498573|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498574|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498575|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
498576|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498577|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
498578|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
498579|NCT00760877|E3|Reported Event|Imatinib Subset That Crossed Over to Nilotinib|Imatinib subset that crossed over to nilotinib
498580|NCT00760877|E2|Reported Event|Imatinib|Imatinib
498581|NCT00760877|E1|Reported Event|Nilotinib|Nilotinib
498582|NCT00760838|B3|Baseline|Total|Total of all reporting groups
498583|NCT00760838|B2|Baseline|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498584|NCT00760838|B1|Baseline|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498585|NCT00760838|P2|Participant Flow|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498586|NCT00760838|P1|Participant Flow|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498587|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498588|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498589|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498590|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498591|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498592|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498593|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498594|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498596|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498597|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498598|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498599|NCT00760838|E2|Reported Event|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
498600|NCT00760838|E1|Reported Event|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
498601|NCT00760747|B3|Baseline|Total|Total of all reporting groups
498602|NCT00760747|B2|Baseline|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498603|NCT00760747|B1|Baseline|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498604|NCT00760747|P2|Participant Flow|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498605|NCT00760747|P1|Participant Flow|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498606|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498607|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498608|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498609|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498610|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498611|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498612|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498613|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498614|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498615|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498616|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498617|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498618|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498619|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498620|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498621|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498622|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498623|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498624|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498625|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498626|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498627|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498628|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498629|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498630|NCT00760747|E2|Reported Event|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
498631|NCT00760747|E1|Reported Event|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
498632|NCT00760669|B1|Baseline|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498633|NCT00760669|P1|Participant Flow|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498634|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498635|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498636|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498637|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498638|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498639|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498661|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498662|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498663|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498640|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498641|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498642|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498643|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498644|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498645|NCT00760669|E1|Reported Event|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
498646|NCT00760617|B4|Baseline|Total|Total of all reporting groups
498647|NCT00760617|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498648|NCT00760617|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498649|NCT00760617|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498650|NCT00760617|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498651|NCT00760617|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498652|NCT00760617|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498653|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498654|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498655|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498656|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498657|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498658|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498659|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498660|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
526165|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
498664|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498665|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498666|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498667|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498668|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498669|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498670|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498671|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498672|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498673|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498674|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498675|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498676|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498677|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498678|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498679|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498680|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498681|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498682|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498683|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498684|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498685|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498686|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498687|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498688|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498689|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498690|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498691|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498692|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498693|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498694|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498695|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498696|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498697|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498698|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498699|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498700|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498701|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498702|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498703|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498704|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498705|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498706|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498707|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498708|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498709|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498710|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498711|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498712|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498713|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498714|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498715|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498716|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498717|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498718|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498719|NCT00760617|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
498720|NCT00760617|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
498721|NCT00760617|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
498722|NCT00760578|B5|Baseline|Total|Total of all reporting groups
498723|NCT00760578|B4|Baseline|Placebo|Microcrystaline cellulose once daily
498724|NCT00760578|B3|Baseline|Pioglitazone|Pioglitazone 45 mg once daily
498725|NCT00760578|B2|Baseline|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
498726|NCT00760578|B1|Baseline|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
498727|NCT00760578|P4|Participant Flow|Placebo|Microcrystaline cellulose once daily
498728|NCT00760578|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg once daily
498729|NCT00760578|P2|Participant Flow|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
498730|NCT00760578|P1|Participant Flow|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
498731|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
498732|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
498733|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
498734|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
498735|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
498736|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
498737|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
498738|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
498739|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
498740|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
498741|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
498742|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
498743|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
498744|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
498745|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
498746|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
498747|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
498748|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
498749|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
498750|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
498751|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
498752|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
498753|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
498754|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
498755|NCT00760578|O4|Outcome|Placebo|Placebo (microcrystalline cellulose) taken once daily for 28 days
498756|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
498757|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
498758|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
498759|NCT00760578|E4|Reported Event|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
498760|NCT00760578|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg once daily
498761|NCT00760578|E2|Reported Event|Placebo|Microcrystaline cellulose once daily
498762|NCT00760578|E1|Reported Event|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
498763|NCT00760552|B3|Baseline|Total|Total of all reporting groups
498764|NCT00760552|B2|Baseline|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
498765|NCT00760552|B1|Baseline|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
498766|NCT00760552|P2|Participant Flow|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
498767|NCT00760552|P1|Participant Flow|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
526166|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
498768|NCT00760552|O2|Outcome|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
498769|NCT00760552|O1|Outcome|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
498770|NCT00760552|E2|Reported Event|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
498771|NCT00760552|E1|Reported Event|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
498772|NCT00760526|B3|Baseline|Total|Total of all reporting groups
498773|NCT00760526|B2|Baseline|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498774|NCT00760526|B1|Baseline|Continuous Glucose Montoring|Treatment group
498775|NCT00760526|P2|Participant Flow|Standard Glucose Monitoring With Home Glucose Meter|Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
498776|NCT00760526|P1|Participant Flow|Continuous Glucose Montoring|Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter >=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
498777|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: CGM Satisfaction
498778|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Blood Glucose Monitoring System Rating Scale
498779|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Blood Glucose Monitoring System Rating Scale
498780|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: PAID
498781|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: PAID
498782|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Hypoglycemia Fear Survey
498783|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Hypoglycemia Fear Survey
498784|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498785|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
498786|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498787|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
498788|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498789|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
498790|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498791|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
498792|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498793|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
498794|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498795|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
498796|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498797|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
498798|NCT00760526|E2|Reported Event|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
498799|NCT00760526|E1|Reported Event|Continuous Glucose Montoring|Treatment group
498800|NCT00760487|B1|Baseline|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
498801|NCT00760487|P1|Participant Flow|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
498802|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
498803|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
498804|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
498805|NCT00760487|E1|Reported Event|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
498861|NCT00760435|E1|Reported Event|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
498806|NCT00760474|B1|Baseline|Entire Study Population|"Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either:~Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58.~Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58."
498807|NCT00760474|P2|Participant Flow|Placebo First, Then Pregabalin|Placebo matching study treatment was administered beginning Period 1/Day9. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.
498808|NCT00760474|P1|Participant Flow|Pregabalin First, Then Placebo|Pregabalin 75 milligrams (mg) by mouth (PO) twice daily (BID) Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38.
498809|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.~Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
498810|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.~Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
498811|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498812|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498813|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498814|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498815|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498816|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498817|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498818|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498819|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498820|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498821|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498822|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498823|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498824|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498825|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498862|NCT00760383|B3|Baseline|Total|Total of all reporting groups
499081|NCT00759772|O2|Outcome|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
498826|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498827|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498828|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498829|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498830|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498831|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498832|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498833|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498834|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498835|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498836|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498837|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498838|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498839|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498840|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498841|NCT00760474|E2|Reported Event|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
498842|NCT00760474|E1|Reported Event|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
498843|NCT00760461|B1|Baseline|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
498844|NCT00760461|P1|Participant Flow|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
498845|NCT00760461|O1|Outcome|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
498846|NCT00760461|E1|Reported Event|Domperidone|Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
498847|NCT00760435|B3|Baseline|Total|Total of all reporting groups
498848|NCT00760435|B2|Baseline|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
498849|NCT00760435|B1|Baseline|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
498850|NCT00760435|P2|Participant Flow|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
498851|NCT00760435|P1|Participant Flow|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
498852|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
498853|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
498854|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
498855|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
498856|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
498857|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
498858|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
498859|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
498860|NCT00760435|E2|Reported Event|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
498863|NCT00760383|B2|Baseline|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
498864|NCT00760383|B1|Baseline|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
498865|NCT00760383|P2|Participant Flow|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
498866|NCT00760383|P1|Participant Flow|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
498867|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
498868|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
498869|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
498870|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
498871|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
498872|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
498873|NCT00760383|E2|Reported Event|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
498874|NCT00760383|E1|Reported Event|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
498875|NCT00760266|B3|Baseline|Total|Total of all reporting groups
498876|NCT00760266|B2|Baseline|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498877|NCT00760266|B1|Baseline|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498878|NCT00760266|P2|Participant Flow|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498879|NCT00760266|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498880|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498881|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498882|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498883|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498884|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498885|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498886|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498887|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498888|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498889|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498890|NCT00760266|E2|Reported Event|HCTZ|HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
498891|NCT00760266|E1|Reported Event|Aliskiren / HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks
498892|NCT00760214|B4|Baseline|Total|Total of all reporting groups
498893|NCT00760214|B3|Baseline|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498894|NCT00760214|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498895|NCT00760214|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498896|NCT00760214|P3|Participant Flow|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498897|NCT00760214|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498898|NCT00760214|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498899|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498900|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498901|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498902|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498903|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498904|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498905|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498906|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498907|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498908|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498909|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498910|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498911|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498912|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498913|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498914|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498915|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498916|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498917|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498918|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498919|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498920|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498921|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498922|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498923|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498924|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498925|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498926|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498927|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498928|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498929|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498930|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498931|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498932|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498933|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498934|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498935|NCT00760214|E3|Reported Event|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
498936|NCT00760214|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
498937|NCT00760214|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
498938|NCT00760084|B1|Baseline|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
498939|NCT00760084|P1|Participant Flow|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
498940|NCT00760084|O1|Outcome|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
498941|NCT00760084|E1|Reported Event|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
498942|NCT00760019|B3|Baseline|Total|Total of all reporting groups
498943|NCT00760019|B2|Baseline|Healthy|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):~The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this control arm, healthy individuals received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
498944|NCT00760019|B1|Baseline|Atherosclerosis or Metabolic Syndrome|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):~The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this arm, individuals with either Metabolic Syndrome or Atherosclerosis received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
498945|NCT00760019|P4|Participant Flow|Healthy Subjects: Placebo First, Then Salsalate|Healthy subjects received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
498946|NCT00760019|P3|Participant Flow|Healthy Subjects: Salsalate First, Then Placebo|Healthy subjects received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
498947|NCT00760019|P2|Participant Flow|Atherosclerosis/Metabolic Syndrome: Placebo First, Then Salsal|Subjects with either Metabolic Syndrome/Atherosclerosis received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
498948|NCT00760019|P1|Participant Flow|Atherosclerosis/Metabolic Syndrome: Salsalate First, Then Plac|Subjects with either Metabolic Syndrome/Atherosclerosis received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
498949|NCT00760019|O2|Outcome|Placebo|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
498950|NCT00760019|O1|Outcome|Salsalate|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
498951|NCT00760019|E2|Reported Event|Placebo|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Placebo
498952|NCT00760019|E1|Reported Event|Salsalate|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Salsalate
498953|NCT00760006|B3|Baseline|Total|Total of all reporting groups
498954|NCT00760006|B2|Baseline|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
499032|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
499033|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
499034|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
526167|NCT00699608|O1|Outcome|Placebo|Placebo
498955|NCT00760006|B1|Baseline|Unasyn Antibiotic Arm|"Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
498956|NCT00760006|P2|Participant Flow|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
498957|NCT00760006|P1|Participant Flow|Unasyn Antibiotic Arm|"Active Comparator: Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
498958|NCT00760006|O2|Outcome|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
498959|NCT00760006|O1|Outcome|Unasyn Antibiotic Arm|"Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
498960|NCT00760006|E2|Reported Event|Saline Placebo Arm|"Other Names:~Salt solution~Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
498961|NCT00760006|E1|Reported Event|Unasyn Antibiotic Arm|"Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.~Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.~Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm"
498962|NCT00759967|B1|Baseline|All Participants|All patients in the study were randomized after the 3 month run in phase to either Conventional HD or Short Daily HD for 3 months and then crossed over to the other treatment arm for 3 months
498963|NCT00759967|P2|Participant Flow|Short Daily Hemodialysis First, Then Conventional Hemodialysis|"After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). Blood pressure was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~In this group 9 participants started and completed the first intervention: Short Daily Hemodialysis first (Period Table 1: Right Column). These 9 participants then started the second intervention: Conventional Hemodialysis (Period Table 2: Right Column). All 9 participants finished conventional dialysis."
498964|NCT00759967|P1|Participant Flow|Conventional Hemodialysis First, Then Short Daily Hemodialysis|"After a 3 month run-in period patients who are randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. BP was monitored according to the Canadian hypertension guidelines both pre and post each dialysis session. Antihypertensive medication were adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period, extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~In this group 10 participants started and completed the first intervention: Conventional Hemodialysis first (Period Table 1; Left Column). These 10 participants then started the second intervention: Short Daily Hemodialysis (Period Table 2: Left Column), of which 8 participants completed the Short Daily Hemodialysis."
498965|NCT00759967|O2|Outcome|Conventional Hemodialysis First, Then Short Daily Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
499035|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
499036|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
499037|NCT00759902|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
498966|NCT00759967|O1|Outcome|Short Daily Hemodialysis First, Then Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498967|NCT00759967|O2|Outcome|Conventional Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498968|NCT00759967|O1|Outcome|Short Daily Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498969|NCT00759967|O2|Outcome|Conventional Hemodialysis First, Then Short Daily Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498970|NCT00759967|O1|Outcome|Short Daily Hemodialysis First, Then Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 month period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498971|NCT00759967|O2|Outcome|Conventional Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498972|NCT00759967|O1|Outcome|Short Daily Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498973|NCT00759967|O2|Outcome|Conventional Hemodialysis|"After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~Below shows the results of the extracellular fluid volume"
498974|NCT00759967|O1|Outcome|Short Daily Hemodialysis|"After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.~Below shows the results of the extracellular fluid volume"
498975|NCT00759967|O2|Outcome|Conventional Hemodialysis|After a 3 month run-in period patients randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498976|NCT00759967|O1|Outcome|Short Daily Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines. At the end of the 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
498977|NCT00759967|E2|Reported Event|Conventional Hemodialysis|After a 3 month run-in period patients who were randomized to this arm received 3 months of conventional hemodialysis 3 days/week 3.5-4 hours/ treatment. SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication was adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress were collected.
499038|NCT00759902|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
498978|NCT00759967|E1|Reported Event|Short Daily Hemodialysis|After a 3 month run-in period patients who are randomized to this arm received 3 months of short daily hemodialysis(2 hours/day,6 days/week). SBP was monitored according to the Canadian hypertension guidelines pre each dialysis session. Antihypertensive medication wer adjusted accordingly to maintain BP within the guidelines.At the end of this 3 moth period extracellular volume was measured using bioimpedance as well as sympathetic nerve activity using microneurography. Additionally Catecholamines as well as markers of oxidative stress will be collected.
498979|NCT00759954|B3|Baseline|Total|Total of all reporting groups
498980|NCT00759954|B2|Baseline|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
498981|NCT00759954|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
498982|NCT00759954|P2|Participant Flow|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
498983|NCT00759954|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
498984|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
498985|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
498986|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
498987|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
498988|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
498989|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
498990|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
498991|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
498992|NCT00759954|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
498993|NCT00759954|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
498994|NCT00759941|B3|Baseline|Total|Total of all reporting groups
498995|NCT00759941|B2|Baseline|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
498996|NCT00759941|B1|Baseline|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
498997|NCT00759941|P2|Participant Flow|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
498998|NCT00759941|P1|Participant Flow|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
498999|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
499000|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
499001|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
499002|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
499003|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
499004|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
499005|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
499006|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
499007|NCT00759941|E2|Reported Event|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
499008|NCT00759941|E1|Reported Event|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
499009|NCT00759915|B3|Baseline|Total|Total of all reporting groups
499010|NCT00759915|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499011|NCT00759915|B1|Baseline|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
499012|NCT00759915|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499013|NCT00759915|P1|Participant Flow|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
499014|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
499015|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
499016|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
499017|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
499018|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
499019|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
499020|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
499021|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
499022|NCT00759915|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
499023|NCT00759915|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
499024|NCT00759902|B3|Baseline|Total|Total of all reporting groups
499025|NCT00759902|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499026|NCT00759902|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
499027|NCT00759902|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499028|NCT00759902|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
499029|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
499030|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
499031|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
499040|NCT00759863|B2|Baseline|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
499041|NCT00759863|B1|Baseline|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
499042|NCT00759863|P2|Participant Flow|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
499043|NCT00759863|P1|Participant Flow|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
499044|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
499045|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
499046|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
499047|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
499048|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
499049|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
499050|NCT00759863|E2|Reported Event|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
499051|NCT00759863|E1|Reported Event|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
499052|NCT00759811|B3|Baseline|Total|Total of all reporting groups
499053|NCT00759811|B2|Baseline|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
499054|NCT00759811|B1|Baseline|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
499055|NCT00759811|P2|Participant Flow|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
499056|NCT00759811|P1|Participant Flow|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
499057|NCT00759811|O2|Outcome|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
499058|NCT00759811|O1|Outcome|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
499059|NCT00759811|E2|Reported Event|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
499060|NCT00759811|E1|Reported Event|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
499061|NCT00759785|B3|Baseline|Total|Total of all reporting groups
499062|NCT00759785|B2|Baseline|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499063|NCT00759785|B1|Baseline|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499064|NCT00759785|P2|Participant Flow|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499065|NCT00759785|P1|Participant Flow|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499066|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499067|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499068|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499069|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499070|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499071|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499072|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499073|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499074|NCT00759785|E2|Reported Event|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499075|NCT00759785|E1|Reported Event|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
499076|NCT00759772|B3|Baseline|Total|Total of all reporting groups
499077|NCT00759772|B2|Baseline|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
499078|NCT00759772|B1|Baseline|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
499079|NCT00759772|P2|Participant Flow|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
499080|NCT00759772|P1|Participant Flow|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
499082|NCT00759772|O1|Outcome|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
499083|NCT00759772|E2|Reported Event|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
499084|NCT00759772|E1|Reported Event|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
499085|NCT00759759|B3|Baseline|Total|Total of all reporting groups
499086|NCT00759759|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499087|NCT00759759|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
499088|NCT00759759|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499089|NCT00759759|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
499090|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
499091|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
499092|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
499093|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
499094|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
499095|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
499096|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
499097|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
499098|NCT00759759|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
499099|NCT00759759|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
499100|NCT00759707|B1|Baseline|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
499101|NCT00759707|P1|Participant Flow|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
499102|NCT00759707|O1|Outcome|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
499103|NCT00759707|E1|Reported Event|Study Population|All 19 study subjects. Each subject qualified for the study on the basis of a continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein.
499104|NCT00759681|B3|Baseline|Total|Total of all reporting groups
499105|NCT00759681|B2|Baseline|Investigational Device|Investigational Treatment: ArterX Surgical Sealant
499106|NCT00759681|B1|Baseline|Control|Control Treatment: Gelfoam and Thrombin
499107|NCT00759681|P2|Participant Flow|Investigational Device: ArterX Surgical Sealant|ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component.
499108|NCT00759681|P1|Participant Flow|Control: Gelfoam and Thrombin|Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade.
499109|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
499110|NCT00759681|O1|Outcome|Control Treatment|Control Treatment with Gelfoam and Thrombin
499111|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
499112|NCT00759681|O1|Outcome|Control Treatment|Control Treatment: Gelfoam and Thrombin
499113|NCT00759681|E2|Reported Event|1. ArterX Surgical Sealant|ArterX Surgical Sealant
499114|NCT00759681|E1|Reported Event|2. Gelfoam and Thrombin|Gelfoam and Thrombin
499115|NCT00759668|B3|Baseline|Total|Total of all reporting groups
499116|NCT00759668|B2|Baseline|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499117|NCT00759668|B1|Baseline|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499118|NCT00759668|P2|Participant Flow|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499119|NCT00759668|P1|Participant Flow|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499120|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499121|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499122|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499123|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499124|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499125|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499126|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499127|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499128|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499129|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499130|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499131|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499132|NCT00759668|E2|Reported Event|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
499133|NCT00759668|E1|Reported Event|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
499134|NCT00759655|B1|Baseline|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499464|NCT00759148|O2|Outcome|Vehicle|Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
499135|NCT00759655|P1|Participant Flow|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499136|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499137|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499138|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499139|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499140|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499141|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499142|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499143|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499144|NCT00759655|E1|Reported Event|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
499145|NCT00759642|B1|Baseline|Lapatinib|"lapatinib~lapatinib: lapatinib 1500 mg PO daily"
499146|NCT00759642|P1|Participant Flow|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)~lapatinib: lapatinib 1500 mg PO daily"
499147|NCT00759642|O1|Outcome|Lapatinib|"lapatinib + Endocrine therapy~lapatinib: lapatinib 1500 mg PO daily"
499148|NCT00759642|E1|Reported Event|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)~lapatinib: lapatinib 1500 mg PO daily"
499149|NCT00759603|B1|Baseline|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
499150|NCT00759603|P1|Participant Flow|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
499151|NCT00759603|O1|Outcome|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
499152|NCT00759603|E1|Reported Event|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
499153|NCT00759577|B1|Baseline|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
499154|NCT00759577|P1|Participant Flow|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
499155|NCT00759577|O1|Outcome|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
499156|NCT00759577|E1|Reported Event|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
499157|NCT00759564|B6|Baseline|Total|Total of all reporting groups
499158|NCT00759564|B5|Baseline|CP-70,429 (200 mg) + PF-03709270: Severe Renal Function|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499159|NCT00759564|B4|Baseline|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499160|NCT00759564|B3|Baseline|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499161|NCT00759564|B2|Baseline|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499162|NCT00759564|B1|Baseline|CP-70,429 (800 mg) + PF-03709270: Normal Renal Impairment|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499187|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499465|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
499163|NCT00759564|P5|Participant Flow|CP-70,429 (200 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499164|NCT00759564|P4|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499165|NCT00759564|P3|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499166|NCT00759564|P2|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499167|NCT00759564|P1|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Normal Renal Function|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
499168|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499169|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499170|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499171|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499172|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499173|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
499174|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499175|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499176|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499177|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499178|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499179|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499180|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499181|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499182|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
499183|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499184|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499185|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499186|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499188|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499189|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499190|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499191|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
499192|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499193|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499194|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499195|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499196|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499197|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499198|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499199|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499200|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
499201|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499202|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499203|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499204|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499205|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499206|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499207|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499208|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499209|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
499210|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499211|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499212|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499213|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499214|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499215|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499216|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499217|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499218|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499219|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499220|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499221|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499222|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499223|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499224|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499225|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499226|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499227|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499228|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499229|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499230|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499231|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499232|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499233|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499234|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499235|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499236|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499237|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499238|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499239|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499240|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499241|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499242|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499243|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499461|NCT00759148|P1|Participant Flow|Moxifloxacin AF|Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
499244|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499245|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499246|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499247|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499248|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499249|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499250|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499251|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499252|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499253|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499254|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499255|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499256|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499257|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499258|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499259|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499260|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499261|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499262|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499263|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499264|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499265|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499266|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499267|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­03709270 1000 mg tablet in second intervention period.
499268|NCT00759564|O1|Outcome|PF­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499269|NCT00759564|O4|Outcome|PF­-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499270|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499271|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499462|NCT00759148|O2|Outcome|Vehicle|Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
499272|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499273|NCT00759564|O4|Outcome|PF-­03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499274|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499275|NCT00759564|O2|Outcome|PF-­03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
499276|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
499277|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499278|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499279|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499280|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499281|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499282|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499283|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499284|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499285|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499286|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499287|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499288|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499289|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499290|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499291|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499292|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499293|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499294|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499295|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499296|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499297|NCT00759564|E9|Reported Event|PF-03709270 (1000 mg): Severe Renal|Participants with severe renal impairment received a single oral dose of PF-03709270 1000 mg tablet under fasted condition in second intervention period.
499298|NCT00759564|E8|Reported Event|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
526168|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
499299|NCT00759564|E7|Reported Event|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499300|NCT00759564|E6|Reported Event|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
499301|NCT00759564|E5|Reported Event|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499302|NCT00759564|E4|Reported Event|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
499303|NCT00759564|E3|Reported Event|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499304|NCT00759564|E2|Reported Event|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499305|NCT00759564|E1|Reported Event|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
499306|NCT00759525|B1|Baseline|All Study Participants|
499307|NCT00759525|P2|Participant Flow|Placebo First, Then Glycyrrhetinic Acid|Placebo followed by Glycyrrhetic Acid-130 mg/day for 14 days
499308|NCT00759525|P1|Participant Flow|Glycyrrhetinic Acid First, Then Placebo|Glycyrrhetic Acid-130 mg/day for 14 days followed by placebo
499309|NCT00759525|O2|Outcome|Placebo|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
499310|NCT00759525|O1|Outcome|Glycyrrhinitic Acid|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
499311|NCT00759525|E2|Reported Event|Placebo First, Then Glycyrrhetinic Acid|Healthy subjects without medical condition.
499312|NCT00759525|E1|Reported Event|Glycyrrhetinic Acid First, Then Placebo|Healthy subjects without medical condition.
499313|NCT00759473|B6|Baseline|Total|Total of all reporting groups
499314|NCT00759473|B5|Baseline|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue expsosure sessions, and at the one-week follow-up session. Participants also received cognitive skills training.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
499315|NCT00759473|B4|Baseline|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
499316|NCT00759473|B3|Baseline|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
499317|NCT00759473|B2|Baseline|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
499318|NCT00759473|B1|Baseline|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
499319|NCT00759473|P5|Participant Flow|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session. Participants also received cognitive skills training. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
499320|NCT00759473|P4|Participant Flow|DCS/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at 2 cue cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
499321|NCT00759473|P3|Participant Flow|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
499322|NCT00759473|P2|Participant Flow|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
499323|NCT00759473|P1|Participant Flow|DCS/DCS/DCS/ Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 3 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
499324|NCT00759473|O5|Outcome|Placebo Plus Cognitive Skills Training|Participants received a placebo at 2 cue extinction sessions and at the one-week follow-up session. Participants also received cognitive skills training.
499325|NCT00759473|O4|Outcome|DCS Plus Cognitive Skills Training|Participants received 50 mg of DCS at 2 cue extinction sessions and placebo at the one-week follow-up session. Participants also received cognitive skills training.
499326|NCT00759473|O3|Outcome|DCS/ Placebo/DCS|Participants received 50 mg of DCS at the 1st and 3rd cue exposure sessions, and placebo at the 2nd cue exposure session and the one-week follow-up session.
499327|NCT00759473|O2|Outcome|Placebo Only|Participants received a placebo at each of 3 cue exposure sessions and at the one-week follow-up session.
499328|NCT00759473|O1|Outcome|DCS Only|Participants received 50 mg of DCS at each of 3 cue exposure sessions and placebo at the one-week follow-up session.
499329|NCT00759473|E5|Reported Event|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session.
499330|NCT00759473|E4|Reported Event|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session.
499331|NCT00759473|E3|Reported Event|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.
499332|NCT00759473|E2|Reported Event|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.
499333|NCT00759473|E1|Reported Event|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.
499334|NCT00759395|B3|Baseline|Total|Total of all reporting groups
499335|NCT00759395|B2|Baseline|Placebo|Placebo BID, Tablet, Oral, Daily
499336|NCT00759395|B1|Baseline|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499337|NCT00759395|P2|Participant Flow|Placebo|Placebo BID, Tablet, Oral, Daily
499338|NCT00759395|P1|Participant Flow|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499339|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
499340|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499341|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
499342|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499343|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
499344|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499345|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
499346|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499347|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
499348|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499349|NCT00759395|E2|Reported Event|Placebo|Placebo BID, Tablet, Oral, Daily
499350|NCT00759395|E1|Reported Event|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
499351|NCT00759356|B3|Baseline|Total|Total of all reporting groups
499352|NCT00759356|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499353|NCT00759356|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
499354|NCT00759356|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
499355|NCT00759356|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
499356|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
499357|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
499358|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
499359|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
499360|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
499361|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
499362|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
499363|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
499364|NCT00759356|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
499365|NCT00759356|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
499366|NCT00759330|B5|Baseline|Total|Total of all reporting groups
499367|NCT00759330|B4|Baseline|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499368|NCT00759330|B3|Baseline|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499369|NCT00759330|B2|Baseline|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499370|NCT00759330|B1|Baseline|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499371|NCT00759330|P4|Participant Flow|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499372|NCT00759330|P3|Participant Flow|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499373|NCT00759330|P2|Participant Flow|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499374|NCT00759330|P1|Participant Flow|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499375|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499376|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499377|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499378|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499379|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499380|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499381|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499382|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499383|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499384|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499385|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499386|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499387|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499388|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499389|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499390|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499391|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499392|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499393|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499394|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499395|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499396|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499397|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499398|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499399|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499400|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499401|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499402|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499403|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499404|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499405|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499406|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499407|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499408|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499409|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499410|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499411|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499412|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499413|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499414|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499415|NCT00759330|E4|Reported Event|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499416|NCT00759330|E3|Reported Event|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
499417|NCT00759330|E2|Reported Event|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
499418|NCT00759330|E1|Reported Event|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
499419|NCT00759187|B4|Baseline|Total|Total of all reporting groups
499420|NCT00759187|B3|Baseline|Chlorhexidine Gluconate|
499421|NCT00759187|B2|Baseline|Fluoride/Triclosan|
499422|NCT00759187|B1|Baseline|Fluoride|
499423|NCT00759187|P3|Participant Flow|Chlorhexidine Gluconate|
499424|NCT00759187|P2|Participant Flow|Fluoride/Triclosan|
499425|NCT00759187|P1|Participant Flow|Fluoride|
499426|NCT00759187|O3|Outcome|Chlorhexidine Gluconate|
499427|NCT00759187|O2|Outcome|Fluoride/Triclosan|
499428|NCT00759187|O1|Outcome|Fluoride|
499429|NCT00759187|E3|Reported Event|Chlorhexidine Gluconate|
499430|NCT00759187|E2|Reported Event|Fluoride/Triclosan|
499431|NCT00759187|E1|Reported Event|Fluoride|
499432|NCT00759174|B3|Baseline|Total|Total of all reporting groups
499433|NCT00759174|B2|Baseline|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
499434|NCT00759174|B1|Baseline|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
499466|NCT00759148|E2|Reported Event|Vehicle|Subjects exposed to Moxifloxacin AF Vehicle
499435|NCT00759174|P2|Participant Flow|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
499436|NCT00759174|P1|Participant Flow|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
499437|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 7 weeks preceding the case window.
499438|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the week preceding the symptom onset day.
499439|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
499440|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
499441|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
499442|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
499443|NCT00759174|E1|Reported Event|Potential NAION Cases|All participants who met pre-defined potential acute NAION criteria and were either exposed or not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
499444|NCT00759161|B1|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499445|NCT00759161|P1|Participant Flow|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499446|NCT00759161|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499447|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499448|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499449|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499450|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499451|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499452|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499453|NCT00759161|O2|Outcome|AN2728 Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499454|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499455|NCT00759161|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499456|NCT00759161|E1|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
499457|NCT00759148|B3|Baseline|Total|Total of all reporting groups
499458|NCT00759148|B2|Baseline|Vehicle|Moxifloxacin AF Vehicle, 1 drop in each eye twice daily for 3 days
499459|NCT00759148|B1|Baseline|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
499460|NCT00759148|P2|Participant Flow|Vehicle|Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
499463|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
499467|NCT00759148|E1|Reported Event|Moxifloxacin AF|Subjects exposed to Moxifloxacin AF
499468|NCT00759109|B3|Baseline|Total|Total of all reporting groups
499469|NCT00759109|B2|Baseline|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499470|NCT00759109|B1|Baseline|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499471|NCT00759109|P2|Participant Flow|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499472|NCT00759109|P1|Participant Flow|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499473|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499474|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499475|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499476|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499477|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499478|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499479|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499480|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499481|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499482|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499483|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499484|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499485|NCT00759109|E2|Reported Event|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
499486|NCT00759109|E1|Reported Event|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
499487|NCT00759096|B1|Baseline|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
499488|NCT00759096|P1|Participant Flow|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
499489|NCT00759096|O1|Outcome|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
499490|NCT00759096|E1|Reported Event|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
499491|NCT00759031|B3|Baseline|Total|Total of all reporting groups
499492|NCT00759031|B2|Baseline|Triclosan + Fluoride 1st, Then Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
499493|NCT00759031|B1|Baseline|Fluoride 1st, Then Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
499494|NCT00759031|P2|Participant Flow|Triclosan + Fluoride 1st, Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
499495|NCT00759031|P1|Participant Flow|Fluoride 1st, Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
499496|NCT00759031|O2|Outcome|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
499497|NCT00759031|O1|Outcome|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
499498|NCT00759031|E2|Reported Event|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
499499|NCT00759031|E1|Reported Event|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
499500|NCT00758836|B5|Baseline|Total|Total of all reporting groups
499501|NCT00758836|B4|Baseline|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
499502|NCT00758836|B3|Baseline|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
499503|NCT00758836|B2|Baseline|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
499504|NCT00758836|B1|Baseline|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
499505|NCT00758836|P4|Participant Flow|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
499506|NCT00758836|P3|Participant Flow|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
499507|NCT00758836|P2|Participant Flow|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
499508|NCT00758836|P1|Participant Flow|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
499509|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
499510|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
499511|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
499512|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
499513|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
499514|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
499515|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
499516|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
499517|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
499518|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
499519|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
499520|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
499521|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
499522|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
499523|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
499524|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
499525|NCT00758836|E4|Reported Event|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
499526|NCT00758836|E3|Reported Event|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
499527|NCT00758836|E2|Reported Event|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
499528|NCT00758836|E1|Reported Event|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
499529|NCT00758771|B3|Baseline|Total|Total of all reporting groups
499530|NCT00758771|B2|Baseline|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
499531|NCT00758771|B1|Baseline|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
499532|NCT00758771|P2|Participant Flow|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
499533|NCT00758771|P1|Participant Flow|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
499534|NCT00758771|O2|Outcome|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
499535|NCT00758771|O1|Outcome|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
499536|NCT00758771|E2|Reported Event|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
499537|NCT00758771|E1|Reported Event|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
499538|NCT00758758|B9|Baseline|Total|Total of all reporting groups
499539|NCT00758758|B8|Baseline|Allograft 2 Levels With Plate|Allograft 2 levels with plate
499540|NCT00758758|B7|Baseline|Autograft 2 Levels With Plate|Autograft 2 levels with plate
499541|NCT00758758|B6|Baseline|Allograft With Plate|Allograft with plate
499542|NCT00758758|B5|Baseline|Autograft With Plate|Autograft with plate
499543|NCT00758758|B4|Baseline|Autograft Only - Illiac Crest|Autograft only - Illiac crest
499544|NCT00758758|B3|Baseline|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
499545|NCT00758758|B2|Baseline|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
499546|NCT00758758|B1|Baseline|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
499547|NCT00758758|P8|Participant Flow|Autograft 2 Levels With Plate|Autograft 2 levels with plate
499548|NCT00758758|P7|Participant Flow|Allograft 2 Levels With Plate|Allograft 2 levels with plate
499549|NCT00758758|P6|Participant Flow|Allograft 1 Level With Plate|Allograft 1 level plated
499550|NCT00758758|P5|Participant Flow|Autograft 1 Level With Plate|Autograft 1 level plated
499551|NCT00758758|P4|Participant Flow|Autograft Only - Illiac Crest|Autograft only - illiac crest
499552|NCT00758758|P3|Participant Flow|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
499553|NCT00758758|P2|Participant Flow|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
499554|NCT00758758|P1|Participant Flow|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
499555|NCT00758758|O8|Outcome|Allograft With 2 Plates|2 Levels with plated Allograft
499556|NCT00758758|O7|Outcome|Autograft With 2 Plates|2 Levels with plated Autograft
499557|NCT00758758|O6|Outcome|Allograft With Plate|Plated Allograft
499558|NCT00758758|O5|Outcome|Autograft With Plate|Plated Autograft
499559|NCT00758758|O4|Outcome|Illiac Crest Autograft|Iliac Crest Autograft
499560|NCT00758758|O3|Outcome|2 Levels Hedrocel With Plate|2 Levels Plated Hedrocel
499561|NCT00758758|O2|Outcome|Hedrocel With Plate|Hedrocel with a plate
499562|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel without plate
499563|NCT00758758|O8|Outcome|2 Levels With Plated Allograft|2 Levels with plated Allograft
499564|NCT00758758|O7|Outcome|2 Levels Plated Autograft|2 Levels with plated Autograft
499565|NCT00758758|O6|Outcome|Plated Allograft|Plated Allograft
499567|NCT00758758|O4|Outcome|Illiac Crest Autograft - no Plate|Iliac Crest Autograft
499568|NCT00758758|O3|Outcome|Two Levels Plated Hedrocel|2 Levels Plated Hedrocel
499569|NCT00758758|O2|Outcome|One Level Hedrocel With Plate|Hedrocel with a plate
499570|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel with out plate
499571|NCT00758758|E8|Reported Event|Allograft 2 Levels With Plate|Allograft 2 levels with plate
499572|NCT00758758|E7|Reported Event|Autograft 2 Levels With Plate|Autograft 2 levels with plate
499573|NCT00758758|E6|Reported Event|Allograft With Plate|Allograft with plate
499574|NCT00758758|E5|Reported Event|Autograft With Plate|Autograft with plate
499575|NCT00758758|E4|Reported Event|Autograft Only - Illiac Crest|Autograft only - Illiac crest
499576|NCT00758758|E3|Reported Event|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
499577|NCT00758758|E2|Reported Event|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
499578|NCT00758758|E1|Reported Event|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
499579|NCT00758745|B3|Baseline|Total|Total of all reporting groups
499580|NCT00758745|B2|Baseline|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
499581|NCT00758745|B1|Baseline|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
499582|NCT00758745|P2|Participant Flow|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
499583|NCT00758745|P1|Participant Flow|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
499584|NCT00758745|O2|Outcome|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
499585|NCT00758745|O1|Outcome|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
499586|NCT00758745|E2|Reported Event|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
499587|NCT00758745|E1|Reported Event|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
499588|NCT00758706|B3|Baseline|Total|Total of all reporting groups
499589|NCT00758706|B2|Baseline|Placebo|Placebo to AZD1236 twice daily(bid)
499590|NCT00758706|B1|Baseline|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499591|NCT00758706|P2|Participant Flow|Placebo|Placebo to AZD1236 twice daily(bid)
499592|NCT00758706|P1|Participant Flow|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499593|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499594|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499595|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499596|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499597|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499598|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499599|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499600|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499601|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499602|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499603|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499604|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499605|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499606|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499607|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499608|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499609|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499610|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499611|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499612|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499613|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499614|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499615|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499616|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499617|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499618|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499619|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499620|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499621|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499622|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499623|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
499624|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499625|NCT00758706|E2|Reported Event|Placebo|Placebo to AZD1236 twice daily(bid)
499626|NCT00758706|E1|Reported Event|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
499627|NCT00758680|B1|Baseline|All Treated Participants|After a 2-week run-in/wash-off period, participants received doses of MK-1006 or matching placebo over a multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
499628|NCT00758680|P10|Participant Flow|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
499629|NCT00758680|P9|Participant Flow|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499630|NCT00758680|P8|Participant Flow|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499631|NCT00758680|P7|Participant Flow|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499632|NCT00758680|P6|Participant Flow|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499633|NCT00758680|P5|Participant Flow|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499634|NCT00758680|P4|Participant Flow|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499635|NCT00758680|P3|Participant Flow|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499636|NCT00758680|P2|Participant Flow|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499637|NCT00758680|P1|Participant Flow|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
499638|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
499639|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499640|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499641|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499642|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499643|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499644|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499645|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499646|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499647|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
499648|NCT00758680|O8|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
499649|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499650|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499651|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499652|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499653|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499654|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499655|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
499656|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
499657|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499658|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499659|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499660|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499661|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499662|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499663|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499664|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499665|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
499666|NCT00758680|E10|Reported Event|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
499667|NCT00758680|E9|Reported Event|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499668|NCT00758680|E8|Reported Event|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
499669|NCT00758680|E7|Reported Event|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499670|NCT00758680|E6|Reported Event|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499671|NCT00758680|E5|Reported Event|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499672|NCT00758680|E4|Reported Event|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499673|NCT00758680|E3|Reported Event|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499674|NCT00758680|E2|Reported Event|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
499675|NCT00758680|E1|Reported Event|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
499676|NCT00758667|B3|Baseline|Total|Total of all reporting groups
499677|NCT00758667|B2|Baseline|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
499678|NCT00758667|B1|Baseline|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
499679|NCT00758667|P2|Participant Flow|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
499680|NCT00758667|P1|Participant Flow|Standard|Standard procedure or capsulectomy for removal of capsule;
499681|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
499682|NCT00758667|O1|Outcome|Standard|Standard procedure or capsulectomy for removal of capsule;
499683|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
499684|NCT00758667|O1|Outcome|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
499685|NCT00758667|E2|Reported Event|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
499686|NCT00758667|E1|Reported Event|Standard|Standard procedure or capsulectomy for removal of capsule;
499687|NCT00758602|B3|Baseline|Total|Total of all reporting groups
499688|NCT00758602|B2|Baseline|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499730|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499731|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499689|NCT00758602|B1|Baseline|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499690|NCT00758602|P2|Participant Flow|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499691|NCT00758602|P1|Participant Flow|Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499692|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499693|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499694|NCT00758602|O2|Outcome|MMFl, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499695|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499696|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499697|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499698|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499699|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499700|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499701|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499732|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499733|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499702|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499703|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499704|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499705|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499706|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499707|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499708|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499709|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499710|NCT00758602|E2|Reported Event|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499711|NCT00758602|E1|Reported Event|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
499712|NCT00758589|B5|Baseline|Total|Total of all reporting groups
499713|NCT00758589|B4|Baseline|Placebo|placebo oral tablet, twice daily
499714|NCT00758589|B3|Baseline|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499715|NCT00758589|B2|Baseline|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499716|NCT00758589|B1|Baseline|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499717|NCT00758589|P4|Participant Flow|Placebo|placebo oral tablet, twice daily
499718|NCT00758589|P3|Participant Flow|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499719|NCT00758589|P2|Participant Flow|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499720|NCT00758589|P1|Participant Flow|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499721|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499722|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499723|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499724|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499725|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499726|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499727|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499728|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499734|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499735|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499736|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499737|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499738|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499739|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499740|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499741|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499742|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499743|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499744|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499745|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499746|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499747|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499748|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499749|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499750|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499751|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499752|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499753|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499754|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499755|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499756|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499757|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499758|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499759|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499760|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499761|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499762|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499763|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499764|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499765|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499766|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499767|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499768|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499769|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499770|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499771|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499772|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499773|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499774|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499775|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499776|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499777|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
499778|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499779|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499780|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499781|NCT00758589|E4|Reported Event|Placebo|placebo oral tablet, twice daily
499782|NCT00758589|E3|Reported Event|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
499783|NCT00758589|E2|Reported Event|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
499784|NCT00758589|E1|Reported Event|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
499785|NCT00758576|B1|Baseline|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
499786|NCT00758576|P1|Participant Flow|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
499787|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
499788|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
499789|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
499790|NCT00758576|E1|Reported Event|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
499791|NCT00758563|B3|Baseline|Total|Total of all reporting groups
499792|NCT00758563|B2|Baseline|Triclosan|
499793|NCT00758563|B1|Baseline|Fluoride|
499794|NCT00758563|P2|Participant Flow|Triclosan|
499795|NCT00758563|P1|Participant Flow|Fluoride|
499796|NCT00758563|O2|Outcome|Triclosan|
499797|NCT00758563|O1|Outcome|Fluoride|
499798|NCT00758550|B3|Baseline|Total|Total of all reporting groups
499799|NCT00758550|B2|Baseline|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
499800|NCT00758550|B1|Baseline|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
499801|NCT00758550|P2|Participant Flow|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
499802|NCT00758550|P1|Participant Flow|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
499803|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
499804|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
499805|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
499806|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
499807|NCT00758550|E2|Reported Event|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
499808|NCT00758550|E1|Reported Event|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
499809|NCT00758498|B4|Baseline|Total|Total of all reporting groups
499810|NCT00758498|B3|Baseline|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499811|NCT00758498|B2|Baseline|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499812|NCT00758498|B1|Baseline|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499813|NCT00758498|P3|Participant Flow|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499814|NCT00758498|P2|Participant Flow|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499815|NCT00758498|P1|Participant Flow|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499816|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499817|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499818|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499819|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499820|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499821|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499822|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499823|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499824|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499825|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499826|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499827|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499828|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499829|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499830|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499831|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499832|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499833|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499834|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499835|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499836|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499837|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499838|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499839|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499840|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499841|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499842|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499843|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499844|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499845|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499846|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499847|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499848|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499849|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499850|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499851|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499852|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499853|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499854|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499855|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499856|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499857|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499858|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499859|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499860|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499861|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499862|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499863|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499864|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499865|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499866|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499867|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499868|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499869|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499870|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499871|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499872|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499873|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499874|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499875|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499876|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499877|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499878|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499879|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499880|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499881|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499882|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499883|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499884|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499885|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499886|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499887|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499888|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499889|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499890|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499891|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499892|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499893|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499894|NCT00758498|E3|Reported Event|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499895|NCT00758498|E2|Reported Event|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499896|NCT00758498|E1|Reported Event|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
499897|NCT00758485|B3|Baseline|Total|Total of all reporting groups
499898|NCT00758485|B2|Baseline|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
499899|NCT00758485|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
499900|NCT00758485|P2|Participant Flow|Placebo|Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499901|NCT00758485|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
499902|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499973|NCT00758342|B1|Baseline|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
499903|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499904|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499905|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499906|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499907|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg/kg-1 Sugammadex at a target depth of NMB of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
499908|NCT00758485|E2|Reported Event|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499909|NCT00758485|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
499910|NCT00758459|B3|Baseline|Total|Total of all reporting groups
499911|NCT00758459|B2|Baseline|Placebo|Placebo
499912|NCT00758459|B1|Baseline|AZD1236|AZD1236
499913|NCT00758459|P2|Participant Flow|Placebo|Placebo
499914|NCT00758459|P1|Participant Flow|AZD1236|AZD1236
499915|NCT00758459|O2|Outcome|Placebo|Placebo
499916|NCT00758459|O1|Outcome|AZD1236|AZD1236
499917|NCT00758459|O2|Outcome|Placebo|Placebo
499918|NCT00758459|O1|Outcome|AZD1236|AZD1236
499919|NCT00758459|O2|Outcome|Placebo|Placebo
499920|NCT00758459|O1|Outcome|AZD1236|AZD1236
499921|NCT00758459|O2|Outcome|Placebo|Placebo
499922|NCT00758459|O1|Outcome|AZD1236|AZD1236
499923|NCT00758459|O2|Outcome|Placebo|Placebo
499924|NCT00758459|O1|Outcome|AZD1236|AZD1236
499925|NCT00758459|O2|Outcome|Placebo|Placebo
499926|NCT00758459|O1|Outcome|AZD1236|AZD1236
499927|NCT00758459|O2|Outcome|Placebo|Placebo
499928|NCT00758459|O1|Outcome|AZD1236|AZD1236
499929|NCT00758459|O2|Outcome|Placebo|Placebo
499930|NCT00758459|O1|Outcome|AZD1236|AZD1236
499931|NCT00758459|O2|Outcome|Placebo|Placebo
499932|NCT00758459|O1|Outcome|AZD1236|AZD1236
499933|NCT00758459|O2|Outcome|Placebo|Placebo
499934|NCT00758459|O1|Outcome|AZD1236|AZD1236
499935|NCT00758459|O2|Outcome|Placebo|Placebo
499936|NCT00758459|O1|Outcome|AZD1236|AZD1236
499937|NCT00758459|O2|Outcome|Placebo|Placebo
499938|NCT00758459|O1|Outcome|AZD1236|AZD1236
499939|NCT00758459|O2|Outcome|Placebo|Placebo
499940|NCT00758459|O1|Outcome|AZD1236|AZD1236
499941|NCT00758459|O2|Outcome|Placebo|Placebo
499942|NCT00758459|O1|Outcome|AZD1236|AZD1236
499943|NCT00758459|E2|Reported Event|Placebo|Placebo
499944|NCT00758459|E1|Reported Event|AZD1236|AZD1236
499945|NCT00758420|B3|Baseline|Total|Total of all reporting groups
499946|NCT00758420|B2|Baseline|Polidocanol Injectable Foam, 1.0%|Polidocanol injectable foam 1%, up to 15 mL, one treatment session
499947|NCT00758420|B1|Baseline|Placebo|Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
499948|NCT00758420|P2|Participant Flow|Placebo|"Agitated saline~Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session"
499949|NCT00758420|P1|Participant Flow|Active Treatment|polidocanol injectiable foam 1%, up to 15 mL, one treatment session
499950|NCT00758420|O2|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
499951|NCT00758420|O1|Outcome|Placebo|agitated saline
499952|NCT00758420|E2|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
499953|NCT00758420|E1|Reported Event|Placebo|agitated saline
499954|NCT00758394|B5|Baseline|Total|Total of all reporting groups
499955|NCT00758394|B4|Baseline|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
499956|NCT00758394|B3|Baseline|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
499957|NCT00758394|B2|Baseline|Fluoride/Triclosan - B|Positive control comparator
499958|NCT00758394|B1|Baseline|Fluoride - A|Negative control
499959|NCT00758394|P4|Participant Flow|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
499960|NCT00758394|P3|Participant Flow|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
499961|NCT00758394|P2|Participant Flow|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
499962|NCT00758394|P1|Participant Flow|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
499963|NCT00758394|O4|Outcome|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
499964|NCT00758394|O3|Outcome|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
499965|NCT00758394|O2|Outcome|Fluoride/Triclosan - B|Positive control comparator
499966|NCT00758394|O1|Outcome|Fluoride - A|Negative control
499967|NCT00758394|E4|Reported Event|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
499968|NCT00758394|E3|Reported Event|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
499969|NCT00758394|E2|Reported Event|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
499970|NCT00758394|E1|Reported Event|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
499971|NCT00758342|B3|Baseline|Total|Total of all reporting groups
499972|NCT00758342|B2|Baseline|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
499974|NCT00758342|P2|Participant Flow|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
499975|NCT00758342|P1|Participant Flow|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
499976|NCT00758342|O2|Outcome|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
499977|NCT00758342|O1|Outcome|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
499978|NCT00758342|E2|Reported Event|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
499979|NCT00758342|E1|Reported Event|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
499980|NCT00758290|B3|Baseline|Total|Total of all reporting groups
499981|NCT00758290|B2|Baseline|Triclosan/Fluoride|
499982|NCT00758290|B1|Baseline|Fluoride/Triclosan|
499983|NCT00758290|P2|Participant Flow|Triclosan/Fluoride|
499984|NCT00758290|P1|Participant Flow|Fluoride/Triclosan|
499985|NCT00758290|O2|Outcome|Triclosan/Fluoride|
499986|NCT00758290|O1|Outcome|Fluoride/Triclosan|
499987|NCT00758264|B4|Baseline|Total|Total of all reporting groups
499988|NCT00758264|B3|Baseline|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499989|NCT00758264|B2|Baseline|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499990|NCT00758264|B1|Baseline|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499991|NCT00758264|P3|Participant Flow|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499992|NCT00758264|P2|Participant Flow|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499993|NCT00758264|P1|Participant Flow|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499994|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499995|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499996|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499997|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499998|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
499999|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500000|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500001|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500002|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500003|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500044|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500004|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500005|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500006|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500007|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500008|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500009|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500010|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500011|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500012|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500013|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500014|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500015|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500016|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500017|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500018|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500019|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500020|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500021|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500022|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500023|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500074|NCT00758069|P2|Participant Flow|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
500024|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500025|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500026|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500027|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500028|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500029|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500030|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500031|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500032|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500033|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500034|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500035|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500036|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500037|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500038|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500039|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500040|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500041|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500042|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500043|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500075|NCT00758069|P1|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
500045|NCT00758264|O3|Outcome|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500046|NCT00758264|O2|Outcome|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500047|NCT00758264|O1|Outcome|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500048|NCT00758264|E3|Reported Event|Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500049|NCT00758264|E2|Reported Event|Nimenrix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500050|NCT00758264|E1|Reported Event|Nimenrix + Synflorix Group|Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
500051|NCT00758160|B1|Baseline|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500052|NCT00758160|P1|Participant Flow|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500053|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500054|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500055|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500056|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500057|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500058|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500059|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500060|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500061|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500062|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500063|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500064|NCT00758160|O1|Outcome|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500065|NCT00758160|E4|Reported Event|OROS MPH-Week 8|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500066|NCT00758160|E3|Reported Event|OROS MPH-Week 4|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500067|NCT00758160|E2|Reported Event|OROS MPH-Week 2|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500068|NCT00758160|E1|Reported Event|OROS MPH-Baseline|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
500069|NCT00758069|B4|Baseline|Total|Total of all reporting groups
500070|NCT00758069|B3|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
500071|NCT00758069|B2|Baseline|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
500072|NCT00758069|B1|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
500073|NCT00758069|P3|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
500076|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
500077|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
500078|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
500079|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
500080|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
500081|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
500082|NCT00758069|E3|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
500083|NCT00758069|E2|Reported Event|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
500084|NCT00758069|E1|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
500085|NCT00758043|B5|Baseline|Total|Total of all reporting groups
500086|NCT00758043|B4|Baseline|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
500087|NCT00758043|B3|Baseline|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
500088|NCT00758043|B2|Baseline|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500089|NCT00758043|B1|Baseline|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500090|NCT00758043|P4|Participant Flow|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
500091|NCT00758043|P3|Participant Flow|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
500092|NCT00758043|P2|Participant Flow|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500093|NCT00758043|P1|Participant Flow|T12PR24 (eRVR+)|Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500094|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
500095|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
500096|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
500097|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
500098|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
500099|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
500100|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500101|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500102|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
500103|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
500104|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
500105|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
500106|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
500107|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
500169|NCT00757822|P1|Participant Flow|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 30-60 min prior start of surgery."
500108|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
500109|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
500110|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
500111|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
500112|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500113|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500114|NCT00758043|E4|Reported Event|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
500115|NCT00758043|E3|Reported Event|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
500116|NCT00758043|E2|Reported Event|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500117|NCT00758043|E1|Reported Event|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
500118|NCT00757848|B3|Baseline|Total|Total of all reporting groups
500119|NCT00757848|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
500120|NCT00757848|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500121|NCT00757848|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
500122|NCT00757848|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500123|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500124|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500125|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500126|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500127|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500128|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500129|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500130|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500131|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500132|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500133|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500134|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500135|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500136|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500137|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500138|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500139|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500140|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500141|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500142|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500143|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500144|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500145|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500146|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500147|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500148|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500149|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500150|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500151|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500152|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500153|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500154|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500155|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500156|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500157|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500158|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500159|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500160|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500161|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
500162|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500163|NCT00757848|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
500164|NCT00757848|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
500165|NCT00757822|B3|Baseline|Total|Total of all reporting groups
500166|NCT00757822|B2|Baseline|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500167|NCT00757822|B1|Baseline|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500168|NCT00757822|P2|Participant Flow|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4 mg) will be administered iv 20-30 min prior to end of surgery in those patients not receiving Dronabinol."
500170|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500171|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500172|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500173|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500174|NCT00757822|O2|Outcome|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500175|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500176|NCT00757822|O2|Outcome|Arm 2: Ondnasetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500177|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500178|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500179|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500180|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500181|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500182|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500183|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500184|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
500185|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
500186|NCT00757822|E2|Reported Event|Ondansetron-control Therapy|Ondansetron (4 mg) was administered iv 20-30 min prior to end of elective abdominal surgery scheduled for same day discharge to home.
500187|NCT00757822|E1|Reported Event|Dronabinol- Experimental Therapy|Dronabinol (5mg) was administered po 30-60 min prior to start of elective abdominal surgery scheduled for same day discharge to home.
500188|NCT00757783|B3|Baseline|Total|Total of all reporting groups
500189|NCT00757783|B2|Baseline|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500190|NCT00757783|B1|Baseline|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500191|NCT00757783|P2|Participant Flow|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500192|NCT00757783|P1|Participant Flow|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500193|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500194|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500195|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500196|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500197|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500198|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500199|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500200|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500201|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500202|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500203|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500204|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500205|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500318|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500206|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500207|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500208|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500209|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500210|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500211|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500212|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500213|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500214|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500215|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500216|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500217|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500218|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500219|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500220|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500221|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500222|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500223|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500224|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500225|NCT00757783|E2|Reported Event|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
500226|NCT00757783|E1|Reported Event|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
500227|NCT00757705|B1|Baseline|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500228|NCT00757705|P1|Participant Flow|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500229|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500230|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500231|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500232|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500233|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500319|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500234|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500235|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500236|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500237|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500238|NCT00757705|E1|Reported Event|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
500239|NCT00757666|B3|Baseline|Total|Total of all reporting groups
500240|NCT00757666|B2|Baseline|Minute Ventilation|Minute ventilation
500241|NCT00757666|B1|Baseline|Accelerometer|Accelerometer
500242|NCT00757666|P2|Participant Flow|Minute Ventilation|Minute ventilation
500243|NCT00757666|P1|Participant Flow|Accelerometer|Accelerometer
500244|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
500245|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
500246|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
500247|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
500248|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
500249|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
500250|NCT00757666|O2|Outcome|Minute Ventilation|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.~Rate adaptive pacemaker: Minute ventilation sensor"
500251|NCT00757666|O1|Outcome|Accelerometer|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.~Rate adaptive pacemaker: Accelerometer sensor"
500252|NCT00757666|O2|Outcome|Accelerometer|
500253|NCT00757666|O1|Outcome|Minute Ventilation|
500254|NCT00757666|E2|Reported Event|Minute Ventilation|Minute ventilation
500255|NCT00757666|E1|Reported Event|Accelerometer|Accelerometer
500256|NCT00757627|B1|Baseline|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
500257|NCT00757627|P1|Participant Flow|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
500258|NCT00757627|O1|Outcome|Etoricoxib 60 mg q.d.|
500259|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
500260|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
500261|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
500262|NCT00757627|O1|Outcome|Week 4 - EQ-5D|
500263|NCT00757627|O1|Outcome|Baseline - EQ-5D|
500264|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
500265|NCT00757627|O1|Outcome|Etoricoxib (Week 4)|Etoricoxib 60 mg q.d.
500266|NCT00757627|O1|Outcome|Etoricoxib (Baseline)|Etoricoxib 60 mg q.d.
500267|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
500268|NCT00757627|E1|Reported Event|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
500269|NCT00757601|B1|Baseline|All Participants|Participants were treated with MK1006 or dose-matched placebo over 5 treatment periods.
500270|NCT00757601|P12|Participant Flow|140mg MK1006/170mg MK1006/200mg MK1006/Placebo/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
500271|NCT00757601|P11|Participant Flow|140mg MK1006/170mg MK1006/Placebo/230mg MK1006/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
500272|NCT00757601|P10|Participant Flow|Placebo/170mg MK1006/200mg MK1006/230mg MK1006/260mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
500273|NCT00757601|P9|Participant Flow|140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo|Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5
500274|NCT00757601|P8|Participant Flow|60 mg MK1006/80 mg MK1006/100 mg MK1006/Placebo/140 mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
500275|NCT00757601|P7|Participant Flow|60mg MK1006/80mg MK1006/Placebo/120mg MK1006/140mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
500276|NCT00757601|P6|Participant Flow|Placebo/80mg MK1006/100mg MK1006/120mg MK1006/140mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
500277|NCT00757601|P5|Participant Flow|60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo|Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
500278|NCT00757601|P4|Participant Flow|15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
500279|NCT00757601|P3|Participant Flow|15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
500280|NCT00757601|P2|Participant Flow|Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)|Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
500281|NCT00757601|P1|Participant Flow|15mg MK1006/Placebo/45mg MK1006/60mg MK1006/Placebo (Fed)|Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
500282|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500283|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500284|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500285|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500286|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500287|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500288|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500289|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500290|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500291|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500292|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500293|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500294|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500295|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
500296|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500297|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500298|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500299|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500300|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500301|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500302|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500303|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500304|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500305|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500306|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500307|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500308|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500309|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500310|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500311|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500312|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500313|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500314|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500315|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500316|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500317|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500320|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500321|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500322|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500323|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500324|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500325|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500326|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500327|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500328|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500329|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500330|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500331|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500332|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500333|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500334|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500335|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500336|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500337|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500338|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500339|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500340|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500341|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500342|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500343|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500344|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500345|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500346|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500347|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500348|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500349|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500350|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500351|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500352|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500353|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500354|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500355|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500356|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500357|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500358|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500359|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500360|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500361|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
500362|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500363|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500364|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500365|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500366|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500367|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500368|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500369|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500370|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500371|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500372|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500373|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500374|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500375|NCT00757601|E14|Reported Event|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
500376|NCT00757601|E13|Reported Event|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
500377|NCT00757601|E12|Reported Event|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
500378|NCT00757601|E11|Reported Event|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
500379|NCT00757601|E10|Reported Event|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
500380|NCT00757601|E9|Reported Event|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
500381|NCT00757601|E8|Reported Event|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
500382|NCT00757601|E7|Reported Event|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
500383|NCT00757601|E6|Reported Event|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
500384|NCT00757601|E5|Reported Event|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
500385|NCT00757601|E4|Reported Event|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
500386|NCT00757601|E3|Reported Event|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
500387|NCT00757601|E2|Reported Event|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
500388|NCT00757601|E1|Reported Event|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
500389|NCT00757588|B3|Baseline|Total|Total of all reporting groups
500390|NCT00757588|B2|Baseline|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500391|NCT00757588|B1|Baseline|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500392|NCT00757588|P2|Participant Flow|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500393|NCT00757588|P1|Participant Flow|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500394|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500395|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500396|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500397|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500398|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500399|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500400|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500401|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500402|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
501231|NCT00754793|E1|Reported Event|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
500403|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500404|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500405|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500406|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500407|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500408|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500409|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500410|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500411|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500412|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500413|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500414|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500415|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500416|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500417|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500418|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500419|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500420|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500421|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500422|NCT00757588|E2|Reported Event|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
500423|NCT00757588|E1|Reported Event|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
500424|NCT00757484|B1|Baseline|Women Who Underwent Gyneologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
500425|NCT00757484|P1|Participant Flow|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
500426|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
500427|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
500428|NCT00757484|O1|Outcome|Women Who Underwent GYN Surgery|All women who underwent inpatient GYN surgery between Jan 2007 and 2008.
500429|NCT00757484|O1|Outcome|Women Who Underwent Scheduled Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
500430|NCT00757484|E1|Reported Event|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient gynecologic surgery between Jan 2007 and 2008.
500431|NCT00757237|B3|Baseline|Total|Total of all reporting groups
500432|NCT00757237|B2|Baseline|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500433|NCT00757237|B1|Baseline|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500434|NCT00757237|P2|Participant Flow|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500435|NCT00757237|P1|Participant Flow|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500436|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500437|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500438|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500515|NCT00756938|B3|Baseline|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
501232|NCT00754767|B3|Baseline|Total|Total of all reporting groups
500439|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500440|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500441|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500442|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500443|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500444|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500445|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500446|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500447|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500448|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500449|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500450|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500451|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500452|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500453|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500454|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500455|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500456|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500457|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500458|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500459|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500460|NCT00757237|E2|Reported Event|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
500461|NCT00757237|E1|Reported Event|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
500462|NCT00757172|B1|Baseline|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
500463|NCT00757172|P1|Participant Flow|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
500464|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
526169|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
500465|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
500466|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
500467|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
500468|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
500469|NCT00757172|E1|Reported Event|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
500470|NCT00757003|B1|Baseline|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
500471|NCT00757003|P1|Participant Flow|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
500472|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
500473|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta~Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
500474|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
500475|NCT00757003|E1|Reported Event|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta~Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
500476|NCT00756977|B3|Baseline|Total|Total of all reporting groups
500477|NCT00756977|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
500478|NCT00756977|B1|Baseline|BLI850|
500479|NCT00756977|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Single administration oral preparation
500480|NCT00756977|P1|Participant Flow|BLI850|Single administration oral preparation
500481|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500482|NCT00756977|O1|Outcome|BLI850|
500483|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500484|NCT00756977|O1|Outcome|BLI850|
500485|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500486|NCT00756977|O1|Outcome|BLI850|
500487|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500488|NCT00756977|O1|Outcome|BLI850|
500489|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500490|NCT00756977|O1|Outcome|BLI850|
500491|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500492|NCT00756977|O1|Outcome|BLI850|
500493|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500494|NCT00756977|O1|Outcome|BLI850|
500495|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500496|NCT00756977|O1|Outcome|BLI850|
500497|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500498|NCT00756977|O1|Outcome|BLI850|
500499|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500500|NCT00756977|O1|Outcome|BLI850|
500501|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500502|NCT00756977|O1|Outcome|BLI850|
500503|NCT00756977|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
500504|NCT00756977|E1|Reported Event|BLI850|
500505|NCT00756964|B3|Baseline|Total|Total of all reporting groups
500506|NCT00756964|B2|Baseline|Placebo Group|This group received an identical placebo of rasburicase.
500507|NCT00756964|B1|Baseline|Rasburicase Group|The drug rasburicase was used in this group.
500508|NCT00756964|P2|Participant Flow|Placebo Group|This group received an identical placebo of rasburicase.
500509|NCT00756964|P1|Participant Flow|Rasburicase Group|The drug rasburicase was used in this group.
500510|NCT00756964|O2|Outcome|Placebo Group|The patients which received a placebo identical to rasburicase.
500511|NCT00756964|O1|Outcome|Rasburicase Group|The patients received the drug rasburicase 7.5mg in 50mL of normal saline over 30 minutes period
500512|NCT00756964|E2|Reported Event|Placebo Group|This group received an identical placebo of rasburicase.
500513|NCT00756964|E1|Reported Event|Rasburicase Group|The drug rasburicase was used in this group.
500514|NCT00756938|B4|Baseline|Total|Total of all reporting groups
500611|NCT00756548|P1|Participant Flow|BLI850|single administration oral preparation - split dose
500516|NCT00756938|B2|Baseline|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
500517|NCT00756938|B1|Baseline|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
500518|NCT00756938|P4|Participant Flow|Losartan Potassium-Extension|Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
500519|NCT00756938|P3|Participant Flow|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
500520|NCT00756938|P2|Participant Flow|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
500521|NCT00756938|P1|Participant Flow|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
500522|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
500523|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
500524|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
500525|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
500526|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
500527|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
500528|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
500529|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
500530|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
500531|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
500532|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
500533|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
500534|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
500535|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
500536|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
500537|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
500538|NCT00756938|E8|Reported Event|Extension-Losartan 1.4 mg/kg/Day|
500539|NCT00756938|E7|Reported Event|Extension-Losartan 0.7 mg/kg/Day|
500540|NCT00756938|E6|Reported Event|Extension-Losartan 0.3 mg/kg/Day|
500541|NCT00756938|E5|Reported Event|Extension-Losartan 0.1 mg/kg/Day|
500542|NCT00756938|E4|Reported Event|Base Study-Losartan 1.4 mg/kg/Day|
500543|NCT00756938|E3|Reported Event|Base Study-Losartan Potassium 0.7 mg/kg/Day|
500544|NCT00756938|E2|Reported Event|Base Study-Losartan Potassium 0.3 mg/kg/Day|
500545|NCT00756938|E1|Reported Event|Base Study-Losartan Potassium 0.1 mg/kg/Day|
500546|NCT00756886|B3|Baseline|Total|Total of all reporting groups
500547|NCT00756886|B2|Baseline|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500548|NCT00756886|B1|Baseline|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500549|NCT00756886|P2|Participant Flow|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500550|NCT00756886|P1|Participant Flow|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500551|NCT00756886|O2|Outcome|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500552|NCT00756886|O1|Outcome|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500553|NCT00756886|E2|Reported Event|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500554|NCT00756886|E1|Reported Event|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
500555|NCT00756730|B3|Baseline|Total|Total of all reporting groups
500556|NCT00756730|B2|Baseline|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500557|NCT00756730|B1|Baseline|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500558|NCT00756730|P2|Participant Flow|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500559|NCT00756730|P1|Participant Flow|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500560|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500561|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500562|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500563|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500564|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500565|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500566|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500567|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500568|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500569|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500570|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500571|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500572|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500573|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500574|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500575|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500576|NCT00756730|E2|Reported Event|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
500577|NCT00756730|E1|Reported Event|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
500578|NCT00756678|B1|Baseline|All Patients|All patients
500579|NCT00756678|P1|Participant Flow|All Patients|All patients
500580|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
500581|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
500582|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
500583|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
500584|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
500585|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
500586|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
500587|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
500588|NCT00756678|E1|Reported Event|All Patients|All patients
500589|NCT00756574|B3|Baseline|Total|Total of all reporting groups
500590|NCT00756574|B2|Baseline|2. N95 Respirator|N95 respirator
500591|NCT00756574|B1|Baseline|1. Surgical|surgical mask
500592|NCT00756574|P2|Participant Flow|2. N95 Respirator|N95 respirator
500593|NCT00756574|P1|Participant Flow|1. Surgical|surgical mask
500594|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
500595|NCT00756574|O1|Outcome|1. Surgical|surgical mask
500596|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
500597|NCT00756574|O1|Outcome|1. Surgical|surgical mask
500598|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
500599|NCT00756574|O1|Outcome|1. Surgical|surgical mask
500600|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
500601|NCT00756574|O1|Outcome|1. Surgical|surgical mask
500602|NCT00756561|B1|Baseline|Healthy Normal Males|Men, 18-50 years of age, in good health
500603|NCT00756561|P1|Participant Flow|Healthy Normal Males|Men, 18-50 years of age, in good health
500604|NCT00756561|O2|Outcome|Serum Concentration|Serum hormone concentration in 10 normal men
500605|NCT00756561|O1|Outcome|Intratesticular Concentration|Average intratesticular hormone concentration between right and left testis in 10 normal men
500606|NCT00756561|E1|Reported Event|Healthy Normal Males|Men, 18-50 years of age, in good health
500607|NCT00756548|B3|Baseline|Total|Total of all reporting groups
500608|NCT00756548|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
500609|NCT00756548|B1|Baseline|BLI850|
500610|NCT00756548|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|single administration oral preparation - split dose
500612|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500613|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500614|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500615|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500616|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500617|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500618|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500619|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500620|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500621|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500622|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500623|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500624|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500625|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500626|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500627|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500628|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500629|NCT00756548|O1|Outcome|BLI850|
500630|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
500631|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
500632|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
500633|NCT00756548|O1|Outcome|BLI850|
500634|NCT00756548|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
500635|NCT00756548|E1|Reported Event|BLI850|
500636|NCT00756470|B1|Baseline|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
500637|NCT00756470|P1|Participant Flow|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
500638|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
500639|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
500640|NCT00756470|E1|Reported Event|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
500641|NCT00756457|B3|Baseline|Total|Total of all reporting groups
500642|NCT00756457|B2|Baseline|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
500643|NCT00756457|B1|Baseline|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
500644|NCT00756457|P2|Participant Flow|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
500645|NCT00756457|P1|Participant Flow|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
500646|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
526170|NCT00699608|O1|Outcome|Placebo|Placebo
500647|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
500648|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
500649|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
500650|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
500651|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
500652|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
500653|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
500654|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
500655|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
500656|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
500657|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
500658|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
500659|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
500660|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
500661|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
500662|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
500663|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
500664|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
500665|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
500666|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
500667|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
500668|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
500669|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
500670|NCT00756457|E2|Reported Event|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
500671|NCT00756457|E1|Reported Event|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
500672|NCT00756444|B3|Baseline|Total|Total of all reporting groups
500673|NCT00756444|B2|Baseline|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500674|NCT00756444|B1|Baseline|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500900|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500675|NCT00756444|P2|Participant Flow|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500676|NCT00756444|P1|Participant Flow|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500677|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500678|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500679|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500680|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500681|NCT00756444|E3|Reported Event|Total|
500682|NCT00756444|E2|Reported Event|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500683|NCT00756444|E1|Reported Event|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
500684|NCT00756314|B3|Baseline|Total|Total of all reporting groups
500685|NCT00756314|B2|Baseline|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500686|NCT00756314|B1|Baseline|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500687|NCT00756314|P2|Participant Flow|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500688|NCT00756314|P1|Participant Flow|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500689|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500690|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500691|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500692|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500693|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500694|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500695|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500696|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500697|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500698|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500779|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500699|NCT00756314|E2|Reported Event|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
500700|NCT00756314|E1|Reported Event|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
500701|NCT00756275|B3|Baseline|Total|Total of all reporting groups
500702|NCT00756275|B2|Baseline|Varenicline + PLA Patch|"varenicline: Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day.~Pl"
500703|NCT00756275|B1|Baseline|Nicotine Replacement + PLA Pill|"Nicotine Replacement Treatment (NRT): Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3"
500704|NCT00756275|P2|Participant Flow|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~varenicline: Varenicline (VAR, 2mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500705|NCT00756275|P1|Participant Flow|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use: 21mg/day for 4 weeks, 14mg/day for 4 weeks, 7mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500706|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500707|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500708|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500709|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500710|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500711|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500712|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500713|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500714|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500715|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500737|NCT00756236|O1|Outcome|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
500738|NCT00756236|E3|Reported Event|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
500716|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500717|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500718|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500719|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500720|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500721|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500722|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500739|NCT00756236|E2|Reported Event|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
500780|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500723|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500724|NCT00756275|O2|Outcome|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500725|NCT00756275|O1|Outcome|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500726|NCT00756275|E2|Reported Event|Varenicline + PLA Patch|"Varenicline plus matched placebo patches containing no nicotine~Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500727|NCT00756275|E1|Reported Event|Nicotine Replacement + PLA Pill|"Nicotine replacement treatment (NRT) patch plus matched placebo pill~NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks.~Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day."
500728|NCT00756236|B4|Baseline|Total|Total of all reporting groups
500729|NCT00756236|B3|Baseline|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
500730|NCT00756236|B2|Baseline|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
500731|NCT00756236|B1|Baseline|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
500732|NCT00756236|P3|Participant Flow|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
500733|NCT00756236|P2|Participant Flow|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
500734|NCT00756236|P1|Participant Flow|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
500735|NCT00756236|O3|Outcome|P-Group|"Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml & 5ml syringes.~P-Group: 0.9%NaCl dispensed in 60ml & 5ml syringes"
500736|NCT00756236|O2|Outcome|E-Group|"Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.~Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl"
500740|NCT00756236|E1|Reported Event|M-Group|"Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml & 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.~Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration"
500741|NCT00756093|B1|Baseline|Overall Study|
500742|NCT00756093|P4|Participant Flow|GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears|Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last
500743|NCT00756093|P3|Participant Flow|Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive|Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last
500744|NCT00756093|P2|Participant Flow|Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane|Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane
500745|NCT00756093|P1|Participant Flow|Systane, Then Optive, Then Blink Tears, Then GenTeal Moderate|Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.
500746|NCT00756093|O4|Outcome|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
500747|NCT00756093|O3|Outcome|Blink Tears|Blink Tears
500748|NCT00756093|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
500749|NCT00756093|O1|Outcome|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
500750|NCT00756093|E4|Reported Event|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
500751|NCT00756093|E3|Reported Event|Blink Tears|Blink Tears
500752|NCT00756093|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
500753|NCT00756093|E1|Reported Event|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
500754|NCT00756002|B3|Baseline|Total|Total of all reporting groups
500755|NCT00756002|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500756|NCT00756002|B1|Baseline|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500757|NCT00756002|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500758|NCT00756002|P1|Participant Flow|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500759|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500760|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500761|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500762|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500763|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500764|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500765|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500766|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500767|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500768|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500769|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500770|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500771|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500772|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500773|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500774|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500775|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500776|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500777|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500778|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500781|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500782|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500783|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500784|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500785|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500786|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500787|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500788|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500789|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500790|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500791|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500792|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500793|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500794|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500795|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500796|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500797|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500798|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500799|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500800|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500801|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500802|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500803|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500804|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500805|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500806|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500807|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500808|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500809|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500810|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500811|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500812|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500813|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500814|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500815|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500816|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500817|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500818|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500819|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500820|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500821|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500822|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500823|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500824|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500825|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500826|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500827|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500828|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500829|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500830|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500831|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500832|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500833|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500834|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500835|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500836|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500837|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500838|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500839|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500840|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500841|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500842|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500843|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500844|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500845|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500846|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500847|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500848|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500849|NCT00756002|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
500850|NCT00756002|E1|Reported Event|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
500851|NCT00755937|B1|Baseline|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500852|NCT00755937|P1|Participant Flow|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500853|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500854|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500855|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500856|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500857|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500858|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500859|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
500860|NCT00755937|E1|Reported Event|Subjects Receiving Remicade|
500861|NCT00755911|B3|Baseline|Total|Total of all reporting groups
500862|NCT00755911|B2|Baseline|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
500863|NCT00755911|B1|Baseline|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
500864|NCT00755911|P2|Participant Flow|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
500865|NCT00755911|P1|Participant Flow|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
500866|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
500867|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
500868|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
500869|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
500870|NCT00755911|E2|Reported Event|Sham Comparator: Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
500871|NCT00755911|E1|Reported Event|Experimental: Tissue Repair Cell (TRC)|Subjects will receive TRC therapy plus Gelfoam carrier
500872|NCT00755846|B7|Baseline|Total|Total of all reporting groups
500873|NCT00755846|B6|Baseline|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500874|NCT00755846|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500875|NCT00755846|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500876|NCT00755846|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500877|NCT00755846|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500878|NCT00755846|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500879|NCT00755846|P6|Participant Flow|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500880|NCT00755846|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500881|NCT00755846|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500882|NCT00755846|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500883|NCT00755846|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500884|NCT00755846|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500885|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500886|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500887|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500888|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500889|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500890|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500891|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500892|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500893|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500894|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500895|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500896|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500897|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500898|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500899|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
501307|NCT00754624|E1|Reported Event|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
500901|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500902|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500903|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500904|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500905|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500906|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500907|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500908|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500909|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500910|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500911|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500912|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500913|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500914|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500915|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500916|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500917|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500918|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500919|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500920|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500921|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500922|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500923|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500924|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500925|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500926|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500927|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500928|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500929|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500930|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500931|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500932|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500933|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500934|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500935|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500936|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500937|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500938|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500939|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500940|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500941|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500942|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500943|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500944|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500945|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500946|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500947|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500948|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500949|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500950|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500951|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500952|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500953|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500954|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500955|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500956|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500957|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500958|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500959|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500960|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500961|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500962|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500963|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500964|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500965|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500966|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500967|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500968|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500969|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500970|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500971|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500972|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500973|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500974|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500975|NCT00755846|E6|Reported Event|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
500976|NCT00755846|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
500977|NCT00755846|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
500978|NCT00755846|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
500979|NCT00755846|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
500980|NCT00755846|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
500981|NCT00755807|B3|Baseline|Total|Total of all reporting groups
500982|NCT00755807|B2|Baseline|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
500983|NCT00755807|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
500984|NCT00755807|P2|Participant Flow|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
500985|NCT00755807|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
500986|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
500987|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
500988|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
500989|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500990|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500991|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500992|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500993|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
500994|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500995|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500996|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
501555|NCT00754130|B4|Baseline|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
500997|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500998|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
500999|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
501000|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
501001|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
501002|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501003|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501004|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501005|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501006|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501007|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501008|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501009|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501010|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501011|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501012|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501013|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501014|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501015|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501016|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501017|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501018|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501019|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501020|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501021|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501022|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501023|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501024|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501025|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501026|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501556|NCT00754130|B3|Baseline|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
501027|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501028|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501029|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501030|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501031|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501032|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501033|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501034|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
501035|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501036|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501037|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501038|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501039|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501040|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
501041|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
501042|NCT00755807|E3|Reported Event|Duloxetine - Open-label Extension Phase|Participants previously receiving duloxetine or placebo in the double-blind acute phase received duloxetine 60, 90, or 120 mg QD for 12 weeks (open label extension phase)
501043|NCT00755807|E2|Reported Event|Placebo - Double-Blind Acute Phase|Oral, QD for 6 weeks
501044|NCT00755807|E1|Reported Event|Duloxetine - Double-Blind Acute Phase|60 mg oral (po), once daily (QD) for 6 weeks (acute phase)
501045|NCT00755755|B4|Baseline|Total|Total of all reporting groups
501046|NCT00755755|B3|Baseline|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501047|NCT00755755|B2|Baseline|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501048|NCT00755755|B1|Baseline|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501049|NCT00755755|P3|Participant Flow|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501050|NCT00755755|P2|Participant Flow|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501051|NCT00755755|P1|Participant Flow|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501052|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501053|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501054|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501055|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501056|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501057|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501058|NCT00755755|E3|Reported Event|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501059|NCT00755755|E2|Reported Event|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501060|NCT00755755|E1|Reported Event|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
501061|NCT00755716|B4|Baseline|Total|Total of all reporting groups
501062|NCT00755716|B3|Baseline|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
501063|NCT00755716|B2|Baseline|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
501064|NCT00755716|B1|Baseline|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill): patients receive"
501065|NCT00755716|P3|Participant Flow|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
501551|NCT00754156|E1|Reported Event|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
501066|NCT00755716|P2|Participant Flow|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
501067|NCT00755716|P1|Participant Flow|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill):"
501068|NCT00755716|O3|Outcome|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
501069|NCT00755716|O2|Outcome|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
501070|NCT00755716|O1|Outcome|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill): patients receive"
501071|NCT00755716|O3|Outcome|Topiramate and Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
501072|NCT00755716|O2|Outcome|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
501073|NCT00755716|O1|Outcome|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill): patients receive"
501074|NCT00755716|E3|Reported Event|Topiramate & Nicotine Patch|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
501075|NCT00755716|E2|Reported Event|Topiramate|Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.
501076|NCT00755716|E1|Reported Event|Placebo (Sugar Pill)|"Person receives an inactive placebo~Placebo (sugar pill): patients receive"
501077|NCT00755417|B4|Baseline|Total|Total of all reporting groups
501078|NCT00755417|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
501079|NCT00755417|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
501080|NCT00755417|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
501081|NCT00755417|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
501082|NCT00755417|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
501083|NCT00755417|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
501084|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
501085|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
501086|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
501087|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
501088|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
501089|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
501090|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
501091|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
501092|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
501093|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
501094|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
501095|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
501096|NCT00755417|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
501097|NCT00755417|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
501098|NCT00755417|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
501099|NCT00755274|B3|Baseline|Total|Total of all reporting groups
501100|NCT00755274|B2|Baseline|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501101|NCT00755274|B1|Baseline|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501102|NCT00755274|P2|Participant Flow|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501103|NCT00755274|P1|Participant Flow|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501104|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501105|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501233|NCT00754767|B2|Baseline|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
501106|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501107|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501108|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501109|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501110|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501111|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501112|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501113|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501114|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501115|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501116|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501117|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501118|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501119|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501120|NCT00755274|E2|Reported Event|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
501121|NCT00755274|E1|Reported Event|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
501122|NCT00755261|B1|Baseline|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
501123|NCT00755261|P1|Participant Flow|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
501124|NCT00755261|O1|Outcome|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
501150|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501234|NCT00754767|B1|Baseline|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
501125|NCT00755261|E1|Reported Event|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
501126|NCT00755235|B3|Baseline|Total|Total of all reporting groups
501127|NCT00755235|B2|Baseline|Usual Care|Participants will receive their usual care, with no additional education or care management services.
501128|NCT00755235|B1|Baseline|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
501129|NCT00755235|P2|Participant Flow|Usual Care|Participants will receive their usual care, with no additional education or care management services.
501130|NCT00755235|P1|Participant Flow|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
501131|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
501132|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
501133|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
501134|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
501135|NCT00755235|E2|Reported Event|Usual Care|Participants will receive their usual care, with no additional education or care management services.
501136|NCT00755235|E1|Reported Event|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
501137|NCT00755222|B3|Baseline|Total|Total of all reporting groups
501138|NCT00755222|B2|Baseline|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501139|NCT00755222|B1|Baseline|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501140|NCT00755222|P2|Participant Flow|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501141|NCT00755222|P1|Participant Flow|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501142|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501143|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501144|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501145|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501146|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501147|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501148|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501149|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501189|NCT00755079|P1|Participant Flow|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
501151|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501152|NCT00755222|E2|Reported Event|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501153|NCT00755222|E1|Reported Event|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
501154|NCT00755196|B1|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
501155|NCT00755196|P1|Participant Flow|AN2728 5 Percent (%) Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
501156|NCT00755196|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment­ targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
501157|NCT00755196|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
501158|NCT00755196|E1|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
501159|NCT00755131|B3|Baseline|Total|Total of all reporting groups
501160|NCT00755131|B2|Baseline|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
501161|NCT00755131|B1|Baseline|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
501162|NCT00755131|P2|Participant Flow|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
501163|NCT00755131|P1|Participant Flow|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
501164|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
501165|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
501166|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
501167|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
501168|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
501169|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
501170|NCT00755131|E2|Reported Event|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
501171|NCT00755131|E1|Reported Event|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
501172|NCT00755105|B4|Baseline|Total|Total of all reporting groups
501173|NCT00755105|B3|Baseline|Postmenopausal Women Having Consumed Iron-55 Tracer|
501174|NCT00755105|B2|Baseline|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
501175|NCT00755105|B1|Baseline|Male Subjects Having Consumed Iron-55 Tracer|
501176|NCT00755105|P3|Participant Flow|Postmenopausal Women Having Consumed Iron-55 Tracer|
501177|NCT00755105|P2|Participant Flow|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
501178|NCT00755105|P1|Participant Flow|Male Subjects Having Consumed Iron-55 Tracer|
501179|NCT00755105|O3|Outcome|Postmenopausal Women Having Consumed Iron-55 Tracer|
501180|NCT00755105|O2|Outcome|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
501181|NCT00755105|O1|Outcome|Male Subjects Having Consumed Iron-55 Tracer|
501182|NCT00755105|E3|Reported Event|Postmenopausal Women Having Consumed Iron-55 Tracer|
501183|NCT00755105|E2|Reported Event|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
501184|NCT00755105|E1|Reported Event|Male Subjects Having Consumed Iron-55 Tracer|
501185|NCT00755079|B3|Baseline|Total|Total of all reporting groups
501186|NCT00755079|B2|Baseline|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
501187|NCT00755079|B1|Baseline|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
501188|NCT00755079|P2|Participant Flow|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
501229|NCT00754793|O1|Outcome|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
501230|NCT00754793|E2|Reported Event|Placebo|Placebo drug
501190|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
501191|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
501192|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
501193|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
501194|NCT00755079|E2|Reported Event|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
501195|NCT00755079|E1|Reported Event|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
501196|NCT00755040|B3|Baseline|Total|Total of all reporting groups
501197|NCT00755040|B2|Baseline|Placebo|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
501198|NCT00755040|B1|Baseline|Ocular Cyclosporine (Restasis)|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
501199|NCT00755040|P2|Participant Flow|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
501200|NCT00755040|P1|Participant Flow|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
501201|NCT00755040|O2|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
501202|NCT00755040|O1|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
501203|NCT00755040|O2|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
501204|NCT00755040|O1|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
501205|NCT00755040|E2|Reported Event|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
501206|NCT00755040|E1|Reported Event|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
501207|NCT00754923|B1|Baseline|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
501208|NCT00754923|P1|Participant Flow|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
501209|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
501210|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
501211|NCT00754923|E1|Reported Event|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
501212|NCT00754832|B1|Baseline|Intent to Treat Study Population|all participants who received at least one dose of either placebo or ginseng in this crossover trial
501213|NCT00754832|P2|Participant Flow|Placebo First Then Ginseng|placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
501214|NCT00754832|P1|Participant Flow|Ginseng First Then Placebo|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks
501215|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
501216|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
501217|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
501218|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
501219|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
501220|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
501221|NCT00754832|E2|Reported Event|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
501222|NCT00754832|E1|Reported Event|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
501223|NCT00754793|B3|Baseline|Total|Total of all reporting groups
501224|NCT00754793|B2|Baseline|Placebo|Placebo drug
501225|NCT00754793|B1|Baseline|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
501226|NCT00754793|P2|Participant Flow|Placebo|Placebo drug
501227|NCT00754793|P1|Participant Flow|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
501228|NCT00754793|O2|Outcome|Placebo|Placebo drug
501235|NCT00754767|P2|Participant Flow|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
501236|NCT00754767|P1|Participant Flow|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
501237|NCT00754767|O2|Outcome|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
501238|NCT00754767|O1|Outcome|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
501239|NCT00754767|E2|Reported Event|Arm II-Placebo|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
501240|NCT00754767|E1|Reported Event|Arm I L-Carnitine|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
501241|NCT00754741|B4|Baseline|Total|Total of all reporting groups
501242|NCT00754741|B3|Baseline|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501243|NCT00754741|B2|Baseline|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501244|NCT00754741|B1|Baseline|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501245|NCT00754741|P3|Participant Flow|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501246|NCT00754741|P2|Participant Flow|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501247|NCT00754741|P1|Participant Flow|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501248|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501249|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501250|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501251|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501252|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501253|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501254|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501255|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501256|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501277|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501257|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501258|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501259|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501260|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501261|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501262|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501263|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501264|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501265|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501266|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501267|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501268|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501269|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501270|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501271|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501272|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501273|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501274|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501275|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501276|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501278|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501279|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501280|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501281|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501282|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501283|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501284|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501285|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501286|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501287|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501288|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501289|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501290|NCT00754741|E3|Reported Event|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
501291|NCT00754741|E2|Reported Event|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
501292|NCT00754741|E1|Reported Event|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
501293|NCT00754650|B1|Baseline|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
501294|NCT00754650|P1|Participant Flow|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
501295|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
501296|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
501297|NCT00754650|E1|Reported Event|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
501298|NCT00754624|B1|Baseline|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501299|NCT00754624|P1|Participant Flow|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501300|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501301|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501302|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501303|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501304|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501305|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501306|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
501308|NCT00754572|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501309|NCT00754572|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (iv), once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throuhgout the study.
501310|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501311|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501312|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501313|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501314|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501315|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501316|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501317|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501318|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501319|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501320|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501321|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501322|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501323|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501324|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501325|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501326|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501327|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501328|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501329|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501330|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501331|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501332|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501333|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501552|NCT00754130|B7|Baseline|Total|Total of all reporting groups
501334|NCT00754572|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
501335|NCT00754559|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501336|NCT00754559|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks for a total of 6 infusions.
501337|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg /kg iv every 4 weeks for a total of 6 infusions.
501338|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501339|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501340|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501341|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501342|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501343|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501344|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501345|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501346|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501347|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501348|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501349|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501350|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501351|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501352|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
501353|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501354|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501355|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501356|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501357|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501358|NCT00754559|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
501359|NCT00754546|B1|Baseline|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
501360|NCT00754546|P1|Participant Flow|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
501361|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
501362|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
501363|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
501364|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
501365|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
501366|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
501367|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
501368|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
501369|NCT00754546|E4|Reported Event|Cycle Exercise With the Placebo Comparator|
501370|NCT00754546|E3|Reported Event|Treadmill Exercise With the Placebo Comparator|
501371|NCT00754546|E2|Reported Event|Cycle Exercise With the Active Comparator|
501372|NCT00754546|E1|Reported Event|Treadmill Exercise With the Active Comparator|
501373|NCT00754494|B4|Baseline|Total|Total of all reporting groups
501374|NCT00754494|B3|Baseline|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501375|NCT00754494|B2|Baseline|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501376|NCT00754494|B1|Baseline|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501377|NCT00754494|P3|Participant Flow|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501378|NCT00754494|P2|Participant Flow|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501379|NCT00754494|P1|Participant Flow|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501553|NCT00754130|B6|Baseline|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
501380|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501381|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501382|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501383|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501384|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501385|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501386|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501387|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501388|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501389|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501390|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501391|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501392|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501393|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501394|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501395|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501396|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501397|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501398|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501399|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501400|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501401|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501402|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501403|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501404|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501405|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501406|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501407|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501408|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501409|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501410|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501411|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501412|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501413|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501414|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501415|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501416|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
501417|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
501418|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
501419|NCT00754494|E3|Reported Event|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501420|NCT00754494|E2|Reported Event|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501421|NCT00754494|E1|Reported Event|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
501422|NCT00754468|B3|Baseline|Total|Total of all reporting groups
501423|NCT00754468|B2|Baseline|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
501424|NCT00754468|B1|Baseline|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
501485|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501486|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501487|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501425|NCT00754468|P2|Participant Flow|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
501426|NCT00754468|P1|Participant Flow|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
501427|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds
501428|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment
501429|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 2 cycles x20 seconds~Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds"
501430|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds~Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment"
501431|NCT00754468|E2|Reported Event|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
501432|NCT00754468|E1|Reported Event|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
501433|NCT00754442|B3|Baseline|Total|Total of all reporting groups
501434|NCT00754442|B2|Baseline|Patient Group|patients with secondary hyperparathyroidism
501435|NCT00754442|B1|Baseline|Controls|controls with normal PTH
501436|NCT00754442|P2|Participant Flow|Patient Group|patients with secondary hyperparathyroidism
501437|NCT00754442|P1|Participant Flow|Controls|controls with normal PTH
501438|NCT00754442|O1|Outcome|Patients|patients with idiopathic secondary hyperparathyroidism
501439|NCT00754442|O2|Outcome|Controls|Controls without secondary hyperparathyroidism
501440|NCT00754442|O1|Outcome|Group 1|"patients with secondary hyperparathyroidism"
501441|NCT00754442|E2|Reported Event|Patient Group|patients with secondary hyperparathyroidism
501442|NCT00754442|E1|Reported Event|Controls|controls with normal PTH
501443|NCT00754390|B1|Baseline|Entire Study Population|Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment
501444|NCT00754390|P1|Participant Flow|Calcium and Phytate Interactions|Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order
501445|NCT00754390|O4|Outcome|High Calcium, High Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day
501446|NCT00754390|O3|Outcome|High Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day
501447|NCT00754390|O2|Outcome|Moderate Calcium, High Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day
501448|NCT00754390|O1|Outcome|Moderate Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day
501449|NCT00754390|E1|Reported Event|Overall Study|Participants consumed 4 dietary treatments in randomized order
501450|NCT00754377|B3|Baseline|Total|Total of all reporting groups
501451|NCT00754377|B2|Baseline|Comparison Group|Didn't receive intervention
501452|NCT00754377|B1|Baseline|PBLI Curriculum Group|Received PBLI curriculum to evaluate and develop tools.
501453|NCT00754377|P2|Participant Flow|Comparison Group|Alternate rotations and didn't receive intervention
501488|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501554|NCT00754130|B5|Baseline|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
501454|NCT00754377|P1|Participant Flow|PBL Curriculum Group|"To evaluate preliminary data on a PBLI curriculum grounded on QI system projects.~PBLI curriculum comparison: The design is a pre-post comparison of PBLI curriculum participants versus non-participants. Data will come from the closed-ended items on the questionnaire given before the rotation and at the end of the rotation. PBLI curriculum was offered on alternate rotations (residents on alternate month were involved with a different curriculum). Preliminary data is available from 11 blocks, 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42) during the previous academic year. Closed-ended items assessed beliefs about different aspects of Continuous Quality Improvement (CQI) project development and implementation (6 items). In addition, there were 5 short definition items to address knowledge. Finally, content analysis methods will be used to evaluate responses to the open-ended item which asked respondents to develop a project to improve patient care."
501455|NCT00754377|O2|Outcome|Comparison Group|Didn't receive the intervention.
501456|NCT00754377|O1|Outcome|PBLI Curriclum Group|Received the intervention and evaluate and develop PBLI tools
501457|NCT00754377|O2|Outcome|Comparison Group|Didn't receive intervention
501458|NCT00754377|O1|Outcome|PBLI Curriculum Group|Received the intervention and used to evaluate and develop PBLI tools
501459|NCT00754377|E2|Reported Event|Comparison Group|Didn't receive the intervention
501460|NCT00754377|E1|Reported Event|PBLI Curriculum Group|Received the intervention. To evaluate and develop PBLI tools.
501461|NCT00754338|B5|Baseline|Total|Total of all reporting groups
501462|NCT00754338|B4|Baseline|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501463|NCT00754338|B3|Baseline|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501464|NCT00754338|B2|Baseline|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501465|NCT00754338|B1|Baseline|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501466|NCT00754338|P4|Participant Flow|Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
501467|NCT00754338|P3|Participant Flow|Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
501468|NCT00754338|P2|Participant Flow|Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
501469|NCT00754338|P1|Participant Flow|Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
501470|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501471|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501472|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501473|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501474|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501475|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501476|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501477|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501478|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501479|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501480|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501481|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501482|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501483|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501484|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501850|NCT00754052|O2|Outcome|Placebo|Participants received matching placebo in a 1:1:1 ratio.
501489|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501490|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501491|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501492|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
501493|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501494|NCT00754338|E4|Reported Event|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501495|NCT00754338|E3|Reported Event|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501496|NCT00754338|E2|Reported Event|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
501497|NCT00754338|E1|Reported Event|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
501498|NCT00754325|B3|Baseline|Total|Total of all reporting groups
501499|NCT00754325|B2|Baseline|Fulvestrant|"Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501500|NCT00754325|B1|Baseline|Fulvestrant and Dasatinib|"Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501501|NCT00754325|P2|Participant Flow|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501502|NCT00754325|P1|Participant Flow|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501503|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501504|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501505|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501506|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501507|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501508|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501509|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501510|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501511|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501512|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501549|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
501513|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501514|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501515|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501516|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501517|NCT00754325|E3|Reported Event|Fulvestrant Crossover to Fulvestrant and Dasatinib|"Arm 2b: Participants in this group started on the Fulvestrant only arm and later started receiving a drug regimen that consisted of both fulvestrant and dasatinib. These participants are all inclusive and not limited to Fulvestrant or Fulvestrant and Dasatinib treatment only. The timeframe for when these events occurred were not immediately available and may have been caused by previous exposure to Fulvestrant only (pre-crossover), therefore the events for this patient population are also reported separately.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501518|NCT00754325|E2|Reported Event|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
501519|NCT00754325|E1|Reported Event|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
501520|NCT00754234|B1|Baseline|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
501521|NCT00754234|P1|Participant Flow|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
501522|NCT00754234|O1|Outcome|MyPyramid Menu|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
501523|NCT00754234|E1|Reported Event|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
501524|NCT00754208|B1|Baseline|Ritalin LA for ADHD|4 and 5 year old subjects with ADHD
501525|NCT00754208|P1|Participant Flow|Ritalin LA for ADHD|Subjects treated with Ritalin LA for ADHD
501526|NCT00754208|O1|Outcome|Group 1|All subjects treated with open-label methylphenidate
501527|NCT00754208|O1|Outcome|Group 1|All subjects treated with open-label methylphenidate
501528|NCT00754208|O1|Outcome|Group 1|All subjects treated with open-label methylphenidate
501529|NCT00754208|O1|Outcome|Group 1|All subjects treated with open-label methylphenidate (Ritalin LA)
501530|NCT00754208|E1|Reported Event|Methylpehnidate|"open-label treatment with methylphenidate~methylphenidate: Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day."
501531|NCT00754156|B3|Baseline|Total|Total of all reporting groups
501532|NCT00754156|B2|Baseline|V.A.C. or ABThera|V.A.C. or ABThera Therapy alone
501533|NCT00754156|B1|Baseline|1 ABRA Plus V.A.C or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy
501534|NCT00754156|P2|Participant Flow|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
501535|NCT00754156|P1|Participant Flow|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
501536|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
501537|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
501538|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
501539|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
501540|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
501541|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
501542|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
501543|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
501544|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|V.A.C. or ABThera V.A.C. Therapy alone
501545|NCT00754156|O1|Outcome|1 ABRA Plus V.A.C. or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or ABThera V.A.C. Therapy
501546|NCT00754156|O2|Outcome|2 ABThera|V.A.C. or ABThera V.A.C. Therapy alone
501547|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C or ABThera V.A.C. Therapy
501548|NCT00754156|O2|Outcome|2 ABThera|ABThera V.A.C. Therapy alone
501550|NCT00754156|E2|Reported Event|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
501557|NCT00754130|B2|Baseline|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
501558|NCT00754130|B1|Baseline|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
501559|NCT00754130|P6|Participant Flow|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
501560|NCT00754130|P5|Participant Flow|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
501561|NCT00754130|P4|Participant Flow|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
501562|NCT00754130|P3|Participant Flow|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
501563|NCT00754130|P2|Participant Flow|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
501564|NCT00754130|P1|Participant Flow|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
501565|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
501566|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501567|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501568|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501569|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
501570|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501571|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501572|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501573|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
501574|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
501575|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501576|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501577|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501578|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
501579|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501580|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501581|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501582|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
501583|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501584|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501585|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501586|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
501587|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501588|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501589|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501590|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
501591|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501592|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501593|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501594|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
501595|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501596|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501597|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501598|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
501599|NCT00754130|E5|Reported Event|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
501600|NCT00754130|E4|Reported Event|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
501601|NCT00754130|E3|Reported Event|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
501602|NCT00754130|E2|Reported Event|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
501603|NCT00754130|E1|Reported Event|Placebo|Participants receiving Placebo doses three times daily
501604|NCT00754065|B3|Baseline|Total|Total of all reporting groups
501605|NCT00754065|B2|Baseline|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501606|NCT00754065|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501607|NCT00754065|P2|Participant Flow|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501608|NCT00754065|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501609|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501610|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501611|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501612|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501613|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501614|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501615|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501616|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501617|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501618|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501619|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501620|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501621|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501622|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501623|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501624|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501625|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501626|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501627|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501628|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501629|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501630|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501631|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502117|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
501632|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501633|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501634|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501635|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501636|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501637|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501638|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501639|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501640|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501641|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501642|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501643|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501644|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501645|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501646|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501647|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501648|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501649|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501650|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501651|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501652|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501653|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501654|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501655|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502118|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
501656|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501657|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501658|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501659|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501660|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501661|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501662|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501663|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501664|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501665|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501666|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501667|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501668|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501669|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501670|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501671|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501672|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501673|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501674|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501675|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501676|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501677|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501678|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501679|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502119|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
501680|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501681|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501682|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501683|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501684|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501685|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501686|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501687|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501688|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501689|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501690|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501691|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501692|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501693|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501694|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501695|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501696|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501697|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501698|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501699|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501700|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501701|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501702|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501703|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502120|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
501704|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501705|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501706|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501707|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501708|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501709|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501710|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501711|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501712|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501713|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501714|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501715|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501716|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501717|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501718|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501719|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501720|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501721|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501722|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501723|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501724|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501725|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501726|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501727|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502121|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
501728|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501729|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501730|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501731|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501732|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501733|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501734|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501735|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501736|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501737|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501738|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501739|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501740|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501741|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501742|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501743|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501744|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501745|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501746|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501747|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501748|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501749|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501750|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501751|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502122|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
501752|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501753|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501754|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501755|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501756|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501757|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501758|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501759|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501760|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501761|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501762|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501763|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501764|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501765|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501766|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501767|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501768|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501769|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501770|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501771|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501772|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501773|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501774|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501775|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502123|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
501776|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501777|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501778|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501779|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501780|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501781|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501782|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501783|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501784|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501785|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501786|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501787|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501788|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501789|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501790|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501791|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501792|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501793|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501794|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501795|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501796|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501797|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501798|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501799|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502124|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
501800|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501801|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501802|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501803|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501804|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501805|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501806|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501807|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501808|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501809|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501810|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501811|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501812|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501813|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501814|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501815|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501816|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501817|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501818|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501819|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501820|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501821|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501822|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501823|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
502125|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
501824|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501825|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501826|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501827|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501828|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501829|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501830|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501831|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501832|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501833|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501834|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501835|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501836|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501837|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501838|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501839|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501840|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501841|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501842|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501843|NCT00754065|E2|Reported Event|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
501844|NCT00754065|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)
501845|NCT00754052|B3|Baseline|Total|Total of all reporting groups
501846|NCT00754052|B2|Baseline|Placebo|Participants received matching placebo in a 1:1:1 ratio.
501847|NCT00754052|B1|Baseline|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
501848|NCT00754052|P2|Participant Flow|Placebo|Participants received matching placebo in a 1:1:1 ratio.
501849|NCT00754052|P1|Participant Flow|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 milligrams per kilograms per day (mg/kg/day) or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
501851|NCT00754052|O1|Outcome|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
501852|NCT00754052|O2|Outcome|Placebo|Participants received matching placebo in a 1:1:1 ratio.
501853|NCT00754052|O1|Outcome|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
501854|NCT00754052|O2|Outcome|Placebo|Participants received matching placebo in a 1:1:1 ratio.
501855|NCT00754052|O1|Outcome|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
501856|NCT00754052|O2|Outcome|Placebo|Participants received matching placebo in a 1:1:1 ratio.
501857|NCT00754052|O1|Outcome|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
501858|NCT00754052|E2|Reported Event|Placebo|Participants received matching placebo in a 1:1:1 ratio.
501859|NCT00754052|E1|Reported Event|Donepezil Hydrochloride|Blinded oral donepezil hydrochloride, was started at 2.5 mL daily, followed by 2-week titration intervals over a period of 6 weeks until a maximum dose of 5 mg/kg/day or 10 mg/kg/day was reached. Due to early termination of the study no participant reached either targeted maximum.
501860|NCT00754013|B3|Baseline|Total|Total of all reporting groups
501861|NCT00754013|B2|Baseline|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
501862|NCT00754013|B1|Baseline|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
501863|NCT00754013|P2|Participant Flow|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
501864|NCT00754013|P1|Participant Flow|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
501865|NCT00754013|O2|Outcome|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
501866|NCT00754013|O1|Outcome|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
501867|NCT00754013|O2|Outcome|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
501868|NCT00754013|O1|Outcome|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
501869|NCT00754013|E2|Reported Event|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
501870|NCT00754013|E1|Reported Event|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
501871|NCT00753948|B4|Baseline|Total|Total of all reporting groups
501872|NCT00753948|B3|Baseline|Healthy Controls|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501873|NCT00753948|B2|Baseline|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501874|NCT00753948|B1|Baseline|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501875|NCT00753948|P3|Participant Flow|Healthy Control|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501876|NCT00753948|P2|Participant Flow|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501877|NCT00753948|P1|Participant Flow|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501878|NCT00753948|O3|Outcome|Arm 3|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501879|NCT00753948|O2|Outcome|Arm 2|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501880|NCT00753948|O1|Outcome|Arm 1|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501881|NCT00753948|E3|Reported Event|Arm 3|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501882|NCT00753948|E2|Reported Event|Arm 2|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501883|NCT00753948|E1|Reported Event|Arm 1|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
501884|NCT00753935|B3|Baseline|Total|Total of all reporting groups
501885|NCT00753935|B2|Baseline|Chewable Aspirin|Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks
501886|NCT00753935|B1|Baseline|Enteric-coated Aspirin|patients with coronary artery disease received enteric-coated aspirin 81 mg qd for 2 weeks
501887|NCT00753935|P2|Participant Flow|Chewable Aspirin|"Patients received chewable aspirin 81 mg qd for 2 weeks~Chewable aspirin: chewable aspirin 81mg daily for 2 weeks"
501888|NCT00753935|P1|Participant Flow|Enteric-coated Aspirin|"patients received enteric-coated aspirin 81 mg qd for 2 weeks~enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks"
501889|NCT00753935|O2|Outcome|Chewable Aspirin|"Patients received chewable aspirin 81 mg qd for 2 weeks~Chewable aspirin: chewable aspirin 81mg daily for 2 weeks"
502126|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
501890|NCT00753935|O1|Outcome|Enteric-coated Aspirin|"patients received enteric-coated aspirin 81 mg qd for 2 weeks~enteric-coated aspirin: enteric-coated aspirin 81mg daily for 2 weeks"
501891|NCT00753935|E2|Reported Event|Chewable Aspirin|Patients with coronary artery disease received chewable aspirin 81 mg qd for 2 weeks
501892|NCT00753935|E1|Reported Event|Enteric-coated Aspirin|patients with coronary artery disease received enteric-coated aspirin 81 mg qd for 2 weeks
501893|NCT00753922|B5|Baseline|Total|Total of all reporting groups
501894|NCT00753922|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501895|NCT00753922|B3|Baseline|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501896|NCT00753922|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
501897|NCT00753922|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501898|NCT00753922|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501899|NCT00753922|P3|Participant Flow|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501900|NCT00753922|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
501901|NCT00753922|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501902|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501903|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501904|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
501905|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501906|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501907|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501908|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
501909|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501910|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501911|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501912|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
501913|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501914|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501915|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501916|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
502127|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
501917|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501918|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501919|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501920|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
501921|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501922|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501923|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501924|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
501925|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501926|NCT00753922|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
501927|NCT00753922|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
501928|NCT00753922|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
501929|NCT00753922|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
501930|NCT00753896|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501931|NCT00753896|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501932|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501933|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501934|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501935|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501936|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501937|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501938|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501939|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501940|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501941|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501942|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501943|NCT00753896|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
501944|NCT00753766|B3|Baseline|Total|Total of all reporting groups
501945|NCT00753766|B2|Baseline|Control|Control group
501946|NCT00753766|B1|Baseline|Intervention|"Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.~Multifactorial Intervention: Intervention included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise."
501947|NCT00753766|P2|Participant Flow|Usual Care|Control group
501948|NCT00753766|P1|Participant Flow|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
501949|NCT00753766|O2|Outcome|Usual Care|Control group
501950|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
501951|NCT00753766|O2|Outcome|Usual Care|Control group
501952|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
501953|NCT00753766|E2|Reported Event|Usual Care|Control group
501954|NCT00753766|E1|Reported Event|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
501955|NCT00753714|B3|Baseline|Total|Total of all reporting groups
501969|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501956|NCT00753714|B2|Baseline|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501957|NCT00753714|B1|Baseline|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501958|NCT00753714|P2|Participant Flow|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501959|NCT00753714|P1|Participant Flow|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501960|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501961|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501962|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501963|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501964|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501965|NCT00753714|O1|Outcome|ZD6474 ( (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501966|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501967|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501968|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501970|NCT00753714|E2|Reported Event|Placebo to Match ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
501971|NCT00753714|E1|Reported Event|ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
501972|NCT00753688|B3|Baseline|Total|Total of all reporting groups
501973|NCT00753688|B2|Baseline|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501974|NCT00753688|B1|Baseline|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501975|NCT00753688|P2|Participant Flow|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501976|NCT00753688|P1|Participant Flow|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501977|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501978|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501979|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501980|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501981|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501982|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501983|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501984|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501985|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501986|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501987|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501988|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501989|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501990|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501991|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501992|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501993|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501994|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501995|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501996|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501997|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501998|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
501999|NCT00753688|E2|Reported Event|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
502000|NCT00753688|E1|Reported Event|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
502001|NCT00753675|B4|Baseline|Total|Total of all reporting groups
502002|NCT00753675|B3|Baseline|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502003|NCT00753675|B2|Baseline|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502004|NCT00753675|B1|Baseline|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502005|NCT00753675|P3|Participant Flow|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502006|NCT00753675|P2|Participant Flow|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502007|NCT00753675|P1|Participant Flow|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502008|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502009|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502010|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502011|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502012|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502013|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502014|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502015|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502016|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502017|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502058|NCT00753636|E1|Reported Event|Isradipine 20mg, 15mg, 10mg or 5 mg|
502018|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502019|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502020|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502021|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502022|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502023|NCT00753675|E3|Reported Event|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
502024|NCT00753675|E2|Reported Event|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
502025|NCT00753675|E1|Reported Event|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
502026|NCT00753649|B3|Baseline|Total|Total of all reporting groups
502027|NCT00753649|B2|Baseline|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502028|NCT00753649|B1|Baseline|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502029|NCT00753649|P2|Participant Flow|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502030|NCT00753649|P1|Participant Flow|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502031|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502032|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502033|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502034|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502035|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502059|NCT00753623|B3|Baseline|Total|Total of all reporting groups
502036|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502037|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502038|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502039|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502040|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502041|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502042|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502043|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502044|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502045|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502046|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502047|NCT00753649|E2|Reported Event|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502048|NCT00753649|E1|Reported Event|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
502049|NCT00753636|B1|Baseline|Isradipine 20mg, 15mg, 10mg or 5 mg|
502050|NCT00753636|P1|Participant Flow|Isradipine 20mg, 15mg, 10mg or 5 mg|
502051|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
502052|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
502053|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
502054|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
502055|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
502056|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
502057|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
502060|NCT00753623|B2|Baseline|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.~Ramelteon : ramelteon (8 mg)"
502061|NCT00753623|B1|Baseline|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.~Ramelteon : ramelteon (8 mg)"
502062|NCT00753623|P2|Participant Flow|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.~Ramelteon : ramelteon (8 mg)"
502063|NCT00753623|P1|Participant Flow|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.~Ramelteon : ramelteon (8 mg)"
502064|NCT00753623|O2|Outcome|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
502065|NCT00753623|O1|Outcome|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
502066|NCT00753623|E2|Reported Event|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
502067|NCT00753623|E1|Reported Event|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
502068|NCT00753545|B3|Baseline|Total|Total of all reporting groups
502069|NCT00753545|B2|Baseline|Placebo bd|olaparib matching placebo oral capsules twice daily
502070|NCT00753545|B1|Baseline|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502071|NCT00753545|P2|Participant Flow|Placebo bd|olaparib matching placebo oral capsules twice daily
502072|NCT00753545|P1|Participant Flow|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502073|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502074|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502075|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502076|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502077|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502078|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502079|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502080|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502081|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502082|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502083|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502084|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502085|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502086|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502087|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502088|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502089|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502090|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502091|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502092|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502093|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502094|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502095|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502096|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502097|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502098|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502099|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502100|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502101|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502102|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502103|NCT00753545|O2|Outcome|Placebo bd|olaparib matching placebo oral capsules twice daily
502104|NCT00753545|O1|Outcome|Olaparib 400 mg bd|AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
502105|NCT00753545|E2|Reported Event|Placebo|
502106|NCT00753545|E1|Reported Event|Olaparib 400 mg bd|
502107|NCT00753519|B3|Baseline|Total|Total of all reporting groups
502108|NCT00753519|B2|Baseline|Sham iTBS|Sham iTBS
502109|NCT00753519|B1|Baseline|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
502110|NCT00753519|P2|Participant Flow|Sham iTBS|Sham iTBS
502111|NCT00753519|P1|Participant Flow|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
502112|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
502113|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
502114|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
502115|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
502116|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
502128|NCT00753519|E2|Reported Event|Sham iTBS|Sham iTBS
502129|NCT00753519|E1|Reported Event|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
502130|NCT00753506|B3|Baseline|Total|Total of all reporting groups
502131|NCT00753506|B2|Baseline|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
502132|NCT00753506|B1|Baseline|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
502133|NCT00753506|P2|Participant Flow|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
502134|NCT00753506|P1|Participant Flow|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
502135|NCT00753506|O2|Outcome|Placebo|100 mg artemisinin identical placebo capsule taken twice per day.
502136|NCT00753506|O1|Outcome|Artemisinin|100 mg capsule of artemisinin taken twice per day.
502137|NCT00753506|E2|Reported Event|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
502138|NCT00753506|E1|Reported Event|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
502139|NCT00753454|B1|Baseline|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502140|NCT00753454|P1|Participant Flow|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502141|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502142|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502143|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502144|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502145|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502183|NCT00753415|P1|Participant Flow|Part A: V935 LD|Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
502146|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502147|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502148|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502149|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502150|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502151|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502152|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502153|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502154|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502155|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502156|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502157|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502158|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502159|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502182|NCT00753415|P2|Participant Flow|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
502160|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502161|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502162|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502163|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502164|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502165|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502166|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502167|NCT00753454|E1|Reported Event|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
502168|NCT00753415|B6|Baseline|Total|Total of all reporting groups
502169|NCT00753415|B5|Baseline|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502170|NCT00753415|B4|Baseline|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502171|NCT00753415|B3|Baseline|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
502172|NCT00753415|B2|Baseline|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
502173|NCT00753415|B1|Baseline|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
502174|NCT00753415|P10|Participant Flow|Part B: V934 HD(5)+V934 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502175|NCT00753415|P9|Participant Flow|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502176|NCT00753415|P8|Participant Flow|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502177|NCT00753415|P7|Participant Flow|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502178|NCT00753415|P6|Participant Flow|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
502179|NCT00753415|P5|Participant Flow|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502180|NCT00753415|P4|Participant Flow|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502181|NCT00753415|P3|Participant Flow|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
502184|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502185|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502186|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
502187|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502188|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502189|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502190|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502191|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
502192|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
502193|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
502194|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502195|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502196|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502197|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502198|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502199|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502200|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502201|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
502202|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
502203|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
502204|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502205|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502206|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502207|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502208|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502209|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502210|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502211|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
502212|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
502213|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
502265|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502266|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502214|NCT00753415|E10|Reported Event|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502215|NCT00753415|E9|Reported Event|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502216|NCT00753415|E8|Reported Event|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502217|NCT00753415|E7|Reported Event|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502218|NCT00753415|E6|Reported Event|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
502219|NCT00753415|E5|Reported Event|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502220|NCT00753415|E4|Reported Event|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
502221|NCT00753415|E3|Reported Event|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
502222|NCT00753415|E2|Reported Event|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
502223|NCT00753415|E1|Reported Event|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
502224|NCT00753363|B3|Baseline|Total|Total of all reporting groups
502225|NCT00753363|B2|Baseline|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
502226|NCT00753363|B1|Baseline|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
502227|NCT00753363|P2|Participant Flow|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
502228|NCT00753363|P1|Participant Flow|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
502229|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
502230|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
502231|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
502232|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
502233|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
502234|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
502235|NCT00753363|E2|Reported Event|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
502236|NCT00753363|E1|Reported Event|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
502237|NCT00753337|B1|Baseline|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502238|NCT00753337|P1|Participant Flow|Assurant Cobalt Iliac Stent|Cobalt stent implanted using standard percutaneous intervention technique.
502239|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting.
502240|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502241|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502242|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502243|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502244|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502245|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502246|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502247|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502248|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502249|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
502250|NCT00753337|E1|Reported Event|Assurant Cobalt Iliac Stent|Treatment with Iliac stenting system
502251|NCT00753298|B3|Baseline|Total|Total of all reporting groups
502252|NCT00753298|B2|Baseline|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502253|NCT00753298|B1|Baseline|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502254|NCT00753298|P2|Participant Flow|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502255|NCT00753298|P1|Participant Flow|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502256|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502257|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502258|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502259|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502260|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502261|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502262|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502263|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502264|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502267|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502268|NCT00753298|E2|Reported Event|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
502269|NCT00753298|E1|Reported Event|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
502270|NCT00753272|B3|Baseline|Total|Total of all reporting groups
502271|NCT00753272|B2|Baseline|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502272|NCT00753272|B1|Baseline|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502273|NCT00753272|P2|Participant Flow|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502274|NCT00753272|P1|Participant Flow|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502275|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
502276|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
502277|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
502278|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502279|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502280|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502281|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502282|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502283|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502284|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502285|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502286|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502287|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502288|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502289|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502290|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502291|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502292|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502293|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502294|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502295|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502296|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
504120|NCT00746889|E2|Reported Event|Placebo|Intraarticular injection of 0.9% saline
502297|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502298|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502299|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502300|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502301|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502302|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502303|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502304|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502305|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502306|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502307|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502308|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502309|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502310|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502311|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502312|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502313|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502314|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502315|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502316|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502317|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502318|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502319|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502320|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502321|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502322|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502323|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502324|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
504214|NCT00746733|O2|Outcome|Adderall XR|
502325|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502326|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502327|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502328|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502329|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502330|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
502331|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
502332|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
502333|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502334|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502335|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502336|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502337|NCT00753272|E2|Reported Event|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502338|NCT00753272|E1|Reported Event|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
502339|NCT00753220|B1|Baseline|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
502340|NCT00753220|P1|Participant Flow|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
502341|NCT00753220|O1|Outcome|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
502342|NCT00753220|E1|Reported Event|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
502343|NCT00753142|B4|Baseline|Total|Total of all reporting groups
502344|NCT00753142|B3|Baseline|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
502345|NCT00753142|B2|Baseline|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
502346|NCT00753142|B1|Baseline|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
502347|NCT00753142|P3|Participant Flow|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
502348|NCT00753142|P2|Participant Flow|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
502349|NCT00753142|P1|Participant Flow|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
502350|NCT00753142|O3|Outcome|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
502351|NCT00753142|O2|Outcome|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
502352|NCT00753142|O1|Outcome|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
502353|NCT00753142|E3|Reported Event|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
502354|NCT00753142|E2|Reported Event|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
502355|NCT00753142|E1|Reported Event|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
502356|NCT00753012|B3|Baseline|Total|Total of all reporting groups
502357|NCT00753012|B2|Baseline|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
504215|NCT00746733|O1|Outcome|Vyvanse|
502358|NCT00753012|B1|Baseline|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
502359|NCT00753012|P2|Participant Flow|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
502360|NCT00753012|P1|Participant Flow|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
502361|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
502362|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
502363|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
502364|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
502365|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
502366|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
502367|NCT00753012|E2|Reported Event|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
502368|NCT00753012|E1|Reported Event|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
502369|NCT00752986|B4|Baseline|Total|Total of all reporting groups
502370|NCT00752986|B3|Baseline|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
502371|NCT00752986|B2|Baseline|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502372|NCT00752986|B1|Baseline|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502373|NCT00752986|P3|Participant Flow|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
502374|NCT00752986|P2|Participant Flow|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502375|NCT00752986|P1|Participant Flow|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502376|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
502377|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502378|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502379|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
502380|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502381|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502382|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
502383|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502384|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502385|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
502386|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502387|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
504216|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
502388|NCT00752986|E3|Reported Event|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
502389|NCT00752986|E2|Reported Event|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502390|NCT00752986|E1|Reported Event|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
502391|NCT00752973|B1|Baseline|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
502392|NCT00752973|P1|Participant Flow|Malathion Gel 0.5% Treatment Arm|"Malathion Gel 0.5% treatment~MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes"
502393|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
502394|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
502395|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
502396|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
502397|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
502398|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~A subject had out of range (low) RBC cholinesterase value 1 h post treatment. This value was considered to be not clinically significant by the investigator."
502399|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
502400|NCT00752973|E1|Reported Event|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
502401|NCT00752895|B3|Baseline|Total|Total of all reporting groups
502402|NCT00752895|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
502403|NCT00752895|B1|Baseline|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
502404|NCT00752895|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
502405|NCT00752895|P1|Participant Flow|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
502406|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
502407|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
502408|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
502409|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
502410|NCT00752895|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
502411|NCT00752895|E1|Reported Event|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
502412|NCT00752791|B1|Baseline|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502413|NCT00752791|P1|Participant Flow|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502414|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502415|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502416|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502417|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502506|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502676|NCT00751790|P1|Participant Flow|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
502418|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502419|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502420|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502421|NCT00752791|E1|Reported Event|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502422|NCT00752726|B3|Baseline|Total|Total of all reporting groups
502423|NCT00752726|B2|Baseline|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures.
502424|NCT00752726|B1|Baseline|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures.
502425|NCT00752726|P2|Participant Flow|Placebo|Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day
502426|NCT00752726|P1|Participant Flow|Orlistat 60 Milligram (mg)|Orlistat 60 mg capsules taken orally with meals 3 times per day
502427|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502428|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502429|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502430|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502431|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502432|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502433|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502434|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502435|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502436|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502437|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502438|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502439|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502440|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502441|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502442|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502443|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502444|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502445|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502446|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502447|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502448|NCT00752726|E2|Reported Event|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
502449|NCT00752726|E1|Reported Event|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
502450|NCT00752622|B1|Baseline|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502451|NCT00752622|P1|Participant Flow|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502452|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502453|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502454|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502455|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502456|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502677|NCT00751790|O1|Outcome|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
502457|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502458|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
502459|NCT00752622|E2|Reported Event|Infliximab 5 mg/kg Then Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants were then randomized to receive 5 mg/kg every 6 weeks (shortened interval group) or 7 mg/kg every 8 weeks (increased dose group) at entry into the interventional phase. This reporting group included 3 participants randomized into the shortened interval group and 5 participants randomized into the increased dose group.
502460|NCT00752622|E1|Reported Event|Infliximab 5 mg/kg Then Not Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants who were further randomized into the interventional phase are not included in this reporting group; therefore, of the 100 enrolled participants, 92 participants were included in this safety reporting group.
502461|NCT00752609|B3|Baseline|Total|Total of all reporting groups
502462|NCT00752609|B2|Baseline|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502463|NCT00752609|B1|Baseline|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502464|NCT00752609|P2|Participant Flow|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502465|NCT00752609|P1|Participant Flow|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502466|NCT00752609|O3|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502467|NCT00752609|O2|Outcome|SC Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous (SC) injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502468|NCT00752609|O1|Outcome|IV Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide intravenous (IV) injection once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502469|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502470|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502471|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502472|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502473|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502474|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502475|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
504217|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
504218|NCT00746733|O2|Outcome|Adderall XR|
502476|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502477|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502478|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502479|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502480|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502481|NCT00752609|E2|Reported Event|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502482|NCT00752609|E1|Reported Event|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
502483|NCT00752232|B8|Baseline|Total|Total of all reporting groups
502484|NCT00752232|B7|Baseline|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502485|NCT00752232|B6|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502486|NCT00752232|B5|Baseline|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502487|NCT00752232|B4|Baseline|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502488|NCT00752232|B3|Baseline|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
502489|NCT00752232|B2|Baseline|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502490|NCT00752232|B1|Baseline|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502491|NCT00752232|P7|Participant Flow|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502492|NCT00752232|P6|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502493|NCT00752232|P5|Participant Flow|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502494|NCT00752232|P4|Participant Flow|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502495|NCT00752232|P3|Participant Flow|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
502496|NCT00752232|P2|Participant Flow|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502497|NCT00752232|P1|Participant Flow|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502498|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502499|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502500|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502501|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502502|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502503|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502504|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502505|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502507|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502508|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502509|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502510|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502511|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502512|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502513|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502514|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502515|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502516|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502517|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502518|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502519|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502520|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502521|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502522|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502523|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502524|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502525|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502526|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502527|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502528|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502529|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502530|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502531|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502532|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502533|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502534|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502535|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502536|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502537|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502538|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502539|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502540|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502541|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502542|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502543|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502544|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502545|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502546|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502547|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502548|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502549|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502550|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502551|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
502552|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502553|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502554|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502555|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502556|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502557|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
502558|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
502559|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502560|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502561|NCT00752232|E7|Reported Event|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
502562|NCT00752232|E6|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502563|NCT00752232|E5|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
502564|NCT00752232|E4|Reported Event|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 3, 6, 9 and 12
502565|NCT00752232|E3|Reported Event|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
502566|NCT00752232|E2|Reported Event|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
502567|NCT00752232|E1|Reported Event|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
502568|NCT00752128|B1|Baseline|Resolute Drug-Eluting Stent|
502569|NCT00752128|P1|Participant Flow|Resolute Drug-Eluting Stent|
502570|NCT00752128|O1|Outcome|Overall Stent Thrombosis (Definite and Probable-ARC)|Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition
502571|NCT00752128|O1|Outcome|Cardiac Death or Target Vessel MI|Percentage of participants that had either Cardiac Death or Myocardial Infarction (not clearly attributable to a non-target vessel)
502572|NCT00752128|E1|Reported Event|Resolute Drug-Eluting Stent|
502573|NCT00752102|B3|Baseline|Total|Total of all reporting groups
502574|NCT00752102|B2|Baseline|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
502575|NCT00752102|B1|Baseline|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
502576|NCT00752102|P2|Participant Flow|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
502577|NCT00752102|P1|Participant Flow|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
502578|NCT00752102|O2|Outcome|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
502617|NCT00751933|P3|Participant Flow|Placebo 4|"Placebo instead of vaccines No dietary supplement~Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine"
504219|NCT00746733|O1|Outcome|Vyvanse|
502579|NCT00752102|O1|Outcome|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
502580|NCT00752102|E2|Reported Event|Paricalcitol|Paricalcitol: Subjects taking paricalcitol will be started at 2 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then paricalcitol will be increased to 4 mcg 3x/week.
502581|NCT00752102|E1|Reported Event|Calcitriol|Calcitriol (Rocaltrol®): Subjects taking calcitriol will be started at 0.25 mcg 3x/week and titrated up during the next visit according to PTH levels. If at the 12 week visit, PTH is still not at goal, then calcitriol will be increased to 0.5 mcg 3x/week.
502582|NCT00752089|B1|Baseline|Overall Study Participants|All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment.
502583|NCT00752089|P1|Participant Flow|Overall Study|This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
502584|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
502585|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
502586|NCT00752089|O2|Outcome|NaF/ KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
502587|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
502588|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
502589|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
502590|NCT00752089|O2|Outcome|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
502591|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
502592|NCT00752089|E4|Reported Event|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
502593|NCT00752089|E3|Reported Event|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
502594|NCT00752089|E2|Reported Event|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
502595|NCT00752089|E1|Reported Event|NaF/ KNO3/ 2 % Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
502596|NCT00751998|B1|Baseline|Arm 1|Test of SpyGlass device
502597|NCT00751998|P1|Participant Flow|Arm 1|Test of SpyGlass device
502598|NCT00751998|O1|Outcome|Arm 1|Test of SpyGlass device
502599|NCT00751998|E1|Reported Event|Arm 1|Test of SpyGlass device
502600|NCT00751972|B3|Baseline|Total|Total of all reporting groups
502601|NCT00751972|B2|Baseline|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS (NCT00119834) during the same enrollment period.
502602|NCT00751972|B1|Baseline|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502603|NCT00751972|P2|Participant Flow|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
502604|NCT00751972|P1|Participant Flow|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502605|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502606|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502607|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502608|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502609|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502610|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
502611|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502612|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
502613|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502614|NCT00751972|E1|Reported Event|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
502615|NCT00751933|B1|Baseline|All Arms|Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.
502616|NCT00751933|P4|Participant Flow|Vaccine and Oats 1|"Vaccination with Vivotif and Dukoral + dietary supplement with oats.~Vaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7.~Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.~One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
502618|NCT00751933|P2|Participant Flow|Oats Supplement 3|"Dietary supplement with oats~Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
502619|NCT00751933|P1|Participant Flow|Vaccine Arm 2|"Vaccination with Vivotif and Dukoral~Vaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14."
502620|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
502621|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
502622|NCT00751933|E1|Reported Event|All Arms|No adverse effects were recorded.
502623|NCT00751881|B4|Baseline|Total|Total of all reporting groups
502624|NCT00751881|B3|Baseline|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502625|NCT00751881|B2|Baseline|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502626|NCT00751881|B1|Baseline|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502627|NCT00751881|P3|Participant Flow|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502628|NCT00751881|P2|Participant Flow|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502629|NCT00751881|P1|Participant Flow|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502630|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502631|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502632|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502633|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502634|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502635|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502636|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502637|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502638|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502639|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502640|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502641|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502642|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502643|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502644|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502645|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502646|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502647|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502648|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502649|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502650|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502651|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502652|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502653|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502654|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502655|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502656|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502657|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502658|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502659|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502660|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502661|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502662|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502663|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502664|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502665|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502666|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502667|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502668|NCT00751881|O1|Outcome|Placebo|Placebo once daily
502669|NCT00751881|E6|Reported Event|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502670|NCT00751881|E5|Reported Event|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
502671|NCT00751881|E4|Reported Event|Placebo / 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily
502672|NCT00751881|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
502673|NCT00751881|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
502674|NCT00751881|E1|Reported Event|Placebo|Placebo once daily
502675|NCT00751790|B1|Baseline|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
502678|NCT00751790|E1|Reported Event|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
502679|NCT00751777|B3|Baseline|Total|Total of all reporting groups
502680|NCT00751777|B2|Baseline|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
502681|NCT00751777|B1|Baseline|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
502682|NCT00751777|P2|Participant Flow|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
502683|NCT00751777|P1|Participant Flow|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
502684|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
502685|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
502686|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
502687|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
502688|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
502689|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
502690|NCT00751777|E2|Reported Event|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
502691|NCT00751777|E1|Reported Event|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
502692|NCT00751634|B1|Baseline|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
502693|NCT00751634|P1|Participant Flow|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
502694|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
502695|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
502696|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
502697|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
502698|NCT00751634|O1|Outcome|Treatment Group at 0, 1, 2, 6 Hours|Application of the Gaymar Rapr-Round device per approved use
502699|NCT00751634|E1|Reported Event|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
502700|NCT00751621|B1|Baseline|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502701|NCT00751621|P1|Participant Flow|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502702|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502703|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502704|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502705|NCT00751621|O2|Outcome|IgPro20 - At End of Study|SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
502706|NCT00751621|O1|Outcome|IgPro20 - At Baseline|SF-36 score at baseline.
502707|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502708|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502709|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502710|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502711|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502712|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502713|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502714|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502715|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502920|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
502716|NCT00751621|E1|Reported Event|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
502717|NCT00751530|B3|Baseline|Total|Total of all reporting groups
502718|NCT00751530|B2|Baseline|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502719|NCT00751530|B1|Baseline|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502720|NCT00751530|P2|Participant Flow|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502721|NCT00751530|P1|Participant Flow|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502722|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502723|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502724|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502725|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502726|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502727|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502728|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502729|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502730|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502731|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502732|NCT00751530|E2|Reported Event|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
502733|NCT00751530|E1|Reported Event|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
502734|NCT00751400|B1|Baseline|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502735|NCT00751400|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502736|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502737|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502738|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502739|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502740|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502741|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502742|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502743|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502744|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502745|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502746|NCT00751400|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
502747|NCT00751348|B3|Baseline|Total|Total of all reporting groups
502748|NCT00751348|B2|Baseline|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502749|NCT00751348|B1|Baseline|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502750|NCT00751348|P2|Participant Flow|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502751|NCT00751348|P1|Participant Flow|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502919|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
502752|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502753|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502754|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502755|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502756|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502757|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502758|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502759|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502760|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502761|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502762|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502763|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502764|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502765|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502766|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502767|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502768|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502769|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502770|NCT00751348|E2|Reported Event|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
502771|NCT00751348|E1|Reported Event|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
502772|NCT00751296|B1|Baseline|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles)."
502773|NCT00751296|P1|Participant Flow|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
502797|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502774|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
502775|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
502776|NCT00751296|E1|Reported Event|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
502777|NCT00751179|B3|Baseline|Total|Total of all reporting groups
502778|NCT00751179|B2|Baseline|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502779|NCT00751179|B1|Baseline|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502780|NCT00751179|P2|Participant Flow|Succinylcholine|An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502781|NCT00751179|P1|Participant Flow|Rocuronium - Sugammadex|An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade.
502782|NCT00751179|O1|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502783|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502784|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502785|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502786|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502787|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502788|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502789|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502790|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502791|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502792|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502793|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502794|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502795|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502796|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502798|NCT00751179|E2|Reported Event|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
502799|NCT00751179|E1|Reported Event|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
502800|NCT00751140|B1|Baseline|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
502801|NCT00751140|P1|Participant Flow|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
502802|NCT00751140|O4|Outcome|Robot-assisted RNU Lymph Node Count|Lymph Node Count for Robot-assisted RNU Procedure Group
502803|NCT00751140|O3|Outcome|Laparoscopic RNU Lymph Node Count|Lymph Node Count for Laparoscopic RNU Procedure Group
502804|NCT00751140|O2|Outcome|Open RNU Lymph Node Count|Lymph Node Count for Open RNU Procedure Group
502805|NCT00751140|O1|Outcome|Total Lymph Node Count|Total Lymph Node Count for All Participants
502806|NCT00751140|O1|Outcome|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
502807|NCT00751140|E1|Reported Event|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
502808|NCT00751114|B3|Baseline|Total|Total of all reporting groups
502809|NCT00751114|B2|Baseline|Sitagliptin|Dose of 100 mg once a day administered with or without food
502810|NCT00751114|B1|Baseline|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502811|NCT00751114|P2|Participant Flow|Sitagliptin|Dose of 100 mg once a day administered with or without food
502812|NCT00751114|P1|Participant Flow|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502813|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502814|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502815|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502816|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502817|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502818|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502819|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502820|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502821|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502822|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502823|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502824|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502825|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502826|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502827|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502828|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
504220|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
502829|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502830|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
502831|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502832|NCT00751114|E2|Reported Event|Sitagliptin|Dose of 100 mg once a day administered with or without food
502833|NCT00751114|E1|Reported Event|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
502834|NCT00751036|B3|Baseline|Total|Total of all reporting groups
502835|NCT00751036|B2|Baseline|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
502836|NCT00751036|B1|Baseline|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
502837|NCT00751036|P2|Participant Flow|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
502838|NCT00751036|P1|Participant Flow|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
502839|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
502840|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
502841|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
502842|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
502843|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
502844|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
502845|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
502846|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
502847|NCT00751036|E2|Reported Event|Imatinib 800 mg|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
502848|NCT00751036|E1|Reported Event|Nilotinib 800 mg|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
502849|NCT00750919|B1|Baseline|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502850|NCT00750919|P1|Participant Flow|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502851|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502852|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502853|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502854|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502855|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502856|NCT00750919|E1|Reported Event|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
502857|NCT00750893|B1|Baseline|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502858|NCT00750893|P1|Participant Flow|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502859|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502860|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502861|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502862|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502863|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502864|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502865|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502866|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502867|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
502868|NCT00750893|E4|Reported Event|Rotarix Year 1 to Year 6 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during the study period from Year 1 to Year 6.
502869|NCT00750893|E3|Reported Event|Rotarix Year 5 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Year 5 of the study.
502870|NCT00750893|E2|Reported Event|Rotarix Years 3 and 4 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 3 and 4 of the study.
502871|NCT00750893|E1|Reported Event|Rotarix Years 1 and 2 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 1 and 2 of the study.
502872|NCT00750880|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502873|NCT00750880|P1|Participant Flow|Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 20 weeks (total of 6 infusions).
502874|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502875|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502876|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502877|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502878|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502879|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502880|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502881|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502882|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502883|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502884|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502885|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502886|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502887|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502888|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502889|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
502890|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502891|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
502892|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502893|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
502894|NCT00750880|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
502895|NCT00750867|B1|Baseline|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
502896|NCT00750867|P1|Participant Flow|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
502897|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
502898|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
502899|NCT00750867|E1|Reported Event|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
502900|NCT00750815|B3|Baseline|Total|Total of all reporting groups
502901|NCT00750815|B2|Baseline|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
502917|NCT00750737|P2|Participant Flow|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
502918|NCT00750737|P1|Participant Flow|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
502902|NCT00750815|B1|Baseline|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
502903|NCT00750815|P2|Participant Flow|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
502904|NCT00750815|P1|Participant Flow|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
502905|NCT00750815|O2|Outcome|Standard-Risk Myeloma|"Participants eligible for risk stratification with Standard-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule Arm A."
502906|NCT00750815|O1|Outcome|High-Risk Myeloma|"Participants eligible for risk stratification with High-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as Arm A."
502907|NCT00750815|O1|Outcome|All Participants|"Arm A:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
502908|NCT00750815|O1|Outcome|All Participants|"Arm A:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
502909|NCT00750815|O1|Outcome|A. Phase I Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
502910|NCT00750815|E4|Reported Event|Maximum Tolerated Dose|Participants at Dose Level 4
502911|NCT00750815|E3|Reported Event|Dose Level 3|Participants at Dose Level 3
502912|NCT00750815|E2|Reported Event|Dose Level 2|Participants at Dose Level 2
502913|NCT00750815|E1|Reported Event|Dose Level 1|Participants at Dose Level 1
502914|NCT00750737|B3|Baseline|Total|Total of all reporting groups
502915|NCT00750737|B2|Baseline|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
502916|NCT00750737|B1|Baseline|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
502921|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
502922|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
502923|NCT00750737|E2|Reported Event|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
502924|NCT00750737|E1|Reported Event|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
502925|NCT00750373|B3|Baseline|Total|Total of all reporting groups
502926|NCT00750373|B2|Baseline|Surgery|Early surgery within 48 hours of randomization
502927|NCT00750373|B1|Baseline|Conventional|Conventional Treatment based on current guidelines
502928|NCT00750373|P2|Participant Flow|Surgery|Early surgery within 48 hours of randomization
502929|NCT00750373|P1|Participant Flow|Conventional|Conventional Treatment based on current guidelines
502930|NCT00750373|O2|Outcome|Surgery|Early surgery within 48 hours of randomization
502931|NCT00750373|O1|Outcome|Conventional|Conventional Treatment based on current guidelines
502932|NCT00750373|E2|Reported Event|Surgery|Early surgery within 48 hours of randomization
502933|NCT00750373|E1|Reported Event|Conventional|Conventional Treatment based on current guidelines
502934|NCT00750360|B7|Baseline|Total|Total of all reporting groups
502935|NCT00750360|B6|Baseline|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
502936|NCT00750360|B5|Baseline|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
502937|NCT00750360|B4|Baseline|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
502938|NCT00750360|B3|Baseline|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
502939|NCT00750360|B2|Baseline|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
502940|NCT00750360|B1|Baseline|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
502941|NCT00750360|P6|Participant Flow|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
502942|NCT00750360|P5|Participant Flow|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
502943|NCT00750360|P4|Participant Flow|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
502944|NCT00750360|P3|Participant Flow|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
502945|NCT00750360|P2|Participant Flow|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
502946|NCT00750360|P1|Participant Flow|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
502947|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
502948|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
502949|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
502950|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
502951|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
502952|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
502953|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
502954|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
502955|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
502956|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
502957|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
502958|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
502959|NCT00750360|O4|Outcome|Group A (Primed), ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
502960|NCT00750360|O3|Outcome|Group A (Primed), ≥ 108 Months to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
502961|NCT00750360|O2|Outcome|Group A (Primed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
502962|NCT00750360|O1|Outcome|Group B (Unprimed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
502963|NCT00750360|O2|Outcome|Group A (Primed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
502964|NCT00750360|O1|Outcome|Group B (Unprimed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
502965|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
502966|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
502967|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
502968|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
502969|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
502970|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
502971|NCT00750360|E6|Reported Event|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
502972|NCT00750360|E5|Reported Event|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
502973|NCT00750360|E4|Reported Event|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
502974|NCT00750360|E3|Reported Event|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
502975|NCT00750360|E2|Reported Event|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
502976|NCT00750360|E1|Reported Event|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
502977|NCT00750308|B1|Baseline|Completed Subjects|Subjects who completed all four treatment arms.
502978|NCT00750308|P12|Participant Flow|Placebo, Ramipril, Tadalafil, Combo|
502979|NCT00750308|P11|Participant Flow|Combo, Tadalafil, Ramipril, Placebo|
502980|NCT00750308|P10|Participant Flow|Ramipril, Placebo, Combo, Tadalafil|
502981|NCT00750308|P9|Participant Flow|Tadalafil, Combo, Placebo, Ramipril|
502982|NCT00750308|P8|Participant Flow|Placebo, Tadalafil, Combo, Ramipril|
502983|NCT00750308|P7|Participant Flow|Combo, Ramipril, Placebo, Tadalafil|
502984|NCT00750308|P6|Participant Flow|Ramipril, Combo, Tadalafil, Placebo|
502985|NCT00750308|P5|Participant Flow|Tadalafil, Placebo, Ramipril, Combo|
502986|NCT00750308|P4|Participant Flow|Placebo, Combo, Ramipril, Tadalafil|
502987|NCT00750308|P3|Participant Flow|Combo, Placebo, Tadalafil, Ramipril|
502988|NCT00750308|P2|Participant Flow|Ramipril, Tadalafil, Placebo, Combo|
502989|NCT00750308|P1|Participant Flow|Tadalafil, Ramipril, Combo, Placebo|
502990|NCT00750308|O4|Outcome|Combination Treatment|Measured during combination (ramipril and tadalafil) in all 18 subjects who completed treatment
502991|NCT00750308|O3|Outcome|Tadalafil Treatment|Measured during tadalafil in all 18 subjects who completed the protocol
502992|NCT00750308|O2|Outcome|Ramipril Treatment|Measured during ramipril treatment in all 18 subjects who completed the protocol
502993|NCT00750308|O1|Outcome|Placebo Treatment|Measured during placebo treatment in all 18 subjects who completed the study
502994|NCT00750308|O4|Outcome|Combination Treatment|Measurements during combination (ramipril and tadalafil) for all 18 subjects who completed the protocol
502995|NCT00750308|O3|Outcome|Tadalafil Treatment|Measurements during tadalafil treatment for all 18 subjects who completed the protocol
502996|NCT00750308|O2|Outcome|Ramipril Treatment|Measurements during ramipril treatment for all 18 subjects who completed the protocol
502997|NCT00750308|O1|Outcome|Placeb Treatment|Measurements during placebo treatment for all 18 subjects who completed the protocol
502998|NCT00750308|E4|Reported Event|Combination Treatment|Any adverse event that occurred during combination (ramipril and tadalafil) treatment in anyone who received combination treatment
502999|NCT00750308|E3|Reported Event|Tadalafil Tretament|Any adverse event that occurred during tadalafil treatment in anyone who received tadalafil treatment
503000|NCT00750308|E2|Reported Event|Ramipril Treatment|Any adverse event that occured durng ramipril treatment in anyone who received ramipril treatment
503001|NCT00750308|E1|Reported Event|Placebo Treatment|Any adverse event that occurred during placebo treatment in anyone who received placebo treatment
503002|NCT00750282|B5|Baseline|Total|Total of all reporting groups
503003|NCT00750282|B4|Baseline|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503004|NCT00750282|B3|Baseline|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503005|NCT00750282|B2|Baseline|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503006|NCT00750282|B1|Baseline|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503007|NCT00750282|P4|Participant Flow|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503008|NCT00750282|P3|Participant Flow|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503009|NCT00750282|P2|Participant Flow|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503010|NCT00750282|P1|Participant Flow|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 megabequerel (MBq) single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions.
504221|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
503011|NCT00750282|O4|Outcome|Healthy Volunteer (HV) Group (Part B)|All subjects that were confirmed by consensus panel as healthy volunteers
503012|NCT00750282|O3|Outcome|Alzheimer's (AD) Group (Part B)|"All subjects with consensus panel based diagnosis of probable AD"
503013|NCT00750282|O2|Outcome|Healthy Volunteer (HV) Group (Part A)|All evaluated healthy volunteers
503014|NCT00750282|O1|Outcome|Alzheimer's (AD) Group (Part A)|All evaluated subjects with Alzheimer's disease
503015|NCT00750282|O6|Outcome|Imaging Window 110-130 Min Part B|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
503016|NCT00750282|O5|Outcome|Imaging Window 90-110 Min Part B|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B
503017|NCT00750282|O4|Outcome|Imaging Window 45-60 Min Part B|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part B
503018|NCT00750282|O3|Outcome|Imaging Window 110-130 Min Part A|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part A.
503019|NCT00750282|O2|Outcome|Imaging Window 90-110 Min Part A|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part A
503020|NCT00750282|O1|Outcome|Imaging Window 45-60 Min Part A|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part A
503021|NCT00750282|O4|Outcome|HV (Specificity) Group (Part B)|All evaluated healthy volunteers from Part B
503022|NCT00750282|O3|Outcome|AD (Sensitivity) Group (Part B)|All evaluated subjects with probable Alzheimer's disease from part B
503023|NCT00750282|O2|Outcome|HV (Specificity) Group (Part A)|All evaluated healthy volunteers from Part A
503024|NCT00750282|O1|Outcome|AD (Sensitivity) Group (Part A)|All evaluated subjects with Alzheimer's disease from Part A
503025|NCT00750282|O2|Outcome|HV (Specificity) Group|All subjects evaluated as healthy volunteer by consensus panel
503026|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All subjects evaluated as probable AD by consensus panel
503027|NCT00750282|O2|Outcome|HV (Specificity) Group|All evaluated healthy volunteers
503028|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All evaluated subjects with Alzheimer's disease
503029|NCT00750282|E4|Reported Event|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503030|NCT00750282|E3|Reported Event|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503031|NCT00750282|E2|Reported Event|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503032|NCT00750282|E1|Reported Event|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
503033|NCT00750269|B6|Baseline|Total|Total of all reporting groups
503034|NCT00750269|B5|Baseline|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503035|NCT00750269|B4|Baseline|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503036|NCT00750269|B3|Baseline|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
503037|NCT00750269|B2|Baseline|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
503038|NCT00750269|B1|Baseline|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
503039|NCT00750269|P5|Participant Flow|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503040|NCT00750269|P4|Participant Flow|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503041|NCT00750269|P3|Participant Flow|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
503042|NCT00750269|P2|Participant Flow|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
503043|NCT00750269|P1|Participant Flow|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
503044|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503045|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503046|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
503047|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
503048|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
503049|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503050|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503051|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
503052|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
503053|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
503054|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503055|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503056|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
503057|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
503058|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
503059|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503060|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503061|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
503062|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
503063|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
503064|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503065|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503066|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
503067|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
503068|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
503069|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503070|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503071|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
503072|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
503073|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
503074|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503075|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503076|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
503077|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
503078|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
503079|NCT00750269|O2|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503080|NCT00750269|O1|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503081|NCT00750269|O1|Outcome|All Participants|
503082|NCT00750269|E5|Reported Event|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
503083|NCT00750269|E4|Reported Event|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
503084|NCT00750269|E3|Reported Event|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
503085|NCT00750269|E2|Reported Event|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
503086|NCT00750269|E1|Reported Event|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
503087|NCT00750204|B3|Baseline|Total|Total of all reporting groups
503088|NCT00750204|B2|Baseline|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
503089|NCT00750204|B1|Baseline|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
503090|NCT00750204|P2|Participant Flow|Conventional MV First|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
503142|NCT00750139|E1|Reported Event|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
503143|NCT00750061|B3|Baseline|Total|Total of all reporting groups
503144|NCT00750061|B2|Baseline|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
503145|NCT00750061|B1|Baseline|Placebo|"Placebo~Placebo: Matching placebo"
504222|NCT00746733|O2|Outcome|Adderall XR|
503091|NCT00750204|P1|Participant Flow|Airway Pressure Release Ventilation (APRV) First|Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude Airway Pressure Release Ventilation •Set FiO2 at 0.1 higher than the setting on conventional MV currently used •Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). •Respiratory rate (RR) to equal 60-65% of RR on conventional MV. •Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20. •Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW. •If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (min Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire
503092|NCT00750204|O2|Outcome|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
503093|NCT00750204|O1|Outcome|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
503094|NCT00750204|E2|Reported Event|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
503095|NCT00750204|E1|Reported Event|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
503096|NCT00750191|B3|Baseline|Total|Total of all reporting groups
503097|NCT00750191|B2|Baseline|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
503098|NCT00750191|B1|Baseline|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
503099|NCT00750191|P2|Participant Flow|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
503100|NCT00750191|P1|Participant Flow|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
503101|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
503102|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
503103|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
504223|NCT00746733|O1|Outcome|Vyvanse|
503104|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
503105|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
503106|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
503107|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
503108|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
503109|NCT00750191|E2|Reported Event|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
503110|NCT00750191|E1|Reported Event|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
503111|NCT00750152|B3|Baseline|Total|Total of all reporting groups
503112|NCT00750152|B2|Baseline|Placebo-2wks|Placebo cream applied daily for 2 weeks
503113|NCT00750152|B1|Baseline|NAFT-500|Naftin 2% cream applied daily for 2 weeks
503114|NCT00750152|P2|Participant Flow|Placebo-2wks|Placebo cream applied daily for 2 weeks
503115|NCT00750152|P1|Participant Flow|NAFT-500|Naftin 2% cream applied daily for 2 weeks
503116|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
503117|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
503118|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
503119|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
503120|NCT00750152|E2|Reported Event|Placebo-2wks|Placebo cream applied daily for 2 weeks
503121|NCT00750152|E1|Reported Event|NAFT-500|Naftin 2% cream applied daily for 2 weeks
503122|NCT00750139|B5|Baseline|Total|Total of all reporting groups
503123|NCT00750139|B4|Baseline|Placebo 4-wks|Placebo cream applied daily for 4 weeks
503124|NCT00750139|B3|Baseline|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
503125|NCT00750139|B2|Baseline|Placebo 2-wks|Placebo applied daily for 2-weeks
503126|NCT00750139|B1|Baseline|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
503127|NCT00750139|P4|Participant Flow|Placebo 4-wks|Placebo cream applied daily for 4 weeks
503128|NCT00750139|P3|Participant Flow|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
503129|NCT00750139|P2|Participant Flow|Placebo 2-wks|Placebo applied daily for 2-weeks
503130|NCT00750139|P1|Participant Flow|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
503131|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo cream applied daily for 4 weeks
503132|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
503133|NCT00750139|O2|Outcome|Placebo 2-wks|Placebo applied daily for 2-weeks
503134|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
503135|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo control cream applied daily for 4 weeks
503136|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
503137|NCT00750139|O2|Outcome|Placebo 2-weeks|Placebo Control cream applied daily for 2-weeks
503138|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
503139|NCT00750139|E4|Reported Event|Placebo 4-wks|Placebo cream applied daily for 4 weeks
503140|NCT00750139|E3|Reported Event|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
503141|NCT00750139|E2|Reported Event|Placebo 2-wks|Placebo applied daily for 2-weeks
503146|NCT00750061|P2|Participant Flow|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
503147|NCT00750061|P1|Participant Flow|Placebo|Placebo: Matching placebo
503148|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
503149|NCT00750061|O1|Outcome|Placebo|"Placebo~Placebo: Matching placebo"
503150|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
503151|NCT00750061|O1|Outcome|Placebo|"Placebo~Placebo: Matching placebo"
503152|NCT00750061|E2|Reported Event|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
503153|NCT00750061|E1|Reported Event|Placebo|Placebo: Matching placebo
503154|NCT00749996|B3|Baseline|Total|Total of all reporting groups
503155|NCT00749996|B2|Baseline|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
503156|NCT00749996|B1|Baseline|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
503157|NCT00749996|P2|Participant Flow|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
503158|NCT00749996|P1|Participant Flow|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
503159|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
503160|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
503161|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
503162|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
503163|NCT00749996|E2|Reported Event|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
503164|NCT00749996|E1|Reported Event|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
503165|NCT00749957|B3|Baseline|Total|Total of all reporting groups
503166|NCT00749957|B2|Baseline|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503167|NCT00749957|B1|Baseline|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503168|NCT00749957|P2|Participant Flow|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503169|NCT00749957|P1|Participant Flow|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503170|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503171|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503172|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503173|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503174|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503175|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503176|NCT00749957|E2|Reported Event|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503177|NCT00749957|E1|Reported Event|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
503178|NCT00749944|B3|Baseline|Total|Total of all reporting groups
503179|NCT00749944|B2|Baseline|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503180|NCT00749944|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503181|NCT00749944|P2|Participant Flow|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503182|NCT00749944|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503183|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503184|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503185|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503186|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503187|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503188|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503189|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503190|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503191|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503192|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503193|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503194|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503195|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503196|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503197|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503198|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503199|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503200|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503201|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503202|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503203|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503204|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503205|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503206|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503207|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503357|NCT00749463|E2|Reported Event|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503208|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503209|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503210|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503211|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503212|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503213|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503214|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503215|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503216|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503217|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503218|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503219|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503220|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503221|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503222|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503223|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503224|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503225|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503226|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503227|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503228|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503229|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503230|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503231|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503232|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503233|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503234|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503235|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503236|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503237|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
504224|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
503238|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503239|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503240|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503241|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503242|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503243|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503244|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503245|NCT00749944|E2|Reported Event|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
503246|NCT00749944|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
503247|NCT00749931|B3|Baseline|Total|Total of all reporting groups
503248|NCT00749931|B2|Baseline|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
503249|NCT00749931|B1|Baseline|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
503250|NCT00749931|P3|Participant Flow|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
503251|NCT00749931|P2|Participant Flow|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
503252|NCT00749931|P1|Participant Flow|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
503253|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
503254|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
503255|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
503256|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
503257|NCT00749931|E3|Reported Event|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
503258|NCT00749931|E2|Reported Event|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
503259|NCT00749931|E1|Reported Event|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
503260|NCT00749775|B1|Baseline|Selara|Participants taking Selara according to Japanese Package Insert.
503261|NCT00749775|P1|Participant Flow|Selara|Participants taking Selara according to Japanese Package Insert.
503262|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
503263|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean diastolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
503264|NCT00749775|O4|Outcome|At 12 Weeks|Mean diastolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
503265|NCT00749775|O3|Outcome|At 8 Weeks|Mean diastolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
503266|NCT00749775|O2|Outcome|At 4 Weeks|Mean diastolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
503267|NCT00749775|O1|Outcome|At Baseline|Mean diastolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
503268|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
503269|NCT00749775|O4|Outcome|At 12 Weeks|Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
503270|NCT00749775|O3|Outcome|At 8 Weeks|Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
503271|NCT00749775|O2|Outcome|At 4 Weeks|Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
503272|NCT00749775|O1|Outcome|At Baseline|Mean systolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
503273|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
503274|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
503275|NCT00749775|E1|Reported Event|Selara|Participants taking Selara according to Japanese Package Insert.
503276|NCT00749684|B1|Baseline|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
503277|NCT00749684|P1|Participant Flow|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
503278|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
503279|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
503280|NCT00749684|E1|Reported Event|Interferon Alfa-2b|
503281|NCT00749671|B3|Baseline|Total|Total of all reporting groups
503282|NCT00749671|B2|Baseline|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
503283|NCT00749671|B1|Baseline|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
503284|NCT00749671|P2|Participant Flow|Ramsey Scale Monitoring|Group assigned to sedation monitoring using the Ramsey Scale for ICD testing
503285|NCT00749671|P1|Participant Flow|Bispectral Index Monitoring|Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.
503286|NCT00749671|O2|Outcome|ICD Testing Ramsey|"Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
503287|NCT00749671|O1|Outcome|ICD Testing BIS|"Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.~Bispectral index monitoring: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
503288|NCT00749671|O2|Outcome|ICD testing2|"Ramsey Sedation Scale~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
503289|NCT00749671|O1|Outcome|ICD Testing|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
503290|NCT00749671|E2|Reported Event|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
503291|NCT00749671|E1|Reported Event|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
503292|NCT00749606|B3|Baseline|Total|Total of all reporting groups
503293|NCT00749606|B2|Baseline|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503294|NCT00749606|B1|Baseline|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503295|NCT00749606|P2|Participant Flow|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503296|NCT00749606|P1|Participant Flow|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503297|NCT00749606|O2|Outcome|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503298|NCT00749606|O1|Outcome|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503299|NCT00749606|O2|Outcome|Group Telephone Intervention|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503300|NCT00749606|O1|Outcome|Individual Telephone Intervention|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503301|NCT00749606|O2|Outcome|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503302|NCT00749606|O1|Outcome|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503303|NCT00749606|O2|Outcome|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503304|NCT00749606|O1|Outcome|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503305|NCT00749606|O2|Outcome|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503306|NCT00749606|O1|Outcome|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503307|NCT00749606|O2|Outcome|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503308|NCT00749606|O1|Outcome|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503309|NCT00749606|O2|Outcome|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503358|NCT00749463|E1|Reported Event|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503359|NCT00749398|B1|Baseline|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503459|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503310|NCT00749606|O1|Outcome|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503311|NCT00749606|E2|Reported Event|Conference Calls|"Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.~Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503312|NCT00749606|E1|Reported Event|Individual Calls|"Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.~Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the coach will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff."
503313|NCT00749580|B3|Baseline|Total|Total of all reporting groups
503314|NCT00749580|B2|Baseline|2: Boosted PI+NRTIs|Group 2 Continue the same regimen without change
503315|NCT00749580|B1|Baseline|1: Boosted PI+RAL|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
503316|NCT00749580|P2|Participant Flow|Controlled|Group 2 Continue the same regimen without change
503317|NCT00749580|P1|Participant Flow|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
503318|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
503319|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
503320|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
503321|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
503322|NCT00749580|E2|Reported Event|Controlled|Group 2 Continue the same regimen without change
503323|NCT00749580|E1|Reported Event|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
503324|NCT00749476|B1|Baseline|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
503325|NCT00749476|P1|Participant Flow|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
503326|NCT00749476|O1|Outcome|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
503327|NCT00749476|E1|Reported Event|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
503328|NCT00749463|B4|Baseline|Total|Total of all reporting groups
503329|NCT00749463|B3|Baseline|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503330|NCT00749463|B2|Baseline|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503331|NCT00749463|B1|Baseline|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503332|NCT00749463|P3|Participant Flow|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503333|NCT00749463|P2|Participant Flow|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503334|NCT00749463|P1|Participant Flow|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503335|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503336|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503337|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503338|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503339|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503340|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503341|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503342|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503343|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503344|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503345|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503346|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503347|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503348|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503349|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503350|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503351|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503352|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503353|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503354|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
503355|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
503356|NCT00749463|E3|Reported Event|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
503360|NCT00749398|P1|Participant Flow|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503361|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503362|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503363|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503364|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503365|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503366|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503367|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503368|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503369|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503370|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503371|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503372|NCT00749398|E1|Reported Event|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
503373|NCT00749268|B5|Baseline|Total|Total of all reporting groups
503374|NCT00749268|B4|Baseline|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
503375|NCT00749268|B3|Baseline|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
503376|NCT00749268|B2|Baseline|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
503377|NCT00749268|B1|Baseline|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
503378|NCT00749268|P2|Participant Flow|Ventral Arm|Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
503379|NCT00749268|P1|Participant Flow|Inguinal Arm|Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
503380|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
503381|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
503382|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
503383|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
503384|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
503385|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
503386|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
503387|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
503388|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
503389|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
503390|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
503391|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
503392|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
503393|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
503394|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
503395|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
503396|NCT00749268|E4|Reported Event|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
503397|NCT00749268|E3|Reported Event|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
503398|NCT00749268|E2|Reported Event|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
503399|NCT00749268|E1|Reported Event|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
503400|NCT00749203|B3|Baseline|Total|Total of all reporting groups
503401|NCT00749203|B2|Baseline|Midazolam the Ketamine|Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on Day 1, then 2 weeks later Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
503402|NCT00749203|B1|Baseline|Ketamine Then Midazolam|Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on Day 1, then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
503403|NCT00749203|P2|Participant Flow|Midazolam Then Ketamine|Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes on day 1, then 2 weeks later, Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
503404|NCT00749203|P1|Participant Flow|Ketamine Then Midazolam|"Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes on day 1,~then 2 weeks later, Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
503405|NCT00749203|O2|Outcome|Midazolam|"single dose 0.045 mg/kg IV infused over 40 minutes~Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
503406|NCT00749203|O1|Outcome|Ketamine|"Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes~Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes"
503407|NCT00749203|O2|Outcome|Midazolam|"single dose 0.045 mg/kg IV infused over 40 minutes~Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
503408|NCT00749203|O1|Outcome|Ketamine|"Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes~Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes"
503409|NCT00749203|O2|Outcome|Midazolam|"single dose 0.045 mg/kg IV infused over 40 minutes~Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
503410|NCT00749203|O1|Outcome|Ketamine|"Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes~Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes"
503411|NCT00749203|O2|Outcome|Midazolam|"single dose 0.045 mg/kg IV infused over 40 minutes~Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
503412|NCT00749203|O1|Outcome|Ketamine|"Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes~Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes"
503413|NCT00749203|O2|Outcome|Midazolam|"single dose 0.045 mg/kg IV infused over 40 minutes~Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes"
503414|NCT00749203|O1|Outcome|Ketamine|"Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes~Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes"
503415|NCT00749203|E2|Reported Event|Midazolam|Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes
503416|NCT00749203|E1|Reported Event|Ketamine|Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes,
503417|NCT00749190|B8|Baseline|Total|Total of all reporting groups
503418|NCT00749190|B7|Baseline|Sitag|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503419|NCT00749190|B6|Baseline|Empa 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503420|NCT00749190|B5|Baseline|Empa 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503421|NCT00749190|B4|Baseline|Empa 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503422|NCT00749190|B3|Baseline|Empa 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503423|NCT00749190|B2|Baseline|Empa 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503424|NCT00749190|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503425|NCT00749190|P7|Participant Flow|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503426|NCT00749190|P6|Participant Flow|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503427|NCT00749190|P5|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503428|NCT00749190|P4|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503429|NCT00749190|P3|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503430|NCT00749190|P2|Participant Flow|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503431|NCT00749190|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503432|NCT00749190|O5|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503433|NCT00749190|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503434|NCT00749190|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503435|NCT00749190|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503436|NCT00749190|O1|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503437|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503438|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503439|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503440|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503441|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503442|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503443|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503444|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503445|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503446|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503447|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503448|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503449|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503450|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503451|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503452|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503453|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503454|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503455|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503456|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503457|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503458|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
504225|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
503460|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503461|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503462|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503463|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503464|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503465|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503466|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503467|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503468|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503469|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503470|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503471|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503472|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503473|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503474|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503475|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503476|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503477|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503478|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503479|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503480|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503481|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503482|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503483|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503484|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503485|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503486|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503487|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503488|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503489|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503490|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503491|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503492|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503493|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503494|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503495|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503496|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503497|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503498|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503499|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503500|NCT00749190|E7|Reported Event|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
503501|NCT00749190|E6|Reported Event|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
503502|NCT00749190|E5|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
503503|NCT00749190|E4|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
503504|NCT00749190|E3|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
503505|NCT00749190|E2|Reported Event|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
503506|NCT00749190|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
503507|NCT00749073|B1|Baseline|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
503508|NCT00749073|P1|Participant Flow|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
503509|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
503605|NCT00748579|E1|Reported Event|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503776|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
504226|NCT00746733|O2|Outcome|Adderall XR|
503510|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. The mean change and standard deviation between baseline (pretreatment) and Month 6 are reported, where a positive value represents the baseline value minus the 6 month value.
503511|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
503512|NCT00749073|E1|Reported Event|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
503513|NCT00748982|B3|Baseline|Total|Total of all reporting groups
503514|NCT00748982|B2|Baseline|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
503515|NCT00748982|B1|Baseline|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
503516|NCT00748982|P2|Participant Flow|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
503517|NCT00748982|P1|Participant Flow|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
503518|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
503519|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
503520|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
503521|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
503522|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
503523|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
503524|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
503525|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
503526|NCT00748982|E2|Reported Event|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
503527|NCT00748982|E1|Reported Event|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
503528|NCT00748969|B3|Baseline|Total|Total of all reporting groups
503529|NCT00748969|B2|Baseline|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
503530|NCT00748969|B1|Baseline|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
503531|NCT00748969|P2|Participant Flow|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
503532|NCT00748969|P1|Participant Flow|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
503533|NCT00748969|O2|Outcome|No Growth Hormone Treatment|Observation only: no growth hormone treatment and no placebo.
503659|NCT00748410|O2|Outcome|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
504227|NCT00746733|O1|Outcome|Vyvanse|
503534|NCT00748969|O1|Outcome|Growth Hormone Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
503535|NCT00748969|E2|Reported Event|No GH Treatment|No placebo/no treatment
503536|NCT00748969|E1|Reported Event|GH Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
503537|NCT00748956|B4|Baseline|Total|Total of all reporting groups
503538|NCT00748956|B3|Baseline|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503539|NCT00748956|B2|Baseline|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503540|NCT00748956|B1|Baseline|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503541|NCT00748956|P3|Participant Flow|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503542|NCT00748956|P2|Participant Flow|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503543|NCT00748956|P1|Participant Flow|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503544|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503545|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503546|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503547|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503548|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503549|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503550|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503551|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503552|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503553|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503554|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503555|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503556|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503557|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503558|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503559|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503560|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503561|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503562|NCT00748956|E3|Reported Event|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
503563|NCT00748956|E2|Reported Event|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
503564|NCT00748956|E1|Reported Event|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
503565|NCT00748865|B1|Baseline|Overall Study|
503566|NCT00748865|P2|Participant Flow|Systane Drops, Then Systane Ultra Drops|Patients first received Systane Drops, then received Systane Ultra Drops
503567|NCT00748865|P1|Participant Flow|Systane Ultra Drops, Then Systane Drops|Patients received Systane Ultra Drops first, then received Systane Drops.
503568|NCT00748865|O2|Outcome|Systane|Systane
503569|NCT00748865|O1|Outcome|Systane Ultra|Systane Ultra
503570|NCT00748865|E2|Reported Event|Systane|Systane
503571|NCT00748865|E1|Reported Event|Systane Ultra|Systane Ultra
503572|NCT00748826|B1|Baseline|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
503573|NCT00748826|P1|Participant Flow|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
503606|NCT00748566|B1|Baseline|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503777|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503574|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
503575|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
503576|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
503577|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
503578|NCT00748826|E1|Reported Event|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
503579|NCT00748709|B1|Baseline|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503580|NCT00748709|P1|Participant Flow|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503581|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503582|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503583|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503584|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503585|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503586|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503587|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503588|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503589|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503590|NCT00748709|E1|Reported Event|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
503591|NCT00748657|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
503592|NCT00748657|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
503593|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
503594|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
503595|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
503596|NCT00748657|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
503597|NCT00748579|B3|Baseline|Total|Total of all reporting groups
503598|NCT00748579|B2|Baseline|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503599|NCT00748579|B1|Baseline|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503600|NCT00748579|P2|Participant Flow|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503601|NCT00748579|P1|Participant Flow|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503602|NCT00748579|O2|Outcome|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503603|NCT00748579|O1|Outcome|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503604|NCT00748579|E2|Reported Event|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
503607|NCT00748566|P1|Participant Flow|Ziprasidone|Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503608|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503609|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503610|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503611|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503612|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503613|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503614|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503615|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503616|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503617|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503618|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503619|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503620|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503621|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503622|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503623|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503624|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503625|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503626|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503778|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503627|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503628|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503629|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503630|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503631|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503632|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503633|NCT00748566|E1|Reported Event|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
503634|NCT00748553|B3|Baseline|Total|Total of all reporting groups
503635|NCT00748553|B2|Baseline|Phase I|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle~Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
503636|NCT00748553|B1|Baseline|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
503637|NCT00748553|P2|Participant Flow|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
503638|NCT00748553|P1|Participant Flow|Phase 1|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle~Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
503639|NCT00748553|O1|Outcome|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
503640|NCT00748553|O1|Outcome|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
503641|NCT00748553|O1|Outcome|Phase II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
503642|NCT00748553|O1|Outcome|Phase 1|"Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle~Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle"
503643|NCT00748553|E1|Reported Event|Phase I and II|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
503644|NCT00748410|B3|Baseline|Total|Total of all reporting groups
503645|NCT00748410|B2|Baseline|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503646|NCT00748410|B1|Baseline|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503647|NCT00748410|P2|Participant Flow|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503648|NCT00748410|P1|Participant Flow|SB656933 20 Milligram (mg)|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 milliliter(mL) of tepid water on every morning of Day 1 to 7 of the treatment period.
503649|NCT00748410|O2|Outcome|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503650|NCT00748410|O1|Outcome|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503651|NCT00748410|O2|Outcome|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503652|NCT00748410|O1|Outcome|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503653|NCT00748410|O2|Outcome|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503654|NCT00748410|O1|Outcome|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503655|NCT00748410|O2|Outcome|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503656|NCT00748410|O1|Outcome|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503657|NCT00748410|O2|Outcome|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503658|NCT00748410|O1|Outcome|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503779|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503660|NCT00748410|O1|Outcome|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503661|NCT00748410|E2|Reported Event|SB656933 100 mg|Participants received SB656933 100 mg (50 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503662|NCT00748410|E1|Reported Event|SB656933 20 mg|Participants received SB656933 20 mg (10 mg per dose ) tablet administered orally with 240 mL of tepid water on every morning of Day 1 to 7 of the treatment period.
503663|NCT00748241|B1|Baseline|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503664|NCT00748241|P1|Participant Flow|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503665|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503666|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503667|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503668|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503669|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503670|NCT00748241|E1|Reported Event|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
503671|NCT00748189|B3|Baseline|Total|Total of all reporting groups
503672|NCT00748189|B2|Baseline|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503673|NCT00748189|B1|Baseline|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503674|NCT00748189|P2|Participant Flow|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503675|NCT00748189|P1|Participant Flow|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503676|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503677|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503678|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503679|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503680|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503681|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503682|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503683|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503684|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503685|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503707|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503686|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503687|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503688|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503689|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503690|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
503691|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503692|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
503693|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503694|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503695|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503696|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503697|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503698|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503699|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503700|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503701|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503702|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503703|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
503704|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503705|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503706|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503774|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503708|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503709|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503710|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503711|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503712|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503713|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503714|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503715|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503716|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503717|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503718|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503719|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503720|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503721|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503722|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503723|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503724|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503725|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503726|NCT00748189|E2|Reported Event|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503727|NCT00748189|E1|Reported Event|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
503775|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503728|NCT00748098|B1|Baseline|All Participants in the Intent-to-Treat (ITT) Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline polysomnography (PSG) efficacy assessment
503729|NCT00748098|P2|Participant Flow|GEn 1200 mg/Day Followed by Placebo|Participants randomized to GEn 1200 mg/day administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day First Taper Period. No treatment was given during 7-day Washout. Matching placebo administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period and the 7-day Second Taper Period. No treatment was given during Follow-up.
503730|NCT00748098|P1|Participant Flow|Placebo Followed by GEn 1200 mg/Day|Participants randomized to matching placebo administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period and the 7-day First Taper Period. No treatment was given during the 7-day Washout. Gabapentin enacarbil (GEn) 1200 mg/day administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day Second Taper Period. No treatment was given during Follow-up.
503731|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503732|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503733|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503734|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
503735|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503736|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503737|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503738|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503739|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503740|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
503741|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503742|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503743|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503744|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503745|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503746|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503747|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503748|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503749|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503750|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503751|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503752|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503753|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503754|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503755|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503756|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503757|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503758|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503759|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503760|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
503761|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503762|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503763|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503764|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503765|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503766|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503767|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503768|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503769|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503770|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503771|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503772|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503773|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
504228|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
503780|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503781|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503782|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503783|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503784|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503785|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
503786|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
503787|NCT00748098|E2|Reported Event|GEn 1200 mg|Participants who took at least one dose of GEn 1200 mg in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 127 took at least one dose of GEn 1200 mg.
503788|NCT00748098|E1|Reported Event|Placebo|Participants who took at least one dose of placebo in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 132 took at least one dose of placebo.
503789|NCT00748085|B1|Baseline|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
503790|NCT00748085|P1|Participant Flow|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
503791|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
503792|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
503793|NCT00748085|E1|Reported Event|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
503794|NCT00748072|B3|Baseline|Total|Total of all reporting groups
503795|NCT00748072|B2|Baseline|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
503796|NCT00748072|B1|Baseline|Saline Solution|patients treated with 1 ml of s.c. saline solution
503797|NCT00748072|P2|Participant Flow|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
503798|NCT00748072|P1|Participant Flow|Saline Solution|patients treated with 1 ml of s.c. saline solution
503799|NCT00748072|O2|Outcome|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
503800|NCT00748072|O1|Outcome|Saline Solution|patients treated with 1 ml of s.c. saline solution
503801|NCT00748072|E2|Reported Event|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
503802|NCT00748072|E1|Reported Event|Saline Solution|patients treated with 1 ml of s.c. saline solution
503803|NCT00747916|B1|Baseline|All Participants ICE PLS|
503804|NCT00747916|P1|Participant Flow|All Participants ICE PLS|The study consists of one arm. All subjects enrolled in All participants ICE PLS
503805|NCT00747916|O1|Outcome|All Participants ICE PLS|
503806|NCT00747916|O1|Outcome|All Participants ICE PLS|
503807|NCT00747916|E1|Reported Event|All Participants ICE PLS|
503808|NCT00747812|B3|Baseline|Total|Total of all reporting groups
503809|NCT00747812|B2|Baseline|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
503810|NCT00747812|B1|Baseline|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
503811|NCT00747812|P2|Participant Flow|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
503812|NCT00747812|P1|Participant Flow|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
503813|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
503814|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
503815|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
503816|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
503817|NCT00747812|E2|Reported Event|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
503818|NCT00747812|E1|Reported Event|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
503819|NCT00747747|B4|Baseline|Total|Total of all reporting groups
503820|NCT00747747|B3|Baseline|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
503821|NCT00747747|B2|Baseline|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
503822|NCT00747747|B1|Baseline|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503823|NCT00747747|P3|Participant Flow|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
503824|NCT00747747|P2|Participant Flow|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
503825|NCT00747747|P1|Participant Flow|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503826|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
503827|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
503828|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503829|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
503830|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
503831|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503832|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
503833|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
503834|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503835|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
503836|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
503837|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503838|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
503839|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
503840|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503841|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
503842|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
503843|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503844|NCT00747747|E3|Reported Event|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
503845|NCT00747747|E2|Reported Event|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
503846|NCT00747747|E1|Reported Event|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
503847|NCT00747643|B3|Baseline|Total|Total of all reporting groups
503848|NCT00747643|B2|Baseline|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
503902|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503849|NCT00747643|B1|Baseline|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
503850|NCT00747643|P2|Participant Flow|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
503851|NCT00747643|P1|Participant Flow|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
503852|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
503853|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
503854|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
503855|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
503856|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
503857|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
503858|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
503859|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
503860|NCT00747643|E2|Reported Event|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
503861|NCT00747643|E1|Reported Event|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
503862|NCT00747617|B3|Baseline|Total|Total of all reporting groups
503863|NCT00747617|B2|Baseline|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
503864|NCT00747617|B1|Baseline|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
503865|NCT00747617|P2|Participant Flow|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
503866|NCT00747617|P1|Participant Flow|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
503867|NCT00747617|O2|Outcome|Normal|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
503868|NCT00747617|O1|Outcome|PCOS|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
503869|NCT00747617|E2|Reported Event|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
503870|NCT00747617|E1|Reported Event|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
503871|NCT00747565|B3|Baseline|Total|Total of all reporting groups
503872|NCT00747565|B2|Baseline|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
503873|NCT00747565|B1|Baseline|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
503874|NCT00747565|P2|Participant Flow|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
503875|NCT00747565|P1|Participant Flow|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
503876|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
503877|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
503878|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
503879|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
503880|NCT00747565|E2|Reported Event|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
503881|NCT00747565|E1|Reported Event|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects.
503882|NCT00747552|B1|Baseline|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
503903|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504229|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
503883|NCT00747552|P1|Participant Flow|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
503884|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
503885|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
503886|NCT00747552|E1|Reported Event|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
503887|NCT00747474|B1|Baseline|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503888|NCT00747474|P12|Participant Flow|Cohort 12 (60 mg/m^2)|Participants received 60 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503889|NCT00747474|P11|Participant Flow|Cohort 11 (50 mg/m^2)|Participants received 50 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503890|NCT00747474|P10|Participant Flow|Cohort 10 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503891|NCT00747474|P9|Participant Flow|Cohort 9 (35 mg/m^2)|Participants received 35 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503892|NCT00747474|P8|Participant Flow|Cohort 8 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503893|NCT00747474|P7|Participant Flow|Cohort 7 (30 mg/m^2)|Participants received 30 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503894|NCT00747474|P6|Participant Flow|Cohort 6 (20 mg/m^2)|Participants received 20 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503895|NCT00747474|P5|Participant Flow|Cohort 5 (13.5 mg/m^2)|Participants received 13.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503896|NCT00747474|P4|Participant Flow|Cohort 4 (9 mg/m^2)|Participants received 9 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503897|NCT00747474|P3|Participant Flow|Cohort 3 (6 mg/m^2)|Participants received 6 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503898|NCT00747474|P2|Participant Flow|Cohort 2 (3 mg/m^2)|Participants received 3 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503899|NCT00747474|P1|Participant Flow|Cohort 1 (1.5 mg/m^2)|Participants received 1.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
503900|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503901|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
504009|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
503904|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503905|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503906|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503907|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503908|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503909|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503910|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503911|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503912|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503913|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503914|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503915|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503916|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503917|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503918|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503919|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503920|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503921|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503922|NCT00747474|O1|Outcome|All Participants|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle according to the dose assigned.
503923|NCT00747474|E1|Reported Event|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
503924|NCT00747461|B1|Baseline|Cryo Spray Ablation|subjects will receive up to 4 -5 second cycles of cryospray ablation
503925|NCT00747461|P1|Participant Flow|Cryo Spray Ablation|subjects receiving up to 4 -5 second spray cycles
503926|NCT00747461|O1|Outcome|Cryo Spray Ablation|subjects receiving cryo spray ablation
503927|NCT00747461|O1|Outcome|Cryo Spray Ablation|Subject receiving cryo spray ablation
503928|NCT00747461|E1|Reported Event|All Subjects Receiving CSA Cryospray|"All subjects enrolled will received CSA cryospray.~CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system."
503929|NCT00747435|B1|Baseline|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503930|NCT00747435|P1|Participant Flow|Original Audiological Criteria|"Originally the study was designed to have two ARMs, but the second study ARM did not fully enroll. At the time of submission, the data for both ARMs was collapsed and data analysis was completed on all subjects as one group. The below inclusion criteria represents both ARMs as one group.~Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503931|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503932|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503933|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503934|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503935|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503936|NCT00747435|E1|Reported Event|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
503937|NCT00747344|B3|Baseline|Total|Total of all reporting groups
503938|NCT00747344|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
503939|NCT00747344|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
503940|NCT00747344|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
503941|NCT00747344|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
503942|NCT00747344|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
503943|NCT00747344|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
503944|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
503945|NCT00747344|O1|Outcome|Placebo|
503946|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
503947|NCT00747344|O1|Outcome|Placebo|
503948|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
503949|NCT00747344|O1|Outcome|Placebo|
503950|NCT00747344|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
503951|NCT00747344|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
503952|NCT00747344|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
503953|NCT00747344|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
503954|NCT00747227|B3|Baseline|Total|Total of all reporting groups
503955|NCT00747227|B2|Baseline|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
503956|NCT00747227|B1|Baseline|ZV9003 Intraocular Lens|modified light transmission intraocular lens
503957|NCT00747227|P2|Participant Flow|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
503958|NCT00747227|P1|Participant Flow|ZV9003 Intraocular Lens|modified light transmission intraocular lens
503959|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
503960|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
503961|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
503962|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
503963|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
503964|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
503965|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
503966|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
503967|NCT00747227|E2|Reported Event|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
503968|NCT00747227|E1|Reported Event|ZV9003 Intraocular Lens|modified light transmission intraocular lens
503969|NCT00747214|B3|Baseline|Total|Total of all reporting groups
503970|NCT00747214|B2|Baseline|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
503971|NCT00747214|B1|Baseline|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
503972|NCT00747214|P2|Participant Flow|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
503973|NCT00747214|P1|Participant Flow|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone)~Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
503974|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
503975|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
503976|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
503977|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
503978|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
504010|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
503979|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
503980|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
503981|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
503982|NCT00747214|E2|Reported Event|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
503983|NCT00747214|E1|Reported Event|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) or placebo equivalent Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone) or placebo equivalent"
503984|NCT00747149|B3|Baseline|Total|Total of all reporting groups
503985|NCT00747149|B2|Baseline|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
503986|NCT00747149|B1|Baseline|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
503987|NCT00747149|P2|Participant Flow|Rosuvastatin Non-titrated|10 mg RSV or 20 mg RSV
503988|NCT00747149|P1|Participant Flow|Rosuvastatin Titrated|10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
503989|NCT00747149|O4|Outcome|Rosuvastatin 40 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
503990|NCT00747149|O3|Outcome|Rosuvastatin 20 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
503991|NCT00747149|O2|Outcome|Rosuvastatin 20 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
503992|NCT00747149|O1|Outcome|Rosuvastatin 10 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
503993|NCT00747149|E6|Reported Event|Rosuvastatin 40 mg (Titrated)|20 mg RSV as titrated dose
503994|NCT00747149|E5|Reported Event|Rosuvastatin 20 mg (Titrated)|20 mg RSV as titrated dose
503995|NCT00747149|E4|Reported Event|Rosuvastatin 20 mg (Continued, Non-titrated)|20 mg RSV as continued, non-titrated dose
503996|NCT00747149|E3|Reported Event|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
503997|NCT00747149|E2|Reported Event|Rosuvastatin 10 mg (Continued, Non-titrated)|10 mg RSV as a continued, non-titrated dose
503998|NCT00747149|E1|Reported Event|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
503999|NCT00747006|B4|Baseline|Total|Total of all reporting groups
504000|NCT00747006|B3|Baseline|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
504001|NCT00747006|B2|Baseline|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
504002|NCT00747006|B1|Baseline|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
504003|NCT00747006|P3|Participant Flow|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
504004|NCT00747006|P2|Participant Flow|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
504005|NCT00747006|P1|Participant Flow|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
504006|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504007|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504008|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504011|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504012|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504013|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504014|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504015|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504016|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504017|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504018|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504019|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504020|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504021|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504022|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504023|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504024|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504025|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504026|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504027|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504028|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504029|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504030|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504031|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504032|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504033|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504034|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504035|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504036|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504037|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504038|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504039|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504040|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504041|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504042|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504043|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504044|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504045|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504046|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504047|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504048|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504049|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504050|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504051|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504052|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504053|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504054|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504055|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504056|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504057|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504058|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504059|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504060|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504061|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
504062|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
504063|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
504064|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
504065|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
504066|NCT00747006|E4|Reported Event|Humalog Amendment 1 Type 2 DM|Humalog treated subjects in protocol amendment 1
504067|NCT00747006|E3|Reported Event|TI Amendment 1 Type 2 DM|Technosphere Insulin treated subjects in protocol amendment 1
504068|NCT00747006|E2|Reported Event|TI Original Protocol Type 2 DM|Original protocol type 2 diabetes mellitus subjects
504230|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504069|NCT00747006|E1|Reported Event|TI Original Protocol Type 1 DM|Original protocol type 1 diabetes mellitus subjects
504070|NCT00746954|B1|Baseline|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
504071|NCT00746954|P3|Participant Flow|Arm 3 BUS to ACET to PLA|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
504072|NCT00746954|P2|Participant Flow|Arm 2 Acet to Placebo to Bus|Each patient will act as their own control, with comparisons over three nights, each night given actetazolamide (Acet 250mg), or placebo or buspirone (Bus 20mg),
504073|NCT00746954|P1|Participant Flow|Arm 1 Control to ACET to BUS|Each patient will act as their own control, with comparisons over three nights, this is placebo
504074|NCT00746954|O3|Outcome|PLACEBO|Each patient will act as their own control, with comparisons over three nights
504075|NCT00746954|O2|Outcome|ACETAZOLAMIDE|Each patient will act as their own control, with comparisons over three nights
504076|NCT00746954|O1|Outcome|BUSPIRONE|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
504077|NCT00746954|E1|Reported Event|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
504078|NCT00746941|B5|Baseline|Total|Total of all reporting groups
504079|NCT00746941|B4|Baseline|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504080|NCT00746941|B3|Baseline|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
504081|NCT00746941|B2|Baseline|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
504082|NCT00746941|B1|Baseline|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
504083|NCT00746941|P4|Participant Flow|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504084|NCT00746941|P3|Participant Flow|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
504085|NCT00746941|P2|Participant Flow|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
504086|NCT00746941|P1|Participant Flow|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
504087|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|"Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.~Also includes participants who were randomized to receive local standard of care (only) and added mefloquine at Week 4 or Week 8."
504088|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504089|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504090|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504091|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504092|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504119|NCT00746889|O1|Outcome|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
504093|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504094|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504095|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504096|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504097|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504098|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504099|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504100|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504101|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504102|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504103|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504104|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504105|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504106|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
504107|NCT00746941|E4|Reported Event|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
504108|NCT00746941|E3|Reported Event|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 8 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
504109|NCT00746941|E2|Reported Event|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 4 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
504110|NCT00746941|E1|Reported Event|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Weeks 4 or 8 to their standard of care treatment are counted in this treatment arm until the time of switching to mefloquine treatment."
504111|NCT00746889|B3|Baseline|Total|Total of all reporting groups
504112|NCT00746889|B2|Baseline|Placebo|Intraarticular injection of 0.9% saline
504113|NCT00746889|B1|Baseline|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
504114|NCT00746889|P2|Participant Flow|Placebo|Intraarticular injection of 0.9% saline
504115|NCT00746889|P1|Participant Flow|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
504116|NCT00746889|O2|Outcome|Noninflammatory Patients Who Received Corticosteroid Injection|Patients with noninflammatory characteristics on ultrasound who received saline placebo knee injections
504117|NCT00746889|O1|Outcome|Inflammatory Patients Who Received Corticosteroid Injections|Patients with inflammatory characteristics on ultrsaound who were treated with corticosteroid knee injections
504118|NCT00746889|O2|Outcome|Placebo|Intraarticular injection of 0.9% saline
504121|NCT00746889|E1|Reported Event|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
504122|NCT00746863|B3|Baseline|Total|Total of all reporting groups
504123|NCT00746863|B2|Baseline|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504124|NCT00746863|B1|Baseline|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504125|NCT00746863|P2|Participant Flow|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504126|NCT00746863|P1|Participant Flow|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504127|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504128|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504129|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504130|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504131|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504132|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504133|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504134|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504135|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504136|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504137|NCT00746863|E2|Reported Event|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
504138|NCT00746863|E1|Reported Event|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
504139|NCT00746798|B5|Baseline|Total|Total of all reporting groups
504140|NCT00746798|B4|Baseline|Placebo|Participants who received placebo (saline) given one time subcutaneously
504141|NCT00746798|B3|Baseline|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
504142|NCT00746798|B2|Baseline|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
504143|NCT00746798|B1|Baseline|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
504144|NCT00746798|P4|Participant Flow|Placebo|Participants who received placebo (saline) given one time subcutaneously
504145|NCT00746798|P3|Participant Flow|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
504146|NCT00746798|P2|Participant Flow|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
504147|NCT00746798|P1|Participant Flow|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
504148|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
504149|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
504150|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
504151|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
504152|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
504153|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
504154|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
504155|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
504156|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
504157|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
504158|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
504159|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
504160|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
504161|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
504162|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
504163|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
504164|NCT00746798|E4|Reported Event|Placebo|Participants who received placebo (saline) given one time subcutaneously
504165|NCT00746798|E3|Reported Event|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
504166|NCT00746798|E2|Reported Event|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
504167|NCT00746798|E1|Reported Event|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
504168|NCT00746785|B4|Baseline|Total|Total of all reporting groups
504169|NCT00746785|B3|Baseline|C - Placebo|placebo : placebo
504170|NCT00746785|B2|Baseline|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
504171|NCT00746785|B1|Baseline|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
504172|NCT00746785|P3|Participant Flow|C - Placebo|placebo : placebo
504173|NCT00746785|P2|Participant Flow|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
504174|NCT00746785|P1|Participant Flow|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
504175|NCT00746785|O3|Outcome|C - Placebo|placebo : placebo
504176|NCT00746785|O2|Outcome|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
504177|NCT00746785|O1|Outcome|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
504178|NCT00746785|E3|Reported Event|C - Placebo|placebo : placebo
504179|NCT00746785|E2|Reported Event|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
504180|NCT00746785|E1|Reported Event|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
504181|NCT00746733|B1|Baseline|Entire Study Population|
504182|NCT00746733|P2|Participant Flow|Adderall XR First|Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
504183|NCT00746733|P1|Participant Flow|Vyvanse First|Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention.
504184|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504185|NCT00746733|O1|Outcome|Adderall XR|
504186|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504187|NCT00746733|O1|Outcome|Adderall XR|
504188|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504189|NCT00746733|O1|Outcome|Adderall XR|
504190|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504191|NCT00746733|O1|Outcome|Adderall XR|
504192|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504193|NCT00746733|O1|Outcome|Adderall XR|
504194|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504195|NCT00746733|O1|Outcome|Adderall XR|
504196|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504197|NCT00746733|O1|Outcome|Adderall XR|
504198|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
504199|NCT00746733|O1|Outcome|Adderall XR|
504200|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
504201|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
504202|NCT00746733|O2|Outcome|Adderall XR|
504203|NCT00746733|O1|Outcome|Vyvanse|
504204|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
504205|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
504206|NCT00746733|O2|Outcome|Adderall XR|
504207|NCT00746733|O1|Outcome|Vyvanse|
504208|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
504209|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
504210|NCT00746733|O2|Outcome|Adderall XR|
504211|NCT00746733|O1|Outcome|Vyvanse|
504212|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
504213|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
504242|NCT00746694|B1|Baseline|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
504243|NCT00746694|P1|Participant Flow|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
504244|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
504245|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
504246|NCT00746694|E1|Reported Event|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
504247|NCT00746668|B1|Baseline|All Study Participants|All subjects' reading performances were initially assessed before training began. Reading performance were assessed using sentences displayed on a computer monitor. Two lines of text were presented at the center of the monitor with each subject seated at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test.
504248|NCT00746668|P7|Participant Flow|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
504249|NCT00746668|P6|Participant Flow|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
504250|NCT00746668|P5|Participant Flow|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
504251|NCT00746668|P4|Participant Flow|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
504252|NCT00746668|P3|Participant Flow|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
504253|NCT00746668|P2|Participant Flow|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
504254|NCT00746668|P1|Participant Flow|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
504255|NCT00746668|O4|Outcome|Arm 4: Assessment After Module 3|Assessment after six-weeks of training in Module 3 (RSVP Reading).
504256|NCT00746668|O3|Outcome|Arm 3: Assessment After Module 2|Assessment after six-weeks of training in Module 2 (Eye Movement Training).
504257|NCT00746668|O2|Outcome|Arm 2: Assessment After Module 1|Assessment after six-weeks of training in Module 1 (PRL Awareness Training).
504258|NCT00746668|O1|Outcome|Arm 1: Pre-Training|Baseline Assessment prior to training.
504259|NCT00746668|E7|Reported Event|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
504306|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
504260|NCT00746668|E6|Reported Event|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
504261|NCT00746668|E5|Reported Event|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
504262|NCT00746668|E4|Reported Event|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
504263|NCT00746668|E3|Reported Event|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
504264|NCT00746668|E2|Reported Event|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
504265|NCT00746668|E1|Reported Event|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
504266|NCT00746590|B1|Baseline|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
504267|NCT00746590|P1|Participant Flow|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
504268|NCT00746590|O1|Outcome|Prolarix Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
504269|NCT00746590|E1|Reported Event|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
504270|NCT00746564|B1|Baseline|Open Label|All patients who were implanted with the SJM Confirm device.
504271|NCT00746564|P1|Participant Flow|SJM Confirm Device|All patients in this study received the St. Jude Medical (SJM Confirm device.
504272|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with the SJM Confirm device.
504273|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
504274|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
504275|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504276|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504277|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504278|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504279|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504280|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504281|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504282|NCT00746564|E1|Reported Event|SJM Confirm Device|All patients in this study received the SJM Confirm device.
504283|NCT00746551|B3|Baseline|Total|Total of all reporting groups
504284|NCT00746551|B2|Baseline|Ferrous Fumarate, Ferri-6, Oral Tablet|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
504304|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504285|NCT00746551|B1|Baseline|Iron Sucrose, Venofer, Intravenous Drug|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
504286|NCT00746551|P2|Participant Flow|Ferrous Fumarate, Ferri-6®, Oral Tablet|In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
504287|NCT00746551|P1|Participant Flow|Iron Sucrose, Venofer®, Intravenous Drug|Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
504288|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
504289|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
504290|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
504291|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
504292|NCT00746551|E2|Reported Event|Ferrous Fumarate, Ferri-6®, Oral Tablet|Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
504293|NCT00746551|E1|Reported Event|Iron Sucrose, Venofer®, Intravenous Drug|"In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
504294|NCT00746512|B5|Baseline|Total|Total of all reporting groups
504295|NCT00746512|B4|Baseline|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504296|NCT00746512|B3|Baseline|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504297|NCT00746512|B2|Baseline|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
504298|NCT00746512|B1|Baseline|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
504299|NCT00746512|P4|Participant Flow|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504300|NCT00746512|P3|Participant Flow|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504301|NCT00746512|P2|Participant Flow|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
504302|NCT00746512|P1|Participant Flow|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
504303|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504305|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
504307|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504308|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504309|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
504310|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
504311|NCT00746512|E4|Reported Event|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504312|NCT00746512|E3|Reported Event|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
504313|NCT00746512|E2|Reported Event|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
504314|NCT00746512|E1|Reported Event|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
504315|NCT00746421|B3|Baseline|Total|Total of all reporting groups
504316|NCT00746421|B2|Baseline|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
504317|NCT00746421|B1|Baseline|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
504318|NCT00746421|P2|Participant Flow|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
504319|NCT00746421|P1|Participant Flow|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
504320|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
504321|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
504322|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
504323|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
504324|NCT00746421|E2|Reported Event|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
504325|NCT00746421|E1|Reported Event|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
504326|NCT00746395|B3|Baseline|Total|Total of all reporting groups
504327|NCT00746395|B2|Baseline|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
504328|NCT00746395|B1|Baseline|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
504329|NCT00746395|P2|Participant Flow|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
504330|NCT00746395|P1|Participant Flow|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
504331|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
504332|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
504333|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
504334|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
504335|NCT00746395|E2|Reported Event|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
504336|NCT00746395|E1|Reported Event|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
504337|NCT00746356|B1|Baseline|All Patients|All patients enrolled in the study
504338|NCT00746356|P2|Participant Flow|ICD Device Patients|All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.
504339|NCT00746356|P1|Participant Flow|CRT-D Device Patients|All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.
504340|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle.
504341|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle
504342|NCT00746356|O1|Outcome|Participants With Single or Dual Chamber ICDs|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold in the right ventricle
504343|NCT00746356|O1|Outcome|Participants With Dual Chamber ICDs or CRTD Devices|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold
504344|NCT00746356|O1|Outcome|Participants Successfully Implanted With Devices|All participants successfully implanted with an ICD or CRT-D
504345|NCT00746356|E1|Reported Event|All Patients|All patients enrolled in the study
504346|NCT00746330|B5|Baseline|Total|Total of all reporting groups
504347|NCT00746330|B4|Baseline|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504373|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
504374|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
504375|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
504376|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
504377|NCT00746330|E4|Reported Event|Placebo|Placebo via pMDI/ Placebo via DPI
504378|NCT00746330|E3|Reported Event|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
504348|NCT00746330|B3|Baseline|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504349|NCT00746330|B2|Baseline|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504350|NCT00746330|B1|Baseline|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504351|NCT00746330|P4|Participant Flow|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504352|NCT00746330|P3|Participant Flow|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504353|NCT00746330|P2|Participant Flow|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504354|NCT00746330|P1|Participant Flow|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via Pressurized Metered Dose Inhaler (pMDI) + placebo to formoterol fumarate via Dry Powder Inhaler (DPI); Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
504355|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
504356|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
504357|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
504358|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
504359|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
504360|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
504361|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
504362|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
504363|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
504364|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
504365|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
504366|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
504367|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
504368|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
504369|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
504370|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
504371|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
504372|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
504379|NCT00746330|E2|Reported Event|F12D|Placebo Via pMDI/ Formoterol Fumarate 12 μg Via DPI
504380|NCT00746330|E1|Reported Event|F12M|Formoterol Fumarate 12 μg Via pMDI/ Placebo Via DPI
504381|NCT00746252|B3|Baseline|Total|Total of all reporting groups
504382|NCT00746252|B2|Baseline|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
504383|NCT00746252|B1|Baseline|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
504384|NCT00746252|P2|Participant Flow|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
504385|NCT00746252|P1|Participant Flow|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
504386|NCT00746252|O2|Outcome|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
504387|NCT00746252|O1|Outcome|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
504388|NCT00746252|E2|Reported Event|Aripiprazole|"aripiprazole~aripiprazole: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months."
504389|NCT00746252|E1|Reported Event|Risperidone|"risperidone~risperidone: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing."
504390|NCT00746239|B1|Baseline|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record.
504391|NCT00746239|P1|Participant Flow|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Subjects were randomly assigned to receive either Ramelteon 8 mg and Escitalopram (5-40 mg) OR Placebo and Escitalopram (5-40 mg). However, as the blind was never opened, we are combining all subjects in one group for presenting in this record.
504392|NCT00746239|O1|Outcome|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
504393|NCT00746239|O1|Outcome|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
504394|NCT00746239|E1|Reported Event|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|"Panic disorder subjects who were on Escitalopram received either Escitalopram OR Placebo - as the study terminated prematurely, the blind was never opened; thus it is not known as to how many were in each arm- as a result we are not combining all in one group for presenting in this record.~Ramelteon and Escitalopram: Ramelteon 8 mg and Escitalopram (5-40 mg)"
504395|NCT00746187|B3|Baseline|Total|Total of all reporting groups
504396|NCT00746187|B2|Baseline|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
504397|NCT00746187|B1|Baseline|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
504398|NCT00746187|P2|Participant Flow|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
504399|NCT00746187|P1|Participant Flow|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
504400|NCT00746187|O2|Outcome|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
504401|NCT00746187|O1|Outcome|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
504402|NCT00746187|E2|Reported Event|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
504403|NCT00746187|E1|Reported Event|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
504404|NCT00746096|B3|Baseline|Total|Total of all reporting groups
504405|NCT00746096|B2|Baseline|Placebo|Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
504406|NCT00746096|B1|Baseline|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
504407|NCT00746096|P2|Participant Flow|Placebo|"Patient received placebo orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
504408|NCT00746096|P1|Participant Flow|IKH-01|"Patient received IKH-01 orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
504409|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
504410|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
504411|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
504412|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
504413|NCT00746096|E2|Reported Event|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
526171|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
504414|NCT00746096|E1|Reported Event|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
504415|NCT00746018|B1|Baseline|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
504416|NCT00746018|P1|Participant Flow|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
504417|NCT00746018|O1|Outcome|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
504418|NCT00746018|E1|Reported Event|Total Hysterectomy|The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
504419|NCT00745940|B3|Baseline|Total|Total of all reporting groups
504420|NCT00745940|B2|Baseline|MBCT Control Group|Control group waited.
504421|NCT00745940|B1|Baseline|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504422|NCT00745940|P2|Participant Flow|MBCT Control Group|Control group waited.
504423|NCT00745940|P1|Participant Flow|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504424|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
504425|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504426|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
504427|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504428|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
504429|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504430|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
504431|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504432|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
504466|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
506191|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
504433|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504434|NCT00745940|E2|Reported Event|MBCT Control Group|Control group waited.
504435|NCT00745940|E1|Reported Event|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
504436|NCT00745901|B3|Baseline|Total|Total of all reporting groups
504437|NCT00745901|B2|Baseline|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504438|NCT00745901|B1|Baseline|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504439|NCT00745901|P2|Participant Flow|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504440|NCT00745901|P1|Participant Flow|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504441|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504442|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504443|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504444|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504445|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504446|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504447|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504448|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504449|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504450|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504451|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504452|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504453|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504454|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504455|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504456|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504457|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504458|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504459|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504460|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504461|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504462|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504463|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504464|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504465|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
507610|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
504467|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504468|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504469|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504470|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504471|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504472|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504473|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504474|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504475|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504476|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504477|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504478|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504479|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504480|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504481|NCT00745901|E2|Reported Event|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
504482|NCT00745901|E1|Reported Event|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
504483|NCT00745875|B3|Baseline|Total|Total of all reporting groups
504484|NCT00745875|B2|Baseline|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
504485|NCT00745875|B1|Baseline|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
504486|NCT00745875|P2|Participant Flow|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
504487|NCT00745875|P1|Participant Flow|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
504488|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
504489|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
504490|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
504491|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
504492|NCT00745875|E2|Reported Event|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
504493|NCT00745875|E1|Reported Event|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
504494|NCT00745823|B3|Baseline|Total|Total of all reporting groups
504495|NCT00745823|B2|Baseline|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504496|NCT00745823|B1|Baseline|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504497|NCT00745823|P2|Participant Flow|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504498|NCT00745823|P1|Participant Flow|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504499|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504500|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504501|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504502|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504503|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg b.i.d. administered with TRUVADA™
504504|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg PO q.d. plus placebo to raltegravir PO b.i.d. plus one tablet of TRUVADA™ for 96 weeks
504505|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504506|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504507|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504555|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504508|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504509|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504510|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504511|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504512|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504513|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504514|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504515|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504516|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504517|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504518|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504519|NCT00745823|E2|Reported Event|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
504520|NCT00745823|E1|Reported Event|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
504521|NCT00745498|B4|Baseline|Total|Total of all reporting groups
504522|NCT00745498|B3|Baseline|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
504523|NCT00745498|B2|Baseline|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
504524|NCT00745498|B1|Baseline|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
504525|NCT00745498|P3|Participant Flow|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
504526|NCT00745498|P2|Participant Flow|Introp IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
504527|NCT00745498|P1|Participant Flow|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
504528|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
504529|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
504530|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
504531|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
504532|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
504533|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
504534|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
504535|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
504536|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
504537|NCT00745498|E3|Reported Event|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
504538|NCT00745498|E2|Reported Event|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
504539|NCT00745498|E1|Reported Event|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
504540|NCT00745420|B1|Baseline|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504541|NCT00745420|P1|Participant Flow|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504542|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504543|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504544|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504545|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504546|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504547|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504548|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504549|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504550|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504551|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504552|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504553|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504554|NCT00745420|O1|Outcome|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504556|NCT00745420|E1|Reported Event|Hematopoietic Stem Cell Transplantation|Bone Marrow Transplant with GVHD Prophylaxis Regimen
504557|NCT00745368|B1|Baseline|Raltegravir|Raltegravir 400 mg tablets twice daily
504558|NCT00745368|P1|Participant Flow|Raltegravir|Raltegravir 400 mg tablets twice daily
504559|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504560|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504561|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504562|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504563|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504564|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504565|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504566|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
504567|NCT00745368|E1|Reported Event|Raltegravir|Raltegravir 400 mg tablets twice daily
504568|NCT00745290|B3|Baseline|Total|Total of all reporting groups
504569|NCT00745290|B2|Baseline|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
504570|NCT00745290|B1|Baseline|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
504571|NCT00745290|P2|Participant Flow|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
504572|NCT00745290|P1|Participant Flow|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
504573|NCT00745290|O2|Outcome|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
504574|NCT00745290|O1|Outcome|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
504575|NCT00745290|E2|Reported Event|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
504576|NCT00745290|E1|Reported Event|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
504577|NCT00745251|B3|Baseline|Total|Total of all reporting groups
504578|NCT00745251|B2|Baseline|Top Dose|PHEN/TPM 15mg/92mg
504579|NCT00745251|B1|Baseline|Placebo|
504580|NCT00745251|P2|Participant Flow|Top Dose|PHEN/TPM 15mg/92mg
504581|NCT00745251|P1|Participant Flow|Placebo|
504582|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
504583|NCT00745251|O1|Outcome|Placebo|
504584|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
504585|NCT00745251|O1|Outcome|Placebo|
504586|NCT00745251|E2|Reported Event|Top Dose|PHEN/TPM 15mg/92mg
504587|NCT00745251|E1|Reported Event|Placebo|
504588|NCT00745095|B7|Baseline|Total|Total of all reporting groups
504589|NCT00745095|B6|Baseline|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
504590|NCT00745095|B5|Baseline|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
504591|NCT00745095|B4|Baseline|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504592|NCT00745095|B3|Baseline|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
504593|NCT00745095|B2|Baseline|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504594|NCT00745095|B1|Baseline|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)
504595|NCT00745095|P6|Participant Flow|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate [NG])
504596|NCT00745095|P5|Participant Flow|Control MoviPrep® Only|(Control, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] only (no neostigmine plus glycopyrrolate [NG])
504597|NCT00745095|P4|Participant Flow|SCI PIEE (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504598|NCT00745095|P3|Participant Flow|SCI PIEE (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate [NG])
504599|NCT00745095|P2|Participant Flow|SCI MoviPrep® (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504600|NCT00745095|P1|Participant Flow|SCI MoviPrep® (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50 and SCI, GFR>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG])
504601|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
504602|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
504603|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504604|NCT00745095|O3|Outcome|SCI PIEE ( Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
504605|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504606|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® ( without NG)
504607|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
504608|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
526172|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
504609|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504610|NCT00745095|O3|Outcome|SCI PIEE (Without NG)|"(SCI, GFR>=50ml/min) PIEE (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504611|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (withNG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504612|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50 and GFR >=50) MoviPrep® (without NG)
504613|NCT00745095|E6|Reported Event|SCI PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
504614|NCT00745095|E5|Reported Event|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
504615|NCT00745095|E4|Reported Event|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504616|NCT00745095|E3|Reported Event|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
504617|NCT00745095|E2|Reported Event|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
504618|NCT00745095|E1|Reported Event|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (without NG)
504619|NCT00745030|B3|Baseline|Total|Total of all reporting groups
504620|NCT00745030|B2|Baseline|Placebo 8 mg Tablets|Placebo 8 mg tablets
504621|NCT00745030|B1|Baseline|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
504622|NCT00745030|P2|Participant Flow|Placebo 8 mg Tablets|Placebo 8 mg tablets
504623|NCT00745030|P1|Participant Flow|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
504624|NCT00745030|O2|Outcome|Placebo 8 mg Tablets|Placebo 8 mg tablets
504625|NCT00745030|O1|Outcome|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
504626|NCT00745030|E2|Reported Event|Placebo 8 mg Tablets|Placebo 8 mg tablets
504627|NCT00745030|E1|Reported Event|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
504628|NCT00744978|B3|Baseline|Total|Total of all reporting groups
504629|NCT00744978|B2|Baseline|Placebo Then Varenicline|Placebo twice a day (BID) initiated with a 2-week titration regimen (Week 1: once a day [QD]; Week 2: BID), followed by varenicline 1 mg BID initiated with a 2-week titration regimen (Week 1: 0.5 mg QD; Week 2: 0.5 mg BID).
504630|NCT00744978|B1|Baseline|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
504631|NCT00744978|P2|Participant Flow|Placebo Then Varenicline|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.
504632|NCT00744978|P1|Participant Flow|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
504633|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504634|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504635|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504636|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504637|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504638|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504639|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504640|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504641|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504642|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504643|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504644|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504645|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504646|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504647|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504648|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504649|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504650|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504651|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504652|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504653|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504654|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504655|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504656|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504657|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504658|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504659|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504660|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504661|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504662|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504663|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504664|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504665|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504666|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504667|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504668|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504669|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504670|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504671|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504672|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504673|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504674|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504675|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504676|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504677|NCT00744978|E2|Reported Event|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
504678|NCT00744978|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
504679|NCT00744939|B5|Baseline|Total|Total of all reporting groups
504680|NCT00744939|B4|Baseline|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504681|NCT00744939|B3|Baseline|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504682|NCT00744939|B2|Baseline|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
504683|NCT00744939|B1|Baseline|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504684|NCT00744939|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
504685|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
504686|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504687|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504688|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
504689|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504690|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
504691|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504692|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504693|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
504694|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504695|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
504696|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504697|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504698|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
504699|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504700|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
504701|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504702|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504703|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
504704|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504705|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
504706|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504707|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504708|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
504709|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504710|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
504711|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504712|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504713|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
504714|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504715|NCT00744939|E4|Reported Event|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
504716|NCT00744939|E3|Reported Event|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
504717|NCT00744939|E2|Reported Event|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
504718|NCT00744939|E1|Reported Event|Mild Renal Impairment|Participants with eGFR >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
504719|NCT00744874|B1|Baseline|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504720|NCT00744874|P1|Participant Flow|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504721|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504722|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504723|NCT00744874|O1|Outcome|Cumulative Radio Frequency Time for PV Isolation|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504724|NCT00744874|O3|Outcome|Quality of Life Scores at 6 Months|Quality of life scores at 6 months or 6 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504725|NCT00744874|O2|Outcome|Quality of Life Scores at 3 Months|Quality of life scores at 3 months or 3 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504726|NCT00744874|O1|Outcome|Baseline Quality of Life Scores|Quality of life scores at baseline or before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504727|NCT00744874|O3|Outcome|Ablated Patients Symptom Severity Score at 6 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
504728|NCT00744874|O2|Outcome|Ablated Patients Symptom Severity Score at 3 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.
504729|NCT00744874|O1|Outcome|Ablated Patients Symptom Severity Score at Baseline|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at baseline.
504730|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504731|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504732|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504733|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504734|NCT00744874|E1|Reported Event|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
504735|NCT00744848|B3|Baseline|Total|Total of all reporting groups
504736|NCT00744848|B2|Baseline|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
504737|NCT00744848|B1|Baseline|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
504738|NCT00744848|P2|Participant Flow|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
504739|NCT00744848|P1|Participant Flow|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
504740|NCT00744848|O2|Outcome|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
504741|NCT00744848|O1|Outcome|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
504742|NCT00744848|E2|Reported Event|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
504743|NCT00744848|E1|Reported Event|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
504744|NCT00744757|B1|Baseline|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504745|NCT00744757|P1|Participant Flow|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504746|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504747|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504748|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504749|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504750|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504751|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504752|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504753|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504754|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504755|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504756|NCT00744757|E1|Reported Event|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
504757|NCT00744692|B1|Baseline|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504758|NCT00744692|P1|Participant Flow|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504759|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504760|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504761|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504762|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504763|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504764|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504765|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504766|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504767|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504768|NCT00744692|E1|Reported Event|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
504769|NCT00744653|B1|Baseline|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
504770|NCT00744653|P1|Participant Flow|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
504771|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
504772|NCT00744653|O1|Outcome|Electrochemotherapy|All patients treated with electrochemotherapy
504773|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
504774|NCT00744653|E1|Reported Event|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
504775|NCT00744627|B3|Baseline|Total|Total of all reporting groups
504776|NCT00744627|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504777|NCT00744627|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504778|NCT00744627|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504779|NCT00744627|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504780|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504781|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504782|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504783|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504784|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504785|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504786|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504787|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504788|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504789|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504790|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
507611|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
504791|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504792|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504793|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504794|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504795|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504796|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504797|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504798|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504799|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504800|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504801|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504802|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504803|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504804|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504805|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504806|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504807|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504808|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504809|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504810|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504811|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504812|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504813|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504814|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504815|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504816|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504817|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504818|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504819|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504820|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504821|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504822|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504823|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504824|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504825|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504826|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504827|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504828|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504829|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504830|NCT00744627|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
504831|NCT00744627|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
504832|NCT00744523|B3|Baseline|Total|Total of all reporting groups
504833|NCT00744523|B2|Baseline|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504834|NCT00744523|B1|Baseline|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504835|NCT00744523|P2|Participant Flow|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504836|NCT00744523|P1|Participant Flow|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504837|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504933|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504838|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504839|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504840|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504841|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504842|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504843|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504844|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504845|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504846|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504847|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504848|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504849|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
504850|NCT00744523|O1|Outcome|MO.MA Training Cases (Roll-In)|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504851|NCT00744523|E2|Reported Event|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504852|NCT00744523|E1|Reported Event|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
504853|NCT00744497|B3|Baseline|Total|Total of all reporting groups
504854|NCT00744497|B2|Baseline|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504855|NCT00744497|B1|Baseline|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504856|NCT00744497|P2|Participant Flow|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504857|NCT00744497|P1|Participant Flow|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504858|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504859|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504860|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504861|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504862|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504863|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504864|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
505638|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
504865|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504866|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504867|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504868|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504869|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504870|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504871|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504872|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504873|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504874|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504875|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504876|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504877|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504878|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504879|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504880|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504881|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504882|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504883|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504884|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504885|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504886|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504887|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504888|NCT00744497|E2|Reported Event|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504889|NCT00744497|E1|Reported Event|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
504890|NCT00744380|B3|Baseline|Total|Total of all reporting groups
504891|NCT00744380|B2|Baseline|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504892|NCT00744380|B1|Baseline|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504934|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504893|NCT00744380|P2|Participant Flow|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504894|NCT00744380|P1|Participant Flow|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504895|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504896|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504897|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504898|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504899|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504900|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504901|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504902|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504903|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504904|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504905|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504935|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
507612|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
504906|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504907|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504908|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504909|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504910|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504911|NCT00744380|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504912|NCT00744380|E1|Reported Event|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
504913|NCT00744328|B4|Baseline|Total|Total of all reporting groups
504914|NCT00744328|B3|Baseline|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
504915|NCT00744328|B2|Baseline|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
504916|NCT00744328|B1|Baseline|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
504917|NCT00744328|P3|Participant Flow|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
504918|NCT00744328|P2|Participant Flow|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
504919|NCT00744328|P1|Participant Flow|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
504920|NCT00744328|O3|Outcome|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
504921|NCT00744328|O2|Outcome|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
504922|NCT00744328|O1|Outcome|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
504923|NCT00744328|E3|Reported Event|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
504924|NCT00744328|E2|Reported Event|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
504925|NCT00744328|E1|Reported Event|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
504926|NCT00744263|B3|Baseline|Total|Total of all reporting groups
504927|NCT00744263|B2|Baseline|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504928|NCT00744263|B1|Baseline|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504929|NCT00744263|P2|Participant Flow|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504930|NCT00744263|P1|Participant Flow|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504931|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504932|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
526173|NCT00699608|O1|Outcome|Placebo|Placebo
504936|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504937|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504938|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504939|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504940|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504941|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504942|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504943|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
504944|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
504945|NCT00744263|E4|Reported Event|Placebo Immunogenicity Subset|Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
504946|NCT00744263|E3|Reported Event|13vPnC Immunogenicity Subset|Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
504947|NCT00744263|E2|Reported Event|Placebo Safety Set|All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
504948|NCT00744263|E1|Reported Event|13vPnC Safety Set|All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
504949|NCT00744237|B4|Baseline|Total|Total of all reporting groups
504950|NCT00744237|B3|Baseline|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
504951|NCT00744237|B2|Baseline|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
504952|NCT00744237|B1|Baseline|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
504953|NCT00744237|P3|Participant Flow|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
504954|NCT00744237|P2|Participant Flow|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
504955|NCT00744237|P1|Participant Flow|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
504956|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
504957|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
504958|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
504959|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
504960|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
504961|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
504962|NCT00744237|E3|Reported Event|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
504963|NCT00744237|E2|Reported Event|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
504964|NCT00744237|E1|Reported Event|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
504965|NCT00744211|B4|Baseline|Total|Total of all reporting groups
504966|NCT00744211|B3|Baseline|ET-ARA 2mg/kg|2mg/kg sitaxsentan sodium
504967|NCT00744211|B2|Baseline|ET-ARA 1mg/kg|1mg/kg sitaxsentan sodium
504968|NCT00744211|B1|Baseline|Vehicle|Saline, intravenous bolus
504969|NCT00744211|P3|Participant Flow|ET-ARA 2mg/kg|2mg/kg sitaxsentan sodium intravenous bolus
504970|NCT00744211|P2|Participant Flow|ET-ARA 1mg/kg|1mg/kg sitaxsentan sodium intravenous bolus
504971|NCT00744211|P1|Participant Flow|Vehicle|Saline intravenous bolus
504972|NCT00744211|O3|Outcome|2mg/kg ET-ARA|2 mg/kg ET-ARA
504973|NCT00744211|O2|Outcome|1mg/kg ET-ARA|1 mg/kg ET-ARA
504974|NCT00744211|O1|Outcome|Vehicle|Vehicle group
504975|NCT00744211|O2|Outcome|2mg/kg ET-ARA|2 mg/kg ET-ARA
504976|NCT00744211|O1|Outcome|1mg/kg ET-ARA|1 mg/kg ET-ARA
504977|NCT00744211|O3|Outcome|2mg/kg ET-ARA|2 mg/kg ET-ARA
504978|NCT00744211|O2|Outcome|1mg/kg ET-ARA|1 mg/kg ET-ARA
504979|NCT00744211|O1|Outcome|Vehicle|Vehicle Group
504980|NCT00744211|O3|Outcome|2mg/kg ET-ARA|2 mg/kg ET-ARA
504981|NCT00744211|O2|Outcome|1mg/kg ET-ARA|1 mg/kg ET-ARA
504982|NCT00744211|O1|Outcome|Vehicle|Vehicle group
504983|NCT00744211|E3|Reported Event|ET-ARA 2mg/kg|ET - ARA 2 mg / kg
504984|NCT00744211|E2|Reported Event|ET-ARA 1mg/kg|ET - ARA 1 mg / kg
504985|NCT00744211|E1|Reported Event|Vehicle|Vehicle Group
504986|NCT00744055|B3|Baseline|Total|Total of all reporting groups
504987|NCT00744055|B2|Baseline|Placebo|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
504988|NCT00744055|B1|Baseline|Prazosin|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
504989|NCT00744055|P2|Participant Flow|Placebo|"Placebo in identical looking capsule blister packs~Placebo: Placebo"
504990|NCT00744055|P1|Participant Flow|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
504991|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
504992|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
504993|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
504994|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
504995|NCT00744055|E2|Reported Event|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
504996|NCT00744055|E1|Reported Event|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
504997|NCT00744042|B1|Baseline|Asfotase Alfa|All enrolled patients receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients begin thrice weekly SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for the remaining 23 weeks of the study.
504998|NCT00744042|P1|Participant Flow|Asfotase Alfa|All patients received an initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa for the first week followed by regular administration of subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times/week (total 3 mg/kg/week).
504999|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
505000|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
505001|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2mg/mg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
505002|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
505003|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
505004|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
505005|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
505006|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
505007|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
505639|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505008|NCT00744042|O1|Outcome|Asfotase Alfa|All HPP affected infants will receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients will then begin every other day SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for 23 weeks. End of Study will be at 24 weeks.
505009|NCT00744042|E1|Reported Event|Asfotase Alfa|All patients who received any asfotase alfa treatment, regardless of whether they were lost to follow-up or dropped out of the trial.
505010|NCT00743730|B4|Baseline|Total|Total of all reporting groups
505011|NCT00743730|B3|Baseline|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
505012|NCT00743730|B2|Baseline|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505013|NCT00743730|B1|Baseline|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505014|NCT00743730|P3|Participant Flow|Medication as Needed|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
505015|NCT00743730|P2|Participant Flow|PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505016|NCT00743730|P1|Participant Flow|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505017|NCT00743730|O3|Outcome|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
505018|NCT00743730|O2|Outcome|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505019|NCT00743730|O1|Outcome|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505020|NCT00743730|O3|Outcome|Intermittent Opioid on as Needed Basis|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
505021|NCT00743730|O2|Outcome|PNCA Without Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505022|NCT00743730|O1|Outcome|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505395|NCT00742560|O4|Outcome|Total (Phase 1)|Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505023|NCT00743730|E3|Reported Event|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
505024|NCT00743730|E2|Reported Event|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505025|NCT00743730|E1|Reported Event|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
505026|NCT00743717|B3|Baseline|Total|Total of all reporting groups
505027|NCT00743717|B2|Baseline|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
505028|NCT00743717|B1|Baseline|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
505029|NCT00743717|P2|Participant Flow|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
505030|NCT00743717|P1|Participant Flow|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
505031|NCT00743717|O2|Outcome|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
505032|NCT00743717|O1|Outcome|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
505033|NCT00743717|E2|Reported Event|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
505034|NCT00743717|E1|Reported Event|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
505035|NCT00743652|B6|Baseline|Total|Total of all reporting groups
505036|NCT00743652|B5|Baseline|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505037|NCT00743652|B4|Baseline|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505038|NCT00743652|B3|Baseline|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505039|NCT00743652|B2|Baseline|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505040|NCT00743652|B1|Baseline|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505041|NCT00743652|P5|Participant Flow|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505042|NCT00743652|P4|Participant Flow|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505043|NCT00743652|P3|Participant Flow|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505044|NCT00743652|P2|Participant Flow|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505045|NCT00743652|P1|Participant Flow|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505046|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505047|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505048|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505049|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505640|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505050|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505051|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505052|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505053|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505054|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505055|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505056|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505057|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505058|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505059|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505060|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505061|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505062|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505063|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505064|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505065|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505066|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505067|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505068|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505069|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505070|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505071|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505396|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505072|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505073|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505074|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505075|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505076|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505077|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505078|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505079|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505080|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505081|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505082|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505083|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505084|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505085|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505086|NCT00743652|O1|Outcome|13vPnC (All Participants)|All participants 6 weeks to <5 years of age who received at least one single IM 0.5 mL dose of 13vPnC in either the infant series or the toddler dose.
505087|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505088|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505089|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505090|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505091|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505092|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505093|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505094|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505095|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505096|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
507613|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
505097|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505098|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505099|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505100|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505101|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505102|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505103|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505104|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505105|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505106|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505107|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505108|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505109|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
505110|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
505111|NCT00743652|E8|Reported Event|Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
505112|NCT00743652|E7|Reported Event|Group 4 (2 Catch-Up Doses)|Participants ≥12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
505113|NCT00743652|E6|Reported Event|Group 3 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
505114|NCT00743652|E5|Reported Event|Group 2 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
505115|NCT00743652|E4|Reported Event|Group 1 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
505116|NCT00743652|E3|Reported Event|Group 3 (Infant Series)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series)
505117|NCT00743652|E2|Reported Event|Group 2 (Infant Series)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series)
505118|NCT00743652|E1|Reported Event|Group 1 (Infant Series)|Participants 6 weeks to <10 months of age with 0 prior doses of Prevnar received 3 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series).
505119|NCT00743574|B1|Baseline|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505120|NCT00743574|P1|Participant Flow|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505121|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505122|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505123|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505124|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505125|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505126|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505127|NCT00743574|E1|Reported Event|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
505128|NCT00743509|B1|Baseline|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505129|NCT00743509|P1|Participant Flow|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505130|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505131|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505132|NCT00743509|E1|Reported Event|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
505133|NCT00743483|B1|Baseline|BSSL|Bucelipase alfa (INN): oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
505134|NCT00743483|P1|Participant Flow|rhBSSL|Oral suspension, 170 mg rhBSSL, 3 times daily for 5-6 days
505135|NCT00743483|O1|Outcome|rhBSSL|oral suspension, 170 mg, 3 times daily for 5-6 days
505136|NCT00743483|E1|Reported Event|BSSL|Oral suspension, 170 mg, 3 times daily for 5-6 days
505137|NCT00743444|B1|Baseline|Entire Study Population|Includes groups randomized to received Drug first and Placebo first.
505138|NCT00743444|P2|Participant Flow|Placebo First, Then AZD3355|65 mg drug or placebo capsules, oral, 3 single doses
505139|NCT00743444|P1|Participant Flow|AZD3355 First, Then Placebo|65 mg drug or placebo capsules, oral, 3 single doses
505140|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
505141|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
505142|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
505143|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
505144|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
505145|NCT00743444|E2|Reported Event|Placebo|placebo capsules, oral, 3 single doses
505146|NCT00743444|E1|Reported Event|AZD3355|65 mg drug capsules, oral, 3 single doses
505147|NCT00743431|B1|Baseline|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
505148|NCT00743431|P1|Participant Flow|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
505149|NCT00743431|O1|Outcome|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
505150|NCT00743431|E1|Reported Event|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
505151|NCT00743366|B1|Baseline|Overall Number of Baseline Participants|
505152|NCT00743366|P2|Participant Flow|Placebo, Quetiapine (200mg/Day)|Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
507614|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
505153|NCT00743366|P1|Participant Flow|Quetiapine (200mg/Day), Placebo|Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
505154|NCT00743366|O2|Outcome|Placebo, Marijuana|
505155|NCT00743366|O1|Outcome|Quetiapine, Marijuana|"quetiapine's effects on marijuana withdrawal and relapse~Marijuana: 0,6.9% THC~Quetiapine: 0, 200 mg/day"
505156|NCT00743366|E2|Reported Event|Placebo, Quetiapine (200mg/Day)|Placebo medication (2x/day): Packaged riboflavin in size 00 opaque capsules to match size of active medication. Placebo capsules were administered 2 times per day (1100 and 2300 hours).
505157|NCT00743366|E1|Reported Event|Quetiapine (200mg/Day), Placebo|Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day (1100 and 2300 hours).
505158|NCT00743340|B1|Baseline|Emtricitabine|Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
505159|NCT00743340|P1|Participant Flow|Emtricitabine|Emtricitabine (FTC) 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
505160|NCT00743340|O1|Outcome|Emtricitabine|Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
505161|NCT00743340|E1|Reported Event|Emtricitabine|Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
505162|NCT00743288|B1|Baseline|Melphalan and Panobinostat (LBH589)|"Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
505163|NCT00743288|P7|Participant Flow|Melphalan and Panobinostat Schedule D3|20 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
505164|NCT00743288|P6|Participant Flow|Melphalan and Panobinostat Schedule D2|15 mg/daily of LBH589 PO and melphalan PO at 0.10 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
505165|NCT00743288|P5|Participant Flow|Melphalan and Panobinostat Schedule D1|15 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
505166|NCT00743288|P4|Participant Flow|Melphalan and Panobinostat Schedule C|20 mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
505167|NCT00743288|P3|Participant Flow|Melphalan and Panobinostat Schedule B2|20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
505168|NCT00743288|P2|Participant Flow|Melphalan and Panobinostat Schedule B1|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
505169|NCT00743288|P1|Participant Flow|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
505170|NCT00743288|O5|Outcome|Melphalan and Panobinostat All Patients|Data for all patients irrespective of dosage
505171|NCT00743288|O4|Outcome|Melphalan and Panobinostat Schedule D|"Schedules D1, D2 and D3~D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1"
505172|NCT00743288|O3|Outcome|Melphalan and Panobinostat Schedule C|0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
505173|NCT00743288|O2|Outcome|Melphalan and Panobinostat Schedule B|"Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.~B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1"
505174|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
505175|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
505176|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
505177|NCT00743288|O1|Outcome|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
505178|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule B|"B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.~B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1."
505219|NCT00743197|E2|Reported Event|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
505220|NCT00743197|E1|Reported Event|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
505179|NCT00743288|E1|Reported Event|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
505180|NCT00743275|B3|Baseline|Total|Total of all reporting groups
505181|NCT00743275|B2|Baseline|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
505182|NCT00743275|B1|Baseline|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
505183|NCT00743275|P2|Participant Flow|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
505184|NCT00743275|P1|Participant Flow|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
505185|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
505186|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
505187|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
505188|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
505189|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
505190|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
505191|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
505192|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
505193|NCT00743275|E2|Reported Event|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
505194|NCT00743275|E1|Reported Event|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
505195|NCT00743262|B1|Baseline|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
505196|NCT00743262|P1|Participant Flow|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
505197|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
505198|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
505199|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
505200|NCT00743262|E1|Reported Event|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
505201|NCT00743249|B3|Baseline|Total|Total of all reporting groups
505202|NCT00743249|B2|Baseline|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505203|NCT00743249|B1|Baseline|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505204|NCT00743249|P2|Participant Flow|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505205|NCT00743249|P1|Participant Flow|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505206|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505207|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505208|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505209|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505210|NCT00743249|E2|Reported Event|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505211|NCT00743249|E1|Reported Event|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
505212|NCT00743197|B3|Baseline|Total|Total of all reporting groups
505213|NCT00743197|B2|Baseline|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
505214|NCT00743197|B1|Baseline|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
505215|NCT00743197|P2|Participant Flow|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
505216|NCT00743197|P1|Participant Flow|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
505217|NCT00743197|O2|Outcome|Medical Treatment Group|
505218|NCT00743197|O1|Outcome|Usual Care Group|
505221|NCT00743119|B1|Baseline|Overall Number of Baseline Participants|34 participants were enrolled, but only 30 participants completed. Out of the additional 4 volunteers, 1 discontinued for personal reasons and three were unreliable.
505222|NCT00743119|P1|Participant Flow|Placebo/Dronabinol + Marijuana|During each session, one capsule containing placebo or dronabinol (10 mg or 20 mg) was administered to the participant 45 min before marijuana was smoked (0, 1.98, or 3.56% THC marijuana). Only one active dose of marijuana or dronabinol was administered within a session. A within-subject design was used in which all participants received all strengths of dronabinol and marijuana. The order was randomized.
505223|NCT00743119|O5|Outcome|Placebo + Inactive Marijuana 0% THC|Placebo + inactive marijuana (0% THC)
505224|NCT00743119|O4|Outcome|Placebo + High THC Marijuana|Placebo + high dose Marijuana (3.56% THC)
505225|NCT00743119|O3|Outcome|Placebo + Low THC Marijuana|Placebo + Marijuana (1.98% THC)
505226|NCT00743119|O2|Outcome|Low Dose Dronabinol + Inactive Marijuana|10mg Dronabinol + inactive Marijuana (0% THC)
505227|NCT00743119|O1|Outcome|High Dose Dronabinol + Inactive Marijuana|Dronabinol 20 mg + inactive marijuana (0%THC)
505228|NCT00743119|E5|Reported Event|Placebo + Marijuana (3.56% THC)|Adverse events recorded during Placebo + Marijuana (3.56% THC) treatment
505229|NCT00743119|E4|Reported Event|Placebo + Marijuana (1.98% THC)|Adverse events recorded during placebo + Marijuana (1.98% THC) treatment
505230|NCT00743119|E3|Reported Event|Dronabinol 20mg + Marijuana (0% THC)|Adverse events recorded during Dronabinol 20mg + Marijuana (0% THC) treatment
505231|NCT00743119|E2|Reported Event|Dronabinol 10 mg + Marijuana (0% THC)|Adverse events recorded during Dronabinol 10 mg + Marijuana (0% THC) treatment
505232|NCT00743119|E1|Reported Event|Placebo + Marijuana (0% THC)|Adverse events recorded during Placebo (PBO) + Marijuana (0% THC) treatment
505233|NCT00743106|B3|Baseline|Total|Total of all reporting groups
505234|NCT00743106|B2|Baseline|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
505235|NCT00743106|B1|Baseline|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
505236|NCT00743106|P2|Participant Flow|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
505237|NCT00743106|P1|Participant Flow|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
505238|NCT00743106|O2|Outcome|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
505239|NCT00743106|O1|Outcome|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
505240|NCT00743106|O2|Outcome|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
505241|NCT00743106|O1|Outcome|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
505242|NCT00743106|E2|Reported Event|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
505243|NCT00743106|E1|Reported Event|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
505244|NCT00743093|B3|Baseline|Total|Total of all reporting groups
505245|NCT00743093|B2|Baseline|Placebo Arm|placebo
505246|NCT00743093|B1|Baseline|Acetaminophen Arm|acetaminophen 500 mg
505247|NCT00743093|P2|Participant Flow|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
505248|NCT00743093|P1|Participant Flow|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
505249|NCT00743093|O2|Outcome|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
505250|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
505251|NCT00743093|O2|Outcome|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
505252|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
505253|NCT00743093|E2|Reported Event|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
505254|NCT00743093|E1|Reported Event|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
505255|NCT00742963|B1|Baseline|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
505256|NCT00742963|P1|Participant Flow|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
505257|NCT00742963|O1|Outcome|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
505258|NCT00742963|E1|Reported Event|TH-302 in Combination With Doxorubicin|"75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.~TH-302: TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Dose escalation dose levels:~Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2"
505259|NCT00742924|B5|Baseline|Total|Total of all reporting groups
505260|NCT00742924|B4|Baseline|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505261|NCT00742924|B3|Baseline|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505262|NCT00742924|B2|Baseline|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505263|NCT00742924|B1|Baseline|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505264|NCT00742924|P4|Participant Flow|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505265|NCT00742924|P3|Participant Flow|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505266|NCT00742924|P2|Participant Flow|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505267|NCT00742924|P1|Participant Flow|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505268|NCT00742924|O4|Outcome|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505269|NCT00742924|O3|Outcome|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505270|NCT00742924|O2|Outcome|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505271|NCT00742924|O1|Outcome|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505272|NCT00742924|E4|Reported Event|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505273|NCT00742924|E3|Reported Event|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505295|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group.|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505912|NCT00741273|O4|Outcome|Proellex 50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
505274|NCT00742924|E2|Reported Event|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505275|NCT00742924|E1|Reported Event|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
505276|NCT00742885|B3|Baseline|Total|Total of all reporting groups
505277|NCT00742885|B2|Baseline|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505278|NCT00742885|B1|Baseline|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505279|NCT00742885|P2|Participant Flow|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505280|NCT00742885|P1|Participant Flow|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505281|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505282|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505283|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505284|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505285|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm
505286|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505287|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505288|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505289|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505290|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505291|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505292|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505293|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505294|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505913|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
505296|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group.|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505297|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505298|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505299|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505300|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505301|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505302|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505303|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505304|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505305|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505306|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505307|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505308|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505309|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505310|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505311|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505312|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505313|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505314|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505315|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505316|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505317|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505318|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505319|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505320|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505393|NCT00742560|O6|Outcome|Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505321|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505322|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505323|NCT00742885|E2|Reported Event|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505324|NCT00742885|E1|Reported Event|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
505325|NCT00742872|B3|Baseline|Total|Total of all reporting groups
505326|NCT00742872|B2|Baseline|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
505327|NCT00742872|B1|Baseline|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
505328|NCT00742872|P2|Participant Flow|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
505329|NCT00742872|P1|Participant Flow|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
505330|NCT00742872|O2|Outcome|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
505331|NCT00742872|O1|Outcome|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
505332|NCT00742872|E2|Reported Event|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
505333|NCT00742872|E1|Reported Event|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
505334|NCT00742859|B5|Baseline|Total|Total of all reporting groups
505335|NCT00742859|B4|Baseline|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
505336|NCT00742859|B3|Baseline|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
505337|NCT00742859|B2|Baseline|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
505338|NCT00742859|B1|Baseline|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
505339|NCT00742859|P4|Participant Flow|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
505340|NCT00742859|P3|Participant Flow|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
505341|NCT00742859|P2|Participant Flow|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
505342|NCT00742859|P1|Participant Flow|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
505343|NCT00742859|O4|Outcome|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
505344|NCT00742859|O3|Outcome|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
505345|NCT00742859|O2|Outcome|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
505346|NCT00742859|O1|Outcome|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
505347|NCT00742859|O4|Outcome|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
505348|NCT00742859|O3|Outcome|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
505349|NCT00742859|O2|Outcome|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
505350|NCT00742859|O1|Outcome|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
505351|NCT00742859|E4|Reported Event|Warfarin|Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
505352|NCT00742859|E3|Reported Event|Betrixaban 80 mg|Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
505353|NCT00742859|E2|Reported Event|Betrixaban 60 mg|Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
505354|NCT00742859|E1|Reported Event|Betrixaban 40 mg|Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
505355|NCT00742781|B1|Baseline|Vitamin D Supplementation|
505356|NCT00742781|P1|Participant Flow|Vitamin D Supplementation|
505357|NCT00742781|O2|Outcome|Vitamin D Supplemented|
505358|NCT00742781|O1|Outcome|Baseline|
505359|NCT00742781|O2|Outcome|Vitamin D Supplemented|
505360|NCT00742781|O1|Outcome|Baseline|
505361|NCT00742781|O2|Outcome|Vitamin D Supplemented|
505362|NCT00742781|O1|Outcome|Baseline|
505363|NCT00742781|E1|Reported Event|Vitamin D Supplemented|
505394|NCT00742560|O5|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
507615|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
505364|NCT00742625|B1|Baseline|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
505365|NCT00742625|P1|Participant Flow|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
505366|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
505367|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
505368|NCT00742625|O3|Outcome|Bortezomib (1.3 mg/m^2) + Int-DAC|Bortezomib (1.3 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
505369|NCT00742625|O2|Outcome|Bortezomib (1.0 mg/m^2) + Int-DAC|Bortezomib (1.0 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
505370|NCT00742625|O1|Outcome|Bortezomib (0.7 mg/m^2) + Int-DAC|Bortezomib (0.7 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
505371|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
505372|NCT00742625|E1|Reported Event|Bortezomib + Daunorubicin + Cytarabine|Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
505373|NCT00742560|B6|Baseline|Total|Total of all reporting groups
505374|NCT00742560|B5|Baseline|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505375|NCT00742560|B4|Baseline|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505376|NCT00742560|B3|Baseline|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505377|NCT00742560|B2|Baseline|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505378|NCT00742560|B1|Baseline|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505379|NCT00742560|P5|Participant Flow|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505380|NCT00742560|P4|Participant Flow|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505381|NCT00742560|P3|Participant Flow|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505382|NCT00742560|P2|Participant Flow|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505383|NCT00742560|P1|Participant Flow|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505384|NCT00742560|O5|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505385|NCT00742560|O4|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505386|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505387|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505388|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505389|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505390|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505391|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505392|NCT00742560|O7|Outcome|Total (Phase 2)|Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505397|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505398|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505399|NCT00742560|O7|Outcome|Total (Phase 2)|Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505400|NCT00742560|O6|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505401|NCT00742560|O5|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505402|NCT00742560|O4|Outcome|Total (Phase 1)|Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505403|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505404|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505405|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505406|NCT00742560|O7|Outcome|Total (Phase 2)|Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
505407|NCT00742560|O6|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505408|NCT00742560|O5|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505409|NCT00742560|O4|Outcome|Total (Phase 1)|Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505410|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505411|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505412|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505413|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505414|NCT00742560|O2|Outcome|Elotuzumab 5 mg/kg Administered as an IV Infusion in Combinati|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505415|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
505416|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505417|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505418|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
505419|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505420|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505421|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
505422|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505423|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505424|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
505425|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505426|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505427|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
505428|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505429|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.
505430|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1.
505431|NCT00742560|O5|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505432|NCT00742560|O4|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505433|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505434|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505435|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505436|NCT00742560|O5|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505437|NCT00742560|O4|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505438|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505439|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505440|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505441|NCT00742560|O4|Outcome|Total (Phase 1)|Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505442|NCT00742560|O3|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
505443|NCT00742560|O2|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505444|NCT00742560|O1|Outcome|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505445|NCT00742560|O3|Outcome|Total (Phase 2)|Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505446|NCT00742560|O2|Outcome|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505447|NCT00742560|O1|Outcome|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
505448|NCT00742560|O1|Outcome|Phase 1 Elotuzumab + Lenalidomide and Dexamethasone|Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505449|NCT00742560|E5|Reported Event|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505450|NCT00742560|E4|Reported Event|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505451|NCT00742560|E3|Reported Event|Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505452|NCT00742560|E2|Reported Event|Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505453|NCT00742560|E1|Reported Event|Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)|Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
505454|NCT00742508|B3|Baseline|Total|Total of all reporting groups
505455|NCT00742508|B2|Baseline|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505641|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505456|NCT00742508|B1|Baseline|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505457|NCT00742508|P2|Participant Flow|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505458|NCT00742508|P1|Participant Flow|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505459|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505460|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505461|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505462|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505463|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505525|NCT00742417|O1|Outcome|Albutein 5%|"Patients allocated to this arm will undergo plasma exchange with Albutein 5%.~Albutein 5%: 18 Plasma Exchanges using~Albutein 5% or~Sham Procedure~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505526|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
505464|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505465|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505466|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505467|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505468|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505469|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505470|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505471|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505527|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505528|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
526174|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
505472|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505473|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505474|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505475|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505476|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505477|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505478|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505479|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505529|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505530|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
526175|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
505480|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505481|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505482|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505483|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505484|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505485|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505486|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505487|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505531|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505532|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
505739|NCT00742079|O1|Outcome|D-cycloserine|Participants receive 50 mg of D-cycloserine
505488|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505489|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505490|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505491|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505492|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505493|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505494|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505495|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505533|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505534|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
507616|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
505496|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505497|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505498|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505499|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505500|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505501|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505502|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505503|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505535|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505536|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
507617|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
505504|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505505|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505506|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505507|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505508|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505509|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505510|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505511|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505537|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505538|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
526176|NCT00699608|O1|Outcome|Placebo|Placebo
505512|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505513|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505514|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505515|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505516|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505517|NCT00742508|E2|Reported Event|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
505518|NCT00742508|E1|Reported Event|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
505519|NCT00742417|B3|Baseline|Total|Total of all reporting groups
505520|NCT00742417|B2|Baseline|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
505521|NCT00742417|B1|Baseline|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505522|NCT00742417|P2|Participant Flow|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
505523|NCT00742417|P1|Participant Flow|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505524|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
505637|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505539|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505540|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
505541|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505542|NCT00742417|E2|Reported Event|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
505543|NCT00742417|E1|Reported Event|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
505544|NCT00742391|B3|Baseline|Total|Total of all reporting groups
505545|NCT00742391|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
505546|NCT00742391|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
505547|NCT00742391|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
505548|NCT00742391|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
505549|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
505550|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
505551|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
505552|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
505553|NCT00742391|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
505554|NCT00742391|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
505555|NCT00742326|B3|Baseline|Total|Total of all reporting groups
505556|NCT00742326|B2|Baseline|Placebo|Placebo once daily for 48 weeks
505557|NCT00742326|B1|Baseline|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
505558|NCT00742326|P2|Participant Flow|Placebo|Placebo once daily for 48 weeks
505559|NCT00742326|P1|Participant Flow|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
505560|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
505561|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
505562|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
505563|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
505564|NCT00742326|E2|Reported Event|Placebo|Placebo once daily for 48 weeks
505565|NCT00742326|E1|Reported Event|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
505566|NCT00742313|B3|Baseline|Total|Total of all reporting groups
505567|NCT00742313|B2|Baseline|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
505568|NCT00742313|B1|Baseline|FloSeal|Arm A has FloSeal Matrix applied to EVH wound bed.
505569|NCT00742313|P2|Participant Flow|Non-FloSeal Matrix|FloSeal Matrix was not added to the wound bed
505570|NCT00742313|P1|Participant Flow|FloSeal Matrix|FloSeal Matrix applied to EVH wound bed.
505571|NCT00742313|O2|Outcome|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
505572|NCT00742313|O1|Outcome|FloSeal Matrix|Arm A has FloSeal Matrix applied to EVH wound bed.
505573|NCT00742313|E2|Reported Event|Arm B|Arm B does not have FloSeal Matrix applied to EVH wound bed.
505574|NCT00742313|E1|Reported Event|Arm A|Arm A has FloSeal Matrix applied to EVH wound bed.
505575|NCT00742274|B3|Baseline|Total|Total of all reporting groups
505576|NCT00742274|B2|Baseline|BEST MEDICAL THERAPY (BMT) Alone|
505577|NCT00742274|B1|Baseline|TAG Device + Best Medical Therapy (BMT)|
505578|NCT00742274|P2|Participant Flow|Best Medical Therapy (BMT) Alone|BMT alone
505579|NCT00742274|P1|Participant Flow|TAG Device + Best Medical Therapy (BMT)|TAG+BMT
505580|NCT00742274|O2|Outcome|BEST MEDICAL THERAPY (BMT) Alone|
505581|NCT00742274|O1|Outcome|TAG Device + Best Medical Therapy (BMT)|
505582|NCT00742274|E2|Reported Event|BEST MEDICAL THERAPY (BMT) Alone|
505583|NCT00742274|E1|Reported Event|TAG Device + Best Medical Therapy (BMT)|
505584|NCT00742235|B3|Baseline|Total|Total of all reporting groups
505585|NCT00742235|B2|Baseline|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
505586|NCT00742235|B1|Baseline|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
505587|NCT00742235|P2|Participant Flow|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL who were offered ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total)
505588|NCT00742235|P1|Participant Flow|Vitamin D Sufficient|Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml.
505589|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
505590|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
505591|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
505592|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
505593|NCT00742235|E2|Reported Event|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
505594|NCT00742235|E1|Reported Event|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
505595|NCT00742209|B6|Baseline|Total|Total of all reporting groups
505596|NCT00742209|B5|Baseline|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
505597|NCT00742209|B4|Baseline|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day.
505598|NCT00742209|B3|Baseline|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day.
505599|NCT00742209|B2|Baseline|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
505600|NCT00742209|B1|Baseline|Placebo|Oral GEn (XP13512) placebo on Weeks 1-17
505601|NCT00742209|P5|Participant Flow|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
505602|NCT00742209|P4|Participant Flow|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505603|NCT00742209|P3|Participant Flow|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505604|NCT00742209|P2|Participant Flow|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
505605|NCT00742209|P1|Participant Flow|Placebo|Oral GEn (XP13512) placebo
505606|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505607|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505608|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505609|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505610|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505611|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505612|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505613|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505614|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505615|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505616|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505617|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505618|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505619|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505620|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505621|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505622|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505623|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505624|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505625|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505626|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505627|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505628|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505629|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505630|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505631|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505632|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505633|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505634|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505635|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505636|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
507618|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
505642|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505643|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505644|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505645|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505646|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505647|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505648|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505649|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505650|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505651|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505652|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505653|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505654|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505655|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505656|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505657|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505658|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505659|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505660|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505661|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505662|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505663|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505664|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505665|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505666|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505667|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505668|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505669|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505670|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505671|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505672|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505673|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505674|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505675|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505676|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505677|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505678|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505679|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505680|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505681|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505682|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505683|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505684|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505685|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505686|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
507619|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
505687|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505688|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505689|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505690|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505691|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505692|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505693|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505694|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505695|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505696|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505697|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505698|NCT00742209|O2|Outcome|Average of GEn 1800/2400 mg|Average of GEn 1800 mg group and GEn 2400 mg group
505699|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
505700|NCT00742209|E5|Reported Event|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
505701|NCT00742209|E4|Reported Event|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
505702|NCT00742209|E3|Reported Event|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
505703|NCT00742209|E2|Reported Event|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
505704|NCT00742209|E1|Reported Event|Placebo|Oral GEn (XP13512) placebo
505705|NCT00742183|B3|Baseline|Total|Total of all reporting groups
505706|NCT00742183|B2|Baseline|Silvadene® Cream 1%|Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second-and third-degree burns.
505707|NCT00742183|B1|Baseline|Mepilex® Ag|The dressing to be used Mepilex® Ag, consists of an absorbent polyurethane foam pad containing silver sulphate with a silicone contact layer with the Safetac® technology. The silver ions are hydro activated in presence of fluid or wound exudates.
505708|NCT00742183|P2|Participant Flow|Silvadene|Silver sulfadiazine 1% cream treatment period will be a maximum of three weeks. Dressing changes of Silvadene® will be performed at least once per day.
505709|NCT00742183|P1|Participant Flow|Mepilex Ag|"Treatment period will be a maximum of three weeks with Silvadene® or Mepilex® Ag.~Dressing changes of Mepilex® Ag will be performed every 5-7 day, depending on the status of the burn"
505710|NCT00742183|O2|Outcome|Silvadene|Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated).
505711|NCT00742183|O1|Outcome|Mepilex Ag|Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated).
505712|NCT00742183|E2|Reported Event|Silvadene|Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug.
505713|NCT00742183|E1|Reported Event|Mepilex Ag|Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment.
505714|NCT00742170|B3|Baseline|Total|Total of all reporting groups
505715|NCT00742170|B2|Baseline|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505716|NCT00742170|B1|Baseline|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505717|NCT00742170|P2|Participant Flow|Sham Electroacupuncture Condition|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505812|NCT00741611|P3|Participant Flow|Roll-ins|Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.
505718|NCT00742170|P1|Participant Flow|Active Electroacupuncture Condition|"Active electroacupuncture condition~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505719|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505720|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505721|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505722|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505723|NCT00742170|E2|Reported Event|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505724|NCT00742170|E1|Reported Event|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
505725|NCT00742079|B3|Baseline|Total|Total of all reporting groups
505726|NCT00742079|B2|Baseline|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
505727|NCT00742079|B1|Baseline|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
505728|NCT00742079|P2|Participant Flow|2 Placebo First, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
505729|NCT00742079|P1|Participant Flow|1 D-cycloserine First, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
505730|NCT00742079|O2|Outcome|Placebo|Participants receive 50 mg of placebo
505731|NCT00742079|O1|Outcome|D-cycloserine|Participants receive 50 mg of D-cycloserine
505732|NCT00742079|O2|Outcome|Placebo|Participants receive 50 mg of placebo
505733|NCT00742079|O1|Outcome|D-cycloserine|Participants receive 50 mg of D-cycloserine
505734|NCT00742079|O2|Outcome|Placebo|Participants receive 50 mg of placebo
505735|NCT00742079|O1|Outcome|D-cycloserine|Participants receive 50 mg of D-cycloserine
505736|NCT00742079|O2|Outcome|Placebo|Participants receive 50 mg of placebo
505737|NCT00742079|O1|Outcome|D-cycloserine|Participants receive 50 mg of D-cycloserine
505738|NCT00742079|O2|Outcome|Placebo|Participants receive 50 mg of placebo
505740|NCT00742079|E2|Reported Event|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
505741|NCT00742079|E1|Reported Event|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
505742|NCT00742053|B1|Baseline|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
505743|NCT00742053|P1|Participant Flow|PICC Insertion|All patients, aged 18 to 80 years, who required Peripherally inserted central catheter (PICC) insertion for their standard care will be studied.
505744|NCT00742053|O1|Outcome|PICC Placement|Patients who require PICC placement
505745|NCT00742053|E1|Reported Event|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
505746|NCT00741988|B3|Baseline|Total|Total of all reporting groups
505747|NCT00741988|B2|Baseline|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
505748|NCT00741988|B1|Baseline|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
505749|NCT00741988|P2|Participant Flow|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
505750|NCT00741988|P1|Participant Flow|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
505751|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
505752|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
505753|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
505754|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
505755|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
505756|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
505757|NCT00741988|E2|Reported Event|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
505758|NCT00741988|E1|Reported Event|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
505759|NCT00741936|B3|Baseline|Total|Total of all reporting groups
505760|NCT00741936|B2|Baseline|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505761|NCT00741936|B1|Baseline|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505762|NCT00741936|P2|Participant Flow|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505763|NCT00741936|P1|Participant Flow|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505764|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505765|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505766|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505767|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505768|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505769|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505770|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505771|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505772|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505773|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505774|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505775|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505776|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
506072|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
505777|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505778|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505779|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505780|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505781|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505782|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505783|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505784|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505785|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505786|NCT00741936|E2|Reported Event|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505787|NCT00741936|E1|Reported Event|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
505788|NCT00741858|B3|Baseline|Total|Total of all reporting groups
505789|NCT00741858|B2|Baseline|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
505790|NCT00741858|B1|Baseline|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
505791|NCT00741858|P2|Participant Flow|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
505792|NCT00741858|P1|Participant Flow|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
505793|NCT00741858|O2|Outcome|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
505794|NCT00741858|O1|Outcome|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
505795|NCT00741858|E2|Reported Event|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
505796|NCT00741858|E1|Reported Event|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
505797|NCT00741819|B1|Baseline|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
505798|NCT00741819|P1|Participant Flow|Inhaled Treprostinil|Inhaled treprostinil was given four times daily at doses titrated up to 12 breaths.
505799|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
505800|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
505801|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
505802|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
505803|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
505804|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
505805|NCT00741819|O1|Outcome|Inhaled Treprostinil|Up to 12 breaths four times daily.
505806|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily
505807|NCT00741819|E1|Reported Event|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
505808|NCT00741611|B4|Baseline|Total|Total of all reporting groups
505809|NCT00741611|B3|Baseline|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
505810|NCT00741611|B2|Baseline|Drug|Treatment with anti-arrhythmic drugs
505811|NCT00741611|B1|Baseline|Mesh|Ablation with HD Mesh Ablation System
506132|NCT00740779|B4|Baseline|Total|Total of all reporting groups
505813|NCT00741611|P2|Participant Flow|Drug|Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
505814|NCT00741611|P1|Participant Flow|Mesh|Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
505815|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
505816|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
505817|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
505818|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
505819|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
505820|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
505821|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
505822|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
505823|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
505824|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
505825|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
505826|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
505827|NCT00741611|E3|Reported Event|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
505828|NCT00741611|E2|Reported Event|Drug|Treatment with anti-arrhythmic drugs
505829|NCT00741611|E1|Reported Event|Mesh|Ablation with HD Mesh Ablation System
505830|NCT00741598|B3|Baseline|Total|Total of all reporting groups
505831|NCT00741598|B2|Baseline|Placebo|placebo equivalent
505832|NCT00741598|B1|Baseline|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505833|NCT00741598|P2|Participant Flow|Placebo|placebo equivalent
505834|NCT00741598|P1|Participant Flow|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505835|NCT00741598|O2|Outcome|Placebo|placebo equivalent
505836|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505837|NCT00741598|O2|Outcome|Placebo|placebo equivalent
505838|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505839|NCT00741598|O2|Outcome|Placebo|placebo equivalent
505840|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505841|NCT00741598|O2|Outcome|Placebo|placebo equivalent
505842|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505843|NCT00741598|O2|Outcome|Placebo|16-week treatment with flexible doses of placebo equivalent
505844|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505845|NCT00741598|E2|Reported Event|Placebo|placebo equivalent
505846|NCT00741598|E1|Reported Event|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
505847|NCT00741468|B1|Baseline|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
505848|NCT00741468|P1|Participant Flow|All Participants|CYP1A2, Day 8 relative to Day 1 AUC (caffeine probe) CYP2C19, Day 8 relative to Day 1 AUC (omeprazole probe) CYP 2C9, Day 8 relative to Day 1 AUC (tolbutamide probe) CYP2D6, Day 8 relative to Day 1 AUC (dextromethorphan probe) CYP3A4, Day 8 relative to Day 1 AUC (midazolam probe)
505849|NCT00741468|O5|Outcome|CYP3A4|Day 8 relative to Day 1 AUC (midazolam probe)
505850|NCT00741468|O4|Outcome|CYP2D6|Day 8 relative to Day 1 AUC (dextromethorphan probe)
505851|NCT00741468|O3|Outcome|CYP2C19|Day 8 relative to Day 1 AUC (omeprazole probe)
505852|NCT00741468|O2|Outcome|CYP2C9|Day 8 relative to Day 1 AUC (tolbutamide probe)
505853|NCT00741468|O1|Outcome|CYP1A2|Day 8 relative to Day 1 AUC (caffeine probe)
505854|NCT00741468|E1|Reported Event|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
505855|NCT00741390|B1|Baseline|Entire Study Population|
505856|NCT00741390|P4|Participant Flow|Arm D|Visit1 (V1): BD/33G,OTM/33G,OTM/28G; V2: OTM/33G, OTM/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm D are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the OTM/33G and OTM/28G were used.
505857|NCT00741390|P3|Participant Flow|Arm C|Visit 1 (V1): BD/33G, OTM/33G,ACC/28G Visit 2 (V2): BD/33G, ACC/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm C are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: ACC/28G (Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip). For Visit 2 only the BD/33G and ACC/28G were used.
505906|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
505907|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
505908|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
505858|NCT00741390|P2|Participant Flow|Arm B|Visit 1 (V1):BD/33G,OTM/33G,OTU/28G; Visit 2 (V2):BD/33G, OTU/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing).The lancet/lancing device combinations assigned to Arm B are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTU/28G (OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the BD/33G and OTU/28G were used.
505859|NCT00741390|P1|Participant Flow|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm A are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips. For Visit 2 only the BD/33G and OTM/28G were used.
505860|NCT00741390|O4|Outcome|OTM/28G - OTM/33G|OneTouch MiniDevice / OneTouch 28g Lancet - OneTouch MiniDevice /BD 33 Gauge Lancet
505861|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
505862|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
505863|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
505864|NCT00741390|O1|Outcome|OTM/28G - OTM/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to OneTouch Mini Device / BD 33G Lancet
505865|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device/Accu-Chek Softclix 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
505866|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
505867|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
505868|NCT00741390|O5|Outcome|ACC/28G|"Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet~See description for BD/33G."
505869|NCT00741390|O4|Outcome|OTU/28G|"OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
505870|NCT00741390|O3|Outcome|OTM/28G|"OneTouch Mini Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
505871|NCT00741390|O2|Outcome|OTM/33G|"OneTouch Mini Device / BD 33 Gauge Lancet~See description for BD/33G."
505872|NCT00741390|O1|Outcome|BD/33G|"BD Lancet Device / BD 33 Gauge Lancet.~In Study Visit 1 each subject was randomly assigned to one of four groups, each subject evaluated three different lancet device/lancet combinations. The order of evaluation of the three systems was randomly assigned for each subject. Subjects started at the middle depth setting of each lancet device. The lowest depth setting for each system yielding sufficient volume for each system was recorded for that subject and used during Visit 2. All subjects whom obtained adequate sample volumes were selected to participate in Study Visit 2."
505873|NCT00741390|E4|Reported Event|Arm D|Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G
505874|NCT00741390|E3|Reported Event|Arm C|Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G
505875|NCT00741390|E2|Reported Event|Arm B|Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G
505876|NCT00741390|E1|Reported Event|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G
505877|NCT00741338|B3|Baseline|Total|Total of all reporting groups
505878|NCT00741338|B2|Baseline|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
505879|NCT00741338|B1|Baseline|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
505880|NCT00741338|P2|Participant Flow|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
505909|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
505910|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
505911|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
505881|NCT00741338|P1|Participant Flow|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
505882|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
505883|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
505884|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
505885|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
505886|NCT00741338|E2|Reported Event|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low- dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
505887|NCT00741338|E1|Reported Event|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
505888|NCT00741286|B3|Baseline|Total|Total of all reporting groups
505889|NCT00741286|B2|Baseline|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
505890|NCT00741286|B1|Baseline|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
505891|NCT00741286|P2|Participant Flow|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
505892|NCT00741286|P1|Participant Flow|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
505893|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
505894|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
505895|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
505896|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
505897|NCT00741286|E2|Reported Event|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
505898|NCT00741286|E1|Reported Event|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
505899|NCT00741273|B3|Baseline|Total|Total of all reporting groups
505900|NCT00741273|B2|Baseline|Mpaired|Hepatically impaired females
505901|NCT00741273|B1|Baseline|Healthy|Healthy females
505902|NCT00741273|P2|Participant Flow|Impaired|Proellex single dose each of 25 mg and 50 mg in hepatically impaired females
505903|NCT00741273|P1|Participant Flow|Healthy|Proellex single dose each of 25 mg and 50 mg in healthy females
505904|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
505905|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
506133|NCT00740779|B3|Baseline|Placebo|1 placebo capsule daily
505914|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 50 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
505915|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
505916|NCT00741273|E2|Reported Event|Proellex Impaired|"Proellex 25 mg and 50 mg in hepatically impaired females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
505917|NCT00741273|E1|Reported Event|Proellex Healthy|"Proellex 25 mg and 50 mg in healthy females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
505918|NCT00741260|B8|Baseline|Total|Total of all reporting groups
505919|NCT00741260|B7|Baseline|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
505920|NCT00741260|B6|Baseline|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
505921|NCT00741260|B5|Baseline|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/sq m
505922|NCT00741260|B4|Baseline|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/sq m
505923|NCT00741260|B3|Baseline|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/sq m
505924|NCT00741260|B2|Baseline|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/sq m
505925|NCT00741260|B1|Baseline|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/sq m
505926|NCT00741260|P7|Participant Flow|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
505927|NCT00741260|P6|Participant Flow|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
505928|NCT00741260|P5|Participant Flow|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/sq m
505929|NCT00741260|P4|Participant Flow|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/sq m
505930|NCT00741260|P3|Participant Flow|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/sq m
505931|NCT00741260|P2|Participant Flow|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/sq m
505932|NCT00741260|P1|Participant Flow|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/sq m
505933|NCT00741260|O3|Outcome|Lapatinib Naive Subjects Part 2 + Part 1|MTD (Part 2 + Part 1), Subjects without Prior Lapatinib Experience
505934|NCT00741260|O2|Outcome|Lapatinib Naive Subjects P1|MTD (Part 2), Subjects without Prior Lapatinib Experience
505935|NCT00741260|O1|Outcome|Prior Lapatinib Subjects|MTD (Part 2), Subjects with Prior Lapatinib Experience
505936|NCT00741260|O3|Outcome|Lapatinib Naive Subjects Part 2 + Part 1|MTD (Part 2 + Part 1), Subjects without Prior Lapatinib Experience
505937|NCT00741260|O2|Outcome|Lapatinib Naive Subjects P1|MTD (Part 2), Subjects without Prior Lapatinib Experience
505938|NCT00741260|O1|Outcome|Prior Lapatinib Subjects|MTD (Part 2), Subjects with Prior Lapatinib Experience
505939|NCT00741260|O3|Outcome|Lapatinib Naive Subjects Part 2 + Part 1|MTD (Part 2 + Part 1), Subjects without Prior Lapatinib Experience
505940|NCT00741260|O2|Outcome|Lapatinib Naive Subjects P1|MTD (Part 2), Subjects without Prior Lapatinib Experience
505941|NCT00741260|O1|Outcome|Prior Lapatinib Subjects|MTD (Part 2), Subjects with Prior Lapatinib Experience
505942|NCT00741260|O7|Outcome|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
505943|NCT00741260|O6|Outcome|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
505944|NCT00741260|O5|Outcome|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/m2
505945|NCT00741260|O4|Outcome|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/m2
505946|NCT00741260|O3|Outcome|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/m2
505947|NCT00741260|O2|Outcome|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/m2
505948|NCT00741260|O1|Outcome|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/m2
505949|NCT00741260|E7|Reported Event|N + C MTD - Prior Lap|Neratinib + Capecitabine MTD (Prior Lapatinib)
505950|NCT00741260|E6|Reported Event|N + C MTD - No Prior Lap|Neratinib + Capecitabine MTD (No prior Lapatinib)
505951|NCT00741260|E5|Reported Event|N160 + C2000|Neratinib 160 mg + Capecitabine 2000 mg/m2
505952|NCT00741260|E4|Reported Event|N200 + C2000|Neratinib 200 mg + Capecitabine 2000 mg/m2
505953|NCT00741260|E3|Reported Event|N240 + C2000|Neratinib 240 mg + Capecitabine 2000 mg/m2
505954|NCT00741260|E2|Reported Event|N240 + C1500|Neratinib 240 mg + Capecitabine 1500 mg/m2
505955|NCT00741260|E1|Reported Event|N160 + C1500|Neratinib 160 mg + Capecitabine 1500 mg/m2
505956|NCT00741156|B1|Baseline|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
505957|NCT00741156|P1|Participant Flow|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
505958|NCT00741156|O6|Outcome|Cerebral Resistance After Enalaprilat|cerebral resistance is measured after enalaprilat
505959|NCT00741156|O5|Outcome|Cerebral Resistance at Baseline|cerebral resistance is measured in baseline condition
505960|NCT00741156|O4|Outcome|Pulmonary Resistance After Enalaprilat|pulmonary resistance is measured after enalaprilat
505961|NCT00741156|O3|Outcome|Pulmonary Resistance at Baseline|pulmonary resistance at baseline is measured
505962|NCT00741156|O2|Outcome|Systemic Resistance After Enalaprilat|systemic resistance is measured after enalaprilat
505963|NCT00741156|O1|Outcome|Systemic Resistance at Baseline|systemic resistance in baseline condition
505964|NCT00741156|O6|Outcome|Cerebral Blood Flow After Enalaprilat|Cerebral blood flow 20 minutes after enalaprilat
505965|NCT00741156|O5|Outcome|Cerebral Blood Flow Baseline|Cerebral blood flow at baseline
505966|NCT00741156|O4|Outcome|Pulmonary Blood Flow After Enaliprilat|Pulmonary blood flow 20 minutes after enalaprilat
505967|NCT00741156|O3|Outcome|Pulmonary Blood Flow Baseline|Pulmonary blood flow baseline condition
505968|NCT00741156|O2|Outcome|Systemic Blood Flow After Enalaprilat|Systemic blood flow 20 minutes after enalaprilat
505969|NCT00741156|O1|Outcome|Systemic Blood Flow Baseline|Systemic blood flow in baseline condition
505970|NCT00741156|E1|Reported Event|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
505971|NCT00741104|B1|Baseline|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
506134|NCT00740779|B2|Baseline|Silodosin 8 mg|Silodosin 8 mg daily
505972|NCT00741104|P1|Participant Flow|RA Patients|Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for >= the past 12 months.
505973|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
505974|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
505975|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
505976|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
505977|NCT00741104|E1|Reported Event|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
505978|NCT00741091|B1|Baseline|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505979|NCT00741091|P1|Participant Flow|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505980|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505981|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505982|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505983|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505984|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505985|NCT00741091|E1|Reported Event|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
505986|NCT00741039|B3|Baseline|Total|Total of all reporting groups
505987|NCT00741039|B2|Baseline|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
505988|NCT00741039|B1|Baseline|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
505989|NCT00741039|P2|Participant Flow|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
505990|NCT00741039|P1|Participant Flow|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
505991|NCT00741039|O2|Outcome|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
505992|NCT00741039|O1|Outcome|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
505993|NCT00741039|E2|Reported Event|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
505994|NCT00741039|E1|Reported Event|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
505995|NCT00741026|B1|Baseline|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days."
505996|NCT00741026|P1|Participant Flow|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days.~Randomization information not available."
505997|NCT00741026|O2|Outcome|Olanzapine|
505998|NCT00741026|O1|Outcome|Placebo|
505999|NCT00741026|O2|Outcome|Olanzapine|
506000|NCT00741026|O1|Outcome|Placebo|
506001|NCT00741026|O2|Outcome|Olanzapine|
506002|NCT00741026|O1|Outcome|Placebo|
506003|NCT00741026|O2|Outcome|Olanzapine|
506004|NCT00741026|O1|Outcome|Placebo|
506005|NCT00741026|O2|Outcome|Olanzapine|
506006|NCT00741026|O1|Outcome|Placebo|
506007|NCT00741026|O2|Outcome|Olanzapine|
506008|NCT00741026|O1|Outcome|Placebo|
506009|NCT00741026|O2|Outcome|Olanzapine|
506010|NCT00741026|O1|Outcome|Placebo|
506011|NCT00741026|O2|Outcome|Olanzapine|
506012|NCT00741026|O1|Outcome|Placebo|
506013|NCT00741026|O2|Outcome|Olanzapine|
506014|NCT00741026|O1|Outcome|Placebo|
506015|NCT00741026|O2|Outcome|Olanzapine|
506016|NCT00741026|O1|Outcome|Placebo|
506017|NCT00741026|O2|Outcome|Olanzapine|
506018|NCT00741026|O1|Outcome|Placebo|
506019|NCT00741026|O2|Outcome|Olanzapine|
506020|NCT00741026|O1|Outcome|Placebo|
506021|NCT00741026|E2|Reported Event|Olanzapine|
506022|NCT00741026|E1|Reported Event|Placebo|Placebo : (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
506023|NCT00741013|B4|Baseline|Total|Total of all reporting groups
506135|NCT00740779|B1|Baseline|Silodosin 4 mg|Silodosin 4 mg daily
506024|NCT00741013|B3|Baseline|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
506025|NCT00741013|B2|Baseline|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
506026|NCT00741013|B1|Baseline|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
506027|NCT00741013|P3|Participant Flow|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
506028|NCT00741013|P2|Participant Flow|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
506029|NCT00741013|P1|Participant Flow|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
506030|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
506031|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
506032|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
506033|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
506034|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
506035|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
506036|NCT00741013|E3|Reported Event|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
506037|NCT00741013|E2|Reported Event|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
506038|NCT00741013|E1|Reported Event|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
506039|NCT00740870|B1|Baseline|Enrolled Cohort|All subjects enrolled
506040|NCT00740870|P1|Participant Flow|Enrolled|All subjects enrolled (n=171)
506041|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
506042|NCT00740870|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
506043|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
506044|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
506045|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
506046|NCT00740870|O1|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
506047|NCT00740870|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
506048|NCT00740870|O1|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
506049|NCT00740870|O1|Outcome|Implanted >24 Hour Cohort|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
506050|NCT00740870|E1|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
506051|NCT00740857|B4|Baseline|Total|Total of all reporting groups
506052|NCT00740857|B3|Baseline|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506053|NCT00740857|B2|Baseline|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506054|NCT00740857|B1|Baseline|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506055|NCT00740857|P3|Participant Flow|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506056|NCT00740857|P2|Participant Flow|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506057|NCT00740857|P1|Participant Flow|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506058|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506059|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506060|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506061|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506062|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506063|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506064|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506065|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506066|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506067|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506068|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506069|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506070|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506071|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506073|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506074|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506075|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506076|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506077|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506078|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506079|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506080|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506081|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506082|NCT00740857|E3|Reported Event|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
506083|NCT00740857|E2|Reported Event|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
506084|NCT00740857|E1|Reported Event|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
506085|NCT00740831|B4|Baseline|Total|Total of all reporting groups
506086|NCT00740831|B3|Baseline|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
506087|NCT00740831|B2|Baseline|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506088|NCT00740831|B1|Baseline|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506089|NCT00740831|P3|Participant Flow|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
506090|NCT00740831|P2|Participant Flow|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506091|NCT00740831|P1|Participant Flow|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506092|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
506093|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506094|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506095|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
506096|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506097|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506098|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
506099|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506100|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506101|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
506102|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506103|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506104|NCT00740831|E3|Reported Event|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
506105|NCT00740831|E2|Reported Event|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506106|NCT00740831|E1|Reported Event|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
506107|NCT00740792|B5|Baseline|Total|Total of all reporting groups
506108|NCT00740792|B4|Baseline|Placebo|placebo control
506109|NCT00740792|B3|Baseline|Fluticasone Propionate|active comparator of fluticasone propionate
506110|NCT00740792|B2|Baseline|Azelastine HCL|active comparator of azelastine HCl
506111|NCT00740792|B1|Baseline|MP29-02|azelastine HCl/fluticasone propionate
506112|NCT00740792|P4|Participant Flow|Placebo|placebo control
506113|NCT00740792|P3|Participant Flow|Fluticasone Propionate|active comparator of fluticasone propionate
506114|NCT00740792|P2|Participant Flow|Azelastine HCL|active comparator of azelastine HCl
506115|NCT00740792|P1|Participant Flow|MP29-02|azelastine HCl/fluticasone propionate
506116|NCT00740792|O4|Outcome|Placebo|placebo control
506117|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
506118|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
506119|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
506120|NCT00740792|O4|Outcome|Placebo|placebo control
506121|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
506122|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
506123|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
506124|NCT00740792|O4|Outcome|Placebo|placebo control
506125|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
506126|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
506127|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
506128|NCT00740792|E4|Reported Event|Placebo|placebo control
506129|NCT00740792|E3|Reported Event|Fluticasone Propionate|active comparator of fluticasone propionate
506130|NCT00740792|E2|Reported Event|Azelastine HCL|active comparator of azelastine HCl
506131|NCT00740792|E1|Reported Event|MP29-02|azelastine HCl/fluticasone propionate
506145|NCT00740727|B1|Baseline|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
506146|NCT00740727|P1|Participant Flow|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
506147|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
506148|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
506149|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
506150|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
506151|NCT00740714|B4|Baseline|Total|Total of all reporting groups
506152|NCT00740714|B3|Baseline|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506153|NCT00740714|B2|Baseline|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506154|NCT00740714|B1|Baseline|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506155|NCT00740714|P3|Participant Flow|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506156|NCT00740714|P2|Participant Flow|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506157|NCT00740714|P1|Participant Flow|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506158|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506159|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506160|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506161|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506162|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506163|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506164|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506165|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506166|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506167|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506168|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506169|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506170|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506171|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506172|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506173|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506174|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506175|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506176|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506177|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506178|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506179|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506180|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506181|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506182|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506183|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506184|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506185|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506186|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506187|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506188|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506189|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506190|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506192|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506193|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506194|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506195|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506196|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506197|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506198|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506199|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506200|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506201|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506202|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506203|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506204|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506205|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506206|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506207|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506208|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506209|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506210|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506211|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506212|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506213|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506214|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506215|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506216|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506217|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506218|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506219|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506220|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506221|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506222|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506223|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506224|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506225|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506226|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506227|NCT00740714|E3|Reported Event|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
506228|NCT00740714|E2|Reported Event|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
506229|NCT00740714|E1|Reported Event|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
506230|NCT00740636|B3|Baseline|Total|Total of all reporting groups
506231|NCT00740636|B2|Baseline|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
506232|NCT00740636|B1|Baseline|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
506233|NCT00740636|P2|Participant Flow|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
506234|NCT00740636|P1|Participant Flow|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
506235|NCT00740636|O2|Outcome|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
506236|NCT00740636|O1|Outcome|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
506237|NCT00740636|E2|Reported Event|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
506238|NCT00740636|E1|Reported Event|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
506239|NCT00740597|B1|Baseline|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
506240|NCT00740597|P1|Participant Flow|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
506241|NCT00740597|O1|Outcome|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
506242|NCT00740597|E1|Reported Event|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
506243|NCT00740584|B1|Baseline|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
506244|NCT00740584|P1|Participant Flow|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
506245|NCT00740584|O1|Outcome|Open Label Active|
506246|NCT00740584|E1|Reported Event|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
506247|NCT00740480|B1|Baseline|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
506248|NCT00740480|P1|Participant Flow|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
506249|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
506250|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
506251|NCT00740220|B1|Baseline|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
506252|NCT00740220|P1|Participant Flow|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
506253|NCT00740220|O1|Outcome|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
506254|NCT00740220|E1|Reported Event|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
506255|NCT00740207|B3|Baseline|Total|Total of all reporting groups
506256|NCT00740207|B2|Baseline|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506257|NCT00740207|B1|Baseline|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506258|NCT00740207|P2|Participant Flow|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506259|NCT00740207|P1|Participant Flow|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506260|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506261|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506262|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506300|NCT00739999|P2|Participant Flow|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Age 10 - 17 years, at Tanner Stage 2+. Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained.
506497|NCT00739908|P2|Participant Flow|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506263|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506264|NCT00740207|O4|Outcome|VAS Score After Injection of VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506265|NCT00740207|O3|Outcome|VAS Score Prior to Injection of VISIPAQUE 270|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
506266|NCT00740207|O2|Outcome|VAS Score After Injection of ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506267|NCT00740207|O1|Outcome|VAS Score Prior to Injection of ISOVUE 250|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
506268|NCT00740207|E2|Reported Event|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506269|NCT00740207|E1|Reported Event|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
506270|NCT00740181|B1|Baseline|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
506271|NCT00740181|P1|Participant Flow|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
506272|NCT00740181|O1|Outcome|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
506273|NCT00740181|E1|Reported Event|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
506274|NCT00740051|B3|Baseline|Total|Total of all reporting groups
506275|NCT00740051|B2|Baseline|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506276|NCT00740051|B1|Baseline|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506277|NCT00740051|P2|Participant Flow|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506278|NCT00740051|P1|Participant Flow|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506279|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506280|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506281|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506282|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506283|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506284|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506285|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506286|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506287|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506288|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506289|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506290|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506291|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506292|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506293|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506294|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506295|NCT00740051|E2|Reported Event|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
506296|NCT00740051|E1|Reported Event|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
506297|NCT00739999|B3|Baseline|Total|Total of all reporting groups
506298|NCT00739999|B2|Baseline|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506299|NCT00739999|B1|Baseline|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506342|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506301|NCT00739999|P1|Participant Flow|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Age 6 - 10 years, at Tanner Stage 1. Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target low-density lipoprotein cholesterol (LDL-C) was not attained.
506302|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg, 20 mg): Tanner Stages 1 and 2+|Tanner Stage 1: Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated; Tanner Stage 2+: Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506303|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506304|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506305|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506306|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506307|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506308|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506309|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506310|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506311|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506312|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506313|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506314|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506315|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506316|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506317|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506318|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506319|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506320|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506321|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506322|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506323|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506324|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506325|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506326|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506327|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506328|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506329|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506330|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506331|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506332|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506333|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506334|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506335|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506336|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506337|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506338|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506339|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506340|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506341|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506343|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506344|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506345|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506346|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506347|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506348|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506349|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506350|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506351|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506352|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506353|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506354|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506355|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506356|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506357|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506358|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506359|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506360|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506361|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506362|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506363|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506364|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
506365|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506366|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
506367|NCT00739999|O2|Outcome|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
506368|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506369|NCT00739999|E2|Reported Event|All Subjects (10 mg, 20 mg): Tanner Stage 2+|Atorvastatin: subjects who stayed at initial dose of 10 mg/day for duration of study and subjects who titrated to 20 mg/day after Week 4 if target LDL-C was not attained and study drug was well tolerated.
506370|NCT00739999|E1|Reported Event|All Subjects (5 mg, 10 mg): Tanner Stage 1|Atorvastatin: subjects who stayed at initial dose of 5 mg/day for duration of study and subjects who titrated after Week 4 to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
506371|NCT00739973|B10|Baseline|Total|Total of all reporting groups
506372|NCT00739973|B9|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506373|NCT00739973|B8|Baseline|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506374|NCT00739973|B7|Baseline|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506375|NCT00739973|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506490|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
506376|NCT00739973|B5|Baseline|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506377|NCT00739973|B4|Baseline|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506378|NCT00739973|B3|Baseline|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506379|NCT00739973|B2|Baseline|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506380|NCT00739973|B1|Baseline|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506381|NCT00739973|P9|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506382|NCT00739973|P8|Participant Flow|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506383|NCT00739973|P7|Participant Flow|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506384|NCT00739973|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506385|NCT00739973|P5|Participant Flow|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506386|NCT00739973|P4|Participant Flow|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506387|NCT00739973|P3|Participant Flow|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506388|NCT00739973|P2|Participant Flow|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506389|NCT00739973|P1|Participant Flow|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506390|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506491|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
506391|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506392|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506393|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506394|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506395|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506396|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506397|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506398|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506399|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506400|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506401|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506402|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506403|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506404|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506405|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506492|NCT00739934|E2|Reported Event|Voriconazole Oral|Voriconazole oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
506406|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506407|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506408|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506409|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506410|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506411|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506412|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506413|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506414|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506415|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506416|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506417|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506418|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506419|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506420|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506493|NCT00739934|E1|Reported Event|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
506421|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506422|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506423|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506424|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506425|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506426|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506427|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506428|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506429|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506430|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506431|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506432|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506433|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506434|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506435|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506494|NCT00739908|B3|Baseline|Total|Total of all reporting groups
506495|NCT00739908|B2|Baseline|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506436|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506437|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506438|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506439|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506440|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506441|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506442|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506443|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506444|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506445|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506446|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506447|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506448|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506449|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506450|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506496|NCT00739908|B1|Baseline|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506451|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506452|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506453|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506454|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506455|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506456|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506457|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506458|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506459|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506460|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506461|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506462|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506463|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506464|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506465|NCT00739973|E9|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506466|NCT00739973|E8|Reported Event|Aliskiren/Amlodipine 300/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506467|NCT00739973|E7|Reported Event|Aliskiren/Amlodipine 150/10 mg Tablet|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506468|NCT00739973|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506469|NCT00739973|E5|Reported Event|Amlodipine 10 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
506470|NCT00739973|E4|Reported Event|Amlodipine 5 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506471|NCT00739973|E3|Reported Event|Aliskiren 300 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506472|NCT00739973|E2|Reported Event|Aliskiren 150 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
506473|NCT00739973|E1|Reported Event|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
506474|NCT00739934|B1|Baseline|All Participants|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
506475|NCT00739934|P1|Participant Flow|All Participants|Voriconazole intravenous (IV) multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
506476|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
506477|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
506478|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
506479|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
506480|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
506481|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
506482|NCT00739934|O1|Outcome|All Treatments|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
506483|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
506484|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
506485|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
506486|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
506487|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
506488|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
506489|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
507620|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
506498|NCT00739908|P1|Participant Flow|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506499|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506500|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506501|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506502|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506503|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506504|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506505|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506506|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506507|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506508|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506509|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506510|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506511|NCT00739908|O2|Outcome|Oral Placebo TID|No active medication, the same as a Sugar Pill
506512|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational Reversible Monoamine Oxidase Inhibitor (MAOI)
506513|NCT00739908|E2|Reported Event|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
506514|NCT00739908|E1|Reported Event|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
506515|NCT00739882|B3|Baseline|Total|Total of all reporting groups
506516|NCT00739882|B2|Baseline|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506517|NCT00739882|B1|Baseline|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506518|NCT00739882|P2|Participant Flow|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506519|NCT00739882|P1|Participant Flow|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506520|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506521|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506522|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506523|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506524|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506548|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
506525|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506526|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506527|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506528|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506529|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506530|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
506531|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
506532|NCT00739882|E4|Reported Event|Placebo - Open-label Period|
506533|NCT00739882|E3|Reported Event|Efalizumab - Open-label Period|
506534|NCT00739882|E2|Reported Event|Placebo - Double-blind Period|
506535|NCT00739882|E1|Reported Event|Efalizumab - Double-blind Period|
506536|NCT00739765|B4|Baseline|Total|Total of all reporting groups
506537|NCT00739765|B3|Baseline|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
506538|NCT00739765|B2|Baseline|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
506539|NCT00739765|B1|Baseline|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
506540|NCT00739765|P3|Participant Flow|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
506541|NCT00739765|P2|Participant Flow|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
506542|NCT00739765|P1|Participant Flow|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
506543|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
506544|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
506545|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
506546|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
506547|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
506643|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
506549|NCT00739765|E3|Reported Event|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
506550|NCT00739765|E2|Reported Event|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
506551|NCT00739765|E1|Reported Event|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
506552|NCT00739752|B7|Baseline|Total|Total of all reporting groups
506553|NCT00739752|B6|Baseline|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
506554|NCT00739752|B5|Baseline|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
506555|NCT00739752|B4|Baseline|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
506556|NCT00739752|B3|Baseline|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
506557|NCT00739752|B2|Baseline|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
506558|NCT00739752|B1|Baseline|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
506559|NCT00739752|P6|Participant Flow|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
506560|NCT00739752|P5|Participant Flow|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
506561|NCT00739752|P4|Participant Flow|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
506562|NCT00739752|P3|Participant Flow|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
506563|NCT00739752|P2|Participant Flow|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
506564|NCT00739752|P1|Participant Flow|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
506565|NCT00739752|O6|Outcome|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
506566|NCT00739752|O5|Outcome|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
506567|NCT00739752|O4|Outcome|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
506568|NCT00739752|O3|Outcome|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
506569|NCT00739752|O2|Outcome|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
506570|NCT00739752|O1|Outcome|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
506571|NCT00739752|E6|Reported Event|Loss-Framed-Recommended|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.~Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine."
506572|NCT00739752|E5|Reported Event|Loss-Framed-Offered|"Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.~Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine."
506573|NCT00739752|E4|Reported Event|Gain-Framed-Recommended|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.~Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine."
506574|NCT00739752|E3|Reported Event|Gain-Framed-Offered|"Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.~Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine."
506575|NCT00739752|E2|Reported Event|Non-Framed-Recommended|"Non-Framed, Information Only Condition. Vaccine Recommended.~Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine."
506576|NCT00739752|E1|Reported Event|Non-Framed-Offered|"Non-Framed, Information Only Condition. Vaccine Offered.~Non-Framed-Offered: Subjects received information only and are offered the vaccine."
506577|NCT00739674|B3|Baseline|Total|Total of all reporting groups
506602|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
507621|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
506578|NCT00739674|B2|Baseline|Diet Management and Losartan-Based Regimen (DML Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
506579|NCT00739674|B1|Baseline|Losartan-Based Regimen Alone (L Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
506580|NCT00739674|P2|Participant Flow|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.
506581|NCT00739674|P1|Participant Flow|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure.
506582|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506583|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506584|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506585|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506586|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506587|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506588|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506589|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506590|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506591|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506592|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506593|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506594|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506595|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506596|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506597|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506598|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506599|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506600|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506601|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506603|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506604|NCT00739674|E2|Reported Event|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
506605|NCT00739674|E1|Reported Event|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
506606|NCT00739661|B3|Baseline|Total|Total of all reporting groups
506607|NCT00739661|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506608|NCT00739661|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506609|NCT00739661|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506610|NCT00739661|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506611|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506612|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506613|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506614|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506615|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506616|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506617|NCT00739661|E2|Reported Event|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506618|NCT00739661|E1|Reported Event|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
506619|NCT00739648|B3|Baseline|Total|Total of all reporting groups
506620|NCT00739648|B2|Baseline|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506621|NCT00739648|B1|Baseline|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506622|NCT00739648|P2|Participant Flow|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506623|NCT00739648|P1|Participant Flow|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506624|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
506625|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
506626|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
506627|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
506628|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506629|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506630|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily (BID)via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
506631|NCT00739648|O1|Outcome|Placebo|Placebo inhaled twice daily (BID) via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
506632|NCT00739648|E2|Reported Event|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506633|NCT00739648|E1|Reported Event|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
506634|NCT00739596|B3|Baseline|Total|Total of all reporting groups
506635|NCT00739596|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
506636|NCT00739596|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
506637|NCT00739596|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
506638|NCT00739596|P1|Participant Flow|Aliskiren Hydrochlorothiazide (HCTZ)|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
506639|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
506640|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
506641|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
506642|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
506644|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
506645|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
506646|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
506647|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
506648|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
506649|NCT00739596|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks.
506650|NCT00739596|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks.
506651|NCT00739583|B3|Baseline|Total|Total of all reporting groups
506652|NCT00739583|B2|Baseline|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
506653|NCT00739583|B1|Baseline|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
506654|NCT00739583|P2|Participant Flow|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
506655|NCT00739583|P1|Participant Flow|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
506656|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
506657|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
506658|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
506659|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
506660|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
506661|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
506662|NCT00739583|E2|Reported Event|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
506663|NCT00739583|E1|Reported Event|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
506664|NCT00739336|B3|Baseline|Total|Total of all reporting groups
506665|NCT00739336|B2|Baseline|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
506666|NCT00739336|B1|Baseline|Intervention|"A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.~Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings."
506667|NCT00739336|P2|Participant Flow|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
506668|NCT00739336|P1|Participant Flow|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
506669|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
506670|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
506671|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
506672|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
506673|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
506674|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
506675|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
506676|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
506677|NCT00739336|E2|Reported Event|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
506678|NCT00739336|E1|Reported Event|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
506774|NCT00738972|E3|Reported Event|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
506679|NCT00739310|B1|Baseline|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
506680|NCT00739310|P1|Participant Flow|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
506681|NCT00739310|O2|Outcome|Post Vest Treatment|12 months of intervention 2 x daily Vest Therapy
506682|NCT00739310|O1|Outcome|Pre-Treatment|Prior to Vest Treatment
506683|NCT00739310|E1|Reported Event|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
506684|NCT00739297|B1|Baseline|All Participants|Combined participants from all arms.
506685|NCT00739297|P7|Participant Flow|Total|"Consistent with the incomplete-block design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not~received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period."
506686|NCT00739297|P6|Participant Flow|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506687|NCT00739297|P5|Participant Flow|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506688|NCT00739297|P4|Participant Flow|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506689|NCT00739297|P3|Participant Flow|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506690|NCT00739297|P2|Participant Flow|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506691|NCT00739297|P1|Participant Flow|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506692|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506693|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506694|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506695|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506696|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506775|NCT00738972|E2|Reported Event|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
507622|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
506697|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506698|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506699|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506700|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506701|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506702|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506703|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506704|NCT00739297|O2|Outcome|Montelukast+ Placebo|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Placebo for Albuterol (data for each patient are pooled across all 3 administrations of placebo for albuterol, as added to active montelukast)
506705|NCT00739297|O1|Outcome|Montelukast+Albuterol|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Albuterol (data for each patient are pooled across all 3 administrations of active albuterol, as added to active montelukast)
506706|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506707|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506708|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506709|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506710|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506711|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506728|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506712|NCT00739297|E6|Reported Event|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506713|NCT00739297|E5|Reported Event|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506714|NCT00739297|E4|Reported Event|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506715|NCT00739297|E3|Reported Event|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506716|NCT00739297|E2|Reported Event|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506717|NCT00739297|E1|Reported Event|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
506718|NCT00739102|B1|Baseline|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506719|NCT00739102|P1|Participant Flow|S.M.A.R.T.® Nitinol Stent System|The Cordis S.M.A.R.T. ®Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506720|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506721|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506722|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506723|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506724|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506725|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506726|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506727|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
507123|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
506729|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506730|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506731|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506732|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506733|NCT00739102|E1|Reported Event|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
506734|NCT00739063|B1|Baseline|Tarceva Daily|Tarceva oral 150 mg daily.
506735|NCT00739063|P1|Participant Flow|Tarceva Daily|Tarceva oral 150 mg daily.
506736|NCT00739063|O1|Outcome|Tarceva Daily|Tarceva oral 150 mg daily.
506737|NCT00739063|E1|Reported Event|Tarceva Daily|Tarceva oral 150 mg daily.
506738|NCT00739050|B1|Baseline|All Participants|"All Randomized patients.~Laboratory values were only avaliable for 3 participants for Total Cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)"
506739|NCT00739050|P2|Participant Flow|Placebo|Placebo daily at nights for 12 weeks
506740|NCT00739050|P1|Participant Flow|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
506741|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
506742|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
506743|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
506744|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
506745|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
506746|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
506747|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
506748|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
506749|NCT00739050|E2|Reported Event|Placebo|Placebo daily at nights for 12 weeks
506750|NCT00739050|E1|Reported Event|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
506751|NCT00739024|B3|Baseline|Total|Total of all reporting groups
506752|NCT00739024|B2|Baseline|Placebo|Random assignment to placebo
506753|NCT00739024|B1|Baseline|Active Treatment|Random assignment to active treatment
506754|NCT00739024|P2|Participant Flow|Placebo|Random assignment to placebo
506755|NCT00739024|P1|Participant Flow|Active Treatment|Random assignment to active treatment
506756|NCT00739024|O2|Outcome|Placebo|Random assignment to placebo
506757|NCT00739024|O1|Outcome|Active Treatment|Random assignment to active treatment
506758|NCT00739024|E2|Reported Event|Placebo|Random assignment to placebo
506759|NCT00739024|E1|Reported Event|Active Treatment|Random assignment to active treatment
506760|NCT00738972|B5|Baseline|Total|Total of all reporting groups
506761|NCT00738972|B4|Baseline|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
506762|NCT00738972|B3|Baseline|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
506763|NCT00738972|B2|Baseline|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
506764|NCT00738972|B1|Baseline|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
506765|NCT00738972|P4|Participant Flow|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
506766|NCT00738972|P3|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
506767|NCT00738972|P2|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
506768|NCT00738972|P1|Participant Flow|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
506769|NCT00738972|O4|Outcome|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
506770|NCT00738972|O3|Outcome|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
506771|NCT00738972|O2|Outcome|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
506772|NCT00738972|O1|Outcome|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
506773|NCT00738972|E4|Reported Event|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
506776|NCT00738972|E1|Reported Event|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
506777|NCT00738881|B3|Baseline|Total|Total of all reporting groups
506778|NCT00738881|B2|Baseline|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
506779|NCT00738881|B1|Baseline|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
506780|NCT00738881|P2|Participant Flow|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
506781|NCT00738881|P1|Participant Flow|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
506782|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
506783|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
506784|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
506785|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
506786|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
506787|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
506788|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
506789|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
506790|NCT00738881|E2|Reported Event|Arm II|pemetrexed disodium: Given IV
506791|NCT00738881|E1|Reported Event|Arm I|erlotinib hydrochloride: Given orally
506792|NCT00738699|B3|Baseline|Total|Total of all reporting groups
506793|NCT00738699|B2|Baseline|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506794|NCT00738699|B1|Baseline|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506795|NCT00738699|P2|Participant Flow|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506796|NCT00738699|P1|Participant Flow|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506797|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506950|NCT00738361|E1|Reported Event|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
507623|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
506798|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506799|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506800|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506801|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506802|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506803|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506804|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506805|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506806|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506807|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
507120|NCT00737568|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily
506808|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506809|NCT00738699|E2|Reported Event|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506810|NCT00738699|E1|Reported Event|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
506811|NCT00738673|B3|Baseline|Total|Total of all reporting groups
506812|NCT00738673|B2|Baseline|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506813|NCT00738673|B1|Baseline|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506814|NCT00738673|P2|Participant Flow|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506815|NCT00738673|P1|Participant Flow|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506816|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506817|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506818|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506819|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506820|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506821|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506822|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506823|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506824|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506825|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506826|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506827|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
507624|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
506828|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506829|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506830|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506831|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506832|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506833|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506834|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506835|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506836|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506837|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506838|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506839|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506840|NCT00738673|E2|Reported Event|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506841|NCT00738673|E1|Reported Event|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
506842|NCT00738543|B1|Baseline|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506843|NCT00738543|P1|Participant Flow|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506844|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506845|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506846|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506847|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506848|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506849|NCT00738543|E1|Reported Event|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
506850|NCT00738530|B3|Baseline|Total|Total of all reporting groups
506851|NCT00738530|B2|Baseline|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506852|NCT00738530|B1|Baseline|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506853|NCT00738530|P2|Participant Flow|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506854|NCT00738530|P1|Participant Flow|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) was administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
506975|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506855|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506856|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506857|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506858|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506859|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506860|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506861|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506862|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506863|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506864|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506865|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506866|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506867|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506868|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506869|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506870|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506871|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506872|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506873|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506874|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506875|NCT00738530|E2|Reported Event|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506876|NCT00738530|E1|Reported Event|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
506877|NCT00738426|B3|Baseline|Total|Total of all reporting groups
506878|NCT00738426|B2|Baseline|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
506879|NCT00738426|B1|Baseline|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
506880|NCT00738426|P2|Participant Flow|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
506881|NCT00738426|P1|Participant Flow|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
506882|NCT00738426|O2|Outcome|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
506883|NCT00738426|O1|Outcome|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
506884|NCT00738426|E2|Reported Event|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
506885|NCT00738426|E1|Reported Event|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
506886|NCT00738400|B3|Baseline|Total|Total of all reporting groups
506887|NCT00738400|B2|Baseline|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506888|NCT00738400|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506889|NCT00738400|P2|Participant Flow|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506890|NCT00738400|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506891|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506892|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506893|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506894|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506895|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506896|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506897|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506898|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506899|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506900|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506901|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506902|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506903|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506904|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506905|NCT00738400|E2|Reported Event|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
506906|NCT00738400|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
506907|NCT00738374|B4|Baseline|Total|Total of all reporting groups
506908|NCT00738374|B3|Baseline|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506909|NCT00738374|B2|Baseline|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506910|NCT00738374|B1|Baseline|CLB + R: Not Randomized|Participants began a 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants who completed the induction treatment with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
507121|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
526177|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
506911|NCT00738374|P4|Participant Flow|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506912|NCT00738374|P3|Participant Flow|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506913|NCT00738374|P2|Participant Flow|CLB + R: Completed Induction Treament But Not Randomized|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants were not randomized to receive further treatment or observation.
506914|NCT00738374|P1|Participant Flow|Chlorambucil (CLB) Plus (+) Rituximab (R): Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 milligrams per square meter (mg/m^2), orally (PO) as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, intravenously (IV), on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with complete response (CR), complete response with incomplete bone marrow recovery (CRi), or partial response (PR) were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
506915|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506916|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506917|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506918|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506919|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506920|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506921|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506922|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
507122|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
506923|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506924|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506925|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506926|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506927|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506928|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506929|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506930|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506931|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506932|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506933|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506976|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506934|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506935|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
506936|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506937|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506938|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
506939|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506940|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506941|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506942|NCT00738374|E3|Reported Event|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
506943|NCT00738374|E2|Reported Event|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
506944|NCT00738374|E1|Reported Event|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
506945|NCT00738361|B1|Baseline|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
506946|NCT00738361|P1|Participant Flow|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
506947|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
506948|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
506949|NCT00738361|O1|Outcome|Nab-paclitaxel|"Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.~nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days."
507114|NCT00737594|E2|Reported Event|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
506951|NCT00738283|B1|Baseline|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
506952|NCT00738283|P1|Participant Flow|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
506953|NCT00738283|O1|Outcome|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
506954|NCT00738283|E1|Reported Event|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
506955|NCT00738062|B4|Baseline|Total|Total of all reporting groups
506956|NCT00738062|B3|Baseline|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506957|NCT00738062|B2|Baseline|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506958|NCT00738062|B1|Baseline|Open-Label Droxidopa|Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
506959|NCT00738062|P3|Participant Flow|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506960|NCT00738062|P2|Participant Flow|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506961|NCT00738062|P1|Participant Flow|Open-Label Droxidopa|3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
506962|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506963|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506964|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506965|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506966|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506967|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506968|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506969|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506970|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506971|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506972|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506973|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506974|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
507115|NCT00737594|E1|Reported Event|Placebo|Placebo: 0 mcg capsules three times daily (TID)
507116|NCT00737568|B3|Baseline|Total|Total of all reporting groups
506977|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506978|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506979|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506980|NCT00738062|E5|Reported Event|Total Droxidopa|All Patients exposed to droxidopa
506981|NCT00738062|E4|Reported Event|Long-Term Follow-up|Open-label treatment with droxidopa (t.i.d) following the double-blind randomization phase.
506982|NCT00738062|E3|Reported Event|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506983|NCT00738062|E2|Reported Event|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
506984|NCT00738062|E1|Reported Event|Three Month Open-Label Droxidopa|all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
506985|NCT00738049|B3|Baseline|Total|Total of all reporting groups
506986|NCT00738049|B2|Baseline|Group 2|Group 2 received placebo during Phase 1 then oral Darusentan 100 mg during Phase 2.
506987|NCT00738049|B1|Baseline|Group 1|Group 1 received oral Darusentan 100mg during Phase 1 then placebo during Phase 2.
506988|NCT00738049|P2|Participant Flow|Placebo, Then Darusentan 100mg|Patients were randomized to oral placebo for 14 days, then underwent PET imaging. Study patients then received Darusentan 100mg for 14 days. The patients underwent cardiac PET imaging followed by a 14 day washout period and final PET scan. Patients and physicians were blinded to medication assignment.
506989|NCT00738049|P1|Participant Flow|Darusentan Then Placebo,|Patients were randomized to oral Darusentan 100mg for 14 days and then underwent cardiac PET imaging. They then received placebo for 14 days and underwent PET imaging, followed by a washout period of 14 days and completed the final cardiac PET scan. Patients and physicians were blinded to medication assignment.
506990|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a assessment of CFR while receiving darusentan
506991|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of CFR before receiving darusentan or placebo
506992|NCT00738049|O4|Outcome|Baseline at Hyperemia|All patients underwent a baseline assessment of hyperemic flow before receiving darusentan or placebo
506993|NCT00738049|O3|Outcome|Baseline at Rest|All patients underwent a baseline assessment of resting flow before receiving darusentan or placebo
506994|NCT00738049|O2|Outcome|Darusentan 100mg at Hyperemia|All patients underwent assessment of hyperemic flow while receiving darusentan
506995|NCT00738049|O1|Outcome|Darusentan 100mg at Rest|All patients underwent assessment of rest flow while receiving darusentan
506996|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a baseline assessment of Markovian homogeneity while taking darusentan
506997|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of Markovian homogeneity before receiving darusentan or placebo
506998|NCT00738049|E2|Reported Event|Group 2|Received placebo during Phase 1, Darusentan 100mg during Phase 2
506999|NCT00738049|E1|Reported Event|Group 1|Darusentan 100mg during Phase 1, Placebo during Phase 2
507000|NCT00738023|B3|Baseline|Total|Total of all reporting groups
507001|NCT00738023|B2|Baseline|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
507002|NCT00738023|B1|Baseline|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
507003|NCT00738023|P2|Participant Flow|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
507004|NCT00738023|P1|Participant Flow|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
507005|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours~Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks~Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours~Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
507006|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours~Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks~Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours~Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
507007|NCT00738023|O2|Outcome|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
507008|NCT00738023|O1|Outcome|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
507009|NCT00738023|E2|Reported Event|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
507010|NCT00738023|E1|Reported Event|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
507011|NCT00737737|B3|Baseline|Total|Total of all reporting groups
507012|NCT00737737|B2|Baseline|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
507013|NCT00737737|B1|Baseline|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
507014|NCT00737737|P2|Participant Flow|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
507015|NCT00737737|P1|Participant Flow|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
507016|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
507017|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
507018|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
507019|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
507020|NCT00737737|E2|Reported Event|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
507021|NCT00737737|E1|Reported Event|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
507022|NCT00737711|B1|Baseline|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507023|NCT00737711|P1|Participant Flow|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507024|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507025|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507026|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507027|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507028|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507029|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507030|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507031|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507032|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507033|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507034|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507035|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507036|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507037|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507038|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
526178|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
507039|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507040|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507041|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507042|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507043|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507044|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507045|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507046|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507047|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507048|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507049|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507050|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507051|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507052|NCT00737711|E1|Reported Event|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
507053|NCT00737672|B3|Baseline|Total|Total of all reporting groups
507054|NCT00737672|B2|Baseline|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis."
507055|NCT00737672|B1|Baseline|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis."
507056|NCT00737672|P2|Participant Flow|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507057|NCT00737672|P1|Participant Flow|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507058|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507059|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507060|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507061|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507117|NCT00737568|B2|Baseline|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507625|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507062|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507063|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507064|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507065|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507066|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507067|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507068|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507069|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507070|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507071|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507072|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507073|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507074|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507075|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507076|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507077|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507078|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507079|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507118|NCT00737568|B1|Baseline|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507119|NCT00737568|P2|Participant Flow|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507080|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507081|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507082|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507083|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507084|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507085|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507086|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507087|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507088|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
507089|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
507090|NCT00737672|E2|Reported Event|PTA Treatment Group|Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
507091|NCT00737672|E1|Reported Event|VIABAHN Treatment Group|Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
507092|NCT00737633|B3|Baseline|Total|Total of all reporting groups
507093|NCT00737633|B2|Baseline|72-week Population|subjects who were randomized to active during previous study
507094|NCT00737633|B1|Baseline|16-week Population|subjects who were randomized to placebo in previous study
507095|NCT00737633|P2|Participant Flow|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
507096|NCT00737633|P1|Participant Flow|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
507097|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
507098|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
507099|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
507100|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
507101|NCT00737633|E2|Reported Event|72-week Population|subjects who were randomized to active during previous study
507102|NCT00737633|E1|Reported Event|16-week Population|subjects who were randomized to placebo in previous study
507103|NCT00737594|B4|Baseline|Total|Total of all reporting groups
507104|NCT00737594|B3|Baseline|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
507105|NCT00737594|B2|Baseline|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
507106|NCT00737594|B1|Baseline|Placebo|Placebo: 0 mcg capsules three times daily (TID)
507107|NCT00737594|P3|Participant Flow|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
507108|NCT00737594|P2|Participant Flow|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
507109|NCT00737594|P1|Participant Flow|Placebo|Placebo: 0 mcg capsules three times daily (TID)
507110|NCT00737594|O3|Outcome|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
507111|NCT00737594|O2|Outcome|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
507112|NCT00737594|O1|Outcome|Placebo|Placebo: 0 mcg capsules three times daily (TID)
507113|NCT00737594|E3|Reported Event|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
507124|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507125|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507126|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507127|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507128|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507129|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507130|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507131|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507132|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507133|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507134|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507135|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507136|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507137|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507138|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507139|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507140|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507141|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507142|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507143|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507144|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507145|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507146|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507147|NCT00737568|E2|Reported Event|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
507148|NCT00737568|E1|Reported Event|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
507149|NCT00737529|B1|Baseline|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
507150|NCT00737529|P1|Participant Flow|Lenalidomide|"Single agent lenalidomide~Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal."
507151|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507152|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507153|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507154|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507155|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507182|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507626|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507156|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507157|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507158|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507159|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507160|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507161|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
507162|NCT00737529|E1|Reported Event|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
507163|NCT00737477|B1|Baseline|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507164|NCT00737477|P1|Participant Flow|Mircera in Chronic Kidney Disease (CKD)-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507165|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507166|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507167|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507183|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507627|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507168|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507169|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507170|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507171|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507172|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507173|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507174|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507175|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507176|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507177|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507178|NCT00737477|E1|Reported Event|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
507179|NCT00737464|B1|Baseline|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507180|NCT00737464|P1|Participant Flow|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507181|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507856|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507184|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507185|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507186|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507187|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507188|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507189|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507190|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507191|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507192|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507193|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507194|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507195|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507196|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507197|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507198|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507199|NCT00737464|E1|Reported Event|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
507200|NCT00737438|B1|Baseline|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
507201|NCT00737438|P1|Participant Flow|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
507202|NCT00737438|O1|Outcome|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
507203|NCT00737438|E1|Reported Event|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
507204|NCT00737360|B1|Baseline|TAS-106|
507205|NCT00737360|P1|Participant Flow|TAS-106|
507206|NCT00737360|O1|Outcome|TAS-106|
507207|NCT00737360|O1|Outcome|TAS-106|
507208|NCT00737360|O1|Outcome|TAS-106|
507209|NCT00737360|O1|Outcome|TAS-106|
507210|NCT00737360|E1|Reported Event|TAS-106|
507211|NCT00737282|B3|Baseline|Total|Total of all reporting groups
507212|NCT00737282|B2|Baseline|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
507213|NCT00737282|B1|Baseline|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
507214|NCT00737282|P1|Participant Flow|Proellex|"Proellex 25 or 50 mg once daily~One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
507215|NCT00737282|O2|Outcome|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
507216|NCT00737282|O1|Outcome|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
507217|NCT00737282|E2|Reported Event|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
507218|NCT00737282|E1|Reported Event|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
507219|NCT00737243|B1|Baseline|Patients With Tumor Assays Performed|Of 289 patients initially enrolled, 252 had successful assays performed. 37 patients had insufficient tissue for assay and came off study.
507220|NCT00737243|P1|Participant Flow|All Patients With a Successful Tumor Assays Performed|Subjects in this group had a successful molecular assay of biopsy tissue
507221|NCT00737243|O1|Outcome|Patients With Successful Tumor Assays Performed|In 252 participants successful assays were performed. In 29 participants the amount of tumour and/or viable RNA present in the biopsy specimen was inadequate.
507222|NCT00737243|O2|Outcome|Less Treatment Responsive|Patients who received assay-directed therapy for tumors with a predicted median survival ≤ 12 months
507223|NCT00737243|O1|Outcome|More Treatment Responsive|Patients who received assay-directed therapy for tumor types with a predicted median survival ≥ 12 months.
507224|NCT00737243|E1|Reported Event|All Treated Patients|
507225|NCT00737204|B3|Baseline|Total|Total of all reporting groups
507226|NCT00737204|B2|Baseline|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
507227|NCT00737204|B1|Baseline|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
507228|NCT00737204|P2|Participant Flow|Placebo|Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.
507229|NCT00737204|P1|Participant Flow|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.
507230|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
507231|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
507232|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
507233|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
507234|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
507235|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
507236|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
507237|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
507238|NCT00737204|E2|Reported Event|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
507239|NCT00737204|E1|Reported Event|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
507240|NCT00737178|B3|Baseline|Total|Total of all reporting groups
507241|NCT00737178|B2|Baseline|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
507242|NCT00737178|B1|Baseline|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
507243|NCT00737178|P2|Participant Flow|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
507244|NCT00737178|P1|Participant Flow|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
507245|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
507246|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
507247|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
507248|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
507249|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
507250|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
507251|NCT00737178|E2|Reported Event|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
507252|NCT00737178|E1|Reported Event|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
507253|NCT00737100|B4|Baseline|Total|Total of all reporting groups
507254|NCT00737100|B3|Baseline|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507255|NCT00737100|B2|Baseline|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507256|NCT00737100|B1|Baseline|Placebo|Patients randomised to receive matching placebo
507257|NCT00737100|P3|Participant Flow|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507258|NCT00737100|P2|Participant Flow|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507259|NCT00737100|P1|Participant Flow|Placebo|Patients randomised to receive matching placebo
507260|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507261|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507262|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507263|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507264|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507265|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507266|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507267|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507268|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
526179|NCT00699608|O1|Outcome|Placebo|Placebo
507269|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507270|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507271|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507272|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507273|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507274|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507275|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507276|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507277|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507278|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507279|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507280|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507281|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507282|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507283|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507284|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507285|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507286|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507287|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507288|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507289|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507290|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507291|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507292|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507293|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507294|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507295|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507296|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507297|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507298|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
507299|NCT00737100|E3|Reported Event|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
507300|NCT00737100|E2|Reported Event|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
507301|NCT00737100|E1|Reported Event|Placebo|Patients randomised to receive matching placebo
507302|NCT00737061|B1|Baseline|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507303|NCT00737061|P1|Participant Flow|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507304|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507305|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507306|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507307|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507308|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507309|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507310|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507311|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507312|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507313|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507314|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507315|NCT00737061|E1|Reported Event|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
507316|NCT00737048|B4|Baseline|Total|Total of all reporting groups
507317|NCT00737048|B3|Baseline|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507318|NCT00737048|B2|Baseline|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507319|NCT00737048|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507320|NCT00737048|P3|Participant Flow|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507321|NCT00737048|P2|Participant Flow|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507322|NCT00737048|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507323|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507324|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507325|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507326|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507327|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507328|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507329|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507330|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507331|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507332|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507333|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507334|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507335|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507452|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507336|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507337|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507338|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507339|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507340|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507341|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507342|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507343|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507344|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507345|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507346|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507347|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507348|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507349|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507350|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507351|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507352|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507453|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507353|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507354|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507355|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507356|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507357|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507358|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507359|NCT00737048|E3|Reported Event|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507360|NCT00737048|E2|Reported Event|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507361|NCT00737048|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
507362|NCT00736996|B4|Baseline|Total|Total of all reporting groups
507363|NCT00736996|B3|Baseline|Placebo|Placebo: Matching oral tablet daily for 6 months
507364|NCT00736996|B2|Baseline|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
507365|NCT00736996|B1|Baseline|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
507366|NCT00736996|P3|Participant Flow|Placebo|Placebo: Matching oral tablet daily for 6 months
507367|NCT00736996|P2|Participant Flow|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
507368|NCT00736996|P1|Participant Flow|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
507369|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
507370|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
507371|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
507372|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
507373|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
507374|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
507375|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
507376|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
507377|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
507378|NCT00736996|E3|Reported Event|Placebo|Placebo: Matching oral tablet daily for 6 months
507379|NCT00736996|E2|Reported Event|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
507380|NCT00736996|E1|Reported Event|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
507456|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507381|NCT00736957|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507382|NCT00736957|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507383|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507384|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507385|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507386|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507387|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507388|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507389|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507390|NCT00736957|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
507391|NCT00736944|B1|Baseline|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507392|NCT00736944|P1|Participant Flow|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507393|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507394|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507454|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507455|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507395|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507396|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507397|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507398|NCT00736944|O3|Outcome|FDG-PET/CT|
507399|NCT00736944|O2|Outcome|CT Scan|
507400|NCT00736944|O1|Outcome|Clinical Examination|
507401|NCT00736944|O3|Outcome|FDG-PET/CT|
507402|NCT00736944|O2|Outcome|CT Scan|
507403|NCT00736944|O1|Outcome|Clinical Examination|
507404|NCT00736944|O3|Outcome|FDG-PET/CT|
507405|NCT00736944|O2|Outcome|CT Scan|
507406|NCT00736944|O1|Outcome|Clinical Examination|
507407|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507408|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507409|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507410|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507411|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507412|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507413|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507414|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507415|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507416|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507417|NCT00736944|E1|Reported Event|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
507418|NCT00736879|B5|Baseline|Total|Total of all reporting groups
507419|NCT00736879|B4|Baseline|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507420|NCT00736879|B3|Baseline|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507421|NCT00736879|B2|Baseline|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507422|NCT00736879|B1|Baseline|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507423|NCT00736879|P4|Participant Flow|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507424|NCT00736879|P3|Participant Flow|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507425|NCT00736879|P2|Participant Flow|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507426|NCT00736879|P1|Participant Flow|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507427|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507428|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507429|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507430|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507431|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507432|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507433|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507434|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507435|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507436|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507437|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507438|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507439|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507440|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507441|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507442|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507443|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507444|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507445|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507446|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507447|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507448|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507449|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507450|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507451|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507608|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507457|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507458|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507459|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507460|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507461|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507462|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507463|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507464|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507465|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507466|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507467|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507468|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507469|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507470|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507471|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507472|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507473|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507474|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507475|NCT00736879|E4|Reported Event|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507476|NCT00736879|E3|Reported Event|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507477|NCT00736879|E2|Reported Event|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507478|NCT00736879|E1|Reported Event|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
507479|NCT00736853|B1|Baseline|Entire Study Population|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period.
507480|NCT00736853|P3|Participant Flow|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507481|NCT00736853|P2|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507482|NCT00736853|P1|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507483|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507484|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507485|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507486|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507487|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507488|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507489|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507490|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507491|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507492|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507493|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507494|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507495|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507496|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507497|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507498|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507499|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507500|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507501|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507502|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507503|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507504|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507505|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507506|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507507|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507508|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507509|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507510|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507511|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507512|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507513|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507514|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507515|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507516|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
507517|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507518|NCT00736853|E3|Reported Event|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
526180|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
507519|NCT00736853|E2|Reported Event|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
507520|NCT00736853|E1|Reported Event|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
507521|NCT00736840|B1|Baseline|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
507522|NCT00736840|P1|Participant Flow|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
507523|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
507524|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
507525|NCT00736840|E1|Reported Event|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
507526|NCT00736723|B3|Baseline|Total|Total of all reporting groups
507527|NCT00736723|B2|Baseline|Postoperative/Posttraumatic Patients With Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
507528|NCT00736723|B1|Baseline|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
507529|NCT00736723|P2|Participant Flow|Patients With Septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
507530|NCT00736723|P1|Participant Flow|Patients With Non-septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing non-septic shock
507531|NCT00736723|O2|Outcome|Patients Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
507532|NCT00736723|O1|Outcome|Patients Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
507533|NCT00736723|E2|Reported Event|Postoperative/Posttraumatic Patients With Septi|Postoperative/posttraumatic critically ill patients with septic shock
507534|NCT00736723|E1|Reported Event|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
507535|NCT00736645|B5|Baseline|Total|Total of all reporting groups
507536|NCT00736645|B4|Baseline|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
507537|NCT00736645|B3|Baseline|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
507538|NCT00736645|B2|Baseline|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
507539|NCT00736645|B1|Baseline|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
507540|NCT00736645|P4|Participant Flow|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
507541|NCT00736645|P3|Participant Flow|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
507542|NCT00736645|P2|Participant Flow|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
507543|NCT00736645|P1|Participant Flow|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
507544|NCT00736645|O4|Outcome|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
507545|NCT00736645|O3|Outcome|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
507546|NCT00736645|O2|Outcome|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
507547|NCT00736645|O1|Outcome|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
507548|NCT00736645|O4|Outcome|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
507549|NCT00736645|O3|Outcome|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
507550|NCT00736645|O2|Outcome|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
507609|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507551|NCT00736645|O1|Outcome|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
507552|NCT00736645|E4|Reported Event|Arm D: Finasteride Placebo + Selenium|"Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.~Selenomethionine: Given orally~Placebo: Given orally"
507553|NCT00736645|E3|Reported Event|Arm C: Finasteride Placebo + Selenium Placebo|"Patients receive two oral placebos once daily for 4-5 weeks.~Placebo: Given orally"
507554|NCT00736645|E2|Reported Event|Arm B: Finasteride + Selenium|"Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.~Selenomethionine: Given orally~Finasteride: Given orally"
507555|NCT00736645|E1|Reported Event|Arm A: Finasteride + Selenium Placebo|"Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.~Finasteride: Given orally~Placebo: Given orally"
507556|NCT00736580|B3|Baseline|Total|Total of all reporting groups
507557|NCT00736580|B2|Baseline|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
507558|NCT00736580|B1|Baseline|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
507559|NCT00736580|P2|Participant Flow|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
507560|NCT00736580|P1|Participant Flow|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
507561|NCT00736580|O2|Outcome|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
507562|NCT00736580|O1|Outcome|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
507563|NCT00736580|E2|Reported Event|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
507564|NCT00736580|E1|Reported Event|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
507565|NCT00736502|B1|Baseline|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
507566|NCT00736502|P1|Participant Flow|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
507567|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
507568|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
507569|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
507570|NCT00736502|E1|Reported Event|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
507571|NCT00736489|B1|Baseline|Baseline Total|Total number of patients randomized and treated in the study
507572|NCT00736489|P6|Participant Flow|PEBCDAa|Placebo followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg.
507573|NCT00736489|P5|Participant Flow|EDABCPa|Formoterol 36 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Placebo.
507574|NCT00736489|P4|Participant Flow|DCPABEa|Formoterol 9 Mcg followed by AZD3199 1920 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg.
507575|NCT00736489|P3|Participant Flow|CBEPADa|AZD3199 1920 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg .
507576|NCT00736489|P2|Participant Flow|BADEPCa|AZD3199 480 Mcg followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 1920 Mcg.
507577|NCT00736489|P1|Participant Flow|APCDEBa|AZD3199 120 Mcg followed by Placebo followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg.
507578|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507579|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507580|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507581|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507582|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507583|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507584|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507585|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507586|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507587|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507588|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507589|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507590|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507591|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507592|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507593|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507594|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507595|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507596|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507597|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507598|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507599|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507600|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507601|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507602|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507603|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507604|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507605|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507606|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507607|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507628|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507629|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507630|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507631|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507632|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507633|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507634|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507635|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507636|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507637|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507638|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507639|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507640|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507641|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507642|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507643|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507644|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507645|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507646|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507647|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507648|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507649|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507650|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507651|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507652|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507653|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507654|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507655|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507656|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507657|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507658|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507659|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507660|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507661|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507662|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507663|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507664|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507665|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507666|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507667|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507668|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507669|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507670|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507671|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507672|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507673|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507674|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507675|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507676|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507677|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507678|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507679|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507680|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507681|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507682|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507683|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507684|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507685|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507686|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507687|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507688|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507689|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507690|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507691|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507692|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507693|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507694|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507695|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507696|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507697|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507698|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507699|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507700|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507701|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507702|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507703|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507704|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507705|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507706|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507707|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507708|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507709|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507710|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507711|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507712|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507713|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507714|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507715|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507716|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
507717|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507718|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507719|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507720|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507721|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507722|NCT00736489|E6|Reported Event|Placebo|Placebo inhaled via Turbuhaler
507723|NCT00736489|E5|Reported Event|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
507724|NCT00736489|E4|Reported Event|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
507725|NCT00736489|E3|Reported Event|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
507726|NCT00736489|E2|Reported Event|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
507727|NCT00736489|E1|Reported Event|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
507728|NCT00736476|B3|Baseline|Total|Total of all reporting groups
507729|NCT00736476|B2|Baseline|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
507730|NCT00736476|B1|Baseline|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
507731|NCT00736476|P2|Participant Flow|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months,followed by H.pylori challenge (oral administration of infectious HP inoculum)1 month later.
507732|NCT00736476|P1|Participant Flow|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months, followed by H.pylori challenge(oral administration of infectious HP inoculum)1 month later.
507733|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507734|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507735|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507736|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507737|NCT00736476|O4|Outcome|Group II (Placebo) Non-Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507738|NCT00736476|O3|Outcome|Group II (Placebo) Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507739|NCT00736476|O2|Outcome|Group I (HP Vaccine) Non-Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507740|NCT00736476|O1|Outcome|Group I (HP Vaccine) Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507741|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507742|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507743|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507744|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
507745|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507746|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507747|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507748|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
507749|NCT00736476|E2|Reported Event|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
507750|NCT00736476|E1|Reported Event|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
507751|NCT00736385|B3|Baseline|Total|Total of all reporting groups
507752|NCT00736385|B2|Baseline|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
507753|NCT00736385|B1|Baseline|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
507754|NCT00736385|P2|Participant Flow|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
507755|NCT00736385|P1|Participant Flow|Metformin|"Metformin XR (extended-release) 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
507756|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
507757|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
507758|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
507759|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
507760|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
507761|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
507762|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
507763|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
507764|NCT00736385|E2|Reported Event|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
507765|NCT00736385|E1|Reported Event|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
507766|NCT00736333|B1|Baseline|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507767|NCT00736333|P1|Participant Flow|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507768|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507769|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507770|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507771|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507772|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507773|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507774|NCT00736333|E1|Reported Event|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
507775|NCT00736255|B3|Baseline|Total|Total of all reporting groups
507776|NCT00736255|B2|Baseline|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
507777|NCT00736255|B1|Baseline|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
507778|NCT00736255|P2|Participant Flow|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
507779|NCT00736255|P1|Participant Flow|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
507780|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
507781|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
507782|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
507783|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
507784|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
507785|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
507786|NCT00736255|E2|Reported Event|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
507787|NCT00736255|E1|Reported Event|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
507788|NCT00736242|B1|Baseline|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507857|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507858|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507789|NCT00736242|P1|Participant Flow|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507790|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507791|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507792|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507793|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507794|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507795|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507796|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507797|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507798|NCT00736242|E1|Reported Event|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
507799|NCT00736229|B4|Baseline|Total|Total of all reporting groups
507800|NCT00736229|B3|Baseline|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
507801|NCT00736229|B2|Baseline|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
507802|NCT00736229|B1|Baseline|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
507803|NCT00736229|P3|Participant Flow|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
507804|NCT00736229|P2|Participant Flow|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
507805|NCT00736229|P1|Participant Flow|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
507806|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
507807|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
507808|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
507809|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
507810|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
526181|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
507811|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
507812|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
507813|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
507814|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
507815|NCT00736229|O1|Outcome|Exenatide|Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.
507816|NCT00736229|E1|Reported Event|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
507817|NCT00736190|B1|Baseline|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
507818|NCT00736190|P1|Participant Flow|A: TDF|Tenofovir disoproxil fumarate (TDF) 300 mg by mouth daily
507819|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507820|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507821|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507822|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507823|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507824|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507825|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507826|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507827|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507828|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
507829|NCT00736190|E1|Reported Event|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
507830|NCT00736125|B3|Baseline|Total|Total of all reporting groups
507831|NCT00736125|B2|Baseline|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
507832|NCT00736125|B1|Baseline|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
507833|NCT00736125|P2|Participant Flow|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
507834|NCT00736125|P1|Participant Flow|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
507835|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
507836|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
507837|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
507838|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
507839|NCT00736125|E2|Reported Event|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
507840|NCT00736125|E1|Reported Event|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
507841|NCT00736099|B3|Baseline|Total|Total of all reporting groups
507842|NCT00736099|B2|Baseline|New Lina|Patients pre-treated with placebo
507843|NCT00736099|B1|Baseline|Old Lina|Patients pre-treated with linagliptin
507844|NCT00736099|P2|Participant Flow|New Lina|Patients pre-treated with placebo
507845|NCT00736099|P1|Participant Flow|Old Lina|Patients pre-treated with linagliptin (BI 1356)
507846|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507847|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507848|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507849|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507850|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507851|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507852|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507853|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507854|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507855|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507859|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507860|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507861|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507862|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507863|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507864|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507865|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507866|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507867|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507868|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507869|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507870|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507871|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507872|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507873|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507874|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507875|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507876|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507877|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507878|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507879|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507880|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507881|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507882|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507883|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507884|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507885|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507886|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507887|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507888|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507889|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507890|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507891|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507892|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507893|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507894|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507895|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507896|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507897|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507898|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507899|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507900|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507901|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507902|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507903|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507904|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507905|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507906|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507907|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507908|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507909|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507910|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507911|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507912|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507913|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507914|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507915|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507916|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507917|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507918|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507919|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507920|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507921|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507922|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507923|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507924|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507925|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507926|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507927|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507928|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507929|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507930|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507931|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507932|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507933|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507934|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507935|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507936|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
507937|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
507938|NCT00736099|E2|Reported Event|New Lina|Patients pre-treated with placebo
507939|NCT00736099|E1|Reported Event|Old Lina|Patients pre-treated with linagliptin
507940|NCT00736073|B3|Baseline|Total|Total of all reporting groups
507941|NCT00736073|B2|Baseline|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507942|NCT00736073|B1|Baseline|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507943|NCT00736073|P2|Participant Flow|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507944|NCT00736073|P1|Participant Flow|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507945|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507946|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507947|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507948|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507949|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507950|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507951|NCT00736073|E2|Reported Event|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507952|NCT00736073|E1|Reported Event|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
507953|NCT00736034|B1|Baseline|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
507954|NCT00736034|P1|Participant Flow|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
507955|NCT00736034|O1|Outcome|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
507956|NCT00736034|E1|Reported Event|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
507957|NCT00735969|B1|Baseline|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
507958|NCT00735969|P1|Participant Flow|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and assigned to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
507959|NCT00735969|O1|Outcome|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
507960|NCT00735969|E1|Reported Event|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
507961|NCT00735943|B1|Baseline|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507962|NCT00735943|P1|Participant Flow|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507963|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507964|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507965|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507966|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507967|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507968|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507969|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507970|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507971|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507972|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
508003|NCT00735839|E1|Reported Event|V710|V710 vaccination (60 mcg) single dose on Day 1
507973|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507974|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507975|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507976|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507977|NCT00735943|E1|Reported Event|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
507978|NCT00735917|B1|Baseline|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507979|NCT00735917|P1|Participant Flow|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507980|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507981|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507982|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507983|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507984|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507985|NCT00735917|E1|Reported Event|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
507986|NCT00735904|B1|Baseline|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
507987|NCT00735904|P1|Participant Flow|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
507988|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
507989|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
507990|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
507991|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
507992|NCT00735904|E1|Reported Event|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
507993|NCT00735839|B3|Baseline|Total|Total of all reporting groups
507994|NCT00735839|B2|Baseline|Placebo|Placebo single dose on Day 1
507995|NCT00735839|B1|Baseline|V710|V710 vaccination (60 mcg) single dose on Day 1
507996|NCT00735839|P2|Participant Flow|Placebo|Placebo single dose on Day 1
507997|NCT00735839|P1|Participant Flow|V710|V710 vaccination (60 mcg) single dose on Day 1
507998|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
507999|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
508000|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
508001|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
508002|NCT00735839|E2|Reported Event|Placebo|Placebo single dose on Day 1
508005|NCT00735787|B2|Baseline|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508006|NCT00735787|B1|Baseline|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508007|NCT00735787|P2|Participant Flow|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508008|NCT00735787|P1|Participant Flow|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508009|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508010|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508011|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508012|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508013|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508014|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508015|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508016|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508017|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508018|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508019|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508020|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508021|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508022|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508023|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508024|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508025|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508026|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508027|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508028|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508029|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508030|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508031|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508032|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508033|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508073|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508521|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
508034|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508035|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508036|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508037|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508038|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508039|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508040|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508041|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508042|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508043|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508044|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508045|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508046|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508047|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508048|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508049|NCT00735787|E2|Reported Event|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
508050|NCT00735787|E1|Reported Event|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
508051|NCT00735709|B5|Baseline|Total|Total of all reporting groups
508052|NCT00735709|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508053|NCT00735709|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508054|NCT00735709|B2|Baseline|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508055|NCT00735709|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508056|NCT00735709|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508057|NCT00735709|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508058|NCT00735709|P2|Participant Flow|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508059|NCT00735709|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508060|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508061|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508062|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508063|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508064|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508065|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508066|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508067|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508068|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508069|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508070|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508071|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508072|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508571|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508074|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508075|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508076|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508077|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508078|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508079|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508080|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508081|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508082|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508083|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508084|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508085|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508086|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508087|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508088|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508089|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508090|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508091|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508092|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508093|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508094|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508095|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508096|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508097|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508098|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508099|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508100|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508101|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508102|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508103|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508104|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508105|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508106|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508107|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508108|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508109|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508110|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508111|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508112|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508113|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508114|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508115|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508116|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508117|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508118|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508119|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508120|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508121|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508122|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508123|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508124|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508125|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508126|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508127|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508128|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508129|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508130|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508131|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508132|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508133|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508134|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508135|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508136|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508137|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508138|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508139|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508140|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508141|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508142|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508143|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508144|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508145|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508146|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508147|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508148|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508149|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508150|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508151|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508152|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508153|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508154|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508155|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508156|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508157|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508158|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508159|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508160|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508161|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508162|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508163|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508164|NCT00735709|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508165|NCT00735709|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508166|NCT00735709|E2|Reported Event|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
508167|NCT00735709|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
508168|NCT00735696|B1|Baseline|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks."
508169|NCT00735696|P1|Participant Flow|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508204|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
508170|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508171|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508172|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508173|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508174|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508175|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508176|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508177|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508178|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508205|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508206|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
508207|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
508572|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508179|NCT00735696|E1|Reported Event|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
508180|NCT00735670|B3|Baseline|Total|Total of all reporting groups
508181|NCT00735670|B2|Baseline|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
508182|NCT00735670|B1|Baseline|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
508183|NCT00735670|P2|Participant Flow|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
508184|NCT00735670|P1|Participant Flow|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
508185|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
508186|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
508187|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
508188|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
508189|NCT00735670|E2|Reported Event|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
508190|NCT00735670|E1|Reported Event|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
508191|NCT00735644|B6|Baseline|Total|Total of all reporting groups
508192|NCT00735644|B5|Baseline|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
508193|NCT00735644|B4|Baseline|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508194|NCT00735644|B3|Baseline|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
508195|NCT00735644|B2|Baseline|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508196|NCT00735644|B1|Baseline|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
508197|NCT00735644|P5|Participant Flow|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis A vaccine
508198|NCT00735644|P4|Participant Flow|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508199|NCT00735644|P3|Participant Flow|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3
508200|NCT00735644|P2|Participant Flow|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508201|NCT00735644|P1|Participant Flow|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
508202|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
508203|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508208|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508209|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
508210|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508211|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
508212|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly
508213|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously
508214|NCT00735644|O3|Outcome|JE-CV MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously
508215|NCT00735644|O2|Outcome|JE-CV MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously
508216|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
508217|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
508218|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508219|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
508220|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508221|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
508222|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
508223|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508224|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
508225|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508226|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
508227|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
508228|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508229|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
508230|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508231|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
508232|NCT00735644|E5|Reported Event|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
508233|NCT00735644|E4|Reported Event|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
508234|NCT00735644|E3|Reported Event|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
508235|NCT00735644|E2|Reported Event|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
508236|NCT00735644|E1|Reported Event|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
508237|NCT00735618|B1|Baseline|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
508238|NCT00735618|P1|Participant Flow|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
508239|NCT00735618|O1|Outcome|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program and summed ESAS scores
508240|NCT00735618|E1|Reported Event|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
508241|NCT00735553|B4|Baseline|Total|Total of all reporting groups
508242|NCT00735553|B3|Baseline|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
508243|NCT00735553|B2|Baseline|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
508244|NCT00735553|B1|Baseline|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
508245|NCT00735553|P1|Participant Flow|All Groups|25 mg, 50 mg oral daily dose of Proellex or placebo
508246|NCT00735553|O3|Outcome|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
508247|NCT00735553|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
508248|NCT00735553|O1|Outcome|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
508249|NCT00735553|E3|Reported Event|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
508330|NCT00735371|P4|Participant Flow|Placebo|Placebo
508250|NCT00735553|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
508251|NCT00735553|E1|Reported Event|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
508252|NCT00735475|B3|Baseline|Total|Total of all reporting groups
508253|NCT00735475|B2|Baseline|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508254|NCT00735475|B1|Baseline|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508255|NCT00735475|P2|Participant Flow|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508256|NCT00735475|P1|Participant Flow|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508257|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508258|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508259|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508260|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508261|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508262|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508263|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508264|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508265|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508266|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508267|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508268|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508269|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508270|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508271|NCT00735475|E2|Reported Event|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
508272|NCT00735475|E1|Reported Event|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
508273|NCT00735462|B4|Baseline|Total|Total of all reporting groups
508274|NCT00735462|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
508275|NCT00735462|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508276|NCT00735462|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508277|NCT00735462|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
508278|NCT00735462|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508279|NCT00735462|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508280|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
508281|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508282|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508283|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
508284|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508285|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508286|NCT00735462|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
508287|NCT00735462|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508288|NCT00735462|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
508289|NCT00735449|B3|Baseline|Total|Total of all reporting groups
508290|NCT00735449|B2|Baseline|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508291|NCT00735449|B1|Baseline|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508292|NCT00735449|P2|Participant Flow|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508293|NCT00735449|P1|Participant Flow|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508294|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508295|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508296|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508297|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508298|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508403|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508299|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508300|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508301|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508302|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508303|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508304|NCT00735449|E2|Reported Event|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
508305|NCT00735449|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
508306|NCT00735436|B1|Baseline|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
508307|NCT00735436|P1|Participant Flow|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an enzyme-inducing anti-epileptic drugs (EIAED), the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
508308|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
508309|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
508310|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
508311|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
508312|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
508313|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
508314|NCT00735436|E1|Reported Event|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
508315|NCT00735397|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508316|NCT00735397|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508317|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508318|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508319|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508320|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508321|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508322|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508323|NCT00735397|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508324|NCT00735397|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
508325|NCT00735371|B5|Baseline|Total|Total of all reporting groups
508326|NCT00735371|B4|Baseline|Placebo|Placebo
508327|NCT00735371|B3|Baseline|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508328|NCT00735371|B2|Baseline|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508329|NCT00735371|B1|Baseline|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508331|NCT00735371|P3|Participant Flow|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508332|NCT00735371|P2|Participant Flow|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508333|NCT00735371|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508334|NCT00735371|O4|Outcome|Placebo|Placebo
508335|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508336|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508337|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508338|NCT00735371|O4|Outcome|Placebo|Placebo
508339|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508340|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508341|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508342|NCT00735371|O4|Outcome|Placebo|Placebo
508343|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508344|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508345|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508346|NCT00735371|E4|Reported Event|Placebo|Placebo
508347|NCT00735371|E3|Reported Event|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508348|NCT00735371|E2|Reported Event|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508349|NCT00735371|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
508350|NCT00735306|B1|Baseline|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
508351|NCT00735306|P1|Participant Flow|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
508352|NCT00735306|O1|Outcome|Single Arm Avastin, Tarceva and Radiation Therapy|"Avastin, Tarceva and Radiation Therapy~Avastin: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy~Tarceva: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy~Radiation Therapy: Radiation to the pancreas Monday through Friday for 28 treatments"
508353|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
508354|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
508355|NCT00735306|E1|Reported Event|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
508356|NCT00735254|B5|Baseline|Total|Total of all reporting groups
508357|NCT00735254|B4|Baseline|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
508358|NCT00735254|B3|Baseline|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
508359|NCT00735254|B2|Baseline|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
508360|NCT00735254|B1|Baseline|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
508361|NCT00735254|P4|Participant Flow|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
508404|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508362|NCT00735254|P3|Participant Flow|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
508363|NCT00735254|P2|Participant Flow|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
508364|NCT00735254|P1|Participant Flow|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
508365|NCT00735254|O4|Outcome|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
508366|NCT00735254|O3|Outcome|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
508367|NCT00735254|O2|Outcome|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
508368|NCT00735254|O1|Outcome|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
508369|NCT00735254|E4|Reported Event|Placebo|"Patient will be have scar treated with Placebo~Placebo: patient will receive no treatment"
508370|NCT00735254|E3|Reported Event|Combined PDL and Affirm Lasers|"Patient will be have scar treated with combined Affirm + PDL~combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers"
508371|NCT00735254|E2|Reported Event|Affirm Laser|"Patient will be have scar treated with Affirm Laser~Affirm Laser: patient will have scar treated with Affirm laser"
508372|NCT00735254|E1|Reported Event|Pulsed Dye Laser|"PDL Patient will be have scar treated with pulsed dye laser.~pulsed dye laser: patient will have scar treated with pulsed dye laser"
508373|NCT00735072|B3|Baseline|Total|Total of all reporting groups
508374|NCT00735072|B2|Baseline|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508375|NCT00735072|B1|Baseline|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508376|NCT00735072|P2|Participant Flow|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508377|NCT00735072|P1|Participant Flow|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508378|NCT00735072|O2|Outcome|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508379|NCT00735072|O1|Outcome|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508380|NCT00735072|E2|Reported Event|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508381|NCT00735072|E1|Reported Event|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
508382|NCT00735007|B1|Baseline|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508383|NCT00735007|P1|Participant Flow|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508384|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508385|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508386|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508387|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508388|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508389|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508390|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508391|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508392|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508393|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508394|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508395|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508396|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508397|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508398|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508399|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508400|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508401|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508402|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508405|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508406|NCT00735007|E1|Reported Event|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
508407|NCT00734994|B1|Baseline|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
508408|NCT00734994|P1|Participant Flow|Mitomycin C With Hyperthermia and Recurrent Bladder Cancer|Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
508409|NCT00734994|O1|Outcome|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
508410|NCT00734994|O1|Outcome|Hyperthermia System, Mitomycin C|"Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.~Hyperthermia System: Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence~Mitomycin C: 40 mg in 40 ml sterile water instilled into bladder"
508411|NCT00734994|E1|Reported Event|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
508412|NCT00734968|B3|Baseline|Total|Total of all reporting groups
508413|NCT00734968|B2|Baseline|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
508414|NCT00734968|B1|Baseline|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
508415|NCT00734968|P2|Participant Flow|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
508416|NCT00734968|P1|Participant Flow|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO twice a day (BID) x 3 days post-operatively. The incidence of urinary tract infection (UTI) in this group will be compared with group one (1).~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100 mg tablets."
508417|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
508418|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
508419|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
508420|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
508421|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
508422|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
508423|NCT00734968|E2|Reported Event|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
508424|NCT00734968|E1|Reported Event|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
508425|NCT00734929|B3|Baseline|Total|Total of all reporting groups
508426|NCT00734929|B2|Baseline|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508427|NCT00734929|B1|Baseline|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508428|NCT00734929|P2|Participant Flow|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508429|NCT00734929|P1|Participant Flow|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508430|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508431|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508432|NCT00734929|O2|Outcome|Ondansetron + Dexamethasone|"Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia~Ondansetron + Dexamethasone: Ondansetron 4 mg + Dexamethasone 10 mg"
508433|NCT00734929|O1|Outcome|Aprepitant + Dexamethasone|"Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia~Aprepitant + Dexamethasone: Aprepitant 40 mg + Dexamethasone 10 mg"
508434|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508435|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508436|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508437|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508438|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508439|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508440|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508441|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508442|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508443|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508444|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508445|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508446|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508447|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508448|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508449|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508450|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508451|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508452|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508453|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508454|NCT00734929|E2|Reported Event|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
508455|NCT00734929|E1|Reported Event|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
508456|NCT00734851|B1|Baseline|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508457|NCT00734851|P1|Participant Flow|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508458|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508459|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508460|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508461|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508462|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508463|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508464|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508465|NCT00734851|E1|Reported Event|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
508466|NCT00734799|B3|Baseline|Total|Total of all reporting groups
508467|NCT00734799|B2|Baseline|Intervention|Sleep Intervention for PTSD (SIP)
508468|NCT00734799|B1|Baseline|Wait List|Usual Care/Wait-List Control
508469|NCT00734799|P2|Participant Flow|Intervention|Sleep Intervention for PTSD (SIP)
508470|NCT00734799|P1|Participant Flow|Wait List|Usual Care/Wait-List Control
508471|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
508472|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
508473|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
508474|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
508475|NCT00734799|E2|Reported Event|Intervention|Sleep Intervention for PTSD (SIP)
508476|NCT00734799|E1|Reported Event|Wait List|Usual Care/Wait-List Control
508477|NCT00734747|B1|Baseline|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
508478|NCT00734747|P1|Participant Flow|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~Medigus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
508479|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
508480|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
508481|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
508482|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
508483|NCT00734747|E1|Reported Event|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
508484|NCT00734734|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
508485|NCT00734734|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
508486|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
508487|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
508488|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
508489|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
508490|NCT00734734|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
508491|NCT00734656|B1|Baseline|All Study Participants|All study participants enrolled in Lab Session 1
508492|NCT00734656|P4|Participant Flow|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
508493|NCT00734656|P3|Participant Flow|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
508494|NCT00734656|P2|Participant Flow|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
508495|NCT00734656|P1|Participant Flow|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
508496|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
508497|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
508498|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
508499|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
508500|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
508501|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
508502|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
508503|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
508504|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
508505|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
508506|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
508507|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
508508|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
508509|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
508510|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
508511|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
508512|NCT00734656|E4|Reported Event|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
508513|NCT00734656|E3|Reported Event|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
508514|NCT00734656|E2|Reported Event|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
508515|NCT00734656|E1|Reported Event|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
508516|NCT00734630|B3|Baseline|Total|Total of all reporting groups
508517|NCT00734630|B2|Baseline|Placebo|Matching placebo tablets, oral administration
508518|NCT00734630|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
508519|NCT00734630|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
508520|NCT00734630|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
508522|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
508523|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
508524|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
508525|NCT00734630|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
508526|NCT00734630|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
508527|NCT00734617|B3|Baseline|Total|Total of all reporting groups
508528|NCT00734617|B2|Baseline|More Dependent|
508529|NCT00734617|B1|Baseline|Less Dependent|
508530|NCT00734617|P2|Participant Flow|More Dependent|
508531|NCT00734617|P1|Participant Flow|Less Dependent|
508532|NCT00734617|O2|Outcome|More Dependent|
508533|NCT00734617|O1|Outcome|Less Dependent|
508534|NCT00734617|E2|Reported Event|More Dependent|
508535|NCT00734617|E1|Reported Event|Less Dependent|
508536|NCT00734604|B7|Baseline|Total|Total of all reporting groups
508537|NCT00734604|B6|Baseline|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
508538|NCT00734604|B5|Baseline|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
508539|NCT00734604|B4|Baseline|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
508540|NCT00734604|B3|Baseline|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
508541|NCT00734604|B2|Baseline|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
508542|NCT00734604|B1|Baseline|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
508543|NCT00734604|P6|Participant Flow|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
508544|NCT00734604|P5|Participant Flow|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
508545|NCT00734604|P4|Participant Flow|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
508546|NCT00734604|P3|Participant Flow|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
508547|NCT00734604|P2|Participant Flow|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
508548|NCT00734604|P1|Participant Flow|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
508549|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508550|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508551|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508552|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508553|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508554|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508555|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508556|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508557|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508558|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508559|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508560|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508561|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508562|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508563|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508564|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508565|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508566|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508567|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508568|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508569|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508570|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508573|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508574|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508575|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508576|NCT00734604|O3|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508577|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|tadalafil 20 mg as needed [T(PRN)]
508578|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508579|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508580|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508581|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508582|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508583|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508584|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508585|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508586|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508587|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508588|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508589|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508590|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508591|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508592|NCT00734604|E3|Reported Event|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
508593|NCT00734604|E2|Reported Event|Sildenafil Citrate as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
508594|NCT00734604|E1|Reported Event|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
508595|NCT00734591|B3|Baseline|Total|Total of all reporting groups
508596|NCT00734591|B2|Baseline|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508597|NCT00734591|B1|Baseline|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508598|NCT00734591|P2|Participant Flow|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508599|NCT00734591|P1|Participant Flow|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508600|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508601|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508602|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508603|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508604|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508605|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508606|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508607|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508953|NCT00734305|B1|Baseline|MM-121 Dose Escalation|MM-121: Dose escalation Frequency - once weekly IV
508608|NCT00734591|E2|Reported Event|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508609|NCT00734591|E1|Reported Event|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
508610|NCT00734578|B4|Baseline|Total|Total of all reporting groups
508611|NCT00734578|B3|Baseline|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508612|NCT00734578|B2|Baseline|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508613|NCT00734578|B1|Baseline|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508614|NCT00734578|P3|Participant Flow|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508615|NCT00734578|P2|Participant Flow|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508616|NCT00734578|P1|Participant Flow|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508617|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508618|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508619|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508620|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508621|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508622|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508623|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508624|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508625|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508626|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508679|NCT00734500|P1|Participant Flow|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
508680|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
508627|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508628|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508629|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508630|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508631|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508632|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508633|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508634|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508635|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508636|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508637|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508638|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508639|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508640|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508641|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508642|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508643|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508644|NCT00734578|E3|Reported Event|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
508681|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
508682|NCT00734500|E1|Reported Event|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
508645|NCT00734578|E2|Reported Event|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508646|NCT00734578|E1|Reported Event|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
508647|NCT00734539|B3|Baseline|Total|Total of all reporting groups
508648|NCT00734539|B2|Baseline|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508649|NCT00734539|B1|Baseline|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508650|NCT00734539|P2|Participant Flow|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508651|NCT00734539|P1|Participant Flow|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508652|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses"
508653|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
508654|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly for a total of up to 12-13 doses"
508655|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
508656|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508657|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508658|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508659|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508660|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508661|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508662|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508663|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508664|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508665|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508666|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508667|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508668|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508669|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508670|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508671|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508672|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508673|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508674|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508675|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508676|NCT00734539|E2|Reported Event|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
508677|NCT00734539|E1|Reported Event|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
508678|NCT00734500|B1|Baseline|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
508684|NCT00734474|B9|Baseline|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508685|NCT00734474|B8|Baseline|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508686|NCT00734474|B7|Baseline|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508687|NCT00734474|B6|Baseline|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508688|NCT00734474|B5|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508689|NCT00734474|B4|Baseline|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508690|NCT00734474|B3|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508691|NCT00734474|B2|Baseline|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508692|NCT00734474|B1|Baseline|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508693|NCT00734474|P9|Participant Flow|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508694|NCT00734474|P8|Participant Flow|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508695|NCT00734474|P7|Participant Flow|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508696|NCT00734474|P6|Participant Flow|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508697|NCT00734474|P5|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508698|NCT00734474|P4|Participant Flow|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508699|NCT00734474|P3|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508700|NCT00734474|P2|Participant Flow|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508701|NCT00734474|P1|Participant Flow|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508702|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508703|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508704|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508705|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508706|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508707|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508708|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508709|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508710|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508711|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508712|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508713|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508714|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508715|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508716|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508717|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508718|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508719|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508720|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508721|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
526182|NCT00699608|O1|Outcome|Placebo|Placebo
508722|NCT00734474|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 3.0, 2.0, 1.5, 1.0, 0.75, 0.5, or 0.25 milligrams (mg), subcutaneous (SC), once weekly for up to 104 weeks.~Placebo: tablet, administered orally, once daily for up to 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks"
508723|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508724|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508725|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508726|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508727|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508728|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508729|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508730|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508731|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508732|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508733|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508734|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508735|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508736|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508737|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508738|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508739|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508740|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508741|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508742|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508743|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508744|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508874|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
508745|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508746|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508747|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508748|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508749|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508750|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508751|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508752|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508753|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508754|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508755|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508756|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508757|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508758|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508759|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508760|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508761|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508762|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508763|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508875|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
508764|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508765|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508766|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508767|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508768|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508769|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508770|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508771|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508772|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508773|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508774|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508775|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508776|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508777|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508778|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508779|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508780|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508781|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508782|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508783|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508784|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508785|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508876|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
508786|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508787|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508788|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508789|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508790|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508791|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508792|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508793|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508794|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508795|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508796|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508797|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508798|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508799|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508800|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508801|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508802|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508803|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508804|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508805|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508806|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508807|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508808|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508809|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508810|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508811|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508812|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508813|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508814|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508815|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508816|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508817|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508818|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508819|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508820|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508821|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508822|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508823|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508824|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508825|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508826|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508827|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508828|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508877|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
508829|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508830|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508831|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508832|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508833|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508834|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508835|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508836|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508837|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508838|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508839|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508840|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508841|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508842|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508843|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508844|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508845|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508846|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508847|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508848|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508849|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508878|NCT00734409|E2|Reported Event|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
508850|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508851|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508852|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508853|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508854|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508855|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508856|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508857|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508858|NCT00734474|E9|Reported Event|Placebo/Sitagliptin (Baseline Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily, for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508859|NCT00734474|E8|Reported Event|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508860|NCT00734474|E7|Reported Event|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508861|NCT00734474|E6|Reported Event|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
508862|NCT00734474|E5|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally, for 104 weeks"
508863|NCT00734474|E4|Reported Event|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
508864|NCT00734474|E3|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
508865|NCT00734474|E2|Reported Event|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
508866|NCT00734474|E1|Reported Event|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
508867|NCT00734409|B3|Baseline|Total|Total of all reporting groups
508868|NCT00734409|B2|Baseline|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
508869|NCT00734409|B1|Baseline|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
508870|NCT00734409|P2|Participant Flow|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
508871|NCT00734409|P1|Participant Flow|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
508872|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
508873|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
508879|NCT00734409|E1|Reported Event|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
508880|NCT00734344|B3|Baseline|Total|Total of all reporting groups
508881|NCT00734344|B2|Baseline|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
508882|NCT00734344|B1|Baseline|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
508883|NCT00734344|P2|Participant Flow|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
508884|NCT00734344|P1|Participant Flow|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
508885|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508886|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508887|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508888|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508889|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508890|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508891|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508892|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508893|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508894|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508895|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508896|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508897|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508898|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508899|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508900|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508901|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508902|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508903|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508904|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508905|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508906|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508907|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508908|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508909|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508910|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508911|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508912|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508913|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508914|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508915|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508916|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508917|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508918|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508919|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508920|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508921|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508922|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508923|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508924|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508925|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508926|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508927|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508928|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508929|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508930|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508931|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508932|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508933|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508934|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508935|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508936|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508937|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508938|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508939|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508940|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508941|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508942|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508943|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508944|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508945|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508946|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508947|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
508948|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
508949|NCT00734344|E2|Reported Event|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
508950|NCT00734344|E1|Reported Event|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
508951|NCT00734305|B3|Baseline|Total|Total of all reporting groups
508952|NCT00734305|B2|Baseline|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
508954|NCT00734305|P7|Participant Flow|Expansion Cohort|(Highest tested dose in absence of reaching maximum tolerated dose) 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
508955|NCT00734305|P6|Participant Flow|Dose Escalation: Cohort 6|MM-121: 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
508956|NCT00734305|P5|Participant Flow|Dose Escalation: Cohort 5|MM-121: 20 mg/kg IV QW
508957|NCT00734305|P4|Participant Flow|Dose Escalation: Cohort 4|MM-121: 15 mg/kg IV QW
508958|NCT00734305|P3|Participant Flow|Dose Escalation: Cohort 3|MM-121: 10 mg/kg IV QW
508959|NCT00734305|P2|Participant Flow|Dose Escalation: Cohort 2|MM-121: 6 mg/kg IV QW
508960|NCT00734305|P1|Participant Flow|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
508961|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
508962|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
508963|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
508964|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
508965|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
508966|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
508967|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
508968|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
508969|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
508970|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
508971|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
508972|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
508973|NCT00734305|O6|Outcome|Cohort 6|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses
508974|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
508975|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
508976|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
508977|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
508978|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
508979|NCT00734305|O1|Outcome|Dose Escalation: All Participants|MM-121: Dose escalation Frequency - once weekly
508980|NCT00734305|O7|Outcome|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
508981|NCT00734305|O6|Outcome|Dose Escalation: Cohort 6|MM-121 40 mg/kg IV loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV weekly maintenance doses
508982|NCT00734305|O5|Outcome|Dose Escalation: Cohort 5|MM-121 20 mg/kg IV QW
508983|NCT00734305|O4|Outcome|Dose Escalation: Cohort 4|MM-121 15 mg/kg IV QW
508984|NCT00734305|O3|Outcome|Dose Escalation: Cohort 3|MM-121 10 mg/kg IV QW
508985|NCT00734305|O2|Outcome|Dose Escalation: Cohort 2|MM-121 6 mg/kg IV QW
508986|NCT00734305|O1|Outcome|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
508987|NCT00734305|E1|Reported Event|All Participatants|Dose Escalation cohort participants + Expansion cohort participants
508988|NCT00734214|B3|Baseline|Total|Total of all reporting groups
508989|NCT00734214|B2|Baseline|0.45% NaCl|
508990|NCT00734214|B1|Baseline|0.9% NaCl|
508991|NCT00734214|P2|Participant Flow|0.45% NaCl|
508992|NCT00734214|P1|Participant Flow|0.9% NaCl|
508993|NCT00734214|O2|Outcome|0.45% NaCl|
508994|NCT00734214|O1|Outcome|0.9% NaCl|
508995|NCT00734214|E2|Reported Event|0.45% NaCl|
508996|NCT00734214|E1|Reported Event|0.9% NaCl|
508997|NCT00734162|B5|Baseline|Total|Total of all reporting groups
508998|NCT00734162|B4|Baseline|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
508999|NCT00734162|B3|Baseline|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509000|NCT00734162|B2|Baseline|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509001|NCT00734162|B1|Baseline|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509002|NCT00734162|P4|Participant Flow|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509003|NCT00734162|P3|Participant Flow|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509004|NCT00734162|P2|Participant Flow|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509005|NCT00734162|P1|Participant Flow|TDF 12-14 Years|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509006|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509007|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509008|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509009|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509010|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509011|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509012|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509013|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509014|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509015|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509016|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509017|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509018|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509019|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509020|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509021|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509022|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509023|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509024|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509025|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509026|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509027|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509028|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509029|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509030|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509031|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509032|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509033|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509034|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509035|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509036|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509037|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509038|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509039|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509040|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509041|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509042|NCT00734162|O2|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509043|NCT00734162|O1|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509044|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509045|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509046|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509047|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509048|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509049|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509050|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509051|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509052|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509053|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509054|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509055|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509056|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509057|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509058|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509059|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509060|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509061|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509062|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509063|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509064|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509065|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509066|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509067|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509068|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509069|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509070|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509071|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509072|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509073|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509074|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509075|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509076|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509077|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509078|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509079|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509080|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509081|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509082|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509083|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509084|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509085|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509086|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509087|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509088|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509089|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509090|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509091|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509092|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509093|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509094|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509095|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509096|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509097|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509098|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509099|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509100|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509101|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509102|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509103|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509104|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509105|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509106|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509107|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509108|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509109|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509110|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509111|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509112|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509113|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509114|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509115|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509116|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509117|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509118|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509119|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509120|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509121|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509122|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509123|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509124|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509125|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509126|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509127|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509128|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509129|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509130|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509131|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509132|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509133|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509134|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509135|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509136|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509137|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509138|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509139|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509140|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509141|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509142|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509143|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509144|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509145|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509146|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509147|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509148|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509149|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509150|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509151|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509152|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509153|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509154|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509155|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509156|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509157|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509158|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509159|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509160|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509161|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509162|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509163|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509164|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509165|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509166|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509167|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509168|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509169|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509170|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509171|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509172|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509173|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509174|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509175|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509176|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509177|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509178|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509179|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509180|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509181|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509182|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509183|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509184|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509185|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509186|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509187|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509188|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509189|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509190|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509191|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509192|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509193|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509194|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509195|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509196|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509197|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509198|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509199|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509200|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509201|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509202|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509203|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509204|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509205|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509206|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509207|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509208|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509209|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509210|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509211|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509212|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509213|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509214|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509215|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509216|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509217|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509218|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509219|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509220|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509221|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509222|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509223|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
509224|NCT00734162|E4|Reported Event|Open-Label Placebo-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received placebo during the Randomized Phase of the study and continued to the Open-Label Phase.
509225|NCT00734162|E3|Reported Event|Open-Label TDF-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received double-blind TDF during the Randomized Phase of the study and continued to the Open-Label Phase.
509226|NCT00734162|E2|Reported Event|Double-Blind Placebo|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received placebo during the Randomized Phase of the study.
509227|NCT00734162|E1|Reported Event|Double-Blind TDF|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received double-blind TDF during the Randomized Phase of the study.
509228|NCT00734149|B1|Baseline|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
509229|NCT00734149|P1|Participant Flow|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
509230|NCT00734149|O2|Outcome|Bortezomib+Melphalan+Prednisone: ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients proceeded to autologous stem cell transplant (ASCT).
509231|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone: Non-ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients did not proceed to autologous stem cell transplant (ASCT).
509232|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
509233|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
509234|NCT00734149|E1|Reported Event|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
509235|NCT00734097|B1|Baseline|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509236|NCT00734097|P1|Participant Flow|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509237|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509238|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509239|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509240|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
526183|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
509241|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509242|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509243|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509244|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509245|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509246|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509247|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509248|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509249|NCT00734097|E1|Reported Event|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
509250|NCT00734071|B3|Baseline|Total|Total of all reporting groups
509251|NCT00734071|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509252|NCT00734071|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509253|NCT00734071|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509254|NCT00734071|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509255|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509256|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509257|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509258|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509259|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509260|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509261|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509262|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509263|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509264|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509265|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509266|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509267|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509268|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509269|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509270|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509271|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509272|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509273|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509274|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509275|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509276|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509277|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509278|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509279|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509280|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509281|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509282|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509283|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509284|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509285|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509286|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509287|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509288|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509289|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509290|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509291|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509292|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509293|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509294|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
526184|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
509295|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509296|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509297|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509298|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509299|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509300|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509301|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509302|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509303|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509304|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509305|NCT00734071|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
509306|NCT00734071|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
509307|NCT00734032|B5|Baseline|Total|Total of all reporting groups
509308|NCT00734032|B4|Baseline|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509309|NCT00734032|B3|Baseline|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509310|NCT00734032|B2|Baseline|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509311|NCT00734032|B1|Baseline|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509312|NCT00734032|P4|Participant Flow|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509313|NCT00734032|P3|Participant Flow|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509314|NCT00734032|P2|Participant Flow|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509315|NCT00734032|P1|Participant Flow|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509316|NCT00734032|O4|Outcome|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509317|NCT00734032|O3|Outcome|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509318|NCT00734032|O2|Outcome|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509319|NCT00734032|O1|Outcome|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509320|NCT00734032|O4|Outcome|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509321|NCT00734032|O3|Outcome|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509322|NCT00734032|O2|Outcome|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509323|NCT00734032|O1|Outcome|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509324|NCT00734032|O4|Outcome|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509325|NCT00734032|O3|Outcome|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509326|NCT00734032|O2|Outcome|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509327|NCT00734032|O1|Outcome|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509328|NCT00734032|E4|Reported Event|SB-480848 160 mg|Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509329|NCT00734032|E3|Reported Event|SB-480848 80 mg|Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509330|NCT00734032|E2|Reported Event|SB-480848 40 mg|Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509331|NCT00734032|E1|Reported Event|Placebo|Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
509332|NCT00733993|B3|Baseline|Total|Total of all reporting groups
509333|NCT00733993|B2|Baseline|Control Participants|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
509334|NCT00733993|B1|Baseline|Cocaine Users|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
509383|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509335|NCT00733993|P2|Participant Flow|Control Participants|"Control participants were allocated to different sequence orders for the 5 interventions~Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509336|NCT00733993|P1|Participant Flow|Cocaine Users|"Cocaine users were allocated to different sequence orders for the 5 interventions~Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509337|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
509338|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
509339|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
509340|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509341|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
509342|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
509343|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
509344|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509345|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
509346|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
509347|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
509348|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509349|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
509350|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
509351|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
509352|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509353|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
509354|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
509355|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
509356|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509357|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
509358|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
509359|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
509360|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509361|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
509362|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
509363|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
509364|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509365|NCT00733993|E3|Reported Event|3 Amphetamine|Amphetamine: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
509366|NCT00733993|E2|Reported Event|2 Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509367|NCT00733993|E1|Reported Event|1 Caffeine|"Caffeine~Caffeine: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
509368|NCT00733980|B3|Baseline|Total|Total of all reporting groups
509369|NCT00733980|B2|Baseline|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509370|NCT00733980|B1|Baseline|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509371|NCT00733980|P2|Participant Flow|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening.
509372|NCT00733980|P1|Participant Flow|GSK561679|The participants in this arm received GSK561679, 350 milligram (mg) orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks.
509373|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509374|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509375|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509376|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509377|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509378|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509379|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509380|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509381|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509382|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509384|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509385|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509386|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509387|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509388|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509389|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509390|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509391|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509392|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509393|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509394|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509395|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509396|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509397|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509398|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509399|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509400|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509401|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509402|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509403|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509404|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 milligram (mg) orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509405|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509406|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509407|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509408|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509409|NCT00733980|O2|Outcome|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509410|NCT00733980|O1|Outcome|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509411|NCT00733980|E2|Reported Event|Placebo|The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
509412|NCT00733980|E1|Reported Event|GSK561679|The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
509413|NCT00733954|B3|Baseline|Total|Total of all reporting groups
509414|NCT00733954|B2|Baseline|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509415|NCT00733954|B1|Baseline|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509416|NCT00733954|P2|Participant Flow|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509417|NCT00733954|P1|Participant Flow|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509418|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509419|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509420|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509421|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509422|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509423|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509424|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509425|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509426|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509427|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509428|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509429|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509430|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509431|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509432|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509433|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509434|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509435|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509436|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509437|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509438|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509439|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509440|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509441|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509442|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509443|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509444|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509445|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509446|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509447|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509448|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509449|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509450|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509451|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509452|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509453|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509454|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509455|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509456|NCT00733954|E2|Reported Event|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
509457|NCT00733954|E1|Reported Event|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
509458|NCT00733824|B6|Baseline|Total|Total of all reporting groups
509459|NCT00733824|B5|Baseline|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509460|NCT00733824|B4|Baseline|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509461|NCT00733824|B3|Baseline|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509462|NCT00733824|B2|Baseline|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509463|NCT00733824|B1|Baseline|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509464|NCT00733824|P5|Participant Flow|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509465|NCT00733824|P4|Participant Flow|Phase I - Cohort 4|240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
509466|NCT00733824|P3|Participant Flow|Phase I - Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509467|NCT00733824|P2|Participant Flow|Phase I - Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509468|NCT00733824|P1|Participant Flow|Phase I - Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509469|NCT00733824|O5|Outcome|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)~AMD3100~G-CSF~Apheresis"
509470|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509471|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509472|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509473|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509474|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
509475|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
509476|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509477|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509478|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509479|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509480|NCT00733824|O1|Outcome|Phase 1 (Dose Levels 1-4)|
509481|NCT00733824|E5|Reported Event|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509482|NCT00733824|E4|Reported Event|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509483|NCT00733824|E3|Reported Event|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509484|NCT00733824|E2|Reported Event|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509485|NCT00733824|E1|Reported Event|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
509486|NCT00733746|B1|Baseline|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509487|NCT00733746|P1|Participant Flow|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509488|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509489|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509490|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509491|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509538|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509539|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509540|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509492|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509493|NCT00733746|E1|Reported Event|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
509494|NCT00733512|B1|Baseline|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
509495|NCT00733512|P1|Participant Flow|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
509496|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
509497|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
509498|NCT00733512|E1|Reported Event|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
509499|NCT00733499|B3|Baseline|Total|Total of all reporting groups
509500|NCT00733499|B2|Baseline|LCS Complete Porocoat|102 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
509501|NCT00733499|B1|Baseline|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
509502|NCT00733499|P2|Participant Flow|LCS Complete Porocoat|103 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
509503|NCT00733499|P1|Participant Flow|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
509504|NCT00733499|O2|Outcome|LCS Complete Porocoat|102 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
509505|NCT00733499|O1|Outcome|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
509506|NCT00733499|E2|Reported Event|LCS Complete Porocoat|103 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
509507|NCT00733499|E1|Reported Event|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
509508|NCT00733421|B3|Baseline|Total|Total of all reporting groups
509509|NCT00733421|B2|Baseline|Control Tramadol|Tramadol 100 mg slow release twice daily
509510|NCT00733421|B1|Baseline|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509511|NCT00733421|P2|Participant Flow|Control Tramadol|Tramadol 100 mg slow release twice daily
509512|NCT00733421|P1|Participant Flow|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509513|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509514|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509515|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509516|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509517|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509518|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509519|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509520|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509521|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509522|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509523|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509524|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509525|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509526|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509527|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509528|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509529|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
509530|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509531|NCT00733421|E2|Reported Event|Control Tramadol|Tramadol 100 mg slow release twice daily
509532|NCT00733421|E1|Reported Event|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
509533|NCT00733369|B3|Baseline|Total|Total of all reporting groups
509534|NCT00733369|B2|Baseline|PFC Sigma RP|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing"
509535|NCT00733369|B1|Baseline|PFC Sigma RP-F|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing"
509536|NCT00733369|P2|Participant Flow|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509537|NCT00733369|P1|Participant Flow|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509904|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
509541|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509542|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509543|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509544|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509545|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509546|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509547|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509548|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509549|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509550|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509551|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509552|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509553|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509554|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509555|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509556|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509557|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509558|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509559|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509560|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509561|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509562|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509563|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509564|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509565|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509566|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509567|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509568|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509569|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509570|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509571|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509572|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509573|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509574|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509575|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509576|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509577|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509578|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509579|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509580|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509581|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509582|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509583|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509584|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509585|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509586|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509587|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509588|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509589|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509590|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509591|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509592|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509593|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509594|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509595|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509596|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509597|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509598|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509599|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509600|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509601|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509602|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509603|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509604|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509605|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509606|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509607|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509608|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509609|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509610|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509611|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509612|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509613|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509614|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509615|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509616|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509617|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509618|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509619|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509620|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509621|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509622|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509623|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509624|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509625|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509626|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509627|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509628|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509629|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509630|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509631|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509632|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509633|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509634|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509635|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509636|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509637|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509638|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509639|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509640|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509641|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509642|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509643|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509644|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509645|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509646|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509647|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509648|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509649|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509650|NCT00733369|E2|Reported Event|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
509651|NCT00733369|E1|Reported Event|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
509652|NCT00733356|B1|Baseline|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
509653|NCT00733356|P1|Participant Flow|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
509654|NCT00733356|O1|Outcome|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
509655|NCT00733356|E1|Reported Event|ADHD With Vyvanse Treatment|All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
509656|NCT00733330|B3|Baseline|Total|Total of all reporting groups
509657|NCT00733330|B2|Baseline|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509658|NCT00733330|B1|Baseline|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509659|NCT00733330|P2|Participant Flow|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509660|NCT00733330|P1|Participant Flow|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509661|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509662|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509663|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509664|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509665|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509666|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509667|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509668|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509669|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509670|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509671|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509672|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509673|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509674|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509675|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509676|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509677|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509678|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509679|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509680|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509681|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509682|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509683|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509684|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509685|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509686|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509687|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509688|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509689|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509690|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509691|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509692|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509693|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509694|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509695|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509696|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509697|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509698|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509699|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509700|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509701|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509702|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509703|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509704|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509705|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509706|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509707|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509708|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509709|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509710|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509711|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509712|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509713|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509714|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509715|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509716|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509717|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509718|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509719|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509720|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509721|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509722|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509723|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509724|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509725|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509726|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509727|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509728|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509729|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509730|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509731|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509732|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509733|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509734|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509735|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509736|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509737|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509738|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
509739|NCT00733330|E2|Reported Event|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
509740|NCT00733330|E1|Reported Event|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
509741|NCT00733304|B4|Baseline|Total|Total of all reporting groups
509742|NCT00733304|B3|Baseline|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
509743|NCT00733304|B2|Baseline|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
509744|NCT00733304|B1|Baseline|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
509745|NCT00733304|P3|Participant Flow|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
509746|NCT00733304|P2|Participant Flow|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
509747|NCT00733304|P1|Participant Flow|5 mg/mL TID|Eligible participants received 5 milligram/milliliter (mg/mL) Pazopanib eye drops three times daily for a treatment period of five months.
509748|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509749|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509750|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509751|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509752|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509753|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509754|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509755|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509756|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509757|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509905|NCT00733096|E3|Reported Event|Saline|Two epidural saline injections
509758|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509759|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509760|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509761|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509762|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509763|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509764|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509765|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509766|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509767|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509768|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509769|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509770|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509771|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509772|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509773|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509774|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509775|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509776|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509777|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509778|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509779|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509780|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509781|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509782|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509783|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509784|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509785|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509786|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509787|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509788|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
526185|NCT00699608|O1|Outcome|Placebo|Placebo
509789|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509790|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509791|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509792|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509793|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509794|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509795|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509796|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509797|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509798|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509799|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509800|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509801|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509802|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509803|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509804|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509805|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509806|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509807|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509808|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509809|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509810|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509811|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509812|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509813|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509814|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509815|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509816|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509817|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509818|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509819|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
526186|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
509820|NCT00733304|O3|Outcome|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509821|NCT00733304|O2|Outcome|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509822|NCT00733304|O1|Outcome|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
509823|NCT00733304|E3|Reported Event|5 mg/mL QD|Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
509824|NCT00733304|E2|Reported Event|2 mg/mL TID|Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
509825|NCT00733304|E1|Reported Event|5 mg/mL TID|Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
509826|NCT00733291|B3|Baseline|Total|Total of all reporting groups
509827|NCT00733291|B2|Baseline|Etafilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
509828|NCT00733291|B1|Baseline|Nelfilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
509829|NCT00733291|P4|Participant Flow|Etafilcon A no Soak / Etafilcon Soak|Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
509830|NCT00733291|P3|Participant Flow|Etafilcon A Soak / Etafilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
509831|NCT00733291|P2|Participant Flow|Nelfilcon A no Soak / Nelfilcon A Soak|Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
509832|NCT00733291|P1|Participant Flow|Nelfilcon A Soak / Nelfilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
509833|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
509834|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509835|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
509836|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509837|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
509838|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509839|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
509840|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509841|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
509842|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509843|NCT00733291|O2|Outcome|Nelfilcon A / No Soak|Nelfilcon A contact lenses inserted directly out of the blister package
509844|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509845|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
509846|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509847|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
509848|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509849|NCT00733291|E4|Reported Event|Etafilcon / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
509850|NCT00733291|E3|Reported Event|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509851|NCT00733291|E2|Reported Event|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
509852|NCT00733291|E1|Reported Event|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
509853|NCT00733278|B1|Baseline|IUD Placement|
509854|NCT00733278|P1|Participant Flow|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
509855|NCT00733278|O1|Outcome|IUD Strings|Visibility of IUD strings within the vagina at all times.
509856|NCT00733278|O1|Outcome|IUD Placement|IUD placement following removal of placenta at time of elective C-section
509857|NCT00733278|E1|Reported Event|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
509858|NCT00733226|B3|Baseline|Total|Total of all reporting groups
509859|NCT00733226|B2|Baseline|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509860|NCT00733226|B1|Baseline|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509906|NCT00733096|E2|Reported Event|Etanercept|Two epidural etanercept injections
509861|NCT00733226|P2|Participant Flow|Placebo Group|The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509862|NCT00733226|P1|Participant Flow|Broncho-Vaxom Group|The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509863|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509864|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509865|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509866|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509867|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509868|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509869|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509870|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509871|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509872|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509873|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509874|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509875|NCT00733226|E2|Reported Event|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
509876|NCT00733226|E1|Reported Event|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
509877|NCT00733135|B1|Baseline|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
509878|NCT00733135|P1|Participant Flow|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
509879|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
509880|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
509881|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
509882|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk™ plaque excision systems with the SpiderFX™ embolic protection device placed distally.
509883|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
509884|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
509885|NCT00733135|E1|Reported Event|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
509886|NCT00733096|B4|Baseline|Total|Total of all reporting groups
509887|NCT00733096|B3|Baseline|Saline|Two epidural saline injections
509888|NCT00733096|B2|Baseline|Etanercept|Two epidural etanercept injections
509889|NCT00733096|B1|Baseline|Steroid|Two epidural steroid injections
509890|NCT00733096|P3|Participant Flow|Saline|Two epidural saline injections
509891|NCT00733096|P2|Participant Flow|Etanercept|Two epidural etanercept injections
509892|NCT00733096|P1|Participant Flow|Steroid|Two epidural steroid injections
509893|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
509894|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
509895|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
509896|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
509897|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
509898|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
509899|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
509900|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
509901|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
509902|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
509903|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
509907|NCT00733096|E1|Reported Event|Steroid|Two epidural steroid injections
509908|NCT00733005|B3|Baseline|Total|Total of all reporting groups
509909|NCT00733005|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
509910|NCT00733005|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
509911|NCT00733005|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
509912|NCT00733005|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
509913|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
509914|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
509915|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
509916|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
509917|NCT00733005|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
509918|NCT00733005|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
509919|NCT00732992|B3|Baseline|Total|Total of all reporting groups
509920|NCT00732992|B2|Baseline|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
509921|NCT00732992|B1|Baseline|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509922|NCT00732992|P2|Participant Flow|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
509923|NCT00732992|P1|Participant Flow|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509924|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
509925|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509926|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
509927|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509928|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509929|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509930|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509931|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509932|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509933|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
509934|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509935|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
509936|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509937|NCT00732992|E2|Reported Event|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
509938|NCT00732992|E1|Reported Event|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
509939|NCT00732940|B3|Baseline|Total|Total of all reporting groups
509940|NCT00732940|B2|Baseline|Belimumab SC 3X/WK|
509941|NCT00732940|B1|Baseline|Belimumab SC Q2WKS|
509942|NCT00732940|P2|Participant Flow|Belimumab SC 3X/WK|200 mg of belimumab (2 subcutaneous injections of 100 mg each) on days 0, 2, and 4 then 100 mg three times a week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
509943|NCT00732940|P1|Participant Flow|Belimumab SC Q2WKS|100 mg of belimumab (1 subcutaneous injection) on days 0, 7, and 14, then every other week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
509944|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509945|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509946|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509947|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509948|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509949|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509950|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509951|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509952|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509953|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509954|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509955|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509956|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509957|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509958|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509959|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509960|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509961|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509962|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509963|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509964|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509965|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509966|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509967|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509968|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509969|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509970|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509971|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509972|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509973|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509974|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509975|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509976|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509977|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509978|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509979|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509980|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509981|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509982|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509983|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509984|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509985|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509986|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509987|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509988|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509989|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509990|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509991|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509992|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509993|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509994|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509995|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509996|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509997|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
509998|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
509999|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
510000|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
510001|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
510002|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
510003|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
510004|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
510005|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
510006|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
510007|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
510008|NCT00732940|E2|Reported Event|Belimumab SC 3X/WK|The 3x/wk group will receive 200 mg of belimumab (2 injections of 100 mg each) plus standard therapy on Days 0, 2, and 4 and then 100 mg (1 injection) 3 times per week thereafter.
510009|NCT00732940|E1|Reported Event|Belimumab SC Q2WKS|The Q2wk group will receive 100 mg of belimumab (1 injection) plus standard therapy on Days 0, 7, 14, and then every 2 weeks thereafter.
510010|NCT00732901|B3|Baseline|Total|Total of all reporting groups
510011|NCT00732901|B2|Baseline|B (Placebo)|Placebo once daily for days 1-28
510012|NCT00732901|B1|Baseline|A (Escitalopram)|Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28
510013|NCT00732901|P2|Participant Flow|B (Placebo)|"Placebo~Placebo: once daily for days 1-28"
510014|NCT00732901|P1|Participant Flow|A (Escitalopram)|"Escitalopram~Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28"
510015|NCT00732901|O2|Outcome|B (Placebo)|"Placebo~Placebo: daily for days 1-28"
510016|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram~Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
510017|NCT00732901|O2|Outcome|B (Placebo)|"Placebo~Placebo: daily for days 1-28"
510018|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram~Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
510019|NCT00732901|O2|Outcome|B (Placebo)|"Placebo~Placebo: daily for days 1-28"
510020|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram~Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
510021|NCT00732901|E2|Reported Event|B (Placebo)|"Placebo~Placebo: once daily for days 1-28"
510022|NCT00732901|E1|Reported Event|A (Escitalopram)|"Escitalopram~Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28"
510023|NCT00732875|B1|Baseline|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
510024|NCT00732875|P1|Participant Flow|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
510025|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
510026|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
510027|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
510028|NCT00732875|E1|Reported Event|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
510029|NCT00732758|B3|Baseline|Total|Total of all reporting groups
510030|NCT00732758|B2|Baseline|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
510031|NCT00732758|B1|Baseline|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
510032|NCT00732758|P2|Participant Flow|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
510033|NCT00732758|P1|Participant Flow|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
510034|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
510035|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
510036|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
510037|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
510038|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
510039|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
510040|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
510041|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
510042|NCT00732758|E2|Reported Event|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
510043|NCT00732758|E1|Reported Event|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
510044|NCT00732680|B1|Baseline|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
510045|NCT00732680|P1|Participant Flow|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
510046|NCT00732680|O1|Outcome|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
510047|NCT00732680|E1|Reported Event|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
510048|NCT00732654|B4|Baseline|Total|Total of all reporting groups
510049|NCT00732654|B3|Baseline|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
510050|NCT00732654|B2|Baseline|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
510051|NCT00732654|B1|Baseline|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
510052|NCT00732654|P3|Participant Flow|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
510053|NCT00732654|P2|Participant Flow|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
510054|NCT00732654|P1|Participant Flow|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
510094|NCT00732615|P2|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
510095|NCT00732615|P1|Participant Flow|Placebo|Matching Placebo: Placebo for subcutaneous injection
510096|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
510097|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
510098|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
510055|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
510056|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
510057|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
510058|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
510059|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
510060|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
510061|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
510062|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
510063|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
510099|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
510100|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
510101|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
510102|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
526187|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
510064|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
510065|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
510066|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
510067|NCT00732654|E3|Reported Event|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
510068|NCT00732654|E2|Reported Event|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
510069|NCT00732654|E1|Reported Event|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
510070|NCT00732641|B3|Baseline|Total|Total of all reporting groups
510071|NCT00732641|B2|Baseline|No Treatment|Participants were observed and received no treatment
510072|NCT00732641|B1|Baseline|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510073|NCT00732641|P2|Participant Flow|No Treatment|Participants were observed and received no treatment
510074|NCT00732641|P1|Participant Flow|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510075|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
510076|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510077|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
510078|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510079|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
510080|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510081|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
510082|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510083|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
510084|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510085|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
510086|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510087|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
510088|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510089|NCT00732641|E2|Reported Event|No Treatment|Participants were observed and received no treatment
510090|NCT00732641|E1|Reported Event|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
510091|NCT00732615|B3|Baseline|Total|Total of all reporting groups
510092|NCT00732615|B2|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
510093|NCT00732615|B1|Baseline|Placebo|Matching Placebo: Placebo for subcutaneous injection
510103|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
510104|NCT00732615|E2|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
510105|NCT00732615|E1|Reported Event|Placebo|Matching Placebo: Placebo for subcutaneous injection
510106|NCT00732472|B5|Baseline|Total|Total of all reporting groups
510107|NCT00732472|B4|Baseline|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510108|NCT00732472|B3|Baseline|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510109|NCT00732472|B2|Baseline|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510110|NCT00732472|B1|Baseline|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510111|NCT00732472|P4|Participant Flow|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510112|NCT00732472|P3|Participant Flow|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510113|NCT00732472|P2|Participant Flow|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510114|NCT00732472|P1|Participant Flow|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510115|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510116|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510117|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510118|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510119|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510120|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510121|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510122|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510123|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510124|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510125|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510126|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510127|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510128|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510129|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510130|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510131|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510132|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510133|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510134|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510135|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510136|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510137|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510138|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510139|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510140|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510141|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510142|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510143|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510144|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510145|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510146|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510147|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510148|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510149|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510150|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510151|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510152|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510153|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510154|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510155|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510156|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510157|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510158|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510159|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510160|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC19 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510161|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510162|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510163|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510164|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510165|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510166|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510167|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510168|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510556|NCT00731692|E2|Reported Event|Core: FTY720 0.5 mg|Patients who received FTY720 0.5 mg during core
510169|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510170|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510171|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510172|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510173|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510174|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510175|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510176|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510177|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510178|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510179|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510180|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510181|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510182|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510183|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510184|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510185|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510186|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510187|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510188|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510189|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510190|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510191|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510192|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510193|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510194|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510195|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510196|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510197|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510198|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510199|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510200|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510557|NCT00731692|E1|Reported Event|Core: FTY720 1.25 mg|Patients who received FTY720 1.25 mg during core
510201|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510202|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510203|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510204|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510205|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510206|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510207|NCT00732472|E4|Reported Event|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
510208|NCT00732472|E3|Reported Event|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
510209|NCT00732472|E2|Reported Event|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
510210|NCT00732472|E1|Reported Event|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
510211|NCT00732381|B3|Baseline|Total|Total of all reporting groups
510212|NCT00732381|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
510213|NCT00732381|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
510214|NCT00732381|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
510215|NCT00732381|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
510216|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
510217|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
510218|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
510219|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
510220|NCT00732381|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
510221|NCT00732381|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
510222|NCT00732303|B1|Baseline|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
510223|NCT00732303|P1|Participant Flow|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
510224|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
510225|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
510226|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
510227|NCT00732303|E1|Reported Event|Pemetrexed\Radiation|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
510228|NCT00732251|B1|Baseline|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
510229|NCT00732251|P1|Participant Flow|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
510230|NCT00732251|O1|Outcome|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
510231|NCT00732251|E1|Reported Event|Allopurinol|Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period
510232|NCT00732238|B3|Baseline|Total|Total of all reporting groups
510233|NCT00732238|B2|Baseline|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
510234|NCT00732238|B1|Baseline|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
510235|NCT00732238|P2|Participant Flow|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
510236|NCT00732238|P1|Participant Flow|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
510237|NCT00732238|O2|Outcome|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
510238|NCT00732238|O1|Outcome|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
510239|NCT00732238|O2|Outcome|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
510240|NCT00732238|O1|Outcome|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
510241|NCT00732238|E2|Reported Event|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
510242|NCT00732238|E1|Reported Event|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
510243|NCT00732225|B6|Baseline|Total|Total of all reporting groups
510244|NCT00732225|B5|Baseline|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510245|NCT00732225|B4|Baseline|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510246|NCT00732225|B3|Baseline|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510247|NCT00732225|B2|Baseline|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510558|NCT00731679|B3|Baseline|Total|Total of all reporting groups
510248|NCT00732225|B1|Baseline|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510249|NCT00732225|P5|Participant Flow|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510250|NCT00732225|P4|Participant Flow|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510251|NCT00732225|P3|Participant Flow|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510252|NCT00732225|P2|Participant Flow|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510253|NCT00732225|P1|Participant Flow|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510254|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510255|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510256|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510257|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510258|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510259|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510260|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510261|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510262|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510263|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510264|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510265|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510266|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510267|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510268|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510269|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510270|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510271|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510272|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510273|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510274|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510275|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510276|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510277|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510278|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510279|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510280|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510281|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510282|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510283|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510284|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510285|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510286|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510287|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510288|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510289|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510290|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510291|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510292|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510293|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510294|NCT00732225|E5|Reported Event|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
510295|NCT00732225|E4|Reported Event|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
510296|NCT00732225|E3|Reported Event|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
510660|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510297|NCT00732225|E2|Reported Event|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
510298|NCT00732225|E1|Reported Event|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
510299|NCT00732212|B5|Baseline|Total|Total of all reporting groups
510300|NCT00732212|B4|Baseline|Doppler Variceal Group|Doppler variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
510301|NCT00732212|B3|Baseline|Standard Variceal Group|Standard variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
510302|NCT00732212|B2|Baseline|Doppler Non-variceal Group|Doppler non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
510303|NCT00732212|B1|Baseline|Standard Non-variceal Group|Standard non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
510304|NCT00732212|P2|Participant Flow|Standard Endoscopic Hemostasis|"Standard, visually guided endoscopic hemostasis based on visual cues of stigmata of hemorrhage and endoscopic control of bleeding or treatment of the stigmata according to current guidelines~Standard endoscopic hemostasis: Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage & visual cues for risk stratification and completion of endoscopic treatment."
510305|NCT00732212|P1|Participant Flow|Doppler Endoscopic Probe Assisted Hemostasis|"In addition to stigmata of hemorrhage and visual cues, Doppler endoscopic probe will be used for detection of blood flow before and after standard endoscopic hemostasis. If residual blood flow in the lesion is found after standard treatment, further endoscopic treatment will be applied as deemed safe by the investigator-endoscopist.~Doppler endoscopic ultrasound probe is used for blood flow detection"
510306|NCT00732212|O4|Outcome|Doppler Variceal Group|Length of hospitalization days in Doppler assisted variceal patients.
510307|NCT00732212|O3|Outcome|Standard Variceal Group|Length of hospitalization days in standard visually guided hemostasis variceal patients.
510308|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Length of hospitalization days in Doppler assisted non-variceal patients.
510309|NCT00732212|O1|Outcome|Standard Non-variceal Group|Length of hospitalization days in standard visually guided hemostasis non-variceal patients.
510310|NCT00732212|O4|Outcome|Doppler Variceal Group|RBC units of transfusion post-randomization in Doppler assisted variceal patients.
510311|NCT00732212|O3|Outcome|Standard Variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis variceal patients.
510312|NCT00732212|O2|Outcome|Doppler Non-variceal Group|RBC units of transfusion post-randomization in Doppler assisted non-variceal patients.
510313|NCT00732212|O1|Outcome|Standard Non-variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis non-variceal patients.
510314|NCT00732212|O4|Outcome|Doppler Variceal Group|Number of deaths in Doppler assisted variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
510315|NCT00732212|O3|Outcome|Standard Variceal Group|Number of deaths in standard visually guided hemostasis variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
510316|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Number of deaths in Doppler assisted non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
510317|NCT00732212|O1|Outcome|Standard Non-variceal Group|Number of deaths in standard visually guided hemostasis non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
510318|NCT00732212|O4|Outcome|Doppler Variceal Patients|Rate of Doppler assisted variceal patients who had complications within 30 days.
510319|NCT00732212|O3|Outcome|Standard Variceal Group|Rate of standard visually guided hemostasis variceal patients who had complications within 30 days.
510320|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Rate of Doppler assisted non-variceal patients who had complications within 30 days.
510321|NCT00732212|O1|Outcome|Standard Non-variceal Group|Rate of standard visually guided hemostasis non-variceal patients who had complications within 30 days.
510322|NCT00732212|O4|Outcome|Doppler Variceal Group|30 day rate of surgery in Doppler assisted variceal patients.
510323|NCT00732212|O3|Outcome|Standard Variceal Group|30 day rate of surgery in standard visually guided hemostasis variceal patients.
510324|NCT00732212|O2|Outcome|Doppler Non-variceal Group|30 day rate of surgery in Doppler assisted non-variceal patients.
510325|NCT00732212|O1|Outcome|Standard Non-variceal Group|30 day rate of surgery in standard visually guided hemostasis non-variceal patients.
510326|NCT00732212|O4|Outcome|Doppler Variceal Group|30 day rebleeding rate in Doppler assisted variceal patients.
510327|NCT00732212|O3|Outcome|Standard Variceal Group|30 day rebleeding rate in standard variceal visually guided hemostasis patients.
510328|NCT00732212|O2|Outcome|Doppler Non-variceal Group|30 day rebleeding rate in Doppler assisted non-variceal patients.
510329|NCT00732212|O1|Outcome|Standard Non-variceal Group|30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
510330|NCT00732212|E4|Reported Event|Doppler Variceal Group|Serious adverse events in Doppler variceal visually guided hemostasis patients.
510331|NCT00732212|E3|Reported Event|Standard Variceal Group|Serious adverse events in standard variceal visually guided hemostasis patients.
510332|NCT00732212|E2|Reported Event|Doppler Non-variceal Group|Serious adverse events in Doppler non-variceal patients.
510333|NCT00732212|E1|Reported Event|Standard Non-variceal Group|Serious adverse events in standard non-variceal visually guided hemostasis patients.
510334|NCT00732199|B3|Baseline|Total|Total of all reporting groups
510335|NCT00732199|B2|Baseline|Healthy Older Adults|"Healthy Older adults, age >55-60yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
510336|NCT00732199|B1|Baseline|Health Young Adults|"Health Young adults, age 18-50 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
510337|NCT00732199|P2|Participant Flow|Arm 2|"Older adults, age >/=60 yrs~hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation"
510338|NCT00732199|P1|Participant Flow|Arm 1|"Young adults, age 18-59yrs~hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation"
510339|NCT00732199|O2|Outcome|Healthy Older Adults|Older adults
510340|NCT00732199|O1|Outcome|Healthy Young Adults|Young adults
510341|NCT00732199|O2|Outcome|Healthy Older Adults|Older adults
510342|NCT00732199|O1|Outcome|Healthy Young Adults|Young adults
510343|NCT00732199|O1|Outcome|Healthy Older Adults|Older adults
510344|NCT00732199|O2|Outcome|Healthy Old Adults|"Older adults, age >60 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
510345|NCT00732199|O1|Outcome|Healthy Young Adults|"Young adults, age 18-50 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
510346|NCT00732199|E2|Reported Event|Healthy Older Adults|"Older adults, age >55-60 years~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
510347|NCT00732199|E1|Reported Event|Healthy Young Adults|"Young adults, age 18-50 yrs~hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation"
510348|NCT00732160|B5|Baseline|Total|Total of all reporting groups
510349|NCT00732160|B4|Baseline|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
510350|NCT00732160|B3|Baseline|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
510351|NCT00732160|B2|Baseline|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
510352|NCT00732160|B1|Baseline|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
510353|NCT00732160|P4|Participant Flow|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
510354|NCT00732160|P3|Participant Flow|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
510355|NCT00732160|P2|Participant Flow|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
510356|NCT00732160|P1|Participant Flow|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
510357|NCT00732160|O4|Outcome|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
510358|NCT00732160|O3|Outcome|Aldosterone, HS|Aldosterone Infusion, High Salt diet
510359|NCT00732160|O2|Outcome|Vehicle, LS|Vehicle Infusion, Low Salt diet
510360|NCT00732160|O1|Outcome|Vehicle, HS|Vehicle Infusion, High Salt diet
510361|NCT00732160|O4|Outcome|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
510362|NCT00732160|O3|Outcome|Aldosterone, HS|Aldosterone Infusion, High Salt diet
510363|NCT00732160|O2|Outcome|Vehicle, LS|Vehicle Infusion, Low Salt diet
510364|NCT00732160|O1|Outcome|Vehicle, HS|Vehicle Infusion, High Salt diet
510365|NCT00732160|E4|Reported Event|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
510366|NCT00732160|E3|Reported Event|Aldosterone, HS|Aldosterone Infusion, High Salt diet
510367|NCT00732160|E2|Reported Event|Vehicle, LS|Vehicle Infusion, Low Salt diet
510368|NCT00732160|E1|Reported Event|Vehicle, HS|Vehicle Infusion, High Salt diet
510369|NCT00732069|B1|Baseline|All Study Participants|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
510370|NCT00732069|P6|Participant Flow|Valsartan, Ramipril, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
510371|NCT00732069|P5|Participant Flow|Ramipril, Valsartan, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
510372|NCT00732069|P4|Participant Flow|Valsartan, Then Placebo, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
510373|NCT00732069|P3|Participant Flow|Ramipril, Then Placebo, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
510374|NCT00732069|P2|Participant Flow|Placebo, Valsartan, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
510375|NCT00732069|P1|Participant Flow|Placebo, Then Ramipril, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
510376|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
510377|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
510378|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
510379|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
510380|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
510381|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
510382|NCT00732069|E3|Reported Event|Placebo|All subjects receiving placebo
510383|NCT00732069|E2|Reported Event|Valsartan|All subjects receiving valsartan
510384|NCT00732069|E1|Reported Event|Ramipril|All subjects receiving ramipril
510385|NCT00732030|B1|Baseline|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
510386|NCT00732030|P1|Participant Flow|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
510387|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
510388|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
510389|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
510390|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
510391|NCT00732030|E1|Reported Event|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
510392|NCT00731939|B1|Baseline|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510393|NCT00731939|P1|Participant Flow|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510394|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510395|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510396|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510397|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510398|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510399|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510400|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510401|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510402|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510403|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510404|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510405|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510406|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510407|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510408|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510409|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510410|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510411|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510412|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510413|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510414|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510415|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510416|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510417|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510418|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510419|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510420|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510421|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510422|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510423|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510424|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510425|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510426|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510427|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510428|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510429|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510430|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510431|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510432|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510433|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510434|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510435|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510436|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510437|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510477|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510438|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510439|NCT00731939|E1|Reported Event|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
510440|NCT00731874|B3|Baseline|Total|Total of all reporting groups
510441|NCT00731874|B2|Baseline|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510442|NCT00731874|B1|Baseline|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510443|NCT00731874|P2|Participant Flow|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510444|NCT00731874|P1|Participant Flow|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510445|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510446|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510447|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510448|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510449|NCT00731874|E2|Reported Event|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510450|NCT00731874|E1|Reported Event|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
510451|NCT00731822|B3|Baseline|Total|Total of all reporting groups
510452|NCT00731822|B2|Baseline|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
510453|NCT00731822|B1|Baseline|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
510454|NCT00731822|P2|Participant Flow|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
510455|NCT00731822|P1|Participant Flow|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
510456|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
510457|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
510458|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
510459|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
510460|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
510461|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
510462|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
510463|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
510464|NCT00731822|E2|Reported Event|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
510465|NCT00731822|E1|Reported Event|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
510466|NCT00731783|B3|Baseline|Total|Total of all reporting groups
510467|NCT00731783|B2|Baseline|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510468|NCT00731783|B1|Baseline|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510469|NCT00731783|P2|Participant Flow|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
510470|NCT00731783|P1|Participant Flow|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
510471|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510472|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510473|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510474|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510475|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510476|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
526188|NCT00699608|O1|Outcome|Placebo|Placebo
510478|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510479|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510480|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510481|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510482|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510483|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510484|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510485|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510486|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510487|NCT00731783|E2|Reported Event|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
510488|NCT00731783|E1|Reported Event|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
510489|NCT00731731|B4|Baseline|Total|Total of all reporting groups
510490|NCT00731731|B3|Baseline|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510491|NCT00731731|B2|Baseline|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510492|NCT00731731|B1|Baseline|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510493|NCT00731731|P3|Participant Flow|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510494|NCT00731731|P2|Participant Flow|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510495|NCT00731731|P1|Participant Flow|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510496|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
510512|NCT00731692|B1|Baseline|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
515258|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
510497|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
510498|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
510499|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
510500|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510501|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510502|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510503|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510504|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510505|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
510506|NCT00731731|E3|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
510507|NCT00731731|E2|Reported Event|Phase I, Dose Level 1|laboratory biomarker analysis: Correlative studies
510508|NCT00731731|E1|Reported Event|Phase I, Dose Level 0|laboratory biomarker analysis: Correlative studies
510509|NCT00731692|B4|Baseline|Total|Total of all reporting groups
510510|NCT00731692|B3|Baseline|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510511|NCT00731692|B2|Baseline|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510555|NCT00731692|E3|Reported Event|Core: Placebo|Patients who received Placebo during core
510513|NCT00731692|P3|Participant Flow|Placebo to -FTY 0.5 mg|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510514|NCT00731692|P2|Participant Flow|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510515|NCT00731692|P1|Participant Flow|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
510516|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510517|NCT00731692|O1|Outcome|FTY720 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510518|NCT00731692|O3|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510519|NCT00731692|O2|Outcome|FTY720 1.25mg to 0.5 mg|fingolimod 1.25mg/0.5 mg group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg
510520|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
510521|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510522|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510523|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
510524|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510525|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510526|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
510527|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510528|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510529|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
510530|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510531|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510532|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
510533|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510534|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510535|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
510536|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510537|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510538|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510539|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510540|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510541|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510542|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510543|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510544|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510545|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510546|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510547|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510548|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510549|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510550|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
510551|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
510552|NCT00731692|E6|Reported Event|Extension: Placebo-FTY0.5|Patients who received Placebo in core and received 0.5 mg of FTY during Extension
510553|NCT00731692|E5|Reported Event|Extension: FTY0.5-0.5|Patients who received FTY20 0.5 mg in core and received 0.5 mg of FTY during Extension
510554|NCT00731692|E4|Reported Event|Extension: FTY1.25-0.5|Patients who received FTY20 1.25 mg in core and received 0.5 mg of FTY during Extension
510559|NCT00731679|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510560|NCT00731679|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510561|NCT00731679|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510562|NCT00731679|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510563|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510564|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510565|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510566|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510567|NCT00731679|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510568|NCT00731679|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
510569|NCT00731666|B1|Baseline|Titan® IPP|Subjects implanted with Titan® IPP
510570|NCT00731666|P1|Participant Flow|Titan® IPP|Subjects implanted with Titan® IPP
510571|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
510572|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
510573|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
510574|NCT00731666|E1|Reported Event|Titan® IPP|Subjects implanted with Titan® IPP
510575|NCT00731653|B1|Baseline|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
510576|NCT00731653|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
510577|NCT00731653|O1|Outcome|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
510578|NCT00731653|E1|Reported Event|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
510579|NCT00731640|B3|Baseline|Total|Total of all reporting groups
510580|NCT00731640|B2|Baseline|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
510581|NCT00731640|B1|Baseline|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
510582|NCT00731640|P2|Participant Flow|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
510583|NCT00731640|P1|Participant Flow|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
510584|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
510585|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
510586|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
510587|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
510588|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
510589|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
510590|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
510591|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
510592|NCT00731640|E2|Reported Event|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
510593|NCT00731640|E1|Reported Event|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
510594|NCT00731614|B3|Baseline|Total|Total of all reporting groups
510595|NCT00731614|B2|Baseline|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
510596|NCT00731614|B1|Baseline|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
510597|NCT00731614|P2|Participant Flow|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
510661|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
526189|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
510598|NCT00731614|P1|Participant Flow|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
510599|NCT00731614|O2|Outcome|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
510600|NCT00731614|O1|Outcome|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
510601|NCT00731614|E2|Reported Event|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
510602|NCT00731614|E1|Reported Event|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
510603|NCT00731549|B1|Baseline|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510604|NCT00731549|P1|Participant Flow|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510605|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510606|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510607|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510608|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510609|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510610|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510611|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510612|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510613|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510662|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510663|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510614|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510615|NCT00731549|E1|Reported Event|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
510616|NCT00731484|B1|Baseline|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
510617|NCT00731484|P1|Participant Flow|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
510618|NCT00731484|O1|Outcome|General Population|Subjects were recruited from patients presenting for a routine visit at the physician office study sites
510619|NCT00731484|E1|Reported Event|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
510620|NCT00731341|B1|Baseline|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510621|NCT00731341|P1|Participant Flow|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510622|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510623|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510624|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510625|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510626|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510627|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510628|NCT00731341|E1|Reported Event|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
510629|NCT00731211|B1|Baseline|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
510630|NCT00731211|P1|Participant Flow|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
510631|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
510632|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
510633|NCT00731211|E1|Reported Event|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
510634|NCT00731198|B3|Baseline|Total|Total of all reporting groups
510635|NCT00731198|B2|Baseline|Active Comparator|Hyoscine-N-butylbromide
510636|NCT00731198|B1|Baseline|Experimental|Drotaverine hydrochloride
510637|NCT00731198|P2|Participant Flow|Active Comparator|Hyoscine-N-butylbromide
510638|NCT00731198|P1|Participant Flow|Experimental|Drotaverine hydrochloride
510639|NCT00731198|O2|Outcome|Active Comparator|Hyoscine-N-butylbromide
510640|NCT00731198|O1|Outcome|Experimental|Drotaverine hydrochloride
510641|NCT00731198|E2|Reported Event|Active Comparator|Hyoscine-N-butylbromide
510642|NCT00731198|E1|Reported Event|Experimental|Drotaverine hydrochloride
510643|NCT00731133|B1|Baseline|Disulfiram|Disulfiram at 250 mg daily
510644|NCT00731133|P1|Participant Flow|Disulfiram|Disulfiram at 250 mg daily
510645|NCT00731133|O1|Outcome|Disulfiram 250 mg|
510646|NCT00731133|O1|Outcome|Disulfiram 250 mg|
510647|NCT00731133|E1|Reported Event|Disulfiram|Disulfiram at 250 mg daily
510648|NCT00731120|B4|Baseline|Total|Total of all reporting groups
510649|NCT00731120|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510650|NCT00731120|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510651|NCT00731120|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510652|NCT00731120|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510653|NCT00731120|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510654|NCT00731120|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510655|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510656|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510657|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510658|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510659|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510664|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510665|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510666|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510667|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510668|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510669|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510670|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510671|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510672|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510673|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510674|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510675|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510676|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510677|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510678|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510679|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510680|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510681|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510682|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510683|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510684|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510685|NCT00731120|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
510686|NCT00731120|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
510687|NCT00731120|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
510688|NCT00731094|B3|Baseline|Total|Total of all reporting groups
510689|NCT00731094|B2|Baseline|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510690|NCT00731094|B1|Baseline|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510691|NCT00731094|P2|Participant Flow|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510692|NCT00731094|P1|Participant Flow|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510693|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510694|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510695|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510696|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510697|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510698|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
526190|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
510699|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510700|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510701|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510702|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510703|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510704|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510705|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510706|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510707|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510708|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510709|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510710|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510711|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510712|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510713|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510714|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510715|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510716|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510717|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510881|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510718|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510719|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510720|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510721|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510722|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510723|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510724|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510725|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510726|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510727|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510728|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510729|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510730|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510731|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510732|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510733|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510734|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510735|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510786|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
510839|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
510736|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510737|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510738|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510739|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510740|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510741|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510742|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510743|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510744|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510745|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510746|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510747|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510748|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510749|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510750|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510751|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510752|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510753|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510787|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
510840|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
510754|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510755|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510756|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510757|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510758|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510759|NCT00731094|E2|Reported Event|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
510760|NCT00731094|E1|Reported Event|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
510761|NCT00731055|B1|Baseline|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
510762|NCT00731055|P1|Participant Flow|Study Participants|This is a within-group study design, all participant who completed the study receive all 4 experimental treatments
510763|NCT00731055|O4|Outcome|Varenicline 2.0 mg|The outcome of the session during which participant received varenicline 2.0 mg
510764|NCT00731055|O3|Outcome|Varenicline 1.0 mg|The outcome of the session during which participant received varenicline 1.0 mg
510765|NCT00731055|O2|Outcome|Varenicline 0.5 mg|The outcome of the session during which participant received varenicline 0.5 mg
510766|NCT00731055|O1|Outcome|Placebo|The outcome of the session during which participant received placebo
510767|NCT00731055|E1|Reported Event|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
510768|NCT00731042|B3|Baseline|Total|Total of all reporting groups
510769|NCT00731042|B2|Baseline|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
510770|NCT00731042|B1|Baseline|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
510771|NCT00731042|P2|Participant Flow|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
510772|NCT00731042|P1|Participant Flow|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
510773|NCT00731042|O2|Outcome|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
510774|NCT00731042|O1|Outcome|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
510775|NCT00731042|E2|Reported Event|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
510776|NCT00731042|E1|Reported Event|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
510777|NCT00730964|B1|Baseline|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
510778|NCT00730964|P1|Participant Flow|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
510779|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
510780|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product.
510781|NCT00730964|E1|Reported Event|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
510782|NCT00730925|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
510783|NCT00730925|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
510784|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
510785|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
510880|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510788|NCT00730925|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
510789|NCT00730912|B4|Baseline|Total|Total of all reporting groups
510790|NCT00730912|B3|Baseline|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
510791|NCT00730912|B2|Baseline|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
510792|NCT00730912|B1|Baseline|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
510793|NCT00730912|P3|Participant Flow|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
510794|NCT00730912|P2|Participant Flow|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
510795|NCT00730912|P1|Participant Flow|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
510796|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
510797|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
510798|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
510799|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
510800|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
510801|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
510802|NCT00730912|E3|Reported Event|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
510803|NCT00730912|E2|Reported Event|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
510804|NCT00730912|E1|Reported Event|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
510805|NCT00730847|B1|Baseline|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
510806|NCT00730847|P1|Participant Flow|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
510807|NCT00730847|O1|Outcome|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
510808|NCT00730847|O1|Outcome|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
510809|NCT00730847|O1|Outcome|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
510810|NCT00730847|O1|Outcome|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
510811|NCT00730847|E1|Reported Event|Cervarix Group|Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
510812|NCT00730756|B3|Baseline|Total|Total of all reporting groups
510813|NCT00730756|B2|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510814|NCT00730756|B1|Baseline|Placebo|Vehicle placebo nasal spray once daily
510815|NCT00730756|P2|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510816|NCT00730756|P1|Participant Flow|Placebo|Vehicle placebo nasal spray once daily
510817|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510818|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510819|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510820|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510821|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510822|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510823|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510824|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510825|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510826|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510827|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510828|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510829|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510830|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510831|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510832|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510833|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510834|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
510835|NCT00730756|E2|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
510836|NCT00730756|E1|Reported Event|Placebo|Vehicle placebo nasal spray once daily
510837|NCT00730730|B1|Baseline|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
510838|NCT00730730|P1|Participant Flow|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
510841|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
510842|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
510843|NCT00730730|E1|Reported Event|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
510844|NCT00730691|B6|Baseline|Total|Total of all reporting groups
510845|NCT00730691|B5|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510846|NCT00730691|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510847|NCT00730691|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510848|NCT00730691|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510849|NCT00730691|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510850|NCT00730691|P5|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510851|NCT00730691|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510852|NCT00730691|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510853|NCT00730691|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510854|NCT00730691|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510855|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510856|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510857|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510858|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510859|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510860|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510861|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510862|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510863|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510864|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510865|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510866|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510867|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510868|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510869|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510870|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510871|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510872|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510873|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510874|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510875|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510876|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510877|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510878|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510879|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510882|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510883|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510884|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510885|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510886|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510887|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510888|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510889|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510890|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510891|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510892|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510893|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510894|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510895|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510896|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510897|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510898|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510899|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510900|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510901|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510902|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510903|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510904|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510905|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510906|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510907|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510908|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510909|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510910|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510911|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510912|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510913|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510914|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510915|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510916|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510917|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510918|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510919|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510920|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
511116|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
510921|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510922|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510923|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510924|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510925|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510926|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510927|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510928|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510929|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510930|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510931|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510932|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510933|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510934|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510935|NCT00730691|E5|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
510936|NCT00730691|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510937|NCT00730691|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
510938|NCT00730691|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
510939|NCT00730691|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
510940|NCT00730639|B6|Baseline|Total|Total of all reporting groups
510941|NCT00730639|B5|Baseline|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510942|NCT00730639|B4|Baseline|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510943|NCT00730639|B3|Baseline|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510944|NCT00730639|B2|Baseline|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510945|NCT00730639|B1|Baseline|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510946|NCT00730639|P5|Participant Flow|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
510947|NCT00730639|P4|Participant Flow|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
510948|NCT00730639|P3|Participant Flow|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
510949|NCT00730639|P2|Participant Flow|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
510984|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
511117|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
526191|NCT00699608|O1|Outcome|Placebo|Placebo
510950|NCT00730639|P1|Participant Flow|0.1 mg/kg Nivolumab|0.1 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg)was administered intravenously (IV) every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, partial response (PR), or stable disease (SD), who subsequently experienced confirmed PD.
510951|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510952|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510953|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510954|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510955|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510956|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510957|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510958|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510959|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510960|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510961|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510962|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510963|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510964|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510965|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510966|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510967|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510968|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510969|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510970|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510971|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510972|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510973|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510974|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510975|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510976|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510977|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510978|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510979|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510980|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
510981|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510982|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510983|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
526192|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
510985|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510986|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510987|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510988|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510989|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510990|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510991|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510992|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
510993|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510994|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510995|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510996|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510997|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510998|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
510999|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511000|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511001|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511002|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511003|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511004|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511005|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511006|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511007|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511008|NCT00730639|E5|Reported Event|10 mg/kg Nivolumab|IV solution of 10 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511009|NCT00730639|E4|Reported Event|3 mg/kg Nivolumab|IV solution of 3 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511010|NCT00730639|E3|Reported Event|1 mg/kg Nivolumab|IV solution of 1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511011|NCT00730639|E2|Reported Event|0.3 mg/kg Nivolumab|IV solution of 0.3 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511012|NCT00730639|E1|Reported Event|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
511013|NCT00730483|B1|Baseline|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
511014|NCT00730483|P1|Participant Flow|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
511015|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
511016|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
511017|NCT00730483|O1|Outcome|Single Arm|PVA microporous hydrospheres/doxorubicin hydrochloride
511018|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
511019|NCT00730483|O1|Outcome|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
511020|NCT00730483|E1|Reported Event|Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)|Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
511021|NCT00730405|B6|Baseline|Total|Total of all reporting groups
511022|NCT00730405|B5|Baseline|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511023|NCT00730405|B4|Baseline|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511024|NCT00730405|B3|Baseline|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511025|NCT00730405|B2|Baseline|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511026|NCT00730405|B1|Baseline|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511027|NCT00730405|P5|Participant Flow|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511080|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511028|NCT00730405|P4|Participant Flow|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511029|NCT00730405|P3|Participant Flow|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511030|NCT00730405|P2|Participant Flow|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511031|NCT00730405|P1|Participant Flow|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 milligrams (mg) of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511032|NCT00730405|O5|Outcome|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511033|NCT00730405|O4|Outcome|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511034|NCT00730405|O3|Outcome|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511035|NCT00730405|O2|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511036|NCT00730405|O1|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511037|NCT00730405|O5|Outcome|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511038|NCT00730405|O4|Outcome|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511039|NCT00730405|O3|Outcome|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511040|NCT00730405|O2|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511041|NCT00730405|O1|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511042|NCT00730405|O5|Outcome|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511043|NCT00730405|O4|Outcome|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511044|NCT00730405|O3|Outcome|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511045|NCT00730405|O2|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511046|NCT00730405|O1|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511047|NCT00730405|O5|Outcome|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511048|NCT00730405|O4|Outcome|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511049|NCT00730405|O3|Outcome|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511050|NCT00730405|O2|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511051|NCT00730405|O1|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511114|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511115|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511052|NCT00730405|O5|Outcome|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511053|NCT00730405|O4|Outcome|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511054|NCT00730405|O3|Outcome|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511055|NCT00730405|O2|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511056|NCT00730405|O1|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511057|NCT00730405|O5|Outcome|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511058|NCT00730405|O4|Outcome|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511059|NCT00730405|O3|Outcome|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511060|NCT00730405|O2|Outcome|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511061|NCT00730405|O1|Outcome|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511062|NCT00730405|E5|Reported Event|Placebo|Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511063|NCT00730405|E4|Reported Event|Albaconazole 100 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511079|NCT00730327|P1|Participant Flow|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
526193|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
511064|NCT00730405|E3|Reported Event|Albaconazole 200 mg (36 Weeks) Oral Weekly|Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511065|NCT00730405|E2|Reported Event|Albaconazole 400 mg (24 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511066|NCT00730405|E1|Reported Event|Albaconazole 400 mg (36 Weeks) Oral Weekly|Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
511067|NCT00730353|B1|Baseline|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511068|NCT00730353|P1|Participant Flow|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511069|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511070|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511071|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511072|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511073|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511074|NCT00730353|E1|Reported Event|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
511075|NCT00730327|B3|Baseline|Total|Total of all reporting groups
511076|NCT00730327|B2|Baseline|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511077|NCT00730327|B1|Baseline|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511078|NCT00730327|P2|Participant Flow|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
515259|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
511081|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511082|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511083|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511084|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511085|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511086|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511087|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511088|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511089|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511090|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511091|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511092|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511093|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511094|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511095|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511096|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511097|NCT00730327|E2|Reported Event|Control|Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
511098|NCT00730327|E1|Reported Event|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
511099|NCT00730275|B5|Baseline|Total|Total of all reporting groups
511100|NCT00730275|B4|Baseline|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
511101|NCT00730275|B3|Baseline|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511102|NCT00730275|B2|Baseline|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511103|NCT00730275|B1|Baseline|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511104|NCT00730275|P4|Participant Flow|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
511105|NCT00730275|P3|Participant Flow|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511106|NCT00730275|P2|Participant Flow|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511107|NCT00730275|P1|Participant Flow|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511108|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
511109|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511110|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511111|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511112|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511113|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511118|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511119|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511120|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511121|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511122|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511123|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511124|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
511125|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511126|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511127|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511128|NCT00730275|E4|Reported Event|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
511129|NCT00730275|E3|Reported Event|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
511130|NCT00730275|E2|Reported Event|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
511131|NCT00730275|E1|Reported Event|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
511132|NCT00730236|B1|Baseline|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511133|NCT00730236|P1|Participant Flow|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511134|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511135|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511136|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511137|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511138|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511139|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511140|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511141|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511142|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511143|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511144|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511145|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511146|NCT00730236|E1|Reported Event|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
511147|NCT00730171|B1|Baseline|Overall Safety Population|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
511168|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
511148|NCT00730171|P1|Participant Flow|Overal Safey Population: Total|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator’s discretion.
511149|NCT00730171|O3|Outcome|Overall Safety Population: Total|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
511150|NCT00730171|O2|Outcome|IBS-C Safety Population: Total|RI and RO participants who met the Rome II criteria for IBS-C and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
511151|NCT00730171|O1|Outcome|CC Safety Population: Total|RI and RO participants who met the Rome II criteria for CC and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
511152|NCT00730171|E3|Reported Event|Overall Safety Population: Total|All RI and RO participants who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
511153|NCT00730171|E2|Reported Event|IBS-C Safety Population: Total|RI and RO participants who met the modified Rome II criteria for IBS-C and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
511154|NCT00730171|E1|Reported Event|CC Safety Population: Total|RI and RO participants who met the modified Rome II criteria for CC and who received linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
511155|NCT00730132|B1|Baseline|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
511156|NCT00730132|P1|Participant Flow|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
511157|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
511158|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
511159|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
511160|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
511161|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
511162|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
511163|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
511164|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
511165|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
511166|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
511167|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
511269|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511169|NCT00730132|O1|Outcome|All Participants Analyzed|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C. A participant was included in the study in case the lipid lowering therapy was modified in one of the following options: 1- statin dose (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) titration, 2- administration of a new statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin), 3- administration of ezetimibe in addition to current statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) therapy.
511170|NCT00730132|E1|Reported Event|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
511171|NCT00730041|B3|Baseline|Total|Total of all reporting groups
511172|NCT00730041|B2|Baseline|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511173|NCT00730041|B1|Baseline|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511174|NCT00730041|P2|Participant Flow|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511175|NCT00730041|P1|Participant Flow|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511176|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511177|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511178|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511179|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511180|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511181|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511182|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511183|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511184|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511185|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511186|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511187|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511188|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511189|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511190|NCT00730041|E2|Reported Event|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
511191|NCT00730041|E1|Reported Event|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
511192|NCT00730028|B6|Baseline|Total|Total of all reporting groups
511193|NCT00730028|B5|Baseline|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511194|NCT00730028|B4|Baseline|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511195|NCT00730028|B3|Baseline|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511196|NCT00730028|B2|Baseline|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511197|NCT00730028|B1|Baseline|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511198|NCT00730028|P5|Participant Flow|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511199|NCT00730028|P4|Participant Flow|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511270|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511200|NCT00730028|P3|Participant Flow|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511201|NCT00730028|P2|Participant Flow|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511202|NCT00730028|P1|Participant Flow|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511203|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511204|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511205|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511206|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511207|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511208|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511209|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511210|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511211|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511212|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511213|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511214|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511215|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511216|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511271|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511272|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511273|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511217|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511218|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511219|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511220|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511221|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511222|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511223|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511224|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511225|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511226|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511227|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511228|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511229|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511230|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511231|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511232|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511233|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511234|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511235|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511236|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511237|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511238|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
511239|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511240|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511241|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511242|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511243|NCT00730028|E5|Reported Event|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
511244|NCT00730028|E4|Reported Event|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511245|NCT00730028|E3|Reported Event|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511246|NCT00730028|E2|Reported Event|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
511247|NCT00730028|E1|Reported Event|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
511248|NCT00730015|B4|Baseline|Total|Total of all reporting groups
511249|NCT00730015|B3|Baseline|Placebo|Dose matched placebo, oral administration, once per day
511250|NCT00730015|B2|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511251|NCT00730015|B1|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511252|NCT00730015|P3|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day
511253|NCT00730015|P2|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511254|NCT00730015|P1|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511255|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511256|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511257|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511258|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511259|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511260|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511261|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511262|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511263|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511264|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511265|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511266|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511267|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511268|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
526194|NCT00699608|O1|Outcome|Placebo|Placebo
511274|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511275|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511276|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
511277|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
511278|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
511279|NCT00730015|E8|Reported Event|Linaclotide 290μg to Linaclotide 290μg RW Period|Linaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day
511280|NCT00730015|E7|Reported Event|Linaclotide 290μg to Placebo RW Period|Linaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
511281|NCT00730015|E6|Reported Event|Linaclotide 145μg to Linaclotide 145μg RW Period|Linaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day
511282|NCT00730015|E5|Reported Event|Linaclotide 145μg to Placebo RW Period|Linaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
511283|NCT00730015|E4|Reported Event|Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period|Dose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.
511284|NCT00730015|E3|Reported Event|Placebo|Dose matched placebo, oral administration, once per day
511285|NCT00730015|E2|Reported Event|Linaclotide 290μg|Linaclotide, 290μg dose, oral administration, once per day
511286|NCT00730015|E1|Reported Event|Linaclotide 145μg|Linaclotide, 145μg dose, oral administration, once per day
511287|NCT00729937|B7|Baseline|Total|Total of all reporting groups
511288|NCT00729937|B6|Baseline|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511289|NCT00729937|B5|Baseline|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511290|NCT00729937|B4|Baseline|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511291|NCT00729937|B3|Baseline|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511292|NCT00729937|B2|Baseline|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511293|NCT00729937|B1|Baseline|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511294|NCT00729937|P6|Participant Flow|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511295|NCT00729937|P5|Participant Flow|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511296|NCT00729937|P4|Participant Flow|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511297|NCT00729937|P3|Participant Flow|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511298|NCT00729937|P2|Participant Flow|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511299|NCT00729937|P1|Participant Flow|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511300|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511301|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511302|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511303|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511304|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511305|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511306|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511307|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511308|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511309|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511310|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511311|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511312|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511313|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511314|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511315|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511316|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511317|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511318|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511319|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511320|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511321|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511322|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511323|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511324|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511325|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511326|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511327|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511328|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511329|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511330|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511331|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511332|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511333|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511334|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511335|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511336|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511337|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511338|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511339|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511340|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511341|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
526195|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
511342|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511343|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511344|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511345|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511346|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511347|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511348|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511349|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511350|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511351|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511352|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511353|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511354|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511355|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511356|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511357|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511358|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511359|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511360|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511361|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511362|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511363|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511364|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511365|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511366|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511367|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511368|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511369|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511370|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511371|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511372|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511404|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511373|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511374|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511375|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511376|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511377|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511378|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511379|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511380|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511381|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511382|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511383|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511384|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511385|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511386|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511387|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511388|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511389|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511390|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511391|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511392|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511393|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511394|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511395|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511396|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511397|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511398|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511399|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511400|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511401|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511402|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511403|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511989|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511405|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511406|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511407|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511408|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511409|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511410|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511411|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511412|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511413|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511414|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511415|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511416|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511417|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511418|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511419|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511420|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511421|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511422|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511423|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511424|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511425|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511426|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511427|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511428|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511429|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511430|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511431|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511432|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511433|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511434|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511435|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511990|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511436|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511437|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511438|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511439|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511440|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511441|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511442|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511443|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511444|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511445|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511446|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511447|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511448|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511449|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511450|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511451|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511452|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511453|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511454|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511455|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511456|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511457|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511458|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511459|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511460|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511461|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511462|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511463|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511464|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511465|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511466|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511467|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
526196|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
511468|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511469|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511470|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511471|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511472|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511473|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511474|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511475|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511476|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511477|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511478|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511479|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511480|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511481|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511482|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511483|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511484|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511485|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511486|NCT00729937|E6|Reported Event|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
511487|NCT00729937|E5|Reported Event|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511488|NCT00729937|E4|Reported Event|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
511489|NCT00729937|E3|Reported Event|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
511490|NCT00729937|E2|Reported Event|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
511491|NCT00729937|E1|Reported Event|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
511492|NCT00729924|B1|Baseline|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
511493|NCT00729924|P1|Participant Flow|Raltegravir 400mg Orally Every 12 Hours for 7 Days.|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
511494|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
511495|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
511496|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
511497|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
511498|NCT00729924|E1|Reported Event|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
511499|NCT00729859|B4|Baseline|Total|Total of all reporting groups
511500|NCT00729859|B3|Baseline|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
511501|NCT00729859|B2|Baseline|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
511502|NCT00729859|B1|Baseline|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
511503|NCT00729859|P3|Participant Flow|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
511504|NCT00729859|P2|Participant Flow|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
511505|NCT00729859|P1|Participant Flow|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
511506|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511507|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511508|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511509|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511510|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511511|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511512|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511513|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511514|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511515|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511516|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511517|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511518|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511519|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511520|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511521|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511522|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511523|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511524|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511525|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511526|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511527|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
511528|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511529|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511530|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrazole pill 1 mg for 28 days
511531|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511532|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511533|NCT00729859|O3|Outcome|Group 3: Acyline + T-gel + Oral Anastrozole 1mg|Acyline SQ inj. Day 0 & 14 + T-gel and anastrozole for 28 days
511534|NCT00729859|O2|Outcome|Group 2: Acyline + T-gel 10g/Day + Placebo Pill|Acyline SQ inj. Day 0 & 14 + T-gel and placebo pill for 28 days
511535|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel + Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
511536|NCT00729859|E3|Reported Event|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
526197|NCT00699608|O1|Outcome|Placebo|Placebo
511537|NCT00729859|E2|Reported Event|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
511538|NCT00729859|E1|Reported Event|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
511539|NCT00729846|B3|Baseline|Total|Total of all reporting groups
511540|NCT00729846|B2|Baseline|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
511541|NCT00729846|B1|Baseline|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
511542|NCT00729846|P2|Participant Flow|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
511543|NCT00729846|P1|Participant Flow|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
511544|NCT00729846|O2|Outcome|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
511545|NCT00729846|O1|Outcome|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
511546|NCT00729846|E2|Reported Event|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
511547|NCT00729846|E1|Reported Event|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
511548|NCT00729833|B1|Baseline|Figitumumab + Sunitinib (All Combined)|All participants who received at least one dose of figitumumab plus sunitinib.
511549|NCT00729833|P4|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of continuous daily dosing followed by 1 week off, until disease progression or unacceptable toxicity.
511550|NCT00729833|P3|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
511551|NCT00729833|P2|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
511552|NCT00729833|P1|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab (CP-751,871) 10 milligram/kilogram (mg/kg) intravenous (IV) on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participant experienced a dose-limiting toxicity (DLT).
511553|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
511554|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511555|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511556|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
511557|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
511558|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511559|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511560|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
511561|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511562|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511563|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511564|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511565|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511566|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511567|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511568|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511569|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
511570|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
511571|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511572|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511573|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
511574|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
511575|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511576|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511577|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
511578|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
511579|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511580|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511581|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
511582|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
511583|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511584|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511585|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
511586|NCT00729833|E4|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
511587|NCT00729833|E3|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511588|NCT00729833|E2|Reported Event|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
511589|NCT00729833|E1|Reported Event|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
511590|NCT00729807|B1|Baseline|Treatment Arm|
511591|NCT00729807|P1|Participant Flow|Treatment Arm|
511592|NCT00729807|O1|Outcome|Treatment Arm|Pentamidine
511593|NCT00729807|E1|Reported Event|Treatment Arm|Pentamidine
511594|NCT00729781|B1|Baseline|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
511595|NCT00729781|P1|Participant Flow|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
511596|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
511597|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
511598|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
511599|NCT00729781|E1|Reported Event|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
511600|NCT00729690|B4|Baseline|Total|Total of all reporting groups
511601|NCT00729690|B3|Baseline|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
511602|NCT00729690|B2|Baseline|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
511603|NCT00729690|B1|Baseline|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
511604|NCT00729690|P3|Participant Flow|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
511605|NCT00729690|P2|Participant Flow|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
511606|NCT00729690|P1|Participant Flow|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
511607|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
511608|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
511609|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
511610|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
511611|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
511612|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
511613|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
511614|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
511615|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
511616|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
511617|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
511618|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
511991|NCT00729326|E2|Reported Event|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511619|NCT00729690|E3|Reported Event|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
511620|NCT00729690|E2|Reported Event|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
511621|NCT00729690|E1|Reported Event|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
511622|NCT00729677|B1|Baseline|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
511623|NCT00729677|P1|Participant Flow|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
511624|NCT00729677|O2|Outcome|Participants on 3-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
511625|NCT00729677|O1|Outcome|Participants on 2-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
511626|NCT00729677|O2|Outcome|Participants With No History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had no history of nausea.
511627|NCT00729677|O1|Outcome|Participants With History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had history of nausea.
511628|NCT00729677|O1|Outcome|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
511629|NCT00729677|O3|Outcome|Transgender|transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
511630|NCT00729677|O2|Outcome|Males|males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
511631|NCT00729677|O1|Outcome|Females|females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
511632|NCT00729677|E1|Reported Event|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
511633|NCT00729651|B3|Baseline|Total|Total of all reporting groups
511634|NCT00729651|B2|Baseline|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
511635|NCT00729651|B1|Baseline|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
511636|NCT00729651|P2|Participant Flow|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
511637|NCT00729651|P1|Participant Flow|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
511638|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511639|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511640|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511641|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511642|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511643|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511689|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
512395|NCT00727857|E3|Reported Event|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
511644|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511645|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
511646|NCT00729651|E2|Reported Event|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
511647|NCT00729651|E1|Reported Event|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
511648|NCT00729612|B1|Baseline|Treatment (Nab-paclitaxel, Carboplatin)|"Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~carboplatin~paclitaxel albumin-stabilized nanoparticle formulation~protein expression analysis~immunoenzyme technique~immunohistochemistry staining method~laboratory biomarker analysis"
511649|NCT00729612|P1|Participant Flow|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
511650|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
511651|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
511652|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
511653|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
511654|NCT00729612|E1|Reported Event|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
511655|NCT00729560|B1|Baseline|Flutamide Treated and Placebo Control|Flutamide treated: 250 mg twice daily for 4 weeks or Placebo control: twice daily for 4 weeks. Study was terminated due to insufficient enrollment. Randomization is unknown as study was terminated prior to unblinding and no key can be found. Consequently, we are unable to differentiate between treated and control subjects.
511656|NCT00729560|P1|Participant Flow|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
511657|NCT00729560|O1|Outcome|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
511658|NCT00729560|E1|Reported Event|Flutamide Treated and Placebo Control Subjects|Flutamide: 250 mg twice daily for 4 weeks or Placebo: twice daily for 4 weeks
511659|NCT00729521|B4|Baseline|Total|Total of all reporting groups
511660|NCT00729521|B3|Baseline|Facilitative System|"a Facilitative System group of five communities and their residents over 65 years of age receiving support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
511661|NCT00729521|B2|Baseline|Standard Program|"a Standard Program group of five communities and their residents over 65 years of age receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
511662|NCT00729521|B1|Baseline|Control|a control group of 10 communities and their residents over 65 years of age receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
511690|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511691|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511992|NCT00729326|E1|Reported Event|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511663|NCT00729521|P3|Participant Flow|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
511664|NCT00729521|P2|Participant Flow|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
511665|NCT00729521|P1|Participant Flow|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
511666|NCT00729521|O3|Outcome|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
511667|NCT00729521|O2|Outcome|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
511668|NCT00729521|O1|Outcome|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
511669|NCT00729521|E3|Reported Event|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
511670|NCT00729521|E2|Reported Event|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
511671|NCT00729521|E1|Reported Event|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
511672|NCT00729482|B1|Baseline|RAD001|Treatment Arm (RAD001)
511673|NCT00729482|P1|Participant Flow|RAD001|Treatment Arm (RAD001)
511674|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
511675|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
511676|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
511677|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
511678|NCT00729482|E1|Reported Event|RAD001|Treatment Arm (RAD001)
511679|NCT00729469|B3|Baseline|Total|Total of all reporting groups
511680|NCT00729469|B2|Baseline|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511681|NCT00729469|B1|Baseline|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511682|NCT00729469|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511683|NCT00729469|P1|Participant Flow|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511684|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511685|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511686|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511687|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511688|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511692|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511693|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511694|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511695|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511696|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511697|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511698|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511699|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511700|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511701|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511702|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511703|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511704|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511705|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511706|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511707|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511708|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511709|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511710|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511711|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511712|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511713|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511714|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511715|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511716|NCT00729469|E2|Reported Event|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511717|NCT00729469|E1|Reported Event|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
511718|NCT00729430|B3|Baseline|Total|Total of all reporting groups
511719|NCT00729430|B2|Baseline|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
511720|NCT00729430|B1|Baseline|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
511721|NCT00729430|P2|Participant Flow|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
526198|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
511722|NCT00729430|P1|Participant Flow|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
511723|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
511724|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
511725|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
511726|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
511727|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
511728|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
511729|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
511730|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
511731|NCT00729430|E2|Reported Event|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
511732|NCT00729430|E1|Reported Event|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
511733|NCT00729378|B3|Baseline|Total|Total of all reporting groups
511734|NCT00729378|B2|Baseline|Control|Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
511735|NCT00729378|B1|Baseline|Exercise Intervention|"Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511736|NCT00729378|P2|Participant Flow|Control|Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
511737|NCT00729378|P1|Participant Flow|Exercise Intervention|"Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511738|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511739|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511740|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511741|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511742|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511743|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511744|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511745|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511746|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511747|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511748|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511749|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511750|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511751|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511752|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511753|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511754|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511755|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511756|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511757|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511758|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511774|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
515260|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
511759|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511760|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511761|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511762|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511763|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511764|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511765|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511766|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511767|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511768|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511769|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511770|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511771|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511772|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511773|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511775|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511776|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511777|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511778|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511779|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511780|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511781|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511782|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511783|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511784|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511785|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511786|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511787|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511788|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511789|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511790|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511791|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511792|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511793|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511794|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511795|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511796|NCT00729378|O2|Outcome|Control Group|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511797|NCT00729378|O1|Outcome|Exercise Intervention Group|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511798|NCT00729378|O2|Outcome|Control Group|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511799|NCT00729378|O1|Outcome|Exercise Intervention Group|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511800|NCT00729378|O2|Outcome|Control Group|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511801|NCT00729378|O1|Outcome|Exercise Intervention Group|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511802|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511803|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511804|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511820|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
526199|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
511805|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511806|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511807|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511808|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511809|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511810|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511811|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511812|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511813|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511814|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511815|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511816|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511817|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511818|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511819|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511821|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511822|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511823|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511824|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511825|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511826|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511827|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511828|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511829|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511830|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511831|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511832|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511833|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511834|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511835|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511836|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511837|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511838|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511839|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511840|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511841|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511842|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511843|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511844|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511845|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511846|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511847|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511848|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511849|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511850|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511866|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
515261|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
511851|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511852|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511853|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511854|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511855|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511856|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511857|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511858|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511859|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511860|NCT00729378|O2|Outcome|Control Group|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511861|NCT00729378|O1|Outcome|Exercise Intervention Group|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511862|NCT00729378|O2|Outcome|Control Group|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511863|NCT00729378|O1|Outcome|Exercise Intervention Group|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511864|NCT00729378|O2|Outcome|Control Group|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511865|NCT00729378|O1|Outcome|Exercise Intervention Group|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511867|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511868|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511869|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511870|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511871|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511872|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511873|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511874|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511875|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511876|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511877|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511878|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511879|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511880|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511881|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511882|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511883|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511884|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511885|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511886|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511887|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511888|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511889|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511890|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511891|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511892|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511893|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511894|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511895|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511896|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511912|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
515262|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
511897|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511898|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511899|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511900|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511901|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511902|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511903|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511904|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511905|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511906|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511907|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511908|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511909|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511910|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511911|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511913|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511914|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511915|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511916|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511917|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511918|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511919|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511920|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511921|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511922|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511923|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511924|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511925|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511926|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511927|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511928|NCT00729378|O2|Outcome|Control|Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
511929|NCT00729378|O1|Outcome|Exercise Intervention|"Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.~Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ)."
511930|NCT00729378|E2|Reported Event|Control Arm|Participants in this arm will not take part in intervention exercises. All activities performed by subjects in control arm will be assessed by physical activity questionnaire and use of pedometer.
511931|NCT00729378|E1|Reported Event|Exercise Intervention Arm|"Implementation of intervention program designed to provide skeletal loading through high impact activities.~Skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities will be introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years."
511932|NCT00729365|B4|Baseline|Total|Total of all reporting groups
511933|NCT00729365|B3|Baseline|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
511934|NCT00729365|B2|Baseline|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
511935|NCT00729365|B1|Baseline|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
511936|NCT00729365|P3|Participant Flow|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
511937|NCT00729365|P2|Participant Flow|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
511938|NCT00729365|P1|Participant Flow|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
511939|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
511940|NCT00729365|O2|Outcome|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
511941|NCT00729365|O1|Outcome|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
511942|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
511943|NCT00729365|O2|Outcome|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
511944|NCT00729365|O1|Outcome|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
511945|NCT00729365|E3|Reported Event|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
511946|NCT00729365|E2|Reported Event|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
511988|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511947|NCT00729365|E1|Reported Event|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
511948|NCT00729326|B3|Baseline|Total|Total of all reporting groups
511949|NCT00729326|B2|Baseline|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511950|NCT00729326|B1|Baseline|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511951|NCT00729326|P2|Participant Flow|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511952|NCT00729326|P1|Participant Flow|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511953|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511954|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511955|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511956|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511957|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511958|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511959|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511960|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511961|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511962|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511963|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511964|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511965|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511966|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511967|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511968|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511969|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511970|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511971|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511972|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511973|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511974|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511975|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511976|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511977|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511978|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511979|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511980|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511981|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511982|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511983|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511984|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511985|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
511986|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
511987|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
526200|NCT00699608|O1|Outcome|Placebo|Placebo
511993|NCT00729248|B1|Baseline|All Participants|"All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
511994|NCT00729248|P1|Participant Flow|Participants|12 participants were recruited/consented for the study. 2 subjects (donor/recipient pair) were withdrawn from the study. Ten participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
511995|NCT00729248|O2|Outcome|MLRs in the Presence of SRL|"All participants (5 donors, 5 recipietns) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in teh following combination:~Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
511996|NCT00729248|O1|Outcome|MLRs in the Presence of TAC|"All participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~REcipient PMBC + Donor PBMC + Tacrolimus (TAC)"
511997|NCT00729248|E1|Reported Event|All Participants|All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
511998|NCT00729183|B3|Baseline|Total|Total of all reporting groups
511999|NCT00729183|B2|Baseline|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512000|NCT00729183|B1|Baseline|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512001|NCT00729183|P2|Participant Flow|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512002|NCT00729183|P1|Participant Flow|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512003|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512004|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512005|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512006|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512007|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512008|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512009|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512010|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512011|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512012|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512013|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512014|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512015|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512016|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512017|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512018|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512019|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512020|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512021|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512022|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512023|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512024|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512025|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512026|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512027|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512028|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512029|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512030|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512031|NCT00729183|E2|Reported Event|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512032|NCT00729183|E1|Reported Event|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
512033|NCT00729157|B1|Baseline|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512034|NCT00729157|P1|Participant Flow|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512035|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512055|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512056|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512057|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512036|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512037|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512038|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512039|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512040|NCT00729157|E1|Reported Event|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
512041|NCT00728988|B3|Baseline|Total|Total of all reporting groups
512042|NCT00728988|B2|Baseline|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512043|NCT00728988|B1|Baseline|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512044|NCT00728988|P2|Participant Flow|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512045|NCT00728988|P1|Participant Flow|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512046|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512047|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512048|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512049|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
512050|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512051|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
512052|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512053|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512054|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512058|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512059|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512060|NCT00728988|E2|Reported Event|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
512061|NCT00728988|E1|Reported Event|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
512062|NCT00728962|B1|Baseline|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
512063|NCT00728962|P1|Participant Flow|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
512064|NCT00728962|O1|Outcome|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
512065|NCT00728962|E1|Reported Event|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
512066|NCT00728923|B1|Baseline|Minocycline|minocycline 100mg bid for 12 weeks
512067|NCT00728923|P1|Participant Flow|Minocycline|minocycline 100mg bid for 12 weeks
512068|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
512069|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
512070|NCT00728923|E1|Reported Event|Minocycline|minocycline 100mg bid for 12 weeks
512071|NCT00728910|B1|Baseline|Group 1|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks.
512072|NCT00728910|P1|Participant Flow|Atorvastatin/ABT335/Niaspan|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks, for a total study duration of 22 weeks
512073|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks followed by an oral fat tolerance test.
512074|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks followed by an oral fat tolerance test.
512075|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by an oral fat tolerance test
512076|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
512077|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
512078|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
512079|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
512080|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
512081|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
512082|NCT00728910|E1|Reported Event|Atorvastatin/ABT335/Niaspan|Subjects received atorvastatin 10 mg/day for 4 weeks, followed by addition of ABT335 135 mg/day for a further 8 weeks followed by the addition of Niaspan 2000 mg/day for a further 10 weeks.
512083|NCT00728884|B1|Baseline|Certain Prevail Implants|Osseotite surfaced implants with internal connection
512084|NCT00728884|P1|Participant Flow|Certain Prevail Implants|Osseotite surfaced implants with internal connection
512085|NCT00728884|O1|Outcome|Certain Prevail Implants|Osseotite surfaced implants with internal connection
512086|NCT00728884|E1|Reported Event|Certain Prevail Implants|Osseotite surfaced implants with internal connection
512087|NCT00728845|B3|Baseline|Total|Total of all reporting groups
512088|NCT00728845|B2|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512089|NCT00728845|B1|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512090|NCT00728845|P2|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512091|NCT00728845|P1|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512092|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512093|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512126|NCT00728728|B3|Baseline|Total|Total of all reporting groups
512127|NCT00728728|B2|Baseline|Arm 2: Placebo|Placebo control group
512094|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512095|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512096|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512097|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512098|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512099|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512100|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512101|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512102|NCT00728845|E2|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512103|NCT00728845|E1|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
512104|NCT00728819|B3|Baseline|Total|Total of all reporting groups
512105|NCT00728819|B2|Baseline|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512106|NCT00728819|B1|Baseline|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512107|NCT00728819|P2|Participant Flow|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512108|NCT00728819|P1|Participant Flow|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512109|NCT00728819|O2|Outcome|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512110|NCT00728819|O1|Outcome|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512111|NCT00728819|O2|Outcome|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512112|NCT00728819|O1|Outcome|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512113|NCT00728819|O2|Outcome|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512114|NCT00728819|O1|Outcome|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512115|NCT00728819|E2|Reported Event|Non-tapered PICC|"Non-tapered PICC~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512116|NCT00728819|E1|Reported Event|Taper PICC|"Tapered PICC~Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins~Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins"
512117|NCT00728754|B3|Baseline|Total|Total of all reporting groups
512118|NCT00728754|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
512119|NCT00728754|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
512120|NCT00728754|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
512121|NCT00728754|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
512122|NCT00728754|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
512123|NCT00728754|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
512124|NCT00728754|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
512125|NCT00728754|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
512128|NCT00728728|B1|Baseline|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512129|NCT00728728|P2|Participant Flow|Arm 2: Placebo|Placebo control group
512130|NCT00728728|P1|Participant Flow|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512131|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
512132|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512133|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
512134|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512135|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
512136|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512137|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo: Placebo
512138|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512139|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
512140|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512141|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
512142|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512143|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
512144|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
512145|NCT00728728|E2|Reported Event|Arm 2: Placebo|"Placebo~Placebo: Placebo"
512146|NCT00728728|E1|Reported Event|Arm 1: Pregnenolone|"Pregnenolone~Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial."
512147|NCT00728689|B3|Baseline|Total|Total of all reporting groups
512148|NCT00728689|B2|Baseline|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
512149|NCT00728689|B1|Baseline|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
512150|NCT00728689|P2|Participant Flow|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
512151|NCT00728689|P1|Participant Flow|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
512152|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512153|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512154|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512155|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512156|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512157|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512158|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512159|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512160|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512161|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512162|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
512343|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
515263|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
512163|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
512164|NCT00728689|E2|Reported Event|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512165|NCT00728689|E1|Reported Event|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
512166|NCT00728507|B3|Baseline|Total|Total of all reporting groups
512167|NCT00728507|B2|Baseline|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
512168|NCT00728507|B1|Baseline|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
512169|NCT00728507|P2|Participant Flow|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
512170|NCT00728507|P1|Participant Flow|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
512171|NCT00728507|O2|Outcome|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
512172|NCT00728507|O1|Outcome|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
512173|NCT00728507|O2|Outcome|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
512174|NCT00728507|O1|Outcome|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
512175|NCT00728507|E2|Reported Event|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
512176|NCT00728507|E1|Reported Event|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
512177|NCT00728494|B3|Baseline|Total|Total of all reporting groups
512178|NCT00728494|B2|Baseline|Treatment Alone|PegIntron/Rebetol treatment only
512179|NCT00728494|B1|Baseline|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512180|NCT00728494|P2|Participant Flow|Treatment Alone|PegIntron/Rebetol treatment only
512181|NCT00728494|P1|Participant Flow|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512182|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
512183|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512184|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
512185|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512186|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
512260|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512187|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512188|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
512189|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512190|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
512191|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512192|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
512193|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
512194|NCT00728494|E2|Reported Event|Treatment Alone|
512195|NCT00728494|E1|Reported Event|Treatment and Patient Assistance Program|
512196|NCT00728481|B3|Baseline|Total|Total of all reporting groups
512197|NCT00728481|B2|Baseline|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512198|NCT00728481|B1|Baseline|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512199|NCT00728481|P2|Participant Flow|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512200|NCT00728481|P1|Participant Flow|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512201|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512202|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512203|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512204|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512205|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512206|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512207|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512208|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512209|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512210|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512211|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512212|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512213|NCT00728481|E2|Reported Event|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
512214|NCT00728481|E1|Reported Event|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
512215|NCT00728468|B1|Baseline|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512216|NCT00728468|P1|Participant Flow|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512344|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512217|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512218|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512219|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512220|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512221|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512222|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512223|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512224|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512225|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512226|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512227|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512228|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512229|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512230|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512231|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512232|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512233|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512234|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512235|NCT00728468|O1|Outcome|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512261|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
515264|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
512236|NCT00728468|E1|Reported Event|PF-00299804 45 mg + Dextromethorphan 30 mg|PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
512237|NCT00728416|B3|Baseline|Total|Total of all reporting groups
512238|NCT00728416|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
512239|NCT00728416|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
512240|NCT00728416|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
512241|NCT00728416|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
512242|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
512243|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
512244|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
512245|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
512246|NCT00728416|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
512247|NCT00728416|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
512248|NCT00728260|B1|Baseline|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
512249|NCT00728260|P1|Participant Flow|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
512250|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
512251|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
512252|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
512253|NCT00728260|E1|Reported Event|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
512254|NCT00728182|B3|Baseline|Total|Total of all reporting groups
512255|NCT00728182|B2|Baseline|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512256|NCT00728182|B1|Baseline|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512257|NCT00728182|P2|Participant Flow|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512258|NCT00728182|P1|Participant Flow|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512259|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512299|NCT00727961|E1|Reported Event|Caelyx Intravenous|
512345|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512262|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512263|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512264|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512265|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512266|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512267|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512268|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512269|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512270|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512271|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512272|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512273|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512274|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512275|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512276|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512277|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512278|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512279|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512280|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512281|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512282|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512283|NCT00728182|E2|Reported Event|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
512284|NCT00728182|E1|Reported Event|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
512285|NCT00728130|B1|Baseline|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
512286|NCT00728130|P1|Participant Flow|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
512287|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
512288|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
512289|NCT00728130|E1|Reported Event|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
512290|NCT00727961|B1|Baseline|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512291|NCT00727961|P1|Participant Flow|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512292|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512293|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512294|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512295|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512296|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512297|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512298|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
512300|NCT00727909|B1|Baseline|All Study Participants|All study participants received all three hearing aid treatments (TC, RITA, RITE). The sequence of treatments was counter-balanced to prevent an order effect. Each hearing aid treatment lasted two months. Each treatment period was followed by the administration of a series of outcome measures before the next treatment was begun. At the conclusion of the third treatment, in addition to administration of the outcome measures, the participants were asked to rank the three hearing aid treatments in order of preference, and to provide subjective comments regarding the rationale for their rank-ordering.
512301|NCT00727909|P4|Participant Flow|RITA RITE TC|Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months.
512302|NCT00727909|P3|Participant Flow|RITE RITA TC|Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months.
512303|NCT00727909|P2|Participant Flow|TC RITA RITE|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months.
512304|NCT00727909|P1|Participant Flow|TC RITE RITA|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months.
512305|NCT00727909|O1|Outcome|All Participants|All participants received all three hearing aid treatments.
512306|NCT00727909|E1|Reported Event|All Study Participants|All participants received all three hearing aid treatments.
512307|NCT00727857|B4|Baseline|Total|Total of all reporting groups
512308|NCT00727857|B3|Baseline|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512309|NCT00727857|B2|Baseline|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512310|NCT00727857|B1|Baseline|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512311|NCT00727857|P3|Participant Flow|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512312|NCT00727857|P2|Participant Flow|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512313|NCT00727857|P1|Participant Flow|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512314|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512315|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512316|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg/Metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512317|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512318|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512319|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512320|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512321|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512322|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512323|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512324|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512325|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512326|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512327|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512328|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512329|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512330|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512331|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512332|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512333|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512334|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512335|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512336|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512337|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512338|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512339|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512340|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512341|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512342|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
515265|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
512346|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512347|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512348|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512349|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512350|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512351|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512352|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512353|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512354|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512355|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512356|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512357|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512358|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512359|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512360|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512361|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512362|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512363|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512364|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512365|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512366|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512367|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512368|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512369|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512370|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512371|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512372|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512373|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512374|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512375|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512376|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512377|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512378|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512379|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512380|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512381|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512382|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512383|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512384|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512385|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512386|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512387|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512388|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512389|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512390|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512391|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512392|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
512393|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512394|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
526201|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
512396|NCT00727857|E2|Reported Event|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
512397|NCT00727857|E1|Reported Event|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
512398|NCT00727844|B3|Baseline|Total|Total of all reporting groups
512399|NCT00727844|B2|Baseline|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
512400|NCT00727844|B1|Baseline|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
512401|NCT00727844|P4|Participant Flow|2nd Randomization: Linezolid 300 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
512402|NCT00727844|P3|Participant Flow|2nd Randomization: Linezolid 600 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
512403|NCT00727844|P2|Participant Flow|Initial Randomization: Delayed Start Linezolid|Subjects continued their existing treatment regimen for 2 additional months after which linezolid 600 mg once daily was added.
512404|NCT00727844|P1|Participant Flow|Initial Randomization: Immediate Start Linezolid|Upon completion of entry criteria, subjects immediately added linezolid 600 mg once daily to their ongoing TB treatment regimen.
512405|NCT00727844|O2|Outcome|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
512406|NCT00727844|O1|Outcome|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
512407|NCT00727844|E1|Reported Event|Clinically Significant AEs|All clinically significant adverse events, regardless of relationship to linezolid. This includes all SAEs, all AEs grade 3 and above, and all neuropathies grade 2 and above.
512408|NCT00727740|B3|Baseline|Total|Total of all reporting groups
512409|NCT00727740|B2|Baseline|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
512410|NCT00727740|B1|Baseline|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
512411|NCT00727740|P2|Participant Flow|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
512412|NCT00727740|P1|Participant Flow|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
512435|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
512510|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
515266|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
512413|NCT00727740|O2|Outcome|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
512414|NCT00727740|O1|Outcome|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
512415|NCT00727740|E2|Reported Event|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
512416|NCT00727740|E1|Reported Event|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
512417|NCT00727714|B1|Baseline|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512418|NCT00727714|P1|Participant Flow|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512419|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512420|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512421|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512422|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512423|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512424|NCT00727714|E1|Reported Event|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
512425|NCT00727649|B3|Baseline|Total|Total of all reporting groups
512426|NCT00727649|B2|Baseline|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg pill~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
512427|NCT00727649|B1|Baseline|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy"
512428|NCT00727649|P2|Participant Flow|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
512429|NCT00727649|P1|Participant Flow|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
512430|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
512431|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
512432|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
512433|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
512434|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
512436|NCT00727649|E4|Reported Event|L1P2 (Psyllium Second); 2nd 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
512437|NCT00727649|E3|Reported Event|P1L2 (Loperamide Second); 2nd 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
512438|NCT00727649|E2|Reported Event|L1P2 (Loperamide First): 1st 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
512439|NCT00727649|E1|Reported Event|P1L2 (Psyllium First); 1st 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
512440|NCT00727636|B3|Baseline|Total|Total of all reporting groups
512441|NCT00727636|B2|Baseline|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
512442|NCT00727636|B1|Baseline|Prospective Cohort|Received Gardasil as part of study
512443|NCT00727636|P2|Participant Flow|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
512444|NCT00727636|P1|Participant Flow|Prospective Cohort|Received Gardasil as part of study
512445|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
512446|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
512447|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
512448|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
512449|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
512450|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
512451|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
512452|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
512453|NCT00727636|E2|Reported Event|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
512454|NCT00727636|E1|Reported Event|Prospective Cohort|Received Gardasil as part of study
512455|NCT00727597|B3|Baseline|Total|Total of all reporting groups
512456|NCT00727597|B2|Baseline|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
512457|NCT00727597|B1|Baseline|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
512458|NCT00727597|P2|Participant Flow|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
512459|NCT00727597|P1|Participant Flow|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
512460|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
512461|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
512462|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
512463|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
512464|NCT00727597|E2|Reported Event|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
512465|NCT00727597|E1|Reported Event|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
512466|NCT00727571|B5|Baseline|Total|Total of all reporting groups
512467|NCT00727571|B4|Baseline|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512468|NCT00727571|B3|Baseline|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512469|NCT00727571|B2|Baseline|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512470|NCT00727571|B1|Baseline|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512471|NCT00727571|P4|Participant Flow|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
512472|NCT00727571|P3|Participant Flow|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
512509|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512473|NCT00727571|P2|Participant Flow|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
512474|NCT00727571|P1|Participant Flow|No CKD or Anemia|Chronic kidney disease (CKD) is based on an estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
512475|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512476|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512477|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512478|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512479|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512480|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512481|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512482|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512483|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512484|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512485|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512486|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512487|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512488|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512489|NCT00727571|O2|Outcome|No CKD But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512490|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512491|NCT00727571|O1|Outcome|All Enrolled Participants|
512492|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512493|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512494|NCT00727571|E4|Reported Event|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
512495|NCT00727571|E3|Reported Event|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512496|NCT00727571|E2|Reported Event|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512497|NCT00727571|E1|Reported Event|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
512498|NCT00727558|B3|Baseline|Total|Total of all reporting groups
512499|NCT00727558|B2|Baseline|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512500|NCT00727558|B1|Baseline|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512501|NCT00727558|P2|Participant Flow|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512502|NCT00727558|P1|Participant Flow|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512503|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512504|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512505|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512506|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512507|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512508|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512511|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512512|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512513|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512514|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512515|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512516|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512517|NCT00727558|E2|Reported Event|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
512518|NCT00727558|E1|Reported Event|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
512519|NCT00727506|B7|Baseline|Total|Total of all reporting groups
512520|NCT00727506|B6|Baseline|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512521|NCT00727506|B5|Baseline|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512522|NCT00727506|B4|Baseline|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512523|NCT00727506|B3|Baseline|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512524|NCT00727506|B2|Baseline|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512525|NCT00727506|B1|Baseline|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512526|NCT00727506|P6|Participant Flow|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512527|NCT00727506|P5|Participant Flow|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512528|NCT00727506|P4|Participant Flow|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512529|NCT00727506|P3|Participant Flow|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512530|NCT00727506|P2|Participant Flow|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512531|NCT00727506|P1|Participant Flow|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512532|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512533|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512534|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512535|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512536|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512537|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512538|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512539|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512540|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512541|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512542|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512543|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512544|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512545|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512546|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512547|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512548|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512549|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512550|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512680|NCT00727259|E1|Reported Event|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
512551|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512552|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512553|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512554|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512555|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512556|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512557|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512558|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512559|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512560|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512561|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512562|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512563|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512564|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512565|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512566|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512567|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512568|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512569|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512570|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512571|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512572|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512573|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512574|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512575|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512576|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512577|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512578|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512579|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512580|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512581|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512582|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512583|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512584|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512585|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512586|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512587|NCT00727506|O1|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512588|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
512589|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
512590|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
512591|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
512592|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
512593|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
512594|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of Afatinib).
512595|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of Afatinib)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of Afatinib).
512596|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of temozolomide).
512597|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of temozolomide).
512598|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of temozolomide).
512599|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of temozolomide).
512600|NCT00727506|O2|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Absence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in absence of temozolomide).
512601|NCT00727506|O1|Outcome|Phase I - Afatinib 50mg+TMZ 75mg/m^2 (in Presence of TMZ)|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part (in presence of temozolomide).
512602|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512603|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512604|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512605|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512606|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512607|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512608|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512609|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512610|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512611|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512612|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512613|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512614|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512615|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512616|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512617|NCT00727506|E6|Reported Event|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part.
512618|NCT00727506|E5|Reported Event|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
512619|NCT00727506|E4|Reported Event|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
512620|NCT00727506|E3|Reported Event|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512621|NCT00727506|E2|Reported Event|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512622|NCT00727506|E1|Reported Event|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
512623|NCT00727402|B1|Baseline|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
512624|NCT00727402|P1|Participant Flow|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
512625|NCT00727402|O1|Outcome|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
512626|NCT00727402|E1|Reported Event|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
512627|NCT00727337|B5|Baseline|Total|Total of all reporting groups
512628|NCT00727337|B4|Baseline|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
512629|NCT00727337|B3|Baseline|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
512630|NCT00727337|B2|Baseline|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
512631|NCT00727337|B1|Baseline|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
512632|NCT00727337|P4|Participant Flow|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
512633|NCT00727337|P3|Participant Flow|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
512634|NCT00727337|P2|Participant Flow|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
512635|NCT00727337|P1|Participant Flow|LACE - COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
512636|NCT00727337|O4|Outcome|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
512637|NCT00727337|O3|Outcome|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
512638|NCT00727337|O2|Outcome|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
512639|NCT00727337|O1|Outcome|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
512640|NCT00727337|E4|Reported Event|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
512641|NCT00727337|E3|Reported Event|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
512642|NCT00727337|E2|Reported Event|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
512643|NCT00727337|E1|Reported Event|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
512644|NCT00727311|B1|Baseline|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
512645|NCT00727311|P1|Participant Flow|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
512646|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
512647|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
512648|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
512649|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
512650|NCT00727311|E1|Reported Event|All Participants|
512651|NCT00727298|B1|Baseline|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
512652|NCT00727298|P1|Participant Flow|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
512653|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
512654|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
512655|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
512656|NCT00727298|E1|Reported Event|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
512657|NCT00727272|B1|Baseline|Entire Study Population|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under Fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512658|NCT00727272|P3|Participant Flow|Treatment Sequence CAB|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512659|NCT00727272|P2|Participant Flow|Treatment Sequence BCA|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512660|NCT00727272|P1|Participant Flow|Treatment Sequence ABC|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512661|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
512662|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
512663|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
512664|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512665|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg 30 minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
512666|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
512667|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
512668|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512669|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
512670|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
512671|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
512672|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512673|NCT00727272|E3|Reported Event|Treatment C - Quinine Sulfate Capsules 324 mg - Fed|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512674|NCT00727272|E2|Reported Event|Treatment B - Quinine Sulphate Tablets 300 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512675|NCT00727272|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 324 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512676|NCT00727259|B1|Baseline|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940).
512677|NCT00727259|P1|Participant Flow|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
512678|NCT00727259|O2|Outcome|After 3 Months of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
512679|NCT00727259|O1|Outcome|After 1 Month of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
512682|NCT00727246|B4|Baseline|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
512683|NCT00727246|B3|Baseline|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
512684|NCT00727246|B2|Baseline|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
512685|NCT00727246|B1|Baseline|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
512686|NCT00727246|P4|Participant Flow|Control Participants Who Received Placebo|Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
512687|NCT00727246|P3|Participant Flow|Control Participants Who Received CDP-Choline|Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline
512688|NCT00727246|P2|Participant Flow|Participants With TBI Who Received Placebo|Participants with a history of TBI who were randomly assigned to the placebo group
512689|NCT00727246|P1|Participant Flow|Participants With TBI Who Received CDP-Choline|Participants who have experienced a TBI and were randomly assigned to receive the study supplement
512690|NCT00727246|O4|Outcome|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
512691|NCT00727246|O3|Outcome|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
512692|NCT00727246|O2|Outcome|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
512693|NCT00727246|O1|Outcome|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
512694|NCT00727246|O4|Outcome|Control Participants Who Received Placebo|Participants without a history of TBI who were randomized to receive placebo
512695|NCT00727246|O3|Outcome|Control Participants Who Received CDP-Choline|Participants without a history of TBI who were randomized to receive CDP-Choline
512696|NCT00727246|O2|Outcome|Participants With TBI Who Received Placebo|Participants with TBI who were randomized to receive Placebo
512697|NCT00727246|O1|Outcome|Participants With TBI Who Received CDP-Choline|Participants with TBI who were randomized to receive the CDP-Choline
512698|NCT00727246|E4|Reported Event|Control Participants Who Received Placebo|Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
512699|NCT00727246|E3|Reported Event|Control Participants Who Received CDP-Choline|Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline
512700|NCT00727246|E2|Reported Event|Participants With TBI Who Received Placebo|Participants with a history of TBI who were randomly assigned to the placebo group
512701|NCT00727246|E1|Reported Event|Participants With TBI Who Received CDP-Choline|Participants who have experienced a TBI and were randomly assigned to receive the study supplement
512702|NCT00727220|B3|Baseline|Total|Total of all reporting groups
512703|NCT00727220|B2|Baseline|Insulin Injections|
512704|NCT00727220|B1|Baseline|Insulin Pump Therapy|
512705|NCT00727220|P2|Participant Flow|Insulin Injections|
512706|NCT00727220|P1|Participant Flow|Insulin Pump Therapy|
512707|NCT00727220|O2|Outcome|Insulin Injections|
512708|NCT00727220|O1|Outcome|Insulin Pump Therapy|
512709|NCT00727220|E2|Reported Event|Insulin Injections|
512710|NCT00727220|E1|Reported Event|Insulin Pump Therapy|
512711|NCT00727194|B1|Baseline|Overall Study|"Eculizumab:~Eculizumab [600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)].~Period 1: patients received eculizumab for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received placebo for 16 weeks.~Placebo:~Matching placebo [IV weekly (4 doses) followed by IV every other week (7 doses)] Period 1: patients received placebo for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received eculizumab for 16 weeks."
512712|NCT00727194|P3|Participant Flow|Not Randomized/Screen Failures|Not randomized; not treatment cohort
512713|NCT00727194|P2|Participant Flow|Placebo to Eculizumab Sequence|"Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses).~Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses).~Period 1: patients received placebo for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received eculizumab for 16 weeks."
512714|NCT00727194|P1|Participant Flow|Eculizumab to Placebo Sequence|"Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)~Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses)~Period 1: patients received eculizumab for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received placebo for 16 weeks."
512715|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
512716|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
512717|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
512718|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
512719|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512720|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512721|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512722|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512723|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512724|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512725|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512726|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512727|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512728|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512729|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512730|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512731|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512732|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512733|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512734|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512735|NCT00727194|O4|Outcome|Placebo Period 2|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512736|NCT00727194|O3|Outcome|Eculizumab Period 2|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512737|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512738|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512739|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512740|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512741|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512742|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512743|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
512744|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
512745|NCT00727194|E2|Reported Event|Eculizumab|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
512746|NCT00727194|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
512747|NCT00727090|B3|Baseline|Total|Total of all reporting groups
512748|NCT00727090|B2|Baseline|Usual Medical Care|Usual care by the attending physician staff
512749|NCT00727090|B1|Baseline|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512750|NCT00727090|P2|Participant Flow|Usual Medical Care|Usual care by the attending physician staff
512751|NCT00727090|P1|Participant Flow|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512752|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
512753|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512754|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
512755|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512756|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
512757|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512758|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
512759|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512760|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
512761|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512762|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
512763|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512764|NCT00727090|E2|Reported Event|Usual Medical Care|Usual care by the attending physician staff
512765|NCT00727090|E1|Reported Event|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
512766|NCT00727064|B3|Baseline|Total|Total of all reporting groups
512767|NCT00727064|B2|Baseline|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
512768|NCT00727064|B1|Baseline|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
512769|NCT00727064|P2|Participant Flow|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
512879|NCT00726713|P1|Participant Flow|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512770|NCT00727064|P1|Participant Flow|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
512771|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
512772|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
512773|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
512774|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
512775|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
512776|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
512777|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
512778|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
512779|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
512780|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
512781|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
512782|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
512783|NCT00727064|E2|Reported Event|Venlafaxine Extended Release (VEN ER)|SAE or AE reported on VEN ER regardless of which arm or period of trial.
512784|NCT00727064|E1|Reported Event|Desvenlafaxine Succinate Sustained-Release (DVS SR)|SAE or AE reported on DVS SR regardless of which arm or period of trial.
512785|NCT00727025|B1|Baseline|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
512786|NCT00727025|P1|Participant Flow|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
512787|NCT00727025|O2|Outcome|Suture Closure|
512788|NCT00727025|O1|Outcome|Steri-strip Closure|
512789|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
512790|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
512791|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
512792|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
512793|NCT00727025|E2|Reported Event|Wounds Closed With Suture|wound segments closed with traditional suture
512794|NCT00727025|E1|Reported Event|Wounds Closed With Device|segment of wounds closed with steri-strip device
512795|NCT00726999|B3|Baseline|Total|Total of all reporting groups
512796|NCT00726999|B2|Baseline|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
512797|NCT00726999|B1|Baseline|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
512798|NCT00726999|P2|Participant Flow|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
512799|NCT00726999|P1|Participant Flow|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
512800|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
512801|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
512802|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
512803|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
512804|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
512805|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
512806|NCT00726999|E2|Reported Event|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
512807|NCT00726999|E1|Reported Event|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
512808|NCT00726986|B1|Baseline|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
512809|NCT00726986|P1|Participant Flow|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
512810|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
512811|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
512812|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
512813|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
512814|NCT00726986|E1|Reported Event|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
512880|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
512815|NCT00726895|B1|Baseline|Entire Study Population|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received either one Quinine Sulfate 324 mg capsule or two Quinine Sulfate 324 mg capsules following an overnight fast of at least 10 hours.
512816|NCT00726895|P2|Participant Flow|Quinine Sulfate Capsules 2 x 324 mg Dose Then 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512817|NCT00726895|P1|Participant Flow|Quinine Sulfate Capsules 1 x 324 mg Dose Then 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512818|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512819|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
512820|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512821|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512822|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
512823|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512824|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512825|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
512826|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512827|NCT00726895|E2|Reported Event|Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512828|NCT00726895|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
512829|NCT00726882|B1|Baseline|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
512830|NCT00726882|P1|Participant Flow|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
512831|NCT00726882|O1|Outcome|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
512832|NCT00726882|O2|Outcome|Participants From Study M10-351|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00696904/M10-351) involving ABT−333.~Participants received no treatment in this follow-up study."
512833|NCT00726882|O1|Outcome|Participants From Study M10-380|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00851890/M10-380) involving ABT−333.~Participants received no treatment in this follow-up study."
512834|NCT00726882|E1|Reported Event|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
512835|NCT00726830|B3|Baseline|Total|Total of all reporting groups
512836|NCT00726830|B2|Baseline|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
512837|NCT00726830|B1|Baseline|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
512838|NCT00726830|P2|Participant Flow|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
512839|NCT00726830|P1|Participant Flow|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
512840|NCT00726830|O2|Outcome|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
512841|NCT00726830|O1|Outcome|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
513180|NCT00725725|P3|Participant Flow|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
512842|NCT00726830|E2|Reported Event|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
512843|NCT00726830|E1|Reported Event|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
512844|NCT00726752|B1|Baseline|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512845|NCT00726752|P1|Participant Flow|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512846|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512847|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512848|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512849|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512850|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512851|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512852|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512853|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512854|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512855|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512975|NCT00726414|E1|Reported Event|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512856|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512857|NCT00726752|E1|Reported Event|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
512858|NCT00726739|B3|Baseline|Total|Total of all reporting groups
512859|NCT00726739|B2|Baseline|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
512860|NCT00726739|B1|Baseline|Arm I and III Crossover Group - LMI + Aldesleukin|"Includes 6 patients who progressed and crossed over from Arm II."
512861|NCT00726739|P2|Participant Flow|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
512862|NCT00726739|P1|Participant Flow|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
512863|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
512864|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II. Both KLH and DTH are tests assessing the ability to respond to immune therapy. These are independent tests and there is no bearing of KLH response on DTH response."
512865|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
512866|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
512867|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
512868|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
512869|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
512870|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
512871|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
512872|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
512873|NCT00726739|E2|Reported Event|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on arm I.
512874|NCT00726739|E1|Reported Event|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
512875|NCT00726713|B3|Baseline|Total|Total of all reporting groups
512876|NCT00726713|B2|Baseline|Placebo|Placebo one tablet twice a day
512877|NCT00726713|B1|Baseline|Metanx|Metanx one tablet twice a day
512878|NCT00726713|P2|Participant Flow|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
514466|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
512881|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512882|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
512883|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512884|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
512885|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512886|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
512887|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512888|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
512889|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512890|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
512891|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512892|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
512893|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512894|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
512895|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512896|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
512897|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512898|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
512899|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512900|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
512901|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
512902|NCT00726713|E2|Reported Event|Placebo|Placebo one tablet twice a day
512903|NCT00726713|E1|Reported Event|Metanx|Metanx one tablet twice a day
512904|NCT00726661|B3|Baseline|Total|Total of all reporting groups
512905|NCT00726661|B2|Baseline|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512906|NCT00726661|B1|Baseline|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512907|NCT00726661|P2|Participant Flow|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512908|NCT00726661|P1|Participant Flow|Chemotherapy Cohort|Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512909|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512910|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512911|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512912|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
513181|NCT00725725|P2|Participant Flow|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
512913|NCT00726661|O1|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512914|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512915|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512916|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512917|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512918|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512919|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512920|NCT00726661|E2|Reported Event|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512921|NCT00726661|E1|Reported Event|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
512922|NCT00726622|B3|Baseline|Total|Total of all reporting groups
512923|NCT00726622|B2|Baseline|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512924|NCT00726622|B1|Baseline|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512925|NCT00726622|P2|Participant Flow|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512926|NCT00726622|P1|Participant Flow|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512927|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512928|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512929|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512930|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512931|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512932|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512933|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512934|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512935|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512936|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512937|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512938|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512939|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
512940|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
512941|NCT00726622|E2|Reported Event|Arm 2: Laparoscopic-assisted Rectal Resection|Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
512942|NCT00726622|E1|Reported Event|Arm 1: Open Laparotomy and Rectal Resection|Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.
512943|NCT00726609|B1|Baseline|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
512944|NCT00726609|P1|Participant Flow|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
512945|NCT00726609|O1|Outcome|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
512946|NCT00726609|E1|Reported Event|Posaconazole (Assigned by Physician in Normal Practice)|
512947|NCT00726557|B1|Baseline|PegIntron + Rebetol|Baseline measures only available for the 118 participants who completed.
512948|NCT00726557|P1|Participant Flow|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
512949|NCT00726557|O1|Outcome|Participants Who Tolerated Treatment|Those who completed treatment.
512950|NCT00726557|O1|Outcome|Participants With Negative HCV-RNA at End of Treatment|End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4
512951|NCT00726557|E1|Reported Event|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
512952|NCT00726453|B3|Baseline|Total|Total of all reporting groups
512953|NCT00726453|B2|Baseline|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available.
512954|NCT00726453|B1|Baseline|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
526202|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
512955|NCT00726453|P2|Participant Flow|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
512956|NCT00726453|P1|Participant Flow|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
512957|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
512958|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
512959|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
512960|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
512961|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
512962|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
512963|NCT00726453|E2|Reported Event|38 mm Length Sub-Study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
512964|NCT00726453|E1|Reported Event|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG)."
512965|NCT00726414|B1|Baseline|Quinine Sulfate Under Fed and Fasted Conditions|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast or 30 minutes following a standardized, high fat breakfast.
512966|NCT00726414|P2|Participant Flow|Quinine Sulfate Under Fed Then Fasted Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
512967|NCT00726414|P1|Participant Flow|Quinine Sulfate Under Fasted Then Fed Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast.
512968|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
512969|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512970|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
512971|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512972|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
512973|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
512974|NCT00726414|E2|Reported Event|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
526203|NCT00699608|O1|Outcome|Placebo|Placebo
512976|NCT00726375|B1|Baseline|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
512977|NCT00726375|P1|Participant Flow|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
512978|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
512979|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
512980|NCT00726375|E1|Reported Event|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
512981|NCT00726323|B3|Baseline|Total|Total of all reporting groups
512982|NCT00726323|B2|Baseline|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512983|NCT00726323|B1|Baseline|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512984|NCT00726323|P2|Participant Flow|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512985|NCT00726323|P1|Participant Flow|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 milligrams (mg) on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512986|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512987|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512988|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512989|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512990|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512991|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513100|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
512992|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512993|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512994|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512995|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512996|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512997|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512998|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
512999|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513000|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513001|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513002|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513003|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513004|NCT00726323|O2|Outcome|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513005|NCT00726323|O1|Outcome|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
513006|NCT00726323|E2|Reported Event|Daily Dosing Regimen|Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up every 8 weeks for tumor assessment, while the participant remained in the treatment extension period.
513007|NCT00726323|E1|Reported Event|Intermittent 5 & 9 Dosing Regimen|Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up every 8 weeks for tumor assessment, while the participant remained in the treatment extension period.
513008|NCT00726232|B7|Baseline|Total|Total of all reporting groups
513009|NCT00726232|B6|Baseline|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513101|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513010|NCT00726232|B5|Baseline|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513011|NCT00726232|B4|Baseline|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513012|NCT00726232|B3|Baseline|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513013|NCT00726232|B2|Baseline|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513014|NCT00726232|B1|Baseline|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513015|NCT00726232|P6|Participant Flow|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513016|NCT00726232|P5|Participant Flow|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513017|NCT00726232|P4|Participant Flow|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513018|NCT00726232|P3|Participant Flow|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513019|NCT00726232|P2|Participant Flow|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513020|NCT00726232|P1|Participant Flow|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513021|NCT00726232|O6|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513022|NCT00726232|O5|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513102|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
514467|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
513023|NCT00726232|O4|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513024|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513025|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513026|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513027|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513028|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513029|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513030|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513031|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513032|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513033|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513034|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513035|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513036|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513037|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513038|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513039|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513040|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513041|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513042|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513043|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513044|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513045|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513046|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513047|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513048|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513049|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513050|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513051|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513052|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513053|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513054|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513055|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513056|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513057|NCT00726232|E6|Reported Event|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513058|NCT00726232|E5|Reported Event|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513059|NCT00726232|E4|Reported Event|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513060|NCT00726232|E3|Reported Event|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513061|NCT00726232|E2|Reported Event|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513062|NCT00726232|E1|Reported Event|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
513063|NCT00726180|B1|Baseline|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
513103|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513064|NCT00726180|P1|Participant Flow|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
513065|NCT00726180|O1|Outcome|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
513066|NCT00726180|E1|Reported Event|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
513067|NCT00726063|B3|Baseline|Total|Total of all reporting groups
513068|NCT00726063|B2|Baseline|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
513069|NCT00726063|B1|Baseline|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
513070|NCT00726063|P2|Participant Flow|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
513071|NCT00726063|P1|Participant Flow|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
513072|NCT00726063|O2|Outcome|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
513073|NCT00726063|O1|Outcome|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
513074|NCT00726063|E2|Reported Event|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
513075|NCT00726063|E1|Reported Event|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
513076|NCT00726037|B1|Baseline|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
513077|NCT00726037|P1|Participant Flow|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
513078|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
513079|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
513080|NCT00726037|E1|Reported Event|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
513081|NCT00725985|B4|Baseline|Total|Total of all reporting groups
513082|NCT00725985|B3|Baseline|Placebo|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
513083|NCT00725985|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
513084|NCT00725985|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
513104|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513085|NCT00725985|P12|Participant Flow|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513086|NCT00725985|P11|Participant Flow|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513087|NCT00725985|P10|Participant Flow|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513088|NCT00725985|P9|Participant Flow|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513089|NCT00725985|P8|Participant Flow|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513090|NCT00725985|P7|Participant Flow|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513091|NCT00725985|P6|Participant Flow|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
513092|NCT00725985|P5|Participant Flow|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
513093|NCT00725985|P4|Participant Flow|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
513094|NCT00725985|P3|Participant Flow|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513095|NCT00725985|P2|Participant Flow|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513096|NCT00725985|P1|Participant Flow|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
513097|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513098|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513099|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513176|NCT00725725|B4|Baseline|Total|Total of all reporting groups
513105|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513106|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513107|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513108|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513109|NCT00725985|E12|Reported Event|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513110|NCT00725985|E11|Reported Event|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513111|NCT00725985|E10|Reported Event|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513112|NCT00725985|E9|Reported Event|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513113|NCT00725985|E8|Reported Event|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513114|NCT00725985|E7|Reported Event|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
513115|NCT00725985|E6|Reported Event|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
513116|NCT00725985|E5|Reported Event|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
513117|NCT00725985|E4|Reported Event|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
513118|NCT00725985|E3|Reported Event|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513177|NCT00725725|B3|Baseline|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
515267|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
513119|NCT00725985|E2|Reported Event|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
513120|NCT00725985|E1|Reported Event|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
513121|NCT00725959|B3|Baseline|Total|Total of all reporting groups
513122|NCT00725959|B2|Baseline|Arm 2|Attention Control exposed to a current events Facebook page
513123|NCT00725959|B1|Baseline|Arm 1|Group exposed to dynamic content on Facebook re: HIV Prevention
513124|NCT00725959|P2|Participant Flow|Control Arm|Attention Control exposed to a current events Facebook page
513125|NCT00725959|P1|Participant Flow|Intervention Arm|Group exposed to dynamic content on Facebook re: HIV Prevention
513126|NCT00725959|O2|Outcome|Arm 2|
513127|NCT00725959|O1|Outcome|Arm 1|Group exposed to dynamic content on Facebook re: HIV Prevention
513128|NCT00725959|E2|Reported Event|Arm 2|Attention Control exposed to a current events Facebook page
513129|NCT00725959|E1|Reported Event|Arm 1|Group exposed to dynamic content on Facebook re: HIV Prevention
513130|NCT00725920|B3|Baseline|Total|Total of all reporting groups
513131|NCT00725920|B2|Baseline|Control Group|patients received pills content placebo, that were identical to the pills content active drug
513132|NCT00725920|B1|Baseline|Topiramate|patients receiving the active drug: topiramate
513133|NCT00725920|P2|Participant Flow|Control Group|patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
513134|NCT00725920|P1|Participant Flow|Topiramate|patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
513135|NCT00725920|O2|Outcome|Control Group|patients received pills content placebo, that were identical to the pills content active drug
513136|NCT00725920|O1|Outcome|Topiramate|patients receiving the active drug: topiramate
513137|NCT00725920|E2|Reported Event|Control Group|patients received pills content placebo, that were identical to the pills content active drug
513138|NCT00725920|E1|Reported Event|Topiramate|patients receiving the active drug: topiramate
513139|NCT00725842|B1|Baseline|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
513140|NCT00725842|P1|Participant Flow|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
513141|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
513142|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
513143|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
513144|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
513145|NCT00725842|E1|Reported Event|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
513146|NCT00725764|B1|Baseline|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513147|NCT00725764|P1|Participant Flow|Foretinib 240 mg|In each treatment period, participants received foretinib 240 milligram (mg) capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of progressive disease (PD) and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513178|NCT00725725|B2|Baseline|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513179|NCT00725725|B1|Baseline|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513148|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513149|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513150|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513151|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513152|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513153|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513154|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513155|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513156|NCT00725764|O1|Outcome|Foretinib 240 mg|This study consisted of a pre-treatment Period (screening and baseline evaluations), 8 week study treatment period, an optional treatment extension period, and a post-treatment period (including an end-of-treatment visit and an extended follow-up period). In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513157|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
526204|NCT00699608|E3|Reported Event|Zopiclone|7.5 mg Zopiclone
513158|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513159|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513160|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513161|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513162|NCT00725764|O1|Outcome|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513163|NCT00725764|E1|Reported Event|Foretinib 240 mg|In each treatment period, participants received foretinib 240 mg capsules orally on Days 1-5 of every 14-day cycle. Participants fasted 2 hours before to 1 hour after each dose. Each treatment cycle was 2 weeks. The 8-week study treatment period consisted of four 2-week treatment cycles. In the absence of PD and unacceptable toxicity, participants may have received foretinib treatment on the same dosing schedule for up to 1 year at the discretion of the investigator, and beyond 1 year with the approval of the sponsor while participating in this study. During the treatment extension period, participants continued to receive foretinib on Days 1 through 5 followed by a 9-day observation period.
513164|NCT00725751|B3|Baseline|Total|Total of all reporting groups
513165|NCT00725751|B2|Baseline|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513166|NCT00725751|B1|Baseline|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513167|NCT00725751|P2|Participant Flow|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513168|NCT00725751|P1|Participant Flow|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513169|NCT00725751|O1|Outcome|All Participants|"Participants who received at least one dose of antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)~Participants who received at least one dose of antiviral treatment and did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)"
513170|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513171|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513172|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513173|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513174|NCT00725751|E2|Reported Event|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513175|NCT00725751|E1|Reported Event|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
513182|NCT00725725|P1|Participant Flow|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513183|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513184|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513185|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513186|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513187|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513188|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513189|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513190|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513191|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513192|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513193|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513194|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513195|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513196|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513197|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513198|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513199|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513200|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513201|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513202|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513203|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513204|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513205|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513206|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513207|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513208|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513209|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513210|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513211|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513212|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513213|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513214|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513215|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513216|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513217|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513218|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513219|NCT00725725|E3|Reported Event|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
513220|NCT00725725|E2|Reported Event|Org 25935 12 mg|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
513221|NCT00725725|E1|Reported Event|Org 25935 4 mg|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
513222|NCT00725712|B3|Baseline|Total|Total of all reporting groups
513223|NCT00725712|B2|Baseline|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513288|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
515268|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
513224|NCT00725712|B1|Baseline|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513225|NCT00725712|P2|Participant Flow|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513226|NCT00725712|P1|Participant Flow|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 milligram (mg) per dosing day orally, on 5 days on and 9 days off cycle every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose
513227|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513228|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513229|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm
513230|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513231|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513232|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513233|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513234|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513235|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513236|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513237|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513238|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513239|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513289|NCT00725608|E1|Reported Event|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
514468|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
513240|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513241|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513242|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513243|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513244|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 & 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513245|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513246|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513247|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513248|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513249|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 and 9 dosing arm.
513250|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513251|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513252|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513253|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513254|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513255|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513318|NCT00725491|O2|Outcome|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
513319|NCT00725491|O1|Outcome|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
513256|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513257|NCT00725712|O2|Outcome|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 & 9 dosing arm.
513258|NCT00725712|O1|Outcome|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally( viz. foretinib solid capsules of 20, 100 and 200mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513259|NCT00725712|E2|Reported Event|GSK136308, Daily Dosing|The eligible participants in this arm were administered GSK1363089 at 80 mg daily for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose. The enrollment in this cohort was started until the enrollment completion in the Intermittent 5 and 9 dosing arm.
513260|NCT00725712|E1|Reported Event|GSK1363089, Intermittent 5 and 9 Dosing|The eligible participants in this arm were administered GSK1363089 at 240 mg per dosing day orally ( viz. foretinib solid capsules of 20, 100 and 200 mg) , as 5 days on and 9 days off cycle (no drug for 9-days) every 2 weeks for treatment period of 8 weeks. Participants fasted 2 hours before the dose, followed by a glass of water (after the intake of GSK1363089) and continued to fast 1 hour after each dose.
513261|NCT00725621|B1|Baseline|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513262|NCT00725621|P1|Participant Flow|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513263|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513264|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513265|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513266|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513267|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513268|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513269|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513270|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513320|NCT00725491|E2|Reported Event|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
513271|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513272|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513273|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513274|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513275|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513276|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513277|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513278|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513279|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513280|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513281|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513282|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513283|NCT00725621|E1|Reported Event|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
513284|NCT00725608|B1|Baseline|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
513285|NCT00725608|P1|Participant Flow|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
513286|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
513287|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
513290|NCT00725543|B1|Baseline|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513291|NCT00725543|P1|Participant Flow|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513292|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513293|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513294|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513295|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513296|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513297|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513298|NCT00725543|E1|Reported Event|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
513299|NCT00725530|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
513300|NCT00725530|P2|Participant Flow|Etafilcon A / Balafilcon A|Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
513301|NCT00725530|P1|Participant Flow|Balafilcon A / Etafilcon A|Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
513302|NCT00725530|O2|Outcome|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
513303|NCT00725530|O1|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
513304|NCT00725530|E2|Reported Event|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
513305|NCT00725530|E1|Reported Event|Balafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
513306|NCT00725504|B1|Baseline|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.~Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
513307|NCT00725504|P1|Participant Flow|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.~Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
513308|NCT00725504|O4|Outcome|Lidocaine 5 µg/ml|Each participant received an intravenous infusion of 5 µg/ml of lidocaine.
513309|NCT00725504|O3|Outcome|Lidocaine 3 µg/ml|Each participant received an intravenous infusion of 3 µg/ml of lidocaine.
513310|NCT00725504|O2|Outcome|Placebo|Each participant received a placebo-saline infusion.
513311|NCT00725504|O1|Outcome|Baseline|Each participant was tested at the zero infusion rate.
513312|NCT00725504|E1|Reported Event|Lidocaine Infusion|Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
513313|NCT00725491|B3|Baseline|Total|Total of all reporting groups
513314|NCT00725491|B2|Baseline|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
513315|NCT00725491|B1|Baseline|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
513316|NCT00725491|P2|Participant Flow|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
513317|NCT00725491|P1|Participant Flow|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
513321|NCT00725491|E1|Reported Event|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
513322|NCT00725452|B1|Baseline|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513323|NCT00725452|P1|Participant Flow|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513324|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513325|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513326|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513327|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513328|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513329|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513330|NCT00725452|E1|Reported Event|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
513331|NCT00725361|B1|Baseline|Active|"Ambrisentan~Ambrisentan"
513332|NCT00725361|P1|Participant Flow|Ambrisentan|5 mg orally daily X 4 weeks then 10 mg daily as tolerated
513333|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
513334|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
513335|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
513336|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
513337|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
513338|NCT00725361|E1|Reported Event|Active|"Ambrisentan~Ambrisentan"
513339|NCT00725322|B3|Baseline|Total|Total of all reporting groups
513340|NCT00725322|B2|Baseline|Botox Then Placebo|"Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue~Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma"
513341|NCT00725322|B1|Baseline|Placebo Then Botox|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue"
513342|NCT00725322|P2|Participant Flow|Botox Then Placebo|"Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue~Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
513343|NCT00725322|P1|Participant Flow|Placebo Then Botox|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
513344|NCT00725322|O2|Outcome|Botox|Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
513345|NCT00725322|O1|Outcome|Placebo|Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma
513346|NCT00725322|O2|Outcome|Botox|Botulinum Toxin A: Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
513347|NCT00725322|O1|Outcome|Placebo|Placebo - Saline: Subcutaneous Saline injection given at site of scar neuroma
513348|NCT00725322|E2|Reported Event|Botox Then Placebo|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
513349|NCT00725322|E1|Reported Event|Placebo Then Botox|"Placebo - Saline:~Subcutaneous Saline injection given at site of scar neuroma~Botulinum Toxin A:~Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue Both scar neuroma and scar tissue are locations of cutaneous allodynia in participants. In other words, both injections were in areas where the participant already had pain. Both injections were subcutaneous, right under the skin."
513350|NCT00725296|B1|Baseline|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
514412|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
513351|NCT00725296|P1|Participant Flow|Infliximab|Participants with active and progressive psoriatic arthritis (PsA) who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513352|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513353|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513354|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513355|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513356|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513357|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513358|NCT00725296|E1|Reported Event|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
513359|NCT00725270|B3|Baseline|Total|Total of all reporting groups
513360|NCT00725270|B2|Baseline|Mifepristone|Patients will be randomized to mifepristone
513361|NCT00725270|B1|Baseline|Placebo|Patients will be randomized to placebo
513362|NCT00725270|P2|Participant Flow|Mifepristone|Patients will be randomized to mifepristone
513363|NCT00725270|P1|Participant Flow|Placebo|Patients will be randomized to placebo
513364|NCT00725270|O2|Outcome|Mifepristone|Patients will be randomized to mifepristone
513365|NCT00725270|O1|Outcome|Placebo|Patients will be randomized to placebo
513366|NCT00725270|O2|Outcome|Mifepristone|Patients will be randomized to mifepristone
513367|NCT00725270|O1|Outcome|Placebo|Patients will be randomized to placebo
513368|NCT00725270|E2|Reported Event|Mifepristone|Patients will be randomized to mifepristone
513369|NCT00725270|E1|Reported Event|Placebo|Patients will be randomized to placebo
513443|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
514469|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
513370|NCT00725205|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
513371|NCT00725205|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
513372|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
513373|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
513374|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
513375|NCT00725205|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
513376|NCT00725153|B1|Baseline|Overall|All enrolled participants
513377|NCT00725153|P2|Participant Flow|Acuvue 2 / PureVision|Acuvue 2 lenses worn in Period One, PureVision lenses worn in Period Two. Both products worn for 10 hours each.
513378|NCT00725153|P1|Participant Flow|PureVision / Acuvue 2|PureVision lenses worn in Period One, Acuvue 2 lenses worn in Period Two. Both products worn for 10 hours each.
513379|NCT00725153|O2|Outcome|Acuvue 2 Contact Lenses|Acuvue 2 lenses worn 10 hours
513380|NCT00725153|O1|Outcome|PureVision Contact Lenses|PureVision lenses worn 10 hours
513381|NCT00725153|E2|Reported Event|Acuvue 2 Lenses Worn 10 Hours|Acuvue 2 lenses worn 10 hours
513382|NCT00725153|E1|Reported Event|PureVision Lenses Worn 10 Hours|PureVision lenses worn 10 hours
513383|NCT00725101|B1|Baseline|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513384|NCT00725101|P1|Participant Flow|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513385|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513386|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513387|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513388|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513389|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513390|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513391|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513392|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513393|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513394|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513395|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513396|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513397|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513398|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513399|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513400|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513401|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513402|NCT00725101|E1|Reported Event|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
513403|NCT00725075|B4|Baseline|Total|Total of all reporting groups
513404|NCT00725075|B3|Baseline|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513516|NCT00724932|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513517|NCT00724932|P2|Participant Flow|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)
513405|NCT00725075|B2|Baseline|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513406|NCT00725075|B1|Baseline|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513407|NCT00725075|P3|Participant Flow|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513408|NCT00725075|P2|Participant Flow|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513409|NCT00725075|P1|Participant Flow|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513410|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513411|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513412|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513413|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513414|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513415|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513416|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513417|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513418|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513419|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513420|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513421|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513422|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513423|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
515269|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
513424|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513425|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513426|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513427|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513428|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513429|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513430|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513431|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513432|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513433|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513434|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513435|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513436|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513437|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513438|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513439|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513440|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513441|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513442|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
515270|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
513444|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513445|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513446|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513447|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513448|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513449|NCT00725075|E3|Reported Event|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
513450|NCT00725075|E2|Reported Event|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513451|NCT00725075|E1|Reported Event|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
513452|NCT00725049|B3|Baseline|Total|Total of all reporting groups
513453|NCT00725049|B2|Baseline|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
513454|NCT00725049|B1|Baseline|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
513455|NCT00725049|P2|Participant Flow|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
513456|NCT00725049|P1|Participant Flow|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
513457|NCT00725049|O2|Outcome|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
513458|NCT00725049|O1|Outcome|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
513459|NCT00725049|E2|Reported Event|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
513460|NCT00725049|E1|Reported Event|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
513461|NCT00725010|B1|Baseline|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
513462|NCT00725010|P1|Participant Flow|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
513463|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
513464|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
513465|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
513518|NCT00724932|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 Post Tetanic Count (PTC)
513466|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
513467|NCT00725010|E2|Reported Event|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
513468|NCT00725010|E1|Reported Event|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
513469|NCT00724984|B7|Baseline|Total|Total of all reporting groups
513470|NCT00724984|B6|Baseline|Mantle Cell Lymphoma/Phase II|
513471|NCT00724984|B5|Baseline|Follicular/Phase II|
513472|NCT00724984|B4|Baseline|Cohort 4(60 mg/m2,7days/wk)/Phase 1|
513473|NCT00724984|B3|Baseline|Cohort 3(45 mg/m2, 7days/wk)/Phase 1|
513474|NCT00724984|B2|Baseline|Cohort 2(45 mg/m2, 5days/wk)/Phase 1|
513475|NCT00724984|B1|Baseline|Cohort 1(30 mg/m2, 5days/wk)/Phase 1|
513476|NCT00724984|P6|Participant Flow|Mantle Cell Lymphoma/Phase II|
513477|NCT00724984|P5|Participant Flow|Follicular/Phase II|
513478|NCT00724984|P4|Participant Flow|Cohort 4(60mg/m2,7days/wk)/Phase 1|
513479|NCT00724984|P3|Participant Flow|Cohort 3(45mg/m2,7days/wk)/Phase 1|
513480|NCT00724984|P2|Participant Flow|Cohort 2(45mg/m2,5days/wk)/Phase 1|
513481|NCT00724984|P1|Participant Flow|Cohort 1(30mg/m2,5days/wk)/Phase 1|
513482|NCT00724984|O2|Outcome|Mantle Cell Lymphoma/Phase II (Efficacy)|
513483|NCT00724984|O1|Outcome|Follicular/Phase II (Efficacy)|
513484|NCT00724984|O4|Outcome|Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I|
513485|NCT00724984|O3|Outcome|Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I|
513486|NCT00724984|O2|Outcome|Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I|
513487|NCT00724984|O1|Outcome|Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I|
513488|NCT00724984|E6|Reported Event|Mantle Cell Lymphoma/Phase II|
513489|NCT00724984|E5|Reported Event|Follicular/Phase II|
513490|NCT00724984|E4|Reported Event|Cohort 4(60 mg/m2,7days/wk)/Phase I|
513491|NCT00724984|E3|Reported Event|Cohort 3(45 mg/m2, 7days/wk)/Phase I|
513492|NCT00724984|E2|Reported Event|Cohort 2(45 mg/m2, 5days/wk)/Phase I|
513493|NCT00724984|E1|Reported Event|Cohort 1(30 mg/m2, 5days/wk)/Phase I|
513494|NCT00724958|B1|Baseline|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.
513495|NCT00724958|P1|Participant Flow|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513496|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513497|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513498|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513499|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513500|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513501|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513502|NCT00724958|E1|Reported Event|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
513503|NCT00724945|B1|Baseline|Overall|The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials.
513504|NCT00724945|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
513505|NCT00724945|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
513506|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
513507|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
513508|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
513509|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
513510|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
513511|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
513512|NCT00724945|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
513513|NCT00724945|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
513514|NCT00724932|B3|Baseline|Total|Total of all reporting groups
513515|NCT00724932|B2|Baseline|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513519|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513520|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513521|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513522|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513523|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513524|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513525|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513526|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513527|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513528|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513529|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513530|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513531|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513532|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513533|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513534|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513535|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513536|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513537|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513538|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513539|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513540|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513541|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513542|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513543|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513544|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513545|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513546|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513547|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513548|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513549|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513550|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513551|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513552|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513553|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513554|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513555|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513556|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513557|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513558|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513559|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513560|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513561|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513562|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513563|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513564|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513565|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513566|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513567|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
514413|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
513568|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513569|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513570|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513571|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513572|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513573|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513574|NCT00724932|O1|Outcome|Neostigmine Only|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513575|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513576|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513577|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513578|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513579|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513580|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513581|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513582|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
513583|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513584|NCT00724932|E2|Reported Event|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2
513585|NCT00724932|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
513586|NCT00724893|B3|Baseline|Total|Total of all reporting groups
513587|NCT00724893|B2|Baseline|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513588|NCT00724893|B1|Baseline|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513589|NCT00724893|P2|Participant Flow|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513590|NCT00724893|P1|Participant Flow|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513591|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513592|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513593|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513594|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513595|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513596|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513597|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513598|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513599|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513600|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513601|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513602|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513949|NCT00723944|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
513603|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513604|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513605|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513606|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513607|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513608|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513609|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513610|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513611|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513612|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513613|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513614|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513615|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513616|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513617|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513618|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513619|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513620|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513621|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513622|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513623|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513624|NCT00724893|O5|Outcome|>85 kg|Participants with weight >85 kg
513625|NCT00724893|O4|Outcome|75 to <85 kg|Participants with weight 75 to <85 kg
513626|NCT00724893|O3|Outcome|64 to <75 kg|Participants with weight 64 to <75 kg
513627|NCT00724893|O2|Outcome|50 to <64 kg|Participants with weight 50 to <64 kg
513628|NCT00724893|O1|Outcome|40 to <50 kg|Participants with weight 40 to <50 kg
513629|NCT00724893|O3|Outcome|Viral Load Missing|Participants with viral load missing
513630|NCT00724893|O2|Outcome|Viral Load Low|Participants with viral load xxxx
513631|NCT00724893|O1|Outcome|Viral Load High|Participants with viral load xxxx
513632|NCT00724893|O6|Outcome|Unknown Stage|Participants with unknown Fibrosis Stage
513633|NCT00724893|O5|Outcome|Stage F4|Participants with Fibrosis Stage F4
513634|NCT00724893|O4|Outcome|Stage F3|Participants with Fibrosis Stage F4
513635|NCT00724893|O3|Outcome|Stage F2|Participants with Fibrosis Stage F2
513636|NCT00724893|O2|Outcome|Stage F1|Participants with Fibrosis Stage F1
513637|NCT00724893|O1|Outcome|Stage F0|Participants with Fibrosis Stage F0
513638|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513639|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513640|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513641|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513642|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513643|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513644|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513645|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513646|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513647|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513648|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513649|NCT00724893|O2|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513650|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513651|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513652|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513653|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513654|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513655|NCT00724893|E2|Reported Event|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513656|NCT00724893|E1|Reported Event|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
513657|NCT00724867|B1|Baseline|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513658|NCT00724867|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513659|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513660|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513661|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513662|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513663|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513664|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513665|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513666|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513667|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513668|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513669|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513670|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513671|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513672|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513673|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513674|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513675|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513676|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513677|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513678|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513679|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513680|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513681|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513682|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513683|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513684|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513685|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513686|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513687|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513688|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513689|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513690|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513691|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513692|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
513693|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
513694|NCT00724867|E1|Reported Event|Belimumab 10 mg/kg IV|Belimumab 10 mg/kg IV every 28 days
513695|NCT00724854|B3|Baseline|Total|Total of all reporting groups
513696|NCT00724854|B2|Baseline|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513697|NCT00724854|B1|Baseline|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513698|NCT00724854|P2|Participant Flow|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513699|NCT00724854|P1|Participant Flow|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513700|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513701|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513702|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513703|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513704|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513705|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513706|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513707|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513708|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513709|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513710|NCT00724854|E3|Reported Event|Not Evaluated|
513711|NCT00724854|E2|Reported Event|Co-Infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513712|NCT00724854|E1|Reported Event|Mono-Infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
513713|NCT00724815|B3|Baseline|Total|Total of all reporting groups
513714|NCT00724815|B2|Baseline|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513715|NCT00724815|B1|Baseline|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513716|NCT00724815|P2|Participant Flow|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513717|NCT00724815|P1|Participant Flow|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513718|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513719|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513720|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513721|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513722|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513723|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513724|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513725|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513726|NCT00724815|E2|Reported Event|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513727|NCT00724815|E1|Reported Event|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
513728|NCT00724750|B3|Baseline|Total|Total of all reporting groups
513729|NCT00724750|B2|Baseline|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513730|NCT00724750|B1|Baseline|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513731|NCT00724750|P2|Participant Flow|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513732|NCT00724750|P1|Participant Flow|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513733|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513734|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513735|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513736|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513737|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513738|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513739|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513740|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513741|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513742|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513743|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513744|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513745|NCT00724750|E2|Reported Event|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
513746|NCT00724750|E1|Reported Event|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
513747|NCT00724711|B3|Baseline|Total|Total of all reporting groups
513748|NCT00724711|B2|Baseline|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513749|NCT00724711|B1|Baseline|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513750|NCT00724711|P2|Participant Flow|Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI)|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513751|NCT00724711|P1|Participant Flow|FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen)|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513752|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513753|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513754|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513755|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513756|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513757|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513758|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513759|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513760|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513761|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513762|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513763|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513764|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513765|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513766|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513767|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513768|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513950|NCT00723944|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
513769|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513770|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513771|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513772|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513773|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513774|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513775|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513776|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513777|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513778|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513779|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513780|NCT00724711|E2|Reported Event|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
513781|NCT00724711|E1|Reported Event|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
513782|NCT00724698|B1|Baseline|Desloratadine|Desloratadine 5 mg daily
513783|NCT00724698|P1|Participant Flow|Desloratadine|Desloratadine 5 mg daily
513784|NCT00724698|O1|Outcome|Desloratadine|Desloratadine 5 mg daily
513785|NCT00724594|B5|Baseline|Total|Total of all reporting groups
513786|NCT00724594|B4|Baseline|Control Maternal|Mothers of infants treated with saline
513787|NCT00724594|B3|Baseline|NAC Maternal|Mothers of infants treated with N-acetylcysteine
513788|NCT00724594|B2|Baseline|Control Infant|Infants treated with saline
513789|NCT00724594|B1|Baseline|NAC Infant|Infants treated with N-acetylcysteine
513790|NCT00724594|P4|Participant Flow|Control Maternal|Mothers of infants treated with saline
513791|NCT00724594|P3|Participant Flow|NAC Maternal|Mothers of infants treated with N-acetylcysteine
513792|NCT00724594|P2|Participant Flow|Control Infant|Infants treated with saline
513793|NCT00724594|P1|Participant Flow|NAC Infant|Infants treated with N-acetylcysteine
513794|NCT00724594|O4|Outcome|Control Maternal|Mothers treated with saline prior to delivery
513795|NCT00724594|O3|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
513796|NCT00724594|O2|Outcome|Control Infants|Infants treated with saline
513797|NCT00724594|O1|Outcome|NAC Infants|Infants treated with N-acetylcysteine
513798|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to birth
513799|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
513800|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
513801|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
513802|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
513803|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
513804|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
513805|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
513806|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
513807|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
513808|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
513809|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
513810|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
513811|NCT00724594|E4|Reported Event|Control Maternal|Mothers of infants treated with saline
513812|NCT00724594|E3|Reported Event|NAC Maternal|Mothers of infants treated with N-acetylcysteine
513813|NCT00724594|E2|Reported Event|Control Infant|Infants treated with saline
513814|NCT00724594|E1|Reported Event|NAC Infant|Infants treated with N-acetylcysteine
513815|NCT00724568|B1|Baseline|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
514414|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
513816|NCT00724568|P2|Participant Flow|Phase II|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
513817|NCT00724568|P1|Participant Flow|Phase I|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
513818|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
513819|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
513820|NCT00724568|E1|Reported Event|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
513821|NCT00724477|B1|Baseline|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
513822|NCT00724477|P1|Participant Flow|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
513823|NCT00724477|O1|Outcome|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
513824|NCT00724477|E1|Reported Event|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
513825|NCT00724464|B1|Baseline|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513826|NCT00724464|P1|Participant Flow|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513827|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
513828|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513829|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513830|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513831|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513857|NCT00724308|O1|Outcome|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
526205|NCT00699608|E2|Reported Event|Eszopiclone|3 mg Eszopiclone
513832|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513833|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513834|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513835|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
513836|NCT00724464|E1|Reported Event|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
513837|NCT00724451|B1|Baseline|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
513838|NCT00724451|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
513839|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
513840|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
513841|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
513842|NCT00724451|E1|Reported Event|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
513843|NCT00724373|B1|Baseline|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
513844|NCT00724373|P1|Participant Flow|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
513845|NCT00724373|O1|Outcome|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
513846|NCT00724373|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
513847|NCT00724347|B1|Baseline|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
513848|NCT00724347|P1|Participant Flow|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
513849|NCT00724347|O1|Outcome|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
513850|NCT00724347|E1|Reported Event|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
513851|NCT00724308|B3|Baseline|Total|Total of all reporting groups
513852|NCT00724308|B2|Baseline|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
513853|NCT00724308|B1|Baseline|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
513854|NCT00724308|P2|Participant Flow|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
513855|NCT00724308|P1|Participant Flow|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
513856|NCT00724308|O2|Outcome|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
513858|NCT00724308|E2|Reported Event|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
513859|NCT00724308|E1|Reported Event|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
513860|NCT00724282|B1|Baseline|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
513861|NCT00724282|P1|Participant Flow|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
513862|NCT00724282|O1|Outcome|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
513863|NCT00724282|E1|Reported Event|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
513864|NCT00724243|B1|Baseline|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
513865|NCT00724243|P1|Participant Flow|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
513866|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
513867|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
513868|NCT00724243|E1|Reported Event|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
513869|NCT00724152|B6|Baseline|Total|Total of all reporting groups
513870|NCT00724152|B5|Baseline|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
513871|NCT00724152|B4|Baseline|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
513872|NCT00724152|B3|Baseline|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp randomize.
513873|NCT00724152|B2|Baseline|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
513874|NCT00724152|B1|Baseline|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp randomize.
513875|NCT00724152|P3|Participant Flow|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
513876|NCT00724152|P2|Participant Flow|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources."
513948|NCT00723944|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
513877|NCT00724152|P1|Participant Flow|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
513878|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
513879|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
513880|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
513881|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
513882|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
513883|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
513884|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
513885|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
513886|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
513887|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
513888|NCT00724152|E3|Reported Event|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
513889|NCT00724152|E2|Reported Event|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment."
513890|NCT00724152|E1|Reported Event|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
513891|NCT00724126|B3|Baseline|Total|Total of all reporting groups
513892|NCT00724126|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513893|NCT00724126|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513894|NCT00724126|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513895|NCT00724126|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513896|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513897|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513898|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513899|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513900|NCT00724126|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513901|NCT00724126|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
513902|NCT00724061|B1|Baseline|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
513903|NCT00724061|P1|Participant Flow|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
513904|NCT00724061|O1|Outcome|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
513905|NCT00724061|E1|Reported Event|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
513906|NCT00724009|B1|Baseline|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513907|NCT00724009|P1|Participant Flow|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513908|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513909|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513910|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513911|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513912|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513913|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513914|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513915|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513916|NCT00724009|E1|Reported Event|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
513917|NCT00723957|B3|Baseline|Total|Total of all reporting groups
513918|NCT00723957|B2|Baseline|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513919|NCT00723957|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513920|NCT00723957|P2|Participant Flow|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513921|NCT00723957|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513922|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513923|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
515271|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
513924|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513925|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513926|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513927|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513928|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513929|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513930|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513931|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513932|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513933|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513934|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513935|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513936|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513937|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513938|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513939|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513940|NCT00723957|E2|Reported Event|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
513941|NCT00723957|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
513942|NCT00723944|B3|Baseline|Total|Total of all reporting groups
513943|NCT00723944|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
513944|NCT00723944|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
513945|NCT00723944|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
513946|NCT00723944|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
513947|NCT00723944|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
513951|NCT00723931|B1|Baseline|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
513952|NCT00723931|P1|Participant Flow|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
513953|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
513954|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
513955|NCT00723931|E1|Reported Event|Pegintron/Pegintron Redipen Injection|
513956|NCT00723892|B3|Baseline|Total|Total of all reporting groups
513957|NCT00723892|B2|Baseline|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513958|NCT00723892|B1|Baseline|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513959|NCT00723892|P2|Participant Flow|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513960|NCT00723892|P1|Participant Flow|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513961|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513962|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513963|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513964|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
513965|NCT00723892|E1|Reported Event|All Enrolled Participants|
513966|NCT00723840|B1|Baseline|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
513967|NCT00723840|P1|Participant Flow|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
513968|NCT00723840|O4|Outcome|18 Months|QoL scores per participant at 18 months
513969|NCT00723840|O3|Outcome|12 Months|QoL scores per participant at 12 months
513970|NCT00723840|O2|Outcome|6 Months|QoL scores per participant at 6 months
513971|NCT00723840|O1|Outcome|Baseline|QoL scores per participant at baseline
513972|NCT00723840|O4|Outcome|18 Months|Costs per participant at 18 months in Euros
513973|NCT00723840|O3|Outcome|12 Months|Costs per participant at 12 months in Euros
513974|NCT00723840|O2|Outcome|6 Months|Costs per participant at 6 months in Euros
513975|NCT00723840|O1|Outcome|Baseline|Costs per participant at baseline in Euros
513976|NCT00723840|E1|Reported Event|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
513977|NCT00723827|B1|Baseline|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
513978|NCT00723827|P1|Participant Flow|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
513979|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
513980|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
513981|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
514040|NCT00723606|P1|Participant Flow|Ziprasidone|An initial intramuscular (IM) injection of ziprasidone 10 or 20 milligram (mg). Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours possible treatment.
513982|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
513983|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
513984|NCT00723827|E1|Reported Event|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
513985|NCT00723801|B3|Baseline|Total|Total of all reporting groups
513986|NCT00723801|B2|Baseline|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
513987|NCT00723801|B1|Baseline|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
513988|NCT00723801|P2|Participant Flow|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
513989|NCT00723801|P1|Participant Flow|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
513990|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
513991|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
513992|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
513993|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
513994|NCT00723801|E2|Reported Event|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
513995|NCT00723801|E1|Reported Event|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
513996|NCT00723788|B1|Baseline|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
513997|NCT00723788|P1|Participant Flow|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
513998|NCT00723788|O3|Outcome|CT of the Abdomen|All patients enrolled received an MRI followed in some cases by computed tomography.
513999|NCT00723788|O2|Outcome|US of the Abdomen|All patients enrolled received an MRI followed in some cases by ultrasund.
514000|NCT00723788|O1|Outcome|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
514001|NCT00723788|E1|Reported Event|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
514002|NCT00723749|B1|Baseline|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
514003|NCT00723749|P1|Participant Flow|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
514004|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
514005|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
514006|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
514007|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
514008|NCT00723749|E1|Reported Event|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
514009|NCT00723736|B1|Baseline|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
514010|NCT00723736|P1|Participant Flow|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
514011|NCT00723736|O1|Outcome|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
514012|NCT00723736|E1|Reported Event|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
514013|NCT00723710|B1|Baseline|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
514014|NCT00723710|P1|Participant Flow|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
514041|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514015|NCT00723710|O1|Outcome|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
514016|NCT00723710|E1|Reported Event|Intron-A|
514017|NCT00723697|B1|Baseline|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
514018|NCT00723697|P1|Participant Flow|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
514019|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
514020|NCT00723697|O3|Outcome|Patients at 12 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
514021|NCT00723697|O2|Outcome|Patients at 6 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
514022|NCT00723697|O1|Outcome|Patients at First Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
514023|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
514024|NCT00723697|E1|Reported Event|Patients|
514025|NCT00723645|B1|Baseline|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
514026|NCT00723645|P1|Participant Flow|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
514027|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
514028|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
514029|NCT00723645|E1|Reported Event|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
514030|NCT00723632|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
514031|NCT00723632|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
514032|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
514033|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
514034|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
514035|NCT00723632|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
514036|NCT00723606|B3|Baseline|Total|Total of all reporting groups
514037|NCT00723606|B2|Baseline|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514038|NCT00723606|B1|Baseline|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514039|NCT00723606|P2|Participant Flow|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514042|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514043|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514044|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514045|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514046|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514047|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514048|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514049|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514050|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514051|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514052|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514053|NCT00723606|E2|Reported Event|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
514054|NCT00723606|E1|Reported Event|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
514055|NCT00723580|B1|Baseline|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
514056|NCT00723580|P1|Participant Flow|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
514057|NCT00723580|O1|Outcome|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
514092|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514093|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514094|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514095|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514058|NCT00723580|E1|Reported Event|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
514059|NCT00723554|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514060|NCT00723554|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514061|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514062|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514063|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514064|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514065|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514066|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514067|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514068|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514069|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514070|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514071|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514072|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514073|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514074|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514075|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514076|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514077|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514078|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514079|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514080|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514081|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514082|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514083|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514084|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514085|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514086|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514087|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514088|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514089|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514090|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514091|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
515272|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
514096|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514097|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514098|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
514099|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514100|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514101|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
514102|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514103|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514104|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514105|NCT00723554|E1|Reported Event|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
514106|NCT00723528|B4|Baseline|Total|Total of all reporting groups
514107|NCT00723528|B3|Baseline|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514108|NCT00723528|B2|Baseline|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514109|NCT00723528|B1|Baseline|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
514110|NCT00723528|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
514111|NCT00723528|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
514112|NCT00723528|P5|Participant Flow|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514113|NCT00723528|P4|Participant Flow|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514114|NCT00723528|P3|Participant Flow|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514115|NCT00723528|P2|Participant Flow|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514116|NCT00723528|P1|Participant Flow|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
514117|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514118|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514119|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514120|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514121|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514122|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514123|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
514124|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514125|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
515273|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
514126|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514127|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514128|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514129|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514130|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514131|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514132|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514133|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514134|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514135|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514136|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514137|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514138|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514139|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514140|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514141|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514142|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514143|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514144|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514145|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514146|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514172|NCT00723528|E1|Reported Event|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
514173|NCT00723489|B5|Baseline|Total|Total of all reporting groups
514147|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514148|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514149|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514150|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514151|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514152|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514153|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514154|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514155|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514156|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514157|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514158|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514159|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514160|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514161|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514162|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
514163|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514164|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514165|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
514166|NCT00723528|E7|Reported Event|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
514167|NCT00723528|E6|Reported Event|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
514168|NCT00723528|E5|Reported Event|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
514169|NCT00723528|E4|Reported Event|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
514170|NCT00723528|E3|Reported Event|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514171|NCT00723528|E2|Reported Event|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
514174|NCT00723489|B4|Baseline|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514175|NCT00723489|B3|Baseline|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514176|NCT00723489|B2|Baseline|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514177|NCT00723489|B1|Baseline|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514178|NCT00723489|P4|Participant Flow|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514179|NCT00723489|P3|Participant Flow|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514180|NCT00723489|P2|Participant Flow|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514181|NCT00723489|P1|Participant Flow|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514182|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514183|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514184|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514185|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514186|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514187|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514188|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514189|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514190|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514191|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514192|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514213|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514193|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514194|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514195|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514196|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514197|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514198|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514199|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514200|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514201|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514202|NCT00723489|E4|Reported Event|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514203|NCT00723489|E3|Reported Event|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
514204|NCT00723489|E2|Reported Event|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
514205|NCT00723489|E1|Reported Event|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
514206|NCT00723450|B3|Baseline|Total|Total of all reporting groups
514207|NCT00723450|B2|Baseline|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514208|NCT00723450|B1|Baseline|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514209|NCT00723450|P3|Participant Flow|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514210|NCT00723450|P2|Participant Flow|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514211|NCT00723450|P1|Participant Flow|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514212|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514278|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
514214|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514215|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514216|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514217|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514218|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514219|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514220|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514221|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514222|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514223|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514224|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514225|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514226|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514227|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514228|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514229|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514230|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
515274|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
514231|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514232|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514233|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514234|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514235|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
514236|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514237|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514238|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514239|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514240|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514241|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514242|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514243|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514244|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514245|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514246|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514247|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
514248|NCT00723450|E3|Reported Event|Randomized and Double-blind Taper Phases: LTG|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Randomized Phase.
514249|NCT00723450|E2|Reported Event|Randomized and Double-blind Taper Phases: Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks. The participant received Placebo during this Phase.
514279|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
514280|NCT00723255|E1|Reported Event|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
514250|NCT00723450|E1|Reported Event|Open-Label and Open-Label Taper Phases: LTG|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants discontinuing from the study during the Open-Label Phase entered an open Taper and Follow-up Phase.The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Open-Label Phase.
514251|NCT00723294|B1|Baseline|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
514252|NCT00723294|P1|Participant Flow|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
514253|NCT00723294|O1|Outcome|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
514254|NCT00723294|O1|Outcome|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
514255|NCT00723294|E1|Reported Event|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
514256|NCT00723255|B1|Baseline|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
514257|NCT00723255|P1|Participant Flow|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
514258|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
514259|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
514260|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
514261|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
514262|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
514263|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
514264|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
514265|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
514266|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
514267|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
514268|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
514269|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
514270|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
514271|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
514272|NCT00723255|O6|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
514273|NCT00723255|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
514274|NCT00723255|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
514275|NCT00723255|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
514276|NCT00723255|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
514277|NCT00723255|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
514284|NCT00723229|P2|Participant Flow|Acyclovir 400 mg Twice Daily First, Followed by no Medication|Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks
514285|NCT00723229|P1|Participant Flow|No Medication First, Then Standard-dose Acyclovir|No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks
514286|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
514287|NCT00723229|O1|Outcome|No Medication|
514288|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
514289|NCT00723229|O1|Outcome|No Medication|
514290|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
514291|NCT00723229|O1|Outcome|No Medication|
514292|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
514293|NCT00723229|O1|Outcome|No Medication|
514294|NCT00723229|E2|Reported Event|Acyclovir 400 mg Twice Daily|
514295|NCT00723229|E1|Reported Event|No Medication|
514296|NCT00723203|B1|Baseline|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
514297|NCT00723203|P1|Participant Flow|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
514298|NCT00723203|O1|Outcome|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
514299|NCT00723203|E1|Reported Event|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
514300|NCT00723190|B1|Baseline|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514301|NCT00723190|P1|Participant Flow|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514302|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514303|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514304|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514305|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514306|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514307|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514308|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514309|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514310|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514311|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514312|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514313|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514314|NCT00723190|E1|Reported Event|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
514315|NCT00723177|B4|Baseline|Total|Total of all reporting groups
515275|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
514316|NCT00723177|B3|Baseline|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514317|NCT00723177|B2|Baseline|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514318|NCT00723177|B1|Baseline|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514319|NCT00723177|P3|Participant Flow|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
514320|NCT00723177|P2|Participant Flow|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
514321|NCT00723177|P1|Participant Flow|Placebo|"This group received placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
514322|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514323|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514324|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514325|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514326|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514327|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514328|NCT00723177|E3|Reported Event|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514329|NCT00723177|E2|Reported Event|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514330|NCT00723177|E1|Reported Event|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
514331|NCT00723125|B3|Baseline|Total|Total of all reporting groups
514332|NCT00723125|B2|Baseline|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
514333|NCT00723125|B1|Baseline|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
514334|NCT00723125|P2|Participant Flow|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
514335|NCT00723125|P1|Participant Flow|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
514336|NCT00723125|O2|Outcome|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
514366|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514367|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
515276|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
514337|NCT00723125|O1|Outcome|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
514338|NCT00723125|E6|Reported Event|Cohort 2 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
514339|NCT00723125|E5|Reported Event|Cohort 1 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
514340|NCT00723125|E4|Reported Event|Cohort 2 DDAC|Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
514341|NCT00723125|E3|Reported Event|Cohort 1 DDAC|Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
514342|NCT00723125|E2|Reported Event|Cohort 2 Neo-adjuvant|Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)
514343|NCT00723125|E1|Reported Event|Cohort 1 Neo-adjuvant|Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10
514344|NCT00723073|B3|Baseline|Total|Total of all reporting groups
514345|NCT00723073|B2|Baseline|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514346|NCT00723073|B1|Baseline|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514347|NCT00723073|P2|Participant Flow|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514348|NCT00723073|P1|Participant Flow|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514349|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514350|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514351|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514352|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514353|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514354|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514355|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514356|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514357|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514358|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514359|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514360|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514361|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514362|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514363|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514364|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514365|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514415|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514368|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514369|NCT00723073|E2|Reported Event|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
514370|NCT00723073|E1|Reported Event|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
514371|NCT00723021|B1|Baseline|All Participants|Participants receiving any of the 5 treatments (PF-04191834 30 mg, PF-04191834 100 mg, PF-04191834 2000 mg, Zileuton CR 1200 mg and Placebo) in a randomized fashion first
514372|NCT00723021|P5|Participant Flow|Treatment Sequence 5|Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg
514373|NCT00723021|P4|Participant Flow|Treatment Sequence 4|PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg
514374|NCT00723021|P3|Participant Flow|Treatment Sequence 3|PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo
514375|NCT00723021|P2|Participant Flow|Treatment Sequence 2|PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg
514376|NCT00723021|P1|Participant Flow|Treatment Sequence 1|Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg
514377|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514378|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514379|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514380|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514381|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514382|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514383|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514384|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514385|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514386|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514387|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514388|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514389|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514390|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514391|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514392|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
514393|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514394|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514395|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514396|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
514397|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
514398|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514399|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
514400|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
514401|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
514402|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
514403|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514404|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514405|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514406|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
514407|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
514408|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514409|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
514410|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
514411|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
514416|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
514417|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
514418|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514419|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514420|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514421|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
514422|NCT00723021|E5|Reported Event|Zileuton CR 1200 mg|Paticipants received single oral dose of zileuton CR1200 mg (2 x 600 mg tablets) in any treatment period
514423|NCT00723021|E4|Reported Event|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
514424|NCT00723021|E3|Reported Event|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
514425|NCT00723021|E2|Reported Event|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
514426|NCT00723021|E1|Reported Event|Placebo|Participants received single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
514427|NCT00723008|B3|Baseline|Total|Total of all reporting groups
514428|NCT00723008|B2|Baseline|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514429|NCT00723008|B1|Baseline|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514430|NCT00723008|P2|Participant Flow|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514431|NCT00723008|P1|Participant Flow|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514432|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514433|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514434|NCT00723008|O4|Outcome|Group B: AFTER Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
514435|NCT00723008|O3|Outcome|Group B: BEFORE Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
514436|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
514437|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
514438|NCT00723008|O4|Outcome|Group B: AFTER Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
514439|NCT00723008|O3|Outcome|Group B: BEFORE Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
514440|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
514441|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
514464|NCT00722800|P1|Participant Flow|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
514442|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514443|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514444|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514445|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514446|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514447|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
514448|NCT00723008|E4|Reported Event|Group B: Unblinded Phase|Subjects Previously receiving sham device, now using active Alpha Stim device with settings at the patient's preference (1 to 6/6), one hour per day for 5 days per week for 4 weeks.
514449|NCT00723008|E3|Reported Event|Group B: Blinded Phase|Subjects receiving sham CES treatment for 1 hour daily for 4 weeks.
514450|NCT00723008|E2|Reported Event|Group A: Unblinded Phase|Subjects using Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6).
514451|NCT00723008|E1|Reported Event|Group A: Blinded Phase|Subjects receiving double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) for one hour daily.
514452|NCT00722865|B1|Baseline|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514453|NCT00722865|P1|Participant Flow|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514454|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514455|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514456|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514457|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514458|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514459|NCT00722865|E1|Reported Event|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
514460|NCT00722800|B3|Baseline|Total|Total of all reporting groups
514461|NCT00722800|B2|Baseline|Placebo Tablets|Placebo tablet once a day for 6 months
514462|NCT00722800|B1|Baseline|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
514463|NCT00722800|P2|Participant Flow|Placebo Tablets|Placebo tablet once a day for 6 months
514465|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
514470|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
514471|NCT00722800|E2|Reported Event|Placebo Tablets|Placebo tablet once a day for 6 months
514472|NCT00722800|E1|Reported Event|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
514473|NCT00722761|B3|Baseline|Total|Total of all reporting groups
514474|NCT00722761|B2|Baseline|Placebo Tablet|Placebo tablet once a day
514475|NCT00722761|B1|Baseline|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
514476|NCT00722761|P2|Participant Flow|Placebo Tablet|Placebo tablet once a day
514477|NCT00722761|P1|Participant Flow|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
514478|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
514479|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
514480|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
514481|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
514482|NCT00722761|E2|Reported Event|Placebo Tablet|Placebo tablet once a day
514483|NCT00722761|E1|Reported Event|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
514484|NCT00722722|B4|Baseline|Total|Total of all reporting groups
514485|NCT00722722|B3|Baseline|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514486|NCT00722722|B2|Baseline|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514487|NCT00722722|B1|Baseline|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514488|NCT00722722|P3|Participant Flow|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514489|NCT00722722|P2|Participant Flow|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514490|NCT00722722|P1|Participant Flow|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514491|NCT00722722|O3|Outcome|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514492|NCT00722722|O2|Outcome|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514493|NCT00722722|O1|Outcome|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514494|NCT00722722|E3|Reported Event|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514495|NCT00722722|E2|Reported Event|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514496|NCT00722722|E1|Reported Event|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
514497|NCT00722566|B3|Baseline|Total|Total of all reporting groups
514498|NCT00722566|B2|Baseline|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514499|NCT00722566|B1|Baseline|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514500|NCT00722566|P2|Participant Flow|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514501|NCT00722566|P1|Participant Flow|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514502|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514503|NCT00722566|O1|Outcome|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514504|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514505|NCT00722566|O1|Outcome|VELCADE Subcutaneuous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514506|NCT00722566|E2|Reported Event|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514507|NCT00722566|E1|Reported Event|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
514508|NCT00722553|B1|Baseline|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
514509|NCT00722553|P1|Participant Flow|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
514510|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
514511|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
514512|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
514513|NCT00722553|O1|Outcome|Evaluable Patients|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
514514|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
514515|NCT00722553|E1|Reported Event|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
514516|NCT00722436|B3|Baseline|Total|Total of all reporting groups
514517|NCT00722436|B2|Baseline|Placebo|"Saline~saline: Placebo"
514518|NCT00722436|B1|Baseline|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
514519|NCT00722436|P2|Participant Flow|Placebo|"Saline~saline: Placebo"
514520|NCT00722436|P1|Participant Flow|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
514521|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
514522|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
514523|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
514524|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
514525|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
514526|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
514527|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
514528|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
514529|NCT00722436|E2|Reported Event|Placebo|"Saline~saline: Placebo"
514530|NCT00722436|E1|Reported Event|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
514531|NCT00722423|B3|Baseline|Total|Total of all reporting groups
514532|NCT00722423|B2|Baseline|Usucal Care Model|
514533|NCT00722423|B1|Baseline|Integrated Care Model|Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.
514534|NCT00722423|P2|Participant Flow|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
514535|NCT00722423|P1|Participant Flow|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
514536|NCT00722423|O2|Outcome|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
514537|NCT00722423|O1|Outcome|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
514538|NCT00722423|O2|Outcome|Usual Care Model|"usual care~Patients receive care as usual in their HCV clinic. This care does not include the co-located mental health provider."
514581|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514582|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514583|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514539|NCT00722423|O1|Outcome|Integrated Care Model|"integrated care~Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals."
514540|NCT00722423|E2|Reported Event|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
514541|NCT00722423|E1|Reported Event|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
514542|NCT00722371|B8|Baseline|Total|Total of all reporting groups
514543|NCT00722371|B7|Baseline|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514544|NCT00722371|B6|Baseline|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514545|NCT00722371|B5|Baseline|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514546|NCT00722371|B4|Baseline|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514547|NCT00722371|B3|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514548|NCT00722371|B2|Baseline|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514549|NCT00722371|B1|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514550|NCT00722371|P7|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514551|NCT00722371|P6|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514552|NCT00722371|P5|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514553|NCT00722371|P4|Participant Flow|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514554|NCT00722371|P3|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514555|NCT00722371|P2|Participant Flow|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514556|NCT00722371|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514557|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514558|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514559|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514560|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514561|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514562|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514563|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514564|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514565|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514566|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514567|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514568|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514569|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514570|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514571|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514572|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514573|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514574|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514575|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514576|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514577|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514578|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514579|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514580|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
515277|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
514584|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514585|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514586|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514587|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514588|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514589|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514590|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514591|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514592|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514593|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514594|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514595|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514596|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514597|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514598|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514599|NCT00722371|E7|Reported Event|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
514600|NCT00722371|E6|Reported Event|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
514601|NCT00722371|E5|Reported Event|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
514602|NCT00722371|E4|Reported Event|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
514603|NCT00722371|E3|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
514604|NCT00722371|E2|Reported Event|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
514605|NCT00722371|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
514606|NCT00722137|B3|Baseline|Total|Total of all reporting groups
514607|NCT00722137|B2|Baseline|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514608|NCT00722137|B1|Baseline|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514609|NCT00722137|P2|Participant Flow|R-CHOP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles"
514610|NCT00722137|P1|Participant Flow|VcR-CAP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514611|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514612|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514613|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514689|NCT00721955|B1|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
514690|NCT00721955|P3|Participant Flow|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
514614|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514615|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514616|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514617|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514618|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514619|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514620|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514621|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514622|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514623|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514624|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514625|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514626|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514627|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514628|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514691|NCT00721955|P2|Participant Flow|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
515278|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
514629|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514630|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514631|NCT00722137|E2|Reported Event|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
514632|NCT00722137|E1|Reported Event|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
514633|NCT00722124|B4|Baseline|Total|Total of all reporting groups
514634|NCT00722124|B3|Baseline|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
514635|NCT00722124|B2|Baseline|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
514636|NCT00722124|B1|Baseline|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
514637|NCT00722124|P3|Participant Flow|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
514638|NCT00722124|P2|Participant Flow|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
514639|NCT00722124|P1|Participant Flow|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
514640|NCT00722124|O3|Outcome|Placebo|
514641|NCT00722124|O2|Outcome|SAMe 1600|
514642|NCT00722124|O1|Outcome|SAMe 800|
514643|NCT00722124|E3|Reported Event|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
514644|NCT00722124|E2|Reported Event|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
514645|NCT00722124|E1|Reported Event|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
514646|NCT00722111|B3|Baseline|Total|Total of all reporting groups
514647|NCT00722111|B2|Baseline|Lingual Pressure Norms|Normative values for lingual pressures
514648|NCT00722111|B1|Baseline|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
514649|NCT00722111|P2|Participant Flow|Lingual Pressure Norms|Normative values for lingual pressures
514650|NCT00722111|P1|Participant Flow|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
514651|NCT00722111|O2|Outcome|Lingual Pressure Norms|Normative values for lingual pressures
514652|NCT00722111|O1|Outcome|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
514653|NCT00722111|O1|Outcome|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
514654|NCT00722111|E2|Reported Event|Lingual Pressure Norms|Normative values for lingual pressures
514655|NCT00722111|E1|Reported Event|Lingual Strengthening|Isometric Progressive resistance oropharyngeal strengthening for 8 weeks.
514656|NCT00722072|B1|Baseline|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
514657|NCT00722072|P1|Participant Flow|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
514658|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
514659|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
515279|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
526206|NCT00699608|E1|Reported Event|Placebo|Placebo
514660|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
514661|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
514662|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
514663|NCT00722072|E1|Reported Event|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
514664|NCT00722020|B3|Baseline|Total|Total of all reporting groups
514665|NCT00722020|B2|Baseline|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
514666|NCT00722020|B1|Baseline|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
514667|NCT00722020|P2|Participant Flow|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
514668|NCT00722020|P1|Participant Flow|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
514669|NCT00722020|O2|Outcome|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
514670|NCT00722020|O1|Outcome|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
514671|NCT00722020|O2|Outcome|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
514672|NCT00722020|O1|Outcome|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
514673|NCT00722020|E2|Reported Event|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
514674|NCT00722020|E1|Reported Event|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
514675|NCT00721968|B3|Baseline|Total|Total of all reporting groups
514676|NCT00721968|B2|Baseline|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
514677|NCT00721968|B1|Baseline|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
514678|NCT00721968|P2|Participant Flow|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
514679|NCT00721968|P1|Participant Flow|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
514680|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
514681|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
514682|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
514683|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
514684|NCT00721968|E2|Reported Event|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
514685|NCT00721968|E1|Reported Event|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
514686|NCT00721955|B4|Baseline|Total|Total of all reporting groups
514687|NCT00721955|B3|Baseline|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
514688|NCT00721955|B2|Baseline|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
514692|NCT00721955|P1|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
514693|NCT00721955|O3|Outcome|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
514694|NCT00721955|O2|Outcome|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
514695|NCT00721955|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
514696|NCT00721955|O3|Outcome|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
514697|NCT00721955|O2|Outcome|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
514698|NCT00721955|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
514699|NCT00721955|O3|Outcome|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
514700|NCT00721955|O2|Outcome|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
514701|NCT00721955|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
514702|NCT00721955|E3|Reported Event|Inhaled Loxapine 10 mg|"Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2~Inhaled loxapine 10 mg: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2"
514703|NCT00721955|E2|Reported Event|Inhaled Loxapine 5 mg|"Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2~Inhaled loxapine 5 mg: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2"
514704|NCT00721955|E1|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo, may repeat after 2 hours x 2~Inhaled Placebo: Inhaled loxapine Placebo, may repeat after 2 hours x 2"
514705|NCT00721799|B1|Baseline|FLT PET|"Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.~F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]"
514706|NCT00721799|P1|Participant Flow|FLT PET|"Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.~F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]"
514707|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514708|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514709|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514710|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514711|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514712|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514713|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514714|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514715|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514716|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514717|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514880|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514718|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514719|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514720|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514721|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514722|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514723|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514724|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514725|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514726|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514727|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514728|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514729|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514730|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514731|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514732|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514733|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514734|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514735|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514736|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514737|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514738|NCT00721799|O1|Outcome|FLT PET Scan|"Subjects receive 2 18F-Fluorothymidine PET scans~Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)~Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)~F-18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%).~Imaging technology: PET scan"
514739|NCT00721799|E1|Reported Event|FLT PET|"Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.~F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]"
514740|NCT00721734|B6|Baseline|Total|Total of all reporting groups
514741|NCT00721734|B5|Baseline|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514742|NCT00721734|B4|Baseline|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514743|NCT00721734|B3|Baseline|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514744|NCT00721734|B2|Baseline|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514745|NCT00721734|B1|Baseline|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514746|NCT00721734|P5|Participant Flow|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514747|NCT00721734|P4|Participant Flow|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514748|NCT00721734|P3|Participant Flow|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514749|NCT00721734|P2|Participant Flow|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514750|NCT00721734|P1|Participant Flow|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514751|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514752|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514753|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514754|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514755|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514756|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514757|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514758|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514759|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514760|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514761|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514762|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514763|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514764|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514765|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514766|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514767|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514768|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514769|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514980|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514770|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514771|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514772|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514773|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514774|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514775|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514776|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514777|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514778|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514779|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514780|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514781|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514782|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514783|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514784|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
515064|NCT00721396|P4|Participant Flow|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
526207|NCT00699582|B4|Baseline|Total|Total of all reporting groups
514785|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514786|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514787|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514788|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514789|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514790|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514791|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514792|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514793|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514794|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514795|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514796|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514797|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514798|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514799|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
515065|NCT00721396|P3|Participant Flow|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
514800|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514801|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514802|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514803|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514804|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514805|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514806|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514807|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514808|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514809|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514810|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514811|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514812|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514813|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514814|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
515066|NCT00721396|P2|Participant Flow|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
514815|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514816|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514817|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514818|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514819|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514820|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514821|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514822|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514823|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514824|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514825|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514826|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514827|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514828|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514829|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
515067|NCT00721396|P1|Participant Flow|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
514830|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514831|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514832|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514833|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514834|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514835|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514836|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514837|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514838|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514839|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514840|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514841|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514842|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514843|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514844|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
515068|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
526685|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|
514845|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514846|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514847|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514848|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514849|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514850|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514851|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514852|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514853|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514854|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514855|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514856|NCT00721734|E5|Reported Event|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514857|NCT00721734|E4|Reported Event|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514858|NCT00721734|E3|Reported Event|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514859|NCT00721734|E2|Reported Event|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
515069|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
514860|NCT00721734|E1|Reported Event|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
514861|NCT00721630|B1|Baseline|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
514862|NCT00721630|P1|Participant Flow|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
514863|NCT00721630|O1|Outcome|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
514864|NCT00721630|O1|Outcome|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
514865|NCT00721630|E1|Reported Event|Capecitabine + Lapatinib|"The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.~capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week)."
514866|NCT00721617|B1|Baseline|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h.
514867|NCT00721617|P1|Participant Flow|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514868|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514869|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514870|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514871|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514872|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514873|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514874|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514875|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514876|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514877|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514878|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514879|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514881|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514882|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514883|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514884|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514885|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514886|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514887|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514888|NCT00721617|O1|Outcome|Healthy Subjects|Subjects received either IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) in a random order.
514889|NCT00721617|E1|Reported Event|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
514890|NCT00721578|B1|Baseline|Entire Study Population|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514891|NCT00721578|P2|Participant Flow|Other Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
514892|NCT00721578|P1|Participant Flow|Voriconazole Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
514893|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514894|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infection|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514895|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514896|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514897|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514898|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514899|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514900|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514901|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514902|NCT00721578|E1|Reported Event|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
514927|NCT00721500|E4|Reported Event|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
515280|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
514903|NCT00721539|B1|Baseline|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
514904|NCT00721539|P1|Participant Flow|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
514905|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
514906|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
514907|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
514908|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
514909|NCT00721539|E1|Reported Event|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
514910|NCT00721500|B1|Baseline|All Subjects|All subjects who enrolled and completed study.
514911|NCT00721500|P4|Participant Flow|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
514912|NCT00721500|P3|Participant Flow|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
514913|NCT00721500|P2|Participant Flow|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
514914|NCT00721500|P1|Participant Flow|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
514915|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
514916|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
514917|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
514918|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|Narafilcon A contact lens worn in both eyes.
514919|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
514920|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
514921|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
514922|NCT00721500|O1|Outcome|Narafilcon A|Narafilcon A contact lens worn in both eyes.
514923|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
514924|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
514925|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
514926|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|narafilcon A contact lens worn in both eyes.
515281|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
514928|NCT00721500|E3|Reported Event|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
514929|NCT00721500|E2|Reported Event|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
514930|NCT00721500|E1|Reported Event|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
514931|NCT00721409|B4|Baseline|Total|Total of all reporting groups
514932|NCT00721409|B3|Baseline|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514933|NCT00721409|B2|Baseline|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514934|NCT00721409|B1|Baseline|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
514935|NCT00721409|P3|Participant Flow|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514936|NCT00721409|P2|Participant Flow|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514937|NCT00721409|P1|Participant Flow|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
514938|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514939|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514940|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514941|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514942|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514943|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514944|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514945|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514946|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514947|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514948|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514949|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514950|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514951|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514952|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514953|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514954|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514955|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514956|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514957|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514958|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514959|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514960|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514961|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514962|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514963|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514964|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514965|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514966|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514967|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514968|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514969|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514970|NCT00721409|O4|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514971|NCT00721409|O3|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514972|NCT00721409|O2|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514973|NCT00721409|O1|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514974|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514975|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514976|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514977|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514978|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514979|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514981|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514982|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514983|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514984|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514985|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514986|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514987|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514988|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514989|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514990|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514991|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514992|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514993|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514994|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514995|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514996|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
514997|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
514998|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
514999|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515000|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515001|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515002|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
515003|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515004|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515005|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515006|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515007|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515008|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
515009|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515010|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515011|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515012|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515013|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515014|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
515015|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515016|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515017|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515018|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515019|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515020|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
515021|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515022|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515023|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
515024|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
515025|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
515026|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
515027|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
515028|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
515029|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515030|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
515031|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515032|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
515033|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515034|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
515035|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515036|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
515070|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515037|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515038|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
515039|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515040|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
515041|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515042|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515043|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515044|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515045|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515046|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515047|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
515048|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515049|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515050|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515051|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515052|NCT00721409|E7|Reported Event|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515053|NCT00721409|E6|Reported Event|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515054|NCT00721409|E5|Reported Event|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
515055|NCT00721409|E4|Reported Event|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515056|NCT00721409|E3|Reported Event|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
515057|NCT00721409|E2|Reported Event|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
515058|NCT00721409|E1|Reported Event|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
515059|NCT00721396|B5|Baseline|Total|Total of all reporting groups
515060|NCT00721396|B4|Baseline|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515061|NCT00721396|B3|Baseline|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515062|NCT00721396|B2|Baseline|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515063|NCT00721396|B1|Baseline|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515071|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515072|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515073|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515074|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515075|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515076|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515077|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515078|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515079|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515080|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515081|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515082|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515083|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515084|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515085|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515086|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515087|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515088|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515089|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515090|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515091|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
515092|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
515093|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
515094|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515095|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515096|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515097|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515098|NCT00721396|E4|Reported Event|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
515099|NCT00721396|E3|Reported Event|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
515100|NCT00721396|E2|Reported Event|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
515101|NCT00721396|E1|Reported Event|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
515102|NCT00721357|B3|Baseline|Total|Total of all reporting groups
515103|NCT00721357|B2|Baseline|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
515104|NCT00721357|B1|Baseline|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
515105|NCT00721357|P2|Participant Flow|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
515106|NCT00721357|P1|Participant Flow|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
515107|NCT00721357|O2|Outcome|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
528822|NCT00690755|E2|Reported Event|Group 2|Type 1 diabetes
515108|NCT00721357|O1|Outcome|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
515109|NCT00721357|E2|Reported Event|Group 2|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
515110|NCT00721357|E1|Reported Event|Group 1|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
515111|NCT00721279|B3|Baseline|Total|Total of all reporting groups
515112|NCT00721279|B2|Baseline|Pre-treated Patients|Patients that had been treated for RLS at baseline
515113|NCT00721279|B1|Baseline|De-novo Patients|Patients that had not been treated for RLS at baseline
515114|NCT00721279|P2|Participant Flow|Pre-treated Patients|Patients that had been treated for RLS at baseline
515115|NCT00721279|P1|Participant Flow|De-novo Patients|Patients that had not been treated for RLS at baseline
515116|NCT00721279|O1|Outcome|Overall|All Patients
515117|NCT00721279|O1|Outcome|Overall|All Patients
515118|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
515119|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
515120|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
515121|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
515122|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
515123|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
515124|NCT00721279|E2|Reported Event|Pre-treated Patients|Patients that had been treated for RLS at baseline
515125|NCT00721279|E1|Reported Event|De-novo Patients|Patients that had not been treated for RLS at baseline
515126|NCT00721253|B3|Baseline|Total|Total of all reporting groups
515127|NCT00721253|B2|Baseline|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
515128|NCT00721253|B1|Baseline|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
515129|NCT00721253|P3|Participant Flow|Tecnis MF|Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
515130|NCT00721253|P2|Participant Flow|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
515131|NCT00721253|P1|Participant Flow|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
515132|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
515133|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
515134|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
515135|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
515136|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
515137|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
515138|NCT00721253|E2|Reported Event|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
515139|NCT00721253|E1|Reported Event|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
515140|NCT00721227|B3|Baseline|Total|Total of all reporting groups
515141|NCT00721227|B2|Baseline|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
515142|NCT00721227|B1|Baseline|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
515143|NCT00721227|P2|Participant Flow|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
515144|NCT00721227|P1|Participant Flow|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
515145|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
515146|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
515147|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
515148|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
515149|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
515150|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
515151|NCT00721227|E2|Reported Event|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
515152|NCT00721227|E1|Reported Event|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
515153|NCT00721214|B1|Baseline|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515154|NCT00721214|P1|Participant Flow|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515155|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515195|NCT00721162|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515282|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
515156|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515157|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515158|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515159|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515160|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515161|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515162|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515163|NCT00721214|E1|Reported Event|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
515164|NCT00721188|B1|Baseline|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515165|NCT00721188|P1|Participant Flow|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515166|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515167|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515168|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515169|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515170|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515171|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515172|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515173|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515174|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515175|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515176|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515177|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515178|NCT00721188|E1|Reported Event|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
515179|NCT00721175|B3|Baseline|Total|Total of all reporting groups
515180|NCT00721175|B2|Baseline|Plastic Stent|plastic stent group
515181|NCT00721175|B1|Baseline|SEMS|self-expandable metal stent group
515182|NCT00721175|P2|Participant Flow|Plastic Stent|plastic stent group
515183|NCT00721175|P1|Participant Flow|SEMS|self-expandable metal stent group
515184|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
515185|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
515186|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
515187|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
515188|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
515189|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
515190|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
515191|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
515192|NCT00721175|E2|Reported Event|Plastic Stent|plastic stent group
515193|NCT00721175|E1|Reported Event|SEMS|self-expandable metal stent group
515194|NCT00721162|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515257|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
515196|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515197|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515198|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515199|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515200|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515201|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515202|NCT00721162|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
515203|NCT00721149|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515204|NCT00721149|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515205|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515206|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515207|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515208|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515209|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515210|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515211|NCT00721149|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
515212|NCT00721136|B5|Baseline|Total|Total of all reporting groups
515213|NCT00721136|B4|Baseline|High Risk Holding Warfarin|These high risk patients randomized to holding coumadin for 4-5 days and using a heparin transition for bridging.
515214|NCT00721136|B3|Baseline|High Risk Continuing Warfarin|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515215|NCT00721136|B2|Baseline|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
515216|NCT00721136|B1|Baseline|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515217|NCT00721136|P4|Participant Flow|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
515218|NCT00721136|P3|Participant Flow|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515219|NCT00721136|P2|Participant Flow|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
515220|NCT00721136|P1|Participant Flow|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515221|NCT00721136|O4|Outcome|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
515222|NCT00721136|O3|Outcome|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515223|NCT00721136|O2|Outcome|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
515224|NCT00721136|O1|Outcome|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515225|NCT00721136|O4|Outcome|High Risk Holding Warfarin (Coumadin)|These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
515226|NCT00721136|O3|Outcome|High Risk Continuing Warfarin (Coumadin)|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515227|NCT00721136|O2|Outcome|Moderate Risk Holding Warfarin (Coumadin)|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
515228|NCT00721136|O1|Outcome|Moderate Risk Continuing Warfarin (Coumadin)|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515229|NCT00721136|O4|Outcome|High Risk Holding Warfarin|These high risk patients randomized to holding warfarin for 4-
515230|NCT00721136|O3|Outcome|High Risk Continuing Warfarin|"High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.~These patients continue warfarin through the procedure: The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515231|NCT00721136|O2|Outcome|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
515232|NCT00721136|O1|Outcome|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure:The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515233|NCT00721136|E4|Reported Event|High Risk Holding Warfarin|"These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.~These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging."
515234|NCT00721136|E3|Reported Event|High Risk Continuing Warfarin|High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.
515235|NCT00721136|E2|Reported Event|Moderate Risk Holding Warfarin|"Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).~These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure."
515236|NCT00721136|E1|Reported Event|Moderate Risk Continuing Warfarin|"Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.~These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period."
515237|NCT00721123|B1|Baseline|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
515238|NCT00721123|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
515239|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
515240|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
515241|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
515242|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
515243|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
515244|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
515245|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
515246|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
515247|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
515248|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
515249|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
515250|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
515251|NCT00721123|O1|Outcome|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
515252|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264 (Total PY=731.93).
515253|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192 (Total PY=388.25).
515254|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144 (Total PY=410.93).
515255|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96 (Total PY=444.49).
515256|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48 (Total PY=486.34).
515283|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
515284|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
515285|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
515286|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
515287|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
515288|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
515289|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
515290|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
515291|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
515292|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
515293|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
515294|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
515295|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
515296|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
515297|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
515298|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
515299|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
515300|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
515301|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
515302|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
515303|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
515304|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
515305|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264.
515306|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192.
515307|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144.
515308|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96.
515309|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48.
515310|NCT00721123|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
515311|NCT00721110|B5|Baseline|Total|Total of all reporting groups
515312|NCT00721110|B4|Baseline|Placebo|"A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine or Lidocaine not given"
515313|NCT00721110|B3|Baseline|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515314|NCT00721110|B2|Baseline|Lidocaine|"Intravenous lidocaine Group - A lidocaine is administered intravenously through out surgery and 24 hours after surgery.~Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours."
515315|NCT00721110|B1|Baseline|Lidocaine/Ketamine|"Intravenous Lidocaine and Ketamine Group -~Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters."
515316|NCT00721110|P4|Participant Flow|Placebo|"A placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine or lidocaine not given"
515317|NCT00721110|P3|Participant Flow|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515318|NCT00721110|P2|Participant Flow|Lidocaine|Intravenous lidocaine Group - Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.
515319|NCT00721110|P1|Participant Flow|Lidocaine/Ketamine|"Intravenous Lidocaine + Ketamine Group~Lidocaine was given as a bolus (1.5 mg/kg), followed by an infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours.~Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours.~Medication doses were based on actual patient body weight to a maximum of 150% of ideal body weight based on the formula: 49 kg + 0.6 kg for each centimeter of height exceeding 152 centimeters"
515320|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine not given"
515321|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515322|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.~Placebo boluses and infusions will be substituted for the lidocaine"
515323|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
515324|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine not given"
515325|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515326|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.~Placebo boluses and infusions will be substituted for the lidocaine"
515327|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
515328|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine not given"
515329|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515330|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.~Placebo boluses and infusions will be substituted for the lidocaine"
515331|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
515332|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine not given"
515333|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515334|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.~Placebo boluses and infusions will be substituted for the lidocaine"
515335|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
515336|NCT00721110|O4|Outcome|Nonketamine|"A ketamine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.~A placebo infusion will be substituted for the ketamine not given"
515337|NCT00721110|O3|Outcome|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515338|NCT00721110|O2|Outcome|Nonlidocaine|"Intravenous Nonlidocaine Group - A lidocaine placebo is administered intravenously through out surgery and 24 hours after surgery.~Placebo boluses and infusions will be substituted for the lidocaine"
515339|NCT00721110|O1|Outcome|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
515340|NCT00721110|E4|Reported Event|Ketamine + Lidocaine|both ketamine and Lidocaine administered intravenously throughout surgery and during the 24 hours after surgery.
515341|NCT00721110|E3|Reported Event|Ketamine|"Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery~Ketamine: Upon induction of anesthesia, a bolus of ketamine (0.25mg/kg) will be given followed by an infusion of ketamine (0.25mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively."
515342|NCT00721110|E2|Reported Event|Placebo|placebo is administered intravenously through out surgery and 24 hours after surgery.
515343|NCT00721110|E1|Reported Event|Lidocaine|"Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery~Lidocaine: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively."
515344|NCT00720941|B3|Baseline|Total|Total of all reporting groups
515345|NCT00720941|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515346|NCT00720941|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515347|NCT00720941|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515348|NCT00720941|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515349|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515350|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515351|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515352|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515353|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515354|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515355|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515356|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515357|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515358|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515359|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515360|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515361|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515362|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515363|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515364|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515365|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515366|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515367|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515368|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515369|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515370|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515371|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515372|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515373|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515374|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515375|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515376|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515377|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515378|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515379|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515380|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515381|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515382|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515383|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515384|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515385|NCT00720941|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515386|NCT00720941|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
515387|NCT00720798|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515388|NCT00720798|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515389|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515390|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515391|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515392|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515393|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515394|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515395|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515396|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515397|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515398|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515399|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515400|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515401|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515402|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515403|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515404|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515405|NCT00720798|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
515406|NCT00720759|B5|Baseline|Total|Total of all reporting groups
515407|NCT00720759|B4|Baseline|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
515408|NCT00720759|B3|Baseline|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
515553|NCT00720382|B2|Baseline|Nasonex®|Mometasone furoate 200 mcg
515409|NCT00720759|B2|Baseline|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515410|NCT00720759|B1|Baseline|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515411|NCT00720759|P4|Participant Flow|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
515412|NCT00720759|P3|Participant Flow|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
515413|NCT00720759|P2|Participant Flow|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515414|NCT00720759|P1|Participant Flow|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515415|NCT00720759|O4|Outcome|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
515416|NCT00720759|O3|Outcome|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
515417|NCT00720759|O2|Outcome|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515418|NCT00720759|O1|Outcome|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515419|NCT00720759|E4|Reported Event|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
515420|NCT00720759|E3|Reported Event|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
515421|NCT00720759|E2|Reported Event|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515422|NCT00720759|E1|Reported Event|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
515423|NCT00720629|B1|Baseline|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515424|NCT00720629|P1|Participant Flow|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515425|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515426|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515427|NCT00720629|O2|Outcome|5 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
515428|NCT00720629|O1|Outcome|2 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
515429|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515430|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515431|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515432|NCT00720629|E1|Reported Event|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
515433|NCT00720499|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way cross-over study. The two treatment periods were separated by a wash-out period of 14 days during which they received open-label Tiotropium 5 mcg. The 2 treatments, administered once daily in the morning via the respimat inhaler, were :~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
515434|NCT00720499|P2|Participant Flow|Tio+Olo5/5µg / Tio+Olo5/2µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
515435|NCT00720499|P1|Participant Flow|Tio+Olo 5/2µg / Tio+Olo5/5µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
515436|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515437|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515438|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515439|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515440|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515441|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515442|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515443|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515444|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515445|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515446|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515447|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515448|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515449|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515450|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515451|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515452|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515453|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515454|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515455|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515456|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515457|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515458|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515459|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515460|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515461|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515462|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515463|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515464|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515554|NCT00720382|B1|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
515555|NCT00720382|P2|Participant Flow|Nasonex®|Mometasone furoate 200 mcg
515465|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515466|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515467|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515468|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515469|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515470|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515471|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515472|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515473|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515474|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515475|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515476|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515477|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515478|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515479|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515480|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515481|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515482|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515483|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515484|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515485|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515486|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515487|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515488|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515489|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515490|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515491|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515492|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515493|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515494|NCT00720499|E2|Reported Event|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515495|NCT00720499|E1|Reported Event|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
515496|NCT00720473|B3|Baseline|Total|Total of all reporting groups
515497|NCT00720473|B2|Baseline|Control Subjects|Age matched controls without BPD
515498|NCT00720473|B1|Baseline|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515499|NCT00720473|P2|Participant Flow|B: Healthy Control|No Intervention
515500|NCT00720473|P1|Participant Flow|A: BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515501|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515502|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515503|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515504|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515505|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515506|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515507|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515508|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515509|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515510|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515511|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515512|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515513|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515514|NCT00720473|O1|Outcome|A: Other|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515515|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515516|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515517|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515518|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515519|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
515520|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
515521|NCT00720473|E2|Reported Event|BPD Subjects|
515522|NCT00720473|E1|Reported Event|Control Subjects|Age matched controls without BPD
515523|NCT00720434|B5|Baseline|Total|Total of all reporting groups
515524|NCT00720434|B4|Baseline|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515525|NCT00720434|B3|Baseline|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515526|NCT00720434|B2|Baseline|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515527|NCT00720434|B1|Baseline|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
515556|NCT00720382|P1|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
515528|NCT00720434|P4|Participant Flow|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515529|NCT00720434|P3|Participant Flow|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515530|NCT00720434|P2|Participant Flow|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515531|NCT00720434|P1|Participant Flow|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
515532|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515533|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515534|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515535|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
515536|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515537|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515538|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515539|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
515557|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
515540|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515541|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515542|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515543|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
515544|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515545|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515546|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515547|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
515548|NCT00720434|E4|Reported Event|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515549|NCT00720434|E3|Reported Event|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515550|NCT00720434|E2|Reported Event|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
515551|NCT00720434|E1|Reported Event|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
515552|NCT00720382|B3|Baseline|Total|Total of all reporting groups
515558|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
515559|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
515560|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
515561|NCT00720382|E2|Reported Event|Nasonex®|Mometasone furoate 200 mcg
515562|NCT00720382|E1|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
515563|NCT00720369|B3|Baseline|Total|Total of all reporting groups
515564|NCT00720369|B2|Baseline|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
515565|NCT00720369|B1|Baseline|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
515566|NCT00720369|P2|Participant Flow|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
515567|NCT00720369|P1|Participant Flow|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
515568|NCT00720369|O2|Outcome|Healthy Controls|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
515569|NCT00720369|O1|Outcome|CoQ10|Open Label Study
515570|NCT00720369|O2|Outcome|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group.
515571|NCT00720369|O1|Outcome|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated.
515572|NCT00720369|E2|Reported Event|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
515573|NCT00720369|E1|Reported Event|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
515574|NCT00720343|B1|Baseline|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
515575|NCT00720343|P1|Participant Flow|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
515576|NCT00720343|O2|Outcome|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
515577|NCT00720343|O1|Outcome|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
515578|NCT00720343|E2|Reported Event|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
515579|NCT00720343|E1|Reported Event|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
515580|NCT00720330|B4|Baseline|Total|Total of all reporting groups
515581|NCT00720330|B3|Baseline|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515582|NCT00720330|B2|Baseline|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515583|NCT00720330|B1|Baseline|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515584|NCT00720330|P3|Participant Flow|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515585|NCT00720330|P2|Participant Flow|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515586|NCT00720330|P1|Participant Flow|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515587|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515588|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515589|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515794|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
515590|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515591|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515592|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515593|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515594|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515595|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515596|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515597|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515598|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515599|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515600|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515601|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515602|NCT00720330|E3|Reported Event|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
515603|NCT00720330|E2|Reported Event|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
515604|NCT00720330|E1|Reported Event|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
515605|NCT00720278|B4|Baseline|Total|Total of all reporting groups
515606|NCT00720278|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515607|NCT00720278|B2|Baseline|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515608|NCT00720278|B1|Baseline|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515609|NCT00720278|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515610|NCT00720278|P2|Participant Flow|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515611|NCT00720278|P1|Participant Flow|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515612|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515613|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515614|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515615|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515616|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515617|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515618|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515619|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515620|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515621|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515622|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515623|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515624|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515625|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515626|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515627|NCT00720278|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515628|NCT00720278|E2|Reported Event|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515629|NCT00720278|E1|Reported Event|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
515630|NCT00720226|B3|Baseline|Total|Total of all reporting groups
515631|NCT00720226|B2|Baseline|Placebo|Placebo 1 tablet daily
515632|NCT00720226|B1|Baseline|Losartan|Losartan 100 mg daily
515633|NCT00720226|P2|Participant Flow|Placebo|"Placebo 1 pill daily~Placebo: Placebo pill daily"
515634|NCT00720226|P1|Participant Flow|Losartan|"Losartan 100 mg daily~Losartan: Losartan 100 mg daily"
515635|NCT00720226|O2|Outcome|Placebo|Placebo: Placebo pill daily (Participants with 5-35% emphysema)
515636|NCT00720226|O1|Outcome|Losartan|Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)
515637|NCT00720226|O2|Outcome|Placebo|Placebo: Placebo pill daily (Participants with 5-35% emphysema)
515638|NCT00720226|O1|Outcome|Losartan|Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)
515639|NCT00720226|E2|Reported Event|Placebo|"Placebo 1 pill daily~Placebo: Placebo pill daily"
515640|NCT00720226|E1|Reported Event|Losartan 100 mg Daily|"Losartan 100 mg daily~Losartan: Losartan 100 mg daily"
515641|NCT00720122|B1|Baseline|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
515642|NCT00720122|P1|Participant Flow|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
515643|NCT00720122|O1|Outcome|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
515644|NCT00720122|E1|Reported Event|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
515645|NCT00720109|B1|Baseline|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
515646|NCT00720109|P3|Participant Flow|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
515647|NCT00720109|P2|Participant Flow|Standard-risk|Based on Minimal Residual Disease, less than 1%.
515648|NCT00720109|P1|Participant Flow|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
515649|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
515650|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
515651|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
515652|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
515653|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
515654|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
515655|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
515656|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
515689|NCT00720057|B1|Baseline|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515795|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
515657|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
515658|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib
515659|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
515660|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
515661|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
515662|NCT00720109|E3|Reported Event|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
515663|NCT00720109|E2|Reported Event|Standard-risk|Based on Minimal Residual Disease, less than 1%.
515664|NCT00720109|E1|Reported Event|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
515665|NCT00720096|B3|Baseline|Total|Total of all reporting groups
515666|NCT00720096|B2|Baseline|Topotecan|Topotecan - Chemotherapy single agent systemic.
515667|NCT00720096|B1|Baseline|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
515668|NCT00720096|P2|Participant Flow|Topotecan|Topotecan - Chemotherapy single agent systemic.
515669|NCT00720096|P1|Participant Flow|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
515670|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
515671|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
515672|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
515673|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
515674|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
515675|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
515676|NCT00720096|E2|Reported Event|Topotecan|Topotecan - Chemotherapy single agent systemic.
515677|NCT00720096|E1|Reported Event|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
515678|NCT00720083|B3|Baseline|Total|Total of all reporting groups
515679|NCT00720083|B2|Baseline|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515680|NCT00720083|B1|Baseline|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515681|NCT00720083|P2|Participant Flow|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515682|NCT00720083|P1|Participant Flow|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515683|NCT00720083|O2|Outcome|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515684|NCT00720083|O1|Outcome|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515685|NCT00720083|E2|Reported Event|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515686|NCT00720083|E1|Reported Event|RT+ Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
515687|NCT00720057|B3|Baseline|Total|Total of all reporting groups
515688|NCT00720057|B2|Baseline|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515789|NCT00719810|B2|Baseline|Delafloxacin 450 mg IV q12h|
515690|NCT00720057|P2|Participant Flow|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515691|NCT00720057|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515692|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515693|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515694|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515695|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515696|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515697|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515698|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515699|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515700|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515701|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515702|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515703|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515704|NCT00720057|E2|Reported Event|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515705|NCT00720057|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
515706|NCT00719953|B1|Baseline|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
515707|NCT00719953|P1|Participant Flow|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
515708|NCT00719953|O1|Outcome|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
515709|NCT00719953|E1|Reported Event|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
515710|NCT00719914|B3|Baseline|Total|Total of all reporting groups
515711|NCT00719914|B2|Baseline|Bolus of Normal Saline|Intra-coronary injection of normal saline.
515712|NCT00719914|B1|Baseline|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
515713|NCT00719914|P2|Participant Flow|Bolus of Normal Saline|Intracoronary injection of normal saline.
515714|NCT00719914|P1|Participant Flow|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
515715|NCT00719914|O2|Outcome|Bolus of Normal Saline|Intra-coronary injection of normal saline.
515716|NCT00719914|O1|Outcome|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
515717|NCT00719914|E2|Reported Event|Bolus of Normal Saline|Intra-coronary injection of normal saline.
515718|NCT00719914|E1|Reported Event|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
515719|NCT00719901|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515720|NCT00719901|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515721|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515722|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515723|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515724|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515725|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515726|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515727|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515728|NCT00719901|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
515729|NCT00719862|B3|Baseline|Total|Total of all reporting groups
515730|NCT00719862|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515731|NCT00719862|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515732|NCT00719862|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515733|NCT00719862|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515734|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515735|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515736|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515737|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515738|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515739|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515740|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515741|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515742|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515743|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515744|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515745|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515746|NCT00719862|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
515747|NCT00719862|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
515748|NCT00719849|B3|Baseline|Total|Total of all reporting groups
515749|NCT00719849|B2|Baseline|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
515750|NCT00719849|B1|Baseline|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
515751|NCT00719849|P2|Participant Flow|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
515752|NCT00719849|P1|Participant Flow|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
515753|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515754|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515755|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515756|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515757|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515758|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515759|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515760|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515761|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515762|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515763|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515764|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515765|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515766|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515767|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515768|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515769|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515770|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515771|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515790|NCT00719810|B1|Baseline|Delafloxacin 300 mg IV q12h|
515791|NCT00719810|P3|Participant Flow|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
515792|NCT00719810|P2|Participant Flow|Delafloxacin 450 mg IV q12h|
515772|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515773|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515774|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515775|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515776|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515777|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515778|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515779|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515780|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515781|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515782|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515783|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515784|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515785|NCT00719849|E2|Reported Event|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515786|NCT00719849|E1|Reported Event|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
515787|NCT00719810|B4|Baseline|Total|Total of all reporting groups
515788|NCT00719810|B3|Baseline|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
515797|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
515798|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
515799|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
515800|NCT00719810|E3|Reported Event|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
515801|NCT00719810|E2|Reported Event|Delafloxacin 450 mg IV q12h|
515802|NCT00719810|E1|Reported Event|Delafloxacin 300 mg IV q12h|
515803|NCT00719732|B1|Baseline|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
515804|NCT00719732|P1|Participant Flow|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
515805|NCT00719732|O1|Outcome|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
515806|NCT00719732|E1|Reported Event|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
515807|NCT00719706|B3|Baseline|Total|Total of all reporting groups
515808|NCT00719706|B2|Baseline|Placebo|Participants taking placebo.
515809|NCT00719706|B1|Baseline|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515810|NCT00719706|P2|Participant Flow|Placebo|Participants taking placebo.
515811|NCT00719706|P1|Participant Flow|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515812|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
515813|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515814|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
515815|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515816|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
515817|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515818|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
515819|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515820|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
515821|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515822|NCT00719706|E2|Reported Event|Placebo|Participants taking placebo.
515823|NCT00719706|E1|Reported Event|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
515824|NCT00719680|B1|Baseline|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
515825|NCT00719680|P1|Participant Flow|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
515826|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515827|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515828|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515829|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515830|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515831|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515832|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515833|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515834|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515835|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515836|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515837|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515968|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515838|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515839|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515840|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515841|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515842|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
515843|NCT00719680|E1|Reported Event|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
515844|NCT00719615|B4|Baseline|Total|Total of all reporting groups
515845|NCT00719615|B3|Baseline|Active Thyroid Cancer|
515846|NCT00719615|B2|Baseline|Thyroid Cancer in Remission|
515847|NCT00719615|B1|Baseline|Thyroid Nodules|
515848|NCT00719615|P3|Participant Flow|Active Thyroid Cancer|
515849|NCT00719615|P2|Participant Flow|Thyroid Cancer in Remission|
515850|NCT00719615|P1|Participant Flow|Thyroid Nodules|
515851|NCT00719615|O3|Outcome|Active Thyroid Cancer|
515852|NCT00719615|O2|Outcome|Thyroid Cancer in Remission|
515853|NCT00719615|O1|Outcome|Thyroid Nodules|
515854|NCT00719615|E3|Reported Event|Active Thyroid Cancer|
515855|NCT00719615|E2|Reported Event|Thyroid Cancer in Remission|
515856|NCT00719615|E1|Reported Event|Thyroid Nodules|
515857|NCT00719576|B3|Baseline|Total|Total of all reporting groups
515858|NCT00719576|B2|Baseline|Microfracture|Microfracture
515859|NCT00719576|B1|Baseline|MACI|autologous cultured chondrocytes on porcine collagen membrane
515860|NCT00719576|P2|Participant Flow|Microfracture|"Microfracture~Microfracture: Microfracture"
515861|NCT00719576|P1|Participant Flow|MACI|autologous cultured chondrocytes on porcine collagen membrane
515862|NCT00719576|O2|Outcome|Microfracture|"Microfracture~Microfracture: Microfracture"
515863|NCT00719576|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
515864|NCT00719576|O2|Outcome|Microfracture|Microfracture
515865|NCT00719576|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
515866|NCT00719576|O2|Outcome|Microfracture|Microfracture: Microfracture
515867|NCT00719576|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
515868|NCT00719576|O2|Outcome|Microfracture|Microfracture: Microfracture
515869|NCT00719576|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
515870|NCT00719576|O2|Outcome|Microfracture|Microfracture: Microfracture
515871|NCT00719576|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
515872|NCT00719576|O2|Outcome|Microfracture|"Microfracture~Microfracture: Microfracture"
515873|NCT00719576|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
515874|NCT00719576|O2|Outcome|Microfracture|"Microfracture~Microfracture: Microfracture"
515875|NCT00719576|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane
515876|NCT00719576|E2|Reported Event|Microfracture|Microfracture
515877|NCT00719576|E1|Reported Event|MACI|autologous cultured chondrocytes on porcine collagen membrane
515878|NCT00719563|B3|Baseline|Total|Total of all reporting groups
515879|NCT00719563|B2|Baseline|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515880|NCT00719563|B1|Baseline|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515881|NCT00719563|P2|Participant Flow|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515882|NCT00719563|P1|Participant Flow|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515883|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515884|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515885|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515886|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515887|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515888|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515889|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515890|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
516890|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
515891|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515892|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515893|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515894|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515895|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515896|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515897|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515898|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515899|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515900|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515901|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515902|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515903|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515904|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515905|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..
515906|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515907|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515908|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515909|NCT00719563|E2|Reported Event|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515910|NCT00719563|E1|Reported Event|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
515911|NCT00719537|B3|Baseline|Total|Total of all reporting groups
515912|NCT00719537|B2|Baseline|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
515913|NCT00719537|B1|Baseline|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
515914|NCT00719537|P2|Participant Flow|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
515915|NCT00719537|P1|Participant Flow|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
515916|NCT00719537|O2|Outcome|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
515917|NCT00719537|O1|Outcome|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
515918|NCT00719537|E2|Reported Event|Aspirin and Progesterone|Aspirin and progesterone: aspirin 81 mg once a day oral progesterone 200mg twice daily
515919|NCT00719537|E1|Reported Event|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo
515920|NCT00719472|B1|Baseline|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515921|NCT00719472|P1|Participant Flow|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515922|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515923|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515924|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515925|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515926|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515927|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515928|NCT00719472|E1|Reported Event|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
515929|NCT00719355|B3|Baseline|Total|Total of all reporting groups
515930|NCT00719355|B2|Baseline|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
515931|NCT00719355|B1|Baseline|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
515932|NCT00719355|P2|Participant Flow|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
515933|NCT00719355|P1|Participant Flow|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
515934|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
515935|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
515936|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
515937|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
515938|NCT00719355|E2|Reported Event|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
515939|NCT00719355|E1|Reported Event|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
515940|NCT00719329|B4|Baseline|Total|Total of all reporting groups
515941|NCT00719329|B3|Baseline|Dry Cord Care|Dry cord care, as recommended by WHO
515942|NCT00719329|B2|Baseline|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
515943|NCT00719329|B1|Baseline|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
515944|NCT00719329|P3|Participant Flow|Dry Cord Care|Dry cord care, as recommended by WHO
515945|NCT00719329|P2|Participant Flow|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
515946|NCT00719329|P1|Participant Flow|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
515947|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
515948|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
515949|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
515950|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
515951|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
515952|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
515953|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
515954|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
515955|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
515956|NCT00719329|E3|Reported Event|Dry Cord Care|Dry cord care, as recommended by WHO
515957|NCT00719329|E2|Reported Event|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
515958|NCT00719329|E1|Reported Event|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
515959|NCT00719264|B3|Baseline|Total|Total of all reporting groups
515960|NCT00719264|B2|Baseline|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515961|NCT00719264|B1|Baseline|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515962|NCT00719264|P2|Participant Flow|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515963|NCT00719264|P1|Participant Flow|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515964|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515965|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515966|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515967|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
516891|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
515969|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515970|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515971|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515972|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515973|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515974|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515975|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515976|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515977|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515978|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515979|NCT00719264|E2|Reported Event|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
515980|NCT00719264|E1|Reported Event|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
515981|NCT00719212|B1|Baseline|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515982|NCT00719212|P1|Participant Flow|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515983|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515984|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515985|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515986|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515987|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515988|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515989|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515990|NCT00719212|E1|Reported Event|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
515991|NCT00719186|B3|Baseline|Total|Total of all reporting groups
515992|NCT00719186|B2|Baseline|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
515993|NCT00719186|B1|Baseline|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
515994|NCT00719186|P2|Participant Flow|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
515995|NCT00719186|P1|Participant Flow|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
515996|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
528823|NCT00690755|E1|Reported Event|Group 1|Diabetics
515997|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
515998|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
515999|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516000|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516001|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516002|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516003|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516004|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516005|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516006|NCT00719186|E2|Reported Event|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516007|NCT00719186|E1|Reported Event|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
516008|NCT00719160|B1|Baseline|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
516009|NCT00719160|P2|Participant Flow|Intervention Placebo First/Esomeprazole Second|In this group this group received the placebo first and then the intervention
516010|NCT00719160|P1|Participant Flow|Intervention Esomeprazole First/Placebo Second|In this group this group received the intervention first and then the placebo
516011|NCT00719160|O2|Outcome|Placebo|Placebo 20 mg twice a day given as either the first or second intervention.
516012|NCT00719160|O1|Outcome|Esomeprazole Study Drug|Esomeprazole 20 mg twice daily given as either the first or second intervention
516013|NCT00719160|O2|Outcome|Placebo|Placebo administered twice daily in either first or second intervention
516014|NCT00719160|O1|Outcome|Esomeprazole|Esomeprazoled administered twice daily in either first or second intervention period
516015|NCT00719160|E1|Reported Event|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
516016|NCT00719134|B1|Baseline|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
516017|NCT00719134|P1|Participant Flow|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
516018|NCT00719134|O1|Outcome|All Participants|
516019|NCT00719134|O1|Outcome|All Participants|
516020|NCT00719134|E2|Reported Event|Placebo|
516021|NCT00719134|E1|Reported Event|Maxalt|
516022|NCT00719043|B8|Baseline|Total|Total of all reporting groups
516023|NCT00719043|B7|Baseline|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516024|NCT00719043|B6|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516025|NCT00719043|B5|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516172|NCT00718887|O2|Outcome|Adeforvi, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516557|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
516026|NCT00719043|B4|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516027|NCT00719043|B3|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516028|NCT00719043|B2|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516029|NCT00719043|B1|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516030|NCT00719043|P7|Participant Flow|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516031|NCT00719043|P6|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516032|NCT00719043|P5|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516033|NCT00719043|P4|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516034|NCT00719043|P3|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516035|NCT00719043|P2|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516036|NCT00719043|P1|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516037|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516038|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516039|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516040|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516041|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516042|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516043|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516044|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516045|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516046|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516047|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516048|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516061|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516049|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516050|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516051|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516052|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516053|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516054|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516055|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516056|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516057|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516058|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516059|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516060|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516169|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516170|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516062|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516063|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516064|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516065|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516066|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516067|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516068|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516069|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516070|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516071|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516072|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516073|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516074|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516075|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516076|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516077|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516078|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516079|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516080|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516081|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516082|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516083|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516084|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516085|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516086|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516087|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516088|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516089|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516090|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516091|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516092|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516093|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516094|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516095|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516096|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516097|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516098|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516099|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516100|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516101|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516102|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516103|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516104|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516105|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516106|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516107|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516108|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516109|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516110|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516111|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516112|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516113|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516114|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516115|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516116|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516117|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516118|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516119|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516120|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516121|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516122|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516123|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516124|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516125|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516892|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
516126|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516127|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516128|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516129|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516130|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516131|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516132|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516133|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516134|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516135|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516136|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516137|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516138|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516139|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516140|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516141|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516142|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516143|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516144|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516145|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516146|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516147|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516148|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516149|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516171|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516150|NCT00719043|E7|Reported Event|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
516151|NCT00719043|E6|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516152|NCT00719043|E5|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516153|NCT00719043|E4|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516154|NCT00719043|E3|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516155|NCT00719043|E2|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516156|NCT00719043|E1|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
516157|NCT00718887|B3|Baseline|Total|Total of all reporting groups
516158|NCT00718887|B2|Baseline|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516159|NCT00718887|B1|Baseline|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516160|NCT00718887|P2|Participant Flow|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516161|NCT00718887|P1|Participant Flow|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516162|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516163|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516164|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516165|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516166|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516167|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516168|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516173|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516174|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516175|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516176|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516177|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516178|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516179|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD) for a maximum of 52 weeks.
516180|NCT00718887|E2|Reported Event|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
516181|NCT00718887|E1|Reported Event|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
516182|NCT00718861|B3|Baseline|Total|Total of all reporting groups
516183|NCT00718861|B2|Baseline|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516184|NCT00718861|B1|Baseline|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516185|NCT00718861|P2|Participant Flow|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516186|NCT00718861|P1|Participant Flow|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516187|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516188|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516189|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516190|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516191|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516192|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516193|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516194|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516195|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516196|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516197|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516198|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516199|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516200|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516201|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516202|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516203|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516204|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516205|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516206|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516207|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516208|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516209|NCT00718861|E2|Reported Event|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
516210|NCT00718861|E1|Reported Event|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
516211|NCT00718809|B3|Baseline|Total|Total of all reporting groups
516212|NCT00718809|B2|Baseline|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516213|NCT00718809|B1|Baseline|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516214|NCT00718809|P2|Participant Flow|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516215|NCT00718809|P1|Participant Flow|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516216|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516217|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516218|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516219|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516220|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516221|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516222|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516223|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516224|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516225|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516226|NCT00718809|E2|Reported Event|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516227|NCT00718809|E1|Reported Event|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
516228|NCT00718770|B1|Baseline|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
516229|NCT00718770|P1|Participant Flow|Bexarotene|"Open label - all patients received the intervention~Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2."
516230|NCT00718770|O1|Outcome|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
516333|NCT00718328|E2|Reported Event|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
516231|NCT00718770|E1|Reported Event|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
516232|NCT00718718|B8|Baseline|Total|Total of all reporting groups
516233|NCT00718718|B7|Baseline|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516234|NCT00718718|B6|Baseline|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516235|NCT00718718|B5|Baseline|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516236|NCT00718718|B4|Baseline|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
516237|NCT00718718|B3|Baseline|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
516238|NCT00718718|B2|Baseline|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22.
516239|NCT00718718|B1|Baseline|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
516240|NCT00718718|P10|Participant Flow|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516241|NCT00718718|P9|Participant Flow|Part B - Sirukumab 50mg q4w|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
516242|NCT00718718|P8|Participant Flow|Part B - Sirukumab 100mg q4w|Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
516243|NCT00718718|P7|Participant Flow|Part B - Sirukumab 100mg q2w|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
516244|NCT00718718|P6|Participant Flow|Part B - Placebo Then Sirukumab 100 mg q2 Weeks|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
516245|NCT00718718|P5|Participant Flow|Part B - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
516246|NCT00718718|P4|Participant Flow|Part A - Sirukumab Then Placebo (Wk 12 to End of Study)|Participants received placebo at Weeks 12 and q2w through Week 22.
516247|NCT00718718|P3|Participant Flow|Part A - Sirukumab (Wk 0-Wk 12)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
516248|NCT00718718|P2|Participant Flow|Part A - Placebo Then Sirukumab (Wk 12 to End of Study)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
516249|NCT00718718|P1|Participant Flow|Part A - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks.
516250|NCT00718718|O7|Outcome|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
516251|NCT00718718|O6|Outcome|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
516252|NCT00718718|O5|Outcome|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516253|NCT00718718|O4|Outcome|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516254|NCT00718718|O3|Outcome|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516255|NCT00718718|O2|Outcome|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
516256|NCT00718718|O1|Outcome|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
516257|NCT00718718|O5|Outcome|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516258|NCT00718718|O4|Outcome|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516259|NCT00718718|O3|Outcome|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516260|NCT00718718|O2|Outcome|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
516261|NCT00718718|O1|Outcome|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
516262|NCT00718718|O2|Outcome|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
516263|NCT00718718|O1|Outcome|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
516264|NCT00718718|O2|Outcome|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
516265|NCT00718718|O1|Outcome|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
516266|NCT00718718|O7|Outcome|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516267|NCT00718718|O6|Outcome|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516268|NCT00718718|O5|Outcome|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516269|NCT00718718|O4|Outcome|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
516270|NCT00718718|O3|Outcome|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
516271|NCT00718718|O2|Outcome|Part A: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
516272|NCT00718718|O1|Outcome|Part A: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
516273|NCT00718718|O5|Outcome|Part B: Sirukumab 25 mg q4 Weeks|Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516274|NCT00718718|O4|Outcome|Part B: Sirukumab 50 mg q4 Weeks|Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516275|NCT00718718|O3|Outcome|Part B: Sirukumab 100 mg q4 Weeks|Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
516276|NCT00718718|O2|Outcome|Part B: Sirukumab 100 mg q2 Weeks|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
516277|NCT00718718|O1|Outcome|Part B: Placebo|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
516278|NCT00718718|E10|Reported Event|Part B - Sirukumab 25mg q4w|Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
516279|NCT00718718|E9|Reported Event|Part B - Sirukumab 50mg q4w|Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
516280|NCT00718718|E8|Reported Event|Part B - Sirukumab 100mg q4w|Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
516281|NCT00718718|E7|Reported Event|Part B - Sirukumab 100mg q2w|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
516282|NCT00718718|E6|Reported Event|Part B - Placebo Then Sirukumab 100 mg q2 Weeks|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24.
516283|NCT00718718|E5|Reported Event|Part B - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
516284|NCT00718718|E4|Reported Event|Part A - Sirukumab Then Placebo (Wk 12 to End of Study)|Participants received placebo at Weeks 12 and q2w through Week 22.
516285|NCT00718718|E3|Reported Event|Part A - Sirukumab (Wk 0-Wk 12)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
516286|NCT00718718|E2|Reported Event|Part A - Placebo Then Sirukumab (Wk 12 to End of Study)|Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
516287|NCT00718718|E1|Reported Event|Part A - Placebo (Wk 0-Wk 12)|Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks
516288|NCT00718640|B1|Baseline|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516289|NCT00718640|P1|Participant Flow|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516334|NCT00718328|E1|Reported Event|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
516335|NCT00718315|B4|Baseline|Total|Total of all reporting groups
516290|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516291|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516292|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516293|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516294|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516295|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516296|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516297|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516298|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516299|NCT00718640|E1|Reported Event|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
516300|NCT00718523|B3|Baseline|Total|Total of all reporting groups
516301|NCT00718523|B2|Baseline|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
516302|NCT00718523|B1|Baseline|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
516303|NCT00718523|P2|Participant Flow|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
516304|NCT00718523|P1|Participant Flow|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
516305|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
516306|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
516307|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
516308|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
516309|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
516310|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
516311|NCT00718523|E2|Reported Event|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
516312|NCT00718523|E1|Reported Event|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
516313|NCT00718510|B3|Baseline|Total|Total of all reporting groups
516314|NCT00718510|B2|Baseline|Placebo Treatment First, L-arginine Treatment Second|The trial participants received the placebo capsules (matching L-arginine 500mg) 6 g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received L-arginine (500mg capsules) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
516315|NCT00718510|B1|Baseline|L-arginine Treatment First, Placebo Treatment Second|The trial participants received 6 g p.o. (3 g twice per day at 0800h and 2000h) of L-arginine 500mg capsules for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received placebo capsules (matching L-arginine 500mg) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
516316|NCT00718510|P2|Participant Flow|Placebo Treatment First, L-arginine Treatment Second|The trial participants received the placebo capsules (matching L-arginine 500mg) 6 g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received L-arginine (500mg capsules) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
516317|NCT00718510|P1|Participant Flow|L-arginine Treatment First, Placebo Treatment Second|The trial participants received 6 g p.o. (3 g twice per day at 0800h and 2000h) of L-arginine 500mg capsules for 3 weeks in addition to their antipsychotic treatment as usual. After a 5 day washout period, they then received placebo capsules (matching L-arginine 500mg) 6g p.o. (3 g twice per day at 0800h and 2000h) for 3 weeks in addition to their antipsychotic treatment as usual.
516318|NCT00718510|O2|Outcome|Placebo|Participants who received Placebo 6 g (matching L-arginine 500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study.
516319|NCT00718510|O1|Outcome|L-arginine|Participants who received L-arginine 6 g (500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study
516320|NCT00718510|O2|Outcome|Placebo|Participants who received Placebo 6 g (matching L-arginine 500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study.
516321|NCT00718510|O1|Outcome|L-arginine|Participants who received L-arginine 6 g (500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study
516322|NCT00718510|O2|Outcome|Placebo|Participants who received Placebo 6 g (matching L-arginine 500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study.
516323|NCT00718510|O1|Outcome|L-arginine|Participants who received L-arginine 6 g (500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study
516324|NCT00718510|E2|Reported Event|Placebo|Participants who received Placebo 6 g (matching L-arginine 500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study.
516325|NCT00718510|E1|Reported Event|L-arginine|Participants who received L-arginine 6 g (500mg capsules) at 0800h and 2000h in either the first or last 3 weeks of the study
516326|NCT00718328|B3|Baseline|Total|Total of all reporting groups
516327|NCT00718328|B2|Baseline|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
516328|NCT00718328|B1|Baseline|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
516329|NCT00718328|P2|Participant Flow|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
516330|NCT00718328|P1|Participant Flow|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
516331|NCT00718328|O2|Outcome|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
516332|NCT00718328|O1|Outcome|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
516336|NCT00718315|B3|Baseline|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516337|NCT00718315|B2|Baseline|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516338|NCT00718315|B1|Baseline|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516339|NCT00718315|P3|Participant Flow|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516340|NCT00718315|P2|Participant Flow|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516341|NCT00718315|P1|Participant Flow|Fisiogel|Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516342|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516343|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516344|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516345|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516346|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516347|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516348|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516349|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516350|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516351|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516352|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516353|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516354|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516355|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516356|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516357|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516358|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516359|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516360|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516361|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516554|NCT00717522|B1|Baseline|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
516362|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516363|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516364|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516365|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516366|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516367|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516368|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516369|NCT00718315|E3|Reported Event|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
516370|NCT00718315|E2|Reported Event|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516371|NCT00718315|E1|Reported Event|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
516372|NCT00718302|B3|Baseline|Total|Total of all reporting groups
516373|NCT00718302|B2|Baseline|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
516374|NCT00718302|B1|Baseline|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws.
516375|NCT00718302|P2|Participant Flow|Lateral Plate|Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws
516376|NCT00718302|P1|Participant Flow|Antiglide Plate|Antiglide Plate: A plate is placed behind the broken ankle and secured with screws
516377|NCT00718302|O2|Outcome|Randomized Treatment; Lateral Plate|"Randomized treatment; lateral plate~Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws"
516378|NCT00718302|O1|Outcome|Randomized Treatment; Antiglide Plate|"Randomized treatment; antiglide plate~Antiglide Plate: A plate is placed behind the broken ankle and secured with screws"
516379|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
516380|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
516381|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
516382|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
516383|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
516384|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
516385|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
516386|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
516387|NCT00718302|E2|Reported Event|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
516388|NCT00718302|E1|Reported Event|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
516389|NCT00718237|B3|Baseline|Total|Total of all reporting groups
516390|NCT00718237|B2|Baseline|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
516391|NCT00718237|B1|Baseline|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
516392|NCT00718237|P2|Participant Flow|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
516393|NCT00718237|P1|Participant Flow|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
516394|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study
516395|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
516396|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
516397|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
516398|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
516399|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
516400|NCT00718237|E2|Reported Event|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
516401|NCT00718237|E1|Reported Event|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
516402|NCT00718120|B3|Baseline|Total|Total of all reporting groups
516403|NCT00718120|B2|Baseline|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516404|NCT00718120|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516405|NCT00718120|P2|Participant Flow|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516406|NCT00718120|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516407|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516408|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516409|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516410|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516411|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516412|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516413|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516414|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516415|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516416|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516417|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516418|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516419|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516420|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516421|NCT00718120|E2|Reported Event|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
516422|NCT00718120|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
516423|NCT00718094|B3|Baseline|Total|Total of all reporting groups
516424|NCT00718094|B2|Baseline|Placebo|"Oral Placebo~Placebo Oral Tablet: Oral tablet: placebo"
516425|NCT00718094|B1|Baseline|Polyphenon E Treatment|Polyphenon E®: Oral capsules
516426|NCT00718094|P2|Participant Flow|Placebo|Placebo Oral Tablet: Oral tablet: placebo
516427|NCT00718094|P1|Participant Flow|Polyphenon Treatment|Polyphenon E®: Oral capsules for 56 days
516428|NCT00718094|O2|Outcome|Placebo|Placebo Oral Tablet: Oral tablet: placebo
516429|NCT00718094|O1|Outcome|Polyphenon E Treatment|Polyphenon E®: Oral capsules
516430|NCT00718094|E2|Reported Event|Placebo|Placebo Oral Tablet: Oral tablet: placebo
516431|NCT00718094|E1|Reported Event|Polyphenon E Treatment|Polyphenon E®: Oral capsules
516432|NCT00718081|B4|Baseline|Total|Total of all reporting groups
516433|NCT00718081|B3|Baseline|Placebo NanoTab|
516434|NCT00718081|B2|Baseline|Sufentanil NanoTab 15 mcg|
516435|NCT00718081|B1|Baseline|Sufentanil NanoTab 10 mcg|
516436|NCT00718081|P3|Participant Flow|Placebo NanoTab|
516437|NCT00718081|P2|Participant Flow|Sufentanil NanoTab 15 mcg|
516438|NCT00718081|P1|Participant Flow|Sufentanil NanoTab 10 mcg|
516439|NCT00718081|O3|Outcome|Placebo NanoTab|
516440|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
516441|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
516442|NCT00718081|O3|Outcome|Placebo NanoTab|
516443|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
516444|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
516445|NCT00718081|E3|Reported Event|Placebo NanoTab|
516446|NCT00718081|E2|Reported Event|Sufentanil NanoTab 15 mcg|
516447|NCT00718081|E1|Reported Event|Sufentanil NanoTab 10 mcg|
516448|NCT00718042|B7|Baseline|Total|Total of all reporting groups
516449|NCT00718042|B6|Baseline|Chagas Extended Evaluation|All subject's blood tested by the investigational Chagas screening test.
516450|NCT00718042|B5|Baseline|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
516451|NCT00718042|B4|Baseline|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
516452|NCT00718042|B3|Baseline|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
516555|NCT00717522|P1|Participant Flow|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
516453|NCT00718042|B2|Baseline|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
516454|NCT00718042|B1|Baseline|ABBOTT PRISM Chagas Specificity|All subject's blood tested by the investigational Chagas screening test.
516455|NCT00718042|P6|Participant Flow|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
516456|NCT00718042|P5|Participant Flow|Chagas Extended Evaluation|US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens.
516457|NCT00718042|P4|Participant Flow|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
516458|NCT00718042|P3|Participant Flow|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
516459|NCT00718042|P2|Participant Flow|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
516460|NCT00718042|P1|Participant Flow|ABBOTT PRISM Chagas Specificity|All blood donor specimens tested by the investigational Chagas screening test in design validation phase.
516461|NCT00718042|O1|Outcome|Reactivity in Chagas Endemic Population|Specimen from Chagas endemic area in South or Central America (524) under separate specimen collection protocol were tested with investigational ESA Chagas.
516462|NCT00718042|O1|Outcome|ESA Chagas Non-US Serologically Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols.
516463|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South or Central America under separate specimen collection protocols were tested with investigational with ESA Chagas.
516464|NCT00718042|O1|Outcome|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
516465|NCT00718042|O1|Outcome|ESA Chagas US Donor Specimen Testing|A total of 58 PRISM Chagas repeatedly reactive US blood donor specimens tested with both ESA Chagas and RIPA.
516466|NCT00718042|O1|Outcome|PRISM Chagas Reactivity Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
516467|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay.
516468|NCT00718042|O1|Outcome|Reactivity T Cruzi Antibody Positive|Specimen positive for T cruzi antibody collected in South America (85) under separate specimen collection protocol and unidentified US blood donor specimens repeatedly reactive by T cruzi antibody licensed screening assay (202) were tested with investigational PRISM Chagas screening assay.
516469|NCT00718042|O1|Outcome|ABBOTT PRISM Chagas Specificity|Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
516470|NCT00718042|E1|Reported Event|Donor Follow-up Specimen Collection|Blood donors
516471|NCT00717977|B1|Baseline|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516472|NCT00717977|P1|Participant Flow|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516473|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516474|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516475|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516476|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516477|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516478|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516479|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516480|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516481|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516482|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516556|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
516483|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516484|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516485|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516486|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516487|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516488|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516489|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516490|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516491|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516492|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516493|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516494|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516495|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516496|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516497|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516498|NCT00717977|E1|Reported Event|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
516499|NCT00717912|B1|Baseline|All Participants|Each subject received the study products in different order according to the randomization list
516500|NCT00717912|P6|Participant Flow|Arm 6|Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup
516501|NCT00717912|P5|Participant Flow|Arm 5|Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup
516502|NCT00717912|P4|Participant Flow|Arm 4|Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup
516503|NCT00717912|P3|Participant Flow|Arm 3|Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup
516504|NCT00717912|P2|Participant Flow|Arm 2|Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup
516505|NCT00717912|P1|Participant Flow|Arm 1|Classical sugar syrup/ Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup
516506|NCT00717912|O3|Outcome|Classical Sweetener Syrup|The subjects consumed once this product
516507|NCT00717912|O2|Outcome|Experimental Sweetener Syrup|The subjects consumed three times this product
516508|NCT00717912|O1|Outcome|Classical Sugar Syrup|The subjects consumed three times this product
516509|NCT00717912|O3|Outcome|Classical Sweetener Syrup|The subjects consumed once this product
516510|NCT00717912|O2|Outcome|Experimental Sweetener Syrup|The subjects consumed three times this product
516511|NCT00717912|O1|Outcome|Classical Sugar Syrup|The subjects consumed three time this product
516512|NCT00717912|E3|Reported Event|Classical Sweetener Syrup|The subjects consumed once this product
516513|NCT00717912|E2|Reported Event|Experimental Sweetener Syrup|The subjects consumed three times this product
516514|NCT00717912|E1|Reported Event|Classical Sugar Syrup|The subjects consumed three times this product
516515|NCT00717886|B1|Baseline|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
516516|NCT00717886|P1|Participant Flow|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
530126|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
516517|NCT00717886|O1|Outcome|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
516518|NCT00717886|E1|Reported Event|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
516519|NCT00717873|B3|Baseline|Total|Total of all reporting groups
516520|NCT00717873|B2|Baseline|CPT Arm|Airway clearance provided by manual CPT
516521|NCT00717873|B1|Baseline|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
516522|NCT00717873|P2|Participant Flow|CPT Arm|Airway clearance provided by manual CPT
516523|NCT00717873|P1|Participant Flow|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
516524|NCT00717873|O2|Outcome|CPT Arm|Airway clearance provided by manual CPT
516525|NCT00717873|O1|Outcome|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
516526|NCT00717873|E2|Reported Event|CPT Arm|Airway clearance provided by manual CPT
516527|NCT00717873|E1|Reported Event|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
516528|NCT00717860|B3|Baseline|Total|Total of all reporting groups
516529|NCT00717860|B2|Baseline|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516530|NCT00717860|B1|Baseline|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516531|NCT00717860|P2|Participant Flow|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516532|NCT00717860|P1|Participant Flow|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516533|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516534|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516535|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516536|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516537|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516538|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516539|NCT00717860|E2|Reported Event|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516540|NCT00717860|E1|Reported Event|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
516541|NCT00717756|B1|Baseline|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
516542|NCT00717756|P1|Participant Flow|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
516543|NCT00717756|O1|Outcome|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
516544|NCT00717756|E1|Reported Event|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
516545|NCT00717574|B3|Baseline|Total|Total of all reporting groups
516546|NCT00717574|B2|Baseline|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516547|NCT00717574|B1|Baseline|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516548|NCT00717574|P2|Participant Flow|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516549|NCT00717574|P1|Participant Flow|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516550|NCT00717574|O2|Outcome|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516551|NCT00717574|O1|Outcome|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516552|NCT00717574|E2|Reported Event|Propofol Group|"Propofol based general anesthesia~Propofol group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516553|NCT00717574|E1|Reported Event|Sevoflurane Group|"Sevoflurane based general anesthesia~Sevoflurane group: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture."
516558|NCT00717522|E1|Reported Event|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
516559|NCT00717418|B5|Baseline|Total|Total of all reporting groups
516560|NCT00717418|B4|Baseline|Missing Treatment Information|
516561|NCT00717418|B3|Baseline|Combination Treatments|
516562|NCT00717418|B2|Baseline|Artificial Tears Alone|
516563|NCT00717418|B1|Baseline|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
516564|NCT00717418|P4|Participant Flow|Missing Treatment Information|
516565|NCT00717418|P3|Participant Flow|Combination Treatments|
516566|NCT00717418|P2|Participant Flow|Artificial Tears Alone|
516567|NCT00717418|P1|Participant Flow|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
516568|NCT00717418|O1|Outcome|All Patients|
516569|NCT00717418|O1|Outcome|All Patients|
516570|NCT00717418|E1|Reported Event|All Patients|
516571|NCT00717405|B1|Baseline|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516572|NCT00717405|P1|Participant Flow|Bevacizumab + Trastuzumab Chemotherapy|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 milligrams per kilogram (mg/kg) intravenous (IV) bevacizumab every 3 weeks (q3w) for 8 cycles, 4 cycles of 500 milligrams per squared-meter (mg/m^2) IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516573|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516574|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516575|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516576|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516596|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516893|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516577|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516578|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516579|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516580|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516581|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516582|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516583|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516584|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516637|NCT00717288|B1|Baseline|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
516585|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516586|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516587|NCT00717405|E1|Reported Event|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
516588|NCT00717366|B3|Baseline|Total|Total of all reporting groups
516589|NCT00717366|B2|Baseline|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516590|NCT00717366|B1|Baseline|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516591|NCT00717366|P2|Participant Flow|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516592|NCT00717366|P1|Participant Flow|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received methoxy polyethylene glycol-epoetin beta (MIRCERA) intravenous (IV) injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-Stimulating Agent (ESA) dose (4 * previous weekly epoetin dose [international units {IU}]/250 or 4 * previous weekly darbepoetin alfa dose [micrograms {mcg}]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516593|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516594|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516595|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516638|NCT00717288|P3|Participant Flow|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
516597|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516598|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516599|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516600|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516601|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516602|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516603|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516604|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516605|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516606|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516607|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516608|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516609|NCT00717366|O2|Outcome|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516610|NCT00717366|O1|Outcome|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516611|NCT00717366|E2|Reported Event|MIRCERA Group 2: High-Conversion-Factor Group|Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516612|NCT00717366|E1|Reported Event|MIRCERA Group 1: Intermediate-Conversion-Factor Group|Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/250 or 4 * previous weekly darbepoetin alfa dose [mcg]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.
516613|NCT00717314|B3|Baseline|Total|Total of all reporting groups
516614|NCT00717314|B2|Baseline|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516615|NCT00717314|B1|Baseline|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516616|NCT00717314|P2|Participant Flow|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516617|NCT00717314|P1|Participant Flow|Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)|Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516618|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516619|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516620|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516621|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516881|NCT00716976|P1|Participant Flow|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516622|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516623|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516624|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516625|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516626|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516627|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516628|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516629|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516630|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516631|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516632|NCT00717314|E2|Reported Event|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516633|NCT00717314|E1|Reported Event|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
516634|NCT00717288|B4|Baseline|Total|Total of all reporting groups
516635|NCT00717288|B3|Baseline|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
516636|NCT00717288|B2|Baseline|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
530127|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
516639|NCT00717288|P2|Participant Flow|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
516640|NCT00717288|P1|Participant Flow|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
516641|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects that reverted back to an insulin drip
516642|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects that reverted back to an insulin drip
516643|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects that reverted back to an insulin drip
516644|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects with a BG value <65 mg/dl
516645|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects with a BG value <65 mg/dl
516646|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects with a BG value <65 mg/dl
516647|NCT00717288|O3|Outcome|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
516648|NCT00717288|O2|Outcome|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
516649|NCT00717288|O1|Outcome|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
516650|NCT00717288|E3|Reported Event|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
516651|NCT00717288|E2|Reported Event|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
516652|NCT00717288|E1|Reported Event|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
516653|NCT00717275|B1|Baseline|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
516654|NCT00717275|P1|Participant Flow|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
516655|NCT00717275|O1|Outcome|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
516656|NCT00717275|E1|Reported Event|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
516657|NCT00717249|B3|Baseline|Total|Total of all reporting groups
516658|NCT00717249|B2|Baseline|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
516659|NCT00717249|B1|Baseline|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516660|NCT00717249|P2|Participant Flow|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516661|NCT00717249|P1|Participant Flow|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516662|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
516663|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516664|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
516665|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516666|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
516667|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516668|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
516669|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516670|NCT00717249|E2|Reported Event|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
516671|NCT00717249|E1|Reported Event|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
516672|NCT00717236|B3|Baseline|Total|Total of all reporting groups
516673|NCT00717236|B2|Baseline|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516674|NCT00717236|B1|Baseline|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516675|NCT00717236|P2|Participant Flow|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516676|NCT00717236|P1|Participant Flow|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516677|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516678|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516882|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
516679|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516680|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516681|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516682|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516683|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516684|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516685|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516686|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516687|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516688|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516689|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516690|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516691|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516692|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516693|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516694|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516695|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516696|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516697|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516698|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516699|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516700|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516701|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516702|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516703|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516883|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516704|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516705|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516706|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516707|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516708|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516709|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516710|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516711|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516712|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516713|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516714|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516715|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516716|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516717|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516718|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516719|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516720|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516721|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516722|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516723|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516724|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516725|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516726|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516727|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516728|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516729|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516730|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516731|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516732|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516733|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516734|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516735|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516736|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516737|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516738|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516739|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516740|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
516741|NCT00717236|E3|Reported Event|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516742|NCT00717236|E2|Reported Event|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available.
516743|NCT00717236|E1|Reported Event|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
516744|NCT00717197|B1|Baseline|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
516745|NCT00717197|P1|Participant Flow|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
516746|NCT00717197|O1|Outcome|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
516884|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
516885|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516747|NCT00717197|E1|Reported Event|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
516748|NCT00717093|B3|Baseline|Total|Total of all reporting groups
516749|NCT00717093|B2|Baseline|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516750|NCT00717093|B1|Baseline|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516751|NCT00717093|P2|Participant Flow|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516752|NCT00717093|P1|Participant Flow|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516753|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516754|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516755|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516756|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516757|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516758|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516759|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516760|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516761|NCT00717093|E2|Reported Event|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516762|NCT00717093|E1|Reported Event|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
516763|NCT00717067|B6|Baseline|Total|Total of all reporting groups
516764|NCT00717067|B5|Baseline|ESRD on Hemodialysis|Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance <30 mL/min)
516765|NCT00717067|B4|Baseline|Severe Renal Impairment|Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
516766|NCT00717067|B3|Baseline|Moderate Renal Impairment|Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
516767|NCT00717067|B2|Baseline|Mild Renal Impairment|Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
516768|NCT00717067|B1|Baseline|Healthy Subjects|Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min)
516769|NCT00717067|P5|Participant Flow|ESRD: Single Dose|(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.
516770|NCT00717067|P4|Participant Flow|Severe Renal Impairment|Maraviroc 300 mg single dose.
516771|NCT00717067|P3|Participant Flow|Moderate Renal Impairment|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516772|NCT00717067|P2|Participant Flow|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516773|NCT00717067|P1|Participant Flow|Healthy Subjects|(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516774|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516775|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516776|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516777|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516778|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516779|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516780|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516781|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516782|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516783|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516784|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516785|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516786|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516787|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516788|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516789|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516790|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516791|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516792|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516793|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516794|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516795|NCT00717067|O1|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis
516796|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516797|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516798|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516799|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516800|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516801|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516802|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516803|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516804|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516805|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516806|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516807|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516808|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516809|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516810|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516811|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516812|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516813|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516814|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516815|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516816|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516817|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516818|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516819|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516820|NCT00717067|O4|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516821|NCT00717067|O3|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516822|NCT00717067|O2|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516823|NCT00717067|O1|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516886|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
516824|NCT00717067|O6|Outcome|ESRD|(I) Maraviroc 300 mg single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516825|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516826|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516827|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516828|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516829|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516830|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516831|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516832|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516833|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516834|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516835|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516836|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516837|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516838|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516839|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516840|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516841|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516842|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
516843|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516844|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516845|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516846|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
516847|NCT00717067|E7|Reported Event|ESRD: Dosing Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
516848|NCT00717067|E6|Reported Event|ESRD: Dosing After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
516849|NCT00717067|E5|Reported Event|Severe Renal Impairment:|Maraviroc 300 mg single dose.
516850|NCT00717067|E4|Reported Event|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
516851|NCT00717067|E3|Reported Event|Moderate Renal Impairment|Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516852|NCT00717067|E2|Reported Event|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516853|NCT00717067|E1|Reported Event|Healthy Subjects|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
516854|NCT00717054|B3|Baseline|Total|Total of all reporting groups
516855|NCT00717054|B2|Baseline|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516856|NCT00717054|B1|Baseline|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516857|NCT00717054|P2|Participant Flow|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516887|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516888|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
516889|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516858|NCT00717054|P1|Participant Flow|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516859|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516860|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516861|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516862|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516863|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516864|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516865|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516866|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516867|NCT00717054|E2|Reported Event|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516868|NCT00717054|E1|Reported Event|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
516869|NCT00717041|B1|Baseline|Presenting to the ED|Patients who present to the ED
516870|NCT00717041|P1|Participant Flow|Presenting to the ED|Patients who present to the ED
516871|NCT00717041|O2|Outcome|Cognitively Impaired in the ED|Patients presenting to the ED who have cognitive impairment
516872|NCT00717041|O1|Outcome|Depressed in the ED|Patients who present to the ED who test positive for depression
516873|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
516874|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
516875|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
516876|NCT00717041|E1|Reported Event|Presenting to the ED|Patients who present to the ED
516877|NCT00716976|B3|Baseline|Total|Total of all reporting groups
516878|NCT00716976|B2|Baseline|Observation Arm|No sodium thiosulfate treatment.
516879|NCT00716976|B1|Baseline|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516880|NCT00716976|P2|Participant Flow|Observation Arm|No sodium thiosulfate treatment.
516894|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
516895|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516896|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
516897|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
516898|NCT00716976|E2|Reported Event|Observation Arm|
516899|NCT00716976|E1|Reported Event|STS Arm (Sodium Thiosulfate Treatment)|
516900|NCT00716963|B1|Baseline|Screening/Baseline Participants|
516901|NCT00716963|P6|Participant Flow|Placebo/Budesonide/Fluticasone|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
516902|NCT00716963|P5|Participant Flow|Placebo/Fluticasone/Budesonide|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
516903|NCT00716963|P4|Participant Flow|Budesonide/Placebo/Fluticasone|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
516904|NCT00716963|P3|Participant Flow|Budesonide/Fluticasone/Placebo|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
516905|NCT00716963|P2|Participant Flow|Fluticasone/Placebo/Budesonide|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
516906|NCT00716963|P1|Participant Flow|Fluticasone/Budesonide/Placebo|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
516907|NCT00716963|O3|Outcome|Placebo|
516908|NCT00716963|O2|Outcome|Budesonide 400mcg|
516909|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
516910|NCT00716963|O3|Outcome|Placebo|
516911|NCT00716963|O2|Outcome|Budesonide 400mcg|
516912|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
516913|NCT00716963|E3|Reported Event|Placebo|
516914|NCT00716963|E2|Reported Event|Budesonide 400mcg|
516915|NCT00716963|E1|Reported Event|Fluticasone Propionate (Flovent Diskus) 250 mcg|
516916|NCT00716859|B3|Baseline|Total|Total of all reporting groups
516917|NCT00716859|B2|Baseline|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516918|NCT00716859|B1|Baseline|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516919|NCT00716859|P2|Participant Flow|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516920|NCT00716859|P1|Participant Flow|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516921|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516922|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516923|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516924|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516925|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516926|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516927|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516928|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516929|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516930|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516931|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516932|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516933|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516934|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516935|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516936|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516937|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516938|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516939|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516940|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516941|NCT00716859|E2|Reported Event|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
516942|NCT00716859|E1|Reported Event|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
516943|NCT00716820|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516944|NCT00716820|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516945|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516946|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516947|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516948|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516949|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516950|NCT00716820|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
516951|NCT00716820|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
516952|NCT00716820|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
516953|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
516954|NCT00716820|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
516955|NCT00716820|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
516956|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
516957|NCT00716820|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
516958|NCT00716820|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
516959|NCT00716820|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
516960|NCT00716820|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
516961|NCT00716820|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
516962|NCT00716820|O3|Outcome|Unknown|Participants with unknown PDGFRα mutation status who received sunitinib malate according to Japanese package insert
516963|NCT00716820|O2|Outcome|PDGFRα Without Mutation|Participants without PDGFRα mutation who received sunitinib malate according to Japanese package insert
516964|NCT00716820|O1|Outcome|PDGFRα With Mutation|Participants with PDGFRα mutation who received sunitinib malate according to Japanese package insert
516965|NCT00716820|O3|Outcome|Unknown|Participants with unknown c-kit mutation status who received sunitinib malate according to Japanese package insert
516966|NCT00716820|O2|Outcome|c-Kit Without Mutation|Participants without c-kit mutation who received sunitinib malate according to Japanese package insert
516967|NCT00716820|O1|Outcome|c-Kit With Mutation|Participants with c-kit mutation who received sunitinib malate according to Japanese package insert
516968|NCT00716820|O3|Outcome|Unknown|Participants with unknown KIT expression status who received sunitinib malate according to Japanese package insert
517048|NCT00716456|O1|Outcome|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
516969|NCT00716820|O2|Outcome|KIT Negative|Participants with negative KIT expression who received sunitinib malate according to Japanese package insert
516970|NCT00716820|O1|Outcome|KIT Positive|Participants with positive KIT expression who received sunitinib malate according to Japanese package insert
516971|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516972|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516973|NCT00716820|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
516974|NCT00716807|B5|Baseline|Total|Total of all reporting groups
516975|NCT00716807|B4|Baseline|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516976|NCT00716807|B3|Baseline|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516977|NCT00716807|B2|Baseline|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516978|NCT00716807|B1|Baseline|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516979|NCT00716807|P4|Participant Flow|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516980|NCT00716807|P3|Participant Flow|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516981|NCT00716807|P2|Participant Flow|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516982|NCT00716807|P1|Participant Flow|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516983|NCT00716807|O4|Outcome|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516984|NCT00716807|O3|Outcome|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516985|NCT00716807|O2|Outcome|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516986|NCT00716807|O1|Outcome|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516987|NCT00716807|E4|Reported Event|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516988|NCT00716807|E3|Reported Event|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516989|NCT00716807|E2|Reported Event|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
516990|NCT00716807|E1|Reported Event|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
516991|NCT00716742|B4|Baseline|Total|Total of all reporting groups
516992|NCT00716742|B3|Baseline|Xalatan®|latanoprost 0.005%
516993|NCT00716742|B2|Baseline|Travatan®|travoprost 0.004%
516994|NCT00716742|B1|Baseline|Lumigan®|bimatoprost 0.03%
516995|NCT00716742|P3|Participant Flow|Xalatan®|latanoprost 0.005%
516996|NCT00716742|P2|Participant Flow|Travatan®|travoprost 0.004%
516997|NCT00716742|P1|Participant Flow|Lumigan®|bimatoprost 0.03%
516998|NCT00716742|O3|Outcome|Xalatan®|latanoprost 0.005%
516999|NCT00716742|O2|Outcome|Travatan®|travoprost 0.004%
517000|NCT00716742|O1|Outcome|Lumigan®|bimatoprost 0.03%
517001|NCT00716742|E3|Reported Event|Xalatan®|latanoprost 0.005%
517002|NCT00716742|E2|Reported Event|Travatan®|travoprost 0.004%
517003|NCT00716742|E1|Reported Event|Lumigan®|bimatoprost 0.03%
517004|NCT00716625|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517005|NCT00716625|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517006|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517049|NCT00716456|E3|Reported Event|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
531665|NCT00684307|P2|Participant Flow|300 mg od|AZD0837 300 mg od
517007|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517008|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517009|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517010|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517011|NCT00716625|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
517012|NCT00716625|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
517013|NCT00716625|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
517014|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
517015|NCT00716625|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
517016|NCT00716625|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
517017|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
517018|NCT00716625|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
517019|NCT00716625|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
517020|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
517021|NCT00716625|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
517022|NCT00716625|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
517023|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
517024|NCT00716625|O2|Outcome|Adult|Participants aged ˃=15 years who received sunitinib malate according to Japanese package insert
517025|NCT00716625|O1|Outcome|Pediatric|Participants aged ˂15 years who received sunitinib malate according to Japanese package insert
517026|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517027|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517028|NCT00716625|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
517029|NCT00716482|B1|Baseline|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
517030|NCT00716482|P1|Participant Flow|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
517031|NCT00716482|O1|Outcome|Overall (All Masses)|Benign and malignant lesions
517032|NCT00716482|O1|Outcome|Overall (All Masses)|614 benign and 144 malignant masses
517033|NCT00716482|O3|Outcome|Not Homogeneous|"The Elastography image of the lesion is inhomogeneous and has a mottled or patchy appearance throughout."
517034|NCT00716482|O2|Outcome|Reasonably Homogeneous|"The Elastography image of the lesion has a slightly patchy appearance. The image may consist of larger (2-5mm) sub-regions within the lesion boundary that are homogenous, or the color differences between adjacent areas within the lesion are small."
517035|NCT00716482|O1|Outcome|Very Homogeneous|The Elastography image of the lesion has a smooth and consistent color appearance throughout, or very subtle color differences relating to small changes on the color scale are observed.
517036|NCT00716482|O2|Outcome|Sensitivity|Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
517037|NCT00716482|O1|Outcome|Specificity|Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
517038|NCT00716482|E1|Reported Event|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
517039|NCT00716456|B4|Baseline|Total|Total of all reporting groups
517040|NCT00716456|B3|Baseline|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
517041|NCT00716456|B2|Baseline|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
517042|NCT00716456|B1|Baseline|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
517043|NCT00716456|P3|Participant Flow|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
517044|NCT00716456|P2|Participant Flow|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
517045|NCT00716456|P1|Participant Flow|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
517046|NCT00716456|O3|Outcome|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
517047|NCT00716456|O2|Outcome|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
517050|NCT00716456|E2|Reported Event|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
517051|NCT00716456|E1|Reported Event|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
517052|NCT00716443|B1|Baseline|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
517053|NCT00716443|P1|Participant Flow|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
517054|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517055|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517056|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517057|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517058|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517059|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517060|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517061|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517062|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517063|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517064|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517065|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517066|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517067|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517068|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517069|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517070|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517071|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517072|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517073|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517074|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517075|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517076|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517077|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517078|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517079|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517080|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517081|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517082|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
517083|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
517084|NCT00716443|E1|Reported Event|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
517085|NCT00716417|B11|Baseline|Total|Total of all reporting groups
517086|NCT00716417|B10|Baseline|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517087|NCT00716417|B9|Baseline|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517088|NCT00716417|B8|Baseline|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517089|NCT00716417|B7|Baseline|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517090|NCT00716417|B6|Baseline|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517091|NCT00716417|B5|Baseline|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517092|NCT00716417|B4|Baseline|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517093|NCT00716417|B3|Baseline|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517346|NCT00716092|E3|Reported Event|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517094|NCT00716417|B2|Baseline|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517095|NCT00716417|B1|Baseline|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517096|NCT00716417|P10|Participant Flow|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517097|NCT00716417|P9|Participant Flow|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517098|NCT00716417|P8|Participant Flow|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517099|NCT00716417|P7|Participant Flow|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517100|NCT00716417|P6|Participant Flow|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517101|NCT00716417|P5|Participant Flow|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517102|NCT00716417|P4|Participant Flow|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517103|NCT00716417|P3|Participant Flow|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517104|NCT00716417|P2|Participant Flow|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517105|NCT00716417|P1|Participant Flow|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517106|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517107|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517108|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517109|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517110|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517111|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517112|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517113|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517114|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517115|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517116|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517117|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517118|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517119|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517120|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517121|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517122|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517123|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517124|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517125|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517126|NCT00716417|O2|Outcome|5FU + Cis + Afatinib (Regimen B)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
517127|NCT00716417|O1|Outcome|Pac + Cis + Afatinib (Regimen A)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
517128|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517129|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517130|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517131|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517132|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517133|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517134|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517135|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517136|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517137|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517138|NCT00716417|E10|Reported Event|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517139|NCT00716417|E9|Reported Event|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517140|NCT00716417|E8|Reported Event|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517141|NCT00716417|E7|Reported Event|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517142|NCT00716417|E6|Reported Event|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517143|NCT00716417|E5|Reported Event|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517144|NCT00716417|E4|Reported Event|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517145|NCT00716417|E3|Reported Event|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517146|NCT00716417|E2|Reported Event|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517147|NCT00716417|E1|Reported Event|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
517148|NCT00716274|B4|Baseline|Total|Total of all reporting groups
517149|NCT00716274|B3|Baseline|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517150|NCT00716274|B2|Baseline|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517151|NCT00716274|B1|Baseline|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517152|NCT00716274|P6|Participant Flow|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study.
517153|NCT00716274|P5|Participant Flow|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517154|NCT00716274|P4|Participant Flow|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517155|NCT00716274|P3|Participant Flow|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517156|NCT00716274|P2|Participant Flow|Placebo|Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517157|NCT00716274|P1|Participant Flow|Atomoxetine|Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III).
517158|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517159|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517160|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517161|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517162|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517163|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517164|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517165|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517166|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517167|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517168|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517169|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
531666|NCT00684307|P1|Participant Flow|150 mg od|AZD0837 150 mg od
517170|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517171|NCT00716274|O1|Outcome|Healthy Participants|Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
517172|NCT00716274|O5|Outcome|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517173|NCT00716274|O4|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
517174|NCT00716274|O3|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517175|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517176|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517177|NCT00716274|O3|Outcome|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517178|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517179|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517180|NCT00716274|O3|Outcome|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517181|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517182|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517183|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517184|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517185|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517186|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
517187|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517188|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517189|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517190|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517191|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517192|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517193|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517194|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517295|NCT00716144|O4|Outcome|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517195|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517196|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517197|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517198|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517199|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517200|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517201|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517202|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517203|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517204|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517205|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517206|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517207|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517208|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517209|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517210|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517211|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517212|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517213|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517214|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517215|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517216|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517217|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517218|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517219|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517344|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517220|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517221|NCT00716274|O2|Outcome|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517222|NCT00716274|O1|Outcome|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517223|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517224|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517225|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517226|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517227|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517228|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517229|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517230|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517231|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517232|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517233|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517234|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517235|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517236|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517237|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517238|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517239|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517240|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517241|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517242|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517243|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517345|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
531667|NCT00684307|O5|Outcome|VKA INR 2-3|
517244|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517245|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517246|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517247|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517248|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517249|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517250|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
517251|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517252|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517253|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517254|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517255|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517256|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517257|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517258|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517259|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517260|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517261|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517262|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517263|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517264|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517265|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517266|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517267|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517268|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517269|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517270|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517271|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517272|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517273|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517274|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517275|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517276|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517277|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517278|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517279|NCT00716274|O2|Outcome|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517280|NCT00716274|O1|Outcome|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517281|NCT00716274|E5|Reported Event|PLA/ATX|These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517282|NCT00716274|E4|Reported Event|ATX/PLA|These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517283|NCT00716274|E3|Reported Event|ATX/ATX|These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
517284|NCT00716274|E2|Reported Event|Placebo|Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
517285|NCT00716274|E1|Reported Event|Atomoxetine|Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
517286|NCT00716144|B5|Baseline|Total|Total of all reporting groups
517287|NCT00716144|B4|Baseline|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517288|NCT00716144|B3|Baseline|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517289|NCT00716144|B2|Baseline|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517290|NCT00716144|B1|Baseline|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
517291|NCT00716144|P4|Participant Flow|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517292|NCT00716144|P3|Participant Flow|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517293|NCT00716144|P2|Participant Flow|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 milligram (mg) orally, one capsule daily each morning with a meal for the 12 week treatment period.
517294|NCT00716144|P1|Participant Flow|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
517347|NCT00716092|E2|Reported Event|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517296|NCT00716144|O3|Outcome|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517297|NCT00716144|O2|Outcome|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517298|NCT00716144|O1|Outcome|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
517299|NCT00716144|O4|Outcome|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517300|NCT00716144|O3|Outcome|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517301|NCT00716144|O2|Outcome|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517302|NCT00716144|O1|Outcome|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
517303|NCT00716144|O4|Outcome|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517304|NCT00716144|O3|Outcome|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517305|NCT00716144|O2|Outcome|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517306|NCT00716144|O1|Outcome|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
517307|NCT00716144|O4|Outcome|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517308|NCT00716144|O3|Outcome|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517309|NCT00716144|O2|Outcome|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517310|NCT00716144|O1|Outcome|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
517311|NCT00716144|E4|Reported Event|R115866 2.0 mg|Eligible participants received R115866 softgel capsule 2.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517312|NCT00716144|E3|Reported Event|R115866 1.0 mg|Eligible participants received R115866 softgel capsule 1.0 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517313|NCT00716144|E2|Reported Event|R115866 0.5 mg|Eligible participants received R115866 softgel capsule 0.5 mg orally, one capsule daily each morning with a meal for the 12 week treatment period.
517314|NCT00716144|E1|Reported Event|Placebo|Eligible participants received R115866 matching placebo capsule orally, one capsule daily each morning with a meal for the 12 week treatment period.
517315|NCT00716092|B4|Baseline|Total|Total of all reporting groups
517316|NCT00716092|B3|Baseline|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517317|NCT00716092|B2|Baseline|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517318|NCT00716092|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
517319|NCT00716092|P3|Participant Flow|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517320|NCT00716092|P2|Participant Flow|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517321|NCT00716092|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
517322|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517323|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517324|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
517325|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517326|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517327|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
517328|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517329|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517330|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
517331|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517332|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517333|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
517334|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517335|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517336|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
517337|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517338|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517339|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
517340|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517341|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
517342|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
517343|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
517348|NCT00716092|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
517349|NCT00716079|B3|Baseline|Total|Total of all reporting groups
517350|NCT00716079|B2|Baseline|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517351|NCT00716079|B1|Baseline|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517352|NCT00716079|P2|Participant Flow|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517353|NCT00716079|P1|Participant Flow|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517354|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517355|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517356|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517357|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517358|NCT00716079|E2|Reported Event|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517359|NCT00716079|E1|Reported Event|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
517360|NCT00715962|B3|Baseline|Total|Total of all reporting groups
517361|NCT00715962|B2|Baseline|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
517374|NCT00715949|P1|Participant Flow|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury participating in computerized neurocognitive testing
517375|NCT00715949|O1|Outcome|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
517376|NCT00715949|E1|Reported Event|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
517377|NCT00715910|B5|Baseline|Total|Total of all reporting groups
517437|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517362|NCT00715962|B1|Baseline|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
517363|NCT00715962|P2|Participant Flow|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
517364|NCT00715962|P1|Participant Flow|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
517365|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
517366|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
517367|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
517368|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
517369|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
517370|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus a behavioral intervention that encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
517371|NCT00715962|E2|Reported Event|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
517372|NCT00715962|E1|Reported Event|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
517373|NCT00715949|B1|Baseline|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
517518|NCT00715754|B1|Baseline|Infants|
517378|NCT00715910|B4|Baseline|Nimenrix naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517379|NCT00715910|B3|Baseline|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517380|NCT00715910|B2|Baseline|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517381|NCT00715910|B1|Baseline|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517382|NCT00715910|P6|Participant Flow|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517383|NCT00715910|P5|Participant Flow|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517384|NCT00715910|P4|Participant Flow|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517385|NCT00715910|P3|Participant Flow|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517386|NCT00715910|P2|Participant Flow|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517387|NCT00715910|P1|Participant Flow|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517388|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517389|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517390|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517391|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517392|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517393|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517394|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517395|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517396|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517397|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517398|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517399|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517400|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517401|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517435|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517436|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517402|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517403|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517404|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517405|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517406|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517407|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517408|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517409|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5
517410|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517411|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517412|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517413|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517414|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517415|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517416|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517417|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517418|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517419|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517420|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517421|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517422|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517423|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517424|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517425|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517426|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517427|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517428|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517429|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517430|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517431|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517432|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517433|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517434|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517438|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517439|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517440|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517441|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517442|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517443|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517444|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517445|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517446|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517447|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517448|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517449|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517450|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517451|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517452|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517453|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517454|NCT00715910|E6|Reported Event|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517455|NCT00715910|E5|Reported Event|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517456|NCT00715910|E4|Reported Event|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
517457|NCT00715910|E3|Reported Event|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517458|NCT00715910|E2|Reported Event|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
517459|NCT00715910|E1|Reported Event|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
517460|NCT00715884|B3|Baseline|Total|Total of all reporting groups
517461|NCT00715884|B2|Baseline|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517462|NCT00715884|B1|Baseline|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517463|NCT00715884|P2|Participant Flow|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517464|NCT00715884|P1|Participant Flow|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517465|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517466|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517467|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517468|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517469|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517470|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517471|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517472|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517473|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517474|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517475|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517476|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517477|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517478|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517479|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517480|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517481|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517482|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517483|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517484|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517485|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517486|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517487|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517488|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517489|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517490|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517491|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517492|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517493|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517494|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517495|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517496|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517497|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517498|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517499|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517500|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517501|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517502|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517503|NCT00715884|E2|Reported Event|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
517504|NCT00715884|E1|Reported Event|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
517505|NCT00715793|B1|Baseline|All Study Participants DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy, or, have progressed despite prior therapies, who were treated with DAC 0.15 mg/kg intravenously daily × 5 days/week for 2 weeks + TMZ orally 75 mg/m^2 qd for weeks 2–5 of a 6-week cycle).
517506|NCT00715793|P2|Participant Flow|DAC (Decitabine) 0.15 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.15 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2–5 of a 6-week cycle.
517507|NCT00715793|P1|Participant Flow|DAC (Decitabine) 0.075 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.075 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2–5 of a 6-week cycle.
517508|NCT00715793|O1|Outcome|DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with Intravenous DAC of 0.15 mg/kg daily for 5 days a week for the first 2 weeks of a 6-week cycle who received TMZ orally at 75 mg/m^2 daily for 4 weeks (weeks 2–5) of a 6-week cycle.
517509|NCT00715793|O1|Outcome|DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with Intravenous DAC of 0.15 mg/kg daily for 5 days a week for the first 2 weeks of a 6-week cycle who received TMZ orally at 75 mg/m^2 daily for 4 weeks (weeks 2–5) of a 6-week cycle.
517510|NCT00715793|O1|Outcome|DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with Intravenous DAC of 0.15 mg/kg daily for 5 days a week for the first 2 weeks of a 6-week cycle who received TMZ orally at 75 mg/m^2 daily for 4 weeks (weeks 2–5) of a 6-week cycle.
517511|NCT00715793|O1|Outcome|DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with Intravenous DAC of 0.15 mg/kg daily for 5 days a week for the first 2 weeks of a 6-week cycle who received TMZ orally at 75 mg/m^2 daily for 4 weeks (weeks 2–5) of a 6-week cycle.
517512|NCT00715793|O1|Outcome|DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with Intravenous DAC of 0.15 mg/kg daily for 5 days a week for the first 2 weeks of a 6-week cycle who received TMZ orally at 75 mg/m^2 daily for 4 weeks (weeks 2–5) of a 6-week cycle.
517513|NCT00715793|O1|Outcome|Single Arm|"Decitabine: In Part I patients will be treated on a standard 3+3 phase I dose-escalation design starting at 0.075 mg/kg until a decitabine dose level of 0.15 mg/kg is reached, or, in case unacceptable toxicities are observed, at the maximum tolerated dose (Phase II recommended dose). Decitabine will be administered at the specified dose level, intravenously, daily 5 days a week for the first 2 weeks of a 6-week cycle.~Temozolomide: Temozolomide is available in 25 mg and 100 mg tablets that will be administered orally; doses will be rounded to the nearest 25 mg. Temozolomide will be administered orally at 75 mg/m2 daily for 4 weeks starting on week 2 of a 6-week cycle.~biopsy: Fine needle aspirates (FNA) and/or core biopsies of tumor samples will be obtained from consenting patients with accessible, evaluable disease, on days 1, 8, 15, and 29 of the first cycle and when patients go off study. Biopsies are optional in Phase I and required for all consenting subjects in Phase II."
517514|NCT00715793|O1|Outcome|DAC (Decitabine) + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with Intravenous DAC of 0.15 mg/kg daily for 5 days a week for the first 2 weeks of a 6-week cycle who received TMZ orally at 75 mg/m^2 daily for 4 weeks (weeks 2–5) of a 6-week cycle.
517515|NCT00715793|O2|Outcome|Dose Level 2:DAC (Decitabine) 0.15 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.15 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2–5 of a 6-week cycle.
517516|NCT00715793|O1|Outcome|Dose Level 1:DAC (Decitabine) 0.075 mg/kg + TMZ (Temozolomide)|Patients with non-resectable stage IIIB/C or stage IV metastatic melanoma with either no prior therapy or have progressed despite prior therapies, who were treated with DAC 0.075 mg/kg intravenously daily × 5 days/week for 2 weeks, TMZ orally 75 mg/m^2 qd for weeks 2–5 of a 6-week cycle.
517517|NCT00715793|E1|Reported Event|DAC (Decitabine) + TMZ (Temozolomide)|Comprehensive listing of adverse events are presented in total (includes events from both Phase 1 and and Phase 2 of study).
517519|NCT00715754|P1|Participant Flow|All Infants|One group comprised all infants evaluated.
517520|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
517521|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
517522|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
517523|NCT00715754|E1|Reported Event|All Infants|One group comprised all infants evaluated.
517524|NCT00715741|B5|Baseline|Total|Total of all reporting groups
517525|NCT00715741|B4|Baseline|Fi02 0.9 Without PEEP|90% oxygen without PEEP
517526|NCT00715741|B3|Baseline|Fi02 0.9 With PEEP|90% oxygen plus PEEP
517527|NCT00715741|B2|Baseline|Fi02 0.3 Without PEEP|30% oxygen without PEEP
517528|NCT00715741|B1|Baseline|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
517529|NCT00715741|P4|Participant Flow|Fi02 0.9 Without PEEP|90% oxygen without PEEP
517530|NCT00715741|P3|Participant Flow|Fi02 0.9 With PEEP|90% oxygen plus PEEP
517531|NCT00715741|P2|Participant Flow|Fi02 0.3 Without PEEP|30% oxygen without PEEP
517532|NCT00715741|P1|Participant Flow|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
517533|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
517534|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
517535|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
517536|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
517537|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
517538|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
517539|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
517540|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
517541|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
517542|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
517543|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
517544|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
517545|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
517546|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
517547|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
517548|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
517549|NCT00715741|E4|Reported Event|Fi02 0.9 Without PEEP|90% oxygen without PEEP
517550|NCT00715741|E3|Reported Event|Fi02 0.9 With PEEP|90% oxygen plus PEEP
517551|NCT00715741|E2|Reported Event|Fi02 0.3 Without PEEP|30% oxygen without PEEP
517552|NCT00715741|E1|Reported Event|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
517553|NCT00715676|B4|Baseline|Total|Total of all reporting groups
517554|NCT00715676|B3|Baseline|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517555|NCT00715676|B2|Baseline|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517556|NCT00715676|B1|Baseline|Placebo|Placebo soft gel capsules, oral, once daily
517557|NCT00715676|P3|Participant Flow|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517558|NCT00715676|P2|Participant Flow|220 ng of Vitamin D Analog (DP001)|220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
517559|NCT00715676|P1|Participant Flow|Placebo|Placebo soft gel capsules, oral, once daily
517560|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517561|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517562|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
517563|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517564|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517565|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
517566|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517567|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517568|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
517569|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517570|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517571|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
517572|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517573|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517574|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
517575|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517576|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517577|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
517578|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517579|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517580|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
517581|NCT00715676|E3|Reported Event|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
517582|NCT00715676|E2|Reported Event|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
517583|NCT00715676|E1|Reported Event|Placebo|Placebo soft gel capsules, oral, once daily
517584|NCT00715650|B3|Baseline|Total|Total of all reporting groups
517585|NCT00715650|B2|Baseline|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
517586|NCT00715650|B1|Baseline|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
517587|NCT00715650|P2|Participant Flow|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
517588|NCT00715650|P1|Participant Flow|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
517589|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
517590|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
517591|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
517592|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
517593|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
517594|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
517595|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
517596|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
517597|NCT00715650|E2|Reported Event|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
517598|NCT00715650|E1|Reported Event|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
517599|NCT00715624|B3|Baseline|Total|Total of all reporting groups
517600|NCT00715624|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
517601|NCT00715624|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
517602|NCT00715624|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
517603|NCT00715624|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
517604|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517605|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517606|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517607|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517608|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517609|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517610|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517611|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517612|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517613|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517614|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517615|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517616|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517617|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517618|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517619|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517620|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517621|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517622|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517623|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517624|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517625|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517626|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
517627|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
517628|NCT00715624|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
517629|NCT00715624|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
517630|NCT00715559|B1|Baseline|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
517631|NCT00715559|P1|Participant Flow|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
517632|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
517633|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
517634|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
517635|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
517636|NCT00715559|E1|Reported Event|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
517637|NCT00715520|B4|Baseline|Total|Total of all reporting groups
517638|NCT00715520|B3|Baseline|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
517639|NCT00715520|B2|Baseline|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
517640|NCT00715520|B1|Baseline|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
517641|NCT00715520|P3|Participant Flow|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
517642|NCT00715520|P2|Participant Flow|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
517643|NCT00715520|P1|Participant Flow|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
517644|NCT00715520|O1|Outcome|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
517645|NCT00715520|O1|Outcome|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
517646|NCT00715520|O1|Outcome|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
517647|NCT00715520|O1|Outcome|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
517648|NCT00715520|O1|Outcome|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
517649|NCT00715520|O1|Outcome|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
517650|NCT00715520|O1|Outcome|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
517651|NCT00715520|O1|Outcome|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
517652|NCT00715520|E3|Reported Event|Aim 3|Female and male subjects who have experienced a cerebral ischemic infarction will receive study drugs and TMS to measure M1 excitability.
517653|NCT00715520|E2|Reported Event|Aim 2|Healthy adult female and male subjects received TMS prior to measuring wrist extension movements.
517654|NCT00715520|E1|Reported Event|Aim 1|Healthy adult female and male subjects received study drugs and TMS to measure M1 excitability.
517655|NCT00715403|B8|Baseline|Total|Total of all reporting groups
517656|NCT00715403|B7|Baseline|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517657|NCT00715403|B6|Baseline|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517658|NCT00715403|B5|Baseline|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517659|NCT00715403|B4|Baseline|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517660|NCT00715403|B3|Baseline|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517661|NCT00715403|B2|Baseline|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517662|NCT00715403|B1|Baseline|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517663|NCT00715403|P7|Participant Flow|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517664|NCT00715403|P6|Participant Flow|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517665|NCT00715403|P5|Participant Flow|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517666|NCT00715403|P4|Participant Flow|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517667|NCT00715403|P3|Participant Flow|100mg BID|Patients were treated with 100 mg Nintedanib twice daily (BID).
517668|NCT00715403|P2|Participant Flow|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517669|NCT00715403|P1|Participant Flow|50mg QD|Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.
517670|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517671|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517672|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517673|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517674|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517675|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517676|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517677|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517678|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517679|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517680|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517681|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517682|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517683|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517684|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517685|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517686|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517687|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517688|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
531668|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
517689|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517690|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517691|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517692|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517693|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517694|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517695|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517696|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517697|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517698|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517699|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517700|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517701|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517702|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517703|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517704|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517705|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517706|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517707|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517708|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517709|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517710|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517711|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517712|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517713|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517714|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517715|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517716|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517717|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517718|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517719|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517720|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517721|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517722|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517723|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517724|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517725|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517726|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517727|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517728|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517729|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517730|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517731|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517732|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517733|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517734|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517735|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517736|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517737|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517738|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517739|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517740|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517741|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517742|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517743|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517744|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517745|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517746|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517747|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517748|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517749|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517750|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517751|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517752|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517753|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517754|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517755|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517756|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517757|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517758|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517759|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517760|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517761|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517762|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517763|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517764|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517765|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517766|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517767|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517768|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517769|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517770|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517771|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517772|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517773|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517774|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517775|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517776|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517777|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517778|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517779|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517780|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517781|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517782|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517783|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517784|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517785|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517786|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517787|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517788|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517789|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517790|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517791|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517792|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517793|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517794|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517795|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517796|NCT00715403|E7|Reported Event|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
517797|NCT00715403|E6|Reported Event|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
517798|NCT00715403|E5|Reported Event|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
517799|NCT00715403|E4|Reported Event|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
517800|NCT00715403|E3|Reported Event|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
517801|NCT00715403|E2|Reported Event|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
517802|NCT00715403|E1|Reported Event|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
517803|NCT00715390|B1|Baseline|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
517804|NCT00715390|P1|Participant Flow|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
517805|NCT00715390|O1|Outcome|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
517806|NCT00715390|E1|Reported Event|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
517846|NCT00715104|P3|Participant Flow|Sipuleucel-T Without Randomization to Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
518096|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
517807|NCT00715299|B1|Baseline|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
517808|NCT00715299|P1|Participant Flow|Total Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
517809|NCT00715299|O1|Outcome|Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.~18 responded with a walking speed greater than 0.16 m/s, while 9 has a change < 0.16 m/s."
517810|NCT00715299|E1|Reported Event|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
517811|NCT00715208|B3|Baseline|Total|Total of all reporting groups
517812|NCT00715208|B2|Baseline|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517813|NCT00715208|B1|Baseline|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517814|NCT00715208|P2|Participant Flow|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517815|NCT00715208|P1|Participant Flow|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517816|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517817|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517818|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517819|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517820|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517821|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517822|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517823|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517824|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517825|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517826|NCT00715208|E2|Reported Event|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
517827|NCT00715208|E1|Reported Event|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
517828|NCT00715117|B3|Baseline|Total|Total of all reporting groups
517829|NCT00715117|B2|Baseline|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 16 weeks
517830|NCT00715117|B1|Baseline|A: Placebo Control Group|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug for the last 8 weeks
517831|NCT00715117|P2|Participant Flow|B: Naltrexone Then Naltrexone|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 weeks followed by the same treatment for an additional 8 weeks
517832|NCT00715117|P1|Participant Flow|A: Placebo Then Naltrexone|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug naltrexone for the last 8 weeks
517833|NCT00715117|O2|Outcome|Naltrexone|These subjects were treated with naltrexone at a dose 0.1 mg/kg not to exceed 4.5 mg po daily for either 8 or 16 weeks.
517834|NCT00715117|O1|Outcome|Placebo|These subjects received placebo for 8 weeks by mouth daily.
517835|NCT00715117|O2|Outcome|Week 16|Quality of life survey values in all subjects determined at week 16 after all 12 participants had received naltrexone for either 8 or 16 weeks.
517836|NCT00715117|O1|Outcome|Baseline|Quality of life values in all subjects at baseline before receiving placebo or naltrexone.
517837|NCT00715117|O3|Outcome|Naltrexone|Includes all Naltrexone treated participants 8 weeks of treatment.
517838|NCT00715117|O2|Outcome|Placebo|Patients were treated with a placebo (sugar pill)for 8 weeks.
517839|NCT00715117|O1|Outcome|All Participants Pretreament|All participants prior to receiving placebo or naltrexone at week 0
517840|NCT00715117|E2|Reported Event|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 or 16 weeks
517841|NCT00715117|E1|Reported Event|A: Placebo Control Group|Subjects will receive placebo for 8weeks
517842|NCT00715104|B4|Baseline|Total|Total of all reporting groups
517843|NCT00715104|B3|Baseline|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase(received no further sipuleucel-T treatment).
517844|NCT00715104|B2|Baseline|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
517845|NCT00715104|B1|Baseline|Sipuleucel-T With Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
517847|NCT00715104|P2|Participant Flow|Sipuleucel-T Without Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
517848|NCT00715104|P1|Participant Flow|Sipuleucel-T With Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
517849|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to no booster
517850|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
517851|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to no booster
517852|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
517853|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to no booster
517854|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
517855|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
517856|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
517857|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
517858|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
517859|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
517860|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
517861|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to no booster
517862|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
517863|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
517864|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
517865|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
517866|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
517867|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
517868|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
517869|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
517870|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
517871|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
517872|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
517873|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PAP at 12 Weeks post-RP
517874|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PAP at 6 Weeks post-RP
517875|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PAP at pre-RP visit
517876|NCT00715104|O1|Outcome|Baseline|ELISPOT for PAP at baseline
517877|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PA2024 at 12 Weeks post-RP
517878|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PA2024 at 6 Weeks post-RP
517879|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PA2024 at Pre-RP Visit
517880|NCT00715104|O1|Outcome|Baseline|ELISPOT for PA2024 at baseline
517881|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
517882|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
517883|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
517884|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
517885|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
517886|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
517887|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
517888|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
517889|NCT00715104|O4|Outcome|Post-RP Tumor Interface|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
517890|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
517891|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
517892|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
517893|NCT00715104|E3|Reported Event|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
517894|NCT00715104|E2|Reported Event|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
517895|NCT00715104|E1|Reported Event|Sipuleucel-T With Booster|Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.
517896|NCT00715078|B4|Baseline|Total|Total of all reporting groups
517897|NCT00715078|B3|Baseline|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517898|NCT00715078|B2|Baseline|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517899|NCT00715078|B1|Baseline|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517900|NCT00715078|P3|Participant Flow|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517901|NCT00715078|P2|Participant Flow|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517902|NCT00715078|P1|Participant Flow|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517903|NCT00715078|O3|Outcome|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517904|NCT00715078|O2|Outcome|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517905|NCT00715078|O1|Outcome|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
517906|NCT00715078|E3|Reported Event|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
517907|NCT00715078|E2|Reported Event|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
517908|NCT00715078|E1|Reported Event|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL
517909|NCT00715026|B1|Baseline|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
517910|NCT00715026|P1|Participant Flow|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
517911|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
517912|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
517913|NCT00715026|E1|Reported Event|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
517914|NCT00714948|B1|Baseline|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
517915|NCT00714948|P1|Participant Flow|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
517916|NCT00714948|O1|Outcome|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
517917|NCT00714948|E1|Reported Event|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
517918|NCT00714870|B3|Baseline|Total|Total of all reporting groups
517919|NCT00714870|B2|Baseline|Control Group|control group: this group will not attend the nutrition and exercise program
517920|NCT00714870|B1|Baseline|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
517921|NCT00714870|P2|Participant Flow|Control Group: Standard of Care at Pediatrician's Office|control group: this group will not attend the nutrition and exercise program
517960|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
517961|NCT00714688|E3|Reported Event|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
517962|NCT00714688|E2|Reported Event|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
517963|NCT00714688|E1|Reported Event|Placebo|2 tablets placebo once daily for 13 weeks
517922|NCT00714870|P1|Participant Flow|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
517923|NCT00714870|O2|Outcome|Control|Control group received the standard of care at pediatrician's office
517924|NCT00714870|O1|Outcome|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
517925|NCT00714870|E2|Reported Event|Control|
517926|NCT00714870|E1|Reported Event|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
517927|NCT00714792|B3|Baseline|Total|Total of all reporting groups
517928|NCT00714792|B2|Baseline|Control Subjects|Control subjects
517929|NCT00714792|B1|Baseline|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
517930|NCT00714792|P2|Participant Flow|Control Subjects|Control subjects
517931|NCT00714792|P1|Participant Flow|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
517932|NCT00714792|O2|Outcome|Control Subjects|
517933|NCT00714792|O1|Outcome|Overactive Bladder Subjects|
517934|NCT00714792|E2|Reported Event|Control Subjects|Control subjects
517935|NCT00714792|E1|Reported Event|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
517936|NCT00714714|B1|Baseline|Combined Arms|All subjects received treatment with both gels in a split-face model
517937|NCT00714714|P1|Participant Flow|Combined Arms|All subjects received treatment with both gels in a split-face model
517938|NCT00714714|O2|Outcome|Tretinoin|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
517939|NCT00714714|O1|Outcome|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
517940|NCT00714714|E2|Reported Event|Tretinion|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
517941|NCT00714714|E1|Reported Event|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
517942|NCT00714688|B4|Baseline|Total|Total of all reporting groups
517943|NCT00714688|B3|Baseline|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
517944|NCT00714688|B2|Baseline|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
517945|NCT00714688|B1|Baseline|Placebo|2 tablets placebo once daily for 13 weeks
517946|NCT00714688|P3|Participant Flow|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
517947|NCT00714688|P2|Participant Flow|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
517948|NCT00714688|P1|Participant Flow|Placebo|2 tablets placebo once daily for 13 weeks
517949|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
517950|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
517951|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
517952|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
517953|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
517954|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
517955|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
517956|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
517957|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
517958|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
517959|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
517965|NCT00714571|B6|Baseline|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
517966|NCT00714571|B5|Baseline|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
517967|NCT00714571|B4|Baseline|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
517968|NCT00714571|B3|Baseline|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
517969|NCT00714571|B2|Baseline|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
517970|NCT00714571|B1|Baseline|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
517971|NCT00714571|P6|Participant Flow|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
517972|NCT00714571|P5|Participant Flow|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
517973|NCT00714571|P4|Participant Flow|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
517974|NCT00714571|P3|Participant Flow|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
517975|NCT00714571|P2|Participant Flow|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
517976|NCT00714571|P1|Participant Flow|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
517977|NCT00714571|O6|Outcome|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
517978|NCT00714571|O5|Outcome|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
517979|NCT00714571|O4|Outcome|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
517980|NCT00714571|O3|Outcome|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
517981|NCT00714571|O2|Outcome|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
517982|NCT00714571|O1|Outcome|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
517983|NCT00714571|E6|Reported Event|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
517984|NCT00714571|E5|Reported Event|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
517985|NCT00714571|E4|Reported Event|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
517986|NCT00714571|E3|Reported Event|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
517987|NCT00714571|E2|Reported Event|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
517988|NCT00714571|E1|Reported Event|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
517989|NCT00714493|B1|Baseline|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
517990|NCT00714493|P1|Participant Flow|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
517991|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
517992|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
517993|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
517994|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
517995|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
517996|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
517997|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
517998|NCT00714493|E1|Reported Event|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
517999|NCT00714389|B1|Baseline|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
518000|NCT00714389|P1|Participant Flow|Spontaneous Uroflow Measurements|Spontaneous voids of volunteers working in the care facility will recorded by uroflowmetry.
518001|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
518002|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
518003|NCT00714389|E1|Reported Event|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
518004|NCT00714311|B3|Baseline|Total|Total of all reporting groups
518005|NCT00714311|B2|Baseline|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
518006|NCT00714311|B1|Baseline|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
518007|NCT00714311|P2|Participant Flow|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
518008|NCT00714311|P1|Participant Flow|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
518009|NCT00714311|O2|Outcome|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
518010|NCT00714311|O1|Outcome|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
518011|NCT00714311|E2|Reported Event|Treatment by Experienced Community Psychotherapists|"treatment by experienced community psychotherapists (ECP)~treatment by experienced community psychotherapists: Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned."
531669|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
518012|NCT00714311|E1|Reported Event|Transference-Focused Psychotherapy|"Transference-Focused Psychotherapy (TFP)~Transference-Focused Psychotherapy: Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week"
518013|NCT00714285|B5|Baseline|Total|Total of all reporting groups
518014|NCT00714285|B4|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518015|NCT00714285|B3|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518016|NCT00714285|B2|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518017|NCT00714285|B1|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518018|NCT00714285|P4|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518019|NCT00714285|P3|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518020|NCT00714285|P2|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518021|NCT00714285|P1|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518022|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518023|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518024|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518025|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518026|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518027|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518028|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518029|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518030|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518031|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518032|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518033|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518034|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518035|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518036|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518037|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518038|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518039|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518040|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518041|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518042|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518043|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518044|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518045|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518046|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518047|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518048|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518049|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518050|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518051|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518052|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518053|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518054|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518055|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518056|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518057|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518058|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518059|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518060|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518061|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518062|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518063|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
518064|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518065|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518066|NCT00714285|E4|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518095|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
518067|NCT00714285|E3|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518068|NCT00714285|E2|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518069|NCT00714285|E1|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
518070|NCT00714259|B1|Baseline|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518071|NCT00714259|P1|Participant Flow|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518072|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518073|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518074|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518075|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518076|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518077|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518078|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518079|NCT00714259|E1|Reported Event|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
518080|NCT00714233|B5|Baseline|Total|Total of all reporting groups
518081|NCT00714233|B4|Baseline|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
518082|NCT00714233|B3|Baseline|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
518083|NCT00714233|B2|Baseline|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
518084|NCT00714233|B1|Baseline|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
518085|NCT00714233|P4|Participant Flow|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
518086|NCT00714233|P3|Participant Flow|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
518087|NCT00714233|P2|Participant Flow|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
518088|NCT00714233|P1|Participant Flow|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
518089|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
518090|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
518091|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
518092|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
518093|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
518094|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
531670|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
518097|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
518098|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
518099|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
518100|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
518101|NCT00714233|O4|Outcome|Placebo to Metformin|Matched to metformin pill
518102|NCT00714233|O3|Outcome|Lifestle|Those assigned to a nutrition and exercise program
518103|NCT00714233|O2|Outcome|Oral Contraceptive|group assigned to oral contraceptive for 24 weeks
518104|NCT00714233|O1|Outcome|Metformin|Group assigned to metformin with free androgen index measured
518105|NCT00714233|O1|Outcome|Lifestyle Program|Subjects enrolled in a nutrition and exercise program
518106|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
518107|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
518108|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
518109|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
518110|NCT00714233|E4|Reported Event|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
518111|NCT00714233|E3|Reported Event|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
518112|NCT00714233|E2|Reported Event|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
518113|NCT00714233|E1|Reported Event|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
518114|NCT00714168|B3|Baseline|Total|Total of all reporting groups
518115|NCT00714168|B2|Baseline|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518116|NCT00714168|B1|Baseline|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518117|NCT00714168|P2|Participant Flow|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518118|NCT00714168|P1|Participant Flow|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518119|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518120|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518121|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518122|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518123|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518124|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518156|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518157|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518158|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518159|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
531671|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
518125|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518126|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518127|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518128|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518129|NCT00714168|E2|Reported Event|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
518130|NCT00714168|E1|Reported Event|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
518131|NCT00714051|B3|Baseline|Total|Total of all reporting groups
518132|NCT00714051|B2|Baseline|Control Group|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
518133|NCT00714051|B1|Baseline|Falls Prevention Training Group|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
518134|NCT00714051|P2|Participant Flow|Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
518135|NCT00714051|P1|Participant Flow|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
518136|NCT00714051|O2|Outcome|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
518137|NCT00714051|O1|Outcome|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
518138|NCT00714051|E2|Reported Event|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
518139|NCT00714051|E1|Reported Event|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
518140|NCT00713830|B3|Baseline|Total|Total of all reporting groups
518141|NCT00713830|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
518142|NCT00713830|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
518143|NCT00713830|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
518144|NCT00713830|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
518145|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518146|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518147|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518148|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518149|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518150|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518151|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518152|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518153|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518154|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518155|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
531672|NCT00684307|O5|Outcome|VKA INR 2-3|
518160|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518161|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518162|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518163|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518164|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518165|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518166|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518167|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518168|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518169|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518170|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518171|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518172|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518173|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518174|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518175|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
518176|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
518177|NCT00713830|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
518178|NCT00713830|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
518179|NCT00713817|B3|Baseline|Total|Total of all reporting groups
518180|NCT00713817|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518181|NCT00713817|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518182|NCT00713817|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518183|NCT00713817|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518184|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518185|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518186|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518187|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518188|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518189|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518190|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518191|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518192|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518193|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518194|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518195|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518196|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518197|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518198|NCT00713817|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
518199|NCT00713817|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
518200|NCT00713700|B1|Baseline|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
518201|NCT00713700|P1|Participant Flow|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
518202|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
518203|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
518204|NCT00713700|E1|Reported Event|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
518205|NCT00713661|B5|Baseline|Total|Total of all reporting groups
518206|NCT00713661|B4|Baseline|Group 4: Laparoscopic Surgery Middle/Upper|
518210|NCT00713661|P4|Participant Flow|Group 4: Laparoscopic Surgery Middle/Upper|Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge.
518211|NCT00713661|P3|Participant Flow|Group 3: Laparoscopic Surgery Lower|Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
518212|NCT00713661|P2|Participant Flow|Group 2: Open Surgery Middle/Upper|Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge.
518213|NCT00713661|P1|Participant Flow|Group 1: Open Surgery Lower|Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
518214|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
518215|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
518216|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
518217|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
518218|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
518219|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
518220|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
518221|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
518222|NCT00713661|E4|Reported Event|Group 4: Laparoscopic Surgery Middle/Upper|
518223|NCT00713661|E3|Reported Event|Group 3: Laparoscopic Surgery Lower|
518224|NCT00713661|E2|Reported Event|Group 2: Open Surgery Middle/Upper|
518225|NCT00713661|E1|Reported Event|Group 1: Open Surgery Lower|
518226|NCT00713648|B1|Baseline|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
518227|NCT00713648|P1|Participant Flow|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
518228|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
518229|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
518230|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
518231|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
518232|NCT00713648|E1|Reported Event|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
518233|NCT00713609|B7|Baseline|Total|Total of all reporting groups
518234|NCT00713609|B6|Baseline|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518235|NCT00713609|B5|Baseline|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518236|NCT00713609|B4|Baseline|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518237|NCT00713609|B3|Baseline|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518238|NCT00713609|B2|Baseline|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518239|NCT00713609|B1|Baseline|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face
518302|NCT00713544|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518303|NCT00713544|B5|Baseline|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518304|NCT00713544|B4|Baseline|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518240|NCT00713609|P6|Participant Flow|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518241|NCT00713609|P5|Participant Flow|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518242|NCT00713609|P4|Participant Flow|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518243|NCT00713609|P3|Participant Flow|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518244|NCT00713609|P2|Participant Flow|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518245|NCT00713609|P1|Participant Flow|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face
518246|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518247|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518248|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518249|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518250|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518251|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518252|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518253|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518254|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518255|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518256|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
531673|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
518257|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518258|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518259|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518260|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518261|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518262|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518263|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518264|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518265|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518266|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518267|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518268|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518269|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518270|NCT00713609|E6|Reported Event|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518271|NCT00713609|E5|Reported Event|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518272|NCT00713609|E4|Reported Event|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518273|NCT00713609|E3|Reported Event|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518305|NCT00713544|B3|Baseline|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518274|NCT00713609|E2|Reported Event|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518275|NCT00713609|E1|Reported Event|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
518276|NCT00713596|B4|Baseline|Total|Total of all reporting groups
518277|NCT00713596|B3|Baseline|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
518278|NCT00713596|B2|Baseline|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
518279|NCT00713596|B1|Baseline|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
518280|NCT00713596|P3|Participant Flow|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
518281|NCT00713596|P2|Participant Flow|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
518282|NCT00713596|P1|Participant Flow|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
518283|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
518284|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
518285|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
518286|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
518287|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
518288|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
518289|NCT00713596|E3|Reported Event|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
518290|NCT00713596|E2|Reported Event|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
518291|NCT00713596|E1|Reported Event|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
518292|NCT00713583|B3|Baseline|Total|Total of all reporting groups
518293|NCT00713583|B2|Baseline|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
518294|NCT00713583|B1|Baseline|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
518295|NCT00713583|P2|Participant Flow|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
518296|NCT00713583|P1|Participant Flow|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
518297|NCT00713583|O2|Outcome|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
518298|NCT00713583|O1|Outcome|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
518299|NCT00713583|E2|Reported Event|Placebo|Placebo, cognitive behavioral therapy (CBT), and contingency management (CM).
518300|NCT00713583|E1|Reported Event|Levodopa Pharmacotherapy|Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).
518301|NCT00713544|B7|Baseline|Total|Total of all reporting groups
518306|NCT00713544|B2|Baseline|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518307|NCT00713544|B1|Baseline|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518308|NCT00713544|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518309|NCT00713544|P5|Participant Flow|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518310|NCT00713544|P4|Participant Flow|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518311|NCT00713544|P3|Participant Flow|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518312|NCT00713544|P2|Participant Flow|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518313|NCT00713544|P1|Participant Flow|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518314|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518315|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518316|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518317|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518318|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518319|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518320|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518321|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518322|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518323|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518324|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518325|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518326|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518327|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518328|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518329|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518330|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518331|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518332|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518333|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518334|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518335|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518336|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518337|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518338|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518339|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518340|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518341|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518342|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518343|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518344|NCT00713544|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
518345|NCT00713544|E5|Reported Event|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
518346|NCT00713544|E4|Reported Event|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
518347|NCT00713544|E3|Reported Event|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
518348|NCT00713544|E2|Reported Event|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
518349|NCT00713544|E1|Reported Event|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
518350|NCT00713479|B1|Baseline|Total Sample|Includes only subjects who completed both components of the trial.
518351|NCT00713479|P2|Participant Flow|Varenicline, Then Placebo|Varenicline dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the placebo condition is started. Placebo is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
518352|NCT00713479|P1|Participant Flow|Placebo, Then Varenicline|Placebo drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the varenicline condition is started. Varenicline is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
518353|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518354|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518752|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518355|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518356|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518357|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518358|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518359|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
518360|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518361|NCT00713479|E2|Reported Event|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
518362|NCT00713479|E1|Reported Event|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
518363|NCT00713349|B1|Baseline|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
518364|NCT00713349|P1|Participant Flow|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
518365|NCT00713349|O2|Outcome|Placebo Control|White Petrolatum : each subject acting as their own control
518366|NCT00713349|O1|Outcome|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
518367|NCT00713349|E2|Reported Event|Placebo Control|White Petrolatum : each subject acting as their own control
518368|NCT00713349|E1|Reported Event|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
518369|NCT00713323|B1|Baseline|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518370|NCT00713323|P1|Participant Flow|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518371|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518372|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518373|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518374|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518375|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518376|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518377|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518378|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518379|NCT00713323|E1|Reported Event|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
518380|NCT00713310|B3|Baseline|Total|Total of all reporting groups
518381|NCT00713310|B2|Baseline|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
518753|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518382|NCT00713310|B1|Baseline|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
518383|NCT00713310|P2|Participant Flow|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
518384|NCT00713310|P1|Participant Flow|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
518385|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
518386|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
518387|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
518388|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
518389|NCT00713310|E2|Reported Event|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
518390|NCT00713310|E1|Reported Event|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
518391|NCT00713258|B3|Baseline|Total|Total of all reporting groups
518392|NCT00713258|B2|Baseline|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
518393|NCT00713258|B1|Baseline|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
518394|NCT00713258|P2|Participant Flow|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
518395|NCT00713258|P1|Participant Flow|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
518396|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
518397|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
518398|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
518399|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
518400|NCT00713258|E2|Reported Event|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
518401|NCT00713258|E1|Reported Event|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
518402|NCT00713219|B1|Baseline|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
518403|NCT00713219|P1|Participant Flow|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
518404|NCT00713219|O1|Outcome|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
518405|NCT00713219|E1|Reported Event|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
518406|NCT00713206|B3|Baseline|Total|Total of all reporting groups
518407|NCT00713206|B2|Baseline|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
518408|NCT00713206|B1|Baseline|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
518409|NCT00713206|P2|Participant Flow|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
518410|NCT00713206|P1|Participant Flow|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
518411|NCT00713206|O2|Outcome|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
518412|NCT00713206|O1|Outcome|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
518413|NCT00713206|E2|Reported Event|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
518414|NCT00713206|E1|Reported Event|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
518415|NCT00712985|B1|Baseline|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
518416|NCT00712985|P1|Participant Flow|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
518417|NCT00712985|O1|Outcome|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
518418|NCT00712985|E1|Reported Event|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
518419|NCT00712959|B3|Baseline|Total|Total of all reporting groups
518420|NCT00712959|B2|Baseline|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518421|NCT00712959|B1|Baseline|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518754|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518422|NCT00712959|P2|Participant Flow|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518423|NCT00712959|P1|Participant Flow|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
518424|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518425|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518426|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518427|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518428|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518429|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518430|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518431|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518432|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518433|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518434|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518435|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518436|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518437|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518438|NCT00712959|E2|Reported Event|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
518439|NCT00712959|E1|Reported Event|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
518440|NCT00712933|B1|Baseline|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518441|NCT00712933|P1|Participant Flow|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518442|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518443|NCT00712933|O4|Outcome|Participants With Baseline Daily Dose of >40 mg|Participants were receiving a daily dose of >40 mg of prednisone and other steroids at Baseline.
518444|NCT00712933|O3|Outcome|Participants With Baseline Daily Dose of >7.5 to <=40 mg|Participants were receiving a daily dose of >7.5 to <=40 mg of prednisone and other steroids at Baseline.
518445|NCT00712933|O2|Outcome|Participants With Baseline Daily Dose of >0 to <=7.5 mg|Participants were receiving a daily dose of >0 to <=7.5 mg of prednisone and other steroids at Baseline.
518446|NCT00712933|O1|Outcome|Participants With no Prednisone and Other Steroids at Baseline|Participants were not receiving prednisone and other steroids at Baseline.
518447|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518448|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518539|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518449|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518450|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518451|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518452|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518453|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518454|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518455|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518456|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518457|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518458|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518459|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518460|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518461|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518462|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518463|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518464|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518465|NCT00712933|O1|Outcome|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518466|NCT00712933|E1|Reported Event|Belimumab 10mg/kg IV|Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial.
518467|NCT00712920|B4|Baseline|Total|Total of all reporting groups
518468|NCT00712920|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518469|NCT00712920|B2|Baseline|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518470|NCT00712920|B1|Baseline|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518471|NCT00712920|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518472|NCT00712920|P2|Participant Flow|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518473|NCT00712920|P1|Participant Flow|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518474|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518475|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518476|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518477|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518478|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518479|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518480|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518481|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518482|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518483|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518484|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518485|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518486|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518487|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518488|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518489|NCT00712920|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518490|NCT00712920|E2|Reported Event|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518491|NCT00712920|E1|Reported Event|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
518492|NCT00712725|B9|Baseline|Total|Total of all reporting groups
518493|NCT00712725|B8|Baseline|MK3207 200 mg|"MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518494|NCT00712725|B7|Baseline|MK3207 100 mg|"MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518495|NCT00712725|B6|Baseline|MK3207 50 mg|"MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518755|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518496|NCT00712725|B5|Baseline|MK3207 20 mg|"MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518497|NCT00712725|B4|Baseline|MK3207 10 mg|"MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518498|NCT00712725|B3|Baseline|MK3207 5 mg|"MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518499|NCT00712725|B2|Baseline|MK3207 2.5 mg|"MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518500|NCT00712725|B1|Baseline|Placebo|"Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
518501|NCT00712725|P8|Participant Flow|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518502|NCT00712725|P7|Participant Flow|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518503|NCT00712725|P6|Participant Flow|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518504|NCT00712725|P5|Participant Flow|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518505|NCT00712725|P4|Participant Flow|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518506|NCT00712725|P3|Participant Flow|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518507|NCT00712725|P2|Participant Flow|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518508|NCT00712725|P1|Participant Flow|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518509|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518510|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518511|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518512|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518513|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518514|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518515|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518516|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518517|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518518|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518519|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518520|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518521|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518522|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518523|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518524|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518525|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518526|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518527|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518528|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518529|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518530|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518531|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518532|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518533|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518534|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518535|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518536|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518537|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518538|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518749|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518540|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518541|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518542|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518543|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518544|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518545|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518546|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518547|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518548|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518549|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518550|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518551|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518552|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518553|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518554|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518555|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518556|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518557|NCT00712725|E8|Reported Event|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518558|NCT00712725|E7|Reported Event|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518559|NCT00712725|E6|Reported Event|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518560|NCT00712725|E5|Reported Event|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518561|NCT00712725|E4|Reported Event|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518562|NCT00712725|E3|Reported Event|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518563|NCT00712725|E2|Reported Event|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
518564|NCT00712725|E1|Reported Event|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
518565|NCT00712673|B4|Baseline|Total|Total of all reporting groups
518566|NCT00712673|B3|Baseline|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
518567|NCT00712673|B2|Baseline|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
518568|NCT00712673|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518569|NCT00712673|P4|Participant Flow|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
518570|NCT00712673|P3|Participant Flow|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
518571|NCT00712673|P2|Participant Flow|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
518572|NCT00712673|P1|Participant Flow|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
518573|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518574|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518575|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518576|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518577|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518578|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518579|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518580|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518581|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518582|NCT00712673|O6|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of lixisenatide.
518583|NCT00712673|O5|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518584|NCT00712673|O4|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518585|NCT00712673|O3|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
518586|NCT00712673|O2|Outcome|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
518587|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
518588|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518589|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518590|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
518591|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518592|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518593|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518594|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518595|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518596|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518597|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518598|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518599|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518600|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518601|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518602|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518603|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518604|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518605|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518606|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518607|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518608|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518609|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518610|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518611|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518612|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518613|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518614|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518615|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518616|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518617|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518618|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518619|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518620|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
518621|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518622|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518623|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518624|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518625|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518626|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518627|NCT00712673|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation morning and evening regimen of lixisenatide.
518628|NCT00712673|E5|Reported Event|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
518629|NCT00712673|E4|Reported Event|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
518630|NCT00712673|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
518631|NCT00712673|E2|Reported Event|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
518632|NCT00712673|E1|Reported Event|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
518633|NCT00712543|B3|Baseline|Total|Total of all reporting groups
518634|NCT00712543|B2|Baseline|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
518635|NCT00712543|B1|Baseline|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
518750|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518636|NCT00712543|P2|Participant Flow|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
518637|NCT00712543|P1|Participant Flow|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
518638|NCT00712543|O2|Outcome|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
518639|NCT00712543|O1|Outcome|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
518640|NCT00712543|E2|Reported Event|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
518641|NCT00712543|E1|Reported Event|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
518642|NCT00712530|B4|Baseline|Total|Total of all reporting groups
518643|NCT00712530|B3|Baseline|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518644|NCT00712530|B2|Baseline|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518645|NCT00712530|B1|Baseline|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518646|NCT00712530|P3|Participant Flow|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518647|NCT00712530|P2|Participant Flow|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518648|NCT00712530|P1|Participant Flow|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518649|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518650|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518651|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518652|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518653|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518654|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518655|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518656|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518657|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518658|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518659|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518660|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518661|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518662|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518663|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518664|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518751|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
531674|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
518665|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518666|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518667|NCT00712530|E3|Reported Event|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
518668|NCT00712530|E2|Reported Event|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
518669|NCT00712530|E1|Reported Event|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
518670|NCT00712348|B1|Baseline|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
518671|NCT00712348|P1|Participant Flow|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
518672|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
518673|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
518674|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
518675|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
518676|NCT00712348|E1|Reported Event|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
518677|NCT00712335|B6|Baseline|Total|Total of all reporting groups
518678|NCT00712335|B5|Baseline|Normal Controls|Normal controls did not receive any treatment.
518679|NCT00712335|B4|Baseline|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518680|NCT00712335|B3|Baseline|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518681|NCT00712335|B2|Baseline|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518682|NCT00712335|B1|Baseline|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518683|NCT00712335|P5|Participant Flow|Normal Controls|Normal controls did not receive any treatment.
518684|NCT00712335|P4|Participant Flow|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518685|NCT00712335|P3|Participant Flow|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518686|NCT00712335|P2|Participant Flow|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518687|NCT00712335|P1|Participant Flow|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518688|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
518689|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518690|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518691|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518692|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518693|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
518694|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518695|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518696|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518697|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518698|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
518699|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518700|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518701|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518702|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518703|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
518704|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518705|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518706|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518707|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518708|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
518709|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518710|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518711|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518712|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518713|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
518714|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518715|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518716|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518717|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518718|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
518719|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518720|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518721|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518722|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518723|NCT00712335|E5|Reported Event|Normal Controls|Normal controls did not receive any treatment.
518724|NCT00712335|E4|Reported Event|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518725|NCT00712335|E3|Reported Event|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518726|NCT00712335|E2|Reported Event|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
518727|NCT00712335|E1|Reported Event|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
518728|NCT00712244|B5|Baseline|Total|Total of all reporting groups
518729|NCT00712244|B4|Baseline|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518730|NCT00712244|B3|Baseline|Healon5|Healon5 Ophthalmic Viscosurgical Device
518731|NCT00712244|B2|Baseline|DUOVISC|DUOVISC® Viscoelastic system
518732|NCT00712244|B1|Baseline|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518733|NCT00712244|P4|Participant Flow|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518734|NCT00712244|P3|Participant Flow|Healon5|Healon5 Ophthalmic Viscosurgical Device
518735|NCT00712244|P2|Participant Flow|DUOVISC|DUOVISC® Viscoelastic system
518736|NCT00712244|P1|Participant Flow|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518737|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518738|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518739|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518740|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518741|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518742|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518743|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518744|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518745|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518746|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518747|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518748|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518756|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518757|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518758|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518759|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518760|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518761|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518762|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518763|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518764|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518765|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518766|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518767|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518768|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518769|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518770|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
518771|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
518772|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518773|NCT00712244|E4|Reported Event|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
518774|NCT00712244|E3|Reported Event|Healon5|Healon5 Ophthalmic Viscosurgical Device
518775|NCT00712244|E2|Reported Event|DUOVISC|DUOVISC® Viscoelastic system
518776|NCT00712244|E1|Reported Event|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
518777|NCT00712179|B1|Baseline|Stroke Survivors|Cross-sectional study with a single group of stroke survivors
518778|NCT00712179|P1|Participant Flow|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
518779|NCT00712179|O1|Outcome|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
518780|NCT00712179|E1|Reported Event|Stroke Survivors|Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions.
518781|NCT00712166|B3|Baseline|Total|Total of all reporting groups
518782|NCT00712166|B2|Baseline|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518783|NCT00712166|B1|Baseline|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518784|NCT00712166|P2|Participant Flow|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518785|NCT00712166|P1|Participant Flow|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518786|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518787|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518788|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518789|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518790|NCT00712166|O2|Outcome|AZLI 75 mg TID|"AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 76"
518791|NCT00712166|O1|Outcome|Placebo TID|"Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 108"
518792|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518793|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518794|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518795|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518796|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
531675|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
518797|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518798|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518799|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518800|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518801|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518802|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518803|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518804|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518805|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518806|NCT00712166|E2|Reported Event|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
518807|NCT00712166|E1|Reported Event|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
518808|NCT00712075|B4|Baseline|Total|Total of all reporting groups
518809|NCT00712075|B3|Baseline|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
518810|NCT00712075|B2|Baseline|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
518811|NCT00712075|B1|Baseline|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
518812|NCT00712075|P3|Participant Flow|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
518813|NCT00712075|P2|Participant Flow|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
518814|NCT00712075|P1|Participant Flow|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
518815|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
518816|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
518817|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
518818|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
518819|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
518820|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
518821|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
518822|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
518823|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
518824|NCT00712075|E3|Reported Event|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
518825|NCT00712075|E2|Reported Event|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
518826|NCT00712075|E1|Reported Event|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
518827|NCT00712010|B1|Baseline|Entire Study Population|Includes groups randomized to receive 7 products in a randomized series
518861|NCT00711997|E2|Reported Event|BC-819 8 mg|2 mL of 4 mg/mL for a total of 8 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
518862|NCT00711997|E1|Reported Event|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
518863|NCT00711971|B4|Baseline|Total|Total of all reporting groups
518864|NCT00711971|B3|Baseline|Soy Oil Placebo|placebo: control arm
518828|NCT00712010|P1|Participant Flow|7 Proteins Were Tested Randomly|"Seven high-protein meal replacement (MR) were tested. These high-protein MR contained 29% total energy intake (TEI) of protein, 28% TEI lipids and 43% TEI glucides in 400mL meal, were iso-nitrogenous and differed in their protein quality. The proteins were:~intact whey protein~whey protein micelles~exhaustively hydrolyzed whey protein~intact casein protein~exhaustively hydrolyzed casein protein~total milk protein~exhaustively hydrolyzed milk protein The high-protein MR were a 430g liquid meal containing 30g of the tested protein."
518829|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518830|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518831|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518832|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518833|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518834|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518835|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518836|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518837|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518838|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518839|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518840|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518841|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518842|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518843|NCT00712010|E7|Reported Event|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518844|NCT00712010|E6|Reported Event|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518845|NCT00712010|E5|Reported Event|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518846|NCT00712010|E4|Reported Event|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518847|NCT00712010|E3|Reported Event|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518848|NCT00712010|E2|Reported Event|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518849|NCT00712010|E1|Reported Event|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
518850|NCT00711997|B3|Baseline|Total|Total of all reporting groups
518851|NCT00711997|B2|Baseline|BC-819 8 mg|
518852|NCT00711997|B1|Baseline|BC-819 4 mg|
518853|NCT00711997|P2|Participant Flow|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
518854|NCT00711997|P1|Participant Flow|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
518855|NCT00711997|O2|Outcome|BC-819 8 mg|2 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
518856|NCT00711997|O1|Outcome|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
518857|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
518858|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
518859|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
518860|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
518865|NCT00711971|B2|Baseline|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
518866|NCT00711971|B1|Baseline|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
518867|NCT00711971|P3|Participant Flow|Soy Oil Placebo|Soy oil placebo: control arm
518868|NCT00711971|P2|Participant Flow|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518869|NCT00711971|P1|Participant Flow|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518870|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
518871|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518872|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518873|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
518874|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518875|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518876|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
518877|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518878|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518879|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
518880|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518881|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518882|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
518883|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518884|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518885|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
518886|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518887|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518888|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
518889|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518890|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518891|NCT00711971|O3|Outcome|Soy Oil Placebo|"Soy oil~placebo: control arm"
518892|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
518893|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
518894|NCT00711971|O3|Outcome|Soy Oil Placebo|placebo: control arm
518895|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
518896|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
518897|NCT00711971|E3|Reported Event|Soy Oil Placebo|Soy oil placebo: control arm
518898|NCT00711971|E2|Reported Event|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
518899|NCT00711971|E1|Reported Event|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
518900|NCT00711958|B3|Baseline|Total|Total of all reporting groups
518901|NCT00711958|B2|Baseline|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
518902|NCT00711958|B1|Baseline|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
518903|NCT00711958|P2|Participant Flow|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
518904|NCT00711958|P1|Participant Flow|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
518905|NCT00711958|O2|Outcome|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
518976|NCT00711802|P7|Participant Flow|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
518906|NCT00711958|O1|Outcome|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
518907|NCT00711958|E2|Reported Event|ERYPO® Janssen-Cilag|"ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa"
518908|NCT00711958|E1|Reported Event|HX575 Epoetin Alfa Hexal AG|"HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.~HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin"
518909|NCT00711880|B3|Baseline|Total|Total of all reporting groups
518910|NCT00711880|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518911|NCT00711880|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518912|NCT00711880|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518913|NCT00711880|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518914|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518915|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518916|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518917|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518918|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518919|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518920|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518921|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518922|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518923|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518924|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518925|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518926|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518927|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518928|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518929|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518930|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518931|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518932|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518933|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518934|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518935|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518936|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518937|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518938|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
531676|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
518939|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518940|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518941|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518942|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518943|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518944|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518945|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518946|NCT00711880|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
518947|NCT00711880|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
518948|NCT00711867|B3|Baseline|Total|Total of all reporting groups
518949|NCT00711867|B2|Baseline|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
518950|NCT00711867|B1|Baseline|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
518951|NCT00711867|P2|Participant Flow|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
518952|NCT00711867|P1|Participant Flow|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
518953|NCT00711867|O2|Outcome|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
518954|NCT00711867|O1|Outcome|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
518955|NCT00711867|E2|Reported Event|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
518956|NCT00711867|E1|Reported Event|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
518957|NCT00711828|B1|Baseline|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
518958|NCT00711828|P1|Participant Flow|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
518959|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
518960|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
518961|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
518962|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
518963|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
518964|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
518965|NCT00711828|E1|Reported Event|Treatment|Dexamethasone 40 mg PO on days 1, 8, 15, 22
518966|NCT00711802|B9|Baseline|Total|Total of all reporting groups
518967|NCT00711802|B8|Baseline|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
518968|NCT00711802|B7|Baseline|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
518969|NCT00711802|B6|Baseline|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
518970|NCT00711802|B5|Baseline|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
518971|NCT00711802|B4|Baseline|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
518972|NCT00711802|B3|Baseline|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
518973|NCT00711802|B2|Baseline|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
518974|NCT00711802|B1|Baseline|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
518975|NCT00711802|P8|Participant Flow|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
518977|NCT00711802|P6|Participant Flow|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
518978|NCT00711802|P5|Participant Flow|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
518979|NCT00711802|P4|Participant Flow|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
518980|NCT00711802|P3|Participant Flow|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
518981|NCT00711802|P2|Participant Flow|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
518982|NCT00711802|P1|Participant Flow|Age Group 1: Daptomycin|"Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
518983|NCT00711802|O4|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
518984|NCT00711802|O3|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
518985|NCT00711802|O2|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
518986|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
518987|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
518988|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
518989|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
518990|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
518991|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
518992|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
518993|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
518994|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
518995|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
518996|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
518997|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
518998|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
518999|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
519000|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
519001|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
519002|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
519003|NCT00711802|E8|Reported Event|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
519004|NCT00711802|E7|Reported Event|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
519005|NCT00711802|E6|Reported Event|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
531677|NCT00684307|O5|Outcome|VKA INR 2-3|
519006|NCT00711802|E5|Reported Event|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
519007|NCT00711802|E4|Reported Event|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
519008|NCT00711802|E3|Reported Event|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
519009|NCT00711802|E2|Reported Event|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
519010|NCT00711802|E1|Reported Event|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
519011|NCT00711646|B3|Baseline|Total|Total of all reporting groups
519012|NCT00711646|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519013|NCT00711646|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519014|NCT00711646|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519015|NCT00711646|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519016|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519017|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519018|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519019|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519020|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519021|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519022|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519023|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519024|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519025|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519026|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519027|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519028|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519029|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519030|NCT00711646|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
519031|NCT00711646|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
519032|NCT00711594|B5|Baseline|Total|Total of all reporting groups
519033|NCT00711594|B4|Baseline|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519034|NCT00711594|B3|Baseline|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519035|NCT00711594|B2|Baseline|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519036|NCT00711594|B1|Baseline|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
519037|NCT00711594|P4|Participant Flow|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519038|NCT00711594|P3|Participant Flow|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519039|NCT00711594|P2|Participant Flow|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519040|NCT00711594|P1|Participant Flow|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
519041|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519042|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519043|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
519044|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519593|NCT00710866|P1|Participant Flow|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519045|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519046|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519047|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
519048|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519049|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519050|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
519051|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519052|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519053|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
519054|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519055|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519056|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519057|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519058|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519059|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519060|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519061|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
519062|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519063|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519064|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519065|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519066|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519067|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
519068|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519069|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519070|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519071|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
519072|NCT00711594|E4|Reported Event|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519073|NCT00711594|E3|Reported Event|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
519074|NCT00711594|E2|Reported Event|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
519075|NCT00711594|E1|Reported Event|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
519076|NCT00711555|B1|Baseline|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
519077|NCT00711555|P1|Participant Flow|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
519078|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
519079|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
519080|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
519081|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
519082|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
519083|NCT00711529|B3|Baseline|Total|Total of all reporting groups
519084|NCT00711529|B2|Baseline|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519085|NCT00711529|B1|Baseline|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519086|NCT00711529|P2|Participant Flow|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519087|NCT00711529|P1|Participant Flow|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519088|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519089|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519090|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519091|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519092|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519093|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519094|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519095|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519096|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519097|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519098|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519099|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519100|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519101|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519102|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519103|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519104|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519105|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519106|NCT00711529|E2|Reported Event|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
519107|NCT00711529|E1|Reported Event|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
519108|NCT00711516|B3|Baseline|Total|Total of all reporting groups
519109|NCT00711516|B2|Baseline|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
519110|NCT00711516|B1|Baseline|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
519111|NCT00711516|P2|Participant Flow|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
519112|NCT00711516|P1|Participant Flow|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
519113|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519114|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519115|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519116|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519117|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519118|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519119|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519239|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519120|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519121|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519122|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519123|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519124|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519125|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519126|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519127|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519128|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519129|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519130|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519131|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519132|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519133|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519134|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519135|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519136|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519137|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519138|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519139|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519240|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519594|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519140|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519141|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519142|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519143|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519144|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519145|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519146|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519147|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519148|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519149|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519150|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519151|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519152|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519153|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519154|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519155|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519156|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519157|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519158|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519159|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519241|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519244|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519160|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519161|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519162|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519163|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519164|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519165|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519166|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519167|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519168|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519169|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519170|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519171|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519172|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519173|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519174|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519175|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519176|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519177|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519178|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519179|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519242|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519595|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519180|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519181|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519182|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519183|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519184|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519185|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519186|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519187|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519188|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519189|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519190|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519191|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519192|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519193|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519194|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519195|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519196|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519197|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519198|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519199|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519243|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519596|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519200|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519201|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519202|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
519203|NCT00711516|E2|Reported Event|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
519204|NCT00711516|E1|Reported Event|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
519205|NCT00711490|B1|Baseline|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
519206|NCT00711490|P1|Participant Flow|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
519207|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
519208|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
519209|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
519210|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
519211|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
519212|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
519213|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
519214|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
519215|NCT00711490|E1|Reported Event|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
519216|NCT00711477|B3|Baseline|Total|Total of all reporting groups
519217|NCT00711477|B2|Baseline|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519218|NCT00711477|B1|Baseline|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519219|NCT00711477|P2|Participant Flow|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519220|NCT00711477|P1|Participant Flow|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519221|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519222|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519223|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519224|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519225|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519226|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519227|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519228|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519229|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519230|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519231|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519232|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519233|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519234|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519235|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519236|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519237|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519238|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519597|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519245|NCT00711477|E2|Reported Event|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519246|NCT00711477|E1|Reported Event|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
519247|NCT00711464|B1|Baseline|All Participants|modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose, and placebo, in random sequence.
519248|NCT00711464|P1|Participant Flow|All Participants|modafinil 100 milligrams oral dose, 200 milligrams oral dose, 400 milligrams oral dose, and placebo, in randomly sequenced dosing periods.
519249|NCT00711464|O4|Outcome|Placebo|"Single oral placebo capsule~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519250|NCT00711464|O3|Outcome|400 mg|"modafinil 400 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519251|NCT00711464|O2|Outcome|200 mg|"modafinil 200 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519252|NCT00711464|O1|Outcome|100 mg|"modafinil 100 milligrams oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519253|NCT00711464|O4|Outcome|Placebo|"Single oral placebo capsule~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519254|NCT00711464|O3|Outcome|400 mg|"modafinil 400 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519255|NCT00711464|O2|Outcome|200 mg|"modafinil 200 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519256|NCT00711464|O1|Outcome|100 mg|"modafinil 100 milligrams oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519257|NCT00711464|O4|Outcome|Placebo|"Single oral placebo capsule~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519258|NCT00711464|O3|Outcome|400 mg|"modafinil 400 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519259|NCT00711464|O2|Outcome|200 mg|"modafinil 200 mg oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519260|NCT00711464|O1|Outcome|100 mg|"modafinil 100 milligrams oral dose~modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose"
519261|NCT00711464|E4|Reported Event|Placebo|Single oral placebo capsule
519262|NCT00711464|E3|Reported Event|400 mg|modafinil 400 mg oral dose
519263|NCT00711464|E2|Reported Event|200 mg|modafinil 200 mg oral dose
519264|NCT00711464|E1|Reported Event|100 mg|modafinil 100 milligrams oral dose
519265|NCT00711425|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519266|NCT00711425|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519267|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519268|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519269|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519270|NCT00711425|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519271|NCT00711347|B3|Baseline|Total|Total of all reporting groups
519272|NCT00711347|B2|Baseline|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519273|NCT00711347|B1|Baseline|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519274|NCT00711347|P2|Participant Flow|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519275|NCT00711347|P1|Participant Flow|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519276|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519277|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519278|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519279|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519280|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519281|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519282|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519283|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519284|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519285|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519286|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519287|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519288|NCT00711347|E2|Reported Event|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
519289|NCT00711347|E1|Reported Event|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
519290|NCT00711191|B4|Baseline|Total|Total of all reporting groups
519291|NCT00711191|B3|Baseline|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519292|NCT00711191|B2|Baseline|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519333|NCT00711113|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
531678|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
519293|NCT00711191|B1|Baseline|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519294|NCT00711191|P3|Participant Flow|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519295|NCT00711191|P2|Participant Flow|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519296|NCT00711191|P1|Participant Flow|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519297|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|"Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.~Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.~Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles."
519298|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519299|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519300|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519301|NCT00711191|O1|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519302|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519303|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519304|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519305|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519334|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519306|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519307|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519308|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519309|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519310|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519311|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519312|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519313|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519314|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519315|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519316|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519317|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519318|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519319|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519335|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519320|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519321|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519322|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519323|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519324|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519325|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519326|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519327|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519328|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519329|NCT00711191|E3|Reported Event|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
519330|NCT00711191|E2|Reported Event|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
519331|NCT00711191|E1|Reported Event|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
519332|NCT00711113|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519336|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519337|NCT00711113|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
519338|NCT00711100|B1|Baseline|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
519339|NCT00711100|P1|Participant Flow|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
519340|NCT00711100|O4|Outcome|Ariva|Number of participants who preferred this product during abstinence phase
519341|NCT00711100|O3|Outcome|Stonewall|Number of participants who preferred this product during abstinence phase
519342|NCT00711100|O2|Outcome|Marlboro Snus|Number of participants who preferred this product during abstinence phase
519343|NCT00711100|O1|Outcome|Camel Snus|Number of participants who preferred this product during abstinence phase
519344|NCT00711100|O5|Outcome|General Snus|Number of partiicipants who sampled General Snus
519345|NCT00711100|O4|Outcome|Ariva|Number of participants who sampled Ariva
519346|NCT00711100|O3|Outcome|Stonewall|Number of participants who sampled Stonewall
519347|NCT00711100|O2|Outcome|Marlboro Snus|Number of participants who sampled Marlboro Snus
519348|NCT00711100|O1|Outcome|Camel Snus|Number of participants who sampled Camel Snus
519349|NCT00711100|E5|Reported Event|General Snus|Participants who sampled General Snus
519350|NCT00711100|E4|Reported Event|Ariva|Participants who sampled Ariva
519351|NCT00711100|E3|Reported Event|Stonewall|Participants who sampled Stonewall
519352|NCT00711100|E2|Reported Event|Marlboro Snus|Participants who sampled Marlboro Snus
519353|NCT00711100|E1|Reported Event|Camel Snus|Participant who sampled Camel Snus
519354|NCT00711087|B3|Baseline|Total|Total of all reporting groups
519355|NCT00711087|B2|Baseline|ARM 1|Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
519356|NCT00711087|B1|Baseline|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
519357|NCT00711087|P2|Participant Flow|ARM 1|Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90
519358|NCT00711087|P1|Participant Flow|ARM 2|Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
519359|NCT00711087|O2|Outcome|ARM 1|Subjects randomized to receive 100 units of BOTOX-A on Days 0 and 90
519360|NCT00711087|O1|Outcome|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
519361|NCT00711087|E2|Reported Event|ARM 1|"Receiving BOTOX-A~BOTOX-A: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90"
519362|NCT00711087|E1|Reported Event|ARM 2|"Receiving placebo (saline injections)~Saline injection: Group 2-sham saline injections on both Day 0 and Day 90."
519363|NCT00711022|B1|Baseline|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
519364|NCT00711022|P1|Participant Flow|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
519365|NCT00711022|O1|Outcome|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
519366|NCT00711022|E1|Reported Event|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
519367|NCT00711009|B3|Baseline|Total|Total of all reporting groups
519368|NCT00711009|B2|Baseline|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519369|NCT00711009|B1|Baseline|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519370|NCT00711009|P2|Participant Flow|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519371|NCT00711009|P1|Participant Flow|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519372|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519373|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519374|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519375|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519376|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519377|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519378|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519379|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519380|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519381|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519382|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519383|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519384|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519385|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519386|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519387|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
531679|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
519388|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519389|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519390|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519391|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519392|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519393|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519394|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519395|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519396|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519397|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519398|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519399|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519400|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519401|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519402|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519403|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519404|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519405|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519406|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519407|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519408|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519409|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519410|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519411|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519412|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519413|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519414|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519415|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519416|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519417|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519418|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519419|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519420|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519421|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519422|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519423|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519424|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519425|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519426|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519427|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519428|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519429|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519430|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519431|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519432|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519433|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519434|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519435|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519436|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519437|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519438|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519439|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519440|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519441|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519442|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519443|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519444|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519445|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519446|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519447|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519448|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519449|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519450|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519451|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519452|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519453|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519454|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519455|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519456|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519457|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519458|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519459|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519460|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519461|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519462|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519463|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519464|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519465|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519466|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519467|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519468|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519469|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519470|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519471|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519472|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519473|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519474|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519475|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519476|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519477|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519478|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519479|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519480|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519481|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519482|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519483|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519484|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519485|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519486|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519487|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519488|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519489|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519490|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519491|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519492|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519493|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519494|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519495|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519496|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519497|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519498|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519499|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519500|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519501|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519502|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519503|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519504|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519505|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519506|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519507|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519508|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519509|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519510|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519511|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519512|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519513|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519514|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519515|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519516|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519517|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519518|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519519|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519520|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519521|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519522|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519523|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519524|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519525|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519526|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519527|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519528|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519529|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519530|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519531|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519532|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519533|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519534|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519535|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519536|NCT00711009|E2|Reported Event|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
519537|NCT00711009|E1|Reported Event|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
519538|NCT00710996|B4|Baseline|Total|Total of all reporting groups
519539|NCT00710996|B3|Baseline|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
519540|NCT00710996|B2|Baseline|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
519541|NCT00710996|B1|Baseline|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
519542|NCT00710996|P3|Participant Flow|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
519543|NCT00710996|P2|Participant Flow|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
519544|NCT00710996|P1|Participant Flow|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
519545|NCT00710996|O3|Outcome|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
519546|NCT00710996|O2|Outcome|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
519547|NCT00710996|O1|Outcome|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
519548|NCT00710996|E3|Reported Event|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
519549|NCT00710996|E2|Reported Event|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
519550|NCT00710996|E1|Reported Event|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
519551|NCT00710970|B1|Baseline|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
519552|NCT00710970|P1|Participant Flow|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
519553|NCT00710970|O1|Outcome|Single Arm Receiving 20 mg Tamoxifen|
519554|NCT00710970|E1|Reported Event|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
519555|NCT00710944|B4|Baseline|Total|Total of all reporting groups
519556|NCT00710944|B3|Baseline|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
519557|NCT00710944|B2|Baseline|Healed Ridges|"Immediate loading of implants placed in healed ridges.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
519558|NCT00710944|B1|Baseline|Extraction Sockets|"Immediate loading of implants placed in extraction sockets.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
519559|NCT00710944|P3|Participant Flow|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
531680|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
519560|NCT00710944|P2|Participant Flow|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
519561|NCT00710944|P1|Participant Flow|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
519562|NCT00710944|O3|Outcome|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
519563|NCT00710944|O2|Outcome|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
519564|NCT00710944|O1|Outcome|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
519565|NCT00710944|E3|Reported Event|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
519566|NCT00710944|E2|Reported Event|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
519567|NCT00710944|E1|Reported Event|Extractions Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
519568|NCT00710931|B1|Baseline|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
519569|NCT00710931|P1|Participant Flow|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
519570|NCT00710931|O1|Outcome|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
519571|NCT00710931|E1|Reported Event|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
519572|NCT00710905|B1|Baseline|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
519573|NCT00710905|P1|Participant Flow|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
519574|NCT00710905|O1|Outcome|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
519575|NCT00710905|E1|Reported Event|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
519576|NCT00710879|B3|Baseline|Total|Total of all reporting groups
519577|NCT00710879|B2|Baseline|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
519578|NCT00710879|B1|Baseline|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
519579|NCT00710879|P2|Participant Flow|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
519580|NCT00710879|P1|Participant Flow|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
519581|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
519582|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
519583|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
519584|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
519585|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
519586|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
519587|NCT00710879|E2|Reported Event|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
519588|NCT00710879|E1|Reported Event|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
519589|NCT00710866|B3|Baseline|Total|Total of all reporting groups
519590|NCT00710866|B2|Baseline|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519591|NCT00710866|B1|Baseline|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519592|NCT00710866|P2|Participant Flow|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
531681|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
519598|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519599|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519600|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519601|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519602|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519603|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519604|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519605|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519606|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519607|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519608|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519609|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519610|NCT00710866|E2|Reported Event|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
519611|NCT00710866|E1|Reported Event|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
519612|NCT00710840|B3|Baseline|Total|Total of all reporting groups
519613|NCT00710840|B2|Baseline|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
519614|NCT00710840|B1|Baseline|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
519615|NCT00710840|P2|Participant Flow|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
519616|NCT00710840|P1|Participant Flow|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
519617|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
519618|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
519619|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
519620|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
519621|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
519622|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
519623|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
519624|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
519625|NCT00710840|E2|Reported Event|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
519626|NCT00710840|E1|Reported Event|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
519627|NCT00710814|B3|Baseline|Total|Total of all reporting groups
519628|NCT00710814|B2|Baseline|Placebo - Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
519629|NCT00710814|B1|Baseline|Leptin - Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
519630|NCT00710814|P2|Participant Flow|Placebo-Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
519631|NCT00710814|P1|Participant Flow|Leptin-Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
519632|NCT00710814|O2|Outcome|Placebo Intervention|"Participants in the Placebo-Leptin arm were randomized to receive placebo for the first 16 weeks, and participants in the Leptin-Placebo arm were randomized to receive placebo for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
519633|NCT00710814|O1|Outcome|Leptin Intervention|"Participants in the Leptin-Placebo arm were randomized to first receive Leptin for the first 16 weeks, and participants in the Placebo-Leptin arm were randomized to receive Leptin for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
519634|NCT00710814|E2|Reported Event|Placebo Intervention|"This group Placebo Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Placebo only."
519635|NCT00710814|E1|Reported Event|Leptin Intervention|"This group Leptin Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Leptin only."
519636|NCT00710762|B3|Baseline|Total|Total of all reporting groups
519637|NCT00710762|B2|Baseline|Placebo|Patients were treated with matching placebo twice daily
519638|NCT00710762|B1|Baseline|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519639|NCT00710762|P2|Participant Flow|Placebo|Patients were treated with matching placebo twice daily
519640|NCT00710762|P1|Participant Flow|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519641|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
519642|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519643|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
519644|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519645|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
519646|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519647|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
519648|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519649|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
519650|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519651|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
519652|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
519653|NCT00710762|E2|Reported Event|Placebo|Patients were treated with matching placebo twice daily.
519654|NCT00710762|E1|Reported Event|Nintedanib|Patients were treated with 250mg nintedanib twice daily.
519655|NCT00710749|B1|Baseline|Entire Study Population|Includes groups randomized to use the Disposable device first and the Digital device first.
519656|NCT00710749|P2|Participant Flow|Digital Device First, Then Disposable Device|12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period.
519657|NCT00710749|P1|Participant Flow|Disposable Device First, Then Digital Device|12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period.
519658|NCT00710749|O3|Outcome|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
519659|NCT00710749|O2|Outcome|Clinic|Voidings recorded with the clinic gold standard.
519660|NCT00710749|O1|Outcome|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
519661|NCT00710749|E3|Reported Event|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
519662|NCT00710749|E2|Reported Event|Clinic|Voidings recorded with the clinic gold standard.
519663|NCT00710749|E1|Reported Event|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
519664|NCT00710684|B4|Baseline|Total|Total of all reporting groups
519665|NCT00710684|B3|Baseline|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519666|NCT00710684|B2|Baseline|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519667|NCT00710684|B1|Baseline|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519668|NCT00710684|P3|Participant Flow|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519753|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
531682|NCT00684307|O5|Outcome|VKA INR 2-3|
519669|NCT00710684|P2|Participant Flow|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519670|NCT00710684|P1|Participant Flow|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519671|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519672|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519673|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519674|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519675|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519676|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519677|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519678|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519679|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519680|NCT00710684|O4|Outcome|Donepezil 15 mg|Participants received a stable dose of donepezil 15 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
519681|NCT00710684|O3|Outcome|Donepezil 10 mg|Participants received a stable dose of donepezil 10 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
519682|NCT00710684|O2|Outcome|Donepezil 7.5 mg|Participants received a stable dose of donepezil 7.5 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
519683|NCT00710684|O1|Outcome|Donepezil 5 mg|Participants received a stable dose of donepezil 5 mg at least for 6 months and a stable regimen for at least 2 months. The participants received SB742457 15 mg or 35 mg or placebo matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy.
519684|NCT00710684|O2|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519685|NCT00710684|O1|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519752|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519781|NCT00710554|B3|Baseline|Total|Total of all reporting groups
519686|NCT00710684|O2|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519687|NCT00710684|O1|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519688|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519689|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519690|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519691|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519692|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519693|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519694|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519695|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519696|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519697|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519698|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519699|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519700|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519701|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519702|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
521207|NCT00708071|O2|Outcome|Complete Resolution of Ecchymosis With SoC But Not FS VH S/D 4|
519703|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519704|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519705|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519706|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519707|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519708|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519709|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519710|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519711|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519712|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519713|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519714|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519715|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519716|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519717|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519718|NCT00710684|O3|Outcome|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519719|NCT00710684|O2|Outcome|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
521208|NCT00708071|O1|Outcome|Complete Resolution of Ecchymosis With FS VH S/D 4 But Not SoC|
519720|NCT00710684|O1|Outcome|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519721|NCT00710684|E3|Reported Event|Donepezil + SB-742457 35 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 35 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519722|NCT00710684|E2|Reported Event|Donepezil + SB-742457 15 mg|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received SB742457 15 mg orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519723|NCT00710684|E1|Reported Event|Donepezil + Placebo|Eligible participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) received placebo tablets matching with SB742457 orally once daily for a treatment period of 48 weeks as an adjunct treatment to stable donepezil therapy. At the end of 24 weeks treatment participants were asked to consent/assent to continue their randomized treatment for a further 24 weeks.
519724|NCT00710606|B3|Baseline|Total|Total of all reporting groups
519725|NCT00710606|B2|Baseline|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
519726|NCT00710606|B1|Baseline|Obese Subjects|Obese subjects (BMI 30-39.9)
519727|NCT00710606|P2|Participant Flow|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
519728|NCT00710606|P1|Participant Flow|Obese Subjects|Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
519729|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
519730|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
519731|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
519732|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
519733|NCT00710606|O2|Outcome|Obese|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
519734|NCT00710606|O1|Outcome|Normal Weight|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
519735|NCT00710606|E2|Reported Event|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
519736|NCT00710606|E1|Reported Event|Obese Subjects|Obese subjects (BMI 30-39.9)
519737|NCT00710593|B3|Baseline|Total|Total of all reporting groups
519738|NCT00710593|B2|Baseline|Group B|Participants who have been receiving highly active retroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519739|NCT00710593|B1|Baseline|Group A|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy(HAART) for at least the six months prior to study entry.
519740|NCT00710593|P2|Participant Flow|HAART|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519741|NCT00710593|P1|Participant Flow|ART/HAART NAIVE|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
519742|NCT00710593|O2|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects.
519743|NCT00710593|O1|Outcome|Telephone Response System (TRS)|Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
519744|NCT00710593|O2|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects. Participants were directed to call the clinical site staff or return to the clinic for evaluation if they were concerned about their signs or symptoms or if any symptoms appeared severe. Participants brought their VRC with them to all of their study visits. The completed cards were collected after all vaccine study visits were completed.
519745|NCT00710593|O1|Outcome|Telephone Response System (TRS)|Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
519746|NCT00710593|O2|Outcome|Higher NSSB|Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).
519747|NCT00710593|O1|Outcome|Lower NSSB|Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
519748|NCT00710593|O2|Outcome|Higher NSSB|Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).
519749|NCT00710593|O1|Outcome|Lower NSSB|Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
519750|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519751|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
531683|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
519754|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519755|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
519756|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519757|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
519758|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519759|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
519760|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519761|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
519762|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
519763|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
519764|NCT00710593|O2|Outcome|Group B|Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
519765|NCT00710593|O1|Outcome|Group A|Antiretroviral therapy (ART) naïve or if ART exposed, have not received highlight active antiretroviral (HAART) for at least the six months prior to study entry.
519766|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-18 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
519767|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-16 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
519768|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-11 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
519769|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
519770|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
519771|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
519772|NCT00710593|O1|Outcome|All Study Participants|The results are reported for all study participants in both Group A and Group B.
519773|NCT00710593|O1|Outcome|All Study Participants|All study participants who were administered vaccine doses #1, 2, and/or 3.
519774|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
519775|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
519776|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
519777|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
519778|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-6 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
519779|NCT00710593|E2|Reported Event|Group B: Has Been Receiving HAART for > 6 Months, With Two HIV|Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
519780|NCT00710593|E1|Reported Event|Group A: HAART naïve or, if HAART Exposed, Has Not Received HA|Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
519782|NCT00710554|B2|Baseline|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519783|NCT00710554|B1|Baseline|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519784|NCT00710554|P2|Participant Flow|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519785|NCT00710554|P1|Participant Flow|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519786|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519787|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519788|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519789|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519790|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519791|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519792|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519793|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519794|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519795|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519796|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519797|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519798|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519799|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519800|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519801|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519802|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519803|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519804|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519805|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519806|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519807|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519808|NCT00710554|E2|Reported Event|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
519809|NCT00710554|E1|Reported Event|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
519810|NCT00710424|B3|Baseline|Total|Total of all reporting groups
519811|NCT00710424|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519812|NCT00710424|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519813|NCT00710424|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519814|NCT00710424|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519815|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519816|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519817|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519818|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519819|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519820|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519821|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519822|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519823|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519824|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519825|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519826|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519827|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519828|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519829|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519830|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519831|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519832|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519833|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519834|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519835|NCT00710424|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
519836|NCT00710424|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
519837|NCT00710385|B1|Baseline|Challenge Doses|This study employs a within-subjects design, all participant experience all challenge doses.
519838|NCT00710385|P1|Participant Flow|Intravenous Challenge Doses|This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
519839|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
519840|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
519841|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
519842|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
519843|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
519844|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
519845|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
519846|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
519847|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
519848|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
519849|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
519850|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
519851|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
519852|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
519853|NCT00710385|E1|Reported Event|Combined for All Study Conditions|This study employed a within-subjects design, all participants experienced all study conditions.
519854|NCT00710203|B1|Baseline|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
519855|NCT00710203|P1|Participant Flow|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
519856|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
519857|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
519858|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
519859|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
531684|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
519860|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
519861|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
519862|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
519863|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
519864|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
519865|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
519866|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
519867|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
519868|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
519869|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
519870|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
519871|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
519872|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
519873|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
519874|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
519875|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
519876|NCT00710203|E4|Reported Event|No Treatment|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
519877|NCT00710203|E3|Reported Event|Electrodesiccation|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
519878|NCT00710203|E2|Reported Event|Curettage|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
519879|NCT00710203|E1|Reported Event|Pulsed Dye Laser|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
519880|NCT00710034|B3|Baseline|Total|Total of all reporting groups
519881|NCT00710034|B2|Baseline|Snus|"Oral tobacco~Oral tobacco: Snus"
519882|NCT00710034|B1|Baseline|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519883|NCT00710034|P2|Participant Flow|Snus|"Oral tobacco~Oral tobacco: Snus"
519884|NCT00710034|P1|Participant Flow|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519885|NCT00710034|O2|Outcome|Snus|"Oral tobacco~Oral tobacco: Snus"
519886|NCT00710034|O1|Outcome|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519887|NCT00710034|O2|Outcome|Snus|"Oral tobacco~Oral tobacco: Snus"
519888|NCT00710034|O1|Outcome|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519889|NCT00710034|O2|Outcome|Snus|"Oral tobacco~Oral tobacco: Snus"
519890|NCT00710034|O1|Outcome|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519891|NCT00710034|O2|Outcome|Snus|"Oral tobacco~Oral tobacco: Snus"
519892|NCT00710034|O1|Outcome|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519893|NCT00710034|O2|Outcome|Snus|"Oral tobacco~Oral tobacco: Snus"
519894|NCT00710034|O1|Outcome|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519895|NCT00710034|E2|Reported Event|Snus|"Oral tobacco~Oral tobacco: Snus"
519896|NCT00710034|E1|Reported Event|Nicotine Gum|"Nicotine replacement therapy~Nicotine Gum: 4 mg Nicotine gum"
519897|NCT00710021|B4|Baseline|Total|Total of all reporting groups
519898|NCT00710021|B3|Baseline|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519899|NCT00710021|B2|Baseline|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519900|NCT00710021|B1|Baseline|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519901|NCT00710021|P3|Participant Flow|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519902|NCT00710021|P2|Participant Flow|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519903|NCT00710021|P1|Participant Flow|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519904|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519905|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519906|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519907|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519908|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519909|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519910|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519911|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519912|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519913|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519914|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519915|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519916|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519917|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519918|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519919|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519920|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519921|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519922|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519923|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519924|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519925|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519926|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519927|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519928|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519929|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519930|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519931|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519932|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519933|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519934|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519935|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519936|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519937|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519938|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519939|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519940|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519941|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519942|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519943|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519944|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519945|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519946|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519947|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519948|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519949|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519950|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519951|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519952|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519953|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519954|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519955|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519956|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519957|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519958|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519959|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519960|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519961|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519962|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519963|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519964|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519965|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519966|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519967|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519968|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519969|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519970|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519971|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519972|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519973|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519974|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519975|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519976|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519977|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
521516|NCT00707655|E1|Reported Event|Zalutumumab 4 mg/kg|8 weekly infusions
519978|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519979|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519980|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519981|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519982|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519983|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519984|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519985|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519986|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519987|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519988|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519989|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519990|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519991|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519992|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519993|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519994|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519995|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
519996|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
519997|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
519998|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
519999|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
520000|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
520001|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
520002|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
520003|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
520004|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
520005|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
520006|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
520007|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
520008|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
520009|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
520010|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
520011|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
520012|NCT00710021|E3|Reported Event|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
520013|NCT00710021|E2|Reported Event|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
520014|NCT00710021|E1|Reported Event|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
520015|NCT00709956|B3|Baseline|Total|Total of all reporting groups
520016|NCT00709956|B2|Baseline|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
520017|NCT00709956|B1|Baseline|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
520018|NCT00709956|P2|Participant Flow|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
520019|NCT00709956|P1|Participant Flow|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
520020|NCT00709956|O2|Outcome|Borg Dyspnea Score After Iloprost (5 µg) Treatment|
520021|NCT00709956|O1|Outcome|Borg Dyspnea Score After Placebo Treatment|
520022|NCT00709956|O2|Outcome|6MWD After Iloprost (5 µg) Treatment|
520023|NCT00709956|O1|Outcome|6MWD After Placebo Treatment|
520024|NCT00709956|E2|Reported Event|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
520025|NCT00709956|E1|Reported Event|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
520026|NCT00709891|B1|Baseline|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
520027|NCT00709891|P1|Participant Flow|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
520028|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
520029|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
520030|NCT00709891|E1|Reported Event|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
520031|NCT00709878|B5|Baseline|Total|Total of all reporting groups
520032|NCT00709878|B4|Baseline|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
520033|NCT00709878|B3|Baseline|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
520034|NCT00709878|B2|Baseline|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
520035|NCT00709878|B1|Baseline|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
520036|NCT00709878|P4|Participant Flow|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
520037|NCT00709878|P3|Participant Flow|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
520038|NCT00709878|P2|Participant Flow|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
520039|NCT00709878|P1|Participant Flow|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
520040|NCT00709878|O4|Outcome|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
520041|NCT00709878|O3|Outcome|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
520042|NCT00709878|O2|Outcome|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
520043|NCT00709878|O1|Outcome|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
520044|NCT00709878|E4|Reported Event|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
520045|NCT00709878|E3|Reported Event|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
520046|NCT00709878|E2|Reported Event|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
520047|NCT00709878|E1|Reported Event|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
520048|NCT00709852|B1|Baseline|Entire Study Population|Includes participants who received either treatment
520049|NCT00709852|P2|Participant Flow|Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
520050|NCT00709852|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
520051|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520052|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520053|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520054|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520055|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520056|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520057|NCT00709852|O1|Outcome|Combined Gadobutrol vs. Combined Gadoteridol|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520058|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520059|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520060|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520061|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520062|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520063|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520064|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520065|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520066|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520067|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520068|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520069|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520070|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520071|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520072|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520073|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520074|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520075|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520076|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520077|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520078|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520079|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520080|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520081|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520082|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520083|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520084|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520085|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520086|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520087|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520088|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520089|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520090|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520091|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520092|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520093|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520094|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520095|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520096|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520097|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520098|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520099|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520100|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520101|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520102|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520103|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520104|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520105|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520106|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520107|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520108|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520109|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520110|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520111|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520112|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520113|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520114|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520115|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520116|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520117|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520118|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520119|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520120|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520121|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520122|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520123|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520124|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520125|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520126|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520127|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520128|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520129|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520130|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520131|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520132|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520133|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520134|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520135|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520136|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520137|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520138|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520139|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520140|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520141|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520142|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520143|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520144|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520145|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520146|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520147|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520148|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520149|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520150|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520151|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520152|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520153|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520154|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520155|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520156|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520157|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520158|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520159|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520160|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Gadobutrol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
520161|NCT00709852|O1|Outcome|Gadobutrol-enhanced Compared to Gadoteridol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
520162|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Unenhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Unenhanced MRI.
520163|NCT00709852|O1|Outcome|Unenhanced Compared to Gadoteridol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
520164|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous). Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Unenhanced MRI.
520165|NCT00709852|O1|Outcome|Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
520166|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520167|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520168|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520169|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
520170|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520171|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520172|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520173|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520174|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520175|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520176|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520177|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520178|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520179|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520180|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520181|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520182|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520183|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520184|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520185|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520186|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520187|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520188|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520189|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520190|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520191|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520192|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520193|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520194|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520195|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520196|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520197|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520198|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520199|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
520200|NCT00709852|E2|Reported Event|Gadoteridol (ProHance)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
520201|NCT00709852|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
520202|NCT00709826|B3|Baseline|Total|Total of all reporting groups
520203|NCT00709826|B2|Baseline|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
520204|NCT00709826|B1|Baseline|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
520205|NCT00709826|P2|Participant Flow|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
520206|NCT00709826|P1|Participant Flow|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
520207|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
520208|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
520209|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
520210|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
520211|NCT00709826|E2|Reported Event|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
520212|NCT00709826|E1|Reported Event|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
520213|NCT00709761|B1|Baseline|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520214|NCT00709761|P1|Participant Flow|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520215|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520216|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520217|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520218|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520219|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520220|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520221|NCT00709761|E1|Reported Event|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
520222|NCT00709735|B3|Baseline|Total|Total of all reporting groups
520247|NCT00709696|E1|Reported Event|Placebo Varenicline|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
520404|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520223|NCT00709735|B2|Baseline|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520224|NCT00709735|B1|Baseline|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520225|NCT00709735|P2|Participant Flow|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520226|NCT00709735|P1|Participant Flow|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520227|NCT00709735|O2|Outcome|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520228|NCT00709735|O1|Outcome|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520229|NCT00709735|O2|Outcome|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520230|NCT00709735|O1|Outcome|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520231|NCT00709735|E2|Reported Event|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520232|NCT00709735|E1|Reported Event|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
520233|NCT00709722|B1|Baseline|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
520234|NCT00709722|P1|Participant Flow|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
520235|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
520236|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
520237|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
520238|NCT00709722|E1|Reported Event|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
520239|NCT00709696|B3|Baseline|Total|Total of all reporting groups
520240|NCT00709696|B2|Baseline|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
520241|NCT00709696|B1|Baseline|Placebo Varenicline|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
520242|NCT00709696|P2|Participant Flow|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
520243|NCT00709696|P1|Participant Flow|Placebo|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
520244|NCT00709696|O2|Outcome|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
520245|NCT00709696|O1|Outcome|Placebo Varenicline|"Placebo Varenicline~Placebo: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
520246|NCT00709696|E2|Reported Event|Varenicline|"Varenicline~Varenicline: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.)."
521517|NCT00707577|B3|Baseline|Total|Total of all reporting groups
520248|NCT00709618|B1|Baseline|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520249|NCT00709618|P1|Participant Flow|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 milligrams per meters squared [mg/m^2]) intravenously (IV) once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520250|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520251|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520252|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520253|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520254|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520255|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520256|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520257|NCT00709618|E1|Reported Event|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
520258|NCT00709592|B3|Baseline|Total|Total of all reporting groups
520259|NCT00709592|B2|Baseline|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520260|NCT00709592|B1|Baseline|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520261|NCT00709592|P2|Participant Flow|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520262|NCT00709592|P1|Participant Flow|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520263|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520264|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520265|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520266|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520267|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520268|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520269|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520270|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520271|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520272|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520273|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520274|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520275|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520276|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520277|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520278|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520279|NCT00709592|E2|Reported Event|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
520280|NCT00709592|E1|Reported Event|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
520281|NCT00709319|B1|Baseline|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520282|NCT00709319|P1|Participant Flow|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520405|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520283|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520284|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520285|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520286|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520287|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520288|NCT00709319|E1|Reported Event|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
520289|NCT00709306|B5|Baseline|Total|Total of all reporting groups
520290|NCT00709306|B4|Baseline|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
520291|NCT00709306|B3|Baseline|UV-detect Photos|Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that “Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage.” Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average.
520292|NCT00709306|B2|Baseline|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
520293|NCT00709306|B1|Baseline|Educational Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
520294|NCT00709306|P4|Participant Flow|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
520295|NCT00709306|P3|Participant Flow|UV-detect Photos|Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that “Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage.” Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average.
520296|NCT00709306|P2|Participant Flow|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
520297|NCT00709306|P1|Participant Flow|Education Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
520374|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520298|NCT00709306|O4|Outcome|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
520299|NCT00709306|O3|Outcome|UV-detect Photos|Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that “Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage.” Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average.
520300|NCT00709306|O2|Outcome|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
520301|NCT00709306|O1|Outcome|Education Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
520302|NCT00709306|O4|Outcome|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
520303|NCT00709306|O3|Outcome|UV-detect Photos|Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that “Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage.” Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average.
520304|NCT00709306|O2|Outcome|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
520305|NCT00709306|O1|Outcome|Education Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
520306|NCT00709306|E4|Reported Event|UV-detect Photos and Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black & white and UV-filtered photos of their faces. These sessions took about 25 minutes.
520307|NCT00709306|E3|Reported Event|UV-detect Photos|Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that “Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage.” Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average.
520308|NCT00709306|E2|Reported Event|Motivational Interviewing|Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.
520309|NCT00709306|E1|Reported Event|Education Control|Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
520310|NCT00709228|B1|Baseline|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170)
520311|NCT00709228|P1|Participant Flow|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
520312|NCT00709228|O1|Outcome|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
520313|NCT00709228|E1|Reported Event|PegInton Plus Rebetol|
520314|NCT00709124|B3|Baseline|Total|Total of all reporting groups
520315|NCT00709124|B2|Baseline|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520316|NCT00709124|B1|Baseline|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
520317|NCT00709124|P2|Participant Flow|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520318|NCT00709124|P1|Participant Flow|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
520319|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520320|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520321|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520322|NCT00709124|O1|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
520323|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520324|NCT00709124|O1|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
520325|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520326|NCT00709124|O1|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
520327|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520328|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520329|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520330|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520331|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520332|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520333|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520334|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520335|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520336|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520337|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520338|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520339|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520340|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520341|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520342|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520343|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520344|NCT00709124|O1|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520345|NCT00709124|O2|Outcome|NMES|60 minute daily NMES sessions every day for the duration of subject's ICU stay. Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.
520346|NCT00709124|O1|Outcome|Sham|"60 minute sham sessions every day for the duration of subject's ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520347|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520348|NCT00709124|O1|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
520349|NCT00709124|E2|Reported Event|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
520350|NCT00709124|E1|Reported Event|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
520351|NCT00709111|B1|Baseline|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520352|NCT00709111|P1|Participant Flow|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520353|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520354|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520355|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520356|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520357|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520358|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520359|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520360|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520361|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520362|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520363|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520364|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520365|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520366|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520367|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520368|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520369|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520370|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520371|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520372|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520373|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520853|NCT00708227|O1|Outcome|Whites ADRB2:ARG16ARG|All participants who had received Advair for 2 weeks at Visit 3.
520375|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520376|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520377|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520378|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520379|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520380|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520381|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520382|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520383|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520384|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520385|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520386|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520387|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520388|NCT00709111|E1|Reported Event|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
520389|NCT00709098|B4|Baseline|Total|Total of all reporting groups
520390|NCT00709098|B3|Baseline|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520391|NCT00709098|B2|Baseline|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520392|NCT00709098|B1|Baseline|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
520393|NCT00709098|P3|Participant Flow|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520394|NCT00709098|P2|Participant Flow|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520395|NCT00709098|P1|Participant Flow|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
520396|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520397|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 6 disc
520398|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520399|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520400|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
520401|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520402|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520403|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
521265|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
520406|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
520407|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520408|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520409|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
520410|NCT00709098|E3|Reported Event|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520411|NCT00709098|E2|Reported Event|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
520412|NCT00709098|E1|Reported Event|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
520413|NCT00709059|B1|Baseline|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
520414|NCT00709059|P1|Participant Flow|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
520415|NCT00709059|O1|Outcome|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
520416|NCT00709059|E1|Reported Event|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
520417|NCT00708942|B6|Baseline|Total|Total of all reporting groups
520418|NCT00708942|B5|Baseline|Arm 5: Placebo Ointment, no Illumination|
520419|NCT00708942|B4|Baseline|Arm 4: HAL Ointment, LED Diode Illumination|
520420|NCT00708942|B3|Baseline|Arm 3: No Intervention|
520421|NCT00708942|B2|Baseline|Arm 2: Placebo Suppository, Laser Illumination|
520422|NCT00708942|B1|Baseline|Arm 1: HAL Suppository, Laser Illumination|
520423|NCT00708942|P5|Participant Flow|Arm 5: Placebo Ointment, no Illumination|
520424|NCT00708942|P4|Participant Flow|Arm 4: HAL Ointment, LED Diode Illumination|
520425|NCT00708942|P3|Participant Flow|Arm 3: No Intervention|
520426|NCT00708942|P2|Participant Flow|Arm 2: Placebo Suppository, Laser Illumination|
520427|NCT00708942|P1|Participant Flow|Arm 1: HAL Suppository, Laser Illumination|
520428|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
520429|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
520430|NCT00708942|O3|Outcome|Arm 3: No Intervention|
520431|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
520432|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
520433|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
520434|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
520435|NCT00708942|O3|Outcome|Arm 3: No Intervention|
520436|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
520437|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
520438|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
520439|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
520440|NCT00708942|O3|Outcome|Arm 3: No Intervention|
520441|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
520442|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
520443|NCT00708942|E5|Reported Event|Arm 5: Placebo Ointment, no Illumination|
520444|NCT00708942|E4|Reported Event|Arm 4: HAL Ointment, LED Diode Illumination|
520445|NCT00708942|E3|Reported Event|Arm 3: No Intervention|
520446|NCT00708942|E2|Reported Event|Arm 2: Placebo Suppository, Laser Illumination|
520447|NCT00708942|E1|Reported Event|Arm 1: HAL Suppository, Laser Illumination|
520448|NCT00708877|B1|Baseline|Transplant|All patients enrolled in study.
520449|NCT00708877|P1|Participant Flow|Transplant|All patients enrolled in study.
520450|NCT00708877|O1|Outcome|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
520451|NCT00708877|E1|Reported Event|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
520452|NCT00708851|B1|Baseline|NB-UVB Alone|"One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week~Opposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week"
520453|NCT00708851|P1|Participant Flow|NB-UVB and NB-UVB+LCD|"NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week~NB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week"
520454|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
520455|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
520456|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
520457|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
520458|NCT00708851|E2|Reported Event|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
520459|NCT00708851|E1|Reported Event|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
520460|NCT00708734|B1|Baseline|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 5 weeks"
521518|NCT00707577|B2|Baseline|Control|No maintenance program provided
520461|NCT00708734|P1|Participant Flow|Arm 1|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
520462|NCT00708734|O1|Outcome|Composite Measures of Gait and Balance|Measurement of gait and balance using standardized tools
520463|NCT00708734|E1|Reported Event|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
520464|NCT00708721|B1|Baseline|All Groups|
520465|NCT00708721|P4|Participant Flow|Not Evaluable|
520466|NCT00708721|P3|Participant Flow|Cohort 3: 1 mg/Day for 7 Days|1 mg/day for 7/28 days
520467|NCT00708721|P2|Participant Flow|Cohort 2: 1 mg/Day for 10 Days|1 mg/day for 10/28 days and for cycle 1 and then 1 mg/day for 7/28 days for cycle 2 onward
520468|NCT00708721|P1|Participant Flow|Cohort 1: 5 mg/Day for 10 Days|5 mg/day for 10 out of 28 days
520469|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
520470|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
520471|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
520472|NCT00708721|O1|Outcome|All Evaluable Patients|All evaluable patients. Eleven patients were enrolled, but only nine were evaluable.
520473|NCT00708721|O1|Outcome|All Evaluable Patients|Only nine of the eleven patients were evaluable for this outcome measure.
520474|NCT00708721|O1|Outcome|All Evaluable Patients|"All participants enrolled.~Clofarabine: Clofarabine is a rationally designed, second generation purine nucleoside analogue. Clofarabine was designed as a hybrid molecule to overcome the limitations and incorporate the best qualities of both fludarabine (F-ara-A) and cladribine (2-CdA, CdA) both of which are currently approved by various regulatory authorities for treatment of hematologic malignancies."
520475|NCT00708721|O4|Outcome|Not Evaluable|
520476|NCT00708721|O3|Outcome|Cohort 3: 1 mg/Day for 7 Days|
520477|NCT00708721|O2|Outcome|Cohort 2: 1 mg/Day for 10 Days|
520478|NCT00708721|O1|Outcome|Cohort 1: 10 mg/Day for 10 Days|
520479|NCT00708721|E1|Reported Event|All Groups|All patients who received study treatment.
520480|NCT00708708|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520481|NCT00708708|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520482|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520483|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520484|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520485|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520542|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
521066|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
520486|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520487|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520488|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520489|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520490|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520491|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520492|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520493|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520494|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520495|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520496|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520497|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
520543|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520498|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
520499|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
520500|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
520501|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
520502|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
520503|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520504|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520505|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520506|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520507|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520508|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520544|NCT00708682|E3|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96."
520509|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520510|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520511|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520512|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520513|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520514|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520515|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520516|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520517|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520518|NCT00708708|O3|Outcome|Remaining Participants|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
520519|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
520520|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
520521|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520522|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520523|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520524|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520525|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520526|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520527|NCT00708708|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
520528|NCT00708682|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520529|NCT00708682|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520530|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520531|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520532|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520533|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520534|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520535|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520536|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520537|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520538|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520539|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520540|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520541|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
520545|NCT00708682|E2|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
520546|NCT00708682|E1|Reported Event|Infant Series 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).~Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively."
520547|NCT00708643|B3|Baseline|Total|Total of all reporting groups
520548|NCT00708643|B2|Baseline|Narafilcon A|Silicone hydrogel daily disposable contact lens
520549|NCT00708643|B1|Baseline|Habitual Silicone Hydrogel|Habitual contact lens wear.
520550|NCT00708643|P2|Participant Flow|Narafilcon A|Silicone hydrogel daily disposable contact lens
520551|NCT00708643|P1|Participant Flow|Habitual Silicone Hydrogel|Habitual contact lens wear.
520552|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
520553|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
520554|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
520555|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
520556|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
520557|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
520558|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
520559|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
520560|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
520561|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
520562|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
520563|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
520564|NCT00708643|E2|Reported Event|Narafilcon A|Silicone hydrogel daily disposable contact lens
520565|NCT00708643|E1|Reported Event|Habitual Silicone Hydrogel|Habitual contact lens wear.
520566|NCT00708552|B5|Baseline|Total|Total of all reporting groups
520567|NCT00708552|B4|Baseline|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520568|NCT00708552|B3|Baseline|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520569|NCT00708552|B2|Baseline|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520570|NCT00708552|B1|Baseline|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520571|NCT00708552|P4|Participant Flow|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520572|NCT00708552|P3|Participant Flow|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520573|NCT00708552|P2|Participant Flow|SB-742457-15mg|Participants received one tablet of SB-742457-15 milligrams (mg) and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520574|NCT00708552|P1|Participant Flow|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520575|NCT00708552|O2|Outcome|Donepezil 10 mg|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520576|NCT00708552|O1|Outcome|Donepezil 5 mg|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520577|NCT00708552|O2|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520578|NCT00708552|O1|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520579|NCT00708552|O2|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520580|NCT00708552|O1|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520581|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520582|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520583|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520584|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520585|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520586|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520587|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520588|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520589|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520590|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520591|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520592|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520593|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520594|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520595|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520596|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520597|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520598|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520599|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520600|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520601|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520602|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520603|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520604|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520605|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520606|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520607|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520608|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520609|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
521067|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
520610|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520611|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520612|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520613|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520614|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520615|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520616|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520617|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520618|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520619|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520620|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520621|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520622|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520623|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520624|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520625|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520626|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520627|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520628|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520629|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520630|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520631|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520632|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520633|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520634|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520635|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520636|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520664|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520637|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520638|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520639|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520640|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520641|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520642|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520643|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520644|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520645|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520646|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520647|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520648|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520649|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520650|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520651|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520652|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520653|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520654|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520655|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520656|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520657|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520658|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520659|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520660|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520661|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520662|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520663|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520846|NCT00708227|O4|Outcome|African Americans ADRB2:GLY16GLY|Participants had discontinued Advair for 36 hours.
520665|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520666|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520667|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520668|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520669|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520670|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520671|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520672|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520673|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520674|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520675|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520676|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520677|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520678|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520679|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520680|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520681|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520682|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520683|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520684|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520685|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520686|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520687|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520688|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520689|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520690|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520691|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520847|NCT00708227|O3|Outcome|African Americans ADRB2:ARG16ARG|Participants had discontinued Advair for 36 hours.
520692|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520693|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520694|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520695|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520696|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520697|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520698|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520699|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520700|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520701|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520702|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520703|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520704|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520705|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520706|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520707|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520708|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520709|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520710|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520711|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520712|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520713|NCT00708552|O4|Outcome|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520714|NCT00708552|O3|Outcome|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520715|NCT00708552|O2|Outcome|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520716|NCT00708552|O1|Outcome|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520717|NCT00708552|E4|Reported Event|Donepezil|Participants received Donepezil capsule by one-step titration 5mg Donepezil once daily (Week 1 to Week 4) before up-titrating at Visit 4 (Week 4) to 10 mg once daily dose for the remaining 20 weeks of the treatment period (Week 4 to 24) along with matching placebo to SB-747457.
520718|NCT00708552|E3|Reported Event|SB-742457-35mg|Participants received one tablet of SB-742457-35 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520848|NCT00708227|O2|Outcome|Whites ADRB2:GLY16GLY|Participants had discontinued Advair for 36 hours.
520719|NCT00708552|E2|Reported Event|SB-742457-15mg|Participants received one tablet of SB-742457-15 mg and one capsule of matching placebo to Donepezil orally each evening just prior to going to bed in the two treatment period (Week 1 to 4 and Week 4 to 24).
520720|NCT00708552|E1|Reported Event|Placebo|Participants received one tablet of matching placebo to SB-742457 (Week 1 to 4) and one capsule of matching placebo orally each evening just prior to going to bed (Week 4 to 24).
520721|NCT00708526|B3|Baseline|Total|Total of all reporting groups
520722|NCT00708526|B2|Baseline|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
520723|NCT00708526|B1|Baseline|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
520724|NCT00708526|P2|Participant Flow|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
520725|NCT00708526|P1|Participant Flow|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
520726|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
520727|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
520728|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
520729|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
520730|NCT00708526|E2|Reported Event|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
520731|NCT00708526|E1|Reported Event|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
520732|NCT00708500|B4|Baseline|Total|Total of all reporting groups
520733|NCT00708500|B3|Baseline|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520734|NCT00708500|B2|Baseline|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
520735|NCT00708500|B1|Baseline|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520736|NCT00708500|P3|Participant Flow|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520737|NCT00708500|P2|Participant Flow|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
520738|NCT00708500|P1|Participant Flow|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520739|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520740|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
520741|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520742|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520849|NCT00708227|O1|Outcome|Whites ADRB2:ARG16ARG|Participants had discontinued Advair for 36 hours.
520743|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
520744|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520745|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520746|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
520747|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520748|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520749|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
520750|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520751|NCT00708500|E3|Reported Event|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520752|NCT00708500|E2|Reported Event|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
520753|NCT00708500|E1|Reported Event|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
520754|NCT00708461|B3|Baseline|Total|Total of all reporting groups
520755|NCT00708461|B2|Baseline|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
520756|NCT00708461|B1|Baseline|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
520757|NCT00708461|P2|Participant Flow|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
520758|NCT00708461|P1|Participant Flow|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
520759|NCT00708461|O2|Outcome|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
520760|NCT00708461|O1|Outcome|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
520761|NCT00708461|E2|Reported Event|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
520762|NCT00708461|E1|Reported Event|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
520763|NCT00708435|B3|Baseline|Total|Total of all reporting groups
520764|NCT00708435|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
520765|NCT00708435|B1|Baseline|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520766|NCT00708435|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.
520767|NCT00708435|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
520768|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
520769|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520770|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
520771|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520772|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
520773|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520774|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
520775|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520776|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
520777|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520778|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
520779|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520780|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
520781|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520782|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520783|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
520784|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520785|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
520786|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520787|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
520788|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520789|NCT00708435|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
520790|NCT00708435|E1|Reported Event|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
520791|NCT00708422|B3|Baseline|Total|Total of all reporting groups
520792|NCT00708422|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
520793|NCT00708422|B1|Baseline|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
520794|NCT00708422|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
520795|NCT00708422|P1|Participant Flow|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
520796|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
520797|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
520798|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
520799|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
520800|NCT00708422|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
520801|NCT00708422|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
520802|NCT00708305|B1|Baseline|Overall Study|All randomized participants
520803|NCT00708305|P4|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520804|NCT00708305|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520805|NCT00708305|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520806|NCT00708305|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520850|NCT00708227|O4|Outcome|African Americans ADRB2:GLY16GLY|All participants who had received Advair for 2 weeks at Visit 3.
521266|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
520807|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520808|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520809|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520810|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds
520811|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520812|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520813|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520814|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520815|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520816|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520817|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520818|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520819|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520820|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520821|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520822|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520823|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520824|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520825|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520826|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520827|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520851|NCT00708227|O3|Outcome|African Americans ADRB2:ARG16ARG|All participants who had received Advair for 2 weeks at Visit 3.
520852|NCT00708227|O2|Outcome|Whites ADRB2:GLY16GLY|All participants who had received Advair for 2 weeks at Visit 3.
520828|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520829|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520830|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520831|NCT00708305|O2|Outcome|NaF Toothpaste (1400 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520832|NCT00708305|O1|Outcome|NaF Toothpaste(1450 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520833|NCT00708305|E4|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520834|NCT00708305|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520835|NCT00708305|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520836|NCT00708305|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
520837|NCT00708227|B5|Baseline|Total|Total of all reporting groups
520838|NCT00708227|B4|Baseline|African Americans ADRB2:GLY16GLY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520839|NCT00708227|B3|Baseline|African Americans ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520840|NCT00708227|B2|Baseline|Whites ADRB2:GLY16GLY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520841|NCT00708227|B1|Baseline|Whites ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol or 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520842|NCT00708227|P4|Participant Flow|African Americans ADRB2:GLY16GlY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520843|NCT00708227|P3|Participant Flow|African Americans ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520844|NCT00708227|P2|Participant Flow|Whites ADRb2:GLY16GLY|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~Salmeterol: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520845|NCT00708227|P1|Participant Flow|Whites ADRB2:ARG16ARG|"All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.~fluticasone: Fluticasone propionate MDI(dose to be determined by patient's current treatment) for 2 weeks, followed by Advair(R)Diskus (same dose of fluticasone propionate) for 2 weeks; Ipratropium bromide MDI used for prn symptom relief"
520854|NCT00708227|O4|Outcome|African Americans ADRB2:GLY16GLY|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
520855|NCT00708227|O3|Outcome|African Americans ADRB2:ARG16ARG|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
520856|NCT00708227|O2|Outcome|Whites ADRB2:Gly16Gly|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
520857|NCT00708227|O1|Outcome|Whites ADRB2:ARG16ARG|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Flovent for 2 weeks at Visit 2.
520858|NCT00708227|O4|Outcome|African Americans ADRB2:GLY16GLY|Visit 4 log10 methacholine PC20 data in African Americans with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
520859|NCT00708227|O3|Outcome|African Americans ADRB2:ARG16ARG|Visit 4 log10 methacholine PC20 data in African Americans with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
520860|NCT00708227|O2|Outcome|Whites ADRB2:Gly16Gly|Visit 4 log10 methacholine PC20 data in Whites with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
520861|NCT00708227|O1|Outcome|Whites ADRB2:ARG16ARG|Visit 4 log10 methacholine PC20 data in Whites with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
520862|NCT00708227|O4|Outcome|African Americans ADRB2:GLY16GLY|Visit 3 log10 methacholine PC20 data in African Americans with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Advair.
520863|NCT00708227|O3|Outcome|African Americans ADRB2:ARG16ARG|Visit 3 log10 methacholine PC20 data in African Americans with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Advair.
520864|NCT00708227|O2|Outcome|Whites ADRB2:Gly16Gly|Visit 3 log10 methacholine PC20 data in Whites with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Advair.
520865|NCT00708227|O1|Outcome|Whites ADRB2:ARG16ARG|Visit 3 log10 methacholine PC20 data in Whites with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Advair.
520866|NCT00708227|O4|Outcome|African Americans ADRB2:GLY16GLY|Log10 methacholine PC20 data in African Americans with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
520867|NCT00708227|O3|Outcome|African Americans ADRB2:ARG16ARG|Log10 methacholine PC20 data in African Americans with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
520868|NCT00708227|O2|Outcome|Whites ADRB2:Gly16Gly|Log10 methacholine PC20 data in Whites with the ADRB2 GLY16GLY genotype after receiving 2 weeks of Flovent.
520869|NCT00708227|O1|Outcome|Whites ADRB2:ARG16ARG|Log10 methacholine PC20 data in Whites with the ADRB2 ARG16ARG genotype after receiving 2 weeks of Flovent.
520870|NCT00708227|E4|Reported Event|African American ADRB2:GLY16GLY|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
520871|NCT00708227|E3|Reported Event|African American ADRB2:ARG16ARG|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
520872|NCT00708227|E2|Reported Event|Whites ADRB2:GLY16GLY|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
520873|NCT00708227|E1|Reported Event|Whites ADRB2:ARG16ARG|All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose. All participants receive ipratropium bromide for symptom rescue therapy.
520874|NCT00708214|B4|Baseline|Total|Total of all reporting groups
520875|NCT00708214|B3|Baseline|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520876|NCT00708214|B2|Baseline|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520877|NCT00708214|B1|Baseline|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520878|NCT00708214|P3|Participant Flow|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520879|NCT00708214|P2|Participant Flow|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520880|NCT00708214|P1|Participant Flow|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520881|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520882|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520883|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520884|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520885|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5 mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520886|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520887|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520888|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520889|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520890|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520891|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520892|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520893|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520894|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520895|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520896|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520897|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520898|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520899|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520900|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520901|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520902|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520903|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520904|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520905|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520906|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520907|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520908|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520909|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520910|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520911|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520912|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520913|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520914|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520915|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520916|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520917|NCT00708214|E3|Reported Event|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520918|NCT00708214|E2|Reported Event|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520919|NCT00708214|E1|Reported Event|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
520920|NCT00708201|B3|Baseline|Total|Total of all reporting groups
520921|NCT00708201|B2|Baseline|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520922|NCT00708201|B1|Baseline|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520923|NCT00708201|P2|Participant Flow|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520924|NCT00708201|P1|Participant Flow|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520925|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520926|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520927|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520928|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520929|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520930|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520931|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520932|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520933|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520934|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520935|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520936|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520937|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520938|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520939|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520940|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520941|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520942|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
521024|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
520943|NCT00708201|E2|Reported Event|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
520944|NCT00708201|E1|Reported Event|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
520945|NCT00708175|B3|Baseline|Total|Total of all reporting groups
520946|NCT00708175|B2|Baseline|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520947|NCT00708175|B1|Baseline|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520948|NCT00708175|P2|Participant Flow|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520949|NCT00708175|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520950|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520951|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520952|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520953|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520954|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520955|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520956|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520957|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520958|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520959|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520960|NCT00708175|E2|Reported Event|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
520961|NCT00708175|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
520962|NCT00708162|B3|Baseline|Total|Total of all reporting groups
520963|NCT00708162|B2|Baseline|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520964|NCT00708162|B1|Baseline|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520965|NCT00708162|P2|Participant Flow|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520966|NCT00708162|P1|Participant Flow|Elvitegravir|Elvitegravir (EVG) 85 or 150 mg tablet once daily plus raltegravir (RAL) placebo plus background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520967|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520968|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520969|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520970|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520971|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520972|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520973|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520974|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
521068|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
520975|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520976|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520977|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520978|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520979|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520980|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520981|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520982|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520983|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520984|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520985|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520986|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520987|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520988|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520989|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520990|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520991|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520992|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520993|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520994|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520995|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520996|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520997|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
520998|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
521069|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
520999|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
521000|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
521001|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
521002|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
521003|NCT00708162|E3|Reported Event|All Elvitegravir|Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during both the Randomized Phase and Open-Label Phase, and those experienced by participants in the Raltegravir group following switch to EVG in the Open-Label Phase only.
521004|NCT00708162|E2|Reported Event|Raltegravir|"Adverse events in this reporting group are those experienced by participants in the Raltegravir group during the Randomized Phase~RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
521005|NCT00708162|E1|Reported Event|Elvitegravir|"Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during the Randomized Phase~EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
521006|NCT00708123|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
521007|NCT00708123|P5|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
521008|NCT00708123|P4|Participant Flow|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521009|NCT00708123|P3|Participant Flow|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521010|NCT00708123|P2|Participant Flow|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521011|NCT00708123|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521012|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
521013|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521014|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521015|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521016|NCT00708123|O1|Outcome|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521017|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
521018|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521019|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521020|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521021|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521022|NCT00708123|O3|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
521023|NCT00708123|O2|Outcome|NaF Toothpaste (1350 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521025|NCT00708123|E5|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
521026|NCT00708123|E4|Reported Event|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521027|NCT00708123|E3|Reported Event|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521028|NCT00708123|E2|Reported Event|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521029|NCT00708123|E1|Reported Event|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
521030|NCT00708110|B5|Baseline|Total|Total of all reporting groups
521031|NCT00708110|B4|Baseline|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521032|NCT00708110|B3|Baseline|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521033|NCT00708110|B2|Baseline|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521034|NCT00708110|B1|Baseline|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521035|NCT00708110|P4|Participant Flow|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521036|NCT00708110|P3|Participant Flow|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521037|NCT00708110|P2|Participant Flow|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521038|NCT00708110|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521039|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521040|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521041|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521042|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521043|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521044|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521045|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521046|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521047|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521048|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521049|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521050|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521051|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521052|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521053|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521054|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521055|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521056|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521057|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521058|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521059|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521060|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521061|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521062|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521063|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521064|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521065|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521205|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
521070|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521071|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521072|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521073|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521074|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521075|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521076|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521077|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521078|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521079|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521080|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521081|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521082|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521083|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521084|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521085|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521086|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521087|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521088|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521089|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521090|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521091|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521092|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521093|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521094|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521095|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521096|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521097|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521098|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521099|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521100|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521101|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521102|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521103|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521104|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521105|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521106|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521107|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521108|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521109|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521110|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521111|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521112|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521113|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521114|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521115|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521116|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521117|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521118|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521119|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521120|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521121|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521122|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521123|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521124|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521125|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521126|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521127|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521128|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521129|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521130|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521131|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521132|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521133|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521134|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521135|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521136|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521137|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521138|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521139|NCT00708110|E4|Reported Event|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
521140|NCT00708110|E3|Reported Event|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
521141|NCT00708110|E2|Reported Event|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
521142|NCT00708110|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
521143|NCT00708097|B1|Baseline|All Randomized Participants|All randomized participants who received at least one of the treatment dentifrices during the study and had at least one safety assessment after using the treatment dentifrice.
521144|NCT00708097|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521145|NCT00708097|P4|Participant Flow|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521146|NCT00708097|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521147|NCT00708097|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521206|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
531685|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
521148|NCT00708097|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521149|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521150|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521151|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521152|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521153|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521154|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521155|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521156|NCT00708097|O3|Outcome|NaMFP/ NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521157|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521158|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521159|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521160|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521161|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521162|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521163|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521164|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521165|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521166|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521167|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521168|NCT00708097|O1|Outcome|NaF/Carbopol Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521169|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521170|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521171|NCT00708097|E6|Reported Event|Overall|All participants received all treatments during the study
521172|NCT00708097|E5|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521173|NCT00708097|E4|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521174|NCT00708097|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521175|NCT00708097|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521176|NCT00708097|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
521177|NCT00708071|B1|Baseline|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521178|NCT00708071|P1|Participant Flow|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521179|NCT00708071|O1|Outcome|Facelift Participants|
521180|NCT00708071|O3|Outcome|SoC Looks Better|
521181|NCT00708071|O2|Outcome|FS VH S/D 4 Looks Better|
521182|NCT00708071|O1|Outcome|No Difference|
521183|NCT00708071|O1|Outcome|Facelift Participants|
521184|NCT00708071|O1|Outcome|Facelift Participants|
521185|NCT00708071|O8|Outcome|SoC - Day 14|
521186|NCT00708071|O7|Outcome|FS VH S/D 4 - Day 14|
521187|NCT00708071|O6|Outcome|SoC - Day 10|
521188|NCT00708071|O5|Outcome|FS VH S/D 4 - Day 10|
521189|NCT00708071|O4|Outcome|SoC - Day 7|
521190|NCT00708071|O3|Outcome|FS VH S/D 4 - Day 7|
521191|NCT00708071|O2|Outcome|SoC - Day 3|
521192|NCT00708071|O1|Outcome|FS VH S/D 4 - Day3|
521193|NCT00708071|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
521194|NCT00708071|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
521195|NCT00708071|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
521196|NCT00708071|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 Side|
521197|NCT00708071|O2|Outcome|FS VH S/D 4|
521198|NCT00708071|O1|Outcome|Standard of Care (SoC)|
521199|NCT00708071|O2|Outcome|FS VH S/D 4|
521200|NCT00708071|O1|Outcome|Standard of Care (SoC)|
521201|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
521202|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
521203|NCT00708071|O2|Outcome|Complete Resolution of Edema With SoC But Not FS VH S/D 4|
521204|NCT00708071|O1|Outcome|Complete Resolution of Edema With FS VH S/D 4 But Not SoC|
521209|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521210|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521211|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521212|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521213|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521214|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521215|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521216|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521217|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521218|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521219|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521220|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521221|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521222|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521223|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521224|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521225|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521226|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521227|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
521228|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
521229|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
521230|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
521231|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
521232|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
521233|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
521234|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
521235|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
521236|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
521237|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
521238|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
521239|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
521240|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
521241|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
521242|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
521243|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
521244|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
521245|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
521246|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
521247|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
521248|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
521249|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
521250|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
521251|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
521252|NCT00708071|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
521253|NCT00708071|E2|Reported Event|Localized to FS VH S/D 4 Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4.
521254|NCT00708071|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care.
521255|NCT00708032|B3|Baseline|Total|Total of all reporting groups
521256|NCT00708032|B2|Baseline|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
521257|NCT00708032|B1|Baseline|Spectacles|spectacles worn daily for 12 months
521258|NCT00708032|P2|Participant Flow|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
521259|NCT00708032|P1|Participant Flow|Spectacles|spectacles worn daily for 12 months
521260|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
521261|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
521262|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
521263|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
521264|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
521267|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
521268|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
521269|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
521270|NCT00708032|E2|Reported Event|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
521271|NCT00708032|E1|Reported Event|Spectacles|spectacles worn daily for 12 months
521272|NCT00708019|B3|Baseline|Total|Total of all reporting groups
521273|NCT00708019|B2|Baseline|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521274|NCT00708019|B1|Baseline|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521275|NCT00708019|P2|Participant Flow|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521276|NCT00708019|P1|Participant Flow|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521277|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521278|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521279|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521308|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521309|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521310|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521280|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521281|NCT00708019|E2|Reported Event|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521282|NCT00708019|E1|Reported Event|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
521283|NCT00707993|B3|Baseline|Total|Total of all reporting groups
521284|NCT00707993|B2|Baseline|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521285|NCT00707993|B1|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521286|NCT00707993|P2|Participant Flow|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521287|NCT00707993|P1|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521288|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521289|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521290|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521291|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521292|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521293|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521294|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521295|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521296|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521297|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521298|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521299|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521300|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521301|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521302|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521303|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521304|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521305|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521306|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521307|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521509|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
521311|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521312|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521313|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521314|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521315|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521316|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521317|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521318|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521319|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521320|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521321|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521322|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521323|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521324|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521325|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521326|NCT00707993|E2|Reported Event|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
521327|NCT00707993|E1|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
521328|NCT00707980|B1|Baseline|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521329|NCT00707980|P1|Participant Flow|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521330|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521331|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521332|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521333|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521334|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521335|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521336|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521337|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521338|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521339|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521340|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521341|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521342|NCT00707980|E1|Reported Event|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
521343|NCT00707967|B4|Baseline|Total|Total of all reporting groups
521344|NCT00707967|B3|Baseline|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521345|NCT00707967|B2|Baseline|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521346|NCT00707967|B1|Baseline|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521347|NCT00707967|P3|Participant Flow|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521348|NCT00707967|P2|Participant Flow|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521349|NCT00707967|P1|Participant Flow|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521350|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521351|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521352|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521353|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521354|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521355|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521356|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521357|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521358|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521359|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521360|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521361|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521362|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521363|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521364|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521365|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521366|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521367|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521368|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521369|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521370|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521371|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521372|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521373|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521374|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521375|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521376|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521377|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521378|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521379|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521380|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521381|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521382|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521383|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521384|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521385|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521386|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521387|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521388|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521389|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521390|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521391|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521392|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521393|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521394|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521395|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521396|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521397|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521510|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
521511|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
521398|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521399|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521400|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521401|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521402|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521403|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521404|NCT00707967|E3|Reported Event|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521405|NCT00707967|E2|Reported Event|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521406|NCT00707967|E1|Reported Event|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
521407|NCT00707954|B6|Baseline|Total|Total of all reporting groups
521408|NCT00707954|B5|Baseline|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521409|NCT00707954|B4|Baseline|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521410|NCT00707954|B3|Baseline|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521411|NCT00707954|B2|Baseline|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521412|NCT00707954|B1|Baseline|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521413|NCT00707954|P5|Participant Flow|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521414|NCT00707954|P4|Participant Flow|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521415|NCT00707954|P3|Participant Flow|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521416|NCT00707954|P2|Participant Flow|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521417|NCT00707954|P1|Participant Flow|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521418|NCT00707954|O5|Outcome|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521419|NCT00707954|O4|Outcome|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521420|NCT00707954|O3|Outcome|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521421|NCT00707954|O2|Outcome|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521422|NCT00707954|O1|Outcome|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521423|NCT00707954|E5|Reported Event|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521424|NCT00707954|E4|Reported Event|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521425|NCT00707954|E3|Reported Event|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521426|NCT00707954|E2|Reported Event|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521427|NCT00707954|E1|Reported Event|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
521428|NCT00707915|B1|Baseline|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521429|NCT00707915|P1|Participant Flow|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521430|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521431|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521432|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521433|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521434|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521435|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521436|NCT00707915|E1|Reported Event|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
521437|NCT00707863|B3|Baseline|Total|Total of all reporting groups
521438|NCT00707863|B2|Baseline|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
521439|NCT00707863|B1|Baseline|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
521440|NCT00707863|P2|Participant Flow|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
521441|NCT00707863|P1|Participant Flow|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
521442|NCT00707863|O2|Outcome|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
521443|NCT00707863|O1|Outcome|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
521444|NCT00707863|E2|Reported Event|Subjects Age: 26 - 50|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth per day for 8 weeks"
521445|NCT00707863|E1|Reported Event|Subjects Age: 18 - 25|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
521446|NCT00707759|B3|Baseline|Total|Total of all reporting groups
521447|NCT00707759|B2|Baseline|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
521448|NCT00707759|B1|Baseline|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
521449|NCT00707759|P2|Participant Flow|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
521450|NCT00707759|P1|Participant Flow|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
521451|NCT00707759|O2|Outcome|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
521452|NCT00707759|O1|Outcome|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
521453|NCT00707759|E2|Reported Event|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
521512|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
521513|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|
521514|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|
521515|NCT00707655|E2|Reported Event|Zalutumumab 8 mg/kg|8 weekly infusions
521454|NCT00707759|E1|Reported Event|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
521455|NCT00707746|B3|Baseline|Total|Total of all reporting groups
521456|NCT00707746|B2|Baseline|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521457|NCT00707746|B1|Baseline|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521458|NCT00707746|P2|Participant Flow|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521459|NCT00707746|P1|Participant Flow|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521460|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521461|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521462|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521463|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521464|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521465|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521466|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521467|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521468|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521469|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521470|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521471|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521472|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521473|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521474|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521475|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521476|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521477|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521478|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521479|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521480|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521481|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521482|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521483|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521484|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521485|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521486|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521487|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521488|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521489|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521490|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521491|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521492|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521493|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521494|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521495|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521496|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521497|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521498|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521499|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521500|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521501|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521502|NCT00707746|E2|Reported Event|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
521503|NCT00707746|E1|Reported Event|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
521504|NCT00707655|B3|Baseline|Total|Total of all reporting groups
521505|NCT00707655|B2|Baseline|Zalutumumab 8 mg/kg|8 weekly infusions
521506|NCT00707655|B1|Baseline|Zalutumumab 4 mg/kg|8 weekly infusions
521507|NCT00707655|P2|Participant Flow|Zalutumumab 8 mg/kg|8 weekly infusions
521508|NCT00707655|P1|Participant Flow|Zalutumumab 4 mg/kg|8 weekly infusions
521519|NCT00707577|B1|Baseline|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
521520|NCT00707577|P2|Participant Flow|Control|No maintenance program provided
521521|NCT00707577|P1|Participant Flow|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
521522|NCT00707577|O2|Outcome|Control|No maintenance program provided
521523|NCT00707577|O1|Outcome|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
521524|NCT00707577|E2|Reported Event|Control|No maintenance program provided
521525|NCT00707577|E1|Reported Event|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
521526|NCT00707486|B1|Baseline|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
521527|NCT00707486|P1|Participant Flow|Hemcon Dental Dressing With Pressure|Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.
521528|NCT00707486|O3|Outcome|Total|
521529|NCT00707486|O2|Outcome|Control: Gauze|
521530|NCT00707486|O1|Outcome|HemCon|Experimental
521531|NCT00707486|O3|Outcome|Total|
521532|NCT00707486|O2|Outcome|Control: Gauze|
521533|NCT00707486|O1|Outcome|HemCon|Experimental
521534|NCT00707486|E1|Reported Event|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
521535|NCT00707447|B3|Baseline|Total|Total of all reporting groups
521536|NCT00707447|B2|Baseline|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
521537|NCT00707447|B1|Baseline|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
521538|NCT00707447|P2|Participant Flow|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
521539|NCT00707447|P1|Participant Flow|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
521540|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521541|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521542|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521543|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521544|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521545|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521546|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521547|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521548|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521549|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521550|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521628|NCT00707161|O1|Outcome|Treatment Arm (Radiation & Cisplatin)|Group of participants receiving Radiation and Cisplatin.
521551|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521552|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521553|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521554|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521555|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521556|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521557|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521558|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
521559|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
521560|NCT00707447|E2|Reported Event|2/PREDIAS|Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle
521561|NCT00707447|E1|Reported Event|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
521562|NCT00707343|B1|Baseline|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
521563|NCT00707343|P1|Participant Flow|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
521564|NCT00707343|O1|Outcome|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
521565|NCT00707343|E1|Reported Event|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
521566|NCT00707239|B4|Baseline|Total|Total of all reporting groups
521567|NCT00707239|B3|Baseline|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521568|NCT00707239|B2|Baseline|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521569|NCT00707239|B1|Baseline|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521570|NCT00707239|P3|Participant Flow|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521571|NCT00707239|P2|Participant Flow|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521572|NCT00707239|P1|Participant Flow|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521573|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521574|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521590|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521575|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521576|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously every 12 hrs at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
521577|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
521578|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
521579|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
521580|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
521581|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521582|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521583|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
521584|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521585|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521586|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521587|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521588|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521589|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521627|NCT00707161|P1|Participant Flow|Treatment Arm (Radiation Therapy & Cisplatin)|All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.
521591|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521592|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521593|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521594|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521595|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521596|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521597|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521598|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521599|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521600|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521601|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521602|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521603|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521604|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521605|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521606|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521607|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521608|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521609|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521610|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521611|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521612|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521613|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521614|NCT00707239|E3|Reported Event|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521615|NCT00707239|E2|Reported Event|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
521616|NCT00707239|E1|Reported Event|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
521617|NCT00707174|B3|Baseline|Total|Total of all reporting groups
521618|NCT00707174|B2|Baseline|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
521619|NCT00707174|B1|Baseline|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
521620|NCT00707174|P2|Participant Flow|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
521621|NCT00707174|P1|Participant Flow|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
521622|NCT00707174|O2|Outcome|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
521623|NCT00707174|O1|Outcome|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
521624|NCT00707174|E2|Reported Event|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
521625|NCT00707174|E1|Reported Event|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
521626|NCT00707161|B1|Baseline|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
531686|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
521629|NCT00707161|E1|Reported Event|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
521630|NCT00707057|B3|Baseline|Total|Total of all reporting groups
521631|NCT00707057|B2|Baseline|Placebo|Participants received placebo tablet twice daily (BID)
521632|NCT00707057|B1|Baseline|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521633|NCT00707057|P2|Participant Flow|Placebo|Participants received placebo tablet twice daily (BID)
521634|NCT00707057|P1|Participant Flow|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521635|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521636|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521637|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521638|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521639|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521640|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521641|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521642|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521643|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521644|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521645|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521646|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521647|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521648|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521649|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521650|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521651|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521652|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521653|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521654|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521655|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521656|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521657|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521658|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521659|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521660|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521661|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
521662|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521663|NCT00707057|E2|Reported Event|Placebo|Participants received placebo tablet twice daily (BID)
521664|NCT00707057|E1|Reported Event|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
521665|NCT00707031|B3|Baseline|Total|Total of all reporting groups
521666|NCT00707031|B2|Baseline|Exenatide|1-step initiation regimen of exenatide: 5 mcg BID subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
521667|NCT00707031|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
521668|NCT00707031|P2|Participant Flow|Exenatide|1-step initiation regimen of exenatide: 5 mcg twice daily (BID) subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
521669|NCT00707031|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
521670|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
521671|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521672|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
521673|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521674|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
521675|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521676|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
521677|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521678|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
521679|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521680|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
521681|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521682|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
521683|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521684|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
521685|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521686|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
521687|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
521688|NCT00707031|E2|Reported Event|Exenatide|1-step initiation regimen of exenatide.
521689|NCT00707031|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
521690|NCT00706992|B8|Baseline|Total|Total of all reporting groups
521691|NCT00706992|B7|Baseline|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521692|NCT00706992|B6|Baseline|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
521693|NCT00706992|B5|Baseline|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521694|NCT00706992|B4|Baseline|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521695|NCT00706992|B3|Baseline|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521696|NCT00706992|B2|Baseline|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
521697|NCT00706992|B1|Baseline|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
521698|NCT00706992|P7|Participant Flow|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521699|NCT00706992|P6|Participant Flow|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
521700|NCT00706992|P5|Participant Flow|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521701|NCT00706992|P4|Participant Flow|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521702|NCT00706992|P3|Participant Flow|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521703|NCT00706992|P2|Participant Flow|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
521704|NCT00706992|P1|Participant Flow|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
521705|NCT00706992|O7|Outcome|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521706|NCT00706992|O6|Outcome|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
521707|NCT00706992|O5|Outcome|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521708|NCT00706992|O4|Outcome|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521709|NCT00706992|O3|Outcome|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521710|NCT00706992|O2|Outcome|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
521711|NCT00706992|O1|Outcome|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
521712|NCT00706992|O1|Outcome|Arm I - 6|Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
521713|NCT00706992|E7|Reported Event|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521714|NCT00706992|E6|Reported Event|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
521715|NCT00706992|E5|Reported Event|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
521716|NCT00706992|E4|Reported Event|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521717|NCT00706992|E3|Reported Event|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
521718|NCT00706992|E2|Reported Event|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
521719|NCT00706992|E1|Reported Event|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
521720|NCT00706979|B3|Baseline|Total|Total of all reporting groups
521721|NCT00706979|B2|Baseline|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
521722|NCT00706979|B1|Baseline|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
521723|NCT00706979|P2|Participant Flow|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
521724|NCT00706979|P1|Participant Flow|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
521725|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
521726|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
521727|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
521728|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
521729|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
521730|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
521731|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
521732|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
521733|NCT00706979|E2|Reported Event|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
521734|NCT00706979|E1|Reported Event|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
521735|NCT00706966|B1|Baseline|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
521736|NCT00706966|P1|Participant Flow|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
521737|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 6 months.
521738|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 3 months.
521739|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 1 month.
521740|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at Baseline.
521741|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 6 months.
521742|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 3 months.
521743|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 1 month.
521834|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521744|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at Baseline.
521745|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 6 months.
521746|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 3 months.
521747|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 1 month.
521748|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at Baseline.
521749|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 6 months.
521750|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 3 months.
521751|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 1 month.
521752|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at Baseline.
521753|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 6 months.
521754|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 3 months.
521755|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 1 month.
521756|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at Baseline.
521757|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 6 months.
521758|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 3 months.
521759|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 1 month.
521760|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at baseline.
521761|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
521762|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
521763|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
521764|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at Baseline.
521765|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
521766|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
521767|NCT00706966|E1|Reported Event|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride: 6 months of dutasteride 3.5 mg daily"
521768|NCT00706914|B4|Baseline|Total|Total of all reporting groups
521769|NCT00706914|B3|Baseline|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521770|NCT00706914|B2|Baseline|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521771|NCT00706914|B1|Baseline|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521772|NCT00706914|P3|Participant Flow|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521773|NCT00706914|P2|Participant Flow|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521774|NCT00706914|P1|Participant Flow|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521775|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521776|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521777|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521778|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521779|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521780|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521781|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521782|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521783|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521784|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521785|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521786|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521787|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521788|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521789|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521790|NCT00706914|E3|Reported Event|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
521791|NCT00706914|E2|Reported Event|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
521792|NCT00706914|E1|Reported Event|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
521793|NCT00706901|B4|Baseline|Total|Total of all reporting groups
521794|NCT00706901|B3|Baseline|Arm 3 TCC|Treatment Control condition
521795|NCT00706901|B2|Baseline|Arm 2 IHMD|In-Home-Messaging Device
521796|NCT00706901|B1|Baseline|Arm 1 GMI|Group Motivational Interviewing
521797|NCT00706901|P3|Participant Flow|Arm 3 TCC|Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
521798|NCT00706901|P2|Participant Flow|Arm 2 IHMD|Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
521799|NCT00706901|P1|Participant Flow|Arm 1 GMI|Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
521800|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
521801|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
521802|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
521803|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
521804|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
521805|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
521806|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
521807|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
521808|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
521809|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
521810|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
521811|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
521812|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
521813|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
521814|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
521815|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
521816|NCT00706901|O2|Outcome|Arm 2 IHMD|In Home Messaging Device
521817|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
521818|NCT00706901|E3|Reported Event|Arm 3 TCC|Treatment Control Condition
521819|NCT00706901|E2|Reported Event|Arm 2 IHMD|In Home Messaging Device
521820|NCT00706901|E1|Reported Event|Arm 1 GMI|Group Motivational Interviewing
521821|NCT00706849|B3|Baseline|Total|Total of all reporting groups
521822|NCT00706849|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521823|NCT00706849|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521824|NCT00706849|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521825|NCT00706849|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521826|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521827|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521828|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521829|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521830|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521831|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521832|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521833|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521835|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521836|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521837|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521838|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521839|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521840|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521841|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521842|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521843|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521844|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521845|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521846|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521847|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521848|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521849|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521850|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521851|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521852|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521853|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521854|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521855|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521856|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521857|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521858|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521859|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521860|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521861|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521862|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521863|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521864|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521865|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521866|NCT00706849|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
521867|NCT00706849|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
521868|NCT00706836|B1|Baseline|All 3 Treatments (Cross-Over Design)|"Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo~All subjects received all 3 treatments on different days.~Sequence data not available."
521869|NCT00706836|P1|Participant Flow|All Study Participants|"Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo~All participants received all 3 treatments on different days.~Sequence not available."
521870|NCT00706836|O3|Outcome|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
521871|NCT00706836|O2|Outcome|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
521872|NCT00706836|O1|Outcome|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
521873|NCT00706836|E3|Reported Event|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
521874|NCT00706836|E2|Reported Event|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
521875|NCT00706836|E1|Reported Event|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
521876|NCT00706823|B3|Baseline|Total|Total of all reporting groups
521877|NCT00706823|B2|Baseline|LMA-Unique|Patients who received LMA-Unique for intubation
521878|NCT00706823|B1|Baseline|I-gel-SGA|Patients who received i-gel SGA for intubation
521879|NCT00706823|P2|Participant Flow|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521918|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
531687|NCT00684307|O5|Outcome|VKA INR 2-3|
521880|NCT00706823|P1|Participant Flow|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521881|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521882|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521883|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521884|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521885|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521886|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521887|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521888|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521889|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521890|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521891|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521892|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521893|NCT00706823|E2|Reported Event|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
521919|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521956|NCT00706719|P3|Participant Flow|Group C Androxal With Wash Out|25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone
521894|NCT00706823|E1|Reported Event|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
521895|NCT00706810|B1|Baseline|All Groups|
521896|NCT00706810|P1|Participant Flow|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
521897|NCT00706810|O1|Outcome|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
521898|NCT00706810|O1|Outcome|All Groups|
521899|NCT00706810|E1|Reported Event|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
521900|NCT00706797|B3|Baseline|Total|Total of all reporting groups
521901|NCT00706797|B2|Baseline|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521902|NCT00706797|B1|Baseline|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521903|NCT00706797|P2|Participant Flow|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521904|NCT00706797|P1|Participant Flow|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521905|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521906|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521907|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521908|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521909|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521910|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521911|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521912|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521913|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521914|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521915|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521916|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521917|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521920|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521921|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521922|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521923|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521924|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521925|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521926|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521927|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521928|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521929|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521930|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521931|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521932|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521933|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521934|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521935|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521936|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521937|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521938|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521939|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521940|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521941|NCT00706797|E2|Reported Event|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
521942|NCT00706797|E1|Reported Event|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
521943|NCT00706784|B3|Baseline|Total|Total of all reporting groups
521944|NCT00706784|B2|Baseline|36 mg Leuprolide for 3 Days|
521945|NCT00706784|B1|Baseline|18 mg Leuprolide for 3 Days|
521946|NCT00706784|P2|Participant Flow|36 mg Leuprolide for 3 Days|
521947|NCT00706784|P1|Participant Flow|18 mg Leuprolide for 3 Days|
521948|NCT00706784|O2|Outcome|36 mg Leuprolide for 3 Days|
521949|NCT00706784|O1|Outcome|18 mg Leuprolide for 3 Days|
521950|NCT00706784|E2|Reported Event|36 mg Leuprolide for 3 Days|
521951|NCT00706784|E1|Reported Event|18 mg Leuprolide for 3 Days|
521952|NCT00706719|B4|Baseline|Total|Total of all reporting groups
521953|NCT00706719|B3|Baseline|Group C Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
521954|NCT00706719|B2|Baseline|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
521955|NCT00706719|B1|Baseline|Group A Testim|1% Testim gel applied daily
531688|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
521957|NCT00706719|P2|Participant Flow|Group B Androxal no Washout|25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
521958|NCT00706719|P1|Participant Flow|Group A Testim (Topical Testosterone)|1% Testim gel applied once daily
521959|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
521960|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
521961|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
521962|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
521963|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
521964|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
521965|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
521966|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
521967|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
521968|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
521969|NCT00706719|E3|Reported Event|Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
521970|NCT00706719|E2|Reported Event|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
521971|NCT00706719|E1|Reported Event|Group A Testim|1% Testim gel applied daily
521972|NCT00706706|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
521973|NCT00706706|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
521974|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
521975|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
521976|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
521977|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
521978|NCT00706706|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
521979|NCT00706654|B4|Baseline|Total|Total of all reporting groups
521980|NCT00706654|B3|Baseline|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
521981|NCT00706654|B2|Baseline|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
521982|NCT00706654|B1|Baseline|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
521983|NCT00706654|P4|Participant Flow|Aripiprazole Depot 25 or 50 mg|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
521984|NCT00706654|P3|Participant Flow|Aripiprazole 10-30 mg Orally|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
521985|NCT00706654|P2|Participant Flow|Aripiprazole Depot 300 or 400 mg|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
521986|NCT00706654|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
521987|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
521988|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
521989|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
521990|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
521991|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
521992|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
521993|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
521994|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
521995|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
521996|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
521997|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
531689|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
521998|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
521999|NCT00706654|E5|Reported Event|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
522000|NCT00706654|E4|Reported Event|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
522001|NCT00706654|E3|Reported Event|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
522002|NCT00706654|E2|Reported Event|All Patients - Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
522003|NCT00706654|E1|Reported Event|All Patients - Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
522004|NCT00706641|B1|Baseline|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522005|NCT00706641|P1|Participant Flow|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522006|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522007|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522008|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522009|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522010|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522011|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522012|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522053|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522013|NCT00706641|E1|Reported Event|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
522014|NCT00706628|B5|Baseline|Total|Total of all reporting groups
522015|NCT00706628|B4|Baseline|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
522016|NCT00706628|B3|Baseline|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522017|NCT00706628|B2|Baseline|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522018|NCT00706628|B1|Baseline|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522019|NCT00706628|P4|Participant Flow|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events (AE) reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
522020|NCT00706628|P3|Participant Flow|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522021|NCT00706628|P2|Participant Flow|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522022|NCT00706628|P1|Participant Flow|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522023|NCT00706628|O1|Outcome|Combination Therapy of BIBF 1120 and BIBW 2992|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~C12,14 values of BIBF 1120 BS after sequential alternating 7−days administration of 250 mg BIBF 1120 bid;~C24,7, C24,14 and C24,42 values of BIBW 2992 BS after sequential alternating 7−days administration of 40 mg BIBW 2992 qd"
522024|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522025|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522026|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
522027|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522028|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522029|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522052|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522084|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
531690|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
522030|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
522031|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522032|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522033|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522034|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522035|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522036|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522037|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522038|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522039|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522040|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522041|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522042|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522043|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522044|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522045|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522046|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522047|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522048|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522049|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522050|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522051|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522085|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522054|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522055|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522056|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522057|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522058|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522059|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522060|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522061|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle. The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged. Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
522062|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522063|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522064|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522065|NCT00706628|E4|Reported Event|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
522066|NCT00706628|E3|Reported Event|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
522067|NCT00706628|E2|Reported Event|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522068|NCT00706628|E1|Reported Event|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
522069|NCT00706589|B3|Baseline|Total|Total of all reporting groups
522070|NCT00706589|B2|Baseline|Placebo|Placebo 2mg,5mg,10mg,15mg
522071|NCT00706589|B1|Baseline|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
522072|NCT00706589|P2|Participant Flow|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
522073|NCT00706589|P1|Participant Flow|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O
522074|NCT00706589|O2|Outcome|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg
522075|NCT00706589|O1|Outcome|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg
522076|NCT00706589|E2|Reported Event|Placebo|Placebo 2mg,5mg,10mg,15mg
522077|NCT00706589|E1|Reported Event|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
522078|NCT00706563|B3|Baseline|Total|Total of all reporting groups
522079|NCT00706563|B2|Baseline|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522080|NCT00706563|B1|Baseline|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522081|NCT00706563|P2|Participant Flow|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522082|NCT00706563|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522083|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522086|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522087|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522088|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522089|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522090|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522091|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522092|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522093|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522094|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522095|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522096|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522097|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522098|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522099|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522100|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522101|NCT00706563|E2|Reported Event|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
522102|NCT00706563|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
522103|NCT00706550|B3|Baseline|Total|Total of all reporting groups
522104|NCT00706550|B2|Baseline|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
522105|NCT00706550|B1|Baseline|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
522106|NCT00706550|P2|Participant Flow|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522107|NCT00706550|P1|Participant Flow|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522108|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522109|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522110|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522111|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522112|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522113|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522114|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522115|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522116|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522117|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522118|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
522119|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
522120|NCT00706550|E2|Reported Event|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
531691|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
522121|NCT00706550|E1|Reported Event|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
522122|NCT00706485|B1|Baseline|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
522123|NCT00706485|P1|Participant Flow|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
522124|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
522125|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
522126|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
522127|NCT00706485|E1|Reported Event|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
522128|NCT00706446|B7|Baseline|Total|Total of all reporting groups
522129|NCT00706446|B6|Baseline|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522130|NCT00706446|B5|Baseline|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522131|NCT00706446|B4|Baseline|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522132|NCT00706446|B3|Baseline|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
522133|NCT00706446|B2|Baseline|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522209|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522210|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522211|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
531692|NCT00684307|O5|Outcome|VKA INR 2-3|
522134|NCT00706446|B1|Baseline|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522135|NCT00706446|P6|Participant Flow|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522136|NCT00706446|P5|Participant Flow|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522137|NCT00706446|P4|Participant Flow|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522138|NCT00706446|P3|Participant Flow|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
522139|NCT00706446|P2|Participant Flow|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522140|NCT00706446|P1|Participant Flow|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522212|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522213|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
531693|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
522141|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522142|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522143|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522144|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
522145|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522146|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522147|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522214|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522215|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
531694|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
522148|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522149|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522150|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
522151|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522152|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522153|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522154|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522216|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522217|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522155|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522156|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
522157|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522158|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522159|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522160|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522161|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522218|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522219|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
531695|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
522162|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
522163|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522164|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522165|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522166|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522167|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
522168|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
522220|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522221|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
523783|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
522169|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522170|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
522171|NCT00706446|E6|Reported Event|6 - LABA/ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
522172|NCT00706446|E5|Reported Event|5 - LABA/ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
522173|NCT00706446|E4|Reported Event|4 - LABA/ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
522174|NCT00706446|E3|Reported Event|3 - Tio/ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
522175|NCT00706446|E2|Reported Event|2 - Tio/ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
522222|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522223|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
523784|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
522176|NCT00706446|E1|Reported Event|1 - Tio/ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
522177|NCT00706433|B5|Baseline|Total|Total of all reporting groups
522178|NCT00706433|B4|Baseline|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522179|NCT00706433|B3|Baseline|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522180|NCT00706433|B2|Baseline|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522181|NCT00706433|B1|Baseline|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522182|NCT00706433|P4|Participant Flow|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522183|NCT00706433|P3|Participant Flow|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522184|NCT00706433|P2|Participant Flow|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522185|NCT00706433|P1|Participant Flow|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522186|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522187|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522188|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522189|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522190|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522191|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522192|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522193|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522194|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522195|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522196|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522197|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522198|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522199|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522200|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522201|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522202|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522203|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522204|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522205|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522206|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522207|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522208|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522224|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522225|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522226|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522227|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522228|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522229|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522230|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522231|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522232|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522233|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522234|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522235|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522236|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522237|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522238|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522239|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522240|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522241|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522242|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522243|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522244|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522245|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522246|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522247|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522248|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522249|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522250|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522251|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522252|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522253|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522254|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522255|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522256|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522257|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522258|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522259|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522874|NCT00705679|E5|Reported Event|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
522260|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522261|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522262|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522263|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522264|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522265|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522266|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522267|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522268|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522269|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522270|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522271|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522272|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522273|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522274|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522275|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522276|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522277|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522278|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522279|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522280|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522281|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522282|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522283|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522284|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522285|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522286|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522287|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522288|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522289|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522290|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522291|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522292|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522293|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522294|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522295|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522971|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522296|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522297|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522298|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522299|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522300|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522301|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522302|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522303|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522304|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522305|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522306|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522307|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522308|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522309|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522310|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522311|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522312|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522313|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522314|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522315|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522316|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522317|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522318|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522319|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522320|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522321|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522322|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522323|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522324|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522325|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522326|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522327|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522328|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522329|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522330|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522331|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
523115|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
522332|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522333|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522334|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522335|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522336|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522337|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522338|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522339|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522340|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522341|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522342|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522343|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522344|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522345|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522346|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522347|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522348|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522349|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522350|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522351|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522352|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522353|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522354|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522355|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522356|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522357|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522358|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522359|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522360|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522361|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522362|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522363|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522364|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522365|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522366|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522367|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
523116|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
522368|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522369|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522370|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522371|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522372|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522373|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522374|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522375|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522376|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522377|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522378|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522379|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522380|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522381|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522382|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522383|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522384|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522385|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522386|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522387|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522388|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522389|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522390|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522391|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522392|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522393|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522394|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522395|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522396|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522397|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522398|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522399|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522400|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522401|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522402|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522403|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
523117|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
522404|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522405|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522406|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522407|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522408|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522409|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522410|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522411|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522412|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522413|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522414|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522415|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522416|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522417|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522418|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522419|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522420|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522421|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522422|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522423|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522424|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522425|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522426|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522427|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522428|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522429|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522430|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522431|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522432|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522433|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522434|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522435|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522436|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522437|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522438|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522439|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
523118|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
522440|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522441|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522442|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522443|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522444|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522445|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522446|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522447|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522448|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522449|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522450|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522451|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522452|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522453|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522454|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522455|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522456|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522457|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522458|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522459|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522460|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522461|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522462|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522463|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522464|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522465|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522466|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522467|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522468|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522469|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522470|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522471|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522472|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522473|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522474|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522475|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
523119|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
522476|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522477|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522478|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522479|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522480|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522481|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522482|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522483|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522484|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522485|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522486|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522487|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522488|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522489|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522490|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522491|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522492|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522493|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522494|NCT00706433|E4|Reported Event|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
522495|NCT00706433|E3|Reported Event|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522496|NCT00706433|E2|Reported Event|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
522497|NCT00706433|E1|Reported Event|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
522498|NCT00706407|B3|Baseline|Total|Total of all reporting groups
522499|NCT00706407|B2|Baseline|Unobstructed|Patients with obstruction
522500|NCT00706407|B1|Baseline|Obstructed|All patients who had data analyzed
522501|NCT00706407|P1|Participant Flow|Fully Integrated Uro-NIRS:UDS|As part of standard care subjects will be undergoing a standard bladder pressure diagnostic procedure. This standard procedure will involve the insertion of a catheter (a plastic tube) into the urethra and the measurement of pressure within the bladder. For subjects taking part in this study, the health of the bladder will measured by using light instead of pressure. A patch, the size of cell phone or deck of playing cards, will be taped to the skin in the middle of the abdomen, above the bladder. Using laser light that is 300 billion times weaker than the light from a regular household 100-Watt light bulb, the Laborie and Urodynamic device will take measurements through the skin without inserting anything into the body.
522502|NCT00706407|O3|Outcome|Totals|Total number of participants included
522503|NCT00706407|O2|Outcome|Number Unobstructed|Free Flow and Pressure flow NIRS patterns
522504|NCT00706407|O1|Outcome|Number Obstructed|Free Flow and pressure flow NIRS patterns
522505|NCT00706407|E2|Reported Event|Unobstructed|Those without BOO
522506|NCT00706407|E1|Reported Event|Obstructed|Those with BOO
522507|NCT00706355|B5|Baseline|Total|Total of all reporting groups
522508|NCT00706355|B4|Baseline|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522509|NCT00706355|B3|Baseline|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522510|NCT00706355|B2|Baseline|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522511|NCT00706355|B1|Baseline|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522512|NCT00706355|P4|Participant Flow|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522513|NCT00706355|P3|Participant Flow|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522514|NCT00706355|P2|Participant Flow|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522515|NCT00706355|P1|Participant Flow|PF-04217903 50 mg|Two tablets 25 milligram (mg) PF-04217903 administered orally twice a day in continuous 21-day cycles.
522516|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522517|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522518|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522519|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522520|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522521|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522522|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522523|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522524|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522525|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522526|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522527|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522528|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522529|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522530|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522531|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522532|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522533|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522534|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522535|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522536|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522537|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522538|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522539|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522540|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522541|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522542|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522543|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522544|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522545|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522546|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522547|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522548|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522549|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522550|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522551|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522552|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522553|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522554|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522555|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522556|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522557|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522558|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522559|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522560|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
523120|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
522561|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
522562|NCT00706355|E4|Reported Event|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522563|NCT00706355|E3|Reported Event|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522564|NCT00706355|E2|Reported Event|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522565|NCT00706355|E1|Reported Event|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
522566|NCT00706342|B1|Baseline|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522567|NCT00706342|P1|Participant Flow|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522568|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522569|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522570|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522571|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522572|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522573|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522574|NCT00706342|E1|Reported Event|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
522575|NCT00706329|B1|Baseline|Deflux|Treatment with Deflux.
522576|NCT00706329|P1|Participant Flow|Deflux|Treatment with Deflux.
522577|NCT00706329|O1|Outcome|Close Belly Button or Umbilical Hernia|
522578|NCT00706329|E1|Reported Event|Deflux|Treatment with Deflux.
522579|NCT00706134|B5|Baseline|Total|Total of all reporting groups
522580|NCT00706134|B4|Baseline|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522581|NCT00706134|B3|Baseline|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522582|NCT00706134|B2|Baseline|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522583|NCT00706134|B1|Baseline|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522584|NCT00706134|P4|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522585|NCT00706134|P3|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522586|NCT00706134|P2|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522587|NCT00706134|P1|Participant Flow|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522588|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522589|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522590|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522591|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522592|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522593|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522594|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522595|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522596|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522597|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522598|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522599|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522600|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522601|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522602|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522603|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522604|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522605|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522606|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522607|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522608|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522609|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522610|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522611|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522612|NCT00706134|E4|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
522613|NCT00706134|E3|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
522614|NCT00706134|E2|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
522615|NCT00706134|E1|Reported Event|Placebo|Placebo tablet taken once daily in the morning with a light meal.
522616|NCT00706121|B5|Baseline|Total|Total of all reporting groups
522617|NCT00706121|B4|Baseline|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
522618|NCT00706121|B3|Baseline|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
522619|NCT00706121|B2|Baseline|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
522620|NCT00706121|B1|Baseline|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
522621|NCT00706121|P4|Participant Flow|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
522622|NCT00706121|P3|Participant Flow|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
522623|NCT00706121|P2|Participant Flow|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
522624|NCT00706121|P1|Participant Flow|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
522625|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
522626|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
522627|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
522628|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
522629|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
522630|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
522631|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
522632|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
522633|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
522634|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
522635|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
522636|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
522637|NCT00706121|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
522638|NCT00706121|O3|Outcome|Combination|Vitamin E + selenium
522639|NCT00706121|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
522640|NCT00706121|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
522641|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- Vitamin E
522642|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- Vitamin E
522643|NCT00706121|O2|Outcome|Selenium Placebo|Selenium Placebo +/- Vitamin E
522644|NCT00706121|O1|Outcome|Active Selenium|Active Selenium +/- Vitamin E
522645|NCT00706121|E4|Reported Event|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
522646|NCT00706121|E3|Reported Event|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
522647|NCT00706121|E2|Reported Event|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
522648|NCT00706121|E1|Reported Event|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
522649|NCT00706095|B4|Baseline|Total|Total of all reporting groups
522650|NCT00706095|B3|Baseline|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
522651|NCT00706095|B2|Baseline|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
522652|NCT00706095|B1|Baseline|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
522653|NCT00706095|P3|Participant Flow|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
522654|NCT00706095|P2|Participant Flow|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
522655|NCT00706095|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
522656|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
522657|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
522658|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
522659|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
522660|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
522661|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
522662|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
522663|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
522664|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
522665|NCT00706095|E3|Reported Event|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
522666|NCT00706095|E2|Reported Event|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
522667|NCT00706095|E1|Reported Event|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
522668|NCT00706030|B5|Baseline|Total|Total of all reporting groups
522669|NCT00706030|B4|Baseline|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
522670|NCT00706030|B3|Baseline|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
522671|NCT00706030|B2|Baseline|Neratinib 240 mg + Vinorelbine 25 mg/m²|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
522672|NCT00706030|B1|Baseline|Neratinib 160 mg + Vinorelbine 25 mg/m²|Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
522673|NCT00706030|P4|Participant Flow|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
522674|NCT00706030|P3|Participant Flow|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
522675|NCT00706030|P2|Participant Flow|Neratinib 240 mg + Vinorelbine 25 mg/m²|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
522676|NCT00706030|P1|Participant Flow|Neratinib 160 mg + Vinorelbine 25 mg/m²|Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks
522677|NCT00706030|O1|Outcome|Part 1|Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with Vinorelbine 25 mg/m2 IV on days 1 and 8 every 3 weeks, associated with the dose limiting toxicity data.
522678|NCT00706030|O2|Outcome|Neratinib 20 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure.
522679|NCT00706030|O1|Outcome|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure.
522680|NCT00706030|O2|Outcome|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
522681|NCT00706030|O1|Outcome|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
522682|NCT00706030|O2|Outcome|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
522683|NCT00706030|O1|Outcome|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
522684|NCT00706030|O2|Outcome|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure
522685|NCT00706030|O1|Outcome|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure
522686|NCT00706030|E4|Reported Event|Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with prior Lapatinib exposure.
522687|NCT00706030|E3|Reported Event|Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks, with no prior lapatinib exposure.
522688|NCT00706030|E2|Reported Event|Neratinib 240 mg + Vinorelbine 25 mg/m²|Neratinib 240 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
522689|NCT00706030|E1|Reported Event|Neratinib 160 mg + Vinorelbine 25 mg/m²|Neratinib 160 mg qd + Vinorelbine 25 mg/m² IV on days 1 and 8 every 3 weeks.
522690|NCT00706004|B1|Baseline|Lubiprostone|24 micrograms twice daily
522691|NCT00706004|P1|Participant Flow|Lubiprostone|24 micrograms twice daily
522692|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522693|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522694|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522695|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522696|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522697|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522698|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522699|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522700|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522701|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522702|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522703|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522704|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522705|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522706|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522707|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522708|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522709|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
522710|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
522711|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
522712|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
522713|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
522714|NCT00706004|E1|Reported Event|Lubiprostone|24 micrograms twice daily
522715|NCT00705939|B4|Baseline|Total|Total of all reporting groups
523785|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
522716|NCT00705939|B3|Baseline|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
522717|NCT00705939|B2|Baseline|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
522718|NCT00705939|B1|Baseline|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522719|NCT00705939|P3|Participant Flow|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
522720|NCT00705939|P2|Participant Flow|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
522721|NCT00705939|P1|Participant Flow|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522722|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
522723|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
522724|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522725|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
522726|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
522727|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522728|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
522729|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
522730|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522731|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
522732|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
522733|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522734|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
522735|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
522736|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522737|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
522738|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
522739|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522740|NCT00705939|E3|Reported Event|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
522741|NCT00705939|E2|Reported Event|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
522742|NCT00705939|E1|Reported Event|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
522743|NCT00705874|B8|Baseline|Total|Total of all reporting groups
522744|NCT00705874|B7|Baseline|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
522745|NCT00705874|B6|Baseline|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
522746|NCT00705874|B5|Baseline|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
522747|NCT00705874|B4|Baseline|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
522748|NCT00705874|B3|Baseline|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
522749|NCT00705874|B2|Baseline|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
522750|NCT00705874|B1|Baseline|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
522751|NCT00705874|P7|Participant Flow|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
522752|NCT00705874|P6|Participant Flow|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
522753|NCT00705874|P5|Participant Flow|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
522754|NCT00705874|P4|Participant Flow|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
522755|NCT00705874|P3|Participant Flow|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
522756|NCT00705874|P2|Participant Flow|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
522757|NCT00705874|P1|Participant Flow|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
522758|NCT00705874|O7|Outcome|PG11047/Sunitinib|"PG-11047 in combination with Sunitinib.~The MTD of PG-11047 was undetermineable due to only 2 evaluable patients in this treatment group"
522759|NCT00705874|O6|Outcome|PG11047/5-Flurouracil|CGC-11047 in combination with 5-Flurouracil / Leucovorin
522760|NCT00705874|O5|Outcome|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
522761|NCT00705874|O4|Outcome|PG11047/Erlotinib|PG-11047 in combination with Erlotinib
522762|NCT00705874|O3|Outcome|PG11047/Bevacizumab|PG-11047 in combination with Bevacizumab
522763|NCT00705874|O2|Outcome|PG11047/Docetaxel|PG-11047 in combination with Docetaxel
522764|NCT00705874|O1|Outcome|PG11047/Gemcitabine|PG-11047 in combination with Gemcitabine
522765|NCT00705874|E7|Reported Event|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
522766|NCT00705874|E6|Reported Event|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
522767|NCT00705874|E5|Reported Event|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
522768|NCT00705874|E4|Reported Event|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
522769|NCT00705874|E3|Reported Event|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
522770|NCT00705874|E2|Reported Event|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
522771|NCT00705874|E1|Reported Event|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
522772|NCT00705783|B3|Baseline|Total|Total of all reporting groups
522773|NCT00705783|B2|Baseline|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522774|NCT00705783|B1|Baseline|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522775|NCT00705783|P3|Participant Flow|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522776|NCT00705783|P2|Participant Flow|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522777|NCT00705783|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot.
522778|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522779|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522780|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522781|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522782|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522783|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522784|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522785|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522786|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522787|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522788|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522789|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522790|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522791|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522792|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522793|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522794|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522795|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522796|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
522797|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522798|NCT00705783|E5|Reported Event|Placebo Depot - Depot Maintenance Phase|Patients received placebo intramuscularly every 28 days for 52 weeks.
522799|NCT00705783|E4|Reported Event|Aripiprazole Depot - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
522800|NCT00705783|E3|Reported Event|Depot Stabilization Phase|During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot.
522801|NCT00705783|E2|Reported Event|Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
522802|NCT00705783|E1|Reported Event|Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
522803|NCT00705757|B4|Baseline|Total|Total of all reporting groups
522804|NCT00705757|B3|Baseline|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
522805|NCT00705757|B2|Baseline|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
522806|NCT00705757|B1|Baseline|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
522807|NCT00705757|P3|Participant Flow|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
522808|NCT00705757|P2|Participant Flow|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
522809|NCT00705757|P1|Participant Flow|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
522810|NCT00705757|O3|Outcome|Travatan|Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s).
522811|NCT00705757|O2|Outcome|Xalatan|Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s).
522812|NCT00705757|O1|Outcome|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s).
522813|NCT00705757|E3|Reported Event|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
522814|NCT00705757|E2|Reported Event|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
522815|NCT00705757|E1|Reported Event|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
522816|NCT00705718|B3|Baseline|Total|Total of all reporting groups
522817|NCT00705718|B2|Baseline|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522818|NCT00705718|B1|Baseline|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522819|NCT00705718|P2|Participant Flow|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522820|NCT00705718|P1|Participant Flow|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522821|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522822|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522823|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522824|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522825|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522826|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522827|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522828|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522829|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522830|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522831|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
522832|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
522833|NCT00705718|E2|Reported Event|2. Endurant Bifurcated Arm|Endurant Stent Graft System - Endurant Bifurcated arm
522834|NCT00705718|E1|Reported Event|1. Endurant AUI Arm|Endurant Stent Graft System - Endurant AUI arm
522835|NCT00705679|B6|Baseline|Total|Total of all reporting groups
522836|NCT00705679|B5|Baseline|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
522837|NCT00705679|B4|Baseline|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
522838|NCT00705679|B3|Baseline|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522839|NCT00705679|B2|Baseline|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522840|NCT00705679|B1|Baseline|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
522841|NCT00705679|P5|Participant Flow|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
522842|NCT00705679|P4|Participant Flow|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
523786|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
522843|NCT00705679|P3|Participant Flow|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522844|NCT00705679|P2|Participant Flow|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522845|NCT00705679|P1|Participant Flow|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
522846|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
522847|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
522848|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522849|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522850|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
522851|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522852|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522853|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522854|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522855|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522856|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522857|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522858|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
522859|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522860|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
522861|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
522862|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
522863|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
522864|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
522865|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
522866|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
522867|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522868|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522869|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
522870|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
522871|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
522872|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
522873|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
522875|NCT00705679|E4|Reported Event|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
522876|NCT00705679|E3|Reported Event|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522877|NCT00705679|E2|Reported Event|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
522878|NCT00705679|E1|Reported Event|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
522879|NCT00705666|B1|Baseline|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
522880|NCT00705666|P1|Participant Flow|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
522881|NCT00705666|O1|Outcome|PegIntron as Monotherapy or in Combination With Ribavirin|"Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.~The recommended treatment duration was 24 weeks for genotypes 2 and 3 and 48 weeks for genotype 1 according to the French 2002 consensus meeting.~The start and end dates of the treatment were collected in the questionnaire, so the actual treatment duration was calculated for each participant and compared to the theoretical treatment duration reported at Day 0 by the investigators."
522882|NCT00705666|E1|Reported Event|PegIntron as Monotherapy or in Combination With Ribavirin|
522883|NCT00705653|B1|Baseline|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
522884|NCT00705653|P1|Participant Flow|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
522885|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
522886|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
522887|NCT00705653|E1|Reported Event|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
522888|NCT00705614|B3|Baseline|Total|Total of all reporting groups
522889|NCT00705614|B2|Baseline|Standard Therapy Group|The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
522890|NCT00705614|B1|Baseline|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
522891|NCT00705614|P2|Participant Flow|Standard Therapy Group|"Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.~Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter."
522892|NCT00705614|P1|Participant Flow|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
522893|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522894|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522895|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522896|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522897|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522898|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522899|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522900|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522901|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522902|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522903|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522904|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522905|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522906|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522907|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522908|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522909|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522910|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522911|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522912|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522913|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522914|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522915|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522916|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522917|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522918|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522919|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522920|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522921|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522922|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522923|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522924|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522925|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522926|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522927|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522928|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522929|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522930|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522931|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522932|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522933|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522934|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522935|NCT00705614|E3|Reported Event|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
522936|NCT00705614|E2|Reported Event|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
522937|NCT00705614|E1|Reported Event|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
522938|NCT00705575|B3|Baseline|Total|Total of all reporting groups
522939|NCT00705575|B2|Baseline|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
522940|NCT00705575|B1|Baseline|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
522941|NCT00705575|P2|Participant Flow|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
522942|NCT00705575|P1|Participant Flow|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
522943|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
522944|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
522945|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
522946|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
522947|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
522948|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
522949|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
522950|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
522951|NCT00705575|E2|Reported Event|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
522952|NCT00705575|E1|Reported Event|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
522953|NCT00705536|B3|Baseline|Total|Total of all reporting groups
522954|NCT00705536|B2|Baseline|Stage 2: Humulin-R Alone or Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone or 20 U Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
522955|NCT00705536|B1|Baseline|Stage 1: Humalog Alone or Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone or 20 U Humalog + 300 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
522956|NCT00705536|P4|Participant Flow|Stage 2: Humulin-R + rHuPH20 First, Then Humulin-R|Stage 2 of the study. A single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R alone.
522957|NCT00705536|P3|Participant Flow|Stage 2: Humulin-R First, Then Humulin-R + rHuPH20|Stage 2 of the study: A single subcutaneous (SC) injection of 20 units (U) Humulin-R alone on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20).
522958|NCT00705536|P2|Participant Flow|Stage 1: Humalog + rHuPH20 First, Then Humalog|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog alone.
522959|NCT00705536|P1|Participant Flow|Stage 1: Humalog First, Then Humalog + rHuPH20|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog alone on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20).
522960|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522961|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin: A single subcutaneous (SC) injection of 20 units (U)
522962|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522963|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522964|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522965|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522966|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522967|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522968|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522969|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522970|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522972|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522973|NCT00705536|O3|Outcome|Stage 2: Humulin Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522974|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522975|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522976|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522977|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522978|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522979|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522980|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522981|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522982|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522983|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522984|NCT00705536|O2|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humulin-R and 240 U of rHuPH20
522985|NCT00705536|O1|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humalog and 300 U of rHuPH20
522986|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522987|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522988|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522989|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522990|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522991|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522992|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522993|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522994|NCT00705536|O3|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522995|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
522996|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
522997|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
522998|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
522999|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) : A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U rHuPH20
523000|NCT00705536|O1|Outcome|Stage 1. Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
523001|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
523002|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
523003|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
523004|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
523005|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
523006|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
523007|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
523008|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
523009|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
523010|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
523011|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
523012|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
523013|NCT00705536|E4|Reported Event|Stage 2: Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20) during Stage 2 of the study
523787|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523014|NCT00705536|E3|Reported Event|Stage 2: Humulin-R Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone during Stage 2 of the study
523015|NCT00705536|E2|Reported Event|Stage 1: Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase (rHuPH20) during Stage 1 of the study
523016|NCT00705536|E1|Reported Event|Stage 1: Humalog Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone during Stage 1 of the study
523017|NCT00705523|B3|Baseline|Total|Total of all reporting groups
523018|NCT00705523|B2|Baseline|Placebo|placebo : BID 12 weeks
523019|NCT00705523|B1|Baseline|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
523020|NCT00705523|P2|Participant Flow|Placebo|placebo : BID 12 weeks
523021|NCT00705523|P1|Participant Flow|Varenicline|varenicline : 1.0 mg BID for 12 weeks
523022|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
523023|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
523024|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
523025|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
523026|NCT00705523|E2|Reported Event|Placebo|placebo : BID 12 weeks
523027|NCT00705523|E1|Reported Event|Varenicline|varenicline : 1.0 mg BID for 12 weeks
523028|NCT00705432|B7|Baseline|Total|Total of all reporting groups
523029|NCT00705432|B6|Baseline|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523030|NCT00705432|B5|Baseline|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523031|NCT00705432|B4|Baseline|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523032|NCT00705432|B3|Baseline|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523033|NCT00705432|B2|Baseline|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523034|NCT00705432|B1|Baseline|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523035|NCT00705432|P6|Participant Flow|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523036|NCT00705432|P5|Participant Flow|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523037|NCT00705432|P4|Participant Flow|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523038|NCT00705432|P3|Participant Flow|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523039|NCT00705432|P2|Participant Flow|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523121|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523040|NCT00705432|P1|Participant Flow|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523041|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523042|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523043|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523044|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523045|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523046|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523047|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523048|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523049|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523050|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523051|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523052|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523053|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523054|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523055|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523056|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523788|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523057|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523058|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523059|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523060|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523061|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523062|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523063|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523064|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523065|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523066|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523067|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523068|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523069|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523070|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523071|NCT00705432|E3|Reported Event|BOCEPRIVIR + PEG + RBV - 44 WEEKS|Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523122|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523123|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
523124|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
523125|NCT00705367|E2|Reported Event|Placebo|
523126|NCT00705367|E1|Reported Event|Abatacept 30 mg/kg|
523127|NCT00705341|B3|Baseline|Total|Total of all reporting groups
523072|NCT00705432|E2|Reported Event|BOCEPREVIR + PEG + RBV - 24 WEEKS|"Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
523073|NCT00705432|E1|Reported Event|PEG + RBV|Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
523074|NCT00705406|B3|Baseline|Total|Total of all reporting groups
523075|NCT00705406|B2|Baseline|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523076|NCT00705406|B1|Baseline|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523077|NCT00705406|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523078|NCT00705406|P1|Participant Flow|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523079|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523080|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523081|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523082|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523083|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523084|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523085|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523086|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523087|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523088|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523089|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523090|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523091|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection
523092|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523093|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523094|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523095|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523096|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523097|NCT00705406|E2|Reported Event|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
523098|NCT00705406|E1|Reported Event|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
523099|NCT00705367|B3|Baseline|Total|Total of all reporting groups
523100|NCT00705367|B2|Baseline|Placebo|Infusion, Intravenous, single dose, 24 hours
523101|NCT00705367|B1|Baseline|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
523102|NCT00705367|P2|Participant Flow|Placebo/Abatacept,10 mg/kg|Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523103|NCT00705367|P1|Participant Flow|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523104|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523105|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523106|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523107|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523108|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
523109|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
523110|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
523111|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
523112|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
523113|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
523114|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
523128|NCT00705341|B2|Baseline|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
523129|NCT00705341|B1|Baseline|Nonasthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
523130|NCT00705341|P4|Participant Flow|High Dose, Then Low Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.
523131|NCT00705341|P3|Participant Flow|Low Dose, Then High Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
523132|NCT00705341|P2|Participant Flow|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
523133|NCT00705341|P1|Participant Flow|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
523134|NCT00705341|O2|Outcome|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
523135|NCT00705341|O1|Outcome|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
523136|NCT00705341|O2|Outcome|4 Weeks of Low Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily
523137|NCT00705341|O1|Outcome|4 Weeks of High Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
523138|NCT00705341|E2|Reported Event|High Dose for Phase 2|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
523139|NCT00705341|E1|Reported Event|Low Dose for phase1|4 weeks of Fluticasone (Flovent diskus) 250 mcg twice daily (500 mcg/day)
523140|NCT00705289|B1|Baseline|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
523141|NCT00705289|P1|Participant Flow|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
523142|NCT00705289|O4|Outcome|Established RA, Failed/Did Not Tolerate Another Anti-TNF|Subjects with established RA having failed or not tolerated another anti-TNF.
523143|NCT00705289|O3|Outcome|Established RA, Not Treated With Anti-TNF|Subjects with established RA not yet treated with an anti-TNF.
523144|NCT00705289|O2|Outcome|Early RA, Not Treated With Anti-TNF|Subjects with early RA not yet treated with an anti-TNF.
523145|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
523146|NCT00705289|O12|Outcome|Sweden|
523147|NCT00705289|O11|Outcome|Portugal|
523148|NCT00705289|O10|Outcome|Poland|
523149|NCT00705289|O9|Outcome|Norway|
523150|NCT00705289|O8|Outcome|Netherlands|
523151|NCT00705289|O7|Outcome|Italy|
523152|NCT00705289|O6|Outcome|Greece|
523153|NCT00705289|O5|Outcome|Germany|
523154|NCT00705289|O4|Outcome|France|
523155|NCT00705289|O3|Outcome|Denmark|
523156|NCT00705289|O2|Outcome|Belgium|
523157|NCT00705289|O1|Outcome|Austria|
523158|NCT00705289|O3|Outcome|Female|
523159|NCT00705289|O2|Outcome|Male|
523160|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
523161|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
523162|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
523163|NCT00705289|E1|Reported Event|Infliximab 3 mg/kg|
523164|NCT00705263|B1|Baseline|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
523165|NCT00705263|P1|Participant Flow|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
523166|NCT00705263|O1|Outcome|Patients Treated With PegIntron Pen Plus Rebetol|
523167|NCT00705263|E1|Reported Event|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
523168|NCT00705250|B1|Baseline|All Participants|
523169|NCT00705250|P1|Participant Flow|All Participants|Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
523170|NCT00705250|O1|Outcome|All Participants|
523171|NCT00705250|E1|Reported Event|All Participants|
523219|NCT00705146|E1|Reported Event|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
523220|NCT00705107|B1|Baseline|All Treated Patients|
523221|NCT00705107|P1|Participant Flow|All Treated Patients|
523172|NCT00705224|B1|Baseline|Pegylated Interferon and Ribavirin|"Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
523173|NCT00705224|P1|Participant Flow|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C."
523174|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523175|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523176|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523177|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and a stage of hepatitis C.
523178|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523179|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523180|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523222|NCT00705107|O1|Outcome|All Treated Patients|
523223|NCT00705107|O1|Outcome|All Treated Patients|
523224|NCT00705107|E1|Reported Event|All Treated Patients|
523225|NCT00705081|B3|Baseline|Total|Total of all reporting groups
523226|NCT00705081|B2|Baseline|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
523789|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523181|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523182|NCT00705224|O1|Outcome|Pegylated Interferon and Ribavirin|Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
523183|NCT00705224|E1|Reported Event|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
523184|NCT00705159|B5|Baseline|Total|Total of all reporting groups
523185|NCT00705159|B4|Baseline|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
523186|NCT00705159|B3|Baseline|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
523187|NCT00705159|B2|Baseline|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
523188|NCT00705159|B1|Baseline|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
523189|NCT00705159|P4|Participant Flow|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
523190|NCT00705159|P3|Participant Flow|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
523191|NCT00705159|P2|Participant Flow|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
523192|NCT00705159|P1|Participant Flow|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
523193|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
523194|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
523195|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
523196|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
523197|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
523198|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
523199|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
523200|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
523201|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
523202|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
523203|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
523204|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
523205|NCT00705159|E4|Reported Event|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
523206|NCT00705159|E3|Reported Event|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
523207|NCT00705159|E2|Reported Event|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
523208|NCT00705159|E1|Reported Event|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
523209|NCT00705146|B3|Baseline|Total|Total of all reporting groups
523210|NCT00705146|B2|Baseline|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
523211|NCT00705146|B1|Baseline|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
523212|NCT00705146|P2|Participant Flow|Comfort Cool Splint 4 Weeks, 1 Week Washout, Then Hybrid Splin|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
523213|NCT00705146|P1|Participant Flow|Hybrid Splint 4 Weeks, 1 Week Washout, Then Comfort Cool Splin|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
523214|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
523215|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
523216|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
523217|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
523218|NCT00705146|E2|Reported Event|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
523227|NCT00705081|B1|Baseline|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
523228|NCT00705081|P2|Participant Flow|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
523229|NCT00705081|P1|Participant Flow|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
523230|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
523231|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
523232|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
523233|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
523234|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
523235|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
523236|NCT00705081|E2|Reported Event|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
523237|NCT00705081|E1|Reported Event|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
523238|NCT00705016|B4|Baseline|Total|Total of all reporting groups
523239|NCT00705016|B3|Baseline|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523240|NCT00705016|B2|Baseline|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523241|NCT00705016|B1|Baseline|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523242|NCT00705016|P3|Participant Flow|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523243|NCT00705016|P2|Participant Flow|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523244|NCT00705016|P1|Participant Flow|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523302|NCT00704938|P2|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523303|NCT00704938|P1|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523245|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523246|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523247|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523248|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523249|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523250|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523251|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523252|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523253|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523254|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523304|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523790|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523255|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523256|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523257|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523258|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523259|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523260|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523261|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523262|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523263|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523264|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523390|NCT00704522|P1|Participant Flow|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
523265|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523266|NCT00705016|E3|Reported Event|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523267|NCT00705016|E2|Reported Event|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523268|NCT00705016|E1|Reported Event|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
523269|NCT00705003|B4|Baseline|Total|Total of all reporting groups
523270|NCT00705003|B3|Baseline|Placebo|Placebo QD
523271|NCT00705003|B2|Baseline|BCI-024|Buspirone 15 mg QD
523272|NCT00705003|B1|Baseline|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
523273|NCT00705003|P3|Participant Flow|Placebo|Matching placebo QD
523274|NCT00705003|P2|Participant Flow|BCI-024 (Buspirone)|1 over-encapsulated tablet of buspirone 15 mg QD
523275|NCT00705003|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|1 over-encapsulated tablet of buspirone 15 mg and 1 over-encapsulated tablet of melatonin 3 mg QD
523276|NCT00705003|O3|Outcome|Placebo|Placebo QD
523277|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
523278|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
523279|NCT00705003|O3|Outcome|Placebo|Placebo QD
523280|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
523281|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
523282|NCT00705003|O3|Outcome|Placebo|Placebo QD
523283|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
523284|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
523285|NCT00705003|O3|Outcome|Placebo|Placebo QD
523286|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
523287|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
523288|NCT00705003|O3|Outcome|Placebo|Placebo QD
523289|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
523290|NCT00705003|O1|Outcome|BCI-024+BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
523291|NCT00705003|E3|Reported Event|Placebo|Placebo QD
523292|NCT00705003|E2|Reported Event|BCI-024|Buspirone 15 mg QD
523293|NCT00705003|E1|Reported Event|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
523294|NCT00704964|B1|Baseline|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
523295|NCT00704964|P1|Participant Flow|All Participants|"Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.~Completers are considered those with documentation who finished the study on time."
523296|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
523297|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
523298|NCT00704964|E1|Reported Event|All Participants|
523299|NCT00704938|B3|Baseline|Total|Total of all reporting groups
523300|NCT00704938|B2|Baseline|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523301|NCT00704938|B1|Baseline|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
531696|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
523305|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523306|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523307|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523308|NCT00704938|E2|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523309|NCT00704938|E1|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
523310|NCT00704912|B4|Baseline|Total|Total of all reporting groups
523311|NCT00704912|B3|Baseline|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
523312|NCT00704912|B2|Baseline|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
523313|NCT00704912|B1|Baseline|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
523314|NCT00704912|P3|Participant Flow|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
523315|NCT00704912|P2|Participant Flow|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
523316|NCT00704912|P1|Participant Flow|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
523317|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
523318|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
523319|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
523320|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
523321|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
523322|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
523323|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
523324|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
523325|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
523326|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
523327|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
523328|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
523329|NCT00704912|E3|Reported Event|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
523330|NCT00704912|E2|Reported Event|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
523331|NCT00704912|E1|Reported Event|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
523332|NCT00704847|B3|Baseline|Total|Total of all reporting groups
523333|NCT00704847|B2|Baseline|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
523334|NCT00704847|B1|Baseline|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
523335|NCT00704847|P2|Participant Flow|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
523336|NCT00704847|P1|Participant Flow|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
523337|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
523338|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
523339|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
523340|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
523341|NCT00704847|E2|Reported Event|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
523342|NCT00704847|E1|Reported Event|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
523343|NCT00704808|B1|Baseline|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
523464|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523344|NCT00704808|P1|Participant Flow|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
523345|NCT00704808|O1|Outcome|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
523346|NCT00704808|E1|Reported Event|Temozolomide|
523347|NCT00704769|B1|Baseline|Desloratadine|
523348|NCT00704769|P1|Participant Flow|Desloratadine|
523349|NCT00704769|O1|Outcome|Desloratadine|
523350|NCT00704769|O1|Outcome|Desloratadine|
523351|NCT00704769|E1|Reported Event|Desloratadine|
523352|NCT00704730|B3|Baseline|Total|Total of all reporting groups
523353|NCT00704730|B2|Baseline|Placebo|oral capsules once daily
523354|NCT00704730|B1|Baseline|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523355|NCT00704730|P2|Participant Flow|Placebo|oral capsules once daily
523356|NCT00704730|P1|Participant Flow|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523357|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
523358|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523359|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
523360|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523361|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
523362|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523363|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
523364|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523365|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
523366|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523367|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
523368|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
523369|NCT00704730|E2|Reported Event|Placebo|oral capsules once daily
523370|NCT00704730|E1|Reported Event|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
523371|NCT00704717|B1|Baseline|All Treated Patients|All patients participating in the study.
523372|NCT00704717|P1|Participant Flow|All Treated Patients|All patients participating in the study.
523373|NCT00704717|O1|Outcome|All Treated Patients|All patients participating in the study.
523374|NCT00704717|E1|Reported Event|All Treated Patients|All patients participating in the study.
523375|NCT00704535|B1|Baseline|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523376|NCT00704535|P1|Participant Flow|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523377|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523378|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523379|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523380|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523381|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523382|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523383|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523384|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523385|NCT00704535|E1|Reported Event|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
523386|NCT00704522|B3|Baseline|Total|Total of all reporting groups
523387|NCT00704522|B2|Baseline|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
523388|NCT00704522|B1|Baseline|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
523389|NCT00704522|P2|Participant Flow|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
523791|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
531697|NCT00684307|O5|Outcome|VKA INR 2-3|
523391|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
523392|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
523393|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
523394|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
523395|NCT00704522|E1|Reported Event|PegIntron Pen/Rebetol|
523396|NCT00704496|B3|Baseline|Total|Total of all reporting groups
523397|NCT00704496|B2|Baseline|Pseudoephedrine|"Pseudoephedrine is a 240 mg PO per day~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523398|NCT00704496|B1|Baseline|Placebo|"Placebo~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523399|NCT00704496|P2|Participant Flow|Placebo|Placebo arm
523400|NCT00704496|P1|Participant Flow|Pseudoephedrine|Pseudoephedrine is a 240 mg PO per day
523401|NCT00704496|O2|Outcome|Pseudoephedrine|"Pseudoephedrine is a 240 mg PO per day~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523402|NCT00704496|O1|Outcome|Placebo|"Placebo~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523403|NCT00704496|O2|Outcome|Pseudoephedrine|"Pseudoephedrine is a 240 mg PO per day~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523404|NCT00704496|O1|Outcome|Placebo|"Placebo~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523405|NCT00704496|E2|Reported Event|Pseudoephedrine|"Pseudoephedrine is a 240 mg PO per day~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523406|NCT00704496|E1|Reported Event|Placebo|"Placebo~Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day"
523407|NCT00704418|B3|Baseline|Total|Total of all reporting groups
523408|NCT00704418|B2|Baseline|Placebo|Placebo, dosed 1 drop daily
523409|NCT00704418|B1|Baseline|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
523410|NCT00704418|P2|Participant Flow|Placebo|Placebo, dosed 1 drop daily
523411|NCT00704418|P1|Participant Flow|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
523412|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
523413|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
523414|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
523415|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
523416|NCT00704418|E2|Reported Event|Placebo|Placebo, dosed 1 drop daily
523417|NCT00704418|E1|Reported Event|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
523418|NCT00704405|B6|Baseline|Total|Total of all reporting groups
523419|NCT00704405|B5|Baseline|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523420|NCT00704405|B4|Baseline|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
523421|NCT00704405|B3|Baseline|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
523422|NCT00704405|B2|Baseline|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
523423|NCT00704405|B1|Baseline|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
523424|NCT00704405|P5|Participant Flow|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523425|NCT00704405|P4|Participant Flow|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
523426|NCT00704405|P3|Participant Flow|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
523427|NCT00704405|P2|Participant Flow|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
523428|NCT00704405|P1|Participant Flow|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
523429|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523430|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
523431|NCT00704405|O3|Outcome|PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523792|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523432|NCT00704405|O2|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523433|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
523434|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523435|NCT00704405|O1|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523436|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523437|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523438|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523439|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
523440|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
523441|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523442|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523443|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523444|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
523445|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
523446|NCT00704405|O4|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523447|NCT00704405|O3|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523448|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
523449|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
523450|NCT00704405|E5|Reported Event|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
523451|NCT00704405|E4|Reported Event|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
523452|NCT00704405|E3|Reported Event|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
523453|NCT00704405|E2|Reported Event|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
523454|NCT00704405|E1|Reported Event|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
523455|NCT00704379|B3|Baseline|Total|Total of all reporting groups
523456|NCT00704379|B2|Baseline|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523457|NCT00704379|B1|Baseline|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523458|NCT00704379|P2|Participant Flow|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523459|NCT00704379|P1|Participant Flow|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523460|NCT00704379|O2|Outcome|Patients Who Did Not Developped a Mood or Anxiety Disorder|
523461|NCT00704379|O1|Outcome|Patients Who Developped a Mood or Anxiety Disorder|
523462|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523463|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523465|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523466|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523467|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523468|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523469|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523470|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523471|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523472|NCT00704379|E2|Reported Event|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
523473|NCT00704379|E1|Reported Event|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
523474|NCT00704353|B3|Baseline|Total|Total of all reporting groups
523475|NCT00704353|B2|Baseline|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
523476|NCT00704353|B1|Baseline|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
523477|NCT00704353|P2|Participant Flow|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
523478|NCT00704353|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
523479|NCT00704353|O2|Outcome|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
523480|NCT00704353|O1|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
523481|NCT00704353|E2|Reported Event|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
523482|NCT00704353|E1|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
523483|NCT00704340|B3|Baseline|Total|Total of all reporting groups
523484|NCT00704340|B2|Baseline|Control|Standard of Care (control)
523485|NCT00704340|B1|Baseline|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
523486|NCT00704340|P2|Participant Flow|Control|Standard of Care (control)
523487|NCT00704340|P1|Participant Flow|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
523488|NCT00704340|O2|Outcome|Control|Standard of Care (control)
523489|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
523490|NCT00704340|O2|Outcome|Control|Standard of Care (control)
523491|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
523492|NCT00704340|O2|Outcome|Control|Standard of Care (control)
523493|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
523494|NCT00704340|E2|Reported Event|Control|Standard of Care (control)
523495|NCT00704340|E1|Reported Event|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
523496|NCT00704184|B6|Baseline|Total|Total of all reporting groups
523497|NCT00704184|B5|Baseline|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523498|NCT00704184|B4|Baseline|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523499|NCT00704184|B3|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523500|NCT00704184|B2|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523501|NCT00704184|B1|Baseline|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523502|NCT00704184|P5|Participant Flow|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523503|NCT00704184|P4|Participant Flow|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523504|NCT00704184|P3|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523505|NCT00704184|P2|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523506|NCT00704184|P1|Participant Flow|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523507|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523508|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523509|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523510|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523511|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523512|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523513|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523514|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523515|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523516|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523517|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523518|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523519|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523520|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523521|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523522|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523523|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523524|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523525|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523526|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523527|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523528|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523529|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523530|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523531|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523532|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523533|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523534|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523535|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523536|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523537|NCT00704184|E5|Reported Event|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523538|NCT00704184|E4|Reported Event|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523539|NCT00704184|E3|Reported Event|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523540|NCT00704184|E2|Reported Event|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523541|NCT00704184|E1|Reported Event|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
523542|NCT00704171|B3|Baseline|Total|Total of all reporting groups
523543|NCT00704171|B2|Baseline|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523544|NCT00704171|B1|Baseline|PleuraSeal|PleuraSeal Lung Sealant System
523545|NCT00704171|P2|Participant Flow|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523546|NCT00704171|P1|Participant Flow|PleuraSeal|PleuraSeal Lung Sealant System
523547|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523548|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
523549|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523550|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
523551|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523552|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
523553|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523554|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
523555|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523556|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
523557|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523558|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
523559|NCT00704171|E2|Reported Event|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
523560|NCT00704171|E1|Reported Event|PleuraSeal|PleuraSeal Lung Sealant System
523561|NCT00704132|B3|Baseline|Total|Total of all reporting groups
523562|NCT00704132|B2|Baseline|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
523563|NCT00704132|B1|Baseline|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
523564|NCT00704132|P2|Participant Flow|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
523565|NCT00704132|P1|Participant Flow|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
523566|NCT00704132|O2|Outcome|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
523567|NCT00704132|O1|Outcome|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
523568|NCT00704132|E2|Reported Event|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
523569|NCT00704132|E1|Reported Event|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
523570|NCT00704028|B3|Baseline|Total|Total of all reporting groups
523571|NCT00704028|B2|Baseline|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
523572|NCT00704028|B1|Baseline|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
523573|NCT00704028|P2|Participant Flow|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
523574|NCT00704028|P1|Participant Flow|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
523575|NCT00704028|O2|Outcome|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
523576|NCT00704028|O1|Outcome|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
523577|NCT00704028|E2|Reported Event|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
523578|NCT00704028|E1|Reported Event|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
523579|NCT00703976|B3|Baseline|Total|Total of all reporting groups
523580|NCT00703976|B2|Baseline|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
523581|NCT00703976|B1|Baseline|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
523598|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
523582|NCT00703976|P2|Participant Flow|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
523583|NCT00703976|P1|Participant Flow|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
523584|NCT00703976|O3|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
523585|NCT00703976|O2|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
523586|NCT00703976|O1|Outcome|All Participants (Overall Study)|
523587|NCT00703976|O2|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
523588|NCT00703976|O1|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
523589|NCT00703976|E1|Reported Event|All Participants (Overall Study)|
523590|NCT00703963|B3|Baseline|Total|Total of all reporting groups
523591|NCT00703963|B2|Baseline|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
523592|NCT00703963|B1|Baseline|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
523593|NCT00703963|P2|Participant Flow|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
523594|NCT00703963|P1|Participant Flow|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
523595|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
523596|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
523597|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
523680|NCT00703820|B1|Baseline|Cytarabine+Daunorubicin+Etoposide|Participants receive Cytarabine + Daunorubicin + Etoposide as a first course followed by risk-adapted therapy.
523599|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
523600|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
523601|NCT00703963|E2|Reported Event|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
523602|NCT00703963|E1|Reported Event|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
523603|NCT00703937|B3|Baseline|Total|Total of all reporting groups
523604|NCT00703937|B2|Baseline|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
523605|NCT00703937|B1|Baseline|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
523606|NCT00703937|P2|Participant Flow|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
523607|NCT00703937|P1|Participant Flow|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
523608|NCT00703937|O2|Outcome|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
523609|NCT00703937|O1|Outcome|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
523610|NCT00703937|E2|Reported Event|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
523611|NCT00703937|E1|Reported Event|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
523612|NCT00703924|B3|Baseline|Total|Total of all reporting groups
523613|NCT00703924|B2|Baseline|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
523614|NCT00703924|B1|Baseline|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
523615|NCT00703924|P2|Participant Flow|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
523616|NCT00703924|P1|Participant Flow|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
523617|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
523618|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
523619|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
523620|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
523621|NCT00703924|O4|Outcome|Day 180 (+7 Days)|100% Re-epithelialization by day 180 (+7 days)
523622|NCT00703924|O3|Outcome|Day 100|100% Re-epithelialization by day 100
523623|NCT00703924|O2|Outcome|Day 50|100% Re-epithelialization by day 50
523624|NCT00703924|O1|Outcome|Day 20|100% Re-epithelialization by day 20
523625|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
523626|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
523627|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
523628|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
523629|NCT00703924|E2|Reported Event|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
523630|NCT00703924|E1|Reported Event|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
523793|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523631|NCT00703911|B1|Baseline|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523632|NCT00703911|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523633|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523634|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523635|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523636|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523637|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523638|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523639|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523640|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523641|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523642|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523643|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523644|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523645|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523646|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523647|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523648|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523649|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523650|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523651|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523652|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523653|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523654|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523655|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523656|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523657|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523658|NCT00703911|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
523659|NCT00703885|B1|Baseline|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Please note that this is a cross-over design with all subjects receiving all three treatments"
523660|NCT00703885|P1|Participant Flow|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Sequence of administration not available for subjects"
523661|NCT00703885|O1|Outcome|Imaging Data for Repeated Measures|"Crossover design. Each subject receives, in randomized order and on different days:~Low dose alprazolam High dose alprazolam Placebo"
523662|NCT00703885|O1|Outcome|BOLD fMRI|Cross-over design. Each subject receives, on alternate days and in randomized fashion, either low dose, high dose, or placebo
523663|NCT00703885|E1|Reported Event|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|Alprazolam Low Dose Alprazolam High Dose Placebo
523664|NCT00703846|B1|Baseline|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523665|NCT00703846|P1|Participant Flow|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. The maximum treatment period was 12 months.
523666|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523667|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523668|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523669|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523670|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523671|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523672|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523673|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523674|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523675|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523676|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523677|NCT00703846|E1|Reported Event|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
523678|NCT00703820|B3|Baseline|Total|Total of all reporting groups
523679|NCT00703820|B2|Baseline|Clofarabine+Cytarabine|Participants receive Clofarabine + Cytarabine as a first course followed by risk-adapted therapy.
523794|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523681|NCT00703820|P2|Participant Flow|Clofarabine+Cytarabine|Participants receive Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
523682|NCT00703820|P1|Participant Flow|Cytarabine+Daunorubicin+Etoposide|Participants receive Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
523683|NCT00703820|O2|Outcome|Clofarabine+Cytarabine|Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
523684|NCT00703820|O1|Outcome|Cytarabine+Daunorubicin+Etoposide|Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
523685|NCT00703820|E3|Reported Event|Stem Cell Donors|This group enrolled in the study to provide donor cells to participants. Donors did not receive therapy.
523686|NCT00703820|E2|Reported Event|Clofarabine+Cytarabine|Participants received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
523687|NCT00703820|E1|Reported Event|Cytarabine+Daunorubicin+Etoposide|Participants received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
523688|NCT00703781|B3|Baseline|Total|Total of all reporting groups
523689|NCT00703781|B2|Baseline|Placebo|Placebo, Dosed 1 Drop Daily
523690|NCT00703781|B1|Baseline|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
523691|NCT00703781|P2|Participant Flow|Placebo|Placebo, Dosed 1 Drop Daily
523692|NCT00703781|P1|Participant Flow|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
523693|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
523694|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
523695|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
523696|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
523697|NCT00703781|E2|Reported Event|Placebo|Placebo, Dosed 1 Drop Daily
523698|NCT00703781|E1|Reported Event|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
523699|NCT00703729|B3|Baseline|Total|Total of all reporting groups
523700|NCT00703729|B2|Baseline|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523701|NCT00703729|B1|Baseline|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523702|NCT00703729|P2|Participant Flow|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523703|NCT00703729|P1|Participant Flow|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523704|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523705|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523736|NCT00703677|B1|Baseline|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523795|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523706|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523707|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523708|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523709|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523710|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523711|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523712|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523713|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523714|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523715|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523716|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523717|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523718|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523719|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523720|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523721|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523722|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523723|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523724|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523725|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523726|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523727|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523728|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523729|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523730|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523731|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523732|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523733|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523734|NCT00703729|E2|Reported Event|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523735|NCT00703729|E1|Reported Event|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
523737|NCT00703677|P1|Participant Flow|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523738|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523739|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523740|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523741|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523742|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523743|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523744|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523745|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523746|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523747|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523748|NCT00703677|E1|Reported Event|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
523749|NCT00703534|B3|Baseline|Total|Total of all reporting groups
523750|NCT00703534|B2|Baseline|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
523751|NCT00703534|B1|Baseline|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
523752|NCT00703534|P2|Participant Flow|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
523753|NCT00703534|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
523754|NCT00703534|O2|Outcome|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
523755|NCT00703534|O1|Outcome|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
523756|NCT00703534|E2|Reported Event|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
523757|NCT00703534|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
523758|NCT00703508|B1|Baseline|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
523759|NCT00703508|P1|Participant Flow|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
523760|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523761|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523762|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523763|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523764|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523765|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523766|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523767|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523768|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
523769|NCT00703508|E1|Reported Event|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
523770|NCT00703391|B3|Baseline|Total|Total of all reporting groups
523771|NCT00703391|B2|Baseline|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523772|NCT00703391|B1|Baseline|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523773|NCT00703391|P2|Participant Flow|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523774|NCT00703391|P1|Participant Flow|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523775|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523776|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523777|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523778|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523779|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523780|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523781|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523782|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523796|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523797|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523798|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523799|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523800|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523801|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523802|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523803|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523804|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523805|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523806|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523807|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523808|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523809|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523810|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523811|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523812|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523813|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523814|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523815|NCT00703391|E2|Reported Event|Placebo|Matched placebo tablets twice daily (bid) for 14 days
523816|NCT00703391|E1|Reported Event|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
523817|NCT00703339|B1|Baseline|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
523818|NCT00703339|P1|Participant Flow|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
523819|NCT00703339|O1|Outcome|18mcg Inhaled Treprostinil Cohort|Number of participates on a dose of three 6mcg breaths (18mcg total)with Adverse Events
523820|NCT00703339|O1|Outcome|18mcg Inhaled Treprostinil Cohort|Number of participates on a dose of three 6mcg breaths (18mcg total)with Adverse Events
523821|NCT00703339|E1|Reported Event|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
523822|NCT00703326|B3|Baseline|Total|Total of all reporting groups
523823|NCT00703326|B2|Baseline|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523824|NCT00703326|B1|Baseline|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523825|NCT00703326|P2|Participant Flow|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523826|NCT00703326|P1|Participant Flow|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523827|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day~1 of each 21-day cycle."
523828|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523829|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523830|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523861|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
523831|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523832|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523833|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523834|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523835|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523836|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523837|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523838|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523839|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523840|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523841|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523842|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523843|NCT00703326|E2|Reported Event|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523844|NCT00703326|E1|Reported Event|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
523845|NCT00703261|B3|Baseline|Total|Total of all reporting groups
523846|NCT00703261|B2|Baseline|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
523847|NCT00703261|B1|Baseline|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
523848|NCT00703261|P2|Participant Flow|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
523849|NCT00703261|P1|Participant Flow|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
523850|NCT00703261|O1|Outcome|Statin-Naive Participants|Participants self-administered one 10 mg or 80 mg atorvastatin tablet and one matching 80 mg or 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
523851|NCT00703261|O2|Outcome|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
523852|NCT00703261|O1|Outcome|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.
523853|NCT00703261|E2|Reported Event|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
523854|NCT00703261|E1|Reported Event|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
523855|NCT00703157|B3|Baseline|Total|Total of all reporting groups
523856|NCT00703157|B2|Baseline|Surgery|Surgical Ablation
523857|NCT00703157|B1|Baseline|Catheter|Catheter Ablation
523858|NCT00703157|P2|Participant Flow|Surgery|Surgical Ablation
523859|NCT00703157|P1|Participant Flow|Catheter|Catheter Ablation
523860|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
523874|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
523875|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
523876|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
523877|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
523878|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
523879|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
523880|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
523881|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
523882|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
523883|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
523884|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
523885|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
523886|NCT00703157|E3|Reported Event|All Randomized Subjects|All Randomized Subjects, regardless of randomization group
523887|NCT00703157|E2|Reported Event|Surgery|Surgical Ablation
523888|NCT00703157|E1|Reported Event|Catheter|Catheter Ablation
523889|NCT00703118|B4|Baseline|Total|Total of all reporting groups
523890|NCT00703118|B3|Baseline|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523891|NCT00703118|B2|Baseline|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523892|NCT00703118|B1|Baseline|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523893|NCT00703118|P3|Participant Flow|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523894|NCT00703118|P2|Participant Flow|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523895|NCT00703118|P1|Participant Flow|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523896|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523897|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523898|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523899|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523900|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523901|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523902|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523903|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523904|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523905|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523906|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523907|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523908|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523909|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523910|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523911|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523912|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523913|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523914|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523915|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523916|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523917|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523918|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
523919|NCT00703118|E6|Reported Event|Pbo/PR48 - OVERALL TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
523920|NCT00703118|E5|Reported Event|T12(DS)/PR48 - OVERALL TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
523921|NCT00703118|E4|Reported Event|T12/PR48 - OVERALL TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
531698|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
523922|NCT00703118|E3|Reported Event|Pbo/PR48 - TVR/PBO TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
523923|NCT00703118|E2|Reported Event|T12(DS)/PR48 - TVR/PBO TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
523924|NCT00703118|E1|Reported Event|T12/PR48 - TVR/PBO TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
523925|NCT00703092|B1|Baseline|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
523926|NCT00703092|P1|Participant Flow|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
523927|NCT00703092|O1|Outcome|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
523928|NCT00703092|O1|Outcome|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
523929|NCT00703092|E1|Reported Event|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
523930|NCT00703053|B10|Baseline|Total|Total of all reporting groups
523931|NCT00703053|B9|Baseline|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523932|NCT00703053|B8|Baseline|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523933|NCT00703053|B7|Baseline|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523934|NCT00703053|B6|Baseline|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523935|NCT00703053|B5|Baseline|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
523936|NCT00703053|B4|Baseline|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523937|NCT00703053|B3|Baseline|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523938|NCT00703053|B2|Baseline|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523939|NCT00703053|B1|Baseline|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523940|NCT00703053|P9|Participant Flow|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523941|NCT00703053|P8|Participant Flow|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523942|NCT00703053|P7|Participant Flow|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523943|NCT00703053|P6|Participant Flow|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523944|NCT00703053|P5|Participant Flow|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
523945|NCT00703053|P4|Participant Flow|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523946|NCT00703053|P3|Participant Flow|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523947|NCT00703053|P2|Participant Flow|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523948|NCT00703053|P1|Participant Flow|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523949|NCT00703053|O3|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523950|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524171|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
523951|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523952|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523953|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523954|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523955|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523956|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
523957|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523958|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523959|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523960|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523961|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523962|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523963|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523964|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523965|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
523966|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523967|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523968|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523969|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523970|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523971|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523972|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523973|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523974|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
523975|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523976|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523977|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523978|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523979|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523980|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523981|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523982|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523983|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
523984|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523985|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523986|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523987|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523988|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523989|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523990|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523991|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523992|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
523993|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523994|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
523995|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523996|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523997|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523998|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
523999|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524000|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524001|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524002|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524003|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524004|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524005|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524006|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524007|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524008|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524009|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524010|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524011|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524012|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524013|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524014|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524015|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524016|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524017|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524018|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524019|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524020|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524021|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524022|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524023|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524024|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524025|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524026|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524027|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524028|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524029|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524030|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524031|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524032|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524033|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524034|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524035|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524036|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524037|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524038|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524039|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524040|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524041|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524042|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524043|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524044|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524045|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524046|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524047|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524048|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524049|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524050|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524051|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524052|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524053|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524054|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524144|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
524055|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524056|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524057|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524058|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524059|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524060|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524061|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524062|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524063|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524064|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524065|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524066|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524067|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524068|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524069|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524070|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524071|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524072|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524073|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524074|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524075|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524076|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524077|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524078|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524079|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524080|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524081|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524082|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524083|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524084|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524085|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524086|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524087|NCT00703053|O8|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524088|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524089|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524090|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524091|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524092|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524093|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524094|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524095|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524096|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524097|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524098|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524099|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524100|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524101|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524102|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524103|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524104|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524105|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524145|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
524106|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524107|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524108|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524109|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524110|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524111|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524112|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524113|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524114|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524115|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524116|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524117|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524118|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524119|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524120|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524121|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524122|NCT00703053|E9|Reported Event|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524123|NCT00703053|E8|Reported Event|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524124|NCT00703053|E7|Reported Event|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524125|NCT00703053|E6|Reported Event|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524126|NCT00703053|E5|Reported Event|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
524127|NCT00703053|E4|Reported Event|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524128|NCT00703053|E3|Reported Event|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
524129|NCT00703053|E2|Reported Event|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524130|NCT00703053|E1|Reported Event|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
524131|NCT00703014|B3|Baseline|Total|Total of all reporting groups
524132|NCT00703014|B2|Baseline|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524133|NCT00703014|B1|Baseline|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524134|NCT00703014|P4|Participant Flow|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
524135|NCT00703014|P3|Participant Flow|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
524136|NCT00703014|P2|Participant Flow|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524137|NCT00703014|P1|Participant Flow|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524138|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524139|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524140|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524141|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524142|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
524143|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
524146|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524147|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524148|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524149|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524150|NCT00703014|E4|Reported Event|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
524151|NCT00703014|E3|Reported Event|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
524152|NCT00703014|E2|Reported Event|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524153|NCT00703014|E1|Reported Event|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
524154|NCT00702949|B4|Baseline|Total|Total of all reporting groups
524155|NCT00702949|B3|Baseline|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524156|NCT00702949|B2|Baseline|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524157|NCT00702949|B1|Baseline|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524158|NCT00702949|P3|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524159|NCT00702949|P2|Participant Flow|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524160|NCT00702949|P1|Participant Flow|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524161|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524162|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524163|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524164|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524165|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524166|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524167|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524168|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524169|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524170|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524256|NCT00702780|E1|Reported Event|Escitalopram|Escitalopram 20mg qd
524172|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524173|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524174|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524175|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524176|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524177|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524178|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524179|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524180|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524181|NCT00702949|E3|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 weeks.
524182|NCT00702949|E2|Reported Event|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
524183|NCT00702949|E1|Reported Event|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
524184|NCT00702923|B1|Baseline|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
524185|NCT00702923|P1|Participant Flow|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
524186|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
524187|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
524188|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
524189|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
524190|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
524191|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
524192|NCT00702923|E1|Reported Event|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
524193|NCT00702884|B1|Baseline|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524194|NCT00702884|P1|Participant Flow|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524195|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524196|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524197|NCT00702884|O3|Outcome|Grade 4 Adverse Events|Grade 4=Life-threatening consequences; urgent intervention indicated
524198|NCT00702884|O2|Outcome|Grade 3 Adverse Events|Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated
524199|NCT00702884|O1|Outcome|Grade 1 and 2 Adverse Events|"Grade 1=Mild; asymptomatic or mild symptoms~Grade 2=Moderate; minimal, local or noninvasive intervention indicated"
524200|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524201|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524202|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524203|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524204|NCT00702884|E1|Reported Event|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
524205|NCT00702845|B3|Baseline|Total|Total of all reporting groups
524206|NCT00702845|B2|Baseline|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524207|NCT00702845|B1|Baseline|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524257|NCT00702754|B1|Baseline|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524513|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524208|NCT00702845|P2|Participant Flow|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524209|NCT00702845|P1|Participant Flow|100 μg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
524210|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524211|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524212|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524213|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524214|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524215|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524216|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524258|NCT00702754|P1|Participant Flow|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524259|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524260|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524217|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524218|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524219|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524220|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524221|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524222|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524223|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524224|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524225|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524226|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524514|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524227|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524228|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524229|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524230|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524231|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524232|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524233|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524234|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524235|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524236|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524515|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524237|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524238|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524239|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524240|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524241|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524242|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524243|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524244|NCT00702845|E2|Reported Event|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
524245|NCT00702845|E1|Reported Event|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
524246|NCT00702780|B3|Baseline|Total|Total of all reporting groups
524247|NCT00702780|B2|Baseline|Placebo|placebo 20mg qd
524248|NCT00702780|B1|Baseline|Escitalopram|escitalopram 20mg qd
524249|NCT00702780|P2|Participant Flow|Placebo|placebo 20mg qd
524250|NCT00702780|P1|Participant Flow|Escitalopram|escitalopram 20mg qd
524251|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
524252|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
524253|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
524254|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
524255|NCT00702780|E2|Reported Event|Placebo|Placebo 20mg qd
524261|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524262|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524263|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524264|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524265|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524266|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524267|NCT00702754|E1|Reported Event|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
524268|NCT00702715|B3|Baseline|Total|Total of all reporting groups
524269|NCT00702715|B2|Baseline|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
524270|NCT00702715|B1|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
524271|NCT00702715|P2|Participant Flow|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
524272|NCT00702715|P1|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 post-tetanic counts (PTC). Severe renal impairment was defined as creatinine clearance <30mL/min.
524273|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
524274|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
524275|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
524276|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
524277|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
524278|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
524279|NCT00702715|E2|Reported Event|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
524280|NCT00702715|E1|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
524281|NCT00702702|B4|Baseline|Total|Total of all reporting groups
524282|NCT00702702|B3|Baseline|Placebo|Placebo, 2 placebo capsules daily for 3 months
524283|NCT00702702|B2|Baseline|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
524284|NCT00702702|B1|Baseline|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
524285|NCT00702702|P1|Participant Flow|All Groups|Proellex 25 mg, 50 mg or placebo
524286|NCT00702702|O3|Outcome|Placebo|Placebo, 2 placebo capsules daily for 3 months
524287|NCT00702702|O2|Outcome|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
524288|NCT00702702|O1|Outcome|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
524289|NCT00702702|E3|Reported Event|C Placebo|Placebo, 2 capsules daily for 3 months
524290|NCT00702702|E2|Reported Event|B 50 mg|Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
524291|NCT00702702|E1|Reported Event|A 25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
524292|NCT00702689|B1|Baseline|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524293|NCT00702689|P1|Participant Flow|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524516|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524294|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524295|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524296|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524297|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524298|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524299|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524300|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524301|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524302|NCT00702689|E1|Reported Event|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
524303|NCT00702650|B1|Baseline|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524304|NCT00702650|P1|Participant Flow|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524305|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524306|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524307|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524308|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524309|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524310|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524311|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524312|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524313|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524314|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524315|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524316|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524317|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524318|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524319|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524320|NCT00702650|E1|Reported Event|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
524321|NCT00702624|B3|Baseline|Total|Total of all reporting groups
524376|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
524517|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524518|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524322|NCT00702624|B2|Baseline|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
524323|NCT00702624|B1|Baseline|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
524324|NCT00702624|P4|Participant Flow|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
524325|NCT00702624|P3|Participant Flow|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
524326|NCT00702624|P2|Participant Flow|recFSH 150 IU Women/Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
524327|NCT00702624|P1|Participant Flow|Corifollitropin Alfa 100 μg Women/Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
524328|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
524329|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
524330|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
524331|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
524332|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
524333|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
524519|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
531699|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
524334|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
524335|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
524336|NCT00702624|O2|Outcome|recFSH 150 IU Women|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
524337|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Women|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
524338|NCT00702624|E4|Reported Event|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
524339|NCT00702624|E3|Reported Event|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
524340|NCT00702624|E2|Reported Event|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
524341|NCT00702624|E1|Reported Event|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
524342|NCT00702546|B3|Baseline|Total|Total of all reporting groups
524343|NCT00702546|B2|Baseline|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524377|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
525510|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
524344|NCT00702546|B1|Baseline|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524345|NCT00702546|P2|Participant Flow|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524346|NCT00702546|P1|Participant Flow|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524347|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524348|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524349|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524350|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524351|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524352|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524353|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524354|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524355|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524356|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524357|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524358|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524359|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524508|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
531700|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
524360|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524361|NCT00702546|E2|Reported Event|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524362|NCT00702546|E1|Reported Event|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
524363|NCT00702520|B3|Baseline|Total|Total of all reporting groups
524364|NCT00702520|B2|Baseline|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
524365|NCT00702520|B1|Baseline|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
524366|NCT00702520|P4|Participant Flow|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
524367|NCT00702520|P3|Participant Flow|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
524368|NCT00702520|P2|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
524369|NCT00702520|P1|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
524370|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
524371|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
524372|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
524373|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
524374|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
524375|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
524509|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524378|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
524379|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
524380|NCT00702520|E4|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug|Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
524381|NCT00702520|E3|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug|Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
524382|NCT00702520|E2|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
524383|NCT00702520|E1|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520).
524384|NCT00702507|B1|Baseline|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524385|NCT00702507|P1|Participant Flow|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524386|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524387|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524388|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524389|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524390|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524391|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524392|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524393|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
524394|NCT00702507|E2|Reported Event|Vusion Follow-up Phase|After the Initial Treatment Phase participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment containing 0.25 percent miconazole nitrate.
524395|NCT00702507|E1|Reported Event|Vusion Initial Treatment Phase|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14.
524396|NCT00702468|B3|Baseline|Total|Total of all reporting groups
524397|NCT00702468|B2|Baseline|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
531701|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
524398|NCT00702468|B1|Baseline|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524399|NCT00702468|P2|Participant Flow|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524400|NCT00702468|P1|Participant Flow|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524401|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524402|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524403|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524404|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524405|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524406|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524407|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524408|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524409|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524410|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524411|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524412|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524413|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524414|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524415|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524416|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524417|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524418|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524419|NCT00702468|E2|Reported Event|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
524420|NCT00702468|E1|Reported Event|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
524421|NCT00702403|B1|Baseline|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
524510|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524511|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524422|NCT00702403|P1|Participant Flow|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
524423|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
524424|NCT00702403|O1|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood counts recover (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood counts recover until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
524425|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|"Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.~nilotinib: Given PO~imatinib mesylate: Given PO~pharmacological study: Correlative studies"
524426|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
524427|NCT00702403|O1|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
524428|NCT00702403|E1|Reported Event|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
524429|NCT00702377|B3|Baseline|Total|Total of all reporting groups
524430|NCT00702377|B2|Baseline|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524431|NCT00702377|B1|Baseline|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524432|NCT00702377|P2|Participant Flow|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524433|NCT00702377|P1|Participant Flow|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524434|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524435|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524436|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524437|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524438|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524439|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524440|NCT00702377|E2|Reported Event|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524441|NCT00702377|E1|Reported Event|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
524442|NCT00702364|B3|Baseline|Total|Total of all reporting groups
524443|NCT00702364|B2|Baseline|Placebo|"Placebo twice a day for two weeks~placebo :"
524444|NCT00702364|B1|Baseline|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
524445|NCT00702364|P2|Participant Flow|Placebo|"Placebo twice a day for two weeks~placebo :"
524446|NCT00702364|P1|Participant Flow|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
524447|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
524448|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
524449|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
524450|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
524451|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
524452|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
524453|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
524454|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
524455|NCT00702364|E2|Reported Event|Placebo|"Placebo twice a day for two weeks~placebo :"
524456|NCT00702364|E1|Reported Event|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
524512|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
525511|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
524457|NCT00702338|B1|Baseline|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
524458|NCT00702338|P3|Participant Flow|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
524459|NCT00702338|P2|Participant Flow|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
524460|NCT00702338|P1|Participant Flow|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
524461|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers from study P05693 (NCT00697255) were followed for safety and efficacy on the current study according to standard practice.
524462|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
524463|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
524464|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
524465|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
524466|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
524467|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
524468|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
525512|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
524469|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
524470|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
524471|NCT00702338|E2|Reported Event|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
524472|NCT00702338|E1|Reported Event|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
524473|NCT00702325|B3|Baseline|Total|Total of all reporting groups
524474|NCT00702325|B2|Baseline|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524475|NCT00702325|B1|Baseline|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524476|NCT00702325|P2|Participant Flow|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524477|NCT00702325|P1|Participant Flow|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524478|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524479|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524480|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524481|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524482|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524483|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524484|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524485|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524486|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524487|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524488|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524489|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524490|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524491|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524492|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524493|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524494|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524495|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524496|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524497|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524498|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524499|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524500|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524501|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524502|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524503|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524504|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524505|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524506|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524507|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524520|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524521|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524522|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524523|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524524|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524525|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524526|NCT00702325|E2|Reported Event|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
524527|NCT00702325|E1|Reported Event|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
524528|NCT00702299|B1|Baseline|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524529|NCT00702299|P1|Participant Flow|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524530|NCT00702299|O3|Outcome|Pemetrexed Dose 1,000mg/m2|Level 5 Pemetrexed dose 1,000mg/m2
524531|NCT00702299|O2|Outcome|Pemetrexed Dose 750 mg/m2|Level 4 Pemetrexed dose 750 mg/m2
524532|NCT00702299|O1|Outcome|Pemetrexed Dose 500mg/m2|Level 3 Pemetrexed dose 500mg/m2
524533|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524534|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524535|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524536|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524537|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524538|NCT00702299|E1|Reported Event|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
524539|NCT00702273|B3|Baseline|Total|Total of all reporting groups
524540|NCT00702273|B2|Baseline|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524541|NCT00702273|B1|Baseline|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524542|NCT00702273|P2|Participant Flow|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524543|NCT00702273|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent frozen thawed embryo transfer (FTET) cycles.
524544|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524545|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524546|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524547|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524548|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524549|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524550|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524551|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524552|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524553|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524563|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
524554|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524555|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524556|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524557|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524558|NCT00702273|E2|Reported Event|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524559|NCT00702273|E1|Reported Event|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
524560|NCT00702234|B1|Baseline|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
524561|NCT00702234|P2|Participant Flow|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
524562|NCT00702234|P1|Participant Flow|Women/Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
524580|NCT00702208|P1|Participant Flow|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
531702|NCT00684307|O5|Outcome|VKA INR 2-3|
524564|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
524565|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
524566|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
524567|NCT00702234|O1|Outcome|Women - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
524568|NCT00702234|E2|Reported Event|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
524569|NCT00702234|E1|Reported Event|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
524570|NCT00702221|B3|Baseline|Total|Total of all reporting groups
524571|NCT00702221|B2|Baseline|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524572|NCT00702221|B1|Baseline|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524573|NCT00702221|P2|Participant Flow|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524574|NCT00702221|P1|Participant Flow|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524575|NCT00702221|O2|Outcome|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524576|NCT00702221|O1|Outcome|Angiotensin Therapeutic Vaccine + CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524577|NCT00702221|E2|Reported Event|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524578|NCT00702221|E1|Reported Event|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
524579|NCT00702208|B1|Baseline|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
524627|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
531703|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
524581|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
524582|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
524583|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
524584|NCT00702208|E1|Reported Event|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
524585|NCT00702143|B4|Baseline|Total|Total of all reporting groups
524586|NCT00702143|B3|Baseline|Healthy Controls|cognitively normal (healthy) controls
524587|NCT00702143|B2|Baseline|MCI Subjects|MCI (mild cognitive impairment)
524588|NCT00702143|B1|Baseline|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
524589|NCT00702143|P3|Participant Flow|Healthy Controls|cognitively normal (healthy) controls
524590|NCT00702143|P2|Participant Flow|MCI Subjects|MCI (mild cognitive impairment)
524591|NCT00702143|P1|Participant Flow|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
524592|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
524593|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
524594|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
524595|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
524596|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
524597|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
524598|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
524599|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
524600|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
524601|NCT00702143|E1|Reported Event|All Subjects|All subjects receiving florbetapir F 18 injection
524602|NCT00701935|B3|Baseline|Total|Total of all reporting groups
524603|NCT00701935|B2|Baseline|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524604|NCT00701935|B1|Baseline|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524605|NCT00701935|P2|Participant Flow|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524606|NCT00701935|P1|Participant Flow|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524607|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524608|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524609|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524610|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524611|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524612|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524613|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524614|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524615|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524616|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524617|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524618|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524619|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524620|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524621|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524622|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524623|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524624|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524625|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524626|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524628|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524629|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524630|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524631|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524632|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524633|NCT00701935|E2|Reported Event|Placebo|Subcutaneous injection of placebo twice a day for 6 months
524634|NCT00701935|E1|Reported Event|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
524635|NCT00701805|B5|Baseline|Total|Total of all reporting groups
524636|NCT00701805|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524637|NCT00701805|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524638|NCT00701805|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524639|NCT00701805|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524640|NCT00701805|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524641|NCT00701805|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524642|NCT00701805|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524643|NCT00701805|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524644|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524645|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524646|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524753|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524754|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524755|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524647|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524648|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524649|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524650|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524651|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524652|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524653|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524654|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524655|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524656|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524657|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524658|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524659|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524660|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
525513|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
524661|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524662|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524663|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524664|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524665|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524666|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524667|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524668|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524669|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524670|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524671|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524672|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524673|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524674|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
525514|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
524675|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524676|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524677|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524678|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524679|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524680|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524681|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524682|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524683|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524684|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524685|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524686|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524687|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524688|NCT00701805|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
525515|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
524689|NCT00701805|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524690|NCT00701805|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524691|NCT00701805|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
524692|NCT00701779|B1|Baseline|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524693|NCT00701779|P1|Participant Flow|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524694|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524695|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524696|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524697|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524698|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524756|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524757|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524758|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524759|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524760|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524699|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524700|NCT00701779|E1|Reported Event|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
524701|NCT00701727|B1|Baseline|Entire Study Population|Includes groups randomized to receive ezetimibe first and placebo first
524702|NCT00701727|P2|Participant Flow|Placebo First, Ezetimibe Second|Placebo first for 7 weeks,followed by ezetimibe for 7 weeks
524703|NCT00701727|P1|Participant Flow|Ezetimibe First, Placebo Second|Ezetimibe first for 7 weeks, followed by placebo for 7 weeks
524704|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
524705|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
524706|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
524707|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
524708|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
524709|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
524710|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
524711|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
524712|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
524713|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
524714|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
524715|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
524716|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
524717|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
524718|NCT00701727|E2|Reported Event|Ezetimibe|ezetimibe, 10 mg/day, for 7 weeks
524719|NCT00701727|E1|Reported Event|Placebo|Placebo, 10 mg/day, for 7 weeks
524720|NCT00701714|B3|Baseline|Total|Total of all reporting groups
524721|NCT00701714|B2|Baseline|Treatment ERYPO|ERYPO: Solution for injection (s.c.)
524722|NCT00701714|B1|Baseline|Treatmen HX575 EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
524723|NCT00701714|P2|Participant Flow|ERYPO|ERYPO: Solution for injection (s.c.)
524724|NCT00701714|P1|Participant Flow|HX575, EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
524725|NCT00701714|O2|Outcome|Treatment ERYPO|ERYPO: Solution for injection (s.c.)
524726|NCT00701714|O1|Outcome|Treatmen HX575 EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
524727|NCT00701714|O2|Outcome|ERYPO|ERYPO: Solution for injection (s.c.)
524728|NCT00701714|O1|Outcome|HX575, EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
524729|NCT00701714|O2|Outcome|ERYPO|ERYPO: Solution for injection (s.c.)
524730|NCT00701714|O1|Outcome|HX575, EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
524731|NCT00701714|E4|Reported Event|Safety Follow-up ERYPO|Patients received ERYPO during Treatment Period
524732|NCT00701714|E3|Reported Event|Safety Follow-up HX575, EPO HEXAL|Patients received HX575, EPO HEXAL during Treatment Period
524733|NCT00701714|E2|Reported Event|Treatment ERYPO|ERYPO: Solution for injection (s.c.)
524734|NCT00701714|E1|Reported Event|Treatment HX575, EPO HEXAL|HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
524735|NCT00701675|B4|Baseline|Total|Total of all reporting groups
524736|NCT00701675|B3|Baseline|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
524737|NCT00701675|B2|Baseline|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
524738|NCT00701675|B1|Baseline|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
524739|NCT00701675|P3|Participant Flow|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
524740|NCT00701675|P2|Participant Flow|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
524741|NCT00701675|P1|Participant Flow|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
524742|NCT00701675|O3|Outcome|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
524743|NCT00701675|O2|Outcome|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
524744|NCT00701675|O1|Outcome|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
524745|NCT00701675|E3|Reported Event|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
524746|NCT00701675|E2|Reported Event|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
524747|NCT00701675|E1|Reported Event|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
524748|NCT00701662|B1|Baseline|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524749|NCT00701662|P1|Participant Flow|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524750|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524751|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524752|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524792|NCT00701415|B3|Baseline|Total|Total of all reporting groups
524761|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524762|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524763|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524764|NCT00701662|E1|Reported Event|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
524765|NCT00701636|B3|Baseline|Total|Total of all reporting groups
524766|NCT00701636|B2|Baseline|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
524767|NCT00701636|B1|Baseline|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
524768|NCT00701636|P2|Participant Flow|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
524769|NCT00701636|P1|Participant Flow|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
524770|NCT00701636|O1|Outcome|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis for CABG.
524771|NCT00701636|E2|Reported Event|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
524772|NCT00701636|E1|Reported Event|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
524773|NCT00701558|B1|Baseline|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
524774|NCT00701558|P1|Participant Flow|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
524775|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
524776|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
524777|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
524778|NCT00701558|E1|Reported Event|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
524779|NCT00701441|B3|Baseline|Total|Total of all reporting groups
524780|NCT00701441|B2|Baseline|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
524781|NCT00701441|B1|Baseline|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
524782|NCT00701441|P2|Participant Flow|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
524783|NCT00701441|P1|Participant Flow|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
524784|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(Stain Density Units)
524785|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure(Stain Density Units)
524786|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment(Stain Density Units)
524787|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(% dilation change from baseline)
524788|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure
524789|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment
524790|NCT00701441|E2|Reported Event|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
524791|NCT00701441|E1|Reported Event|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
524793|NCT00701415|B2|Baseline|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524794|NCT00701415|B1|Baseline|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524795|NCT00701415|P2|Participant Flow|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524796|NCT00701415|P1|Participant Flow|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524797|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524798|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524799|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524800|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524801|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524802|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524803|NCT00701415|E2|Reported Event|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524804|NCT00701415|E1|Reported Event|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
524805|NCT00701389|B1|Baseline|All Enrolled Participants|All participants enrolled in the study
524806|NCT00701389|P4|Participant Flow|Sequence 4: D→A→B→C|Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.
524807|NCT00701389|P3|Participant Flow|Sequence 3: C→B→A→D|Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout.
524808|NCT00701389|P2|Participant Flow|Sequence 2: B→D→C→A|Participants receive the following: Period 1:single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout.
524809|NCT00701389|P1|Participant Flow|Sequence 1: A→C→D→B|Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout.
524810|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of generic placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
524811|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of generic placebo/600 mg telcagepant in either Period 1, 2, 3, or 4 in the crossover
524812|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
524813|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
524814|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
524815|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
524816|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
524817|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
524818|NCT00701389|O2|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
524819|NCT00701389|O1|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
524820|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
524821|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
524822|NCT00701389|E4|Reported Event|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
524823|NCT00701389|E3|Reported Event|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
524824|NCT00701389|E2|Reported Event|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
524825|NCT00701389|E1|Reported Event|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
524826|NCT00701363|B5|Baseline|Total|Total of all reporting groups
524827|NCT00701363|B4|Baseline|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
524828|NCT00701363|B3|Baseline|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
524829|NCT00701363|B2|Baseline|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
524830|NCT00701363|B1|Baseline|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
524831|NCT00701363|P4|Participant Flow|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
524832|NCT00701363|P3|Participant Flow|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
524833|NCT00701363|P2|Participant Flow|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
524834|NCT00701363|P1|Participant Flow|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
524835|NCT00701363|O1|Outcome|Overall Study|
524836|NCT00701363|O1|Outcome|Overall Study|Lanreotide Autogel 120 mg injections every 6 weeks, then depending on IGF-1 results at Week 24
524837|NCT00701363|O5|Outcome|Overall Study|
524838|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
524839|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
524840|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
524841|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
524842|NCT00701363|O1|Outcome|Overall Study|
524843|NCT00701363|O1|Outcome|Overall Study|
524844|NCT00701363|O5|Outcome|Overall Study|
524845|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
524846|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
524847|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
524848|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
524849|NCT00701363|O5|Outcome|Overall Study|
524850|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
524851|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
524852|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
524853|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
524854|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
524855|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
524856|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
524899|NCT00701103|B1|Baseline|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
531704|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
524857|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|Only 15 subjects participated only in phase 1 and did not move on to phase 2. The other entered in phase 2 according to IGF-1 level. Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
524858|NCT00701363|O1|Outcome|Overall Study|
524859|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
524860|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
524861|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
524862|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
524863|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
524864|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
524865|NCT00701363|O1|Outcome|Overall Study|
524866|NCT00701363|O1|Outcome|Overall Study|
524867|NCT00701363|O1|Outcome|Overall Study|
524868|NCT00701363|O1|Outcome|Overall Study|
524869|NCT00701363|E4|Reported Event|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
524870|NCT00701363|E3|Reported Event|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
524871|NCT00701363|E2|Reported Event|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
524872|NCT00701363|E1|Reported Event|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
524873|NCT00701311|B1|Baseline|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
524874|NCT00701311|P1|Participant Flow|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
524875|NCT00701311|O1|Outcome|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
524876|NCT00701311|E1|Reported Event|Treatment Arm|Open label, one arm study.
524877|NCT00701129|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524878|NCT00701129|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 milligrams per kilogram (mg/kg) intravenous (IV) infusion every other week (qow) (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was less than (<) 6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 milligrams per square meter (mg/m^2) (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524879|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524880|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524900|NCT00701103|P11|Participant Flow|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
524901|NCT00701103|P10|Participant Flow|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
524902|NCT00701103|P9|Participant Flow|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524903|NCT00701103|P8|Participant Flow|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524881|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524882|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524883|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524884|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524885|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524886|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524887|NCT00701129|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
524888|NCT00701103|B12|Baseline|Total|Total of all reporting groups
524889|NCT00701103|B11|Baseline|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524890|NCT00701103|B10|Baseline|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524891|NCT00701103|B9|Baseline|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524892|NCT00701103|B8|Baseline|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524893|NCT00701103|B7|Baseline|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524894|NCT00701103|B6|Baseline|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524895|NCT00701103|B5|Baseline|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524896|NCT00701103|B4|Baseline|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524897|NCT00701103|B3|Baseline|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524898|NCT00701103|B2|Baseline|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
525495|NCT00700739|B3|Baseline|Total|Total of all reporting groups
524904|NCT00701103|P7|Participant Flow|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524905|NCT00701103|P6|Participant Flow|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524906|NCT00701103|P5|Participant Flow|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524907|NCT00701103|P4|Participant Flow|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524908|NCT00701103|P3|Participant Flow|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524909|NCT00701103|P2|Participant Flow|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524910|NCT00701103|P1|Participant Flow|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
524911|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524912|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524913|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524914|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524915|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524916|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524917|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524918|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524919|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524920|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524921|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524922|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524923|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524924|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524925|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524926|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524927|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524928|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524929|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524930|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524931|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524932|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524933|NCT00701103|O7|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524934|NCT00701103|O6|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
524935|NCT00701103|O5|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
524936|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
524937|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524938|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524939|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524940|NCT00701103|O7|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524941|NCT00701103|O6|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
524942|NCT00701103|O5|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
524943|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
524944|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524945|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524946|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524947|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524948|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524949|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524950|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524951|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524952|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524953|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524954|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524955|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524956|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524957|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524958|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524959|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524960|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524961|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524962|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524963|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524964|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524965|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524966|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524967|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524968|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524969|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524970|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524971|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524972|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524973|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524974|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524975|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524976|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524977|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524978|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524979|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524980|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524981|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524982|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524983|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524984|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524985|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524986|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524987|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524988|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
524989|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
524990|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
524991|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
524992|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
524993|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
524994|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
524995|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
524996|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
524997|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
524998|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
524999|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
525000|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
525001|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
525002|NCT00701103|E11|Reported Event|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
525003|NCT00701103|E10|Reported Event|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
525004|NCT00701103|E9|Reported Event|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
525005|NCT00701103|E8|Reported Event|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
525006|NCT00701103|E7|Reported Event|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
525007|NCT00701103|E6|Reported Event|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
525008|NCT00701103|E5|Reported Event|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
525009|NCT00701103|E4|Reported Event|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
525010|NCT00701103|E3|Reported Event|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
525011|NCT00701103|E2|Reported Event|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
525012|NCT00701103|E1|Reported Event|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
525013|NCT00701090|B3|Baseline|Total|Total of all reporting groups
525014|NCT00701090|B2|Baseline|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525015|NCT00701090|B1|Baseline|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525016|NCT00701090|P2|Participant Flow|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525017|NCT00701090|P1|Participant Flow|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525018|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525019|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525020|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525021|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525022|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525023|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525024|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525025|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525026|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525027|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525028|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525029|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525030|NCT00701090|E2|Reported Event|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525031|NCT00701090|E1|Reported Event|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
525032|NCT00701064|B3|Baseline|Total|Total of all reporting groups
525033|NCT00701064|B2|Baseline|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
525034|NCT00701064|B1|Baseline|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
525035|NCT00701064|P2|Participant Flow|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
525036|NCT00701064|P1|Participant Flow|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
525037|NCT00701064|O2|Outcome|Arm 2: Placebo Negative Ion Generator|"Negative Ion Generator (30 min/day)~Inactivated Negative Ion Generator: Administered via Negative Ion Generator"
525038|NCT00701064|O1|Outcome|Arm 1: Bright Light|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
525039|NCT00701064|E2|Reported Event|Arm 2: Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
525040|NCT00701064|E1|Reported Event|Arm 1: Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
525041|NCT00701051|B3|Baseline|Total|Total of all reporting groups
525042|NCT00701051|B2|Baseline|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
525043|NCT00701051|B1|Baseline|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
525044|NCT00701051|P3|Participant Flow|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening
525045|NCT00701051|P2|Participant Flow|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening
525046|NCT00701051|P1|Participant Flow|Older Adults|
525047|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
525048|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
525049|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
525050|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
525051|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
525052|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
525053|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
525054|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
525055|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
525056|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
525057|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
525058|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
525059|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
525060|NCT00701051|E1|Reported Event|Older Adults|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm); thus, data are reported for the entire group of participants.
525061|NCT00701038|B3|Baseline|Total|Total of all reporting groups
525062|NCT00701038|B2|Baseline|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
525063|NCT00701038|B1|Baseline|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
525064|NCT00701038|P2|Participant Flow|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
525065|NCT00701038|P1|Participant Flow|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
525066|NCT00701038|O2|Outcome|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
525067|NCT00701038|O1|Outcome|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
525068|NCT00701038|E2|Reported Event|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
525069|NCT00701038|E1|Reported Event|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
525070|NCT00700999|B3|Baseline|Total|Total of all reporting groups
525071|NCT00700999|B2|Baseline|Combat Exposed Controls|veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
525072|NCT00700999|B1|Baseline|Treatment Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
525073|NCT00700999|P2|Participant Flow|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
525074|NCT00700999|P1|Participant Flow|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD. Completed 12 weeks of treatment with paroxetine (20-40mg QD)
525075|NCT00700999|O2|Outcome|Combat Exposed Control|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD.
525076|NCT00700999|O1|Outcome|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
525077|NCT00700999|E2|Reported Event|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
525078|NCT00700999|E1|Reported Event|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
525079|NCT00700973|B3|Baseline|Total|Total of all reporting groups
525080|NCT00700973|B2|Baseline|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
525081|NCT00700973|B1|Baseline|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
525082|NCT00700973|P2|Participant Flow|IPV-P|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
525083|NCT00700973|P1|Participant Flow|Usual Care|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
525084|NCT00700973|O2|Outcome|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
525085|NCT00700973|O1|Outcome|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
525086|NCT00700973|E2|Reported Event|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
525087|NCT00700973|E1|Reported Event|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
525088|NCT00700817|B6|Baseline|Total|Total of all reporting groups
525089|NCT00700817|B5|Baseline|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525090|NCT00700817|B4|Baseline|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525091|NCT00700817|B3|Baseline|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525092|NCT00700817|B2|Baseline|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525093|NCT00700817|B1|Baseline|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525094|NCT00700817|P5|Participant Flow|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525095|NCT00700817|P4|Participant Flow|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525096|NCT00700817|P3|Participant Flow|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525097|NCT00700817|P2|Participant Flow|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525098|NCT00700817|P1|Participant Flow|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525099|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525100|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525101|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525102|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525103|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525104|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525105|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525106|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525107|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525108|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525109|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525110|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525111|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525112|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525113|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525114|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525115|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525116|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525117|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525118|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525119|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525120|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525121|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525122|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525123|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525124|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525125|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525126|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525496|NCT00700739|B2|Baseline|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525497|NCT00700739|B1|Baseline|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525127|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525128|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525129|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525130|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525131|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525132|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525133|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525134|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525135|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525136|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525137|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525138|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525139|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525140|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525141|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525142|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525143|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525144|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525145|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525146|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525147|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
531705|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
525148|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525149|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525150|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525151|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525152|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525153|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525154|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525155|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525156|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525157|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525158|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525159|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525160|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525161|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525162|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525163|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525164|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525165|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525166|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525167|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525168|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
531706|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
525169|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525170|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525171|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525172|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525173|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525174|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525175|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525176|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525177|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525178|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525179|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525180|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525181|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525182|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525183|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525184|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525185|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525186|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525187|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525188|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525189|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525498|NCT00700739|P2|Participant Flow|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525190|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525191|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525192|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525193|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525194|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525195|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525196|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525197|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525198|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525199|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525200|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525201|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525202|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525203|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525204|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525205|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525206|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525207|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525208|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525209|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525210|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525499|NCT00700739|P1|Participant Flow|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
525211|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525212|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525213|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525214|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525215|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525216|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525217|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525218|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525219|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525220|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525221|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525222|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525223|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525224|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525225|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525226|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525227|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525228|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525229|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525230|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525231|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525500|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525501|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525232|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525233|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525234|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525235|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525236|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525237|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525238|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525239|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525240|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525241|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525242|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525243|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525244|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525245|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525246|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525247|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525248|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525249|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525250|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525251|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525252|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
531707|NCT00684307|O5|Outcome|VKA INR 2-3|
525253|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525254|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525255|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525256|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525257|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525258|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525259|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525260|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525261|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525262|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525263|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525264|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525265|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525266|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525267|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525268|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525269|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525270|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525271|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525272|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525273|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
531708|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
525274|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525275|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525276|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525277|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525278|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525279|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525280|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525281|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525282|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525283|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525284|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525285|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525286|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525287|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525288|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525289|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525290|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525291|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525292|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525293|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525294|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525502|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525295|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525296|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525297|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525298|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525299|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525300|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525301|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525302|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525303|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525304|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525305|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525306|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525307|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525308|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525309|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525310|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525311|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525312|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525313|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525314|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525315|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525503|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525316|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525317|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525318|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525319|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525320|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525321|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525322|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525323|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525324|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525325|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525326|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525327|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525328|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525329|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525330|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525331|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525332|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525333|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525334|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525335|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525336|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525504|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525505|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525337|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525338|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525339|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525340|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525341|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525342|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525343|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525344|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525345|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525346|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525347|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525348|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525349|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525350|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525351|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525352|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525353|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525354|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525355|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525356|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525357|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
531709|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
525358|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525359|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525360|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525361|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525362|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525363|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525364|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525365|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525366|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525367|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525368|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525369|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525370|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525371|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525372|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525373|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525374|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525375|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525376|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525377|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525378|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
531710|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
525379|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525380|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525381|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525382|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525383|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525384|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525385|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525386|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525387|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525388|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525389|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525390|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525391|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525392|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525393|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525394|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525395|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525396|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525397|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525398|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525399|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525506|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525400|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525401|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525402|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525403|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525404|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525405|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525406|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525407|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525408|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525409|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525410|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525411|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525412|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525413|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525414|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525415|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525416|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525417|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525418|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525419|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525420|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525507|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525421|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525422|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525423|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525424|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525425|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525426|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525427|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525428|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525429|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525430|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525431|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525432|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525433|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525434|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525435|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525436|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525437|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525438|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525439|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525440|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525441|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525508|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525509|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525442|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525443|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525444|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525445|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525446|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525447|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525448|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525449|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525450|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525451|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525452|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525453|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525454|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525455|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525456|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525457|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525458|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525459|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525460|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525461|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525462|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
531711|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
525463|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525464|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525465|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525466|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525467|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525468|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525469|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
525470|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
525471|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525472|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525473|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525474|NCT00700817|E3|Reported Event|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
525475|NCT00700817|E2|Reported Event|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525476|NCT00700817|E1|Reported Event|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
525477|NCT00700804|B3|Baseline|Total|Total of all reporting groups
525478|NCT00700804|B2|Baseline|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
525479|NCT00700804|B1|Baseline|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
525480|NCT00700804|P2|Participant Flow|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
525481|NCT00700804|P1|Participant Flow|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
525482|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
525483|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
525484|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
525485|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
525486|NCT00700804|E2|Reported Event|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
525487|NCT00700804|E1|Reported Event|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
525488|NCT00700752|B1|Baseline|Overall|Completed study population
525489|NCT00700752|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
525490|NCT00700752|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
525491|NCT00700752|O2|Outcome|Balafilcon A|silicone hydrogel contact lens worn daily with a 4-week replacement regimen
525492|NCT00700752|O1|Outcome|Senofilcon A|silicone hydrogel contact lens worn daily with a 2-week replacement regimen.
525493|NCT00700752|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
525494|NCT00700752|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
531712|NCT00684307|O5|Outcome|VKA INR 2-3|
525516|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525517|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525518|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525519|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525520|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525521|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
525522|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525523|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
525524|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525525|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
525526|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525527|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
525528|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525529|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525530|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525531|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525532|NCT00700739|E2|Reported Event|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
525533|NCT00700739|E1|Reported Event|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
525534|NCT00700713|B4|Baseline|Total|Total of all reporting groups
525535|NCT00700713|B3|Baseline|Menactra-naïve Group|Participants had never received Menactra® vaccine.
525536|NCT00700713|B2|Baseline|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26
525537|NCT00700713|B1|Baseline|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
525538|NCT00700713|P3|Participant Flow|Menactra-naïve Group|Participants had never received Menactra® vaccine.
525539|NCT00700713|P2|Participant Flow|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
525540|NCT00700713|P1|Participant Flow|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
525541|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
525542|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
525543|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
525544|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
525545|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
525546|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
525547|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
525548|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
525549|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
525550|NCT00700713|E3|Reported Event|Menactra-naïve Group|Participants had never received Menactra® vaccine.
525551|NCT00700713|E2|Reported Event|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
525552|NCT00700713|E1|Reported Event|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
525553|NCT00700635|B4|Baseline|Total|Total of all reporting groups
525554|NCT00700635|B3|Baseline|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525555|NCT00700635|B2|Baseline|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525556|NCT00700635|B1|Baseline|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
525557|NCT00700635|P3|Participant Flow|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525558|NCT00700635|P2|Participant Flow|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525559|NCT00700635|P1|Participant Flow|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
525560|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525561|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525562|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
525563|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525564|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525565|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
525566|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525567|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525568|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
525569|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525570|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525571|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
525572|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525573|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525574|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
531713|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
525575|NCT00700635|E3|Reported Event|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
525576|NCT00700635|E2|Reported Event|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
525577|NCT00700635|E1|Reported Event|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
525578|NCT00700622|B3|Baseline|Total|Total of all reporting groups
525579|NCT00700622|B2|Baseline|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
525580|NCT00700622|B1|Baseline|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
525581|NCT00700622|P2|Participant Flow|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
525582|NCT00700622|P1|Participant Flow|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
525583|NCT00700622|O2|Outcome|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
525584|NCT00700622|O1|Outcome|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
525585|NCT00700622|E2|Reported Event|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
525586|NCT00700622|E1|Reported Event|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
525587|NCT00700570|B3|Baseline|Total|Total of all reporting groups
525588|NCT00700570|B2|Baseline|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
525589|NCT00700570|B1|Baseline|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
525590|NCT00700570|P2|Participant Flow|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, repeated neoadjuvant treatment until documented resectability or progressive disease (PD). Participants could be withdrawn at any point for unacceptable toxicity.
525591|NCT00700570|P1|Participant Flow|Resected|Participants with unresectable liver metastases secondary to colorectal cancer (CRC) were assigned to receive neoadjuvant treatment of intravenous (IV) bevacizumab with oral (PO) capecitabine and IV oxaliplatin (XELOX). Bevacizumab was given as 5 milligrams per kilogram (mg/kg) on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 milligrams per meter-squared (mg/m^2) on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
525592|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
525593|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
525594|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
525782|NCT00700063|P1|Participant Flow|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
531714|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
525595|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
525596|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
525597|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
525598|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
525599|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
525600|NCT00700570|O1|Outcome|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
525601|NCT00700570|E1|Reported Event|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
525602|NCT00700440|B1|Baseline|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
525603|NCT00700440|P1|Participant Flow|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
525604|NCT00700440|O1|Outcome|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
525605|NCT00700440|E1|Reported Event|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
525606|NCT00700427|B1|Baseline|Atomoxetine (40-100 mg)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment period (Study Period 2).
525607|NCT00700427|P5|Participant Flow|Atomoxetine (Study Period 4)|Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.
525608|NCT00700427|P4|Participant Flow|Placebo (Study Period 3B)|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525609|NCT00700427|P3|Participant Flow|Atomoxetine (Study Period 3B)|80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525610|NCT00700427|P2|Participant Flow|Atomoxetine (Study Period 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3).
525611|NCT00700427|P1|Participant Flow|Atomoxetine (Study Period 2)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).
525612|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525613|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525614|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525615|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525616|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525617|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525618|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525619|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525620|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525621|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525622|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525623|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525624|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525625|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525626|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525627|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
525628|NCT00700427|E4|Reported Event|Atomoxetine (Study Period 4; Open-Label Extension)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A) and for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B), followed by a 2 year open label extension (Study Period 4). The open-label extension was optional and only offered to participants living in countries where atomoxetine for the adult ADHD indication had not been approved who had completed the Study Period 3B and were receiving benefit from the drug.
525629|NCT00700427|E3|Reported Event|Placebo (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
525630|NCT00700427|E2|Reported Event|Atomoxetine (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
525631|NCT00700427|E1|Reported Event|Atomoxetine (Study Periods 2 and 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).
525632|NCT00700401|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525633|NCT00700401|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525634|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525635|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525636|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525637|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525638|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525639|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525640|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525641|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525642|NCT00700401|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
525643|NCT00700375|B3|Baseline|Total|Total of all reporting groups
525644|NCT00700375|B2|Baseline|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525645|NCT00700375|B1|Baseline|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525646|NCT00700375|P2|Participant Flow|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525647|NCT00700375|P1|Participant Flow|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525648|NCT00700375|O2|Outcome|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525649|NCT00700375|O1|Outcome|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525650|NCT00700375|E2|Reported Event|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525651|NCT00700375|E1|Reported Event|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
525652|NCT00700310|B5|Baseline|Total|Total of all reporting groups
525653|NCT00700310|B4|Baseline|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
525654|NCT00700310|B3|Baseline|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
525655|NCT00700310|B2|Baseline|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525656|NCT00700310|B1|Baseline|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525657|NCT00700310|P4|Participant Flow|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
525658|NCT00700310|P3|Participant Flow|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
525659|NCT00700310|P2|Participant Flow|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525660|NCT00700310|P1|Participant Flow|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525661|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
525662|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
525663|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525664|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525665|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
525666|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
525667|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525668|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525669|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
525670|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
525671|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525672|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525673|NCT00700310|E4|Reported Event|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
525674|NCT00700310|E3|Reported Event|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
525675|NCT00700310|E2|Reported Event|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525676|NCT00700310|E1|Reported Event|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
525677|NCT00700271|B3|Baseline|Total|Total of all reporting groups
525678|NCT00700271|B2|Baseline|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525679|NCT00700271|B1|Baseline|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525783|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525784|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525680|NCT00700271|P2|Participant Flow|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525681|NCT00700271|P1|Participant Flow|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525682|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525683|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525684|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525685|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525686|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525687|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525688|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525689|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525785|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525786|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525787|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525690|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525691|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525692|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525693|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525694|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525695|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525696|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525697|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525698|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525699|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525788|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525789|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525790|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525700|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525701|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525702|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525703|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525704|NCT00700271|E2|Reported Event|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525705|NCT00700271|E1|Reported Event|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
525706|NCT00700180|B3|Baseline|Total|Total of all reporting groups
525707|NCT00700180|B2|Baseline|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525708|NCT00700180|B1|Baseline|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525709|NCT00700180|P2|Participant Flow|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525719|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525710|NCT00700180|P1|Participant Flow|Bevacizumab 7.5 Milligrams (mg) Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg per kilogram (mg/kg) intravenously (IV) on Day 1; either carboplatin at a dose required to achieve an area under the concentration-time curve (AUC) of 6 mg per milliliter (mg/mL) IV and paclitaxel 200 mg per square meter (mg/m^2) IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525711|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525712|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525713|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525714|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525715|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525716|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525717|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525718|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525773|NCT00700063|B2|Baseline|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525774|NCT00700063|B1|Baseline|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525775|NCT00700063|P8|Participant Flow|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525776|NCT00700063|P7|Participant Flow|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525720|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525721|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525722|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525723|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525724|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525725|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525726|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525727|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525728|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525777|NCT00700063|P6|Participant Flow|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525778|NCT00700063|P5|Participant Flow|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525779|NCT00700063|P4|Participant Flow|4. Vehicle Gel|Two days treatment, day 1, 2
525780|NCT00700063|P3|Participant Flow|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525781|NCT00700063|P2|Participant Flow|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525729|NCT00700180|E2|Reported Event|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525730|NCT00700180|E1|Reported Event|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
525731|NCT00700141|B1|Baseline|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
525732|NCT00700141|P1|Participant Flow|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
525733|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
525734|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
525735|NCT00700141|E1|Reported Event|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
525736|NCT00700115|B3|Baseline|Total|Total of all reporting groups
525737|NCT00700115|B2|Baseline|Standard HAART|Pre-study standard HAART regimen
525738|NCT00700115|B1|Baseline|Kaletra + Isentress|switched to Kaletra + Isentress
525739|NCT00700115|P2|Participant Flow|Standard HAART|Pre-study standard HAART regimen
525740|NCT00700115|P1|Participant Flow|Kaletra + Isentress|Switched to Kaletra + Isentress
525741|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
525742|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
525743|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
525744|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
525745|NCT00700115|E2|Reported Event|Standard HAART|Pre-study standard HAART regimen
525746|NCT00700115|E1|Reported Event|Kaletra + Isentress|switched to Kaletra + Isentress
525747|NCT00700102|B3|Baseline|Total|Total of all reporting groups
525748|NCT00700102|B2|Baseline|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
525749|NCT00700102|B1|Baseline|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
525750|NCT00700102|P2|Participant Flow|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
525751|NCT00700102|P1|Participant Flow|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
525752|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
525753|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
525754|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
525755|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
525756|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
525757|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
525758|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
525759|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
525760|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
525761|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
525762|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
525763|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
525764|NCT00700102|E2|Reported Event|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
525765|NCT00700102|E1|Reported Event|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
525766|NCT00700063|B9|Baseline|Total|Total of all reporting groups
525767|NCT00700063|B8|Baseline|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525768|NCT00700063|B7|Baseline|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525769|NCT00700063|B6|Baseline|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525770|NCT00700063|B5|Baseline|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525771|NCT00700063|B4|Baseline|4. Vehicle Gel|Two days treatment, day 1, 2
525772|NCT00700063|B3|Baseline|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525791|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525792|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525793|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525794|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525795|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525796|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525797|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525798|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525799|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525800|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525801|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525802|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525803|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525804|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525805|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525806|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525807|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525808|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525809|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525810|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525811|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525812|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525813|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525814|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525815|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525816|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525817|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525818|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525819|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525820|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525821|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525822|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525823|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525824|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525825|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525826|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525827|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525828|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525829|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525830|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525831|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525832|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525833|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525834|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525835|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525836|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525837|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525838|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525839|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525840|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525841|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525842|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525843|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525844|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525845|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525846|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525847|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525848|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525849|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525850|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525851|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525852|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525853|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525854|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525855|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525856|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525857|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525858|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525859|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525860|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525861|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525862|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525863|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525864|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525865|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525866|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525867|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525868|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525869|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525870|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525871|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525872|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525873|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525874|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525875|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
525876|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525877|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525878|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525879|NCT00700063|E8|Reported Event|8. Vehicle Gel|Three days treatment, day 1, 2, 3
525880|NCT00700063|E7|Reported Event|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
525881|NCT00700063|E6|Reported Event|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
525882|NCT00700063|E5|Reported Event|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
525883|NCT00700063|E4|Reported Event|4. Vehicle Gel|Two days treatment, day 1, 2
525884|NCT00700063|E3|Reported Event|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
525885|NCT00700063|E2|Reported Event|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
525886|NCT00700063|E1|Reported Event|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
525887|NCT00700011|B3|Baseline|Total|Total of all reporting groups
525888|NCT00700011|B2|Baseline|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525889|NCT00700011|B1|Baseline|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525890|NCT00700011|P2|Participant Flow|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525891|NCT00700011|P1|Participant Flow|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525892|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525893|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525894|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525895|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525896|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525897|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525898|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525988|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
531715|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
525899|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525900|NCT00700011|E2|Reported Event|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525901|NCT00700011|E1|Reported Event|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
525902|NCT00699998|B5|Baseline|Total|Total of all reporting groups
525903|NCT00699998|B4|Baseline|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525904|NCT00699998|B3|Baseline|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525905|NCT00699998|B2|Baseline|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
525906|NCT00699998|B1|Baseline|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525907|NCT00699998|P4|Participant Flow|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
525908|NCT00699998|P3|Participant Flow|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
525909|NCT00699998|P2|Participant Flow|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study."
525910|NCT00699998|P1|Participant Flow|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
525911|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
525912|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel : 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
525913|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg orally, once daily as maintenance dose through end of study."
525914|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
525915|NCT00699998|O2|Outcome|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525989|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
531716|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
525916|NCT00699998|O1|Outcome|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
525917|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525918|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525919|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
525920|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525921|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525922|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525923|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
525924|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525925|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525926|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525927|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
525928|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525929|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525930|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525931|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
526686|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|
525932|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525933|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525934|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525935|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
525936|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525937|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525938|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525939|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
525940|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525941|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525942|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525943|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
525944|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525945|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525946|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525947|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
531717|NCT00684307|O5|Outcome|VKA INR 2-3|
525948|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
525949|NCT00699998|E2|Reported Event|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
525950|NCT00699998|E1|Reported Event|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
525951|NCT00699972|B4|Baseline|Total|Total of all reporting groups
525952|NCT00699972|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
525953|NCT00699972|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
525954|NCT00699972|B1|Baseline|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
525955|NCT00699972|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
525956|NCT00699972|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
525957|NCT00699972|P1|Participant Flow|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
525958|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
525959|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
525960|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
525961|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
525962|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
525963|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
525964|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
525965|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
525966|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
525967|NCT00699972|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
525968|NCT00699972|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
525969|NCT00699972|E1|Reported Event|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
525970|NCT00699907|B4|Baseline|Total|Total of all reporting groups
525971|NCT00699907|B3|Baseline|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525972|NCT00699907|B2|Baseline|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525973|NCT00699907|B1|Baseline|Treatment Arm|"Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.~flutamide: Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity."
525974|NCT00699907|P3|Participant Flow|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525975|NCT00699907|P2|Participant Flow|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525976|NCT00699907|P1|Participant Flow|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
525977|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525978|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525979|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
525980|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525981|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525982|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
525983|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525984|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525985|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
525986|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525987|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
526687|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|
525990|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525991|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
525992|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525993|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525994|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
525995|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525996|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
525997|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
525998|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
525999|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
526000|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
526001|NCT00699907|O3|Outcome|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
526002|NCT00699907|O2|Outcome|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
526003|NCT00699907|O1|Outcome|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
526004|NCT00699907|E3|Reported Event|Low Risk Arm|Low risk patients underwent salpingo-oophorectomy for a medical indication.
526005|NCT00699907|E2|Reported Event|High Risk Arm|High risk patients underwent risk-reducing salpingo-oophorectomy.
526006|NCT00699907|E1|Reported Event|Treatment Arm|Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy.
526007|NCT00699842|B4|Baseline|Total|Total of all reporting groups
526008|NCT00699842|B3|Baseline|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526009|NCT00699842|B2|Baseline|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526010|NCT00699842|B1|Baseline|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526011|NCT00699842|P3|Participant Flow|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526012|NCT00699842|P2|Participant Flow|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526013|NCT00699842|P1|Participant Flow|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526014|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526015|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526016|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526017|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526018|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526019|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526020|NCT00699842|E3|Reported Event|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526078|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
531718|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
526021|NCT00699842|E2|Reported Event|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526022|NCT00699842|E1|Reported Event|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
526023|NCT00699816|B3|Baseline|Total|Total of all reporting groups
526024|NCT00699816|B2|Baseline|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526025|NCT00699816|B1|Baseline|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526026|NCT00699816|P2|Participant Flow|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526027|NCT00699816|P1|Participant Flow|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526028|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526029|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526030|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526031|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526032|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526033|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526034|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526035|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526036|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526037|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526038|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526039|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526160|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
526040|NCT00699816|E2|Reported Event|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
526041|NCT00699816|E1|Reported Event|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
526042|NCT00699751|B3|Baseline|Total|Total of all reporting groups
526043|NCT00699751|B2|Baseline|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526044|NCT00699751|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526045|NCT00699751|P2|Participant Flow|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
526046|NCT00699751|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received BSoC plus radium223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
526047|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526048|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526049|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526050|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526051|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526052|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526053|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526054|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526055|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526056|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526057|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526058|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526059|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526060|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526061|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526062|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526063|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526064|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526065|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526066|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526067|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526068|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526069|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526070|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526071|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526072|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526073|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526074|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526075|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526076|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526077|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526161|NCT00699608|O1|Outcome|Placebo|Placebo
526079|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526080|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526081|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526082|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526083|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526084|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526085|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526086|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526087|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526088|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526089|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526090|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526091|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526092|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526093|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526094|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526095|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526096|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526097|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526098|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526099|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526100|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526101|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526102|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526103|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526104|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526105|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526106|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526107|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526108|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526109|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526110|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526111|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526112|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526113|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526114|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526115|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526116|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526117|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526118|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526119|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526162|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
526163|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
526120|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526121|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526122|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526123|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526124|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526125|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
526126|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
526127|NCT00699751|E3|Reported Event|Placebo Randomized, Then Switched to Radium-223 Dichloride|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
526128|NCT00699751|E2|Reported Event|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase.
526129|NCT00699751|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Subjects received BSoC plus radium-223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
526130|NCT00699699|B1|Baseline|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
526131|NCT00699699|P1|Participant Flow|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
526132|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
526133|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
526134|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
526135|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
526136|NCT00699699|E1|Reported Event|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
526137|NCT00699660|B3|Baseline|Total|Total of all reporting groups
526138|NCT00699660|B2|Baseline|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
526139|NCT00699660|B1|Baseline|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
526140|NCT00699660|P2|Participant Flow|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
526141|NCT00699660|P1|Participant Flow|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
526142|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
526143|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
526144|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
526145|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
526146|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
526147|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
526148|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
526149|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
526150|NCT00699660|E2|Reported Event|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
526151|NCT00699660|E1|Reported Event|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
526152|NCT00699608|B1|Baseline|Entire Study Population|
526153|NCT00699608|P6|Participant Flow|Placebo First, Zopiclone Second, Eszopiclone Third|Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
526154|NCT00699608|P5|Participant Flow|Placebo First, Eszopiclone Second, Zopiclone Third|Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
526155|NCT00699608|P4|Participant Flow|Zopiclone First, Placebo Second, Eszopiclone Third|7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
526156|NCT00699608|P3|Participant Flow|Zopiclone First, Eszopiclone Second, Placebo Third|7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
526157|NCT00699608|P2|Participant Flow|Eszopiclone First, Placebo Second, Zopiclone Third|3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
526158|NCT00699608|P1|Participant Flow|Eszopiclone First, Zopiclone Second, Placebo Third|3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
526159|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
526208|NCT00699582|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
526209|NCT00699582|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
526210|NCT00699582|B1|Baseline|Placebo|
526211|NCT00699582|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
526212|NCT00699582|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
526213|NCT00699582|P1|Participant Flow|Placebo|
526214|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
526215|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
526216|NCT00699582|O1|Outcome|Placebo|
526217|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
526218|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
526219|NCT00699582|O1|Outcome|Placebo|
526220|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
526221|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
526222|NCT00699582|O1|Outcome|Placebo|
526223|NCT00699582|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
526224|NCT00699582|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
526225|NCT00699582|E1|Reported Event|Placebo|
526226|NCT00699556|B1|Baseline|Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)~The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.~Or~Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale."
526227|NCT00699556|P2|Participant Flow|Nicotine Patch+Placebo Spray First, Then Nicotine Patch+Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)~The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.~Or~Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale."
526228|NCT00699556|P1|Participant Flow|Nicotine Patch+Spray First, Then Nicotine Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg)~The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.~Or~Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale."
526229|NCT00699556|O2|Outcome|Nicotine Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital."
526230|NCT00699556|O1|Outcome|Nicotine Patch+ Nicotine Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol."
526231|NCT00699556|O2|Outcome|Nicotine Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital."
526232|NCT00699556|O1|Outcome|Nicotine Patch+Nicotine Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol."
526233|NCT00699556|E2|Reported Event|Patch+Placebo Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital."
526234|NCT00699556|E1|Reported Event|Patch+Spray|"Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray.~21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch~1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol."
526235|NCT00699491|B7|Baseline|Total|Total of all reporting groups
526236|NCT00699491|B6|Baseline|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526237|NCT00699491|B5|Baseline|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526238|NCT00699491|B4|Baseline|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526239|NCT00699491|B3|Baseline|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526240|NCT00699491|B2|Baseline|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526241|NCT00699491|B1|Baseline|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526242|NCT00699491|P6|Participant Flow|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526243|NCT00699491|P5|Participant Flow|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526244|NCT00699491|P4|Participant Flow|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526245|NCT00699491|P3|Participant Flow|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526246|NCT00699491|P2|Participant Flow|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526247|NCT00699491|P1|Participant Flow|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526248|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526249|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526250|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526251|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526252|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526253|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526254|NCT00699491|O5|Outcome|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526255|NCT00699491|O4|Outcome|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526256|NCT00699491|O3|Outcome|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526257|NCT00699491|O2|Outcome|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526258|NCT00699491|O1|Outcome|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
526259|NCT00699491|E6|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
526260|NCT00699491|E5|Reported Event|Dose Level -2B|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
526261|NCT00699491|E4|Reported Event|Dose Level -2A|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
526262|NCT00699491|E3|Reported Event|Dose Level -2|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
526263|NCT00699491|E2|Reported Event|Dose Level -1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
526264|NCT00699491|E1|Reported Event|Dose Level 1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
526265|NCT00699413|B3|Baseline|Total|Total of all reporting groups
526266|NCT00699413|B2|Baseline|Control Arm|nutrition education plus inactive supplement
526267|NCT00699413|B1|Baseline|Intervention Arm|nutrition education plus active supplement
526268|NCT00699413|P2|Participant Flow|Control Arm|nutrition education plus inactive supplement
526269|NCT00699413|P1|Participant Flow|Intervention Arm|nutrition education plus active supplement
526270|NCT00699413|O2|Outcome|Control Arm|nutrition education plus inactive supplement
526271|NCT00699413|O1|Outcome|Intervention Arm|nutrition education plus active supplement
526272|NCT00699413|E2|Reported Event|Control Arm|nutrition education plus inactive supplement
526273|NCT00699413|E1|Reported Event|Intervention Arm|nutrition education plus active supplement
526274|NCT00699400|B4|Baseline|Total|Total of all reporting groups
526275|NCT00699400|B3|Baseline|Pre-Freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
526276|NCT00699400|B2|Baseline|Vitrification|Subjects that participated in one or more vitrification cycles
526277|NCT00699400|B1|Baseline|Slow Freeze|Subjects that participated in one or more slow-freeze cycles
526278|NCT00699400|P6|Participant Flow|Pre-freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
526279|NCT00699400|P5|Participant Flow|Both (Slow Freeze and Vitrification)|Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique).
526280|NCT00699400|P4|Participant Flow|Vitrification (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
526281|NCT00699400|P3|Participant Flow|Vitrification (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
526282|NCT00699400|P2|Participant Flow|Slow Freeze (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
526283|NCT00699400|P1|Participant Flow|Slow Freeze (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
526284|NCT00699400|O3|Outcome|All Participants|
526285|NCT00699400|O2|Outcome|Vitrification|
526286|NCT00699400|O1|Outcome|Slow Freezing|
526287|NCT00699400|O3|Outcome|All Participants|
526288|NCT00699400|O2|Outcome|Vitrification|
526289|NCT00699400|O1|Outcome|Slow Freezing|
526290|NCT00699400|O3|Outcome|All Participants|
526291|NCT00699400|O2|Outcome|Vitrification|
526292|NCT00699400|O1|Outcome|Slow Freezing|
526293|NCT00699400|O3|Outcome|All Participants|
526294|NCT00699400|O2|Outcome|Vitrification|
526295|NCT00699400|O1|Outcome|Slow Freezing|
526296|NCT00699400|O3|Outcome|All Participants|
526297|NCT00699400|O2|Outcome|Vitrification|
526298|NCT00699400|O1|Outcome|Slow Freezing|
526299|NCT00699400|O3|Outcome|All Participants|
526300|NCT00699400|O2|Outcome|Vitrification|
526301|NCT00699400|O1|Outcome|Slow Freezing|
526302|NCT00699400|O3|Outcome|All Participants|
526303|NCT00699400|O2|Outcome|Vitrification|
526304|NCT00699400|O1|Outcome|Slow Freezing|
526305|NCT00699400|O3|Outcome|All Participants|
526306|NCT00699400|O2|Outcome|Vitrification|
526307|NCT00699400|O1|Outcome|Slow Freezing|
526308|NCT00699400|O3|Outcome|All Participants|
526309|NCT00699400|O2|Outcome|Vitrification|
526310|NCT00699400|O1|Outcome|Slow Freezing|
526311|NCT00699400|E3|Reported Event|All Participants|
526312|NCT00699400|E2|Reported Event|Vitrification|
526313|NCT00699400|E1|Reported Event|Slow Freezing|
526314|NCT00699374|B3|Baseline|Total|Total of all reporting groups
526315|NCT00699374|B2|Baseline|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526316|NCT00699374|B1|Baseline|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526317|NCT00699374|P2|Participant Flow|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526318|NCT00699374|P1|Participant Flow|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526319|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526320|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526321|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526322|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526323|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526324|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526325|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526326|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526327|NCT00699374|E2|Reported Event|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526328|NCT00699374|E1|Reported Event|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
526329|NCT00699348|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526330|NCT00699348|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period [Week -4 to Week 0]) intravenous methoxy polyethylene glycolepoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
526331|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526332|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526333|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526334|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526335|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526336|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526337|NCT00699348|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
526338|NCT00699335|B1|Baseline|Matrifen®|All patients enrolled
526339|NCT00699335|P1|Participant Flow|Matrifen®|All patients enrolled
526340|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
526341|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
526342|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
526343|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
526344|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526345|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526346|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526347|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526348|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
526349|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
526350|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526351|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526352|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526353|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526354|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526355|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526356|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526357|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526358|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526359|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526360|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526361|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526362|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526363|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526364|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
526365|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
526366|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
526367|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
526368|NCT00699335|E1|Reported Event|Matrifen®|Patients included and treated with at least one application of Matrifen®
526369|NCT00699283|B3|Baseline|Total Title|
526370|NCT00699283|B2|Baseline|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
526371|NCT00699283|B1|Baseline|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
526372|NCT00699283|P2|Participant Flow|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
526373|NCT00699283|P1|Participant Flow|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
526374|NCT00699283|O1|Outcome|Efficacy Set (Brivaracetam 50 mg Treated Subjects)|"50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).~The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs."
526375|NCT00699283|E2|Reported Event|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
526376|NCT00699283|E1|Reported Event|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
526377|NCT00699192|B4|Baseline|Total|Total of all reporting groups
526378|NCT00699192|B3|Baseline|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
526379|NCT00699192|B2|Baseline|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526380|NCT00699192|B1|Baseline|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526381|NCT00699192|P3|Participant Flow|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
526382|NCT00699192|P2|Participant Flow|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526383|NCT00699192|P1|Participant Flow|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526384|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
531719|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
526385|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526386|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526387|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
526388|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526389|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526390|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
526391|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526392|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526393|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
526394|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526395|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526396|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
526397|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526398|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526399|NCT00699192|E3|Reported Event|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
526400|NCT00699192|E2|Reported Event|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
526401|NCT00699192|E1|Reported Event|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
526402|NCT00699153|B3|Baseline|Total|Total of all reporting groups
526403|NCT00699153|B2|Baseline|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
526404|NCT00699153|B1|Baseline|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
526405|NCT00699153|P2|Participant Flow|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
526406|NCT00699153|P1|Participant Flow|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
526407|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
526408|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
526409|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
526410|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
526411|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
526412|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
526413|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
526414|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
526415|NCT00699153|E2|Reported Event|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
526416|NCT00699153|E1|Reported Event|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
526417|NCT00699140|B1|Baseline|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
526418|NCT00699140|P1|Participant Flow|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
526419|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
526420|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
526421|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
526422|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols. IGIV3I Grifols: Immune Globulin Intravenous (Human). All adverse events (AEs) are tabulated and summarized. Incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of MedDRA.~The frequency of patients and infusions associated with at least one AE are estimated as the primary safety endpoint."
526423|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
526424|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
526425|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
526426|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
526688|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|
526689|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion|
526427|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
526428|NCT00699140|E1|Reported Event|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
526429|NCT00698932|B3|Baseline|Total|Total of all reporting groups
526430|NCT00698932|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526431|NCT00698932|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526432|NCT00698932|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526433|NCT00698932|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526434|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526435|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526436|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526437|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526438|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526439|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526440|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526441|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526442|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526443|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526444|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526445|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526446|NCT00698932|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
526447|NCT00698932|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
526448|NCT00698867|B1|Baseline|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526449|NCT00698867|P1|Participant Flow|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526450|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526451|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526452|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526453|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526454|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526455|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526456|NCT00698867|O1|Outcome|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526457|NCT00698867|E1|Reported Event|Discovery™ Elbow|Discovery™ Elbow minimally constrained
526458|NCT00698841|B1|Baseline|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526459|NCT00698841|P1|Participant Flow|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526460|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526461|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526462|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526463|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526464|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526465|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526466|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526467|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526468|NCT00698841|E1|Reported Event|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
526469|NCT00698815|B4|Baseline|Total|Total of all reporting groups
526470|NCT00698815|B3|Baseline|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
526471|NCT00698815|B2|Baseline|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
526472|NCT00698815|B1|Baseline|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
526473|NCT00698815|P3|Participant Flow|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
526474|NCT00698815|P2|Participant Flow|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
526475|NCT00698815|P1|Participant Flow|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
526476|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
526477|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
526478|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
526479|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
526480|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
526481|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
526482|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
526483|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
526484|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
526485|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
526486|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
526487|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
526488|NCT00698815|E3|Reported Event|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
526489|NCT00698815|E2|Reported Event|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
526490|NCT00698815|E1|Reported Event|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
526491|NCT00698685|B1|Baseline|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
526516|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526833|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526492|NCT00698685|P1|Participant Flow|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
526493|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
526494|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
526495|NCT00698685|E1|Reported Event|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
526496|NCT00698646|B4|Baseline|Total|Total of all reporting groups
526497|NCT00698646|B3|Baseline|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526498|NCT00698646|B2|Baseline|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526499|NCT00698646|B1|Baseline|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526500|NCT00698646|P3|Participant Flow|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526501|NCT00698646|P2|Participant Flow|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526502|NCT00698646|P1|Participant Flow|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526503|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526504|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526505|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526506|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526507|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526508|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526509|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526510|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526511|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526512|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526513|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526514|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526515|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526594|NCT00698035|P2|Participant Flow|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526517|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526518|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526519|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526520|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526521|NCT00698646|E3|Reported Event|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
526522|NCT00698646|E2|Reported Event|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
526523|NCT00698646|E1|Reported Event|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
526524|NCT00698581|B3|Baseline|Total Title|
526525|NCT00698581|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
526526|NCT00698581|B1|Baseline|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
526527|NCT00698581|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
526528|NCT00698581|P1|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
526529|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
526530|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
526531|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
526532|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
526533|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
526534|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
526535|NCT00698581|O1|Outcome|Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
526536|NCT00698581|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
526537|NCT00698581|E1|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
526538|NCT00698516|B1|Baseline|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
526539|NCT00698516|P1|Participant Flow|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
526540|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
526541|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
526542|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
526543|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
526544|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
526545|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
526546|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensistive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
526547|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
526548|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
526549|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
526550|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
526551|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
526552|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
526595|NCT00698035|P1|Participant Flow|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
527082|NCT00696761|E1|Reported Event|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
526553|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
526554|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
526555|NCT00698516|E1|Reported Event|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 mg/m^2/day for 5 consecutive days (Days 1 to 5) and IV bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GSK’s study physician was needed for subjects who required treatment beyond 8 cycles.
526556|NCT00698451|B1|Baseline|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
526557|NCT00698451|P1|Participant Flow|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
526558|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
526559|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
526560|NCT00698451|E1|Reported Event|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
526561|NCT00698204|B3|Baseline|Total|Total of all reporting groups
526562|NCT00698204|B2|Baseline|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
526563|NCT00698204|B1|Baseline|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
526564|NCT00698204|P2|Participant Flow|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
526565|NCT00698204|P1|Participant Flow|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
526566|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
526567|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
526568|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
526569|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
526570|NCT00698204|E2|Reported Event|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
526571|NCT00698204|E1|Reported Event|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
526572|NCT00698139|B4|Baseline|Total|Total of all reporting groups
526573|NCT00698139|B3|Baseline|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
526574|NCT00698139|B2|Baseline|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
526596|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526597|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
526598|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526599|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
526575|NCT00698139|B1|Baseline|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
526576|NCT00698139|P3|Participant Flow|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
526577|NCT00698139|P2|Participant Flow|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
526578|NCT00698139|P1|Participant Flow|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
526579|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
526580|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
526581|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
526582|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
526600|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526601|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
526602|NCT00698035|O1|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526834|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526583|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
526584|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
526585|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
526586|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
526587|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
526588|NCT00698139|E3|Reported Event|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
526589|NCT00698139|E2|Reported Event|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
526590|NCT00698139|E1|Reported Event|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
526591|NCT00698035|B3|Baseline|Total|Total of all reporting groups
526592|NCT00698035|B2|Baseline|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526593|NCT00698035|B1|Baseline|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
526603|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526604|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
526605|NCT00698035|O2|Outcome|E2 by RIA|Additional measurement of baseline and week 4 E2 by RIA
526606|NCT00698035|O1|Outcome|E2 by LC/MS|A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range <10 pg/ml)
526607|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526608|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
526609|NCT00698035|E2|Reported Event|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
526610|NCT00698035|E1|Reported Event|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
526611|NCT00698022|B4|Baseline|Total|Total of all reporting groups
526612|NCT00698022|B3|Baseline|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
526613|NCT00698022|B2|Baseline|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
526614|NCT00698022|B1|Baseline|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
526615|NCT00698022|P3|Participant Flow|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
526616|NCT00698022|P2|Participant Flow|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
526617|NCT00698022|P1|Participant Flow|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
526618|NCT00698022|O3|Outcome|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
526619|NCT00698022|O2|Outcome|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
526620|NCT00698022|O1|Outcome|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
526621|NCT00698022|E3|Reported Event|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
526622|NCT00698022|E2|Reported Event|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
526623|NCT00698022|E1|Reported Event|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
526624|NCT00698009|B1|Baseline|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
526625|NCT00698009|P1|Participant Flow|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
526626|NCT00698009|O1|Outcome|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
526627|NCT00698009|E1|Reported Event|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
526628|NCT00697827|B3|Baseline|Total|Total of all reporting groups
526629|NCT00697827|B2|Baseline|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
526630|NCT00697827|B1|Baseline|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
526631|NCT00697827|P2|Participant Flow|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
526659|NCT00697788|P8|Participant Flow|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
531720|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
526632|NCT00697827|P1|Participant Flow|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
526633|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
526634|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
526635|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
526636|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
526637|NCT00697827|E2|Reported Event|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
526638|NCT00697827|E1|Reported Event|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
526639|NCT00697801|B4|Baseline|Total|Total of all reporting groups
526640|NCT00697801|B3|Baseline|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
526641|NCT00697801|B2|Baseline|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
526642|NCT00697801|B1|Baseline|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
526643|NCT00697801|P3|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
526644|NCT00697801|P2|Participant Flow|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
526645|NCT00697801|P1|Participant Flow|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
526646|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
526647|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
526648|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
526649|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
526650|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
526651|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
526652|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
526653|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
526654|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
526655|NCT00697801|E3|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
526656|NCT00697801|E2|Reported Event|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
526657|NCT00697801|E1|Reported Event|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
526658|NCT00697788|B1|Baseline|Ascending Dose Study|"Ascending doses of dexmedetomidine (as per protocol)~Dexmedetomidine: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5."
526683|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|
526684|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|
526660|NCT00697788|P7|Participant Flow|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
526661|NCT00697788|P6|Participant Flow|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
526662|NCT00697788|P5|Participant Flow|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
526663|NCT00697788|P4|Participant Flow|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
526664|NCT00697788|P3|Participant Flow|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
526665|NCT00697788|P2|Participant Flow|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dose and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
526666|NCT00697788|P1|Participant Flow|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
526667|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
526668|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
526669|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
526670|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
526671|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
526672|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
526673|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dexmedetomidine and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
526674|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
526675|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7.
526676|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6.
526677|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5.
526678|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4.
526679|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3.
526680|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2.
526681|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dexmedetomidine and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study.
526682|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes.
526690|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|"Ascending doses of dexmedetomidine (as per protocol)~Dexmedetomidine: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5."
526691|NCT00697788|O8|Outcome|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr|
526692|NCT00697788|O7|Outcome|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr|
526693|NCT00697788|O6|Outcome|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr|
526694|NCT00697788|O5|Outcome|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|
526695|NCT00697788|O4|Outcome|Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr|
526696|NCT00697788|O3|Outcome|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|
526697|NCT00697788|O2|Outcome|Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion|
526698|NCT00697788|O1|Outcome|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|
526699|NCT00697788|E8|Reported Event|Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes
526700|NCT00697788|E7|Reported Event|Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes
526701|NCT00697788|E6|Reported Event|Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes
526702|NCT00697788|E5|Reported Event|Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes
526703|NCT00697788|E4|Reported Event|Cohort 4: Dexmedetomidine 1.3 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr
526704|NCT00697788|E3|Reported Event|Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes
526705|NCT00697788|E2|Reported Event|Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion|This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes
526706|NCT00697788|E1|Reported Event|Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV|All participants received a dexmedetomidine bolus dose of 1 microgram/kilogram over 10 minutes IV
526707|NCT00697697|B3|Baseline|Total|Total of all reporting groups
526708|NCT00697697|B2|Baseline|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526709|NCT00697697|B1|Baseline|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526710|NCT00697697|P2|Participant Flow|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526711|NCT00697697|P1|Participant Flow|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526712|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526713|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526714|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526715|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526716|NCT00697697|E2|Reported Event|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526717|NCT00697697|E1|Reported Event|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
526718|NCT00697619|B3|Baseline|Total|Total of all reporting groups
526719|NCT00697619|B2|Baseline|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526720|NCT00697619|B1|Baseline|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526721|NCT00697619|P2|Participant Flow|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526722|NCT00697619|P1|Participant Flow|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526723|NCT00697619|O2|Outcome|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526724|NCT00697619|O1|Outcome|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526725|NCT00697619|E2|Reported Event|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526726|NCT00697619|E1|Reported Event|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
526727|NCT00697593|B1|Baseline|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526728|NCT00697593|P1|Participant Flow|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526729|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526730|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526731|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526732|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526733|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526734|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526735|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526736|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526737|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526738|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526739|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526740|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526741|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526742|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526743|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526744|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526745|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526746|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526747|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526748|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526749|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526750|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526751|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526752|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526753|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526754|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526755|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526756|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526835|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526757|NCT00697593|E1|Reported Event|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
526758|NCT00697541|B3|Baseline|Total|Total of all reporting groups
526759|NCT00697541|B2|Baseline|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
526760|NCT00697541|B1|Baseline|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
526761|NCT00697541|P2|Participant Flow|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
526762|NCT00697541|P1|Participant Flow|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
526763|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
526764|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
526765|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
526766|NCT00697541|O1|Outcome|Treatment A - COL-118 Gel + Saline Drops|COL-118 gel + saline drops
526767|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
526768|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
526769|NCT00697541|E2|Reported Event|Treatment B|Vehicle gel + brimonidine drops
526770|NCT00697541|E1|Reported Event|Treatment A|COL-118 gel + saline drops
526771|NCT00697515|B1|Baseline|Entire Study Population|
526772|NCT00697515|P2|Participant Flow|Placebo First|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
526773|NCT00697515|P1|Participant Flow|SPD489 First|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
526774|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
526775|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526776|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526777|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526778|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526779|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526780|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526781|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526782|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526783|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
526784|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526785|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526786|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526787|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
526788|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526789|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526790|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
526791|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526792|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
526793|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526794|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
526795|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526796|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
526797|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
526798|NCT00697515|E2|Reported Event|Placebo|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
526799|NCT00697515|E1|Reported Event|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
526800|NCT00697255|B3|Baseline|Total|Total of all reporting groups
527083|NCT00696696|B1|Baseline|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
526801|NCT00697255|B2|Baseline|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526802|NCT00697255|B1|Baseline|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526803|NCT00697255|P2|Participant Flow|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526804|NCT00697255|P1|Participant Flow|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526805|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526806|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526807|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526808|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526809|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526810|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526811|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526836|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526837|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526812|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526813|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526814|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526815|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526816|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526817|NCT00697255|E2|Reported Event|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526818|NCT00697255|E1|Reported Event|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
526819|NCT00697190|B1|Baseline|All Completed Subjects|All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town.
526820|NCT00697190|P2|Participant Flow|Galyfilcon A/Senofilcon A|galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
526821|NCT00697190|P1|Participant Flow|Senofilcon A/Galyfilcon A|senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
526822|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526823|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526824|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526825|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526826|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526827|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526828|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526829|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526830|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526831|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526832|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526838|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526839|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526840|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526841|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526842|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526843|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526844|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526845|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526846|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526847|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526848|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526849|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526850|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
526851|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
526852|NCT00697190|E2|Reported Event|Galyfilcon A|galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
526853|NCT00697190|E1|Reported Event|Senofilcon A|senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
526854|NCT00697112|B1|Baseline|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526855|NCT00697112|P1|Participant Flow|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526856|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526857|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526858|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526859|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526860|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526954|NCT00696800|B3|Baseline|Total|Total of all reporting groups
527038|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
526861|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526862|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526863|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526864|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526865|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526866|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526867|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526868|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526869|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526870|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526871|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526872|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526873|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
531721|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
526874|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526875|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526876|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526877|NCT00697112|E1|Reported Event|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
526878|NCT00697073|B1|Baseline|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
526879|NCT00697073|P1|Participant Flow|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
526880|NCT00697073|O1|Outcome|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
526881|NCT00697073|E1|Reported Event|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
526882|NCT00696878|B1|Baseline|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526883|NCT00696878|P1|Participant Flow|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
526884|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526885|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526886|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526887|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
531722|NCT00684307|O5|Outcome|VKA INR 2-3|
526888|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526889|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526890|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526891|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526892|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526893|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526894|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526895|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526896|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526897|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526898|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526899|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526900|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526901|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526902|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526903|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526904|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526905|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526906|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526907|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526908|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526909|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526910|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526911|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526912|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526913|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526914|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526915|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526916|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526917|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526918|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526919|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526920|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526921|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526922|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526923|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526924|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526925|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526926|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526927|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526928|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526929|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526930|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526931|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526932|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526933|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526934|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526935|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526936|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526937|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526938|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526939|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526940|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526941|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526942|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526943|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526944|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526945|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526946|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526947|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526948|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526949|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526950|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526951|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526952|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526953|NCT00696878|E1|Reported Event|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
526955|NCT00696800|B2|Baseline|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526956|NCT00696800|B1|Baseline|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526957|NCT00696800|P2|Participant Flow|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526958|NCT00696800|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human Chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
526959|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526960|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526961|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526962|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526963|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526964|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526965|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526966|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527034|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
526967|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526968|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526969|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526970|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526971|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526972|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526973|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526974|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526975|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526976|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526977|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526978|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527035|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527079|NCT00696761|E4|Reported Event|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
526979|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526980|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526981|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526982|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526983|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526984|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526985|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526986|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526987|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526988|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526989|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526990|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527036|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527080|NCT00696761|E3|Reported Event|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
526991|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526992|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526993|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526994|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526995|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526996|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526997|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526998|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
526999|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527000|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527001|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527002|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527037|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527081|NCT00696761|E2|Reported Event|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
527003|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527004|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527005|NCT00696800|E2|Reported Event|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527006|NCT00696800|E1|Reported Event|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
527007|NCT00696787|B4|Baseline|Total|Total of all reporting groups
527008|NCT00696787|B3|Baseline|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
527009|NCT00696787|B2|Baseline|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
527010|NCT00696787|B1|Baseline|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
527011|NCT00696787|P3|Participant Flow|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
527012|NCT00696787|P2|Participant Flow|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
527013|NCT00696787|P1|Participant Flow|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
527014|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
527015|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
527016|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
527017|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
527018|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
527019|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
527020|NCT00696787|E3|Reported Event|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
527021|NCT00696787|E2|Reported Event|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
527022|NCT00696787|E1|Reported Event|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
527023|NCT00696774|B4|Baseline|Total|Total of all reporting groups
527024|NCT00696774|B3|Baseline|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
527025|NCT00696774|B2|Baseline|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527026|NCT00696774|B1|Baseline|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527027|NCT00696774|P3|Participant Flow|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
527028|NCT00696774|P2|Participant Flow|Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527029|NCT00696774|P1|Participant Flow|Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527030|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527031|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527032|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527033|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527039|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527040|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527041|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527042|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527043|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527044|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527045|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527046|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527047|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527048|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527049|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527050|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527051|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527052|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527053|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527054|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527055|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527056|NCT00696774|O1|Outcome|Duloxetine|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks. Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
527057|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527058|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527059|NCT00696774|E3|Reported Event|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
527060|NCT00696774|E2|Reported Event|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
527061|NCT00696774|E1|Reported Event|Duloxetine Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
527062|NCT00696761|B5|Baseline|Total|Total of all reporting groups
527063|NCT00696761|B4|Baseline|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
527064|NCT00696761|B3|Baseline|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
527065|NCT00696761|B2|Baseline|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
527066|NCT00696761|B1|Baseline|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
527067|NCT00696761|P4|Participant Flow|BOOI<20, BCI< 100|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
527068|NCT00696761|P3|Participant Flow|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
527069|NCT00696761|P2|Participant Flow|BOOI≥20, BCI< 100|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
527070|NCT00696761|P1|Participant Flow|BOOI≥20, BCI≥ 100|"Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100~alfuzosin : 10mg, once daily, 12months"
527071|NCT00696761|O4|Outcome|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
527072|NCT00696761|O3|Outcome|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
527073|NCT00696761|O2|Outcome|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
527074|NCT00696761|O1|Outcome|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
527075|NCT00696761|O4|Outcome|BOOI<20, BCI<100|"BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12 months"
527076|NCT00696761|O3|Outcome|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
527077|NCT00696761|O2|Outcome|BOOI≥ 20, BCI<100|"BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
527078|NCT00696761|O1|Outcome|BOOI≥ 20, BCI≥100|"Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
527084|NCT00696696|P1|Participant Flow|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
527085|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
527086|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
527087|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
527088|NCT00696696|E1|Reported Event|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
527089|NCT00696618|B4|Baseline|Total|Total of all reporting groups
527090|NCT00696618|B3|Baseline|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
527091|NCT00696618|B2|Baseline|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
527092|NCT00696618|B1|Baseline|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
527093|NCT00696618|P3|Participant Flow|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
527094|NCT00696618|P2|Participant Flow|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
527095|NCT00696618|P1|Participant Flow|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
527096|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
527097|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
527098|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
527099|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
527100|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
527101|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
527102|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
527103|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
527104|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
527105|NCT00696618|E3|Reported Event|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
527106|NCT00696618|E2|Reported Event|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
527107|NCT00696618|E1|Reported Event|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
527108|NCT00696488|B1|Baseline|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
527109|NCT00696488|P1|Participant Flow|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
527110|NCT00696488|O1|Outcome|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
527135|NCT00696436|P5|Participant Flow|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527769|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527111|NCT00696488|E1|Reported Event|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
527112|NCT00696449|B5|Baseline|Total|Total of all reporting groups
527113|NCT00696449|B4|Baseline|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
527114|NCT00696449|B3|Baseline|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
527115|NCT00696449|B2|Baseline|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
527116|NCT00696449|B1|Baseline|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
527117|NCT00696449|P4|Participant Flow|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
527118|NCT00696449|P3|Participant Flow|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
527119|NCT00696449|P2|Participant Flow|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
527120|NCT00696449|P1|Participant Flow|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
527121|NCT00696449|O4|Outcome|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
527122|NCT00696449|O3|Outcome|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
527123|NCT00696449|O2|Outcome|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
527124|NCT00696449|O1|Outcome|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
527125|NCT00696449|E4|Reported Event|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
527126|NCT00696449|E3|Reported Event|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
527127|NCT00696449|E2|Reported Event|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
527128|NCT00696449|E1|Reported Event|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
527129|NCT00696436|B6|Baseline|Total|Total of all reporting groups
527130|NCT00696436|B5|Baseline|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527131|NCT00696436|B4|Baseline|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527132|NCT00696436|B3|Baseline|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527133|NCT00696436|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527134|NCT00696436|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527136|NCT00696436|P4|Participant Flow|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527137|NCT00696436|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527138|NCT00696436|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527139|NCT00696436|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527140|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527141|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527142|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527143|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527144|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527145|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527146|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527147|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527148|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527149|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527150|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527151|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527152|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527153|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527154|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527155|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527156|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527157|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527158|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527159|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527160|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527161|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527162|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527163|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527164|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527165|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527166|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527167|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527168|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527169|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527170|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527171|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527172|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527173|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527174|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527175|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527176|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527177|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527178|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527179|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527180|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527181|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527182|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527183|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527184|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527185|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527186|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527187|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527188|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527189|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527190|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527191|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527192|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527193|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527194|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527195|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
531723|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
527196|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527197|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527198|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527199|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527200|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527201|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527202|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527203|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527204|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527205|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527206|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527207|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527208|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527209|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527210|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527211|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527212|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527213|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527214|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527215|NCT00696436|E5|Reported Event|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
527216|NCT00696436|E4|Reported Event|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
527217|NCT00696436|E3|Reported Event|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
527218|NCT00696436|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
527219|NCT00696436|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
527220|NCT00696423|B3|Baseline|Total|Total of all reporting groups
527221|NCT00696423|B2|Baseline|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527222|NCT00696423|B1|Baseline|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527223|NCT00696423|P2|Participant Flow|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527224|NCT00696423|P1|Participant Flow|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527225|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527226|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527227|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527228|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527229|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527230|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527231|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527232|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527233|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527234|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527235|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527236|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527237|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527238|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527239|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527240|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527241|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527242|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527243|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527244|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527245|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527246|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527247|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527248|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527249|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527250|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527251|NCT00696423|E2|Reported Event|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
527252|NCT00696423|E1|Reported Event|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
527253|NCT00696410|B3|Baseline|Total|Total of all reporting groups
527254|NCT00696410|B2|Baseline|Controls|"The control group consistent of 10 persons without any known health conditions who provided laboratory samples at a single encounter to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
527255|NCT00696410|B1|Baseline|Zinc Acetate|The intervention group consisted of patients with heart failure. Patients were given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
527256|NCT00696410|P2|Participant Flow|Control|"The control group consistent of 10 persons without any known health conditions who provided laboratory samples at a single encounter to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
527257|NCT00696410|P1|Participant Flow|Zinc Acetate|The intervention group consisted of patients with heart failure. Patients were given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
527258|NCT00696410|O2|Outcome|Health Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup."
527259|NCT00696410|O1|Outcome|CHF Treated With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months.
527260|NCT00696410|O2|Outcome|Health Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
527261|NCT00696410|O1|Outcome|CHF Treated With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months.
527262|NCT00696410|O2|Outcome|Healthy Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls."
527263|NCT00696410|O1|Outcome|CHF Patients With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months.
527264|NCT00696410|O2|Outcome|Health Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup."
527265|NCT00696410|O1|Outcome|CHF Treated With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months.
527324|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
531724|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
527266|NCT00696410|O2|Outcome|Healthy Controls|"The control group consistent of 10 persons without any health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls. A single measure was obtained without further followup."
527267|NCT00696410|O1|Outcome|CHF Patients With Zinc Acetate|The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times a day for 10 months. The intended intervention group was n=40, of which n=38 were enrolled. Of these 38, n=25 completed 10 mo of follow-up.
527268|NCT00696410|E2|Reported Event|Healthy Controls|"The control group consisted of 10 persons without any known health conditions who provided laboratory samples to quantify normal values for the novel labs measured. No intervention was provided to the healthy controls"
527269|NCT00696410|E1|Reported Event|HF Group|The zinc intervention group consisted of patients with heart failure who were provided zinc acetate for 10 months
527270|NCT00696384|B1|Baseline|Azilsartan Medoxomil QD - Open Label Phase|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks. Study medication could have been up-titrated only after participant had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up or down-titrated by 1 dose level per scheduled or unscheduled visit. Baseline characteristics of this Open Label phase population are described in the table below.
527271|NCT00696384|P3|Participant Flow|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg, orally once daily or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
527272|NCT00696384|P2|Participant Flow|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks.
527273|NCT00696384|P1|Participant Flow|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
527274|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
527275|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
527276|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed and other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
527277|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
527278|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
527279|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
527280|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
527281|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
527325|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
531725|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
527282|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
527283|NCT00696384|E3|Reported Event|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for up to 6 weeks.
527284|NCT00696384|E2|Reported Event|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil current dose (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other antihypertensive medications as needed for 6 weeks.
527285|NCT00696384|E1|Reported Event|Azilsartan Medoxomil QD - Open Label|"Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily.. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
527286|NCT00696293|B1|Baseline|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
527287|NCT00696293|P1|Participant Flow|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
527288|NCT00696293|O1|Outcome|Duloxetine + Clinical Management|"Duloxetine + clinical management~NOTE -- THIS WORK WAS CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. THE CLINICALTRIALS.GOV DESCRIPTION OF THE STUDY WAS UPDATED 1/5/16 TO UPDATE THE OPEN LABEL NATURE OF THIS WORK. THIS IS WHAT IS REPORTED HERE AND HAS BEEN PEER REVIEWED AND PUBLISHED.~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
527289|NCT00696293|O1|Outcome|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
527290|NCT00696293|E1|Reported Event|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
527291|NCT00696241|B6|Baseline|Total|Total of all reporting groups
527292|NCT00696241|B5|Baseline|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527293|NCT00696241|B4|Baseline|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527294|NCT00696241|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527295|NCT00696241|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527296|NCT00696241|B1|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527297|NCT00696241|P5|Participant Flow|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527298|NCT00696241|P4|Participant Flow|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527299|NCT00696241|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527300|NCT00696241|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527301|NCT00696241|P1|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527302|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527303|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527304|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527305|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527306|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527307|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527308|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527309|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527310|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527311|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527312|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527313|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527314|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527315|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527316|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527317|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527318|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527319|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527320|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527321|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527322|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527323|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
531726|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
527326|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527327|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527328|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527329|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527330|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527331|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527332|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527333|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527334|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527335|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527336|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527337|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527338|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527339|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527340|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527341|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527342|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527343|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527344|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527345|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527346|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527347|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527348|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527349|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527350|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527351|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527352|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527353|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527354|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527355|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527356|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527357|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527358|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527359|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527360|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527361|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527362|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527363|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527364|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527365|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527366|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527367|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527368|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527369|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527370|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527371|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527372|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527373|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527374|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527375|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527376|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527377|NCT00696241|E5|Reported Event|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
527378|NCT00696241|E4|Reported Event|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
527379|NCT00696241|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
527380|NCT00696241|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
527381|NCT00696241|E1|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
527382|NCT00696072|B3|Baseline|Total|Total of all reporting groups
527383|NCT00696072|B2|Baseline|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
527384|NCT00696072|B1|Baseline|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
527385|NCT00696072|P2|Participant Flow|Letrozole|Participants received letrozole 2.5 mg tablets, once daily, up to 2 years. If the participant developed progressive disease while on the single agent, the participant had the option to add dasatinib to their treatment regimen.
527386|NCT00696072|P1|Participant Flow|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg Tablets, once daily up to 2 years. If a participant experienced intolerable toxicity related to dasatinib, they had the option to crossover to letrozole arm."
527387|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
527388|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
527389|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
527390|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
527391|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
527392|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
527393|NCT00696072|O1|Outcome|Crossed Over From Letrozole to Letrozole + Dasatinib|These participants were randomized to receive letrozole 2.5 mg PO once daily. After developing progressive disease they continued letrozole, and were permitted to add 100 mg PO once daily dasatinib to their treatment regimen.
527394|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
527395|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
527396|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
527397|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
527398|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
527399|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
527400|NCT00696072|E2|Reported Event|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
527401|NCT00696072|E1|Reported Event|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
527402|NCT00696020|B5|Baseline|Total|Total of all reporting groups
527403|NCT00696020|B4|Baseline|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527404|NCT00696020|B3|Baseline|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527654|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527405|NCT00696020|B2|Baseline|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527406|NCT00696020|B1|Baseline|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527407|NCT00696020|P4|Participant Flow|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527408|NCT00696020|P3|Participant Flow|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527409|NCT00696020|P2|Participant Flow|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527410|NCT00696020|P1|Participant Flow|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527411|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527412|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527413|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527414|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527415|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527416|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527417|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527418|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527419|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527420|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527421|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527422|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527423|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527424|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527425|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527426|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527427|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527428|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527429|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527430|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527431|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527432|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527655|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527433|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527434|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527435|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527436|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527437|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527438|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527439|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527440|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527441|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527442|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527443|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527444|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527445|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527446|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527447|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527448|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527449|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527450|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527451|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527452|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527453|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527454|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527455|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527456|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527457|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527458|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527459|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527460|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527461|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527770|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527462|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527463|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527464|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527465|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527466|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527467|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527468|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527469|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527470|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527471|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527472|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527473|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527474|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527475|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527476|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527477|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527478|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527479|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527480|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527481|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527482|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527483|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527484|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527485|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527486|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527487|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527488|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527489|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527490|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527831|NCT00694369|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
527491|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527492|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527493|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527494|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527495|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527496|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527497|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527498|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527499|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527500|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527501|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527502|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527503|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527504|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527505|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527506|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527507|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527508|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527509|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527510|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527511|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527512|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527513|NCT00696020|E4|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527514|NCT00696020|E3|Reported Event|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527515|NCT00696020|E2|Reported Event|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527516|NCT00696020|E1|Reported Event|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
527517|NCT00695955|B1|Baseline|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
527656|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527518|NCT00695955|P1|Participant Flow|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
527519|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
527520|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
527521|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
527522|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
527523|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
527524|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
527525|NCT00695955|E2|Reported Event|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
527526|NCT00695955|E1|Reported Event|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
527527|NCT00695903|B3|Baseline|Total|Total of all reporting groups
527528|NCT00695903|B2|Baseline|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
527529|NCT00695903|B1|Baseline|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
527530|NCT00695903|P2|Participant Flow|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
527531|NCT00695903|P1|Participant Flow|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
527532|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
527533|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
527534|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
527535|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
527536|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
527537|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
527538|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
527539|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
527540|NCT00695903|E2|Reported Event|Vancomycin|Vancomycin 15 mg/kg i.v., dosed to maintain trough serum concentrations of 15 to 20 ug/mL
527541|NCT00695903|E1|Reported Event|Daptomycin|Daptomycin 10 mg/kg i.v.q24hr
527542|NCT00695864|B1|Baseline|Placebo Then Ondansetron|"Dosage and form:~Placebo - tablet Odansetron - 8 mg oral tablet~Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
527543|NCT00695864|P1|Participant Flow|Placebo Then Ondansetron|"Dosage and form:~Placebo - tablet Odansetron - 8 mg oral tablet~Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
527544|NCT00695864|O2|Outcome|Ondansetron|"Ondansetron~Ondansetron and Placebo crossover"
527545|NCT00695864|O1|Outcome|Placebo - Sugar Pill|"Placebo - sugar pill~Ondansetron and Placebo crossover"
527546|NCT00695864|E2|Reported Event|Ondansetron|"Ondansetron~Ondansetron and Placebo crossover"
527547|NCT00695864|E1|Reported Event|Placebo - Sugar Pill|"Placebo - sugar pill~Ondansetron and Placebo crossover"
527548|NCT00695669|B5|Baseline|Total|Total of all reporting groups
527549|NCT00695669|B4|Baseline|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527550|NCT00695669|B3|Baseline|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527551|NCT00695669|B2|Baseline|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527552|NCT00695669|B1|Baseline|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527553|NCT00695669|P4|Participant Flow|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527554|NCT00695669|P3|Participant Flow|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527555|NCT00695669|P2|Participant Flow|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527556|NCT00695669|P1|Participant Flow|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527557|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527558|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527559|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527560|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527561|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527562|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527563|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527564|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527565|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527566|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527567|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527568|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527569|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527570|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527571|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527572|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527573|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527657|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527574|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527575|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527576|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527577|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527578|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527579|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527580|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527581|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527582|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527583|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527584|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527585|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527586|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527587|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527588|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527589|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527590|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527591|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527592|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527593|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527594|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527595|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527596|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527658|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527597|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527598|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527599|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527600|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527601|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527602|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527603|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527604|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527605|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527606|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527607|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527608|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527609|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527610|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527611|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527612|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527613|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527614|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527615|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527616|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527617|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527618|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527619|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527659|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527620|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527621|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527622|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527623|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527624|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527625|NCT00695669|E4|Reported Event|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
527626|NCT00695669|E3|Reported Event|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
527627|NCT00695669|E2|Reported Event|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
527628|NCT00695669|E1|Reported Event|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
527629|NCT00695565|B3|Baseline|Total|Total of all reporting groups
527630|NCT00695565|B2|Baseline|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
527631|NCT00695565|B1|Baseline|Placebo Gel|Placebo Gel is vehicle without clonidine
527632|NCT00695565|P2|Participant Flow|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
527633|NCT00695565|P1|Participant Flow|Placebo Gel|Placebo Gel is vehicle without clonidine
527634|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527635|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527636|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527637|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527638|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527639|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527640|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527641|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527642|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527643|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527644|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527645|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527646|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527647|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527648|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527649|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527650|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527651|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527652|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527653|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527768|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527660|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527661|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
527662|NCT00695565|E2|Reported Event|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
527663|NCT00695565|E1|Reported Event|Placebo Gel|Placebo Gel is vehicle without clonidine
527664|NCT00695500|B3|Baseline|Total|Total of all reporting groups
527665|NCT00695500|B2|Baseline|Placebo|Placebo tablets, 0 mg per day for 3 weeks
527666|NCT00695500|B1|Baseline|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
527667|NCT00695500|P2|Participant Flow|Placebo|Placebo tablets, 0 mg per day for 3 weeks
527668|NCT00695500|P1|Participant Flow|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
527669|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
527670|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
527671|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
527672|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
527673|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
527674|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
527675|NCT00695500|E2|Reported Event|Placebo|Placebo tablets, 0 mg per day for 3 weeks
527676|NCT00695500|E1|Reported Event|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
527677|NCT00695435|B1|Baseline|Overall Study|Overall Study
527678|NCT00695435|P3|Participant Flow|TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%|Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%
527679|NCT00695435|P2|Participant Flow|Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX|Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX
527680|NCT00695435|P1|Participant Flow|TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX|Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX
527681|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
527682|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
527683|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
527684|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
527685|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
527686|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
527687|NCT00695435|E3|Reported Event|TOBRADEX®|TOBRADEX® Ophthalmic Suspension
527688|NCT00695435|E2|Reported Event|TOBREX®|TOBREX® Ophthalmic Solution
527689|NCT00695435|E1|Reported Event|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
527690|NCT00695396|B4|Baseline|Total|Total of all reporting groups
527691|NCT00695396|B3|Baseline|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
527692|NCT00695396|B2|Baseline|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
527693|NCT00695396|B1|Baseline|Placebo|(1ml or 2 mL) subcutaneously once every week
527694|NCT00695396|P3|Participant Flow|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
527695|NCT00695396|P2|Participant Flow|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
527696|NCT00695396|P1|Participant Flow|Placebo|(1ml or 2 mL) subcutaneously once every week
527697|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
527698|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
527699|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
527700|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
527701|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
527702|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
527703|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
527704|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
527705|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
527706|NCT00695396|E3|Reported Event|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
527707|NCT00695396|E2|Reported Event|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
527708|NCT00695396|E1|Reported Event|Placebo|(1ml or 2 mL) subcutaneously once every week
527709|NCT00695318|B3|Baseline|Total|Total of all reporting groups
527710|NCT00695318|B2|Baseline|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye"
527711|NCT00695318|B1|Baseline|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye"
527712|NCT00695318|P2|Participant Flow|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
527713|NCT00695318|P1|Participant Flow|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
527714|NCT00695318|O4|Outcome|A, 2, II 0.5 µg/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
527715|NCT00695318|O3|Outcome|A, 2, II Sham|
527716|NCT00695318|O2|Outcome|A, 2, I 0.2 µg/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
527717|NCT00695318|O1|Outcome|A, 2, I Sham|
527718|NCT00695318|E5|Reported Event|0.5 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection~Systemic AEs"
527719|NCT00695318|E4|Reported Event|0.2 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection~Systemic AEs"
527720|NCT00695318|E3|Reported Event|0.5 ug/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day~Ocular AEs"
527721|NCT00695318|E2|Reported Event|0.2 ug/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day~Ocular AEs"
527722|NCT00695318|E1|Reported Event|Sham Injection|"Sham Injection~Sham Injection: Sham injection~Ocular AEs"
527832|NCT00694369|P1|Participant Flow|Placebo|Placebo orally once daily
527723|NCT00695292|B1|Baseline|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
527724|NCT00695292|P1|Participant Flow|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
527725|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
527726|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
527727|NCT00695292|E1|Reported Event|Intervention|Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
527728|NCT00695188|B3|Baseline|Total|Total of all reporting groups
527729|NCT00695188|B2|Baseline|High Dose|Start with 25 mg MTX per week, administered orally
527730|NCT00695188|B1|Baseline|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
527731|NCT00695188|P2|Participant Flow|High Dose|Start with 25 mg MTX per week, administered orally
527732|NCT00695188|P1|Participant Flow|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
527733|NCT00695188|O2|Outcome|High Dose|Start with 25 mg MTX per week, administered orally
527734|NCT00695188|O1|Outcome|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
527735|NCT00695188|E2|Reported Event|High Dose|Start with 25 mg MTX per week, administered orally
527736|NCT00695188|E1|Reported Event|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
527737|NCT00695136|B1|Baseline|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
527738|NCT00695136|P1|Participant Flow|Open Label Single Arm|"The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study.~Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study."
527739|NCT00695136|O1|Outcome|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
527740|NCT00695136|E1|Reported Event|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
527741|NCT00695097|B3|Baseline|Total|Total of all reporting groups
527742|NCT00695097|B2|Baseline|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only followed up monthly for 1 year.
527743|NCT00695097|B1|Baseline|Rituximab Group|Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed monthly for 1 year.
527744|NCT00695097|P2|Participant Flow|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only and being followed monthly for 1 year.
527745|NCT00695097|P1|Participant Flow|Rituximab Group|Rituximab Group: Rituximab dose is 1000 mg given as an IV infusion every 2 weeks (day 1 and 15) and followed monthly for 1 year.
527746|NCT00695097|O2|Outcome|Control Group|No Rituximab infusion
527747|NCT00695097|O1|Outcome|Rituximab Group|Rituximab infusion day 1 and 15
527748|NCT00695097|E2|Reported Event|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only.
527749|NCT00695097|E1|Reported Event|Rituximab Group|Rituximab Group: Rituximab infusion day 1 and day 14.
527750|NCT00695019|B4|Baseline|Total|Total of all reporting groups
527751|NCT00695019|B3|Baseline|Placebo|placebo lozenges taken 3 times per day
527752|NCT00695019|B2|Baseline|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527753|NCT00695019|B1|Baseline|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
527754|NCT00695019|P3|Participant Flow|Placebo|placebo lozenges taken 3 times per day
527755|NCT00695019|P2|Participant Flow|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527756|NCT00695019|P1|Participant Flow|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
527757|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527758|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527759|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527760|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527761|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527762|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527763|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527764|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527765|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527766|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527767|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527771|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527772|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527773|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527774|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527775|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527776|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527777|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527778|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
527779|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527780|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527781|NCT00695019|E3|Reported Event|Placebo|placebo lozenges taken 3 times per day
527782|NCT00695019|E2|Reported Event|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
527783|NCT00695019|E1|Reported Event|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
527784|NCT00694603|B1|Baseline|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
527785|NCT00694603|P1|Participant Flow|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
527786|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
527787|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
527788|NCT00694603|E1|Reported Event|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
527789|NCT00694564|B1|Baseline|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
527790|NCT00694564|P1|Participant Flow|SAM-e|"This an open-labeled study. All participants received SAM-e.~S-adenosyl methionine : All participants received oral SAM-e which was initiated at a dose of 200 mg daily and escalated by 200 mg every week to a maximum dose of 1400 mg daily if patients did not report significant resolution of abdominal pain (defined as reduction in reported pain and to a maximum frequency of once weekly)."
527791|NCT00694564|O1|Outcome|SAM-e|"This an open-labeled study. All participants will receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
527792|NCT00694564|E1|Reported Event|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
527793|NCT00694551|B4|Baseline|Total|Total of all reporting groups
527794|NCT00694551|B3|Baseline|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527795|NCT00694551|B2|Baseline|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527796|NCT00694551|B1|Baseline|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527797|NCT00694551|P3|Participant Flow|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527798|NCT00694551|P2|Participant Flow|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527799|NCT00694551|P1|Participant Flow|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527800|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527801|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527802|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527803|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527804|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527805|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527806|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527807|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527808|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527809|NCT00694551|E3|Reported Event|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527810|NCT00694551|E2|Reported Event|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527811|NCT00694551|E1|Reported Event|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
527812|NCT00694473|B1|Baseline|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527813|NCT00694473|P1|Participant Flow|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527814|NCT00694473|O1|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527815|NCT00694473|O1|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527816|NCT00694473|O1|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527817|NCT00694473|O1|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527818|NCT00694473|O1|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527819|NCT00694473|O1|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527820|NCT00694473|O1|Outcome|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527821|NCT00694473|E1|Reported Event|Freestyle Navigator|"Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU~Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU"
527822|NCT00694369|B6|Baseline|Total|Total of all reporting groups
527823|NCT00694369|B5|Baseline|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
527824|NCT00694369|B4|Baseline|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
527825|NCT00694369|B3|Baseline|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
527826|NCT00694369|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
527827|NCT00694369|B1|Baseline|Placebo|Placebo orally once daily
527828|NCT00694369|P5|Participant Flow|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
527829|NCT00694369|P4|Participant Flow|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
527830|NCT00694369|P3|Participant Flow|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
527833|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
527834|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
527835|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
527836|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
527837|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
527838|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
527839|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
527840|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
527841|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
527842|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
527843|NCT00694369|E5|Reported Event|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
527844|NCT00694369|E4|Reported Event|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
527845|NCT00694369|E3|Reported Event|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
527846|NCT00694369|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
527847|NCT00694369|E1|Reported Event|Placebo|Placebo orally once daily
527848|NCT00694356|B4|Baseline|Total|Total of all reporting groups
527849|NCT00694356|B3|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527850|NCT00694356|B2|Baseline|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527851|NCT00694356|B1|Baseline|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527852|NCT00694356|P3|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527853|NCT00694356|P2|Participant Flow|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527854|NCT00694356|P1|Participant Flow|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.
527855|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527856|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527857|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527858|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527859|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527860|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527861|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527862|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527863|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527864|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527865|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527892|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527866|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527867|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527868|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527869|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527870|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527871|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527872|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527873|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527874|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527875|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527876|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527877|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527878|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527879|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527880|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527881|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527882|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527883|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527884|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527885|NCT00694356|E3|Reported Event|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527886|NCT00694356|E2|Reported Event|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527887|NCT00694356|E1|Reported Event|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
527888|NCT00694304|B1|Baseline|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527889|NCT00694304|P1|Participant Flow|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527890|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527891|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527893|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527894|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527895|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527896|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527897|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527898|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527899|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
527900|NCT00694304|E1|Reported Event|Vortioxetine 2.5, 5, or 10 mg/Day|
527901|NCT00694161|B1|Baseline|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527902|NCT00694161|P1|Participant Flow|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527903|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527904|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527905|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527906|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527907|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527908|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527909|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527910|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527911|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527912|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527913|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527914|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527915|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
528086|NCT00693628|P2|Participant Flow|No Shrinker|Patients will receive no shrinker
528137|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
527916|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527917|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527918|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527919|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527920|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527921|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527922|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527923|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527924|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527925|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527926|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527927|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527928|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527929|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527930|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527931|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527932|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
528134|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
531727|NCT00684307|E5|Reported Event|VKA INR 2-3|
527933|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527934|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527935|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527936|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527937|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527938|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527939|NCT00694161|E1|Reported Event|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
527940|NCT00694122|B1|Baseline|All Study Participants|"Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied.~If the participant entered the study on NPH, NPH insulin given twice per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on once per day Lantus. Upon the second overnight visit, Lantus insulin and blood glucose outcomes was studied"
527941|NCT00694122|P2|Participant Flow|NPH First, Then Lantus|NPH was given twice per day in the first intervention period for 3-4 weeks and .Lantus was given once per day in second intervention period for 3-4 weeks.
527942|NCT00694122|P1|Participant Flow|Lantus First, Then NPH|Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied
527943|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
527944|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission. .
527945|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
527946|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
527947|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
527948|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given at 22:00 on the evening of the overnight admission.
527949|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
527950|NCT00694122|O1|Outcome|Glargine (Lantus)|glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
527951|NCT00694122|O2|Outcome|NPH Insulin|NPH was the given at 22:00 on the evening of the overnight admission.
527952|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
527953|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
527954|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
527955|NCT00694122|E2|Reported Event|Lantus Insulin|Individuals on Lantus insulin as long acting insulin.
527956|NCT00694122|E1|Reported Event|NPH Insulin|Individuals on NPH insuling as long acting insulin.
527957|NCT00694109|B1|Baseline|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527958|NCT00694109|P1|Participant Flow|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527959|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527960|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
528135|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
527961|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527962|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527963|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) once a week subcutaneously for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527964|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527965|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527966|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527967|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527968|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527969|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527970|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527971|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527972|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527973|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527974|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527975|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527976|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527977|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527978|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527979|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527980|NCT00694109|E1|Reported Event|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
527981|NCT00694096|B1|Baseline|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
527982|NCT00694096|P1|Participant Flow|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
527983|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
527984|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
528138|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
527985|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
527986|NCT00694096|E1|Reported Event|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
527987|NCT00694070|B1|Baseline|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
527988|NCT00694070|P1|Participant Flow|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
527989|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
527990|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
527991|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
527992|NCT00694070|E1|Reported Event|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
527993|NCT00694018|B3|Baseline|Total|Total of all reporting groups
527994|NCT00694018|B2|Baseline|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
527995|NCT00694018|B1|Baseline|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
527996|NCT00694018|P2|Participant Flow|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
527997|NCT00694018|P1|Participant Flow|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
527998|NCT00694018|O2|Outcome|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
527999|NCT00694018|O1|Outcome|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
528000|NCT00694018|E2|Reported Event|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
528001|NCT00694018|E1|Reported Event|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
528002|NCT00693992|B3|Baseline|Total|Total of all reporting groups
528003|NCT00693992|B2|Baseline|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528004|NCT00693992|B1|Baseline|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528005|NCT00693992|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528006|NCT00693992|P1|Participant Flow|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528007|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528008|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528009|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528010|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528011|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528012|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528013|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528139|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528014|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528015|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528016|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528017|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528018|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528019|NCT00693992|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
528020|NCT00693992|E1|Reported Event|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
528021|NCT00693784|B1|Baseline|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
528022|NCT00693784|P1|Participant Flow|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
528023|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
528024|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
528025|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
528026|NCT00693784|E1|Reported Event|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
528027|NCT00693719|B1|Baseline|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
528028|NCT00693719|P1|Participant Flow|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
528029|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
528030|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
528031|NCT00693719|E1|Reported Event|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
528032|NCT00693706|B3|Baseline|Total|Total of all reporting groups
528033|NCT00693706|B2|Baseline|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528034|NCT00693706|B1|Baseline|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528035|NCT00693706|P2|Participant Flow|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528036|NCT00693706|P1|Participant Flow|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528037|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528038|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528039|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528040|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528041|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528042|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528043|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528136|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
528044|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528045|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528046|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528047|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528048|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528049|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528050|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528051|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528052|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528053|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528054|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528055|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528056|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528057|NCT00693706|E2|Reported Event|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528058|NCT00693706|E1|Reported Event|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
528059|NCT00693693|B4|Baseline|Total|Total of all reporting groups
528060|NCT00693693|B3|Baseline|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily
528061|NCT00693693|B2|Baseline|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
528062|NCT00693693|B1|Baseline|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
528063|NCT00693693|P3|Participant Flow|Cream|topical hydrocortisone 17-butyrate 0.1% preparation cream
528064|NCT00693693|P2|Participant Flow|Lipocream|topical hydrocortisone 17-butyrate 0.1% preparation lipocream
528065|NCT00693693|P1|Participant Flow|Ointment|topical hydrocortisone 17-butyrate 0.1% preparation ointment
528066|NCT00693693|O3|Outcome|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily to all areas of atopic dermatitis
528067|NCT00693693|O2|Outcome|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily to all areas of atopic dermatitis
528068|NCT00693693|O1|Outcome|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily to all areas of atopic dermatitis
528069|NCT00693693|E3|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Lipocream|topical hydrocortisone 17-butyrate 0.1% lipocream applied twice daily
528070|NCT00693693|E2|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
528071|NCT00693693|E1|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
528072|NCT00693654|B3|Baseline|Total|Total of all reporting groups
528073|NCT00693654|B2|Baseline|Placebo|Placebo lotion (Cetaphil)
528074|NCT00693654|B1|Baseline|Active|Active Medicated Lotion (Sarna)
528075|NCT00693654|P2|Participant Flow|Placebo Cetaphil Lotion|Placebo lotion (Cetaphil) applied twice daily to areas of pruritus
528076|NCT00693654|P1|Participant Flow|Pramoxine Lotion|Active Medicated Pramoxine Lotion (Sarna) applied topically twice daily to areas of pruritus
528077|NCT00693654|O2|Outcome|Placebo|Placebo lotion (Cetaphil)
528078|NCT00693654|O1|Outcome|Active|Active Medicated Lotion (Sarna)
528079|NCT00693654|O2|Outcome|Placebo|Placebo lotion (Cetaphil)
528080|NCT00693654|O1|Outcome|Active|Active Medicated Pramoxine Lotion (Sarna)
528081|NCT00693654|E2|Reported Event|Placebo|Placebo lotion (Cetaphil)
528082|NCT00693654|E1|Reported Event|Active|Active Medicated Lotion (Sarna)
528083|NCT00693628|B3|Baseline|Total|Total of all reporting groups
528084|NCT00693628|B2|Baseline|No Shrinker|Patients will receive no shrinker
528085|NCT00693628|B1|Baseline|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
528087|NCT00693628|P1|Participant Flow|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
528088|NCT00693628|O2|Outcome|No Shrinker|Patients will receive no shrinker
528089|NCT00693628|O1|Outcome|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
528090|NCT00693628|E2|Reported Event|No Shrinker|Patients will receive no shrinker
528091|NCT00693628|E1|Reported Event|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
528092|NCT00693498|B3|Baseline|Total|Total of all reporting groups
528093|NCT00693498|B2|Baseline|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528094|NCT00693498|B1|Baseline|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528095|NCT00693498|P2|Participant Flow|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528096|NCT00693498|P1|Participant Flow|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528097|NCT00693498|O2|Outcome|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528098|NCT00693498|O1|Outcome|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528099|NCT00693498|O2|Outcome|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528100|NCT00693498|O1|Outcome|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528101|NCT00693498|E2|Reported Event|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528102|NCT00693498|E1|Reported Event|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
528103|NCT00693485|B4|Baseline|Total|Total of all reporting groups
528104|NCT00693485|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528105|NCT00693485|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528106|NCT00693485|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528107|NCT00693485|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528108|NCT00693485|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528109|NCT00693485|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528110|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528111|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528112|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528113|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528114|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528115|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528116|NCT00693485|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528117|NCT00693485|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528118|NCT00693485|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
528119|NCT00693472|B5|Baseline|Total|Total of all reporting groups
528120|NCT00693472|B4|Baseline|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
528121|NCT00693472|B3|Baseline|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528122|NCT00693472|B2|Baseline|Part 1: Placebo|Placebo every 12 hours for 13 days
528123|NCT00693472|B1|Baseline|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528124|NCT00693472|P4|Participant Flow|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
528125|NCT00693472|P3|Participant Flow|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528126|NCT00693472|P2|Participant Flow|Part 1: Placebo|Placebo every 12 hours for 13 days
528127|NCT00693472|P1|Participant Flow|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528128|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
528129|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528130|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
528131|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528132|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
528133|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528140|NCT00693472|E4|Reported Event|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528141|NCT00693472|E3|Reported Event|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
528142|NCT00693472|E2|Reported Event|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
528143|NCT00693472|E1|Reported Event|Part 1: Placebo|Placebo every 12 hours for 13 days
528144|NCT00693420|B3|Baseline|Total|Total of all reporting groups
528145|NCT00693420|B2|Baseline|Vehicle Solution|
528146|NCT00693420|B1|Baseline|Bimatoprost 0.03% Solution|
528147|NCT00693420|P2|Participant Flow|Vehicle Solution|
528148|NCT00693420|P1|Participant Flow|Bimatoprost 0.03% Solution|
528149|NCT00693420|O2|Outcome|Vehicle Solution|
528150|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528151|NCT00693420|O2|Outcome|Vehicle Solution|
528152|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528153|NCT00693420|O2|Outcome|Vehicle Solution|
528154|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528155|NCT00693420|O2|Outcome|Vehicle Solution|
528156|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528157|NCT00693420|O2|Outcome|Vehicle Solution|
528158|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528159|NCT00693420|O2|Outcome|Vehicle Solution|
528160|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528161|NCT00693420|O2|Outcome|Vehicle Solution|
528162|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528163|NCT00693420|O2|Outcome|Vehicle Solution|
528164|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528165|NCT00693420|O2|Outcome|Vehicle Solution|
528166|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528167|NCT00693420|O2|Outcome|Vehicle Solution|
528168|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
528169|NCT00693420|E2|Reported Event|Vehicle Solution|
528170|NCT00693420|E1|Reported Event|Bimatoprost 0.03% Solution|
528171|NCT00693303|B1|Baseline|My Scrivener Training|Children received My Scrivenor training
528172|NCT00693303|P1|Participant Flow|My Scrivener Training|Subjects practiced writing letters and words for 20 minutes two times per week using the My Scrivenor device.
528173|NCT00693303|O1|Outcome|My Scrivener Training|Children received My Scrivenor training
528174|NCT00693303|E1|Reported Event|My Scrivener Training|Children received My Scrivenor training
528175|NCT00693238|B3|Baseline|Total|Total of all reporting groups
528176|NCT00693238|B2|Baseline|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
528177|NCT00693238|B1|Baseline|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
528178|NCT00693238|P2|Participant Flow|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
528179|NCT00693238|P1|Participant Flow|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
528180|NCT00693238|O2|Outcome|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
528181|NCT00693238|O1|Outcome|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
528182|NCT00693238|E2|Reported Event|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
528183|NCT00693238|E1|Reported Event|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
528184|NCT00693225|B3|Baseline|Total|Total of all reporting groups
528185|NCT00693225|B2|Baseline|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
528186|NCT00693225|B1|Baseline|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
528187|NCT00693225|P2|Participant Flow|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
528188|NCT00693225|P1|Participant Flow|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
528189|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
528190|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
528191|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
528192|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
528193|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
528194|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
528195|NCT00693225|E2|Reported Event|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
528196|NCT00693225|E1|Reported Event|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
528197|NCT00693160|B3|Baseline|Total|Total of all reporting groups
528198|NCT00693160|B2|Baseline|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
528199|NCT00693160|B1|Baseline|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
528220|NCT00692913|B2|Baseline|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528221|NCT00692913|B1|Baseline|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528468|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528200|NCT00693160|P2|Participant Flow|Placebo Intrathecal Injection|"In the presence of remifentanil subjects received a single intrathecal injection of placebo (preservative-free normal saline).~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
528201|NCT00693160|P1|Participant Flow|Intrathecal Ketorolac|"In the presence of a remifentanil infusion subjects received a single intrathecal injection of ketorolac 2 mg.~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
528202|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
528203|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
528204|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
528205|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
528206|NCT00693160|E2|Reported Event|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
528207|NCT00693160|E1|Reported Event|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
528208|NCT00693017|B3|Baseline|Total|Total of all reporting groups
528209|NCT00693017|B2|Baseline|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528210|NCT00693017|B1|Baseline|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528211|NCT00693017|P2|Participant Flow|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528212|NCT00693017|P1|Participant Flow|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528213|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528214|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528215|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528216|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528217|NCT00693017|E2|Reported Event|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528218|NCT00693017|E1|Reported Event|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
528219|NCT00692913|B3|Baseline|Total|Total of all reporting groups
528222|NCT00692913|P2|Participant Flow|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528223|NCT00692913|P1|Participant Flow|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528224|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528225|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528226|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528227|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528228|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528229|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528230|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528231|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528232|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528233|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528234|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528235|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528236|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528237|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528238|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528239|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528240|NCT00692913|E2|Reported Event|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
528241|NCT00692913|E1|Reported Event|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
528242|NCT00692770|B3|Baseline|Total|Total of all reporting groups
528243|NCT00692770|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528244|NCT00692770|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528245|NCT00692770|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528246|NCT00692770|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528247|NCT00692770|O2|Outcome|MET Low Expression Group|MET low expression group included participants with the MET expression lower than 182.444 ng/mL.
528248|NCT00692770|O1|Outcome|MET High Expression Group|MET high expression group included participants with the MET expression higher than 182.444 ng/mL.
528249|NCT00692770|O2|Outcome|AFP Low Expression Group|AFP low expression group included participants with the AFP expression lower than 3.899 ng/mL.
528250|NCT00692770|O1|Outcome|AFP High Expression Group|AFP high expression group included participants with the AFP expression higher than 3.899 ng/mL.
528251|NCT00692770|O2|Outcome|ANG-2 Low Expression Group|ANG-2 low expression group included participants with the ANG-2 expression lower than 4009.765 pg/mL.
528252|NCT00692770|O1|Outcome|ANG-2 High Expression Group|ANG-2 high expression group included participants with the ANG-2 expression higher than 4009.765 pg/mL.
528253|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528254|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528255|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528256|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528257|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528258|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528259|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528260|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528261|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528262|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528263|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528264|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528265|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
528266|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
528267|NCT00692770|E2|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID).
528268|NCT00692770|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID).
528269|NCT00692692|B1|Baseline|Both Arms|
528270|NCT00692692|P2|Participant Flow|Standard of Care|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
528271|NCT00692692|P1|Participant Flow|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
528272|NCT00692692|O2|Outcome|Standard of Care|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
528273|NCT00692692|O1|Outcome|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
528274|NCT00692692|O2|Outcome|Standard of Care|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
528275|NCT00692692|O1|Outcome|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
528276|NCT00692692|E2|Reported Event|Standard of Care|standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
528277|NCT00692692|E1|Reported Event|DermaMatrix|experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
528278|NCT00692419|B3|Baseline|Total|Total of all reporting groups
528279|NCT00692419|B2|Baseline|Feedback Intervention|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
528280|NCT00692419|B1|Baseline|Symptom Management Intervention|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
528281|NCT00692419|P2|Participant Flow|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
528282|NCT00692419|P1|Participant Flow|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
528283|NCT00692419|O6|Outcome|Feedback Arm Change in Depression Score|Feedback arm change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
528284|NCT00692419|O5|Outcome|Management Group - Change in Depression Score|Management group - change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
528285|NCT00692419|O4|Outcome|Feedback Group - Change in ED Score|Feedback group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
528286|NCT00692419|O3|Outcome|Management Group - Change in ED Score|Management group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
528287|NCT00692419|O2|Outcome|Feedback Group - Change in Pain Score|Feedback group - change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
528288|NCT00692419|O1|Outcome|Management Arm Change in Pain Score|Management arm change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
528289|NCT00692419|E2|Reported Event|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
528290|NCT00692419|E1|Reported Event|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
528291|NCT00692406|B1|Baseline|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
528292|NCT00692406|P1|Participant Flow|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
528293|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528294|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528295|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528296|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528297|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528298|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528299|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528300|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
528301|NCT00692406|E1|Reported Event|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
528302|NCT00692341|B4|Baseline|Total|Total of all reporting groups
528303|NCT00692341|B3|Baseline|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528304|NCT00692341|B2|Baseline|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528305|NCT00692341|B1|Baseline|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528306|NCT00692341|P3|Participant Flow|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528307|NCT00692341|P2|Participant Flow|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528308|NCT00692341|P1|Participant Flow|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528309|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528310|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528311|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528312|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528313|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528314|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528315|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528458|NCT00691938|E3|Reported Event|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528469|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528316|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528317|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528318|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528319|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528320|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528321|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528322|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528323|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528324|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528325|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528326|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528327|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528328|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528329|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528330|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528331|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528332|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528470|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528333|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528334|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528335|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528336|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528337|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528338|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528339|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528340|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528341|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528342|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528343|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528344|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528345|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528346|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528347|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528348|NCT00692341|E3|Reported Event|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
528459|NCT00691938|E2|Reported Event|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528471|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528349|NCT00692341|E2|Reported Event|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
528350|NCT00692341|E1|Reported Event|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
528351|NCT00692237|B3|Baseline|Total|Total of all reporting groups
528352|NCT00692237|B2|Baseline|Placebo|Placebo 100 mg/day (50 + 25 + 25)
528353|NCT00692237|B1|Baseline|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
528354|NCT00692237|P2|Participant Flow|Placebo|Placebo 100 mg/day (50 + 25 + 25)
528355|NCT00692237|P1|Participant Flow|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
528356|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
528357|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
528358|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
528359|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
528360|NCT00692237|E2|Reported Event|Placebo|Placebo 100 mg/day (50 + 25 + 25)
528361|NCT00692237|E1|Reported Event|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
528362|NCT00692211|B3|Baseline|Total|Total of all reporting groups
528363|NCT00692211|B2|Baseline|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
528364|NCT00692211|B1|Baseline|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
528365|NCT00692211|P2|Participant Flow|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
528366|NCT00692211|P1|Participant Flow|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
528367|NCT00692211|O2|Outcome|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
528368|NCT00692211|O1|Outcome|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
528369|NCT00692211|E2|Reported Event|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
528370|NCT00692211|E1|Reported Event|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
528371|NCT00692198|B3|Baseline|Total|Total of all reporting groups
528372|NCT00692198|B2|Baseline|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest).
528373|NCT00692198|B1|Baseline|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528374|NCT00692198|P2|Participant Flow|No Supplemental Oxygen Therapy (No LTOT)|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528375|NCT00692198|P1|Participant Flow|Supplemental Oxygen Therapy (LTOT)|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528376|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528460|NCT00691938|E1|Reported Event|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528461|NCT00691808|B4|Baseline|Total|Total of all reporting groups
528462|NCT00691808|B3|Baseline|Placebo|Placebo dosing volume-matched and administered once per day
528377|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528378|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528379|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528380|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528381|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528382|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528383|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528384|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528385|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528386|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528387|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528388|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528389|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528390|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528463|NCT00691808|B2|Baseline|Low Dose|120 mg LX6171 oral suspension administered once per day
528464|NCT00691808|B1|Baseline|High Dose|240 mg LX6171 oral suspension administered once per day
528391|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528392|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528393|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528394|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528395|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528396|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528397|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528398|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528399|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528400|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528401|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528402|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
528403|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
528404|NCT00692198|E3|Reported Event|No Supplemental Oxygen|Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.
528405|NCT00692198|E2|Reported Event|Patients Crossing Over to Supplemental Oxygen Therapy|Participants in the No supplemental oxygen therapy group who receive supplemental oxygen therapy during their participation in the trial due to prescription of supplemental oxygen outside the trial or development of severe resting or exercise hypoxemia
528465|NCT00691808|P3|Participant Flow|Placebo|Placebo dosing volume-matched and administered once per day
528406|NCT00692198|E1|Reported Event|Supplemental Oxygen Therapy|Participants will receive treatment with supplemental oxygen therapy. Supplemental oxygen therapy: oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep.
528407|NCT00692185|B3|Baseline|Total|Total of all reporting groups
528408|NCT00692185|B2|Baseline|Placebo|Participants will take matched placebo for 16 weeks.
528409|NCT00692185|B1|Baseline|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
528410|NCT00692185|P2|Participant Flow|Placebo|Participants will take matched placebo for 16 weeks.
528411|NCT00692185|P1|Participant Flow|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
528412|NCT00692185|O2|Outcome|Placebo|Participants will take matched placebo for 16 weeks.
528413|NCT00692185|O1|Outcome|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
528414|NCT00692185|E2|Reported Event|Placebo|Participants will take matched placebo for 16 weeks.
528415|NCT00692185|E1|Reported Event|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
528416|NCT00692003|B3|Baseline|Total|Total of all reporting groups
528417|NCT00692003|B2|Baseline|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528418|NCT00692003|B1|Baseline|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528419|NCT00692003|P2|Participant Flow|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo;~>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528420|NCT00692003|P1|Participant Flow|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528421|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528422|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528423|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528424|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528425|NCT00692003|E2|Reported Event|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528426|NCT00692003|E1|Reported Event|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
528427|NCT00691938|B8|Baseline|Total|Total of all reporting groups
528428|NCT00691938|B7|Baseline|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528429|NCT00691938|B6|Baseline|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528430|NCT00691938|B5|Baseline|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528431|NCT00691938|B4|Baseline|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528432|NCT00691938|B3|Baseline|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528433|NCT00691938|B2|Baseline|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528434|NCT00691938|B1|Baseline|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528435|NCT00691938|P7|Participant Flow|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528436|NCT00691938|P6|Participant Flow|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528437|NCT00691938|P5|Participant Flow|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528438|NCT00691938|P4|Participant Flow|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528439|NCT00691938|P3|Participant Flow|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528440|NCT00691938|P2|Participant Flow|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528441|NCT00691938|P1|Participant Flow|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528442|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528443|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528444|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528445|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528466|NCT00691808|P2|Participant Flow|Low Dose|120 mg LX6171 oral suspension administered once per day
528467|NCT00691808|P1|Participant Flow|High Dose|240 mg LX6171 oral suspension administered once per day
528446|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528447|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528448|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528449|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528450|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528451|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528452|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
528453|NCT00691938|O1|Outcome|Phase I (Includes Levels 1-5)|
528454|NCT00691938|E7|Reported Event|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528455|NCT00691938|E6|Reported Event|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528456|NCT00691938|E5|Reported Event|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528457|NCT00691938|E4|Reported Event|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
528472|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528473|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528474|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528475|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528476|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528477|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528478|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528479|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528480|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528481|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528482|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528483|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528484|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528485|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528486|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528487|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528488|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528489|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528490|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528491|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528492|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528493|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528494|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528495|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528496|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528497|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528498|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528499|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528500|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528501|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
528502|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
528503|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
528504|NCT00691808|E3|Reported Event|Placebo|Placebo dosing volume-matched and administered once per day
528505|NCT00691808|E2|Reported Event|Low Dose|120 mg LX6171 oral suspension administered once per day
528506|NCT00691808|E1|Reported Event|High Dose|240 mg LX6171 oral suspension administered once per day
528507|NCT00691704|B1|Baseline|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Maintenance Therapy: Subjects who achieve >partial response (PR) after induction will receive repeating triplet 28-day cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance:~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on Days 1-7~Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21."
528508|NCT00691704|P1|Participant Flow|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
528509|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
528530|NCT00691652|B1|Baseline|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
528510|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
528511|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
528512|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
528513|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
528514|NCT00691704|E1|Reported Event|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
528515|NCT00691665|B3|Baseline|Total|Total of all reporting groups
528516|NCT00691665|B2|Baseline|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
528517|NCT00691665|B1|Baseline|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
528518|NCT00691665|P2|Participant Flow|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
528519|NCT00691665|P1|Participant Flow|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
528520|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
528521|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
528522|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
528523|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
528524|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
528525|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
528526|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
528527|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
528528|NCT00691665|E2|Reported Event|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
528529|NCT00691665|E1|Reported Event|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
528566|NCT00691301|O1|Outcome|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
528531|NCT00691652|P1|Participant Flow|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
528532|NCT00691652|O1|Outcome|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
528533|NCT00691652|E1|Reported Event|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
528534|NCT00691483|B3|Baseline|Total|Total of all reporting groups
528535|NCT00691483|B2|Baseline|Placebo|Placebo matched to varenicline.
528536|NCT00691483|B1|Baseline|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528537|NCT00691483|P2|Participant Flow|Placebo|Placebo matched to varenicline.
528538|NCT00691483|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528539|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
528540|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528541|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
528542|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528543|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
528544|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528545|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
528546|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528547|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
528548|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528549|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
528550|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528551|NCT00691483|E2|Reported Event|Placebo|Placebo matched to varenicline.
528552|NCT00691483|E1|Reported Event|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
528553|NCT00691327|B3|Baseline|Total|Total of all reporting groups
528554|NCT00691327|B2|Baseline|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
528555|NCT00691327|B1|Baseline|Reconstruction|Women who have undergone Breast Reconstruction
528556|NCT00691327|P2|Participant Flow|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
528557|NCT00691327|P1|Participant Flow|Reconstruction|Women who have undergone Breast Reconstruction
528558|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
528559|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
528560|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
528561|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
528562|NCT00691327|E2|Reported Event|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
528563|NCT00691327|E1|Reported Event|Reconstruction|Women who have undergone Breast Reconstruction
528564|NCT00691301|B1|Baseline|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
528565|NCT00691301|P1|Participant Flow|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
528567|NCT00691301|O1|Outcome|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
528568|NCT00691301|O6|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
528569|NCT00691301|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
528570|NCT00691301|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
528571|NCT00691301|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
528572|NCT00691301|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
528573|NCT00691301|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
528574|NCT00691301|O1|Outcome|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
528575|NCT00691301|E1|Reported Event|Pemetrexed and Cisplatin|"Pemtrexed plus cisplatin on day 1 every 21 days~cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of~pemetrexed disodium"
528576|NCT00691210|B9|Baseline|Total|Total of all reporting groups
528577|NCT00691210|B8|Baseline|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528578|NCT00691210|B7|Baseline|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528579|NCT00691210|B6|Baseline|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528580|NCT00691210|B5|Baseline|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528581|NCT00691210|B4|Baseline|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528582|NCT00691210|B3|Baseline|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528583|NCT00691210|B2|Baseline|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528584|NCT00691210|B1|Baseline|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528585|NCT00691210|P8|Participant Flow|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528586|NCT00691210|P7|Participant Flow|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528587|NCT00691210|P6|Participant Flow|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528588|NCT00691210|P5|Participant Flow|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528589|NCT00691210|P4|Participant Flow|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528590|NCT00691210|P3|Participant Flow|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528591|NCT00691210|P2|Participant Flow|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528592|NCT00691210|P1|Participant Flow|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528593|NCT00691210|O2|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1-2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528594|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1-5|"Vorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528595|NCT00691210|O7|Outcome|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528596|NCT00691210|O6|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528597|NCT00691210|O5|Outcome|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528598|NCT00691210|O4|Outcome|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528599|NCT00691210|O3|Outcome|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528600|NCT00691210|O2|Outcome|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528601|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528602|NCT00691210|E7|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528603|NCT00691210|E6|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
528604|NCT00691210|E5|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528639|NCT00691132|O2|Outcome|PEITC|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in either Period 1 or Period 2.
528605|NCT00691210|E4|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528606|NCT00691210|E3|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528607|NCT00691210|E2|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528608|NCT00691210|E1|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
528609|NCT00691197|B3|Baseline|Total|Total of all reporting groups
528610|NCT00691197|B2|Baseline|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
528611|NCT00691197|B1|Baseline|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
528612|NCT00691197|P2|Participant Flow|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
528613|NCT00691197|P1|Participant Flow|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
528614|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
528615|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
528616|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
528617|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
528618|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
528619|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
528620|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
528621|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
528622|NCT00691197|E2|Reported Event|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
528623|NCT00691197|E1|Reported Event|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
528624|NCT00691132|B3|Baseline|Total|Total of all reporting groups
528625|NCT00691132|B2|Baseline|Placebo - PEITC (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
528626|NCT00691132|B1|Baseline|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
528627|NCT00691132|P2|Participant Flow|Placebo - PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
528628|NCT00691132|P1|Participant Flow|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
528629|NCT00691132|O3|Outcome|GSTM1 and GSTT1 Both Genes Present|GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.
528630|NCT00691132|O2|Outcome|GSTM1 and GSTT1 Only One Gene Present|GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.
528631|NCT00691132|O1|Outcome|GSTM1 and GSTT1 Both Genes Null|GSTM1 & GSTT1 Null: genes for glutathione-S-transferase (GST) M1 & T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.
528632|NCT00691132|O3|Outcome|GSTM1 and GSTT1 Both Genes Present|GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.
528633|NCT00691132|O2|Outcome|GSTM1 and GSTT1 Only One Gene Present|GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.
528634|NCT00691132|O1|Outcome|GSTM1 and GSTT1 Both Genes Null|GSTM1 & GSTT1 Null: genes for glutathione-S-transferase (GST) M1 & T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.
528635|NCT00691132|O2|Outcome|GSTT1 Present|GSTT1 Present: gene for glutathione-S-transferase (GST) T1 (GSTT1), present in one or both alleles, leading to a enzymatic activity.
528636|NCT00691132|O1|Outcome|GSTT1 Null|GSTT1 Null: gene for glutathione-S-transferase (GST) T1 (GSTT1), the homozygous deletion of the gene (GSTT1 null), leading to a lack of corresponding enzymatic activity.
528637|NCT00691132|O2|Outcome|GSTM1 Present|GSTM1 Present: gene for glutathione-S-transferase (GST) M1 (GSTM1), present in one or both alleles, leading to a enzymatic activity.
528638|NCT00691132|O1|Outcome|GSTM1 Null|GSTM1 Null: gene for glutathione-S-transferase (GST) M1 (GSTM1), the homozygous deletion of the gene (GSTM1 null), leading to a lack of corresponding enzymatic activity.
528640|NCT00691132|O1|Outcome|Placebo|Participants receive oral placebo four times daily for 5 days in either Period 1 or Period 2.
528641|NCT00691132|O2|Outcome|Placebo - PEITC|Participants receive oral placebo four times daily for 5 days in Period 1 and oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
528642|NCT00691132|O1|Outcome|PEITC-Placebo|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 1 and oral placebo four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
528643|NCT00691132|E3|Reported Event|PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
528644|NCT00691132|E2|Reported Event|Washout|9 days between treatments
528645|NCT00691132|E1|Reported Event|Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
528646|NCT00691093|B1|Baseline|Fesoterodine 4 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
528647|NCT00691093|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
528648|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 mg or 8 mg
528649|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
528650|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528651|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528652|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528653|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528654|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528655|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528656|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528657|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528658|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528659|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528660|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528661|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528662|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528663|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528664|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528665|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528666|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528667|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528668|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528669|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528670|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528671|NCT00691093|O1|Outcome|All Subjects|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
528672|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
528673|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528674|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528675|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528676|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
528677|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
528678|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
528679|NCT00691093|E1|Reported Event|Fesoterodine 4 mg or 8 mg|All Subjects
528680|NCT00691054|B1|Baseline|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528681|NCT00691054|P1|Participant Flow|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528682|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528683|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528684|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528685|NCT00691054|O1|Outcome|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528686|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
528687|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528688|NCT00691054|E1|Reported Event|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
528689|NCT00691028|B4|Baseline|Total|Total of all reporting groups
528690|NCT00691028|B3|Baseline|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528691|NCT00691028|B2|Baseline|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528692|NCT00691028|B1|Baseline|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528693|NCT00691028|P4|Participant Flow|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
528694|NCT00691028|P3|Participant Flow|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528695|NCT00691028|P2|Participant Flow|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528696|NCT00691028|P1|Participant Flow|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528697|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528698|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528699|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528700|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528701|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528702|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528703|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528704|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528705|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528706|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528707|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528708|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14..
528709|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528710|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14..
528711|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528712|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14..
528713|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528714|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528715|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528716|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528717|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528718|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528719|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528720|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528721|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528722|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528723|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528724|NCT00691028|E4|Reported Event|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
528725|NCT00691028|E3|Reported Event|TA-650 10 mg/kg (Double-blind)|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
528726|NCT00691028|E2|Reported Event|TA-650 6 mg/kg (Double-blind)|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
528727|NCT00691028|E1|Reported Event|TA-650 3 mg/kg (Double-blind)|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
528728|NCT00691015|B1|Baseline|All Participants|"All regimens were analyzed together.~Standard of Care (SOC) Chemotherapy or Standard of Care (SOC) Chemotherapy + total body irradiation~SOC chemotherapy or SOC chemotherapy + total body irradiation (TBI) of one of the following regimens:~Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.~Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.~Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.~Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.~Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.~Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
528729|NCT00691015|P1|Participant Flow|Conditioning Regimen|"Chemotherapy or chemotherapy + total body irradiation~Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens:~Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.~Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.~Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.~Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.~Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.~Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
528730|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528731|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528732|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528733|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528734|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528735|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528736|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528737|NCT00691015|O1|Outcome|All Participants|All regimens were analyzed together.
528738|NCT00691015|E1|Reported Event|Conditioning Regimen|"Chemotherapy or chemotherapy + total body irradiation~Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens:~Regimen I: Patients receive fludarabine phosphate IV and busulfan IV.~Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV.~Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV.~Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV.~Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV.~Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI."
528739|NCT00690924|B1|Baseline|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
528740|NCT00690924|P1|Participant Flow|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
528741|NCT00690924|O1|Outcome|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
528742|NCT00690924|E1|Reported Event|Calcitriol|"calcitriol: Oral~laboratory biomarker analysis: Correlative Study~pharmacological study: Correlative Study"
528743|NCT00690898|B1|Baseline|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528744|NCT00690898|P1|Participant Flow|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528745|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528746|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528747|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528748|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528749|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528750|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528751|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528752|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528753|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528754|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528755|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528756|NCT00690898|E1|Reported Event|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
528757|NCT00690833|B1|Baseline|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
528819|NCT00690755|E5|Reported Event|Group 5|Non-diabetic and Type 2 diabetic
528820|NCT00690755|E4|Reported Event|Group 4|Non-diabetic overweight
528821|NCT00690755|E3|Reported Event|Group 3|Control (non-diabetic)
528758|NCT00690833|P1|Participant Flow|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
528759|NCT00690833|O1|Outcome|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
528760|NCT00690833|E1|Reported Event|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
528761|NCT00690820|B3|Baseline|Total|Total of all reporting groups
528762|NCT00690820|B2|Baseline|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
528763|NCT00690820|B1|Baseline|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
528764|NCT00690820|P2|Participant Flow|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
528765|NCT00690820|P1|Participant Flow|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
528766|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528767|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528768|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528769|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528770|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528771|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528772|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528773|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528774|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528775|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528776|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528777|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528778|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528779|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528780|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528781|NCT00690820|O1|Outcome|Placebo|Placebo treatment
528782|NCT00690820|E2|Reported Event|Pancrelipase|Pancrelipase delayed release 12000 units treatment
528783|NCT00690820|E1|Reported Event|Placebo|Placebo treatment
528784|NCT00690794|B3|Baseline|Total|Total of all reporting groups
528785|NCT00690794|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
528786|NCT00690794|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
528787|NCT00690794|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
528788|NCT00690794|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
528789|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
528790|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
528791|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
528792|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
528793|NCT00690794|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
528794|NCT00690794|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
528795|NCT00690755|B8|Baseline|Total|Total of all reporting groups
528796|NCT00690755|B7|Baseline|Group 7|Non-Diabetic treated with Metformin
528797|NCT00690755|B6|Baseline|Group 6|Impaired glucose tolerance (IGT)
528798|NCT00690755|B5|Baseline|Group 5|Non-Diabetic and Type 2 Diabetic subjected to exercise study
528799|NCT00690755|B4|Baseline|Group 4|Non-Diabetic Overweight
528800|NCT00690755|B3|Baseline|Group 3|Control (non-diabetic)
528801|NCT00690755|B2|Baseline|Group 2|Type 1 Diabetic
528802|NCT00690755|B1|Baseline|Group 1|Type 2 diabetic
528803|NCT00690755|P7|Participant Flow|Group 7|Non-diabetic treated with Metformin
528804|NCT00690755|P6|Participant Flow|Group 6|Impaired glucose tolerance (IGT)
528805|NCT00690755|P5|Participant Flow|Group 5|Non-diabetic and Type 2 diabetic
528806|NCT00690755|P4|Participant Flow|Group 4|Non-diabetic overweight
528807|NCT00690755|P3|Participant Flow|Group 3|Control (non-diabetic)
528808|NCT00690755|P2|Participant Flow|Group 2|Type 1 diabetic
528809|NCT00690755|P1|Participant Flow|Group 1|Type 2 diabetic
528810|NCT00690755|O7|Outcome|Group 7|Non-diabetic treated with Metformin
528811|NCT00690755|O6|Outcome|Group 6|Impaired glucose tolerance (IGT)
528812|NCT00690755|O5|Outcome|Group 5|Non-diabetic and Type 2 diabetic
528813|NCT00690755|O4|Outcome|Group 4|Non-diabetic overweight
528814|NCT00690755|O3|Outcome|Group 3|Control (non-diabetic)
528815|NCT00690755|O2|Outcome|Group 2|Type 1 diabetic
528816|NCT00690755|O1|Outcome|Group 1|Type 2 diabetic
528817|NCT00690755|E7|Reported Event|Group 7|Non-diabetic treated with Metformin
528818|NCT00690755|E6|Reported Event|Group 6|Impaired glucose tolerance (IGT)
528824|NCT00690612|B1|Baseline|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
528825|NCT00690612|P1|Participant Flow|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
528826|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
528827|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
528828|NCT00690612|E1|Reported Event|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
528829|NCT00690573|B1|Baseline|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528830|NCT00690573|P1|Participant Flow|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528831|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528832|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528833|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528834|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528835|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528836|NCT00690573|E1|Reported Event|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
528837|NCT00690495|B3|Baseline|Total|Total of all reporting groups
528838|NCT00690495|B2|Baseline|Propofol 1%|Propofol 1%
528839|NCT00690495|B1|Baseline|Modified Propofol|Modified propofol (Propofol 0.5%)
528840|NCT00690495|P2|Participant Flow|Propofol 1%|Propofol 1%
528841|NCT00690495|P1|Participant Flow|Modified Propofol|Modified propofol (Propofol 0.5%)
528842|NCT00690495|O2|Outcome|Propofol 1%|Propofol 1%
528843|NCT00690495|O1|Outcome|Modified Propofol|Modified propofol (Propofol 0.5%)
528844|NCT00690495|E2|Reported Event|Propofol 1%|Propofol 1%
528845|NCT00690495|E1|Reported Event|Modified Propofol|Modified propofol (Propofol 0.5%)
528846|NCT00690482|B3|Baseline|Total|Total of all reporting groups
528847|NCT00690482|B2|Baseline|Placebo|Placebo Oral tablet, twice daily
528848|NCT00690482|B1|Baseline|AZD1981|AZD1981 Oral tablet, twice daily
528849|NCT00690482|P2|Participant Flow|Placebo|Placebo Oral tablet, twice daily
528850|NCT00690482|P1|Participant Flow|AZD1981|AZD1981 Oral tablet, twice daily
528851|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528852|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528853|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528854|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528855|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528856|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528857|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528858|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528859|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528860|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528861|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528862|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528863|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528864|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528865|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528866|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528867|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528868|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528869|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528870|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528871|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528872|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528873|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528874|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528875|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528876|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528877|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
528878|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
528879|NCT00690482|E2|Reported Event|Placebo|Placebo Oral tablet, twice daily
528880|NCT00690482|E1|Reported Event|AZD1981|AZD1981 Oral tablet, twice daily
528881|NCT00690443|B3|Baseline|Total|Total of all reporting groups
528882|NCT00690443|B2|Baseline|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
528883|NCT00690443|B1|Baseline|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
528884|NCT00690443|P2|Participant Flow|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
528885|NCT00690443|P1|Participant Flow|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
528886|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
528887|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
528888|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
528889|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
528890|NCT00690443|E2|Reported Event|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
528891|NCT00690443|E1|Reported Event|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
528892|NCT00690430|B3|Baseline|Total|Total of all reporting groups
528893|NCT00690430|B2|Baseline|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528894|NCT00690430|B1|Baseline|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528895|NCT00690430|P3|Participant Flow|Extension: Octreotide LAR/Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
528896|NCT00690430|P2|Participant Flow|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528897|NCT00690430|P1|Participant Flow|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528898|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528899|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528900|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528901|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528902|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528903|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528904|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528978|NCT00690339|P1|Participant Flow|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528979|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528905|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528906|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528907|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528908|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528909|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528910|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528911|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528912|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528913|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528914|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528915|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528916|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528917|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528918|NCT00690430|E5|Reported Event|Crossover to Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
528919|NCT00690430|E4|Reported Event|Extension Phase Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528980|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528920|NCT00690430|E3|Reported Event|Extension Phase Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528921|NCT00690430|E2|Reported Event|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
528922|NCT00690430|E1|Reported Event|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
528923|NCT00690378|B3|Baseline|Total|Total of all reporting groups
528924|NCT00690378|B2|Baseline|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528925|NCT00690378|B1|Baseline|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528926|NCT00690378|P2|Participant Flow|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528927|NCT00690378|P1|Participant Flow|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528928|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528929|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528930|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528931|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528932|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528933|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528934|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528935|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528936|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528937|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528938|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528939|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528940|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528941|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528942|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528943|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528944|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528945|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528946|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528947|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528948|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528949|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528950|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528951|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528952|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528953|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528954|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528955|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528956|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528957|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528958|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528959|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528960|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528961|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528962|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528963|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528964|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528965|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528966|NCT00690378|O2|Outcome|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528967|NCT00690378|O1|Outcome|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528968|NCT00690378|E2|Reported Event|Imipenem Cilastatin|Imipenem cilastatin 500mg 4xdaily
528969|NCT00690378|E1|Reported Event|NXL104/CAZ|NXL104 125mg/Ceftazidime 500mg TID
528970|NCT00690339|B5|Baseline|Total|Total of all reporting groups
528971|NCT00690339|B4|Baseline|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528972|NCT00690339|B3|Baseline|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528973|NCT00690339|B2|Baseline|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528974|NCT00690339|B1|Baseline|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528975|NCT00690339|P4|Participant Flow|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528976|NCT00690339|P3|Participant Flow|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528977|NCT00690339|P2|Participant Flow|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528981|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528982|NCT00690339|O1|Outcome|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528983|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528984|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528985|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528986|NCT00690339|O1|Outcome|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528987|NCT00690339|E4|Reported Event|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528988|NCT00690339|E3|Reported Event|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528989|NCT00690339|E2|Reported Event|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528990|NCT00690339|E1|Reported Event|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
528991|NCT00690040|B3|Baseline|Total|Total of all reporting groups
528992|NCT00690040|B2|Baseline|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
528993|NCT00690040|B1|Baseline|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
528994|NCT00690040|P2|Participant Flow|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
528995|NCT00690040|P1|Participant Flow|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
528996|NCT00690040|O2|Outcome|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
528997|NCT00690040|O1|Outcome|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
528998|NCT00690040|E2|Reported Event|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
528999|NCT00690040|E1|Reported Event|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
529000|NCT00689936|B4|Baseline|Total|Total of all reporting groups
529001|NCT00689936|B3|Baseline|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529002|NCT00689936|B2|Baseline|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529003|NCT00689936|B1|Baseline|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529004|NCT00689936|P3|Participant Flow|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529005|NCT00689936|P2|Participant Flow|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
531728|NCT00684307|E4|Reported Event|AZD0837 200 mg bd|
529006|NCT00689936|P1|Participant Flow|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529007|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529008|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529009|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529010|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529011|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529012|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529013|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529176|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
529177|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
529014|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529015|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529016|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529017|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529018|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529019|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529020|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529021|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529178|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
529022|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529023|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529024|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529025|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529026|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529027|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529028|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529029|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529179|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
531729|NCT00684307|E3|Reported Event|AZD0837 450 mg od|
529030|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529031|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529032|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529033|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529034|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529035|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529036|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529037|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529180|NCT00689819|E2|Reported Event|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
529181|NCT00689819|E1|Reported Event|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
529038|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529039|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529040|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529041|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529042|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529043|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529044|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529045|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529182|NCT00689793|B3|Baseline|Total|Total of all reporting groups
531730|NCT00684307|E2|Reported Event|AZD0837 300 mg od|
529046|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529047|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529048|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529049|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529050|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529051|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529052|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529053|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529183|NCT00689793|B2|Baseline|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
529184|NCT00689793|B1|Baseline|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
529054|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529055|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529056|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529057|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529058|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529059|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529060|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529061|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529185|NCT00689793|P2|Participant Flow|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
529186|NCT00689793|P1|Participant Flow|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
531731|NCT00684307|E1|Reported Event|AZD0837 150 mg od|
529062|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529063|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529064|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529065|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529066|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529067|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529068|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529069|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529187|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
529070|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529071|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529072|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529073|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529074|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529075|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529076|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529077|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529188|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
529189|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
529078|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529079|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529080|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529081|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529082|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529083|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529084|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529085|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529190|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
529191|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
534930|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529086|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529087|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529088|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529089|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529090|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529091|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529092|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529093|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529192|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
529094|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529095|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529096|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529097|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529098|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529099|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529100|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529101|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529193|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
529194|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
529102|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529103|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529104|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529105|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529106|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529107|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529108|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529109|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529195|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
529196|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily), during one month.
534931|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529110|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529111|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529112|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529113|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529114|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529115|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529116|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529117|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529197|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
529118|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529119|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529120|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529121|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529122|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529123|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529124|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529125|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529198|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
529199|NCT00689793|E2|Reported Event|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
529126|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529127|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529128|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529129|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529130|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529131|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529132|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529133|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529200|NCT00689793|E1|Reported Event|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
529201|NCT00689611|B3|Baseline|Total|Total of all reporting groups
529903|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529134|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529135|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529136|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529137|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529138|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529139|NCT00689936|O3|Outcome|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529140|NCT00689936|O2|Outcome|Lenalidomide and Dexamethasone Rd18|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529141|NCT00689936|O1|Outcome|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529475|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529142|NCT00689936|E3|Reported Event|Melphalan + Prednisone + Thalidomide (MPT)|Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
529143|NCT00689936|E2|Reported Event|Lenalidomide and Dexamethasone (Rd18)|Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
529144|NCT00689936|E1|Reported Event|Lenalidomide and Low-Dose Dexamethasone (Rd)|Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
529145|NCT00689884|B1|Baseline|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
529146|NCT00689884|P1|Participant Flow|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
529147|NCT00689884|O1|Outcome|Group 1|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
529148|NCT00689884|O1|Outcome|Chemotherapy Plus Pegfilgrastim|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
529149|NCT00689884|E1|Reported Event|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
529150|NCT00689871|B5|Baseline|Total|Total of all reporting groups
529151|NCT00689871|B4|Baseline|Revision-reconstruction|All women implanted for revision of a breast reconstruction
529152|NCT00689871|B3|Baseline|Revision-augmentation|All women implanted for revision of a breast augmentation
529153|NCT00689871|B2|Baseline|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
529154|NCT00689871|B1|Baseline|Primary Augmentation|All women implanted for an indication of primary breast augmentation
529155|NCT00689871|P4|Participant Flow|Revision-reconstruction|All women implanted for revision of a breast reconstruction
529156|NCT00689871|P3|Participant Flow|Revision-augmentation|All women implanted for revision of a breast augmentation
529157|NCT00689871|P2|Participant Flow|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
529158|NCT00689871|P1|Participant Flow|Primary Augmentation|All women implanted for an indication of primary breast augmentation
529159|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
529160|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
529161|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
529162|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
529163|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
529164|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
529165|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
529166|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
529167|NCT00689871|E4|Reported Event|Revision-reconstruction|All women implanted for revision of a breast reconstruction
529168|NCT00689871|E3|Reported Event|Revision-augmentation|All women implanted for revision of a breast augmentation
529169|NCT00689871|E2|Reported Event|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
529170|NCT00689871|E1|Reported Event|Primary Augmentation|All women implanted for an indication of primary breast augmentation
529171|NCT00689819|B3|Baseline|Total|Total of all reporting groups
529172|NCT00689819|B2|Baseline|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
529173|NCT00689819|B1|Baseline|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
529174|NCT00689819|P2|Participant Flow|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
529175|NCT00689819|P1|Participant Flow|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
534932|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529202|NCT00689611|B2|Baseline|Bupropion|"participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
529203|NCT00689611|B1|Baseline|Placebo|"participants received placebo for 9 weeks.~Placebo: Placebo"
529204|NCT00689611|P2|Participant Flow|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks."
529205|NCT00689611|P1|Participant Flow|Placebo|Participants received placebo for 9 weeks.
529206|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
529207|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
529208|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
529209|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
529210|NCT00689611|E2|Reported Event|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
529211|NCT00689611|E1|Reported Event|Placebo|Participants received placebo for 9 weeks.
529212|NCT00689481|B3|Baseline|Total|Total of all reporting groups
529213|NCT00689481|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529214|NCT00689481|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529215|NCT00689481|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529216|NCT00689481|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529217|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529218|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529219|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529220|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529221|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529222|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529223|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529224|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529225|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529226|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529227|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529228|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529229|NCT00689481|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529230|NCT00689481|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529231|NCT00689390|B3|Baseline|Total|Total of all reporting groups
529232|NCT00689390|B2|Baseline|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
529233|NCT00689390|B1|Baseline|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
529234|NCT00689390|P2|Participant Flow|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
529235|NCT00689390|P1|Participant Flow|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
529651|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
529236|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
529237|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
529238|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
529239|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
529240|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
529241|NCT00689390|O1|Outcome|Participants From Boceprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
529242|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
529243|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
529244|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
529245|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
529246|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
529247|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
529248|NCT00689390|E2|Reported Event|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
529249|NCT00689390|E1|Reported Event|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
529250|NCT00689351|B3|Baseline|Total|Total of all reporting groups
529251|NCT00689351|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529252|NCT00689351|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529253|NCT00689351|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529254|NCT00689351|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529255|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529256|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529257|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529258|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529259|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529260|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529261|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
534933|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529262|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529263|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529264|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529265|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529266|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529267|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529268|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529269|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529270|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529271|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529272|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529273|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529274|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529275|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529276|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529277|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529278|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
529279|NCT00689351|E6|Reported Event|Toddler Dose 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC ) 0.5mL dose administered IM at 12 months of age (toddler dose).
529280|NCT00689351|E5|Reported Event|Toddler Dose 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered IM at 12 months of age (toddler dose).
529281|NCT00689351|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
529282|NCT00689351|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
529283|NCT00689351|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
529284|NCT00689351|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
529285|NCT00689338|B1|Baseline|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529286|NCT00689338|P1|Participant Flow|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529287|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529288|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529289|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529290|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529291|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529292|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529293|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529294|NCT00689338|E1|Reported Event|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
529295|NCT00689299|B4|Baseline|Total|Total of all reporting groups
529296|NCT00689299|B3|Baseline|2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F|Active Dose Group B
529297|NCT00689299|B2|Baseline|0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (|Active Dose Group A
529298|NCT00689299|B1|Baseline|Placebo|Placebo - Dose Group C
529299|NCT00689299|P3|Participant Flow|0.21 Units Fel d 1|"Active Dose Group A~From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
529300|NCT00689299|P2|Participant Flow|2.1 Units Fel d 1|"Active Dose Group B~From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
529301|NCT00689299|P1|Participant Flow|Placebo|Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.
529302|NCT00689299|O3|Outcome|2.1 Units Standardized Allergenic Extract, Cat Hair|Dose Group B
529303|NCT00689299|O2|Outcome|0.21 Units Standardized Allergenic Extract, Cat Hair|Dose Group A
529304|NCT00689299|O1|Outcome|Placebo|Dose Group C: placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
529305|NCT00689299|E3|Reported Event|Dose Group B|2.1 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
529306|NCT00689299|E2|Reported Event|Dose Group A|0.21 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
529307|NCT00689299|E1|Reported Event|Dose Group C|placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
529308|NCT00689260|B3|Baseline|Total|Total of all reporting groups
529309|NCT00689260|B2|Baseline|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
529310|NCT00689260|B1|Baseline|Log Aware|Dose Log Aware and Daily Diary Enabled
529311|NCT00689260|P2|Participant Flow|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
529312|NCT00689260|P1|Participant Flow|Log Aware|Dose Log Aware and Daily Diary Enabled
529313|NCT00689260|O3|Outcome|Total|
529314|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
529315|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
529316|NCT00689260|O3|Outcome|Total|
529317|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
529318|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
529319|NCT00689260|O3|Outcome|Total|
529320|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
529321|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
529322|NCT00689260|O3|Outcome|Total|
529323|NCT00689260|O2|Outcome|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
529324|NCT00689260|O1|Outcome|Log Aware|Dose Log Aware and Daily Diary Enabled
529325|NCT00689260|E2|Reported Event|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
529326|NCT00689260|E1|Reported Event|Log Aware|Dose Log Aware and Daily Diary Enabled
529327|NCT00689221|B3|Baseline|Total|Total of all reporting groups
529328|NCT00689221|B2|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529329|NCT00689221|B1|Baseline|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529330|NCT00689221|P2|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529331|NCT00689221|P1|Participant Flow|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529357|NCT00689117|B3|Baseline|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529332|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529333|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529334|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529335|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529336|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529337|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529338|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529339|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529340|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529341|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529342|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529343|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529358|NCT00689117|B2|Baseline|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529344|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529345|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529346|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529347|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529348|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529349|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529350|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529351|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529352|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
529353|NCT00689221|E2|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
529354|NCT00689221|E1|Reported Event|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 will be optional in participants without disease progression, If cilengitide treatment considered beneficial in the opinion of the Investigator,
529355|NCT00689117|B5|Baseline|Total|Total of all reporting groups
529356|NCT00689117|B4|Baseline|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529359|NCT00689117|B1|Baseline|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529360|NCT00689117|P4|Participant Flow|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529361|NCT00689117|P3|Participant Flow|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529362|NCT00689117|P2|Participant Flow|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529363|NCT00689117|P1|Participant Flow|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529364|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529365|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529366|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529367|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529368|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529369|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529370|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529371|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529372|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529373|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529374|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529375|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529376|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529377|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529378|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529379|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529380|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529381|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529382|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529383|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529384|NCT00689117|E4|Reported Event|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529385|NCT00689117|E3|Reported Event|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529386|NCT00689117|E2|Reported Event|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529387|NCT00689117|E1|Reported Event|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
529388|NCT00689104|B5|Baseline|Total|Total of all reporting groups
529389|NCT00689104|B4|Baseline|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529390|NCT00689104|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529391|NCT00689104|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529392|NCT00689104|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529393|NCT00689104|P4|Participant Flow|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529394|NCT00689104|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529395|NCT00689104|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529435|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529396|NCT00689104|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529397|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529398|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529399|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529400|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529401|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529402|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529403|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529404|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529405|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529406|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529407|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529408|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529409|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529410|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529411|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529412|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529413|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529414|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529415|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529416|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529417|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529418|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529419|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529420|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529421|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529422|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529423|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529424|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529425|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529426|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529427|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529428|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529429|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529430|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529431|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529432|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529433|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529434|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
534934|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529436|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529437|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529438|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529439|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529440|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529441|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529442|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529443|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529444|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529445|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529446|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529447|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529448|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529449|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529450|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529451|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529452|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529453|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529454|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529455|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529456|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529457|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529458|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529459|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529460|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529461|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529462|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529463|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529464|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529465|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529466|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529467|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529468|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529469|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529470|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529471|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529472|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529473|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529474|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
534935|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529476|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529477|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529478|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529479|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529480|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529481|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529482|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529483|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529484|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529485|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529486|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529487|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529488|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529489|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529490|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529491|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529492|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529493|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529494|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529495|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529496|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529497|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529498|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529499|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529500|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529501|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529502|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529503|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529504|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529505|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529506|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529507|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529508|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529509|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529510|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529511|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529512|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529513|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529514|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
534936|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529515|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529516|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529517|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529518|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529519|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529520|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529521|NCT00689104|E4|Reported Event|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
529522|NCT00689104|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529523|NCT00689104|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
529524|NCT00689104|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
529525|NCT00689091|B3|Baseline|Total|Total of all reporting groups
529526|NCT00689091|B2|Baseline|Minimum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529527|NCT00689091|B1|Baseline|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529528|NCT00689091|P2|Participant Flow|Minimum Anesthesia Contration Alert|"This group will receive an alert if total MAC (Minimum Anesthesia Concenration) (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529529|NCT00689091|P1|Participant Flow|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529530|NCT00689091|O2|Outcome|Formal Interview Report|at 30 days
529531|NCT00689091|O1|Outcome|Spontaneous Reporting|any time up to 30 days
529532|NCT00689091|O2|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529533|NCT00689091|O1|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529534|NCT00689091|O2|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529535|NCT00689091|O1|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529536|NCT00689091|O2|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529537|NCT00689091|O1|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529538|NCT00689091|O2|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529539|NCT00689091|O1|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529540|NCT00689091|O2|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529541|NCT00689091|O1|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529542|NCT00689091|O2|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529543|NCT00689091|O1|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529544|NCT00689091|E2|Reported Event|Miniumum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529904|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529545|NCT00689091|E1|Reported Event|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
529546|NCT00689052|B3|Baseline|Total|Total of all reporting groups
529547|NCT00689052|B2|Baseline|Pramipexole|Patients receiving pramipexole
529548|NCT00689052|B1|Baseline|Placebo|Patients receiving matching placebo
529549|NCT00689052|P2|Participant Flow|Pramipexole|Patients receive pramipexole in dose up-titration steps
529550|NCT00689052|P1|Participant Flow|Placebo|Patients receive placebo in dose up-titration steps
529551|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529552|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529553|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529554|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529555|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529556|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529557|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529558|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529559|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529560|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529561|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529562|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529563|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529564|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529565|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529566|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529567|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529568|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529569|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529570|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529571|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529572|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529573|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
529574|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529575|NCT00689052|O2|Outcome|Pramipexole|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
529576|NCT00689052|O1|Outcome|Placebo|Placebo tablets, once daily in the evening
529577|NCT00689052|E2|Reported Event|Pramipexole|
529578|NCT00689052|E1|Reported Event|Placebo|
529579|NCT00689026|B3|Baseline|Total|Total of all reporting groups
529580|NCT00689026|B2|Baseline|Control|PEG colon cleansing
529581|NCT00689026|B1|Baseline|Experimental|PEG plus lubiprostone colon cleansing
529582|NCT00689026|P2|Participant Flow|Control|Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.
529583|NCT00689026|P1|Participant Flow|Experimental|Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.
529584|NCT00689026|O2|Outcome|Control|All patients in the control will receive a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy.
529585|NCT00689026|O1|Outcome|Experimental|Lubiprostone: Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4 Liters PEG prep (before and after the 4 Liters PEG prep).
529586|NCT00689026|E2|Reported Event|Control|Patients received a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy
529587|NCT00689026|E1|Reported Event|Treatment|Patients who were given a two doses of lubiprostone with the PEG colon cleansing solution on the day prior the recorded colonoscopy for cleansing grading
529588|NCT00688870|B3|Baseline|Total|Total of all reporting groups
529589|NCT00688870|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529590|NCT00688870|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529591|NCT00688870|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529652|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
529592|NCT00688870|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529593|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529594|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529595|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529596|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529597|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529598|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529599|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529600|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529601|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529602|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529603|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529653|NCT00688740|E2|Reported Event|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
529654|NCT00688740|E1|Reported Event|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
529655|NCT00688701|B4|Baseline|Total|Total of all reporting groups
529905|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529604|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529605|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529606|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529607|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529608|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529609|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529610|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529611|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529612|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529613|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529614|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529615|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529656|NCT00688701|B3|Baseline|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
529657|NCT00688701|B2|Baseline|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
529616|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529617|NCT00688870|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
529618|NCT00688870|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 15 months of age (toddler dose).
529619|NCT00688870|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529620|NCT00688870|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529621|NCT00688870|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529622|NCT00688870|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
529623|NCT00688844|B1|Baseline|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529624|NCT00688844|P1|Participant Flow|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529625|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529626|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529627|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529628|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529629|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529630|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529631|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529632|NCT00688844|E1|Reported Event|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
529633|NCT00688753|B1|Baseline|RAD001 10 mg|two 5 mg tablets of everolimus orally, once daily
529634|NCT00688753|P1|Participant Flow|RAD001|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
529635|NCT00688753|O1|Outcome|RAD001|10 mg/day
529636|NCT00688753|O1|Outcome|RAD001|10 mg/day
529637|NCT00688753|O1|Outcome|RAD001|10 mg/day
529638|NCT00688753|O1|Outcome|RAD001|10 mg/day
529639|NCT00688753|O1|Outcome|RAD001|10 mg/day
529640|NCT00688753|O1|Outcome|RAD001|10 mg/day
529641|NCT00688753|E1|Reported Event|All Patients|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
529642|NCT00688740|B3|Baseline|Total|Total of all reporting groups
529643|NCT00688740|B2|Baseline|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
529644|NCT00688740|B1|Baseline|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
529645|NCT00688740|P2|Participant Flow|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
529646|NCT00688740|P1|Participant Flow|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
529647|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
529648|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
529649|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
529650|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
529658|NCT00688701|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529659|NCT00688701|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
529660|NCT00688701|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
529661|NCT00688701|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
529662|NCT00688701|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
529663|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529664|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529665|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529666|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529667|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529668|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529669|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529670|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529671|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529672|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529673|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529674|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529675|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529676|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529677|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529678|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529679|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529680|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529681|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529682|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529683|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529684|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529685|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529686|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529687|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529688|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529689|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529690|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529691|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529692|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529693|NCT00688701|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
529694|NCT00688701|E5|Reported Event|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
529695|NCT00688701|E4|Reported Event|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
529696|NCT00688701|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
529697|NCT00688701|E2|Reported Event|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo.
529698|NCT00688701|E1|Reported Event|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo.
529699|NCT00688688|B4|Baseline|Total|Total of all reporting groups
529700|NCT00688688|B3|Baseline|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529701|NCT00688688|B2|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529702|NCT00688688|B1|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529703|NCT00688688|P3|Participant Flow|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529704|NCT00688688|P2|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529705|NCT00688688|P1|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529706|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529707|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529708|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529709|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529710|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529711|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529712|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529713|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529714|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529715|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529716|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529717|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529718|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529719|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529720|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529721|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529722|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529723|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529724|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529725|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529726|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529727|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529728|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529729|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529730|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529731|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529732|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529733|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529734|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529735|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529736|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529737|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529738|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529739|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529740|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529741|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529906|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529742|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529743|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529744|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529745|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529746|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529747|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529748|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529749|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529750|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529751|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529752|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529753|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529754|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529755|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529756|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529757|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529758|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529759|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529760|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529761|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529762|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529763|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529764|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529765|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529766|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529767|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529768|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529769|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529770|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529771|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529772|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529773|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529774|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529775|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529776|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529777|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529778|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529779|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529780|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529781|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529782|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529783|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529784|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529785|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529786|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529787|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529788|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529789|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529790|NCT00688688|E3|Reported Event|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
529791|NCT00688688|E2|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
529792|NCT00688688|E1|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
529793|NCT00688662|B3|Baseline|Total|Total of all reporting groups
529794|NCT00688662|B2|Baseline|2. ERCP Without Sphincterotomy|Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy
529795|NCT00688662|B1|Baseline|1. ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting
529796|NCT00688662|P2|Participant Flow|2. ERCP Without Sphincterotomy:|Endoscopic Retrograde CholangioPancreatography (ERCP) without biliary and/or pancreatic sphincterotomy
529797|NCT00688662|P1|Participant Flow|1.ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with biliary and/or pancreatic sphincterotomy
529798|NCT00688662|O2|Outcome|2.ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
529799|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
529800|NCT00688662|O2|Outcome|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
529801|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
529802|NCT00688662|E2|Reported Event|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
529803|NCT00688662|E1|Reported Event|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
529804|NCT00688636|B3|Baseline|Total|Total of all reporting groups
529805|NCT00688636|B2|Baseline|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
529806|NCT00688636|B1|Baseline|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
529807|NCT00688636|P2|Participant Flow|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
529808|NCT00688636|P1|Participant Flow|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
529809|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529810|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529811|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529812|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529813|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529814|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529815|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529816|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529817|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529818|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
529819|NCT00688636|E2|Reported Event|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
529820|NCT00688636|E1|Reported Event|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
529821|NCT00688545|B3|Baseline|Total|Total of all reporting groups
529822|NCT00688545|B2|Baseline|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529849|NCT00688519|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529907|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529823|NCT00688545|B1|Baseline|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529824|NCT00688545|P2|Participant Flow|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529825|NCT00688545|P1|Participant Flow|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529826|NCT00688545|O2|Outcome|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529827|NCT00688545|O1|Outcome|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity
529828|NCT00688545|O2|Outcome|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529829|NCT00688545|O1|Outcome|Celecoxib|Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529830|NCT00688545|E2|Reported Event|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529831|NCT00688545|E1|Reported Event|Celecoxib|Participants who were prescribed celecoxib at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
529832|NCT00688519|B3|Baseline|Total|Total of all reporting groups
529833|NCT00688519|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529834|NCT00688519|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529835|NCT00688519|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529836|NCT00688519|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529837|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529838|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529839|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529840|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529841|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529842|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529843|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529844|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529845|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529846|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529847|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529848|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529902|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529850|NCT00688519|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
529851|NCT00688467|B3|Baseline|Total|Total of all reporting groups
529852|NCT00688467|B2|Baseline|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
529853|NCT00688467|B1|Baseline|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
529854|NCT00688467|P2|Participant Flow|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
529855|NCT00688467|P1|Participant Flow|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
529856|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529857|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529858|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529859|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529860|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529861|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529862|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529863|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529864|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529865|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529866|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529867|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529868|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529869|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529870|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529871|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529872|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529873|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529874|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529875|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529876|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529877|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529878|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529879|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529880|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529881|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529882|NCT00688467|E2|Reported Event|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529883|NCT00688467|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
529884|NCT00688324|B1|Baseline|Baseline Screening|All subjects will have baseline measures
529885|NCT00688324|P1|Participant Flow|Single Arm|"All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated.~Acamprosate: Acamprosate 333mg, ii tablets PO tid x 2 weeks"
529886|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529887|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529888|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529889|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529890|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529891|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529892|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529893|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529894|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529895|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529896|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529897|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529898|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529899|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529900|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529901|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529908|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529909|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529910|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529911|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529912|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529913|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529914|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529915|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529916|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529917|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529918|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529919|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529920|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529921|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529922|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529923|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529924|NCT00688324|O2|Outcome|No ETOH Abuse|No Lifetime History of Alcohol Abuse/Dependence
529925|NCT00688324|O1|Outcome|ETOH Abuse|Lifetime History of Alcohol Abuse/Dependence
529926|NCT00688324|E1|Reported Event|Single Arm|"All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated.~Acamprosate: Acamprosate 333mg, ii tablets PO tid x 2 weeks"
529927|NCT00688259|B3|Baseline|Total|Total of all reporting groups
529928|NCT00688259|B2|Baseline|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529929|NCT00688259|B1|Baseline|Cognitive Behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529930|NCT00688259|P2|Participant Flow|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529931|NCT00688259|P1|Participant Flow|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529932|NCT00688259|O2|Outcome|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529933|NCT00688259|O1|Outcome|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529934|NCT00688259|O2|Outcome|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529935|NCT00688259|O1|Outcome|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529936|NCT00688259|O2|Outcome|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
530128|NCT00687674|E1|Reported Event|Sorafenib + Lenalidomide + Dexamethasone|
530524|NCT00686790|P1|Participant Flow|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
529937|NCT00688259|O1|Outcome|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529938|NCT00688259|O2|Outcome|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529939|NCT00688259|O1|Outcome|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529940|NCT00688259|O2|Outcome|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529941|NCT00688259|O1|Outcome|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529942|NCT00688259|O2|Outcome|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529943|NCT00688259|O1|Outcome|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529944|NCT00688259|E2|Reported Event|Supportive Therapy (ST)|"approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns~ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery"
529945|NCT00688259|E1|Reported Event|Cognitive-behavioral Therapy for Psychosis (CBTp)|"approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.~CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery"
529946|NCT00688155|B5|Baseline|Total|Total of all reporting groups
529947|NCT00688155|B4|Baseline|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
529948|NCT00688155|B3|Baseline|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529949|NCT00688155|B2|Baseline|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
534937|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529950|NCT00688155|B1|Baseline|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
529951|NCT00688155|P4|Participant Flow|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; Lifestyle Interventions and Independence for Elders, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
529952|NCT00688155|P3|Participant Flow|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529953|NCT00688155|P2|Participant Flow|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529954|NCT00688155|P1|Participant Flow|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
529955|NCT00688155|O4|Outcome|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
529956|NCT00688155|O3|Outcome|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529957|NCT00688155|O2|Outcome|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529958|NCT00688155|O1|Outcome|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
534938|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
529959|NCT00688155|O4|Outcome|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
529960|NCT00688155|O3|Outcome|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529961|NCT00688155|O2|Outcome|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529962|NCT00688155|O1|Outcome|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
529963|NCT00688155|O4|Outcome|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
529964|NCT00688155|O3|Outcome|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529965|NCT00688155|O2|Outcome|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529966|NCT00688155|O1|Outcome|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
529967|NCT00688155|E4|Reported Event|Healthy Aging|"The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.~Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly."
530003|NCT00687973|B1|Baseline|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530004|NCT00687973|P2|Participant Flow|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
529968|NCT00688155|E3|Reported Event|Combined Intervention|"The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529969|NCT00688155|E2|Reported Event|Cognitive Training|"The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.~Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6."
529970|NCT00688155|E1|Reported Event|Physical Activity Training|"The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.~Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions."
529971|NCT00688103|B3|Baseline|Total|Total of all reporting groups
529972|NCT00688103|B2|Baseline|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
529973|NCT00688103|B1|Baseline|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
529974|NCT00688103|P2|Participant Flow|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
529975|NCT00688103|P1|Participant Flow|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
529976|NCT00688103|O2|Outcome|ETN+MTX|"etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)~ETN+MTX: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)"
529977|NCT00688103|O1|Outcome|ETN Alone|"etanercept (25mg, twice/week, s.c.)~ETN Alone: etanercept (25 mg, twice/week, s.c.)"
529978|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
529979|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
529980|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
529981|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
529982|NCT00688103|E2|Reported Event|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
529983|NCT00688103|E1|Reported Event|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
529984|NCT00688064|B3|Baseline|Total|Total of all reporting groups
529985|NCT00688064|B2|Baseline|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
529986|NCT00688064|B1|Baseline|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
529987|NCT00688064|P2|Participant Flow|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
529988|NCT00688064|P1|Participant Flow|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
529989|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
529990|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
529991|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
529992|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
529993|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
529994|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
529995|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
529996|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
529997|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
529998|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
529999|NCT00688064|E2|Reported Event|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
530000|NCT00688064|E1|Reported Event|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
530001|NCT00687973|B3|Baseline|Total|Total of all reporting groups
530002|NCT00687973|B2|Baseline|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530129|NCT00687609|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
534939|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530005|NCT00687973|P1|Participant Flow|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530006|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530007|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530008|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530009|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530010|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530011|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530012|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530013|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530014|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530015|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530016|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530017|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530018|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530019|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530020|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530021|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530022|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530023|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530024|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530025|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530026|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530027|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530525|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
530028|NCT00687973|E3|Reported Event|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530029|NCT00687973|E2|Reported Event|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
530030|NCT00687973|E1|Reported Event|Amlodipine 5 mg|Run-in: Amlodipine 5 mg
530031|NCT00687908|B3|Baseline|Total|Total of all reporting groups
530032|NCT00687908|B2|Baseline|Vehicle|Vehicle Gel
530033|NCT00687908|B1|Baseline|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530034|NCT00687908|P2|Participant Flow|Vehicle|Vehicle Gel
530035|NCT00687908|P1|Participant Flow|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530036|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
530037|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530038|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
530039|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530040|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
530041|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530042|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
530043|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530044|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
530045|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530046|NCT00687908|E2|Reported Event|Vehicle|Vehicle Gel
530047|NCT00687908|E1|Reported Event|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
530048|NCT00687856|B1|Baseline|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
530049|NCT00687856|P1|Participant Flow|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
530050|NCT00687856|O1|Outcome|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
530051|NCT00687856|E1|Reported Event|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
530052|NCT00687830|B3|Baseline|Total|Total of all reporting groups
530053|NCT00687830|B2|Baseline|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
530054|NCT00687830|B1|Baseline|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
530055|NCT00687830|P2|Participant Flow|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
530056|NCT00687830|P1|Participant Flow|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
530057|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
530058|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
530059|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
530060|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
530061|NCT00687830|E2|Reported Event|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
530062|NCT00687830|E1|Reported Event|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
530063|NCT00687804|B4|Baseline|Total|Total of all reporting groups
530064|NCT00687804|B3|Baseline|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530065|NCT00687804|B2|Baseline|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530130|NCT00687609|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530131|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530132|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530066|NCT00687804|B1|Baseline|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530067|NCT00687804|P3|Participant Flow|Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530068|NCT00687804|P2|Participant Flow|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530069|NCT00687804|P1|Participant Flow|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530070|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530071|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530072|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530095|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530073|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530074|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530075|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530076|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530077|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530078|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530079|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530118|NCT00687713|O2|Outcome|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
530119|NCT00687713|O1|Outcome|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
530080|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530081|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530082|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530083|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530084|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530085|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530086|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530120|NCT00687713|E2|Reported Event|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
530133|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
534940|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530087|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530088|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530089|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530090|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530091|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530092|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530093|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530094|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530134|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530096|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530097|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530098|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530099|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530100|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530101|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530102|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530103|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530104|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530121|NCT00687713|E1|Reported Event|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
530122|NCT00687674|B1|Baseline|Sorafenib + Lenalidomide + Dexamethasone|
530123|NCT00687674|P1|Participant Flow|Sorafenib + Lenalidomide + Dexamethasone|
530105|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530106|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
530107|NCT00687804|E4|Reported Event|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530108|NCT00687804|E3|Reported Event|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530109|NCT00687804|E2|Reported Event|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy"
530110|NCT00687804|E1|Reported Event|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
530111|NCT00687713|B3|Baseline|Total|Total of all reporting groups
530112|NCT00687713|B2|Baseline|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
530113|NCT00687713|B1|Baseline|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
530114|NCT00687713|P2|Participant Flow|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
530115|NCT00687713|P1|Participant Flow|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
530116|NCT00687713|O2|Outcome|Placebo|"Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
530117|NCT00687713|O1|Outcome|Bupropion|"Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
530124|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
530125|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
530135|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530136|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530137|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530138|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530139|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530140|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530141|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530142|NCT00687609|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
530143|NCT00687544|B1|Baseline|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530144|NCT00687544|P1|Participant Flow|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530145|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530146|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530147|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530148|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530149|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530150|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530151|NCT00687544|E1|Reported Event|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
530152|NCT00687531|B1|Baseline|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530153|NCT00687531|P1|Participant Flow|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530154|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530155|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530156|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530157|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530158|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530159|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530160|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530161|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530162|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530163|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530164|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530165|NCT00687531|E1|Reported Event|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
530166|NCT00687453|B3|Baseline|Total|Total of all reporting groups
530167|NCT00687453|B2|Baseline|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
530168|NCT00687453|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530169|NCT00687453|P2|Participant Flow|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
530170|NCT00687453|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530171|NCT00687453|O2|Outcome|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
530172|NCT00687453|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530173|NCT00687453|E2|Reported Event|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
530174|NCT00687453|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530175|NCT00687440|B1|Baseline|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
530224|NCT00687193|B4|Baseline|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530225|NCT00687193|B3|Baseline|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530176|NCT00687440|P1|Participant Flow|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
530177|NCT00687440|O1|Outcome|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
530178|NCT00687440|E1|Reported Event|Caelyx, Docetaxel, Trastuzumab|
530179|NCT00687401|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
530180|NCT00687401|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
530181|NCT00687401|O2|Outcome|Per Protocol Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
530182|NCT00687401|O1|Outcome|Intent to Treat Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
530183|NCT00687401|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
530184|NCT00687362|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
530185|NCT00687362|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
530186|NCT00687362|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
530187|NCT00687362|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
530188|NCT00687323|B1|Baseline|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530189|NCT00687323|P1|Participant Flow|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530190|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530191|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530192|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530193|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530194|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530195|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530196|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530197|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530198|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
534941|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530199|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530200|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530201|NCT00687323|E1|Reported Event|TEMOZOLOMIDE|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
530202|NCT00687297|B3|Baseline|Total|Total of all reporting groups
530203|NCT00687297|B2|Baseline|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
530204|NCT00687297|B1|Baseline|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
530205|NCT00687297|P2|Participant Flow|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
530206|NCT00687297|P1|Participant Flow|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
530207|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
530208|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
530209|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
530210|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
530211|NCT00687297|O1|Outcome|All Randomized Patients|All patients enrolled in the study
530212|NCT00687297|E3|Reported Event|All Treated Patients - Induction|Adverse events occurring during induction among all treated patients
530213|NCT00687297|E2|Reported Event|Treated on Placebo Maintenance|Adverse events among patients receiving placebo during the maintenance phase of the study
530214|NCT00687297|E1|Reported Event|Treated on Vandetanib Maintenance|Adverse events among patients receiving Vandetanib using the maintenance phase of the study
530215|NCT00687219|B1|Baseline|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
530216|NCT00687219|P1|Participant Flow|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
530217|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
530218|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
530219|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
530220|NCT00687219|E1|Reported Event|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
530221|NCT00687193|B7|Baseline|Total|Total of all reporting groups
530222|NCT00687193|B6|Baseline|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530223|NCT00687193|B5|Baseline|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
534942|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530226|NCT00687193|B2|Baseline|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530227|NCT00687193|B1|Baseline|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530228|NCT00687193|P6|Participant Flow|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530229|NCT00687193|P5|Participant Flow|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530230|NCT00687193|P4|Participant Flow|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530231|NCT00687193|P3|Participant Flow|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530232|NCT00687193|P2|Participant Flow|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530233|NCT00687193|P1|Participant Flow|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530234|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530235|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530236|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530237|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530238|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530239|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530240|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530241|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530242|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530243|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530244|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530245|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530246|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530247|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530248|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530249|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530250|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530251|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530252|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530253|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530254|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530255|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530256|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530257|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530258|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530259|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530260|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530261|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530262|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530263|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530264|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530265|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530266|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530267|NCT00687193|O3|Outcome|CP-690,550 5 mg BID|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530268|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530269|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530270|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530271|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530272|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530273|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530274|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530275|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks
530276|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530277|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530278|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530279|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530280|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530281|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530282|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530283|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530284|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530285|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530286|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530287|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530288|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530289|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530290|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530291|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530292|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530293|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530294|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530295|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530296|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530297|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530298|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530299|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530300|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530301|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530302|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530303|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530304|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530305|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530306|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530307|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530308|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530309|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530310|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530311|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530312|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530313|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530314|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530315|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530316|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530317|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530318|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530319|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530320|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530321|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530322|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530323|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530324|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530325|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530326|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530327|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530328|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530329|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530330|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530331|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530332|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530333|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530334|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530335|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530336|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530337|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530338|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530339|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530340|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530341|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530342|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530343|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530344|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530345|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530346|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530347|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530348|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530349|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530350|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530351|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530352|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530353|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530354|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530355|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530356|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530357|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530358|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530359|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Missing values were not imputed.
530360|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530361|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530362|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530363|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530364|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530365|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530366|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530367|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530368|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530369|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530370|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530371|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530372|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530373|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530374|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530375|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530376|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530505|NCT00686842|O1|Outcome|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
530377|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530378|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530379|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530380|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530381|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530382|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530383|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530384|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530385|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530386|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530387|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530388|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530389|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530390|NCT00687193|E6|Reported Event|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
530391|NCT00687193|E5|Reported Event|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
530392|NCT00687193|E4|Reported Event|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
530393|NCT00687193|E3|Reported Event|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
530394|NCT00687193|E2|Reported Event|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
530395|NCT00687193|E1|Reported Event|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
530396|NCT00687167|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
530397|NCT00687167|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast.
530398|NCT00687167|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast.
530399|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
530400|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
530401|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
530402|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
530403|NCT00687167|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
530404|NCT00687167|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
530405|NCT00687102|B3|Baseline|Total|Total of all reporting groups
530406|NCT00687102|B2|Baseline|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530407|NCT00687102|B1|Baseline|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530506|NCT00686842|E1|Reported Event|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
530408|NCT00687102|P2|Participant Flow|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530409|NCT00687102|P1|Participant Flow|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530410|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530411|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530412|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530413|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530414|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530415|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530416|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530417|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530418|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530419|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530420|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530421|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530422|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530423|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530424|NCT00687102|O2|Outcome|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530425|NCT00687102|O1|Outcome|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530426|NCT00687102|E2|Reported Event|Star Participants Assigned to Raloxifene|"Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.~raloxifene: oral raloxifene plus placebo daily for 5 years"
530427|NCT00687102|E1|Reported Event|Star Participants Assigned to Tamoxifen|"Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment.~tamoxifen: oral tamoxifen plus placebo daily for 5 years"
530428|NCT00687076|B3|Baseline|Total|Total of all reporting groups
530429|NCT00687076|B2|Baseline|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530430|NCT00687076|B1|Baseline|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530431|NCT00687076|P2|Participant Flow|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530432|NCT00687076|P1|Participant Flow|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530433|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530434|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530435|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530436|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530437|NCT00687076|E2|Reported Event|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530438|NCT00687076|E1|Reported Event|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
530439|NCT00686998|B4|Baseline|Total|Total of all reporting groups
530440|NCT00686998|B3|Baseline|Olanzapine|Olanzapine 15 mg
530441|NCT00686998|B2|Baseline|Placebo|Matching Placebo
530442|NCT00686998|B1|Baseline|AZD2624|AZD2624 40 mg
530443|NCT00686998|P3|Participant Flow|Olanzapine|Olanzapine 15 mg
530444|NCT00686998|P2|Participant Flow|Placebo|Matching Placebo
530445|NCT00686998|P1|Participant Flow|AZD2624|AZD2624 40 mg
530446|NCT00686998|O3|Outcome|Olanzapine|Olanzapine 15 mg
530447|NCT00686998|O2|Outcome|Placebo|Placebo
530448|NCT00686998|O1|Outcome|AZD2624|AZD2624 40 mg
530449|NCT00686998|E3|Reported Event|Olanzapine|Olanzapine 15 mg
530450|NCT00686998|E2|Reported Event|Placebo|Matching Placebo
530451|NCT00686998|E1|Reported Event|AZD2624|AZD2624 40 mg
530452|NCT00686972|B1|Baseline|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
530453|NCT00686972|P1|Participant Flow|Glucagon Like Peptide 1 -GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
530454|NCT00686972|O1|Outcome|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
530455|NCT00686972|E1|Reported Event|GLP-1|"5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.~GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period."
530456|NCT00686959|B3|Baseline|Total|Total of all reporting groups
530457|NCT00686959|B2|Baseline|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530458|NCT00686959|B1|Baseline|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530459|NCT00686959|P2|Participant Flow|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530460|NCT00686959|P1|Participant Flow|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.~Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530461|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530462|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530463|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530464|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530507|NCT00686803|B4|Baseline|Total|Total of all reporting groups
530508|NCT00686803|B3|Baseline|Placebo|Placebo
530509|NCT00686803|B2|Baseline|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
530510|NCT00686803|B1|Baseline|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
530511|NCT00686803|P3|Participant Flow|Placebo|Placebo
530512|NCT00686803|P2|Participant Flow|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
530513|NCT00686803|P1|Participant Flow|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
530514|NCT00686803|O3|Outcome|Placebo|Placebo
530465|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530466|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530467|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530468|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530469|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530470|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530471|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530472|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530515|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
530516|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
530517|NCT00686803|O3|Outcome|Placebo|Placebo
530518|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
530519|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
530520|NCT00686803|E3|Reported Event|Placebo|Placebo
530521|NCT00686803|E2|Reported Event|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
530522|NCT00686803|E1|Reported Event|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
530523|NCT00686790|B1|Baseline|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
530473|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
530474|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
530475|NCT00686959|E2|Reported Event|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase"
530476|NCT00686959|E1|Reported Event|Arm A:|"Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT (”Concurrent Phase”) for three 21-day cycles, followed by a 3-5 week “Recovery Period,” then treated with consolidation chemotherapy with pemetrexed (”Consolidation Phase”) for four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles."
530477|NCT00686894|B1|Baseline|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
530478|NCT00686894|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
530479|NCT00686894|O1|Outcome|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
530480|NCT00686894|E1|Reported Event|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
530481|NCT00686881|B3|Baseline|Total|Total of all reporting groups
530482|NCT00686881|B2|Baseline|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
530483|NCT00686881|B1|Baseline|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
530484|NCT00686881|P2|Participant Flow|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
530485|NCT00686881|P1|Participant Flow|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
530486|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
530487|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
530488|NCT00686881|O2|Outcome|SNMC|Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
530489|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
530490|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
530491|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
530492|NCT00686881|E2|Reported Event|SNMC|"Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up~to 156 weeks."
530493|NCT00686881|E1|Reported Event|PegIFN-2b|"Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for~up to 156 weeks."
530494|NCT00686855|B3|Baseline|Total|Total of all reporting groups
530495|NCT00686855|B2|Baseline|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
530496|NCT00686855|B1|Baseline|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
530497|NCT00686855|P2|Participant Flow|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
530498|NCT00686855|P1|Participant Flow|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
530499|NCT00686855|O2|Outcome|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
530500|NCT00686855|O1|Outcome|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
530501|NCT00686855|E2|Reported Event|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
530502|NCT00686855|E1|Reported Event|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
530503|NCT00686842|B1|Baseline|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
530504|NCT00686842|P1|Participant Flow|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
530526|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
530527|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
530528|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
530529|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
530530|NCT00686790|E1|Reported Event|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
530531|NCT00686777|B1|Baseline|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
530532|NCT00686777|P1|Participant Flow|Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
530533|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
530534|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
530535|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
530536|NCT00686777|E1|Reported Event|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
530537|NCT00686725|B3|Baseline|Total|Total of all reporting groups
530538|NCT00686725|B2|Baseline|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530539|NCT00686725|B1|Baseline|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530540|NCT00686725|P2|Participant Flow|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530541|NCT00686725|P1|Participant Flow|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530542|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530543|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530544|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530608|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530545|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530546|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530547|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530548|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530549|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530550|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530551|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530552|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530553|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530554|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
534943|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530555|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530556|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530557|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530558|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530559|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
530560|NCT00686725|E2|Reported Event|Temozolomide Alone, Then Temozolomide Radiation|Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
530561|NCT00686725|E1|Reported Event|Temozolomide Radiation|Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
530562|NCT00686712|B4|Baseline|Total|Total of all reporting groups
530563|NCT00686712|B3|Baseline|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
530564|NCT00686712|B2|Baseline|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
530565|NCT00686712|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530566|NCT00686712|P3|Participant Flow|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
530567|NCT00686712|P2|Participant Flow|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
530568|NCT00686712|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530569|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
530570|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
530571|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
530572|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
531017|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
530573|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
530574|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
530575|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
530576|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
530577|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
530578|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
530579|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
530580|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
530581|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
530582|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
530583|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
530584|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
530585|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
530586|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
530587|NCT00686712|O3|Outcome|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
530588|NCT00686712|O2|Outcome|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
530589|NCT00686712|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530590|NCT00686712|E3|Reported Event|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
530591|NCT00686712|E2|Reported Event|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
530592|NCT00686712|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
530593|NCT00686699|B3|Baseline|Total|Total of all reporting groups
530594|NCT00686699|B2|Baseline|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
530595|NCT00686699|B1|Baseline|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule BID for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
530596|NCT00686699|P2|Participant Flow|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
530597|NCT00686699|P1|Participant Flow|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
530598|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530599|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530600|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530601|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530602|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530603|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530604|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530605|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530606|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530607|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530609|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530610|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530611|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530612|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530613|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530614|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530615|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530616|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530617|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530618|NCT00686699|E2|Reported Event|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
530619|NCT00686699|E1|Reported Event|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
530620|NCT00686686|B1|Baseline|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530621|NCT00686686|P1|Participant Flow|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530622|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530623|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530624|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530625|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530626|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530627|NCT00686686|E1|Reported Event|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
530628|NCT00686647|B1|Baseline|AngioSculpt Device|
530629|NCT00686647|P1|Participant Flow|AngioSculpt Device|
530630|NCT00686647|O1|Outcome|AngioSculpt Device|
530631|NCT00686647|O1|Outcome|AngioSculpt Device|
530632|NCT00686647|O1|Outcome|Overall Study|
530633|NCT00686647|E1|Reported Event|AngioSculpt Device|
530634|NCT00686634|B1|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg once daily
530635|NCT00686634|P1|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg orally once daily
530636|NCT00686634|O1|Outcome|Sitagliptin|Any adverse events while receiving sitagliptin
530637|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
530638|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
530639|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
530640|NCT00686634|E1|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg once daily
530641|NCT00686595|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530642|NCT00686595|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530643|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530644|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530645|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530646|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530647|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530648|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530649|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530650|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530651|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530652|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530653|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530654|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530655|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530656|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530657|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
531558|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
530658|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530659|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530660|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530661|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530662|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530663|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530664|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530665|NCT00686595|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
530666|NCT00686543|B5|Baseline|Total|Total of all reporting groups
530667|NCT00686543|B4|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
530668|NCT00686543|B3|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
530669|NCT00686543|B2|Baseline|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
530670|NCT00686543|B1|Baseline|Not Randomized|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8).
530671|NCT00686543|P4|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
530672|NCT00686543|P3|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg Twice a Day (BID) on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
530673|NCT00686543|P2|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
530674|NCT00686543|P1|Participant Flow|Not Randomized|Posaconazole oral suspension (POS) 200 mg Three Times a Day (TID) on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8)
530675|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
530676|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
530677|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
530678|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
530679|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
530680|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
530681|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
530682|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
530683|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
530684|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
530685|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
530686|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
530687|NCT00686543|E4|Reported Event|POS 400 mg TID on Days 9-15|POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.
530688|NCT00686543|E3|Reported Event|POS 400 mg BID on Days 9-15|POS 400 mg on Days 9-15, administered with food or oral nutritional supplements.
530689|NCT00686543|E2|Reported Event|POS 200 mg TID on Days 9-15|POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements.
530690|NCT00686543|E1|Reported Event|POS 200 mg TID on Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements.
530691|NCT00686517|B4|Baseline|Total|Total of all reporting groups
530692|NCT00686517|B3|Baseline|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530693|NCT00686517|B2|Baseline|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530694|NCT00686517|B1|Baseline|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530695|NCT00686517|P3|Participant Flow|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530696|NCT00686517|P2|Participant Flow|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530697|NCT00686517|P1|Participant Flow|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530698|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530699|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530700|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530701|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530702|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530703|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530704|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530705|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530706|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530707|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530708|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530709|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530710|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530711|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530712|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530713|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530714|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530715|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530716|NCT00686517|E3|Reported Event|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
530717|NCT00686517|E2|Reported Event|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
530718|NCT00686517|E1|Reported Event|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
530719|NCT00686374|B1|Baseline|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530720|NCT00686374|P1|Participant Flow|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530721|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530722|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530723|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530724|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530725|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530726|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530727|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530728|NCT00686374|O1|Outcome|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530729|NCT00686374|E1|Reported Event|Any Adalimumab|Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
530730|NCT00686335|B1|Baseline|Safety Population|all patients that started the run-in period with Cortancyl®
530731|NCT00686335|P1|Participant Flow|Safety Population|all patients that started the run-in period with Cortancyl®
530732|NCT00686335|O2|Outcome|Cortancyl|immediate release prednisone
530733|NCT00686335|O1|Outcome|Lodotra|modified release prednisone
530734|NCT00686335|E2|Reported Event|Cortancyl|immediate release prednisone
530735|NCT00686335|E1|Reported Event|Lodotra|modified release prednisone
530736|NCT00686257|B3|Baseline|Total|Total of all reporting groups
530737|NCT00686257|B2|Baseline|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
530738|NCT00686257|B1|Baseline|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
530739|NCT00686257|P2|Participant Flow|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
530740|NCT00686257|P1|Participant Flow|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
530741|NCT00686257|O2|Outcome|Total Face Mask|Received Total Face Mask
530742|NCT00686257|O1|Outcome|Control|Received standard face mask
530743|NCT00686257|E2|Reported Event|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
530744|NCT00686257|E1|Reported Event|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
530745|NCT00686231|B4|Baseline|Total|Total of all reporting groups
530746|NCT00686231|B3|Baseline|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
530747|NCT00686231|B2|Baseline|Lidocaine|Lidocaine 1 inch
530748|NCT00686231|B1|Baseline|Placebo|Sorbolene cream
530749|NCT00686231|P3|Participant Flow|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
530750|NCT00686231|P2|Participant Flow|Lidocaine|Lidocaine 1 inch
530751|NCT00686231|P1|Participant Flow|Placebo|Sorbolene cream
530752|NCT00686231|O3|Outcome|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
530753|NCT00686231|O2|Outcome|Lidocaine|Lidocaine 1 inch
530754|NCT00686231|O1|Outcome|Placebo|Sorbolene cream
530755|NCT00686231|E3|Reported Event|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
530756|NCT00686231|E2|Reported Event|Lidocaine|Lidocaine 1 inch
530757|NCT00686231|E1|Reported Event|Placebo|Sorbolene cream
530758|NCT00686205|B3|Baseline|Total|Total of all reporting groups
530759|NCT00686205|B2|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
530760|NCT00686205|B1|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
530761|NCT00686205|P2|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
530762|NCT00686205|P1|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
530763|NCT00686205|O1|Outcome|HIV Positive Samples|Known HIV-1 or HIV-2 positive samples were used. Samples were determined to be positive by HIV-1 or HIV-2 western blot.
530764|NCT00686205|O1|Outcome|HIV Negative Donors|Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test
530765|NCT00686205|E2|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
530766|NCT00686205|E1|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
530767|NCT00686166|B1|Baseline|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
530768|NCT00686166|P1|Participant Flow|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
530769|NCT00686166|O3|Outcome|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
530770|NCT00686166|O2|Outcome|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
530771|NCT00686166|O1|Outcome|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
534944|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530772|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
530773|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
530774|NCT00686166|E3|Reported Event|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
530775|NCT00686166|E2|Reported Event|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
530776|NCT00686166|E1|Reported Event|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
530777|NCT00686127|B3|Baseline|Total|Total of all reporting groups
530778|NCT00686127|B2|Baseline|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
530779|NCT00686127|B1|Baseline|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
530780|NCT00686127|P2|Participant Flow|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
530781|NCT00686127|P1|Participant Flow|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.
530782|NCT00686127|O2|Outcome|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
530783|NCT00686127|O1|Outcome|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
530784|NCT00686127|E2|Reported Event|Placebo Patch|Placebo patch: Patch is changed every 24 hours
530785|NCT00686127|E1|Reported Event|Lidocaine Patch|Lidocaine patch One patch is changed every twenty-four hours
530786|NCT00686075|B11|Baseline|Total|Total of all reporting groups
530787|NCT00686075|B10|Baseline|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530788|NCT00686075|B9|Baseline|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530789|NCT00686075|B8|Baseline|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530790|NCT00686075|B7|Baseline|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530791|NCT00686075|B6|Baseline|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530792|NCT00686075|B5|Baseline|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530793|NCT00686075|B4|Baseline|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530794|NCT00686075|B3|Baseline|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530795|NCT00686075|B2|Baseline|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530796|NCT00686075|B1|Baseline|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530797|NCT00686075|P10|Participant Flow|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530798|NCT00686075|P9|Participant Flow|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530799|NCT00686075|P8|Participant Flow|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530800|NCT00686075|P7|Participant Flow|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530801|NCT00686075|P6|Participant Flow|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530802|NCT00686075|P5|Participant Flow|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530803|NCT00686075|P4|Participant Flow|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530804|NCT00686075|P3|Participant Flow|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530805|NCT00686075|P2|Participant Flow|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530806|NCT00686075|P1|Participant Flow|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530807|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530808|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530809|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530810|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530811|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530812|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530813|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530814|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530815|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530816|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530817|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530818|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530819|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530820|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530821|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530822|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530823|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530824|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530825|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530826|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530827|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530828|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530829|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530830|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530831|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530832|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530833|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530834|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530835|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530836|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530837|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530838|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530839|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530840|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530841|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530842|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530843|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530844|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530845|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530846|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530847|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530848|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530849|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530850|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530851|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530852|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530853|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530854|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530855|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530856|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530857|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530858|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530859|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530860|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530861|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530862|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530863|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530864|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530865|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530866|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530867|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530868|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530869|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530870|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530871|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530872|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530873|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530874|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530875|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530876|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530877|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530878|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530879|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530880|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530881|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530882|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530883|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530884|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530885|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530886|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530887|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
534945|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530888|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530889|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530890|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530891|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530892|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530893|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530894|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530895|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530896|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530897|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530898|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530899|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530900|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530901|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530902|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530903|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530904|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530905|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530906|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530907|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530908|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530909|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530910|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530911|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530912|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530913|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530914|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530915|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530916|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530917|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530918|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530919|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530920|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530921|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530922|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530923|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530924|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530925|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530926|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530927|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530928|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
534946|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530929|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530930|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530931|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530932|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530933|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530934|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530935|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530936|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530937|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530938|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530939|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530940|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530941|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530942|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530943|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530944|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530945|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530946|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530947|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530948|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530949|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530950|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530951|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530952|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530953|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530954|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530955|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530956|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530957|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530958|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530959|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530960|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530961|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530962|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530963|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530964|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530965|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530966|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530967|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530968|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530969|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
534947|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
530970|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530971|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530972|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530973|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530974|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530975|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530976|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530977|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530978|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530979|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530980|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530981|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530982|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530983|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530984|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530985|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530986|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530987|NCT00686075|E10|Reported Event|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530988|NCT00686075|E9|Reported Event|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530989|NCT00686075|E8|Reported Event|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530990|NCT00686075|E7|Reported Event|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530991|NCT00686075|E6|Reported Event|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530992|NCT00686075|E5|Reported Event|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
530993|NCT00686075|E4|Reported Event|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530994|NCT00686075|E3|Reported Event|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
530995|NCT00686075|E2|Reported Event|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
530996|NCT00686075|E1|Reported Event|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
530997|NCT00686036|B3|Baseline|Total|Total of all reporting groups
530998|NCT00686036|B2|Baseline|Placebo|Placebo to match vandetanib 300 mg tablet
530999|NCT00686036|B1|Baseline|Vandetanib|Vandetanib 300 mg tablet
531000|NCT00686036|P2|Participant Flow|Placebo|Placebo to match vandetanib 300 mg tablet
531001|NCT00686036|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet
531002|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
531003|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
531004|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
531005|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
531006|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
531007|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
531008|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
531009|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
531010|NCT00686036|E2|Reported Event|Placebo|Placebo to match vandetanib 300 mg tablet
531011|NCT00686036|E1|Reported Event|Vandetanib|Vandetanib 300 mg tablet
531012|NCT00685945|B1|Baseline|All Participants|Subjects characteristics for all 24 participants
531013|NCT00685945|P1|Participant Flow|All Participants|24 subjects received a bradykinin infusion and then a bradykinin + L-NMMA infusion. Subjects were then randomized to receive either isosorbide (N=12) or sildenafil (N=12). The infusion of bradykinin + L-NMMA was then repeated.
531014|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
531015|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
531016|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
531018|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
531019|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
531020|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
531021|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
531022|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve of the twenty-four subjects were randomized to sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
531023|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Eleven of the twenty-four subjects were randomized to isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
531024|NCT00685945|O2|Outcome|L-NMMA + Control|After the intial bradykinin infusion subjects then received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
531025|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
531026|NCT00685945|E1|Reported Event|All Participants|Subjects characteristics for all 24 participants
531027|NCT00685932|B3|Baseline|Total|Total of all reporting groups
531028|NCT00685932|B2|Baseline|Mobius|This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
531029|NCT00685932|B1|Baseline|Control|This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
531030|NCT00685932|P2|Participant Flow|Mobius|Subjects underwent cesarean delivery and the Mobius self-retaining retractor was used as the primary method of retraction during hysterotomy, delivery of infant, hysterotomy repair as well as inspection and irrigation. Other conventional retraction was used for the remainder of the procedure as needed. Decision to abandon use of the Mobius was at the discretion of the primary surgeon.
531031|NCT00685932|P1|Participant Flow|Control|Conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
531032|NCT00685932|O2|Outcome|Mobius|This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
531033|NCT00685932|O1|Outcome|Control|This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
531034|NCT00685932|O2|Outcome|Mobius|This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
531035|NCT00685932|O1|Outcome|Control|This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
531036|NCT00685932|E2|Reported Event|Mobius|This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
531037|NCT00685932|E1|Reported Event|Control|This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
531038|NCT00685880|B3|Baseline|Total|Total of all reporting groups
531039|NCT00685880|B2|Baseline|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
531040|NCT00685880|B1|Baseline|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
531041|NCT00685880|P2|Participant Flow|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
531042|NCT00685880|P1|Participant Flow|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
531043|NCT00685880|O2|Outcome|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
531044|NCT00685880|O1|Outcome|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
531045|NCT00685880|E2|Reported Event|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
531046|NCT00685880|E1|Reported Event|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
531047|NCT00685802|B1|Baseline|Cilostazol 50 mg Tablets and Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either Cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
531048|NCT00685802|P2|Participant Flow|Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours.
531049|NCT00685802|P1|Participant Flow|Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours.
531050|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531559|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531051|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531052|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531053|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531054|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531055|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531056|NCT00685802|E2|Reported Event|Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
531057|NCT00685802|E1|Reported Event|Cilostazol 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
531058|NCT00685763|B1|Baseline|Proton Radiation and Chemotherapy|Unresectable Carcinoma of the Pancreas
531059|NCT00685763|P1|Participant Flow|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
531060|NCT00685763|O1|Outcome|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
531061|NCT00685763|E1|Reported Event|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
531062|NCT00685698|B1|Baseline|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531063|NCT00685698|P1|Participant Flow|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531064|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531065|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531066|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531067|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531068|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531069|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531070|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531071|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531072|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531073|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
534948|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531074|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531075|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531076|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531077|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531078|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531079|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531080|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531081|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531082|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531083|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531084|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531085|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531086|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531087|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531088|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531089|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531090|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531091|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531092|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531093|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531094|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531095|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531096|NCT00685698|E1|Reported Event|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
531097|NCT00685685|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
531098|NCT00685685|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mevacor® 40 mg after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours.
531099|NCT00685685|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours.
531100|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531101|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531102|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531103|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
534949|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531104|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531105|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531106|NCT00685685|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
531107|NCT00685685|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
531108|NCT00685659|B4|Baseline|Total|Total of all reporting groups
531109|NCT00685659|B3|Baseline|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531110|NCT00685659|B2|Baseline|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531111|NCT00685659|B1|Baseline|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531112|NCT00685659|P3|Participant Flow|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531113|NCT00685659|P2|Participant Flow|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531114|NCT00685659|P1|Participant Flow|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531115|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531116|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531117|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531118|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531119|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531120|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531121|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531122|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531123|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531124|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531125|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531126|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531127|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531128|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531129|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531130|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531131|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531132|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531133|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531134|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531135|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531136|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531137|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531138|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531139|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531140|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531141|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531142|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531143|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531144|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531145|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531146|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531147|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531148|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531221|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
531149|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531150|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531151|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531152|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531153|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531154|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531155|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531156|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531157|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531158|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531159|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531160|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531161|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531162|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531163|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531164|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531165|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531166|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531167|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531168|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531169|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531170|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531171|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
534950|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531172|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531173|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531174|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531175|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531176|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531177|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531178|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531179|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531180|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531181|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531182|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531183|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531184|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531185|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531186|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531187|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531188|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531189|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531190|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531191|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531192|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531193|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531222|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
534951|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531194|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531195|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531196|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531197|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531198|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531199|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531200|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531201|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531202|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531203|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531204|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531205|NCT00685659|E3|Reported Event|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
531206|NCT00685659|E2|Reported Event|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
531207|NCT00685659|E1|Reported Event|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
531208|NCT00685516|B4|Baseline|Total|Total of all reporting groups
531209|NCT00685516|B3|Baseline|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
531210|NCT00685516|B2|Baseline|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
531211|NCT00685516|B1|Baseline|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
531212|NCT00685516|P3|Participant Flow|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
531213|NCT00685516|P2|Participant Flow|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
531214|NCT00685516|P1|Participant Flow|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
531215|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
531216|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
531217|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
531218|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
531219|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
531220|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
531319|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
531223|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
531224|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
531225|NCT00685516|O2|Outcome|Arm II - Water|Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
531226|NCT00685516|O1|Outcome|Arm I - Green Tea|Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
531227|NCT00685516|E3|Reported Event|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
531228|NCT00685516|E2|Reported Event|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
531229|NCT00685516|E1|Reported Event|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
531230|NCT00685477|B1|Baseline|All Study Participants|CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments.
531231|NCT00685477|P6|Participant Flow|Experimental Sequence CBA|Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes
531232|NCT00685477|P5|Participant Flow|Experimental Sequence CAB|Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes
531233|NCT00685477|P4|Participant Flow|Experimental Sequence BCA|Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes
531234|NCT00685477|P3|Participant Flow|Experimental Sequence BAC|Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes
531235|NCT00685477|P2|Participant Flow|Experimental Sequence ACB|Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes
531236|NCT00685477|P1|Participant Flow|Experimental Sequence ABC|Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes
531237|NCT00685477|O3|Outcome|60 Minute Infusion|Drug given over 60 minutes
531238|NCT00685477|O2|Outcome|30 Minute Infusion|Drug given over 30 minutes
531239|NCT00685477|O1|Outcome|15 Minute Infusion|Drug given over 15 minutes
531240|NCT00685477|O3|Outcome|60 Min Infusion|Drug given over 60 minutes infusion
531241|NCT00685477|O2|Outcome|30 Min Infusion|Drug given over 30 minutes infusion
531242|NCT00685477|O1|Outcome|15min Infusion|Drug given over 15 minutes infusion
531243|NCT00685477|E1|Reported Event|All Study Participants|Drug given over 15 minute infusion to look at lowest coefficient of variation in infusion, followed by infusion over 30 minutes, followed by infusion over 60 minutes
531244|NCT00685399|B8|Baseline|Total|Total of all reporting groups
531245|NCT00685399|B7|Baseline|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
531246|NCT00685399|B6|Baseline|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
531247|NCT00685399|B5|Baseline|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
531248|NCT00685399|B4|Baseline|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
531249|NCT00685399|B3|Baseline|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
531250|NCT00685399|B2|Baseline|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
531251|NCT00685399|B1|Baseline|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
531252|NCT00685399|P8|Participant Flow|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
531253|NCT00685399|P7|Participant Flow|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
531254|NCT00685399|P6|Participant Flow|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg subcutaneously (s.c.) and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
531255|NCT00685399|P5|Participant Flow|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
531256|NCT00685399|P4|Participant Flow|Cohort 4|Participants who experienced a remission of their uveitis within 8 weeks after receiving their final dose of AIN457 while enrolled in Cohorts 1, 2, 3, 5 or 6 were administered with AIN457 10 mg/kg, i.v. infusion (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
531257|NCT00685399|P3|Participant Flow|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
531258|NCT00685399|P2|Participant Flow|Cohort 2|Participants were administered with AIN457 (Sp2/0 or Chinese hamster ovary cell (CHO) derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed a second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
531259|NCT00685399|P1|Participant Flow|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 milligrams per kilogram (mg/kg) intravenous (i.v.) dose on Day 1 and Day 22.
531320|NCT00685295|E2|Reported Event|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
531260|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
531261|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
531262|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
531263|NCT00685399|O1|Outcome|Complete Study|All participants who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and have non-missing values at both Day 1 and Day 57 for at least one of the outcomes that define participants who respond.
531264|NCT00685399|O5|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
531265|NCT00685399|O4|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
531266|NCT00685399|O3|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
531267|NCT00685399|O2|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
531268|NCT00685399|O1|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
531269|NCT00685399|O6|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
531270|NCT00685399|O5|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
531271|NCT00685399|O4|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
531272|NCT00685399|O3|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
531273|NCT00685399|O2|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
531274|NCT00685399|O1|Outcome|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
531275|NCT00685399|O8|Outcome|Cohort 6 Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
531276|NCT00685399|O7|Outcome|Cohort 6 Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
531277|NCT00685399|O6|Outcome|Cohort 6 Arm 1|Participants were administered with AIN457 300 mg s.c. and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
531278|NCT00685399|O5|Outcome|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
531279|NCT00685399|O4|Outcome|Cohort 4|Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
531280|NCT00685399|O3|Outcome|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
531281|NCT00685399|O2|Outcome|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22. 3 participants from cohort 1 rolled on into this cohort.
531282|NCT00685399|O1|Outcome|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
531283|NCT00685399|E8|Reported Event|Cohort 4 (Extension)|Participants were administered with AIN457 10 mg/kg, i.v. (with or without a short course of corticosteroids) once a flare had occurred, or periodically at a frequency of not more than once per month at the discretion of the investigator.
531284|NCT00685399|E7|Reported Event|Cohort 6 - Arm 3|Participants were administered with AIN457 30 mg/kg i.v. and s.c. saline injections every 4 weeks (Days 1 and 29) and saline i.v. infusions and saline s.c. injections on Days 15 and 43 to maintain masking of treatment groups.
531285|NCT00685399|E6|Reported Event|Cohort 6 - Arm 2|Participants were administered with AIN457 10 mg/kg i.v. and s.c. saline injections every two weeks (Days 1, 15, 29, and 43).
531286|NCT00685399|E5|Reported Event|Cohort 6 - Arm 1|Participants were administered with AIN457 300 mg s.c.and saline i.v. infusion every two weeks (Days 1, 15, 29, and 43).
531287|NCT00685399|E4|Reported Event|Cohort 5|Participants were administered with AIN457 30 mg/kg single i.v. dose. A second dose was given when all 4 participants completed at least 29 days, and the 30 mg/kg dose was well tolerated by all.
531288|NCT00685399|E3|Reported Event|Cohort 3|Participants were administered with AIN457 10 mg/kg i.v. dose on Day 1 and Day 22.
531289|NCT00685399|E2|Reported Event|Cohort 2|Participants were administered with AIN457 (Sp2/0 or CHO derived) 10 mg/kg, (CHO-derived) 3 mg/kg or (CHO derived) 1 mg/kg i.v. dose on Day 1 and if needed second dose of AIN457 10 mg/kg i.v. dose either on Day 15 or Day 22.
531290|NCT00685399|E1|Reported Event|Cohort 1|Participants were administered with AIN457 (Sp2/0-derived) 10 mg/kg i.v. dose on Day 1 and Day 22.
531321|NCT00685295|E1|Reported Event|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
531322|NCT00685178|B5|Baseline|Total|Total of all reporting groups
531291|NCT00685373|B1|Baseline|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
531292|NCT00685373|P1|Participant Flow|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
531293|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
531294|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
531295|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
531296|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
531297|NCT00685373|E1|Reported Event|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
531298|NCT00685334|B3|Baseline|Total|Total of all reporting groups
531299|NCT00685334|B2|Baseline|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
531300|NCT00685334|B1|Baseline|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
531301|NCT00685334|P2|Participant Flow|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
531302|NCT00685334|P1|Participant Flow|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
531303|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
531304|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
531305|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
531306|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
531307|NCT00685334|E2|Reported Event|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
531308|NCT00685334|E1|Reported Event|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
531309|NCT00685295|B3|Baseline|Total|Total of all reporting groups
531310|NCT00685295|B2|Baseline|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
531311|NCT00685295|B1|Baseline|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
531312|NCT00685295|P2|Participant Flow|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
531313|NCT00685295|P1|Participant Flow|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
531314|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|"Active Comparator Group:~Subject receives:~Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill~Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet~Lansoprazole: lansoprazole 15mg rapidly dissolving tablet~Oxycodone: Oxycodone 5/325 mg tablet"
531315|NCT00685295|O1|Outcome|Arm 1 / Fentora|"Intervention Group:~Subject receives:~placebo oral/swallowed pill~Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet~Fentanyl: Fentanyl rapid dissolving tablet 100mcg"
531316|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
531317|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
531318|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
531323|NCT00685178|B4|Baseline|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531324|NCT00685178|B3|Baseline|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
531325|NCT00685178|B2|Baseline|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial"
531326|NCT00685178|B1|Baseline|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531327|NCT00685178|P4|Participant Flow|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
531328|NCT00685178|P3|Participant Flow|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531329|NCT00685178|P2|Participant Flow|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial"
531330|NCT00685178|P1|Participant Flow|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531331|NCT00685178|O4|Outcome|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
531332|NCT00685178|O3|Outcome|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531333|NCT00685178|O2|Outcome|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial"
531334|NCT00685178|O1|Outcome|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531335|NCT00685178|O4|Outcome|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
531336|NCT00685178|O3|Outcome|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531337|NCT00685178|O2|Outcome|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial"
531338|NCT00685178|O1|Outcome|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.~capsules are administered from week 4 through 25 of the trial~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531339|NCT00685178|E4|Reported Event|4 Placebo + NonCR|placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
531340|NCT00685178|E3|Reported Event|3 Placebo + CR|"Placebo and contingency reinforcement for urine sample confirming cocaine abstinence~Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results"
531341|NCT00685178|E2|Reported Event|2 Topiramate + NonCR|"Topiramate and random reinforcement irrespective of cocaine use~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day."
531342|NCT00685178|E1|Reported Event|1 Topiramate + CR|"topiramate and contingency reinforcement for urine sample confirming cocaine abstinence~topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day."
534952|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531343|NCT00685165|B1|Baseline|Primidone 50 mg Tablets and Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast of at least 10 hours.
531344|NCT00685165|P2|Participant Flow|Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.
531345|NCT00685165|P1|Participant Flow|Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
531346|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
531347|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
531348|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
531349|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
531350|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
531351|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
531352|NCT00685165|E2|Reported Event|Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
531353|NCT00685165|E1|Reported Event|Primidone 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
531354|NCT00685139|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
531355|NCT00685139|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast.
531356|NCT00685139|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast.
531357|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
531358|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
531359|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
531360|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
531361|NCT00685139|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
531362|NCT00685139|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran 100 mg following an overnight fast.
531363|NCT00685035|B1|Baseline|All Study Participants|"Half patients randomly assigned to HFCWC therapy first with a higher-pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period~VEST Airway Clearance System, Model 205 : Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects"
531364|NCT00685035|P2|Participant Flow|Lower Pressure/Mid-freq, Then Higher Pressure/Variable-freq|HFCWC therapy first with a lower pressure/mid-frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the higher-pressure/variable frequency HFCWC protocol (2nd Intervention).
531560|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
531365|NCT00685035|P1|Participant Flow|Higher Pressure/Variable-freq, Then Lower Pressure/Mid-freq|HFCWC therapy first with a higher pressure/variable frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol (2nd Intervention).
531366|NCT00685035|O4|Outcome|Perceived Effectiveness Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
531367|NCT00685035|O3|Outcome|Perceived Effectiveness Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
531368|NCT00685035|O2|Outcome|Perceived Comfort Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
531369|NCT00685035|O1|Outcome|Perceived Comfort Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
531370|NCT00685035|O8|Outcome|"G Loss Modulus 100 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531371|NCT00685035|O7|Outcome|"G Loss Modulus 100 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531372|NCT00685035|O6|Outcome|"G Loss Modulus 1 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531373|NCT00685035|O5|Outcome|"G Loss Modulus 1 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531374|NCT00685035|O4|Outcome|G' Storage Modulus 100 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531388|NCT00684996|B1|Baseline|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
531389|NCT00684996|P1|Participant Flow|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
531375|NCT00685035|O3|Outcome|G' Storage Modulus 100 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531376|NCT00685035|O2|Outcome|G' Storage Modulus at 1 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531377|NCT00685035|O1|Outcome|G' Storage Modulus at 1 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
531378|NCT00685035|O4|Outcome|Change in FVC Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
531379|NCT00685035|O3|Outcome|Change in FVC Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
531380|NCT00685035|O2|Outcome|Change in FEV1 Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
531381|NCT00685035|O1|Outcome|Change in FEV1 Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
531382|NCT00685035|O4|Outcome|Sputum Dry Weight Lower Pressure/Mid-frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
531383|NCT00685035|O3|Outcome|Sputum Dry Weight Higher Pressure/Variable Frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
531384|NCT00685035|O2|Outcome|Sputum Wet Weight Lower Pressure/Mid-frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
531385|NCT00685035|O1|Outcome|Sputum Wet Weight Higher Pressure/Variable Frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
531386|NCT00685035|E2|Reported Event|Higher Pressure/Variable Frequency|
531387|NCT00685035|E1|Reported Event|Lower Pressure/Mid-frequency|
531468|NCT00684775|O1|Outcome|Work Plus Naltrexone Prescription|Participants could work and earn vouchers but did not to take naltrexone to work and earn vouchers.
531390|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity un til the recommended phase II dose (RPTD) of bevacizumab is determined.
531391|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
531392|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
531393|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
531394|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
531395|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
531396|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
531397|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
531398|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
531399|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
531400|NCT00684996|E1|Reported Event|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
531401|NCT00684983|B3|Baseline|Total|Total of all reporting groups
531402|NCT00684983|B2|Baseline|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
531403|NCT00684983|B1|Baseline|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531404|NCT00684983|P2|Participant Flow|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
531405|NCT00684983|P1|Participant Flow|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531406|NCT00684983|O2|Outcome|Arm II (Cixutumumab, Lapatinib Ditosylate, Capecitabine)|"Patients receive capecitabine and lapatinib ditosylate as in Arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Cixutumumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lapatinib Ditosylate: Given PO~Quality-of-Life Assessment: Ancillary studies"
531407|NCT00684983|O1|Outcome|Arm I (Lapatinib Ditosylate, Capecitabine)|"Patients receive capecitabine PO BID on days 1-14 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Laboratory Biomarker Analysis: Correlative studies~Lapatinib Ditosylate: Given PO~Quality-of-Life Assessment: Ancillary studies"
531408|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
531409|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531410|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
531411|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531412|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
531413|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531414|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
534953|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531415|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531416|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
531417|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531418|NCT00684983|E2|Reported Event|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
531419|NCT00684983|E1|Reported Event|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
531420|NCT00684814|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours.
531421|NCT00684814|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
531422|NCT00684814|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
531423|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
531424|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
531425|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
531426|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
531427|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
531428|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
531429|NCT00684814|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
531430|NCT00684814|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
531431|NCT00684788|B3|Baseline|Total|Total of all reporting groups
531432|NCT00684788|B2|Baseline|Work Plus Naltrexone Contingency|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months."
531433|NCT00684788|B1|Baseline|Work Plus Naltrexone Prescription|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531434|NCT00684788|P2|Participant Flow|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months."
531435|NCT00684788|P1|Participant Flow|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531436|NCT00684788|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months."
531513|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531514|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531437|NCT00684788|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531438|NCT00684788|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months."
531439|NCT00684788|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531440|NCT00684788|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months."
531441|NCT00684788|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531442|NCT00684788|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections for 6 months."
531443|NCT00684788|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531444|NCT00684788|O2|Outcome|Work Plus Naltrexone Contingency|"Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections."
531445|NCT00684788|O1|Outcome|Work Plus Naltrexone Prescription|"Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone, but access to working and earning salary will not be contingent on doing so."
531446|NCT00684788|O2|Outcome|Work Plus Naltrexone Contingency|Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
531447|NCT00684788|O1|Outcome|Work Plus Naltrexone Prescription|Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
531448|NCT00684788|O2|Outcome|Work Plus Naltrexone Contingency|"Participants will be offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531449|NCT00684788|O1|Outcome|Work Plus Naltrexone Prescription|"An extended-release depot formulation of naltrexone was used. Participants will be offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so."
531450|NCT00684788|E2|Reported Event|Work Plus Naltrexone Contingency|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. "
531451|NCT00684788|E1|Reported Event|Work Plus Naltrexone Prescription|"An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months."
531452|NCT00684775|B3|Baseline|Total|Total of all reporting groups
531453|NCT00684775|B2|Baseline|2 Work Plus Naltrexone Contingency|"Work Plus Naltrexone Contingency~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
534954|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531454|NCT00684775|B1|Baseline|1 Work Plus Naltrexone Prescription|"Work Plus Naltrexone Prescription~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
531455|NCT00684775|P2|Participant Flow|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Work Plus Naltrexone Contingency participants were required to take monthly depot naltrexone injections to work and earn salary."
531456|NCT00684775|P1|Participant Flow|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Prescription condition could work and earn salary independent of whether or not they took depot naltrexone injections."
531457|NCT00684775|O2|Outcome|Work Plus Naltrexone Contingency|"Participants could work and earn vouchers and had to take naltrexone to work and earn vouchers: employment-based reinforcement.~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
531458|NCT00684775|O1|Outcome|Work Plus Naltrexone Prescription|Participants could work and earn vouchers but did not to take naltrexone to work and earn vouchers.
531459|NCT00684775|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who complete the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
531460|NCT00684775|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who complete the oral naltrexone induction (N=38)were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months.Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone monthly, but access to working and earning salary was not contingent on doing so."
531461|NCT00684775|O2|Outcome|Work Plus Naltrexone Contingency|"Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.~Work Plus Naltrexone Contingency: Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
531462|NCT00684775|O1|Outcome|Work Plus Naltrexone Prescription|Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
531463|NCT00684775|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
531464|NCT00684775|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone monthly, but access to working and earning salary was not contingent on doing so."
531465|NCT00684775|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
531466|NCT00684775|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone injections for 6 months. Participants in the Work Plus Naltrexone Prescription condition could work and earn wages independent of whether or not the took scheduled injections."
531467|NCT00684775|O2|Outcome|Work Plus Naltrexone Contingency|"Participants could work and earn vouchers and had to take naltrexone to work and earn vouchers: employment-based reinforcement.~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
531561|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531469|NCT00684775|O2|Outcome|Work Plus Naltrexone Contingency|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month."
531470|NCT00684775|O1|Outcome|Work Plus Naltrexone Prescription|"Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone injections for 6 months. Participants in the Work Plus Naltrexone Prescription condition could work and earn wages independent of whether or not the took scheduled injections."
531471|NCT00684775|E2|Reported Event|2 Work Plus Naltrexone Contingency|"Work Plus Naltrexone Contingency~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
531472|NCT00684775|E1|Reported Event|1 Work Plus Naltrexone Prescription|"Work Plus Naltrexone Prescription~employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so."
531473|NCT00684762|B1|Baseline|Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
531474|NCT00684762|P2|Participant Flow|Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
531475|NCT00684762|P1|Participant Flow|Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
531476|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
531477|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531478|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
531479|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531480|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
531481|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
531482|NCT00684762|E2|Reported Event|Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
531483|NCT00684762|E1|Reported Event|Cilostazol 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
531484|NCT00684749|B1|Baseline|Total Population|All surgical patients
531485|NCT00684749|P1|Participant Flow|Total Population|All surgical patients
531486|NCT00684749|O1|Outcome|Total Population|All surgical patients
531487|NCT00684749|E1|Reported Event|Total Population|All surgical patients
531515|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531562|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
531488|NCT00684723|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531489|NCT00684723|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531490|NCT00684723|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531491|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531492|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531493|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531494|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531495|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531496|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531497|NCT00684723|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high- calorie breakfast.
531498|NCT00684723|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
531499|NCT00684671|B4|Baseline|Total|Total of all reporting groups
531500|NCT00684671|B3|Baseline|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531501|NCT00684671|B2|Baseline|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531502|NCT00684671|B1|Baseline|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531503|NCT00684671|P3|Participant Flow|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531504|NCT00684671|P2|Participant Flow|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531505|NCT00684671|P1|Participant Flow|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531506|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531507|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531508|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531509|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531510|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531511|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531512|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531516|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531517|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531518|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531519|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531520|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531521|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531522|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531523|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531524|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531525|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531526|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531527|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531528|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531529|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531530|NCT00684671|E3|Reported Event|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
531531|NCT00684671|E2|Reported Event|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
531532|NCT00684671|E1|Reported Event|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
531533|NCT00684645|B1|Baseline|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531534|NCT00684645|P1|Participant Flow|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531535|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531536|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531537|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531538|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531539|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531540|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531541|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531542|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531543|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531544|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531545|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531546|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531547|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531548|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531549|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531550|NCT00684645|E1|Reported Event|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
531551|NCT00684593|B3|Baseline|Total|Total of all reporting groups
531552|NCT00684593|B2|Baseline|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
531553|NCT00684593|B1|Baseline|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531554|NCT00684593|P2|Participant Flow|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
531555|NCT00684593|P1|Participant Flow|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531556|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531557|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531563|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531564|NCT00684593|E2|Reported Event|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
531565|NCT00684593|E1|Reported Event|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
531566|NCT00684567|B1|Baseline|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
531567|NCT00684567|P1|Participant Flow|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
531568|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
531569|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
531570|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
531571|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
531572|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
531573|NCT00684567|E1|Reported Event|Radiotherapy/Temozolomide|
531574|NCT00684554|B3|Baseline|Total|Total of all reporting groups
531575|NCT00684554|B2|Baseline|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
531576|NCT00684554|B1|Baseline|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
531577|NCT00684554|P2|Participant Flow|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
531578|NCT00684554|P1|Participant Flow|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
531579|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
531580|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
531581|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
531582|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
531583|NCT00684554|E2|Reported Event|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
531584|NCT00684554|E1|Reported Event|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
531585|NCT00684541|B3|Baseline|Total|Total of all reporting groups
531586|NCT00684541|B2|Baseline|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
531587|NCT00684541|B1|Baseline|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
531588|NCT00684541|P2|Participant Flow|Interpretation Control Condition (ICC)|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
531589|NCT00684541|P1|Participant Flow|Interpretation Modification Program (IMP)|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except that participants received feedback about their responses. Specifically, participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials. Participants received negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials (76 social and 34 nonsocial) in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Thus, participants were assessed with different materials than those seen during the IMP. Each IMP session lasted approximately 20 min.
531618|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531619|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531620|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531621|NCT00684515|E3|Reported Event|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531622|NCT00684515|E2|Reported Event|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531590|NCT00684541|O2|Outcome|Interpretation Control Condition|"The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.~Interpretation Control Condition: Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation."
531591|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
531592|NCT00684541|O2|Outcome|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
531593|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
531594|NCT00684541|E2|Reported Event|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
531595|NCT00684541|E1|Reported Event|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
531596|NCT00684515|B4|Baseline|Total|Total of all reporting groups
531597|NCT00684515|B3|Baseline|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531598|NCT00684515|B2|Baseline|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531599|NCT00684515|B1|Baseline|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531600|NCT00684515|P3|Participant Flow|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531601|NCT00684515|P2|Participant Flow|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531602|NCT00684515|P1|Participant Flow|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531603|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531604|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531605|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531606|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531607|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531608|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531609|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531610|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531611|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531612|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531613|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531614|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531615|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
531616|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
531617|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531661|NCT00684307|B1|Baseline|150 mg od|AZD0837 150 mg od
531623|NCT00684515|E1|Reported Event|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
531624|NCT00684424|B1|Baseline|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531625|NCT00684424|P1|Participant Flow|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531626|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531627|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531628|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531629|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531630|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531631|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531632|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531633|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531634|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531635|NCT00684424|O1|Outcome|Pregabalin|
531636|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531637|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531638|NCT00684424|E1|Reported Event|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
531639|NCT00684411|B1|Baseline|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
531640|NCT00684411|P1|Participant Flow|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
531641|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
531642|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
531643|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
531644|NCT00684411|E1|Reported Event|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
531645|NCT00684320|B3|Baseline|Total|Total of all reporting groups
531646|NCT00684320|B2|Baseline|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
531662|NCT00684307|P5|Participant Flow|VKA INR 2-3|
531663|NCT00684307|P4|Participant Flow|200 mg bd|AZD0837 200 mg bd
531664|NCT00684307|P3|Participant Flow|450 mg od|AZD0837 450 mg od
531647|NCT00684320|B1|Baseline|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
531648|NCT00684320|P2|Participant Flow|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
531649|NCT00684320|P1|Participant Flow|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
531650|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
531651|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
531652|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
531653|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
531654|NCT00684320|E2|Reported Event|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
531655|NCT00684320|E1|Reported Event|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
531656|NCT00684307|B6|Baseline|Total|Total of all reporting groups
531657|NCT00684307|B5|Baseline|VKA INR 2-3|
531658|NCT00684307|B4|Baseline|200 mg bd|AZD0837 200 mg bd
531659|NCT00684307|B3|Baseline|450 mg od|AZD0837 450 mg od
531660|NCT00684307|B2|Baseline|300 mg od|AZD0837 300 mg od
531732|NCT00684255|B1|Baseline|Systemic Sclerosis (SSc)|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
531733|NCT00684255|P1|Participant Flow|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
531734|NCT00684255|O2|Outcome|Systemic Sclerosis (SSc)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Systemic Sclerosis (SSc)
531735|NCT00684255|O1|Outcome|Medically Refractory Systemic Lupus Erythematosus (SLE)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Medically Refractory Systemic Lupus Erythematosus (SLE)
531736|NCT00684255|E1|Reported Event|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
531737|NCT00684242|B1|Baseline|Lenalidomide|10 mg by mouth daily
531738|NCT00684242|P1|Participant Flow|Lenalidomide|10 mg by mouth daily
531739|NCT00684242|O1|Outcome|Lenalidomide|10 mg by mouth daily
531740|NCT00684242|E1|Reported Event|Lenalidomide|10 mg by mouth daily
531741|NCT00684203|B7|Baseline|Total|Total of all reporting groups
531742|NCT00684203|B6|Baseline|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531743|NCT00684203|B5|Baseline|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531744|NCT00684203|B4|Baseline|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
531745|NCT00684203|B3|Baseline|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531746|NCT00684203|B2|Baseline|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531747|NCT00684203|B1|Baseline|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531748|NCT00684203|P6|Participant Flow|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531749|NCT00684203|P5|Participant Flow|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531750|NCT00684203|P4|Participant Flow|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
531751|NCT00684203|P3|Participant Flow|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531752|NCT00684203|P2|Participant Flow|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531753|NCT00684203|P1|Participant Flow|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531754|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531755|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531756|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531757|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531758|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531759|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531760|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531761|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531762|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531763|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531764|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
534955|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
531765|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531766|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531767|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531768|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531769|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531770|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531771|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531772|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531773|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531774|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531775|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531776|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531777|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531778|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531779|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531780|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531781|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531782|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531783|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531784|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531785|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531786|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531787|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531788|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531789|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531790|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531791|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531792|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531793|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531840|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
531794|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531795|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531796|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531797|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531798|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531799|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531800|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531801|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531802|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531803|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531804|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531805|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531806|NCT00684203|E5|Reported Event|Placebo/Placebo|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531807|NCT00684203|E4|Reported Event|Vorapaxar 40 mg/2.5 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531808|NCT00684203|E3|Reported Event|Vorapaxar 40 mg/1 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531809|NCT00684203|E2|Reported Event|Vorapaxar 20 mg/2.5 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531810|NCT00684203|E1|Reported Event|Vorapaxar 20 mg/1 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
531811|NCT00684177|B3|Baseline|Total|Total of all reporting groups
531812|NCT00684177|B2|Baseline|Placebo|Matching placebo
531813|NCT00684177|B1|Baseline|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531814|NCT00684177|P2|Participant Flow|Placebo|Matching placebo
531815|NCT00684177|P1|Participant Flow|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531816|NCT00684177|O2|Outcome|Placebo|Matching placebo
531817|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531818|NCT00684177|O2|Outcome|Placebo|Matching placebo
531819|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531820|NCT00684177|O2|Outcome|Placebo|Matching placebo
531821|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531822|NCT00684177|O2|Outcome|Placebo|Matching placebo
531823|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531824|NCT00684177|O2|Outcome|Placebo|Matching placebo
531825|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531826|NCT00684177|O2|Outcome|Placebo|Matching placebo
531827|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531828|NCT00684177|E2|Reported Event|Placebo|Matching placebo
531829|NCT00684177|E1|Reported Event|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
531830|NCT00684138|B3|Baseline|Total|Total of all reporting groups
531831|NCT00684138|B2|Baseline|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
531832|NCT00684138|B1|Baseline|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
531833|NCT00684138|P2|Participant Flow|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
531834|NCT00684138|P1|Participant Flow|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
531835|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
531836|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
531837|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
531838|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
531839|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
531841|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
531842|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
531843|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
531844|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
531845|NCT00684138|E4|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
531846|NCT00684138|E3|Reported Event|ACRYSOF® ReSTOR® +3.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only
531847|NCT00684138|E2|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only
531848|NCT00684138|E1|Reported Event|ACRYSOF® ReSTOR® +3.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only
531849|NCT00684073|B1|Baseline|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531850|NCT00684073|P1|Participant Flow|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531851|NCT00684073|O5|Outcome|Day 5 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531852|NCT00684073|O4|Outcome|Day 4 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531853|NCT00684073|O3|Outcome|Day 3 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531854|NCT00684073|O2|Outcome|Day 2 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531855|NCT00684073|O1|Outcome|Day 1 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531856|NCT00684073|E1|Reported Event|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
531857|NCT00684060|B3|Baseline|Total|Total of all reporting groups
531858|NCT00684060|B2|Baseline|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531859|NCT00684060|B1|Baseline|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531860|NCT00684060|P2|Participant Flow|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531861|NCT00684060|P1|Participant Flow|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531862|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531863|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531864|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531865|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531866|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531867|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531868|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531869|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531870|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531871|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531872|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531873|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531874|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531875|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531876|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531877|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531878|NCT00684060|E2|Reported Event|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
531879|NCT00684060|E1|Reported Event|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
531880|NCT00684047|B4|Baseline|Total|Total of all reporting groups
531881|NCT00684047|B3|Baseline|Manual Compression Primary Part (II)|Subjects treated with manual compression were analyzed.
531882|NCT00684047|B2|Baseline|FS Grifols Primary Part (II)|Subjects treated during FS Grifols Primary Part (II) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
531883|NCT00684047|B1|Baseline|FS Grifols Preliminary Part (I)|Subjects treated during FS Grifols Preliminary Part (I) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
531884|NCT00684047|P3|Participant Flow|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
531885|NCT00684047|P2|Participant Flow|FS Grifols Primary Part (II)|FS Grifol was applied in subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
532082|NCT00683826|E2|Reported Event|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
531886|NCT00684047|P1|Participant Flow|FS Grifols Preliminary Part (I)|FS Grifols was applied in all subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
531887|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
531888|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
531889|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
531890|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifol was applied in subjects. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
531891|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
531892|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
531893|NCT00684047|E2|Reported Event|Manual Compression Primary Part (II)|The safety population included all subjects treated with manual compression in the Manual Compression Primary Part (II). Five subjects randomized to this arm were treated with FS Grifols and thus were removed from this arm for the safety analyses.
531894|NCT00684047|E1|Reported Event|FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]|"The safety population included all subjects treated with FS Grifols in Preliminary Part (I) and Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols): Preliminary Part (I): 72 subjects and Primary Part (II): 110 subjects.~The safety population included five additional subjects treated with FS Grifols instead of manual compression who were not included in the baseline and efficacy outcome analyses."
531895|NCT00684021|B5|Baseline|Total|Total of all reporting groups
531896|NCT00684021|B4|Baseline|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531897|NCT00684021|B3|Baseline|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531898|NCT00684021|B2|Baseline|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531899|NCT00684021|B1|Baseline|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531900|NCT00684021|P4|Participant Flow|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531901|NCT00684021|P3|Participant Flow|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531902|NCT00684021|P2|Participant Flow|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531903|NCT00684021|P1|Participant Flow|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531904|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531905|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531906|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531907|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531908|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531909|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531910|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531911|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531912|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531913|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531914|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531915|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531916|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531917|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531918|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531919|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531920|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531921|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531922|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531923|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531924|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531925|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531926|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531927|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531928|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531929|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531930|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531931|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531932|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531933|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531934|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531935|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531936|NCT00684021|E4|Reported Event|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
531937|NCT00684021|E3|Reported Event|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
531938|NCT00684021|E2|Reported Event|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
531939|NCT00684021|E1|Reported Event|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
531940|NCT00683930|B4|Baseline|Total|Total of all reporting groups
531941|NCT00683930|B3|Baseline|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
531942|NCT00683930|B2|Baseline|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
531943|NCT00683930|B1|Baseline|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
531944|NCT00683930|P3|Participant Flow|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
531945|NCT00683930|P2|Participant Flow|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
531946|NCT00683930|P1|Participant Flow|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
531947|NCT00683930|O4|Outcome|Mycophenolate Mofetil 3 g/Day|MMF 500 mg tablets; 6 tablets twice daily for 52 weeks
531948|NCT00683930|O3|Outcome|Mycophenolate Mofetil 2 g/Day|MMF 500 mg tablets; 4 tablets twice daily for 52 weeks
531949|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
531950|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
531951|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
531952|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
531953|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
531954|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
531955|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
531956|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
531957|NCT00683930|E3|Reported Event|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
531958|NCT00683930|E2|Reported Event|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
531959|NCT00683930|E1|Reported Event|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
531960|NCT00683917|B4|Baseline|Total|Total of all reporting groups
531961|NCT00683917|B3|Baseline|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
531962|NCT00683917|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
531963|NCT00683917|B1|Baseline|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
531964|NCT00683917|P1|Participant Flow|Proellex All Groups|Proellex 25 mg: Proellex 50 mg, placebo, 1 capsule daily for 4 months Study prematurely terminated, no further data available
531965|NCT00683917|O3|Outcome|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
531966|NCT00683917|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
531967|NCT00683917|O1|Outcome|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
531968|NCT00683917|E3|Reported Event|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
531969|NCT00683917|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
531970|NCT00683917|E1|Reported Event|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
531971|NCT00683904|B3|Baseline|Total|Total of all reporting groups
531972|NCT00683904|B2|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531973|NCT00683904|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531974|NCT00683904|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL. infused over 30 minutes on Day 1 of each 21-day cycle.
532173|NCT00683774|B3|Baseline|Total|Total of all reporting groups
531975|NCT00683904|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531976|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531977|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531978|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531979|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531980|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531981|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531982|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531983|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531984|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531985|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531986|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531987|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531988|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
531989|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
531990|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
531991|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
531992|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
531993|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
531994|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531995|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531996|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531997|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531998|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
531999|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
532000|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
532001|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
532002|NCT00683904|O1|Outcome|All Treated|All subjects who received at least 1 dose of either ixabepilone or carboplatin
532003|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
532004|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
532005|NCT00683904|E2|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
532006|NCT00683904|E1|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
532007|NCT00683878|B4|Baseline|Total|Total of all reporting groups
532008|NCT00683878|B3|Baseline|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532009|NCT00683878|B2|Baseline|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532010|NCT00683878|B1|Baseline|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532011|NCT00683878|P3|Participant Flow|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532012|NCT00683878|P2|Participant Flow|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532013|NCT00683878|P1|Participant Flow|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532014|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532015|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532016|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532017|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532018|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532019|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532020|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532021|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532022|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532023|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532024|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532025|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532026|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532027|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532028|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532029|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532030|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532031|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532032|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532033|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532034|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532035|NCT00683878|E3|Reported Event|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532036|NCT00683878|E2|Reported Event|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532037|NCT00683878|E1|Reported Event|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
532038|NCT00683852|B3|Baseline|Total|Total of all reporting groups
532080|NCT00683826|O1|Outcome|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
532081|NCT00683826|E3|Reported Event|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
534956|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
532039|NCT00683852|B2|Baseline|ADAPT Placebo Group (Placebo/Placebo & Placebo/Drug Groups)|This data was analyzed for the study by comparing placebo vs. drug. Therefore the two groups (placebo/placebo and placebo/drug) that started with placebo during the first phase of the study are combined as one group. Patients in the placebo/placebo sequence received a placebo treatment during the first phase of the study, and a placebo treatment in the second phase. Patients in the placebo/drug sequence received a placebo treatment during the first phase of the study and they received the aripiprazole drug at a dose of 2 mg/day in the second phase of the study.
532040|NCT00683852|B1|Baseline|ADAPT Drug/Drug Group|patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
532041|NCT00683852|P3|Participant Flow|ADAPT Placebo/Drug Group|Patients will be randomly assigned to placebo during the first phase of the study. In the second phase of the study, they will receive the aripiprazole drug at a dose of 2 mg/day.
532042|NCT00683852|P2|Participant Flow|ADAPT Placebo/Placebo Group|Patients randomly assigned to the placebo/placebo sequence: the patients will receive a placebo treatment during the first phase of the study, and a placebo treatment in the second phase.
532043|NCT00683852|P1|Participant Flow|ADAPT Drug/Drug Group|Patients randomly assigned to the drug/drug sequence: the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
532044|NCT00683852|O2|Outcome|ADAPT Placebo/Placebo Group|Patients in the placebo/placebo sequence received a placebo treatment during the first phase of the study, and a placebo treatment in the second phase.
532045|NCT00683852|O1|Outcome|ADAPT Drug/Drug Group|patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase
532046|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
532047|NCT00683852|O1|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
532048|NCT00683852|O2|Outcome|ADAPT Placebo Group|Placebo patient-phases from Placebo/Placebo and Placebo/Drug groups.
532049|NCT00683852|O1|Outcome|ADAPT Drug Group|Aripiprazole patient-phases from the Drug/Drug and Placebo/Drug Groups
532050|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
532051|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
532052|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
532053|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
532054|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
532055|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
532056|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
532057|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
532058|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
532059|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
532060|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
532061|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
532062|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
532063|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
532064|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
532065|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
532066|NCT00683852|O4|Outcome|Phase 1 Placebo Non-Responders on Placebo in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received a placebo treatment in Phase 2
532067|NCT00683852|O3|Outcome|Phase I Placebo|Patients who received Placebo in Phase 1
532068|NCT00683852|O2|Outcome|Phase 1 Placebo Non-Responders on Drug in Phase 2|Patients who received (and had no response) to a Placebo in Phase 1 and then received drug (aripiprazole 2mg/day) in Phase 2
532069|NCT00683852|O1|Outcome|Phase 1 Drug|Patients who received drug in phase 1 (aripiprazole 2 mg/day)
532070|NCT00683852|E3|Reported Event|Placebo/Drug Group|Patients on placebo in Phase 1 who are on drug in phase 2 (Aripiprazole 2 mg/day)
532071|NCT00683852|E2|Reported Event|Placebo/Placebo Group|Patients on placebo in phases 1 and 2
532072|NCT00683852|E1|Reported Event|Drug/Drug Group|Aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase for drug/drug group.
532073|NCT00683826|B4|Baseline|Total|Total of all reporting groups
532074|NCT00683826|B3|Baseline|Leucine 0 Grams-control|Initial intervention.
532075|NCT00683826|B2|Baseline|Leucine 8 Grams|Initial intervention.
532076|NCT00683826|B1|Baseline|Leucine 4 Grams|Initial intervention.
532077|NCT00683826|P1|Participant Flow|All Study Participants|This will be a three-way crossover design, where subjects will be randomized into three groups. All subjects will receive all interventions (0g leucine, 4g leucine, 8g leucine) in a randomized order.
532078|NCT00683826|O3|Outcome|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
532079|NCT00683826|O2|Outcome|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
534957|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
532083|NCT00683826|E1|Reported Event|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
532084|NCT00683800|B3|Baseline|Total|Total of all reporting groups
532085|NCT00683800|B2|Baseline|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532086|NCT00683800|B1|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532087|NCT00683800|P2|Participant Flow|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532088|NCT00683800|P1|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532089|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532090|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532091|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532092|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532093|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532094|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532095|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532096|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532097|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532098|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532099|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532100|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532101|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532102|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532103|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532104|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532105|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532106|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532107|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532108|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532109|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532110|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532111|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532112|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532113|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532114|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532115|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532116|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532117|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532118|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532119|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532120|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532121|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532122|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532123|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532124|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532125|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532126|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532127|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532128|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532129|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532130|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532131|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532174|NCT00683774|B2|Baseline|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532132|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532133|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532134|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532135|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532136|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532137|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532138|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532139|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532140|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532141|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532142|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532143|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532144|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532145|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532146|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532147|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532148|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532149|NCT00683800|E2|Reported Event|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
532150|NCT00683800|E1|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
532151|NCT00683787|B4|Baseline|Total|Total of all reporting groups
532152|NCT00683787|B3|Baseline|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532153|NCT00683787|B2|Baseline|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532154|NCT00683787|B1|Baseline|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
532155|NCT00683787|P3|Participant Flow|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532156|NCT00683787|P2|Participant Flow|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532157|NCT00683787|P1|Participant Flow|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
532158|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532159|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532160|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
532161|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532162|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532163|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
532164|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532165|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532166|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
532167|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532168|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532169|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
532170|NCT00683787|E3|Reported Event|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532171|NCT00683787|E2|Reported Event|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
532172|NCT00683787|E1|Reported Event|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
532175|NCT00683774|B1|Baseline|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532176|NCT00683774|P2|Participant Flow|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532177|NCT00683774|P1|Participant Flow|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532178|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532179|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532180|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532181|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532182|NCT00683774|E2|Reported Event|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532183|NCT00683774|E1|Reported Event|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
532184|NCT00683696|B3|Baseline|Total|Total of all reporting groups
532185|NCT00683696|B2|Baseline|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532186|NCT00683696|B1|Baseline|CRT=ON|Cardiac Resynchronization Therapy activated.
532187|NCT00683696|P2|Participant Flow|CRT=OFF|"Cardiac Resynchronization Therapy deactivated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=OFF."
532188|NCT00683696|P1|Participant Flow|CRT=ON|"Cardiac Resynchronization Therapy activated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=ON."
532189|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532190|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
532191|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532192|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
532193|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532194|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
532195|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532196|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
532197|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532198|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
532199|NCT00683696|O1|Outcome|Subjects That Underwent an Implant Attempt|
532200|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532201|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
532202|NCT00683696|E2|Reported Event|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
532203|NCT00683696|E1|Reported Event|CRT=ON|Cardiac Resynchronization Therapy activated.
532204|NCT00683657|B3|Baseline|Total|Total of all reporting groups
532205|NCT00683657|B2|Baseline|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
532206|NCT00683657|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
532207|NCT00683657|P2|Participant Flow|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
532208|NCT00683657|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
532209|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
532210|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
532211|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
532212|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
532213|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
532214|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
532215|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
532216|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
532217|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
532218|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
532219|NCT00683657|E2|Reported Event|SAXA 5MG + MET|
532220|NCT00683657|E1|Reported Event|PLACEBO + MET|
532221|NCT00683644|B3|Baseline|Total|Total of all reporting groups
532222|NCT00683644|B2|Baseline|Group 2 Placebo First|Placebo capsules administered once a day for 4 months. Washout period of 30 days. Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months.
532223|NCT00683644|B1|Baseline|Group 1 Zinc First|Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months. Washout period of 30 days. Placebo capsules administered once a day for 4 months.
532224|NCT00683644|P2|Participant Flow|Group 2 Placebo First|"Placebo capsules taken once a day for 4 months~PLACEBO 4 MONTHS WASHOUT 1 MONTH ZINC 4 MONTHS"
532225|NCT00683644|P1|Participant Flow|Group 1 Zinc First|Zinc sulfate (50 mg elemental zinc) taken once daily for 4 months ZINC 4 MONTHS WASHOUT 1 MONTH PLACEBO 4 MONTHS
532226|NCT00683644|O2|Outcome|Placebo|Placebo taken once daily. Period of use: 4 months, either on baseline or month 5 (after a washout period of 1 month)
532227|NCT00683644|O1|Outcome|Zinc|Zinc sulfate: Zinc sulfate capsules corresponding to 50 mg of elemental zinc, taken once daily. Period of use: 4 months, either on baseline or month 5 (after a washout period: 1 month)
532228|NCT00683644|O2|Outcome|Placebo|Participants who completed 4 months taking placebo capsules daily, either from baseline to month 4, or after washout period of 1 month (from month 5 to 9).
532229|NCT00683644|O1|Outcome|Zinc|Participants who completed 4 months taking Zinc (50 mg) daily, either from baseline to month 4, or after washout period, from month 5 to 9).
532230|NCT00683644|O2|Outcome|Placebo|Participants that completed 4 months taking placebo capsules daily, either from baseline to month 4 or after a washout period of 1 month (from month 5 to month 9).
532231|NCT00683644|O1|Outcome|Zinc|Participants that completed 4 months taking Zinc (50 mg) daily, either from baseline to month 4, or after washout period, from month 5 to 9).
532232|NCT00683644|E2|Reported Event|Placebo|55 participants received Placebo first and 46 participants received Placebo after 1 month washout. The total number of participants at risk to Placebo is 101.
532233|NCT00683644|E1|Reported Event|Zinc|54 participants received Zinc first and 45 participants received Zinc after 1 month washout. The total number of participants at risk to Zinc is 99.
532234|NCT00683618|B4|Baseline|Total|Total of all reporting groups
532235|NCT00683618|B3|Baseline|Atorvastatin 10mg|Taken orally once daily
532236|NCT00683618|B2|Baseline|Rosuvastatin 10mg|Taken orally once daily
532237|NCT00683618|B1|Baseline|Rosuvastatin 5mg|Taken orally once daily
532238|NCT00683618|P3|Participant Flow|Atorvastatin 10mg|Taken orally once daily
532239|NCT00683618|P2|Participant Flow|Rosuvastatin 10mg|Taken orally once daily
532240|NCT00683618|P1|Participant Flow|Rosuvastatin 5mg|Taken orally once daily
532241|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532242|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532243|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532244|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532245|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532246|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532247|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532248|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532249|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532250|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532251|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532252|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532253|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532254|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532255|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532256|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532257|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532258|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532259|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532260|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532261|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532262|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532263|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532264|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532265|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532266|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532267|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532268|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532269|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532270|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532271|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532272|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532273|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532274|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532275|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532276|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532277|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
532278|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
532279|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532280|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
532281|NCT00683618|O1|Outcome|Rosuvastatin 10mg|Taken orally once daily
532282|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
532283|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
532284|NCT00683618|E3|Reported Event|Atorvastatin 10mg|Taken orally once daily
532285|NCT00683618|E2|Reported Event|Rosuvastatin 10mg|Taken orally once daily
532286|NCT00683618|E1|Reported Event|Rosuvastatin 5mg|Taken orally once daily
532287|NCT00683592|B3|Baseline|Total|Total of all reporting groups
532288|NCT00683592|B2|Baseline|Placebo (ITT Population)|placebo to match vilazodone
532289|NCT00683592|B1|Baseline|Vilazodone (ITT Population)|Vilazodone, 40 mg
532290|NCT00683592|P2|Participant Flow|Placebo|Placebo to match vilazodone. Two tablets per day.
532291|NCT00683592|P1|Participant Flow|Vilazodone|Vilazodone titrated to 40mg. Two tablets per day.
532292|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
532293|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
532294|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
532295|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
532296|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
532297|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
532298|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
532299|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
532300|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
532301|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
532302|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
532303|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
532304|NCT00683592|E2|Reported Event|Placebo (Safety Population)|placebo to match vilazodone
532305|NCT00683592|E1|Reported Event|Vilazodone (Safety Population)|Vilazodone, 40mg
532306|NCT00683475|B3|Baseline|Total|Total of all reporting groups
532307|NCT00683475|B2|Baseline|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532308|NCT00683475|B1|Baseline|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532309|NCT00683475|P2|Participant Flow|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532310|NCT00683475|P1|Participant Flow|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532311|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532312|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532313|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532314|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532315|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532316|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532317|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532318|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532319|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532320|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532321|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532322|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532323|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532439|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532440|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532324|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532325|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532326|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532327|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532328|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532329|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532330|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532331|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532332|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532333|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532334|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532335|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532336|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532337|NCT00683475|E2|Reported Event|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532338|NCT00683475|E1|Reported Event|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
532339|NCT00683449|B6|Baseline|Total|Total of all reporting groups
532340|NCT00683449|B5|Baseline|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
532341|NCT00683449|B4|Baseline|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
532342|NCT00683449|B3|Baseline|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
532396|NCT00683163|P2|Participant Flow|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
532441|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532442|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532343|NCT00683449|B2|Baseline|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
532344|NCT00683449|B1|Baseline|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
532345|NCT00683449|P5|Participant Flow|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
532346|NCT00683449|P4|Participant Flow|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
532347|NCT00683449|P3|Participant Flow|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
532348|NCT00683449|P2|Participant Flow|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
532349|NCT00683449|P1|Participant Flow|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
532350|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
532351|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
532352|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
532353|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
532397|NCT00683163|P1|Participant Flow|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily parathyroid hormone (PTH) 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
532354|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
532355|NCT00683449|O5|Outcome|1,995 MN-221 Administered i.v. for 15 Minutes and 25 Minutes|One subject that was randomized to receive 450 MN-221 intravenously for 15 minutes was administered 1995 micrograms. Another subject that was randomized to receive 450 micrograms for 15 minutes actually received a dose of 1995 micrograms MN-221 intravenously for 25 minutes.
532356|NCT00683449|O4|Outcome|1,000-1,080 μg MN-221 Given i.v. for 15 Minutes|The Data Safety Monitoring Board recommended that subjects can receive MN-221 at 16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose 1000-1080 μg).
532357|NCT00683449|O3|Outcome|450 μg MN-221 Given i.v.|The Data Safety Monitoring Board convened and recommended that the next highest scheduled can be administered to subjects. They received MN-221 at 30 μg/minute for 15 minutes (total dose 450 μg).
532358|NCT00683449|O2|Outcome|Placebo Administered Intravenously|Initial dose group received MN-221 placebo intravenously for 15 minutes. For a subsequent dose group that was scheduled for a longer intravenous infusion of the study drug, subjects received MN-221 placebo intravenously for 15 minutes followed by MN-221 intravenously for 105 minutes.
532359|NCT00683449|O1|Outcome|MN-221 at 16.0 μg/Min for 15 Min (Total 240 μg)|The dosing scheme that consisted of a 15-minute infusion was based on PK (pharmacokinetic) modeling performed using data from the previous MN-221 studies that enrolled either healthy volunteers or subjects with stable mild to moderate asthma.
532360|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
532361|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
532362|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
532363|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
532364|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
532365|NCT00683449|E5|Reported Event|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
532366|NCT00683449|E4|Reported Event|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
532367|NCT00683449|E3|Reported Event|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
532398|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
532399|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
532443|NCT00683020|E2|Reported Event|WAIT LIST Control|WAIT LIST Control: six month Wait List.
534958|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
532368|NCT00683449|E2|Reported Event|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
532369|NCT00683449|E1|Reported Event|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
532370|NCT00683410|B1|Baseline|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
532371|NCT00683410|P1|Participant Flow|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
532372|NCT00683410|O1|Outcome|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
532373|NCT00683410|E1|Reported Event|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
532374|NCT00683384|B1|Baseline|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
532375|NCT00683384|P1|Participant Flow|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
532376|NCT00683384|O1|Outcome|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
532377|NCT00683384|E1|Reported Event|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
532378|NCT00683332|B1|Baseline|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
532379|NCT00683332|P1|Participant Flow|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
532380|NCT00683332|O1|Outcome|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
532381|NCT00683332|E1|Reported Event|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
532382|NCT00683293|B3|Baseline|Total|Total of all reporting groups
532383|NCT00683293|B2|Baseline|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
532384|NCT00683293|B1|Baseline|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
532385|NCT00683293|P2|Participant Flow|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
532386|NCT00683293|P1|Participant Flow|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
532387|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
532388|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
532389|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
532390|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
532391|NCT00683293|E2|Reported Event|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
532392|NCT00683293|E1|Reported Event|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
532393|NCT00683163|B3|Baseline|Total|Total of all reporting groups
532394|NCT00683163|B2|Baseline|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
532395|NCT00683163|B1|Baseline|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
535067|NCT00676403|O1|Outcome|Placebo|
532400|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
532401|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
532402|NCT00683163|E2|Reported Event|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
532403|NCT00683163|E1|Reported Event|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
532404|NCT00683085|B1|Baseline|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
532405|NCT00683085|P1|Participant Flow|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
532406|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
532407|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
532408|NCT00683085|E1|Reported Event|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
532409|NCT00683046|B1|Baseline|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
532410|NCT00683046|P1|Participant Flow|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
532411|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
532412|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
532413|NCT00683046|E1|Reported Event|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
532414|NCT00683020|B3|Baseline|Total|Total of all reporting groups
532415|NCT00683020|B2|Baseline|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532416|NCT00683020|B1|Baseline|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532417|NCT00683020|P2|Participant Flow|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532418|NCT00683020|P1|Participant Flow|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532419|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532420|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532421|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532422|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532423|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532424|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532425|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532426|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532427|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532428|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532429|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532430|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532431|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532432|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532433|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532434|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532435|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532436|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532437|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
532438|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532444|NCT00683020|E1|Reported Event|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
532445|NCT00682929|B4|Baseline|Total|Total of all reporting groups
532446|NCT00682929|B3|Baseline|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532447|NCT00682929|B2|Baseline|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532448|NCT00682929|B1|Baseline|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532449|NCT00682929|P3|Participant Flow|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532450|NCT00682929|P2|Participant Flow|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532451|NCT00682929|P1|Participant Flow|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532452|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532453|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532454|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532455|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532456|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532457|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532458|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532459|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532460|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532461|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532462|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
533340|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
532463|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532464|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532465|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532466|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532467|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532468|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532469|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532470|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532471|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532472|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532473|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532474|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532475|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532476|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532477|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532478|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532479|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532661|NCT00682786|B2|Baseline|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532480|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532481|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532482|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532483|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532484|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532485|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532486|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532487|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532488|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532489|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532490|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532491|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532492|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532493|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532494|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532495|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532496|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532662|NCT00682786|B1|Baseline|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532497|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532498|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532499|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532500|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532501|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532502|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532503|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532504|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532505|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532506|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532507|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532508|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532509|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532510|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532511|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532512|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532513|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532663|NCT00682786|P2|Participant Flow|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532514|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532515|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532516|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532517|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532518|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532519|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532520|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532521|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532522|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532523|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532524|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532525|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532526|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532527|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532528|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532529|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532530|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532664|NCT00682786|P1|Participant Flow|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532531|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532532|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532533|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532534|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532535|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532536|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532537|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532538|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532539|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532540|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532541|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532542|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532543|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532544|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532545|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532546|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532547|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532665|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532548|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532549|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532550|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532551|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532552|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532553|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532554|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532555|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532556|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532557|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532558|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532559|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532560|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532561|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532562|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532563|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532564|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532666|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532565|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532566|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532567|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532568|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532569|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532570|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532571|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532572|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532573|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532574|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532575|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532576|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532577|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532578|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532579|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532580|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532581|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532667|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
535426|NCT00675766|B5|Baseline|Total|Total of all reporting groups
532582|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532583|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532584|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532585|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532586|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532587|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532588|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532589|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532590|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532591|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532592|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532593|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532594|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532595|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532596|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532597|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532598|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532668|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532599|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532600|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532601|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532602|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532603|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532604|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532605|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532606|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532607|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532608|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532609|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532610|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532611|NCT00682929|O3|Outcome|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532612|NCT00682929|O2|Outcome|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532613|NCT00682929|O1|Outcome|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532614|NCT00682929|E3|Reported Event|3) Placebo|"Inhaled placebo is compared to oral placebo.~Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily."
532615|NCT00682929|E2|Reported Event|2) Oral THC|"Inhaled placebo is compared to oral THC.~Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily."
532669|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532616|NCT00682929|E1|Reported Event|1) Inhaled Cannabis|"Inhaled cannabis is compared to oral placebo.~Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily."
532617|NCT00682890|B3|Baseline|Total|Total of all reporting groups
532618|NCT00682890|B2|Baseline|Metformin|metformin 2000 mg and birth control pill daily
532619|NCT00682890|B1|Baseline|Placebo|Placebo tablet and birth control pill daily
532620|NCT00682890|P2|Participant Flow|Metformin|metformin 2000 mg and birth control pill daily
532621|NCT00682890|P1|Participant Flow|Placebo|Placebo tablet and birth control pill daily
532622|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
532623|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
532624|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
532625|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
532626|NCT00682890|E2|Reported Event|Metformin|metformin 2000 mg and birth control pill daily
532627|NCT00682890|E1|Reported Event|Placebo|Placebo tablet and birth control pill daily
532628|NCT00682851|B3|Baseline|Total|Total of all reporting groups
532629|NCT00682851|B2|Baseline|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
532630|NCT00682851|B1|Baseline|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
532631|NCT00682851|P2|Participant Flow|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
532632|NCT00682851|P1|Participant Flow|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
532633|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
532634|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
532635|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
532636|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
532637|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
532638|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
532639|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
532640|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
532641|NCT00682851|E2|Reported Event|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
532642|NCT00682851|E1|Reported Event|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
532643|NCT00682838|B5|Baseline|Total|Total of all reporting groups
532644|NCT00682838|B4|Baseline|Usual Care|Usual care- control group
532645|NCT00682838|B3|Baseline|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
532646|NCT00682838|B2|Baseline|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
532647|NCT00682838|B1|Baseline|Self-management|"Active Intervention~Self-management: Self-management"
532648|NCT00682838|P4|Participant Flow|Usual Care|Usual care- control group
532649|NCT00682838|P3|Participant Flow|SM + TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care~Combination of both SM + TC intervention"
532650|NCT00682838|P2|Participant Flow|Telemonitored Care (TC)|"Active Comparator~Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol"
532651|NCT00682838|P1|Participant Flow|Self-Management (SM)|"Active Intervention~Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective"
532652|NCT00682838|O4|Outcome|Usual Care|Usual care- control group
532653|NCT00682838|O3|Outcome|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
532654|NCT00682838|O2|Outcome|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
532655|NCT00682838|O1|Outcome|Self-management|"Active Intervention~Self-management: Self-management"
532656|NCT00682838|E4|Reported Event|Usual Care|Control Group
532657|NCT00682838|E3|Reported Event|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
532658|NCT00682838|E2|Reported Event|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
532659|NCT00682838|E1|Reported Event|Self-management|"Active Intervention~Self-management: Self-management"
532660|NCT00682786|B3|Baseline|Total|Total of all reporting groups
532670|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532671|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532672|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532673|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532674|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532675|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532676|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532677|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532678|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532679|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532680|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532681|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532682|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532683|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532684|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532685|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532686|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532687|NCT00682786|O2|Outcome|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532688|NCT00682786|O1|Outcome|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532689|NCT00682786|O2|Outcome|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532690|NCT00682786|O1|Outcome|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532691|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532692|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532693|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532694|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532765|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532695|NCT00682786|E2|Reported Event|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532696|NCT00682786|E1|Reported Event|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
532697|NCT00682734|B4|Baseline|Total|Total of all reporting groups
532698|NCT00682734|B3|Baseline|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
532699|NCT00682734|B2|Baseline|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
532700|NCT00682734|B1|Baseline|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
532701|NCT00682734|P3|Participant Flow|Metoclopramide 40 mg Intravenous|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
532702|NCT00682734|P2|Participant Flow|Metoclopramide 20 mg Intravenous|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
532703|NCT00682734|P1|Participant Flow|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous
532704|NCT00682734|O3|Outcome|Metoclopramide 40 mg|Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
532705|NCT00682734|O2|Outcome|Metoclopramide 20 mg|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
532706|NCT00682734|O1|Outcome|Metoclopramide 10 mg Intravenous|Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous
532707|NCT00682734|E3|Reported Event|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
532708|NCT00682734|E2|Reported Event|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
532709|NCT00682734|E1|Reported Event|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
532710|NCT00682643|B3|Baseline|Total|Total of all reporting groups
532711|NCT00682643|B2|Baseline|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532712|NCT00682643|B1|Baseline|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532713|NCT00682643|P2|Participant Flow|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532714|NCT00682643|P1|Participant Flow|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532715|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532716|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532717|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532718|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532719|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532720|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532721|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532722|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532723|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532724|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532725|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532726|NCT00682643|O1|Outcome|Placebo|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
532727|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532728|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
535430|NCT00675766|B1|Baseline|Group 1|HIV-positive adults 50 and older
532729|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532730|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532731|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532732|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532733|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532734|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532735|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532736|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532737|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532738|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532739|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532740|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532741|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532742|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532743|NCT00682643|E2|Reported Event|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
532744|NCT00682643|E1|Reported Event|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
532745|NCT00682565|B4|Baseline|Total|Total of all reporting groups
532746|NCT00682565|B3|Baseline|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532747|NCT00682565|B2|Baseline|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532748|NCT00682565|B1|Baseline|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532749|NCT00682565|P3|Participant Flow|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532750|NCT00682565|P2|Participant Flow|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532751|NCT00682565|P1|Participant Flow|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532752|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532753|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532754|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532755|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532756|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532757|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532758|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532759|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532760|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532761|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532762|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532763|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532764|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
535771|NCT00674700|O3|Outcome|Placebo|Placebo tablet
532766|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532767|NCT00682565|E4|Reported Event|Total|All Patients
532768|NCT00682565|E3|Reported Event|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532769|NCT00682565|E2|Reported Event|Cohort 2 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532770|NCT00682565|E1|Reported Event|Cohort 1 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
532771|NCT00682539|B4|Baseline|Total|Total of all reporting groups
532772|NCT00682539|B3|Baseline|Lucentis|After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
532773|NCT00682539|B2|Baseline|Triamciolone|Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.
532774|NCT00682539|B1|Baseline|Avastin|After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
532775|NCT00682539|P3|Participant Flow|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.
532776|NCT00682539|P2|Participant Flow|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
532777|NCT00682539|P1|Participant Flow|Avastin|15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.
532778|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
532779|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
532780|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
532781|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
532782|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
532783|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
532784|NCT00682539|E3|Reported Event|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.
532785|NCT00682539|E2|Reported Event|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
532786|NCT00682539|E1|Reported Event|Avastin|Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.
532787|NCT00682461|B3|Baseline|Total|Total of all reporting groups
532788|NCT00682461|B2|Baseline|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
532789|NCT00682461|B1|Baseline|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
532790|NCT00682461|P2|Participant Flow|Nicotine Lozenge (2.0 mg)|Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
532791|NCT00682461|P1|Participant Flow|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
532792|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
532793|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
532794|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
532795|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
532796|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
532797|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
532798|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
532799|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
532800|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
532801|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day
532802|NCT00682461|E2|Reported Event|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
536090|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
532803|NCT00682461|E1|Reported Event|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
532804|NCT00682357|B4|Baseline|Total|Total of all reporting groups
532805|NCT00682357|B3|Baseline|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
532806|NCT00682357|B2|Baseline|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
532807|NCT00682357|B1|Baseline|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
532808|NCT00682357|P3|Participant Flow|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
532809|NCT00682357|P2|Participant Flow|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
532810|NCT00682357|P1|Participant Flow|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
532811|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
532812|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
532813|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
532814|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
532815|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
532816|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
532817|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
532818|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
532819|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
532820|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
532821|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
532822|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
532823|NCT00682357|E3|Reported Event|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
532824|NCT00682357|E2|Reported Event|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
532825|NCT00682357|E1|Reported Event|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
532826|NCT00681889|B1|Baseline|Treatment Arm|"10 Patients will receive treatment (Ranibizumab)~Ranibizumab : 10 Patients will receive treatment (Ranibizumab)"
532827|NCT00681889|P1|Participant Flow|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
532828|NCT00681889|O1|Outcome|Treatment Arm|"9 Patients will receive treatment (Ranibizumab)~Ranibizumab : 9 Patients will receive treatment (Ranibizumab)"
532829|NCT00681889|E1|Reported Event|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
532830|NCT00681863|B1|Baseline|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532831|NCT00681863|P1|Participant Flow|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532832|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532833|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532834|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532835|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532836|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532837|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532838|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532839|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532840|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532841|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532842|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532843|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532844|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532845|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532846|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532847|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532848|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532849|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532850|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532851|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532852|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532853|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532854|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532855|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532856|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532857|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532858|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532859|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532860|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532861|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532923|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
533341|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
532862|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532863|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532864|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532865|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532866|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532867|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532868|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532869|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532870|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532871|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532872|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532873|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532874|NCT00681863|E1|Reported Event|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
532875|NCT00681824|B4|Baseline|Total|Total of all reporting groups
532876|NCT00681824|B3|Baseline|FS VH S/D 500 S-apr (Non Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
532877|NCT00681824|B2|Baseline|FS VH S/D 500 S-apr (Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group only includes the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
532878|NCT00681824|B1|Baseline|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532879|NCT00681824|P3|Participant Flow|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.
532880|NCT00681824|P2|Participant Flow|Run-in Participants: FS VH S/D 500 S-apr|One initial
532881|NCT00681824|P1|Participant Flow|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532882|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
532883|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532884|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
532885|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
536206|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
532886|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
532887|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532888|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
532889|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532890|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
532891|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532892|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
532893|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532894|NCT00681824|E2|Reported Event|FS VH S/D 500 S-apr|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
532895|NCT00681824|E1|Reported Event|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
532896|NCT00681811|B3|Baseline|Total|Total of all reporting groups
532897|NCT00681811|B2|Baseline|200 U/kg|Participants received 200 U/kg of HGT1111 IV infusion every other week.
532898|NCT00681811|B1|Baseline|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
532899|NCT00681811|P2|Participant Flow|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
532900|NCT00681811|P1|Participant Flow|100 U/kg HGT-1111|Participants received 100 units per kilogram (U/kg) of HGT1111 intravenous (IV) infusion every other week.
532901|NCT00681811|O2|Outcome|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
532902|NCT00681811|O1|Outcome|100 U/kg HGT-1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
532903|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
532904|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
532905|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
532906|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
532907|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
532908|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
532909|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
532910|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
532911|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
532912|NCT00681811|O5|Outcome|100 U/kg- HGT-1111(Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
532913|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
532914|NCT00681811|O3|Outcome|100 U/kg- HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
532915|NCT00681811|O2|Outcome|200 U/Kg-HGT-1111(Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
532916|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
532917|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
532918|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
532919|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
532920|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
532921|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
532922|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
533465|NCT00680121|P1|Participant Flow|Control Group|Placebo; identically matched to Benfotiamine capsules
532924|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
532925|NCT00681811|E2|Reported Event|200 U/kg HGT1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
532926|NCT00681811|E1|Reported Event|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
532927|NCT00681668|B1|Baseline|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
532928|NCT00681668|P1|Participant Flow|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
532929|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
532930|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
532931|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
532932|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
532933|NCT00681668|E1|Reported Event|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
532934|NCT00681629|B3|Baseline|Total|Total of all reporting groups
532935|NCT00681629|B2|Baseline|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532936|NCT00681629|B1|Baseline|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532937|NCT00681629|P2|Participant Flow|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532938|NCT00681629|P1|Participant Flow|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532939|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532940|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532941|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532942|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532943|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532944|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532945|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532946|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532947|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532948|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532949|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532950|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532951|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532952|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532953|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532954|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532955|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532956|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532957|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532958|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532959|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532960|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532961|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532962|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
533342|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
532963|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532964|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532965|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532966|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532967|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532968|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532969|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532970|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532971|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532972|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532973|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532974|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532975|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532976|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532977|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
533024|NCT00681538|B2|Baseline|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533117|NCT00681187|E3|Reported Event|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
532978|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532979|NCT00681629|E2|Reported Event|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
532980|NCT00681629|E1|Reported Event|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
532981|NCT00681590|B3|Baseline|Total|Total of all reporting groups
532982|NCT00681590|B2|Baseline|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
532983|NCT00681590|B1|Baseline|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
532984|NCT00681590|P2|Participant Flow|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
532985|NCT00681590|P1|Participant Flow|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
532986|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
532987|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
532988|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
532989|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
532990|NCT00681590|E2|Reported Event|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
532991|NCT00681590|E1|Reported Event|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
532992|NCT00681564|B3|Baseline|Total|Total of all reporting groups
532993|NCT00681564|B2|Baseline|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
532994|NCT00681564|B1|Baseline|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
532995|NCT00681564|P2|Participant Flow|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
532996|NCT00681564|P1|Participant Flow|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
532997|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
532998|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
532999|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533000|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533001|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533002|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533003|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533194|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533004|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533005|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533006|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533007|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533008|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533009|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533010|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533011|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533012|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533013|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533014|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533015|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533016|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533017|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533018|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533019|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533020|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533021|NCT00681564|E2|Reported Event|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
533022|NCT00681564|E1|Reported Event|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
533023|NCT00681538|B3|Baseline|Total|Total of all reporting groups
533025|NCT00681538|B1|Baseline|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533026|NCT00681538|P2|Participant Flow|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533027|NCT00681538|P1|Participant Flow|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533028|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533029|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533030|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533031|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533032|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533033|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533034|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533035|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533036|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533037|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533038|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533039|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533040|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533041|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533042|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533043|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533044|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533045|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533046|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533047|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533048|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533049|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533050|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533051|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533052|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533053|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533054|NCT00681538|E2|Reported Event|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
533055|NCT00681538|E1|Reported Event|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
533056|NCT00681473|B1|Baseline|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
533057|NCT00681473|P1|Participant Flow|Proton Radiation Therapy|Proton Radiation Therapy daily (Monday through Friday) for six weeks. This is a single arm study.
533058|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
533059|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
533060|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
533061|NCT00681473|E1|Reported Event|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
533062|NCT00681291|B3|Baseline|Total|Total of all reporting groups
533063|NCT00681291|B2|Baseline|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
533064|NCT00681291|B1|Baseline|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
533065|NCT00681291|P2|Participant Flow|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
533066|NCT00681291|P1|Participant Flow|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
533067|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
533068|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
533069|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
533070|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
533071|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
533072|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
533073|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
533074|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
533075|NCT00681291|E2|Reported Event|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
533076|NCT00681291|E1|Reported Event|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
533077|NCT00681265|B1|Baseline|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
533078|NCT00681265|P1|Participant Flow|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
533079|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
533080|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
533081|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
533082|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
533083|NCT00681265|E2|Reported Event|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
533084|NCT00681265|E1|Reported Event|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
533085|NCT00681187|B3|Baseline|Total|Total of all reporting groups
533086|NCT00681187|B2|Baseline|Group 2 HCP Then Self or Partner Administration|Administration by HCP then self or partner administration.
533087|NCT00681187|B1|Baseline|Group 1 Self or Partner First Then HCP Administration|Self or partner administration followed by HCP administration.
533088|NCT00681187|P2|Participant Flow|Group 2 HCP Then Self or Partner Administration|Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject’s home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection.
533089|NCT00681187|P1|Participant Flow|Group 1 Self or Partner First Then HCP Administration|Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject’s home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day.
533090|NCT00681187|O1|Outcome|Overall Study Group|One HCP from each site who enrolled participants answered the questions
533091|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533092|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533093|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
533094|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
533095|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533096|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533097|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
533098|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
533099|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533100|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
533101|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
533102|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533103|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
533104|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
533105|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533106|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training) included three unsupervised injections every 28th day at the subject's home.
533107|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533108|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training period) included three unsupervised injections every 28th day at the subject's home.
533109|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533110|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
533111|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
533112|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
533113|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
533114|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
533115|NCT00681187|O2|Outcome|Group 2 HCP Then Self or Partner Administration|Administration by HCP then Self or Partner Administration.
533116|NCT00681187|O1|Outcome|Group 1 Self or Partner First Then HCP Administration|Self or Partner Administration followed by HCP Administration.
533118|NCT00681187|E2|Reported Event|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
533119|NCT00681187|E1|Reported Event|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
533120|NCT00681109|B4|Baseline|Total|Total of all reporting groups
533121|NCT00681109|B3|Baseline|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
533122|NCT00681109|B2|Baseline|Placebo|Artificial Tear Topical Ophthalmic Solution
533123|NCT00681109|B1|Baseline|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
533124|NCT00681109|P3|Participant Flow|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
533125|NCT00681109|P2|Participant Flow|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
533126|NCT00681109|P1|Participant Flow|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
533127|NCT00681109|O3|Outcome|Anakinra 5% Topical Ophthalmic Solution|The OSDI was assessed for patients taking Anakinra (KINERET) 5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
533128|NCT00681109|O2|Outcome|Artificial Tear Topical Ophthalmic Solution|The OSDI was assessed for patients taking placebo. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
533129|NCT00681109|O1|Outcome|Anakinra 2.5% Topical Ophthalmic Solution|In this study, the OSDI was assessed for patients taking Anakinra (KINERET) 2.5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
533130|NCT00681109|O3|Outcome|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
533131|NCT00681109|O2|Outcome|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
533132|NCT00681109|O1|Outcome|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
533133|NCT00681109|O3|Outcome|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
533134|NCT00681109|O2|Outcome|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
533135|NCT00681109|O1|Outcome|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
533136|NCT00681109|O3|Outcome|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
533137|NCT00681109|O2|Outcome|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
533138|NCT00681109|O1|Outcome|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
533139|NCT00681109|E3|Reported Event|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
533140|NCT00681109|E2|Reported Event|Placebo|Artificial Tear Topical Ophthalmic Solution
533141|NCT00681109|E1|Reported Event|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
533142|NCT00681044|B1|Baseline|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533143|NCT00681044|P1|Participant Flow|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection (SCC) Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533144|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533145|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533146|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533147|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533148|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533149|NCT00681044|E1|Reported Event|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
533150|NCT00681031|B1|Baseline|All Enrolled|Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
533151|NCT00681031|P1|Participant Flow|All Enrolled|Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
533152|NCT00681031|O1|Outcome|All Enrolled|Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
533153|NCT00681031|E1|Reported Event|V211|All enrolled participants who received vaccination
533154|NCT00680953|B4|Baseline|Total|Total of all reporting groups
533155|NCT00680953|B3|Baseline|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
533156|NCT00680953|B2|Baseline|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533157|NCT00680953|B1|Baseline|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533158|NCT00680953|P3|Participant Flow|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
533159|NCT00680953|P2|Participant Flow|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533160|NCT00680953|P1|Participant Flow|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533161|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
533162|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533163|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533164|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
533165|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533166|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533167|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
533168|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533169|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533170|NCT00680953|E3|Reported Event|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
533171|NCT00680953|E2|Reported Event|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533172|NCT00680953|E1|Reported Event|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
533173|NCT00680914|B3|Baseline|Total|Total of all reporting groups
533174|NCT00680914|B2|Baseline|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533175|NCT00680914|B1|Baseline|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533176|NCT00680914|P2|Participant Flow|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533177|NCT00680914|P1|Participant Flow|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533178|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533179|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533180|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533181|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533182|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533183|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533184|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533185|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533186|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533187|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533188|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533189|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533190|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533191|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533192|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533193|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
536207|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
533195|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533196|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533197|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533198|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533199|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533200|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533201|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533202|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533203|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533204|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533205|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533206|NCT00680914|E2|Reported Event|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533207|NCT00680914|E1|Reported Event|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
533208|NCT00680901|B3|Baseline|Total|Total of all reporting groups
533209|NCT00680901|B2|Baseline|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533210|NCT00680901|B1|Baseline|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533211|NCT00680901|P2|Participant Flow|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533212|NCT00680901|P1|Participant Flow|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533213|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533214|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
534015|NCT00678899|B1|Baseline|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
533215|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533216|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533217|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533218|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533219|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533220|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533221|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533222|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533272|NCT00680823|P1|Participant Flow|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533273|NCT00680823|O3|Outcome|Observation|Observation for 30 minutes.
533274|NCT00680823|O2|Outcome|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533343|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533223|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533224|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533225|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533226|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533227|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533228|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533229|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533230|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533275|NCT00680823|O1|Outcome|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533276|NCT00680823|O3|Outcome|Observation|Observation for 30 minutes.
533277|NCT00680823|O2|Outcome|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533344|NCT00680745|E4|Reported Event|Placebo + Glimepiride|Placebo comparator plus glimepiride
533231|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533232|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533233|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533234|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533235|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533236|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533237|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533238|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533278|NCT00680823|O1|Outcome|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533279|NCT00680823|O3|Outcome|Observation|Observation for 30 minutes.
533280|NCT00680823|O2|Outcome|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533345|NCT00680745|E3|Reported Event|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533239|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533240|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533241|NCT00680901|E2|Reported Event|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
533242|NCT00680901|E1|Reported Event|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
533243|NCT00680862|B1|Baseline|Group 1|VA employees
533244|NCT00680862|P1|Participant Flow|Group 1|VA employees
533245|NCT00680862|O1|Outcome|Group 1|VA employees
533246|NCT00680862|E1|Reported Event|Group 1|VA employees
533247|NCT00680836|B3|Baseline|Total|Total of all reporting groups
533248|NCT00680836|B2|Baseline|Treatment|These patients have Irritable Bowel syndrome (IBS) and are receiving the rifaximin 550mg twice a day
533249|NCT00680836|B1|Baseline|Placebo|These patients have Irritable Bowel syndrome (IBS) and are receiving the placebo twice a day
533250|NCT00680836|P2|Participant Flow|Active Group|These patients have Irritable Bowel syndrome and are receiving rifaximin 550mg twice a day
533251|NCT00680836|P1|Participant Flow|Placebo Group|These patients have Irritable Bowel syndrome and are receiving the placebo twice a day
533252|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
533253|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
533254|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
533255|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
533256|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
533257|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
533258|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
533259|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
533260|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
533261|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
533262|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
533263|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
533264|NCT00680836|E2|Reported Event|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
533265|NCT00680836|E1|Reported Event|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
533266|NCT00680823|B4|Baseline|Total|Total of all reporting groups
533267|NCT00680823|B3|Baseline|Observation|Observation for 30 minutes.
533268|NCT00680823|B2|Baseline|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533269|NCT00680823|B1|Baseline|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533270|NCT00680823|P3|Participant Flow|Observation|Observation for 30 minutes.
533271|NCT00680823|P2|Participant Flow|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533339|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533281|NCT00680823|O1|Outcome|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533282|NCT00680823|E3|Reported Event|Observation|Observation for 30 minutes.
533283|NCT00680823|E2|Reported Event|Normal Saline Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.~Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533284|NCT00680823|E1|Reported Event|Ropivacaine Injections|"Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.~Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1."
533285|NCT00680797|B5|Baseline|Total|Total of all reporting groups
533286|NCT00680797|B4|Baseline|-T -E|-Testosterone, -Estrogen
533287|NCT00680797|B3|Baseline|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
533288|NCT00680797|B2|Baseline|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
533289|NCT00680797|B1|Baseline|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
533290|NCT00680797|P4|Participant Flow|-T -E|-Testosterone, -Estrogen
533291|NCT00680797|P3|Participant Flow|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
533292|NCT00680797|P2|Participant Flow|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
533293|NCT00680797|P1|Participant Flow|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
533294|NCT00680797|O4|Outcome|-T -E|-Testosterone, -Estrogen
533295|NCT00680797|O3|Outcome|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
533296|NCT00680797|O2|Outcome|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
533297|NCT00680797|O1|Outcome|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
533298|NCT00680797|E4|Reported Event|-T -E|-Testosterone, -Estrogen
533299|NCT00680797|E3|Reported Event|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
533300|NCT00680797|E2|Reported Event|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
533301|NCT00680797|E1|Reported Event|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
533302|NCT00680771|B3|Baseline|Total|Total of all reporting groups
533303|NCT00680771|B2|Baseline|Good Sleepers|participants meetoing criteira for Good Sleepers
533304|NCT00680771|B1|Baseline|Primary Insomnia|patients meeting criteria for primary insomnia.
533305|NCT00680771|P2|Participant Flow|Good Sleepers|Subjects meeting criteira for Good Sleepers
533306|NCT00680771|P1|Participant Flow|Primary Insomnia|Subjects meeting criteria for primary insomnia.
533307|NCT00680771|O2|Outcome|Good Sleepers|participants meetoing criteira for Good Sleepers
533308|NCT00680771|O1|Outcome|Primary Insomnia|patients meeting criteria for primary insomnia.
533309|NCT00680771|E2|Reported Event|Good Sleepers|participants meetoing criteira for Good Sleepers
533310|NCT00680771|E1|Reported Event|Primary Insomnia|patients meeting criteria for primary insomnia.
533311|NCT00680745|B5|Baseline|Total|Total of all reporting groups
533312|NCT00680745|B4|Baseline|Placebo + Glimepiride|Placebo comparator plus glimepiride
533313|NCT00680745|B3|Baseline|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533314|NCT00680745|B2|Baseline|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
533315|NCT00680745|B1|Baseline|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533316|NCT00680745|P4|Participant Flow|Placebo + Glimepiride|Placebo comparator plus glimepiride
533317|NCT00680745|P3|Participant Flow|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533318|NCT00680745|P2|Participant Flow|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
533319|NCT00680745|P1|Participant Flow|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533320|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
533321|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533322|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
533323|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533324|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
533325|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533326|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
533327|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533328|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
533329|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533330|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
533331|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533332|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
533333|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533334|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
533335|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533336|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
533337|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
533338|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
536208|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
533346|NCT00680745|E2|Reported Event|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
533347|NCT00680745|E1|Reported Event|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
533348|NCT00680706|B3|Baseline|Total|Total of all reporting groups
533349|NCT00680706|B2|Baseline|Control|Receives placebo
533350|NCT00680706|B1|Baseline|Thiamine|Receives thiamine
533351|NCT00680706|P2|Participant Flow|Control|Receives placebo
533352|NCT00680706|P1|Participant Flow|Thiamine|Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.
533353|NCT00680706|O2|Outcome|Thiamine|
533354|NCT00680706|O1|Outcome|Control|Placebo
533355|NCT00680706|O2|Outcome|Thiamine|
533356|NCT00680706|O1|Outcome|Control|Placebo
533357|NCT00680706|E2|Reported Event|Control|Receives placebo
533358|NCT00680706|E1|Reported Event|Thiamine|Receives thiamine
533359|NCT00680628|B3|Baseline|Total|Total of all reporting groups
533360|NCT00680628|B2|Baseline|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
533361|NCT00680628|B1|Baseline|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
533362|NCT00680628|P2|Participant Flow|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
533363|NCT00680628|P1|Participant Flow|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
533364|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
533365|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
533366|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
533367|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
533368|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
533369|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
533370|NCT00680628|E2|Reported Event|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
533371|NCT00680628|E1|Reported Event|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
533372|NCT00680524|B1|Baseline|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
533373|NCT00680524|P1|Participant Flow|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
533374|NCT00680524|O1|Outcome|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
533375|NCT00680524|E1|Reported Event|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
533376|NCT00680459|B3|Baseline|Total|Total of all reporting groups
533377|NCT00680459|B2|Baseline|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533378|NCT00680459|B1|Baseline|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533379|NCT00680459|P2|Participant Flow|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533380|NCT00680459|P1|Participant Flow|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533381|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533382|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533383|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533384|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533385|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533386|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533387|NCT00680459|E2|Reported Event|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533388|NCT00680459|E1|Reported Event|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
533389|NCT00680407|B4|Baseline|Total|Total of all reporting groups
533390|NCT00680407|B3|Baseline|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
533391|NCT00680407|B2|Baseline|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533392|NCT00680407|B1|Baseline|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533393|NCT00680407|P3|Participant Flow|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
533394|NCT00680407|P2|Participant Flow|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533395|NCT00680407|P1|Participant Flow|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533396|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
533397|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533398|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533399|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
533400|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533401|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533402|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
533403|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533404|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533405|NCT00680407|E3|Reported Event|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
533406|NCT00680407|E2|Reported Event|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533407|NCT00680407|E1|Reported Event|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
533408|NCT00680368|B1|Baseline|Physician Residents and Attending Physicians|includes physician residents and attending physicians who were asked to sit through a face to face interview with a research assistant following a clinical encounter with a patient
533409|NCT00680368|P1|Participant Flow|Group 1|The study began with 112 responders: 75 physician residents and 37 attending physicians. Only 60 of the 75 residents had been supervised by one of the 37 participating attending physicians. Thus, 15 residents were dropped from study. Both resident and their attending physician were surveyed to report total supervision time for each of 148 clinical encounters with 143 patients. There were more clinical encounters than patients because some patients had more than one encounter. There were more physician residents than attending physicians because attending physicians may have supervised more than one resident. There were more clinical encounters than residents because a resident may be involved in more than one clinical encounter with a patient.
533410|NCT00680368|O1|Outcome|Attending Physicians|Results reported only for the 37 attending physicians in the study sample
533411|NCT00680368|O1|Outcome|Physician Residents|Includes physician residents who had a supervising attending physician participating in the study, and who received a face to face interview with a research assistant
533412|NCT00680368|O1|Outcome|Physician Residents and Attending Physicians|Sample included 112, including 60 physician residents and 37 attending physicians
533413|NCT00680368|E1|Reported Event|Group 1|Sample included 75 resident physicians. No adverse events noted.
533414|NCT00680316|B3|Baseline|Total|Total of all reporting groups
533415|NCT00680316|B2|Baseline|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
533416|NCT00680316|B1|Baseline|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
533417|NCT00680316|P2|Participant Flow|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
533418|NCT00680316|P1|Participant Flow|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
533419|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
533420|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
533421|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
533422|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
533423|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
533424|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
533425|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
533426|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
533427|NCT00680316|E2|Reported Event|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
533428|NCT00680316|E1|Reported Event|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
533429|NCT00680225|B1|Baseline|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
533430|NCT00680225|P1|Participant Flow|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
533431|NCT00680225|O1|Outcome|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
533432|NCT00680225|O1|Outcome|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
533433|NCT00680225|E1|Reported Event|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
533434|NCT00680186|B3|Baseline|Total|Total of all reporting groups
533435|NCT00680186|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
533436|NCT00680186|B1|Baseline|Dabigatran 150 mg|bid oral
533437|NCT00680186|P2|Participant Flow|Warfarin|PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0
533438|NCT00680186|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
533439|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533440|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533441|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533442|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533443|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533444|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533445|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533446|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533447|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533448|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533449|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533450|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533451|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533452|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533453|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533454|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533455|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533456|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533457|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
533458|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
533459|NCT00680186|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
533460|NCT00680186|E1|Reported Event|Dabigatran 150 mg|bid oral
533461|NCT00680121|B3|Baseline|Total|Total of all reporting groups
533462|NCT00680121|B2|Baseline|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
533463|NCT00680121|B1|Baseline|Control Group|Placebo; identically matched to Benfotiamine capsules
533464|NCT00680121|P2|Participant Flow|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
533466|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
533467|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
533468|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
533469|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
533470|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
533471|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
533472|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
533473|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
533474|NCT00680121|E2|Reported Event|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
533475|NCT00680121|E1|Reported Event|Control Group|Placebo; identically matched to Benfotiamine capsules
533476|NCT00680056|B3|Baseline|Total|Total of all reporting groups
533477|NCT00680056|B2|Baseline|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
533478|NCT00680056|B1|Baseline|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
533479|NCT00680056|P2|Participant Flow|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
533480|NCT00680056|P1|Participant Flow|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
533481|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
533482|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
533483|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in either first intervention period or second intervention period.
533484|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
533485|NCT00680056|E2|Reported Event|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
533486|NCT00680056|E1|Reported Event|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
533487|NCT00680043|B4|Baseline|Total|Total of all reporting groups
533488|NCT00680043|B3|Baseline|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533489|NCT00680043|B2|Baseline|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533490|NCT00680043|B1|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
533491|NCT00680043|P3|Participant Flow|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533492|NCT00680043|P2|Participant Flow|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533493|NCT00680043|P1|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
533494|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533495|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533496|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
533497|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533498|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533499|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
533500|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533693|NCT00679783|B4|Baseline|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533501|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533502|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
533503|NCT00680043|E3|Reported Event|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533504|NCT00680043|E2|Reported Event|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
533505|NCT00680043|E1|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
533506|NCT00680017|B3|Baseline|Total|Total of all reporting groups
533507|NCT00680017|B2|Baseline|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
533508|NCT00680017|B1|Baseline|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
533509|NCT00680017|P2|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
533510|NCT00680017|P1|Participant Flow|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
533511|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
533512|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
533513|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
533514|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
533515|NCT00680017|E2|Reported Event|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
533516|NCT00680017|E1|Reported Event|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
533517|NCT00679952|B3|Baseline|Total|Total of all reporting groups
533518|NCT00679952|B2|Baseline|Natural Drainage Group|natural drainage group (ND group)
533519|NCT00679952|B1|Baseline|Closed Suction Drainage Group|closed suction drainage group (CD group)
533520|NCT00679952|P2|Participant Flow|Natural Drainage Group|natural drainage group (ND group)
533521|NCT00679952|P1|Participant Flow|Closed Suction Drainage Group|closed suction drainage group (CD group)
533522|NCT00679952|O2|Outcome|Natural Drainage Group|natural drainage group (ND group)
533523|NCT00679952|O1|Outcome|Closed Suction Drainage Group|closed suction drainage group (CD group)
533524|NCT00679952|E2|Reported Event|Natural Drainage Group|natural drainage group (ND group)
533525|NCT00679952|E1|Reported Event|Closed Suction Drainage Group|closed suction drainage group (CD group)
533526|NCT00679939|B3|Baseline|Total|Total of all reporting groups
533527|NCT00679939|B2|Baseline|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533528|NCT00679939|B1|Baseline|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533529|NCT00679939|P2|Participant Flow|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533530|NCT00679939|P1|Participant Flow|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533531|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533532|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533533|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533534|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533535|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533536|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533537|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533538|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533539|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533540|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533541|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533542|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533543|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533544|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533545|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533546|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533547|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533548|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533549|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533550|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533551|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533552|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533553|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533554|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533555|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533556|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533557|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533558|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533559|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533560|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533561|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533562|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533563|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533564|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533565|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533566|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533567|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533568|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533569|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533570|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533571|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533572|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533573|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533574|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533575|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533576|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533577|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533578|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533579|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533580|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533581|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533582|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533583|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533584|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533585|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533586|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533587|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533588|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533589|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533590|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533591|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533592|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533593|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533594|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533595|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533596|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533597|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533598|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533599|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533600|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533601|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533602|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533603|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533604|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533605|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533606|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533607|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533608|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533609|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533610|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533611|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533612|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533613|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533614|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533615|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533616|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533617|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533618|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533619|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533620|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533621|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533622|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533623|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533624|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533625|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533626|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533627|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533628|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533629|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533630|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533631|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533632|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533633|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533634|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533635|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533636|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533637|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533638|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533639|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533640|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533641|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533642|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533643|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533644|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533645|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533646|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533647|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533648|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533649|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533650|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533651|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533652|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533653|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533654|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533655|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533656|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533657|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533658|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533659|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533660|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533661|NCT00679939|O2|Outcome|Metformin|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533662|NCT00679939|O1|Outcome|Rosiglitazone|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533663|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533664|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533665|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533666|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533667|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533668|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533669|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533670|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533671|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533672|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533965|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533673|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533674|NCT00679939|E4|Reported Event|Metformin: MET OL|At Week 52, all participants receiving MET in the DB Period were switched to open-label MET therapy for 24 weeks during the OL Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533675|NCT00679939|E3|Reported Event|Rosiglitazone: MET OL|At Week 52, all participants receiving RSG in the DB Period were switched to open-label Metformin (MET) therapy for 24 weeks during the Open-label (OL) Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
533676|NCT00679939|E2|Reported Event|Metformin: DB|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4 in the 52-week DB Period.
533677|NCT00679939|E1|Reported Event|Rosiglitazone: DB|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4 in the 52-week Double-Blind (DB) Period.
533678|NCT00679913|B3|Baseline|Total|Total of all reporting groups
533679|NCT00679913|B2|Baseline|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
533680|NCT00679913|B1|Baseline|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
533681|NCT00679913|P2|Participant Flow|Extended Pancreatoduodenectomy|extended pancreatoduodenectomy Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.
533682|NCT00679913|P1|Participant Flow|Standard Pancreatoduodenectomy|standard pancreatoduodenectomy Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)
533683|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized"
533684|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
533685|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
533686|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
533687|NCT00679913|E2|Reported Event|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized."
533688|NCT00679913|E1|Reported Event|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
533689|NCT00679783|B8|Baseline|Total|Total of all reporting groups
533690|NCT00679783|B7|Baseline|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533691|NCT00679783|B6|Baseline|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533692|NCT00679783|B5|Baseline|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533694|NCT00679783|B3|Baseline|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533695|NCT00679783|B2|Baseline|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533696|NCT00679783|B1|Baseline|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533697|NCT00679783|P7|Participant Flow|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533698|NCT00679783|P6|Participant Flow|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533699|NCT00679783|P5|Participant Flow|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533700|NCT00679783|P4|Participant Flow|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533701|NCT00679783|P3|Participant Flow|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533702|NCT00679783|P2|Participant Flow|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533703|NCT00679783|P1|Participant Flow|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533704|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533705|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533706|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533707|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533708|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533709|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533710|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533711|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533712|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533713|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533714|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533715|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533716|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533717|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533718|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533719|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533720|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533721|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533722|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533966|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533723|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533724|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533725|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533726|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533727|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533728|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533729|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533730|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533731|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533732|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533733|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533734|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533735|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533736|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533737|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533738|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533739|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533740|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533741|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533742|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533743|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533744|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533745|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533746|NCT00679783|E7|Reported Event|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
533747|NCT00679783|E6|Reported Event|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
533748|NCT00679783|E5|Reported Event|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
533749|NCT00679783|E4|Reported Event|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533750|NCT00679783|E3|Reported Event|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
533751|NCT00679783|E2|Reported Event|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
533967|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533752|NCT00679783|E1|Reported Event|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
533753|NCT00679627|B3|Baseline|Total|Total of all reporting groups
533754|NCT00679627|B2|Baseline|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533755|NCT00679627|B1|Baseline|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533756|NCT00679627|P2|Participant Flow|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533757|NCT00679627|P1|Participant Flow|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533758|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533759|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533760|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533761|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533762|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533763|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533764|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533765|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533766|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533767|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533784|NCT00679432|P3|Participant Flow|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533768|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533769|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533770|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533771|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533772|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533773|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533774|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533775|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533776|NCT00679627|E2|Reported Event|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
533777|NCT00679627|E1|Reported Event|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
533778|NCT00679432|B5|Baseline|Total|Total of all reporting groups
533779|NCT00679432|B4|Baseline|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533780|NCT00679432|B3|Baseline|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533781|NCT00679432|B2|Baseline|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
533782|NCT00679432|B1|Baseline|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533783|NCT00679432|P4|Participant Flow|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533871|NCT00679289|B3|Baseline|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533872|NCT00679289|B2|Baseline|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533785|NCT00679432|P2|Participant Flow|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
533786|NCT00679432|P1|Participant Flow|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533787|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533788|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533789|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
533790|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533791|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533792|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533793|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
533794|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533795|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533796|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533797|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
533798|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533799|NCT00679432|E4|Reported Event|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533800|NCT00679432|E3|Reported Event|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533801|NCT00679432|E2|Reported Event|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
533802|NCT00679432|E1|Reported Event|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
533803|NCT00679380|B5|Baseline|Total|Total of all reporting groups
533804|NCT00679380|B4|Baseline|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
533805|NCT00679380|B3|Baseline|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
533806|NCT00679380|B2|Baseline|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533807|NCT00679380|B1|Baseline|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533808|NCT00679380|P4|Participant Flow|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
533809|NCT00679380|P3|Participant Flow|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
533810|NCT00679380|P2|Participant Flow|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533811|NCT00679380|P1|Participant Flow|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533812|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
533813|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
533814|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533815|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533816|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
533817|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
533818|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533819|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533820|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
533821|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
533822|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533823|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533824|NCT00679380|E4|Reported Event|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
533825|NCT00679380|E3|Reported Event|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
533826|NCT00679380|E2|Reported Event|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533827|NCT00679380|E1|Reported Event|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
533828|NCT00679367|B1|Baseline|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
533829|NCT00679367|P1|Participant Flow|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
533830|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day days 1-21~melphalan: 5 mg/m2 days 1-4"
533831|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
533832|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
533833|NCT00679367|E1|Reported Event|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
533834|NCT00679354|B1|Baseline|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
533964|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533835|NCT00679354|P1|Participant Flow|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
533836|NCT00679354|O1|Outcome|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
533837|NCT00679354|E1|Reported Event|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
533838|NCT00679341|B3|Baseline|Total|Total of all reporting groups
533839|NCT00679341|B2|Baseline|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533840|NCT00679341|B1|Baseline|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533841|NCT00679341|P2|Participant Flow|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533842|NCT00679341|P1|Participant Flow|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533843|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533844|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533845|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533846|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533847|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533848|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533849|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533850|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533851|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533852|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533853|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533854|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533855|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533856|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533857|NCT00679341|E2|Reported Event|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
533858|NCT00679341|E1|Reported Event|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
533859|NCT00679302|B3|Baseline|Total|Total of all reporting groups
533860|NCT00679302|B2|Baseline|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
533861|NCT00679302|B1|Baseline|Placebo Group|Maalox and bitter mixture
533862|NCT00679302|P2|Participant Flow|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
533863|NCT00679302|P1|Participant Flow|Placebo Group|Maalox and bitter mixture
533864|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
533865|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
533866|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
533867|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
533868|NCT00679302|E2|Reported Event|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
533869|NCT00679302|E1|Reported Event|Placebo Group|Maalox and bitter mixture
533870|NCT00679289|B4|Baseline|Total|Total of all reporting groups
536209|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
533873|NCT00679289|B1|Baseline|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533874|NCT00679289|P3|Participant Flow|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533875|NCT00679289|P2|Participant Flow|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533876|NCT00679289|P1|Participant Flow|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533877|NCT00679289|O3|Outcome|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533878|NCT00679289|O2|Outcome|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533879|NCT00679289|O1|Outcome|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533880|NCT00679289|O3|Outcome|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533881|NCT00679289|O2|Outcome|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533882|NCT00679289|O1|Outcome|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533883|NCT00679289|O3|Outcome|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533884|NCT00679289|O2|Outcome|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533885|NCT00679289|O1|Outcome|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533886|NCT00679289|O3|Outcome|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533887|NCT00679289|O2|Outcome|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533888|NCT00679289|O1|Outcome|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533889|NCT00679289|O2|Outcome|Total|All evaluable patients in Cohorts 1, 2, and 3 combined
533890|NCT00679289|O1|Outcome|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533891|NCT00679289|E3|Reported Event|Cohort 3|"KW2871: 20 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533892|NCT00679289|E2|Reported Event|Cohort 2|"KW2871: 10 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533893|NCT00679289|E1|Reported Event|Cohort 1|"KW2871: 5 mg/m^2 IV every 2 weeks~HDI: 20 MU/m^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m^2 SC 3 days/week"
533894|NCT00679263|B4|Baseline|Total|Total of all reporting groups
533895|NCT00679263|B3|Baseline|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
533896|NCT00679263|B2|Baseline|Placebo|MN-221 Placebo continuous infusion
533897|NCT00679263|B1|Baseline|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
533898|NCT00679263|P3|Participant Flow|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
533899|NCT00679263|P2|Participant Flow|Placebo|MN-221 Placebo continuous infusion
533900|NCT00679263|P1|Participant Flow|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
533901|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
533902|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
533903|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
533904|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
533905|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
533906|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
533907|NCT00679263|E3|Reported Event|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
533908|NCT00679263|E2|Reported Event|Placebo|MN-221 Placebo continuous infusion
533909|NCT00679263|E1|Reported Event|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
533910|NCT00679211|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533911|NCT00679211|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533912|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533913|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533914|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533915|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533916|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533917|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533918|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533919|NCT00679211|O2|Outcome|9 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533920|NCT00679211|O1|Outcome|6 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533921|NCT00679211|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
533922|NCT00679172|B6|Baseline|Total|Total of all reporting groups
533923|NCT00679172|B5|Baseline|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533924|NCT00679172|B4|Baseline|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533925|NCT00679172|B3|Baseline|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533926|NCT00679172|B2|Baseline|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533927|NCT00679172|B1|Baseline|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533928|NCT00679172|P5|Participant Flow|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533929|NCT00679172|P4|Participant Flow|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533930|NCT00679172|P3|Participant Flow|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533931|NCT00679172|P2|Participant Flow|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533932|NCT00679172|P1|Participant Flow|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533933|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
533934|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533935|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
533936|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533937|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
533938|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533939|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533940|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533941|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533942|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533943|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533944|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533945|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533946|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533947|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533948|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533949|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533950|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533951|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533952|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533953|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533954|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533955|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC- ssaV-) ZH9.
533956|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533957|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533958|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533959|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533960|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533961|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533962|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533963|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533968|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533969|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533970|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533971|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533972|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533973|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533974|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533975|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533976|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533977|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533978|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533979|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533980|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533981|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533982|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533983|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533984|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533985|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533986|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533987|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533988|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533989|NCT00679172|E5|Reported Event|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
533990|NCT00679172|E4|Reported Event|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533991|NCT00679172|E3|Reported Event|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533992|NCT00679172|E2|Reported Event|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533993|NCT00679172|E1|Reported Event|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
533994|NCT00679081|B1|Baseline|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
533995|NCT00679081|P1|Participant Flow|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
533996|NCT00679081|O3|Outcome|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
533997|NCT00679081|O2|Outcome|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
533998|NCT00679081|O1|Outcome|CelTx Site|Adverse events occurring at the CelTx site
533999|NCT00679081|E3|Reported Event|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
534000|NCT00679081|E2|Reported Event|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
534001|NCT00679081|E1|Reported Event|CelTx Site|Adverse events occurring at the CelTx site
534002|NCT00679055|B3|Baseline|Total|Total of all reporting groups
534003|NCT00679055|B2|Baseline|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
534004|NCT00679055|B1|Baseline|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
534005|NCT00679055|P2|Participant Flow|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
534006|NCT00679055|P1|Participant Flow|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
534007|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
534008|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
534009|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
534010|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
534011|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
534012|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
534013|NCT00679055|E2|Reported Event|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
534014|NCT00679055|E1|Reported Event|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
534016|NCT00678899|P1|Participant Flow|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
534017|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
534018|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
534019|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
534020|NCT00678899|O1|Outcome|6 Months Postactivation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
534021|NCT00678899|E1|Reported Event|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
534022|NCT00678886|B3|Baseline|Total|Total of all reporting groups
534023|NCT00678886|B2|Baseline|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534024|NCT00678886|B1|Baseline|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534025|NCT00678886|P4|Participant Flow|Adult (Otelixizumab)|Eligible adult participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg), second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534026|NCT00678886|P3|Participant Flow|Adult (Placebo)|Eligible adult participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive Days. Participants were followed-up for 24 months after the last dose.
534027|NCT00678886|P2|Participant Flow|Adolescent (Otelixizumab)|Eligible adolescent participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 milligram [mg], second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534028|NCT00678886|P1|Participant Flow|Adolescent (Placebo)|Eligible adolescent participants received matching placebo to Otelixizumab administered as intravenous (IV) infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534029|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534030|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534031|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions (as first dose-day 1 of 0.1 mg, second dose-day 2 of 0.2 mg, third dose-day 3 of 0.3 mg, fourth, fifth, sixth, seventh and eight dose on days 4,5,6,7,8 of 0.5 mg per day) 1 infusion per day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg.
534032|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
534033|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534034|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534035|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534036|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534072|NCT00678834|B3|Baseline|Arm 3- Healthy + Tocotrienol 200 mg|Healthy Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
534037|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534038|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534039|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534040|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534041|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534042|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534043|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534044|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534045|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534046|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534047|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions (as first dose-day 1 of 0.1 mg, second dose-day 2 of 0.2 mg, third dose-day 3 of 0.3 mg, fourth, fifth, sixth, seventh and eight dose on days 4,5,6,7,8 of 0.5 mg per day) 1 infusion per day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg.
534048|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
534049|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534050|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose
534051|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534052|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534053|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534054|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534055|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534056|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534057|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534058|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534059|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534060|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534061|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534062|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534063|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534064|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534065|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534066|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534067|NCT00678886|O2|Outcome|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534068|NCT00678886|O1|Outcome|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534069|NCT00678886|E2|Reported Event|Otelixizumab|Eligible participants received Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions as first dose (Day 1 of 0.1 mg, second dose (Day 2 of 0.2 mg), third dose (Day 3 of 0.3 mg), fourth, fifth, sixth, seventh and eight dose (on Days 4,5,6,7,8 of 0.5 mg per Day) 1 infusion per Day over 8 consecutive days . The total amount of Otelixizumab administered was 3.1 mg. Participants were followed-up for 24 months after the last dose.
534070|NCT00678886|E1|Reported Event|Placebo|Eligible participants received matching placebo to Otelixizumab administered as IV infusions, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per Day over 8 consecutive days. Participants were followed-up for 24 months after the last dose.
534071|NCT00678834|B4|Baseline|Total|Total of all reporting groups
534073|NCT00678834|B2|Baseline|Arm 2 - Surgical + Tocopherol 200 mg|Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
534074|NCT00678834|B1|Baseline|Arm 1- Surgical + Tocotrienol 200 mg|Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
534075|NCT00678834|P3|Participant Flow|Arm 3- Healthy +Tocotrienol 400 mg|Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day.
534076|NCT00678834|P2|Participant Flow|Arm 2- Surgery + Tocopherol 200 mg|Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
534077|NCT00678834|P1|Participant Flow|Arm 1- Surgery + Tocotrienol 200 mg|Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
534078|NCT00678834|O13|Outcome|Arm 3: Healthy, Blood, Week 12|Blood levels of aTE after 12 weeks of supplementation (400mg/d)
534079|NCT00678834|O12|Outcome|Arm 3: Healthy, Skin, Week 0|baseline skin levels of aTE prior to supplementation
534080|NCT00678834|O11|Outcome|Arm 3: Healthy, Skin, Week 12|skin levels of aTE after 12 weeks of supplementation (400mg/d)
534081|NCT00678834|O10|Outcome|Arm 3: Healthy, Blood, Week 6|Blood levels of aTE after 6 weeks of supplementation (400mg/d)
534082|NCT00678834|O9|Outcome|Arm 3: Healthy, Blood, Week 0|Baseline blood levels of aTE prior to supplementation
534083|NCT00678834|O8|Outcome|Arm 2: Surgical, Liver|liver aTCP levels after supplementation (400mg/d)
534084|NCT00678834|O7|Outcome|Arm 2: Surgical, Heart|heart aTCP levels after supplementation (400mg/d)
534085|NCT00678834|O6|Outcome|Arm 2: Surgical, Brain|brain aTCP levels after supplementation (400mg/d)
534086|NCT00678834|O5|Outcome|Arm 2: Surgical, Adipose|adipose aTCP levels after supplementation (400mg/d)
534087|NCT00678834|O4|Outcome|Arm 1: Surgical, Liver|liver aTE levels after supplementation (400mg/d)
534088|NCT00678834|O3|Outcome|Arm 1: Surgical, Heart|heart aTE levels after supplementation (400mg/d)
534089|NCT00678834|O2|Outcome|Arm 1: Surgical, Brain|brain aTE levels after supplementation (400mg/d)
534090|NCT00678834|O1|Outcome|Arm 1: Surgical, Adipose|adipose aTE levels after supplementation (400mg/d)
534091|NCT00678834|E3|Reported Event|Arm 3|Healthy patients to take either Tocotrienol or Tocopherol: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
534092|NCT00678834|E2|Reported Event|Arm 2|Surgery patients to take Tocopherol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
534093|NCT00678834|E1|Reported Event|Arm 1|Surgery patients to take Tocotrienol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
534094|NCT00678795|B3|Baseline|Total|Total of all reporting groups
534095|NCT00678795|B2|Baseline|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534096|NCT00678795|B1|Baseline|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534097|NCT00678795|P2|Participant Flow|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534098|NCT00678795|P1|Participant Flow|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534099|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534100|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534101|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534102|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534103|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534104|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534105|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534106|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534107|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534108|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534109|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534110|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534111|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534112|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534113|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
536210|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
534114|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534115|NCT00678795|E2|Reported Event|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
534116|NCT00678795|E1|Reported Event|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
534117|NCT00678691|B3|Baseline|Total|Total of all reporting groups
534118|NCT00678691|B2|Baseline|A,2 Matching Placebo|placebo
534119|NCT00678691|B1|Baseline|A,1 Armodafinil Study Drug|armodafinil
534120|NCT00678691|P2|Participant Flow|A,2 Matching Placebo|placebo
534121|NCT00678691|P1|Participant Flow|A,1 Armodafinil Study Drug 50-250mg Flexible Dose|armodafinil
534122|NCT00678691|O2|Outcome|A,2 Matching Placebo|placebo
534123|NCT00678691|O1|Outcome|A,1 Armodafinil Study Drug|armodafinil
534124|NCT00678691|E2|Reported Event|A,2 Matching Placebo|placebo
534125|NCT00678691|E1|Reported Event|A,1 Armodafinil Study Drug|armodafinil
534126|NCT00678652|B5|Baseline|Total|Total of all reporting groups
534127|NCT00678652|B4|Baseline|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534128|NCT00678652|B3|Baseline|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534129|NCT00678652|B2|Baseline|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534130|NCT00678652|B1|Baseline|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534131|NCT00678652|P4|Participant Flow|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534132|NCT00678652|P3|Participant Flow|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534133|NCT00678652|P2|Participant Flow|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534134|NCT00678652|P1|Participant Flow|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534135|NCT00678652|O4|Outcome|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534136|NCT00678652|O3|Outcome|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534137|NCT00678652|O2|Outcome|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534138|NCT00678652|O1|Outcome|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534139|NCT00678652|O4|Outcome|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534161|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534140|NCT00678652|O3|Outcome|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534141|NCT00678652|O2|Outcome|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534142|NCT00678652|O1|Outcome|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534143|NCT00678652|O4|Outcome|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534144|NCT00678652|O3|Outcome|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534145|NCT00678652|O2|Outcome|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534146|NCT00678652|O1|Outcome|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534147|NCT00678652|O4|Outcome|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534148|NCT00678652|O3|Outcome|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534149|NCT00678652|O2|Outcome|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534150|NCT00678652|O1|Outcome|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534151|NCT00678652|E4|Reported Event|75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant~75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534152|NCT00678652|E3|Reported Event|50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant~50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534153|NCT00678652|E2|Reported Event|25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant~25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534154|NCT00678652|E1|Reported Event|10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine|"Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant~10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study"
534155|NCT00678639|B3|Baseline|Total|Total of all reporting groups
534156|NCT00678639|B2|Baseline|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
534157|NCT00678639|B1|Baseline|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534158|NCT00678639|P2|Participant Flow|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
534159|NCT00678639|P1|Participant Flow|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534160|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
534162|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
534163|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534164|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit- Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534165|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
534166|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534167|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
534168|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534169|NCT00678639|E2|Reported Event|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
534170|NCT00678639|E1|Reported Event|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
534171|NCT00678587|B3|Baseline|Total|Total of all reporting groups
534172|NCT00678587|B2|Baseline|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534173|NCT00678587|B1|Baseline|Placebo|Matching placebo
534174|NCT00678587|P2|Participant Flow|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534175|NCT00678587|P1|Participant Flow|Placebo|Matching placebo
534176|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534177|NCT00678587|O1|Outcome|Placebo|Matching placebo
534178|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534179|NCT00678587|O1|Outcome|Placebo|Matching placebo
534180|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534181|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534182|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534183|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534184|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534185|NCT00678587|O1|Outcome|Placebo|Matching placebo
534186|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534187|NCT00678587|O1|Outcome|Placebo|Matching placebo
534188|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534189|NCT00678587|O1|Outcome|Placebo|Matching placebo
534190|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534191|NCT00678587|O1|Outcome|Placebo|Matching placebo
534192|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534193|NCT00678587|O1|Outcome|Placebo|Matching placebo
534194|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534195|NCT00678587|O1|Outcome|Placebo|Matching placebo
534196|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534197|NCT00678587|O1|Outcome|Placebo|Matching placebo
534198|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534199|NCT00678587|O1|Outcome|Placebo|Matching placebo
534200|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534201|NCT00678587|O1|Outcome|Placebo|Matching placebo
534202|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534203|NCT00678587|O1|Outcome|Placebo|Matching placebo
534204|NCT00678587|E2|Reported Event|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
534205|NCT00678587|E1|Reported Event|Placebo|Matching placebo
534206|NCT00678574|B3|Baseline|Total|Total of all reporting groups
534207|NCT00678574|B2|Baseline|Healthy Controls|No intervention was provided to the healthy control group.
534208|NCT00678574|B1|Baseline|PMDD Group|Fluoxetine 20 mg daily by mouth for 2-3 months to the PMDD group
534209|NCT00678574|P2|Participant Flow|Healthy Controls|Participants who did not qualify for a diagnosis of PMDD and did not receive drug treatment.
534210|NCT00678574|P1|Participant Flow|PMDD|Participants who qualified as having PMDD received fluoxetine 20 mg daily by mouth for 2-3 months
534211|NCT00678574|O2|Outcome|No Intervention|No intervention was provided in the healthy control group.
534212|NCT00678574|O1|Outcome|Fluoxetine|Fluoxetine 20 mg daily by mouth for 2-3 months in PMDD group
534213|NCT00678574|E2|Reported Event|No Treatment|Healthy controls received no treatment.
534214|NCT00678574|E1|Reported Event|Fluoxetine|Fluoxetine 20 mg daily by mouth for 2-3 months in PMDD group
534215|NCT00678535|B3|Baseline|Total|Total of all reporting groups
534216|NCT00678535|B2|Baseline|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534217|NCT00678535|B1|Baseline|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534287|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534218|NCT00678535|P2|Participant Flow|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534219|NCT00678535|P1|Participant Flow|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534220|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534221|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534222|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534223|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534224|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534225|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534226|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534227|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534228|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534229|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534230|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534231|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534232|NCT00678535|E2|Reported Event|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534233|NCT00678535|E1|Reported Event|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
534234|NCT00678470|B1|Baseline|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
534235|NCT00678470|P1|Participant Flow|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
534236|NCT00678470|O1|Outcome|Intralesional Alefacept Followed by Intramuscular Alefacept.|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections to a single plaque (week 0). The plaques will be scored for response to intralesional injection (week 2). All patients will then receive intramuscular injection (week 2). The patients will then be scored for response to intramuscular injection (week 14). The number of patients who responded to both intralesional and intramuscular injection will be tabulated."
534288|NCT00678392|E2|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534677|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534237|NCT00678470|E1|Reported Event|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
534238|NCT00678418|B3|Baseline|Total|Total of all reporting groups
534239|NCT00678418|B2|Baseline|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534240|NCT00678418|B1|Baseline|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534241|NCT00678418|P2|Participant Flow|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534242|NCT00678418|P1|Participant Flow|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534243|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534244|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534245|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534246|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534247|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534248|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534249|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534250|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534251|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534252|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534253|NCT00678418|E2|Reported Event|Placebo|Single intramuscular (IM) injection administered every 4 weeks
534254|NCT00678418|E1|Reported Event|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
534255|NCT00678392|B3|Baseline|Total|Total of all reporting groups
534256|NCT00678392|B2|Baseline|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534257|NCT00678392|B1|Baseline|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534258|NCT00678392|P2|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534259|NCT00678392|P1|Participant Flow|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534260|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534261|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534262|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534263|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534264|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534265|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534266|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534267|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534268|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534269|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534270|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534271|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534272|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534273|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534274|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534275|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534276|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534277|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534278|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534279|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534280|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534281|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534282|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534283|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534284|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534285|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534286|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
534678|NCT00677365|O1|Outcome|Placebo|Placebo Group
534289|NCT00678392|E1|Reported Event|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
534290|NCT00678379|B4|Baseline|Total|Total of all reporting groups
534291|NCT00678379|B3|Baseline|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534292|NCT00678379|B2|Baseline|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534293|NCT00678379|B1|Baseline|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534294|NCT00678379|P3|Participant Flow|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534295|NCT00678379|P2|Participant Flow|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534296|NCT00678379|P1|Participant Flow|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534297|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534298|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534299|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534300|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534301|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534302|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534303|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534304|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534305|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534306|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534307|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534308|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534309|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534310|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534311|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534312|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534313|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534314|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534384|NCT00678288|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534679|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534315|NCT00678379|O3|Outcome|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534316|NCT00678379|O2|Outcome|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534317|NCT00678379|O1|Outcome|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534318|NCT00678379|E3|Reported Event|Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg|"Lidocaine 1% + Bupivacaine o.5% + Clondine 25mcg~lidocaine + bupivacaine + clonidine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)"
534319|NCT00678379|E2|Reported Event|Lidocaine (1%) + Bupivacaine 0.5%|"Lidocaine (1%) + Bupivacaine 0.5%~lidocaine + bupivacaine: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~B - lidocaine (1%) + bupivacaine (0.5%)"
534320|NCT00678379|E1|Reported Event|Normal Saline|"Normal Saline~normal saline: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy with one of three injections.~A - normal saline"
534321|NCT00678301|B3|Baseline|Total|Total of all reporting groups
534322|NCT00678301|B2|Baseline|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534323|NCT00678301|B1|Baseline|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534324|NCT00678301|P2|Participant Flow|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534325|NCT00678301|P1|Participant Flow|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534326|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534327|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534328|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534329|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534330|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534331|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534332|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534333|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534680|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534681|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534334|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534335|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534336|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534337|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534338|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534339|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534340|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534341|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534342|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534343|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534344|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534345|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534346|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534347|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534348|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534349|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534425|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534350|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534351|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534352|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534353|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534354|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534355|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534356|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534357|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534358|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534359|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534360|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534361|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534362|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534363|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534364|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534365|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534426|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534427|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534366|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534367|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534368|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534369|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534370|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534371|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534372|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534373|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534374|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534375|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534376|NCT00678301|O2|Outcome|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534377|NCT00678301|O1|Outcome|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534378|NCT00678301|E2|Reported Event|Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally.
534379|NCT00678301|E1|Reported Event|Synflorix™ + Zilbrix™ Hib + Polio Sabin™|Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally.
534380|NCT00678288|B3|Baseline|Total|Total of all reporting groups
534381|NCT00678288|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534382|NCT00678288|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534383|NCT00678288|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534673|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534385|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534386|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534387|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534388|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534389|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534390|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534391|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534392|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534393|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534394|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534395|NCT00678288|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
534396|NCT00678288|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
534397|NCT00678249|B4|Baseline|Total|Total of all reporting groups
534398|NCT00678249|B3|Baseline|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534399|NCT00678249|B2|Baseline|PTA Only|Percutaneous Transluminal Angioplasty
534400|NCT00678249|B1|Baseline|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534401|NCT00678249|P3|Participant Flow|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534402|NCT00678249|P2|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty
534403|NCT00678249|P1|Participant Flow|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534404|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534405|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534406|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534407|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534408|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534409|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534410|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534411|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534412|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534413|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534414|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534415|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534416|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534417|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534418|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534419|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534420|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534421|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534422|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534423|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534424|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534428|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534429|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
534430|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534431|NCT00678249|E3|Reported Event|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
534432|NCT00678249|E2|Reported Event|PTA Only|Percutaneous Transluminal Angioplasty
534433|NCT00678249|E1|Reported Event|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
534434|NCT00678210|B5|Baseline|Total|Total of all reporting groups
534435|NCT00678210|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534436|NCT00678210|B3|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534437|NCT00678210|B2|Baseline|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534438|NCT00678210|B1|Baseline|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534439|NCT00678210|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534440|NCT00678210|P3|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534441|NCT00678210|P2|Participant Flow|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534442|NCT00678210|P1|Participant Flow|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 milligram (mg) orally twice daily for 12 weeks.
534443|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534444|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534445|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534446|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534447|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534448|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534449|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534450|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534451|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534452|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534453|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534454|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534455|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534456|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534457|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534458|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534459|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534460|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534461|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534462|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534463|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534464|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534465|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534466|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534467|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534468|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534469|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534470|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534471|NCT00678210|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
534472|NCT00678210|E3|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
534473|NCT00678210|E2|Reported Event|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
534474|NCT00678210|E1|Reported Event|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
534475|NCT00678041|B3|Baseline|Total|Total of all reporting groups
534476|NCT00678041|B2|Baseline|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
534477|NCT00678041|B1|Baseline|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
534674|NCT00677365|O1|Outcome|Placebo|Placebo Group
534478|NCT00678041|P2|Participant Flow|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
534479|NCT00678041|P1|Participant Flow|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
534480|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
534481|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
534482|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
534483|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
534484|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
534485|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
534486|NCT00678041|O2|Outcome|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
534487|NCT00678041|O1|Outcome|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
534488|NCT00678041|E2|Reported Event|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
534489|NCT00678041|E1|Reported Event|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
534490|NCT00678015|B1|Baseline|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
534491|NCT00678015|P1|Participant Flow|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
534492|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
534493|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
534494|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
534495|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
534496|NCT00678015|E1|Reported Event|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
534497|NCT00677924|B3|Baseline|Total|Total of all reporting groups
534498|NCT00677924|B2|Baseline|Zalutumumab 16 mg/kg|
534499|NCT00677924|B1|Baseline|Zalatumumab 8 mg/kg|
534500|NCT00677924|P2|Participant Flow|Zalutumumab 16 mg/kg|
534501|NCT00677924|P1|Participant Flow|Zalatumumab 8 mg/kg|
534502|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
534503|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
534504|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
534505|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
534506|NCT00677924|E2|Reported Event|Zalutumumab 16 mg/kg|
534507|NCT00677924|E1|Reported Event|Zalatumumab 8 mg/kg|
534508|NCT00677898|B3|Baseline|Total|Total of all reporting groups
534509|NCT00677898|B2|Baseline|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534510|NCT00677898|B1|Baseline|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534511|NCT00677898|P2|Participant Flow|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534512|NCT00677898|P1|Participant Flow|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534513|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534514|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534515|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534675|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534516|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534517|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534518|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534519|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534520|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534521|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534522|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534523|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534524|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534525|NCT00677898|E2|Reported Event|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
534526|NCT00677898|E1|Reported Event|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
534527|NCT00677833|B5|Baseline|Total|Total of all reporting groups
534528|NCT00677833|B4|Baseline|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534529|NCT00677833|B3|Baseline|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534530|NCT00677833|B2|Baseline|Cohort 1: Artemether + Lumefantrine|"Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2.~Cohort 1 included participants between >=5 years of age and <=12 years of age."
534531|NCT00677833|B1|Baseline|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between >=5 years of age and <=12 years of age.
534532|NCT00677833|P4|Participant Flow|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534533|NCT00677833|P3|Participant Flow|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534534|NCT00677833|P2|Participant Flow|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
534535|NCT00677833|P1|Participant Flow|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (>=) 5 years of age and less than or equal to (<=) 12 years of age.
534536|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534537|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534538|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534676|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534539|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534540|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534541|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534542|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534543|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534544|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534545|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534546|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534547|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534548|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534549|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534550|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534551|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534552|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534553|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534554|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534555|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534556|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534682|NCT00677365|O1|Outcome|Placebo|Placebo Group
534557|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534558|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534559|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534560|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534561|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534562|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534563|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534564|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534565|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534566|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534567|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534568|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534569|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534570|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534571|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534572|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534573|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534574|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
536211|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
534575|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534576|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534577|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534578|NCT00677833|E4|Reported Event|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534579|NCT00677833|E3|Reported Event|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
534580|NCT00677833|E2|Reported Event|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
534581|NCT00677833|E1|Reported Event|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between >=5 years of age and <=12 years of age.
534582|NCT00677820|B3|Baseline|Total|Total of all reporting groups
534583|NCT00677820|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534584|NCT00677820|B1|Baseline|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534585|NCT00677820|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534586|NCT00677820|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534587|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534588|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534589|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534590|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534591|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534592|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534593|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534594|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534595|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534596|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534597|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534598|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534599|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534600|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534601|NCT00677820|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
534602|NCT00677820|E1|Reported Event|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
534603|NCT00677807|B4|Baseline|Total|Total of all reporting groups
534604|NCT00677807|B3|Baseline|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534605|NCT00677807|B2|Baseline|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534606|NCT00677807|B1|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534607|NCT00677807|P3|Participant Flow|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534608|NCT00677807|P2|Participant Flow|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534609|NCT00677807|P1|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534610|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534611|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534612|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534613|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534614|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534615|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534616|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534617|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534618|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534619|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534620|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534621|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534622|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534623|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534624|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534625|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534626|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534627|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534628|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534629|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534630|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534631|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534632|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534633|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534634|NCT00677807|E3|Reported Event|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534635|NCT00677807|E2|Reported Event|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534636|NCT00677807|E1|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
534637|NCT00677690|B3|Baseline|Total|Total of all reporting groups
534638|NCT00677690|B2|Baseline|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534639|NCT00677690|B1|Baseline|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534640|NCT00677690|P2|Participant Flow|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534641|NCT00677690|P1|Participant Flow|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534642|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534643|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534644|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534645|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534646|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534647|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534648|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534649|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534650|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534651|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534652|NCT00677690|E2|Reported Event|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
534653|NCT00677690|E1|Reported Event|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
534654|NCT00677534|B1|Baseline|Cholecalciferol 50,000 U|Vitamin D
534655|NCT00677534|P1|Participant Flow|Cholecalciferol 50,000 U|Vitamin D
534656|NCT00677534|O1|Outcome|Cholecalciferol 50,000 U|Vitamin D
534657|NCT00677534|E1|Reported Event|Cholecalciferol 50,000 U|Vitamin D
534658|NCT00677365|B5|Baseline|Total|Total of all reporting groups
534659|NCT00677365|B4|Baseline|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534660|NCT00677365|B3|Baseline|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534661|NCT00677365|B2|Baseline|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534662|NCT00677365|B1|Baseline|Placebo|Placebo Group
534663|NCT00677365|P4|Participant Flow|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534664|NCT00677365|P3|Participant Flow|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534665|NCT00677365|P2|Participant Flow|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534666|NCT00677365|P1|Participant Flow|Placebo|Placebo Group
534667|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534668|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534669|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534670|NCT00677365|O1|Outcome|Placebo|Placebo Group
534671|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534672|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534683|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534684|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534685|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534686|NCT00677365|O1|Outcome|Placebo|Placebo Group
534687|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534688|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534689|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534690|NCT00677365|O1|Outcome|Placebo|Placebo Group
534691|NCT00677365|E4|Reported Event|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
534692|NCT00677365|E3|Reported Event|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
534693|NCT00677365|E2|Reported Event|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
534694|NCT00677365|E1|Reported Event|Placebo|Placebo Group
534695|NCT00677352|B3|Baseline|Total|Total of all reporting groups
534696|NCT00677352|B2|Baseline|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534697|NCT00677352|B1|Baseline|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534698|NCT00677352|P2|Participant Flow|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534699|NCT00677352|P1|Participant Flow|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534700|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534701|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534702|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534703|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534704|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534720|NCT00677235|P1|Participant Flow|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534721|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534722|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534705|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534706|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534707|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534708|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534709|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534710|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534711|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534712|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534713|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534714|NCT00677352|E2|Reported Event|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
534715|NCT00677352|E1|Reported Event|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
534716|NCT00677235|B3|Baseline|Total|Total of all reporting groups
534717|NCT00677235|B2|Baseline|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534718|NCT00677235|B1|Baseline|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534719|NCT00677235|P2|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only
534723|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534724|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534725|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534726|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534727|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534728|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534729|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534730|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534731|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534732|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534733|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534734|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534735|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534736|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534737|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534738|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534739|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534740|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534741|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534742|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534743|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534744|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534745|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534746|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534747|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534748|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534749|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534750|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534751|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534752|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534753|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534754|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534755|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534756|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534757|NCT00677235|E2|Reported Event|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
534758|NCT00677235|E1|Reported Event|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
534759|NCT00677092|B1|Baseline|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534760|NCT00677092|P1|Participant Flow|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if participant developed gastrointestinal intolerance or alopecia.
534761|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534762|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534763|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534922|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534764|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534765|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534766|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 milligrams (mg) orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534767|NCT00677092|E1|Reported Event|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
534768|NCT00677014|B4|Baseline|Total|Total of all reporting groups
534769|NCT00677014|B3|Baseline|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
534770|NCT00677014|B2|Baseline|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
534771|NCT00677014|B1|Baseline|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
534772|NCT00677014|P3|Participant Flow|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
534773|NCT00677014|P2|Participant Flow|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
534774|NCT00677014|P1|Participant Flow|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
534775|NCT00677014|O3|Outcome|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
534776|NCT00677014|O2|Outcome|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
534777|NCT00677014|O1|Outcome|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
534778|NCT00677014|E3|Reported Event|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
534779|NCT00677014|E2|Reported Event|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
534780|NCT00677014|E1|Reported Event|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
534781|NCT00676897|B3|Baseline|Total|Total of all reporting groups
534782|NCT00676897|B2|Baseline|Placebo Group|Placebo: Corn Starch
534783|NCT00676897|B1|Baseline|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
534784|NCT00676897|P2|Participant Flow|Placebo Group|Placebo: Corn Starch
534785|NCT00676897|P1|Participant Flow|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
534786|NCT00676897|O2|Outcome|Placebo Group|Placebo: Corn Starch
534787|NCT00676897|O1|Outcome|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
534788|NCT00676897|O2|Outcome|Placebo Group|Placebo: Corn Starch
534789|NCT00676897|O1|Outcome|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
534790|NCT00676897|E2|Reported Event|Placebo Group|Placebo: Corn Starch
534791|NCT00676897|E1|Reported Event|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
534792|NCT00676806|B3|Baseline|Total|Total of all reporting groups
534793|NCT00676806|B2|Baseline|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
534794|NCT00676806|B1|Baseline|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
534795|NCT00676806|P2|Participant Flow|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
534796|NCT00676806|P1|Participant Flow|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
534797|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~1/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
534798|NCT00676806|O1|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.~2/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
534799|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
534800|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
534801|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
534802|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
534803|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
534804|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
534805|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
534806|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
534807|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~1/2 evaluable subjects engrafted at +45 and +90 days."
534808|NCT00676806|O1|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.~2/2 evaluable subjects engrafted at +45 and +90 days."
534809|NCT00676806|E2|Reported Event|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
534810|NCT00676806|E1|Reported Event|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
534811|NCT00676793|B1|Baseline|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
534812|NCT00676793|P1|Participant Flow|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
534813|NCT00676793|O1|Outcome|ECGC and Breast Cancer|The effect of ECGC extract on biomarkers in breast cancer.
534814|NCT00676793|O1|Outcome|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
534815|NCT00676793|E1|Reported Event|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
534816|NCT00676780|B1|Baseline|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
534817|NCT00676780|P1|Participant Flow|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
534818|NCT00676780|O1|Outcome|ECGC Extract|Epigallocatechin Gallate (ECGC) Single arm for a phase II study.
534819|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of ECGC polyphenol extract from green tea on biomarkers in patients with prostate cancer.
534820|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of Epigallocatechin Gallate (ECGC) polyphenol extract from green tea on biomarkers in patients with prostate cancer.
534821|NCT00676780|E1|Reported Event|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
534822|NCT00676715|B5|Baseline|Total|Total of all reporting groups
534823|NCT00676715|B4|Baseline|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534824|NCT00676715|B3|Baseline|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534825|NCT00676715|B2|Baseline|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534826|NCT00676715|B1|Baseline|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534827|NCT00676715|P4|Participant Flow|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534828|NCT00676715|P3|Participant Flow|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534923|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534924|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534829|NCT00676715|P2|Participant Flow|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534830|NCT00676715|P1|Participant Flow|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534831|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534832|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534833|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534834|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534835|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534836|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534837|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534838|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534839|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534840|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534841|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534842|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534843|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534844|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534845|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534846|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534847|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534848|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534925|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534926|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534849|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534850|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534851|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534852|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534853|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534854|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534855|NCT00676715|E4|Reported Event|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534856|NCT00676715|E3|Reported Event|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
534857|NCT00676715|E2|Reported Event|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
534858|NCT00676715|E1|Reported Event|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
534859|NCT00676689|B1|Baseline|SAPIEN THV|
534860|NCT00676689|P1|Participant Flow|SAPIEN THV|
534861|NCT00676689|O1|Outcome|SAPIEN THV|
534862|NCT00676689|O1|Outcome|SAPIEN THV|
534863|NCT00676689|O1|Outcome|SAPIEN THV|
534864|NCT00676689|E1|Reported Event|SAPIEN THV|
534865|NCT00676676|B1|Baseline|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
534866|NCT00676676|P1|Participant Flow|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
534867|NCT00676676|O1|Outcome|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
534868|NCT00676676|E1|Reported Event|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
534869|NCT00676650|B3|Baseline|Total|Total of all reporting groups
534870|NCT00676650|B2|Baseline|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534871|NCT00676650|B1|Baseline|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534872|NCT00676650|P2|Participant Flow|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534873|NCT00676650|P1|Participant Flow|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534874|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534875|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534876|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534927|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534928|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534929|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534877|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534878|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534879|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534880|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534881|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534882|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534883|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534884|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534885|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534886|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534887|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534888|NCT00676650|E2|Reported Event|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
534889|NCT00676650|E1|Reported Event|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
534890|NCT00676585|B3|Baseline|Total|Total of all reporting groups
534891|NCT00676585|B2|Baseline|Intervention|Hydrocortisone
534892|NCT00676585|B1|Baseline|Control|Normal Saline
534893|NCT00676585|P2|Participant Flow|Intervention|Hydrocortisone
534894|NCT00676585|P1|Participant Flow|Control|Normal Saline
534895|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
534896|NCT00676585|O1|Outcome|Control|Normal Saline
534897|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
534898|NCT00676585|O1|Outcome|Control|Normal Saline
534899|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
534900|NCT00676585|O1|Outcome|Control|Normal Saline
534901|NCT00676585|E2|Reported Event|Intervention|Hydrocortisone
534902|NCT00676585|E1|Reported Event|Control|Normal Saline
534903|NCT00676520|B1|Baseline|Subjects Receiving the XIENCE V EECSS|
534904|NCT00676520|P1|Participant Flow|Subjects Receiving the XIENCE V EECSS|
534905|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
534906|NCT00676520|O4|Outcome|Treatment Satisfaction|
534907|NCT00676520|O3|Outcome|Angina Frequency|
534908|NCT00676520|O2|Outcome|Angina Stability|
534909|NCT00676520|O1|Outcome|Physical Limitations|
534910|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
534911|NCT00676520|O4|Outcome|Treatment Satisfaction|
534912|NCT00676520|O3|Outcome|Angina Frequency|
534913|NCT00676520|O2|Outcome|Angina Stability|
534914|NCT00676520|O1|Outcome|Physical Limitations|
534915|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
534916|NCT00676520|O4|Outcome|Treatment Satisfaction|
534917|NCT00676520|O3|Outcome|Angina Frequency|
534918|NCT00676520|O2|Outcome|Angina Stability|
534919|NCT00676520|O1|Outcome|Physical Limitations|
534920|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534921|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
534959|NCT00676520|E1|Reported Event|Subjects Receiving the XIENCE V EECSS|
534960|NCT00676494|B1|Baseline|All Patients|Patients meeting eligibility criteria and enrolled in the study.
534961|NCT00676494|P1|Participant Flow|All Patients|Patients meeting eligibility criteria and enrolled in the study.
534962|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
534963|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
534964|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
534965|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
534966|NCT00676455|B1|Baseline|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
534967|NCT00676455|P1|Participant Flow|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
534968|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
534969|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
534970|NCT00676455|E1|Reported Event|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
534971|NCT00676403|B7|Baseline|Total|Total of all reporting groups
534972|NCT00676403|B6|Baseline|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
534973|NCT00676403|B5|Baseline|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
534974|NCT00676403|B4|Baseline|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
534975|NCT00676403|B3|Baseline|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
534976|NCT00676403|B2|Baseline|Pregabalin 50 mg|Single daily 50 mg oral dose.
534977|NCT00676403|B1|Baseline|Placebo|Single daily oral dose.
534978|NCT00676403|P6|Participant Flow|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
534979|NCT00676403|P5|Participant Flow|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
534980|NCT00676403|P4|Participant Flow|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
534981|NCT00676403|P3|Participant Flow|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
534982|NCT00676403|P2|Participant Flow|Pregabalin 50 mg|Single daily 50 mg oral dose.
534983|NCT00676403|P1|Participant Flow|Placebo|Single daily oral dose.
534984|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
534985|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
534986|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
534987|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
534988|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
534989|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
534990|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
534991|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
534992|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
534993|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
534994|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
534995|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
534996|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
534997|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
534998|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
534999|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535000|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535001|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535002|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535003|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535004|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535005|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535006|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535007|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535008|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535009|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535427|NCT00675766|B4|Baseline|Group 4|HIV-negative controls 18-40 years old
535010|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535011|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535012|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535013|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535014|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535015|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535016|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535017|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535018|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535019|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535020|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535021|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535022|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535023|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535024|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535025|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535026|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535027|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535028|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535029|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535030|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535031|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535032|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535033|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535034|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535035|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535036|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535037|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535038|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535039|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535040|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535041|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535042|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535043|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535044|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535045|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535046|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535047|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535048|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535049|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535050|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535051|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535052|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535053|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535054|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535055|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535056|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535057|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535058|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535059|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535060|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535061|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535062|NCT00676403|O6|Outcome|Pregablin 450 mg/Day|
535063|NCT00676403|O5|Outcome|Pregabalin 300 mg/Day|
535064|NCT00676403|O4|Outcome|Pregabalin 150 mg/Day|
535065|NCT00676403|O3|Outcome|Pregabalin 100 mg/Day|
535066|NCT00676403|O2|Outcome|Pregabalin 50 mg/Day|
535068|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535069|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535070|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535071|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535072|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535073|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535074|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535075|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535076|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535077|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535078|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535079|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535080|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535081|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535082|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535083|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535084|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535085|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535086|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535087|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535088|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535089|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535090|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535091|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535092|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535093|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535094|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535095|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535096|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535097|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535098|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535099|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535100|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535101|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535102|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
535103|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
535104|NCT00676403|E6|Reported Event|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
535105|NCT00676403|E5|Reported Event|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
535106|NCT00676403|E4|Reported Event|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
535107|NCT00676403|E3|Reported Event|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
535108|NCT00676403|E2|Reported Event|Pregabalin 50 mg|Single daily 50 mg oral dose.
535109|NCT00676403|E1|Reported Event|Placebo|Single daily oral dose.
535110|NCT00676364|B3|Baseline|Total|Total of all reporting groups
535111|NCT00676364|B2|Baseline|Investigational Group|Investigational group receiving blinded 4% lidocaine cream
535112|NCT00676364|B1|Baseline|ControI Group Receiving Placebo Cream Before Venipuncture|Experimential group receiving medicated topical cream prior to venipuncture
535113|NCT00676364|P2|Participant Flow|Investigational Group Receiving 4% Lidocaine|Investigational group receiving blinded 4% lidocaine cream under occlusive dressing for 15 mins prior to venipuncture
535114|NCT00676364|P1|Participant Flow|ControI Group Receiving Placebo Cream|Control group receiving blinded placebo cream under occlusive dressing prior to venipuncture
535115|NCT00676364|O2|Outcome|Investigational Group Receiving 4% Lidocaine Cream|The investigational group received blinded 4% lidocaine cream under occlusive dressing for 15 minutes prior to venipuncture.
535116|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|The control group received blinded placebo cream under occlusive dressing for 15 minutes prior to venipuncture.
535117|NCT00676364|O2|Outcome|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
535118|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
535119|NCT00676364|E2|Reported Event|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
535120|NCT00676364|E1|Reported Event|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
535121|NCT00676338|B5|Baseline|Total|Total of all reporting groups
535122|NCT00676338|B4|Baseline|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535123|NCT00676338|B3|Baseline|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535124|NCT00676338|B2|Baseline|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535125|NCT00676338|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535126|NCT00676338|P4|Participant Flow|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535127|NCT00676338|P3|Participant Flow|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535128|NCT00676338|P2|Participant Flow|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535129|NCT00676338|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535130|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535131|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535132|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535133|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535134|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535135|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535136|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535137|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535138|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535139|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535140|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535141|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535142|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535143|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535144|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535145|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535146|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535147|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535148|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535149|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535150|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535151|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535152|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535153|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535154|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535155|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535156|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535157|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535158|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535159|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535160|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535161|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535162|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535163|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535164|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535428|NCT00675766|B3|Baseline|Group 3|HIV-negative controls 50 and older
535165|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535166|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535167|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535168|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535169|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535170|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535171|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535172|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535173|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535174|NCT00676338|E4|Reported Event|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
535175|NCT00676338|E3|Reported Event|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535176|NCT00676338|E2|Reported Event|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
535177|NCT00676338|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
535178|NCT00676208|B3|Baseline|Total|Total of all reporting groups
535179|NCT00676208|B2|Baseline|Comparison|Medical students who do not experience Shared Medical Appointments.
535180|NCT00676208|B1|Baseline|SMA Participants|Medical Students who were assigned to observe Shared Medical Appointments (SMA).
535181|NCT00676208|P2|Participant Flow|Comparison|Medical students who do not experience Shared Medical Appointments during the study period April to August 2008.
535182|NCT00676208|P1|Participant Flow|Intervention|Medical Students who are assigned to observe Shared Medical Appointments.
535183|NCT00676208|O2|Outcome|Comparison|Medical students who do not experience Shared Medical Appointments (SMA).
535184|NCT00676208|O1|Outcome|SMA Particiants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
535185|NCT00676208|O2|Outcome|Comparison|Medical Students who do not experience Shared Medical Appointments.
535186|NCT00676208|O1|Outcome|SMA Participants|Medical students who are assigned to observe Shared Medical Appointments (SMA).
535187|NCT00676208|E2|Reported Event|Comparison|Medical students who do not experience Shared Medical Appointments.
535188|NCT00676208|E1|Reported Event|SMA Participants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
535189|NCT00676195|B1|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
535190|NCT00676195|P1|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
535191|NCT00676195|O1|Outcome|Open-Label|
535192|NCT00676195|O1|Outcome|Open-Label|
535193|NCT00676195|O1|Outcome|Open-Label|
535194|NCT00676195|O1|Outcome|Open-Label|
535195|NCT00676195|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
535196|NCT00676195|E1|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
535197|NCT00676182|B3|Baseline|Total|Total of all reporting groups
535198|NCT00676182|B2|Baseline|Telerehabilitation TBI/PTSD|"Telerehabilitation TBI/PTSD~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD"
535199|NCT00676182|B1|Baseline|Telerehabilitation TBI|"Telerehabilitation TBI~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI"
535200|NCT00676182|P1|Participant Flow|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
535201|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
535202|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
535203|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
535204|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
535205|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for TBI/PTSD"
535206|NCT00676182|O1|Outcome|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
535207|NCT00676182|O3|Outcome|Telerehabilitation 12 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
535208|NCT00676182|O2|Outcome|Telerehabilitation 6 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
535209|NCT00676182|O1|Outcome|Telerehabilitation Baseline|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
535210|NCT00676182|O1|Outcome|Telerehabilitation|"Telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects"
535429|NCT00675766|B2|Baseline|Group 2|HIV-positive adults 18-40 years old
535211|NCT00676182|E1|Reported Event|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
535212|NCT00676143|B3|Baseline|Total|Total of all reporting groups
535213|NCT00676143|B2|Baseline|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535214|NCT00676143|B1|Baseline|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
535215|NCT00676143|P2|Participant Flow|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535216|NCT00676143|P1|Participant Flow|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
535217|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535218|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535219|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535220|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535221|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535222|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535223|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535224|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535225|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535226|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535227|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535228|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535229|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535230|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535231|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535232|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535233|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535234|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535235|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535236|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535237|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535238|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535239|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535240|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535241|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535242|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535243|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535244|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535245|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535246|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535247|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535248|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535378|NCT00675948|B1|Baseline|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
535249|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535250|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535251|NCT00676143|E2|Reported Event|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
535252|NCT00676143|E1|Reported Event|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
535253|NCT00676130|B3|Baseline|Total|Total of all reporting groups
535254|NCT00676130|B2|Baseline|Placebo|Cephalexin plus placebo
535255|NCT00676130|B1|Baseline|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
535256|NCT00676130|P2|Participant Flow|Placebo|Cephalexin plus placebo
535257|NCT00676130|P1|Participant Flow|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
535258|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
535259|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
535260|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
535261|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
535262|NCT00676130|E2|Reported Event|Placebo|Cephalexin plus placebo
535263|NCT00676130|E1|Reported Event|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
535264|NCT00676091|B3|Baseline|Total|Total of all reporting groups
535265|NCT00676091|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535266|NCT00676091|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535267|NCT00676091|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535268|NCT00676091|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535269|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535270|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535271|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535272|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535273|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535274|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535275|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535276|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535277|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535278|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535279|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535280|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535281|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535282|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535283|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535284|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535285|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535286|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535287|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535288|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535289|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535290|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535291|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535292|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
535293|NCT00676091|E6|Reported Event|Toddler Dose 7vPnC|"7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=64; systematic (solicited) Local Reactions N=67; systematic (solicited) Systemic Events N=86."
535294|NCT00676091|E5|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=81; systematic (solicited) Systemic Events N=84. Total N at Risk=155: 1 participant had no record of safety information during the Toddler dose period and was not included in the Safety population."
535295|NCT00676091|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
535296|NCT00676091|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
535297|NCT00676091|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
535298|NCT00676091|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
535299|NCT00676065|B4|Baseline|Total|Total of all reporting groups
535300|NCT00676065|B3|Baseline|OC-other|Users of oral contraceptives containing other progestogens
535301|NCT00676065|B2|Baseline|OC-LNG|Users of oral contraceptives containing levonorgestrel
535302|NCT00676065|B1|Baseline|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
535303|NCT00676065|P3|Participant Flow|OC-other|Users of oral contraceptives containing other progestogens
535304|NCT00676065|P2|Participant Flow|OC-LNG|Users of oral contraceptives containing levonorgestrel
535305|NCT00676065|P1|Participant Flow|Yasmin|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
535306|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
535307|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
535308|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
535309|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
535310|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
535311|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
535312|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
535313|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
535314|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
535315|NCT00676065|E3|Reported Event|OC-other|Users of oral contraceptives containing other progestogens
535316|NCT00676065|E2|Reported Event|OC-LNG|Users of oral contraceptives containing levonorgestrel
535317|NCT00676065|E1|Reported Event|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
535318|NCT00676052|B7|Baseline|Total|Total of all reporting groups
535319|NCT00676052|B6|Baseline|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
535320|NCT00676052|B5|Baseline|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
535321|NCT00676052|B4|Baseline|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
535322|NCT00676052|B3|Baseline|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
535323|NCT00676052|B2|Baseline|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
535324|NCT00676052|B1|Baseline|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
535348|NCT00676052|O1|Outcome|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
535325|NCT00676052|P6|Participant Flow|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
535326|NCT00676052|P5|Participant Flow|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
535327|NCT00676052|P4|Participant Flow|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
535328|NCT00676052|P3|Participant Flow|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
535329|NCT00676052|P2|Participant Flow|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 micrograms (mcg) administered once daily via a novel dry powder inhaler.
535330|NCT00676052|P1|Participant Flow|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
535331|NCT00676052|O6|Outcome|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
535332|NCT00676052|O5|Outcome|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
535333|NCT00676052|O4|Outcome|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
535334|NCT00676052|O3|Outcome|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
535335|NCT00676052|O2|Outcome|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
535336|NCT00676052|O1|Outcome|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
535337|NCT00676052|O6|Outcome|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
535338|NCT00676052|O5|Outcome|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
535339|NCT00676052|O4|Outcome|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
535340|NCT00676052|O3|Outcome|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
535341|NCT00676052|O2|Outcome|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
535342|NCT00676052|O1|Outcome|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
535343|NCT00676052|O6|Outcome|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
535344|NCT00676052|O5|Outcome|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
535345|NCT00676052|O4|Outcome|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
535346|NCT00676052|O3|Outcome|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
535347|NCT00676052|O2|Outcome|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
535349|NCT00676052|O6|Outcome|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
535350|NCT00676052|O5|Outcome|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
535351|NCT00676052|O4|Outcome|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
535352|NCT00676052|O3|Outcome|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
535353|NCT00676052|O2|Outcome|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
535354|NCT00676052|O1|Outcome|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
535355|NCT00676052|E6|Reported Event|GSK233705B 200 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 200 mcg administered once daily via a novel dry powder inhaler.
535356|NCT00676052|E5|Reported Event|GSK233705B 100 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 100 mcg administered once daily via a novel dry powder inhaler.
535357|NCT00676052|E4|Reported Event|GSK233705B 50 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 50 mcg administered once daily via a novel dry powder inhaler.
535358|NCT00676052|E3|Reported Event|GSK233705B 25 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 25 mcg administered once daily via a novel dry powder inhaler.
535359|NCT00676052|E2|Reported Event|GSK233705B 12.5 mcg|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive GSK233705B 12.5 mcg administered once daily via a novel dry powder inhaler.
535360|NCT00676052|E1|Reported Event|Placebo|Eligible participants completed a two week run-in period during which they received placebo once daily via the novel dry powder inhaler. After run-in period, participants were randomized to receive placebo administered once daily via a novel dry powder inhaler.
535361|NCT00676026|B1|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
535362|NCT00676026|P1|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
535363|NCT00676026|O1|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
535364|NCT00676026|E1|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
535365|NCT00675987|B3|Baseline|Total|Total of all reporting groups
535366|NCT00675987|B2|Baseline|Placebo 1 Tab po QD|Placebo 1 tab po QD
535367|NCT00675987|B1|Baseline|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
535368|NCT00675987|P2|Participant Flow|Placebo 1 Tab po QD|Placebo 1 tab po QD
535369|NCT00675987|P1|Participant Flow|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
535370|NCT00675987|O2|Outcome|Losartan|
535371|NCT00675987|O1|Outcome|Placebo|
535372|NCT00675987|O2|Outcome|Losartan|
535373|NCT00675987|O1|Outcome|Placebo|
535374|NCT00675987|E2|Reported Event|Placebo 1 Tab po QD|Placebo 1 tab po QD
535375|NCT00675987|E1|Reported Event|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
535376|NCT00675948|B3|Baseline|Total|Total of all reporting groups
535377|NCT00675948|B2|Baseline|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
535425|NCT00675792|E1|Reported Event|Sugammadex|4 mg/kg sugammadex
535379|NCT00675948|P2|Participant Flow|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
535380|NCT00675948|P1|Participant Flow|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
535381|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
535382|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
535383|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
535384|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
535385|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
535386|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
535387|NCT00675948|E2|Reported Event|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
535388|NCT00675948|E1|Reported Event|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
535389|NCT00675922|B1|Baseline|Sulfamylon vs Silver Nitrate Solution|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
535390|NCT00675922|P1|Participant Flow|Sulfamylon Solution 5% and Silver Nitrate Soaks|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
535391|NCT00675922|O2|Outcome|Percent Infections: Silver Nitrate Site|Percent of sites that developed infections with Silver Nitrate soaks
535392|NCT00675922|O1|Outcome|Percent Infections:Sulfamylon Site|Percent of sites that developed infections with Sulfamylon soaks
535393|NCT00675922|E1|Reported Event|Sulfamylon Soaks, Silver Nitrate Soaks|Patients receive both treatments and each treated site is compared.
535394|NCT00675909|B4|Baseline|Total|Total of all reporting groups
535395|NCT00675909|B3|Baseline|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
535396|NCT00675909|B2|Baseline|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
535397|NCT00675909|B1|Baseline|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
535398|NCT00675909|P3|Participant Flow|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
535399|NCT00675909|P2|Participant Flow|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
535400|NCT00675909|P1|Participant Flow|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
535401|NCT00675909|O3|Outcome|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
535402|NCT00675909|O2|Outcome|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
535403|NCT00675909|O1|Outcome|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
535404|NCT00675909|E3|Reported Event|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
535405|NCT00675909|E2|Reported Event|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
535406|NCT00675909|E1|Reported Event|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
535407|NCT00675792|B3|Baseline|Total|Total of all reporting groups
535408|NCT00675792|B2|Baseline|Neostigmine|50 µg/kg neostigmine
535409|NCT00675792|B1|Baseline|Sugammadex|4 mg/kg sugammadex
535410|NCT00675792|P2|Participant Flow|Neostigmine|50 µg/kg neostigmine
535411|NCT00675792|P1|Participant Flow|Sugammadex|4 mg/kg sugammadex
535412|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
535413|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
535414|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
535415|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
535416|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
535417|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
535418|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
535419|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
535420|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
535421|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
535422|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
535423|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
535424|NCT00675792|E2|Reported Event|Neostigmine|50 µg/kg neostigmine
535431|NCT00675766|P4|Participant Flow|Group 4|HIV-negative controls 18-40 years old
535432|NCT00675766|P3|Participant Flow|Group 3|HIV-negative controls 50 and older
535433|NCT00675766|P2|Participant Flow|Group 2|HIV-positive adults 18-40 years old
535434|NCT00675766|P1|Participant Flow|Group 1|HIV-positive adults 50 and older
535435|NCT00675766|O4|Outcome|Group 4|HIV-negative controls 18-40 years old
535436|NCT00675766|O3|Outcome|Group 3|HIV-negative controls 50 and older
535437|NCT00675766|O2|Outcome|Group 2|HIV-positive adults 18-40 years old
535438|NCT00675766|O1|Outcome|Group 1|HIV-positive adults 50 and older
535439|NCT00675766|E4|Reported Event|Group 4|HIV-negative controls 18-40 years old
535440|NCT00675766|E3|Reported Event|Group 3|HIV-negative controls 50 and older
535441|NCT00675766|E2|Reported Event|Group 2|HIV-positive adults 18-40 years old
535442|NCT00675766|E1|Reported Event|Group 1|HIV-positive adults 50 and older
535443|NCT00675597|B1|Baseline|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
535444|NCT00675597|P1|Participant Flow|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
535445|NCT00675597|O1|Outcome|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
535446|NCT00675597|E1|Reported Event|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
535447|NCT00675584|B3|Baseline|Total|Total of all reporting groups
535448|NCT00675584|B2|Baseline|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
535449|NCT00675584|B1|Baseline|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
535450|NCT00675584|P2|Participant Flow|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
535451|NCT00675584|P1|Participant Flow|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
535452|NCT00675584|O2|Outcome|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
535453|NCT00675584|O1|Outcome|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
535454|NCT00675584|E2|Reported Event|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
535455|NCT00675584|E1|Reported Event|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
535456|NCT00675558|B4|Baseline|Total|Total of all reporting groups
535457|NCT00675558|B3|Baseline|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535458|NCT00675558|B2|Baseline|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535459|NCT00675558|B1|Baseline|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
535460|NCT00675558|P3|Participant Flow|Super-morbidly Obese (SMO)|"Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.~10 subjects of the original 30 subjects enrolled into this group received a second bariatric procedure. The remaining 20 subjects of the original 30 subjects did not continue on to the second phase (initial bariatric surgery) of the study."
535461|NCT00675558|P2|Participant Flow|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535462|NCT00675558|P1|Participant Flow|Non-Obese (NO)|Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
535463|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535464|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535465|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
535466|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535467|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535468|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
535469|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535470|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535471|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
536212|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
535472|NCT00675558|E3|Reported Event|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535473|NCT00675558|E2|Reported Event|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
535474|NCT00675558|E1|Reported Event|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
535475|NCT00675506|B3|Baseline|Total|Total of all reporting groups
535476|NCT00675506|B2|Baseline|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535477|NCT00675506|B1|Baseline|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535478|NCT00675506|P2|Participant Flow|Placebo|"Participants received treatment with placebo medication.~Placebo : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535479|NCT00675506|P1|Participant Flow|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535480|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535481|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535482|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535483|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
535484|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535485|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535486|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535487|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
535488|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535489|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
535490|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535491|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
535492|NCT00675506|E2|Reported Event|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535493|NCT00675506|E1|Reported Event|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
535494|NCT00675441|B1|Baseline|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
535495|NCT00675441|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
535496|NCT00675441|O1|Outcome|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
535497|NCT00675441|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
535498|NCT00675428|B3|Baseline|Total|Total of all reporting groups
535499|NCT00675428|B2|Baseline|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535500|NCT00675428|B1|Baseline|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535501|NCT00675428|P2|Participant Flow|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535502|NCT00675428|P1|Participant Flow|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535503|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535504|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535505|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535506|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535507|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535508|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535509|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535510|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535511|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535512|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535513|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535514|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535515|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535516|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535517|NCT00675428|E2|Reported Event|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
535518|NCT00675428|E1|Reported Event|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
535519|NCT00675415|B3|Baseline|Total|Total of all reporting groups
535520|NCT00675415|B2|Baseline|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
535521|NCT00675415|B1|Baseline|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
535522|NCT00675415|P2|Participant Flow|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
535523|NCT00675415|P1|Participant Flow|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
535524|NCT00675415|O2|Outcome|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
535525|NCT00675415|O1|Outcome|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
535526|NCT00675415|O2|Outcome|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
535527|NCT00675415|O1|Outcome|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
535528|NCT00675415|O2|Outcome|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
535529|NCT00675415|O1|Outcome|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
535642|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535530|NCT00675415|O2|Outcome|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
535531|NCT00675415|O1|Outcome|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
535532|NCT00675415|E2|Reported Event|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
535533|NCT00675415|E1|Reported Event|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
535534|NCT00675259|B1|Baseline|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
535535|NCT00675259|P1|Participant Flow|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
535536|NCT00675259|O3|Outcome|Patients With Hormone-responsive BC|Hormone-responsive breast cancer (BC)
535537|NCT00675259|O2|Outcome|Patients With pCR|Pathologic complete response (pCR)
535538|NCT00675259|O1|Outcome|Patients With TNBC|Women with triple negative breast cancer (TNBC)
535539|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
535540|NCT00675259|O1|Outcome|Adjuvant Bevacizumab|Patients received 6 months of adjuvant bevacizumab therapy
535541|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
535542|NCT00675259|E1|Reported Event|Toxicities During Neoadjuvant Chemotherapy|
535543|NCT00675103|B1|Baseline|Pegloticase 8 mg Every 2 Wks|
535544|NCT00675103|P1|Participant Flow|Pegloticase 8 mg Every 2 Wks|
535545|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
535546|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
535547|NCT00675103|E1|Reported Event|Pegloticase 8 mg Every 2 Wks|
535548|NCT00674986|B3|Baseline|Total|Total of all reporting groups
535549|NCT00674986|B2|Baseline|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535550|NCT00674986|B1|Baseline|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535551|NCT00674986|P2|Participant Flow|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535552|NCT00674986|P1|Participant Flow|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535553|NCT00674986|O1|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535554|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535555|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535556|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535557|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535558|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535559|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535560|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535561|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535562|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535563|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535564|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535565|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535566|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535567|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535568|NCT00674986|E2|Reported Event|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
535569|NCT00674986|E1|Reported Event|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
535570|NCT00674973|B3|Baseline|Total|Total of all reporting groups
535571|NCT00674973|B2|Baseline|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535572|NCT00674973|B1|Baseline|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535763|NCT00674700|B2|Baseline|500 IR|500 IR house dust mites allergen extract tablet
535764|NCT00674700|B1|Baseline|300 IR|300 IR house dust mites allergen extract tablet
535573|NCT00674973|P2|Participant Flow|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535574|NCT00674973|P1|Participant Flow|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535575|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535576|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535577|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535578|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535579|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535580|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535581|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535582|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535583|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535584|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535585|NCT00674973|E2|Reported Event|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
535586|NCT00674973|E1|Reported Event|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
535587|NCT00674817|B1|Baseline|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
535588|NCT00674817|P1|Participant Flow|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
535589|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535590|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535765|NCT00674700|P3|Participant Flow|Placebo|Placebo tablet
535591|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535592|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535593|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535594|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535595|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535596|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535597|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535598|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535599|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535600|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535601|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535602|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535603|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535604|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535605|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535606|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535607|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535608|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535609|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535610|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535611|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535612|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535613|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535614|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535615|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535766|NCT00674700|P2|Participant Flow|500 IR|500 IR house dust mites allergen extract tablet
535767|NCT00674700|P1|Participant Flow|300 IR|300 IR house dust mites allergen extract tablet
535616|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535617|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535618|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535619|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535620|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535621|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535622|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535623|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535624|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535625|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535626|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535627|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535628|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535629|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535630|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535631|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535632|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535633|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535634|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535635|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535636|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535637|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535638|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535639|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535640|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535641|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535643|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535644|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535645|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535646|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535647|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535648|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535649|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535650|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535651|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535652|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535653|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535654|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535655|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535656|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535657|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535658|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535659|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535660|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535661|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535662|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535663|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535664|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535665|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535666|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535667|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535668|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535669|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535670|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535671|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535672|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535673|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535674|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535675|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535676|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535677|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535678|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535679|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535680|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535681|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535682|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535683|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535684|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535685|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535686|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535687|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535688|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535689|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535690|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535691|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535692|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535693|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535768|NCT00674700|O3|Outcome|Placebo|Placebo tablet
535769|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
535770|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
535694|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535695|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535696|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535697|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535698|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535699|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535700|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535701|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535702|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535703|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535704|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535705|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535706|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535707|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535708|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535709|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535710|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535711|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535712|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535713|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535714|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535715|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535716|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535717|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535718|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535719|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535720|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535721|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535722|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535723|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535724|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535725|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535726|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535727|NCT00674817|E6|Reported Event|1200 Microgrammes of GSK961081 and Placebo|1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535728|NCT00674817|E5|Reported Event|400 Microgrammes of GSK961081 and Placebo|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
535729|NCT00674817|E4|Reported Event|1200 Microgrammes of GSK961081 and Ipratropium Bromide|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535730|NCT00674817|E3|Reported Event|400 Microgrammes GSK961081 and Ipratropium Bromide|400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
535731|NCT00674817|E2|Reported Event|1200 Microgrammes GSK961081 and Salbutamol|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535732|NCT00674817|E1|Reported Event|400 Microgrammes GSK961081 and Salbutamol|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
535733|NCT00674765|B3|Baseline|Total|Total of all reporting groups
535734|NCT00674765|B2|Baseline|Placebo|"Placebo~Placebo: 400 mg/day"
535735|NCT00674765|B1|Baseline|Seroquel|"Seroquel~Seroquel: 400 mg/day"
535736|NCT00674765|P2|Participant Flow|Placebo|"Placebo~Placebo: 400 mg/day"
535737|NCT00674765|P1|Participant Flow|Seroquel|"Seroquel~Seroquel: 400 mg/day"
535738|NCT00674765|O2|Outcome|Placebo Sugar Pill|"Placebo~Placebo: 400 mg/day"
535739|NCT00674765|O1|Outcome|Seroquel (Quetiapine)|"Seroquel (quetiapine)~Seroquel: 400 mg/day"
535740|NCT00674765|E2|Reported Event|Placebo|"Placebo~Placebo: 400 mg/day"
535741|NCT00674765|E1|Reported Event|Seroquel|"Seroquel~Seroquel: 400 mg/day"
535742|NCT00674739|B4|Baseline|Total|Total of all reporting groups
535743|NCT00674739|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
535744|NCT00674739|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
535745|NCT00674739|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
535746|NCT00674739|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
535747|NCT00674739|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
535748|NCT00674739|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
535749|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
535750|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
535751|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
535752|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
535753|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
535754|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
535755|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
535756|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
535757|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
535758|NCT00674739|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
535759|NCT00674739|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
535760|NCT00674739|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
535761|NCT00674700|B4|Baseline|Total|Total of all reporting groups
535762|NCT00674700|B3|Baseline|Placebo|Placebo tablet
535772|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
535773|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
535774|NCT00674700|E3|Reported Event|Placebo|Placebo tablet
535775|NCT00674700|E2|Reported Event|500 IR|500 IR house dust mites allergen extract tablet
535776|NCT00674700|E1|Reported Event|300 IR|300 IR house dust mites allergen extract tablet
535777|NCT00674661|B3|Baseline|Total|Total of all reporting groups
535778|NCT00674661|B2|Baseline|Control Group|riboflavin opthalmic solution without UVA irradiation
535779|NCT00674661|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
535780|NCT00674661|P2|Participant Flow|Control Group|riboflavin opthalmic solution without UVA irradiation
535781|NCT00674661|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
535782|NCT00674661|O2|Outcome|Control Group|riboflavin opthalmic solution without UVA irradiation
535783|NCT00674661|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
535784|NCT00674661|E2|Reported Event|Control Group|riboflavin opthalmic solution without UVA irradiation
535785|NCT00674661|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
535786|NCT00674622|B4|Baseline|Total|Total of all reporting groups
535787|NCT00674622|B3|Baseline|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535788|NCT00674622|B2|Baseline|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535789|NCT00674622|B1|Baseline|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535790|NCT00674622|P3|Participant Flow|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535791|NCT00674622|P2|Participant Flow|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535792|NCT00674622|P1|Participant Flow|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535793|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535794|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535795|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535796|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535797|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535798|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535799|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535800|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535801|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535802|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535803|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535804|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535805|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535806|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535807|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535808|NCT00674622|E3|Reported Event|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
535809|NCT00674622|E2|Reported Event|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
535810|NCT00674622|E1|Reported Event|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
535811|NCT00674609|B4|Baseline|Total|Total of all reporting groups
535812|NCT00674609|B3|Baseline|Placebo|Each 100 uL actuation contained colourant and excipients
535813|NCT00674609|B2|Baseline|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
535814|NCT00674609|B1|Baseline|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
535815|NCT00674609|P3|Participant Flow|Placebo|Each 100 uL actuation contained colourant and excipients
535816|NCT00674609|P2|Participant Flow|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
535817|NCT00674609|P1|Participant Flow|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
535818|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535819|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535820|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535821|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535822|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535823|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
536034|NCT00674115|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
535824|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535825|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535826|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535827|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535828|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535829|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535830|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535831|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535832|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535833|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535834|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535835|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535836|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535837|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535838|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535839|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535840|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535841|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535842|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
535843|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
535844|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
535845|NCT00674609|E3|Reported Event|Placebo|Maximum number of daily sprays was 48
535846|NCT00674609|E2|Reported Event|THC Alone|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC
535847|NCT00674609|E1|Reported Event|Sativex|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD
535848|NCT00674583|B3|Baseline|Total|Total of all reporting groups
535849|NCT00674583|B2|Baseline|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535850|NCT00674583|B1|Baseline|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535851|NCT00674583|P2|Participant Flow|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535852|NCT00674583|P1|Participant Flow|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535853|NCT00674583|O2|Outcome|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535854|NCT00674583|O1|Outcome|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535855|NCT00674583|O2|Outcome|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535856|NCT00674583|O1|Outcome|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535857|NCT00674583|O2|Outcome|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535858|NCT00674583|O1|Outcome|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535859|NCT00674583|O2|Outcome|Menjugate Group (≥ 6 Years)|Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535860|NCT00674583|O1|Outcome|Nimenrix Group (≥ 6 Years)|Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535861|NCT00674583|O2|Outcome|Menjugate Group (< 6 Years)|Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535862|NCT00674583|O1|Outcome|Nimenrix Group (< 6 Years)|Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535863|NCT00674583|O2|Outcome|Menjugate Group (≥ 6 Years)|Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535864|NCT00674583|O1|Outcome|Nimenrix Group (≥ 6 Years)|Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535865|NCT00674583|O2|Outcome|Menjugate Group (< 6 Years)|Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535866|NCT00674583|O1|Outcome|Nimenrix Group (< 6 Years)|Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535867|NCT00674583|O2|Outcome|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535868|NCT00674583|O1|Outcome|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535869|NCT00674583|O2|Outcome|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535870|NCT00674583|O1|Outcome|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535871|NCT00674583|O2|Outcome|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535872|NCT00674583|O1|Outcome|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535873|NCT00674583|E2|Reported Event|Menjugate Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
535874|NCT00674583|E1|Reported Event|Nimenrix Group|Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
535875|NCT00674492|B1|Baseline|Group 1|patients who initiated antiviral treatment for hepatitis C
535876|NCT00674492|P1|Participant Flow|Group 1|patients who initiated antiviral treatment for hepatitis C
535877|NCT00674492|O1|Outcome|Group 1|patients who initiated antiviral treatment for hepatitis C
535878|NCT00674492|E1|Reported Event|Group 1|patients who initiated antiviral treatment for hepatitis C
535879|NCT00674466|B4|Baseline|Total|Total of all reporting groups
535880|NCT00674466|B3|Baseline|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
535881|NCT00674466|B2|Baseline|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
535882|NCT00674466|B1|Baseline|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
535883|NCT00674466|P3|Participant Flow|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
535884|NCT00674466|P2|Participant Flow|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
535885|NCT00674466|P1|Participant Flow|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
535886|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
535887|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
535888|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
535889|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
536035|NCT00674115|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
535890|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
535891|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
535892|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
535893|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
535894|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
535895|NCT00674466|E3|Reported Event|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
535896|NCT00674466|E2|Reported Event|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
535897|NCT00674466|E1|Reported Event|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
535898|NCT00674362|B3|Baseline|Total|Total of all reporting groups
535899|NCT00674362|B2|Baseline|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535900|NCT00674362|B1|Baseline|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535901|NCT00674362|P2|Participant Flow|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535902|NCT00674362|P1|Participant Flow|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535903|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535904|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535905|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535906|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535907|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535908|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535909|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535910|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535911|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535912|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535913|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535914|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535915|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535916|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535917|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535918|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535919|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535920|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535921|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535922|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535923|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535924|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
536036|NCT00674115|E5|Reported Event|Prilosec (1-Day Dosing)|
536037|NCT00674115|E4|Reported Event|Zegerid (1-Day Dosing)|
535925|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535926|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535927|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535928|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535929|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535930|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535931|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535932|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535933|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535934|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535935|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535936|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535937|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535938|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535939|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535940|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535941|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535942|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535943|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535944|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535945|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535946|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535947|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535948|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535949|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535950|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535951|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535952|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535953|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535954|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535955|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535956|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535957|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
536213|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
535958|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535959|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535960|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535961|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535962|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535963|NCT00674362|E3|Reported Event|Open Label Phase|At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
535964|NCT00674362|E2|Reported Event|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
535965|NCT00674362|E1|Reported Event|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
535966|NCT00674323|B4|Baseline|Total|Total of all reporting groups
535967|NCT00674323|B3|Baseline|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535968|NCT00674323|B2|Baseline|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535969|NCT00674323|B1|Baseline|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535970|NCT00674323|P3|Participant Flow|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535971|NCT00674323|P2|Participant Flow|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535972|NCT00674323|P1|Participant Flow|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535973|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
536033|NCT00674115|P1|Participant Flow|Zegerid, Prilosec, Sodium Bicarbonate|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
536214|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
535974|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535975|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535976|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535977|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535978|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535979|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535980|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535981|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535982|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535983|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535984|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
535985|NCT00674323|E3|Reported Event|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
535986|NCT00674323|E2|Reported Event|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
535987|NCT00674323|E1|Reported Event|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
535988|NCT00674297|B1|Baseline|Fluvastatin|"All patients will take Fluvastatin 40 mg daily for 3 months.~Fluvastatin: Fluvastatin 40 mg daily for 3 months"
535989|NCT00674297|P4|Participant Flow|SLE/aPL|Persistent aPL positivity with SLE but no APS.
535990|NCT00674297|P3|Participant Flow|Primary aPL|Persistant aPL positivity without SLE or APS.
535991|NCT00674297|P2|Participant Flow|SLE/APS|SLE with APS
535992|NCT00674297|P1|Participant Flow|PAPS|Primary APS
535993|NCT00674297|O4|Outcome|SLE/aPL|Persistent aPL positivity with SLE but no APS.
535994|NCT00674297|O3|Outcome|Primary aPL|Persistant aPL positivity without SLE or APS.
535995|NCT00674297|O2|Outcome|SLE/APS|SLE with APS
535996|NCT00674297|O1|Outcome|PAPS|Primary APS
535997|NCT00674297|O4|Outcome|SLE/aPL|Persistent aPL positivity with SLE but no APS.
535998|NCT00674297|O3|Outcome|Primary aPL|Persistant aPL positivity without SLE or APS.
535999|NCT00674297|O2|Outcome|SLE/APS|SLE with APS
536000|NCT00674297|O1|Outcome|PAPS|Primary APS
536001|NCT00674297|O4|Outcome|SLE/aPL|Persistent aPL positivity with SLE but no APS.
536002|NCT00674297|O3|Outcome|Primary aPL|Persistant aPL positivity without SLE or APS.
536003|NCT00674297|O2|Outcome|SLE/APS|SLE with APS
536004|NCT00674297|O1|Outcome|PAPS|Primary APS
536005|NCT00674297|E1|Reported Event|aPL Positive Patients|Patients with aPL positivity
536006|NCT00674206|B1|Baseline|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
536007|NCT00674206|P1|Participant Flow|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
536008|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
536009|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
536010|NCT00674206|E1|Reported Event|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
536011|NCT00674154|B3|Baseline|Total|Total of all reporting groups
536012|NCT00674154|B2|Baseline|Placebo|Placebo, two tablets daily in 52 weeks.
536013|NCT00674154|B1|Baseline|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
536014|NCT00674154|P2|Participant Flow|Placebo|Placebo, two tablets daily in 52 weeks.
536015|NCT00674154|P1|Participant Flow|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
536016|NCT00674154|O2|Outcome|Placebo|Placebo, two tablets daily in 52 weeks.
536017|NCT00674154|O1|Outcome|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
536018|NCT00674154|E2|Reported Event|Placebo|Placebo, two tablets daily in 52 weeks.
536019|NCT00674154|E1|Reported Event|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
536020|NCT00674128|B3|Baseline|Total|Total of all reporting groups
536021|NCT00674128|B2|Baseline|Suture|Polyglactin 910 suture.
536022|NCT00674128|B1|Baseline|Adhesive|Cyanoacrylate tissue adhesive.
536023|NCT00674128|P2|Participant Flow|Suture|Polyglactin 910 suture.
536024|NCT00674128|P1|Participant Flow|Adhesive|Cyanoacrylate tissue adhesive.
536025|NCT00674128|O2|Outcome|Suture|Polyglactin 910 suture.
536026|NCT00674128|O1|Outcome|Adhesive|Cyanoacrylate tissue adhesive.
536027|NCT00674128|E2|Reported Event|Suture|Polyglactin 910 suture
536028|NCT00674128|E1|Reported Event|Adhesive|Cyanoacrylate tissue adhesive.
536029|NCT00674115|B1|Baseline|Entire Study Population|
536030|NCT00674115|P4|Participant Flow|Prilosec, Zegerid|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period)
536031|NCT00674115|P3|Participant Flow|Zegerid, Prilosec|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
536032|NCT00674115|P2|Participant Flow|Prilosec, Zegerid, Sodium Bicarbonate|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
536089|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
536038|NCT00674115|E3|Reported Event|Sodium Bicarbonate (1-Day Dosing)|Following completion of the 1-day dosing 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate 1680 mg.
536039|NCT00674115|E2|Reported Event|Prilosec (7-Day Dosing)|
536040|NCT00674115|E1|Reported Event|Zegerid (7-Day Dosing)|
536041|NCT00673959|B1|Baseline|Overall Study|
536042|NCT00673959|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
536043|NCT00673959|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received Lubricant Drops first, then received Optive Drops
536044|NCT00673959|O2|Outcome|Optive Lubricant Eye Drop|
536045|NCT00673959|O1|Outcome|Lubricant Eye Drop FID 111421|
536046|NCT00673959|E2|Reported Event|Optive Lubricant Eye Drop|
536047|NCT00673959|E1|Reported Event|Lubricant Eye Drop FID 111421|
536048|NCT00673933|B1|Baseline|Visonac and Vehicle Cream With PDT|Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.
536049|NCT00673933|P1|Participant Flow|Visonac Cream With PDT and Vehicle and PDT|Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
536050|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536051|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536052|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536053|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536054|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536055|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536056|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536057|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536058|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536059|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536060|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536061|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536062|NCT00673933|E2|Reported Event|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536063|NCT00673933|E1|Reported Event|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
536064|NCT00673881|B1|Baseline|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
536065|NCT00673881|P1|Participant Flow|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
536066|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
536067|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
536068|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
536069|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
536070|NCT00673881|E1|Reported Event|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
536071|NCT00673855|B1|Baseline|Overall Study|
536072|NCT00673855|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
536073|NCT00673855|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received lubricant Drops first, then received Optive Drops
536074|NCT00673855|O2|Outcome|Lubricant Eye Drops|Lubricant Eye Drops
536075|NCT00673855|O1|Outcome|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
536076|NCT00673855|E2|Reported Event|Lubricant Eye Drops|Lubricant Eye Drops
536077|NCT00673855|E1|Reported Event|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
536078|NCT00673816|B1|Baseline|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
536079|NCT00673816|P1|Participant Flow|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
536080|NCT00673816|O2|Outcome|Right Eye|
536081|NCT00673816|O1|Outcome|Left Eye|
536082|NCT00673816|O2|Outcome|Right Eye|
536083|NCT00673816|O1|Outcome|Left Eye|
536084|NCT00673816|E1|Reported Event|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
536085|NCT00673764|B1|Baseline|Overall Study|Overall Study
536086|NCT00673764|P2|Participant Flow|Optive, Then Systane Ultra|Optive Lubricant Eye Drops first, then cross-over to Systane Ultra.
536087|NCT00673764|P1|Participant Flow|Systane Ultra, Then Optive|Systane Ultra Lubricant Eye Drops first, then cross-over to Optive.
536088|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
536091|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
536092|NCT00673764|E2|Reported Event|Optive|Optive Lubricant Eye Drops
536093|NCT00673764|E1|Reported Event|Systane Ultra|Systane Ultra Lubricant Eye Drops.
536094|NCT00673738|B1|Baseline|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
536095|NCT00673738|P1|Participant Flow|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
536096|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
536097|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
536098|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
536099|NCT00673738|E1|Reported Event|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
536100|NCT00673712|B3|Baseline|Total|Total of all reporting groups
536101|NCT00673712|B2|Baseline|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
536102|NCT00673712|B1|Baseline|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
536103|NCT00673712|P2|Participant Flow|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
536104|NCT00673712|P1|Participant Flow|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
536105|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
536106|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
536107|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
536108|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
536109|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
536110|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
536111|NCT00673712|E2|Reported Event|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
536112|NCT00673712|E1|Reported Event|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
536113|NCT00673673|B1|Baseline|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
536114|NCT00673673|P1|Participant Flow|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
536115|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
536116|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
536117|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
536215|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536216|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536118|NCT00673673|E1|Reported Event|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
536119|NCT00673660|B1|Baseline|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536120|NCT00673660|P1|Participant Flow|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536121|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536122|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536123|NCT00673660|O2|Outcome|Non-compliant With Statin Treatment|Participants with dyslipidemia who were non-compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536124|NCT00673660|O1|Outcome|Compliant With Statin Treatment|Participants with dyslipidemia who were compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536125|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536126|NCT00673660|E4|Reported Event|Statins Visit 5|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536127|NCT00673660|E3|Reported Event|Statins at Visit 4|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536128|NCT00673660|E2|Reported Event|Statins at Visit 3|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536129|NCT00673660|E1|Reported Event|Statins at Visit 2|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
536130|NCT00673595|B3|Baseline|Total|Total of all reporting groups
536131|NCT00673595|B2|Baseline|Placebo|Participants on this arm will receive placebo tablets for 15 days.
536132|NCT00673595|B1|Baseline|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
536133|NCT00673595|P2|Participant Flow|Placebo|Participants on this arm will receive placebo tablets for 15 days.
536134|NCT00673595|P1|Participant Flow|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
536135|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
536136|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
536137|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
536138|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
536139|NCT00673595|E2|Reported Event|Placebo|Participants on this arm will receive placebo tablets for 15 days.
536140|NCT00673595|E1|Reported Event|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
536141|NCT00673465|B1|Baseline|All Treated Participants|All participants received SCH 497079 for 4 weeks, placebo for 4 weeks, and metformin for 4 weeks during one of three parts of the study.
536142|NCT00673465|P12|Participant Flow|Part 2/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks(Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
536143|NCT00673465|P11|Participant Flow|Part 2/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
536144|NCT00673465|P10|Participant Flow|Part 2/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
536145|NCT00673465|P9|Participant Flow|Part 2/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
536146|NCT00673465|P8|Participant Flow|Part 2/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
536147|NCT00673465|P7|Participant Flow|Part 2/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
536148|NCT00673465|P6|Participant Flow|Part 1/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
536149|NCT00673465|P5|Participant Flow|Part 1/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
536150|NCT00673465|P4|Participant Flow|Part 1/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
536151|NCT00673465|P3|Participant Flow|Part 1/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2)followed by placebo daily for 4 weeks (Period 3).
536217|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536218|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536152|NCT00673465|P2|Participant Flow|Part 1/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2)followed by SCH 497079 daily for 4 weeks (Period 3).
536153|NCT00673465|P1|Participant Flow|Part 1/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
536154|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536155|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536156|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536157|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536158|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536159|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536160|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536161|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536162|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536163|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536164|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536165|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536166|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536167|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536168|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536169|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536170|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536171|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536172|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536173|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536174|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536175|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536176|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536177|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536178|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536179|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536180|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536181|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536182|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536183|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536184|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536185|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536186|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536187|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536188|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536189|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536190|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536191|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536192|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536193|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
536194|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
536195|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536196|NCT00673465|E3|Reported Event|Metformin|Participants received metformin daily for 4 weeks during one of 3 parts of the study.
536197|NCT00673465|E2|Reported Event|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
536198|NCT00673465|E1|Reported Event|Placebo|Participants received placebo daily for 4 weeks during one of 3 parts of the study.
536199|NCT00673452|B3|Baseline|Total|Total of all reporting groups
536200|NCT00673452|B2|Baseline|Placebo|oral, daily, 12 weeks
536201|NCT00673452|B1|Baseline|Duloxetine|60-120 mg, oral, daily, 12 weeks
536202|NCT00673452|P2|Participant Flow|Placebo|oral, daily, 12 weeks
536203|NCT00673452|P1|Participant Flow|Duloxetine|60-120 mg, oral, daily, 12 weeks
536204|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536205|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536219|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536220|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536221|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536222|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536223|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536224|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536225|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536226|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536227|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536228|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536229|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536230|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536231|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536232|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
536233|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
536234|NCT00673452|E2|Reported Event|Placebo|oral, daily, 12 weeks
536235|NCT00673452|E1|Reported Event|Duloxetine|60-120 mg, oral, daily, 12 weeks
536236|NCT00673439|B1|Baseline|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
536237|NCT00673439|P1|Participant Flow|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
536238|NCT00673439|O1|Outcome|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg|
536239|NCT00673439|E1|Reported Event|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
536240|NCT00673400|B1|Baseline|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
536241|NCT00673400|P1|Participant Flow|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
536242|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
536243|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
536244|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
536245|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
536246|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
536247|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
536248|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
536249|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
536250|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
536251|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
536252|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
536253|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
536254|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured within one month before surgery
536255|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
536256|NCT00673400|E1|Reported Event|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
536257|NCT00673387|B9|Baseline|Total|Total of all reporting groups
536258|NCT00673387|B8|Baseline|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536259|NCT00673387|B7|Baseline|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536260|NCT00673387|B6|Baseline|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536261|NCT00673387|B5|Baseline|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536262|NCT00673387|B4|Baseline|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536263|NCT00673387|B3|Baseline|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536264|NCT00673387|B2|Baseline|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536265|NCT00673387|B1|Baseline|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536266|NCT00673387|P8|Participant Flow|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536267|NCT00673387|P7|Participant Flow|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536268|NCT00673387|P6|Participant Flow|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536269|NCT00673387|P5|Participant Flow|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536270|NCT00673387|P4|Participant Flow|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536271|NCT00673387|P3|Participant Flow|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536272|NCT00673387|P2|Participant Flow|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536273|NCT00673387|P1|Participant Flow|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536274|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536275|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536276|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536277|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536278|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536279|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536280|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536281|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536282|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536283|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536284|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536285|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536286|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536287|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536288|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536289|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536290|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536291|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536292|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536293|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536294|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536295|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536404|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536512|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536296|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536297|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536298|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536299|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536300|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536301|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536302|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536303|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536304|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536305|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536306|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536307|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536308|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536309|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536310|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536311|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536312|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536313|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536314|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536315|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536316|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536317|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536318|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536319|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536320|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536321|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536513|NCT00673231|O1|Outcome|Placebo|Placebo
536579|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
536322|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536323|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536324|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536325|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536326|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536327|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536328|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536329|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536330|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536331|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536332|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536333|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536334|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536335|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536336|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536337|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536338|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536339|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536340|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536341|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536342|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536343|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536344|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536345|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536346|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536347|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536348|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536349|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536350|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536351|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536352|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536353|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536354|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536355|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536356|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536357|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536358|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536359|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536360|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536361|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536362|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536363|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536364|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536365|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536366|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536367|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536368|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536369|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536370|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536371|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536372|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536373|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536374|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536375|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536376|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536377|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536378|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536379|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536380|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536381|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536382|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536383|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536384|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536385|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536386|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536387|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536388|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536389|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536390|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536391|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536392|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536393|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536394|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536395|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536396|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536397|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536398|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536399|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536400|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536401|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536402|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536403|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536405|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536406|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536407|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536408|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536409|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536410|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536411|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536412|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536413|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536414|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536415|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536416|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536417|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536418|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536419|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536420|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536421|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536422|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536423|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536424|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536425|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536426|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536427|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536428|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536429|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536430|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536457|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536431|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536432|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536433|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536434|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536435|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536436|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536437|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536438|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536439|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536440|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536441|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536442|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536443|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536444|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536445|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536446|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536447|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536448|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536449|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536450|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536451|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536452|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536453|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536454|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536455|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536456|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536458|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536459|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536460|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536461|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536462|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536463|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536464|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536465|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536466|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536467|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536468|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536469|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536470|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536471|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536472|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536473|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536474|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536475|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
536476|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536477|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536478|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536479|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536480|NCT00673387|E8|Reported Event|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536481|NCT00673387|E7|Reported Event|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536482|NCT00673387|E6|Reported Event|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536483|NCT00673387|E5|Reported Event|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
536484|NCT00673387|E4|Reported Event|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
536485|NCT00673387|E3|Reported Event|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
536486|NCT00673387|E2|Reported Event|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
536487|NCT00673387|E1|Reported Event|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
536488|NCT00673361|B1|Baseline|"Chemo-Switch Regimen"|
536489|NCT00673361|P1|Participant Flow|"Chemo-Switch Regimen"|
536490|NCT00673361|O1|Outcome|Terminated Studybefore Accrual Goal|
536491|NCT00673361|E1|Reported Event|"Chemo-Switch Regimen"|
536492|NCT00673257|B1|Baseline|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
536493|NCT00673257|P1|Participant Flow|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
536494|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
536495|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
536496|NCT00673257|E1|Reported Event|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
536497|NCT00673231|B5|Baseline|Total|Total of all reporting groups
536498|NCT00673231|B4|Baseline|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536499|NCT00673231|B3|Baseline|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536500|NCT00673231|B2|Baseline|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536501|NCT00673231|B1|Baseline|Placebo|Placebo
536502|NCT00673231|P4|Participant Flow|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536503|NCT00673231|P3|Participant Flow|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536504|NCT00673231|P2|Participant Flow|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536505|NCT00673231|P1|Participant Flow|Placebo|Placebo
536506|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536507|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536508|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536509|NCT00673231|O1|Outcome|Placebo|Placebo
536510|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536511|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536514|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536515|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536516|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536517|NCT00673231|O1|Outcome|Placebo|Placebo
536518|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536519|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536520|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536521|NCT00673231|O1|Outcome|Placebo|Placebo
536522|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536523|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536524|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536525|NCT00673231|O1|Outcome|Placebo|Placebo
536526|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536527|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536528|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536529|NCT00673231|O1|Outcome|Placebo|Placebo
536530|NCT00673231|E4|Reported Event|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
536531|NCT00673231|E3|Reported Event|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
536532|NCT00673231|E2|Reported Event|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
536533|NCT00673231|E1|Reported Event|Placebo|Placebo
536534|NCT00673179|B3|Baseline|Total|Total of all reporting groups
536535|NCT00673179|B2|Baseline|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
536536|NCT00673179|B1|Baseline|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
536537|NCT00673179|P2|Participant Flow|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
536538|NCT00673179|P1|Participant Flow|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
536539|NCT00673179|O2|Outcome|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
536540|NCT00673179|O1|Outcome|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
536541|NCT00673179|E2|Reported Event|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days
536542|NCT00673179|E1|Reported Event|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
536575|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
536576|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
536577|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
536578|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
536543|NCT00673153|B1|Baseline|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536544|NCT00673153|P1|Participant Flow|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536545|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536546|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536547|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536548|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536549|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536550|NCT00673153|E1|Reported Event|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
536551|NCT00673127|B1|Baseline|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
536552|NCT00673127|P1|Participant Flow|KHAD|KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC
536553|NCT00673127|O1|Outcome|KHAD|KHAD: ketoconazole, hydrocortisone and dutasteride for CRPC
536554|NCT00673127|O1|Outcome|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
536555|NCT00673127|E1|Reported Event|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
536556|NCT00673114|B1|Baseline|Transplant Recipients|single arm study
536557|NCT00673114|P1|Participant Flow|Transplant Recipients|Transplant Recipients
536558|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536559|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536560|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536561|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536562|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536563|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536564|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536565|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
536566|NCT00673114|E1|Reported Event|Transplant Recipients|single arm study
536567|NCT00673075|B3|Baseline|Total|Total of all reporting groups
536568|NCT00673075|B2|Baseline|Carvedilol|Encapsulated Carvedilol
536569|NCT00673075|B1|Baseline|Nebivolol|Encapsulated Nebivolol
536570|NCT00673075|P2|Participant Flow|Carvedilol|Encapsulated Carvedilol
536571|NCT00673075|P1|Participant Flow|Nebivolol|Encapsulated Nebivolol
536572|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
536573|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
536574|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
536580|NCT00673075|E4|Reported Event|Carvedilol Down-Titration|Encapsulated Carvedilol Down-Titration Period
536581|NCT00673075|E3|Reported Event|Nebivolol Down-Titration|Encapsulated Nebivolol Down-Titration Period
536582|NCT00673075|E2|Reported Event|Carvedilol Combined Up-Titration and Stable-dose|Encapsulated Carvedilol Combined Up-Titration and Stable-Dose Periods
536583|NCT00673075|E1|Reported Event|Nebivolol Combined Up-Titration and Stable-dose|Encapsulated Nebivolol Combined Up-Titration and Stable-Dose Periods
536584|NCT00673049|B3|Baseline|Total|Total of all reporting groups
536585|NCT00673049|B2|Baseline|Erlotinib (as Randomized)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
536586|NCT00673049|B1|Baseline|Figitumumab + Erlotinib (as Randomized)|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
536587|NCT00673049|P4|Participant Flow|Erlotinib, Then Figitumumab|Figitumumab 20 mg/kg was given as a single-agent therapy to participants who had disease progression on erlotinib alone. Figitumumab was administered in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
536588|NCT00673049|P3|Participant Flow|Randomized to Figi + Erlo Arm But Treated Only With Erlo|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536589|NCT00673049|P2|Participant Flow|Erlotinib (Randomized to and Treated With)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536590|NCT00673049|P1|Participant Flow|Figitumumab + Erlotinib (Randomized to and Treated With)|Figitumumab ( [CP-751,871], figi) was given in combination with erlotinib (erlo) in 3-week cycles. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 milligram (mg) daily at least 1 hour before or 2 hours after the ingestion of food.
536591|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536592|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536593|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536594|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536595|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536596|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536597|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
536598|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
536599|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
536600|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
536601|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536602|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536603|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536604|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536605|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536606|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536607|NCT00673049|E3|Reported Event|Erlotinib, Then Figitumumab|Figitumumab (20 mg/kg) was given as a single agent after participants had disease progression on erlotinib alone. Figitumumab was given in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
536608|NCT00673049|E2|Reported Event|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536609|NCT00673049|E1|Reported Event|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycle. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every three weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
536610|NCT00672984|B4|Baseline|Total|Total of all reporting groups
536611|NCT00672984|B3|Baseline|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
536612|NCT00672984|B2|Baseline|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
536613|NCT00672984|B1|Baseline|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
536614|NCT00672984|P3|Participant Flow|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
536615|NCT00672984|P2|Participant Flow|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
536616|NCT00672984|P1|Participant Flow|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
536617|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536618|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
536619|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536620|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
536621|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536622|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
536623|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536624|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
536625|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536626|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
536627|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536628|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
536629|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536630|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536631|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536632|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
536633|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536634|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536635|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536636|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
536637|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536638|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536639|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536640|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
536641|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536642|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536643|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536644|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
536645|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536646|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536647|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536648|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
536649|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536650|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536651|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536652|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
536653|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536654|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536655|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536656|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
536657|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
536658|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
536659|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
536660|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
536661|NCT00672984|E3|Reported Event|Placebo|
536662|NCT00672984|E2|Reported Event|Moxifloxacin|Avelox, positive control
536663|NCT00672984|E1|Reported Event|Guanfacine|Immediate-release Guanfacine HCl
536664|NCT00672958|B3|Baseline|Total|Total of all reporting groups
536665|NCT00672958|B2|Baseline|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536666|NCT00672958|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536667|NCT00672958|P2|Participant Flow|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536668|NCT00672958|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536669|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536670|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536671|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536672|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536673|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536674|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536675|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536676|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536677|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536678|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536679|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536680|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536681|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536682|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536683|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536684|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536685|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536686|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536687|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536688|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536689|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536690|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536691|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536692|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536693|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536694|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536695|NCT00672958|E2|Reported Event|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
536696|NCT00672958|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
536697|NCT00672932|B3|Baseline|Total|Total of all reporting groups
536698|NCT00672932|B2|Baseline|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
536699|NCT00672932|B1|Baseline|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
536700|NCT00672932|P2|Participant Flow|No Augmented Treatment Then Optional Rollover|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. After 12 weeks, subjects in this group have the option to rollover into the raltegravir group for 12 weeks.
536701|NCT00672932|P1|Participant Flow|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
536702|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
536990|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
536703|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
536704|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
536705|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
536706|NCT00672932|E2|Reported Event|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
536707|NCT00672932|E1|Reported Event|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
536708|NCT00672854|B3|Baseline|Total|Total of all reporting groups
536709|NCT00672854|B2|Baseline|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
536710|NCT00672854|B1|Baseline|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
536711|NCT00672854|P2|Participant Flow|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
536712|NCT00672854|P1|Participant Flow|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
536713|NCT00672854|O2|Outcome|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
536714|NCT00672854|O1|Outcome|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
536715|NCT00672854|E2|Reported Event|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
536716|NCT00672854|E1|Reported Event|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
536717|NCT00672841|B3|Baseline|Total|Total of all reporting groups
536718|NCT00672841|B2|Baseline|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
536719|NCT00672841|B1|Baseline|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
536720|NCT00672841|P2|Participant Flow|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy (i.e., intravenous anidulafungin 200mg on day one, then 100mg daily x 14 days) initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
536721|NCT00672841|P1|Participant Flow|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
536722|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
536723|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
536724|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan (BDG) test for the presumptive early treatment of invasive candidiasis
536725|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
536726|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
536727|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
536728|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
536729|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
536730|NCT00672841|E2|Reported Event|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
536731|NCT00672841|E1|Reported Event|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
536732|NCT00672737|B1|Baseline|Male Volunteers at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
536733|NCT00672737|P1|Participant Flow|Male Volunteers at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
536991|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
536734|NCT00672737|O1|Outcome|Males at Risk for OSA|"Males at risk for obstructive sleep apnea were invited to have a sleep study either at home or at Stanford Sleep Center.~A week after their sleep study (Polysomnography), all volunteers underwent quantitative sensory testing in the laboratory, during which their pain thresholds and tolerances to heat (Heat pain threshold and tolerance) and cold (Cold pain threshold and tolerance) stimuli were assessed, under two different concentrations (1 and 2 mcg/mL, in randomized order) of remifentanil, a short-acting opioid, given as a computer-controlled infusion.~Remifentanil: Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order."
536735|NCT00672737|O1|Outcome|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
536736|NCT00672737|O1|Outcome|Males at Risk for OSA|"Males at risk for obstructive sleep apnea were invited to have a sleep study either at home or at Stanford Sleep Center.~A week after their sleep study (Polysomnography), all volunteers underwent quantitative sensory testing in the laboratory, during which their pain thresholds and tolerances to heat (Heat pain threshold and tolerance) and cold (Cold pain threshold and tolerance) stimuli were assessed, under two different concentrations (1 and 2 mcg/mL, in randomized order) of remifentanil, a short-acting opioid, given as a computer-controlled infusion.~Remifentanil: Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order."
536737|NCT00672737|O1|Outcome|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
536738|NCT00672737|E1|Reported Event|at Risk for Sleep Apnea|After approval from the Institutional Review Board and informed consent, we assessed cold and heat pain thresholds in volunteers after overnight polysomnography (PSG). We measured insulin growth factor binding protein-1 (IGFBP-1) a hypoxia-related serum marker. Pain tests were performed at baseline, placebo, and two effect site concentrations of remifentanil (1 and 2 mg/ml), an mu-opioid agonist. Linear mixed effects regression model was employed to evaluate the association of the lowest oxyhemoglobin saturation (SaO2) during sleep and IGFBP-1 with the changes in pain thresholds after remifentanil administration.
536739|NCT00672646|B4|Baseline|Total|Total of all reporting groups
536740|NCT00672646|B3|Baseline|Placebo|AZD1386 Placebo oral solution
536741|NCT00672646|B2|Baseline|Naproxen|Naproxen 500 mg capsule
536742|NCT00672646|B1|Baseline|AZD1386|AZD1386 95 mg oral solution
536743|NCT00672646|P3|Participant Flow|Placebo|AZD1386 Placebo oral solution
536744|NCT00672646|P2|Participant Flow|Naproxen|Naproxen 500 mg capsule
536745|NCT00672646|P1|Participant Flow|AZD1386|AZD1386 95 mg oral solution
536746|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
536747|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
536748|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
536749|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
536750|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
536751|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
536752|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
536753|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
536754|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
536755|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
536756|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
536757|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
536758|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
536759|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
536760|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
536761|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
536762|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
536763|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
536764|NCT00672646|E3|Reported Event|Placebo|AZD1386 Placebo oral solution
536765|NCT00672646|E2|Reported Event|Naproxen|Naproxen 500 mg capsule
536766|NCT00672646|E1|Reported Event|AZD1386|AZD1386 95 mg oral solution
536767|NCT00672633|B3|Baseline|Total|Total of all reporting groups
536768|NCT00672633|B2|Baseline|Placebo|Corn oil placebo
536769|NCT00672633|B1|Baseline|Lovaza|Treatment Arm
536770|NCT00672633|P2|Participant Flow|Placebo|Corn oil placebo: 4 pills/day orally for 6 months
536771|NCT00672633|P1|Participant Flow|Lovaza|Treatment Arm: 4 grams/day orally for 6 months
536772|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
536773|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
536774|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
536775|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
536776|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
536777|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
536778|NCT00672633|E2|Reported Event|Placebo|Corn oil placebo
536779|NCT00672633|E1|Reported Event|Lovaza|Treatment Arm
536780|NCT00672620|B5|Baseline|Total|Total of all reporting groups
536781|NCT00672620|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536992|NCT00671970|O2|Outcome|Negative Expression|pMAPK negative expression
536993|NCT00671970|O1|Outcome|Positive Expression|pMAPK positive expression
536782|NCT00672620|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536783|NCT00672620|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536784|NCT00672620|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536785|NCT00672620|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period
536786|NCT00672620|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536787|NCT00672620|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536788|NCT00672620|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536789|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536790|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536791|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536792|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536793|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536794|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536795|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536796|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536797|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536798|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536799|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536800|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536801|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536802|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536803|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536804|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536805|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536806|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536807|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536808|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536809|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536810|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536811|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536812|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536813|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536814|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536815|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536816|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536817|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536994|NCT00671970|O2|Outcome|Negative Expression|pAKT negative expression
536818|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536819|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536820|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536821|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536822|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536823|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536824|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536825|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536826|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536827|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536828|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536829|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536830|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536831|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536832|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536833|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536834|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536835|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536836|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536837|NCT00672620|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
536838|NCT00672620|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536839|NCT00672620|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
536840|NCT00672620|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
536841|NCT00672594|B1|Baseline|Treatment|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536842|NCT00672594|P1|Participant Flow|50mg Sunitinib Malate|Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
536843|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536844|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536845|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536846|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536847|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536848|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536849|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536850|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536851|NCT00672594|E1|Reported Event|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
536852|NCT00672555|B1|Baseline|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536853|NCT00672555|P1|Participant Flow|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536854|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536855|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536995|NCT00671970|O1|Outcome|Positive Expression|pAKT positive expression
536996|NCT00671970|O2|Outcome|Loss|PTEN Loss
536856|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536857|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536858|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536859|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536860|NCT00672555|E1|Reported Event|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
536861|NCT00672490|B3|Baseline|Total|Total of all reporting groups
536862|NCT00672490|B2|Baseline|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536863|NCT00672490|B1|Baseline|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536864|NCT00672490|P2|Participant Flow|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536865|NCT00672490|P1|Participant Flow|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536866|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536867|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536868|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536869|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536870|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536871|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536872|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536873|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536874|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536875|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536876|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536877|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536878|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536879|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536880|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536881|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536882|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536883|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536884|NCT00672490|E2|Reported Event|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
536885|NCT00672490|E1|Reported Event|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
536886|NCT00672477|B3|Baseline|Total|Total of all reporting groups
536887|NCT00672477|B2|Baseline|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
536888|NCT00672477|B1|Baseline|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
536889|NCT00672477|P2|Participant Flow|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
536890|NCT00672477|P1|Participant Flow|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
536891|NCT00672477|O2|Outcome|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
536892|NCT00672477|O1|Outcome|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
536893|NCT00672477|O2|Outcome|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
536894|NCT00672477|O1|Outcome|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
536895|NCT00672477|E2|Reported Event|Placebo|Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses).
536896|NCT00672477|E1|Reported Event|Methylnaltrexone Bromide|Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses).
536897|NCT00672438|B3|Baseline|Total|Total of all reporting groups
536898|NCT00672438|B2|Baseline|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil. All other procedures were identical in both groups.
536899|NCT00672438|B1|Baseline|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil prior to a saline placebo infusion. All other procedures were identical in both groups.
536900|NCT00672438|P2|Participant Flow|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil via a computer-controlled infusion pump targeting a steady-state plasma concentration of 100ng/ml. All other procedures were identical in both groups.
536901|NCT00672438|P1|Participant Flow|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil via a computer-controlled infusion targeting steady-state plasma concentration of 100ng/ml prior to a saline placebo infusion. All other procedures were identical in both groups.
536902|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536903|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536904|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536905|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536906|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536907|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536908|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536909|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536910|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536911|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536912|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536913|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536914|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536915|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536916|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536917|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536918|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536919|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536920|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
536921|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536922|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
536923|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536924|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
536925|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536926|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
536927|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536928|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
536929|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
536930|NCT00672438|E1|Reported Event|Alfentanil|Intravenous infusion of Alfentanil
536931|NCT00672256|B1|Baseline|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
536932|NCT00672256|P1|Participant Flow|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
536933|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
536934|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
536935|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
536936|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
536937|NCT00672256|E1|Reported Event|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
536938|NCT00672243|B1|Baseline|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
536939|NCT00672243|P1|Participant Flow|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3, subfamily A (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
536940|NCT00672243|O1|Outcome|Tarceva and Rapamycin|
536941|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
536942|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
536943|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
536944|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
536945|NCT00672243|E1|Reported Event|Tarceva and Rapamycin|
536946|NCT00672204|B1|Baseline|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
536947|NCT00672204|P1|Participant Flow|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
536948|NCT00672204|O1|Outcome|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
536949|NCT00672204|E1|Reported Event|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
536950|NCT00672178|B1|Baseline|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
536951|NCT00672178|P1|Participant Flow|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
536952|NCT00672178|O1|Outcome|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
536953|NCT00672178|E1|Reported Event|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
536954|NCT00672139|B3|Baseline|Total|Total of all reporting groups
536955|NCT00672139|B2|Baseline|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536956|NCT00672139|B1|Baseline|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536957|NCT00672139|P2|Participant Flow|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536958|NCT00672139|P1|Participant Flow|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536959|NCT00672139|O2|Outcome|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536960|NCT00672139|O1|Outcome|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536961|NCT00672139|E2|Reported Event|Methylnaltrexone Bromide 12 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536962|NCT00672139|E1|Reported Event|Methylnaltrexone Bromide 8 mg|"Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.~Subjects received 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information."
536963|NCT00672100|B4|Baseline|Total|Total of all reporting groups
536997|NCT00671970|O1|Outcome|Intact|PTEN Intact
536998|NCT00671970|O2|Outcome|Negative Expression|EGFR vIII negative expression
536964|NCT00672100|B3|Baseline|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536965|NCT00672100|B2|Baseline|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536966|NCT00672100|B1|Baseline|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536967|NCT00672100|P3|Participant Flow|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536968|NCT00672100|P2|Participant Flow|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536969|NCT00672100|P1|Participant Flow|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536970|NCT00672100|O1|Outcome|All Study Participants|All study participants who received Interscalene block (ISB) using 5-20 mL of local anesthetic.
536971|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536972|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536973|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536974|NCT00672100|O3|Outcome|Ropivacaine 20 mL|
536975|NCT00672100|O2|Outcome|Ropivacaine 10 mL|
536976|NCT00672100|O1|Outcome|Ropivacaine 5 mL|
536977|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536978|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536979|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536980|NCT00672100|E3|Reported Event|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536981|NCT00672100|E2|Reported Event|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536982|NCT00672100|E1|Reported Event|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
536983|NCT00671970|B3|Baseline|Total|Total of all reporting groups
536984|NCT00671970|B2|Baseline|WHO Grade IV|WHO Grade IV Malignant Glioma
536985|NCT00671970|B1|Baseline|Who Grade III|Who Grade III Malignant Glioma
536986|NCT00671970|P2|Participant Flow|WHO Grade IV|"WHO Grade IV Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
536987|NCT00671970|P1|Participant Flow|WHO Grade III|"WHO Grade III Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
536988|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
536989|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
536999|NCT00671970|O1|Outcome|Positive Expression|EGFR vIII positive expression
537000|NCT00671970|O2|Outcome|Negative Expression|EGFR negative expression
537001|NCT00671970|O1|Outcome|Positive Expression|EGFR positive expression
537002|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
537003|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
537004|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
537005|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
537006|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
537007|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
537008|NCT00671970|E1|Reported Event|All Patients|All Patients
537009|NCT00671931|B6|Baseline|Total|Total of all reporting groups
537010|NCT00671931|B5|Baseline|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537011|NCT00671931|B4|Baseline|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537012|NCT00671931|B3|Baseline|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537013|NCT00671931|B2|Baseline|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537014|NCT00671931|B1|Baseline|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537015|NCT00671931|P5|Participant Flow|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537016|NCT00671931|P4|Participant Flow|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537062|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537063|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537064|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|
537065|NCT00671853|O1|Outcome|Quetiapine XR|
537066|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
540270|NCT00664560|B4|Baseline|Total|Total of all reporting groups
537017|NCT00671931|P3|Participant Flow|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537018|NCT00671931|P2|Participant Flow|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537019|NCT00671931|P1|Participant Flow|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537020|NCT00671931|O5|Outcome|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537021|NCT00671931|O4|Outcome|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537022|NCT00671931|O3|Outcome|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537023|NCT00671931|O2|Outcome|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537024|NCT00671931|O1|Outcome|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537025|NCT00671931|E5|Reported Event|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537026|NCT00671931|E4|Reported Event|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537027|NCT00671931|E3|Reported Event|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537028|NCT00671931|E2|Reported Event|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537029|NCT00671931|E1|Reported Event|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
537030|NCT00671918|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
537031|NCT00671918|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc-99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
537032|NCT00671918|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
537033|NCT00671918|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
537034|NCT00671918|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
537035|NCT00671879|B4|Baseline|Total|Total of all reporting groups
537036|NCT00671879|B3|Baseline|Placebo|Placebo treatment arm
537037|NCT00671879|B2|Baseline|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
537038|NCT00671879|B1|Baseline|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
537039|NCT00671879|P3|Participant Flow|Placebo|Placebo treatment arm
537040|NCT00671879|P2|Participant Flow|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
537041|NCT00671879|P1|Participant Flow|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
537042|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
537043|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
537044|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
537045|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
537046|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
537047|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol SR 700 mg twice daily
537048|NCT00671879|E3|Reported Event|Placebo|Placebo treatment arm
537049|NCT00671879|E2|Reported Event|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
537050|NCT00671879|E1|Reported Event|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
537051|NCT00671853|B3|Baseline|Total|Total of all reporting groups
537052|NCT00671853|B2|Baseline|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537053|NCT00671853|B1|Baseline|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537054|NCT00671853|P2|Participant Flow|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537055|NCT00671853|P1|Participant Flow|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537056|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537057|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537058|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537059|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537060|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537061|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537067|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537068|NCT00671853|E2|Reported Event|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537069|NCT00671853|E1|Reported Event|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
537070|NCT00671788|B1|Baseline|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
537071|NCT00671788|P1|Participant Flow|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
537072|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
537073|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
537074|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
537075|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
537076|NCT00671788|E1|Reported Event|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
537077|NCT00671749|B1|Baseline|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537078|NCT00671749|P1|Participant Flow|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537079|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537080|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537081|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537082|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537083|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537084|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537085|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537086|NCT00671749|E1|Reported Event|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
537087|NCT00671723|B4|Baseline|Total|Total of all reporting groups
537088|NCT00671723|B3|Baseline|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537089|NCT00671723|B2|Baseline|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537090|NCT00671723|B1|Baseline|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537148|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537091|NCT00671723|P3|Participant Flow|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537092|NCT00671723|P2|Participant Flow|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537093|NCT00671723|P1|Participant Flow|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537094|NCT00671723|O3|Outcome|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537095|NCT00671723|O2|Outcome|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537096|NCT00671723|O1|Outcome|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537097|NCT00671723|O3|Outcome|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537098|NCT00671723|O2|Outcome|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537099|NCT00671723|O1|Outcome|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537100|NCT00671723|E3|Reported Event|Dornase Alpha|"2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Dornase alpha: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537101|NCT00671723|E2|Reported Event|Hypertonic Saline|"Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Hypertonic Saline: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537102|NCT00671723|E1|Reported Event|Normal Saline|"Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).~Normal saline:: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl)."
537103|NCT00671671|B3|Baseline|Total|Total of all reporting groups
537104|NCT00671671|B2|Baseline|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537105|NCT00671671|B1|Baseline|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537106|NCT00671671|P2|Participant Flow|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537107|NCT00671671|P1|Participant Flow|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537373|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537108|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537109|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537110|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537111|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537112|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537113|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537114|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537115|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537116|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537117|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537118|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537119|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537120|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537121|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537122|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537123|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537124|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
542651|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
537125|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537126|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537127|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537128|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537129|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537130|NCT00671671|E2|Reported Event|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
537131|NCT00671671|E1|Reported Event|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
537132|NCT00671606|B1|Baseline|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
537133|NCT00671606|P1|Participant Flow|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
537134|NCT00671606|O1|Outcome|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
537135|NCT00671606|E1|Reported Event|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
537136|NCT00671554|B1|Baseline|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
537137|NCT00671554|P1|Participant Flow|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG). Four 1 ml doses of 250,000 dendritomas Subcutaneous (SQ) at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
537138|NCT00671554|O1|Outcome|Melaxin and BCG|"Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration~Melaxin (autologous dendritoma vaccine) and BCG: Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration."
537139|NCT00671554|O1|Outcome|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
537140|NCT00671554|E1|Reported Event|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
537141|NCT00671528|B4|Baseline|Total|Total of all reporting groups
537142|NCT00671528|B3|Baseline|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537143|NCT00671528|B2|Baseline|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537144|NCT00671528|B1|Baseline|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537145|NCT00671528|P3|Participant Flow|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537146|NCT00671528|P2|Participant Flow|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537147|NCT00671528|P1|Participant Flow|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537379|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537149|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537150|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537151|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537152|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537153|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537154|NCT00671528|E3|Reported Event|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537155|NCT00671528|E2|Reported Event|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537156|NCT00671528|E1|Reported Event|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
537157|NCT00671515|B1|Baseline|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
537158|NCT00671515|P1|Participant Flow|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
537159|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
537160|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
537161|NCT00671515|E1|Reported Event|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
537162|NCT00671502|B4|Baseline|Total|Total of all reporting groups
537163|NCT00671502|B3|Baseline|Placebo Tablet|tablet placebo no experimental formulation
537164|NCT00671502|B2|Baseline|Carisoprodol 500mg Tablet|tablet experimental formulation
537165|NCT00671502|B1|Baseline|Carisoprodol 700mg|tablet experimental formulation
537166|NCT00671502|P3|Participant Flow|Placebo Tablet|tablet placebo no experimental formulation
537167|NCT00671502|P2|Participant Flow|Carisoprodol 500mg Tablet|tablet experimental formulation
537168|NCT00671502|P1|Participant Flow|Carisoprodol 700mg|tablet experimental formulation
537169|NCT00671502|O3|Outcome|Placebo Tablets|placebo tablets treatment arm
537170|NCT00671502|O2|Outcome|Carisoprodol 700mg Tablets|carisoprodol 700mg tablets treatment arm
537171|NCT00671502|O1|Outcome|Carisoprodol 500mg Tablets|carisoprodol 500mg tablets treatment arm
537172|NCT00671502|E3|Reported Event|Placebo Tablet|tablet placebo no experimental formulation
537173|NCT00671502|E2|Reported Event|Carisoprodol 500mg Tablet|tablet experimental formulation
537174|NCT00671502|E1|Reported Event|Carisoprodol 700mg|tablet experimental formulation
537175|NCT00671437|B1|Baseline|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537176|NCT00671437|P1|Participant Flow|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537177|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537178|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
542652|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
537179|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537180|NCT00671437|O3|Outcome|Progressive Disease by Both CT and PET/CT|
537181|NCT00671437|O2|Outcome|Disease Control by CT and Progressive Disease by PET/CT|
537182|NCT00671437|O1|Outcome|Disease Control by CT and PET/CT|
537183|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537184|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537185|NCT00671437|O4|Outcome|Total (Overall PET Response)|
537186|NCT00671437|O3|Outcome|Progressive Metabolic Disease (Overall PET Response)|
537187|NCT00671437|O2|Outcome|Stable Metabolic Disease (Overall PET Response)|
537188|NCT00671437|O1|Outcome|Partial Metabolic Response (Overall PET Response)|
537189|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537190|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537191|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537192|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537193|NCT00671437|E1|Reported Event|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
537194|NCT00671177|B3|Baseline|Total|Total of all reporting groups
537195|NCT00671177|B2|Baseline|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
537196|NCT00671177|B1|Baseline|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
537197|NCT00671177|P2|Participant Flow|Standard Air Colonoscopy|"Standard Air Colonoscopy~standard air colonoscopy: air instillation in colon for visualization"
537198|NCT00671177|P1|Participant Flow|Water Immersion Colonoscopy|"Water Immersion Colonoscopy~water immersion colonoscopy: instillation of 300cc of water in the rectum"
537199|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
537200|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
537201|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
537202|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
537203|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
537204|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
537205|NCT00671177|E2|Reported Event|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
537206|NCT00671177|E1|Reported Event|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
537207|NCT00671060|B3|Baseline|Total|Total of all reporting groups
537208|NCT00671060|B2|Baseline|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537209|NCT00671060|B1|Baseline|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537574|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537210|NCT00671060|P2|Participant Flow|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537211|NCT00671060|P1|Participant Flow|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537212|NCT00671060|O2|Outcome|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537213|NCT00671060|O1|Outcome|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537214|NCT00671060|E2|Reported Event|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537215|NCT00671060|E1|Reported Event|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
537216|NCT00670982|B3|Baseline|Total|Total of all reporting groups
537217|NCT00670982|B2|Baseline|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
537218|NCT00670982|B1|Baseline|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
537219|NCT00670982|P2|Participant Flow|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every two weeks, vinorelbine (25mg/m2) intravenously once per week, and trastuzumab(4 mg/kg) intravenously once per week.
537220|NCT00670982|P1|Participant Flow|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every 2 weeks and vinorelbine(25mg/m2) intravenously once per week, and trastuzumab (4 mg/kg) intravenously once per week
537221|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
537222|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
537223|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
537224|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
537225|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
537226|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
537227|NCT00670982|E1|Reported Event|All Study Participants|All participants received the same study treatment, so cumulative adverse events are reported here.
537228|NCT00670956|B1|Baseline|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
537229|NCT00670956|P1|Participant Flow|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
537230|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
537231|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
537232|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
537233|NCT00670956|E1|Reported Event|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
537234|NCT00670930|B3|Baseline|Total|Total of all reporting groups
537374|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
537235|NCT00670930|B2|Baseline|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
537236|NCT00670930|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
537237|NCT00670930|P2|Participant Flow|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
537238|NCT00670930|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
537239|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
537240|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
537241|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
537242|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
537243|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
537244|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
537245|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
537261|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537632|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537246|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
537247|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
537248|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
537249|NCT00670930|E2|Reported Event|Placebo|Placebo
537250|NCT00670930|E1|Reported Event|Omalizumab|Omalizumab
537251|NCT00670800|B3|Baseline|Total|Total of all reporting groups
537252|NCT00670800|B2|Baseline|Normal Controls|Normal controls are matched for age and education and screened for insulin resistance. Controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles, and lack hirsutism and acne. Exclusion criteria: Left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, claustrophobia, contraindications to MRI (including pacemakers, pumps, surgical clips or metallic surgical devices), smoking within the last 6 months, use of hormones or insulin sensitizing mediation within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids, cardiac or pulmonary insufficiency, active liver disease and transaminases elevations >2.5 X normal values, renal insufficiency (plasma creatinine level ≥1.4 mg/dl), use of centrally acting medications, allergy to any opioid medication, 300 lbs maximum weight limit (which is the max
537253|NCT00670800|B1|Baseline|PCOS Affected Women - Metformin|Right handed women who don’t smoke and who drink very little will be considered eligible. Women with the following conditions (exclusion criteria) may not participate: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics).
537254|NCT00670800|P2|Participant Flow|Women Controls Without PCOS|"Control group is comprised of subjects without PCOS. These women have normal menstrual cycles and no evidence of insulin resistance (fasting HOMA2 IR of 80%S or more).~Exclusion criteria: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics)."
537255|NCT00670800|P1|Participant Flow|Women Affected With PCOS - Metformin|The Polycystic Ovary Syndrome (PCOS) affected group is comprised of subjects with insulin resistant PCOS, defined as having irregular menstrual cycles and hyperandrogenism with other causes ruled out. Insulin resistance will be identified as fasting homeostasis model assessment insulin resistance (HOMA2-IR) of 60%S or less.
537256|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
537257|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537258|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537259|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
537260|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537375|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537262|NCT00670800|O3|Outcome|Normal Control Women|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
537263|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537264|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537265|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
537266|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537267|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
537268|NCT00670800|E2|Reported Event|PCOS Affected Women on Metformin|Women with PCOS and insulin resistance
537269|NCT00670800|E1|Reported Event|Normal Controls|Women without PCOS
537270|NCT00670748|B5|Baseline|Total|Total of all reporting groups
537271|NCT00670748|B4|Baseline|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
537272|NCT00670748|B3|Baseline|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
537273|NCT00670748|B2|Baseline|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537274|NCT00670748|B1|Baseline|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537307|NCT00670631|P1|Participant Flow|Tandem Autologous Stem Cell Transplant|"Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days."
537376|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537377|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
537275|NCT00670748|P4|Participant Flow|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
537276|NCT00670748|P3|Participant Flow|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
537277|NCT00670748|P2|Participant Flow|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537278|NCT00670748|P1|Participant Flow|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537279|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
537280|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
537281|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537365|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
537366|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537367|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537282|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537283|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
537284|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
537285|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537286|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537287|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
537288|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
537368|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
537369|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537370|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537289|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537290|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537291|NCT00670748|E4|Reported Event|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
537292|NCT00670748|E3|Reported Event|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
537293|NCT00670748|E2|Reported Event|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537294|NCT00670748|E1|Reported Event|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
537295|NCT00670709|B3|Baseline|Total|Total of all reporting groups
537296|NCT00670709|B2|Baseline|Healthy Controls|Healthy control subjects
537297|NCT00670709|B1|Baseline|Huntington Disease|Subjects with mild or moderate Huntington's Disease
537298|NCT00670709|P2|Participant Flow|Healthy Controls|Healthy control subjects
537299|NCT00670709|P1|Participant Flow|Huntington Disease|Subjects with mild or moderate Huntington's Disease
537300|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
537301|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
537302|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
537303|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
537304|NCT00670709|E2|Reported Event|Healthy Controls|Healthy control subjects
537305|NCT00670709|E1|Reported Event|Huntington Disease|Subjects with mild or moderate Huntington's Disease
537306|NCT00670631|B1|Baseline|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days."
537378|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537308|NCT00670631|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles."
537309|NCT00670631|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles."
537310|NCT00670631|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days.~Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.~Once recovered, participants start thalidomide daily & dexamethasone x 4 days every 21 days.~Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.~tandem autologous transplantation: DPACE: dexamethasone 20 mg days 1-4 and 8-11, cisplatin 10 mg/m2 days 1-4, Adriamycin 10 mg/m2 days"
537311|NCT00670631|E1|Reported Event|Tandem Autologous Stem Cell Transplant|"Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.~After collection, participants will receive dexamethasone x 4 days every 14 days."
537312|NCT00670540|B1|Baseline|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537313|NCT00670540|P1|Participant Flow|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537314|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537315|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537316|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537317|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537318|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537319|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537320|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537321|NCT00670540|E1|Reported Event|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
537322|NCT00670462|B3|Baseline|Total|Total of all reporting groups
537323|NCT00670462|B2|Baseline|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537324|NCT00670462|B1|Baseline|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537325|NCT00670462|P2|Participant Flow|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537326|NCT00670462|P1|Participant Flow|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537633|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537327|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537328|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537329|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537330|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537331|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537332|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537333|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537334|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537335|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537371|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
537634|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537336|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537337|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537338|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537339|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537340|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537341|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537342|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537343|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537344|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
537345|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537372|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537346|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537347|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537348|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537349|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537350|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537351|NCT00670462|E2|Reported Event|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
537352|NCT00670462|E1|Reported Event|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
537353|NCT00670449|B5|Baseline|Total|Total of all reporting groups
537354|NCT00670449|B4|Baseline|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
537355|NCT00670449|B3|Baseline|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
537356|NCT00670449|B2|Baseline|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537357|NCT00670449|B1|Baseline|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537358|NCT00670449|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
537359|NCT00670449|P3|Participant Flow|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
537360|NCT00670449|P2|Participant Flow|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537361|NCT00670449|P1|Participant Flow|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537362|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
537363|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537364|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537635|NCT00669903|O4|Outcome|Placebo|Placebo
537380|NCT00670449|E4|Reported Event|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
537381|NCT00670449|E3|Reported Event|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
537382|NCT00670449|E2|Reported Event|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
537383|NCT00670449|E1|Reported Event|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
537384|NCT00670306|B1|Baseline|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
537385|NCT00670306|P1|Participant Flow|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
537386|NCT00670306|O1|Outcome|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
537387|NCT00670306|E1|Reported Event|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
537388|NCT00670267|B1|Baseline|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
537389|NCT00670267|P1|Participant Flow|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
537390|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
537391|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
537392|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
537393|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
537394|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|"Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.~nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in."
537395|NCT00670267|E1|Reported Event|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
537396|NCT00670241|B4|Baseline|Total|Total of all reporting groups
537397|NCT00670241|B3|Baseline|Gel Vehicle|Gel Vehicle for up to 8 weeks
537398|NCT00670241|B2|Baseline|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537399|NCT00670241|B1|Baseline|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537400|NCT00670241|P3|Participant Flow|Gel Vehicle|Gel Vehicle for up to 8 weeks
537401|NCT00670241|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537402|NCT00670241|P1|Participant Flow|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537403|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
537404|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537405|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537406|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
537407|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537408|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537409|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
537410|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537411|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537412|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
537413|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537414|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537415|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
537416|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537417|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537418|NCT00670241|E3|Reported Event|Gel Vehicle|Gel Vehicle for up to 8 weeks
537419|NCT00670241|E2|Reported Event|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
537420|NCT00670241|E1|Reported Event|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
537421|NCT00670228|B3|Baseline|Total|Total of all reporting groups
537422|NCT00670228|B2|Baseline|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
537423|NCT00670228|B1|Baseline|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
537424|NCT00670228|P2|Participant Flow|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
537425|NCT00670228|P1|Participant Flow|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
537426|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
537427|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
537428|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
537429|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
537430|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
537431|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
537432|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
537433|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
537434|NCT00670228|E2|Reported Event|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
537435|NCT00670228|E1|Reported Event|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
537436|NCT00670202|B3|Baseline|Total|Total of all reporting groups
537437|NCT00670202|B2|Baseline|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
537438|NCT00670202|B1|Baseline|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
537439|NCT00670202|P2|Participant Flow|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
537440|NCT00670202|P1|Participant Flow|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
537441|NCT00670202|O2|Outcome|Drug: Placebo Oral Tablet|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days"
537442|NCT00670202|O1|Outcome|Drug: Fasudil Hydrochloride|"Fasudil hydrochloride 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
537443|NCT00670202|E2|Reported Event|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
537444|NCT00670202|E1|Reported Event|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
537445|NCT00670111|B4|Baseline|Total|Total of all reporting groups
537446|NCT00670111|B3|Baseline|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
537447|NCT00670111|B2|Baseline|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
537448|NCT00670111|B1|Baseline|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
537449|NCT00670111|P3|Participant Flow|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
537450|NCT00670111|P2|Participant Flow|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
537451|NCT00670111|P1|Participant Flow|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
537452|NCT00670111|O2|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
537453|NCT00670111|O1|Outcome|Rate Adaptive Pacing (RAP) On at Six Months|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
537454|NCT00670111|O2|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for cardiopulmonary exercise test (CPX) at one month.
537455|NCT00670111|O1|Outcome|Rate Adaptive Pacing (RAP) On at One Month|Rate Adaptive Pacing (RAP) On for cardiopulmonary exercise test (CPX) at one month.
537456|NCT00670111|E2|Reported Event|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group. Adverse events were collected for all subjects, also for non-randomized patients.
537457|NCT00670111|E1|Reported Event|All Implanted Patients|All patients from the RAP On then Off group and from the RAP Off then On group.
537458|NCT00670007|B1|Baseline|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week
537459|NCT00670007|P1|Participant Flow|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week
537460|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537461|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537462|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537463|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537464|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537465|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537466|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537467|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537468|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537469|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537470|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537471|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537472|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537473|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537474|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537475|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537476|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537477|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537478|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537479|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537480|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
537481|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
537482|NCT00670007|E1|Reported Event|Zemaira®|The safety population comprised all subjects enrolled in study CE1226_3001 and who received at least 1 administration of Zemaira® during study CE1226_3001.
537483|NCT00669955|B3|Baseline|Total|Total of all reporting groups
537484|NCT00669955|B2|Baseline|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537485|NCT00669955|B1|Baseline|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537486|NCT00669955|P2|Participant Flow|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537487|NCT00669955|P1|Participant Flow|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537488|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537489|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537490|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537491|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537492|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537636|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537493|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537494|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537495|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537496|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537497|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537498|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537499|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537500|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537501|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537502|NCT00669955|E2|Reported Event|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
537503|NCT00669955|E1|Reported Event|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
537504|NCT00669942|B13|Baseline|Total|Total of all reporting groups
537505|NCT00669942|B12|Baseline|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
537506|NCT00669942|B11|Baseline|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
537507|NCT00669942|B10|Baseline|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537508|NCT00669942|B9|Baseline|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537509|NCT00669942|B8|Baseline|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537510|NCT00669942|B7|Baseline|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537511|NCT00669942|B6|Baseline|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537512|NCT00669942|B5|Baseline|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
537513|NCT00669942|B4|Baseline|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537514|NCT00669942|B3|Baseline|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537515|NCT00669942|B2|Baseline|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537516|NCT00669942|B1|Baseline|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537517|NCT00669942|P12|Participant Flow|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
537518|NCT00669942|P11|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
537519|NCT00669942|P10|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537520|NCT00669942|P9|Participant Flow|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537521|NCT00669942|P8|Participant Flow|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537522|NCT00669942|P7|Participant Flow|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537523|NCT00669942|P6|Participant Flow|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537524|NCT00669942|P5|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
537525|NCT00669942|P4|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537526|NCT00669942|P3|Participant Flow|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537527|NCT00669942|P2|Participant Flow|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537528|NCT00669942|P1|Participant Flow|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537529|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537530|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537531|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
542653|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
537532|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537533|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537534|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537535|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537536|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537537|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537538|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537539|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537540|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537541|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537542|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537543|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537544|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537545|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537546|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537547|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537548|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537549|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537550|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537551|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537552|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537553|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537554|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537555|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537556|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537557|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537558|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537559|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537560|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537561|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537562|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537563|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537564|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537565|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537566|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537567|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537568|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537569|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537570|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537571|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537572|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537573|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537737|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537575|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537576|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537577|NCT00669942|E12|Reported Event|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
537578|NCT00669942|E11|Reported Event|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
537579|NCT00669942|E10|Reported Event|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537580|NCT00669942|E9|Reported Event|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537581|NCT00669942|E8|Reported Event|Parts 2 and 3 - AIN457 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537582|NCT00669942|E7|Reported Event|Parts 2 and 3 - AIN457 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537583|NCT00669942|E6|Reported Event|Parts 2 and 3 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
537584|NCT00669942|E5|Reported Event|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
537585|NCT00669942|E4|Reported Event|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
537586|NCT00669942|E3|Reported Event|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
537587|NCT00669942|E2|Reported Event|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
537588|NCT00669942|E1|Reported Event|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
537589|NCT00669916|B3|Baseline|Total|Total of all reporting groups
537590|NCT00669916|B2|Baseline|Placebo|Placebo was administered intravenously as a single dose.
537591|NCT00669916|B1|Baseline|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537592|NCT00669916|P2|Participant Flow|Placebo|Placebo was administered intravenously as a single dose.
537593|NCT00669916|P1|Participant Flow|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537594|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537595|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
537596|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537597|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537598|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537599|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537600|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537601|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537602|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
537603|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
537604|NCT00669916|E2|Reported Event|Placebo|Placebo was administered intravenously as a single dose.
537605|NCT00669916|E1|Reported Event|AIN457A|AIN457A 3mg/kg was administered intravenously as a single dose.
537606|NCT00669903|B5|Baseline|Total|Total of all reporting groups
537607|NCT00669903|B4|Baseline|Placebo|Placebo
537608|NCT00669903|B3|Baseline|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537609|NCT00669903|B2|Baseline|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537610|NCT00669903|B1|Baseline|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537611|NCT00669903|P4|Participant Flow|Placebo|Placebo
537612|NCT00669903|P3|Participant Flow|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537613|NCT00669903|P2|Participant Flow|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537614|NCT00669903|P1|Participant Flow|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537615|NCT00669903|O4|Outcome|Placebo|Placebo
537616|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537617|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537618|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537619|NCT00669903|O4|Outcome|Placebo|Placebo
537620|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537621|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537622|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537623|NCT00669903|O4|Outcome|Placebo|Placebo
537624|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537625|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537626|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537627|NCT00669903|O4|Outcome|Placebo|Placebo
537628|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537629|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537630|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537631|NCT00669903|O4|Outcome|Placebo|Placebo
537637|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537638|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537639|NCT00669903|E4|Reported Event|Placebo|Placebo
537640|NCT00669903|E3|Reported Event|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
537641|NCT00669903|E2|Reported Event|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
537642|NCT00669903|E1|Reported Event|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
537643|NCT00669877|B1|Baseline|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
537644|NCT00669877|P1|Participant Flow|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
537645|NCT00669877|O1|Outcome|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
537646|NCT00669877|O1|Outcome|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
537647|NCT00669877|E1|Reported Event|Hyper-CVAD|Hyper-CVAD (odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Rituximab 375 mg/m2 days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses. Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3. Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Vincristine 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses). Dexamethasone 40 mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses). G-CSF 10 mg/kg/day (rounded) until neutrophil recovery 1 x 10^9/L or higher can be substituted or can be added to pegfilgrastim if neutrophils have not recovered to 1 x 10^9/L by day 21.
537648|NCT00669864|B1|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537649|NCT00669864|P1|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537650|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537651|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537652|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537653|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537654|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537655|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537656|NCT00669864|E1|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
537738|NCT00669331|O2|Outcome|Control|"Matched control - inhaled mannitol 50mg~Matched control: 50mg dose of Mannitol BD for 52 weeks"
537657|NCT00669682|B1|Baseline|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
537658|NCT00669682|P1|Participant Flow|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
537659|NCT00669682|O2|Outcome|Negative Optivol Status|These patients have transthoracic impedance measurements that do not suggest fluid overload
537660|NCT00669682|O1|Outcome|Positive Optivol Status|These patients have transthoracic impedance measurements that suggest fluid overload
537661|NCT00669682|E1|Reported Event|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
537662|NCT00669617|B1|Baseline|Total Population|Participants were randomized to one of five treatment sequences. Each treatment sequence comprised 5 double-blind, single dose treatment periods (Periods I to V), separated by a washout period of 4-7 days. Participants received each of the 5 blinded-treatments: indacaterol 150 μg, indacaterol 300 μg, salmeterol/fluticasone 50/500 μg, salbutamol 200 μg and placebo.
537663|NCT00669617|P5|Participant Flow|Placebo, Salbut, Salm/Flut , Ind 300μg, Ind 150μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/Flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537664|NCT00669617|P4|Participant Flow|Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/Flut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537665|NCT00669617|P3|Participant Flow|Salm/Flut, Placebo, Ind 150μg, Salbut, Ind 300μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537666|NCT00669617|P2|Participant Flow|Ind 300μg, Ind 150μg, Salbut, Salm/Flut, Placebo|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537667|NCT00669617|P1|Participant Flow|Ind 150μg, Salm/Flut, Ind 300μg, Placebo, Salbut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537668|NCT00669617|O5|Outcome|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537669|NCT00669617|O4|Outcome|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537670|NCT00669617|O3|Outcome|Placebo|Participants received placebo to indacaterol delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous one by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537671|NCT00669617|O2|Outcome|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and a placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537672|NCT00669617|O1|Outcome|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537673|NCT00669617|E5|Reported Event|Placebo|Participants received placebo to indacaterol delivered via SDDPI, a placebo to salmeterol/fluticasone delivered via MDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537674|NCT00669617|E4|Reported Event|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537675|NCT00669617|E3|Reported Event|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537676|NCT00669617|E2|Reported Event|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537677|NCT00669617|E1|Reported Event|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
537678|NCT00669578|B3|Baseline|Total|Total of all reporting groups
537679|NCT00669578|B2|Baseline|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
537680|NCT00669578|B1|Baseline|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537681|NCT00669578|P2|Participant Flow|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537682|NCT00669578|P1|Participant Flow|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
537683|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
537684|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537685|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
537686|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537687|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
537688|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537689|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
537690|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537691|NCT00669578|O2|Outcome|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537739|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol 400mg~Inhaled mannitol: 400mg dose of Mannitol BD for 52 weeks"
537740|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537741|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537692|NCT00669578|O1|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
537693|NCT00669578|E1|Reported Event|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
537694|NCT00669552|B1|Baseline|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
537695|NCT00669552|P1|Participant Flow|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
537696|NCT00669552|O1|Outcome|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
537697|NCT00669552|E1|Reported Event|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
537698|NCT00669539|B3|Baseline|Total|Total of all reporting groups
537699|NCT00669539|B2|Baseline|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537700|NCT00669539|B1|Baseline|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537701|NCT00669539|P2|Participant Flow|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537702|NCT00669539|P1|Participant Flow|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537703|NCT00669539|O2|Outcome|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537704|NCT00669539|O1|Outcome|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537705|NCT00669539|E2|Reported Event|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537706|NCT00669539|E1|Reported Event|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
537707|NCT00669461|B1|Baseline|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
537708|NCT00669461|P1|Participant Flow|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
537709|NCT00669461|O1|Outcome|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
537710|NCT00669461|O1|Outcome|Lubiprostone|Lubiprostone 24 micrograms po BID given for total of 4 weeks
537711|NCT00669461|E1|Reported Event|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
537712|NCT00669396|B3|Baseline|Total|Total of all reporting groups
537713|NCT00669396|B2|Baseline|Levonorgestrel|Oral levonorgestrel
537714|NCT00669396|B1|Baseline|Copper T380 IUD|IUD
537715|NCT00669396|P2|Participant Flow|Levonorgestrel|Oral levonorgestrel
537716|NCT00669396|P1|Participant Flow|Copper T380 IUD|IUD
537717|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
537718|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
537719|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
537720|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
537721|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
537722|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
537723|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
537724|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
537725|NCT00669396|E2|Reported Event|Levonorgestrel|Oral levonorgestrel
537726|NCT00669396|E1|Reported Event|Copper T380 IUD|IUD
537727|NCT00669331|B3|Baseline|Total|Total of all reporting groups
537728|NCT00669331|B2|Baseline|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537729|NCT00669331|B1|Baseline|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537730|NCT00669331|P2|Participant Flow|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537731|NCT00669331|P1|Participant Flow|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537732|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537733|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537734|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537735|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537736|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537742|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537743|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537744|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537745|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537746|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537747|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537748|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537749|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537750|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537751|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537752|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537753|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537754|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537755|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537756|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537757|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537758|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537759|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537760|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537761|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537762|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537763|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537764|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537765|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537766|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537767|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537768|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537769|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537770|NCT00669331|E2|Reported Event|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
537771|NCT00669331|E1|Reported Event|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
537772|NCT00669318|B1|Baseline|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
537773|NCT00669318|P1|Participant Flow|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
537774|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
537775|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
537808|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
538273|NCT00667693|E1|Reported Event|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
537776|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
537777|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
537778|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
537779|NCT00669318|E1|Reported Event|Treatment (Pentostatin, Alemtuzumab, Rituximab)|sargramostim
537780|NCT00669279|B3|Baseline|Total|Total of all reporting groups
537781|NCT00669279|B2|Baseline|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
537782|NCT00669279|B1|Baseline|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
537783|NCT00669279|P2|Participant Flow|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
537784|NCT00669279|P1|Participant Flow|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
537785|NCT00669279|O2|Outcome|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
537786|NCT00669279|O1|Outcome|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
537787|NCT00669279|E2|Reported Event|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
537788|NCT00669279|E1|Reported Event|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
537789|NCT00669240|B1|Baseline|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537790|NCT00669240|P1|Participant Flow|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537791|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537792|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537793|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
542654|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
537794|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537795|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537796|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537797|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537798|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537799|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537800|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537801|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537802|NCT00669240|E1|Reported Event|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
537803|NCT00669214|B3|Baseline|Total|Total of all reporting groups
537804|NCT00669214|B2|Baseline|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537805|NCT00669214|B1|Baseline|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537806|NCT00669214|P2|Participant Flow|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537807|NCT00669214|P1|Participant Flow|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537901|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
542655|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
537809|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537810|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537811|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537812|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537813|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537814|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537815|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537816|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537817|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537818|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537819|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537820|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537821|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537822|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537823|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537824|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537825|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537826|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537827|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537828|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537829|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
538355|NCT00667576|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
537830|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537831|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537832|NCT00669214|E6|Reported Event|Efalizumab: Follow-Up Period|
537833|NCT00669214|E5|Reported Event|Placebo: Follow-Up Period|
537834|NCT00669214|E4|Reported Event|Efalizumab: Open-Label Period|
537835|NCT00669214|E3|Reported Event|Placebo: Open-Label Period|
537836|NCT00669214|E2|Reported Event|Efalizumab: Double-Blind Period|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537837|NCT00669214|E1|Reported Event|Placebo: Double-Blind Period|All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
537838|NCT00669110|B3|Baseline|Total|Total of all reporting groups
537839|NCT00669110|B2|Baseline|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537840|NCT00669110|B1|Baseline|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537841|NCT00669110|P2|Participant Flow|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537842|NCT00669110|P1|Participant Flow|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537843|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537844|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537845|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537846|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537847|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537848|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537849|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537850|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537851|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537852|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
538356|NCT00667576|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
537853|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537854|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537855|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537856|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537857|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537858|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537859|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537860|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537861|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537862|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537863|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537864|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537865|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537866|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537867|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537868|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537869|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537870|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537871|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
542656|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
537872|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537873|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537874|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537875|NCT00669110|E2|Reported Event|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
537876|NCT00669110|E1|Reported Event|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
537877|NCT00669071|B1|Baseline|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
537878|NCT00669071|P1|Participant Flow|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
537879|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537880|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537881|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537882|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537883|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537884|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537885|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537886|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537887|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537888|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537889|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537890|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537891|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537892|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537893|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
537894|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
537895|NCT00669071|E1|Reported Event|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
537896|NCT00669032|B3|Baseline|Total|Total of all reporting groups
537897|NCT00669032|B2|Baseline|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537898|NCT00669032|B1|Baseline|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537899|NCT00669032|P2|Participant Flow|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537900|NCT00669032|P1|Participant Flow|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
538357|NCT00667576|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
537902|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537903|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537904|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537905|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537906|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537907|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537908|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537909|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537910|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537911|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537912|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537913|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537914|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537915|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537916|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537917|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537918|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537919|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537920|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537921|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537922|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537923|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537924|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537925|NCT00669032|E2|Reported Event|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537926|NCT00669032|E1|Reported Event|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
537927|NCT00669019|B1|Baseline|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
537928|NCT00669019|P1|Participant Flow|Saracatinib|Patients receive saracatinib 175 mg oral, once daily in the absence of disease progression or unacceptable toxicity.
537929|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
537930|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
537931|NCT00669019|E1|Reported Event|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
537932|NCT00668902|B4|Baseline|Total|Total of all reporting groups
537933|NCT00668902|B3|Baseline|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537934|NCT00668902|B2|Baseline|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537935|NCT00668902|B1|Baseline|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537936|NCT00668902|P3|Participant Flow|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537937|NCT00668902|P2|Participant Flow|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537938|NCT00668902|P1|Participant Flow|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537939|NCT00668902|O3|Outcome|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537940|NCT00668902|O2|Outcome|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537941|NCT00668902|O1|Outcome|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537942|NCT00668902|E3|Reported Event|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537943|NCT00668902|E2|Reported Event|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537944|NCT00668902|E1|Reported Event|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
537945|NCT00668863|B1|Baseline|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537946|NCT00668863|P1|Participant Flow|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537947|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537948|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537949|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537950|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537951|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537952|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537953|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537954|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537955|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537956|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537957|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537958|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537959|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537960|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537961|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537962|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
538020|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
537963|NCT00668863|E1|Reported Event|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
537964|NCT00668811|B1|Baseline|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
537965|NCT00668811|P1|Participant Flow|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
537966|NCT00668811|O1|Outcome|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
537967|NCT00668811|O1|Outcome|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
537968|NCT00668811|E1|Reported Event|Treatment Arm - Sutent|"Sutent 37.5 mg/day will be given orally.~SU011248, Sutent: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles."
537969|NCT00668785|B1|Baseline|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
537970|NCT00668785|P1|Participant Flow|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
537971|NCT00668785|O1|Outcome|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
537972|NCT00668785|E1|Reported Event|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
537973|NCT00668746|B3|Baseline|Total|Total of all reporting groups
537974|NCT00668746|B2|Baseline|No Drug Intervention|A control consisting of no drug intervention
537975|NCT00668746|B1|Baseline|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
537976|NCT00668746|P2|Participant Flow|No Drug Intervention|A control consisting of no drug intervention
537977|NCT00668746|P1|Participant Flow|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
537978|NCT00668746|O6|Outcome|Control Group at Day 180|
537979|NCT00668746|O5|Outcome|Control Group at Day 30|
537980|NCT00668746|O4|Outcome|Control Group at Baseline|
537981|NCT00668746|O3|Outcome|Minocycline Group at Day 180|
537982|NCT00668746|O2|Outcome|Minocycline Group at Day 30|
537983|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
537984|NCT00668746|O6|Outcome|Control Group at 180 Days|
537985|NCT00668746|O5|Outcome|Control Group at 30 Days|
537986|NCT00668746|O4|Outcome|Control Group at Baseline|
537987|NCT00668746|O3|Outcome|Micocycline Group at 180 Days|
537988|NCT00668746|O2|Outcome|Minocycline Group at 30 Days|
537989|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
537990|NCT00668746|O2|Outcome|No Drug Intervention|A control consisting of no drug intervention
537991|NCT00668746|O1|Outcome|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
537992|NCT00668746|E2|Reported Event|No Drug Intervention|A control consisting of no drug intervention
537993|NCT00668746|E1|Reported Event|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
537994|NCT00668733|B3|Baseline|Total|Total of all reporting groups
537995|NCT00668733|B2|Baseline|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
537996|NCT00668733|B1|Baseline|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
537997|NCT00668733|P2|Participant Flow|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
537998|NCT00668733|P1|Participant Flow|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
537999|NCT00668733|O2|Outcome|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
538000|NCT00668733|O1|Outcome|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
538001|NCT00668733|E2|Reported Event|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
538002|NCT00668733|E1|Reported Event|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
538003|NCT00668564|B1|Baseline|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
538004|NCT00668564|P1|Participant Flow|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
538005|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
538006|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
538007|NCT00668564|E1|Reported Event|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
538008|NCT00668525|B4|Baseline|Total|Total of all reporting groups
538009|NCT00668525|B3|Baseline|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538010|NCT00668525|B2|Baseline|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538011|NCT00668525|B1|Baseline|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538012|NCT00668525|P3|Participant Flow|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538013|NCT00668525|P2|Participant Flow|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538014|NCT00668525|P1|Participant Flow|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538015|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538016|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538017|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538018|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538019|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
542657|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
538021|NCT00668525|E3|Reported Event|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538022|NCT00668525|E2|Reported Event|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538023|NCT00668525|E1|Reported Event|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
538024|NCT00668434|B3|Baseline|Total|Total of all reporting groups
538025|NCT00668434|B2|Baseline|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
538026|NCT00668434|B1|Baseline|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
538027|NCT00668434|P2|Participant Flow|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
538028|NCT00668434|P1|Participant Flow|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
538029|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
538030|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
538031|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
538032|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
538033|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
538034|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
538035|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
538036|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
538037|NCT00668434|E2|Reported Event|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
538038|NCT00668434|E1|Reported Event|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
538039|NCT00668395|B4|Baseline|Total|Total of all reporting groups
538040|NCT00668395|B3|Baseline|CYP2B6*6/*6|Slow metabolizer
538041|NCT00668395|B2|Baseline|CYP2B6*1/*6|Intermediate metabolizer
538042|NCT00668395|B1|Baseline|CYP2B6*1/*1|Normal metabolizer
538043|NCT00668395|P3|Participant Flow|CYP2B6*6/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
538044|NCT00668395|P2|Participant Flow|CYP2B6*1/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
538133|NCT00667992|E1|Reported Event|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
538045|NCT00668395|P1|Participant Flow|CYP2B6*1/*1 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
538046|NCT00668395|O3|Outcome|CYP2B6*6/*6|Slow metabolizer
538047|NCT00668395|O2|Outcome|CYP2B6*1/*6|Intermediate metabolizer
538048|NCT00668395|O1|Outcome|CYP2B6*1/*1|Normal metabolizer
538049|NCT00668395|E3|Reported Event|CYP2B6*6/*6|Slow metabolizer
538050|NCT00668395|E2|Reported Event|CYP2B6*1/*6|Intermediate metabolizer
538051|NCT00668395|E1|Reported Event|CYP2B6*1/*1|Normal metabolizer
538052|NCT00668382|B1|Baseline|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
538053|NCT00668382|P1|Participant Flow|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
538054|NCT00668382|O1|Outcome|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
538055|NCT00668382|E1|Reported Event|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
538056|NCT00668317|B1|Baseline|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
538057|NCT00668317|P1|Participant Flow|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
538058|NCT00668317|O1|Outcome|Omeprazole and Ranitidine|Therapy with omeprazole 20 mg twice a day (BD) and Ranitidine 300mg once a day (od) at night (nocte)
538059|NCT00668317|E1|Reported Event|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
538060|NCT00668265|B3|Baseline|Total|Total of all reporting groups
538061|NCT00668265|B2|Baseline|Placebo|Subjects on methadone maintenance receiving placebo while inpatients in a methadone treatment facility Su Casa
538062|NCT00668265|B1|Baseline|Quetiapine|Subjects on MMTP receiving quetiapine
538063|NCT00668265|P2|Participant Flow|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
538064|NCT00668265|P1|Participant Flow|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
538065|NCT00668265|O2|Outcome|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
538066|NCT00668265|O1|Outcome|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
538067|NCT00668265|O2|Outcome|Placebo|
538068|NCT00668265|O1|Outcome|Quetiapine|
538069|NCT00668265|E2|Reported Event|Placebo|Placebo arm for subjects on MMTP in Su Casa Residence
538070|NCT00668265|E1|Reported Event|Quetiapine|Active treatment arm for subjects on MMTP in Su Casa residence
538071|NCT00668200|B1|Baseline|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
538072|NCT00668200|P1|Participant Flow|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
538073|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
538074|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
538075|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
538076|NCT00668200|E1|Reported Event|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
538077|NCT00667992|B3|Baseline|Total|Total of all reporting groups
538078|NCT00667992|B2|Baseline|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
538079|NCT00667992|B1|Baseline|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily, First then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
538134|NCT00667875|B4|Baseline|Total|Total of all reporting groups
538757|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538080|NCT00667992|P2|Participant Flow|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, Wash out, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
538081|NCT00667992|P1|Participant Flow|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily First, Wash out, then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
538082|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538083|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538084|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538085|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538086|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538087|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538088|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538089|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538090|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538091|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
538092|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538093|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538094|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538095|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538096|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538097|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538098|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538099|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538100|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538101|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
538102|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538103|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538104|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538105|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
538106|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538107|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538108|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538109|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538110|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538111|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538112|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538113|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538114|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538115|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
538116|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538117|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538118|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538119|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
538120|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538121|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
538122|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538123|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
538124|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538125|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
538126|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538127|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538128|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
538129|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
538130|NCT00667992|E4|Reported Event|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
538131|NCT00667992|E3|Reported Event|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
538132|NCT00667992|E2|Reported Event|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
539340|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
538135|NCT00667875|B3|Baseline|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
538136|NCT00667875|B2|Baseline|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
538137|NCT00667875|B1|Baseline|1 Placebo|Placebo : placebo
538138|NCT00667875|P3|Participant Flow|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
538139|NCT00667875|P2|Participant Flow|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
538140|NCT00667875|P1|Participant Flow|1 Placebo|Placebo : placebo
538141|NCT00667875|O3|Outcome|Naltrexone:Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
538142|NCT00667875|O2|Outcome|Naltrexone: Placebo Aripiprazole|"Naltrexone~Naltrexone: Naltrexone (25mg or 50 mg per titration schedule): placebo aripiprazole"
538143|NCT00667875|O1|Outcome|Placebo: Placebo|Placebo naltrexone and placebo aripiprazole
538144|NCT00667875|O3|Outcome|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
538145|NCT00667875|O2|Outcome|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
538146|NCT00667875|O1|Outcome|1 Placebo|Placebo : placebo
538147|NCT00667875|O3|Outcome|Naltrexone:Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
538148|NCT00667875|O2|Outcome|Naltrexone: Placebo Aripiprazole|"Naltrexone~Naltrexone: Naltrexone (25mg or 50 mg per titration schedule): placebo aripiprazole"
538149|NCT00667875|O1|Outcome|Placebo: Placebo|Placebo naltrexone and placebo aripiprazole
538150|NCT00667875|O3|Outcome|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
538151|NCT00667875|O2|Outcome|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
538152|NCT00667875|O1|Outcome|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
538153|NCT00667875|E3|Reported Event|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
538154|NCT00667875|E2|Reported Event|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
538155|NCT00667875|E1|Reported Event|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
538156|NCT00667849|B3|Baseline|Total|Total of all reporting groups
538157|NCT00667849|B2|Baseline|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound).~Sham: sham device identical to active device with the exception of administration of ultrasound"
538158|NCT00667849|B1|Baseline|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
538159|NCT00667849|P2|Participant Flow|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: sham device identical to active device with the exception of administration of ultrasound"
538160|NCT00667849|P1|Participant Flow|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
538161|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~sham: sham device identical to active device with the exception of administration of ultrasound"
538162|NCT00667849|O1|Outcome|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
538163|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
538164|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
538165|NCT00667849|O2|Outcome|Sham|Single arm, sham (identical to active device with the exception of administration of ultrasound)
538166|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
538167|NCT00667849|E2|Reported Event|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
538168|NCT00667849|E1|Reported Event|Exogen 4000+|"Single arm, active Exogen 4000+ ultrasound bone healing system~Low-intensity pulsed ultrasound (LIPUS)"
538169|NCT00667810|B5|Baseline|Total|Total of all reporting groups
538170|NCT00667810|B4|Baseline|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538171|NCT00667810|B3|Baseline|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538172|NCT00667810|B2|Baseline|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538173|NCT00667810|B1|Baseline|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538174|NCT00667810|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538175|NCT00667810|P3|Participant Flow|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538176|NCT00667810|P2|Participant Flow|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538267|NCT00667693|B1|Baseline|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
542658|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
538177|NCT00667810|P1|Participant Flow|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by intravenous (IV) infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538178|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538179|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538180|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538181|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538182|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538183|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538184|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538185|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538186|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538187|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538188|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538189|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538190|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538191|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538192|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538193|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538194|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538195|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538196|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538197|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538198|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538199|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538200|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538201|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538202|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538203|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538268|NCT00667693|P2|Participant Flow|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
542659|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
538204|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538205|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538206|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538207|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538208|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the DAD total score, results are presented from a REML)-based MMRM.
538209|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the DAD total score, results are presented from a REML-based MMRM.
538210|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
538211|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
538212|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538213|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538214|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538215|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined
538216|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538217|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538218|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538219|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined to form the Pooled Bapineuzumab group.
538220|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538221|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538222|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538223|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538224|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538225|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538226|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538227|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538228|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538229|NCT00667810|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538230|NCT00667810|E3|Reported Event|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538231|NCT00667810|E2|Reported Event|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538232|NCT00667810|E1|Reported Event|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
538233|NCT00667745|B3|Baseline|Total|Total of all reporting groups
538269|NCT00667693|P1|Participant Flow|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
542660|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
538234|NCT00667745|B2|Baseline|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538235|NCT00667745|B1|Baseline|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538236|NCT00667745|P2|Participant Flow|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538237|NCT00667745|P1|Participant Flow|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538238|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538239|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed. Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538240|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538241|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed. Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538242|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538243|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538244|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538270|NCT00667693|O2|Outcome|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
538271|NCT00667693|O1|Outcome|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
538272|NCT00667693|E2|Reported Event|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
538245|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538246|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538247|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538248|NCT00667745|E2|Reported Event|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538249|NCT00667745|E1|Reported Event|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
538250|NCT00667732|B3|Baseline|Total|Total of all reporting groups
538251|NCT00667732|B2|Baseline|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
538252|NCT00667732|B1|Baseline|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
538253|NCT00667732|P3|Participant Flow|Placebo Group|"After run-in participants were randomized to placebo.~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide instead of placebo"
538254|NCT00667732|P2|Participant Flow|Exenatide Group|"After run-in participants were randomized to exenatide.~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide"
538255|NCT00667732|P1|Participant Flow|Run-In Group|"All participants took exenatide twice daily in addition to their Metformin dose.~A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time."
538256|NCT00667732|O2|Outcome|Placebo Group|
538257|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
538258|NCT00667732|O2|Outcome|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
538259|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
538260|NCT00667732|E5|Reported Event|Exenatide Open-Label (Previous Placebo)|Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
538261|NCT00667732|E4|Reported Event|Exenatide Open-Label (Previous Exenatide)|Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
538262|NCT00667732|E3|Reported Event|Placebo Randomization Period|After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
538263|NCT00667732|E2|Reported Event|Exenatide Randomization Group|After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
538264|NCT00667732|E1|Reported Event|Run-In Group|All participants took exenatide twice daily in addition to their Metformin dose.
538265|NCT00667693|B3|Baseline|Total|Total of all reporting groups
538266|NCT00667693|B2|Baseline|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
538274|NCT00667615|B1|Baseline|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
538275|NCT00667615|P1|Participant Flow|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
538276|NCT00667615|O1|Outcome|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
538277|NCT00667615|O1|Outcome|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
538278|NCT00667615|E1|Reported Event|Relapsed or Refractory Diffuse Large B-cell Lymphoma|Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks.
538279|NCT00667602|B4|Baseline|Total|Total of all reporting groups
538280|NCT00667602|B3|Baseline|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538281|NCT00667602|B2|Baseline|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538282|NCT00667602|B1|Baseline|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538283|NCT00667602|P3|Participant Flow|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538284|NCT00667602|P2|Participant Flow|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538285|NCT00667602|P1|Participant Flow|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538286|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538287|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538288|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538289|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538290|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538291|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538292|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538293|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538294|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538295|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538296|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538297|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538298|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538299|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538300|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538301|NCT00667602|O3|Outcome|MenC(1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538302|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538303|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538304|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538305|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538306|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538307|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538308|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538309|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538310|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538311|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538312|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538313|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months.
538314|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538315|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538316|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538317|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538318|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538319|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538320|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538321|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538322|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538323|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538324|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538325|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538326|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538327|NCT00667602|E3|Reported Event|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538328|NCT00667602|E2|Reported Event|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538329|NCT00667602|E1|Reported Event|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
538330|NCT00667589|B5|Baseline|Total|Total of all reporting groups
538331|NCT00667589|B4|Baseline|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
538332|NCT00667589|B3|Baseline|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
538333|NCT00667589|B2|Baseline|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
538334|NCT00667589|B1|Baseline|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
538335|NCT00667589|P4|Participant Flow|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
538336|NCT00667589|P3|Participant Flow|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
538337|NCT00667589|P2|Participant Flow|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
538338|NCT00667589|P1|Participant Flow|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
538339|NCT00667589|O3|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
538340|NCT00667589|O2|Outcome|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
538341|NCT00667589|O1|Outcome|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
538342|NCT00667589|O1|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
538343|NCT00667589|E4|Reported Event|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
538344|NCT00667589|E3|Reported Event|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
538345|NCT00667589|E2|Reported Event|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
538346|NCT00667589|E1|Reported Event|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
538347|NCT00667576|B6|Baseline|Total|Total of all reporting groups
538348|NCT00667576|B5|Baseline|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538349|NCT00667576|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538350|NCT00667576|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538351|NCT00667576|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538352|NCT00667576|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538353|NCT00667576|P5|Participant Flow|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538354|NCT00667576|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538358|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538359|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538360|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538361|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538362|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538363|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538364|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538365|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538366|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538367|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538368|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538369|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538370|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538371|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538372|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538373|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538374|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538375|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538376|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538377|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538378|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538379|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538380|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538381|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538382|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538383|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538384|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538385|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538386|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538387|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538388|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538389|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538390|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538391|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538392|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538393|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538394|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538395|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538396|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538397|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538398|NCT00667576|E5|Reported Event|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
538399|NCT00667576|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
538400|NCT00667576|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
538401|NCT00667576|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
538402|NCT00667576|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
538403|NCT00667563|B1|Baseline|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538416|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
538404|NCT00667563|P1|Participant Flow|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538405|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538406|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538407|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538408|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538409|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538410|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538411|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538412|NCT00667563|E1|Reported Event|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
538413|NCT00667511|B1|Baseline|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period."
538414|NCT00667511|P1|Participant Flow|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period.~In this prospective, two treatment, cross-over study, 58 End Stage Renal Disease patients >18 years of age who were currently stable on home DHD were enrolled. Enrolled patients performed Intervention 1 as the first phase of the cross-over study. Fifty-one patients completed Intervention 1 and seven patients dropped out. Forty-three patients completed the training/transition period and performed Intervention 2 as the second phase of the cross-over study. Thirty-nine patients completed Intervention 2 and four patients dropped out."
538415|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
538417|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
538418|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
538419|NCT00667511|E2|Reported Event|Nocturnal Home Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
538420|NCT00667511|E1|Reported Event|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
538421|NCT00667459|B3|Baseline|Total|Total of all reporting groups
538422|NCT00667459|B2|Baseline|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538423|NCT00667459|B1|Baseline|Investigational|PRESTIGE® LP Cervical Disc
538424|NCT00667459|P2|Participant Flow|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876)
538425|NCT00667459|P1|Participant Flow|Investigational|PRESTIGE® LP Cervical Disc
538426|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538427|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538428|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538429|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538430|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538431|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538432|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538433|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538434|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538435|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538436|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538437|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538438|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538439|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538440|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538441|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538442|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538443|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538444|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538445|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538446|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538447|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538448|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538449|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538450|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538451|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538452|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538453|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538454|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538455|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538456|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538457|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538458|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538459|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538460|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538461|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
538462|NCT00667459|E2|Reported Event|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
538463|NCT00667459|E1|Reported Event|Investigational|PRESTIGE® LP Cervical Disc
538464|NCT00667446|B3|Baseline|Total|Total of all reporting groups
538465|NCT00667446|B2|Baseline|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538466|NCT00667446|B1|Baseline|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538467|NCT00667446|P2|Participant Flow|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
538468|NCT00667446|P1|Participant Flow|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
538469|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538470|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538471|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538472|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538473|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538474|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538475|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538476|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538477|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538478|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538479|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538480|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538481|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538482|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538483|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538484|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538485|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538486|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538487|NCT00667446|E2|Reported Event|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
538488|NCT00667446|E1|Reported Event|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
538489|NCT00667420|B1|Baseline|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
538490|NCT00667420|P1|Participant Flow|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
538491|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
538492|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
538493|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
538494|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
538495|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
538496|NCT00667420|E1|Reported Event|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
538497|NCT00667394|B3|Baseline|Total|Total of all reporting groups
538498|NCT00667394|B2|Baseline|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
538499|NCT00667394|B1|Baseline|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
538500|NCT00667394|P2|Participant Flow|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
538501|NCT00667394|P1|Participant Flow|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
538502|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
538503|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
538504|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
538505|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
538584|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538506|NCT00667394|E2|Reported Event|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
538507|NCT00667394|E1|Reported Event|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
538508|NCT00667381|B3|Baseline|Total|Total of all reporting groups
538509|NCT00667381|B2|Baseline|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538510|NCT00667381|B1|Baseline|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538511|NCT00667381|P2|Participant Flow|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538512|NCT00667381|P1|Participant Flow|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538513|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538514|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538515|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538516|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538517|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538518|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538519|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538520|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538521|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538522|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538523|NCT00667381|E2|Reported Event|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
538524|NCT00667381|E1|Reported Event|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
538525|NCT00667368|B3|Baseline|Total|Total of all reporting groups
538526|NCT00667368|B2|Baseline|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
538527|NCT00667368|B1|Baseline|Control|Bi-monthly testing for BV without treatment.
538528|NCT00667368|P2|Participant Flow|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
538529|NCT00667368|P1|Participant Flow|Control|Bi-monthly testing for BV without treatment.
538530|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
538531|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
538532|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
538533|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
538534|NCT00667368|E2|Reported Event|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
538535|NCT00667368|E1|Reported Event|Control|Bi-monthly testing for BV without treatment.
538536|NCT00667355|B1|Baseline|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538537|NCT00667355|P1|Participant Flow|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538538|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538539|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538540|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538541|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538542|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538543|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538544|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538545|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538546|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538547|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538548|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538549|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538550|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538551|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538552|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538553|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538554|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538555|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538556|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538557|NCT00667355|E1|Reported Event|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
538558|NCT00667342|B4|Baseline|Total|Total of all reporting groups
538559|NCT00667342|B3|Baseline|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538560|NCT00667342|B2|Baseline|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
538561|NCT00667342|B1|Baseline|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538562|NCT00667342|P3|Participant Flow|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538563|NCT00667342|P2|Participant Flow|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
538564|NCT00667342|P1|Participant Flow|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538565|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
538566|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
538567|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
538568|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
538569|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
538570|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
538571|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
538572|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
538573|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
538574|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
538575|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
538576|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
538577|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
538578|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
538579|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
538580|NCT00667342|O1|Outcome|All Participants|Thirty-two participants with osteosarcoma were evaluated in this study. The analysis for this outcome measure included 23 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 8 Stratum C participants who had metastatic tumors.
538581|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
538582|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
538583|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
542661|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
538585|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538586|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538587|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538588|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538589|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538590|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538591|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538592|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants were included in this analysis
538593|NCT00667342|O1|Outcome|All Participants|All the 42 evaluable participants in this study had osteosarcoma, of which 22 had events and 20 had no event.
538594|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538595|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538596|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538597|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538598|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538599|NCT00667342|E2|Reported Event|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
538600|NCT00667342|E1|Reported Event|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
538601|NCT00667277|B1|Baseline|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
538602|NCT00667277|P1|Participant Flow|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
538603|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
538604|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
538605|NCT00667277|E1|Reported Event|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
538606|NCT00667251|B3|Baseline|Total|Total of all reporting groups
538607|NCT00667251|B2|Baseline|Trastuzumab|
538608|NCT00667251|B1|Baseline|Lapatinib|
538609|NCT00667251|P2|Participant Flow|Trastuzumab|Trastuzumab ng- IV weekly (loading dose 4 mg/kg, subsequent doses 2 mg/kg) Paclitaxel - 80 mg/m2 IV weekly (days 1, 8 and 15 of a 4-week cycle). or Trastuzumab - IV weekly (loading dose 8 mg/kg, subsequent doses 6 mg/kg) Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3 week cycle) Followed by: Trastuzumab - 6 mg/kg IV q 3 weekly until disease progression.
538610|NCT00667251|P1|Participant Flow|Lapatinib|Lapatinib - 1250 mg po daily Taxane based chemotherapy: Paclitaxel - 80 mg/m2 IV q weekly (days 1, 8 and 15 of a 4-week cycle) or Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3-week cycle) plus G-CSF - according to institutional standards. Followed by: Lapatinib - 1500 mg po daily until disease progression.
538611|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538612|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538613|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538614|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538615|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538616|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538617|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538618|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538619|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538620|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538621|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538622|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538623|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538624|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538625|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538626|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538627|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538628|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538629|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
538630|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
538631|NCT00667251|E2|Reported Event|Trastuzumab|Plus taxane based chemotherapy.
538632|NCT00667251|E1|Reported Event|Lapatinib|Plus taxane based chemotherapy
538633|NCT00667225|B3|Baseline|Total|Total of all reporting groups
542662|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
538634|NCT00667225|B2|Baseline|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538635|NCT00667225|B1|Baseline|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538636|NCT00667225|P2|Participant Flow|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538637|NCT00667225|P1|Participant Flow|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538638|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538639|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538640|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538641|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538642|NCT00667225|E2|Reported Event|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538643|NCT00667225|E1|Reported Event|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
538644|NCT00667186|B3|Baseline|Total|Total of all reporting groups
538645|NCT00667186|B2|Baseline|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538646|NCT00667186|B1|Baseline|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538647|NCT00667186|P2|Participant Flow|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538648|NCT00667186|P1|Participant Flow|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538649|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538650|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538725|NCT00666926|P15|Participant Flow|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538651|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538652|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538653|NCT00667186|E2|Reported Event|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538654|NCT00667186|E1|Reported Event|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
538655|NCT00667095|B3|Baseline|Total|Total of all reporting groups
538656|NCT00667095|B2|Baseline|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538657|NCT00667095|B1|Baseline|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538658|NCT00667095|P2|Participant Flow|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538659|NCT00667095|P1|Participant Flow|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538660|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538661|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538662|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538663|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538664|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538665|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538666|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538667|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538668|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538669|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538670|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538726|NCT00666926|P14|Participant Flow|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538727|NCT00666926|P13|Participant Flow|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538758|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538671|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538672|NCT00667095|E2|Reported Event|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538673|NCT00667095|E1|Reported Event|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
538674|NCT00666978|B3|Baseline|Total|Total of all reporting groups
538675|NCT00666978|B2|Baseline|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
538676|NCT00666978|B1|Baseline|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
538677|NCT00666978|P2|Participant Flow|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
538678|NCT00666978|P1|Participant Flow|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
538679|NCT00666978|O1|Outcome|All Study Participants|All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
538680|NCT00666978|O1|Outcome|Bupropion Arm|270 African American adults received bupropion (150mg bid)for 7 weeks in addition to health education counseling.
538681|NCT00666978|O1|Outcome|All Study Participants|All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
538682|NCT00666978|O2|Outcome|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
538683|NCT00666978|O1|Outcome|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
538684|NCT00666978|E2|Reported Event|Placebo Arm|270 African American adults received placebo for 7 weeks in addition to health education counseling.
538685|NCT00666978|E1|Reported Event|Bupropion Arm|270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
538686|NCT00666965|B5|Baseline|Total|Total of all reporting groups
538687|NCT00666965|B4|Baseline|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538688|NCT00666965|B3|Baseline|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538689|NCT00666965|B2|Baseline|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538690|NCT00666965|B1|Baseline|Placebo|placebo transdermal patch
538691|NCT00666965|P4|Participant Flow|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538692|NCT00666965|P3|Participant Flow|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538693|NCT00666965|P2|Participant Flow|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538694|NCT00666965|P1|Participant Flow|Placebo|placebo transdermal patch
538695|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538696|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538697|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538698|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
538699|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538700|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538701|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538702|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
538703|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538704|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538705|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538706|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
538707|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538708|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538709|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538710|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
538711|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538712|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538713|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538714|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
538715|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538716|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538717|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538718|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
538719|NCT00666965|E4|Reported Event|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
538720|NCT00666965|E3|Reported Event|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
538721|NCT00666965|E2|Reported Event|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
538722|NCT00666965|E1|Reported Event|Placebo|placebo transdermal patch
538723|NCT00666926|B1|Baseline|Entire Study Population|PF-00562271 dose escalation administered as 5 mg PO BID up to 150 mg PO BID or 125 mg PO QD up to 225 mg PO QD. Participants in the PF-00562271125 mg BID US E1 cohort administered MDZ 2 mg/mL as a single dose on C1.D1 and C1.D21 prior to PF-00562271 dosing.
538724|NCT00666926|P16|Participant Flow|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
542663|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
538728|NCT00666926|P12|Participant Flow|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 (C1.D21) simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
538729|NCT00666926|P11|Participant Flow|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538730|NCT00666926|P10|Participant Flow|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
538731|NCT00666926|P9|Participant Flow|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538732|NCT00666926|P8|Participant Flow|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
538733|NCT00666926|P7|Participant Flow|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538734|NCT00666926|P6|Participant Flow|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538735|NCT00666926|P5|Participant Flow|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538736|NCT00666926|P4|Participant Flow|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538737|NCT00666926|P3|Participant Flow|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538738|NCT00666926|P2|Participant Flow|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538739|NCT00666926|P1|Participant Flow|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538740|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538741|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538742|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538743|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538744|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538745|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538746|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538747|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538748|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
538749|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538750|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538751|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538752|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538753|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538754|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538755|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538756|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
539341|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
538759|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538760|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538761|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538762|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538763|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538764|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
538765|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538766|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538767|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538768|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538769|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538770|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538771|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538772|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538773|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538774|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538775|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538776|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538777|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538778|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538779|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538780|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
538781|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538782|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538783|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538784|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538785|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538786|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538787|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538788|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538789|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
539342|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
538790|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538791|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538792|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538793|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538794|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538795|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538796|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
538797|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538798|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538799|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538800|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538801|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538802|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538803|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538804|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538805|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538806|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538807|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538808|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538809|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538810|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538811|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538812|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
538813|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538814|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538815|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538816|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538817|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538818|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538819|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538835|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
539343|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
538820|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538821|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538822|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538823|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538824|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538825|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538826|NCT00666926|O14|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538827|NCT00666926|O13|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538828|NCT00666926|O12|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538829|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538830|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538831|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538832|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538833|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538834|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538836|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538837|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538838|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538839|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538840|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538841|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538842|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538843|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538844|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538845|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538846|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538847|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538848|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538849|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538850|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538851|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538852|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538853|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538854|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538855|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538856|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538857|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538858|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538859|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538860|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538861|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538862|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538863|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538864|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538865|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538866|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538867|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538868|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538869|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538870|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538871|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
542664|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
538872|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538873|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538874|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538875|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538876|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538877|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538878|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538879|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538880|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538881|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538882|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538883|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538884|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538885|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538886|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538887|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538888|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538889|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538890|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538891|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538892|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538893|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538894|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538895|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538896|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538897|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538898|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538899|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538900|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538901|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538902|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538903|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538936|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538937|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
542665|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
538904|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538905|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538906|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538907|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538908|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538909|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538910|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538911|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538912|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538913|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538914|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538915|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538916|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538917|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538918|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538919|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538920|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538921|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538922|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538923|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538924|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538925|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538926|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538927|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538928|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538929|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538930|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538931|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538932|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538933|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538934|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538935|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538938|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538939|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538940|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538941|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538942|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538943|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538944|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538945|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538946|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538947|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
538948|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538949|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538950|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538951|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538952|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
538953|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538954|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538955|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538956|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538957|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538958|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538959|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538960|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538961|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538962|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538963|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538964|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538965|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538966|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538967|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538968|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538999|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
542666|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
538969|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538970|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538971|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538972|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538973|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538974|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538975|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538976|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538977|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538978|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538979|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538980|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
538981|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538982|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
538983|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
538984|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
538985|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
538986|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
538987|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
538988|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
538989|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
538990|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
538991|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
538992|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
538993|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
538994|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
538995|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
538996|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
538997|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
538998|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
539000|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
539001|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
539002|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
539003|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
539004|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
539005|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
539006|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
539007|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
539008|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
539009|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
539010|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
539011|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
539012|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
539013|NCT00666926|E16|Reported Event|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
539014|NCT00666926|E15|Reported Event|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
539015|NCT00666926|E14|Reported Event|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
539016|NCT00666926|E13|Reported Event|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
539017|NCT00666926|E12|Reported Event|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
539018|NCT00666926|E11|Reported Event|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
539019|NCT00666926|E10|Reported Event|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
539020|NCT00666926|E9|Reported Event|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
539021|NCT00666926|E8|Reported Event|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
539022|NCT00666926|E7|Reported Event|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
539023|NCT00666926|E6|Reported Event|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
539024|NCT00666926|E5|Reported Event|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
539025|NCT00666926|E4|Reported Event|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
539026|NCT00666926|E3|Reported Event|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
539027|NCT00666926|E2|Reported Event|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
539028|NCT00666926|E1|Reported Event|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
539029|NCT00666848|B4|Baseline|Total|Total of all reporting groups
542667|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
539030|NCT00666848|B3|Baseline|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
539031|NCT00666848|B2|Baseline|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
539032|NCT00666848|B1|Baseline|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
539033|NCT00666848|P3|Participant Flow|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
539034|NCT00666848|P2|Participant Flow|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
539035|NCT00666848|P1|Participant Flow|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
539036|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
539037|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
539038|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
539039|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
539040|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
539041|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
539042|NCT00666848|E3|Reported Event|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
539043|NCT00666848|E2|Reported Event|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
539044|NCT00666848|E1|Reported Event|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
539045|NCT00666835|B3|Baseline|Total|Total of all reporting groups
539046|NCT00666835|B2|Baseline|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag intravenously in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539047|NCT00666835|B1|Baseline|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539048|NCT00666835|P2|Participant Flow|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated intravenously with ERYPO®, Janssen-Cilag in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539049|NCT00666835|P1|Participant Flow|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to epoetin alfa HX575 Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539050|NCT00666835|O2|Outcome|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated intravenously with ERYPO® Janssen-Cilag in pre-filled syringes (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539051|NCT00666835|O1|Outcome|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539052|NCT00666835|O2|Outcome|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539053|NCT00666835|O1|Outcome|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1. Treatment was done intravenously (solution for injection i.v.) in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539087|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539054|NCT00666835|E2|Reported Event|ERYPO®, Janssen-Cilag|Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539055|NCT00666835|E1|Reported Event|HX575 Epoetin Alfa Hexal AG|Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1 to be intravenously (solution for injection i.v.) treated with HX575 in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28.
539056|NCT00666757|B3|Baseline|Total|Total of all reporting groups
539057|NCT00666757|B2|Baseline|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539058|NCT00666757|B1|Baseline|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539059|NCT00666757|P2|Participant Flow|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539060|NCT00666757|P1|Participant Flow|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539061|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539062|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539063|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539064|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539065|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539066|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539067|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539068|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539069|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539070|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539071|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539072|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539073|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539074|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539075|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539076|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539077|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539078|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539079|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539080|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539081|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539082|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539083|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539084|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539085|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539086|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539088|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
542668|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
539089|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539090|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539091|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539092|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539093|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539094|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539095|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539096|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539097|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539098|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539099|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539100|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539101|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539102|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539103|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539104|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539105|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539106|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539107|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539108|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539109|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
539110|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
539111|NCT00666757|E5|Reported Event|Sertraline|50-200 mg orally daily for 12 weeks
539112|NCT00666757|E4|Reported Event|Paroxetine|20-50 mg orally daily for 12 weeks
539113|NCT00666757|E3|Reported Event|Fluoxetine|20-80 mg orally daily for 12 weeks
539114|NCT00666757|E2|Reported Event|Citalopram|20-40 mg orally daily for 12 weeks
539115|NCT00666757|E1|Reported Event|Duloxetine|30-120 mg orally daily for 12 weeks
539116|NCT00666718|B3|Baseline|Total|Total of all reporting groups
539117|NCT00666718|B2|Baseline|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
539118|NCT00666718|B1|Baseline|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
539119|NCT00666718|P2|Participant Flow|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
539120|NCT00666718|P1|Participant Flow|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
539121|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539122|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539123|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539124|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539125|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539126|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539127|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539128|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539129|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539130|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539131|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539132|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539133|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539134|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539135|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539136|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539137|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539138|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539139|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539140|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539141|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
539142|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
539143|NCT00666718|E2|Reported Event|Lispro/Metformin|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
539144|NCT00666718|E1|Reported Event|Glargine/Lispro|Glargine plus Insulin Lispro (2-3 injections) plus metformin
539145|NCT00666705|B1|Baseline|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 mg every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
539146|NCT00666705|P1|Participant Flow|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
539147|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
539148|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
539149|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
539150|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
539151|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
539152|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
539153|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
539154|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
539155|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
539156|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
539157|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
539158|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
539159|NCT00666705|E3|Reported Event|Raltegravir|400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
539160|NCT00666705|E2|Reported Event|Maraviroc + Raltegravir|On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
539161|NCT00666705|E1|Reported Event|Maraviroc|300 milligrams (mg) every 12 hours on Study Days 6-11
539162|NCT00666679|B3|Baseline|Total|Total of all reporting groups
539163|NCT00666679|B2|Baseline|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
539164|NCT00666679|B1|Baseline|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
539165|NCT00666679|P2|Participant Flow|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
539166|NCT00666679|P1|Participant Flow|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
539167|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539168|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539169|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539170|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539171|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539172|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539173|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539174|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539175|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539176|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539177|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539178|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539179|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539180|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539181|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539182|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539183|NCT00666679|E2|Reported Event|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
539184|NCT00666679|E1|Reported Event|Montelukast + Mometasone|Inhaled montelukast 1 mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
539185|NCT00666666|B1|Baseline|AT101 (R-(-)-Gossypol Acetic Acid)|
539186|NCT00666666|P1|Participant Flow|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
539187|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
539188|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
539189|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
539344|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539190|NCT00666666|E1|Reported Event|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
539191|NCT00666588|B5|Baseline|Total|Total of all reporting groups
539192|NCT00666588|B4|Baseline|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539193|NCT00666588|B3|Baseline|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539194|NCT00666588|B2|Baseline|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539195|NCT00666588|B1|Baseline|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539196|NCT00666588|P4|Participant Flow|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539197|NCT00666588|P3|Participant Flow|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539198|NCT00666588|P2|Participant Flow|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539199|NCT00666588|P1|Participant Flow|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539230|NCT00666562|B2|Baseline|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539200|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539201|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539202|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539203|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539204|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539205|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539206|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539207|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539208|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539209|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539210|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539211|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539212|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539213|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539214|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539215|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539216|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539217|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539218|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539231|NCT00666562|B1|Baseline|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539271|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539219|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539220|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539221|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539222|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539223|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539224|NCT00666588|E4|Reported Event|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539225|NCT00666588|E3|Reported Event|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539226|NCT00666588|E2|Reported Event|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
539227|NCT00666588|E1|Reported Event|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
539228|NCT00666562|B4|Baseline|Total|Total of all reporting groups
539229|NCT00666562|B3|Baseline|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539337|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539232|NCT00666562|P3|Participant Flow|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539233|NCT00666562|P2|Participant Flow|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539234|NCT00666562|P1|Participant Flow|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539235|NCT00666562|O4|Outcome|7/7 Genotype|Genotype of the UGT in EGCG
539236|NCT00666562|O3|Outcome|6/7 Genotype|Genotype of the UGT in EGCG
539237|NCT00666562|O2|Outcome|6/6 Genotype|Genotype of the UGT in EGCG
539238|NCT00666562|O1|Outcome|5/6 Genotype|Genotype of the UGT in EGCG
539239|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539240|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539241|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539242|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539243|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539244|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539245|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539246|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539247|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539248|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539249|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539250|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539251|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
542669|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
539252|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539253|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539254|NCT00666562|O3|Outcome|Alanine/Alanine|A to A transition in the COMT gene
539255|NCT00666562|O2|Outcome|Alanine/Glycine|A to G transition in the COMT gene
539256|NCT00666562|O1|Outcome|Glycine/Glycine|G to G transition in the COMT gene
539257|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539258|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539259|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539260|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539261|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539262|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539263|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539264|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539265|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539266|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539267|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539268|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539269|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539270|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539338|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539272|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539273|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539274|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539275|NCT00666562|E3|Reported Event|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539276|NCT00666562|E2|Reported Event|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539277|NCT00666562|E1|Reported Event|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
539278|NCT00666536|B3|Baseline|Total|Total of all reporting groups
539279|NCT00666536|B2|Baseline|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539280|NCT00666536|B1|Baseline|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539281|NCT00666536|P2|Participant Flow|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539282|NCT00666536|P1|Participant Flow|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539283|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539284|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539285|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539286|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539287|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539288|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539289|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539290|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539339|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
542670|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
539291|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539292|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539293|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539294|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539295|NCT00666536|E2|Reported Event|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539296|NCT00666536|E1|Reported Event|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
539297|NCT00666458|B3|Baseline|Total|Total of all reporting groups
539298|NCT00666458|B2|Baseline|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
539299|NCT00666458|B1|Baseline|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
539300|NCT00666458|P2|Participant Flow|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
539301|NCT00666458|P1|Participant Flow|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
539302|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
539303|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
539304|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
539305|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
539306|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
539307|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
539308|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
539309|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
539310|NCT00666458|E2|Reported Event|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
539311|NCT00666458|E1|Reported Event|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
539312|NCT00666406|B1|Baseline|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
539313|NCT00666406|P2|Participant Flow|Recombinate rAHF Then Advate rAHF-PFM|"First infusion - Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight~Second infusion - Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight"
539314|NCT00666406|P1|Participant Flow|Advate rAHF-PFM Then Recombinate rAHF|"First infusion - Advate Antihemophilic Factor (Recombinant)–Plasma/Albumin Free Method (rAHF-PFM): Infusion of 50 +/- 5 IU/kg bodyweight~Second infusion - Recombinate Antihemophilic Factor (Recombinant) (rAHF): Infusion of 50 +/- 5 IU/kg bodyweight"
539315|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539316|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539317|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539318|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539319|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539320|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539321|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539322|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539323|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539324|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539325|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539326|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539327|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539328|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539329|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539330|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539331|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539332|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539333|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539334|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539335|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539336|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539345|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539346|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539347|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539348|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539349|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539350|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539351|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539352|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539353|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539354|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539355|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539356|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539357|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539358|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539359|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539360|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539361|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539362|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539363|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539364|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539365|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539366|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539367|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539368|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539369|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539370|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539371|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539372|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539373|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539374|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539375|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539376|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539377|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539378|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539379|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539380|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539381|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539382|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539383|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539384|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539385|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
539386|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
539387|NCT00666406|E1|Reported Event|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
539388|NCT00666328|B1|Baseline|Clevidipine|"mITT (Modified Intent To Treat) Population (n=33): This population is the primary population for the efficacy analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
539389|NCT00666328|P1|Participant Flow|Clevidipine|Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.
539390|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
539391|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
542671|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
539392|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
539393|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours
539394|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
539395|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
539396|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for 30 minutes to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
539397|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
539398|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
539399|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
539400|NCT00666328|E1|Reported Event|Clevidipine|"Safety Population (n=35): This population is the primary population for the safety analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
539401|NCT00666276|B1|Baseline|Linezolid|Participants who have been treated with Linezolid.
539402|NCT00666276|P1|Participant Flow|Linezolid|Participants who have been treated with Linezolid.
539403|NCT00666276|O2|Outcome|Linezolid-with Non-drug Therapies|Participants with Non-drug therapies who have been treated with Linezolid.
539404|NCT00666276|O1|Outcome|Linezolid-without Non-drug Therapies|Participants without Non-drug therapies who have been treated with Linezolid.
539405|NCT00666276|O2|Outcome|Linezolid-with Concomitant Drugs|Participants with Concomitant drugs who have been treated with Linezolid.
539406|NCT00666276|O1|Outcome|Linezolid-without Concomitant Drugs|Participants without Concomitant drugs who have been treated with Linezolid.
539407|NCT00666276|O2|Outcome|Linezolid -Less Than 40kg|Participants less than 40kg who have been treated with Linezolid.
539408|NCT00666276|O1|Outcome|Linezolid -Over 40kg|Participants over 40kg who have been treated with Linezolid.
539409|NCT00666276|O3|Outcome|Linezolid-oral From Injection|Participants with who have been treated with Linezolid by orally from injection .
539410|NCT00666276|O2|Outcome|Linezolid-injection|Participants with who have been treated with Linezolid by injection.
539411|NCT00666276|O1|Outcome|Linezolid-oral|Participants with who have been orally treated with Linezolid.
539412|NCT00666276|O2|Outcome|Linezolid-administrated Less Than 15 Days|Participants with who have been treated with Linezolid.with Duration of drug administration less than 15 days
539413|NCT00666276|O1|Outcome|Linezolid-administrated Over 15 Days|Participants who have been treated with Linezolid.with Duration of drug administration over 15 days
539414|NCT00666276|O2|Outcome|Linezolid- With Renal Dysfunctions|Participants with Renal dysfunctions who have been treated with Linezolid.
539415|NCT00666276|O1|Outcome|Linezolid Without Renal Dysfunctions|Participants without Renal dysfunctions who have been treated with Linezolid.
539416|NCT00666276|O2|Outcome|Linezolid- With Hepatic Dysfunctions|Participants with Hepatic dysfunctions who have been treated with Linezolid.
539417|NCT00666276|O1|Outcome|Linezolid-without Hepatic Dysfunctions|Participants with or without Hepatic dysfunctions who have been treated with Linezolid.
539418|NCT00666276|O2|Outcome|Linezolid-less Than 65|Participants with less than 65 years old who have been treated with Linezolid.
539419|NCT00666276|O1|Outcome|Linezolid-over 65|Participants with over 65 years old who have been treated with Linezolid.
539420|NCT00666276|O2|Outcome|Linezolid-female|Female participants who have been treated with Linezolid.
539421|NCT00666276|O1|Outcome|Linezolid-male|Male participants who have been treated with Linezolid.
539422|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
539423|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
539424|NCT00666276|E1|Reported Event|Linezolid|Participants who have been treated with Linezolid.
539425|NCT00666263|B1|Baseline|All Study Participants|"Each participant was to complete 5 study parts (3 stabilization phases of open label treatment with IGIV, 10%, and 1 cross-over period each of double-blind treatment with IGIV, 10% and placebo according to a randomized sequence). Each study part lasted 12 weeks and comprised 3, 4 or 6 infusion cycles depending on treatment interval.~Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) for all participants Study Part 2: Participants were randomized to 1 of 2 sequences of double-blind treatment (either: IGIV, 10% or placebo) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Participants were crossed-over to second sequence of double-blind treatment (IGIV, 10% or placebo) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)"
539426|NCT00666263|P2|Participant Flow|Placebo Then IGIV, 10% (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
539427|NCT00666263|P1|Participant Flow|IGIV, 10% Then Placebo (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
539428|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539429|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539430|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539431|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539432|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539534|NCT00666263|O2|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539535|NCT00666263|O1|Outcome|End of Stabilization 1|(IGIV, 10%)
539591|NCT00666211|P2|Participant Flow|Opioid Titration|Pain will be Monitored and Medication Titrated
539433|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539434|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539435|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539436|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539437|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539438|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539439|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539440|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539441|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539523|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539524|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
542672|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
539442|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539443|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539444|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539445|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539446|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539447|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539448|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539449|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539450|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539525|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539526|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539527|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539528|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539529|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539451|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539452|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539453|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539454|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539455|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539456|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539457|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539458|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539459|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539530|NCT00666263|O6|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539531|NCT00666263|O5|Outcome|End of Stabilization 3|(IGIV, 10%)
542673|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
539460|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539461|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539462|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539463|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539464|NCT00666263|O4|Outcome|No Deterioration After IGIV, 10% or Placebo|Participants with no deterioration in GNDS scores after IGIV, 10% or Placebo
539465|NCT00666263|O3|Outcome|Deterioration After IGIV, 10%, But Not Placebo|Participants with deterioration in GNDS scores after IGIV, 10%, but not Placebo
539466|NCT00666263|O2|Outcome|Deterioration After Placebo, But Not IGIV, 10%|Participants with deterioration in GNDS scores after Placebo, but not IGIV, 10%
539467|NCT00666263|O1|Outcome|Deterioration After IGIV, 10% and Placebo|Participants with deterioration in GNDS scores after IGIV, 10% and placebo
539468|NCT00666263|O4|Outcome|No Decline During Placebo and IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
539469|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
539470|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following the placebo, but not after IGIV, 10%
539471|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, but not after the placebo
539472|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539473|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
539474|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539475|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539476|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539477|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539478|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539479|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539480|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539532|NCT00666263|O4|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539533|NCT00666263|O3|Outcome|End of Stabilization 2|(IGIV, 10%)
539481|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539482|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539483|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539484|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
539485|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539486|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539487|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539488|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539489|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539490|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539491|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539492|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539493|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539494|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539495|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
539496|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539497|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539498|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539499|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539500|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539501|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539502|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539503|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539504|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539505|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539506|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
539507|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539508|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539509|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539510|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539511|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539512|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539513|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539514|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539515|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539516|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539517|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
539518|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539519|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539520|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539521|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539522|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539536|NCT00666263|O4|Outcome|No Accelerated Switch During IGIV, 10% or Placebo|Participants who did not require a switch to open label IGIV, 10% when receiving IGIV, 10%, or placebo
539537|NCT00666263|O3|Outcome|Accelerated Switch During IGIV, 10%, But Not Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, but not during placebo
539538|NCT00666263|O2|Outcome|Accelerated Switch During Placebo, But Not IGIV, 10%|Participants who required a switch to open label IGIV, 10% when receiving the placebo, but not during IGIV, 10%
539539|NCT00666263|O1|Outcome|Accelerated Switch During IGIV, 10% and Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, and placebo
539540|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539541|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539542|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539543|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539544|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539545|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
539546|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539547|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539548|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539549|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539550|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539551|NCT00666263|O4|Outcome|No Decline During Placebo or IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
539552|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
539553|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after IGIV, 10%
539554|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, but not after the placebo
539555|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539556|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539557|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539558|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
539559|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
539560|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
539561|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
539562|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
539563|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
539564|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
539565|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
539566|NCT00666263|E2|Reported Event|Placebo|0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)
539567|NCT00666263|E1|Reported Event|IGIV, 10%|Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)
539568|NCT00666224|B3|Baseline|Total|Total of all reporting groups
539569|NCT00666224|B2|Baseline|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539570|NCT00666224|B1|Baseline|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
539571|NCT00666224|P2|Participant Flow|Placebo (DB) to GA (OL)|Placebo matching glatiramer acetate given once daily by subcutaneous injection during the double-blind period (DB). Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Glatiramer acetate (GA) given 20 mg once daily by subcutaneous injection during the open-label period (OL).
539572|NCT00666224|P1|Participant Flow|Glatiramer Acetate|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the double-blind period. Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Participants in this treatment arm continued taking glatiramer acetate 20 mg once daily by subcutaneous injection during the open-label (OL) period.
539573|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539574|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
539575|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539576|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
539577|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539578|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
539579|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539580|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
539581|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539582|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
539583|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539584|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
539585|NCT00666224|E3|Reported Event|Glatiramer Acetate (Entire Study)|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection. GA adverse experiences from both the double-blind and open-label periods are combined in this column.
539586|NCT00666224|E2|Reported Event|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period. This subset of the GA treatment experience allows for comparison to the Placebo Double-blind Period data.
539587|NCT00666224|E1|Reported Event|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
539588|NCT00666211|B3|Baseline|Total|Total of all reporting groups
539589|NCT00666211|B2|Baseline|Opioid Titration|Pain will be Monitored and Medication Titrated
539590|NCT00666211|B1|Baseline|Standard of Care|Standard pain control drugs.
539592|NCT00666211|P1|Participant Flow|Standard of Care|Standard pain control drugs.
539593|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
539594|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
539595|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
539596|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
539597|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
539598|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
539599|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
539600|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
539601|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
539602|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
539603|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
539604|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
539605|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
539606|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
539607|NCT00666211|E2|Reported Event|Opioid Titration|Pain will be Monitored and Medication Titrated
539608|NCT00666211|E1|Reported Event|Standard of Care|Standard pain control drugs.
539609|NCT00666198|B1|Baseline|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539610|NCT00666198|P1|Participant Flow|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539611|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539612|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539613|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539614|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539615|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539616|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539617|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539618|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539619|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539620|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539621|NCT00666198|E1|Reported Event|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
539622|NCT00666029|B3|Baseline|Total|Total of all reporting groups
539623|NCT00666029|B2|Baseline|Placebo|"Placebo arm dummy pill~placebo: Placebo Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
539624|NCT00666029|B1|Baseline|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
539625|NCT00666029|P2|Participant Flow|Placebo|"Placebo arm dummy pill~placebo: Placebo"
539626|NCT00666029|P1|Participant Flow|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
539627|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill~placebo: Placebo"
539628|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
539629|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill~placebo: Placebo"
539630|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
539631|NCT00666029|E2|Reported Event|Placebo|"Placebo arm dummy pill~placebo: Placebo"
539632|NCT00666029|E1|Reported Event|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
539633|NCT00665925|B5|Baseline|Total|Total of all reporting groups
539634|NCT00665925|B4|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539635|NCT00665925|B3|Baseline|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539636|NCT00665925|B2|Baseline|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539637|NCT00665925|B1|Baseline|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539638|NCT00665925|P4|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539639|NCT00665925|P3|Participant Flow|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539640|NCT00665925|P2|Participant Flow|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539641|NCT00665925|P1|Participant Flow|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539642|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539643|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539644|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539645|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539646|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539647|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539648|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539649|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539650|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539651|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539652|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539653|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539654|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539655|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539656|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539657|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539658|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539659|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539660|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539661|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539662|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539663|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539664|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539665|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539666|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539667|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539668|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539669|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539670|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539671|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539672|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539673|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539674|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539675|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539676|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539677|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539678|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539679|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539680|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539681|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539682|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539683|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539684|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539685|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539686|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539687|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539688|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539689|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539690|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539691|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539692|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539693|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539694|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539695|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539696|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539697|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539698|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539699|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539700|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539701|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539702|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539703|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539704|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539705|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539706|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539707|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539708|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539709|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539710|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539711|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539712|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539713|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539714|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539715|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539716|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539717|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539718|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539719|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539720|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539721|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539722|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539723|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539724|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539725|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539726|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539727|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539728|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539729|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539730|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539731|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539732|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539733|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539734|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539735|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539736|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539737|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539738|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539739|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539740|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539741|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539742|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539743|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539744|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539745|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539746|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539747|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539748|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539749|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539750|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539751|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539752|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539753|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539754|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539755|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539756|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539757|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539758|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539759|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539760|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539761|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539762|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539763|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539764|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539765|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539766|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539767|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539768|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539769|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539770|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539771|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539772|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539773|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539774|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539775|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539776|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539777|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539778|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539779|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539780|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539781|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539782|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539783|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539784|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539785|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539786|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539787|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539788|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539789|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539790|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539791|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539792|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539793|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539794|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539795|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539796|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539797|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539798|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539799|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539800|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539801|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539802|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539803|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539804|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539805|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539806|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539807|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539808|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539809|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539810|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539811|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539812|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539813|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539814|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539815|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539816|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539817|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539818|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539819|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539820|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539821|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539822|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539823|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539824|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539825|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539826|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539827|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539828|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539829|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539830|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539831|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539832|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539833|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539834|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539835|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539836|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539837|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539838|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539839|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539840|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539841|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539842|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539843|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539844|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539845|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539846|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539847|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539848|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539849|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539850|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539851|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539852|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539853|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539854|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539855|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539856|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539857|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539858|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539859|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539860|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539861|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539862|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539863|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539864|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539865|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539866|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539867|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539868|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539869|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539870|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539871|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539872|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539873|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539874|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539875|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539876|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539877|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539878|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539879|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539880|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539881|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539882|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539883|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539884|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539885|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539886|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539887|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539888|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539889|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539890|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539891|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539892|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539893|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539894|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539895|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539896|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539897|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539898|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539899|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539900|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539901|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539902|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539903|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539904|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539905|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539906|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539907|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539908|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539909|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539910|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539911|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539912|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539913|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539914|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539915|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539916|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539917|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539918|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539919|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539920|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539921|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539922|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539923|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539924|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539925|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539926|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539927|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539928|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539929|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539930|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539931|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539932|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539933|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539934|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539935|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539936|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539937|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539938|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539939|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539940|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539941|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539942|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539943|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539944|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539945|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539946|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539947|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539948|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539949|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539950|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539951|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539952|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539953|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539954|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539955|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539956|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539957|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539958|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539959|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539960|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539961|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539962|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539963|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539964|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539965|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539966|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539967|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539968|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539969|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539970|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539971|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539972|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539973|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539974|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539975|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539976|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539977|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539978|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539979|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539980|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539981|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539982|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539983|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539984|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539985|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539986|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539987|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539988|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539989|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539990|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539991|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539992|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539993|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539994|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
539995|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
539996|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
539997|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
539998|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
539999|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540000|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540001|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540002|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540003|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540004|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540005|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540006|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540007|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540008|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540009|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540010|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540011|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540012|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540013|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540014|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540015|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540016|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540017|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540018|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540019|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540020|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540021|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540022|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540023|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540024|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540025|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540026|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540027|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540028|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540029|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540030|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540031|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540032|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540033|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540034|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540035|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540036|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540037|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540038|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540039|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540040|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540041|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540042|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540043|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540044|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
540045|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540046|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540047|NCT00665925|E4|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540048|NCT00665925|E3|Reported Event|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
540049|NCT00665925|E2|Reported Event|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
540050|NCT00665925|E1|Reported Event|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
540051|NCT00665847|B1|Baseline|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
540052|NCT00665847|P1|Participant Flow|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
540053|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540054|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540055|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540056|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540057|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540058|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540059|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540060|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540061|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
540062|NCT00665847|E1|Reported Event|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
540063|NCT00665704|B1|Baseline|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
540064|NCT00665704|P1|Participant Flow|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
540065|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
540066|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
540067|NCT00665704|E1|Reported Event|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
540068|NCT00665626|B3|Baseline|Total|Total of all reporting groups
540069|NCT00665626|B2|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540070|NCT00665626|B1|Baseline|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540071|NCT00665626|P2|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540072|NCT00665626|P1|Participant Flow|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540073|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540074|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540075|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540076|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540077|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540078|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540079|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540080|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540081|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540082|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540083|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540084|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540085|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540086|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540087|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540088|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540089|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540090|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540091|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540092|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540093|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540094|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540095|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540096|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540097|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540098|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540099|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540100|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540101|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540102|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540103|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540104|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540105|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540106|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540107|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540108|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540109|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540110|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540111|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540112|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540113|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540114|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540115|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540116|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540117|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540118|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540119|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540120|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540121|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540122|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540123|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540124|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540125|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540126|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540127|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540128|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540129|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540130|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540131|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540132|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540133|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540134|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540135|NCT00665626|E2|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
540136|NCT00665626|E1|Reported Event|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
540137|NCT00665470|B3|Baseline|Total|Total of all reporting groups
540138|NCT00665470|B2|Baseline|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
540139|NCT00665470|B1|Baseline|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
540140|NCT00665470|P2|Participant Flow|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
540141|NCT00665470|P1|Participant Flow|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
540142|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
540143|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
540144|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
540145|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
540146|NCT00665470|E2|Reported Event|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
540147|NCT00665470|E1|Reported Event|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
540148|NCT00665444|B1|Baseline|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540149|NCT00665444|P1|Participant Flow|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540150|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540151|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540199|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540200|NCT00665431|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540201|NCT00665431|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540271|NCT00664560|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540152|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540153|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540154|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540155|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540156|NCT00665444|E1|Reported Event|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
540157|NCT00665431|B4|Baseline|Total|Total of all reporting groups
540158|NCT00665431|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540159|NCT00665431|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540160|NCT00665431|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540161|NCT00665431|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540162|NCT00665431|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540163|NCT00665431|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540164|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540165|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540166|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540167|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540168|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540169|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540170|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540171|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540172|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540173|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540174|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540175|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540176|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540177|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540178|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540179|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540180|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540181|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540182|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540183|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540184|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540185|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540186|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540187|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540188|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540189|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540190|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540191|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540192|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540193|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540194|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540195|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540196|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540197|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540198|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540202|NCT00665431|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
540203|NCT00665366|B3|Baseline|Total|Total of all reporting groups
540204|NCT00665366|B2|Baseline|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540205|NCT00665366|B1|Baseline|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540206|NCT00665366|P2|Participant Flow|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540207|NCT00665366|P1|Participant Flow|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540208|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540209|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540210|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540211|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540212|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540213|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540214|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540215|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540216|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540217|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540218|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540219|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540266|NCT00664742|P1|Participant Flow|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
540267|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
540220|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540221|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540222|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540223|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540224|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540225|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540226|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540227|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540228|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540229|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540230|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
540231|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
540232|NCT00665366|E2|Reported Event|Placebo|
540233|NCT00665366|E1|Reported Event|Aripiprazole|
540234|NCT00665353|B1|Baseline|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540235|NCT00665353|P1|Participant Flow|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540236|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540237|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540238|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540239|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540268|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
540269|NCT00664742|E1|Reported Event|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
540240|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540241|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540242|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540243|NCT00665353|E1|Reported Event|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
540244|NCT00665132|B1|Baseline|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
540245|NCT00665132|P1|Participant Flow|StimRouter Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Patient is Implanted with StimRouter System lead and receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
540246|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
540247|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
540248|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
540249|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
540250|NCT00665132|E1|Reported Event|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
540251|NCT00665002|B1|Baseline|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
540252|NCT00665002|P1|Participant Flow|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
540253|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
540254|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
540255|NCT00665002|E1|Reported Event|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks.
540256|NCT00664755|B3|Baseline|Total|Total of all reporting groups
540257|NCT00664755|B2|Baseline|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
540258|NCT00664755|B1|Baseline|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
540259|NCT00664755|P2|Participant Flow|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
540260|NCT00664755|P1|Participant Flow|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
540261|NCT00664755|O2|Outcome|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
540262|NCT00664755|O1|Outcome|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
540263|NCT00664755|E2|Reported Event|Transdermal Nicotine Patch|"Participant randomized to receive active transdermal nicotine patch and placebo varenicline.~transdermal nicotine patch: Weeks 0-3: 21mg patch~Transdermal nicotine patch is used for a duration of 3 weeks in this study."
540264|NCT00664755|E1|Reported Event|Varenicline|"Participant randomized to receive active varenicline and placebo transdermal nicotine patch.~varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID~Varenicline is taken for a duration of 4 weeks in this study."
540265|NCT00664742|B1|Baseline|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
540272|NCT00664560|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540273|NCT00664560|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540274|NCT00664560|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540275|NCT00664560|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540276|NCT00664560|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540277|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540278|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540279|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540280|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540281|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540282|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540283|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540284|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540285|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540286|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540287|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540288|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540289|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540290|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540291|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540292|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540293|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540294|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540295|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540296|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540297|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540298|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540299|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540300|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540301|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540302|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540303|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540304|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540305|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540306|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540307|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540308|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540309|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540310|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540311|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540312|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540313|NCT00664560|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
540314|NCT00664560|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
540315|NCT00664560|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
540316|NCT00664534|B3|Baseline|Total|Total of all reporting groups
540317|NCT00664534|B2|Baseline|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540318|NCT00664534|B1|Baseline|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540319|NCT00664534|P2|Participant Flow|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540320|NCT00664534|P1|Participant Flow|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540321|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540322|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540323|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540324|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540325|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540326|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540327|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540328|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540329|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540330|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540331|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540332|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540333|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540334|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540335|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540336|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540337|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540338|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540339|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540340|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540341|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
540342|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
540343|NCT00664534|E2|Reported Event|Glargine|Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs
540344|NCT00664534|E1|Reported Event|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs
540345|NCT00664521|B3|Baseline|Total|Total of all reporting groups
540346|NCT00664521|B2|Baseline|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540347|NCT00664521|B1|Baseline|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540348|NCT00664521|P2|Participant Flow|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540349|NCT00664521|P1|Participant Flow|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540350|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540351|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540352|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540353|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540354|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540355|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540356|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540357|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540358|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540359|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540360|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540361|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540362|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540363|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540364|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540365|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540398|NCT00664209|O1|Outcome|Active|standard treatment with active triple therapy
540366|NCT00664521|E2|Reported Event|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
540367|NCT00664521|E1|Reported Event|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
540368|NCT00664430|B1|Baseline|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
540369|NCT00664430|P1|Participant Flow|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
540370|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
540371|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
540372|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
540373|NCT00664430|E1|Reported Event|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
540374|NCT00664326|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540375|NCT00664326|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540376|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540377|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540378|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540379|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540380|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540381|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540382|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540383|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540384|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540385|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540386|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540387|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540388|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540389|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540390|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540391|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540392|NCT00664326|E1|Reported Event|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
540393|NCT00664209|B1|Baseline|Active|H. Pylori positive participants screened for eligibility to a treatment assignment.
540394|NCT00664209|P1|Participant Flow|Active|"Those with significant wearing-off were to be assigned to arms, and received open-label triple eradication therapy (standard of care) per physician decision because the screen yield was too low to test effect size between arms.~---- Clarithromycin 500mg - i PO BID x10 days; Amoxicillin 1gm - i PO BID x10 days; Omeprazole 10mg - i PO BID x10 days"
540395|NCT00664209|O1|Outcome|Active|Standard treatment with active triple therapy
540396|NCT00664209|O1|Outcome|Active|Standard treatment with active triple therapy
540397|NCT00664209|O1|Outcome|Active|Standard treatment with active triple therapy
540399|NCT00664209|O1|Outcome|Active|Standard treatment with active triple therapy
540400|NCT00664209|E1|Reported Event|Active|Standard treatment with active triple therapy
540401|NCT00664105|B1|Baseline|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
540402|NCT00664105|P1|Participant Flow|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
540403|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
540404|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
540405|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
540406|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
540407|NCT00664105|E1|Reported Event|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
540408|NCT00664066|B1|Baseline|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
540409|NCT00664066|P1|Participant Flow|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
540410|NCT00664066|O1|Outcome|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
540411|NCT00664066|E1|Reported Event|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
540412|NCT00663962|B3|Baseline|Total|Total of all reporting groups
540413|NCT00663962|B2|Baseline|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
540414|NCT00663962|B1|Baseline|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
540415|NCT00663962|P2|Participant Flow|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
540416|NCT00663962|P1|Participant Flow|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
540417|NCT00663962|O2|Outcome|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
540418|NCT00663962|O1|Outcome|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
540419|NCT00663962|E2|Reported Event|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
540420|NCT00663962|E1|Reported Event|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
540421|NCT00663923|B1|Baseline|Photorefractive Keratectomy( PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .In single method the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540422|NCT00663923|P1|Participant Flow|Photorefractivekeratectomy(PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .in single method,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540423|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540424|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
540425|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540564|NCT00663208|B1|Baseline|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540426|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
540427|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540428|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
540429|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540430|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
540431|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540432|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
540433|NCT00663923|E2|Reported Event|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
540434|NCT00663923|E1|Reported Event|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
540435|NCT00663858|B4|Baseline|Total|Total of all reporting groups
540436|NCT00663858|B3|Baseline|Placebo|Placebo on Week 0, 2, 26 and 28.
540437|NCT00663858|B2|Baseline|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
540438|NCT00663858|B1|Baseline|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
540439|NCT00663858|P3|Participant Flow|Placebo|Placebo on Week 0, 2, 26 and 28.
540440|NCT00663858|P2|Participant Flow|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
540441|NCT00663858|P1|Participant Flow|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
540442|NCT00663858|O3|Outcome|Placebo|Placebo on Week 0, 2, 26 and 28.
540443|NCT00663858|O2|Outcome|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
540444|NCT00663858|O1|Outcome|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
540445|NCT00663858|E3|Reported Event|Placebo|Placebo on Week 0, 2, 26 and 28.
540446|NCT00663858|E2|Reported Event|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
540447|NCT00663858|E1|Reported Event|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
540448|NCT00663819|B3|Baseline|Total|Total of all reporting groups
540449|NCT00663819|B2|Baseline|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
540450|NCT00663819|B1|Baseline|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
540451|NCT00663819|P2|Participant Flow|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
540452|NCT00663819|P1|Participant Flow|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
540453|NCT00663819|O2|Outcome|Procedure/Surgery|Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
540454|NCT00663819|O1|Outcome|Device|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
540455|NCT00663819|O2|Outcome|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
540456|NCT00663819|O1|Outcome|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
540457|NCT00663819|O2|Outcome|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
540458|NCT00663819|O1|Outcome|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
540459|NCT00663819|O2|Outcome|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
540460|NCT00663819|O1|Outcome|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
540461|NCT00663819|E2|Reported Event|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
540462|NCT00663819|E1|Reported Event|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
540463|NCT00663793|B3|Baseline|Total|Total of all reporting groups
540464|NCT00663793|B2|Baseline|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540465|NCT00663793|B1|Baseline|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540466|NCT00663793|P2|Participant Flow|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540467|NCT00663793|P1|Participant Flow|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540468|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540469|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540470|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540471|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540472|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540503|NCT00663403|P1|Participant Flow|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540473|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540474|NCT00663793|E2|Reported Event|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540475|NCT00663793|E1|Reported Event|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
540476|NCT00663702|B3|Baseline|Total|Total of all reporting groups
540477|NCT00663702|B2|Baseline|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540478|NCT00663702|B1|Baseline|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540479|NCT00663702|P2|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540480|NCT00663702|P1|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540481|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540482|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540483|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540484|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540485|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540486|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540487|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
542674|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
540488|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540489|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540490|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540491|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540492|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540493|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540494|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540495|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540496|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540497|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540498|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540499|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540500|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540501|NCT00663702|E1|Reported Event|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
540502|NCT00663403|B1|Baseline|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
542062|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
540504|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540505|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540506|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540507|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540508|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540509|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540510|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540511|NCT00663403|E1|Reported Event|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
540512|NCT00663260|B4|Baseline|Total|Total of all reporting groups
540513|NCT00663260|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540514|NCT00663260|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540515|NCT00663260|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
540516|NCT00663260|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540517|NCT00663260|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540518|NCT00663260|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
540519|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540520|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540521|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
540522|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540523|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540524|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
540525|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540526|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540527|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
540528|NCT00663260|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540529|NCT00663260|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
540530|NCT00663260|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
540531|NCT00663234|B1|Baseline|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540532|NCT00663234|P1|Participant Flow|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.
540533|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
540534|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
540535|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
540536|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
540537|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540538|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540539|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540540|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540541|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540542|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540543|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540544|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540545|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540546|NCT00663234|O2|Outcome|NNRTI-unexposed|Participant was not on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
540547|NCT00663234|O1|Outcome|NNRTI-exposed|Participant was on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
540548|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
540549|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
540550|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540551|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540552|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540553|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540554|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540555|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540556|NCT00663234|E1|Reported Event|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
540557|NCT00663208|B8|Baseline|Total|Total of all reporting groups
540558|NCT00663208|B7|Baseline|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540559|NCT00663208|B6|Baseline|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540560|NCT00663208|B5|Baseline|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540561|NCT00663208|B4|Baseline|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540562|NCT00663208|B3|Baseline|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540563|NCT00663208|B2|Baseline|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540565|NCT00663208|P7|Participant Flow|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540566|NCT00663208|P6|Participant Flow|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540567|NCT00663208|P5|Participant Flow|Daclatasvir (30 mg) BID|Participants received twice daily (BID) dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540568|NCT00663208|P4|Participant Flow|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540569|NCT00663208|P3|Participant Flow|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540570|NCT00663208|P2|Participant Flow|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540571|NCT00663208|P1|Participant Flow|Daclatasvir (1 mg) QD|Participants received once daily (QD) dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540572|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540573|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540574|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540575|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540576|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540577|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540578|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540579|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540580|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540581|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540582|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540583|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540584|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540585|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540586|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540587|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540588|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540589|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540590|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540591|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540592|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540593|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540594|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
542063|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
540595|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540596|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540597|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540598|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540599|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540600|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540601|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540602|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540603|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540604|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540605|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540606|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540607|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540608|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540609|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540610|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540611|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540612|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540613|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540614|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540615|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540616|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540617|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540618|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540619|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540620|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540621|NCT00663208|O1|Outcome|All Daclatasvir Treated Participants|All participants who received daclatasvir during 14 day treatment period.
540622|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540623|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540624|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540625|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540626|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540627|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540628|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540629|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540630|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540631|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540632|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540633|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540634|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540635|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540636|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540637|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540638|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540639|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540640|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540641|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540642|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540643|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540644|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540645|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540646|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540647|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540648|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540649|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540650|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540651|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540652|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540653|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540654|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540655|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540656|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540657|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540658|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540659|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540660|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540661|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540662|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540663|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540664|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540665|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540666|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540667|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540668|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540669|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540670|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540671|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540672|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540673|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540674|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540675|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540676|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540677|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540678|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540679|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540680|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540681|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540682|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540683|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540684|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540685|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540686|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540796|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540687|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540688|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540689|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540690|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540691|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540692|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540693|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540694|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540695|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182..
540696|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540697|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540698|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540699|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540700|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540701|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540702|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540703|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540704|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540705|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540706|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540707|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540708|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540709|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540710|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540711|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540712|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540713|NCT00663208|E7|Reported Event|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
540714|NCT00663208|E6|Reported Event|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540715|NCT00663208|E5|Reported Event|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540716|NCT00663208|E4|Reported Event|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540873|NCT00662909|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540717|NCT00663208|E3|Reported Event|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540718|NCT00663208|E2|Reported Event|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540719|NCT00663208|E1|Reported Event|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received Daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
540720|NCT00663169|B3|Baseline|Total|Total of all reporting groups
540721|NCT00663169|B2|Baseline|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540722|NCT00663169|B1|Baseline|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540723|NCT00663169|P2|Participant Flow|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540724|NCT00663169|P1|Participant Flow|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540725|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540726|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540727|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540728|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540729|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540730|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540731|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540732|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540733|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540734|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540735|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540736|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540737|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540738|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540739|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540740|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540741|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540742|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540743|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540744|NCT00663169|E2|Reported Event|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
540745|NCT00663169|E1|Reported Event|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
540746|NCT00663117|B3|Baseline|Total|Total of all reporting groups
540747|NCT00663117|B2|Baseline|Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
540748|NCT00663117|B1|Baseline|Placebo Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
540749|NCT00663117|P2|Participant Flow|Naltrexone Then Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
540750|NCT00663117|P1|Participant Flow|Placebo Then Naltrexone 4.5 mg Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
540751|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Subjects who received naltrexone 4.5 mg by mouth once a day for 3 months
540752|NCT00663117|O1|Outcome|Placebo|Subjects who received placebo for 3 months
540753|NCT00663117|O2|Outcome|Naltrexone 4.5 mg|naltrexone 4.5 mg for 12 weeks blinded followed by naltrexone 4.5 mg open labeled
540754|NCT00663117|O1|Outcome|Placebo|Placebo for 12 weeks blinded followed by naltrexone 4.5mg open labeled
540755|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Quality of life on naltrexone treatment 12 weeks
540756|NCT00663117|O1|Outcome|Placebo|Quality of life in subjects on placebo treatment for 12 weeks
540757|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
540758|NCT00663117|O1|Outcome|Placebo|Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
540759|NCT00663117|E2|Reported Event|Naltrexone 4.5 mg|All participants who received naltrexone either for 12 or 24 weeks.
540760|NCT00663117|E1|Reported Event|Placebo|Participants who received placebo for the first 12 weeks.
540761|NCT00663052|B3|Baseline|Total|Total of all reporting groups
540762|NCT00663052|B2|Baseline|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540763|NCT00663052|B1|Baseline|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540764|NCT00663052|P2|Participant Flow|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540765|NCT00663052|P1|Participant Flow|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540766|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540767|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540768|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540769|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540770|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540771|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540772|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540773|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540774|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540775|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540776|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540777|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540778|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540779|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540780|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540781|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540782|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540783|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540784|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540785|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540786|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540787|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540788|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540789|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540790|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540791|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540792|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540793|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540794|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540795|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540874|NCT00662909|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540797|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540798|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540799|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540800|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540801|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540802|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540803|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540804|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540805|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540806|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540807|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540808|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540809|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540810|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540811|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540812|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540813|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540814|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540815|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540816|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540817|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540818|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540819|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540820|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540821|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540822|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540823|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540824|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540825|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540826|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540827|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540828|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540875|NCT00662909|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540829|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540830|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540831|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540832|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540833|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540834|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540835|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540836|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540837|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540838|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540839|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540840|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540841|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540842|NCT00663052|E2|Reported Event|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
540843|NCT00663052|E1|Reported Event|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
540844|NCT00663026|B4|Baseline|Total|Total of all reporting groups
540845|NCT00663026|B3|Baseline|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540846|NCT00663026|B2|Baseline|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540847|NCT00663026|B1|Baseline|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
540848|NCT00663026|P3|Participant Flow|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540849|NCT00663026|P2|Participant Flow|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540850|NCT00663026|P1|Participant Flow|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
540851|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540852|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540853|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540854|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540855|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540856|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540857|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540858|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540859|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540860|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540861|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540862|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540863|NCT00663026|O3|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540864|NCT00663026|O2|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540865|NCT00663026|O1|Outcome|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
540866|NCT00663026|E3|Reported Event|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
540867|NCT00663026|E2|Reported Event|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
540868|NCT00663026|E1|Reported Event|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
540869|NCT00662909|B4|Baseline|Total|Total of all reporting groups
540870|NCT00662909|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540871|NCT00662909|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540872|NCT00662909|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540876|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540877|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540878|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540879|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540880|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540881|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540882|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540883|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540884|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540885|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540886|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540887|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540888|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540889|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540890|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540891|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540892|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540893|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540894|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540895|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540896|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540897|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540898|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540899|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540900|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540901|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540902|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540903|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540904|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540905|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540906|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540907|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540908|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540909|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540910|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540911|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540912|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540913|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540914|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540915|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540916|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540917|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540918|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540919|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540920|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540921|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540922|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540923|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540924|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540925|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540926|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540927|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540928|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540929|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540930|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540931|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540932|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540933|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540934|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540935|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540936|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540937|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540938|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540939|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540940|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540941|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540942|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540943|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540944|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540945|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540946|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540947|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540948|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540949|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540950|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540951|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540952|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540953|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540954|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540955|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540956|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540957|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540958|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540959|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540960|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540961|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540962|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540963|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540964|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540965|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540966|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540967|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540968|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540969|NCT00662909|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
540970|NCT00662909|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
540971|NCT00662909|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
540972|NCT00662857|B1|Baseline|Safety Population|Any subject that received at least one treatment with TI inhalation powder
540973|NCT00662857|P2|Participant Flow|TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
540974|NCT00662857|P1|Participant Flow|TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
540975|NCT00662857|O2|Outcome|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
540976|NCT00662857|O1|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
542064|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
540977|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
540978|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
540979|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
540980|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
540981|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
540982|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
540983|NCT00662857|E3|Reported Event|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
540984|NCT00662857|E2|Reported Event|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
540985|NCT00662857|E1|Reported Event|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
540986|NCT00662831|B3|Baseline|Total|Total of all reporting groups
540987|NCT00662831|B2|Baseline|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
540988|NCT00662831|B1|Baseline|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
540989|NCT00662831|P2|Participant Flow|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
540990|NCT00662831|P1|Participant Flow|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 milliliter [mL]) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
540991|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
540992|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
540993|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
540994|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
540995|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
540996|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
540997|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
540998|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
540999|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541000|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541001|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541002|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541003|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541004|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541005|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541006|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541007|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541008|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541009|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541010|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541011|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541012|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541013|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541014|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541015|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541016|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541017|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541018|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541019|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541020|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541021|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
542065|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
541022|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541023|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541024|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541025|NCT00662831|E2|Reported Event|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
541026|NCT00662831|E1|Reported Event|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
541027|NCT00662818|B3|Baseline|Total|Total of all reporting groups
541028|NCT00662818|B2|Baseline|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
541029|NCT00662818|B1|Baseline|Telcagepant 300 mg→APAP 1000 mg|Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
541030|NCT00662818|P2|Participant Flow|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
541031|NCT00662818|P1|Participant Flow|Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg|Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
541032|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
541033|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541034|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
541035|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541036|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
541037|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541038|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
541039|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541040|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
541041|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541042|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
541043|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541044|NCT00662818|O2|Outcome|Acetaminophen/Paracetamol (APAP)|Participants receiving APAP
541045|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541046|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
541047|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541048|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
541049|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
541050|NCT00662818|E2|Reported Event|Acetaminophen/Paracetamol|Participants receiving acetaminophen/paracetamol
541051|NCT00662818|E1|Reported Event|Telcagepant|Participants receiving telcagepant
541052|NCT00662675|B3|Baseline|Total|Total of all reporting groups
541053|NCT00662675|B2|Baseline|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
541054|NCT00662675|B1|Baseline|Placebo|Matching placebo capsules taken by mouth per meal or snack
541055|NCT00662675|P2|Participant Flow|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
541056|NCT00662675|P1|Participant Flow|Placebo|Matching placebo capsules taken by mouth per meal or snack
541057|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
541058|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
541059|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
541060|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
541061|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
541062|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
541063|NCT00662675|E2|Reported Event|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
541064|NCT00662675|E1|Reported Event|Placebo|Matching placebo capsules taken by mouth per meal or snack
541065|NCT00662649|B5|Baseline|Total|Total of all reporting groups
541066|NCT00662649|B4|Baseline|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
541067|NCT00662649|B3|Baseline|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
541068|NCT00662649|B2|Baseline|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541069|NCT00662649|B1|Baseline|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541070|NCT00662649|P5|Participant Flow|Placebo-fingolimod 0.5|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
541071|NCT00662649|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
541072|NCT00662649|P3|Participant Flow|Placebo|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
541073|NCT00662649|P2|Participant Flow|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541074|NCT00662649|P1|Participant Flow|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541075|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
541076|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541077|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541078|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod (either 1.25 or 0.5 mg/day) in the Extension study.
541079|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541080|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541081|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
541082|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the Core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
541083|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541084|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541085|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
541086|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
541087|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541088|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541089|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
541090|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
541091|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541092|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541093|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
541094|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
541095|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541096|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541097|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
541098|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541099|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541100|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
541101|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
541102|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541103|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541104|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
541105|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
541106|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
541107|NCT00662649|E4|Reported Event|Placebo-Fingolimod 0.5mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study.
541108|NCT00662649|E3|Reported Event|Placebo-Fingolimod 1.25mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study.
542675|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
541109|NCT00662649|E2|Reported Event|Fingolimod 0.5mg|Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study.
541110|NCT00662649|E1|Reported Event|Fingolimod 1.25mg|Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study.
541111|NCT00662558|B3|Baseline|Total|Total of all reporting groups
541112|NCT00662558|B2|Baseline|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541113|NCT00662558|B1|Baseline|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541114|NCT00662558|P2|Participant Flow|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541115|NCT00662558|P1|Participant Flow|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541116|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541117|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541118|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541119|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541120|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541121|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541122|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541123|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541124|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541125|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541126|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541127|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541128|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541129|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541130|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541131|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541132|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541133|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541134|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541135|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541136|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541137|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541138|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541139|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541140|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541141|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541142|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541143|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541144|NCT00662558|E2|Reported Event|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
541145|NCT00662558|E1|Reported Event|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
541146|NCT00662545|B3|Baseline|Total|Total of all reporting groups
541147|NCT00662545|B2|Baseline|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
541148|NCT00662545|B1|Baseline|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541149|NCT00662545|P2|Participant Flow|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
541150|NCT00662545|P1|Participant Flow|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541151|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
541152|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541153|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
541154|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541155|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
541156|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541157|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
541158|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541159|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
541160|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541161|NCT00662545|E2|Reported Event|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
542066|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
541162|NCT00662545|E1|Reported Event|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
541163|NCT00662532|B3|Baseline|Total|Total of all reporting groups
541164|NCT00662532|B2|Baseline|No Intervention|Control group receiving no drug intervention
541165|NCT00662532|B1|Baseline|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
541166|NCT00662532|P2|Participant Flow|No Intervention|Control group receiving no drug intervention
541167|NCT00662532|P1|Participant Flow|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
541168|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
541169|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
541170|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
541171|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
541172|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
541173|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
541174|NCT00662532|E2|Reported Event|No Intervention|Control group receiving no drug intervention
541175|NCT00662532|E1|Reported Event|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
541176|NCT00662389|B1|Baseline|A--Thermal Wand Application|
541177|NCT00662389|P1|Participant Flow|A--Thermal Wand Application|
541178|NCT00662389|O1|Outcome|A--Thermal Wand Application|
541179|NCT00662363|B3|Baseline|Total|Total of all reporting groups
541180|NCT00662363|B2|Baseline|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
541181|NCT00662363|B1|Baseline|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
541182|NCT00662363|P2|Participant Flow|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
541183|NCT00662363|P1|Participant Flow|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
541184|NCT00662363|O2|Outcome|Senna|Change in PAC-QOL
541185|NCT00662363|O1|Outcome|Lubiprostone|change in PAC-QOL
541186|NCT00662363|O2|Outcome|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
541187|NCT00662363|O1|Outcome|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
541188|NCT00662363|E2|Reported Event|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
541189|NCT00662363|E1|Reported Event|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
541190|NCT00662311|B4|Baseline|Total|Total of all reporting groups
541191|NCT00662311|B3|Baseline|Vorinostat 400 mg|"Cohort 3: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541192|NCT00662311|B2|Baseline|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541193|NCT00662311|B1|Baseline|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541194|NCT00662311|P3|Participant Flow|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541195|NCT00662311|P2|Participant Flow|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541196|NCT00662311|P1|Participant Flow|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541197|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541198|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541199|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541200|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541446|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541201|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541202|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541203|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541204|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541205|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541206|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541207|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541208|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541209|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541210|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541211|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541212|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541213|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541214|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541215|NCT00662311|E3|Reported Event|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541216|NCT00662311|E2|Reported Event|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541217|NCT00662311|E1|Reported Event|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
541218|NCT00662207|B1|Baseline|All Participants|
541248|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541219|NCT00662207|P1|Participant Flow|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
541220|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
541221|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
541222|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
541223|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
541224|NCT00662207|E1|Reported Event|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
541225|NCT00662155|B5|Baseline|Total|Total of all reporting groups
541226|NCT00662155|B4|Baseline|QHS-5|nightly dosing with 5mg zolpidem
541227|NCT00662155|B3|Baseline|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
541228|NCT00662155|B2|Baseline|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
541229|NCT00662155|B1|Baseline|QHS-10|nightly dosing with 10 mg zolpidem
541230|NCT00662155|P4|Participant Flow|QHS-5|nightly dosing with 5mg zolpidem
541231|NCT00662155|P3|Participant Flow|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
541232|NCT00662155|P2|Participant Flow|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
541233|NCT00662155|P1|Participant Flow|QHS-10|nightly dosing with 10 mg zolpidem
541234|NCT00662155|O4|Outcome|QHS-5|nightly dosing with 5mg zolpidem
541235|NCT00662155|O3|Outcome|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
541236|NCT00662155|O2|Outcome|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
541237|NCT00662155|O1|Outcome|QHS-10|nightly dosing with 10 mg zolpidem
541238|NCT00662155|O4|Outcome|QHS-5|nightly dosing with 5mg zolpidem
541239|NCT00662155|O3|Outcome|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
541240|NCT00662155|O2|Outcome|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
541241|NCT00662155|O1|Outcome|QHS-10|nightly dosing with 10 mg zolpidem
541242|NCT00662155|E4|Reported Event|QHS-5|nightly dosing with 5mg zolpidem
541243|NCT00662155|E3|Reported Event|PRS-10|"nightly pill use (50% 10mg zolpidem and 50% placebos)"
541244|NCT00662155|E2|Reported Event|IDS-10|intermittent dosing (3-5 days per week) with 10mg zolpidem
541245|NCT00662155|E1|Reported Event|QHS-10|nightly dosing with 10 mg zolpidem
541246|NCT00662129|B1|Baseline|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541247|NCT00662129|P1|Participant Flow|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541332|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541249|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541250|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541251|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541252|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541253|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541254|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541255|NCT00662129|E1|Reported Event|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541256|NCT00662038|B1|Baseline|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
541257|NCT00662038|P1|Participant Flow|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
541258|NCT00662038|O1|Outcome|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
541259|NCT00662038|E1|Reported Event|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
541260|NCT00662025|B1|Baseline|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541261|NCT00662025|P1|Participant Flow|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541262|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541263|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541264|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541265|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541266|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
542676|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
541267|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541268|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541269|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541270|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541271|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541272|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541273|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541274|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541275|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541276|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541277|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541278|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541279|NCT00662025|E1|Reported Event|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
541368|NCT00661830|P2|Participant Flow|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
541280|NCT00662012|B1|Baseline|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
541281|NCT00662012|P1|Participant Flow|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
541282|NCT00662012|O1|Outcome|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
541283|NCT00662012|O1|Outcome|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
541284|NCT00662012|E1|Reported Event|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
541285|NCT00661999|B4|Baseline|Total|Total of all reporting groups
541286|NCT00661999|B3|Baseline|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541287|NCT00661999|B2|Baseline|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541288|NCT00661999|B1|Baseline|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541289|NCT00661999|P3|Participant Flow|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541290|NCT00661999|P2|Participant Flow|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541291|NCT00661999|P1|Participant Flow|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541292|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541293|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541294|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541295|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541296|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541297|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541298|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541299|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541300|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541301|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541302|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
542677|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
541303|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541304|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541305|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541306|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541307|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541308|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541309|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541310|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541311|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541312|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541313|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541314|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541315|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541316|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541317|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541318|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541319|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541320|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541321|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541322|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541323|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541324|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541325|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541326|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541327|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541328|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541329|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541330|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541331|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
542067|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
541333|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541334|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541335|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541336|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541337|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541338|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541339|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541340|NCT00661999|E3|Reported Event|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541341|NCT00661999|E2|Reported Event|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541342|NCT00661999|E1|Reported Event|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
541343|NCT00661960|B4|Baseline|Total|Total of all reporting groups
541344|NCT00661960|B3|Baseline|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
541345|NCT00661960|B2|Baseline|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
541346|NCT00661960|B1|Baseline|Negative Volunteers|HIV Negative volunteers
541347|NCT00661960|P3|Participant Flow|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
541348|NCT00661960|P2|Participant Flow|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
541349|NCT00661960|P1|Participant Flow|Negative Volunteers|HIV Negative volunteers
541350|NCT00661960|O3|Outcome|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
541351|NCT00661960|O2|Outcome|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
541352|NCT00661960|O1|Outcome|Negative Volunteers|HIV Negative volunteers
541353|NCT00661960|E3|Reported Event|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
541354|NCT00661960|E2|Reported Event|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
541355|NCT00661960|E1|Reported Event|Negative Volunteers|HIV Negative volunteers
541356|NCT00661895|B3|Baseline|Total|Total of all reporting groups
541357|NCT00661895|B2|Baseline|Control|No intervention
541358|NCT00661895|B1|Baseline|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
541359|NCT00661895|P2|Participant Flow|Control|No intervention
541360|NCT00661895|P1|Participant Flow|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
541361|NCT00661895|O2|Outcome|Control|Free antihypertensive medications, basic hypertension education and usual clinical care.
541362|NCT00661895|O1|Outcome|Intervention|Free antihypertensive medications, in-depth HTN and healthy living education, behavior change counseling, and Therapeutic Lifestyle Change following JNC-VII guidelines.
541363|NCT00661895|E2|Reported Event|Control|No intervention
541364|NCT00661895|E1|Reported Event|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
541365|NCT00661830|B3|Baseline|Total|Total of all reporting groups
541366|NCT00661830|B2|Baseline|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
541367|NCT00661830|B1|Baseline|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
541396|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541369|NCT00661830|P1|Participant Flow|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
541370|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
541371|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
541372|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
541373|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
541374|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
541375|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
541376|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
541377|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
541378|NCT00661830|E2|Reported Event|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
541379|NCT00661830|E1|Reported Event|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
541380|NCT00661778|B1|Baseline|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
541381|NCT00661778|P1|Participant Flow|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
541382|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
541383|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
541384|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
541385|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
541386|NCT00661778|E1|Reported Event|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
541387|NCT00661726|B1|Baseline|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
541388|NCT00661726|P1|Participant Flow|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
541389|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541390|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541391|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541392|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541393|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541394|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541395|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
542068|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
541397|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541398|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541399|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541400|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541401|NCT00661726|E1|Reported Event|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
541402|NCT00661713|B9|Baseline|Total|Total of all reporting groups
541403|NCT00661713|B8|Baseline|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541404|NCT00661713|B7|Baseline|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541405|NCT00661713|B6|Baseline|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541406|NCT00661713|B5|Baseline|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541407|NCT00661713|B4|Baseline|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541408|NCT00661713|B3|Baseline|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541409|NCT00661713|B2|Baseline|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541410|NCT00661713|B1|Baseline|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541411|NCT00661713|P8|Participant Flow|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541412|NCT00661713|P7|Participant Flow|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541413|NCT00661713|P6|Participant Flow|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541414|NCT00661713|P5|Participant Flow|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541415|NCT00661713|P4|Participant Flow|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541416|NCT00661713|P3|Participant Flow|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541417|NCT00661713|P2|Participant Flow|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541418|NCT00661713|P1|Participant Flow|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541419|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541420|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541421|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541422|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541423|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541424|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541425|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541426|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541427|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541428|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541429|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541430|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541431|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541432|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541433|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541434|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541435|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541436|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541437|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541438|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541439|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541440|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541441|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541442|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541443|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541444|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541445|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
542678|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
541447|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541448|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541449|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541450|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541451|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541452|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541453|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541454|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541455|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541456|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541457|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541458|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541459|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541460|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541461|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541462|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541463|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541464|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541465|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541466|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541467|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541468|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541469|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541470|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541471|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541472|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541473|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541474|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541475|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541476|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541477|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541478|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541479|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541480|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541481|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541482|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541483|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541484|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541485|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541486|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541487|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541488|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541489|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541490|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541491|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541492|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541493|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541494|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541495|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541496|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541497|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541498|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541499|NCT00661713|E8|Reported Event|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
541500|NCT00661713|E7|Reported Event|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
541501|NCT00661713|E6|Reported Event|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
541502|NCT00661713|E5|Reported Event|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
541503|NCT00661713|E4|Reported Event|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
541504|NCT00661713|E3|Reported Event|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
541505|NCT00661713|E2|Reported Event|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
541506|NCT00661713|E1|Reported Event|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
541507|NCT00661687|B1|Baseline|PureVision Contact Lens|PureVision Contact Lens Original Design and New Design.
541508|NCT00661687|P1|Participant Flow|PureVision Contact Lens|PureVision Contact Lens, Original Design and Alternate Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
541509|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
541510|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
541511|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
541512|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
541513|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
541514|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
541515|NCT00661687|E2|Reported Event|PureVision Contact Lens Design #2|PureVision Contact Lens Test Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye
541516|NCT00661687|E1|Reported Event|PureVision Contact Lens Design #1|PureVision Contact Lens, Original Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
541517|NCT00661674|B1|Baseline|Overall Study|Over three study sessions each spaced one week apart participants received either placebo IV + PO, Palonosetron IV (0.75 mg) + placebo PO, or Palonosetron IV (0.75 mg) + Hydroxyzine PO (100mg).
541518|NCT00661674|P6|Participant Flow|Sequence 6: Palonosetron, Placebo, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Palonosetron~Week 2: Placebo~Week 3: Combo"
541519|NCT00661674|P5|Participant Flow|Sequence 5: Combo, Palonosetron, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Combo~Week 2: Palonosetron~Week 3: Placebo"
541520|NCT00661674|P4|Participant Flow|Sequence 4: Placebo, Palonosetron, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Placebo~Week 2: Palonosetron~Week 3: Combo"
541521|NCT00661674|P3|Participant Flow|Sequence 3: Combo, Placebo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Combo~Week 2: Placebo~Week 3: Palonosetron"
541522|NCT00661674|P2|Participant Flow|Sequence 2: Palonosetron, Combo, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Palonosetron~Week 2: Combo~Week 3: Placebo"
541786|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541523|NCT00661674|P1|Participant Flow|Sequence 1: Placebo, Combo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Placebo~Week 2: Combo~Week 3: Palonosetron"
541524|NCT00661674|O3|Outcome|Palonosetron + Hydroxyzine|Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
541525|NCT00661674|O2|Outcome|Palonosetron|Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
541526|NCT00661674|O1|Outcome|Placebo|Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
541527|NCT00661674|O3|Outcome|Palonosetron + Hydroxyzine|Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
541528|NCT00661674|O2|Outcome|Palonosetron|Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
541529|NCT00661674|O1|Outcome|Placebo|Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
541530|NCT00661674|E3|Reported Event|Palonosetron + Hydroxyzine|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
541531|NCT00661674|E2|Reported Event|Palonosetron + Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study drug combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
541532|NCT00661674|E1|Reported Event|Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with placebo (0.9% normal saline) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
541533|NCT00661661|B3|Baseline|Total|Total of all reporting groups
541534|NCT00661661|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541535|NCT00661661|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541536|NCT00661661|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541537|NCT00661661|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541538|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541539|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541540|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
542679|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
541541|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541542|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541543|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541544|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541545|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541546|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541547|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541548|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541549|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541550|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541551|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541552|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541553|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541554|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541555|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541556|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541657|NCT00661570|P1|Participant Flow|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
541557|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541558|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541559|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541560|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541561|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541562|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541563|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541564|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541565|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541566|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541567|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541568|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541569|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541570|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541571|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541572|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541658|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
541573|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541574|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541575|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541576|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541577|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541578|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541579|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541580|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541581|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541582|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541583|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541584|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541585|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541586|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541587|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541588|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541655|NCT00661583|E1|Reported Event|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
541589|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541590|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541591|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541592|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541593|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541594|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541595|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541596|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541597|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541598|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541599|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541600|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541601|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541602|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541603|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541604|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541656|NCT00661570|B1|Baseline|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
541605|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541606|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541607|NCT00661661|E3|Reported Event|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
541608|NCT00661661|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
541609|NCT00661661|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
541610|NCT00661622|B3|Baseline|Total|Total of all reporting groups
541611|NCT00661622|B2|Baseline|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541612|NCT00661622|B1|Baseline|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541613|NCT00661622|P2|Participant Flow|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541614|NCT00661622|P1|Participant Flow|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541615|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541616|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541617|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541618|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541619|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541620|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541621|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541750|NCT00661427|O2|Outcome|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
541622|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541623|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541624|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541625|NCT00661622|E2|Reported Event|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
541626|NCT00661622|E1|Reported Event|Immunoembolization|Liver embolization treatment with injection of GM-CSF.
541627|NCT00661609|B1|Baseline|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
541628|NCT00661609|P1|Participant Flow|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
541629|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
541630|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
541631|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
541632|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
541633|NCT00661609|E1|Reported Event|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
541634|NCT00661583|B4|Baseline|Total|Total of all reporting groups
541635|NCT00661583|B3|Baseline|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
541636|NCT00661583|B2|Baseline|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
541637|NCT00661583|B1|Baseline|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
541638|NCT00661583|P3|Participant Flow|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
541639|NCT00661583|P2|Participant Flow|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
541640|NCT00661583|P1|Participant Flow|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
541641|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
541642|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
541643|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
541644|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
541645|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
541646|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
541647|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
541648|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
541649|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
541650|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
541651|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
541652|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
541653|NCT00661583|E3|Reported Event|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
541654|NCT00661583|E2|Reported Event|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
541751|NCT00661427|O1|Outcome|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
541659|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
541660|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
541661|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
541662|NCT00661570|E1|Reported Event|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
541663|NCT00661544|B1|Baseline|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
541664|NCT00661544|P1|Participant Flow|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
541665|NCT00661544|O1|Outcome|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
541666|NCT00661544|E1|Reported Event|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
541667|NCT00661531|B1|Baseline|Estrace & Anastrozole|Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
541668|NCT00661531|P1|Participant Flow|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
541669|NCT00661531|O1|Outcome|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
541670|NCT00661531|O1|Outcome|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
541671|NCT00661531|E1|Reported Event|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
541672|NCT00661505|B1|Baseline|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541673|NCT00661505|P1|Participant Flow|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541674|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541675|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541676|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541752|NCT00661427|O2|Outcome|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
541677|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541678|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541679|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541680|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541681|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541682|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541683|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541684|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541685|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541686|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541753|NCT00661427|O1|Outcome|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
541754|NCT00661427|E2|Reported Event|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
541755|NCT00661427|E1|Reported Event|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
541787|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541687|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541688|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541689|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541690|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541691|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541692|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541693|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541694|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541695|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541696|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541756|NCT00661388|B1|Baseline|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541788|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
542069|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
541697|NCT00661505|E1|Reported Event|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
541698|NCT00661492|B3|Baseline|Total|Total of all reporting groups
541699|NCT00661492|B2|Baseline|Arm 2|Novantrone
541700|NCT00661492|B1|Baseline|Arm 1|Novantrone+Erbitux
541701|NCT00661492|P2|Participant Flow|Arm 2|Novantrone
541702|NCT00661492|P1|Participant Flow|Arm 1|Novantrone+Erbitux
541703|NCT00661492|O2|Outcome|Arm 2|Novantrone
541704|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541705|NCT00661492|O2|Outcome|Arm 2|Novantrone
541706|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541707|NCT00661492|O2|Outcome|Arm 2|Novantrone
541708|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541709|NCT00661492|O2|Outcome|Arm 2|Novantrone
541710|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541711|NCT00661492|O2|Outcome|Arm 2|Novantrone
541712|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541713|NCT00661492|O2|Outcome|Arm 2|Novantrone
541714|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541715|NCT00661492|O2|Outcome|Arm 2|Novantrone
541716|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541717|NCT00661492|O2|Outcome|Arm 2|Novantrone
541718|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
541719|NCT00661492|E2|Reported Event|Arm 2|Novantrone
541720|NCT00661492|E1|Reported Event|Arm 1|Novantrone+Erbitux
541721|NCT00661479|B5|Baseline|Total|Total of all reporting groups
541722|NCT00661479|B4|Baseline|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541723|NCT00661479|B3|Baseline|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541724|NCT00661479|B2|Baseline|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541725|NCT00661479|B1|Baseline|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541726|NCT00661479|P4|Participant Flow|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541727|NCT00661479|P3|Participant Flow|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541728|NCT00661479|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541729|NCT00661479|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541730|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541731|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541732|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541733|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541734|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541735|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541736|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541737|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541738|NCT00661479|E3|Reported Event|100 µg Brimonidine Tartrate Implant Groups A and B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541739|NCT00661479|E2|Reported Event|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541740|NCT00661479|E1|Reported Event|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
541741|NCT00661453|B1|Baseline|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
541742|NCT00661453|P1|Participant Flow|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
541743|NCT00661453|O1|Outcome|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
541744|NCT00661453|E1|Reported Event|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
541745|NCT00661427|B3|Baseline|Total|Total of all reporting groups
541746|NCT00661427|B2|Baseline|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
541747|NCT00661427|B1|Baseline|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
541748|NCT00661427|P2|Participant Flow|Cetuximab Infusion at 750 mg/m^2|Cetuximab infusion at 750 mg/m^2 over 3 hours every other week.
541749|NCT00661427|P1|Participant Flow|Cetuximab Infusion at 500 mg/m^2|Cetuximab infusion at 500 mg/m^2 over 2 hours every other week.
541757|NCT00661388|P1|Participant Flow|C.E.R.A|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).
541758|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541759|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541760|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541761|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541762|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541763|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541764|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541765|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541766|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541767|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541768|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541769|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541770|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541771|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541772|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541773|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541774|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541775|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541776|NCT00661388|E1|Reported Event|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
541777|NCT00661362|B3|Baseline|Total|Total of all reporting groups
541778|NCT00661362|B2|Baseline|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541779|NCT00661362|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541780|NCT00661362|P2|Participant Flow|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541781|NCT00661362|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541782|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541783|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541784|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541785|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541789|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541790|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541791|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541792|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541793|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541794|NCT00661362|E2|Reported Event|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
541795|NCT00661362|E1|Reported Event|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
541796|NCT00661258|B3|Baseline|Total|Total of all reporting groups
541797|NCT00661258|B2|Baseline|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
541798|NCT00661258|B1|Baseline|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
541799|NCT00661258|P2|Participant Flow|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
541800|NCT00661258|P1|Participant Flow|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
541801|NCT00661258|O2|Outcome|Control|The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for
541802|NCT00661258|O1|Outcome|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
541803|NCT00661258|O2|Outcome|Control|The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for
541804|NCT00661258|O1|Outcome|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
541805|NCT00661258|E2|Reported Event|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
541806|NCT00661258|E1|Reported Event|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
541807|NCT00661193|B3|Baseline|Total|Total of all reporting groups
541808|NCT00661193|B2|Baseline|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541809|NCT00661193|B1|Baseline|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541810|NCT00661193|P2|Participant Flow|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541811|NCT00661193|P1|Participant Flow|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541849|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541850|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541851|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541812|NCT00661193|O2|Outcome|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541813|NCT00661193|O1|Outcome|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541814|NCT00661193|O2|Outcome|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541815|NCT00661193|O1|Outcome|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541816|NCT00661193|E2|Reported Event|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541817|NCT00661193|E1|Reported Event|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
541818|NCT00661141|B4|Baseline|Total|Total of all reporting groups
541819|NCT00661141|B3|Baseline|Antizol 5.0 mg/kg and Placebo|Participants receive alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
541820|NCT00661141|B2|Baseline|Antizol 3.0 mg/kg and Placebo|Participants receive alternating study treatment (oral Antizol 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
541821|NCT00661141|B1|Baseline|Antizol 1.0 mg/kg and Placebo|Participants received alternating study treatment (oral Antizol 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
541822|NCT00661141|P6|Participant Flow|Placebo, Then Antizol 5.0 mg/kg|Participants received placebo treatment then Antizol 5.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
541823|NCT00661141|P5|Participant Flow|Antizol 5.0 mg/kg, Then Placebo|Participants received Antizol 5.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
541824|NCT00661141|P4|Participant Flow|Placebo, Then Antizol 3.0 mg/kg|Participants received placebo treatment then Antizol 3.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
541825|NCT00661141|P3|Participant Flow|Antizol 3.0 mg/kg, Then Placebo|Participants received Antizol 3.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
541826|NCT00661141|P2|Participant Flow|Placebo, Then Antizol 1.0 mg/kg|Participants received placebo treatment then Antizol 1.0 mg/kg on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
541827|NCT00661141|P1|Participant Flow|Antizol 1.0 mg/kg, Then Placebo|Participants received Antizol 1.0 mg/kg then placebo treatment on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
541828|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541829|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541830|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541831|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541832|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541833|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541834|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541835|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541836|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541837|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541838|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541839|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541840|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541841|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541842|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541843|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541844|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541845|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541846|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541847|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541848|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541852|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541853|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541854|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541855|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541856|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541857|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541858|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541859|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541860|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541861|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541862|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541863|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541864|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541865|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541866|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541867|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541868|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541869|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541870|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541871|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541872|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541873|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541874|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541875|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541876|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541877|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541878|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541879|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541880|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541881|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541882|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541883|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541884|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541885|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541886|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541887|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541888|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541889|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541890|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541891|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541892|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541893|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541894|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541895|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541896|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541897|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541898|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541899|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541900|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541901|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541902|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541903|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541904|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541905|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541906|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541907|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
542060|NCT00660985|P2|Participant Flow|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
541908|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541909|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541910|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541911|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541912|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541913|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541914|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541915|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541916|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541917|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541918|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541919|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541920|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541921|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541922|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541923|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541924|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541925|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541926|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541927|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541928|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541929|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541930|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541931|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541932|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541933|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541934|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541935|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541936|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541937|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541938|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541939|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541940|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541941|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541942|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541943|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541944|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541945|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541946|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541947|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541948|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541949|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541950|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541951|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541952|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541953|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541954|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541955|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541956|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541957|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541958|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541959|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541960|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541961|NCT00661141|O7|Outcome|Ethanol Followed by Placebo|Ethanol followed by placebo 30 minutes later.
541962|NCT00661141|O6|Outcome|Placebo Followed by Ethanol|Placebo followed by ethanol 30 minutes later.
541963|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
542061|NCT00660985|P1|Participant Flow|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
541964|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541965|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541966|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541967|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541968|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541969|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541970|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541971|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541972|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541973|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541974|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541975|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541976|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541977|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541978|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541979|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541980|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541981|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541982|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541983|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541984|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541985|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541986|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541987|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541988|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541989|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541990|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541991|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541992|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541993|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541994|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
541995|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
541996|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
541997|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
541998|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
541999|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
542000|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
542001|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
542002|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
542003|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
542004|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
542005|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
542006|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
542007|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
542008|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
542009|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
542010|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
542011|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
542012|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
542013|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
542014|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
542015|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
542016|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
542017|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
542018|NCT00661141|O5|Outcome|5.0 mg/kg Antizol Followed by Ethanol|5.0 mg/kg Antizol followed by ethanol 30 minutes later
542019|NCT00661141|O4|Outcome|Ethanol Followed by 3.0 mg/kg Antizol|Ethanol followed by 3.0 mg/kg Antizol 30 minutes later
542020|NCT00661141|O3|Outcome|3.0 mg/kg Antizol Followed by Ethanol|3.0 mg/kg Antizol followed by ethanol 30 minutes later
542021|NCT00661141|O2|Outcome|Ethanol Followed by 1.0 mg/kg Antizol|Ethanol followed by 1.0 mg/kg Antizol 30 minutes later
542022|NCT00661141|O1|Outcome|1.0 mg/kg Antizol Followed by Ethanol|1.0 mg/kg Antizol followed by ethanol 30 minutes later
542023|NCT00661141|O5|Outcome|Overall|Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
542024|NCT00661141|O4|Outcome|Pooled Placebo|Participants received placebo on either Study Day 1 or Study Day 2, administered 30 minutes prior to, or after, ethanol.
542025|NCT00661141|O3|Outcome|Antizol 5.0 mg/kg|Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
542026|NCT00661141|O2|Outcome|Antizol 3.0 mg/kg|Participants received alternating study treatment (oral Antizol 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
542027|NCT00661141|O1|Outcome|Antizol 1.0 mg/kg|Participants received alternating study treatment (oral Antizol 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
542028|NCT00661141|E5|Reported Event|Overall|Participants received alternating study treatment (oral Antizol 1.0, 3.0, or 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
542029|NCT00661141|E4|Reported Event|Pooled Placebo|Participants received placebo on either Study Day 1 or Study Day 2), administered 30 minutes prior to ethanol.
542030|NCT00661141|E3|Reported Event|Antizol 5.0 mg/kg|Participants received alternating study treatment (oral Antizol 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.
542031|NCT00661141|E2|Reported Event|Antizol 3.0 mg/kg|Participants received alternating study treatment (oral Antizol 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
542032|NCT00661141|E1|Reported Event|Antizol 1.0 mg/kg|Participants received alternating study treatment (oral Antizol 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol.
542033|NCT00661089|B3|Baseline|Total|Total of all reporting groups
542034|NCT00661089|B2|Baseline|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
542035|NCT00661089|B1|Baseline|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
542036|NCT00661089|P2|Participant Flow|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
542037|NCT00661089|P1|Participant Flow|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
542038|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
542039|NCT00661089|O1|Outcome|Placebo|Group received saline injections intramuscularly of equivalent volume
542040|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
542041|NCT00661089|O1|Outcome|Placebo|Group recieved saline injections intramuscularly of equivalent volume
542042|NCT00661089|E2|Reported Event|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
542043|NCT00661089|E1|Reported Event|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
542044|NCT00661037|B3|Baseline|Total|Total of all reporting groups
542045|NCT00661037|B2|Baseline|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542046|NCT00661037|B1|Baseline|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542047|NCT00661037|P2|Participant Flow|no VF Induction|"Patients not having VF induction at implant or during follow-up~Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock."
542048|NCT00661037|P1|Participant Flow|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542049|NCT00661037|O2|Outcome|No- VF Induction|Patients not having VF induction at implant or during follow-up
542050|NCT00661037|O1|Outcome|VF Induction|Patients having VF induction with shock termination at implant
542051|NCT00661037|O2|Outcome|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542052|NCT00661037|O1|Outcome|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542053|NCT00661037|O2|Outcome|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542054|NCT00661037|O1|Outcome|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542055|NCT00661037|E2|Reported Event|no VF Induction|Patients not having VF induction at implant or during follow-up (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542056|NCT00661037|E1|Reported Event|VF Induction|Patients having VF induction with shock termination at implant (Implantable defibrillator: Implantable defibrillator to reduce ventricular arrhythmias via shock)
542057|NCT00660985|B3|Baseline|Total|Total of all reporting groups
542058|NCT00660985|B2|Baseline|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
542059|NCT00660985|B1|Baseline|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
542070|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
542071|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
542072|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
542073|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
542074|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
542075|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
542076|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
542077|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
542078|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
542079|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
542080|NCT00660985|E2|Reported Event|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
542081|NCT00660985|E1|Reported Event|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
542082|NCT00660907|B3|Baseline|Total|Total of all reporting groups
542083|NCT00660907|B2|Baseline|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
542084|NCT00660907|B1|Baseline|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
542085|NCT00660907|P2|Participant Flow|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
542086|NCT00660907|P1|Participant Flow|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
542087|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
542088|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
542089|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
542090|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
542091|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
542092|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
542093|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
542094|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
542095|NCT00660907|E2|Reported Event|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
542096|NCT00660907|E1|Reported Event|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
542097|NCT00660829|B3|Baseline|Total|Total of all reporting groups
542098|NCT00660829|B2|Baseline|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542099|NCT00660829|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542100|NCT00660829|P2|Participant Flow|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542101|NCT00660829|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542102|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542103|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542104|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542105|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542106|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542107|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542108|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542109|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542110|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542111|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542112|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542113|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542114|NCT00660829|E2|Reported Event|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
542115|NCT00660829|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
542116|NCT00660816|B3|Baseline|Total|Total of all reporting groups
542117|NCT00660816|B2|Baseline|Experimental|Alimta or Taxotere and Tarceva
542118|NCT00660816|B1|Baseline|Active Comparator|Alimta or Taxotere alone
542119|NCT00660816|P2|Participant Flow|Experimental|Alimta or Taxotere and Tarceva
542120|NCT00660816|P1|Participant Flow|Active Comparator|Alimta or Taxotere alone
542121|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
542122|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
542123|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
542124|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
542125|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
542126|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
542127|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
542128|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
542129|NCT00660816|E2|Reported Event|Experimental|Alimta or Taxotere and Tarceva
542130|NCT00660816|E1|Reported Event|Active Comparator|Alimta or Taxotere alone
542200|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542201|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542202|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542203|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542204|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542131|NCT00660699|B1|Baseline|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542132|NCT00660699|P1|Participant Flow|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542133|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542134|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542135|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542136|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542137|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542138|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542139|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542140|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542141|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542142|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542205|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542206|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542143|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542144|NCT00660699|E1|Reported Event|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
542145|NCT00660660|B3|Baseline|Total|Total of all reporting groups
542146|NCT00660660|B2|Baseline|Placebo|Capsule once daily (QD)
542147|NCT00660660|B1|Baseline|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542148|NCT00660660|P2|Participant Flow|Placebo|Capsule once daily (QD)
542149|NCT00660660|P1|Participant Flow|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542150|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542151|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542152|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542153|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542154|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542155|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542156|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542157|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542158|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542159|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542160|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542161|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542162|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542163|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542164|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542165|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542166|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542167|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542168|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542169|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542170|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542171|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542172|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542173|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542174|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542175|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542176|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542177|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542178|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542179|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542180|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542181|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542182|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542183|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542184|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542185|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542186|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542187|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542188|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542189|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542190|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542191|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542192|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542193|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542194|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542195|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542196|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542197|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542198|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542199|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542207|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542208|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542209|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542210|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542211|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542212|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542213|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542214|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542215|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542216|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542217|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542218|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542219|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542220|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542221|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542222|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542223|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542224|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542225|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542226|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542227|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542228|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542229|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542230|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542231|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542232|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542233|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542234|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542235|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542236|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542237|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542238|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542239|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542240|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542241|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542242|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
542243|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542244|NCT00660660|E2|Reported Event|Placebo|Capsule once daily (QD)
542245|NCT00660660|E1|Reported Event|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
542246|NCT00660595|B3|Baseline|Total|Total of all reporting groups
542247|NCT00660595|B2|Baseline|Risperdal|Risperidone, oral administration
542248|NCT00660595|B1|Baseline|Seroquel|Quetiapine Prolong, oral administration
542249|NCT00660595|P2|Participant Flow|Risperdal|Risperidone, oral administration
542250|NCT00660595|P1|Participant Flow|Seroquel|Quetiapine Prolong, oral administration
542251|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
542252|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
542253|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
542254|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
542255|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
542256|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
542257|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
542258|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
542259|NCT00660595|E2|Reported Event|Risperdal|Risperidone, oral administration
542260|NCT00660595|E1|Reported Event|Seroquel|Quetiapine Prolong, oral administration
542261|NCT00660543|B1|Baseline|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
542262|NCT00660543|P1|Participant Flow|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
542263|NCT00660543|O1|Outcome|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).
542264|NCT00660543|O3|Outcome|Gadoteridol Leakage Correction|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
542265|NCT00660543|O2|Outcome|Gadoteridol|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
542479|NCT00660075|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
542266|NCT00660543|O1|Outcome|Ferumoxytol|Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
542267|NCT00660543|E3|Reported Event|Gadoteridol With Leakage Correction|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
542268|NCT00660543|E2|Reported Event|Gadoteridol|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
542269|NCT00660543|E1|Reported Event|Ferumoxytol|Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
542270|NCT00660517|B5|Baseline|Total|Total of all reporting groups
542271|NCT00660517|B4|Baseline|Placebo|nasal spray
542272|NCT00660517|B3|Baseline|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
542273|NCT00660517|B2|Baseline|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
542274|NCT00660517|B1|Baseline|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
542275|NCT00660517|P4|Participant Flow|Placebo|nasal spray
542276|NCT00660517|P3|Participant Flow|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
542277|NCT00660517|P2|Participant Flow|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
542278|NCT00660517|P1|Participant Flow|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
542279|NCT00660517|O4|Outcome|Placebo|nasal spray
542280|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
542281|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
542282|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
542283|NCT00660517|O4|Outcome|Placebo|placebo nasal spray one spray per nostril two times a day
542284|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
542285|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
542286|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
542287|NCT00660517|O4|Outcome|Placebo|nasal spray
542288|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
542289|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
542290|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
542291|NCT00660517|E4|Reported Event|Placebo|nasal spray
542292|NCT00660517|E3|Reported Event|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
542293|NCT00660517|E2|Reported Event|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
542294|NCT00660517|E1|Reported Event|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
542295|NCT00660504|B3|Baseline|Total|Total of all reporting groups
542296|NCT00660504|B2|Baseline|Etoposide, Anticancer, Injection|
542297|NCT00660504|B1|Baseline|Amrubicin, Anticancer, Injection|
542298|NCT00660504|P2|Participant Flow|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
542299|NCT00660504|P1|Participant Flow|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
542300|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
542301|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
542302|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
542303|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
542304|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
542305|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
542306|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
542307|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
542308|NCT00660504|E2|Reported Event|Etoposide, Anticancer, Injection|
542309|NCT00660504|E1|Reported Event|Amrubicin, Anticancer, Injection|
542310|NCT00660400|B1|Baseline|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
542311|NCT00660400|P1|Participant Flow|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
542312|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
542313|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
542314|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
542315|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
542316|NCT00660400|E1|Reported Event|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
542317|NCT00660387|B3|Baseline|Total|Total of all reporting groups
542318|NCT00660387|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542319|NCT00660387|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542320|NCT00660387|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542321|NCT00660387|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542322|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542323|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542324|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542325|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542326|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542327|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542328|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542329|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542330|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542331|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542332|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542333|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542334|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542335|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542380|NCT00660348|E1|Reported Event|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
542381|NCT00660309|B3|Baseline|Total|Total of all reporting groups
542336|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542337|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542338|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542339|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542340|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542341|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542342|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542343|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542344|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542345|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542346|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542347|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542348|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542349|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542350|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542351|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542352|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542353|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542354|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542355|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542356|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542357|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542358|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542359|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542360|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542361|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542362|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542363|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542364|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542365|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542366|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542367|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542368|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542369|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542370|NCT00660387|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
542371|NCT00660387|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
542372|NCT00660348|B3|Baseline|Total|Total of all reporting groups
542373|NCT00660348|B2|Baseline|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
542374|NCT00660348|B1|Baseline|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
542375|NCT00660348|P2|Participant Flow|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
542376|NCT00660348|P1|Participant Flow|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
542377|NCT00660348|O2|Outcome|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
542378|NCT00660348|O1|Outcome|Morphine|"morphine given traditionally (IV, pill, patch). This is standard of care dosing.~morphine sulfate: This is morphine given in the traditional methods."
542379|NCT00660348|E2|Reported Event|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
542477|NCT00660075|O1|Outcome|Placebo|Placebo for 6 weeks
542478|NCT00660075|E2|Reported Event|Placebo|Placebo for 6 weeks
542382|NCT00660309|B2|Baseline|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542383|NCT00660309|B1|Baseline|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542384|NCT00660309|P2|Participant Flow|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542385|NCT00660309|P1|Participant Flow|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542386|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542387|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542388|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542389|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542390|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542391|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542392|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542393|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542394|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542395|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542396|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542397|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542398|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542399|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542400|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542401|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542402|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542403|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542404|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542405|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542406|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542407|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542408|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542409|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542410|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542411|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542412|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542413|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542414|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542646|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542415|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542416|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542417|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542418|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542419|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542420|NCT00660309|E3|Reported Event|Irbesartan 300 mg|Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
542421|NCT00660309|E2|Reported Event|Aliskiren 300 mg|Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
542422|NCT00660309|E1|Reported Event|Captopril 25 mg|On Day 1 participants received a single oral dose of 25 mg captopril.
542423|NCT00660192|B3|Baseline|Total|Total of all reporting groups
542424|NCT00660192|B2|Baseline|Botox|
542425|NCT00660192|B1|Baseline|Placebo|
542426|NCT00660192|P2|Participant Flow|Botox|Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
542427|NCT00660192|P1|Participant Flow|Placebo|Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck.
542428|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
542429|NCT00660192|O1|Outcome|Placebo|Inactive Saline
542430|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
542431|NCT00660192|O1|Outcome|Placebo|Inactive Saline
542432|NCT00660192|E2|Reported Event|Botox|
542433|NCT00660192|E1|Reported Event|Saline|
542434|NCT00660179|B4|Baseline|Total|Total of all reporting groups
542435|NCT00660179|B3|Baseline|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542436|NCT00660179|B2|Baseline|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542437|NCT00660179|B1|Baseline|Placebo|Matching ACT-064992 placebo tablet, once daily
542438|NCT00660179|P3|Participant Flow|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542439|NCT00660179|P2|Participant Flow|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542440|NCT00660179|P1|Participant Flow|Placebo|Matching ACT-064992 placebo tablet, once daily
542441|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542442|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542443|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542444|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542445|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542446|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542447|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542448|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542449|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542450|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542451|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542452|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542453|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542454|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542455|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542456|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542457|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542458|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542459|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542460|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542461|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542462|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542463|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542464|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542465|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542466|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542467|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
542468|NCT00660179|E3|Reported Event|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
542469|NCT00660179|E2|Reported Event|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
542470|NCT00660179|E1|Reported Event|Placebo|Matching ACT-064992 placebo tablet, once daily
542471|NCT00660075|B3|Baseline|Total|Total of all reporting groups
542472|NCT00660075|B2|Baseline|Placebo|Placebo for 6 weeks
542473|NCT00660075|B1|Baseline|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
542474|NCT00660075|P2|Participant Flow|Sitagliptin First, Then Placebo|Participants were first administered Sitagliptin 100 mg/d for 6 weeks followed by a washout period of 4 weeks and were then switched over to placebo for 6 weeks.
542475|NCT00660075|P1|Participant Flow|Placebo First, Then Sitagliptin|Participants were first administered placebo for 6 weeks followed by a washout period of 4 weeks and were then switched over to Sitagliptin 100 mg/d for 6 weeks.
542476|NCT00660075|O2|Outcome|Sitagliptin 100 mg/d|Sitagliptin 100 mg/d for 6 weeks
542480|NCT00660049|B1|Baseline|Open Label Single Arm Study|Eligible participants
542481|NCT00660049|P1|Participant Flow|SNaP Application|"This is an open label pilot study of SMart Negative Pressure (SNaP) Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
542482|NCT00660049|O1|Outcome|Open Label Single Arm Study|All participants who use the device
542483|NCT00660049|E1|Reported Event|Eligible Participants|"This is an open label pilot study of SNaP Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
542484|NCT00660023|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542485|NCT00660023|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL).
542486|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542487|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542488|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542489|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542490|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542491|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542492|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542493|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542494|NCT00660023|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
542495|NCT00660010|B1|Baseline|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542496|NCT00660010|P1|Participant Flow|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542497|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542498|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542499|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542500|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542501|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542502|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542503|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542504|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542505|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542506|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542507|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542508|NCT00660010|E1|Reported Event|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
542509|NCT00659984|B1|Baseline|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Therapeutic dosing began at 12.0 mCi/kg and escalated to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
542510|NCT00659984|P1|Participant Flow|Ultratrace™ Iobenguane I 131|"Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 within 7 days (d) of enrollment, followed by 3 dosimetry scans over 3-6 days. For the imaging dose, 0.1 mCi/kg (3.7 MBq/kg), at a min dose of 1 mCi (37 MBq) but not to exceed 5 mCi (185 MBq) of Ultratrace™ Iobenguane I 131 was administered 7-28 d prior to the therapeutic dose on Day 0. If the imaging dose demonstrated NL biodistribution/tumor uptake, pts received a therapeutic dose within 7-28 d of the imaging dose followed by a single imaging scan on Day 7 post therapy.~Therapeutic dosing was to begin at 12.0 mCi/kg and escalate to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. Based on actual doses administered, pts were grouped into 3 mean dose groups: 11.2, 15.5, and 18.2 mCi/kg.~The dosimetry dose was administered over 1-3 mins by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused over 30 to 60 mins."
542511|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
542512|NCT00659984|O1|Outcome|Over Tumor Response|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
542513|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
542514|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Following therapeutic dosing at the 12.0, 15.0, and 18.0 mCi/kg cohorts, 4 patients who were to receive the 21.0 mCi/kg therapeutic dose were required to have their planned dose reduced below the dose that was calculated based on the patient’s dosimetry results, in order to meet the protocol guidelines for maximal dosage allowed to normal organs described above. Because of the differences between the planned and actual therapeutic doses that were administered to several patients, patients were grouped and the study data were presented and analyzed by actual doses rather than by the planned dose cohorts of 12.0, 15.0, 18.0, and 21.0 mCi/kg. Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
542515|NCT00659984|O3|Outcome|18.2 mCi Group|18.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
542516|NCT00659984|O2|Outcome|15.5 mCi Group|15.5 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
542517|NCT00659984|O1|Outcome|11.2 mCi Group|11.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
542518|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Following therapeutic dosing at the 12.0, 15.0, and 18.0 mCi/kg cohorts, 4 patients who were to receive the 21.0 mCi/kg therapeutic dose were required to have their planned dose reduced below the dose that was calculated based on the patient’s dosimetry results, in order to meet the protocol guidelines for maximal dosage allowed to normal organs described above. Because of the differences between the planned and actual therapeutic doses that were administered to several patients, patients were grouped and the study data were presented and analyzed by actual doses rather than by the planned dose cohorts of 12.0, 15.0, 18.0, and 21.0 mCi/kg. Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
542647|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542648|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542519|NCT00659984|E1|Reported Event|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Mean therapeutic dosing groups were 11.2 mCi/kg, 15.5 nCi/kg and 18.2 mCi/kg. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
542520|NCT00659945|B3|Baseline|Total|Total of all reporting groups
542521|NCT00659945|B2|Baseline|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
542522|NCT00659945|B1|Baseline|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
542523|NCT00659945|P2|Participant Flow|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
542524|NCT00659945|P1|Participant Flow|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
542525|NCT00659945|O2|Outcome|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
542526|NCT00659945|O1|Outcome|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
542527|NCT00659945|E2|Reported Event|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
542528|NCT00659945|E1|Reported Event|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
542529|NCT00659880|B1|Baseline|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
542530|NCT00659880|P1|Participant Flow|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
542531|NCT00659880|O1|Outcome|Meniscal Allograft Integration|The MRI were assessed for the integration of the posterior and anterior horns as well as the body of the meniscus.
542532|NCT00659880|O1|Outcome|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
542533|NCT00659880|E1|Reported Event|Meniscal Allograft Transplant|Patients who received a BioCeanse Meniscal Allograft Transplant
542534|NCT00659815|B3|Baseline|Total|Total of all reporting groups
542535|NCT00659815|B2|Baseline|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
542536|NCT00659815|B1|Baseline|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
542537|NCT00659815|P2|Participant Flow|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
542538|NCT00659815|P1|Participant Flow|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
542539|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
542540|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
542541|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
542542|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
542543|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
542544|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
542545|NCT00659815|E2|Reported Event|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
542546|NCT00659815|E1|Reported Event|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
542547|NCT00659789|B3|Baseline|Total|Total of all reporting groups
542548|NCT00659789|B2|Baseline|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542549|NCT00659789|B1|Baseline|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542550|NCT00659789|P2|Participant Flow|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542551|NCT00659789|P1|Participant Flow|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542552|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542553|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542554|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542555|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542556|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542649|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542557|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542558|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542559|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542560|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542561|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542562|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542563|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542564|NCT00659789|E2|Reported Event|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
542565|NCT00659789|E1|Reported Event|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
542566|NCT00659737|B3|Baseline|Total|Total of all reporting groups
542567|NCT00659737|B2|Baseline|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
542568|NCT00659737|B1|Baseline|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
542569|NCT00659737|P2|Participant Flow|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure.
542570|NCT00659737|P1|Participant Flow|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
542571|NCT00659737|O2|Outcome|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
542572|NCT00659737|O1|Outcome|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
542573|NCT00659737|E2|Reported Event|Scopolamine|"Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.~Scopolamine + Emend (Aprepitant): 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days"
542574|NCT00659737|E1|Reported Event|Aprepiatnt|"Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.~Emend (Aprepitant) + Placebo: 40mg tablet"
542575|NCT00659724|B1|Baseline|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
542576|NCT00659724|P1|Participant Flow|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
542577|NCT00659724|O3|Outcome|Optiflux F200NR|
542578|NCT00659724|O2|Outcome|Optiflux F180NR|
542579|NCT00659724|O1|Outcome|Revaclear MAX|
542580|NCT00659724|O3|Outcome|Optiflux F200NR|
542581|NCT00659724|O2|Outcome|Optiflux F180NR|
542582|NCT00659724|O1|Outcome|Revaclear MAX|
542583|NCT00659724|O3|Outcome|Optiflux F200NR|
542584|NCT00659724|O2|Outcome|Optiflux F180NR|
542585|NCT00659724|O1|Outcome|Revaclear MAX|
542586|NCT00659724|O3|Outcome|Optiflux F200NR|
542587|NCT00659724|O2|Outcome|Optiflux F180NR|
542588|NCT00659724|O1|Outcome|Revaclear MAX|
542589|NCT00659724|O3|Outcome|Optiflux F200NR|
542590|NCT00659724|O2|Outcome|Optiflux F180NR|
542591|NCT00659724|O1|Outcome|Revaclear MAX|
542592|NCT00659724|E1|Reported Event|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
542593|NCT00659633|B1|Baseline|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
542594|NCT00659633|P1|Participant Flow|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
542595|NCT00659633|O1|Outcome|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
542596|NCT00659633|E1|Reported Event|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
542597|NCT00659607|B1|Baseline|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542598|NCT00659607|P1|Participant Flow|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542599|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
542600|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
542650|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542601|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542602|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542603|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542604|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542605|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542606|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542607|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542608|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542609|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542610|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542611|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542612|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542613|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
542614|NCT00659607|E1|Reported Event|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
542615|NCT00659581|B1|Baseline|Telmisartan|
542616|NCT00659581|P1|Participant Flow|Telmisartan|
542617|NCT00659581|O1|Outcome|Telmisartan|
542618|NCT00659581|O1|Outcome|Telmisartan|
542619|NCT00659581|O1|Outcome|Telmisartan|
542620|NCT00659581|O1|Outcome|Telmisartan|
542621|NCT00659581|O1|Outcome|Telmisartan|
542622|NCT00659581|O1|Outcome|Telmisartan|
542623|NCT00659581|O1|Outcome|Telmisartan|
542624|NCT00659581|O1|Outcome|Telmisartan|
542625|NCT00659581|O1|Outcome|Telmisartan|
542626|NCT00659581|E1|Reported Event|Telmisartan|
542627|NCT00659529|B1|Baseline|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
542628|NCT00659529|P1|Participant Flow|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
542629|NCT00659529|O1|Outcome|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
542630|NCT00659529|E1|Reported Event|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
542631|NCT00659490|B4|Baseline|Total|Total of all reporting groups
542632|NCT00659490|B3|Baseline|Naproxen|Naproxen 500mg given pre-surgery
542633|NCT00659490|B2|Baseline|Placebo|Placebo given pre-surgery
542634|NCT00659490|B1|Baseline|AZD1940|AZD1940 800ug given predose
542635|NCT00659490|P3|Participant Flow|Naproxen|Naproxen 500mg given pre-surgery
542636|NCT00659490|P2|Participant Flow|Placebo|Placebo given pre-surgery
542637|NCT00659490|P1|Participant Flow|AZD1940|AZD1940 800ug given predose
542638|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542639|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542640|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542641|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542642|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542643|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542644|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542645|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542680|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542681|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542682|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542683|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542684|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542685|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542686|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542687|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542688|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542689|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542690|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542691|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542692|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542693|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542694|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542695|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542696|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542697|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542698|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542699|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542700|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542701|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
542702|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
542703|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
542704|NCT00659490|E3|Reported Event|Naproxen|Naproxen 500mg given pre-surgery
542705|NCT00659490|E2|Reported Event|Placebo|Placebo given pre-surgery
542706|NCT00659490|E1|Reported Event|AZD1940|AZD1940 800ug given predose
542707|NCT00659438|B3|Baseline|Total|Total of all reporting groups
542708|NCT00659438|B2|Baseline|Placebo|Bicalutamide 150mg + placebo
542709|NCT00659438|B1|Baseline|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542710|NCT00659438|P2|Participant Flow|Placebo|Bicalutamide 150mg + placebo
542711|NCT00659438|P1|Participant Flow|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542712|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542713|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542714|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542715|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542716|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542717|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542718|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542719|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542720|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542721|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542722|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542723|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542724|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542725|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542726|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542727|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542728|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
542729|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542730|NCT00659438|E2|Reported Event|Placebo|Bicalutamide 150mg + placebo
542731|NCT00659438|E1|Reported Event|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
542732|NCT00659425|B11|Baseline|Total|Total of all reporting groups
542733|NCT00659425|B10|Baseline|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542734|NCT00659425|B9|Baseline|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542735|NCT00659425|B8|Baseline|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542736|NCT00659425|B7|Baseline|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542737|NCT00659425|B6|Baseline|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542738|NCT00659425|B5|Baseline|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542739|NCT00659425|B4|Baseline|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542740|NCT00659425|B3|Baseline|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542741|NCT00659425|B2|Baseline|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542742|NCT00659425|B1|Baseline|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542743|NCT00659425|P10|Participant Flow|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542744|NCT00659425|P9|Participant Flow|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542745|NCT00659425|P8|Participant Flow|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542746|NCT00659425|P7|Participant Flow|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542747|NCT00659425|P6|Participant Flow|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542748|NCT00659425|P5|Participant Flow|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542749|NCT00659425|P4|Participant Flow|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542750|NCT00659425|P3|Participant Flow|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542751|NCT00659425|P2|Participant Flow|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542752|NCT00659425|P1|Participant Flow|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542753|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542754|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542755|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542756|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542757|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542758|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542759|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542760|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542761|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542762|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542763|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542764|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542765|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542766|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542767|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542768|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542769|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542770|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542771|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542772|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542773|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542774|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542775|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542776|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542777|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542778|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542779|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542780|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542781|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542782|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542783|NCT00659425|O7|Outcome|50 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542784|NCT00659425|O6|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542785|NCT00659425|O5|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542786|NCT00659425|O4|Outcome|30 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542787|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542788|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542789|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542790|NCT00659425|O7|Outcome|50 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542791|NCT00659425|O6|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542792|NCT00659425|O5|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542793|NCT00659425|O4|Outcome|30 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
543015|NCT00659334|O4|Outcome|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
542794|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542795|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542796|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542797|NCT00659425|O7|Outcome|50 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542798|NCT00659425|O6|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542799|NCT00659425|O5|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542800|NCT00659425|O4|Outcome|30 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542801|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542802|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542803|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542804|NCT00659425|O7|Outcome|50 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 50 mcg/kg CAT-8015 without concomitant corticosteroid administration/continuous every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542805|NCT00659425|O6|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542806|NCT00659425|O5|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542807|NCT00659425|O4|Outcome|30 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 30 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542808|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 20 mcg/kg CAT-8015 with/without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542809|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542810|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542811|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542812|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542813|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542814|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542815|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542816|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542817|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542818|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542819|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
543016|NCT00659334|O3|Outcome|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
550484|NCT00636610|B3|Baseline|Total|Total of all reporting groups
542820|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542821|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542822|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542823|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542824|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542825|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542826|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542827|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542828|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542829|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542830|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542831|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542832|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542833|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542834|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542835|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542836|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542837|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542838|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542839|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542840|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542841|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542842|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542843|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542844|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542845|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
543404|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
542846|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542847|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542848|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542849|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542850|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542851|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542852|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542853|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542854|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542855|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542856|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542857|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542858|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542859|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542860|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542861|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542862|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542863|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542864|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542865|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542866|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542867|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542868|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542869|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542870|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542871|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
543488|NCT00658411|B1|Baseline|All Patients|Deferoxamine prior to stem cells
542872|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542873|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542874|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542875|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542876|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542877|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542878|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542879|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542880|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542881|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542882|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542883|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542884|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542885|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542886|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542887|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542888|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542889|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542890|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542891|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542892|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542893|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542894|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542895|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542896|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542897|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
558176|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
542898|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542899|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542900|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542901|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542902|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542903|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542904|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542905|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542906|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542907|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542908|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542909|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542910|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542911|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542912|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542913|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542914|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542915|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542916|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542917|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542918|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542919|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542920|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542921|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542922|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542923|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
543017|NCT00659334|O2|Outcome|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
542924|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542925|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542926|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542927|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542928|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542929|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542930|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542931|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542932|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542933|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542934|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542935|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542936|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542937|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542938|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542939|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542940|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542941|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542942|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542943|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542944|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542945|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542946|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542947|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542948|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542949|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
560322|NCT00614406|B3|Baseline|Total|Total of all reporting groups
542950|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542951|NCT00659425|O10|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542952|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542953|NCT00659425|O8|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542954|NCT00659425|O7|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542955|NCT00659425|O6|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542956|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542957|NCT00659425|O4|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542958|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542959|NCT00659425|O2|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542960|NCT00659425|O1|Outcome|5 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542961|NCT00659425|O9|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542962|NCT00659425|O8|Outcome|50 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542963|NCT00659425|O7|Outcome|32 Microgram Per Kilogram (mcg/kg): Schema C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542964|NCT00659425|O6|Outcome|40 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542965|NCT00659425|O5|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542966|NCT00659425|O4|Outcome|30 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542967|NCT00659425|O3|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542968|NCT00659425|O2|Outcome|20 Microgram Per Kilogram (mcg/kg): Schema A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542969|NCT00659425|O1|Outcome|10 Microgram Per Kilogram (mcg/kg)|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542970|NCT00659425|E10|Reported Event|50 UG/KG SCHEMA C|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) continuous every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542971|NCT00659425|E9|Reported Event|50 UG/KG SCHEMA B|Participants received intravenous infusion of 50 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542972|NCT00659425|E8|Reported Event|32 UG/KG SCHEMA C|Participants received intravenous infusion of 32 mcg/kg moxetumomab pasudotox (CAT-8015) of process 3 material every other day (QoD) in a 21-day cycle for a total of 10 doses per cycle.
542973|NCT00659425|E7|Reported Event|40 UG/KG SCHEMA B|Participants received intravenous infusion of 40 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542974|NCT00659425|E6|Reported Event|30 UG/KG SCHEMA B|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542975|NCT00659425|E5|Reported Event|30 UG/KG SCHEMA A|Participants received intravenous infusion of 30 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
543018|NCT00659334|O1|Outcome|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
560427|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
542976|NCT00659425|E4|Reported Event|20 UG/KG SCHEMA B|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) with concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542977|NCT00659425|E3|Reported Event|20 UG/KG SCHEMA A|Participants received intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542978|NCT00659425|E2|Reported Event|10 UG/KG SCHEMA A|Participants received intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542979|NCT00659425|E1|Reported Event|5 UG/KG SCHEMA A|Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day cycle for a total of 6 doses per cycle.
542980|NCT00659373|B3|Baseline|Total|Total of all reporting groups
542981|NCT00659373|B2|Baseline|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation).~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
542982|NCT00659373|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
542983|NCT00659373|P2|Participant Flow|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
542984|NCT00659373|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
542985|NCT00659373|O2|Outcome|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
542986|NCT00659373|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
542987|NCT00659373|E2|Reported Event|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
542988|NCT00659373|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
542989|NCT00659360|B1|Baseline|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542990|NCT00659360|P1|Participant Flow|Arm I AZD0530|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542991|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542992|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542993|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542994|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542995|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542996|NCT00659360|E1|Reported Event|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
542997|NCT00659334|B8|Baseline|Total|Total of all reporting groups
542998|NCT00659334|B7|Baseline|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
542999|NCT00659334|B6|Baseline|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
543000|NCT00659334|B5|Baseline|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
543001|NCT00659334|B4|Baseline|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
543002|NCT00659334|B3|Baseline|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
543003|NCT00659334|B2|Baseline|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
543004|NCT00659334|B1|Baseline|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
543005|NCT00659334|P7|Participant Flow|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
543006|NCT00659334|P6|Participant Flow|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
543007|NCT00659334|P5|Participant Flow|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
543008|NCT00659334|P4|Participant Flow|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
543009|NCT00659334|P3|Participant Flow|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
543010|NCT00659334|P2|Participant Flow|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
543011|NCT00659334|P1|Participant Flow|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
543012|NCT00659334|O7|Outcome|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
543013|NCT00659334|O6|Outcome|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
543014|NCT00659334|O5|Outcome|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
543019|NCT00659334|E7|Reported Event|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
543020|NCT00659334|E6|Reported Event|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
543021|NCT00659334|E5|Reported Event|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
543022|NCT00659334|E4|Reported Event|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
543023|NCT00659334|E3|Reported Event|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
543024|NCT00659334|E2|Reported Event|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
543025|NCT00659334|E1|Reported Event|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
543026|NCT00659295|B3|Baseline|Total|Total of all reporting groups
543027|NCT00659295|B2|Baseline|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543028|NCT00659295|B1|Baseline|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543029|NCT00659295|P2|Participant Flow|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543030|NCT00659295|P1|Participant Flow|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543031|NCT00659295|O2|Outcome|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543032|NCT00659295|O1|Outcome|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543033|NCT00659295|E2|Reported Event|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543034|NCT00659295|E1|Reported Event|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
543035|NCT00659269|B3|Baseline|Total|Total of all reporting groups
543036|NCT00659269|B2|Baseline|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
543037|NCT00659269|B1|Baseline|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
543038|NCT00659269|P2|Participant Flow|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
543039|NCT00659269|P1|Participant Flow|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
543040|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543099|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543157|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543041|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543042|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543043|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543044|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
543045|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, abraxane, 1200-1800"
543046|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543047|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543048|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543049|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543050|NCT00659269|O2|Outcome|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
543051|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
543100|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543052|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543053|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543054|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543055|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543056|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
543057|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
543058|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543059|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
543060|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543061|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
543062|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400"
543063|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
543064|NCT00659269|E2|Reported Event|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
543065|NCT00659269|E1|Reported Event|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
543066|NCT00659230|B3|Baseline|Total|Total of all reporting groups
543067|NCT00659230|B2|Baseline|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
543068|NCT00659230|B1|Baseline|Placebo|"Arm 1~Placebo: 100-800mg placebo"
543069|NCT00659230|P2|Participant Flow|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
543070|NCT00659230|P1|Participant Flow|Placebo|"Arm 1~Placebo: 100-800mg placebo"
543071|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
543072|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
543073|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
543074|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
543075|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
543076|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
543077|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
543078|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
543079|NCT00659230|E2|Reported Event|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
543080|NCT00659230|E1|Reported Event|Placebo|"Arm 1~Placebo: 100-800mg placebo"
543081|NCT00659165|B3|Baseline|Total|Total of all reporting groups
543082|NCT00659165|B2|Baseline|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543083|NCT00659165|B1|Baseline|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543084|NCT00659165|P2|Participant Flow|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543085|NCT00659165|P1|Participant Flow|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543086|NCT00659165|O2|Outcome|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543087|NCT00659165|O1|Outcome|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543088|NCT00659165|E2|Reported Event|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543089|NCT00659165|E1|Reported Event|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
543090|NCT00659061|B3|Baseline|Total|Total of all reporting groups
543091|NCT00659061|B2|Baseline|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543092|NCT00659061|B1|Baseline|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543093|NCT00659061|P2|Participant Flow|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543094|NCT00659061|P1|Participant Flow|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543095|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543096|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543097|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543098|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543234|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
543101|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543102|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543103|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543104|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543105|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543106|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543107|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543108|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543109|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543110|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
543111|NCT00658996|B1|Baseline|Entire Study Population|Population enrolled at start of study
543112|NCT00658996|P2|Participant Flow|Focus Dailies Toric First, Then SofLens DD Toric|Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
543113|NCT00658996|P1|Participant Flow|SofLens DD Toric First, Then Focus Dailies Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens
543114|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
543115|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
543116|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
543117|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
543118|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
543119|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
543120|NCT00658996|E2|Reported Event|Ciba Vision Toric Lens|Ciba Vision Focus Dailies Toric Lens
543121|NCT00658996|E1|Reported Event|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
543122|NCT00658814|B3|Baseline|Total|Total of all reporting groups
543123|NCT00658814|B2|Baseline|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543124|NCT00658814|B1|Baseline|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543125|NCT00658814|P2|Participant Flow|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543126|NCT00658814|P1|Participant Flow|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543127|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543285|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543128|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543129|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543130|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543131|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543132|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
543133|NCT00658814|O3|Outcome|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
543134|NCT00658814|O2|Outcome|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
543135|NCT00658814|O1|Outcome|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
543136|NCT00658814|E3|Reported Event|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
543137|NCT00658814|E2|Reported Event|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
543138|NCT00658814|E1|Reported Event|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
543139|NCT00658788|B1|Baseline|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
543140|NCT00658788|P1|Participant Flow|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
543141|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543142|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543143|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543144|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543145|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543146|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543147|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543148|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543149|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543150|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543151|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543152|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543153|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543154|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543155|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543156|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543158|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543159|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543160|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543161|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543162|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543163|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543164|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543165|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543166|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543167|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543168|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543169|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543170|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543171|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543172|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543173|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543174|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543175|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543176|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543177|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543178|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543179|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543180|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543181|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543182|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543183|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543184|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543185|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543186|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543187|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543188|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543189|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
543190|NCT00658788|O1|Outcome|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
543191|NCT00658788|E1|Reported Event|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
543192|NCT00658775|B3|Baseline|Total|Total of all reporting groups
543193|NCT00658775|B2|Baseline|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
543194|NCT00658775|B1|Baseline|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
543195|NCT00658775|P2|Participant Flow|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
543286|NCT00658684|O1|Outcome|Total|All subjects
543196|NCT00658775|P1|Participant Flow|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
543197|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
543198|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
543199|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
543200|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
543201|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
543202|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
543203|NCT00658775|E2|Reported Event|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
543204|NCT00658775|E1|Reported Event|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
543205|NCT00658736|B3|Baseline|Total|Total of all reporting groups
543206|NCT00658736|B2|Baseline|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
543207|NCT00658736|B1|Baseline|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
543208|NCT00658736|P2|Participant Flow|Bupivicaine Plus Triamcinolone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution mixed with 80 mg Triamcinolone.
543209|NCT00658736|P1|Participant Flow|Bupivicaine Alone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution.
543210|NCT00658736|O2|Outcome|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
543211|NCT00658736|O1|Outcome|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
543212|NCT00658736|O2|Outcome|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
543213|NCT00658736|O1|Outcome|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
543214|NCT00658736|E2|Reported Event|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
543215|NCT00658736|E1|Reported Event|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
543216|NCT00658723|B3|Baseline|Total|Total of all reporting groups
543217|NCT00658723|B2|Baseline|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
543218|NCT00658723|B1|Baseline|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
543219|NCT00658723|P3|Participant Flow|Fibrin Pad Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). (Non - Randomized)
543220|NCT00658723|P2|Participant Flow|SURGICEL™ Randomized|"SURGICEL™ Absorbable Hemostat~SURGICEL™: Absorbable hemostat"
543221|NCT00658723|P1|Participant Flow|Fibrin Pad Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543222|NCT00658723|O2|Outcome|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
543223|NCT00658723|O1|Outcome|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
543224|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
543225|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
543226|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543227|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
543228|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
543229|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543230|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
543231|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
543232|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543233|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
543235|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543236|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
543237|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
543238|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543239|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
543240|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
543241|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543242|NCT00658723|O3|Outcome|Fibrin Pad - Non-Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
543243|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
543244|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
543245|NCT00658723|E2|Reported Event|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
543246|NCT00658723|E1|Reported Event|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
543247|NCT00658697|B1|Baseline|Docetaxel, Bevacizumab, and Androgen Deprivation Therapy (ADT)|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~Androgen deprivation therapy (ADT) or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543248|NCT00658697|P1|Participant Flow|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543249|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543250|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543251|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543287|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543288|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543289|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543290|NCT00658684|O1|Outcome|Total|All subjects
543252|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543253|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543254|NCT00658697|E1|Reported Event|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
543255|NCT00658684|B4|Baseline|Total|Total of all reporting groups
543256|NCT00658684|B3|Baseline|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543257|NCT00658684|B2|Baseline|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543258|NCT00658684|B1|Baseline|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543259|NCT00658684|P4|Participant Flow|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543260|NCT00658684|P3|Participant Flow|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543261|NCT00658684|P2|Participant Flow|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543262|NCT00658684|P1|Participant Flow|Total|All subjects
543263|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543264|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543265|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543266|NCT00658684|O1|Outcome|Total|All subjects
543267|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543268|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543269|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543270|NCT00658684|O1|Outcome|Total|All subjects
543271|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543272|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543273|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543274|NCT00658684|O1|Outcome|Total|All subjects
543275|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543276|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543277|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543278|NCT00658684|O1|Outcome|Total|All subjects
543279|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543280|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543281|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543282|NCT00658684|O1|Outcome|Total|All subjects
543283|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543284|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543291|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543292|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543293|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543294|NCT00658684|O1|Outcome|Total|All subjects
543295|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543296|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543297|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543298|NCT00658684|O1|Outcome|Total|All subjects
543299|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543300|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543301|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543302|NCT00658684|O1|Outcome|Total|All subjects
543303|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543304|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543305|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543306|NCT00658684|O1|Outcome|Total|All subjects
543307|NCT00658684|E4|Reported Event|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
543308|NCT00658684|E3|Reported Event|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
543309|NCT00658684|E2|Reported Event|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
543310|NCT00658684|E1|Reported Event|Total|All subjects
543311|NCT00658658|B6|Baseline|Total|Total of all reporting groups
543312|NCT00658658|B5|Baseline|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543313|NCT00658658|B4|Baseline|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543314|NCT00658658|B3|Baseline|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543315|NCT00658658|B2|Baseline|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543316|NCT00658658|B1|Baseline|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543317|NCT00658658|P5|Participant Flow|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543318|NCT00658658|P4|Participant Flow|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543319|NCT00658658|P3|Participant Flow|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543320|NCT00658658|P2|Participant Flow|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543321|NCT00658658|P1|Participant Flow|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543322|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543323|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543401|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
543324|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543325|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543326|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543327|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543328|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543329|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543330|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543331|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543332|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543333|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543334|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543335|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543336|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543337|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543338|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543339|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543340|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543341|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543342|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543343|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543344|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543345|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543402|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
543346|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543347|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543348|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543349|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543350|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543351|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543352|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543353|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543354|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543355|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543356|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543357|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543358|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543359|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543360|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543361|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543362|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543363|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543364|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543365|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543366|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543367|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543403|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543368|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543369|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543370|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543371|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543372|NCT00658658|E5|Reported Event|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543373|NCT00658658|E4|Reported Event|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543374|NCT00658658|E3|Reported Event|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543375|NCT00658658|E2|Reported Event|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543376|NCT00658658|E1|Reported Event|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
543377|NCT00658632|B3|Baseline|Total|Total of all reporting groups
543378|NCT00658632|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543379|NCT00658632|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543380|NCT00658632|P2|Participant Flow|Rabeprazole (RAB) Extended Release (ER) 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543381|NCT00658632|P1|Participant Flow|Esomeprazole (ESO) 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543382|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543383|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543384|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543385|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543386|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543387|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543388|NCT00658632|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543389|NCT00658632|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543390|NCT00658619|B6|Baseline|Total|Total of all reporting groups
543391|NCT00658619|B5|Baseline|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
543392|NCT00658619|B4|Baseline|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543393|NCT00658619|B3|Baseline|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543394|NCT00658619|B2|Baseline|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543395|NCT00658619|B1|Baseline|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543396|NCT00658619|P5|Participant Flow|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
543397|NCT00658619|P4|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543398|NCT00658619|P3|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543399|NCT00658619|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543400|NCT00658619|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543405|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
543406|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543407|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
543408|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
543409|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543410|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
543411|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
543412|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543413|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
543414|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543415|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543416|NCT00658619|E3|Reported Event|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
543417|NCT00658619|E2|Reported Event|200 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543418|NCT00658619|E1|Reported Event|400 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
543419|NCT00658606|B3|Baseline|Total|Total of all reporting groups
543420|NCT00658606|B2|Baseline|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543421|NCT00658606|B1|Baseline|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543422|NCT00658606|P2|Participant Flow|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543423|NCT00658606|P1|Participant Flow|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543424|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543425|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543426|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543427|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543428|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543429|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543430|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543431|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543432|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543433|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543434|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543435|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543436|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543437|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543438|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543439|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543440|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543441|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543442|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543443|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543444|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543445|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543446|NCT00658606|E2|Reported Event|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
543447|NCT00658606|E1|Reported Event|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
543448|NCT00658567|B4|Baseline|Total|Total of all reporting groups
543449|NCT00658567|B3|Baseline|20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
543450|NCT00658567|B2|Baseline|10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
543451|NCT00658567|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
543452|NCT00658567|P3|Participant Flow|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
543453|NCT00658567|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
543454|NCT00658567|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
543455|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
543456|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
543457|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
543458|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
543459|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
543460|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
543461|NCT00658567|E3|Reported Event|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
543462|NCT00658567|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
543463|NCT00658567|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
543464|NCT00658541|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
543465|NCT00658541|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
543466|NCT00658541|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 following an an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
543467|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
543468|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
543469|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
543470|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
543471|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
543472|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
543473|NCT00658541|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
543474|NCT00658541|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
543475|NCT00658528|B3|Baseline|Total|Total of all reporting groups
543476|NCT00658528|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543477|NCT00658528|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543478|NCT00658528|P2|Participant Flow|RAB ER 50 mg|Rabeprazole (RAB) Extended Release (ER) 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543479|NCT00658528|P1|Participant Flow|ESO 40 mg|Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks.
543480|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543481|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543482|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543483|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543484|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543485|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543486|NCT00658528|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
543487|NCT00658528|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
543489|NCT00658411|P1|Participant Flow|All Patients|Deferoxamine for >= 2 weeks prior to stem cells
543490|NCT00658411|O4|Outcome|Overall Survival (Deferoxamine)|Patients who received Deferoxamine and have relapsed and is alive at 1 year.
543491|NCT00658411|O3|Outcome|Disease-Free Survival (Deferoxamine)|Patients who received Deferoxamine and are currently alive without incidence of relapse at 1 year.
543492|NCT00658411|O2|Outcome|Relapse (Deferoxamine)|Patients who received Deferoxamine and relapsed post transplant at 1 year.
543493|NCT00658411|O1|Outcome|Transplant-Related Mortality (Deferoxamine)|Patients who received Deferoxamine and passed away as a result of transplant or study treatment without prior relapse at 1 year.
543494|NCT00658411|O1|Outcome|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
543495|NCT00658411|E1|Reported Event|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
543496|NCT00658385|B1|Baseline|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
543497|NCT00658385|P1|Participant Flow|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
543498|NCT00658385|O1|Outcome|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
543499|NCT00658385|E1|Reported Event|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
543500|NCT00658359|B4|Baseline|Total|Total of all reporting groups
543501|NCT00658359|B3|Baseline|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543502|NCT00658359|B2|Baseline|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543503|NCT00658359|B1|Baseline|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543504|NCT00658359|P3|Participant Flow|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
544400|NCT00655083|P1|Participant Flow|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
543505|NCT00658359|P2|Participant Flow|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543506|NCT00658359|P1|Participant Flow|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543507|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543508|NCT00658359|O2|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543509|NCT00658359|O1|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543510|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543511|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543512|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543513|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543514|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543515|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543516|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543517|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543518|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543519|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543520|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543521|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543522|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543523|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543524|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543525|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543607|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
544401|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
543526|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543527|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543528|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543529|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543530|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543531|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543532|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543533|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543534|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543535|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543536|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543537|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543538|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543539|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543540|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543541|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543542|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543543|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543544|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543545|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543546|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543618|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
544402|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
543547|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543548|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543549|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543550|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543551|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543552|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543553|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543554|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543555|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543556|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543557|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543558|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543559|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543560|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543561|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543562|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543563|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543564|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543565|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543566|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543567|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543665|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543666|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543667|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection fo rMenB+OMV NZ (Lot1, or Lot 2, or Lot 3) at 2, 4, and 6months of age concomitantly with the routinely administered infant vaccines.
544403|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
543568|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543569|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543570|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543571|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543572|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543573|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543574|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543575|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543576|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543577|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543578|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543579|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543580|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543581|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543582|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543583|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543584|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543585|NCT00658359|O3|Outcome|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543586|NCT00658359|O2|Outcome|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543587|NCT00658359|O1|Outcome|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543588|NCT00658359|E3|Reported Event|Tofacitinib More Intensive (MI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 mg tablet orally BID for Months 1 to 6 posttransplant then 10 mg tablet orally BID from Month 7. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib MI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543668|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543669|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543670|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543589|NCT00658359|E2|Reported Event|Tofacitinib Less Intensive (LI)|Tofacitinib was administered for up to 60 months. During the parent study (A3921030), participants received 15 milligram (mg) tablet orally BID for Months 1 to 3 posttransplant then 10 mg tablet orally BID from Month 4. On entry to this extension study (Month 12), the dose was continued and tapered to 5 mg BID as early as Month 12 and by Month 18 posttransplant. Total tofacitinib LI treatment was up to 72 months posttransplant (12 months parent study and 60 months extension). Participants also received oral MMF 1 to 2 gram tablet daily throughout this extension study. Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543590|NCT00658359|E1|Reported Event|Cyclosporine|CsA was administered for up to 60 months as CsA microemulsion (Neoral® brand in the United States) orally twice daily (BID) in 2 equal doses approximately 12 hours apart. The dosage was adjusted to achieve a 12 hour trough whole blood level of approximately 75 to 200 nanograms per milliliter (ng/mL). Participants also received oral mycophenolate mofetil (MMF) 1 to 2 gram tablet daily throughout this extension study (or up to 3 mg daily for Black participants). Prednisone 5mg daily (or equivalent) was also maintained through at least 12 months posttransplant (parent study).
543591|NCT00658333|B3|Baseline|Total|Total of all reporting groups
543592|NCT00658333|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543593|NCT00658333|B1|Baseline|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543594|NCT00658333|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543595|NCT00658333|P1|Participant Flow|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543596|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543597|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543598|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543599|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543600|NCT00658333|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543601|NCT00658333|E1|Reported Event|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
543602|NCT00658320|B3|Baseline|Total|Total of all reporting groups
543603|NCT00658320|B2|Baseline|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543604|NCT00658320|B1|Baseline|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543605|NCT00658320|P2|Participant Flow|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
543606|NCT00658320|P1|Participant Flow|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543671|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543829|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
543608|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543609|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
543610|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543611|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543612|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
543613|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543614|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
543615|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543616|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
543617|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543672|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543673|NCT00657709|O4|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543619|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543620|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543621|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543622|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543623|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543624|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543625|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
543626|NCT00658320|E2|Reported Event|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
543627|NCT00658320|E1|Reported Event|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
543628|NCT00658138|B1|Baseline|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
543629|NCT00658138|P1|Participant Flow|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
543630|NCT00658138|O2|Outcome|Scotchbond 1XT|3M ESPE Adper Scotchbond 1XT
543631|NCT00658138|O1|Outcome|Scotchbond SE|3M ESPE Adper Scotchbond SE
543632|NCT00658138|E1|Reported Event|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
543633|NCT00658112|B1|Baseline|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
543674|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543634|NCT00658112|P1|Participant Flow|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
543635|NCT00658112|O1|Outcome|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
543636|NCT00658112|E1|Reported Event|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
543637|NCT00657709|B6|Baseline|Total|Total of all reporting groups
543638|NCT00657709|B5|Baseline|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
543639|NCT00657709|B4|Baseline|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543640|NCT00657709|B3|Baseline|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543641|NCT00657709|B2|Baseline|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543642|NCT00657709|B1|Baseline|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543643|NCT00657709|P5|Participant Flow|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
543644|NCT00657709|P4|Participant Flow|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543645|NCT00657709|P3|Participant Flow|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543646|NCT00657709|P2|Participant Flow|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543647|NCT00657709|P1|Participant Flow|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543648|NCT00657709|O2|Outcome|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
543649|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543650|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543651|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543652|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543653|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ(Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543654|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543655|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543656|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot2, or Lot3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543657|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ(Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543658|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543659|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ(Lot1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543660|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543661|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543662|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543663|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543664|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543968|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543675|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543676|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543677|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543678|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543679|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543680|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543681|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543682|NCT00657709|E5|Reported Event|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
543683|NCT00657709|E4|Reported Event|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
543684|NCT00657709|E3|Reported Event|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543685|NCT00657709|E2|Reported Event|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543686|NCT00657709|E1|Reported Event|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
543687|NCT00657657|B1|Baseline|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543688|NCT00657657|P1|Participant Flow|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543689|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543690|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543691|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543692|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543693|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543694|NCT00657657|E1|Reported Event|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
543695|NCT00657618|B1|Baseline|Sodium Stibogluconate (SSG)|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
543696|NCT00657618|P1|Participant Flow|Sodium Stibogluconate (SSG)|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
543697|NCT00657618|O1|Outcome|Treatment Only|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
543698|NCT00657618|O1|Outcome|Treatment Only|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
543699|NCT00657618|E1|Reported Event|Treatment Only|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
543700|NCT00657553|B3|Baseline|Total|Total of all reporting groups
543701|NCT00657553|B2|Baseline|Observation Arm|Patients will be observed for progress over the course of three years.
543702|NCT00657553|B1|Baseline|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
543703|NCT00657553|P2|Participant Flow|Observation Arm|Patients will be observed for progress over the course of three years.
543704|NCT00657553|P1|Participant Flow|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
543705|NCT00657553|O2|Outcome|Observation Arm|Patients will be observed for progress over the course of three years.
543828|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
543706|NCT00657553|O1|Outcome|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
543707|NCT00657553|E2|Reported Event|Observation Arm|Patients will be observed for progress over the course of three years.
543708|NCT00657553|E1|Reported Event|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
543709|NCT00657540|B3|Baseline|Total|Total of all reporting groups
543710|NCT00657540|B2|Baseline|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543711|NCT00657540|B1|Baseline|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543712|NCT00657540|P2|Participant Flow|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543713|NCT00657540|P1|Participant Flow|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543714|NCT00657540|O2|Outcome|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543715|NCT00657540|O1|Outcome|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543716|NCT00657540|O2|Outcome|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543717|NCT00657540|O1|Outcome|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543718|NCT00657540|O2|Outcome|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543719|NCT00657540|O1|Outcome|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543720|NCT00657540|O2|Outcome|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543721|NCT00657540|O1|Outcome|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543722|NCT00657540|O2|Outcome|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543723|NCT00657540|O1|Outcome|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543724|NCT00657540|E2|Reported Event|Normal Saline|"Normal Saline~Saline: 50 mL of saline infused over 10 minutes"
543725|NCT00657540|E1|Reported Event|Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2|"Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2~Analatro: 30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses"
543726|NCT00657371|B1|Baseline|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
543727|NCT00657371|P1|Participant Flow|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
543728|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
543729|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
543730|NCT00657371|E1|Reported Event|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
543731|NCT00657358|B1|Baseline|Lidocaine|Healthy Volunteers receiving Lidocaine
543732|NCT00657358|P1|Participant Flow|Lidocaine|Healthy Volunteers receiving Lidocaine
543733|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
543734|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
543735|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
543736|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.infused within 20 minutes.
543737|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
543738|NCT00657358|E1|Reported Event|Lidocaine|Healthy Volunteers receiving Lidocaine
543739|NCT00657280|B1|Baseline|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
543740|NCT00657280|P1|Participant Flow|Sitagliptin|There is only one group. All the participants took Sitagliptin 100mg daily and acted as their own controls
543741|NCT00657280|O1|Outcome|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
543742|NCT00657280|E1|Reported Event|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
543743|NCT00657267|B1|Baseline|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
543744|NCT00657267|P1|Participant Flow|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
543745|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
544404|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
543746|NCT00657267|O2|Outcome|Complete Response|Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
543747|NCT00657267|O1|Outcome|Partial Response|Partial Responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
543748|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
543749|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
543750|NCT00657267|E1|Reported Event|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|All 58 participants who started treatment: Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets
543751|NCT00657150|B3|Baseline|Total|Total of all reporting groups
543752|NCT00657150|B2|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
543753|NCT00657150|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
543754|NCT00657150|P2|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
543755|NCT00657150|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
543756|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543757|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543758|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543759|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543760|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543761|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543762|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543763|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543764|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543765|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543766|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543767|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543768|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543769|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543770|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543771|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543772|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543773|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543774|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543775|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543776|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543777|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543778|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543779|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543780|NCT00657150|E2|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
543781|NCT00657150|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
543782|NCT00657046|B4|Baseline|Total|Total of all reporting groups
543783|NCT00657046|B3|Baseline|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543784|NCT00657046|B2|Baseline|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543785|NCT00657046|B1|Baseline|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543786|NCT00657046|P3|Participant Flow|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543787|NCT00657046|P2|Participant Flow|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543788|NCT00657046|P1|Participant Flow|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543789|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543790|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543791|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543792|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543793|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543794|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543795|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543796|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543797|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543798|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543799|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543800|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543801|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543802|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543803|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543804|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543805|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543806|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543807|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543808|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543809|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543810|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543811|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543812|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543813|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543814|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543815|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543816|NCT00657046|E3|Reported Event|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543817|NCT00657046|E2|Reported Event|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543818|NCT00657046|E1|Reported Event|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
543819|NCT00657020|B1|Baseline|All Randomized Participants|All randomized participants who receive study treatments.
543820|NCT00657020|P2|Participant Flow|Placebo Lozenge Then 4 mg Nicotine Lozenge|Participants received placebo lozenge in Period I and nicotine 4 mg lozenge in Period II.
543821|NCT00657020|P1|Participant Flow|4 mg Nicotine Lozenge Then Placebo Lozenge|Participants received nicotine lozenge containing 4 milligrams (mg) of nicotine in Period I and placebo lozenge in Period II.
543822|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
543823|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
543824|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
543825|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
543826|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
543827|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
543830|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
543831|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
543832|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
543833|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
543834|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
543835|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
543836|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
543837|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
543838|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
543839|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
543840|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
543841|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
543842|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
543843|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
543844|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
543845|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
543846|NCT00657020|E2|Reported Event|Placebo Lozenge|Participants in safety population received placebo lozenge.
543847|NCT00657020|E1|Reported Event|Nicotine Lozenge|Participants in safety population received 4 mg of nicotine lozenge.
543848|NCT00656968|B3|Baseline|Total|Total of all reporting groups
543849|NCT00656968|B2|Baseline|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
543850|NCT00656968|B1|Baseline|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
543851|NCT00656968|P2|Participant Flow|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
543852|NCT00656968|P1|Participant Flow|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
543853|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
543854|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
543855|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
543856|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
543857|NCT00656968|E2|Reported Event|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
543858|NCT00656968|E1|Reported Event|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
543859|NCT00656916|B3|Baseline|Total|Total of all reporting groups
543860|NCT00656916|B2|Baseline|Observation|Comparator group, no intervention.
543861|NCT00656916|B1|Baseline|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
543862|NCT00656916|P2|Participant Flow|Observation|Comparator group, no intervention.
543863|NCT00656916|P1|Participant Flow|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
543864|NCT00656916|O2|Outcome|Observation|Comparator group, no intervention.
543865|NCT00656916|O1|Outcome|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
543866|NCT00656916|E2|Reported Event|Observation|Comparator group, no intervention.
543867|NCT00656916|E1|Reported Event|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
543868|NCT00656851|B3|Baseline|Total|Total of all reporting groups
543869|NCT00656851|B2|Baseline|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543870|NCT00656851|B1|Baseline|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543871|NCT00656851|P2|Participant Flow|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543872|NCT00656851|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543873|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543874|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543875|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543876|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543877|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543878|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543879|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543880|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
544405|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
543881|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543882|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543883|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543884|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543885|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543886|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543887|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543888|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543889|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543890|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543891|NCT00656851|E2|Reported Event|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
543892|NCT00656851|E1|Reported Event|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
543893|NCT00656799|B1|Baseline|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543894|NCT00656799|P1|Participant Flow|Sugammadex|Intravenous (IV) single bolus dose of 4.0 mg/kg sugammadex
543895|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543896|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543897|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543898|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543899|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543900|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543901|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543902|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543903|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543904|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543905|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543906|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543907|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543908|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543909|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543910|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543911|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543912|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543913|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543914|NCT00656799|E1|Reported Event|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
543915|NCT00656669|B1|Baseline|Overall Study|These patients are for the patients who were into the trial.
543916|NCT00656669|P1|Participant Flow|Segment Information|This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.
543917|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who were in the paclitaxel plus sunitinib segment
543918|NCT00656669|O1|Outcome|AC Dosing|Patients who finished the AC dosing segment
543919|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who finished the paclitaxel plus sunitinib segment
543920|NCT00656669|O1|Outcome|Sunitinib Monotherapy|Patients who completed the Sunitinib monotherapy segment
543921|NCT00656669|E3|Reported Event|AC Dosing|4 cycles (8 weeks) of neoadjuvant treatment with AC.
543922|NCT00656669|E2|Reported Event|Paclitaxel/Sunitinib|4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
543923|NCT00656669|E1|Reported Event|Single Agent Sunitinib|Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.
543924|NCT00656656|B1|Baseline|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
543925|NCT00656656|P1|Participant Flow|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
543926|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
543969|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543970|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
544406|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
543927|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
543928|NCT00656656|E1|Reported Event|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
543929|NCT00656630|B4|Baseline|Total|Total of all reporting groups
543930|NCT00656630|B3|Baseline|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
543931|NCT00656630|B2|Baseline|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543932|NCT00656630|B1|Baseline|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543933|NCT00656630|P3|Participant Flow|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
543934|NCT00656630|P2|Participant Flow|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543935|NCT00656630|P1|Participant Flow|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543936|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
543937|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543938|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543939|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
543940|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543941|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543942|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
543943|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543944|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543945|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
543946|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543947|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543948|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
543949|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543950|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543951|NCT00656630|E3|Reported Event|Placebo|Placebo: Double-dummy placebo capsules, 1 week duration
543952|NCT00656630|E2|Reported Event|Naltrexone|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
543953|NCT00656630|E1|Reported Event|Acamprosate|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
543954|NCT00656617|B1|Baseline|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
543955|NCT00656617|P1|Participant Flow|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
543956|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
543957|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
543958|NCT00656617|E2|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 2)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
543959|NCT00656617|E1|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 1)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
543960|NCT00656513|B4|Baseline|Total|Total of all reporting groups
543961|NCT00656513|B3|Baseline|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543962|NCT00656513|B2|Baseline|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543963|NCT00656513|B1|Baseline|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543964|NCT00656513|P3|Participant Flow|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543965|NCT00656513|P2|Participant Flow|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543966|NCT00656513|P1|Participant Flow|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543967|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
544407|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
543971|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543972|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543973|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543974|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543975|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543976|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543977|NCT00656513|O1|Outcome|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543978|NCT00656513|O2|Outcome|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543979|NCT00656513|O1|Outcome|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543980|NCT00656513|O1|Outcome|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543981|NCT00656513|E3|Reported Event|ALTENS: Phase III|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543982|NCT00656513|E2|Reported Event|Pilocarpine: Phase III|5mg pilocarpine by mouth 3 times a day for 12 weeks
543983|NCT00656513|E1|Reported Event|ALTENS: Phase II|Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
543984|NCT00656487|B4|Baseline|Total|Total of all reporting groups
543985|NCT00656487|B3|Baseline|Control|Participants were non-cannabis using controls.
543986|NCT00656487|B2|Baseline|Placebo|Participants were cannabis dependent and received matched placebo.
543987|NCT00656487|B1|Baseline|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
543988|NCT00656487|P3|Participant Flow|Control|Participants were non-cannabis using controls.
543989|NCT00656487|P2|Participant Flow|Placebo|Participants were cannabis dependent and received matched placebo.
543990|NCT00656487|P1|Participant Flow|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
543991|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
543992|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
543993|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
543994|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
543995|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
543996|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
543997|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
543998|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
543999|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
544000|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
544001|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
544002|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
544003|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
544004|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
544005|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
544006|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
544007|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
544008|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
544009|NCT00656487|E3|Reported Event|Control|Participants were non-cannabis using controls.
544010|NCT00656487|E2|Reported Event|Placebo|Participants were cannabis dependent and received matched placebo.
544011|NCT00656487|E1|Reported Event|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
544012|NCT00656474|B1|Baseline|GLYC-101 and Placebo|Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
544013|NCT00656474|P1|Participant Flow|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
544014|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
544015|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
544016|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
544017|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
544018|NCT00656474|E1|Reported Event|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
544019|NCT00656448|B3|Baseline|Total|Total of all reporting groups
544020|NCT00656448|B2|Baseline|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
544395|NCT00655356|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
544021|NCT00656448|B1|Baseline|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
544022|NCT00656448|P2|Participant Flow|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
544023|NCT00656448|P1|Participant Flow|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
544024|NCT00656448|O2|Outcome|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
544025|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
544026|NCT00656448|O2|Outcome|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
544027|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
544028|NCT00656448|E2|Reported Event|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
544029|NCT00656448|E1|Reported Event|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
544030|NCT00656370|B1|Baseline|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
544031|NCT00656370|P1|Participant Flow|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
544032|NCT00656370|O1|Outcome|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
544033|NCT00656370|O2|Outcome|LR Infusion Group|Maximal post baseline increase in VAS score for LR infusions.
544034|NCT00656370|O1|Outcome|NS Infusion Group|Maximal post baseline increase VAS score for NS infusion.
544035|NCT00656370|E1|Reported Event|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
544036|NCT00656292|B3|Baseline|Total|Total of all reporting groups
544037|NCT00656292|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544038|NCT00656292|B1|Baseline|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544039|NCT00656292|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544040|NCT00656292|P1|Participant Flow|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544041|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544121|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
544042|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544043|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544044|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544045|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544046|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544047|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544048|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544049|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544050|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544051|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544052|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544081|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
544053|NCT00656292|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544054|NCT00656292|E1|Reported Event|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
544055|NCT00656201|B3|Baseline|Total|Total of all reporting groups
544056|NCT00656201|B2|Baseline|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
544057|NCT00656201|B1|Baseline|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
544058|NCT00656201|P2|Participant Flow|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
544059|NCT00656201|P1|Participant Flow|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
544060|NCT00656201|O2|Outcome|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
544061|NCT00656201|O1|Outcome|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
544062|NCT00656201|E2|Reported Event|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
544063|NCT00656201|E1|Reported Event|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
544064|NCT00656175|B3|Baseline|Total|Total of all reporting groups
544065|NCT00656175|B2|Baseline|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
544066|NCT00656175|B1|Baseline|Immediate|Immediate switch of PI or NNRTI to Raltegravir
544067|NCT00656175|P2|Participant Flow|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
544068|NCT00656175|P1|Participant Flow|Immediate|Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
544069|NCT00656175|O2|Outcome|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
544070|NCT00656175|O1|Outcome|Immediate|Immediate switch of PI or NNRTI to Raltegravir
544071|NCT00656175|E2|Reported Event|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
544072|NCT00656175|E1|Reported Event|Immediate|Immediate switch of PI or NNRTI to Raltegravir
544073|NCT00656136|B3|Baseline|Total|Total of all reporting groups
544074|NCT00656136|B2|Baseline|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
544075|NCT00656136|B1|Baseline|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
544076|NCT00656136|P2|Participant Flow|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus Best Supportive Care (BSC) or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
544077|NCT00656136|P1|Participant Flow|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
544078|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
544079|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
544080|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
544396|NCT00655083|B3|Baseline|Total|Total of all reporting groups
544397|NCT00655083|B2|Baseline|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
544082|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
544083|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
544084|NCT00656136|E2|Reported Event|Afatinib 50 mg/Day|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
544085|NCT00656136|E1|Reported Event|Placebo|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
544086|NCT00656084|B1|Baseline|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
544087|NCT00656084|P1|Participant Flow|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
544088|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
544089|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
544090|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
544091|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
544092|NCT00656084|E1|Reported Event|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
544093|NCT00656058|B1|Baseline|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544094|NCT00656058|P1|Participant Flow|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544095|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544096|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544097|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544098|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544099|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544100|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544101|NCT00656058|E1|Reported Event|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
544102|NCT00656019|B5|Baseline|Total|Total of all reporting groups
544103|NCT00656019|B4|Baseline|6000 UI Vitamin D|Patients with breast cancer detected by biopsy
544104|NCT00656019|B3|Baseline|4000 UI Vitamin D|Patients with breast cancer detected by biopsy
544105|NCT00656019|B2|Baseline|2000 UI Vitamin D|Patients with breast cancer detected by biopsy
544106|NCT00656019|B1|Baseline|No Intervention (No Vitamin D)|Patients with breast cancer detected by biopsy
544107|NCT00656019|P4|Participant Flow|Very-low Vitamin D Levels|6000 IU dose of Vitamin D per day administered orally
544108|NCT00656019|P3|Participant Flow|Low Vitamin D Levels|4000 IU dose of Vitamin D per day administered orally
544109|NCT00656019|P2|Participant Flow|Low-normal Vitamin D Levels|2000 IU dose of Vitamin D per day administered orally
544110|NCT00656019|P1|Participant Flow|Normal Vitamin D Levels|No additional Vitamin D administered
544111|NCT00656019|O4|Outcome|Very-low Vitamin D Levels|6000 IU dose of Vitamin D per day administered orally
544112|NCT00656019|O3|Outcome|Low Vitamin D Levels|4000 IU dose of Vitamin D per day administered orally
544113|NCT00656019|O2|Outcome|Low-normal Vitamin D Levels|2000 IU dose of Vitamin D per day administered orally
544114|NCT00656019|O1|Outcome|Normal Vitamin D Levels|No additional Vitamin D administered
544115|NCT00656019|E4|Reported Event|Vitamin D Very Low|"6000 IU dose of vitamin D per day (these patients have very low vitamin D levels).~Vitamin D: 6000 IU per day orally"
544116|NCT00656019|E3|Reported Event|Vitamin D Low|"4000 IU dose of vitamin D per day (these patients have low vitamin D levels).~Vitamin D: 4000 IU per day orally"
544117|NCT00656019|E2|Reported Event|Vitamin D Low-normal|"2000 IU dose of vitamin D per day (these patients have slightly low vitamin D levels).~Vitamin D: 2000 IU per day orally"
544118|NCT00656019|E1|Reported Event|Vitamin D Normal|No Additional Vitamin D will be given (these patients have normal Vitamin D levels).
544119|NCT00655889|B1|Baseline|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
544120|NCT00655889|P1|Participant Flow|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
544122|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
544123|NCT00655889|E1|Reported Event|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
544124|NCT00655876|B3|Baseline|Total|Total of all reporting groups
544125|NCT00655876|B2|Baseline|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544126|NCT00655876|B1|Baseline|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544127|NCT00655876|P2|Participant Flow|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544128|NCT00655876|P1|Participant Flow|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544129|NCT00655876|O2|Outcome|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544130|NCT00655876|O1|Outcome|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544131|NCT00655876|O2|Outcome|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544132|NCT00655876|O1|Outcome|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544133|NCT00655876|O2|Outcome|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544134|NCT00655876|O1|Outcome|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544135|NCT00655876|O2|Outcome|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544136|NCT00655876|O1|Outcome|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544137|NCT00655876|O2|Outcome|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544138|NCT00655876|O1|Outcome|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544139|NCT00655876|O2|Outcome|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544140|NCT00655876|O1|Outcome|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
544141|NCT00655876|E2|Reported Event|Chemoradiation|External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
544142|NCT00655876|E1|Reported Event|Chemoradiation + Cetuximab|External beam radiation therapy (RT) with concurrent weekly paclitaxel, and cisplatin, a
544143|NCT00655863|B4|Baseline|Total|Total of all reporting groups
544144|NCT00655863|B3|Baseline|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544145|NCT00655863|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544146|NCT00655863|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544147|NCT00655863|P3|Participant Flow|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544148|NCT00655863|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544149|NCT00655863|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544150|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544151|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544152|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544153|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544154|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544155|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544156|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544157|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544158|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544159|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544160|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544161|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544162|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544163|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544398|NCT00655083|B1|Baseline|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
544164|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544165|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544166|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544167|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544168|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544169|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544170|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544171|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544172|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544173|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544174|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544175|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544176|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544177|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544178|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544179|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544180|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544181|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544182|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544183|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544184|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544185|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544186|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544187|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544188|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544189|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544190|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544191|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544192|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544193|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544194|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544195|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544196|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544197|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544198|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544199|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544200|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544201|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544202|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544203|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544204|NCT00655863|E3|Reported Event|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
544205|NCT00655863|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544206|NCT00655863|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
544207|NCT00655850|B1|Baseline|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
544208|NCT00655850|P1|Participant Flow|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
544209|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
544210|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
544211|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
544212|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
544213|NCT00655850|E1|Reported Event|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
544306|NCT00655642|O3|Outcome|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
544307|NCT00655642|O2|Outcome|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
544408|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
544214|NCT00655824|B1|Baseline|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544215|NCT00655824|P1|Participant Flow|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544216|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544217|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544218|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544219|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544220|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544221|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544308|NCT00655642|O1|Outcome|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
544309|NCT00655642|E4|Reported Event|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
544222|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544223|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544224|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544225|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544226|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544227|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544228|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544229|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544310|NCT00655642|E3|Reported Event|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
544311|NCT00655642|E2|Reported Event|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
544230|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544231|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544232|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544233|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544234|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544235|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544236|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544237|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544312|NCT00655642|E1|Reported Event|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
544313|NCT00655629|B3|Baseline|Total|Total of all reporting groups
544238|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544239|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544240|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544241|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544242|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544243|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544244|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544245|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544314|NCT00655629|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544399|NCT00655083|P2|Participant Flow|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
544246|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544247|NCT00655824|E1|Reported Event|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
544248|NCT00655811|B1|Baseline|Capsaicin and Placebo|"0.1% Topical Capsaicin cream was appled to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544249|NCT00655811|P1|Participant Flow|Capsaicin and Placebo|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544250|NCT00655811|O2|Outcome|Placebo|"A placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544251|NCT00655811|O1|Outcome|Capsaicin|"0.1% Topical Capsaicin cream was applied to one forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544252|NCT00655811|O4|Outcome|Hispanics|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544253|NCT00655811|O3|Outcome|East Asians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544254|NCT00655811|O2|Outcome|Caucasians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544255|NCT00655811|O1|Outcome|African Americans|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544256|NCT00655811|O4|Outcome|Hispanics|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544257|NCT00655811|O3|Outcome|East Asians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544258|NCT00655811|O2|Outcome|Caucasians|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544393|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
544259|NCT00655811|O1|Outcome|African Americans|"0.1% Topical Capsaicin cream was applied to one forearm and a placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544260|NCT00655811|E2|Reported Event|Placebo|"A placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) was applied to the other forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544261|NCT00655811|E1|Reported Event|Capsaicin|"0.1% Topical Capsaicin cream was applied to one forearm.~A volume of 0·3 mL cream was applied in a thin layer of virtually equal thickness, on a 4 × 4 cm area, around midline. The creams were applied at a 40-min interval in a random order to minimize an order effect. The creams were randomized for right and left arm application."
544262|NCT00655746|B1|Baseline|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
544263|NCT00655746|P1|Participant Flow|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
544264|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
544265|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
544266|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
544267|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
544268|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
544269|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
544270|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
544271|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
544272|NCT00655746|O4|Outcome|All Participants|
544273|NCT00655746|O3|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
544274|NCT00655746|O2|Outcome|Omeprazole (Days 2-5)|40-mg oral omeprazole
544275|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
544276|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
544277|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
544278|NCT00655746|E1|Reported Event|BMS-354825 + Omeprazole|
544279|NCT00655733|B3|Baseline|Total|Total of all reporting groups
544280|NCT00655733|B2|Baseline|Placebo|Placebo
544281|NCT00655733|B1|Baseline|HMPL004|HMPL004 1200mg/d
544282|NCT00655733|P2|Participant Flow|Placebo|Placebo
544283|NCT00655733|P1|Participant Flow|HMPL004|HMPL004 1200mg/d
544284|NCT00655733|O2|Outcome|Placebo|Placebo
544285|NCT00655733|O1|Outcome|HMPL004|HMPL004 1200mg/d
544286|NCT00655733|E2|Reported Event|Placebo|Placebo
544287|NCT00655733|E1|Reported Event|HMPL004|HMPL004 1200mg/d
544288|NCT00655668|B1|Baseline|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544289|NCT00655668|P1|Participant Flow|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544290|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544291|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544292|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544293|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544294|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544295|NCT00655668|E1|Reported Event|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
544296|NCT00655642|B5|Baseline|Total|Total of all reporting groups
544297|NCT00655642|B4|Baseline|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
544298|NCT00655642|B3|Baseline|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
544299|NCT00655642|B2|Baseline|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
544300|NCT00655642|B1|Baseline|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
544301|NCT00655642|P4|Participant Flow|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
544302|NCT00655642|P3|Participant Flow|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
544303|NCT00655642|P2|Participant Flow|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
544304|NCT00655642|P1|Participant Flow|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
544305|NCT00655642|O4|Outcome|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
544315|NCT00655629|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544316|NCT00655629|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544317|NCT00655629|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544318|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544319|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544320|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544321|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544322|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544323|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544324|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544325|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544326|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544327|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544328|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544329|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544330|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544331|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544332|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544333|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544334|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544335|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544336|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544337|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544338|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544339|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544340|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544341|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544342|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544343|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544344|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544345|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544346|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544347|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544348|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544349|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544394|NCT00655356|E2|Reported Event|Placebo|Patients treated with placebo solution.
544350|NCT00655629|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544351|NCT00655629|E1|Reported Event|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
544352|NCT00655564|B1|Baseline|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
544353|NCT00655564|P1|Participant Flow|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
544354|NCT00655564|O1|Outcome|Alefacept|All subjects received alefacept injections per FDA dosing guidelines for the duration of the 52 weeks study
544355|NCT00655564|O1|Outcome|Alefacept|Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
544356|NCT00655564|E1|Reported Event|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
544357|NCT00655551|B4|Baseline|Total|Total of all reporting groups
544358|NCT00655551|B3|Baseline|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
544359|NCT00655551|B2|Baseline|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
544360|NCT00655551|B1|Baseline|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
544361|NCT00655551|P3|Participant Flow|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
544362|NCT00655551|P2|Participant Flow|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
544363|NCT00655551|P1|Participant Flow|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
544364|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
544365|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
544366|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
544367|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
544368|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
544369|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
544370|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
544371|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
544372|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
544373|NCT00655551|E3|Reported Event|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
544374|NCT00655551|E2|Reported Event|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
544375|NCT00655551|E1|Reported Event|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
544376|NCT00655486|B1|Baseline|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
544377|NCT00655486|P1|Participant Flow|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
544378|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
544379|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
544380|NCT00655486|E1|Reported Event|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
544381|NCT00655356|B3|Baseline|Total|Total of all reporting groups
544382|NCT00655356|B2|Baseline|Placebo|Patients treated with placebo solution
544383|NCT00655356|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
544384|NCT00655356|P2|Participant Flow|Placebo|Patients treated with placebo solution
544385|NCT00655356|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
544386|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
544387|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
544388|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
544389|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
544390|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
544391|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
544392|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
544409|NCT00655083|E2|Reported Event|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
544410|NCT00655083|E1|Reported Event|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
544411|NCT00654992|B3|Baseline|Total|Total of all reporting groups
544412|NCT00654992|B2|Baseline|Placebo Group|received normal saline intraveously following induction of anesthesia
544413|NCT00654992|B1|Baseline|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
544414|NCT00654992|P2|Participant Flow|Placebo Group|received normal saline intraveously following induction of anesthesia
544415|NCT00654992|P1|Participant Flow|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
544416|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
544417|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
544418|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
544419|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
544420|NCT00654953|B4|Baseline|Total|Total of all reporting groups
544421|NCT00654953|B3|Baseline|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
544422|NCT00654953|B2|Baseline|Active Group: Sertraline Alone|sertraline (200 mg/day)
544423|NCT00654953|B1|Baseline|Placebo Group|Placebo capsules
544424|NCT00654953|P3|Participant Flow|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
544425|NCT00654953|P2|Participant Flow|Active Group: Sertraline Alone|sertraline (200 mg/day)
544426|NCT00654953|P1|Participant Flow|Placebo Group|Placebo capsules
544427|NCT00654953|O3|Outcome|Sertraline Plus Gabapentin|
544428|NCT00654953|O2|Outcome|Sertraline|
544429|NCT00654953|O1|Outcome|Placebo|
544430|NCT00654953|E3|Reported Event|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
544431|NCT00654953|E2|Reported Event|Active Group: Sertraline Alone|sertraline (200 mg/day)
544432|NCT00654953|E1|Reported Event|Placebo Group|Placebo capsules
544433|NCT00654940|B3|Baseline|Total|Total of all reporting groups
544434|NCT00654940|B2|Baseline|Placebo Then Pregabalin|Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
544435|NCT00654940|B1|Baseline|Pregabalin Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
544436|NCT00654940|P2|Participant Flow|Placebo First Then Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14.
544437|NCT00654940|P1|Participant Flow|Pregabalin First Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
544438|NCT00654940|O2|Outcome|Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
544439|NCT00654940|O1|Outcome|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
544440|NCT00654940|O2|Outcome|Placebo/Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
544441|NCT00654940|O1|Outcome|Pregabalin/Placebo|Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
544442|NCT00654940|O4|Outcome|Period 2: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
544443|NCT00654940|O3|Outcome|Period 2: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
544444|NCT00654940|O2|Outcome|Period 1: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
544445|NCT00654940|O1|Outcome|Period 1: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
544446|NCT00654940|E2|Reported Event|Placebo|Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
544447|NCT00654940|E1|Reported Event|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
544448|NCT00654927|B1|Baseline|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544449|NCT00654927|P1|Participant Flow|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544450|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544451|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544452|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544453|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544895|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544454|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544455|NCT00654927|E1|Reported Event|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
544456|NCT00654901|B5|Baseline|Total|Total of all reporting groups
544457|NCT00654901|B4|Baseline|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
544458|NCT00654901|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544459|NCT00654901|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544460|NCT00654901|B1|Baseline|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544461|NCT00654901|P4|Participant Flow|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
544462|NCT00654901|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544463|NCT00654901|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544464|NCT00654901|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544465|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
544466|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544467|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544468|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544469|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
544470|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544471|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544491|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544472|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544473|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
544474|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544475|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544476|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544477|NCT00654901|E4|Reported Event|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
544478|NCT00654901|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544479|NCT00654901|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544480|NCT00654901|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
544481|NCT00654875|B3|Baseline|Total|Total of all reporting groups
544482|NCT00654875|B2|Baseline|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544483|NCT00654875|B1|Baseline|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544484|NCT00654875|P2|Participant Flow|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544485|NCT00654875|P1|Participant Flow|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544486|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544487|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544488|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544489|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544490|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544896|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544492|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544493|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544494|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544495|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544496|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544497|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544498|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544499|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544500|NCT00654875|E2|Reported Event|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
544501|NCT00654875|E1|Reported Event|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
544502|NCT00654836|B1|Baseline|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
544503|NCT00654836|P1|Participant Flow|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
544504|NCT00654836|O1|Outcome|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
544505|NCT00654836|O1|Outcome|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
544546|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544506|NCT00654836|O1|Outcome|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
544507|NCT00654836|E1|Reported Event|Carboplatin, ABI-007 and Bevacizumab|Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.
544508|NCT00654784|B3|Baseline|Total|Total of all reporting groups
544509|NCT00654784|B2|Baseline|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
544510|NCT00654784|B1|Baseline|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
544511|NCT00654784|P2|Participant Flow|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
544512|NCT00654784|P1|Participant Flow|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
544513|NCT00654784|O2|Outcome|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
544514|NCT00654784|O1|Outcome|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
544515|NCT00654784|E2|Reported Event|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
544516|NCT00654784|E1|Reported Event|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
544517|NCT00654745|B1|Baseline|Aml + Olm + Hctz|amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.
544518|NCT00654745|P1|Participant Flow|Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide|Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544519|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544520|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544521|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544522|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544523|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544524|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544525|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544526|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544527|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544528|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544529|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544530|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544531|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544532|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544533|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544534|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544535|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544536|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544537|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544538|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544539|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544540|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544541|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544542|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544543|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544544|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544545|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544646|NCT00654498|E1|Reported Event|Pramipexole|
544547|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544548|NCT00654745|E7|Reported Event|Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
544549|NCT00654745|E6|Reported Event|Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
544550|NCT00654745|E5|Reported Event|Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
544551|NCT00654745|E4|Reported Event|Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
544552|NCT00654745|E3|Reported Event|Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
544553|NCT00654745|E2|Reported Event|Start - Amlodipine 5 mg|All participants started trial on Amlodipine 5 mg.
544554|NCT00654745|E1|Reported Event|ALL - Aml + Olm + Hctz|Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
544555|NCT00654654|B1|Baseline|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
544556|NCT00654654|P1|Participant Flow|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
544557|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
544558|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
544559|NCT00654654|E1|Reported Event|Active|Patients treated with autologous human fibroblasts
544560|NCT00654641|B3|Baseline|Total|Total of all reporting groups
544561|NCT00654641|B2|Baseline|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
544562|NCT00654641|B1|Baseline|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
544563|NCT00654641|P2|Participant Flow|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
544564|NCT00654641|P1|Participant Flow|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
544565|NCT00654641|O2|Outcome|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
544566|NCT00654641|O1|Outcome|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
544567|NCT00654641|E2|Reported Event|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
544568|NCT00654641|E1|Reported Event|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
544569|NCT00654628|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544570|NCT00654628|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544571|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544572|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544573|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544574|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544575|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544576|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544577|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544578|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544579|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544580|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544581|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544582|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544583|NCT00654628|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
544584|NCT00654615|B3|Baseline|Total|Total of all reporting groups
544585|NCT00654615|B2|Baseline|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
544647|NCT00654420|B5|Baseline|Total|Total of all reporting groups
544648|NCT00654420|B4|Baseline|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544774|NCT00654329|P3|Participant Flow|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
544586|NCT00654615|B1|Baseline|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
544587|NCT00654615|P2|Participant Flow|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
544588|NCT00654615|P1|Participant Flow|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
544589|NCT00654615|O2|Outcome|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
544590|NCT00654615|O1|Outcome|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
544591|NCT00654615|O2|Outcome|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
544592|NCT00654615|O1|Outcome|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
544649|NCT00654420|B3|Baseline|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544775|NCT00654329|P2|Participant Flow|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
544593|NCT00654615|E2|Reported Event|Volar Plate Fixation - Group 2|"Volar Plate Fixation - Group 2~Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.~Volar Plate Fixation: After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied."
544594|NCT00654615|E1|Reported Event|Intramedullary Radius Fixation (Micronail) - Group 1|"Intramedullary Radius Fixation (Micronail) - Group 1~A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.~Intramedullary Radius Fixation (Micronail): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing."
544595|NCT00654511|B5|Baseline|Total|Total of all reporting groups
544596|NCT00654511|B4|Baseline|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
544597|NCT00654511|B3|Baseline|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
544598|NCT00654511|B2|Baseline|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
544599|NCT00654511|B1|Baseline|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
544600|NCT00654511|P4|Participant Flow|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
544601|NCT00654511|P3|Participant Flow|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
544602|NCT00654511|P2|Participant Flow|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
544603|NCT00654511|P1|Participant Flow|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
544604|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
544605|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
544606|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
544607|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
544608|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram IV|
544609|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram IV|
544610|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram IV|
544611|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram IV|
544612|NCT00654511|E4|Reported Event|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
544613|NCT00654511|E3|Reported Event|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
544614|NCT00654511|E2|Reported Event|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
544615|NCT00654511|E1|Reported Event|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
544616|NCT00654498|B3|Baseline|Total|Total of all reporting groups
544617|NCT00654498|B2|Baseline|Placebo|
544618|NCT00654498|B1|Baseline|Pramipexole|
544619|NCT00654498|P2|Participant Flow|Placebo|1 tablet (Pramipexole 0.125 mg matching placebo tablet), or 1 or 2 or 3 tablets (Pramipexole 0.25 mg matching placebo tablet), once daily
544620|NCT00654498|P1|Participant Flow|Pramipexole|4 weeks of individual dose titration starting with 0.125 mg pramipexole, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
544621|NCT00654498|O2|Outcome|Placebo|
544622|NCT00654498|O1|Outcome|Pramipexole|
544623|NCT00654498|O2|Outcome|Placebo|
544624|NCT00654498|O1|Outcome|Pramipexole|
544625|NCT00654498|O2|Outcome|Placebo|
544626|NCT00654498|O1|Outcome|Pramipexole|
544627|NCT00654498|O2|Outcome|Placebo|
544628|NCT00654498|O1|Outcome|Pramipexole|
544629|NCT00654498|O2|Outcome|Placebo|
544630|NCT00654498|O1|Outcome|Pramipexole|
544631|NCT00654498|O2|Outcome|Placebo|
544632|NCT00654498|O1|Outcome|Pramipexole|
544633|NCT00654498|O2|Outcome|Placebo|
544634|NCT00654498|O1|Outcome|Pramipexole|
544635|NCT00654498|O2|Outcome|Placebo|
544636|NCT00654498|O1|Outcome|Pramipexole|
544637|NCT00654498|O2|Outcome|Placebo|
544638|NCT00654498|O1|Outcome|Pramipexole|
544639|NCT00654498|O2|Outcome|Placebo|
544640|NCT00654498|O1|Outcome|Pramipexole|
544641|NCT00654498|O2|Outcome|Placebo|
544642|NCT00654498|O1|Outcome|Pramipexole|
544643|NCT00654498|O2|Outcome|Placebo|
544644|NCT00654498|O1|Outcome|Pramipexole|
544645|NCT00654498|E2|Reported Event|Placebo|
544650|NCT00654420|B2|Baseline|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544651|NCT00654420|B1|Baseline|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544652|NCT00654420|P4|Participant Flow|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544653|NCT00654420|P3|Participant Flow|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544654|NCT00654420|P2|Participant Flow|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544655|NCT00654420|P1|Participant Flow|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab intravenously (IV) at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544656|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544657|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544658|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544659|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544660|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544661|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544662|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544663|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544664|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544665|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544666|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544667|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544668|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544669|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544670|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544671|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544672|NCT00654420|E4|Reported Event|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544673|NCT00654420|E3|Reported Event|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
544674|NCT00654420|E2|Reported Event|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544675|NCT00654420|E1|Reported Event|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
544676|NCT00654381|B5|Baseline|Total|Total of all reporting groups
544677|NCT00654381|B4|Baseline|Voglibose|The patients with voglibose at the start of randomised study medication
544678|NCT00654381|B3|Baseline|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544679|NCT00654381|B2|Baseline|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544680|NCT00654381|B1|Baseline|Placebo|The patients with placebo at the start of randomised study medication
544681|NCT00654381|P6|Participant Flow|Voglibose - Voglibose - Linagliptin 10mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
544682|NCT00654381|P5|Participant Flow|Voglibose - Voglibose - Linagliptin 5mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
544683|NCT00654381|P4|Participant Flow|Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg|10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
544684|NCT00654381|P3|Participant Flow|Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg|5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
544685|NCT00654381|P2|Participant Flow|Placebo - Linagliptin 5mg - Linagliptin 10mg|Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
544686|NCT00654381|P1|Participant Flow|Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg|Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
544687|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544688|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544689|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544690|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544691|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
544692|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544693|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544694|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544695|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544696|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
544697|NCT00654381|O2|Outcome|Linagliptin 10mg|The patients with linagliptin 10 mg at the start of randomised study medication
544698|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544699|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
544700|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544701|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544702|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544703|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544704|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
544705|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
544706|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544707|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544708|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
544709|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
544710|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
544711|NCT00654381|E8|Reported Event|Linagliptin 10mg (Extension Stage After Voglibose)|
544712|NCT00654381|E7|Reported Event|Linagliptin 5mg (Extension Stage After Voglibose)|
544713|NCT00654381|E6|Reported Event|Voglibose (1st-2nd Stage)|
544714|NCT00654381|E5|Reported Event|Linagliptin 10mg (1st-2nd-Extension Stage)|
544715|NCT00654381|E4|Reported Event|Linagliptin 5mg (1st-2nd-Extension Stage)|
544716|NCT00654381|E3|Reported Event|Linagliptin 10mg (2nd-Extension Stage After Placebo)|
544717|NCT00654381|E2|Reported Event|Linagliptin 5mg (2nd-Extension Stage After Placebo)|
544718|NCT00654381|E1|Reported Event|Placebo (1st Stage)|
544719|NCT00654368|B4|Baseline|Total|Total of all reporting groups
544772|NCT00654329|B1|Baseline|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
544773|NCT00654329|P4|Participant Flow|Normal Saline Placebo|Normal saline placebo intranasal
544720|NCT00654368|B3|Baseline|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544721|NCT00654368|B2|Baseline|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544722|NCT00654368|B1|Baseline|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
544723|NCT00654368|P3|Participant Flow|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544724|NCT00654368|P2|Participant Flow|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544725|NCT00654368|P1|Participant Flow|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
544726|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544727|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544728|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544729|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544730|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544731|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544732|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544733|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544734|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544735|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544736|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544737|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544738|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544739|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544886|NCT00653224|B1|Baseline|Placebo|Matching oral placebo tablet daily for 14 days
544740|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544741|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544742|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544743|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544744|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544745|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544746|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544747|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544748|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544749|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544750|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544751|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544752|NCT00654368|E3|Reported Event|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
544753|NCT00654368|E2|Reported Event|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
544754|NCT00654368|E1|Reported Event|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
544755|NCT00654355|B3|Baseline|Total|Total of all reporting groups
544756|NCT00654355|B2|Baseline|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
544757|NCT00654355|B1|Baseline|Control Group|Group only had visits at Baseline and Week 4.
544758|NCT00654355|P2|Participant Flow|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
544759|NCT00654355|P1|Participant Flow|Control Group|Group only had visits at Baseline and Week 4.
544760|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
544761|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
544762|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
544763|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
544764|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
544765|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
544766|NCT00654355|E2|Reported Event|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
544767|NCT00654355|E1|Reported Event|Control Group|Group only had visits at Baseline and Week 4.
544768|NCT00654329|B5|Baseline|Total|Total of all reporting groups
544769|NCT00654329|B4|Baseline|Normal Saline Placebo|Normal saline placebo intranasal
544770|NCT00654329|B3|Baseline|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
544771|NCT00654329|B2|Baseline|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
544776|NCT00654329|P1|Participant Flow|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
544777|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
544778|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
544779|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
544780|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
544781|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
544782|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
544783|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
544784|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
544785|NCT00654329|E4|Reported Event|Normal Saline Placebo|Normal saline placebo intranasal
544786|NCT00654329|E3|Reported Event|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
544787|NCT00654329|E2|Reported Event|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
544788|NCT00654329|E1|Reported Event|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
544789|NCT00654186|B1|Baseline|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
544790|NCT00654186|P1|Participant Flow|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
544791|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
544792|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
544793|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
544794|NCT00654186|E1|Reported Event|Revlimid Orally for 21 Days|Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
544795|NCT00654147|B3|Baseline|Total|Total of all reporting groups
544796|NCT00654147|B2|Baseline|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours for 48 weeks & emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544797|NCT00654147|B1|Baseline|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet every 12 hours for 48 & Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544798|NCT00654147|P2|Participant Flow|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544799|NCT00654147|P1|Participant Flow|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544800|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544801|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544802|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544803|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544804|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544805|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544806|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544807|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544808|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544809|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544810|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544811|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544887|NCT00653224|P2|Participant Flow|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544812|NCT00654147|E2|Reported Event|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
544813|NCT00654147|E1|Reported Event|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
544814|NCT00654095|B1|Baseline|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
544815|NCT00654095|P1|Participant Flow|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
544816|NCT00654095|O1|Outcome|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
544817|NCT00654095|E1|Reported Event|Ezetimibe+Atorvastatin|
544818|NCT00654030|B1|Baseline|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
544819|NCT00654030|P1|Participant Flow|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
544820|NCT00654030|O1|Outcome|1650-G ARM|2 immunizations of 1650-G given 4 weeks apart
544821|NCT00654030|E1|Reported Event|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
544822|NCT00654004|B3|Baseline|Total|Total of all reporting groups
544823|NCT00654004|B2|Baseline|Controls|Subjects do not have a fatty acid oxidation disorder.
544824|NCT00654004|B1|Baseline|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544825|NCT00654004|P2|Participant Flow|Controls|Subjects do not have a fatty acid oxidation disorder.
544826|NCT00654004|P1|Participant Flow|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544827|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
544828|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544829|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
544830|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544831|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
544832|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544833|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
544834|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544835|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
544836|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544837|NCT00654004|E2|Reported Event|Controls|Subjects do not have a fatty acid oxidation disorder.
544838|NCT00654004|E1|Reported Event|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
544839|NCT00653939|B3|Baseline|Total|Total of all reporting groups
544840|NCT00653939|B2|Baseline|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544841|NCT00653939|B1|Baseline|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544842|NCT00653939|P2|Participant Flow|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544843|NCT00653939|P1|Participant Flow|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544888|NCT00653224|P1|Participant Flow|Placebo|Matching oral placebo tablet daily for 14 days
544889|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544890|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544891|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544892|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544844|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544845|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544846|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544847|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544848|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544849|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544850|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544851|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544852|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544853|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544893|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544894|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544854|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544855|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544856|NCT00653939|E2|Reported Event|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544857|NCT00653939|E1|Reported Event|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
544858|NCT00653861|B1|Baseline|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
544859|NCT00653861|P1|Participant Flow|Total Study Participants|Subjects who received Juvederm with Lidocaine in one nasolabial fold and Juvederm without Lidocaine in the other nasolabial fold
544860|NCT00653861|O2|Outcome|Juvéderm NLFs|Nasolabial folds on the corresponding side of the face injected with Juvederm
544861|NCT00653861|O1|Outcome|Juvéderm Lidocaine NLFs|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
544862|NCT00653861|O1|Outcome|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
544863|NCT00653861|O2|Outcome|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
544864|NCT00653861|O1|Outcome|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
544865|NCT00653861|E2|Reported Event|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
544866|NCT00653861|E1|Reported Event|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
544867|NCT00653523|B1|Baseline|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
544868|NCT00653523|P1|Participant Flow|Ezetimibe + Simvastatin|"Ezetimibe 10 mg + Simvastatin 20 mg~level below what was specified in inclusion criterion~level >2x upper limit of normal at start of treatment~level >=3x upper limit of normal after start of treatment~did not resolve or improve after dose reduction of simvastatin"
544869|NCT00653523|O1|Outcome|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
544870|NCT00653523|E1|Reported Event|Ezetimibe+Simvastatin|
544871|NCT00653328|B1|Baseline|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
544872|NCT00653328|P1|Participant Flow|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
544873|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
544874|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
544875|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
544876|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
544877|NCT00653328|E1|Reported Event|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
544878|NCT00653263|B1|Baseline|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
544879|NCT00653263|P1|Participant Flow|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
544880|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
544881|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
544882|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
544883|NCT00653263|E1|Reported Event|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
544884|NCT00653224|B3|Baseline|Total|Total of all reporting groups
544885|NCT00653224|B2|Baseline|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544897|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544898|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544899|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544900|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544901|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544902|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544903|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544904|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544905|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544906|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544907|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544908|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544909|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544910|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544911|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544912|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544913|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544914|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544915|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544916|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544917|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544918|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544919|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544920|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544921|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544922|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544923|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544924|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544925|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544926|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544927|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544928|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544929|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544930|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544931|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544932|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544933|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544934|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544935|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544936|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544937|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544938|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544939|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544940|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544941|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544942|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544943|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544944|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544945|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544946|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544947|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544948|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544949|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544950|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544951|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544952|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544953|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544954|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544955|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544956|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544957|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544958|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544959|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544960|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544961|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544962|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544963|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544964|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544965|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544966|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544967|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544968|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544969|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544970|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544971|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544972|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544973|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544974|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544975|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544976|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544977|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544978|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544979|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544980|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544981|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544982|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544983|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544984|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544985|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544986|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544987|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544988|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544989|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544990|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544991|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544992|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544993|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544994|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544995|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544996|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544997|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
544998|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
544999|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545000|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545001|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545002|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545003|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545004|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545005|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545006|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545007|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545008|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545009|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545010|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545011|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545012|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545013|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545014|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545015|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545016|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545017|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545018|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545019|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545020|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545021|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545022|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545023|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545024|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545025|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545026|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545027|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545028|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545029|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545030|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545031|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545032|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545033|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545034|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545035|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545036|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545037|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545038|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545039|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545040|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545041|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545042|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545043|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545044|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545045|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545046|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545047|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545048|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545049|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545050|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545051|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545052|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545053|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545054|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545055|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545056|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545057|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545058|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545059|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545060|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545061|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545062|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545063|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545064|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545065|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545066|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545067|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545068|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
545069|NCT00653224|E2|Reported Event|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
545070|NCT00653224|E1|Reported Event|Placebo|Matching oral placebo tablet daily for 14 days
545071|NCT00653159|B3|Baseline|Total|Total of all reporting groups
545072|NCT00653159|B2|Baseline|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545073|NCT00653159|B1|Baseline|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545074|NCT00653159|P2|Participant Flow|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545075|NCT00653159|P1|Participant Flow|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545076|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545077|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545078|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545079|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545080|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545081|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545082|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545083|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545084|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545085|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545086|NCT00653159|E2|Reported Event|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
545087|NCT00653159|E1|Reported Event|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
545088|NCT00653133|B3|Baseline|Total|Total of all reporting groups
545089|NCT00653133|B2|Baseline|NSPNB|Stimulator guided nerve block
545090|NCT00653133|B1|Baseline|USPNB|ultrasound imaging guided peripheral nerve block
545091|NCT00653133|P2|Participant Flow|NSPNB|Stimulator guided nerve block
545092|NCT00653133|P1|Participant Flow|USPNB|ultrasound imaging guided peripheral nerve block
545093|NCT00653133|O2|Outcome|NSPNB|Nerve Stimulator guided peripheral nerve block
545094|NCT00653133|O1|Outcome|USPNB|Ultrasound imaging guided peripheral nerve block
545095|NCT00653133|E2|Reported Event|NSPNB|Stimulator guided nerve block
545096|NCT00653133|E1|Reported Event|USPNB|ultrasound imaging guided peripheral nerve block
545097|NCT00653068|B5|Baseline|Total|Total of all reporting groups
545098|NCT00653068|B4|Baseline|Stratum IV|Older children with INI1 mutation only based diagnosis.
545099|NCT00653068|B3|Baseline|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545100|NCT00653068|B2|Baseline|Stratum II|Infants with INI1 mutation only based diagnosis (histology is not consistent with AT/RT).
545101|NCT00653068|B1|Baseline|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545102|NCT00653068|P1|Participant Flow|Treatment|"Within 2-6 weeks after induction therapy or radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers.~Consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses (C) and 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks (R), the order of which depends on patient age, in the absence of disease progression or unacceptable toxicity."
545103|NCT00653068|O1|Outcome|All Patients|Experimental
545104|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545105|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545106|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545107|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545108|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545109|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545110|NCT00653068|E2|Reported Event|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
545111|NCT00653068|E1|Reported Event|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT
545112|NCT00652938|B4|Baseline|Total|Total of all reporting groups
545113|NCT00652938|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545114|NCT00652938|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545115|NCT00652938|B1|Baseline|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545116|NCT00652938|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545117|NCT00652938|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545118|NCT00652938|P1|Participant Flow|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545119|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545120|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545121|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545122|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545123|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545124|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545125|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545126|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545127|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545128|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545129|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545130|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545131|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545132|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545133|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545134|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545135|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545136|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545137|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545138|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545139|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545140|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545141|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545142|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545143|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545144|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545145|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545146|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545147|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545148|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545149|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545150|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545151|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545152|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545153|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545154|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545155|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545156|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545157|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545158|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545159|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545160|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545161|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545162|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545163|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545164|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545165|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545166|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545167|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545168|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545169|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545170|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545171|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545172|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545173|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545174|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545175|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545176|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545177|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545178|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545179|NCT00652938|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545180|NCT00652938|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
545181|NCT00652938|E1|Reported Event|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
545182|NCT00652899|B1|Baseline|All Patients Enrolled|This group includes all patients consented to participate in this study.
545183|NCT00652899|P1|Participant Flow|All Patients Enrolled|This group includes all patients consented to participate in this study.
545184|NCT00652899|O2|Outcome|No Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
545185|NCT00652899|O1|Outcome|Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
545186|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
545187|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
545188|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
545189|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
545190|NCT00652899|O1|Outcome|Ovarian/Fallopian Tube/Peritoneal Cancer Patients|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
545191|NCT00652899|E1|Reported Event|All Patients Enrolled|This group includes all patients consented to participate in this study.
545192|NCT00652834|B1|Baseline|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
545193|NCT00652834|P1|Participant Flow|Kidney Transplant Recipients With GI Symptoms|"Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
545194|NCT00652834|O1|Outcome|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
545195|NCT00652834|E1|Reported Event|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
545196|NCT00652626|B8|Baseline|Total|Total of all reporting groups
545197|NCT00652626|B7|Baseline|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545198|NCT00652626|B6|Baseline|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545199|NCT00652626|B5|Baseline|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545200|NCT00652626|B4|Baseline|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545201|NCT00652626|B3|Baseline|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545202|NCT00652626|B2|Baseline|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545203|NCT00652626|B1|Baseline|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545204|NCT00652626|P7|Participant Flow|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545205|NCT00652626|P6|Participant Flow|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545244|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545206|NCT00652626|P5|Participant Flow|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545207|NCT00652626|P4|Participant Flow|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545208|NCT00652626|P3|Participant Flow|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545209|NCT00652626|P2|Participant Flow|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545210|NCT00652626|P1|Participant Flow|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545211|NCT00652626|O7|Outcome|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545212|NCT00652626|O6|Outcome|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545213|NCT00652626|O5|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545214|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545215|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545216|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545217|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545218|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545219|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545220|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545221|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545222|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545223|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545224|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545225|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545226|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545227|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545228|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545229|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545230|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545231|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545232|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545233|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545234|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545235|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545236|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545237|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545238|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545239|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545240|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545241|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545242|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545243|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545740|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545245|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545246|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545247|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545248|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545249|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545250|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545251|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545252|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545253|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545254|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545255|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545256|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545257|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545258|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545259|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545260|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545261|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545262|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545263|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545264|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545265|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545266|NCT00652626|E7|Reported Event|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545267|NCT00652626|E6|Reported Event|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
545268|NCT00652626|E5|Reported Event|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545269|NCT00652626|E4|Reported Event|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
545270|NCT00652626|E3|Reported Event|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
545271|NCT00652626|E2|Reported Event|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
545272|NCT00652626|E1|Reported Event|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
545273|NCT00652366|B6|Baseline|Total|Total of all reporting groups
545274|NCT00652366|B5|Baseline|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
545275|NCT00652366|B4|Baseline|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545285|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
546564|NCT00646958|P2|Participant Flow|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
545276|NCT00652366|B3|Baseline|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545277|NCT00652366|B2|Baseline|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545278|NCT00652366|B1|Baseline|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545279|NCT00652366|P5|Participant Flow|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
545280|NCT00652366|P4|Participant Flow|G+E: No Rash Non-Eligibl|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545281|NCT00652366|P3|Participant Flow|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 milligrams per day (mg/day), PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade ≥ 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545282|NCT00652366|P2|Participant Flow|G+E Standard Dose: Rash Grade Less Than (<) 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545283|NCT00652366|P1|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545284|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545354|NCT00652145|B1|Baseline|Increase Mesalamine Dose|Participants were randomized to increase dose of mesalamine by 2.4 gm per day over their baseline dose
545355|NCT00652145|P2|Participant Flow|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
545356|NCT00652145|P1|Participant Flow|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
545357|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
545286|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545287|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545288|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545289|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545290|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545291|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545292|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545293|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545294|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545358|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
545359|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
545360|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
545295|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545296|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545297|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545298|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545299|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545300|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545301|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545302|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545303|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545361|NCT00652145|O2|Outcome|Maintain Mesalmine Dose|Maintain current mesalamine dose at 2.4 g/day
545304|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545305|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545306|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545307|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months
545308|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545309|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545310|NCT00652366|E5|Reported Event|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
545311|NCT00652366|E4|Reported Event|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545312|NCT00652366|E3|Reported Event|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545362|NCT00652145|O1|Outcome|Increase Mesalamine Dose by 2.4g/Day|"Increase dose of mesalamine by 2.4 gm per day~mesalamine: Increase dose by 2.4gm per day over baseline dose"
545363|NCT00652145|E2|Reported Event|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
545313|NCT00652366|E2|Reported Event|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
545314|NCT00652366|E1|Reported Event|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
545315|NCT00652340|B3|Baseline|Total|Total of all reporting groups
545316|NCT00652340|B2|Baseline|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
545317|NCT00652340|B1|Baseline|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
545318|NCT00652340|P2|Participant Flow|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
545319|NCT00652340|P1|Participant Flow|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
545320|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
545321|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
545322|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
545323|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
545324|NCT00652340|E2|Reported Event|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
545325|NCT00652340|E1|Reported Event|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
545326|NCT00652327|B3|Baseline|Total|Total of all reporting groups
545327|NCT00652327|B2|Baseline|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545328|NCT00652327|B1|Baseline|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545329|NCT00652327|P2|Participant Flow|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545330|NCT00652327|P1|Participant Flow|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545331|NCT00652327|O2|Outcome|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545332|NCT00652327|O1|Outcome|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545333|NCT00652327|E2|Reported Event|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545334|NCT00652327|E1|Reported Event|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
545335|NCT00652314|B3|Baseline|Total|Total of all reporting groups
545336|NCT00652314|B2|Baseline|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545337|NCT00652314|B1|Baseline|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545338|NCT00652314|P2|Participant Flow|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545339|NCT00652314|P1|Participant Flow|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545340|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545341|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545342|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545343|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545344|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545345|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545346|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545347|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545348|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545349|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545350|NCT00652314|E2|Reported Event|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545351|NCT00652314|E1|Reported Event|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
545352|NCT00652145|B3|Baseline|Total|Total of all reporting groups
545353|NCT00652145|B2|Baseline|Maintain Mesalamine Dose|Participants were randomized to maintain their baseline mesalamine dose
546565|NCT00646958|P1|Participant Flow|Radezolid QD|450 mg by mouth (PO) once daily (QD)
545364|NCT00652145|E1|Reported Event|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
545365|NCT00652093|B7|Baseline|Total|Total of all reporting groups
545366|NCT00652093|B6|Baseline|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545367|NCT00652093|B5|Baseline|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545368|NCT00652093|B4|Baseline|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545369|NCT00652093|B3|Baseline|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545370|NCT00652093|B2|Baseline|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545371|NCT00652093|B1|Baseline|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545372|NCT00652093|P6|Participant Flow|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545373|NCT00652093|P5|Participant Flow|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545374|NCT00652093|P4|Participant Flow|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545375|NCT00652093|P3|Participant Flow|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545376|NCT00652093|P2|Participant Flow|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545377|NCT00652093|P1|Participant Flow|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545378|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545379|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545380|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545381|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545382|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545383|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545384|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545385|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545386|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545387|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545388|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545389|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545390|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545391|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545392|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545393|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545394|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545395|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545396|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545397|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545398|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545399|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545400|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545401|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545402|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545403|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545404|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545405|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545406|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545407|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545408|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545409|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545410|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545411|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545412|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545413|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545414|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545415|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545416|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545417|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545418|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545419|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545420|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545421|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545422|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545423|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545424|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545425|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545426|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545427|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545428|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545429|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545430|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545431|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545432|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545433|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545434|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545435|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545436|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545437|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545438|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545439|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545440|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545441|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545442|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545443|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545444|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545445|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545446|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545447|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545448|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545449|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545450|NCT00652093|E6|Reported Event|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545451|NCT00652093|E5|Reported Event|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545452|NCT00652093|E4|Reported Event|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
545453|NCT00652093|E3|Reported Event|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545454|NCT00652093|E2|Reported Event|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
545455|NCT00652093|E1|Reported Event|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
545456|NCT00652028|B5|Baseline|Total|Total of all reporting groups
545457|NCT00652028|B4|Baseline|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545458|NCT00652028|B3|Baseline|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545459|NCT00652028|B2|Baseline|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545460|NCT00652028|B1|Baseline|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545461|NCT00652028|P4|Participant Flow|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545462|NCT00652028|P3|Participant Flow|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545463|NCT00652028|P2|Participant Flow|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545464|NCT00652028|P1|Participant Flow|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545465|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545466|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545467|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545468|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545469|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545470|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545471|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545472|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545473|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545474|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545475|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545476|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545477|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545478|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545479|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545480|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545481|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545553|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
545482|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545483|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545484|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545485|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545486|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545487|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545488|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545489|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545490|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545491|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545492|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545493|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545494|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545495|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545496|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545497|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545498|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545499|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545500|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545501|NCT00652028|E4|Reported Event|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
545502|NCT00652028|E3|Reported Event|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
545503|NCT00652028|E2|Reported Event|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
545504|NCT00652028|E1|Reported Event|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
545505|NCT00651924|B3|Baseline|Total|Total of all reporting groups
545506|NCT00651924|B2|Baseline|Phase 2|Pilot IVR-based Cognitive-behavior therapy: Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
545507|NCT00651924|B1|Baseline|Phase 1|Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are.
545508|NCT00651924|P2|Participant Flow|Phase 2|Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials.
545509|NCT00651924|P1|Participant Flow|Phase 1|Review of materials and provide feedback regarding how understandable, engaging, and informative the materials are. Revisions will be made based on this feedback.
545510|NCT00651924|O2|Outcome|Phase 2|Pilot IVR-based CBT treatment
545511|NCT00651924|O1|Outcome|Phase 1|Qualitative interviews
545512|NCT00651924|E2|Reported Event|Phase 2|Pilot the newly developed materials during a 10-week course of cognitive behavioral therapy for chronic pain
545513|NCT00651924|E1|Reported Event|Phase 1|Review of newly created materials and provide feedback regarding how understandable, engaging, and informative the materials are.
545514|NCT00651820|B1|Baseline|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
545515|NCT00651820|P1|Participant Flow|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
545516|NCT00651820|O2|Outcome|Vehicle Rate of Wound Closure|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
545517|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
545518|NCT00651820|O2|Outcome|Vehicle Rate to Complete Wound Healing|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
545741|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545519|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
545520|NCT00651820|E1|Reported Event|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
545521|NCT00651794|B4|Baseline|Total|Total of all reporting groups
545522|NCT00651794|B3|Baseline|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545523|NCT00651794|B2|Baseline|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545524|NCT00651794|B1|Baseline|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545525|NCT00651794|P3|Participant Flow|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545526|NCT00651794|P2|Participant Flow|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545527|NCT00651794|P1|Participant Flow|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545528|NCT00651794|O3|Outcome|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545529|NCT00651794|O2|Outcome|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545530|NCT00651794|O1|Outcome|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545531|NCT00651794|O3|Outcome|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545532|NCT00651794|O2|Outcome|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545533|NCT00651794|O1|Outcome|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545534|NCT00651794|O3|Outcome|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545535|NCT00651794|O2|Outcome|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545536|NCT00651794|O1|Outcome|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545537|NCT00651794|O3|Outcome|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545538|NCT00651794|O2|Outcome|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545539|NCT00651794|O1|Outcome|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545540|NCT00651794|O3|Outcome|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545541|NCT00651794|O2|Outcome|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545542|NCT00651794|O1|Outcome|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545543|NCT00651794|E3|Reported Event|NRP With HFT and Team Training|Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
545544|NCT00651794|E2|Reported Event|NRP With LFT and Team Training|Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
545545|NCT00651794|E1|Reported Event|Control (NRP Curriculum With LFT and no Team Training)|Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
545546|NCT00651755|B1|Baseline|Entire Study Population|Participants randomized to Aprepitant or control (Standard of Care) in Cycle 1 crossover for different treatment in Cycle 2.
545547|NCT00651755|P2|Participant Flow|First No Aprepritant Cycle 1, Then Aprepitant Cycle 2|First No Aprepitant in Cycle 1, then Aprepitant 125 mg oral (PO) Day 1 of Cycle 2 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above].
545548|NCT00651755|P1|Participant Flow|First Aprepitant Cycle 1 Then No Aprepitant Cycle 2|"First Aprepitant with CHOP or R-CHOP (CHOP plus Rituximab 375 mg/m^2 intravenous Day 1) then No Aprepitant in Cycle 2.~Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above]."
545549|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
545550|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
545551|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
545552|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
546566|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
545554|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
545555|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
545556|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
545557|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
545558|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
545559|NCT00651755|O2|Outcome|Control Group|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
545560|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
545561|NCT00651755|E2|Reported Event|Control|Standard of Care
545562|NCT00651755|E1|Reported Event|Aprepitant|Aprepitant 125 mg oral (PO) Day 1 (Cycle 1 or Cycle 2) to include treated study population.
545563|NCT00651625|B3|Baseline|Total|Total of all reporting groups
545564|NCT00651625|B2|Baseline|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545565|NCT00651625|B1|Baseline|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545566|NCT00651625|P2|Participant Flow|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545567|NCT00651625|P1|Participant Flow|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545568|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545569|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545570|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545582|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545571|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545572|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545573|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545574|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545575|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545576|NCT00651625|E2|Reported Event|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545577|NCT00651625|E1|Reported Event|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
545578|NCT00651482|B1|Baseline|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
545579|NCT00651482|P1|Participant Flow|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
545580|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545581|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545733|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545583|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545584|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545585|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545586|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545587|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
545588|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545589|NCT00651482|E1|Reported Event|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
545590|NCT00651313|B3|Baseline|Total|Total of all reporting groups
545591|NCT00651313|B2|Baseline|Placebo|Placebo vaginal gel
545592|NCT00651313|B1|Baseline|Active|Lidocaine 10% (150mg) vaginal gel
545593|NCT00651313|P2|Participant Flow|Placebo|Placebo vaginal gel
545594|NCT00651313|P1|Participant Flow|Active|Lidocaine 10% (150mg) vaginal gel
545595|NCT00651313|O2|Outcome|Placebo Gel|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
545596|NCT00651313|O1|Outcome|Lidocaine 10%|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
545597|NCT00651313|E2|Reported Event|Placebo|Placebo vaginal gel
545598|NCT00651313|E1|Reported Event|Active|Lidocaine 10% (150mg) vaginal gel
545599|NCT00651261|B3|Baseline|Total|Total of all reporting groups
545600|NCT00651261|B2|Baseline|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545601|NCT00651261|B1|Baseline|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545602|NCT00651261|P2|Participant Flow|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545603|NCT00651261|P1|Participant Flow|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545604|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545605|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545734|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545606|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545607|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545608|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545609|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545610|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545611|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545612|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545613|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545614|NCT00651261|E2|Reported Event|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
545615|NCT00651261|E1|Reported Event|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
545616|NCT00651183|B3|Baseline|Total|Total of all reporting groups
545617|NCT00651183|B2|Baseline|Advanced PD|Advanced Parkinson's Disease (PD) patients
545618|NCT00651183|B1|Baseline|Early PD|Early Parkinson's Disease (PD) patients
545619|NCT00651183|P2|Participant Flow|Advanced PD|Advanced Parkinson's Disease (PD) patients
545620|NCT00651183|P1|Participant Flow|Early (PD)|Early Parkinson's Disease (PD) patients
545621|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
545622|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
545623|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
545624|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
545625|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
545626|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
545627|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
545628|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
545629|NCT00651183|E2|Reported Event|Advanced PD|Advanced Parkinson's Disease (PD) patients
545630|NCT00651183|E1|Reported Event|Early PD|Early Parkinson's Disease (PD) patients
545631|NCT00651157|B1|Baseline|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
545735|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545632|NCT00651157|P1|Participant Flow|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
545633|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
545634|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
545635|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
545636|NCT00651157|E1|Reported Event|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
545637|NCT00651118|B5|Baseline|Total|Total of all reporting groups
545638|NCT00651118|B4|Baseline|Placebo|placebo nasal spray
545639|NCT00651118|B3|Baseline|Azelastine HCl|azelastine HCl nasal spray nasal spray
545640|NCT00651118|B2|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
545641|NCT00651118|B1|Baseline|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
545642|NCT00651118|P4|Participant Flow|Placebo|placebo nasal spray
545643|NCT00651118|P3|Participant Flow|Azelastine HCl|azelastine HCl nasal spray nasal spray
545644|NCT00651118|P2|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
545645|NCT00651118|P1|Participant Flow|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
545646|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
545647|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
545648|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
545649|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
545650|NCT00651118|O4|Outcome|Placebo|Placebo nasal spray
545651|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray
545652|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
545653|NCT00651118|O1|Outcome|MP29-02|fluticasone propionate 50 mcg / azelastine HCl 137 mcg nasal spray
545654|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
545655|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
545656|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
545657|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
545658|NCT00651118|E4|Reported Event|Placebo|placebo nasal spray
545659|NCT00651118|E3|Reported Event|Azelastine HCl|azelastine HCl nasal spray nasal spray
545660|NCT00651118|E2|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
545661|NCT00651118|E1|Reported Event|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
545662|NCT00651040|B3|Baseline|Total|Total of all reporting groups
545663|NCT00651040|B2|Baseline|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
545664|NCT00651040|B1|Baseline|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
545665|NCT00651040|P2|Participant Flow|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
545666|NCT00651040|P1|Participant Flow|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
545667|NCT00651040|O2|Outcome|Prednison Methotrexate 2|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
545668|NCT00651040|O1|Outcome|Prednison1|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
545736|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545737|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545738|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545739|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545669|NCT00651040|E2|Reported Event|2 Prednison Methotrexate|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
545670|NCT00651040|E1|Reported Event|1 Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
545671|NCT00650858|B4|Baseline|Total|Total of all reporting groups
545672|NCT00650858|B3|Baseline|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545673|NCT00650858|B2|Baseline|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545674|NCT00650858|B1|Baseline|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545675|NCT00650858|P3|Participant Flow|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545676|NCT00650858|P2|Participant Flow|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545677|NCT00650858|P1|Participant Flow|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545678|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545679|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545680|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545681|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545682|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545683|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545684|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545685|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545686|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545687|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545688|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545689|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545690|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545691|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545692|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545693|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545694|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545695|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545696|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545697|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545698|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545699|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545700|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545701|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545702|NCT00650858|E3|Reported Event|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
545703|NCT00650858|E2|Reported Event|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
545704|NCT00650858|E1|Reported Event|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
545705|NCT00650845|B3|Baseline|Total|Total of all reporting groups
545706|NCT00650845|B2|Baseline|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545707|NCT00650845|B1|Baseline|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
545708|NCT00650845|P2|Participant Flow|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545709|NCT00650845|P1|Participant Flow|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
545710|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545711|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
545712|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545713|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
545714|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545715|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
545716|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545717|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
545718|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545719|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
545720|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545721|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
545722|NCT00650845|E2|Reported Event|Non-enhanced MRI|non-enhanced MRI: non injected MRI
545723|NCT00650845|E1|Reported Event|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
545724|NCT00650806|B5|Baseline|Total|Total of all reporting groups
545725|NCT00650806|B4|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545726|NCT00650806|B3|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545727|NCT00650806|B2|Baseline|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545728|NCT00650806|B1|Baseline|Placebo|Each patient received matching placebo once daily for 12 weeks.
545729|NCT00650806|P4|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks.
545730|NCT00650806|P3|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545731|NCT00650806|P2|Participant Flow|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545732|NCT00650806|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 12 weeks.
545742|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545743|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545744|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545745|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545746|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545747|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545748|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545749|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545750|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545751|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545752|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545753|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545754|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545755|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545756|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545757|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545758|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545759|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545760|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545761|NCT00650806|O4|Outcome|Canaglifloziin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545762|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545763|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545764|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
545765|NCT00650806|E4|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545766|NCT00650806|E3|Reported Event|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545767|NCT00650806|E2|Reported Event|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
545768|NCT00650806|E1|Reported Event|Placebo|Each patient received matching placebo once daily for 12 weeks.
545769|NCT00650767|B5|Baseline|Total|Total of all reporting groups
545770|NCT00650767|B4|Baseline|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545771|NCT00650767|B3|Baseline|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545772|NCT00650767|B2|Baseline|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545773|NCT00650767|B1|Baseline|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545774|NCT00650767|P4|Participant Flow|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545775|NCT00650767|P3|Participant Flow|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545776|NCT00650767|P2|Participant Flow|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545777|NCT00650767|P1|Participant Flow|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545778|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545779|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545780|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545781|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545782|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545783|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545784|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545785|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545786|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545787|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545788|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545789|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545790|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545791|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545792|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545793|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545794|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545795|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545796|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545797|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545798|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545799|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545800|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545801|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545802|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545803|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545804|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545805|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545806|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545807|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545808|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545809|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545810|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545811|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545812|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545813|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545814|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545815|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545816|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545817|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545818|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545819|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545820|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545821|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545822|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545823|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545824|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545825|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545826|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545827|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545828|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545829|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545830|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545831|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545832|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545833|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545834|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545835|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545836|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545837|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545838|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545839|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545840|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545841|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545842|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545843|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545844|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545845|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545846|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545847|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545848|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545849|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545850|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545851|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545852|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545853|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545854|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545855|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545856|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545857|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545858|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545859|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545860|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545861|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545862|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545863|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545864|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545865|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545866|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545867|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545868|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545869|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545870|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545871|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545872|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545873|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545874|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545875|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545876|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545877|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545878|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545879|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545880|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545881|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545882|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545883|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545884|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545885|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545886|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545887|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545888|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545889|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545890|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545891|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545892|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545893|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545894|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545895|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545896|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545897|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545898|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545899|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545900|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545901|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545902|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545903|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545904|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545905|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545906|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545907|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545908|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545909|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545910|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545911|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545912|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545913|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545914|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545915|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545916|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545917|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545918|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545919|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545920|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545921|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545922|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545923|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545924|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545925|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545926|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545927|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545928|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545929|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545930|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545931|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545932|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545933|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545934|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545935|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545936|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545937|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545938|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545939|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545940|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545941|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545942|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545943|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545944|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545945|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545946|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545947|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545948|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545949|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545950|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545951|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545952|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545953|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545954|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545955|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545956|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545957|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545958|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545959|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545960|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545961|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545962|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545963|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545964|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545965|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545966|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545967|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545968|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545969|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545970|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545971|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545972|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545973|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545974|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545975|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545976|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545977|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545978|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545979|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545980|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545981|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545982|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545983|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545984|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545985|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545986|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545987|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545988|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545989|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545990|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545991|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545992|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545993|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545994|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545995|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545996|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545997|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
545998|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
545999|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546000|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546001|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546002|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546003|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546004|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546005|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546006|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546007|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546008|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546009|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546010|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546011|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546012|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546013|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546014|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546015|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546016|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546017|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546018|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546019|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546020|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546021|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546022|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546023|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546024|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546025|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546026|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546027|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546028|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546029|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546030|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546031|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546032|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546033|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546034|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546035|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546036|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546037|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546038|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546039|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546040|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546041|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546042|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546043|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546044|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546045|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546046|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546047|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546048|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546049|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546050|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546051|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546052|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546053|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546054|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546055|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546056|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546057|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546058|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546059|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546060|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546061|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546062|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546063|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546064|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546065|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546066|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546067|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546068|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546069|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546070|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546071|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546072|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546073|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546074|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546075|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546076|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546077|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546078|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546079|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546080|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546081|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546082|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546083|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546084|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546085|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546086|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546087|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546088|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546089|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546090|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546091|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546092|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546093|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546094|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546095|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546096|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546097|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546098|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546099|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546100|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546101|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546102|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546103|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546104|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546105|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546106|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546107|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546108|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546109|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546110|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546111|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546112|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546113|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546114|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546115|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546116|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546117|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546118|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546119|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546120|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546121|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546122|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546123|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546124|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546125|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546126|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546127|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546128|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546129|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546130|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546131|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546132|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546133|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546134|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546135|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546136|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546137|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546138|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546139|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546140|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546141|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546142|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546143|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546144|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546145|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546146|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546147|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546148|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546149|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546150|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546151|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546152|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546153|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546154|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546155|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546156|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546157|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546158|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546159|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546160|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546161|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546162|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546163|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546164|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546165|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546166|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546167|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546168|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546169|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546170|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546171|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546172|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546173|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546174|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546175|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546176|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546177|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546178|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546179|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546180|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546181|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546182|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546183|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546184|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546185|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546186|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546187|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546188|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546189|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546190|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546191|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546192|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546193|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546194|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546195|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546196|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546197|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546198|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546199|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546200|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546201|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546202|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546203|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546204|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546205|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546206|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546207|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546208|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546209|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546210|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546211|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546212|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546213|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546214|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546215|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546216|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546217|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546218|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546219|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546220|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546221|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546222|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546223|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546224|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546225|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546226|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546227|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546228|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546229|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546230|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546231|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546232|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546233|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546234|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546235|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546236|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546237|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546238|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546239|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546240|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546241|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546242|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546243|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546244|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546245|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546246|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546247|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546248|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546249|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546250|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546251|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546252|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546253|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546254|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546255|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546256|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546257|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546258|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546259|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546260|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546261|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546262|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546263|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546264|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546265|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546266|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546267|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546268|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546269|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546270|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546271|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546272|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546273|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546274|NCT00650767|E4|Reported Event|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546275|NCT00650767|E3|Reported Event|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546276|NCT00650767|E2|Reported Event|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
546277|NCT00650767|E1|Reported Event|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
546278|NCT00650585|B3|Baseline|Total|Total of all reporting groups
546279|NCT00650585|B2|Baseline|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546280|NCT00650585|B1|Baseline|Control Group|School did not receive Project ALERT, a substance use prevention program
546281|NCT00650585|P2|Participant Flow|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546282|NCT00650585|P1|Participant Flow|Control Group|School did not receive Project ALERT, a substance use prevention program
546283|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546284|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546285|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546286|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546287|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546288|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546289|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546290|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546291|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546292|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546293|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546294|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546295|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546296|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546346|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546297|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546298|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
546299|NCT00650585|E2|Reported Event|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
546300|NCT00650585|E1|Reported Event|Control Group|School did not receive Project ALERT, a substance use prevention program
546301|NCT00650546|B1|Baseline|Open-labeled Prospective Case Series|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide: 5 mcg twice a day titrated to 10 mcg twice a day"
546302|NCT00650546|P1|Participant Flow|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
546303|NCT00650546|O1|Outcome|Individuals Who Recieved Treatment With Exenatide|change of NAS score in eight adult patients with known type 2 DM and biopsy proven NAFLD after treatment with exenatide
546304|NCT00650546|O1|Outcome|Treatment With Exenatide|eight adult patients with known type 2 DM and biopsy proven NAFLD
546305|NCT00650546|E1|Reported Event|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
546306|NCT00650260|B3|Baseline|Total|Total of all reporting groups
546307|NCT00650260|B2|Baseline|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546308|NCT00650260|B1|Baseline|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546309|NCT00650260|P2|Participant Flow|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546310|NCT00650260|P1|Participant Flow|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546311|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546312|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546313|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546343|NCT00650091|P1|Participant Flow|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546344|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546314|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546315|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546316|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546317|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546318|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546319|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546320|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546321|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546322|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546341|NCT00650091|P3|Participant Flow|Pred/AZA/NAC|"The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.~The azathioprine dose (maximum, 150 mg per day) was based on the patient’s ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day."
546342|NCT00650091|P2|Participant Flow|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546323|NCT00650260|E2|Reported Event|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546324|NCT00650260|E1|Reported Event|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
546325|NCT00650104|B1|Baseline|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546326|NCT00650104|P1|Participant Flow|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546327|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546328|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546329|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546330|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546474|NCT00648115|E1|Reported Event|Arm 1|Basic vocational services but no manualized vocational program
546331|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546332|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546333|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546334|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546335|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546336|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546337|NCT00650104|E1|Reported Event|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
546338|NCT00650091|B3|Baseline|Total|Total of all reporting groups
546339|NCT00650091|B2|Baseline|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546340|NCT00650091|B1|Baseline|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546345|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546347|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546348|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546349|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546350|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546351|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546352|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546353|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546354|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546355|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546356|NCT00650091|E4|Reported Event|Initial Study: Placebo|Placebo: Participants will receive placebo each day.
546357|NCT00650091|E3|Reported Event|Initial Study: Pred/AZA/NAC|Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
546358|NCT00650091|E2|Reported Event|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
546359|NCT00650091|E1|Reported Event|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
546360|NCT00650078|B3|Baseline|Total|Total of all reporting groups
546361|NCT00650078|B2|Baseline|Placebo|
546362|NCT00650078|B1|Baseline|NP01|Modified Release (MR) prednisone 5 mg
546363|NCT00650078|P2|Participant Flow|Placebo|
546364|NCT00650078|P1|Participant Flow|NP01|Modified Release (MR) prednisone 5 mg
546365|NCT00650078|O2|Outcome|Placebo|
546366|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
546367|NCT00650078|O2|Outcome|Placebo|
546368|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
546369|NCT00650078|E2|Reported Event|Placebo|
546370|NCT00650078|E1|Reported Event|NP01|Modified Release (MR) prednisone 5 mg
546371|NCT00649961|B1|Baseline|Single Arm|open label dose finding study
546372|NCT00649961|P1|Participant Flow|Melatonin Open Label Single Arm|Open label single arm study
546373|NCT00649961|O1|Outcome|Single Arm|open label dose finding study
546374|NCT00649961|E1|Reported Event|Single Arm|open label dose finding study
546375|NCT00649792|B1|Baseline|Fampridine-SR|Tablets, 10 mg, BID
546376|NCT00649792|P1|Participant Flow|Fampridine-SR|Tablets, 10 mg, BID
546377|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
546378|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
546379|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
546380|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
546381|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
546382|NCT00649792|E1|Reported Event|Fampridine-SR|Tablets, 10 mg, BID
546383|NCT00649428|B3|Baseline|Total|Total of all reporting groups
546384|NCT00649428|B2|Baseline|Placebo|Patients treated with placebo solution
546385|NCT00649428|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
546386|NCT00649428|P2|Participant Flow|Placebo|Patients treated with placebo solution
546387|NCT00649428|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
546388|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
546389|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
546390|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
546391|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
546392|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
546393|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
546394|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
546395|NCT00649428|O1|Outcome|Autologous Fibroblast|Patients treated with autologous fibroblasts (azficel-T).
546396|NCT00649428|E2|Reported Event|Placebo|Patients treated with placebo solution.
546397|NCT00649428|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
546398|NCT00649389|B5|Baseline|Total|Total of all reporting groups
546399|NCT00649389|B4|Baseline|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
546400|NCT00649389|B3|Baseline|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546401|NCT00649389|B2|Baseline|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546402|NCT00649389|B1|Baseline|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
546403|NCT00649389|P4|Participant Flow|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
546404|NCT00649389|P3|Participant Flow|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546405|NCT00649389|P2|Participant Flow|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546406|NCT00649389|P1|Participant Flow|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
546407|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
546408|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546409|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546410|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
546411|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
546412|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546413|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546414|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
546415|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
546416|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546417|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546418|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
546419|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
546420|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546421|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546422|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
546423|NCT00649389|E4|Reported Event|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
546424|NCT00649389|E3|Reported Event|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546425|NCT00649389|E2|Reported Event|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
546426|NCT00649389|E1|Reported Event|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
546427|NCT00649220|B1|Baseline|Memantine|Memantine tablets, twice a day (bid).
546428|NCT00649220|P1|Participant Flow|Memantine|Memantine tablets, twice a day (bid).
546429|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546430|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546431|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546432|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546433|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546434|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546435|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546436|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
546437|NCT00649220|E1|Reported Event|Memantine|Memantine tablets, twice a day (bid).
546438|NCT00648908|B1|Baseline|Fampridine-SR|Tablets, 10mg twice daily
546439|NCT00648908|P1|Participant Flow|Fampridine-SR|Tablets, 10mg twice daily
546440|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
546441|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
546442|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
546443|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
546444|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
546445|NCT00648908|E1|Reported Event|Fampridine-SR|Tablets, 10mg twice daily
546446|NCT00648895|B3|Baseline|Total|Total of all reporting groups
546447|NCT00648895|B2|Baseline|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
546448|NCT00648895|B1|Baseline|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
546449|NCT00648895|P2|Participant Flow|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
546450|NCT00648895|P1|Participant Flow|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
546451|NCT00648895|O2|Outcome|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
546452|NCT00648895|O1|Outcome|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
546453|NCT00648895|E2|Reported Event|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
546563|NCT00646958|P3|Participant Flow|Linezolid BID|600 mg by mouth (PO) BID
546454|NCT00648895|E1|Reported Event|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
546455|NCT00648167|B1|Baseline|KRX-0502|Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)
546456|NCT00648167|P1|Participant Flow|KRX-0502|Ferric Citrate
546457|NCT00648167|O1|Outcome|KRX-0502 (Ferric Citrate)|Patients starting dose of 4.5 grams per day (n=34) and those starting on 6.0 grams per day (n=21)- immediate roll over from previous phosphate binder(s)
546458|NCT00648167|E1|Reported Event|KRX-0502|"Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)~Intent-to-Treat (ITT)"
546459|NCT00648115|B4|Baseline|Total|Total of all reporting groups
546460|NCT00648115|B3|Baseline|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546461|NCT00648115|B2|Baseline|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546462|NCT00648115|B1|Baseline|Basic Vocational Services|Basic vocational services but no manualized vocational program
546463|NCT00648115|P3|Participant Flow|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546464|NCT00648115|P2|Participant Flow|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546465|NCT00648115|P1|Participant Flow|Basic Vocational Services|Basic vocational services but no manualized vocational program
546466|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546467|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546468|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
546469|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546470|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546471|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
546472|NCT00648115|E3|Reported Event|Arm 3|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546473|NCT00648115|E2|Reported Event|Arm 2|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
546475|NCT00648037|B1|Baseline|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
546476|NCT00648037|P1|Participant Flow|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
546477|NCT00648037|O1|Outcome|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
546478|NCT00648037|E1|Reported Event|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
546479|NCT00647998|B3|Baseline|Total|Total of all reporting groups
546480|NCT00647998|B2|Baseline|Standard Care|No darbepoetin
546481|NCT00647998|B1|Baseline|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
546482|NCT00647998|P2|Participant Flow|Standard Care|No darbepoetin
546483|NCT00647998|P1|Participant Flow|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
546484|NCT00647998|O2|Outcome|Standard Care|No darbepoetin
546485|NCT00647998|O1|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
546486|NCT00647998|O2|Outcome|Standard Care|"No Darbepoetin~Standard care"
546487|NCT00647998|O1|Outcome|Darbepoetin|"Patients received 1mg/kg IV Darbepoetin immediately prior to surgery~Darbepoetin alfa: Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery~Standard care"
546488|NCT00647998|O2|Outcome|Standard Care|No darbepoetin
546489|NCT00647998|O1|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
546490|NCT00647998|E2|Reported Event|Standard Care|No darbepoetin
546491|NCT00647998|E1|Reported Event|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
546492|NCT00647699|B3|Baseline|Total|Total of all reporting groups
546493|NCT00647699|B2|Baseline|Control Group|riboflavin ophthalmic solution without UVA irradiation
546494|NCT00647699|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
546495|NCT00647699|P2|Participant Flow|Control Group|riboflavin ophthalmic solution without UVA irradiation
546496|NCT00647699|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
546497|NCT00647699|O2|Outcome|Control Group|riboflavin ophthalmic solution without UVA irradiation
546498|NCT00647699|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
546499|NCT00647699|E2|Reported Event|Control Group|riboflavin ophthalmic solution without UVA irradiation
546500|NCT00647699|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
546501|NCT00647556|B3|Baseline|Total|Total of all reporting groups
546502|NCT00647556|B2|Baseline|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546503|NCT00647556|B1|Baseline|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546504|NCT00647556|P2|Participant Flow|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546505|NCT00647556|P1|Participant Flow|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546506|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546507|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546508|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546509|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546510|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546511|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546512|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546513|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546514|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546515|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546516|NCT00647556|E2|Reported Event|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
546517|NCT00647556|E1|Reported Event|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
546518|NCT00647400|B3|Baseline|Total|Total of all reporting groups
546519|NCT00647400|B2|Baseline|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
546520|NCT00647400|B1|Baseline|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
546521|NCT00647400|P2|Participant Flow|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
546522|NCT00647400|P1|Participant Flow|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
546523|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
546524|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
546525|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
546526|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
546527|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
546528|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
546529|NCT00647400|E2|Reported Event|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
546530|NCT00647400|E1|Reported Event|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
546531|NCT00647270|B4|Baseline|Total|Total of all reporting groups
546532|NCT00647270|B3|Baseline|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
546533|NCT00647270|B2|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
546534|NCT00647270|B1|Baseline|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546535|NCT00647270|P3|Participant Flow|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
546536|NCT00647270|P2|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
546537|NCT00647270|P1|Participant Flow|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546538|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
546539|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
546540|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546541|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
546542|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
546543|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546544|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
546545|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
546546|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546547|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
546548|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
546549|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546550|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
546551|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
546552|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546553|NCT00647270|E6|Reported Event|Adalimumab 80 mg Monthly - Period 2|Adalimumab 80 mg monthly for Period 1 and Period 2
546554|NCT00647270|E5|Reported Event|Adalimumab 40 mg Eow-Period 2|Adalimumab 40 mg eow for Period 1 and Period 2
546555|NCT00647270|E4|Reported Event|Placebo/Adalimumab 40 mg Eow-Period 2|Placebo 40 mg eow for Period 1 (weeks 1-12) Subjects switched to Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546556|NCT00647270|E3|Reported Event|Adalimumab 80 mg Monthly-Period 1|Adalimumab 80 mg monthly for Period 1 and Period 2
546557|NCT00647270|E2|Reported Event|Adalimumab 40 mg Eow -Period 1|Adalimumab 40 mg eow for Period 1 and Period 2
546558|NCT00647270|E1|Reported Event|Placebo Every Other Week (Eow)-Period 1|Placebo eow for 12 weeks for Period 1 Adalimumab 40 mg eow for remaining 12 weeks for Period 2
546559|NCT00646958|B4|Baseline|Total|Total of all reporting groups
546560|NCT00646958|B3|Baseline|Linezolid BID|600 mg by mouth (PO) BID
546561|NCT00646958|B2|Baseline|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
546562|NCT00646958|B1|Baseline|Radezolid QD|450 mg by mouth (PO) once daily (QD)
546567|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
546568|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
546569|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
546570|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
546571|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
546572|NCT00646958|E3|Reported Event|Linezolid BID|600 mg by mouth (PO) BID
546573|NCT00646958|E2|Reported Event|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
546574|NCT00646958|E1|Reported Event|Radezolid QD|450 mg by mouth (PO) once daily (QD)
546575|NCT00646776|B3|Baseline|Total|Total of all reporting groups
546576|NCT00646776|B2|Baseline|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546577|NCT00646776|B1|Baseline|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546578|NCT00646776|P2|Participant Flow|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546579|NCT00646776|P1|Participant Flow|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546580|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546581|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546582|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546583|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546584|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546585|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546586|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546587|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546588|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546589|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546590|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546631|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
546814|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
546591|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546592|NCT00646776|O3|Outcome|RIB 300 mg QD|AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD.
546593|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QAD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546594|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546595|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546596|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546597|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546598|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546599|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546600|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546601|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546602|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546603|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546604|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546605|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546606|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546607|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546608|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546815|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
546609|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546610|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546611|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546612|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546613|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546614|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546615|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546616|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546617|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546618|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546619|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546620|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546621|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546622|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
546623|NCT00646776|E2|Reported Event|RIB 150mg|
546624|NCT00646776|E1|Reported Event|ATV/RTV 300/100mg+RIB 150mg|
546625|NCT00646763|B3|Baseline|Total|Total of all reporting groups
546626|NCT00646763|B2|Baseline|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
546627|NCT00646763|B1|Baseline|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
546628|NCT00646763|P2|Participant Flow|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
546629|NCT00646763|P1|Participant Flow|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
546630|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
546632|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
546633|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
546634|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
546635|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
546636|NCT00646763|E2|Reported Event|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
546637|NCT00646763|E1|Reported Event|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
546638|NCT00646646|B5|Baseline|Total|Total of all reporting groups
546639|NCT00646646|B4|Baseline|Propofol|"active drug~propofol : sedative"
546640|NCT00646646|B3|Baseline|Placebo|"placebo control~saline placebo : saline placebo"
546641|NCT00646646|B2|Baseline|Midazolam|"Sedative~Midazolam : sedative"
546642|NCT00646646|B1|Baseline|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
546643|NCT00646646|P4|Participant Flow|Propofol|Sedative Drug 3
546644|NCT00646646|P3|Participant Flow|Placebo|Placebo Control
546645|NCT00646646|P2|Participant Flow|Midazolam|Sedative Drug 2
546646|NCT00646646|P1|Participant Flow|Dexmedetomidine|Sedative Drug 1
546647|NCT00646646|O4|Outcome|Placebo|placebo
546648|NCT00646646|O3|Outcome|Propofol|"active drug~propofol : sedative"
546649|NCT00646646|O2|Outcome|Midazolam|"Sedative~Midazolam : sedative"
546650|NCT00646646|O1|Outcome|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
546651|NCT00646646|E4|Reported Event|Propofol|"active drug~propofol : sedative"
546652|NCT00646646|E3|Reported Event|Placebo|"placebo control~saline placebo : saline placebo"
546653|NCT00646646|E2|Reported Event|Midazolam|"Sedative~Midazolam : sedative"
546654|NCT00646646|E1|Reported Event|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
546655|NCT00646581|B3|Baseline|Total|Total of all reporting groups
546656|NCT00646581|B2|Baseline|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546657|NCT00646581|B1|Baseline|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546658|NCT00646581|P2|Participant Flow|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546659|NCT00646581|P1|Participant Flow|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546660|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546661|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546662|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546663|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546664|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546665|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546666|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546667|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546668|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546669|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546670|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546671|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546672|NCT00646581|E2|Reported Event|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
546673|NCT00646581|E1|Reported Event|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
546674|NCT00646399|B3|Baseline|Total|Total of all reporting groups
546675|NCT00646399|B2|Baseline|Placebo|
546676|NCT00646399|B1|Baseline|Pagibaximab|
546677|NCT00646399|P2|Participant Flow|Placebo|
546678|NCT00646399|P1|Participant Flow|Pagibaximab|
546679|NCT00646399|O2|Outcome|Placebo|
546680|NCT00646399|O1|Outcome|Pagibaximab|
546681|NCT00646399|E2|Reported Event|Placebo|
546682|NCT00646399|E1|Reported Event|Pagibaximab|
546683|NCT00646282|B3|Baseline|Total|Total of all reporting groups
546684|NCT00646282|B2|Baseline|Control|Stable kidney transplant recipients do not receive any drug
546685|NCT00646282|B1|Baseline|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
546686|NCT00646282|P2|Participant Flow|Control|Stable kidney transplant recipients do not receive any drug.
546687|NCT00646282|P1|Participant Flow|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
546688|NCT00646282|O2|Outcome|Control|Stable kidney transplant recipients will not receive any drug
546689|NCT00646282|O1|Outcome|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
546690|NCT00646282|E2|Reported Event|Control|Stable kidney transplant recipients will not receive any drug
546813|NCT00645671|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
546691|NCT00646282|E1|Reported Event|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
546692|NCT00646048|B1|Baseline|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
546693|NCT00646048|P1|Participant Flow|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
546694|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
546695|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
546696|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
546697|NCT00646048|E1|Reported Event|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
546698|NCT00645970|B3|Baseline|Total|Total of all reporting groups
546699|NCT00645970|B2|Baseline|Registry|Participants recruited from the OEF/OIF/OND registry
546700|NCT00645970|B1|Baseline|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
546701|NCT00645970|P2|Participant Flow|Registry|Participants recruited from the OEF/OIF/OND registry
546702|NCT00645970|P1|Participant Flow|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
546703|NCT00645970|O2|Outcome|Registry|Participants recruited from the OEF/OIF/OND registry
546704|NCT00645970|O1|Outcome|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
546705|NCT00645970|E2|Reported Event|Registry|Participants recruited from the OEF/OIF/OND registry
546706|NCT00645970|E1|Reported Event|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
546707|NCT00645944|B3|Baseline|Total|Total of all reporting groups
546708|NCT00645944|B2|Baseline|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
546709|NCT00645944|B1|Baseline|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
546710|NCT00645944|P2|Participant Flow|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
546711|NCT00645944|P1|Participant Flow|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
546712|NCT00645944|O2|Outcome|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
546713|NCT00645944|O1|Outcome|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
546714|NCT00645944|E2|Reported Event|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
546715|NCT00645944|E1|Reported Event|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
546716|NCT00645853|B3|Baseline|Total|Total of all reporting groups
546717|NCT00645853|B2|Baseline|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546718|NCT00645853|B1|Baseline|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546719|NCT00645853|P2|Participant Flow|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546720|NCT00645853|P1|Participant Flow|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546721|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546768|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546722|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546723|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546724|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546725|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546726|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546727|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546728|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546729|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546730|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546731|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546732|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546733|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546734|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
546735|NCT00645853|E2|Reported Event|VKA INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
546736|NCT00645853|E1|Reported Event|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
546737|NCT00645827|B3|Baseline|Total|Total of all reporting groups
546738|NCT00645827|B2|Baseline|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546739|NCT00645827|B1|Baseline|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546740|NCT00645827|P2|Participant Flow|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546741|NCT00645827|P1|Participant Flow|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546765|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546766|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546767|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546742|NCT00645827|O2|Outcome|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546743|NCT00645827|O1|Outcome|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546744|NCT00645827|E2|Reported Event|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546745|NCT00645827|E1|Reported Event|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
546746|NCT00645788|B5|Baseline|Total|Total of all reporting groups
546747|NCT00645788|B4|Baseline|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546748|NCT00645788|B3|Baseline|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546749|NCT00645788|B2|Baseline|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546750|NCT00645788|B1|Baseline|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546751|NCT00645788|P4|Participant Flow|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546752|NCT00645788|P3|Participant Flow|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546753|NCT00645788|P2|Participant Flow|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546754|NCT00645788|P1|Participant Flow|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546755|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546756|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546757|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546758|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546759|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546760|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546761|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546762|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546763|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546764|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546812|NCT00645671|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ointment
546769|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546770|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546771|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546772|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546773|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546774|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546775|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546776|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546777|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546778|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546779|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546780|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546781|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546782|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546783|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546784|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546785|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546786|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546787|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546788|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546789|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546790|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546791|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546792|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546793|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546794|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546795|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546796|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546797|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546798|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546799|NCT00645788|E4|Reported Event|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
546800|NCT00645788|E3|Reported Event|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
546801|NCT00645788|E2|Reported Event|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546802|NCT00645788|E1|Reported Event|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
546803|NCT00645762|B1|Baseline|Balloon Dilation|
546804|NCT00645762|P1|Participant Flow|FinESS Sisnus System Balloon Dilation|Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System.
546805|NCT00645762|O1|Outcome|FinESS Balloon Arm|Subjects completing 12 month post-procedure follow-up
546806|NCT00645762|O1|Outcome|FinESS Balloon Dilation|
546807|NCT00645762|O1|Outcome|Treatment Group (ALL)|FinESS Balloon Dilation
546808|NCT00645762|E1|Reported Event|Treatment Group (ALL)|
546809|NCT00645671|B3|Baseline|Total|Total of all reporting groups
546810|NCT00645671|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ointment
546811|NCT00645671|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
546816|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
546817|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
546818|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
546819|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
546820|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
546821|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
546822|NCT00645671|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ointment
546823|NCT00645671|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
546824|NCT00645593|B3|Baseline|Total|Total of all reporting groups
546825|NCT00645593|B2|Baseline|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
546826|NCT00645593|B1|Baseline|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
546827|NCT00645593|P2|Participant Flow|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
546828|NCT00645593|P1|Participant Flow|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
546829|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
546830|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
546831|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
546832|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
546833|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
546834|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
546835|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
546836|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
546837|NCT00645593|E2|Reported Event|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
546838|NCT00645593|E1|Reported Event|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
546839|NCT00645567|B1|Baseline|Wheelchair Transfer Interventions|Persons with SCI who evaluated wheelchair transfer interventions
546840|NCT00645567|P1|Participant Flow|Wheelchair Transfer Interventions|5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.
546841|NCT00645567|O5|Outcome|Unassisted Manual Transfer|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
546842|NCT00645567|O4|Outcome|Ryno Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
546843|NCT00645567|O3|Outcome|Easy Reach Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
546844|NCT00645567|O2|Outcome|Standard Transfer Board|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
546845|NCT00645567|O1|Outcome|Glide n' Go|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
546846|NCT00645567|E1|Reported Event|Group 1|persons with SCI
546847|NCT00645528|B1|Baseline|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546848|NCT00645528|P1|Participant Flow|Insulin Education Class Participants|"Subjects attended two group visits, two weeks apart, during which they received education regarding goals of therapy, insulin use, and hypoglycemia. Self-monitored blood glucose values were reviewed and insulin was initiated, if felt appropriate by the physician investigator and if accepted by the subject. The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit.The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment.~Additionally, at the second visit, proportion of blood glucose readings below 70 mg/dl were recorded. All patients were asked how many times in the two weeks they experienced symptoms/signs of low blood sugar, how many times they required sugar intake for the these symptoms, and how many times they required another person to assist them."
546849|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546850|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546851|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546852|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546853|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546854|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546855|NCT00645528|E1|Reported Event|Arm 1|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
546856|NCT00645411|B5|Baseline|Total|Total of all reporting groups
546857|NCT00645411|B4|Baseline|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546858|NCT00645411|B3|Baseline|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546859|NCT00645411|B2|Baseline|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
546860|NCT00645411|B1|Baseline|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
546861|NCT00645411|P4|Participant Flow|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546862|NCT00645411|P3|Participant Flow|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546863|NCT00645411|P2|Participant Flow|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
546864|NCT00645411|P1|Participant Flow|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
546865|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg- derived trivalent influenza vaccine.
546866|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546867|NCT00645411|O2|Outcome|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
546868|NCT00645411|O1|Outcome|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
546869|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546870|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546871|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546872|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546873|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546874|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546875|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546876|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546877|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
546878|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
546879|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
546880|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
546881|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
546882|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
546883|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
546884|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine
546885|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546886|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546887|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg - derived trivalent influenza vaccine.
546888|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546889|NCT00645411|E6|Reported Event|Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546890|NCT00645411|E5|Reported Event|Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546891|NCT00645411|E4|Reported Event|Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
546892|NCT00645411|E3|Reported Event|Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
546893|NCT00645411|E2|Reported Event|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
546894|NCT00645411|E1|Reported Event|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
546895|NCT00645359|B1|Baseline|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
546896|NCT00645359|P1|Participant Flow|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
546897|NCT00645359|O1|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
546898|NCT00645359|O1|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
546899|NCT00645359|E1|Reported Event|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
546900|NCT00645333|B1|Baseline|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
546901|NCT00645333|P1|Participant Flow|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
546902|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
546903|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
546904|NCT00645333|E1|Reported Event|MK-0752|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
546905|NCT00645164|B1|Baseline|Xenaderm|Subject serves as own control
546906|NCT00645164|P1|Participant Flow|Xenaderm|Subject serves as own control
546907|NCT00645164|O1|Outcome|Xenaderm|Subject serves as own control
546908|NCT00645164|E1|Reported Event|Xenaderm|Subject serves as own control
546909|NCT00645099|B3|Baseline|Total|Total of all reporting groups
546910|NCT00645099|B2|Baseline|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546911|NCT00645099|B1|Baseline|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546912|NCT00645099|P2|Participant Flow|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546913|NCT00645099|P1|Participant Flow|Paliperidone Extended Release (ER)|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546914|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546915|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546916|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546917|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546918|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546919|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546920|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546921|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546922|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546923|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546924|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546925|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546926|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546927|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546928|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546929|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546930|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546931|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546932|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546933|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546934|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546935|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546936|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546937|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546938|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546939|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546940|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546941|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546942|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546943|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546944|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546945|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546946|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546947|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546948|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546949|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546950|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546951|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546952|NCT00645099|E2|Reported Event|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
546953|NCT00645099|E1|Reported Event|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
546954|NCT00645047|B3|Baseline|Total|Total of all reporting groups
546955|NCT00645047|B2|Baseline|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546956|NCT00645047|B1|Baseline|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546957|NCT00645047|P2|Participant Flow|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546958|NCT00645047|P1|Participant Flow|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546959|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546960|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546961|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546962|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546963|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546964|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546965|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546966|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546967|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546968|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546969|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546970|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546971|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546972|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546973|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546974|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546975|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546976|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546977|NCT00645047|E2|Reported Event|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
546978|NCT00645047|E1|Reported Event|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
546979|NCT00644995|B3|Baseline|Total|Total of all reporting groups
546980|NCT00644995|B2|Baseline|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity (PA)
546981|NCT00644995|B1|Baseline|Usual Care|Advice to quit smoking and referral to standard care
546982|NCT00644995|P2|Participant Flow|Step Up|proactive phone counseling addressing smoking, depression, and PA
546983|NCT00644995|P1|Participant Flow|Usual Care|Advice to quit and referral to standard care
546984|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
546985|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
546986|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
546987|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
546988|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
546989|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
546990|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
546991|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
546992|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
546993|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
546994|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and PA
546995|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
546996|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and physical activity
546997|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
546998|NCT00644995|E2|Reported Event|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity
546999|NCT00644995|E1|Reported Event|Usual Care|Advice to quit and referral to standard care
547000|NCT00644969|B3|Baseline|Total|Total of all reporting groups
547001|NCT00644969|B2|Baseline|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547002|NCT00644969|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547003|NCT00644969|P2|Participant Flow|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547004|NCT00644969|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547005|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547006|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547007|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547008|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547009|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547010|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547011|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547012|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547013|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547014|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547015|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547016|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547017|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547018|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547019|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547020|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547021|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547022|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547023|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547024|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547025|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547026|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547027|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547028|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547029|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547030|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547031|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547032|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547033|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547034|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547035|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547036|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547037|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547038|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547039|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547040|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547041|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547042|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547043|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547044|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547045|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547046|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547047|NCT00644969|E2|Reported Event|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
547048|NCT00644969|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
547049|NCT00644917|B1|Baseline|Xenaderm vs. Vehicle - Subjects Acted as Own Comparator|Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs
547050|NCT00644917|P1|Participant Flow|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
547051|NCT00644917|O5|Outcome|Xenaderm Vehicle - Non-irradiated|20 mg samples of Xenaderm Vehicle applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
549239|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
547052|NCT00644917|O4|Outcome|Xenaderm Ointment - Non-irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
547053|NCT00644917|O3|Outcome|Control - Irradiated|test site was covered with an empty Finn Chamber as a control site - then irradiated
547054|NCT00644917|O2|Outcome|Xenaderm Vehicle - Irradiated|20 mg sample of Vehicle applied in Finn Chamber to test site on the left side of each subject's back - then irradiated
547055|NCT00644917|O1|Outcome|Xenaderm Ointment - Irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - then irradiated
547056|NCT00644917|E1|Reported Event|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
547057|NCT00644787|B1|Baseline|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547058|NCT00644787|P3|Participant Flow|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547059|NCT00644787|P2|Participant Flow|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547060|NCT00644787|P1|Participant Flow|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547061|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547062|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547063|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547064|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547065|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547066|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547067|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547068|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547261|NCT00643916|P2|Participant Flow|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
547069|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547070|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547071|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547072|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547073|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547074|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547075|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547076|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547077|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547078|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547079|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547080|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547081|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547082|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547162|NCT00644059|B3|Baseline|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547262|NCT00643916|P1|Participant Flow|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
547083|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547084|NCT00644787|E3|Reported Event|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547085|NCT00644787|E2|Reported Event|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
547086|NCT00644787|E1|Reported Event|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
547087|NCT00644657|B1|Baseline|Clopidogrel|All 27 subjects received a 300 mg loading dose of clopidogrel
547088|NCT00644657|P1|Participant Flow|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
547089|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
547090|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
547091|NCT00644657|E1|Reported Event|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
547092|NCT00644592|B3|Baseline|Total|Total of all reporting groups
547093|NCT00644592|B2|Baseline|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
547094|NCT00644592|B1|Baseline|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
547095|NCT00644592|P2|Participant Flow|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
547096|NCT00644592|P1|Participant Flow|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
547097|NCT00644592|O2|Outcome|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
547098|NCT00644592|O1|Outcome|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
547099|NCT00644592|E2|Reported Event|2 Placebo|4 weeks of placebo.
547100|NCT00644592|E1|Reported Event|1-Fenofibrate|4 weeks of drug at 160 mg orally per day
547101|NCT00644358|B1|Baseline|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
547102|NCT00644358|P1|Participant Flow|Vilazodone|Vilazodone titrated up to 40 milligrams (mg)/day for 1 year.
547103|NCT00644358|O1|Outcome|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
547104|NCT00644358|O1|Outcome|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
547105|NCT00644358|O1|Outcome|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
547106|NCT00644358|O1|Outcome|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
547107|NCT00644358|E1|Reported Event|Vilazodone|Vilazodone titrated up to 40 mg/day for 1 year.
547108|NCT00644332|B1|Baseline|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547109|NCT00644332|P1|Participant Flow|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547110|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547111|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547112|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547193|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547113|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547114|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547115|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547116|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547117|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547118|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547119|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547120|NCT00644332|E1|Reported Event|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
547121|NCT00644280|B3|Baseline|Total|Total of all reporting groups
547122|NCT00644280|B2|Baseline|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
547123|NCT00644280|B1|Baseline|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
547124|NCT00644280|P2|Participant Flow|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
547125|NCT00644280|P1|Participant Flow|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
547126|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
547127|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
547128|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
547129|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
547130|NCT00644280|E2|Reported Event|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
547131|NCT00644280|E1|Reported Event|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
547132|NCT00644228|B3|Baseline|Total|Total of all reporting groups
547133|NCT00644228|B2|Baseline|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547134|NCT00644228|B1|Baseline|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547135|NCT00644228|P2|Participant Flow|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547136|NCT00644228|P1|Participant Flow|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547137|NCT00644228|O2|Outcome|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547138|NCT00644228|O1|Outcome|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547139|NCT00644228|O2|Outcome|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547140|NCT00644228|O1|Outcome|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547141|NCT00644228|O2|Outcome|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547142|NCT00644228|O1|Outcome|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547143|NCT00644228|E2|Reported Event|Arm II (Dexamethasone, Lenalidomide, Bortezomib)|"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547144|NCT00644228|E1|Reported Event|Arm I (Dexamethasone and Lenalidomide)|"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~Dexamethasone: Given PO~Laboratory Biomarker Analysis: Optional correlative studies~Lenalidomide: Given PO"
547145|NCT00644189|B1|Baseline|Clofarabine Phase I|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
547146|NCT00644189|P4|Participant Flow|Clofarabine: 3 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547147|NCT00644189|P3|Participant Flow|Clofarabine 4 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547148|NCT00644189|P2|Participant Flow|Clofarabine 2 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547149|NCT00644189|P1|Participant Flow|Clofarabine 1 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547150|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547151|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547152|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547153|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547154|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
547155|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
547156|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
547157|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
547158|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547159|NCT00644189|O1|Outcome|Phase I-II|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
547160|NCT00644189|E1|Reported Event|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
547161|NCT00644059|B4|Baseline|Total|Total of all reporting groups
547194|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
547163|NCT00644059|B2|Baseline|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547164|NCT00644059|B1|Baseline|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547165|NCT00644059|P3|Participant Flow|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine
547166|NCT00644059|P2|Participant Flow|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547167|NCT00644059|P1|Participant Flow|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547168|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of
547169|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547170|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547171|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547172|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547173|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547174|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
547175|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547176|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547177|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547178|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547179|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547180|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547181|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547182|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547183|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547184|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547185|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547186|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547187|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547188|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547189|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547190|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547191|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
547192|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
549281|NCT00639379|O1|Outcome|Senofilcon A Toric|
547195|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547196|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547197|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547198|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547199|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547200|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547201|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547202|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547203|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547204|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547205|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547206|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547207|NCT00644059|O6|Outcome|Flu Control (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547208|NCT00644059|O5|Outcome|Non-flu Control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547209|NCT00644059|O4|Outcome|TIV-adj (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547210|NCT00644059|O3|Outcome|Flu-control (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547211|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547212|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
547213|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547214|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547215|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547216|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547217|NCT00644059|O5|Outcome|Non-flu Control (36 to < 72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547218|NCT00644059|O4|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547219|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547220|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547221|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547222|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547223|NCT00644059|O5|Outcome|Non-flu Control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547224|NCT00644059|O4|Outcome|TIV-adj (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547260|NCT00643916|P3|Participant Flow|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
547225|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547226|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547227|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547228|NCT00644059|O6|Outcome|Non-Flu-control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547229|NCT00644059|O5|Outcome|Flu-control (6 to <72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547230|NCT00644059|O4|Outcome|TIV-adj (6 to <72 Months )|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547231|NCT00644059|O3|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547232|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547233|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547234|NCT00644059|O6|Outcome|Non-Flu-control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547235|NCT00644059|O5|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547236|NCT00644059|O4|Outcome|Flu-control (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547237|NCT00644059|O3|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547238|NCT00644059|O2|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547239|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547240|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547241|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547242|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547243|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
547244|NCT00644059|E6|Reported Event|Non-Flu-control (TBE Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547245|NCT00644059|E5|Reported Event|Non-Flu-control (TBE/Men C Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
547246|NCT00644059|E4|Reported Event|Flu-control_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547247|NCT00644059|E3|Reported Event|Flu-control_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
547248|NCT00644059|E2|Reported Event|TIV-adj_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547249|NCT00644059|E1|Reported Event|TIV-adj_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
547250|NCT00643916|B7|Baseline|Total|Total of all reporting groups
547251|NCT00643916|B6|Baseline|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
547252|NCT00643916|B5|Baseline|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
547253|NCT00643916|B4|Baseline|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
547254|NCT00643916|B3|Baseline|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
547255|NCT00643916|B2|Baseline|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
547256|NCT00643916|B1|Baseline|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
547257|NCT00643916|P6|Participant Flow|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
547258|NCT00643916|P5|Participant Flow|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
547259|NCT00643916|P4|Participant Flow|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
547263|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
547264|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
547265|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
547266|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
547267|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
547268|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
547269|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
547270|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
547271|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
547272|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
547273|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
547274|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
547275|NCT00643916|E6|Reported Event|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
547276|NCT00643916|E5|Reported Event|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
547277|NCT00643916|E4|Reported Event|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
547278|NCT00643916|E3|Reported Event|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
547279|NCT00643916|E2|Reported Event|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
547280|NCT00643916|E1|Reported Event|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
547281|NCT00643851|B4|Baseline|Total|Total of all reporting groups
547282|NCT00643851|B3|Baseline|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547283|NCT00643851|B2|Baseline|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547284|NCT00643851|B1|Baseline|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547285|NCT00643851|P3|Participant Flow|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547286|NCT00643851|P2|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547287|NCT00643851|P1|Participant Flow|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547288|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547289|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547290|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547291|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547292|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547293|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547294|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547295|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547296|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547297|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547298|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547299|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547300|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547301|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547302|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547303|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547304|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547305|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547306|NCT00643851|E3|Reported Event|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
547307|NCT00643851|E2|Reported Event|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
547308|NCT00643851|E1|Reported Event|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
547309|NCT00643760|B6|Baseline|Total|Total of all reporting groups
547310|NCT00643760|B5|Baseline|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547311|NCT00643760|B4|Baseline|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
549282|NCT00639379|O2|Outcome|Alphafilcon A Toric|
547312|NCT00643760|B3|Baseline|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547313|NCT00643760|B2|Baseline|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547314|NCT00643760|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547315|NCT00643760|P5|Participant Flow|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547316|NCT00643760|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547317|NCT00643760|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547318|NCT00643760|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547319|NCT00643760|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547320|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547321|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547322|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547323|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547324|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547325|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547326|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547327|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547328|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547329|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547330|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547331|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547332|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547333|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547334|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547335|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547336|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547337|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547338|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547339|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
549283|NCT00639379|O1|Outcome|Senofilcon A Toric|
547340|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547341|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547342|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547343|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547344|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547345|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547346|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547347|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547348|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547349|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547350|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547351|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547352|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547353|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547354|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547355|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547356|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547357|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547358|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547359|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547360|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547361|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547362|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547363|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547364|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547365|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547366|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547367|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547396|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547368|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547369|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547370|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547371|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547372|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547373|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547374|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547375|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547376|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547377|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547378|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547379|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547380|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547381|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547382|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547383|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547384|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547385|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547386|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547387|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547388|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547389|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547390|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547391|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547392|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547393|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547394|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547395|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547429|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
547397|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547398|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547399|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547400|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547401|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547402|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547403|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547404|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547405|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547406|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547407|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547408|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547409|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547410|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547411|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547412|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547413|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547414|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547415|NCT00643760|E5|Reported Event|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
547416|NCT00643760|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547417|NCT00643760|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547418|NCT00643760|E2|Reported Event|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
547419|NCT00643760|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
547420|NCT00643682|B3|Baseline|Total|Total of all reporting groups
547421|NCT00643682|B2|Baseline|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
547422|NCT00643682|B1|Baseline|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
547423|NCT00643682|P2|Participant Flow|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
547424|NCT00643682|P1|Participant Flow|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
547425|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
547426|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
547427|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
547428|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
549284|NCT00639379|O2|Outcome|Alphafilcon A Toric|
547430|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
547431|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
547432|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
547433|NCT00643682|E2|Reported Event|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
547434|NCT00643682|E1|Reported Event|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
547435|NCT00643604|B1|Baseline|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547436|NCT00643604|P1|Participant Flow|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547437|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547438|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547439|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547440|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547441|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547442|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547443|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547444|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547445|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547446|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547447|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547448|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547449|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547450|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547451|NCT00643604|E1|Reported Event|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
547452|NCT00643578|B1|Baseline|All Participants|A single dose of 12 mcg and 24 mcg, on separate days, of formoterol were given.
547453|NCT00643578|P2|Participant Flow|Formoterol 24 First|a single dose of 24 mcg of formoterol was given first, then 12 mcg of formoterol
547454|NCT00643578|P1|Participant Flow|Formoterol 12 First|a single dose of 12 mcg of formoterol was given first, then 24 mcg of formoterol
547455|NCT00643578|O2|Outcome|24 Mcg of Formoterol|high dose
547456|NCT00643578|O1|Outcome|12 Mcg of Formoterol|low dose
547457|NCT00643578|O2|Outcome|24 Mcg Formoterol|high dose
547458|NCT00643578|O1|Outcome|12 Mcg Formoterol|low dose
547459|NCT00643578|E2|Reported Event|Formoterol 24|A single dose of 24 mcg of formoterol was administered.
547460|NCT00643578|E1|Reported Event|Formoterol 12|A single dose of 12 mcg of formoterol was administered.
547461|NCT00643565|B3|Baseline|Total|Total of all reporting groups
547462|NCT00643565|B2|Baseline|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547463|NCT00643565|B1|Baseline|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547503|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
547504|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547464|NCT00643565|P2|Participant Flow|Bevacizumab + Chemotherapy|Participants received continuous intravenous (IV) infusion of bevacizumab (7.5 milligrams per kilogram [mg/kg] every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547465|NCT00643565|P1|Participant Flow|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy i.e. with ifosfamide [I], vincristine [V], actinomycin D [A] and doxorubicin [Do] followed by 5 cycles of IVA-containing chemotherapy [i.e. without doxorubicin]) administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547466|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547467|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547468|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547469|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547470|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547471|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547481|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
549285|NCT00639379|O1|Outcome|Senofilcon A Toric|
547472|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547473|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547474|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547475|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547476|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547477|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547478|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547479|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547480|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547500|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
547501|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547502|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547482|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547483|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547484|NCT00643565|E2|Reported Event|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
547485|NCT00643565|E1|Reported Event|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
547486|NCT00643487|B1|Baseline|All Participants|No new arms or groups were associated with this observational study
547487|NCT00643487|P1|Participant Flow|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
547488|NCT00643487|O1|Outcome|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
547489|NCT00643487|E1|Reported Event|All Participants|observation of the behavior of the infrapatellar plica: Local anesthesia using bupivicaine will be initiated. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises. Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
547490|NCT00643448|B4|Baseline|Total|Total of all reporting groups
547491|NCT00643448|B3|Baseline|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
547492|NCT00643448|B2|Baseline|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547493|NCT00643448|B1|Baseline|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547494|NCT00643448|P3|Participant Flow|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
547495|NCT00643448|P2|Participant Flow|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547496|NCT00643448|P1|Participant Flow|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547497|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
547498|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547499|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547505|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
547506|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547507|NCT00643448|E3|Reported Event|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
547508|NCT00643448|E2|Reported Event|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547509|NCT00643448|E1|Reported Event|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
547510|NCT00643201|B3|Baseline|Total|Total of all reporting groups
547511|NCT00643201|B2|Baseline|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547512|NCT00643201|B1|Baseline|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham International normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547513|NCT00643201|P2|Participant Flow|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~Warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547514|NCT00643201|P1|Participant Flow|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham international normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547515|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547516|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547517|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547518|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547519|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547520|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547521|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547522|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547523|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547524|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547525|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547526|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547527|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547591|NCT00643006|B2|Baseline|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
547528|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547529|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547530|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547531|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547532|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547533|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547534|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547535|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547536|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547537|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547538|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547539|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547540|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547541|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547542|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547543|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547544|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547545|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547546|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547547|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547548|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547592|NCT00643006|B1|Baseline|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
547549|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547550|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547551|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547552|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547553|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547554|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547555|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547556|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547557|NCT00643201|E2|Reported Event|Enoxaparin/Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
547558|NCT00643201|E1|Reported Event|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
547559|NCT00643123|B3|Baseline|Total|Total of all reporting groups
547560|NCT00643123|B2|Baseline|Placebo|Placebo: Inactive substance
547561|NCT00643123|B1|Baseline|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
547562|NCT00643123|P2|Participant Flow|Placebo|Placebo: Inactive substance
547563|NCT00643123|P1|Participant Flow|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
547564|NCT00643123|O2|Outcome|Placebo|Placebo: Inactive substance
547565|NCT00643123|O1|Outcome|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
547566|NCT00643123|E2|Reported Event|Allopurinol|Allopurinol: 300-600 mg/day over a 6 week period
547567|NCT00643123|E1|Reported Event|Placebo|Placebo: Inactive substance
547568|NCT00643097|B4|Baseline|Total|Total of all reporting groups
547569|NCT00643097|B3|Baseline|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
547570|NCT00643097|B2|Baseline|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
547571|NCT00643097|B1|Baseline|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
547572|NCT00643097|P3|Participant Flow|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
547573|NCT00643097|P2|Participant Flow|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
547574|NCT00643097|P1|Participant Flow|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
547575|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
547576|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
547577|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
547578|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
547579|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
547580|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
547581|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
547582|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
547583|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
547584|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
547585|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
547586|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
547587|NCT00643097|E3|Reported Event|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
547588|NCT00643097|E2|Reported Event|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
547589|NCT00643097|E1|Reported Event|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
547590|NCT00643006|B3|Baseline|Total|Total of all reporting groups
547593|NCT00643006|P2|Participant Flow|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
547594|NCT00643006|P1|Participant Flow|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
547595|NCT00643006|O2|Outcome|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
547596|NCT00643006|O1|Outcome|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
547597|NCT00643006|O2|Outcome|Arm B. Active Comparator|The active comparison group participated in low-intensive walks.
547598|NCT00643006|O1|Outcome|Arm A. Exercise|The intervention group participated in Nordic walking
547599|NCT00643006|E2|Reported Event|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
547600|NCT00643006|E1|Reported Event|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
547601|NCT00642993|B3|Baseline|Total|Total of all reporting groups
547602|NCT00642993|B2|Baseline|Placebo|Placebo capsules, administered orally, once daily
547603|NCT00642993|B1|Baseline|SCH 497079|SCH 497079, administered orally, once daily
547604|NCT00642993|P2|Participant Flow|Placebo|Placebo capsules, administered orally, once daily
547605|NCT00642993|P1|Participant Flow|SCH 497079|SCH 497079, administered orally, once daily
547606|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
547607|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
547608|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
547609|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
547610|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
547611|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
547612|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
547613|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
547614|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
547615|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
547616|NCT00642993|E2|Reported Event|Placebo|Placebo capsules, administered orally, once daily
547617|NCT00642993|E1|Reported Event|SCH 497079|SCH 497079, administered orally, once daily
547618|NCT00642902|B5|Baseline|Total|Total of all reporting groups
547619|NCT00642902|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
547620|NCT00642902|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
547621|NCT00642902|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
547622|NCT00642902|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
547623|NCT00642902|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
547624|NCT00642902|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
547625|NCT00642902|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
547626|NCT00642902|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
547627|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
547628|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
547629|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
547630|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
547631|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
547632|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
547633|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
547634|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
547635|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
547636|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
547637|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
547638|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
547639|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
547640|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
547641|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
547642|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
547643|NCT00642902|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
547644|NCT00642902|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
547645|NCT00642902|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
547646|NCT00642902|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
547647|NCT00642850|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547648|NCT00642850|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
547649|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547650|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547651|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547652|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547653|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547654|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547655|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547656|NCT00642850|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
547657|NCT00642811|B7|Baseline|Total|Total of all reporting groups
547658|NCT00642811|B6|Baseline|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547659|NCT00642811|B5|Baseline|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547660|NCT00642811|B4|Baseline|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547661|NCT00642811|B3|Baseline|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547662|NCT00642811|B2|Baseline|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547663|NCT00642811|B1|Baseline|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547664|NCT00642811|P6|Participant Flow|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; stay on ticagrelor 90 mg twice daily (bd) for 2 weeks.
547665|NCT00642811|P5|Participant Flow|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
548057|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
547666|NCT00642811|P4|Participant Flow|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
547667|NCT00642811|P3|Participant Flow|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; stay on clopidogrel 75 mg once daily (od) for 2 weeks
547668|NCT00642811|P2|Participant Flow|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
547669|NCT00642811|P1|Participant Flow|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
547670|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547671|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547672|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547673|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547674|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547675|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547676|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547677|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547678|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547679|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547680|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547681|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
547682|NCT00642811|E8|Reported Event|Clop. Responders/Switching Period: Clopidogrel-Ticagrelor|included responders exposed to clopidogrel switching to ticagrelor on Day 15.
547683|NCT00642811|E7|Reported Event|Clop. Responders/Switching Period: Ticagrelor-Clopidogrel|included responders exposed to ticagrelor switching to clopidogrel on Day 15.
547684|NCT00642811|E6|Reported Event|Clop. Responders/Non-Switching Period: Clopidogrel|included responders exposed to clopidogrel on Day 1-14, Day 16-28.
547685|NCT00642811|E5|Reported Event|Clop. Responders/Non-Switching Period: Ticagrelor|included responders exposed to ticagrelor on Day 1-14, Day 16-28.
547686|NCT00642811|E4|Reported Event|Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor|included non-responders exposed to clopidogrel switching to ticagrelor on Day 15.
547687|NCT00642811|E3|Reported Event|Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel|included non-responders exposed to ticagrelor switching to clopidogrel on Day 15.
547688|NCT00642811|E2|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel|included non-responders exposed to clopidogrel on Day 1-14, Day 16-28.
547689|NCT00642811|E1|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor|included non-responders exposed to ticagrelor on Day 1-14, Day 16-28.
547690|NCT00642772|B1|Baseline|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
547691|NCT00642772|P1|Participant Flow|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
547692|NCT00642772|O1|Outcome|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
547693|NCT00642772|E1|Reported Event|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
547694|NCT00642759|B1|Baseline|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
547695|NCT00642759|P1|Participant Flow|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
547696|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab~carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab: IV infusion"
547697|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab~carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab: IV infusion"
547698|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab~carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab: IV infusion"
547699|NCT00642759|O1|Outcome|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
547700|NCT00642759|E1|Reported Event|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
547701|NCT00642746|B3|Baseline|Total|Total of all reporting groups
547702|NCT00642746|B2|Baseline|FOLFOX With Erlotinib|
547703|NCT00642746|B1|Baseline|FOLFIRI With Erlotinib|
547704|NCT00642746|P2|Participant Flow|FOLFOX With Erlotinib|
547705|NCT00642746|P1|Participant Flow|FOLFIRI With Erlotinib|
547706|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
547707|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
547708|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
547709|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
547710|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
547711|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
547712|NCT00642746|E2|Reported Event|FOLFOX With Erlotinib|
547713|NCT00642746|E1|Reported Event|FOLFIRI With Erlotinib|
547714|NCT00642707|B5|Baseline|Total|Total of all reporting groups
547715|NCT00642707|B4|Baseline|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
547716|NCT00642707|B3|Baseline|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
547717|NCT00642707|B2|Baseline|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
547718|NCT00642707|B1|Baseline|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
547719|NCT00642707|P4|Participant Flow|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
547720|NCT00642707|P3|Participant Flow|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
547721|NCT00642707|P2|Participant Flow|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
547722|NCT00642707|P1|Participant Flow|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
547723|NCT00642707|O4|Outcome|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
547724|NCT00642707|O3|Outcome|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
547725|NCT00642707|O2|Outcome|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
547726|NCT00642707|O1|Outcome|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
547727|NCT00642707|E4|Reported Event|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
547728|NCT00642707|E3|Reported Event|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
547729|NCT00642707|E2|Reported Event|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
547730|NCT00642707|E1|Reported Event|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
547731|NCT00642694|B3|Baseline|Total|Total of all reporting groups
547732|NCT00642694|B2|Baseline|Escitalopram + Placebo|Placebo augmentation
547733|NCT00642694|B1|Baseline|Escitalopram + Ramelteon|active augmentation
547734|NCT00642694|P2|Participant Flow|Escitalopram + Placebo|Placebo augmentation
547735|NCT00642694|P1|Participant Flow|Escitalopram + Ramelteon|active augmentation
547736|NCT00642694|O2|Outcome|Escitalopram + Placebo|control group
547737|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
547738|NCT00642694|O2|Outcome|Escitalopram + Placebp|control group
547739|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
547740|NCT00642694|E2|Reported Event|Escitalopram + Placebo|Placebo augmentation
547741|NCT00642694|E1|Reported Event|Escitalopram + Ramelteon|active augmentation
547742|NCT00642668|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
547743|NCT00642668|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
549286|NCT00639379|O2|Outcome|Alphafilcon A Toric|
547744|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
547745|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
547746|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
547747|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
547748|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
547749|NCT00642668|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
547750|NCT00642642|B1|Baseline|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
547751|NCT00642642|P1|Participant Flow|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
547752|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks randomized to receive placebo treatment
547753|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
547754|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
547755|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
547756|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
547757|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks treated with autologous fibroblasts
547758|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
547759|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
547760|NCT00642642|E3|Reported Event|Non-treatment Area Adverse Events|Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
547761|NCT00642642|E2|Reported Event|Placebo Cheeks|Cheeks randomized to receive placebo treatment
547762|NCT00642642|E1|Reported Event|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
547763|NCT00642616|B5|Baseline|Total|Total of all reporting groups
547764|NCT00642616|B4|Baseline|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD.
547765|NCT00642616|B3|Baseline|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with COPD
547766|NCT00642616|B2|Baseline|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
547767|NCT00642616|B1|Baseline|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with Asthma
547768|NCT00642616|P4|Participant Flow|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
547769|NCT00642616|P3|Participant Flow|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
547770|NCT00642616|P2|Participant Flow|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
547771|NCT00642616|P1|Participant Flow|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
547772|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
547773|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
547774|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
547775|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
547776|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
547777|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
547778|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
547779|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
547780|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
547781|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
547782|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
547783|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
547784|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
547785|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
547786|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
547787|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
547788|NCT00642616|E4|Reported Event|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
547789|NCT00642616|E3|Reported Event|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
547790|NCT00642616|E2|Reported Event|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
547791|NCT00642616|E1|Reported Event|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
547792|NCT00642603|B3|Baseline|Total|Total of all reporting groups
547793|NCT00642603|B2|Baseline|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547794|NCT00642603|B1|Baseline|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547795|NCT00642603|P2|Participant Flow|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547796|NCT00642603|P1|Participant Flow|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547797|NCT00642603|O2|Outcome|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547798|NCT00642603|O1|Outcome|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547799|NCT00642603|E2|Reported Event|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547800|NCT00642603|E1|Reported Event|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
547801|NCT00642473|B3|Baseline|Total|Total of all reporting groups
547802|NCT00642473|B2|Baseline|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
547803|NCT00642473|B1|Baseline|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
547804|NCT00642473|P2|Participant Flow|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
547805|NCT00642473|P1|Participant Flow|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 milligrams (mg) orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
547806|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
547807|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
547808|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
547809|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash.
547810|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
547811|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
547812|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
547813|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash .
547814|NCT00642473|E2|Reported Event|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
547815|NCT00642473|E1|Reported Event|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
547816|NCT00642460|B3|Baseline|Total|Total of all reporting groups
547817|NCT00642460|B2|Baseline|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547818|NCT00642460|B1|Baseline|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
547819|NCT00642460|P6|Participant Flow|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547820|NCT00642460|P5|Participant Flow|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547821|NCT00642460|P4|Participant Flow|Tocilizumab Switchers|"Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
547822|NCT00642460|P3|Participant Flow|Placebo|Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
547823|NCT00642460|P2|Participant Flow|Tocilizumab_12 mg/kg|"Tocilizumab 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547824|NCT00642460|P1|Participant Flow|Tocilizumab_8 mg/kg|"Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
547825|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547826|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547827|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
549287|NCT00639379|O1|Outcome|Senofilcon A Toric|
547828|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547829|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547830|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547831|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547832|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547833|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547834|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547835|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547836|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547837|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547838|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547839|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547840|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547841|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547842|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547843|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547844|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547845|NCT00642460|O1|Outcome|All Participants Treated With Tocilizumab|"Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547846|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547847|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547848|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547849|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
549288|NCT00639379|O2|Outcome|Alphafilcon A Toric|
547850|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547851|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547852|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547853|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547854|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547855|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547856|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547857|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547858|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547859|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547860|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547861|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547862|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547863|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547864|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547865|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547866|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547867|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547868|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547869|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547870|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547871|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547872|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547873|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547874|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547875|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547876|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547877|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547878|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547879|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547880|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547881|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547882|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547883|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547884|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547885|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
547886|NCT00642460|E1|Reported Event|All Tocilizumab (Part I, Part II and Part III)|Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
547887|NCT00642382|B3|Baseline|Total|Total of all reporting groups
547888|NCT00642382|B2|Baseline|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547889|NCT00642382|B1|Baseline|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547890|NCT00642382|P2|Participant Flow|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547891|NCT00642382|P1|Participant Flow|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547892|NCT00642382|O2|Outcome|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547893|NCT00642382|O1|Outcome|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547894|NCT00642382|E2|Reported Event|Control|"Normal Saline~Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547895|NCT00642382|E1|Reported Event|Active|"Agilus (Hyaluronic Acid)~Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks."
547896|NCT00642369|B3|Baseline|Total|Total of all reporting groups
547897|NCT00642369|B2|Baseline|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
547898|NCT00642369|B1|Baseline|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
547899|NCT00642369|P2|Participant Flow|Haloperidol|slow wave sleep% in haloperidol treatment group
547900|NCT00642369|P1|Participant Flow|Quetiapine Fumarate|slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group
547901|NCT00642369|O2|Outcome|Haloperidol|percentage of rapid eye movement sleep in haloperidol group
547902|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of rapid eye movement sleep in quetiapine fumarate group
547903|NCT00642369|O2|Outcome|Haloperidol|percentage of slow wave sleep in haloperidol group
547904|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of slow wave sleep in quetiapine fumarate group
547905|NCT00642369|E2|Reported Event|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
547906|NCT00642369|E1|Reported Event|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
547907|NCT00642356|B3|Baseline|Total|Total of all reporting groups
547908|NCT00642356|B2|Baseline|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
547909|NCT00642356|B1|Baseline|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
547910|NCT00642356|P2|Participant Flow|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
548058|NCT00641719|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
547911|NCT00642356|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
547912|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
547913|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
547914|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
547915|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
547916|NCT00642356|E2|Reported Event|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
547917|NCT00642356|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
547918|NCT00642304|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547919|NCT00642304|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.
547920|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547921|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547922|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547923|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547924|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547925|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547926|NCT00642304|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
547927|NCT00642278|B8|Baseline|Total|Total of all reporting groups
547928|NCT00642278|B7|Baseline|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547929|NCT00642278|B6|Baseline|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547930|NCT00642278|B5|Baseline|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547931|NCT00642278|B4|Baseline|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547932|NCT00642278|B3|Baseline|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547933|NCT00642278|B2|Baseline|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547934|NCT00642278|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547935|NCT00642278|P7|Participant Flow|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547936|NCT00642278|P6|Participant Flow|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547937|NCT00642278|P5|Participant Flow|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547938|NCT00642278|P4|Participant Flow|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547939|NCT00642278|P3|Participant Flow|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547940|NCT00642278|P2|Participant Flow|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547941|NCT00642278|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547942|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547943|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547944|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547945|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547946|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547947|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547948|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547949|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547950|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547951|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547952|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547953|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547954|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547955|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547956|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547957|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547958|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547959|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547960|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547961|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547962|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547963|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547964|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547965|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547966|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547967|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547968|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547969|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547970|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547971|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
548059|NCT00641719|E1|Reported Event|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
547972|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547973|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547974|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547975|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547976|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547977|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547978|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547979|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547980|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547981|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547982|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547983|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547984|NCT00642278|E7|Reported Event|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547985|NCT00642278|E6|Reported Event|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
547986|NCT00642278|E5|Reported Event|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547987|NCT00642278|E4|Reported Event|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547988|NCT00642278|E3|Reported Event|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547989|NCT00642278|E2|Reported Event|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
547990|NCT00642278|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 12 weeks.
547991|NCT00642174|B3|Baseline|Total|Total of all reporting groups
547992|NCT00642174|B2|Baseline|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
547993|NCT00642174|B1|Baseline|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
547994|NCT00642174|P2|Participant Flow|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
547995|NCT00642174|P1|Participant Flow|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
547996|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
547997|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
547998|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
547999|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
548000|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
548001|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
548002|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
548003|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
548004|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
548005|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
548006|NCT00642174|E2|Reported Event|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
548007|NCT00642174|E1|Reported Event|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
548008|NCT00641862|B3|Baseline|Total|Total of all reporting groups
548060|NCT00641706|B3|Baseline|Total|Total of all reporting groups
548009|NCT00641862|B2|Baseline|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
548010|NCT00641862|B1|Baseline|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
548011|NCT00641862|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
548012|NCT00641862|P1|Participant Flow|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
548013|NCT00641862|O2|Outcome|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
548014|NCT00641862|O1|Outcome|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
548015|NCT00641862|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
548016|NCT00641862|E1|Reported Event|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
548017|NCT00641797|B3|Baseline|Total|Total of all reporting groups
548018|NCT00641797|B2|Baseline|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
548019|NCT00641797|B1|Baseline|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
548020|NCT00641797|P2|Participant Flow|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
548021|NCT00641797|P1|Participant Flow|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
548022|NCT00641797|O2|Outcome|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
548023|NCT00641797|O1|Outcome|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
548024|NCT00641797|E2|Reported Event|Arm 2, Epley Maneuver|"Patients will receive vestibular rehabilitation (the Epley Maneuver).~Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver."
548025|NCT00641797|E1|Reported Event|Arm 1, Conventional Therapy|"Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).~Meclizine: medication administration 25mg PO one time~Lorazepam: Lorazepam 1 - 5mg PO/IV prn~Diphenhydramine: 25 - 50mg PO/IV once prn~Ondansetron: Ondansetron 4 - 8 mg PO/IV prn"
548026|NCT00641745|B3|Baseline|Total|Total of all reporting groups
548027|NCT00641745|B2|Baseline|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
548028|NCT00641745|B1|Baseline|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
548029|NCT00641745|P2|Participant Flow|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
548030|NCT00641745|P1|Participant Flow|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
548031|NCT00641745|O2|Outcome|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
548032|NCT00641745|O1|Outcome|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
548033|NCT00641745|E2|Reported Event|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
548034|NCT00641745|E1|Reported Event|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
548035|NCT00641719|B3|Baseline|Total|Total of all reporting groups
548036|NCT00641719|B2|Baseline|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548037|NCT00641719|B1|Baseline|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548038|NCT00641719|P2|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548039|NCT00641719|P1|Participant Flow|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548040|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548041|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548042|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548043|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548044|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548045|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548046|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548047|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548048|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548049|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548050|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548051|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548052|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548053|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548054|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
548055|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
548056|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
549289|NCT00639379|O1|Outcome|Senofilcon A Toric|
548061|NCT00641706|B2|Baseline|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
548062|NCT00641706|B1|Baseline|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
548063|NCT00641706|P2|Participant Flow|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
548064|NCT00641706|P1|Participant Flow|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
548065|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
548066|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
548067|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
548068|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
548069|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
548070|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
548071|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
548072|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
548073|NCT00641706|E2|Reported Event|Arm B (Undergoing Surgery)|vorinostat : Given orally
548074|NCT00641706|E1|Reported Event|Arm A (Not Undergoing Surgery)|vorinostat : Given orally
548075|NCT00641667|B1|Baseline|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548076|NCT00641667|P1|Participant Flow|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548077|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548078|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548104|NCT00641537|P8|Participant Flow|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
548079|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548080|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548081|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548082|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548083|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548084|NCT00641667|E1|Reported Event|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
548085|NCT00641641|B1|Baseline|Drug Intervention|Tenofovir+emtricitabine+raltegravir
548086|NCT00641641|P1|Participant Flow|Drug Intervention|Tenofovir+emtricitabine+raltegravir
548087|NCT00641641|O1|Outcome|Drug Intervention|Tenofovir+emtricitabine+raltegravir
548088|NCT00641641|E1|Reported Event|Drug Intervention|Tenofovir+emtricitabine+raltegravir
548089|NCT00641563|B1|Baseline|All Study Participants|Both arms combined
548090|NCT00641563|P2|Participant Flow|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
548091|NCT00641563|P1|Participant Flow|Dex/Remi Followed by Mida/Remi|Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week
548092|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
548093|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
548094|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
548095|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
548096|NCT00641563|E2|Reported Event|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
548097|NCT00641563|E1|Reported Event|Dex/Remi|Sedation with dexmedetomidine and remifentanil
548098|NCT00641537|B6|Baseline|Total|Total of all reporting groups
548099|NCT00641537|B5|Baseline|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548100|NCT00641537|B4|Baseline|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548101|NCT00641537|B3|Baseline|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548102|NCT00641537|B2|Baseline|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548103|NCT00641537|B1|Baseline|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548183|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548105|NCT00641537|P7|Participant Flow|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
548106|NCT00641537|P6|Participant Flow|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
548107|NCT00641537|P5|Participant Flow|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548108|NCT00641537|P4|Participant Flow|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548109|NCT00641537|P3|Participant Flow|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548110|NCT00641537|P2|Participant Flow|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548111|NCT00641537|P1|Participant Flow|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548112|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548113|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548114|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548115|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548116|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548117|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548118|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548148|NCT00641537|E15|Reported Event|Cladribine 3.5 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
548149|NCT00641537|E14|Reported Event|Placebo/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24-Week supplemental follow-up period.
548119|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548120|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548121|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548122|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548123|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548124|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548125|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548126|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548127|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548128|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548129|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548130|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548131|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548132|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548150|NCT00641537|E13|Reported Event|Placebo/Cladribine Low Dose (PPLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
548133|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548134|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548135|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548136|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548137|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548138|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548139|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548140|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548141|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548142|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548143|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548144|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548145|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548146|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548147|NCT00641537|E16|Reported Event|Cladribine 5.25 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
548151|NCT00641537|E12|Reported Event|Cladribine High/Low Dose (HLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
548152|NCT00641537|E11|Reported Event|Cladribine Low/Low Dose (LLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
548153|NCT00641537|E10|Reported Event|Cladribine High Dose/Placebo (HLPP) (24-week Follow-up Period|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
548154|NCT00641537|E9|Reported Event|Cladribine Low/Placebo (LLPP) (24-week Follow-up Period)|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
548155|NCT00641537|E8|Reported Event|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
548156|NCT00641537|E7|Reported Event|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
548157|NCT00641537|E6|Reported Event|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
548158|NCT00641537|E5|Reported Event|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548159|NCT00641537|E4|Reported Event|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548160|NCT00641537|E3|Reported Event|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548161|NCT00641537|E2|Reported Event|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548162|NCT00641537|E1|Reported Event|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
548163|NCT00641147|B3|Baseline|Total|Total of all reporting groups
548164|NCT00641147|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548165|NCT00641147|B1|Baseline|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548166|NCT00641147|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548167|NCT00641147|P1|Participant Flow|Arm I (Curcumin)|"Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months.~Curcumin: Given PO"
548168|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548169|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months.~Curcumin: Given PO"
548170|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548171|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months.~Curcumin: Given PO"
548172|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548173|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin by mouth (PO) twice a day (BID) for 12 months.~Curcumin: Given PO"
548174|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548175|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548176|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548177|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548178|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548179|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548180|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548181|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548182|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548184|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548185|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548186|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548187|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548188|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548189|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548190|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548191|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548192|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO"
548193|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO~Laboratory Biomarker Analysis: Correlative studies"
548194|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548195|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548196|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548197|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548198|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548199|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin 3.0 grams PO BID for 12 months.~Curcumin: Given PO"
548200|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548201|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548202|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548203|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin 3.0 grams PO BID for 12 months.~Curcumin: Given PO"
548204|NCT00641147|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548205|NCT00641147|O1|Outcome|Arm I (Curcumin)|"Patients receive curcumin 3.0 grams PO BID for 12 months.~Curcumin: Given PO"
548206|NCT00641147|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO BID for 12 months.~Placebo: Given PO"
548207|NCT00641147|E1|Reported Event|Arm I (Curcumin)|"Patients receive curcumin PO BID for 12 months.~Curcumin: Given PO"
548208|NCT00641056|B3|Baseline|Total|Total of all reporting groups
548209|NCT00641056|B2|Baseline|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548210|NCT00641056|B1|Baseline|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548211|NCT00641056|P2|Participant Flow|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548212|NCT00641056|P1|Participant Flow|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548213|NCT00641056|O4|Outcome|Insulin Glargine No SU|Patients assigned to the Insulin Glargine No SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met only.
548214|NCT00641056|O3|Outcome|Exenatide Once Weekly No SU|Patients assigned to the Exenatide Once Weekly No SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met only.
548215|NCT00641056|O2|Outcome|Insulin Glargine With SU|Patients assigned to the Insulin Glargine with SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met+SU.
548216|NCT00641056|O1|Outcome|Exenatide Once Weekly With SU|Patients assigned to the Exenatide Once Weekly With SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met+SU.
548217|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548218|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548219|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548220|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548221|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548222|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548223|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548224|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548225|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548226|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548227|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548228|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548229|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548230|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548231|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548232|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548233|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548234|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548235|NCT00641056|E2|Reported Event|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
548236|NCT00641056|E1|Reported Event|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
548237|NCT00641043|B3|Baseline|Total|Total of all reporting groups
548238|NCT00641043|B2|Baseline|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548239|NCT00641043|B1|Baseline|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548240|NCT00641043|P2|Participant Flow|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548241|NCT00641043|P1|Participant Flow|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548242|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548243|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548244|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548245|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548246|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548247|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548248|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548249|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548250|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548251|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548252|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548253|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548254|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548255|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548256|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548257|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548258|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548259|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548260|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548261|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548262|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548263|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548264|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548265|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548266|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548267|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548268|NCT00641043|E2|Reported Event|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
548269|NCT00641043|E1|Reported Event|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
548270|NCT00640978|B1|Baseline|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
548271|NCT00640978|P1|Participant Flow|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
548272|NCT00640978|O1|Outcome|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
548273|NCT00640978|E1|Reported Event|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
548274|NCT00640926|B4|Baseline|Total|Total of all reporting groups
548275|NCT00640926|B3|Baseline|Radezolid 450 mg PO Twice Daily (BID)|
548276|NCT00640926|B2|Baseline|Radezolid 450 mg PO Daily (QD)|
548277|NCT00640926|B1|Baseline|Radezolid 300 mg PO Daily (QD)|
548278|NCT00640926|P3|Participant Flow|Radezolid 450 mg PO Twice Daily (BID)|
548279|NCT00640926|P2|Participant Flow|Radezolid 450 mg PO Daily (QD)|
548280|NCT00640926|P1|Participant Flow|Radezolid 300 mg PO Daily (QD)|
548281|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
548282|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
548283|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
548284|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
548285|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
548286|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
548287|NCT00640926|E3|Reported Event|Radezolid 450 mg PO Twice Daily (BID)|
548288|NCT00640926|E2|Reported Event|Radezolid 450 mg PO Daily (QD)|
548289|NCT00640926|E1|Reported Event|Radezolid 300 mg PO Daily (QD)|
548290|NCT00640835|B3|Baseline|Total|Total of all reporting groups
548291|NCT00640835|B2|Baseline|Buprenorphine/Naloxone Film Strip Administered Buccally|
548292|NCT00640835|B1|Baseline|Buprenorphine/Naloxone Film Strip Administered Sublingually|
548293|NCT00640835|P2|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Buccally|
548294|NCT00640835|P1|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Sublingually|
548295|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
548296|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
548297|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
548298|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
548299|NCT00640835|E2|Reported Event|Buprenorphine/Naloxone Film Strip Administered Buccally|
548300|NCT00640835|E1|Reported Event|Buprenorphine/Naloxone Film Strip Administered Sublingually|
548301|NCT00640822|B4|Baseline|Total|Total of all reporting groups
548302|NCT00640822|B3|Baseline|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
548303|NCT00640822|B2|Baseline|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
548304|NCT00640822|B1|Baseline|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
548305|NCT00640822|P3|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
548306|NCT00640822|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
548307|NCT00640822|P1|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
548308|NCT00640822|O3|Outcome|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
548309|NCT00640822|O2|Outcome|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
548310|NCT00640822|O1|Outcome|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
548311|NCT00640822|E3|Reported Event|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
548312|NCT00640822|E2|Reported Event|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
548313|NCT00640822|E1|Reported Event|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
548314|NCT00640653|B6|Baseline|Total|Total of all reporting groups
548315|NCT00640653|B5|Baseline|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548481|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
549417|NCT00638924|P1|Participant Flow|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
548316|NCT00640653|B4|Baseline|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548317|NCT00640653|B3|Baseline|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548318|NCT00640653|B2|Baseline|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548319|NCT00640653|B1|Baseline|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548320|NCT00640653|P5|Participant Flow|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548321|NCT00640653|P4|Participant Flow|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548322|NCT00640653|P3|Participant Flow|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548323|NCT00640653|P2|Participant Flow|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548324|NCT00640653|P1|Participant Flow|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548325|NCT00640653|O5|Outcome|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548326|NCT00640653|O4|Outcome|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548327|NCT00640653|O3|Outcome|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548328|NCT00640653|O2|Outcome|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548482|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548329|NCT00640653|O1|Outcome|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548330|NCT00640653|O5|Outcome|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548331|NCT00640653|O4|Outcome|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548332|NCT00640653|O3|Outcome|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548333|NCT00640653|O2|Outcome|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548334|NCT00640653|O1|Outcome|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548335|NCT00640653|O5|Outcome|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548336|NCT00640653|O4|Outcome|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548337|NCT00640653|O3|Outcome|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548338|NCT00640653|O2|Outcome|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548339|NCT00640653|O1|Outcome|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548340|NCT00640653|O5|Outcome|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548400|NCT00640601|B1|Baseline|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548341|NCT00640653|O4|Outcome|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548342|NCT00640653|O3|Outcome|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548343|NCT00640653|O2|Outcome|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548344|NCT00640653|O1|Outcome|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548345|NCT00640653|O5|Outcome|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548346|NCT00640653|O4|Outcome|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548347|NCT00640653|O3|Outcome|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548348|NCT00640653|O2|Outcome|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548349|NCT00640653|O1|Outcome|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548350|NCT00640653|E5|Reported Event|Health-promotion Control|"Participants will receive the health promotion control intervention.~Health promotion control intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers. The intervention provides a control for Hawthorne effects to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention."
548351|NCT00640653|E4|Reported Event|Abstinence-only|"Participants will receive the abstinence-only HIV/STD risk-reduction intervention.~Abstinence-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use."
548352|NCT00640653|E3|Reported Event|Safer-sex Only|"Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.~Safer-sex-only HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence."
548353|NCT00640653|E2|Reported Event|Comprehensive-short|"Participants will receive the short comprehensive HIV/STD risk-reduction intervention.~Short comprehensive HIV/STD risk-reduction intervention: Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active."
548478|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548354|NCT00640653|E1|Reported Event|Comprehensive-long|"Participants will receive the long comprehensive HIV/STD risk-reduction intervention.~Long comprehensive HIV/STD risk-reduction intervention: Participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours)."
548355|NCT00640614|B3|Baseline|Total|Total of all reporting groups
548356|NCT00640614|B2|Baseline|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
548357|NCT00640614|B1|Baseline|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
548358|NCT00640614|P2|Participant Flow|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
548359|NCT00640614|P1|Participant Flow|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
548360|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
548361|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
548362|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
548363|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
548364|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
548365|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
548366|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
548367|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
548368|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
548369|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
548370|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
548371|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
548372|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
548373|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
548374|NCT00640614|O3|Outcome|Adhesion|Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.
548375|NCT00640614|O2|Outcome|Itching and Burning|Subject reported sensations of itching and burning were captured at day 2 following patch removal
548376|NCT00640614|O1|Outcome|Panel Irritation|Irritation from the test panel adhesive and/or tape was scored at day 2 following patch removal
548377|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for bronopol and the reference allergen
548378|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bronopol and reference allergen
548379|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for disperse blue and the reference allergen
548380|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for disperse blue and the reference allergen
548381|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for parthenolide and the reference allergen
548382|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for parthenolide and reference allergen
548383|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for bacitracin and the reference allergen
548384|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bacitracin and reference allergen
548385|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for methyldibromo-glutaronitrile and the reference allergen
548386|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for methyldibromo-glutaronitrile and reference allergen
548387|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for hydrocortisone-17-butyrate and the reference allergen
548388|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for hydrocortisone-17-butyrate and reference allergen
548389|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for gold sodium thiosulfate and the reference allergen
548390|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for gold sodium thiosulfate and reference allergen
548391|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
548392|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
548393|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
548394|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
548395|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
548396|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
548397|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
548398|NCT00640614|E2|Reported Event|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
548399|NCT00640614|E1|Reported Event|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
548401|NCT00640601|P1|Participant Flow|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548402|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548403|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548404|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548405|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548406|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548407|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548408|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548409|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548410|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548411|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548412|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548413|NCT00640601|E1|Reported Event|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
548414|NCT00640562|B3|Baseline|Total|Total of all reporting groups
548415|NCT00640562|B2|Baseline|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548416|NCT00640562|B1|Baseline|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548417|NCT00640562|P2|Participant Flow|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548418|NCT00640562|P1|Participant Flow|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548419|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548420|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548421|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548422|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548423|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548424|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548425|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548426|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548427|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548428|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548429|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548430|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548431|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548432|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548433|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548434|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548479|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548435|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548436|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548437|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548438|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548439|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548440|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548441|NCT00640562|E2|Reported Event|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
548442|NCT00640562|E1|Reported Event|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
548443|NCT00640510|B3|Baseline|Total|Total of all reporting groups
548444|NCT00640510|B2|Baseline|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548445|NCT00640510|B1|Baseline|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548446|NCT00640510|P2|Participant Flow|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548447|NCT00640510|P1|Participant Flow|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548448|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548449|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548450|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548480|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548451|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548452|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548453|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548454|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548455|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548456|NCT00640510|E2|Reported Event|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548457|NCT00640510|E1|Reported Event|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
548458|NCT00640393|B1|Baseline|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548459|NCT00640393|P3|Participant Flow|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548460|NCT00640393|P2|Participant Flow|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548461|NCT00640393|P1|Participant Flow|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548462|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548463|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548464|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548465|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548466|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548467|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548468|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548469|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548470|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548471|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548472|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548473|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548474|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548475|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548476|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548477|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548483|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548484|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548485|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548486|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548487|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548488|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548489|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548490|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548491|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548492|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548493|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548494|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548495|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548496|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548497|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548498|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548499|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548500|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548501|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548502|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548503|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548504|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548505|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548506|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548507|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548508|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548509|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548510|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548511|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548512|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548513|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548514|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548515|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548516|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548517|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548518|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548519|NCT00640393|E3|Reported Event|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
548520|NCT00640393|E2|Reported Event|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
548521|NCT00640393|E1|Reported Event|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
548522|NCT00640341|B4|Baseline|Total|Total of all reporting groups
548523|NCT00640341|B3|Baseline|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
548524|NCT00640341|B2|Baseline|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
548525|NCT00640341|B1|Baseline|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
548526|NCT00640341|P3|Participant Flow|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
548527|NCT00640341|P2|Participant Flow|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
548528|NCT00640341|P1|Participant Flow|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
548529|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
548530|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
548531|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
548532|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
548533|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
548534|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
548535|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
548536|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
548537|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
548538|NCT00640341|E3|Reported Event|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
548539|NCT00640341|E2|Reported Event|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
548540|NCT00640341|E1|Reported Event|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
548541|NCT00640328|B7|Baseline|Total|Total of all reporting groups
548542|NCT00640328|B6|Baseline|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548543|NCT00640328|B5|Baseline|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548544|NCT00640328|B4|Baseline|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548545|NCT00640328|B3|Baseline|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548546|NCT00640328|B2|Baseline|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548547|NCT00640328|B1|Baseline|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548548|NCT00640328|P6|Participant Flow|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548549|NCT00640328|P5|Participant Flow|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548550|NCT00640328|P4|Participant Flow|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548551|NCT00640328|P3|Participant Flow|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548552|NCT00640328|P2|Participant Flow|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548553|NCT00640328|P1|Participant Flow|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548554|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548555|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548556|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548557|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548558|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548559|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548560|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548561|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548562|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548563|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548564|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548565|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548566|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548567|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548568|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548569|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548570|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548571|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548572|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548573|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548574|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548575|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548576|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548577|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548578|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548579|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548580|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548581|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548582|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548583|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548584|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548585|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548753|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
549418|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
548586|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548587|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548588|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548589|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548590|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548591|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548592|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548593|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548594|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548595|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548596|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548597|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548598|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548599|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548600|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548601|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548602|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548618|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548603|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548604|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548605|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548606|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548607|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548608|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548609|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548610|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548611|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548612|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548613|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548614|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548615|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548616|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548617|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548754|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548755|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548619|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548620|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548621|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548622|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548623|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548624|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548625|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548626|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
548627|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548628|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548629|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
548630|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
548631|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
548632|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548633|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548634|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548756|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548895|NCT00640250|O13|Outcome|Bronopol 0.1 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548635|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548636|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548637|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548638|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548639|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548640|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548641|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548642|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548643|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548644|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548645|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before consideAfter completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.ring progression to the 700 mg dose.
548757|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548758|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548896|NCT00640250|O12|Outcome|Bronopol 0.750 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548646|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548647|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548648|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548649|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548650|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548651|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548652|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548653|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548654|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548655|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548656|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548759|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548760|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548897|NCT00640250|O11|Outcome|Bronopol 0.500 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548657|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548658|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548659|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548660|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548661|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548662|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548663|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548664|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548665|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548666|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548667|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548761|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548762|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548668|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548669|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548670|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548671|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548672|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548673|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548674|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548675|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548676|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548677|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548678|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548701|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548679|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548680|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548681|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548682|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548683|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548684|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548685|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548686|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548687|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548688|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548689|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548747|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548748|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548894|NCT00640250|O14|Outcome|Bronopol 0.250 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548690|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548691|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548692|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548693|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548694|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548695|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548696|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548697|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548698|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548699|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548700|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548749|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548750|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548702|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548703|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548704|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548705|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548706|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548707|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548708|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548709|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548710|NCT00640328|E6|Reported Event|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548711|NCT00640328|E5|Reported Event|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548712|NCT00640328|E4|Reported Event|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548751|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548752|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548713|NCT00640328|E3|Reported Event|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548714|NCT00640328|E2|Reported Event|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548715|NCT00640328|E1|Reported Event|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
548716|NCT00640315|B3|Baseline|Total|Total of all reporting groups
548717|NCT00640315|B2|Baseline|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548718|NCT00640315|B1|Baseline|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548719|NCT00640315|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548720|NCT00640315|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548721|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548722|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548723|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548724|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548725|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548726|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548727|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548728|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548729|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548730|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548731|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548732|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548733|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548734|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548735|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548736|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548737|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548738|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548739|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548740|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548741|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548742|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548743|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548744|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548745|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548746|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548763|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548764|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548765|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548766|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548767|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548768|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548769|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548770|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548771|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548772|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548773|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548774|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548775|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548776|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548777|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548778|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548779|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548780|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548781|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548782|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548783|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548784|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548785|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548786|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548787|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548788|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548789|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548790|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548791|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548792|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548793|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548794|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548795|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548796|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548797|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548798|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548799|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548800|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548801|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548802|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548803|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
549419|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
548804|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548805|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548806|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548807|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548808|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548809|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548810|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548811|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548812|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548813|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548814|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548815|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548816|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548817|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548818|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548819|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548820|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548821|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548822|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548823|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548824|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548825|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548826|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548827|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548828|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548829|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548830|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548831|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548832|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548833|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548834|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548835|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548836|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548837|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548838|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548839|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548840|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548841|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548842|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548843|NCT00640315|E2|Reported Event|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
548844|NCT00640315|E1|Reported Event|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
548845|NCT00640250|B1|Baseline|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.
548846|NCT00640250|P1|Participant Flow|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.
548847|NCT00640250|O2|Outcome|Adverse Events Not Related|Number of adverse events not related to investigational or reference allergens
548848|NCT00640250|O1|Outcome|Adverse Events Related to Investigational Panel|Number of reported adverse events related to investigational or reference allergens.
548849|NCT00640250|O20|Outcome|Bronopol 0.750 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548850|NCT00640250|O19|Outcome|Bronopol 0.500 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548851|NCT00640250|O18|Outcome|Bronopol 0.250 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548852|NCT00640250|O17|Outcome|Bronopol 0.125 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548853|NCT00640250|O16|Outcome|Bronopol 0.750 mg/cm2 LateReactions|Percentage of subjects who exhibited late reactions
548854|NCT00640250|O15|Outcome|Bronopol 0.500 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
548855|NCT00640250|O14|Outcome|Bronopol 0.250 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
548856|NCT00640250|O13|Outcome|Bronopol 0.125 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
548857|NCT00640250|O12|Outcome|Negative Control Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548858|NCT00640250|O11|Outcome|Disperse Blue 0.150 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548859|NCT00640250|O10|Outcome|Disperse Blue 0.050 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548860|NCT00640250|O9|Outcome|Disperse Blue 0.017 mg/cm2 Persistent Reactions|Percentage of subjects who exhibited persistent reactions
548861|NCT00640250|O8|Outcome|Negative Control Late Reactions|Percentage of subjects who exhibited late reactions
548862|NCT00640250|O7|Outcome|Disperse Blue 0.150 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
548863|NCT00640250|O6|Outcome|Disperse Blue 0.050 mg/cm2 Late Reactions|Percentage of subjects who exhibited late reactions
548864|NCT00640250|O5|Outcome|Disperse Blue 0.017 Late Reactions|Percentage of subjects who exhibited late reactions
548865|NCT00640250|O4|Outcome|Bronopol Itching and/or Burning|Percentage of subjects who exhibited itching and/or burning to bronopol panel
548866|NCT00640250|O3|Outcome|Disperse Blue Itching and/or Burning|Percentage of subjects who exhibited itching and/or burning to disperse blue panel
548867|NCT00640250|O2|Outcome|Bronopol Irritation Reactions|Percentage of subjects who exhibited irritation (tape reactions) to bronopol panel
548868|NCT00640250|O1|Outcome|Disperse Blue Irritation Reactions|Percentage of subjects who exhibited irritation (tape reactions) to disperse blue panel
548869|NCT00640250|O7|Outcome|Bronopol 0.750 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
548870|NCT00640250|O6|Outcome|Bronopol 0.500 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
548871|NCT00640250|O5|Outcome|Bronopol 0.250 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
548872|NCT00640250|O4|Outcome|Bronopol 0.125 mg/cm2|Concordance between bronopol and the reference petrolatum allergen
548873|NCT00640250|O3|Outcome|Disperse Blue 0.150 mg/cm2|Concordance between disperse blue and the reference petrolatum allergen
548874|NCT00640250|O2|Outcome|Disperse Blue 0.050 mg/cm2|Concordance between disperse blue and the reference petrolatum allergen
548875|NCT00640250|O1|Outcome|Disperse Blue 0.017 mg/cm2|Concordance between disperse blue and the reference petrolatum allergen
548876|NCT00640250|O16|Outcome|Bronopol 0.750 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548877|NCT00640250|O15|Outcome|Bronopol 0.500 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548878|NCT00640250|O14|Outcome|Bronopol 0.250 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548879|NCT00640250|O13|Outcome|Bronopol 0.125 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548880|NCT00640250|O12|Outcome|Bronopol 0.750 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548881|NCT00640250|O11|Outcome|Bronopol 0.500 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548882|NCT00640250|O10|Outcome|Bronopol 0.250 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548883|NCT00640250|O9|Outcome|Bronopol 0.125 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548884|NCT00640250|O8|Outcome|Bronopol 0.750 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548885|NCT00640250|O7|Outcome|Bronopol 0.500 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548886|NCT00640250|O6|Outcome|Bronopol 0.250 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548887|NCT00640250|O5|Outcome|Bronopol 0.125 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548888|NCT00640250|O4|Outcome|Bronopol 0.750 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548889|NCT00640250|O3|Outcome|Bronopol 0.500 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548890|NCT00640250|O2|Outcome|Bronopol 0.250 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548891|NCT00640250|O1|Outcome|Bronopol 0.125 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548892|NCT00640250|O16|Outcome|Bronopol 0.750 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548893|NCT00640250|O15|Outcome|Bronopol 0.500 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548898|NCT00640250|O10|Outcome|Bronopol 0.250 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548899|NCT00640250|O9|Outcome|Bronopol 0.1 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548900|NCT00640250|O8|Outcome|Bronopol 0.750 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548901|NCT00640250|O7|Outcome|Bronopol 0.500 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548902|NCT00640250|O6|Outcome|Bronopol 0.250 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548903|NCT00640250|O5|Outcome|Bronopol 0.1 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548904|NCT00640250|O4|Outcome|Bronopol 0.750 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548905|NCT00640250|O3|Outcome|Bronopol 0.500 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548906|NCT00640250|O2|Outcome|Bronopol 0.250 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548907|NCT00640250|O1|Outcome|Bronopol 0.1 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548908|NCT00640250|O16|Outcome|Negative Control Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548909|NCT00640250|O15|Outcome|Disperse Blue 0.150 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548910|NCT00640250|O14|Outcome|Disperse Blue 0.050 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548911|NCT00640250|O13|Outcome|Disperse Blue 0.017 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 4
548912|NCT00640250|O12|Outcome|Negative Control Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548913|NCT00640250|O11|Outcome|Disperse Blue 0.150 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548914|NCT00640250|O10|Outcome|Disperse Blue 0.050 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548915|NCT00640250|O9|Outcome|Disperse Blue 0.017 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 4
548916|NCT00640250|O8|Outcome|Negative Control Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548917|NCT00640250|O7|Outcome|Disperse Blue 0.150 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548918|NCT00640250|O6|Outcome|Disperse Blue 0.050 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548919|NCT00640250|O5|Outcome|Disperse Blue 0.017 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 4
548920|NCT00640250|O4|Outcome|Negative Control Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548921|NCT00640250|O3|Outcome|Disperse Blue 0.150 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548922|NCT00640250|O2|Outcome|Disperse Blue 0.050 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548923|NCT00640250|O1|Outcome|Disperse Blue 0.017 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 4
548924|NCT00640250|O16|Outcome|Negative Control Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548925|NCT00640250|O15|Outcome|Disperse Blue 0.150 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548926|NCT00640250|O14|Outcome|Disperse Blue 0.050 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548927|NCT00640250|O13|Outcome|Disperse Blue 0.017 mg/cm2 Doubtful Reactions|Percentage of subjects who exhibited doubtful reactions at visit 3
548928|NCT00640250|O12|Outcome|Negative Control Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548929|NCT00640250|O11|Outcome|Disperse Blue 0.150 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548930|NCT00640250|O10|Outcome|Disperse Blue 0.050 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548931|NCT00640250|O9|Outcome|Disperse Blue 0.017 mg/cm2 Irritant Reactions|Percentage of subjects who exhibited irritant reactions at visit 3
548932|NCT00640250|O8|Outcome|Negative Control Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548933|NCT00640250|O7|Outcome|Disperse Blue 0.150 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548934|NCT00640250|O6|Outcome|Disperse Blue 0.050 mg/cm2 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548935|NCT00640250|O5|Outcome|Disperse Blue 0.017 Negative Reactions|Percentage of subjects who exhibited negative reactions at visit 3
548936|NCT00640250|O4|Outcome|Negative Control Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548937|NCT00640250|O3|Outcome|Disperse Blue 0.150 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548938|NCT00640250|O2|Outcome|Disperse Blue 0.050 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548939|NCT00640250|O1|Outcome|Disperse Blue 0.017 mg/cm2 Positive Reactions|Percentage of subjects who exhibited positive reactions at visit 3
548940|NCT00640250|O7|Outcome|Bronopol 0.750 mg/cm2|Percentage of positive test responses
548941|NCT00640250|O6|Outcome|Bronopol 0.500 mg/cm2|Percentage of positive test responses
548942|NCT00640250|O5|Outcome|Bronopol 0.250 mg/cm2|Percentage of positive test responses
548943|NCT00640250|O4|Outcome|Bronopol 0.125 mg/cm2|Percentage of positive test responses
548944|NCT00640250|O3|Outcome|Disperse Blue 0.150 mg/cm2|Percentage of positive test responses
548945|NCT00640250|O2|Outcome|Disperse Blue 0.050 mg/cm2|Percentage of positive test responses
548946|NCT00640250|O1|Outcome|Disperse Blue 0.017 mg/cm2|Percentage of positive test responses
548947|NCT00640250|E1|Reported Event|All Subjects|
548948|NCT00640224|B5|Baseline|Total|Total of all reporting groups
548949|NCT00640224|B4|Baseline|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548950|NCT00640224|B3|Baseline|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548951|NCT00640224|B2|Baseline|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548952|NCT00640224|B1|Baseline|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548953|NCT00640224|P4|Participant Flow|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548954|NCT00640224|P3|Participant Flow|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548955|NCT00640224|P2|Participant Flow|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548956|NCT00640224|P1|Participant Flow|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548957|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548958|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548959|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548960|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548961|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548962|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548963|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548964|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548965|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548966|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548967|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548968|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548969|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548970|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548971|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548972|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548973|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548974|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548975|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548976|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548977|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548978|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548979|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548980|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548981|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548982|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548983|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548984|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548985|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548986|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548987|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548988|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548989|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548990|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548991|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548992|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548993|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548994|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548995|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
548996|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
548997|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
548998|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
548999|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549000|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549001|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549002|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549003|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549004|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549005|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549006|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549007|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549008|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549009|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549010|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549011|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549012|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549013|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549014|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549015|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549016|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549017|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549018|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549019|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549020|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549021|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549022|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549023|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549024|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549025|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549026|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549027|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549028|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549029|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549030|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549031|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549032|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549033|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549034|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549035|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549036|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549037|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549038|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549039|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549040|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549041|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549042|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549043|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549044|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549045|NCT00640224|O4|Outcome|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549046|NCT00640224|O3|Outcome|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549047|NCT00640224|O2|Outcome|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549048|NCT00640224|O1|Outcome|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549049|NCT00640224|E4|Reported Event|Lean Without PCOS|Lean healthy girls without PCOS to serve as controls for the cardiovascular markers
549050|NCT00640224|E3|Reported Event|Overweight/Obese Without PCOS|Overweight adolescent females without PCOS to use as comparison of normal developmental changes.
549051|NCT00640224|E2|Reported Event|Drospirenone/Ethinyl Estradiol|"Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol~drospirenone/ethinyl estradiol: 1 tab (3mg/30mcg) daily for 6 months"
549052|NCT00640224|E1|Reported Event|Rosiglitazone|"Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone~rosiglitazone: 4 mg daily for 6 months"
549053|NCT00640042|B1|Baseline|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549054|NCT00640042|P1|Participant Flow|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549055|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549056|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549057|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549058|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549059|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549060|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549061|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549062|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549063|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549064|NCT00640042|E1|Reported Event|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
549065|NCT00640016|B5|Baseline|Total|Total of all reporting groups
549066|NCT00640016|B4|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549067|NCT00640016|B3|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549068|NCT00640016|B2|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549069|NCT00640016|B1|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
549070|NCT00640016|P4|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549071|NCT00640016|P3|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549072|NCT00640016|P2|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549073|NCT00640016|P1|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
549074|NCT00640016|O4|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549075|NCT00640016|O3|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549076|NCT00640016|O2|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549077|NCT00640016|O1|Outcome|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
549078|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549079|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549080|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549081|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549082|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549083|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549084|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549085|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549086|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549087|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549088|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549089|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549090|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549091|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549092|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549420|NCT00638924|E1|Reported Event|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
549093|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549094|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549095|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549096|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549097|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549098|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549099|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549100|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549101|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549102|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549103|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549104|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549105|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549106|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549107|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549108|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549109|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549110|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549111|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549112|NCT00640016|E4|Reported Event|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549113|NCT00640016|E3|Reported Event|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549114|NCT00640016|E2|Reported Event|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
549115|NCT00640016|E1|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56
549116|NCT00639860|B1|Baseline|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549117|NCT00639860|P1|Participant Flow|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549118|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549119|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549120|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549121|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549122|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549123|NCT00639860|E1|Reported Event|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
549124|NCT00639769|B1|Baseline|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
549125|NCT00639769|P1|Participant Flow|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
549126|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
549127|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
549128|NCT00639769|E1|Reported Event|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
549146|NCT00639678|O1|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549470|NCT00638690|B3|Baseline|Total|Total of all reporting groups
549129|NCT00639717|B1|Baseline|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549130|NCT00639717|P1|Participant Flow|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549131|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549132|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549133|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549134|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549135|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549136|NCT00639717|E1|Reported Event|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
549137|NCT00639678|B5|Baseline|Total|Total of all reporting groups
549138|NCT00639678|B4|Baseline|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549139|NCT00639678|B3|Baseline|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549140|NCT00639678|B2|Baseline|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549141|NCT00639678|B1|Baseline|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549142|NCT00639678|P4|Participant Flow|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549143|NCT00639678|P3|Participant Flow|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549144|NCT00639678|P2|Participant Flow|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549145|NCT00639678|P1|Participant Flow|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549471|NCT00638690|B2|Baseline|Placebo|Placebo plus prednisone/prednisolone
549147|NCT00639678|O1|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549148|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549149|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549150|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549151|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549152|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549153|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549154|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549155|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549156|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549157|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549158|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549159|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549160|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549161|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549162|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549163|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549164|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549165|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549166|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549167|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549168|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549169|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549170|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549171|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549172|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549238|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549173|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549174|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549175|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549176|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549177|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549178|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549179|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549180|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549181|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549182|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549183|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549184|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549185|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549186|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549187|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549188|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549189|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549190|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549191|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549192|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549193|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549194|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549195|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549196|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549197|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549198|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549199|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549200|NCT00639678|E4|Reported Event|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549201|NCT00639678|E3|Reported Event|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
549202|NCT00639678|E2|Reported Event|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
549203|NCT00639678|E1|Reported Event|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
549204|NCT00639626|B1|Baseline|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
549205|NCT00639626|P1|Participant Flow|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
549206|NCT00639626|O1|Outcome|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
549207|NCT00639626|O1|Outcome|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
549208|NCT00639626|E1|Reported Event|Levemir|insulin detemir [rDNA origin] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
549209|NCT00639509|B1|Baseline|IMC-A12|Participants will receive IMC-A12 at a dose of 6mg/kg IV over 1 hour on Day 1 every week.
549210|NCT00639509|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
549211|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
549212|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
549213|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
549214|NCT00639509|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
549215|NCT00639457|B3|Baseline|Total|Total of all reporting groups
549216|NCT00639457|B2|Baseline|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549217|NCT00639457|B1|Baseline|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549218|NCT00639457|P2|Participant Flow|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549219|NCT00639457|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549220|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549221|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549222|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549223|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549224|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549225|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549226|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549227|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549228|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549229|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549230|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549231|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549232|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549233|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549234|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549235|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549236|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549237|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549240|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549241|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549242|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549243|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549244|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549245|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549246|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549247|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549248|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549249|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549250|NCT00639457|E2|Reported Event|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
549251|NCT00639457|E1|Reported Event|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
549252|NCT00639418|B5|Baseline|Total|Total of all reporting groups
549253|NCT00639418|B4|Baseline|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
549254|NCT00639418|B3|Baseline|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
549255|NCT00639418|B2|Baseline|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
549256|NCT00639418|B1|Baseline|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
549257|NCT00639418|P4|Participant Flow|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
549258|NCT00639418|P3|Participant Flow|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
549259|NCT00639418|P2|Participant Flow|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
549260|NCT00639418|P1|Participant Flow|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
549261|NCT00639418|O4|Outcome|Staff Attitudes: Number of Doses|Number of sites that agreed or somewhat agreed that they strongly recommend that previously unvaccinated patients less than 9 years of age receive 2 doses of influenza vaccine
549262|NCT00639418|O3|Outcome|Staff Attitudes: 5 to 18 Year Old Patients|Number of sites that agreed or somewhat agreed that they strongly recommend that patients 5 to 18 years of age without high-risk medical conditions be vaccinated against influenza each year
549263|NCT00639418|O2|Outcome|Staff Attitudes: 6 Months to 5 Year Old Patients|Number of sites that strongly recommend that patients 6 months to 5 years of age be vaccinated against influenza each year.
549264|NCT00639418|O1|Outcome|Staff Attitudes: High-risk Medical Conditions|Number of sites that agreed or somewhat agreed that they strongly recommend seasonal influenza vaccination to patients 5 to 18 years of age with high-risk medical conditions
549265|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
549266|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
549267|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
549268|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
549269|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
549270|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
549271|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
549272|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
549273|NCT00639418|E4|Reported Event|Children 9 to 18 Years|AEs were not collected in this observational study of physician vaccination practices.
549274|NCT00639418|E3|Reported Event|Children 5 to 8 Years|AEs were not collected in this observational study of physician vaccination practices.
549275|NCT00639418|E2|Reported Event|Children 24 to 59 Months|AEs were not collected in this observational study of physician vaccination practices.
549276|NCT00639418|E1|Reported Event|Children 6 to 23 Months|AEs were not collected in this observational study of physician vaccination practices.
549277|NCT00639379|B1|Baseline|Total Completed Participants|
549278|NCT00639379|P2|Participant Flow|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
549279|NCT00639379|P1|Participant Flow|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
549280|NCT00639379|O2|Outcome|Alphafilcon A Toric|
549290|NCT00639379|E2|Reported Event|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
549291|NCT00639379|E1|Reported Event|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
549292|NCT00639223|B3|Baseline|Total|Total of all reporting groups
549293|NCT00639223|B2|Baseline|Red Yeast Rice|
549294|NCT00639223|B1|Baseline|Pravastatin|
549295|NCT00639223|P2|Participant Flow|Red Yeast Rice|
549296|NCT00639223|P1|Participant Flow|Pravastatin|
549297|NCT00639223|O2|Outcome|Red Yeast Rice|
549298|NCT00639223|O1|Outcome|Pravastatin|
549299|NCT00639223|O2|Outcome|Red Yeast Rice|
549300|NCT00639223|O1|Outcome|Pravastatin|
549301|NCT00639223|E2|Reported Event|Red Yeast Rice|
549302|NCT00639223|E1|Reported Event|Pravastatin|
549303|NCT00639158|B3|Baseline|Total|Total of all reporting groups
549304|NCT00639158|B2|Baseline|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549305|NCT00639158|B1|Baseline|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549306|NCT00639158|P2|Participant Flow|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549307|NCT00639158|P1|Participant Flow|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549308|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549309|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549310|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549311|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549312|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549313|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549314|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549315|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549316|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549317|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549318|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549319|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549320|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549321|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549322|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549323|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549324|NCT00639158|E2|Reported Event|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
549325|NCT00639158|E1|Reported Event|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
549326|NCT00639093|B3|Baseline|Total|Total of all reporting groups
549327|NCT00639093|B2|Baseline|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
549328|NCT00639093|B1|Baseline|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
549329|NCT00639093|P2|Participant Flow|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
549330|NCT00639093|P1|Participant Flow|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
549331|NCT00639093|O2|Outcome|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
549332|NCT00639093|O1|Outcome|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
549333|NCT00639093|E2|Reported Event|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
549334|NCT00639093|E1|Reported Event|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
549335|NCT00639002|B1|Baseline|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
550594|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
549336|NCT00639002|P1|Participant Flow|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
549337|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
549338|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
549339|NCT00639002|E2|Reported Event|Ruxolitinib + Dexamethasone|Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
549340|NCT00639002|E1|Reported Event|Ruxolitinib|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent.
549341|NCT00638989|B4|Baseline|Total|Total of all reporting groups
549342|NCT00638989|B3|Baseline|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549343|NCT00638989|B2|Baseline|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549344|NCT00638989|B1|Baseline|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549345|NCT00638989|P3|Participant Flow|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549346|NCT00638989|P2|Participant Flow|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549347|NCT00638989|P1|Participant Flow|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549348|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549349|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549350|NCT00638989|O2|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549351|NCT00638989|O1|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549352|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549353|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549354|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549355|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549356|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549357|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549358|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549359|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549360|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549361|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549362|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549363|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549364|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549365|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549366|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549367|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549368|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549369|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549370|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549371|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549372|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549373|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549374|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549375|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549376|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549377|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549378|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549379|NCT00638989|O2|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549380|NCT00638989|O1|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549381|NCT00638989|E3|Reported Event|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
549382|NCT00638989|E2|Reported Event|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
549383|NCT00638989|E1|Reported Event|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
549384|NCT00638963|B3|Baseline|Total|Total of all reporting groups
549385|NCT00638963|B2|Baseline|Observational|No temozolomide treatment
549386|NCT00638963|B1|Baseline|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549387|NCT00638963|P2|Participant Flow|Observational|No temozolomide treatment
549388|NCT00638963|P1|Participant Flow|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549389|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549390|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549391|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549392|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549393|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549394|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
549395|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549396|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
549397|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549398|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
549399|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549400|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
549401|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549402|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
549403|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549404|NCT00638963|E2|Reported Event|Observational|No temozolomide treatment
549405|NCT00638963|E1|Reported Event|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
549406|NCT00638937|B1|Baseline|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
549407|NCT00638937|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: 175mg given PO daily~laboratory biomarker analysis: Correlative studies"
549408|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
549409|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
549410|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
549411|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
549412|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
549413|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
549414|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
549415|NCT00638937|E1|Reported Event|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
549416|NCT00638924|B1|Baseline|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
549421|NCT00638885|B1|Baseline|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
549422|NCT00638885|P1|Participant Flow|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
549423|NCT00638885|O1|Outcome|Vietnam Veteran Twins|Vietnam veteran twins with and without PTSD.
549424|NCT00638885|E1|Reported Event|Vietnam Twins With and Without PTSD|
549425|NCT00638846|B3|Baseline|Total|Total of all reporting groups
549426|NCT00638846|B2|Baseline|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549427|NCT00638846|B1|Baseline|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549428|NCT00638846|P2|Participant Flow|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549429|NCT00638846|P1|Participant Flow|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549430|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549431|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549432|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549433|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549434|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549435|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549436|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549437|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549438|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549439|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549440|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549441|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549442|NCT00638846|E2|Reported Event|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
549443|NCT00638846|E1|Reported Event|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
549444|NCT00638820|B1|Baseline|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
549445|NCT00638820|P1|Participant Flow|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
549446|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
549447|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
549448|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
549449|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
549450|NCT00638820|E1|Reported Event|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
549451|NCT00638716|B4|Baseline|Total|Total of all reporting groups
549452|NCT00638716|B3|Baseline|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
549453|NCT00638716|B2|Baseline|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
549454|NCT00638716|B1|Baseline|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
549455|NCT00638716|P3|Participant Flow|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
549456|NCT00638716|P2|Participant Flow|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
549457|NCT00638716|P1|Participant Flow|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
549458|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
549459|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
549460|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
549461|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
549462|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
549463|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
549464|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
549465|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
549466|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
549467|NCT00638716|E3|Reported Event|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
549468|NCT00638716|E2|Reported Event|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
549469|NCT00638716|E1|Reported Event|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
549472|NCT00638690|B1|Baseline|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
549473|NCT00638690|P2|Participant Flow|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
549474|NCT00638690|P1|Participant Flow|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
549475|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
549476|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
549477|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
549478|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
549479|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
549480|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
549481|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
549482|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
549483|NCT00638690|E3|Reported Event|Placebo to Abiraterone Acetate|Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
549484|NCT00638690|E2|Reported Event|Placebo|Placebo plus prednisone/prednisolone
549485|NCT00638690|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
549486|NCT00638651|B1|Baseline|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
549487|NCT00638651|P1|Participant Flow|Laser Treatment With Imiquimod Cream or Placebo|Participants with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
549488|NCT00638651|O2|Outcome|Laser Treatment With Placebo Cream (Group 2)|"The tattoo will be treated with laser and placebo topical cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy"
549489|NCT00638651|O1|Outcome|Laser Treatment With Imiquimod (Group 1)|"The tattoo will be treated with laser and imiquimod 5% cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy~Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month"
549490|NCT00638651|E1|Reported Event|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
549491|NCT00638443|B1|Baseline|All Study Participants|"Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days~Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days"
549492|NCT00638443|P2|Participant Flow|Diphenhydramine First, Pregabalin Second|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days; washout 7 days; Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
549493|NCT00638443|P1|Participant Flow|Pregabalin First, Diphenhydramine Second|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; washout 7 days; Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549494|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549495|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549496|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549497|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549498|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549499|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549500|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549574|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549501|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549502|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549503|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549504|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549505|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549506|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549507|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549508|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549509|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549510|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549511|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549512|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549513|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549514|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
549515|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
549516|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
549517|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
549518|NCT00638443|E2|Reported Event|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
549519|NCT00638443|E1|Reported Event|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
549520|NCT00638378|B1|Baseline|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
549521|NCT00638378|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
549522|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
549523|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
549524|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
549525|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
549526|NCT00638378|E1|Reported Event|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
549527|NCT00638365|B4|Baseline|Total|Total of all reporting groups
549528|NCT00638365|B3|Baseline|KB001, 10 mg/kg|
549529|NCT00638365|B2|Baseline|KB001, 3 mg/kg|
549530|NCT00638365|B1|Baseline|Placebo|
549531|NCT00638365|P3|Participant Flow|KB001, 10 mg/kg|
549532|NCT00638365|P2|Participant Flow|KB001, 3 mg/kg|
549533|NCT00638365|P1|Participant Flow|Placebo|
549534|NCT00638365|O3|Outcome|KB001, 10 mg/kg|
549535|NCT00638365|O2|Outcome|KB001, 3 mg/kg|
549536|NCT00638365|O1|Outcome|Placebo|
549537|NCT00638365|E3|Reported Event|KB001, 10 mg/kg|
549538|NCT00638365|E2|Reported Event|KB001, 3 mg/kg|
549539|NCT00638365|E1|Reported Event|Placebo|
549540|NCT00638235|B10|Baseline|Total|Total of all reporting groups
549541|NCT00638235|B9|Baseline|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549542|NCT00638235|B8|Baseline|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549575|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549543|NCT00638235|B7|Baseline|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549544|NCT00638235|B6|Baseline|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549545|NCT00638235|B5|Baseline|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549546|NCT00638235|B4|Baseline|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549547|NCT00638235|B3|Baseline|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse
549548|NCT00638235|B2|Baseline|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549549|NCT00638235|B1|Baseline|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549550|NCT00638235|P9|Participant Flow|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549551|NCT00638235|P8|Participant Flow|Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
549552|NCT00638235|P7|Participant Flow|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549553|NCT00638235|P6|Participant Flow|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549554|NCT00638235|P5|Participant Flow|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549555|NCT00638235|P4|Participant Flow|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549556|NCT00638235|P3|Participant Flow|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549557|NCT00638235|P2|Participant Flow|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549558|NCT00638235|P1|Participant Flow|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549559|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549560|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549561|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549562|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549563|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549564|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549565|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549566|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549567|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549568|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549569|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549570|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549571|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549572|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549573|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549576|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549577|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549578|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549579|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549580|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549581|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549582|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549583|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549584|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549585|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549586|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549587|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549588|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549589|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549590|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549591|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549592|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549593|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549594|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549595|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549596|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549597|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549598|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549599|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549600|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549601|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549602|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549603|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549604|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549605|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549606|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549639|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549607|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549608|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549609|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549610|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549611|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549612|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549613|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549614|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, Fot PROPEL Study Use Only)
549615|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549616|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549617|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549618|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549619|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549620|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549621|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549622|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549623|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549624|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549625|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549626|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549627|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549628|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549629|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549630|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549631|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549632|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549633|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549634|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549635|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549636|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549637|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549638|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549640|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549641|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549642|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549643|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549644|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549645|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549646|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549647|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549648|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549649|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549650|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549651|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549652|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549653|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549654|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549655|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IVmodels"
549656|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549657|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549658|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549659|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549660|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549661|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549662|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549663|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549664|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549665|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549666|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549667|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549668|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549669|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549670|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549671|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549672|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549673|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549674|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549675|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549676|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549677|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549678|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549679|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549680|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549681|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549682|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549683|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549684|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549685|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549686|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549687|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549688|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549689|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549690|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549691|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549692|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549693|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549694|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549695|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549696|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549697|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549698|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549699|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549700|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549701|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549702|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549703|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
550101|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
549704|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549705|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549706|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549707|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549708|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549709|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549710|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549711|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549712|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549713|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549714|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549715|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549716|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549717|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549718|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549719|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549720|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549721|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549722|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549723|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549724|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549725|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549726|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549727|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549728|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549729|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549730|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549731|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549732|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549733|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549734|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
550028|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
549735|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549736|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549737|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549738|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549739|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549740|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549741|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549742|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549743|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549744|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549745|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549746|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549747|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549748|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549749|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549750|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549751|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549752|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549753|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549754|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549755|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549756|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549757|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549758|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549759|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549760|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549761|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549762|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549763|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549764|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549765|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549766|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
550102|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
549767|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549768|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549769|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549770|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549771|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549772|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549773|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549774|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549775|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549776|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549777|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549778|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549779|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549780|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549781|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549782|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549783|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549784|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549785|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549786|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549787|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549788|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549789|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549790|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549791|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549792|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549793|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549794|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549795|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549796|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549797|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
550478|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
549798|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549799|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549800|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549801|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549802|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549803|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549804|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549805|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549806|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549807|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549808|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549809|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549810|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549811|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549812|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549813|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549814|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549815|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549816|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549817|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549818|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549819|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549820|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549821|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549822|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549823|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549824|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549825|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549826|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549827|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549828|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549829|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549830|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549831|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549832|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549833|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549834|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549835|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549836|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549837|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549838|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549839|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549840|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549841|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549842|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549843|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549844|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549845|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549846|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549847|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549848|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549849|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549850|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549851|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549852|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549853|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549854|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549855|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549856|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549857|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549858|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549859|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549860|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549861|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549862|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549863|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549864|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549865|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549866|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549867|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US & Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549868|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549869|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549870|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549871|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549872|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549873|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549874|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549875|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549876|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549877|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549878|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549879|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549880|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549881|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549882|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549883|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549884|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549885|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549886|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549887|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549888|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549889|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects had their 24M visit because next generation of Perigee was already under trial in Phase III/IV"
549890|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549891|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549892|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
550595|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
549893|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549894|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549895|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549896|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549897|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549898|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549899|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549900|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549901|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549902|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549903|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549904|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549905|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549906|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549907|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549908|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549909|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549910|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549911|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549912|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549913|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549914|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549915|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549916|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549917|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549918|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549919|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549920|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549921|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549922|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549923|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549924|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549925|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549926|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549927|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549928|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549929|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
549930|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549931|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549932|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549933|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549934|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549935|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549936|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549937|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549938|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
549939|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549940|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549941|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549942|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549943|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
549944|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549945|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549946|NCT00638235|E9|Reported Event|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
549947|NCT00638235|E8|Reported Event|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
549948|NCT00638235|E7|Reported Event|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
549949|NCT00638235|E6|Reported Event|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
549950|NCT00638235|E5|Reported Event|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549951|NCT00638235|E4|Reported Event|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
549952|NCT00638235|E3|Reported Event|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
549953|NCT00638235|E2|Reported Event|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
549954|NCT00638235|E1|Reported Event|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
549955|NCT00638222|B4|Baseline|Total|Total of all reporting groups
550029|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
549956|NCT00638222|B3|Baseline|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
549957|NCT00638222|B2|Baseline|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
549958|NCT00638222|B1|Baseline|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
549959|NCT00638222|P3|Participant Flow|All Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
549960|NCT00638222|P2|Participant Flow|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
549961|NCT00638222|P1|Participant Flow|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
549962|NCT00638222|O2|Outcome|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
549963|NCT00638222|O1|Outcome|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
549964|NCT00638222|E3|Reported Event|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
549965|NCT00638222|E2|Reported Event|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
549966|NCT00638222|E1|Reported Event|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
549967|NCT00638183|B1|Baseline|Spiriva Treatment|Daily Therapy
549968|NCT00638183|P1|Participant Flow|Spiriva Treatment|Daily Therapy
549969|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
549970|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
549971|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
549972|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
549973|NCT00638183|E1|Reported Event|Spiriva Treatment|Daily Therapy
549974|NCT00638157|B3|Baseline|Total|Total of all reporting groups
549975|NCT00638157|B2|Baseline|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
549976|NCT00638157|B1|Baseline|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
549977|NCT00638157|P2|Participant Flow|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
549978|NCT00638157|P1|Participant Flow|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
549979|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
549980|NCT00638157|O1|Outcome|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
549981|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
549982|NCT00638157|O1|Outcome|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
549983|NCT00638157|E2|Reported Event|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
549984|NCT00638157|E1|Reported Event|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
549985|NCT00638027|B3|Baseline|Total|Total of all reporting groups
549986|NCT00638027|B2|Baseline|Placebo|Placebo arm
549987|NCT00638027|B1|Baseline|Memantine|Memantine 10 mg bid
549988|NCT00638027|P2|Participant Flow|Placebo|Placebo arm
549989|NCT00638027|P1|Participant Flow|Memantine|Memantine 10 mg bid
549990|NCT00638027|O2|Outcome|Placebo|Placebo arm
549991|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
549992|NCT00638027|O2|Outcome|Placebo|Placebo arm
549993|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
549994|NCT00638027|O2|Outcome|Placebo|Placebo arm
549995|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
549996|NCT00638027|E2|Reported Event|Placebo|Placebo arm
549997|NCT00638027|E1|Reported Event|Memantine|Memantine 10 mg bid
549998|NCT00638014|B3|Baseline|Total|Total of all reporting groups
550100|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
549999|NCT00638014|B2|Baseline|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
550000|NCT00638014|B1|Baseline|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
550001|NCT00638014|P2|Participant Flow|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
550002|NCT00638014|P1|Participant Flow|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
550003|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
550004|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
550005|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
550006|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
550007|NCT00638014|E2|Reported Event|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
550008|NCT00638014|E1|Reported Event|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
550009|NCT00637923|B3|Baseline|Total|Total of all reporting groups
550010|NCT00637923|B2|Baseline|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550011|NCT00637923|B1|Baseline|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550012|NCT00637923|P2|Participant Flow|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550013|NCT00637923|P1|Participant Flow|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550014|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550015|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550016|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550017|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550018|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550019|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550020|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550021|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550022|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550023|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550024|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550025|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550026|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550027|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550030|NCT00637923|E2|Reported Event|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550031|NCT00637923|E1|Reported Event|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
550032|NCT00637806|B4|Baseline|Total|Total of all reporting groups
550033|NCT00637806|B3|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550034|NCT00637806|B2|Baseline|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
550035|NCT00637806|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550036|NCT00637806|P4|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
550037|NCT00637806|P3|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550038|NCT00637806|P2|Participant Flow|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
550039|NCT00637806|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
550040|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550041|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
550042|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550043|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550044|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
550045|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550046|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550047|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
550048|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550049|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550050|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
550051|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550052|NCT00637806|E4|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
550053|NCT00637806|E3|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550054|NCT00637806|E2|Reported Event|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
550055|NCT00637806|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550056|NCT00637780|B1|Baseline|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550057|NCT00637780|P1|Participant Flow|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550058|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550059|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550060|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550061|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550062|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550063|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550064|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550065|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550066|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550067|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550068|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550069|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550070|NCT00637780|E1|Reported Event|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
550071|NCT00637728|B3|Baseline|Total|Total of all reporting groups
550072|NCT00637728|B2|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550073|NCT00637728|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550074|NCT00637728|P3|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
550075|NCT00637728|P2|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550076|NCT00637728|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
550077|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550078|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550079|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550080|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550081|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550082|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550083|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550084|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550085|NCT00637728|E3|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
550086|NCT00637728|E2|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
550087|NCT00637728|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
550088|NCT00637572|B3|Baseline|Total|Total of all reporting groups
550089|NCT00637572|B2|Baseline|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per as single-dose for 12 weeks
550090|NCT00637572|B1|Baseline|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per as single-dose for 12 weeks
550091|NCT00637572|P2|Participant Flow|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550092|NCT00637572|P1|Participant Flow|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550093|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550094|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550095|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550096|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550097|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550098|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550099|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550479|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550103|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550104|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550105|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550106|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550107|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550108|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550109|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550110|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550111|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550112|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550113|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
550114|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
550115|NCT00637572|E2|Reported Event|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single dose for 12 weeks
550116|NCT00637572|E1|Reported Event|Megestrol Acetate Oral Suspension NanoCrystal Dispersion|Subjects were treated with 575 mg per day as single dose for 12 weeks
550117|NCT00637494|B3|Baseline|Total|Total of all reporting groups
550118|NCT00637494|B2|Baseline|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
550119|NCT00637494|B1|Baseline|Mifepristone Followed by an Antidepressant|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
550120|NCT00637494|P2|Participant Flow|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
550121|NCT00637494|P1|Participant Flow|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
550122|NCT00637494|O2|Outcome|Placebo|"Placebo followed by an antidepressant~placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
550123|NCT00637494|O1|Outcome|Active|"Mifepristone followed by an antidepressant~mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
550124|NCT00637494|O2|Outcome|Placebo|"Placebo followed by an antidepressant~placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
550125|NCT00637494|O1|Outcome|Active|"Mifepristone followed by an antidepressant~mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
550126|NCT00637494|E2|Reported Event|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
550127|NCT00637494|E1|Reported Event|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
550128|NCT00637416|B3|Baseline|Total|Total of all reporting groups
550129|NCT00637416|B2|Baseline|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
550130|NCT00637416|B1|Baseline|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
550131|NCT00637416|P2|Participant Flow|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
550132|NCT00637416|P1|Participant Flow|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
550133|NCT00637416|O2|Outcome|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
550134|NCT00637416|O1|Outcome|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
550135|NCT00637416|E2|Reported Event|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
550136|NCT00637416|E1|Reported Event|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
550137|NCT00637377|B5|Baseline|Total|Total of all reporting groups
550138|NCT00637377|B4|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550139|NCT00637377|B3|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550140|NCT00637377|B2|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550141|NCT00637377|B1|Baseline|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550163|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550142|NCT00637377|P4|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550143|NCT00637377|P3|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550144|NCT00637377|P2|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550145|NCT00637377|P1|Participant Flow|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550146|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550147|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550148|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550149|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550150|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550151|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550152|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550153|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550154|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550155|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550156|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550157|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550158|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550159|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550160|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550161|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550162|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550791|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550164|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550165|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550166|NCT00637377|E4|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550167|NCT00637377|E3|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550168|NCT00637377|E2|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550169|NCT00637377|E1|Reported Event|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
550170|NCT00637312|B3|Baseline|Total|Total of all reporting groups
550171|NCT00637312|B2|Baseline|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
550172|NCT00637312|B1|Baseline|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
550173|NCT00637312|P2|Participant Flow|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
550174|NCT00637312|P1|Participant Flow|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
550175|NCT00637312|O2|Outcome|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
550176|NCT00637312|O1|Outcome|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
550177|NCT00637312|E2|Reported Event|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
550178|NCT00637312|E1|Reported Event|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
550179|NCT00637299|B3|Baseline|Total|Total of all reporting groups
550180|NCT00637299|B2|Baseline|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
550181|NCT00637299|B1|Baseline|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
550182|NCT00637299|P2|Participant Flow|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
550183|NCT00637299|P1|Participant Flow|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
550184|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
550185|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
550186|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
550187|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
550188|NCT00637299|E2|Reported Event|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
550189|NCT00637299|E1|Reported Event|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
550190|NCT00637273|B4|Baseline|Total|Total of all reporting groups
550191|NCT00637273|B3|Baseline|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550192|NCT00637273|B2|Baseline|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550193|NCT00637273|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550194|NCT00637273|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550195|NCT00637273|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550196|NCT00637273|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550197|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550198|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550199|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550200|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550201|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550202|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550203|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550204|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
551073|NCT00635492|E2|Reported Event|Insulin|Insulin at a dose selected by the HCP and patient
550205|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550206|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550207|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550208|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550209|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550210|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550211|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550212|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550213|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550214|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550215|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550216|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550217|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550218|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550219|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550220|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550221|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550222|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550223|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550224|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550225|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550226|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550227|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550228|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550229|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550230|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550231|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550232|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550233|NCT00637273|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550234|NCT00637273|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
550235|NCT00637273|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
550236|NCT00637247|B3|Baseline|Total|Total of all reporting groups
550237|NCT00637247|B2|Baseline|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
550238|NCT00637247|B1|Baseline|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
550239|NCT00637247|P2|Participant Flow|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
550240|NCT00637247|P1|Participant Flow|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
550241|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
550242|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
550243|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
550244|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
550245|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
550246|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
550247|NCT00637247|E2|Reported Event|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
550248|NCT00637247|E1|Reported Event|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
550249|NCT00637195|B3|Baseline|Total|Total of all reporting groups
550250|NCT00637195|B2|Baseline|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550251|NCT00637195|B1|Baseline|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550252|NCT00637195|P2|Participant Flow|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550253|NCT00637195|P1|Participant Flow|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550254|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550255|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550256|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550257|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550258|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550259|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550260|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550261|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550262|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550263|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550264|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550265|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550266|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550267|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550268|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550269|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550270|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550271|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550272|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550273|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550274|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550275|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550276|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550277|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550278|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550279|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550280|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550281|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550282|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550283|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550284|NCT00637195|E2|Reported Event|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
550285|NCT00637195|E1|Reported Event|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
550286|NCT00637156|B3|Baseline|Total|Total of all reporting groups
550287|NCT00637156|B2|Baseline|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550288|NCT00637156|B1|Baseline|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550289|NCT00637156|P2|Participant Flow|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550290|NCT00637156|P1|Participant Flow|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550480|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
550291|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550292|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550293|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550294|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550295|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550296|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550297|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550298|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550299|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550300|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550301|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550302|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550303|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550304|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550305|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550306|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550307|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550308|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550309|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550310|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550311|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550312|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550313|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550314|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550315|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550316|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
551074|NCT00635492|E1|Reported Event|Exenatide BID|Daily dose ranging from 5-20 ug
550317|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550318|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550319|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550320|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550321|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550322|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550323|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550324|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550325|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550326|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550327|NCT00637156|E2|Reported Event|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
550328|NCT00637156|E1|Reported Event|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
550329|NCT00637000|B3|Baseline|Total|Total of all reporting groups
550330|NCT00637000|B2|Baseline|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550331|NCT00637000|B1|Baseline|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550332|NCT00637000|P2|Participant Flow|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550333|NCT00637000|P1|Participant Flow|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550334|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550335|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550336|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550337|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550338|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550339|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550481|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550482|NCT00636636|E2|Reported Event|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
550340|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550341|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550342|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550343|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550344|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550345|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550346|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550347|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550348|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550349|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550350|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550351|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550352|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550353|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550354|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550355|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550356|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550357|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550358|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550359|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550483|NCT00636636|E1|Reported Event|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550360|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550361|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550362|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550363|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550364|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550365|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550366|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550367|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550368|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550369|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550370|NCT00637000|E2|Reported Event|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550371|NCT00637000|E1|Reported Event|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
550372|NCT00636987|B1|Baseline|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
550373|NCT00636987|P1|Participant Flow|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
550374|NCT00636987|O3|Outcome|Biocor Mitral Valve|
550375|NCT00636987|O2|Outcome|Biocor Supra Valve|
550376|NCT00636987|O1|Outcome|Biocor Valve|Biocor valves: Replacement for a diseased, damaged, malformed aortic heart valve
550377|NCT00636987|O1|Outcome|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
550378|NCT00636987|O1|Outcome|Implanted With Biocor, Biocor Supra, Biocor Mitral Valves|Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
550379|NCT00636987|E1|Reported Event|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
550380|NCT00636961|B3|Baseline|Total|Total of all reporting groups
550381|NCT00636961|B2|Baseline|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
550382|NCT00636961|B1|Baseline|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
550404|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550383|NCT00636961|P2|Participant Flow|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
550384|NCT00636961|P1|Participant Flow|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
550385|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550386|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550387|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550388|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550389|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550390|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550391|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550392|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550393|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550394|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550395|NCT00636961|E2|Reported Event|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550396|NCT00636961|E1|Reported Event|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
550397|NCT00636818|B1|Baseline|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550398|NCT00636818|P1|Participant Flow|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550399|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550400|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550401|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550402|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550403|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550476|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
550405|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550406|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550407|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550408|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550409|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550410|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550411|NCT00636818|E1|Reported Event|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
550412|NCT00636805|B1|Baseline|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550413|NCT00636805|P1|Participant Flow|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550414|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550415|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550416|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550417|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550418|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550419|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550420|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550421|NCT00636805|E1|Reported Event|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
550422|NCT00636792|B1|Baseline|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
550423|NCT00636792|P1|Participant Flow|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
550424|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
550425|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
550477|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550426|NCT00636792|E1|Reported Event|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
550427|NCT00636701|B3|Baseline|Total|Total of all reporting groups
550428|NCT00636701|B2|Baseline|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
550429|NCT00636701|B1|Baseline|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
550430|NCT00636701|P2|Participant Flow|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
550431|NCT00636701|P1|Participant Flow|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
550432|NCT00636701|O2|Outcome|Number of Participants Who Received Unprimed rTMS|Number of participants who received 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
550433|NCT00636701|O1|Outcome|Number of Participants Who Received Primed rTMS|Number of participants who received 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
550434|NCT00636701|E2|Reported Event|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
550435|NCT00636701|E1|Reported Event|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
550436|NCT00636649|B3|Baseline|Total|Total of all reporting groups
550437|NCT00636649|B2|Baseline|Placebo|
550438|NCT00636649|B1|Baseline|Escitalopram|
550439|NCT00636649|P2|Participant Flow|Placebo|Dosing of matching placebo was identical.
550440|NCT00636649|P1|Participant Flow|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550441|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550442|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550443|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550444|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550445|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550446|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550447|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550448|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550449|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550450|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550451|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550452|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550453|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550454|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550455|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550456|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
550457|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550458|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
550459|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550460|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
550461|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
550462|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
550463|NCT00636649|O2|Outcome|Placebo|
550464|NCT00636649|O1|Outcome|Escitalopram|
550465|NCT00636649|E2|Reported Event|Placebo|
550466|NCT00636649|E1|Reported Event|Escitalopram|
550467|NCT00636636|B3|Baseline|Total|Total of all reporting groups
550468|NCT00636636|B2|Baseline|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
550469|NCT00636636|B1|Baseline|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550470|NCT00636636|P2|Participant Flow|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
550471|NCT00636636|P1|Participant Flow|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550472|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
550473|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550474|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
550475|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
550485|NCT00636610|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550486|NCT00636610|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550487|NCT00636610|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550488|NCT00636610|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550489|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550490|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550491|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550492|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
550493|NCT00636610|E4|Reported Event|Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
550494|NCT00636610|E3|Reported Event|Placebo With FOLFIRI+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
550495|NCT00636610|E2|Reported Event|Vismodegib (GDC-0449) With FOLFOX+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
550496|NCT00636610|E1|Reported Event|Placebo With FOLFOX+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
550497|NCT00636441|B8|Baseline|Total|Total of all reporting groups
550498|NCT00636441|B7|Baseline|Screen Failure|
550499|NCT00636441|B6|Baseline|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550500|NCT00636441|B5|Baseline|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550501|NCT00636441|B4|Baseline|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550502|NCT00636441|B3|Baseline|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550503|NCT00636441|B2|Baseline|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550504|NCT00636441|B1|Baseline|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550505|NCT00636441|P7|Participant Flow|Screen Failure|
550506|NCT00636441|P6|Participant Flow|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550507|NCT00636441|P5|Participant Flow|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550508|NCT00636441|P4|Participant Flow|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550509|NCT00636441|P3|Participant Flow|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550510|NCT00636441|P2|Participant Flow|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550511|NCT00636441|P1|Participant Flow|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550512|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550513|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550514|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550515|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550516|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550517|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550518|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550519|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550520|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550521|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550522|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550523|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550524|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550525|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550526|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550527|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550528|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550529|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550530|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
550531|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
550532|NCT00636441|E7|Reported Event|Screen Failures|Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
550533|NCT00636441|E6|Reported Event|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550534|NCT00636441|E5|Reported Event|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550535|NCT00636441|E4|Reported Event|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550536|NCT00636441|E3|Reported Event|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550537|NCT00636441|E2|Reported Event|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550538|NCT00636441|E1|Reported Event|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
550539|NCT00636389|B1|Baseline|All Study Participants|
550540|NCT00636389|P2|Participant Flow|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
550541|NCT00636389|P1|Participant Flow|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
550542|NCT00636389|O2|Outcome|210H|
550543|NCT00636389|O1|Outcome|HD-C4|
550544|NCT00636389|O2|Outcome|210H|
550545|NCT00636389|O1|Outcome|HD-C4|
550546|NCT00636389|O2|Outcome|210H|
550547|NCT00636389|O1|Outcome|HD-C4|
550548|NCT00636389|E2|Reported Event|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
550549|NCT00636389|E1|Reported Event|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
550550|NCT00636363|B4|Baseline|Total|Total of all reporting groups
550551|NCT00636363|B3|Baseline|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
550552|NCT00636363|B2|Baseline|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550553|NCT00636363|B1|Baseline|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550554|NCT00636363|P3|Participant Flow|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
550555|NCT00636363|P2|Participant Flow|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550556|NCT00636363|P1|Participant Flow|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550557|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
550558|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550559|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550560|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
550561|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550562|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550563|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
550564|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550565|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550566|NCT00636363|E3|Reported Event|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
550567|NCT00636363|E2|Reported Event|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550568|NCT00636363|E1|Reported Event|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
550569|NCT00636220|B1|Baseline|Confirmed HIV Infection|participants with known (clinically or serologically) confirmed HIV infection.
550570|NCT00636220|P1|Participant Flow|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
550571|NCT00636220|O1|Outcome|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
550572|NCT00636220|E1|Reported Event|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
550573|NCT00636207|B4|Baseline|Total|Total of all reporting groups
550574|NCT00636207|B3|Baseline|Part III|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
550575|NCT00636207|B2|Baseline|Part II|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
550576|NCT00636207|B1|Baseline|Part I|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
550577|NCT00636207|P7|Participant Flow|Part III - Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
550578|NCT00636207|P6|Participant Flow|Part III - Montelukast and Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
550579|NCT00636207|P5|Participant Flow|Part III - Montelukast|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
550580|NCT00636207|P4|Participant Flow|Part II - Placebo|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
550581|NCT00636207|P3|Participant Flow|Part II - Montelukast|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
550582|NCT00636207|P2|Participant Flow|Part I - Montelukast and Placebo|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
550583|NCT00636207|P1|Participant Flow|Part I - Montelukast|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period.
550584|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
550585|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
550586|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
550587|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
550588|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
550589|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
550590|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
550591|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
550592|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
550593|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
550596|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
550597|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
550598|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
550599|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
550600|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
550601|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
550602|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
550603|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
550604|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
550605|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
550606|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
550607|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
550608|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
550609|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
550610|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
550611|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
550612|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
550613|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
550614|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
550615|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
550616|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
550617|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
550618|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
550619|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
550620|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
550621|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
550622|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
550623|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
550624|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
550625|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
550626|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
550627|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
550628|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
550629|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
550630|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
550631|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
550632|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
550633|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
550634|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
550635|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
550636|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
550637|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
550638|NCT00636207|E6|Reported Event|Placebo|Participants receiving Placebo inhalation powder
550639|NCT00636207|E5|Reported Event|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
550640|NCT00636207|E4|Reported Event|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
550641|NCT00636207|E3|Reported Event|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
550642|NCT00636207|E2|Reported Event|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
550643|NCT00636207|E1|Reported Event|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
550644|NCT00636194|B3|Baseline|Total|Total of all reporting groups
550645|NCT00636194|B2|Baseline|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
550646|NCT00636194|B1|Baseline|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
550647|NCT00636194|P2|Participant Flow|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
550648|NCT00636194|P1|Participant Flow|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
550649|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
550650|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
550651|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
550652|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
550653|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
550654|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
550655|NCT00636194|E2|Reported Event|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
550656|NCT00636194|E1|Reported Event|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
550657|NCT00636168|B3|Baseline|Total|Total of all reporting groups
550658|NCT00636168|B2|Baseline|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550659|NCT00636168|B1|Baseline|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550660|NCT00636168|P2|Participant Flow|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550661|NCT00636168|P1|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550662|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550663|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550664|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550665|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550666|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550667|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550726|NCT00635999|O3|Outcome|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
550727|NCT00635999|O2|Outcome|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
550728|NCT00635999|O1|Outcome|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
550668|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550669|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550670|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550671|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550672|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550673|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550674|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550675|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550676|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550677|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550678|NCT00636168|E2|Reported Event|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550729|NCT00635999|O3|Outcome|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
550679|NCT00636168|E1|Reported Event|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
550680|NCT00636155|B1|Baseline|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
550681|NCT00636155|P1|Participant Flow|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
550682|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
550683|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
550684|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
550685|NCT00636155|E1|Reported Event|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
550686|NCT00636077|B1|Baseline|All Study Participants|
550687|NCT00636077|P4|Participant Flow|Optiflux F200NR First|Patients in this Arm will receive 3 consecutive treatments with the F200NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
550688|NCT00636077|P3|Participant Flow|Optiflux F160NR First|Patients in this Arm will receive 3 consecutive treatments with the F160NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
550689|NCT00636077|P2|Participant Flow|HD-C4 Small First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Small dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
550690|NCT00636077|P1|Participant Flow|HD-C4 Big First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Big dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
550691|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
550692|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
550693|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
550694|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
550695|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
550696|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
550697|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
550698|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
550699|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
550700|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
550701|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
550702|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
550703|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
550704|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
550705|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
550706|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
550707|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
550708|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
550709|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
550710|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
550711|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
550712|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
550713|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
550714|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
550715|NCT00636077|E4|Reported Event|F200NR|3 consecutive treatments with the F200NR dialyzer.
550716|NCT00636077|E3|Reported Event|F160NR|3 consecutive treatments with the F160NR dialyzer.
550717|NCT00636077|E2|Reported Event|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
550718|NCT00636077|E1|Reported Event|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
550719|NCT00635999|B4|Baseline|Total|Total of all reporting groups
550720|NCT00635999|B3|Baseline|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
550721|NCT00635999|B2|Baseline|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
550722|NCT00635999|B1|Baseline|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
550723|NCT00635999|P3|Participant Flow|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
550724|NCT00635999|P2|Participant Flow|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
550725|NCT00635999|P1|Participant Flow|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
550730|NCT00635999|O2|Outcome|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
550731|NCT00635999|O1|Outcome|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
550732|NCT00635999|E3|Reported Event|Combined Cognitive Behavioral Therapy|Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy.
550733|NCT00635999|E2|Reported Event|Cognitive Therapy|Participants will receive treatment with cognitive therapy.
550734|NCT00635999|E1|Reported Event|Self-control Desensitization|Participants will receive treatment with applied relaxation and self-control desensitization.
550735|NCT00635882|B7|Baseline|Total|Total of all reporting groups
550736|NCT00635882|B6|Baseline|Placebo|Placebo MDI BID for 14 days
550737|NCT00635882|B5|Baseline|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550738|NCT00635882|B4|Baseline|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550739|NCT00635882|B3|Baseline|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550740|NCT00635882|B2|Baseline|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550741|NCT00635882|B1|Baseline|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550742|NCT00635882|P6|Participant Flow|Placebo|Placebo MDI BID for 14 days
550743|NCT00635882|P5|Participant Flow|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550744|NCT00635882|P4|Participant Flow|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550745|NCT00635882|P3|Participant Flow|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550746|NCT00635882|P2|Participant Flow|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550747|NCT00635882|P1|Participant Flow|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550748|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550749|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550750|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550751|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550752|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550753|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550754|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550755|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550756|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550757|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550758|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550759|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550760|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550761|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550762|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550763|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550764|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550765|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550766|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550767|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550768|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550769|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550770|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550771|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550772|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550773|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550774|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550775|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550776|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550777|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550778|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550779|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550780|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550781|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550782|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550783|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550784|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550785|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550786|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550787|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550788|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550789|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550790|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550792|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550793|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550794|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550795|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550796|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
550797|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
550798|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
550799|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
550800|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
550801|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
550802|NCT00635882|E6|Reported Event|PLACEBO|
550803|NCT00635882|E5|Reported Event|MF MDI 200 MCG BID|
550804|NCT00635882|E4|Reported Event|MF DPI 200 MCG BID|
550805|NCT00635882|E3|Reported Event|MF/F MDI 400/10 MCG BID|
550806|NCT00635882|E2|Reported Event|MF/F MDI 200/10 MCG BID|
550807|NCT00635882|E1|Reported Event|MF/F MDI 100/10 MCG BID|
550808|NCT00635830|B3|Baseline|Total|Total of all reporting groups
550809|NCT00635830|B2|Baseline|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550810|NCT00635830|B1|Baseline|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550811|NCT00635830|P2|Participant Flow|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550812|NCT00635830|P1|Participant Flow|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550813|NCT00635830|O2|Outcome|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550814|NCT00635830|O1|Outcome|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550815|NCT00635830|E2|Reported Event|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550816|NCT00635830|E1|Reported Event|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
550817|NCT00635817|B5|Baseline|Total|Total of all reporting groups
550818|NCT00635817|B4|Baseline|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550819|NCT00635817|B3|Baseline|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550820|NCT00635817|B2|Baseline|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550821|NCT00635817|B1|Baseline|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550822|NCT00635817|P4|Participant Flow|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550823|NCT00635817|P3|Participant Flow|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550824|NCT00635817|P2|Participant Flow|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550825|NCT00635817|P1|Participant Flow|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550826|NCT00635817|O2|Outcome|Leuprolide Acetate 30 mg|All subjects from both treatment groups who received 30 mg leuprolide acetate, both treatment naive and previously treated, were combined.
550827|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg|All subjects from both treatment groups who received 11.25 mg leuprolide acetate, both treatment naive and previously treated, were combined.
550828|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550829|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550830|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550831|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550832|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550833|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550834|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550835|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550836|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550837|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550838|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550839|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
551075|NCT00635479|B3|Baseline|Total|Total of all reporting groups
550840|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550841|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550842|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550843|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550844|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550845|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550846|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550847|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550848|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550849|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550850|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550851|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550852|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550853|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550854|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550855|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550856|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550857|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550858|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550859|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550860|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550861|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550862|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550863|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550864|NCT00635817|E4|Reported Event|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550865|NCT00635817|E3|Reported Event|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550866|NCT00635817|E2|Reported Event|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
550867|NCT00635817|E1|Reported Event|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
550868|NCT00635804|B9|Baseline|Total|Total of all reporting groups
550869|NCT00635804|B8|Baseline|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550870|NCT00635804|B7|Baseline|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550871|NCT00635804|B6|Baseline|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550872|NCT00635804|B5|Baseline|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550873|NCT00635804|B4|Baseline|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550874|NCT00635804|B3|Baseline|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550875|NCT00635804|B2|Baseline|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550876|NCT00635804|B1|Baseline|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550877|NCT00635804|P8|Participant Flow|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550878|NCT00635804|P7|Participant Flow|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
551002|NCT00635609|B1|Baseline|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
551182|NCT00635219|B6|Baseline|Total|Total of all reporting groups
550879|NCT00635804|P6|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550880|NCT00635804|P5|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550881|NCT00635804|P4|Participant Flow|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550882|NCT00635804|P3|Participant Flow|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550883|NCT00635804|P2|Participant Flow|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550884|NCT00635804|P1|Participant Flow|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550885|NCT00635804|O7|Outcome|Placebo|HCV-infected participants in Part II who received dose-matched placebo to MK-03281 orally BID for 7 consecutive days.
550886|NCT00635804|O6|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550887|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panels E+F)|GT1/GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550888|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550889|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550890|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550891|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550892|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550893|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550894|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550895|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550896|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550897|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550898|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550899|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550900|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550901|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550902|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
551003|NCT00635609|P2|Participant Flow|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
551183|NCT00635219|B5|Baseline|Duloxetine 60 mg|encapsulated capsules; orally
550903|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550904|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550905|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550906|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550907|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550908|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550909|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550910|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550911|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550912|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550913|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550914|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550915|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550916|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550917|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550918|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550919|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550920|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550921|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550922|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550923|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550924|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550925|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550926|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
551004|NCT00635609|P1|Participant Flow|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
550927|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550928|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550929|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550930|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550931|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550932|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550933|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550934|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550935|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550936|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550937|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550938|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550939|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550940|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550941|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550942|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550943|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550944|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550945|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550946|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550947|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550948|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550949|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550950|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
551005|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
550951|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550952|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550953|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550954|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550955|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550956|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550957|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550958|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550959|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550960|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550961|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550962|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550963|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550964|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550965|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550966|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550967|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550968|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550969|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550970|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550971|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550972|NCT00635804|E8|Reported Event|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
550973|NCT00635804|E7|Reported Event|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
550974|NCT00635804|E6|Reported Event|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
551006|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
550975|NCT00635804|E5|Reported Event|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
550976|NCT00635804|E4|Reported Event|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
550977|NCT00635804|E3|Reported Event|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
550978|NCT00635804|E2|Reported Event|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
550979|NCT00635804|E1|Reported Event|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
550980|NCT00635700|B3|Baseline|Total|Total of all reporting groups
550981|NCT00635700|B2|Baseline|Placebo|placebo: placebo
550982|NCT00635700|B1|Baseline|Ziprasidone|ziprasidone: 20-160 mg/d
550983|NCT00635700|P2|Participant Flow|Placebo|placebo: placebo
550984|NCT00635700|P1|Participant Flow|Ziprasidone|ziprasidone: 20-160 mg/d
550985|NCT00635700|O2|Outcome|Placebo|placebo: placebo
550986|NCT00635700|O1|Outcome|Ziprasidone|ziprasidone: 20-160 mg/d
550987|NCT00635700|E2|Reported Event|Placebo|placebo: placebo
550988|NCT00635700|E1|Reported Event|Ziprasidone|ziprasidone: 20-160 mg/d
550989|NCT00635661|B1|Baseline|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
550990|NCT00635661|P1|Participant Flow|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
550991|NCT00635661|O1|Outcome|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
550992|NCT00635661|E1|Reported Event|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
550993|NCT00635648|B1|Baseline|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
550994|NCT00635648|P1|Participant Flow|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
550995|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
550996|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
550997|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
550998|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
550999|NCT00635648|E1|Reported Event|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
551000|NCT00635609|B3|Baseline|Total|Total of all reporting groups
551001|NCT00635609|B2|Baseline|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
551007|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
551008|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
551009|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
551010|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
551011|NCT00635609|E2|Reported Event|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
551012|NCT00635609|E1|Reported Event|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
551013|NCT00635570|B3|Baseline|Total|Total of all reporting groups
551014|NCT00635570|B2|Baseline|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
551015|NCT00635570|B1|Baseline|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
551016|NCT00635570|P2|Participant Flow|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
551017|NCT00635570|P1|Participant Flow|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
551018|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
551019|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
551020|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
551021|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
551022|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
551023|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
551024|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
551025|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
551026|NCT00635570|E2|Reported Event|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
551027|NCT00635570|E1|Reported Event|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
551028|NCT00635492|B3|Baseline|Total|Total of all reporting groups
551029|NCT00635492|B2|Baseline|Insulin|Insulin at a dose selected by the HCP and patient
551030|NCT00635492|B1|Baseline|Exenatide BID|Daily dose ranging from 5-20 ug
551031|NCT00635492|P2|Participant Flow|Insulin|Insulin at a dose selected by the health care provided (HCP) and patient
551032|NCT00635492|P1|Participant Flow|Exenatide BID|Daily dose ranging from 5-20 mcg
551033|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551034|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551035|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551036|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551037|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551038|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551039|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551040|NCT00635492|O1|Outcome|Insulin Cohort|insulin at a dose selected by the HCP and patient
551041|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551042|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551043|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551044|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551045|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551046|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551047|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551048|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551049|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551050|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551051|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551052|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551053|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551054|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
551055|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551056|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551057|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551058|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551059|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551060|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551061|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551062|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551063|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551064|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551065|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551066|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551067|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551068|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551069|NCT00635492|O2|Outcome|Insulin|Insulin at a dose selected by the HCP and patient
551070|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20mcg/day
551071|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
551072|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
551076|NCT00635479|B2|Baseline|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
551077|NCT00635479|B1|Baseline|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
551078|NCT00635479|P2|Participant Flow|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
551079|NCT00635479|P1|Participant Flow|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
551080|NCT00635479|O2|Outcome|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
551081|NCT00635479|O1|Outcome|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
551082|NCT00635479|E2|Reported Event|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
551083|NCT00635479|E1|Reported Event|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
551084|NCT00635427|B6|Baseline|Total|Total of all reporting groups
551085|NCT00635427|B5|Baseline|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
551086|NCT00635427|B4|Baseline|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg) HGT-GCB-039|Imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
551087|NCT00635427|B3|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631).
551088|NCT00635427|B2|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625).
551089|NCT00635427|B1|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg)-TKT032)|VPRIV 45 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044.
551090|NCT00635427|P5|Participant Flow|VPRIV 15-60 U/kg (Parent Study VPRIV(15-60 U/kg)TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647) and continued in HGT-GCB-044 at the same dose as prescribed in TKT034
551091|NCT00635427|P4|Participant Flow|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched 60 U/kg VPRIV in HGT-GCB-044
551092|NCT00635427|P3|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
551093|NCT00635427|P2|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625)
551094|NCT00635427|P1|Participant Flow|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg) -TKT032)|VPRIV 45 U/kg, IV, every other week (EOW) for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044
551095|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
551096|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
551097|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
551098|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
551099|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
551100|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
551101|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
551102|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
551103|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
551104|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
551105|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
551106|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
551107|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
551108|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
551109|NCT00635427|O1|Outcome|VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039)|"This is the overall velaglucerase alfa group consisting of the following population:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
551110|NCT00635427|E3|Reported Event|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
551111|NCT00635427|E2|Reported Event|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
551112|NCT00635427|E1|Reported Event|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
551113|NCT00635362|B3|Baseline|Total|Total of all reporting groups
551114|NCT00635362|B2|Baseline|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551115|NCT00635362|B1|Baseline|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551116|NCT00635362|P2|Participant Flow|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551117|NCT00635362|P1|Participant Flow|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551118|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551119|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551120|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551121|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551122|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551123|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551124|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551125|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551126|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551127|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551184|NCT00635219|B4|Baseline|Vortioxetine 10 mg|encapsulated tablets; orally
551185|NCT00635219|B3|Baseline|Vortioxetine 5 mg|encapsulated tablets; orally
551128|NCT00635362|E2|Reported Event|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
551129|NCT00635362|E1|Reported Event|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
551130|NCT00635349|B3|Baseline|Total|Total of all reporting groups
551131|NCT00635349|B2|Baseline|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551132|NCT00635349|B1|Baseline|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551133|NCT00635349|P2|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551134|NCT00635349|P1|Participant Flow|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551135|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551136|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551137|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551138|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551139|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551140|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551141|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551186|NCT00635219|B2|Baseline|Vortioxetine 2.5 mg|encapsulated tablets; orally
551187|NCT00635219|B1|Baseline|Placebo|capsules; daily; orally
551188|NCT00635219|P5|Participant Flow|Duloxetine 60 mg|encapsulated capsules; orally
551189|NCT00635219|P4|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; orally
551142|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551143|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551144|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551145|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551146|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551147|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551148|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551149|NCT00635349|E2|Reported Event|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
551150|NCT00635349|E1|Reported Event|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
551151|NCT00635232|B6|Baseline|Total|Total of all reporting groups
551152|NCT00635232|B5|Baseline|PS433540 800mg|PS433540 800mg once daily
551153|NCT00635232|B4|Baseline|PS433540 400mg|PS433540 400mg once daily
551154|NCT00635232|B3|Baseline|PS433540 200mg|PS433540 200mg once daily
551155|NCT00635232|B2|Baseline|Placebo|Blinded Placebo Treatment
551156|NCT00635232|B1|Baseline|Irbesartan 300mg|Irbesartan 300 mg once daily
551157|NCT00635232|P5|Participant Flow|PS433540 800mg|PS433540 800mg once daily
551158|NCT00635232|P4|Participant Flow|PS433540 400mg|PS433540 400mg once daily
551159|NCT00635232|P3|Participant Flow|PS433540 200mg|PS433540 200mg once daily
551160|NCT00635232|P2|Participant Flow|Placebo|Blinded Placebo Treatment
551161|NCT00635232|P1|Participant Flow|Irbesartan 300mg|Irbesartan 300 mg once daily
551162|NCT00635232|O5|Outcome|PS433540 800mg|
551163|NCT00635232|O4|Outcome|PS433540 400mg|
551164|NCT00635232|O3|Outcome|PS433540 200mg|
551165|NCT00635232|O2|Outcome|Placebo|
551166|NCT00635232|O1|Outcome|Irbesartan 300mg|
551167|NCT00635232|O5|Outcome|PS433540 800mg|
551168|NCT00635232|O4|Outcome|PS433540 400mg|
551169|NCT00635232|O3|Outcome|PS433540 200mg|
551170|NCT00635232|O2|Outcome|Placebo|
551171|NCT00635232|O1|Outcome|Irbesartan 300mg|
551172|NCT00635232|O5|Outcome|PS433540 800mg|
551173|NCT00635232|O4|Outcome|PS433540 400mg|
551174|NCT00635232|O3|Outcome|PS433540 200mg|
551175|NCT00635232|O2|Outcome|Placebo|
551176|NCT00635232|O1|Outcome|Irbesartan 300mg|
551177|NCT00635232|E5|Reported Event|PS433540 800mg|PS433540 800mg once daily
551178|NCT00635232|E4|Reported Event|PS433540 400mg|PS433540 400mg once daily
551179|NCT00635232|E3|Reported Event|PS433540 200mg|PS433540 200mg once daily
551180|NCT00635232|E2|Reported Event|Placebo|Blinded Placebo Treatment
551181|NCT00635232|E1|Reported Event|Irbesartan 300mg|Irbesartan 300 mg once daily
551190|NCT00635219|P3|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; orally
551191|NCT00635219|P2|Participant Flow|Vortioxetine 2.5 mg|encapsulated tablets; orally
551192|NCT00635219|P1|Participant Flow|Placebo|capsules; daily; orally
551193|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551194|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551195|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551196|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551197|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551198|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551199|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551200|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551201|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551202|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551203|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551204|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551205|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551206|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551207|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551208|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551209|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551210|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551211|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551212|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551213|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551214|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551215|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551216|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551217|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551218|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551219|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551220|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551221|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551222|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551223|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551224|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551225|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551226|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551227|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551228|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551229|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551230|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551231|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551232|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551233|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551234|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551235|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551236|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551237|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551238|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
551239|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
551240|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
551241|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
551242|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
551243|NCT00635219|E5|Reported Event|Duloxetine 60 mg|
551244|NCT00635219|E4|Reported Event|Vortioxetine 10 mg|
551245|NCT00635219|E3|Reported Event|Vortioxetine 5 mg|
551246|NCT00635219|E2|Reported Event|Vortioxetine 2.5 mg|
551247|NCT00635219|E1|Reported Event|Placebo|
551248|NCT00635154|B1|Baseline|Anakinra With/Without Dexamethasone|
551249|NCT00635154|P1|Participant Flow|Anakinra With/Without Dexamethasone|
551250|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
551251|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
551252|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
551253|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
551254|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
551255|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
551256|NCT00635154|O1|Outcome|Anakinra Without Dexamethasone|Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).
551257|NCT00635154|E1|Reported Event|Anakinra With/Without Dexamethasone|
551258|NCT00635128|B3|Baseline|Total|Total of all reporting groups
551259|NCT00635128|B2|Baseline|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551994|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551260|NCT00635128|B1|Baseline|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551261|NCT00635128|P2|Participant Flow|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551262|NCT00635128|P1|Participant Flow|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551263|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551264|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551265|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551266|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551267|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551268|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551269|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551270|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551271|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551272|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551273|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551274|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551275|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551276|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551277|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551278|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551300|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551279|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551280|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551281|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551282|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551283|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551284|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551285|NCT00635128|O2|Outcome|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551286|NCT00635128|O1|Outcome|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551287|NCT00635128|E2|Reported Event|Boostrix + IPV Mérieux Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551288|NCT00635128|E1|Reported Event|Boostrix-Polio Group|Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
551289|NCT00635102|B3|Baseline|Total|Total of all reporting groups
551290|NCT00635102|B2|Baseline|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551291|NCT00635102|B1|Baseline|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551292|NCT00635102|P2|Participant Flow|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the structured clinical interview (SCID).
551293|NCT00635102|P1|Participant Flow|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet Diagnostic and Statistical manual (DSM) IV criteria for alcohol dependence by structured clinical interview
551294|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551295|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551296|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551297|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551298|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551299|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551301|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551302|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551303|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551304|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551305|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551306|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551307|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551308|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551309|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551310|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551311|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551312|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551313|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551314|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551315|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551316|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551317|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551318|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551319|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551320|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551321|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551388|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551322|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551323|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551324|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551325|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551326|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551327|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551328|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551329|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551330|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551331|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551332|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551333|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551334|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551335|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551336|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551337|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551338|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551339|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551340|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551341|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551342|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551390|NCT00635089|O3|Outcome|Open-Label Reslizumab: 3 mg/kg|Open-label reslizumab IV infusion at 3 mg/kg monthly
551343|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551344|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551345|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551346|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551347|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551348|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551349|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551350|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551351|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551352|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551353|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551354|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551355|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551356|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551357|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551358|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551359|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551360|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551361|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551362|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551363|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551389|NCT00635089|O4|Outcome|Open-Label Reslizumab: Overall|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly, continued at 1 to 3 mg/kg monthly
551364|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551365|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551366|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551367|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551368|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551369|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551370|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551371|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551372|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551373|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551374|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551375|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551376|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551377|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551378|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551379|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551380|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551381|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551382|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
551383|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
551384|NCT00635102|E2|Reported Event|Healthy Subjects|
551385|NCT00635102|E1|Reported Event|Alcoholic Subjects|
551386|NCT00635089|B1|Baseline|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551387|NCT00635089|P1|Participant Flow|Open-Label Reslizumab|Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
551391|NCT00635089|O2|Outcome|Open-Label Reslizumab: 2 mg/kg|Open-label reslizumab IV infusion at 2 mg/kg monthly
551392|NCT00635089|O1|Outcome|Open-Label Reslizumab: 1 mg/kg|Open-label reslizumab IV infusion at 1 mg/kg monthly
551393|NCT00635089|O4|Outcome|Changed by Eating Foods That Previously Worsened EoE|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by eating foods that previously worsened EoE.
551394|NCT00635089|O3|Outcome|Changed by Increasing Consistency of Food|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by increasing the consistency of their food.
551395|NCT00635089|O2|Outcome|Changed Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434).
551396|NCT00635089|O1|Outcome|Maintained Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who maintained their diet from the beginning of the double-blind study (NCT00538434).
551397|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551398|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551399|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551400|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551401|NCT00635089|O5|Outcome|Grade 4|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 4.
551402|NCT00635089|O4|Outcome|Grade 3|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 3.
551403|NCT00635089|O3|Outcome|Grade 2|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 2.
551404|NCT00635089|O2|Outcome|Grade 1|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 1.
551405|NCT00635089|O1|Outcome|Grade 0|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 0.
551406|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551407|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551408|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551409|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551410|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551411|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551412|NCT00635089|E1|Reported Event|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
551413|NCT00635050|B1|Baseline|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
551414|NCT00635050|P1|Participant Flow|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
551415|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
551416|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin:~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
551924|NCT00634010|E1|Reported Event|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
551417|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
551418|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
551419|NCT00635050|E1|Reported Event|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
551420|NCT00635024|B1|Baseline|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551421|NCT00635024|P1|Participant Flow|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551422|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551423|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551424|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551425|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551426|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551427|NCT00635024|E1|Reported Event|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
551428|NCT00634933|B4|Baseline|Total|Total of all reporting groups
551429|NCT00634933|B3|Baseline|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551430|NCT00634933|B2|Baseline|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551431|NCT00634933|B1|Baseline|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551432|NCT00634933|P5|Participant Flow|Placebo/TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
551433|NCT00634933|P4|Participant Flow|Placebo/TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551669|NCT00634504|O2|Outcome|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
551434|NCT00634933|P3|Participant Flow|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551435|NCT00634933|P2|Participant Flow|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551436|NCT00634933|P1|Participant Flow|Placebo|Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
551437|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551438|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551439|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551440|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551441|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551502|NCT00634920|B3|Baseline|Not Randomized Patients|This group included patients in whom a renal TX was performed but who did not qualify for randomization at Visit 2. This group was to be described with respect to treatment, reason for not randomized and outcome variables calculated or measured GFR, whichever was feasible, BPAR, graft loss or death at 12 months (no outcome variables were collected for this population
551670|NCT00634504|O1|Outcome|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
551442|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551443|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551444|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551445|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551446|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551447|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551448|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551449|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551671|NCT00634504|E2|Reported Event|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
551925|NCT00633984|B3|Baseline|Total|Total of all reporting groups
551450|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551451|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551452|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551453|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551454|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551455|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551456|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551457|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551672|NCT00634504|E1|Reported Event|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
551673|NCT00634322|B4|Baseline|Total|Total of all reporting groups
551458|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551459|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551460|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551461|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551462|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551463|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551464|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551465|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551646|NCT00634543|B2|Baseline|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551466|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551467|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551468|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551469|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551470|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551471|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551472|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551473|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551674|NCT00634322|B3|Baseline|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
551995|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551474|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551475|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551476|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551477|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551478|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551479|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551480|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551481|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551675|NCT00634322|B2|Baseline|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
551482|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551483|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551484|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551485|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551486|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551487|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551488|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551489|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551647|NCT00634543|B1|Baseline|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551490|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551491|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551492|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551493|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
551494|NCT00634933|E7|Reported Event|Placebo/TRU-015 Induction Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
551495|NCT00634933|E6|Reported Event|Placebo/TRU-015 Single Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551496|NCT00634933|E5|Reported Event|TRU-015 Induction Dose (Part B)|Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551497|NCT00634933|E4|Reported Event|TRU-015 Single Dose (Part B)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
551498|NCT00634933|E3|Reported Event|TRU-015 Induction Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.
551499|NCT00634933|E2|Reported Event|TRU-015 Single Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.
551500|NCT00634933|E1|Reported Event|Placebo (Part A)|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
551501|NCT00634920|B4|Baseline|Total|Total of all reporting groups
551676|NCT00634322|B1|Baseline|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
551503|NCT00634920|B2|Baseline|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551504|NCT00634920|B1|Baseline|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551505|NCT00634920|P3|Participant Flow|Pre-Randomized Patients|All patients received induction therapy with 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg at Day 4 post-TX (transplatation), and commenced on an immunosuppressive regimen consisting of: CsA (based on trough levels C0-h 100-250 ng/mL or C2-h 900 1300 ng/mL, according to local method), EC MPS (target dose 1440 mg/day, minimum dose 1080 mg/day at the time of randomization), Corticosteroids (a minimum dose of 10 mg prednisolone or equivalent was given at time of randomization).
551506|NCT00634920|P2|Participant Flow|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551507|NCT00634920|P1|Participant Flow|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551508|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551509|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551510|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551511|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551512|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551513|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551514|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551515|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551516|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551677|NCT00634322|P3|Participant Flow|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
551517|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551518|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551519|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551520|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551521|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551522|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551523|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551524|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551525|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551526|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551527|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551528|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551529|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551530|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551678|NCT00634322|P2|Participant Flow|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
551531|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551532|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551533|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551534|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551535|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551536|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551537|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551538|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551539|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551540|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551541|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551542|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551543|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551544|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551679|NCT00634322|P1|Participant Flow|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
551545|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551546|NCT00634920|E2|Reported Event|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
551547|NCT00634920|E1|Reported Event|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
551548|NCT00634907|B3|Baseline|Total|Total of all reporting groups
551549|NCT00634907|B2|Baseline|Control Arm|Standard of care dosing
551550|NCT00634907|B1|Baseline|Genotype-Based Dosing Arm|Initial warfarin dose calculated according to published Sconce algorithm
551551|NCT00634907|P2|Participant Flow|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551552|NCT00634907|P1|Participant Flow|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551553|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551554|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551555|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551556|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551557|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551648|NCT00634543|P2|Participant Flow|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551558|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551559|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551560|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551561|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551562|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551563|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551564|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551565|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551566|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551567|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551668|NCT00634504|P1|Participant Flow|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
551568|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551569|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551570|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551571|NCT00634907|E2|Reported Event|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
551572|NCT00634907|E1|Reported Event|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
551573|NCT00634842|B3|Baseline|Total|Total of all reporting groups
551574|NCT00634842|B2|Baseline|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
551575|NCT00634842|B1|Baseline|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
551576|NCT00634842|P2|Participant Flow|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
551577|NCT00634842|P1|Participant Flow|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
551578|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
551579|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
551580|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
551581|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
551582|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
551583|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
551584|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
551585|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
551586|NCT00634842|E2|Reported Event|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
551587|NCT00634842|E1|Reported Event|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
551588|NCT00634751|B5|Baseline|Total|Total of all reporting groups
551589|NCT00634751|B4|Baseline|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
551590|NCT00634751|B3|Baseline|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
551718|NCT00634244|B1|Baseline|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
551591|NCT00634751|B2|Baseline|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
551592|NCT00634751|B1|Baseline|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
551593|NCT00634751|P4|Participant Flow|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
551594|NCT00634751|P3|Participant Flow|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily."
551595|NCT00634751|P2|Participant Flow|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
551596|NCT00634751|P1|Participant Flow|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
551597|NCT00634751|O4|Outcome|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551598|NCT00634751|O3|Outcome|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551599|NCT00634751|O2|Outcome|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
551600|NCT00634751|O1|Outcome|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
551601|NCT00634751|O4|Outcome|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551602|NCT00634751|O3|Outcome|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551603|NCT00634751|O2|Outcome|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
551604|NCT00634751|O1|Outcome|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
551605|NCT00634751|O4|Outcome|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551606|NCT00634751|O3|Outcome|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551607|NCT00634751|O2|Outcome|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
551608|NCT00634751|O1|Outcome|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
551926|NCT00633984|B2|Baseline|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
551609|NCT00634751|E4|Reported Event|Phase II: Biliary Tract Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551610|NCT00634751|E3|Reported Event|Phase II: Pancreatic Cancer|"Oxaliplatin + Oral Capecitabine + Sorafeni~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle."
551611|NCT00634751|E2|Reported Event|Phase I: 400mg Sorafenib BID+2DOC|"Cohort 2: 400mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 400 mg of sorafenib orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length~Sorafenib 400 mg BID Oral Daily Every 28 days"
551612|NCT00634751|E1|Reported Event|Phase I: 200mg Sorafenib+2DOC|"Cohort 1: 200mg Sorafenib+2DOC~Oxaliplatin + Oral Capecitabine + Sorafenib~Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.~Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.~Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.~Cohort I~Sorafenib 200 mg BID Oral Daily Every 28 days~If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd."
551613|NCT00634647|B1|Baseline|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
551614|NCT00634647|P1|Participant Flow|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
551615|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
551616|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
551617|NCT00634647|E1|Reported Event|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
551618|NCT00634621|B1|Baseline|Hexvix|Use of the Hexvix drug.
551619|NCT00634621|P1|Participant Flow|Hexvix 2 mg/mL Infusion|Administrtation of 2 mg/mL Hexvix.
551620|NCT00634621|O1|Outcome|Confirmed Bladder Cancer by Standard of Truth|Using the Hexvix drug with a cystoscopy technique of White-light cystoscopy and Blue-light cystoscopy.
551621|NCT00634621|O4|Outcome|Multiple Normalized Biopsy|Only Multiple Normalized Biopsy.
551622|NCT00634621|O3|Outcome|Blue-light Cystoscopy Only|Hexvix administered using only Blue-light Cystoscopy.
551623|NCT00634621|O2|Outcome|White-light Cystoscopy Only|Hexvix administered using only White-light Cystoscopy.
551624|NCT00634621|O1|Outcome|White-light and Blue-Light Cystoscopy Simultaneously|Hexvix administered using both White-light and Blue-Light Cystoscopy.
551625|NCT00634621|E1|Reported Event|Hexvix|Use of the Hexvix drug.
551626|NCT00634582|B1|Baseline|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
551627|NCT00634582|P1|Participant Flow|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
551628|NCT00634582|O1|Outcome|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
551629|NCT00634582|E1|Reported Event|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
551630|NCT00634569|B3|Baseline|Total|Total of all reporting groups
551631|NCT00634569|B2|Baseline|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
551632|NCT00634569|B1|Baseline|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
551633|NCT00634569|P2|Participant Flow|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
551634|NCT00634569|P1|Participant Flow|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
551635|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
551636|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
551637|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
551638|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
551639|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
551640|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
551641|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
551642|NCT00634569|O2|Outcome|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
551643|NCT00634569|O1|Outcome|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
551644|NCT00634569|E1|Reported Event|All Subjects|Intent-to-treat population
551645|NCT00634543|B3|Baseline|Total|Total of all reporting groups
551649|NCT00634543|P1|Participant Flow|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551650|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551651|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551652|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551653|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551654|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551655|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551656|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551657|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551658|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551659|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551660|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551661|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551662|NCT00634543|E2|Reported Event|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551663|NCT00634543|E1|Reported Event|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
551664|NCT00634504|B3|Baseline|Total|Total of all reporting groups
551665|NCT00634504|B2|Baseline|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
551666|NCT00634504|B1|Baseline|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
551667|NCT00634504|P2|Participant Flow|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
551680|NCT00634322|O3|Outcome|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
551681|NCT00634322|O2|Outcome|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
551682|NCT00634322|O1|Outcome|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
551683|NCT00634322|E3|Reported Event|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
551684|NCT00634322|E2|Reported Event|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
551685|NCT00634322|E1|Reported Event|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
551686|NCT00634270|B3|Baseline|Total|Total of all reporting groups
551687|NCT00634270|B2|Baseline|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551688|NCT00634270|B1|Baseline|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551689|NCT00634270|P2|Participant Flow|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551690|NCT00634270|P1|Participant Flow|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551691|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551692|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551693|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551694|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551695|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551696|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551697|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551698|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551699|NCT00634270|O2|Outcome|Stratum 2|Patients ≥ 3 years old and plexiform neurofibroma(s) without documented radiographic progression at trial entry. The endpoint will be radiographic response.
551700|NCT00634270|O1|Outcome|Stratum 1|Patients ≥ 3 years old with progressive plexiform neurofibroma(s) with the potential to cause significant morbidity.
551920|NCT00634010|P1|Participant Flow|Morphine Capsule|Morphine 5 mg slow release morphine orally every 12 hours and 5 mg immediate-release morphine every 2 hours as needed for breakthrough pain.
551701|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551702|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
551703|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
551704|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
551705|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
551706|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551707|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing."
551708|NCT00634270|O2|Outcome|Stratum 2|Patients ≥ 3 years old and plexiform neurofibroma(s) without documented radiographic progression at trial entry. The endpoint will be radiographic response.
551709|NCT00634270|O1|Outcome|Stratum 1|Patients ≥ 3 years old with progressive plexiform neurofibroma(s) with the potential to cause significant morbidity.
551710|NCT00634270|O1|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551711|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551712|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
551713|NCT00634270|E2|Reported Event|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
551714|NCT00634270|E1|Reported Event|Stratum 1|"Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity with evidence of progression.~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Disease status will be evaluated using volumetric MRI analysis at regular intervals."
551715|NCT00634244|B4|Baseline|Total|Total of all reporting groups
551716|NCT00634244|B3|Baseline|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
551717|NCT00634244|B2|Baseline|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
551719|NCT00634244|P3|Participant Flow|Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)|"Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV~sirolimus: Given PO~etoposide: Given IV"
551720|NCT00634244|P2|Participant Flow|Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)|"Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
551721|NCT00634244|P1|Participant Flow|Arm A (Carboplatin and Topotecan Hydrochloride)|"Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.~carboplatin: Given IV~topotecan hydrochloride: Given IV"
551722|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
551723|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
551724|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
551725|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
551726|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
551727|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
551728|NCT00634244|E3|Reported Event|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
551729|NCT00634244|E2|Reported Event|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
551730|NCT00634244|E1|Reported Event|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
551731|NCT00634179|B1|Baseline|Treatment (VR-CHOP Regimen)|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity."
551732|NCT00634179|P1|Participant Flow|Treatment (VR-CHOP Regimen)|"Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy regimen.~In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-cell non-Hodgkin's lymphoma (B-NHL)(Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma."
551733|NCT00634179|O2|Outcome|Phase II: Maintenance|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving CR receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or PR receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bortezomib: Bortezomib 1.6 mg/m² given on days 1 and 8~Rituximab: Rituximab 375 mg/m²~Doxorubicin: Doxorubicin 50 mg/m²~Cyclophosphamide: Cyclophosphamide 750 mg/m²~Vincristine: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1~Prednisone: Prednisone 100 mg/day given orally on"
551734|NCT00634179|O1|Outcome|Phase I: Induction|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
551735|NCT00634179|O1|Outcome|MTD of Bortezomib With Vincristine Capped at 1.5 mg|Maximal tolerated dose (MTD) of bortezomib when vincristine is capped at 1.5 mg
551736|NCT00634179|E2|Reported Event|Phase II: Maintenance|In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-NHL. (Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.
551737|NCT00634179|E1|Reported Event|Phase I: Induction|Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the CHOP chemotherapy regimen.
551738|NCT00634166|B3|Baseline|Total|Total of all reporting groups
551739|NCT00634166|B2|Baseline|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551921|NCT00634010|O2|Outcome|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
551740|NCT00634166|B1|Baseline|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551741|NCT00634166|P2|Participant Flow|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551742|NCT00634166|P1|Participant Flow|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551743|NCT00634166|O2|Outcome|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551744|NCT00634166|O1|Outcome|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551745|NCT00634166|E2|Reported Event|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551746|NCT00634166|E1|Reported Event|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
551747|NCT00634114|B4|Baseline|Total|Total of all reporting groups
551748|NCT00634114|B3|Baseline|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
551749|NCT00634114|B2|Baseline|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
551750|NCT00634114|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
551751|NCT00634114|P3|Participant Flow|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
551752|NCT00634114|P2|Participant Flow|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
551753|NCT00634114|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
551754|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
551755|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
551756|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
551757|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
551758|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
551759|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
551760|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
551761|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
551762|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
551763|NCT00634114|E3|Reported Event|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
551764|NCT00634114|E2|Reported Event|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
551765|NCT00634114|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
551766|NCT00634088|B5|Baseline|Total|Total of all reporting groups
551767|NCT00634088|B4|Baseline|Ixabepilone + Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
551768|NCT00634088|B3|Baseline|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg), lapatinib 1250 mg administered orally once a day, every day for 7 to 14 consecutive days prior to the first administration of ixabepilone in Cycle 1. Then lapatinib administered daily, orally once a day, for a 21-day cycle. Ixabepilone administered as a 3-hour IV infusion of 40 mg/m^2 following lapatinib lead-in period.
551804|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551992|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551769|NCT00634088|B2|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg), lapatinib 1250 mg administered orally once a day, every day, for 7 to 14 consecutive days prior to the first administration of ixabepilone. Then lapatinib administered orally once a day, every day, for a 21-day cycle. After lapatinib lead-in period, ixabepilone administered as a 3-hour IV infusion of 32 mg/m^2.
551770|NCT00634088|B1|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib administered daily in escalating cohorts, beginning with 1000 mg, orally once a day, for 7 to 14 consecutive days in Cycle 1 prior to the first administration of ixabepilone. Then lapatinib administered daily, orally once a day, for a 21-day cycle. After the lapatinib lead-in phase, ixabepilone administered as a 3-hour IV infusion in escalating doses, beginning with 32 mg/m^2.
551771|NCT00634088|P4|Participant Flow|Ixabepilone+ Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
551772|NCT00634088|P3|Participant Flow|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
551773|NCT00634088|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
551774|NCT00634088|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
551775|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551776|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551777|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551778|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551779|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551780|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551781|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551782|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551783|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
551784|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551785|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551786|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551787|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551788|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551789|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551790|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551791|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551792|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551793|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551794|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551795|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551796|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551797|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551798|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551799|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551800|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551801|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551802|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551803|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551993|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551805|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551806|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551807|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551808|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551809|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551810|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551811|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551812|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551813|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551814|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551815|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551816|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
551817|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551818|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
551819|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
551820|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
551821|NCT00634088|E3|Reported Event|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
551922|NCT00634010|O1|Outcome|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
551923|NCT00634010|E2|Reported Event|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
551822|NCT00634088|E2|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
551823|NCT00634088|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for 21-day cycle.
551824|NCT00634049|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
551825|NCT00634049|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
551826|NCT00634049|O1|Outcome|Isavuconazole|Participants received Isavuconazole intravenous (IV) or per oral (PO) over period of 2 days, on days 1 and 2 three doses of 200 mg were administered every 8 hours for a total of six doses. From Day 3 to End of Treatment (EOT) maintenance dose of 200 mg isavuconazole was administered once daily up to 180 days; with an option for extended treatment under specified criteria.
551827|NCT00634049|O2|Outcome|Not Renally Impaired|Not Renally Impaired (NRI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551828|NCT00634049|O1|Outcome|Renally Impaired|Renally Impaired (RI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. Renal impairment was defined as yes for participants who had a baseline eGFR-MDRD < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551829|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
551830|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
551831|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
551832|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
551833|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
551834|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
551835|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
551836|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
551837|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551855|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
551838|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551839|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
551840|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
551841|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
551842|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
551843|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
551844|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
551845|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
551846|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
551847|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551848|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551849|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
551850|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
551851|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
551852|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
551853|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
551854|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
551915|NCT00634036|E1|Reported Event|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
551916|NCT00634010|B3|Baseline|Total|Total of all reporting groups
551856|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
551857|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551858|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551859|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
551860|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other Non Candida Yeast mITT population consisted of 11 participants who have had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus NOS and 2 Trichosporon).
551861|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who have had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes,9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
551862|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
551863|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who have had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium,2 Exophiala,2 Cladosporium,2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia,Exserohilum, Paecilomyces,Pseudallescheria and Scedosporium).
551864|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales – Intolerant mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
551865|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales – Refractory Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
551866|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales – Primary Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
551867|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Overall there were 24 participants in the mITTAspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551868|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551869|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
551870|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
551871|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
551872|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
551873|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
551874|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
551875|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
551876|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
551877|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551878|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551879|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
551880|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
551881|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
551882|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
551883|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
551884|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
551885|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
551886|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
551887|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551917|NCT00634010|B2|Baseline|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
551918|NCT00634010|B1|Baseline|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
551919|NCT00634010|P2|Participant Flow|Methadone Capsule|Methadone 5 mg orally every 12 hours and 5 mg immediate-release (IR) Morphine every 2 hours as needed for rescue pain (for first week).
551888|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired or not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551889|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
551890|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
551891|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
551892|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
551893|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
551894|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
551895|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
551896|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
551897|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
551898|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
551899|NCT00634049|E2|Reported Event|Not Renally Impaired (NRI)|"Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD~≥ 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula."
551900|NCT00634049|E1|Reported Event|Renally Impaired (RI)|Renal impairment was defined as yes for participants who have a baseline as eGFR < 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula.
551901|NCT00634036|B3|Baseline|Total|Total of all reporting groups
551902|NCT00634036|B2|Baseline|Placebo|placebo: matching placebo (inert tablet)
551903|NCT00634036|B1|Baseline|Pioglitazone|pioglitazone: pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
551904|NCT00634036|P2|Participant Flow|Placebo|matching placebo (inert tablet)
551905|NCT00634036|P1|Participant Flow|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
551906|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
551907|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
551908|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
551909|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
551910|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
551911|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
551912|NCT00634036|O2|Outcome|Placebo|matching placebo (inert tablet)
551913|NCT00634036|O1|Outcome|Pioglitazone|pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
551914|NCT00634036|E2|Reported Event|Placebo|matching placebo (inert tablet)
551927|NCT00633984|B1|Baseline|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
551928|NCT00633984|P2|Participant Flow|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
551929|NCT00633984|P1|Participant Flow|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
551930|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
551931|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
551932|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
551933|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
551934|NCT00633984|E2|Reported Event|Cognitive Behavioral Therapy + Placebo|Participants received Cognitive Behavioral Group Therapy and Placebo.
551935|NCT00633984|E1|Reported Event|Cognitive Behavioral Therapy + DCS|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
551936|NCT00633932|B4|Baseline|Total|Total of all reporting groups
551937|NCT00633932|B3|Baseline|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
551938|NCT00633932|B2|Baseline|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
551939|NCT00633932|B1|Baseline|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
551940|NCT00633932|P3|Participant Flow|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
551941|NCT00633932|P2|Participant Flow|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
551942|NCT00633932|P1|Participant Flow|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
551943|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
551944|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
551945|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
551946|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
551947|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
551948|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
551949|NCT00633932|E3|Reported Event|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
551950|NCT00633932|E2|Reported Event|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
551951|NCT00633932|E1|Reported Event|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
551952|NCT00633919|B3|Baseline|Total|Total of all reporting groups
551953|NCT00633919|B2|Baseline|Placebo|SLITone Placebo
551954|NCT00633919|B1|Baseline|Active|SLITone Dermatophagoides Mix
551955|NCT00633919|P2|Participant Flow|Placebo|SLITone Placebo
551956|NCT00633919|P1|Participant Flow|Active|SLITone Dermatophagoides Mix
551957|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
551958|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
551959|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
551960|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
551961|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
551962|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
551963|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
551964|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
551965|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
551966|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
551967|NCT00633919|E2|Reported Event|Placebo|SLITone Placebo
551968|NCT00633919|E1|Reported Event|Active|SLITone Dermatophagoides Mix
551969|NCT00633893|B4|Baseline|Total|Total of all reporting groups
551970|NCT00633893|B3|Baseline|Placebo|Participants received matching placebo oral tablet BID.
551971|NCT00633893|B2|Baseline|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551972|NCT00633893|B1|Baseline|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551973|NCT00633893|P3|Participant Flow|Placebo|Participants received matching placebo oral tablet BID.
551974|NCT00633893|P2|Participant Flow|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551975|NCT00633893|P1|Participant Flow|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban twice a day (BID)
551976|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551977|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551978|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551979|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551980|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551981|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551982|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551983|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551984|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551985|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551986|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551987|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551988|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551989|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551990|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551991|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551996|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
551997|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
551998|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
551999|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552000|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552001|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552002|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552003|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552004|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552005|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552006|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552007|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552008|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552009|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552010|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552011|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552012|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552013|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552014|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552015|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552016|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552017|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552018|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552019|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552020|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552021|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552022|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552023|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552024|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552025|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552026|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552027|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552028|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552029|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552030|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552031|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552032|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552033|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552034|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552035|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552036|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552037|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552038|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552039|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
552040|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
552041|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
552042|NCT00633893|E3|Reported Event|Placebo|Participants received oral tablet of placebo BID
552043|NCT00633893|E2|Reported Event|Apixaban 5mg|Participants received 5 mg oral tablet apixaban BID
552044|NCT00633893|E1|Reported Event|Apixaban 2.5mg|Participants received 2.5 mg oral tablet apixaban BID
552045|NCT00633880|B4|Baseline|Total|Total of all reporting groups
552046|NCT00633880|B3|Baseline|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552047|NCT00633880|B2|Baseline|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552048|NCT00633880|B1|Baseline|Not Randomized|Entered open-label droxidopa dose titration, but did not randomize
552049|NCT00633880|P3|Participant Flow|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552050|NCT00633880|P2|Participant Flow|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552051|NCT00633880|P1|Participant Flow|Open Label Titration|All patients titrated to their optimal dose of droxidopa during an initial open label phase for 7-14 days
552052|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552053|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552054|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552055|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552056|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552057|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552058|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552059|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552060|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552061|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552062|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552063|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552064|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552065|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552066|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552067|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552068|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552069|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552070|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552071|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552072|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552073|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552074|NCT00633880|E3|Reported Event|Open Label Phase|All patient titrated on droxidopa during open-label phase
552075|NCT00633880|E2|Reported Event|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552076|NCT00633880|E1|Reported Event|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
552077|NCT00633867|B3|Baseline|Total|Total of all reporting groups
552078|NCT00633867|B2|Baseline|Macintosh|Tracheal intubation using Macintosh Laryngoscope
552079|NCT00633867|B1|Baseline|McGrath|Tracheal Intubation using McGrath video-laryngoscope
552080|NCT00633867|P2|Participant Flow|Macintosh|Tracheal intubation using Macintosh Laryngoscope
552081|NCT00633867|P1|Participant Flow|McGrath|Tracheal Intubation using McGrath video-laryngoscope
552082|NCT00633867|O2|Outcome|Macintosh|Tracheal intubation using Macintosh Laryngoscope
552083|NCT00633867|O1|Outcome|McGrath|Tracheal Intubation using McGrath video-laryngoscope
552084|NCT00633867|E2|Reported Event|Macintosh|Tracheal intubation using Macintosh Laryngoscope
552085|NCT00633867|E1|Reported Event|McGrath|Tracheal Intubation using McGrath video-laryngoscope
552086|NCT00633750|B1|Baseline|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
552087|NCT00633750|P1|Participant Flow|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
552088|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants have their blood drawn and then undergo surgical resection of their tumor.
552089|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
552090|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
552091|NCT00633750|E1|Reported Event|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
552092|NCT00633594|B4|Baseline|Total|Total of all reporting groups
552093|NCT00633594|B3|Baseline|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
552094|NCT00633594|B2|Baseline|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
552095|NCT00633594|B1|Baseline|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. .
552096|NCT00633594|P3|Participant Flow|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
552097|NCT00633594|P2|Participant Flow|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
552098|NCT00633594|P1|Participant Flow|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14.
552099|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
552100|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
552101|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
552102|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
552103|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
552104|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
552105|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
552122|NCT00633594|E2|Reported Event|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
552106|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
552107|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
552108|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
552109|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
552110|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
552111|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
552112|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
552113|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
552114|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
552115|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
552116|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
552117|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
552118|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
552119|NCT00633594|O1|Outcome|Phase II - Lenalidomide 10mg PO QD|Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 IV Days 1, 4, 8, and 11 for Cycles 1-6
552120|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
552121|NCT00633594|E3|Reported Event|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
552241|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
552123|NCT00633594|E1|Reported Event|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14.
552124|NCT00633477|B3|Baseline|Total|Total of all reporting groups
552125|NCT00633477|B2|Baseline|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552126|NCT00633477|B1|Baseline|Resatorvid 2.4 mg/kg/Day|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours
552127|NCT00633477|P2|Participant Flow|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552128|NCT00633477|P1|Participant Flow|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
552129|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552130|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
552131|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552132|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
552133|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552134|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
552135|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552136|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
552137|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552138|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
552139|NCT00633477|E2|Reported Event|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
552140|NCT00633477|E1|Reported Event|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
552141|NCT00633464|B3|Baseline|Total|Total of all reporting groups
552142|NCT00633464|B2|Baseline|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552143|NCT00633464|B1|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552144|NCT00633464|P2|Participant Flow|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552145|NCT00633464|P1|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552146|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552147|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552148|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552149|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552150|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552151|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552152|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552153|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552154|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552155|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552156|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552157|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552158|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552159|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552160|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552161|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552162|NCT00633464|E2|Reported Event|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
552163|NCT00633464|E1|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
552164|NCT00633399|B3|Baseline|Total|Total of all reporting groups
552165|NCT00633399|B2|Baseline|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
552166|NCT00633399|B1|Baseline|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
552167|NCT00633399|P2|Participant Flow|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
552379|NCT00632749|B15|Baseline|Total|Total of all reporting groups
552168|NCT00633399|P1|Participant Flow|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
552169|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
552170|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
552171|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
552172|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
552173|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
552174|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
552175|NCT00633399|E2|Reported Event|Ziprasidone + Placebo|"Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
552176|NCT00633399|E1|Reported Event|Ziprasidone + Escitalpram|"Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
552177|NCT00633360|B3|Baseline|Total|Total of all reporting groups
552178|NCT00633360|B2|Baseline|Placebo|"Placebo~Placebo: Once daily by mouth"
552179|NCT00633360|B1|Baseline|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
552180|NCT00633360|P2|Participant Flow|Placebo|"Placebo~Placebo: Once daily by mouth"
552181|NCT00633360|P1|Participant Flow|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
552182|NCT00633360|O2|Outcome|Placebo|Placebo
552183|NCT00633360|O1|Outcome|Drospirenone and Ethinyl Estradiol|Drospirenone and ethinyl estradiol
552184|NCT00633360|O2|Outcome|Placebo|"Placebo~Placebo: Once daily by mouth"
552185|NCT00633360|O1|Outcome|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
552186|NCT00633360|E2|Reported Event|Placebo|"Placebo~Placebo: Once daily by mouth"
552187|NCT00633360|E1|Reported Event|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
552188|NCT00633256|B3|Baseline|Total|Total of all reporting groups
552189|NCT00633256|B2|Baseline|Placebo|Matched placebo
552190|NCT00633256|B1|Baseline|Cycloserine|50 mg cycloserine
552191|NCT00633256|P2|Participant Flow|Placebo|Matched placebo
552192|NCT00633256|P1|Participant Flow|Cycloserine|50 mg cycloserine
552193|NCT00633256|O2|Outcome|Placebo|Matched placebo
552194|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
552195|NCT00633256|O2|Outcome|Placebo|Matched placebo
552196|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
552197|NCT00633256|O2|Outcome|Placebo|Matched placebo
552198|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
552199|NCT00633256|E2|Reported Event|Placebo|Matched placebo
552200|NCT00633256|E1|Reported Event|Cycloserine|50 mg cycloserine
552201|NCT00633243|B3|Baseline|Total|Total of all reporting groups
552202|NCT00633243|B2|Baseline|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
552203|NCT00633243|B1|Baseline|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
552204|NCT00633243|P2|Participant Flow|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
552205|NCT00633243|P1|Participant Flow|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(PEG) was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
553032|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
552206|NCT00633243|O2|Outcome|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
552207|NCT00633243|O1|Outcome|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
552208|NCT00633243|E2|Reported Event|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
552209|NCT00633243|E1|Reported Event|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
552210|NCT00633217|B3|Baseline|Total|Total of all reporting groups
552211|NCT00633217|B2|Baseline|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
552212|NCT00633217|B1|Baseline|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
552213|NCT00633217|P2|Participant Flow|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
552214|NCT00633217|P1|Participant Flow|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
552215|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
552216|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
552217|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
552218|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
552219|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
552220|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
552221|NCT00633217|E2|Reported Event|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
552222|NCT00633217|E1|Reported Event|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
552223|NCT00633152|B3|Baseline|Total|Total of all reporting groups
552224|NCT00633152|B2|Baseline|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
552225|NCT00633152|B1|Baseline|Ceftaroline|Intramuscular every 12 hours
552226|NCT00633152|P2|Participant Flow|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
552227|NCT00633152|P1|Participant Flow|Ceftaroline|Intramuscular every 12 hours
552228|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg IV infusions over 60 minutes q12h
552229|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline fosamil was administered 600mg IM every 12 hours
552230|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg Intravenous infusions over 60 minutes every 12 hours
552231|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline was administered 600 mg as an Intramuscular injection every 12 hours
552232|NCT00633152|E2|Reported Event|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
552233|NCT00633152|E1|Reported Event|Ceftaroline|Intramuscular every 12 hours
552234|NCT00633139|B4|Baseline|Total|Total of all reporting groups
552235|NCT00633139|B3|Baseline|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
552236|NCT00633139|B2|Baseline|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
552237|NCT00633139|B1|Baseline|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
552238|NCT00633139|P3|Participant Flow|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
552239|NCT00633139|P2|Participant Flow|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
552240|NCT00633139|P1|Participant Flow|Cohort 1|Participants received a single dose of rhASA at 25 units per kilogram (U/kg) intravenous (IV) infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
552242|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
552243|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
552244|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
552245|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
552246|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
552247|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
552248|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
552249|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
552250|NCT00633139|E3|Reported Event|Cohort 3|Cohort 3: Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
552251|NCT00633139|E2|Reported Event|Cohort 2|Cohort 2: Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
552252|NCT00633139|E1|Reported Event|Cohort 1|Cohort 1: Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
552253|NCT00633126|B1|Baseline|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
552254|NCT00633126|P1|Participant Flow|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
552255|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
552256|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
552257|NCT00633126|E1|Reported Event|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
552258|NCT00633087|B1|Baseline|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
552259|NCT00633087|P1|Participant Flow|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
552260|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
552261|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
552262|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
552263|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
552264|NCT00633087|E1|Reported Event|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
552265|NCT00633074|B3|Baseline|Total|Total of all reporting groups
552266|NCT00633074|B2|Baseline|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552267|NCT00633074|B1|Baseline|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552268|NCT00633074|P2|Participant Flow|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552269|NCT00633074|P1|Participant Flow|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552270|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552271|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552272|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552273|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552274|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552275|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552276|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552277|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552278|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552279|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552280|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552281|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
553157|NCT00631189|B1|Baseline|Initial Phase|Initial phase (between V1 and V2)
552282|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552283|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552284|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552285|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552286|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552287|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552288|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552289|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552290|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552291|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552292|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552293|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552294|NCT00633074|E2|Reported Event|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
552295|NCT00633074|E1|Reported Event|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
552296|NCT00633009|B4|Baseline|Total|Total of all reporting groups
552297|NCT00633009|B3|Baseline|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
552298|NCT00633009|B2|Baseline|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
552299|NCT00633009|B1|Baseline|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
552300|NCT00633009|P3|Participant Flow|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
552301|NCT00633009|P2|Participant Flow|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
552302|NCT00633009|P1|Participant Flow|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. All participants received a placebo skin test concurrently with active drug.
552303|NCT00633009|O3|Outcome|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
552304|NCT00633009|O2|Outcome|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
552305|NCT00633009|O1|Outcome|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
552306|NCT00633009|O3|Outcome|50 ug Study Group|
552307|NCT00633009|O2|Outcome|30 ug Study Group|
552308|NCT00633009|O1|Outcome|15 ug Study Group|
552309|NCT00633009|E3|Reported Event|50 ug Study Group|
552310|NCT00633009|E2|Reported Event|30 ug Study Group|
552311|NCT00633009|E1|Reported Event|15 ug Study Group|
552312|NCT00632970|B3|Baseline|Total|Total of all reporting groups
552313|NCT00632970|B2|Baseline|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
552314|NCT00632970|B1|Baseline|Raltegravir|Raltegravir: 1 400mg tablet twice a day
552315|NCT00632970|P2|Participant Flow|Lopinavir/Ritonavir|Patients with HIV infection randomized to receive lopinavir/ritonavir with truvada
552316|NCT00632970|P1|Participant Flow|Raltegravir|Patients with HIV infection randomized to receive raltegravir with truvada
552317|NCT00632970|O2|Outcome|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
552318|NCT00632970|O1|Outcome|Raltegravir|Raltegravir: 1 400mg tablet twice a day
552319|NCT00632970|E2|Reported Event|Lopinavir/Ritonavir|Lopinavir/Ritonavir: 2 tablets twice a day
552320|NCT00632970|E1|Reported Event|Raltegravir|Raltegravir: 1 400mg tablet twice a day
552321|NCT00632931|B1|Baseline|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
553158|NCT00631189|P4|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg
552322|NCT00632931|P3|Participant Flow|All Participants: Part 2|"Vorinostat 400 mg once daily.~Ten participants changed dosage to vorinostat 300 mg daily during Part 2."
552323|NCT00632931|P2|Participant Flow|Placebo Then Vorinostat: Part 1|Single dose matching placebo in Period 1 followed by a three day wash out period, then single dose 800 mg vorinostat in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
552324|NCT00632931|P1|Participant Flow|Vorinostat Then Placebo: Part 1|Single dose 800 mg vorinostat in Period 1 followed by a three day wash out period, then matching placebo in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
552325|NCT00632931|O2|Outcome|Placebo|
552326|NCT00632931|O1|Outcome|Vorinostat|
552327|NCT00632931|O2|Outcome|Placebo|
552328|NCT00632931|O1|Outcome|Vorinostat|
552329|NCT00632931|O2|Outcome|Placebo|
552330|NCT00632931|O1|Outcome|Vorinostat|
552331|NCT00632931|O2|Outcome|Placebo|
552332|NCT00632931|O1|Outcome|Vorinostat|
552333|NCT00632931|O2|Outcome|Placebo|
552334|NCT00632931|O1|Outcome|Vorinostat|
552335|NCT00632931|O2|Outcome|Placebo|
552336|NCT00632931|O1|Outcome|Vorinostat|
552337|NCT00632931|O2|Outcome|Placebo|
552338|NCT00632931|O1|Outcome|Vorinostat|
552339|NCT00632931|O2|Outcome|Placebo|
552340|NCT00632931|O1|Outcome|Vorinostat|
552341|NCT00632931|E1|Reported Event|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
552342|NCT00632814|B4|Baseline|Total|Total of all reporting groups
552343|NCT00632814|B3|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552344|NCT00632814|B2|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552345|NCT00632814|B1|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552346|NCT00632814|P3|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552347|NCT00632814|P2|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552348|NCT00632814|P1|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552349|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552350|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552351|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552352|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552353|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552354|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552355|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552356|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552357|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
553159|NCT00631189|P3|Participant Flow|Pravastatin|Pravastatin 40 mg
552358|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552359|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552360|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552361|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552362|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552363|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552364|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552365|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552366|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552367|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552368|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552369|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552370|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552371|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552372|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552373|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552374|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552375|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552376|NCT00632814|E3|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
552377|NCT00632814|E2|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
552378|NCT00632814|E1|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
552380|NCT00632749|B14|Baseline|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552381|NCT00632749|B13|Baseline|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552382|NCT00632749|B12|Baseline|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552383|NCT00632749|B11|Baseline|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552384|NCT00632749|B10|Baseline|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552385|NCT00632749|B9|Baseline|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552386|NCT00632749|B8|Baseline|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552387|NCT00632749|B7|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552388|NCT00632749|B6|Baseline|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552389|NCT00632749|B5|Baseline|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552390|NCT00632749|B4|Baseline|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552391|NCT00632749|B3|Baseline|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552392|NCT00632749|B2|Baseline|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552393|NCT00632749|B1|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552394|NCT00632749|P14|Participant Flow|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552395|NCT00632749|P13|Participant Flow|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552396|NCT00632749|P12|Participant Flow|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552397|NCT00632749|P11|Participant Flow|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552398|NCT00632749|P10|Participant Flow|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552399|NCT00632749|P9|Participant Flow|80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552400|NCT00632749|P8|Participant Flow|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552401|NCT00632749|P7|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552402|NCT00632749|P6|Participant Flow|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552403|NCT00632749|P5|Participant Flow|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552404|NCT00632749|P4|Participant Flow|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552405|NCT00632749|P3|Participant Flow|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552406|NCT00632749|P2|Participant Flow|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552407|NCT00632749|P1|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552408|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552409|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552410|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552411|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552412|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552413|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552414|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552702|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
552415|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552416|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552417|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552418|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552419|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552420|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552421|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552422|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552423|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552424|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552425|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552426|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552427|NCT00632749|O9|Outcome|80 mg BI 811283 +20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552428|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552429|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552430|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552431|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552432|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552433|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552434|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552435|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552436|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552437|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552438|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552439|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552440|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552441|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552442|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552443|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552444|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552445|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552446|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552447|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552448|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552449|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552450|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552451|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552452|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552453|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552454|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552455|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552456|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552457|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552458|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552459|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552460|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552461|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552462|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552463|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552464|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552465|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552466|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552467|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552468|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552469|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552470|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552471|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552472|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552473|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552474|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552475|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552476|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552477|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552478|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552479|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552480|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552481|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552482|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552483|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552484|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552485|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552486|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552487|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552488|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552489|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552490|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552491|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552492|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552493|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552494|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552495|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552496|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552497|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552498|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552499|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552500|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552501|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552502|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552503|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552504|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552505|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552506|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552507|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552508|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552509|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552510|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552511|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552512|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552513|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552514|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552515|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552516|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552517|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552518|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552519|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552520|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552521|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552522|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552523|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552524|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552525|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552526|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552527|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552528|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552529|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552530|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552531|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552532|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552533|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552534|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552535|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552536|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552537|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552538|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552539|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552540|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552541|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552542|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552543|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552544|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552545|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552546|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552547|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552548|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552549|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552550|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552551|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552552|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552553|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552554|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552555|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552556|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552557|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552558|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552559|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552560|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552561|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552562|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552563|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552564|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552565|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552566|NCT00632749|O6|Outcome|120mg (BI 811283+ Cytarabine)- Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552567|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552568|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552569|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine- Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552570|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552571|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552572|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552573|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552574|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552575|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552576|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552577|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552578|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552579|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552580|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552581|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552582|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552583|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552584|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552585|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552586|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552587|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552588|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552589|NCT00632749|O11|Outcome|240 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552590|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552591|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552592|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552593|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552594|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552595|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552596|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552597|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552598|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552599|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552600|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552601|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552602|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552603|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552604|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552605|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552606|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552607|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552608|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552609|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552610|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552611|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552612|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552613|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552614|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552615|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552616|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552617|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552618|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552619|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552620|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552621|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552622|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552623|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552624|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552625|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552626|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552627|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552628|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552629|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552630|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552631|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552632|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552633|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552634|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552635|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552636|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552637|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552638|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552639|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552640|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552641|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552642|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552643|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552644|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552645|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552646|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552647|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552648|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552649|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552650|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552651|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552652|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552653|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552654|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552655|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552656|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552657|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552658|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552659|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552660|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552661|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552662|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552663|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552664|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552665|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552666|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552667|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552668|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552669|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552670|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552671|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552672|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552673|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552674|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552675|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552676|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552677|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552678|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552679|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552680|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552681|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552682|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552683|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552703|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
553160|NCT00631189|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
552684|NCT00632749|O2|Outcome|Treatment Schedule B|"Subjects received BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 40, 80, 160, 240, 300, 360 and 420 mg being used in Schedule B.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552685|NCT00632749|O1|Outcome|Treatment Schedule A|"Subjects received BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 15, 30, 60, 100 and 120 mg used in Schedule A.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552686|NCT00632749|E14|Reported Event|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552687|NCT00632749|E13|Reported Event|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552688|NCT00632749|E12|Reported Event|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552689|NCT00632749|E11|Reported Event|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552690|NCT00632749|E10|Reported Event|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552691|NCT00632749|E9|Reported Event|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552692|NCT00632749|E8|Reported Event|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552693|NCT00632749|E7|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552694|NCT00632749|E6|Reported Event|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552695|NCT00632749|E5|Reported Event|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552696|NCT00632749|E4|Reported Event|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552697|NCT00632749|E3|Reported Event|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552698|NCT00632749|E2|Reported Event|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552699|NCT00632749|E1|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
552700|NCT00632736|B1|Baseline|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
552701|NCT00632736|P1|Participant Flow|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
552704|NCT00632736|E1|Reported Event|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
552705|NCT00632632|B3|Baseline|Total|Total of all reporting groups
552706|NCT00632632|B2|Baseline|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
552707|NCT00632632|B1|Baseline|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
552708|NCT00632632|P2|Participant Flow|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
552709|NCT00632632|P1|Participant Flow|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
552710|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
552711|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
552712|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
552713|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
552714|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
552715|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
552716|NCT00632632|E2|Reported Event|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
552717|NCT00632632|E1|Reported Event|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
552718|NCT00632619|B3|Baseline|Total|Total of all reporting groups
552719|NCT00632619|B2|Baseline|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552720|NCT00632619|B1|Baseline|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552721|NCT00632619|P2|Participant Flow|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552722|NCT00632619|P1|Participant Flow|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552723|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552724|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552796|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
552725|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552726|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552727|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552728|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552729|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552730|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552731|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552732|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552733|NCT00632619|E2|Reported Event|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
552734|NCT00632619|E1|Reported Event|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
552735|NCT00632541|B1|Baseline|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
552736|NCT00632541|P1|Participant Flow|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week. 1 Cycle = 4 weeks. Imaging every third cycle.
552737|NCT00632541|O1|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle~Sorafenib: Sorafenib 200mg po daily~Bevacizumab: Bevacizumab 5mg/kg every other week~1 Cycle = 4 weeks~Imaging: Imaging every third cycle"
552738|NCT00632541|O1|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle~Sorafenib: Sorafenib 200mg po daily~Bevacizumab: Bevacizumab 5mg/kg every other week~1 Cycle = 4 weeks~Imaging: Imaging every third cycle"
552739|NCT00632541|O1|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle~Sorafenib: Sorafenib 200mg po daily~Bevacizumab: Bevacizumab 5mg/kg every other week~1 Cycle = 4 weeks~Imaging: Imaging every third cycle"
552740|NCT00632541|O1|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle~Sorafenib: Sorafenib 200mg po daily~Bevacizumab: Bevacizumab 5mg/kg every other week~1 Cycle = 4 weeks~Imaging: Imaging every third cycle"
552741|NCT00632541|E1|Reported Event|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
552742|NCT00632502|B3|Baseline|Total|Total of all reporting groups
552743|NCT00632502|B2|Baseline|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552744|NCT00632502|B1|Baseline|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552745|NCT00632502|P2|Participant Flow|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552746|NCT00632502|P1|Participant Flow|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552747|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552748|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552749|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552750|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552751|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552752|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552753|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552754|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552755|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552756|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552757|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552758|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552759|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552760|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552761|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
552762|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552763|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
552764|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552765|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552766|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552767|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552768|NCT00632502|E2|Reported Event|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
552769|NCT00632502|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
552770|NCT00632489|B4|Baseline|Total|Total of all reporting groups
552771|NCT00632489|B3|Baseline|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552772|NCT00632489|B2|Baseline|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552773|NCT00632489|B1|Baseline|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
552774|NCT00632489|P3|Participant Flow|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552775|NCT00632489|P2|Participant Flow|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552797|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552776|NCT00632489|P1|Participant Flow|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
552777|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552778|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552779|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
552780|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552781|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552782|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
552783|NCT00632489|E3|Reported Event|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552784|NCT00632489|E2|Reported Event|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
552785|NCT00632489|E1|Reported Event|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
552786|NCT00632463|B4|Baseline|Total|Total of all reporting groups
552787|NCT00632463|B3|Baseline|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
552788|NCT00632463|B2|Baseline|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552789|NCT00632463|B1|Baseline|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552790|NCT00632463|P3|Participant Flow|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
552791|NCT00632463|P2|Participant Flow|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552792|NCT00632463|P1|Participant Flow|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552793|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
552794|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552795|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552798|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552799|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
552800|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552801|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552802|NCT00632463|E3|Reported Event|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
552803|NCT00632463|E2|Reported Event|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552804|NCT00632463|E1|Reported Event|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
552805|NCT00632424|B4|Baseline|Total|Total of all reporting groups
552806|NCT00632424|B3|Baseline|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
552807|NCT00632424|B2|Baseline|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
552808|NCT00632424|B1|Baseline|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
552809|NCT00632424|P1|Participant Flow|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle.
552810|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
552811|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
552812|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
552813|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
552814|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
552815|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
552816|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
552817|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
552818|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
552819|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
552820|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
552821|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
552822|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
552823|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
552824|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
552825|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
552826|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
552827|NCT00632424|E3|Reported Event|Ixa 150 mg/Day|
552828|NCT00632424|E2|Reported Event|Ixa 120 mg/Day|
552829|NCT00632424|E1|Reported Event|Ixa 90 mg/Day|
552830|NCT00632411|B3|Baseline|Total|Total of all reporting groups
552831|NCT00632411|B2|Baseline|Reactive Group|"Participant will contact the research study staff to initiate sessions.~2 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.~Six sessions will be delivered to the participant as long as the participant calls to initiate the sessions.~Phone session 1 will focus on smoking reduction.~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.~Phone session 3 will focus on the first days after the quit date.~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.~Phone session 5 will focus on short-term relapse prevention.~Phone session 6 will focus on long-term relapse prevention."
552832|NCT00632411|B1|Baseline|Proactive Group|"Research study staff will contact participant to initiate sessions.~8 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.~Six sessions will be proactively delivered to the participant.~Phone session 1 will focus on smoking reduction.~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.~Phone session 3 will focus on the first days after the quit date.~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.~Phone session 5 will focus on short-term relapse prevention.~Phone session 6 will focus on long-term relapse prevention."
552833|NCT00632411|P2|Participant Flow|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
552834|NCT00632411|P1|Participant Flow|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
552835|NCT00632411|O2|Outcome|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
552836|NCT00632411|O1|Outcome|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
552837|NCT00632411|E2|Reported Event|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
552838|NCT00632411|E1|Reported Event|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
552839|NCT00632281|B1|Baseline|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
552840|NCT00632281|P1|Participant Flow|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
552841|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
552842|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
552843|NCT00632281|E1|Reported Event|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
552844|NCT00632229|B3|Baseline|Total|Total of all reporting groups
552845|NCT00632229|B2|Baseline|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552846|NCT00632229|B1|Baseline|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552847|NCT00632229|P2|Participant Flow|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552848|NCT00632229|P1|Participant Flow|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552849|NCT00632229|O2|Outcome|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552850|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552851|NCT00632229|O2|Outcome|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552852|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552853|NCT00632229|E2|Reported Event|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552854|NCT00632229|E1|Reported Event|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
552855|NCT00632203|B3|Baseline|Total|Total of all reporting groups
552856|NCT00632203|B2|Baseline|Observation|Observation
552857|NCT00632203|B1|Baseline|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552858|NCT00632203|P2|Participant Flow|Observation|Observation
552859|NCT00632203|P1|Participant Flow|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552860|NCT00632203|O2|Outcome|Observation|Observation
552861|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552862|NCT00632203|O2|Outcome|Observation|Observation
552863|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552864|NCT00632203|O2|Outcome|Observation|Observation
552865|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552866|NCT00632203|O2|Outcome|Observation|Observation
552867|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552868|NCT00632203|O2|Outcome|Observation|Observation
552869|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552870|NCT00632203|O2|Outcome|Observation|Observation
552871|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552872|NCT00632203|O2|Outcome|Observation|Observation
552873|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552874|NCT00632203|E2|Reported Event|Observation|Observation
552875|NCT00632203|E1|Reported Event|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
552876|NCT00632125|B1|Baseline|HX575|HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the SmPC
552877|NCT00632125|P1|Participant Flow|HX575|HX575 recombinant human erythropoietin alfa: HX575 epoetin alfa i.v. will be administered according to the summary of product characteristics (SmPC)
552878|NCT00632125|O1|Outcome|HX575|HX575 administered i.v. according to the SmPC
552879|NCT00632125|E1|Reported Event|HX575|HX575 administered i.v. according to the SmPC
552880|NCT00632099|B3|Baseline|Total|Total of all reporting groups
552881|NCT00632099|B2|Baseline|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
552882|NCT00632099|B1|Baseline|Matched Placebo|"matched placebo~Placebo: matched placebo"
552883|NCT00632099|P2|Participant Flow|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
552884|NCT00632099|P1|Participant Flow|Matched Placebo|"matched placebo~Placebo: matched placebo"
552885|NCT00632099|O2|Outcome|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
552886|NCT00632099|O1|Outcome|Matched Placebo|"matched placebo~Placebo: matched placebo"
552887|NCT00632099|E2|Reported Event|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
552888|NCT00632099|E1|Reported Event|Matched Placebo|"matched placebo~Placebo: matched placebo"
552889|NCT00632021|B3|Baseline|Total|Total of all reporting groups
552890|NCT00632021|B2|Baseline|Intervention|Intervention arm
552891|NCT00632021|B1|Baseline|Control (Usual Care)|Control (usual care) arm
552892|NCT00632021|P2|Participant Flow|Intervention|Intervention arm
552893|NCT00632021|P1|Participant Flow|Control (Usual Care)|Control (usual care) arm
552894|NCT00632021|O2|Outcome|Intervention|Intervention arm
552895|NCT00632021|O1|Outcome|Control (Usual Care)|Control (usual care) arm
552896|NCT00632021|O2|Outcome|Intervention|Intervention arm
552897|NCT00632021|O1|Outcome|Control|Control (usual care) arm
552898|NCT00632021|E2|Reported Event|Intervention|Intervention arm
552899|NCT00632021|E1|Reported Event|Control (Usual Care)|Control (usual care) arm
552900|NCT00631969|B3|Baseline|Total|Total of all reporting groups
552901|NCT00631969|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552902|NCT00631969|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552903|NCT00631969|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552904|NCT00631969|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552905|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
552906|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
552907|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
552908|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
552909|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
552910|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
552911|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
552912|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
552913|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552914|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552915|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552916|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552917|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552918|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552919|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552920|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552921|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552922|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552923|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552924|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552925|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552926|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552927|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552928|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552929|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552930|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552931|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552932|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552933|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552934|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552935|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552936|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552937|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552938|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552939|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552940|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552941|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552942|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552943|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552944|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552945|NCT00631969|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552946|NCT00631969|E1|Reported Event|Vardenafil ODT (STAXYN, BAY 38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
552947|NCT00631917|B3|Baseline|Total|Total of all reporting groups
552948|NCT00631917|B2|Baseline|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552949|NCT00631917|B1|Baseline|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552950|NCT00631917|P2|Participant Flow|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552951|NCT00631917|P1|Participant Flow|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552952|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552953|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552954|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552955|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552956|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552957|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552958|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552959|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552960|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552961|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552962|NCT00631917|E2|Reported Event|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
552963|NCT00631917|E1|Reported Event|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
552964|NCT00631748|B3|Baseline|Total|Total of all reporting groups
552965|NCT00631748|B2|Baseline|Placebo|Placebo (sugar pill)
552966|NCT00631748|B1|Baseline|Study Drug|Oral quetiapine
552967|NCT00631748|P2|Participant Flow|Placebo|Placebo (sugar pill)
552968|NCT00631748|P1|Participant Flow|Study Drug|Oral quetiapine
552969|NCT00631748|O2|Outcome|Placebo|match placebo (sugar pill)
552970|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
552971|NCT00631748|O2|Outcome|Placebo|matched placebo (sugar pill)
552972|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
552973|NCT00631748|E2|Reported Event|Placebo|Placebo (sugar pill)
552974|NCT00631748|E1|Reported Event|Study Drug|Oral quetiapine
552975|NCT00631696|B3|Baseline|Total|Total of all reporting groups
552976|NCT00631696|B2|Baseline|Placebo|Placebo matching pregabalin treatment.
552977|NCT00631696|B1|Baseline|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552978|NCT00631696|P2|Participant Flow|Placebo|Placebo matching pregabalin treatment.
552979|NCT00631696|P1|Participant Flow|Pregabalin|Pregabalin 50 milligrams (mg) by mouth (PO) twice a day (BID) starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552980|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552981|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552982|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552983|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552984|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552985|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552986|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552987|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552988|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
553031|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
552989|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552990|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552991|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552992|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552993|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552994|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552995|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552996|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552997|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
552998|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
552999|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
553000|NCT00631696|E2|Reported Event|Placebo|Placebo matching pregabalin treatment.
553001|NCT00631696|E1|Reported Event|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
553002|NCT00631670|B3|Baseline|Total|Total of all reporting groups
553003|NCT00631670|B2|Baseline|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
553004|NCT00631670|B1|Baseline|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
553005|NCT00631670|P2|Participant Flow|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
553006|NCT00631670|P1|Participant Flow|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
553007|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
553008|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
553009|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
553010|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
553011|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
553012|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
553013|NCT00631670|O2|Outcome|25 Treatments Grouop|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
553014|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one treatment
553015|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
553016|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
553017|NCT00631670|E2|Reported Event|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
553018|NCT00631670|E1|Reported Event|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
553019|NCT00631657|B3|Baseline|Total|Total of all reporting groups
553020|NCT00631657|B2|Baseline|Placebo|Participants receive placebo tablets, administered QD for 6 months
553021|NCT00631657|B1|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553022|NCT00631657|P3|Participant Flow|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
553023|NCT00631657|P2|Participant Flow|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
553024|NCT00631657|P1|Participant Flow|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered once a day (QD) for 6 months, then participants receive esmirtazapine 4.5 mg tablets, administered QD for 7 days
553025|NCT00631657|O3|Outcome|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
553026|NCT00631657|O2|Outcome|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
553027|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by esmirtazapine 4.5 mg tablets, administered QD for 7 days during the Discontinuation Period
553028|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months.
553029|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553030|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
553033|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553034|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
553035|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553036|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
553037|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553038|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
553039|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553040|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
553041|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553042|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
553043|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553044|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
553045|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553046|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
553047|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
553048|NCT00631657|E2|Reported Event|Placebo|Participants receive placebo tablets, administered QD
553049|NCT00631657|E1|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD
553050|NCT00631540|B1|Baseline|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553051|NCT00631540|P1|Participant Flow|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553052|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553053|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553054|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553055|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553056|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553057|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553058|NCT00631540|E1|Reported Event|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
553059|NCT00631488|B4|Baseline|Total|Total of all reporting groups
553060|NCT00631488|B3|Baseline|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553061|NCT00631488|B2|Baseline|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553062|NCT00631488|B1|Baseline|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553063|NCT00631488|P3|Participant Flow|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553064|NCT00631488|P2|Participant Flow|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553065|NCT00631488|P1|Participant Flow|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553066|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553067|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553084|NCT00631475|B1|Baseline|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553068|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553069|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553070|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553071|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553072|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553073|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553074|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553075|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553076|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553077|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553078|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553079|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553080|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553081|NCT00631488|E3|Reported Event|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553082|NCT00631488|E2|Reported Event|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
553083|NCT00631488|E1|Reported Event|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
553085|NCT00631475|P1|Participant Flow|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553086|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553087|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553088|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553089|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553090|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553091|NCT00631475|E1|Reported Event|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
553092|NCT00631449|B3|Baseline|Total|Total of all reporting groups
553093|NCT00631449|B2|Baseline|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553094|NCT00631449|B1|Baseline|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553095|NCT00631449|P2|Participant Flow|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553096|NCT00631449|P1|Participant Flow|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553097|NCT00631449|O2|Outcome|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553098|NCT00631449|O1|Outcome|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553099|NCT00631449|E2|Reported Event|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553100|NCT00631449|E1|Reported Event|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
553101|NCT00631410|B3|Baseline|Total|Total of all reporting groups
553102|NCT00631410|B2|Baseline|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
553103|NCT00631410|B1|Baseline|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553104|NCT00631410|P2|Participant Flow|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553105|NCT00631410|P1|Participant Flow|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553106|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553107|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553151|NCT00631358|E2|Reported Event|No Treatment|Healthy normal control group receiving no treatment
553152|NCT00631358|E1|Reported Event|Maxidex|Maxidex 1 drop in each eye 2 times daily
553153|NCT00631189|B5|Baseline|Total|Total of all reporting groups
553108|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553109|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553110|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553111|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553112|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553113|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553114|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
553115|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
553116|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
553117|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553118|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553119|NCT00631410|E2|Reported Event|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
553120|NCT00631410|E1|Reported Event|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
553121|NCT00631371|B3|Baseline|Total|Total of all reporting groups
553154|NCT00631189|B4|Baseline|Rosuvastatin|Rosuvastatin 5 mg
553155|NCT00631189|B3|Baseline|Pravastatin|Pravastatin 40 mg
553156|NCT00631189|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
553122|NCT00631371|B2|Baseline|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553123|NCT00631371|B1|Baseline|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553124|NCT00631371|P2|Participant Flow|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553125|NCT00631371|P1|Participant Flow|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553126|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553127|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553128|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553129|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553130|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553131|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553132|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553133|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553134|NCT00631371|E2|Reported Event|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553135|NCT00631371|E1|Reported Event|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
553136|NCT00631358|B3|Baseline|Total|Total of all reporting groups
553137|NCT00631358|B2|Baseline|No Treatment|Healthy normal control group receiving no treatment
553138|NCT00631358|B1|Baseline|Maxidex|Maxidex 1 drop in each eye 2 times daily
553139|NCT00631358|P2|Participant Flow|No Treatment|Healthy normal control group receiving no treatment
553140|NCT00631358|P1|Participant Flow|Maxidex|Maxidex 1 drop in each eye 2 times daily
553141|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
553142|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
553143|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
553144|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
553145|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
553146|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
553147|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
553148|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
553149|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
553150|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
553161|NCT00631189|P1|Participant Flow|Initial Phase|Initial phase (between V1 and V2)
553162|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553163|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553164|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553165|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553166|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553167|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553168|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553169|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553170|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553171|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553172|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553173|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553174|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553175|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553176|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553177|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553178|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553179|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553180|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553181|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553182|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553183|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553184|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553185|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553186|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553187|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553188|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553189|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553190|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553191|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553192|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553193|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553194|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
553195|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
553196|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
553197|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
553198|NCT00631189|E4|Reported Event|Rosuvastatin|Rosuvastatin 5 mg
553199|NCT00631189|E3|Reported Event|Pravastatin|Pravastatin 40 mg
553200|NCT00631189|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
553201|NCT00631189|E1|Reported Event|Initial Phase|Initial phase (between V1 and V2)
553202|NCT00631020|B1|Baseline|CBME +/- NRT|6 weeks of once a week CBME with optional 4 weeks NRT
553203|NCT00631020|P1|Participant Flow|CBME +/- NRT|6 weeks CBME with optional NRT for 4 weeks
553204|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
553205|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
553206|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
553207|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
553208|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
553209|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
553210|NCT00631020|E1|Reported Event|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
553211|NCT00631007|B7|Baseline|Total|Total of all reporting groups
553212|NCT00631007|B6|Baseline|Placebo|placebo administered once-daily
553213|NCT00631007|B5|Baseline|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
553214|NCT00631007|B4|Baseline|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
553215|NCT00631007|B3|Baseline|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
553216|NCT00631007|B2|Baseline|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
553217|NCT00631007|B1|Baseline|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
553218|NCT00631007|P6|Participant Flow|Placebo|placebo administered once-daily
553219|NCT00631007|P5|Participant Flow|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
553220|NCT00631007|P4|Participant Flow|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
553221|NCT00631007|P3|Participant Flow|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
553222|NCT00631007|P2|Participant Flow|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
553223|NCT00631007|P1|Participant Flow|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
553224|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
553225|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
553226|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
553227|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
553228|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
553229|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
553230|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
553231|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
553232|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
553233|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
553234|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
553235|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
553236|NCT00631007|E6|Reported Event|Placebo|placebo administered once-daily
553237|NCT00631007|E5|Reported Event|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
553238|NCT00631007|E4|Reported Event|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
553239|NCT00631007|E3|Reported Event|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
553240|NCT00631007|E2|Reported Event|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
553241|NCT00631007|E1|Reported Event|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
553242|NCT00630994|B1|Baseline|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553243|NCT00630994|P1|Participant Flow|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553244|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553245|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553246|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553247|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553248|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553249|NCT00630994|E1|Reported Event|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
553250|NCT00630955|B4|Baseline|Total|Total of all reporting groups
553251|NCT00630955|B3|Baseline|40 mg Memantine|
553252|NCT00630955|B2|Baseline|20 mg Memantine|
553253|NCT00630955|B1|Baseline|0 mg Memantine|
553254|NCT00630955|P3|Participant Flow|40 mg Memantine|Participants randomized to 40mg memantine PO qd
553255|NCT00630955|P2|Participant Flow|20 mg Memantine|Participants randomized to 20 mg memantine PO qd
553256|NCT00630955|P1|Participant Flow|0 mg Memantine|Participants who received placebo PO qd
553257|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
553258|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
553259|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
553260|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
553261|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
553262|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
553263|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
553264|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
553265|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
553266|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
553267|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
553268|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
553269|NCT00630955|E3|Reported Event|40 mg|Participants randomized to 40mg memantine
553270|NCT00630955|E2|Reported Event|20 mg|Participants randomized to 20 mg memantine
553271|NCT00630955|E1|Reported Event|0 mg|Participants who received placebo
553272|NCT00630916|B1|Baseline|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
553273|NCT00630916|P1|Participant Flow|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
553274|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
553275|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
553276|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
553277|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
553278|NCT00630916|E1|Reported Event|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
553279|NCT00630877|B4|Baseline|Total|Total of all reporting groups
553280|NCT00630877|B3|Baseline|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
553281|NCT00630877|B2|Baseline|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
553282|NCT00630877|B1|Baseline|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
553283|NCT00630877|P3|Participant Flow|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
553284|NCT00630877|P2|Participant Flow|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
553285|NCT00630877|P1|Participant Flow|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
553286|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
553287|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
553288|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
553289|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
553290|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
553291|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
553292|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
553293|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
553294|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
553295|NCT00630877|O3|Outcome|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
553296|NCT00630877|O2|Outcome|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
553297|NCT00630877|O1|Outcome|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
553298|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
553299|NCT00630877|E3|Reported Event|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
553300|NCT00630877|E2|Reported Event|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
553301|NCT00630877|E1|Reported Event|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
553302|NCT00630864|B1|Baseline|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553303|NCT00630864|P1|Participant Flow|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553304|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553305|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553306|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553307|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553308|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553309|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553310|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553311|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553312|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553623|NCT00630331|P1|Participant Flow|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553313|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553314|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553315|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553316|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553317|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553318|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553319|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553320|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553321|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553322|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553323|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553324|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553325|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553326|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553327|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553328|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553329|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553330|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553331|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553332|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553333|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553334|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553335|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553336|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553337|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553338|NCT00630864|E1|Reported Event|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
553339|NCT00630838|B3|Baseline|Total|Total of all reporting groups
553340|NCT00630838|B2|Baseline|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
553341|NCT00630838|B1|Baseline|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
553342|NCT00630838|P2|Participant Flow|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
553343|NCT00630838|P1|Participant Flow|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
553344|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
553375|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553345|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
553346|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
553347|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
553348|NCT00630838|E2|Reported Event|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
553349|NCT00630838|E1|Reported Event|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
553350|NCT00630825|B5|Baseline|Total|Total of all reporting groups
553351|NCT00630825|B4|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553352|NCT00630825|B3|Baseline|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553353|NCT00630825|B2|Baseline|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553354|NCT00630825|B1|Baseline|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553355|NCT00630825|P4|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553356|NCT00630825|P3|Participant Flow|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553357|NCT00630825|P2|Participant Flow|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553358|NCT00630825|P1|Participant Flow|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553359|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553360|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553361|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553362|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553363|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553364|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553365|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553366|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553367|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553368|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553369|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553370|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553371|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553372|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553373|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553374|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553624|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553376|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553377|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553378|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553379|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553380|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553381|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553382|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553383|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553384|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553385|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553386|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553387|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553388|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553389|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553390|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553391|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553392|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553393|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553394|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553395|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553396|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553397|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553398|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553399|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553400|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553401|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553402|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553403|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553404|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553405|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553406|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553407|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553408|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553409|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553410|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553411|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553412|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553413|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553414|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553415|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553416|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553506|NCT00630539|P2|Participant Flow|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553417|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553418|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553419|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553420|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553421|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553422|NCT00630825|E4|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
553423|NCT00630825|E3|Reported Event|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
553424|NCT00630825|E2|Reported Event|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
553425|NCT00630825|E1|Reported Event|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
553426|NCT00630786|B4|Baseline|Total|Total of all reporting groups
553427|NCT00630786|B3|Baseline|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553428|NCT00630786|B2|Baseline|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553429|NCT00630786|B1|Baseline|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553430|NCT00630786|P3|Participant Flow|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553431|NCT00630786|P2|Participant Flow|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553432|NCT00630786|P1|Participant Flow|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553433|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553434|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553435|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553436|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553437|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553438|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553439|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553440|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553441|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553442|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553443|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553444|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553445|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553446|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553447|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553448|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
553449|NCT00630786|E1|Reported Event|Panitumumab + AMG 655|
553450|NCT00630747|B1|Baseline|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553451|NCT00630747|P1|Participant Flow|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered by intravenous (IV) infusion once-weekly.
553452|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553453|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553454|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553455|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553456|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553457|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553458|NCT00630747|E1|Reported Event|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
553459|NCT00630734|B4|Baseline|Total|Total of all reporting groups
553460|NCT00630734|B3|Baseline|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553461|NCT00630734|B2|Baseline|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553462|NCT00630734|B1|Baseline|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553463|NCT00630734|P3|Participant Flow|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553464|NCT00630734|P2|Participant Flow|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
553465|NCT00630734|P1|Participant Flow|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553466|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553467|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
553468|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553469|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553470|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
553471|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553472|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553473|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
553474|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553475|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553621|NCT00630331|P3|Participant Flow|Placebo|One dose of phosphate buffered solution (PBS).
553476|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
553477|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553478|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553479|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553480|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553481|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553482|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553483|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553484|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553485|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553486|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553487|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553488|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553489|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553490|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553491|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553492|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553493|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553494|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553495|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1*1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
553496|NCT00630734|E3|Reported Event|Pravastatin + Darunavir/Ritonavir|Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.
553497|NCT00630734|E2|Reported Event|Darunavir/Ritonavir Alone|Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.
553498|NCT00630734|E1|Reported Event|Pravastatin Alone|Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.
553499|NCT00630539|B5|Baseline|Total|Total of all reporting groups
553500|NCT00630539|B4|Baseline|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553501|NCT00630539|B3|Baseline|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553502|NCT00630539|B2|Baseline|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553503|NCT00630539|B1|Baseline|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553504|NCT00630539|P4|Participant Flow|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553505|NCT00630539|P3|Participant Flow|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553805|NCT00629239|O2|Outcome|Placebo|Placebo
553507|NCT00630539|P1|Participant Flow|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553508|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553509|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553510|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553511|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553512|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553513|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553514|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553515|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553516|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553517|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553518|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553519|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553520|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553521|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553522|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553523|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553524|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553525|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553526|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553527|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553528|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553529|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553530|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553531|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553532|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553533|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553534|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553535|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553536|NCT00630539|O8|Outcome|Subjects on Ospemifene 30 mg/Day (Week 12)|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553537|NCT00630539|O7|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553538|NCT00630539|O6|Outcome|Subjects on Ospemifine 15 mg/Day (Week 12)|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553539|NCT00630539|O5|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553540|NCT00630539|O4|Outcome|Subjects on Ospemifene 5 mg/Day (Week 12)|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553541|NCT00630539|O3|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553542|NCT00630539|O2|Outcome|Subjects on Placebo (Week 12)|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553543|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553544|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553545|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553546|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553547|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553548|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553549|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553550|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553551|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553552|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553553|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553554|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553555|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553556|NCT00630539|E4|Reported Event|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
553557|NCT00630539|E3|Reported Event|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
553558|NCT00630539|E2|Reported Event|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
553559|NCT00630539|E1|Reported Event|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
553560|NCT00630487|B3|Baseline|Total|Total of all reporting groups
553561|NCT00630487|B2|Baseline|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553562|NCT00630487|B1|Baseline|Placebo|
553563|NCT00630487|P2|Participant Flow|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553564|NCT00630487|P1|Participant Flow|Placebo|
553565|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553566|NCT00630487|O1|Outcome|Placebo|
553567|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553568|NCT00630487|O1|Outcome|Placebo|
553569|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553570|NCT00630487|O1|Outcome|Placebo|
553571|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553572|NCT00630487|O1|Outcome|Placebo|
553573|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553574|NCT00630487|O1|Outcome|Placebo|
553575|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553576|NCT00630487|O1|Outcome|Placebo|
553577|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553578|NCT00630487|O1|Outcome|Placebo|
553579|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553580|NCT00630487|O1|Outcome|Placebo|
553581|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553582|NCT00630487|O1|Outcome|Placebo|
553583|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553584|NCT00630487|O1|Outcome|Placebo|
553585|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553586|NCT00630487|O1|Outcome|Placebo|
553587|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553588|NCT00630487|O1|Outcome|Placebo|
553589|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553590|NCT00630487|O1|Outcome|Placebo|
553591|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553592|NCT00630487|O1|Outcome|Placebo|
553593|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553594|NCT00630487|O1|Outcome|Placebo|
553622|NCT00630331|P2|Participant Flow|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553595|NCT00630487|E2|Reported Event|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
553596|NCT00630487|E1|Reported Event|Placebo|
553597|NCT00630409|B1|Baseline|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
553598|NCT00630409|P1|Participant Flow|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
553599|NCT00630409|O1|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8 + Doxil: 24 mg/m2 every 21 days IV"
553600|NCT00630409|O1|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
553601|NCT00630409|E1|Reported Event|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
553602|NCT00630396|B1|Baseline|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
553603|NCT00630396|P1|Participant Flow|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
553604|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
553605|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
553606|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
553607|NCT00630396|E1|Reported Event|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
553608|NCT00630344|B1|Baseline|RAD-001 in Combination With Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553609|NCT00630344|P1|Participant Flow|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553610|NCT00630344|O1|Outcome|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553611|NCT00630344|O1|Outcome|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553612|NCT00630344|O1|Outcome|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553613|NCT00630344|O1|Outcome|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553614|NCT00630344|O1|Outcome|RAD001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553615|NCT00630344|O1|Outcome|RAD-001 + Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553616|NCT00630344|E1|Reported Event|RAD-001+ Bicalutamide|"RAD001: once daily dose of 10 mg (5 mg tablets)~Bicalutamide: once daily dose of 50 mg (50 mg tablets)~1 cycle=28 days~Both agents are administered continuously until progression of disease or unacceptable toxicity."
553617|NCT00630331|B4|Baseline|Total|Total of all reporting groups
553618|NCT00630331|B3|Baseline|Placebo|One dose of phosphate buffered solution (PBS).
553619|NCT00630331|B2|Baseline|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553620|NCT00630331|B1|Baseline|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553806|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553625|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553626|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553627|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553628|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553629|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553630|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553631|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553632|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553633|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553634|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553635|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553636|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553637|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553638|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553639|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553640|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553641|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553642|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553643|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553644|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553645|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553646|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553647|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553648|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553649|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553650|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553651|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553652|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553653|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553654|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553655|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553656|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553657|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
553658|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553659|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553660|NCT00630331|E3|Reported Event|Placebo|One dose of phosphate buffered solution (PBS).
553661|NCT00630331|E2|Reported Event|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
553662|NCT00630331|E1|Reported Event|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
553663|NCT00630305|B1|Baseline|All Subjects|All subjects who were enrolled, randomized, and assigned to a study arm.
553664|NCT00630305|P1|Participant Flow|Overall|subjects were randomized to a session (A, B, C and D) and then to one of four lens sequences. Each subject participated in every session.
553665|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye.
553666|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
553667|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye.
553668|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye.
553669|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye.
553670|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
553671|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye.
553672|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye.
553673|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
553674|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
553675|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
553676|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
553677|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
553678|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
553679|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
553680|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
553807|NCT00629239|E2|Reported Event|Placebo|Placebo
553808|NCT00629239|E1|Reported Event|AZD4818|AZD4818 Turbuhaler
553681|NCT00630305|E4|Reported Event|Session D|"Closed eye session, this session includes the following sequences only:~senofilcon A/ lotrafilcon B~lotrafilcon B / senofilcon A~senofilcon A/ senofilcon A~lotrafilcon B / lotrafilcon B"
553682|NCT00630305|E3|Reported Event|Session C|"Open eye session, this session includes the following sequences only:~senofilcon A/ lotrafilcon B~lotrafilcon B / senofilcon A~senofilcon A/ senofilcon A~lotrafilcon B / lotrafilcon B"
553683|NCT00630305|E2|Reported Event|Session B|"Closed eye session, this session includes the following sequences only:~senofilcon A/ alphafilcon A~alphafilcon A/ senofilcon A~senofilcon A/ senofilcon A~alphafilcon A/ alphafilcon A"
553684|NCT00630305|E1|Reported Event|Session A|"Open eye session, this session includes the following sequences only:~senofilcon A / alphafilcon A~alphafilcon A / senofilcon A~senofilcon A / senofilcon A~alphafilcon A / alphafilcon A"
553685|NCT00630292|B1|Baseline|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
553686|NCT00630292|P1|Participant Flow|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
553687|NCT00630292|O1|Outcome|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
553688|NCT00630292|E1|Reported Event|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
553689|NCT00630058|B3|Baseline|Total|Total of all reporting groups
553690|NCT00630058|B2|Baseline|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553691|NCT00630058|B1|Baseline|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553692|NCT00630058|P2|Participant Flow|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553693|NCT00630058|P1|Participant Flow|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553694|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553695|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553696|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553697|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553698|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553699|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553700|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553701|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553702|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553703|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553704|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553705|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553706|NCT00630058|E2|Reported Event|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553707|NCT00630058|E1|Reported Event|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
553708|NCT00629850|B3|Baseline|Total|Total of all reporting groups
553709|NCT00629850|B2|Baseline|Control|This arm of the study will not receive the device.
553710|NCT00629850|B1|Baseline|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
553711|NCT00629850|P2|Participant Flow|Control|This arm of the study will not receive the device.
553712|NCT00629850|P1|Participant Flow|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
553713|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
553714|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
553715|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
553716|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
553717|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
553718|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
553719|NCT00629850|E2|Reported Event|Control|This arm of the study will not receive the device.
553720|NCT00629850|E1|Reported Event|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
553721|NCT00629772|B3|Baseline|Total|Total of all reporting groups
553722|NCT00629772|B2|Baseline|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553723|NCT00629772|B1|Baseline|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553724|NCT00629772|P2|Participant Flow|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553725|NCT00629772|P1|Participant Flow|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553726|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553727|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553728|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553729|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553730|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553731|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553732|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553733|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553734|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553735|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553736|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553737|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553738|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
553739|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553740|NCT00629772|E2|Reported Event|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
553741|NCT00629772|E1|Reported Event|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study.
553742|NCT00629707|B3|Baseline|Total|Total of all reporting groups
553743|NCT00629707|B2|Baseline|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
553744|NCT00629707|B1|Baseline|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
553745|NCT00629707|P2|Participant Flow|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
553746|NCT00629707|P1|Participant Flow|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
553747|NCT00629707|O2|Outcome|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
553748|NCT00629707|O1|Outcome|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
553749|NCT00629707|E2|Reported Event|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
553750|NCT00629707|E1|Reported Event|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
553751|NCT00629525|B1|Baseline|RAD001|RAD001 at a dose of 10 mg PO daily
553752|NCT00629525|P1|Participant Flow|RAD001|RAD001 at a dose of 10 mg PO daily
553753|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
553754|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
553755|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
553756|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
553757|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
553758|NCT00629525|E1|Reported Event|RAD001|RAD001 at a dose of 10 mg PO daily
553809|NCT00629122|B3|Baseline|Total|Total of all reporting groups
553810|NCT00629122|B2|Baseline|Arm B (Tacrolimus and Clotrimazole)|Sublingual (SL) tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553759|NCT00629499|B1|Baseline|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
553760|NCT00629499|P1|Participant Flow|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
553761|NCT00629499|O1|Outcome|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
553762|NCT00629499|E1|Reported Event|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
553763|NCT00629265|B3|Baseline|Total|Total of all reporting groups
553764|NCT00629265|B2|Baseline|Sham NMES Group|Sham NMES combined with exercise therapy
553765|NCT00629265|B1|Baseline|Active NMES Group|NMES therapy combined with exercise therapy
553766|NCT00629265|P2|Participant Flow|Sham NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553767|NCT00629265|P1|Participant Flow|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553768|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553769|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553770|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553771|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553772|NCT00629265|E2|Reported Event|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553773|NCT00629265|E1|Reported Event|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
553774|NCT00629239|B3|Baseline|Total|Total of all reporting groups
553775|NCT00629239|B2|Baseline|Placebo|Placebo
553776|NCT00629239|B1|Baseline|AZD4818|AZD4818 Turbuhaler
553777|NCT00629239|P2|Participant Flow|Placebo|Placebo
553778|NCT00629239|P1|Participant Flow|AZD4818|AZD4818 Turbuhaler
553779|NCT00629239|O2|Outcome|Placebo|Placebo
553780|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553781|NCT00629239|O2|Outcome|Placebo|Placebo
553782|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553783|NCT00629239|O2|Outcome|Placebo|Placebo
553784|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553785|NCT00629239|O2|Outcome|Placebo|Placebo
553786|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553787|NCT00629239|O2|Outcome|Placebo|Placebo
553788|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553789|NCT00629239|O2|Outcome|Placebo|Placebo
553790|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553791|NCT00629239|O2|Outcome|Placebo|Placebo
553792|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553793|NCT00629239|O2|Outcome|Placebo|Placebo
553794|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553795|NCT00629239|O2|Outcome|Placebo|Placebo
553796|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553797|NCT00629239|O2|Outcome|Placebo|Placebo
553798|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553799|NCT00629239|O2|Outcome|Placebo|Placebo
553800|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553801|NCT00629239|O2|Outcome|Placebo|Placebo
553802|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553803|NCT00629239|O2|Outcome|Placebo|Placebo
553804|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
553811|NCT00629122|B1|Baseline|Arm A (Tacrolimus and Nystatin)|Sublingual (SL) tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553812|NCT00629122|P2|Participant Flow|Arm B (Tacrolimus and Clotrimazole)|"Sublingual (SL) tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).~Study day 1: Initiate SL tacrolimus and clotrimazole troche x 5 doses. Study day 3: Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose.~Study day 3: Start washout period, no drug administration (tacrolimus, clotrimazole).~Study day 5: End washout period.~Study day 6: Initiate PO tacrolimus and clotrimazole troche x 5 doses. Study day 8: Collection of pharmacokinetic parameters around the 5th PO tacrolimus dose.~Study day 15: Participants will be contacted by telephone to assess for any adverse effects."
553813|NCT00629122|P1|Participant Flow|Arm A (Tacrolimus and Nystatin)|"Sublingual (SL) tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral (PO) tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).~Study day 1: Initiate SL tacrolimus and nystatin suspension x 5 doses. Study day 3: Collection of pharmacokinetic parameters around 5th SL tacrolimus dose.~Study day 3: Start washout period, no drug administration (tacrolimus, nystatin).~Study day 5: End washout period. Study day 6: Initiate PO tacrolimus and nystatin suspension x 5 doses. Study day 8: Collection of pharmacokinetic parameters around the 5th PO tacrolimus dose.~Study day 15: Participants will be contacted by telephone to assess for any adverse effects."
553814|NCT00629122|O2|Outcome|Arm B (Tacrolimus and Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553815|NCT00629122|O1|Outcome|Arm A (Tacrolimus and Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553816|NCT00629122|O2|Outcome|Arm B (Tacrolimus and Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553817|NCT00629122|O1|Outcome|Arm A (Tacrolimus and Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553818|NCT00629122|O2|Outcome|Arm B (Tacrolimus and Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553819|NCT00629122|O1|Outcome|Arm A (Tacrolimus and Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553820|NCT00629122|O2|Outcome|Arm B (Tacrolimus and Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553821|NCT00629122|O1|Outcome|Arm A (Tacrolimus and Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553822|NCT00629122|O2|Outcome|Arm B (Tacrolimus and Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553823|NCT00629122|O1|Outcome|Arm A (Tacrolimus and Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553824|NCT00629122|O2|Outcome|Arm B (Tacrolimus and Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553825|NCT00629122|O1|Outcome|Arm A (Tacrolimus and Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553826|NCT00629122|E2|Reported Event|Arm B (Tacrolimus + Clotrimazole)|Sublingual tacrolimus 1 mg every 12 hours (subject weight < 90 kg) or 2 mg every 12 hours (subject weight > 90 kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Clotrimazole troche 10 mg every 12 hours (study day 1 - 3 and 6 - 8).
553827|NCT00629122|E1|Reported Event|Arm A (Tacrolimus + Nystatin)|Sublingual tacrolimus 2 mg every 12 hours (subject weight < 90 kg) or 3 mg every 12 hours (subject weight > 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus capsules will be administered by mouth. Nystatin suspension 5 mL every 12 hours (study days 1 - 3 and 6 - 8).
553828|NCT00629018|B3|Baseline|Total|Total of all reporting groups
553829|NCT00629018|B2|Baseline|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
553830|NCT00629018|B1|Baseline|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
553831|NCT00629018|P2|Participant Flow|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
553832|NCT00629018|P1|Participant Flow|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
553833|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
553834|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
553835|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
553836|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
553837|NCT00629018|E2|Reported Event|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
553838|NCT00629018|E1|Reported Event|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
553839|NCT00628927|B3|Baseline|Total|Total of all reporting groups
553840|NCT00628927|B2|Baseline|Normal Control Participants|Normal Control participants recruited from the community
553841|NCT00628927|B1|Baseline|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
553842|NCT00628927|P2|Participant Flow|Normal Control Participants|Normal Control participants recruited from the community
553843|NCT00628927|P1|Participant Flow|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
553844|NCT00628927|O3|Outcome|Normal Controls|Normal controls recruited from the community.
553845|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for 2 participants who were ineligible but enrolled were removed from analysis 1 participant did not complete the blood draw~1 participant sample was insufficient for analysis"
553846|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week 3 participant samples were insufficient for analysis
553847|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data from the two ineligible by enrolled participants was removed from the analysis.~Data from 3 other participants was incomplete and therefore removed from the analysis."
553848|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week Data from one participant was excluded from analysis due to lack of completeness
553849|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for the two ineligible but enrolled participants was removed from the analysis.
553850|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week
553851|NCT00628927|E2|Reported Event|Normal Control Participants|Normal Control participants recruited from the community
553852|NCT00628927|E1|Reported Event|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
553853|NCT00628901|B3|Baseline|Total|Total of all reporting groups
553854|NCT00628901|B2|Baseline|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553855|NCT00628901|B1|Baseline|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553856|NCT00628901|P2|Participant Flow|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553857|NCT00628901|P1|Participant Flow|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553858|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553859|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553860|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553861|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553862|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553863|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553864|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553865|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553866|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553867|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553868|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553869|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553870|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553871|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553872|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553873|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553874|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553875|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553876|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553877|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553878|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553947|NCT00628758|E1|Reported Event|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
553879|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553880|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553881|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553882|NCT00628901|E2|Reported Event|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
553883|NCT00628901|E1|Reported Event|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
553884|NCT00628862|B4|Baseline|Total|Total of all reporting groups
553885|NCT00628862|B3|Baseline|Placebo|Placebo
553886|NCT00628862|B2|Baseline|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553887|NCT00628862|B1|Baseline|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553888|NCT00628862|P3|Participant Flow|Placebo|Placebo
553889|NCT00628862|P2|Participant Flow|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553890|NCT00628862|P1|Participant Flow|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553891|NCT00628862|O3|Outcome|Placebo|Placebo
553892|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553893|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553894|NCT00628862|O3|Outcome|Placebo|Placebo
553895|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553896|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553897|NCT00628862|O3|Outcome|Placebo|Placebo
553898|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553899|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553900|NCT00628862|O3|Outcome|Placebo|Placebo
553901|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553902|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553903|NCT00628862|O3|Outcome|Placebo|Placebo
553904|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553905|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553906|NCT00628862|O3|Outcome|Placebo|Placebo
553907|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553908|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553909|NCT00628862|O3|Outcome|Placebo|Placebo
553910|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553911|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553912|NCT00628862|O3|Outcome|Placebo|Placebo
553913|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553914|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553915|NCT00628862|O3|Outcome|Placebo|Placebo
553916|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553917|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553918|NCT00628862|O3|Outcome|Placebo|Placebo
553919|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553920|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553921|NCT00628862|O3|Outcome|Placebo|Placebo
553922|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553923|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553924|NCT00628862|O3|Outcome|Placebo|Placebo
553925|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553926|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553927|NCT00628862|O3|Outcome|Placebo|Placebo
553928|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553929|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553930|NCT00628862|E3|Reported Event|Placebo|Placebo
553931|NCT00628862|E2|Reported Event|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
553932|NCT00628862|E1|Reported Event|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
553933|NCT00628758|B3|Baseline|Total|Total of all reporting groups
553934|NCT00628758|B2|Baseline|Conventional BP|Conventional Best Practice for Treatment of asthma
553935|NCT00628758|B1|Baseline|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
553936|NCT00628758|P2|Participant Flow|Conventional BP|Conventional Best Practice for Treatment of asthma
553937|NCT00628758|P1|Participant Flow|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
553938|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
553939|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
553940|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
553941|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
553942|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
553943|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
553944|NCT00628758|O2|Outcome|Conventional Best Practice (BP)|Conventional Best Practice for Treatment of asthma
553945|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
553946|NCT00628758|E2|Reported Event|Conventional BP|Conventional Best Practice for Treatment of asthma
553948|NCT00628628|B3|Baseline|Total|Total of all reporting groups
553949|NCT00628628|B2|Baseline|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
553950|NCT00628628|B1|Baseline|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
553951|NCT00628628|P2|Participant Flow|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
553952|NCT00628628|P1|Participant Flow|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
553953|NCT00628628|O2|Outcome|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
553954|NCT00628628|O1|Outcome|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
553955|NCT00628628|E2|Reported Event|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
553956|NCT00628628|E1|Reported Event|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
553957|NCT00628589|B4|Baseline|Total|Total of all reporting groups
553958|NCT00628589|B3|Baseline|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
553959|NCT00628589|B2|Baseline|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
553960|NCT00628589|B1|Baseline|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
553961|NCT00628589|P3|Participant Flow|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
553962|NCT00628589|P2|Participant Flow|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
553963|NCT00628589|P1|Participant Flow|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
553964|NCT00628589|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
553965|NCT00628589|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
553966|NCT00628589|O1|Outcome|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
553967|NCT00628589|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
553968|NCT00628589|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
553969|NCT00628589|O1|Outcome|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
553970|NCT00628589|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
553971|NCT00628589|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
553972|NCT00628589|O1|Outcome|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
553973|NCT00628589|E3|Reported Event|Inhaled Loxapine 10 mg|Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
553974|NCT00628589|E2|Reported Event|Inhaled Loxapine 5 mg|Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
553975|NCT00628589|E1|Reported Event|Inhaled Placebo|Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
553976|NCT00628498|B1|Baseline|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
553977|NCT00628498|P1|Participant Flow|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
553978|NCT00628498|O1|Outcome|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
553979|NCT00628498|E1|Reported Event|Defibrotide|Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
553980|NCT00628446|B1|Baseline|Study Group|
553981|NCT00628446|P1|Participant Flow|Study Group|
553982|NCT00628446|O1|Outcome|Group 1|
553983|NCT00628446|O1|Outcome|Study Group|Cross-sectional study group
553984|NCT00628446|E1|Reported Event|Study Group|
553985|NCT00628407|B1|Baseline|Sternal Wall Pressure|
553986|NCT00628407|P1|Participant Flow|Sternal Wall Pressure|Subjects that received gentle incremental sternal wall pressure.
553987|NCT00628407|O1|Outcome|Sternal Wall Pressure|
553988|NCT00628407|E1|Reported Event|Sternal Wall Pressure|
553989|NCT00628355|B3|Baseline|Total|Total of all reporting groups
553990|NCT00628355|B2|Baseline|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
553991|NCT00628355|B1|Baseline|Ischemic Compression|Group received TENS plus Ischemic compression
553992|NCT00628355|P2|Participant Flow|Anesthesia Injection|Group received lidocaine injection
553993|NCT00628355|P1|Participant Flow|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
553994|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
553995|NCT00628355|O1|Outcome|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
553996|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
553997|NCT00628355|O1|Outcome|Ischemic Compression|Group received ischemic compression
553998|NCT00628355|E2|Reported Event|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
553999|NCT00628355|E1|Reported Event|Ischemic Compression|Group received Ischemic compression
554000|NCT00628251|B4|Baseline|Total|Total of all reporting groups
554001|NCT00628251|B3|Baseline|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554002|NCT00628251|B2|Baseline|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554003|NCT00628251|B1|Baseline|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554004|NCT00628251|P3|Participant Flow|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554005|NCT00628251|P2|Participant Flow|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554006|NCT00628251|P1|Participant Flow|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554007|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554008|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554009|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554010|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554011|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554012|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554013|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554014|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554015|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554016|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554017|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554018|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554019|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554020|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554021|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554022|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554023|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554024|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554025|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554026|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554027|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554028|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554029|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554030|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554031|NCT00628251|O4|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554032|NCT00628251|O3|Outcome|Olaparib 200 mg bd + Olaparib 400 mg bd,|Olaparib (AZD2281) 200 or 400 mg oral capsules twice daily
554033|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554034|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554035|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554036|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554037|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554038|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554039|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554040|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554041|NCT00628251|E3|Reported Event|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
554042|NCT00628251|E2|Reported Event|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
554043|NCT00628251|E1|Reported Event|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
554044|NCT00628212|B5|Baseline|Total|Total of all reporting groups
554045|NCT00628212|B4|Baseline|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
554046|NCT00628212|B3|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
554047|NCT00628212|B2|Baseline|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
554048|NCT00628212|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
554049|NCT00628212|P4|Participant Flow|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
554050|NCT00628212|P3|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
554051|NCT00628212|P2|Participant Flow|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
554052|NCT00628212|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
554053|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
554054|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
554055|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
554056|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
554057|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
554058|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
554059|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
554060|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
554061|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
554062|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
554063|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
554064|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
554065|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
554066|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
554067|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
554068|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
554069|NCT00628212|E4|Reported Event|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
554070|NCT00628212|E3|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
554071|NCT00628212|E2|Reported Event|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
554072|NCT00628212|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
554073|NCT00628147|B3|Baseline|Total|Total of all reporting groups
554074|NCT00628147|B2|Baseline|White Light|Conventional White Light Examination
554075|NCT00628147|B1|Baseline|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
554076|NCT00628147|P2|Participant Flow|White Light|Conventional White Light Examination
554077|NCT00628147|P1|Participant Flow|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
554078|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
554079|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
554080|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
554081|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
554082|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
554083|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
554084|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
554085|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
554086|NCT00628147|E2|Reported Event|White Light|Conventional White Light Examination
554087|NCT00628147|E1|Reported Event|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
554088|NCT00628134|B1|Baseline|Cystic Fibrosis Subjects|"Subjects with cystic fibrosis~isotonic saline aerosol : single inhaled dose, 3ml by nebulizer~calfactant aerosol : single inhaled dose, 3ml by nebulizer"
554089|NCT00628134|P2|Participant Flow|Saline Aerosol Then Surfactant Aerosol|cystic fibrosis patients who inhaled saline aerosol at the first study visit and surfactant aerosol at the second study visit
554090|NCT00628134|P1|Participant Flow|Surfactant Aerosol Then Saline Aerosol|cystic fibrosis patients who inhaled surfactant aerosol at the first study visit and saline aerosol at the second study visit
554091|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
554092|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
554093|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
554094|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
554095|NCT00628134|E2|Reported Event|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
554096|NCT00628134|E1|Reported Event|Subjects Inhaling Saline|Subjects with cystic fibrosis
554097|NCT00628108|B3|Baseline|Total|Total of all reporting groups
554098|NCT00628108|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554099|NCT00628108|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554100|NCT00628108|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554101|NCT00628108|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554102|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554103|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554104|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554105|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554242|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
554243|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
554106|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554107|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554108|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554109|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554110|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554111|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554112|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554113|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554114|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554115|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554116|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554117|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554118|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554119|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554120|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554121|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554122|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554123|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554124|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554125|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554126|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554127|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554128|NCT00628108|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554129|NCT00628108|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
554130|NCT00628030|B3|Baseline|Total|Total of all reporting groups
554131|NCT00628030|B2|Baseline|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
554162|NCT00627926|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554132|NCT00628030|B1|Baseline|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554133|NCT00628030|P2|Participant Flow|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
554134|NCT00628030|P1|Participant Flow|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554135|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
554136|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554137|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
554138|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554139|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
554140|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554141|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
554244|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
554245|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
554142|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554143|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
554144|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554145|NCT00628030|E2|Reported Event|Wellness Group|The placebo control group attended a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, parents received pedometers for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.Followed up for 6 months.
554146|NCT00628030|E1|Reported Event|NOURISH|The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. The interventions differed only in duration. They covered the same concepts which are grounded in Social Cognitive Theory (SCT). Throughout the interventions the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics provided information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
554147|NCT00627978|B3|Baseline|Total|Total of all reporting groups
554148|NCT00627978|B2|Baseline|Control|Participants receive no intervention.
554149|NCT00627978|B1|Baseline|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
554150|NCT00627978|P2|Participant Flow|Control|No treatment with Ixabepilone
554151|NCT00627978|P1|Participant Flow|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
554152|NCT00627978|O2|Outcome|Control|No treatment with Ixabepilone
554153|NCT00627978|O1|Outcome|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
554154|NCT00627978|E2|Reported Event|Control|Participants are not treated with Ixabepilone.
554155|NCT00627978|E1|Reported Event|Ixabepilone|"Participants are treated with Ixabepilone.~ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours"
554156|NCT00627926|B4|Baseline|Total|Total of all reporting groups
554157|NCT00627926|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554158|NCT00627926|B2|Baseline|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554159|NCT00627926|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554160|NCT00627926|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554161|NCT00627926|P2|Participant Flow|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554217|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554163|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554164|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554165|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554166|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554167|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554168|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554169|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554170|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554171|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554172|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554173|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554174|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554175|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554176|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554177|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554178|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
555474|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
554179|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554180|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554181|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554182|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554183|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554184|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554185|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554186|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554187|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554188|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554189|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554190|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554191|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554192|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554193|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554194|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554195|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554196|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554197|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554198|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554199|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554200|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554201|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554202|NCT00627926|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554203|NCT00627926|E2|Reported Event|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
554204|NCT00627926|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
554205|NCT00627861|B1|Baseline|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
554206|NCT00627861|P1|Participant Flow|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
554207|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks
554208|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks.
554209|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
554210|NCT00627861|E1|Reported Event|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
554211|NCT00627705|B3|Baseline|Total|Total of all reporting groups
554212|NCT00627705|B2|Baseline|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554213|NCT00627705|B1|Baseline|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554214|NCT00627705|P2|Participant Flow|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554215|NCT00627705|P1|Participant Flow|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554216|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
555681|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
554218|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554219|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554220|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554221|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554222|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554223|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554224|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554225|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554226|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554227|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554228|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554229|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554230|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554231|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554232|NCT00627705|E2|Reported Event|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554233|NCT00627705|E1|Reported Event|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
554234|NCT00627679|B1|Baseline|All Patients|All patients that were enrolled in the study.
554235|NCT00627679|P4|Participant Flow|Treatment D, A, C, B|Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
554236|NCT00627679|P3|Participant Flow|Treatment C, D, B, A|Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 5
554237|NCT00627679|P2|Participant Flow|Treatment B, C, A, D|Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
554238|NCT00627679|P1|Participant Flow|Treatment A, B, D, C|Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
554239|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
554240|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
554241|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
554246|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
554247|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
554248|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
554249|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
554250|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
554251|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
554252|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
554253|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
554254|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
554255|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
554256|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
554257|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
554258|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
554259|NCT00627679|E4|Reported Event|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
554260|NCT00627679|E3|Reported Event|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
554261|NCT00627679|E2|Reported Event|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
554262|NCT00627679|E1|Reported Event|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
554263|NCT00627523|B3|Baseline|Total|Total of all reporting groups
554264|NCT00627523|B2|Baseline|Control|This group was the untreated control group and was not administered placebo.
554265|NCT00627523|B1|Baseline|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554266|NCT00627523|P2|Participant Flow|Control|This group was the untreated control group and was not administered placebo.
554267|NCT00627523|P1|Participant Flow|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554268|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554269|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554270|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554271|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554272|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554273|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554274|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554275|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554276|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554277|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554278|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554279|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554280|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554320|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
556300|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
554281|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554282|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554283|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554284|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554285|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554286|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
554287|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554288|NCT00627523|E2|Reported Event|Control|This group was the untreated control group and was not administered placebo.
554289|NCT00627523|E1|Reported Event|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
554290|NCT00627497|B5|Baseline|Total|Total of all reporting groups
554291|NCT00627497|B4|Baseline|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554292|NCT00627497|B3|Baseline|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554293|NCT00627497|B2|Baseline|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554294|NCT00627497|B1|Baseline|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554295|NCT00627497|P4|Participant Flow|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554296|NCT00627497|P3|Participant Flow|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554297|NCT00627497|P2|Participant Flow|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554298|NCT00627497|P1|Participant Flow|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554299|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554300|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554301|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554302|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554303|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554304|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554305|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554306|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554307|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554308|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554309|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554310|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554311|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554312|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554313|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554314|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554315|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554316|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554317|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554318|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554319|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554321|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554322|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554323|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554324|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554325|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554326|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554327|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554328|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554329|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554330|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554331|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554332|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554333|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554334|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554335|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554336|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554337|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554338|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554339|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554340|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554341|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554342|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554343|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554344|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554345|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554346|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554347|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554348|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554349|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554350|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554351|NCT00627497|E4|Reported Event|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
554352|NCT00627497|E3|Reported Event|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554353|NCT00627497|E2|Reported Event|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
554354|NCT00627497|E1|Reported Event|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
554355|NCT00627458|B4|Baseline|Total|Total of all reporting groups
554356|NCT00627458|B3|Baseline|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554357|NCT00627458|B2|Baseline|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554358|NCT00627458|B1|Baseline|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554359|NCT00627458|P3|Participant Flow|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554455|NCT00627445|E1|Reported Event|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554360|NCT00627458|P2|Participant Flow|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554361|NCT00627458|P1|Participant Flow|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554362|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554363|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554364|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554365|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554366|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554367|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554368|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554369|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554370|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554371|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554372|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554373|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554374|NCT00627458|O3|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554375|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554376|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554456|NCT00627406|B5|Baseline|Total|Total of all reporting groups
556301|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
554377|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554378|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554379|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554380|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554381|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554382|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554383|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554384|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554385|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554386|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554387|NCT00627458|O1|Outcome|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554388|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554389|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554390|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554391|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554392|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554393|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554457|NCT00627406|B4|Baseline|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554394|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554395|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554396|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554397|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554398|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554399|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554400|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554401|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554402|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554403|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554404|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554405|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554406|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554407|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554408|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554409|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554410|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
556302|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
554411|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554412|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554413|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554414|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554415|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554416|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554417|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554418|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554419|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554420|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554421|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554422|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554423|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554424|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554425|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554426|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554427|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
556303|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
554428|NCT00627458|O2|Outcome|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554429|NCT00627458|O1|Outcome|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554430|NCT00627458|E3|Reported Event|Control Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554431|NCT00627458|E2|Reported Event|Infanrix Hexa PC Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554432|NCT00627458|E1|Reported Event|Infanrix Hexa PF Group|Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
554433|NCT00627445|B3|Baseline|Total|Total of all reporting groups
554434|NCT00627445|B2|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554435|NCT00627445|B1|Baseline|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554436|NCT00627445|P2|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554437|NCT00627445|P1|Participant Flow|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554438|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554439|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554440|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554441|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554442|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554443|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554444|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554445|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554446|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554447|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554448|NCT00627445|O2|Outcome|BIAsp 30-30|Individually adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin (500-2000 mg up to three times daily)
554449|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individually adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch in combination with metformin (500-2000 mg up to three times daily)
554450|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554451|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554452|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554453|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
554454|NCT00627445|E2|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
554458|NCT00627406|B3|Baseline|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
554459|NCT00627406|B2|Baseline|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554460|NCT00627406|B1|Baseline|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
554461|NCT00627406|P4|Participant Flow|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554462|NCT00627406|P3|Participant Flow|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
554463|NCT00627406|P2|Participant Flow|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554464|NCT00627406|P1|Participant Flow|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
554465|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554466|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
554467|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554468|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
554469|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554470|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
554471|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554472|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
554473|NCT00627406|E4|Reported Event|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554474|NCT00627406|E3|Reported Event|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
554475|NCT00627406|E2|Reported Event|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
554476|NCT00627406|E1|Reported Event|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
554477|NCT00627393|B3|Baseline|Total|Total of all reporting groups
554478|NCT00627393|B2|Baseline|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554479|NCT00627393|B1|Baseline|Control Arm|Received antimicrobial therapy alone.
554480|NCT00627393|P2|Participant Flow|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554481|NCT00627393|P1|Participant Flow|Control Arm|Received antimicrobial therapy alone.
554482|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone~G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.~Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
554483|NCT00627393|O1|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554484|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone~G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.~Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
554485|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554486|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
554487|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554488|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
554489|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554490|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
554491|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554492|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
554493|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554494|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
554495|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554496|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
554497|NCT00627393|E2|Reported Event|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
554498|NCT00627393|E1|Reported Event|Control Arm|Received antimicrobial therapy alone.
554499|NCT00627367|B3|Baseline|Total|Total of all reporting groups
554500|NCT00627367|B2|Baseline|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
554501|NCT00627367|B1|Baseline|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
554502|NCT00627367|P2|Participant Flow|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
554503|NCT00627367|P1|Participant Flow|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
554504|NCT00627367|O2|Outcome|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician. For this subanalysis, only patients who received IV morphine are analyzed"
554505|NCT00627367|O1|Outcome|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
554506|NCT00627367|O2|Outcome|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
554507|NCT00627367|O1|Outcome|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
554508|NCT00627367|O2|Outcome|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
554509|NCT00627367|O1|Outcome|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
554510|NCT00627367|O2|Outcome|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
554511|NCT00627367|O1|Outcome|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
554512|NCT00627367|E2|Reported Event|Nonprotocolized|"An IV opioid the type and dose of which will be determined by the treating clincian~Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician"
554513|NCT00627367|E1|Reported Event|Protocolized|"1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer yes to the question, Do you want more pain medication?~Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes"
554514|NCT00627094|B3|Baseline|Total|Total of all reporting groups
554515|NCT00627094|B2|Baseline|Biatain|Biatain foam dressing without ibuprofen - control
554516|NCT00627094|B1|Baseline|Biatain Ibu|Biatain foam dressing containing ibuprofen
554517|NCT00627094|P2|Participant Flow|Biatain|Biatain Foam dressing without ibuprofen - control
554518|NCT00627094|P1|Participant Flow|Biatain Ibu|Biatain foam dressing containing Ibuprofen
554519|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
554520|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
554521|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
554522|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
554523|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
554524|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
554525|NCT00627094|O2|Outcome|Biatain|Biatain foam dressing without ibuprofen - control
554526|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing ibuprofen
554527|NCT00627094|E2|Reported Event|Biatain|Biatain foam dressing without ibuprofen
554528|NCT00627094|E1|Reported Event|Biatain Ibu|Biatain foam dressing containing ibuprofen
554529|NCT00627042|B1|Baseline|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554530|NCT00627042|P1|Participant Flow|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554531|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554532|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554533|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554534|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554535|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554536|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554537|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554538|NCT00627042|E1|Reported Event|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
554539|NCT00627016|B3|Baseline|Total|Total of all reporting groups
554540|NCT00627016|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
554541|NCT00627016|B1|Baseline|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
554542|NCT00627016|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
554543|NCT00627016|P1|Participant Flow|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
554544|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
554545|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
554546|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
554547|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
554548|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
554549|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
554550|NCT00627016|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
554551|NCT00627016|E1|Reported Event|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
554552|NCT00626925|B3|Baseline|Total|Total of all reporting groups
554553|NCT00626925|B2|Baseline|Total Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554554|NCT00626925|B1|Baseline|Total Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554555|NCT00626925|P2|Participant Flow|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554556|NCT00626925|P1|Participant Flow|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554557|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554558|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554559|NCT00626925|O2|Outcome|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554560|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554561|NCT00626925|O2|Outcome|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554562|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554563|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554564|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554565|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554566|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554567|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554568|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554569|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554570|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554571|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554572|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554573|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554574|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554575|NCT00626925|O6|Outcome|6 Month Post Treatment Placebo Group|Mean Standard Drinks Per Day, 6 months post treatment
554576|NCT00626925|O5|Outcome|6 Month Post Treatment Topiramate Group|Mean Standard Drinks Per Day, 6 months post treatment
554577|NCT00626925|O4|Outcome|3 Month Post Treatment Placebo Group|Mean Standard Drinks Per Day, 3 months post treatment
554578|NCT00626925|O3|Outcome|3 Month Post Treatment Topiramate Group|Mean Standard Drinks Per Day, 3 months post treatment
554579|NCT00626925|O2|Outcome|Total Placebo Group|"Inactive placebo matched in appearance with topiramate capsules~Placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554580|NCT00626925|O1|Outcome|Total Topiramate Group|"Topiramate capsules beginning at 25 mg/day with gradual increase to a maximum of 200 mg orally)~Topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554581|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554582|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554583|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554584|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554585|NCT00626925|E2|Reported Event|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554586|NCT00626925|E1|Reported Event|Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
554587|NCT00626821|B1|Baseline|SenSura|Test of SenSura for 6-8 weeks
554588|NCT00626821|P1|Participant Flow|SenSura|Test of SenSura for 6-8 weeks
554589|NCT00626821|O1|Outcome|SenSura|Participants tested SenSura for 6-8 weeks. Baseline data were informations about pre-study product.
554590|NCT00626821|E1|Reported Event|SenSura|Test of SenSura for 6-8 weeks
554591|NCT00626808|B5|Baseline|Total|Total of all reporting groups
554592|NCT00626808|B4|Baseline|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554593|NCT00626808|B3|Baseline|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554594|NCT00626808|B2|Baseline|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554595|NCT00626808|B1|Baseline|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554596|NCT00626808|P4|Participant Flow|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
556054|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
554597|NCT00626808|P3|Participant Flow|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554598|NCT00626808|P2|Participant Flow|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554599|NCT00626808|P1|Participant Flow|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554600|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554601|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554602|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554603|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554604|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554605|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554606|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554607|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554608|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554609|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554610|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554611|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554612|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554613|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554614|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554615|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554616|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554617|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554618|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554619|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554620|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554621|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554622|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554623|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554624|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554625|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554626|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554627|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554628|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554629|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554630|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554631|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554632|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554633|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554634|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554635|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554636|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554637|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554638|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554639|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554640|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554641|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554642|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554643|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554644|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554645|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554646|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554647|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554648|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554649|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554650|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554651|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554652|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554653|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554654|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554655|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554656|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554657|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554658|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
554659|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554660|NCT00626808|E4|Reported Event|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
554661|NCT00626808|E3|Reported Event|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
554662|NCT00626808|E2|Reported Event|Children 24-59 Months With Asthma|
554663|NCT00626808|E1|Reported Event|Participants Less Than 24 Months of Age|Participants less than 24 months of age
554664|NCT00626782|B3|Baseline|Total|Total of all reporting groups
554665|NCT00626782|B2|Baseline|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
554666|NCT00626782|B1|Baseline|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
554667|NCT00626782|P2|Participant Flow|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
554668|NCT00626782|P1|Participant Flow|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
554669|NCT00626782|O2|Outcome|B: Mitomycin C 0.4 mg/ml Sponge|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.~Mitomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
554670|NCT00626782|O1|Outcome|A: Ranibizumab 0.5mg (0.05mL) Injection|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
554671|NCT00626782|O2|Outcome|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
554672|NCT00626782|O1|Outcome|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
554673|NCT00626782|E2|Reported Event|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
554674|NCT00626782|E1|Reported Event|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
554675|NCT00626743|B3|Baseline|Total|Total of all reporting groups
554676|NCT00626743|B2|Baseline|Asan Medical Center|
554677|NCT00626743|B1|Baseline|INJE University Pusan Paik Hospital|
554678|NCT00626743|P2|Participant Flow|Placebo|"Tablet which has the same appearance and taste but doesn’t contain active ingredient~SK3530 100mg, Placebo, Amlodipine"
554679|NCT00626743|P1|Participant Flow|SK3530|"Active Drug~SK3530 100mg, Placebo, Amlodipine"
554680|NCT00626743|O2|Outcome|Amlodipine + Placebo|
554681|NCT00626743|O1|Outcome|Amlodipine + SK3530|
554682|NCT00626743|O2|Outcome|Amlodipine + Placebo|
554683|NCT00626743|O1|Outcome|Amlodipine + SK3530|
554684|NCT00626743|E2|Reported Event|Amlodipine + Placebo|
554685|NCT00626743|E1|Reported Event|Amlodipine + SK3530|
554686|NCT00626639|B3|Baseline|Total|Total of all reporting groups
554687|NCT00626639|B2|Baseline|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554688|NCT00626639|B1|Baseline|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554689|NCT00626639|P2|Participant Flow|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554690|NCT00626639|P1|Participant Flow|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554691|NCT00626639|O2|Outcome|Palifermin|Subjects who received Palifermin during the acute phase of the study.
554692|NCT00626639|O1|Outcome|Placebo|Subjects who received placebo during the acute phase of the study.
554762|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554763|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
554764|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554693|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554694|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554695|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554696|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554697|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554698|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554699|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554700|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554701|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554702|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554703|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554704|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554705|NCT00626639|E2|Reported Event|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554706|NCT00626639|E1|Reported Event|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
554707|NCT00626626|B3|Baseline|Total|Total of all reporting groups
554708|NCT00626626|B2|Baseline|Dose Level 2|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
554709|NCT00626626|B1|Baseline|Dose Level1|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
554710|NCT00626626|P2|Participant Flow|"Clofar, Cyclophos,Alemtuzumab(Ph II)"|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
554711|NCT00626626|P1|Participant Flow|"Clofar, Cyclophos, Alemtuzumab"|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
554712|NCT00626626|O2|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
554713|NCT00626626|O1|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
554714|NCT00626626|O2|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
554715|NCT00626626|O1|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
554716|NCT00626626|O2|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
554717|NCT00626626|O1|Outcome|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I )|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
554765|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554766|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554767|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
556304|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
554718|NCT00626626|E2|Reported Event|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase II)|"Phase II patients 4-9 will treat at the selected dose level of Clofarabine and Cyclophosphamide.~Dose Level 2: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 1000 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion (patients 4-9)"
554719|NCT00626626|E1|Reported Event|Clofarabine, Cyclophosphamide & Alemtuzumab (Phase I)|"Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy.~Dose Level I: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion. Alemtuzumab on day -8 only and after Clofarabine. Cyclophosphamide 500 mg/m2 Days -8 and -7 (2 doses) given over 1 hour beginning 4 hours after the beginning of Clofarabine infusion."
554720|NCT00626574|B3|Baseline|Total|Total of all reporting groups
554721|NCT00626574|B2|Baseline|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
554722|NCT00626574|B1|Baseline|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
554723|NCT00626574|P2|Participant Flow|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
554724|NCT00626574|P1|Participant Flow|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
554725|NCT00626574|O2|Outcome|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
554726|NCT00626574|O1|Outcome|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
554727|NCT00626574|E2|Reported Event|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
554728|NCT00626574|E1|Reported Event|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
554729|NCT00626561|B1|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
554730|NCT00626561|P1|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
554731|NCT00626561|O1|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
554732|NCT00626561|E1|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
554733|NCT00626548|B3|Baseline|Total|Total of all reporting groups
554734|NCT00626548|B2|Baseline|Placebo|Placebo oral tablet once daily
554735|NCT00626548|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
554736|NCT00626548|P2|Participant Flow|Placebo|Placebo oral tablet once daily
554737|NCT00626548|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
554738|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
554739|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
554740|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
554741|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
554742|NCT00626548|E2|Reported Event|Placebo|Placebo oral tablet once daily
554743|NCT00626548|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
554744|NCT00626522|B7|Baseline|Total|Total of all reporting groups
554745|NCT00626522|B6|Baseline|Placebo|Placebo once-daily
554746|NCT00626522|B5|Baseline|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554747|NCT00626522|B4|Baseline|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554748|NCT00626522|B3|Baseline|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554749|NCT00626522|B2|Baseline|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
554750|NCT00626522|B1|Baseline|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554751|NCT00626522|P6|Participant Flow|Placebo|Placebo once-daily
554752|NCT00626522|P5|Participant Flow|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554753|NCT00626522|P4|Participant Flow|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554754|NCT00626522|P3|Participant Flow|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554755|NCT00626522|P2|Participant Flow|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
554756|NCT00626522|P1|Participant Flow|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554757|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
554758|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554759|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554760|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554761|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
554768|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554769|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
554770|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554771|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554772|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554773|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
554774|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554775|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
554776|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554777|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554778|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554779|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
554780|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554781|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
554782|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554783|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554784|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554785|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
554786|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554787|NCT00626522|E6|Reported Event|Placebo|Placebo once-daily
554788|NCT00626522|E5|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
554789|NCT00626522|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
554790|NCT00626522|E3|Reported Event|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
554791|NCT00626522|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
554792|NCT00626522|E1|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
554793|NCT00626444|B1|Baseline|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
554794|NCT00626444|P1|Participant Flow|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
554795|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
554796|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
554797|NCT00626444|E1|Reported Event|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
554798|NCT00626431|B3|Baseline|Total|Total of all reporting groups
554799|NCT00626431|B2|Baseline|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554800|NCT00626431|B1|Baseline|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554801|NCT00626431|P2|Participant Flow|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554802|NCT00626431|P1|Participant Flow|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554803|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554804|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554805|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554806|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554807|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554808|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554809|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554810|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554811|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554812|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554813|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554814|NCT00626431|E2|Reported Event|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554815|NCT00626431|E1|Reported Event|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
554816|NCT00626405|B3|Baseline|Total|Total of all reporting groups
554817|NCT00626405|B2|Baseline|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. >~> bevacizumab: Given IV over 30-90 minutes >~> carboplatin: Given IV over 30 minutes >~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
554818|NCT00626405|B1|Baseline|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. > > bevacizumab: Given IV over 30-90 minutes >~> temozolomide: Oral temozolomide on days 1-5"
554819|NCT00626405|P2|Participant Flow|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. >~> bevacizumab: Given IV over 30-90 minutes >~> carboplatin: Given IV over 30 minutes >~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
554820|NCT00626405|P1|Participant Flow|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. > > bevacizumab: Given IV over 30-90 minutes >~> temozolomide: Oral temozolomide on days 1-5"
554821|NCT00626405|O2|Outcome|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.~>~> bevacizumab: Given IV over 30-90 minutes~>~> carboplatin: Given IV over 30 minutes~>~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
554822|NCT00626405|O1|Outcome|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.~>~> bevacizumab: Given IV over 30-90 minutes~>~> temozolomide: Oral temozolomide on days 1-5"
554823|NCT00626405|O2|Outcome|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.~>~> bevacizumab: Given IV over 30-90 minutes~>~> carboplatin: Given IV over 30 minutes~>~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
554824|NCT00626405|O1|Outcome|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.~>~> bevacizumab: Given IV over 30-90 minutes~>~> temozolomide: Oral temozolomide on days 1-5"
554825|NCT00626405|O2|Outcome|Arm II|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.~>~> bevacizumab: Given IV over 30-90 minutes~>~> carboplatin: Given IV over 30 minutes~>~> paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes"
554826|NCT00626405|O1|Outcome|Arm I|"Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.~>~> bevacizumab: Given IV over 30-90 minutes~>~> temozolomide: Oral temozolomide on days 1-5"
554827|NCT00626405|E2|Reported Event|Arm II|paclitaxel albumin-stabilized nanoparticle formulation: Given IV over 30 minutes
554828|NCT00626405|E1|Reported Event|Arm I|temozolomide: Oral temozolomide on days 1-5
554829|NCT00626392|B7|Baseline|Total|Total of all reporting groups
554830|NCT00626392|B6|Baseline|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
556305|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
554831|NCT00626392|B5|Baseline|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
554832|NCT00626392|B4|Baseline|NER 1000; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
554833|NCT00626392|B3|Baseline|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
554834|NCT00626392|B2|Baseline|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
554835|NCT00626392|B1|Baseline|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
554836|NCT00626392|P6|Participant Flow|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
554837|NCT00626392|P5|Participant Flow|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
554838|NCT00626392|P4|Participant Flow|NER 1000; ASA run-in; ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
554839|NCT00626392|P3|Participant Flow|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
554840|NCT00626392|P2|Participant Flow|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
554841|NCT00626392|P1|Participant Flow|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
554842|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
554843|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
554844|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
554845|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
554846|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
554847|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
554848|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
554849|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
554850|NCT00626392|E2|Reported Event|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
554851|NCT00626392|E1|Reported Event|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
554852|NCT00626340|B1|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
554853|NCT00626340|P1|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
554854|NCT00626340|O1|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
554855|NCT00626340|E1|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
554856|NCT00626327|B4|Baseline|Total|Total of all reporting groups
554857|NCT00626327|B3|Baseline|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
554858|NCT00626327|B2|Baseline|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554859|NCT00626327|B1|Baseline|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554860|NCT00626327|P3|Participant Flow|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
554861|NCT00626327|P2|Participant Flow|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554862|NCT00626327|P1|Participant Flow|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554863|NCT00626327|O3|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
554864|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554865|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554866|NCT00626327|O3|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554867|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
554868|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554869|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
554870|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
554871|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554872|NCT00626327|O1|Outcome|MenACWY-CRM +MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554873|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554874|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554875|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
554876|NCT00626327|O1|Outcome|MenACWY-CRM + MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554877|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
554878|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554879|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
554880|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
554881|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554882|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554883|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554884|NCT00626327|E3|Reported Event|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
554885|NCT00626327|E2|Reported Event|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
554886|NCT00626327|E1|Reported Event|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
554887|NCT00626275|B1|Baseline|All Treated Participants|All participants who received at least 1 dose of study drug during any sequence of Part A of the study. Baseline measures reported in aggregate for all participants to avoid double counting of Parts A and B.
554888|NCT00626275|P8|Participant Flow|Part B: Placebo|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554889|NCT00626275|P7|Participant Flow|Part B: ADL5859 100 mg|ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study
554890|NCT00626275|P6|Participant Flow|Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then placebo, then naproxen 500 mg).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose."
554891|NCT00626275|P5|Participant Flow|Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then naproxen 500 mg, then ADL5859 200 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
554923|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554924|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
556083|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
554892|NCT00626275|P4|Participant Flow|Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then ADL5859 200 mg, then placebo).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
554893|NCT00626275|P3|Participant Flow|Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then placebo, then ADL5859 200 mg).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
554894|NCT00626275|P2|Participant Flow|Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then naproxen 500 mg, then placebo).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
554895|NCT00626275|P1|Participant Flow|Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then ADL5859 200 milligrams (mg), then naproxen 500 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose"
554896|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
554897|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554898|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554899|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554900|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554901|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
554902|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554903|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
554904|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554905|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
554906|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554907|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
554908|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554909|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554910|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554911|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554912|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554913|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554914|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554915|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554916|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554917|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554918|NCT00626275|O3|Outcome|ADL5859 - 200mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554919|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554920|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554921|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
554922|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554925|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554926|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554927|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554928|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554929|NCT00626275|E5|Reported Event|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
554930|NCT00626275|E4|Reported Event|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
554931|NCT00626275|E3|Reported Event|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554932|NCT00626275|E2|Reported Event|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
554933|NCT00626275|E1|Reported Event|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
554934|NCT00626210|B1|Baseline|Modafinil|Open label study in which all participants get modafinil
554935|NCT00626210|P1|Participant Flow|Modafinil|daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
554936|NCT00626210|O1|Outcome|Modafinil|
554937|NCT00626210|E1|Reported Event|Modafinil|
554938|NCT00626093|B1|Baseline|Group 1|
554939|NCT00626093|P1|Participant Flow|Cardiac Resynchronization Therapy - Defibrillators (CRT-D)|All patients enrolled were indicated for a CRT-D.
554940|NCT00626093|O1|Outcome|CRT-D|
554941|NCT00626093|O1|Outcome|CRT-D|
554942|NCT00626093|E1|Reported Event|Group 1|
554943|NCT00626028|B3|Baseline|Total|Total of all reporting groups
554944|NCT00626028|B2|Baseline|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
554945|NCT00626028|B1|Baseline|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
554946|NCT00626028|P2|Participant Flow|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
554947|NCT00626028|P1|Participant Flow|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
554948|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
554949|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
554950|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
554951|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
554952|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
554953|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
554954|NCT00626028|E2|Reported Event|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
554955|NCT00626028|E1|Reported Event|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
554956|NCT00625989|B1|Baseline|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
554957|NCT00625989|P2|Participant Flow|Allergen Then Diluent Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, dilluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
554958|NCT00625989|P1|Participant Flow|Diluent Then Allergen Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 diluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
554959|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
554960|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
554961|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
554962|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
554963|NCT00625989|E1|Reported Event|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
554964|NCT00625872|B3|Baseline|Total|Total of all reporting groups
554965|NCT00625872|B2|Baseline|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554966|NCT00625872|B1|Baseline|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554967|NCT00625872|P2|Participant Flow|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554968|NCT00625872|P1|Participant Flow|Somatropin|Somatropin 0.035 milligram/kilogram/day (mg/kg/day) was administered subcutaneously (s.c) according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554969|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554970|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554971|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554972|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554973|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554974|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554975|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554976|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554977|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554978|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554979|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554980|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554981|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554982|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554983|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554984|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554985|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554986|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554987|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554988|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554989|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554990|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554991|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554992|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554993|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554994|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554995|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554996|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554997|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
554998|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
554999|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555000|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555001|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555002|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555003|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555004|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555005|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555006|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555007|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555008|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555009|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555010|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555011|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555012|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555013|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555014|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555015|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555016|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555017|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555018|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555019|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555020|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555021|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555022|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555023|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555024|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555025|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555026|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555027|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555028|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555029|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555030|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555031|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555032|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555033|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555034|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555035|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555036|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555037|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555038|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555039|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555040|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555041|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555042|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555043|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555044|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555045|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555046|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555047|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555048|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555049|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555050|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555051|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555052|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555053|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555054|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555055|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555056|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555057|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555058|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555059|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555060|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555061|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555062|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555063|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555064|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555065|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555066|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555067|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555068|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555069|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555070|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555071|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555072|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555073|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555074|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555075|NCT00625872|E2|Reported Event|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
555076|NCT00625872|E1|Reported Event|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
555077|NCT00625820|B1|Baseline|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
555078|NCT00625820|P1|Participant Flow|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
555079|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
555080|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
555081|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|
555082|NCT00625820|E1|Reported Event|BH4, BH4 + Vit C|
555083|NCT00625742|B1|Baseline|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
555084|NCT00625742|P1|Participant Flow|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
555085|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
555086|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
555087|NCT00625742|E1|Reported Event|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
555088|NCT00625729|B1|Baseline|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555089|NCT00625729|P1|Participant Flow|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555090|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555091|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555092|NCT00625729|O1|Outcome|Responder Patients|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy who had a response to treatment (clinical response or partial response).
555160|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555093|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555094|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555095|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555096|NCT00625729|E1|Reported Event|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
555097|NCT00625586|B1|Baseline|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555098|NCT00625586|P1|Participant Flow|RAV12 Plus Gemcitabine|RAV12 monoclonal antibody plus gemcitabine
555099|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555100|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555101|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555102|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555103|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555104|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555105|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555106|NCT00625586|E1|Reported Event|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
555107|NCT00625443|B4|Baseline|Total|Total of all reporting groups
555108|NCT00625443|B3|Baseline|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555109|NCT00625443|B2|Baseline|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555110|NCT00625443|B1|Baseline|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555111|NCT00625443|P3|Participant Flow|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555112|NCT00625443|P2|Participant Flow|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555113|NCT00625443|P1|Participant Flow|Lower 1/3 Avatromboopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555114|NCT00625443|O2|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555131|NCT00625443|O3|Outcome|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555115|NCT00625443|O1|Outcome|Responders|Participants continued on their previous blinded dose in study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555116|NCT00625443|O2|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555117|NCT00625443|O1|Outcome|Responders|Participants continued on their previous blinded dose in study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555118|NCT00625443|O2|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555119|NCT00625443|O1|Outcome|Responders|Participants continued on their previous blinded dose in study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555120|NCT00625443|O2|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555121|NCT00625443|O1|Outcome|Responders|Participants continued on their previous blinded dose study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555122|NCT00625443|O2|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555123|NCT00625443|O1|Outcome|Responders|Participants continued on their previous blinded dose in study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555124|NCT00625443|O2|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555125|NCT00625443|O1|Outcome|Responders|Participants continued on their previous blinded dose in study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555126|NCT00625443|O2|Outcome|Nonresponders|Participants began treatment with open-label 10 mg avatrombopag daily. The maximum possible escalated dose was 40 mg/day open-label. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555127|NCT00625443|O1|Outcome|Responders|Participants continued on their previous blinded dose in study 501-CL-003 at entry into this study. These blinded doses were: avatrombopag 2.5 mg, 5 mg, 10 mg, and 20 mg. The maximum possible escalated dose was a total dose of assigned double-blind avatrombopag plus an additional 20 mg/day open-label avatrombopag. Grouping Method B of dividing participants into Responders and Non-Responders was based on both treatment received and Day 28 platelet response to study drug in study 501-CL-004.
555128|NCT00625443|O3|Outcome|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555129|NCT00625443|O2|Outcome|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555130|NCT00625443|O1|Outcome|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555159|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
556306|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
555132|NCT00625443|O2|Outcome|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555133|NCT00625443|O1|Outcome|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555134|NCT00625443|O3|Outcome|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555135|NCT00625443|O2|Outcome|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555136|NCT00625443|O1|Outcome|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555137|NCT00625443|E3|Reported Event|Upper 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555138|NCT00625443|E2|Reported Event|Middle 1/3 Avatrombopag Dose Group|Participants in this group took greater than or equal to 8.85 mg avatrombopag to less than 13.5 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555139|NCT00625443|E1|Reported Event|Lower 1/3 Avatrombopag Dose Group|Participants in this group took less than 8.85 mg avatrombopag orally once daily under fasting conditions (at least 1 hour before and 2 hours after a meal or snack). Grouping Method A of avatrombopag dose into lower 1/3, middle 1/3, and upper 1/3 was based on the average daily dose received during the combined active treatment periods of studies 501-CL-003 and 501-CL-004.
555140|NCT00625404|B3|Baseline|Total|Total of all reporting groups
555141|NCT00625404|B2|Baseline|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555142|NCT00625404|B1|Baseline|Truvada Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555143|NCT00625404|P2|Participant Flow|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555144|NCT00625404|P1|Participant Flow|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555145|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555146|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555147|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555148|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555149|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555150|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555151|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555152|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555153|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555154|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555155|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555156|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555157|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555158|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
556307|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
555161|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555162|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555163|NCT00625404|O2|Outcome|Placebo Arm|The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.
555164|NCT00625404|O1|Outcome|Truvada Arm|The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.
555165|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555166|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555167|NCT00625404|O2|Outcome|Placebo Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
555168|NCT00625404|O1|Outcome|Truvada Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
555169|NCT00625404|E2|Reported Event|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
555170|NCT00625404|E1|Reported Event|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
555171|NCT00625391|B5|Baseline|Total|Total of all reporting groups
555172|NCT00625391|B4|Baseline|GTP+Tai Chi|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
555173|NCT00625391|B3|Baseline|Placebo+Tai Chi|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
555174|NCT00625391|B2|Baseline|Green Tea Polyphenols (GTP)|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
555175|NCT00625391|B1|Baseline|Placebo|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
555176|NCT00625391|P4|Participant Flow|GTP + Tai Chi Group|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
555177|NCT00625391|P3|Participant Flow|Placebo + Tai Chi Group|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
555178|NCT00625391|P2|Participant Flow|Green Tea Polyphenols (GTP) Group|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
555179|NCT00625391|P1|Participant Flow|Placebo Group|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
555180|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
555181|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
555182|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
555183|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.~Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.~placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.~GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
555184|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
555185|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
555186|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
555187|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.~Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.~placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.~GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
555188|NCT00625391|E4|Reported Event|GTP+TC|Green tea polyphenols at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
555189|NCT00625391|E3|Reported Event|Placebo+Tai Chi (TC)|Medicinal starch at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
555190|NCT00625391|E2|Reported Event|Green Tea Polyphenols (GTP)|Green tea polyphenols at 500 mg daily for 24 weeks
555191|NCT00625391|E1|Reported Event|Placebo|Medicinal starch at 500 mg daily for 24 weeks
555192|NCT00625365|B1|Baseline|DEFINITY (Perflutren Lipid Microsphere)|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
555193|NCT00625365|P1|Participant Flow|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
555194|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
555195|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
555196|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
555197|NCT00625365|E1|Reported Event|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
555198|NCT00625183|B1|Baseline|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555199|NCT00625183|P1|Participant Flow|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555200|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine,Radiation Therapy|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555201|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555202|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine,Radiation Therapy|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555203|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555204|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555205|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555206|NCT00625183|E1|Reported Event|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
555207|NCT00625131|B3|Baseline|Total|Total of all reporting groups
555208|NCT00625131|B2|Baseline|Arm 2|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555209|NCT00625131|B1|Baseline|Arm 1|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555210|NCT00625131|P3|Participant Flow|Not Randomized|This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization.
555211|NCT00625131|P2|Participant Flow|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555212|NCT00625131|P1|Participant Flow|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555213|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555214|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555215|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555216|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555217|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555218|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555219|NCT00625131|E2|Reported Event|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555220|NCT00625131|E1|Reported Event|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
555221|NCT00624923|B3|Baseline|Total|Total of all reporting groups
555222|NCT00624923|B2|Baseline|2- Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
555223|NCT00624923|B1|Baseline|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
555224|NCT00624923|P2|Participant Flow|2- Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
555225|NCT00624923|P1|Participant Flow|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
555226|NCT00624923|O2|Outcome|2-Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
555227|NCT00624923|O1|Outcome|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
555228|NCT00624923|E2|Reported Event|2- Placebo|"Placebo~Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months"
555229|NCT00624923|E1|Reported Event|1- Active Pharmacologic|"Salsalate~Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months"
555230|NCT00624832|B5|Baseline|Total|Total of all reporting groups
555231|NCT00624832|B4|Baseline|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
555232|NCT00624832|B3|Baseline|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555233|NCT00624832|B2|Baseline|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555234|NCT00624832|B1|Baseline|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
555235|NCT00624832|P4|Participant Flow|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
555236|NCT00624832|P3|Participant Flow|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555237|NCT00624832|P2|Participant Flow|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555238|NCT00624832|P1|Participant Flow|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
555239|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
555240|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555241|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
555242|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
555243|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555244|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
555245|NCT00624832|E4|Reported Event|Placebo Comparator|Placebo comparator
555246|NCT00624832|E3|Reported Event|Xolair (IgE= 301- 699 IU/mL)|Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555247|NCT00624832|E2|Reported Event|Xolair (IgE= 700- 2000 IU/mL)|Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
555248|NCT00624832|E1|Reported Event|Xolair (IgE= 30- 300 IU/mL)|Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
555249|NCT00624806|B3|Baseline|Total|Total of all reporting groups
555250|NCT00624806|B2|Baseline|Weekly Group|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
555251|NCT00624806|B1|Baseline|Daily Group|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
555252|NCT00624806|P2|Participant Flow|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
555682|NCT00624065|E2|Reported Event|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
555253|NCT00624806|P1|Participant Flow|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
555254|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
555255|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
555256|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
555257|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
555258|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
555259|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
555260|NCT00624806|E2|Reported Event|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
555261|NCT00624806|E1|Reported Event|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
555262|NCT00624780|B7|Baseline|Total|Total of all reporting groups
555263|NCT00624780|B6|Baseline|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555264|NCT00624780|B5|Baseline|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555265|NCT00624780|B4|Baseline|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555266|NCT00624780|B3|Baseline|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555267|NCT00624780|B2|Baseline|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555339|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555268|NCT00624780|B1|Baseline|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555269|NCT00624780|P6|Participant Flow|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555270|NCT00624780|P5|Participant Flow|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555271|NCT00624780|P4|Participant Flow|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555272|NCT00624780|P3|Participant Flow|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555273|NCT00624780|P2|Participant Flow|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555274|NCT00624780|P1|Participant Flow|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555275|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555276|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555277|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555278|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555279|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555280|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555281|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555282|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555283|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555284|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555683|NCT00624065|E1|Reported Event|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
555285|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555286|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555287|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555288|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555289|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555290|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555291|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555292|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555293|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555684|NCT00624052|B5|Baseline|Total|Total of all reporting groups
555294|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555295|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555296|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555297|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555298|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555299|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555300|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555301|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555302|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555685|NCT00624052|B4|Baseline|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555303|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555304|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555305|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555306|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555307|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555308|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555309|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555310|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555311|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555686|NCT00624052|B3|Baseline|Titrated Telmisartan 80mg and Amlodipine 10mg|
555312|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555313|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555314|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555315|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555316|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555317|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555318|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555319|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555320|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555687|NCT00624052|B2|Baseline|Randomised Telmisartan 80mg and Amlodipine 10mg|
555321|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555322|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555323|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555324|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555325|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555326|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555327|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555328|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555329|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555688|NCT00624052|B1|Baseline|Telmisartan 40mg and Amlodipine 10mg|
555330|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555331|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555332|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555333|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555334|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555335|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555336|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555337|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555338|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555475|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
555476|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
555340|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555341|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555342|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555343|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555344|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555345|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555346|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555347|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555348|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555477|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
555349|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555350|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555351|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555352|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555353|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555354|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555355|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555356|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555357|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555478|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
555479|NCT00624559|E4|Reported Event|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
555480|NCT00624559|E3|Reported Event|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
555358|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555359|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555360|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555361|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555362|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555363|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555364|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555365|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555366|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555367|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555368|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555369|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555370|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555371|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555372|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555373|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555374|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555375|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555376|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555377|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555378|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555379|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555380|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555381|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555382|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555383|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555384|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555385|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555386|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555481|NCT00624559|E2|Reported Event|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
555512|NCT00624468|B2|Baseline|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555387|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555388|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555389|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555390|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555391|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555392|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555393|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555394|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555395|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
556308|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
555396|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555397|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555398|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555399|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555400|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555401|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555402|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555403|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555404|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555413|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555510|NCT00624520|E1|Reported Event|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555405|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555406|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555407|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555408|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555409|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555410|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555411|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555412|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555414|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555415|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555416|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555417|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555418|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555419|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555420|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555421|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555422|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555423|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555424|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555443|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555425|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555426|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555427|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555428|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555429|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555430|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555431|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555432|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555468|NCT00624559|P3|Participant Flow|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
555433|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555434|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555435|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555436|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555437|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555438|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555439|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555440|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555441|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555442|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555469|NCT00624559|P2|Participant Flow|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
555444|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555445|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555446|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
555447|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555448|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
555449|NCT00624780|E6|Reported Event|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555450|NCT00624780|E5|Reported Event|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555451|NCT00624780|E4|Reported Event|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555452|NCT00624780|E3|Reported Event|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555470|NCT00624559|P1|Participant Flow|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
555471|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
555472|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
555473|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
555453|NCT00624780|E2|Reported Event|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
555454|NCT00624780|E1|Reported Event|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
555455|NCT00624585|B1|Baseline|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
555456|NCT00624585|P1|Participant Flow|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
555457|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
555458|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
555459|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
555460|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
555461|NCT00624585|E1|Reported Event|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
555462|NCT00624559|B5|Baseline|Total|Total of all reporting groups
555463|NCT00624559|B4|Baseline|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
555464|NCT00624559|B3|Baseline|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
555465|NCT00624559|B2|Baseline|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
555466|NCT00624559|B1|Baseline|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
555467|NCT00624559|P4|Participant Flow|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
555511|NCT00624468|B3|Baseline|Total|Total of all reporting groups
555482|NCT00624559|E1|Reported Event|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
555483|NCT00624520|B3|Baseline|Total|Total of all reporting groups
555484|NCT00624520|B2|Baseline|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555485|NCT00624520|B1|Baseline|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555486|NCT00624520|P2|Participant Flow|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555487|NCT00624520|P1|Participant Flow|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555488|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555489|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555490|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555491|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555492|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555493|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555494|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555495|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555496|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555497|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555498|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555499|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555500|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555501|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555502|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555503|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555504|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555505|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555506|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555507|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555508|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
555509|NCT00624520|E2|Reported Event|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
555513|NCT00624468|B1|Baseline|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555514|NCT00624468|P4|Participant Flow|Atacicept: SFU Period|Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
555515|NCT00624468|P3|Participant Flow|Placebo: SFU Period|Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.
555516|NCT00624468|P2|Participant Flow|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555517|NCT00624468|P1|Participant Flow|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555518|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555519|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555520|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555521|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555522|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555523|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555524|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555525|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555526|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555527|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555528|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555529|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555530|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555531|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555532|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555533|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555534|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555535|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555536|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555537|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555538|NCT00624468|E4|Reported Event|Atacicept: SFU Period|Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
555539|NCT00624468|E3|Reported Event|Placebo: SFU Period|Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
555540|NCT00624468|E2|Reported Event|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
555541|NCT00624468|E1|Reported Event|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
555542|NCT00624442|B6|Baseline|Total|Total of all reporting groups
555543|NCT00624442|B5|Baseline|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
555544|NCT00624442|B4|Baseline|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
556309|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
555545|NCT00624442|B3|Baseline|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
555546|NCT00624442|B2|Baseline|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
555547|NCT00624442|B1|Baseline|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
555548|NCT00624442|P5|Participant Flow|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
555549|NCT00624442|P4|Participant Flow|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
555550|NCT00624442|P3|Participant Flow|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
555551|NCT00624442|P2|Participant Flow|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
555552|NCT00624442|P1|Participant Flow|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
555553|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555554|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555555|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555556|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555557|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555558|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555559|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555560|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555561|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555562|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555563|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555564|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
555565|NCT00624442|E12|Reported Event|Cohort 5, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
555566|NCT00624442|E11|Reported Event|Cohort 5, Loading Dose of 0.75 mg/kg/hr|Loading dose is first hour of IV infusion.
555567|NCT00624442|E10|Reported Event|Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
555568|NCT00624442|E9|Reported Event|Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr|Loading dose is first hour of IV infusion.
555569|NCT00624442|E8|Reported Event|Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr|Loading dose is first hour of IV infusion.
555570|NCT00624442|E7|Reported Event|Cohort 2, Loading Dose of 2.2 mg/kg/hr|Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose.
555571|NCT00624442|E6|Reported Event|Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
555572|NCT00624442|E5|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr|Loading dose is the first hour of IV infusion.
555573|NCT00624442|E4|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr|Loading dose is the first hour of IV infusion.
555574|NCT00624442|E3|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr|Loading dose is the first hour of IV infusion.
555575|NCT00624442|E2|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr|Loading dose is the first hour of IV infusion.
555576|NCT00624442|E1|Reported Event|Placebo|
555577|NCT00624416|B1|Baseline|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
555578|NCT00624416|P1|Participant Flow|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
555674|NCT00624065|B2|Baseline|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
555579|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
555580|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
555581|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
555582|NCT00624416|E1|Reported Event|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
555583|NCT00624377|B1|Baseline|Spiriva 18µg With HandiHaler Device on COPD Patients|
555584|NCT00624377|P1|Participant Flow|Spiriva 18µg With HandiHaler Device on COPD Patients|
555585|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555586|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555587|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555588|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555589|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555590|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555591|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555592|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
555593|NCT00624377|E1|Reported Event|Spiriva 18µg With HandiHaler Device on COPD Patients|
555594|NCT00624338|B4|Baseline|Total|Total of all reporting groups
555595|NCT00624338|B3|Baseline|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555596|NCT00624338|B2|Baseline|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555597|NCT00624338|B1|Baseline|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555598|NCT00624338|P3|Participant Flow|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555599|NCT00624338|P2|Participant Flow|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555600|NCT00624338|P1|Participant Flow|Atacicept 75 mg|75 milligram (mg) atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555601|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555602|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555603|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555604|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555605|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555606|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555607|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555608|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555609|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555610|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555611|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555612|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555613|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555614|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555675|NCT00624065|B1|Baseline|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
555615|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555616|NCT00624338|E3|Reported Event|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555617|NCT00624338|E2|Reported Event|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555618|NCT00624338|E1|Reported Event|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
555619|NCT00624286|B3|Baseline|Total|Total of all reporting groups
555620|NCT00624286|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555621|NCT00624286|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555622|NCT00624286|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555623|NCT00624286|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555624|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555625|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555626|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555627|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555628|NCT00624286|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555629|NCT00624286|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
555630|NCT00624234|B7|Baseline|Total|Total of all reporting groups
555631|NCT00624234|B6|Baseline|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
555632|NCT00624234|B5|Baseline|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
555633|NCT00624234|B4|Baseline|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
555634|NCT00624234|B3|Baseline|Typically Developing Readers|Control group--children who do not have reading problems
555676|NCT00624065|P2|Participant Flow|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
555677|NCT00624065|P1|Participant Flow|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
555678|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
555679|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
555635|NCT00624234|B2|Baseline|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
555636|NCT00624234|B1|Baseline|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
555637|NCT00624234|P6|Participant Flow|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
555638|NCT00624234|P5|Participant Flow|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
555639|NCT00624234|P4|Participant Flow|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
555640|NCT00624234|P3|Participant Flow|Typically Developing Readers|Control group--children who do not have reading problems
555641|NCT00624234|P2|Participant Flow|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
555642|NCT00624234|P1|Participant Flow|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
555643|NCT00624234|O6|Outcome|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
555644|NCT00624234|O5|Outcome|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
555645|NCT00624234|O4|Outcome|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
555646|NCT00624234|O3|Outcome|Typically Developing Readers|Control group--children who do not have reading problems
555647|NCT00624234|O2|Outcome|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
555648|NCT00624234|O1|Outcome|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
555649|NCT00624234|E6|Reported Event|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
555680|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
555650|NCT00624234|E5|Reported Event|IRD-Tutoring Program 2|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.
555651|NCT00624234|E4|Reported Event|IRD-Tutoring Program 1|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.
555652|NCT00624234|E3|Reported Event|Typically Developing Readers|Control group--children who do not have reading problems
555653|NCT00624234|E2|Reported Event|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
555654|NCT00624234|E1|Reported Event|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
555655|NCT00624221|B3|Baseline|Total|Total of all reporting groups
555656|NCT00624221|B2|Baseline|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
555657|NCT00624221|B1|Baseline|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
555658|NCT00624221|P2|Participant Flow|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
555659|NCT00624221|P1|Participant Flow|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
555660|NCT00624221|O2|Outcome|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
555661|NCT00624221|O1|Outcome|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
555662|NCT00624221|E2|Reported Event|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
555663|NCT00624221|E1|Reported Event|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
555664|NCT00624195|B3|Baseline|Total|Total of all reporting groups
555665|NCT00624195|B2|Baseline|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
555666|NCT00624195|B1|Baseline|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
555667|NCT00624195|P2|Participant Flow|Non-CNS-targeted|"Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
555668|NCT00624195|P1|Participant Flow|CNS-targeted|"CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, under dosing).~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
555669|NCT00624195|O2|Outcome|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
555670|NCT00624195|O1|Outcome|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
555671|NCT00624195|E2|Reported Event|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
555672|NCT00624195|E1|Reported Event|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
555673|NCT00624065|B3|Baseline|Total|Total of all reporting groups
555689|NCT00624052|P4|Participant Flow|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
555690|NCT00624052|P3|Participant Flow|Titrated Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
555691|NCT00624052|P2|Participant Flow|Randomised Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
555692|NCT00624052|P1|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
555693|NCT00624052|O3|Outcome|Pre-titration: Total|
555694|NCT00624052|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
555695|NCT00624052|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
555696|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555697|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555698|NCT00624052|O3|Outcome|Pre-antihypertensive: Total|
555699|NCT00624052|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
555700|NCT00624052|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
555701|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555702|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555703|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555704|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555705|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555706|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555707|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555708|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555709|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555710|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555711|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555712|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555713|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555714|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555715|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555716|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555717|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555718|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555719|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555720|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555721|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555722|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555723|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555724|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555725|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555726|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555727|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555728|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555729|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555730|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555731|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555732|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555733|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555734|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
555735|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
555736|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
555737|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
555738|NCT00624052|E2|Reported Event|Telmisartan 80mg and Amlodipine 10mg|The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group
555739|NCT00624052|E1|Reported Event|Telmisartan 40mg and Amlodipine 10mg|The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants
555740|NCT00624013|B3|Baseline|Total|Total of all reporting groups
555741|NCT00624013|B2|Baseline|Active Comparator: Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
555742|NCT00624013|B1|Baseline|Placebo Comparator: Placebo|Placebo: 50 mg up to 100 mg daily for 6 months
555743|NCT00624013|P2|Participant Flow|Active Comparator: Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
555744|NCT00624013|P1|Participant Flow|Placebo Comparator:Placebo|Placebo: 50 mg up to 100 mg daily for 6 months
555745|NCT00624013|O2|Outcome|Sertraline (Zoloft)|Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months
555746|NCT00624013|O1|Outcome|Placebo|Placebo 50 mg up to 100 mg daily for 6 months
555747|NCT00624013|O2|Outcome|Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
555748|NCT00624013|O1|Outcome|Placebo|Placebo Comparator: 50 mg up to 100 mg daily for 6 months
555749|NCT00624013|E2|Reported Event|Sertraline|sertraline: 50 mg up to 100 mg daily for 6 months
555750|NCT00624013|E1|Reported Event|Placebo|Placebo Comparator: 50 mg up to 100 mg daily for 6 months
555751|NCT00623974|B5|Baseline|Total|Total of all reporting groups
555752|NCT00623974|B4|Baseline|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555753|NCT00623974|B3|Baseline|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555754|NCT00623974|B2|Baseline|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555755|NCT00623974|B1|Baseline|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555756|NCT00623974|P4|Participant Flow|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555757|NCT00623974|P3|Participant Flow|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555758|NCT00623974|P2|Participant Flow|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555759|NCT00623974|P1|Participant Flow|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555760|NCT00623974|O4|Outcome|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555761|NCT00623974|O3|Outcome|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555762|NCT00623974|O2|Outcome|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555763|NCT00623974|O1|Outcome|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555764|NCT00623974|E4|Reported Event|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555765|NCT00623974|E3|Reported Event|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555766|NCT00623974|E2|Reported Event|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555767|NCT00623974|E1|Reported Event|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
555768|NCT00623935|B1|Baseline|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
555769|NCT00623935|P1|Participant Flow|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
555770|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
555771|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
555772|NCT00623935|E1|Reported Event|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
555773|NCT00623831|B3|Baseline|Total|Total of all reporting groups
555774|NCT00623831|B2|Baseline|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
555775|NCT00623831|B1|Baseline|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
555776|NCT00623831|P2|Participant Flow|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
555777|NCT00623831|P1|Participant Flow|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a dose-limiting toxicity (DLT) until the desired pyrogenic effect was observed.
555778|NCT00623831|O2|Outcome|Cohort 2 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
555779|NCT00623831|O1|Outcome|Cohort 1 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
555780|NCT00623831|O1|Outcome|Cohort 1 (Immune Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
555781|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
556310|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
555782|NCT00623831|O2|Outcome|Cohort 2 (Safety Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
555783|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
555784|NCT00623831|E2|Reported Event|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
555785|NCT00623831|E1|Reported Event|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
555786|NCT00623805|B3|Baseline|Total|Total of all reporting groups
555787|NCT00623805|B2|Baseline|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555788|NCT00623805|B1|Baseline|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555789|NCT00623805|P2|Participant Flow|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555790|NCT00623805|P1|Participant Flow|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555791|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555792|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555793|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555794|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555795|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555796|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555797|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555798|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555799|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555800|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555890|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555801|NCT00623805|E2|Reported Event|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555802|NCT00623805|E1|Reported Event|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
555803|NCT00623779|B4|Baseline|Total|Total of all reporting groups
555804|NCT00623779|B3|Baseline|Standard Therapy|Standard Therapy
555805|NCT00623779|B2|Baseline|AZD0837 300 mg|AZD0837 300 mg
555806|NCT00623779|B1|Baseline|AZD0837 150 mg|AZD0837 150 mg
555807|NCT00623779|P3|Participant Flow|Standard Therapy|Standard Therapy
555808|NCT00623779|P2|Participant Flow|AZD0837 300 mg|AZD0837 300 mg
555809|NCT00623779|P1|Participant Flow|AZD0837 150 mg|AZD0837 150 mg
555810|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555811|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555812|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555813|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555814|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555815|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555816|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555817|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555818|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555819|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555820|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555821|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555822|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555823|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555824|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555825|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555826|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555827|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555828|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555829|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555830|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555831|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555832|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555833|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555834|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555835|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555836|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555837|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555838|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555839|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555840|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555841|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555842|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555843|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555844|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555845|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555846|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555847|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555848|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555849|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
555850|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
555851|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
555852|NCT00623779|E3|Reported Event|Standard Therapy|Standard Therapy
555853|NCT00623779|E2|Reported Event|AZD0837 300 mg|AZD0837 300 mg
555854|NCT00623779|E1|Reported Event|AZD0837 150 mg|AZD0837 150 mg
555855|NCT00623766|B3|Baseline|Total|Total of all reporting groups
555856|NCT00623766|B2|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555857|NCT00623766|B1|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555858|NCT00623766|P2|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555891|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
556311|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
555859|NCT00623766|P1|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555860|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555861|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients|"Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.~Ipilimumab: 10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance"
555862|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555863|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555864|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555865|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555866|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555867|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555868|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555869|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555870|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555871|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
556437|NCT00622401|B4|Baseline|Total|Total of all reporting groups
555872|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555873|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555874|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555875|NCT00623766|O1|Outcome|Ipilimumab 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555876|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555877|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555878|NCT00623766|E2|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555879|NCT00623766|E1|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
555880|NCT00623727|B3|Baseline|Total|Total of all reporting groups
555881|NCT00623727|B2|Baseline|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555882|NCT00623727|B1|Baseline|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555883|NCT00623727|P2|Participant Flow|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555884|NCT00623727|P1|Participant Flow|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555885|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555886|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555887|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555888|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555889|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555892|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555893|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555894|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555895|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555896|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555897|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555898|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
555899|NCT00623727|E4|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Extension|Reporting group 4 (RG4): Open Label Extension, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
555900|NCT00623727|E3|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Follow-up|Reporting group 3 (RG3): Open Label Follow-up, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555901|NCT00623727|E2|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Double Blind|Reporting group 2 (RG2): Double Blind Study, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
555902|NCT00623727|E1|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Double Blind|Reporting Group 1 (RG1): Double Blind Study, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
555903|NCT00623714|B1|Baseline|All Patients|All Randomized Patients
555904|NCT00623714|P2|Participant Flow|Fluticasone Then Placebo|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose, Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
555905|NCT00623714|P1|Participant Flow|Placebo Then Fluticasone|Days 1-2 Placebo twice a Day (b.i.d.) + Day 3 Placebo single dose, Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
555906|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
555907|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
555908|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
555909|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
555910|NCT00623714|E2|Reported Event|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
555911|NCT00623714|E1|Reported Event|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
555912|NCT00623636|B3|Baseline|Total|Total of all reporting groups
555913|NCT00623636|B2|Baseline|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555914|NCT00623636|B1|Baseline|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555915|NCT00623636|P2|Participant Flow|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555916|NCT00623636|P1|Participant Flow|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555917|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555918|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555919|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555920|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555921|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555922|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555923|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555924|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555925|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555926|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555927|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555928|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555929|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555930|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555931|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555932|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555933|NCT00623636|E3|Reported Event|Open-label MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555934|NCT00623636|E2|Reported Event|Double-blind MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
555935|NCT00623636|E1|Reported Event|Double-blind Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
555936|NCT00623597|B3|Baseline|Total|Total of all reporting groups
555937|NCT00623597|B2|Baseline|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555938|NCT00623597|B1|Baseline|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555939|NCT00623597|P2|Participant Flow|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555940|NCT00623597|P1|Participant Flow|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555941|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555942|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555943|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
556024|NCT00623480|P1|Participant Flow|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
555944|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555945|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555946|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555947|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555948|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555949|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555950|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555951|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555952|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555953|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555954|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555955|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555956|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555957|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555958|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555959|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555960|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555961|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555962|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555963|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555964|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555965|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555966|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555967|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555968|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555969|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555970|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555971|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555972|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555973|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555974|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555975|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555976|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555977|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555978|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555979|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555980|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555981|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555982|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555983|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555984|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555985|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555986|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555987|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555988|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555989|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555990|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555991|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555992|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555993|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555994|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555995|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555996|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555997|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
556025|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
556026|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
555998|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
555999|NCT00623597|E3|Reported Event|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
556000|NCT00623597|E2|Reported Event|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
556001|NCT00623597|E1|Reported Event|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
556002|NCT00623545|B1|Baseline|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcomes are performed before and at the end of treatment. Outcomes are based on the change in the variables.
556003|NCT00623545|P1|Participant Flow|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcome variables are made before treatment and again at the end of the1 treatment period made. Outcomes are based on the change in these variables.
556004|NCT00623545|O1|Outcome|Exenitide Treatment|
556005|NCT00623545|O1|Outcome|Exenitide Treatment|There is one treatment arm. Subjects serve as their own controls for the outcome measure. The measures are made before the treatment is started at during the end of the treatment.
556006|NCT00623545|E1|Reported Event|Single Arm Study of Exenatide Treatment|
556007|NCT00623506|B3|Baseline|Total|Total of all reporting groups
556008|NCT00623506|B2|Baseline|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
556009|NCT00623506|B1|Baseline|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
556010|NCT00623506|P2|Participant Flow|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
556011|NCT00623506|P1|Participant Flow|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
556012|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
556013|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
556014|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
556015|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
556016|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
556017|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
556018|NCT00623506|E2|Reported Event|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
556019|NCT00623506|E1|Reported Event|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
556020|NCT00623480|B3|Baseline|Total|Total of all reporting groups
556021|NCT00623480|B2|Baseline|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
556022|NCT00623480|B1|Baseline|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
556023|NCT00623480|P2|Participant Flow|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
556027|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
556028|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
556029|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
556030|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
556031|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
556032|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
556033|NCT00623480|E2|Reported Event|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
556034|NCT00623480|E1|Reported Event|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
556035|NCT00623467|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556036|NCT00623467|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556037|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556038|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556039|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556040|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556041|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556042|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556043|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556044|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556045|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556046|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556047|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556048|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556049|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556050|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556051|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556052|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556053|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556055|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556056|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556057|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556058|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556059|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556060|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556061|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556062|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556063|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556064|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556065|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556066|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556067|NCT00623467|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556068|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556069|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556070|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556071|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556072|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556073|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556074|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556075|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556076|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556077|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556078|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556079|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556080|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556081|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556082|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556084|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556085|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556086|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556087|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556088|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556089|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556090|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556091|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556092|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556093|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556094|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556095|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556096|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556097|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
556098|NCT00623467|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
556099|NCT00623441|B1|Baseline|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
556100|NCT00623441|P1|Participant Flow|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
556101|NCT00623441|O1|Outcome|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
556102|NCT00623441|E1|Reported Event|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
556103|NCT00623428|B3|Baseline|Total|Total of all reporting groups
556104|NCT00623428|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556105|NCT00623428|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556106|NCT00623428|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556107|NCT00623428|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556143|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556108|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556109|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556110|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556111|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556112|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556113|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556114|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556115|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556116|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556117|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556118|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556119|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556144|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556145|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556120|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556121|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556122|NCT00623428|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
556123|NCT00623428|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
556124|NCT00623233|B1|Baseline|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
556125|NCT00623233|P1|Participant Flow|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
556126|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
556127|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
556128|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
556129|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
556130|NCT00623233|E1|Reported Event|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
556131|NCT00623194|B1|Baseline|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556132|NCT00623194|P1|Participant Flow|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556133|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556134|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556135|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556136|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556137|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556138|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556139|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556140|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556141|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556142|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556146|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556147|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556148|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556149|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556150|NCT00623194|E1|Reported Event|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
556151|NCT00623181|B3|Baseline|Total|Total of all reporting groups
556152|NCT00623181|B2|Baseline|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
556153|NCT00623181|B1|Baseline|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
556154|NCT00623181|P2|Participant Flow|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
556155|NCT00623181|P1|Participant Flow|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
556156|NCT00623181|O2|Outcome|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
556157|NCT00623181|O1|Outcome|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
556158|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0.
556159|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
556160|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
556161|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0.
556162|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
556163|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
556164|NCT00623181|E2|Reported Event|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
556165|NCT00623181|E1|Reported Event|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
556166|NCT00623103|B3|Baseline|Total|Total of all reporting groups
556167|NCT00623103|B2|Baseline|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556168|NCT00623103|B1|Baseline|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556169|NCT00623103|P2|Participant Flow|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556170|NCT00623103|P1|Participant Flow|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556171|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556172|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556173|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556174|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556292|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556175|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556176|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556177|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556178|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556179|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556180|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556181|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556182|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556183|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556184|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556185|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
556186|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
556187|NCT00623103|E2|Reported Event|Exelon Patch|Exelon Patch
556188|NCT00623103|E1|Reported Event|Exelon Capsule|Exelon Capsule
556189|NCT00623012|B1|Baseline|Rapamycin Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
556190|NCT00623012|P1|Participant Flow|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
556191|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
556293|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556294|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556295|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556192|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
556193|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
556194|NCT00623012|E1|Reported Event|Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
556195|NCT00622908|B3|Baseline|Total|Total of all reporting groups
556196|NCT00622908|B2|Baseline|Vehicle|Vehicle of ISV-403
556197|NCT00622908|B1|Baseline|ISV-403|0.6% ISV-403
556198|NCT00622908|P2|Participant Flow|Vehicle|Vehicle of ISV-403
556199|NCT00622908|P1|Participant Flow|ISV-403|0.6% ISV-403
556200|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
556201|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
556202|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
556203|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
556204|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
556205|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
556206|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
556207|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
556208|NCT00622908|E2|Reported Event|Vehicle|Vehicle of ISV-403
556209|NCT00622908|E1|Reported Event|ISV-403|0.6% ISV-403
556210|NCT00622869|B4|Baseline|Total|Total of all reporting groups
556211|NCT00622869|B3|Baseline|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
556212|NCT00622869|B2|Baseline|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
556213|NCT00622869|B1|Baseline|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
556214|NCT00622869|P3|Participant Flow|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
556215|NCT00622869|P2|Participant Flow|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
556216|NCT00622869|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
556217|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
556218|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
556219|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
556220|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
556221|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
556222|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
556223|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
556224|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
556225|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
556226|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
556227|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
556228|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
556229|NCT00622869|E3|Reported Event|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids
556230|NCT00622869|E2|Reported Event|Tacrolimus Elimination|Low dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids
556231|NCT00622869|E1|Reported Event|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids
556232|NCT00622739|B3|Baseline|Total|Total of all reporting groups
556296|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556297|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556298|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556233|NCT00622739|B2|Baseline|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556234|NCT00622739|B1|Baseline|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556235|NCT00622739|P2|Participant Flow|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556236|NCT00622739|P1|Participant Flow|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556237|NCT00622739|O2|Outcome|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556238|NCT00622739|O1|Outcome|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556239|NCT00622739|E2|Reported Event|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556240|NCT00622739|E1|Reported Event|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
556241|NCT00622726|B3|Baseline|Total|Total of all reporting groups
556242|NCT00622726|B2|Baseline|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
556243|NCT00622726|B1|Baseline|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
556244|NCT00622726|P2|Participant Flow|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
556245|NCT00622726|P1|Participant Flow|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
556246|NCT00622726|O4|Outcome|Conventional Laser-Control Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Posterior Zone II.
556247|NCT00622726|O3|Outcome|Bevacizumab Experimental Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Posterior Zone II.
556248|NCT00622726|O2|Outcome|Conventional Laser-Control Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Zone I.
556249|NCT00622726|O1|Outcome|Bevacizumab-Experimental Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Zone I.
556250|NCT00622726|O2|Outcome|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients/66 eyes had zone I ROP; 40 patients/80 eyes had posterior zone II ROP.
556251|NCT00622726|O1|Outcome|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients/62 eyes had zone I ROP; 39 patients/78 eyes had zone II posterior ROP.
556252|NCT00622726|E2|Reported Event|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
556253|NCT00622726|E1|Reported Event|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
556254|NCT00622713|B1|Baseline|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556255|NCT00622713|P1|Participant Flow|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556299|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556256|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556257|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556258|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556259|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556260|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556261|NCT00622713|E1|Reported Event|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
556262|NCT00622700|B4|Baseline|Total|Total of all reporting groups
556263|NCT00622700|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556264|NCT00622700|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556265|NCT00622700|B1|Baseline|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556266|NCT00622700|P7|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556267|NCT00622700|P6|Participant Flow|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556268|NCT00622700|P5|Participant Flow|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556269|NCT00622700|P4|Participant Flow|Placebo/ Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556270|NCT00622700|P3|Participant Flow|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
556271|NCT00622700|P2|Participant Flow|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
556272|NCT00622700|P1|Participant Flow|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
556273|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556274|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556275|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556276|NCT00622700|O4|Outcome|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556277|NCT00622700|O3|Outcome|Placebo/ Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556278|NCT00622700|O2|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556279|NCT00622700|O1|Outcome|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556280|NCT00622700|O4|Outcome|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556281|NCT00622700|O3|Outcome|Placebo/ Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556282|NCT00622700|O2|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556283|NCT00622700|O1|Outcome|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556284|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556285|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556286|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556287|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556288|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556289|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556290|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556291|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556312|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556313|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556314|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556315|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556316|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556317|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556318|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556319|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556320|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
556321|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
556322|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
556323|NCT00622700|E7|Reported Event|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556324|NCT00622700|E6|Reported Event|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
556325|NCT00622700|E5|Reported Event|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556326|NCT00622700|E4|Reported Event|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
556327|NCT00622700|E3|Reported Event|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
556328|NCT00622700|E2|Reported Event|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
556329|NCT00622700|E1|Reported Event|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
556330|NCT00622635|B1|Baseline|Entire Study Population|The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556331|NCT00622635|P6|Participant Flow|Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556332|NCT00622635|P5|Participant Flow|Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556333|NCT00622635|P4|Participant Flow|Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556334|NCT00622635|P3|Participant Flow|Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556335|NCT00622635|P2|Participant Flow|Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556481|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556336|NCT00622635|P1|Participant Flow|Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556337|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556338|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556339|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556340|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556341|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556342|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556343|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556344|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556345|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556346|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556347|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556348|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556349|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556350|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556351|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556352|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556353|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556354|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556482|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556355|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556356|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556357|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556358|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556359|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556360|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556361|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556362|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556363|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556364|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556365|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556366|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556367|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556368|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556369|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556370|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556371|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556372|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556373|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556374|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556483|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556484|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556375|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556376|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556377|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556378|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556379|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556380|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556381|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556382|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556383|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556384|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556385|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556386|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556387|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556388|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556389|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556390|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556391|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556392|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556393|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556394|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556438|NCT00622401|B3|Baseline|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
556395|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556396|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556397|NCT00622635|E3|Reported Event|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556398|NCT00622635|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556399|NCT00622635|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
556400|NCT00622518|B3|Baseline|Total|Total of all reporting groups
556401|NCT00622518|B2|Baseline|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
556402|NCT00622518|B1|Baseline|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
556403|NCT00622518|P2|Participant Flow|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
556404|NCT00622518|P1|Participant Flow|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
556405|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
556406|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
556407|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
556408|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
556409|NCT00622518|E2|Reported Event|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
556410|NCT00622518|E1|Reported Event|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
556411|NCT00622440|B3|Baseline|Total|Total of all reporting groups
556412|NCT00622440|B2|Baseline|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
556413|NCT00622440|B1|Baseline|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
556414|NCT00622440|P2|Participant Flow|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
556415|NCT00622440|P1|Participant Flow|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
556416|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
556417|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
556418|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
556419|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
556420|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
556421|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
556422|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
556423|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
556424|NCT00622440|E2|Reported Event|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
556425|NCT00622440|E1|Reported Event|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
556426|NCT00622427|B3|Baseline|Total|Total of all reporting groups
556427|NCT00622427|B2|Baseline|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
556428|NCT00622427|B1|Baseline|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
556429|NCT00622427|P2|Participant Flow|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
556430|NCT00622427|P1|Participant Flow|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
556431|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep
556432|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep
556433|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep first
556434|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep first
556435|NCT00622427|E2|Reported Event|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
556436|NCT00622427|E1|Reported Event|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
556439|NCT00622401|B2|Baseline|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
556440|NCT00622401|B1|Baseline|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
556441|NCT00622401|P3|Participant Flow|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
556442|NCT00622401|P2|Participant Flow|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
556443|NCT00622401|P1|Participant Flow|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
556444|NCT00622401|O3|Outcome|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
556445|NCT00622401|O2|Outcome|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
556446|NCT00622401|O1|Outcome|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
556447|NCT00622401|O1|Outcome|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
556448|NCT00622401|E1|Reported Event|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
556449|NCT00622388|B1|Baseline|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556450|NCT00622388|P1|Participant Flow|Ofatumumab|Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg
556451|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556452|NCT00622388|O1|Outcome|Overall Study Arm|
556453|NCT00622388|O1|Outcome|Overall Study Arm|
556454|NCT00622388|O1|Outcome|Overall Study Arm|
556455|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556456|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556457|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556458|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556459|NCT00622388|O1|Outcome|Overall Study Arm|
556460|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556461|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556462|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556463|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556464|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556465|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556466|NCT00622388|E1|Reported Event|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
556467|NCT00622336|B1|Baseline|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
556468|NCT00622336|P1|Participant Flow|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
556469|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
556470|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
556471|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
556472|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
556473|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
556474|NCT00622336|E2|Reported Event|Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
556475|NCT00622336|E1|Reported Event|Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
556476|NCT00622284|B3|Baseline|Total|Total of all reporting groups
556477|NCT00622284|B2|Baseline|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556478|NCT00622284|B1|Baseline|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556479|NCT00622284|P2|Participant Flow|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556480|NCT00622284|P1|Participant Flow|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556485|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556486|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556487|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556488|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556489|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556490|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556491|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556492|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556493|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556494|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556495|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556496|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556497|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556498|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556499|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556500|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556501|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556502|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556503|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556504|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556505|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556506|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556507|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556508|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556509|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556510|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556511|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556512|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556513|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556514|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556515|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556516|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556517|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556518|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556519|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556520|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556521|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556522|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556523|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556524|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556525|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556526|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556527|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556528|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556529|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556530|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556531|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556532|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556533|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556534|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556535|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556536|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556537|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556538|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556539|NCT00622284|E2|Reported Event|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
556540|NCT00622284|E1|Reported Event|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
556541|NCT00622167|B1|Baseline|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
556542|NCT00622167|P1|Participant Flow|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
556543|NCT00622167|O1|Outcome|Plaque Characteristics|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology.
556544|NCT00622167|E1|Reported Event|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
556545|NCT00621985|B1|Baseline|Experimental Group|These subjects were admitted twice, once while on baseline hydrocortisone and once on dexamethasone.
556546|NCT00621985|P1|Participant Flow|Experimental|Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.
556547|NCT00621985|O2|Outcome|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
556548|NCT00621985|O1|Outcome|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
556549|NCT00621985|E2|Reported Event|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
556550|NCT00621985|E1|Reported Event|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
556551|NCT00621959|B3|Baseline|Total|Total of all reporting groups
556552|NCT00621959|B2|Baseline|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
556553|NCT00621959|B1|Baseline|Placebo|Matched placebo tablets once daily
556554|NCT00621959|P2|Participant Flow|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
556555|NCT00621959|P1|Participant Flow|Placebo|Matched placebo tablets once daily
556556|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
556557|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
556558|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
556559|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
556560|NCT00621959|E2|Reported Event|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
556561|NCT00621959|E1|Reported Event|Placebo|Matched placebo tablets once daily
556562|NCT00621946|B3|Baseline|Total|Total of all reporting groups
556563|NCT00621946|B2|Baseline|Placebo|Placebo Matching Escitalopram taken orally daily.
556564|NCT00621946|B1|Baseline|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556565|NCT00621946|P2|Participant Flow|Matching Placebo|Placebo Matching Escitalopram taken orally daily (for a 12-week duration).
556566|NCT00621946|P1|Participant Flow|Escitalopram|Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
556567|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
556568|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556569|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
556570|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556571|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
556572|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556573|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
556574|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556575|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
556576|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556577|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
556578|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556579|NCT00621946|E2|Reported Event|Placebo|Placebo Matching Escitalopram taken orally daily.
556580|NCT00621946|E1|Reported Event|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
556581|NCT00621933|B1|Baseline|All Patients|All patients receiving cataract surgery
556582|NCT00621933|P1|Participant Flow|All Patients|All patients receiving cataract surgery
556583|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
556584|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
556585|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
556586|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
556587|NCT00621933|E1|Reported Event|All Patients|All patients receiving cataract surgery
556588|NCT00621855|B6|Baseline|Total|Total of all reporting groups
556589|NCT00621855|B5|Baseline|Placebo|26 week blinded treatment
556590|NCT00621855|B4|Baseline|150mg Dabigatran Etexilate|26 week blinded treatment
556591|NCT00621855|B3|Baseline|110mg Dabigatran Etexilate|26 week blinded treatment
556592|NCT00621855|B2|Baseline|75mg Dabigatran Etexilate|26 week blinded treatment
556593|NCT00621855|B1|Baseline|50mg Dabigatran Etexilate|26 week blinded treatment
556594|NCT00621855|P5|Participant Flow|Placebo|26 week blinded treatment
556595|NCT00621855|P4|Participant Flow|150mg Dabigatran Etexilate|26 week blinded treatment
556596|NCT00621855|P3|Participant Flow|110mg Dabigatran Etexilate|26 week blinded treatment
556597|NCT00621855|P2|Participant Flow|75mg Dabigatran Etexilate|26 week blinded treatment
556598|NCT00621855|P1|Participant Flow|50mg Dabigatran Etexilate|26 week blinded treatment
556599|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
556600|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
556601|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
556602|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
556603|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
556604|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
556605|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
556606|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
556607|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
556608|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
556609|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
556610|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
556611|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
556612|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
556613|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
556614|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
556615|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
556616|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
556617|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
556618|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
556619|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
556620|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
556621|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
556622|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
556623|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
556624|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
556625|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
556626|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
556627|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
556628|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
556629|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
556630|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
556631|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
556632|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
556633|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
556634|NCT00621855|E5|Reported Event|Placebo|26 week blinded treatment
556635|NCT00621855|E4|Reported Event|150mg Dabigatran Etexilate|26 week blinded treatment
556636|NCT00621855|E3|Reported Event|110mg Dabigatran Etexilate|26 week blinded treatment
556637|NCT00621855|E2|Reported Event|75mg Dabigatran Etexilate|26 week blinded treatment
556638|NCT00621855|E1|Reported Event|50mg Dabigatran Etexilate|26 week blinded treatment
556639|NCT00621842|B1|Baseline|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556640|NCT00621842|P1|Participant Flow|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556641|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556642|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556643|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556644|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556645|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556646|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556647|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556648|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556649|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556650|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556651|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556652|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556653|NCT00621842|E1|Reported Event|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
556654|NCT00621777|B3|Baseline|Total|Total of all reporting groups
556655|NCT00621777|B2|Baseline|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
556656|NCT00621777|B1|Baseline|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
556699|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556741|NCT00621543|E1|Reported Event|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
556657|NCT00621777|P2|Participant Flow|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
556658|NCT00621777|P1|Participant Flow|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.~Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:~Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
556659|NCT00621777|O2|Outcome|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
556660|NCT00621777|O1|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.~Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:~Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
556661|NCT00621777|O2|Outcome|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
556662|NCT00621777|O1|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.~Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:~Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
556663|NCT00621777|O2|Outcome|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
556664|NCT00621777|O1|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
556665|NCT00621777|E3|Reported Event|Placebo|2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52
556666|NCT00621777|E2|Reported Event|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
556700|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556701|NCT00621764|E4|Reported Event|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
556742|NCT00621530|B3|Baseline|Total|Total of all reporting groups
556667|NCT00621777|E1|Reported Event|Varenicline Open Label (Open Phase)|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~1. Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks."
556668|NCT00621764|B5|Baseline|Total|Total of all reporting groups
556669|NCT00621764|B4|Baseline|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
556670|NCT00621764|B3|Baseline|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556671|NCT00621764|B2|Baseline|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
556672|NCT00621764|B1|Baseline|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556673|NCT00621764|P4|Participant Flow|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556674|NCT00621764|P3|Participant Flow|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556675|NCT00621764|P2|Participant Flow|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556676|NCT00621764|P1|Participant Flow|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556677|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556678|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556679|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556680|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556681|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556682|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556683|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556684|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556685|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556686|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556687|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556688|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556689|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart.
556690|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556691|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556692|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556693|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556694|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556695|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556696|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556697|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
556698|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556702|NCT00621764|E3|Reported Event|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556703|NCT00621764|E2|Reported Event|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
556704|NCT00621764|E1|Reported Event|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
556705|NCT00621686|B3|Baseline|Total|Total of all reporting groups
556706|NCT00621686|B2|Baseline|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556707|NCT00621686|B1|Baseline|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556708|NCT00621686|P2|Participant Flow|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556709|NCT00621686|P1|Participant Flow|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556710|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556711|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556712|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556713|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556714|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556715|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556716|NCT00621686|E2|Reported Event|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556717|NCT00621686|E1|Reported Event|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
556718|NCT00621621|B4|Baseline|Total|Total of all reporting groups
556719|NCT00621621|B3|Baseline|Subjects Collected From Published Data|Published evidence about the safety and efficacy of using Medtronic’s Freezor® 4 mm CryoCatheter has been reported since the initiation of the CryoFACTS-PAS. The results reported in the literature provide the supplemental data in the same study population as in the PAS and are included to meet the study objectives, as agreed upon with the FDA.
556720|NCT00621621|B2|Baseline|Subjects Consented in the Study Not Ablated|Actual Subjects that were consented in the study that did not meet inclusion criteria.
556721|NCT00621621|B1|Baseline|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
556722|NCT00621621|P2|Participant Flow|External Data Supporting the Study|Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
556723|NCT00621621|P1|Participant Flow|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
556724|NCT00621621|O2|Outcome|External Data Supporting the Study|This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
556725|NCT00621621|O1|Outcome|Experimental: Freezor Catheter for AVNRT|Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmiacryoablation
556726|NCT00621621|O2|Outcome|External Data Supporting the Study|
556727|NCT00621621|O1|Outcome|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
556728|NCT00621621|E2|Reported Event|External Data Supporting the Study|"Subjects from publication search with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
556729|NCT00621621|E1|Reported Event|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
556730|NCT00621582|B1|Baseline|Tiotropium Bromide|
556731|NCT00621582|P1|Participant Flow|Tiotropium Bromide|
556732|NCT00621582|O1|Outcome|Tiotropium Bromide|
556733|NCT00621582|O1|Outcome|Tiotropium Bromide|
556734|NCT00621582|O1|Outcome|Tiotropium Bromide|
556735|NCT00621582|O1|Outcome|Tiotropium Bromide|
556736|NCT00621582|E1|Reported Event|Tiotropium Bromide|
556737|NCT00621543|B1|Baseline|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
556738|NCT00621543|P1|Participant Flow|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
556739|NCT00621543|O1|Outcome|Single Arm Study|
556740|NCT00621543|O1|Outcome|Single Arm Study|
556743|NCT00621530|B2|Baseline|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
556744|NCT00621530|B1|Baseline|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
556745|NCT00621530|P2|Participant Flow|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
556746|NCT00621530|P1|Participant Flow|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
556747|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
556748|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution 2 mg added to the patient's routine spinal anesthetic for surgery
556749|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
556750|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
556751|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
556752|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
556753|NCT00621530|O2|Outcome|Placebo|sterile saline placebo added to the patient's routine spinal anesthetic for surgery
556754|NCT00621530|O1|Outcome|Ketorolac|ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
556755|NCT00621530|O2|Outcome|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
556756|NCT00621530|O1|Outcome|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
556757|NCT00621530|E2|Reported Event|Placebo|"placebo will be added to the patient's routine spinal anesthetic for surgery~placebo: placebo will be added to the patient's routine spinal anesthetic for surgery"
556758|NCT00621530|E1|Reported Event|Ketorolac|"ketorolac 2 mg~ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery"
556759|NCT00621517|B3|Baseline|Total|Total of all reporting groups
556760|NCT00621517|B2|Baseline|Placebo|Participants will receive matching placebo capsule nightly.
556761|NCT00621517|B1|Baseline|Bupropion|Participants will receive 150MG Bupropion nightly.
556762|NCT00621517|P2|Participant Flow|Placebo|Participants will receive matching placebo capsule nightly.
556763|NCT00621517|P1|Participant Flow|Bupropion|Participants will receive 150MG Bupropion nightly.
556764|NCT00621517|O2|Outcome|Placebo|Participants will receive matching placebo capsule nightly.
556765|NCT00621517|O1|Outcome|Bupropion|Participants will receive 150MG Bupropion nightly.
556766|NCT00621517|E2|Reported Event|Placebo|Participants will receive matching placebo capsule nightly.
556767|NCT00621517|E1|Reported Event|Bupropion|Participants will receive 150MG Bupropion nightly.
556768|NCT00621504|B3|Baseline|Total|Total of all reporting groups
556769|NCT00621504|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
556770|NCT00621504|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
556771|NCT00621504|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
556772|NCT00621504|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
556773|NCT00621504|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
556774|NCT00621504|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
556775|NCT00621504|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
556776|NCT00621504|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
556777|NCT00621348|B4|Baseline|Total|Total of all reporting groups
556778|NCT00621348|B3|Baseline|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
556779|NCT00621348|B2|Baseline|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
556780|NCT00621348|B1|Baseline|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
556781|NCT00621348|P3|Participant Flow|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
556782|NCT00621348|P2|Participant Flow|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
556783|NCT00621348|P1|Participant Flow|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
556784|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
556785|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
556786|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
556787|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
556788|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
556789|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
556790|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
557543|NCT00619970|O2|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
556791|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
556792|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
556793|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
556794|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
556795|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
556796|NCT00621348|E3|Reported Event|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
556797|NCT00621348|E2|Reported Event|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
556798|NCT00621348|E1|Reported Event|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
556799|NCT00621322|B7|Baseline|Total|Total of all reporting groups
556800|NCT00621322|B6|Baseline|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556801|NCT00621322|B5|Baseline|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556802|NCT00621322|B4|Baseline|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556803|NCT00621322|B3|Baseline|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556804|NCT00621322|B2|Baseline|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556805|NCT00621322|B1|Baseline|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556806|NCT00621322|P6|Participant Flow|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556807|NCT00621322|P5|Participant Flow|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556808|NCT00621322|P4|Participant Flow|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556809|NCT00621322|P3|Participant Flow|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556810|NCT00621322|P2|Participant Flow|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556811|NCT00621322|P1|Participant Flow|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556812|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556813|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556814|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556815|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556816|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556817|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556818|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556819|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556820|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556821|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556822|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556823|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556824|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556825|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556826|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556827|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556828|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556829|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556830|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556831|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556832|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556833|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556834|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556835|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556836|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556837|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556838|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556839|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556840|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556922|NCT00621244|P2|Participant Flow|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
556841|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556842|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556843|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556844|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556845|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556846|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556847|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556848|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556849|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556850|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556851|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556852|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556853|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556854|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556855|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556856|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556857|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556858|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556859|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556860|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556861|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556862|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556968|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556969|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556863|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556864|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556865|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556866|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556867|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556868|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556869|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556870|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556871|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556872|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556873|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556874|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556875|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556876|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556877|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556878|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556879|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556880|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556881|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556882|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556883|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556884|NCT00621322|E6|Reported Event|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556970|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556971|NCT00621244|O6|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556885|NCT00621322|E5|Reported Event|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556886|NCT00621322|E4|Reported Event|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556887|NCT00621322|E3|Reported Event|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556888|NCT00621322|E2|Reported Event|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556889|NCT00621322|E1|Reported Event|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
556890|NCT00621296|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
556891|NCT00621296|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
556892|NCT00621296|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
556893|NCT00621296|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
556894|NCT00621257|B6|Baseline|Total|Total of all reporting groups
556895|NCT00621257|B5|Baseline|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
556896|NCT00621257|B4|Baseline|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
556897|NCT00621257|B3|Baseline|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
556898|NCT00621257|B2|Baseline|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
556899|NCT00621257|B1|Baseline|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
556900|NCT00621257|P5|Participant Flow|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
556901|NCT00621257|P4|Participant Flow|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
556902|NCT00621257|P3|Participant Flow|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
556903|NCT00621257|P2|Participant Flow|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
556904|NCT00621257|P1|Participant Flow|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
556905|NCT00621257|O2|Outcome|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
556906|NCT00621257|O1|Outcome|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
556907|NCT00621257|O3|Outcome|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
556908|NCT00621257|O2|Outcome|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
556909|NCT00621257|O1|Outcome|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
556910|NCT00621257|E5|Reported Event|Maintenance B|"1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April~ergocalciferol 8000 IU/ml"
556911|NCT00621257|E4|Reported Event|Maintenance A|"400 IU per day of oral vitamin D2~ergocalciferol 8000 IU/ml"
556912|NCT00621257|E3|Reported Event|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
556913|NCT00621257|E2|Reported Event|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
556914|NCT00621257|E1|Reported Event|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
556915|NCT00621244|B5|Baseline|Total|Total of all reporting groups
556916|NCT00621244|B4|Baseline|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
556917|NCT00621244|B3|Baseline|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556918|NCT00621244|B2|Baseline|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
556919|NCT00621244|B1|Baseline|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556920|NCT00621244|P4|Participant Flow|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
556921|NCT00621244|P3|Participant Flow|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556923|NCT00621244|P1|Participant Flow|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556924|NCT00621244|O7|Outcome|Arm 2, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556925|NCT00621244|O6|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
556926|NCT00621244|O5|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
556927|NCT00621244|O4|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
556928|NCT00621244|O3|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
556929|NCT00621244|O2|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
556930|NCT00621244|O1|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week.
556931|NCT00621244|O9|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556932|NCT00621244|O8|Outcome|Arm 1, Group Y (40mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556933|NCT00621244|O7|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556934|NCT00621244|O6|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556935|NCT00621244|O5|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556936|NCT00621244|O4|Outcome|Arm 1, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556937|NCT00621244|O3|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556938|NCT00621244|O2|Outcome|Arm 1, Group x (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556939|NCT00621244|O1|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week.
556940|NCT00621244|O3|Outcome|Arm 2, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556941|NCT00621244|O2|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556942|NCT00621244|O1|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556943|NCT00621244|O4|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556944|NCT00621244|O3|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556945|NCT00621244|O2|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556946|NCT00621244|O1|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556947|NCT00621244|O4|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556948|NCT00621244|O3|Outcome|Arm 1, Group Y (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556949|NCT00621244|O2|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556950|NCT00621244|O1|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556951|NCT00621244|O5|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556952|NCT00621244|O4|Outcome|Arm 1, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556953|NCT00621244|O3|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556954|NCT00621244|O2|Outcome|Arm 1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556955|NCT00621244|O1|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556956|NCT00621244|O5|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556957|NCT00621244|O4|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556958|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556959|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556960|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556961|NCT00621244|O5|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556962|NCT00621244|O4|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556963|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556964|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556965|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556966|NCT00621244|O5|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556967|NCT00621244|O4|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556972|NCT00621244|O5|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556973|NCT00621244|O4|Outcome|45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556974|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556975|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556976|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556977|NCT00621244|O6|Outcome|80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556978|NCT00621244|O5|Outcome|60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556979|NCT00621244|O4|Outcome|45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556980|NCT00621244|O3|Outcome|40 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556981|NCT00621244|O2|Outcome|30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556982|NCT00621244|O1|Outcome|20 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF)
556983|NCT00621244|O2|Outcome|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556984|NCT00621244|O1|Outcome|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556985|NCT00621244|O2|Outcome|Arm 2, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
556986|NCT00621244|O1|Outcome|Arm 1, Group Y|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication.
556987|NCT00621244|O1|Outcome|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556988|NCT00621244|O2|Outcome|Arm 2, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556989|NCT00621244|O1|Outcome|Arm 1, Group X|panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
556990|NCT00621244|O7|Outcome|Arm 2, Group Y (60 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
556991|NCT00621244|O6|Outcome|Arm 2, Group Y (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
556992|NCT00621244|O5|Outcome|Arm 2, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
556993|NCT00621244|O4|Outcome|Arm 2, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556994|NCT00621244|O3|Outcome|Arm 2, Group X (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556995|NCT00621244|O2|Outcome|Arm 2, Group X (45 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556996|NCT00621244|O1|Outcome|Arm 2, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
556997|NCT00621244|O9|Outcome|Arm 1, Group Y (60 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
556998|NCT00621244|O8|Outcome|Arm 1, Group Y (40 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
556999|NCT00621244|O7|Outcome|Arm 1, Group Y (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557000|NCT00621244|O6|Outcome|Arm 1, Group Y (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557001|NCT00621244|O5|Outcome|Arm 1, Group X (80 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557002|NCT00621244|O4|Outcome|Arm 1, Group X (60 mg) - MTD|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Groups X is a sub-arm, based on disease indication.
557003|NCT00621244|O3|Outcome|Arm 1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557004|NCT00621244|O2|Outcome|Arm 1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557005|NCT00621244|O1|Outcome|Arm 1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557006|NCT00621244|E16|Reported Event|Arm2 GroupY 60 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557007|NCT00621244|E15|Reported Event|Arm2 GroupY 45 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557008|NCT00621244|E14|Reported Event|Arm2 GroupY 30 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557009|NCT00621244|E13|Reported Event|Arm2 GroupX 80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557010|NCT00621244|E12|Reported Event|Arm2 GroupX 60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557011|NCT00621244|E11|Reported Event|Arm2 GroupX 45 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557012|NCT00621244|E10|Reported Event|Arm2 GroupX 30 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557013|NCT00621244|E9|Reported Event|Arm1 GroupY 60 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557014|NCT00621244|E8|Reported Event|Arm1 GroupY 40 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557015|NCT00621244|E7|Reported Event|Arm1 GroupY 30 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557016|NCT00621244|E6|Reported Event|Arm1 GroupY 20 mg|Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
557017|NCT00621244|E5|Reported Event|Arm1 GroupX 80 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557018|NCT00621244|E4|Reported Event|Arm1 GroupX 60 mg|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557019|NCT00621244|E3|Reported Event|Arm1, Group X (40 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557020|NCT00621244|E2|Reported Event|Arm1, Group X (30 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557021|NCT00621244|E1|Reported Event|Arm1, Group X (20 mg)|Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
557022|NCT00621192|B5|Baseline|Total|Total of all reporting groups
557023|NCT00621192|B4|Baseline|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
557024|NCT00621192|B3|Baseline|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
557025|NCT00621192|B2|Baseline|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
557026|NCT00621192|B1|Baseline|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
557027|NCT00621192|P4|Participant Flow|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
557028|NCT00621192|P3|Participant Flow|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
557029|NCT00621192|P2|Participant Flow|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
557030|NCT00621192|P1|Participant Flow|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
557031|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
557032|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
557033|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
557034|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
557035|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
557036|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
557037|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
557038|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
557039|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
557040|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
557041|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
557042|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
557043|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
557044|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
557045|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
557046|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
557047|NCT00621192|E4|Reported Event|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
557048|NCT00621192|E3|Reported Event|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
557049|NCT00621192|E2|Reported Event|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
557050|NCT00621192|E1|Reported Event|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
557051|NCT00621153|B3|Baseline|Total|Total of all reporting groups
557052|NCT00621153|B2|Baseline|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
557053|NCT00621153|B1|Baseline|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
557054|NCT00621153|P2|Participant Flow|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
557055|NCT00621153|P1|Participant Flow|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
557056|NCT00621153|O2|Outcome|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
557057|NCT00621153|O1|Outcome|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
557058|NCT00621153|E2|Reported Event|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
557059|NCT00621153|E1|Reported Event|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
557060|NCT00621140|B3|Baseline|Total|Total of all reporting groups
557061|NCT00621140|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557062|NCT00621140|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
557063|NCT00621140|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557064|NCT00621140|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
557065|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557066|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557067|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557068|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557069|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557070|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557071|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557072|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557073|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557074|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557075|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557076|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557077|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557078|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557079|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557080|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557081|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557082|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557083|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557084|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557085|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557086|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557087|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557088|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557089|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557090|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557091|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557092|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
557093|NCT00621140|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
557094|NCT00621140|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
557095|NCT00621049|B3|Baseline|Total|Total of all reporting groups
557096|NCT00621049|B2|Baseline|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
557097|NCT00621049|B1|Baseline|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
557098|NCT00621049|P2|Participant Flow|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
557327|NCT00620542|E2|Reported Event|Atorvastatin 40 mg|2 week run-in period
557099|NCT00621049|P1|Participant Flow|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
557100|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
557101|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
557102|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
557103|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
557104|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
557105|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
557106|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
557107|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
557108|NCT00621049|E2|Reported Event|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
557109|NCT00621049|E1|Reported Event|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
557110|NCT00621023|B1|Baseline|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
557111|NCT00621023|P1|Participant Flow|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
557112|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
557328|NCT00620542|E1|Reported Event|Rosuvastatin 20 mg|2 week run-in period
557329|NCT00620464|B3|Baseline|Total|Total of all reporting groups
557113|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
557114|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
557115|NCT00621023|E1|Reported Event|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
557116|NCT00620945|B1|Baseline|Phenoxybenzamine|"Treatment Group~Phenoxybenzamine: Use of Phenoxybenzamine:~Loading dose given at the time of going on CPB:~For patients with obstructing lesions on systemic side:~0.25 mg/kg dose in the bypass circuit~None intravenous~For patients without obstructing left sided lesions:~0.5 mg/kg in the bypass circuit~0.5 mg/kg I.V. at cannulation~Maintenance dose given in the post-operative period:~0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours~0.3 mg/kg P.O. every 8 hours for next 24 hours~0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop~Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group"
557117|NCT00620945|P1|Participant Flow|Phenoxybenzamine Treatment|Treatment Group- patients treated with phenoxybenzamine
557118|NCT00620945|O1|Outcome|Phenoxybenzamine Treatment|Treatment Group- patients treated with phenoxybenzamine
557119|NCT00620945|O1|Outcome|Phenoxybenzamine Treatment|Treatment Group- patients treated with phenoxybenzamine
557120|NCT00620945|E1|Reported Event|Phenoxybenzamine|"Treatment Group~Phenoxybenzamine: Use of Phenoxybenzamine:~Loading dose given at the time of going on CPB:~For patients with obstructing lesions on systemic side:~0.25 mg/kg dose in the bypass circuit~None intravenous~For patients without obstructing left sided lesions:~0.5 mg/kg in the bypass circuit~0.5 mg/kg I.V. at cannulation~Maintenance dose given in the post-operative period:~0.3 mg/kg I.V. every 8 hours till oral intake is started or for first 48 hours~0.3 mg/kg P.O. every 8 hours for next 24 hours~0.15 mg/kg P.O. every 8 hours for next 24 hours and then stop~Hold PBZ if the patient is on norepinephrine infusion or the mean arterial pressure is lower than that allowed for the age group"
557121|NCT00620854|B7|Baseline|Total|Total of all reporting groups
557122|NCT00620854|B6|Baseline|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557123|NCT00620854|B5|Baseline|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557124|NCT00620854|B4|Baseline|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557125|NCT00620854|B3|Baseline|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557126|NCT00620854|B2|Baseline|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557127|NCT00620854|B1|Baseline|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557128|NCT00620854|P6|Participant Flow|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557129|NCT00620854|P5|Participant Flow|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557130|NCT00620854|P4|Participant Flow|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557131|NCT00620854|P3|Participant Flow|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557132|NCT00620854|P2|Participant Flow|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557133|NCT00620854|P1|Participant Flow|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557134|NCT00620854|O3|Outcome|Fortical®|Fortical nasal spray (200 IU)
557135|NCT00620854|O2|Outcome|rsCTB|Oral rsCT (200 micrograms)
557136|NCT00620854|O1|Outcome|rsCT A|Oral rsCT (150 micrograms)
557137|NCT00620854|E6|Reported Event|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557138|NCT00620854|E5|Reported Event|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557139|NCT00620854|E4|Reported Event|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557140|NCT00620854|E3|Reported Event|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557544|NCT00619970|O1|Outcome|Healthy Control|Healthy controls
557141|NCT00620854|E2|Reported Event|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557142|NCT00620854|E1|Reported Event|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
557143|NCT00620828|B3|Baseline|Total|Total of all reporting groups
557144|NCT00620828|B2|Baseline|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
557145|NCT00620828|B1|Baseline|Control Group|Subjects receive intra-op saline injection per protocol
557146|NCT00620828|P2|Participant Flow|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
557147|NCT00620828|P1|Participant Flow|Control Group|Subjects receive intra-op saline injection per protocol
557148|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
557149|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
557150|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
557151|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
557152|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
557153|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
557154|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
557155|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
557156|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
557157|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
557158|NCT00620828|E2|Reported Event|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
557159|NCT00620828|E1|Reported Event|Control Group|Subjects receive intra-op saline injection per protocol
557160|NCT00620815|B4|Baseline|Total|Total of all reporting groups
557161|NCT00620815|B3|Baseline|A/S-A|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557162|NCT00620815|B2|Baseline|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557163|NCT00620815|B1|Baseline|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557164|NCT00620815|P3|Participant Flow|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557165|NCT00620815|P2|Participant Flow|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557166|NCT00620815|P1|Participant Flow|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557167|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557168|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557169|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557170|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557171|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557172|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557173|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557174|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557175|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557176|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557177|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557178|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557179|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557180|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557181|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557182|NCT00620815|O6|Outcome|A/S-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
557183|NCT00620815|O5|Outcome|A/P-T: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
557184|NCT00620815|O4|Outcome|T/P-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
557185|NCT00620815|O3|Outcome|A/S-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
557186|NCT00620815|O2|Outcome|A/P-T: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
557187|NCT00620815|O1|Outcome|T/P-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
557188|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557189|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557190|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557191|NCT00620815|O6|Outcome|A/S-A: In Arm Receiving Seasonal Influenza Vaccine (S)|Local reactions after first vaccination in arm receiving seasonal influenza vaccination in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
557192|NCT00620815|O5|Outcome|A/S-A: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) bon day 22
557193|NCT00620815|O4|Outcome|A/P-T: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving Placebo in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
557194|NCT00620815|O3|Outcome|A/P-T: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine(T) on day 22
557195|NCT00620815|O2|Outcome|T/P-A: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving placebo in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
557196|NCT00620815|O1|Outcome|T/P-A: In Arm Receiving Tetravalent Vaccine (T)|Local reactions after first vaccination in arm receiving tetravalent influenza vaccine in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
557197|NCT00620815|O3|Outcome|A/S-A|One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
557198|NCT00620815|O2|Outcome|A/P-T|One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
557199|NCT00620815|O1|Outcome|T/P-A|One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
557200|NCT00620815|E3|Reported Event|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
557362|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
557201|NCT00620815|E2|Reported Event|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
557202|NCT00620815|E1|Reported Event|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
557203|NCT00620776|B3|Baseline|Total|Total of all reporting groups
557204|NCT00620776|B2|Baseline|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557205|NCT00620776|B1|Baseline|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557206|NCT00620776|P2|Participant Flow|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557207|NCT00620776|P1|Participant Flow|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557208|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557209|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557210|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557211|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557212|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557213|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557214|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557215|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557216|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557217|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557218|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557219|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557220|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557221|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557222|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557223|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557224|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557225|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557226|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557227|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557228|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557229|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557230|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557231|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557232|NCT00620776|E2|Reported Event|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
557233|NCT00620776|E1|Reported Event|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
557234|NCT00620763|B1|Baseline|Entire Study Population|Dietary Intervention: Crossover design, High meat and high potential renal acid load (high PRAL) diet and low meat and low potential renal acid load (low PRAL) diet, consumed in random order.
557235|NCT00620763|P2|Participant Flow|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
557236|NCT00620763|P1|Participant Flow|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
557237|NCT00620763|O2|Outcome|Low Meat - Low Potential Renal Acid Load|Low meat and low potential renal acid load (low PRAL) diet in either the first or second intervention period
557238|NCT00620763|O1|Outcome|High Meat - High Potential Renal Acid Load|High meat and high potential renal acid load (high PRAL) diet in either the first or second intervention period
557239|NCT00620763|E2|Reported Event|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
557240|NCT00620763|E1|Reported Event|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
557241|NCT00620750|B1|Baseline|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
557242|NCT00620750|P1|Participant Flow|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
557243|NCT00620750|O1|Outcome|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
557244|NCT00620750|E1|Reported Event|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
557245|NCT00620711|B1|Baseline|Preter Infnats With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Criteria include Sentinel evnet , Low Apgar, pH less than 7, Neonatal encephalopathy with no other cause and need for mechanical ventialtion~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
557246|NCT00620711|P1|Participant Flow|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
557247|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
557248|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
557249|NCT00620711|E1|Reported Event|Preterm Infants With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
557250|NCT00620698|B1|Baseline|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
557251|NCT00620698|P1|Participant Flow|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
557252|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
557253|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
557254|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
557255|NCT00620698|E1|Reported Event|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
557256|NCT00620659|B1|Baseline|All Randomized Participants|All participants randomized in study
557257|NCT00620659|P6|Participant Flow|Modafinil/Placebo/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
557258|NCT00620659|P5|Participant Flow|Placebo/MK0249/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
557259|NCT00620659|P4|Participant Flow|MK0249/Modafinil/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
557360|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
557361|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
557260|NCT00620659|P3|Participant Flow|Modafinil/MK0249/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
557261|NCT00620659|P2|Participant Flow|Placebo/Modafinil/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
557262|NCT00620659|P1|Participant Flow|MK0249/Placebo/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
557263|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
557264|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
557265|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
557266|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
557267|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
557268|NCT00620659|O1|Outcome|MK0249 Top 2 Doses Pooled|"The top 2 doses (the two doses to which most patients were adaptively assigned) were 10 mg and 12 mg.~There were 74 participants who received MK0249 10 and 12 mg over 3 periods (25, 22, and 27 participants for Periods 1, 2, and 3 respectively)."
557269|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
557270|NCT00620659|O1|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
557271|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
557272|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
557273|NCT00620659|E6|Reported Event|Modafinil|Modafinil was provided as 100 mg tablets.
557274|NCT00620659|E5|Reported Event|MK0249 12 mg|MK0249 was provided as 1 mg and 5 mg tablets.
557275|NCT00620659|E4|Reported Event|MK0249 10 mg|MK0249 was provided as 1 mg and 5 mg tablets.
557276|NCT00620659|E3|Reported Event|MK0249 8 mg|MK0249 was provided as 1 mg and 5 mg tablets.
557277|NCT00620659|E2|Reported Event|MK0249 5 mg|MK0249 was provided as 1 mg and 5 mg tablets.
557278|NCT00620659|E1|Reported Event|Placebo|Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
557279|NCT00620555|B1|Baseline|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
557280|NCT00620555|P1|Participant Flow|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
557281|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
557545|NCT00619970|E3|Reported Event|Children Receiving Placebo|1/3 patients with CAP
557282|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
557283|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
557284|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
557285|NCT00620555|E1|Reported Event|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
557286|NCT00620542|B3|Baseline|Total|Total of all reporting groups
557287|NCT00620542|B2|Baseline|Atorvastatin 80 mg|2 years
557288|NCT00620542|B1|Baseline|Rosuvastatin 40 mg|2 years
557289|NCT00620542|P4|Participant Flow|Atorvastatin 80 mg|2 year core study
557290|NCT00620542|P3|Participant Flow|Rosuvastatin 40 mg|2 year core study
557291|NCT00620542|P2|Participant Flow|Atorvastatin 40 mg|2 week run-in period
557292|NCT00620542|P1|Participant Flow|Rosuvastatin 20 mg|2 week run-in period
557293|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557294|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557295|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557296|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557297|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557298|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557299|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557300|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557301|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557302|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557303|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557304|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557305|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557306|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557307|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557308|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557309|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557310|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557311|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557312|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557313|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557314|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557315|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557316|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557317|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557318|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557319|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557320|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557321|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557322|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557323|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
557324|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
557325|NCT00620542|E4|Reported Event|Atorvastatin 80 mg|2 year core study
557326|NCT00620542|E3|Reported Event|Rosuvastatin 40 mg|2 year core study
557330|NCT00620464|B2|Baseline|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
557331|NCT00620464|B1|Baseline|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
557332|NCT00620464|P2|Participant Flow|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
557333|NCT00620464|P1|Participant Flow|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
557334|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
557335|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
557336|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
557337|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
557338|NCT00620464|E2|Reported Event|Radiopaque Implanon|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
557339|NCT00620464|E1|Reported Event|Implanon|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
557340|NCT00620425|B1|Baseline|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
557341|NCT00620425|P1|Participant Flow|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
557342|NCT00620425|O8|Outcome|72 hr Post-dose|Only 3 subjects were required to return on Day 4. Day 4 assessments included a 72 hour assessment for the first and second injections and a 48 hour assessment for the third injection.
557343|NCT00620425|O7|Outcome|48 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
557344|NCT00620425|O6|Outcome|24 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
557345|NCT00620425|O5|Outcome|8 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
557346|NCT00620425|O4|Outcome|4 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
557347|NCT00620425|O3|Outcome|1 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
557348|NCT00620425|O2|Outcome|All Participants Immediately Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
557349|NCT00620425|O1|Outcome|All Participants at -15 Min Pre-dose|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
557350|NCT00620425|E1|Reported Event|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
557351|NCT00620373|B1|Baseline|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
557352|NCT00620373|P1|Participant Flow|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
557353|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
557354|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
557355|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
557356|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
557357|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
557358|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
557359|NCT00620373|O1|Outcome|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
557363|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
557364|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
557365|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
557366|NCT00620373|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
557367|NCT00620282|B4|Baseline|Total|Total of all reporting groups
557368|NCT00620282|B3|Baseline|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557369|NCT00620282|B2|Baseline|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557370|NCT00620282|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557371|NCT00620282|P3|Participant Flow|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557372|NCT00620282|P2|Participant Flow|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557373|NCT00620282|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557374|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557375|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557376|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557377|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557378|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557379|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557380|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557381|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557382|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557383|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557384|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557385|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557386|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557387|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557388|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557389|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557390|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557391|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557392|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557393|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557394|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557395|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557396|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557397|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557398|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557399|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557400|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557401|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557402|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557403|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557404|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557405|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557406|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557407|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557494|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
557408|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557409|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557410|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557411|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557412|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557413|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557414|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557415|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557416|NCT00620282|E3|Reported Event|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
557417|NCT00620282|E2|Reported Event|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557418|NCT00620282|E1|Reported Event|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
557419|NCT00620126|B3|Baseline|Total|Total of all reporting groups
557420|NCT00620126|B2|Baseline|Control|Best Available Care
557421|NCT00620126|B1|Baseline|Intervention|UC Home Automated Telemanagement
557422|NCT00620126|P2|Participant Flow|Best Available Care|The standard of care for participants in this study is modeled after the standard of care at our institution, and based on current evidence-based guidelines including comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. We expanded the care received by controls to make the groups more comparable. First, we provided the control group with all currently available educational fact sheets from the Crohn’s and Colitis Foundation at the time of group allocation. Second, we provided the control group with individualized written action plans at the time of group assignment without reinforcement.
557423|NCT00620126|P1|Participant Flow|UC Home Automated Telemanagement|The UC HAT home unit consists of a netbook computer and an electronic weight scale. Participants answer questions regarding symptoms, side effects, adherence, and receive disease-specific education using the home unit. The home unit automatically transmits the results to the decision support server after each self-testing session. Participants completed self-testing weekly. Updated action plans are automatically transmitted to participant home units if certain criteria are met. If certain clinical conditions are met, email alerts are sent to the nurse coordinator. The coordinator reviews the information and if necessary consults the medical provider and the participant for management changes.
557424|NCT00620126|O2|Outcome|Control|Best Available Care
557425|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
557426|NCT00620126|O2|Outcome|Control|Best Available Care
557427|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
557428|NCT00620126|O2|Outcome|Control|Best Available Care
557429|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
557430|NCT00620126|E2|Reported Event|Control|Best Available Care
557431|NCT00620126|E1|Reported Event|Intervention|UC Home Automated Telemanagement
557432|NCT00620113|B5|Baseline|Total|Total of all reporting groups
557433|NCT00620113|B4|Baseline|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557434|NCT00620113|B3|Baseline|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557435|NCT00620113|B2|Baseline|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557436|NCT00620113|B1|Baseline|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557437|NCT00620113|P4|Participant Flow|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557438|NCT00620113|P3|Participant Flow|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557439|NCT00620113|P2|Participant Flow|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557495|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
557440|NCT00620113|P1|Participant Flow|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557441|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557442|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557443|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557444|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557445|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557446|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557447|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557448|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557449|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557450|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557451|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557452|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557453|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557454|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557455|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557456|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557457|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557532|NCT00619983|E1|Reported Event|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557533|NCT00619970|B4|Baseline|Total|Total of all reporting groups
557534|NCT00619970|B3|Baseline|Children Receiving Placebo|1/3 patients with CAP
557458|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557459|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557460|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557461|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557462|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557463|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557464|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557465|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557466|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557467|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557468|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557469|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557470|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557471|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557472|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557473|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557474|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557475|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557535|NCT00619970|B2|Baseline|Children Receiving Rifaximin|2/3 Patients with CAP
557536|NCT00619970|B1|Baseline|Healthy Control|Healthy controls
557537|NCT00619970|P3|Participant Flow|Children Receiving Placebo|1/3 patients with CAP
557538|NCT00619970|P2|Participant Flow|Children Receiving Rifaximin|2/3 Patients with CAP
557476|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557477|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557478|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557479|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557480|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557481|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557482|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557483|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557484|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557485|NCT00620113|E4|Reported Event|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557486|NCT00620113|E3|Reported Event|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557487|NCT00620113|E2|Reported Event|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557488|NCT00620113|E1|Reported Event|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
557489|NCT00620074|B1|Baseline|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
557490|NCT00620074|P1|Participant Flow|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
557491|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
557492|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
557493|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
557539|NCT00619970|P1|Participant Flow|Healthy Control|Healthy controls
557496|NCT00620074|E1|Reported Event|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
557497|NCT00620035|B1|Baseline|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557498|NCT00620035|P1|Participant Flow|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557499|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557500|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557501|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557502|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557503|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557504|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557505|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557540|NCT00619970|O2|Outcome|Children Receiving Placebo|1/3 patients with CAP
557541|NCT00619970|O1|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
557506|NCT00620035|E1|Reported Event|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
557507|NCT00620022|B1|Baseline|Entire Study Population|The entire study population includes the group of patients who received indacaterol 300 μg in the first treatment period followed by placebo in the second treatment period and the group of patients who received placebo in the first treatment period followed by indacaterol 300 μg in the second treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557508|NCT00620022|P2|Participant Flow|Placebo Followed by Indacaterol 300 μg|Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557509|NCT00620022|P1|Participant Flow|Indacaterol 300 μg Followed by Placebo|Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557510|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557511|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557512|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557513|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557514|NCT00620022|E2|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557515|NCT00620022|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
557516|NCT00619983|B5|Baseline|Total|Total of all reporting groups
557517|NCT00619983|B4|Baseline|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557518|NCT00619983|B3|Baseline|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557519|NCT00619983|B2|Baseline|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557520|NCT00619983|B1|Baseline|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557521|NCT00619983|P4|Participant Flow|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557522|NCT00619983|P3|Participant Flow|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557523|NCT00619983|P2|Participant Flow|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557524|NCT00619983|P1|Participant Flow|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557525|NCT00619983|O4|Outcome|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557526|NCT00619983|O3|Outcome|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557527|NCT00619983|O2|Outcome|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557528|NCT00619983|O1|Outcome|Donepezil|Donepezil 5 mg /day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557529|NCT00619983|E4|Reported Event|Placebo|Placebo from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557530|NCT00619983|E3|Reported Event|Donepezil + Duloxetine|Donepezil 2.5 mg /day and duloxetine 30 mg / day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557531|NCT00619983|E2|Reported Event|Duloxetine|Duloxetine 30 mg twice per day from 2-14 weeks with gabapentin titrated beginning at week 8 and maintained until week 15.
557542|NCT00619970|O3|Outcome|Children Receiving Placebo|1/3 patients with CAP
557546|NCT00619970|E2|Reported Event|Children Receiving Rifaximin|2/3 Patients with CAP
557547|NCT00619970|E1|Reported Event|Healthy Control|Healthy controls
557548|NCT00619957|B3|Baseline|Total|Total of all reporting groups
557549|NCT00619957|B2|Baseline|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557550|NCT00619957|B1|Baseline|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557551|NCT00619957|P2|Participant Flow|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557552|NCT00619957|P1|Participant Flow|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557553|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557554|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557555|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557556|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557557|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557558|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557559|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557560|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557561|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557562|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557563|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557564|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557565|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557566|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557567|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557568|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557569|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557570|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557571|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557572|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557573|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557574|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557575|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557576|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557577|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557578|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557579|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557580|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557581|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557582|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557583|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557584|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557585|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557586|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557587|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557588|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557589|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557590|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557591|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557592|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557593|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557594|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557595|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557596|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557597|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557598|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557599|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557600|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557601|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557602|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557603|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557604|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557605|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557606|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557607|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557608|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557609|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557610|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557611|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557612|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557613|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557614|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557615|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557616|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557617|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557618|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557619|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557620|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557621|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557622|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557623|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557624|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557625|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
557626|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
557627|NCT00619957|E4|Reported Event|Risedronate Year 4|Risedronate 35 mg tablet once weekly Years 1 thru 4
557628|NCT00619957|E3|Reported Event|Placebo-Risedronate Year 4|Placebo once weekly Years 1 & 2 followed by risedronate 35 mg once weekly Years 3 & 4
557629|NCT00619957|E2|Reported Event|Risedronate Year 2|Risedronate 35 mg tablet once weekly Years 1 & 2
557630|NCT00619957|E1|Reported Event|Placebo Year 2|Placebo tablet once weekly Years 1 & 2
557631|NCT00619918|B3|Baseline|Total|Total of all reporting groups
557632|NCT00619918|B2|Baseline|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557633|NCT00619918|B1|Baseline|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557634|NCT00619918|P2|Participant Flow|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557635|NCT00619918|P1|Participant Flow|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557636|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557872|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557637|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557638|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557639|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557640|NCT00619918|E2|Reported Event|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557641|NCT00619918|E1|Reported Event|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
557642|NCT00619892|B3|Baseline|Total|Total of all reporting groups
557643|NCT00619892|B2|Baseline|Placebo|Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
557644|NCT00619892|B1|Baseline|Quetiapine|Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
557645|NCT00619892|P2|Participant Flow|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
557646|NCT00619892|P1|Participant Flow|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
557647|NCT00619892|O2|Outcome|Placebo|"Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication."
557648|NCT00619892|O1|Outcome|Quetiapine XR|"Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy & the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, & 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~quetiapine XR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg."
557649|NCT00619892|O2|Outcome|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
557650|NCT00619892|O1|Outcome|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
557651|NCT00619892|E2|Reported Event|Placebo Group|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
557652|NCT00619892|E1|Reported Event|Quietapine Group|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
557653|NCT00619827|B3|Baseline|Total|Total of all reporting groups
557654|NCT00619827|B2|Baseline|Placebo|Placebo tablet
557655|NCT00619827|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
557656|NCT00619827|P2|Participant Flow|Placebo|Placebo tablet
557657|NCT00619827|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
557658|NCT00619827|O2|Outcome|Placebo|Placebo tablet
557659|NCT00619827|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
557660|NCT00619827|E2|Reported Event|Placebo|Placebo tablet
557661|NCT00619827|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
557662|NCT00619801|B3|Baseline|Total|Total of all reporting groups
557663|NCT00619801|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557664|NCT00619801|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557665|NCT00619801|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557666|NCT00619801|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557667|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557668|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557669|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557670|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557873|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557671|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557672|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557673|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557674|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557675|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557676|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557677|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557678|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557679|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557680|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557681|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557682|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557683|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557684|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557685|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557686|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557687|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557688|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557689|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557690|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557691|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557692|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557693|NCT00619801|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557694|NCT00619801|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
557695|NCT00619762|B1|Baseline|LTN - Porcine Acellulare Dermal Matrix in Breast Recon|This was a single arm sudy without a control arm LTM used to reinforce weak tissue in breast reconstruction surgery
557696|NCT00619762|P1|Participant Flow|LTM - Porcine Acellular Dermal Matrix in Breast Reconstruct|"This was a single arm sudy without a control arm~Use of LTM to reinforce weak tissue in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction."
557697|NCT00619762|O1|Outcome|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
557698|NCT00619762|O1|Outcome|Treatment Arm|all available patients/breasts who completed specified visit
557699|NCT00619762|E1|Reported Event|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
557700|NCT00619723|B3|Baseline|Total|Total of all reporting groups
557701|NCT00619723|B2|Baseline|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557702|NCT00619723|B1|Baseline|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557703|NCT00619723|P2|Participant Flow|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557704|NCT00619723|P1|Participant Flow|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557705|NCT00619723|O2|Outcome|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557706|NCT00619723|O1|Outcome|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557707|NCT00619723|O2|Outcome|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557725|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
557874|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557708|NCT00619723|O1|Outcome|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557709|NCT00619723|O2|Outcome|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557710|NCT00619723|O1|Outcome|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557711|NCT00619723|E2|Reported Event|Placebo|"Participants will receive placebo identical in appearance to Citicoline throughout the study. Placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Placebo: Inactive ingredient matching the active medication in appearance.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557712|NCT00619723|E1|Reported Event|Citicoline|"Participants will receive active medication throughout the study. Citicoline will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects.~Citicoline: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.~Cognitive Behavioral Therapy (CBT): Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT."
557713|NCT00619684|B1|Baseline|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557714|NCT00619684|P1|Participant Flow|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557715|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557716|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557717|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557718|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557719|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557720|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557721|NCT00619684|E1|Reported Event|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
557722|NCT00619645|B1|Baseline|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
557723|NCT00619645|P1|Participant Flow|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
557724|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
557726|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
557727|NCT00619645|E1|Reported Event|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
557728|NCT00619619|B9|Baseline|Total|Total of all reporting groups
557729|NCT00619619|B8|Baseline|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557730|NCT00619619|B7|Baseline|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557731|NCT00619619|B6|Baseline|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557732|NCT00619619|B5|Baseline|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557733|NCT00619619|B4|Baseline|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557734|NCT00619619|B3|Baseline|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557735|NCT00619619|B2|Baseline|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557736|NCT00619619|B1|Baseline|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557737|NCT00619619|P8|Participant Flow|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557738|NCT00619619|P7|Participant Flow|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557739|NCT00619619|P6|Participant Flow|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557740|NCT00619619|P5|Participant Flow|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557741|NCT00619619|P4|Participant Flow|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557742|NCT00619619|P3|Participant Flow|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557743|NCT00619619|P2|Participant Flow|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557744|NCT00619619|P1|Participant Flow|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557745|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557746|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557747|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557748|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557749|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557750|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557751|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557752|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557753|NCT00619619|O1|Outcome|Desvenlafaxine - Combined Children and Adolescent Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels and Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
557754|NCT00619619|O2|Outcome|Desvenlafaxine – Combined Adolescent Cohorts|Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
557755|NCT00619619|O1|Outcome|Desvenlafaxine – Combined Children Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels.
557756|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557757|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557758|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557759|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557760|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557761|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557762|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557763|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557764|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557765|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557766|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557767|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557768|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557769|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557770|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557771|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557772|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557773|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557774|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557775|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557776|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557777|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557778|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557779|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557807|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557780|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557781|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557782|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557783|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557784|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557785|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557786|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557787|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557788|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557789|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557790|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557791|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557792|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557793|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557794|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557795|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557796|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557797|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557798|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557799|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557800|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557801|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557802|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557803|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557804|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557805|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557806|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557808|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557809|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557810|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557811|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557812|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557813|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557814|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557815|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557816|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557817|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557818|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557819|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557820|NCT00619619|E8|Reported Event|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
557821|NCT00619619|E7|Reported Event|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557822|NCT00619619|E6|Reported Event|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557823|NCT00619619|E5|Reported Event|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557824|NCT00619619|E4|Reported Event|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
557825|NCT00619619|E3|Reported Event|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
557826|NCT00619619|E2|Reported Event|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
557827|NCT00619619|E1|Reported Event|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
557828|NCT00619502|B3|Baseline|Total|Total of all reporting groups
557829|NCT00619502|B2|Baseline|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
557830|NCT00619502|B1|Baseline|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
557831|NCT00619502|P2|Participant Flow|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
557832|NCT00619502|P1|Participant Flow|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
557833|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
557834|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP-T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
558235|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
557835|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
557836|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
557837|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
557838|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
557839|NCT00619502|E2|Reported Event|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
557840|NCT00619502|E1|Reported Event|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
557841|NCT00619489|B3|Baseline|Total|Total of all reporting groups
557842|NCT00619489|B2|Baseline|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557843|NCT00619489|B1|Baseline|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557844|NCT00619489|P2|Participant Flow|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557845|NCT00619489|P1|Participant Flow|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557846|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557847|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557848|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557849|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557850|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557851|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557852|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557853|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557854|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557855|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557856|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557857|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557858|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557859|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557860|NCT00619489|E2|Reported Event|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557861|NCT00619489|E1|Reported Event|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
557862|NCT00619476|B5|Baseline|Total|Total of all reporting groups
557863|NCT00619476|B4|Baseline|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557864|NCT00619476|B3|Baseline|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557865|NCT00619476|B2|Baseline|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557866|NCT00619476|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557867|NCT00619476|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557868|NCT00619476|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557869|NCT00619476|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557870|NCT00619476|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557871|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557875|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557876|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557877|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557878|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557879|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557880|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557881|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557882|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557883|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557884|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557885|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557886|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557887|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557888|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557889|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557890|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557891|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557892|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557893|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557894|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557895|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557896|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557897|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557898|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557899|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557900|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557901|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557902|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557903|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557904|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557905|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557906|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557907|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557908|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557909|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557910|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557911|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557912|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557913|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557914|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557915|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557916|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557917|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557918|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557919|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557920|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557921|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557922|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557923|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557924|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557925|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557926|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557927|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557928|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557929|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557930|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557931|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557932|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557933|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557934|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557935|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557936|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557937|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557938|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557939|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557940|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557941|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557942|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557943|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557944|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557945|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557946|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557947|NCT00619476|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
557948|NCT00619476|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
557949|NCT00619476|E2|Reported Event|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
557950|NCT00619476|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
557951|NCT00619385|B4|Baseline|Total|Total of all reporting groups
557952|NCT00619385|B3|Baseline|Proellex 200 mg|"Proellex 200 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
557953|NCT00619385|B2|Baseline|Proellex 150 mg|"Proellex 150 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
557954|NCT00619385|B1|Baseline|Proellex 100 mg|"Proellex 100 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
557955|NCT00619385|P3|Participant Flow|Proellex 200 mg|Proellex 200 mg daily for 7 days
557956|NCT00619385|P2|Participant Flow|Proellex 150 mg|Proellex 150 mg daily for 7 days
557957|NCT00619385|P1|Participant Flow|Proellex 100 mg|Proellex 100 mg daily for 7 days
557958|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg vials daily for 7 days
557959|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg capsules daily for 7 days
557960|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
557961|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
557962|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg daily for 7 days vials
557963|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg daily for 7 days capsules
557964|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
557965|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
557966|NCT00619385|E3|Reported Event|Proellex 200 mg|Proellex 200 mg daily for 7 days
557967|NCT00619385|E2|Reported Event|Proellex 150 mg|Proellex 150 mg daily for 7 days
557968|NCT00619385|E1|Reported Event|Proellex 100 mg|Proellex 100 mg daily for 7 days
557969|NCT00619359|B3|Baseline|Total|Total of all reporting groups
558061|NCT00619190|E1|Reported Event|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
557970|NCT00619359|B2|Baseline|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
557971|NCT00619359|B1|Baseline|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
557972|NCT00619359|P2|Participant Flow|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
557973|NCT00619359|P1|Participant Flow|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
557974|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
557975|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
557976|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
557977|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
557978|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
557979|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
557980|NCT00619359|E2|Reported Event|Aprepitant|"Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.~6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
557981|NCT00619359|E1|Reported Event|Fosaprepitant|"Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.~4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
557982|NCT00619307|B3|Baseline|Total|Total of all reporting groups
557983|NCT00619307|B2|Baseline|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
557984|NCT00619307|B1|Baseline|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557985|NCT00619307|P2|Participant Flow|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
557986|NCT00619307|P1|Participant Flow|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557987|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
557988|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557989|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
558058|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
557990|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557991|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
557992|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557993|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
557994|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557995|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
557996|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557997|NCT00619307|E2|Reported Event|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
557998|NCT00619307|E1|Reported Event|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
557999|NCT00619255|B3|Baseline|Total|Total of all reporting groups
558000|NCT00619255|B2|Baseline|Control|Usual Care Control Condition
558001|NCT00619255|B1|Baseline|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558002|NCT00619255|P2|Participant Flow|Control|Usual Care Control Condition
558003|NCT00619255|P1|Participant Flow|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558004|NCT00619255|O2|Outcome|Control|Usual Care Control Condition
558005|NCT00619255|O1|Outcome|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558006|NCT00619255|O2|Outcome|Control|Usual Care Control Condition
558059|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
558060|NCT00619190|E2|Reported Event|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
558175|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
558007|NCT00619255|O1|Outcome|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558008|NCT00619255|O2|Outcome|Control|Usual Care Control Condition
558009|NCT00619255|O1|Outcome|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558010|NCT00619255|O2|Outcome|Control|Usual Care Control Condition
558011|NCT00619255|O1|Outcome|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558012|NCT00619255|O2|Outcome|Control|Usual Care Control Condition
558013|NCT00619255|O1|Outcome|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558014|NCT00619255|E2|Reported Event|Control|Usual Care Control Condition
558015|NCT00619255|E1|Reported Event|Intervention|"Adolescent Trauma Support Program~Adolescent Trauma Support Program: The study team will be organized into an adolescent trauma support service. The adolescent trauma support service will fundamentally restructure psychosocial care by integrating post-injury medical treatment with alcohol and PTSD detection and treatment. The adolescent trauma support specialists will deliver a stepped collaborative care intervention to adolescents and their families over the 6-12 months post-injury."
558016|NCT00619242|B1|Baseline|Sorafenib|
558017|NCT00619242|P1|Participant Flow|Sorafenib|Sorafenib 400mg BID
558018|NCT00619242|O1|Outcome|Sorafenib|
558019|NCT00619242|E1|Reported Event|Sorafenib|
558020|NCT00619229|B3|Baseline|Total|Total of all reporting groups
558021|NCT00619229|B2|Baseline|Placebo|Placebo i.v. for 15 days
558022|NCT00619229|B1|Baseline|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558023|NCT00619229|P2|Participant Flow|Placebo|Placebo i.v. for 15 days
558024|NCT00619229|P1|Participant Flow|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558025|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558026|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558027|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558028|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558029|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558030|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558031|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558032|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558033|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558034|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558035|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558036|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558037|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558038|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558039|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558040|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558041|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558042|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558043|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558044|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558045|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
558046|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558047|NCT00619229|E2|Reported Event|Placebo|Placebo i.v. for 15 days
558048|NCT00619229|E1|Reported Event|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
558049|NCT00619190|B3|Baseline|Total|Total of all reporting groups
558050|NCT00619190|B2|Baseline|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
558051|NCT00619190|B1|Baseline|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
558052|NCT00619190|P2|Participant Flow|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
558053|NCT00619190|P1|Participant Flow|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
558054|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
558055|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
558056|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
558057|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
558062|NCT00619177|B1|Baseline|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558063|NCT00619177|P1|Participant Flow|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558064|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558065|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558066|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558067|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558068|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558069|NCT00619177|E1|Reported Event|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
558070|NCT00619151|B3|Baseline|Total|Total of all reporting groups
558071|NCT00619151|B2|Baseline|St.Jude Valve|St. Jude Medical Regent Valve
558072|NCT00619151|B1|Baseline|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
558073|NCT00619151|P2|Participant Flow|St.Jude Valve|St. Jude Medical Regent Valve
558074|NCT00619151|P1|Participant Flow|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
558075|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
558076|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
558077|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
558078|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
558079|NCT00619151|E2|Reported Event|St.Jude Valve|St. Jude Medical Regent Valve
558080|NCT00619151|E1|Reported Event|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
558081|NCT00619112|B3|Baseline|Total|Total of all reporting groups
558082|NCT00619112|B2|Baseline|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558083|NCT00619112|B1|Baseline|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558084|NCT00619112|P2|Participant Flow|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558085|NCT00619112|P1|Participant Flow|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558086|NCT00619112|O2|Outcome|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558087|NCT00619112|O1|Outcome|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558088|NCT00619112|O2|Outcome|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558089|NCT00619112|O1|Outcome|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558090|NCT00619112|O2|Outcome|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558091|NCT00619112|O1|Outcome|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558092|NCT00619112|O2|Outcome|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558093|NCT00619112|O1|Outcome|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558094|NCT00619112|O2|Outcome|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558095|NCT00619112|O1|Outcome|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558096|NCT00619112|O4|Outcome|Grade III Glioma With Unmethylated MGMT|PFS of Grade III Glioma patients with unmethylated MGMT tumors
558097|NCT00619112|O3|Outcome|Grade III Glioma With Methylated MGMT|PFS of Grade III Glioma patients with methylated MGMT tumors
558098|NCT00619112|O2|Outcome|Glioblastoma With Unmethylated MGMT|PFS of Glioblastoma patients with unmethylated MGMT tumors
558099|NCT00619112|O1|Outcome|Glioblastoma With Methylated MGMT|PFS of Glioblastoma patients with methylated MGMT tumors
558100|NCT00619112|O2|Outcome|Grade III Glioma|"Grade III glioma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558101|NCT00619112|O1|Outcome|Glioblastoma|"Glioblastoma patients were treated with temozolomide at a dose of 150mg/m^2 daily for seven consecutive days of every other week.~One 28-day cycle included treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14"
558102|NCT00619112|E1|Reported Event|Temozolomide|
558103|NCT00619099|B3|Baseline|Total|Total of all reporting groups
558104|NCT00619099|B2|Baseline|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558105|NCT00619099|B1|Baseline|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558106|NCT00619099|P2|Participant Flow|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558107|NCT00619099|P1|Participant Flow|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558108|NCT00619099|O2|Outcome|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558109|NCT00619099|O1|Outcome|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558110|NCT00619099|E2|Reported Event|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558111|NCT00619099|E1|Reported Event|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
558112|NCT00619073|B1|Baseline|Entire Study Population|Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first
558113|NCT00619073|P2|Participant Flow|Placebo Then Clopidogrel|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. clopidogrel) will then be discontinued and aspirin continued for another 45 days.
558114|NCT00619073|P1|Participant Flow|Clopidogrel Then Placebo|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. placebo) will then be discontinued and aspirin continued for another 45 days.
558115|NCT00619073|O2|Outcome|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
558116|NCT00619073|O1|Outcome|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
558117|NCT00619073|E2|Reported Event|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
558118|NCT00619073|E1|Reported Event|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
558119|NCT00619060|B1|Baseline|Myristyl, Placebo|"Participants apply topical myristyl nicotinate to the and topical placebo to the other forearm once daily for 4 weeks; Myristyl, Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
558120|NCT00619060|P2|Participant Flow|Myristyl (Left), Placebo (Right)|Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
558121|NCT00619060|P1|Participant Flow|Myristyl (Right), Placebo (Left)|"Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left)Topical Myristyl Nicotinate Cream and Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
558122|NCT00619060|O2|Outcome|Topical Placebo Cream|Participants apply topical placebo cream to one forearm.
558123|NCT00619060|O1|Outcome|Myristyl Nicotinate Cream|Participants apply topical myristyl nicotinate to one forearm.
558124|NCT00619060|E4|Reported Event|Other Non-Derm Events|Systemic Other Adverse Events, i.e. Common Cold, Migraine
558125|NCT00619060|E3|Reported Event|Myristyl Forearm (Only)|Forearms receiving the Myristyl
558126|NCT00619060|E2|Reported Event|Placebo Forearm (Only)|Forearms receiving the Placebo
558127|NCT00619060|E1|Reported Event|Both Forearms|Forearms receiving the Myristyl and Placebo, both arms affected
558128|NCT00618995|B1|Baseline|Totals For Study|All participants in the study.
558129|NCT00618995|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
558130|NCT00618995|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
558131|NCT00618995|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
558132|NCT00618995|P1|Participant Flow|Sequence 1: D/C/A/B|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
558133|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
558134|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
558135|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
558136|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
558137|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
558138|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
558139|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
558140|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
558141|NCT00618995|E4|Reported Event|Placebo|Placebo once daily for 7 days
558142|NCT00618995|E3|Reported Event|Laropiprant|Laropiprant 40 mg once daily for 7 days
558143|NCT00618995|E2|Reported Event|ER Niacin|ER Niacin 2 g once daily for 7 days
558144|NCT00618995|E1|Reported Event|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
558145|NCT00618982|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558146|NCT00618982|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558147|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558148|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558149|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558150|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558151|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
558152|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
558153|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
558154|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
558155|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
558156|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
558157|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
558158|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
558159|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
558160|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
558161|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
558162|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
558163|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558164|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558165|NCT00618982|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle,600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
558166|NCT00618956|B3|Baseline|Total|Total of all reporting groups
558167|NCT00618956|B2|Baseline|Milnacipran|
558168|NCT00618956|B1|Baseline|Placebo|
558169|NCT00618956|P2|Participant Flow|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
558170|NCT00618956|P1|Participant Flow|Placebo|ITT N= 93, OC analyzed n=89
558171|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
558172|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
558173|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
558174|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
558177|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N= 93, OC analyzed n=82; hypertensive: ITT N=88, OC analyzed n=80
558178|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N= 42, OC analyzed n=37; hypertensive: ITT N=51, OC analyzed n=47
558179|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
558180|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
558181|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
558182|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
558183|NCT00618956|E2|Reported Event|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
558184|NCT00618956|E1|Reported Event|Placebo|ITT N= 93, OC analyzed n=89
558185|NCT00618839|B1|Baseline|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
558186|NCT00618839|P1|Participant Flow|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
558187|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
558188|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
558189|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
558190|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
558191|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
558192|NCT00618839|O1|Outcome|StrataGraft Skin Tissue|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
558193|NCT00618839|E1|Reported Event|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
558194|NCT00618826|B1|Baseline|Treatment Period|"Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.~Paclitaxel: Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.~Gemcitabine: Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.~Avastin: 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
558236|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558237|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558238|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558195|NCT00618826|P1|Participant Flow|Paclitaxel + Gemcitabine + Avastin|"Treatment administered once every 2 weeks, 1 cycle will consist of 14 days.~Paclitaxel (administered first) - Patients will be pre-medicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.~Gemcitabine (given after Paclitaxel) - Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.~Avastin - 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
558196|NCT00618826|O1|Outcome|Arm 1|all participants
558197|NCT00618826|O1|Outcome|Treatment|Paclitaxel / Gemcitabine
558198|NCT00618826|E1|Reported Event|Treatment Period|Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
558199|NCT00618813|B1|Baseline|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558200|NCT00618813|P1|Participant Flow|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558201|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558202|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558203|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558204|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558205|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558206|NCT00618813|E1|Reported Event|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
558207|NCT00618787|B3|Baseline|Total|Total of all reporting groups
558208|NCT00618787|B2|Baseline|COPA|Regular foam dressing without Polyhexamethylene Biguanide
558209|NCT00618787|B1|Baseline|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
558210|NCT00618787|P2|Participant Flow|COPA|Regular foam dressing without Polyhexamethylene Biguanide
558211|NCT00618787|P1|Participant Flow|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
558212|NCT00618787|O2|Outcome|COPA|Regular foam dressing without Polyhexamethylene Biguanide
558213|NCT00618787|O1|Outcome|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
558214|NCT00618787|E2|Reported Event|COPA|Regular foam dressing without Polyhexamethylene Biguanide
558215|NCT00618787|E1|Reported Event|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
558216|NCT00618774|B3|Baseline|Total|Total of all reporting groups
558217|NCT00618774|B2|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558218|NCT00618774|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558219|NCT00618774|P2|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558220|NCT00618774|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558221|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558222|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558223|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558224|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558225|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558226|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558227|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558228|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558229|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558230|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558231|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558232|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558233|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558234|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558239|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558240|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558241|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558242|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558243|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558244|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558245|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558246|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558247|NCT00618774|E2|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558248|NCT00618774|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
558249|NCT00618748|B4|Baseline|Total|Total of all reporting groups
558250|NCT00618748|B3|Baseline|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558251|NCT00618748|B2|Baseline|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558252|NCT00618748|B1|Baseline|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558253|NCT00618748|P3|Participant Flow|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558254|NCT00618748|P2|Participant Flow|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558255|NCT00618748|P1|Participant Flow|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558256|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558257|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558258|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558259|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558260|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558261|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558262|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558263|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558264|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558265|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558266|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558267|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558268|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558269|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558270|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558271|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558272|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558273|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558274|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558275|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558276|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558277|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558278|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558279|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558280|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558281|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558282|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558283|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558284|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558285|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558286|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558287|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558288|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558289|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558290|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558291|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558292|NCT00618748|E3|Reported Event|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
558293|NCT00618748|E2|Reported Event|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558294|NCT00618748|E1|Reported Event|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
558295|NCT00618722|B5|Baseline|Total|Total of all reporting groups
558296|NCT00618722|B4|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558297|NCT00618722|B3|Baseline|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558298|NCT00618722|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558299|NCT00618722|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558300|NCT00618722|P4|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558301|NCT00618722|P3|Participant Flow|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558302|NCT00618722|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558303|NCT00618722|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558304|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558305|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558306|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558307|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558308|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558309|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558310|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558311|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558312|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558313|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558314|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558315|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558316|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558317|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558318|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558319|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558320|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558321|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558322|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558323|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558324|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558325|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558326|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558327|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558328|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558329|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558330|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558331|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558332|NCT00618722|E4|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558333|NCT00618722|E3|Reported Event|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558334|NCT00618722|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558335|NCT00618722|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558336|NCT00618618|B5|Baseline|Total|Total of all reporting groups
558337|NCT00618618|B4|Baseline|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558338|NCT00618618|B3|Baseline|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558339|NCT00618618|B2|Baseline|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558340|NCT00618618|B1|Baseline|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558341|NCT00618618|P4|Participant Flow|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558342|NCT00618618|P3|Participant Flow|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558343|NCT00618618|P2|Participant Flow|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558441|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
558344|NCT00618618|P1|Participant Flow|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558345|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558346|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558347|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558348|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558349|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558350|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558351|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558352|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558353|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558354|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558355|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558356|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558357|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558358|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558359|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558360|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558361|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558362|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558363|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558364|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558365|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558366|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558367|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558368|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558369|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558370|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558371|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558372|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558373|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558374|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558375|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558376|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558377|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558378|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558379|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558380|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558381|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558382|NCT00618618|O3|Outcome|0Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558383|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558384|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558385|NCT00618618|E4|Reported Event|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558386|NCT00618618|E3|Reported Event|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558387|NCT00618618|E2|Reported Event|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558388|NCT00618618|E1|Reported Event|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
558389|NCT00618540|B1|Baseline|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558390|NCT00618540|P1|Participant Flow|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558391|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558409|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558410|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558392|NCT00618540|O1|Outcome|Alemtuzumab|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558393|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558394|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558395|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558396|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558397|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558398|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558399|NCT00618540|E1|Reported Event|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
558400|NCT00618514|B3|Baseline|Total|Total of all reporting groups
558401|NCT00618514|B2|Baseline|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558402|NCT00618514|B1|Baseline|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558403|NCT00618514|P3|Participant Flow|Bright Tip Laser & Bare Tip Laser|Subjects that received testament of both limbs using the investigational device (Bright Tip laser) and the control (bare tip laser)
558404|NCT00618514|P2|Participant Flow|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this arm had only one limb treated with the bare tip laser fiber (control).
558405|NCT00618514|P1|Participant Flow|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this category had only one limb treated with the Bright tip laser fiber.
558406|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558407|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558408|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558440|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
558411|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558412|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558413|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558414|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558415|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558416|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558417|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558418|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558419|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558420|NCT00618514|E2|Reported Event|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558421|NCT00618514|E1|Reported Event|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
558422|NCT00618449|B3|Baseline|Total|Total of all reporting groups
558423|NCT00618449|B2|Baseline|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558424|NCT00618449|B1|Baseline|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558425|NCT00618449|P2|Participant Flow|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558426|NCT00618449|P1|Participant Flow|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558427|NCT00618449|O2|Outcome|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558428|NCT00618449|O1|Outcome|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558429|NCT00618449|E2|Reported Event|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558430|NCT00618449|E1|Reported Event|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
558431|NCT00618436|B3|Baseline|Total|Total of all reporting groups
558432|NCT00618436|B2|Baseline|Phenytoin|This group will receive treatment with Phenytoin.
558433|NCT00618436|B1|Baseline|Levetiracetam|This group will receive treatment with Levetiracetam.
558434|NCT00618436|P2|Participant Flow|Phenytoin|This group will receive treatment with Phenytoin.
558435|NCT00618436|P1|Participant Flow|Levetiracetam|This group will receive treatment with Levetiracetam.
558436|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
558437|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
558438|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
558439|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
558442|NCT00618436|E2|Reported Event|Phenytoin|This group will receive treatment with Phenytoin.
558443|NCT00618436|E1|Reported Event|Levetiracetam|This group will receive treatment with Levetiracetam.
558444|NCT00618410|B1|Baseline|Entire Study Population|Study population includes subjects receiving interventions in either order.
558445|NCT00618410|P2|Participant Flow|Placebo, Then Carbon Dioxide|"Intervention sequence:~Intervention #1: nasal placebo administered 30 minutes prior to nasal challenge~Intervention #2: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge"
558446|NCT00618410|P1|Participant Flow|Carbon Dioxide, Then Placebo|"Intervention sequence:~Intervention #1: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge~Intervention #2: nasal placebo administered 30 minutes prior to nasal challenge"
558447|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
558448|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
558449|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
558450|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
558451|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
558452|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
558453|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
558454|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
558455|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
558456|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
558457|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
558458|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
558459|NCT00618410|E2|Reported Event|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
558460|NCT00618410|E1|Reported Event|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
558461|NCT00618371|B1|Baseline|Group 1|Group receiving raltegravir
558462|NCT00618371|P1|Participant Flow|Group 1|group to be treated with raltegravir
558463|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification. Samples from 0 participants were analyzed No Patients experienced ≥ 1 log decline in viral RNA, so no samples could be analyzed
558464|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification
558465|NCT00618371|E1|Reported Event|Group 1|group treated with raltegravir
558466|NCT00618332|B3|Baseline|Total|Total of all reporting groups
558467|NCT00618332|B2|Baseline|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558468|NCT00618332|B1|Baseline|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558469|NCT00618332|P2|Participant Flow|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558470|NCT00618332|P1|Participant Flow|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558471|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558472|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558473|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558474|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558475|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558476|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558477|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558478|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558479|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558480|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558481|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558482|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558483|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558484|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558485|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558486|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558487|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558488|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558489|NCT00618332|E2|Reported Event|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
558490|NCT00618332|E1|Reported Event|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
558491|NCT00618072|B4|Baseline|Total|Total of all reporting groups
558535|NCT00617981|E2|Reported Event|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
558492|NCT00618072|B3|Baseline|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
558493|NCT00618072|B2|Baseline|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
558494|NCT00618072|B1|Baseline|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
558495|NCT00618072|P3|Participant Flow|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558496|NCT00618072|P2|Participant Flow|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558497|NCT00618072|P1|Participant Flow|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558498|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558499|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558500|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558501|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558502|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558503|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558504|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558505|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558506|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558507|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558508|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558509|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558510|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558511|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558604|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558512|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558513|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558514|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558515|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558516|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558517|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558518|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558519|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558520|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558521|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558522|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558523|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558524|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
558525|NCT00618072|E3|Reported Event|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
558526|NCT00618072|E2|Reported Event|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone placebo 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
558527|NCT00618072|E1|Reported Event|A: EMPOWIR and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
558528|NCT00617981|B3|Baseline|Total|Total of all reporting groups
558529|NCT00617981|B2|Baseline|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
558530|NCT00617981|B1|Baseline|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
558531|NCT00617981|P2|Participant Flow|Sham + RFA|"Sham infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.~5% Dextrose Solution: Single 30 minute intravenous infusion"
558532|NCT00617981|P1|Participant Flow|ThermoDox + RFA|"ThermoDox should be administered at 50 mg/m2. The infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
558533|NCT00617981|O2|Outcome|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
558534|NCT00617981|O1|Outcome|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
558536|NCT00617981|E1|Reported Event|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
558537|NCT00617942|B3|Baseline|Total|Total of all reporting groups
558538|NCT00617942|B2|Baseline|Cohort 2|
558539|NCT00617942|B1|Baseline|Cohort 1|
558540|NCT00617942|P2|Participant Flow|Cohort 2|"Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16~Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians"
558541|NCT00617942|P1|Participant Flow|Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16~Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians"
558542|NCT00617942|O4|Outcome|Adjuvant Cohort 2|Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
558543|NCT00617942|O3|Outcome|Adjuvant Cohort 1|Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
558544|NCT00617942|O2|Outcome|Neo-adjuvant Cohort 2|Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
558545|NCT00617942|O1|Outcome|Neo-adjuvant Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
558546|NCT00617942|O2|Outcome|Cohort 2|
558547|NCT00617942|O1|Outcome|Cohort 1|
558548|NCT00617942|E4|Reported Event|Adjuvant Cohort 2|Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
558549|NCT00617942|E3|Reported Event|Adjuvant Cohort 1|Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
558550|NCT00617942|E2|Reported Event|Neo-adjuvant Cohort 2|Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
558551|NCT00617942|E1|Reported Event|Neo-adjuvant Cohort 1|"Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14~Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16"
558552|NCT00617929|B1|Baseline|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558553|NCT00617929|P1|Participant Flow|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558554|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558555|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558556|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558557|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558558|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558605|NCT00617903|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558850|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
558559|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558560|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558561|NCT00617929|E1|Reported Event|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
558562|NCT00617903|B3|Baseline|Total|Total of all reporting groups
558563|NCT00617903|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558564|NCT00617903|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558565|NCT00617903|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558566|NCT00617903|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558567|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558568|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558569|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558570|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558571|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558572|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558573|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558574|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558575|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558576|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558577|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558578|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558579|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558580|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558581|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558582|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558583|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558584|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558585|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558586|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558587|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558588|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558589|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558590|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558591|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558592|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558593|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558594|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558595|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558596|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558597|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558598|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558599|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558600|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558601|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558602|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558603|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
558606|NCT00617903|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
558607|NCT00617890|B5|Baseline|Total|Total of all reporting groups
558608|NCT00617890|B4|Baseline|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558609|NCT00617890|B3|Baseline|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558610|NCT00617890|B2|Baseline|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558611|NCT00617890|B1|Baseline|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558612|NCT00617890|P4|Participant Flow|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558613|NCT00617890|P3|Participant Flow|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558614|NCT00617890|P2|Participant Flow|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558615|NCT00617890|P1|Participant Flow|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558616|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558617|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558618|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558619|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558620|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558621|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558622|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558623|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558624|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558678|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
558679|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
558625|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558626|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558627|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558628|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558629|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558630|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558631|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558632|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558633|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558634|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558635|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558636|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558637|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558638|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558639|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558680|NCT00617851|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza virus vaccine-Strain B
558640|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558641|NCT00617890|O1|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558642|NCT00617890|E4|Reported Event|Group 3: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
558643|NCT00617890|E3|Reported Event|Group 2: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
558644|NCT00617890|E2|Reported Event|Group 1: 10mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558645|NCT00617890|E1|Reported Event|Group 1: 0.3mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
558646|NCT00617851|B5|Baseline|Total|Total of all reporting groups
558647|NCT00617851|B4|Baseline|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
558648|NCT00617851|B3|Baseline|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
558649|NCT00617851|B2|Baseline|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
558650|NCT00617851|B1|Baseline|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
558651|NCT00617851|P4|Participant Flow|Comparator Influenza Vaccine|One injection of the comparator influeza virus vaccine
558652|NCT00617851|P3|Participant Flow|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influeza virus vaccine
558653|NCT00617851|P2|Participant Flow|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influeza virus vaccine
558654|NCT00617851|P1|Participant Flow|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influeza virus vaccine
558655|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
558656|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
558657|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
558658|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
558659|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
558660|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
558661|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
558662|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
558663|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
558664|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
558665|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
558666|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
558667|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
558668|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
558669|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
558670|NCT00617851|O5|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
558671|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
558672|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
558673|NCT00617851|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
558674|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
558675|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
558676|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
558677|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
558681|NCT00617851|O5|Outcome|Comparator Influenza Vaccine (Strain A/H3N2)|One injection of the comparator influenza virus vaccine-Strain A/H3N2
558682|NCT00617851|O4|Outcome|Comparator Influenza Vaccine (Strain A/H1N1)|One injection of the comparator influenza virus vaccine-Strain A/H1N1
558683|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine-Strain B
558684|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Strain A/H3N2)|One injection of the investigational influenza virus vaccine-Strain A/H3N2
558685|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Strain A/H1N1)|One injection of the investigational influenza virus vaccine-Strain A/H1N1
558686|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
558687|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
558688|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
558689|NCT00617851|E2|Reported Event|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
558690|NCT00617851|E1|Reported Event|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
558691|NCT00617773|B1|Baseline|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558692|NCT00617773|P1|Participant Flow|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558693|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558694|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558695|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558696|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558697|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558698|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558699|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558700|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558701|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558702|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558703|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558704|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558705|NCT00617773|E1|Reported Event|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
558706|NCT00617734|B3|Baseline|Total|Total of all reporting groups
558707|NCT00617734|B2|Baseline|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558708|NCT00617734|B1|Baseline|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558709|NCT00617734|P2|Participant Flow|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 milligrams per square meter (mg/m^2) administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558710|NCT00617734|P1|Participant Flow|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 milligrams per kilogram (mg/kg) dose administered as an intravenous (IV) infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy. (4-week cycle). Treatment was continued until there was evidence of progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
558711|NCT00617734|O2|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558712|NCT00617734|O1|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558713|NCT00617734|O2|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558714|NCT00617734|O1|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558715|NCT00617734|O2|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558744|NCT00617708|E3|Reported Event|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
559318|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
558716|NCT00617734|O1|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558717|NCT00617734|O2|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558718|NCT00617734|O1|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558719|NCT00617734|O2|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558720|NCT00617734|O1|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558721|NCT00617734|O2|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558722|NCT00617734|O1|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558723|NCT00617734|O2|Outcome|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558724|NCT00617734|O1|Outcome|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558725|NCT00617734|E2|Reported Event|IMC-A12 (Cixutumumab) + Cetuximab|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour followed by cetuximab 500 mg/m^2 dose administered as an IV infusion over a period of 2 hours; this sequence was repeated once every 2 weeks (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558726|NCT00617734|E1|Reported Event|IMC-A12 (Cixutumumab)|IMC-A12 (cixutumumab) 10 mg/kg dose administered as an IV infusion over a period of 1 hour once every 2 weeks. A cycle was defined as 4 weeks of therapy (4-week cycle). Treatment was continued until there was evidence of PD, unacceptable toxicity, or withdrawal of consent.
558727|NCT00617708|B4|Baseline|Total|Total of all reporting groups
558728|NCT00617708|B3|Baseline|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
558729|NCT00617708|B2|Baseline|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558730|NCT00617708|B1|Baseline|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558731|NCT00617708|P3|Participant Flow|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
558732|NCT00617708|P2|Participant Flow|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558733|NCT00617708|P1|Participant Flow|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558734|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
558735|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558736|NCT00617708|O3|Outcome|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
558737|NCT00617708|O2|Outcome|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558738|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558739|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
558740|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558741|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558742|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
558743|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558745|NCT00617708|E2|Reported Event|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558746|NCT00617708|E1|Reported Event|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
558747|NCT00617669|B3|Baseline|Total|Total of all reporting groups
558748|NCT00617669|B2|Baseline|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558749|NCT00617669|B1|Baseline|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558750|NCT00617669|P2|Participant Flow|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558751|NCT00617669|P1|Participant Flow|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558752|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558753|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558754|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558755|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558756|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558757|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558758|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558759|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558760|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558761|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558762|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558763|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558764|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558765|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558766|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558767|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558768|NCT00617669|E2|Reported Event|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558769|NCT00617669|E1|Reported Event|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
558770|NCT00617604|B3|Baseline|Total|Total of all reporting groups
558771|NCT00617604|B2|Baseline|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558772|NCT00617604|B1|Baseline|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558773|NCT00617604|P2|Participant Flow|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558774|NCT00617604|P1|Participant Flow|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558775|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558776|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558777|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558778|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558779|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558780|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558781|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558782|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558783|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558784|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558785|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558786|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558787|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558788|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558789|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558790|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558791|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558792|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558793|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558794|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558795|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558796|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558797|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558798|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558799|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558800|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558801|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558802|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558803|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558804|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558847|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558805|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558806|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558807|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558808|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558809|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558810|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558811|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558812|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558813|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558814|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558815|NCT00617604|E2|Reported Event|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
558816|NCT00617604|E1|Reported Event|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
558817|NCT00617591|B1|Baseline|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
558818|NCT00617591|P1|Participant Flow|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
558819|NCT00617591|O1|Outcome|Induction at Initial Full Dose|"Induction Phase for First 29 Participants~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1."
558820|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
558821|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
558848|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558849|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily either in second intervention period
559319|NCT00616655|O1|Outcome|Placebo Arm|Placebo
558822|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
558823|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
558824|NCT00617591|E1|Reported Event|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
558825|NCT00617539|B1|Baseline|Irinotecan and Temozolomide|125 mg/m^2 irinotecan hydrochloride administered intravenously on days 1 and 15 of a 28 day cycle 100 mg/m^2 temozolomide orally for seven days on days 1-7 and days 15-21 of a 28 day cycle
558826|NCT00617539|P1|Participant Flow|Irinotecan and Temozolomide|"125 mg/m^2 irinotecan hydrochloride administered intravenously on days 1 and 15 of a 28 day cycle~100 mg/m^2 temozolomide orally for seven days on days 1-7 and days 15-21 of a 28 day cycle"
558827|NCT00617539|O1|Outcome|Irinotecan and Temozolomide|"irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle~temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle"
558828|NCT00617539|O1|Outcome|Irinotecan and Temozolomide|"irinotecan hydrochloride administered intravenously at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle~temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle"
558829|NCT00617539|O1|Outcome|Irinotecan and Temozolomide|"irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle~temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle"
558830|NCT00617539|O1|Outcome|Irinotecan and Temozolomide|"irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle~temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle"
558831|NCT00617539|O1|Outcome|Irinotecan and Temozolomide|"irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle~temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle"
558832|NCT00617539|E1|Reported Event|Irinotecan and Temozolomide|irinotecan hydrochloride administered intravenously at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle, and temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 every 28 days.
558833|NCT00617461|B1|Baseline|All Participants in the Intent-to-Treat Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment, summarized independent of treatment sequence.
558834|NCT00617461|P2|Participant Flow|GEn 3600 mg/Day Followed by GEn 1200 mg/Day|GEn 3600 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 1200 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days.
558835|NCT00617461|P1|Participant Flow|GEn 1200 mg/Day Followed by GEn 3600 mg/Day|Gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, 1200 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 3600 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 1200 mg/day for 3 days, followed by 600 mg/ day for 3 days.
558836|NCT00617461|O3|Outcome|Gabapentin 1800 mg|PK population from Gabapentin 1800 mg Baseline Treatment period
558837|NCT00617461|O2|Outcome|GEn 3600 mg|PK population from GEn 3600 mg treatment daily from either first intervention period or second intervention period
558838|NCT00617461|O1|Outcome|GEn 1200 mg|PK population from GEn 1200 mg treatment daily from either first intervention period or second intervention period
558839|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558840|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558841|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558842|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558843|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
558844|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
558845|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
558846|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
558851|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
558852|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
558853|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558854|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558855|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558856|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558857|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
558858|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
558859|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
558860|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
558861|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558862|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558863|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558864|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558865|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558866|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558867|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558868|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558869|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558870|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558871|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558872|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558873|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558874|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558875|NCT00617461|O4|Outcome|GEn 3600 mg in Second Interevention Period|GEn 3600 mg daily in second intervention period only
558876|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period only
558877|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period only
558878|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period only
558879|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558880|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558881|NCT00617461|E6|Reported Event|Overall GEn|All participants receiving GEn in any treatment period
558882|NCT00617461|E5|Reported Event|Down-Titration Period|Participants down- titrated from GEn 3600 mg/day by taking 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days before ending the assigned treatment. Participants down- titrated from GEn 1200 mg/day by taking 1200 mg/day for 3 days, followed by 600 mg/day for 3 days before ending the assigned treatment.
558883|NCT00617461|E4|Reported Event|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
558884|NCT00617461|E3|Reported Event|Crossover GEn 2400 mg|GEn 2400 mg daily during 4-day crossover period in between the first intervention period and the second intervention period
558885|NCT00617461|E2|Reported Event|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
558886|NCT00617461|E1|Reported Event|Baseline Gabapentin 1800 mg|Gabapentin 1800 mg daily for 2 weeks before randomization. Only includes participants who were subsequently randomized.
558887|NCT00617409|B4|Baseline|Total|Total of all reporting groups
558888|NCT00617409|B3|Baseline|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
558889|NCT00617409|B2|Baseline|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
558890|NCT00617409|B1|Baseline|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
558891|NCT00617409|P3|Participant Flow|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
558892|NCT00617409|P2|Participant Flow|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
558893|NCT00617409|P1|Participant Flow|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
558894|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
558895|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
558896|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
558897|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
558898|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
558899|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
558900|NCT00617409|E3|Reported Event|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
558901|NCT00617409|E2|Reported Event|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
558902|NCT00617409|E1|Reported Event|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
558903|NCT00617396|B1|Baseline|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group.
558904|NCT00617396|P1|Participant Flow|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. 25 subjects were enrolled in this group.
558905|NCT00617396|O1|Outcome|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)30 subjects were enrolled in this group.
558906|NCT00617396|E1|Reported Event|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose Quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)29 subjects were enrolled in this group.
558907|NCT00617357|B1|Baseline|One Arm|Strattice Reconstructive Tissue Matrix
558908|NCT00617357|P1|Participant Flow|Strattice Tissue Matrix|
558909|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
558910|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
558911|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
558912|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
558913|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
558914|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
558915|NCT00617357|O1|Outcome|One Arm|Strattice Reconstructive Tissue Matrix
558916|NCT00617357|E1|Reported Event|Strattice|
558917|NCT00617305|B4|Baseline|Total|Total of all reporting groups
558918|NCT00617305|B3|Baseline|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
558919|NCT00617305|B2|Baseline|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
558920|NCT00617305|B1|Baseline|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
558921|NCT00617305|P3|Participant Flow|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
558922|NCT00617305|P2|Participant Flow|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
558923|NCT00617305|P1|Participant Flow|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
558924|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558925|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558926|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558927|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558928|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558929|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558930|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558931|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558932|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558933|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558934|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558935|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558936|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558937|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558938|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558939|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558940|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558941|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558942|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558943|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558944|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558945|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558946|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558947|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558948|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558949|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558950|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558951|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558952|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558953|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558954|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558955|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558956|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558957|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558958|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558959|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558960|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
559082|NCT00617175|E1|Reported Event|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
559083|NCT00617123|B3|Baseline|Total|Total of all reporting groups
558961|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558962|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558963|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558964|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558965|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558966|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558967|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558968|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
558969|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
558970|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
558971|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
558972|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
558973|NCT00617305|E3|Reported Event|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
558974|NCT00617305|E2|Reported Event|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i
558975|NCT00617305|E1|Reported Event|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
558976|NCT00617279|B3|Baseline|Total|Total of all reporting groups
558977|NCT00617279|B2|Baseline|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558978|NCT00617279|B1|Baseline|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558979|NCT00617279|P2|Participant Flow|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558980|NCT00617279|P1|Participant Flow|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558981|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558982|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558998|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559084|NCT00617123|B2|Baseline|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
558983|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558984|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558985|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558986|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558987|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558988|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558989|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558990|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558991|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558992|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558993|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558994|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558995|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558996|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
558997|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
558999|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559000|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559001|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559002|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559003|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559004|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559005|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559006|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559007|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559008|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559009|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559010|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559011|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559012|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559013|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559014|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559015|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559016|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559017|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559018|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559019|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559020|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559021|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559022|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559023|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559024|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559025|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559026|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559027|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559028|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559079|NCT00617175|O2|Outcome|NID 30/40|Prolonged number of interval to detect ventricular arrhythmias
559080|NCT00617175|O1|Outcome|NID 18/24|standard number of interval to detect ventricular arrhythmias
559081|NCT00617175|E2|Reported Event|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
559029|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
559030|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
559031|NCT00617279|E2|Reported Event|Disadvantaged Autologous Vein Graft|Disadvantaged Autologous Vein Graft
559032|NCT00617279|E1|Reported Event|GORE PROPATEN Vascular Graft|GORE PROPATEN Vascular Graft
559033|NCT00617240|B3|Baseline|Total|Total of all reporting groups
559034|NCT00617240|B2|Baseline|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559035|NCT00617240|B1|Baseline|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559036|NCT00617240|P2|Participant Flow|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559037|NCT00617240|P1|Participant Flow|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559038|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559039|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559040|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559041|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559042|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559043|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559044|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559045|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559046|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559047|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559048|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559049|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559050|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559051|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559052|NCT00617240|E2|Reported Event|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
559053|NCT00617240|E1|Reported Event|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
559054|NCT00617201|B3|Baseline|Total|Total of all reporting groups
559055|NCT00617201|B2|Baseline|Atomoxetine|Atomoxetine (80 mg/day)
559056|NCT00617201|B1|Baseline|Placebo|Matched placebo
559057|NCT00617201|P2|Participant Flow|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
559058|NCT00617201|P1|Participant Flow|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
559059|NCT00617201|O2|Outcome|Atomoxetine|Atomoxetine (80 mg/day)
559060|NCT00617201|O1|Outcome|Placebo|Matched placebo
559061|NCT00617201|O2|Outcome|Atomoxetine|80 mg/day (after intial 4-day run up)
559062|NCT00617201|O1|Outcome|Placebo|Matched Placebo
559063|NCT00617201|E2|Reported Event|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
559064|NCT00617201|E1|Reported Event|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
559065|NCT00617188|B1|Baseline|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559066|NCT00617188|P1|Participant Flow|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559067|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559068|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559069|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559070|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559071|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559072|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559073|NCT00617188|E1|Reported Event|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
559074|NCT00617175|B3|Baseline|Total|Total of all reporting groups
559075|NCT00617175|B2|Baseline|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
559076|NCT00617175|B1|Baseline|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
559077|NCT00617175|P2|Participant Flow|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
559078|NCT00617175|P1|Participant Flow|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
559085|NCT00617123|B1|Baseline|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559086|NCT00617123|P2|Participant Flow|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
559087|NCT00617123|P1|Participant Flow|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559088|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
559089|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559090|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
559091|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559092|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
559093|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559094|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
559095|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559096|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
559097|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559098|NCT00617123|E2|Reported Event|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
559099|NCT00617123|E1|Reported Event|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
559100|NCT00617097|B3|Baseline|Total|Total of all reporting groups
559101|NCT00617097|B2|Baseline|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
559102|NCT00617097|B1|Baseline|Paracervical Block With Lidocaine|Subjects who received pain control with paracervical block with 18mL of 1% lidocaine and 2mL of saline during first trimester surgical abortion
559103|NCT00617097|P2|Participant Flow|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control of paracervical block with combined 30mg of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
559104|NCT00617097|P1|Participant Flow|Paracervical Block With Lidocaine|Subjects who received paracervical block with 18 mL of 1% lidocaine and 2 mL of saline for pain control during first trimester surgical abortion
559105|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
559106|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
559107|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
559108|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
559109|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
559110|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
559111|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
559112|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
559113|NCT00617097|E2|Reported Event|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
559114|NCT00617097|E1|Reported Event|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
559115|NCT00617084|B3|Baseline|Total|Total of all reporting groups
559116|NCT00617084|B2|Baseline|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
559117|NCT00617084|B1|Baseline|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
559118|NCT00617084|P2|Participant Flow|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
559119|NCT00617084|P1|Participant Flow|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
559120|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
559121|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
559122|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
559123|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
559124|NCT00617084|E2|Reported Event|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
559125|NCT00617084|E1|Reported Event|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
559126|NCT00617058|B4|Baseline|Total|Total of all reporting groups
559127|NCT00617058|B3|Baseline|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559168|NCT00617058|E1|Reported Event|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559169|NCT00616967|B3|Baseline|Total|Total of all reporting groups
559128|NCT00617058|B2|Baseline|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559129|NCT00617058|B1|Baseline|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559130|NCT00617058|P3|Participant Flow|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559131|NCT00617058|P2|Participant Flow|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559132|NCT00617058|P1|Participant Flow|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559133|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559134|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559135|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559136|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559137|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559138|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559139|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559140|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559141|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559142|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559143|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559144|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559145|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559146|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559147|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559233|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559148|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559149|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559150|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559151|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559152|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559153|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559154|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559155|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559156|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559157|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559158|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559159|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559160|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559161|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559162|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559163|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559164|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559165|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
559166|NCT00617058|E3|Reported Event|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
559167|NCT00617058|E2|Reported Event|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
559261|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559170|NCT00616967|B2|Baseline|Vorinostat (Arm 2)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
559171|NCT00616967|B1|Baseline|Placebo (Arm 1)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
559172|NCT00616967|P3|Participant Flow|Vorinostat (Arm II)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
559173|NCT00616967|P2|Participant Flow|Placebo (Arm I)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
559174|NCT00616967|P1|Participant Flow|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
559175|NCT00616967|O2|Outcome|Non-Responders|Pooled data from participants who did not receive a pathologic complete response across arms.
559176|NCT00616967|O1|Outcome|Responders|Pooled data from participants who received a pathologic complete response across arms.
559177|NCT00616967|O2|Outcome|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
559178|NCT00616967|O1|Outcome|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
559179|NCT00616967|E3|Reported Event|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
559180|NCT00616967|E2|Reported Event|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
559181|NCT00616967|E1|Reported Event|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally~Events summarized in this arm are those that met 5% reporting threshold in Arms I and II."
559182|NCT00616928|B5|Baseline|Total|Total of all reporting groups
559183|NCT00616928|B4|Baseline|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559184|NCT00616928|B3|Baseline|Influenza A (H5N1) >64Y Group|Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559185|NCT00616928|B2|Baseline|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559186|NCT00616928|B1|Baseline|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559187|NCT00616928|P4|Participant Flow|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559188|NCT00616928|P3|Participant Flow|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559189|NCT00616928|P2|Participant Flow|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559190|NCT00616928|P1|Participant Flow|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559191|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559192|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559193|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559194|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559195|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559196|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559197|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559198|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559199|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged >64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559200|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559201|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559202|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559203|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559204|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559205|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559206|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559207|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559208|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559209|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559210|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559211|NCT00616928|O4|Outcome|Placebo >60Y Group|Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559212|NCT00616928|O3|Outcome|Influenza A (H5N1) >60Y Group|Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559213|NCT00616928|O2|Outcome|Placebo 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559214|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559215|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559216|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559217|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559218|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559219|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559220|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559221|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559222|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559223|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559224|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559225|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559226|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559227|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559228|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559229|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559230|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559231|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559232|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559262|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559234|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559235|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559236|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559237|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559238|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
559239|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559240|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559241|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559242|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
559243|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559244|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559245|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559246|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559247|NCT00616928|E4|Reported Event|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559248|NCT00616928|E3|Reported Event|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559249|NCT00616928|E2|Reported Event|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559250|NCT00616928|E1|Reported Event|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
559251|NCT00616902|B3|Baseline|Total|Total of all reporting groups
559252|NCT00616902|B2|Baseline|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559253|NCT00616902|B1|Baseline|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559254|NCT00616902|P2|Participant Flow|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559255|NCT00616902|P1|Participant Flow|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559256|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559257|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559258|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559259|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559260|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559263|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559264|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559265|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559266|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559267|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559268|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559269|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559270|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559271|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559272|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559273|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559274|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559275|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559276|NCT00616902|E2|Reported Event|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559277|NCT00616902|E1|Reported Event|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
559278|NCT00616772|B3|Baseline|Total|Total of all reporting groups
559279|NCT00616772|B2|Baseline|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559280|NCT00616772|B1|Baseline|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559281|NCT00616772|P2|Participant Flow|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559282|NCT00616772|P1|Participant Flow|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559283|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559284|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559285|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559286|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559287|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559288|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559289|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559290|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559291|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559292|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559293|NCT00616772|E2|Reported Event|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
559294|NCT00616772|E1|Reported Event|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
559295|NCT00616759|B3|Baseline|Total|Total of all reporting groups
559296|NCT00616759|B2|Baseline|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
559297|NCT00616759|B1|Baseline|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
559298|NCT00616759|P2|Participant Flow|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
559299|NCT00616759|P1|Participant Flow|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
559300|NCT00616759|O2|Outcome|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
559301|NCT00616759|O1|Outcome|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
559302|NCT00616759|E2|Reported Event|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
559303|NCT00616759|E1|Reported Event|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
559304|NCT00616655|B4|Baseline|Total|Total of all reporting groups
559305|NCT00616655|B3|Baseline|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559306|NCT00616655|B2|Baseline|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559307|NCT00616655|B1|Baseline|Placebo Arm|Placebo
559308|NCT00616655|P3|Participant Flow|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559309|NCT00616655|P2|Participant Flow|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559310|NCT00616655|P1|Participant Flow|Placebo Arm|Placebo
559311|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559312|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559313|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559314|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559315|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559316|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559317|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559320|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559321|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559322|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559323|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559324|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559325|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559326|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559327|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559328|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559329|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559330|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559331|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559332|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559333|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559334|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559335|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559336|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559337|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559338|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559339|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559340|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559341|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559342|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559343|NCT00616655|O1|Outcome|Placebo Arm|Placebo
559344|NCT00616655|E3|Reported Event|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
559345|NCT00616655|E2|Reported Event|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
559346|NCT00616655|E1|Reported Event|Placebo Arm|Placebo
559347|NCT00616642|B3|Baseline|Total|Total of all reporting groups
559348|NCT00616642|B2|Baseline|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559349|NCT00616642|B1|Baseline|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559350|NCT00616642|P2|Participant Flow|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559351|NCT00616642|P1|Participant Flow|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559352|NCT00616642|O2|Outcome|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559353|NCT00616642|O1|Outcome|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559354|NCT00616642|E2|Reported Event|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559355|NCT00616642|E1|Reported Event|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
559356|NCT00616629|B6|Baseline|Total|Total of all reporting groups
559357|NCT00616629|B5|Baseline|Placebo|Corresponding placebo
559358|NCT00616629|B4|Baseline|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559359|NCT00616629|B3|Baseline|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559360|NCT00616629|B2|Baseline|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559361|NCT00616629|B1|Baseline|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559362|NCT00616629|P5|Participant Flow|Placebo|Corresponding placebo
559363|NCT00616629|P4|Participant Flow|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559364|NCT00616629|P3|Participant Flow|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559365|NCT00616629|P2|Participant Flow|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559366|NCT00616629|P1|Participant Flow|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559367|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
559368|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559707|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559369|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559370|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559371|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559372|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
559373|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559374|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559375|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559376|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559377|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
559378|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559379|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559380|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559381|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559382|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
559383|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559384|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559385|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559386|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559387|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
559388|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559389|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559390|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559391|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559392|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
559393|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559394|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559395|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559396|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559397|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
559398|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559399|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559400|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559401|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559402|NCT00616629|E5|Reported Event|Placebo|Corresponding placebo
559403|NCT00616629|E4|Reported Event|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
559404|NCT00616629|E3|Reported Event|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
559405|NCT00616629|E2|Reported Event|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
559406|NCT00616629|E1|Reported Event|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
559407|NCT00616603|B4|Baseline|Total|Total of all reporting groups
559408|NCT00616603|B3|Baseline|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
559409|NCT00616603|B2|Baseline|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
559410|NCT00616603|B1|Baseline|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
559411|NCT00616603|P3|Participant Flow|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
559412|NCT00616603|P2|Participant Flow|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
559413|NCT00616603|P1|Participant Flow|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
559414|NCT00616603|O3|Outcome|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
559415|NCT00616603|O2|Outcome|Group B|Subjects in Group B will have 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml of normal saline
559416|NCT00616603|O1|Outcome|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal sali
559417|NCT00616603|E3|Reported Event|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
559708|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559418|NCT00616603|E2|Reported Event|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
559419|NCT00616603|E1|Reported Event|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
559420|NCT00616577|B4|Baseline|Total|Total of all reporting groups
559421|NCT00616577|B3|Baseline|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
559422|NCT00616577|B2|Baseline|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559423|NCT00616577|B1|Baseline|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559424|NCT00616577|P3|Participant Flow|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
559425|NCT00616577|P2|Participant Flow|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559426|NCT00616577|P1|Participant Flow|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559427|NCT00616577|O3|Outcome|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
559428|NCT00616577|O2|Outcome|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559429|NCT00616577|O1|Outcome|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559430|NCT00616577|E3|Reported Event|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
559431|NCT00616577|E2|Reported Event|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559432|NCT00616577|E1|Reported Event|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
559433|NCT00616434|B3|Baseline|Total|Total of all reporting groups
559434|NCT00616434|B2|Baseline|Placebo|Placebo IM injection twice weekly for 12 weeks
559435|NCT00616434|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
559436|NCT00616434|P2|Participant Flow|Placebo|Placebo IM injection twice weekly for 12 weeks
559437|NCT00616434|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
559438|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
559439|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
559440|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
559441|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
559442|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
559443|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
559444|NCT00616434|E2|Reported Event|Placebo|Placebo IM injection twice weekly for 12 weeks
559445|NCT00616434|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
559446|NCT00616421|B4|Baseline|Total|Total of all reporting groups
559447|NCT00616421|B3|Baseline|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1.
559448|NCT00616421|B2|Baseline|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1.
559449|NCT00616421|B1|Baseline|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age.
559450|NCT00616421|P3|Participant Flow|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
559451|NCT00616421|P2|Participant Flow|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
559452|NCT00616421|P1|Participant Flow|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
559453|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
559454|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
559455|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 6 to 10 years of age.
559456|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 6 to 10 years of age.
559457|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 2 to 5 years of age.
559458|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 2 to 5 years of age.
559459|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
559460|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
559461|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
559462|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
559463|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
559464|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
559465|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 6 to 10 years of age
559466|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
559467|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age
559468|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
559469|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
559470|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
559471|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age.
559472|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
559473|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
559474|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
559475|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
559476|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
559477|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
559478|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
559479|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
559480|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
559481|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
559482|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
559483|NCT00616421|E5|Reported Event|Licensed Polysaccharide Vaccine_6 to 10 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.
559484|NCT00616421|E4|Reported Event|Licensed Polysaccharide Vaccine_2 to 5 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.
559485|NCT00616421|E3|Reported Event|MenACWY-CRM (1 Dose)_6 to 10 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.
559486|NCT00616421|E2|Reported Event|MenACWY-CRM (1 Dose)_2 to 5 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.
559487|NCT00616421|E1|Reported Event|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
559488|NCT00616343|B1|Baseline|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
559489|NCT00616343|P1|Participant Flow|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
559490|NCT00616343|O1|Outcome|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
559491|NCT00616343|E1|Reported Event|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
559492|NCT00616239|B1|Baseline|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
559493|NCT00616239|P1|Participant Flow|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
559494|NCT00616239|O1|Outcome|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
559495|NCT00616239|E1|Reported Event|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
559496|NCT00616200|B1|Baseline|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
559497|NCT00616200|P1|Participant Flow|Standard Diet Then Very Low Carbohydrate Diet|Two weeks of a carbohydrate rich diet was followed by four weeks of A Very Low Carbohydrate Diet. VLCD = <20g/day of carbohydrates
559498|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
559499|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
559500|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
559501|NCT00616200|E1|Reported Event|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
559502|NCT00616122|B1|Baseline|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
559503|NCT00616122|P1|Participant Flow|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
559504|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
559505|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
559506|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
559507|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
559508|NCT00616122|E1|Reported Event|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
559509|NCT00616109|B1|Baseline|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
559510|NCT00616109|P1|Participant Flow|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
559511|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
559578|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559512|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
559513|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
559514|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
559515|NCT00616109|E1|Reported Event|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
559516|NCT00616018|B1|Baseline|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
559517|NCT00616018|P1|Participant Flow|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
559518|NCT00616018|O1|Outcome|Acetaminophen|acetaminophen treatment group
559519|NCT00616018|O1|Outcome|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
559520|NCT00616018|E1|Reported Event|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
559521|NCT00615992|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559522|NCT00615992|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559523|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559524|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559525|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559526|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559527|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559528|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559529|NCT00615992|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
559530|NCT00615927|B3|Baseline|Total|Total of all reporting groups
559531|NCT00615927|B2|Baseline|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559532|NCT00615927|B1|Baseline|Astrocytoma|Grade II Astrocytoma
559533|NCT00615927|P2|Participant Flow|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559534|NCT00615927|P1|Participant Flow|Astrocytoma|Grade II Astrocytoma
559535|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559536|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
559537|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559538|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
559539|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559540|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
559541|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559542|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
559543|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559544|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
559545|NCT00615927|E2|Reported Event|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
559546|NCT00615927|E1|Reported Event|Astrocytoma|Grade II Astrocytoma
559547|NCT00615914|B1|Baseline|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
559548|NCT00615914|P1|Participant Flow|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
559549|NCT00615914|O1|Outcome|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
559550|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
559551|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
559552|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
559553|NCT00615914|E1|Reported Event|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg) was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
559554|NCT00615901|B1|Baseline|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
559555|NCT00615901|P1|Participant Flow|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
559556|NCT00615901|O1|Outcome|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
559557|NCT00615901|E1|Reported Event|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
559558|NCT00615836|B5|Baseline|Total|Total of all reporting groups
559559|NCT00615836|B4|Baseline|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559560|NCT00615836|B3|Baseline|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559561|NCT00615836|B2|Baseline|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559562|NCT00615836|B1|Baseline|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559563|NCT00615836|P5|Participant Flow|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
559564|NCT00615836|P4|Participant Flow|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
559565|NCT00615836|P3|Participant Flow|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
559566|NCT00615836|P2|Participant Flow|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
559567|NCT00615836|P1|Participant Flow|Desmopressin Melt 10 μg|"Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.~During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg)."
559568|NCT00615836|O5|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
559569|NCT00615836|O4|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
559570|NCT00615836|O3|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
559571|NCT00615836|O2|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559572|NCT00615836|O1|Outcome|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt.
559573|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559574|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559575|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559576|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559577|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559709|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559579|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559580|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559581|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559582|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559583|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559584|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559585|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559586|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559587|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559588|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559589|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559590|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559591|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559592|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559593|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559594|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559595|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559596|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559597|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559598|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559599|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559600|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559601|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559602|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559603|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559604|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559605|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559606|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559607|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559608|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559609|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559610|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559611|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559612|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559613|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559614|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559615|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559616|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559617|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559618|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559619|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
559620|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559621|NCT00615836|E5|Reported Event|Desmopressin Melt 100 μg|Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
559622|NCT00615836|E4|Reported Event|Desmopressin Melt 50 μg|Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
559623|NCT00615836|E3|Reported Event|Desmopressin Melt 25 μg|Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
559624|NCT00615836|E2|Reported Event|Desmopressin Melt 10 μg|Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
559625|NCT00615836|E1|Reported Event|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt.
559626|NCT00615719|B1|Baseline|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
559627|NCT00615719|P1|Participant Flow|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
559628|NCT00615719|O1|Outcome|Computed Tomographic Coronary Angiography for Chest Pain Evalu|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA)
559629|NCT00615719|E1|Reported Event|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
559630|NCT00615589|B1|Baseline|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559631|NCT00615589|P1|Participant Flow|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559632|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559633|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559634|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559710|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559711|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559712|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559635|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559636|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559637|NCT00615589|E1|Reported Event|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
559638|NCT00615550|B3|Baseline|Total|Total of all reporting groups
559639|NCT00615550|B2|Baseline|Prochieve|Progesterone 8% Vaginal Gel
559640|NCT00615550|B1|Baseline|Placebo|placebo vaginal gel
559641|NCT00615550|P2|Participant Flow|Prochieve|Progesterone 8% Vaginal Gel
559642|NCT00615550|P1|Participant Flow|Placebo|placebo vaginal gel
559643|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
559644|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
559645|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
559646|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
559647|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
559648|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
559649|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
559650|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
559651|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
559652|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
559653|NCT00615550|E2|Reported Event|Prochieve|Progesterone 8% Vaginal Gel
559654|NCT00615550|E1|Reported Event|Placebo|placebo vaginal gel
559655|NCT00615472|B3|Baseline|Total|Total of all reporting groups
559656|NCT00615472|B2|Baseline|Intravenous Anesthesia|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed"
559657|NCT00615472|B1|Baseline|Inhaled Anesthesia|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
559658|NCT00615472|P2|Participant Flow|Intravenous Anesthesia|Intravenous Anesthesia - propofol, remifentanil
559659|NCT00615472|P1|Participant Flow|Inhaled Anesthesia|Inhaled Anesthesia - isoflurane
559660|NCT00615472|O2|Outcome|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
559661|NCT00615472|O1|Outcome|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
559662|NCT00615472|E2|Reported Event|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
559663|NCT00615472|E1|Reported Event|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
559664|NCT00615459|B1|Baseline|Total Patients|The safety population, included all patients who received at least one dose of study drug.
559665|NCT00615459|P4|Participant Flow|Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg|In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
559683|NCT00615433|B3|Baseline|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
559666|NCT00615459|P3|Participant Flow|Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo|In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
559667|NCT00615459|P2|Participant Flow|Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium|In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
559668|NCT00615459|P1|Participant Flow|Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg|In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559669|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559670|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559671|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559672|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559673|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559674|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559675|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559676|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559677|NCT00615459|E4|Reported Event|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
559678|NCT00615459|E3|Reported Event|Tiotropium 18 μg|Tiotropium 18 μg once daily delivered via inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
559679|NCT00615459|E2|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
559680|NCT00615459|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via single dose dry powder inhaler (SDDPI) and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559681|NCT00615433|B5|Baseline|Total|Total of all reporting groups
559682|NCT00615433|B4|Baseline|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
559684|NCT00615433|B2|Baseline|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
559685|NCT00615433|B1|Baseline|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
559686|NCT00615433|P4|Participant Flow|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
559687|NCT00615433|P3|Participant Flow|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
559688|NCT00615433|P2|Participant Flow|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
559689|NCT00615433|P1|Participant Flow|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
559690|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
559691|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
559692|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
559693|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
559694|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
559695|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
559696|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day.
559697|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
559698|NCT00615433|E4|Reported Event|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
559699|NCT00615433|E3|Reported Event|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
559700|NCT00615433|E2|Reported Event|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
559701|NCT00615433|E1|Reported Event|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
559702|NCT00615290|B1|Baseline|Aptivus|Patients treated by Aptivus in daily practice
559703|NCT00615290|P1|Participant Flow|Aptivus|Patients treated by Aptivus in daily practice
559704|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559705|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559706|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
559713|NCT00615290|E1|Reported Event|Aptivus|Patients treated by Aptivus in daily practice
559714|NCT00615264|B3|Baseline|Total|Total of all reporting groups
559715|NCT00615264|B2|Baseline|Placebo|"Mannitol 40 mg in 0.5 mL Lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
559716|NCT00615264|B1|Baseline|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5mL Lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
559717|NCT00615264|P2|Participant Flow|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
559718|NCT00615264|P1|Participant Flow|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
559719|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
559720|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
559721|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
559722|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
559723|NCT00615264|E2|Reported Event|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
559724|NCT00615264|E1|Reported Event|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
559725|NCT00615199|B5|Baseline|Total|Total of all reporting groups
559726|NCT00615199|B4|Baseline|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559727|NCT00615199|B3|Baseline|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559728|NCT00615199|B2|Baseline|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559729|NCT00615199|B1|Baseline|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559730|NCT00615199|P4|Participant Flow|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559731|NCT00615199|P3|Participant Flow|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559732|NCT00615199|P2|Participant Flow|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559733|NCT00615199|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559734|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559735|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559736|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559737|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559738|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559739|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559740|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559741|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559742|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559743|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559744|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559745|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559746|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559747|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559748|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559749|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559750|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559751|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559752|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559753|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559754|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559755|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559756|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559757|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559758|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559759|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559760|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559761|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559762|NCT00615199|E4|Reported Event|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
559763|NCT00615199|E3|Reported Event|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
559764|NCT00615199|E2|Reported Event|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
559765|NCT00615199|E1|Reported Event|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
559766|NCT00615108|B1|Baseline|Hypertension Patients|Telmisartan 40mg or 80 mg
559767|NCT00615108|P1|Participant Flow|Hypertension Patients|Telmisartan 40mg or 80 mg
559768|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
559769|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
559770|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
559771|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
559772|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
559773|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
559774|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
559775|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
559776|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
559777|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
559778|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
559779|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
559780|NCT00615108|E1|Reported Event|Hypertension Patients|Telmisartan 40mg or 80 mg
559781|NCT00615069|B1|Baseline|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment.
559782|NCT00615069|P1|Participant Flow|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. Participant Flow results reflect the final (5 year) data.
559783|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
559784|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
559785|NCT00615069|E1|Reported Event|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA).
559786|NCT00615056|B5|Baseline|Total|Total of all reporting groups
559787|NCT00615056|B4|Baseline|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559788|NCT00615056|B3|Baseline|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559789|NCT00615056|B2|Baseline|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559790|NCT00615056|B1|Baseline|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559791|NCT00615056|P4|Participant Flow|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559792|NCT00615056|P3|Participant Flow|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559793|NCT00615056|P2|Participant Flow|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559794|NCT00615056|P1|Participant Flow|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559795|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559899|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559900|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559796|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559797|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559798|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559799|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559800|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559801|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559802|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559803|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559804|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559805|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559806|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559807|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559808|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559809|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559810|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559901|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559902|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559903|NCT00615017|O6|Outcome|Placebo|Placebo
559811|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559812|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559813|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559814|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559815|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559816|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559817|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559818|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559819|NCT00615056|E4|Reported Event|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559820|NCT00615056|E3|Reported Event|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559821|NCT00615056|E2|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559822|NCT00615056|E1|Reported Event|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
559823|NCT00615030|B1|Baseline|Total Patients|
559824|NCT00615030|P12|Participant Flow|Sequence 12: Placebo, Indacaterol Evening, Indacaterol Morning|In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559846|NCT00615030|E2|Reported Event|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
559904|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559825|NCT00615030|P11|Participant Flow|Sequence 11:Salmeterol,Indacaterol Morning,Indacaterol Evening|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559826|NCT00615030|P10|Participant Flow|Sequence 10: Indacaterol Evening, Placebo, Salmeterol|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559827|NCT00615030|P9|Participant Flow|Sequence 9:Indacaterol Morning, Salmeterol, Placebo|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559828|NCT00615030|P8|Participant Flow|Sequence 8: Placebo, Indacaterol Morning, Salmeterol|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559829|NCT00615030|P7|Participant Flow|Sequence 7: Salmeterol, Indacaterol Evening, Placebo|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559830|NCT00615030|P6|Participant Flow|Sequence 6:Indacaterol Evening,Salmeterol, Indacaterol Morning|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559831|NCT00615030|P5|Participant Flow|Sequence 5: Indacaterol Morning, Placebo, Indacaterol Evening|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559832|NCT00615030|P4|Participant Flow|Sequence 4: Placebo, Salmeterol, Indacaterol Evening|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559833|NCT00615030|P3|Participant Flow|Sequence 3: Salmeterol, Placebo, Indacaterol Morning|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559834|NCT00615030|P2|Participant Flow|Sequence 2:Indacaterol Evening,Indacaterol Morning, Placebo|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559835|NCT00615030|P1|Participant Flow|Sequence 1:Indacaterol Morning,Indacaterol Evening, Salmeterol|In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559836|NCT00615030|O6|Outcome|Placebo Evening|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559837|NCT00615030|O5|Outcome|Placebo Morning|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559838|NCT00615030|O4|Outcome|Salmeterol Evening|In the evening, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559839|NCT00615030|O3|Outcome|Salmeterol Morning|In the morning, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559840|NCT00615030|O2|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559841|NCT00615030|O1|Outcome|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559842|NCT00615030|O2|Outcome|Placebo|During evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559843|NCT00615030|O1|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via single dose dry powder inhaler (SDDPI) and placebo to salmeterol delivered via dry powder inhaler (DPI). Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
559844|NCT00615030|E4|Reported Event|Placebo|During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
559845|NCT00615030|E3|Reported Event|Salmeterol|Salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning along with placebo matching indacaterol delivered by single dose dry powder inhaler (SDDPI). The second dose of salmeterol was administered in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
559898|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559847|NCT00615030|E1|Reported Event|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
559848|NCT00615017|B7|Baseline|Total|Total of all reporting groups
559849|NCT00615017|B6|Baseline|Placebo|Placebo
559850|NCT00615017|B5|Baseline|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559851|NCT00615017|B4|Baseline|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559852|NCT00615017|B3|Baseline|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559853|NCT00615017|B2|Baseline|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559854|NCT00615017|B1|Baseline|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559855|NCT00615017|P6|Participant Flow|Placebo|Placebo
559856|NCT00615017|P5|Participant Flow|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559857|NCT00615017|P4|Participant Flow|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559858|NCT00615017|P3|Participant Flow|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559859|NCT00615017|P2|Participant Flow|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559860|NCT00615017|P1|Participant Flow|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559861|NCT00615017|O6|Outcome|Placebo|Placebo
559862|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559863|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559864|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559865|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559866|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559867|NCT00615017|O6|Outcome|Placebo|Placebo
559868|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559869|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559870|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559871|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559872|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559873|NCT00615017|O6|Outcome|Placebo|Placebo
559874|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559875|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559876|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559877|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559878|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559879|NCT00615017|O6|Outcome|Placebo|Placebo
559880|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559881|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559882|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559883|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559884|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559885|NCT00615017|O6|Outcome|Placebo|Placebo
559886|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559887|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559888|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559889|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559890|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559891|NCT00615017|O6|Outcome|Placebo|Placebo
559892|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559893|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559894|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559895|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559896|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559897|NCT00615017|O6|Outcome|Placebo|Placebo
560323|NCT00614406|B2|Baseline|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
559905|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559906|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559907|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559908|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559909|NCT00615017|O6|Outcome|Placebo|Placebo
559910|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559911|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559912|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559913|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559914|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559915|NCT00615017|O6|Outcome|Placebo|Placebo
559916|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559917|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559918|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559919|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559920|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559921|NCT00615017|O6|Outcome|Placebo|Placebo
559922|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559923|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559924|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559925|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559926|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559927|NCT00615017|O6|Outcome|Placebo|Placebo
559928|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559929|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559930|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559931|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559932|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559933|NCT00615017|O6|Outcome|Placebo|Placebo
559934|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559935|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559936|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559937|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559938|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559939|NCT00615017|O6|Outcome|Placebo|Placebo
559940|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559941|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559942|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559943|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559944|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559945|NCT00615017|O6|Outcome|Placebo|Placebo
559946|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559947|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559948|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559949|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559950|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559951|NCT00615017|O6|Outcome|Placebo|Placebo
559952|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559953|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559954|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559955|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559956|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559957|NCT00615017|O6|Outcome|Placebo|Placebo
559958|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559959|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559960|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559961|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559962|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559963|NCT00615017|O6|Outcome|Placebo|Placebo
559964|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559965|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559966|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559967|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559968|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559969|NCT00615017|O6|Outcome|Placebo|Placebo
559970|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559971|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559972|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559973|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559974|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559975|NCT00615017|O6|Outcome|Placebo|Placebo
559976|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559977|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559978|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559979|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559980|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559981|NCT00615017|O6|Outcome|Placebo|Placebo
559982|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559983|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559984|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559985|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559986|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559987|NCT00615017|O6|Outcome|Placebo|Placebo
559988|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559989|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559990|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559991|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559992|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559993|NCT00615017|O6|Outcome|Placebo|Placebo
559994|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
559995|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
559996|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
559997|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
559998|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
559999|NCT00615017|O6|Outcome|Placebo|Placebo
560000|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
560001|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
560002|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
560003|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
560004|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
560005|NCT00615017|E6|Reported Event|Placebo|Placebo
560006|NCT00615017|E5|Reported Event|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
560007|NCT00615017|E4|Reported Event|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
560008|NCT00615017|E3|Reported Event|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
560009|NCT00615017|E2|Reported Event|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
560010|NCT00615017|E1|Reported Event|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
560011|NCT00614991|B7|Baseline|Total|Total of all reporting groups
560012|NCT00614991|B6|Baseline|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
560013|NCT00614991|B5|Baseline|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
560014|NCT00614991|B4|Baseline|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
560015|NCT00614991|B3|Baseline|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
560016|NCT00614991|B2|Baseline|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
560017|NCT00614991|B1|Baseline|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
560018|NCT00614991|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
560019|NCT00614991|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
560020|NCT00614991|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
560021|NCT00614991|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
560022|NCT00614991|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
560023|NCT00614991|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
560024|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
560025|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
560026|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
560027|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
560028|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
560029|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
560030|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
560031|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID"
560032|NCT00614991|O1|Outcome|Group A & B|Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Group B Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
560033|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
560034|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
560035|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
560036|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
560037|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
560417|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560038|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
560039|NCT00614991|O6|Outcome|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
560040|NCT00614991|O5|Outcome|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
560041|NCT00614991|O4|Outcome|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
560042|NCT00614991|O3|Outcome|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
560043|NCT00614991|O2|Outcome|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
560044|NCT00614991|O1|Outcome|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
560045|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
560046|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
560047|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
560048|NCT00614991|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
560049|NCT00614991|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
560050|NCT00614991|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
560051|NCT00614991|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
560052|NCT00614991|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
560053|NCT00614991|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
560054|NCT00614939|B3|Baseline|Total|Total of all reporting groups
560055|NCT00614939|B2|Baseline|Saxa|Saxagliptin 2.5 mg once daily oral dose
560056|NCT00614939|B1|Baseline|Placebo|Placebo
560057|NCT00614939|P2|Participant Flow|Saxa|Saxagliptin 2.5 mg once daily oral dose
560058|NCT00614939|P1|Participant Flow|Placebo|Placebo
560059|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560060|NCT00614939|O1|Outcome|Placebo|Placebo
560061|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560062|NCT00614939|O1|Outcome|Placebo|Placebo
560063|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560064|NCT00614939|O1|Outcome|Placebo|Placebo
560065|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560066|NCT00614939|O1|Outcome|Placebo|Placebo
560067|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560068|NCT00614939|O1|Outcome|Placebo|Placebo
560069|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560070|NCT00614939|O1|Outcome|Placebo|Placebo
560071|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560072|NCT00614939|O1|Outcome|Placebo|Placebo
560073|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560074|NCT00614939|O1|Outcome|Placebo|Placebo
560075|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560076|NCT00614939|O1|Outcome|Placebo|Placebo
560077|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560078|NCT00614939|O1|Outcome|Placebo|Placebo
560079|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560080|NCT00614939|O1|Outcome|Placebo|Placebo
560081|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560082|NCT00614939|O1|Outcome|Placebo|Placebo
560083|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560084|NCT00614939|O1|Outcome|Placebo|Placebo
560085|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
560086|NCT00614939|O1|Outcome|Placebo|Placebo
560087|NCT00614939|E2|Reported Event|Saxa|Saxagliptin 2.5 mg once daily oral dose
560088|NCT00614939|E1|Reported Event|Placebo|Placebo
560089|NCT00614926|B3|Baseline|Total|Total of all reporting groups
560090|NCT00614926|B2|Baseline|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
560091|NCT00614926|B1|Baseline|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
560092|NCT00614926|P2|Participant Flow|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
560093|NCT00614926|P1|Participant Flow|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
560094|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
560095|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
560096|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
560097|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
560098|NCT00614926|E2|Reported Event|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
560099|NCT00614926|E1|Reported Event|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
560100|NCT00614913|B1|Baseline|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
560101|NCT00614913|P1|Participant Flow|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
560102|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
560103|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
560104|NCT00614913|E1|Reported Event|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
560105|NCT00614874|B1|Baseline|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
560106|NCT00614874|P1|Participant Flow|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
560107|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
560108|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
560109|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
560110|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
560111|NCT00614874|E1|Reported Event|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
560112|NCT00614744|B3|Baseline|Total|Total of all reporting groups
560113|NCT00614744|B2|Baseline|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560114|NCT00614744|B1|Baseline|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560115|NCT00614744|P2|Participant Flow|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560116|NCT00614744|P1|Participant Flow|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560117|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560118|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560119|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560120|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560121|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560122|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560123|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560124|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560125|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560126|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560127|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560128|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560129|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560130|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560131|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560132|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560133|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560134|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560135|NCT00614744|O2|Outcome|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560136|NCT00614744|O1|Outcome|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560137|NCT00614744|E2|Reported Event|Normothermia|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
560138|NCT00614744|E1|Reported Event|Whole-body Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
560139|NCT00614614|B3|Baseline|Total|Total of all reporting groups
560140|NCT00614614|B2|Baseline|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560141|NCT00614614|B1|Baseline|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
560142|NCT00614614|P5|Participant Flow|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560143|NCT00614614|P4|Participant Flow|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560144|NCT00614614|P3|Participant Flow|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560145|NCT00614614|P2|Participant Flow|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560146|NCT00614614|P1|Participant Flow|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group].
560147|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560148|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560149|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560150|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560151|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560152|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560153|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560154|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560155|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560156|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560157|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560158|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560159|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560160|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560161|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560162|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560163|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560164|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560165|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560418|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560166|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560167|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560168|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
560169|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
560170|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
560171|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560172|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560173|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560174|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
560175|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560176|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560177|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560178|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
560179|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560180|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560181|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560182|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560183|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560184|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560185|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560186|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560187|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560188|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560189|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560190|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560191|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560192|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560193|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560194|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560195|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560196|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560197|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560198|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560199|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560200|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560201|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560202|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560203|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560204|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560205|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560206|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560207|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560208|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560209|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560210|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560211|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560212|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560213|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560214|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560215|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560216|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560217|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560218|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560219|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560220|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560221|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560222|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560223|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560224|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560225|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560226|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560227|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560228|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560229|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560230|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560231|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560232|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560233|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560234|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560235|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560236|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560237|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560238|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560239|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560240|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560241|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560242|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560243|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560244|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560245|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560246|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560247|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560248|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560249|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560250|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560251|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560252|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560253|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560254|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560255|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560256|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560257|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560258|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560259|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560260|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560261|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560262|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560263|NCT00614614|E5|Reported Event|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560264|NCT00614614|E4|Reported Event|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560265|NCT00614614|E3|Reported Event|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
560266|NCT00614614|E2|Reported Event|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
560267|NCT00614614|E1|Reported Event|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
560268|NCT00614575|B1|Baseline|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560269|NCT00614575|P1|Participant Flow|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560270|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560271|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560272|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560273|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560293|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560419|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560274|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560275|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560276|NCT00614575|E1|Reported Event|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
560277|NCT00614523|B3|Baseline|Total|Total of all reporting groups
560278|NCT00614523|B2|Baseline|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560279|NCT00614523|B1|Baseline|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560280|NCT00614523|P2|Participant Flow|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560281|NCT00614523|P1|Participant Flow|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560282|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560283|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560284|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560285|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560286|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560287|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560288|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560289|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560290|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560291|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560292|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560294|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560295|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560296|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560297|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560298|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560299|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560300|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560301|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560302|NCT00614523|E2|Reported Event|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
560303|NCT00614523|E1|Reported Event|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
560304|NCT00614484|B1|Baseline|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
560305|NCT00614484|P1|Participant Flow|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
560306|NCT00614484|O1|Outcome|Chemotherapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
560307|NCT00614484|O1|Outcome|Chemothrapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
560308|NCT00614484|E1|Reported Event|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
560309|NCT00614458|B1|Baseline|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
560310|NCT00614458|P1|Participant Flow|Effect on Latent HIV of Adding Raltegravir and VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and Valproic acid (VPA) and current antiretroviral therapy (ART) on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
560311|NCT00614458|O1|Outcome|Effect on Latent HIV of Adding Raltegravir and VPA to ART|
560312|NCT00614458|E1|Reported Event|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
560313|NCT00614445|B3|Baseline|Total|Total of all reporting groups
560314|NCT00614445|B2|Baseline|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
560315|NCT00614445|B1|Baseline|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
560316|NCT00614445|P2|Participant Flow|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
560317|NCT00614445|P1|Participant Flow|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
560318|NCT00614445|O2|Outcome|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
560319|NCT00614445|O1|Outcome|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
560320|NCT00614445|E2|Reported Event|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
560321|NCT00614445|E1|Reported Event|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
560324|NCT00614406|B1|Baseline|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
560325|NCT00614406|P2|Participant Flow|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
560326|NCT00614406|P1|Participant Flow|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
560327|NCT00614406|O2|Outcome|Placebo|Placebo cycle orally, daily x1 menstrual cycle [cycle = length of menstrual cycle]
560328|NCT00614406|O1|Outcome|Active Drug|Active drug(celecoxib 400 mg orally, daily for 1 menstrual cycle) cycle [cycle = length of menstrual cycle]
560329|NCT00614406|E2|Reported Event|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
560330|NCT00614406|E1|Reported Event|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
560331|NCT00614393|B6|Baseline|Total|Total of all reporting groups
560332|NCT00614393|B5|Baseline|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560333|NCT00614393|B4|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560334|NCT00614393|B3|Baseline|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560335|NCT00614393|B2|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560336|NCT00614393|B1|Baseline|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560337|NCT00614393|P5|Participant Flow|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received a cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560338|NCT00614393|P4|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560339|NCT00614393|P3|Participant Flow|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560340|NCT00614393|P2|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the open-label (OL) portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV one time every two weeks (Q2W) for up to 32 months of treatment.
560341|NCT00614393|P1|Participant Flow|Dalotuzumab 10 mg/kg Q1W (DB)|In double-blind (DB) Week 1, participants received cetuximab 400 mg/m^2 intravenously (IV) loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV one time each week (Q1W) maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560342|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560343|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560420|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560421|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560422|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560423|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560344|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560345|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560346|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560347|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560348|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560349|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560350|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560351|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560352|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560353|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560354|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560355|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560356|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560357|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560358|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560424|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560359|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560360|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560361|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560362|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560363|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560364|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560365|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560366|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560367|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560368|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560369|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560370|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560371|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560372|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560373|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560425|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560374|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560375|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560376|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560377|NCT00614393|E5|Reported Event|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
560378|NCT00614393|E4|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560379|NCT00614393|E3|Reported Event|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560380|NCT00614393|E2|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
560381|NCT00614393|E1|Reported Event|Dalotuzumab 10 mg/kg Q1W (BD)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
560382|NCT00614380|B5|Baseline|Total|Total of all reporting groups
560383|NCT00614380|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560384|NCT00614380|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560385|NCT00614380|B2|Baseline|Telmisartan 80mg and Amlodipine 5mg|
560386|NCT00614380|B1|Baseline|Telmisartan 40mg and Amlodipine 5mg|
560387|NCT00614380|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560388|NCT00614380|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560389|NCT00614380|P2|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
560390|NCT00614380|P1|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
560391|NCT00614380|O3|Outcome|Pre-titration: Total|
560392|NCT00614380|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
560393|NCT00614380|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
560394|NCT00614380|O1|Outcome|Total|
560395|NCT00614380|O1|Outcome|Total|
560396|NCT00614380|O3|Outcome|Pre-antihypertensive: Total|
560397|NCT00614380|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
560398|NCT00614380|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
560399|NCT00614380|O1|Outcome|Total|
560400|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560401|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560402|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560403|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560404|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560405|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560406|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560407|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560408|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560409|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560410|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560411|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560412|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560413|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560414|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560415|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560416|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560426|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560428|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560429|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560430|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560431|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560432|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
560433|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
560434|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
560435|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
560436|NCT00614380|E2|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
560437|NCT00614380|E1|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
560438|NCT00614315|B1|Baseline|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
560439|NCT00614315|P1|Participant Flow|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
560440|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
560441|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
560442|NCT00614315|E1|Reported Event|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
560443|NCT00614198|B3|Baseline|Total|Total of all reporting groups
560444|NCT00614198|B2|Baseline|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
560445|NCT00614198|B1|Baseline|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
560446|NCT00614198|P2|Participant Flow|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
560447|NCT00614198|P1|Participant Flow|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
560448|NCT00614198|O2|Outcome|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
560449|NCT00614198|O1|Outcome|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
560450|NCT00614198|E2|Reported Event|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
560451|NCT00614198|E1|Reported Event|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
560452|NCT00614120|B5|Baseline|Total|Total of all reporting groups
560453|NCT00614120|B4|Baseline|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560454|NCT00614120|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560455|NCT00614120|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560456|NCT00614120|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560457|NCT00614120|P4|Participant Flow|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560458|NCT00614120|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560459|NCT00614120|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560460|NCT00614120|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560461|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560462|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560463|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560464|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560465|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560466|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560467|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560468|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560469|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560470|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560471|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560472|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560473|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560474|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560475|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560476|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560477|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560478|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560479|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560480|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560481|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560482|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560483|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560484|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560485|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560486|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560487|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560488|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560489|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560490|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560491|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560492|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560493|NCT00614120|E4|Reported Event|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
560494|NCT00614120|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560495|NCT00614120|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560496|NCT00614120|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
560497|NCT00614055|B4|Baseline|Total|Total of all reporting groups
560498|NCT00614055|B3|Baseline|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560499|NCT00614055|B2|Baseline|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560500|NCT00614055|B1|Baseline|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560501|NCT00614055|P3|Participant Flow|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560502|NCT00614055|P2|Participant Flow|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560503|NCT00614055|P1|Participant Flow|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560504|NCT00614055|O3|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560505|NCT00614055|O2|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560506|NCT00614055|O1|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560507|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560508|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560596|NCT00613938|B1|Baseline|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560509|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560510|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560511|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560512|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560513|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560514|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560515|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560516|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560517|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560518|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560519|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560520|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560521|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560522|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560523|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560524|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560525|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560526|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560527|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560528|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560529|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560530|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560531|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560532|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560533|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560534|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560535|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560536|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560537|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560538|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560539|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560540|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560541|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560542|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560543|NCT00614055|E3|Reported Event|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560544|NCT00614055|E2|Reported Event|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560545|NCT00614055|E1|Reported Event|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560546|NCT00613951|B4|Baseline|Total|Total of all reporting groups
560547|NCT00613951|B3|Baseline|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560548|NCT00613951|B2|Baseline|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560549|NCT00613951|B1|Baseline|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560550|NCT00613951|P3|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560551|NCT00613951|P2|Participant Flow|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560552|NCT00613951|P1|Participant Flow|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560597|NCT00613938|P4|Participant Flow|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560553|NCT00613951|O3|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560554|NCT00613951|O2|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560555|NCT00613951|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560556|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560557|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560558|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560559|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560560|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560561|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560562|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560563|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560564|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560565|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560566|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560567|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560568|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560569|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560570|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560571|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560572|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560598|NCT00613938|P3|Participant Flow|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560599|NCT00613938|P2|Participant Flow|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560573|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560574|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560575|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560576|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560577|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560578|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560579|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560580|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560581|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560582|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560583|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560584|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560585|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560586|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560587|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560588|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560589|NCT00613951|E3|Reported Event|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560590|NCT00613951|E2|Reported Event|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560591|NCT00613951|E1|Reported Event|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
560592|NCT00613938|B5|Baseline|Total|Total of all reporting groups
560593|NCT00613938|B4|Baseline|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560594|NCT00613938|B3|Baseline|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560595|NCT00613938|B2|Baseline|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560600|NCT00613938|P1|Participant Flow|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560601|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560602|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560603|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560604|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560605|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560606|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560607|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560608|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560609|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560610|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560611|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560612|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560613|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560614|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560615|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560616|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560617|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560618|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560619|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560620|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560621|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560622|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560623|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560624|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560625|NCT00613938|E4|Reported Event|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
560626|NCT00613938|E3|Reported Event|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
560627|NCT00613938|E2|Reported Event|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
560628|NCT00613938|E1|Reported Event|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
560629|NCT00613925|B3|Baseline|Total|Total of all reporting groups
560630|NCT00613925|B2|Baseline|Explora Group|Women were randomized to the Explora device for endometrial biopsy
560631|NCT00613925|B1|Baseline|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
560632|NCT00613925|P2|Participant Flow|Explora Group|Women were randomized to the Explora device for endometrial biopsy
560633|NCT00613925|P1|Participant Flow|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
560634|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
560635|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
560636|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
560637|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
560638|NCT00613925|E2|Reported Event|Explora Group|Women were randomized to the Explora device for endometrial biopsy
560639|NCT00613925|E1|Reported Event|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
560640|NCT00613821|B3|Baseline|Total|Total of all reporting groups
560641|NCT00613821|B2|Baseline|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
560642|NCT00613821|B1|Baseline|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
560643|NCT00613821|P2|Participant Flow|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
560644|NCT00613821|P1|Participant Flow|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
560645|NCT00613821|O2|Outcome|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
560646|NCT00613821|O1|Outcome|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
560743|NCT00613366|E1|Reported Event|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
561071|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
560647|NCT00613821|E2|Reported Event|Paracervical Block Only|"Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.~Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed."
560648|NCT00613821|E1|Reported Event|Lidocaine Infusion|"5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.~Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes."
560649|NCT00613730|B1|Baseline|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
560650|NCT00613730|P1|Participant Flow|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
560651|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
560652|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
560653|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
560654|NCT00613730|E1|Reported Event|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
560655|NCT00613626|B4|Baseline|Total|Total of all reporting groups
560656|NCT00613626|B3|Baseline|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560657|NCT00613626|B2|Baseline|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560658|NCT00613626|B1|Baseline|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560659|NCT00613626|P3|Participant Flow|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560807|NCT00613028|E1|Reported Event|Temozolomide Arm|Pts treated w Bev + Temozolomide
560808|NCT00613015|B7|Baseline|Total|Total of all reporting groups
560660|NCT00613626|P2|Participant Flow|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560661|NCT00613626|P1|Participant Flow|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560662|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560663|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560664|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560665|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560666|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560667|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560668|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560669|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560670|NCT00613626|O2|Outcome|Arm B: ZD6474 + Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560671|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560672|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560940|NCT00612560|P4|Participant Flow|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
560673|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560674|NCT00613626|E2|Reported Event|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
560675|NCT00613626|E1|Reported Event|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
560676|NCT00613574|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560677|NCT00613574|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560678|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560679|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560680|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560681|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560682|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560683|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560684|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560685|NCT00613574|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
560686|NCT00613509|B3|Baseline|Total|Total of all reporting groups
560687|NCT00613509|B2|Baseline|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560688|NCT00613509|B1|Baseline|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560689|NCT00613509|P2|Participant Flow|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560690|NCT00613509|P1|Participant Flow|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560691|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560692|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560693|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560694|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560695|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560696|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560697|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560698|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560699|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560700|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560701|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560702|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560703|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560704|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560705|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560706|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560707|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560708|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560709|NCT00613509|E2|Reported Event|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
560710|NCT00613509|E1|Reported Event|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
560711|NCT00613405|B3|Baseline|Total|Total of all reporting groups
560712|NCT00613405|B2|Baseline|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560713|NCT00613405|B1|Baseline|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560714|NCT00613405|P2|Participant Flow|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560715|NCT00613405|P1|Participant Flow|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560716|NCT00613405|O2|Outcome|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560717|NCT00613405|O1|Outcome|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560718|NCT00613405|E2|Reported Event|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560719|NCT00613405|E1|Reported Event|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
560720|NCT00613379|B4|Baseline|Total|Total of all reporting groups
560721|NCT00613379|B3|Baseline|Arm 3|PBO, one IV dose (N=10)
560722|NCT00613379|B2|Baseline|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
560723|NCT00613379|B1|Baseline|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
560724|NCT00613379|P3|Participant Flow|Arm 3|PBO, one IV dose (N=10)
560725|NCT00613379|P2|Participant Flow|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
560726|NCT00613379|P1|Participant Flow|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
560727|NCT00613379|O3|Outcome|Arm 3|PBO, one IV dose (N=10)
560728|NCT00613379|O2|Outcome|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
560729|NCT00613379|O1|Outcome|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
560730|NCT00613379|E3|Reported Event|Arm 3|PBO, one IV dose (N=10)
560731|NCT00613379|E2|Reported Event|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
560732|NCT00613379|E1|Reported Event|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
560733|NCT00613366|B3|Baseline|Total|Total of all reporting groups
560734|NCT00613366|B2|Baseline|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
560735|NCT00613366|B1|Baseline|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
560736|NCT00613366|P2|Participant Flow|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
560737|NCT00613366|P1|Participant Flow|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
560738|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
560739|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
560740|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
560741|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
560742|NCT00613366|E2|Reported Event|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
560744|NCT00613327|B1|Baseline|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560745|NCT00613327|P1|Participant Flow|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560746|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560747|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560748|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560749|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560750|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560751|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560752|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560753|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560754|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560755|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560756|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560757|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560758|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560759|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560760|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560761|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560809|NCT00613015|B6|Baseline|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
560762|NCT00613327|E1|Reported Event|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
560763|NCT00613314|B1|Baseline|Telmisartan (Micardis)|
560764|NCT00613314|P1|Participant Flow|Telmisartan (Micardis)|
560765|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
560766|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
560767|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
560768|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
560769|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
560770|NCT00613314|E1|Reported Event|Telmisartan (Micardis)|
560771|NCT00613301|B1|Baseline|Pramipexole|The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations.
560772|NCT00613301|P1|Participant Flow|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
560773|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
560774|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
560775|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
560776|NCT00613301|O1|Outcome|Pramipexole|Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
560777|NCT00613301|E1|Reported Event|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
560778|NCT00613106|B3|Baseline|Total|Total of all reporting groups
560779|NCT00613106|B2|Baseline|Ibuprofen|Ibuprofen 800mg
560780|NCT00613106|B1|Baseline|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
560781|NCT00613106|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg
560782|NCT00613106|P1|Participant Flow|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
560783|NCT00613106|O2|Outcome|Ibuprofen|Ibuprofen 800mg
560784|NCT00613106|O1|Outcome|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
560785|NCT00613106|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
560786|NCT00613106|E1|Reported Event|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
560787|NCT00613080|B1|Baseline|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
560788|NCT00613080|P1|Participant Flow|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
560789|NCT00613080|O1|Outcome|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
560790|NCT00613080|E1|Reported Event|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
560791|NCT00613028|B3|Baseline|Total|Total of all reporting groups
560792|NCT00613028|B2|Baseline|Etoposide Arm|Pts treated w Bev + Etoposide
560793|NCT00613028|B1|Baseline|Temozolomide Arm|Pts treated w Bev + Temozolomide
560794|NCT00613028|P2|Participant Flow|Etoposide Arm|Bevacizumab + Etoposide: Patients who progressed or had grade 3 or greater toxicity related to prior daily temozolomide dosing, but have not had prior progression or grade 3 or greater toxicity related to prior daily etoposide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Etoposide will be administered once daily at 50 mg/m^2/day for the first 21 days of each 28-day cycle.
560795|NCT00613028|P1|Participant Flow|Temozolomide Arm|Bevacizumab + Temozolomide: Patients who progressed or had grade 3 or greater toxicity related to prior daily etoposide dosing, but have not had prior progression or grade 3 toxicity related to prior daily temozolomide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Temozolomide will be administered ona continuous daily dosing schedule at 50 mg/m^2/day.
560796|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
560797|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
560798|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
560799|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
560800|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
560801|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
560802|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
560803|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
560804|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
560805|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
560806|NCT00613028|E2|Reported Event|Etoposide Arm|Pts treated w Bev + Etoposide
560810|NCT00613015|B5|Baseline|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
560811|NCT00613015|B4|Baseline|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
560812|NCT00613015|B3|Baseline|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
560813|NCT00613015|B2|Baseline|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
560814|NCT00613015|B1|Baseline|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
560815|NCT00613015|P6|Participant Flow|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
560816|NCT00613015|P5|Participant Flow|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
560817|NCT00613015|P4|Participant Flow|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
560818|NCT00613015|P3|Participant Flow|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
560819|NCT00613015|P2|Participant Flow|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
560820|NCT00613015|P1|Participant Flow|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
560821|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
560822|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
560823|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
560824|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
560825|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
560826|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
560827|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
560828|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
560829|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
560830|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
560831|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
560832|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
560833|NCT00613015|E6|Reported Event|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
560834|NCT00613015|E5|Reported Event|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
560835|NCT00613015|E4|Reported Event|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
560836|NCT00613015|E3|Reported Event|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
560837|NCT00613015|E2|Reported Event|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
560838|NCT00613015|E1|Reported Event|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
560839|NCT00612924|B3|Baseline|Total|Total of all reporting groups
560840|NCT00612924|B2|Baseline|ONE-LOK|
560841|NCT00612924|B1|Baseline|Anaconda|The original protocol identified that the Anaconda™ Stent Graft System would be used throughout the current Phase II study. However, a modified device design became available during the course of the current Phase II study and is called the ONELOK™ Stent Graft System. As the modifications to the device design are considered minor, there are no expected differences in the anticipated safety or effectiveness of the device. The design changes relate primary to a uni-docking zone in the bifurcate body to maximize sizing compatibilities between the bifurcate body and the iliac limbs.
560842|NCT00612924|P2|Participant Flow|ONE-LOK|
560843|NCT00612924|P1|Participant Flow|Anaconda|
560844|NCT00612924|O2|Outcome|ONE LOK|
560845|NCT00612924|O1|Outcome|Anaconda|
560846|NCT00612924|O3|Outcome|Total|
560847|NCT00612924|O2|Outcome|ONE LOK|
560848|NCT00612924|O1|Outcome|Anaconda|
560849|NCT00612924|O2|Outcome|ONE LOK|
560850|NCT00612924|O1|Outcome|Anaconda|
560851|NCT00612924|E2|Reported Event|ONE-LOK|
560852|NCT00612924|E1|Reported Event|Anaconda|
560853|NCT00612807|B3|Baseline|Total|Total of all reporting groups
560854|NCT00612807|B2|Baseline|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
560855|NCT00612807|B1|Baseline|Semi-weekly Medication Management|Medication management with a study doctor every other week.
560856|NCT00612807|P2|Participant Flow|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
560857|NCT00612807|P1|Participant Flow|Semi-weekly Medication Management|Medication management with a study doctor every other week.
560858|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
560859|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
560860|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
560861|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
560862|NCT00612807|E2|Reported Event|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
560863|NCT00612807|E1|Reported Event|Semi-weekly Medication Management|Medication management with a study doctor every other week.
560864|NCT00612768|B1|Baseline|Sensitive Subjects|Subjects with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
560865|NCT00612768|P1|Participant Flow|Sensitive Subjects|All subjects recruited to this study were to have had previous positive patch test results to one of the allergens tested on the study.
560866|NCT00612768|O8|Outcome|Persistent Reactions: Thimerosal in PVP|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
560867|NCT00612768|O7|Outcome|Persistent Reactions: Thimerosal in HPC|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
560868|NCT00612768|O6|Outcome|Persistent Reactions: Fragrance Mix in PVP|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
560869|NCT00612768|O5|Outcome|Persistent Reactions: Fragrance Mix in HPC|Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
560870|NCT00612768|O4|Outcome|Late Reactions: Thimerosol in PVP|Late reactions occur 7-10 days after patch application
560871|NCT00612768|O3|Outcome|Late Reactions: Thimerosal in HPC|Late reactions occur 7-10 days after patch application
560872|NCT00612768|O2|Outcome|Late Reactions: Fragrance Mix in PVP|Late reactions occur 7-10 days after patch application
560873|NCT00612768|O1|Outcome|Late Reactions: Fragrance Mix in HPC|Late reactions occur 7-10 days after patch application
560874|NCT00612768|O4|Outcome|Itching and Burning|Percentage of participants who reported patch related itching and/or burning at visit 2
560875|NCT00612768|O3|Outcome|Incomplete Panel Adhesion: Reference Allergen|Percentage of participants whose panels were not 100% adhered at visit 2.
560876|NCT00612768|O2|Outcome|Incomplete Panel Adhesion: TRUE Test|Percentage of participants whose panels were not 100% adhered at visit 2.
560877|NCT00612768|O1|Outcome|Tape Irritation: TRUE Test Panel|Percentage of participants who exhibited tape-induced irritation at visit 2.
560878|NCT00612768|O8|Outcome|Specificity: Thimerosal in PVP|Agreement between negative results for the test and reference allergen
560879|NCT00612768|O7|Outcome|Specificity: Thimerosal in HPC|Agreement between negative results for the test and reference allergen
560880|NCT00612768|O6|Outcome|Specificity: Fragrance Mix in PVP|Agreement between negative results for the test and reference allergen
560881|NCT00612768|O5|Outcome|Specificity: Fragrance Mix in HPC|Agreement between negative results for the test and reference allergen
560882|NCT00612768|O4|Outcome|Sensitivity: Thimerosol in PVP|Agreement between positive results for the test and reference allergen
560883|NCT00612768|O3|Outcome|Sensitivity: Thimerosal in HPC|Agreement between positive results for the test and reference allergen
560884|NCT00612768|O2|Outcome|Sensitivity: Fragrance Mix in PVP|Agreement between positive results for the test and reference allergen
560885|NCT00612768|O1|Outcome|Sensitivity: Fragrance Mix in HPC|Agreement between positive results for the test and reference allergen
560886|NCT00612768|O2|Outcome|Thimerosol|Percent agreement between T.R.U.E. Test allergen in PVP vs HPC
560887|NCT00612768|O1|Outcome|Fragrance Mix|Percent agreement between T.R.U.E. Test allergen in PVP vs HPC
560888|NCT00612768|E1|Reported Event|Sensitives|subjects per allergen with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria.
560889|NCT00612690|B3|Baseline|Total|Total of all reporting groups
560890|NCT00612690|B2|Baseline|Services As Usual|Referral to nearby community mental heath agencies for clinic-based services where participants received standard care for mental health-related problems.
560891|NCT00612690|B1|Baseline|Links to Learning|Mental health intervention focused on enhancing the predictors of young children's school success
560892|NCT00612690|P2|Participant Flow|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
560893|NCT00612690|P1|Participant Flow|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
560894|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
560895|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
560896|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services where participants received standard care for mental health-related problems."
560897|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
560898|NCT00612690|E2|Reported Event|Services as Usual|"Participants will receive treatment as usual and referrals.~Treatment as usual (TAU) : TAU includes referral to community mental health clinic-based services, where participants will receive standard care for mental health-related problems."
560899|NCT00612690|E1|Reported Event|Links to Learning|"Participants will undergo the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program includes collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
560900|NCT00612677|B1|Baseline|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
560901|NCT00612677|P1|Participant Flow|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
560902|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
560903|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
560904|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
560905|NCT00612677|E1|Reported Event|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
560906|NCT00612573|B5|Baseline|Total|Total of all reporting groups
560907|NCT00612573|B4|Baseline|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
560908|NCT00612573|B3|Baseline|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
560909|NCT00612573|B2|Baseline|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
560910|NCT00612573|B1|Baseline|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
560911|NCT00612573|P4|Participant Flow|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
560912|NCT00612573|P3|Participant Flow|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
560913|NCT00612573|P2|Participant Flow|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
560914|NCT00612573|P1|Participant Flow|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
560915|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
560916|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
560917|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
560918|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
560919|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
560920|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
560921|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
560922|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
560923|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
560924|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
560925|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
560926|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
560927|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
560928|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
560929|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
560930|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
560931|NCT00612573|E4|Reported Event|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
560932|NCT00612573|E3|Reported Event|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
560933|NCT00612573|E2|Reported Event|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
560934|NCT00612573|E1|Reported Event|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
560935|NCT00612560|B5|Baseline|Total|Total of all reporting groups
560936|NCT00612560|B4|Baseline|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
560937|NCT00612560|B3|Baseline|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
560938|NCT00612560|B2|Baseline|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
560939|NCT00612560|B1|Baseline|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
560941|NCT00612560|P3|Participant Flow|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
560942|NCT00612560|P2|Participant Flow|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
560943|NCT00612560|P1|Participant Flow|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
560944|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
560945|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
560946|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
560947|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
560948|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
560949|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
560950|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
560951|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
560952|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
560953|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
560954|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
560955|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
560956|NCT00612560|O4|Outcome|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
560957|NCT00612560|O3|Outcome|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
560958|NCT00612560|O2|Outcome|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
560959|NCT00612560|O1|Outcome|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
560960|NCT00612560|E4|Reported Event|Arm D - Placebo|"Placebo pill 1 per day~Placebo: Placebo pill 1 per day"
560961|NCT00612560|E3|Reported Event|Arm C - Anastrozole|"Anastrozole 1 mg pill per day~Anastrozole: 1 mg per day"
560962|NCT00612560|E2|Reported Event|Arm B - Flaxseed|"Flaxseed 25 mg per day and 1 placebo pill per day~flaxseed: 25 g per day ground"
560963|NCT00612560|E1|Reported Event|Arm A - Flaxseed & Active Anastrazole|"25 mg flaxseed per day and 1 mg anastrozole pill per day~Anastrozole: 1 mg per day~flaxseed: 25 g per day ground"
560964|NCT00612534|B5|Baseline|Total|Total of all reporting groups
560965|NCT00612534|B4|Baseline|Placebo NanoTab|
560966|NCT00612534|B3|Baseline|Sufentanil NanoTab 15 Mcg|
560967|NCT00612534|B2|Baseline|Sufentanil NanoTab 10 Mcg|
560968|NCT00612534|B1|Baseline|Sufentanil NanoTab 5 Mcg|
560969|NCT00612534|P4|Participant Flow|Placebo NanoTab|
560970|NCT00612534|P3|Participant Flow|Sufentanil NanoTab 15 Mcg|
560971|NCT00612534|P2|Participant Flow|Sufentanil NanoTab 10 Mcg|
560972|NCT00612534|P1|Participant Flow|Sufentanil NanoTab 5 Mcg|
560973|NCT00612534|O4|Outcome|Placebo NanoTab|
560974|NCT00612534|O3|Outcome|Sufentanil NanoTab 15 Mcg|
560975|NCT00612534|O2|Outcome|Sufentanil NanoTab 10 Mcg|
560976|NCT00612534|O1|Outcome|Sufentanil NanoTab 5 Mcg|
560977|NCT00612534|E4|Reported Event|Placebo NanoTab|
560978|NCT00612534|E3|Reported Event|Sufentanil NanoTab 15 Mcg|
560979|NCT00612534|E2|Reported Event|Sufentanil NanoTab 10 Mcg|
560980|NCT00612534|E1|Reported Event|Sufentanil NanoTab 5 Mcg|
560981|NCT00612508|B3|Baseline|Total|Total of all reporting groups
560982|NCT00612508|B2|Baseline|NuvaRing|intravaginal contraception
560983|NCT00612508|B1|Baseline|Desogen|oral contraceptive
560984|NCT00612508|P2|Participant Flow|NuvaRing|intravaginal contraception
560985|NCT00612508|P1|Participant Flow|Desogen|oral contraceptive
560986|NCT00612508|O2|Outcome|Intravaginal Ring Contraceptive|nuvaring (ethinyl estradiol & desogestrel) = R (ring)
560987|NCT00612508|O1|Outcome|Oral Contraceptive|Desogen (ethinyl estradiol & desogestrel) = P (pill)
560988|NCT00612508|O2|Outcome|NuvaRing|intravaginal contraception = R (ring)
560989|NCT00612508|O1|Outcome|Desogen|oral contraceptive = P (pill)
560990|NCT00612508|E2|Reported Event|NuvaRing|intravaginal contraception
560991|NCT00612508|E1|Reported Event|Desogen|oral contraceptive
560992|NCT00612456|B4|Baseline|Total|Total of all reporting groups
560993|NCT00612456|B3|Baseline|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
560994|NCT00612456|B2|Baseline|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
560995|NCT00612456|B1|Baseline|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses..
560996|NCT00612456|P3|Participant Flow|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
560997|NCT00612456|P2|Participant Flow|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561026|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
560998|NCT00612456|P1|Participant Flow|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 milligrams per milliliter (mg/mL) three time daily (TID) for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
560999|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561000|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561001|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561002|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561003|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561004|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561005|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561006|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561007|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561008|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561009|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561010|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561011|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561012|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561013|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561014|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561015|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561016|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561017|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561018|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561019|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561020|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561021|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561022|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561023|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561024|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561025|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561069|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561070|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561027|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561028|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561029|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561030|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561031|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561032|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561033|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops approximately with a 6-hour interval between daily doses.
561034|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops approximately with a 6-hour interval between daily doses.
561035|NCT00612456|O3|Outcome|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561036|NCT00612456|O2|Outcome|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561037|NCT00612456|O1|Outcome|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561038|NCT00612456|E3|Reported Event|Pazopanib 5 mg/mL Once Daily|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL once daily for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561039|NCT00612456|E2|Reported Event|Pazopanib 2 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 2 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561040|NCT00612456|E1|Reported Event|Pazopanib 5 mg/mL TID|Eligible participants received Pazopanib eye drops topically at a dose of 5 mg/mL TID for 28 days. Participants were instructed to administer drops with a 6-hour interval between daily doses.
561041|NCT00612430|B3|Baseline|Total|Total of all reporting groups
561042|NCT00612430|B2|Baseline|Grade IV|
561043|NCT00612430|B1|Baseline|Grade III|
561044|NCT00612430|P2|Participant Flow|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
561045|NCT00612430|P1|Participant Flow|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
561046|NCT00612430|O2|Outcome|Grade IV|
561047|NCT00612430|O1|Outcome|Grade III|
561048|NCT00612430|O2|Outcome|Grade IV|
561049|NCT00612430|O1|Outcome|Grade III|
561050|NCT00612430|O2|Outcome|Grade IV|
561051|NCT00612430|O1|Outcome|Grade III|
561052|NCT00612430|O2|Outcome|Grade IV|
561053|NCT00612430|O1|Outcome|Grade III|
561054|NCT00612430|O2|Outcome|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
561055|NCT00612430|O1|Outcome|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
561056|NCT00612430|E2|Reported Event|Grade IV|
561057|NCT00612430|E1|Reported Event|Grade III|
561058|NCT00612352|B3|Baseline|Total|Total of all reporting groups
561059|NCT00612352|B2|Baseline|Family History Negative|Subjects with no family history of alcoholism.
561060|NCT00612352|B1|Baseline|Family History Positive|Subjects with a positive family history of alcoholism.
561061|NCT00612352|P2|Participant Flow|Family History Negative|Subjects with no family history of alcoholism.
561062|NCT00612352|P1|Participant Flow|Family History Positive|Subjects with a positive family history of alcoholism.
561063|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561064|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561065|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561066|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561067|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561068|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561072|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561073|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561074|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561075|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561076|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561077|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561078|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561079|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561080|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561081|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561082|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561083|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561084|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561085|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561086|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561087|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561088|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561089|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561090|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561091|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561092|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561093|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561094|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561095|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561096|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561097|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561098|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561099|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561100|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561101|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561102|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561103|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561104|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561105|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561106|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561107|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561108|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561109|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561110|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561111|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561112|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561113|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561114|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561115|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561116|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561117|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561118|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561119|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561120|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561121|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561122|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561123|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561124|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561125|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561126|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561127|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561128|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561129|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561130|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561131|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561132|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561133|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561134|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561135|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561136|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561137|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561138|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561139|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561140|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561141|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561142|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561143|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561144|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561145|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561146|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561147|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561148|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561149|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561150|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561151|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561152|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561153|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561154|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561155|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561156|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561157|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561158|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561159|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561160|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561161|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561162|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561163|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561164|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561165|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561166|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561167|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561168|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561169|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561170|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561171|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
561172|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
561173|NCT00612352|E2|Reported Event|Family History Negative|Subjects with no family history of alcoholism.
561174|NCT00612352|E1|Reported Event|Family History Positive|Subjects with a positive family history of alcoholism.
561175|NCT00612339|B1|Baseline|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
561176|NCT00612339|P1|Participant Flow|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
561177|NCT00612339|O1|Outcome|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
561178|NCT00612339|E1|Reported Event|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
561179|NCT00612313|B3|Baseline|Total|Total of all reporting groups
561180|NCT00612313|B2|Baseline|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants attended 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
561181|NCT00612313|B1|Baseline|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
561182|NCT00612313|P2|Participant Flow|Continued Medication Plus CBT|"n=75 Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
561183|NCT00612313|P1|Participant Flow|Continued Medication Alone|"n=69 Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
561184|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
561185|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
561186|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~Treatment was uncontrolled after week 30."
561187|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Treatment was uncontrolled after week 30."
561188|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~Treatment was uncontrolled after week 30."
561189|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Treatment was uncontrolled after week 30."
561190|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~n=75"
561191|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~n=69"
561192|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
561193|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
561194|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
561195|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
561196|NCT00612313|E2|Reported Event|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~N=75"
561197|NCT00612313|E1|Reported Event|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~N=69"
561198|NCT00612222|B1|Baseline|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
561199|NCT00612222|P1|Participant Flow|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
561200|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
561201|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
561202|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
561203|NCT00612222|E1|Reported Event|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
561204|NCT00612105|B3|Baseline|Total|Total of all reporting groups
561205|NCT00612105|B2|Baseline|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561206|NCT00612105|B1|Baseline|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561207|NCT00612105|P2|Participant Flow|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561208|NCT00612105|P1|Participant Flow|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561209|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561210|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561211|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561212|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561213|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561214|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561215|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561216|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561217|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561218|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561219|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561220|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561221|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561222|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561223|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561267|NCT00612040|P1|Participant Flow|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561268|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561224|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561225|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561226|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561227|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561228|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561229|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561230|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561231|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561232|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561233|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561234|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561235|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561269|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561270|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561236|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561237|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561238|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561239|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561240|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561241|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561242|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561243|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561244|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561245|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561246|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561247|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561271|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561272|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561248|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561249|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561250|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561251|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561252|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561253|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561254|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561255|NCT00612105|E2|Reported Event|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
561256|NCT00612105|E1|Reported Event|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
561257|NCT00612066|B1|Baseline|Rosiglitazone|Rosiglitazone maleate :
561258|NCT00612066|P1|Participant Flow|Rosiglitazone|Rosiglitazone maleate :
561259|NCT00612066|O1|Outcome|Rosiglitazone|Rosiglitazone maleate :
561260|NCT00612066|E1|Reported Event|Rosiglitazone|Rosiglitazone maleate :
561261|NCT00612040|B4|Baseline|Total|Total of all reporting groups
561262|NCT00612040|B3|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561263|NCT00612040|B2|Baseline|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561264|NCT00612040|B1|Baseline|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561265|NCT00612040|P3|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561266|NCT00612040|P2|Participant Flow|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561273|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561274|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561275|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561276|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561277|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561278|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561279|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561280|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561281|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561282|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561283|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561284|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561285|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561286|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561287|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561288|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561289|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561290|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561291|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561292|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561293|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561294|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561295|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561296|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561325|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561297|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561298|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561299|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561300|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561301|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561302|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561303|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561304|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561305|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561306|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561307|NCT00612040|E3|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561308|NCT00612040|E2|Reported Event|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561309|NCT00612040|E1|Reported Event|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
561310|NCT00611897|B1|Baseline|Overall Sample|This is the group of healthy volunteers that consented to participate in the study.
561311|NCT00611897|P2|Participant Flow|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
561312|NCT00611897|P1|Participant Flow|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
561313|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561314|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561315|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561316|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561317|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561318|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561319|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561320|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561321|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561322|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561323|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561324|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561326|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561327|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561328|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561329|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561330|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561331|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
561332|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
561333|NCT00611897|E2|Reported Event|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
561334|NCT00611897|E1|Reported Event|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
561335|NCT00611884|B5|Baseline|Total|Total of all reporting groups
561336|NCT00611884|B4|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561337|NCT00611884|B3|Baseline|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561338|NCT00611884|B2|Baseline|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561339|NCT00611884|B1|Baseline|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561340|NCT00611884|P4|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561341|NCT00611884|P3|Participant Flow|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561342|NCT00611884|P2|Participant Flow|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561343|NCT00611884|P1|Participant Flow|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561344|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561345|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561346|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561347|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561348|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561349|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561426|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561350|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561351|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561352|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561353|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561354|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561355|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561356|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561357|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561358|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561359|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561360|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561361|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561362|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561363|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561364|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561365|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561366|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561367|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561368|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561369|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561370|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561427|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561428|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561371|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561372|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561373|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561374|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561375|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561376|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561377|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561378|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561379|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561380|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561381|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561382|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561383|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561384|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561385|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561386|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561387|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561388|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561389|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561390|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561391|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561392|NCT00611884|E4|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561393|NCT00611884|E3|Reported Event|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
561394|NCT00611884|E2|Reported Event|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
561395|NCT00611884|E1|Reported Event|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
561396|NCT00611806|B3|Baseline|Total|Total of all reporting groups
561397|NCT00611806|B2|Baseline|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
561398|NCT00611806|B1|Baseline|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
561399|NCT00611806|P2|Participant Flow|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
561400|NCT00611806|P1|Participant Flow|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
561401|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
561402|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
561403|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
561404|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
561405|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
561406|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
561407|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
561408|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
561409|NCT00611806|E2|Reported Event|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
561410|NCT00611806|E1|Reported Event|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
561411|NCT00611767|B3|Baseline|Total|Total of all reporting groups
561412|NCT00611767|B2|Baseline|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.
561413|NCT00611767|B1|Baseline|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
561414|NCT00611767|P2|Participant Flow|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).
561415|NCT00611767|P1|Participant Flow|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
561416|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561417|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561418|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561419|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561420|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561421|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561422|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561423|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561424|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561425|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561429|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561430|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561431|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561432|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561433|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561434|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561435|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561436|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561437|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561438|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561439|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561440|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561441|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561442|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561443|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561444|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561445|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561446|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561447|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561448|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561449|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561450|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561451|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561452|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561453|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561454|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561455|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561456|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561457|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561458|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561459|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561460|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561461|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561462|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561463|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561464|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561465|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561466|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561467|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561468|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561469|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561470|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561471|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561472|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561473|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561474|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561475|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561476|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561477|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561574|NCT00611715|B3|Baseline|Total|Total of all reporting groups
561478|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561479|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561480|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561481|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561482|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561483|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561484|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561485|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561486|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561487|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561488|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561489|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561490|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561491|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561492|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561493|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561494|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561495|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561496|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561497|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561498|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561499|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561500|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561501|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561502|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561503|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561504|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561505|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561506|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561507|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561508|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561509|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561510|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561511|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561512|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561513|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561514|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561515|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561516|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561517|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561518|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561519|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561520|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561521|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561522|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561523|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561524|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561525|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561526|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561839|NCT00611403|P2|Participant Flow|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
561527|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561528|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561529|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561530|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561531|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561532|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561533|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561534|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561535|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561536|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561537|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561538|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561539|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561540|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561541|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561542|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561543|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561544|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561545|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561546|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561547|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561548|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561549|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561550|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561551|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561552|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561553|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561554|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561555|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561556|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561557|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561558|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561559|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561560|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561561|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561562|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561563|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561564|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561565|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561566|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561567|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561568|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561569|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561570|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
561571|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
561572|NCT00611767|E2|Reported Event|Family History Positive for Alcoholism|"Family History Positive for Alcoholism subjects will receive 2 interventions~Placebo: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
561573|NCT00611767|E1|Reported Event|Family History Negative for Alcoholism|"Family History Negative for Alcoholism subjects will receive 2 interventions~Thiopental: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
561575|NCT00611715|B2|Baseline|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
561576|NCT00611715|B1|Baseline|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
561577|NCT00611715|P2|Participant Flow|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
561578|NCT00611715|P1|Participant Flow|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
561579|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
561580|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
561581|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy
561582|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naive in the metastatic setting and more than 12 months from adjuvant endocrine therapy
561583|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
561584|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
561585|NCT00611715|O2|Outcome|Previous Hormone Therapy|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
561586|NCT00611715|O1|Outcome|Hormone Therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
561587|NCT00611715|E2|Reported Event|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
561588|NCT00611715|E1|Reported Event|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
561589|NCT00611624|B1|Baseline|Five Days of Mammosite Therapy|
561590|NCT00611624|P1|Participant Flow|Five Days of Mammosite Therapy|Five Days of Mammosite Therapy (Radiotherapy)
561591|NCT00611624|O1|Outcome|Patient Characteristics|Twenty-eight women in total were enrolled and had been treated on this trial at the time of analysis (12 additional patients accrued after the initial phase of 16 patients).
561592|NCT00611624|O1|Outcome|Five Days of Mammosite Therapy|
561593|NCT00611624|E1|Reported Event|Five Days of Mammosite Therapy|
561594|NCT00611559|B4|Baseline|Total|Total of all reporting groups
561595|NCT00611559|B3|Baseline|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561596|NCT00611559|B2|Baseline|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561597|NCT00611559|B1|Baseline|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561598|NCT00611559|P3|Participant Flow|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561599|NCT00611559|P2|Participant Flow|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561600|NCT00611559|P1|Participant Flow|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561601|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561602|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561603|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561604|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561605|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561606|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561607|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561608|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561609|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561610|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561611|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561612|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561613|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561614|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561615|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561616|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561617|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561618|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561619|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561620|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561621|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561622|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561623|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561624|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561625|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561626|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561627|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561628|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561629|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561630|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561631|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561632|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561633|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561634|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561635|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561636|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561637|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561638|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561639|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561640|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561641|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561642|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561643|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561644|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561645|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561646|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561647|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561648|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561649|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561650|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561651|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561652|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561653|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561654|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561655|NCT00611559|E3|Reported Event|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
561656|NCT00611559|E2|Reported Event|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
561657|NCT00611559|E1|Reported Event|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
561658|NCT00611533|B1|Baseline|All Study Participants|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
561659|NCT00611533|P2|Participant Flow|Placebo Then Atomoxetine|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
561660|NCT00611533|P1|Participant Flow|Atomoxetine Then Placebo|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
561661|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561662|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561663|NCT00611533|O1|Outcome|Baseline|
561664|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561665|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561666|NCT00611533|O1|Outcome|Baseline|
561667|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561668|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561669|NCT00611533|O1|Outcome|Baseline|
561670|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561671|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561672|NCT00611533|O1|Outcome|Baseline|
561673|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561674|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561675|NCT00611533|O1|Outcome|Baseline|
561676|NCT00611533|E2|Reported Event|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561677|NCT00611533|E1|Reported Event|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
561678|NCT00611468|B1|Baseline|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561679|NCT00611468|P4|Participant Flow|PK Group for Additional PK Data|Additional patients were enrolled for enhanced PK parameter estimation
561680|NCT00611468|P3|Participant Flow|Dosage Level 3 for MTD Determination|Dosage level 3 was topotecan 1.25 mg/m2 and erlotinib 150 mg.
561681|NCT00611468|P2|Participant Flow|Dosage Level 2 for MTD Determination|Dosage level 2 was topotecan 1.0 mg/m2 and erlotinib 150 mg.
561682|NCT00611468|P1|Participant Flow|Dosage Level 1 for MTD Determination|Dosage level 1 was topotecan 0.75 mg/m2 and erlotinib 150 mg.
561683|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561684|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561685|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561686|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561687|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561688|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561689|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561690|NCT00611468|E1|Reported Event|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
561691|NCT00611455|B3|Baseline|Total|Total of all reporting groups
561692|NCT00611455|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561693|NCT00611455|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561694|NCT00611455|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561695|NCT00611455|P2|Participant Flow|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561696|NCT00611455|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561697|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561778|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561698|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561699|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561700|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561701|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561702|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561703|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561704|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561705|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561706|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561707|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561708|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561709|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561710|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561711|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561712|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561832|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
561713|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561714|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561715|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561716|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561717|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561718|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561719|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561720|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561721|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561722|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561723|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561724|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561725|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561726|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561727|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561833|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
561728|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561729|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561730|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561731|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561732|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561733|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561734|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561735|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561736|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561737|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561738|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561739|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561740|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561741|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561742|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561834|NCT00611442|E2|Reported Event|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
561743|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561744|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561745|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561746|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561747|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561748|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561749|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561750|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561751|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561752|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561753|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561754|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561755|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561756|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561757|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561835|NCT00611442|E1|Reported Event|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
561836|NCT00611403|B3|Baseline|Total|Total of all reporting groups
561758|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561759|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561760|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561761|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561762|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561763|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561764|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561765|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561766|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561767|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561768|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561769|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561770|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561771|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561772|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561773|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561774|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561775|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561776|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561777|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561837|NCT00611403|B2|Baseline|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
561779|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561780|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561781|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561782|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561783|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561784|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561785|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561786|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561787|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561788|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561789|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561790|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561791|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561792|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561793|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561794|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561795|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561796|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561797|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561798|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561799|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561800|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561801|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561802|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561803|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561838|NCT00611403|B1|Baseline|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
561804|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561805|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561806|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561807|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561808|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561809|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561810|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561811|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561812|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561813|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561814|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561815|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561816|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561817|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
561818|NCT00611455|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
561819|NCT00611455|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
561820|NCT00611455|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
561821|NCT00611442|B3|Baseline|Total|Total of all reporting groups
561822|NCT00611442|B2|Baseline|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
561823|NCT00611442|B1|Baseline|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
561824|NCT00611442|P2|Participant Flow|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
561825|NCT00611442|P1|Participant Flow|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
561826|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
561827|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
561828|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
561829|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
561830|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
561831|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
561840|NCT00611403|P1|Participant Flow|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
561841|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
561842|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
561843|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
561844|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
561845|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
561846|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
561847|NCT00611403|E2|Reported Event|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
561848|NCT00611403|E1|Reported Event|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
561849|NCT00611351|B1|Baseline|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
561850|NCT00611351|P1|Participant Flow|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
561851|NCT00611351|O1|Outcome|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
561852|NCT00611351|O1|Outcome|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
561853|NCT00611351|O1|Outcome|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
561854|NCT00611351|O1|Outcome|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
561855|NCT00611351|E1|Reported Event|Unrelated Donor Allogeneic|Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
561856|NCT00611325|B3|Baseline|Total|Total of all reporting groups
561857|NCT00611325|B2|Baseline|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561858|NCT00611325|B1|Baseline|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561859|NCT00611325|P2|Participant Flow|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561860|NCT00611325|P1|Participant Flow|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561861|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561862|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561863|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561864|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561865|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561866|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561867|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561868|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561869|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561870|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
561871|NCT00611325|E2|Reported Event|Non-EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs."
561910|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561872|NCT00611325|E1|Reported Event|EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 2.5 mg/m2 for patients taking EIAEDs."
561873|NCT00611247|B3|Baseline|Total|Total of all reporting groups
561874|NCT00611247|B2|Baseline|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
561875|NCT00611247|B1|Baseline|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
561876|NCT00611247|P2|Participant Flow|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
561877|NCT00611247|P1|Participant Flow|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
561878|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
561879|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
561880|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
561881|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
561882|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
561883|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
561884|NCT00611247|E2|Reported Event|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
561885|NCT00611247|E1|Reported Event|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
561886|NCT00611130|B3|Baseline|Total|Total of all reporting groups
561887|NCT00611130|B2|Baseline|Placebo|Matching Placebo Tablets. 3 tablets bid.
561888|NCT00611130|B1|Baseline|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
561889|NCT00611130|P2|Participant Flow|Placebo|Matching Placebo Tablets. 3 tablets bid.
561890|NCT00611130|P1|Participant Flow|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
561891|NCT00611130|O1|Outcome|Treatment Phase Completers|Up to 12 urine specimens out of 37 collected during the Treatment Phase completers were analyzed for vigabatrin levels.
561892|NCT00611130|O2|Outcome|Matching Placebo Tablets|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
561893|NCT00611130|O1|Outcome|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks, computerized cognitive behavioral therapy plus contingency management.Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin) and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) for efficacy and safety assessments and for treatment during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
561894|NCT00611130|E2|Reported Event|Matching Placebo Tablet|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
561895|NCT00611130|E1|Reported Event|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
561896|NCT00611026|B4|Baseline|Total|Total of all reporting groups
561897|NCT00611026|B3|Baseline|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561898|NCT00611026|B2|Baseline|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561899|NCT00611026|B1|Baseline|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561900|NCT00611026|P3|Participant Flow|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561901|NCT00611026|P2|Participant Flow|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561902|NCT00611026|P1|Participant Flow|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561903|NCT00611026|O2|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561904|NCT00611026|O1|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561905|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561906|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561907|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561908|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561909|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561911|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561912|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561913|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561914|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561915|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561916|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561917|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561918|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561919|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561920|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561921|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561922|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561923|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561924|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561925|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561926|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561927|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561928|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561929|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561930|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561931|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561932|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561933|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561934|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561935|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561936|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561937|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561938|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561939|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561940|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561941|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561942|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561943|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561944|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561945|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561946|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561947|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561948|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561949|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561950|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561951|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561952|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561953|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561954|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561955|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561956|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561957|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561958|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561959|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561960|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561961|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561962|NCT00611026|E3|Reported Event|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
561963|NCT00611026|E2|Reported Event|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
561964|NCT00611026|E1|Reported Event|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
561965|NCT00610987|B3|Baseline|Total|Total of all reporting groups
561966|NCT00610987|B2|Baseline|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
561967|NCT00610987|B1|Baseline|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
561968|NCT00610987|P2|Participant Flow|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
561969|NCT00610987|P1|Participant Flow|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
561970|NCT00610987|O2|Outcome|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
561971|NCT00610987|O1|Outcome|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
561972|NCT00610987|E2|Reported Event|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
561973|NCT00610987|E1|Reported Event|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
561974|NCT00610883|B1|Baseline|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
561975|NCT00610883|P1|Participant Flow|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
561976|NCT00610883|O1|Outcome|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
561977|NCT00610883|E1|Reported Event|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
561978|NCT00610857|B1|Baseline|Interferon Alfa-2b + Tremelimumab|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
561979|NCT00610857|P1|Participant Flow|Interferon Alfa-2b + Tremelimumab|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy
561980|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
561981|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
561982|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
561983|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
561984|NCT00610857|E1|Reported Event|Interferon Alfa-2b + Tremelimumab (Related and Unrelated AEs)|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks per cycle.
561985|NCT00610740|B1|Baseline|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
561986|NCT00610740|P1|Participant Flow|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
561987|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
561988|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
561989|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
561990|NCT00610740|E1|Reported Event|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
561991|NCT00610714|B3|Baseline|Total|Total of all reporting groups
561992|NCT00610714|B2|Baseline|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
561993|NCT00610714|B1|Baseline|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
561994|NCT00610714|P2|Participant Flow|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
561995|NCT00610714|P1|Participant Flow|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
561996|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
562037|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562038|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562039|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
561997|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
561998|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
561999|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
562000|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
562001|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
562002|NCT00610714|E2|Reported Event|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
562003|NCT00610714|E1|Reported Event|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
562004|NCT00610701|B3|Baseline|Total|Total of all reporting groups
562005|NCT00610701|B2|Baseline|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
562006|NCT00610701|B1|Baseline|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
562007|NCT00610701|P2|Participant Flow|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
562008|NCT00610701|P1|Participant Flow|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
562009|NCT00610701|O2|Outcome|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
562010|NCT00610701|O1|Outcome|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
562011|NCT00610701|E2|Reported Event|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
562012|NCT00610701|E1|Reported Event|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
562013|NCT00610688|B4|Baseline|Total|Total of all reporting groups
562014|NCT00610688|B3|Baseline|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
562015|NCT00610688|B2|Baseline|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
562016|NCT00610688|B1|Baseline|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
562017|NCT00610688|P3|Participant Flow|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
562018|NCT00610688|P2|Participant Flow|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
562019|NCT00610688|P1|Participant Flow|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
562020|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
562021|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
562022|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
562023|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
562024|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
562025|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
562026|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
562027|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
562028|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
562029|NCT00610688|E3|Reported Event|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
562030|NCT00610688|E2|Reported Event|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
562031|NCT00610688|E1|Reported Event|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
562032|NCT00610675|B1|Baseline|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562033|NCT00610675|P1|Participant Flow|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562034|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562035|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562036|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562040|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562041|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562042|NCT00610675|E1|Reported Event|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
562043|NCT00610649|B12|Baseline|Total|Total of all reporting groups
562044|NCT00610649|B11|Baseline|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
562045|NCT00610649|B10|Baseline|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
562046|NCT00610649|B9|Baseline|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
562047|NCT00610649|B8|Baseline|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
562048|NCT00610649|B7|Baseline|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
562049|NCT00610649|B6|Baseline|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
562050|NCT00610649|B5|Baseline|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
562051|NCT00610649|B4|Baseline|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
562052|NCT00610649|B3|Baseline|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
562053|NCT00610649|B2|Baseline|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
562054|NCT00610649|B1|Baseline|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
562055|NCT00610649|P11|Participant Flow|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
562056|NCT00610649|P10|Participant Flow|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
562057|NCT00610649|P9|Participant Flow|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days.
562058|NCT00610649|P8|Participant Flow|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
562059|NCT00610649|P7|Participant Flow|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
562060|NCT00610649|P6|Participant Flow|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
562061|NCT00610649|P5|Participant Flow|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
562062|NCT00610649|P4|Participant Flow|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
562063|NCT00610649|P3|Participant Flow|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
562064|NCT00610649|P2|Participant Flow|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
562065|NCT00610649|P1|Participant Flow|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
562066|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
562067|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
562068|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
562069|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
562070|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
562071|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
562072|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
562073|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
562074|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
562075|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
562076|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
562077|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
562078|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
562079|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
562080|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
562081|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
562082|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
562083|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
562084|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
562085|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
562086|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
562087|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
562088|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
562089|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
562090|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
562091|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
562092|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
562093|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
562094|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
562095|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
562096|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
562097|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
562098|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
562099|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
562100|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
562101|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
562102|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
562103|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
562104|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
562105|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
562106|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
562107|NCT00610649|E11|Reported Event|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
562108|NCT00610649|E10|Reported Event|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
562109|NCT00610649|E9|Reported Event|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
562110|NCT00610649|E8|Reported Event|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
562111|NCT00610649|E7|Reported Event|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
562112|NCT00610649|E6|Reported Event|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
562113|NCT00610649|E5|Reported Event|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
562114|NCT00610649|E4|Reported Event|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
562115|NCT00610649|E3|Reported Event|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
562116|NCT00610649|E2|Reported Event|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
562117|NCT00610649|E1|Reported Event|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
562118|NCT00610532|B1|Baseline|All Study Participants|All study participants progressed from intravenous phenytoin alone to intravenous phenytoin plus probenecid
562119|NCT00610532|P1|Participant Flow|All Study Participants|All study participants progressed from receiving intravenous phenytoin alone to intravenous phenytoin plus probenecid.
562120|NCT00610532|O2|Outcome|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
562121|NCT00610532|O1|Outcome|Intravenous Phenytoin Alone|intravenous phenytoin alone
562122|NCT00610532|E2|Reported Event|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
562123|NCT00610532|E1|Reported Event|Intravenous Phenytoin Alone|intravenous phenytoin alone
562124|NCT00610441|B5|Baseline|Total|Total of all reporting groups
562125|NCT00610441|B4|Baseline|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
562126|NCT00610441|B3|Baseline|MK-8777 RD→PBO|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
562127|NCT00610441|B2|Baseline|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
562128|NCT00610441|B1|Baseline|MK-8777 FD→PBO|Participants receive a fixed dose FD of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
562129|NCT00610441|P4|Participant Flow|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
562130|NCT00610441|P3|Participant Flow|MK-8777 RD→PBO|Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
562131|NCT00610441|P2|Participant Flow|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
562132|NCT00610441|P1|Participant Flow|MK-8777 FD→PBO|Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
562133|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562134|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562135|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562136|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562137|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562138|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562139|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562140|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562141|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562142|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562143|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562144|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562145|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562146|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562147|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562148|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562149|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562150|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562151|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562152|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562153|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562154|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562155|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562156|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562157|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562158|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562430|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562159|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562160|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562161|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562162|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562163|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562164|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562165|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562166|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562167|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562168|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562169|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562170|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562171|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562172|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562173|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562174|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562175|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562176|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562177|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562178|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562179|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562180|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562181|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562182|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562183|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562184|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562185|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562186|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562187|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562188|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562189|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562190|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562191|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562192|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562193|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562194|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562195|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562196|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562197|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562431|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562198|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562199|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562200|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562201|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
562202|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
562203|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
562204|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
562205|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
562206|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
562207|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562208|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562209|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562210|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562211|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562212|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562213|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562214|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562215|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
562216|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562217|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
562218|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
562219|NCT00610441|E3|Reported Event|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for up to 3 weeks.
562220|NCT00610441|E2|Reported Event|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for up to 3 weeks.
562221|NCT00610441|E1|Reported Event|Placebo|Participants receive placebo BID for up to 5 weeks.
562222|NCT00610428|B4|Baseline|Total|Total of all reporting groups
562223|NCT00610428|B3|Baseline|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
562224|NCT00610428|B2|Baseline|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
562225|NCT00610428|B1|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
562226|NCT00610428|P3|Participant Flow|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
562227|NCT00610428|P2|Participant Flow|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
562228|NCT00610428|P1|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
562229|NCT00610428|O3|Outcome|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
562230|NCT00610428|O2|Outcome|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
562231|NCT00610428|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
562232|NCT00610428|O3|Outcome|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
562233|NCT00610428|O2|Outcome|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
562234|NCT00610428|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
562235|NCT00610428|E3|Reported Event|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Staccato Prochlorperazine 10 mg: Inhaled Prochlorperazine10 mg"
562236|NCT00610428|E2|Reported Event|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Staccato Prochlorperazine 5 mg: Inhaled Prochlorperazine 5 mg"
562237|NCT00610428|E1|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo~Staccato Placebo: Inhaled Staccato Placebo"
562238|NCT00610363|B3|Baseline|Total|Total of all reporting groups
562239|NCT00610363|B2|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562240|NCT00610363|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562241|NCT00610363|P2|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562242|NCT00610363|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 16.
562604|NCT00609362|B3|Baseline|Total|Total of all reporting groups
562243|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562244|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562245|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562246|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562247|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562248|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562249|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562250|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562251|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562252|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562253|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562254|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562255|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562256|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562257|NCT00610363|E2|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
562258|NCT00610363|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
562259|NCT00610311|B1|Baseline|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
562260|NCT00610311|P1|Participant Flow|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
562261|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
562262|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
562263|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
562264|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
562265|NCT00610311|E1|Reported Event|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
562266|NCT00610207|B1|Baseline|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
562267|NCT00610207|P1|Participant Flow|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
562268|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
562269|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
562270|NCT00610207|E1|Reported Event|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
562271|NCT00610168|B3|Baseline|Total|Total of all reporting groups
562272|NCT00610168|B2|Baseline|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562273|NCT00610168|B1|Baseline|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562274|NCT00610168|P2|Participant Flow|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562275|NCT00610168|P1|Participant Flow|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562276|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
562277|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
562278|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
562279|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
562280|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562281|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562282|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562283|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562284|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562285|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562316|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562286|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562287|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562288|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562289|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562290|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562291|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
562292|NCT00610168|E1|Reported Event|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
562293|NCT00610155|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
562294|NCT00610155|P6|Participant Flow|Tramadol Then Pregabalin Then Placebo|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
562295|NCT00610155|P5|Participant Flow|Placebo Then Tramadol Then Pregabalin|Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
562296|NCT00610155|P4|Participant Flow|Pregabalin Then Placebo Then Tramadol|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
562297|NCT00610155|P3|Participant Flow|Placebo Then Pregabalin Then Tramadol|Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
562298|NCT00610155|P2|Participant Flow|Tramadol Then Placebo Then Pregabalin|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
562299|NCT00610155|P1|Participant Flow|Pregabalin Then Tramadol Then Placebo|Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
562300|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562301|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562302|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562303|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562304|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562305|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562306|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562307|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562308|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562309|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562310|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562311|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562312|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562313|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562314|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562315|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562317|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562318|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562319|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562320|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562321|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562322|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562323|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562324|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562325|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562326|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562327|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562328|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562329|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562330|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562331|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562332|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562333|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562334|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562335|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562336|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562337|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562338|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562339|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562340|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562341|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562342|NCT00610155|E3|Reported Event|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
562343|NCT00610155|E2|Reported Event|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
562344|NCT00610155|E1|Reported Event|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
562345|NCT00610129|B1|Baseline|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
562346|NCT00610129|P1|Participant Flow|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
562347|NCT00610129|O1|Outcome|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
562348|NCT00610129|E1|Reported Event|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
562349|NCT00609986|B3|Baseline|Total|Total of all reporting groups
562350|NCT00609986|B2|Baseline|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
562351|NCT00609986|B1|Baseline|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
562352|NCT00609986|P2|Participant Flow|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
562353|NCT00609986|P1|Participant Flow|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
562354|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
562355|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
562356|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
562357|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
562358|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
562359|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
562360|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
562361|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
562362|NCT00609986|E2|Reported Event|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
562363|NCT00609986|E1|Reported Event|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
562364|NCT00609973|B3|Baseline|Total|Total of all reporting groups
562365|NCT00609973|B2|Baseline|Placebo|Placebo bid
562366|NCT00609973|B1|Baseline|Cipro|Ciprofloxacin 500 mg bid
562367|NCT00609973|P2|Participant Flow|Placebo|Placebo bid
562368|NCT00609973|P1|Participant Flow|Cipro|Ciprofloxacin 500 mg bid
562369|NCT00609973|O2|Outcome|Placebo|Placebo bid
562370|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
562371|NCT00609973|O2|Outcome|Placebo|Placebo bid
562372|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
562373|NCT00609973|E2|Reported Event|Placebo|Placebo bid
562374|NCT00609973|E1|Reported Event|Cipro|Ciprofloxacin 500 mg bid
562375|NCT00609947|B1|Baseline|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
562376|NCT00609947|P1|Participant Flow|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
562377|NCT00609947|O1|Outcome|Primary Analysis Endpoint|
562378|NCT00609947|O1|Outcome|Primary Effectiveness Analysis Endpoint - SVS|The 8-month in-segment diameter stenosis from Endeavor Small Vessel Study (SVS) subects
562379|NCT00609947|E1|Reported Event|Primary Analysis Endpoint|"The first 97 subjects enrolled and implanted with 2.25mm stents~The first 39 subjects enrolled and implanted with 2.5mm stents~The first 40 subjects enrolled and implanted with 2.75mm stents~A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"
562380|NCT00609869|B1|Baseline|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
562381|NCT00609869|P1|Participant Flow|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
562382|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
562383|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
562384|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
562385|NCT00609869|E1|Reported Event|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
562386|NCT00609804|B3|Baseline|Total|Total of all reporting groups
562387|NCT00609804|B2|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562388|NCT00609804|B1|Baseline|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562389|NCT00609804|P2|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562390|NCT00609804|P1|Participant Flow|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562391|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562392|NCT00609804|O1|Outcome|Sorafenib and Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562393|NCT00609804|O2|Outcome|Sorafenib|Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562394|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562395|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562396|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562397|NCT00609804|E2|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562398|NCT00609804|E1|Reported Event|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
562399|NCT00609765|B1|Baseline|Chemotherapy|Prospective, single arm, Phase II
562400|NCT00609765|P1|Participant Flow|Chemotherapy|Prospective, single arm, Phase II
562401|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
562402|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
562403|NCT00609765|E1|Reported Event|Chemotherapy|Prospective, single arm, Phase II
562404|NCT00609739|B1|Baseline|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
562405|NCT00609739|P1|Participant Flow|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
562406|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
562407|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
562408|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
562409|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
562410|NCT00609739|E1|Reported Event|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
562411|NCT00609674|B3|Baseline|Total|Total of all reporting groups
562412|NCT00609674|B2|Baseline|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562413|NCT00609674|B1|Baseline|Placebo|Placebo nasal spray
562414|NCT00609674|P2|Participant Flow|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562415|NCT00609674|P1|Participant Flow|Placebo|Placebo nasal spray
562416|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562417|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562418|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562419|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562420|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562421|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562422|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562423|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562424|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562425|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562426|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562427|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562428|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562429|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562432|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562433|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562434|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562435|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562436|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562437|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562438|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562439|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562440|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562441|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562442|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562443|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562444|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562445|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
562446|NCT00609674|E2|Reported Event|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
562447|NCT00609674|E1|Reported Event|Placebo|Placebo nasal spray
562448|NCT00609622|B3|Baseline|Total|Total of all reporting groups
562449|NCT00609622|B2|Baseline|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562450|NCT00609622|B1|Baseline|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562451|NCT00609622|P2|Participant Flow|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kilogram (mg/kg) administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and a 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562452|NCT00609622|P1|Participant Flow|Sunitinib + mFOLFOX6|Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (5-FU) 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562453|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562454|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562455|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562456|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562457|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562458|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562459|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562460|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562605|NCT00609362|B2|Baseline|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
562461|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562462|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562463|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562464|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562465|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562466|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562467|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562468|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562469|NCT00609622|E2|Reported Event|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562470|NCT00609622|E1|Reported Event|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
562471|NCT00609518|B3|Baseline|Total|Total of all reporting groups
562472|NCT00609518|B2|Baseline|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
562473|NCT00609518|B1|Baseline|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
562474|NCT00609518|P2|Participant Flow|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
562475|NCT00609518|P1|Participant Flow|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
562476|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
562477|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
562478|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
562479|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
562480|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
562606|NCT00609362|B1|Baseline|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
562481|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
562482|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
562483|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
562484|NCT00609518|E2|Reported Event|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
562485|NCT00609518|E1|Reported Event|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
562486|NCT00609492|B4|Baseline|Total|Total of all reporting groups
562487|NCT00609492|B3|Baseline|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562488|NCT00609492|B2|Baseline|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562489|NCT00609492|B1|Baseline|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562490|NCT00609492|P3|Participant Flow|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562491|NCT00609492|P2|Participant Flow|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562492|NCT00609492|P1|Participant Flow|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562493|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562494|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562495|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562496|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562497|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562498|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562607|NCT00609362|P2|Participant Flow|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
562608|NCT00609362|P1|Participant Flow|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
562609|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
562499|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562500|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562501|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562502|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562503|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid
562504|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562505|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562506|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562507|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562508|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562509|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562510|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562511|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562512|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562513|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562514|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562610|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
562515|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562516|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562517|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562518|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562519|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562520|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562521|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562522|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562523|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562524|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562525|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562526|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562527|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562528|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562529|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562530|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562611|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
562531|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562532|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562533|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562534|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562535|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562536|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562537|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562538|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562539|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562540|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562541|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562542|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562543|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562544|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562545|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562546|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562612|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
562547|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562548|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562549|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562550|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562551|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562552|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562553|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562554|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562555|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562556|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562557|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562558|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562559|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562560|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562561|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562562|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562613|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
562563|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562564|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562565|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562566|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562567|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562568|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562569|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562570|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562571|NCT00609492|E2|Reported Event|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562572|NCT00609492|E1|Reported Event|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
562573|NCT00609466|B4|Baseline|Total|Total of all reporting groups
562574|NCT00609466|B3|Baseline|Placebo|Matching Placebo 4 to 6 hourly
562575|NCT00609466|B2|Baseline|Morphine|Morphine IR 30mg 4 to 6 hourly
562576|NCT00609466|B1|Baseline|CG5503|CG5503 IR 75mg 4-6 hourly
562577|NCT00609466|P3|Participant Flow|Placebo|Matching Placebo 4 to 6 hourly
562578|NCT00609466|P2|Participant Flow|Morphine|Morphine IR 30mg 4 to 6 hourly
562579|NCT00609466|P1|Participant Flow|CG5503|CG5503 IR 75mg 4-6 hourly
562580|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
562581|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
562582|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
562583|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
562584|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
562585|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
562586|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
562587|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
562588|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
562589|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
562590|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
562591|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
562592|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
562593|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
562594|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
562595|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
562596|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
562597|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
562598|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
562599|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
562600|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
562601|NCT00609466|E3|Reported Event|Placebo|Matching Placebo 4 to 6 hourly
562602|NCT00609466|E2|Reported Event|Morphine|Morphine IR 30mg 4 to 6 hourly
562603|NCT00609466|E1|Reported Event|CG5503|CG5503 IR 75mg 4-6 hourly
562614|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
562615|NCT00609362|E2|Reported Event|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
562616|NCT00609362|E1|Reported Event|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
562617|NCT00609336|B1|Baseline|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562618|NCT00609336|P1|Participant Flow|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~gemcitabine: Given IV~oxaliplatin: Given IV"
562619|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~gemcitabine: Given IV~oxaliplatin: Given IV"
562620|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562621|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562622|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562623|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562624|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562625|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562626|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562627|NCT00609336|O1|Outcome|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~laboratory biomarker analysis: Correlative studies"
562628|NCT00609336|E1|Reported Event|Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)|"See Detailed Description~gemcitabine hydrochloride: Given IV~docetaxel: Given IV~capecitabine: Given PO~intensity-modulated radiation therapy: Undergo IMRT~oxaliplatin: Given IV~pancreatic surgical procedure: Undergo pancreaticoduodenectomy~therapeutic conventional surgery: Undergo therapeutic conventional surgery~gemcitabine: Given IV~oxaliplatin: Given IV"
562629|NCT00609245|B1|Baseline|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.~Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
562630|NCT00609245|P1|Participant Flow|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.~Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
562631|NCT00609245|O2|Outcome|Valproic Acid|The investigators will utilize intravenous sodium valproate. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
562632|NCT00609245|O1|Outcome|Placebo|Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration.
562633|NCT00609245|E2|Reported Event|Placebo|placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
562814|NCT00608777|E1|Reported Event|Open Label|
562815|NCT00608634|B4|Baseline|Total|Total of all reporting groups
562634|NCT00609245|E1|Reported Event|Valproic Acid|Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
562635|NCT00609167|B3|Baseline|Total|Total of all reporting groups
562636|NCT00609167|B2|Baseline|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562637|NCT00609167|B1|Baseline|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562638|NCT00609167|P2|Participant Flow|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562639|NCT00609167|P1|Participant Flow|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562640|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562641|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562642|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562643|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562644|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562645|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562646|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562647|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562648|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562649|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562650|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562651|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562652|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562653|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562654|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562655|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562656|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
562657|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
562658|NCT00609167|E2|Reported Event|CyBorD (Bortezomib 1.5mg/m^2)|Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
562659|NCT00609167|E1|Reported Event|CyBorD (Bortezomib 1.3mg/m^2)|Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
562660|NCT00608985|B5|Baseline|Total|Total of all reporting groups
562661|NCT00608985|B4|Baseline|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562662|NCT00608985|B3|Baseline|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562663|NCT00608985|B2|Baseline|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562664|NCT00608985|B1|Baseline|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562665|NCT00608985|P4|Participant Flow|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562666|NCT00608985|P3|Participant Flow|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562816|NCT00608634|B3|Baseline|Arm III|Patients apply POH cream (0.76%) as in arm II.
562667|NCT00608985|P2|Participant Flow|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562668|NCT00608985|P1|Participant Flow|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562669|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562670|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562671|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562672|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562673|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562674|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562675|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562676|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562677|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562678|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562679|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562680|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562681|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562682|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562683|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562684|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562685|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562686|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562687|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562688|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562689|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562690|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562691|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562692|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562693|NCT00608985|E4|Reported Event|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
562694|NCT00608985|E3|Reported Event|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
562695|NCT00608985|E2|Reported Event|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
562696|NCT00608985|E1|Reported Event|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
562697|NCT00608959|B3|Baseline|Total|Total of all reporting groups
562698|NCT00608959|B2|Baseline|Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1)|25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1.
562699|NCT00608959|B1|Baseline|Omiganan 1% Gel (Part 2)|25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2.
562700|NCT00608959|P1|Participant Flow|Omiganan 1% Gel and Chlorhexidine|"In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen and chlorhexidine applied to 6 matching sites on the contralateral side.Swab cultures were taken at specified timepoints over 72 hours.~In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Swab cultures were taken at specified timepoints over 7 days.In addition subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period."
562701|NCT00608959|O2|Outcome|Chlorhexidine 2%/ Isopropyl Alcohol|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with chlorhexidine/isopropyl alcohol prior to catheter insertion.Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
562702|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
562703|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 7 days.
562704|NCT00608959|O2|Outcome|Chlorhexidine 2%(Part 1)|Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days.
562705|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
562706|NCT00608959|E3|Reported Event|Omiganan 1% (Part 2)|In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Omiganan 1% gel was applied to one intravenous (IV) catheter site.
562707|NCT00608959|E2|Reported Event|Chlorhexidine|In Part 1 each subject had chlorhexidine 2% applied to 6 sites located across the chest and/or abdomen. In Part 2 subjects had chlorhexidine 2%/isopropyl alcohol applied to one intravenous (IV) catheter site.
562708|NCT00608959|E1|Reported Event|Omiganan 1% Gel (Part 1)|In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen.
562709|NCT00608907|B4|Baseline|Total|Total of all reporting groups
562710|NCT00608907|B3|Baseline|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
562711|NCT00608907|B2|Baseline|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
562712|NCT00608907|B1|Baseline|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
562713|NCT00608907|P3|Participant Flow|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
562714|NCT00608907|P2|Participant Flow|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
562715|NCT00608907|P1|Participant Flow|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
562716|NCT00608907|O3|Outcome|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
562717|NCT00608907|O2|Outcome|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
562718|NCT00608907|O1|Outcome|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
562719|NCT00608907|E3|Reported Event|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
562720|NCT00608907|E2|Reported Event|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
562721|NCT00608907|E1|Reported Event|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
562722|NCT00608881|B3|Baseline|Total|Total of all reporting groups
562723|NCT00608881|B2|Baseline|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562724|NCT00608881|B1|Baseline|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562725|NCT00608881|P2|Participant Flow|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562726|NCT00608881|P1|Participant Flow|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562727|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562728|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562729|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562730|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562731|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562732|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562733|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562734|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562735|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562736|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562737|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562738|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562739|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562740|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562741|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562742|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562743|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562744|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562745|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562746|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562747|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562748|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562749|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562750|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562751|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562752|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562753|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562754|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562755|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562756|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562757|NCT00608881|E2|Reported Event|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
562758|NCT00608881|E1|Reported Event|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
562759|NCT00608868|B1|Baseline|Gefitinib|gefitinib tablet 250 mg orally
562760|NCT00608868|P1|Participant Flow|Gefitinib|gefitinib tablet 250 mg orally
562761|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
562762|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
562763|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
562764|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
562765|NCT00608868|E1|Reported Event|Gefitinib|gefitinib tablet 250 mg orally
562766|NCT00608842|B5|Baseline|Total|Total of all reporting groups
562767|NCT00608842|B4|Baseline|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562768|NCT00608842|B3|Baseline|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562769|NCT00608842|B2|Baseline|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562770|NCT00608842|B1|Baseline|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562771|NCT00608842|P4|Participant Flow|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562772|NCT00608842|P3|Participant Flow|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562773|NCT00608842|P2|Participant Flow|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562774|NCT00608842|P1|Participant Flow|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562775|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562776|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562777|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562778|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562779|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562780|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562781|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562782|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562783|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562784|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562977|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562785|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562786|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562787|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562788|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562789|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562790|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562791|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562792|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562793|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562794|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562795|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562796|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562797|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562798|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562799|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562800|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562801|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562802|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562803|NCT00608842|E4|Reported Event|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562804|NCT00608842|E3|Reported Event|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562805|NCT00608842|E2|Reported Event|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562806|NCT00608842|E1|Reported Event|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
562807|NCT00608829|B1|Baseline|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
562808|NCT00608829|P1|Participant Flow|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
562809|NCT00608829|O1|Outcome|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
562810|NCT00608829|E1|Reported Event|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
562811|NCT00608777|B1|Baseline|Open Label Taclonex|
562812|NCT00608777|P1|Participant Flow|Open Label Taclonex|
562813|NCT00608777|O1|Outcome|Open Label Taclonex|
562817|NCT00608634|B2|Baseline|Arm II|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562818|NCT00608634|B1|Baseline|Arm I|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562819|NCT00608634|P3|Participant Flow|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
562820|NCT00608634|P2|Participant Flow|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562821|NCT00608634|P1|Participant Flow|Placbeo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562822|NCT00608634|O3|Outcome|High Dose 0.76% POH|Patients apply POH cream (0.76%) as in arm II.
562823|NCT00608634|O2|Outcome|Low Dose 0.30% POH|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562824|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562825|NCT00608634|O3|Outcome|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
562826|NCT00608634|O2|Outcome|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562827|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562828|NCT00608634|E3|Reported Event|High Dose POH 0.76%|Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562829|NCT00608634|E2|Reported Event|Low Dose POH 0.3%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562830|NCT00608634|E1|Reported Event|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
562831|NCT00608582|B3|Baseline|Total|Total of all reporting groups
562832|NCT00608582|B2|Baseline|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562833|NCT00608582|B1|Baseline|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562834|NCT00608582|P2|Participant Flow|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562835|NCT00608582|P1|Participant Flow|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562836|NCT00608582|O2|Outcome|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562837|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562838|NCT00608582|O2|Outcome|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
562869|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
562978|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562839|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562840|NCT00608582|E2|Reported Event|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
562841|NCT00608582|E1|Reported Event|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
562842|NCT00608569|B3|Baseline|Total|Total of all reporting groups
562843|NCT00608569|B2|Baseline|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562844|NCT00608569|B1|Baseline|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562845|NCT00608569|P2|Participant Flow|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562846|NCT00608569|P1|Participant Flow|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562847|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562848|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562849|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562850|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562851|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562852|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562853|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562854|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562855|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562856|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562857|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562858|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562859|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562860|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562861|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562862|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562863|NCT00608569|E2|Reported Event|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
562864|NCT00608569|E1|Reported Event|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
562865|NCT00608543|B1|Baseline|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
562866|NCT00608543|P1|Participant Flow|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
562867|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
562868|NCT00608543|O1|Outcome|Spatial Working Memory Between Errors for 6-move Problems|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
562870|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
562871|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
562872|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
562873|NCT00608543|E1|Reported Event|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
562874|NCT00608530|B5|Baseline|Total|Total of all reporting groups
562875|NCT00608530|B4|Baseline|Supportive Psychotherapy-Nurse-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact by a medical nurse~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
562876|NCT00608530|B3|Baseline|Cognitive Behavioral Therapy-Nurse-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact by a medical nurse~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
562877|NCT00608530|B2|Baseline|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact by a psychologist~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
562878|NCT00608530|B1|Baseline|Cognitive Behavioral Therapy-Psychologist-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact by a psychologist~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
562879|NCT00608530|P4|Participant Flow|Supportive Psychotherapy-Nurse-Delivered|10 hours of Supportive Psychotherapy delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
562880|NCT00608530|P3|Participant Flow|Cognitive Behavioral Therapy-Nurse-Delivered|"10 hours of Cognitive Behavioral Training delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
562881|NCT00608530|P2|Participant Flow|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Supportive Psychotherapy delivered by a psychologist over 8 weeks by telephone and face-to-face contact~Rogerian supportive psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach"
562882|NCT00608530|P1|Participant Flow|Cognitive Behavioral Therapy-Psychologist-Dellivered|"10 hours of Cognitive Behavioral Training delivered by a psychologist over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
562883|NCT00608530|O2|Outcome|Supportive Psychotherapy Nurse-Delivered Treatment Study|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
562884|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy Nurse-Delivered Treatment Study|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
562885|NCT00608530|O2|Outcome|Supportive Care-Psychologist-Delivered|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks by a psychologist
562886|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy-Psychologist Delivered|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks by a psychologist
562887|NCT00608530|O2|Outcome|Supportive Psychotherapy Nurse-Delivered Treatment Study|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
562888|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy Nurse-Delivered Treatment Study|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
562889|NCT00608530|O2|Outcome|Supportive Care Psychologist-Delivered|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks by a psychologist
562890|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy-Psychologist Delivered|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks by a psychologist
562891|NCT00608530|O2|Outcome|Supportive Psychotherapy Nurse-Delivered Treatment Study|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
562892|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy Nurse-Delivered Treatment Study|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
562893|NCT00608530|O2|Outcome|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
562894|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy Psychol-Delivered Treatment Study|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specific goals for functioning (e.g., walking 30 minutes daily)."
562895|NCT00608530|E4|Reported Event|Supportive Psychotherapy Nurse-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapists encourage individuals to identify goals and solutions using a supportive, reflective, empathic approach rather than a directive or prescriptive approach"
562922|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562896|NCT00608530|E3|Reported Event|Cognitive Behavioral Therapy-Nurse-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
562897|NCT00608530|E2|Reported Event|Supportive Psychotherapy-Psychologist-Delivered|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapists encourage individuals to identify goals and solutions using a supportive, reflective, empathic approach rather than a directive or prescriptive approach"
562898|NCT00608530|E1|Reported Event|Cognitive Behavioral Therapy-Psychologist-Delivered|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
562899|NCT00608517|B4|Baseline|Total|Total of all reporting groups
562900|NCT00608517|B3|Baseline|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562901|NCT00608517|B2|Baseline|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562902|NCT00608517|B1|Baseline|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562903|NCT00608517|P3|Participant Flow|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562904|NCT00608517|P2|Participant Flow|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562905|NCT00608517|P1|Participant Flow|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562906|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562907|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562908|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562909|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562910|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562911|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562912|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562913|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562914|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562915|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562916|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562917|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562918|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562919|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562920|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562921|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562976|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562923|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours
562924|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562925|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562926|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562927|NCT00608517|E3|Reported Event|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
562928|NCT00608517|E2|Reported Event|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
562929|NCT00608517|E1|Reported Event|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
562930|NCT00608491|B3|Baseline|Total|Total of all reporting groups
562931|NCT00608491|B2|Baseline|Ultrafiltration|Participants will receive ultrafiltration
562932|NCT00608491|B1|Baseline|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562933|NCT00608491|P2|Participant Flow|Ultrafiltration|Participants will receive ultrafiltration
562934|NCT00608491|P1|Participant Flow|Stepped Pharmacologic Care|Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes
562935|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562936|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562937|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562938|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562939|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562940|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562941|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562942|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562943|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562944|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562945|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562946|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562947|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562948|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562949|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562950|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562951|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562952|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562953|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562954|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562955|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562956|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562957|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562958|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562959|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562960|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562961|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562962|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562963|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562964|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562965|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562966|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562967|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562968|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562969|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562970|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562971|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562972|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562973|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562974|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562975|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562979|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562980|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562981|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562982|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562983|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562984|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562985|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562986|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562987|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562988|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562989|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562990|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562991|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562992|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562993|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562994|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562995|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562996|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562997|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
562998|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
562999|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563000|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563001|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563002|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563003|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563004|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563005|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563006|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563007|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563008|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563009|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563010|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563011|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563012|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563013|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563014|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563015|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563016|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563017|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563018|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563019|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563020|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563021|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563022|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563023|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563024|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563025|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563026|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563027|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563028|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563029|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563030|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563031|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563032|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563033|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563034|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563035|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563036|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563037|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563038|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563039|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563040|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563041|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563042|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563043|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563044|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563045|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563046|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563047|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563048|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563049|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563050|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563051|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563052|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563053|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563054|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563055|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563056|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563057|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563058|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563059|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563060|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563061|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563062|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563063|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563064|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563065|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563066|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563067|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563068|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563069|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563070|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563071|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563072|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563073|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
563074|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563075|NCT00608491|E2|Reported Event|Ultrafiltration|Participants will receive ultrafiltration
563076|NCT00608491|E1|Reported Event|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
563077|NCT00608465|B1|Baseline|All Patients|The study was never unblinded as enrollment was never completed.
563078|NCT00608465|P1|Participant Flow|All Patients|The study was never unblinded as enrollment was never completed.
563079|NCT00608465|O1|Outcome|All Patients|The study was never unblinded as enrollment was never completed.
563080|NCT00608465|O1|Outcome|All Patients|The study was never unblinded as enrollment was never completed.
563081|NCT00608465|E1|Reported Event|All Patients|The study was never unblinded as enrollment was never completed.
563082|NCT00608426|B3|Baseline|Total|Total of all reporting groups
563083|NCT00608426|B2|Baseline|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
563084|NCT00608426|B1|Baseline|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
563085|NCT00608426|P2|Participant Flow|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
563086|NCT00608426|P1|Participant Flow|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
563087|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
563088|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
563089|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
563090|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
563124|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563091|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
563092|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
563093|NCT00608426|E2|Reported Event|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
563094|NCT00608426|E1|Reported Event|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
563095|NCT00608322|B3|Baseline|Total|Total of all reporting groups
563096|NCT00608322|B2|Baseline|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
563097|NCT00608322|B1|Baseline|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
563098|NCT00608322|P2|Participant Flow|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
563099|NCT00608322|P1|Participant Flow|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
563100|NCT00608322|O2|Outcome|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
563101|NCT00608322|O1|Outcome|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
563102|NCT00608322|E2|Reported Event|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
563103|NCT00608322|E1|Reported Event|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
563104|NCT00608244|B1|Baseline|LCP-Tacro|Evaluation of steady state tacrolimus exposure (AUC0-24) and trough levels (C24) in stable liver transplant recipients converted from Prograf to LCP-Tacro in a 3-sequence study design and validate the dose conversion ratio determined in the Phase 1 program.
563105|NCT00608244|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22, patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL."
563106|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
563107|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
563108|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
563109|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
563110|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
563111|NCT00608244|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with Prograf. Adverse Events occurring during the follow up period (Days 22-51) have been counted in the Prograf treatment arm as patients were on Prograf during this period."
563112|NCT00608244|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with LCP-Tacro."
563113|NCT00608205|B3|Baseline|Total|Total of all reporting groups
563114|NCT00608205|B2|Baseline|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563115|NCT00608205|B1|Baseline|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563116|NCT00608205|P2|Participant Flow|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563117|NCT00608205|P1|Participant Flow|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563118|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563119|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563120|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563121|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563122|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563123|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563241|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
563125|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563126|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563127|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563128|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563129|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563130|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563131|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563132|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563133|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563134|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563135|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563136|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563137|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563138|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563139|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563140|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563141|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563142|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563143|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563144|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563145|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563146|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563147|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563148|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563149|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563150|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563151|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563152|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563153|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563154|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563155|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563156|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563157|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563158|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563159|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563160|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563161|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563162|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563163|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563164|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563165|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563166|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563167|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563168|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563169|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563170|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563171|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563172|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563173|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563174|NCT00608205|O2|Outcome|Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563175|NCT00608205|O1|Outcome|Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563176|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563177|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563178|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563179|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563180|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563181|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563182|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563183|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563184|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563185|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563186|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563187|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563188|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563189|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563190|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563191|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563192|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563193|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563194|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563195|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563196|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563197|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563198|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563199|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563200|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563201|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563202|NCT00608205|E2|Reported Event|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
563203|NCT00608205|E1|Reported Event|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
563204|NCT00608140|B3|Baseline|Total|Total of all reporting groups
563205|NCT00608140|B2|Baseline|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
563206|NCT00608140|B1|Baseline|1 Medical Therapy Plus Surgical Repair|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
563207|NCT00608140|P2|Participant Flow|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
563208|NCT00608140|P1|Participant Flow|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
563209|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
563210|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
563211|NCT00608140|O3|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563212|NCT00608140|O2|Outcome|Optimal Medical Therapy Alone|"Participants will receive optimal medical therapy alone~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563213|NCT00608140|O1|Outcome|Optimal Medical Therapy Plus Surgical MVR|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563214|NCT00608140|O3|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563215|NCT00608140|O2|Outcome|Optimal Medical Therapy Alone|"Participants will receive optimal medical therapy alone~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563216|NCT00608140|O1|Outcome|Optimal Medical Therapy Plus Surgical MVR|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563242|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
563243|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
563244|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
563217|NCT00608140|O3|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563218|NCT00608140|O2|Outcome|Optimal Medical Therapy Alone|"Participants will receive optimal medical therapy alone~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563219|NCT00608140|O1|Outcome|Optimal Medical Therapy Plus Surgical MVR|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563220|NCT00608140|O3|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for rup"
563221|NCT00608140|O2|Outcome|Optimal Medical Therapy Alone|"Participants will receive optimal medical therapy alone~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563222|NCT00608140|O1|Outcome|Optimal Medical Therapy Plus Surgical MVR|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or signific"
563223|NCT00608140|O3|Outcome|Optimal Medical Therapy Plus 18 Month Delayed MVR|"Participants will receive optimal medical therapy plus 18-month delayed surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering."
563224|NCT00608140|O2|Outcome|Optimal Medical Therapy Alone|"Participants will receive optimal medical therapy alone~Optimal medical therapy (OMT): Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy."
563225|NCT00608140|O1|Outcome|Optimal Medical Therapy Plus Surgical MV Repair|"Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement~Surgical mitral valvuloplasty with placement of annular ring (SMVR): Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering."
563226|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
563227|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
563228|NCT00608140|E2|Reported Event|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
563229|NCT00608140|E1|Reported Event|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
563230|NCT00608023|B4|Baseline|Total|Total of all reporting groups
563231|NCT00608023|B3|Baseline|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
563232|NCT00608023|B2|Baseline|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
563233|NCT00608023|B1|Baseline|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
563234|NCT00608023|P3|Participant Flow|Placebo-Tesamorelin (P-T)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
563235|NCT00608023|P2|Participant Flow|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
563236|NCT00608023|P1|Participant Flow|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 Weeks
563237|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
563238|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
563239|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
563240|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
563245|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
563246|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks.
563247|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks.
563248|NCT00608023|O1|Outcome|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 weeks
563249|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
563250|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
563251|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
563252|NCT00608023|E3|Reported Event|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
563253|NCT00608023|E2|Reported Event|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
563254|NCT00608023|E1|Reported Event|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
563255|NCT00607997|B5|Baseline|Total|Total of all reporting groups
563256|NCT00607997|B4|Baseline|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563257|NCT00607997|B3|Baseline|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563258|NCT00607997|B2|Baseline|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563259|NCT00607997|B1|Baseline|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563260|NCT00607997|P4|Participant Flow|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563261|NCT00607997|P3|Participant Flow|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563262|NCT00607997|P2|Participant Flow|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563263|NCT00607997|P1|Participant Flow|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563264|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563265|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563266|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563267|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563268|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563269|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563270|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563271|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563272|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563273|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563274|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563275|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563276|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563277|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563278|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563279|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563280|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563281|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563430|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
563282|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563283|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563284|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563285|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563286|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563287|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563288|NCT00607997|O5|Outcome|Total|Schedule A, B and C combined
563289|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563290|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563291|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563292|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563293|NCT00607997|O2|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563294|NCT00607997|O1|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563295|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563296|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563297|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563298|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563299|NCT00607997|O5|Outcome|Total|Schedule A, B, and C combined
563300|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563301|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563302|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563303|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563304|NCT00607997|O5|Outcome|Total|Schedule A, B and C combined
563305|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563306|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563307|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563308|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563309|NCT00607997|O5|Outcome|Total|Schedule A, B and C combined
563310|NCT00607997|O4|Outcome|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563311|NCT00607997|O3|Outcome|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563312|NCT00607997|O2|Outcome|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563313|NCT00607997|O1|Outcome|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563314|NCT00607997|E4|Reported Event|Schedule C: 90 mg/m2 on Days 1 and 4|Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
563315|NCT00607997|E3|Reported Event|Schedule C: 72 mg/m2 on Days 1 and 4|Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
563316|NCT00607997|E2|Reported Event|Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8|Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
563431|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
563317|NCT00607997|E1|Reported Event|Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15|The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
563318|NCT00607919|B3|Baseline|Total|Total of all reporting groups
563319|NCT00607919|B2|Baseline|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563320|NCT00607919|B1|Baseline|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563321|NCT00607919|P2|Participant Flow|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563322|NCT00607919|P1|Participant Flow|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563323|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563324|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563325|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563326|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563327|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563328|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563329|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563330|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563331|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563332|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563333|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563388|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563389|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563334|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563335|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563336|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563337|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563338|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563339|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563340|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563341|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563342|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563343|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563344|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563345|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563346|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563347|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563348|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563349|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563428|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
563350|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563351|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563352|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563353|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563354|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563355|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563356|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563357|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563358|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563359|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563360|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563361|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563362|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563363|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563364|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563365|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563366|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563367|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563368|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563369|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563370|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563371|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563372|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563373|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563374|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563375|NCT00607919|E2|Reported Event|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
563376|NCT00607919|E1|Reported Event|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine"
563377|NCT00607893|B3|Baseline|Total|Total of all reporting groups
563378|NCT00607893|B2|Baseline|Sham CPAP|Participants used the Sham CPAP every night for 8 weeks.
563379|NCT00607893|B1|Baseline|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563380|NCT00607893|P2|Participant Flow|Treatment CPAP|"Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.~Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks."
563381|NCT00607893|P1|Participant Flow|Sham CPAP|"Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.~Sham treatment: Participants will use the lower pressure CPAP every night for 8 weeks."
563382|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563383|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563384|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563385|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563386|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563387|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563429|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
563390|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563391|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563392|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563393|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563394|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563395|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563396|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563397|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563398|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563399|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563400|NCT00607893|O2|Outcome|Treatment CPAP|Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.
563401|NCT00607893|O1|Outcome|Sham CPAP|Participants will use the lower pressure CPAP every night for 8 weeks.
563402|NCT00607893|E4|Reported Event|Run-in/Washout Sham CPAP|The initial run-in and washout period for study qualification to document CPAP adherence on Sham CPAP (negligible pressure).
563403|NCT00607893|E3|Reported Event|Run-in/Washout Treatment CPAP|The initial run-in and washout period for study qualification to document CPAP adherence on treatment CPAP.
563404|NCT00607893|E2|Reported Event|Treatment CPAP|"Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.~Continuous Positive Airway Pressure (CPAP): Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks."
563405|NCT00607893|E1|Reported Event|SHAM CPAP|"Participants will receive sham continuous positive airway pressure for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.~Sham CPAP: Participants will use the lower pressure CPAP every night for 8 weeks."
563406|NCT00607880|B3|Baseline|Total|Total of all reporting groups
563407|NCT00607880|B2|Baseline|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
563408|NCT00607880|B1|Baseline|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
563409|NCT00607880|P2|Participant Flow|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
563410|NCT00607880|P1|Participant Flow|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
563411|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
563412|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
563413|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
563414|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
563415|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
563416|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
563417|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
563418|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
563419|NCT00607880|E2|Reported Event|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
563420|NCT00607880|E1|Reported Event|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
563421|NCT00607867|B3|Baseline|Total|Total of all reporting groups
563422|NCT00607867|B2|Baseline|Control Diet|A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat
563423|NCT00607867|B1|Baseline|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.
563424|NCT00607867|P2|Participant Flow|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
563425|NCT00607867|P1|Participant Flow|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
563426|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
563427|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
563642|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563432|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
563433|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
563434|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
563435|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
563436|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
563437|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
563438|NCT00607867|E2|Reported Event|Control Diet|"A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.~Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat"
563439|NCT00607867|E1|Reported Event|LoBAG30 Diet|"A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.~LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat."
563440|NCT00607815|B3|Baseline|Total|Total of all reporting groups
563441|NCT00607815|B2|Baseline|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563442|NCT00607815|B1|Baseline|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
563443|NCT00607815|P2|Participant Flow|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563444|NCT00607815|P1|Participant Flow|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
563445|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563446|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
563447|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563448|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
563449|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563450|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
563451|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563452|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
563643|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563453|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563454|NCT00607815|O1|Outcome|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
563455|NCT00607815|E2|Reported Event|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
563456|NCT00607815|E1|Reported Event|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
563457|NCT00607789|B3|Baseline|Total|Total of all reporting groups
563458|NCT00607789|B2|Baseline|Placebo Group|Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks
563459|NCT00607789|B1|Baseline|Duloxetine Group|Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks
563460|NCT00607789|P2|Participant Flow|Placebo Group|Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
563461|NCT00607789|P1|Participant Flow|Duloxetine Group|30-120 mg/day of duloxetine during a 12-week period
563462|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
563463|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
563464|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
563465|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
563466|NCT00607789|E2|Reported Event|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
563467|NCT00607789|E1|Reported Event|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks.
563468|NCT00607724|B8|Baseline|Total|Total of all reporting groups
563469|NCT00607724|B7|Baseline|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability
563470|NCT00607724|B6|Baseline|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563471|NCT00607724|B5|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563472|NCT00607724|B4|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563473|NCT00607724|B3|Baseline|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563474|NCT00607724|B2|Baseline|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563475|NCT00607724|B1|Baseline|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563476|NCT00607724|P7|Participant Flow|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563477|NCT00607724|P6|Participant Flow|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563478|NCT00607724|P5|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563479|NCT00607724|P4|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563480|NCT00607724|P3|Participant Flow|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563503|NCT00607724|O6|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563481|NCT00607724|P2|Participant Flow|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563482|NCT00607724|P1|Participant Flow|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0), maximum benefit, or intolerability.
563483|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563484|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563485|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563486|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563487|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563488|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563489|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563490|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563491|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563492|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563493|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563494|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563495|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563496|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563497|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563498|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563499|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563500|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563501|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563502|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563607|NCT00607620|B2|Baseline|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563504|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563505|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563506|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563507|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563508|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563509|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563510|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563511|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563512|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563513|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563514|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563515|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563516|NCT00607724|O1|Outcome|All Participants|Included all participants from Stage 1 and Stage 2.
563517|NCT00607724|O1|Outcome|Stage 1: GDC-0449|Included participants with any tumor who received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg, 270 mg and 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, 270 mg and 540 mg orally, continuing until disease progression, maximum benefit, or intolerability.
563518|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563519|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563520|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563521|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563522|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563523|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563524|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563525|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563526|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563640|NCT00607386|P1|Participant Flow|Idursulfase|Open-label treatment with idursulfase
563641|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563527|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563528|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563529|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563530|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563531|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563532|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563533|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563534|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563535|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563536|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563537|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563538|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
563539|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563540|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563541|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563542|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563543|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563544|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563545|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563546|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563547|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563548|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563549|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
563550|NCT00607724|E7|Reported Event|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
563551|NCT00607724|E6|Reported Event|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants with tolerable safety, pharmacokinetic and pharmacodynamic data from Stage 1 received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
563552|NCT00607724|E5|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1 until disease progression, maximum benefit, or intolerability.
563553|NCT00607724|E4|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
563554|NCT00607724|E3|Reported Event|Stage 1: GDC-0449 (540 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
563555|NCT00607724|E2|Reported Event|Stage 1: GDC-0449 (270 mg)|Stage 1: GDC-0449 (270 mg) Participants received single dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
563556|NCT00607724|E1|Reported Event|Stage 1: GDC-0449 (150 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1, thereafter Day 8 received daily until disease progression, maximum benefit, or intolerability.
563557|NCT00607672|B4|Baseline|Total|Total of all reporting groups
563558|NCT00607672|B3|Baseline|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563559|NCT00607672|B2|Baseline|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563560|NCT00607672|B1|Baseline|Placebo|Patients are randomized to placebo prior to surgery
563561|NCT00607672|P3|Participant Flow|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563562|NCT00607672|P2|Participant Flow|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563563|NCT00607672|P1|Participant Flow|Placebo|Patients are randomized to placebo prior to surgery
563564|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
563565|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
563566|NCT00607672|O1|Outcome|Placebo|Placebo group
563567|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
563568|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
563569|NCT00607672|O1|Outcome|Placebo|Placebo group
563570|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
563571|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
563572|NCT00607672|O1|Outcome|Placebo|Placebo group
563573|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563574|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563575|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563576|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563577|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563578|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563579|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563580|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563581|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563582|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563583|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563584|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563585|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563586|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563587|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563588|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563589|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563590|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563591|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563592|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563593|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563594|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
563595|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
563596|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
563597|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
563598|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
563599|NCT00607672|O1|Outcome|Placebo|Placebo group
563600|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
563601|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
563602|NCT00607672|O1|Outcome|Placebo|Placebo group
563603|NCT00607672|E3|Reported Event|Candesartan (ARB)|Angiotensin receptor blocker group
563604|NCT00607672|E2|Reported Event|Ramipril (ACEI)|Angiotensin-converting enzyme group
563605|NCT00607672|E1|Reported Event|Placebo|Placebo group
563606|NCT00607620|B3|Baseline|Total|Total of all reporting groups
563608|NCT00607620|B1|Baseline|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563609|NCT00607620|P2|Participant Flow|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563610|NCT00607620|P1|Participant Flow|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563611|NCT00607620|O2|Outcome|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563612|NCT00607620|O1|Outcome|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563613|NCT00607620|O2|Outcome|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563614|NCT00607620|O1|Outcome|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563615|NCT00607620|O2|Outcome|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563616|NCT00607620|O1|Outcome|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563617|NCT00607620|O2|Outcome|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563618|NCT00607620|O1|Outcome|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563619|NCT00607620|O2|Outcome|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563620|NCT00607620|O1|Outcome|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563621|NCT00607620|E2|Reported Event|Usual Care|Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
563622|NCT00607620|E1|Reported Event|Intervention|"Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate~Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"
563623|NCT00607594|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
563624|NCT00607594|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
563625|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.~saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
563626|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.~saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
563627|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
563628|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
563629|NCT00607594|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.~saracatinib~laboratory biomarker analysis: Correlative studies"
563630|NCT00607477|B3|Baseline|Total|Total of all reporting groups
563631|NCT00607477|B2|Baseline|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
563632|NCT00607477|B1|Baseline|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
563633|NCT00607477|P2|Participant Flow|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
563634|NCT00607477|P1|Participant Flow|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
563635|NCT00607477|O2|Outcome|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
563636|NCT00607477|O1|Outcome|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
563637|NCT00607477|E2|Reported Event|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
563638|NCT00607477|E1|Reported Event|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
563639|NCT00607386|B1|Baseline|Idursulfase|Open-label treatment with idursulfase
563644|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563645|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563646|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563647|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563648|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563649|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563650|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
563651|NCT00607386|E1|Reported Event|Idursulfase|Open-label treatment with idursulfase
563652|NCT00607373|B3|Baseline|Total|Total of all reporting groups
563653|NCT00607373|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563654|NCT00607373|B1|Baseline|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563655|NCT00607373|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563656|NCT00607373|P1|Participant Flow|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563657|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563658|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563659|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563660|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563661|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563662|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563663|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563664|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563665|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563666|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563667|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563668|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563669|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563670|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563671|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563672|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563673|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563674|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563675|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563676|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563677|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563678|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563679|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563680|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563681|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563682|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563683|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563684|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563685|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563686|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563687|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563688|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563689|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563690|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563691|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563692|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563693|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563694|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563695|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
563696|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563697|NCT00607373|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
564156|NCT00606489|E1|Reported Event|Placebo (250 Milliliters Normal Saline)|
563698|NCT00607373|E1|Reported Event|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
563699|NCT00607321|B1|Baseline|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
563700|NCT00607321|P1|Participant Flow|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
563701|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
563702|NCT00607321|O1|Outcome|Bifurcation Stent System|Evaluable patients within pre-specified follow up window
563703|NCT00607321|O1|Outcome|Bifurcation Stent System|
563704|NCT00607321|O1|Outcome|Bifurcation Stent System|
563705|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
563706|NCT00607321|E1|Reported Event|1. Branch Bifurcation Stent System|All subjects enrolled in the BRANCH study
563707|NCT00607269|B3|Baseline|Total|Total of all reporting groups
563708|NCT00607269|B2|Baseline|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
563709|NCT00607269|B1|Baseline|Control|Control condition receiving minimal incentives for service program attendance and participation.
563710|NCT00607269|P2|Participant Flow|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
563711|NCT00607269|P1|Participant Flow|Control|Control condition receiving minimal incentives for service program attendance and participation.
563712|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
563713|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
563714|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
563715|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
563716|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
563717|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
563718|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
563719|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
563720|NCT00607269|E2|Reported Event|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
563721|NCT00607269|E1|Reported Event|Control|Control condition receiving minimal incentives for service program attendance and participation.
563722|NCT00607243|B3|Baseline|Total|Total of all reporting groups
563723|NCT00607243|B2|Baseline|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
563724|NCT00607243|B1|Baseline|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
563725|NCT00607243|P2|Participant Flow|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
563726|NCT00607243|P1|Participant Flow|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
563727|NCT00607243|O2|Outcome|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
563728|NCT00607243|O1|Outcome|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
563729|NCT00607243|E2|Reported Event|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
563730|NCT00607243|E1|Reported Event|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
563731|NCT00607126|B3|Baseline|Total|Total of all reporting groups
563732|NCT00607126|B2|Baseline|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
563733|NCT00607126|B1|Baseline|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
563734|NCT00607126|P2|Participant Flow|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
563735|NCT00607126|P1|Participant Flow|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
563736|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
563737|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
563738|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
563739|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
563740|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
563741|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
563742|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
563743|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
564189|NCT00606138|B3|Baseline|Total|Total of all reporting groups
563744|NCT00607126|E2|Reported Event|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
563745|NCT00607126|E1|Reported Event|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
563746|NCT00607113|B3|Baseline|Total|Total of all reporting groups
563747|NCT00607113|B2|Baseline|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
563748|NCT00607113|B1|Baseline|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
563749|NCT00607113|P2|Participant Flow|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
563750|NCT00607113|P1|Participant Flow|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
563751|NCT00607113|O2|Outcome|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
563752|NCT00607113|O1|Outcome|Avastin|Cycle 1 (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV) or RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
563753|NCT00607113|E1|Reported Event|Avastin + RAD001|One agent (RAD001 or Avastin) then adding the second agent (Avastin or RAD001): Avastin 15 mg/kg intravenous (IV) every 3 weeks + RAD001 10 mg orally daily for 21 Days
563754|NCT00607087|B4|Baseline|Total|Total of all reporting groups
563755|NCT00607087|B3|Baseline|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
563756|NCT00607087|B2|Baseline|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
563757|NCT00607087|B1|Baseline|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
563758|NCT00607087|P3|Participant Flow|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
563759|NCT00607087|P2|Participant Flow|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
563760|NCT00607087|P1|Participant Flow|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
563761|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563762|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563763|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563764|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563765|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563766|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563767|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563768|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563769|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563770|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563771|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563772|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563773|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563774|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563775|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563776|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563777|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563778|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563779|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563780|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563781|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563782|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563783|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563784|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563785|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563786|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563787|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563788|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563789|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563790|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563791|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563792|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563793|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563794|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563795|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563796|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563797|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563798|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563799|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563800|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563801|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563802|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563803|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563804|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563805|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563806|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563807|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563808|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563809|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563810|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563811|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563812|NCT00607087|E3|Reported Event|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563813|NCT00607087|E2|Reported Event|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563814|NCT00607087|E1|Reported Event|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
563815|NCT00607048|B3|Baseline|Total|Total of all reporting groups
563816|NCT00607048|B2|Baseline|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563817|NCT00607048|B1|Baseline|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563818|NCT00607048|P6|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563819|NCT00607048|P5|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
565114|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
563820|NCT00607048|P4|Participant Flow|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563821|NCT00607048|P3|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563822|NCT00607048|P2|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563823|NCT00607048|P1|Participant Flow|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563824|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563825|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563826|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563827|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563828|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563829|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563830|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563831|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563832|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563833|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563834|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563835|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563836|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563837|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563838|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563839|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563840|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563841|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563842|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563843|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563844|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563845|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563846|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563847|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563848|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563849|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563850|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563851|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563852|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563853|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
565115|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
563854|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563855|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563856|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563857|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563858|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563859|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563860|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563861|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563862|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563863|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563864|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563865|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563866|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563867|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563868|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563869|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563885|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563870|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563871|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563872|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563873|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563874|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563875|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563876|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563877|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563878|NCT00607048|O2|Outcome|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563879|NCT00607048|O1|Outcome|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563880|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563881|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563882|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563883|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563884|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563886|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563887|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563888|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563889|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563890|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563891|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563892|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
563893|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563894|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563895|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
563896|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563897|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563898|NCT00607048|E6|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563899|NCT00607048|E5|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563900|NCT00607048|E4|Reported Event|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
563901|NCT00607048|E3|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
563938|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
563980|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
563902|NCT00607048|E2|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
563903|NCT00607048|E1|Reported Event|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
563904|NCT00606944|B3|Baseline|Total|Total of all reporting groups
563905|NCT00606944|B2|Baseline|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
563906|NCT00606944|B1|Baseline|Control Group|traditional, conventional care group
563907|NCT00606944|P2|Participant Flow|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
563908|NCT00606944|P1|Participant Flow|Control Group|traditional, conventional care group
563909|NCT00606944|O2|Outcome|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
563910|NCT00606944|O1|Outcome|Control Group|traditional, conventional care group
563911|NCT00606944|E2|Reported Event|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
563912|NCT00606944|E1|Reported Event|Control Group|traditional, conventional care group
563913|NCT00606931|B1|Baseline|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
563914|NCT00606931|P1|Participant Flow|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
563915|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
563916|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
563917|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
563918|NCT00606931|E1|Reported Event|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
563919|NCT00606905|B3|Baseline|Total|Total of all reporting groups
563920|NCT00606905|B2|Baseline|Normal Saline|equivalent volume of normal saline
563921|NCT00606905|B1|Baseline|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
563922|NCT00606905|P2|Participant Flow|Normal Saline|equivalent volume of normal saline
563923|NCT00606905|P1|Participant Flow|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
563924|NCT00606905|O2|Outcome|Normal Saline|equivalent volume of normal saline
563925|NCT00606905|O1|Outcome|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
563926|NCT00606905|E2|Reported Event|Normal Saline|equivalent volume of normal saline
563927|NCT00606905|E1|Reported Event|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
563928|NCT00606892|B1|Baseline|Entire Study Population|Includes all subjects who completed the study. (The total number of subjects who were enrolled in both arms of the study.)
563929|NCT00606892|P2|Participant Flow|Varenicline First, Then Placebo|Subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).After a minimum of washout period of 5 days, then subjects received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg).
563930|NCT00606892|P1|Participant Flow|Placebo First, Then Varenicline|Subject received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg). After a minimum washout period of 5 days,then subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).
563931|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
563932|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
563933|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
563934|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the placebo condition.
563935|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the placebo condition.
563936|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the placebo condition.
563937|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
563939|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
563940|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the placebo condition.
563941|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the placebo condition.
563942|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per70kg) infusion under the placebo condition.
563943|NCT00606892|O6|Outcome|Varenicline/ High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the varenicline condition.
563944|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the varenicline condition.
563945|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the varenicline condition.
563946|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the placebo condition.
563947|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the placebo condition.
563948|NCT00606892|O1|Outcome|Placebo/ Low Dose Nictoine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the placebo condition.
563949|NCT00606892|O2|Outcome|Varenicline (1 mg)|The mean cotinine levels for subjects under the varenicline condition.
563950|NCT00606892|O1|Outcome|Placebo|The mean cotinine levels for subjects under the placebo condition.
563951|NCT00606892|O4|Outcome|Varenicline, Post-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition and 30 minutes after the nicotine infusions.
563952|NCT00606892|O3|Outcome|Varenicline, Pre-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition prior to the nicotine infusions.
563953|NCT00606892|O2|Outcome|Placebo, Post-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and 30 minutes after the nicotine infusions.
563954|NCT00606892|O1|Outcome|Placebo, Pre-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and prior to the nicotine infusions.
563955|NCT00606892|E6|Reported Event|Varenicline First, Then Placebo, Second Intervention|Subjects crossed-over from the first intervention (varenicline) and received placebo once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
563956|NCT00606892|E5|Reported Event|Placebo First, Then Varenicline, Second Intervention|Subjects crossed-over from the first intervention and received varenicline once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
563957|NCT00606892|E4|Reported Event|Adaptation - Varenicline First, Then Placebo|Subjects randomized to the 'Varenicline first' condition first received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability before receiving the study medication.
563958|NCT00606892|E3|Reported Event|Adaptation - Placebo First, Then Varenicline|Subjects randomized to the 'Placebo first' condition participated in a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability prior to the study medication intervention.
563959|NCT00606892|E2|Reported Event|Varenicline First, Then Placebo, First Intervention|Subjects received varenicline once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
563960|NCT00606892|E1|Reported Event|Placebo First, Then Varenicline, First Intervention|Subjects received a placebo tablet once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
563961|NCT00606801|B3|Baseline|Total|Total of all reporting groups
563962|NCT00606801|B2|Baseline|Placebo|Placebo given for 10 days.
563963|NCT00606801|B1|Baseline|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
563964|NCT00606801|P2|Participant Flow|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
563965|NCT00606801|P1|Participant Flow|Placebo|Placebo given for 10 days.
563966|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
563967|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
563968|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
563969|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
563970|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
563971|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
563972|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
563973|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
563974|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
563975|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
563976|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
563977|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
563978|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
563979|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
563981|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
563982|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
563983|NCT00606801|O1|Outcome|Placebo - Baseline|Measures prior to medication administration.
563984|NCT00606801|E2|Reported Event|Placebo|Placebo given for 10 days.
563985|NCT00606801|E1|Reported Event|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
563986|NCT00606684|B7|Baseline|Total|Total of all reporting groups
563987|NCT00606684|B6|Baseline|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563988|NCT00606684|B5|Baseline|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563989|NCT00606684|B4|Baseline|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563990|NCT00606684|B3|Baseline|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563991|NCT00606684|B2|Baseline|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563992|NCT00606684|B1|Baseline|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563993|NCT00606684|P7|Participant Flow|GW642444M 50 µg|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563994|NCT00606684|P6|Participant Flow|GW642444M 25 µg|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563995|NCT00606684|P5|Participant Flow|GW642444M 12.5 µg|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563996|NCT00606684|P4|Participant Flow|GW642444M 6.25 µg|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563997|NCT00606684|P3|Participant Flow|GW642444M 3 µg|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563998|NCT00606684|P2|Participant Flow|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
563999|NCT00606684|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning from the novel dual strip dry powder inhaler. In addition, all participants were provided supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used asneeded throughout the study.
564000|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564001|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564002|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564003|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564004|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564005|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564006|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564007|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564008|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564009|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564010|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564011|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564012|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564013|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564014|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564015|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564016|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564017|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564018|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564019|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564020|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564021|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564022|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564023|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564024|NCT00606684|E6|Reported Event|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564025|NCT00606684|E5|Reported Event|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564026|NCT00606684|E4|Reported Event|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564027|NCT00606684|E3|Reported Event|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564028|NCT00606684|E2|Reported Event|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564029|NCT00606684|E1|Reported Event|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
564030|NCT00606632|B1|Baseline|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
564031|NCT00606632|P1|Participant Flow|PET/CT Versus CT|PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
564032|NCT00606632|O4|Outcome|Specificity CT|"Specificity of CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
564033|NCT00606632|O3|Outcome|Specificity PET/CT|"Specificity of PET/CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity of refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
564034|NCT00606632|O2|Outcome|Sensitivity CT|"Sensitivity of diagnostic CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
564035|NCT00606632|O1|Outcome|Sensitivity PET/CT|"Sensitivity of 124I-cG250 PET/CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
564036|NCT00606632|E1|Reported Event|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
564037|NCT00606593|B1|Baseline|Patient Flow|The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.
564038|NCT00606593|P10|Participant Flow|Treatment Sequence 50/100/25/200/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
564039|NCT00606593|P9|Participant Flow|Treatment Sequence 100/200/50/P/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
564040|NCT00606593|P8|Participant Flow|Treatment Sequence 200/P/100/25/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
564041|NCT00606593|P7|Participant Flow|Treatment Sequence P/25/200/50/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
564042|NCT00606593|P6|Participant Flow|Treatment Sequence 25/50/P/100/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
564043|NCT00606593|P5|Participant Flow|Treatment Sequence P/200/25/100/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
564044|NCT00606593|P4|Participant Flow|Treatment Sequence 25/P/50/200/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
564045|NCT00606593|P3|Participant Flow|Treatment Sequence 50/25/100/P/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
564046|NCT00606593|P2|Participant Flow|Treatment Sequence 100/50/200/25/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
564047|NCT00606593|P1|Participant Flow|Treatment Sequence 200/100/P/50/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
564048|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
564049|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
564050|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
564051|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
564052|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
564053|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
564054|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
564055|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
564056|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
564057|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
564058|NCT00606593|E6|Reported Event|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
564059|NCT00606593|E5|Reported Event|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
564060|NCT00606593|E4|Reported Event|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
564061|NCT00606593|E3|Reported Event|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
564062|NCT00606593|E2|Reported Event|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
564063|NCT00606593|E1|Reported Event|Single-blind Placebo|Treatment administered during screening period
564064|NCT00606580|B4|Baseline|Total|Total of all reporting groups
564065|NCT00606580|B3|Baseline|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564066|NCT00606580|B2|Baseline|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564067|NCT00606580|B1|Baseline|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564068|NCT00606580|P3|Participant Flow|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564069|NCT00606580|P2|Participant Flow|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564070|NCT00606580|P1|Participant Flow|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564071|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564072|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564073|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564074|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564075|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564076|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564077|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564078|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564079|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564080|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564081|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564154|NCT00606489|O1|Outcome|Placebo (250 Milliliters Normal Saline)|
564082|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564083|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564084|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564085|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564086|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564087|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564088|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564089|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564090|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564091|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564092|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564093|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564094|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564095|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564096|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564097|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564098|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564099|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564100|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564101|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564102|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564103|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564104|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564155|NCT00606489|E2|Reported Event|800mg Intravenous Ibuprofen|
564105|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564106|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564107|NCT00606580|E3|Reported Event|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
564108|NCT00606580|E2|Reported Event|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
564109|NCT00606580|E1|Reported Event|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
564110|NCT00606554|B3|Baseline|Total|Total of all reporting groups
564111|NCT00606554|B2|Baseline|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564112|NCT00606554|B1|Baseline|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564113|NCT00606554|P2|Participant Flow|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564114|NCT00606554|P1|Participant Flow|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564115|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564116|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564117|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564118|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564119|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564120|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564121|NCT00606554|O2|Outcome|Standard of Care Weaning|Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group
564122|NCT00606554|O1|Outcome|Computer-assisted Weaning|Group assigned to the computer-assisted weaning program. Intervention Group
564123|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564124|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564125|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564126|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564127|NCT00606554|O2|Outcome|Standard of Care Weaning|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Standard of Care weaning: Evidence-based standard of care weaning process."
564128|NCT00606554|O1|Outcome|Computer-assisted Weaning|"Group assigned to the computer-assisted weaning program~Computer-assisted weaning program: Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning."
564129|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564130|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564131|NCT00606554|E2|Reported Event|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
564132|NCT00606554|E1|Reported Event|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
564133|NCT00606502|B3|Baseline|Total|Total of all reporting groups
564134|NCT00606502|B2|Baseline|Erlotinib|
564135|NCT00606502|B1|Baseline|Pralatrexate|
564136|NCT00606502|P2|Participant Flow|Erlotinib|150 mg tablet taken orally daily
564137|NCT00606502|P1|Participant Flow|Pralatrexate|190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks)
564138|NCT00606502|O2|Outcome|Erlotinib|
564139|NCT00606502|O1|Outcome|Pralatrexate|
564140|NCT00606502|O2|Outcome|Erlotinib|
564141|NCT00606502|O1|Outcome|Pralatrexate|
564142|NCT00606502|O2|Outcome|Erlotinib|
564143|NCT00606502|O1|Outcome|Pralatrexate|
564144|NCT00606502|O2|Outcome|Erlotinib|
564145|NCT00606502|O1|Outcome|Pralatrexate|
564146|NCT00606502|E2|Reported Event|Erlotinib|
564147|NCT00606502|E1|Reported Event|Pralatrexate|
564148|NCT00606489|B3|Baseline|Total|Total of all reporting groups
564149|NCT00606489|B2|Baseline|800mg Intravenous Ibuprofen|
564150|NCT00606489|B1|Baseline|Placebo (250 Milliliters Normal Saline)|
564151|NCT00606489|P2|Participant Flow|800mg Intravenous Ibuprofen|
564152|NCT00606489|P1|Participant Flow|Placebo (250 Milliliters Normal Saline)|
564153|NCT00606489|O2|Outcome|800mg Intravenous Ibuprofen|
564157|NCT00606320|B1|Baseline|Arupiprazole|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
564158|NCT00606320|P1|Participant Flow|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
564159|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
564160|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
564161|NCT00606320|E1|Reported Event|Aripiprazole|Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
564162|NCT00606281|B3|Baseline|Total|Total of all reporting groups
564163|NCT00606281|B2|Baseline|Placebo|Subjects were administered placebo once daily for 21 days.
564164|NCT00606281|B1|Baseline|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
564165|NCT00606281|P2|Participant Flow|Placebo|Subjects were administered placebo once daily for 21 days.
564166|NCT00606281|P1|Participant Flow|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
564167|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
564168|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
564169|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
564170|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
564171|NCT00606281|E2|Reported Event|Placebo|Subjects were administered placebo once daily for 21 days.
564172|NCT00606281|E1|Reported Event|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
564173|NCT00606229|B1|Baseline|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
564174|NCT00606229|P1|Participant Flow|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
564175|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
564176|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
564177|NCT00606229|E1|Reported Event|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
564178|NCT00606177|B3|Baseline|Total|Total of all reporting groups
564179|NCT00606177|B2|Baseline|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
564180|NCT00606177|B1|Baseline|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
564181|NCT00606177|P2|Participant Flow|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
564182|NCT00606177|P1|Participant Flow|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
564183|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
564184|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
564185|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
564186|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
564187|NCT00606177|E2|Reported Event|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
564188|NCT00606177|E1|Reported Event|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
564190|NCT00606138|B2|Baseline|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564191|NCT00606138|B1|Baseline|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564192|NCT00606138|P2|Participant Flow|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564193|NCT00606138|P1|Participant Flow|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564194|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564195|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564196|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564197|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564198|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564199|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564200|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564201|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564202|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564203|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564204|NCT00606138|E2|Reported Event|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
564205|NCT00606138|E1|Reported Event|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
564206|NCT00606086|B3|Baseline|Total|Total of all reporting groups
564207|NCT00606086|B2|Baseline|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
564208|NCT00606086|B1|Baseline|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
564209|NCT00606086|P2|Participant Flow|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
564210|NCT00606086|P1|Participant Flow|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
564211|NCT00606086|O2|Outcome|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
564212|NCT00606086|O1|Outcome|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
564213|NCT00606086|E2|Reported Event|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
564243|NCT00606008|B1|Baseline|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
564371|NCT00605813|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
564214|NCT00606086|E1|Reported Event|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
564215|NCT00606034|B1|Baseline|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
564216|NCT00606034|P1|Participant Flow|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
564217|NCT00606034|O1|Outcome|All Subjects|All subjects will receive the IDRSQ at baseline and at Week 52
564218|NCT00606034|O1|Outcome|All Subjects|
564219|NCT00606034|O1|Outcome|All Subjects Using U-500 Regular Insulin Via Omnipod|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
564220|NCT00606034|E1|Reported Event|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
564221|NCT00606021|B3|Baseline|Total|Total of all reporting groups
564222|NCT00606021|B2|Baseline|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564223|NCT00606021|B1|Baseline|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564224|NCT00606021|P3|Participant Flow|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564225|NCT00606021|P2|Participant Flow|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 (mg/m²), IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564226|NCT00606021|P1|Participant Flow|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
564227|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564228|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564229|NCT00606021|O3|Outcome|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
564230|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564231|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564232|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564233|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564234|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564235|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564236|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564237|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564238|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564239|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
564240|NCT00606021|E3|Reported Event|Pemetrexed + Cisplatin - Induction Phase|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles.
564241|NCT00606021|E2|Reported Event|Best Supportive Care - Maintenance Phase|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564242|NCT00606021|E1|Reported Event|Pemetrexed Plus Best Supportive Care - Maintenance Phase|Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
564328|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
564244|NCT00606008|P1|Participant Flow|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
564245|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
564246|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
564247|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
564248|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
564249|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
564250|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
564251|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
564252|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
564253|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
564254|NCT00606008|E3|Reported Event|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
564255|NCT00606008|E2|Reported Event|AA Cohort Patients|Recurrent glioblastoma (GB) patients
564256|NCT00606008|E1|Reported Event|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
564257|NCT00605917|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
564258|NCT00605917|P1|Participant Flow|Sertraline|"Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is patients who are diagnosed with panic disorder. So, all of participants in this study are panic disorder patients."
564259|NCT00605917|O5|Outcome|Drank Alcohol Every Day|Participants who drank alcohol every day and who took Sertraline according to Japanese Package Insert
564260|NCT00605917|O4|Outcome|Drank Alcohol Moderately|Participants who drank alcohol moderately and who took Sertraline according to Japanese Package Insert
564261|NCT00605917|O3|Outcome|Used to Drink Alcohol But Did Not Then|Participants who used to drink alcohol but did not then and who took Sertraline according to Japanese Package Insert
564262|NCT00605917|O2|Outcome|Drank Alcohol Very Occasionally|Participants who drank alcohol very occasionally and who took Sertraline according to Japanese Package Insert
564263|NCT00605917|O1|Outcome|Didn’t Drink Alcohol at All, and Had Never Drunk Alcohol|Participants who didn’t drink alcohol at all, and had never drunk alcohol and who took Sertraline according to Japanese Package Insert
564264|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
564265|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
564266|NCT00605917|O2|Outcome|Without Concomitrant|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
564267|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
564268|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
564269|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
564270|NCT00605917|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
564271|NCT00605917|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
564272|NCT00605917|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
564273|NCT00605917|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
564274|NCT00605917|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
564275|NCT00605917|O2|Outcome|Without History of Treatment|Participants without history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
564276|NCT00605917|O1|Outcome|With History of Treatment|Participants with history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
564277|NCT00605917|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
564278|NCT00605917|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
564279|NCT00605917|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
564329|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
564280|NCT00605917|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
564281|NCT00605917|O3|Outcome|Smoke Then|Participants who smoke then and who took Sertraline according to Japanese Package Insert
564282|NCT00605917|O2|Outcome|Used to Smoke But do Not Then|Participants who used to smoke but didn't then and who took Sertraline according to Japanese Package Insert
564283|NCT00605917|O1|Outcome|Don’t Smoke at All|Participants who didn't smoke at all and who took Sertraline according to Japanese Package Insert
564284|NCT00605917|O2|Outcome|Without Family History|Participants without family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
564285|NCT00605917|O1|Outcome|With Family History|Participants with family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
564286|NCT00605917|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
564287|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
564288|NCT00605917|O5|Outcome|Other Than Those Above|Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
564289|NCT00605917|O4|Outcome|100mg|Participants whose starting dose were 100mg
564290|NCT00605917|O3|Outcome|75mg|Participants whose starting dose were 75mg
564291|NCT00605917|O2|Outcome|50mg|Participants whose starting dose were 50mg
564292|NCT00605917|O1|Outcome|25mg|Participants whose starting dose were 25mg
564293|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
564294|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
564295|NCT00605917|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert.The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
564296|NCT00605904|B3|Baseline|Total|Total of all reporting groups
564297|NCT00605904|B2|Baseline|Placebo|Subjects received 3 tablets of placebo three times daily
564298|NCT00605904|B1|Baseline|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
564299|NCT00605904|P2|Participant Flow|Placebo|Subjects received 3 tablets of placebo three times daily
564300|NCT00605904|P1|Participant Flow|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
564301|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
564302|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
564303|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
564304|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
564305|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
564306|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
564307|NCT00605904|E2|Reported Event|Placebo|Subjects received 3 tablets of placebo three times daily
564308|NCT00605904|E1|Reported Event|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
564309|NCT00605865|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
564310|NCT00605865|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
564311|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
564312|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
564313|NCT00605865|O4|Outcome|Over 65 Years of Age|Participants over 65 years of age who took Sertraline according to Japanese Package Insert
564314|NCT00605865|O3|Outcome|45-64 Years of Age|Participants from 45 to 64 years of age who took Sertraline according to Japanese Package Insert
564315|NCT00605865|O2|Outcome|18-44 Years of Age|Participants from 18 to 44 years of age who took Sertraline according to Japanese Package Insert
564316|NCT00605865|O1|Outcome|Under 18 Years of Age|Participants under 18 years of age who took Sertraline according to Japanese Package Insert
564317|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
564318|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
564319|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
564320|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
564321|NCT00605865|O2|Outcome|Outpatient|Participants as outpatients who took Sertraline according to Japanese Package Insert
564322|NCT00605865|O1|Outcome|Inpatient|Participants as inpatients who took Sertraline according to Japanese Package Insert
564323|NCT00605865|O2|Outcome|Without History of Treatment Prior to Sertraline|Participants without history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
564324|NCT00605865|O1|Outcome|With History of Treatment Prior to Sertraline|Participants with history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
564325|NCT00605865|O3|Outcome|Severe|Participants whose target disease are severe and who took Sertraline according to Japanese Package Insert
564326|NCT00605865|O2|Outcome|Moderate|Participants whose target disease are moderate and who took Sertraline according to Japanese Package Insert
564327|NCT00605865|O1|Outcome|Mild|Participants whose target disease are mild and who took Sertraline according to Japanese Package Insert
565116|NCT00604695|E2|Reported Event|Placebo Control|Two (4mL) doses of sterile saline
564330|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
564331|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
564332|NCT00605865|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
564333|NCT00605865|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
564334|NCT00605865|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
564335|NCT00605865|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
564336|NCT00605865|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
564337|NCT00605865|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
564338|NCT00605865|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
564339|NCT00605865|O2|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
564340|NCT00605865|O1|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
564341|NCT00605865|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
564342|NCT00605865|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
564343|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
564344|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
564345|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
564346|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
564347|NCT00605865|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
564348|NCT00605839|B4|Baseline|Total|Total of all reporting groups
564349|NCT00605839|B3|Baseline|Usual Care|Usual care, without cell phone or glucopak
564350|NCT00605839|B2|Baseline|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
564351|NCT00605839|B1|Baseline|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
564352|NCT00605839|P3|Participant Flow|Usual Care|Usual care, without Glucopak or cell phones.
564353|NCT00605839|P2|Participant Flow|Cell Phone Only|Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic.
564354|NCT00605839|P1|Participant Flow|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic.
564355|NCT00605839|O3|Outcome|Usual Care|Usual care, without cell phone or glucopak
564356|NCT00605839|O2|Outcome|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
564357|NCT00605839|O1|Outcome|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
564358|NCT00605839|E3|Reported Event|Usual Care|Usual care, without cell phone or glucopak
564359|NCT00605839|E2|Reported Event|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
564360|NCT00605839|E1|Reported Event|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
564361|NCT00605813|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
564362|NCT00605813|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
564363|NCT00605813|O2|Outcome|Present History of Intentional Suicidal Ideation|Participants with present intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
564364|NCT00605813|O1|Outcome|Past History of Intentional Suicidal Ideation|Participants with past history of intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
564365|NCT00605813|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
564366|NCT00605813|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
564367|NCT00605813|O2|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
564368|NCT00605813|O1|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
564369|NCT00605813|O2|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
564370|NCT00605813|O1|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
564372|NCT00605813|O1|Outcome|Sertraline Hydrochloride|Participants who took Sertraline according to Japanese Package Insert
564373|NCT00605813|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert
564374|NCT00605722|B1|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564375|NCT00605722|P1|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564376|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564377|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564378|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564379|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564380|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564381|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564382|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564383|NCT00605722|E1|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
564384|NCT00605696|B3|Baseline|Total|Total of all reporting groups
564385|NCT00605696|B2|Baseline|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
564386|NCT00605696|B1|Baseline|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
564387|NCT00605696|P2|Participant Flow|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission.
564388|NCT00605696|P1|Participant Flow|Early Insulin Group|Participants will receive insulin to target glucose of 80-110 mg/dl within 6-12 hours after presenting to ED for up to 48 hours after admission to the ICU.
564389|NCT00605696|O2|Outcome|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
564390|NCT00605696|O1|Outcome|Early Insulin Group|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.
564391|NCT00605696|O2|Outcome|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
564392|NCT00605696|O1|Outcome|Early Insulin Group|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.
564393|NCT00605696|E2|Reported Event|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
564394|NCT00605696|E1|Reported Event|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
564395|NCT00605657|B1|Baseline|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
564396|NCT00605657|P1|Participant Flow|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
564397|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
564398|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
564399|NCT00605657|E1|Reported Event|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
564400|NCT00605540|B1|Baseline|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
564451|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564401|NCT00605540|P1|Participant Flow|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
564402|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
564403|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
564404|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
564405|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
564406|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
564407|NCT00605540|E1|Reported Event|Chronic Obstructive Pulmonary Disease|
564408|NCT00605475|B11|Baseline|Total|Total of all reporting groups
564409|NCT00605475|B10|Baseline|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
564410|NCT00605475|B9|Baseline|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564411|NCT00605475|B8|Baseline|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
564412|NCT00605475|B7|Baseline|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564413|NCT00605475|B6|Baseline|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564414|NCT00605475|B5|Baseline|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564415|NCT00605475|B4|Baseline|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
564416|NCT00605475|B3|Baseline|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564417|NCT00605475|B2|Baseline|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
564418|NCT00605475|B1|Baseline|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
564419|NCT00605475|P10|Participant Flow|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
564420|NCT00605475|P9|Participant Flow|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564421|NCT00605475|P8|Participant Flow|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
564422|NCT00605475|P7|Participant Flow|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564423|NCT00605475|P6|Participant Flow|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564424|NCT00605475|P5|Participant Flow|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564425|NCT00605475|P4|Participant Flow|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
564426|NCT00605475|P3|Participant Flow|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564427|NCT00605475|P2|Participant Flow|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
564428|NCT00605475|P1|Participant Flow|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
564429|NCT00605475|O10|Outcome|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
564430|NCT00605475|O9|Outcome|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564431|NCT00605475|O8|Outcome|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
564432|NCT00605475|O7|Outcome|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564433|NCT00605475|O6|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564434|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564435|NCT00605475|O4|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
564436|NCT00605475|O3|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564437|NCT00605475|O2|Outcome|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
564438|NCT00605475|O1|Outcome|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
564439|NCT00605475|O7|Outcome|Cohort 4: Anakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564440|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) : Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
564441|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564442|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564443|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564444|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564445|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564446|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564447|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
564448|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564449|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564450|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564452|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564453|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564454|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564455|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564456|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
564457|NCT00605475|O5|Outcome|Cohort 3:Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564458|NCT00605475|O4|Outcome|Cohort 3:Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564459|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564460|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564461|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564462|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564463|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
564464|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564465|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564466|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564467|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564468|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564469|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564470|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo of cohort 3 and 4. Single dose IV infusion of Placebo
564471|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564472|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564473|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564474|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564475|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564476|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564477|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
564478|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564479|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564480|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564481|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564482|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564483|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564484|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
564485|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564486|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564487|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564488|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564489|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564490|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564491|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
564492|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564493|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564494|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564495|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564496|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564497|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564498|NCT00605475|O6|Outcome|Pooled (Cohort 3and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
564499|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564500|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564501|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564502|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564503|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564504|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
565117|NCT00604695|E1|Reported Event|Active Treatment|Two (4mg) doses of tenecteplase
564505|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
564506|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564507|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564508|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564509|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564510|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564511|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564512|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. ingle dose IV infusion of Placebo
564513|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564514|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564515|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564516|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564517|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564518|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564519|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
564520|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564521|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564522|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564523|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564524|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564525|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564526|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
564527|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564528|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564529|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564530|NCT00605475|O2|Outcome|Cohort 2:Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564531|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564532|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564533|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
564534|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564535|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564536|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564537|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564538|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564539|NCT00605475|E10|Reported Event|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
564540|NCT00605475|E9|Reported Event|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
564541|NCT00605475|E8|Reported Event|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
564542|NCT00605475|E7|Reported Event|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
564543|NCT00605475|E6|Reported Event|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
564544|NCT00605475|E5|Reported Event|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
564545|NCT00605475|E4|Reported Event|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
564546|NCT00605475|E3|Reported Event|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
564547|NCT00605475|E2|Reported Event|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
564548|NCT00605475|E1|Reported Event|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
564549|NCT00605423|B3|Baseline|Total|Total of all reporting groups
564550|NCT00605423|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
564551|NCT00605423|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
564552|NCT00605423|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
564553|NCT00605423|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
564554|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
564555|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
564556|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
564557|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
564558|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
564559|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
564560|NCT00605423|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
564561|NCT00605423|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
564562|NCT00605384|B3|Baseline|Total|Total of all reporting groups
564563|NCT00605384|B2|Baseline|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564564|NCT00605384|B1|Baseline|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564565|NCT00605384|P2|Participant Flow|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564566|NCT00605384|P1|Participant Flow|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564567|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564568|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564569|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564570|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564571|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564572|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564573|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564574|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564575|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564576|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564577|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564578|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564579|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564580|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564581|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564582|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564583|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564584|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564585|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564586|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564587|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564588|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564589|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564590|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564591|NCT00605384|E2|Reported Event|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
564592|NCT00605384|E1|Reported Event|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
564593|NCT00605358|B3|Baseline|Total|Total of all reporting groups
564594|NCT00605358|B2|Baseline|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
564595|NCT00605358|B1|Baseline|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
564596|NCT00605358|P2|Participant Flow|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
564597|NCT00605358|P1|Participant Flow|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
564598|NCT00605358|O2|Outcome|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
564725|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564599|NCT00605358|O1|Outcome|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
564600|NCT00605358|E2|Reported Event|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
564601|NCT00605358|E1|Reported Event|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
564602|NCT00605345|B3|Baseline|Total|Total of all reporting groups
564603|NCT00605345|B2|Baseline|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564604|NCT00605345|B1|Baseline|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564605|NCT00605345|P2|Participant Flow|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564606|NCT00605345|P1|Participant Flow|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564607|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564608|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564609|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564610|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564611|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564612|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564613|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564614|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564615|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564616|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564617|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564618|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564619|NCT00605345|E2|Reported Event|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
564620|NCT00605345|E1|Reported Event|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
564621|NCT00605319|B1|Baseline|Toviaz (Fesoterodine)|"Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564622|NCT00605319|P1|Participant Flow|Toviaz (Fesoterodine)|"Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564623|NCT00605319|O1|Outcome|Post-void Residual Volume (PVR)|"PVR~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564624|NCT00605319|O1|Outcome|QAvg|"QAvg~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564625|NCT00605319|O1|Outcome|Qmax|"Qmax~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564626|NCT00605319|O1|Outcome|IPSS QoL|"QoL description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564627|NCT00605319|O1|Outcome|IPSS Nocturia|"Nocturia description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564628|NCT00605319|O1|Outcome|IPSS Irritative|"Irritative description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564629|NCT00605319|O1|Outcome|IPSS Obstructive|"Obstructive description~Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564630|NCT00605319|E1|Reported Event|Toviaz (Fesoterodine)|"Toviaz 4mg to 8mg~Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily"
564631|NCT00605306|B3|Baseline|Total|Total of all reporting groups
564632|NCT00605306|B2|Baseline|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
564633|NCT00605306|B1|Baseline|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
564634|NCT00605306|P2|Participant Flow|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
564635|NCT00605306|P1|Participant Flow|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
564636|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
564637|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
564638|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
564639|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
564640|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
564641|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
564642|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
564643|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
564644|NCT00605306|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
564645|NCT00605306|E1|Reported Event|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
564646|NCT00605293|B3|Baseline|Total|Total of all reporting groups
564647|NCT00605293|B2|Baseline|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564648|NCT00605293|B1|Baseline|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564649|NCT00605293|P2|Participant Flow|Epoetin Alfa|Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
564650|NCT00605293|P1|Participant Flow|C.E.R.A|Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564651|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564652|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564653|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564654|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564655|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564656|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564657|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564658|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564659|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564660|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564661|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564662|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564663|NCT00605293|E2|Reported Event|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
564664|NCT00605293|E1|Reported Event|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
564665|NCT00605280|B5|Baseline|Total|Total of all reporting groups
564666|NCT00605280|B4|Baseline|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
564667|NCT00605280|B3|Baseline|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
564668|NCT00605280|B2|Baseline|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564669|NCT00605280|B1|Baseline|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564670|NCT00605280|P4|Participant Flow|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
565118|NCT00604669|B1|Baseline|Those Exposed to TPN|
564671|NCT00605280|P3|Participant Flow|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from the study.
564672|NCT00605280|P2|Participant Flow|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks for 2 years or withdrawing from the study.
564673|NCT00605280|P1|Participant Flow|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564674|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564675|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564676|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564677|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564678|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564679|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564680|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564681|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564682|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564683|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564684|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564685|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564686|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564687|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564688|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564689|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564690|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564691|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564692|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
565119|NCT00604669|P1|Participant Flow|Those Exposed to TPN|
564693|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564694|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564695|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564696|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564697|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564698|NCT00605280|E6|Reported Event|Sham Conversion (Year 3)|Participants who were originally randomized to Sham who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564699|NCT00605280|E5|Reported Event|0.3 mg Pegaptanib Sodium (Year 3)|Participants who were originally randomized to pegaptanib sodium, 0.3 mg who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
564700|NCT00605280|E4|Reported Event|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe) from baseline up to Year 2. Events reported for participants after start of sham, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
564701|NCT00605280|E3|Reported Event|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
564702|NCT00605280|E2|Reported Event|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
564703|NCT00605280|E1|Reported Event|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks from baseline up to 2 years. Includes participants randomized to 0.3 mg pegaptanib sodium and participants randomized to lower doses of pegaptanib sodium who then converted to 0.3 mg pegaptanib sodium; for participants who converted to 0.3 mg pegaptanib sodium, only events that occurred while receiving 0.3 mg pegaptanib sodium treatment are reported.
564704|NCT00605267|B3|Baseline|Total|Total of all reporting groups
564705|NCT00605267|B2|Baseline|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564706|NCT00605267|B1|Baseline|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564707|NCT00605267|P2|Participant Flow|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564708|NCT00605267|P1|Participant Flow|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564709|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564710|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564711|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564712|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564713|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564714|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564715|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564716|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564717|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564718|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564719|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564720|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564721|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564722|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564723|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564724|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
565120|NCT00604669|O1|Outcome|Those Exposed to TPN|
564726|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564727|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564728|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564729|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564730|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564731|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564732|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564733|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564734|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564735|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564736|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564737|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564738|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564739|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564740|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564741|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564742|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564743|NCT00605267|E2|Reported Event|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564744|NCT00605267|E1|Reported Event|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
564745|NCT00605202|B1|Baseline|Entire Study Population|
564746|NCT00605202|P2|Participant Flow|Licorice and HCTZ First, Then Licorice|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the first intervention period, then licorice 32 grams a day in the second intervention period.
564747|NCT00605202|P1|Participant Flow|Licorice First, Then Licorice and HCTZ|Licorice 32 grams a day in the first intervention period, then licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the second intervention period.
564748|NCT00605202|O2|Outcome|Licorice and HCTZ|
564749|NCT00605202|O1|Outcome|Licorice|
564750|NCT00605202|E2|Reported Event|Licorice and HCTZ|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily
564751|NCT00605202|E1|Reported Event|Licorice|Licorice 32 grams a day
564752|NCT00605176|B4|Baseline|Total|Total of all reporting groups
564753|NCT00605176|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564754|NCT00605176|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564755|NCT00605176|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564756|NCT00605176|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564757|NCT00605176|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564758|NCT00605176|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564759|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564760|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
565121|NCT00604669|E1|Reported Event|Those Exposed to TPN|
565122|NCT00604565|B3|Baseline|Total|Total of all reporting groups
564761|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564762|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564763|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564764|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564765|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564766|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564767|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564768|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564769|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564770|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564771|NCT00605176|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564772|NCT00605176|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564773|NCT00605176|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
564774|NCT00605150|B1|Baseline|TheraSphere Treatment|Total number of patients enrolled, TheraSphere treatment
564775|NCT00605150|P1|Participant Flow|Treatment|TheraSphere, TheraSphere-Yttrium 90 microsphere, treatment for patients with unresectable hepatocellular carcinoma (HCC)
564776|NCT00605150|O1|Outcome|TheraSphere Treatment|Total number of patients enrolled TheraSphere treatment for patients with unresectable HCC
564777|NCT00605150|E1|Reported Event|TheraSphere Treatment for Patients With Unresectable HCC|Total number of patients enrolled, TheraSphere treatment for patients with unresectable HCC
564778|NCT00605085|B3|Baseline|Total|Total of all reporting groups
564779|NCT00605085|B2|Baseline|Placebo|Placebo
564780|NCT00605085|B1|Baseline|IC51|IC51
564781|NCT00605085|P2|Participant Flow|Placebo|Placebo
564782|NCT00605085|P1|Participant Flow|IC51|IC51
564783|NCT00605085|O2|Outcome|Placebo|Placebo
564784|NCT00605085|O1|Outcome|IC51|IC51
564785|NCT00605085|E2|Reported Event|Placebo|Placebo
564786|NCT00605085|E1|Reported Event|IC51|IC51
564787|NCT00605072|B4|Baseline|Total|Total of all reporting groups
564788|NCT00605072|B3|Baseline|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564789|NCT00605072|B2|Baseline|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564790|NCT00605072|B1|Baseline|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564791|NCT00605072|P3|Participant Flow|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564792|NCT00605072|P2|Participant Flow|Candesartan|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564793|NCT00605072|P1|Participant Flow|Lisinopril|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564794|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564795|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564796|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564797|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564798|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564799|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564800|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564801|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564802|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564803|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564804|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564805|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564806|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564807|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564808|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564809|NCT00605072|E3|Reported Event|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564810|NCT00605072|E2|Reported Event|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564811|NCT00605072|E1|Reported Event|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
564812|NCT00605033|B3|Baseline|Total|Total of all reporting groups
564813|NCT00605033|B2|Baseline|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564814|NCT00605033|B1|Baseline|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564815|NCT00605033|P2|Participant Flow|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564816|NCT00605033|P1|Participant Flow|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564817|NCT00605033|O2|Outcome|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564818|NCT00605033|O1|Outcome|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564819|NCT00605033|E2|Reported Event|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564820|NCT00605033|E1|Reported Event|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
564821|NCT00604968|B1|Baseline|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564822|NCT00604968|P1|Participant Flow|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564823|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564824|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564825|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564826|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564858|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564827|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564828|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564829|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564830|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564831|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564832|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564833|NCT00604968|E1|Reported Event|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
564834|NCT00604825|B5|Baseline|Total|Total of all reporting groups
564835|NCT00604825|B4|Baseline|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564836|NCT00604825|B3|Baseline|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564837|NCT00604825|B2|Baseline|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564838|NCT00604825|B1|Baseline|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564839|NCT00604825|P4|Participant Flow|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564840|NCT00604825|P3|Participant Flow|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564841|NCT00604825|P2|Participant Flow|GSK232802 25 mg|Eligible participants received GSK232802 25 milligram (mg) tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564842|NCT00604825|P1|Participant Flow|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564843|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564844|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564845|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564846|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564847|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564848|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564849|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564850|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564851|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564852|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564853|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564854|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564855|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564856|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564857|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564859|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564860|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564861|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564862|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564863|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564864|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564865|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564866|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564867|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564868|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564869|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564870|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564871|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564872|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564873|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564874|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564875|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564876|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564877|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564878|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564879|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564880|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564881|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564882|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564883|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564884|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564885|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564886|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564887|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564888|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564889|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564890|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565105|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
564891|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564892|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564893|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564894|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564895|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564896|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564897|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564898|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564899|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564900|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564901|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564902|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564903|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564904|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564905|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564906|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564907|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564908|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564909|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564910|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564911|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564912|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564913|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564914|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564915|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564916|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564917|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564918|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564919|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564920|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564921|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564922|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565106|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
564923|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564924|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564925|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564926|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564927|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564928|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564929|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564930|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564931|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564932|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564933|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564934|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564935|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564936|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564937|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564938|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564939|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564940|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564941|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564942|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564943|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564944|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564945|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564946|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564947|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564948|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564949|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564950|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564951|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564952|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564953|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564954|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565107|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
564955|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564956|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564957|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564958|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564959|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564960|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564961|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564962|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564963|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564964|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564965|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564966|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564967|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564968|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564969|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564970|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564971|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564972|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564973|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564974|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564975|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564976|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564977|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564978|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564979|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564980|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564981|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564982|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564983|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564984|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564985|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564986|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565108|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
564987|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564988|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564989|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564990|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564991|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564992|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564993|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564994|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564995|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564996|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564997|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
564998|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
564999|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565000|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565001|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565002|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565003|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565004|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565005|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565006|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565007|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565008|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565009|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565010|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565011|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565012|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565013|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565014|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565015|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565016|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565017|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565018|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565109|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
565019|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565020|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565021|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565022|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565023|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565024|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565025|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565026|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565027|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565028|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565029|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565030|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565031|NCT00604825|O4|Outcome|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565032|NCT00604825|O3|Outcome|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565033|NCT00604825|O2|Outcome|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565034|NCT00604825|O1|Outcome|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565035|NCT00604825|E4|Reported Event|Premarin 0.3 mg|Eligible participants received Premarin 0.3 mg capsules, one capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565036|NCT00604825|E3|Reported Event|GSK232802 75 mg|Eligible participants received GSK232802 75 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565037|NCT00604825|E2|Reported Event|GSK232802 25 mg|Eligible participants received GSK232802 25 mg tablets, one tablet via oral route at approximately the same time each morning for a total period of 12 weeks.
565038|NCT00604825|E1|Reported Event|Placebo|Eligible participants received placebo tablets/capsules to match GSK232802 tablets and Premarin capsules, one tablet or capsule via oral route at approximately the same time each morning for a total period of 12 weeks.
565039|NCT00604812|B4|Baseline|Total|Total of all reporting groups
565040|NCT00604812|B3|Baseline|Panel C|Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)
565041|NCT00604812|B2|Baseline|Panel B|Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3)
565042|NCT00604812|B1|Baseline|Panel A|Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3)
565043|NCT00604812|P6|Participant Flow|Panel C Placebo|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
565044|NCT00604812|P5|Participant Flow|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
565045|NCT00604812|P4|Participant Flow|Panel B Placebo|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
565046|NCT00604812|P3|Participant Flow|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
565047|NCT00604812|P2|Participant Flow|Panel A Placebo|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
565048|NCT00604812|P1|Participant Flow|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
565049|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
565050|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
565051|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
565052|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
565053|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
565054|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
565055|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
565056|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
565057|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
565058|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
565059|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
565060|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
565061|NCT00604812|O3|Outcome|Placebo|Combined Placebo groups from panels A, B, and C.
565062|NCT00604812|O2|Outcome|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
565063|NCT00604812|O1|Outcome|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
565064|NCT00604812|E3|Reported Event|Placebo|Combined Placebo groups from panels A, B, and C.
565065|NCT00604812|E2|Reported Event|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
565066|NCT00604812|E1|Reported Event|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
565067|NCT00604786|B3|Baseline|Total|Total of all reporting groups
565068|NCT00604786|B2|Baseline|Placebo|"placebo: IgE 30-100 int. units/mL: 30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 4 weeks~IgE >100-200 int. units/mL:~30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 2 weeks~IgE >200-300 int. units/mL:~30-60 kg: placebo every 4 weeks >60-90 kg: placebo every 2 weeks >90-150 kg: placebo every 2 weeks~IgE >300-400 int. units/mL:~30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose~IgE >400-500 int. units/mL:~30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose~IgE >500-600 int. units/mL:~30-60 kg: placebo every 2 weeks >60-70 kg: placebo every 2 weeks >70 kg: Do not administer dose~IgE >600-700 int. units/mL:~30-60 kg: placebo every 2 weeks >60 kg: Do not administer dose"
565069|NCT00604786|B1|Baseline|Active Treatment|"This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~omalizumab: IgE 30-100 int. units/mL: 30-90 kg: 150 mg every 4 weeks >90-150 kg: 300 mg every 4 weeks~IgE >100-200 int. units/mL:~30-90 kg: 300 mg every 4 weeks >90-150 kg: 225 mg every 2 weeks~IgE >200-300 int. units/mL:~30-60 kg: 300 mg every 4 weeks >60-90 kg: 225 mg every 2 weeks >90-150 kg: 300 mg every 2 weeks~IgE >300-400 int. units/mL:~30-70 kg: 225 mg every 2 weeks >70-90 kg: 300 mg every 2 weeks >90 kg: Do not administer dose~IgE >400-500 int. units/mL:~30-70 kg: 300 mg every 2 weeks >70-90 kg: 375 mg every 2 weeks >90 kg: Do not administer dose~IgE >500-600 int. units/mL:~30-60 kg: 300 mg every 2 weeks >60-70 kg: 375 mg every 2 weeks >70 kg: Do not administer dose~IgE >600-700 int. units/mL:~30-60 kg: 375 mg every 2 weeks >60 kg: Do not administer dose"
565070|NCT00604786|P2|Participant Flow|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
565071|NCT00604786|P1|Participant Flow|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and immunoglobulin E (IgE) based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
565110|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
565111|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
565112|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
565113|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
565072|NCT00604786|O2|Outcome|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
565073|NCT00604786|O1|Outcome|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
565074|NCT00604786|E2|Reported Event|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
565075|NCT00604786|E1|Reported Event|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
565076|NCT00604721|B1|Baseline|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
565077|NCT00604721|P1|Participant Flow|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
565078|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
565079|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
565080|NCT00604721|O1|Outcome|Safety Cohort: AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was determined by the algorithm presented in the safety cohort."
565081|NCT00604721|E1|Reported Event|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
565082|NCT00604708|B3|Baseline|Total|Total of all reporting groups
565083|NCT00604708|B2|Baseline|JE-VAX|JE-VAX
565084|NCT00604708|B1|Baseline|IC51|IC51
565085|NCT00604708|P2|Participant Flow|JE-VAX|JE-VAX
565086|NCT00604708|P1|Participant Flow|IC51|IC51
565087|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
565088|NCT00604708|O1|Outcome|IC51|IC51
565089|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
565090|NCT00604708|O1|Outcome|IC51|IC51
565091|NCT00604708|E2|Reported Event|JE-VAX|JE-VAX
565092|NCT00604708|E1|Reported Event|IC51|IC51
565093|NCT00604695|B3|Baseline|Total|Total of all reporting groups
565094|NCT00604695|B2|Baseline|Placebo Control|Two (4mL) doses of sterile saline
565095|NCT00604695|B1|Baseline|Active Treatment|Two (4mg) doses of tenecteplase
565096|NCT00604695|P2|Participant Flow|Placebo Control|Two (4mL) doses of sterile saline
565097|NCT00604695|P1|Participant Flow|Active Treatment|Two (4mg) doses of tenecteplase
565098|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
565099|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
565100|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
565101|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
565102|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
565103|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
565104|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
565123|NCT00604565|B2|Baseline|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
565124|NCT00604565|B1|Baseline|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
565125|NCT00604565|P2|Participant Flow|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
565126|NCT00604565|P1|Participant Flow|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
565127|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
565128|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
565129|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
565130|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
565131|NCT00604565|E2|Reported Event|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
565132|NCT00604565|E1|Reported Event|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
565133|NCT00604552|B3|Baseline|Total|Total of all reporting groups
565134|NCT00604552|B2|Baseline|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
565135|NCT00604552|B1|Baseline|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
565136|NCT00604552|P2|Participant Flow|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
565137|NCT00604552|P1|Participant Flow|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
565138|NCT00604552|O2|Outcome|PS Registry|"All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic~AneuRx Stent Graft: Abdominal Aortic Aneurysm Repair"
565139|NCT00604552|O1|Outcome|Lifeline Registry|"All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)~AneuRx Stent Graft: Abdominal Aortic Aneurysm Repair"
565140|NCT00604552|O2|Outcome|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
565141|NCT00604552|O1|Outcome|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
565142|NCT00604552|E2|Reported Event|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
565143|NCT00604552|E1|Reported Event|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
565144|NCT00604500|B1|Baseline|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
565145|NCT00604500|P1|Participant Flow|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
565146|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
565147|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
565148|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
565149|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
565150|NCT00604500|E1|Reported Event|MF/F MDI 100/10 mcg BID|Included all participants that received 100/10 mcg BID (with and without dose counter)
565151|NCT00604461|B1|Baseline|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
565250|NCT00604175|P3|Participant Flow|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565152|NCT00604461|P1|Participant Flow|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
565153|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
565154|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
565155|NCT00604461|E1|Reported Event|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
565156|NCT00604383|B3|Baseline|Total|Total of all reporting groups
565157|NCT00604383|B2|Baseline|Placebo|1 tablet, orally, daily, for up to 42 months
565158|NCT00604383|B1|Baseline|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
565159|NCT00604383|P2|Participant Flow|Placebo|1 tablet, orally, daily, for up to 42 months
565160|NCT00604383|P1|Participant Flow|Ruboxistaurin|One 32-milligram (mg) tablet, orally, daily, for up to 42 months
565161|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
565162|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
565163|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
565164|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
565165|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
565166|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
565167|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
565168|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
565169|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
565170|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
565171|NCT00604383|E2|Reported Event|Placebo|1 tablet, orally, daily, for up to 42 months
565172|NCT00604383|E1|Reported Event|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
565173|NCT00604279|B3|Baseline|Total|Total of all reporting groups
565174|NCT00604279|B2|Baseline|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565175|NCT00604279|B1|Baseline|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565176|NCT00604279|P2|Participant Flow|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565177|NCT00604279|P1|Participant Flow|Paliperidone Palmitate|Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565178|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565179|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565180|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565181|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565251|NCT00604175|P2|Participant Flow|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565182|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565183|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565184|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565185|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565186|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565187|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565188|NCT00604279|E2|Reported Event|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
565189|NCT00604279|E1|Reported Event|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
565190|NCT00604214|B3|Baseline|Total|Total of all reporting groups
565191|NCT00604214|B2|Baseline|Placebo|0.9% sodium chloride, intravenous, 96 hours
565192|NCT00604214|B1|Baseline|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565193|NCT00604214|P2|Participant Flow|Placebo|0.9% sodium chloride, intravenous, 96 hours
565194|NCT00604214|P1|Participant Flow|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565195|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565196|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565197|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565198|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565199|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565200|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565201|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565202|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565203|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565204|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565205|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565206|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565207|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565208|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565209|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565210|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565211|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565212|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565213|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565214|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565215|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565216|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565217|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565218|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565219|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
565220|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565221|NCT00604214|E2|Reported Event|Placebo|0.9% sodium chloride, intravenous, 96 hours
565222|NCT00604214|E1|Reported Event|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
565223|NCT00604188|B3|Baseline|Total|Total of all reporting groups
565224|NCT00604188|B2|Baseline|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565225|NCT00604188|B1|Baseline|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565226|NCT00604188|P2|Participant Flow|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565227|NCT00604188|P1|Participant Flow|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565228|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565229|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565230|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565231|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565232|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565233|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565234|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565235|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565236|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565237|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565238|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565239|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565240|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565241|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565242|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565243|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565244|NCT00604188|E2|Reported Event|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565245|NCT00604188|E1|Reported Event|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
565246|NCT00604175|B4|Baseline|Total|Total of all reporting groups
565247|NCT00604175|B3|Baseline|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565248|NCT00604175|B2|Baseline|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565249|NCT00604175|B1|Baseline|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565252|NCT00604175|P1|Participant Flow|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565253|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565254|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565255|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565256|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565257|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565258|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565259|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565260|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565261|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565262|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565263|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565264|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565265|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV18 at baseline.
565266|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV18 at baseline.
565267|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV18 at baseline.
565268|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV16 at baseline.
565269|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV16 at baseline.
565270|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV16 at baseline.
565271|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV11 at baseline.
565272|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV11 at baseline.
565273|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV11 at baseline.
565274|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV6 at baseline.
565275|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV6 at baseline.
565276|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV6 at baseline.
565277|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV18 at baseline.
565278|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV18 at baseline.
565279|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV18 at baseline.
565280|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV16 at baseline.
565281|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV16 at baseline.
565282|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV16 at baseline.
565283|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV11 at baseline.
565284|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV11 at baseline.
565285|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV11 at baseline.
565286|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV6 at baseline.
565287|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV6 at baseline.
565288|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV6 at baseline.
565289|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565290|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565291|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565292|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565293|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565294|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565295|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565296|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565297|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565298|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565299|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565300|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565301|NCT00604175|E3|Reported Event|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565302|NCT00604175|E2|Reported Event|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565303|NCT00604175|E1|Reported Event|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
565304|NCT00604162|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
565305|NCT00604162|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
565306|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
565307|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
565308|NCT00604162|O1|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
565309|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
565310|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
565311|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
565312|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
565313|NCT00604162|E2|Reported Event|Adverse Events Related to the Capsule|AE related to the capsule endoscopy procedure
565314|NCT00604162|E1|Reported Event|Adverse Events Related to Colonoscopy|AE related to colonoscopy procedure
565315|NCT00604045|B3|Baseline|Total|Total of all reporting groups
565316|NCT00604045|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
565317|NCT00604045|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
565318|NCT00604045|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
565319|NCT00604045|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
565320|NCT00604045|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
565354|NCT00603902|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
565355|NCT00603902|P3|Participant Flow|Matching Placebo|matching placebo tablets
565356|NCT00603902|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
565357|NCT00603902|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
565321|NCT00604045|O1|Outcome|1 Attention Bias Modification (ABM)|"The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.~be."
565322|NCT00604045|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
565323|NCT00604045|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
565324|NCT00604019|B3|Baseline|Total|Total of all reporting groups
565325|NCT00604019|B2|Baseline|Norepinephrine|Patients that get NE infusion
565326|NCT00604019|B1|Baseline|Dopamine|Patients that get DA infusion
565327|NCT00604019|P2|Participant Flow|Norepinephrine|Norepinephrine infusion via central catheter
565328|NCT00604019|P1|Participant Flow|Dopamine|Dopaime infusion via central catheter
565329|NCT00604019|O2|Outcome|Norepinephrine|Patients getting NE infusion
565330|NCT00604019|O1|Outcome|Dopamine|Patients getting DA infusion
565331|NCT00604019|E2|Reported Event|Norepinephrine|Patients that get NE infusion
565332|NCT00604019|E1|Reported Event|Dopamine|Patients that get DA infusion
565333|NCT00603993|B1|Baseline|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565334|NCT00603993|P1|Participant Flow|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565335|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565336|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565337|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565338|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565339|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565340|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565341|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565342|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565343|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565344|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565345|NCT00603993|E1|Reported Event|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
565346|NCT00603915|B1|Baseline|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
565347|NCT00603915|P1|Participant Flow|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
565348|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
565349|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
565350|NCT00603915|E1|Reported Event|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
565351|NCT00603902|B4|Baseline|Total|Total of all reporting groups
565352|NCT00603902|B3|Baseline|Matching Placebo|matching placebo tablets
565353|NCT00603902|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
565358|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
565359|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
565360|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
565361|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
565362|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
565363|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
565364|NCT00603902|E3|Reported Event|Matching Placebo|matching placebo tablets
565365|NCT00603902|E2|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
565366|NCT00603902|E1|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
565367|NCT00603889|B1|Baseline|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
565368|NCT00603889|P1|Participant Flow|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
565369|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
565370|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
565371|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
565372|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
565373|NCT00603889|E1|Reported Event|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
565374|NCT00603837|B3|Baseline|Total|Total of all reporting groups
565375|NCT00603837|B2|Baseline|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
565376|NCT00603837|B1|Baseline|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
565377|NCT00603837|P2|Participant Flow|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
565378|NCT00603837|P1|Participant Flow|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
565379|NCT00603837|O2|Outcome|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
565380|NCT00603837|O1|Outcome|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
565381|NCT00603837|E2|Reported Event|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
565382|NCT00603837|E1|Reported Event|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
565383|NCT00603798|B4|Baseline|Total|Total of all reporting groups
565384|NCT00603798|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565385|NCT00603798|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565386|NCT00603798|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565387|NCT00603798|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565388|NCT00603798|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565389|NCT00603798|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565390|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565391|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565392|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565687|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565688|NCT00603525|O1|Outcome|Placebo|
565689|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565690|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565393|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565394|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565395|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565396|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565397|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565398|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565399|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565400|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565401|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565402|NCT00603798|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565403|NCT00603798|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565404|NCT00603798|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
565405|NCT00603746|B7|Baseline|Total|Total of all reporting groups
565406|NCT00603746|B6|Baseline|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565407|NCT00603746|B5|Baseline|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565408|NCT00603746|B4|Baseline|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565409|NCT00603746|B3|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565410|NCT00603746|B2|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565411|NCT00603746|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565412|NCT00603746|P6|Participant Flow|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the
565413|NCT00603746|P5|Participant Flow|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565691|NCT00603525|O1|Outcome|Placebo|
565414|NCT00603746|P4|Participant Flow|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565415|NCT00603746|P3|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565416|NCT00603746|P2|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565417|NCT00603746|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565418|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565419|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565420|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565421|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565422|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565423|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565424|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565425|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565426|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565427|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565428|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565429|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565430|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565431|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565692|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565693|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565694|NCT00603525|O1|Outcome|Placebo|
565695|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565696|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565432|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565433|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565434|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565435|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565436|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565437|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565438|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565439|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565440|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565441|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565442|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565443|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565444|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565445|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565446|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565447|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565448|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565449|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565450|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565451|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565452|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565453|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565454|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565455|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565456|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565457|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565458|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565459|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565460|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565461|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565462|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565463|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565464|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565465|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565466|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565467|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565468|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565469|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565470|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565471|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565472|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565473|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565474|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565475|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565476|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565477|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565478|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565479|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565480|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565481|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565482|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565483|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565484|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565485|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565486|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565487|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565488|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565489|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565490|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565491|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565492|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565493|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565494|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565495|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565496|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565497|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565498|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565499|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565500|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565501|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565502|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565503|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565504|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565505|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565506|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565697|NCT00603525|O1|Outcome|Placebo|
565698|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565699|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565700|NCT00603525|O1|Outcome|Placebo|
565701|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565507|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565508|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565509|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565510|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565511|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565512|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565513|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565514|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565515|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565516|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565517|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565518|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565519|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565520|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565521|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565522|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565523|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565524|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565702|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565703|NCT00603525|O1|Outcome|Placebo|
565704|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565705|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565706|NCT00603525|O1|Outcome|Placebo|
565525|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565526|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565527|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565528|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565529|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565530|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565531|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565532|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565533|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565534|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565535|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565536|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565537|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565538|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565539|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565540|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565541|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565542|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565707|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565708|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565709|NCT00603525|O1|Outcome|Placebo|
565710|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565711|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565543|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565544|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565545|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565546|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565547|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565548|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565549|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565550|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565551|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565552|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565553|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565554|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565555|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565556|NCT00603746|E6|Reported Event|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565557|NCT00603746|E5|Reported Event|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565558|NCT00603746|E4|Reported Event|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565559|NCT00603746|E3|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565560|NCT00603746|E2|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565712|NCT00603525|O1|Outcome|Placebo|
565713|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565714|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565715|NCT00603525|O1|Outcome|Placebo|
565716|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565561|NCT00603746|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
565562|NCT00603733|B3|Baseline|Total|Total of all reporting groups
565563|NCT00603733|B2|Baseline|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
565564|NCT00603733|B1|Baseline|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
565565|NCT00603733|P2|Participant Flow|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
565566|NCT00603733|P1|Participant Flow|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
565567|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
565568|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
565569|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
565570|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
565571|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
565572|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
565573|NCT00603733|E2|Reported Event|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
565574|NCT00603733|E1|Reported Event|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
565575|NCT00603642|B3|Baseline|Total|Total of all reporting groups
565576|NCT00603642|B2|Baseline|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
565577|NCT00603642|B1|Baseline|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
565578|NCT00603642|P2|Participant Flow|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
565579|NCT00603642|P1|Participant Flow|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
565580|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
565581|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
565582|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
565583|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
565584|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
565585|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
565586|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
565587|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
565588|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
565589|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
565590|NCT00603642|E2|Reported Event|Romiplostim|
565591|NCT00603642|E1|Reported Event|Placebo|
565592|NCT00603590|B3|Baseline|Total|Total of all reporting groups
565593|NCT00603590|B2|Baseline|Control|Identical placebo tablet
565594|NCT00603590|B1|Baseline|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
565595|NCT00603590|P2|Participant Flow|Control|Identical placebo tablet
565596|NCT00603590|P1|Participant Flow|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
565597|NCT00603590|O2|Outcome|Control|Identical placebo tablet
565598|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
565599|NCT00603590|O2|Outcome|Control|Identical placebo tablet
565600|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
565601|NCT00603590|O2|Outcome|Control|Identical placebo tablet
565602|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
565603|NCT00603590|E2|Reported Event|Control|Identical placebo tablet
565604|NCT00603590|E1|Reported Event|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
565605|NCT00603564|B3|Baseline|Total|Total of all reporting groups
565606|NCT00603564|B2|Baseline|Venturi|O2 administration via a conventional Venturi mask
565607|NCT00603564|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
565608|NCT00603564|P2|Participant Flow|Venturi|O2 administration via a conventional Venturi mask
565609|NCT00603564|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
565610|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
565611|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
565612|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
565613|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
565614|NCT00603564|E2|Reported Event|Venturi|O2 administration via a conventional Venturi mask
565615|NCT00603564|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
565616|NCT00603538|B4|Baseline|Total|Total of all reporting groups
565717|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565718|NCT00603525|O1|Outcome|Placebo|
565719|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
601986|NCT00518323|O4|Outcome|Placebo|
565617|NCT00603538|B3|Baseline|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565618|NCT00603538|B2|Baseline|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565619|NCT00603538|B1|Baseline|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565620|NCT00603538|P3|Participant Flow|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565621|NCT00603538|P2|Participant Flow|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565622|NCT00603538|P1|Participant Flow|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565623|NCT00603538|O3|Outcome|CP-751,871 20mg/kg in Combination With Chemotherapy Agents|CP-751,871 20mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565624|NCT00603538|O2|Outcome|CP-751,871 10mg/kg in Combination With Chemotherapy Agents|CP-751,871 10mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565625|NCT00603538|O1|Outcome|CP-751,871 6mg/kg in Combination With Chemotherapy Agents|CP-751,871 6mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565626|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565627|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565628|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565629|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565630|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565631|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565632|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565633|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565634|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565635|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565636|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565637|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565638|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565639|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565640|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565641|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565642|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565643|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565644|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565645|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565646|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565647|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565648|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565649|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565650|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565651|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565652|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565653|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565654|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565655|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565656|NCT00603538|E3|Reported Event|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565657|NCT00603538|E2|Reported Event|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565658|NCT00603538|E1|Reported Event|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
565659|NCT00603525|B3|Baseline|Total|Total of all reporting groups
565660|NCT00603525|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565661|NCT00603525|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565662|NCT00603525|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
565663|NCT00603525|P2|Participant Flow|Ofatumumab|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
565664|NCT00603525|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
565665|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565666|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565667|NCT00603525|O1|Outcome|Placebo|
565668|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565669|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565670|NCT00603525|O1|Outcome|Placebo|
565671|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565672|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565673|NCT00603525|O1|Outcome|Placebo|
565674|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565675|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565676|NCT00603525|O1|Outcome|Placebo|
565677|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565678|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565679|NCT00603525|O1|Outcome|Placebo|
565680|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565681|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565682|NCT00603525|O1|Outcome|Placebo|
565683|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565684|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565685|NCT00603525|O1|Outcome|Placebo|
565686|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565720|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565721|NCT00603525|O1|Outcome|Placebo|
565722|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565723|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565724|NCT00603525|O1|Outcome|Placebo|
565725|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565726|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565727|NCT00603525|O1|Outcome|Placebo|
565728|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565729|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565730|NCT00603525|O1|Outcome|Placebo|
565731|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565732|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565733|NCT00603525|O1|Outcome|Placebo|
565734|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
565735|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
565736|NCT00603525|O1|Outcome|Placebo|
565737|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565738|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565739|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565740|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565741|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565742|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565743|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565744|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565745|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565746|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565747|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565748|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565749|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565750|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565751|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565752|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565753|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565754|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565755|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565756|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565757|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565826|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565758|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565759|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565760|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565761|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565762|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565763|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565764|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565765|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565766|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565767|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565768|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565769|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565770|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565771|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565772|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565773|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565774|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565775|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565776|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565777|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565778|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565779|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565780|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565781|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565782|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565827|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565783|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565784|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565785|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565786|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
565787|NCT00603525|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
565788|NCT00603525|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
565789|NCT00603525|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
565790|NCT00603512|B6|Baseline|Total|Total of all reporting groups
565791|NCT00603512|B5|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565792|NCT00603512|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565793|NCT00603512|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565794|NCT00603512|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565795|NCT00603512|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565796|NCT00603512|P5|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565797|NCT00603512|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565798|NCT00603512|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565799|NCT00603512|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565800|NCT00603512|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565801|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565802|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565803|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565804|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565805|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565806|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565807|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565808|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565809|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565810|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565811|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565812|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565813|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565814|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565815|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565816|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565817|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565818|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565819|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565820|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565821|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565822|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565823|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565824|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565825|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565828|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565829|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565830|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565831|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565832|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565833|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565834|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565835|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565836|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565837|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565838|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565839|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565840|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565841|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565842|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565843|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565844|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565845|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565846|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565847|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565848|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565849|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565850|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565851|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565852|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565853|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565854|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565855|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565856|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565857|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565858|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565859|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565860|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565861|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565862|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565863|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565864|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565865|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565866|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565867|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565868|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565869|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565870|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565871|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565872|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565873|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565874|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565875|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565876|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565877|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565878|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565879|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565880|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565881|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565882|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565883|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565884|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565885|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565886|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565887|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565888|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565889|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565890|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565891|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565892|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565893|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565894|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565895|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565896|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565897|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565898|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565899|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565900|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565901|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565902|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565903|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565904|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565905|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565906|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565907|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565908|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565909|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565910|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565911|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565912|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565913|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565914|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565915|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565916|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565917|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565918|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565919|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565920|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565921|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565922|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565923|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565924|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565925|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565926|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565927|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565928|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565929|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565930|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565931|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565932|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565933|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565934|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565935|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565936|NCT00603512|E5|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
565937|NCT00603512|E4|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
565938|NCT00603512|E3|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
565939|NCT00603512|E2|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
565940|NCT00603512|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
565941|NCT00603473|B1|Baseline|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
566423|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
565942|NCT00603473|P1|Participant Flow|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
565943|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
565944|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
565945|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
565946|NCT00603473|E1|Reported Event|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
565947|NCT00603447|B8|Baseline|Total|Total of all reporting groups
565948|NCT00603447|B7|Baseline|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565949|NCT00603447|B6|Baseline|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565950|NCT00603447|B5|Baseline|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565951|NCT00603447|B4|Baseline|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565952|NCT00603447|B3|Baseline|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565953|NCT00603447|B2|Baseline|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565954|NCT00603447|B1|Baseline|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565955|NCT00603447|P7|Participant Flow|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
566012|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
565956|NCT00603447|P6|Participant Flow|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565957|NCT00603447|P5|Participant Flow|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565958|NCT00603447|P4|Participant Flow|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565959|NCT00603447|P3|Participant Flow|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565960|NCT00603447|P2|Participant Flow|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565961|NCT00603447|P1|Participant Flow|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565962|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565963|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565964|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565965|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565966|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565967|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565968|NCT00603447|O7|Outcome|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565969|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565970|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565971|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565972|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565973|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
565974|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
566424|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
649744|NCT00402987|O4|Outcome|Placebo|
565975|NCT00603447|E7|Reported Event|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
565976|NCT00603447|E6|Reported Event|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
565977|NCT00603447|E5|Reported Event|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
565978|NCT00603447|E4|Reported Event|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
565979|NCT00603447|E3|Reported Event|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
565980|NCT00603447|E2|Reported Event|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
565981|NCT00603447|E1|Reported Event|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
565982|NCT00603408|B1|Baseline|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565983|NCT00603408|P1|Participant Flow|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565984|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565985|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565986|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565987|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565988|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565989|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565990|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565991|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
566156|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
568562|NCT00596752|B3|Baseline|Total|Total of all reporting groups
565992|NCT00603408|E1|Reported Event|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
565993|NCT00603382|B7|Baseline|Total|Total of all reporting groups
565994|NCT00603382|B6|Baseline|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
565995|NCT00603382|B5|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
565996|NCT00603382|B4|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
565997|NCT00603382|B3|Baseline|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
565998|NCT00603382|B2|Baseline|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
565999|NCT00603382|B1|Baseline|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566000|NCT00603382|P6|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566001|NCT00603382|P5|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566002|NCT00603382|P4|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566003|NCT00603382|P3|Participant Flow|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566004|NCT00603382|P2|Participant Flow|GW685698X 25 µg OD|Participants received GW685698X 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566005|NCT00603382|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566006|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566007|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566008|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566009|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566010|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566011|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566157|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566425|NCT00603187|E1|Reported Event|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
566013|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566014|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566015|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566016|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566017|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566018|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566019|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566020|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566021|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566022|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566023|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566024|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566025|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566026|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566027|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566028|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566029|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566030|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566031|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566032|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566158|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566033|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566034|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566035|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566036|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566037|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566038|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566039|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566040|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566041|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566042|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566043|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566044|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566045|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566046|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566047|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566048|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566049|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566050|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566051|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566052|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566159|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
652280|NCT00396877|O1|Outcome|Placebo|
566053|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566054|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566055|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566056|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566057|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566058|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566059|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566060|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566061|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566062|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566063|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566064|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566065|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566066|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566067|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566068|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566069|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566070|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566071|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566072|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566160|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566073|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566074|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566075|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566076|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566077|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566078|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566079|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566080|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566081|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566082|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566083|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566084|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566085|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566086|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566087|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566088|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566089|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566090|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566091|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566092|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566161|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566093|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566094|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566095|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566096|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566097|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566098|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566099|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566100|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566101|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566102|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566103|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566104|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566105|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566106|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566107|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566108|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566109|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566110|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566111|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566112|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566162|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566113|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566114|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566115|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566116|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566117|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566118|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566119|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566120|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566121|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566122|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566123|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566124|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566125|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566126|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566127|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566128|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566129|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566130|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566131|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566132|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566163|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566426|NCT00603044|B3|Baseline|Total|Total of all reporting groups
566133|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566134|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566135|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566136|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566137|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566138|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566139|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566140|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566141|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566142|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566143|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566144|NCT00603382|E6|Reported Event|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566145|NCT00603382|E5|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566146|NCT00603382|E4|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566147|NCT00603382|E3|Reported Event|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566148|NCT00603382|E2|Reported Event|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566149|NCT00603382|E1|Reported Event|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566150|NCT00603304|B3|Baseline|Total|Total of all reporting groups
566151|NCT00603304|B2|Baseline|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566152|NCT00603304|B1|Baseline|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566153|NCT00603304|P2|Participant Flow|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566154|NCT00603304|P1|Participant Flow|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566155|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566427|NCT00603044|B2|Baseline|No Treatment|Subjects in this arm received no treatment.
566164|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566165|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566166|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566167|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566168|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566169|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566170|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566171|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566172|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566173|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566174|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566175|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566176|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566177|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566178|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566179|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
566180|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
566181|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
566182|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
566183|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
566184|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
566185|NCT00603304|E2|Reported Event|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
566186|NCT00603304|E1|Reported Event|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
566187|NCT00603291|B4|Baseline|Total|Total of all reporting groups
566188|NCT00603291|B3|Baseline|Matching Placebo|matching placebo tablets
566189|NCT00603291|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
566190|NCT00603291|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
566191|NCT00603291|P3|Participant Flow|Matching Placebo|matching placebo tablets
566192|NCT00603291|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
566193|NCT00603291|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
566194|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
566195|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
566196|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
566197|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
566198|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
566199|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
566200|NCT00603291|E3|Reported Event|Matching Placebo|matching placebo tablets
566201|NCT00603291|E2|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
566202|NCT00603291|E1|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
566203|NCT00603278|B7|Baseline|Total|Total of all reporting groups
566204|NCT00603278|B6|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566205|NCT00603278|B5|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566206|NCT00603278|B4|Baseline|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566375|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
569338|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
566207|NCT00603278|B3|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566208|NCT00603278|B2|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566209|NCT00603278|B1|Baseline|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566210|NCT00603278|P6|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566211|NCT00603278|P5|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566212|NCT00603278|P4|Participant Flow|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566213|NCT00603278|P3|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566214|NCT00603278|P2|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566215|NCT00603278|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566216|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566217|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566218|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566219|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566220|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566221|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566222|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566223|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566224|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566225|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566226|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566227|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566228|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566229|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566230|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566231|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566232|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566233|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566234|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566235|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566236|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566237|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566238|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566239|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566240|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566241|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566242|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566243|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566244|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566245|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566246|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566890|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566247|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566248|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566249|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566250|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566251|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566252|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566253|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566254|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566255|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566256|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566257|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566258|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566259|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566260|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566261|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566262|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566263|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566264|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566265|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566266|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566376|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566267|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566268|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566269|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566270|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566271|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566272|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566273|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566274|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566275|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566276|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566277|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566278|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566279|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566280|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566281|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566282|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566283|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566284|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566285|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566286|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566419|NCT00603239|E1|Reported Event|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566287|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566288|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566289|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566290|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566291|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566292|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566293|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566294|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566295|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566296|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566297|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566298|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566299|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566300|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566301|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566302|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566303|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566304|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566305|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566306|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566420|NCT00603187|B1|Baseline|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
566307|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566308|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566309|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566310|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566311|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566312|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566313|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566314|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566315|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566316|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566317|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566318|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566319|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566320|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566321|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566322|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566323|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566324|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566325|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566326|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566421|NCT00603187|P1|Participant Flow|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
569339|NCT00594425|O3|Outcome|Vehicle PDT|
566327|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566328|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566329|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566330|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566331|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566332|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566333|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566334|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566335|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566336|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566337|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566338|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566339|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566340|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566341|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566342|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566343|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566344|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566345|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566346|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566422|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
566347|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566348|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566349|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566350|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566351|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566352|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566353|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566354|NCT00603278|E6|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566355|NCT00603278|E5|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566356|NCT00603278|E4|Reported Event|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566357|NCT00603278|E3|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566358|NCT00603278|E2|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
566359|NCT00603278|E1|Reported Event|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
566360|NCT00603265|B4|Baseline|Total|Total of all reporting groups
566361|NCT00603265|B3|Baseline|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566362|NCT00603265|B2|Baseline|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566363|NCT00603265|B1|Baseline|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566364|NCT00603265|P3|Participant Flow|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566365|NCT00603265|P2|Participant Flow|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566366|NCT00603265|P1|Participant Flow|ADL5859|2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566367|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566368|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566369|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566370|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566371|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566372|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566373|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566374|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566377|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566378|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566379|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566380|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566381|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566382|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566383|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566384|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566385|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566386|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566387|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566388|NCT00603265|E3|Reported Event|Placebo|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
566389|NCT00603265|E2|Reported Event|Duloxetine|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
566390|NCT00603265|E1|Reported Event|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
566391|NCT00603239|B3|Baseline|Total|Total of all reporting groups
566392|NCT00603239|B2|Baseline|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566393|NCT00603239|B1|Baseline|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566394|NCT00603239|P2|Participant Flow|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566395|NCT00603239|P1|Participant Flow|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566396|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566397|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566398|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566399|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566400|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566401|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566402|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566403|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566404|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566405|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566406|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566407|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566408|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566409|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566410|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566411|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566412|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566413|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566414|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566415|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566416|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566417|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
566418|NCT00603239|E2|Reported Event|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
566428|NCT00603044|B1|Baseline|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566429|NCT00603044|P2|Participant Flow|No Treatment|Subjects in this arm received no treatment.
566430|NCT00603044|P1|Participant Flow|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566431|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
566432|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566433|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
566434|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566435|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
566436|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566437|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
566438|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566439|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
566440|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566441|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
566442|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566443|NCT00603044|E2|Reported Event|No Treatment|Subjects in this arm received no treatment.
566444|NCT00603044|E1|Reported Event|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
566445|NCT00603018|B1|Baseline|1/Recovered Anorevia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
566446|NCT00603018|P1|Participant Flow|Participants Recovered From Anorexia Before + After Fluoxetine|"Participants recovered from anorexia~Fluoxetine: before 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
566447|NCT00603018|O2|Outcome|1/Recovered Anorexia After 8 Weeks of Treatment|"1/Recovered anorexia after 8 weeks of treatment~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
566448|NCT00603018|O1|Outcome|1/Recovered Anorexia Before 8 Weeks of Treatment|"1/Recovered anorexia before 8 weeks of treatment~Baseline"
566449|NCT00603018|E1|Reported Event|1/Recovered Anorexia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
566450|NCT00602979|B6|Baseline|Total|Total of all reporting groups
566451|NCT00602979|B5|Baseline|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566452|NCT00602979|B4|Baseline|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566453|NCT00602979|B3|Baseline|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
566454|NCT00602979|B2|Baseline|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
566455|NCT00602979|B1|Baseline|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
566456|NCT00602979|P5|Participant Flow|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566457|NCT00602979|P4|Participant Flow|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566458|NCT00602979|P3|Participant Flow|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
566459|NCT00602979|P2|Participant Flow|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
566460|NCT00602979|P1|Participant Flow|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
566461|NCT00602979|O5|Outcome|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566462|NCT00602979|O4|Outcome|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566463|NCT00602979|O3|Outcome|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
566464|NCT00602979|O2|Outcome|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
566465|NCT00602979|O1|Outcome|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
566466|NCT00602979|E5|Reported Event|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566467|NCT00602979|E4|Reported Event|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
566468|NCT00602979|E3|Reported Event|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
566469|NCT00602979|E2|Reported Event|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
566470|NCT00602979|E1|Reported Event|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
566471|NCT00602953|B6|Baseline|Total|Total of all reporting groups
566472|NCT00602953|B5|Baseline|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566473|NCT00602953|B4|Baseline|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566474|NCT00602953|B3|Baseline|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566475|NCT00602953|B2|Baseline|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566476|NCT00602953|B1|Baseline|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566477|NCT00602953|P5|Participant Flow|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566478|NCT00602953|P4|Participant Flow|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566479|NCT00602953|P3|Participant Flow|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566480|NCT00602953|P2|Participant Flow|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566481|NCT00602953|P1|Participant Flow|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566482|NCT00602953|O5|Outcome|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566483|NCT00602953|O4|Outcome|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566484|NCT00602953|O3|Outcome|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566485|NCT00602953|O2|Outcome|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566486|NCT00602953|O1|Outcome|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566487|NCT00602953|O5|Outcome|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566488|NCT00602953|O4|Outcome|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566489|NCT00602953|O3|Outcome|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566490|NCT00602953|O2|Outcome|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566491|NCT00602953|O1|Outcome|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566492|NCT00602953|O5|Outcome|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566493|NCT00602953|O4|Outcome|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566494|NCT00602953|O3|Outcome|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566495|NCT00602953|O2|Outcome|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566496|NCT00602953|O1|Outcome|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566497|NCT00602953|O5|Outcome|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566498|NCT00602953|O4|Outcome|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566499|NCT00602953|O3|Outcome|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566500|NCT00602953|O2|Outcome|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566501|NCT00602953|O1|Outcome|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566502|NCT00602953|E5|Reported Event|Type 1 Diabetes|"Patients with type 1 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566503|NCT00602953|E4|Reported Event|Type 2 Diabetes|"Patients with type 2 diabetes.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566504|NCT00602953|E3|Reported Event|Overweight|"Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566505|NCT00602953|E2|Reported Event|Pre-diabetes|"Impaired fasting glucose of impaired glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566506|NCT00602953|E1|Reported Event|Healthy Volunteers|"Normal weight and normal glucose tolerance.~No intervention planned.: This is a cross-sectional observational study, no intervention is planned."
566507|NCT00602927|B3|Baseline|Total|Total of all reporting groups
566508|NCT00602927|B2|Baseline|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566509|NCT00602927|B1|Baseline|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566510|NCT00602927|P2|Participant Flow|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566511|NCT00602927|P1|Participant Flow|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566512|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566513|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566514|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566515|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566516|NCT00602927|E2|Reported Event|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566517|NCT00602927|E1|Reported Event|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
566518|NCT00602836|B1|Baseline|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
566519|NCT00602836|P1|Participant Flow|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
566520|NCT00602836|O1|Outcome|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
566521|NCT00602836|E1|Reported Event|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
566522|NCT00602797|B1|Baseline|Treatment (Vinorelbine Tartrate, Paclitaxel)|"Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Vinorelbine Tartrate: Given IV"
566523|NCT00602797|P1|Participant Flow|Treatment|This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
566524|NCT00602797|O1|Outcome|Treatment Group|Patients >70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
566525|NCT00602797|O1|Outcome|Treatment|This is a non-randomized, single-arm, phase II study of vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer. Vinorelbine (22.5 mg/m2) and paclitaxel (40 mg/m2) were given weekly for six weeks followed by a two-week break. Each patient received a maximum of two cycles (12 doses) of chemotherapy. All patients received standard premedication for nausea and hypersensitivity prophylaxis per individual institutional guidelines. Quality of life (QoL) was assessed at baseline, week 9, and week 17 using the Functional Assessment of Cancer Therapy lung cancer subscale instrument (FACT-L).
566526|NCT00602797|O1|Outcome|Treatment Group|Patients >70 years with advanced NSCLC treated with weekly paclitaxel and vinorelbine
566527|NCT00602797|E1|Reported Event|Treatment (Vinorelbine Tartrate, Paclitaxel)|"Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Vinorelbine Tartrate: Given IV"
566528|NCT00602771|B3|Baseline|Total|Total of all reporting groups
566529|NCT00602771|B2|Baseline|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
566530|NCT00602771|B1|Baseline|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
566531|NCT00602771|P2|Participant Flow|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
566532|NCT00602771|P1|Participant Flow|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
566533|NCT00602771|O2|Outcome|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
567287|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
566534|NCT00602771|O1|Outcome|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
566535|NCT00602771|E2|Reported Event|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
566536|NCT00602771|E1|Reported Event|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
566537|NCT00602641|B3|Baseline|Total|Total of all reporting groups
566538|NCT00602641|B2|Baseline|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~lenalidomide: Given PO"
566539|NCT00602641|B1|Baseline|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~thalidomide: Given PO"
566540|NCT00602641|P2|Participant Flow|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan 5 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
566541|NCT00602641|P1|Participant Flow|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan 9 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression."
566542|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
566543|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
566544|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
566545|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
566546|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
566547|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
566548|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
566549|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
566714|NCT00601965|E4|Reported Event|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
566891|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566550|NCT00602641|E2|Reported Event|mPR-R|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
566551|NCT00602641|E1|Reported Event|MPT-T|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
566552|NCT00602537|B3|Baseline|Total|Total of all reporting groups
566553|NCT00602537|B2|Baseline|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
566554|NCT00602537|B1|Baseline|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
566555|NCT00602537|P2|Participant Flow|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
566556|NCT00602537|P1|Participant Flow|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
566557|NCT00602537|O2|Outcome|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
566558|NCT00602537|O1|Outcome|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
566559|NCT00602537|O2|Outcome|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
566560|NCT00602537|O1|Outcome|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
566561|NCT00602537|E2|Reported Event|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
566562|NCT00602537|E1|Reported Event|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
566563|NCT00602472|B3|Baseline|Total|Total of all reporting groups
566564|NCT00602472|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566565|NCT00602472|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
566566|NCT00602472|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566567|NCT00602472|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
566568|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566569|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566570|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566571|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566572|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566573|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566574|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566575|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566576|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566577|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566578|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566579|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566580|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566581|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566582|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566583|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566584|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566585|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566586|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566587|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566588|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566589|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566590|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566591|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566592|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566593|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566594|NCT00602472|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
566595|NCT00602472|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
566596|NCT00602459|B5|Baseline|Total|Total of all reporting groups
566597|NCT00602459|B4|Baseline|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
566598|NCT00602459|B3|Baseline|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
566599|NCT00602459|B2|Baseline|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
566600|NCT00602459|B1|Baseline|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
566601|NCT00602459|P4|Participant Flow|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
566602|NCT00602459|P3|Participant Flow|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
566603|NCT00602459|P2|Participant Flow|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
566604|NCT00602459|P1|Participant Flow|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
566605|NCT00602459|O2|Outcome|Arm D, FCR+L in Del(11q22.3)|Patients who have del(11q22.3)receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
566606|NCT00602459|O1|Outcome|Arm C2, FCR in Del(11q22.3)|Participants who have del(11q22.3) receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
566607|NCT00602459|O3|Outcome|Arm C1, FCR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (C) (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
566608|NCT00602459|O2|Outcome|Arm B, FR+L in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
566609|NCT00602459|O1|Outcome|Arm A, FR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
566610|NCT00602459|O2|Outcome|Arm D, FCR+L in Del(11q22.3)|Patients who have del(11q22.3)receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
566611|NCT00602459|O1|Outcome|Arm C2, FCR in Del(11q22.3)|Participants who have del(11q22.3) receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
566715|NCT00601965|E3|Reported Event|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
567288|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
566612|NCT00602459|O3|Outcome|Arm C1, FCR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (C) (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
566613|NCT00602459|O2|Outcome|Arm B, FR+L in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
566614|NCT00602459|O1|Outcome|Arm A, FR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
566615|NCT00602459|E4|Reported Event|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
566616|NCT00602459|E3|Reported Event|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
566617|NCT00602459|E2|Reported Event|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
566618|NCT00602459|E1|Reported Event|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
566619|NCT00602446|B1|Baseline|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
566620|NCT00602446|P1|Participant Flow|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
566621|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
566622|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
566623|NCT00602446|E1|Reported Event|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
566624|NCT00602420|B3|Baseline|Total|Total of all reporting groups
566625|NCT00602420|B2|Baseline|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
566626|NCT00602420|B1|Baseline|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
566627|NCT00602420|P2|Participant Flow|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
566628|NCT00602420|P1|Participant Flow|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
566629|NCT00602420|O2|Outcome|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
566630|NCT00602420|O1|Outcome|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
566631|NCT00602420|E2|Reported Event|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
566632|NCT00602420|E1|Reported Event|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
566633|NCT00602355|B4|Baseline|Total|Total of all reporting groups
566634|NCT00602355|B3|Baseline|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566690|NCT00602043|O2|Outcome|Diagnostic FES: Patients With FES Negative Sites of Disease|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan."
566635|NCT00602355|B2|Baseline|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566636|NCT00602355|B1|Baseline|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566637|NCT00602355|P3|Participant Flow|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566638|NCT00602355|P2|Participant Flow|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566639|NCT00602355|P1|Participant Flow|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566640|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566641|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566642|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566643|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566644|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566645|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566646|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566647|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566648|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566649|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566650|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566651|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566652|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566653|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566654|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566655|NCT00602355|E3|Reported Event|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
566656|NCT00602355|E2|Reported Event|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566657|NCT00602355|E1|Reported Event|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
566658|NCT00602290|B4|Baseline|Total|Total of all reporting groups
566712|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
566659|NCT00602290|B3|Baseline|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
566660|NCT00602290|B2|Baseline|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566661|NCT00602290|B1|Baseline|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566662|NCT00602290|P3|Participant Flow|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
566663|NCT00602290|P2|Participant Flow|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566664|NCT00602290|P1|Participant Flow|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566665|NCT00602290|O3|Outcome|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
566666|NCT00602290|O2|Outcome|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566667|NCT00602290|O1|Outcome|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566668|NCT00602290|O3|Outcome|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
566669|NCT00602290|O2|Outcome|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566670|NCT00602290|O1|Outcome|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566671|NCT00602290|E3|Reported Event|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
566672|NCT00602290|E2|Reported Event|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566673|NCT00602290|E1|Reported Event|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
566674|NCT00602225|B1|Baseline|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566675|NCT00602225|P1|Participant Flow|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566676|NCT00602225|O1|Outcome|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566677|NCT00602225|O1|Outcome|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566678|NCT00602225|O1|Outcome|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566679|NCT00602225|O1|Outcome|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566680|NCT00602225|O1|Outcome|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566681|NCT00602225|O1|Outcome|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566682|NCT00602225|O1|Outcome|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566683|NCT00602225|O1|Outcome|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566684|NCT00602225|O1|Outcome|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566685|NCT00602225|O1|Outcome|Arm I: Filgrastim + Clofarabine + Cytarabine (GCLAC)|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566686|NCT00602225|E1|Reported Event|Arm I|"See Detailed Description~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given subcutaneously"
566687|NCT00602043|B1|Baseline|First Line Endocrine Therapy for a Stage IV Disease|
566688|NCT00602043|P1|Participant Flow|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
566689|NCT00602043|O1|Outcome|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
566713|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566892|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566691|NCT00602043|O1|Outcome|Diagnostic (FES): Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan."
566692|NCT00602043|O2|Outcome|Diagnostic FES: Patients With FES Negative Sites of Disease|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan."
566693|NCT00602043|O1|Outcome|Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.~laboratory biomarker analysis: Correlative studies"
566694|NCT00602043|O2|Outcome|Diagnostic FES: Patients With FES Negative Sites of Disease|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan."
566695|NCT00602043|O1|Outcome|Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.~laboratory biomarker analysis: Correlative studies"
566696|NCT00602043|E1|Reported Event|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
566697|NCT00601965|B5|Baseline|Total|Total of all reporting groups
566698|NCT00601965|B4|Baseline|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
566699|NCT00601965|B3|Baseline|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566700|NCT00601965|B2|Baseline|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
566701|NCT00601965|B1|Baseline|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566702|NCT00601965|P4|Participant Flow|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
566703|NCT00601965|P3|Participant Flow|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566704|NCT00601965|P2|Participant Flow|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
566705|NCT00601965|P1|Participant Flow|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566706|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
566707|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566708|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
566709|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566710|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
566711|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566716|NCT00601965|E2|Reported Event|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
566717|NCT00601965|E1|Reported Event|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
566718|NCT00601952|B3|Baseline|Total|Total of all reporting groups
566719|NCT00601952|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
566720|NCT00601952|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
566721|NCT00601952|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
566722|NCT00601952|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
566723|NCT00601952|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
566724|NCT00601952|O1|Outcome|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
566725|NCT00601952|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
566726|NCT00601952|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
566727|NCT00601926|B1|Baseline|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
566728|NCT00601926|P1|Participant Flow|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
566729|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
566730|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
566731|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
566732|NCT00601926|E1|Reported Event|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
566733|NCT00601900|B3|Baseline|Total|Total of all reporting groups
566734|NCT00601900|B2|Baseline|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566735|NCT00601900|B1|Baseline|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566736|NCT00601900|P2|Participant Flow|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566737|NCT00601900|P1|Participant Flow|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566738|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566739|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566893|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566740|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566741|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566742|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566743|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566744|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566745|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566746|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566747|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566748|NCT00601900|E2|Reported Event|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566749|NCT00601900|E1|Reported Event|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
566750|NCT00601835|B3|Baseline|Total|Total of all reporting groups
566751|NCT00601835|B2|Baseline|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
566752|NCT00601835|B1|Baseline|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
566753|NCT00601835|P2|Participant Flow|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
566754|NCT00601835|P1|Participant Flow|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
566755|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
566756|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
566757|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
566758|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
566759|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
566760|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
566761|NCT00601835|E2|Reported Event|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
566762|NCT00601835|E1|Reported Event|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
566763|NCT00601796|B1|Baseline|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
566764|NCT00601796|P1|Participant Flow|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
566783|NCT00601731|P4|Participant Flow|Canada Control|Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
566784|NCT00601731|P3|Participant Flow|Canada Sites|Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
566894|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566765|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
566766|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
566767|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
566768|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
566769|NCT00601796|E1|Reported Event|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
566770|NCT00601731|B13|Baseline|Total|Total of all reporting groups
566771|NCT00601731|B12|Baseline|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
566772|NCT00601731|B11|Baseline|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566773|NCT00601731|B10|Baseline|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566774|NCT00601731|B9|Baseline|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566775|NCT00601731|B8|Baseline|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566776|NCT00601731|B7|Baseline|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
566777|NCT00601731|B6|Baseline|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
566778|NCT00601731|B5|Baseline|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
566779|NCT00601731|B4|Baseline|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566780|NCT00601731|B3|Baseline|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566781|NCT00601731|B2|Baseline|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566782|NCT00601731|B1|Baseline|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566857|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
566785|NCT00601731|P2|Participant Flow|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
566786|NCT00601731|P1|Participant Flow|UK Site|UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
566787|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
566788|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566789|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566790|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566791|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566792|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
566793|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
566794|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
566795|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566796|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566797|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566798|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566799|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
566800|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566801|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566802|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566803|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566804|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
566805|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
566806|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
566807|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566808|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566809|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566810|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
567339|NCT00600743|O4|Outcome|Normal_4mg Drug|Eat normally 4 mg dose drug
566811|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
566812|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566813|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566814|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566815|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566816|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
566817|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
566818|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
566819|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566820|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566821|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566822|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566823|NCT00601731|E12|Reported Event|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
566824|NCT00601731|E11|Reported Event|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566825|NCT00601731|E10|Reported Event|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566826|NCT00601731|E9|Reported Event|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
566827|NCT00601731|E8|Reported Event|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566828|NCT00601731|E7|Reported Event|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
566829|NCT00601731|E6|Reported Event|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
566830|NCT00601731|E5|Reported Event|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
566831|NCT00601731|E4|Reported Event|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
566832|NCT00601731|E3|Reported Event|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566833|NCT00601731|E2|Reported Event|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566834|NCT00601731|E1|Reported Event|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
566858|NCT00601640|E3|Reported Event|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
566859|NCT00601640|E2|Reported Event|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
566860|NCT00601640|E1|Reported Event|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
566835|NCT00601718|B1|Baseline|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
566836|NCT00601718|P1|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
566837|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
566838|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
566839|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
566840|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
566841|NCT00601718|E1|Reported Event|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
566842|NCT00601640|B4|Baseline|Total|Total of all reporting groups
566843|NCT00601640|B3|Baseline|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
566844|NCT00601640|B2|Baseline|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
566845|NCT00601640|B1|Baseline|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
566846|NCT00601640|P3|Participant Flow|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
566847|NCT00601640|P2|Participant Flow|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
566848|NCT00601640|P1|Participant Flow|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
566849|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
566850|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
566851|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
566852|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90
566853|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
566854|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90
566855|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
566856|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
566861|NCT00601627|B1|Baseline|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566862|NCT00601627|P1|Participant Flow|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566863|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566864|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566865|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566866|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566867|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566868|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
566869|NCT00601627|E1|Reported Event|Panitumumab|6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
566870|NCT00601523|B3|Baseline|Total|Total of all reporting groups
566871|NCT00601523|B2|Baseline|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566872|NCT00601523|B1|Baseline|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566873|NCT00601523|P2|Participant Flow|Patients From 248.636|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.636 (NCT00558025) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
566874|NCT00601523|P1|Participant Flow|Patients From 248.524|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.524 (NCT00479401) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
566875|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566876|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566877|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566878|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566879|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566880|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566881|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566882|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566883|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566884|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566885|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566886|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566887|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566888|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566889|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566895|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566896|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566897|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566898|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566899|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566900|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566901|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566902|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566903|NCT00601523|E2|Reported Event|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
566904|NCT00601523|E1|Reported Event|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
566905|NCT00601458|B4|Baseline|Total|Total of all reporting groups
566906|NCT00601458|B3|Baseline|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
566907|NCT00601458|B2|Baseline|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
566908|NCT00601458|B1|Baseline|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
566909|NCT00601458|P3|Participant Flow|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
566910|NCT00601458|P2|Participant Flow|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
566911|NCT00601458|P1|Participant Flow|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
566912|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
566913|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
566914|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
566915|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
566916|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
566917|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
566918|NCT00601458|E3|Reported Event|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
566919|NCT00601458|E2|Reported Event|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
566920|NCT00601458|E1|Reported Event|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
566921|NCT00601419|B1|Baseline|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566922|NCT00601419|P1|Participant Flow|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566923|NCT00601419|O2|Outcome|Participants Without ACTH Deficiency|Participants without ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566924|NCT00601419|O1|Outcome|Participants With ACTH Deficiency|Participants with ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566925|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566926|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566927|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566928|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566929|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566930|NCT00601419|O4|Outcome|>0.084 mg/kg/Week|Participants taking an initial dose of more than 0.084 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
566931|NCT00601419|O3|Outcome|>=0.042 mg/kg/Week and <=0.084 mg/kg/Week|Participants taking an initial dose of 0.042 mg/kg/week or more and 0.084 mg/kg/week or less of somatropin for adult growth hormone deficiency according to Japanese package insert.
566932|NCT00601419|O2|Outcome|>=0.021 mg/kg/Week and <0.042 mg/kg/Week|Participants taking an initial dose of 0.021 mg/kg/week or more and less than 0.042 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
566933|NCT00601419|O1|Outcome|<0.021 mg/kg/Week|Participants taking an initial dose of less than 0.021 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
566934|NCT00601419|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566935|NCT00601419|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566936|NCT00601419|O2|Outcome|Participants Without TSH Deficiency|Participants without TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566937|NCT00601419|O1|Outcome|Participants With TSH Deficiency|Participants with TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566938|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566939|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566940|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566941|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566942|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566943|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566944|NCT00601419|E1|Reported Event|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
566945|NCT00601367|B1|Baseline|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.~Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.~flibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati"
566946|NCT00601367|P1|Participant Flow|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site."
566947|NCT00601367|O1|Outcome|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
566948|NCT00601367|E1|Reported Event|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
566949|NCT00601354|B3|Baseline|Total|Total of all reporting groups
566950|NCT00601354|B2|Baseline|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
566951|NCT00601354|B1|Baseline|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
566952|NCT00601354|P2|Participant Flow|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
566953|NCT00601354|P1|Participant Flow|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
566954|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
567005|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
566955|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
566956|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
566957|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
566958|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
566959|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
566960|NCT00601354|E2|Reported Event|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
566961|NCT00601354|E1|Reported Event|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
566962|NCT00601250|B3|Baseline|Total|Total of all reporting groups
566963|NCT00601250|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566964|NCT00601250|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
566965|NCT00601250|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566966|NCT00601250|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
566967|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566968|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566969|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566970|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566971|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566972|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566973|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566974|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566975|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566976|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566977|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566978|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566979|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566980|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566981|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566982|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566983|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566984|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566985|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566986|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566987|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566988|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566989|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566990|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566991|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566992|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566993|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566994|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566995|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566996|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
566997|NCT00601250|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
566998|NCT00601250|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
566999|NCT00601172|B3|Baseline|Total|Total of all reporting groups
567000|NCT00601172|B2|Baseline|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567001|NCT00601172|B1|Baseline|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567002|NCT00601172|P2|Participant Flow|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567003|NCT00601172|P1|Participant Flow|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 milligram [mg] twice daily [BID] orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567004|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567340|NCT00600743|O3|Outcome|Normal_2mg Drug|Eat normally 2 mg dose drug
567006|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567007|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567008|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567009|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567010|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567011|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567012|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567013|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567014|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567015|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567016|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567017|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567018|NCT00601172|O1|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567019|NCT00601172|O1|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567020|NCT00601172|O1|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567021|NCT00601172|O1|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567022|NCT00601172|O1|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567023|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567024|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567025|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567026|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567027|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567028|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567029|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567030|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567031|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567032|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567033|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567034|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567035|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567036|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567037|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567341|NCT00600743|O2|Outcome|Normal_1mg Drug|Eat normally 1 mg dose drug
567038|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567039|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567040|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567041|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567042|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567043|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567044|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567045|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567046|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567047|NCT00601172|O2|Outcome|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567048|NCT00601172|O1|Outcome|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567049|NCT00601172|E2|Reported Event|Casopitant 90 mg|Eligible participants received casopitant 90 mg, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567050|NCT00601172|E1|Reported Event|Placebo|Eligible participants received placebo to match casopitant, via IV route, (along with Ondansetron 8 mg BID orally and dexamethasone 8 mg IV) on Day 1 of each cycle over 30 minutes.
567051|NCT00601146|B1|Baseline|Low-dose CT Screening|Annual low-dose chest CT screening
567052|NCT00601146|P1|Participant Flow|Low-dose CT Screening|Annual low-dose chest CT screening
567053|NCT00601146|O1|Outcome|Low-dose CT Screening|Annual low-dose chest CT screening
567054|NCT00601146|E1|Reported Event|Low-dose CT Screening|Annual low-dose chest CT screening
567055|NCT00601107|B5|Baseline|Total|Total of all reporting groups
567056|NCT00601107|B4|Baseline|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
567057|NCT00601107|B3|Baseline|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
567058|NCT00601107|B2|Baseline|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
567059|NCT00601107|B1|Baseline|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
567060|NCT00601107|P4|Participant Flow|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
567061|NCT00601107|P3|Participant Flow|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
567062|NCT00601107|P2|Participant Flow|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
567063|NCT00601107|P1|Participant Flow|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
567064|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
567065|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
567066|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
567067|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
567068|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
567069|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
567070|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
567071|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
567072|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
567073|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
567074|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
567075|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
567076|NCT00601107|E4|Reported Event|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
567077|NCT00601107|E3|Reported Event|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
567078|NCT00601107|E2|Reported Event|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
567079|NCT00601107|E1|Reported Event|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
567080|NCT00600938|B3|Baseline|Total|Total of all reporting groups
567081|NCT00600938|B2|Baseline|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567082|NCT00600938|B1|Baseline|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567083|NCT00600938|P4|Participant Flow|ICL to DFO (Deferasirox to Deferoxamine)|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567084|NCT00600938|P3|Participant Flow|DFO to ICL (Deferoxamine to Deferasirox)|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567085|NCT00600938|P2|Participant Flow|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567086|NCT00600938|P1|Participant Flow|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567087|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567088|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567089|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567090|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567091|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567092|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567093|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567094|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567095|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567096|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567097|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567098|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567099|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567100|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567101|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567102|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567103|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567104|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567105|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567106|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567107|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567108|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567109|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567110|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567111|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567112|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567113|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567114|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567115|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567116|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567117|NCT00600938|O3|Outcome|Extension; DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567118|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567119|NCT00600938|O1|Outcome|Extension : ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567120|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567121|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567122|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567123|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
567124|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567125|NCT00600938|O2|Outcome|Core; Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
567126|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
567127|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
567128|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
567129|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567130|NCT00600938|O1|Outcome|Core; Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
567131|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
567132|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
567133|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
567134|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
567135|NCT00600938|O2|Outcome|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567136|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
567137|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
567138|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
567139|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 months.
567140|NCT00600938|O1|Outcome|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 months.
567141|NCT00600938|E6|Reported Event|Extension Phase - ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
567142|NCT00600938|E5|Reported Event|Extension Phase - DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
567143|NCT00600938|E4|Reported Event|Extension Phase - DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567144|NCT00600938|E3|Reported Event|Extension Phase - ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567145|NCT00600938|E2|Reported Event|Core Phase - DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
567146|NCT00600938|E1|Reported Event|Core Phase - ICL670|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
567147|NCT00600886|B3|Baseline|Total|Total of all reporting groups
567148|NCT00600886|B2|Baseline|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
567149|NCT00600886|B1|Baseline|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
567150|NCT00600886|P2|Participant Flow|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
567280|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
569340|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
567151|NCT00600886|P1|Participant Flow|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
567152|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567153|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567154|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567155|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567156|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567157|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567158|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567159|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567160|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567161|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567162|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567163|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567164|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567165|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567166|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567167|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567168|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567169|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567170|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567171|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567172|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
569341|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
567173|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567174|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
567175|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
567176|NCT00600886|O3|Outcome|Octreotide LAR 30 mg|Patients in this arm received Octreotide LAR 30 mg injection prior to PK sample collection.
567177|NCT00600886|O2|Outcome|Octreotide LAR 20 mg|Patients in this arm received Octreotide LAR 20 mg injection prior to PK sample collection.
567178|NCT00600886|O1|Outcome|Octreotide LAR 10mg|Patients in this arm received Octreotide LAR 10 mg injection prior to PK sample collection.
567179|NCT00600886|O3|Outcome|Pasireotide LAR 60mg|Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
567180|NCT00600886|O2|Outcome|Pasireotide LAR 40 mg|Patients in this arm received Pasireotide LAR 40 mg injection prior to PK sample collection.
567181|NCT00600886|O1|Outcome|Pasireotide LAR 20 mg|Patients in this arm received Pasireotide LAR 20 mg injection prior to PK sample collection.
567182|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567183|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567184|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567185|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567186|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567187|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567188|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567189|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567190|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567191|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567192|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567193|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567194|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567195|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567281|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567282|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567283|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567196|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
567197|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
567198|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
567199|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
567200|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
567201|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
567202|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
567203|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
567204|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
567205|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
567206|NCT00600886|E6|Reported Event|Crossed Over to Pasireotide LAR - up to EOS|"Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.~Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
567207|NCT00600886|E5|Reported Event|Pasireotide LAR - up to EOS|"Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.~Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
567208|NCT00600886|E4|Reported Event|Crossed Over to Octreotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.
567209|NCT00600886|E3|Reported Event|Crossed Over to Pasireotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.
567210|NCT00600886|E2|Reported Event|Octreotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included.
567211|NCT00600886|E1|Reported Event|Pasireotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.
567212|NCT00600821|B3|Baseline|Total|Total of all reporting groups
567213|NCT00600821|B2|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567214|NCT00600821|B1|Baseline|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567215|NCT00600821|P2|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567216|NCT00600821|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg*minute/milliliter (mg*min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567217|NCT00600821|O2|Outcome|Bevacizumab+ Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
567218|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
567219|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567220|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567221|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567222|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567223|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567224|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567225|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567226|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567227|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567228|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567229|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567230|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567231|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567232|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567233|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567234|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567284|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567285|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567286|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567235|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567236|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567237|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567238|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567239|NCT00600821|E2|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
567240|NCT00600821|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
567241|NCT00600756|B3|Baseline|Total|Total of all reporting groups
567242|NCT00600756|B2|Baseline|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
567243|NCT00600756|B1|Baseline|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567244|NCT00600756|P2|Participant Flow|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
567245|NCT00600756|P1|Participant Flow|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567246|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567247|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567248|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567249|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567250|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567251|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567252|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567253|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567254|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567255|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567256|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567257|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567258|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567259|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567260|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567261|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567262|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567263|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567264|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567265|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567266|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567267|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567268|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567269|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567270|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567271|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567272|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567273|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567274|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567275|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567276|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567277|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567278|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567279|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
569342|NCT00594425|O3|Outcome|Vehicle PDT|
567289|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567290|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567291|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567292|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567293|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567294|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567295|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567296|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567297|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567298|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567299|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567300|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567301|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567302|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567303|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567304|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567305|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567306|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
567307|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567308|NCT00600756|E2|Reported Event|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
567309|NCT00600756|E1|Reported Event|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
567310|NCT00600743|B5|Baseline|Total|Total of all reporting groups
567311|NCT00600743|B4|Baseline|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
567312|NCT00600743|B3|Baseline|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
567313|NCT00600743|B2|Baseline|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
567314|NCT00600743|B1|Baseline|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
567315|NCT00600743|P4|Participant Flow|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
567316|NCT00600743|P3|Participant Flow|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
567317|NCT00600743|P2|Participant Flow|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
567318|NCT00600743|P1|Participant Flow|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
567319|NCT00600743|O8|Outcome|Normal_4 mg Dose Placebo|Eat normally 4 mg dose placebo
567320|NCT00600743|O7|Outcome|Normal_2 mg Dose Placebo|Eat normally 2 mg dose placebo
567321|NCT00600743|O6|Outcome|Normal 1 mg Dose Placebo|Eat normally 1 mg dose placebo
567322|NCT00600743|O5|Outcome|Binge - 4mg Placebo|Non-bulimic controls instruction to binge eat - placebo
567323|NCT00600743|O4|Outcome|Normal_4mg Drug|Eat normally 4 mg dose drug
567324|NCT00600743|O3|Outcome|Normal_2mg Drug|Eat normally 2 mg dose drug
567325|NCT00600743|O2|Outcome|Normal_1mg Drug|Eat normally 1 mg dose drug
567326|NCT00600743|O1|Outcome|Binge_4mg Drug|Non-bulimic controls Instruction to binge eat (7 subjects) drug
567327|NCT00600743|O8|Outcome|Normal_4mg Placebo|Normal_4mg_dose placebo
567328|NCT00600743|O7|Outcome|Normal 2mg_placebo|Normal 2mg_dose_placebo
567329|NCT00600743|O6|Outcome|Normal 1 mg Placebo|Normal 1 mg dose placebo
567330|NCT00600743|O5|Outcome|Binge - 4mg Plc|binge - 4mg placebo
567331|NCT00600743|O4|Outcome|Normal_4mg d|Normal_4mg drug
567332|NCT00600743|O3|Outcome|Normal_2mg d|Normal_2mg drug
567333|NCT00600743|O2|Outcome|Normal_1mg d|Normal_1mg drug
567334|NCT00600743|O1|Outcome|Binge_4mg d|Binge_4mg drug
567335|NCT00600743|O8|Outcome|Normal_4 mg Dose Placebo|Eat normally 4 mg dose placebo
567336|NCT00600743|O7|Outcome|Normal_2 mg Dose Placebo|Eat normally 2 mg dose placebo
567337|NCT00600743|O6|Outcome|Normal 1 mg Dose Placebo|Eat normally 1 mg dose placebo
567338|NCT00600743|O5|Outcome|Binge - 4mg Placebo|Non-bulimic controls instruction to binge eat - placebo
567342|NCT00600743|O1|Outcome|Binge_4mg Drug|Non-bulimic controls Instruction to binge eat (7 subjects) drug
567343|NCT00600743|E1|Reported Event|Normal|Normal control group
567344|NCT00600704|B3|Baseline|Total|Total of all reporting groups
567345|NCT00600704|B2|Baseline|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
567346|NCT00600704|B1|Baseline|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
567347|NCT00600704|P2|Participant Flow|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
567348|NCT00600704|P1|Participant Flow|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
567349|NCT00600704|O2|Outcome|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
567350|NCT00600704|O1|Outcome|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
567351|NCT00600704|E2|Reported Event|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
567352|NCT00600704|E1|Reported Event|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
567353|NCT00600613|B1|Baseline|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
567354|NCT00600613|P1|Participant Flow|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
567355|NCT00600613|O1|Outcome|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
567356|NCT00600613|E1|Reported Event|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
567357|NCT00600353|B3|Baseline|Total|Total of all reporting groups
567358|NCT00600353|B2|Baseline|Group B Lymphoma|Includes patients with Hodgkin's Disease and Non-Hodgkin's lymphoma
567359|NCT00600353|B1|Baseline|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion~Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
567360|NCT00600353|P2|Participant Flow|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
567361|NCT00600353|P1|Participant Flow|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
567362|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
567363|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
567364|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
567365|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
567366|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
567367|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
567368|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
567369|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
567453|NCT00600119|B5|Baseline|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
567454|NCT00600119|B4|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
567370|NCT00600353|E2|Reported Event|Patients With Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
567371|NCT00600353|E1|Reported Event|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
567372|NCT00600171|B7|Baseline|Total|Total of all reporting groups
567373|NCT00600171|B6|Baseline|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567374|NCT00600171|B5|Baseline|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567375|NCT00600171|B4|Baseline|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567376|NCT00600171|B3|Baseline|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567377|NCT00600171|B2|Baseline|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567378|NCT00600171|B1|Baseline|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567379|NCT00600171|P6|Participant Flow|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567380|NCT00600171|P5|Participant Flow|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567381|NCT00600171|P4|Participant Flow|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567382|NCT00600171|P3|Participant Flow|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567383|NCT00600171|P2|Participant Flow|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567384|NCT00600171|P1|Participant Flow|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567385|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567386|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567387|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567388|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567389|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567390|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567391|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567392|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567393|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567394|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567395|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567396|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567397|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567398|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567399|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567400|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567401|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567402|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567403|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567404|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567405|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567406|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567407|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567408|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567409|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567410|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567455|NCT00600119|B3|Baseline|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
567456|NCT00600119|B2|Baseline|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
567457|NCT00600119|B1|Baseline|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
567411|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567412|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567413|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567414|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567415|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567416|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567417|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567418|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567419|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567420|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567421|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567422|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567423|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567424|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567425|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567426|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567427|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567428|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567429|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567430|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567458|NCT00600119|P6|Participant Flow|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
567459|NCT00600119|P5|Participant Flow|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
569343|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
567431|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567432|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567433|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567434|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567435|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567436|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567437|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567438|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567439|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567440|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567441|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567442|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567443|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567444|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567445|NCT00600171|E6|Reported Event|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567446|NCT00600171|E5|Reported Event|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567447|NCT00600171|E4|Reported Event|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567448|NCT00600171|E3|Reported Event|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567449|NCT00600171|E2|Reported Event|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567450|NCT00600171|E1|Reported Event|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
567451|NCT00600119|B7|Baseline|Total|Total of all reporting groups
567452|NCT00600119|B6|Baseline|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
569344|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
567460|NCT00600119|P4|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
567461|NCT00600119|P3|Participant Flow|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
567462|NCT00600119|P2|Participant Flow|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
567463|NCT00600119|P1|Participant Flow|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
567464|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
567465|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
567466|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
567467|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
567468|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
567469|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
567470|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
567471|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
567472|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
567473|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
567474|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
567475|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
567476|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
567477|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
567478|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
567479|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
567480|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
567481|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
567482|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
567483|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
567484|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
567485|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
567486|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
567487|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
567488|NCT00600119|E6|Reported Event|Placebo 50 mg|
567489|NCT00600119|E5|Reported Event|Placebo 5 mg|
567490|NCT00600119|E4|Reported Event|Placebo 25 mg|
567491|NCT00600119|E3|Reported Event|NKTR-118 50 mg|
567492|NCT00600119|E2|Reported Event|NKTR-118 5 mg|
567493|NCT00600119|E1|Reported Event|NKTR-118 25 mg|
567494|NCT00600106|B3|Baseline|Total|Total of all reporting groups
567495|NCT00600106|B2|Baseline|Placebo|1 mg placebo.
567496|NCT00600106|B1|Baseline|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567497|NCT00600106|P2|Participant Flow|Placebo|1 mg placebo.
567498|NCT00600106|P1|Participant Flow|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567499|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567500|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567501|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567502|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567503|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567504|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567505|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567506|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567507|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567508|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567509|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567510|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567511|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567512|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567513|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567514|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567515|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567516|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567517|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567518|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567519|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567520|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567521|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567522|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567523|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567524|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567525|NCT00600106|O2|Outcome|Placebo|1 mg placebo.
567526|NCT00600106|O1|Outcome|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567527|NCT00600106|E2|Reported Event|Placebo|1 mg placebo.
569345|NCT00594425|O3|Outcome|Vehicle PDT|
567528|NCT00600106|E1|Reported Event|Hormone Replacement Therapy|Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
567529|NCT00600080|B1|Baseline|All Subjects|All subjects crossed over to use each treatment for one week
567530|NCT00600080|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2.
567531|NCT00600080|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2.
567532|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
567533|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
567534|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
567535|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
567536|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
567537|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
567538|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
567539|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
567540|NCT00600080|E2|Reported Event|Nelfilcon A First Etafilcon A Second|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
567541|NCT00600080|E1|Reported Event|Etafilcon A First Nelfilcon A Second|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
567542|NCT00600067|B3|Baseline|Total|Total of all reporting groups
567543|NCT00600067|B2|Baseline|Active|PHEN/TPM 15/92
567544|NCT00600067|B1|Baseline|Placebo|
567545|NCT00600067|P2|Participant Flow|VI-0521|phentermine 15 mg/topiramate 92 mg
567546|NCT00600067|P1|Participant Flow|Placebo|
567547|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92mg
567548|NCT00600067|O1|Outcome|Placebo|
567549|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92 mg
567550|NCT00600067|O1|Outcome|Placebo|
567551|NCT00600067|E2|Reported Event|Active|PHEN/TPM 15/92
567552|NCT00600067|E1|Reported Event|Placebo|
567553|NCT00600028|B3|Baseline|Total|Total of all reporting groups
567554|NCT00600028|B2|Baseline|Placebo First, Then Thalidomide Drug|Placebo was administered in the first intervention period and Thalidomide 50 - 100 mg daily in the second intervention period(After washout period)
567555|NCT00600028|B1|Baseline|Drug Thalidomide First, Then Placebo|Drug thalidomide 50 - 100 mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
567556|NCT00600028|P2|Participant Flow|Placebo First, Then Thalidomide Drug|Placebo was administered in the first interventional period and Thalidomide 50-100mg daily in the second interventional period (after washout period).
567557|NCT00600028|P1|Participant Flow|Drug Thalidomide First, Then Placebo|Drug Thalidomide 50-100mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
567558|NCT00600028|O4|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
567559|NCT00600028|O3|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the first intervention period
567560|NCT00600028|O2|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
567561|NCT00600028|O1|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
567562|NCT00600028|O4|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
567563|NCT00600028|O3|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50 - 100 mg by mouth daily in the first intervention period
567564|NCT00600028|O2|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
567565|NCT00600028|O1|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
567566|NCT00600028|E2|Reported Event|Placebo|Placebo : Placebo 50-100 mg by mouth per day
567567|NCT00600028|E1|Reported Event|Thalidomide|Thalidomide : thalidomide 50 - 100 mg by mouth daily
567568|NCT00600015|B3|Baseline|Total|Total of all reporting groups
567569|NCT00600015|B2|Baseline|Placebo|Erlotinib + Placebo
567570|NCT00600015|B1|Baseline|Combination Therapy|Erlotinib + Sorafenib
567571|NCT00600015|P2|Participant Flow|Placebo|Erlotinib + Placebo
567572|NCT00600015|P1|Participant Flow|Combination Therapy|Erlotinib + Sorafenib
567573|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
567574|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
567575|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
567576|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
567577|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
567578|NCT00600015|E1|Reported Event|All Study Participants|"Reported SAEs and AEs for all study participants -~Combination Therapy: Erlotinib + Sorafenib Placebo: Erlotinib + Placebo"
567579|NCT00599924|B8|Baseline|Total|Total of all reporting groups
567580|NCT00599924|B7|Baseline|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567581|NCT00599924|B6|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567582|NCT00599924|B5|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567717|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567583|NCT00599924|B4|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567584|NCT00599924|B3|Baseline|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567585|NCT00599924|B2|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567586|NCT00599924|B1|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567587|NCT00599924|P7|Participant Flow|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567588|NCT00599924|P6|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567589|NCT00599924|P5|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567590|NCT00599924|P4|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567591|NCT00599924|P3|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567592|NCT00599924|P2|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567593|NCT00599924|P1|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567594|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
567595|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
567596|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567597|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567598|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567599|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
567600|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
567601|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567602|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567603|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567604|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567605|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567606|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567607|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567608|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567609|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567610|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567611|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
569346|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
567612|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567613|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567614|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567615|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567616|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567617|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567618|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567619|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567620|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567621|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567622|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567623|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567624|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567625|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567626|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567627|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567628|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567629|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567630|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567631|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567632|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567633|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567634|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567635|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567636|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567637|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567638|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567639|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567640|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567718|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567641|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567642|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567643|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567644|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567645|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567646|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567647|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567648|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567649|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567650|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567651|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567652|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567653|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567654|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567655|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567656|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567657|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567658|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567659|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567660|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567661|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567662|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567663|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567664|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567665|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567666|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567667|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567668|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567669|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567719|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567670|NCT00599924|E7|Reported Event|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567671|NCT00599924|E6|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
567672|NCT00599924|E5|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567673|NCT00599924|E4|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
567674|NCT00599924|E3|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567675|NCT00599924|E2|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567676|NCT00599924|E1|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
567677|NCT00599872|B3|Baseline|Total|Total of all reporting groups
567678|NCT00599872|B2|Baseline|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
567679|NCT00599872|B1|Baseline|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
567680|NCT00599872|P2|Participant Flow|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
567681|NCT00599872|P1|Participant Flow|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
567682|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
567683|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
567684|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
567685|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
567686|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
567687|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
567688|NCT00599872|O2|Outcome|Placebo|"Standardized Ragweed Allergenic Extract Placebo via the sublingual oral route~Placebo: Placebo, sublingual oral"
567689|NCT00599872|O1|Outcome|Ragweed Allergenic Extract|"Standardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units)~Standardized Ragweed Allergenic Extract: Standardized Ragweed Allergenic Extract, sublingual oral"
567690|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
567691|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
567692|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
567693|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
567694|NCT00599872|E2|Reported Event|Placebo|Placebo be administered once daily at 0.0 Units/Amb a 1
567695|NCT00599872|E1|Reported Event|Ragweed Allergenic Extract|Ragweed Allergenic extract administered once daily at 77.3 Units/Amb a 1.
567696|NCT00599755|B1|Baseline|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567697|NCT00599755|P1|Participant Flow|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567698|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567699|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567700|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567701|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567702|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567703|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567704|NCT00599755|E1|Reported Event|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
567705|NCT00599521|B3|Baseline|Total|Total of all reporting groups
567706|NCT00599521|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567707|NCT00599521|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
567708|NCT00599521|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567709|NCT00599521|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
567710|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567711|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567712|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567713|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567714|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567715|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567716|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567720|NCT00599521|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567721|NCT00599521|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
567722|NCT00599339|B1|Baseline|Overall|For this study, 5 groups of patients with different Parkinson’s disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
567723|NCT00599339|P1|Participant Flow|Overall|For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
567724|NCT00599339|O2|Outcome|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
567725|NCT00599339|O1|Outcome|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
567726|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567727|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567728|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567729|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567730|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567731|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567732|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567733|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567734|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567735|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567736|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
568175|NCT00597896|E2|Reported Event|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
567737|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567738|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567739|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567740|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567741|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567742|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567743|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567744|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567745|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567746|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567747|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567748|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567749|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567750|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567751|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567752|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567850|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
567753|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567754|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567755|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567756|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567757|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567758|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567759|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567760|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567761|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567762|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567763|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567764|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567765|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567766|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567767|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567768|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567851|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
567769|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567770|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567771|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567772|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567773|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567774|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567775|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567776|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567777|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567778|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567779|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567780|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567781|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567782|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567783|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567784|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567852|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
567785|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567786|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567787|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567788|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567789|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567790|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567791|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567792|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567793|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567794|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567795|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567796|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567797|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567798|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567799|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567800|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567853|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
569347|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
567801|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567802|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567803|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567804|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567805|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567806|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567807|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
567808|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567809|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
567810|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567811|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
567812|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567813|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
567814|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567815|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
567816|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567854|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
567817|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
567818|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567819|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
567820|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567821|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
567822|NCT00599339|E2|Reported Event|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
567823|NCT00599339|E1|Reported Event|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
567824|NCT00599326|B1|Baseline|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
567825|NCT00599326|P1|Participant Flow|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
567826|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
567827|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
567828|NCT00599326|E1|Reported Event|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
567829|NCT00599313|B1|Baseline|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567830|NCT00599313|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567831|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567832|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567833|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567834|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567835|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567836|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567837|NCT00599313|E1|Reported Event|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
567838|NCT00599248|B3|Baseline|Total|Total of all reporting groups
567839|NCT00599248|B2|Baseline|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
567840|NCT00599248|B1|Baseline|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
567841|NCT00599248|P4|Participant Flow|Placebo Control (DMEM)|"Placebo Control (DMEM)~Placebo: Placebo control (DMEM) administered by a single intraarticular injection"
567842|NCT00599248|P3|Participant Flow|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint administered by single intra-articular injection"
567843|NCT00599248|P2|Participant Flow|Active Treatment (TG-C) 2|"TissueGene-C at 1 x 10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint administered by single intra-articular injection"
567844|NCT00599248|P1|Participant Flow|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint administered by single intra-articular injection"
567845|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
567846|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
567847|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
567848|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
567849|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
569348|NCT00594425|O3|Outcome|Vehicle PDT|
567855|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
567856|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
567857|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
567858|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
567859|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
567860|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
567861|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
567862|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
567863|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x10e7 cells/joint to be administered by a single intra-articular injection"
567864|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
567865|NCT00599248|O4|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
567866|NCT00599248|O3|Outcome|Active Treatment (TG-C) 3|"TissueGene-C at 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e7 cells/joint to be administered by a single intra-articular injection"
567867|NCT00599248|O2|Outcome|Active Treatment (TG-C) 2|"TissueGene-C at 1x10e7 cells/joint~TissueGene-C: TissueGene-C at 1x107 cells/joint to be administered by a single intra-articular injection"
567868|NCT00599248|O1|Outcome|Active Treatment (TG-C) 1|"TissueGene-C at 3x10e6 cells/joint~TissueGene-C: TissueGene-C at 3x10e6 cells/joint to be administered by a single intra-articular injection"
567869|NCT00599248|E2|Reported Event|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
567870|NCT00599248|E1|Reported Event|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
567871|NCT00599196|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
567872|NCT00599196|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
567873|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
567874|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
567875|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
567876|NCT00599196|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
567877|NCT00599131|B1|Baseline|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
567878|NCT00599131|P1|Participant Flow|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
567879|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
567880|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
567881|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
567882|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
567883|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
569349|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
567884|NCT00599131|E1|Reported Event|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
567885|NCT00599053|B3|Baseline|Total|Total of all reporting groups
567886|NCT00599053|B2|Baseline|Expectant (Usual) Management|Intervention at the discretion of the attending physician
567887|NCT00599053|B1|Baseline|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
567888|NCT00599053|P2|Participant Flow|Expectant (Usual) Management|Intervention at the discretion of the attending physician
567889|NCT00599053|P1|Participant Flow|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
567890|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
567891|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
567892|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
567893|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
567894|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
567895|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
567896|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
567897|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
567898|NCT00599053|E2|Reported Event|Expectant (Usual) Management|Intervention at the discretion of the attending physician
567899|NCT00599053|E1|Reported Event|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
567900|NCT00599027|B3|Baseline|Total|Total of all reporting groups
567901|NCT00599027|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
567902|NCT00599027|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
567903|NCT00599027|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
567904|NCT00599027|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
567905|NCT00599027|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
567906|NCT00599027|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
567907|NCT00599027|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
567908|NCT00599027|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
567909|NCT00599014|B1|Baseline|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
567910|NCT00599014|P1|Participant Flow|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
567911|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
567912|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
567913|NCT00599014|E1|Reported Event|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
567914|NCT00598871|B3|Baseline|Total|Total of all reporting groups
567915|NCT00598871|B2|Baseline|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567916|NCT00598871|B1|Baseline|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567917|NCT00598871|P2|Participant Flow|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567918|NCT00598871|P1|Participant Flow|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567919|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567920|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567921|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567922|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567923|NCT00598871|E2|Reported Event|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567924|NCT00598871|E1|Reported Event|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
567925|NCT00598832|B3|Baseline|Total|Total of all reporting groups
567926|NCT00598832|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567927|NCT00598832|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
567928|NCT00598832|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567929|NCT00598832|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
567930|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567931|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567932|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567933|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567934|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567935|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567936|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567937|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567938|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567939|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
567940|NCT00598832|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
567941|NCT00598832|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
567942|NCT00598819|B1|Baseline|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567943|NCT00598819|P1|Participant Flow|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567944|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567945|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567946|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567947|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567948|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567949|NCT00598819|E1|Reported Event|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
567950|NCT00598806|B3|Baseline|Total|Total of all reporting groups
567951|NCT00598806|B2|Baseline|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567952|NCT00598806|B1|Baseline|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567953|NCT00598806|P2|Participant Flow|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567954|NCT00598806|P1|Participant Flow|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567955|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567956|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567957|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567958|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567959|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567960|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567961|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567962|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567963|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567964|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567965|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567966|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567967|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567968|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567969|NCT00598806|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567970|NCT00598806|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
567971|NCT00598806|E2|Reported Event|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
567972|NCT00598806|E1|Reported Event|Apaziquone|Apaziquone: TURBT + a single intravesical dose of EOquin® 4mg in 40ml instilled into the bladder post-TURBT
567973|NCT00598702|B9|Baseline|Total|Total of all reporting groups
567974|NCT00598702|B8|Baseline|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
567975|NCT00598702|B7|Baseline|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567976|NCT00598702|B6|Baseline|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567977|NCT00598702|B5|Baseline|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567978|NCT00598702|B4|Baseline|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567979|NCT00598702|B3|Baseline|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567980|NCT00598702|B2|Baseline|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567981|NCT00598702|B1|Baseline|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
567982|NCT00598702|P8|Participant Flow|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
567983|NCT00598702|P7|Participant Flow|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567984|NCT00598702|P6|Participant Flow|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567985|NCT00598702|P5|Participant Flow|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567986|NCT00598702|P4|Participant Flow|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567987|NCT00598702|P3|Participant Flow|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567988|NCT00598702|P2|Participant Flow|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567989|NCT00598702|P1|Participant Flow|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
567990|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
567991|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567992|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567993|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567994|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567995|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
567996|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
567997|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
567998|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
567999|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568033|NCT00598689|P2|Participant Flow|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
568000|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568001|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568002|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568003|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568004|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568005|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
568006|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
568007|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568008|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568009|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568010|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568011|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568012|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568013|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
568014|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
568015|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568016|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568017|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568018|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568019|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568020|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568021|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
568022|NCT00598702|E8|Reported Event|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
568023|NCT00598702|E7|Reported Event|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568024|NCT00598702|E6|Reported Event|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568025|NCT00598702|E5|Reported Event|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568026|NCT00598702|E4|Reported Event|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568027|NCT00598702|E3|Reported Event|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
568028|NCT00598702|E2|Reported Event|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
568029|NCT00598702|E1|Reported Event|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
568030|NCT00598689|B3|Baseline|Total|Total of all reporting groups
568031|NCT00598689|B2|Baseline|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
568032|NCT00598689|B1|Baseline|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
568034|NCT00598689|P1|Participant Flow|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
568035|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
568036|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
568037|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
568038|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
568039|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
568040|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
568041|NCT00598689|E2|Reported Event|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
568042|NCT00598689|E1|Reported Event|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
568043|NCT00598650|B1|Baseline|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
568044|NCT00598650|P1|Participant Flow|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
568045|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
568046|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
568047|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
568048|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
568049|NCT00598650|E1|Reported Event|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
568050|NCT00598585|B3|Baseline|Total|Total of all reporting groups
568051|NCT00598585|B2|Baseline|Placebo|Placebo: Placebo tid for 6 weeks
568052|NCT00598585|B1|Baseline|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
568053|NCT00598585|P2|Participant Flow|Placebo|Placebo: Placebo
568054|NCT00598585|P1|Participant Flow|Sildenafil|25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
568055|NCT00598585|O2|Outcome|Placebo|Placebo: Placebo
568056|NCT00598585|O1|Outcome|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
568057|NCT00598585|E2|Reported Event|Placebo|Placebo: Placebo
568058|NCT00598585|E1|Reported Event|Sildenafil|Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation.
568059|NCT00598559|B4|Baseline|Total|Total of all reporting groups
568060|NCT00598559|B3|Baseline|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
568061|NCT00598559|B2|Baseline|IV Acetaminophen 650 mg q4h|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
568062|NCT00598559|B1|Baseline|IV Acetaminophen 1g q6h|All Subjects Randomized to Receive IV acetaminophen 1g administered every 6 hours.
568063|NCT00598559|P3|Participant Flow|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
568064|NCT00598559|P2|Participant Flow|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
568065|NCT00598559|P1|Participant Flow|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
568066|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
568067|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
568068|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
568172|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568069|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
568070|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
568071|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
568072|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
568073|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
568074|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
568075|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
568076|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
568077|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
568078|NCT00598559|E3|Reported Event|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
568079|NCT00598559|E2|Reported Event|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
568080|NCT00598559|E1|Reported Event|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
568081|NCT00598507|B1|Baseline|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
568082|NCT00598507|P1|Participant Flow|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
568083|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
568084|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
568085|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
568086|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
568087|NCT00598507|E1|Reported Event|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
568088|NCT00598442|B4|Baseline|Total|Total of all reporting groups
568089|NCT00598442|B3|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568090|NCT00598442|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568091|NCT00598442|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568092|NCT00598442|P3|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568093|NCT00598442|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568094|NCT00598442|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568095|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568096|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568097|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568098|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568099|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568100|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568101|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568173|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568102|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568103|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568104|NCT00598442|E3|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568105|NCT00598442|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568106|NCT00598442|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568107|NCT00598273|B4|Baseline|Total|Total of all reporting groups
568108|NCT00598273|B3|Baseline|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568109|NCT00598273|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568110|NCT00598273|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568111|NCT00598273|P3|Participant Flow|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568112|NCT00598273|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568113|NCT00598273|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568114|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568115|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568116|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568117|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568118|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568119|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568120|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568121|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568122|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568123|NCT00598273|E3|Reported Event|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568124|NCT00598273|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
568125|NCT00598273|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
568126|NCT00598078|B1|Baseline|All Study Participants|All treated study participants
568127|NCT00598078|P2|Participant Flow|Regimen A, Then C, Then B|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2: Placebo at ~8am, ~10am, and ~12pm; Day 3: Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm;
568174|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
568128|NCT00598078|P1|Participant Flow|Regimen A, Then B, Then C|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2:Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; Day 3:Placebo at ~8am, ~10am, and ~12pm
568129|NCT00598078|O3|Outcome|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
568130|NCT00598078|O2|Outcome|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
568131|NCT00598078|O1|Outcome|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
568132|NCT00598078|E3|Reported Event|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
568133|NCT00598078|E2|Reported Event|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
568134|NCT00598078|E1|Reported Event|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
568135|NCT00597909|B4|Baseline|Total|Total of all reporting groups
568136|NCT00597909|B3|Baseline|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568137|NCT00597909|B2|Baseline|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568138|NCT00597909|B1|Baseline|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568139|NCT00597909|P3|Participant Flow|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568140|NCT00597909|P2|Participant Flow|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568141|NCT00597909|P1|Participant Flow|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568142|NCT00597909|O3|Outcome|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568143|NCT00597909|O2|Outcome|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568144|NCT00597909|O1|Outcome|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568145|NCT00597909|E3|Reported Event|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568146|NCT00597909|E2|Reported Event|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568147|NCT00597909|E1|Reported Event|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
568148|NCT00597896|B3|Baseline|Total|Total of all reporting groups
568149|NCT00597896|B2|Baseline|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568150|NCT00597896|B1|Baseline|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568151|NCT00597896|P2|Participant Flow|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568152|NCT00597896|P1|Participant Flow|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
568153|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568154|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568155|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568156|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568157|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568158|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568159|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568160|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568161|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568162|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568163|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568164|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568165|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568166|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568167|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568168|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568169|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568170|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
568171|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
568176|NCT00597896|E1|Reported Event|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
568177|NCT00597766|B4|Baseline|Total|Total of all reporting groups
568178|NCT00597766|B3|Baseline|60mg Triamcinolone|High dose group
568179|NCT00597766|B2|Baseline|40mg Triamcinolone|Standard dose group
568180|NCT00597766|B1|Baseline|20mg Triamcinolone|Low dose group.
568181|NCT00597766|P3|Participant Flow|60mg Triamcinolone|High dose group
568182|NCT00597766|P2|Participant Flow|40mg Triamcinolone|Standard dose group
568183|NCT00597766|P1|Participant Flow|20mg Triamcinolone|Low dose group.
568184|NCT00597766|O3|Outcome|60mg Triamcinolone|High dose group
568185|NCT00597766|O2|Outcome|40mg Triamcinolone|Standard dose group
568186|NCT00597766|O1|Outcome|20mg Triamcinolone|Low dose group.
568187|NCT00597766|O3|Outcome|60mg Triamcinolone|High dose group
568188|NCT00597766|O2|Outcome|40mg Triamcinolone|Standard dose group
568189|NCT00597766|O1|Outcome|20mg Triamcinolone|Low dose group.
568190|NCT00597766|O3|Outcome|60mg Triamcinolone|High dose group
568191|NCT00597766|O2|Outcome|40mg Triamcinolone|Standard dose group
568192|NCT00597766|O1|Outcome|20mg Triamcinolone|Low dose group.
568193|NCT00597766|O3|Outcome|60mg Triamcinolone|High dose group
568194|NCT00597766|O2|Outcome|40mg Triamcinolone|Standard dose group
568195|NCT00597766|O1|Outcome|20mg Triamcinolone|Low dose group.
568196|NCT00597766|E3|Reported Event|60mg Triamcinolone|High dose group
568197|NCT00597766|E2|Reported Event|40mg Triamcinolone|Standard dose group
568198|NCT00597766|E1|Reported Event|20mg Triamcinolone|Low dose group.
568199|NCT00597753|B3|Baseline|Total|Total of all reporting groups
568200|NCT00597753|B2|Baseline|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568201|NCT00597753|B1|Baseline|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568202|NCT00597753|P2|Participant Flow|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568203|NCT00597753|P1|Participant Flow|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568204|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568205|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568206|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568207|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568208|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568268|NCT00597675|E3|Reported Event|Blinded Phase-Peanut OIT|Patients receiving peanut flour as active OIT during the initial 12 months of therapy.
568269|NCT00597675|E2|Reported Event|Blinded Phase-Placebo|Patients receiving oat flour as a placebo during the initial 12 months of therapy.
568209|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568210|NCT00597753|E2|Reported Event|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568211|NCT00597753|E1|Reported Event|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
568212|NCT00597727|B5|Baseline|Total|Total of all reporting groups
568213|NCT00597727|B4|Baseline|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
568214|NCT00597727|B3|Baseline|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
568215|NCT00597727|B2|Baseline|Blinded Placebo SLIT|"Blinded subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.~Placebo SLIT: Liquid glycerin without peanut which are dosed under the tongue."
568216|NCT00597727|B1|Baseline|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops) at the beginning of the study.
568217|NCT00597727|P5|Participant Flow|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
568218|NCT00597727|P4|Participant Flow|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
568219|NCT00597727|P3|Participant Flow|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
568220|NCT00597727|P2|Participant Flow|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
568221|NCT00597727|P1|Participant Flow|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
568222|NCT00597727|O3|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
568223|NCT00597727|O2|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
568224|NCT00597727|O1|Outcome|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
568225|NCT00597727|O4|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
568226|NCT00597727|O3|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
568227|NCT00597727|O2|Outcome|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
568228|NCT00597727|O1|Outcome|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
568229|NCT00597727|E5|Reported Event|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
568230|NCT00597727|E4|Reported Event|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
568231|NCT00597727|E3|Reported Event|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
568232|NCT00597727|E2|Reported Event|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
568233|NCT00597727|E1|Reported Event|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
568234|NCT00597714|B3|Baseline|Total|Total of all reporting groups
568270|NCT00597675|E1|Reported Event|Open Label Phase-Peanut OIT|All subjects receiving open-label peanut OIT from the point of unblinding through the end of the treatment phase.
568271|NCT00597584|B3|Baseline|Total|Total of all reporting groups
568307|NCT00597506|E1|Reported Event|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
568372|NCT00597272|P7|Participant Flow|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
568235|NCT00597714|B2|Baseline|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568236|NCT00597714|B1|Baseline|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568237|NCT00597714|P3|Participant Flow|Donor|"5-6/6 matched sibling who meets the other donor criteria is the first choice,~Matched Unrelated Donor (MUD) is the second choice*, and~3-5/6 partially matched family member (if 5/6 then this donor is not a sibling as that would be first choice) is the third choice for donor type.~Multiple choices for 3-5/6 human leukocyte antigen (HLA) matched family member donors order of choice will be best match, then cytomegalovirus (CMV) negativity, then Killer-cell immunoglobulin-like receptors (KIR) mismatching (for natural killer [NK] cell activity), then history of pregnancy. All subjects without an available matched sibling must have a donor search initiated with the national bank. If potential high resolution matches are found but not utilized, the reason for proceeding with a partially matched family member should be documented (i.e. donor not available, not enough time to allow MUD donor work up and collection due to high risk nature of the subject's disease, etc)."
568238|NCT00597714|P2|Participant Flow|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568239|NCT00597714|P1|Participant Flow|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568240|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568241|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568242|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568304|NCT00597506|P1|Participant Flow|Drug: Bevacizumab and Everolimus|Open-label, non-randomized expanded cohort trial of refractory metastatic colorectal cancer subjects treated on 28 day cycles with the following treatment regimen: 10 mg/kg intravenous bevacizumab on days 1 and 15 each cycle and 10 mg everolimus(RAD001) daily by mouth.
568243|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. For the myeloid group, the prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568244|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568245|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568246|NCT00597714|E2|Reported Event|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568247|NCT00597714|E1|Reported Event|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
568248|NCT00597701|B3|Baseline|Total|Total of all reporting groups
568249|NCT00597701|B2|Baseline|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
568250|NCT00597701|B1|Baseline|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
568251|NCT00597701|P2|Participant Flow|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
568252|NCT00597701|P1|Participant Flow|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
568253|NCT00597701|O2|Outcome|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
568254|NCT00597701|O1|Outcome|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
568255|NCT00597701|E2|Reported Event|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
568256|NCT00597701|E1|Reported Event|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
568257|NCT00597675|B3|Baseline|Total|Total of all reporting groups
568258|NCT00597675|B2|Baseline|Peanut OIT|Peanut flour ingested daily as active OIT treatment
568259|NCT00597675|B1|Baseline|Placebo|Oat flour taken daily as a placebo
568260|NCT00597675|P2|Participant Flow|Peanut OIT|Peanut flour ingested daily as active OIT treatment
568261|NCT00597675|P1|Participant Flow|Placebo|Oat flour taken daily as a placebo
568262|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
568263|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
568264|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
568265|NCT00597675|O2|Outcome|Peanut OIT|Peanut flour ingested daily as active OIT treatment
568266|NCT00597675|O1|Outcome|Placebo|Oat flour taken daily as a placebo
568267|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
568272|NCT00597584|B2|Baseline|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568273|NCT00597584|B1|Baseline|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568274|NCT00597584|P2|Participant Flow|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568275|NCT00597584|P1|Participant Flow|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568276|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568277|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568278|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568279|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568280|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568281|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568305|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
568306|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
568282|NCT00597584|E2|Reported Event|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568283|NCT00597584|E1|Reported Event|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
568284|NCT00597558|B1|Baseline|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
568285|NCT00597558|P1|Participant Flow|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
568286|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
568287|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
568288|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
568289|NCT00597558|E1|Reported Event|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
568290|NCT00597545|B3|Baseline|Total|Total of all reporting groups
568291|NCT00597545|B2|Baseline|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568292|NCT00597545|B1|Baseline|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568293|NCT00597545|P2|Participant Flow|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568294|NCT00597545|P1|Participant Flow|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568295|NCT00597545|O2|Outcome|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568296|NCT00597545|O1|Outcome|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568297|NCT00597545|E2|Reported Event|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568298|NCT00597545|E1|Reported Event|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
568299|NCT00597519|B1|Baseline|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
568300|NCT00597519|P1|Participant Flow|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
568301|NCT00597519|O1|Outcome|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
568302|NCT00597519|E1|Reported Event|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
568303|NCT00597506|B1|Baseline|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
569350|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
568308|NCT00597493|B1|Baseline|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
568309|NCT00597493|P1|Participant Flow|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
568310|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
568311|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
568312|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
568313|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
568314|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
568315|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
568316|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
568317|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
568318|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
568319|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
568320|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
568321|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
568322|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
568323|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
568324|NCT00597493|E1|Reported Event|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
568325|NCT00597428|B3|Baseline|Total|Total of all reporting groups
568326|NCT00597428|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568327|NCT00597428|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568328|NCT00597428|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for 12 weeks
568329|NCT00597428|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for 12 weeks
568330|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568331|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568332|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568333|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568334|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568335|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568336|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568337|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568338|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568339|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568340|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568341|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568342|NCT00597428|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568343|NCT00597428|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568344|NCT00597402|B1|Baseline|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
568373|NCT00597272|P6|Participant Flow|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568345|NCT00597402|P1|Participant Flow|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
568346|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
568347|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
568348|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
568349|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
568350|NCT00597402|E1|Reported Event|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
568351|NCT00597376|B3|Baseline|Total|Total of all reporting groups
568352|NCT00597376|B2|Baseline|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
568353|NCT00597376|B1|Baseline|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
568354|NCT00597376|P2|Participant Flow|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
568355|NCT00597376|P1|Participant Flow|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
568356|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
568357|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
568358|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
568359|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
568360|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
568361|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
568362|NCT00597376|E2|Reported Event|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
568363|NCT00597376|E1|Reported Event|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
568364|NCT00597272|B8|Baseline|Total|Total of all reporting groups
568365|NCT00597272|B7|Baseline|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
568366|NCT00597272|B6|Baseline|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568367|NCT00597272|B5|Baseline|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568368|NCT00597272|B4|Baseline|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
568369|NCT00597272|B3|Baseline|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568370|NCT00597272|B2|Baseline|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568371|NCT00597272|B1|Baseline|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
569351|NCT00594425|O3|Outcome|Vehicle PDT|
568374|NCT00597272|P5|Participant Flow|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568375|NCT00597272|P4|Participant Flow|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
568376|NCT00597272|P3|Participant Flow|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568377|NCT00597272|P2|Participant Flow|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568378|NCT00597272|P1|Participant Flow|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568379|NCT00597272|O7|Outcome|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
568380|NCT00597272|O6|Outcome|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568381|NCT00597272|O5|Outcome|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568382|NCT00597272|O4|Outcome|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
568383|NCT00597272|O3|Outcome|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568384|NCT00597272|O2|Outcome|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568385|NCT00597272|O1|Outcome|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568386|NCT00597272|E7|Reported Event|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
568387|NCT00597272|E6|Reported Event|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568388|NCT00597272|E5|Reported Event|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
568389|NCT00597272|E4|Reported Event|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
568390|NCT00597272|E3|Reported Event|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568391|NCT00597272|E2|Reported Event|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568392|NCT00597272|E1|Reported Event|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
568393|NCT00597207|B3|Baseline|Total|Total of all reporting groups
568394|NCT00597207|B2|Baseline|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
568395|NCT00597207|B1|Baseline|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
568396|NCT00597207|P2|Participant Flow|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
568397|NCT00597207|P1|Participant Flow|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
568398|NCT00597207|O2|Outcome|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
568399|NCT00597207|O1|Outcome|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
568400|NCT00597207|E2|Reported Event|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
568401|NCT00597207|E1|Reported Event|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
568402|NCT00597116|B3|Baseline|Total|Total of all reporting groups
568403|NCT00597116|B2|Baseline|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
568404|NCT00597116|B1|Baseline|Vandetanib|Vandetanib 300 mg/day oral
568405|NCT00597116|P2|Participant Flow|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
568406|NCT00597116|P1|Participant Flow|Vandetanib|Vandetanib 300 mg/day oral
568407|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
568408|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
568409|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
568410|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
568411|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
568412|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
568413|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
568414|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
568415|NCT00597116|E2|Reported Event|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
568416|NCT00597116|E1|Reported Event|Vandetanib|Vandetanib 300 mg/day oral
568417|NCT00597038|B3|Baseline|Total|Total of all reporting groups
568418|NCT00597038|B2|Baseline|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
568419|NCT00597038|B1|Baseline|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
568420|NCT00597038|P2|Participant Flow|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
568421|NCT00597038|P1|Participant Flow|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
568422|NCT00597038|O2|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
568423|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
568424|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
568425|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
568426|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC)
568427|NCT00597038|E2|Reported Event|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
568428|NCT00597038|E1|Reported Event|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
568429|NCT00597012|B3|Baseline|Total|Total of all reporting groups
568430|NCT00597012|B2|Baseline|Physical Therapy|Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
568431|NCT00597012|B1|Baseline|Arthroscopic Partial Meniscectomy|Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
568432|NCT00597012|P2|Participant Flow|Physical Therapy (PT)|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
568433|NCT00597012|P1|Participant Flow|Arthroscopic Partial Meniscectomy (APM)|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
568434|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
568435|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
568436|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
568437|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
568438|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
568439|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
568440|NCT00597012|E2|Reported Event|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
568441|NCT00597012|E1|Reported Event|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
568442|NCT00596960|B3|Baseline|Total|Total of all reporting groups
568443|NCT00596960|B2|Baseline|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
568444|NCT00596960|B1|Baseline|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
568445|NCT00596960|P2|Participant Flow|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
568446|NCT00596960|P1|Participant Flow|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
568447|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
568448|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
568449|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
568450|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
568451|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
568452|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
568453|NCT00596960|E2|Reported Event|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
568454|NCT00596960|E1|Reported Event|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
568455|NCT00596947|B3|Baseline|Total|Total of all reporting groups
568456|NCT00596947|B2|Baseline|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568457|NCT00596947|B1|Baseline|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568458|NCT00596947|P2|Participant Flow|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568459|NCT00596947|P1|Participant Flow|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568460|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568461|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568462|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568463|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568464|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568465|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568466|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568467|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568468|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568469|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568500|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568501|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568470|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568471|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568472|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568473|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568474|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568475|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568476|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568477|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568478|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568479|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568480|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568481|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568482|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568483|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568502|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568503|NCT00596934|O1|Outcome|Metreleptin Treatment Group|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
569352|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
568484|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568485|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568486|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568487|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568488|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568489|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568490|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568491|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568492|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568493|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568494|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568495|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568496|NCT00596947|E2|Reported Event|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
568497|NCT00596947|E1|Reported Event|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
568498|NCT00596934|B1|Baseline|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568499|NCT00596934|P1|Participant Flow|NASH02|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
569353|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
568504|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568505|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568506|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
568507|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568508|NCT00596934|E1|Reported Event|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
568509|NCT00596830|B3|Baseline|Total|Total of all reporting groups
568510|NCT00596830|B2|Baseline|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568511|NCT00596830|B1|Baseline|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568512|NCT00596830|P2|Participant Flow|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568513|NCT00596830|P1|Participant Flow|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568514|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568515|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568516|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568517|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568518|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568519|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568520|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568521|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568522|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568523|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568559|NCT00596817|E3|Reported Event|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|
568560|NCT00596817|E2|Reported Event|Placebo - Double-blind Period (FAS)|
568561|NCT00596817|E1|Reported Event|Open-label Period (APTS)|
569354|NCT00594425|O3|Outcome|Vehicle PDT|
568524|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568525|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568526|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568527|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568528|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568529|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568530|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568531|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568532|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568533|NCT00596830|E2|Reported Event|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
568534|NCT00596830|E1|Reported Event|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
568535|NCT00596817|B4|Baseline|Total|Total of all reporting groups
568536|NCT00596817|B3|Baseline|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
568537|NCT00596817|B2|Baseline|Placebo - Double-blind Period (FAS)|Placebo : capsules, daily, orally
568538|NCT00596817|B1|Baseline|Open-label Period (APTS)|
568539|NCT00596817|P2|Participant Flow|Vortioxetine: 5 or 10 mg|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
568540|NCT00596817|P1|Participant Flow|Placebo|Placebo : capsules, daily, orally
568541|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568542|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568543|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568544|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568545|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568546|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568547|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568548|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568549|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568550|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568551|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568552|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568553|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568554|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568555|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568556|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568557|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
568558|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
568563|NCT00596752|B2|Baseline|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568564|NCT00596752|B1|Baseline|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568565|NCT00596752|P2|Participant Flow|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568566|NCT00596752|P1|Participant Flow|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568567|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568568|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568569|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568570|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568571|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568572|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568573|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568574|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568575|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568576|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568577|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568578|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568579|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568580|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568581|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568582|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568583|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568584|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568585|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568586|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568587|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568588|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568589|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568590|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568591|NCT00596752|E2|Reported Event|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568592|NCT00596752|E1|Reported Event|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
568593|NCT00596687|B3|Baseline|Total|Total of all reporting groups
568594|NCT00596687|B2|Baseline|SSRI|Sliding scale regular insulin four-times daily.
568595|NCT00596687|B1|Baseline|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
568596|NCT00596687|P2|Participant Flow|SSRI|Sliding scale regular insulin four-times daily if blood glucose > 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol.
568597|NCT00596687|P1|Participant Flow|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals.
568598|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
568599|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
568600|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
568601|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
568602|NCT00596687|E2|Reported Event|SSRI|Sliding scale regular insulin four-times daily.
568603|NCT00596687|E1|Reported Event|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
568604|NCT00596635|B4|Baseline|Total|Total of all reporting groups
568605|NCT00596635|B3|Baseline|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
568606|NCT00596635|B2|Baseline|One Cranberry Capsule|1 650mg cranberry capsule daily
568607|NCT00596635|B1|Baseline|No Cranberry Capsules|Control Group No Cranberry Capsule
568608|NCT00596635|P3|Participant Flow|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
568609|NCT00596635|P2|Participant Flow|One Cranberry Capsule|1 650mg cranberry capsule daily
568610|NCT00596635|P1|Participant Flow|No Cranberry Capsules|Control Group No Cranberry Capsule
568611|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
568612|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
568613|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
568614|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
568615|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
568616|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
568617|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
568618|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
568619|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
568620|NCT00596635|E3|Reported Event|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
568621|NCT00596635|E2|Reported Event|One Cranberry Capsule|1 650mg cranberry capsule daily
568622|NCT00596635|E1|Reported Event|No Cranberry Capsules|Control Group No Cranberry Capsule
568623|NCT00596622|B4|Baseline|Total|Total of all reporting groups
568624|NCT00596622|B3|Baseline|Bipolar Euthymic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
568717|NCT00596102|B3|Baseline|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
568625|NCT00596622|B2|Baseline|Bipolar Manic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
568626|NCT00596622|B1|Baseline|Bipolar Depressed Subjects Treated With Lithium|"Participants with bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
568627|NCT00596622|P1|Participant Flow|Bipolar Subjects Who Were Included in Lithium Treatment Arm|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
568628|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Bipolar euthymia picture response before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
568629|NCT00596622|O2|Outcome|Bipolar Depressed Subjects Treated|"Bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
568630|NCT00596622|O1|Outcome|Bipolar Manic Subjects Treated|"Bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
568631|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Participants with bipolar euthymia who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
568632|NCT00596622|O2|Outcome|Bipolar Manic Subjects Treated|"Participants with bipolar mania who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
568633|NCT00596622|O1|Outcome|Bipolar Depressed Participants Treated|"Participants with bipolar depression who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
568634|NCT00596622|E1|Reported Event|Bipolar Participants Treated|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks.~Adverse Events information was collected irrespective of the sub-grouping"
568635|NCT00596466|B1|Baseline|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
568636|NCT00596466|P1|Participant Flow|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
568637|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
568638|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
568639|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
568640|NCT00596466|E1|Reported Event|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
568641|NCT00596453|B3|Baseline|Total|Total of all reporting groups
568642|NCT00596453|B2|Baseline|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
568643|NCT00596453|B1|Baseline|Placebo|Placebo: Placebo twice a day for 14 days
568644|NCT00596453|P2|Participant Flow|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
568645|NCT00596453|P1|Participant Flow|Placebo|Placebo: Placebo twice a day for 14 days
568646|NCT00596453|O2|Outcome|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
568647|NCT00596453|O1|Outcome|Placebo|Placebo: Placebo twice a day for 14 days
568648|NCT00596453|E2|Reported Event|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
568649|NCT00596453|E1|Reported Event|Placebo|Placebo: Placebo twice a day for 14 days
568650|NCT00596440|B3|Baseline|Total|Total of all reporting groups
568651|NCT00596440|B2|Baseline|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
568652|NCT00596440|B1|Baseline|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
569355|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
568653|NCT00596440|P2|Participant Flow|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
568654|NCT00596440|P1|Participant Flow|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
568655|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
568656|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
568657|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
568658|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
568659|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
568660|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
568661|NCT00596440|E2|Reported Event|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
568662|NCT00596440|E1|Reported Event|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
568663|NCT00596427|B3|Baseline|Total|Total of all reporting groups
568664|NCT00596427|B2|Baseline|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568665|NCT00596427|B1|Baseline|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568666|NCT00596427|P2|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568667|NCT00596427|P1|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568668|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568669|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568670|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568671|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568672|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568673|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568674|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568675|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568676|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568677|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568678|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568679|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568680|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568681|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568682|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568683|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568684|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568718|NCT00596102|B2|Baseline|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
568685|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568686|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568687|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75grams/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568688|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568689|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568690|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
568691|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568692|NCT00596427|E2|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568693|NCT00596427|E1|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
568694|NCT00596362|B1|Baseline|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
568695|NCT00596362|P1|Participant Flow|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
568696|NCT00596362|O1|Outcome|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
568697|NCT00596362|E1|Reported Event|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
568698|NCT00596271|B4|Baseline|Total|Total of all reporting groups
568699|NCT00596271|B3|Baseline|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
568700|NCT00596271|B2|Baseline|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
568701|NCT00596271|B1|Baseline|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
568702|NCT00596271|P3|Participant Flow|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
568703|NCT00596271|P2|Participant Flow|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
568704|NCT00596271|P1|Participant Flow|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
568705|NCT00596271|O2|Outcome|IC51 + HAVRIX|
568706|NCT00596271|O1|Outcome|HAVRIX + Placebo|
568707|NCT00596271|O2|Outcome|IC51 and HAVRIX|
568708|NCT00596271|O1|Outcome|IC51 and Placebo|
568709|NCT00596271|E3|Reported Event|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
568710|NCT00596271|E2|Reported Event|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
568711|NCT00596271|E1|Reported Event|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
568712|NCT00596167|B1|Baseline|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
568713|NCT00596167|P1|Participant Flow|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
568714|NCT00596167|O1|Outcome|Intravenous Antibiotic (Vancomycin)|This study will have only one arm. All six participants in the study will receive an intravenous dose of the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
568715|NCT00596167|E1|Reported Event|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
568716|NCT00596102|B4|Baseline|Total|Total of all reporting groups
568719|NCT00596102|B1|Baseline|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
568720|NCT00596102|P3|Participant Flow|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
568721|NCT00596102|P2|Participant Flow|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
568722|NCT00596102|P1|Participant Flow|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
568723|NCT00596102|O1|Outcome|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
568724|NCT00596102|E4|Reported Event|IC51 Month 60|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60
568725|NCT00596102|E3|Reported Event|Placebo|no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
568726|NCT00596102|E2|Reported Event|JE-VAX|no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
568727|NCT00596102|E1|Reported Event|IC51 Month 6|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
568728|NCT00596011|B3|Baseline|Total|Total of all reporting groups
568729|NCT00596011|B2|Baseline|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568730|NCT00596011|B1|Baseline|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568731|NCT00596011|P2|Participant Flow|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568732|NCT00596011|P1|Participant Flow|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568733|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568734|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568735|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568736|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568737|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568738|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568739|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568740|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568741|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568742|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568743|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568744|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568745|NCT00596011|E2|Reported Event|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
568746|NCT00596011|E1|Reported Event|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
568747|NCT00595959|B1|Baseline|Laser Treatment|CLiRpath Photoablation Atherectomy System
568748|NCT00595959|P1|Participant Flow|Laser Treatment|CLiRpath Photoablation Atherectomy System
568749|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568750|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568751|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568752|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568753|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568754|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568755|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568756|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568757|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568758|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568759|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568760|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
568761|NCT00595959|E1|Reported Event|Laser Treatment|CLiRpath Photoablation Atherectomy System
568762|NCT00595946|B3|Baseline|Total|Total of all reporting groups
568763|NCT00595946|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568764|NCT00595946|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568765|NCT00595946|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for up to 12 weeks
568766|NCT00595946|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for up to 12 weeks
568767|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568768|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568769|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568770|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568771|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568772|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568773|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568774|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568775|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568776|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568777|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568778|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568779|NCT00595946|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
568780|NCT00595946|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
568781|NCT00595920|B1|Baseline|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
568782|NCT00595920|P1|Participant Flow|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
568783|NCT00595920|O1|Outcome|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
568784|NCT00595920|E1|Reported Event|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
568785|NCT00595881|B1|Baseline|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
568786|NCT00595881|P1|Participant Flow|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
568787|NCT00595881|O2|Outcome|Clinical Exam+ Ultrasound|Patients will have data collected following the addition of a bedside ultrasound performed to the clinical exam.
568788|NCT00595881|O1|Outcome|Clinical Exam Alone|Patients will have data collected from their clinical examination alone
568789|NCT00595881|E1|Reported Event|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
568790|NCT00595868|B3|Baseline|Total|Total of all reporting groups
568791|NCT00595868|B2|Baseline|Placebo|Placebo once per day for 2-8 weeks
568792|NCT00595868|B1|Baseline|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
568793|NCT00595868|P2|Participant Flow|Placebo|Placebo once per day for 2-8 weeks
568794|NCT00595868|P1|Participant Flow|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
568795|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
568796|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
568797|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
568798|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
568799|NCT00595868|E2|Reported Event|Placebo|Placebo once per day for 2-8 weeks
568800|NCT00595868|E1|Reported Event|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
568801|NCT00595790|B4|Baseline|Total|Total of all reporting groups
568802|NCT00595790|B3|Baseline|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
568803|NCT00595790|B2|Baseline|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
568804|NCT00595790|B1|Baseline|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
568805|NCT00595790|P3|Participant Flow|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
568806|NCT00595790|P2|Participant Flow|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
568807|NCT00595790|P1|Participant Flow|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
568808|NCT00595790|O3|Outcome|IC51 1x6 mcg|
568809|NCT00595790|O2|Outcome|IC51 2x6 mcg|
568810|NCT00595790|O1|Outcome|IC51 1 x 12 mcg|
568811|NCT00595790|E3|Reported Event|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
568812|NCT00595790|E2|Reported Event|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
568813|NCT00595790|E1|Reported Event|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
568814|NCT00595764|B3|Baseline|Total|Total of all reporting groups
568815|NCT00595764|B2|Baseline|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568816|NCT00595764|B1|Baseline|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568817|NCT00595764|P2|Participant Flow|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568846|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568881|NCT00595478|O2|Outcome|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
568818|NCT00595764|P1|Participant Flow|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568819|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568820|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568821|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568822|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568823|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568824|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568825|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568826|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568847|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
568848|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568882|NCT00595478|O1|Outcome|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
568827|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568828|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568829|NCT00595764|E2|Reported Event|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
568830|NCT00595764|E1|Reported Event|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
568831|NCT00595582|B1|Baseline|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
568832|NCT00595582|P1|Participant Flow|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
568833|NCT00595582|O1|Outcome|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
568834|NCT00595582|E1|Reported Event|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
568835|NCT00595556|B3|Baseline|Total|Total of all reporting groups
568836|NCT00595556|B2|Baseline|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568837|NCT00595556|B1|Baseline|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
568838|NCT00595556|P2|Participant Flow|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568839|NCT00595556|P1|Participant Flow|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
568840|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568841|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
568842|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568843|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
568844|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568845|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
569356|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569357|NCT00594425|O3|Outcome|Vehicle PDT|
568849|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
568850|NCT00595556|E2|Reported Event|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
568851|NCT00595556|E1|Reported Event|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
568852|NCT00595530|B1|Baseline|Protocol for Administering Ketamine to Patients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
568853|NCT00595530|P1|Participant Flow|Procedure for Administering Ketamine to SCDpatients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
568854|NCT00595530|O1|Outcome|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
568855|NCT00595530|E1|Reported Event|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
568856|NCT00595517|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
568857|NCT00595517|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
568858|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
568859|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
568860|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
568861|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
568862|NCT00595517|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
568863|NCT00595504|B3|Baseline|Total|Total of all reporting groups
568864|NCT00595504|B2|Baseline|Placebo|sugar pill
568865|NCT00595504|B1|Baseline|Ramelteon|
568866|NCT00595504|P2|Participant Flow|Placebo|sugar pill
568867|NCT00595504|P1|Participant Flow|Ramelteon|
568868|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
568869|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
568870|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
568871|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
568872|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
568873|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
568874|NCT00595504|E2|Reported Event|Placebo|sugar pill
568875|NCT00595504|E1|Reported Event|Ramelteon|
568876|NCT00595478|B3|Baseline|Total|Total of all reporting groups
568877|NCT00595478|B2|Baseline|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
568878|NCT00595478|B1|Baseline|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
568879|NCT00595478|P2|Participant Flow|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
568880|NCT00595478|P1|Participant Flow|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
568883|NCT00595478|O2|Outcome|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
568884|NCT00595478|O1|Outcome|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
568885|NCT00595478|E2|Reported Event|(MET)/CBT|"Motivational Enhancement Therapy (MET)/CBT~Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment"
568886|NCT00595478|E1|Reported Event|(MET)/CBT+CM/BPT|"Motivational Enhancement Therapy (MET)/CBT+CM/BPT~Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment"
568887|NCT00595465|B4|Baseline|Total|Total of all reporting groups
568888|NCT00595465|B3|Baseline|IC51 Batch IC51/07E/008A|
568889|NCT00595465|B2|Baseline|IC51 Batch IC51/07E/007A|
568890|NCT00595465|B1|Baseline|IC51 Batch IC51/07E/006A|
568891|NCT00595465|P3|Participant Flow|IC51 Batch IC51/07E/008A|
568892|NCT00595465|P2|Participant Flow|IC51 Batch IC51/07E/007A|
568893|NCT00595465|P1|Participant Flow|IC51 Batch IC51/07E/006A|
568894|NCT00595465|O3|Outcome|IC51 Batch IC51/07E/008A|
568895|NCT00595465|O2|Outcome|IC51 Batch IC51/07E/007A|
568896|NCT00595465|O1|Outcome|IC51 Batch IC51/07E/006A|
568897|NCT00595465|E3|Reported Event|IC51 Batch IC51/07E/008A|
568898|NCT00595465|E2|Reported Event|IC51 Batch IC51/07E/007A|
568899|NCT00595465|E1|Reported Event|IC51 Batch IC51/07E/006A|
568900|NCT00595413|B5|Baseline|Total|Total of all reporting groups
568901|NCT00595413|B4|Baseline|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568902|NCT00595413|B3|Baseline|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568903|NCT00595413|B2|Baseline|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
568904|NCT00595413|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568905|NCT00595413|P4|Participant Flow|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568906|NCT00595413|P3|Participant Flow|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568907|NCT00595413|P2|Participant Flow|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
568908|NCT00595413|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568909|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568910|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568911|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
568912|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568913|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568914|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568915|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
568916|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568917|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568918|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568919|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
568920|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568921|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568922|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568923|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
569358|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
568924|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568925|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568926|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568927|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
568928|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568929|NCT00595413|E4|Reported Event|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
568930|NCT00595413|E3|Reported Event|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
568931|NCT00595413|E2|Reported Event|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
568932|NCT00595413|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
568933|NCT00595361|B3|Baseline|Total|Total of all reporting groups
568934|NCT00595361|B2|Baseline|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568935|NCT00595361|B1|Baseline|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568936|NCT00595361|P2|Participant Flow|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568937|NCT00595361|P1|Participant Flow|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568938|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568939|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568940|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568941|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568942|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568943|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568944|NCT00595361|E2|Reported Event|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568945|NCT00595361|E1|Reported Event|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
568946|NCT00595335|B3|Baseline|Total|Total of all reporting groups
568947|NCT00595335|B2|Baseline|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568948|NCT00595335|B1|Baseline|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568949|NCT00595335|P2|Participant Flow|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568950|NCT00595335|P1|Participant Flow|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568951|NCT00595335|O2|Outcome|Placebo|Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
568952|NCT00595335|O1|Outcome|Rituximab|Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
568953|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568954|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
569020|NCT00595075|B2|Baseline|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
569359|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
568955|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568956|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568957|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568958|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568959|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568960|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568961|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568962|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568963|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568964|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568965|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568966|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568967|NCT00595335|E2|Reported Event|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
568968|NCT00595335|E1|Reported Event|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
568969|NCT00595309|B1|Baseline|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
568970|NCT00595309|P1|Participant Flow|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
568971|NCT00595309|O1|Outcome|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
568972|NCT00595309|E1|Reported Event|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
568973|NCT00595270|B4|Baseline|Total|Total of all reporting groups
568974|NCT00595270|B3|Baseline|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
568975|NCT00595270|B2|Baseline|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
568976|NCT00595270|B1|Baseline|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
568977|NCT00595270|P3|Participant Flow|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
568978|NCT00595270|P2|Participant Flow|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
568979|NCT00595270|P1|Participant Flow|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
568980|NCT00595270|O3|Outcome|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
568981|NCT00595270|O2|Outcome|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
568982|NCT00595270|O1|Outcome|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
568983|NCT00595270|E3|Reported Event|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
568984|NCT00595270|E2|Reported Event|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
568985|NCT00595270|E1|Reported Event|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
568986|NCT00595153|B4|Baseline|Total|Total of all reporting groups
568987|NCT00595153|B3|Baseline|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568988|NCT00595153|B2|Baseline|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568989|NCT00595153|B1|Baseline|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
568990|NCT00595153|P3|Participant Flow|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568991|NCT00595153|P2|Participant Flow|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568992|NCT00595153|P1|Participant Flow|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
568993|NCT00595153|O3|Outcome|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568994|NCT00595153|O2|Outcome|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568995|NCT00595153|O1|Outcome|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
568996|NCT00595153|E3|Reported Event|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568997|NCT00595153|E2|Reported Event|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
568998|NCT00595153|E1|Reported Event|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
568999|NCT00595127|B1|Baseline|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
569000|NCT00595127|P1|Participant Flow|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
569001|NCT00595127|O1|Outcome|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
569002|NCT00595127|E1|Reported Event|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
569003|NCT00595114|B3|Baseline|Total|Total of all reporting groups
569004|NCT00595114|B2|Baseline|KIA 1|Participants from the KIA trial with severe asthma
569005|NCT00595114|B1|Baseline|MIA 1|Participants from the MIA trial with mild asthma
569006|NCT00595114|P2|Participant Flow|KIA 1|Participants from the KIA trial with severe asthma
569007|NCT00595114|P1|Participant Flow|MIA 1|Participants from the MIA trial with mild asthma
569008|NCT00595114|O2|Outcome|KIA 1|Participants from the KIA trial with severe asthma
569009|NCT00595114|O1|Outcome|MIA 1|Participants from the MIA trial with mild asthma
569010|NCT00595114|E2|Reported Event|KIA 1|Participants from the KIA trial with severe asthma
569011|NCT00595114|E1|Reported Event|MIA 1|Participants from the MIA trial with mild asthma
569012|NCT00595088|B1|Baseline|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
569013|NCT00595088|P1|Participant Flow|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
569014|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
569015|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
569016|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
569017|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
569018|NCT00595088|E1|Reported Event|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
569019|NCT00595075|B3|Baseline|Total|Total of all reporting groups
569331|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569021|NCT00595075|B1|Baseline|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
569022|NCT00595075|P2|Participant Flow|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
569023|NCT00595075|P1|Participant Flow|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
569024|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
569025|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569026|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
569027|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569028|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
569029|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569030|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
569031|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569032|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
569033|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569034|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
569035|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569036|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
569037|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569038|NCT00595075|E2|Reported Event|Placebo|Placebo will be given prior to a 2-hour nap
569039|NCT00595075|E1|Reported Event|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
569040|NCT00594958|B4|Baseline|Total|Total of all reporting groups
569041|NCT00594958|B3|Baseline|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569042|NCT00594958|B2|Baseline|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569043|NCT00594958|B1|Baseline|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569044|NCT00594958|P3|Participant Flow|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569045|NCT00594958|P2|Participant Flow|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569046|NCT00594958|P1|Participant Flow|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569047|NCT00594958|O3|Outcome|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569048|NCT00594958|O2|Outcome|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569049|NCT00594958|O1|Outcome|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569050|NCT00594958|E3|Reported Event|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569051|NCT00594958|E2|Reported Event|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569052|NCT00594958|E1|Reported Event|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
569053|NCT00594945|B4|Baseline|Total|Total of all reporting groups
569054|NCT00594945|B3|Baseline|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|
569055|NCT00594945|B2|Baseline|Intranasal Clonazepam 3 mg|
569056|NCT00594945|B1|Baseline|Intranasal Clonazepam 2 mg|
569057|NCT00594945|P3|Participant Flow|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2
569058|NCT00594945|P2|Participant Flow|Intranasal Clonazepam 3 mg|Treatment administered to subjects during Cohort 2
569059|NCT00594945|P1|Participant Flow|Intranasal Clonazepam 2 mg|Treatment administered to subjects during Cohort 1
569060|NCT00594945|O2|Outcome|Intranasal Clonazepam 3 mg|
569061|NCT00594945|O1|Outcome|Intranasal Clonazepam 2 mg|
569062|NCT00594945|E2|Reported Event|Intranasal Clonazepam 3 mg|
569063|NCT00594945|E1|Reported Event|Intranasal Clonazepam 2 mg|
569064|NCT00594906|B3|Baseline|Total|Total of all reporting groups
569065|NCT00594906|B2|Baseline|Placebo|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
569066|NCT00594906|B1|Baseline|Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
569067|NCT00594906|P2|Participant Flow|Placebo Injection|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
569068|NCT00594906|P1|Participant Flow|Forteo Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
569069|NCT00594906|O2|Outcome|Forteo Patients|Patients who recieved Forteo Injections.
569070|NCT00594906|O1|Outcome|Placebo Patients|Patients who recieved Placebo injections.
569071|NCT00594906|E2|Reported Event|Placebo Injection|Patients who were randomized to Placebo
569072|NCT00594906|E1|Reported Event|Forteo Injection|Patients who randomized to the study drug, Forteo
569073|NCT00594880|B3|Baseline|Total|Total of all reporting groups
569074|NCT00594880|B2|Baseline|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569332|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569333|NCT00594425|O3|Outcome|Vehicle PDT|
569075|NCT00594880|B1|Baseline|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569076|NCT00594880|P2|Participant Flow|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569077|NCT00594880|P1|Participant Flow|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569078|NCT00594880|O2|Outcome|90 mcg/Week|Arm 2 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
569079|NCT00594880|O1|Outcome|180 mcg/Week|Arm 1 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
569080|NCT00594880|O2|Outcome|90 mcg/Week|Patients receiving 90 micrograms/week of pegylated interferon alpha-2a
569081|NCT00594880|O1|Outcome|180 mcg/Week|Patients receiving 180 micrograms/week of pegylated interferon alpha-2a
569082|NCT00594880|O2|Outcome|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569083|NCT00594880|O1|Outcome|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569084|NCT00594880|E2|Reported Event|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569085|NCT00594880|E1|Reported Event|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
569086|NCT00594854|B3|Baseline|Total|Total of all reporting groups
569087|NCT00594854|B2|Baseline|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
569088|NCT00594854|B1|Baseline|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
569089|NCT00594854|P2|Participant Flow|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
569090|NCT00594854|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
569091|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
569092|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
569093|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
569094|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
569095|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
569096|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
569097|NCT00594854|E2|Reported Event|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
569098|NCT00594854|E1|Reported Event|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
569099|NCT00594815|B1|Baseline|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
569100|NCT00594815|P1|Participant Flow|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
569101|NCT00594815|O1|Outcome|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
569102|NCT00594815|O1|Outcome|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
569103|NCT00594815|E1|Reported Event|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL.
569104|NCT00594685|B1|Baseline|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569105|NCT00594685|P1|Participant Flow|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569106|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569107|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569108|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569334|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569360|NCT00594425|O3|Outcome|Vehicle PDT|
569109|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569110|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569111|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569112|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569113|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569114|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569115|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569116|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569117|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569118|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569119|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569120|NCT00594685|E1|Reported Event|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
569121|NCT00594659|B4|Baseline|Total|Total of all reporting groups
569122|NCT00594659|B3|Baseline|3-tMET|"Therapist delivered motivational enhancement therapy (tMET)~Two session treatment with sessions delivered during weeks 1 and 4.~Two times per week urine drug testing.~Non-contingent incentives delivered for attending each urine testing appointment."
569123|NCT00594659|B2|Baseline|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12.~2 times per week urine drug testing.~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
569124|NCT00594659|B1|Baseline|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Nine weekly therapy sessions delivered in weeks 1-8 and week 12~2 times per week urine drug testing~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
569125|NCT00594659|P3|Participant Flow|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
569126|NCT00594659|P2|Participant Flow|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
569127|NCT00594659|P1|Participant Flow|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
569128|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment"
569129|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment~Computerized Psychotherapy : Nine session computer delivered treatment"
569130|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment~Psychotherapy : Nine session treatment"
569131|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment"
569132|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment~Computerized Psychotherapy : Nine session computer delivered treatment"
569133|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment~Psychotherapy : Nine session treatment"
569134|NCT00594659|E3|Reported Event|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
569135|NCT00594659|E2|Reported Event|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
569136|NCT00594659|E1|Reported Event|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
569137|NCT00594646|B1|Baseline|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
569138|NCT00594646|P1|Participant Flow|Group 1|Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
569139|NCT00594646|O1|Outcome|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
569140|NCT00594646|O1|Outcome|Group 1|TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
569141|NCT00594646|E1|Reported Event|Group 1|TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
569142|NCT00594568|B4|Baseline|Total|Total of all reporting groups
569143|NCT00594568|B3|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569144|NCT00594568|B2|Baseline|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569145|NCT00594568|B1|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569146|NCT00594568|P3|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569147|NCT00594568|P2|Participant Flow|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569148|NCT00594568|P1|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569149|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569150|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569151|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569152|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569153|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569154|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569155|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569156|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569157|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569158|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569159|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569160|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569161|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569162|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569163|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569164|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569165|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569166|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569167|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569168|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569169|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569170|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569171|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569172|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569173|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569174|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569175|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569176|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569177|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569178|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569179|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569180|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569181|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569182|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569183|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569184|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569185|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569186|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569187|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569188|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569189|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569190|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569191|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569192|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569193|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569194|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569195|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569196|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569197|NCT00594568|O1|Outcome|LY450139|Participants received 60 milligram LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569198|NCT00594568|O1|Outcome|LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569199|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569200|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569201|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569202|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569203|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569204|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569205|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569206|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569207|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569208|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569209|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569210|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569211|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569212|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569213|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569214|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569215|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569216|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569217|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569218|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569219|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569220|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569221|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569222|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569223|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569224|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
569225|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569226|NCT00594568|E9|Reported Event|140 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
569227|NCT00594568|E8|Reported Event|100 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.
569228|NCT00594568|E7|Reported Event|Placebo- Safety FU Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
569229|NCT00594568|E6|Reported Event|140 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569230|NCT00594568|E5|Reported Event|100 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
569231|NCT00594568|E4|Reported Event|Placebo - Delayed Start Period (DO)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
569232|NCT00594568|E3|Reported Event|140 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
569233|NCT00594568|E2|Reported Event|100 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
569234|NCT00594568|E1|Reported Event|Placebo - Initial Treatment Period (NT)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
569235|NCT00594516|B1|Baseline|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
569236|NCT00594516|P3|Participant Flow|Tapentadol ER to IR|Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
569237|NCT00594516|P2|Participant Flow|Tapentadol IR to ER|Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase
569238|NCT00594516|P1|Participant Flow|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
569239|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
569240|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
569335|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569336|NCT00594425|O3|Outcome|Vehicle PDT|
569337|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569241|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
569242|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
569243|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
569244|NCT00594516|E1|Reported Event|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
569245|NCT00594464|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
569246|NCT00594464|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
569247|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
569248|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
569249|NCT00594464|O6|Outcome|Rotigotine 16 mg/24h|
569250|NCT00594464|O5|Outcome|Rotigotine 14 mg/24h|
569251|NCT00594464|O4|Outcome|Rotigotine 12 mg/24h|
569252|NCT00594464|O3|Outcome|Rotigotine 8 mg/24h|
569253|NCT00594464|O2|Outcome|Rotigotine 6mg/24h|
569254|NCT00594464|O1|Outcome|Rotigotine 2 mg/24h|
569255|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
569256|NCT00594464|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
569257|NCT00594425|B4|Baseline|Total|Total of all reporting groups
569258|NCT00594425|B3|Baseline|Vehicle PDT|
569259|NCT00594425|B2|Baseline|80 mg/g MAL PDT|
569260|NCT00594425|B1|Baseline|40 mg/g MAL PDT|
569261|NCT00594425|P3|Participant Flow|Vehicle PDT|
569262|NCT00594425|P2|Participant Flow|80 mg/g MAL PDT|
569263|NCT00594425|P1|Participant Flow|40 mg/g MAL PDT|
569264|NCT00594425|O3|Outcome|Vehicle PDT|
569265|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569266|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569267|NCT00594425|O3|Outcome|Vehicle PDT|
569268|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569269|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569270|NCT00594425|O3|Outcome|Vehicle PDT|
569271|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569272|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569273|NCT00594425|O3|Outcome|Vehicle PDT|
569274|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569275|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569276|NCT00594425|O3|Outcome|Vehicle PDT|
569277|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569278|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569279|NCT00594425|O3|Outcome|Vehicle PDT|
569280|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569281|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569282|NCT00594425|O3|Outcome|Vehicle PDT|
569283|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569284|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569285|NCT00594425|O3|Outcome|Vehicle PDT|
569286|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569287|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569288|NCT00594425|O3|Outcome|Vehicle PDT|
569289|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569290|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569291|NCT00594425|O3|Outcome|Vehicle PDT|
569292|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569293|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569294|NCT00594425|O3|Outcome|Vehicle PDT|
569295|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569296|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569297|NCT00594425|O3|Outcome|Vehicle PDT|
569298|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569299|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569300|NCT00594425|O3|Outcome|Vehicle PDT|
569301|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569302|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569303|NCT00594425|O3|Outcome|Vehicle PDT|
569304|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569305|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569306|NCT00594425|O3|Outcome|Vehicle PDT|
569307|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569308|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569309|NCT00594425|O3|Outcome|Vehicle PDT|
569310|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569311|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569312|NCT00594425|O3|Outcome|Vehicle PDT|
569313|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569314|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569315|NCT00594425|O3|Outcome|Vehicle PDT|
569316|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569317|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569318|NCT00594425|O3|Outcome|Vehicle PDT|
569319|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569320|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569321|NCT00594425|O3|Outcome|Vehicle PDT|
569322|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569323|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569324|NCT00594425|O3|Outcome|Vehicle PDT|
569325|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569326|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569327|NCT00594425|O3|Outcome|Vehicle PDT|
569328|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569329|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569330|NCT00594425|O3|Outcome|Vehicle PDT|
569361|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569362|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569363|NCT00594425|O3|Outcome|Vehicle PDT|
569364|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569365|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569366|NCT00594425|O3|Outcome|Vehicle PDT|
569367|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
569368|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
569369|NCT00594425|E3|Reported Event|Vehicle PDT|
569370|NCT00594425|E2|Reported Event|80 mg/g MAL PDT|
569371|NCT00594425|E1|Reported Event|40 mg/g MAL PDT|
569372|NCT00594399|B3|Baseline|Total|Total of all reporting groups
569373|NCT00594399|B2|Baseline|Arm 2|Usual care from primary, womens or geriatric clinics
569374|NCT00594399|B1|Baseline|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569375|NCT00594399|P3|Participant Flow|Arm 3, Physical Activity Counseling, Reduced Dose|Upon rerandomization, individuals in this group continued to receive monthly physical activity counseling through 6 months which was then reduced to every other month during months 6-12.
569376|NCT00594399|P2|Participant Flow|Arm 2, Usual Care|Usual care from primary, womens or geriatric clinics
569377|NCT00594399|P1|Participant Flow|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569378|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569379|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569380|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569381|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569382|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569383|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569384|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569385|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569386|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569387|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569388|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569389|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569390|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569391|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569392|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569393|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569394|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
569395|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569396|NCT00594399|E2|Reported Event|Arm 2|Usual care from primary, womens or geriatric clinics
569397|NCT00594399|E1|Reported Event|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
569398|NCT00594386|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569399|NCT00594386|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569400|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569401|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569402|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569403|NCT00594386|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569404|NCT00594308|B1|Baseline|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569405|NCT00594308|P1|Participant Flow|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569406|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569407|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569408|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569409|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569410|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569411|NCT00594308|E1|Reported Event|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
569412|NCT00594256|B1|Baseline|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
569413|NCT00594256|P1|Participant Flow|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
569414|NCT00594256|O1|Outcome|Sodium Oxybate|
569415|NCT00594256|O1|Outcome|Sodium Oxybate|
569416|NCT00594256|O1|Outcome|Sodiumn Oxybate|
569417|NCT00594256|O1|Outcome|Sodium Oxybate|
569418|NCT00594256|O1|Outcome|Sodium Oxybate|
569419|NCT00594256|E1|Reported Event|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
569420|NCT00594230|B3|Baseline|Total|Total of all reporting groups
569421|NCT00594230|B2|Baseline|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569422|NCT00594230|B1|Baseline|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569423|NCT00594230|P2|Participant Flow|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569424|NCT00594230|P1|Participant Flow|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569425|NCT00594230|O2|Outcome|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569426|NCT00594230|O1|Outcome|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569427|NCT00594230|E2|Reported Event|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569428|NCT00594230|E1|Reported Event|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
569429|NCT00594204|B3|Baseline|Total|Total of all reporting groups
569430|NCT00594204|B2|Baseline|Placebo|matching placebo following the same treatment schema as the varenicline group
569431|NCT00594204|B1|Baseline|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
569432|NCT00594204|P2|Participant Flow|Placebo|matching placebo following the same treatment schema as the varenicline group
569433|NCT00594204|P1|Participant Flow|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
569434|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
569435|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
569436|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
569437|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
569438|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
569439|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
569440|NCT00594204|E2|Reported Event|Placebo|matching placebo following the same treatment schema as the varenicline group
569441|NCT00594204|E1|Reported Event|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
570373|NCT00592384|B3|Baseline|Total|Total of all reporting groups
569442|NCT00594178|B1|Baseline|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
569443|NCT00594178|P1|Participant Flow|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
569444|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
569445|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
569446|NCT00594178|E1|Reported Event|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
569447|NCT00594165|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569448|NCT00594165|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569449|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569450|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569451|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569452|NCT00594165|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
569453|NCT00594100|B1|Baseline|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569454|NCT00594100|P1|Participant Flow|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569455|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569456|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569457|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569458|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569459|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569460|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569461|NCT00594100|E1|Reported Event|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
569632|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569462|NCT00594061|B1|Baseline|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
569463|NCT00594061|P1|Participant Flow|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
569464|NCT00594061|O1|Outcome|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
569465|NCT00594061|O1|Outcome|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
569466|NCT00594061|E1|Reported Event|Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation|"There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.~Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side."
569467|NCT00594035|B3|Baseline|Total|Total of all reporting groups
569468|NCT00594035|B2|Baseline|Standard of Care|Subjects who receive standard or care meathods of dural sealing
569469|NCT00594035|B1|Baseline|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
569470|NCT00594035|P2|Participant Flow|Standard of Care|Subjects who receive standard or care meathods of dural sealing
569471|NCT00594035|P1|Participant Flow|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
569472|NCT00594035|O2|Outcome|Standard of Care|Subjects who receive standard or care meathods of dural sealing
569473|NCT00594035|O1|Outcome|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
569474|NCT00594035|E2|Reported Event|Standard of Care|Subjects who receive standard or care meathods of dural sealing
569475|NCT00594035|E1|Reported Event|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
569476|NCT00594022|B3|Baseline|Total|Total of all reporting groups
569477|NCT00594022|B2|Baseline|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569478|NCT00594022|B1|Baseline|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569479|NCT00594022|P2|Participant Flow|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569480|NCT00594022|P1|Participant Flow|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569481|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569516|NCT00593957|O1|Outcome|Dextromethorphan (DM)1 EEG Spike Counts at Baseline|Dextromethorphan(DM)I group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at baseline.
569482|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569483|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569484|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569485|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569486|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569487|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569488|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569489|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569490|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569491|NCT00594022|E2|Reported Event|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
569492|NCT00594022|E1|Reported Event|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
569493|NCT00593957|B4|Baseline|Total|Total of all reporting groups
569633|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569634|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
571613|NCT00588354|B3|Baseline|Total|Total of all reporting groups
569494|NCT00593957|B3|Baseline|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569495|NCT00593957|B2|Baseline|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569496|NCT00593957|B1|Baseline|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569497|NCT00593957|P3|Participant Flow|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569498|NCT00593957|P2|Participant Flow|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569499|NCT00593957|P1|Participant Flow|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569500|NCT00593957|O2|Outcome|Total Sample SSI Mean Score at 6 Months|Study Sample Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
569501|NCT00593957|O1|Outcome|Total Sample SSI Mean Score at Baseline|Study Sample Screen for Social Interaction (SSI) mean core at baseline.
569502|NCT00593957|O6|Outcome|DM3 (5.0 mg/kg/Day) SSI 6 Months|DM3(5.0) mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
569503|NCT00593957|O5|Outcome|DM2 (2.5 mg/kg/Day) SSI 6 Months|DM2( 2.5 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
569504|NCT00593957|O4|Outcome|DM1( 0.25 mg/kg /Day) SSI 6 Months|DM1( 0.25 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
569505|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 5mg/kg/day treatment arm.
569506|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 2.5 mg/kg/day treatment arm.
569507|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 0.25 mg/kg per day treatment arm.
569508|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569509|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569510|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569511|NCT00593957|O6|Outcome|DM3 EEG Spike Counts at 6 Months|DM3 group received Dextromethorphan 5mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at 6 months.
569512|NCT00593957|O5|Outcome|DM2 EEG Spike Counts at 6 Months|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at 6 months.
569513|NCT00593957|O4|Outcome|DM1 EEG Spike Count at 6 Months|DM1 group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at 6 months.
569514|NCT00593957|O3|Outcome|DM3 EEG Spike Counts at Baseline|"DM3 group received Dextromethorphan 5mg/kg/day.~The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at baseline."
569515|NCT00593957|O2|Outcome|DM2 EEG Spike Counts at Baseline|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at baseline.
570071|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
569517|NCT00593957|E3|Reported Event|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569518|NCT00593957|E2|Reported Event|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569519|NCT00593957|E1|Reported Event|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
569520|NCT00593918|B3|Baseline|Total|Total of all reporting groups
569521|NCT00593918|B2|Baseline|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
569522|NCT00593918|B1|Baseline|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
569523|NCT00593918|P2|Participant Flow|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
569524|NCT00593918|P1|Participant Flow|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
569525|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
569526|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
569527|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
569528|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
569529|NCT00593918|E2|Reported Event|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
569530|NCT00593918|E1|Reported Event|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
569531|NCT00593866|B1|Baseline|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
569532|NCT00593866|P1|Participant Flow|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
569533|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
569534|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
569535|NCT00593866|E1|Reported Event|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
569577|NCT00593814|O1|Outcome|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
569536|NCT00593840|B1|Baseline|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
569537|NCT00593840|P1|Participant Flow|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
569538|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
569539|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
569540|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
569541|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
569542|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
569543|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
569544|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
569545|NCT00593840|E1|Reported Event|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
569546|NCT00593827|B3|Baseline|Total|Total of all reporting groups
569547|NCT00593827|B2|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569548|NCT00593827|B1|Baseline|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569549|NCT00593827|P2|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569550|NCT00593827|P1|Participant Flow|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569551|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569552|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569553|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569554|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569555|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569556|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569557|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569558|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569559|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569560|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569561|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569562|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569563|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569564|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569565|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569566|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569567|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569568|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569569|NCT00593827|E2|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
569570|NCT00593827|E1|Reported Event|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
569571|NCT00593814|B3|Baseline|Total|Total of all reporting groups
569572|NCT00593814|B2|Baseline|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
569573|NCT00593814|B1|Baseline|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
569574|NCT00593814|P2|Participant Flow|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
569575|NCT00593814|P1|Participant Flow|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
569576|NCT00593814|O2|Outcome|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
569578|NCT00593814|O2|Outcome|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
569579|NCT00593814|O1|Outcome|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
569580|NCT00593814|E2|Reported Event|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
569581|NCT00593814|E1|Reported Event|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
569582|NCT00593736|B5|Baseline|Total|Total of all reporting groups
569583|NCT00593736|B4|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569584|NCT00593736|B3|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569585|NCT00593736|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569586|NCT00593736|B1|Baseline|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569587|NCT00593736|P4|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569588|NCT00593736|P3|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569589|NCT00593736|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569590|NCT00593736|P1|Participant Flow|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569591|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569592|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569593|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569594|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569595|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569596|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569597|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569598|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569599|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569600|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569601|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569602|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569603|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569604|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569605|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569606|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569607|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569608|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569609|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569610|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569611|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569612|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569613|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569614|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569615|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569616|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569617|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569618|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569619|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569620|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569621|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569622|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569623|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569624|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569625|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569626|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569627|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569628|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569629|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569630|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569631|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569635|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569636|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569637|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569638|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569639|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569640|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569641|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569642|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569643|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569644|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569645|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569646|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569647|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569648|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569649|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569650|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569651|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569652|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569653|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569654|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569655|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569656|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569657|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569658|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569659|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569660|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569661|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569662|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569663|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569664|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569665|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569666|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569667|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569668|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569669|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569670|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569671|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569672|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569673|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569674|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569675|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569676|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569677|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569678|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569679|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569680|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569681|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569682|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569683|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569684|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569685|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569686|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569687|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569688|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569689|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569690|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569691|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569692|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569693|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569694|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569695|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569696|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569697|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569698|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569699|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569700|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569701|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569702|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569703|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569704|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569705|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569706|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569707|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569708|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569709|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569710|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569711|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569712|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569713|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569714|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569715|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569716|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569717|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569718|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569719|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569720|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569721|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569722|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569723|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569724|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569725|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569726|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569727|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569728|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569729|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569730|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569731|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569732|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569733|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569734|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569735|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569736|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569737|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569738|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569739|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569740|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569741|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569742|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569743|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569744|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569745|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569746|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569747|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569748|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569749|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569750|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569751|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569752|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569753|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569754|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569755|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569756|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569757|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569758|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569759|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569760|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569761|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569762|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569763|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569764|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569765|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569766|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569767|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569768|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569769|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569770|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569771|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569772|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569773|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569774|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569775|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569776|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569777|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569778|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569779|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569780|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569781|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569782|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569783|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569784|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569785|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569786|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569787|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569788|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569789|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569790|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569791|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569792|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569793|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569794|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569795|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569796|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569797|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569798|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569799|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569800|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569801|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569802|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569803|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569804|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569805|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569806|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569807|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569808|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569809|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569810|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569811|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569812|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569813|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569814|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569815|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569816|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569817|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569818|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569819|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569820|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569821|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569822|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569823|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569824|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569825|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569826|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569827|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569828|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569829|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569830|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569831|NCT00593736|E4|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
569832|NCT00593736|E3|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
569833|NCT00593736|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
569834|NCT00593736|E1|Reported Event|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
569835|NCT00593684|B3|Baseline|Total|Total of all reporting groups
569836|NCT00593684|B2|Baseline|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
569837|NCT00593684|B1|Baseline|Algidex Patch|
569838|NCT00593684|P2|Participant Flow|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
569839|NCT00593684|P1|Participant Flow|Algidex Patch|
569840|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
569841|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
569842|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
569843|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
569844|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
569845|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
569846|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
569847|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
569848|NCT00593684|E2|Reported Event|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
569849|NCT00593684|E1|Reported Event|Algidex Patch|
569850|NCT00593645|B1|Baseline|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569851|NCT00593645|P1|Participant Flow|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
573837|NCT00580866|O2|Outcome|PT Only Group|
569852|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569853|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569854|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569855|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569856|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569857|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569858|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569859|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569860|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569861|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569862|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569863|NCT00593645|E1|Reported Event|Arm 1|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
569864|NCT00593606|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569865|NCT00593606|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569866|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569867|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569868|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569869|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569870|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
570072|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
569871|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569872|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569873|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569874|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569875|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569876|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569877|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569878|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569879|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569880|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569881|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569882|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569883|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569884|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569885|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569886|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569887|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569888|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569889|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569890|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569891|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569892|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569893|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569894|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569895|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569896|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569897|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569898|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569899|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569900|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569901|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569902|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
575393|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
569903|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569904|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569905|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569906|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569907|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569908|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569909|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569910|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569911|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569912|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569913|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569914|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569915|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569916|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569917|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569918|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569919|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569920|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569921|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569922|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569923|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569924|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569925|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569926|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569927|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569928|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569929|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569930|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569931|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569932|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569933|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569934|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
575746|NCT00577135|O4|Outcome|High Intensification|
569935|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569936|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569937|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569938|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569939|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569940|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569941|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569942|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569943|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569944|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569945|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569946|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569947|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569948|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569949|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569950|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569951|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569952|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569953|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569954|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569955|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569956|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569957|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569958|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569959|NCT00593606|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
569960|NCT00593554|B3|Baseline|Total|Total of all reporting groups
569961|NCT00593554|B2|Baseline|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569962|NCT00593554|B1|Baseline|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569963|NCT00593554|P2|Participant Flow|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569964|NCT00593554|P1|Participant Flow|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569992|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570073|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
569965|NCT00593554|O2|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569966|NCT00593554|O1|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569967|NCT00593554|O2|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569968|NCT00593554|O1|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569969|NCT00593554|O2|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569970|NCT00593554|O1|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569971|NCT00593554|O2|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569972|NCT00593554|O1|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569973|NCT00593554|O2|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569974|NCT00593554|O1|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569975|NCT00593554|O2|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569976|NCT00593554|O1|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569977|NCT00593554|O2|Outcome|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569978|NCT00593554|O1|Outcome|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569979|NCT00593554|E2|Reported Event|Treatment With Palifermin|"Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2~Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"
569980|NCT00593554|E1|Reported Event|Treatment Without Paliferim|"Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;~Total Body Irradiation: 8 Gy on Day -9~Thiotepa: 5 mg/kg/d on Day -8 to -7~Fludarabine: 40 mg/m2/d on Day -6 to -3~Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2"
569981|NCT00593450|B5|Baseline|Total|Total of all reporting groups
569982|NCT00593450|B4|Baseline|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569983|NCT00593450|B3|Baseline|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569984|NCT00593450|B2|Baseline|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
569985|NCT00593450|B1|Baseline|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
569986|NCT00593450|P4|Participant Flow|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569987|NCT00593450|P3|Participant Flow|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569988|NCT00593450|P2|Participant Flow|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
569989|NCT00593450|P1|Participant Flow|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
569990|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569991|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570069|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
569993|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
569994|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569995|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569996|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
569997|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
569998|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
569999|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570000|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570001|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570002|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570003|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570004|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570005|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570006|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570007|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570008|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570009|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570010|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570011|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570012|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570013|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570014|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570015|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570016|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570017|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570018|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570019|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570020|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570021|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570022|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570023|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570024|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570025|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570026|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570027|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570070|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570028|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570029|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570030|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570031|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570032|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570033|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570034|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570035|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570036|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570037|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570038|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570039|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570040|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570041|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570042|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570043|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570044|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570045|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570046|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570047|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570048|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570049|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570050|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570051|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570052|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570053|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570054|NCT00593450|E4|Reported Event|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570055|NCT00593450|E3|Reported Event|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
570056|NCT00593450|E2|Reported Event|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
570057|NCT00593450|E1|Reported Event|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
570058|NCT00593385|B1|Baseline|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570059|NCT00593385|P1|Participant Flow|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570060|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570061|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570062|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570063|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570064|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570065|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570066|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570067|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥1 ICAST stent
570068|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570074|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570075|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570076|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570077|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570078|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570079|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570080|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570081|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570082|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570083|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570084|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570085|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570086|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570087|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570088|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570089|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570090|NCT00593385|O1|Outcome|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570091|NCT00593385|O1|Outcome|iCAST Covered Stent|"Device: iCAST covered stent~Implantation of ≥1 iCAST stents"
570092|NCT00593385|E1|Reported Event|Device: ICAST Covered Stent|Implantation of ≥ 1 ICAST stent
570093|NCT00593372|B3|Baseline|Total|Total of all reporting groups
570094|NCT00593372|B2|Baseline|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
570095|NCT00593372|B1|Baseline|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
570096|NCT00593372|P2|Participant Flow|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
570097|NCT00593372|P1|Participant Flow|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
570098|NCT00593372|O2|Outcome|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
570099|NCT00593372|O1|Outcome|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
570100|NCT00593372|E2|Reported Event|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
570101|NCT00593372|E1|Reported Event|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
570102|NCT00593346|B1|Baseline|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570103|NCT00593346|P1|Participant Flow|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570104|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570105|NCT00593346|O1|Outcome|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570106|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570107|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570108|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570109|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570110|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570111|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570112|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570214|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570113|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570114|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570115|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570116|NCT00593346|E1|Reported Event|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
570117|NCT00593333|B3|Baseline|Total|Total of all reporting groups
570118|NCT00593333|B2|Baseline|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
570119|NCT00593333|B1|Baseline|Standard Treatment|Pirformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail or an Antegrade Femoral Nail.
570120|NCT00593333|P2|Participant Flow|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
570121|NCT00593333|P1|Participant Flow|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
570122|NCT00593333|O2|Outcome|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
570123|NCT00593333|O1|Outcome|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
570124|NCT00593333|E2|Reported Event|Group B|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
570125|NCT00593333|E1|Reported Event|Group A|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
570126|NCT00593320|B3|Baseline|Total|Total of all reporting groups
570127|NCT00593320|B2|Baseline|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
570128|NCT00593320|B1|Baseline|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
570129|NCT00593320|P2|Participant Flow|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
570130|NCT00593320|P1|Participant Flow|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
570131|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
570132|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
570133|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
570134|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
570135|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
570136|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
570137|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
570138|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
570139|NCT00593320|E2|Reported Event|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
570140|NCT00593320|E1|Reported Event|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
570141|NCT00593112|B3|Baseline|Total|Total of all reporting groups
570142|NCT00593112|B2|Baseline|Control|Healthy Volunteer Control group
570143|NCT00593112|B1|Baseline|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
570144|NCT00593112|P2|Participant Flow|Control|Healthy Volunteer Control group
570145|NCT00593112|P1|Participant Flow|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
570146|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
570147|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
570148|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
570149|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
570150|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
570151|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
570152|NCT00593112|E2|Reported Event|Control|Healthy Volunteer Control group
570153|NCT00593112|E1|Reported Event|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
570154|NCT00592943|B3|Baseline|Total|Total of all reporting groups
570155|NCT00592943|B2|Baseline|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
570215|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
570156|NCT00592943|B1|Baseline|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
570157|NCT00592943|P2|Participant Flow|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
570158|NCT00592943|P1|Participant Flow|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
570159|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
570160|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
570161|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
570162|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
570163|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
570164|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
570165|NCT00592943|E2|Reported Event|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
570166|NCT00592943|E1|Reported Event|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
570167|NCT00592904|B5|Baseline|Total|Total of all reporting groups
570168|NCT00592904|B4|Baseline|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570169|NCT00592904|B3|Baseline|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570170|NCT00592904|B2|Baseline|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570171|NCT00592904|B1|Baseline|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570172|NCT00592904|P4|Participant Flow|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570173|NCT00592904|P3|Participant Flow|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570174|NCT00592904|P2|Participant Flow|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570175|NCT00592904|P1|Participant Flow|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570176|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570177|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570178|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570179|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570180|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570181|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570216|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570217|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570218|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
570182|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570183|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570184|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570185|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570186|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570187|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570188|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570189|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570190|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570191|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570192|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570193|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570194|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570195|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
570196|NCT00592904|E4|Reported Event|Post Herpetic Neuralgia|The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.
570197|NCT00592904|E3|Reported Event|Painful Diabetic Neuropathy|The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.
570198|NCT00592904|E2|Reported Event|Perampanel|The participants that had previously received perampanel during the double-blind study.
570199|NCT00592904|E1|Reported Event|Placebo|The participants who had previously received placebo during the double-blind study.
570200|NCT00592852|B1|Baseline|Fluoxetine|
570201|NCT00592852|P1|Participant Flow|Fluoxetine|
570202|NCT00592852|O1|Outcome|Fluoxetine|
570203|NCT00592852|O1|Outcome|Fluoxetine|
570204|NCT00592852|E1|Reported Event|Fluoxetine|
570205|NCT00592839|B4|Baseline|Total|Total of all reporting groups
570206|NCT00592839|B3|Baseline|Placebo Daily|Placebo tablet daily orally
570207|NCT00592839|B2|Baseline|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570208|NCT00592839|B1|Baseline|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570209|NCT00592839|P3|Participant Flow|Placebo Daily|Placebo tablet daily orally
570210|NCT00592839|P2|Participant Flow|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570211|NCT00592839|P1|Participant Flow|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570212|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
570213|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570219|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570220|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570221|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
570222|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570223|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570224|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
570225|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570226|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570227|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
570228|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570229|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570230|NCT00592839|E3|Reported Event|Placebo Daily|Placebo tablet daily orally
570231|NCT00592839|E2|Reported Event|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
570232|NCT00592839|E1|Reported Event|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
570233|NCT00592774|B6|Baseline|Total|Total of all reporting groups
570234|NCT00592774|B5|Baseline|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570235|NCT00592774|B4|Baseline|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570236|NCT00592774|B3|Baseline|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570237|NCT00592774|B2|Baseline|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570238|NCT00592774|B1|Baseline|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570239|NCT00592774|P5|Participant Flow|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570240|NCT00592774|P4|Participant Flow|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570241|NCT00592774|P3|Participant Flow|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570242|NCT00592774|P2|Participant Flow|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570243|NCT00592774|P1|Participant Flow|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570244|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570245|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570246|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570247|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570248|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570249|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570250|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570251|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570252|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570253|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570254|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570255|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570256|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570257|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570258|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570259|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570260|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570261|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570262|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570263|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570264|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570265|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570266|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570267|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570268|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570269|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570270|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570271|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570272|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570273|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570274|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570275|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570276|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570277|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570278|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570279|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570280|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570281|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570282|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570319|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
570320|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
570283|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570284|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570285|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570286|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570287|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570288|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570289|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570290|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570291|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570292|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570293|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570294|NCT00592774|E5|Reported Event|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570295|NCT00592774|E4|Reported Event|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
570296|NCT00592774|E3|Reported Event|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570297|NCT00592774|E2|Reported Event|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
570298|NCT00592774|E1|Reported Event|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
570299|NCT00592761|B1|Baseline|Entire Study Population|This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.
570300|NCT00592761|P2|Participant Flow|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
570301|NCT00592761|P1|Participant Flow|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
570302|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
570303|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
570304|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
570305|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
570306|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
570307|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
570308|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
570309|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
570310|NCT00592761|E2|Reported Event|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
570311|NCT00592761|E1|Reported Event|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
570312|NCT00592683|B3|Baseline|Total|Total of all reporting groups
570313|NCT00592683|B2|Baseline|Aripiprazole + Placebo|treatment with aripiprazole + placebo
570314|NCT00592683|B1|Baseline|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
570315|NCT00592683|P2|Participant Flow|Aripiprazole + Placebo|treatment with aripiprazole + placebo
570316|NCT00592683|P1|Participant Flow|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
570317|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
570318|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
570321|NCT00592683|E2|Reported Event|Aripiprazole + Placebo|treatment with aripiprazole + placebo
570322|NCT00592683|E1|Reported Event|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
570323|NCT00592631|B3|Baseline|Total|Total of all reporting groups
570324|NCT00592631|B2|Baseline|Sham|Subjects used SHAM set at 0-2 cmH20 for 7-10 nights
570325|NCT00592631|B1|Baseline|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
570326|NCT00592631|P2|Participant Flow|Sham Treatment|Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
570327|NCT00592631|P1|Participant Flow|Continuous Positivie Airway Pressure|Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment.
570328|NCT00592631|O2|Outcome|Sham|Subjects used sham set at 0-2 cmH20 for 7-10 nights
570329|NCT00592631|O1|Outcome|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
570330|NCT00592631|E2|Reported Event|Sham|
570331|NCT00592631|E1|Reported Event|Continuous Positive Airway Pressure|
570332|NCT00592488|B3|Baseline|Total|Total of all reporting groups
570333|NCT00592488|B2|Baseline|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
570334|NCT00592488|B1|Baseline|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
570335|NCT00592488|P2|Participant Flow|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
570336|NCT00592488|P1|Participant Flow|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
570337|NCT00592488|O2|Outcome|ALC Then Placebo|"Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours~Acetyl-L-Carnitine: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours"
570338|NCT00592488|O1|Outcome|Placebo Then ALC|"Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours~Acetyl-L-Carnitine: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours"
570339|NCT00592488|O2|Outcome|ALC Then Placebo|"Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours~Acetyl-L-Carnitine: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours"
570340|NCT00592488|O1|Outcome|Placebo Then ALC|"Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours~Acetyl-L-Carnitine: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours"
570341|NCT00592488|O2|Outcome|Placebo Then Acetyl-L-Carnitine (ALC)|Placebo for hours 0-6 then ALC for hours 6-18
570342|NCT00592488|O1|Outcome|Acetyl-L-Carnitine (ALC) Then Placebo|ALC for hours 0-12 and placebo hours 12-18
570343|NCT00592488|E2|Reported Event|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
570344|NCT00592488|E1|Reported Event|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
570345|NCT00592475|B4|Baseline|Total|Total of all reporting groups
570346|NCT00592475|B3|Baseline|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570347|NCT00592475|B2|Baseline|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570348|NCT00592475|B1|Baseline|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570349|NCT00592475|P3|Participant Flow|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570350|NCT00592475|P2|Participant Flow|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570351|NCT00592475|P1|Participant Flow|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570352|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570353|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570354|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570355|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570356|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570357|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570358|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570359|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570360|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570361|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570362|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570363|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570364|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570365|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570366|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570367|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570368|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570369|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570370|NCT00592475|E3|Reported Event|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
570371|NCT00592475|E2|Reported Event|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
570372|NCT00592475|E1|Reported Event|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
570374|NCT00592384|B2|Baseline|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
570375|NCT00592384|B1|Baseline|Placebo Control|placebo: identically encapsulated inactive substance
570376|NCT00592384|P2|Participant Flow|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
570377|NCT00592384|P1|Participant Flow|Placebo Control|placebo: identically encapsulated inactive substance
570378|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
570379|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
570380|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
570381|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
570382|NCT00592384|E2|Reported Event|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
570383|NCT00592384|E1|Reported Event|Placebo Control|placebo: identically encapsulated inactive substance
570384|NCT00592358|B1|Baseline|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
570385|NCT00592358|P1|Participant Flow|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
570386|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
570387|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
570388|NCT00592358|E1|Reported Event|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
570389|NCT00592319|B3|Baseline|Total|Total of all reporting groups
570390|NCT00592319|B2|Baseline|Experimental|treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases
570391|NCT00592319|B1|Baseline|Control|"treated with routine surgery (CO2 laser or cold microsurgery), in 15 cases"
570392|NCT00592319|P2|Participant Flow|Experimental|once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months
570393|NCT00592319|P1|Participant Flow|Control|"once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or cold surgery with micro-instruments), in 15 subjects"
570394|NCT00592319|O2|Outcome|Experienment|treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months
570395|NCT00592319|O1|Outcome|Control|"treated with once-time routine surgery (CO2 laser or cold microsurgery)"
570396|NCT00592319|O2|Outcome|Experiment|treated with both of once-time PDL and 9-month Celebrex
570397|NCT00592319|O1|Outcome|Control|treated with once-time routine surgery
570398|NCT00592319|E2|Reported Event|Control|treatd with CO2 laser or microsurgery
570399|NCT00592319|E1|Reported Event|Experiment|treated with both of PDL and Celecoxib
570400|NCT00592176|B1|Baseline|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
570401|NCT00592176|P1|Participant Flow|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
570402|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
570403|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
570404|NCT00592176|E1|Reported Event|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
570405|NCT00592124|B7|Baseline|Total|Total of all reporting groups
570406|NCT00592124|B6|Baseline|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570407|NCT00592124|B5|Baseline|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570408|NCT00592124|B4|Baseline|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570409|NCT00592124|B3|Baseline|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570410|NCT00592124|B2|Baseline|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570411|NCT00592124|B1|Baseline|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570412|NCT00592124|P6|Participant Flow|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570413|NCT00592124|P5|Participant Flow|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570467|NCT00592072|B1|Baseline|Overall Number of Subjects|12 subjects started the study and 10 completed the study, however 11 subjects are reported in the baseline characteristics because one subjects withdrew before baseline data was collected.
570414|NCT00592124|P4|Participant Flow|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570415|NCT00592124|P3|Participant Flow|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570416|NCT00592124|P2|Participant Flow|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570417|NCT00592124|P1|Participant Flow|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
570418|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570419|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570420|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570421|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570422|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570423|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
570424|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570425|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570426|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570427|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570428|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570429|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570430|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570431|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570432|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570433|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570434|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570435|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570436|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570437|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570438|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570439|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570440|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570441|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570442|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570443|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570444|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570445|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570446|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570447|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570448|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570449|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570450|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570451|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570452|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570453|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570454|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570455|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570456|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570457|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
570458|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570459|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570460|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
570461|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570462|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570463|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
570464|NCT00592124|E3|Reported Event|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
570465|NCT00592124|E2|Reported Event|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
570466|NCT00592124|E1|Reported Event|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
570502|NCT00591864|B1|Baseline|Study Participants|There are no arms or subgroups in this study.
575747|NCT00577135|O3|Outcome|Low Intensification|
570468|NCT00592072|P2|Participant Flow|Placebo Intervention First, Then MCT Intervention|A total of 40 grams of cherry-flavored water sweetened with sucralose is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
570469|NCT00592072|P1|Participant Flow|MCT Intervention First, Then Placebo|A total of 40 grams of medium-chain triglycerides (derived from coconut oil containing 67% octanoate, 27% decanaote, and 6% other fatty acids) is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
570470|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570471|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570472|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570473|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570474|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570475|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570476|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570477|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570478|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570479|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570480|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570481|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570482|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570483|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570484|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570485|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570486|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
570487|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
570488|NCT00592072|E2|Reported Event|Placebo Intervention|
570489|NCT00592072|E1|Reported Event|MCT Intervention|
570490|NCT00592007|B1|Baseline|Fulvestrant and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
570491|NCT00592007|P1|Participant Flow|Fulvestrand and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib : Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
570492|NCT00592007|O1|Outcome|Arm A|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
570493|NCT00592007|O1|Outcome|Arm A|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
570494|NCT00592007|E1|Reported Event|A: Fulvestrant and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
570495|NCT00591942|B1|Baseline|Group 1|Note only one group is listed since EACH subject received TWO crowns. AS cross-over design, ONE crown had the VivaGlass cement and the second crown (in the same subject) had the Multi-link cement.
570496|NCT00591942|P2|Participant Flow|Multilink Cement|Cross over design, two crowns per subject, one crown cemented with Multilink/subject
570497|NCT00591942|P1|Participant Flow|VivaGlass Cement|Cross over design, two crowns per subject, one crown cemented with VivaGlass/subject
570498|NCT00591942|O2|Outcome|Ivoclar/Vivadent Composite Resin Cement|Ivoclar/Vivadent Composite Resin Cement for ceramic crowns and 3-unit dental bridge
570499|NCT00591942|O1|Outcome|Ivoclar Vivaglass CEM IC Cement|Ivoclar Vivaglass CEM IC cement for ceramic crowns and 3-unit dental bridge
570500|NCT00591942|E2|Reported Event|Ivoclar/Vivadent Composite Resin|Ivoclar/Vivadent Composite Resin Cement for ceramic crowns and 3-unit dental bridge
570501|NCT00591942|E1|Reported Event|Ivoclar Vivaglass CEM IC|Ivoclar Vivaglass CEM IC cement for ceramic crowns and 3-unit dental bridge
570503|NCT00591864|P1|Participant Flow|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
570504|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
570505|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
570506|NCT00591864|O1|Outcome|Study Participants|There are no arms or subgroups in this study.
570507|NCT00591864|E1|Reported Event|Study Participants|There are no arms or subgroups in this study.
570508|NCT00591851|B1|Baseline|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
570509|NCT00591851|P1|Participant Flow|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
570510|NCT00591851|O1|Outcome|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
570511|NCT00591851|E1|Reported Event|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
570512|NCT00591825|B5|Baseline|Total|Total of all reporting groups
570513|NCT00591825|B4|Baseline|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
570514|NCT00591825|B3|Baseline|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
570515|NCT00591825|B2|Baseline|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
570516|NCT00591825|B1|Baseline|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
570517|NCT00591825|P4|Participant Flow|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
570518|NCT00591825|P3|Participant Flow|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
570519|NCT00591825|P2|Participant Flow|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
570520|NCT00591825|P1|Participant Flow|Non-Phobic Control - Placebo|Participants without phobia given one administration placebo.
570521|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
570522|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
570523|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
570524|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
570525|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg placebo.
570526|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
570527|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
570528|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
570529|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
570530|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
570531|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
570532|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
570533|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants without phobia given one administration of 100 mg D-cycloserine.
570534|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
570535|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
570536|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
570537|NCT00591825|O4|Outcome|Placebo Control|Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
570538|NCT00591825|O3|Outcome|Placebo Phobic|Participants with phobia who were randomized to the Placebo group were given one administration of placebo.
570539|NCT00591825|O2|Outcome|DCS Control|Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
570540|NCT00591825|O1|Outcome|DCS Phobic|Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
570541|NCT00591825|E4|Reported Event|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
570542|NCT00591825|E3|Reported Event|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
570543|NCT00591825|E2|Reported Event|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
570544|NCT00591825|E1|Reported Event|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
570545|NCT00591773|B4|Baseline|Total|Total of all reporting groups
570546|NCT00591773|B3|Baseline|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570547|NCT00591773|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570548|NCT00591773|B1|Baseline|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570549|NCT00591773|P3|Participant Flow|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570550|NCT00591773|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570551|NCT00591773|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570552|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570553|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570554|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570555|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570556|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570557|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570558|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570559|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570560|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570561|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570562|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570563|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570564|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570565|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570566|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570567|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570568|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570569|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570570|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570571|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570572|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570573|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570574|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570575|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570576|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570577|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570578|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570579|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570580|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570581|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570582|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570583|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570584|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570585|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570586|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570587|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570588|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570589|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570590|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570591|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570592|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570593|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570594|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570595|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570596|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570597|NCT00591773|E3|Reported Event|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570598|NCT00591773|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570599|NCT00591773|E1|Reported Event|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
570600|NCT00591760|B3|Baseline|Total|Total of all reporting groups
570601|NCT00591760|B2|Baseline|Control|Optimal CHF treatment
570602|NCT00591760|B1|Baseline|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
570603|NCT00591760|P2|Participant Flow|Control|Optimal CHF treatment
570604|NCT00591760|P1|Participant Flow|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
570605|NCT00591760|O2|Outcome|Control|Optimal CHF treatment
570606|NCT00591760|O1|Outcome|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
570607|NCT00591760|E2|Reported Event|Control|Optimal CHF treatment
570608|NCT00591760|E1|Reported Event|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
570609|NCT00591734|B1|Baseline|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
570610|NCT00591734|P1|Participant Flow|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
570611|NCT00591734|O1|Outcome|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
570612|NCT00591734|E1|Reported Event|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
570613|NCT00591721|B3|Baseline|Total|Total of all reporting groups
570614|NCT00591721|B2|Baseline|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
570615|NCT00591721|B1|Baseline|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
570616|NCT00591721|P2|Participant Flow|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
570617|NCT00591721|P1|Participant Flow|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
570618|NCT00591721|O2|Outcome|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
570619|NCT00591721|O1|Outcome|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
570620|NCT00591721|E2|Reported Event|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
570621|NCT00591721|E1|Reported Event|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
570622|NCT00591591|B3|Baseline|Total|Total of all reporting groups
570623|NCT00591591|B2|Baseline|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570624|NCT00591591|B1|Baseline|Controls|Healthy controls
570625|NCT00591591|P2|Participant Flow|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570626|NCT00591591|P1|Participant Flow|Controls|Healthy controls
570627|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570628|NCT00591591|O1|Outcome|Controls|Healthy controls
570629|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570630|NCT00591591|O1|Outcome|Controls|Healthy controls
570631|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570632|NCT00591591|O1|Outcome|Controls|Healthy controls
570633|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570634|NCT00591591|O1|Outcome|Controls|Healthy controls
570635|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570636|NCT00591591|O1|Outcome|Controls|Healthy controls
570637|NCT00591591|E2|Reported Event|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
570638|NCT00591591|E1|Reported Event|Controls|Healthy controls
570639|NCT00591578|B4|Baseline|Total|Total of all reporting groups
570640|NCT00591578|B3|Baseline|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570641|NCT00591578|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570642|NCT00591578|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570643|NCT00591578|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570644|NCT00591578|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570645|NCT00591578|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570646|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570647|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570648|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570649|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570650|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570651|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570803|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570652|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570653|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570654|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570655|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570656|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570657|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570658|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570659|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570660|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570661|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570662|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570663|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570664|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570665|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570666|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570667|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570668|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570669|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570670|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570671|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570672|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570673|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570674|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570675|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570676|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570677|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570678|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570679|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570680|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570681|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570682|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570683|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570684|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570685|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570686|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570687|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570688|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570689|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
570690|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
570691|NCT00591578|E4|Reported Event|Open Label Extension|Azilsartan medoxomil 40 mg, tablets, orally, independent of participant’s double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).
570692|NCT00591578|E3|Reported Event|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
570693|NCT00591578|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570694|NCT00591578|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
570695|NCT00591565|B1|Baseline|Acamprosate|acamprosate tablets
570696|NCT00591565|P1|Participant Flow|Acamprosate|acamprosate tablets
570697|NCT00591565|O1|Outcome|Acamprosate|
570698|NCT00591565|E1|Reported Event|Acamprosate|acamprosate tablets
570699|NCT00591370|B1|Baseline|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
570700|NCT00591370|P1|Participant Flow|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
570701|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
570702|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
570703|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
570704|NCT00591370|E1|Reported Event|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
570705|NCT00591344|B3|Baseline|Total|Total of all reporting groups
570706|NCT00591344|B2|Baseline|2 Flexibility Training|"25 PD subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
570707|NCT00591344|B1|Baseline|1 Progressive Resistance Training|"25 PD Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
570708|NCT00591344|P2|Participant Flow|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
570709|NCT00591344|P1|Participant Flow|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
570710|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment- L-dopa equilivent-mg/day
570711|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- L-dopa equilivent-mg/day
570712|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - on medication UPDRS part III, motor subscale score
570713|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- on medication UPDRS part III, motor subscale score
570714|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - off medication UPDRS part III, motor subscale score
570715|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- off medication UPDRS part III, motor subscale score
570716|NCT00591344|E2|Reported Event|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
570758|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570759|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
575748|NCT00577135|O2|Outcome|Continuous Infusion|
570717|NCT00591344|E1|Reported Event|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
570718|NCT00591305|B3|Baseline|Total|Total of all reporting groups
570719|NCT00591305|B2|Baseline|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects~585 nm pulsed dye laser: once-time PDL"
570720|NCT00591305|B1|Baseline|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects~diindolylmethane (DIM): 3-month DIM~585 nm pulsed dye laser: once-time PDL"
570721|NCT00591305|P2|Participant Flow|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects~585 nm pulsed dye laser: once-time PDL"
570722|NCT00591305|P1|Participant Flow|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects~diindolylmethane (DIM): 3-month DIM~585 nm pulsed dye laser: once-time PDL"
570723|NCT00591305|O2|Outcome|Placebo|laser only without DIM
570724|NCT00591305|O1|Outcome|Intervention|laser+diatary DIM
570725|NCT00591305|O2|Outcome|Placebo|laser only without DIM
570726|NCT00591305|O1|Outcome|Intervention|laser+diatary DIM
570727|NCT00591305|O2|Outcome|Placebo|laser only without DIM
570728|NCT00591305|O1|Outcome|Intervention|laser+dietary DIM
570729|NCT00591305|E2|Reported Event|PDL+Placebo Pill|once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
570730|NCT00591305|E1|Reported Event|PDL+DIM Pill|once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects
570731|NCT00591266|B4|Baseline|Total|Total of all reporting groups
570732|NCT00591266|B3|Baseline|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570733|NCT00591266|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570734|NCT00591266|B1|Baseline|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570735|NCT00591266|P3|Participant Flow|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570736|NCT00591266|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570737|NCT00591266|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570738|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570739|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570740|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570741|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570742|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570743|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570744|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570745|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570746|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570747|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570748|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570749|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570750|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570751|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570752|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570753|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570754|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570755|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570756|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570757|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570760|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570761|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570762|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570763|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570764|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570765|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570766|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570767|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570768|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570769|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570770|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570771|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570772|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570773|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570774|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570775|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570776|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570777|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570778|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570779|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570780|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570781|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570782|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570783|NCT00591266|E3|Reported Event|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570784|NCT00591266|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570785|NCT00591266|E1|Reported Event|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
570786|NCT00591253|B4|Baseline|Total|Total of all reporting groups
570787|NCT00591253|B3|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570788|NCT00591253|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570789|NCT00591253|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570790|NCT00591253|P3|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570791|NCT00591253|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570792|NCT00591253|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570793|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570794|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570795|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570796|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570797|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570798|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570799|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570800|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570801|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570802|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
571527|NCT00588731|E1|Reported Event|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
570804|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570805|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570806|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570807|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570808|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570809|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570810|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570811|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570812|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570813|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570814|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570815|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570816|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570817|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570818|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570819|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570820|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570821|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570822|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570823|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570824|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570825|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570826|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570827|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570828|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570829|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570830|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570831|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570832|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570833|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570834|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570835|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570836|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570837|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570838|NCT00591253|E3|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
570839|NCT00591253|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
570840|NCT00591253|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
570841|NCT00591240|B3|Baseline|Total|Total of all reporting groups
570842|NCT00591240|B2|Baseline|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570843|NCT00591240|B1|Baseline|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570844|NCT00591240|P2|Participant Flow|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570845|NCT00591240|P1|Participant Flow|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570846|NCT00591240|O2|Outcome|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570847|NCT00591240|O1|Outcome|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570848|NCT00591240|E2|Reported Event|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570849|NCT00591240|E1|Reported Event|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
570850|NCT00591227|B3|Baseline|Total|Total of all reporting groups
570851|NCT00591227|B2|Baseline|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
570852|NCT00591227|B1|Baseline|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
570853|NCT00591227|P2|Participant Flow|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
570854|NCT00591227|P1|Participant Flow|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
570855|NCT00591227|O2|Outcome|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
570856|NCT00591227|O1|Outcome|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
570857|NCT00591227|E2|Reported Event|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
570858|NCT00591227|E1|Reported Event|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
570859|NCT00591214|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570860|NCT00591214|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570861|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570862|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570863|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570864|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570865|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570866|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570867|NCT00591214|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
570868|NCT00591149|B1|Baseline|Oxalipatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles~Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
570949|NCT00590889|B2|Baseline|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
571008|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570869|NCT00591149|P1|Participant Flow|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks~Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
570870|NCT00591149|O1|Outcome|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles~Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
570871|NCT00591149|E1|Reported Event|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks~Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
570872|NCT00591019|B1|Baseline|All Participants|Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.
570873|NCT00591019|P2|Participant Flow|Baseline, Placebo, Modafinil 200 mg/Day|Subjects are tested after baseline, then after taking a sugar pill once per day in the morning for 14 days, and then after taking modafinil 200 mg/day for 14 days.
570874|NCT00591019|P1|Participant Flow|Baseline, Modafinil 200 mg/Day, Placebo|Subjects are tested at baseline, then after Modafinil (200mg/day, a.m. administration) for 14 days, then after placebo (for 14 days).
570875|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
570876|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
570877|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
570878|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
570879|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
570880|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
570881|NCT00591019|E3|Reported Event|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
570882|NCT00591019|E2|Reported Event|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
570883|NCT00591019|E1|Reported Event|Baseline Testing.|Establish baseline levels of performance
570884|NCT00591006|B1|Baseline|Total Study Population|Seventeen healthy controls, in a one-hour imaging session, received a structural MRI, MRS and fMRI scan four separate times with a 21 day washout between each study drug exposure in a crossover design. Prior to each scan each participant received placebo + placebo, phenytoin + placebo, hydrocortisone + placebo, or hydrocortisone + phenytoin in a random fashion. Thus, each participant received each of the four possible study drug combinations in a random order with an extended drug washout between each exposure. Hippocampal activation, volume and biochemistry, as well as mood and memory was assessed.
570885|NCT00591006|P24|Participant Flow|PH + PL Then PL + H Then PL + PL Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
570886|NCT00591006|P23|Participant Flow|PL + PL Then PH + H Then PL + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
570950|NCT00590889|B1|Baseline|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
570951|NCT00590889|P2|Participant Flow|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
570887|NCT00591006|P22|Participant Flow|PL + PL Then PL + H Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
570888|NCT00591006|P21|Participant Flow|PL + PL Then PL + H Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
570889|NCT00591006|P20|Participant Flow|PL + PL Then PH + H Then PH + PL Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
570890|NCT00591006|P19|Participant Flow|PL + PL Then PH + PL Then PL + H Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
570891|NCT00591006|P18|Participant Flow|PH + PL Then PH + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
570892|NCT00591006|P17|Participant Flow|PH + PL Then PH + H Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
570893|NCT00591006|P16|Participant Flow|PH + PL Then PL + PL Then PL + H Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
570952|NCT00590889|P1|Participant Flow|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
570953|NCT00590889|O2|Outcome|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
571528|NCT00588692|B3|Baseline|Total|Total of all reporting groups
570894|NCT00591006|P15|Participant Flow|PH + PL Then PL + PL Then PH + H Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
570895|NCT00591006|P14|Participant Flow|PH + H Then PL + PL Then PL + H Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
570896|NCT00591006|P13|Participant Flow|PH + H Then PL + PL Then PH + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
570897|NCT00591006|P12|Participant Flow|PH + H Then PH + PL Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
570898|NCT00591006|P11|Participant Flow|PH + H Then PL + H Then PH + PL Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
570899|NCT00591006|P10|Participant Flow|PH + H Then PL + H Then PL + PL Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
570900|NCT00591006|P9|Participant Flow|PL + H Then PH + PL Then PH + H Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
570954|NCT00590889|O1|Outcome|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
570955|NCT00590889|E2|Reported Event|Adverse Events for the Silzone™ Group|These patients received the Silzone™ treated heart valve.
570956|NCT00590889|E1|Reported Event|Adverse Events for the Conventional Group|These patients received a conventional heart valve.
570901|NCT00591006|P8|Participant Flow|PL + H Then PH + H Then PL + PL Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
570902|NCT00591006|P7|Participant Flow|PL + H Then PH +H Then PH + PL Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
570903|NCT00591006|P6|Participant Flow|PL + H Then PL + PL Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
570904|NCT00591006|P5|Participant Flow|PL + H Then PH + PL Then PL + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
570905|NCT00591006|P4|Participant Flow|PL + H Then PL + PL Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours (20mg) and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
570906|NCT00591006|P3|Participant Flow|PL + PL Then PH + PL Then PH + H Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
570907|NCT00591006|P2|Participant Flow|PH + H Then PH + PL Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
570957|NCT00590863|B4|Baseline|Total|Total of all reporting groups
570958|NCT00590863|B3|Baseline|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
571009|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570908|NCT00591006|P1|Participant Flow|PH + PL Then PL + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160 mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
570909|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570910|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570911|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570912|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570913|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570914|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570915|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets of placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570916|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
570917|NCT00591006|O4|Outcome|Placebo&Hydrocortisone|Examining all participants for the condition in which they took placebo and hydrocortisone.
570918|NCT00591006|O3|Outcome|Phenytoin&Placebo|Examining all participants for the condition in which they took phenytoin and placebo.
570919|NCT00591006|O2|Outcome|Placebo&Placebo|Examining all participants for the condition in which they took placebo for both administrations.
570920|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Examining all participants for the condition in which they took both phenytoin and hydrocortisone.
570921|NCT00591006|E4|Reported Event|Placebo, Then Placebo|"Hydrocortisone, Phenytoin~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
570922|NCT00591006|E3|Reported Event|Placebo, Then Hydrocortisone|"Hydrocortisone, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
570923|NCT00591006|E2|Reported Event|Phenytoin, Then Placebo|"Phenytoin, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
570924|NCT00591006|E1|Reported Event|Phenytoin, Then Hydrocortisone|"Placebo, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
570925|NCT00590980|B1|Baseline|Study Participants|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
570926|NCT00590980|P1|Participant Flow|All Study Participants|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
570927|NCT00590980|O1|Outcome|Study Participants|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
570928|NCT00590980|E1|Reported Event|Observation|Patients with intracranial or extracranial vertebrobasilar occlusion or stenosis ≥ 50% presenting with vertebrobasilar distribution TIA or stroke.
570929|NCT00590967|B3|Baseline|Total|Total of all reporting groups
570930|NCT00590967|B2|Baseline|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570931|NCT00590967|B1|Baseline|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin 40 mg/m^2"
570932|NCT00590967|P2|Participant Flow|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570933|NCT00590967|P1|Participant Flow|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).~Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)~Weekly cisplatin 40 mg/m^2"
570934|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570935|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570936|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570937|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570938|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570939|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570940|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570941|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570942|NCT00590967|E2|Reported Event|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570943|NCT00590967|E1|Reported Event|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
570944|NCT00590902|B1|Baseline|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
570945|NCT00590902|P1|Participant Flow|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
570946|NCT00590902|O1|Outcome|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
570947|NCT00590902|E1|Reported Event|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
570948|NCT00590889|B3|Baseline|Total|Total of all reporting groups
570959|NCT00590863|B2|Baseline|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
570960|NCT00590863|B1|Baseline|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
570961|NCT00590863|P3|Participant Flow|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
570962|NCT00590863|P2|Participant Flow|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
570963|NCT00590863|P1|Participant Flow|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
570964|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.~Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
570965|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venalfaxine XR + Mirtazapine for up to 28 weeks.
570966|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
570967|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.~Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
570968|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venlafaine XR + Mirtazapine for up to 28 weeks.
570969|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
570970|NCT00590863|E3|Reported Event|Escitalopram + Placebo|Participants will take Escitalopram + Placebo for up to 28 weeks.
570971|NCT00590863|E2|Reported Event|Venlafaxine XR + Mirtazapine|Participants will take Venlafaxine XR + Mirtazapine for up to 28 weeks.
570972|NCT00590863|E1|Reported Event|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
570973|NCT00590772|B1|Baseline|Group 1|cross over
570974|NCT00590772|P1|Participant Flow|Group 1|subjects were randomized to placebo or active drug and then cross over to opposite; however, the details of the randomization are no longer available.
570975|NCT00590772|O2|Outcome|Placebo|
570976|NCT00590772|O1|Outcome|Montelukast|
570977|NCT00590772|E2|Reported Event|Placebo|
570978|NCT00590772|E1|Reported Event|Montelukast|
570979|NCT00590759|B1|Baseline|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
570980|NCT00590759|P1|Participant Flow|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
570981|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
570982|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
570983|NCT00590759|E1|Reported Event|0502 TAG Device Subjects|
570984|NCT00590720|B3|Baseline|Total|Total of all reporting groups
570985|NCT00590720|B2|Baseline|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570986|NCT00590720|B1|Baseline|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570987|NCT00590720|P2|Participant Flow|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570988|NCT00590720|P1|Participant Flow|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570989|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570990|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570991|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570992|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570993|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570994|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570995|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570996|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570997|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
570998|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
570999|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571000|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571001|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571002|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571003|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571004|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571005|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571006|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571007|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
575749|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
571010|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571011|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571012|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571013|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571014|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571015|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571016|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571017|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571018|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571019|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571020|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571021|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571022|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571023|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571024|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571025|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
571026|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
571027|NCT00590720|E2|Reported Event|MEDI528 50 mg|
571028|NCT00590720|E1|Reported Event|PLACEBO|
571029|NCT00590590|B4|Baseline|Total|Total of all reporting groups
571030|NCT00590590|B3|Baseline|Placebo|Placebo administered twice weekly for 4 months
571031|NCT00590590|B2|Baseline|Lidocaine|Lidocaine administered twice weekly for 4 months
571032|NCT00590590|B1|Baseline|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571033|NCT00590590|P3|Participant Flow|Placebo|Placebo administered twice weekly for 4 months
571034|NCT00590590|P2|Participant Flow|Lidocaine|Lidocaine administered twice weekly for 4 months
571035|NCT00590590|P1|Participant Flow|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571036|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
571037|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
571038|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571039|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
571040|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
571041|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571042|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
571043|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
571044|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571045|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
571046|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
571047|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571048|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
571049|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
571050|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571051|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
571052|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
571053|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571054|NCT00590590|E3|Reported Event|Placebo|Placebo administered twice weekly for 4 months
571055|NCT00590590|E2|Reported Event|Lidocaine|Lidocaine administered twice weekly for 4 months
571056|NCT00590590|E1|Reported Event|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
571057|NCT00590577|B5|Baseline|Total|Total of all reporting groups
571058|NCT00590577|B4|Baseline|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571059|NCT00590577|B3|Baseline|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571060|NCT00590577|B2|Baseline|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571061|NCT00590577|B1|Baseline|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571062|NCT00590577|P4|Participant Flow|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571147|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
571063|NCT00590577|P3|Participant Flow|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571064|NCT00590577|P2|Participant Flow|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571065|NCT00590577|P1|Participant Flow|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571066|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571067|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571068|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571069|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571070|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571071|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571072|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571073|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571074|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571075|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571076|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571077|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571078|NCT00590577|E4|Reported Event|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571079|NCT00590577|E3|Reported Event|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
571080|NCT00590577|E2|Reported Event|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571081|NCT00590577|E1|Reported Event|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
571082|NCT00590564|B1|Baseline|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
571083|NCT00590564|P1|Participant Flow|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
571084|NCT00590564|O1|Outcome|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
571085|NCT00590564|E1|Reported Event|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
571086|NCT00590538|B1|Baseline|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571087|NCT00590538|P1|Participant Flow|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571088|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571089|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571148|NCT00590226|E2|Reported Event|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
575750|NCT00577135|O4|Outcome|High Intensification|
571090|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571091|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571092|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571093|NCT00590538|E1|Reported Event|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
571094|NCT00590460|B1|Baseline|Group1|only one group
571095|NCT00590460|P1|Participant Flow|Allo Stem Cell Transplant|Allogeneic Stem Cell Transplant
571096|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single Group: Allogeneic Stem Cell Transplant
571097|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
571098|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single Group: Allogeneic Stem Cell Transplant
571099|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single group: Allogeneic Stem Cell Transplant
571100|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single Group: Allogeneic Stem Cell Transplant
571101|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single Group: Allogeneic Stem Cell Transplant
571102|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single Group: Allogeneic Stem Cell Transplant
571103|NCT00590460|O1|Outcome|Allo Stem Cell Transplant|Allogeneic Stem Cell Transplant
571104|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single Group - Allogeneic Stem Cell Transplant
571105|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|Single Group: Allogeneic Stem Cell Transplant
571106|NCT00590460|E1|Reported Event|Group1|only one group
571107|NCT00590369|B3|Baseline|Total|Total of all reporting groups
571108|NCT00590369|B2|Baseline|Versatile One|Versatile One (EZCare)negative wound therapy device
571109|NCT00590369|B1|Baseline|KCI VAC|KCI VAC type negative pressure wound therapy device
571110|NCT00590369|P2|Participant Flow|Versatile One|Versatile One (EZCare)negative wound therapy device
571111|NCT00590369|P1|Participant Flow|KCI VAC|KCI VAC type negative pressure wound therapy device
571112|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
571113|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
571114|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
571115|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
571116|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
571117|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
571118|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
571119|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
571120|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
571121|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
571122|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
571123|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
571124|NCT00590369|E2|Reported Event|Versatile One|Versatile One (EZCare)negative wound therapy device
571125|NCT00590369|E1|Reported Event|KCI VAC|KCI VAC type negative pressure wound therapy device
571126|NCT00590317|B3|Baseline|Total|Total of all reporting groups
571127|NCT00590317|B2|Baseline|Ondansetron|Patients receiving Ondansetron 4 mg IV
571128|NCT00590317|B1|Baseline|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
571129|NCT00590317|P2|Participant Flow|Ondansetron|Patients receiving Ondansetron 4mg IV
571130|NCT00590317|P1|Participant Flow|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
571131|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
571132|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
571133|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
571134|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
571135|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
571136|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
571137|NCT00590317|E2|Reported Event|Ondansetron|Patients receiving Ondansetron 4mg IV
571138|NCT00590317|E1|Reported Event|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
571139|NCT00590226|B3|Baseline|Total|Total of all reporting groups
571140|NCT00590226|B2|Baseline|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
571141|NCT00590226|B1|Baseline|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
571142|NCT00590226|P2|Participant Flow|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
571143|NCT00590226|P1|Participant Flow|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
571144|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
571145|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
571146|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
571149|NCT00590226|E1|Reported Event|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
571150|NCT00590161|B3|Baseline|Total|Total of all reporting groups
571151|NCT00590161|B2|Baseline|Placebo TID|29 subjects received placebo as above for one year
571152|NCT00590161|B1|Baseline|Pentoxifylline (PTX) 400 mg PO (by Mouth) TID|26 subjects received PTX at dose above for one year
571153|NCT00590161|P2|Participant Flow|Placebo TID|29 subjects received placebo as above for one year
571154|NCT00590161|P1|Participant Flow|Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID)|26 subjects received PTX at dose above for one year
571155|NCT00590161|O2|Outcome|Placebo Tid|29 subjects received placebo as above for one year
571156|NCT00590161|O1|Outcome|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
571157|NCT00590161|E2|Reported Event|Placebo Tid|29 subjects received placebo as above for one year
571158|NCT00590161|E1|Reported Event|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
571159|NCT00590135|B1|Baseline|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571160|NCT00590135|P1|Participant Flow|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571161|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571162|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571163|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571164|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571165|NCT00590135|O1|Outcome|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571166|NCT00590135|E1|Reported Event|AORTIC STENOSIS PATIENTS|"Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily~atorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily"
571167|NCT00590044|B3|Baseline|Total|Total of all reporting groups
571168|NCT00590044|B2|Baseline|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
571169|NCT00590044|B1|Baseline|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
571170|NCT00590044|P2|Participant Flow|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
571171|NCT00590044|P1|Participant Flow|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
571172|NCT00590044|O2|Outcome|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
571173|NCT00590044|O1|Outcome|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
571174|NCT00590044|E2|Reported Event|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
571175|NCT00590044|E1|Reported Event|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
571176|NCT00590031|B1|Baseline|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
571177|NCT00590031|P1|Participant Flow|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
571178|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
571179|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
571212|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
571266|NCT00589888|E5|Reported Event|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
571529|NCT00588692|B2|Baseline|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571180|NCT00590031|E1|Reported Event|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
571181|NCT00590018|B3|Baseline|Total|Total of all reporting groups
571182|NCT00590018|B2|Baseline|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
571183|NCT00590018|B1|Baseline|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
571184|NCT00590018|P2|Participant Flow|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
571185|NCT00590018|P1|Participant Flow|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
571186|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
571187|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
571188|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
571189|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
571190|NCT00590018|E2|Reported Event|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
571191|NCT00590018|E1|Reported Event|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
571192|NCT00590005|B1|Baseline|Children With Asthma|The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe)
571193|NCT00590005|P2|Participant Flow|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
571194|NCT00590005|P1|Participant Flow|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
571195|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
571196|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
571197|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
571198|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
571199|NCT00590005|E2|Reported Event|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
571200|NCT00590005|E1|Reported Event|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
571201|NCT00589979|B3|Baseline|Total|Total of all reporting groups
571202|NCT00589979|B2|Baseline|Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
571203|NCT00589979|B1|Baseline|Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
571204|NCT00589979|P3|Participant Flow|Treatment Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571205|NCT00589979|P2|Participant Flow|Treatment Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571206|NCT00589979|P1|Participant Flow|Run-in Period: Lidoderm|Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks).
571207|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
571208|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
571209|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571210|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571211|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
571213|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571214|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571215|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571216|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571217|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
571218|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
571219|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571220|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571221|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
571222|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
571223|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571224|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571225|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571226|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571227|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
571228|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
571229|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
571230|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
571231|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving Placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
571232|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
571233|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571234|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571235|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571236|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (Lidocaine 5% Patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571237|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571659|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571238|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
571239|NCT00589979|E3|Reported Event|Double-Blind Active Treatment Period With Placebo|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Placebo during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~**NOTE: two subjects randomized to the treatment sequence Lidoderm - Placebo - Placebo (PLL) discontinued from the study during treatment with Lidoderm (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Placebo) is equal to 91."
571240|NCT00589979|E2|Reported Event|Double-Blind Treatment Period With Lidoderm|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~*NOTE: two subjects randomized to the treatment sequence Placebo - Lidoderm - Lidoderm (PLL) discontinued from the study during treatment with Placebo (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Lidoderm) is equal to 91."
571241|NCT00589979|E1|Reported Event|Run-In Period With Lidoderm (Lidocaine 5% Patch)|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the active treatment Run-in Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated)."
571242|NCT00589914|B3|Baseline|Total|Total of all reporting groups
571243|NCT00589914|B2|Baseline|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
571244|NCT00589914|B1|Baseline|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
571245|NCT00589914|P2|Participant Flow|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
571246|NCT00589914|P1|Participant Flow|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
571247|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
571248|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
571249|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
571250|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
571251|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
571252|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
571253|NCT00589914|E2|Reported Event|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
571254|NCT00589914|E1|Reported Event|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
571255|NCT00589888|B1|Baseline|All Study Participants|"All participants received all 5 arms in random order:~0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours~Intralipid 20% @ 20cc/hr for 8 hours~Intralipid 20% @ 40cc/Hr for 8 hours~32-gram Oral Fat Load every 2 hours for 8 hours.~64-gram Oral Fat Loadevery 2 hours for 8 hours."
571256|NCT00589888|P5|Participant Flow|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
571257|NCT00589888|P4|Participant Flow|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
571258|NCT00589888|P3|Participant Flow|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
571259|NCT00589888|P2|Participant Flow|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
571260|NCT00589888|P1|Participant Flow|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
571261|NCT00589888|O1|Outcome|Oral 64-gram Fat Load|For the high (64 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
571262|NCT00589888|O1|Outcome|Oral 32-gram Fat Load|For the low (32 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
571263|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
571264|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
571265|NCT00589888|O1|Outcome|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
571267|NCT00589888|E4|Reported Event|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
571268|NCT00589888|E3|Reported Event|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
571269|NCT00589888|E2|Reported Event|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
571270|NCT00589888|E1|Reported Event|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
571271|NCT00589849|B1|Baseline|T Wave Altenans Stress Test|
571272|NCT00589849|P1|Participant Flow|T Wave Altenans Stress Test|
571273|NCT00589849|O1|Outcome|T Wave Altenans Stress Test|
571274|NCT00589849|E1|Reported Event|T Wave Altenans Stress Test|
571275|NCT00589836|B1|Baseline|Cardiac Pathologies|Patients with cardiac pathologies of aortic root disorder, severe aortic stenosis, severe aortic insufficiency, aortic valve replacement, ischemic heart disease and cardiomyopathies had tissue DTI and MRI performed
571276|NCT00589836|P1|Participant Flow|Cardiac Pathologies|Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
571277|NCT00589836|O1|Outcome|Cardiac Pathologies|Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
571278|NCT00589836|E1|Reported Event|Cardiac Pathologies|Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
571279|NCT00589784|B3|Baseline|Total|Total of all reporting groups
571280|NCT00589784|B2|Baseline|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
571281|NCT00589784|B1|Baseline|Aggressive Memingioma|Patients with Aggressive Memingioma
571282|NCT00589784|P2|Participant Flow|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
571283|NCT00589784|P1|Participant Flow|Aggressive Memingioma|Patients with Aggressive Memingioma
571284|NCT00589784|O2|Outcome|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
571285|NCT00589784|O1|Outcome|Aggressive Memingioma|Patients with Aggressive Memingioma
571286|NCT00589784|E1|Reported Event|All Patients|All patients treated with Sunitinib (SU011248)
571287|NCT00589693|B3|Baseline|Total|Total of all reporting groups
571288|NCT00589693|B2|Baseline|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571289|NCT00589693|B1|Baseline|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571290|NCT00589693|P2|Participant Flow|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571291|NCT00589693|P1|Participant Flow|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571292|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571293|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571294|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571295|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571296|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571297|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571298|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571299|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571300|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571301|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571302|NCT00589693|E2|Reported Event|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
571303|NCT00589693|E1|Reported Event|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
571304|NCT00589667|B1|Baseline|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
571305|NCT00589667|P1|Participant Flow|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
571306|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
571307|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
571308|NCT00589667|E1|Reported Event|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
571309|NCT00589628|B3|Baseline|Total|Total of all reporting groups
571310|NCT00589628|B2|Baseline|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
571311|NCT00589628|B1|Baseline|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
571312|NCT00589628|P2|Participant Flow|Infliximab 10 mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
571313|NCT00589628|P1|Participant Flow|Infliximab 5 mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
571314|NCT00589628|O2|Outcome|Infliximab 10mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
571315|NCT00589628|O1|Outcome|Infliximab 5mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
571316|NCT00589628|E2|Reported Event|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
571317|NCT00589628|E1|Reported Event|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
571318|NCT00589602|B1|Baseline|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
571319|NCT00589602|P1|Participant Flow|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
571320|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.~cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4~tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
571321|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.~cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4~tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
571322|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.~cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4~tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
571323|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of matched unrelated donor allogeneic bone marrow transplant (MUD allo BMT) and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; allogeneic hematopoietic stem cell transplantation;~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
571324|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
571325|NCT00589602|E1|Reported Event|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
571326|NCT00589563|B1|Baseline|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571327|NCT00589563|P1|Participant Flow|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571328|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571329|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571330|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571331|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571332|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571333|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571334|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571335|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571336|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
575751|NCT00577135|O3|Outcome|Low Intensification|
571337|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571338|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571339|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571340|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571341|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
571342|NCT00589563|E1|Reported Event|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
571343|NCT00589550|B1|Baseline|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571344|NCT00589550|P1|Participant Flow|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571345|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571346|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571347|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571348|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571349|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571350|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571351|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571397|NCT00589121|P1|Participant Flow|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
575752|NCT00577135|O2|Outcome|Continuous Infusion|
571352|NCT00589550|E1|Reported Event|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
571353|NCT00589472|B1|Baseline|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571354|NCT00589472|P1|Participant Flow|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571355|NCT00589472|O1|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571356|NCT00589472|O1|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571357|NCT00589472|O1|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571358|NCT00589472|O1|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571359|NCT00589472|O1|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571360|NCT00589472|O1|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571398|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571399|NCT00589121|O2|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
572163|NCT00586625|O2|Outcome|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
571361|NCT00589472|O1|Outcome|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571362|NCT00589472|E1|Reported Event|Treatment (Antihormone Therapy and Enzyme Inhibitor Therapy)|"Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Therapeutic Conventional Surgery: Undergo radical prostatectomy~Vorinostat: Given PO"
571363|NCT00589303|B3|Baseline|Total|Total of all reporting groups
571364|NCT00589303|B2|Baseline|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
571365|NCT00589303|B1|Baseline|Drug Therapy|FDA approved rate and rhythm control drugs
571366|NCT00589303|P2|Participant Flow|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
571367|NCT00589303|P1|Participant Flow|Drug Therapy|FDA approved rate and rhythm control drugs
571368|NCT00589303|O2|Outcome|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
571369|NCT00589303|O1|Outcome|Drug Therapy|FDA approved rate and rhythm control drugs
571370|NCT00589303|E2|Reported Event|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
571371|NCT00589303|E1|Reported Event|Drug Therapy|FDA approved rate and rhythm control drugs
571372|NCT00589290|B1|Baseline|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
571373|NCT00589290|P1|Participant Flow|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
571374|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
571375|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
571376|NCT00589290|O1|Outcome|Belinostat|1000 mg/m^2 day, 30 minute intravenous infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
571377|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
571378|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
571379|NCT00589290|E1|Reported Event|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
571380|NCT00589277|B3|Baseline|Total|Total of all reporting groups
571381|NCT00589277|B2|Baseline|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
571382|NCT00589277|B1|Baseline|Standard Care Counseling|Standard care counseling + standard care print information
571383|NCT00589277|P2|Participant Flow|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
571384|NCT00589277|P1|Participant Flow|Standard Care Counseling|Standard care counseling + standard care print information
571385|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
571386|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
571387|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
571388|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
571389|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
571390|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
571391|NCT00589277|E2|Reported Event|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
571392|NCT00589277|E1|Reported Event|Standard Care Counseling|Standard care counseling + standard care print information
571393|NCT00589121|B3|Baseline|Total|Total of all reporting groups
571394|NCT00589121|B2|Baseline|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571395|NCT00589121|B1|Baseline|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571396|NCT00589121|P2|Participant Flow|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571400|NCT00589121|O1|Outcome|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571401|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571402|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571403|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571404|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571405|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571406|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571407|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571408|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571409|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571410|NCT00589121|O1|Outcome|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571411|NCT00589121|E2|Reported Event|Cohort B - No Chemotherapy|Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571412|NCT00589121|E1|Reported Event|Cohort A - Chemotherapy|Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
571413|NCT00589108|B4|Baseline|Total|Total of all reporting groups
571414|NCT00589108|B3|Baseline|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571415|NCT00589108|B2|Baseline|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571416|NCT00589108|B1|Baseline|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571417|NCT00589108|P3|Participant Flow|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571418|NCT00589108|P2|Participant Flow|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571419|NCT00589108|P1|Participant Flow|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571420|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571421|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571422|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571423|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571424|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571425|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571426|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571427|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571428|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571429|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571430|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571431|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571432|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571433|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571434|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571435|NCT00589108|E3|Reported Event|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
571436|NCT00589108|E2|Reported Event|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
571437|NCT00589108|E1|Reported Event|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
571438|NCT00588965|B1|Baseline|All Subjects|Subjects will take propranolol LA 80 mg or placebo daily for one week then propranolol LA 160 mg for one week or 2 placebo pills, followed by the exercise test. The participants will be randomized to one of 2 sequences: placebo first or propranolol first.
571439|NCT00588965|P1|Participant Flow|All Participants|All participants were randomized to one of 2 sequences, in which they received either propranolol first, then placebo, or placebo first, then propranolol.
571440|NCT00588965|O2|Outcome|Propranolol|
571441|NCT00588965|O1|Outcome|Placebo|
571442|NCT00588965|O2|Outcome|Propranolol|
571443|NCT00588965|O1|Outcome|Placebo|
571444|NCT00588965|E2|Reported Event|Propranolol|Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.
571445|NCT00588965|E1|Reported Event|Placebo|Subjects are assigned to placebo.
571446|NCT00588952|B3|Baseline|Total|Total of all reporting groups
571447|NCT00588952|B2|Baseline|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
571448|NCT00588952|B1|Baseline|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
571449|NCT00588952|P2|Participant Flow|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
571450|NCT00588952|P1|Participant Flow|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
571451|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571452|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571453|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571454|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571455|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571456|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571457|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571458|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571459|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571460|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571461|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571462|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571463|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571464|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571465|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571466|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571467|NCT00588952|E2|Reported Event|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571468|NCT00588952|E1|Reported Event|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
571469|NCT00588900|B1|Baseline|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
571470|NCT00588900|P1|Participant Flow|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
571471|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
571472|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
571473|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
571474|NCT00588900|E1|Reported Event|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
571475|NCT00588861|B3|Baseline|Total|Total of all reporting groups
571476|NCT00588861|B2|Baseline|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
571477|NCT00588861|B1|Baseline|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
571478|NCT00588861|P2|Participant Flow|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
571479|NCT00588861|P1|Participant Flow|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
571480|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
571481|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
571482|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
571483|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
571484|NCT00588861|E2|Reported Event|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
571485|NCT00588861|E1|Reported Event|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
571486|NCT00588848|B3|Baseline|Total|Total of all reporting groups
571487|NCT00588848|B2|Baseline|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
571488|NCT00588848|B1|Baseline|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
571489|NCT00588848|P2|Participant Flow|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
571490|NCT00588848|P1|Participant Flow|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
571491|NCT00588848|O2|Outcome|CPAP Arm (Usual Care)|"The intervention will be the use of the subject's own CPAP machine and this will be applied to the subject during the 8 hours overnight the first after surgery (study night). During the study night, they will undergo full polysomnography in their hospital room.~CPAP: Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)"
571492|NCT00588848|O1|Outcome|Autoadjusting CPAP (VPAP Auto)|"The intervention will be the use of an Autoadjusting CPAP unit that will be applied to the subject during the 8 hours overnight the first night after surgery (study night). During this time, they will undergo a full night attended polysomnogram in their hospital room.~Autoadjusting CPAP (VPAP Auto): An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery)."
571493|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
571494|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
571495|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
571496|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
571525|NCT00588731|O1|Outcome|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
571526|NCT00588731|E2|Reported Event|Placebo|Placebo: Placebo
571497|NCT00588848|E2|Reported Event|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
571498|NCT00588848|E1|Reported Event|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
571499|NCT00588822|B1|Baseline|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571500|NCT00588822|P1|Participant Flow|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571501|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571502|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571503|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571504|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571505|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571506|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571507|NCT00588822|E1|Reported Event|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
571508|NCT00588809|B1|Baseline|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571509|NCT00588809|P1|Participant Flow|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571510|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571511|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571512|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571513|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571514|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571515|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571516|NCT00588809|E1|Reported Event|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
571517|NCT00588731|B3|Baseline|Total|Total of all reporting groups
571518|NCT00588731|B2|Baseline|Placebo|Placebo: Placebo
571519|NCT00588731|B1|Baseline|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
571520|NCT00588731|P2|Participant Flow|Placebo|Placebo: Placebo
571521|NCT00588731|P1|Participant Flow|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
571522|NCT00588731|O2|Outcome|Placebo|Placebo: Placebo
571523|NCT00588731|O1|Outcome|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
571524|NCT00588731|O2|Outcome|Placebo|Placebo: Placebo
571530|NCT00588692|B1|Baseline|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571531|NCT00588692|P2|Participant Flow|SphygmoCor Blinded|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
571532|NCT00588692|P1|Participant Flow|SphygmoCor Unblinded|"The use of the sphygmocor values will determine medication adjustments to optimize heart failure (HF) treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
571533|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571534|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571535|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571536|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571537|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571538|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571539|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571540|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571541|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571542|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571543|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571544|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571545|NCT00588692|O2|Outcome|Control|Sphygmocor values will be blinded to the investigator.
571546|NCT00588692|O1|Outcome|Treatment|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571547|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571548|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571549|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571550|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571551|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571552|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571553|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571554|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571555|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571556|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571557|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571558|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571559|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571560|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571561|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571562|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571563|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
571564|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
571565|NCT00588692|E2|Reported Event|Control|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
571566|NCT00588692|E1|Reported Event|Treatment|"The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
571567|NCT00588666|B1|Baseline|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
571590|NCT00588471|E1|Reported Event|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
571658|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571568|NCT00588666|P1|Participant Flow|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
571569|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
571570|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
571571|NCT00588666|E1|Reported Event|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
571572|NCT00588640|B1|Baseline|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
571573|NCT00588640|P1|Participant Flow|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
571574|NCT00588640|O1|Outcome|Phase I, Cohort l|"oral d-methadone 40 mg~d-Methadone: 8 subjects to receive 40 mg d-Methadone twice a day"
571575|NCT00588640|E1|Reported Event|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
571576|NCT00588536|B1|Baseline|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
571577|NCT00588536|P1|Participant Flow|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
571578|NCT00588536|O1|Outcome|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
571579|NCT00588536|E1|Reported Event|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
571580|NCT00588471|B3|Baseline|Total|Total of all reporting groups
571581|NCT00588471|B2|Baseline|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
571582|NCT00588471|B1|Baseline|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
571583|NCT00588471|P2|Participant Flow|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
571584|NCT00588471|P1|Participant Flow|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
571585|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
571586|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
571587|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
571588|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
571589|NCT00588471|E2|Reported Event|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
571591|NCT00588445|B1|Baseline|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
571592|NCT00588445|P1|Participant Flow|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
571593|NCT00588445|O2|Outcome|EGFR Mutation Negative|Tumor specimens analyzed for EGFR mutation
571594|NCT00588445|O1|Outcome|EGFR Mutation Positive|Tumor specimens analyzed for EGFR mutation
571595|NCT00588445|O1|Outcome|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
571596|NCT00588445|E1|Reported Event|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
571597|NCT00588406|B3|Baseline|Total|Total of all reporting groups
571598|NCT00588406|B2|Baseline|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571599|NCT00588406|B1|Baseline|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571600|NCT00588406|P2|Participant Flow|Placob|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571601|NCT00588406|P1|Participant Flow|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571602|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571603|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571604|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571605|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571606|NCT00588406|E2|Reported Event|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571607|NCT00588406|E1|Reported Event|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
571608|NCT00588380|B1|Baseline|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
571609|NCT00588380|P1|Participant Flow|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
571610|NCT00588380|O1|Outcome|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
571611|NCT00588380|O1|Outcome|All Participants|C-peptide as a marker of insulin secretion
571612|NCT00588380|E1|Reported Event|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
571614|NCT00588354|B2|Baseline|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
571615|NCT00588354|B1|Baseline|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
571616|NCT00588354|P2|Participant Flow|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
571617|NCT00588354|P1|Participant Flow|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
571618|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571619|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571620|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571621|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571622|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571623|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571624|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571625|NCT00588354|O1|Outcome|2% Lidocaine and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571626|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571627|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571628|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571629|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571630|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571631|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571632|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
571633|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
571634|NCT00588354|E2|Reported Event|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
571635|NCT00588354|E1|Reported Event|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
571636|NCT00588341|B1|Baseline|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
571637|NCT00588341|P1|Participant Flow|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
571638|NCT00588341|O1|Outcome|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
571639|NCT00588341|E1|Reported Event|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
571640|NCT00588237|B1|Baseline|All Patients|Paclitaxel, Cisplatin, Bevacizumab
571641|NCT00588237|P1|Participant Flow|All Patients|Paclitaxel, Cisplatin, Bevacizumab
571642|NCT00588237|O1|Outcome|All Patients|Paclitaxel, Cisplatin, Bevacizumab
571643|NCT00588237|E1|Reported Event|All Patients|Paclitaxel, Cisplatin, Bevacizumab
571644|NCT00588159|B3|Baseline|Total|Total of all reporting groups
571645|NCT00588159|B2|Baseline|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571646|NCT00588159|B1|Baseline|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571647|NCT00588159|P2|Participant Flow|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571648|NCT00588159|P1|Participant Flow|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571649|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571650|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571651|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571652|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571653|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571654|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571655|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571656|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571657|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571660|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571661|NCT00588159|E2|Reported Event|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
571662|NCT00588159|E1|Reported Event|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
571663|NCT00588146|B1|Baseline|Entire Study Population|Includes groups randomized to pegylated interferon alpha-2b first and standard care first.
571664|NCT00588146|P2|Participant Flow|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
571665|NCT00588146|P1|Participant Flow|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
571666|NCT00588146|O2|Outcome|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
571667|NCT00588146|O1|Outcome|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
571668|NCT00588146|E2|Reported Event|Standard Care|Subjects received standard care for hereditary hemorrhagic telangiectasia.
571669|NCT00588146|E1|Reported Event|Pegylated Interferon Alpha-2b|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week
571670|NCT00588094|B1|Baseline|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
571671|NCT00588094|P1|Participant Flow|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
571672|NCT00588094|O1|Outcome|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
571673|NCT00588094|E1|Reported Event|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
571674|NCT00587990|B4|Baseline|Total|Total of all reporting groups
571675|NCT00587990|B3|Baseline|(3) Placebo|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
571676|NCT00587990|B2|Baseline|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
571677|NCT00587990|B1|Baseline|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
571678|NCT00587990|P3|Participant Flow|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
571679|NCT00587990|P2|Participant Flow|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
571680|NCT00587990|P1|Participant Flow|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
571681|NCT00587990|O3|Outcome|(3) Placebo|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
571682|NCT00587990|O2|Outcome|Higher Dose MSC Injection|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 10^8 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 10^8 cells. The injections will be administered following completion of CABG surgery."
571724|NCT00587847|E1|Reported Event|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
571725|NCT00587834|B1|Baseline|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
571683|NCT00587990|O1|Outcome|Lower Dose Mesenchymal Stem Cell (MSC) Injection|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 10^7 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 10^7 cells. The injections will be administered following completion of CABG surgery."
571684|NCT00587990|O3|Outcome|(3) Placebo|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
571685|NCT00587990|O2|Outcome|Higher Dose MSC Injection|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 10^8 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 10^8 cells. The injections will be administered following completion of CABG surgery."
571686|NCT00587990|O1|Outcome|Lower Dose Mesenchymal Stem Cell (MSC) Injection|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 10^7 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 10^7 cells. The injections will be administered following completion of CABG surgery."
571687|NCT00587990|O3|Outcome|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
571688|NCT00587990|O2|Outcome|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
571689|NCT00587990|O1|Outcome|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
571690|NCT00587990|E3|Reported Event|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
571691|NCT00587990|E2|Reported Event|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
571692|NCT00587990|E1|Reported Event|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
571693|NCT00587964|B1|Baseline|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
571694|NCT00587964|P1|Participant Flow|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
571695|NCT00587964|O1|Outcome|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
571696|NCT00587964|E1|Reported Event|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
571697|NCT00587860|B3|Baseline|Total|Total of all reporting groups
571698|NCT00587860|B2|Baseline|Placebo|Placebo, twice a day
571699|NCT00587860|B1|Baseline|St. John's Wort|St. John's Wort, 450 mg twice a day
571700|NCT00587860|P2|Participant Flow|Placebo|Placebo, twice a day
571701|NCT00587860|P1|Participant Flow|St. John's Wort|St. John's Wort, 450 mg twice a day
571702|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571703|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571704|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571705|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571706|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571707|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571708|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571709|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571710|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571711|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571712|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571713|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571714|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571715|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571716|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
571717|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
571718|NCT00587860|E2|Reported Event|Placebo|Placebo, twice a day
571719|NCT00587860|E1|Reported Event|St. John's Wort|St. John's Wort, 450 mg twice a day
571720|NCT00587847|B1|Baseline|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
571721|NCT00587847|P1|Participant Flow|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
571722|NCT00587847|O1|Outcome|All Participants|All participants were included in the safety analysis.
571723|NCT00587847|O1|Outcome|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
575753|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
571726|NCT00587834|P1|Participant Flow|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
571727|NCT00587834|O2|Outcome|Gintuit Sensitive|Included ratings of Moderate and Severe
571728|NCT00587834|O1|Outcome|Gintuit Not Sensitive|Included ratings of None and Mild
571729|NCT00587834|O1|Outcome|Gintuit|Single application of Gintuit and FGG (control); split-mouth design. Number of subjects preferring Gintuit over Control.
571730|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
571731|NCT00587834|O2|Outcome|Gintuit Not Equally Firm as Adjacent Tissue|"Not Equally Firm includes responses of less firm and more firm"
571732|NCT00587834|O1|Outcome|Gintuit Equally Firm as Adjacent Tissue|
571733|NCT00587834|O2|Outcome|Gintuit Not Equally Red as Adjacent Tissue|"Not Equally Red includes responses of more red and less red"
571734|NCT00587834|O1|Outcome|Gintuit Equally Red as Adjacent Tissue|
571735|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
571736|NCT00587834|E5|Reported Event|Other|Adverse events occurring at any other location in the body or systemic conditions
571737|NCT00587834|E4|Reported Event|Mouth|Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites.
571738|NCT00587834|E3|Reported Event|Palatal Donation Site|Adverse events occurring at the palatal donation site
571739|NCT00587834|E2|Reported Event|Free Gingival Graft|Adverse events occurring at the autologous free gingival graft site
571740|NCT00587834|E1|Reported Event|Gintuit|Adverse events occurring at the Gintuit treated site
571741|NCT00587795|B3|Baseline|Total|Total of all reporting groups
571742|NCT00587795|B2|Baseline|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
571743|NCT00587795|B1|Baseline|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
571744|NCT00587795|P2|Participant Flow|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
571745|NCT00587795|P1|Participant Flow|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
571746|NCT00587795|O2|Outcome|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
571747|NCT00587795|O1|Outcome|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
571748|NCT00587795|E2|Reported Event|Control|"Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.~Placement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months."
571749|NCT00587795|E1|Reported Event|StabilAir Wrist Brace|"One study group will consist of patients treated with the StabilAir Wrist Brace.~StabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months."
571750|NCT00587769|B1|Baseline|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
571751|NCT00587769|P1|Participant Flow|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
571752|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
571753|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
571754|NCT00587769|E1|Reported Event|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
571755|NCT00587678|B4|Baseline|Total|Total of all reporting groups
571756|NCT00587678|B3|Baseline|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571757|NCT00587678|B2|Baseline|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571758|NCT00587678|B1|Baseline|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571759|NCT00587678|P3|Participant Flow|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571760|NCT00587678|P2|Participant Flow|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571761|NCT00587678|P1|Participant Flow|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571762|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571763|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571764|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571765|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571766|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571767|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571768|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571769|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571770|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571771|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571772|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571773|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571774|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571775|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571776|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571777|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571778|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571779|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571780|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571781|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571782|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571783|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571784|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571785|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571786|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571787|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571788|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571789|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571790|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571791|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571792|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571793|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571794|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571795|NCT00587678|E3|Reported Event|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
571796|NCT00587678|E2|Reported Event|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
571797|NCT00587678|E1|Reported Event|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
571798|NCT00587639|B1|Baseline|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
571799|NCT00587639|P1|Participant Flow|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
571800|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
571801|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
571802|NCT00587639|E1|Reported Event|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
571803|NCT00587587|B3|Baseline|Total|Total of all reporting groups
571804|NCT00587587|B2|Baseline|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571805|NCT00587587|B1|Baseline|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571806|NCT00587587|P2|Participant Flow|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571807|NCT00587587|P1|Participant Flow|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571808|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571809|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571810|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571811|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571812|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571813|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571814|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571815|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
571816|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571817|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571818|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571819|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571820|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571821|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571822|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571823|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
571824|NCT00587587|E2|Reported Event|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571825|NCT00587587|E1|Reported Event|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
571826|NCT00587483|B4|Baseline|Total|Total of all reporting groups
571827|NCT00587483|B3|Baseline|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571828|NCT00587483|B2|Baseline|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571829|NCT00587483|B1|Baseline|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571830|NCT00587483|P3|Participant Flow|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571831|NCT00587483|P2|Participant Flow|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571832|NCT00587483|P1|Participant Flow|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571833|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571834|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571835|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571836|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571837|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571838|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571839|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571840|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571841|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571842|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571843|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571844|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571845|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571846|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571847|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571848|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571849|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571850|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571851|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571852|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571853|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571854|NCT00587483|E3|Reported Event|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571855|NCT00587483|E2|Reported Event|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571856|NCT00587483|E1|Reported Event|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
571857|NCT00587457|B4|Baseline|Total|Total of all reporting groups
571858|NCT00587457|B3|Baseline|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571859|NCT00587457|B2|Baseline|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571860|NCT00587457|B1|Baseline|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571861|NCT00587457|P3|Participant Flow|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571862|NCT00587457|P2|Participant Flow|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571863|NCT00587457|P1|Participant Flow|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571864|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571865|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571866|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571867|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571868|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571869|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571870|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571871|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571872|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571873|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571874|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571875|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571876|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
572159|NCT00586625|B2|Baseline|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
571877|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571878|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571879|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571880|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571881|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571882|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571883|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571884|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571885|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571886|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571887|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571888|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571889|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571890|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571891|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571892|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571893|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571894|NCT00587457|E3|Reported Event|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571895|NCT00587457|E2|Reported Event|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571896|NCT00587457|E1|Reported Event|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
571897|NCT00587431|B3|Baseline|Total|Total of all reporting groups
571898|NCT00587431|B2|Baseline|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
571899|NCT00587431|B1|Baseline|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
571900|NCT00587431|P2|Participant Flow|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
571901|NCT00587431|P1|Participant Flow|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
571902|NCT00587431|O1|Outcome|All Participants|All participants
571903|NCT00587431|O4|Outcome|Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)|"(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
571904|NCT00587431|O3|Outcome|Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
571905|NCT00587431|O2|Outcome|Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
571906|NCT00587431|O1|Outcome|Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
571907|NCT00587431|E2|Reported Event|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
571908|NCT00587431|E1|Reported Event|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
571909|NCT00587288|B3|Baseline|Total|Total of all reporting groups
571910|NCT00587288|B2|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571911|NCT00587288|B1|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571912|NCT00587288|P2|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571913|NCT00587288|P1|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571914|NCT00587288|O2|Outcome|Placebo|Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571915|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571916|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571917|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571918|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571919|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571920|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571921|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571922|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571923|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571924|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571925|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571926|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571927|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571928|NCT00587288|E2|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571929|NCT00587288|E1|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
571930|NCT00587223|B1|Baseline|Apligraf/Control|Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)
571931|NCT00587223|P1|Participant Flow|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
571932|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
571933|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
571934|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
571935|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
571936|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
571937|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
571938|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
571939|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
575754|NCT00577135|O4|Outcome|High Intensification|
571940|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesions receive standard wound dressings.
571941|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
571942|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesion receives standard wound dressings.
571943|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
571944|NCT00587223|E1|Reported Event|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
571945|NCT00587171|B3|Baseline|Total|Total of all reporting groups
571946|NCT00587171|B2|Baseline|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571947|NCT00587171|B1|Baseline|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571948|NCT00587171|P2|Participant Flow|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571949|NCT00587171|P1|Participant Flow|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571950|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571951|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571952|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571953|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571954|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571955|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571956|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571957|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571958|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571959|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571960|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571961|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571962|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571963|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571964|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571965|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571966|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571967|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571968|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571969|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571970|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571971|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571972|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
572160|NCT00586625|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
571973|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571974|NCT00587171|E2|Reported Event|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
571975|NCT00587171|E1|Reported Event|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
571976|NCT00587158|B3|Baseline|Total|Total of all reporting groups
571977|NCT00587158|B2|Baseline|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571978|NCT00587158|B1|Baseline|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571979|NCT00587158|P2|Participant Flow|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive therapy consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). In addition, subjects in this group will receive the study medication paricalcitol (Zemplar®).
571980|NCT00587158|P1|Participant Flow|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571981|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571982|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571983|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571984|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571985|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571986|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571987|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571988|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571989|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571990|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571991|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571992|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571993|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571994|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571995|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
571996|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571997|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
575755|NCT00577135|O3|Outcome|Low Intensification|
571998|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
571999|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
572000|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
572001|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
572002|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
572003|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
572004|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
572005|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
572006|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
572007|NCT00587158|E2|Reported Event|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
572008|NCT00587158|E1|Reported Event|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
572009|NCT00587132|B5|Baseline|Total|Total of all reporting groups
572010|NCT00587132|B4|Baseline|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
572011|NCT00587132|B3|Baseline|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572012|NCT00587132|B2|Baseline|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572013|NCT00587132|B1|Baseline|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572014|NCT00587132|P4|Participant Flow|Clinical Symptoms of Pancreatic Cancer, Normal CT|Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
572015|NCT00587132|P3|Participant Flow|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572016|NCT00587132|P2|Participant Flow|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572017|NCT00587132|P1|Participant Flow|New Onset Diabetes|"Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572018|NCT00587132|O4|Outcome|Clinical Symptoms of Pancreatic Cancer, Normal CT|"Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572019|NCT00587132|O3|Outcome|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572020|NCT00587132|O2|Outcome|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572021|NCT00587132|O1|Outcome|New Onset Diabetes|"Adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572022|NCT00587132|E4|Reported Event|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
572023|NCT00587132|E3|Reported Event|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572024|NCT00587132|E2|Reported Event|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572025|NCT00587132|E1|Reported Event|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
572026|NCT00587067|B1|Baseline|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
572027|NCT00587067|P1|Participant Flow|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
572028|NCT00587067|O1|Outcome|Floxuridine + Dexamethasone|Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
572029|NCT00587067|O1|Outcome|Floxuridine + Dexamethasone|Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
572030|NCT00587067|O1|Outcome|Floxuridine + Dexamethasone|Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
572031|NCT00587067|E1|Reported Event|Floxuridine + Dexamethasone|"FLOXURIDINE: [0.16* mg/kg/day X 30 ml] / pump flow rate~* If the patient is >25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."
572032|NCT00587054|B1|Baseline|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
572033|NCT00587054|P1|Participant Flow|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
572034|NCT00587054|O1|Outcome|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
572035|NCT00587054|E1|Reported Event|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
572036|NCT00587041|B4|Baseline|Total|Total of all reporting groups
572037|NCT00587041|B3|Baseline|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
572038|NCT00587041|B2|Baseline|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
572039|NCT00587041|B1|Baseline|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
572040|NCT00587041|P3|Participant Flow|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
572041|NCT00587041|P2|Participant Flow|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
572042|NCT00587041|P1|Participant Flow|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
572043|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
572161|NCT00586625|P2|Participant Flow|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
572044|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
572045|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
572046|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
572047|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
572048|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
572049|NCT00587041|E3|Reported Event|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
572050|NCT00587041|E2|Reported Event|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
572051|NCT00587041|E1|Reported Event|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
572052|NCT00586898|B1|Baseline|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
572053|NCT00586898|P1|Participant Flow|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
572054|NCT00586898|O1|Outcome|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
572055|NCT00586898|E1|Reported Event|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
572056|NCT00586846|B1|Baseline|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
572057|NCT00586846|P1|Participant Flow|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
572058|NCT00586846|O1|Outcome|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
572059|NCT00586846|E1|Reported Event|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
572060|NCT00586820|B3|Baseline|Total|Total of all reporting groups
572061|NCT00586820|B2|Baseline|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
572062|NCT00586820|B1|Baseline|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
572063|NCT00586820|P2|Participant Flow|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
572064|NCT00586820|P1|Participant Flow|BQ-123|The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
572065|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
572066|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
572067|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
572068|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
572069|NCT00586820|E2|Reported Event|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion for 20 minutes prior to PCI.
572070|NCT00586820|E1|Reported Event|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
572071|NCT00586729|B3|Baseline|Total|Total of all reporting groups
572072|NCT00586729|B2|Baseline|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572073|NCT00586729|B1|Baseline|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572074|NCT00586729|P2|Participant Flow|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572075|NCT00586729|P1|Participant Flow|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572076|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572077|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572078|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572079|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572080|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572081|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572082|NCT00586729|E2|Reported Event|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572083|NCT00586729|E1|Reported Event|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
572084|NCT00586716|B3|Baseline|Total|Total of all reporting groups
572085|NCT00586716|B2|Baseline|IVIG With Living Donor|Intravenous immune globulin for patients who have living donors with positive crossmatch results.
572086|NCT00586716|B1|Baseline|IVIG no Living Donor|Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
572087|NCT00586716|P2|Participant Flow|Group 2 Intravenous Immune Globulin With Living Donor|"Patients who have living donors with positive crossmatch results.~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
572088|NCT00586716|P1|Participant Flow|Group 1 Intravenous Immune Globulin no Living Donor|"Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
572089|NCT00586716|O2|Outcome|Group 2 Intravenous Immune Globulin|"Intravenous immune globulin for patients who have living donors with positive crossmatch results.~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
572090|NCT00586716|O1|Outcome|Group 1 Intravenous Immune Globulin|"Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
572091|NCT00586716|O1|Outcome|Intravenous Immune Globulin|Intravenous immune globulin for patients who have living donors with positive crossmatch results
572092|NCT00586716|E2|Reported Event|Group 2 Intravenous Immune Globulin|Group 2 intravenous immune globulin WITH living donor
572093|NCT00586716|E1|Reported Event|Group 1 Intravenous Immune Globulin|Group 1 with Intravenous immune globulin with no living donor
572094|NCT00586703|B1|Baseline|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
572095|NCT00586703|P1|Participant Flow|Experimental: NK-CD56|"NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors~NK Cell Infusion following SCT from mismatched donors : The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
572096|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
572097|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
572098|NCT00586703|E1|Reported Event|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
572099|NCT00586690|B3|Baseline|Total|Total of all reporting groups
572100|NCT00586690|B2|Baseline|Donor Apheresis|Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
572101|NCT00586690|B1|Baseline|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
572162|NCT00586625|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
572102|NCT00586690|P2|Participant Flow|Donor Apheresis|Leukapheresis was repeated daily up to 3 days until the target dose of cells was reached (preferably without donor receiving growth factors). When possible, cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These collections, which are extra cells collected from the donor following initial collections for transplant were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
572103|NCT00586690|P1|Participant Flow|NK Cell Infusion|NK Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
572104|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
572105|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
572106|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
572107|NCT00586690|O1|Outcome|NK Cell Infusion|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:~The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion."
572108|NCT00586690|E1|Reported Event|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
572109|NCT00586664|B4|Baseline|Total|Total of all reporting groups
572110|NCT00586664|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572111|NCT00586664|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572112|NCT00586664|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572113|NCT00586664|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572114|NCT00586664|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572115|NCT00586664|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572116|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572117|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572118|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572119|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572120|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572121|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572122|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572123|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572124|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572125|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572126|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572127|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572128|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572129|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572130|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572131|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572132|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572133|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572134|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572135|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572136|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572137|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572138|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572139|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572140|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572141|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572142|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572143|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572144|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572145|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572146|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572147|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572148|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572149|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572150|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572151|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572152|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572153|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572154|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572155|NCT00586664|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572156|NCT00586664|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572157|NCT00586664|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
572158|NCT00586625|B3|Baseline|Total|Total of all reporting groups
575756|NCT00577135|O2|Outcome|Continuous Infusion|
572164|NCT00586625|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
572165|NCT00586625|E2|Reported Event|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
572166|NCT00586625|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
572167|NCT00586612|B3|Baseline|Total|Total of all reporting groups
572168|NCT00586612|B2|Baseline|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572169|NCT00586612|B1|Baseline|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572170|NCT00586612|P2|Participant Flow|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572171|NCT00586612|P1|Participant Flow|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572172|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572173|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572174|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572175|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572176|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572177|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572178|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572179|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572180|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572181|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572182|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572183|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572184|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572185|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572186|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572187|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572188|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572189|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572190|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572191|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572192|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572193|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572194|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572195|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572196|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572197|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572198|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572199|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572200|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572201|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572202|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572203|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572204|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572205|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572206|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572207|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572208|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572209|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572210|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572211|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572212|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572238|NCT00586573|O1|Outcome|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
572239|NCT00586573|E1|Reported Event|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
572213|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572214|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572215|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572216|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572217|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572218|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572219|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572220|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572221|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572222|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572223|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572224|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572225|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572226|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572227|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572228|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572229|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572230|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572231|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572232|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572233|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572234|NCT00586612|E2|Reported Event|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572235|NCT00586612|E1|Reported Event|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
572236|NCT00586573|B1|Baseline|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
572237|NCT00586573|P1|Participant Flow|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
572240|NCT00586521|B1|Baseline|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
572241|NCT00586521|P1|Participant Flow|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
572242|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
572243|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
572244|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
572245|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
572246|NCT00586521|E1|Reported Event|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
572247|NCT00586495|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572248|NCT00586495|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572249|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572250|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572251|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572252|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572253|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572254|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572255|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572256|NCT00586495|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
572257|NCT00586482|B3|Baseline|Total|Total of all reporting groups
572258|NCT00586482|B2|Baseline|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572259|NCT00586482|B1|Baseline|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572260|NCT00586482|P2|Participant Flow|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572261|NCT00586482|P1|Participant Flow|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572262|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572284|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
575757|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
572263|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572264|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572265|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572266|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572267|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572268|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572269|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572270|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572271|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572272|NCT00586482|E2|Reported Event|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572273|NCT00586482|E1|Reported Event|Nicotine Lozenge|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
572274|NCT00586469|B3|Baseline|Total|Total of all reporting groups
572275|NCT00586469|B2|Baseline|New Bulk|This group received a full dose of Fluviral made from new material
572276|NCT00586469|B1|Baseline|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572277|NCT00586469|P2|Participant Flow|New Bulk|This group received a full dose of Fluviral made from new material
572278|NCT00586469|P1|Participant Flow|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572279|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572280|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572281|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572282|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572283|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
575758|NCT00577135|O4|Outcome|High Intensification|
572285|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572286|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572287|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572288|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572289|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572290|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572291|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572292|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572293|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572294|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572295|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572296|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572297|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
572298|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572299|NCT00586469|E2|Reported Event|New Bulk|This group received a full dose of Fluviral made from new material
572300|NCT00586469|E1|Reported Event|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
572301|NCT00586339|B4|Baseline|Total|Total of all reporting groups
572302|NCT00586339|B3|Baseline|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572303|NCT00586339|B2|Baseline|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572304|NCT00586339|B1|Baseline|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572305|NCT00586339|P3|Participant Flow|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572306|NCT00586339|P2|Participant Flow|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572307|NCT00586339|P1|Participant Flow|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572308|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572309|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572310|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572311|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572312|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572313|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572314|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572315|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572316|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572436|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
572317|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572318|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572319|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572320|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572321|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572322|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572323|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572324|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572325|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572326|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572327|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572328|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572329|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572330|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572331|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572332|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572333|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572334|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572335|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572336|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572337|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572437|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
575759|NCT00577135|O3|Outcome|Low Intensification|
572338|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572339|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572340|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572341|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572342|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572343|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572344|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572345|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572346|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572347|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572348|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572349|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572350|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572351|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572352|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572353|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572354|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572355|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572356|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572357|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572358|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572438|NCT00586196|E2|Reported Event|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
572359|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572360|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572361|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572362|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572363|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572364|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572365|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572366|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572367|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572368|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572369|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572370|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572371|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572372|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572373|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572374|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572375|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572376|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572377|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572378|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572379|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572439|NCT00586196|E1|Reported Event|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
572440|NCT00586170|B3|Baseline|Total|Total of all reporting groups
572380|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572381|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572382|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572383|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572384|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572385|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572386|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572387|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572388|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572389|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572390|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572391|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572392|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572393|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572394|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572395|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572396|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572397|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572398|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572399|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572400|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572616|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
572401|NCT00586339|E3|Reported Event|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572402|NCT00586339|E2|Reported Event|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572403|NCT00586339|E1|Reported Event|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
572404|NCT00586326|B1|Baseline|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
572405|NCT00586326|P1|Participant Flow|Enrolled|Women with DCIS who were willing to enroll and consented
572406|NCT00586326|O4|Outcome|Poor|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
572407|NCT00586326|O3|Outcome|Fair|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years
572408|NCT00586326|O2|Outcome|Good|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years
572409|NCT00586326|O1|Outcome|Excellent|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Excellent' at 5 years
572410|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
572411|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
572412|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
572413|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
572414|NCT00586326|E1|Reported Event|Intent to Treat|Enrolled subjects with MammoSite device placed
572415|NCT00586313|B1|Baseline|Participants Undergoing the Tru-Cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
572416|NCT00586313|P1|Participant Flow|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
572417|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
572418|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
572419|NCT00586313|E1|Reported Event|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
572420|NCT00586261|B3|Baseline|Total|Total of all reporting groups
572421|NCT00586261|B2|Baseline|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
572422|NCT00586261|B1|Baseline|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
572423|NCT00586261|P2|Participant Flow|Placebo|Placebo 30 mg daily for 6 months
572424|NCT00586261|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg daily for 6 months
572425|NCT00586261|O2|Outcome|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
572426|NCT00586261|O1|Outcome|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
572427|NCT00586261|E2|Reported Event|Placebo|Placebo 30 mg daily for six months
572428|NCT00586261|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg daily for six months
572429|NCT00586196|B3|Baseline|Total|Total of all reporting groups
572430|NCT00586196|B2|Baseline|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
572431|NCT00586196|B1|Baseline|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
572432|NCT00586196|P2|Participant Flow|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
572433|NCT00586196|P1|Participant Flow|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
572434|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
572435|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
572441|NCT00586170|B2|Baseline|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572442|NCT00586170|B1|Baseline|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572443|NCT00586170|P2|Participant Flow|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572444|NCT00586170|P1|Participant Flow|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572445|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572446|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572447|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572448|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572449|NCT00586170|E2|Reported Event|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572450|NCT00586170|E1|Reported Event|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
572451|NCT00586157|B1|Baseline|Entire Study Population|
572452|NCT00586157|P2|Participant Flow|Placebo Then MTS|Placebo in first intervention then MTS in second intervention
572453|NCT00586157|P1|Participant Flow|MTS Then Placebo|MTS in first intervention then Placebo in second intervention
572454|NCT00586157|O2|Outcome|Placebo|
572455|NCT00586157|O1|Outcome|MTS (Drug A)|
572456|NCT00586157|O2|Outcome|Placebo|
572457|NCT00586157|O1|Outcome|MTS (Drug A)|
572458|NCT00586157|O2|Outcome|Placebo|
572459|NCT00586157|O1|Outcome|MTS (Drug A)|
572460|NCT00586157|E2|Reported Event|Placebo|
572461|NCT00586157|E1|Reported Event|MTS (Drug A)|
572462|NCT00586105|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572463|NCT00586105|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572464|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572465|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572466|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572467|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572468|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572469|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572470|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572471|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572472|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572473|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572474|NCT00586105|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
572475|NCT00586066|B3|Baseline|Total|Total of all reporting groups
572476|NCT00586066|B2|Baseline|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572477|NCT00586066|B1|Baseline|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572478|NCT00586066|P2|Participant Flow|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572479|NCT00586066|P1|Participant Flow|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572480|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572481|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572482|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572483|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572484|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572485|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572486|NCT00586066|E2|Reported Event|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572487|NCT00586066|E1|Reported Event|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
572488|NCT00585975|B3|Baseline|Total|Total of all reporting groups
572489|NCT00585975|B2|Baseline|Xibrom 0.09%|
572490|NCT00585975|B1|Baseline|Bromfenac Ophthalmic Solution 0.18%|
572491|NCT00585975|P2|Participant Flow|Xibrom 0.09%|
572492|NCT00585975|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.18%|
572493|NCT00585975|O2|Outcome|Xibrom 0.09%|
572494|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
572495|NCT00585975|O2|Outcome|Xibrom 0.09%|
572496|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
572497|NCT00585975|E2|Reported Event|Xibrom 0.09%|
572498|NCT00585975|E1|Reported Event|Bromfenac Ophthalmic Solution 0.18%|
572499|NCT00585923|B3|Baseline|Total|Total of all reporting groups
572500|NCT00585923|B2|Baseline|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572501|NCT00585923|B1|Baseline|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572502|NCT00585923|P2|Participant Flow|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572503|NCT00585923|P1|Participant Flow|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572504|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572505|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572506|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572507|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572508|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572509|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572510|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572511|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572512|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572513|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572514|NCT00585923|E2|Reported Event|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
572515|NCT00585923|E1|Reported Event|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
572540|NCT00585650|P2|Participant Flow|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
572541|NCT00585650|P1|Participant Flow|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
572516|NCT00585910|B1|Baseline|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
572517|NCT00585910|P1|Participant Flow|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
572518|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
572519|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
572520|NCT00585910|E2|Reported Event|ATMX and OROS MPH|Partial responders to ATMX alone entered into the ATMX and OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
572521|NCT00585910|E1|Reported Event|ATMX Only|Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase.
572522|NCT00585715|B3|Baseline|Total|Total of all reporting groups
572523|NCT00585715|B2|Baseline|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572524|NCT00585715|B1|Baseline|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572525|NCT00585715|P2|Participant Flow|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572526|NCT00585715|P1|Participant Flow|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572527|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572528|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572529|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572530|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572531|NCT00585715|E2|Reported Event|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572532|NCT00585715|E1|Reported Event|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
572533|NCT00585689|B1|Baseline|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
572534|NCT00585689|P1|Participant Flow|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
572535|NCT00585689|O1|Outcome|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
572536|NCT00585689|E1|Reported Event|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
572537|NCT00585650|B3|Baseline|Total|Total of all reporting groups
572538|NCT00585650|B2|Baseline|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
572539|NCT00585650|B1|Baseline|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
572542|NCT00585650|O2|Outcome|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
572543|NCT00585650|O1|Outcome|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
572544|NCT00585650|E2|Reported Event|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
572545|NCT00585650|E1|Reported Event|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
572546|NCT00585637|B5|Baseline|Total|Total of all reporting groups
572547|NCT00585637|B4|Baseline|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572548|NCT00585637|B3|Baseline|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572549|NCT00585637|B2|Baseline|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572550|NCT00585637|B1|Baseline|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572551|NCT00585637|P4|Participant Flow|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572552|NCT00585637|P3|Participant Flow|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572553|NCT00585637|P2|Participant Flow|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572554|NCT00585637|P1|Participant Flow|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572555|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572556|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572557|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572558|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572559|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572560|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572561|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572562|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572563|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572564|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572565|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572566|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572567|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572568|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572569|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572570|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572571|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572572|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572573|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572574|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572575|NCT00585637|E4|Reported Event|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572576|NCT00585637|E3|Reported Event|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572577|NCT00585637|E2|Reported Event|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
572578|NCT00585637|E1|Reported Event|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
572579|NCT00585585|B1|Baseline|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
572580|NCT00585585|P1|Participant Flow|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
572581|NCT00585585|O1|Outcome|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
572582|NCT00585585|E1|Reported Event|Betahistine Dihydrochloride|All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
572583|NCT00585546|B1|Baseline|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572584|NCT00585546|P1|Participant Flow|LVAD and (Intended) Clenbuterol|"Participants, all of whom received LVAD implantation, were to begin clenbuterol treatment 12 weeks after their implantation.~Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months."
572585|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572586|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572587|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572588|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572589|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572590|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572591|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572592|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572593|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572594|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572595|NCT00585546|O1|Outcome|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572596|NCT00585546|E1|Reported Event|LVAD and Clenbuterol|clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
572597|NCT00585533|B1|Baseline|All Participants|All participants enrolled in trial.
572598|NCT00585533|P1|Participant Flow|All Participants|All participants enrolled in trial.
572599|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
572600|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
572601|NCT00585533|E1|Reported Event|All Participants|All participants enrolled in trial.
572602|NCT00585494|B1|Baseline|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
572603|NCT00585494|P1|Participant Flow|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
572604|NCT00585494|O1|Outcome|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
572605|NCT00585494|E1|Reported Event|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
572606|NCT00585468|B1|Baseline|Entire Study Population|Includes groups randomized to the Fed State first and to the Fasted State first
572607|NCT00585468|P2|Participant Flow|Fasting State First, Then Fed State|720 mg mycophenolate sodium orally twice daily separated from food by 2 hours for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily with a meal in the second intervention period.
572608|NCT00585468|P1|Participant Flow|Fed State First, Then Fasting State|720 milligrams (mg) mycophenolate sodium orally twice daily with a meal for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily separated by food by 2 hours in the second intervention period.
572609|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
572610|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
572611|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
572612|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
572613|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
572614|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
572615|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
575760|NCT00577135|O2|Outcome|Continuous Infusion|
572617|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
572618|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
572619|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
572620|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
572621|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
572622|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
572623|NCT00585468|O2|Outcome|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
572624|NCT00585468|O1|Outcome|Myfortic - Fed State|Mycophenolate sodium taken with a meal
572625|NCT00585468|E2|Reported Event|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
572626|NCT00585468|E1|Reported Event|Myfortic - Fed State|Mycophenolate sodium taken with a meal
572627|NCT00585377|B1|Baseline|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
572628|NCT00585377|P1|Participant Flow|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
572629|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
572630|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
572631|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
572632|NCT00585377|E1|Reported Event|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
572633|NCT00585351|B7|Baseline|Total|Total of all reporting groups
572634|NCT00585351|B6|Baseline|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572635|NCT00585351|B5|Baseline|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572636|NCT00585351|B4|Baseline|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572637|NCT00585351|B3|Baseline|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572638|NCT00585351|B2|Baseline|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
572639|NCT00585351|B1|Baseline|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
572640|NCT00585351|P8|Participant Flow|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572641|NCT00585351|P7|Participant Flow|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572642|NCT00585351|P6|Participant Flow|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572643|NCT00585351|P5|Participant Flow|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572644|NCT00585351|P4|Participant Flow|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
572645|NCT00585351|P3|Participant Flow|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
572646|NCT00585351|P2|Participant Flow|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
572647|NCT00585351|P1|Participant Flow|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
572648|NCT00585351|O4|Outcome|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572649|NCT00585351|O3|Outcome|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572650|NCT00585351|O2|Outcome|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572651|NCT00585351|O1|Outcome|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572652|NCT00585351|O2|Outcome|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
572653|NCT00585351|O1|Outcome|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
572654|NCT00585351|E6|Reported Event|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572655|NCT00585351|E5|Reported Event|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
572656|NCT00585351|E4|Reported Event|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572657|NCT00585351|E3|Reported Event|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
572658|NCT00585351|E2|Reported Event|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
572659|NCT00585351|E1|Reported Event|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
572660|NCT00585325|B3|Baseline|Total|Total of all reporting groups
572661|NCT00585325|B2|Baseline|Instilled Placebo (0.9% Normal Saline)|receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
572662|NCT00585325|B1|Baseline|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
572663|NCT00585325|P2|Participant Flow|Instilled Placebo (0.9% Normal Saline)|receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
572664|NCT00585325|P1|Participant Flow|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
572665|NCT00585325|O2|Outcome|Instilled Placebo (0.9% Normal Saline)|"receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change~Placebo (0.9% Normal Saline): .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change"
572666|NCT00585325|O1|Outcome|Instilled 1% Lidocaine|"5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change~Instilled 1% Lidocaine: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change"
572667|NCT00585325|E2|Reported Event|Instilled Placebo (0.9% Normal Saline)|receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
572668|NCT00585325|E1|Reported Event|Instilled 1% Lidocaine|5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
572669|NCT00585312|B3|Baseline|Total|Total of all reporting groups
572670|NCT00585312|B2|Baseline|Placebo|Matching placebo
572671|NCT00585312|B1|Baseline|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
572672|NCT00585312|P2|Participant Flow|Placebo|Matching placebo
572673|NCT00585312|P1|Participant Flow|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
572674|NCT00585312|O2|Outcome|Placebo|Matching placebo
572675|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
572676|NCT00585312|O2|Outcome|Placebo|Matching placebo
572677|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
572678|NCT00585312|O2|Outcome|Placebo|Matching placebo
572679|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
572680|NCT00585312|O2|Outcome|Placebo|Matching placebo
572681|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
572682|NCT00585312|E2|Reported Event|Placebo|Matching placebo
572683|NCT00585312|E1|Reported Event|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
572684|NCT00585286|B1|Baseline|Fractional CO2 Laser System|Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
572685|NCT00585286|P1|Participant Flow|Fractional Carbon Dioxide Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
572686|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
572687|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
572688|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
572689|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
572690|NCT00585286|E1|Reported Event|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
572691|NCT00585247|B3|Baseline|Total|Total of all reporting groups
572692|NCT00585247|B2|Baseline|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks."
572693|NCT00585247|B1|Baseline|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment imiquimod 5% cream for 8 weeks."
572694|NCT00585247|P2|Participant Flow|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 13) were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
572695|NCT00585247|P1|Participant Flow|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 14) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
572696|NCT00585247|O2|Outcome|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks"
572697|NCT00585247|O1|Outcome|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks"
572698|NCT00585247|E2|Reported Event|Placebo|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
572699|NCT00585247|E1|Reported Event|Imiquimod|"Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks~Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)"
572700|NCT00585221|B1|Baseline|Group 1|
572701|NCT00585221|P1|Participant Flow|All Patients|All participants enrolled.
572702|NCT00585221|O1|Outcome|All Patients|All participants enrolled
572703|NCT00585221|O1|Outcome|All Patients|All participants enrolled
572704|NCT00585221|E1|Reported Event|All Enrolled|All participants enrolled
572705|NCT00585182|B1|Baseline|Enoxaparin 0.5mg/kg Once Daily|
572706|NCT00585182|P1|Participant Flow|Enoxaparin 0.5mg/kg Once Daily|
572707|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
572708|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
572709|NCT00585182|E1|Reported Event|Enoxaparin 0.5mg/kg Once Daily|
572710|NCT00585169|B1|Baseline|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
572711|NCT00585169|P1|Participant Flow|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
572712|NCT00585169|O1|Outcome|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
572713|NCT00585169|E3|Reported Event|Memantine 30mg|
572714|NCT00585169|E2|Reported Event|Memantine 20mg|
572715|NCT00585169|E1|Reported Event|Memantine 10mg|
572716|NCT00585104|B1|Baseline|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
572717|NCT00585104|P1|Participant Flow|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
572718|NCT00585104|O1|Outcome|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
572719|NCT00585104|E1|Reported Event|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
572720|NCT00585078|B1|Baseline|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
572721|NCT00585078|P1|Participant Flow|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
572722|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
572723|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
572724|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
572725|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
572726|NCT00585078|E1|Reported Event|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
572727|NCT00585052|B1|Baseline|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
572728|NCT00585052|P1|Participant Flow|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
572729|NCT00585052|O1|Outcome|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
572730|NCT00585052|O1|Outcome|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
572731|NCT00585052|E1|Reported Event|Paclitaxel and Lovastatin|"Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.~Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly~Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject."
572732|NCT00585039|B3|Baseline|Total|Total of all reporting groups
572733|NCT00585039|B2|Baseline|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
572734|NCT00585039|B1|Baseline|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
572735|NCT00585039|P2|Participant Flow|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
572736|NCT00585039|P1|Participant Flow|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
572737|NCT00585039|O2|Outcome|Albuterol|
572738|NCT00585039|O1|Outcome|Levalbuterol|
572739|NCT00585039|O2|Outcome|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
572740|NCT00585039|O1|Outcome|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
572741|NCT00585039|E2|Reported Event|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
572742|NCT00585039|E1|Reported Event|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
572743|NCT00585013|B3|Baseline|Total|Total of all reporting groups
572744|NCT00585013|B2|Baseline|2 Placebo|Placebo delivery of oxygen at standard dose.
572745|NCT00585013|B1|Baseline|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572746|NCT00585013|P2|Participant Flow|2 Placebo|Placebo delivery of oxygen at standard dose.
572747|NCT00585013|P1|Participant Flow|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572748|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
572749|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572750|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
572751|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572752|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
572753|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572754|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
572755|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572756|NCT00585013|O2|Outcome|Placebo|Placebo delivery of oxygen at standard dose.
572757|NCT00585013|O1|Outcome|Nitric Oxide Delivery Group|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572758|NCT00585013|E2|Reported Event|2 Placebo|Placebo delivery of oxygen at standard dose.
572759|NCT00585013|E1|Reported Event|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
572760|NCT00584987|B5|Baseline|Total|Total of all reporting groups
572761|NCT00584987|B4|Baseline|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572762|NCT00584987|B3|Baseline|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572763|NCT00584987|B2|Baseline|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572764|NCT00584987|B1|Baseline|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572765|NCT00584987|P4|Participant Flow|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572766|NCT00584987|P3|Participant Flow|PL FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572767|NCT00584987|P2|Participant Flow|FF + PL OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572768|NCT00584987|P1|Participant Flow|PL FF + PL OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572769|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572770|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
573118|NCT00583713|E2|Reported Event|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
572771|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572772|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572773|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572774|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572775|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572776|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572777|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572778|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572779|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572780|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572781|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572782|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572783|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572784|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572785|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572786|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572787|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572788|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572789|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572790|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572791|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572792|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572793|NCT00584987|E4|Reported Event|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572794|NCT00584987|E3|Reported Event|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572795|NCT00584987|E2|Reported Event|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572796|NCT00584987|E1|Reported Event|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
572797|NCT00584948|B3|Baseline|Total|Total of all reporting groups
572798|NCT00584948|B2|Baseline|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
572799|NCT00584948|B1|Baseline|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
572800|NCT00584948|P2|Participant Flow|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
572801|NCT00584948|P1|Participant Flow|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
572802|NCT00584948|O2|Outcome|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
572803|NCT00584948|O1|Outcome|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
572804|NCT00584948|O2|Outcome|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
572805|NCT00584948|O1|Outcome|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
572806|NCT00584948|E2|Reported Event|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
572807|NCT00584948|E1|Reported Event|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
572808|NCT00584935|B1|Baseline|Rituximab|
572809|NCT00584935|P1|Participant Flow|Rituximab|
575761|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
572810|NCT00584935|O1|Outcome|Rituximab|"The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).~Rituximab: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15)."
572811|NCT00584935|O1|Outcome|Rituximab|"The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).~Rituximab: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15)."
572812|NCT00584935|O1|Outcome|Rituximab|"The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).~Rituximab: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15)."
572813|NCT00584935|O1|Outcome|Rituximab|
572814|NCT00584935|E1|Reported Event|Rituximab|
572815|NCT00584909|B1|Baseline|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
572816|NCT00584909|P1|Participant Flow|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
572817|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
572818|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
572819|NCT00584909|E1|Reported Event|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
572820|NCT00584857|B1|Baseline|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
572821|NCT00584857|P1|Participant Flow|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
572822|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
572823|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
572824|NCT00584857|E1|Reported Event|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
572825|NCT00584844|B1|Baseline|F Tularensis Vaccine (0.0025 mL)|"Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.~Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20)."
572826|NCT00584844|P1|Participant Flow|F Tularensis Vaccine (0.0025 mL)|"Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.~Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20)."
572827|NCT00584844|O1|Outcome|Percent of Subjects|Percentage of subjects in specific category
572828|NCT00584844|O1|Outcome|Percent of Subjects|Percentage of subjects in specific category
572829|NCT00584844|O1|Outcome|Percent of Subjects|Percentage of subjects in specific category
572830|NCT00584844|O2|Outcome|Females|All females in study
572831|NCT00584844|O1|Outcome|Males|All males in study
572832|NCT00584844|E3|Reported Event|Severe|Severe
572833|NCT00584844|E2|Reported Event|Moderate|Moderate
572834|NCT00584844|E1|Reported Event|Mild|Mild
572835|NCT00584831|B1|Baseline|Total Study Population|
572836|NCT00584831|P19|Participant Flow|Group 17 BSOL|balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric
572837|NCT00584831|P18|Participant Flow|Group 6 SLOB|senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric
572838|NCT00584831|P17|Participant Flow|Group 3 LOSB|lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
572839|NCT00584831|P16|Participant Flow|Group 19 BOSL|balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
572840|NCT00584831|P15|Participant Flow|Group 18 BOLS|balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
572841|NCT00584831|P14|Participant Flow|Group 16 BLOS|balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
572842|NCT00584831|P13|Participant Flow|Group 15 BLSO|balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
572843|NCT00584831|P12|Participant Flow|Group 14 OBSL|omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
572844|NCT00584831|P11|Participant Flow|Group 13 OBLS|omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
572845|NCT00584831|P10|Participant Flow|Group 12 OSBL|omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
572846|NCT00584831|P9|Participant Flow|Group 11 OSLB|omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
572847|NCT00584831|P8|Participant Flow|Group 10 SBOL|senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
572848|NCT00584831|P7|Participant Flow|Group 9 SBLO|senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
572849|NCT00584831|P6|Participant Flow|Group 8 SOLB|senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
572850|NCT00584831|P5|Participant Flow|Group 7 SLBO|senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
572851|NCT00584831|P4|Participant Flow|Group 5 LBOS|lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
572852|NCT00584831|P3|Participant Flow|Group 4 LBSO|lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
572853|NCT00584831|P2|Participant Flow|Group 2 LSBO|lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
572854|NCT00584831|P1|Participant Flow|Group1 LSOB|lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric
572855|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
572856|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
572857|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
572858|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
572859|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
572860|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
572861|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
572862|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
572863|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
572864|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
572865|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
572866|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
572867|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
572868|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
572869|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
572870|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
572871|NCT00584831|E4|Reported Event|Balafilcon A|balafilcon A toric contact lens
572872|NCT00584831|E3|Reported Event|Omafilcon A|omafilcon A toric contact lens
572873|NCT00584831|E2|Reported Event|Senofilcon A|senofilcon A toric contact lens
572874|NCT00584831|E1|Reported Event|Lotrafilcon B|lotrafilcon b toric contact lens
572875|NCT00584740|B3|Baseline|Total|Total of all reporting groups
572876|NCT00584740|B2|Baseline|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572877|NCT00584740|B1|Baseline|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572878|NCT00584740|P2|Participant Flow|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572879|NCT00584740|P1|Participant Flow|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572880|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572881|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572882|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572883|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572884|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572885|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572886|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572887|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572888|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572889|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572890|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572891|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572892|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572893|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572894|NCT00584740|E2|Reported Event|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
572895|NCT00584740|E1|Reported Event|AIN457 Twice 10mg/kg|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
572896|NCT00584727|B1|Baseline|Completed Population|Only participants that completed the study are included (n=88)
572897|NCT00584727|P6|Participant Flow|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
572898|NCT00584727|P5|Participant Flow|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
572982|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
572899|NCT00584727|P4|Participant Flow|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
572900|NCT00584727|P3|Participant Flow|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
572901|NCT00584727|P2|Participant Flow|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
572902|NCT00584727|P1|Participant Flow|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
572903|NCT00584727|O3|Outcome|Etafilcon A Sphere|
572904|NCT00584727|O2|Outcome|Alphafilcon A Toric|
572905|NCT00584727|O1|Outcome|Senofilcon A Toric|
572906|NCT00584727|O3|Outcome|Etafilcon A Sphere|
572907|NCT00584727|O2|Outcome|Alphafilcon A Toric|
572908|NCT00584727|O1|Outcome|Senofilcon A Toric|
572909|NCT00584727|O2|Outcome|Alphafilcon A Toric|
572910|NCT00584727|O1|Outcome|Senofilcon A Toric|
572911|NCT00584727|O2|Outcome|Alphafilcon A Toric|
572912|NCT00584727|O1|Outcome|Senofilcon A Toric|
572913|NCT00584727|O3|Outcome|Etafilcon A Sphere|
572914|NCT00584727|O2|Outcome|Alphafilcon A Toric|
572915|NCT00584727|O1|Outcome|Senofilcon A Toric|
572916|NCT00584727|O3|Outcome|Etafilcon A Sphere|
572917|NCT00584727|O2|Outcome|Alphafilcon A Toric|
572918|NCT00584727|O1|Outcome|Senofilcon A Toric|
572919|NCT00584727|E6|Reported Event|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
572920|NCT00584727|E5|Reported Event|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
572921|NCT00584727|E4|Reported Event|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
572922|NCT00584727|E3|Reported Event|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
572923|NCT00584727|E2|Reported Event|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
572924|NCT00584727|E1|Reported Event|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
572925|NCT00584701|B1|Baseline|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
572926|NCT00584701|P1|Participant Flow|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
572927|NCT00584701|O1|Outcome|Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
572928|NCT00584701|O1|Outcome|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
572929|NCT00584701|E1|Reported Event|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
572930|NCT00584558|B1|Baseline|Observational Arm|All patients studied
572931|NCT00584558|P1|Participant Flow|1-Catheter Ablation|There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
572932|NCT00584558|O1|Outcome|1-Observational|There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
572933|NCT00584558|O1|Outcome|1-Catheter Ablation|There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
572934|NCT00584558|E1|Reported Event|Observational Arm|"Patients undergoing catheter ablation.~Catheter Ablation: Catheter Ablation of arrhythmias"
572935|NCT00584480|B1|Baseline|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
572936|NCT00584480|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
572937|NCT00584480|O1|Outcome|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
572938|NCT00584480|E1|Reported Event|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
572939|NCT00584454|B1|Baseline|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
572940|NCT00584454|P1|Participant Flow|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
572941|NCT00584454|O1|Outcome|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
572942|NCT00584454|E1|Reported Event|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
572943|NCT00584415|B1|Baseline|PV Isolation + GP Ablation|All patients received pulmonary vein antrum isolation (PV isolation) and ablation of the major atrial ganglionated plexi (superior left GP, inferior left GP, anterior right GP and inferior right GP). Ganglionated plexi (GP) were identified by delivering high-frequency stimulation (20 Hz) from the ablation catheter. If vagal response (AV block) was initiated by stimulation, that site was counted as a GP site and was then ablated.
572944|NCT00584415|P1|Participant Flow|GP Ablation + PV Isolation|All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF
572945|NCT00584415|O1|Outcome|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
572946|NCT00584415|O1|Outcome|GP Ablation + PV Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
572947|NCT00584415|E1|Reported Event|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
572948|NCT00584402|B1|Baseline|Contrast Sonography|Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
572949|NCT00584402|P1|Participant Flow|Contrast Sonography|"Contrast-enhanced sonography~perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity"
572950|NCT00584402|O1|Outcome|Contrast Sonography|Subjects undergoing contrast sonography
572951|NCT00584402|O1|Outcome|Contrast Sonography|Subjects undergoing contrast sonography
572952|NCT00584402|E1|Reported Event|Contrast Sonography|"Contrast-enhanced sonography~perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity"
572953|NCT00584220|B1|Baseline|All Subjects|Subjects who enrolled and completed the study.
572954|NCT00584220|P2|Participant Flow|Alphafilcon A / Senofilcon A|alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second
572955|NCT00584220|P1|Participant Flow|Senofilcon A / Alphafilcon A|senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second
572956|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
572957|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
572958|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
572959|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
572960|NCT00584220|E2|Reported Event|Alphafilcon A|alphafilcon A toric hydrogel contact lenses worn
572961|NCT00584220|E1|Reported Event|Senofilcon A|senofilcon A toric silicone hydrogel contact lenses worn
573067|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
572962|NCT00584194|B1|Baseline|TSI-GSD 200 RVF Vaccine|"Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.~TSI-GSD 200 RVF Vaccine: Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40."
572963|NCT00584194|P1|Participant Flow|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
572964|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
572965|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
572966|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
572967|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
572968|NCT00584194|O1|Outcome|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
572969|NCT00584194|E1|Reported Event|TSI-GSD 200 RVF Vaccine|Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
572970|NCT00584077|B1|Baseline|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
572971|NCT00584077|P1|Participant Flow|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
572972|NCT00584077|O1|Outcome|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
572973|NCT00584077|E1|Reported Event|Lung Transplant Recipients With Stable Lung Function|Enrolled subjects underwent bronchoscopy to assess for presence of cough reflex in the transpalnted and non-transplanted lung
572974|NCT00583947|B3|Baseline|Total|Total of all reporting groups
572975|NCT00583947|B2|Baseline|LEV/ARF|"Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
572976|NCT00583947|B1|Baseline|ARF/LEV|"Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
572977|NCT00583947|P2|Participant Flow|LEV/ARF|"Cross-over period: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
572978|NCT00583947|P1|Participant Flow|ARF/LEV|"Cross-over period: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
572979|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
572980|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
572981|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
575762|NCT00577135|O4|Outcome|High Intensification|
572983|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
572984|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
572985|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
572986|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
572987|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
572988|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
572989|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
572990|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
572991|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
572992|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
572993|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
572994|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
572995|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
572996|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
572997|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
572998|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
572999|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573000|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
573001|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573002|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573003|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
573004|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573005|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573006|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
573007|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573008|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573009|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
573010|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573011|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573012|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
573013|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573014|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573015|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
573016|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573017|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573018|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
573019|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573020|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573021|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
575763|NCT00577135|O3|Outcome|Low Intensification|
573022|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
573023|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
573024|NCT00583947|E3|Reported Event|Arformoterol 15 Mcg|The experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study.
573025|NCT00583947|E2|Reported Event|Arformoterol 7.5 Mcg|The experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study.
573026|NCT00583947|E1|Reported Event|Levalbuterol 0.63 mg|The experience of participants when treated with levalbuterol during the cross-over portion of the study.
573027|NCT00583908|B1|Baseline|Overall Study Population|Summary for overall study population
573028|NCT00583908|P12|Participant Flow|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573029|NCT00583908|P11|Participant Flow|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573030|NCT00583908|P10|Participant Flow|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573031|NCT00583908|P9|Participant Flow|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573032|NCT00583908|P8|Participant Flow|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573033|NCT00583908|P7|Participant Flow|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573034|NCT00583908|P6|Participant Flow|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573035|NCT00583908|P5|Participant Flow|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573036|NCT00583908|P4|Participant Flow|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573037|NCT00583908|P3|Participant Flow|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573038|NCT00583908|P2|Participant Flow|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573039|NCT00583908|P1|Participant Flow|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573040|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573041|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573042|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573043|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573044|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573045|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573046|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573047|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573048|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573049|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573050|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573051|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573052|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573053|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573054|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573055|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573056|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573057|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573058|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573059|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573060|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573061|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573062|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573063|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573064|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573065|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573066|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573068|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573069|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573070|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573071|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573072|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573073|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573074|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573075|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573076|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
573077|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
573078|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
573079|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
573080|NCT00583908|E12|Reported Event|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573081|NCT00583908|E11|Reported Event|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573082|NCT00583908|E10|Reported Event|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573083|NCT00583908|E9|Reported Event|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573084|NCT00583908|E8|Reported Event|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573085|NCT00583908|E7|Reported Event|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573086|NCT00583908|E6|Reported Event|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573087|NCT00583908|E5|Reported Event|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573088|NCT00583908|E4|Reported Event|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573089|NCT00583908|E3|Reported Event|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573090|NCT00583908|E2|Reported Event|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573091|NCT00583908|E1|Reported Event|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
573092|NCT00583713|B4|Baseline|Total|Total of all reporting groups
573093|NCT00583713|B3|Baseline|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573094|NCT00583713|B2|Baseline|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573095|NCT00583713|B1|Baseline|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573096|NCT00583713|P3|Participant Flow|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573097|NCT00583713|P2|Participant Flow|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573098|NCT00583713|P1|Participant Flow|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573099|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573100|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573101|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573102|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573103|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573104|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573105|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573106|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573107|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573108|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573109|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573110|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573111|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573112|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573113|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573114|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573115|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
573116|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573117|NCT00583713|E3|Reported Event|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
573119|NCT00583713|E1|Reported Event|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
573120|NCT00583700|B3|Baseline|Total|Total of all reporting groups
573121|NCT00583700|B2|Baseline|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
573122|NCT00583700|B1|Baseline|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
573123|NCT00583700|P2|Participant Flow|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
573124|NCT00583700|P1|Participant Flow|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
573125|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
573126|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
573127|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
573128|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
573129|NCT00583700|E2|Reported Event|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
573130|NCT00583700|E1|Reported Event|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
573131|NCT00583661|B1|Baseline|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
573132|NCT00583661|P1|Participant Flow|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
573133|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
573134|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
573135|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
573136|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
573137|NCT00583661|E1|Reported Event|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
573138|NCT00583622|B1|Baseline|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
573139|NCT00583622|P1|Participant Flow|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
573140|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
573141|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
573142|NCT00583622|E1|Reported Event|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
573143|NCT00583596|B1|Baseline|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
573144|NCT00583596|P1|Participant Flow|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
573145|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
573146|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects implanted with Amplatzer duct occluder that have final follow-up taking place 5 yrs., 6 yrs., or 7 yrs., post implant.
573147|NCT00583596|E1|Reported Event|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
573148|NCT00583557|B1|Baseline|Belimumab 10 mg/kg|
573149|NCT00583557|P1|Participant Flow|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
573150|NCT00583557|O1|Outcome|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
573151|NCT00583557|E1|Reported Event|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
573152|NCT00583492|B3|Baseline|Total|Total of all reporting groups
573153|NCT00583492|B2|Baseline|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573438|NCT00582426|B2|Baseline|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573154|NCT00583492|B1|Baseline|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573155|NCT00583492|P2|Participant Flow|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573156|NCT00583492|P1|Participant Flow|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573157|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573158|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573159|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573160|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573161|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573162|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573163|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573164|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573165|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573166|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573167|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573168|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573169|NCT00583492|E2|Reported Event|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
573170|NCT00583492|E1|Reported Event|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10^12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
573171|NCT00583466|B1|Baseline|All Participants|"Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
573172|NCT00583466|P1|Participant Flow|All Participants|"Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
573173|NCT00583466|O3|Outcome|3 Blood Arm|"Polypectomy after injection of autologous blood~Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
573174|NCT00583466|O2|Outcome|2 HPMC Arm|"Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion~HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion"
573175|NCT00583466|O1|Outcome|1 Normal Saline Arm|"Polypectomy with normal saline injected for submucosal cushion creation~Normal saline: Normal saline will be injected under the lesion to create submucosal cushion"
573176|NCT00583466|E1|Reported Event|All Participants|"Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion~OR~Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion"
573177|NCT00583453|B3|Baseline|Total|Total of all reporting groups
573719|NCT00581308|O1|Outcome|Clinical Success at 60 Months|Subjects with occluder in place upon leaving cath lab
573178|NCT00583453|B2|Baseline|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573179|NCT00583453|B1|Baseline|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573180|NCT00583453|P2|Participant Flow|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573181|NCT00583453|P1|Participant Flow|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573182|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573183|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573184|NCT00583453|O2|Outcome|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573185|NCT00583453|O1|Outcome|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573186|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573187|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573188|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573189|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573190|NCT00583453|O2|Outcome|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573191|NCT00583453|O1|Outcome|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573192|NCT00583453|E2|Reported Event|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573193|NCT00583453|E1|Reported Event|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
573194|NCT00583375|B3|Baseline|Total|Total of all reporting groups
573195|NCT00583375|B2|Baseline|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573196|NCT00583375|B1|Baseline|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573197|NCT00583375|P2|Participant Flow|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573198|NCT00583375|P1|Participant Flow|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573199|NCT00583375|O2|Outcome|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573200|NCT00583375|O1|Outcome|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573201|NCT00583375|O2|Outcome|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573202|NCT00583375|O1|Outcome|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573203|NCT00583375|O2|Outcome|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573204|NCT00583375|O1|Outcome|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573205|NCT00583375|O2|Outcome|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573206|NCT00583375|O1|Outcome|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573207|NCT00583375|O2|Outcome|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573208|NCT00583375|O1|Outcome|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573209|NCT00583375|O2|Outcome|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573210|NCT00583375|O1|Outcome|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573211|NCT00583375|E2|Reported Event|Group 2|Standard Rigid Fixation plus Augment® Bone Graft
573212|NCT00583375|E1|Reported Event|Group 1|"Standard Rigid Fixation plus autograft~Standard of Care: Autologous Bone Graft"
573439|NCT00582426|B1|Baseline|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573213|NCT00583362|B1|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573214|NCT00583362|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573215|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573216|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573217|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573218|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573219|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573220|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573221|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573222|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573223|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573224|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573225|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573278|NCT00582907|P3|Participant Flow|Placebo-Rilonacept-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
573226|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573227|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573228|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573229|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573230|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573231|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573232|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573233|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573234|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573235|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573236|NCT00583362|E1|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
573237|NCT00583219|B1|Baseline|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573275|NCT00582933|E1|Reported Event|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
573238|NCT00583219|P1|Participant Flow|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573239|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573240|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573241|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573242|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573243|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573244|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573245|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573276|NCT00582907|B1|Baseline|All Patients Received Both Rilonacept and Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573440|NCT00582426|P2|Participant Flow|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573246|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573247|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573248|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573249|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573250|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573251|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573252|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573253|NCT00583219|E1|Reported Event|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
573254|NCT00583115|B1|Baseline|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
573255|NCT00583115|P1|Participant Flow|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
573256|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
573257|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
573258|NCT00583115|E1|Reported Event|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
573259|NCT00583102|B1|Baseline|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin: Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
573260|NCT00583102|P1|Participant Flow|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin: Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
573261|NCT00583102|O1|Outcome|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin: Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
573262|NCT00583102|E1|Reported Event|Lovastatin Followed by Cytarabine|"The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.~Lovastatin and Cytarabine: Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.~Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day."
573263|NCT00582972|B1|Baseline|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
573264|NCT00582972|P1|Participant Flow|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
573265|NCT00582972|O1|Outcome|Experimental|Subjects received omeprazole 40 mg daily for 30 days
573266|NCT00582972|O1|Outcome|Experimental|omeprazole 40 mg daily for 30 days
573267|NCT00582972|E1|Reported Event|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
573268|NCT00582946|B1|Baseline|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
573269|NCT00582946|P1|Participant Flow|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
573270|NCT00582946|O1|Outcome|Maximum Equivalent Pressure Output|Provision of amplification to treat sensorineural hearing loss with direct-drive hearing aid for acute evaluation of efficacy.
573271|NCT00582946|E1|Reported Event|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
573272|NCT00582933|B1|Baseline|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
573273|NCT00582933|P1|Participant Flow|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
573274|NCT00582933|O1|Outcome|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
573277|NCT00582907|P4|Participant Flow|Placebo-Rilonacept-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
573720|NCT00581308|O1|Outcome|Clinical Success at 36 Months|Subjects with occluder in place upon leaving cath lab
573279|NCT00582907|P2|Participant Flow|Rilonacept-Placebo-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
573280|NCT00582907|P1|Participant Flow|Rilonacept-Placebo-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
573281|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573282|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573283|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573284|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573285|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573286|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573287|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573288|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573289|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573290|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573291|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573347|NCT00582738|O1|Outcome|Standard Treatment - Summary of Actitest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573348|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573292|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573293|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573294|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573295|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573296|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573297|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573298|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573299|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573300|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573301|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573302|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573303|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573304|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
574038|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
573305|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573306|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573307|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573308|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
573309|NCT00582907|E2|Reported Event|Rilonacept|"Adverse events during rilonacept treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
573310|NCT00582907|E1|Reported Event|Placebo|"Adverse events during placebo treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
573311|NCT00582894|B1|Baseline|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
573312|NCT00582894|P1|Participant Flow|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
573313|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
573314|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
573315|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
573316|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
573317|NCT00582894|E1|Reported Event|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
573318|NCT00582816|B1|Baseline|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573319|NCT00582816|P1|Participant Flow|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573441|NCT00582426|P1|Participant Flow|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573320|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573321|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573322|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573323|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573324|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573325|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573326|NCT00582816|O1|Outcome|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573349|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573350|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573442|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573327|NCT00582816|E1|Reported Event|Haploidentical Transplant With NK Cell Infusion|"Patients underwent a standard pre-transplant evaluation, but will also had blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents underwent KIR genotyping and phenotyping, and a donor was selected based on which parent showed the greatest degree of KIR receptor-ligand mismatching. When the donor had been selected he/she underwent a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection was performed utilizing standard procedures. The PBSC was then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This was accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product were analyzed for T cell, stem cell and NK cell content.~Clinimacs Cell Separation System: Depletion of T-cells"
573328|NCT00582790|B1|Baseline|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
573329|NCT00582790|P1|Participant Flow|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
573330|NCT00582790|O1|Outcome|Low-dose IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
573331|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
573332|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
573333|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
573334|NCT00582790|E1|Reported Event|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
573335|NCT00582738|B3|Baseline|Total|Total of all reporting groups
573336|NCT00582738|B2|Baseline|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573337|NCT00582738|B1|Baseline|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573338|NCT00582738|P2|Participant Flow|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573339|NCT00582738|P1|Participant Flow|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573340|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573341|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573342|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573343|NCT00582738|O1|Outcome|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573344|NCT00582738|O4|Outcome|Everolimus - Summary of Fibrotest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573345|NCT00582738|O3|Outcome|Standard Treatment -Summary of Fibrotest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573346|NCT00582738|O2|Outcome|Everolimus -Summary of Actitest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573351|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573352|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573353|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573354|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573355|NCT00582738|O1|Outcome|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573356|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573357|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573358|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573359|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
573360|NCT00582738|E2|Reported Event|EVR (Everolimus)|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
573361|NCT00582738|E1|Reported Event|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.
573362|NCT00582712|B1|Baseline|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
573363|NCT00582712|P1|Participant Flow|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
573364|NCT00582712|O1|Outcome|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
573365|NCT00582712|E1|Reported Event|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
573366|NCT00582660|B3|Baseline|Total|Total of all reporting groups
573367|NCT00582660|B2|Baseline|Placebo|1 tablet BID given for 7 days before surgery
573368|NCT00582660|B1|Baseline|Celecoxib|400 mg BID given for 7 days before surgery
573369|NCT00582660|P2|Participant Flow|Placebo|1 tablet BID given for 7 days before surgery
573370|NCT00582660|P1|Participant Flow|Celecoxib|400 mg BID given for 7 days before surgery
573371|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
573372|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
573373|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
573374|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
573375|NCT00582660|E2|Reported Event|Placebo|1 tablet BID given for 7 days before surgery
573376|NCT00582660|E1|Reported Event|Celecoxib|400 mg BID given for 7 days before surgery
573377|NCT00582608|B1|Baseline|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
573378|NCT00582608|P1|Participant Flow|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
573379|NCT00582608|O1|Outcome|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
573380|NCT00582608|E1|Reported Event|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
573381|NCT00582556|B4|Baseline|Total|Total of all reporting groups
573382|NCT00582556|B3|Baseline|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
573383|NCT00582556|B2|Baseline|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
573384|NCT00582556|B1|Baseline|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
573385|NCT00582556|P3|Participant Flow|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
573386|NCT00582556|P2|Participant Flow|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
573387|NCT00582556|P1|Participant Flow|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
573388|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
573389|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
573437|NCT00582426|B3|Baseline|Total|Total of all reporting groups
573390|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|Gonadotropin releasing hormone (GnRH) analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
573391|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
573392|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
573393|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
573394|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
573395|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
573396|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
573397|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
573398|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
573399|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
573400|NCT00582556|E3|Reported Event|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
573401|NCT00582556|E2|Reported Event|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
573402|NCT00582556|E1|Reported Event|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
573403|NCT00582517|B3|Baseline|Total|Total of all reporting groups
573404|NCT00582517|B2|Baseline|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
573405|NCT00582517|B1|Baseline|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
573406|NCT00582517|P2|Participant Flow|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
573407|NCT00582517|P1|Participant Flow|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
573408|NCT00582517|O2|Outcome|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
573409|NCT00582517|O1|Outcome|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
573410|NCT00582517|E2|Reported Event|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
573411|NCT00582517|E1|Reported Event|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
573412|NCT00582491|B3|Baseline|Total|Total of all reporting groups
573413|NCT00582491|B2|Baseline|Placebo|Participants received a single oral placebo every morning for 16 days
573414|NCT00582491|B1|Baseline|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573415|NCT00582491|P2|Participant Flow|Placebo|Placebo orally everyday for 16 days
573416|NCT00582491|P1|Participant Flow|Modafinil 400mg|Modafinil 400mg orally everyday for 16 days
573417|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573418|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573419|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573420|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573421|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573422|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573423|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573424|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573425|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573426|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573427|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573428|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573429|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573430|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573431|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573432|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573433|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
573434|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573435|NCT00582491|E2|Reported Event|Placebo|Participants received a single oral placebo every morning for 16 days
573436|NCT00582491|E1|Reported Event|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
573443|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573444|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573445|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573446|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573447|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573448|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573449|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573450|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573451|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573452|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573453|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573454|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573455|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573456|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573457|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573458|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573459|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573460|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573461|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573462|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
573463|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
573464|NCT00582426|E2|Reported Event|Standard Treatment|
573465|NCT00582426|E1|Reported Event|Octreotide LAR|
573466|NCT00582400|B1|Baseline|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
573467|NCT00582400|P1|Participant Flow|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
573468|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
573469|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
573470|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
573471|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
573472|NCT00582400|E1|Reported Event|Arsenic Trioxide (Trisenox)|"arsenic trioxide: Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.~The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution."
573473|NCT00582361|B3|Baseline|Total|Total of all reporting groups
573474|NCT00582361|B2|Baseline|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
573475|NCT00582361|B1|Baseline|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
573476|NCT00582361|P2|Participant Flow|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
573477|NCT00582361|P1|Participant Flow|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
573478|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
574039|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
573479|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
573480|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
573481|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
573482|NCT00582361|E2|Reported Event|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
573483|NCT00582361|E1|Reported Event|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
573484|NCT00582309|B4|Baseline|Total|Total of all reporting groups
573485|NCT00582309|B3|Baseline|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
573486|NCT00582309|B2|Baseline|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
573487|NCT00582309|B1|Baseline|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
573488|NCT00582309|P3|Participant Flow|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
573489|NCT00582309|P2|Participant Flow|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
573490|NCT00582309|P1|Participant Flow|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
573491|NCT00582309|O3|Outcome|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
573492|NCT00582309|O2|Outcome|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
573493|NCT00582309|O1|Outcome|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
573494|NCT00582309|E3|Reported Event|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
573495|NCT00582309|E2|Reported Event|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
573496|NCT00582309|E1|Reported Event|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
573497|NCT00582205|B1|Baseline|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
573498|NCT00582205|P1|Participant Flow|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
573499|NCT00582205|O1|Outcome|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
573500|NCT00582205|O1|Outcome|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
573501|NCT00582205|E1|Reported Event|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
573502|NCT00582114|B3|Baseline|Total|Total of all reporting groups
573503|NCT00582114|B2|Baseline|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573504|NCT00582114|B1|Baseline|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573505|NCT00582114|P2|Participant Flow|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
574040|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
573506|NCT00582114|P1|Participant Flow|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573507|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573508|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573509|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573510|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573511|NCT00582114|E2|Reported Event|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573512|NCT00582114|E1|Reported Event|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
573513|NCT00582075|B1|Baseline|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
573514|NCT00582075|P1|Participant Flow|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
573515|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
573516|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
573517|NCT00582075|E1|Reported Event|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
573518|NCT00582036|B3|Baseline|Total|Total of all reporting groups
573519|NCT00582036|B2|Baseline|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
573520|NCT00582036|B1|Baseline|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
573521|NCT00582036|P2|Participant Flow|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
573522|NCT00582036|P1|Participant Flow|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
573523|NCT00582036|O2|Outcome|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
573524|NCT00582036|O1|Outcome|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
573525|NCT00582036|E2|Reported Event|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
574041|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
573526|NCT00582036|E1|Reported Event|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
573527|NCT00582010|B3|Baseline|Total|Total of all reporting groups
573528|NCT00582010|B2|Baseline|Placebo (Nitrogen Gas)|80 ppm was administered by inhalation for the duration of surgery
573529|NCT00582010|B1|Baseline|Inhaled Nitric Oxide|80 ppm was administered by inhalation for the duration of surgery
573530|NCT00582010|P2|Participant Flow|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
573531|NCT00582010|P1|Participant Flow|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
573532|NCT00582010|O2|Outcome|Placebo|
573533|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573534|NCT00582010|O2|Outcome|Placebo|
573535|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573536|NCT00582010|O2|Outcome|Placebo|
573537|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573538|NCT00582010|O2|Outcome|Placebo|
573539|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573540|NCT00582010|O2|Outcome|Placebo|
573541|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573542|NCT00582010|O2|Outcome|Placebo|
573543|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573544|NCT00582010|O2|Outcome|Placebo|
573545|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573546|NCT00582010|O2|Outcome|Placebo|
573547|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573548|NCT00582010|O2|Outcome|Placebo|
573549|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
573550|NCT00582010|E2|Reported Event|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
573551|NCT00582010|E1|Reported Event|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
573552|NCT00581971|B1|Baseline|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
573553|NCT00581971|P1|Participant Flow|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.
573554|NCT00581971|O1|Outcome|Recurrence|
573555|NCT00581971|O1|Outcome|Acute Toxicity|Participants that experienced Grade 3 or higher toxicity factors.
573556|NCT00581971|E1|Reported Event|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
573557|NCT00581945|B3|Baseline|Total|Total of all reporting groups
573558|NCT00581945|B2|Baseline|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573559|NCT00581945|B1|Baseline|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573560|NCT00581945|P2|Participant Flow|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573561|NCT00581945|P1|Participant Flow|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573562|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573563|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573564|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573565|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573566|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573567|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573568|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573569|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573570|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573571|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573572|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573573|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573574|NCT00581945|E2|Reported Event|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
573575|NCT00581945|E1|Reported Event|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
573576|NCT00581919|B1|Baseline|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
573577|NCT00581919|P1|Participant Flow|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
573578|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
573579|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
573580|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bort, Dex, and Dox with ALCAR: Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
573581|NCT00581919|E1|Reported Event|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
573582|NCT00581867|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and insulin first.
573583|NCT00581867|P2|Participant Flow|Intranasal Insulin First, Then Placebo|Participants in this group were randomized to receive Intranasal Insulin at the first fMRI visit and then received Placebo at the second fMRI visit.
573584|NCT00581867|P1|Participant Flow|Placebo First, Then Intranasal Insulin|Participants in this group were randomized to receive placebo at the first fMRI visit and then received Intranasal Insulin at the second fMRI visit.
573585|NCT00581867|O2|Outcome|Placebo|
573586|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
573587|NCT00581867|O2|Outcome|Placebo|
573588|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
573589|NCT00581867|E2|Reported Event|Placebo|Placebo was administered in either first or second intervention period.
573590|NCT00581867|E1|Reported Event|Intranasal Insulin Aspart|Intranasal Insulin was administered in either first or second intervention period.
573591|NCT00581854|B1|Baseline|Group 1|SAEs during induction therapy
573592|NCT00581854|P1|Participant Flow|Rituximab|Single Arm Maintenance rituximab following induction chemoimmunotherapy
573593|NCT00581854|O1|Outcome|Group 1|All subjects received R-HyperCVAD induction therapy.
573594|NCT00581854|E1|Reported Event|Group 1|SAEs during induction therapy
573595|NCT00581828|B1|Baseline|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
573596|NCT00581828|P1|Participant Flow|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
573597|NCT00581828|O1|Outcome|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
573598|NCT00581828|E1|Reported Event|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
573599|NCT00581776|B1|Baseline|VCR-CVAD With Rituximab Maintenance|
573600|NCT00581776|P1|Participant Flow|VCR-CVAD With Rituximab Maintenance|
573601|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
573602|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
573603|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
573604|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
573605|NCT00581776|E1|Reported Event|VCR-CVAD With Rituximab Maintenance|
573606|NCT00581581|B3|Baseline|Total|Total of all reporting groups
573607|NCT00581581|B2|Baseline|Standard Care|Randomized to standard care (original RCT)
573608|NCT00581581|B1|Baseline|Therapeutic Hypothermia|Randomized to cooling (original RCT)
573609|NCT00581581|P2|Participant Flow|Standard Care|Randomized to standard care (original RCT)
573610|NCT00581581|P1|Participant Flow|Therapeutic Hypothermia|Randomized to cooling (original RCT)
573611|NCT00581581|O2|Outcome|Standard Care|Randomized to standard care (original RCT)
573612|NCT00581581|O1|Outcome|Therapeutic Hypothermia|Randomized to cooling (original RCT)
573613|NCT00581581|E2|Reported Event|Standard Care|Randomized to standard care (original RCT)
573614|NCT00581581|E1|Reported Event|Therapeutic Hypothermia|Randomized to cooling (original RCT)
573615|NCT00581555|B3|Baseline|Total|Total of all reporting groups
573616|NCT00581555|B2|Baseline|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573617|NCT00581555|B1|Baseline|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
574042|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
573618|NCT00581555|P2|Participant Flow|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573619|NCT00581555|P1|Participant Flow|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573620|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573621|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573622|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573623|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573624|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573625|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573626|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573627|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573628|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573629|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573630|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573631|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573632|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573633|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573634|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573635|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573636|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573637|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573638|NCT00581555|E2|Reported Event|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
573639|NCT00581555|E1|Reported Event|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
573640|NCT00581542|B3|Baseline|Total|Total of all reporting groups
573641|NCT00581542|B2|Baseline|Moxifloxacin Ophthalmic Solution|randomization to topical moxifloxacin
573642|NCT00581542|B1|Baseline|Polytrim Ophthalmic Solution|randomization to topical polytrim
573643|NCT00581542|P2|Participant Flow|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
573644|NCT00581542|P1|Participant Flow|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
573645|NCT00581542|O2|Outcome|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
573646|NCT00581542|O1|Outcome|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
573647|NCT00581542|O2|Outcome|Moxifloxacin|
573648|NCT00581542|O1|Outcome|Polytrim Arm|
573649|NCT00581542|E2|Reported Event|Polytrim Treatment Group|
573650|NCT00581542|E1|Reported Event|Moxifloxacin Treatment Group|
573651|NCT00581529|B1|Baseline|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
573652|NCT00581529|P1|Participant Flow|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
573653|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
573654|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
573655|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
573656|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
573657|NCT00581529|E1|Reported Event|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
573658|NCT00581399|B3|Baseline|Total|Total of all reporting groups
573659|NCT00581399|B2|Baseline|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
573660|NCT00581399|B1|Baseline|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
573661|NCT00581399|P2|Participant Flow|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
573662|NCT00581399|P1|Participant Flow|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
573663|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
573664|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
573665|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
573666|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
573667|NCT00581399|E2|Reported Event|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
573668|NCT00581399|E1|Reported Event|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
573669|NCT00581386|B4|Baseline|Total|Total of all reporting groups
573670|NCT00581386|B3|Baseline|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573671|NCT00581386|B2|Baseline|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573672|NCT00581386|B1|Baseline|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573673|NCT00581386|P3|Participant Flow|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573674|NCT00581386|P2|Participant Flow|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573675|NCT00581386|P1|Participant Flow|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573676|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573677|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573678|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573679|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573680|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573681|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573682|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573683|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573684|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573685|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573686|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573687|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573688|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573689|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573690|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573691|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573692|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573693|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573694|NCT00581386|E3|Reported Event|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
573695|NCT00581386|E2|Reported Event|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
573696|NCT00581386|E1|Reported Event|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
573697|NCT00581360|B1|Baseline|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
573698|NCT00581360|P1|Participant Flow|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
574043|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
573699|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
573700|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
573701|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
573702|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
573703|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
573704|NCT00581360|E1|Reported Event|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
573705|NCT00581347|B3|Baseline|Total|Total of all reporting groups
573706|NCT00581347|B2|Baseline|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
573707|NCT00581347|B1|Baseline|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
573708|NCT00581347|P2|Participant Flow|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
573709|NCT00581347|P1|Participant Flow|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
573710|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
573711|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
573712|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
573713|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
573714|NCT00581347|E2|Reported Event|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
573715|NCT00581347|E1|Reported Event|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
573716|NCT00581308|B1|Baseline|PAS Subjects|Subjects with occluder in place upon leaving cath lab
573717|NCT00581308|P1|Participant Flow|PAS Subjects|Subjects with occluder in place upon leaving cath lab
573718|NCT00581308|O1|Outcome|GORE® HELEX® Septal Occluder|Subjects who received a GORE® HELEX® Septal Occluder
574044|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
573721|NCT00581308|O1|Outcome|Clinical Success at 12 Months|Subjects with occluder in place upon leaving cath lab
573722|NCT00581308|E1|Reported Event|PAS Subjects|Subjects with occluder in place upon leaving cath lab
573723|NCT00581256|B3|Baseline|Total|Total of all reporting groups
573724|NCT00581256|B2|Baseline|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
573725|NCT00581256|B1|Baseline|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
573726|NCT00581256|P2|Participant Flow|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
573727|NCT00581256|P1|Participant Flow|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
573728|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
573729|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
573730|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
573731|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
573732|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
573733|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
573734|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
573735|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
573736|NCT00581256|E2|Reported Event|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
573771|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
574045|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
574046|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
573737|NCT00581256|E1|Reported Event|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
573738|NCT00581230|B1|Baseline|Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP|First, laryngoscopy was preformed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Positioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™. Second, the Rapid Airway Management Positioner (RAMP) was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, the second time with RAMP, and the laryngeal view was recorded.
573739|NCT00581230|P1|Participant Flow|Entire Study|All the patients first underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope without RAMP. Second, all patients underwent laryngoscopy with RAMP--the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
573740|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|The Cormack Lehane grade glottic view obtained during laryngoscopy with inflated RAMP pillow. In all participants, laryngoscopy with the Rapid Airway Management Positioner (RAMP) was performed second (after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
573741|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|The Cormack Lehane grade view obtained with laryngoscopy when there was no RAMP pillow. In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
573742|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|In this crossover study, all participants then received laryngoscopy with the Rapid Airway Management Positioner (RAMP) (immediately after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
573743|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
573744|NCT00581230|E1|Reported Event|Entire Study|This is a crossover study, all the patients 1st underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope. After this, the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
573745|NCT00581113|B3|Baseline|Total|Total of all reporting groups
573746|NCT00581113|B2|Baseline|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
573747|NCT00581113|B1|Baseline|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
573748|NCT00581113|P2|Participant Flow|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
573749|NCT00581113|P1|Participant Flow|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
573750|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
573751|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
573752|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
573753|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
573754|NCT00581113|E2|Reported Event|Standard Whole Brain RT|Standard Whole Brain RT
573755|NCT00581113|E1|Reported Event|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
573756|NCT00581100|B3|Baseline|Total|Total of all reporting groups
573757|NCT00581100|B2|Baseline|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573758|NCT00581100|B1|Baseline|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573759|NCT00581100|P2|Participant Flow|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573760|NCT00581100|P1|Participant Flow|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573761|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573762|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573763|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573764|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573765|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573766|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573767|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573768|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573769|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573770|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573772|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573773|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573774|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573775|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573776|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573777|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573778|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573779|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573780|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573781|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573782|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573783|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573784|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573785|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573786|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573787|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573788|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573789|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573790|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573791|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573792|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573793|NCT00581100|E2|Reported Event|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
573794|NCT00581100|E1|Reported Event|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
573795|NCT00581061|B1|Baseline|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
573796|NCT00581061|P1|Participant Flow|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
573797|NCT00581061|O1|Outcome|Vesicare|Number of people who experienced side effects while taking Vesicare, per study protocol. These are known side effects indicated on the drug label that occur to subjects on this medication.
573798|NCT00581061|O1|Outcome|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
573799|NCT00581061|O1|Outcome|Vesicare|Number of days it takes for subjects to achieve pad free urinary continence
573800|NCT00581061|E1|Reported Event|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
573801|NCT00581048|B1|Baseline|Natural Source d-α-tocopheryl Acetate|"1500 units daily for 16 weeks~Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks"
573802|NCT00581048|P1|Participant Flow|Natural Source d-α-tocopheryl Acetate|"1500 units daily for 16 weeks~Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks"
573803|NCT00581048|O2|Outcome|After Treatment|
573804|NCT00581048|O1|Outcome|Before Treatment, Baseline|
573805|NCT00581048|O2|Outcome|After Treatment|
573806|NCT00581048|O1|Outcome|Before Treatment, Baseline|
573807|NCT00581048|O2|Outcome|After Treatment|
573808|NCT00581048|O1|Outcome|Before Treatment, Baseline|
573809|NCT00581048|O2|Outcome|After Treatment|
573810|NCT00581048|O1|Outcome|Before Treatment, Baseline|
573811|NCT00581048|E1|Reported Event|Natural Source d-α-tocopheryl Acetate|"1500 units daily for 16 weeks~Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks"
573812|NCT00580983|B1|Baseline|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
573833|NCT00580866|B2|Baseline|PT Only Group|
573834|NCT00580866|B1|Baseline|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
573835|NCT00580866|P2|Participant Flow|PT Only Group|
573836|NCT00580866|P1|Participant Flow|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
573813|NCT00580983|P1|Participant Flow|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
573814|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
573815|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
573816|NCT00580983|E1|Reported Event|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
573817|NCT00580970|B3|Baseline|Total|Total of all reporting groups
573818|NCT00580970|B2|Baseline|Supportive Care (Lovastatin) (Ineligible)|The 20 subjects started Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy). The subjects were ineligible because they did not complete 6 months of Lovastatin.
573819|NCT00580970|B1|Baseline|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
573820|NCT00580970|P1|Participant Flow|Supportive Care (Lovastatin)|"Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.~73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects."
573821|NCT00580970|O1|Outcome|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
573822|NCT00580970|E1|Reported Event|Supportive Care (Lovastatin)|"Subjects who started treatment on Lovastatin on the first day of radiation therapy (external beam radiation therapy (EBRT) alone, brachytherapy alone, or EBRT followed by brachytherapy).~73 subjects enrolled in the study, 72 started Lovastatin treatment, 20 subjects were ineligible for analysis, and a total of 53 subjects evaluable for analysis. 72 subjects started treatment and were at risk for Adverse Events (AEs) and Serious Adverse Events(SAEs)."
573823|NCT00580957|B3|Baseline|Total|Total of all reporting groups
573824|NCT00580957|B2|Baseline|Intact Then Blocked|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
573825|NCT00580957|B1|Baseline|Blocked Then Intact|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
573826|NCT00580957|P2|Participant Flow|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
573827|NCT00580957|P1|Participant Flow|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
573828|NCT00580957|O2|Outcome|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
573829|NCT00580957|O1|Outcome|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
573830|NCT00580957|E2|Reported Event|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
573831|NCT00580957|E1|Reported Event|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
573832|NCT00580866|B3|Baseline|Total|Total of all reporting groups
573838|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
573839|NCT00580866|O2|Outcome|PT Only Group|
573840|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
573841|NCT00580866|E2|Reported Event|PT Only Group|
573842|NCT00580866|E1|Reported Event|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
573843|NCT00580853|B4|Baseline|Total|Total of all reporting groups
573844|NCT00580853|B3|Baseline|Placebo|"Placebo Control~Placebo: Placebo"
573845|NCT00580853|B2|Baseline|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
573846|NCT00580853|B1|Baseline|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
573847|NCT00580853|P3|Participant Flow|Placebo|"Placebo Control~Placebo: Placebo"
573848|NCT00580853|P2|Participant Flow|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
573849|NCT00580853|P1|Participant Flow|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
573850|NCT00580853|O3|Outcome|Placebo|"Placebo Control~Placebo: Placebo"
573851|NCT00580853|O2|Outcome|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
573852|NCT00580853|O1|Outcome|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
573853|NCT00580853|O3|Outcome|Placebo|"Placebo Control~Placebo: Placebo"
573854|NCT00580853|O2|Outcome|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
573855|NCT00580853|O1|Outcome|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
573856|NCT00580853|E3|Reported Event|Placebo|"Placebo Control~Placebo: Placebo"
573857|NCT00580853|E2|Reported Event|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
573858|NCT00580853|E1|Reported Event|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
573859|NCT00580840|B1|Baseline|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573860|NCT00580840|P4|Participant Flow|PLO + MTX|Placebo (PTO) + Methotrexate (MTX)
573861|NCT00580840|P3|Participant Flow|CZP 200 mg and PLO + MTX|Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX)
573862|NCT00580840|P2|Participant Flow|CZP 400 mg and PLO + MTX|Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX)
573863|NCT00580840|P1|Participant Flow|Overall|Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period.
573864|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573865|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573866|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573867|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573868|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573869|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573870|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573871|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573872|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573873|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573874|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573875|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573876|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573877|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573878|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573879|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573880|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573881|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573882|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573883|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573884|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573885|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573886|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573887|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573888|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573889|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573890|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573891|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573892|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573893|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573894|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573895|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573896|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573897|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573898|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573899|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573900|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573901|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573902|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573903|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573904|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573905|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573906|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573907|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
574047|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
574048|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
573908|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573909|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573910|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573911|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573912|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573913|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573914|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573915|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573916|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573917|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573918|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573919|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573920|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573921|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573922|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573923|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573924|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573925|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573926|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573927|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573928|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573929|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573930|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573931|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573932|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573933|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573934|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573935|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573936|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573937|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573938|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573939|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573940|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
574049|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
573941|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573942|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573943|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573944|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573945|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573946|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573947|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573948|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573949|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573950|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573951|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573952|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573953|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573954|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573955|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573956|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573957|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573958|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573959|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573960|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573961|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573962|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573963|NCT00580840|E4|Reported Event|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
573964|NCT00580840|E3|Reported Event|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
573965|NCT00580840|E2|Reported Event|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
573966|NCT00580840|E1|Reported Event|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
573967|NCT00580801|B4|Baseline|Total|Total of all reporting groups
573968|NCT00580801|B3|Baseline|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573969|NCT00580801|B2|Baseline|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573970|NCT00580801|B1|Baseline|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573971|NCT00580801|P3|Participant Flow|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573972|NCT00580801|P2|Participant Flow|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573973|NCT00580801|P1|Participant Flow|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573974|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573975|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573976|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573977|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573978|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573979|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573980|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573981|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573982|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573983|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573984|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573985|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573986|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573987|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573988|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573989|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573990|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573991|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573992|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573993|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573994|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
574050|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
573995|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573996|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573997|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
573998|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
573999|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
574000|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
574001|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
574002|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
574003|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
574004|NCT00580801|E3|Reported Event|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
574005|NCT00580801|E2|Reported Event|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
574006|NCT00580801|E1|Reported Event|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
574007|NCT00580788|B5|Baseline|Total|Total of all reporting groups
574008|NCT00580788|B4|Baseline|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574009|NCT00580788|B3|Baseline|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574010|NCT00580788|B2|Baseline|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
574011|NCT00580788|B1|Baseline|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574012|NCT00580788|P4|Participant Flow|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
574013|NCT00580788|P3|Participant Flow|Group 3|PTHrP (1-36) 5 pmol/kg/hr
574014|NCT00580788|P2|Participant Flow|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
574015|NCT00580788|P1|Participant Flow|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
574016|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
574017|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
574018|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
574019|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574020|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574021|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574022|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
574023|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574024|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574025|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574026|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
574027|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574028|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574029|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574030|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
574031|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574032|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574033|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574034|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
574035|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574036|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574037|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574051|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
574052|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
574053|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
574054|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
574055|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574056|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
574057|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
574058|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
574059|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574060|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574061|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574062|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
574063|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574064|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
574065|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
574066|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
574067|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574068|NCT00580788|E4|Reported Event|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
574069|NCT00580788|E3|Reported Event|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
574070|NCT00580788|E2|Reported Event|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
574071|NCT00580788|E1|Reported Event|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
574072|NCT00580723|B1|Baseline|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
574073|NCT00580723|P1|Participant Flow|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
574074|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
574075|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
574076|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
574077|NCT00580723|E1|Reported Event|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
574078|NCT00580671|B4|Baseline|Total|Total of all reporting groups
574079|NCT00580671|B3|Baseline|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
574080|NCT00580671|B2|Baseline|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
574081|NCT00580671|B1|Baseline|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
574082|NCT00580671|P3|Participant Flow|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
574083|NCT00580671|P2|Participant Flow|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
574084|NCT00580671|P1|Participant Flow|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/ Cognitive Behavior Therapy (CBT) + Contingency Management (CM) / Behavioral Parent Training (BPT)
574085|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
574086|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
574087|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
574088|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
574089|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
574090|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
574091|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
574092|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
574093|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
574094|NCT00580671|E3|Reported Event|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
574095|NCT00580671|E2|Reported Event|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
574096|NCT00580671|E1|Reported Event|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
574097|NCT00580645|B4|Baseline|Total|Total of all reporting groups
574098|NCT00580645|B3|Baseline|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574099|NCT00580645|B2|Baseline|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574100|NCT00580645|B1|Baseline|Placebo|"Placebo controlled~placebo: placebo"
574101|NCT00580645|P3|Participant Flow|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574102|NCT00580645|P2|Participant Flow|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574103|NCT00580645|P1|Participant Flow|Placebo|"Placebo controlled~placebo: placebo"
574104|NCT00580645|O3|Outcome|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574105|NCT00580645|O2|Outcome|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574106|NCT00580645|O1|Outcome|Placebo|"Placebo controlled~placebo: placebo"
574107|NCT00580645|O3|Outcome|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574681|NCT00578929|P4|Participant Flow|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
574108|NCT00580645|O2|Outcome|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574109|NCT00580645|O1|Outcome|Placebo|"Placebo controlled~placebo: placebo"
574110|NCT00580645|E3|Reported Event|2 mg/Day Varenicline|2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574111|NCT00580645|E2|Reported Event|1 mg/Day Varenicline|1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
574112|NCT00580645|E1|Reported Event|Placebo|"Placebo controlled~placebo: placebo"
574113|NCT00580606|B3|Baseline|Total|Total of all reporting groups
574114|NCT00580606|B2|Baseline|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
574115|NCT00580606|B1|Baseline|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
574116|NCT00580606|P2|Participant Flow|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
574117|NCT00580606|P1|Participant Flow|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
574118|NCT00580606|O2|Outcome|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
574119|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
574120|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
574191|NCT00580073|E1|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
574121|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
574122|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
574123|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
574124|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
574125|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
574126|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
574127|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
574128|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
574129|NCT00580606|E5|Reported Event|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
574130|NCT00580606|E4|Reported Event|Low Dose Peanut SLIT (Double Blind to Open Label)|After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
574131|NCT00580606|E3|Reported Event|High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
574192|NCT00580047|B4|Baseline|Total|Total of all reporting groups
574193|NCT00580047|B3|Baseline|Placebo Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D"
574132|NCT00580606|E2|Reported Event|Placebo Before Week 44 OFC (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
574133|NCT00580606|E1|Reported Event|Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
574134|NCT00580502|B1|Baseline|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
574135|NCT00580502|P1|Participant Flow|Lap-Band|"Low BMI patients who will go through Lap-band surgery.~LAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB"
574136|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
574137|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
574138|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
574139|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
574140|NCT00580502|E1|Reported Event|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
574141|NCT00580398|B3|Baseline|Total|Total of all reporting groups
574142|NCT00580398|B2|Baseline|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
574143|NCT00580398|B1|Baseline|Control|Usual care included physician advice to quit smoking.
574144|NCT00580398|P2|Participant Flow|Intervention|Intervention participants were provided with a 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We had proposed to offer 7 counseling sessions but were flexible in offering additional sessions when needed. The counseling was delivered by a certified Tobacco Treatment Counselor using motivational interviewing (MI) techniques.
574145|NCT00580398|P1|Participant Flow|Control|Usual care included physician advice to quit smoking.
574146|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
574147|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
574148|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
574149|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
574150|NCT00580398|E2|Reported Event|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
574151|NCT00580398|E1|Reported Event|Control|Usual care included physician advice to quit smoking.
574152|NCT00580372|B1|Baseline|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
574153|NCT00580372|P1|Participant Flow|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
574154|NCT00580372|O1|Outcome|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
574194|NCT00580047|B2|Baseline|Oral Bisphosphonate Post Tranpslantation|"Alendronate 70mg~Alendronate: 70mg weekly"
575764|NCT00577135|O2|Outcome|Continuous Infusion|
574155|NCT00580372|E1|Reported Event|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
574156|NCT00580333|B1|Baseline|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
574157|NCT00580333|P1|Participant Flow|Cisplatin/Avastin|"cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
574158|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
574159|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
574160|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
574161|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
574195|NCT00580047|B1|Baseline|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually"
574196|NCT00580047|P3|Participant Flow|Placebo Group Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D"
574197|NCT00580047|P2|Participant Flow|Oral Bisphosphonate Post Transplantation|"Alendronate 70mg~Alendronate: 70mg weekly"
574198|NCT00580047|P1|Participant Flow|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually"
574199|NCT00580047|O3|Outcome|Placebo Group Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D~6.2% increase in spine bone density"
575765|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
574162|NCT00580333|E1|Reported Event|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
574163|NCT00580294|B1|Baseline|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
574164|NCT00580294|P1|Participant Flow|Oxymorphone|participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
574165|NCT00580294|O1|Outcome|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
574166|NCT00580294|E1|Reported Event|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
574167|NCT00580229|B1|Baseline|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
574168|NCT00580229|P1|Participant Flow|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
574169|NCT00580229|O1|Outcome|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
574170|NCT00580229|E1|Reported Event|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
574171|NCT00580151|B3|Baseline|Total|Total of all reporting groups
574172|NCT00580151|B2|Baseline|Control Group|placebo : 1 dose every 6 hours
574173|NCT00580151|B1|Baseline|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
574174|NCT00580151|P2|Participant Flow|Control Group|placebo : 1 dose every 6 hours
574175|NCT00580151|P1|Participant Flow|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
574176|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
574177|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
574178|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
574179|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
574180|NCT00580151|E2|Reported Event|Control Group|placebo : 1 dose every 6 hours
574181|NCT00580151|E1|Reported Event|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
574182|NCT00580138|B1|Baseline|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
574183|NCT00580138|P1|Participant Flow|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
574184|NCT00580138|O1|Outcome|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
574185|NCT00580138|E1|Reported Event|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
574186|NCT00580073|B1|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
574187|NCT00580073|P1|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU (5-fluorouracil) Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
574188|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
574189|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
574190|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
575766|NCT00577135|O4|Outcome|High Intensification|
574200|NCT00580047|O2|Outcome|Oral Bisphosphonate Post Transplantation|"Alendronate 70mg~Alendronate: 70mg weekly~5.8% increase in spine bone density"
574201|NCT00580047|O1|Outcome|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually~7.9% increase in spine bone density"
574202|NCT00580047|O3|Outcome|Placebo Group Post Transplantation|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D~8% increase"
574203|NCT00580047|O2|Outcome|Oral Bisphosphonate Post Transplantation|"Alendronate 70mg~Alendronate: 70mg weekly~8% increase"
574204|NCT00580047|O1|Outcome|Intravenous Bisphosphonate Post Transplantation|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually~8% increase"
574205|NCT00580047|E3|Reported Event|Placebo After Transplant|"Calcium 1200mg Vitamin D 800IU~calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D"
574206|NCT00580047|E2|Reported Event|Oral Bisphosphonate After Transplant|"Alendronate 70mg~Alendronate: 70mg weekly"
574207|NCT00580047|E1|Reported Event|Intravenous Bisphosphonate After Tranpslant|"Zoledronic Acid 4mg~Zoledronic Acid: 4mg IV Annually"
574208|NCT00580034|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
574209|NCT00580034|P2|Participant Flow|Donor Apheresis|"Donor must be a sibling, half sibling, parent, child or first cousin familial relationship and 3-5/6 Human Leukocyte Antigen matched related to subject. They must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following:~Adequate cardiac function by history and physical examination~bilirubin and hepatic transaminases < 2.5 x upper limit of normal~normal hematologic parameters Females should have a negative serum pregnancy test."
574210|NCT00580034|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously(dose will be rounded to the nearest whole vial size and may be divided into bid dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
574211|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
574212|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
574213|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
574241|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
574242|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
574243|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
574244|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
575767|NCT00577135|O3|Outcome|Low Intensification|
574214|NCT00580034|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneously or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
574215|NCT00579982|B1|Baseline|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574216|NCT00579982|P1|Participant Flow|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574217|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574218|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574219|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574220|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574221|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574222|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574223|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574224|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574225|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574226|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574227|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574228|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574229|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574230|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574231|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574232|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574233|NCT00579982|E1|Reported Event|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
574234|NCT00579826|B3|Baseline|Total|Total of all reporting groups
574235|NCT00579826|B2|Baseline|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
574236|NCT00579826|B1|Baseline|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
574237|NCT00579826|P2|Participant Flow|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
574238|NCT00579826|P1|Participant Flow|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
574239|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
574240|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
575768|NCT00577135|O2|Outcome|Continuous Infusion|
574245|NCT00579826|E2|Reported Event|Placebo for 6 Months; Open Label Letrozole 2.5 mg Daily|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
574246|NCT00579826|E1|Reported Event|Letrozole, 2.5 mg Daily for 12 Months|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
574247|NCT00579813|B3|Baseline|Total|Total of all reporting groups
574248|NCT00579813|B2|Baseline|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
574249|NCT00579813|B1|Baseline|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
574250|NCT00579813|P2|Participant Flow|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
574251|NCT00579813|P1|Participant Flow|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
574252|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
574253|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
574254|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
574255|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
574256|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
574257|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
574258|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
574259|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
574260|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
574261|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
574262|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
574263|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
574264|NCT00579813|E2|Reported Event|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
574265|NCT00579813|E1|Reported Event|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
574266|NCT00579670|B6|Baseline|Total|Total of all reporting groups
574267|NCT00579670|B5|Baseline|Ziprasidone Unknown|Details are unknown.
574268|NCT00579670|B4|Baseline|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574269|NCT00579670|B3|Baseline|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574270|NCT00579670|B2|Baseline|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574271|NCT00579670|B1|Baseline|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574272|NCT00579670|P5|Participant Flow|Ziprasidone Unknown|Details are unknown.
574273|NCT00579670|P4|Participant Flow|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574274|NCT00579670|P3|Participant Flow|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574275|NCT00579670|P2|Participant Flow|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574276|NCT00579670|P1|Participant Flow|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574277|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574278|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574279|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574280|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574281|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574282|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574283|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574284|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574285|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574286|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574287|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574288|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574289|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574290|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574291|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574292|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574293|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574294|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574295|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574296|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574297|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574298|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574299|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574300|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574301|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574302|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574303|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574304|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574305|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574306|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574307|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574308|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574309|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574310|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574311|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574312|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574313|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574314|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574315|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574316|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574317|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574318|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574319|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574320|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574321|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574322|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574323|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574324|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574325|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574326|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574327|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574328|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574329|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574330|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574331|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574332|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574333|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574334|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574335|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574336|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574337|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574338|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574339|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574340|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574341|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574342|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574343|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574344|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574345|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574346|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574347|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574348|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574349|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574350|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574351|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574352|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574353|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574354|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574355|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574356|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574357|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
574358|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
574359|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
574360|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
574361|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574362|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574363|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574364|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574365|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574366|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574367|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574368|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574369|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574370|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574371|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574372|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574373|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574374|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574375|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574376|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574377|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574378|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574379|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574380|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574381|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574382|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574383|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574384|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574385|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574386|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574387|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574388|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574389|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574390|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574391|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574392|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574393|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574394|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574395|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574396|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574397|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574398|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574399|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574400|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574401|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574402|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574403|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574404|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574405|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574406|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574407|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574408|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574409|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574410|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574411|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574412|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574413|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574414|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574415|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574416|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574417|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574418|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574419|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574420|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574421|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574422|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574423|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574424|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574425|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574426|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574427|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574428|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574429|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574430|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574431|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574432|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574433|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574434|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574435|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574436|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574437|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574438|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574439|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574440|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574441|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574442|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574443|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574444|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574445|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574446|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574447|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574448|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574449|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574450|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574451|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574452|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574453|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574454|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574455|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574456|NCT00579670|O5|Outcome|Ziprasodone Unknown|Details are unknown.
574457|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574458|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574459|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574460|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
574461|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574462|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574463|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574464|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574465|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574466|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574467|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574468|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574469|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574470|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574471|NCT00579670|O1|Outcome|Ziprasidone Total|Ziprasidone all doses received combined.
574472|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
574473|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
574474|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574475|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574476|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
574477|NCT00579670|E10|Reported Event|Above SmPC Ziprasidone > 160 mg|Above SmPC Ziprasidone > 160 mg per day; defined as all participants in FAS population who received at least 1 PO dose above 160 mg per day or any IM dose above 40 mg per day or with an unknown dose or formulation.
574478|NCT00579670|E9|Reported Event|Within SmPC Ziprasidone = 160 mg|Within SmPC Ziprasidone = 160 mg; defined as all participants in the FAS population who had PO doses = 160 mg per day.
574479|NCT00579670|E8|Reported Event|Within SmPC Ziprasidone 120 to < 160 mg|Within SmPC Ziprasidone 120 to < 160 mg; defined as all participants in the FAS population who had PO doses between 120 mg and < 160 mg per day.
574480|NCT00579670|E7|Reported Event|Within SmPC Ziprasidone 80 to < 120 mg|Within SmPC Ziprasidone 80 to < 120 mg; defined as all participants in the FAS population who had PO doses between 80 mg and < 120 mg per day.
574481|NCT00579670|E6|Reported Event|Within SmPC Ziprasidone < 80 mg|Within SmPC < 80 mg per day; defined as all participants in the FAS population who had PO doses up to 80 mg per day and all IM doses up to and including 40 mg per day.
574482|NCT00579670|E5|Reported Event|Ziprasidone Unknown|Details are unknown.
574483|NCT00579670|E4|Reported Event|Ziprasidone >=160 mg|Ziprasidone 160 mg or greater per day.
574484|NCT00579670|E3|Reported Event|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
574485|NCT00579670|E2|Reported Event|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
574486|NCT00579670|E1|Reported Event|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
574487|NCT00579501|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
574488|NCT00579501|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
574489|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
574490|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
574491|NCT00579501|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
574492|NCT00579436|B3|Baseline|Total|Total of all reporting groups
574493|NCT00579436|B2|Baseline|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
574494|NCT00579436|B1|Baseline|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
574495|NCT00579436|P2|Participant Flow|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
574496|NCT00579436|P1|Participant Flow|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
574497|NCT00579436|O2|Outcome|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
574498|NCT00579436|O1|Outcome|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
574499|NCT00579436|O2|Outcome|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
574500|NCT00579436|O1|Outcome|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
574501|NCT00579436|O2|Outcome|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
574502|NCT00579436|O1|Outcome|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
574503|NCT00579436|O2|Outcome|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
574504|NCT00579436|O1|Outcome|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
574505|NCT00579436|E2|Reported Event|Control Group|"placebo (4 non-active capsules daily)~placebo: 4 inert capsules daily by mouth for 12 weeks."
574506|NCT00579436|E1|Reported Event|Fish Oil Group|"4g Lovaza (omega-3 fatty acid) daily.~omega-3 fatty acid: 4g of omega-3 fatty acid daily by mouth for 12 weeks."
574507|NCT00579345|B9|Baseline|Total|Total of all reporting groups
574508|NCT00579345|B8|Baseline|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574509|NCT00579345|B7|Baseline|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574510|NCT00579345|B6|Baseline|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574511|NCT00579345|B5|Baseline|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
574512|NCT00579345|B4|Baseline|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574530|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
574513|NCT00579345|B3|Baseline|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574514|NCT00579345|B2|Baseline|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574515|NCT00579345|B1|Baseline|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574516|NCT00579345|P8|Participant Flow|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574517|NCT00579345|P7|Participant Flow|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574518|NCT00579345|P6|Participant Flow|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574519|NCT00579345|P5|Participant Flow|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
574520|NCT00579345|P4|Participant Flow|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574521|NCT00579345|P3|Participant Flow|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574522|NCT00579345|P2|Participant Flow|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574523|NCT00579345|P1|Participant Flow|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574524|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
574525|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV).
574526|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
574527|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
574528|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574529|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574531|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
574532|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574533|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574534|NCT00579345|O2|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
574535|NCT00579345|O1|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
574536|NCT00579345|O6|Outcome|eTIV_a+PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
574537|NCT00579345|O5|Outcome|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
574538|NCT00579345|O4|Outcome|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
574539|NCT00579345|O3|Outcome|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study.
574540|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)).
574541|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV)).
574542|NCT00579345|O4|Outcome|eTIV_a (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574543|NCT00579345|O3|Outcome|cTIV (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574544|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574545|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574546|NCT00579345|E8|Reported Event|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574547|NCT00579345|E7|Reported Event|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age)were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574548|NCT00579345|E6|Reported Event|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
574549|NCT00579345|E5|Reported Event|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
574550|NCT00579345|E4|Reported Event|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574551|NCT00579345|E3|Reported Event|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574552|NCT00579345|E2|Reported Event|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
574553|NCT00579345|E1|Reported Event|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
574554|NCT00579254|B1|Baseline|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
574555|NCT00579254|P1|Participant Flow|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
574556|NCT00579254|O1|Outcome|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
574557|NCT00579254|E1|Reported Event|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
574558|NCT00579137|B1|Baseline|Single Group|only one group
574559|NCT00579137|P1|Participant Flow|Participants With SCID or Primary Immunodeficiency Disorder|"Participants received an allogeneic stem cell transplant with the following conditioning:~Day 8 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D7 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D6 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D5 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D4 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D3 Anti-CD45 MAb 400ug/kg over 6 hr~D2 Anti-CD45 MAb 400ug/kg over 6 hr~D1 rest~D0 Stem Cell Infusion~Campath dose is weight based: for patients less than 15 kg administer Campath 3 mg; for patients >15 kg to 30 kg administer Campath 5 mg; for patients > 30 kg administer Campath 10 mg. Campath will be dosed and administered as per CAGT SOP.~Anti-CD45 infusion will be administered according to CAGT SOPs."
574560|NCT00579137|O1|Outcome|Single Group|only one group
574561|NCT00579137|O1|Outcome|Single Group|only one group
574562|NCT00579137|O1|Outcome|Single Group|only one group
574563|NCT00579137|O1|Outcome|Single Group|only one group
574564|NCT00579137|E1|Reported Event|Single Group|only one group
574565|NCT00579111|B3|Baseline|Total|Total of all reporting groups
574566|NCT00579111|B2|Baseline|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
574567|NCT00579111|B1|Baseline|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
574568|NCT00579111|P2|Participant Flow|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
574569|NCT00579111|P1|Participant Flow|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
574570|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
574571|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
574572|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
574573|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
574574|NCT00579111|E2|Reported Event|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
574575|NCT00579111|E1|Reported Event|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
574576|NCT00579098|B3|Baseline|Total|Total of all reporting groups
574577|NCT00579098|B2|Baseline|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574578|NCT00579098|B1|Baseline|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574579|NCT00579098|P2|Participant Flow|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574580|NCT00579098|P1|Participant Flow|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574581|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574582|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574583|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574584|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574585|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574586|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574587|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574588|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574589|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574590|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574591|NCT00579098|E2|Reported Event|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
574592|NCT00579098|E1|Reported Event|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
574593|NCT00579059|B3|Baseline|Total|Total of all reporting groups
574594|NCT00579059|B2|Baseline|Maxim® Regular Tibia|Tibia with Modular Polyethylene
574595|NCT00579059|B1|Baseline|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
574596|NCT00579059|P2|Participant Flow|Maxim® Regular Tibia|Tibia with Modular Polyethylene
574597|NCT00579059|P1|Participant Flow|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
574598|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
574599|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
574600|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
574601|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
574602|NCT00579059|E2|Reported Event|Maxim® Regular Tibia|Tibia with Modular Polyethylene
574603|NCT00579059|E1|Reported Event|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
574604|NCT00578968|B4|Baseline|Total|Total of all reporting groups
574605|NCT00578968|B3|Baseline|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
574606|NCT00578968|B2|Baseline|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574607|NCT00578968|B1|Baseline|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574608|NCT00578968|P3|Participant Flow|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
574609|NCT00578968|P2|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574610|NCT00578968|P1|Participant Flow|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574611|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574612|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574613|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574614|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574615|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574616|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574617|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574618|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574619|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574620|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574621|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574622|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574623|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574624|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574625|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574626|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574627|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574628|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574629|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574630|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574631|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574632|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574633|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574634|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574635|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574636|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574637|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574638|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574639|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574640|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574641|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574642|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574643|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574644|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574645|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574646|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574647|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574648|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574649|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574650|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574651|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574652|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574653|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574654|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574655|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574656|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574657|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574658|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574659|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574660|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574661|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574662|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574663|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574664|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574665|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
574666|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
574667|NCT00578968|E3|Reported Event|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
574668|NCT00578968|E2|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
574669|NCT00578968|E1|Reported Event|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
574670|NCT00578942|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
574671|NCT00578942|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
574672|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
574673|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
574674|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
574675|NCT00578942|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
574676|NCT00578929|B5|Baseline|Total|Total of all reporting groups
574677|NCT00578929|B4|Baseline|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
574678|NCT00578929|B3|Baseline|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
574679|NCT00578929|B2|Baseline|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
574680|NCT00578929|B1|Baseline|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
574682|NCT00578929|P3|Participant Flow|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
574683|NCT00578929|P2|Participant Flow|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
574684|NCT00578929|P1|Participant Flow|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
574685|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
574686|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
574687|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
574688|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
574689|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
574690|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
574691|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
574692|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
574693|NCT00578929|E5|Reported Event|Vehicle Run-in Period|Vehicle Run-in Period
574694|NCT00578929|E4|Reported Event|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
574695|NCT00578929|E3|Reported Event|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
574696|NCT00578929|E2|Reported Event|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
574697|NCT00578929|E1|Reported Event|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
574698|NCT00578903|B1|Baseline|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574699|NCT00578903|P1|Participant Flow|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574700|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574701|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574702|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574703|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574704|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574705|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574706|NCT00578903|E1|Reported Event|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
574707|NCT00578877|B3|Baseline|Total|Total of all reporting groups
574708|NCT00578877|B2|Baseline|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574709|NCT00578877|B1|Baseline|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574710|NCT00578877|P2|Participant Flow|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574711|NCT00578877|P1|Participant Flow|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574712|NCT00578877|O2|Outcome|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574713|NCT00578877|O1|Outcome|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574714|NCT00578877|E2|Reported Event|BufferGel With SILCS Diaphragm|Participants used the SILCS diaphragm with BufferGel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574715|NCT00578877|E1|Reported Event|N-9 Gel With SILCS Diaphragm|Participants used the SILCS diaphragm with the N-9 gel as her only method of contraception for at least 190 days and at least 6 menstrual cycles
574716|NCT00578864|B3|Baseline|Total|Total of all reporting groups
574717|NCT00578864|B2|Baseline|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574718|NCT00578864|B1|Baseline|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574719|NCT00578864|P2|Participant Flow|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574720|NCT00578864|P1|Participant Flow|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574721|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574722|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574723|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574724|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574725|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574726|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574727|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574728|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574729|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574730|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574731|NCT00578864|E2|Reported Event|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
574732|NCT00578864|E1|Reported Event|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
574733|NCT00578812|B3|Baseline|Total|Total of all reporting groups
574734|NCT00578812|B2|Baseline|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574735|NCT00578812|B1|Baseline|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574736|NCT00578812|P2|Participant Flow|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574737|NCT00578812|P1|Participant Flow|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574738|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574739|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574740|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574741|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574742|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574743|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574744|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574745|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574746|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574747|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574748|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574749|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574750|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574751|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574752|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574753|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574754|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574755|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574756|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574757|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574758|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
575769|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
574759|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574760|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574761|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574762|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574763|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574764|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574765|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574766|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574767|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574768|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574769|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574770|NCT00578812|E2|Reported Event|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574771|NCT00578812|E1|Reported Event|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
574772|NCT00578786|B4|Baseline|Total|Total of all reporting groups
574773|NCT00578786|B3|Baseline|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
574774|NCT00578786|B2|Baseline|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
574775|NCT00578786|B1|Baseline|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
574776|NCT00578786|P3|Participant Flow|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
574777|NCT00578786|P2|Participant Flow|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
574778|NCT00578786|P1|Participant Flow|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
574779|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574780|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574781|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574782|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
574783|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574784|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574785|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574786|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
574787|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574862|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
574788|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574789|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574790|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
574791|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574792|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574793|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574794|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
574795|NCT00578786|O1|Outcome|Combined Ambrisentan Group|(All Doses)
574796|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
574797|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
574798|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574799|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574800|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574801|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574802|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574803|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574804|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574805|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574806|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
574807|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574808|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574809|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574810|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
574811|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574812|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574813|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574814|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574815|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574816|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574817|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574818|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574819|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574820|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574821|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574822|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574823|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574824|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574863|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
574825|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574826|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574827|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574828|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574829|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574830|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574831|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574832|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574833|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574834|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574835|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574836|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574837|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574838|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
574839|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574840|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574841|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574842|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574843|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574844|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574845|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574846|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574847|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574848|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574849|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
574850|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574851|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574852|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574853|NCT00578786|E3|Reported Event|Ambrisentan 10 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574854|NCT00578786|E2|Reported Event|Ambrisentan 5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574855|NCT00578786|E1|Reported Event|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
574856|NCT00578734|B3|Baseline|Total|Total of all reporting groups
574857|NCT00578734|B2|Baseline|Sham Air|Sham air (placebo) instillation
574858|NCT00578734|B1|Baseline|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
574859|NCT00578734|P2|Participant Flow|Sham Air|Sham air (placebo) instillation
574860|NCT00578734|P1|Participant Flow|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
574861|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
574864|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
574865|NCT00578734|E2|Reported Event|Sham Air|Sham air (placebo) instillation
574866|NCT00578734|E1|Reported Event|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
574867|NCT00578617|B3|Baseline|Total|Total of all reporting groups
574868|NCT00578617|B2|Baseline|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
574869|NCT00578617|B1|Baseline|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
574870|NCT00578617|P2|Participant Flow|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
574871|NCT00578617|P1|Participant Flow|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
574872|NCT00578617|O2|Outcome|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
574873|NCT00578617|O1|Outcome|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
574874|NCT00578617|E2|Reported Event|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
574875|NCT00578617|E1|Reported Event|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
574876|NCT00578565|B1|Baseline|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
574877|NCT00578565|P1|Participant Flow|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
574878|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
574879|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
574880|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
574881|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
574882|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
574883|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
574884|NCT00578565|E1|Reported Event|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
574885|NCT00578552|B4|Baseline|Total|Total of all reporting groups
574886|NCT00578552|B3|Baseline|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574887|NCT00578552|B2|Baseline|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574888|NCT00578552|B1|Baseline|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574889|NCT00578552|P3|Participant Flow|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574890|NCT00578552|P2|Participant Flow|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574931|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574891|NCT00578552|P1|Participant Flow|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574892|NCT00578552|O3|Outcome|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574893|NCT00578552|O2|Outcome|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574894|NCT00578552|O1|Outcome|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574895|NCT00578552|E3|Reported Event|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574896|NCT00578552|E2|Reported Event|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574897|NCT00578552|E1|Reported Event|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
574898|NCT00578539|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
574899|NCT00578539|P1|Participant Flow|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
574900|NCT00578539|O1|Outcome|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
574901|NCT00578539|E1|Reported Event|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
574902|NCT00578461|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
574903|NCT00578461|P1|Participant Flow|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.~Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
574904|NCT00578461|O1|Outcome|Stem Cell Transplant|All patients will be receiving a stem cell transplant on study. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation.
574905|NCT00578461|E1|Reported Event|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
574906|NCT00578448|B1|Baseline|IV Belatacept 10mg/kg With 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial.
574907|NCT00578448|P1|Participant Flow|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial (3 years and then a 1 year extension was available for those who completed the 3rd year).
575386|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
574908|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574909|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574910|NCT00578448|O1|Outcome|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study (3 years planned study; 1 year extension allowed to those who completed 3rd year).
574911|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574912|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574913|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574914|NCT00578448|O1|Outcome|10mg/kg IV Belatacept|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574915|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574916|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574917|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574918|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
574919|NCT00578448|E1|Reported Event|Bela 10-5mg/kg|
574920|NCT00578383|B5|Baseline|Total|Total of all reporting groups
574921|NCT00578383|B4|Baseline|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574922|NCT00578383|B3|Baseline|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574923|NCT00578383|B2|Baseline|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574924|NCT00578383|B1|Baseline|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574925|NCT00578383|P4|Participant Flow|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574926|NCT00578383|P3|Participant Flow|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574927|NCT00578383|P2|Participant Flow|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574928|NCT00578383|P1|Participant Flow|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574929|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
574930|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
575387|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
574932|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574933|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
574934|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574935|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574936|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574937|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
574938|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574939|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574940|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574941|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
574942|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574943|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574944|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574945|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574946|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
574947|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574948|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
574949|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574950|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
574951|NCT00578383|O2|Outcome|Combined Group Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574952|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
574953|NCT00578383|E4|Reported Event|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574954|NCT00578383|E3|Reported Event|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574955|NCT00578383|E2|Reported Event|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
574956|NCT00578383|E1|Reported Event|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
574957|NCT00578331|B3|Baseline|Total|Total of all reporting groups
574958|NCT00578331|B2|Baseline|Olopatadine 0.6% Nasal Spray|
574959|NCT00578331|B1|Baseline|Placebo Nasal Spray|
574960|NCT00578331|P2|Participant Flow|Olopatadine 0.6% Nasal Spray|2 sprays each nostril twice daily
574961|NCT00578331|P1|Participant Flow|Placebo Nasal Spray|2 sprays each nostril twice daily
574962|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
574963|NCT00578331|O1|Outcome|Placebo Nasal Spray|
574964|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
574965|NCT00578331|O1|Outcome|Placebo Nasal Spray|
574966|NCT00578331|E2|Reported Event|Olopatadine 0.6% Nasal Spray|
574967|NCT00578331|E1|Reported Event|Placebo Nasal Spray|
574968|NCT00578318|B3|Baseline|Total|Total of all reporting groups
574969|NCT00578318|B2|Baseline|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
575388|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
574970|NCT00578318|B1|Baseline|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
574971|NCT00578318|P2|Participant Flow|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
574972|NCT00578318|P1|Participant Flow|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
574973|NCT00578318|O2|Outcome|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
574974|NCT00578318|O1|Outcome|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
574975|NCT00578318|E2|Reported Event|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
574976|NCT00578318|E1|Reported Event|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
574977|NCT00578305|B4|Baseline|Total|Total of all reporting groups
574978|NCT00578305|B3|Baseline|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574979|NCT00578305|B2|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574980|NCT00578305|B1|Baseline|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574981|NCT00578305|P3|Participant Flow|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574982|NCT00578305|P2|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574983|NCT00578305|P1|Participant Flow|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574984|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574985|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575067|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575770|NCT00577135|O4|Outcome|High Intensification|
574986|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574987|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574988|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574989|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574990|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574991|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574992|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574993|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574994|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574995|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575068|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575069|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575070|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
574996|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574997|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574998|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
574999|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575000|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575001|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575002|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575003|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575004|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575005|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575071|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575072|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575073|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575006|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575007|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575008|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575009|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575010|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575011|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575012|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575013|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575014|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575015|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575074|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575075|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575076|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575016|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575017|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575018|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575019|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575020|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575021|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575022|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575023|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575024|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575025|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575077|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575078|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575079|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575026|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575027|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575028|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575029|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575030|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575031|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575032|NCT00578305|E9|Reported Event|Placebo - Safety Follow-up Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575033|NCT00578305|E8|Reported Event|Rituximab 1000 mg - Safety Follow-up Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575034|NCT00578305|E7|Reported Event|Rituximab 500 mg - Safety Follow-up Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575035|NCT00578305|E6|Reported Event|Placebo - Extension Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575080|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575081|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575036|NCT00578305|E5|Reported Event|Rituximab 1000 mg - Extension Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575037|NCT00578305|E4|Reported Event|Rituximab 500 mg - Extension Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575038|NCT00578305|E3|Reported Event|Placebo - Double-blind Treatment Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575039|NCT00578305|E2|Reported Event|Rituximab 1000 mg - Double-blind Treatment Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575040|NCT00578305|E1|Reported Event|Rituximab 500 mg - Double-blind Treatment Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
575041|NCT00578279|B3|Baseline|Total|Total of all reporting groups
575042|NCT00578279|B2|Baseline|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
575043|NCT00578279|B1|Baseline|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
575044|NCT00578279|P2|Participant Flow|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
575045|NCT00578279|P1|Participant Flow|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
575046|NCT00578279|O2|Outcome|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
575047|NCT00578279|O1|Outcome|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
575048|NCT00578279|E2|Reported Event|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
575049|NCT00578279|E1|Reported Event|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
575050|NCT00578227|B4|Baseline|Total|Total of all reporting groups
575051|NCT00578227|B3|Baseline|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575052|NCT00578227|B2|Baseline|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575053|NCT00578227|B1|Baseline|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575054|NCT00578227|P3|Participant Flow|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575055|NCT00578227|P2|Participant Flow|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575056|NCT00578227|P1|Participant Flow|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575057|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575058|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575059|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575060|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575061|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575062|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575063|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575064|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575065|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575066|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575389|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575082|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575083|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575084|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575085|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575086|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575087|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575088|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575089|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575090|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575091|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575092|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575093|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
575094|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575095|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575096|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575097|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
575098|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575099|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575100|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575101|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575102|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575103|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575104|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575105|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575106|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575107|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575108|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575109|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575110|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575111|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575112|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575113|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575114|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575115|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575116|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575117|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575118|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575119|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575120|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575121|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575122|NCT00578227|E3|Reported Event|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
575123|NCT00578227|E2|Reported Event|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
575124|NCT00578227|E1|Reported Event|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
575125|NCT00578214|B4|Baseline|Total|Total of all reporting groups
575126|NCT00578214|B3|Baseline|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575127|NCT00578214|B2|Baseline|Placebo|Randomized patients receiving placebo syrup
575128|NCT00578214|B1|Baseline|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575129|NCT00578214|P3|Participant Flow|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575130|NCT00578214|P2|Participant Flow|Placebo|Randomized patients receiving placebo syrup
575131|NCT00578214|P1|Participant Flow|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575132|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575133|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575134|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575135|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575136|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575137|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575138|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575139|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575140|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575141|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575142|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575143|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575144|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575145|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575146|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575147|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575148|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575149|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575150|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575151|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575152|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575153|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575154|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575155|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575156|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575157|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575158|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575159|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575160|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575161|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575162|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575163|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575164|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575165|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575166|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575167|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575168|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575169|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575170|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575171|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575172|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
575173|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575174|NCT00578214|E3|Reported Event|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
575175|NCT00578214|E2|Reported Event|Placebo|Randomized patients receiving placebo syrup
575176|NCT00578214|E1|Reported Event|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
575177|NCT00578175|B4|Baseline|Total|Total of all reporting groups
575178|NCT00578175|B3|Baseline|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575179|NCT00578175|B2|Baseline|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575390|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575180|NCT00578175|B1|Baseline|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575181|NCT00578175|P3|Participant Flow|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575182|NCT00578175|P2|Participant Flow|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575183|NCT00578175|P1|Participant Flow|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575184|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575185|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575186|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575187|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575188|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575189|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575190|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575191|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575192|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575193|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575194|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575195|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575196|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575197|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575198|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575199|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575391|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575200|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575201|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575202|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575203|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575204|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575205|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575206|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575207|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575208|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575209|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575210|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575211|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575212|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575213|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575214|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575215|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575216|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575217|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575218|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575219|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575220|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575221|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575222|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575223|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575224|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575225|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575226|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575227|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575228|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575229|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575230|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575231|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575232|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575233|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575234|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575235|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575236|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575237|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575238|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575239|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575392|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575240|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575241|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575242|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575243|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575244|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575245|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575246|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575247|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575248|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575249|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575250|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575251|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575252|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575253|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575254|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575255|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575256|NCT00578175|E3|Reported Event|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
575257|NCT00578175|E2|Reported Event|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575258|NCT00578175|E1|Reported Event|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
575259|NCT00578136|B3|Baseline|Total|Total of all reporting groups
575260|NCT00578136|B2|Baseline|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
575261|NCT00578136|B1|Baseline|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
575262|NCT00578136|P2|Participant Flow|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
575263|NCT00578136|P1|Participant Flow|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
575264|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
575265|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
575266|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
575267|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
575268|NCT00578136|E2|Reported Event|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
575269|NCT00578136|E1|Reported Event|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
575270|NCT00578071|B1|Baseline|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
575271|NCT00578071|P1|Participant Flow|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
575272|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
575273|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
575274|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
575275|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
575276|NCT00578071|E1|Reported Event|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
575277|NCT00577889|B4|Baseline|Total|Total of all reporting groups
575278|NCT00577889|B3|Baseline|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575279|NCT00577889|B2|Baseline|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575280|NCT00577889|B1|Baseline|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575281|NCT00577889|P3|Participant Flow|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575282|NCT00577889|P2|Participant Flow|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575283|NCT00577889|P1|Participant Flow|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575284|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575285|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575286|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575287|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575288|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575289|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575316|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575290|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575291|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575292|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575293|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575294|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575295|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575296|NCT00577889|E3|Reported Event|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575297|NCT00577889|E2|Reported Event|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575298|NCT00577889|E1|Reported Event|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
575299|NCT00577863|B3|Baseline|Total|Total of all reporting groups
575300|NCT00577863|B2|Baseline|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
575301|NCT00577863|B1|Baseline|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
575302|NCT00577863|P2|Participant Flow|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
575303|NCT00577863|P1|Participant Flow|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
575304|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
575305|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
575306|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575307|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575308|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575309|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575310|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575311|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575312|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575313|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575314|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575315|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575385|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575317|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575318|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575319|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575320|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575321|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575322|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575323|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575324|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575325|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575326|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575327|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575328|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575329|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575330|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575331|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575332|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575333|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575334|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575335|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575336|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
575337|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575338|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
575339|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
575340|NCT00577863|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms per day
575341|NCT00577824|B4|Baseline|Total|Total of all reporting groups
575342|NCT00577824|B3|Baseline|Placebo BID|placebo SC, twice daily
575343|NCT00577824|B2|Baseline|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575344|NCT00577824|B1|Baseline|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575345|NCT00577824|P3|Participant Flow|Placebo BID|placebo SC, twice daily
575346|NCT00577824|P2|Participant Flow|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575347|NCT00577824|P1|Participant Flow|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575348|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575349|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575350|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575351|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575352|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575353|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575354|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575355|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575356|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575357|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575358|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575359|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575360|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575361|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575362|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575363|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575364|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575365|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575366|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575367|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575368|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575369|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575370|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575371|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575372|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575373|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575374|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575375|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575376|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575377|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575378|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575379|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575380|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575381|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575382|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575383|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575384|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575394|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575395|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575396|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
575397|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575398|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575399|NCT00577824|E3|Reported Event|Placebo BID|placebo SC, twice daily
575400|NCT00577824|E2|Reported Event|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
575401|NCT00577824|E1|Reported Event|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
575402|NCT00577772|B3|Baseline|Total|Total of all reporting groups
575403|NCT00577772|B2|Baseline|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
575404|NCT00577772|B1|Baseline|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
575405|NCT00577772|P2|Participant Flow|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
575406|NCT00577772|P1|Participant Flow|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
575407|NCT00577772|O2|Outcome|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
575408|NCT00577772|O1|Outcome|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
575409|NCT00577772|E2|Reported Event|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
575410|NCT00577772|E1|Reported Event|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
575411|NCT00577720|B5|Baseline|Total|Total of all reporting groups
575412|NCT00577720|B4|Baseline|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575413|NCT00577720|B3|Baseline|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575414|NCT00577720|B2|Baseline|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575415|NCT00577720|B1|Baseline|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575416|NCT00577720|P4|Participant Flow|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575417|NCT00577720|P3|Participant Flow|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575418|NCT00577720|P2|Participant Flow|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575419|NCT00577720|P1|Participant Flow|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575420|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575421|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575422|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575423|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575424|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575425|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575426|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575427|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575428|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575429|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575430|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575431|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575432|NCT00577720|E4|Reported Event|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575433|NCT00577720|E3|Reported Event|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575434|NCT00577720|E2|Reported Event|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
575435|NCT00577720|E1|Reported Event|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
575436|NCT00577707|B1|Baseline|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
575437|NCT00577707|P1|Participant Flow|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
575438|NCT00577707|O1|Outcome|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
575439|NCT00577707|O1|Outcome|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
575440|NCT00577707|O1|Outcome|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
575441|NCT00577707|E1|Reported Event|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
575442|NCT00577655|B3|Baseline|Total|Total of all reporting groups
575443|NCT00577655|B2|Baseline|Placebo|Placebo HFA-MDI four times a day for 21 days.
575444|NCT00577655|B1|Baseline|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575445|NCT00577655|P2|Participant Flow|Placebo|Placebo HFA-MDI four times a day for 21 days.
575446|NCT00577655|P1|Participant Flow|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575447|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575448|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575449|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575450|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575451|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575452|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575453|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575454|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575455|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575456|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575457|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575458|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575459|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575460|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575461|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575462|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575463|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575464|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575465|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575466|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575467|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
575771|NCT00577135|O3|Outcome|Low Intensification|
575468|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575469|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575470|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575471|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
575472|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575473|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
575474|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575475|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
575476|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575477|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
575478|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575479|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
575480|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
575481|NCT00577655|E2|Reported Event|Placebo|Placebo HFA-MDI four times a day for 21 days.
575482|NCT00577655|E1|Reported Event|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day
575483|NCT00577642|B1|Baseline|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period
575484|NCT00577642|P1|Participant Flow|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.
575485|NCT00577642|O1|Outcome|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) treatment cessation during study period.
575486|NCT00577642|E1|Reported Event|Single Arm Study|This was a nonintervention biomarker study after a single dose of Zoledronic acid.
575487|NCT00577629|B1|Baseline|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
575488|NCT00577629|P1|Participant Flow|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
575489|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
575490|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar)
575491|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
575492|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
575493|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
575494|NCT00577629|E1|Reported Event|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
575495|NCT00577512|B1|Baseline|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
575496|NCT00577512|P1|Participant Flow|HD DTPACE|"High dose DTPACE (dexamethasone 200 mg days 1-7; thalidomide 200 mg days 1-4; cisplatin 15 mg/m2 days 1-4; adriamycin 15 mg/m2 days 1-4; cyclophosphamide 600 mg/m2 days 1-4; etoposide 60 mg/m2 days 1-4) and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion repeated every 18-21 days for 4 cycles~Bortezomib (1.0 mg/m2 Day 1, 4, 8, 11), thalidomide (100 mg/m2 days 1-21), and dexamethasone (20 mg days 1-4 and 9-12) (VTD) Maintenance therapy"
575497|NCT00577512|O1|Outcome|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
575498|NCT00577512|E1|Reported Event|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
575499|NCT00577473|B3|Baseline|Total|Total of all reporting groups
575500|NCT00577473|B2|Baseline|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575501|NCT00577473|B1|Baseline|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575502|NCT00577473|P2|Participant Flow|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575503|NCT00577473|P1|Participant Flow|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575504|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575505|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575506|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575507|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575508|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575772|NCT00577135|O2|Outcome|Continuous Infusion|
575509|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575510|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575511|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575512|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575513|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575514|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575515|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575516|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575517|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575518|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575519|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575520|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575521|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575522|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575523|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575524|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575525|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575526|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575527|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575528|NCT00577473|E2|Reported Event|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
575529|NCT00577473|E1|Reported Event|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
575530|NCT00577460|B4|Baseline|Total|Total of all reporting groups
575531|NCT00577460|B3|Baseline|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575532|NCT00577460|B2|Baseline|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575533|NCT00577460|B1|Baseline|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575534|NCT00577460|P3|Participant Flow|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial
575535|NCT00577460|P2|Participant Flow|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575536|NCT00577460|P1|Participant Flow|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575537|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575538|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575539|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575540|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575541|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575542|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575543|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575544|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575545|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575546|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575547|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575548|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575549|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575550|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575551|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575552|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575553|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575554|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575555|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575556|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575557|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575558|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575559|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575773|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575560|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575561|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575562|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575563|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575564|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575565|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575566|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575567|NCT00577460|O3|Outcome|PPX IR|Treatment with Pramipexole IR in previous trial
575568|NCT00577460|O2|Outcome|PPX ER|Treatment with Pramipexole ER in previous trial
575569|NCT00577460|O1|Outcome|Placebo|Treatment with matching placebo in previous trial (NCT00466167)
575570|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
575571|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575572|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575573|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575574|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
575575|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575576|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575577|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575578|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
575579|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575580|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575581|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575582|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575583|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575584|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575585|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575586|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575587|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575588|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575589|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575590|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575591|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575592|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575593|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575594|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575595|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575596|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575597|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
575598|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575599|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575600|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575601|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
575602|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575603|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575604|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575605|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
575606|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575607|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575608|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575609|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575610|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575611|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575612|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575613|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575614|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575615|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575616|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575617|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575618|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575619|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575620|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575621|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
575622|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575623|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575624|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575625|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575626|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575627|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575628|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575629|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575630|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575631|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575632|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575633|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575634|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575635|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575636|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575637|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575638|NCT00577460|E4|Reported Event|Total PPX ER|Pramipexole ER, all patients
575639|NCT00577460|E3|Reported Event|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
575640|NCT00577460|E2|Reported Event|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
575641|NCT00577460|E1|Reported Event|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
575642|NCT00577408|B3|Baseline|Total|Total of all reporting groups
575643|NCT00577408|B2|Baseline|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
575644|NCT00577408|B1|Baseline|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
575645|NCT00577408|P2|Participant Flow|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
575646|NCT00577408|P1|Participant Flow|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
575647|NCT00577408|O2|Outcome|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
575648|NCT00577408|O1|Outcome|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
575649|NCT00577408|E2|Reported Event|Oral Naltrexone|"Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).~Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor."
575650|NCT00577408|E1|Reported Event|Depot Naltrexone|Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
575651|NCT00577395|B3|Baseline|Total|Total of all reporting groups
575652|NCT00577395|B2|Baseline|Placebo Tablet Once a Month|Placebo tablet once a month, orally
575653|NCT00577395|B1|Baseline|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
575654|NCT00577395|P2|Participant Flow|Placebo Tablet Once a Month|Placebo tablet once a month, orally
575655|NCT00577395|P1|Participant Flow|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
575656|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
575657|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
575658|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
575659|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
575660|NCT00577395|E2|Reported Event|Placebo Tablet Once a Month|Placebo tablet once a month, orally
575661|NCT00577395|E1|Reported Event|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
575662|NCT00577382|B3|Baseline|Total|Total of all reporting groups
575663|NCT00577382|B2|Baseline|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
575664|NCT00577382|B1|Baseline|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
575665|NCT00577382|P2|Participant Flow|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
575666|NCT00577382|P1|Participant Flow|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
575667|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
575668|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
575669|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
575670|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
575671|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
575672|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
575673|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
575674|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
575675|NCT00577382|E2|Reported Event|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
575676|NCT00577382|E1|Reported Event|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
575677|NCT00577356|B1|Baseline|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
575774|NCT00577135|O4|Outcome|High Intensification|
575775|NCT00577135|O3|Outcome|Low Intensification|
575776|NCT00577135|O2|Outcome|Continuous Infusion|
575777|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575678|NCT00577356|P1|Participant Flow|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
575679|NCT00577356|O1|Outcome|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
575680|NCT00577356|E1|Reported Event|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
575681|NCT00577135|B5|Baseline|Total|Total of all reporting groups
575682|NCT00577135|B4|Baseline|Continuous Infusion & High Intensification|
575683|NCT00577135|B3|Baseline|Continuous Infusion & Low Intensification|
575684|NCT00577135|B2|Baseline|Q12 Hours Bolus & High Intensification|
575685|NCT00577135|B1|Baseline|Q12 Hours Bolus & Low Intensification|
575686|NCT00577135|P4|Participant Flow|Continuous Infusion & High Intensification|High intensification (2.5 x oral dose) IV furosemide by continuous infusion
575687|NCT00577135|P3|Participant Flow|Continuous Infusion & Low Intensification|Low intensification (1 x oral dose) IV furosemide by continuous infusion
575688|NCT00577135|P2|Participant Flow|Q12 Hours Bolus & High Intensification|High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus
575689|NCT00577135|P1|Participant Flow|Q12 Hours Bolus & Low Intensification|Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
575690|NCT00577135|O4|Outcome|High Intensification|
575691|NCT00577135|O3|Outcome|Low Intensification|
575692|NCT00577135|O2|Outcome|Continuous Infusion|
575693|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575694|NCT00577135|O4|Outcome|High Intensification|
575695|NCT00577135|O3|Outcome|Low Intensification|
575696|NCT00577135|O2|Outcome|Continuous Infusion|
575697|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575698|NCT00577135|O4|Outcome|High Intensification|
575699|NCT00577135|O3|Outcome|Low Intensification|
575700|NCT00577135|O2|Outcome|Continuous Infusion|
575701|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575702|NCT00577135|O4|Outcome|High Intensification|
575703|NCT00577135|O3|Outcome|Low Intensification|
575704|NCT00577135|O2|Outcome|Continuous Infusion|
575705|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575706|NCT00577135|O4|Outcome|High Intensification|
575707|NCT00577135|O3|Outcome|Low Intensification|
575708|NCT00577135|O2|Outcome|Continuous Infusion|
575709|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575710|NCT00577135|O4|Outcome|High Intensification|
575711|NCT00577135|O3|Outcome|Low Intensification|
575712|NCT00577135|O2|Outcome|Continuous Infusion|
575713|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575714|NCT00577135|O4|Outcome|High Intensification|
575715|NCT00577135|O3|Outcome|Low Intensification|
575716|NCT00577135|O2|Outcome|Continuous Infusion|
575717|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575718|NCT00577135|O4|Outcome|High Intensification|
575719|NCT00577135|O3|Outcome|Low Intensification|
575720|NCT00577135|O2|Outcome|Continuous Infusion|
575721|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575722|NCT00577135|O4|Outcome|High Intensification|
575723|NCT00577135|O3|Outcome|Low Intensification|
575724|NCT00577135|O2|Outcome|Continuous Infusion|
575725|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575726|NCT00577135|O4|Outcome|High Intensification|
575727|NCT00577135|O3|Outcome|Low Intensification|
575728|NCT00577135|O2|Outcome|Continuous Infusion|
575729|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575730|NCT00577135|O4|Outcome|High Intensification|
575731|NCT00577135|O3|Outcome|Low Intensification|
575732|NCT00577135|O2|Outcome|Continuous Infusion|
575733|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575734|NCT00577135|O4|Outcome|High Intensification|
575735|NCT00577135|O3|Outcome|Low Intensification|
575736|NCT00577135|O2|Outcome|Continuous Infusion|
575737|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575738|NCT00577135|O4|Outcome|High Intensification|
575739|NCT00577135|O3|Outcome|Low Intensification|
575740|NCT00577135|O2|Outcome|Continuous Infusion|
575741|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575742|NCT00577135|O4|Outcome|High Intensification|
575743|NCT00577135|O3|Outcome|Low Intensification|
575744|NCT00577135|O2|Outcome|Continuous Infusion|
575745|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575778|NCT00577135|O4|Outcome|High Intensification|
575779|NCT00577135|O3|Outcome|Low Intensification|
575780|NCT00577135|O2|Outcome|Continuous Infusion|
575781|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575782|NCT00577135|O4|Outcome|High Intensification|
575783|NCT00577135|O3|Outcome|Low Intensification|
575784|NCT00577135|O2|Outcome|Continuous Infusion|
575785|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575786|NCT00577135|O4|Outcome|High Intensification|
575787|NCT00577135|O3|Outcome|Low Intensification|
575788|NCT00577135|O2|Outcome|Continuous Infusion|
575789|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575790|NCT00577135|O4|Outcome|High Intensification|
575791|NCT00577135|O3|Outcome|Low Intensification|
575792|NCT00577135|O2|Outcome|Continuous Infusion|
575793|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575794|NCT00577135|O4|Outcome|High Intensification|
575795|NCT00577135|O3|Outcome|Low Intensification|
575796|NCT00577135|O2|Outcome|Continuous Infusion|
575797|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575798|NCT00577135|O4|Outcome|High Intensification|
575799|NCT00577135|O3|Outcome|Low Intensification|
575800|NCT00577135|O2|Outcome|Continuous Infusion|
575801|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
575802|NCT00577135|E4|Reported Event|High Intensification|
575803|NCT00577135|E3|Reported Event|Low Intensification|
575804|NCT00577135|E2|Reported Event|Continuous Infusion|
575805|NCT00577135|E1|Reported Event|Q 12 Hour Bolus|
575806|NCT00577122|B3|Baseline|Total|Total of all reporting groups
575807|NCT00577122|B2|Baseline|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
575808|NCT00577122|B1|Baseline|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
575809|NCT00577122|P2|Participant Flow|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
575810|NCT00577122|P1|Participant Flow|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
575811|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
575812|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
575813|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
575814|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
575815|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
575816|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
575817|NCT00577122|O2|Outcome|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
575818|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
575819|NCT00577122|E2|Reported Event|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
575820|NCT00577122|E1|Reported Event|Cohort 1: MPA Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
575821|NCT00577096|B3|Baseline|Total|Total of all reporting groups
575822|NCT00577096|B2|Baseline|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575823|NCT00577096|B1|Baseline|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575824|NCT00577096|P2|Participant Flow|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575825|NCT00577096|P1|Participant Flow|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575826|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575827|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575828|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575829|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575830|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575860|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575831|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575832|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575833|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575834|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575835|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575836|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575837|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575858|NCT00577031|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575838|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575839|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575840|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575841|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575842|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575843|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575844|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575859|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575845|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575846|NCT00577096|E2|Reported Event|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
575847|NCT00577096|E1|Reported Event|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
575848|NCT00577083|B3|Baseline|Total|Total of all reporting groups
575849|NCT00577083|B2|Baseline|Initial Cap-fitted First Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575850|NCT00577083|B1|Baseline|No Cap First, Then Cap Fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575851|NCT00577083|P2|Participant Flow|Initial Cap-fitted First, Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575852|NCT00577083|P1|Participant Flow|No Cap First, Then Cap-fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575853|NCT00577083|O2|Outcome|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575854|NCT00577083|O1|Outcome|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575855|NCT00577083|E2|Reported Event|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575856|NCT00577083|E1|Reported Event|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
575857|NCT00577031|B1|Baseline|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
576389|NCT00576147|B1|Baseline|CT Scan|The standard head CT done to head trauma patients
575861|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575862|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575863|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575864|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575865|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575866|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575867|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575868|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575869|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575870|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575871|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles):~Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day~1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):~If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575872|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575873|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575874|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575875|NCT00577031|E1|Reported Event|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
575876|NCT00577005|B3|Baseline|Total|Total of all reporting groups
575877|NCT00577005|B2|Baseline|Placebo|"matching placebo~Placebo"
575878|NCT00577005|B1|Baseline|Levetiracetam|"Levetiracetam tablets~levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
575879|NCT00577005|P2|Participant Flow|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
575880|NCT00577005|P1|Participant Flow|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
575881|NCT00577005|O2|Outcome|Placebo|"matching placebo~Placebo"
575882|NCT00577005|O1|Outcome|Levetiracetam|"Levetiracetam tablets~levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
575883|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
575884|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
575885|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
575886|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
575887|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
575888|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
575889|NCT00577005|E2|Reported Event|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
575890|NCT00577005|E1|Reported Event|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
575891|NCT00576927|B3|Baseline|Total|Total of all reporting groups
575892|NCT00576927|B2|Baseline|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
575893|NCT00576927|B1|Baseline|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
575894|NCT00576927|P1|Participant Flow|All Subjects|
575895|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
575896|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
576390|NCT00576147|P1|Participant Flow|CT Scan|The standard head CT done to head trauma patients
575897|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
575898|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
575899|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
575900|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
575901|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
575902|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
575903|NCT00576927|E2|Reported Event|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
575904|NCT00576927|E1|Reported Event|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
575905|NCT00576901|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575906|NCT00576901|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m^2), IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575907|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575908|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575909|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575910|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575911|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575912|NCT00576901|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
575913|NCT00576823|B4|Baseline|Total|Total of all reporting groups
575914|NCT00576823|B3|Baseline|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
575915|NCT00576823|B2|Baseline|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
575916|NCT00576823|B1|Baseline|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
575917|NCT00576823|P3|Participant Flow|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
575918|NCT00576823|P2|Participant Flow|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
575919|NCT00576823|P1|Participant Flow|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
575920|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
575921|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
575922|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
575923|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
575924|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
575925|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
575926|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
575994|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
575927|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
575928|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
575929|NCT00576823|E3|Reported Event|Afluzosin Tablets - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
575930|NCT00576823|E2|Reported Event|Afluzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
575931|NCT00576823|E1|Reported Event|Afluzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
575932|NCT00576758|B3|Baseline|Total|Total of all reporting groups
575933|NCT00576758|B2|Baseline|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575934|NCT00576758|B1|Baseline|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575935|NCT00576758|P2|Participant Flow|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575936|NCT00576758|P1|Participant Flow|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575937|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575938|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575939|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575940|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575941|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575942|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575943|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575944|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575945|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575946|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575947|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575948|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575949|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575950|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575951|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575952|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575953|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575954|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575955|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575956|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575957|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575958|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575995|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
575996|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
576078|NCT00576472|B2|Baseline|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
575959|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575960|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575961|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575962|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575963|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575964|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575965|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575966|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575967|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575968|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575969|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575970|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575971|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575972|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575997|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
575998|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
575973|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575974|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575975|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575976|NCT00576758|E2|Reported Event|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575977|NCT00576758|E1|Reported Event|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
575978|NCT00576732|B4|Baseline|Total|Total of all reporting groups
575979|NCT00576732|B3|Baseline|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
575980|NCT00576732|B2|Baseline|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
575981|NCT00576732|B1|Baseline|Placebo|Double-blind Period. Oral solution for 6 weeks.
575982|NCT00576732|P6|Participant Flow|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575983|NCT00576732|P5|Participant Flow|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575984|NCT00576732|P4|Participant Flow|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575985|NCT00576732|P3|Participant Flow|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
575986|NCT00576732|P2|Participant Flow|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
575987|NCT00576732|P1|Participant Flow|Placebo|Double-blind Period. Oral solution for 6 weeks.
575988|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575989|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575990|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575991|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575992|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575993|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
575999|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
576000|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
576001|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
576002|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
576003|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
576004|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
576005|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
576006|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
576007|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
576008|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
576009|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
576010|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
576011|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
576012|NCT00576732|E4|Reported Event|Open-label Risperidone|Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
576013|NCT00576732|E3|Reported Event|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
576014|NCT00576732|E2|Reported Event|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
576015|NCT00576732|E1|Reported Event|Placebo|Double-blind Period. Oral solution for 6 weeks.
576016|NCT00576693|B3|Baseline|Total|Total of all reporting groups
576017|NCT00576693|B2|Baseline|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
576018|NCT00576693|B1|Baseline|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
576019|NCT00576693|P2|Participant Flow|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
576020|NCT00576693|P1|Participant Flow|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
576021|NCT00576693|O2|Outcome|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
576038|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576079|NCT00576472|B1|Baseline|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
576022|NCT00576693|O1|Outcome|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
576023|NCT00576693|E2|Reported Event|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
576024|NCT00576693|E1|Reported Event|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
576025|NCT00576628|B1|Baseline|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576026|NCT00576628|P1|Participant Flow|C.E.R.A|Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
576027|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576028|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576029|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576030|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576031|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576032|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576033|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576034|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576035|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576036|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576037|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576077|NCT00576472|B3|Baseline|High|Intensity of prior Central Nervous System radiation therapy was considered high.
576039|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range..
576040|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576041|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576042|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576043|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576044|NCT00576628|E1|Reported Event|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
576045|NCT00576576|B1|Baseline|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
576046|NCT00576576|P1|Participant Flow|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
576047|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
576048|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
576049|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
576050|NCT00576576|E1|Reported Event|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
576051|NCT00576524|B3|Baseline|Total|Total of all reporting groups
576052|NCT00576524|B2|Baseline|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
576053|NCT00576524|B1|Baseline|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
576054|NCT00576524|P2|Participant Flow|Sham Device First, ITD Next|A group of subjects will be randomized to receive sham first, followed by ITD 7 days later.
576055|NCT00576524|P1|Participant Flow|ITD First, Sham Device Next|A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later.
576056|NCT00576524|O2|Outcome|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
576057|NCT00576524|O1|Outcome|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
576058|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device 7 days later.
576059|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, follwed by ITD 7 days later.
576060|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device after 7 days.
576061|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, followed by ITD next after 7 days.
576062|NCT00576524|E2|Reported Event|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
576063|NCT00576524|E1|Reported Event|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
576064|NCT00576472|B16|Baseline|Total|Total of all reporting groups
576065|NCT00576472|B15|Baseline|Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the duration of the Home Maintenance Phase.
576066|NCT00576472|B14|Baseline|Declined Home Maintenance Phase|Patients who completed the MPH Cross Over Phase but chose to decline participation in the Home Maintenance Phase.
576067|NCT00576472|B13|Baseline|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
576068|NCT00576472|B12|Baseline|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
576069|NCT00576472|B11|Baseline|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
576070|NCT00576472|B10|Baseline|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
576071|NCT00576472|B9|Baseline|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a lose dose of Methylphenidate (MPH) on week three.
576072|NCT00576472|B8|Baseline|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
576073|NCT00576472|B7|Baseline|Not Randomized-Cross Over|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross Over Phase
576074|NCT00576472|B6|Baseline|Group P/M|Group P/M (patients receive oral placebo and ten Methylphenidate (MPH))
576075|NCT00576472|B5|Baseline|Group M/P|Group M/P (patients receive oral Methylphenidate (MPH) and then an oral placebo)
576076|NCT00576472|B4|Baseline|Not Randomized-In Lab Phase|Patients not randomized for the MPH in Lab Phase
576080|NCT00576472|P15|Participant Flow|Methylphenidate (MPH) Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the Methylphenidate (MPH) Home Maintenance Phase.
576081|NCT00576472|P14|Participant Flow|Declined Methylphenidate (MPH) Home Maintenance Phase|Patients who completed the Methylphenidate (MPH) Cross Over Phase but chose to decline participation in the Methylphenidate (MPH) Home Maintenance Phase.
576082|NCT00576472|P13|Participant Flow|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
576083|NCT00576472|P12|Participant Flow|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
576084|NCT00576472|P11|Participant Flow|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
576085|NCT00576472|P10|Participant Flow|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
576086|NCT00576472|P9|Participant Flow|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a low dose of Methylphenidate (MPH) on week three.
576087|NCT00576472|P8|Participant Flow|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
576088|NCT00576472|P7|Participant Flow|Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross-Over Phase
576089|NCT00576472|P6|Participant Flow|Group P/M|Group P/M (patients received oral placebo and then Methylphenidate (MPH))
576090|NCT00576472|P5|Participant Flow|Group M/P|Group M/P (patients received oral Methylphenidate (MPH) and then an oral placebo)
576091|NCT00576472|P4|Participant Flow|Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase.
576092|NCT00576472|P3|Participant Flow|High Intensity|Intensity of prior CNS Therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy) classified as high.
576093|NCT00576472|P2|Participant Flow|Moderate Intensity|Intensity of prior CNS Therapy (< 24 Gy CRT with or without systemic and/or intrathecal chemotherapy)classified as moderate.
576094|NCT00576472|P1|Participant Flow|Mild Intensity|Intensity of prior CNS Therapy (systemic and/or intrathecal chemotherapy only)classified as mild.
576095|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576096|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576097|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576098|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576099|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576100|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576189|NCT00576420|P1|Participant Flow|FS VH S/D 500 S-apr - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time
576190|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576191|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576434|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576101|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576102|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576103|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576104|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576105|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576106|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576107|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576108|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576109|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576110|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576111|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576112|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576192|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576193|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576113|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576114|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576115|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576116|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576117|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576118|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576119|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576120|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576121|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576122|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576123|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576124|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576201|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576391|NCT00576147|O1|Outcome|CT Scan|The standard head CT done to head trauma patients
576125|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576126|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576127|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576128|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576129|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576130|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
576131|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576132|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576133|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576134|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576135|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576136|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576319|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576137|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576138|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576139|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576140|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576141|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576142|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576143|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576144|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576145|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576146|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576147|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576194|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576195|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576196|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576148|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576149|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576150|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576151|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576152|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576153|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576154|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576155|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576156|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576157|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576158|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576197|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576198|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576199|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576159|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576160|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
576161|NCT00576472|O3|Outcome|Moderate Dose|Patients assigned to the Moderate Dose group were randomly assigned to receive one of two arms: Group MLP received moderate dose during week one, low dose during week 2, and placebo during week 3; Group MPL received moderate dose during week one, placebo during week 2, and low dose during week 3.
576162|NCT00576472|O2|Outcome|Low Dose|Patients assigned to the Low Dose group were randomly assigned to receive one of two arms: Group LMP received low dose during week one, moderate dose during week 2, and placebo during week 3; Group LPM received low dose during week one, placebo during week 2, and moderate dose during week 3.
576163|NCT00576472|O1|Outcome|Placebo|Patients assigned to the placebo group were randomly assigned to receive one of two arms: Group PLM received placebo during week one, low dose during week 2, and moderate dose during week 3; Group PML received placebo during week one, moderate dose during week 2, and low dose during week 3.
576164|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Math: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
576165|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Spelling: Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
576166|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Reading: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
576167|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
576168|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
576169|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
576170|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: Cognitive Problem T Score Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
576171|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
576172|NCT00576472|O4|Outcome|High Treatment Intensity|High intensity central nervous system therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy.
576173|NCT00576472|O3|Outcome|Moderate Treatment Intensity|Moderately intense central nervous system therapy (<= 24 Gy CRT with or without systemic and/or intrathecal chemotherapy).
576174|NCT00576472|O2|Outcome|Mild Treatment Intensity|Mildly intense central nervous system therapy (systemic and/or intrathecal chemotherapy only)
576175|NCT00576472|O1|Outcome|Siblings|The sibling control group received no radiation therapy.
576176|NCT00576472|O2|Outcome|Patients With Brain Tumors|Patients with brain tumors who had evaluable MRIs.
576177|NCT00576472|O1|Outcome|Patients With ALL|Patients with Acute Lymphoblastic Leukemia (ALL) who had evaluable MRIs.
576178|NCT00576472|O2|Outcome|Siblings|Sibling controls with evaluable MRIs.
576179|NCT00576472|O1|Outcome|Patients|Patients with evaluable MRIs.
576180|NCT00576472|E3|Reported Event|High|Intensity of prior Central Nervous System radiation therapy was considered high.
576181|NCT00576472|E2|Reported Event|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
576182|NCT00576472|E1|Reported Event|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
576183|NCT00576420|B4|Baseline|Total|Total of all reporting groups
576184|NCT00576420|B3|Baseline|Control Group|Manual compression with surgical gauze pads.
576185|NCT00576420|B2|Baseline|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
576186|NCT00576420|B1|Baseline|FS VH S/D 500 S-apr - 60 Seconds|FS VH S/D 500 s-apr, 60 - seconds polymerization time
576187|NCT00576420|P3|Participant Flow|Control Group|Manual compression with surgical gauze pads.
576188|NCT00576420|P2|Participant Flow|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
576200|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576202|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576203|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576204|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576205|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576206|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576207|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576208|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576209|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576210|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576211|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576212|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576213|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576214|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576215|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576216|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576217|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576218|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576219|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576220|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576221|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576222|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576223|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576224|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576225|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576226|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576227|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576228|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576229|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576230|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576231|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576232|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576233|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576234|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576235|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576236|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576237|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576238|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576239|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576240|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576241|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576320|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576321|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
576242|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576243|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576244|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576245|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576246|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576247|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576248|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576249|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576250|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576251|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576252|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576253|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576254|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576255|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576256|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576257|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576258|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576259|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576260|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576261|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576262|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576263|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576264|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576265|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
576266|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576267|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576268|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576269|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576270|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576271|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576272|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576273|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
576274|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576275|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576276|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576277|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
576278|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576279|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
576280|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
576281|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576392|NCT00576147|E1|Reported Event|CT Scan|The standard head CT done to head trauma patients
576282|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576283|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576284|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576285|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
576286|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576287|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576288|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576289|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
576290|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576291|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
576292|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
576293|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
576294|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576295|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
576296|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 60-seconds polymerization
576297|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576298|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576299|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
576300|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
576301|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
576302|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576303|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
576304|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
576305|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
576306|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576307|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
576308|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
576309|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
576310|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576311|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
576312|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr (FS), 60-seconds polymerization
576313|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
576314|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time) (FS All):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576315|NCT00576420|O2|Outcome|FS VH S/D 500 S -Apr - 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization (FS 120)
576316|NCT00576420|O1|Outcome|FS VH S/D 500 S -Apr - 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization (FS 60)
576317|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
576318|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576322|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
576323|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576324|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-Seconds polymerization time
576325|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576326|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576327|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576328|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576329|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization.
576330|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
576331|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576332|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576333|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576334|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576335|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576336|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576337|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576338|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576339|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576340|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576341|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576342|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576343|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576344|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576345|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
576346|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
576347|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
576348|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr- 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
576349|NCT00576420|E4|Reported Event|Control Group|Treatment of the study-suture line will be manual compression with surgical gauze pads.
576350|NCT00576420|E3|Reported Event|Fibrin Sealant All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time~FS VH S/D 500 s-apr, 120 seconds polymerization time"
576351|NCT00576420|E2|Reported Event|Fibrin Sealant - 120 Seconds|FS VH S/D 500 s-apr, 120 seconds polymerization time
576352|NCT00576420|E1|Reported Event|Fibrin Sealant - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
576353|NCT00576381|B1|Baseline|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
576354|NCT00576381|P1|Participant Flow|Neonatal Dose Escalation Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25 mcg/kg loading dose, 0.2 mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
576355|NCT00576381|O1|Outcome|Neonates|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25mcg/kg loading dose, 0.2mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
576356|NCT00576381|E1|Reported Event|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
576357|NCT00576316|B1|Baseline|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
576358|NCT00576316|P1|Participant Flow|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
576359|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
576360|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
576361|NCT00576316|E1|Reported Event|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
576388|NCT00576199|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576362|NCT00576303|B1|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576363|NCT00576303|P1|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the erythropoiesis stimulating agents (ESA) like epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
576364|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576365|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576366|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576367|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576368|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576369|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576370|NCT00576303|E1|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
576371|NCT00576251|B3|Baseline|Total|Total of all reporting groups
576372|NCT00576251|B2|Baseline|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
576373|NCT00576251|B1|Baseline|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
576374|NCT00576251|P2|Participant Flow|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
576375|NCT00576251|P1|Participant Flow|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
576376|NCT00576251|O2|Outcome|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
576377|NCT00576251|O1|Outcome|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
576378|NCT00576251|E2|Reported Event|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
576379|NCT00576251|E1|Reported Event|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
576380|NCT00576199|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576381|NCT00576199|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576382|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576383|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576384|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576385|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576386|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576387|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
576433|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576393|NCT00576056|B1|Baseline|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
576394|NCT00576056|P1|Participant Flow|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
576395|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
576396|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
576397|NCT00576056|E1|Reported Event|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
576398|NCT00575965|B1|Baseline|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
576399|NCT00575965|P1|Participant Flow|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
576400|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
576401|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
576402|NCT00575965|E1|Reported Event|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
576403|NCT00575887|B1|Baseline|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
576404|NCT00575887|P1|Participant Flow|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
576405|NCT00575887|O1|Outcome|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
576406|NCT00575887|E1|Reported Event|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
576407|NCT00575666|B3|Baseline|Total|Total of all reporting groups
576408|NCT00575666|B2|Baseline|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
576409|NCT00575666|B1|Baseline|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
576410|NCT00575666|P2|Participant Flow|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
576411|NCT00575666|P1|Participant Flow|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
576412|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576413|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576414|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576415|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576416|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576417|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576418|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576419|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576420|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576421|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576422|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576423|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576424|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576425|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576426|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576427|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576428|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576429|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576430|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576431|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576432|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576435|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576436|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576437|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576438|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576439|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576440|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576441|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576442|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576443|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576444|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
576445|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
576446|NCT00575666|E2|Reported Event|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
576447|NCT00575666|E1|Reported Event|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
576448|NCT00575588|B3|Baseline|Total|Total of all reporting groups
576449|NCT00575588|B2|Baseline|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576450|NCT00575588|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576451|NCT00575588|P2|Participant Flow|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576452|NCT00575588|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576453|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576454|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576455|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576456|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576457|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576458|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576459|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576460|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576461|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576462|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576463|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576464|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576465|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576466|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576467|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576468|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576469|NCT00575588|E2|Reported Event|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
576470|NCT00575588|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
576471|NCT00575510|B4|Baseline|Total|Total of all reporting groups
576472|NCT00575510|B3|Baseline|Standard Care Only|Clinical standard of care at time of study
576473|NCT00575510|B2|Baseline|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
576474|NCT00575510|B1|Baseline|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
576475|NCT00575510|P3|Participant Flow|Standard Care Only|Clinical standard of care at time of study
576476|NCT00575510|P2|Participant Flow|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
576477|NCT00575510|P1|Participant Flow|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
576478|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
576479|NCT00575510|O2|Outcome|Active Control|"non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
576480|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
576481|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
576482|NCT00575510|O2|Outcome|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
576483|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
576484|NCT00575510|E3|Reported Event|Standard Care Only|Clinical standard of care at time of study
576485|NCT00575510|E2|Reported Event|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
576486|NCT00575510|E1|Reported Event|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
576487|NCT00575380|B3|Baseline|Total|Total of all reporting groups
576488|NCT00575380|B2|Baseline|Vigamox|
576489|NCT00575380|B1|Baseline|Azasite|
576490|NCT00575380|P2|Participant Flow|Vigamox|
576491|NCT00575380|P1|Participant Flow|Azasite|
576492|NCT00575380|O2|Outcome|Vigamox|
576493|NCT00575380|O1|Outcome|Azasite|
576494|NCT00575380|O2|Outcome|Vigamox|
576495|NCT00575380|O1|Outcome|Azasite|
576496|NCT00575380|E2|Reported Event|Vigamox|
576497|NCT00575380|E1|Reported Event|Azasite|
576498|NCT00575367|B3|Baseline|Total|Total of all reporting groups
576499|NCT00575367|B2|Baseline|Vigamox|
576500|NCT00575367|B1|Baseline|AzaSite|
576501|NCT00575367|P2|Participant Flow|Vigamox|
576502|NCT00575367|P1|Participant Flow|AzaSite|
576503|NCT00575367|O2|Outcome|Vigamox|
576504|NCT00575367|O1|Outcome|AzaSite|
576505|NCT00575367|E2|Reported Event|Vigamox|
576506|NCT00575367|E1|Reported Event|AzaSite|
576507|NCT00575185|B3|Baseline|Total|Total of all reporting groups
576508|NCT00575185|B2|Baseline|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
576509|NCT00575185|B1|Baseline|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
576510|NCT00575185|P2|Participant Flow|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
576511|NCT00575185|P1|Participant Flow|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
576512|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo: Placebo tablets orally twice daily for 21 days."
576513|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir: 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
576514|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
576515|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
576516|NCT00575185|E2|Reported Event|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
576517|NCT00575185|E1|Reported Event|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
576518|NCT00575159|B1|Baseline|Overall Study Arm|Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin [continuous subcutaneous insulin injection (CSII)], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 mg tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant’s usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm.
576519|NCT00575159|P1|Participant Flow|Overall Study Arm|Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin [continuous subcutaneous insulin injection (CSII)], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 milligram (mg) tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant’s usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm.
576520|NCT00575159|O3|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576521|NCT00575159|O2|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576522|NCT00575159|O1|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
577313|NCT00573261|O1|Outcome|Placebo|Placebo
576523|NCT00575159|O3|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576524|NCT00575159|O2|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576525|NCT00575159|O1|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576526|NCT00575159|O3|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576527|NCT00575159|O2|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576528|NCT00575159|O1|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576529|NCT00575159|O3|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576530|NCT00575159|O2|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576531|NCT00575159|O1|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576532|NCT00575159|O3|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576533|NCT00575159|O2|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576534|NCT00575159|O1|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576648|NCT00575016|B3|Baseline|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
576649|NCT00575016|B2|Baseline|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
576535|NCT00575159|O3|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576536|NCT00575159|O2|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576537|NCT00575159|O1|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576538|NCT00575159|O3|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576539|NCT00575159|O2|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576540|NCT00575159|O1|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576541|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576542|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576543|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576544|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576545|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576546|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576650|NCT00575016|B1|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
576547|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576548|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576549|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576550|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576551|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576552|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576553|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576554|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576555|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576556|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576557|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576558|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576651|NCT00575016|P4|Participant Flow|Placebo|Normal saline (placebo)
576559|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576560|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576561|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576562|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576563|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576564|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576565|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576566|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576567|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576568|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576569|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576570|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
577431|NCT00573157|B3|Baseline|Total|Total of all reporting groups
576571|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576572|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576573|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576574|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576575|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576576|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576577|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576578|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576579|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576580|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576581|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576582|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576652|NCT00575016|P3|Participant Flow|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
576583|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576584|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576585|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576586|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576587|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576588|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576589|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576590|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576591|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576592|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576593|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576594|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576653|NCT00575016|P2|Participant Flow|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
576595|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576596|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576597|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576598|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576599|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576600|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576601|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576602|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576603|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576604|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576605|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576606|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576654|NCT00575016|P1|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
576607|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576608|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576609|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576610|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576611|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576612|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576613|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576614|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576615|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576616|NCT00575159|O5|Outcome|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576617|NCT00575159|O4|Outcome|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576618|NCT00575159|O3|Outcome|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576655|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
576619|NCT00575159|O2|Outcome|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576620|NCT00575159|O1|Outcome|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250 milliliter (mL) of water.
576621|NCT00575159|E5|Reported Event|GSK189075 500mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 500 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576622|NCT00575159|E4|Reported Event|GSK189075 150mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 150 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576623|NCT00575159|E3|Reported Event|GSK189075 50mg|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and GSK189075 50 mg tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576624|NCT00575159|E2|Reported Event|Placebo+ Prandial Insulin|Participants received a single dose of Basal insulin (CSII), mealtime bolus insulin injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576625|NCT00575159|E1|Reported Event|Placebo|Participants received a single dose of Basal insulin (CSII), mealtime placebo injection and matching GSK189075 placebo tablet. On Day 1, all study doses and mealtime insulin boluses were administered 15 minutes before the Participant begins to eat the scheduled meal (on dosing day, breakfast was the oral glucose load; lunch was the standard meal). On Day -1 (day prior to dosing day), basal insulin and insulin boluses before each meal were administered by the continuous insulin infusion pump. Study medication was administered orally in a fasted state before breakfast with 250mL of water.
576626|NCT00575146|B1|Baseline|Ketogenic Diet|ketogenic diet
576627|NCT00575146|P1|Participant Flow|Ketogenic Diet|unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin
576628|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
576629|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
576630|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
576631|NCT00575146|E1|Reported Event|Ketogenic Diet|ketogenic diet
576632|NCT00575094|B1|Baseline|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
576633|NCT00575094|P1|Participant Flow|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
576634|NCT00575094|O1|Outcome|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
576635|NCT00575094|E1|Reported Event|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
576636|NCT00575042|B1|Baseline|Patients Treated With Fenofibrate|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
576637|NCT00575042|P1|Participant Flow|Fenofibrate 160 mg Per Day|Fenofibrate (Insoluble Drug Deliver-Micro Particle Fenofibrate (IDD-P)) 160 mg per day
576638|NCT00575042|O2|Outcome|Patients Treated With Fenofibrate|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
576639|NCT00575042|O1|Outcome|Patients Before Treatment With Fenofibrate|Patients with previous incomplete response to UDCA
576640|NCT00575042|E1|Reported Event|Patients Treated With Fenofibrate|Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg per day
576641|NCT00575029|B1|Baseline|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
576642|NCT00575029|P1|Participant Flow|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
576643|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
576644|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
576645|NCT00575029|E1|Reported Event|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
576646|NCT00575016|B5|Baseline|Total|Total of all reporting groups
576647|NCT00575016|B4|Baseline|Placebo|Normal saline (placebo)
576656|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
576657|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
576658|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
576659|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
576660|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
576661|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
576662|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
576663|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
576664|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
576665|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
576666|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
576667|NCT00575016|E4|Reported Event|Placebo|Normal saline (placebo)
576668|NCT00575016|E3|Reported Event|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
576669|NCT00575016|E2|Reported Event|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
576670|NCT00575016|E1|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
576671|NCT00574990|B4|Baseline|Total|Total of all reporting groups
576672|NCT00574990|B3|Baseline|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576673|NCT00574990|B2|Baseline|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576674|NCT00574990|B1|Baseline|VA Physicians|VA physicians who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576675|NCT00574990|P3|Participant Flow|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576676|NCT00574990|P2|Participant Flow|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576677|NCT00574990|P1|Participant Flow|VA Physicians|VA Physicians who have spent at least one year in the VA and be familiar with the VA's electronic health record, CPRS.
576678|NCT00574990|O3|Outcome|VA Pharmacists|VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576679|NCT00574990|O2|Outcome|VA Nurses|VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576680|NCT00574990|O1|Outcome|VA Physicians|VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576681|NCT00574990|O3|Outcome|Pharmacists|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576682|NCT00574990|O2|Outcome|Nurses|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576683|NCT00574990|O1|Outcome|Physicians|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
576684|NCT00574990|E3|Reported Event|VA Pharmacists|VA Pharmacists who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
576685|NCT00574990|E2|Reported Event|VA Nurses|VA Nurses who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
576686|NCT00574990|E1|Reported Event|VA Physicians|VA Physicians who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
576687|NCT00574951|B1|Baseline|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576688|NCT00574951|P1|Participant Flow|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576689|NCT00574951|O1|Outcome|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576690|NCT00574951|O1|Outcome|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576691|NCT00574951|O1|Outcome|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576692|NCT00574951|O1|Outcome|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576693|NCT00574951|O1|Outcome|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576694|NCT00574951|E1|Reported Event|AMG 706|AMG 706 125 mg PO daily continuously (one cycle is 28 days) until disease progression or adverse effects prohibit further therapy
576695|NCT00574912|B1|Baseline|1--All Interventions|"Arm: Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
576696|NCT00574912|P1|Participant Flow|1 All Interventions|"Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
576697|NCT00574912|O5|Outcome|2.0 Units of Glargine/kg|maximum glucose infusion rate
576698|NCT00574912|O4|Outcome|1.5 Units of Glargine/kg|maximum glucose infusion rate
576699|NCT00574912|O3|Outcome|1.0 Units of Glargine/kg|maximum glucose infusion rate
576700|NCT00574912|O2|Outcome|0.5 Units of Glargine/kg|maximum glucose infusion rate
576701|NCT00574912|O1|Outcome|Placebo|Maximum glucose infusion rate
576702|NCT00574912|E5|Reported Event|2.0 Units of Glargine/kg Body Weight|"2.0 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
576833|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
576703|NCT00574912|E4|Reported Event|1.5 Units of Glargine/kg Body Weight|"1.5 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
576704|NCT00574912|E3|Reported Event|1 Unit of Glargine/kg Body Weight|"1 unit of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
576705|NCT00574912|E2|Reported Event|0.5 Units of Glargine/kg Body Weight|"0.5 units of Glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
576706|NCT00574912|E1|Reported Event|Placebo|"Placebo~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
576707|NCT00574873|B3|Baseline|Total|Total of all reporting groups
576708|NCT00574873|B2|Baseline|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576709|NCT00574873|B1|Baseline|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576710|NCT00574873|P2|Participant Flow|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576711|NCT00574873|P1|Participant Flow|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576712|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576713|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576714|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576715|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576716|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576717|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576718|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576719|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576720|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576721|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576722|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576723|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576724|NCT00574873|E2|Reported Event|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
576725|NCT00574873|E1|Reported Event|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
576726|NCT00574847|B3|Baseline|Total|Total of all reporting groups
576796|NCT00574704|P4|Participant Flow|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576727|NCT00574847|B2|Baseline|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576728|NCT00574847|B1|Baseline|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576729|NCT00574847|P2|Participant Flow|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576730|NCT00574847|P1|Participant Flow|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576731|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576732|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576733|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576734|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576735|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576736|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576737|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576738|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576739|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576740|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576741|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576742|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576743|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576744|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576745|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576746|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576747|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576748|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576749|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576750|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576751|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576752|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576753|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576754|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576755|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576756|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
578329|NCT00570492|B3|Baseline|Total|Total of all reporting groups
576757|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576758|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576759|NCT00574847|E2|Reported Event|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576760|NCT00574847|E1|Reported Event|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
576761|NCT00574834|B4|Baseline|Total|Total of all reporting groups
576762|NCT00574834|B3|Baseline|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
576763|NCT00574834|B2|Baseline|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
576764|NCT00574834|B1|Baseline|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
576765|NCT00574834|P3|Participant Flow|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
576766|NCT00574834|P2|Participant Flow|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
576767|NCT00574834|P1|Participant Flow|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
576768|NCT00574834|O3|Outcome|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
576769|NCT00574834|O2|Outcome|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
576770|NCT00574834|O1|Outcome|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
576771|NCT00574834|E3|Reported Event|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
576772|NCT00574834|E2|Reported Event|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
576773|NCT00574834|E1|Reported Event|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
576774|NCT00574795|B1|Baseline|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
576775|NCT00574795|P1|Participant Flow|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
576776|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
576777|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
576778|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
576779|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
576780|NCT00574795|O3|Outcome|13vPnC Dose 3|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
576781|NCT00574795|O2|Outcome|13vPnC Dose 2|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
576782|NCT00574795|O1|Outcome|13vPnC Dose 1|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
576783|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
576784|NCT00574795|O3|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
576785|NCT00574795|O2|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
576786|NCT00574795|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
576787|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
576788|NCT00574795|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).
576789|NCT00574795|E2|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
576790|NCT00574795|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
576791|NCT00574704|B5|Baseline|Total|Total of all reporting groups
576792|NCT00574704|B4|Baseline|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576793|NCT00574704|B3|Baseline|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576794|NCT00574704|B2|Baseline|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
576795|NCT00574704|B1|Baseline|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
576797|NCT00574704|P3|Participant Flow|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576798|NCT00574704|P2|Participant Flow|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
576799|NCT00574704|P1|Participant Flow|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
576800|NCT00574704|O4|Outcome|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576801|NCT00574704|O3|Outcome|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576802|NCT00574704|O2|Outcome|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
576803|NCT00574704|O1|Outcome|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
576804|NCT00574704|E4|Reported Event|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576805|NCT00574704|E3|Reported Event|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
576806|NCT00574704|E2|Reported Event|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
576807|NCT00574704|E1|Reported Event|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
576808|NCT00574548|B3|Baseline|Total|Total of all reporting groups
576809|NCT00574548|B2|Baseline|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576810|NCT00574548|B1|Baseline|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576811|NCT00574548|P2|Participant Flow|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576812|NCT00574548|P1|Participant Flow|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576813|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576814|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576815|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576816|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576817|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
576818|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576819|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576820|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576821|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576822|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
576823|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576824|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576825|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576826|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576827|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576828|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
576829|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576830|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576831|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576832|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
581595|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
576834|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576835|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576836|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576837|NCT00574548|O2|Outcome|13vPnC / 23vPS Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576838|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576839|NCT00574548|O2|Outcome|13vPnC / 13vPnC Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576840|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
576841|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576842|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576843|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
576844|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
576845|NCT00574548|E10|Reported Event|23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576846|NCT00574548|E9|Reported Event|13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
576847|NCT00574548|E8|Reported Event|13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576848|NCT00574548|E7|Reported Event|23vPS / 13vPnC (Year 1)|"23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68."
576849|NCT00574548|E6|Reported Event|13vPnC / 23vPS (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120."
576850|NCT00574548|E5|Reported Event|13vPnC / 13vPnC (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54."
576851|NCT00574548|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1 (Year 0)|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
576852|NCT00574548|E3|Reported Event|13vPnC: 6 Month Follow-up After Vax 1 (Year 0)|Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
576853|NCT00574548|E2|Reported Event|23vPS (Year 0)|"Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86."
576854|NCT00574548|E1|Reported Event|13vPnC (Year 0)|"Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163."
576855|NCT00574405|B3|Baseline|Total|Total of all reporting groups
576856|NCT00574405|B2|Baseline|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
576857|NCT00574405|B1|Baseline|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
576858|NCT00574405|P2|Participant Flow|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
576859|NCT00574405|P1|Participant Flow|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
576860|NCT00574405|O2|Outcome|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
577197|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
576861|NCT00574405|O1|Outcome|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
576862|NCT00574405|E2|Reported Event|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
576863|NCT00574405|E1|Reported Event|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
576864|NCT00574340|B1|Baseline|All Study Participants|
576865|NCT00574340|P2|Participant Flow|Antecedent Hypoglycemia Group Then Control Study|Day 1 hypoglycemia, Day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, day 2 hypoglycemia
576866|NCT00574340|P1|Participant Flow|Control Study Then Antecedent Hypoglycemia Study Group|Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
576867|NCT00574340|O2|Outcome|Antecedent Hypoglycemia Group|"Day 1 hypoglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
576868|NCT00574340|O1|Outcome|Control Group|"Day 1 euglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
576869|NCT00574340|E2|Reported Event|Antecedent Hypoglycemia Group-all Participants|"Day 1 hypoglycemia, day 2 hypoglycemia= one study~Hyperinsulinemic Hypoglycemic Clamp study: each two day study (arm) separated by 8 weeks"
576870|NCT00574340|E1|Reported Event|Control Group- All Participants|"Day 1 euglycemia, day 2 hypoglycemia= one study~Hyperinsulinemic Euglycemic Clamp study: each two day study (arm) separated by 8 weeks"
576871|NCT00574288|B8|Baseline|Total|Total of all reporting groups
576872|NCT00574288|B7|Baseline|Part 2 - 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576873|NCT00574288|B6|Baseline|Part 2 - 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576874|NCT00574288|B5|Baseline|Part 1 - 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576875|NCT00574288|B4|Baseline|Part 1 - 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576876|NCT00574288|B3|Baseline|Part 1 - 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576877|NCT00574288|B2|Baseline|Part 1 - 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576878|NCT00574288|B1|Baseline|Part 1 - <4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576879|NCT00574288|P7|Participant Flow|Part 2 - 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576880|NCT00574288|P6|Participant Flow|Part 2 - 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576881|NCT00574288|P5|Participant Flow|Part 1 - 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576882|NCT00574288|P4|Participant Flow|Part 1 - 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
577198|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
576883|NCT00574288|P3|Participant Flow|Part 1 - 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576884|NCT00574288|P2|Participant Flow|Part 1 - 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576885|NCT00574288|P1|Participant Flow|Part 1 - <4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576886|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576887|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576888|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576889|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576890|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576891|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576892|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576893|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576894|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576895|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576896|NCT00574288|O4|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576897|NCT00574288|O3|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
581596|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
576898|NCT00574288|O2|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions.
576899|NCT00574288|O1|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576900|NCT00574288|O6|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576901|NCT00574288|O5|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576902|NCT00574288|O4|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576903|NCT00574288|O3|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576904|NCT00574288|O2|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576905|NCT00574288|O1|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576906|NCT00574288|O7|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576907|NCT00574288|O6|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576908|NCT00574288|O5|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576909|NCT00574288|O4|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576910|NCT00574288|O3|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576911|NCT00574288|O2|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576912|NCT00574288|O1|Outcome|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576913|NCT00574288|E7|Reported Event|Part 2 - 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576935|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576914|NCT00574288|E6|Reported Event|Part 2 - 8 mg/kg|Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
576915|NCT00574288|E5|Reported Event|Part 1 - 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576916|NCT00574288|E4|Reported Event|Part 1 - 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576917|NCT00574288|E3|Reported Event|Part 1 - 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576918|NCT00574288|E2|Reported Event|Part 1 - 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576919|NCT00574288|E1|Reported Event|Part 1 - <4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
576920|NCT00574275|B3|Baseline|Total|Total of all reporting groups
576921|NCT00574275|B2|Baseline|Aflibercept/Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576922|NCT00574275|B1|Baseline|Placebo/Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576923|NCT00574275|P2|Participant Flow|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576924|NCT00574275|P1|Participant Flow|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576925|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576926|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576927|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576928|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576929|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576930|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576931|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576932|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576933|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576934|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576936|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576937|NCT00574275|E2|Reported Event|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576938|NCT00574275|E1|Reported Event|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
576939|NCT00574249|B3|Baseline|Total|Total of all reporting groups
576940|NCT00574249|B2|Baseline|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576941|NCT00574249|B1|Baseline|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576942|NCT00574249|P2|Participant Flow|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
576943|NCT00574249|P1|Participant Flow|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
576944|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576945|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576946|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576947|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576948|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576949|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576950|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576951|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576952|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576953|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576954|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576955|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576956|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576957|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576958|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576959|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576960|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576961|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576962|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576963|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576964|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576965|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576966|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576995|NCT00574145|P1|Participant Flow|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
576967|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576968|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576969|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576970|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576971|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576972|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576973|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576974|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576975|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576976|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576977|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576978|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576979|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576980|NCT00574249|E2|Reported Event|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
576981|NCT00574249|E1|Reported Event|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
576982|NCT00574236|B1|Baseline|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
576983|NCT00574236|P1|Participant Flow|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
576984|NCT00574236|O1|Outcome|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
576985|NCT00574236|O1|Outcome|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
576986|NCT00574236|E1|Reported Event|Bortezomib and Doxorubicin|Subjects received therapy on days 1, 4, 8, and 11 of a 21-day cycle. 1.3 mg/m2 of Bortezomib was administered intravenously over 3-5 seconds on days 1, 4, 8, and 11, no less than 72 hours apart. 20 mg/m2 of Doxorubicin was administered intravenously over 3-5 minutes on days 1 and 8, one hour after Bortezomib administrations.
576987|NCT00574171|B1|Baseline|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
576988|NCT00574171|P1|Participant Flow|Lapatinib and Capecitabine|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
576989|NCT00574171|O1|Outcome|Lapatinib/Capecitabine|lapatinib: 1250mg by mouth daily one hour before or after breakfast on a continuous basis. Capecitabine: 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
576990|NCT00574171|E1|Reported Event|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
576991|NCT00574145|B3|Baseline|Total|Total of all reporting groups
576992|NCT00574145|B2|Baseline|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
576993|NCT00574145|B1|Baseline|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
576994|NCT00574145|P2|Participant Flow|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
577199|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
576996|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
576997|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
576998|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
576999|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
577000|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
577001|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
577002|NCT00574145|E2|Reported Event|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
577003|NCT00574145|E1|Reported Event|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
577004|NCT00574080|B3|Baseline|Total|Total of all reporting groups
577005|NCT00574080|B2|Baseline|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
577006|NCT00574080|B1|Baseline|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
577007|NCT00574080|P2|Participant Flow|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
577008|NCT00574080|P1|Participant Flow|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
577009|NCT00574080|O2|Outcome|Arm B|
577010|NCT00574080|O1|Outcome|Arm A|
577011|NCT00574080|E2|Reported Event|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
577012|NCT00574080|E1|Reported Event|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
577013|NCT00574067|B5|Baseline|Total|Total of all reporting groups
577014|NCT00574067|B4|Baseline|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577015|NCT00574067|B3|Baseline|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577016|NCT00574067|B2|Baseline|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577017|NCT00574067|B1|Baseline|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577018|NCT00574067|P4|Participant Flow|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577019|NCT00574067|P3|Participant Flow|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577020|NCT00574067|P2|Participant Flow|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577021|NCT00574067|P1|Participant Flow|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577022|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577023|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577024|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577025|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577026|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577027|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577028|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577029|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577030|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577031|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577032|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577033|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577034|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577035|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577036|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577037|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577038|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577039|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577040|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577041|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577042|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577043|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577044|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577045|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577200|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
577046|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577047|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577048|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577049|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577050|NCT00574067|E4|Reported Event|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577051|NCT00574067|E3|Reported Event|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577052|NCT00574067|E2|Reported Event|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
577053|NCT00574067|E1|Reported Event|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
577054|NCT00573937|B3|Baseline|Total|Total of all reporting groups
577055|NCT00573937|B2|Baseline|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
577056|NCT00573937|B1|Baseline|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
577057|NCT00573937|P2|Participant Flow|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
577058|NCT00573937|P1|Participant Flow|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
577059|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
577060|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
577061|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
577062|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
577063|NCT00573937|E2|Reported Event|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
577064|NCT00573937|E1|Reported Event|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
577065|NCT00573872|B1|Baseline|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
577066|NCT00573872|P1|Participant Flow|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
577077|NCT00573833|B1|Baseline|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
577078|NCT00573833|P1|Participant Flow|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
577079|NCT00573833|O1|Outcome|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
577201|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
577067|NCT00573872|O1|Outcome|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
577068|NCT00573872|O1|Outcome|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
577069|NCT00573872|O1|Outcome|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
577070|NCT00573872|E1|Reported Event|Spinal Radiosurgery|"Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.~Radiosurgery: Phase I: 20-25 Gy in 5 fractions~Phase II: 9-24 GY in 1 fraction"
577071|NCT00573859|B1|Baseline|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
577072|NCT00573859|P1|Participant Flow|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
577073|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
577074|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
577075|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
577076|NCT00573859|E1|Reported Event|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
577568|NCT00572897|B1|Baseline|Sibling Donor|Patients received a stem cell transplant from sibling
577080|NCT00573833|O1|Outcome|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
577081|NCT00573833|O1|Outcome|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
577082|NCT00573833|O1|Outcome|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
577083|NCT00573833|E1|Reported Event|HDR Brachytherapy|"9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days~questionnaire administration~quality-of-life assessment~brachytherapy"
577084|NCT00573794|B1|Baseline|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577085|NCT00573794|P1|Participant Flow|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577086|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577087|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577088|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577089|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577090|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577091|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577092|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577093|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577094|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577095|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577096|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577097|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577098|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577099|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577100|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577101|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577102|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577103|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577104|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577105|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577106|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577107|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577108|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577109|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577110|NCT00573794|O1|Outcome|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577111|NCT00573794|E1|Reported Event|Adalimumab 40 mg EOW/EW|Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
577112|NCT00573768|B4|Baseline|Total|Total of all reporting groups
577113|NCT00573768|B3|Baseline|Vehicle Gel|BID application
577114|NCT00573768|B2|Baseline|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
577115|NCT00573768|B1|Baseline|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
577116|NCT00573768|P3|Participant Flow|Vehicle Gel|BID application
577117|NCT00573768|P2|Participant Flow|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
577118|NCT00573768|P1|Participant Flow|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
577119|NCT00573768|O3|Outcome|Vehicle Gel|BID application
577120|NCT00573768|O2|Outcome|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
577121|NCT00573768|O1|Outcome|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
577122|NCT00573768|E3|Reported Event|Vehicle Gel|BID application
577123|NCT00573768|E2|Reported Event|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
577124|NCT00573768|E1|Reported Event|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
577125|NCT00573755|B3|Baseline|Total|Total of all reporting groups
577126|NCT00573755|B2|Baseline|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577127|NCT00573755|B1|Baseline|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577128|NCT00573755|P2|Participant Flow|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577129|NCT00573755|P1|Participant Flow|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577130|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577131|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577132|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577133|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577134|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577135|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577136|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577137|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577196|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
581597|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
577138|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577139|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577140|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577141|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577142|NCT00573755|E2|Reported Event|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577143|NCT00573755|E1|Reported Event|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
577144|NCT00573534|B1|Baseline|Group 1|Adolescents with ADHD and an older sibling with substance use disorder
577145|NCT00573534|P1|Participant Flow|Group 1|Adolescents with ADHD and an older sibling with Substance Use Disorder
577146|NCT00573534|O1|Outcome|Lisdexamfetamine Plus Family Therapy|patients received lisdexamfetamine up to 70 mgs plus family counseling
577147|NCT00573534|O1|Outcome|Group 1|Lisdexamfetamine and family counseling
577148|NCT00573534|E1|Reported Event|Group 1|Intervention with Vyvanse
577149|NCT00573508|B3|Baseline|Total|Total of all reporting groups
577150|NCT00573508|B2|Baseline|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577151|NCT00573508|B1|Baseline|Placebo|Matching placebo tablet taken once daily
577152|NCT00573508|P2|Participant Flow|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577153|NCT00573508|P1|Participant Flow|Placebo|Matching placebo tablet taken once daily
577154|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577155|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577156|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577157|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577158|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577159|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577160|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577161|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577162|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577163|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577164|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577165|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577166|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577167|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577168|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577169|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577170|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577171|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577172|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577173|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577174|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577175|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577176|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577177|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577178|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577179|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
577180|NCT00573508|E2|Reported Event|Solifenacin Succinate|5mg or 10mg tablet taken once daily
577181|NCT00573508|E1|Reported Event|Placebo|Matching placebo tablet taken once daily
577182|NCT00573469|B4|Baseline|Total|Total of all reporting groups
577183|NCT00573469|B3|Baseline|Placebo|An enteric capsule without D9421-C was given once daily.
577184|NCT00573469|B2|Baseline|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
577185|NCT00573469|B1|Baseline|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
577186|NCT00573469|P3|Participant Flow|Placebo|An enteric capsule without D9421-C was given once daily.
577187|NCT00573469|P2|Participant Flow|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
577188|NCT00573469|P1|Participant Flow|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
577189|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
577190|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
577191|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
577192|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
577193|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
577194|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
577195|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
577202|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
577203|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
577204|NCT00573469|E3|Reported Event|Placebo|An enteric capsule without D9421-C was given once daily.
577205|NCT00573469|E2|Reported Event|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
577206|NCT00573469|E1|Reported Event|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
577207|NCT00573443|B4|Baseline|Total|Total of all reporting groups
577208|NCT00573443|B3|Baseline|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577209|NCT00573443|B2|Baseline|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577210|NCT00573443|B1|Baseline|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577211|NCT00573443|P3|Participant Flow|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577212|NCT00573443|P2|Participant Flow|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577213|NCT00573443|P1|Participant Flow|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577214|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577215|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577216|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577217|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577218|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577219|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577220|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577221|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577222|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577223|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577224|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577265|NCT00573391|B2|Baseline|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
581598|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
577225|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577226|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577227|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577228|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577229|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577230|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577231|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577232|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577233|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577234|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
577235|NCT00573443|E4|Reported Event|AVP-923-30 (Open Label)|Optional 12-week Open Label phase for subjects who completed 12-week DB phase.
577236|NCT00573443|E3|Reported Event|Placebo (Double-blind)|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
577237|NCT00573443|E2|Reported Event|AVP-923-20 (Double-blind)|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
577238|NCT00573443|E1|Reported Event|AVP-923-30 (Double-blind)|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period.
577239|NCT00573430|B4|Baseline|Total|Total of all reporting groups
577240|NCT00573430|B3|Baseline|Candesartan 32mg|Candesartan 32mg oral once daily dose
577241|NCT00573430|B2|Baseline|Candesartan 16mg|Candesartan 16mg oral once daily dose
577242|NCT00573430|B1|Baseline|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577243|NCT00573430|P3|Participant Flow|Candesartan 32mg|Candesartan 32mg oral once daily dose
577244|NCT00573430|P2|Participant Flow|Candesartan 16mg|Candesartan 16mg oral once daily dose
577245|NCT00573430|P1|Participant Flow|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577246|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
577247|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
577248|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577249|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
577250|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
577251|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577252|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
577253|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
577254|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577255|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
577256|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
577257|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577258|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
577259|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
577260|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577261|NCT00573430|E3|Reported Event|Candesartan 32mg|Candesartan 32mg oral once daily dose
577262|NCT00573430|E2|Reported Event|Candesartan 16mg|Candesartan 16mg oral once daily dose
577263|NCT00573430|E1|Reported Event|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
577264|NCT00573391|B3|Baseline|Total|Total of all reporting groups
577266|NCT00573391|B1|Baseline|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
577267|NCT00573391|P2|Participant Flow|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
577268|NCT00573391|P1|Participant Flow|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
577269|NCT00573391|O2|Outcome|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
577270|NCT00573391|O1|Outcome|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
577271|NCT00573391|E2|Reported Event|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
577272|NCT00573391|E1|Reported Event|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
577273|NCT00573313|B5|Baseline|Total|Total of all reporting groups
577274|NCT00573313|B4|Baseline|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
577275|NCT00573313|B3|Baseline|Lifestyle Counseling|Active drinkers non liver disease subjects
577276|NCT00573313|B2|Baseline|Healthy|Healthy subjects without alcoholism or liver disease.
577277|NCT00573313|B1|Baseline|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
577278|NCT00573313|P4|Participant Flow|Lifestyle Counseling|Subjects were enrolled into this arm for baseline measurements only.
577279|NCT00573313|P3|Participant Flow|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
577280|NCT00573313|P2|Participant Flow|Healthy|Subjects were enrolled into this arm for baseline measurement only.
577281|NCT00573313|P1|Participant Flow|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
577282|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving placebo sugar pill three times daily for 24 weeks.
577283|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
577284|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
577285|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
577286|NCT00573313|E2|Reported Event|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
577287|NCT00573313|E1|Reported Event|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
577288|NCT00573287|B3|Baseline|Total|Total of all reporting groups
577289|NCT00573287|B2|Baseline|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
577290|NCT00573287|B1|Baseline|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
577291|NCT00573287|P2|Participant Flow|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
577292|NCT00573287|P1|Participant Flow|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
577293|NCT00573287|O2|Outcome|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
577294|NCT00573287|O1|Outcome|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
577295|NCT00573287|E2|Reported Event|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
577296|NCT00573287|E1|Reported Event|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
577297|NCT00573261|B3|Baseline|Total|Total of all reporting groups
577298|NCT00573261|B2|Baseline|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577299|NCT00573261|B1|Baseline|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577300|NCT00573261|P2|Participant Flow|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577301|NCT00573261|P1|Participant Flow|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577302|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
577303|NCT00573261|O1|Outcome|Placebo|Placebo
577304|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
577305|NCT00573261|O1|Outcome|Placebo|Placebo
577306|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577307|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577308|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577309|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577310|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577311|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577312|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
577314|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577315|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577316|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
577317|NCT00573261|O1|Outcome|Placebo|Placebo
577318|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
577319|NCT00573261|O1|Outcome|Placebo|Placebo
577320|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
577321|NCT00573261|O1|Outcome|Placebo|Placebo
577322|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
577323|NCT00573261|O1|Outcome|Placebo|Placebo
577324|NCT00573261|E2|Reported Event|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577325|NCT00573261|E1|Reported Event|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
577326|NCT00573248|B3|Baseline|Total|Total of all reporting groups
577327|NCT00573248|B2|Baseline|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
577328|NCT00573248|B1|Baseline|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
577329|NCT00573248|P2|Participant Flow|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
577330|NCT00573248|P1|Participant Flow|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
577331|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
577332|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
577333|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
577334|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
577335|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
577336|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
577337|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
577338|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
577339|NCT00573248|E2|Reported Event|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
577340|NCT00573248|E1|Reported Event|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
577341|NCT00573183|B3|Baseline|Total|Total of all reporting groups
577342|NCT00573183|B2|Baseline|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
577343|NCT00573183|B1|Baseline|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
577344|NCT00573183|P2|Participant Flow|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
577345|NCT00573183|P1|Participant Flow|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
577346|NCT00573183|O2|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
577347|NCT00573183|O1|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
577348|NCT00573183|O2|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
577349|NCT00573183|O1|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
577350|NCT00573183|E2|Reported Event|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
577351|NCT00573183|E1|Reported Event|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
577352|NCT00573170|B1|Baseline|All Study Participants Treated at Least Once|All study participants who were treated at least once with study medication
577380|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577381|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577382|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577353|NCT00573170|P6|Participant Flow|Placebo, Butalbital-containing Combo. Medication, Treximet|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
577354|NCT00573170|P5|Participant Flow|Placebo, Treximet, Butalbital-containing Combo. Medication|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
577355|NCT00573170|P4|Participant Flow|Butalbital-containing Combo. Medication, Placebo, Treximet|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
577356|NCT00573170|P3|Participant Flow|Butalbital-containing Combo. Medication, Treximet, Placebo|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
577357|NCT00573170|P2|Participant Flow|Treximet, Butalbital-containing Combo. Medication, Placebo|Fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
577358|NCT00573170|P1|Participant Flow|Treximet, Placebo, Butalbital-containing Combo. Medication|Fixed dose combination (combo.) tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
577359|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577360|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577361|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577362|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577363|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577364|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577365|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577366|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577367|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577368|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577369|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577370|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577371|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577372|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577373|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577374|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577375|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577376|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577377|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577378|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577379|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577383|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577384|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577385|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577386|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577387|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577388|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577389|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577390|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577391|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577392|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577393|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577394|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577395|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577396|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577397|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577398|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577399|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577400|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577401|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577402|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577403|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577404|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577405|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577406|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577407|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577408|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577409|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577410|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Butalbital-containing combination medication
577411|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Treximet
577412|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with placebo
577413|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Butalbital-containing combination medication
577414|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Treximet
577415|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with placebo
577416|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Butalbital-containing combination medication
577417|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Treximet
577418|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with placebo
577419|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577420|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577421|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577422|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577423|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577424|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577425|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
577426|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
577427|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
577428|NCT00573170|E3|Reported Event|Butalbital-containing Combination Medication|Participants who reported an SAE anytime after initial treatment with blinded Butalbital-containing combination medication, but before another initial treatment with any other investigational product
577429|NCT00573170|E2|Reported Event|Treximet|Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product
577430|NCT00573170|E1|Reported Event|Placebo|Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product
577432|NCT00573157|B2|Baseline|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577433|NCT00573157|B1|Baseline|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577434|NCT00573157|P2|Participant Flow|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577435|NCT00573157|P1|Participant Flow|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577436|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577437|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577438|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577439|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577440|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577441|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577442|NCT00573157|E2|Reported Event|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577474|NCT00572936|P3|Participant Flow|Dorzolamide/Latanoprost/Timolol|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
577567|NCT00572897|B2|Baseline|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577443|NCT00573157|E1|Reported Event|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
577444|NCT00573144|B3|Baseline|Total|Total of all reporting groups
577445|NCT00573144|B2|Baseline|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
577446|NCT00573144|B1|Baseline|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
577447|NCT00573144|P2|Participant Flow|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
577448|NCT00573144|P1|Participant Flow|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
577449|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
577450|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
577451|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
577452|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
577453|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
577454|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
577455|NCT00573144|E2|Reported Event|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
577456|NCT00573144|E1|Reported Event|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
577457|NCT00573131|B3|Baseline|Total|Total of all reporting groups
577458|NCT00573131|B2|Baseline|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577459|NCT00573131|B1|Baseline|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577460|NCT00573131|P2|Participant Flow|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577461|NCT00573131|P1|Participant Flow|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577462|NCT00573131|O2|Outcome|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577463|NCT00573131|O1|Outcome|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577464|NCT00573131|E2|Reported Event|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577465|NCT00573131|E1|Reported Event|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
577466|NCT00573066|B1|Baseline|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
577467|NCT00573066|P1|Participant Flow|Dexmedetomidine Dose Escalation Cohorts|"Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
577468|NCT00573066|O1|Outcome|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
577469|NCT00573066|E1|Reported Event|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
577470|NCT00572936|B1|Baseline|Latanoprost/Dorzolamide/Timolol|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
577471|NCT00572936|P6|Participant Flow|Timolol/Latanoprost/Dorzolamide|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
577472|NCT00572936|P5|Participant Flow|Timolol/Dorzolamide/Latanoprost|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
577473|NCT00572936|P4|Participant Flow|Dorzolamide/Timolol/Latanoprost|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
577524|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
577475|NCT00572936|P2|Participant Flow|Latanoprost/Timolol/Dorzolamide|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
577476|NCT00572936|P1|Participant Flow|Latanoprost/Dorzolamide/Timolol|The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
577477|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577478|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577479|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577480|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577481|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577482|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577483|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577484|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577485|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577486|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577487|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577488|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577489|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577490|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577491|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577492|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577493|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577494|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577495|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577496|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577497|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577498|NCT00572936|O3|Outcome|Dorzolamide|The participants received dorzolamide 2% BID for two weeks
577499|NCT00572936|O2|Outcome|Timolol|The participants received timolol 0.5% BID for two weeks
577500|NCT00572936|O1|Outcome|Latanoprost|The participants received latanoprost 0.004% at night and vehicle in the morning for two weeks
577501|NCT00572936|E3|Reported Event|Timolol|Timolol BID for two weeks
577502|NCT00572936|E2|Reported Event|Dorzolamide|Dorzolamide BID for two weeks,
577503|NCT00572936|E1|Reported Event|Latanoprost|The participants received latanoprost at night and vehicle in the morning for two weeks,
577504|NCT00572910|B7|Baseline|Total|Total of all reporting groups
577505|NCT00572910|B6|Baseline|Placebo (PBO / PBO)|Participants who were vaccinated with Placebo on Day 1 and Day 28.
577506|NCT00572910|B5|Baseline|V710 (90 mcg / 90 mcg) + MAA|Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
577507|NCT00572910|B4|Baseline|V710 (60 mcg / PBO) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28.
577508|NCT00572910|B3|Baseline|V710 (60 mcg / 60 mcg) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
577509|NCT00572910|B2|Baseline|V710 (60 mcg / PBO)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28.
577510|NCT00572910|B1|Baseline|V710 (60 mcg / 60 mcg)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
577511|NCT00572910|P11|Participant Flow|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
577512|NCT00572910|P10|Participant Flow|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
577513|NCT00572910|P9|Participant Flow|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
577514|NCT00572910|P8|Participant Flow|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
577515|NCT00572910|P7|Participant Flow|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
577516|NCT00572910|P6|Participant Flow|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg /PBO) with MAA.
577517|NCT00572910|P5|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
577518|NCT00572910|P4|Participant Flow|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
577519|NCT00572910|P3|Participant Flow|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
577520|NCT00572910|P2|Participant Flow|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
577521|NCT00572910|P1|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
577522|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
577523|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
577566|NCT00572897|B3|Baseline|Total|Total of all reporting groups
577525|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
577526|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
577527|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
577528|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
577529|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
577530|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
577531|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
577532|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
577533|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
577534|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
577535|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
577536|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
577537|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
577538|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
577539|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
577540|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
577541|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
577542|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
577543|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
577544|NCT00572910|O2|Outcome|V710 - Group 4|Participants in Group 4 were vaccinated V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
577545|NCT00572910|O1|Outcome|V710 - Group 2|Participants in Group 2 were vaccinated V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
577546|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
577547|NCT00572910|O2|Outcome|V710 - Group 3|Participants in Group 2 were vaccinated V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
577548|NCT00572910|O1|Outcome|V710 - Group 1|Participants in Group 1 were vaccinated V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
577549|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
577550|NCT00572910|O2|Outcome|V710 - Group 3 and 4|"Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants in Group 4 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
577551|NCT00572910|O1|Outcome|V710 - Group 1 and 2|"Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants Group 2 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
577552|NCT00572910|O3|Outcome|V710 (90 mcg With MAA) - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
577553|NCT00572910|O2|Outcome|V710 (60 mcg With MAA) - Group 3|Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
577554|NCT00572910|O1|Outcome|V710 (60 mcg Without MAA) - Group 1|Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
577555|NCT00572910|E11|Reported Event|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
577556|NCT00572910|E10|Reported Event|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
577557|NCT00572910|E9|Reported Event|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
577558|NCT00572910|E8|Reported Event|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
577559|NCT00572910|E7|Reported Event|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
577560|NCT00572910|E6|Reported Event|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
577561|NCT00572910|E5|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
577562|NCT00572910|E4|Reported Event|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
577563|NCT00572910|E3|Reported Event|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
577564|NCT00572910|E2|Reported Event|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
577565|NCT00572910|E1|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
577569|NCT00572897|P2|Participant Flow|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577570|NCT00572897|P1|Participant Flow|Sibling Donor|Patients received a stem cell transplant from sibling
577571|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577572|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
577573|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577574|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
577575|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577576|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
577577|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577578|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
577579|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577580|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
577581|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577582|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
577583|NCT00572897|E2|Reported Event|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
577584|NCT00572897|E1|Reported Event|Sibling Donor|Patients received a stem cell transplant from sibling
577585|NCT00572832|B3|Baseline|Total|Total of all reporting groups
577586|NCT00572832|B2|Baseline|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
577587|NCT00572832|B1|Baseline|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
577588|NCT00572832|P2|Participant Flow|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
577589|NCT00572832|P1|Participant Flow|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
577590|NCT00572832|O2|Outcome|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
577591|NCT00572832|O1|Outcome|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
577592|NCT00572832|E2|Reported Event|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
577593|NCT00572832|E1|Reported Event|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
577594|NCT00572728|B1|Baseline|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577595|NCT00572728|P1|Participant Flow|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577596|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577597|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577598|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~CT: Undergo 18F-FLT PET/CT~18F-FLT: Undergo 18F-FLT PET/CT~PET: Undergo 18F-FLT PET/CT"
577599|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577600|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
578959|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
577601|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577602|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post-NAC (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577603|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577604|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577605|NCT00572728|E1|Reported Event|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
577606|NCT00572624|B3|Baseline|Total|Total of all reporting groups
577607|NCT00572624|B2|Baseline|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577608|NCT00572624|B1|Baseline|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577609|NCT00572624|P2|Participant Flow|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577610|NCT00572624|P1|Participant Flow|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577611|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577612|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577613|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577614|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577615|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577616|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577617|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577618|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577619|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577620|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577621|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577622|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577623|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577624|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577625|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577626|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577627|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577628|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577629|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577630|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577631|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577632|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577633|NCT00572624|E2|Reported Event|Gastric Bypass Surgery|Participants who received gastric bypass surgery
577634|NCT00572624|E1|Reported Event|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
577635|NCT00572572|B3|Baseline|Total|Total of all reporting groups
577636|NCT00572572|B2|Baseline|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
577685|NCT00572468|O1|Outcome|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
581599|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
577637|NCT00572572|B1|Baseline|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
577638|NCT00572572|P2|Participant Flow|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
577639|NCT00572572|P1|Participant Flow|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
577640|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
577641|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
577642|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
577643|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
577644|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
577645|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
577646|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
577647|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
577648|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
577649|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
577650|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
577651|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
577652|NCT00572572|E2|Reported Event|Placebo, Then Aprepitant.|"Arm A, Study Cycle 2~Arm B, Study Cycle 1~Placebo: Matched placebo PO daily on days 3 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 2~Arm B, Study Cycle 1"
577653|NCT00572572|E1|Reported Event|Aprepitant, Then Placebo|"Arm A, Study Cycle 1~Arm B, Study Cycle 2~Aprepitant: Aprepitant 125mg PO day 3 then 80mg on days 4 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 1~Arm B, Study Cycle 2"
577654|NCT00572533|B3|Baseline|Total|Total of all reporting groups
577655|NCT00572533|B2|Baseline|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577656|NCT00572533|B1|Baseline|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577657|NCT00572533|P2|Participant Flow|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577658|NCT00572533|P1|Participant Flow|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577659|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577660|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577661|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577662|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577663|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577664|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577665|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577666|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577667|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577668|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577669|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577670|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577671|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577672|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577673|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577674|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577675|NCT00572533|E2|Reported Event|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
577676|NCT00572533|E1|Reported Event|Control|ESA Dose Adjustment per standard Anemia Management Protocol
577677|NCT00572468|B3|Baseline|Total|Total of all reporting groups
577678|NCT00572468|B2|Baseline|Placebo|Participants were randomized into the placebo arm of this trial.
577679|NCT00572468|B1|Baseline|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
577680|NCT00572468|P2|Participant Flow|Placebo|Participants were randomized into the placebo arm of this trial.
577681|NCT00572468|P1|Participant Flow|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
577682|NCT00572468|O2|Outcome|Placebo|Participants were randomized into the placebo arm of this trial.
577683|NCT00572468|O1|Outcome|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
577684|NCT00572468|O2|Outcome|Placebo|Participants were randomized into the placebo arm of this trial.
577686|NCT00572468|E2|Reported Event|Placebo|Participants were randomized into the placebo arm of this trial.
577687|NCT00572468|E1|Reported Event|Simvastatin|Participants were randomized into the Simvastatin arm of this trial.
577688|NCT00572260|B1|Baseline|Antimicrobial Prophylaxis Administration With Daptomycin|
577689|NCT00572260|P1|Participant Flow|Antimicrobial Prophylaxis Administration With Daptomycin|
577690|NCT00572260|O1|Outcome|Patients Undergoing Cardiac Surgery|Patients undergoing cardiac valve replacement and coronary artery bypass grafting
577691|NCT00572260|E1|Reported Event|Antimicrobial Prophylaxis Administration With Daptomycin|
577692|NCT00572156|B5|Baseline|Total|Total of all reporting groups
577693|NCT00572156|B4|Baseline|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577694|NCT00572156|B3|Baseline|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577695|NCT00572156|B2|Baseline|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577696|NCT00572156|B1|Baseline|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577697|NCT00572156|P4|Participant Flow|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577698|NCT00572156|P3|Participant Flow|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577699|NCT00572156|P2|Participant Flow|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections
577700|NCT00572156|P1|Participant Flow|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection
577701|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577702|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577703|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577704|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577705|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577706|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577707|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577708|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577709|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577710|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577711|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577712|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577713|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577714|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577715|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577716|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577717|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577718|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577719|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577720|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577721|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577722|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577723|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577724|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577725|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577726|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577727|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577728|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577729|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577730|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577731|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577732|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577733|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577734|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577735|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577736|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577737|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577738|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577739|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577740|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577741|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577742|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577743|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577744|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577745|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577746|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577747|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577748|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577749|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577750|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577751|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577752|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577753|NCT00572156|E4|Reported Event|4. 45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
577754|NCT00572156|E3|Reported Event|3. 45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
577755|NCT00572156|E2|Reported Event|2. 45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
577756|NCT00572156|E1|Reported Event|1. rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
577757|NCT00572117|B3|Baseline|Total|Total of all reporting groups
577758|NCT00572117|B2|Baseline|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
577759|NCT00572117|B1|Baseline|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
577760|NCT00572117|P2|Participant Flow|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
577761|NCT00572117|P1|Participant Flow|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
577762|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in HAM-D score from baseline
577763|NCT00572117|O1|Outcome|Topiramate|Change in HAM-D score from baseline
577764|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in average number of drinks/heavy drinking day
577765|NCT00572117|O1|Outcome|Topiramate|Change in average number of drinks/heavy drinking day
577766|NCT00572117|E2|Reported Event|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
577767|NCT00572117|E1|Reported Event|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
577768|NCT00572039|B3|Baseline|Total|Total of all reporting groups
577769|NCT00572039|B2|Baseline|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
577770|NCT00572039|B1|Baseline|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
577771|NCT00572039|P2|Participant Flow|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
577772|NCT00572039|P1|Participant Flow|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
577773|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
577774|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
577796|NCT00571974|E1|Reported Event|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
577832|NCT00571701|O2|Outcome|Placebo First- HPV 6|Subjects infected with HPV 6 treated with placebo during first treatment period
581600|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
577775|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
577776|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
577777|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
577778|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
577779|NCT00572039|O2|Outcome|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
577780|NCT00572039|O1|Outcome|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
577781|NCT00572039|E2|Reported Event|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
577782|NCT00572039|E1|Reported Event|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
577783|NCT00571987|B1|Baseline|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
577784|NCT00571987|P1|Participant Flow|Subjects Received RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
577785|NCT00571987|O1|Outcome|Recurrences at the Site|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
577786|NCT00571987|O1|Outcome|Margin Status|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
577787|NCT00571987|E1|Reported Event|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
577788|NCT00571974|B3|Baseline|Total|Total of all reporting groups
577789|NCT00571974|B2|Baseline|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
577790|NCT00571974|B1|Baseline|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
577791|NCT00571974|P2|Participant Flow|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
577792|NCT00571974|P1|Participant Flow|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
577793|NCT00571974|O1|Outcome|Phase II|Subjects treated with the MTD.
577794|NCT00571974|O1|Outcome|Phase I|Participants in the Phase I part of the study.
577795|NCT00571974|E2|Reported Event|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
577831|NCT00571701|O3|Outcome|Celecoxib First- HPV 11|Subjects infected with HPV 11 treated with celecoxib during the first treatment period
581601|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
577797|NCT00571961|B1|Baseline|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
577798|NCT00571961|P1|Participant Flow|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r once daily in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
577799|NCT00571961|O1|Outcome|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
577800|NCT00571961|E1|Reported Event|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
577801|NCT00571948|B3|Baseline|Total|Total of all reporting groups
577802|NCT00571948|B2|Baseline|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
577803|NCT00571948|B1|Baseline|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
577804|NCT00571948|P2|Participant Flow|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
577805|NCT00571948|P1|Participant Flow|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
577806|NCT00571948|O2|Outcome|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
577807|NCT00571948|O1|Outcome|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
577808|NCT00571948|E2|Reported Event|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
577809|NCT00571948|E1|Reported Event|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
577810|NCT00571922|B3|Baseline|Total|Total of all reporting groups
577811|NCT00571922|B2|Baseline|Placebo|placebo: matching placebo
577812|NCT00571922|B1|Baseline|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
577813|NCT00571922|P2|Participant Flow|Placebo|placebo: matching placebo
577814|NCT00571922|P1|Participant Flow|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
577815|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
577816|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
577817|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
577818|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
577819|NCT00571922|E2|Reported Event|Placebo|placebo: matching placebo
577820|NCT00571922|E1|Reported Event|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
577821|NCT00571701|B3|Baseline|Total|Total of all reporting groups
577822|NCT00571701|B2|Baseline|Placebo First, Then Celecoxib|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577823|NCT00571701|B1|Baseline|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577824|NCT00571701|P2|Participant Flow|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577825|NCT00571701|P1|Participant Flow|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577826|NCT00571701|O2|Outcome|Celecoxib Responders- Not Maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period whose papilloma growth rate worsened by more than 0.01 at end of second treatment period.
577827|NCT00571701|O1|Outcome|Celecoxib Responders-maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period that maintained response at end of second treatment.
577828|NCT00571701|O2|Outcome|Non-responders|Subjects randomized to celecoxib first with response less than 50% at end of first treatment period relative to mean disease severity prior to treatment.
577829|NCT00571701|O1|Outcome|Responders|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period relative to mean disease severity prior to treatment.
577830|NCT00571701|O4|Outcome|Placebo First- HPV 11|Subjects infected with HPV 11 treated with placebo during the first treatment period
577833|NCT00571701|O1|Outcome|Celecoxib First - HPV 6|Subjects infected with HPV 6 treated with celecoxib during the first treatment period
577834|NCT00571701|O4|Outcome|Placebo First- Adult-onset|Adult-onset subjects treated with placebo during the first treatment
577835|NCT00571701|O3|Outcome|Celecoxib First - Adult Onset|Adult-onset subjects treated with celecoxib during the first treatment period
577836|NCT00571701|O2|Outcome|Placebo First- Juvenile-onsent|Juvenile-onset subjects treated with placebo during first treatment period
577837|NCT00571701|O1|Outcome|Celecoxib First- Juvenile Onset|Juvenile-onset subjects treated with celecoxib during the first treatment period
577838|NCT00571701|O4|Outcome|Placebo First- Females|Females treated with placebo during the first treatment period
577839|NCT00571701|O3|Outcome|Celecoxib First- Females|Females treated with celecoxib during the first treatment period
577840|NCT00571701|O2|Outcome|Placebo First- Males|Males treated with placebo during the first treatment period
577841|NCT00571701|O1|Outcome|Celecoxib First - Males|Males treated with celecoxib during the first treatment period
577842|NCT00571701|O2|Outcome|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577843|NCT00571701|O1|Outcome|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577844|NCT00571701|O2|Outcome|Placebo First, Then Celecoxib|"Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577845|NCT00571701|O1|Outcome|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
577846|NCT00571701|E2|Reported Event|Placebo|Patients who received placebo for 12 months during either time period
577847|NCT00571701|E1|Reported Event|Celecoxib|Patients who received celecoxib for 12 months during either time period
577848|NCT00571688|B3|Baseline|Total|Total of all reporting groups
577849|NCT00571688|B2|Baseline|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
577850|NCT00571688|B1|Baseline|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
577851|NCT00571688|P2|Participant Flow|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
577852|NCT00571688|P1|Participant Flow|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg intramuscularly (IM) every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
577853|NCT00571688|O2|Outcome|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
577854|NCT00571688|O1|Outcome|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
577855|NCT00571688|E2|Reported Event|Treatment As Usual|Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
577889|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577890|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577936|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
577856|NCT00571688|E1|Reported Event|Risperdal Consta|"Risperdal Consta injection in conjunction with existing treatment~Risperdal (risperidone) Consta: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) YMRS score > 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period."
577857|NCT00571662|B1|Baseline|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
577858|NCT00571662|P1|Participant Flow|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
577859|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
577860|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
577861|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
577862|NCT00571662|E1|Reported Event|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
577863|NCT00571649|B3|Baseline|Total|Total of all reporting groups
577864|NCT00571649|B2|Baseline|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days (SAF population)
577865|NCT00571649|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days (SAF population)
577866|NCT00571649|P2|Participant Flow|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days during treatment period
577867|NCT00571649|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days during treatment period
577868|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577869|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577870|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577871|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577872|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577873|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577874|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577875|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577876|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577877|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577878|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577879|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577880|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577881|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577882|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577883|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577884|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577885|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577886|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577887|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577888|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577891|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577892|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577893|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577894|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577895|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577896|NCT00571649|E2|Reported Event|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
577897|NCT00571649|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
577898|NCT00571428|B3|Baseline|Total|Total of all reporting groups
577899|NCT00571428|B2|Baseline|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
577900|NCT00571428|B1|Baseline|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
577901|NCT00571428|P2|Participant Flow|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
577902|NCT00571428|P1|Participant Flow|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
577903|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577904|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577905|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577906|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577907|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577908|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577909|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577910|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577911|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577912|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577913|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577914|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577915|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577916|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577917|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577918|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577919|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577920|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577921|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577922|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577923|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577924|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577925|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577926|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577927|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577928|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577929|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577930|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577931|NCT00571428|E2|Reported Event|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
577932|NCT00571428|E1|Reported Event|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
577933|NCT00571324|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
577934|NCT00571324|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours. The following day, after another overnight fast, Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. During both infusions, blood glucose levels were measured every 20 minutes.
577935|NCT00571324|P1|Participant Flow|Exendin-(9-39) First, the Vehicle|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. The following day, after another overnight fast, normal saline (control) vehicle infusion was administered intravenously (IV) over 6 hours. During both infusions, blood glucose levels were measured every 20 minutes.
577937|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
577938|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
577939|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
577940|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
577941|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
577942|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
577943|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
577944|NCT00571324|E2|Reported Event|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
577945|NCT00571324|E1|Reported Event|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
577946|NCT00571194|B1|Baseline|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
577947|NCT00571194|P1|Participant Flow|Pravastatin|Study drug given and have levels done to measure pharmacokinetics.
577948|NCT00571194|O1|Outcome|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
577949|NCT00571194|E1|Reported Event|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
577950|NCT00571103|B1|Baseline|Open Label|All subjects received the drug.
577951|NCT00571103|P1|Participant Flow|Open Label|All subjects received the drug.
577952|NCT00571103|O1|Outcome|Open Label|All subjects received the drug.
577953|NCT00571103|O1|Outcome|Open Label|All subjects received the drug.
577954|NCT00571103|E1|Reported Event|Open Label|All subjects received the drug.
577955|NCT00571064|B1|Baseline|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 milligram (mg) per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577956|NCT00571064|P1|Participant Flow|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 milligrams (mg) per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577957|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577958|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577959|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577960|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577961|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577980|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577962|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577963|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577964|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577965|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577966|NCT00571064|O1|Outcome|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 milligram (mg) per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577967|NCT00571064|E1|Reported Event|Donepezil Hydrochloride (HCl)|Donepezil HCl 5 mg per day (one 5 mg tablet) was administered for the first 6 weeks (42 days), and then the dose was increased to 10 mg/day (two 5 mg tablets). If 10 mg of donepezil was not tolerated, the dosage was reduced temporarily to 5 mg. The participant was re-challenged with 10 mg of study drug within 5 to 7 days. If the participant still could not tolerate the higher dose after re-challenge, they continued in the study on 5 mg per day of study drug.
577968|NCT00571038|B3|Baseline|Total|Total of all reporting groups
577969|NCT00571038|B2|Baseline|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577970|NCT00571038|B1|Baseline|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577971|NCT00571038|P2|Participant Flow|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577972|NCT00571038|P1|Participant Flow|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577973|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577974|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577975|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577976|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577977|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577978|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577979|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577981|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577982|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577983|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577984|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577985|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577986|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577987|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577988|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577989|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577990|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577991|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577992|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577993|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577994|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577995|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577996|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577997|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
577998|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
577999|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578000|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578001|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578045|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578603|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578002|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578003|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578004|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578005|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578006|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578007|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578008|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578009|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578010|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578011|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578012|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578013|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578014|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578015|NCT00571038|E2|Reported Event|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
578016|NCT00571038|E1|Reported Event|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
578017|NCT00570960|B3|Baseline|Total|Total of all reporting groups
578018|NCT00570960|B2|Baseline|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
578019|NCT00570960|B1|Baseline|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
578020|NCT00570960|P2|Participant Flow|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
578021|NCT00570960|P1|Participant Flow|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
578022|NCT00570960|O2|Outcome|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
578023|NCT00570960|O1|Outcome|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
578024|NCT00570960|E2|Reported Event|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
578025|NCT00570960|E1|Reported Event|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
578776|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first
578026|NCT00570921|B1|Baseline|Fulvestrant & Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.~Everolimus: Everolimus tablets, two-5 mg tablets a day~Fulvestrant: intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter"
578027|NCT00570921|P1|Participant Flow|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
578028|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
578029|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
578030|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
578031|NCT00570921|E1|Reported Event|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
578032|NCT00570908|B1|Baseline|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
578033|NCT00570908|P1|Participant Flow|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
578034|NCT00570908|O1|Outcome|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
578035|NCT00570908|E1|Reported Event|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
578036|NCT00570778|B1|Baseline|Overall Population|Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.
578037|NCT00570778|P4|Participant Flow|D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg|"Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days."
578038|NCT00570778|P3|Participant Flow|C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo|"Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days."
578039|NCT00570778|P2|Participant Flow|B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg|"Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days."
578040|NCT00570778|P1|Participant Flow|A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg|"Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.~Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days."
578041|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578042|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578043|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578044|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578046|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578047|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578048|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578049|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578050|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578051|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578052|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578053|NCT00570778|E4|Reported Event|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578054|NCT00570778|E3|Reported Event|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
578055|NCT00570778|E2|Reported Event|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578056|NCT00570778|E1|Reported Event|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
578057|NCT00570765|B4|Baseline|Total|Total of all reporting groups
578058|NCT00570765|B3|Baseline|Placebo|Placebo by mouth, daily
578059|NCT00570765|B2|Baseline|50 mg|INT-747 50 mg by mouth, daily
578060|NCT00570765|B1|Baseline|10 mg|INT-747 10 mg by mouth, daily
578061|NCT00570765|P3|Participant Flow|Placebo|Placebo by mouth, daily
578062|NCT00570765|P2|Participant Flow|50 mg|INT-747 50 mg by mouth, daily
578063|NCT00570765|P1|Participant Flow|10 mg|INT-747 10 mg by mouth, daily
578064|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
578065|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
578066|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
578067|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
578068|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
578069|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
578070|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
578071|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
578072|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
578073|NCT00570765|E3|Reported Event|Placebo|Placebo by mouth, daily
578074|NCT00570765|E2|Reported Event|50 mg|INT-747 50 mg by mouth, daily
578075|NCT00570765|E1|Reported Event|10 mg|INT-747 10 mg by mouth, daily
578076|NCT00570739|B5|Baseline|Total|Total of all reporting groups
578077|NCT00570739|B4|Baseline|Pre-diabetic Group: Colesevelam|This group received 6 colesevelam tablets, 625mg, once per day for 16 weeks.
578078|NCT00570739|B3|Baseline|Pre-diabetic Group: Placebo|This group received 6 colesevelam matching placebo tablets once per day for 16 weeks
578079|NCT00570739|B2|Baseline|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
578080|NCT00570739|B1|Baseline|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
578081|NCT00570739|P4|Participant Flow|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
578082|NCT00570739|P3|Participant Flow|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
578083|NCT00570739|P2|Participant Flow|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
578084|NCT00570739|P1|Participant Flow|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
578085|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578086|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578087|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578088|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578089|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578090|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578091|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578092|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578093|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578094|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578095|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578096|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578097|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578098|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578099|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578100|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578101|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578102|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578103|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578104|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578105|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578106|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578107|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578108|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578109|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578110|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578111|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578112|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578113|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578114|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578115|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578116|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578117|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578118|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578119|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578120|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578121|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578122|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578123|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578124|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578125|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578126|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578127|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578128|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578129|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578130|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578131|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578132|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578133|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578134|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578135|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578136|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578137|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578138|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578139|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578140|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578141|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578142|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578143|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578144|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578145|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578146|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578147|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578148|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578149|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578150|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578151|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578152|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578153|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg once daily. The total treatment duration was 16 weeks.
578154|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The total treatment duration was 16 weeks.
578155|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578156|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578157|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578158|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578159|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578160|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578161|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578162|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578163|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578164|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578165|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
578166|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
578167|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578168|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578169|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578170|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578171|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578172|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578173|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578174|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578175|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578176|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578177|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578178|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578179|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578180|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578181|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578182|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578183|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578184|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578185|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578186|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578187|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578188|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578189|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578190|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578191|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578192|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578193|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578194|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578195|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578196|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578197|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578271|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578198|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578199|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578200|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578201|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578202|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578203|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578204|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578205|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578206|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578207|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578208|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578209|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578210|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578211|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578212|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578213|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578214|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578215|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578216|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578217|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578218|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578219|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
578220|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
578221|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578222|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578223|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578224|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578225|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578226|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578227|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
578228|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
578229|NCT00570739|E4|Reported Event|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
578230|NCT00570739|E3|Reported Event|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
578231|NCT00570739|E2|Reported Event|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
578232|NCT00570739|E1|Reported Event|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
578233|NCT00570713|B3|Baseline|Total|Total of all reporting groups
578234|NCT00570713|B2|Baseline|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578235|NCT00570713|B1|Baseline|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578236|NCT00570713|P2|Participant Flow|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578237|NCT00570713|P1|Participant Flow|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578238|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578239|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578240|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578241|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578242|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578272|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578243|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578244|NCT00570713|E2|Reported Event|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578245|NCT00570713|E1|Reported Event|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
578246|NCT00570700|B1|Baseline|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
578247|NCT00570700|P1|Participant Flow|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
578248|NCT00570700|O1|Outcome|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
578249|NCT00570700|O1|Outcome|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
578250|NCT00570700|O1|Outcome|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
578251|NCT00570700|E1|Reported Event|Dasatinib|"Patients receive oral dasatinib once daily in the absence of disease progression or unacceptable toxicity.~Dasatinib: 150mg (3 pills) orally daily for as long as the drug benefits"
578252|NCT00570687|B3|Baseline|Total|Total of all reporting groups
578253|NCT00570687|B2|Baseline|Original Protocol|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578254|NCT00570687|B1|Baseline|Amendment 1|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578255|NCT00570687|P10|Participant Flow|Original Protocol: Insulin Lispro to Exubera to TI|12 U of subcutaneously administered insulin lispro, followed by 4 mg of Exubera administered via inhalation, and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
578256|NCT00570687|P9|Participant Flow|Original Protocol: Insulin Lispro to TI to Exubera|12 U of subcutaneously administered insulin lispro, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, and then 4 mg of Exubera administered via inhalation
578257|NCT00570687|P8|Participant Flow|Original Protocol: Exubera to TI to Insulin Lispro|4 mg of Exubera administered via inhalation, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler,. and then 12 U of subcutaneously administered insulin lispro
578258|NCT00570687|P7|Participant Flow|Original Protocol: Exubera to Insulin Lispro to TI|4 mg of Exubera administered via inhalation, followed by 12 U of subcutaneously administered insulin lispro,and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
578259|NCT00570687|P6|Participant Flow|Original Protocol: TI to Exubera to Insulin Lispro|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 4 mg of Exubera administered via inhalation, and then 12 U of subcutaneously administered insulin lispro
578260|NCT00570687|P5|Participant Flow|Original Protocol: TI to Insulin Lispro to Exubera|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 12 U of subcutaneously administered insulin lispro, and then 4 mg of Exubera administered via inhalation
578261|NCT00570687|P4|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 90 U TI|10 U subcutaneously administered insulin lispro, followed by 90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
578262|NCT00570687|P3|Participant Flow|Amendment 1: TI 90 U Then 10 U Insulin Lispro|90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
578263|NCT00570687|P2|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 60 U TI|10 U subcutaneously administered insulin lispro, followed by 60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
578264|NCT00570687|P1|Participant Flow|Amendment 1: TI 60 U Then Insulin Lispro 10 U|60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
578265|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578266|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578267|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578268|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578269|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578270|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578273|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578274|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578275|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578276|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578277|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578278|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578279|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578280|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578281|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578282|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578283|NCT00570687|E6|Reported Event|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578284|NCT00570687|E5|Reported Event|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578285|NCT00570687|E4|Reported Event|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
578286|NCT00570687|E3|Reported Event|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578287|NCT00570687|E2|Reported Event|Amendment 1 - TI Inhalation Powder 60 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578288|NCT00570687|E1|Reported Event|Amendment 1 -TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
578289|NCT00570674|B1|Baseline|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578290|NCT00570674|P7|Participant Flow|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578291|NCT00570674|P6|Participant Flow|Phase I Dose Level 4 Expansion Cohort: AC-RT|"Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.~If no DLTs are observed at dose level 4 then ten additional participants (expansion cohort) will be enrolled at that dose level."
578292|NCT00570674|P5|Participant Flow|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578293|NCT00570674|P4|Participant Flow|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578294|NCT00570674|P3|Participant Flow|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578295|NCT00570674|P2|Participant Flow|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578296|NCT00570674|P1|Participant Flow|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578327|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578328|NCT00570505|E1|Reported Event|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
578297|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578298|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578299|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578300|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578301|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578302|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578303|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578304|NCT00570674|O1|Outcome|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578305|NCT00570674|O5|Outcome|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578306|NCT00570674|O4|Outcome|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578307|NCT00570674|O3|Outcome|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578308|NCT00570674|O2|Outcome|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578309|NCT00570674|O1|Outcome|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578310|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578311|NCT00570674|E1|Reported Event|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
578312|NCT00570531|B1|Baseline|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
578313|NCT00570531|P1|Participant Flow|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
578314|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
578315|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
578316|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
578317|NCT00570531|E1|Reported Event|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
578318|NCT00570505|B1|Baseline|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
578319|NCT00570505|P1|Participant Flow|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578320|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578321|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578322|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578323|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578324|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578325|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578326|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
578330|NCT00570492|B2|Baseline|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578331|NCT00570492|B1|Baseline|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578332|NCT00570492|P3|Participant Flow|FFNS 110 mcg: Double-blind Treatment Period|Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
578333|NCT00570492|P2|Participant Flow|Placebo: Double-blind Treatment Period|Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
578334|NCT00570492|P1|Participant Flow|Placebo: Baseline Period|Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
578335|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578336|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578337|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578338|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578339|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578340|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578341|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578342|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578343|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578344|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578345|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578346|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578347|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578348|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578349|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578350|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578351|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578560|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578352|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578353|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578354|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578355|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578356|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578357|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578358|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578359|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578360|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578361|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578362|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578363|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578364|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578365|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578366|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578367|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578368|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578369|NCT00570492|E2|Reported Event|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
578370|NCT00570492|E1|Reported Event|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
578371|NCT00570401|B1|Baseline|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
578372|NCT00570401|P1|Participant Flow|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
578373|NCT00570401|O1|Outcome|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
578374|NCT00570401|E1|Reported Event|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
578375|NCT00570362|B3|Baseline|Total|Total of all reporting groups
578960|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
578376|NCT00570362|B2|Baseline|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
578377|NCT00570362|B1|Baseline|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
578378|NCT00570362|P2|Participant Flow|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
578379|NCT00570362|P1|Participant Flow|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
578380|NCT00570362|O2|Outcome|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
578381|NCT00570362|O1|Outcome|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
578382|NCT00570362|E2|Reported Event|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
578383|NCT00570362|E1|Reported Event|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
578384|NCT00570349|B4|Baseline|Total|Total of all reporting groups
578385|NCT00570349|B3|Baseline|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
578386|NCT00570349|B2|Baseline|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
578387|NCT00570349|B1|Baseline|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
578388|NCT00570349|P3|Participant Flow|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
578389|NCT00570349|P2|Participant Flow|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
578390|NCT00570349|P1|Participant Flow|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
578391|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
578392|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
578393|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
578394|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
578395|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
578396|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
578397|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
578398|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
578399|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
578400|NCT00570349|E3|Reported Event|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
578401|NCT00570349|E2|Reported Event|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
578402|NCT00570349|E1|Reported Event|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
578403|NCT00570310|B3|Baseline|Total|Total of all reporting groups
578404|NCT00570310|B2|Baseline|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
578405|NCT00570310|B1|Baseline|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
578406|NCT00570310|P2|Participant Flow|Placebo|Patients were treated with placebo starting at randomization.
578407|NCT00570310|P1|Participant Flow|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
578961|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
578408|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
578409|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
578410|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
578411|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
578412|NCT00570310|E2|Reported Event|Placebo|Patients were treated with placebo starting at randomization.
578413|NCT00570310|E1|Reported Event|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
578414|NCT00570232|B1|Baseline|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
578415|NCT00570232|P1|Participant Flow|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
578416|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
578417|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
578418|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
578419|NCT00570232|E1|Reported Event|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
578420|NCT00570141|B1|Baseline|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
578421|NCT00570141|P1|Participant Flow|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
578422|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
578423|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
578424|NCT00570141|E1|Reported Event|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
578425|NCT00570089|B1|Baseline|All Study Participants|Participants who were randomized to receive either Study drug Ranexa or Placebo.
578426|NCT00570089|P2|Participant Flow|Placebo Then Study Drug Ranexa|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
578427|NCT00570089|P1|Participant Flow|Study Drug Ranexa Then Placebo|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
578428|NCT00570089|O2|Outcome|Placebo|Placebo arm
578429|NCT00570089|O1|Outcome|Study Drug|Study drug Ranexa arm
578430|NCT00570089|O2|Outcome|Placebo - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
578431|NCT00570089|O1|Outcome|Study Drug Ranexa - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
578432|NCT00570089|E2|Reported Event|Placebo|Placebo arm
578433|NCT00570089|E1|Reported Event|Study Drug|Study drug Ranexa arm
578434|NCT00570063|B3|Baseline|Total|Total of all reporting groups
578435|NCT00570063|B2|Baseline|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578436|NCT00570063|B1|Baseline|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578437|NCT00570063|P2|Participant Flow|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578438|NCT00570063|P1|Participant Flow|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578439|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578440|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578441|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578442|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578443|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578561|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578444|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578445|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578446|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578447|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578448|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578449|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578450|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578451|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578452|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578453|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578454|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578455|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578456|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578457|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578458|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578459|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578460|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578461|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578462|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578463|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578464|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578465|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578466|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578467|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578468|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578469|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578470|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578471|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578472|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578473|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578474|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578562|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578475|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578476|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578477|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578478|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578479|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578480|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578481|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578482|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578483|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578484|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578485|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578486|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578487|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578488|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578489|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578490|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578491|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578492|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578493|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578494|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578495|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578496|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578497|NCT00570063|O2|Outcome|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578498|NCT00570063|O1|Outcome|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578499|NCT00570063|E2|Reported Event|Placebo|Participants received single dose of placebo tablet matched to PF-02545920, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578500|NCT00570063|E1|Reported Event|PF-02545920 15 Milligram (mg)|Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.
578501|NCT00570037|B3|Baseline|Total|Total of all reporting groups
578502|NCT00570037|B2|Baseline|Hospital With No Immunization Program|
578503|NCT00570037|B1|Baseline|Hospital With Immunization Program|
578504|NCT00570037|P2|Participant Flow|Hospital With No Immunization Program|
578505|NCT00570037|P1|Participant Flow|Hospital With Immunization Program|
578506|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
578507|NCT00570037|O1|Outcome|Hospital With Immunization Program|
578508|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
578509|NCT00570037|O1|Outcome|Hospital With Immunization Program|
578510|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
578511|NCT00570037|O1|Outcome|Hospital With Immunization Program|
578512|NCT00570037|E2|Reported Event|Hospital With No Immunization Program|
578513|NCT00570037|E1|Reported Event|Hospital With Immunization Program|
578563|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578514|NCT00569946|B1|Baseline|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578515|NCT00569946|P1|Participant Flow|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578516|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578517|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578518|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578519|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578520|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578521|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578522|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578523|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578524|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578525|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578526|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578527|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578564|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578528|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578529|NCT00569946|E1|Reported Event|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
578530|NCT00569868|B1|Baseline|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
578531|NCT00569868|P1|Participant Flow|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
578532|NCT00569868|O1|Outcome|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
578533|NCT00569868|E1|Reported Event|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
578534|NCT00569855|B1|Baseline|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
578535|NCT00569855|P1|Participant Flow|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
578536|NCT00569855|O1|Outcome|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
578537|NCT00569855|E1|Reported Event|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
578538|NCT00569803|B9|Baseline|Total|Total of all reporting groups
578539|NCT00569803|B8|Baseline|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578540|NCT00569803|B7|Baseline|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578541|NCT00569803|B6|Baseline|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578542|NCT00569803|B5|Baseline|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578543|NCT00569803|B4|Baseline|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578544|NCT00569803|B3|Baseline|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578545|NCT00569803|B2|Baseline|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578546|NCT00569803|B1|Baseline|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578547|NCT00569803|P8|Participant Flow|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578548|NCT00569803|P7|Participant Flow|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578549|NCT00569803|P6|Participant Flow|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578550|NCT00569803|P5|Participant Flow|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578551|NCT00569803|P4|Participant Flow|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578552|NCT00569803|P3|Participant Flow|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578553|NCT00569803|P2|Participant Flow|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578554|NCT00569803|P1|Participant Flow|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578555|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578556|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578557|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578558|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578559|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578565|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578566|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578567|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578568|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578569|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578570|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578571|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578572|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578573|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578574|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578575|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578576|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578577|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578578|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578579|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578580|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578581|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578582|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578583|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578584|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578585|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578586|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578587|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578588|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578589|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578590|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578591|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578592|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578593|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578594|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578595|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578596|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578597|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578598|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578599|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578600|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578601|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578602|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578604|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578605|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578606|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578607|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578608|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578609|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578610|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578611|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578612|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578613|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578614|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578615|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578616|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578617|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578618|NCT00569803|O2|Outcome|2 Injection Sites|Participants receiving treatments of 150mg, 200mg and 250mg Subcutaneous Belatacept were injected at 2 sites; one injection equal to half the total dose was delivered to the anterior thigh on each side.
578619|NCT00569803|O1|Outcome|1 Injection Site|Participants receiving treatments of 50mg, 100mg and 125mg Subcutaneous Belatacept were injected at 1 site at the anterior thigh.
578620|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578621|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578622|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578623|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578624|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578625|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578626|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578627|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578628|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578629|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578630|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578631|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578632|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578633|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578634|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578635|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578636|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578637|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578638|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578639|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578640|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578641|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578642|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578643|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578644|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578645|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578646|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578647|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578648|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578649|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578650|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578651|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578652|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578653|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578654|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578655|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578656|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578657|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578658|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578659|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578660|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578661|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578662|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
578663|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578664|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578665|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578666|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578667|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578668|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578669|NCT00569803|E9|Reported Event|All Belatacept|All participants treated with IV or SC Belatacept of any dose
578670|NCT00569803|E8|Reported Event|PLACEBO|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
578671|NCT00569803|E7|Reported Event|Belatacept 125mg IV|125 mg Belatacept intravenous (IV) injection
578672|NCT00569803|E6|Reported Event|Belatacept 250mg SC|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578673|NCT00569803|E5|Reported Event|Belatacept 200mg SC|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578674|NCT00569803|E4|Reported Event|Belatacept 150mg SC|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
578675|NCT00569803|E3|Reported Event|Belatacept 125mg SC|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
578676|NCT00569803|E2|Reported Event|Belatacept 100mg SC|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
578677|NCT00569803|E1|Reported Event|Belatacept 50mg SC|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
578678|NCT00569777|B3|Baseline|Total|Total of all reporting groups
578679|NCT00569777|B2|Baseline|Placebo|etafilcon A contact lens without ketotifen
578680|NCT00569777|B1|Baseline|K-lens|etafilcon A contact lens with ketotifen.
578681|NCT00569777|P2|Participant Flow|Placebo|etafilcon A contact lens without ketotifen
578682|NCT00569777|P1|Participant Flow|K-lens|etafilcon A contact lens with ketotifen.
578683|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578684|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578685|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578686|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578687|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578688|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578689|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578690|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578691|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578692|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578693|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578694|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578695|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578696|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578697|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578698|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578699|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578700|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578701|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578702|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578703|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578704|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578705|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578706|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578707|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578708|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578709|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578710|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578711|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578712|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578713|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578714|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578715|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578716|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578717|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578718|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578719|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
578720|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
578721|NCT00569777|E2|Reported Event|Placebo|etafilcon A contact lens without ketotifen
578722|NCT00569777|E1|Reported Event|K-lens|etafilcon A contact lens with ketotifen.
578723|NCT00569673|B1|Baseline|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
578724|NCT00569673|P1|Participant Flow|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
578725|NCT00569673|O1|Outcome|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
578726|NCT00569673|E1|Reported Event|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
578727|NCT00569660|B1|Baseline|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
578728|NCT00569660|P1|Participant Flow|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
578729|NCT00569660|O1|Outcome|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
578730|NCT00569660|E1|Reported Event|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
578731|NCT00569582|B1|Baseline|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
578732|NCT00569582|P1|Participant Flow|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
578733|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
578734|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
578735|NCT00569582|E1|Reported Event|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
578736|NCT00569530|B3|Baseline|Total|Total of all reporting groups
578737|NCT00569530|B2|Baseline|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
578738|NCT00569530|B1|Baseline|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
578739|NCT00569530|P2|Participant Flow|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
578740|NCT00569530|P1|Participant Flow|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
578741|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
578742|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
578743|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
578744|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
578745|NCT00569530|E2|Reported Event|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
578746|NCT00569530|E1|Reported Event|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
578747|NCT00569374|B1|Baseline|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578748|NCT00569374|P1|Participant Flow|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578749|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578750|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578751|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578752|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578753|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578754|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578755|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578756|NCT00569374|E1|Reported Event|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
578757|NCT00569309|B1|Baseline|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578758|NCT00569309|P1|Participant Flow|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578759|NCT00569309|O1|Outcome|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578777|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578778|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578760|NCT00569309|O1|Outcome|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578761|NCT00569309|O1|Outcome|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578762|NCT00569309|O1|Outcome|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578763|NCT00569309|O1|Outcome|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578764|NCT00569309|O1|Outcome|Prevnar|"The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.~Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)~laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.~quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G."
578765|NCT00569309|E1|Reported Event|Prevnar|The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
578766|NCT00569270|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Tiotropium first.
578767|NCT00569270|P2|Participant Flow|Placebo First, Then Tiotropium Bromide 18 µg|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
578768|NCT00569270|P1|Participant Flow|Tiotropium 18 µg Capsule First, Then Placebo|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
578769|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FRC/TLC|Extent of lung CT scored emphysema (percent of lung) and lung function of FRC/TLC (functional residual capacity(L)/total lung capacity (L) after tiotropium
578770|NCT00569270|O2|Outcome|TLC (L) 2h Post Tiotropium|Total Lung Capacity (L)following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h tiotropium
578771|NCT00569270|O1|Outcome|2h Post Placebo TLC(L)|total lung capacity (L) following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
578772|NCT00569270|O2|Outcome|After DH (Dynamic Hyperinflation|IC (inspiratory capacity) before and after metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
578773|NCT00569270|O1|Outcome|Before DH (Dynamic Hyperinflation)|IC (inspiratory capacity) before and after metronome paced hyperventilation and induced dynamic hyperinflation at baseline;
578774|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578775|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578779|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578780|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578781|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578782|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578783|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578784|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578785|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578786|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578787|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578788|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578789|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578790|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578791|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578792|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and IC|Extent of lung CT scored emphysema (percent of lung) and lung function of IC (inspiratory capacity, L) after tiotropium.
578793|NCT00569270|O2|Outcome|Tiotropium 18 µg Capsule, Bronchodilator|Includes groups randomized to receive placebo first and Tiotropium first.
578794|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578795|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578796|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578797|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FEV1|Extent of lung CT scored emphysema and and lung function of FEV1(l) after tiotropium
578798|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
578799|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
578800|NCT00569270|E2|Reported Event|Placebo|Adverse events after placebo. (30 enrolled subjects, one drop-out)
578801|NCT00569270|E1|Reported Event|Tiotropium Bromide 18 µg, Capsule,|tiotropium 18 µg capsule for 1 month. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium. (30 enrolled subjects, one drop-out)
578802|NCT00569231|B1|Baseline|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
578803|NCT00569231|P1|Participant Flow|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
578804|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
578805|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
578806|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
578807|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
578808|NCT00569231|E1|Reported Event|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
578809|NCT00569192|B4|Baseline|Total|Total of all reporting groups
578810|NCT00569192|B3|Baseline|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578811|NCT00569192|B2|Baseline|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578812|NCT00569192|B1|Baseline|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578813|NCT00569192|P3|Participant Flow|0.25 mg MAP0010|0.125mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578814|NCT00569192|P2|Participant Flow|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578815|NCT00569192|P1|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578816|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578817|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578818|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578819|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578820|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578821|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578822|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578823|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578824|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578825|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578826|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578827|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578828|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578829|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578830|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578831|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578832|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578833|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578834|NCT00569192|E3|Reported Event|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578835|NCT00569192|E2|Reported Event|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
578836|NCT00569192|E1|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
578837|NCT00569166|B4|Baseline|Total|Total of all reporting groups
578838|NCT00569166|B3|Baseline|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578839|NCT00569166|B2|Baseline|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578840|NCT00569166|B1|Baseline|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578841|NCT00569166|P3|Participant Flow|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578842|NCT00569166|P2|Participant Flow|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578843|NCT00569166|P1|Participant Flow|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578844|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578845|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578846|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578847|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578848|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578849|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578850|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578851|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578852|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578853|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578854|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578855|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578856|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578857|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578858|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578859|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578860|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578948|NCT00568776|P3|Participant Flow|ELND005 1000 mg BID|oral administration for 78 weeks
578861|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578862|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578863|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578864|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578865|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578866|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578867|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578868|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578869|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578870|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578871|NCT00569166|E3|Reported Event|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578872|NCT00569166|E2|Reported Event|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578873|NCT00569166|E1|Reported Event|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
578874|NCT00569127|B3|Baseline|Total|Total of all reporting groups
578875|NCT00569127|B2|Baseline|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578876|NCT00569127|B1|Baseline|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578877|NCT00569127|P2|Participant Flow|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578878|NCT00569127|P1|Participant Flow|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578879|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578880|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578881|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578882|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578883|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578884|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578885|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578886|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578887|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578949|NCT00568776|P2|Participant Flow|ELND005 250 mg BID|oral administration for 78 weeks
578950|NCT00568776|P1|Participant Flow|Placebo BID|oral administration for 78 weeks
578888|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578889|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578890|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578891|NCT00569127|E2|Reported Event|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578892|NCT00569127|E1|Reported Event|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
578893|NCT00569010|B5|Baseline|Total|Total of all reporting groups
578894|NCT00569010|B4|Baseline|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578895|NCT00569010|B3|Baseline|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
578896|NCT00569010|B2|Baseline|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578897|NCT00569010|B1|Baseline|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
578898|NCT00569010|P4|Participant Flow|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578899|NCT00569010|P3|Participant Flow|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
578900|NCT00569010|P2|Participant Flow|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578901|NCT00569010|P1|Participant Flow|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
578902|NCT00569010|O4|Outcome|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578903|NCT00569010|O3|Outcome|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
578904|NCT00569010|O2|Outcome|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578905|NCT00569010|O1|Outcome|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
578906|NCT00569010|E4|Reported Event|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578907|NCT00569010|E3|Reported Event|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
578908|NCT00569010|E2|Reported Event|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
578909|NCT00569010|E1|Reported Event|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
578910|NCT00568958|B3|Baseline|Total|Total of all reporting groups
578911|NCT00568958|B2|Baseline|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578912|NCT00568958|B1|Baseline|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578913|NCT00568958|P2|Participant Flow|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578951|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
578952|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
578953|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
578954|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
578962|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
578914|NCT00568958|P1|Participant Flow|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578915|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578916|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578917|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578918|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578919|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578920|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578921|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578922|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578923|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578924|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578925|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578955|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
578956|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
578957|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
578958|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
578926|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578927|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578928|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578929|NCT00568958|E2|Reported Event|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
578930|NCT00568958|E1|Reported Event|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
578931|NCT00568854|B3|Baseline|Total|Total of all reporting groups
578932|NCT00568854|B2|Baseline|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578933|NCT00568854|B1|Baseline|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578934|NCT00568854|P2|Participant Flow|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578935|NCT00568854|P1|Participant Flow|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578936|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578937|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578938|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578939|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578940|NCT00568854|E2|Reported Event|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578941|NCT00568854|E1|Reported Event|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
578942|NCT00568776|B5|Baseline|Total|Total of all reporting groups
578943|NCT00568776|B4|Baseline|ELND005 2000 mg BID|oral administration for 78 weeks
578944|NCT00568776|B3|Baseline|ELND005 1000 mg BID|oral administration for 78 weeks
578945|NCT00568776|B2|Baseline|ELND005 250 mg BID|oral administration for 78 weeks
578946|NCT00568776|B1|Baseline|Placebo BID|oral administration for 78 weeks
578947|NCT00568776|P4|Participant Flow|ELND005 2000 mg BID|oral administration for 78 weeks
578963|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
578964|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
578965|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
578966|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
578967|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
578968|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
578969|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
578970|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
578971|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
578972|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
578973|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
578974|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
578975|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
578976|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
578977|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
578978|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
578979|NCT00568776|E4|Reported Event|ELND005 2000 mg BID|oral administration for 78 weeks
578980|NCT00568776|E3|Reported Event|ELND005 1000 mg BID|oral administration for 78 weeks
578981|NCT00568776|E2|Reported Event|ELND005 250 mg BID|oral administration for 78 weeks
578982|NCT00568776|E1|Reported Event|Placebo BID|oral administration for 78 weeks
578983|NCT00568685|B4|Baseline|Total|Total of all reporting groups
578984|NCT00568685|B3|Baseline|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
578985|NCT00568685|B2|Baseline|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578986|NCT00568685|B1|Baseline|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578987|NCT00568685|P3|Participant Flow|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
578988|NCT00568685|P2|Participant Flow|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578989|NCT00568685|P1|Participant Flow|Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578990|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
578991|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578992|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578993|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
578994|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578995|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578996|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
578997|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578998|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
578999|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
579000|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579001|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579002|NCT00568685|O3|Outcome|>0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
579003|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
579004|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
579005|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
579006|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579007|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579008|NCT00568685|O3|Outcome|> 0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
579009|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
579010|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
579011|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
579012|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579013|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579014|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
579015|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579016|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
579017|NCT00568685|E3|Reported Event|Atomoxetine >0.85 mg/kg/Day|Patients who received the actual dose range listed.
579018|NCT00568685|E2|Reported Event|Atomoxetine 0.36-0.85 mg/kg/Day|Patients who received the actual dose range listed.
579019|NCT00568685|E1|Reported Event|Atomoxetine 0.00-0.35 mg/kg/Day|Patients who received the actual dose range listed.
579020|NCT00568555|B3|Baseline|Total|Total of all reporting groups
579021|NCT00568555|B2|Baseline|Placebo - Sugar Pill|
579022|NCT00568555|B1|Baseline|Low Dose Naltrexone|
579023|NCT00568555|P2|Participant Flow|Placebo - Sugar Pill First|Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.
579024|NCT00568555|P1|Participant Flow|Low Dose Naltrexone First|Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
579025|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
579026|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
579027|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
579028|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
579029|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
579030|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
579031|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
579032|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
579033|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
579034|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
579035|NCT00568555|E2|Reported Event|Placebo - Sugar Pill|All participants during the placebo condition
579036|NCT00568555|E1|Reported Event|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
579037|NCT00568451|B5|Baseline|Total|Total of all reporting groups
579038|NCT00568451|B4|Baseline|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
579039|NCT00568451|B3|Baseline|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
579040|NCT00568451|B2|Baseline|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
579041|NCT00568451|B1|Baseline|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
579042|NCT00568451|P4|Participant Flow|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
579043|NCT00568451|P3|Participant Flow|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
579044|NCT00568451|P2|Participant Flow|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
579045|NCT00568451|P1|Participant Flow|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
579046|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
579047|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
579048|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
579049|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
579050|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
579051|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
579052|NCT00568451|O4|Outcome|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
579053|NCT00568451|O3|Outcome|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
579054|NCT00568451|O2|Outcome|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
579055|NCT00568451|O1|Outcome|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
579056|NCT00568451|E4|Reported Event|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
579057|NCT00568451|E3|Reported Event|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
579058|NCT00568451|E2|Reported Event|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
579059|NCT00568451|E1|Reported Event|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
579060|NCT00568399|B1|Baseline|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
579061|NCT00568399|P1|Participant Flow|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
579062|NCT00568399|O1|Outcome|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months
579063|NCT00568399|E1|Reported Event|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
579064|NCT00568386|B3|Baseline|Total|Total of all reporting groups
579065|NCT00568386|B2|Baseline|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
579066|NCT00568386|B1|Baseline|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
579067|NCT00568386|P2|Participant Flow|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
579068|NCT00568386|P1|Participant Flow|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
579069|NCT00568386|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant eye drops
579070|NCT00568386|O1|Outcome|Systane Lubricant Eye Drops|Systane lubricant eye drops
579071|NCT00568386|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant eye drops
579072|NCT00568386|E1|Reported Event|Systane Lubricant Eye Drops|Systane lubricant eye drops
579073|NCT00568334|B3|Baseline|Total|Total of all reporting groups
579074|NCT00568334|B2|Baseline|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579075|NCT00568334|B1|Baseline|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579076|NCT00568334|P2|Participant Flow|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579077|NCT00568334|P1|Participant Flow|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579078|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579079|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579080|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579081|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579082|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579083|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579084|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579085|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579086|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579223|NCT00567879|P6|Participant Flow|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579283|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579087|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579088|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579089|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579090|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579091|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579092|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579093|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579094|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579095|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579096|NCT00568334|O2|Outcome|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579097|NCT00568334|O1|Outcome|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579098|NCT00568334|E2|Reported Event|Varilrix Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579099|NCT00568334|E1|Reported Event|Varilrix HSA-Free Group|Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
579100|NCT00568178|B3|Baseline|Total|Total of all reporting groups
579101|NCT00568178|B2|Baseline|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
579102|NCT00568178|B1|Baseline|Losartan|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
579103|NCT00568178|P6|Participant Flow|Enalapril Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator’s discretion.~Enalapril 2.5-, 5-, 10-, and 20-mg tablets were available for participants able to swallow tablets. For participants unable to swallow tablets, or who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared."
579104|NCT00568178|P5|Participant Flow|Losartan Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator’s discretion.~Losartan 25-mg and 50-mg tablets were available for patients able to swallow tablets. For patients unable to swallow tablets, or who weighed <25 kg, losartan suspension (2.5 mg/ml) was prepared."
579151|NCT00568022|P1|Participant Flow|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579105|NCT00568178|P4|Participant Flow|Amlodipine Double Blind Hypertensive|"Hypertensive patients who were randomized to receive amlodipine and losartan placebo for 12 weeks.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
579106|NCT00568178|P3|Participant Flow|Losartan Double Blind Hypertensive|"Hypertensive patients who were randomized to receive losartan and amlodipine placebo for 12 weeks.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
579107|NCT00568178|P2|Participant Flow|Placebo Double Blind Normotensive|"Normotensive participants who were randomized to losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
579108|NCT00568178|P1|Participant Flow|Losartan Double Blind Normortensive|"Normotensive participants who were randomized to losartan.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks; or losartan placebo."
579109|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
579110|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
579111|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
579112|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
579113|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
579114|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
579115|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
579116|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
579117|NCT00568178|O2|Outcome|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
579118|NCT00568178|O1|Outcome|Losartan|Participants were randomized in a 1:1 ratio within each stratum: hypertensive patients (6 to 17 years of age) were randomized to either amlodipine or losartan; normotensive patients (1 to 17 years of age) were randomized to either placebo or losartan. Losartan (or placebo) therapy was administered orally, in tablet or suspension form, at an initial dose of approximately 0.7 mg/kg once daily (up to 50 or 100 mg total daily dose, weight-dependent). Participants who were randomized to losartan were assigned to a normotensive or hypertensive group, based on clinical profile.
579152|NCT00568022|O1|Outcome|All Participants With Measurable Disease and Tumor Response|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥ 1 dose of ixabepilone and/or capecitabine in Cycle 1, completed adequate safety evaluations, and was observed for ≥ 21 days following the first dose or the participant experienced DLT.
579281|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579119|NCT00568178|E4|Reported Event|Enalapril: Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum specified dose of enalapril was 40 mg/day. For participants unable to swallow tablets, or for those who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared. The starting dose of drug and any adjustments during the open-label period were at the discretion of the investigator."
579120|NCT00568178|E3|Reported Event|Losartan Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum dose of losartan was 50 mg/day (if the participant weighed <50 kg) or 100 mg/day (if the participant weighed ≥50 kg) Losartan 25-mg and 50-mg tablets were available for participants able to swallow tablets, and losartan suspension (2.5 mg/ml) was prepared for participants unable to swallow tablets, or for those who weighed <25 kg."
579121|NCT00568178|E2|Reported Event|Amlodipine/Placebo: Double-Blind Base Study|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
579122|NCT00568178|E1|Reported Event|Losartan: Double-Blind Base Study|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
579123|NCT00568087|B3|Baseline|Total|Total of all reporting groups
579124|NCT00568087|B2|Baseline|Placebo|Identical placebo daily for 8 weeks
579125|NCT00568087|B1|Baseline|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
579126|NCT00568087|P2|Participant Flow|Placebo|Identical placebo daily for 8 weeks
579127|NCT00568087|P1|Participant Flow|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
579128|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
579129|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
579130|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
579131|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
579132|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
579133|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
579134|NCT00568087|E2|Reported Event|Placebo|Identical placebo daily for 8 weeks
579135|NCT00568087|E1|Reported Event|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
579136|NCT00568061|B3|Baseline|Total|Total of all reporting groups
579137|NCT00568061|B2|Baseline|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
579138|NCT00568061|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
579139|NCT00568061|P2|Participant Flow|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
579140|NCT00568061|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
579141|NCT00568061|O2|Outcome|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
579142|NCT00568061|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
579143|NCT00568061|E2|Reported Event|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
579144|NCT00568061|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
579145|NCT00568022|B4|Baseline|Total|Total of all reporting groups
579146|NCT00568022|B3|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579147|NCT00568022|B2|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579148|NCT00568022|B1|Baseline|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579149|NCT00568022|P3|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|After receiving Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579150|NCT00568022|P2|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|After receiving Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579221|NCT00567879|B2|Baseline|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579153|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579154|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579155|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579156|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579157|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579158|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579159|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579160|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579161|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579162|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579163|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579164|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579165|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579166|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579167|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579168|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579169|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579170|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579171|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579172|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579173|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579174|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579175|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579176|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579222|NCT00567879|B1|Baseline|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579177|NCT00568022|E3|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579178|NCT00568022|E2|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
579179|NCT00568022|E1|Reported Event|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each treatment cycle.
579180|NCT00567996|B4|Baseline|Total|Total of all reporting groups
579181|NCT00567996|B3|Baseline|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579182|NCT00567996|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579183|NCT00567996|B1|Baseline|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579184|NCT00567996|P3|Participant Flow|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579185|NCT00567996|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579186|NCT00567996|P1|Participant Flow|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579187|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579188|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579189|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579190|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579191|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579192|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579193|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579194|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
581602|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
579195|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579196|NCT00567996|E3|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579197|NCT00567996|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579198|NCT00567996|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
579199|NCT00567892|B3|Baseline|Total|Total of all reporting groups
579200|NCT00567892|B2|Baseline|4 Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
579201|NCT00567892|B1|Baseline|2 Week Treatment|Treatment (either active rTMS or sham)for 2 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 2 weeks
579202|NCT00567892|P4|Participant Flow|Sham Then Active rTMS Treatment (4 Weeks)|Sham treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks Active rTMS Treatment. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
579203|NCT00567892|P3|Participant Flow|Active Then Sham rTMS Treatment (4 Weeks)|Active rTMS Treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks sham.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.One subject had a drop of THI larger than 20 points from baseline after first arm of treatment and did not get the second arm.
579204|NCT00567892|P2|Participant Flow|Sham Then Active rTMS Treatment (2 Weeks)|Sham treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks Active rTMS Treatment.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
579205|NCT00567892|P1|Participant Flow|Active Then Sham rTMS Treatment (2 Weeks)|Active rTMS Treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks sham. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
579206|NCT00567892|O4|Outcome|4-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
579207|NCT00567892|O3|Outcome|4-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
579208|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks).
579209|NCT00567892|O1|Outcome|2-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold)
579210|NCT00567892|O4|Outcome|4-weeks rTMS Sham Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
579211|NCT00567892|O3|Outcome|4-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
579212|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks.
579213|NCT00567892|O1|Outcome|2-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 2 weeks.
579214|NCT00567892|E2|Reported Event|Four Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
579215|NCT00567892|E1|Reported Event|2 Weeks Treatment|Treatment (either active rTMS or sham) for two weeks followed by 2 weeks wash-out then treatment (opposite of first assignment)for two weeks
579216|NCT00567879|B7|Baseline|Total|Total of all reporting groups
579217|NCT00567879|B6|Baseline|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579218|NCT00567879|B5|Baseline|Oral Arm - Schedule B 15mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579219|NCT00567879|B4|Baseline|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
579220|NCT00567879|B3|Baseline|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579282|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579224|NCT00567879|P5|Participant Flow|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579225|NCT00567879|P4|Participant Flow|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
579226|NCT00567879|P3|Participant Flow|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579227|NCT00567879|P2|Participant Flow|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579228|NCT00567879|P1|Participant Flow|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579229|NCT00567879|O6|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579230|NCT00567879|O5|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579231|NCT00567879|O4|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
579232|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579233|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579234|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579235|NCT00567879|O7|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579236|NCT00567879|O6|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579237|NCT00567879|O5|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
579238|NCT00567879|O4|Outcome|Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579239|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579240|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579241|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579242|NCT00567879|E6|Reported Event|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579243|NCT00567879|E5|Reported Event|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
579244|NCT00567879|E4|Reported Event|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
579245|NCT00567879|E3|Reported Event|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579246|NCT00567879|E2|Reported Event|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579247|NCT00567879|E1|Reported Event|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
579248|NCT00567840|B6|Baseline|Total|Total of all reporting groups
579249|NCT00567840|B5|Baseline|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579250|NCT00567840|B4|Baseline|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579251|NCT00567840|B3|Baseline|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579252|NCT00567840|B2|Baseline|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579253|NCT00567840|B1|Baseline|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579254|NCT00567840|P5|Participant Flow|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579255|NCT00567840|P4|Participant Flow|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579256|NCT00567840|P3|Participant Flow|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579257|NCT00567840|P2|Participant Flow|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579258|NCT00567840|P1|Participant Flow|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579259|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579260|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579261|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579262|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579263|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579264|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579265|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579266|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579267|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579268|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579269|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579270|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579271|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579272|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579273|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579274|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579275|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579276|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579277|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579278|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579279|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579280|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579284|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579285|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579286|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579287|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579288|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579289|NCT00567840|E5|Reported Event|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
579290|NCT00567840|E4|Reported Event|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
579291|NCT00567840|E3|Reported Event|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
579292|NCT00567840|E2|Reported Event|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
579293|NCT00567840|E1|Reported Event|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
579294|NCT00567593|B1|Baseline|Rosaglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
579295|NCT00567593|P1|Participant Flow|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
579296|NCT00567593|O1|Outcome|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
579297|NCT00567593|E1|Reported Event|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
579298|NCT00567567|B4|Baseline|Total|Total of all reporting groups
579299|NCT00567567|B3|Baseline|Not Assigned|Patients that either failed during Induction therapy or refused randomization
579300|NCT00567567|B2|Baseline|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579301|NCT00567567|B1|Baseline|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579302|NCT00567567|P3|Participant Flow|Not Assigned|Patients that either failed during Induction therapy or refused randomization
579303|NCT00567567|P2|Participant Flow|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579304|NCT00567567|P1|Participant Flow|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579305|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
579306|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579307|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579308|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
579309|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579310|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579311|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
579312|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579313|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579314|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579315|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579316|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579317|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579318|NCT00567567|O3|Outcome|Not Assigned|Patients that either failed during Induction therapy or refused randomization
579319|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579320|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579321|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579322|NCT00567567|O2|Outcome|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579323|NCT00567567|O1|Outcome|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579324|NCT00567567|E3|Reported Event|Not Assigned|Patients that either failed during Induction therapy or refused randomization
579325|NCT00567567|E2|Reported Event|Tandem HST (CEM), Randomly Assigned|Induction therapy + tandem myeloablative consolidation
579326|NCT00567567|E1|Reported Event|Single HST (CEM)|Induction therapy + single myeloablative consolidation
579327|NCT00567541|B3|Baseline|Total|Total of all reporting groups
579328|NCT00567541|B2|Baseline|Sham BBPM Stimulation|Sham Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
579329|NCT00567541|B1|Baseline|Active BBPM Stimulation|Active Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
579330|NCT00567541|P2|Participant Flow|Sham BBPM Stimulation|"The Battery Powered Microneuromodulator(BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation."
579331|NCT00567541|P1|Participant Flow|Active BBPM Stimulation|"The Battery Powered Microneuromodulator (BBPM) is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) will be programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. therapeutic treatment."
579482|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579332|NCT00567541|O2|Outcome|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
579333|NCT00567541|O1|Outcome|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
579334|NCT00567541|E2|Reported Event|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
579335|NCT00567541|E1|Reported Event|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
579336|NCT00567502|B5|Baseline|Total|Total of all reporting groups
579337|NCT00567502|B4|Baseline|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
579338|NCT00567502|B3|Baseline|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579339|NCT00567502|B2|Baseline|XAGRID+Other (Cytoreductives)|Participants who received XAGRID along with Other cytoreductives drugs at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579340|NCT00567502|B1|Baseline|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
579341|NCT00567502|P4|Participant Flow|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator’s discretion.
579342|NCT00567502|P3|Participant Flow|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579343|NCT00567502|P2|Participant Flow|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579344|NCT00567502|P1|Participant Flow|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion
579345|NCT00567502|O2|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. Other Cytoreductives included Hydroxyurea, Interferonalpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579346|NCT00567502|O1|Outcome|XAGRID|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579347|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579348|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579349|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579350|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579351|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579352|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579353|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579443|NCT00567268|O1|Outcome|Mild|Participants with mild epilepsy who responded to the treatment with gabapentin
579354|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579355|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
579356|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579357|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579358|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579359|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579360|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579361|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579362|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579363|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
579364|NCT00567502|O1|Outcome|XAGRID Taken|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period."
579365|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
579366|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579367|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579368|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
579369|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
579370|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579371|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579372|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
579373|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579374|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
579375|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
579444|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
579376|NCT00567502|E2|Reported Event|Other (Cytoreductives)|"Participants who received other (cytoreductives) from  other (cytoreductives or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."
579377|NCT00567502|E1|Reported Event|XAGRID|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period."
579378|NCT00567476|B3|Baseline|Total|Total of all reporting groups
579379|NCT00567476|B2|Baseline|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579380|NCT00567476|B1|Baseline|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579381|NCT00567476|P2|Participant Flow|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579382|NCT00567476|P1|Participant Flow|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579383|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579384|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579385|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579386|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579387|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579388|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579389|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579403|NCT00567476|E2|Reported Event|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579480|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579390|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579391|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579392|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579393|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579394|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579395|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579396|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579397|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579398|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579399|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579400|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579401|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579402|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579441|NCT00567268|O3|Outcome|Severe|Participants with severe epilepsy who responded to the treatment with gabapentin
579442|NCT00567268|O2|Outcome|Moderate|Participants with moderate epilepsy who responded to the treatment with gabapentin
579481|NCT00567255|O2|Outcome|Placebo|Placebo
579404|NCT00567476|E1|Reported Event|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
579405|NCT00567320|B3|Baseline|Total|Total of all reporting groups
579406|NCT00567320|B2|Baseline|Placebo|This is the Placebo condition
579407|NCT00567320|B1|Baseline|Varenicline|Varenicline 2 mg per day.
579408|NCT00567320|P2|Participant Flow|Placebo|This is the Placebo condition
579409|NCT00567320|P1|Participant Flow|Varenicline|Varenicline 2 mg per day.
579410|NCT00567320|O2|Outcome|Placebo|This is the Placebo condition
579411|NCT00567320|O1|Outcome|Varenicline|Varenicline 2 mg per day.
579412|NCT00567320|E2|Reported Event|Placebo|This is the Placebo condition
579413|NCT00567320|E1|Reported Event|Varenicline|Varenicline 2 mg per day.
579414|NCT00567307|B3|Baseline|Total|Total of all reporting groups
579415|NCT00567307|B2|Baseline|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
579416|NCT00567307|B1|Baseline|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
579417|NCT00567307|P2|Participant Flow|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
579418|NCT00567307|P1|Participant Flow|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
579419|NCT00567307|O2|Outcome|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
579420|NCT00567307|O1|Outcome|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
579421|NCT00567307|E2|Reported Event|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
579422|NCT00567307|E1|Reported Event|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
579423|NCT00567268|B1|Baseline|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579424|NCT00567268|P1|Participant Flow|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579425|NCT00567268|O2|Outcome|Absence of Non-Drug Therapy|Participants without non-drug therapy who responded to treatment with gabapentin
579426|NCT00567268|O1|Outcome|Presence of Non-Drug Therapy|Participants with non-drug therapy who responded to treatment with gabapentin
579427|NCT00567268|O6|Outcome|Unkown|Participants with unkown baseline creatinine clearance
579428|NCT00567268|O5|Outcome|CLcr <5 mL/Min|Participants with baseline creatinine clearance <5 mL/min
579429|NCT00567268|O4|Outcome|CLcr >=5 and <15 mL/Min|Participants with baseline creatinine clearance >=5 and <15 mL/min
579430|NCT00567268|O3|Outcome|CLcr >=15 and <30 mL/Min|Participants with baseline creatinine clearance >=15 and <30 mL/min
579431|NCT00567268|O2|Outcome|CLcr >=30 and <60 mL/Min|Participants with baseline creatinine clearance >=30 and <60 mL/min
579432|NCT00567268|O1|Outcome|CLcr >=60 mL/Min|Participants with baseline creatinine clearance >=60 mL/min
579433|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
579434|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
579435|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
579436|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
579437|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
579438|NCT00567268|O3|Outcome|Unknown|Participants with unknown frequency of baseline episodes who responded to the treatment with gabapentin
579439|NCT00567268|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8 who responded to the treatment with gabapentin
579440|NCT00567268|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure below 8 who responded to the treatment with gabapentin
579483|NCT00567255|O2|Outcome|Placebo|Placebo
579445|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age who responded to the treatment with gabapentin
579446|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age who responded to the treatment with gabapentin
579447|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age who responded to the treatment with gabapentin
579448|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age who responded to the treatment with gabapentin
579449|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age who responded to the treatment with gabapentin
579450|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age who responded to the treatment with gabapentin
579451|NCT00567268|O2|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
579452|NCT00567268|O1|Outcome|Age <65 Years|Participants <65 years of age who responded to the treatment with gabapentin
579453|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
579454|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
579455|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
579456|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
579457|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
579458|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
579459|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
579460|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
579461|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
579462|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
579463|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
579464|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
579465|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579466|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579467|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579468|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579469|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579470|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579471|NCT00567268|E1|Reported Event|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
579472|NCT00567255|B3|Baseline|Total|Total of all reporting groups
579473|NCT00567255|B2|Baseline|Placebo|Placebo
579474|NCT00567255|B1|Baseline|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579475|NCT00567255|P2|Participant Flow|Placebo|Placebo
579476|NCT00567255|P1|Participant Flow|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579477|NCT00567255|O2|Outcome|Placebo|Placebo
579478|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579479|NCT00567255|O2|Outcome|Placebo|Placebo
579484|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579485|NCT00567255|O2|Outcome|Placebo|Placebo
579486|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579487|NCT00567255|O2|Outcome|Placebo|Placebo
579488|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579489|NCT00567255|O2|Outcome|Placebo|Placebo
579490|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579491|NCT00567255|O2|Outcome|Placebo|Placebo
579492|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579493|NCT00567255|O2|Outcome|Placebo|Placebo
579494|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579495|NCT00567255|O2|Outcome|Placebo|Placebo
579496|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579497|NCT00567255|O2|Outcome|Placebo|Placebo
579498|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579499|NCT00567255|O2|Outcome|Placebo|Placebo
579500|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579501|NCT00567255|O2|Outcome|Placebo|Placebo
579502|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579503|NCT00567255|O2|Outcome|Placebo|Placebo
579504|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579505|NCT00567255|O2|Outcome|Placebo|Placebo
579506|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579507|NCT00567255|O2|Outcome|Placebo|Placebo
579508|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579509|NCT00567255|O2|Outcome|Placebo|Placebo
579510|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579511|NCT00567255|O2|Outcome|Placebo|Placebo
579512|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579513|NCT00567255|O2|Outcome|Placebo|Placebo
579514|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579515|NCT00567255|O2|Outcome|Placebo|Placebo
579516|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
579517|NCT00567255|E2|Reported Event|Placebo|Placebo
579518|NCT00567255|E1|Reported Event|NB32/48|"Naltrexone SR 32 mg/bupropion SR 360 mg/day or naltrexone SR 48 mg/bupropion SR 360 mg/day~Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).~NB32/48 group includes all participants in the safety analysis set randomized to NB32 at baseline, regardless of re-randomization status."
579519|NCT00567242|B3|Baseline|Total|Total of all reporting groups
579520|NCT00567242|B2|Baseline|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
579521|NCT00567242|B1|Baseline|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
579522|NCT00567242|P2|Participant Flow|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
579523|NCT00567242|P1|Participant Flow|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
579524|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
579525|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
579526|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
579527|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
579528|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
579529|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
579530|NCT00567242|E2|Reported Event|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
579531|NCT00567242|E1|Reported Event|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
579532|NCT00567229|B1|Baseline|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
579533|NCT00567229|P1|Participant Flow|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
579674|NCT00566982|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579534|NCT00567229|O1|Outcome|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
579535|NCT00567229|E1|Reported Event|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
579536|NCT00567190|B3|Baseline|Total|Total of all reporting groups
579537|NCT00567190|B2|Baseline|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579538|NCT00567190|B1|Baseline|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579539|NCT00567190|P2|Participant Flow|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579540|NCT00567190|P1|Participant Flow|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579541|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579542|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579543|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579544|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579545|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579546|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579547|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579548|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579549|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579550|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579551|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579552|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579553|NCT00567190|E3|Reported Event|Crossover From Placebo to Pertuzumab|Forty-eight of 406 patients (11.8%) randomized to the placebo treatment group whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2012. Patients received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w until investigator-assessed radiographic or clinical evidence of PD, unacceptable toxicity, or withdrawal of consent. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol.
579554|NCT00567190|E2|Reported Event|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
579555|NCT00567190|E1|Reported Event|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles. For the 48 patients that crossed over to the pertuzumab treatment group, AEs were analyzed from the day of their first placebo dose (Day 1) through the day just prior to their first pertuzumab dose. Any AEs occurring on, or after, the day of their first dose of pertuzumab were included in the Crossover treatment group analysis.
579556|NCT00567164|B4|Baseline|Total|Total of all reporting groups
579557|NCT00567164|B3|Baseline|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579558|NCT00567164|B2|Baseline|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579734|NCT00566930|E3|Reported Event|Spinal Manipulation and Exercises|Spinal manipulation + exercises
579559|NCT00567164|B1|Baseline|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579560|NCT00567164|P3|Participant Flow|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579561|NCT00567164|P2|Participant Flow|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579562|NCT00567164|P1|Participant Flow|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579563|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579564|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579565|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579566|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579567|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579568|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579569|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579570|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579571|NCT00567164|O1|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579572|NCT00567164|O2|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579573|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579574|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579575|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579576|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579577|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579578|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579579|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579580|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579581|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579582|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579583|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579675|NCT00566982|P1|Participant Flow|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579676|NCT00566982|O4|Outcome|Subjects on Ospemifene 60 mg/Day (Week 52)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579584|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579585|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579586|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579587|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579588|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579589|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579590|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579591|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579592|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579593|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579594|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579595|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579677|NCT00566982|O3|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579678|NCT00566982|O2|Outcome|Subjects on Placebo (Week 52)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579596|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579597|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579598|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579599|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579600|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579601|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579602|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579603|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579604|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579605|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579606|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579607|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579679|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579680|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579608|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579609|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579610|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579611|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579612|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579613|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579614|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579615|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579616|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579617|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579618|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579619|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579681|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579682|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579620|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579621|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579622|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579623|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579624|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579625|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579626|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579627|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579628|NCT00567164|O2|Outcome|Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2|Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579629|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579630|NCT00567164|E3|Reported Event|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
579683|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579684|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579685|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579735|NCT00566930|E2|Reported Event|Spinal Manipulation|spinal manipulation
579631|NCT00567164|E2|Reported Event|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
579632|NCT00567164|E1|Reported Event|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
579633|NCT00567112|B1|Baseline|All Randomized|Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.
579634|NCT00567112|P3|Participant Flow|Treatment Group BCD|"Period 1: Not Applicable~Period 2: OCT (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
579635|NCT00567112|P2|Participant Flow|Treatment Group BACD|"Period 1: OCT (fasted)~Period 2: DFC (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
579636|NCT00567112|P1|Participant Flow|Treatment Group ABCD|"Period 1: Dry Filled Capsule (DFC) (fasted)~Period 2: Oral Compressed Tablet (OCT) (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
579637|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
579638|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579639|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
579640|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579641|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
579642|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579643|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
579644|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579645|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
579646|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579647|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
579648|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579649|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
579650|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579651|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
579652|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579653|NCT00567112|E4|Reported Event|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
579654|NCT00567112|E3|Reported Event|OCT (Before Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast
579655|NCT00567112|E2|Reported Event|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
579656|NCT00567112|E1|Reported Event|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
579657|NCT00567008|B3|Baseline|Total|Total of all reporting groups
579658|NCT00567008|B2|Baseline|Placebo|Placebo
579659|NCT00567008|B1|Baseline|Varenicline|Varenicline (Chantix)
579660|NCT00567008|P2|Participant Flow|Placebo|Placebo
579661|NCT00567008|P1|Participant Flow|Varenicline 2mg/Day|Varenicline (Chantix)
579662|NCT00567008|O2|Outcome|Placebo|Placebo
579663|NCT00567008|O1|Outcome|Varenicline|Varenicline (Chantix)
579664|NCT00567008|E2|Reported Event|Placebo|Placebo
579665|NCT00567008|E1|Reported Event|Varenicline|Varenicline (Chantix)
579666|NCT00566995|B1|Baseline|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
579667|NCT00566995|P1|Participant Flow|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
579668|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
579669|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
579670|NCT00566995|E1|Reported Event|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
579671|NCT00566982|B3|Baseline|Total|Total of all reporting groups
579672|NCT00566982|B2|Baseline|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579673|NCT00566982|B1|Baseline|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
581603|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
579686|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579687|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579688|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579689|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579690|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579691|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579692|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579693|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579694|NCT00566982|E2|Reported Event|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
579695|NCT00566982|E1|Reported Event|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
579696|NCT00566969|B4|Baseline|Total|Total of all reporting groups
579697|NCT00566969|B3|Baseline|Carvedilol 50 mg|"To be compared to placebo and Carvedilol 25 mg~Carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
579698|NCT00566969|B2|Baseline|Carvedilol 25 mg|"To be compared to placebo and Carvedilol 50 mg~carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
579699|NCT00566969|B1|Baseline|Sugar Pill|"To be compared to active drug~sugar pill: Subjects randomized to placebo, carvedilol 25mg or 50mg"
579700|NCT00566969|P3|Participant Flow|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
579701|NCT00566969|P2|Participant Flow|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
579702|NCT00566969|P1|Participant Flow|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
579703|NCT00566969|O3|Outcome|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
579704|NCT00566969|O2|Outcome|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
579705|NCT00566969|O1|Outcome|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
579706|NCT00566969|E3|Reported Event|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
579707|NCT00566969|E2|Reported Event|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
579708|NCT00566969|E1|Reported Event|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
579709|NCT00566943|B3|Baseline|Total|Total of all reporting groups
579710|NCT00566943|B2|Baseline|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
579711|NCT00566943|B1|Baseline|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
579712|NCT00566943|P2|Participant Flow|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
579713|NCT00566943|P1|Participant Flow|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
579714|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm|PSD Veritas is used as a buttress on stomach and/or GJ anastomosis.
579715|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines
579716|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm Linear|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
579717|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
579718|NCT00566943|O2|Outcome|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
579719|NCT00566943|O1|Outcome|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
579720|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Group|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
579721|NCT00566943|O1|Outcome|Number of Subjects in Control Group|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
579722|NCT00566943|E2|Reported Event|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
579723|NCT00566943|E1|Reported Event|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
579724|NCT00566930|B4|Baseline|Total|Total of all reporting groups
579725|NCT00566930|B3|Baseline|Spinal Manipulation and Exercises|Spinal manipulation + exercises
579726|NCT00566930|B2|Baseline|Spinal Manipulation|spinal manipulation
579727|NCT00566930|B1|Baseline|Control|control group with no treatment only regular assessment appointments
579728|NCT00566930|P3|Participant Flow|Spinal Manipulation and Exercises|Spinal manipulation + exercises
579729|NCT00566930|P2|Participant Flow|Spinal Manipulation|spinal manipulation
579730|NCT00566930|P1|Participant Flow|Control|control group with no treatment only regular assessment appointments
579731|NCT00566930|O3|Outcome|Spinal Manipulation and Exercises|Spinal manipulation + exercises
579732|NCT00566930|O2|Outcome|Spinal Manipulation|spinal manipulation
579733|NCT00566930|O1|Outcome|Control|control group with no treatment only regular assessment appointments
579736|NCT00566930|E1|Reported Event|Control|control group with no treatment only regular assessment appointments
579737|NCT00566852|B3|Baseline|Total|Total of all reporting groups
579738|NCT00566852|B2|Baseline|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579739|NCT00566852|B1|Baseline|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579740|NCT00566852|P2|Participant Flow|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579741|NCT00566852|P1|Participant Flow|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579742|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579743|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579744|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579745|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579746|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579747|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579748|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579749|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579750|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579751|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579752|NCT00566852|O2|Outcome|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579753|NCT00566852|O1|Outcome|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579754|NCT00566852|E2|Reported Event|WBRT+Placebo|Whole brain radiation therapy (WBRT) and placebo
579755|NCT00566852|E1|Reported Event|WBRT+Memantine|Whole brain radiation therapy (WBRT) and memantine
579756|NCT00566735|B3|Baseline|Total|Total of all reporting groups
579757|NCT00566735|B2|Baseline|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
579758|NCT00566735|B1|Baseline|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
579759|NCT00566735|P2|Participant Flow|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
579760|NCT00566735|P1|Participant Flow|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
579761|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
579762|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
579763|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
579764|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
579765|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
579766|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
579767|NCT00566735|E2|Reported Event|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
579768|NCT00566735|E1|Reported Event|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
579769|NCT00566722|B4|Baseline|Total|Total of all reporting groups
579770|NCT00566722|B3|Baseline|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579771|NCT00566722|B2|Baseline|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579772|NCT00566722|B1|Baseline|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579773|NCT00566722|P3|Participant Flow|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579774|NCT00566722|P2|Participant Flow|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579775|NCT00566722|P1|Participant Flow|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579776|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579777|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579778|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579779|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579780|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579825|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579826|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579781|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579782|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579783|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579784|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579785|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579786|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579787|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579788|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579789|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579827|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579828|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579790|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579791|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579792|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579793|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579794|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579795|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579796|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579797|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579798|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579829|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579830|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579799|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579800|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579801|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579802|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579803|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579804|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579805|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579806|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|
579807|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|
579808|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|
579809|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579810|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579831|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579811|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579812|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579813|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579814|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579815|NCT00566722|E3|Reported Event|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579816|NCT00566722|E2|Reported Event|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
579817|NCT00566722|E1|Reported Event|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
579818|NCT00566709|B3|Baseline|Total|Total of all reporting groups
579819|NCT00566709|B2|Baseline|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579820|NCT00566709|B1|Baseline|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579821|NCT00566709|P2|Participant Flow|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579822|NCT00566709|P1|Participant Flow|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579823|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579824|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579882|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579832|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579833|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579834|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579835|NCT00566709|E2|Reported Event|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579836|NCT00566709|E1|Reported Event|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
579837|NCT00566696|B1|Baseline|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579838|NCT00566696|P1|Participant Flow|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579839|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579840|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579841|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579842|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579843|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579844|NCT00566696|E1|Reported Event|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
579845|NCT00566631|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579846|NCT00566631|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579847|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579848|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579849|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579850|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579883|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579851|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579852|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579853|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579854|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579855|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579856|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579857|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579858|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579859|NCT00566631|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
579860|NCT00566579|B3|Baseline|Total|Total of all reporting groups
579861|NCT00566579|B2|Baseline|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579862|NCT00566579|B1|Baseline|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579863|NCT00566579|P2|Participant Flow|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579864|NCT00566579|P1|Participant Flow|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579865|NCT00566579|O2|Outcome|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579866|NCT00566579|O1|Outcome|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579867|NCT00566579|E2|Reported Event|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579868|NCT00566579|E1|Reported Event|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
579869|NCT00566527|B4|Baseline|Total|Total of all reporting groups
579870|NCT00566527|B3|Baseline|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579871|NCT00566527|B2|Baseline|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579872|NCT00566527|B1|Baseline|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579873|NCT00566527|P3|Participant Flow|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579874|NCT00566527|P2|Participant Flow|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579875|NCT00566527|P1|Participant Flow|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579876|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579877|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579878|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579879|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579880|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579881|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579884|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579885|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579886|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579887|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579888|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579889|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579890|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579891|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579892|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579893|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579894|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579895|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579896|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579897|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579898|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579899|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579900|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579901|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579902|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579903|NCT00566527|O3|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579904|NCT00566527|O2|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579905|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579906|NCT00566527|O2|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579907|NCT00566527|O1|Outcome|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579908|NCT00566527|O2|Outcome|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579909|NCT00566527|O1|Outcome|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579910|NCT00566527|E3|Reported Event|Arm 3: ProQuad® at 12 and 15 Months|Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.
579911|NCT00566527|E2|Reported Event|Arm 2: ProQuad® at 11 and 14 Months|Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
579912|NCT00566527|E1|Reported Event|Arm 1: ProQuad® at 9 and 12 Months|Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.
579913|NCT00566501|B3|Baseline|Total|Total of all reporting groups
579914|NCT00566501|B2|Baseline|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
579915|NCT00566501|B1|Baseline|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
579916|NCT00566501|P2|Participant Flow|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
579917|NCT00566501|P1|Participant Flow|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
579918|NCT00566501|O2|Outcome|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
580044|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
579919|NCT00566501|O1|Outcome|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
579920|NCT00566501|E2|Reported Event|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
579921|NCT00566501|E1|Reported Event|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
579922|NCT00566462|B3|Baseline|Total|Total of all reporting groups
579923|NCT00566462|B2|Baseline|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579924|NCT00566462|B1|Baseline|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579925|NCT00566462|P2|Participant Flow|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579926|NCT00566462|P1|Participant Flow|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579927|NCT00566462|O2|Outcome|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579928|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579929|NCT00566462|O2|Outcome|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579930|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579931|NCT00566462|E2|Reported Event|Placebo|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579932|NCT00566462|E1|Reported Event|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
579933|NCT00566254|B3|Baseline|Total|Total of all reporting groups
579934|NCT00566254|B2|Baseline|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579935|NCT00566254|B1|Baseline|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579936|NCT00566254|P2|Participant Flow|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579937|NCT00566254|P1|Participant Flow|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579938|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579939|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579940|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579941|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579942|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
581604|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
579943|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579944|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579945|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579946|NCT00566254|E2|Reported Event|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579947|NCT00566254|E1|Reported Event|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
579948|NCT00566150|B3|Baseline|Total|Total of all reporting groups
579949|NCT00566150|B2|Baseline|Placebo|Subjects assigned to placebo control group.
579950|NCT00566150|B1|Baseline|Levetiracetam|Subjects on active study medication.
579951|NCT00566150|P2|Participant Flow|Placebo|Subjects assigned to placebo control group.
579952|NCT00566150|P1|Participant Flow|Levetiracetam|Subjects on active study medication.
579953|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
579954|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
579955|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
579956|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
579957|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
579958|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
579959|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
579960|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
579961|NCT00566150|E2|Reported Event|Placebo|Subjects assigned to placebo control group.
579962|NCT00566150|E1|Reported Event|Levetiracetam|Subjects on active study medication.
579963|NCT00566111|B3|Baseline|Total|Total of all reporting groups
579964|NCT00566111|B2|Baseline|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579965|NCT00566111|B1|Baseline|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579966|NCT00566111|P2|Participant Flow|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579967|NCT00566111|P1|Participant Flow|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579968|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579969|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579970|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579971|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579972|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579973|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579974|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579975|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579976|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579977|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579978|NCT00566111|E2|Reported Event|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
579979|NCT00566111|E1|Reported Event|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
579980|NCT00566020|B1|Baseline|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579981|NCT00566020|P2|Participant Flow|Lamotrigine - Long-term Administration Phase|Lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579982|NCT00566020|P1|Participant Flow|Lamotrigine - Dosage Adjustment Phase|Lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation
579983|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579984|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580045|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
579985|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579986|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579987|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579988|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579989|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579990|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579991|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579992|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579993|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579994|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579995|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579996|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579997|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579998|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
579999|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580000|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580001|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580002|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580003|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580620|NCT00564447|B8|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
580004|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580005|NCT00566020|E1|Reported Event|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
580006|NCT00565812|B4|Baseline|Total|Total of all reporting groups
580007|NCT00565812|B3|Baseline|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580008|NCT00565812|B2|Baseline|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580009|NCT00565812|B1|Baseline|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580010|NCT00565812|P3|Participant Flow|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580011|NCT00565812|P2|Participant Flow|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580012|NCT00565812|P1|Participant Flow|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580013|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580014|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580015|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580016|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580017|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580018|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580019|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580020|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580021|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580022|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580023|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580024|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580025|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580026|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580027|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580028|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580029|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580030|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580031|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580032|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580033|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580034|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580035|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580036|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580037|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580038|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580039|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580040|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580041|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580042|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580043|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
581605|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
580046|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580047|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580048|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580049|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580050|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580051|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580052|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580053|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580054|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580055|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580056|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580057|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580058|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580059|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580060|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580061|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580062|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580063|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580064|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580065|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580066|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580067|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580068|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580069|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580070|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580071|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580072|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580073|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580074|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580075|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580076|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580077|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580078|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580079|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580080|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580081|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580082|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580083|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580084|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580085|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580086|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580087|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580621|NCT00564447|B7|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
580088|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580089|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580090|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580091|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580092|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580093|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580094|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580095|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580096|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580097|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580098|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580099|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580100|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580101|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580102|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580103|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580104|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580105|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580106|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580107|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580108|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580109|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580110|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580111|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580112|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580113|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580114|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580115|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580116|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580117|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580118|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580119|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580120|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580121|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580122|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580123|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580124|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580125|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580126|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580127|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580128|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580129|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580622|NCT00564447|B6|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
580130|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580131|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580132|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580133|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580134|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580135|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580136|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580137|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580138|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580139|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580140|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580141|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580142|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580143|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580144|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580145|NCT00565812|E3|Reported Event|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
580146|NCT00565812|E2|Reported Event|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
580147|NCT00565812|E1|Reported Event|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
580148|NCT00565747|B3|Baseline|Total|Total of all reporting groups
580149|NCT00565747|B2|Baseline|Control Culture|Culture without GM-CSF
580150|NCT00565747|B1|Baseline|Test Culture|Culture with 2 ng/ml GM-CSF
580151|NCT00565747|P2|Participant Flow|Control Culture|Culture without GM-CSF
580152|NCT00565747|P1|Participant Flow|Test Culture|Culture with 2 ng/ml GM-CSF
580153|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
580154|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
580155|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
580156|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
580157|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
580158|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
580159|NCT00565747|E2|Reported Event|Control Culture|Culture without GM-CSF
580160|NCT00565747|E1|Reported Event|Test Culture|Culture with 2 ng/ml GM-CSF
580161|NCT00565721|B1|Baseline|Safety With Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
580162|NCT00565721|P1|Participant Flow|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
580163|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
580164|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
580165|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
580166|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
580167|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
580168|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
580169|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
580170|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
580623|NCT00564447|B5|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
580171|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
580172|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
580173|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
580174|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
580175|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
580176|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.
580177|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
580178|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
580179|NCT00565721|E1|Reported Event|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
580180|NCT00565643|B3|Baseline|Total|Total of all reporting groups
580181|NCT00565643|B2|Baseline|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580182|NCT00565643|B1|Baseline|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
580183|NCT00565643|P2|Participant Flow|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580184|NCT00565643|P1|Participant Flow|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
580185|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580186|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
580187|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580188|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
580189|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580190|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
580191|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580192|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
580193|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580194|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
580195|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580196|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
580197|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580198|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
580199|NCT00565643|E2|Reported Event|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
580200|NCT00565643|E1|Reported Event|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
580201|NCT00565617|B1|Baseline|Epidural Cortical Stimulation for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.~For further description of arm please refer to published paper Ziad Nahas, Berry S. Anderson, Jeff Borckardt, Ashley B. Arana, Mark S. George, Scott T. Reeves, and Istvan Takacs Bilateral Epidural Prefrontal Cortical Stimulation for Treatment- Resistant Depression Biological Psychiatry. 2010"
580202|NCT00565617|P1|Participant Flow|Epidural Cortical Stimulation Device for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles."
580253|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580203|NCT00565617|O1|Outcome|Epidural Cortical Stimulation for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles."
580204|NCT00565617|E1|Reported Event|Epidural Cortical Stimulation for Depression|"Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46.~Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles."
580205|NCT00565604|B1|Baseline|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
580206|NCT00565604|P1|Participant Flow|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
580207|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
580208|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
580209|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
580210|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
580211|NCT00565604|E1|Reported Event|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
580212|NCT00565461|B5|Baseline|Total|Total of all reporting groups
580213|NCT00565461|B4|Baseline|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580214|NCT00565461|B3|Baseline|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580215|NCT00565461|B2|Baseline|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580216|NCT00565461|B1|Baseline|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580217|NCT00565461|P4|Participant Flow|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580218|NCT00565461|P3|Participant Flow|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580219|NCT00565461|P2|Participant Flow|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580220|NCT00565461|P1|Participant Flow|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580221|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
580222|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
580223|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
580224|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
580225|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
580226|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
580227|NCT00565461|E4|Reported Event|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580624|NCT00564447|B4|Baseline|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
580228|NCT00565461|E3|Reported Event|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580229|NCT00565461|E2|Reported Event|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580230|NCT00565461|E1|Reported Event|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
580231|NCT00565448|B3|Baseline|Total|Total of all reporting groups
580232|NCT00565448|B2|Baseline|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
580233|NCT00565448|B1|Baseline|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
580234|NCT00565448|P2|Participant Flow|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
580235|NCT00565448|P1|Participant Flow|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
580236|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
580237|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
580238|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
580239|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
580240|NCT00565448|O1|Outcome|Docetaxel/Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
580241|NCT00565448|O2|Outcome|Cisplatin/5-FU|Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
580242|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
580243|NCT00565448|E2|Reported Event|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
580244|NCT00565448|E1|Reported Event|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
580245|NCT00565409|B1|Baseline|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580246|NCT00565409|P4|Participant Flow|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
580247|NCT00565409|P3|Participant Flow|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
580248|NCT00565409|P2|Participant Flow|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
580249|NCT00565409|P1|Participant Flow|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580250|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580251|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580252|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
581606|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
580254|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580255|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580256|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580257|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580258|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580259|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580260|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580261|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580262|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580263|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580264|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580265|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580266|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580267|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580268|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580269|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580270|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580271|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580272|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580273|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580274|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580275|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580276|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580277|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580625|NCT00564447|B3|Baseline|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
580278|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580279|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580280|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580281|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580282|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580283|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580284|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580285|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580286|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580287|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580288|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580289|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580290|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580291|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580292|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580293|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580294|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580295|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580296|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580297|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580298|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580299|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580300|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580626|NCT00564447|B2|Baseline|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
580301|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580302|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580303|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580304|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580305|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580306|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580307|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580308|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580309|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580310|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580311|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580312|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580313|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580314|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580315|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580316|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580317|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580318|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580319|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580320|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580321|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580322|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580323|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580627|NCT00564447|B1|Baseline|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
580324|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580325|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580326|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580327|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580328|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580329|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580330|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580331|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580332|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580333|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580334|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580335|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580336|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580337|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580338|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580339|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580340|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580341|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580342|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580343|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580344|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580345|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
580346|NCT00565409|E4|Reported Event|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
580628|NCT00564447|P8|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
580347|NCT00565409|E3|Reported Event|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
580348|NCT00565409|E2|Reported Event|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
580349|NCT00565409|E1|Reported Event|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
580350|NCT00565370|B1|Baseline|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
580351|NCT00565370|P1|Participant Flow|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2
580352|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
580353|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
580354|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
580355|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
580356|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
580357|NCT00565370|E1|Reported Event|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
580358|NCT00565266|B1|Baseline|All Participants|All participants randomized into the six-sequence crossover study
580359|NCT00565266|P1|Participant Flow|All Participants|"All participants randomized into the six-sequence crossover study. All TALC participants underwent three 16-week treatment periods:~tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~beclomethasone dipropionate 160 mcg twice daily (2xICS)"
580360|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580361|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580362|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580363|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580364|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580365|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580366|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580367|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580368|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580369|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580370|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580371|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580372|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580373|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580374|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580375|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580376|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580377|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580378|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580379|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580380|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580381|NCT00565266|E3|Reported Event|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
580382|NCT00565266|E2|Reported Event|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580383|NCT00565266|E1|Reported Event|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
580384|NCT00565136|B1|Baseline|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580385|NCT00565136|P1|Participant Flow|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580386|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580387|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580388|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580629|NCT00564447|P7|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
580389|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580390|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580391|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580392|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580393|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580394|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580395|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580396|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580397|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580398|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580399|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580400|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580401|NCT00565136|E1|Reported Event|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
580402|NCT00565110|B3|Baseline|Total|Total of all reporting groups
580403|NCT00565110|B2|Baseline|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
580404|NCT00565110|B1|Baseline|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
580405|NCT00565110|P2|Participant Flow|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
580406|NCT00565110|P1|Participant Flow|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
580407|NCT00565110|O2|Outcome|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
580408|NCT00565110|O1|Outcome|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
580409|NCT00565110|O2|Outcome|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
580513|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
580410|NCT00565110|O1|Outcome|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
580411|NCT00565110|E2|Reported Event|ADAPt-C Intervention|Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
580412|NCT00565110|E1|Reported Event|Enhanced Usual Care|EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
580413|NCT00565084|B1|Baseline|Overall Study|
580414|NCT00565084|P3|Participant Flow|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
580415|NCT00565084|P2|Participant Flow|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
580416|NCT00565084|P1|Participant Flow|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
580417|NCT00565084|O3|Outcome|Placebo 2|Second Single dose placebo
580418|NCT00565084|O2|Outcome|Placebo 1|First Single dose placebo
580419|NCT00565084|O1|Outcome|Ibuprofen|Single dose ibuprofen 800 mg
580420|NCT00565084|E3|Reported Event|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
580421|NCT00565084|E2|Reported Event|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
580422|NCT00565084|E1|Reported Event|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
580423|NCT00565058|B3|Baseline|Total|Total of all reporting groups
580424|NCT00565058|B2|Baseline|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
580425|NCT00565058|B1|Baseline|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
580426|NCT00565058|P2|Participant Flow|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
580427|NCT00565058|P1|Participant Flow|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
580428|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
580429|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
580430|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
580431|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
580432|NCT00565058|E2|Reported Event|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
580433|NCT00565058|E1|Reported Event|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
580434|NCT00565045|B3|Baseline|Total|Total of all reporting groups
580435|NCT00565045|B2|Baseline|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580436|NCT00565045|B1|Baseline|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580437|NCT00565045|P2|Participant Flow|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580438|NCT00565045|P1|Participant Flow|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580439|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580440|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580441|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580442|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580443|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580444|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580445|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580446|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580447|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580448|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580449|NCT00565045|E2|Reported Event|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
580450|NCT00565045|E1|Reported Event|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
580451|NCT00564954|B3|Baseline|Total|Total of all reporting groups
580452|NCT00564954|B2|Baseline|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
580453|NCT00564954|B1|Baseline|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
580454|NCT00564954|P2|Participant Flow|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
580455|NCT00564954|P1|Participant Flow|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
580456|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
580457|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
580458|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
581607|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
580459|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
580460|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
580461|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
580462|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
580463|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
580464|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
580465|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
580466|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
580467|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
580468|NCT00564954|E2|Reported Event|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
580469|NCT00564954|E1|Reported Event|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
580470|NCT00564902|B4|Baseline|Total|Total of all reporting groups
580471|NCT00564902|B3|Baseline|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580472|NCT00564902|B2|Baseline|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580473|NCT00564902|B1|Baseline|Lutein|Lutein 9 mg per day
580474|NCT00564902|P3|Participant Flow|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580475|NCT00564902|P2|Participant Flow|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580476|NCT00564902|P1|Participant Flow|Lutein|Lutein 9 mg per day
580477|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580478|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580479|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580480|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580481|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580482|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580483|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580484|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580485|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580486|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580487|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580488|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580489|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580490|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580491|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580492|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580493|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580494|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580495|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580496|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580497|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580498|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580499|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580500|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580501|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580502|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580503|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
580504|NCT00564902|E3|Reported Event|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
580505|NCT00564902|E2|Reported Event|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
580506|NCT00564902|E1|Reported Event|Lutein|Lutein 9 mg per day
580507|NCT00564889|B1|Baseline|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
580508|NCT00564889|P1|Participant Flow|Len/Cyc/Dex|"Lenalidomide (Len) 15mg daily (days 1-21)~Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15)~Dexamethasone (Dex) 40 mg weekly"
580509|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
580510|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
580511|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
580512|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
580514|NCT00564889|E1|Reported Event|Len/Cyc/Dex|Dexamethasone (Dex) 40 mg weekly
580515|NCT00564876|B1|Baseline|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
580516|NCT00564876|P1|Participant Flow|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
580517|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
580518|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
580519|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
580520|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
580521|NCT00564876|E1|Reported Event|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
580522|NCT00564850|B1|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580523|NCT00564850|P1|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580524|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580525|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580526|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580527|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580528|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580529|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580530|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580531|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580532|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580533|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580534|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580535|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580536|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580537|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580538|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580539|NCT00564850|E1|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
580561|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580562|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
580563|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580564|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580565|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
580540|NCT00564733|B1|Baseline|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
580541|NCT00564733|P1|Participant Flow|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
580542|NCT00564733|O1|Outcome|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
580543|NCT00564733|E1|Reported Event|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
580544|NCT00564681|B5|Baseline|Total|Total of all reporting groups
580545|NCT00564681|B4|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
580546|NCT00564681|B3|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
580547|NCT00564681|B2|Baseline|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
580548|NCT00564681|B1|Baseline|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
580549|NCT00564681|P4|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
580550|NCT00564681|P3|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
580551|NCT00564681|P2|Participant Flow|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
580552|NCT00564681|P1|Participant Flow|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
580553|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
580554|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580555|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580556|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
580557|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580558|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580559|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
580560|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580619|NCT00564447|B9|Baseline|Total|Total of all reporting groups
580566|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580567|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
580568|NCT00564681|E4|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
580569|NCT00564681|E3|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
580570|NCT00564681|E2|Reported Event|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
580571|NCT00564681|E1|Reported Event|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
580572|NCT00564629|B3|Baseline|Total|Total of all reporting groups
580573|NCT00564629|B2|Baseline|IV APAP 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g of acetaminophen in 100 ml of intravenous solution and oral placebo as the study treatment
580574|NCT00564629|B1|Baseline|PO APAP 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen and 100 ml of intravenous placebo solution as the study treatment
580575|NCT00564629|P2|Participant Flow|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
580576|NCT00564629|P1|Participant Flow|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
580577|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580578|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580579|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580580|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580581|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580582|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580583|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580584|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580585|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580586|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580587|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580588|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580589|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580590|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580591|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580592|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580593|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
580594|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
580595|NCT00564629|E2|Reported Event|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
580596|NCT00564629|E1|Reported Event|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
580597|NCT00564486|B4|Baseline|Total|Total of all reporting groups
580598|NCT00564486|B3|Baseline|IV Acetaminophen 650 mg|All subjects randomized to receive IV Acetaminophen 650 mg
580599|NCT00564486|B2|Baseline|IV Acetaminophen 1 gm|All subjects randomized to receive IV Acetaminophen 1 gm
580600|NCT00564486|B1|Baseline|IV Placebo|All subjects randomized to receive IV Placebo 100 ml and IV placebo 65 ml groups combined
580601|NCT00564486|P4|Participant Flow|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
580602|NCT00564486|P3|Participant Flow|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
580603|NCT00564486|P2|Participant Flow|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
580604|NCT00564486|P1|Participant Flow|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
580605|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours (6 doses total)
580606|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm every 6 hours for 24 hours (4 doses total)
580607|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
580608|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours
580609|NCT00564486|O2|Outcome|IV Acetaminophen 1000 mg|IV Acetaminophen 1000 mg every 6 hours for 24 hours
580610|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
580611|NCT00564486|O2|Outcome|IV Acetaminophen 650 mg|mITT - IV Acetaminophen 650 mg
580612|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
580613|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|mITT - IV Acetaminophen 1 gm
580614|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
580615|NCT00564486|E4|Reported Event|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
580616|NCT00564486|E3|Reported Event|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
580617|NCT00564486|E2|Reported Event|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
580618|NCT00564486|E1|Reported Event|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
580630|NCT00564447|P6|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
580631|NCT00564447|P5|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
580632|NCT00564447|P4|Participant Flow|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
580633|NCT00564447|P3|Participant Flow|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
580634|NCT00564447|P2|Participant Flow|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
580635|NCT00564447|P1|Participant Flow|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
580636|NCT00564447|O8|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
580637|NCT00564447|O7|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
580638|NCT00564447|O6|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
580639|NCT00564447|O5|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
580640|NCT00564447|O4|Outcome|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
580641|NCT00564447|O3|Outcome|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
580642|NCT00564447|O2|Outcome|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
580643|NCT00564447|O1|Outcome|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
580644|NCT00564447|E8|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
580645|NCT00564447|E7|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
580646|NCT00564447|E6|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
580647|NCT00564447|E5|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
580648|NCT00564447|E4|Reported Event|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
580649|NCT00564447|E3|Reported Event|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
580650|NCT00564447|E2|Reported Event|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
580651|NCT00564447|E1|Reported Event|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
580652|NCT00564278|B3|Baseline|Total|Total of all reporting groups
580653|NCT00564278|B2|Baseline|Motivational Pharmacotherapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.
580654|NCT00564278|B1|Baseline|Standard Medication Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.
580655|NCT00564278|P2|Participant Flow|Motivational Antidepressant Therapy|As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
580656|NCT00564278|P1|Participant Flow|Standard Antidepressant Therapy|As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
580657|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580658|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580659|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580660|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580661|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580662|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580663|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580664|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580665|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580780|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580666|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580667|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580668|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
580669|NCT00564278|E2|Reported Event|Motivational Antidepressant Therapy|Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
580670|NCT00564278|E1|Reported Event|Standard Antidepressant Therapy|Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
580671|NCT00564265|B1|Baseline|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
580672|NCT00564265|P1|Participant Flow|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
580673|NCT00564265|O1|Outcome|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
580674|NCT00564265|E1|Reported Event|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
580675|NCT00564070|B3|Baseline|Total|Total of all reporting groups
580676|NCT00564070|B2|Baseline|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580677|NCT00564070|B1|Baseline|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580678|NCT00564070|P2|Participant Flow|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580679|NCT00564070|P1|Participant Flow|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580680|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580681|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580682|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580683|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580684|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580685|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580686|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580687|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580871|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
581608|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
580688|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580689|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580690|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580691|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580692|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580693|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580694|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580695|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580696|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580697|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580698|NCT00564070|O2|Outcome|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580699|NCT00564070|O1|Outcome|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580700|NCT00564070|E2|Reported Event|CBT-AD|"Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)~Enhanced treatment as usual plus CBT-AD: The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care."
580701|NCT00564070|E1|Reported Event|Enhanced Treatment as Usual|"Enhanced treatment as usual plus single-session life-steps treatment~Enhanced treatment as usual plus adherence training: The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management."
580702|NCT00563797|B3|Baseline|Total|Total of all reporting groups
580703|NCT00563797|B2|Baseline|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
580704|NCT00563797|B1|Baseline|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
580705|NCT00563797|P2|Participant Flow|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
580706|NCT00563797|P1|Participant Flow|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
580707|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
580708|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
580709|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
580710|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
580711|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
580712|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
580713|NCT00563797|O2|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
580714|NCT00563797|O1|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
580715|NCT00563797|E2|Reported Event|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to themedication capsules.~Placebo: Placebo pill"
580716|NCT00563797|E1|Reported Event|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
580717|NCT00563706|B10|Baseline|Total|Total of all reporting groups
580718|NCT00563706|B9|Baseline|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580719|NCT00563706|B8|Baseline|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580720|NCT00563706|B7|Baseline|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580721|NCT00563706|B6|Baseline|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580722|NCT00563706|B5|Baseline|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580723|NCT00563706|B4|Baseline|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580724|NCT00563706|B3|Baseline|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580725|NCT00563706|B2|Baseline|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580726|NCT00563706|B1|Baseline|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580727|NCT00563706|P9|Participant Flow|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580728|NCT00563706|P8|Participant Flow|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580729|NCT00563706|P7|Participant Flow|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580781|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
581510|NCT00561678|B1|Baseline|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
580730|NCT00563706|P6|Participant Flow|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580731|NCT00563706|P5|Participant Flow|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580732|NCT00563706|P4|Participant Flow|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580733|NCT00563706|P3|Participant Flow|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580734|NCT00563706|P2|Participant Flow|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580735|NCT00563706|P1|Participant Flow|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580736|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580737|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580738|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580739|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580740|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580741|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580742|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580743|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580744|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580745|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580746|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580747|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580748|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580749|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580750|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580751|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580752|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580753|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580754|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580755|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580756|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580757|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580758|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580759|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580760|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580761|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580762|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580763|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580764|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580765|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580766|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580767|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580768|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580769|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580770|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580771|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580772|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580773|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580774|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580775|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580776|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580777|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580778|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580779|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580969|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
580782|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580783|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580784|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580785|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580786|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580787|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580788|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580789|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580790|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580791|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580792|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580793|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580794|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580795|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580796|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580797|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580970|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
580798|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580799|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580800|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580801|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580802|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580803|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580804|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580805|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580806|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580807|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580808|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580809|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580810|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580811|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580812|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580813|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580870|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580814|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580815|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580816|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580817|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580818|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580819|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580820|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580821|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580822|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580823|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580824|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580825|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580826|NCT00563706|E9|Reported Event|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
580827|NCT00563706|E8|Reported Event|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580828|NCT00563706|E7|Reported Event|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
580829|NCT00563706|E6|Reported Event|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580830|NCT00563706|E5|Reported Event|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
580831|NCT00563706|E4|Reported Event|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580832|NCT00563706|E3|Reported Event|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580833|NCT00563706|E2|Reported Event|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580834|NCT00563706|E1|Reported Event|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
580835|NCT00563576|B3|Baseline|Total|Total of all reporting groups
580836|NCT00563576|B2|Baseline|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
580837|NCT00563576|B1|Baseline|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
580838|NCT00563576|P2|Participant Flow|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
580839|NCT00563576|P1|Participant Flow|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
580840|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
580841|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
580842|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
580843|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
580844|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
580845|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
580846|NCT00563576|E2|Reported Event|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
580847|NCT00563576|E1|Reported Event|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
580848|NCT00563381|B3|Baseline|Total|Total of all reporting groups
580849|NCT00563381|B2|Baseline|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580850|NCT00563381|B1|Baseline|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580851|NCT00563381|P2|Participant Flow|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580852|NCT00563381|P1|Participant Flow|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580853|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580854|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580855|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580856|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580857|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580858|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580859|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580860|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580861|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580862|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580863|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580864|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580865|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580866|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580867|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580868|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580869|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580872|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580873|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580874|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580875|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580876|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580877|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580878|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580879|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580880|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580881|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580882|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580883|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580884|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580885|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580886|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580887|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580888|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580889|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580890|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580891|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580892|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580893|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580894|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580895|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580896|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580897|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580898|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580899|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580900|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580901|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580902|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580903|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580904|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580905|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580906|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580907|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580908|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580909|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580910|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580911|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580912|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580913|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580914|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580915|NCT00563381|E2|Reported Event|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
580916|NCT00563381|E1|Reported Event|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
580917|NCT00563368|B8|Baseline|Total|Total of all reporting groups
580918|NCT00563368|B7|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
580919|NCT00563368|B6|Baseline|TPM 92 mg|92 mg topiramate
580920|NCT00563368|B5|Baseline|PHEN 15 mg|15 mg phentermine
580921|NCT00563368|B4|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
580922|NCT00563368|B3|Baseline|TPM 46 mg|46 mg topiramate
580923|NCT00563368|B2|Baseline|PHEN 7.5 mg|7.5 mg phentermine
580924|NCT00563368|B1|Baseline|Placebo|Placebo
580925|NCT00563368|P7|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
580926|NCT00563368|P6|Participant Flow|TPM 92 mg|92 mg topiramate
580927|NCT00563368|P5|Participant Flow|PHEN 15 mg|15 mg phentermine
580928|NCT00563368|P4|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
580929|NCT00563368|P3|Participant Flow|TPM 46 mg|46 mg topiramate
580930|NCT00563368|P2|Participant Flow|PHEN 7.5 mg|7.5 mg phentermine
580931|NCT00563368|P1|Participant Flow|Placebo|Placebo
580932|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
580933|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
580934|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
580935|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
580936|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
580937|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
580938|NCT00563368|O1|Outcome|Placebo|Placebo
580939|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
580940|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
580941|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
580942|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
580943|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
580944|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
580945|NCT00563368|O1|Outcome|Placebo|Placebo
580946|NCT00563368|E7|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
580947|NCT00563368|E6|Reported Event|TPM 92 mg|92 mg topiramate
580948|NCT00563368|E5|Reported Event|PHEN 15 mg|15 mg phentermine
580949|NCT00563368|E4|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
580950|NCT00563368|E3|Reported Event|TPM 46 mg|46 mg topiramate
580951|NCT00563368|E2|Reported Event|PHEN 7.5 mg|7.5 mg phentermine
580952|NCT00563368|E1|Reported Event|Placebo|Placebo
580953|NCT00563316|B1|Baseline|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
580954|NCT00563316|P1|Participant Flow|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
580955|NCT00563316|O5|Outcome|Treatment Phase 4|All Other – 72 hours after administration of irinotecan in Cycle 2 until end of study.
580956|NCT00563316|O4|Outcome|Treatment Phase 3|Cycle 2 Irinotecan and Panitumumab – After irinotecan administration until 72 hours after administration.
580957|NCT00563316|O3|Outcome|Treatment Phase 2|Cycle 1 Irinotecan and Panitumumab – After first panitumumab administration until the start of Cycle 2.
580958|NCT00563316|O2|Outcome|Treatment Phase 1|Cycle 1 Irinotecan – After irinotecan administration, but before panitumumab administration.
580959|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
580960|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
580961|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
580962|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
580963|NCT00563316|E1|Reported Event|Panitumumab With Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
580964|NCT00563290|B3|Baseline|Total|Total of all reporting groups
580965|NCT00563290|B2|Baseline|Arm II Dastinib|Patients receive oral dasatinib 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
580966|NCT00563290|B1|Baseline|Arm I Dasatinib|Patients receive oral dasatinib 100 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
580967|NCT00563290|P2|Participant Flow|Arm II Dasatinib|Patients receive 70 mg dasatinib PO BID on days 1-28
580968|NCT00563290|P1|Participant Flow|Arm I Dasatinib|Patients receive 100 mg orally twice a day.
581065|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
580971|NCT00563290|O1|Outcome|Arm I and Arm II|"For Arm I patients receive Dasatinib100 mg orally twice a day.~For Arm II patients receive Dasatinib 70 mg orally twice a day."
580972|NCT00563290|O2|Outcome|Arm II: Dasatinib|Patients receive 70 mg orally twice a day.
580973|NCT00563290|O1|Outcome|Arm I: Dasatinib|Patients receive 100 mg orally twice a day.
580974|NCT00563290|E2|Reported Event|Dasatinib 70 mg|Patients receive the initial dose of 70 mg orally twice a day. Dose was reduced to 70 mg orally based on toxicity.
580975|NCT00563290|E1|Reported Event|Dasatinib 100 mg|Patients receive the initial dose of 100 mg orally twice a day.
580976|NCT00562965|B3|Baseline|Total|Total of all reporting groups
580977|NCT00562965|B2|Baseline|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580978|NCT00562965|B1|Baseline|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580979|NCT00562965|P2|Participant Flow|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580980|NCT00562965|P1|Participant Flow|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580981|NCT00562965|O2|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580982|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580983|NCT00562965|O2|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580984|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580985|NCT00562965|O2|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580986|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580987|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580988|NCT00562965|O2|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
581015|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
580989|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580990|NCT00562965|O2|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580991|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580992|NCT00562965|O2|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580993|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580994|NCT00562965|O2|Outcome|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580995|NCT00562965|O1|Outcome|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580996|NCT00562965|E2|Reported Event|Control Regimens R-CVP + R-FND|Participants received either regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA along with intravenous infusion of cyclophosphamide 750 mg/m^2 of BSA and vincristine 1.4 mg/m^2 of BSA on Day 1 followed by oral prednisone/prednisolone 40 mg/m^2 of BSA on Days 1 through 5 for up to 8 cycles (R-CVP); or regimen containing intravenous infusion of rituximab 375 mg/m^2 of BSA on Day 1 followed by intravenous infusion of novantrone (mitoxantrone) 10 mg/m^2 of BSA on Day 2, intravenous infusion of fludarabine 25 mg/m^2 of BSA on Days 2 through 4, and oral dexamethasone 20 mg once daily on Days 1 through 5 for up to 8 cycles (R-FND). Each regimen cycle was of 21 days.
580997|NCT00562965|E1|Reported Event|Rituximab + Inotuzumab Ozogamicin|Participants received intravenous infusion of rituximab 375 milligram per square meter (mg/m^2) of body surface area (BSA) on Day 1 followed by intravenous infusion of inotuzumab ozogamicin (CMC-544) 1.8 mg/m^2 of BSA on Day 2 for each cycle up to 8 cycles. Each cycle was of 28 days.
580998|NCT00562861|B3|Baseline|Total|Total of all reporting groups
580999|NCT00562861|B2|Baseline|Mood Stabilizer Plus Placebo|Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers
581000|NCT00562861|B1|Baseline|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.
581001|NCT00562861|P2|Participant Flow|Mood Stabilizer Plus Placebo|Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
581002|NCT00562861|P1|Participant Flow|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d.
581003|NCT00562861|O2|Outcome|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
581004|NCT00562861|O1|Outcome|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
581005|NCT00562861|E2|Reported Event|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
581006|NCT00562861|E1|Reported Event|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
581007|NCT00562627|B4|Baseline|Total|Total of all reporting groups
581008|NCT00562627|B3|Baseline|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
581009|NCT00562627|B2|Baseline|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
581010|NCT00562627|B1|Baseline|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
581011|NCT00562627|P3|Participant Flow|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
581012|NCT00562627|P2|Participant Flow|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
581013|NCT00562627|P1|Participant Flow|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
581014|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
581016|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
581017|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
581018|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
581019|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
581020|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
581021|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
581022|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
581023|NCT00562627|E3|Reported Event|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
581024|NCT00562627|E2|Reported Event|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
581025|NCT00562627|E1|Reported Event|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
581026|NCT00562588|B3|Baseline|Total|Total of all reporting groups
581027|NCT00562588|B2|Baseline|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581028|NCT00562588|B1|Baseline|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581029|NCT00562588|P2|Participant Flow|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581030|NCT00562588|P1|Participant Flow|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581031|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581032|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581033|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581034|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581035|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581036|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581037|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581038|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581039|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581040|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581041|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581042|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581043|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581044|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581045|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581046|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581047|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581048|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581049|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581050|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581051|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581052|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581053|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581054|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581055|NCT00562588|E2|Reported Event|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581056|NCT00562588|E1|Reported Event|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
581057|NCT00562484|B3|Baseline|Total|Total of all reporting groups
581058|NCT00562484|B2|Baseline|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581059|NCT00562484|B1|Baseline|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581060|NCT00562484|P2|Participant Flow|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581061|NCT00562484|P1|Participant Flow|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581062|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581063|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581064|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581609|NCT00561600|E2|Reported Event|Pinnacle Acetabular Cup System|
581066|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581067|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581068|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581069|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581070|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581071|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581072|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581073|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581074|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581075|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581076|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581077|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581078|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581079|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581080|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581081|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581082|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581083|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581084|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581085|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581086|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581087|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581088|NCT00562484|E2|Reported Event|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
581089|NCT00562484|E1|Reported Event|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
581090|NCT00562354|B3|Baseline|Total|Total of all reporting groups
581091|NCT00562354|B2|Baseline|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581092|NCT00562354|B1|Baseline|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581093|NCT00562354|P2|Participant Flow|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581094|NCT00562354|P1|Participant Flow|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581095|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581096|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
581097|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581098|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581099|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
581100|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581101|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581102|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581103|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581104|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581105|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581106|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581107|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581108|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581109|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581511|NCT00561678|P2|Participant Flow|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581110|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581111|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581112|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581113|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581114|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581115|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581116|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581117|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581118|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581119|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581120|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581121|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581122|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581123|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581124|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581125|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581126|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581127|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581128|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581129|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
581130|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
581131|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
581132|NCT00562354|E2|Reported Event|13vPnC (≥65 Years of Age)|"13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=77; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=116. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
581133|NCT00562354|E1|Reported Event|13vPnC (50 to 64 Years of Age)|"13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=80; systematic (solicited) Local Reactions N=120; systematic (solicited) Systemic Events N=112. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
581134|NCT00562328|B1|Baseline|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
581135|NCT00562328|P1|Participant Flow|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
581136|NCT00562328|O1|Outcome|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
581137|NCT00562328|E1|Reported Event|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
581138|NCT00562315|B1|Baseline|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581139|NCT00562315|P1|Participant Flow|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581140|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581141|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581312|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581142|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581143|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|"This is a single arm study~[18F]FACBC: [18F]FACBC is given intravenously prior to PET scan"
581144|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581145|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581146|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581147|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581148|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581149|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581150|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581151|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
581152|NCT00562315|E1|Reported Event|FACBC PET-CT and ProstaScint CT|All participants who received scans, including repeat scans, were monitored for adverse events.
581153|NCT00562302|B3|Baseline|Total|Total of all reporting groups
581154|NCT00562302|B2|Baseline|Control Group|Control group with no intervention
581155|NCT00562302|B1|Baseline|Bio-Seal Group|Bio-Seal Plug Implanted
581156|NCT00562302|P2|Participant Flow|Control Group|Control group with no intervention
581157|NCT00562302|P1|Participant Flow|Bio-Seal Group|Bio-Seal Plug Implanted
581158|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581159|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581160|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581161|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581162|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581163|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581164|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581165|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581166|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581167|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581168|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581169|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581170|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581171|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581172|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
581173|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
581174|NCT00562302|E2|Reported Event|Control Group|Control group with no intervention
581175|NCT00562302|E1|Reported Event|Bio-Seal Group|Bio-Seal Plug Implanted
581176|NCT00562159|B3|Baseline|Total|Total of all reporting groups
581177|NCT00562159|B2|Baseline|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
581178|NCT00562159|B1|Baseline|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
581179|NCT00562159|P2|Participant Flow|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
581180|NCT00562159|P1|Participant Flow|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
581181|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
581182|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
581183|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
581184|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
581185|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
581186|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
581187|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
581188|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
581189|NCT00562159|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
581190|NCT00562159|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
581191|NCT00562120|B1|Baseline|Entire Study Population|All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).
581214|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581593|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581192|NCT00562120|P4|Participant Flow|Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
581193|NCT00562120|P3|Participant Flow|Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
581194|NCT00562120|P2|Participant Flow|PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
581195|NCT00562120|P1|Participant Flow|PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D|PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
581196|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581197|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581198|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581199|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581200|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581201|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581202|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581203|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581204|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581205|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581206|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581207|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581208|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581209|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581210|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581211|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581212|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581213|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581215|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581216|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581217|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581218|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581219|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581220|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581221|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581222|NCT00562120|E4|Reported Event|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581223|NCT00562120|E3|Reported Event|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581224|NCT00562120|E2|Reported Event|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581225|NCT00562120|E1|Reported Event|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
581226|NCT00562094|B1|Baseline|Pantoprazole|All patients enrolled
581227|NCT00562094|P1|Participant Flow|Pantoprazole|All patients enrolled
581228|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
581229|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
581230|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
581231|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
581232|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
581233|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
581234|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values ('as observed')
581235|NCT00562094|O2|Outcome|Pantoprazole / End of Therapy|All patients with valid values ('as observed')
581236|NCT00562094|O1|Outcome|Pantoprazole / Start of Therapy|All patients with valid values ('as observed')
581237|NCT00562094|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
581238|NCT00561977|B4|Baseline|Total|Total of all reporting groups
581239|NCT00561977|B3|Baseline|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581240|NCT00561977|B2|Baseline|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581241|NCT00561977|B1|Baseline|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581242|NCT00561977|P3|Participant Flow|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581243|NCT00561977|P2|Participant Flow|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581244|NCT00561977|P1|Participant Flow|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581245|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581246|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581247|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581248|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581249|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581250|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581251|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581252|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581253|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581254|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581255|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581256|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581257|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581258|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581259|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581260|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581261|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581262|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581263|NCT00561977|E3|Reported Event|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
581264|NCT00561977|E2|Reported Event|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
581265|NCT00561977|E1|Reported Event|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
581266|NCT00561951|B4|Baseline|Total|Total of all reporting groups
581267|NCT00561951|B3|Baseline|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581268|NCT00561951|B2|Baseline|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581269|NCT00561951|B1|Baseline|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581270|NCT00561951|P3|Participant Flow|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581271|NCT00561951|P2|Participant Flow|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581272|NCT00561951|P1|Participant Flow|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581273|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581274|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581275|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581276|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581277|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581278|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581279|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581280|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581281|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581282|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581283|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581284|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581285|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581286|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581287|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581288|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581289|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581290|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581291|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581292|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581293|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581294|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581295|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581296|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581297|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581298|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581299|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581300|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581301|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581302|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581303|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581304|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581305|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581306|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581307|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581308|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581309|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581310|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581311|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581594|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581313|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581314|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581315|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581316|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581317|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581318|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581319|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581320|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581321|NCT00561951|E3|Reported Event|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
581322|NCT00561951|E2|Reported Event|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
581323|NCT00561951|E1|Reported Event|Placebo|Subjects were treated with placebo once daily for 12 weeks.
581324|NCT00561925|B4|Baseline|Total|Total of all reporting groups
581325|NCT00561925|B3|Baseline|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
581326|NCT00561925|B2|Baseline|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
581327|NCT00561925|B1|Baseline|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
581328|NCT00561925|P5|Participant Flow|NVP IR to XR|
581329|NCT00561925|P4|Participant Flow|NVP XR|
581330|NCT00561925|P3|Participant Flow|NVP XR 400mg QD|Nevirapine extended release 400 mg given once daily
581331|NCT00561925|P2|Participant Flow|NVP IR 200mg BID|Nevirapine immediate release 200 mg given twice daily
581332|NCT00561925|P1|Participant Flow|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
581333|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously received nevirapine IR during the pre week 144
581334|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
581335|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
581336|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
581337|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
581338|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
581339|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
581340|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
581341|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
581342|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
581343|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
581344|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
581345|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
581346|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
581347|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
581348|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
581349|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
581350|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
581351|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
581352|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
581353|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
581354|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
581355|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
581356|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
581357|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
581358|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
581359|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
581360|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
581361|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
581362|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
581363|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
581364|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
581365|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
581366|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
581367|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
581368|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
581369|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
581370|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
581371|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
581372|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
581373|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
581374|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
581375|NCT00561925|E5|Reported Event|NVP XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
581376|NCT00561925|E4|Reported Event|NVP IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
581377|NCT00561925|E3|Reported Event|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
581378|NCT00561925|E2|Reported Event|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
581379|NCT00561925|E1|Reported Event|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
581380|NCT00561912|B1|Baseline|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
581381|NCT00561912|P1|Participant Flow|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
581382|NCT00561912|O1|Outcome|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
581383|NCT00561912|E1|Reported Event|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
581384|NCT00561834|B1|Baseline|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
581385|NCT00561834|P1|Participant Flow|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
581386|NCT00561834|O1|Outcome|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
581387|NCT00561834|E1|Reported Event|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
581388|NCT00561821|B5|Baseline|Total|Total of all reporting groups
581389|NCT00561821|B4|Baseline|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581390|NCT00561821|B3|Baseline|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581391|NCT00561821|B2|Baseline|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581392|NCT00561821|B1|Baseline|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581393|NCT00561821|P4|Participant Flow|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581394|NCT00561821|P3|Participant Flow|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581395|NCT00561821|P2|Participant Flow|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581396|NCT00561821|P1|Participant Flow|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581397|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581398|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581399|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581400|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581401|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581402|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581403|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581404|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581405|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581406|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581407|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581408|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581409|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581410|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581411|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581412|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581413|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581414|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581415|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581416|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581417|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581418|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581419|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581420|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581421|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581422|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581423|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581424|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581425|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581426|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581427|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581428|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581429|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581430|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581431|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581432|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581433|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581434|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581435|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581436|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581437|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581438|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581439|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581440|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581441|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581442|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581443|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581444|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581445|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581446|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581447|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581448|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581449|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581450|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581451|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581452|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581453|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581454|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581455|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581456|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581457|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581458|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581459|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581460|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581461|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581462|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581463|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581464|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581465|NCT00561821|E4|Reported Event|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
581466|NCT00561821|E3|Reported Event|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581467|NCT00561821|E2|Reported Event|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581468|NCT00561821|E1|Reported Event|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
581469|NCT00561795|B3|Baseline|Total|Total of all reporting groups
581470|NCT00561795|B2|Baseline|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581509|NCT00561678|B2|Baseline|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581471|NCT00561795|B1|Baseline|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581472|NCT00561795|P4|Participant Flow|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581473|NCT00561795|P3|Participant Flow|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581474|NCT00561795|P2|Participant Flow|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581475|NCT00561795|P1|Participant Flow|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581476|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581477|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581478|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581479|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581480|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581481|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581482|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581483|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581484|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581485|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581486|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581487|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581488|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581489|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581490|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581491|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581492|NCT00561795|E2|Reported Event|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
581493|NCT00561795|E1|Reported Event|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
581494|NCT00561730|B1|Baseline|Pantoprazole|All patients enrolled
581495|NCT00561730|P1|Participant Flow|Pantoprazole|All patients enrolled
581496|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
581497|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
581498|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
581499|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
581500|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
581501|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
581502|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
581503|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
581504|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
581505|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
581506|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
581507|NCT00561730|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
581508|NCT00561678|B3|Baseline|Total|Total of all reporting groups
581512|NCT00561678|P1|Participant Flow|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581513|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581514|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581515|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581516|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581517|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581518|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581519|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581520|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581521|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581522|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581523|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581524|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581525|NCT00561678|E2|Reported Event|Placebo|Placebo - normal saline 0.5/ug/kg/hr
581526|NCT00561678|E1|Reported Event|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
581527|NCT00561652|B3|Baseline|Total|Total of all reporting groups
581528|NCT00561652|B2|Baseline|Arm 2|Chiropractic treatment plus Education plus exercise
581529|NCT00561652|B1|Baseline|Arm 1|Education plus exercise
581530|NCT00561652|P2|Participant Flow|Arm 2|Chiropractic treatment plus education plus exercise
581531|NCT00561652|P1|Participant Flow|Arm 1|Education plus exercise
581532|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
581533|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
581534|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
581535|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
581536|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
581537|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
581538|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
581539|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
581540|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
581541|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
581542|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
581543|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
581544|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
581545|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
581546|NCT00561652|E2|Reported Event|Arm 2|Chiropractic treatment plus education plus exercise
581547|NCT00561652|E1|Reported Event|Arm 1|Education plus exercise
581548|NCT00561600|B3|Baseline|Total|Total of all reporting groups
581549|NCT00561600|B2|Baseline|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
581550|NCT00561600|B1|Baseline|ASR XL|ASR™-XL Acetabular Cup System
581551|NCT00561600|P2|Participant Flow|B Pinnacle™|Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
581552|NCT00561600|P1|Participant Flow|A ASR™-XL|ASR™-XL Modular Acetabular Cup System stem
581553|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581554|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581555|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581556|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581557|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581558|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581559|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581560|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581561|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581562|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581563|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581564|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581565|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581566|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581567|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581568|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581569|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581570|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581571|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581572|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581573|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581574|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581575|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581576|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581577|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581578|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581579|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581580|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581581|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581582|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581583|NCT00561600|O2|Outcome|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
581584|NCT00561600|O1|Outcome|ASR XL|ASR™-XL Acetabular Cup System
581585|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581586|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581587|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581588|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581589|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581590|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581591|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
581592|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
581610|NCT00561600|E1|Reported Event|ASR XL Acetabular Cup System|
581611|NCT00561574|B3|Baseline|Total|Total of all reporting groups
581612|NCT00561574|B2|Baseline|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581613|NCT00561574|B1|Baseline|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581614|NCT00561574|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581615|NCT00561574|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581616|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581617|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581618|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581619|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581620|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581621|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581622|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581623|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581624|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581625|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581626|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581627|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581628|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581629|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581630|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581631|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581632|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581633|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581634|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581635|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581636|NCT00561574|E2|Reported Event|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
581637|NCT00561574|E1|Reported Event|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
581638|NCT00561470|B3|Baseline|Total|Total of all reporting groups
581639|NCT00561470|B2|Baseline|Aflibercept/Folfiri|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
581640|NCT00561470|B1|Baseline|Placebo/Folfiri|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
581641|NCT00561470|P2|Participant Flow|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581642|NCT00561470|P1|Participant Flow|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581643|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
581644|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
581645|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581646|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581647|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581648|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581649|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581650|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581905|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581651|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581652|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581653|NCT00561470|E2|Reported Event|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581654|NCT00561470|E1|Reported Event|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
581655|NCT00561457|B1|Baseline|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
581656|NCT00561457|P1|Participant Flow|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
581657|NCT00561457|O1|Outcome|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
581658|NCT00561457|E1|Reported Event|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
581659|NCT00561431|B3|Baseline|Total|Total of all reporting groups
581660|NCT00561431|B2|Baseline|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
581661|NCT00561431|B1|Baseline|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
581662|NCT00561431|P2|Participant Flow|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
581663|NCT00561431|P1|Participant Flow|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
581664|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
581665|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
581666|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
581667|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
581668|NCT00561431|E2|Reported Event|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
581669|NCT00561431|E1|Reported Event|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
581670|NCT00561418|B1|Baseline|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
581671|NCT00561418|P1|Participant Flow|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post Hematopoietic Stem Cell Transplantation),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
581672|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
581673|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
581674|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
581721|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581906|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581675|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
581676|NCT00561418|E1|Reported Event|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
581677|NCT00561392|B1|Baseline|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581678|NCT00561392|P1|Participant Flow|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581679|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581680|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581681|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581682|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581683|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581684|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581685|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581686|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581687|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581688|NCT00561392|E1|Reported Event|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
581689|NCT00561353|B11|Baseline|Total|Total of all reporting groups
581690|NCT00561353|B10|Baseline|TMC435 200 mg (Cohort 5)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581691|NCT00561353|B9|Baseline|Placebo (Cohort 4)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581692|NCT00561353|B8|Baseline|TMC435 200 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581693|NCT00561353|B7|Baseline|TMC435 150 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581694|NCT00561353|B6|Baseline|TMC435 75 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581695|NCT00561353|B5|Baseline|Placebo (Cohort 2)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
582217|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
581696|NCT00561353|B4|Baseline|TMC435 200 mg (Cohort 2)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581697|NCT00561353|B3|Baseline|Placebo (Cohort 1)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581698|NCT00561353|B2|Baseline|TMC435 75mg (Cohort 1)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581699|NCT00561353|B1|Baseline|TMC435 25 mg (Cohort 1)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581700|NCT00561353|P10|Participant Flow|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581701|NCT00561353|P9|Participant Flow|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581702|NCT00561353|P8|Participant Flow|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581703|NCT00561353|P7|Participant Flow|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581704|NCT00561353|P6|Participant Flow|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581705|NCT00561353|P5|Participant Flow|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581706|NCT00561353|P4|Participant Flow|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581707|NCT00561353|P3|Participant Flow|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581708|NCT00561353|P2|Participant Flow|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581709|NCT00561353|P1|Participant Flow|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581710|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581711|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581712|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581713|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581714|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581715|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581716|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581717|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581718|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581719|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581720|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581907|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581722|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581723|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581724|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581725|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581726|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581727|NCT00561353|O3|Outcome|TTMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581728|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581729|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581730|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581731|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581732|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581733|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581734|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581735|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581736|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581737|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581738|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581739|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581740|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581741|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581742|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581743|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon (PegIFNα-2a) on Days 1, 8, 15, and 22.
581744|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581745|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581746|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581747|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581748|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581749|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581750|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581751|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581752|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581908|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581753|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581754|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581755|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581756|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581757|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581758|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581759|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581760|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers in Cohort 5, Panel D received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581761|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581762|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581763|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581764|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581765|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581766|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581767|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581768|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581769|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581770|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581771|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581772|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581773|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581774|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581775|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581830|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581776|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panels A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581777|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581778|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581779|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581780|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581781|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581782|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581783|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581784|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581785|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581786|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581787|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581788|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581789|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581790|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581791|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581792|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo identical in appearance toTMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581793|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581794|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581795|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581796|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581797|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581798|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581799|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581800|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581801|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581831|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581802|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581803|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581804|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
581805|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581806|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581807|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581808|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581809|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581810|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581811|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581812|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg and 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581813|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581814|NCT00561353|O1|Outcome|TMC435 25 (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581815|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581816|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581817|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581818|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581819|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581820|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581821|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581822|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581823|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581824|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581825|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581826|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581827|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581828|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581829|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581904|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
585610|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
581832|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581833|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581834|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581835|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581836|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581837|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581838|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581839|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581840|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581841|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581842|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581843|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581844|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
581845|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581846|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581847|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581848|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
581849|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
581850|NCT00561353|E11|Reported Event|All TMC435 (All Cohorts)|
581851|NCT00561353|E10|Reported Event|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581852|NCT00561353|E9|Reported Event|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581853|NCT00561353|E8|Reported Event|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581854|NCT00561353|E7|Reported Event|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581855|NCT00561353|E6|Reported Event|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
581856|NCT00561353|E5|Reported Event|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581857|NCT00561353|E4|Reported Event|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581858|NCT00561353|E3|Reported Event|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581859|NCT00561353|E2|Reported Event|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581860|NCT00561353|E1|Reported Event|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
581861|NCT00561340|B3|Baseline|Total|Total of all reporting groups
581862|NCT00561340|B2|Baseline|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
581863|NCT00561340|B1|Baseline|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
581864|NCT00561340|P2|Participant Flow|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
581865|NCT00561340|P1|Participant Flow|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
581866|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
581867|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
581868|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
581869|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
581870|NCT00561340|E2|Reported Event|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
581871|NCT00561340|E1|Reported Event|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
581872|NCT00561145|B3|Baseline|Total|Total of all reporting groups
581873|NCT00561145|B2|Baseline|Elderly Men|Elderly men: 65-85 years of age
581874|NCT00561145|B1|Baseline|Young Men|Young men: 20-40 years of age
581875|NCT00561145|P2|Participant Flow|Elderly Men|"Elderly men should be 65-85 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
581876|NCT00561145|P1|Participant Flow|Young Men|"Young men should be 20-40 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
581877|NCT00561145|O2|Outcome|Elderly Men|Elderly men: 65-85 years of age
581878|NCT00561145|O1|Outcome|Young Men|Young men: 20-40 years of age
581879|NCT00561145|E2|Reported Event|Elderly Men|Elderly men: 65-85 years of age
581880|NCT00561145|E1|Reported Event|Young Men|Young men: 20-40 years of age
581881|NCT00561080|B4|Baseline|Total|Total of all reporting groups
581882|NCT00561080|B3|Baseline|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581883|NCT00561080|B2|Baseline|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581884|NCT00561080|B1|Baseline|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581885|NCT00561080|P3|Participant Flow|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581886|NCT00561080|P2|Participant Flow|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581887|NCT00561080|P1|Participant Flow|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581888|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581889|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581890|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581891|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581892|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581893|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581894|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581895|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581896|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581897|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581898|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581899|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581900|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581901|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581902|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581903|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581909|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581910|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581911|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581912|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581913|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581914|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581915|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581916|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581917|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581918|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581919|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581920|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581921|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581922|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581923|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581924|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581925|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581926|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581927|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581928|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581929|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581930|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581931|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581932|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581933|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581934|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581935|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581936|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581937|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581938|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581939|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581940|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581941|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581942|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581943|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581944|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581945|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581946|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581947|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581948|NCT00561080|O3|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581949|NCT00561080|O2|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581950|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581951|NCT00561080|O1|Outcome|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581952|NCT00561080|O2|Outcome|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581953|NCT00561080|O1|Outcome|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581954|NCT00561080|E3|Reported Event|Group 3: Zostavax - Day 0 and Month 3|0.65 mL of Zostavax administered on Day 0 and Month 3
581955|NCT00561080|E2|Reported Event|Group 2: Zostavax - Day 0 and Month 1|0.65 mL of Zostavax administered on Day 0 and Month 1
581956|NCT00561080|E1|Reported Event|Group 1: Single Dose of Zostavax|Single injection of the 0.65 mL of Zostavax administered on Day 0
581957|NCT00561015|B7|Baseline|Total|Total of all reporting groups
581958|NCT00561015|B6|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582218|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
581959|NCT00561015|B5|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581960|NCT00561015|B4|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581961|NCT00561015|B3|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581962|NCT00561015|B2|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581963|NCT00561015|B1|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581964|NCT00561015|P6|Participant Flow|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581965|NCT00561015|P5|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581966|NCT00561015|P4|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581967|NCT00561015|P3|Participant Flow|Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581968|NCT00561015|P2|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581969|NCT00561015|P1|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581970|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582047|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
582219|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
581971|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581972|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581973|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581974|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581975|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581976|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581977|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581978|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581979|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581980|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581981|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581982|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582048|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
582049|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
581983|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581984|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581985|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581986|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581987|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581988|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581989|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581990|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581991|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581992|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581993|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581994|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582050|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
582051|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
581995|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581996|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
581997|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581998|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
581999|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582000|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582001|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582002|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582003|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582004|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582005|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582006|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582052|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
582053|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
582007|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582008|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582009|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582010|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582011|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582012|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582013|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582014|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582015|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582016|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582017|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582018|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582054|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
582220|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
582019|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582020|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582021|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582022|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582023|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582024|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582025|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582026|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 3|Participants who were never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582027|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582028|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582029|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582030|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582055|NCT00561002|E2|Reported Event|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
582221|NCT00560703|E2|Reported Event|Placebo|Sugar capsule, once per day for 84 days
582031|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582032|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582033|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582034|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582035|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582036|NCT00561015|E6|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582037|NCT00561015|E5|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582038|NCT00561015|E4|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582039|NCT00561015|E3|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582040|NCT00561015|E2|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
582041|NCT00561015|E1|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
582042|NCT00561002|B3|Baseline|Total|Total of all reporting groups
582043|NCT00561002|B2|Baseline|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
582044|NCT00561002|B1|Baseline|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
582045|NCT00561002|P2|Participant Flow|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
582046|NCT00561002|P1|Participant Flow|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
582056|NCT00561002|E1|Reported Event|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
582057|NCT00560950|B3|Baseline|Total|Total of all reporting groups
582058|NCT00560950|B2|Baseline|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
582059|NCT00560950|B1|Baseline|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
582060|NCT00560950|P2|Participant Flow|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
582061|NCT00560950|P1|Participant Flow|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
582062|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582063|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582064|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582065|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582066|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582067|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582068|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582069|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582070|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582071|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582072|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582073|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582074|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582075|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582076|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582077|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582078|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582079|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582080|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582081|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582082|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582083|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582084|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582085|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582086|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582087|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582088|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582089|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582090|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
582091|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
582092|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
582093|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
582094|NCT00560950|E2|Reported Event|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
582095|NCT00560950|E1|Reported Event|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
582096|NCT00560937|B3|Baseline|Total|Total of all reporting groups
582097|NCT00560937|B2|Baseline|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582098|NCT00560937|B1|Baseline|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582099|NCT00560937|P2|Participant Flow|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582100|NCT00560937|P1|Participant Flow|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582101|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582102|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582103|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582104|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582105|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582106|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582107|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582108|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582109|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582110|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582111|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582112|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582113|NCT00560937|E2|Reported Event|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
582143|NCT00560833|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582114|NCT00560937|E1|Reported Event|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
582115|NCT00560885|B1|Baseline|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
582116|NCT00560885|P1|Participant Flow|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
582117|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
582118|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
582119|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
582120|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
582121|NCT00560885|E1|Reported Event|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
582122|NCT00560859|B3|Baseline|Total|Total of all reporting groups
582123|NCT00560859|B2|Baseline|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
582124|NCT00560859|B1|Baseline|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
582125|NCT00560859|P2|Participant Flow|Watchful Waiting|"Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
582126|NCT00560859|P1|Participant Flow|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
582127|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
582128|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
582129|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
582130|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
582131|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
582132|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
582133|NCT00560859|E2|Reported Event|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
582134|NCT00560859|E1|Reported Event|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
582135|NCT00560833|B6|Baseline|Total|Total of all reporting groups
582136|NCT00560833|B5|Baseline|Esmertazapine 18 mg|Participants receive esmertazapine 18 mg, encapsulated tablet, PO, QD for up to 12 weeks
582137|NCT00560833|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582138|NCT00560833|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582139|NCT00560833|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582140|NCT00560833|B1|Baseline|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582141|NCT00560833|P5|Participant Flow|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
582142|NCT00560833|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582144|NCT00560833|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582145|NCT00560833|P1|Participant Flow|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582146|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
582147|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582148|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582149|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582150|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582151|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
582152|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582153|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582154|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582155|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582156|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
582157|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582158|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582159|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582160|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582161|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
582162|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582163|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582164|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582165|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582166|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
582167|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582168|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582169|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582170|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582171|NCT00560833|E5|Reported Event|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
582172|NCT00560833|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
582173|NCT00560833|E3|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
582174|NCT00560833|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
582175|NCT00560833|E1|Reported Event|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
582176|NCT00560794|B1|Baseline|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582177|NCT00560794|P1|Participant Flow|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582178|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
582179|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
582180|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
582181|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
582182|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
582183|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
582184|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
582185|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
582216|NCT00560703|P1|Participant Flow|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
582186|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582187|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582188|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582189|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582190|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582191|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582192|NCT00560794|E1|Reported Event|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
582193|NCT00560755|B1|Baseline|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582194|NCT00560755|P1|Participant Flow|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582195|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582196|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582197|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582198|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582199|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582200|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582201|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582202|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582203|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582204|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582205|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582206|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582207|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582208|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582209|NCT00560755|O1|Outcome|ProQuad®|Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
582210|NCT00560755|E2|Reported Event|ProQuad® Arm: Dose 1|Healthy infants (12 to 22 months of age) received ProQuad® Dose 1 on Day 1.
582211|NCT00560755|E1|Reported Event|ProQuad® Arm: Dose 2|Healthy infants (12 to 22 months of age) received ProQuad® Dose 2 on Day 28 to Day 42.
582212|NCT00560703|B3|Baseline|Total|Total of all reporting groups
582213|NCT00560703|B2|Baseline|Placebo|Sugar capsule, once per day for 84 days
582214|NCT00560703|B1|Baseline|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
582215|NCT00560703|P2|Participant Flow|Placebo|Sugar capsule, once per day for 84 days
585611|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
582222|NCT00560703|E1|Reported Event|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
582223|NCT00560612|B3|Baseline|Total|Total of all reporting groups
582224|NCT00560612|B2|Baseline|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
582225|NCT00560612|B1|Baseline|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
582226|NCT00560612|P2|Participant Flow|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
582227|NCT00560612|P1|Participant Flow|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
582228|NCT00560612|O2|Outcome|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
582229|NCT00560612|O1|Outcome|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
582230|NCT00560612|E2|Reported Event|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
582231|NCT00560612|E1|Reported Event|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
582232|NCT00560573|B1|Baseline|All Participants|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
582233|NCT00560573|P6|Participant Flow|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582234|NCT00560573|P5|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582235|NCT00560573|P4|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582236|NCT00560573|P3|Participant Flow|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582237|NCT00560573|P2|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582238|NCT00560573|P1|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582239|NCT00560573|O1|Outcome|Overall Participapnts|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
582240|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
582241|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
582242|NCT00560573|O6|Outcome|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582243|NCT00560573|O5|Outcome|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582244|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582245|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582246|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582247|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582248|NCT00560573|O1|Outcome|Overall Population With PR and CR|Participants with PR and CR who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants with PR and CR who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
582249|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582250|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582251|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
582252|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582253|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582254|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
582255|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582994|NCT00558792|E1|Reported Event|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
582256|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582257|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582258|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582259|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582260|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582261|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 (absence) and on Day 1 of each cycle (presence) thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582262|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582263|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582264|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582265|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582266|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582267|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582268|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582269|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582332|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582995|NCT00558753|B3|Baseline|Total|Total of all reporting groups
582270|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582271|NCT00560573|O1|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582272|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582273|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582274|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582275|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582276|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582277|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582278|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582279|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582280|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582281|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582282|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582283|NCT00560573|E6|Reported Event|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
582284|NCT00560573|E5|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582285|NCT00560573|E4|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
585612|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
582286|NCT00560573|E3|Reported Event|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582287|NCT00560573|E2|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582288|NCT00560573|E1|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
582289|NCT00560560|B3|Baseline|Total|Total of all reporting groups
582290|NCT00560560|B2|Baseline|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582291|NCT00560560|B1|Baseline|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582292|NCT00560560|P2|Participant Flow|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582293|NCT00560560|P1|Participant Flow|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582294|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582295|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582296|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582297|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582298|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582299|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582300|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582301|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582302|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582303|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582304|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582409|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582305|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582306|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582307|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582308|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582309|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582310|NCT00560560|E2|Reported Event|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582311|NCT00560560|E1|Reported Event|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
582312|NCT00560508|B3|Baseline|Total|Total of all reporting groups
582313|NCT00560508|B2|Baseline|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582314|NCT00560508|B1|Baseline|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582315|NCT00560508|P2|Participant Flow|Pramipexole Immediate Release Group (PPX IR)|Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582316|NCT00560508|P1|Participant Flow|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582317|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582318|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582319|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582320|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582321|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582322|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582323|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582324|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582325|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582326|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582327|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
582328|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open label period
582329|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582330|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582331|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582333|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582334|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582335|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582336|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582337|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582338|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582339|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582340|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582341|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582342|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582343|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582344|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582345|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582346|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582347|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582348|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582349|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582350|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582351|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582352|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582353|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582354|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582355|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582356|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582357|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582358|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582359|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582360|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582361|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582362|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582363|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582364|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582365|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582366|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582367|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582368|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582369|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582370|NCT00560508|E2|Reported Event|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
582371|NCT00560508|E1|Reported Event|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
582372|NCT00560417|B3|Baseline|Total|Total of all reporting groups
582373|NCT00560417|B2|Baseline|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582374|NCT00560417|B1|Baseline|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582375|NCT00560417|P2|Participant Flow|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582376|NCT00560417|P1|Participant Flow|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582377|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582378|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582379|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582380|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582381|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582382|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582383|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582384|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582385|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582386|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582387|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582388|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582389|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582390|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582391|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582392|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582393|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582394|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582395|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582396|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582397|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582398|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582399|NCT00560417|E2|Reported Event|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
582400|NCT00560417|E1|Reported Event|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
582401|NCT00560404|B3|Baseline|Total|Total of all reporting groups
582402|NCT00560404|B2|Baseline|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582403|NCT00560404|B1|Baseline|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582404|NCT00560404|P2|Participant Flow|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582405|NCT00560404|P1|Participant Flow|C.E.R.A.|Participants received RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A.]) with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582406|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582407|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582408|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582410|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582411|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582412|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582413|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582414|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582415|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582416|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582417|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582418|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582419|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582420|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582421|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582422|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582423|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582424|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582425|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582426|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582427|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582428|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582429|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582430|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582431|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582432|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582433|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582434|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582435|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582436|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582437|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582438|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582439|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582440|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582441|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582442|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582443|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582444|NCT00560404|E2|Reported Event|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
582445|NCT00560404|E1|Reported Event|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
582446|NCT00560391|B6|Baseline|Total|Total of all reporting groups
582447|NCT00560391|B5|Baseline|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose –finding phase and 13 participants treated in dose expansion phase.
582448|NCT00560391|B4|Baseline|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582449|NCT00560391|B3|Baseline|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582450|NCT00560391|B2|Baseline|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582451|NCT00560391|B1|Baseline|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582452|NCT00560391|P5|Participant Flow|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582453|NCT00560391|P4|Participant Flow|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582454|NCT00560391|P3|Participant Flow|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582455|NCT00560391|P2|Participant Flow|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582456|NCT00560391|P1|Participant Flow|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582457|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582458|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582459|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582460|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582461|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582462|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582463|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582464|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582465|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582466|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582467|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582468|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582469|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582470|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582471|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582472|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582473|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582474|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582475|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582476|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582477|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582478|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582479|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582480|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582481|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582482|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582483|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582484|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582485|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582486|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
585613|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
582487|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582488|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582489|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582490|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582491|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582492|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582493|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582494|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582495|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582496|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582497|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582498|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582499|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582500|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582501|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582502|NCT00560391|O1|Outcome|All Treated Participants|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
582503|NCT00560391|E5|Reported Event|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582504|NCT00560391|E4|Reported Event|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582505|NCT00560391|E3|Reported Event|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
582506|NCT00560391|E2|Reported Event|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
583051|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
582507|NCT00560391|E1|Reported Event|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
582508|NCT00560352|B4|Baseline|Total|Total of all reporting groups
582509|NCT00560352|B3|Baseline|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582510|NCT00560352|B2|Baseline|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582511|NCT00560352|B1|Baseline|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582512|NCT00560352|P3|Participant Flow|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582513|NCT00560352|P2|Participant Flow|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582514|NCT00560352|P1|Participant Flow|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582515|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
582516|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582517|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582556|NCT00560235|B2|Baseline|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582557|NCT00560235|B1|Baseline|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582518|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582519|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
582520|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582521|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582522|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582523|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582524|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582525|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582526|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, once daily (QD) or twice daily (BID), depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
582527|NCT00560352|E3|Reported Event|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582558|NCT00560235|P3|Participant Flow|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
585614|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
582528|NCT00560352|E2|Reported Event|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582529|NCT00560352|E1|Reported Event|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
582530|NCT00560313|B1|Baseline|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
582531|NCT00560313|P1|Participant Flow|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
582532|NCT00560313|O4|Outcome|Men ACWY-CRM (One Dose)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post one dose of Men ACWY vaccine.
582533|NCT00560313|O3|Outcome|4CMenB (Post Dose 3)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 3.
582534|NCT00560313|O2|Outcome|4CMenB (Post Dose 2)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 2.
582535|NCT00560313|O1|Outcome|4CMenB (Post Dose 1)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 1
582536|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582537|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582538|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582539|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582540|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582541|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582542|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582543|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
582544|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254) strain.
582545|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99) strain
582546|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
582547|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
582548|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
582549|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
582550|NCT00560313|E4|Reported Event|Men ACWY-CRM|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1 MenACWY."
582551|NCT00560313|E3|Reported Event|4CMenB (3rd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 3."
582552|NCT00560313|E2|Reported Event|4CMenB (2nd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 2."
582553|NCT00560313|E1|Reported Event|4CMenB (1st Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1."
582554|NCT00560235|B4|Baseline|Total|Total of all reporting groups
582555|NCT00560235|B3|Baseline|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582559|NCT00560235|P2|Participant Flow|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582560|NCT00560235|P1|Participant Flow|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582561|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582562|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
582563|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
582564|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
582565|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582566|NCT00560235|O2|Outcome|Figitumumab 30 mg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
582567|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
582568|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582569|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582570|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
582571|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582572|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582573|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
582574|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582575|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582576|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
582577|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582578|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582579|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
582580|NCT00560235|E8|Reported Event|Figitumumab 30 mg/kg + Rapamycin (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
582581|NCT00560235|E7|Reported Event|Figitumumab 30mg/kg (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.
582582|NCT00560235|E6|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
582583|NCT00560235|E5|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
582584|NCT00560235|E4|Reported Event|Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
582585|NCT00560235|E3|Reported Event|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582586|NCT00560235|E2|Reported Event|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
582587|NCT00560235|E1|Reported Event|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
582588|NCT00560105|B3|Baseline|Total|Total of all reporting groups
582589|NCT00560105|B2|Baseline|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582637|NCT00559988|B2|Baseline|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582773|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582590|NCT00560105|B1|Baseline|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582591|NCT00560105|P2|Participant Flow|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582592|NCT00560105|P1|Participant Flow|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582593|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582594|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582595|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582596|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582597|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582598|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582599|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582704|NCT00559936|P1|Participant Flow|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
582705|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
582600|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582601|NCT00560105|E2|Reported Event|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582602|NCT00560105|E1|Reported Event|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
582603|NCT00560066|B3|Baseline|Total|Total of all reporting groups
582604|NCT00560066|B2|Baseline|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
582605|NCT00560066|B1|Baseline|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
582606|NCT00560066|P2|Participant Flow|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.
582607|NCT00560066|P1|Participant Flow|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.
582608|NCT00560066|O2|Outcome|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
582609|NCT00560066|O1|Outcome|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
582610|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
582611|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
582612|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
582613|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
582614|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
582615|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
582616|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
582617|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
582618|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
582619|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
582620|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
582621|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
582622|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
582623|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
582624|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
582625|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
582626|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
582627|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
582628|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
582629|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
582630|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
582631|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
582632|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
582633|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine
582634|NCT00560066|E2|Reported Event|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
582635|NCT00560066|E1|Reported Event|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
582636|NCT00559988|B3|Baseline|Total|Total of all reporting groups
582706|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
582638|NCT00559988|B1|Baseline|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582639|NCT00559988|P2|Participant Flow|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582640|NCT00559988|P1|Participant Flow|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582641|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582642|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582643|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582644|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582645|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582646|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582647|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582648|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582649|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582650|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582651|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582652|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582653|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582654|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582655|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582656|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582657|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582707|NCT00559936|E1|Reported Event|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
582833|NCT00559364|B3|Baseline|Total|Total of all reporting groups
583052|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
582658|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582659|NCT00559988|E2|Reported Event|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
582660|NCT00559988|E1|Reported Event|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
582661|NCT00559962|B9|Baseline|Total|Total of all reporting groups
582662|NCT00559962|B8|Baseline|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
582663|NCT00559962|B7|Baseline|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
582664|NCT00559962|B6|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
582665|NCT00559962|B5|Baseline|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
582666|NCT00559962|B4|Baseline|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
582667|NCT00559962|B3|Baseline|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
582668|NCT00559962|B2|Baseline|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
582669|NCT00559962|B1|Baseline|Placebo|Oral placebo every 4 weeks for 12 weeks
582670|NCT00559962|P8|Participant Flow|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
582671|NCT00559962|P7|Participant Flow|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
582672|NCT00559962|P6|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
582673|NCT00559962|P5|Participant Flow|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
582674|NCT00559962|P4|Participant Flow|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
582675|NCT00559962|P3|Participant Flow|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
582676|NCT00559962|P2|Participant Flow|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
582677|NCT00559962|P1|Participant Flow|Placebo|Oral placebo every 4 weeks for 12 weeks
582678|NCT00559962|O8|Outcome|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
582679|NCT00559962|O7|Outcome|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
582680|NCT00559962|O6|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
582681|NCT00559962|O5|Outcome|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
582682|NCT00559962|O4|Outcome|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
582683|NCT00559962|O3|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
582684|NCT00559962|O2|Outcome|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
582685|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
582686|NCT00559962|O2|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
582687|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
582688|NCT00559962|E8|Reported Event|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
582689|NCT00559962|E7|Reported Event|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
582690|NCT00559962|E6|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
582691|NCT00559962|E5|Reported Event|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
582692|NCT00559962|E4|Reported Event|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
582693|NCT00559962|E3|Reported Event|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
582694|NCT00559962|E2|Reported Event|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
582695|NCT00559962|E1|Reported Event|Placebo|Oral placebo every 4 weeks for 12 weeks
582696|NCT00559949|B1|Baseline|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
582697|NCT00559949|P1|Participant Flow|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
582698|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
582699|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
582700|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
582701|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
582702|NCT00559949|E1|Reported Event|All Participants|All participants on study.
582703|NCT00559936|B1|Baseline|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
582708|NCT00559897|B1|Baseline|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
582709|NCT00559897|P1|Participant Flow|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
582710|NCT00559897|O1|Outcome|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
582711|NCT00559897|E1|Reported Event|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
582712|NCT00559845|B1|Baseline|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582713|NCT00559845|P1|Participant Flow|Bevacizumab|"5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 milligrams per meter squared (mg/m^2) intravenous (i.v.) bolus over ≤15 minutes (min); epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles."
582714|NCT00559845|O1|Outcome|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582715|NCT00559845|O1|Outcome|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582716|NCT00559845|O1|Outcome|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582717|NCT00559845|O1|Outcome|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582718|NCT00559845|O1|Outcome|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582719|NCT00559845|O1|Outcome|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582739|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582720|NCT00559845|E1|Reported Event|Bevacizumab|"FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.~FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over ≤15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.~Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.~Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles."
582721|NCT00559754|B1|Baseline|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582722|NCT00559754|P1|Participant Flow|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|"Participants received doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.~Participants then received bevacizumab 15 mg per kilogram (mg/kg) IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles."
582723|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582724|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582725|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582726|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582727|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582728|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582729|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582730|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582731|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582732|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582733|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582734|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582735|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582736|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582737|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582738|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
583053|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
582740|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582741|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582742|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582743|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582744|NCT00559754|E1|Reported Event|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
582745|NCT00559637|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582746|NCT00559637|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582747|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582748|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582749|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582750|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582751|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582752|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582753|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582754|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582755|NCT00559637|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
582756|NCT00559585|B3|Baseline|Total|Total of all reporting groups
582757|NCT00559585|B2|Baseline|Intravenous (IV) Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
582859|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582758|NCT00559585|B1|Baseline|Subcutaneous (SC) Abatacept|Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
582759|NCT00559585|P2|Participant Flow|Intravenous (IV) Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
582760|NCT00559585|P1|Participant Flow|Subcutaneous (SC) Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. During the Open Label Long Term (LT) Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
582761|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582762|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582763|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582764|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582765|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582766|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582767|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582768|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582769|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582770|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582771|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582772|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
582860|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582774|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582775|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582776|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582777|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582778|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582779|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582780|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582781|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582782|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582783|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582784|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582785|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582786|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582787|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582788|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582789|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582790|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
583054|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
582791|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582792|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582793|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582794|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582795|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582796|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582797|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582798|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582799|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582800|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582801|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582802|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582803|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582804|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
582805|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582806|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception
582807|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
582808|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
582809|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (Subcutaneous placebo placebo).
582861|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
585615|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
582810|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582811|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582812|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582813|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582814|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582815|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
582816|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
582817|NCT00559585|E2|Reported Event|SC Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could continue SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
582818|NCT00559585|E1|Reported Event|IV Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could switch to SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
582819|NCT00559507|B1|Baseline|Treatment (Saracatinib)|Patients will receive AZD0530 175mg orally daily for 4 weeks.
582820|NCT00559507|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
582821|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
582822|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
582823|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
582824|NCT00559507|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
582825|NCT00559377|B1|Baseline|All Patients|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later.
582826|NCT00559377|P1|Participant Flow|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
582827|NCT00559377|O1|Outcome|Patients Who Had Response Determined by Clinical RECIST|
582828|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
582829|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
582830|NCT00559377|O1|Outcome|Disease-Free Survival|Patients who have remained disease-free throughout the 2 year follow up
582831|NCT00559377|O1|Outcome|2 Year Overall Survival|Patients who have not been declared deceased for 2 years after their last FMISO scan.
582832|NCT00559377|E1|Reported Event|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
582834|NCT00559364|B2|Baseline|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582835|NCT00559364|B1|Baseline|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582836|NCT00559364|P2|Participant Flow|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582837|NCT00559364|P1|Participant Flow|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582838|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582839|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582840|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582841|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582842|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582843|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582844|NCT00559364|E2|Reported Event|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582845|NCT00559364|E1|Reported Event|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
582846|NCT00559273|B3|Baseline|Total|Total of all reporting groups
582847|NCT00559273|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582848|NCT00559273|B1|Baseline|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582849|NCT00559273|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582850|NCT00559273|P1|Participant Flow|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
582851|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582852|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582853|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582854|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582855|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582856|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582857|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582858|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582862|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582863|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582864|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582865|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582866|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582867|NCT00559273|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
582868|NCT00559273|E1|Reported Event|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
582869|NCT00559104|B3|Baseline|Total|Total of all reporting groups
582870|NCT00559104|B2|Baseline|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
582871|NCT00559104|B1|Baseline|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
582872|NCT00559104|P2|Participant Flow|nonTBI-based Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
582873|NCT00559104|P1|Participant Flow|TBI-based Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
582874|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
582875|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
582876|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
582877|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
582878|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
582879|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
582880|NCT00559104|E2|Reported Event|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
582881|NCT00559104|E1|Reported Event|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
582882|NCT00559013|B1|Baseline|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
582883|NCT00559013|P1|Participant Flow|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
582884|NCT00559013|O1|Outcome|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
582885|NCT00559013|E1|Reported Event|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
582886|NCT00558896|B8|Baseline|Total|Total of all reporting groups
582887|NCT00558896|B7|Baseline|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582888|NCT00558896|B6|Baseline|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582889|NCT00558896|B5|Baseline|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582993|NCT00558792|E2|Reported Event|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
582890|NCT00558896|B4|Baseline|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582891|NCT00558896|B3|Baseline|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582892|NCT00558896|B2|Baseline|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582893|NCT00558896|B1|Baseline|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582894|NCT00558896|P7|Participant Flow|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582895|NCT00558896|P6|Participant Flow|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582896|NCT00558896|P5|Participant Flow|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582897|NCT00558896|P4|Participant Flow|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582898|NCT00558896|P3|Participant Flow|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582899|NCT00558896|P2|Participant Flow|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582900|NCT00558896|P1|Participant Flow|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582901|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582902|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582903|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582904|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582905|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582906|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582907|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582908|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582909|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582910|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582911|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582912|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582913|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582914|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582915|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582916|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582917|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582918|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582919|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582920|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582921|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582922|NCT00558896|E7|Reported Event|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582923|NCT00558896|E6|Reported Event|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582924|NCT00558896|E5|Reported Event|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582925|NCT00558896|E4|Reported Event|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582926|NCT00558896|E3|Reported Event|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582927|NCT00558896|E2|Reported Event|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582928|NCT00558896|E1|Reported Event|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
582929|NCT00558870|B3|Baseline|Total|Total of all reporting groups
582930|NCT00558870|B2|Baseline|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
582931|NCT00558870|B1|Baseline|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
582932|NCT00558870|P2|Participant Flow|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
582933|NCT00558870|P1|Participant Flow|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
582934|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
582935|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
582936|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
582937|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
582938|NCT00558870|E2|Reported Event|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
582939|NCT00558870|E1|Reported Event|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
582940|NCT00558831|B1|Baseline|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
582941|NCT00558831|P1|Participant Flow|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
582942|NCT00558831|O2|Outcome|Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion|
582943|NCT00558831|O1|Outcome|Benzoyl Peroxide 2.5% Cream|
582944|NCT00558831|E2|Reported Event|Benzoyl Peroxide 2.5% Plus Moisturizing Lotion|
582945|NCT00558831|E1|Reported Event|Benzoyl Peroxide 2.5%|
582946|NCT00558792|B4|Baseline|Total|Total of all reporting groups
582947|NCT00558792|B3|Baseline|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
582948|NCT00558792|B2|Baseline|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
582949|NCT00558792|B1|Baseline|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
582950|NCT00558792|P3|Participant Flow|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
582951|NCT00558792|P2|Participant Flow|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
582952|NCT00558792|P1|Participant Flow|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
582953|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582954|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582955|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582956|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582957|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582958|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582959|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582960|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582961|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582962|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582963|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582964|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582965|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582966|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582967|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582968|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582969|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582970|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582971|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582972|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582973|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582974|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582975|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582976|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582977|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582978|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582979|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582980|NCT00558792|O3|Outcome|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
582981|NCT00558792|O2|Outcome|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
582982|NCT00558792|O1|Outcome|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
582983|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582984|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582985|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582986|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582987|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582988|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582989|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582990|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
582991|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
582992|NCT00558792|E3|Reported Event|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
582996|NCT00558753|B2|Baseline|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
582997|NCT00558753|B1|Baseline|1 Placebo|Half of the patients will receive PO placebo for 14 days
582998|NCT00558753|P2|Participant Flow|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
582999|NCT00558753|P1|Participant Flow|1 Placebo|Half of the patients will receive oral (PO) placebo for 14 days
583000|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
583001|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
583002|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
583003|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
583004|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
583005|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
583006|NCT00558753|E2|Reported Event|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
583007|NCT00558753|E1|Reported Event|1 Placebo|Half of the patients will receive PO placebo for 14 days
583008|NCT00558701|B3|Baseline|Total|Total of all reporting groups
583009|NCT00558701|B2|Baseline|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583010|NCT00558701|B1|Baseline|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing.~Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583011|NCT00558701|P2|Participant Flow|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583012|NCT00558701|P1|Participant Flow|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583013|NCT00558701|O2|Outcome|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583014|NCT00558701|O1|Outcome|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583015|NCT00558701|E2|Reported Event|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583016|NCT00558701|E1|Reported Event|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
583017|NCT00558636|B3|Baseline|Total|Total of all reporting groups
583018|NCT00558636|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583019|NCT00558636|B1|Baseline|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583020|NCT00558636|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583021|NCT00558636|P1|Participant Flow|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583055|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583022|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583023|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583024|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583025|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583026|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583027|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583028|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583029|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583030|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583031|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583032|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583033|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583034|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583035|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583036|NCT00558636|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
583037|NCT00558636|E1|Reported Event|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
583038|NCT00558571|B5|Baseline|Total|Total of all reporting groups
583039|NCT00558571|B4|Baseline|100mg Empagliflozin|oral administration in the fasted state once daily.
583040|NCT00558571|B3|Baseline|25mg Empagliflozin|oral administration in the fasted state once daily.
583041|NCT00558571|B2|Baseline|10mg Empagliflozin|oral administration in the fasted state once daily.
583042|NCT00558571|B1|Baseline|Placebo|oral administration in the fasted state once daily.
583043|NCT00558571|P4|Participant Flow|100mg Empagliflozin|Oral administration in the fasted state once daily.
583044|NCT00558571|P3|Participant Flow|25mg Empagliflozin|Oral administration in the fasted state once daily.
583045|NCT00558571|P2|Participant Flow|10mg Empagliflozin|Oral administration in the fasted state once daily.
583046|NCT00558571|P1|Participant Flow|Placebo|Oral administration in the fasted state once daily
583047|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily
583048|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily
583049|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily
583050|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily
583056|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583057|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583058|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
583059|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583060|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583061|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583062|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
583063|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
583064|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
583065|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
583066|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
583067|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583068|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583069|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583070|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
583071|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583072|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583073|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583074|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
583075|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583076|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583077|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583078|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
583079|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
583080|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
583081|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
583082|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
583083|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583084|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583085|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583086|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
583087|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583088|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583089|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583090|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583091|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583092|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583093|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583094|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583095|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583096|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583097|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583098|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583099|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583100|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583101|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583102|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583103|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583104|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583105|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
583106|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
583107|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
583108|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
583109|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
583110|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
583111|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
583112|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
583113|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
583114|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
583115|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
583116|NCT00558571|E4|Reported Event|100mg Empagliflozin|oral administration in the fasted state once daily
583117|NCT00558571|E3|Reported Event|25mg Empagliflozin|oral administration in the fasted state once daily
583118|NCT00558571|E2|Reported Event|10mg Empagliflozin|oral administration in the fasted state once daily
583119|NCT00558571|E1|Reported Event|Placebo|oral administration in the fasted state once daily
583120|NCT00558558|B1|Baseline|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
583121|NCT00558558|P1|Participant Flow|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
583122|NCT00558558|O1|Outcome|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
583123|NCT00558558|E1|Reported Event|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
583124|NCT00558467|B3|Baseline|Total|Total of all reporting groups
583125|NCT00558467|B2|Baseline|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583126|NCT00558467|B1|Baseline|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583127|NCT00558467|P2|Participant Flow|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583128|NCT00558467|P1|Participant Flow|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583129|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583130|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583131|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583132|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583133|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583134|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583135|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583136|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583137|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583138|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583139|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583140|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583141|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583142|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583143|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583144|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583145|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583146|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583147|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583148|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583149|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583150|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583151|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583152|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583153|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583154|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583155|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583156|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583157|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583158|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583159|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583160|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583161|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583162|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583163|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583164|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583165|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583166|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583167|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583168|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583169|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583170|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583171|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583172|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583173|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583174|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583175|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583176|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583177|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583178|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583179|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
583180|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583181|NCT00558467|E2|Reported Event|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
585616|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
583182|NCT00558467|E1|Reported Event|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
583183|NCT00558428|B5|Baseline|Total|Total of all reporting groups
583184|NCT00558428|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg|
583185|NCT00558428|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg|
583186|NCT00558428|B2|Baseline|Amlodipine 10mg|
583187|NCT00558428|B1|Baseline|Amlodipine 5mg|
583188|NCT00558428|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
583189|NCT00558428|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
583190|NCT00558428|P2|Participant Flow|Amlodipine 10mg|
583191|NCT00558428|P1|Participant Flow|Amlodipine 5mg|
583192|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583193|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583194|NCT00558428|O2|Outcome|Amlodipine 10mg|
583195|NCT00558428|O1|Outcome|Amlodipine 5mg|
583196|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583197|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583198|NCT00558428|O2|Outcome|Amlodipine 10mg|
583199|NCT00558428|O1|Outcome|Amlodipine 5mg|
583200|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583201|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583202|NCT00558428|O2|Outcome|Amlodipine 10mg|
583203|NCT00558428|O1|Outcome|Amlodipine 5mg|
583204|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583205|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583206|NCT00558428|O2|Outcome|Amlodipine 10mg|
583207|NCT00558428|O1|Outcome|Amlodipine 5mg|
583208|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583209|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583210|NCT00558428|O2|Outcome|Amlodipine 10mg|
583211|NCT00558428|O1|Outcome|Amlodipine 5mg|
583212|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583213|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583214|NCT00558428|O2|Outcome|Amlodipine 10mg|
583215|NCT00558428|O1|Outcome|Amlodipine 5mg|
583216|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583217|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583218|NCT00558428|O2|Outcome|Amlodipine 10mg|
583219|NCT00558428|O1|Outcome|Amlodipine 5mg|
583220|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
583221|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
583222|NCT00558428|O2|Outcome|Amlodipine 10mg|
583223|NCT00558428|O1|Outcome|Amlodipine 5mg|
583224|NCT00558428|E4|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
583225|NCT00558428|E3|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
583226|NCT00558428|E2|Reported Event|Amlodipine 10mg|
583227|NCT00558428|E1|Reported Event|Amlodipine 5mg|
583228|NCT00558363|B3|Baseline|Total|Total of all reporting groups
583229|NCT00558363|B2|Baseline|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583230|NCT00558363|B1|Baseline|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583231|NCT00558363|P2|Participant Flow|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583232|NCT00558363|P1|Participant Flow|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583233|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583234|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583235|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583236|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583237|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583238|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583239|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583240|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583241|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583242|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583243|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583244|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583245|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583246|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583247|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583248|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583249|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583250|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583251|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583252|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583253|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583254|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583255|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583256|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583257|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583258|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583259|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583260|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583261|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583262|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583263|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583264|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583265|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583266|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583267|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583268|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583269|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583270|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583271|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583272|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583273|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583274|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583275|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583276|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583277|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583278|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583279|NCT00558363|E2|Reported Event|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
583280|NCT00558363|E1|Reported Event|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
583281|NCT00558285|B6|Baseline|Total|Total of all reporting groups
583282|NCT00558285|B5|Baseline|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583283|NCT00558285|B4|Baseline|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583284|NCT00558285|B3|Baseline|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583285|NCT00558285|B2|Baseline|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583286|NCT00558285|B1|Baseline|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583287|NCT00558285|P5|Participant Flow|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583288|NCT00558285|P4|Participant Flow|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583289|NCT00558285|P3|Participant Flow|Indacaterol/Glycopyrrolate 150 μg/100 μg|"One capsule indacaterol/glycopyrrolate 150 μg/50 μg and one capsule 50μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583290|NCT00558285|P2|Participant Flow|Indacaterol/Glycopyrrolate 300 μg/100 μg|"One capsule indacaterol/glycopyrrolate 300 μg/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583291|NCT00558285|P1|Participant Flow|Indacaterol/Glycopyrrolate 600 μg/100 μg|"Two capsules indacaterol/glycopyrrolate 300 μg/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583292|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583293|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583294|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583295|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583371|NCT00558272|E2|Reported Event|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583296|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583297|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583298|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583299|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583300|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583301|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583302|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583303|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583304|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583305|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583306|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583307|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583308|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583309|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583310|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583311|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583312|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583313|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583314|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583315|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583316|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583317|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583318|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583319|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583320|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583321|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583322|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583323|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583324|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583325|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583326|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583327|NCT00558285|E5|Reported Event|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol /albuterol as rescue medication was permitted throughout the study."
583328|NCT00558285|E4|Reported Event|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583329|NCT00558285|E3|Reported Event|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583330|NCT00558285|E2|Reported Event|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583331|NCT00558285|E1|Reported Event|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
583332|NCT00558272|B3|Baseline|Total|Total of all reporting groups
583333|NCT00558272|B2|Baseline|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583334|NCT00558272|B1|Baseline|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583335|NCT00558272|P2|Participant Flow|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583336|NCT00558272|P1|Participant Flow|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583337|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583338|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583339|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583340|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583341|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583342|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583343|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583344|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583345|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583346|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583347|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583348|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583349|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583350|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583351|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583352|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583353|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583354|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583355|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583356|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583357|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583358|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583359|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583360|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583361|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583362|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583363|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583364|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583365|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583366|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583367|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583368|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583369|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
583370|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583372|NCT00558272|E1|Reported Event|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
583373|NCT00558259|B3|Baseline|Total|Total of all reporting groups
583374|NCT00558259|B2|Baseline|Placebo|Matching placebo
583375|NCT00558259|B1|Baseline|Dabigatran|Dabigatran 150mg bid
583376|NCT00558259|P2|Participant Flow|Placebo|Matching placebo
583377|NCT00558259|P1|Participant Flow|Dabigatran|Dabigatran 150mg bid (twice daily)
583378|NCT00558259|O2|Outcome|Placebo|Matching placebo
583379|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583380|NCT00558259|O2|Outcome|Placebo|Matching placebo
583381|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583382|NCT00558259|O2|Outcome|Placebo|Matching placebo
583383|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583384|NCT00558259|O2|Outcome|Placebo|Matching placebo
583385|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583386|NCT00558259|O2|Outcome|Placebo|Matching placebo
583387|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583388|NCT00558259|O2|Outcome|Placebo|Matching placebo
583389|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583390|NCT00558259|O2|Outcome|Placebo|Matching placebo
583391|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583392|NCT00558259|O2|Outcome|Placebo|Matching placebo
583393|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
583394|NCT00558259|E2|Reported Event|Placebo|Matching placebo
583395|NCT00558259|E1|Reported Event|Dabigatran|Dabigatran 150mg bid
583396|NCT00558246|B1|Baseline|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
583397|NCT00558246|P1|Participant Flow|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
583398|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583399|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583400|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583401|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583402|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583403|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583404|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583405|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583406|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583407|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583408|NCT00558246|E3|Reported Event|Procedure|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583409|NCT00558246|E2|Reported Event|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583410|NCT00558246|E1|Reported Event|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
583411|NCT00558103|B6|Baseline|Total|Total of all reporting groups
583412|NCT00558103|B5|Baseline|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583413|NCT00558103|B4|Baseline|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
583414|NCT00558103|B3|Baseline|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583415|NCT00558103|B2|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
583416|NCT00558103|B1|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
583417|NCT00558103|P6|Participant Flow|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
583418|NCT00558103|P5|Participant Flow|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
584200|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
583419|NCT00558103|P4|Participant Flow|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
583420|NCT00558103|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583421|NCT00558103|P2|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
583422|NCT00558103|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
583423|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583424|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
583425|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583426|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
583427|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
583428|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583429|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
583430|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583431|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
583432|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
583433|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583434|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
583435|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583436|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
583437|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
583438|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583439|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
583440|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583441|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
583485|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583442|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
583443|NCT00558103|E6|Reported Event|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
583444|NCT00558103|E5|Reported Event|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583445|NCT00558103|E4|Reported Event|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
583446|NCT00558103|E3|Reported Event|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
583447|NCT00558103|E2|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
583448|NCT00558103|E1|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
583449|NCT00558064|B3|Baseline|Total|Total of all reporting groups
583450|NCT00558064|B2|Baseline|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583451|NCT00558064|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583452|NCT00558064|P2|Participant Flow|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583453|NCT00558064|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583454|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583455|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583456|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583457|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583458|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583459|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583460|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583461|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583462|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583463|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583464|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583465|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583466|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583467|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583468|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583469|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583470|NCT00558064|E2|Reported Event|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
583471|NCT00558064|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
583472|NCT00558025|B3|Baseline|Total|Total of all reporting groups
583473|NCT00558025|B2|Baseline|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583474|NCT00558025|B1|Baseline|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583475|NCT00558025|P2|Participant Flow|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583476|NCT00558025|P1|Participant Flow|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
583477|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583478|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583479|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583480|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583481|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583482|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583483|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583484|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583486|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583487|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583488|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583489|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583490|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583491|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583492|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583493|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583494|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583495|NCT00558025|E2|Reported Event|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
583496|NCT00558025|E1|Reported Event|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
583497|NCT00558012|B3|Baseline|Total|Total of all reporting groups
583498|NCT00558012|B2|Baseline|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
583499|NCT00558012|B1|Baseline|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
583500|NCT00558012|P2|Participant Flow|Placebo|"Placebo~One-time dose: Intravenous saline"
583501|NCT00558012|P1|Participant Flow|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
583502|NCT00558012|O2|Outcome|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
583503|NCT00558012|O1|Outcome|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
583504|NCT00558012|E2|Reported Event|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
583505|NCT00558012|E1|Reported Event|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
583506|NCT00557947|B1|Baseline|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
583507|NCT00557947|P1|Participant Flow|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
583508|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
583509|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
583510|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
583511|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
583512|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
583513|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
583514|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
583515|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
583516|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
583517|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
583518|NCT00557947|E4|Reported Event|Unrelated|Reported events per local regulatory requirements but not related to either device or procedure.
583519|NCT00557947|E3|Reported Event|Procedure|
583520|NCT00557947|E2|Reported Event|Suture|Suture - Incision segments are randomized & patient is own control.
583521|NCT00557947|E1|Reported Event|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
583522|NCT00557856|B1|Baseline|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
583523|NCT00557856|P9|Participant Flow|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583524|NCT00557856|P8|Participant Flow|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583525|NCT00557856|P7|Participant Flow|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583526|NCT00557856|P6|Participant Flow|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583527|NCT00557856|P5|Participant Flow|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583528|NCT00557856|P4|Participant Flow|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583529|NCT00557856|P3|Participant Flow|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583530|NCT00557856|P2|Participant Flow|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583531|NCT00557856|P1|Participant Flow|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583532|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583533|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583534|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583535|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583536|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583537|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583538|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583539|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583540|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583541|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583542|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583543|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583544|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583545|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583546|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583547|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583548|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583549|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583550|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583551|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583552|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583553|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583554|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583555|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583556|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583557|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583558|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583559|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583560|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583561|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583562|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583563|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583564|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583565|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583566|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583567|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583568|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583569|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583570|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583571|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583572|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583573|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583574|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583575|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583576|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583577|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583578|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583579|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583580|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
585617|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
583581|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583582|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583583|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583584|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583585|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583586|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583587|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583588|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583589|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583590|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583591|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583592|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583593|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583594|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583595|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583596|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583597|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583598|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583599|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583600|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583601|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583602|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583603|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583604|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583605|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583606|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583607|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
585618|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
583608|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583609|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583610|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583611|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583612|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583613|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583614|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583615|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583616|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583617|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583618|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583619|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583620|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583621|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583622|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583623|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583624|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583625|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583626|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583627|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583628|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583629|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583630|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583631|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583632|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583633|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583634|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
585619|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
583635|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583636|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583637|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583638|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583639|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583640|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583641|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583642|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583643|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583644|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583645|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583646|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583647|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583648|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583649|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583650|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583651|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583652|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583653|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583654|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583655|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583656|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583657|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583658|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583659|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583660|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583661|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
585620|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
583662|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583663|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583664|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583665|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583666|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583667|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583668|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583669|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583670|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583671|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583672|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583673|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583674|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583675|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583676|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583677|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583678|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583679|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583680|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583681|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583682|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583683|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583684|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583685|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583686|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583687|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583688|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
585621|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
583689|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583690|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583691|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583692|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583693|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583694|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583695|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583696|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583697|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583698|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583699|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583700|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583701|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583702|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583703|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583704|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583705|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583706|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583707|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583708|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583709|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583710|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583711|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583712|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583713|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583714|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583715|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
585622|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
583716|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583717|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583718|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583719|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583720|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583721|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583722|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
583723|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
583724|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
583725|NCT00557856|E1|Reported Event|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
583726|NCT00557830|B4|Baseline|Total|Total of all reporting groups
583727|NCT00557830|B3|Baseline|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583728|NCT00557830|B2|Baseline|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583729|NCT00557830|B1|Baseline|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583730|NCT00557830|P3|Participant Flow|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583731|NCT00557830|P2|Participant Flow|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583732|NCT00557830|P1|Participant Flow|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583764|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583765|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
583733|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583734|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583735|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583736|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583737|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583738|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583739|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583740|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583741|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583742|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583743|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583798|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583744|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583745|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583746|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583747|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583748|NCT00557830|E3|Reported Event|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
583749|NCT00557830|E2|Reported Event|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
583750|NCT00557830|E1|Reported Event|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
583751|NCT00557622|B3|Baseline|Total|Total of all reporting groups
583752|NCT00557622|B2|Baseline|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583753|NCT00557622|B1|Baseline|Placebo|Placebo once daily (OD)
583754|NCT00557622|P2|Participant Flow|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583755|NCT00557622|P1|Participant Flow|Placebo|Placebo once daily (OD)
583756|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583757|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
583758|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583759|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
583760|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583761|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
583762|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583763|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
584293|NCT00556894|E1|Reported Event|CF101 0.1mg|CF101 0.1mg q12 for 12 weeks
583766|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583767|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
583768|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583769|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
583770|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583771|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
583772|NCT00557622|E2|Reported Event|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
583773|NCT00557622|E1|Reported Event|Placebo|Placebo once daily (OD)
583774|NCT00557505|B10|Baseline|Total|Total of all reporting groups
583775|NCT00557505|B9|Baseline|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583776|NCT00557505|B8|Baseline|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583777|NCT00557505|B7|Baseline|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583778|NCT00557505|B6|Baseline|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583779|NCT00557505|B5|Baseline|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583780|NCT00557505|B4|Baseline|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583781|NCT00557505|B3|Baseline|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583782|NCT00557505|B2|Baseline|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583783|NCT00557505|B1|Baseline|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583784|NCT00557505|P9|Participant Flow|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583785|NCT00557505|P8|Participant Flow|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583786|NCT00557505|P7|Participant Flow|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583787|NCT00557505|P6|Participant Flow|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583788|NCT00557505|P5|Participant Flow|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583789|NCT00557505|P4|Participant Flow|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583790|NCT00557505|P3|Participant Flow|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583791|NCT00557505|P2|Participant Flow|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583792|NCT00557505|P1|Participant Flow|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583793|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583794|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583795|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583796|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583797|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583799|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583800|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583801|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583802|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583803|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583804|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583805|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583806|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583807|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583808|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583809|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583810|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583811|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583812|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583813|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583814|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583815|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583816|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583817|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583818|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583819|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583820|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583821|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583822|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583823|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583824|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583825|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583826|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583827|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583828|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583829|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
584294|NCT00556712|B3|Baseline|Total|Total of all reporting groups
583830|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583831|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583832|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583833|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583834|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583835|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583836|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583837|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583838|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583839|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583840|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583841|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583842|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583843|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583844|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583845|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583846|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583847|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583848|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583849|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583850|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583851|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583852|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583853|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583854|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583855|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583856|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583857|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583858|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583859|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583860|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
584745|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
583861|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583862|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583863|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583864|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583865|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583866|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583867|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583868|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583869|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583870|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583871|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583872|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583873|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583874|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583875|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583876|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583877|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583878|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583879|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583880|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583881|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583882|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583883|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583884|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583885|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583886|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583887|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583888|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583889|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583890|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583891|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
584746|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
583892|NCT00557505|O3|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583893|NCT00557505|O2|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583894|NCT00557505|O1|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583895|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583896|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583897|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583898|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583899|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583900|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583901|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583902|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583903|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583904|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583905|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583906|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583907|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583908|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583909|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583910|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583911|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583912|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583913|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583914|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583915|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583916|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583917|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583918|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583919|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583920|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583921|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583922|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
584747|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
583923|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583924|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583925|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583926|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583927|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583928|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583929|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583930|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583931|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583932|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583933|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583934|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583935|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583936|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583937|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583938|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583939|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583940|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583941|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583942|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583943|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583944|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583945|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583946|NCT00557505|E9|Reported Event|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583947|NCT00557505|E8|Reported Event|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583948|NCT00557505|E7|Reported Event|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
583949|NCT00557505|E6|Reported Event|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583950|NCT00557505|E5|Reported Event|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583951|NCT00557505|E4|Reported Event|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583952|NCT00557505|E3|Reported Event|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583953|NCT00557505|E2|Reported Event|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
589024|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
583954|NCT00557505|E1|Reported Event|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
583955|NCT00557492|B1|Baseline|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583956|NCT00557492|P1|Participant Flow|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583957|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583958|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583959|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583960|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583961|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583962|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583963|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583964|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583965|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583966|NCT00557492|E1|Reported Event|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
583967|NCT00557466|B7|Baseline|Total|Total of all reporting groups
583968|NCT00557466|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583969|NCT00557466|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
583970|NCT00557466|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583971|NCT00557466|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583972|NCT00557466|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583973|NCT00557466|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583974|NCT00557466|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583975|NCT00557466|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
583976|NCT00557466|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583977|NCT00557466|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583978|NCT00557466|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583979|NCT00557466|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583980|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583981|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
583982|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583983|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583984|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583985|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583986|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583987|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
583988|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583989|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583990|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583991|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583992|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583993|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
583994|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583995|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583996|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583997|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583998|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
583999|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
584000|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584001|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584002|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584003|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584004|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584005|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
584006|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584007|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584008|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584009|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584010|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584011|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
584012|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584013|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584014|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584015|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584016|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589025|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
584017|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
584018|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584019|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584020|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584021|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584022|NCT00557466|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584023|NCT00557466|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
584024|NCT00557466|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584025|NCT00557466|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584026|NCT00557466|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584027|NCT00557466|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
584028|NCT00557440|B4|Baseline|Total|Total of all reporting groups
584029|NCT00557440|B3|Baseline|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
584030|NCT00557440|B2|Baseline|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
584031|NCT00557440|B1|Baseline|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
584032|NCT00557440|P3|Participant Flow|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
584033|NCT00557440|P2|Participant Flow|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
584060|NCT00557362|P2|Participant Flow|Topical Natamycin Without Corneal De-epithelialization|"Topical natamycin without corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584748|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584034|NCT00557440|P1|Participant Flow|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
584035|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
584036|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
584037|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
584038|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
584039|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
584040|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
584041|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
584042|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
584043|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
584044|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
584045|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
584046|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
584047|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
584048|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
584049|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
584050|NCT00557440|E3|Reported Event|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
584051|NCT00557440|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
584052|NCT00557440|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
584053|NCT00557362|B5|Baseline|Total|Total of all reporting groups
584054|NCT00557362|B4|Baseline|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
584055|NCT00557362|B3|Baseline|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
584056|NCT00557362|B2|Baseline|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
584057|NCT00557362|B1|Baseline|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
584058|NCT00557362|P4|Participant Flow|Topical Voriconazole Without Corneal De-epithelialization|"Topical voriconazole without corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584059|NCT00557362|P3|Participant Flow|Topical Voriconazole With Corneal De-epithelialization|"Topical voriconazole with corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
584124|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584061|NCT00557362|P1|Participant Flow|Topical Natamycin With Corneal De-epithelialization|"Topical natamycin with corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
584062|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584063|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584064|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584065|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584066|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 5 patients in the natamycin arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
584067|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 9 patients in the voriconazole arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
584068|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
584069|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
584070|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584071|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
584072|NCT00557362|E4|Reported Event|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
584073|NCT00557362|E3|Reported Event|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
584074|NCT00557362|E2|Reported Event|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
584075|NCT00557362|E1|Reported Event|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
584076|NCT00557349|B3|Baseline|Total|Total of all reporting groups
584077|NCT00557349|B2|Baseline|Famotidine|40 mg daily for 14 weeks
584078|NCT00557349|B1|Baseline|Omeprazole|40 mg daily for 14 weeks
584079|NCT00557349|P2|Participant Flow|Famotidine|40 mg daily at bedtime for 14 weeks
584080|NCT00557349|P1|Participant Flow|Omeprazole|40 mg daily at bedtime for 14 weeks
584081|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
584082|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
584083|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
584084|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
584085|NCT00557349|E2|Reported Event|Famotidine|40 mg daily for 14 weeks
584086|NCT00557349|E1|Reported Event|Omeprazole|40 mg daily for 14 weeks
584087|NCT00557323|B1|Baseline|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
584088|NCT00557323|P1|Participant Flow|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
584125|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584126|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584127|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584089|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
584090|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
584091|NCT00557323|E1|Reported Event|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
584092|NCT00557310|B1|Baseline|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584093|NCT00557310|P1|Participant Flow|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584094|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584095|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584096|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584097|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584098|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584099|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584100|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584101|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584102|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584103|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584104|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584105|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584106|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584107|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584108|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584109|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584110|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584111|NCT00557310|E1|Reported Event|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
584112|NCT00557284|B3|Baseline|Total|Total of all reporting groups
584113|NCT00557284|B2|Baseline|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584114|NCT00557284|B1|Baseline|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584115|NCT00557284|P2|Participant Flow|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584116|NCT00557284|P1|Participant Flow|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584117|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584118|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584119|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584120|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584121|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584122|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584123|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584128|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584129|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584130|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584131|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584132|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584133|NCT00557284|E2|Reported Event|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
584134|NCT00557284|E1|Reported Event|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
584135|NCT00557245|B4|Baseline|Total|Total of all reporting groups
584136|NCT00557245|B3|Baseline|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584137|NCT00557245|B2|Baseline|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584138|NCT00557245|B1|Baseline|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584139|NCT00557245|P3|Participant Flow|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584140|NCT00557245|P2|Participant Flow|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584141|NCT00557245|P1|Participant Flow|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584142|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
584143|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584144|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584145|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
584146|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584147|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584148|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
584149|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584150|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584151|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584152|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584153|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584154|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
584155|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584156|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584157|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584158|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584159|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584160|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584161|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584162|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584163|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
584164|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584165|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584166|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584167|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584168|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584169|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584170|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584171|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584172|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584173|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584174|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584175|NCT00557245|E3|Reported Event|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
584176|NCT00557245|E2|Reported Event|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
584177|NCT00557245|E1|Reported Event|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
584178|NCT00557076|B3|Baseline|Total|Total of all reporting groups
584179|NCT00557076|B2|Baseline|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
584180|NCT00557076|B1|Baseline|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
584181|NCT00557076|P2|Participant Flow|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
584182|NCT00557076|P1|Participant Flow|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
584183|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
584184|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
584185|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
584186|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
584187|NCT00557076|E2|Reported Event|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
584188|NCT00557076|E1|Reported Event|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
584189|NCT00556998|B1|Baseline|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584190|NCT00556998|P1|Participant Flow|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584191|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584192|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584193|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584194|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
584195|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
584196|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
584197|NCT00556998|O1|Outcome|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2-7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584198|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
584199|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
584201|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584202|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584203|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584204|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
584205|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
584206|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
584207|NCT00556998|E2|Reported Event|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
584208|NCT00556998|E1|Reported Event|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
584209|NCT00556972|B1|Baseline|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
584210|NCT00556972|P1|Participant Flow|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
584211|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
584212|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
584213|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
584214|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
584215|NCT00556972|E1|Reported Event|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
584216|NCT00556946|B1|Baseline|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser.
584217|NCT00556946|P1|Participant Flow|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains: using Combined Photodynamic and Pulsed Dye Laser.
584218|NCT00556946|O1|Outcome|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
584219|NCT00556946|E1|Reported Event|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
584220|NCT00556933|B5|Baseline|Total|Total of all reporting groups
584221|NCT00556933|B4|Baseline|Divided-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofeti|"Kidney transplant receive the same treatment as in Group 2, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.."
584222|NCT00556933|B3|Baseline|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant receive the same treatment as in Group 1, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584223|NCT00556933|B2|Baseline|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584295|NCT00556712|B2|Baseline|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584224|NCT00556933|B1|Baseline|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg of rATG as a single dose administered intravenously over <24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584225|NCT00556933|P4|Participant Flow|Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
584226|NCT00556933|P3|Participant Flow|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
584227|NCT00556933|P2|Participant Flow|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
584228|NCT00556933|P1|Participant Flow|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
584229|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584230|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584231|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584232|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584233|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584296|NCT00556712|B1|Baseline|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584392|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584234|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584235|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584236|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584237|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584238|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584239|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584240|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584241|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
584242|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
584243|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584244|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584245|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584246|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584247|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584248|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584249|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584773|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584250|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584251|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584252|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584253|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584254|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584255|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584256|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584257|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4), Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584749|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584258|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584259|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584260|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584261|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584262|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584263|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584264|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584265|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584750|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584266|NCT00556933|O3|Outcome|Ingle-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584267|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584268|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584269|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
584270|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
584271|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584272|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584273|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
584274|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
584275|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584276|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584277|NCT00556933|E4|Reported Event|Group 4|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
584278|NCT00556933|E3|Reported Event|Group 3|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
584279|NCT00556933|E2|Reported Event|Group 2|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584280|NCT00556933|E1|Reported Event|Group 1|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
584281|NCT00556894|B4|Baseline|Total|Total of all reporting groups
584282|NCT00556894|B3|Baseline|Placebo|CF101: orally q12h
584283|NCT00556894|B2|Baseline|CF101 1mg|CF101: orally q12h
584284|NCT00556894|B1|Baseline|CF101 0.1mg|CF101: orally q12h
584285|NCT00556894|P3|Participant Flow|Placebo|Matching placebo
584286|NCT00556894|P2|Participant Flow|CF101 1mg|CF101 1mg orally q12 for 12 weeks
584287|NCT00556894|P1|Participant Flow|CF101 0.1mg|CF101 0.1mg orally q12 for 12 weeks
584288|NCT00556894|O3|Outcome|Placebo|Placebo orally q12
584289|NCT00556894|O2|Outcome|CF101 1mg|CF101 1mg orally q12
584290|NCT00556894|O1|Outcome|CF101 0.1mg|CF101 0.1mg orally q12
584291|NCT00556894|E3|Reported Event|Placebo|Matching Placebo q12 for 12 weeks
584292|NCT00556894|E2|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
584297|NCT00556712|P2|Participant Flow|Erlotinib, 150 Milligrams Per Day (mg/Day)|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584298|NCT00556712|P1|Participant Flow|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584299|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584300|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584301|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584302|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584303|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584304|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584305|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584306|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584307|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584308|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584309|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584310|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584387|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584311|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584312|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584313|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584314|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584315|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584316|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584317|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584318|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584319|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584320|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584321|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584322|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584323|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584324|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584388|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584774|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584325|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584326|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584327|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584328|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584329|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584330|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584331|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584332|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584333|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584334|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584335|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584336|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584337|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584338|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584389|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584751|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584339|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584340|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584341|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584342|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584343|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584344|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584345|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584346|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584347|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584348|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584349|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584350|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584351|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584352|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584390|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584752|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584353|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584354|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584355|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584356|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584357|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584358|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584359|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584360|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584361|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584362|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584363|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584364|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584365|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584366|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584391|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584775|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584367|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584368|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584369|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584370|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584371|NCT00556712|E2|Reported Event|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584372|NCT00556712|E1|Reported Event|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
584373|NCT00556673|B3|Baseline|Total|Total of all reporting groups
584374|NCT00556673|B2|Baseline|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
584375|NCT00556673|B1|Baseline|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
584376|NCT00556673|P2|Participant Flow|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
584377|NCT00556673|P1|Participant Flow|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
584378|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584379|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584380|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584381|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584382|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584383|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584384|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584385|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584386|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584393|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584394|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584395|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584396|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584397|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584398|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584399|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584400|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584401|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584402|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584403|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584404|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584405|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584406|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584407|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584408|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584409|NCT00556673|E3|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
584410|NCT00556673|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
584411|NCT00556673|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
584412|NCT00556543|B1|Baseline|All Study Subjects|
584413|NCT00556543|P1|Participant Flow|All Study Subjects|
584414|NCT00556543|O1|Outcome|All Study Subjects|
584415|NCT00556543|O1|Outcome|All Study Subjects|
584416|NCT00556543|O1|Outcome|All Study Subjects|
584417|NCT00556543|O1|Outcome|All Study Subjects|
584418|NCT00556543|O1|Outcome|All Study Subjects|
584419|NCT00556543|O1|Outcome|All Study Subjects|
584420|NCT00556543|O1|Outcome|All Study Subjects|
584421|NCT00556543|O1|Outcome|All Study Subjects|
584422|NCT00556543|O1|Outcome|All Study Subjects|
584423|NCT00556543|O1|Outcome|All Study Subjects|
584424|NCT00556543|O2|Outcome|Rib Fracture Repair for Persistent Rib Fracture Non-Union|Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 – 56 months) post-injury at the time of repair.
584425|NCT00556543|O1|Outcome|Acute Rib Fracture Repair|These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 – 18 days) post-injury.
584426|NCT00556543|E2|Reported Event|Chronic Rib Fracture Non-union Repair|
584427|NCT00556543|E1|Reported Event|Acute Rib Fracture Repair|
584428|NCT00556504|B3|Baseline|Total|Total of all reporting groups
584429|NCT00556504|B2|Baseline|Placebo|Placebo with convetional treatment for HCV patients
584430|NCT00556504|B1|Baseline|TCM-700C|TCM-700C, an add-on drug to conventional treatment of Hepatitis C
584431|NCT00556504|P2|Participant Flow|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584432|NCT00556504|P1|Participant Flow|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584433|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584434|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584435|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584753|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584436|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584437|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584438|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584439|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584440|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584441|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584442|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584443|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584444|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584445|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584446|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
584447|NCT00556504|E2|Reported Event|Placebo (Safety Population)|Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
584448|NCT00556504|E1|Reported Event|TCM-700C (Safety Population)|TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C
584449|NCT00556491|B3|Baseline|Total|Total of all reporting groups
584450|NCT00556491|B2|Baseline|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
584451|NCT00556491|B1|Baseline|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
584452|NCT00556491|P2|Participant Flow|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
584453|NCT00556491|P1|Participant Flow|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
584454|NCT00556491|O2|Outcome|Placebo|re-operation
584455|NCT00556491|O1|Outcome|Minocycline|re-operation
584456|NCT00556491|O2|Outcome|Placebo|stroke post op
584457|NCT00556491|O1|Outcome|Minocycline|Stroke post-op
584458|NCT00556491|O2|Outcome|Placebo|Infections post-operative
584459|NCT00556491|O1|Outcome|Minocycline|Infections post-operative
584460|NCT00556491|O2|Outcome|Placebo|On vent > 48 hours
584461|NCT00556491|O1|Outcome|Minocycline|On vent > 48 hours
584462|NCT00556491|O2|Outcome|Placebo|Post op hospital days
584463|NCT00556491|O1|Outcome|Minocycline|Post Op hospital days
584464|NCT00556491|O2|Outcome|Placebo|
584465|NCT00556491|O1|Outcome|Minocycline|
584466|NCT00556491|E2|Reported Event|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
584467|NCT00556491|E1|Reported Event|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
584468|NCT00556478|B3|Baseline|Total|Total of all reporting groups
584469|NCT00556478|B2|Baseline|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584565|NCT00556322|B2|Baseline|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584754|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584755|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584756|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
589026|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
584470|NCT00556478|B1|Baseline|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584471|NCT00556478|P2|Participant Flow|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584472|NCT00556478|P1|Participant Flow|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584473|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584474|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584475|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584476|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584477|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584660|NCT00555997|B1|Baseline|Placebo/Ziprasidone|Received placebo in first phase and ziprasidone in second phase
584661|NCT00555997|P4|Participant Flow|Phase 2 Placebo|Patients who received placebo in phase 2.
584478|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584479|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584480|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584481|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584482|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584483|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584484|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584485|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584662|NCT00555997|P3|Participant Flow|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
584663|NCT00555997|P2|Participant Flow|Phase 1 Placebo|Subjects taking placebo in the first phase.
584664|NCT00555997|P1|Participant Flow|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
584486|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584487|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584488|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584489|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584490|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584491|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584492|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584493|NCT00556478|E3|Reported Event|Open Label Phase|"Subjects will all receive PSD502 if they wish to continue in the trial.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584665|NCT00555997|O4|Outcome|Phase 2 Placebo|Patients who received placebo in phase 2.
589027|NCT00546871|O5|Outcome|Study Extension, SC Administration|
584494|NCT00556478|E2|Reported Event|Double-Blind Placebo|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584495|NCT00556478|E1|Reported Event|Double-Blind Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
584496|NCT00556452|B4|Baseline|Total|Total of all reporting groups
584497|NCT00556452|B3|Baseline|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
584498|NCT00556452|B2|Baseline|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
584499|NCT00556452|B1|Baseline|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
584500|NCT00556452|P3|Participant Flow|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
584501|NCT00556452|P2|Participant Flow|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
584502|NCT00556452|P1|Participant Flow|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
584503|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
584504|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
584505|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
584506|NCT00556452|O1|Outcome|Clo/Bu4|Experimental: Clo/BU4
584507|NCT00556452|E1|Reported Event|Clo/Bu4|
584508|NCT00556439|B5|Baseline|Total|Total of all reporting groups
584509|NCT00556439|B4|Baseline|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
584666|NCT00555997|O3|Outcome|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
584667|NCT00555997|O2|Outcome|Phase 1 Placebo|Subjects taking placebo in the first phase.
584668|NCT00555997|O1|Outcome|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
584669|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
584510|NCT00556439|B3|Baseline|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
584511|NCT00556439|B2|Baseline|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
584512|NCT00556439|B1|Baseline|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
584513|NCT00556439|P4|Participant Flow|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
584514|NCT00556439|P3|Participant Flow|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
584515|NCT00556439|P2|Participant Flow|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
584516|NCT00556439|P1|Participant Flow|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
584670|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
584671|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
584672|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
584776|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584517|NCT00556439|O4|Outcome|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
584518|NCT00556439|O3|Outcome|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
584519|NCT00556439|O2|Outcome|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
584520|NCT00556439|O1|Outcome|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
584521|NCT00556439|E4|Reported Event|Group D - Placebo in Takayasu Arteritis|"This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D."
584522|NCT00556439|E3|Reported Event|Group C - Abatacept in Takayasu Arteritis|"This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C."
584523|NCT00556439|E2|Reported Event|Group B - Placebo in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B."
584673|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
584674|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
584675|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
584676|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
584524|NCT00556439|E1|Reported Event|Group A - Abatacept in Giant Cell Arteritis|"This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:~Participants weighing less than 60kg will receive 500mg of abatacept.~Participants weighing 60 to 100kg will receive 750mg of abatacept.~Participants weighing more than 100kg will receive 1000mg of abatacept.~At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A."
584525|NCT00556426|B1|Baseline|Participants Receiving a Filter|Patients who were at temporary, increased risk of pulmonary embolism requiring inferior vena cava (IVC) interruption, and for whom Recovery G2 Filter retrieval could reasonably be expected to occur within 6 months of device placement.
584526|NCT00556426|P1|Participant Flow|All Patients Receiving the Filter|All enrolled subjects
584527|NCT00556426|O1|Outcome|Fractured Filters|retrieval of the filter such that the entire filter is retrieved
584528|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
584529|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
584530|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
584531|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
584532|NCT00556426|E1|Reported Event|All Patients Receiving the Filter|All enrolled subjects
584533|NCT00556400|B3|Baseline|Total|Total of all reporting groups
584534|NCT00556400|B2|Baseline|Sugar Pill|
584535|NCT00556400|B1|Baseline|Lo-ovral|1 tablet of lo-ovral is administered twice a day
584536|NCT00556400|P2|Participant Flow|Sugar Pill|
584537|NCT00556400|P1|Participant Flow|Lo-ovral|1 tablet of lo-ovral is administered twice a day
584538|NCT00556400|O2|Outcome|Sugar Pill|
584539|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
584540|NCT00556400|O2|Outcome|Sugar Pill|
584541|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
584542|NCT00556400|O2|Outcome|Sugar Pill|
584543|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
584544|NCT00556400|E1|Reported Event|Sugar Pill|
584545|NCT00556374|B3|Baseline|Total|Total of all reporting groups
584546|NCT00556374|B2|Baseline|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584547|NCT00556374|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584548|NCT00556374|P2|Participant Flow|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584549|NCT00556374|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy (AIT).
584550|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584551|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584552|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584553|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584554|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584555|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584556|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584557|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584558|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584559|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584560|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584561|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584562|NCT00556374|E2|Reported Event|Denosumab 60mg Q6M|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy
584563|NCT00556374|E1|Reported Event|Placebo Q6M|Participants received placebo subcutaneous injection once every 6 months (Q6M). All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
584564|NCT00556322|B3|Baseline|Total|Total of all reporting groups
584677|NCT00555997|E2|Reported Event|Placebo|Adverse events experienced when taking placebo
584566|NCT00556322|B1|Baseline|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584567|NCT00556322|P2|Participant Flow|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584568|NCT00556322|P1|Participant Flow|Comparator|Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584569|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584570|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584571|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584572|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584573|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584574|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584575|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584576|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584577|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584578|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584579|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584580|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584581|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584678|NCT00555997|E1|Reported Event|Ziprasidone|Adverse events experienced by subjects while taking ziprasidone
584679|NCT00555906|B4|Baseline|Total|Total of all reporting groups
584757|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584758|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584777|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584582|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584583|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584584|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584585|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584586|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584587|NCT00556322|O2|Outcome|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day as a tablet until disease progression, unacceptable toxicity or death.
584588|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584589|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584590|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable t oxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584591|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584592|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584593|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584594|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584595|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584596|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584597|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584759|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584760|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584761|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584762|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584778|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584598|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584599|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584600|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584601|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584602|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel l75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584603|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584604|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584605|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584606|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584607|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584608|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584609|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584610|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584611|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
584612|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584613|NCT00556322|E2|Reported Event|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.
584763|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584764|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584765|NCT00555880|E2|Reported Event|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl (10-30mg) the next day.
584766|NCT00555880|E1|Reported Event|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl (10-30mg) followed by placebo the next day.
584614|NCT00556322|E1|Reported Event|Comparator|Participants received either Alimta 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
584615|NCT00556166|B1|Baseline|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
584616|NCT00556166|P1|Participant Flow|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
584617|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
584618|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
584619|NCT00556166|E1|Reported Event|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
584620|NCT00556140|B1|Baseline|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
584621|NCT00556140|P1|Participant Flow|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
584622|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
584623|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
584624|NCT00556140|E1|Reported Event|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
584625|NCT00556075|B4|Baseline|Total|Total of all reporting groups
584626|NCT00556075|B3|Baseline|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
584627|NCT00556075|B2|Baseline|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
584628|NCT00556075|B1|Baseline|Placebo|Placebo: 1 capsule daily for 4 months
584629|NCT00556075|P3|Participant Flow|B 50 mg|Proellex 50 mg: 2 capsules daily for 4 months
584630|NCT00556075|P2|Participant Flow|A 25 mg|Proellex 25 mg: 1 capsule daily for 4 months
584631|NCT00556075|P1|Participant Flow|C Placebo|Placebo: 1 capsule daily for 4 months
584632|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
584633|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
584634|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
584635|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
584636|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
584637|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
584638|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg~Proellex 50 mg: 2 capsules daily for 4 months"
584639|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg~Proellex 25 mg: 1 capsule daily for 4 months"
584640|NCT00556075|O1|Outcome|Placebo|"Placebo~Placebo: 1 capsule daily for 4 months"
584641|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg~Proellex 50 mg: 2 capsules daily for 4 months"
584642|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg~Proellex 25 mg: 1 capsule daily for 4 months"
584643|NCT00556075|O1|Outcome|Placebo|Placebo: 1capsule daily for 4 months
584644|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
584645|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
584646|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
584647|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
584648|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
584649|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
584650|NCT00556075|E3|Reported Event|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
584651|NCT00556075|E2|Reported Event|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
584652|NCT00556075|E1|Reported Event|Placebo|Placebo: 1 capsule daily for 4 months
584653|NCT00556049|B1|Baseline|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
584654|NCT00556049|P1|Participant Flow|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
584655|NCT00556049|O1|Outcome|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
584656|NCT00556049|E1|Reported Event|Neutropenia|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
584657|NCT00555997|B4|Baseline|Total|Total of all reporting groups
584658|NCT00555997|B3|Baseline|Ziprasidone|Subjects received ziprasidone throughout study
584659|NCT00555997|B2|Baseline|Placebo|Subjects received placebo throughout study
584680|NCT00555906|B3|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584681|NCT00555906|B2|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584682|NCT00555906|B1|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584683|NCT00555906|P5|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584684|NCT00555906|P4|Participant Flow|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584685|NCT00555906|P3|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584686|NCT00555906|P2|Participant Flow|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584767|NCT00555750|B3|Baseline|Total|Total of all reporting groups
584768|NCT00555750|B2|Baseline|Placebo|nightly administration of placebo before bed
584769|NCT00555750|B1|Baseline|Active|active medication administration nightly before bed
584770|NCT00555750|P2|Participant Flow|Placebo|nightly placebo (identical tablet to active medication) oral administration ~30 min before bed
584771|NCT00555750|P1|Participant Flow|Eszopiclone|nightly active medication (eszopiclone, 3 mg tablet) oral administration ~30 min before bed
584687|NCT00555906|P1|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584688|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584689|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584690|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584691|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584692|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584693|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584726|NCT00555893|E1|Reported Event|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
584727|NCT00555880|B3|Baseline|Total|Total of all reporting groups
584694|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584695|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584696|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584697|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584698|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584699|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584700|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584728|NCT00555880|B2|Baseline|Placebo/Midodrine|Participants received matching Placebo followed by a single oral dose of Midodrine HCl the next day
584729|NCT00555880|B1|Baseline|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl followed by matching Placebo the next day
584730|NCT00555880|P2|Participant Flow|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl the next day
584731|NCT00555880|P1|Participant Flow|Midodrine/Placebo|Participants received a single oral dose of Midodrine hydrochloride (HCl) followed by matching Placebo the next day
584732|NCT00555880|O1|Outcome|All Participants|All randomized participants
584701|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584702|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584703|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584704|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584705|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584706|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584707|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584733|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584734|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584735|NCT00555880|O1|Outcome|All Participants|All randomized participants
584736|NCT00555880|O1|Outcome|All Participants|All randomized participants
584737|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584738|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584772|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584708|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584709|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584710|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584711|NCT00555906|E5|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584712|NCT00555906|E4|Reported Event|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584713|NCT00555906|E3|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584714|NCT00555906|E2|Reported Event|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584739|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584740|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584741|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584742|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584743|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
584715|NCT00555906|E1|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
584716|NCT00555893|B3|Baseline|Total|Total of all reporting groups
584717|NCT00555893|B2|Baseline|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
584718|NCT00555893|B1|Baseline|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
584719|NCT00555893|P2|Participant Flow|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
584720|NCT00555893|P1|Participant Flow|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
584721|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
584722|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
584723|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
584724|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
584725|NCT00555893|E2|Reported Event|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
584744|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
584779|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584780|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584781|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584782|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584783|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584784|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584785|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584786|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584787|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584788|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584789|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584790|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584791|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584792|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584793|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584794|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584795|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584796|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
584797|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
584798|NCT00555750|E2|Reported Event|Placebo|nightly administration of placebo before bed
584799|NCT00555750|E1|Reported Event|Active|active medication administration nightly before bed
584800|NCT00555672|B3|Baseline|Total|Total of all reporting groups
584801|NCT00555672|B2|Baseline|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584802|NCT00555672|B1|Baseline|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584803|NCT00555672|P2|Participant Flow|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584804|NCT00555672|P1|Participant Flow|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584805|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584806|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584807|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584808|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584809|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584810|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584811|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584812|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584836|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584813|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584814|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584815|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584816|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584817|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584818|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584819|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584820|NCT00555672|E2|Reported Event|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584821|NCT00555672|E1|Reported Event|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
584822|NCT00555620|B7|Baseline|Total|Total of all reporting groups
584823|NCT00555620|B6|Baseline|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584824|NCT00555620|B5|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584825|NCT00555620|B4|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584826|NCT00555620|B3|Baseline|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584827|NCT00555620|B2|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584828|NCT00555620|B1|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
584829|NCT00555620|P6|Participant Flow|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584830|NCT00555620|P5|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584831|NCT00555620|P4|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584832|NCT00555620|P3|Participant Flow|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584833|NCT00555620|P2|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584834|NCT00555620|P1|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
584835|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584978|NCT00555568|E1|Reported Event|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
584837|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584838|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584839|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584840|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
584841|NCT00555620|O5|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584842|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584843|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584844|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584845|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
584846|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584847|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584848|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584849|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584850|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584851|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
584852|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584853|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584854|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584855|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584856|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584857|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584858|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584859|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584860|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584861|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584862|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584863|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584864|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584979|NCT00555477|B3|Baseline|Total|Total of all reporting groups
585595|NCT00554294|B1|Baseline|Control Group|Schools did not receive any intervention.
584865|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584866|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584867|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584868|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584869|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584870|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584871|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584872|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584873|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584874|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584875|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584876|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584877|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584878|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584879|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584880|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584881|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584882|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584883|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584884|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584885|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584886|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584887|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584888|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584889|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584890|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584891|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584892|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584893|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584894|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
585435|NCT00554996|O1|Outcome|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
584895|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584896|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584897|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584898|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584899|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584900|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584901|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584902|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584903|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584904|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584905|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584906|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584907|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584908|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584909|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584910|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584911|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584912|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584913|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584914|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584915|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584916|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584917|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584918|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584919|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584920|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584921|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584922|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584923|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584924|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
585436|NCT00554996|E1|Reported Event|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
584925|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584926|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584927|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584928|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584929|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584930|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584931|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584932|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584933|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584934|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584935|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584936|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584937|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584938|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
584939|NCT00555620|E6|Reported Event|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584940|NCT00555620|E5|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584941|NCT00555620|E4|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584942|NCT00555620|E3|Reported Event|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584943|NCT00555620|E2|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
584944|NCT00555620|E1|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
584945|NCT00555581|B1|Baseline|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584946|NCT00555581|P1|Participant Flow|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584947|NCT00555581|O1|Outcome|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
585045|NCT00555321|B1|Baseline|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
584948|NCT00555581|O1|Outcome|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584949|NCT00555581|O1|Outcome|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584950|NCT00555581|O1|Outcome|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584951|NCT00555581|O1|Outcome|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584952|NCT00555581|O1|Outcome|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584953|NCT00555581|E1|Reported Event|400 mg Daily of Imatinib Mesylate|"All patients were treated with imatinib mesylate at a target dose of 400 mg daily by mouth for 12 months. Dose modifications and interruptions were made for AE and were recorded. After 12 months of treatment, imatinib was stopped for 3 months. Patients were reassessed and offered entrance to an extension phase of the trial.~Imatinib Mesylate: In initial phase, patients will be treated with Gleevec 400 mg daily for 12 months. In the extension phase, patients will be treated with Gleevec 400 mg daily for 27 months."
584954|NCT00555568|B4|Baseline|Total|Total of all reporting groups
584955|NCT00555568|B3|Baseline|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584956|NCT00555568|B2|Baseline|Arm 2: Clinician-Led Group|"Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician~recovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician"
584957|NCT00555568|B1|Baseline|Arm 1: Peer-Led Group|"Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators~recovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators"
584958|NCT00555568|P3|Participant Flow|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584959|NCT00555568|P2|Participant Flow|Arm 2: Clinician Led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
584960|NCT00555568|P1|Participant Flow|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
584961|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584962|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
584963|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
584964|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584965|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
584966|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
584967|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584968|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
584969|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
584970|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584971|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
584972|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
584973|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584974|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
584975|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
584976|NCT00555568|E3|Reported Event|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
584977|NCT00555568|E2|Reported Event|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
585437|NCT00554970|B5|Baseline|Total|Total of all reporting groups
584980|NCT00555477|B2|Baseline|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
584981|NCT00555477|B1|Baseline|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
584982|NCT00555477|P2|Participant Flow|Anastrozole Part 2|During the conduct of the trial the study was amended to change the eligibility criteria because of difficulties with the estradiol assay. Subjects enrolled after the amendment were required to sign consent and then have an average baseline estradiol concentration of ≤20 pg/ml in order to be considered eligible.
584983|NCT00555477|P1|Participant Flow|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH (Follicle-stimulating hormone) concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
584984|NCT00555477|O2|Outcome|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
584985|NCT00555477|O1|Outcome|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
584986|NCT00555477|E1|Reported Event|Anastrozole|anastrozole: 1 mg tablet by mouth once a day
584987|NCT00555464|B3|Baseline|Total|Total of all reporting groups
584988|NCT00555464|B2|Baseline|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
584989|NCT00555464|B1|Baseline|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
584990|NCT00555464|P2|Participant Flow|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
584991|NCT00555464|P1|Participant Flow|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
584992|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
584993|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
584994|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
585046|NCT00555321|P5|Participant Flow|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
584995|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
584996|NCT00555464|E2|Reported Event|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
584997|NCT00555464|E1|Reported Event|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
584998|NCT00555438|B1|Baseline|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
584999|NCT00555438|P1|Participant Flow|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
585000|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
585001|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
585002|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
585003|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
585004|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
585005|NCT00555438|E1|Reported Event|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
585006|NCT00555425|B3|Baseline|Total|Total of all reporting groups
585007|NCT00555425|B2|Baseline|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585008|NCT00555425|B1|Baseline|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585009|NCT00555425|P2|Participant Flow|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585010|NCT00555425|P1|Participant Flow|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585011|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585047|NCT00555321|P4|Participant Flow|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
589028|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
585012|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585013|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585014|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585015|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585016|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585017|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585018|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585019|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585020|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585048|NCT00555321|P3|Participant Flow|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585604|NCT00554229|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
585021|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585022|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585023|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585024|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585025|NCT00555425|E2|Reported Event|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
585026|NCT00555425|E1|Reported Event|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
585027|NCT00555360|B3|Baseline|Total|Total of all reporting groups
585028|NCT00555360|B2|Baseline|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
585029|NCT00555360|B1|Baseline|Standard mHealth|Weekly IVR calls for 12 months
585030|NCT00555360|P2|Participant Flow|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
585031|NCT00555360|P1|Participant Flow|Standard mHealth|Weekly IVR calls for 12 months
585032|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
585033|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
585034|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
585035|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
585036|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+CarePartner feedback
585037|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
585038|NCT00555360|E2|Reported Event|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
585039|NCT00555360|E1|Reported Event|Standard mHealth|Weekly IVR calls for 12 months
585040|NCT00555321|B6|Baseline|Total|Total of all reporting groups
585041|NCT00555321|B5|Baseline|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585042|NCT00555321|B4|Baseline|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585043|NCT00555321|B3|Baseline|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585044|NCT00555321|B2|Baseline|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585469|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
585049|NCT00555321|P2|Participant Flow|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585050|NCT00555321|P1|Participant Flow|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585051|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585052|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585053|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585054|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585055|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585056|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585057|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585058|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585059|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585060|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585061|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585062|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585063|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585064|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585065|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585066|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585067|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585068|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585069|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585091|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585605|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
585070|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585071|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585072|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585073|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585074|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585075|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585076|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585077|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585078|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585079|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585080|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585081|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585082|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585083|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585084|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585085|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585086|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585087|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585088|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585089|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585090|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585606|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
585092|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585093|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585094|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585095|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585096|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585097|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585098|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585099|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585100|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585101|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585102|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585103|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585104|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585105|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585106|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585107|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585108|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585109|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585110|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585111|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585112|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585544|NCT00554619|E1|Reported Event|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585607|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
585113|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585114|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585115|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585116|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585117|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585118|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585119|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585120|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585121|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585122|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585123|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585124|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585125|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585126|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585127|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585128|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585129|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585130|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585131|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585132|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585133|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585596|NCT00554294|P2|Participant Flow|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
585134|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585135|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585136|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585137|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585138|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585139|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585140|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585141|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585142|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585143|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585144|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585145|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585146|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585147|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585148|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585149|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585150|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585151|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585152|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585153|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585597|NCT00554294|P1|Participant Flow|Control Group|Schools did not receive any intervention.
585608|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
585154|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585155|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585156|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585157|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585158|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585159|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585160|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585161|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585162|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585163|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585164|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585165|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585166|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585167|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585168|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585169|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585170|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585171|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585172|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585173|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585598|NCT00554294|O2|Outcome|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
585174|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585175|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585176|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585177|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585178|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585179|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585180|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585181|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585182|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585183|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585184|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585185|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585186|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585187|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585188|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585189|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585190|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585191|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585192|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585193|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585599|NCT00554294|O1|Outcome|Control Group|Schools did not receive any intervention.
585600|NCT00554229|B3|Baseline|Total|Total of all reporting groups
585194|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585195|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585196|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585197|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585198|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585199|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585200|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585201|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
585202|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585203|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585204|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
585205|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
585206|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585207|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585208|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585209|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585210|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585211|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585212|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585213|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585214|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585215|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585216|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585217|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585218|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585219|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585220|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585221|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585222|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585223|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585224|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585225|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585226|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585227|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585228|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585229|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585230|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585231|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585232|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585233|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585234|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585235|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585236|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585237|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585238|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585239|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585240|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585241|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585242|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585243|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585244|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585245|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585246|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585247|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585248|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585249|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585250|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585251|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585252|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585253|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585254|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585255|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585256|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585257|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585258|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585259|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585260|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585261|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585262|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585263|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585264|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585265|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585266|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585267|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585268|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585269|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585270|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585271|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585272|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585273|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585274|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585275|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585276|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585277|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585278|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585279|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585302|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585280|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585281|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585282|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585283|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585284|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585285|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585286|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585287|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585288|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585289|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585290|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585291|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585292|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585293|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585294|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585295|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585296|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585297|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585298|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585299|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585300|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585301|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585303|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585304|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585305|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585306|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585307|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585308|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585309|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585310|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585311|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585312|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585313|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585314|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585315|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585316|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585317|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585318|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585319|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585320|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585321|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585322|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585323|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585394|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
585395|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
585324|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585325|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585326|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585327|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585328|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585329|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585330|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585331|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585332|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585333|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585334|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585335|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585336|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585337|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585338|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585339|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585340|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585341|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
585342|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585343|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
585344|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585396|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
585397|NCT00555061|E1|Reported Event|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
585345|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
585346|NCT00555321|E5|Reported Event|Tacrolimus + MMF|
585347|NCT00555321|E4|Reported Event|Tacrolimus|
585348|NCT00555321|E3|Reported Event|Belaticept (LI) + MMF|
585349|NCT00555321|E2|Reported Event|MI+MMF|
585350|NCT00555321|E1|Reported Event|Basiliximab+Belatacept (MI)+Mycophenolate Mofetil (MMF)|
585351|NCT00555217|B3|Baseline|Total|Total of all reporting groups
585352|NCT00555217|B2|Baseline|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
585353|NCT00555217|B1|Baseline|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
585354|NCT00555217|P2|Participant Flow|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
585355|NCT00555217|P1|Participant Flow|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
585356|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
585357|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
585358|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
585359|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
585360|NCT00555217|E2|Reported Event|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
585361|NCT00555217|E1|Reported Event|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
585362|NCT00555152|B5|Baseline|Total|Total of all reporting groups
585363|NCT00555152|B4|Baseline|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
585364|NCT00555152|B3|Baseline|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
585365|NCT00555152|B2|Baseline|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
585366|NCT00555152|B1|Baseline|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
585367|NCT00555152|P4|Participant Flow|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
585368|NCT00555152|P3|Participant Flow|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
585369|NCT00555152|P2|Participant Flow|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
585370|NCT00555152|P1|Participant Flow|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
585371|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
585372|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
585373|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
585374|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
585375|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
585376|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
585377|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
585378|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
585379|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
585380|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
585381|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
585382|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
585383|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
585384|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
585385|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
585386|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
585387|NCT00555152|E4|Reported Event|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
585388|NCT00555152|E3|Reported Event|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
585389|NCT00555152|E2|Reported Event|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
585390|NCT00555152|E1|Reported Event|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
585391|NCT00555061|B1|Baseline|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
585392|NCT00555061|P1|Participant Flow|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
585393|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
585398|NCT00555048|B1|Baseline|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585399|NCT00555048|P1|Participant Flow|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585400|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585401|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585402|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585403|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585404|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585405|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585406|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585407|NCT00555048|E1|Reported Event|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
585408|NCT00555009|B3|Baseline|Total|Total of all reporting groups
585409|NCT00555009|B2|Baseline|Placebo|Matching placebo injected SC.
585410|NCT00555009|B1|Baseline|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585411|NCT00555009|P2|Participant Flow|Placebo|Matching placebo injected SC.
585412|NCT00555009|P1|Participant Flow|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585413|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585414|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585415|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585416|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585417|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585418|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585419|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585420|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585421|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585422|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585423|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585424|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585425|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585426|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585427|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585428|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585429|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
585430|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585431|NCT00555009|E2|Reported Event|Placebo|Matching placebo injected SC.
585432|NCT00555009|E1|Reported Event|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
585433|NCT00554996|B1|Baseline|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
585434|NCT00554996|P1|Participant Flow|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
585601|NCT00554229|B2|Baseline|Placebo|Placebo oral tablet once daily
585438|NCT00554970|B4|Baseline|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
585439|NCT00554970|B3|Baseline|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
585440|NCT00554970|B2|Baseline|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
585441|NCT00554970|B1|Baseline|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
585442|NCT00554970|P4|Participant Flow|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
585443|NCT00554970|P3|Participant Flow|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
585444|NCT00554970|P2|Participant Flow|Treatment 2 Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
585445|NCT00554970|P1|Participant Flow|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
585446|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
585447|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
585448|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
585449|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
585450|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
585451|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
585452|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
585453|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
585454|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
585455|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
585456|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
585457|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
585458|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
585459|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
585460|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
585461|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
585462|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
585463|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
585464|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
585465|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
585466|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
585467|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
585468|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
585602|NCT00554229|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
585470|NCT00554970|E4|Reported Event|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
585471|NCT00554970|E3|Reported Event|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
585472|NCT00554970|E2|Reported Event|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
585473|NCT00554970|E1|Reported Event|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
585474|NCT00554853|B3|Baseline|Total|Total of all reporting groups
585475|NCT00554853|B2|Baseline|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to pioglitazone for 3 months, crossover after a 2 month washout.
585476|NCT00554853|B1|Baseline|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone for 3 months compared to placebo for 3 months,crossover after a 2 month washout.
585477|NCT00554853|P2|Participant Flow|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) for 3 months.
585478|NCT00554853|P1|Participant Flow|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone (study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
585479|NCT00554853|O2|Outcome|All Participants While on Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
585480|NCT00554853|O1|Outcome|All Participants While on Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
585481|NCT00554853|O2|Outcome|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
585482|NCT00554853|O1|Outcome|Study Drug (Pioglitazone) Then Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
585483|NCT00554853|E6|Reported Event|Placebo Then Study Drug (Piolglitazone) While on Study Drug|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
585484|NCT00554853|E5|Reported Event|Placebo Then Study Drug (Pioglitazone) During Washout|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
585485|NCT00554853|E4|Reported Event|Placebo Then Study Drug (Pioglitazone) While on Placebo|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
585486|NCT00554853|E3|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Placebo|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
585487|NCT00554853|E2|Reported Event|Study Drug (Pioglitazone) Then Placebo, During Washout|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
585488|NCT00554853|E1|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Drug|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
585489|NCT00554840|B3|Baseline|Total|Total of all reporting groups
585490|NCT00554840|B2|Baseline|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585491|NCT00554840|B1|Baseline|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585492|NCT00554840|P2|Participant Flow|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585493|NCT00554840|P1|Participant Flow|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585494|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585495|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585603|NCT00554229|P2|Participant Flow|Placebo|Placebo oral tablet once daily
585496|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585497|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585498|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585499|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585500|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585501|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
585502|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585503|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585504|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585505|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585506|NCT00554840|E2|Reported Event|Placebo|Subjects randomized to matching placebo will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585507|NCT00554840|E1|Reported Event|Varenicline|Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
585508|NCT00554801|B3|Baseline|Total|Total of all reporting groups
585509|NCT00554801|B2|Baseline|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
585510|NCT00554801|B1|Baseline|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
585511|NCT00554801|P2|Participant Flow|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
585512|NCT00554801|P1|Participant Flow|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
585513|NCT00554801|O2|Outcome|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
585514|NCT00554801|O1|Outcome|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
585515|NCT00554801|E2|Reported Event|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
585592|NCT00554372|E1|Reported Event|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585593|NCT00554294|B3|Baseline|Total|Total of all reporting groups
585516|NCT00554801|E1|Reported Event|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
585517|NCT00554749|B1|Baseline|Behavioral|All participants received identical behavioral treatment with no control group.
585518|NCT00554749|P1|Participant Flow|Behavioral|All participants received identical behavioral treatment with no control group.
585519|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
585520|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
585521|NCT00554749|E1|Reported Event|Behavioral|All participants received identical behavioral treatment with no control group.
585522|NCT00554671|B3|Baseline|Total|Total of all reporting groups
585523|NCT00554671|B2|Baseline|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
585524|NCT00554671|B1|Baseline|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
585525|NCT00554671|P2|Participant Flow|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
585526|NCT00554671|P1|Participant Flow|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
585527|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
585528|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
585529|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
585530|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
585531|NCT00554671|E2|Reported Event|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
585532|NCT00554671|E1|Reported Event|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
585533|NCT00554619|B1|Baseline|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585534|NCT00554619|P1|Participant Flow|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585535|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585536|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585537|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585538|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585539|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585540|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585541|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585542|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585543|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
585594|NCT00554294|B2|Baseline|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
585545|NCT00554515|B1|Baseline|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585546|NCT00554515|P1|Participant Flow|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585547|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585548|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585549|NCT00554515|O2|Outcome|CA-9 SNP Variant|Patient’s SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
585550|NCT00554515|O1|Outcome|CA-9 SNP Homozygous|Patient’s SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
585551|NCT00554515|O2|Outcome|Positive|
585552|NCT00554515|O1|Outcome|Negative|
585553|NCT00554515|O2|Outcome|PD-L1 Tumor Positive|
585554|NCT00554515|O1|Outcome|PD-L1 Tumor Negative|
585555|NCT00554515|O2|Outcome|Low CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient’s tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); Low is </=85% of CAIX positive tumor cells
585556|NCT00554515|O1|Outcome|High CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient’s tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); High is >85% of CAIX positive tumor cells.
585557|NCT00554515|O3|Outcome|Poor Clear Cell Histology Risk Group|
585558|NCT00554515|O2|Outcome|Intermediate Clear Cell Histology Risk Group|
585559|NCT00554515|O1|Outcome|Good Clear Cell Histology Risk Group|
585560|NCT00554515|O2|Outcome|Non-clear Cell Tumor Type|
585561|NCT00554515|O1|Outcome|Clear Cell Tumor Type|
585562|NCT00554515|O3|Outcome|High UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
585563|NCT00554515|O2|Outcome|Intermediate UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
585564|NCT00554515|O1|Outcome|Low UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
585565|NCT00554515|O3|Outcome|Poor MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
585566|NCT00554515|O2|Outcome|Intermediate MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
585567|NCT00554515|O1|Outcome|Favorable MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
585568|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585569|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585609|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
585570|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585571|NCT00554515|O1|Outcome|ISM Poor Risk Group|"ISM [Atkins et al CCR 2005]:~Poor predictive pathology OR the combination of intermediate predictive pathology and low CAIX staining~Pathology [Upton et al. J Immunother 2005] Poor predictive pathology: non-clear-cell histology OR some (>0%) papillary features OR no alveolar features OR >50% granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features~CAIX [Bui et al. CCR 2003] Low CAIX staining: </=85% of CAIX positive tumor cells"
585572|NCT00554515|O1|Outcome|ISM Good Risk Group|"ISM [Atkins et al CCR 2005]:~Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining~Pathology [Upton et al. J Immunother 2005] Good predictive pathology: clear-cell histology AND no papillary features AND >50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features~CAIX [Bui et al. CCR 2003] High CAIX staining: >85% of CAIX positive tumor cells"
585573|NCT00554515|E1|Reported Event|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
585574|NCT00554463|B1|Baseline|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
585575|NCT00554463|P1|Participant Flow|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
585576|NCT00554463|O1|Outcome|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
585577|NCT00554463|E1|Reported Event|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
585578|NCT00554372|B3|Baseline|Total|Total of all reporting groups
585579|NCT00554372|B2|Baseline|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585580|NCT00554372|B1|Baseline|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585581|NCT00554372|P2|Participant Flow|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585582|NCT00554372|P1|Participant Flow|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585583|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585584|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585585|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585586|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585587|NCT00554372|O2|Outcome|High Dose|"1e9 pfu (plaque-forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
585588|NCT00554372|O1|Outcome|Low Dose|"1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
585589|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585590|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585591|NCT00554372|E2|Reported Event|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
585623|NCT00554229|E2|Reported Event|Placebo|Placebo oral tablet once daily
585624|NCT00554229|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
585625|NCT00554216|B4|Baseline|Total|Total of all reporting groups
585626|NCT00554216|B3|Baseline|VI-0521 Top|PHEN/TPM 15/92
585627|NCT00554216|B2|Baseline|VI-0521 Low|PHEN/TPM 3.75/23
585628|NCT00554216|B1|Baseline|Placebo|
585629|NCT00554216|P3|Participant Flow|VI-0521 Top|PHEN/TPM 15 mg/92 mg
585630|NCT00554216|P2|Participant Flow|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
585631|NCT00554216|P1|Participant Flow|Placebo|
585632|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
585633|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
585634|NCT00554216|O1|Outcome|Placebo|
585635|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
585636|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
585637|NCT00554216|O1|Outcome|Placebo|
585638|NCT00554216|E3|Reported Event|VI-0521 Top|PHEN/TPM 15/92
585639|NCT00554216|E2|Reported Event|VI-0521 Low|PHEN/TPM 3.75/23
585640|NCT00554216|E1|Reported Event|Placebo|
585641|NCT00554190|B1|Baseline|AdvaCoat and Merogel Injectable|AdvaCoat compared with Merogel Injectable
585642|NCT00554190|P1|Participant Flow|AdvaCoat and Merogel|AdvaCoat compared to Merogel Injectable. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.
585643|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
585644|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
585645|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
585646|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
585647|NCT00554099|B4|Baseline|Total|Total of all reporting groups
585648|NCT00554099|B3|Baseline|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585649|NCT00554099|B2|Baseline|Mesalamine|400 mg mesalamine (6 tablets daily)
585650|NCT00554099|B1|Baseline|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585651|NCT00554099|P3|Participant Flow|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585652|NCT00554099|P2|Participant Flow|Mesalamine|400 mg mesalamine (6 tablets daily)
585653|NCT00554099|P1|Participant Flow|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585654|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585655|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585656|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585657|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585658|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585659|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585660|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585661|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585662|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585663|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585664|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585665|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585666|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585667|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585668|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585669|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585670|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585671|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585672|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585673|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585674|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585675|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585676|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
585677|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585678|NCT00554099|E3|Reported Event|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
585679|NCT00554099|E2|Reported Event|Mesalamine|400 mg mesalamine (6 tablets daily)
585680|NCT00554099|E1|Reported Event|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
585681|NCT00553969|B5|Baseline|Total|Total of all reporting groups
585682|NCT00553969|B4|Baseline|4 Placebo + Placebo|
585683|NCT00553969|B3|Baseline|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
585684|NCT00553969|B2|Baseline|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
585685|NCT00553969|B1|Baseline|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
585686|NCT00553969|P4|Participant Flow|4 Placebo + Placebo|
585687|NCT00553969|P3|Participant Flow|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
586221|NCT00552669|B1|Baseline|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
585688|NCT00553969|P2|Participant Flow|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
585689|NCT00553969|P1|Participant Flow|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
585690|NCT00553969|O4|Outcome|4 Placebo + Placebo|
585691|NCT00553969|O3|Outcome|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
585692|NCT00553969|O2|Outcome|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
585693|NCT00553969|O1|Outcome|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
585694|NCT00553969|E4|Reported Event|4 Placebo + Placebo|
585695|NCT00553969|E3|Reported Event|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
585696|NCT00553969|E2|Reported Event|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
585697|NCT00553969|E1|Reported Event|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
585698|NCT00553839|B1|Baseline|Ketamine|"Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given.~ketamine hydrochloride: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus."
585699|NCT00553839|P1|Participant Flow|Single Group Assignment|
585700|NCT00553839|O1|Outcome|Single Group Assignment|
585701|NCT00553839|O1|Outcome|Single Group Assignment|
585702|NCT00553839|O1|Outcome|Single Group Assignment|
585703|NCT00553839|E1|Reported Event|Single Group Assignment|
585704|NCT00553787|B4|Baseline|Total|Total of all reporting groups
585705|NCT00553787|B3|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
585706|NCT00553787|B2|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
585707|NCT00553787|B1|Baseline|Placebo|
585708|NCT00553787|P3|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
585709|NCT00553787|P2|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
585710|NCT00553787|P1|Participant Flow|Placebo|
585711|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
585712|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
585713|NCT00553787|O1|Outcome|Placebo|
585714|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
585715|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
585716|NCT00553787|O1|Outcome|Placebo|
585717|NCT00553787|E3|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
585718|NCT00553787|E2|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
585719|NCT00553787|E1|Reported Event|Placebo|
585720|NCT00553735|B1|Baseline|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585721|NCT00553735|P1|Participant Flow|All Study Participants|"Each eye of every participant was randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585722|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
585723|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585724|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
585725|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585929|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585726|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
585727|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585728|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
585729|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585730|NCT00553735|O2|Outcome|Artificial Tear|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Artificial Tear three times a day for 18 months."
585731|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585732|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
585733|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585734|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
585735|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585736|NCT00553735|E1|Reported Event|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
585737|NCT00553696|B5|Baseline|Total|Total of all reporting groups
585738|NCT00553696|B4|Baseline|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585739|NCT00553696|B3|Baseline|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585740|NCT00553696|B2|Baseline|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585741|NCT00553696|B1|Baseline|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585813|NCT00553605|B2|Baseline|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585742|NCT00553696|P4|Participant Flow|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585743|NCT00553696|P3|Participant Flow|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585744|NCT00553696|P2|Participant Flow|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585745|NCT00553696|P1|Participant Flow|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585746|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585747|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585748|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585749|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585750|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585751|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585752|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585753|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585754|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585755|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585756|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585757|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585758|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585759|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585760|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585761|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585762|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585763|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585764|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585765|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585766|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585767|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585768|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585814|NCT00553605|B1|Baseline|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585769|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585770|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585771|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585772|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
585773|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
585774|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
585775|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585776|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily regimen for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585777|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585778|NCT00553696|E4|Reported Event|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
585779|NCT00553696|E3|Reported Event|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585780|NCT00553696|E2|Reported Event|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
585781|NCT00553696|E1|Reported Event|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
585782|NCT00553644|B1|Baseline|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
585815|NCT00553605|P2|Participant Flow|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585783|NCT00553644|P1|Participant Flow|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
585784|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
585785|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
585786|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
585787|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
585788|NCT00553644|E1|Reported Event|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|lenalidomide: Given PO
585789|NCT00553631|B3|Baseline|Total|Total of all reporting groups
585790|NCT00553631|B2|Baseline|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585791|NCT00553631|B1|Baseline|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585792|NCT00553631|P2|Participant Flow|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585793|NCT00553631|P1|Participant Flow|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 unit per kilogram (U/kg) administered intravenously (IV) every other week for 39 weeks.
585794|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585795|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585796|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585797|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585798|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585799|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585800|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585801|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585802|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585803|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585804|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585805|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585806|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585807|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585808|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585809|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585810|NCT00553631|E2|Reported Event|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
585811|NCT00553631|E1|Reported Event|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
585812|NCT00553605|B3|Baseline|Total|Total of all reporting groups
585930|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585816|NCT00553605|P1|Participant Flow|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585817|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585818|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585819|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585820|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585821|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585822|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585823|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585824|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585825|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585826|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585827|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585828|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585829|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585830|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585831|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585832|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585833|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585834|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585835|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585836|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585837|NCT00553605|E2|Reported Event|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
585838|NCT00553605|E1|Reported Event|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
585839|NCT00553514|B6|Baseline|Total|Total of all reporting groups
585840|NCT00553514|B5|Baseline|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585841|NCT00553514|B4|Baseline|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585887|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
585842|NCT00553514|B3|Baseline|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585843|NCT00553514|B2|Baseline|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585844|NCT00553514|B1|Baseline|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585845|NCT00553514|P5|Participant Flow|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585846|NCT00553514|P4|Participant Flow|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585847|NCT00553514|P3|Participant Flow|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585848|NCT00553514|P2|Participant Flow|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585849|NCT00553514|P1|Participant Flow|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585850|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585851|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585852|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585928|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585853|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585854|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585855|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585856|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585857|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585858|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585859|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585860|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585861|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585862|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585863|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585888|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
585864|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585865|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585866|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585867|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585868|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585869|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585870|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585871|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585872|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585873|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585874|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
586141|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
585875|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585876|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585877|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585878|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585879|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585880|NCT00553514|E5|Reported Event|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585881|NCT00553514|E4|Reported Event|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585882|NCT00553514|E3|Reported Event|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585883|NCT00553514|E2|Reported Event|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585884|NCT00553514|E1|Reported Event|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
585885|NCT00553501|B1|Baseline|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
585886|NCT00553501|P1|Participant Flow|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
585926|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585927|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585889|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
585890|NCT00553501|E1|Reported Event|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
585891|NCT00553475|B4|Baseline|Total|Total of all reporting groups
585892|NCT00553475|B3|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585893|NCT00553475|B2|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585894|NCT00553475|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585895|NCT00553475|P3|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585896|NCT00553475|P2|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585897|NCT00553475|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585898|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585899|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585900|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585901|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585902|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585903|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585904|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585905|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585906|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585907|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585908|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585909|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585910|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585911|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585912|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585913|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585914|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585915|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585916|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585917|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585918|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585919|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585920|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585921|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585922|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585923|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585924|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585925|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
586142|NCT00553202|E1|Reported Event|Group 1|All patients
585931|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585932|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585933|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585934|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585935|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585936|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585937|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585938|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585939|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585940|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585941|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585942|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585943|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585944|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585945|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585946|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585947|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585948|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585949|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585950|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585951|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585952|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585953|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585954|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585955|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585956|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585957|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585958|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585959|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585960|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585961|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585962|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585963|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585964|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585965|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585966|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585967|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585968|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585969|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585970|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585971|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585972|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585973|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585974|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585975|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585976|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585977|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585978|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585979|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585980|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585981|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585982|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585983|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585984|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585985|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585986|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585987|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585988|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585989|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585990|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585991|NCT00553475|O3|Outcome|Expected Exposure Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr in the pregabalin 300 and 600 mg/day groups received pregabalin 300 mg/day and subjects with normal CLcr in the pregabalin 600 mg/day group received pregabalin 600 mg/day for 12 weeks.
585992|NCT00553475|O2|Outcome|Expected Exposure Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with normal CLcr in the pregabalin 300 mg/day group received pregabalin 300 mg/day for 12 weeks.
585993|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585994|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585995|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585996|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
585997|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
585998|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
585999|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
586000|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
586001|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
586002|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
586003|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
586004|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
586005|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
586006|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
586143|NCT00553150|B3|Baseline|Total|Total of all reporting groups
586007|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
586008|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
586009|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
586010|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
586011|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
586012|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
586013|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
586014|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
586015|NCT00553475|E3|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
586016|NCT00553475|E2|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
586017|NCT00553475|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
586018|NCT00553462|B1|Baseline|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
586019|NCT00553462|P1|Participant Flow|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
586020|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
586021|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
586022|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
586023|NCT00553462|E1|Reported Event|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
586024|NCT00553436|B1|Baseline|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
586025|NCT00553436|P1|Participant Flow|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
586026|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
586027|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
586028|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
586029|NCT00553436|E1|Reported Event|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
586030|NCT00553358|B4|Baseline|Total|Total of all reporting groups
586031|NCT00553358|B3|Baseline|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586032|NCT00553358|B2|Baseline|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586033|NCT00553358|B1|Baseline|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
586034|NCT00553358|P3|Participant Flow|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586200|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
586035|NCT00553358|P2|Participant Flow|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586036|NCT00553358|P1|Participant Flow|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
586037|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586038|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586039|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586040|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586041|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586042|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586043|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586044|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586045|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586046|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586047|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586048|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586049|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586050|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586051|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586052|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586053|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586054|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586055|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586056|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586057|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586058|NCT00553358|E3|Reported Event|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586059|NCT00553358|E2|Reported Event|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
586060|NCT00553358|E1|Reported Event|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
586061|NCT00553332|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586201|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586202|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
586062|NCT00553332|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586063|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586064|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586065|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586066|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586067|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586068|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586069|NCT00553332|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
586070|NCT00553319|B4|Baseline|Total|Total of all reporting groups
586071|NCT00553319|B3|Baseline|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
586072|NCT00553319|B2|Baseline|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
586073|NCT00553319|B1|Baseline|Placebo|"Placebo~Placebo: Placebo group"
586074|NCT00553319|P3|Participant Flow|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
586075|NCT00553319|P2|Participant Flow|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
586076|NCT00553319|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo group"
586077|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
586078|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
586079|NCT00553319|O1|Outcome|Placebo|"Placebo~Placebo: Placebo group"
586080|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
586081|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
586082|NCT00553319|O1|Outcome|Placebo|"Placebo~Placebo: Placebo group"
586083|NCT00553319|E3|Reported Event|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
586084|NCT00553319|E2|Reported Event|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
586085|NCT00553319|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo group"
586086|NCT00553280|B1|Baseline|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586087|NCT00553280|P1|Participant Flow|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586088|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586089|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586203|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586204|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
586205|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586206|NCT00552760|E2|Reported Event|Placebo|one tablet at bedtime for up to 6 months
586207|NCT00552760|E1|Reported Event|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586090|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586091|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586092|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586093|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586094|NCT00553280|E1|Reported Event|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
586095|NCT00553267|B4|Baseline|Total|Total of all reporting groups
586096|NCT00553267|B3|Baseline|Telmisartan 80mg and Amlodipine 10mg|
586097|NCT00553267|B2|Baseline|Telmisartan 40mg and Amlodipine 10mg|
586098|NCT00553267|B1|Baseline|Amlodipine 10mg|
586099|NCT00553267|P3|Participant Flow|Telmisartan 80mg and Amlodipine 10mg|
586100|NCT00553267|P2|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|
586101|NCT00553267|P1|Participant Flow|Amlodipine 10mg|
586102|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586103|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586104|NCT00553267|O1|Outcome|Amlodipine 10mg|
586105|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586106|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586107|NCT00553267|O1|Outcome|Amlodipine 10mg|
586108|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586109|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586110|NCT00553267|O1|Outcome|Amlodipine 10mg|
586111|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586112|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586113|NCT00553267|O1|Outcome|Amlodipine 10mg|
586114|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586115|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586116|NCT00553267|O1|Outcome|Amlodipine 10mg|
586117|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586118|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586119|NCT00553267|O1|Outcome|Amlodipine 10mg|
586120|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586121|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586122|NCT00553267|O1|Outcome|Amlodipine 10mg|
586123|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586124|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586125|NCT00553267|O1|Outcome|Amlodipine 10mg|
586126|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586127|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586128|NCT00553267|O1|Outcome|Amlodipine 10mg|
586129|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
586130|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
586131|NCT00553267|O1|Outcome|Amlodipine 10mg|
586132|NCT00553267|E3|Reported Event|Telmisartan 80mg and Amlodipine 10mg|
586133|NCT00553267|E2|Reported Event|Telmisartan 40mg and Amlodipine 10mg|
586134|NCT00553267|E1|Reported Event|Amlodipine 10mg|
586135|NCT00553202|B1|Baseline|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
586136|NCT00553202|P1|Participant Flow|Treatment (Chemotherapy and Allogeneic SCT)|All patients
586137|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
586138|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
586139|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
586140|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
586144|NCT00553150|B2|Baseline|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586145|NCT00553150|B1|Baseline|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586146|NCT00553150|P4|Participant Flow|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586147|NCT00553150|P3|Participant Flow|Phase 1: Cohort/Dose Level 3 (70 mg RAD001)|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586148|NCT00553150|P2|Participant Flow|Phase I: Cohort/Dose Level 2 (50 mg RAD001)|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586149|NCT00553150|P1|Participant Flow|Phase I: Cohort/Dose Level 1 (30 mg RAD001)|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586150|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586151|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586152|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586153|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586154|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586155|NCT00553150|O3|Outcome|Phase I: Dose Level 2|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586156|NCT00553150|O2|Outcome|Phase I: Dose Level 1|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586157|NCT00553150|O1|Outcome|Phase I: Dose Level 0|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586158|NCT00553150|E2|Reported Event|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586159|NCT00553150|E1|Reported Event|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
586160|NCT00553098|B1|Baseline|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586161|NCT00553098|P1|Participant Flow|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586162|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586163|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586208|NCT00552695|B3|Baseline|Total|Total of all reporting groups
586209|NCT00552695|B2|Baseline|Control Patch|Warm patch with no active substances
586210|NCT00552695|B1|Baseline|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
586211|NCT00552695|P2|Participant Flow|Control Patch|Warm patch with no active substances
586212|NCT00552695|P1|Participant Flow|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
586213|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
586214|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
586215|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
586216|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
586164|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586165|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586166|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic Ste"
586167|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic"
586168|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586169|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic S"
586170|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic S"
586217|NCT00552695|E2|Reported Event|Control Patch|Warm patch with no active substances
586218|NCT00552695|E1|Reported Event|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
586219|NCT00552669|B3|Baseline|Total|Total of all reporting groups
586220|NCT00552669|B2|Baseline|Drug Eluting Stents|Any Drug Eluting Stents
586171|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586172|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586173|NCT00553098|E1|Reported Event|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV~Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
586174|NCT00552812|B1|Baseline|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
586175|NCT00552812|P1|Participant Flow|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
586176|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
586177|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
586178|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
586179|NCT00552812|E1|Reported Event|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
586180|NCT00552786|B3|Baseline|Total|Total of all reporting groups
586181|NCT00552786|B2|Baseline|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
586182|NCT00552786|B1|Baseline|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
586183|NCT00552786|P2|Participant Flow|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
586184|NCT00552786|P1|Participant Flow|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
586185|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
586186|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
586187|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
586188|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
586189|NCT00552786|E2|Reported Event|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
586190|NCT00552786|E1|Reported Event|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
586191|NCT00552760|B3|Baseline|Total|Total of all reporting groups
586192|NCT00552760|B2|Baseline|Placebo|one tablet at bedtime for up to 6 months
586193|NCT00552760|B1|Baseline|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586194|NCT00552760|P2|Participant Flow|Placebo|one tablet at bedtime for up to 6 months
586195|NCT00552760|P1|Participant Flow|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586196|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
586197|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586198|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
586199|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
586222|NCT00552669|P2|Participant Flow|Drug Eluting Stents|Any Drug Eluting Stents
586223|NCT00552669|P1|Participant Flow|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
586224|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
586225|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
586226|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
586227|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
586228|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
586229|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
586230|NCT00552669|E2|Reported Event|Drug Eluting Stents|Any Drug Eluting Stents
586231|NCT00552669|E1|Reported Event|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
586232|NCT00552578|B3|Baseline|Total|Total of all reporting groups
586233|NCT00552578|B2|Baseline|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
586234|NCT00552578|B1|Baseline|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
586235|NCT00552578|P2|Participant Flow|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
586236|NCT00552578|P1|Participant Flow|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
586237|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
586238|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
586239|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
586240|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
586241|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
586242|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
586243|NCT00552578|E2|Reported Event|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
586244|NCT00552578|E1|Reported Event|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
586245|NCT00552513|B3|Baseline|Total|Total of all reporting groups
586246|NCT00552513|B2|Baseline|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
586247|NCT00552513|B1|Baseline|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
586248|NCT00552513|P2|Participant Flow|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
586249|NCT00552513|P1|Participant Flow|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
586250|NCT00552513|O2|Outcome|Delayed Intervention|
586251|NCT00552513|O1|Outcome|Early Intervention|
586252|NCT00552513|O2|Outcome|Delayed Intervention|
586253|NCT00552513|O1|Outcome|Early Intervention|
586254|NCT00552513|O2|Outcome|Delayed Intervention|Coronary angiography to be performed after a minimum delay of 36 hours after randomization
586255|NCT00552513|O1|Outcome|Early Intervention|Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
586256|NCT00552513|E2|Reported Event|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
586257|NCT00552513|E1|Reported Event|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
586258|NCT00552448|B3|Baseline|Total|Total of all reporting groups
586259|NCT00552448|B2|Baseline|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
586260|NCT00552448|B1|Baseline|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
586261|NCT00552448|P2|Participant Flow|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
586262|NCT00552448|P1|Participant Flow|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
586263|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
586264|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
586379|NCT00552279|E1|Reported Event|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586265|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
586266|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
586267|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
586268|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
586269|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
586270|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
586271|NCT00552448|E2|Reported Event|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
586272|NCT00552448|E1|Reported Event|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
586273|NCT00552422|B1|Baseline|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
586274|NCT00552422|P1|Participant Flow|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
586275|NCT00552422|O1|Outcome|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
586276|NCT00552422|E1|Reported Event|Domperidone|Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
586277|NCT00552409|B3|Baseline|Total|Total of all reporting groups
586278|NCT00552409|B2|Baseline|Placebo|One softgel daily for one year
586279|NCT00552409|B1|Baseline|Cholecalciferol|2000 IU by mouth daily for one year
586280|NCT00552409|P2|Participant Flow|Placebo|One softgel daily for one year
586281|NCT00552409|P1|Participant Flow|Cholecalciferol|2000 IU by mouth daily for one year
586282|NCT00552409|O2|Outcome|Placebo|One softgel daily for one year
586283|NCT00552409|O1|Outcome|Cholecalciferol|2000 IU by mouth daily for one year
586284|NCT00552409|E2|Reported Event|Placebo|One softgel daily for one year
586285|NCT00552409|E1|Reported Event|Cholecalciferol|2000 IU by mouth daily for one year
586286|NCT00552396|B8|Baseline|Total|Total of all reporting groups
586287|NCT00552396|B7|Baseline|3 mg/kg|
586288|NCT00552396|B6|Baseline|1 mg/kg|
586289|NCT00552396|B5|Baseline|0.3 mg/kg|
586290|NCT00552396|B4|Baseline|0.075 mg/kg|
586291|NCT00552396|B3|Baseline|0.015 mg/kg|
586292|NCT00552396|B2|Baseline|0.003 mg/kg|
586293|NCT00552396|B1|Baseline|0.0003 mg/kg|
586294|NCT00552396|P7|Participant Flow|3 mg/kg|
586295|NCT00552396|P6|Participant Flow|1 mg/kg|
586296|NCT00552396|P5|Participant Flow|0.3 mg/kg|
586297|NCT00552396|P4|Participant Flow|0.075 mg/kg|
586298|NCT00552396|P3|Participant Flow|0.015 mg/kg|
586299|NCT00552396|P2|Participant Flow|0.003 mg/kg|
586300|NCT00552396|P1|Participant Flow|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
586301|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
586302|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
586303|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
586304|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
586380|NCT00552240|B3|Baseline|Total|Total of all reporting groups
586381|NCT00552240|B2|Baseline|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586305|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
586306|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
586307|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
586308|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
586309|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
586310|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|IV 1 hour infusion
586311|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
586312|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV bolus injection
586313|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV bolus injection
586314|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV bolus injection
586315|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
586316|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
586317|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|IV 1 hour infusion
586318|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
586319|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV Bolus
586320|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV Bolus
586321|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV Bolus
586322|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Participants were administered an IV dose of 3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level.If MTD this is not reached at 3mg/kg, 7 subjects will be enrolled at this dose to obtain more data from a larger subject pool to better evaluate safety, PK, PD and signs of efficacy.
586323|NCT00552396|O6|Outcome|IPH2101 1mg/kg|Participants were administered an IV dose of 1 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
586324|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|Participants were administered an IV dose of 0.3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
586325|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Participants were administered an IV dose of 0.075 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
586326|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Participants were administered an IV dose of 0.015 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
586327|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Participants were administered an IV dose of 0.003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
586328|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Participants were administered an IV dose of 0.0003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
586329|NCT00552396|E7|Reported Event|3 mg/kg|
586330|NCT00552396|E6|Reported Event|1 mg/kg|
586331|NCT00552396|E5|Reported Event|0.3 mg/kg|
586332|NCT00552396|E4|Reported Event|0.075 mg/kg|
586333|NCT00552396|E3|Reported Event|0.015 mg/kg|
586334|NCT00552396|E2|Reported Event|0.003 mg/kg|
586335|NCT00552396|E1|Reported Event|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
586336|NCT00552344|B1|Baseline|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
586337|NCT00552344|P1|Participant Flow|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
586338|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
586339|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
586340|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.~The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
586341|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.~The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
586342|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
586343|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
586344|NCT00552344|E1|Reported Event|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
586345|NCT00552305|B1|Baseline|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586346|NCT00552305|P1|Participant Flow|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586347|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586348|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586349|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586350|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586351|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586352|NCT00552305|E1|Reported Event|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
586353|NCT00552279|B3|Baseline|Total|Total of all reporting groups
586354|NCT00552279|B2|Baseline|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586355|NCT00552279|B1|Baseline|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586356|NCT00552279|P2|Participant Flow|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586357|NCT00552279|P1|Participant Flow|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586358|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586359|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586360|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586361|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586362|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586363|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586364|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586365|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586366|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586367|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586368|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586369|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586370|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586371|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586372|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586373|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586374|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586375|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586376|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
586377|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
586378|NCT00552279|E2|Reported Event|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
589029|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
586382|NCT00552240|B1|Baseline|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586383|NCT00552240|P2|Participant Flow|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586384|NCT00552240|P1|Participant Flow|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586385|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586386|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586387|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586388|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586389|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586390|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586391|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586392|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586393|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586394|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586395|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586396|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586397|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586398|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586399|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586400|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586401|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586402|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586403|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586404|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586405|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586406|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586407|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586408|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586409|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586410|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586411|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586412|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586413|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586414|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586415|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586416|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586417|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586418|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586419|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586420|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586421|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586422|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586423|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586424|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586425|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586426|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586427|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586428|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586429|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586430|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586431|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586432|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586433|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586434|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586435|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586436|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586437|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586438|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586439|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586440|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586441|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586442|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586443|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586444|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586445|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586446|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586447|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586448|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586449|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586450|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586451|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586452|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586453|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586454|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586455|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586456|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586457|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586458|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586459|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586460|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586461|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586462|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586463|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586464|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586465|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586466|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586467|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586468|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586469|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586470|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586471|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586472|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586473|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586474|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586475|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586476|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586477|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586478|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586479|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586480|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586481|NCT00552240|E2|Reported Event|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
586482|NCT00552240|E1|Reported Event|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
586483|NCT00552188|B3|Baseline|Total|Total of all reporting groups
586484|NCT00552188|B2|Baseline|Placebo|Matching placebo
586485|NCT00552188|B1|Baseline|VIA-2291|VIA-2291 100mg
586486|NCT00552188|P2|Participant Flow|Placebo|Matching placebo
586487|NCT00552188|P1|Participant Flow|VIA-2291|VIA-2291 100mg
586488|NCT00552188|O2|Outcome|Placebo|Matching placebo
586489|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
586490|NCT00552188|O2|Outcome|Placebo|Matching placebo
586491|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
586492|NCT00552188|E2|Reported Event|Placebo|Matching placebo
586493|NCT00552188|E1|Reported Event|VIA-2291|VIA-2291 100mg
586494|NCT00552175|B4|Baseline|Total|Total of all reporting groups
586495|NCT00552175|B3|Baseline|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586496|NCT00552175|B2|Baseline|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586497|NCT00552175|B1|Baseline|Placebo|placebo comparator taken orally every day
586498|NCT00552175|P3|Participant Flow|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
589030|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
586499|NCT00552175|P2|Participant Flow|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586500|NCT00552175|P1|Participant Flow|Placebo|placebo comparator taken orally every day
586501|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586502|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586503|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586504|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
586505|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586506|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586507|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586508|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586509|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
586510|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586511|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586512|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586513|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586514|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
586515|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586516|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586517|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586518|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586519|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
586520|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586521|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586522|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586523|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586524|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
586525|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586526|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586527|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586528|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586529|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
586530|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
586531|NCT00552175|E3|Reported Event|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
586532|NCT00552175|E2|Reported Event|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
586533|NCT00552175|E1|Reported Event|Placebo|placebo comparator taken orally every day
586534|NCT00552110|B6|Baseline|Total|Total of all reporting groups
586535|NCT00552110|B5|Baseline|Placebo|Placebo nasal spray
586536|NCT00552110|B4|Baseline|Oxymetazoline|OXY twice daily
586537|NCT00552110|B3|Baseline|Mometasone|MFNS once daily
586538|NCT00552110|B2|Baseline|Combination3|MFNS with OXY 3 sprays once daily
586539|NCT00552110|B1|Baseline|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
586540|NCT00552110|P5|Participant Flow|Placebo|Placebo nasal spray
586541|NCT00552110|P4|Participant Flow|Oxymetazoline|OXY twice daily
586542|NCT00552110|P3|Participant Flow|Mometasone|MFNS once daily
586543|NCT00552110|P2|Participant Flow|Combination3|MFNS with OXY 3 sprays once daily
586544|NCT00552110|P1|Participant Flow|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
586545|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
586546|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
586547|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
586548|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
586549|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
586550|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
586551|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
586552|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
586553|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
586554|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
586555|NCT00552110|E5|Reported Event|Placebo|Placebo nasal spray
586556|NCT00552110|E4|Reported Event|Oxymetazoline|OXY twice daily
586557|NCT00552110|E3|Reported Event|Mometasone|MFNS once daily
586558|NCT00552110|E2|Reported Event|Combination3|MFNS with OXY 3 sprays once daily
586559|NCT00552110|E1|Reported Event|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
586560|NCT00552084|B3|Baseline|Total|Total of all reporting groups
586561|NCT00552084|B2|Baseline|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
586562|NCT00552084|B1|Baseline|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
586563|NCT00552084|P2|Participant Flow|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
586564|NCT00552084|P1|Participant Flow|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
586565|NCT00552084|O2|Outcome|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
586566|NCT00552084|O1|Outcome|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
586567|NCT00552084|E2|Reported Event|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
586568|NCT00552084|E1|Reported Event|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
586569|NCT00552058|B3|Baseline|Total|Total of all reporting groups
586570|NCT00552058|B2|Baseline|Placebo|Placebo, saline solution for sc injection
586571|NCT00552058|B1|Baseline|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586572|NCT00552058|P2|Participant Flow|Placebo|Placebo, saline solution for sc injection
586573|NCT00552058|P1|Participant Flow|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586574|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586575|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586576|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586577|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586578|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586579|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586580|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586581|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586582|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586583|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586584|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586585|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586586|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586587|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586588|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586589|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586590|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586591|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586592|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586593|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586594|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586595|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586596|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586597|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586598|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586599|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586600|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586601|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586602|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586603|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586604|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586605|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586606|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
586607|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586608|NCT00552058|E2|Reported Event|Placebo|Placebo, saline solution for sc injection
586609|NCT00552058|E1|Reported Event|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
586610|NCT00552032|B3|Baseline|Total|Total of all reporting groups
586611|NCT00552032|B2|Baseline|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586612|NCT00552032|B1|Baseline|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586613|NCT00552032|P2|Participant Flow|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586614|NCT00552032|P1|Participant Flow|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586615|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586616|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586617|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586618|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586619|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586620|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586621|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586622|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586623|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586624|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586625|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586626|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586627|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586628|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586629|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586630|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586631|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586632|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586633|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586634|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586635|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586636|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586637|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586638|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586639|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586640|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586641|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586642|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586643|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586644|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586645|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586646|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586647|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586678|NCT00551707|P3|Participant Flow|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
586648|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586649|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586650|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586651|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586652|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586653|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586654|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586655|NCT00552032|E2|Reported Event|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586656|NCT00552032|E1|Reported Event|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
586657|NCT00551759|B1|Baseline|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
586658|NCT00551759|P1|Participant Flow|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
586659|NCT00551759|O1|Outcome|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
586660|NCT00551759|E1|Reported Event|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab.
586661|NCT00551746|B3|Baseline|Total|Total of all reporting groups
586662|NCT00551746|B2|Baseline|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
586663|NCT00551746|B1|Baseline|Grape Juice|100% Grape Juice
586664|NCT00551746|P2|Participant Flow|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
586665|NCT00551746|P1|Participant Flow|Grape Juice|100% Grape Juice
586666|NCT00551746|O2|Outcome|Placebo|Taste, color, and colorically matched grape juice placebo
586667|NCT00551746|O1|Outcome|Purple Grape Juice|100% grape juice
586668|NCT00551746|E2|Reported Event|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
586669|NCT00551746|E1|Reported Event|Grape Juice|100% Grape Juice
586670|NCT00551707|B6|Baseline|Total|Total of all reporting groups
586671|NCT00551707|B5|Baseline|Placebo|"placebo~placebo: placebo"
586672|NCT00551707|B4|Baseline|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
586673|NCT00551707|B3|Baseline|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
586674|NCT00551707|B2|Baseline|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
586675|NCT00551707|B1|Baseline|CRx-102 (2.7/180)|Crx-102 (Dose 1) 2.7 mg prednisolone plus 180 mg dipyridamole
586676|NCT00551707|P5|Participant Flow|Placebo|"placebo~placebo: placebo"
586677|NCT00551707|P4|Participant Flow|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
586679|NCT00551707|P2|Participant Flow|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
586680|NCT00551707|P1|Participant Flow|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
586681|NCT00551707|O5|Outcome|Placebo|"placebo~placebo: placebo"
586682|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole 360 mg"
586683|NCT00551707|O3|Outcome|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
586684|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
586685|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|"Crx-102 (Dose 1)~2.7 mg prednisolone plus 180 mg dipyridamole"
586686|NCT00551707|O5|Outcome|Placebo|"placebo~placebo: placebo"
586687|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
586688|NCT00551707|O3|Outcome|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
586689|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
586690|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
586691|NCT00551707|E5|Reported Event|Placebo|"placebo~placebo: placebo"
586692|NCT00551707|E4|Reported Event|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
586693|NCT00551707|E3|Reported Event|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
586694|NCT00551707|E2|Reported Event|CRx-102 (Dose 2)|"Crx-102 (Dose 2)~CRx-102: prednisolone + dipyridamole"
586695|NCT00551707|E1|Reported Event|CRx-102 (Dose 1)|"Crx-102 (Dose 1)~CRx-102: prednisolone + dipyridamole"
586696|NCT00551642|B3|Baseline|Total|Total of all reporting groups
586697|NCT00551642|B2|Baseline|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
586698|NCT00551642|B1|Baseline|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
586699|NCT00551642|P2|Participant Flow|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
586700|NCT00551642|P1|Participant Flow|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
586701|NCT00551642|O2|Outcome|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
586702|NCT00551642|O1|Outcome|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
586703|NCT00551642|E2|Reported Event|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
586704|NCT00551642|E1|Reported Event|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
586705|NCT00551525|B1|Baseline|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586706|NCT00551525|P1|Participant Flow|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586707|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586708|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586709|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586710|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586711|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586712|NCT00551525|O1|Outcome|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586713|NCT00551525|E1|Reported Event|Radiotherapy + Samarium 153|Samarium 153 infusion followed by radiotherapy 12 weeks later
586714|NCT00551460|B1|Baseline|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
586715|NCT00551460|P1|Participant Flow|ATRA + GO + Arsenic|"Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR~Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest~Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3~Consolidation 5 and 6: GO 9mg/m2 IV D1~Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year"
586716|NCT00551460|O1|Outcome|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
586717|NCT00551460|O1|Outcome|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
586734|NCT00551369|E1|Reported Event|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586967|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586718|NCT00551460|O1|Outcome|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
586719|NCT00551460|E1|Reported Event|ATRA + GO + Arsenic|Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR
586720|NCT00551421|B1|Baseline|Pertuzumab and Cetuximab|Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
586721|NCT00551421|P1|Participant Flow|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
586722|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
586723|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
586724|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
586725|NCT00551421|O1|Outcome|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
586726|NCT00551421|E1|Reported Event|Pertuzumab and Cetuximab|"Original Protocol: Patients received pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose on cycle 1, day 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as the Original Protocol (see above) except the Cetuximab loading dose was no longer given on cycle 1, day 2 (maintainance dose given).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: pertuzumab, cetuximab, irinotecan hydrochloride~Corrlateive studies: immunohistochemistry staining method, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis"
586727|NCT00551369|B1|Baseline|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586728|NCT00551369|P1|Participant Flow|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586729|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586730|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586731|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586732|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586733|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
586735|NCT00551291|B1|Baseline|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
586736|NCT00551291|P1|Participant Flow|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
586737|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
586738|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
586739|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
586740|NCT00551291|E1|Reported Event|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
586741|NCT00551213|B3|Baseline|Total|Total of all reporting groups
586742|NCT00551213|B2|Baseline|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586743|NCT00551213|B1|Baseline|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586744|NCT00551213|P2|Participant Flow|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586745|NCT00551213|P1|Participant Flow|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586746|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586747|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586748|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586749|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586750|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586751|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586752|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586753|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586754|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586755|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586756|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586757|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586758|NCT00551213|E2|Reported Event|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586759|NCT00551213|E1|Reported Event|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
586760|NCT00551200|B1|Baseline|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
586761|NCT00551200|P1|Participant Flow|Buphenyl to HPN-100|HPN-100 : Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study, and then switched over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 was increased and the dose of Buphenyl® was decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate was HPN-100. Target HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week and then switched back to previous dose of Buphenyl for the last week of the study.
586762|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
586763|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
586764|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrates as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
586765|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
586766|NCT00551200|O1|Outcome|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
586767|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
586768|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
586769|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
586770|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
586771|NCT00551200|E2|Reported Event|HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
586772|NCT00551200|E1|Reported Event|Buphenyl|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
586773|NCT00551174|B3|Baseline|Total|Total of all reporting groups
586774|NCT00551174|B2|Baseline|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
586775|NCT00551174|B1|Baseline|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
586776|NCT00551174|P2|Participant Flow|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
586777|NCT00551174|P1|Participant Flow|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
586778|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
586779|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
586780|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
586781|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
586782|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
586783|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
586784|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
586785|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
586786|NCT00551174|E2|Reported Event|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
586787|NCT00551174|E1|Reported Event|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
586788|NCT00551161|B1|Baseline|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
586789|NCT00551161|P1|Participant Flow|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
586790|NCT00551161|O1|Outcome|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
586791|NCT00551161|E1|Reported Event|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
586792|NCT00551135|B5|Baseline|Total|Total of all reporting groups
586793|NCT00551135|B4|Baseline|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586794|NCT00551135|B3|Baseline|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586795|NCT00551135|B2|Baseline|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586796|NCT00551135|B1|Baseline|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586797|NCT00551135|P4|Participant Flow|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586798|NCT00551135|P3|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586799|NCT00551135|P2|Participant Flow|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586925|NCT00551031|B4|Baseline|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
586800|NCT00551135|P1|Participant Flow|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586801|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586802|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586803|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586804|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586805|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586806|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586807|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586808|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586809|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586810|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586811|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586812|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586813|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586814|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586815|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586816|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586817|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586818|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586819|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586820|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586821|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586822|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586823|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586824|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586825|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586826|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586827|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586828|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586829|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586830|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586831|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586832|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586833|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586834|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586835|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586836|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586837|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586838|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586839|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586840|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586841|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586842|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586843|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586844|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586845|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586846|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586847|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586848|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586849|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586850|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586851|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586852|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586853|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586854|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586855|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586856|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586857|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586858|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586859|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586860|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586861|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586862|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586863|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586864|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586865|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586866|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586867|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586868|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586869|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586870|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586871|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586872|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586873|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586874|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586875|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586876|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586877|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586878|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586879|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586880|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586881|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586882|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586883|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586884|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586885|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586886|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586887|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586888|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586889|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586890|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586891|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586892|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586893|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586894|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586895|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586896|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586897|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586898|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586899|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586900|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586901|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586902|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586903|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586904|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586905|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586906|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586907|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586908|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586909|NCT00551135|E4|Reported Event|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
586910|NCT00551135|E3|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
586911|NCT00551135|E2|Reported Event|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
586912|NCT00551135|E1|Reported Event|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
586913|NCT00551070|B1|Baseline|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586914|NCT00551070|P1|Participant Flow|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586915|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586916|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586917|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586918|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586919|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586920|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586921|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586922|NCT00551070|E1|Reported Event|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
586923|NCT00551031|B6|Baseline|Total|Total of all reporting groups
586924|NCT00551031|B5|Baseline|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
589031|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
586926|NCT00551031|B3|Baseline|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586927|NCT00551031|B2|Baseline|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586928|NCT00551031|B1|Baseline|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586929|NCT00551031|P5|Participant Flow|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586930|NCT00551031|P4|Participant Flow|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
586931|NCT00551031|P3|Participant Flow|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586932|NCT00551031|P2|Participant Flow|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586933|NCT00551031|P1|Participant Flow|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586934|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586935|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
586936|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586937|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586938|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586939|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586940|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
586941|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586942|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586943|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586944|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586945|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
586946|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586947|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586948|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586949|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586950|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
586951|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586952|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586953|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586954|NCT00551031|E5|Reported Event|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586955|NCT00551031|E4|Reported Event|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
586956|NCT00551031|E3|Reported Event|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
586957|NCT00551031|E2|Reported Event|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586958|NCT00551031|E1|Reported Event|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
586959|NCT00550953|B3|Baseline|Total|Total of all reporting groups
586960|NCT00550953|B2|Baseline|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586961|NCT00550953|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586962|NCT00550953|P2|Participant Flow|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586963|NCT00550953|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586964|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586965|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586966|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586968|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586969|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586970|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586971|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586972|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586973|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586974|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586975|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586976|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586977|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586978|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586979|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586980|NCT00550953|E2|Reported Event|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
586981|NCT00550953|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
586982|NCT00550862|B5|Baseline|Total|Total of all reporting groups
586983|NCT00550862|B4|Baseline|Placebo|
586984|NCT00550862|B3|Baseline|INT-747 50 mg|
586985|NCT00550862|B2|Baseline|INT-747 25 mg|
586986|NCT00550862|B1|Baseline|INT-747 10 mg|
586987|NCT00550862|P4|Participant Flow|Placebo|
586988|NCT00550862|P3|Participant Flow|INT-747 50 mg|
586989|NCT00550862|P2|Participant Flow|INT-747 25 mg|
586990|NCT00550862|P1|Participant Flow|INT-747 10 mg|
586991|NCT00550862|O4|Outcome|Placebo|
586992|NCT00550862|O3|Outcome|INT-747 50 mg|
586993|NCT00550862|O2|Outcome|INT-747 25 mg|
586994|NCT00550862|O1|Outcome|INT-747 10 mg|
586995|NCT00550862|O4|Outcome|Placebo|
586996|NCT00550862|O3|Outcome|INT-747 50 mg|
586997|NCT00550862|O2|Outcome|INT-747 25 mg|
586998|NCT00550862|O1|Outcome|INT-747 10 mg|
586999|NCT00550862|O4|Outcome|Placebo|
587000|NCT00550862|O3|Outcome|INT-747 50 mg|
587001|NCT00550862|O2|Outcome|INT-747 25 mg|
587002|NCT00550862|O1|Outcome|INT-747 10 mg|
587003|NCT00550862|E4|Reported Event|Placebo|
587004|NCT00550862|E3|Reported Event|INT-747 50 mg|
587005|NCT00550862|E2|Reported Event|INT-747 25 mg|
587006|NCT00550862|E1|Reported Event|INT-747 10 mg|
587007|NCT00550836|B3|Baseline|Total|Total of all reporting groups
587008|NCT00550836|B2|Baseline|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587009|NCT00550836|B1|Baseline|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587010|NCT00550836|P2|Participant Flow|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587011|NCT00550836|P1|Participant Flow|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587012|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587025|NCT00550771|B2|Baseline|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
587131|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587013|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587014|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587015|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587016|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587017|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587018|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587019|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587020|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587021|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587022|NCT00550836|E2|Reported Event|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
587023|NCT00550836|E1|Reported Event|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
587024|NCT00550771|B3|Baseline|Total|Total of all reporting groups
587053|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587026|NCT00550771|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
587027|NCT00550771|P2|Participant Flow|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
587028|NCT00550771|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
587029|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
587030|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
587031|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
587032|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
587033|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
587034|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
587035|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
587036|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
587037|NCT00550771|E2|Reported Event|Doxorubicin Based Regimen|
587038|NCT00550771|E1|Reported Event|PLD Based Regimen|
587039|NCT00550745|B3|Baseline|Total|Total of all reporting groups
587040|NCT00550745|B2|Baseline|Placebo|"Represents the number of subjects according to the treatment (placebo) received.~Excludes subjects who were not vaccinated."
587041|NCT00550745|B1|Baseline|ZOSTAVAX™|"Represents the number of subjects according to the treatment (ZOSTAVAX™) received.~Excludes subjects who were not vaccinated."
587042|NCT00550745|P2|Participant Flow|Placebo|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
587043|NCT00550745|P1|Participant Flow|ZOSTAVAX™|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
587044|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
587045|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
587046|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
587047|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
587048|NCT00550745|E2|Reported Event|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
587049|NCT00550745|E1|Reported Event|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (Zostavax™) and had safety follow-up.
587050|NCT00550732|B1|Baseline|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587051|NCT00550732|P1|Participant Flow|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587052|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587127|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587054|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587055|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587056|NCT00550732|O1|Outcome|Prosaconazole|Posaconazole oral suspension was administered as 400 mg BID with food or 200 mg QID without food for a minimum of one month.
587057|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587058|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587059|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587060|NCT00550732|E1|Reported Event|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
587061|NCT00550680|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587062|NCT00550680|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
587063|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587064|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587065|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587066|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587067|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587068|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587069|NCT00550680|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
587070|NCT00550654|B1|Baseline|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587071|NCT00550654|P1|Participant Flow|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587072|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587073|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587074|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587075|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587128|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587076|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587077|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587078|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587079|NCT00550654|E1|Reported Event|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
587080|NCT00550589|B1|Baseline|Cidofovir|1.0% topical cidofovir cream
587081|NCT00550589|P1|Participant Flow|Cidofovir|1.0% topical cidofovir cream
587082|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
587083|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
587084|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
587085|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
587086|NCT00550589|O1|Outcome|Cidofovir|"1.0% topical cidofovir cream~cidofovir: 1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.~DNA methylation analysis: formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation~gene expression analysis: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~polymerase chain reaction: performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~biopsy: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~histopathologic examination: Evaluated at baseline and 6 weeks after treatment discontinuation"
587087|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
587088|NCT00550589|O1|Outcome|Cidofovir|1% cidofovir
587089|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
587090|NCT00550589|E1|Reported Event|Cidofovir|1.0% topical cidofovir cream
587091|NCT00550550|B3|Baseline|Total|Total of all reporting groups
587092|NCT00550550|B2|Baseline|Placebo|Matching placebo tablet administered sublingually once daily.
587093|NCT00550550|B1|Baseline|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
587094|NCT00550550|P2|Participant Flow|Placebo|Matching placebo tablet administered sublingually once daily.
587095|NCT00550550|P1|Participant Flow|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
587096|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
587097|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
587098|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
587099|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
587100|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
587101|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
587102|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
587103|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
587104|NCT00550550|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
587105|NCT00550550|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
587106|NCT00550537|B1|Baseline|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587107|NCT00550537|P1|Participant Flow|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587108|NCT00550537|O3|Outcome|Erlotinib|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587109|NCT00550537|O2|Outcome|Erlotinib Followed by PC+B|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587129|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587130|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587110|NCT00550537|O1|Outcome|Erlotinib Followed by PC|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587111|NCT00550537|O1|Outcome|Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587112|NCT00550537|O1|Outcome|Patients on Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587113|NCT00550537|O1|Outcome|Patients on Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587114|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587115|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587116|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587117|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587118|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587119|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587120|NCT00550537|E1|Reported Event|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
587121|NCT00550459|B3|Baseline|Total|Total of all reporting groups
587122|NCT00550459|B2|Baseline|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587123|NCT00550459|B1|Baseline|Placebo|Placebo tablet given once daily for 21 days
587124|NCT00550459|P2|Participant Flow|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587125|NCT00550459|P1|Participant Flow|Placebo|Placebo tablet given once daily for 21 days
587126|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587132|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587133|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587134|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587135|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587136|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587137|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587138|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587139|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587140|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587141|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587142|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587143|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587144|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587145|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587146|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587147|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587148|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587149|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587150|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587151|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587152|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587153|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587154|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587155|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587156|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587157|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587158|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587159|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587160|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587161|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587162|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587163|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587164|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587165|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587166|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587167|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587168|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587169|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587170|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587171|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587172|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587173|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587174|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587175|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587176|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587177|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587178|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587179|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587180|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587181|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587182|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587183|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
587184|NCT00550459|E2|Reported Event|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
587185|NCT00550459|E1|Reported Event|Placebo|Placebo tablet given once daily for 21 days
587186|NCT00550446|B8|Baseline|Total|Total of all reporting groups
587187|NCT00550446|B7|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587188|NCT00550446|B6|Baseline|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587189|NCT00550446|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587190|NCT00550446|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587191|NCT00550446|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587192|NCT00550446|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587193|NCT00550446|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587194|NCT00550446|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587195|NCT00550446|P10|Participant Flow|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587196|NCT00550446|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587197|NCT00550446|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587198|NCT00550446|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587199|NCT00550446|P6|Participant Flow|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587200|NCT00550446|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587201|NCT00550446|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587202|NCT00550446|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587203|NCT00550446|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587204|NCT00550446|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587205|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587206|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587207|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587208|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587209|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587210|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587211|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587212|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587213|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587214|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587215|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587216|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587217|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587218|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587219|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587220|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587221|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587222|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587223|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587224|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587225|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587226|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587227|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587228|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587229|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587230|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587231|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587232|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587233|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587234|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587235|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587236|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587237|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587238|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587239|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587240|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
589032|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
587241|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587242|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587243|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587244|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587245|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587246|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587247|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587248|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587249|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587250|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587251|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587252|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587253|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587254|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587255|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587256|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587257|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587258|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587259|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587260|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587261|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587262|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587263|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587264|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587265|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587266|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587267|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587268|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587269|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587270|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587271|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587272|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587273|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587274|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587275|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587276|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587277|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587278|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587279|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587280|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587281|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587282|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587283|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587284|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587285|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587286|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587287|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587288|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587289|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587290|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587798|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587291|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587292|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587293|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587294|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587295|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587296|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587297|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587298|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587299|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587300|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587301|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587302|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587303|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587304|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587305|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587306|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587307|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587308|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587309|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587310|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587311|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587312|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587313|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587314|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587315|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
589033|NCT00546871|O5|Outcome|Study Extension, SC Administration|
587316|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587317|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587318|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587319|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587320|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587321|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587322|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587323|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587324|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587325|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587326|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587327|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587328|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587329|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587330|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587331|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587332|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587333|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587334|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587335|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587336|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587337|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587338|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587339|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587340|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587341|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587342|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587343|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587344|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587345|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587346|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587347|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587348|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587349|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587350|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587351|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587352|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587353|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587354|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587355|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587356|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587357|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587358|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587359|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587360|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587361|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587362|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587363|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587364|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587365|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587366|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587367|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587368|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587369|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587370|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587371|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587372|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587373|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587374|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587375|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587376|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587377|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587378|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587379|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587380|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587381|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587382|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587383|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587384|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587385|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587386|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587387|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587388|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587389|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587390|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587415|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587391|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587392|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587393|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587394|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587395|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587396|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587397|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587398|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587399|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587400|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587401|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587402|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587403|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Participants who administered Adalimumab initially were switched to CP-690,550 5 milligram (mg) tablet from Week 12 to Week 24.
587404|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587405|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587406|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587407|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587408|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587409|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587410|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587411|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587412|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587413|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587414|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587752|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587416|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587417|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587418|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587419|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587420|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587421|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587422|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587423|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587424|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587425|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587426|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587427|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587428|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587429|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587430|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587431|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587432|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587433|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587434|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587435|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587436|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587437|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587438|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587439|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587440|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587441|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587442|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587443|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587444|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587445|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587446|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587447|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587448|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587449|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587450|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587451|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587452|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587453|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587454|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587455|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587456|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587457|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587458|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587459|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587460|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587461|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587462|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587463|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587464|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587465|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587515|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
589034|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
587466|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587467|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587468|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587469|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587470|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587471|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587472|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587473|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587474|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587475|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587476|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587477|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587478|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587479|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587480|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587481|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587482|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587483|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587484|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587485|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587486|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587487|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587488|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587489|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587516|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
589035|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
587490|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587491|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587492|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587493|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587494|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587495|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587496|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587497|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587498|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587499|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587500|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587501|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587502|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587503|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587504|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587505|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587506|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587507|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587508|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587509|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587510|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587511|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587512|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587513|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587514|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587517|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587518|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587519|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587520|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587521|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587522|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587523|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587524|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587525|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587526|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587527|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 10 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
587528|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587529|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Initially CP-690,550 3 mg tablet administered orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10. After Week 12, participants were reassigned CP-690,550 5 mg tablet administered orally twice daily.
587530|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587531|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587532|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587533|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587534|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587535|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587536|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587537|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587538|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587539|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587540|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587793|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587794|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587541|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587542|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587543|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587544|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587545|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587546|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587547|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587548|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587549|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587550|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587551|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587552|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587553|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587554|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587555|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587556|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587557|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587558|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587559|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587560|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587561|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 5 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
587562|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587563|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587564|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587795|NCT00550043|O1|Outcome|Placebo|
587796|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587565|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587566|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587567|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587568|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587569|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587570|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587571|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587572|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587573|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587574|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587575|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587576|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587577|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587578|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587579|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587580|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587581|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587582|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587583|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587584|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587585|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587586|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587587|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587588|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 15 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
587589|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587590|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587591|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587592|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587593|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587594|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587595|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587596|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587597|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587598|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587599|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587600|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587601|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587602|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587603|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587604|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587605|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587606|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587607|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587608|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587609|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587610|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587611|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587612|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587613|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587688|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587614|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587615|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587616|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587617|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587618|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587619|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587620|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587621|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587622|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587623|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587624|NCT00550446|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587625|NCT00550446|E10|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
587626|NCT00550446|E9|Reported Event|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in Adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587627|NCT00550446|E8|Reported Event|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
587628|NCT00550446|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587629|NCT00550446|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587630|NCT00550446|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
587631|NCT00550446|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587632|NCT00550446|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
587633|NCT00550446|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
587634|NCT00550446|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
587635|NCT00550420|B1|Baseline|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587689|NCT00550407|O1|Outcome|Placebo|Matching placebo
587690|NCT00550407|E3|Reported Event|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587636|NCT00550420|P1|Participant Flow|RSG XR 8 mg|Participants received rosiglitazone extended-release (RSG XR) 4 milligram (mg) tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587637|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587638|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587639|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587640|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587641|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587642|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587643|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587644|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587645|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587646|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587647|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587648|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587649|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587650|NCT00550420|O1|Outcome|RSG XR 8mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587651|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587652|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4 mg tablet orally once daily for first 4 weeks (W 0 to W 4) of treatment followed by RSG XR 8 mg tablet orally once daily from W 5 to W 104.
587691|NCT00550407|E2|Reported Event|Placebo|Matching placebo
587797|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587653|NCT00550420|O1|Outcome|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587654|NCT00550420|O1|Outcome|RSG XR 8mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587655|NCT00550420|E1|Reported Event|RSG XR 8 mg|Participants received RSG XR 4mg tablet once daily, orally for the first 4 weeks of the study followed by RSG XR 8mg tablet once daily, orally up to 52 weeks. If a participant and caregiver chose to extend treatment beyond the first 52 weeks, following re-consent, participants were allowed to continue the treatment and attended visits at the following time points every year: 12, 24, 36 and 52 weeks.
587656|NCT00550407|B3|Baseline|Total|Total of all reporting groups
587657|NCT00550407|B2|Baseline|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587658|NCT00550407|B1|Baseline|Placebo|Matching placebo
587659|NCT00550407|P3|Participant Flow|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587660|NCT00550407|P2|Participant Flow|Placebo|Matching placebo
587661|NCT00550407|P1|Participant Flow|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
587662|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587663|NCT00550407|O1|Outcome|Placebo|Matching placebo
587664|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587665|NCT00550407|O1|Outcome|Placebo|Matching placebo
587666|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587667|NCT00550407|O1|Outcome|Placebo|Matching placebo
587668|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587669|NCT00550407|O1|Outcome|Placebo|Matching placebo
587670|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
587671|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587672|NCT00550407|O1|Outcome|Placebo|Matching placebo
587673|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
587674|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587675|NCT00550407|O1|Outcome|Placebo|Matching placebo
587676|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
587677|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587678|NCT00550407|O1|Outcome|Placebo|Matching placebo
587679|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
587680|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587681|NCT00550407|O1|Outcome|Placebo|Matching placebo
587682|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587683|NCT00550407|O1|Outcome|Placebo|Matching placebo
587684|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587685|NCT00550407|O1|Outcome|Placebo|Matching placebo
587686|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
587687|NCT00550407|O1|Outcome|Placebo|Matching placebo
587751|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587692|NCT00550407|E1|Reported Event|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
587693|NCT00550394|B3|Baseline|Total|Total of all reporting groups
587694|NCT00550394|B2|Baseline|Quitiapine andTopiramate|"Quetiapine and Topiramate~Quetiapine andTopiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587695|NCT00550394|B1|Baseline|Quitiapine and Placebo|"Quetiapine and Placebo~quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587696|NCT00550394|P2|Participant Flow|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine and Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587697|NCT00550394|P1|Participant Flow|Quetiapine and Placebo|"Quetiapine and Placebo~quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587698|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
587699|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
587700|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
587701|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
587702|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
587703|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
587704|NCT00550394|O2|Outcome|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587705|NCT00550394|O1|Outcome|Quetiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587706|NCT00550394|E2|Reported Event|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587707|NCT00550394|E1|Reported Event|Quetiapine and Placebo|"Quetiapine and Placebo~quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
587708|NCT00550368|B3|Baseline|Total|Total of all reporting groups
587709|NCT00550368|B2|Baseline|H. Pylori Positive|Participants who tested H. pylori positive
587710|NCT00550368|B1|Baseline|H. Pylori Negative|Participants who tested negative for H. pylori infection.
587711|NCT00550368|P2|Participant Flow|H. Pylori Positive|Participants who tested H. pylori positive
587712|NCT00550368|P1|Participant Flow|H. Pylori Negative|Participants who tested negative for H. pylori infection.
587713|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
587714|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
587715|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
587716|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
587717|NCT00550368|E2|Reported Event|H. Pylori Positive|Participants who tested H. pylori positive
587718|NCT00550368|E1|Reported Event|H. Pylori Negative|Participants who tested negative for H. pylori infection.
587719|NCT00550277|B1|Baseline|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
587720|NCT00550277|P1|Participant Flow|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
587750|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587721|NCT00550277|O1|Outcome|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
587722|NCT00550277|E1|Reported Event|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
587723|NCT00550173|B4|Baseline|Total|Total of all reporting groups
587724|NCT00550173|B3|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587725|NCT00550173|B2|Baseline|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587726|NCT00550173|B1|Baseline|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587727|NCT00550173|P3|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587728|NCT00550173|P2|Participant Flow|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587729|NCT00550173|P1|Participant Flow|Pemetrexed + Erlotinib|Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587730|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587731|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587732|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587733|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587734|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587735|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587736|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587737|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587738|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587739|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587740|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587741|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587742|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587743|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587744|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587745|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587746|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587747|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587748|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
587749|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587753|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
587754|NCT00550173|E3|Reported Event|Pemetrexed|Participants received pemetrexed 500 mg/m^2 of body surface area, administered by intravenous (IV) infusion on Day 1 of each 21 day cycle until progression or unacceptable toxicity developed up to 39 months.
587755|NCT00550173|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg, administered orally once daily in each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
587756|NCT00550173|E1|Reported Event|Pemetrexed + Erlotinib|Participants received pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
587757|NCT00550147|B1|Baseline|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
587758|NCT00550147|P1|Participant Flow|OROS Methylphenidate and Quetiapine|This is the Baseline Visit, immediately after enrollment and prior to taking any medication. All enrolled subjects start taking OROS methylphenidate until Visit 5. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study; 2 subjects were withdrawn from the study prior to visit 5. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm. Visit 10 is measured at the end of OROS MPH+Quetiapine treatment
587759|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+Quetiapine after Week 13
587760|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after week 4
587761|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
587762|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
587763|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH Monotherapy after Week 4
587764|NCT00550147|O1|Outcome|Baseline|Baseline scores at Study Entry
587765|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
587766|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
587767|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
587768|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
587769|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
587770|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
587771|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with combined MPH and quetiapine after Week 13
587772|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
587773|NCT00550147|O1|Outcome|Baseline|Baseline score at study entry
587774|NCT00550147|E1|Reported Event|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
587775|NCT00550043|B6|Baseline|Total|Total of all reporting groups
587776|NCT00550043|B5|Baseline|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587777|NCT00550043|B4|Baseline|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587778|NCT00550043|B3|Baseline|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587779|NCT00550043|B2|Baseline|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587780|NCT00550043|B1|Baseline|Placebo|
587781|NCT00550043|P5|Participant Flow|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587782|NCT00550043|P4|Participant Flow|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587783|NCT00550043|P3|Participant Flow|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587784|NCT00550043|P2|Participant Flow|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587785|NCT00550043|P1|Participant Flow|Placebo|
587786|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587787|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587788|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587789|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587790|NCT00550043|O1|Outcome|Placebo|
587791|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587792|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587799|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587800|NCT00550043|O1|Outcome|Placebo|
587801|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587802|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587803|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587804|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587805|NCT00550043|O1|Outcome|Placebo|
587806|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587807|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587808|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587809|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587810|NCT00550043|O1|Outcome|Placebo|
587811|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587812|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587813|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587814|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587815|NCT00550043|O1|Outcome|Placebo|
587816|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587817|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587818|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587819|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587820|NCT00550043|O1|Outcome|Placebo|
587821|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587822|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587823|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587824|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587825|NCT00550043|O1|Outcome|Placebo|
587826|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587827|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587828|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587829|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587830|NCT00550043|O1|Outcome|Placebo|
587831|NCT00550043|E5|Reported Event|Cohort 2: Treatment Group D|INCB018424 50 mg QD
587832|NCT00550043|E4|Reported Event|Cohort 2: Treatment Group C|INCB018424 25 mg BID
587833|NCT00550043|E3|Reported Event|Cohort 2: Treatment Group B|INCB018424 5 mg BID
587834|NCT00550043|E2|Reported Event|Cohort 1: Treatment Group A|INCB018424 15 mg BID
587835|NCT00550043|E1|Reported Event|Placebo|
587836|NCT00549939|B4|Baseline|Total|Total of all reporting groups
587837|NCT00549939|B3|Baseline|Alfuzosin 0.2 mg/kg/Day|
587838|NCT00549939|B2|Baseline|Alfuzosin 0.1 mg/kg/Day|
587839|NCT00549939|B1|Baseline|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
587840|NCT00549939|P3|Participant Flow|Alfuzosin 0.2 mg/kg/Day|
587841|NCT00549939|P2|Participant Flow|Alfuzosin 0.1 mg/kg/Day|
587842|NCT00549939|P1|Participant Flow|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
587843|NCT00549939|O2|Outcome|Alfuzosin 0.2 mg/kg/Day|
587844|NCT00549939|O1|Outcome|Alfuzosin 0.1 mg/kg/Day|
587845|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
587846|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
587847|NCT00549939|O1|Outcome|Placebo|
587848|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
587849|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
587850|NCT00549939|O1|Outcome|Placebo|
587851|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
587852|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
587853|NCT00549939|O1|Outcome|Placebo|
587854|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
587855|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
587856|NCT00549939|O1|Outcome|Placebo|
587857|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
587858|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
587859|NCT00549939|O1|Outcome|Placebo|
587860|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
587861|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
587862|NCT00549939|O1|Outcome|Placebo|
587863|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
587864|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
587865|NCT00549939|O1|Outcome|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
587866|NCT00549939|E2|Reported Event|Alfuzosin 0.2 mg/kg/Day|
587867|NCT00549939|E1|Reported Event|Alfuzosin 0.1 mg/kg/Day|
587868|NCT00549900|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587869|NCT00549900|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587870|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587871|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587872|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587873|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587874|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
589036|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
587875|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587876|NCT00549900|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
587877|NCT00549822|B1|Baseline|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
587878|NCT00549822|P1|Participant Flow|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
587879|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
587880|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
587881|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
587882|NCT00549822|E1|Reported Event|Intermittent Letrozole Therapy|Letrozole 2.5mg: Intermittently
587883|NCT00549783|B3|Baseline|Total|Total of all reporting groups
587884|NCT00549783|B2|Baseline|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587885|NCT00549783|B1|Baseline|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587886|NCT00549783|P2|Participant Flow|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587887|NCT00549783|P1|Participant Flow|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587888|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587889|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587890|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587891|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587892|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587893|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587894|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587895|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587896|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587897|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587898|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587899|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587900|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587901|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587902|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587903|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587904|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587905|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587906|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587907|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587908|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587909|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587910|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587911|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587912|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587913|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587914|NCT00549783|E2|Reported Event|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587915|NCT00549783|E1|Reported Event|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
587916|NCT00549770|B9|Baseline|Total|Total of all reporting groups
587917|NCT00549770|B8|Baseline|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587918|NCT00549770|B7|Baseline|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587919|NCT00549770|B6|Baseline|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587920|NCT00549770|B5|Baseline|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587921|NCT00549770|B4|Baseline|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587922|NCT00549770|B3|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587923|NCT00549770|B2|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587924|NCT00549770|B1|Baseline|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587925|NCT00549770|P8|Participant Flow|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587926|NCT00549770|P7|Participant Flow|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587927|NCT00549770|P6|Participant Flow|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587928|NCT00549770|P5|Participant Flow|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587929|NCT00549770|P4|Participant Flow|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587930|NCT00549770|P3|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587931|NCT00549770|P2|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587932|NCT00549770|P1|Participant Flow|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587933|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587934|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587972|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587935|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587936|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587937|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587938|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587939|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587940|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587941|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587942|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587943|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587944|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587945|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587946|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587947|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587948|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587949|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587950|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587951|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587952|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587953|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587954|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587955|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587956|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587957|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587958|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587959|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587960|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587961|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587962|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587963|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587964|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587965|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587966|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587967|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587968|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587969|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587970|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587971|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587973|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587974|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587975|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587976|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587977|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587978|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587979|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587980|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587981|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587982|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587983|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587984|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587985|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587986|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587987|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587988|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587989|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587990|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587991|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587992|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587993|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587994|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587995|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587996|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587997|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
587998|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
587999|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588000|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588001|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588002|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588003|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588004|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588005|NCT00549770|E8|Reported Event|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588006|NCT00549770|E7|Reported Event|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
588007|NCT00549770|E6|Reported Event|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588008|NCT00549770|E5|Reported Event|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588009|NCT00549770|E4|Reported Event|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588163|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588010|NCT00549770|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588011|NCT00549770|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588012|NCT00549770|E1|Reported Event|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
588013|NCT00549757|B3|Baseline|Total|Total of all reporting groups
588014|NCT00549757|B2|Baseline|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
588015|NCT00549757|B1|Baseline|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
588016|NCT00549757|P2|Participant Flow|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
588017|NCT00549757|P1|Participant Flow|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
588018|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588019|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588020|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588021|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588022|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588023|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588024|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588025|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588026|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588027|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588028|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588029|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588030|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588164|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588031|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588032|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588033|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588034|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588035|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588036|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588037|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588038|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588039|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588040|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588041|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588042|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588043|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588044|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588045|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588046|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588047|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588048|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588049|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588050|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588051|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588052|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588053|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588054|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588055|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588056|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588057|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588058|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588059|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588060|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588061|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588062|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588063|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588064|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588065|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588066|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588067|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588068|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588069|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588070|NCT00549757|E4|Reported Event|Extension-phase: Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588071|NCT00549757|E3|Reported Event|Extension-phase: Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
588072|NCT00549757|E2|Reported Event|Core-phase: Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
588073|NCT00549757|E1|Reported Event|Core-phase: Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
588074|NCT00549718|B5|Baseline|Total|Total of all reporting groups
589037|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
588075|NCT00549718|B4|Baseline|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588076|NCT00549718|B3|Baseline|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
588077|NCT00549718|B2|Baseline|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588078|NCT00549718|B1|Baseline|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
588079|NCT00549718|P4|Participant Flow|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588080|NCT00549718|P3|Participant Flow|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
588081|NCT00549718|P2|Participant Flow|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588082|NCT00549718|P1|Participant Flow|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
588083|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588084|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
588085|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588086|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
588087|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588088|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
588089|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588090|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
588091|NCT00549718|E4|Reported Event|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588092|NCT00549718|E3|Reported Event|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
588093|NCT00549718|E2|Reported Event|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
588094|NCT00549718|E1|Reported Event|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
588095|NCT00549640|B3|Baseline|Total|Total of all reporting groups
588096|NCT00549640|B2|Baseline|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
588097|NCT00549640|B1|Baseline|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
588098|NCT00549640|P2|Participant Flow|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
588099|NCT00549640|P1|Participant Flow|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
588100|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
588101|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
588102|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
588103|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
588104|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
588105|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
588106|NCT00549640|E2|Reported Event|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
588107|NCT00549640|E1|Reported Event|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
588108|NCT00549601|B4|Baseline|Total|Total of all reporting groups
588109|NCT00549601|B3|Baseline|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588110|NCT00549601|B2|Baseline|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588111|NCT00549601|B1|Baseline|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588112|NCT00549601|P3|Participant Flow|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588113|NCT00549601|P2|Participant Flow|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588114|NCT00549601|P1|Participant Flow|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588115|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588116|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588117|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588118|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588119|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588120|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588121|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588122|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588123|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588124|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588125|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588126|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588207|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588127|NCT00549601|O2|Outcome|Rivastigmine 9.5 mg Patch|Rivastigmine transdermal patches at a constant dose: Application of one 9.5 mg patch every day for the whole treatment period.
588128|NCT00549601|O1|Outcome|Rivastigmine 4.6 mg/9.5 mg Patch|Rivastigmine transdermal patches at increasing doses: Application of one 4.6 mg patch every day for the first month of treatment and thereafter daily application of one 9.5 mg patch for the next two months.
588129|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588130|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588131|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588132|NCT00549601|E3|Reported Event|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
588133|NCT00549601|E2|Reported Event|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
588134|NCT00549601|E1|Reported Event|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
588135|NCT00549562|B1|Baseline|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588136|NCT00549562|P1|Participant Flow|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588137|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588138|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588139|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588140|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588141|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588142|NCT00549562|E1|Reported Event|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
588143|NCT00549549|B5|Baseline|Total|Total of all reporting groups
588144|NCT00549549|B4|Baseline|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588145|NCT00549549|B3|Baseline|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588146|NCT00549549|B2|Baseline|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588147|NCT00549549|B1|Baseline|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588148|NCT00549549|P4|Participant Flow|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588149|NCT00549549|P3|Participant Flow|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588150|NCT00549549|P2|Participant Flow|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588151|NCT00549549|P1|Participant Flow|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588152|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588153|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588154|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588155|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588156|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588157|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588158|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588159|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588160|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588161|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588162|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
589038|NCT00546871|O6|Outcome|Total SC (Study Parts 2, 3a, 3b, Extension)|
588165|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588166|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588167|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588168|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588169|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588170|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588171|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588172|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588173|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588174|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588175|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588176|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588177|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588178|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588179|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588180|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588181|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588182|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588183|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588184|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588185|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588186|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588187|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588188|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588189|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588190|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588191|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588192|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588193|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588194|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588195|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588196|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588197|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588198|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588199|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588200|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588201|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588202|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588203|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588204|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588205|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588206|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588208|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588209|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588210|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588211|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588212|NCT00549549|E4|Reported Event|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
588213|NCT00549549|E3|Reported Event|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
588214|NCT00549549|E2|Reported Event|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
588215|NCT00549549|E1|Reported Event|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
588216|NCT00549445|B3|Baseline|Total|Total of all reporting groups
588217|NCT00549445|B2|Baseline|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
588218|NCT00549445|B1|Baseline|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
588219|NCT00549445|P2|Participant Flow|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
588220|NCT00549445|P1|Participant Flow|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
588221|NCT00549445|O2|Outcome|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
588222|NCT00549445|O1|Outcome|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
588223|NCT00549445|E2|Reported Event|Placebo-treated|"Participants in the COPD Network Macrolide Study who received placebo for 1 year.~Placebo: Daily"
588224|NCT00549445|E1|Reported Event|Azithromycin-treated|"Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.~Azithromycin: 250 mg daily"
588225|NCT00549393|B3|Baseline|Total|Total of all reporting groups
588226|NCT00549393|B2|Baseline|Control Arm|Standard bathing with soap and water basin or disposable cloth
588227|NCT00549393|B1|Baseline|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
588228|NCT00549393|P2|Participant Flow|Standard Bath|Standard bathing with soap and water basin or disposable cloth
588229|NCT00549393|P1|Participant Flow|2% Chlorhexidine Gluconate Cloth|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
588230|NCT00549393|O2|Outcome|Control|Standard bathing with soap and water basin or disposable cloth
588231|NCT00549393|O1|Outcome|Treatment|Daily bathing with 2% chlorhexidine gluconate
588232|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
588233|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
588234|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
588235|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
588236|NCT00549393|E2|Reported Event|Control Arm|Standard bathing with soap and water basin or disposable cloth
588237|NCT00549393|E1|Reported Event|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
588238|NCT00549328|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588239|NCT00549328|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588240|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588241|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588242|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588243|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588244|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588245|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588246|NCT00549328|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
588247|NCT00549302|B3|Baseline|Total|Total of all reporting groups
588248|NCT00549302|B2|Baseline|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
588249|NCT00549302|B1|Baseline|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
588250|NCT00549302|P3|Participant Flow|Tadalafil 40 mg Open-Label|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Week 53 up to Week 243.
588251|NCT00549302|P2|Participant Flow|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
588252|NCT00549302|P1|Participant Flow|Tadalafil 20 mg Double Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
588253|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
588254|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
588255|NCT00549302|O2|Outcome|Tadalafil 40 mg|Tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment.
588256|NCT00549302|O1|Outcome|Tadalalfil 20 Milligrams (mg)|Tadalafil, 20 milligram (mg) tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment; LOCF.
588257|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
588258|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
588259|NCT00549302|O1|Outcome|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.
588260|NCT00549302|E1|Reported Event|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period.
588261|NCT00549198|B3|Baseline|Total|Total of all reporting groups
588262|NCT00549198|B2|Baseline|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588263|NCT00549198|B1|Baseline|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588264|NCT00549198|P2|Participant Flow|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588265|NCT00549198|P1|Participant Flow|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588266|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588267|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588268|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588269|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588270|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588271|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588272|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588273|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588274|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588275|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588276|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588277|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588278|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588279|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588280|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588281|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588282|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588283|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588284|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588285|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588286|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588287|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588288|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588289|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588290|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588291|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588292|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588293|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588294|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588295|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588296|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
589039|NCT00546871|O5|Outcome|Study Extension, SC Administration|
588297|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588298|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588299|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588300|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588301|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588302|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588303|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588304|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588305|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588306|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588307|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588308|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588309|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588310|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588311|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588312|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588313|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588314|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588315|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588316|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588317|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588318|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588319|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588320|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588321|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588322|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588323|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588324|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588325|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588326|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588327|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588328|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588329|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588330|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588331|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588332|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588333|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588334|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588335|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588336|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588337|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588338|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588339|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588340|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588341|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588342|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588343|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588344|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588345|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588346|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588347|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588348|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588349|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588350|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588351|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588352|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588353|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588354|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588355|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588356|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588357|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588358|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588359|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588360|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588361|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588362|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588363|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588364|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588365|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588366|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588367|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588368|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588369|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588370|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588371|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588372|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588373|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588374|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588375|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588376|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588377|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588378|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588379|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588380|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588381|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588382|NCT00549198|E2|Reported Event|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
588383|NCT00549198|E1|Reported Event|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
588384|NCT00549172|B3|Baseline|Total|Total of all reporting groups
588385|NCT00549172|B2|Baseline|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
588386|NCT00549172|B1|Baseline|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
588387|NCT00549172|P2|Participant Flow|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
588423|NCT00548860|E2|Reported Event|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
588388|NCT00549172|P1|Participant Flow|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
588389|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
588390|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
588391|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
588392|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
588393|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
588394|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
588395|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
588396|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
588397|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
588398|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
588399|NCT00549172|E2|Reported Event|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy"
588400|NCT00549172|E1|Reported Event|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus"
588401|NCT00549055|B1|Baseline|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588402|NCT00549055|P1|Participant Flow|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588403|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588404|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588405|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588406|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588407|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588408|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588409|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588410|NCT00549055|E1|Reported Event|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
588411|NCT00548886|B1|Baseline|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
588412|NCT00548886|P1|Participant Flow|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
588413|NCT00548886|O1|Outcome|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
588414|NCT00548886|O1|Outcome|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
588415|NCT00548886|E1|Reported Event|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
588416|NCT00548860|B3|Baseline|Total|Total of all reporting groups
588417|NCT00548860|B2|Baseline|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
588418|NCT00548860|B1|Baseline|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
588419|NCT00548860|P2|Participant Flow|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
588420|NCT00548860|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
588421|NCT00548860|O2|Outcome|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
588422|NCT00548860|O1|Outcome|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
588424|NCT00548860|E1|Reported Event|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
588425|NCT00548847|B1|Baseline|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
588426|NCT00548847|P1|Participant Flow|GM-CSF, Interferon-α-2b|Granulocyte-macrophage colony-stimulating factor (GM-CSF), Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
588427|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
588428|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
588429|NCT00548847|E1|Reported Event|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
588430|NCT00548808|B3|Baseline|Total|Total of all reporting groups
588431|NCT00548808|B2|Baseline|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588432|NCT00548808|B1|Baseline|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588433|NCT00548808|P2|Participant Flow|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588434|NCT00548808|P1|Participant Flow|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588435|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588436|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588437|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588438|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588439|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588440|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588441|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588442|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588443|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588444|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588445|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588446|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588447|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588448|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588449|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588450|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588451|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588452|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588453|NCT00548808|E2|Reported Event|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
588454|NCT00548808|E1|Reported Event|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
588455|NCT00548717|B3|Baseline|Total|Total of all reporting groups
588456|NCT00548717|B2|Baseline|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588457|NCT00548717|B1|Baseline|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
588458|NCT00548717|P2|Participant Flow|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)~*Bortezomib added when study reopened in November 2012"
588459|NCT00548717|P1|Participant Flow|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)"
588460|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588461|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
588462|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil,and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588463|NCT00548717|O1|Outcome|Siro /MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
588464|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588465|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
588466|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588467|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
588511|NCT00548470|O1|Outcome|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
589040|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
588468|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588469|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
588470|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588471|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
588472|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) *added with study reopening in 2012"
588473|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
588474|NCT00548717|E1|Reported Event|Siro/MMF (+/- Bortezomib)|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis (+/- Bortezomib)~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
588475|NCT00548691|B3|Baseline|Total|Total of all reporting groups
588476|NCT00548691|B2|Baseline|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
588477|NCT00548691|B1|Baseline|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
588478|NCT00548691|P2|Participant Flow|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
588479|NCT00548691|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
588480|NCT00548691|O2|Outcome|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
588481|NCT00548691|O1|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
588482|NCT00548691|E2|Reported Event|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
588483|NCT00548691|E1|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
588484|NCT00548548|B3|Baseline|Total|Total of all reporting groups
588485|NCT00548548|B2|Baseline|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588486|NCT00548548|B1|Baseline|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588487|NCT00548548|P2|Participant Flow|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588488|NCT00548548|P1|Participant Flow|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588489|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588490|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588491|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588492|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588512|NCT00548470|O1|Outcome|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
588513|NCT00548470|O1|Outcome|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
588493|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588494|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588495|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588496|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588497|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588498|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588499|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588500|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588501|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588502|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588503|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588504|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588505|NCT00548548|E2|Reported Event|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588506|NCT00548548|E1|Reported Event|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
588507|NCT00548470|B1|Baseline|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
588508|NCT00548470|P1|Participant Flow|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
588509|NCT00548470|O1|Outcome|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
588510|NCT00548470|O1|Outcome|Varenciline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
588669|NCT00548145|B2|Baseline|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
588514|NCT00548470|E1|Reported Event|Varenicline|"open label varenicline 2mg/day~Varenicline: Varenicline 1-2 mg/day"
588515|NCT00548431|B1|Baseline|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
588516|NCT00548431|P1|Participant Flow|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
588517|NCT00548431|O1|Outcome|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
588518|NCT00548431|E1|Reported Event|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
588519|NCT00548418|B1|Baseline|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588520|NCT00548418|P1|Participant Flow|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588521|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588522|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588523|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588524|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588525|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588526|NCT00548418|E1|Reported Event|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
588527|NCT00548405|B4|Baseline|Total|Total of all reporting groups
588528|NCT00548405|B3|Baseline|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
588529|NCT00548405|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
588530|NCT00548405|B1|Baseline|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588531|NCT00548405|P3|Participant Flow|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
588532|NCT00548405|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588533|NCT00548405|P1|Participant Flow|Interferon Beta-1a|Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588534|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588535|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588536|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588537|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588538|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588539|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588540|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588541|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588542|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588543|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588544|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588545|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588546|NCT00548405|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
588547|NCT00548405|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
588548|NCT00548405|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
588549|NCT00548405|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
588550|NCT00548340|B4|Baseline|Total|Total of all reporting groups
588551|NCT00548340|B3|Baseline|Placebo|Placebo: Placebo capsules, PO daily for five weeks
588552|NCT00548340|B2|Baseline|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
588553|NCT00548340|B1|Baseline|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
588554|NCT00548340|P3|Participant Flow|Placebo|Placebo: Placebo capsules, PO daily for five weeks
588555|NCT00548340|P2|Participant Flow|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
588556|NCT00548340|P1|Participant Flow|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
588557|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
588558|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
588559|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
588560|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
588561|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
588562|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
588563|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
588564|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
588565|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
588566|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
588567|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
588568|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
588569|NCT00548340|E3|Reported Event|Placebo|Placebo: Placebo capsules, PO daily for five weeks
588570|NCT00548340|E2|Reported Event|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
588571|NCT00548340|E1|Reported Event|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
588572|NCT00548327|B3|Baseline|Total|Total of all reporting groups
588573|NCT00548327|B2|Baseline|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588574|NCT00548327|B1|Baseline|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588575|NCT00548327|P2|Participant Flow|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588576|NCT00548327|P1|Participant Flow|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588577|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588600|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588621|NCT00548249|B3|Baseline|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588578|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588579|NCT00548327|O2|Outcome|Patients With Schizophrenia|
588580|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
588581|NCT00548327|O2|Outcome|Patients With Schizophrenia|
588582|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
588583|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588584|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588585|NCT00548327|O2|Outcome|Patients With Schizophrenia|
588586|NCT00548327|O1|Outcome|Healthy Participants|
588587|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588588|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
588589|NCT00548327|E4|Reported Event|Placebo-Healthy Volunteer|
588590|NCT00548327|E3|Reported Event|Atomoxetine-Healthy Volunteer|
588591|NCT00548327|E2|Reported Event|Placebo-Patient|
588592|NCT00548327|E1|Reported Event|Atomoxetine-Patient|
588593|NCT00548262|B1|Baseline|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588594|NCT00548262|P1|Participant Flow|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588595|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588596|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588597|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588598|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588599|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588619|NCT00548249|B5|Baseline|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588620|NCT00548249|B4|Baseline|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588601|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588602|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588603|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588604|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588605|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588606|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588607|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588608|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588609|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588610|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588611|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588612|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588613|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588614|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588615|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588616|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588617|NCT00548262|E1|Reported Event|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
588618|NCT00548249|B6|Baseline|Total|Total of all reporting groups
588668|NCT00548145|B3|Baseline|Total|Total of all reporting groups
588622|NCT00548249|B2|Baseline|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588623|NCT00548249|B1|Baseline|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588624|NCT00548249|P5|Participant Flow|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588625|NCT00548249|P4|Participant Flow|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588626|NCT00548249|P3|Participant Flow|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588627|NCT00548249|P2|Participant Flow|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588628|NCT00548249|P1|Participant Flow|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588629|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588630|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588631|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588632|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588633|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588634|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588635|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588636|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588637|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588638|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588639|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588640|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588641|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588642|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588643|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588644|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588645|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588646|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588647|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588648|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588649|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588650|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588651|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588652|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588653|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588654|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588655|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588656|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588657|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588658|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588659|NCT00548249|E5|Reported Event|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588660|NCT00548249|E4|Reported Event|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588661|NCT00548249|E3|Reported Event|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588662|NCT00548249|E2|Reported Event|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588663|NCT00548249|E1|Reported Event|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
588664|NCT00548184|B1|Baseline|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
588665|NCT00548184|P1|Participant Flow|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and Trastuzumab 4mg/kg loading dose and then 2mg/kg every week
588666|NCT00548184|O1|Outcome|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week
588667|NCT00548184|E1|Reported Event|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
588670|NCT00548145|B1|Baseline|Pitavastatin|2 mg by orally/day Duration: 12 months
588671|NCT00548145|P2|Participant Flow|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
588672|NCT00548145|P1|Participant Flow|Pitavastatin|2 mg by orally/day Duration: 12 months
588673|NCT00548145|O2|Outcome|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
588674|NCT00548145|O1|Outcome|Pitavastatin|2 mg by orally/day Duration: 12 months
588675|NCT00548145|E2|Reported Event|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
588676|NCT00548145|E1|Reported Event|Pitavastatin|2 mg by orally/day Duration: 12 months
588677|NCT00548132|B3|Baseline|Total|Total of all reporting groups
588678|NCT00548132|B2|Baseline|Chlorhexidine-impregnated Foam Dressing|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
588679|NCT00548132|B1|Baseline|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
588680|NCT00548132|P2|Participant Flow|Chlorhexidine-impregnated Foam Dressing|
588681|NCT00548132|P1|Participant Flow|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
588682|NCT00548132|O2|Outcome|Intervention Group|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
588683|NCT00548132|O1|Outcome|Standard of Care|Standard catheter care-use of chlorhexidine-alcohol solution to prep the catheter site and then a bioocclusive dressing is applied
588684|NCT00548132|O2|Outcome|Chlorhexidine Impregnated Sponge|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
588685|NCT00548132|O1|Outcome|Standard of Care|Standard of care
588686|NCT00548132|E2|Reported Event|Chlorhexidine-impregnated Foam Dressing|
588687|NCT00548132|E1|Reported Event|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
588688|NCT00548041|B1|Baseline|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
588689|NCT00548041|P1|Participant Flow|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
588690|NCT00548041|O1|Outcome|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
588691|NCT00548041|E1|Reported Event|Subjects Undergoing HIV Testing in the ED|
588692|NCT00547911|B5|Baseline|Total|Total of all reporting groups
588693|NCT00547911|B4|Baseline|Parkinson's Disease|Subjects with autonomic failure and a history of Parkinson's Disease
588694|NCT00547911|B3|Baseline|Multiple System Atrophy|Subjects with autonomic failure and a history of Multiple System Atrophy
588695|NCT00547911|B2|Baseline|Pure Autonomic Failure|Subjects with Pure Autonomic Failure
588696|NCT00547911|B1|Baseline|Healthy Volunteer|Subjects in good general health
588697|NCT00547911|P6|Participant Flow|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
588698|NCT00547911|P5|Participant Flow|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
588699|NCT00547911|P4|Participant Flow|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
588700|NCT00547911|P3|Participant Flow|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
588802|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588886|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588701|NCT00547911|P2|Participant Flow|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
588702|NCT00547911|P1|Participant Flow|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
588703|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
588704|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
588705|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
588706|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
588707|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
588708|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
588709|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
588710|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
588711|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
588712|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
588713|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of placebo
588714|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
588715|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
588716|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
588717|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
588718|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of carbidopa
588719|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
588720|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
588721|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
588722|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
588723|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
588724|NCT00547911|E6|Reported Event|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
588725|NCT00547911|E5|Reported Event|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
588726|NCT00547911|E4|Reported Event|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
588727|NCT00547911|E3|Reported Event|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
588728|NCT00547911|E2|Reported Event|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
588887|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588888|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588889|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588729|NCT00547911|E1|Reported Event|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
588730|NCT00547703|B3|Baseline|Total|Total of all reporting groups
588731|NCT00547703|B2|Baseline|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
588732|NCT00547703|B1|Baseline|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
588733|NCT00547703|P2|Participant Flow|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
588734|NCT00547703|P1|Participant Flow|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
588735|NCT00547703|O2|Outcome|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
588736|NCT00547703|O1|Outcome|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
588737|NCT00547703|E2|Reported Event|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
588738|NCT00547703|E1|Reported Event|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
588739|NCT00547638|B3|Baseline|Total|Total of all reporting groups
588740|NCT00547638|B2|Baseline|Dermabond HVD|DERMABOND HVD: Comparator Tissue Adhesive for Topical Application
588741|NCT00547638|B1|Baseline|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application
588742|NCT00547638|P2|Participant Flow|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588743|NCT00547638|P1|Participant Flow|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588744|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588745|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588746|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588747|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588748|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588749|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588750|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588751|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588752|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588753|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588754|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588755|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588756|NCT00547638|E2|Reported Event|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
588757|NCT00547638|E1|Reported Event|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
588758|NCT00547534|B1|Baseline|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
588759|NCT00547534|P1|Participant Flow|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
588760|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
588761|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated
588762|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
588763|NCT00547534|E1|Reported Event|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
588764|NCT00547521|B3|Baseline|Total|Total of all reporting groups
588765|NCT00547521|B2|Baseline|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588766|NCT00547521|B1|Baseline|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588767|NCT00547521|P2|Participant Flow|SC Abatacept Cohort|In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
588768|NCT00547521|P1|Participant Flow|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588769|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588770|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588771|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588772|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588773|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588774|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588775|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
588776|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
588777|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588778|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588779|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588780|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588781|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588782|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
588803|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588890|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588891|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588783|NCT00547521|O1|Outcome|Abatacept Long Term Extension (LTE) Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
588784|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588785|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588786|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588787|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588788|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
588789|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
588790|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588791|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588792|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588793|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588794|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588795|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588796|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588797|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588798|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
588799|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
588800|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588801|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588884|NCT00547118|P1|Participant Flow|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
588804|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588805|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588806|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588807|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588808|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588809|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588810|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588811|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588812|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588813|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588814|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588815|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588816|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588817|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588818|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588819|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588820|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588821|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588822|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588823|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588824|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
589041|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
588825|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588826|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588827|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588828|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588829|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588830|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588831|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588832|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588833|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588834|NCT00547521|E3|Reported Event|Long Term Extension (LTE):125 mg SC Abatacept|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
588835|NCT00547521|E2|Reported Event|Short Term Study: SC Abatacept Monotherapy|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
588836|NCT00547521|E1|Reported Event|Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
588837|NCT00547456|B1|Baseline|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
588838|NCT00547456|P1|Participant Flow|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
588839|NCT00547456|O1|Outcome|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
588840|NCT00547456|E1|Reported Event|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
588841|NCT00547378|B4|Baseline|Total|Total of all reporting groups
588842|NCT00547378|B3|Baseline|All Implanted Cohort: Non-randomized Subjects|These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system.
588843|NCT00547378|B2|Baseline|Randomized Cohort: Standard Medical Therapy|This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant.
588844|NCT00547378|B1|Baseline|Randomized Cohort: InterStim Therapy|This includes those subjects who were randomized to InterStim Therapy.
588845|NCT00547378|P3|Participant Flow|All Implanted/Non-Randomized Cohort|These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system.
588846|NCT00547378|P2|Participant Flow|Standard Medical Therapy|Randomized Cohort - Standard Medical Therapy. This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant.
588847|NCT00547378|P1|Participant Flow|InterStim Therapy|Randomized Cohort - InterStim Therapy. This includes those subjects who were randomized to InterStim Therapy.
588848|NCT00547378|O1|Outcome|All Implanted Cohort|The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
588885|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588849|NCT00547378|O1|Outcome|All Implanted Cohort|The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
588850|NCT00547378|O1|Outcome|All Implanted Cohort|The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
588851|NCT00547378|O2|Outcome|Standard Medical Therapy|Subjects who were randomized to Standard Medical Therapy group
588852|NCT00547378|O1|Outcome|InterStim Therapy|Subjects who were randomized to InterStim Therapy group
588853|NCT00547378|E3|Reported Event|All Implanted Cohort|The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
588854|NCT00547378|E2|Reported Event|Randomized Cohort: Standard Medical Therapy Group|Adverse events are summarized for those Subjects randomized are compliant to Standard Medical Therapy group (n=75). Out of 77 subjects, 2 subjects crossovered to InterStim Therapy group and received implant. These subjects are not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
588855|NCT00547378|E1|Reported Event|Randomized Cohort: InterStim Therapy Group|Adverse events are summarized for those subjects randomized to the InterStim Therapy group and received full system implant (n=51). Out of 70 subjects, there are 11 subjects who were not implanted with any device component, and 8 subjects who were implanted with lead only, but no neurostimulator. These subjects were not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
588856|NCT00547365|B1|Baseline|Human Immune Globulin Intravenous (IGIV)|
588857|NCT00547365|P1|Participant Flow|Human Immune Globulin Intravenous (IGIV)|The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was ~1 yr.
588858|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.
588859|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Immune globulin intravenous (IGIV) was administered to patients with cardiac-dominant AL amyloidosis in order to determine its therapeutic potential or possible toxicity when given to subjects weekly for 3 months and then every other week for the next 9 months. Response was evaluated by changes in serum anti-fibril antibody levels, changes in BNP (B-type natriuretic peptide) levels and IVS (interventricular septum) thickness.
588860|NCT00547365|E1|Reported Event|Human Immune Globulin Intravenous (IGIV)|Therapeutic potential of human immune globulin intravenous (IGIV)in patients with cardiac-associated AL amyloidosis
588861|NCT00547157|B3|Baseline|Total|Total of all reporting groups
588862|NCT00547157|B2|Baseline|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588863|NCT00547157|B1|Baseline|Panitumumab Plus Radiotherpy|Consists of Panitumumab and Radiotherpy
588864|NCT00547157|P2|Participant Flow|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588865|NCT00547157|P1|Participant Flow|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588866|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588867|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588868|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588869|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588870|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588871|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588872|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588873|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588874|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588875|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588876|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
588877|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588878|NCT00547157|E2|Reported Event|Chemotherapy Plus Radiotherapy|
588879|NCT00547157|E1|Reported Event|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
588880|NCT00547118|B3|Baseline|Total|Total of all reporting groups
588881|NCT00547118|B2|Baseline|Placebo|"Placebo~Placebo: Placebo"
588882|NCT00547118|B1|Baseline|Rimonabant|"Rimonabant~Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days."
588883|NCT00547118|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
588892|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588893|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588894|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588895|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588896|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588897|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588898|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588899|NCT00547118|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
588900|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
588901|NCT00547118|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
588902|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
588903|NCT00547118|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
588904|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
588905|NCT00547118|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
588906|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
588907|NCT00547118|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
588908|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
588909|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588910|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588911|NCT00547118|O2|Outcome|Placebo|Placebo tablet given 1 time per day for 112 days
588912|NCT00547118|O1|Outcome|Rimonabant|One 20 mg tablet given 1 time per day for 112 days.
588913|NCT00547118|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo"
588914|NCT00547118|E1|Reported Event|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
588915|NCT00547105|B1|Baseline|SBRT in Combination With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588916|NCT00547105|P1|Participant Flow|Stereotactic Body Radiation Therapy Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). Stereotactic Body Radiation Therapy (SBRT) will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588917|NCT00547105|O1|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588918|NCT00547105|O1|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588919|NCT00547105|O1|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588920|NCT00547105|O1|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588921|NCT00547105|O1|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588950|NCT00546897|P1|Participant Flow|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
589042|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
589043|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
589044|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
588922|NCT00547105|O1|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588923|NCT00547105|O1|Outcome|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588924|NCT00547105|E1|Reported Event|SBRT Combined With Erlotinib|"Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib~Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.~SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body"
588925|NCT00546910|B3|Baseline|Total|Total of all reporting groups
588926|NCT00546910|B2|Baseline|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588927|NCT00546910|B1|Baseline|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588928|NCT00546910|P2|Participant Flow|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588929|NCT00546910|P1|Participant Flow|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588930|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588931|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588932|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588933|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588934|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588935|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588936|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588937|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588938|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588939|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588940|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588941|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588942|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588943|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588944|NCT00546910|E2|Reported Event|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
588945|NCT00546910|E1|Reported Event|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
588946|NCT00546897|B3|Baseline|Total|Total of all reporting groups
588947|NCT00546897|B2|Baseline|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588948|NCT00546897|B1|Baseline|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588949|NCT00546897|P2|Participant Flow|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
589022|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
588951|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588952|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588953|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588954|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588955|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588956|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588957|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588958|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588959|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588960|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588961|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588962|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588963|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588964|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588965|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588966|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588967|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588968|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588969|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588970|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588971|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588972|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588973|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588974|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588975|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588976|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588977|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588978|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588979|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588980|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588981|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588982|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588983|NCT00546897|E2|Reported Event|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
588984|NCT00546897|E1|Reported Event|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
588985|NCT00546884|B3|Baseline|Total|Total of all reporting groups
588986|NCT00546884|B2|Baseline|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
588987|NCT00546884|B1|Baseline|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
588988|NCT00546884|P2|Participant Flow|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
589023|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
588989|NCT00546884|P1|Participant Flow|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
588990|NCT00546884|O2|Outcome|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
588991|NCT00546884|O1|Outcome|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
588992|NCT00546884|E2|Reported Event|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
588993|NCT00546884|E1|Reported Event|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
588994|NCT00546871|B1|Baseline|Treated Participants|
588995|NCT00546871|P2|Participant Flow|12 Years and Older|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted~Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:~If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a~If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
588996|NCT00546871|P1|Participant Flow|2 to <12 Years|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted~Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:~If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a~If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
588997|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
588998|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
588999|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589000|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
589001|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
589002|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
589003|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
589004|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
589005|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
589006|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
589007|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
589008|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
589009|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
589010|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589011|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
589012|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
589013|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589014|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
589015|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
589016|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589017|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
589018|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
589019|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589020|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
589021|NCT00546871|O5|Outcome|Study Extension, SC Administration|
589045|NCT00546871|O5|Outcome|Study Extension, SC Administration|
589046|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
589047|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
589048|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
589049|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
589050|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
589051|NCT00546871|O5|Outcome|Study Extension, SC Administration|
589052|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
589053|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
589054|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
589055|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
589056|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
589057|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
589058|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
589059|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
589060|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589061|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
589062|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
589063|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589064|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
589065|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
589066|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589067|NCT00546871|O3|Outcome|SESC|Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins
589068|NCT00546871|O2|Outcome|SNSC|Dataset of subjects naïve to SC administration of immunoglobulins
589069|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
589070|NCT00546871|O2|Outcome|All SC Treatment Periods|Study Parts 2, 3a, 3b, extension
589071|NCT00546871|O1|Outcome|IV Treatment|Study Part 1
589072|NCT00546871|O2|Outcome|12 Years and Older|
589073|NCT00546871|O1|Outcome|2 to <12 Years|
589074|NCT00546871|O1|Outcome|Full Safety Data Set|
589075|NCT00546871|O1|Outcome|All Participants|
589076|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
589077|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
589078|NCT00546871|O1|Outcome|All Participants|
589079|NCT00546871|O1|Outcome|All Participants|
589080|NCT00546871|O1|Outcome|12 Years and Older|
589081|NCT00546871|O1|Outcome|12 Years and Older|
589082|NCT00546871|O1|Outcome|12 Years and Older|
589083|NCT00546871|O1|Outcome|12 Years and Older|
589084|NCT00546871|O1|Outcome|12 Years and Older|
589085|NCT00546871|O1|Outcome|12 Years and Older|
589086|NCT00546871|O1|Outcome|12 Years and Older|
589087|NCT00546871|O1|Outcome|12 Years and Older|
589088|NCT00546871|O1|Outcome|12 Years and Older|
589089|NCT00546871|O1|Outcome|12 Years and Older|
589090|NCT00546871|O1|Outcome|12 Years and Older|
589091|NCT00546871|O1|Outcome|12 Years and Older|
589092|NCT00546871|O1|Outcome|12 Years and Older|
589093|NCT00546871|O1|Outcome|12 Years and Older|
589094|NCT00546871|O1|Outcome|Participants Aged 2 to <12 Years|
589095|NCT00546871|O1|Outcome|Participants ≥12 Years Old With PK Data Part 1 and Part 3b|"IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks).~SC dosing for Study Part 3b was determined by:~From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the Adjusted Dose.~Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an Individually Adapted Dose to ensure sufficient trough levels.~Study Part 3b:~Participants received weekly SC infusions for 12 weeks. Dose administered was either:~The Adjusted Dose~Individually Adapted Dose"
589096|NCT00546871|E2|Reported Event|SC Treatment Period|Study Parts 2, 3a, 3b, and Extension
589097|NCT00546871|E1|Reported Event|IV Treatment Period|Study Part 1
589098|NCT00546819|B3|Baseline|Total|Total of all reporting groups
589099|NCT00546819|B2|Baseline|Placebo|Participants administered Placebo on Day 1.
589100|NCT00546819|B1|Baseline|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
589101|NCT00546819|P2|Participant Flow|Placebo|Participants administered Placebo on Day 1.
589102|NCT00546819|P1|Participant Flow|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
589103|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
589104|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
589105|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
589106|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
589107|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
589108|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
589109|NCT00546819|E2|Reported Event|Placebo|Participants administered Placebo on Day 1.
589110|NCT00546819|E1|Reported Event|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
589111|NCT00546754|B3|Baseline|Total|Total of all reporting groups
589144|NCT00546728|B3|Baseline|Total|Total of all reporting groups
589178|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589112|NCT00546754|B2|Baseline|Valsartan 80 mg/HCTZ 12.5 mg|"Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
589113|NCT00546754|B1|Baseline|Losartan 50 mg/HCTZ 12.5 mg|"Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
589114|NCT00546754|P2|Participant Flow|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589115|NCT00546754|P1|Participant Flow|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589116|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589117|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589118|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589119|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589120|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589121|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589122|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589123|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589124|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589125|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589126|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589127|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589128|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589129|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589130|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589131|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589132|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589133|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589134|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589135|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589136|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589137|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589138|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589139|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589140|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589141|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589142|NCT00546754|E2|Reported Event|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589143|NCT00546754|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
589145|NCT00546728|B2|Baseline|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
589146|NCT00546728|B1|Baseline|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
589147|NCT00546728|P2|Participant Flow|Metformin|Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months.
589148|NCT00546728|P1|Participant Flow|Exenatide|Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months.
589149|NCT00546728|O2|Outcome|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
589150|NCT00546728|O1|Outcome|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
589151|NCT00546728|E2|Reported Event|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
589152|NCT00546728|E1|Reported Event|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
589153|NCT00546715|B5|Baseline|Total|Total of all reporting groups
589154|NCT00546715|B4|Baseline|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589155|NCT00546715|B3|Baseline|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589156|NCT00546715|B2|Baseline|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589157|NCT00546715|B1|Baseline|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589158|NCT00546715|P4|Participant Flow|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589159|NCT00546715|P3|Participant Flow|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589160|NCT00546715|P2|Participant Flow|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589161|NCT00546715|P1|Participant Flow|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589162|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589163|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589164|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589165|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589166|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589167|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589168|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589169|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589170|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589171|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589172|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589173|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589174|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589175|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589176|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589177|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589593|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
589179|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589180|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589181|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589182|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589183|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589184|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589185|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589186|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589187|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589188|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589189|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589190|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589191|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589192|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589193|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589194|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589195|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589196|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589197|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589198|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589199|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589200|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589201|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589202|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589203|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589204|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589205|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589206|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589207|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589208|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589209|NCT00546715|E4|Reported Event|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589210|NCT00546715|E3|Reported Event|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589211|NCT00546715|E2|Reported Event|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589212|NCT00546715|E1|Reported Event|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
589213|NCT00546637|B3|Baseline|Total|Total of all reporting groups
589214|NCT00546637|B2|Baseline|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589215|NCT00546637|B1|Baseline|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589216|NCT00546637|P2|Participant Flow|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589217|NCT00546637|P1|Participant Flow|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589218|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589219|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589220|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589221|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589222|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589223|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589224|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589225|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589226|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589332|NCT00546572|E1|Reported Event|13vPnC (Vax 1 / Year 0) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=66; systematic (solicited) Local Reactions N=209; systematic (solicited) Systemic Events N=234."
589227|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589228|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589229|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589230|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589231|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589232|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589233|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589234|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589235|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589236|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589237|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589238|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589239|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589240|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589241|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589242|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589243|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589244|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589245|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589246|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589247|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589248|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589249|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589250|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589251|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589252|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589253|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589254|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589255|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589328|NCT00546572|E5|Reported Event|13vPnC / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=191; systematic (solicited) Systemic Events N=161."
589333|NCT00546481|B3|Baseline|Total|Total of all reporting groups
589256|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589257|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589258|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589259|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589260|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589261|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589262|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589263|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589264|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589265|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589266|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589267|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589268|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589269|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589329|NCT00546572|E4|Reported Event|23vPS 6-M FU (Vax 1 / Year 0)|23vPS 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-M FU (Vax 1 / Year 0) telephone visit to report new events.
589330|NCT00546572|E3|Reported Event|13vPnC 6-M FU (Vax 1 / Year 0)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-Month Follow-up visit (6-M FU) (Vax 1 / Year 0) telephone visit to report new events.
589270|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589271|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589272|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589273|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589274|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589275|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589276|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589277|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589278|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589279|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589280|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589281|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589282|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589283|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589331|NCT00546572|E2|Reported Event|23vPS (Vax 1 / Year 0) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=83; systematic (solicited) Local Reactions N=248; systematic (solicited) Systemic Events N=275."
589417|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589284|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589285|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589286|NCT00546637|E2|Reported Event|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
589287|NCT00546637|E1|Reported Event|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
589288|NCT00546572|B3|Baseline|Total|Total of all reporting groups
589289|NCT00546572|B2|Baseline|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589290|NCT00546572|B1|Baseline|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589291|NCT00546572|P2|Participant Flow|23vPS / 13vPnC|23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
589292|NCT00546572|P1|Participant Flow|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
589293|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589294|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589295|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax )
589296|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589297|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589298|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589299|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589300|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589301|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589302|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589303|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589304|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589305|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589306|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589307|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589308|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589309|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589310|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589311|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589312|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589313|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589314|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589315|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589316|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589317|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
589318|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589319|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589320|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589321|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589322|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589323|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
589324|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
589325|NCT00546572|E8|Reported Event|23vPS / 13vPnC 6-M FU (Vax 2 / Year 1)|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose at Year 1 (Vax 2); events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
589326|NCT00546572|E7|Reported Event|13vPnC / 13vPnC 6-M FU (Vax 2 / Year 1)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2) ; events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
589327|NCT00546572|E6|Reported Event|23vPS / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=62; systematic (solicited) Local Reactions N=189; systematic (solicited) Systemic Events N=174."
589418|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589334|NCT00546481|B2|Baseline|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589335|NCT00546481|B1|Baseline|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589336|NCT00546481|P3|Participant Flow|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
589337|NCT00546481|P2|Participant Flow|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589338|NCT00546481|P1|Participant Flow|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589339|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589340|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589341|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589342|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589343|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589344|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589345|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
589346|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589347|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589348|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
589349|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589350|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589351|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589352|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589353|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589354|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589355|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589356|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589357|NCT00546481|E3|Reported Event|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined protocol) IV once every 4 weeks for the subsequent 24 weeks.
589358|NCT00546481|E2|Reported Event|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
589359|NCT00546481|E1|Reported Event|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
589360|NCT00546429|B1|Baseline|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
589361|NCT00546429|P1|Participant Flow|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
589362|NCT00546429|O1|Outcome|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
589363|NCT00546429|E1|Reported Event|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
589364|NCT00546377|B1|Baseline|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
589590|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
589365|NCT00546377|P1|Participant Flow|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
589366|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
589367|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
589368|NCT00546377|E1|Reported Event|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
589369|NCT00546364|B4|Baseline|Total|Total of all reporting groups
589370|NCT00546364|B3|Baseline|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589371|NCT00546364|B2|Baseline|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589372|NCT00546364|B1|Baseline|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589373|NCT00546364|P3|Participant Flow|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589374|NCT00546364|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589375|NCT00546364|P1|Participant Flow|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589376|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589377|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589378|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589379|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589380|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589381|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589382|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589383|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589384|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589385|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589386|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589387|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589591|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
589388|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589389|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589390|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589391|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589392|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589393|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589394|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589395|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589396|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589397|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589398|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589399|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589400|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589401|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589402|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589403|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589404|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589405|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
589406|NCT00546364|E3|Reported Event|Ixabepilone 40|
589407|NCT00546364|E2|Reported Event|Ixabepilone 32|
589408|NCT00546364|E1|Reported Event|Docetaxel|
589409|NCT00546351|B1|Baseline|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589410|NCT00546351|P1|Participant Flow|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589411|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589412|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589413|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589414|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589415|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589416|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589419|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589420|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589421|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589422|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589423|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589424|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589425|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589426|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589427|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589428|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589429|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589430|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589431|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589432|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589433|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589434|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589435|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589436|NCT00546351|E1|Reported Event|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
589437|NCT00546273|B6|Baseline|Total|Total of all reporting groups
589438|NCT00546273|B5|Baseline|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
589439|NCT00546273|B4|Baseline|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
589440|NCT00546273|B3|Baseline|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
589441|NCT00546273|B2|Baseline|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
589442|NCT00546273|B1|Baseline|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
589443|NCT00546273|P5|Participant Flow|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
589444|NCT00546273|P4|Participant Flow|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
589445|NCT00546273|P3|Participant Flow|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
589446|NCT00546273|P2|Participant Flow|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
589447|NCT00546273|P1|Participant Flow|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
589448|NCT00546273|O5|Outcome|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
589449|NCT00546273|O4|Outcome|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
589450|NCT00546273|O3|Outcome|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
589451|NCT00546273|O2|Outcome|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
589452|NCT00546273|O1|Outcome|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
589453|NCT00546260|B3|Baseline|Total|Total of all reporting groups
589454|NCT00546260|B2|Baseline|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
589455|NCT00546260|B1|Baseline|Placebo|Placebo Comparator
589456|NCT00546260|P2|Participant Flow|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
589457|NCT00546260|P1|Participant Flow|Placebo|Placebo Comparator
589458|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
589459|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
589460|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
589461|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
589462|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
589463|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
589464|NCT00546260|E2|Reported Event|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
589465|NCT00546260|E1|Reported Event|Placebo|Placebo Comparator
589466|NCT00546156|B3|Baseline|Total|Total of all reporting groups
589467|NCT00546156|B2|Baseline|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
589468|NCT00546156|B1|Baseline|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
589469|NCT00546156|P2|Participant Flow|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
589470|NCT00546156|P1|Participant Flow|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
589471|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
589472|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
589473|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
589474|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
589475|NCT00546156|E1|Reported Event|All Study Participants|Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
589476|NCT00546117|B3|Baseline|Total|Total of all reporting groups
589477|NCT00546117|B2|Baseline|Placebo|Placebo SoluTab once daily for 2 months
589478|NCT00546117|B1|Baseline|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
589479|NCT00546117|P2|Participant Flow|Placebo|Placebo SoluTab once daily for 2 months
589480|NCT00546117|P1|Participant Flow|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
589481|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
589482|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
589483|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
589484|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
589485|NCT00546117|E2|Reported Event|Placebo|Placebo SoluTab once daily for 2 months
589486|NCT00546117|E1|Reported Event|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
589487|NCT00546104|B1|Baseline|Dasatinib|50-100mg by mouth twice a day
589488|NCT00546104|P1|Participant Flow|Dasatinib|50-100 mg PO BID
589489|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
589490|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
589491|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
589492|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
589493|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
589494|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
589495|NCT00546104|E1|Reported Event|Dasatinib|50-100mg po bid
589496|NCT00546078|B3|Baseline|Total|Total of all reporting groups
589497|NCT00546078|B2|Baseline|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589498|NCT00546078|B1|Baseline|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589499|NCT00546078|P2|Participant Flow|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589500|NCT00546078|P1|Participant Flow|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589501|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589502|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589503|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589504|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589505|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589506|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589507|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589508|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589509|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589510|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589511|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589512|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589513|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589514|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589515|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589516|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589592|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
589517|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589518|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589519|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589520|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589521|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589522|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589523|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589524|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589525|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589526|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589527|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589528|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589529|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589530|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589531|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589532|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589533|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589534|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589535|NCT00546078|E2|Reported Event|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
589536|NCT00546078|E1|Reported Event|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
589537|NCT00546052|B1|Baseline|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
589538|NCT00546052|P1|Participant Flow|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
589539|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589540|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589541|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589542|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589543|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589544|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589545|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589546|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589547|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589548|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589549|NCT00546052|O3|Outcome|Overall Per Protocol|All patients completing the 52 week study follow up.
589550|NCT00546052|O2|Outcome|Overall Intend to Treat|All patients enrolled and receiving at least one dose of study drug and having at least one follow up visit.
589551|NCT00546052|O1|Outcome|Overall Total|All patients enrolled (signed the informed consent).
589552|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589553|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
589554|NCT00546052|E1|Reported Event|Overall ITT|
589555|NCT00546000|B1|Baseline|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
589556|NCT00546000|P1|Participant Flow|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
589557|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
589558|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
589559|NCT00546000|E1|Reported Event|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
589560|NCT00545974|B3|Baseline|Total|Total of all reporting groups
589561|NCT00545974|B2|Baseline|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
589562|NCT00545974|B1|Baseline|Memantine|Memantine 10mg administered orally twice daily
589563|NCT00545974|P2|Participant Flow|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
589564|NCT00545974|P1|Participant Flow|Memantine|Memantine 10mg administered orally twice daily
589565|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
589566|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
589567|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
589568|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
589569|NCT00545974|E2|Reported Event|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
589570|NCT00545974|E1|Reported Event|Memantine|Memantine 10mg administered orally twice daily
589571|NCT00545948|B4|Baseline|Total|Total of all reporting groups
589572|NCT00545948|B3|Baseline|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
589573|NCT00545948|B2|Baseline|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
589574|NCT00545948|B1|Baseline|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
589575|NCT00545948|P3|Participant Flow|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
589576|NCT00545948|P2|Participant Flow|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
589577|NCT00545948|P1|Participant Flow|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
589578|NCT00545948|O2|Outcome|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
589579|NCT00545948|O1|Outcome|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
589580|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
589581|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study.
589582|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
589583|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
589584|NCT00545948|E2|Reported Event|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
589585|NCT00545948|E1|Reported Event|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
589586|NCT00545844|B1|Baseline|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
589587|NCT00545844|P1|Participant Flow|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
589588|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
589589|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
589594|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
589595|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
589596|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 8|
589597|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
589598|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
589599|NCT00545844|E1|Reported Event|All Patients|
589600|NCT00545792|B1|Baseline|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
589601|NCT00545792|P1|Participant Flow|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
589602|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
589603|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
589604|NCT00545792|E1|Reported Event|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
589605|NCT00545779|B1|Baseline|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589606|NCT00545779|P1|Participant Flow|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589607|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589608|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589609|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589610|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589611|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589612|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589613|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589614|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589615|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589616|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589617|NCT00545779|E1|Reported Event|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
589618|NCT00545766|B1|Baseline|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
589619|NCT00545766|P1|Participant Flow|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
589620|NCT00545766|O1|Outcome|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
589621|NCT00545766|E1|Reported Event|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
589622|NCT00545753|B4|Baseline|Total|Total of all reporting groups
589623|NCT00545753|B3|Baseline|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
589624|NCT00545753|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse - 1% - nit comb regimen required
589625|NCT00545753|B1|Baseline|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse - 1% - no nit combing required
589626|NCT00545753|P3|Participant Flow|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
589627|NCT00545753|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
589628|NCT00545753|P1|Participant Flow|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
589629|NCT00545753|O2|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
589630|NCT00545753|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
589631|NCT00545753|O3|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
589632|NCT00545753|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
589633|NCT00545753|O1|Outcome|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
589634|NCT00545753|E2|Reported Event|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
589635|NCT00545753|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse - 1% - With or without nit combing
589636|NCT00545740|B5|Baseline|Total|Total of all reporting groups
589637|NCT00545740|B4|Baseline|Placebo|Placebo administered orally once daily
589638|NCT00545740|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
589639|NCT00545740|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
589640|NCT00545740|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
589641|NCT00545740|P4|Participant Flow|Placebo|Placebo administered orally once daily
589642|NCT00545740|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
589643|NCT00545740|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
589644|NCT00545740|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
589645|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
589646|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589647|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589648|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
589649|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
589650|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589651|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589652|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
589653|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
589654|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589655|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589656|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
589657|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
589658|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589659|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589660|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
589661|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
589662|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589663|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589664|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
589665|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
589666|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589667|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589668|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
589669|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
589670|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589671|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589672|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
589673|NCT00545740|E4|Reported Event|Placebo|Placebo administered orally once daily
589674|NCT00545740|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
589675|NCT00545740|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
589676|NCT00545740|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
589677|NCT00545688|B5|Baseline|Total|Total of all reporting groups
589678|NCT00545688|B4|Baseline|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589679|NCT00545688|B3|Baseline|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589680|NCT00545688|B2|Baseline|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589776|NCT00545623|E4|Reported Event|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
589681|NCT00545688|B1|Baseline|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589682|NCT00545688|P4|Participant Flow|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589683|NCT00545688|P3|Participant Flow|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589684|NCT00545688|P2|Participant Flow|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589685|NCT00545688|P1|Participant Flow|Trastuzumab + Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab intravenous (IV) infusion at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by 5-fluorouracil 600 mg/m^2 IV, epirubicin 90 mg/m^2 IV, and cyclophosphamide 600 mg/m^2 IV (FEC) on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589686|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589687|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589688|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589689|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589690|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589777|NCT00545623|E3|Reported Event|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
590806|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
589691|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589692|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589693|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589694|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589695|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589696|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589697|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589698|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589699|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589700|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589778|NCT00545623|E2|Reported Event|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589701|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589702|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589703|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589704|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589705|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589706|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589707|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589708|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589709|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589710|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589779|NCT00545623|E1|Reported Event|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589780|NCT00545584|B4|Baseline|Total|Total of all reporting groups
589711|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589712|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589713|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589714|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589715|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589716|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589717|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589718|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589719|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589720|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589880|NCT00545272|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589721|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589722|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589723|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589724|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589725|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589726|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589727|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589728|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589729|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589730|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589781|NCT00545584|B3|Baseline|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
589731|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589732|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589733|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589734|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589735|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589736|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589737|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589738|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589739|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589740|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589881|NCT00545272|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589741|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589742|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589743|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589744|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589745|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589746|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589747|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589748|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589749|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589750|NCT00545688|E4|Reported Event|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
589782|NCT00545584|B2|Baseline|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
589783|NCT00545584|B1|Baseline|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
589751|NCT00545688|E3|Reported Event|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
589752|NCT00545688|E2|Reported Event|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589753|NCT00545688|E1|Reported Event|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
589754|NCT00545662|B3|Baseline|Total|Total of all reporting groups
589755|NCT00545662|B2|Baseline|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589756|NCT00545662|B1|Baseline|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589757|NCT00545662|P2|Participant Flow|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589758|NCT00545662|P1|Participant Flow|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589759|NCT00545662|O2|Outcome|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589760|NCT00545662|O1|Outcome|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589761|NCT00545662|E2|Reported Event|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589762|NCT00545662|E1|Reported Event|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
589763|NCT00545623|B5|Baseline|Total|Total of all reporting groups
589764|NCT00545623|B4|Baseline|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
589765|NCT00545623|B3|Baseline|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
589766|NCT00545623|B2|Baseline|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589767|NCT00545623|B1|Baseline|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589768|NCT00545623|P4|Participant Flow|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
589769|NCT00545623|P3|Participant Flow|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
589770|NCT00545623|P2|Participant Flow|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589771|NCT00545623|P1|Participant Flow|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589772|NCT00545623|O4|Outcome|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
589773|NCT00545623|O3|Outcome|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
589774|NCT00545623|O2|Outcome|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589775|NCT00545623|O1|Outcome|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
589827|NCT00545402|B3|Baseline|Total|Total of all reporting groups
589784|NCT00545584|P3|Participant Flow|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
589785|NCT00545584|P2|Participant Flow|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
589786|NCT00545584|P1|Participant Flow|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
589787|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
589788|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
589789|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
589790|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
589791|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
589792|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
589793|NCT00545584|E3|Reported Event|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
589794|NCT00545584|E2|Reported Event|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
589795|NCT00545584|E1|Reported Event|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
589796|NCT00545571|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589797|NCT00545571|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week dose titration period (DTP) to maintain hemoglobin (Hb) concentrations within a country-specific target: 11.0 to 13.0 grams per deciliter (g/dL) in Switzerland and 10.0 to 12.0 g/dL in Austria.
589798|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589799|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589800|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589801|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589802|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
590054|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
589803|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589804|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589805|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589806|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589807|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589808|NCT00545571|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
589809|NCT00545506|B3|Baseline|Total|Total of all reporting groups
589810|NCT00545506|B2|Baseline|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
589811|NCT00545506|B1|Baseline|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
589812|NCT00545506|P2|Participant Flow|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
589813|NCT00545506|P1|Participant Flow|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
589814|NCT00545506|O2|Outcome|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
589815|NCT00545506|O1|Outcome|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
589816|NCT00545506|E2|Reported Event|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
589817|NCT00545506|E1|Reported Event|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
589818|NCT00545441|B3|Baseline|Total|Total of all reporting groups
589819|NCT00545441|B2|Baseline|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
589820|NCT00545441|B1|Baseline|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
589821|NCT00545441|P2|Participant Flow|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
589822|NCT00545441|P1|Participant Flow|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
589823|NCT00545441|O2|Outcome|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
589824|NCT00545441|O1|Outcome|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
589825|NCT00545441|E2|Reported Event|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
589826|NCT00545441|E1|Reported Event|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
589828|NCT00545402|B2|Baseline|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589829|NCT00545402|B1|Baseline|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589830|NCT00545402|P2|Participant Flow|Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS)|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589831|NCT00545402|P1|Participant Flow|Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid|Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve [AUC]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.
589832|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589833|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589834|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589835|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589836|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589837|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589851|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589882|NCT00545272|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589838|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589839|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589840|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589841|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589842|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589843|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589844|NCT00545402|E2|Reported Event|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
589845|NCT00545402|E1|Reported Event|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
589846|NCT00545363|B3|Baseline|Total|Total of all reporting groups
589847|NCT00545363|B2|Baseline|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589848|NCT00545363|B1|Baseline|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
589849|NCT00545363|P2|Participant Flow|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589850|NCT00545363|P1|Participant Flow|Bone Marker Feedback (BMF) Participants|"Postmenopausal women received ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, received bone marker feedback (BMF) at Month 3. BMF was given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by patient relationship program (PRP), carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
592145|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
589852|NCT00545363|O1|Outcome|BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A “BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589853|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589854|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
589855|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589856|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
589857|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589858|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
589859|NCT00545363|E2|Reported Event|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
589860|NCT00545363|E1|Reported Event|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
589861|NCT00545298|B4|Baseline|Total|Total of all reporting groups
589862|NCT00545298|B3|Baseline|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
589863|NCT00545298|B2|Baseline|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
589864|NCT00545298|B1|Baseline|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
589865|NCT00545298|P3|Participant Flow|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
589866|NCT00545298|P2|Participant Flow|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
589867|NCT00545298|P1|Participant Flow|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
589868|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
589869|NCT00545298|O2|Outcome|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
589870|NCT00545298|O1|Outcome|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
589871|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
589872|NCT00545298|O2|Outcome|A - Standard of Care (Control)|Standard of Care - dressings and sustained compression only
589873|NCT00545298|O1|Outcome|B - Same Treatment for 6 Weeks|This group received 200ppm NO in Nitrogen delivered constantly to a patch over the wound for 8 hours per day for 6 weeks
589874|NCT00545298|E3|Reported Event|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
589875|NCT00545298|E2|Reported Event|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
589876|NCT00545298|E1|Reported Event|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
589877|NCT00545272|B7|Baseline|Total|Total of all reporting groups
589878|NCT00545272|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589879|NCT00545272|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
590044|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
592146|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
589883|NCT00545272|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589884|NCT00545272|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589885|NCT00545272|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589886|NCT00545272|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589887|NCT00545272|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589888|NCT00545272|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589889|NCT00545272|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589890|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589891|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589892|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589893|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589894|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589895|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589896|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589897|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589898|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589899|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589900|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589901|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589902|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589903|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589904|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589905|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589906|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589907|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589908|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589909|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589910|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589911|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589912|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589913|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589914|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589915|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589916|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589917|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589918|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589919|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589920|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589921|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589922|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589923|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589924|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589925|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589926|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589927|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589928|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589929|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589930|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589931|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589932|NCT00545272|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589933|NCT00545272|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
589934|NCT00545272|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589935|NCT00545272|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589936|NCT00545272|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589937|NCT00545272|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
589938|NCT00545233|B3|Baseline|Total|Total of all reporting groups
589939|NCT00545233|B2|Baseline|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589940|NCT00545233|B1|Baseline|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589941|NCT00545233|P2|Participant Flow|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589942|NCT00545233|P1|Participant Flow|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589943|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589944|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
590045|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
590046|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
590047|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589945|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589946|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589947|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589948|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589949|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589950|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589951|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589952|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589953|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589954|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589955|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589956|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589957|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589958|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
590048|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
590049|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
589959|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589960|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589961|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589962|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589963|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589964|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589965|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589966|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589967|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589968|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589969|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589970|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589971|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of piogliatzone per day orally in the 24 week follow-up period.
589972|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
590050|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
590051|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
589973|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589974|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589975|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589976|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589977|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589978|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589979|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589980|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589981|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589982|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589983|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589984|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
589985|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589986|NCT00545233|E2|Reported Event|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
590052|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
590053|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
589987|NCT00545233|E1|Reported Event|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
589988|NCT00545181|B3|Baseline|Total|Total of all reporting groups
589989|NCT00545181|B2|Baseline|Metronidazole Alone|Metronidazole antibiotic therapy alone
589990|NCT00545181|B1|Baseline|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
589991|NCT00545181|P2|Participant Flow|Metronidazole Alone|Metronidazole antibiotic therapy alone
589992|NCT00545181|P1|Participant Flow|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
589993|NCT00545181|O2|Outcome|Metronidazole Alone|Metronidazole antibiotic therapy alone
589994|NCT00545181|O1|Outcome|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
589995|NCT00545181|E2|Reported Event|Metronidazole Alone|Metronidazole antibiotic therapy alone
589996|NCT00545181|E1|Reported Event|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
589997|NCT00545168|B4|Baseline|Total|Total of all reporting groups
589998|NCT00545168|B3|Baseline|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
589999|NCT00545168|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
590000|NCT00545168|B1|Baseline|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
590001|NCT00545168|P3|Participant Flow|C - NIX|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
590002|NCT00545168|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
590003|NCT00545168|P1|Participant Flow|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
590004|NCT00545168|O3|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
590005|NCT00545168|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
590006|NCT00545168|O1|Outcome|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
590007|NCT00545168|O2|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
590008|NCT00545168|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
590009|NCT00545168|E2|Reported Event|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
590010|NCT00545168|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
590011|NCT00545155|B1|Baseline|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590012|NCT00545155|P1|Participant Flow|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590013|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590014|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590015|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590016|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590017|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590018|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590019|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590020|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590021|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590022|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590023|NCT00545155|E1|Reported Event|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
590024|NCT00545103|B5|Baseline|Total|Total of all reporting groups
590025|NCT00545103|B4|Baseline|Placebo|Placebo administered orally once daily
590026|NCT00545103|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
590027|NCT00545103|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
590028|NCT00545103|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
590029|NCT00545103|P4|Participant Flow|Placebo|Placebo administered orally once daily
590030|NCT00545103|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
590031|NCT00545103|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
590032|NCT00545103|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
590033|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
590034|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
590035|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
590036|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
590037|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
590038|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
590039|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
590040|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
590041|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
590042|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
590043|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
590055|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
590056|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
590057|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
590058|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
590059|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
590060|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
590061|NCT00545103|E4|Reported Event|Placebo|Placebo administered orally once daily
590062|NCT00545103|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
590063|NCT00545103|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
590064|NCT00545103|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
590065|NCT00545064|B1|Baseline|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
590066|NCT00545064|P1|Participant Flow|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
590067|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
590068|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
590069|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
590070|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
590071|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
590072|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
590073|NCT00545064|E1|Reported Event|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
590074|NCT00545051|B3|Baseline|Total|Total of all reporting groups
590075|NCT00545051|B2|Baseline|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590076|NCT00545051|B1|Baseline|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590077|NCT00545051|P2|Participant Flow|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590078|NCT00545051|P1|Participant Flow|Ibandronate|Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day.
590079|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590080|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590081|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590082|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590083|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590084|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590085|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590086|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590087|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590088|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590089|NCT00545051|E2|Reported Event|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590090|NCT00545051|E1|Reported Event|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
590091|NCT00545025|B3|Baseline|Total|Total of all reporting groups
590092|NCT00545025|B2|Baseline|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590093|NCT00545025|B1|Baseline|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590324|NCT00543764|P2|Participant Flow|Post Pathway|Patients after pathway implementation
590094|NCT00545025|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590095|NCT00545025|P1|Participant Flow|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590096|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590097|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590098|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590099|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590100|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590101|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590102|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590103|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590104|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590105|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590106|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590107|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590108|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
592147|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
590109|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590110|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590111|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590112|NCT00545025|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
590113|NCT00545025|E1|Reported Event|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
590114|NCT00544908|B1|Baseline|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
590115|NCT00544908|P1|Participant Flow|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
590116|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
590117|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
590118|NCT00544908|E1|Reported Event|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
590119|NCT00544882|B3|Baseline|Total|Total of all reporting groups
590120|NCT00544882|B2|Baseline|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590121|NCT00544882|B1|Baseline|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590122|NCT00544882|P3|Participant Flow|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590123|NCT00544882|P2|Participant Flow|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590124|NCT00544882|P1|Participant Flow|Run-In Cycle - All Enrolled|After completing screening, all enrolled participants received the same regimen of 150 μg Desogestrel (DSG) /20 μg Ethinyl Estradiol (EE) combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1.
590125|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590126|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590165|NCT00544778|P1|Participant Flow|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
590166|NCT00544778|O1|Outcome|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
590325|NCT00543764|P1|Participant Flow|Pre Pathway|Patients prior to pathway implementation
590127|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590128|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590129|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590130|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590131|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590132|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590133|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590134|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590135|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590136|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590137|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590138|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590139|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590140|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590141|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590142|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590143|NCT00544882|E2|Reported Event|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590144|NCT00544882|E1|Reported Event|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
590145|NCT00544869|B4|Baseline|Total|Total of all reporting groups
590146|NCT00544869|B3|Baseline|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
590147|NCT00544869|B2|Baseline|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
590148|NCT00544869|B1|Baseline|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
590149|NCT00544869|P3|Participant Flow|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
590150|NCT00544869|P2|Participant Flow|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
590151|NCT00544869|P1|Participant Flow|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
590152|NCT00544869|O3|Outcome|Dose Escalated to 30 mg/Day|
590153|NCT00544869|O2|Outcome|Continued at 15 mg/Day|
590154|NCT00544869|O1|Outcome|Stopped at End of Treatment Period 1|
590155|NCT00544869|E3|Reported Event|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
590156|NCT00544869|E2|Reported Event|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
590157|NCT00544869|E1|Reported Event|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
590158|NCT00544817|B1|Baseline|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
590159|NCT00544817|P1|Participant Flow|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
590160|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
590161|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
590162|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
590163|NCT00544817|E1|Reported Event|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
590164|NCT00544778|B1|Baseline|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
590167|NCT00544778|E1|Reported Event|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
590168|NCT00544713|B3|Baseline|Total|Total of all reporting groups
590169|NCT00544713|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590170|NCT00544713|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590171|NCT00544713|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590172|NCT00544713|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590173|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590174|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590175|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590176|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590177|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590178|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590179|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590180|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590181|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590182|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590183|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590184|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590185|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590186|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590187|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590188|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590189|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590190|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590191|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590192|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590193|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590194|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590195|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590196|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590197|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590198|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590199|NCT00544713|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
590200|NCT00544713|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
590201|NCT00544674|B1|Baseline|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
590202|NCT00544674|P1|Participant Flow|PR104|Subjects will receive 1100 mg/m^2 PR-104 intravenously once every 21 days (one cycle). In addition, subjects will undergo positron emission topography (PET) imaging with F-18-Fluoro Misonidazole (FMISO) for the assessment of hypoxia and with F-18-Fluorodeoxyglucose (FDG) for the assessment of glucose metabolism.
590203|NCT00544674|O1|Outcome|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
590204|NCT00544674|E1|Reported Event|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
590205|NCT00544648|B3|Baseline|Total|Total of all reporting groups
590206|NCT00544648|B2|Baseline|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590207|NCT00544648|B1|Baseline|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
590208|NCT00544648|P2|Participant Flow|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590209|NCT00544648|P1|Participant Flow|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
590230|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
592148|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
590210|NCT00544648|O1|Outcome|Phase I and Phase II|"Phase I-Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-MTD Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-"
590211|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590212|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590213|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590214|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 with concurrent radiotherapy
590215|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
590216|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
590217|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
590218|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590219|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
590220|NCT00544648|E2|Reported Event|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590221|NCT00544648|E1|Reported Event|Phase I|Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
590222|NCT00544557|B1|Baseline|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590223|NCT00544557|P1|Participant Flow|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590224|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590225|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590226|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590227|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590228|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590229|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590318|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
592149|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
590231|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590232|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590233|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590234|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590235|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590236|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590237|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590238|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590239|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590240|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590241|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590242|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590243|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590244|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590245|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590246|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590247|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590248|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590249|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590319|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590326|NCT00543764|O2|Outcome|Post Pathway|Patients after pathway implementation
590250|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590251|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590252|NCT00544557|E1|Reported Event|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
590253|NCT00544544|B1|Baseline|Riluzole|Riluzole 100-200 mg/day
590254|NCT00544544|P1|Participant Flow|Riluzole|Riluzole 100-200 mg/day
590255|NCT00544544|O1|Outcome|Riluzole|Riluzole 100-200 mg/day
590256|NCT00544544|E1|Reported Event|Riluzole|Riluzole 100-200 mg/day
590257|NCT00544440|B1|Baseline|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
590258|NCT00544440|P1|Participant Flow|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
590259|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
590260|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
590261|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
590262|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
590263|NCT00544440|E1|Reported Event|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
590264|NCT00544167|B1|Baseline|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|Doxorubicin 60mg/m2 IV, Cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 12 weeks followed by 12 weeks of paclitaxel (either 175mg/m2 IV every three weeks or 80mg/m2 IV weekly) and sorafenib 400mg twice daily by mouth (up to a maximum of 1 year).
590265|NCT00544167|P1|Participant Flow|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
590266|NCT00544167|O1|Outcome|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|
590267|NCT00544167|E1|Reported Event|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
590268|NCT00543985|B1|Baseline|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' and VO2 max.
590269|NCT00543985|P1|Participant Flow|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
590270|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
590271|NCT00543985|O1|Outcome|Stress Echocardiography|"Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.~Stress Echocardiography: Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol."
590272|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured after exercise
590273|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured before and after exercise
590274|NCT00543985|E1|Reported Event|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' .
590275|NCT00543855|B5|Baseline|Total|Total of all reporting groups
590276|NCT00543855|B4|Baseline|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590277|NCT00543855|B3|Baseline|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
590320|NCT00543803|E1|Reported Event|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
590321|NCT00543764|B3|Baseline|Total|Total of all reporting groups
590322|NCT00543764|B2|Baseline|Post Pathway|Patients after pathway implementation
590278|NCT00543855|B2|Baseline|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
590279|NCT00543855|B1|Baseline|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590280|NCT00543855|P4|Participant Flow|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590281|NCT00543855|P3|Participant Flow|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."
590282|NCT00543855|P2|Participant Flow|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
590283|NCT00543855|P1|Participant Flow|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590284|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590285|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
590286|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
590287|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590288|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590289|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
590290|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
590291|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590292|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590293|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
590294|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
590295|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590296|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590297|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
590298|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
590299|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590300|NCT00543855|E4|Reported Event|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590301|NCT00543855|E3|Reported Event|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
590302|NCT00543855|E2|Reported Event|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
590303|NCT00543855|E1|Reported Event|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
590304|NCT00543803|B1|Baseline|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590305|NCT00543803|P1|Participant Flow|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590306|NCT00543803|O2|Outcome|Last Evaluation Assessment on Treatment|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
590307|NCT00543803|O1|Outcome|Evaluation Assessment at Baseline|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
590308|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590309|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590310|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590311|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590312|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590313|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590314|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590315|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590316|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590317|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
590323|NCT00543764|B1|Baseline|Pre Pathway|Patients prior to pathway implementation
590327|NCT00543764|O1|Outcome|Pre Pathway|Patients prior to pathway implementation
590328|NCT00543764|E2|Reported Event|Post Pathway|Patients after pathway implementation
590329|NCT00543764|E1|Reported Event|Pre Pathway|Patients prior to pathway implementation
590330|NCT00543725|B3|Baseline|Total|Total of all reporting groups
590331|NCT00543725|B2|Baseline|Efavirenz|600 mg once daily
590332|NCT00543725|B1|Baseline|TMC278|25 mg tablet once daily
590333|NCT00543725|P2|Participant Flow|Efavirenz|600 mg once daily
590334|NCT00543725|P1|Participant Flow|TMC278|25 mg tablet once daily
590335|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590336|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590337|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590338|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590339|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590340|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590341|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590342|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590343|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590344|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590345|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590346|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590347|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590348|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590349|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590350|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590351|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
590352|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
590353|NCT00543725|E2|Reported Event|Efavirenz|600 mg once daily
590354|NCT00543725|E1|Reported Event|TMC278|25 mg tablet once daily
590355|NCT00543569|B5|Baseline|Total|Total of all reporting groups
590356|NCT00543569|B4|Baseline|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590357|NCT00543569|B3|Baseline|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590358|NCT00543569|B2|Baseline|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590359|NCT00543569|B1|Baseline|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590360|NCT00543569|P4|Participant Flow|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590361|NCT00543569|P3|Participant Flow|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590362|NCT00543569|P2|Participant Flow|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590363|NCT00543569|P1|Participant Flow|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590364|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590365|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590366|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590367|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590368|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
593698|NCT00536263|B4|Baseline|Total|Total of all reporting groups
590369|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590370|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590371|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590372|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590373|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590374|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590375|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590376|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590377|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590378|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590379|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590380|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590381|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590382|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590383|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590384|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590385|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590386|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590387|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590445|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590388|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590389|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590390|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590391|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590392|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590393|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590394|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590395|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590396|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590397|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590398|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590399|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590400|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590401|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590402|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590403|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590404|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590405|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590406|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590467|NCT00543543|B2|Baseline|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590407|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590408|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590409|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590410|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590411|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590412|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590413|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590414|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590415|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590416|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590417|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590418|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590419|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590420|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590421|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590422|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590423|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590424|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590425|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590468|NCT00543543|B1|Baseline|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590644|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
594284|NCT00534833|B3|Baseline|Total|Total of all reporting groups
590426|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590427|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590428|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590429|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590430|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590431|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590432|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590433|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590434|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590435|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590436|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590437|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590438|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590439|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590440|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590441|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590442|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590443|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590444|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590469|NCT00543543|P4|Participant Flow|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590446|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590447|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590448|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590449|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590450|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590451|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590452|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590453|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590454|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590455|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590456|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590457|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590458|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590459|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590460|NCT00543569|E4|Reported Event|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
590461|NCT00543569|E3|Reported Event|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
590462|NCT00543569|E2|Reported Event|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
590463|NCT00543569|E1|Reported Event|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
590464|NCT00543543|B5|Baseline|Total|Total of all reporting groups
590465|NCT00543543|B4|Baseline|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590466|NCT00543543|B3|Baseline|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590470|NCT00543543|P3|Participant Flow|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590471|NCT00543543|P2|Participant Flow|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590472|NCT00543543|P1|Participant Flow|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590473|NCT00543543|O1|Outcome|Extension Study: Mid-dose V503 (Cohort 1)|V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590474|NCT00543543|O1|Outcome|Extension Study: Mid-dose V503 (Cohort 1)|V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590475|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590476|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590477|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590478|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590479|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590480|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590481|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590482|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590483|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590484|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590485|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590486|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590487|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590488|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590489|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590490|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590491|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590492|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590493|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590494|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590495|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590496|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590497|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590498|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590499|NCT00543543|O1|Outcome|Extension Study: Mid-dose V503 (Cohort 1)|V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590500|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590501|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590502|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590503|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590504|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
590642|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
590505|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
590506|NCT00543543|E6|Reported Event|Extension Study: Mid-dose V503 (Cohort 2)|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL 3-dose regimen administration on Base Study participants who were randomized to receive a 3-dose regimen of Gardasil (4-Valent HPV Vaccine) (Cohort 2).
590507|NCT00543543|E5|Reported Event|Extension Study: Mid-dose V503 (Cohort 1)|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL fourth dose administration in Base Study participants who were randomized to receive a 3-dose regimen of V503 (9-Valent HPV) mid-dose 0.5 mL (Cohort 1).
590508|NCT00543543|E4|Reported Event|Base Study: Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) will be offered the V503 mid-dose 3-dose regimen in the extension study.
590509|NCT00543543|E3|Reported Event|Base Study: High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
590510|NCT00543543|E2|Reported Event|Base Study: Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) will receive a fourth V503 mid-dose vaccination in the extension study.
590511|NCT00543543|E1|Reported Event|Base Study: Low-Dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
590512|NCT00543400|B5|Baseline|Total|Total of all reporting groups
590513|NCT00543400|B4|Baseline|100 IU/KG of M118|Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590514|NCT00543400|B3|Baseline|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590515|NCT00543400|B2|Baseline|50 IU/KG of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590516|NCT00543400|B1|Baseline|70 U/kg of Unfractionated Heparin Given IV|Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590517|NCT00543400|P4|Participant Flow|100 IU/kg of M118|Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590518|NCT00543400|P3|Participant Flow|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590519|NCT00543400|P2|Participant Flow|50 IU/kg of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590520|NCT00543400|P1|Participant Flow|70 U/kg of Unfractionated Heparin Given IV|Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590521|NCT00543400|O4|Outcome|100 IU/kg of M118|Venous injection of 100 IU/kg of M118 prior to Percutaneous Coronary Intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590522|NCT00543400|O3|Outcome|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590523|NCT00543400|O2|Outcome|50 IU/kg of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590524|NCT00543400|O1|Outcome|70 U/kg of Unfractionated Heparin Given IV|Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590525|NCT00543400|E4|Reported Event|100 IU/kg of M118|Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590526|NCT00543400|E3|Reported Event|75 IU/KG of M118|Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590527|NCT00543400|E2|Reported Event|50 IU/kg of M118|Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590528|NCT00543400|E1|Reported Event|70 U/kg of Unfractionated Heparin Given IV|Venous injection of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
590529|NCT00543296|B1|Baseline|0.59 mg Fluocinolone Acetonide Implant|
590530|NCT00543296|P1|Participant Flow|0.59 mg Fluocinolone Acetonide Implant|
590531|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
590532|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
590533|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
590534|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
590535|NCT00543296|E1|Reported Event|0.59 mg Fluocinolone Acetonide Implant|
590536|NCT00543140|B1|Baseline|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590537|NCT00543140|P1|Participant Flow|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590538|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590539|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590540|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590541|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590542|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590543|NCT00543140|E1|Reported Event|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
590544|NCT00543101|B3|Baseline|Total|Total of all reporting groups
590545|NCT00543101|B2|Baseline|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
590546|NCT00543101|B1|Baseline|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
590547|NCT00543101|P2|Participant Flow|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
590548|NCT00543101|P1|Participant Flow|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
590549|NCT00543101|O2|Outcome|Crossover Week 48|At week 24 the dual PI arm subjects remaining undetectable, crossed over to the DRV/r arm and were followed for an additional 24 weeks.
590550|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
590551|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
590552|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
590553|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
590554|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
590555|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
590556|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
590557|NCT00543101|E2|Reported Event|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
590558|NCT00543101|E1|Reported Event|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
590559|NCT00542997|B1|Baseline|IgPro20 (All Treated)|All subjects enrolled and treated with subcutaneous infusion of IgPro20
590560|NCT00542997|P1|Participant Flow|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
590561|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
590562|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
590563|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
590564|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
590565|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
590566|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
590567|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
590568|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
590569|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
590570|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
590571|NCT00542997|O2|Outcome|Pre-study IgG Treatment|Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
590572|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
590573|NCT00542997|E1|Reported Event|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
590574|NCT00542971|B1|Baseline|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
590575|NCT00542971|P1|Participant Flow|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
590576|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
590577|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
590578|NCT00542971|E1|Reported Event|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
590579|NCT00542880|B3|Baseline|Total|Total of all reporting groups
590580|NCT00542880|B2|Baseline|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590643|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
590581|NCT00542880|B1|Baseline|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590582|NCT00542880|P2|Participant Flow|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590583|NCT00542880|P1|Participant Flow|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590584|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590585|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590586|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590587|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590588|NCT00542880|O2|Outcome|Seretide Diskus First|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590589|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590590|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590591|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590592|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590593|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590594|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590595|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590596|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590597|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590598|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590599|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590600|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590601|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590602|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590603|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590604|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590605|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590606|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590607|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590608|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590609|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590610|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590611|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590612|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590613|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590614|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590615|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590616|NCT00542880|E2|Reported Event|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
590617|NCT00542880|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
590618|NCT00542828|B1|Baseline|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590619|NCT00542828|P1|Participant Flow|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590620|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590621|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590622|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590623|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590624|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590625|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590626|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590627|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590628|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590629|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590630|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590631|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590632|NCT00542828|E1|Reported Event|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
590633|NCT00542815|B4|Baseline|Total|Total of all reporting groups
590634|NCT00542815|B3|Baseline|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
590635|NCT00542815|B2|Baseline|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
590636|NCT00542815|B1|Baseline|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
590637|NCT00542815|P3|Participant Flow|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
590638|NCT00542815|P2|Participant Flow|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
590639|NCT00542815|P1|Participant Flow|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
590640|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
590641|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
590645|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
590646|NCT00542815|E3|Reported Event|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
590647|NCT00542815|E2|Reported Event|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
590648|NCT00542815|E1|Reported Event|MCI-196 From E07/E08 Studies|3, 6, 9, 12, or 15g / day as titrated
590649|NCT00542789|B3|Baseline|Total|Total of all reporting groups
590650|NCT00542789|B2|Baseline|Comparater: Placebo|Placebo once daily oral
590651|NCT00542789|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
590652|NCT00542789|P2|Participant Flow|Comparater: Placebo|Placebo once daily oral
590653|NCT00542789|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
590654|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
590655|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
590656|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
590657|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
590658|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
590659|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
590660|NCT00542789|E2|Reported Event|Comparater: Placebo|Placebo once daily oral
590661|NCT00542789|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
590662|NCT00542750|B1|Baseline|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
590663|NCT00542750|P1|Participant Flow|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
590664|NCT00542750|O1|Outcome|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
590665|NCT00542750|E1|Reported Event|N-acetylcysteine|All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
590666|NCT00542620|B3|Baseline|Total|Total of all reporting groups
590667|NCT00542620|B2|Baseline|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590668|NCT00542620|B1|Baseline|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590669|NCT00542620|P2|Participant Flow|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590670|NCT00542620|P1|Participant Flow|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590671|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590672|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590673|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590674|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590675|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590676|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590677|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590678|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590679|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590680|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590681|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590682|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590683|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590684|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590685|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590686|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590687|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590688|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590689|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590690|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590691|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590692|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590693|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590694|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590695|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590696|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590697|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590698|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590699|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590700|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590701|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590702|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590703|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590704|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590705|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590706|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590707|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590708|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590709|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590710|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590801|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
590802|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
590711|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590712|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590713|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590714|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590715|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590716|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590717|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590718|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590719|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590720|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590721|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590722|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590723|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590724|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590725|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590726|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590727|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590728|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590729|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590730|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590731|NCT00542620|E2|Reported Event|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590732|NCT00542620|E1|Reported Event|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
590733|NCT00542542|B3|Baseline|Total|Total of all reporting groups
590734|NCT00542542|B2|Baseline|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
590735|NCT00542542|B1|Baseline|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
590736|NCT00542542|P2|Participant Flow|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
590737|NCT00542542|P1|Participant Flow|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
590803|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
590804|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
590738|NCT00542542|O2|Outcome|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
590739|NCT00542542|O1|Outcome|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
590740|NCT00542542|E2|Reported Event|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
590741|NCT00542542|E1|Reported Event|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
590742|NCT00542490|B1|Baseline|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
590743|NCT00542490|P1|Participant Flow|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
590744|NCT00542490|O1|Outcome|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
590745|NCT00542490|O1|Outcome|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
590746|NCT00542490|E1|Reported Event|Vaginal Cuff Brachytherapy|"Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged.~Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)"
590747|NCT00542425|B6|Baseline|Total|Total of all reporting groups
590748|NCT00542425|B5|Baseline|Teriparatide|
590749|NCT00542425|B4|Baseline|BA058 80 µg|
590750|NCT00542425|B3|Baseline|BA058 40 µg|
590751|NCT00542425|B2|Baseline|BA058 20 µg|
590752|NCT00542425|B1|Baseline|Placebo|
590753|NCT00542425|P5|Participant Flow|Teriparatide|
590754|NCT00542425|P4|Participant Flow|BA058 80 µg|
590755|NCT00542425|P3|Participant Flow|BA058 40 µg|
590756|NCT00542425|P2|Participant Flow|BA058 20 µg|
590757|NCT00542425|P1|Participant Flow|Placebo|
590758|NCT00542425|O5|Outcome|Teriparatide|
590759|NCT00542425|O4|Outcome|BA058 80 µg|
590760|NCT00542425|O3|Outcome|BA058 40 µg|
590761|NCT00542425|O2|Outcome|BA058 20 µg|
590762|NCT00542425|O1|Outcome|Placebo|
590763|NCT00542425|O5|Outcome|Teriparatide|
590764|NCT00542425|O4|Outcome|BA058 80 µg|
590765|NCT00542425|O3|Outcome|BA058 40 µg|
590766|NCT00542425|O2|Outcome|BA058 20 µg|
590767|NCT00542425|O1|Outcome|Placebo|
590768|NCT00542425|O5|Outcome|Teriparatide|
590769|NCT00542425|O4|Outcome|BA058 80 µg|
590770|NCT00542425|O3|Outcome|BA058 40 µg|
590771|NCT00542425|O2|Outcome|BA058 20 µg|
590772|NCT00542425|O1|Outcome|Placebo|
590773|NCT00542425|O5|Outcome|Teriparatide|
590774|NCT00542425|O4|Outcome|BA058 80 µg|
590775|NCT00542425|O3|Outcome|BA058 40 µg|
590776|NCT00542425|O2|Outcome|BA058 20 µg|
590777|NCT00542425|O1|Outcome|Placebo|
590778|NCT00542425|O5|Outcome|Teriparatide|
590779|NCT00542425|O4|Outcome|BA058 80 µg|
590780|NCT00542425|O3|Outcome|BA058 40 µg|
590781|NCT00542425|O2|Outcome|BA058 20 µg|
590782|NCT00542425|O1|Outcome|Placebo|
590783|NCT00542425|E5|Reported Event|Teriparatide|
590784|NCT00542425|E4|Reported Event|BA058 80 µg|
590785|NCT00542425|E3|Reported Event|BA058 40 µg|
590786|NCT00542425|E2|Reported Event|BA058 20 µg|
590787|NCT00542425|E1|Reported Event|Placebo|
590788|NCT00542386|B7|Baseline|Total|Total of all reporting groups
590789|NCT00542386|B6|Baseline|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
590790|NCT00542386|B5|Baseline|MCI-196: 15 g|MCI-196: 15 g/ day
590791|NCT00542386|B4|Baseline|MCI-196: 12 g|MCI-196: 12 g/ day
590792|NCT00542386|B3|Baseline|MCI-196: 9 g|MCI-196: 9 g/ day
590793|NCT00542386|B2|Baseline|MCI-196: 6 g|MCI-196: 6 g/ day
590794|NCT00542386|B1|Baseline|MCI-196: 3 g|MCI-196: 3 g/ day
590795|NCT00542386|P6|Participant Flow|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
590796|NCT00542386|P5|Participant Flow|MCI-196: 15 g|MCI-196: 15 g/ day
590797|NCT00542386|P4|Participant Flow|MCI-196: 12 g|MCI-196: 12 g/ day
590798|NCT00542386|P3|Participant Flow|MCI-196: 9 g|MCI-196: 9 g/ day
590799|NCT00542386|P2|Participant Flow|MCI-196: 6 g|MCI-196: 6 g/ day
590800|NCT00542386|P1|Participant Flow|MCI-196: 3 g|MCI-196: 3 g/ day
590805|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
590807|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
590808|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
590809|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
590810|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
590811|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
590812|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
590813|NCT00542386|E6|Reported Event|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
590814|NCT00542386|E5|Reported Event|MCI-196: 15 g|MCI-196: 15 g/ day
590815|NCT00542386|E4|Reported Event|MCI-196: 12 g|MCI-196: 12 g/ day
590816|NCT00542386|E3|Reported Event|MCI-196: 9 g|MCI-196: 9 g/ day
590817|NCT00542386|E2|Reported Event|MCI-196: 6 g|MCI-196: 6 g/ day
590818|NCT00542386|E1|Reported Event|MCI-196: 3 g|MCI-196: 3 g/ day
590819|NCT00542321|B3|Baseline|Total|Total of all reporting groups
590820|NCT00542321|B2|Baseline|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590821|NCT00542321|B1|Baseline|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590822|NCT00542321|P2|Participant Flow|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590823|NCT00542321|P1|Participant Flow|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590824|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590825|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590826|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590827|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590828|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590829|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590830|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590831|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590832|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590833|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590834|NCT00542321|E2|Reported Event|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
590835|NCT00542321|E1|Reported Event|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
590836|NCT00542308|B1|Baseline|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
590837|NCT00542308|P1|Participant Flow|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
590838|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
590839|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
590840|NCT00542308|E1|Reported Event|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
590841|NCT00542269|B4|Baseline|Total|Total of all reporting groups
590842|NCT00542269|B3|Baseline|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590843|NCT00542269|B2|Baseline|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590886|NCT00542178|P4|Participant Flow|Standard Glycemia Control & Standard Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
590892|NCT00542178|O4|Outcome|Standard Blood Pressure Control|Strategy of BP treatment for SBP less than 140 mmHg
592356|NCT00539110|B2|Baseline|Ramelteon First, Then Zolpidem|dosed at 2200 and 0200 per the feeding tube
590844|NCT00542269|B1|Baseline|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590845|NCT00542269|P3|Participant Flow|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590846|NCT00542269|P2|Participant Flow|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590847|NCT00542269|P1|Participant Flow|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590848|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590849|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590850|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590851|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590852|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590853|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590854|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590887|NCT00542178|P3|Participant Flow|Intensive Glycemia Control & Standard Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
590888|NCT00542178|P2|Participant Flow|Standard Glycemia Control & Intensive Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
590855|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590856|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590857|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590858|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590859|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590860|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590861|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590862|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590863|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590864|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590865|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590889|NCT00542178|P1|Participant Flow|Intensive Glycemia Control & Intensive Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
590890|NCT00542178|O6|Outcome|Placebo + Simvastatin Therapy|Blinded placebo + simvastatin 20-40 mg/d
590891|NCT00542178|O5|Outcome|Fenofibrate + Simvastatin Therapy|Blinded fenofibrate + simvastatin 20-40 mg/d
590866|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590867|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590868|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590869|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590870|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590871|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590872|NCT00542269|E3|Reported Event|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590873|NCT00542269|E2|Reported Event|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590874|NCT00542269|E1|Reported Event|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
590875|NCT00542178|B7|Baseline|Total|Total of all reporting groups
590876|NCT00542178|B6|Baseline|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
590877|NCT00542178|B5|Baseline|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
590878|NCT00542178|B4|Baseline|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
590879|NCT00542178|B3|Baseline|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
590880|NCT00542178|B2|Baseline|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
590881|NCT00542178|B1|Baseline|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
590882|NCT00542178|P8|Participant Flow|Standard Glycemia Control & Fibrate Placebo|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
590883|NCT00542178|P7|Participant Flow|Intensive Glycemia Control & Fibrate Placebo|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
590884|NCT00542178|P6|Participant Flow|Standard Glycemia Control & Fibrate|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
590885|NCT00542178|P5|Participant Flow|Intensive Glycemia Control & Fibrate|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
594668|NCT00534001|B3|Baseline|Total|Total of all reporting groups
590893|NCT00542178|O3|Outcome|Intensive Blood Pressure Control|A strategy of BP treatment for SBP less than 120 mmHg
590894|NCT00542178|O2|Outcome|Standard Glycemia Control|Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
590895|NCT00542178|O1|Outcome|Intensive Glycemia Control|Strategy of intensive glycemia treatment to HbA1c less than 6%
590896|NCT00542178|E6|Reported Event|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
590897|NCT00542178|E5|Reported Event|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
590898|NCT00542178|E4|Reported Event|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
590899|NCT00542178|E3|Reported Event|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
590900|NCT00542178|E2|Reported Event|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
590901|NCT00542178|E1|Reported Event|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
590902|NCT00541970|B5|Baseline|Total|Total of all reporting groups
590903|NCT00541970|B4|Baseline|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590904|NCT00541970|B3|Baseline|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590905|NCT00541970|B2|Baseline|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590906|NCT00541970|B1|Baseline|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590907|NCT00541970|P4|Participant Flow|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590908|NCT00541970|P3|Participant Flow|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590909|NCT00541970|P2|Participant Flow|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590910|NCT00541970|P1|Participant Flow|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590911|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590912|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590913|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590914|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590915|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590916|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590917|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590918|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590919|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590920|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590921|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590922|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590923|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591153|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
590924|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590925|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590926|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590927|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590928|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590929|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590930|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590931|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590932|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590933|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590934|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590935|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590936|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590937|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590938|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590939|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590940|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590941|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590942|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590943|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590944|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590945|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590946|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590947|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590948|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591050|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590949|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590950|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590951|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590952|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590953|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590954|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590955|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590956|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590957|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590958|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590959|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590960|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590961|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590962|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590963|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590964|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590965|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590966|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590967|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590968|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590969|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590970|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590971|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590972|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590973|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591115|NCT00541866|E1|Reported Event|Group 1 (Sch A, 10 to 90 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
590974|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590975|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590976|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590977|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590978|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590979|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590980|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590981|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590982|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590983|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590984|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590985|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590986|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590987|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590988|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590989|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590990|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590991|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590992|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590993|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590994|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590995|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
590996|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590997|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590998|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
590999|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591000|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591001|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591002|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591003|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591004|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591005|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591006|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591007|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591008|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591009|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591010|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591011|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591012|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591013|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591014|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591015|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591016|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591017|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591018|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591019|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591020|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591021|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591022|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591023|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591024|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591116|NCT00541775|B4|Baseline|Total|Total of all reporting groups
591154|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591025|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591026|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591027|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591028|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591029|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591030|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591031|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591032|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591033|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591034|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591035|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591036|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591037|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591038|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591039|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591040|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591041|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591042|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591043|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591044|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591045|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591046|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591047|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591048|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591049|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591152|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591051|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591052|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591053|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591054|NCT00541970|E4|Reported Event|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
591055|NCT00541970|E3|Reported Event|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591056|NCT00541970|E2|Reported Event|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591057|NCT00541970|E1|Reported Event|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
591058|NCT00541931|B3|Baseline|Total|Total of all reporting groups
591059|NCT00541931|B2|Baseline|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
591060|NCT00541931|B1|Baseline|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
591061|NCT00541931|P2|Participant Flow|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
591062|NCT00541931|P1|Participant Flow|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
591063|NCT00541931|O2|Outcome|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
591064|NCT00541931|O1|Outcome|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano: Daily use"
591065|NCT00541931|O2|Outcome|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
591066|NCT00541931|O1|Outcome|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
591067|NCT00541931|E2|Reported Event|Smoker|"Smoker arm Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
591068|NCT00541931|E1|Reported Event|Nonsmoker|"Nonsmokers Intervention: Dietary Supplement: LifePak Nano~Dietary Supplement: LifePak Nano : Daily use"
591069|NCT00541866|B6|Baseline|Total|Total of all reporting groups
591070|NCT00541866|B5|Baseline|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591071|NCT00541866|B4|Baseline|Group 4 (Sch B, First Relapse, 90 mg/m2)|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591072|NCT00541866|B3|Baseline|Group 3 (Sch A, First Relapse, 80 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591073|NCT00541866|B2|Baseline|Group 2 (Sch B, 70 to 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591074|NCT00541866|B1|Baseline|Group 1 (Sch A, 10 to 90 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591075|NCT00541866|P5|Participant Flow|Group 5 (Sch B, Primary Refractory, 90 mg/m2)|Expansion Phase Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
591076|NCT00541866|P4|Participant Flow|Group 4 (Sch B, First Relapse, 90 mg/m2)|Expansion Phase: Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
591077|NCT00541866|P3|Participant Flow|Group 3 (Sch A, First Relapse, 80 mg/m2)|Expansion Phase: Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
591078|NCT00541866|P2|Participant Flow|Group 2 (Sch B, 70 to 90 mg/m2):|Dose Escalation Phase Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591079|NCT00541866|P1|Participant Flow|Group 1 (Sch A, 10 to 90 mg/m2)|Dose Escalation Phase Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591080|NCT00541866|O5|Outcome|Group 5 (Sch B, Primary Refractory, 90 mg/m2)|Expansion Phase Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
591081|NCT00541866|O4|Outcome|Group 4 (Sch B, First Relapse, 90 mg/m2)|Expansion Phase: Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)
591082|NCT00541866|O3|Outcome|Group 3 (Sch A, First Relapse, 80 mg/m2)|Expansion Phase: Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)
591083|NCT00541866|O2|Outcome|Group 2 (Sch B, 70 to 90 mg/m2):|Dose Escalation Phase Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591084|NCT00541866|O1|Outcome|Group 1 (Sch A, 10 to 90 mg/m2)|Dose Escalation Phase Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591085|NCT00541866|O5|Outcome|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591086|NCT00541866|O4|Outcome|Group 4 (Sch B, First Relapse, 90 mg/m2)|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591087|NCT00541866|O3|Outcome|Group 3 (Sch A, First Relapse, 80 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591088|NCT00541866|O2|Outcome|Group 2 (Sch B, 70 to 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591089|NCT00541866|O1|Outcome|Group 1 (Sch A, 10 to 90 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591090|NCT00541866|O5|Outcome|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591091|NCT00541866|O4|Outcome|Group 4 (Sch B, First Relapse, 90 mg/m2)|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591092|NCT00541866|O3|Outcome|Group 3 (Sch A, First Relapse, 80 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591093|NCT00541866|O2|Outcome|Group 2 (Sch B, 70 to 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591094|NCT00541866|O1|Outcome|Group 1 (Sch A, 10 to 90 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591095|NCT00541866|O6|Outcome|Total|5 groups combined
591096|NCT00541866|O5|Outcome|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591097|NCT00541866|O4|Outcome|Group 4 (Sch B, First Relapse, 90 mg/m2)|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591098|NCT00541866|O3|Outcome|Group 3 (Sch A, First Relapse, 80 mg/m2):|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591099|NCT00541866|O2|Outcome|Group 2 (Sch B, 70 to 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591100|NCT00541866|O1|Outcome|Group 1 (Sch A, 10 to 90 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591101|NCT00541866|O10|Outcome|Sch B, Cohort 90mg/m2|Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591102|NCT00541866|O9|Outcome|Sch B, Cohort 80mg/m2|Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591103|NCT00541866|O8|Outcome|Sch B, Cohort 70 mg/m2|Schedule B: vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days).
591104|NCT00541866|O7|Outcome|Sch A, Cohort 90mg/m2|Vosaroxin injection 90 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591105|NCT00541866|O6|Outcome|Sch A, Cohort 80mg/m2|Vosaroxin injection 80 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591106|NCT00541866|O5|Outcome|Sch A, Cohort 70mg/m2|Vosaroxin injection 70 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591107|NCT00541866|O4|Outcome|Sch A, Cohort 50mg/m2|Vosaroxin injection 50 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591108|NCT00541866|O3|Outcome|SchA, Cohort 34mg/m2|Vosaroxin injection 34 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591109|NCT00541866|O2|Outcome|Sch A, Cohort 20mg/m2|Vosaroxin injection 20 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591110|NCT00541866|O1|Outcome|Sch A, Cohort 10mg/m2|Vosaroxin injection 10 mg/m2 on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591111|NCT00541866|E5|Reported Event|Group 5 (Sch B, Primary Refractory, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591112|NCT00541866|E4|Reported Event|Group 4 (Sch B, First Relapse, 90 mg/m2):|Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
591113|NCT00541866|E3|Reported Event|Group 3 (Sch A, First Relapse, 80 mg/m2)|Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour continuous IV [CIV] infusion of 400 mg/m2/day × 5 days)
591114|NCT00541866|E2|Reported Event|Group 2 (Sch B, 70 to 90 mg/m2):|saroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous [IV] infusion of 1 g/m2/day × 5 days)
592150|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
591117|NCT00541775|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
591118|NCT00541775|B2|Baseline|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
591119|NCT00541775|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
591120|NCT00541775|P3|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
591121|NCT00541775|P2|Participant Flow|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
591122|NCT00541775|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
591123|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
591124|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
591125|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
591126|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
591127|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
591128|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
591129|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
591130|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
591131|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
591132|NCT00541775|E3|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
591133|NCT00541775|E2|Reported Event|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
591134|NCT00541775|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
591135|NCT00541671|B3|Baseline|Total|Total of all reporting groups
591136|NCT00541671|B2|Baseline|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
591137|NCT00541671|B1|Baseline|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
591138|NCT00541671|P2|Participant Flow|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
591139|NCT00541671|P1|Participant Flow|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
591140|NCT00541671|O2|Outcome|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
591141|NCT00541671|O1|Outcome|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
591142|NCT00541671|E2|Reported Event|Promethazine|
591143|NCT00541671|E1|Reported Event|Placebo|
591144|NCT00541658|B4|Baseline|Total|Total of all reporting groups
591145|NCT00541658|B3|Baseline|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591146|NCT00541658|B2|Baseline|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591147|NCT00541658|B1|Baseline|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591148|NCT00541658|P3|Participant Flow|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591149|NCT00541658|P2|Participant Flow|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591150|NCT00541658|P1|Participant Flow|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591151|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
595088|NCT00532779|O3|Outcome|Placebo|Placebo
591155|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591156|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591157|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591158|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591159|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591160|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591161|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591162|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591163|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591164|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591165|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591166|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591167|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591168|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591169|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591170|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591171|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591172|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591173|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591174|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591175|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591176|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591177|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591178|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591179|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591180|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591181|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591182|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591183|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591184|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591185|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591186|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591187|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591188|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591189|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591190|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591191|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591192|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591193|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591194|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591195|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591196|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591197|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591198|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591199|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591200|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591201|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591202|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591203|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591204|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591205|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591206|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591207|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591208|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591209|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591210|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591211|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591212|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591213|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591214|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591215|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591216|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591217|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591218|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591219|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591220|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591221|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591222|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591223|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591224|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591225|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591226|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591227|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591228|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591229|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591230|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591231|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591232|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591233|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591234|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591235|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591236|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591237|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591238|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591239|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591240|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591241|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591242|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591243|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591244|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591245|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591246|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591247|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591248|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591249|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591250|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591251|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591252|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591253|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591254|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591255|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591256|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591257|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591258|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591259|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591260|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591261|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591262|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591263|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591264|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591265|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591266|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591267|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591268|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591269|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591270|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591271|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591272|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591273|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591274|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591275|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591276|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591277|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591278|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591279|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591280|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591281|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591282|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591283|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591284|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591285|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591286|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591287|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591288|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591289|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591290|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591291|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591292|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591293|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591294|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591295|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591296|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591297|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591298|NCT00541658|O2|Outcome|35 mg DRFB + DRBB|Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB)
591299|NCT00541658|O1|Outcome|5 mg IRBB|5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years
591300|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591301|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591302|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591303|NCT00541658|E3|Reported Event|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
591304|NCT00541658|E2|Reported Event|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
591305|NCT00541658|E1|Reported Event|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
591306|NCT00541593|B1|Baseline|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
591307|NCT00541593|P1|Participant Flow|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
591308|NCT00541593|O1|Outcome|NOTES Pancreatic Pseudocystgastrostomy Patients|Pancreatic Pseudocystgastrostomy Patients having NOTES procedure
591309|NCT00541593|E1|Reported Event|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
591310|NCT00541450|B3|Baseline|Total|Total of all reporting groups
591311|NCT00541450|B2|Baseline|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
591312|NCT00541450|B1|Baseline|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
591313|NCT00541450|P2|Participant Flow|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
591314|NCT00541450|P1|Participant Flow|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
591315|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
591316|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
591340|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591317|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
591318|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
591319|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
591320|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
591321|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
591322|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
591323|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
591324|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
591325|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
591326|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
591327|NCT00541450|E4|Reported Event|Pioglitazone (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg q.d.~In Phase B (Treatment Week 12 -Week 40), participants were administered 45 mg q.d."
591328|NCT00541450|E3|Reported Event|Sita/Met FDC (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.~In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg b.i.d., which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
591329|NCT00541450|E2|Reported Event|Pioglitazone (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, all participants were up-titrated to 30 mg q.d. pioglitazone.
591330|NCT00541450|E1|Reported Event|Sitagliptin (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.
591331|NCT00541346|B1|Baseline|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591332|NCT00541346|P1|Participant Flow|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591333|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591334|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591335|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591336|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591337|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591338|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591339|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
595318|NCT00531947|B3|Baseline|Total|Total of all reporting groups
591341|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591342|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591343|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591344|NCT00541346|E1|Reported Event|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
591345|NCT00541307|B1|Baseline|Enrolled Subjects|The total number of enrolled subjects.
591346|NCT00541307|P1|Participant Flow|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
591347|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
591348|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
591349|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
591350|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
591351|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
591352|NCT00541307|E1|Reported Event|Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface|Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
591353|NCT00541242|B3|Baseline|Total|Total of all reporting groups
591354|NCT00541242|B2|Baseline|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
591355|NCT00541242|B1|Baseline|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
591356|NCT00541242|P2|Participant Flow|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
591357|NCT00541242|P1|Participant Flow|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
591358|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
591359|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
591360|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
591361|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
591362|NCT00541242|E2|Reported Event|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
591363|NCT00541242|E1|Reported Event|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
591364|NCT00541229|B7|Baseline|Total|Total of all reporting groups
591365|NCT00541229|B6|Baseline|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
591366|NCT00541229|B5|Baseline|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
591367|NCT00541229|B4|Baseline|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
591368|NCT00541229|B3|Baseline|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
591369|NCT00541229|B2|Baseline|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
591370|NCT00541229|B1|Baseline|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
591371|NCT00541229|P6|Participant Flow|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
591372|NCT00541229|P5|Participant Flow|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
591373|NCT00541229|P4|Participant Flow|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
591374|NCT00541229|P3|Participant Flow|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
591375|NCT00541229|P2|Participant Flow|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
591376|NCT00541229|P1|Participant Flow|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
591377|NCT00541229|O3|Outcome|Placebo|Placebo group included the Treatment Period I data from patients randomized to treatment sequence placebo/Sitagliptin 100 mg/Sitagliptin 200 mg and treatment sequence placebo/Sitagliptin 200 mg/Sitagliptin 100 mg.
591378|NCT00541229|O2|Outcome|Sitagliptin 100mg|Sitagliptin 100 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 100 mg/Sitagliptin 200 mg/placebo and treatment sequence Sitagliptin 100 mg/ placebo/ Sitagliptin 200 mg.
591379|NCT00541229|O1|Outcome|Sitagliptin 200mg|Sitagliptin 200 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 200 mg/Sitagliptin 100 mg/placebo and treatment sequence Sitagliptin 200 mg/ placebo/ Sitagliptin 100 mg.
591380|NCT00541229|E3|Reported Event|Placebo|Placebo Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin-matching placebo tablets. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
591381|NCT00541229|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 100 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
591382|NCT00541229|E1|Reported Event|Sitagliptin 200 mg|Sitagliptin 200 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 200 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
591383|NCT00541190|B3|Baseline|Total|Total of all reporting groups
591384|NCT00541190|B2|Baseline|Healthy Controls|Healthy subjects.
591385|NCT00541190|B1|Baseline|Cystic Fibrosis|Cystic fibrosis patients
591386|NCT00541190|P2|Participant Flow|Healthy Controls|Healthy subjects.
591387|NCT00541190|P1|Participant Flow|Cystic Fibrosis|Cystic fibrosis patients
591388|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects.
591389|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients
591390|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
591391|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
591392|NCT00541190|E2|Reported Event|Healthy Controls|Healthy subjects.
591393|NCT00541190|E1|Reported Event|Cystic Fibrosis|Cystic fibrosis patients
591394|NCT00541099|B1|Baseline|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
591395|NCT00541099|P1|Participant Flow|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
591396|NCT00541099|O1|Outcome|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
591397|NCT00541099|O1|Outcome|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
591398|NCT00541099|O1|Outcome|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
591399|NCT00541099|E1|Reported Event|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
591400|NCT00541034|B1|Baseline|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
591401|NCT00541034|P1|Participant Flow|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
591402|NCT00541034|O1|Outcome|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
591403|NCT00541034|E1|Reported Event|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
591404|NCT00540969|B3|Baseline|Total|Total of all reporting groups
591405|NCT00540969|B2|Baseline|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
591442|NCT00540592|B7|Baseline|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591406|NCT00540969|B1|Baseline|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
591407|NCT00540969|P2|Participant Flow|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
591408|NCT00540969|P1|Participant Flow|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
591409|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
591410|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
591411|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
591412|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
591413|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
591414|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
591415|NCT00540969|E2|Reported Event|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
591416|NCT00540969|E1|Reported Event|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
591417|NCT00540722|B1|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591418|NCT00540722|P1|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591419|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591420|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591443|NCT00540592|B6|Baseline|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591444|NCT00540592|B5|Baseline|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591445|NCT00540592|B4|Baseline|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
592357|NCT00539110|B1|Baseline|Zolpidem First, Then Ramelteon|dosed at 2200 and 0200 per the feeding tube
591421|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591422|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591423|NCT00540722|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and o6-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591424|NCT00540722|E1|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|"Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.~R-(-)-gossypol acetic acid: Given PO~laboratory biomarker analysis: Correlative studies"
591425|NCT00540644|B3|Baseline|Total|Total of all reporting groups
591426|NCT00540644|B2|Baseline|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591427|NCT00540644|B1|Baseline|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591428|NCT00540644|P2|Participant Flow|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591429|NCT00540644|P1|Participant Flow|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591430|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591431|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591432|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591433|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591434|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591435|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591436|NCT00540644|E2|Reported Event|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591437|NCT00540644|E1|Reported Event|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
591438|NCT00540592|B11|Baseline|Total|Total of all reporting groups
591439|NCT00540592|B10|Baseline|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591440|NCT00540592|B9|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591441|NCT00540592|B8|Baseline|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591446|NCT00540592|B3|Baseline|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591447|NCT00540592|B2|Baseline|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591448|NCT00540592|B1|Baseline|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591449|NCT00540592|P10|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591450|NCT00540592|P9|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591451|NCT00540592|P8|Participant Flow|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591452|NCT00540592|P7|Participant Flow|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591453|NCT00540592|P6|Participant Flow|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591454|NCT00540592|P5|Participant Flow|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591455|NCT00540592|P4|Participant Flow|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591456|NCT00540592|P3|Participant Flow|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591457|NCT00540592|P2|Participant Flow|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591458|NCT00540592|P1|Participant Flow|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591459|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591460|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591461|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591462|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591463|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591464|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591465|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591466|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591467|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591468|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591469|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591470|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591471|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591472|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591473|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591474|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591475|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591476|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591477|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591478|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591479|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591480|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591481|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591482|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591483|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591484|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
597033|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
591485|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591486|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591487|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591488|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591489|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591490|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591491|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591492|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591493|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591494|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591495|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591496|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591497|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591498|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591499|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591500|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591501|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591502|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591503|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591504|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591505|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591506|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591507|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591508|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591509|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591510|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591511|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591512|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591513|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591514|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591515|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591516|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591517|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591518|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591519|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591520|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591521|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591522|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591523|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591680|NCT00540592|E9|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591524|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591525|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591526|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591527|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591528|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591529|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591530|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591531|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591532|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591533|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591534|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591535|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591536|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591537|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591538|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591539|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591540|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591541|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591542|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591543|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591544|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591545|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591546|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591547|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591548|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591549|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591550|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591551|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591552|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591553|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591554|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591555|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591556|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591557|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591558|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591559|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591560|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591561|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591562|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
592151|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
591563|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591564|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591565|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591566|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591567|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591568|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591569|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591570|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591571|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591572|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591573|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591574|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591575|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591576|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591577|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591578|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591579|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591580|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591581|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591582|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591583|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591584|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591585|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591586|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591587|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591588|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591589|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591590|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591591|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591592|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591593|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591594|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591595|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591596|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591597|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591598|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591599|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591600|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591601|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
592152|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
591602|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591603|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591604|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591605|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591606|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591607|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591608|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591609|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591610|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591611|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591612|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591613|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591614|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591615|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591616|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591617|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591618|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591619|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591620|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591621|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591622|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591623|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591624|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591625|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591626|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591627|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591628|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591629|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591630|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591631|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591632|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591633|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591634|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591635|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591636|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591637|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591638|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591639|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591640|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
592153|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
591641|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591642|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591643|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591644|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591645|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591646|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591647|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591648|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591649|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591650|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591651|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591652|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591653|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591654|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591655|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591656|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591657|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591658|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591659|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591660|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591661|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591662|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591663|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591664|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591665|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591666|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591667|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591668|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591669|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
591670|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
591671|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591672|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591673|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591674|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591675|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591676|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591677|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591678|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591679|NCT00540592|E10|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
592154|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
591681|NCT00540592|E8|Reported Event|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
591682|NCT00540592|E7|Reported Event|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
591683|NCT00540592|E6|Reported Event|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
591684|NCT00540592|E5|Reported Event|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
591685|NCT00540592|E4|Reported Event|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
591686|NCT00540592|E3|Reported Event|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
591687|NCT00540592|E2|Reported Event|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
591688|NCT00540592|E1|Reported Event|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
591689|NCT00540579|B1|Baseline|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
591690|NCT00540579|P1|Participant Flow|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
591691|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
591692|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
591693|NCT00540579|E1|Reported Event|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
591694|NCT00540514|B3|Baseline|Total|Total of all reporting groups
591695|NCT00540514|B2|Baseline|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591696|NCT00540514|B1|Baseline|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591697|NCT00540514|P2|Participant Flow|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591698|NCT00540514|P1|Participant Flow|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591699|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591700|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591701|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591702|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591703|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591757|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
592155|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
591704|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591705|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591706|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591707|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591708|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591709|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591710|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591711|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591712|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591713|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591714|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591715|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591716|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591717|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591718|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591758|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
592156|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
591719|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591720|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591721|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591722|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591723|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591724|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591725|NCT00540514|E2|Reported Event|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591726|NCT00540514|E1|Reported Event|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
591727|NCT00540449|B3|Baseline|Total|Total of all reporting groups
591728|NCT00540449|B2|Baseline|Efavirenz|600 mg once daily for 96 weeks.
591729|NCT00540449|B1|Baseline|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591730|NCT00540449|P2|Participant Flow|Efavirenz|600 mg once daily for 96 weeks.
591731|NCT00540449|P1|Participant Flow|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591732|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591733|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591734|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591735|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591736|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591737|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591738|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591739|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591740|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591741|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591742|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591743|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591744|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591745|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591746|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591747|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591748|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
591749|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591750|NCT00540449|E2|Reported Event|Efavirenz|600 mg once daily for 96 weeks.
591751|NCT00540449|E1|Reported Event|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
591752|NCT00540436|B1|Baseline|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
591753|NCT00540436|P1|Participant Flow|GSK1325760A|First Treatment Period: GSK1325760A 5 mg once a day. Second Treatment Period: GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
591754|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591755|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591756|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591759|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591760|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591761|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591762|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591763|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
591764|NCT00540436|E1|Reported Event|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
591765|NCT00540423|B3|Baseline|Total|Total of all reporting groups
591766|NCT00540423|B2|Baseline|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591767|NCT00540423|B1|Baseline|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591768|NCT00540423|P3|Participant Flow|SB-497115-GR, Open-label|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count.
591769|NCT00540423|P2|Participant Flow|SB-497115-GR, Double-blind|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7.
591770|NCT00540423|P1|Participant Flow|Placebo|Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7
591771|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB497511-GR on the PK sampling day
591772|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
591773|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
591774|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
591775|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB497511-GR on the PK sampling day
591776|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
591777|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
591778|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
591779|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
591780|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
591781|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
591782|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
591783|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
591784|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
591785|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
591786|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
591787|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
591788|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
591789|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
591790|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
591791|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
591792|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591793|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591794|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591795|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591796|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591797|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591798|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591799|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591800|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591801|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591802|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591803|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591804|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591805|NCT00540423|O2|Outcome|SG-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591806|NCT00540423|O1|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591807|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591808|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591809|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591810|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591811|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
591812|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591813|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591814|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591815|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591816|NCT00540423|E3|Reported Event|SB-497115-GR Long-Term Phase|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count
591817|NCT00540423|E2|Reported Event|SB-497115-GR Short-Term (Double-Blind) Phase|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591818|NCT00540423|E1|Reported Event|Placebo Short-Term (Double-Blind) Phase|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
591819|NCT00540293|B1|Baseline|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
591820|NCT00540293|P1|Participant Flow|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
591821|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591822|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591823|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591824|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591825|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591826|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591827|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591828|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591829|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591830|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591831|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591832|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591833|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591834|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591987|NCT00540046|B3|Baseline|Total|Total of all reporting groups
592157|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
591835|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591836|NCT00540293|O1|Outcome|Total|N=425 (Total: sum of all risk groups)
591837|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591838|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591839|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591840|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591841|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591842|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591843|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591844|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591845|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591846|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591847|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591848|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591849|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591850|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591851|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591852|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591853|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591854|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591855|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591856|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591857|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
591858|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
591859|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
591860|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
591861|NCT00540293|E1|Reported Event|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
591862|NCT00540228|B6|Baseline|Total|Total of all reporting groups
591863|NCT00540228|B5|Baseline|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591864|NCT00540228|B4|Baseline|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591865|NCT00540228|B3|Baseline|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591866|NCT00540228|B2|Baseline|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591867|NCT00540228|B1|Baseline|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591868|NCT00540228|P5|Participant Flow|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591869|NCT00540228|P4|Participant Flow|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591870|NCT00540228|P3|Participant Flow|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
592061|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
591871|NCT00540228|P2|Participant Flow|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591872|NCT00540228|P1|Participant Flow|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591873|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591874|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591875|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591876|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591877|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591878|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591879|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591880|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591881|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591882|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591883|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591884|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591885|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591886|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591887|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591888|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591889|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591890|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591891|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591892|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591893|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591894|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591895|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591896|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591897|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
592062|NCT00539994|E3|Reported Event|Placebo|Placebo 200 mg BID for 5 days
592063|NCT00539994|E2|Reported Event|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
591898|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591899|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591900|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591901|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591902|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591903|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591904|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591905|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591906|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591907|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591908|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591909|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591910|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591911|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591912|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591913|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591914|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591915|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591916|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591917|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591918|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591919|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591920|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591921|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591922|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591923|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591924|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591925|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591926|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591927|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591928|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591929|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591930|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591931|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591932|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591933|NCT00540228|E5|Reported Event|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591934|NCT00540228|E4|Reported Event|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591935|NCT00540228|E3|Reported Event|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591936|NCT00540228|E2|Reported Event|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591937|NCT00540228|E1|Reported Event|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
591938|NCT00540124|B4|Baseline|Total|Total of all reporting groups
591939|NCT00540124|B3|Baseline|Tamsulosin|0.2 mg by mouth once a day
591940|NCT00540124|B2|Baseline|Tadalafil|5 mg by mouth once a day
591941|NCT00540124|B1|Baseline|Placebo|by mouth once a day
591942|NCT00540124|P3|Participant Flow|Tamsulosin|0.2 mg by mouth once a day
591943|NCT00540124|P2|Participant Flow|Tadalafil|5 mg by mouth once a day
591944|NCT00540124|P1|Participant Flow|Placebo|by mouth once a day
591945|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591946|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591947|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591948|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591949|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591950|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591951|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591952|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591953|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591954|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591955|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591956|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591957|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591958|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591959|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591960|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591961|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591962|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591963|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591964|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591965|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591966|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591967|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591968|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591969|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591970|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591971|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591972|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591973|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591974|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591975|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591976|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591977|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591978|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591979|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591980|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591981|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
591982|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
591983|NCT00540124|O1|Outcome|Placebo|by mouth once a day
591984|NCT00540124|E3|Reported Event|Tamsulosin|0.2 mg by mouth once a day
591985|NCT00540124|E2|Reported Event|Tadalafil|5 mg by mouth once a day
591986|NCT00540124|E1|Reported Event|Placebo|by mouth once a day
591988|NCT00540046|B2|Baseline|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
591989|NCT00540046|B1|Baseline|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
591990|NCT00540046|P2|Participant Flow|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
591991|NCT00540046|P1|Participant Flow|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
591992|NCT00540046|O2|Outcome|B/Delayed|"The delayed group had the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~IUD status was known six months post-abortion."
591993|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm had the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure.~IUD status was known six months post-abortion and insertion."
591994|NCT00540046|O2|Outcome|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
591995|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
591996|NCT00540046|E2|Reported Event|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
591997|NCT00540046|E1|Reported Event|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
591998|NCT00540007|B3|Baseline|Total|Total of all reporting groups
591999|NCT00540007|B2|Baseline|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592000|NCT00540007|B1|Baseline|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592001|NCT00540007|P2|Participant Flow|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592002|NCT00540007|P1|Participant Flow|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592003|NCT00540007|O2|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592004|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592005|NCT00540007|O2|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592006|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592007|NCT00540007|O2|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592008|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592009|NCT00540007|O2|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592010|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592011|NCT00540007|O2|Outcome|Cohort 2|Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
592012|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592064|NCT00539994|E1|Reported Event|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592065|NCT00539942|B3|Baseline|Total|Total of all reporting groups
592013|NCT00540007|O2|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592014|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592015|NCT00540007|O2|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592016|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592017|NCT00540007|O2|Outcome|Cohort 2|Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
592018|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592019|NCT00540007|O2|Outcome|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592020|NCT00540007|O1|Outcome|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592021|NCT00540007|E2|Reported Event|Cohort 2 - Lenalidomide Daily on Days 1-28|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle."
592022|NCT00540007|E1|Reported Event|Cohort 1 - Lenalidomide Daily on Days 1-21|"The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2~Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle."
592023|NCT00539994|B4|Baseline|Total|Total of all reporting groups
592024|NCT00539994|B3|Baseline|Placebo|Placebo 200 mg BID for 5 days
592025|NCT00539994|B2|Baseline|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592026|NCT00539994|B1|Baseline|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592027|NCT00539994|P3|Participant Flow|Placebo|Placebo 200 mg BID for 5 days
592028|NCT00539994|P2|Participant Flow|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592029|NCT00539994|P1|Participant Flow|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592030|NCT00539994|O4|Outcome|Total|Total of all groups
592031|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
592032|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592033|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592034|NCT00539994|O1|Outcome|MRSA|Methicillin Resistant S. aureus.
592035|NCT00539994|O2|Outcome|Positive Pharyngeal Culture for S. Aureus|Subjects who tested positive for S. aureus in the pharyngeal region.
592036|NCT00539994|O1|Outcome|Positive Nasal Culture for S. Aureus|Screened subjects positive for S. aureus
592037|NCT00539994|O4|Outcome|Total|Total of all Groups
592038|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
592039|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592040|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 Days and Placebo 2 days
592041|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
592042|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592043|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592044|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
592045|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592046|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592047|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592048|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
592049|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592050|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
592051|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
592052|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592053|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592054|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592055|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
592056|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592057|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
592058|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592059|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
592060|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
592066|NCT00539942|B2|Baseline|Fondaparinux (Arixtra)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
592067|NCT00539942|B1|Baseline|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
592068|NCT00539942|P2|Participant Flow|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
592069|NCT00539942|P1|Participant Flow|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
592070|NCT00539942|O2|Outcome|Arixtra (Fondaparinux Sodium)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
592071|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
592072|NCT00539942|O2|Outcome|Arixtra (Fondaparinux Sodium)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
592073|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
592074|NCT00539942|E2|Reported Event|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
592075|NCT00539942|E1|Reported Event|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
592076|NCT00539864|B3|Baseline|Total|Total of all reporting groups
592077|NCT00539864|B2|Baseline|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
592078|NCT00539864|B1|Baseline|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
592079|NCT00539864|P2|Participant Flow|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
592080|NCT00539864|P1|Participant Flow|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
592081|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
592082|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
592083|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
592084|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
592085|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
592086|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
592087|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
592141|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
592088|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
592089|NCT00539864|E2|Reported Event|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
592090|NCT00539864|E1|Reported Event|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
592091|NCT00539734|B1|Baseline|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
592092|NCT00539734|P1|Participant Flow|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
592093|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
592094|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
592095|NCT00539734|E1|Reported Event|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
592096|NCT00539695|B1|Baseline|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
592097|NCT00539695|P1|Participant Flow|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
592098|NCT00539695|O1|Outcome|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
592099|NCT00539695|O1|Outcome|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
592100|NCT00539695|O1|Outcome|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
592142|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
592143|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592144|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592101|NCT00539695|E1|Reported Event|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
592102|NCT00539617|B1|Baseline|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
592103|NCT00539617|P1|Participant Flow|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
592104|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
592105|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
592106|NCT00539617|E1|Reported Event|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
592107|NCT00539591|B4|Baseline|Total|Total of all reporting groups
592108|NCT00539591|B3|Baseline|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
592109|NCT00539591|B2|Baseline|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
592110|NCT00539591|B1|Baseline|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
592111|NCT00539591|P3|Participant Flow|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
592112|NCT00539591|P2|Participant Flow|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
592113|NCT00539591|P1|Participant Flow|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
592114|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592115|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592116|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
592117|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
592118|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
592119|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592120|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592121|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
592122|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
592123|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
592124|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592125|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592126|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
592127|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
592128|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
592129|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592130|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592131|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
592132|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
592133|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
592134|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
592135|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592136|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592137|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
592138|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
592139|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
592140|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
592158|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
592159|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592160|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592161|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
592162|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
592163|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
592164|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
592165|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
592166|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
592167|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592168|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592169|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
592170|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
592171|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
592172|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
592173|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
592174|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
592175|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
592176|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592177|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592178|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
592179|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
592180|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
592181|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
592182|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
592183|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
592184|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
592185|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592186|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592187|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
592188|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
592189|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
592190|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
592191|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
592192|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
592193|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
592194|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
592195|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
592196|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
592197|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
592198|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
592199|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
592200|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
592201|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
592202|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
592203|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
592204|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
592205|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
592206|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
592207|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
592208|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
592209|NCT00539591|O2|Outcome|Week 28 - Steady State|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed.
592210|NCT00539591|O1|Outcome|Week 5 - First Dose|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
592211|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
592212|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
592213|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
592562|NCT00538642|E2|Reported Event|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592214|NCT00539591|O2|Outcome|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
592215|NCT00539591|O1|Outcome|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
592216|NCT00539591|O1|Outcome|Stratum B1|"Stratum B: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants, divided into 2 groups based on presence (B1) or absence (B2) of measurable disease~Stratum B1 had presence of measurable disease. Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.~Interventions: Temozolomide, peginterferon ɑ-2b"
592217|NCT00539591|E3|Reported Event|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
592218|NCT00539591|E2|Reported Event|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
592219|NCT00539591|E1|Reported Event|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
592220|NCT00539539|B3|Baseline|Total|Total of all reporting groups
592221|NCT00539539|B2|Baseline|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592222|NCT00539539|B1|Baseline|Feedback On|Automated real-time feedback on CPR Process activated
592223|NCT00539539|P2|Participant Flow|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592224|NCT00539539|P1|Participant Flow|Feedback On|Automated real-time feedback on CPR Process activated
592225|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592226|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592227|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592228|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592229|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592230|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592231|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592232|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592271|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
592563|NCT00538642|E1|Reported Event|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592233|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592234|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592235|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592236|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592237|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592238|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592239|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592240|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
592241|NCT00539539|E2|Reported Event|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
592242|NCT00539539|E1|Reported Event|Feedback On|Automated real-time feedback on CPR Process activated
592243|NCT00539526|B4|Baseline|Total|Total of all reporting groups
592244|NCT00539526|B3|Baseline|Latanoprost 0.005%|latanoprost 0.005%
592245|NCT00539526|B2|Baseline|Travoprost 0.004%|travoprost 0.004%
592246|NCT00539526|B1|Baseline|Bimatoprost 0.03%|bimatoprost 0.03%
592247|NCT00539526|P3|Participant Flow|Latanoprost 0.005%|latanoprost 0.005%
592248|NCT00539526|P2|Participant Flow|Travoprost 0.004%|travoprost 0.004%
592249|NCT00539526|P1|Participant Flow|Bimatoprost 0.03%|bimatoprost 0.03%
592250|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
592251|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
592252|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
592253|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
592254|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
592255|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
592256|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
592257|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
592258|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
592259|NCT00539526|E3|Reported Event|Latanoprost 0.005%|latanoprost 0.005%
592260|NCT00539526|E2|Reported Event|Travoprost 0.004%|travoprost 0.004%
592261|NCT00539526|E1|Reported Event|Bimatoprost 0.03%|bimatoprost 0.03%
592262|NCT00539513|B3|Baseline|Total|Total of all reporting groups
592263|NCT00539513|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
592264|NCT00539513|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
592265|NCT00539513|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
592266|NCT00539513|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
592267|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
592268|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
592269|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
592270|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
592272|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
592273|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
592274|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
592275|NCT00539513|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
592276|NCT00539513|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
592277|NCT00539305|B3|Baseline|Total|Total of all reporting groups
592278|NCT00539305|B2|Baseline|Placebo Group|Placebo gel : applied topically daily for six months
592279|NCT00539305|B1|Baseline|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
592280|NCT00539305|P2|Participant Flow|Placebo Group|Placebo gel : applied topically daily for six months
592281|NCT00539305|P1|Participant Flow|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
592282|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
592283|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
592284|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
592285|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
592286|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
592287|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
592288|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
592289|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
592290|NCT00539305|E2|Reported Event|Placebo Group|Placebo gel : applied topically daily for six months
592291|NCT00539305|E1|Reported Event|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
592292|NCT00539279|B3|Baseline|Total|Total of all reporting groups
592293|NCT00539279|B2|Baseline|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592294|NCT00539279|B1|Baseline|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592295|NCT00539279|P2|Participant Flow|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592296|NCT00539279|P1|Participant Flow|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592297|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592298|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592299|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592300|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592301|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592302|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592303|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
597034|NCT00529087|O3|Outcome|Placebo|Once daily
592304|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592305|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592306|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592307|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592308|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592309|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592310|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592311|NCT00539279|E2|Reported Event|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
592312|NCT00539279|E1|Reported Event|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
592313|NCT00539253|B1|Baseline|Gadobenate Dimeglumine (Multi Hance)|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies."
592314|NCT00539253|P1|Participant Flow|Gadabenate Dimeglumine( Multihance)|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MRI imaging for both the baseline and 1 month f/u studies."
592315|NCT00539253|O1|Outcome|Multihance|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies."
592316|NCT00539253|O1|Outcome|Multihance|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies."
592317|NCT00539253|E1|Reported Event|Gadobenate Dimeglumine (Multi Hance)|"If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study~gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies."
592318|NCT00539240|B4|Baseline|Total|Total of all reporting groups
592319|NCT00539240|B3|Baseline|AcipHex 20 mg Once, Placebo Once, Nortriptyline|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
592320|NCT00539240|B2|Baseline|AcipHex 20 mg Once Daily and BID Placebo|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
592321|NCT00539240|B1|Baseline|AciPhex 20 mg BID and Once Daily Placebo|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
592322|NCT00539240|P3|Participant Flow|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
592323|NCT00539240|P2|Participant Flow|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
592324|NCT00539240|P1|Participant Flow|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
592325|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
592326|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
592327|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
597332|NCT00528801|B3|Baseline|Total|Total of all reporting groups
592328|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
592329|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
592330|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
592331|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
592332|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
592333|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
592334|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
592335|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
592336|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
592337|NCT00539240|E3|Reported Event|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
592338|NCT00539240|E2|Reported Event|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
592339|NCT00539240|E1|Reported Event|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
592340|NCT00539188|B3|Baseline|Total|Total of all reporting groups
592341|NCT00539188|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
592342|NCT00539188|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
592343|NCT00539188|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
592344|NCT00539188|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
592345|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
592346|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
592347|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
592348|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
592349|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
592350|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
592351|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
592352|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
592353|NCT00539188|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
592354|NCT00539188|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
592355|NCT00539110|B3|Baseline|Total|Total of all reporting groups
592358|NCT00539110|P2|Participant Flow|Ramelteon, Then Zolpidem|"medication dosed at 2200 and 0200 per the feeding tube~washout with no sleep meds (x3 nights); ramelteon (x4 nights); washout (x3 nights); then zolpidem (x 4 nights)"
592359|NCT00539110|P1|Participant Flow|Zolpidem First, Then Ramelteon|"medication dosed at 2200 and 0200 per feeding tube~washout with no sleep meds (3 nights); zolpidem (x4 nights); washout (x3 nights); then ramelteon (x4 nights)"
592360|NCT00539110|O2|Outcome|Ramelteon|dosed at 2200 and 0200 per the feeding tube
592361|NCT00539110|O1|Outcome|Zolpidem|medication dosed at 2200 and 0200 per feeding tube
592362|NCT00539110|E2|Reported Event|Ramelteon|"dosed at 2200 and 0200 per the feeding tube~ramelteon: medication dosed at 2200 and 0200 per feeding tube"
592363|NCT00539110|E1|Reported Event|Zolpidem|"medication dosed at 2200 and 0200 per feeding tube~zolipidem: dosed at 2200 and 0200 per feeding tube"
592364|NCT00539032|B3|Baseline|Total|Total of all reporting groups
592365|NCT00539032|B2|Baseline|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
592366|NCT00539032|B1|Baseline|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
592367|NCT00539032|P2|Participant Flow|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
592368|NCT00539032|P1|Participant Flow|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
592369|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
592370|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
592371|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
592372|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
592373|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
592374|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
592375|NCT00539032|E2|Reported Event|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
592376|NCT00539032|E1|Reported Event|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
592377|NCT00539006|B5|Baseline|Total|Total of all reporting groups
592378|NCT00539006|B4|Baseline|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
592379|NCT00539006|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592380|NCT00539006|B2|Baseline|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
592381|NCT00539006|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592382|NCT00539006|P4|Participant Flow|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
592383|NCT00539006|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592384|NCT00539006|P2|Participant Flow|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
592385|NCT00539006|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592386|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
592387|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592388|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
597512|NCT00528411|B4|Baseline|Total|Total of all reporting groups
592389|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592390|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
592391|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592392|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
592393|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592394|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
592395|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592396|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592397|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
592398|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592399|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS)110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592400|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
592401|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592402|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
592403|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592404|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
592405|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592406|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592407|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
592408|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
592409|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
592410|NCT00539006|E4|Reported Event|Placebo - FP|Subjects who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
592411|NCT00539006|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
592412|NCT00539006|E2|Reported Event|Fluticason Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
592413|NCT00539006|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
592422|NCT00538915|B1|Baseline|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
592423|NCT00538915|P1|Participant Flow|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
592564|NCT00538629|B1|Baseline|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592414|NCT00538980|B1|Baseline|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592415|NCT00538980|P1|Participant Flow|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592416|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592417|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592418|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592419|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592420|NCT00538980|O1|Outcome|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592421|NCT00538980|E1|Reported Event|All Patients|"Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).~Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day)."
592553|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592424|NCT00538915|O1|Outcome|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg administered intravenously every 3 or 4 weeks for approximately 1 year.
592425|NCT00538915|E1|Reported Event|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
592426|NCT00538902|B4|Baseline|Total|Total of all reporting groups
592427|NCT00538902|B3|Baseline|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592428|NCT00538902|B2|Baseline|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
592429|NCT00538902|B1|Baseline|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592430|NCT00538902|P3|Participant Flow|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
592431|NCT00538902|P2|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
592432|NCT00538902|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
592433|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592434|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592435|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592436|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
592437|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592438|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592439|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592440|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
592441|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592442|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592443|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592444|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592445|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592446|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
592447|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592448|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592449|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592450|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592451|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
592452|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592453|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592454|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592455|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
592456|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592457|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
592458|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592459|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592460|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
592461|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
592462|NCT00538902|E4|Reported Event|Any Adalimumab|Any adalimumab exposure during the entire study, whether from Double-Blind or Open-Label treatment.
592463|NCT00538902|E3|Reported Event|DB Phase - Adalimumab 80 mg EOW|Adalimumab 80 mg administered subcutaneously every other week during Double-Blind treatment.
592464|NCT00538902|E2|Reported Event|DB Phase - Adalimumab 40 mg EOW|Adalimumab 40 mg administered subcutaneously every other week during Double-Blind treatment.
592465|NCT00538902|E1|Reported Event|DB Phase - Placebo EOW|Placebo administered subcutaneously every other week during Double-Blind treatment.
592554|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592555|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592466|NCT00538863|B1|Baseline|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
592467|NCT00538863|P1|Participant Flow|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
592468|NCT00538863|O2|Outcome|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
592469|NCT00538863|O1|Outcome|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
592470|NCT00538863|E2|Reported Event|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
592471|NCT00538863|E1|Reported Event|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
592472|NCT00538850|B1|Baseline|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592473|NCT00538850|P3|Participant Flow|Placebo - Double-blind|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592474|NCT00538850|P2|Participant Flow|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592475|NCT00538850|P1|Participant Flow|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
592476|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592477|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592478|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592479|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592480|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592481|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592482|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592483|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592556|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592484|NCT00538850|E2|Reported Event|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
592485|NCT00538850|E1|Reported Event|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
592486|NCT00538824|B1|Baseline|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
592487|NCT00538824|P1|Participant Flow|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
592488|NCT00538824|O1|Outcome|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
592489|NCT00538824|E1|Reported Event|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
592490|NCT00538785|B3|Baseline|Total|Total of all reporting groups
592491|NCT00538785|B2|Baseline|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592492|NCT00538785|B1|Baseline|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592493|NCT00538785|P2|Participant Flow|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592494|NCT00538785|P1|Participant Flow|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592495|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592557|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592558|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592496|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592497|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592498|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592499|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592500|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592501|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592502|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592503|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592504|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592505|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592506|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592507|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592508|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592509|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592510|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592559|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592560|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592561|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592511|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592512|NCT00538785|E2|Reported Event|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592513|NCT00538785|E1|Reported Event|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
592514|NCT00538733|B1|Baseline|T-BiRD Therapy (All Patients)|All patients that enrolled on the study and received treatment with T-BiRD are included in this analysis.
592515|NCT00538733|P1|Participant Flow|T-BiRD Therapy (All Patients)|26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant).
592516|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|25 of the 26 patients enrolled onto the were assessed for progression, as one patient expired prior to first response assessment and could not be included in the analysis.
592517|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|All 26 patients that were enrolled onto the study were assessed for event free survival.
592518|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|25 of the 26 patients enrolled onto the were assessed for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
592519|NCT00538733|O1|Outcome|T-BiRD Therapy (All Patients)|26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant). 25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
592520|NCT00538733|E1|Reported Event|T-BiRD Therapy (All Patients)|All 26 patients that were enrolled onto the study were assessed for adverse events.
592521|NCT00538642|B3|Baseline|Total|Total of all reporting groups
592522|NCT00538642|B2|Baseline|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592523|NCT00538642|B1|Baseline|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592524|NCT00538642|P2|Participant Flow|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592525|NCT00538642|P1|Participant Flow|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592526|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592527|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592528|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592529|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592530|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592531|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592532|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592533|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592534|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592535|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592536|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592537|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592538|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592539|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592540|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592541|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592542|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592543|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592544|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592545|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592546|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592547|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592548|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592549|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592550|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592551|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
592552|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
592565|NCT00538629|P1|Participant Flow|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592566|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592567|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592568|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592569|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592570|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592571|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592572|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592573|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592574|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592575|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592576|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592577|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592578|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592579|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592580|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592581|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592582|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592583|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592584|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592585|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592586|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592587|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592588|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592589|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592590|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592591|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592592|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592593|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592594|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592595|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592596|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592597|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592598|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592599|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592600|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592601|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592602|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592603|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592604|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592605|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592606|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592607|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592608|NCT00538629|E1|Reported Event|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
592609|NCT00538616|B3|Baseline|Total|Total of all reporting groups
592610|NCT00538616|B2|Baseline|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
592611|NCT00538616|B1|Baseline|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
592612|NCT00538616|P2|Participant Flow|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
592613|NCT00538616|P1|Participant Flow|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
592614|NCT00538616|O2|Outcome|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
592615|NCT00538616|O1|Outcome|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
592616|NCT00538616|E2|Reported Event|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
592617|NCT00538616|E1|Reported Event|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
592618|NCT00538590|B3|Baseline|Total|Total of all reporting groups
592619|NCT00538590|B2|Baseline|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592620|NCT00538590|B1|Baseline|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592621|NCT00538590|P2|Participant Flow|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592622|NCT00538590|P1|Participant Flow|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592623|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592624|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592625|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592626|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592627|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592628|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592629|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592630|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592631|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592632|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592633|NCT00538590|E2|Reported Event|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
592634|NCT00538590|E1|Reported Event|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
592635|NCT00538512|B4|Baseline|Total|Total of all reporting groups
592636|NCT00538512|B3|Baseline|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
592637|NCT00538512|B2|Baseline|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
592638|NCT00538512|B1|Baseline|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
592639|NCT00538512|P3|Participant Flow|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
592640|NCT00538512|P2|Participant Flow|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
592641|NCT00538512|P1|Participant Flow|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
592642|NCT00538512|O3|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
592643|NCT00538512|O2|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
592644|NCT00538512|O1|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
592645|NCT00538512|O3|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
592646|NCT00538512|O2|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
592647|NCT00538512|O1|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
592648|NCT00538512|O3|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
592649|NCT00538512|O2|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
592650|NCT00538512|O1|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
592651|NCT00538512|O3|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
592652|NCT00538512|O2|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
592653|NCT00538512|O1|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
592654|NCT00538512|E3|Reported Event|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
592655|NCT00538512|E2|Reported Event|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
592656|NCT00538512|E1|Reported Event|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
592657|NCT00538473|B3|Baseline|Total|Total of all reporting groups
592658|NCT00538473|B2|Baseline|Fluarix Group|Subjects received 1 dose of Fluarix™.
592659|NCT00538473|B1|Baseline|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592660|NCT00538473|P2|Participant Flow|Fluarix Group|Subjects received 1 dose of Fluarix™.
592661|NCT00538473|P1|Participant Flow|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592662|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592663|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592664|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592665|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592666|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592667|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592668|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592669|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592670|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592671|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592672|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592673|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592674|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592675|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592676|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592677|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592678|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592679|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592680|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592681|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592682|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592683|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592684|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592685|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592686|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592687|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592688|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
592689|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592690|NCT00538473|E2|Reported Event|Fluarix Group|Subjects received 1 dose of Fluarix™.
592691|NCT00538473|E1|Reported Event|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
592692|NCT00538434|B5|Baseline|Total|Total of all reporting groups
592693|NCT00538434|B4|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592694|NCT00538434|B3|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592695|NCT00538434|B2|Baseline|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592696|NCT00538434|B1|Baseline|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592697|NCT00538434|P4|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592698|NCT00538434|P3|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592699|NCT00538434|P2|Participant Flow|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592700|NCT00538434|P1|Participant Flow|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592701|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592702|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592703|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592704|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592705|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592706|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592707|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592708|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592709|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592710|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592711|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592712|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592713|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592714|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592715|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592716|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592717|NCT00538434|E4|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592718|NCT00538434|E3|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592719|NCT00538434|E2|Reported Event|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592720|NCT00538434|E1|Reported Event|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
592721|NCT00538304|B3|Baseline|Total|Total of all reporting groups
592722|NCT00538304|B2|Baseline|Placebo|Placebo
592723|NCT00538304|B1|Baseline|Bimatoprost Eye Drops|Bimatoprost eye drops
592724|NCT00538304|P2|Participant Flow|Placebo|Placebo
592725|NCT00538304|P1|Participant Flow|Bimatoprost Eye Drops|Bimatoprost eye drops
592726|NCT00538304|O2|Outcome|Placebo|Placebo
592727|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
592728|NCT00538304|O2|Outcome|Placebo|Placebo
592729|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
592730|NCT00538304|O2|Outcome|Placebo|Placebo
592731|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
592732|NCT00538304|O2|Outcome|Placebo|Placebo
592733|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
592734|NCT00538304|O2|Outcome|Placebo|Placebo
592735|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
592736|NCT00538304|O2|Outcome|Placebo|Placebo
592737|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
592738|NCT00538304|E2|Reported Event|Placebo|Placebo
592739|NCT00538304|E1|Reported Event|Bimatoprost Eye Drops|Bimatoprost eye drops
592740|NCT00538291|B1|Baseline|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
592741|NCT00538291|P1|Participant Flow|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
592742|NCT00538291|O1|Outcome|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
592743|NCT00538291|E1|Reported Event|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
592744|NCT00538213|B4|Baseline|Total|Total of all reporting groups
592745|NCT00538213|B3|Baseline|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592746|NCT00538213|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592747|NCT00538213|B1|Baseline|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592748|NCT00538213|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592749|NCT00538213|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592750|NCT00538213|P1|Participant Flow|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592751|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592752|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592753|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592754|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592755|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592756|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592757|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592758|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592759|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592760|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
593280|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
592761|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592762|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592763|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592764|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592765|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592766|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592767|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592768|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592769|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592770|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592771|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592772|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592773|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592774|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592775|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592776|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592777|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592778|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592779|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592780|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592781|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592782|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592783|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592784|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592785|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592786|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592787|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592788|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592789|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592790|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
597998|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
592791|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592792|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
592793|NCT00538213|E3|Reported Event|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592794|NCT00538213|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
592795|NCT00538213|E1|Reported Event|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
592796|NCT00537979|B3|Baseline|Total|Total of all reporting groups
592797|NCT00537979|B2|Baseline|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
592798|NCT00537979|B1|Baseline|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
592799|NCT00537979|P2|Participant Flow|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
592800|NCT00537979|P1|Participant Flow|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
592801|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
592802|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
592803|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
592804|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
592805|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
592806|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
592807|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
592808|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
592809|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
592810|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
592811|NCT00537979|E2|Reported Event|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
592812|NCT00537979|E1|Reported Event|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
592813|NCT00537940|B3|Baseline|Total|Total of all reporting groups
592814|NCT00537940|B2|Baseline|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592815|NCT00537940|B1|Baseline|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592816|NCT00537940|P2|Participant Flow|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
601177|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
592817|NCT00537940|P1|Participant Flow|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592818|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592819|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592820|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592821|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592822|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592823|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592824|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592869|NCT00537810|P3|Participant Flow|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
592870|NCT00537810|P2|Participant Flow|Placebo|"Placebo Daily~Placebo: Daily"
592825|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592826|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592827|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592828|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592829|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592830|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592831|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592832|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592871|NCT00537810|P1|Participant Flow|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
592872|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
592833|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592834|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592835|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592836|NCT00537940|E2|Reported Event|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
592837|NCT00537940|E1|Reported Event|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
592838|NCT00537823|B3|Baseline|Total|Total of all reporting groups
592839|NCT00537823|B2|Baseline|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
592840|NCT00537823|B1|Baseline|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
592841|NCT00537823|P2|Participant Flow|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
592842|NCT00537823|P1|Participant Flow|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
592873|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
592843|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592844|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592845|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592846|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592847|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592848|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592849|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592850|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592851|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592852|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592853|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592854|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592855|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592856|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592857|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592858|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592859|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592860|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592861|NCT00537823|E2|Reported Event|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
592862|NCT00537823|E1|Reported Event|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
592863|NCT00537810|B5|Baseline|Total|Total of all reporting groups
592864|NCT00537810|B4|Baseline|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
592865|NCT00537810|B3|Baseline|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
592866|NCT00537810|B2|Baseline|Placebo|"Placebo Daily~Placebo: Daily"
592867|NCT00537810|B1|Baseline|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
592868|NCT00537810|P4|Participant Flow|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
592874|NCT00537810|O2|Outcome|Placebo|"Placebo Daily~Placebo: Daily"
592875|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
592876|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
592877|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
592878|NCT00537810|O2|Outcome|Placebo|"Placebo Daily~Placebo: Daily"
592879|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
592880|NCT00537810|E4|Reported Event|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
592881|NCT00537810|E3|Reported Event|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
592882|NCT00537810|E2|Reported Event|Placebo|"Placebo Daily~Placebo: Daily"
592883|NCT00537810|E1|Reported Event|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
592884|NCT00537771|B3|Baseline|Total|Total of all reporting groups
592885|NCT00537771|B2|Baseline|TAM Group|Tamoxifen : 20 mg once daily oral dose
592886|NCT00537771|B1|Baseline|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
592887|NCT00537771|P2|Participant Flow|TAM Group|Tamoxifen : 20 mg once daily oral dose
592888|NCT00537771|P1|Participant Flow|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
592889|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
592890|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
592891|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
592892|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
592893|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
592894|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
592895|NCT00537771|E2|Reported Event|TAM Group|Tamoxifen : 20 mg once daily oral dose
592896|NCT00537771|E1|Reported Event|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
592897|NCT00537745|B1|Baseline|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
592898|NCT00537745|P1|Participant Flow|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
592899|NCT00537745|O1|Outcome|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
592900|NCT00537745|O1|Outcome|Participants|Intervention Group
592901|NCT00537745|E1|Reported Event|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
592902|NCT00537680|B4|Baseline|Total|Total of all reporting groups
592903|NCT00537680|B3|Baseline|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
592904|NCT00537680|B2|Baseline|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
592905|NCT00537680|B1|Baseline|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
592906|NCT00537680|P3|Participant Flow|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
592907|NCT00537680|P2|Participant Flow|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
592908|NCT00537680|P1|Participant Flow|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
592909|NCT00537680|O3|Outcome|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
592910|NCT00537680|O2|Outcome|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
592911|NCT00537680|O1|Outcome|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
592912|NCT00537680|E3|Reported Event|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
592913|NCT00537680|E2|Reported Event|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
592914|NCT00537680|E1|Reported Event|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
592915|NCT00537511|B1|Baseline|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
592916|NCT00537511|P1|Participant Flow|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
592917|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
592918|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592919|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Participants received daily oral pomalidomide 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592920|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Participants received daily oral pomalidomide 4 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592921|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Participants received daily oral pomalidomide 3 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592922|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Participants received daily oral pomalidomide 1 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592923|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
592924|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
592925|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592926|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592927|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592928|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592929|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592930|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592931|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592932|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592933|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592934|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
593281|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593282|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
592935|NCT00537511|E5|Reported Event|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
592936|NCT00537511|E4|Reported Event|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592937|NCT00537511|E3|Reported Event|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592938|NCT00537511|E2|Reported Event|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592939|NCT00537511|E1|Reported Event|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
592940|NCT00537485|B3|Baseline|Total|Total of all reporting groups
592941|NCT00537485|B2|Baseline|Placebo|transdermal application of placebo, 1 time per day
592942|NCT00537485|B1|Baseline|SPM962|transdermal application of SPM962, 1 time per day
592943|NCT00537485|P2|Participant Flow|Placebo|transdermal application of placebo, 1 time per day
592944|NCT00537485|P1|Participant Flow|SPM962|transdermal application of SPM962, 1 time per day
592945|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592946|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592947|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592948|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592949|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592950|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592951|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592952|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592953|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592954|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592955|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592956|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592957|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592958|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592959|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592960|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592961|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592962|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592963|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
592964|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
592965|NCT00537485|E2|Reported Event|Placebo|transdermal application of placebo, 1 time per day
592966|NCT00537485|E1|Reported Event|SPM962|transdermal application of SPM962, 1 time per day
592967|NCT00537407|B6|Baseline|Total|Total of all reporting groups
592968|NCT00537407|B5|Baseline|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592969|NCT00537407|B4|Baseline|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592970|NCT00537407|B3|Baseline|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592971|NCT00537407|B2|Baseline|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592972|NCT00537407|B1|Baseline|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593283|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
601178|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
592973|NCT00537407|P5|Participant Flow|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592974|NCT00537407|P4|Participant Flow|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592975|NCT00537407|P3|Participant Flow|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592976|NCT00537407|P2|Participant Flow|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592977|NCT00537407|P1|Participant Flow|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592978|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592979|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592980|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592981|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592982|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592983|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592984|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592985|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592986|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592987|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593284|NCT00536913|E2|Reported Event|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
601179|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
592988|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592989|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592990|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592991|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592992|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592993|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592994|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592995|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592996|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592997|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592998|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
592999|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593000|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593001|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593002|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593285|NCT00536913|E1|Reported Event|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
594352|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
593003|NCT00537407|O2|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593004|NCT00537407|O1|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593005|NCT00537407|O3|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593006|NCT00537407|O2|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593007|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593008|NCT00537407|E5|Reported Event|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593009|NCT00537407|E4|Reported Event|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593010|NCT00537407|E3|Reported Event|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593011|NCT00537407|E2|Reported Event|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593012|NCT00537407|E1|Reported Event|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
593013|NCT00537394|B4|Baseline|Total|Total of all reporting groups
593014|NCT00537394|B3|Baseline|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
593015|NCT00537394|B2|Baseline|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593016|NCT00537394|B1|Baseline|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593017|NCT00537394|P3|Participant Flow|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|[Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
593018|NCT00537394|P2|Participant Flow|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|[Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593333|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593019|NCT00537394|P1|Participant Flow|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|[Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593020|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593021|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593022|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593023|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593024|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593025|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593026|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593027|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593028|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593029|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593030|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593031|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593032|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593033|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593034|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593334|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593035|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593036|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593037|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593038|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593039|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593040|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593041|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593042|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593043|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593044|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593045|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593046|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593047|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593048|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593049|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593050|NCT00537394|E2|Reported Event|Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
593335|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593051|NCT00537394|E1|Reported Event|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
593052|NCT00537381|B3|Baseline|Total|Total of all reporting groups
593053|NCT00537381|B2|Baseline|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593054|NCT00537381|B1|Baseline|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593055|NCT00537381|P2|Participant Flow|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593056|NCT00537381|P1|Participant Flow|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593057|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593058|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593059|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593060|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593061|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593062|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593063|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593064|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593065|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593066|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593067|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593092|NCT00537316|B4|Baseline|Maintenance IFX/AZA (During Part 2)|Participants enrolled directly and randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
594353|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
593068|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593069|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593070|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593071|NCT00537381|E4|Reported Event|Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to Docetaxel (D) + Prednisone (P) + intetumumab (9 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily till disease progression.
593072|NCT00537381|E3|Reported Event|Docetaxel + Prednisone + Placebo/ Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to intetumumab alone (2 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks till disease progression.
593073|NCT00537381|E2|Reported Event|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
593074|NCT00537381|E1|Reported Event|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
593075|NCT00537329|B1|Baseline|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593076|NCT00537329|P1|Participant Flow|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593077|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593078|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593079|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593080|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593081|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593082|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593083|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593084|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593085|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593086|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593087|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593088|NCT00537329|E1|Reported Event|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
593089|NCT00537316|B7|Baseline|Total|Total of all reporting groups
593090|NCT00537316|B6|Baseline|Intermittent IFX (During Part 2)|Participants enrolled directly and randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA daily in Part 2 of the study (1 participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
593091|NCT00537316|B5|Baseline|Intermittent IFX/AZA (During Part 2)|Participants enrolled directly and randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
593212|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
593213|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
593093|NCT00537316|B3|Baseline|IFX/AZA|"All treated participants. IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
593094|NCT00537316|B2|Baseline|Azathioprine (AZA)|All treated participants. AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
593095|NCT00537316|B1|Baseline|Infliximab (IFX)|All treated participants. IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
593096|NCT00537316|P7|Participant Flow|Intermittent IFX (During Part 2)|Participants randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA as allocated in Part 1 of the study (1 participant from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
593097|NCT00537316|P6|Participant Flow|Intermittent IFX/AZA (During Part 2)|Participants randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
593098|NCT00537316|P5|Participant Flow|Maintenance IFX (During Part 2)|Participants randomized to maintenance IFX received infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) and placebo to AZA therapy as allocated in Part 1 of the study (all participants were from Part 1 of the study).
593099|NCT00537316|P4|Participant Flow|Maintenance IFX/AZA (During Part 2)|Participants randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
593100|NCT00537316|P3|Participant Flow|IFX/AZA|"IFX 5 mg/kg IV infusion at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more IFX infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
593101|NCT00537316|P2|Participant Flow|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one placebo IFX infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive IFX at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
593102|NCT00537316|P1|Participant Flow|Infliximab (IFX)|IFX 5 mg/kg Intravenous (IV) infusions administered at Weeks 0, 2, and 6 and placebo to AZA (orally) daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
593103|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
593104|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
593105|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
593106|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
593107|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
593108|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
593109|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
593110|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
593214|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
593215|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
593111|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
593112|NCT00537316|E14|Reported Event|IFX (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight until the end of the study. All participants were from Part 1 of the study.
593113|NCT00537316|E13|Reported Event|IFX/AZA (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight every 8 weeks and AZA 2.5 mg/kg of body weight orally daily until the end of the study. All participants were from Part 1 of the study.
593114|NCT00537316|E12|Reported Event|AZA (Part 2)|Participants received AZA 2.5 mg/kg of body weight orally daily for Part 2 of the study. All participants were from Part 1 of the study.
593115|NCT00537316|E11|Reported Event|Intermittent IFX (Part 2)|Participants randomized to intermittent IFX received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained). One participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
593116|NCT00537316|E10|Reported Event|Intermittent IFX/AZA (Part 2)|Participants randomized to intermittent IFX/AZA received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily. Three participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
593117|NCT00537316|E9|Reported Event|Maintenance IFX (Part 2)|Participants randomized to maintenance IFX received IV infusions of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry). All participants were from Part 1 of the study.
593118|NCT00537316|E8|Reported Event|Maintenance IFX/AZA (Part 2)|Participants randomized to maintenance IFX/AZA during Part 2 received IV infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily. Four participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
593119|NCT00537316|E7|Reported Event|IFX After Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
593120|NCT00537316|E6|Reported Event|IFX/AZA After Week 8|"Participants received IV infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
593121|NCT00537316|E5|Reported Event|AZA to IFX/AZA After Week 8|Participants received AZA 2.5 mg/kg orally for 16 weeks and had IV infusions of IFX 5mg/kg of body weight added to their treatment regimen at Weeks 8, 10, and 14. Participants were either non-responders to AZA at Week 8 or had worsening of disease at Week 8.
593122|NCT00537316|E4|Reported Event|AZA After Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
593123|NCT00537316|E3|Reported Event|IFX Through Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
593124|NCT00537316|E2|Reported Event|IFX/AZA Through Week 8|"Participants received intravenous (IV) infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
593125|NCT00537316|E1|Reported Event|AZA Through Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
593126|NCT00537303|B3|Baseline|Total|Total of all reporting groups
593127|NCT00537303|B2|Baseline|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593128|NCT00537303|B1|Baseline|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593129|NCT00537303|P2|Participant Flow|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593130|NCT00537303|P1|Participant Flow|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593131|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593216|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
593132|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593133|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593134|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593135|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593136|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593137|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593138|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593139|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593140|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593141|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593142|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593143|NCT00537303|E2|Reported Event|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593144|NCT00537303|E1|Reported Event|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
593145|NCT00537290|B1|Baseline|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
593146|NCT00537290|P1|Participant Flow|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
593147|NCT00537290|O1|Outcome|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
593148|NCT00537290|O1|Outcome|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
593149|NCT00537290|E1|Reported Event|Rituximab|"All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.~Rituximab: Rituximab 1000mg IV on Days 0 and 15"
593150|NCT00537277|B1|Baseline|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593217|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
593151|NCT00537277|P1|Participant Flow|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593152|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593153|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593154|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593155|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593156|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593157|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593158|NCT00537277|E1|Reported Event|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
593159|NCT00537238|B3|Baseline|Total|Total of all reporting groups
593160|NCT00537238|B2|Baseline|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593218|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
593219|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
593220|NCT00537082|E3|Reported Event|Placebo|Administered orally once daily for 6 months
593221|NCT00537082|E2|Reported Event|FTY720 0.5mg|Administered orally once daily for 6 months
593161|NCT00537238|B1|Baseline|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593162|NCT00537238|P2|Participant Flow|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593163|NCT00537238|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily (BID) for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the titration phase (TP). If seizure control was inadequate (adequate: at least [>=] 50% reduction in seizures), pregabalin dose was escalated to 225 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week maintenance phase(MP). Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during TP and MP. After MP, participants were allowed to progress into optional (opt) blinded continuation phase, and remained on dose from MP for a maximum of 2 years or until last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593164|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593165|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593166|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593167|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593168|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
601180|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
593169|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593170|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593171|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593172|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593173|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593174|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593175|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593176|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593222|NCT00537082|E1|Reported Event|FTY720 1.25mg|Administered orally once daily for 6 months
593177|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593178|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593179|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593180|NCT00537238|E2|Reported Event|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
593181|NCT00537238|E1|Reported Event|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
593182|NCT00537199|B1|Baseline|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
593183|NCT00537199|P1|Participant Flow|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
593184|NCT00537199|O1|Outcome|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
593185|NCT00537199|E1|Reported Event|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
593186|NCT00537095|B3|Baseline|Total|Total of all reporting groups
593187|NCT00537095|B2|Baseline|PLACEBO|PLACEBO
593188|NCT00537095|B1|Baseline|ZD6474|ZD6474, Vandetanib 300mg
593189|NCT00537095|P2|Participant Flow|PLACEBO|PLACEBO
593190|NCT00537095|P1|Participant Flow|ZD6474|ZD6474, Vandetanib 300mg
593191|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
593192|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
593193|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
593194|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
593195|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
593196|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
593197|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
593198|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
593199|NCT00537095|E2|Reported Event|PLACEBO|PLACEBO
593200|NCT00537095|E1|Reported Event|ZD6474|ZD6474, Vandetanib 300mg
593201|NCT00537082|B4|Baseline|Total|Total of all reporting groups
593202|NCT00537082|B3|Baseline|Placebo|Administered orally once daily for 6 months
593203|NCT00537082|B2|Baseline|FTY720 0.5 mg|Administered orally once daily for 6 months
593204|NCT00537082|B1|Baseline|FTY720 1.25 mg|Administered orally once daily for 6 months
593205|NCT00537082|P3|Participant Flow|Placebo|Administered orally once daily for 6 months
593206|NCT00537082|P2|Participant Flow|FTY720 0.5 mg|Administered orally once daily for 6 months
593207|NCT00537082|P1|Participant Flow|FTY720 1.25 mg|Administered orally once daily for 6 months
593208|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
593209|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
593210|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
593211|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
593223|NCT00537056|B1|Baseline|F-18 FDG PET/CT and DCE MRI|"FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po~FDG PET CT: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body~DCE MRI: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).~F-18 Fluoro-deoxi-glucose: 15 mCi iv~Gadolinium-DTPA: 0.1 mmol/kg iv~Sunitinib: 50 mg/day po"
593224|NCT00537056|P1|Participant Flow|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
593225|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
593226|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
593227|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
593228|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
593229|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
593230|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
593231|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan
593232|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
593233|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan
593234|NCT00537056|E1|Reported Event|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
593235|NCT00537030|B1|Baseline|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
593236|NCT00537030|P1|Participant Flow|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
593237|NCT00537030|O1|Outcome|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
593238|NCT00537030|E1|Reported Event|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
593239|NCT00537017|B1|Baseline|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593240|NCT00537017|P1|Participant Flow|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593241|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593242|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593243|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593244|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593245|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593246|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593247|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593248|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593249|NCT00537017|E1|Reported Event|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
593250|NCT00536991|B1|Baseline|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
593251|NCT00536991|P1|Participant Flow|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
593252|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
593253|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
593254|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
593255|NCT00536991|O1|Outcome|Treatment (Calcitriol, Ketoconazole, Hydrocortisone)|"PHASE I: Patients receive calcitriol PO QD on days 1-3, 8-10, 15-17, and 22-24. Patients also receive ketoconazole PO TID on days 1-24 and therapeutic hydrocortisone PO BID on days -1 to 24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive calcitriol and therapeutic hydrocortisone as in phase I. Patients also receive ketoconazole PO TID on days 4-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Calcitriol: Given PO~Ketoconazole: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Therapeutic Hydrocortisone: Given PO"
593256|NCT00536991|E1|Reported Event|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
593257|NCT00536978|B1|Baseline|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
593258|NCT00536978|P1|Participant Flow|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
593259|NCT00536978|O1|Outcome|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
593260|NCT00536978|E1|Reported Event|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
593261|NCT00536913|B3|Baseline|Total|Total of all reporting groups
593262|NCT00536913|B2|Baseline|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593263|NCT00536913|B1|Baseline|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593264|NCT00536913|P2|Participant Flow|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593265|NCT00536913|P1|Participant Flow|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593266|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593267|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593268|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593269|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593270|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593271|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593272|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593273|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593274|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593275|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593276|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593277|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593278|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
593279|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
593286|NCT00536874|B1|Baseline|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593287|NCT00536874|P1|Participant Flow|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593288|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593289|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593290|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593291|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593292|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593293|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593294|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593295|NCT00536874|E1|Reported Event|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
593296|NCT00536809|B1|Baseline|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle
593297|NCT00536809|P1|Participant Flow|Lapatinib/Oxaliplatin/Capecitabine|Phase I: Dose escalation to a maximum tolerated dose of lapatinib 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle. Phase II: Lapatinib 1000 mg/day administered orally on Days 1-21, oxaliplatin 130 mg/m^2 administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle.
593298|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593299|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593300|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593301|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
594354|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
593302|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593303|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593304|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593305|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593306|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593307|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593308|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593309|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593310|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593311|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593312|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593313|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593314|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593315|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593316|NCT00536809|E1|Reported Event|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
593317|NCT00536744|B3|Baseline|Total|Total of all reporting groups
593318|NCT00536744|B2|Baseline|Non-energized (Inactive) Application + Standard of Care|Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.
593319|NCT00536744|B1|Baseline|dermaPACE Application + Standard of Care|dermaPACE: dermaPACE + Standard of care wound dressing.
593320|NCT00536744|P2|Participant Flow|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
593321|NCT00536744|P1|Participant Flow|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
593322|NCT00536744|O2|Outcome|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
593323|NCT00536744|O1|Outcome|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
593324|NCT00536744|E2|Reported Event|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
593325|NCT00536744|E1|Reported Event|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
593326|NCT00536731|B4|Baseline|Total|Total of all reporting groups
593327|NCT00536731|B3|Baseline|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593328|NCT00536731|B2|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593329|NCT00536731|B1|Baseline|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593330|NCT00536731|P3|Participant Flow|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593331|NCT00536731|P2|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593332|NCT00536731|P1|Participant Flow|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593336|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593337|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593338|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593339|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593340|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593341|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593342|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593343|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593344|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593345|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593346|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593347|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593348|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593349|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593350|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593351|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593352|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593353|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593354|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593355|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593356|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593357|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593358|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593359|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593360|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593361|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593362|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593363|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593364|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593365|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593366|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593367|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593368|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593369|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
593370|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
593371|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
593372|NCT00536731|E3|Reported Event|Pulmicort Turbuhaler|Pulmicort Turbuhaler
593373|NCT00536731|E2|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler
593374|NCT00536731|E1|Reported Event|Symbicort pMDI|Symbicort pMDI
593375|NCT00536575|B1|Baseline|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
593376|NCT00536575|P1|Participant Flow|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
593377|NCT00536575|O1|Outcome|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
593378|NCT00536575|E1|Reported Event|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
593379|NCT00536510|B3|Baseline|Total|Total of all reporting groups
593699|NCT00536263|B3|Baseline|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up; treated participants.
593380|NCT00536510|B2|Baseline|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
593381|NCT00536510|B1|Baseline|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
593382|NCT00536510|P2|Participant Flow|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
593383|NCT00536510|P1|Participant Flow|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
593384|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
593385|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
593386|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
593387|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
593388|NCT00536510|E2|Reported Event|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
593389|NCT00536510|E1|Reported Event|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
593390|NCT00536484|B3|Baseline|Total|Total of all reporting groups
593391|NCT00536484|B2|Baseline|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593392|NCT00536484|B1|Baseline|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593393|NCT00536484|P2|Participant Flow|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593394|NCT00536484|P1|Participant Flow|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593395|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593396|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593397|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593398|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593399|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593400|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593401|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593402|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593700|NCT00536263|B2|Baseline|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
593403|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593404|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593405|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593406|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593407|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593408|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593409|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593410|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593411|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593412|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593413|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593414|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593415|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593416|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593417|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593418|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593419|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593420|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593421|NCT00536484|E2|Reported Event|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
593422|NCT00536484|E1|Reported Event|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
593423|NCT00536471|B5|Baseline|Total|Total of all reporting groups
593424|NCT00536471|B4|Baseline|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593425|NCT00536471|B3|Baseline|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593426|NCT00536471|B2|Baseline|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593427|NCT00536471|B1|Baseline|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
594355|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
593428|NCT00536471|P4|Participant Flow|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593429|NCT00536471|P3|Participant Flow|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593430|NCT00536471|P2|Participant Flow|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593431|NCT00536471|P1|Participant Flow|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593432|NCT00536471|O4|Outcome|Placebo (Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593433|NCT00536471|O3|Outcome|Placebo (Not Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593434|NCT00536471|O2|Outcome|Duloxetine (Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants were increased to duloxetine 120 mg QD, PO for 6 months
593435|NCT00536471|O1|Outcome|Duloxetine (Not Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants remained on duloxetine 60 mg QD, PO for 6 months.
593436|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593437|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593438|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593439|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593440|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593441|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593442|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593443|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593444|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593445|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593446|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593447|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593448|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593449|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593450|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593451|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593452|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593453|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593454|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593455|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593701|NCT00536263|B1|Baseline|PEG 1.0 mcg/kg QW * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
593456|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593457|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593458|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593459|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593460|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593461|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593462|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593463|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593464|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593465|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593466|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593467|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593468|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593469|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593470|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593471|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593472|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593473|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593474|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593475|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593476|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593477|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593478|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593479|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593480|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593481|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593482|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593483|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593541|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
593484|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593485|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593486|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593487|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593488|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593489|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593490|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593491|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593492|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593493|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593494|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593495|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593496|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593497|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593498|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593499|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593500|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593501|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593502|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593503|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593504|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593505|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593506|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593507|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593508|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593509|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593510|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593511|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593693|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
593512|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593513|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593514|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593515|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593516|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593517|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593518|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593519|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593520|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593521|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593522|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593523|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593524|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593525|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593526|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593527|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593528|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593529|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593530|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593531|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593532|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
593533|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
593534|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
593535|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
593536|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
593537|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
593538|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
593539|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
593540|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
593702|NCT00536263|P3|Participant Flow|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593542|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593543|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593544|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593545|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593546|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593547|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593548|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593549|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593550|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593551|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593552|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593553|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593554|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593555|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593556|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593557|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593558|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593559|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593560|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593561|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593562|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593563|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593564|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593565|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593566|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593567|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593568|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593569|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593694|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
593570|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593571|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593572|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593573|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593574|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593575|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593576|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593577|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593578|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593579|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593580|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593581|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593582|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593583|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593584|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593585|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593586|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593587|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593588|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593589|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593590|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593591|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593592|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593593|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593594|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593595|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593596|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593597|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593695|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
593598|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593599|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593600|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593601|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593602|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593603|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593604|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593605|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593606|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593607|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593608|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593609|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593610|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593611|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593612|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593613|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593614|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593615|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593616|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593617|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593618|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593619|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593620|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593621|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593622|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593623|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593624|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593625|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593696|NCT00536341|E2|Reported Event|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
593626|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593627|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593628|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593629|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593630|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593631|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593632|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593633|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593634|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593635|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593636|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593637|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593638|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593639|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593640|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593641|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593642|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593643|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593644|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593645|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593646|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593647|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593648|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593649|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593650|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593651|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593652|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593653|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593697|NCT00536341|E1|Reported Event|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
593654|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593655|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593656|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593657|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593658|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593659|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593660|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593661|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593662|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593663|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593664|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593665|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593666|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593667|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593668|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593669|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593670|NCT00536471|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
593671|NCT00536471|E1|Reported Event|Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
593672|NCT00536380|B4|Baseline|Total|Total of all reporting groups
593673|NCT00536380|B3|Baseline|20-mg Desloratadine|20-mg Desloratadine once daily
593674|NCT00536380|B2|Baseline|10-mg Desloratadine|10-mg Desloratadine once daily
593675|NCT00536380|B1|Baseline|5-mg Desloratadine|5-mg Desloratadine once daily
593676|NCT00536380|P3|Participant Flow|20-mg Desloratadine|20-mg Desloratadine once daily
593677|NCT00536380|P2|Participant Flow|10-mg Desloratadine|10-mg Desloratadine once daily
593678|NCT00536380|P1|Participant Flow|5-mg Desloratadine|5-mg Desloratadine once daily
593679|NCT00536380|O3|Outcome|10-mg Desloratadine|10-mg Desloratadine once daily
593680|NCT00536380|O2|Outcome|20-mg Desloratadine|20-mg Desloratadine once daily
593681|NCT00536380|O1|Outcome|5-mg Desloratadine|5-mg Desloratadine once daily
593682|NCT00536380|E3|Reported Event|20-mg Desloratadine|20-mg Desloratadine once daily
593683|NCT00536380|E2|Reported Event|10-mg Desloratadine|10-mg Desloratadine once daily
593684|NCT00536380|E1|Reported Event|5-mg Desloratadine|5-mg Desloratadine once daily
593685|NCT00536341|B3|Baseline|Total|Total of all reporting groups
593686|NCT00536341|B2|Baseline|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
593687|NCT00536341|B1|Baseline|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
593688|NCT00536341|P2|Participant Flow|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
593689|NCT00536341|P1|Participant Flow|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
593690|NCT00536341|O1|Outcome|All Patients|
593691|NCT00536341|O1|Outcome|All Patients|
593692|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
593703|NCT00536263|P2|Participant Flow|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593704|NCT00536263|P1|Participant Flow|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593705|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593706|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593707|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593708|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593709|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593710|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593711|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593712|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593713|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593714|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593715|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593716|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593717|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593718|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593719|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593720|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593721|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593722|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593723|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593724|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593725|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593726|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593727|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593728|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593729|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593730|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593731|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593732|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593733|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593734|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593735|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
593736|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
593737|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
593738|NCT00536263|E3|Reported Event|PEG 1.5 mcg/kg QW x48 Weeks|
593739|NCT00536263|E2|Reported Event|PEG 1.5 mcg/kg QW x24 Weeks|
593740|NCT00536263|E1|Reported Event|PEG 1.0 mcg/kg QW x24 Weeks|
593741|NCT00536198|B3|Baseline|Total|Total of all reporting groups
593742|NCT00536198|B2|Baseline|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593743|NCT00536198|B1|Baseline|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593744|NCT00536198|P2|Participant Flow|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593745|NCT00536198|P1|Participant Flow|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593746|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593831|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593832|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593747|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593748|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593749|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593750|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593751|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593752|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593753|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593754|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593755|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593756|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593757|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593758|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593759|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593760|NCT00536198|O2|Outcome|Placebo|Participants will take similarly looking placebo during the symptomatic period Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
593761|NCT00536198|O1|Outcome|Sertraline|Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
593762|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593786|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593763|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593764|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593765|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593766|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593767|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593768|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593769|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593770|NCT00536198|E2|Reported Event|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
593771|NCT00536198|E1|Reported Event|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
593772|NCT00536172|B3|Baseline|Total|Total of all reporting groups
593773|NCT00536172|B2|Baseline|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
593774|NCT00536172|B1|Baseline|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
593775|NCT00536172|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
593776|NCT00536172|P1|Participant Flow|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
593777|NCT00536172|O2|Outcome|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
593778|NCT00536172|O1|Outcome|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
593779|NCT00536172|E2|Reported Event|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
593780|NCT00536172|E1|Reported Event|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
593781|NCT00536120|B3|Baseline|Total|Total of all reporting groups
593782|NCT00536120|B2|Baseline|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
593783|NCT00536120|B1|Baseline|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593784|NCT00536120|P2|Participant Flow|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
593785|NCT00536120|P1|Participant Flow|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593830|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
602319|NCT00518011|B3|Baseline|Total|Total of all reporting groups
593787|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593788|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593789|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593790|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
593791|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593792|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
593793|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
593794|NCT00536120|E2|Reported Event|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at specified timepoints. They did not receive any treatment for their MS.
593795|NCT00536120|E1|Reported Event|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at specified timepoints following the 7th dose.
593796|NCT00536107|B3|Baseline|Total|Total of all reporting groups
593797|NCT00536107|B2|Baseline|Docetaxel|docetaxel 60mg/m sq
593798|NCT00536107|B1|Baseline|Gefitinib|gefitinib 250mg
593799|NCT00536107|P2|Participant Flow|Docetaxel|docetaxel 60mg/m sq
593800|NCT00536107|P1|Participant Flow|Gefitinib|gefitinib 250mg
593801|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
593802|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
593803|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
593804|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
593805|NCT00536107|E2|Reported Event|Docetaxel|docetaxel 60mg/m sq
593806|NCT00536107|E1|Reported Event|Gefitinib|gefitinib 250mg
593807|NCT00535938|B3|Baseline|Total|Total of all reporting groups
593808|NCT00535938|B2|Baseline|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593809|NCT00535938|B1|Baseline|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593810|NCT00535938|P2|Participant Flow|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593811|NCT00535938|P1|Participant Flow|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593812|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593813|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593814|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593815|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593816|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593817|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593818|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593819|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593820|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593821|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593822|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593823|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593824|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593825|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593826|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593827|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593828|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593829|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593833|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593834|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593835|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593836|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593837|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593838|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593839|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593840|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593841|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593842|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593843|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593844|NCT00535938|E2|Reported Event|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
593845|NCT00535938|E1|Reported Event|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
593846|NCT00535873|B1|Baseline|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
593847|NCT00535873|P1|Participant Flow|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
593848|NCT00535873|O1|Outcome|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
593849|NCT00535873|E1|Reported Event|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
593850|NCT00535847|B4|Baseline|Total|Total of all reporting groups
593851|NCT00535847|B3|Baseline|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593852|NCT00535847|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593853|NCT00535847|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593854|NCT00535847|P3|Participant Flow|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593855|NCT00535847|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593856|NCT00535847|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593857|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593858|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593859|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593860|NCT00535847|O4|Outcome|Did Not Achieve eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 [NCT00535847]).
593861|NCT00535847|O3|Outcome|Did Not Achieve eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who did not achieve eRVR but achieved SVR in this study (VX06-950-107 [NCT00535847]).
593931|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593862|NCT00535847|O2|Outcome|Achieved eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR but did not achieve SVR in this study (VX06-950-107 [NCT00535847]).
593863|NCT00535847|O1|Outcome|Achieved eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR and SVR in this study (VX06-950-107 [NCT00535847]).
593864|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593865|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593866|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593867|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593868|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593869|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593870|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593871|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593872|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593873|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593874|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593875|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593876|NCT00535847|E3|Reported Event|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
593877|NCT00535847|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
593932|NCT00535730|O1|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593933|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593878|NCT00535847|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
593879|NCT00535821|B3|Baseline|Total|Total of all reporting groups
593880|NCT00535821|B2|Baseline|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
593881|NCT00535821|B1|Baseline|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
593882|NCT00535821|P2|Participant Flow|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
593883|NCT00535821|P1|Participant Flow|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
593884|NCT00535821|O2|Outcome|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
593885|NCT00535821|O1|Outcome|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
593886|NCT00535821|E2|Reported Event|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
593887|NCT00535821|E1|Reported Event|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
593888|NCT00535782|B3|Baseline|Total|Total of all reporting groups
593889|NCT00535782|B2|Baseline|Placebo + MTX|During Part 1 of the study participants received placebo intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received 8 mg/kg TCZ IV every 4 weeks plus 7.5-25 mg MTX weekly.
593890|NCT00535782|B1|Baseline|TCZ + MTX|During Part 1 of the study participants received 8 mg/kg tocilizumab (TCZ) by intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received open-label 8 mg/kg TCZ every 4 weeks plus 7.5-25 mg MTX weekly.
593891|NCT00535782|P3|Participant Flow|Part 2: TCZ + MTX|During Part 2 of the study, from Week 24 to Week 104, all participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
593892|NCT00535782|P2|Participant Flow|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
593893|NCT00535782|P1|Participant Flow|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
593894|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
593895|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
593896|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
593897|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
593898|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
593899|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
593900|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
593901|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
593902|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
593903|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
593904|NCT00535782|E3|Reported Event|All TCZ + MTX|Includes patients who received at least one dose of active tocilizumab (TCZ) regardless of when they received it during the study and whether it was double-blind (Part 1) or open-label (Part 2). Participants received 8 mg/kg TCZ by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
593905|NCT00535782|E2|Reported Event|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
593906|NCT00535782|E1|Reported Event|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
593907|NCT00535769|B3|Baseline|Total|Total of all reporting groups
593908|NCT00535769|B2|Baseline|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593909|NCT00535769|B1|Baseline|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593910|NCT00535769|P2|Participant Flow|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593911|NCT00535769|P1|Participant Flow|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593912|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593913|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593914|NCT00535769|O1|Outcome|Usefulness of Text Messaging System|Patients with text reminder system were asked their opinion of the usefulness of message reminder from 0-10 (0, not useful at all; 10,most useful)
593915|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593916|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593917|NCT00535769|E2|Reported Event|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593918|NCT00535769|E1|Reported Event|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
593919|NCT00535730|B3|Baseline|Total|Total of all reporting groups
593920|NCT00535730|B2|Baseline|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593921|NCT00535730|B1|Baseline|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593922|NCT00535730|P2|Participant Flow|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593923|NCT00535730|P1|Participant Flow|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593924|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593925|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593926|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593927|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593928|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593929|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593930|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593934|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593935|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593936|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593937|NCT00535730|E2|Reported Event|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
593938|NCT00535730|E1|Reported Event|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
593939|NCT00535652|B1|Baseline|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
593940|NCT00535652|P1|Participant Flow|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
593941|NCT00535652|O1|Outcome|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
593942|NCT00535652|E1|Reported Event|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
593943|NCT00535626|B1|Baseline|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593944|NCT00535626|P1|Participant Flow|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593945|NCT00535626|O1|Outcome|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593946|NCT00535626|O1|Outcome|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593947|NCT00535626|O1|Outcome|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593948|NCT00535626|O1|Outcome|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593949|NCT00535626|O1|Outcome|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593950|NCT00535626|O1|Outcome|Trident® Tritanium™ Acetabular Shell|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
593951|NCT00535626|E2|Reported Event|Non-operative Site Events|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Non-Operative site events are reported by participant.
593952|NCT00535626|E1|Reported Event|Operative Site Events|Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Operative site events are reported by hip.
593953|NCT00535587|B5|Baseline|Total|Total of all reporting groups
593954|NCT00535587|B4|Baseline|Placebo Pill and Attention Control|
593955|NCT00535587|B3|Baseline|Placebo Pill and Exercise|
593956|NCT00535587|B2|Baseline|Mestinon and Attention Control|
593957|NCT00535587|B1|Baseline|Mestinon & Exercise|
593958|NCT00535587|P4|Participant Flow|Placebo Pill and Attention Control|
593959|NCT00535587|P3|Participant Flow|Placebo Pill and Exercise|
593960|NCT00535587|P2|Participant Flow|Mestinon and Attention Control|
593961|NCT00535587|P1|Participant Flow|Mestinon & Exercise|
593962|NCT00535587|O2|Outcome|Placebo Pill/Attention Control|
593963|NCT00535587|O1|Outcome|Mestinon/Exercise|
593964|NCT00535587|E4|Reported Event|Placebo Pill and Attention Control|
593965|NCT00535587|E3|Reported Event|Placebo Pill and Exercise|
593966|NCT00535587|E2|Reported Event|Mestinon and Attention Control|
593967|NCT00535587|E1|Reported Event|Mestinon & Exercise|
593968|NCT00535496|B3|Baseline|Total|Total of all reporting groups
593969|NCT00535496|B2|Baseline|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593970|NCT00535496|B1|Baseline|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593971|NCT00535496|P4|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
593972|NCT00535496|P3|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
593973|NCT00535496|P2|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
593974|NCT00535496|P1|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
594011|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
593975|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593976|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593977|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593978|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593979|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593980|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593981|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593982|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593983|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593984|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593985|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593986|NCT00535496|E2|Reported Event|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593987|NCT00535496|E1|Reported Event|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
593988|NCT00535405|B6|Baseline|Total|Total of all reporting groups
593989|NCT00535405|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
593990|NCT00535405|B4|Baseline|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
593991|NCT00535405|B3|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
593992|NCT00535405|B2|Baseline|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
593993|NCT00535405|B1|Baseline|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
593994|NCT00535405|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
593995|NCT00535405|P4|Participant Flow|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
593996|NCT00535405|P3|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
593997|NCT00535405|P2|Participant Flow|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
593998|NCT00535405|P1|Participant Flow|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
593999|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
594000|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
594001|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
594002|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
594003|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
594004|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
594005|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
594006|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
594007|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
594008|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
594009|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
594010|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
594012|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
594013|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
594014|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
594015|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
594016|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
594017|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
594018|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
594019|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
594020|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
594021|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
594022|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
594023|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
594024|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
594025|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
594026|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
594027|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
594028|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
594029|NCT00535405|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily for 12 weeks
594030|NCT00535405|E4|Reported Event|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
594031|NCT00535405|E3|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
594032|NCT00535405|E2|Reported Event|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
594033|NCT00535405|E1|Reported Event|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
594034|NCT00535392|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
594035|NCT00535392|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
594036|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
594037|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
594038|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
594039|NCT00535392|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
594040|NCT00535301|B3|Baseline|Total|Total of all reporting groups
594041|NCT00535301|B2|Baseline|Perigee|Anterior vaginal prolapse repair with graft
594042|NCT00535301|B1|Baseline|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
594043|NCT00535301|P2|Participant Flow|Perigee|Anterior vaginal prolapse repair with graft
594044|NCT00535301|P1|Participant Flow|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
594045|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
594046|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
594047|NCT00535301|O2|Outcome|Perigee (Grafted Repair)|Anterior vaginal prolapse repair with graft
594048|NCT00535301|O1|Outcome|Anterior Colporrhaphy (Sutured Repair)|Sutured anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
594049|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
594050|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
594051|NCT00535301|E2|Reported Event|Perigee|Anterior vaginal prolapse repair with graft
594052|NCT00535301|E1|Reported Event|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
594053|NCT00535288|B6|Baseline|Total|Total of all reporting groups
594054|NCT00535288|B5|Baseline|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
606330|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
594055|NCT00535288|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594056|NCT00535288|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594057|NCT00535288|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594058|NCT00535288|B1|Baseline|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594059|NCT00535288|P5|Participant Flow|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
594060|NCT00535288|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594061|NCT00535288|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594062|NCT00535288|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594063|NCT00535288|P1|Participant Flow|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
594064|NCT00535288|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
594065|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
594066|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594067|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594068|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594069|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
594070|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
594071|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594072|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594073|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
594074|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
594075|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594076|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594077|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594078|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594079|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
594080|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594081|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594082|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594083|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594084|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594085|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594086|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594087|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594088|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594089|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594090|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594091|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594092|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594093|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594094|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594095|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594096|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594097|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594098|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594099|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594100|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594101|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594102|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594103|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594104|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594105|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594106|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594107|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594108|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594109|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594110|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594111|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594112|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594113|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594114|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594115|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594116|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594117|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594118|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594119|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594120|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594121|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594122|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594123|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
594124|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594125|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594126|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594127|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594128|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
594129|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
594130|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594131|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594132|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594133|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
594134|NCT00535288|E5|Reported Event|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
594135|NCT00535288|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
594136|NCT00535288|E3|Reported Event|Esmertazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
594137|NCT00535288|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
594138|NCT00535288|E1|Reported Event|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
594139|NCT00535262|B1|Baseline|Open EmSam|8-week open-label treatment with EmSam
594140|NCT00535262|P1|Participant Flow|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
594141|NCT00535262|O1|Outcome|EmSam|"EmSam was administered in open-label fashion during phase I of the study during which symptoms of depression were assessed weekly. The study was terminated early so the data are not reported.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
594142|NCT00535262|E1|Reported Event|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
594143|NCT00535223|B3|Baseline|Total|Total of all reporting groups
594144|NCT00535223|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
594195|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594145|NCT00535223|B1|Baseline|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
594146|NCT00535223|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
594147|NCT00535223|P1|Participant Flow|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
594148|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
594149|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below~Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
594150|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
594151|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below~Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
594152|NCT00535223|E2|Reported Event|Present Centered Group Therapy|Present Centered Group Therapy. No serious adverse events occurred in response to this treatment.
594153|NCT00535223|E1|Reported Event|Group Based Exposure Therapy|Group Based Exposure Therapy. No serious adverse events occurred in response to this treatment.
594154|NCT00535145|B1|Baseline|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
594155|NCT00535145|P1|Participant Flow|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)
594156|NCT00535145|O2|Outcome|Paliperidone ER Phase|Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
594157|NCT00535145|O1|Outcome|TAU Phase|Day 1 through Day 27 (4 weeks)
594158|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
594159|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
594160|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
594161|NCT00535145|E3|Reported Event|TAU - All Enrolled Participants|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
594162|NCT00535145|E2|Reported Event|Paliperidone ER Phase|Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
594163|NCT00535145|E1|Reported Event|TAU - Pali ER|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks who went on to participate in Phase 2 (Paliperidone ER Phase).
594164|NCT00535132|B3|Baseline|Total|Total of all reporting groups
606574|NCT00507416|B4|Baseline|Total|Total of all reporting groups
594165|NCT00535132|B2|Baseline|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594166|NCT00535132|B1|Baseline|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594167|NCT00535132|P2|Participant Flow|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594168|NCT00535132|P1|Participant Flow|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594169|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594170|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594171|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594172|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594173|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594174|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594175|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594176|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594177|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594178|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594179|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594180|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594181|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594182|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594183|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594184|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594185|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594186|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594187|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594188|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594189|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594190|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594191|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594192|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594193|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594194|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594196|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594197|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594198|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594199|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594200|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594201|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594202|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594203|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594204|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594205|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594206|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594207|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594208|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594209|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594210|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594211|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594212|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594213|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594214|NCT00535132|E3|Reported Event|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
594215|NCT00535132|E2|Reported Event|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
594216|NCT00535132|E1|Reported Event|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
594217|NCT00535002|B9|Baseline|Total|Total of all reporting groups
594218|NCT00535002|B8|Baseline|Control Males, Placebo Then Yohimbine|non-dependent males, received placebo day and yohimbine day 2
594219|NCT00535002|B7|Baseline|Control Males, Yohimbine Then Placebo|non-dependent males, received yohimbine day and placebo day 2
594220|NCT00535002|B6|Baseline|Control Females, Placebo Then Yohimbine|non-dependent females, received placebo day and yohimbine day 2
594221|NCT00535002|B5|Baseline|Control Females, Yohimbine Then Placebo|non-dependent females, received yohimbine day and placebo day 2
594222|NCT00535002|B4|Baseline|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, received placebo day 1, yohimbine day 2
594223|NCT00535002|B3|Baseline|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, received yohimbine day 1, placebo day 2
594224|NCT00535002|B2|Baseline|Cocaine Females, Placebo Then Yohimbine|Cocaine-dependent females, received placebo day 1, yohimbine day 2
594225|NCT00535002|B1|Baseline|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, received yohimbine day 1, placebo day 2
594226|NCT00535002|P8|Participant Flow|Control Males, Placebo Then Yohimbine|Non-dependent males, placebo then yohimbine
594227|NCT00535002|P7|Participant Flow|Control Females, Placebo Then Yohimbine|Non-dependent females, placebo then yohimbine
594228|NCT00535002|P6|Participant Flow|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, Placebo then Yohimbine
594229|NCT00535002|P5|Participant Flow|Cocaine Females, Placebo Then Yohimbine|Cocaine females-dependent females, Placebo then yohimbine
594230|NCT00535002|P4|Participant Flow|Control Males, Yohimbine Then Placebo|Non-dependent males, Yohimbine then placebo
594231|NCT00535002|P3|Participant Flow|Control Females, Yohimbine Then Placebo|Non-dependent females, Yohimbine then placebo
594232|NCT00535002|P2|Participant Flow|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, Yohimbine then placebo
607107|NCT00505765|B4|Baseline|Total|Total of all reporting groups
594233|NCT00535002|P1|Participant Flow|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, Yohimbine then placebo
594234|NCT00535002|O8|Outcome|Control Males Placebo|
594235|NCT00535002|O7|Outcome|Control Males Yohimbine|
594236|NCT00535002|O6|Outcome|Control Females Placebo|
594237|NCT00535002|O5|Outcome|Control Females Yohimbine|
594238|NCT00535002|O4|Outcome|Cocaine Males Placebo|Cocaine-dependent males pre-treated with placebo
594239|NCT00535002|O3|Outcome|Cocaine Males Yohimbine|Cocaine-dependent males pre-treated with yohimbine
594240|NCT00535002|O2|Outcome|Cocaine Females Placebo|Cocaine-dependent females pre-treated with placebo
594241|NCT00535002|O1|Outcome|Cocaine Females Yohimbine|Cocaine-dependent females pre-treated with yohimbine
594242|NCT00535002|E4|Reported Event|Control Males|Non-dependent males
594243|NCT00535002|E3|Reported Event|Control Females|Non-dependent females
594244|NCT00535002|E2|Reported Event|Cocaine Males|Cocaine-dependent males
594245|NCT00535002|E1|Reported Event|Cocaine Females|Cocaine-dependent females
594246|NCT00534976|B3|Baseline|Total|Total of all reporting groups
594247|NCT00534976|B2|Baseline|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
594248|NCT00534976|B1|Baseline|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
594249|NCT00534976|P2|Participant Flow|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
594250|NCT00534976|P1|Participant Flow|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
594251|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594252|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594253|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594254|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594255|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594256|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594257|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594282|NCT00534937|E2|Reported Event|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
594258|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594259|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594260|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594261|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594262|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594263|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594264|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594265|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594266|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594267|NCT00534976|E2|Reported Event|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594268|NCT00534976|E1|Reported Event|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
594269|NCT00534937|B3|Baseline|Total|Total of all reporting groups
594270|NCT00534937|B2|Baseline|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
594271|NCT00534937|B1|Baseline|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
594272|NCT00534937|P2|Participant Flow|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
594273|NCT00534937|P1|Participant Flow|Standard Compression|Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).
594274|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
594275|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once-weekly short-stretch compression wrapping).
594276|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
594277|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
594278|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
594279|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
594280|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
594281|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
594283|NCT00534937|E1|Reported Event|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
594285|NCT00534833|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594286|NCT00534833|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594287|NCT00534833|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594288|NCT00534833|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594289|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594290|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594291|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594292|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594293|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
594294|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
594295|NCT00534833|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594296|NCT00534833|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
594297|NCT00534794|B3|Baseline|Total|Total of all reporting groups
594298|NCT00534794|B2|Baseline|Pataday|1 drop each eye for 1 day
594299|NCT00534794|B1|Baseline|Elestat|1 drop each eye for 2 days
594300|NCT00534794|P2|Participant Flow|Pataday|1 drop each eye for 1 day
594301|NCT00534794|P1|Participant Flow|Elestat|1 drop each eye for 2 days
594302|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
594303|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
594304|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
594305|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
594306|NCT00534794|E2|Reported Event|Pataday|1 drop each eye for 1 day
594307|NCT00534794|E1|Reported Event|Elestat|1 drop each eye for 2 days
594308|NCT00534638|B3|Baseline|Total|Total of all reporting groups
594309|NCT00534638|B2|Baseline|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594310|NCT00534638|B1|Baseline|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594311|NCT00534638|P2|Participant Flow|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594312|NCT00534638|P1|Participant Flow|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594313|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594314|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594315|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594316|NCT00534638|O1|Outcome|Cervarix Pooled Group|Female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594317|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594356|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594318|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594319|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594320|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594321|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594322|NCT00534638|O1|Outcome|Cervarix Pooled Group|male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594323|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594324|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594325|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594326|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594327|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594328|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594329|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594330|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594331|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594332|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594333|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594334|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594335|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594336|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594337|NCT00534638|O2|Outcome|Cervarix/Engerix-B Pooled Group|Male and female subjects receiving Cervarix™/Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594338|NCT00534638|O1|Outcome|No-vaccine Group|Subjects who were enrolled but not vaccinated.
594339|NCT00534638|O3|Outcome|Engerix-B Group|All adolescents were vaccinated with Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594340|NCT00534638|O2|Outcome|Cervarix/Engerix-B B Group|90% of the female adolescents received Cervarix™ vaccine. Male adolescents and rest of the female adolescents received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594341|NCT00534638|O1|Outcome|Cervarix/Engerix-B A Group|90% of male and female adolescents received Cervarix™ vaccine. Rest of the subjects received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594342|NCT00534638|E2|Reported Event|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594343|NCT00534638|E1|Reported Event|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
594344|NCT00534599|B3|Baseline|Total|Total of all reporting groups
594345|NCT00534599|B2|Baseline|Placebo|Matching placebo tablets once daily
594346|NCT00534599|B1|Baseline|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594347|NCT00534599|P2|Participant Flow|Placebo|Matching placebo tablets once daily
594348|NCT00534599|P1|Participant Flow|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594349|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594350|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594351|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594357|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594358|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594359|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594360|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594361|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594362|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594363|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594364|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594365|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594366|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594367|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594368|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594369|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594370|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594371|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594372|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594373|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594374|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594375|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594376|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594377|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
594378|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594379|NCT00534599|E2|Reported Event|Placebo|Matching placebo tablets once daily
594380|NCT00534599|E1|Reported Event|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
594381|NCT00534495|B3|Baseline|Total|Total of all reporting groups
594382|NCT00534495|B2|Baseline|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594383|NCT00534495|B1|Baseline|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594384|NCT00534495|P3|Participant Flow|Long Term Extension All Participants|All participants who benefited from rilonacept were eligible to enroll this phase and receive rilonacept 2.2mg/kg weekly
594385|NCT00534495|P2|Participant Flow|Placebo|"Placebo loading dose followed by maintenance dose for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the long term extension~Rilonacept: 2.2 mg/kg subcutaneously"
594386|NCT00534495|P1|Participant Flow|Rilonacept|Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week followed by a placebo loading dose and then rilonacept in the long term extension phase Rilonacept: 2.2 mg/kg subcutaneously
594387|NCT00534495|O3|Outcome|Long Term Extension 24 Weeks to 21 Months|
594388|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594389|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594390|NCT00534495|O3|Outcome|Week 24- All Subjects|
594391|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594392|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594393|NCT00534495|O3|Outcome|Week 24- All Subjects|
594394|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594395|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594396|NCT00534495|O3|Outcome|Week 24- All Subjects|
594397|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594398|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594399|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594400|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594401|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594402|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594403|NCT00534495|E5|Reported Event|Long Term Extension 24 Weeks to 21 Months|
594404|NCT00534495|E4|Reported Event|Placebo Week (4-24)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594405|NCT00534495|E3|Reported Event|Rilonacept Week (4-24)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594406|NCT00534495|E2|Reported Event|Placebo Week (0-4)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
607996|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
594407|NCT00534495|E1|Reported Event|Rilonacept Week (0-4)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
594408|NCT00534417|B1|Baseline|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594409|NCT00534417|P1|Participant Flow|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg orally (po) in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594410|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594411|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594412|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594413|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594414|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594415|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594416|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594417|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594418|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594419|NCT00534417|E1|Reported Event|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
594420|NCT00534404|B4|Baseline|Total|Total of all reporting groups
594421|NCT00534404|B3|Baseline|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594422|NCT00534404|B2|Baseline|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594423|NCT00534404|B1|Baseline|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594424|NCT00534404|P3|Participant Flow|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594441|NCT00534365|B1|Baseline|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594442|NCT00534365|P2|Participant Flow|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
594425|NCT00534404|P2|Participant Flow|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594426|NCT00534404|P1|Participant Flow|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594427|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594428|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594429|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594430|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594431|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594432|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594433|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594434|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594435|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594436|NCT00534404|E3|Reported Event|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594437|NCT00534404|E2|Reported Event|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594438|NCT00534404|E1|Reported Event|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
594439|NCT00534365|B3|Baseline|Total|Total of all reporting groups
594440|NCT00534365|B2|Baseline|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
595089|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
594443|NCT00534365|P1|Participant Flow|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594444|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594445|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
594446|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594447|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
594448|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594449|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
594450|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594451|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
594452|NCT00534365|O2|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
594453|NCT00534365|O1|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594454|NCT00534365|E2|Reported Event|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
594455|NCT00534365|E1|Reported Event|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
594456|NCT00534352|B1|Baseline|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
594457|NCT00534352|P1|Participant Flow|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
594458|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
594459|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
594460|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
594505|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
594592|NCT00534313|E4|Reported Event|Abatacept (Long-term Period)|Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
607997|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
594461|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
594462|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
594463|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
594464|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594465|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
594466|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
594467|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
594468|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594469|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
594470|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
594471|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
594472|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594473|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
594474|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
594475|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
594476|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594477|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
594478|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
594479|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
594480|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594481|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
594482|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
594483|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
594484|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594485|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
594486|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
594487|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
594488|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594489|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
594490|NCT00534352|O2|Outcome|Treatment B: TMC125 + TDF/FTC + DRV/Rtv|Treatment B: TMC125 + TDF/FTC + DRV/rtv.
594491|NCT00534352|O1|Outcome|Treatment A: TMC125 + TDF/FTC|Treatment A: TMC125 + TDF/FTC.
594492|NCT00534352|E4|Reported Event|Optional Extension|DRV/rtv + TDF/FTC
594493|NCT00534352|E3|Reported Event|Treatment C|DRV/rtv + TDF/FTC
594494|NCT00534352|E2|Reported Event|Treatment B|TMC125 + TDF/FTC + DRV/rtv
594495|NCT00534352|E1|Reported Event|Treatment A|TMC125 + TDF/FTC
594496|NCT00534313|B5|Baseline|Total|Total of all reporting groups
594497|NCT00534313|B4|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
594498|NCT00534313|B3|Baseline|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594499|NCT00534313|B2|Baseline|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
594500|NCT00534313|B1|Baseline|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
594501|NCT00534313|P4|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
594502|NCT00534313|P3|Participant Flow|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594503|NCT00534313|P2|Participant Flow|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
594504|NCT00534313|P1|Participant Flow|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
595090|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
594506|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594507|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000mg).
594508|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594509|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
594510|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594511|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594512|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg -calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594513|NCT00534313|O4|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
594514|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594515|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594516|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594517|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594518|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
594519|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594520|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594521|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594522|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594523|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
594524|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594525|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
594526|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg.
594527|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594528|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 169. All participants received a dose based on their screening visit weight as per by rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
594529|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594530|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
594531|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose based on their screening visit weight.
594532|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594533|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594534|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594535|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594536|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
594537|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
594538|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
594539|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594540|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594559|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594705|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
594541|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594542|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
594543|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594544|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594545|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594546|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
594547|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594548|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594549|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594550|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
594551|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594552|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594553|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594554|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
594555|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594556|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594557|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594558|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
594590|NCT00534313|O1|Outcome|All Treated Participants|Long-term period: All participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594560|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
594561|NCT00534313|O1|Outcome|Abatacept 30/10|Participants who received iv infusions of abatacept (30 mg/kg-calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594562|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
594563|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594564|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
594565|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
594566|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
594567|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594568|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg).
594569|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
594570|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594571|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594572|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594573|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594574|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594575|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594591|NCT00534313|E5|Reported Event|Placebo (Short-term Period)|Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
607998|NCT00502775|O1|Outcome|Placebo|
594576|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594577|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594578|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594579|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594580|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594581|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594582|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594583|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594584|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594585|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594586|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594587|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594588|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg). Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
594589|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
595091|NCT00532779|O3|Outcome|Placebo|Placebo
594593|NCT00534313|E3|Reported Event|Abatacept 30/10 (Short-term Period)|Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
594594|NCT00534313|E2|Reported Event|Abatacept 3/3 (Short-term Period)|Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
594595|NCT00534313|E1|Reported Event|Abatacept 10/10 (Short-term Period)|Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
594596|NCT00534248|B3|Baseline|Total|Total of all reporting groups
594597|NCT00534248|B2|Baseline|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
594598|NCT00534248|B1|Baseline|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
594599|NCT00534248|P2|Participant Flow|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
594600|NCT00534248|P1|Participant Flow|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
594601|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
594602|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
594603|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
594604|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
594605|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
594606|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
594607|NCT00534248|E2|Reported Event|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
594608|NCT00534248|E1|Reported Event|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
594609|NCT00534209|B1|Baseline|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
594610|NCT00534209|P1|Participant Flow|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
594611|NCT00534209|O2|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
594612|NCT00534209|O1|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
594613|NCT00534209|O2|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
594614|NCT00534209|O1|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
594615|NCT00534209|O2|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
594616|NCT00534209|O1|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
594617|NCT00534209|O2|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
594618|NCT00534209|O1|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
594619|NCT00534209|O2|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
594620|NCT00534209|O1|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
594621|NCT00534209|O2|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
594622|NCT00534209|O1|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
594623|NCT00534209|O2|Outcome|Arm II: Placebo|"Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Placebo: Given intradermally"
594667|NCT00534092|E1|Reported Event|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594624|NCT00534209|O1|Outcome|Arm I: Allogeneic B7.1/HLA-A1|"Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally.~Allogeneic B7.1/HLA-A1: Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally"
594625|NCT00534209|O1|Outcome|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
594626|NCT00534209|E1|Reported Event|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
594627|NCT00534105|B3|Baseline|Total|Total of all reporting groups
594628|NCT00534105|B2|Baseline|Normal Pregnancies|Normal pregnant women without gestational diabetes
594629|NCT00534105|B1|Baseline|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
594630|NCT00534105|P2|Participant Flow|Normal Pregnancies|Normal pregnant women without gestational diabetes
594631|NCT00534105|P1|Participant Flow|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
594632|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
594633|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
594634|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
594635|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
594636|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
594637|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
594638|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
594639|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
594640|NCT00534105|E2|Reported Event|Normal Pregnancies|Normal pregnant women without gestational diabetes
594641|NCT00534105|E1|Reported Event|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
594642|NCT00534092|B3|Baseline|Total|Total of all reporting groups
594643|NCT00534092|B2|Baseline|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594644|NCT00534092|B1|Baseline|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594645|NCT00534092|P2|Participant Flow|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594646|NCT00534092|P1|Participant Flow|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594647|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
594648|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594649|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594650|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
594651|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594652|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594653|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
594654|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594655|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594656|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
594657|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594658|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594659|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
594660|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594661|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594662|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
594663|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594664|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
594665|NCT00534092|E3|Reported Event|Total|Total patients included target group and safety group.
594666|NCT00534092|E2|Reported Event|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
594669|NCT00534001|B2|Baseline|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
594670|NCT00534001|B1|Baseline|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
594671|NCT00534001|P2|Participant Flow|4-week Run-in (Extended)|
594672|NCT00534001|P1|Participant Flow|1-week Run In (Standard)|
594673|NCT00534001|O2|Outcome|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
594674|NCT00534001|O1|Outcome|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
594675|NCT00534001|O2|Outcome|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
594676|NCT00534001|O1|Outcome|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
594677|NCT00534001|E2|Reported Event|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
594678|NCT00534001|E1|Reported Event|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
594679|NCT00533949|B5|Baseline|Total|Total of all reporting groups
594680|NCT00533949|B4|Baseline|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594681|NCT00533949|B3|Baseline|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594682|NCT00533949|B2|Baseline|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594683|NCT00533949|B1|Baseline|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594684|NCT00533949|P4|Participant Flow|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594685|NCT00533949|P3|Participant Flow|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594686|NCT00533949|P2|Participant Flow|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594687|NCT00533949|P1|Participant Flow|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594688|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
594689|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
594690|NCT00533949|O4|Outcome|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594691|NCT00533949|O3|Outcome|60 Gy RT + Cetuximab|60 gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594692|NCT00533949|O2|Outcome|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594693|NCT00533949|O1|Outcome|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594694|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
594695|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
594696|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
594697|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
594698|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
594699|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
594700|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
594701|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
594702|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
594703|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
594704|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
595092|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
594706|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
594707|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
594708|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
594709|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)
594710|NCT00533949|E4|Reported Event|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594711|NCT00533949|E3|Reported Event|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
594712|NCT00533949|E2|Reported Event|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594713|NCT00533949|E1|Reported Event|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
594714|NCT00533897|B4|Baseline|Total|Total of all reporting groups
594715|NCT00533897|B3|Baseline|Placebo Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to Placebo (Day 85-169).
594716|NCT00533897|B2|Baseline|Abatacept Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to ABA (Day 85-169).
594717|NCT00533897|B1|Baseline|Period 1 Non-Responders|Participants received abatacept (ABA) intravenous (IV) loading dose and subcutaneous (SC) injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 non-responders skipped Periods 2 and 3 and entered the long term extension (LTE).
594718|NCT00533897|P8|Participant Flow|Long Term Extension (LTE) Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594719|NCT00533897|P7|Participant Flow|Long Term Extension Abatacept for LI Period Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594720|NCT00533897|P6|Participant Flow|PLA Switched to ABA With PLA IV Loading Dose in RI Period|After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
594721|NCT00533897|P5|Participant Flow|PLA Switched to ABA With ABA IV Loading Dose in RI Period|After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
594722|NCT00533897|P4|Participant Flow|ABA With IV PLA Loading Dose in Re-introduction (RI) Period|After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
594723|NCT00533897|P3|Participant Flow|Placebo (PLA) Double Blind Withdrawal (DBW)|After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
594724|NCT00533897|P2|Participant Flow|Abatacept (ABA) Double-blind Withdrawal (DBW)|After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594725|NCT00533897|P1|Participant Flow|Abatacept (ABA) [Lead-In (LI)]|On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594726|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594727|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594778|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
607999|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
594728|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594729|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594730|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594731|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594732|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594733|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594734|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594735|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594736|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594737|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594738|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594751|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594739|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594740|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594741|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594742|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594743|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594744|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594745|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594746|NCT00533897|O1|Outcome|LTE Abatacept for All Participants|This group includes all participants who received at least one dose of 125 mg SC Abatacept during the LTE and includes both the LI Period 1 non-responder and the ST Completer cohorts.
594747|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594748|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594749|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594750|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594777|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594752|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594753|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
594754|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
594755|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594756|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594757|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594758|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594759|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594760|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594761|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594762|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594763|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594764|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594765|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594766|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594767|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594768|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594769|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594770|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594771|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594772|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594773|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594774|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594775|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594776|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594779|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594780|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594781|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594782|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594783|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594784|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594785|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594786|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594787|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594788|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594789|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594790|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594791|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594792|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594793|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594794|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594795|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594796|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594797|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594798|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594799|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594800|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594801|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594802|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594803|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594804|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594805|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594806|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594807|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594808|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594809|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594810|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594811|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594812|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594813|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594814|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594815|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594816|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594817|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594818|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
594819|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
594820|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594821|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594822|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594823|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594824|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594825|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594826|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594827|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594828|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594829|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594830|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594831|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594832|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594833|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594834|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594835|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594836|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594837|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594838|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594839|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594840|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594841|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594842|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594843|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594844|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594845|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594846|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594847|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594848|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594849|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594850|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
594851|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
594852|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594897|NCT00533507|P1|Participant Flow|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594853|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) Abatacept (ABA) dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
594854|NCT00533897|O2|Outcome|PLA Switched to ABA With PLA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
594855|NCT00533897|O1|Outcome|PLA Switched to ABA With ABA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
594856|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
594857|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
594858|NCT00533897|E4|Reported Event|Placebo Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Placebo SC injections starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were administered during Reintroduction Period 3 and during the LTE Period until completion of the LTE.
594859|NCT00533897|E3|Reported Event|Abatacept Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Abatacept SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were continued in Reintroduction Period 3 and during the LTE Period until completion of the LTE.
594860|NCT00533897|E2|Reported Event|Period 1 Non-Responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 until completion of the LTE.
594861|NCT00533897|E1|Reported Event|Period 1 Non-Completers|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. These participants did not complete the Period and did not continue in the study.
594862|NCT00533702|B3|Baseline|Total|Total of all reporting groups
594863|NCT00533702|B2|Baseline|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594864|NCT00533702|B1|Baseline|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594865|NCT00533702|P2|Participant Flow|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594866|NCT00533702|P1|Participant Flow|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594867|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594868|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594869|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594870|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594871|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594872|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594873|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594874|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594875|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
595093|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595094|NCT00532779|O3|Outcome|Placebo|Placebo
594876|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594877|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594878|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594879|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594880|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594881|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594882|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594883|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594884|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594885|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594886|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594887|NCT00533702|E2|Reported Event|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
594888|NCT00533702|E1|Reported Event|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
594889|NCT00533546|B1|Baseline|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
594890|NCT00533546|P1|Participant Flow|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
594891|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
594892|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
594893|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
594894|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
594895|NCT00533546|E1|Reported Event|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
594896|NCT00533507|B1|Baseline|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594898|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594899|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594900|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594901|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594902|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594903|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594904|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594905|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594906|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594907|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594908|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594909|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594910|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594911|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594912|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594913|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594914|NCT00533507|E1|Reported Event|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
594915|NCT00533442|B3|Baseline|Total|Total of all reporting groups
594916|NCT00533442|B2|Baseline|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
594917|NCT00533442|B1|Baseline|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
594918|NCT00533442|P2|Participant Flow|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
594919|NCT00533442|P1|Participant Flow|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
594920|NCT00533442|O2|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
594921|NCT00533442|O1|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
594922|NCT00533442|O2|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
594972|NCT00533273|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
594973|NCT00533117|B5|Baseline|Total|Total of all reporting groups
595013|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
594923|NCT00533442|O1|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
594924|NCT00533442|O2|Outcome|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
594925|NCT00533442|O1|Outcome|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
594926|NCT00533442|E2|Reported Event|Tacrolimus Plus Rapamycin Plus Steroids|"Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day."
594927|NCT00533442|E1|Reported Event|Tacrolimus Plus MMF Plus Steroids|"This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day"
594928|NCT00533351|B3|Baseline|Total|Total of all reporting groups
594929|NCT00533351|B2|Baseline|Placebo Followed by AGN201781|
594930|NCT00533351|B1|Baseline|AGN201781 Followed by Placebo|
594931|NCT00533351|P2|Participant Flow|Placebo Followed by AGN201781|
594932|NCT00533351|P1|Participant Flow|AGN201781 Followed by Placebo|
594933|NCT00533351|O2|Outcome|Placebo|
594934|NCT00533351|O1|Outcome|AGN201781|
594935|NCT00533351|O2|Outcome|Placebo|
594936|NCT00533351|O1|Outcome|AGN201781|
594937|NCT00533351|E2|Reported Event|Placebo Followed by AGN201781|
594938|NCT00533351|E1|Reported Event|AGN201781 Followed by Placebo|
594939|NCT00533273|B3|Baseline|Total|Total of all reporting groups
594940|NCT00533273|B2|Baseline|Placebo|Placebo (Sucrose and Tris) injection
594941|NCT00533273|B1|Baseline|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594942|NCT00533273|P2|Participant Flow|Placebo|Placebo (Sucrose and Tris) injection
594943|NCT00533273|P1|Participant Flow|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
594944|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594945|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594946|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594947|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594948|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594949|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594950|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594951|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594952|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594953|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594954|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594955|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594956|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594957|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594958|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594959|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594960|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594961|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594962|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594963|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594964|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594965|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594966|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594967|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594968|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594969|NCT00533273|O2|Outcome|Placebo|Placebo (Sucrose and Tris) injection
594970|NCT00533273|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
594971|NCT00533273|E2|Reported Event|Placebo|Placebo injection is comprised of sucrose and Tris
594974|NCT00533117|B4|Baseline|Supportive Therapy Placebo|"Supportive psychotherapy and placebo See above for descriptions.~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
594975|NCT00533117|B3|Baseline|Supportive Therapy Fluoxetine|"Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
594976|NCT00533117|B2|Baseline|Dialectical Behavior Therapy Placebo|"Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
594977|NCT00533117|B1|Baseline|Dialectical Behavior Therapy Fluoxetine|"Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
594978|NCT00533117|P4|Participant Flow|Supportive Therapy Placebo|"Supportive psychotherapy and placebo See above for descriptions.~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
594979|NCT00533117|P3|Participant Flow|Supportive Therapy Fluoxetine|"Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress."
594980|NCT00533117|P2|Participant Flow|DBT Placebo|"Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
594981|NCT00533117|P1|Participant Flow|DBT Fluoxetine|"Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.~Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated~Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group."
594982|NCT00533117|O2|Outcome|Supportive Therapy With or Without Fluoxetine|Participants received 12 months of ST and either Fluoxetine or placebo medication with weekly medication visits (double blind)
594983|NCT00533117|O1|Outcome|Dialectical Behavior Therapy With or Without Fluoxetine|Participants received 12 months of DBT and either Fluoxetine or placebo medication with weekly medication visits (double blind)
594984|NCT00533117|E4|Reported Event|Supportive Therapy With Placebo|Participants received 12 months of supportive therapy with placebo weekly medication management sessions(double blind). This condition served as the control condition. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
594985|NCT00533117|E3|Reported Event|Dialectical Behavior Therapy With Placebo|Participants received 12 months of DBT therapy with placebo medication with weekly medication management sessions (double blind). Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
594986|NCT00533117|E2|Reported Event|Supportive Therapy With Fluoxetine|Participants received 12 months of supportive therapy with fluoxetine weekly medication management sessions(double blind). Planned analyses were with supportive therapy/placebo. Also, fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
594987|NCT00533117|E1|Reported Event|Dialectical Behavior Therapy With Fluoxetine|Participants received 12 months of DBT therapy with fluoxetine with weekly medication management sessions (double blind). Primary planned analyses were with supportive therapy/placebo. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo.
594988|NCT00532948|B4|Baseline|Total|Total of all reporting groups
594989|NCT00532948|B3|Baseline|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
594990|NCT00532948|B2|Baseline|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
594991|NCT00532948|B1|Baseline|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
594992|NCT00532948|P3|Participant Flow|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
594993|NCT00532948|P2|Participant Flow|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
594994|NCT00532948|P1|Participant Flow|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
594995|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
594996|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
594997|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
594998|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
594999|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595000|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595001|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595002|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595003|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595004|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595005|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595006|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595007|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595008|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595009|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595010|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595011|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595012|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595084|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595085|NCT00532779|O3|Outcome|Placebo|Placebo
595014|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595015|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595016|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595017|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595018|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595019|NCT00532948|O1|Outcome|Capecitabine (Overall)|Capecitabine 500, 650, and 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595020|NCT00532948|E3|Reported Event|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595021|NCT00532948|E2|Reported Event|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595022|NCT00532948|E1|Reported Event|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
595023|NCT00532935|B3|Baseline|Total|Total of all reporting groups
595024|NCT00532935|B2|Baseline|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595025|NCT00532935|B1|Baseline|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595026|NCT00532935|P2|Participant Flow|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595027|NCT00532935|P1|Participant Flow|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595028|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595029|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595030|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595031|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595032|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595033|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595086|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595087|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595034|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595035|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595036|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595037|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595038|NCT00532935|E2|Reported Event|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595039|NCT00532935|E1|Reported Event|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
595040|NCT00532883|B5|Baseline|Total|Total of all reporting groups
595041|NCT00532883|B4|Baseline|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
595042|NCT00532883|B3|Baseline|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
595043|NCT00532883|B2|Baseline|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
595044|NCT00532883|B1|Baseline|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
595045|NCT00532883|P4|Participant Flow|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
595046|NCT00532883|P3|Participant Flow|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
595047|NCT00532883|P2|Participant Flow|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
595048|NCT00532883|P1|Participant Flow|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
595049|NCT00532883|O4|Outcome|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
595050|NCT00532883|O3|Outcome|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
595051|NCT00532883|O2|Outcome|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
595052|NCT00532883|O1|Outcome|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
595053|NCT00532883|E4|Reported Event|Placebo/Placebo|
595054|NCT00532883|E3|Reported Event|Placebo/Magnesium Pidolate|20 mg/kg/day HU + 0.6 mEq/kg/day Mg
595055|NCT00532883|E2|Reported Event|Hydroxyurea/Placebo|0.6 mEq/kg/day
595056|NCT00532883|E1|Reported Event|Hydroxyurea/Magnesium Pidolate|20 mg/kg/day
595057|NCT00532779|B4|Baseline|Total|Total of all reporting groups
595058|NCT00532779|B3|Baseline|Placebo|Placebo
595059|NCT00532779|B2|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595060|NCT00532779|B1|Baseline|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595061|NCT00532779|P3|Participant Flow|Placebo|Placebo
595062|NCT00532779|P2|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595063|NCT00532779|P1|Participant Flow|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595064|NCT00532779|O3|Outcome|Placebo|Placebo
595065|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595066|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595067|NCT00532779|O3|Outcome|Placebo|Placebo
595068|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595069|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595070|NCT00532779|O3|Outcome|Placebo|Placebo
595071|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595072|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595073|NCT00532779|O3|Outcome|Placebo|Placebo
595074|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595075|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595076|NCT00532779|O3|Outcome|Placebo|Placebo
595077|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595078|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595079|NCT00532779|O3|Outcome|Placebo|Placebo
595080|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595081|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595082|NCT00532779|O3|Outcome|Placebo|Placebo
595083|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595095|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595096|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595097|NCT00532779|O3|Outcome|Placebo|Placebo
595098|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595099|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595100|NCT00532779|O3|Outcome|Placebo|Placebo
595101|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595102|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595103|NCT00532779|O3|Outcome|Placebo|Placebo
595104|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595105|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595106|NCT00532779|O3|Outcome|Placebo|Placebo
595107|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595108|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595109|NCT00532779|O3|Outcome|Placebo|Placebo
595110|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595111|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595112|NCT00532779|O3|Outcome|Placebo|Placebo
595113|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595114|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595115|NCT00532779|O3|Outcome|Placebo|Placebo
595116|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595117|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595118|NCT00532779|E3|Reported Event|Placebo|Placebo
595119|NCT00532779|E2|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
595120|NCT00532779|E1|Reported Event|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
595121|NCT00532493|B3|Baseline|Total|Total of all reporting groups
595122|NCT00532493|B2|Baseline|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595123|NCT00532493|B1|Baseline|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595124|NCT00532493|P2|Participant Flow|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595125|NCT00532493|P1|Participant Flow|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595126|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595127|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595128|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595129|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595130|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595131|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595132|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595177|NCT00532298|P4|Participant Flow|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595912|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595133|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595134|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595135|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595136|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595137|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595138|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595139|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595140|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595141|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595142|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595143|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595144|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595145|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595146|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595147|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595148|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595178|NCT00532298|P3|Participant Flow|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
596133|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
595149|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595150|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595151|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595152|NCT00532493|E2|Reported Event|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
595153|NCT00532493|E1|Reported Event|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
595154|NCT00532480|B1|Baseline|Duloxetine|Duloxetine : 60 mg capsules
595155|NCT00532480|P1|Participant Flow|Duloxetine|Duloxetine 60 mg capsules orally daily open label
595156|NCT00532480|O1|Outcome|Duloxetine|Duloxetine : 60 mg capsules
595157|NCT00532480|E1|Reported Event|Duloxetine|Duloxetine : 60 mg capsules
595158|NCT00532441|B1|Baseline|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
595159|NCT00532441|P2|Participant Flow|Biliary|erlotinib and docetaxel
595160|NCT00532441|P1|Participant Flow|Hepatocellular|erlotinib and docetaxel
595161|NCT00532441|O2|Outcome|Biliary|erlotinib and docetaxel
595162|NCT00532441|O1|Outcome|Hepatocellular|erlotinib and docetaxel
595163|NCT00532441|O2|Outcome|Erlotinib and Docetaxel: Hepatocellular|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
595164|NCT00532441|O1|Outcome|Erlotinib and Docetaxel: Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
595165|NCT00532441|O2|Outcome|Hepatocellular|Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
595166|NCT00532441|O1|Outcome|Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
595167|NCT00532441|E1|Reported Event|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
595168|NCT00532298|B7|Baseline|Total|Total of all reporting groups
595169|NCT00532298|B6|Baseline|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595170|NCT00532298|B5|Baseline|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595171|NCT00532298|B4|Baseline|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595172|NCT00532298|B3|Baseline|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595173|NCT00532298|B2|Baseline|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595174|NCT00532298|B1|Baseline|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595175|NCT00532298|P6|Participant Flow|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595176|NCT00532298|P5|Participant Flow|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595968|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595179|NCT00532298|P2|Participant Flow|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595180|NCT00532298|P1|Participant Flow|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595181|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595182|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595183|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595184|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595185|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595186|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595187|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595188|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595189|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595190|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595191|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595192|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595193|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595194|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595195|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595196|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595197|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595198|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595199|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595200|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595201|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595202|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595203|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595204|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595205|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595206|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595207|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595208|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595484|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595209|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595210|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595211|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595212|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595213|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595214|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595215|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595216|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595217|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595218|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595219|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595220|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595221|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595222|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595223|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595224|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595225|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595226|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595227|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595228|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595229|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595230|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595231|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595232|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595233|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595234|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595235|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595236|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595237|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595238|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595239|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595240|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595241|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595242|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595243|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595244|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595245|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595246|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595247|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595248|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595249|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595250|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595251|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595252|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595253|NCT00532298|E6|Reported Event|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
595254|NCT00532298|E5|Reported Event|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
595255|NCT00532298|E4|Reported Event|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
595256|NCT00532298|E3|Reported Event|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
595257|NCT00532298|E2|Reported Event|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
595258|NCT00532298|E1|Reported Event|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
595259|NCT00532259|B1|Baseline|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
595260|NCT00532259|P1|Participant Flow|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
595261|NCT00532259|O1|Outcome|CT-011|CT-011: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
595262|NCT00532259|O1|Outcome|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
595263|NCT00532259|E1|Reported Event|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
595264|NCT00532155|B3|Baseline|Total|Total of all reporting groups
595265|NCT00532155|B2|Baseline|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
595266|NCT00532155|B1|Baseline|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595267|NCT00532155|P2|Participant Flow|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595268|NCT00532155|P1|Participant Flow|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595269|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
608000|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
595270|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595271|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595272|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595273|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595274|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595275|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595276|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595277|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595278|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595279|NCT00532155|E2|Reported Event|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
595280|NCT00532155|E1|Reported Event|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
595281|NCT00532129|B1|Baseline|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595282|NCT00532129|P1|Participant Flow|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles (28 day cycles). Participants who did not achieve complete response (CR) after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 milligrams per square meter per day (mg/m^2/day) oral administration (PO) on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595283|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595284|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595285|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595286|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595287|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595288|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595485|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595289|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595290|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595291|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595292|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595293|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595294|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595295|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595296|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595297|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595298|NCT00532129|E1|Reported Event|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
595299|NCT00531960|B3|Baseline|Total|Total of all reporting groups
595300|NCT00531960|B2|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
595301|NCT00531960|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595302|NCT00531960|P2|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
595317|NCT00531960|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595303|NCT00531960|P1|Participant Flow|Bevacizumab Plus (+) Chemotherapy|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 milligrams per square meter [mg/m^2], IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 milligrams per milliliter multiplied by minute [mg/mL*min] on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595304|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
595305|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595306|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
595307|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595308|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
595309|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595310|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
595311|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595312|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
595313|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595314|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
595315|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
595316|NCT00531960|E2|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
608001|NCT00502775|O1|Outcome|Placebo|
595319|NCT00531947|B2|Baseline|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595320|NCT00531947|B1|Baseline|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595321|NCT00531947|P2|Participant Flow|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595322|NCT00531947|P1|Participant Flow|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595323|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595324|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595325|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595326|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595327|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595328|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595329|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595330|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595331|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595332|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595333|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595334|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595335|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595336|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595337|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595338|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595339|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595340|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595341|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595342|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595343|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595344|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595345|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595346|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595347|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595348|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595349|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595350|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595351|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595352|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595353|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595354|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595355|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595356|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595357|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595358|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595359|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595360|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595361|NCT00531947|E2|Reported Event|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595362|NCT00531947|E1|Reported Event|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
595363|NCT00531934|B3|Baseline|Total|Total of all reporting groups
595364|NCT00531934|B2|Baseline|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595365|NCT00531934|B1|Baseline|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595366|NCT00531934|P2|Participant Flow|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595367|NCT00531934|P1|Participant Flow|Erlotinib Plus (+) Doxycycline|Participants received erlotinib 150 milligrams per day (mg/day), tablets, orally (PO) until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595368|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595369|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595370|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595371|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595372|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595373|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595374|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595375|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595376|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595377|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595378|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595379|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595380|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595381|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595382|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595383|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595384|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595385|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595386|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595387|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595388|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595389|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595390|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595391|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595392|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595393|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595394|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595395|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595396|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595397|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595398|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595399|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595400|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595401|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595402|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595403|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595404|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595405|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595406|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595407|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595408|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595409|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595410|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595411|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595412|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595486|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595413|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595414|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595415|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595416|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595417|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595418|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595419|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595420|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595421|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595422|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595423|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595424|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595425|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595426|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595427|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595428|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595429|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595430|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595431|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595432|NCT00531934|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
595433|NCT00531934|E1|Reported Event|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
595434|NCT00531882|B4|Baseline|Total|Total of all reporting groups
595435|NCT00531882|B3|Baseline|3-Ibuprofen 1000-1600 mg Twice Daily|Ibuprofen 1000-1600 mg twice daily (max 3200 mg/day)
595436|NCT00531882|B2|Baseline|2-Simvastin|"Simvastatin~Simvastatin: 40 mg once a day"
595437|NCT00531882|B1|Baseline|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day"
595438|NCT00531882|P3|Participant Flow|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|Ibuprofen will be used as the positive control for this study. Ibuprofen (Motrin, Pharmacia) will be administered twice daily.
595439|NCT00531882|P2|Participant Flow|2-Simvastatin|Simvastatin (Zocor): 40 mg once a day will be administered orally in a dose of 49 mg once daily to all subjects. This dose is considered a mid-level adult dose and the maximum pediatric dose recommended for hyperlipidemia.
595440|NCT00531882|P1|Participant Flow|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day pioglitazone (Actos, Takeda) will be administered orally in a dose of 30 mg once daily. This is the highest recommended dose for initial control of type II diabetes."
595441|NCT00531882|O3|Outcome|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|"Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day~Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day"
595442|NCT00531882|O2|Outcome|2-Simvastatin|"Simvastatin~Simvastatin: 40 mg once a day"
595443|NCT00531882|O1|Outcome|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day"
595444|NCT00531882|E3|Reported Event|3-Ibuprofen 1000-1600 mg Twice Daily (Max 3200 mg/Day)|"Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day~Ibuprofen: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day"
595445|NCT00531882|E2|Reported Event|2-Simvastin|"Simvastatin~Simvastatin: 40 mg once a day"
595446|NCT00531882|E1|Reported Event|1-Pioglitazone|"Pioglitazone~Pioglitazone: 30 mg once a day"
595447|NCT00531843|B3|Baseline|Total|Total of all reporting groups
596134|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
595448|NCT00531843|B2|Baseline|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
595449|NCT00531843|B1|Baseline|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
595450|NCT00531843|P2|Participant Flow|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary inferior vena cava (IVC) filter (prn as determined by caregiver).
595451|NCT00531843|P1|Participant Flow|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg via subcutaneous administration (SubQ) daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
595452|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
595453|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
595454|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
595455|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
595456|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
595457|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
595458|NCT00531843|E2|Reported Event|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
595459|NCT00531843|E1|Reported Event|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
595460|NCT00531817|B3|Baseline|Total|Total of all reporting groups
595461|NCT00531817|B2|Baseline|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595462|NCT00531817|B1|Baseline|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595463|NCT00531817|P2|Participant Flow|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595464|NCT00531817|P1|Participant Flow|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595465|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595466|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595467|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595468|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595469|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595470|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595471|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595472|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595473|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595474|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595475|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595476|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595477|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595478|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595479|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595480|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595481|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595482|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595483|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
595487|NCT00531817|E3|Reported Event|Placebo + DMARDs|Initially treated with placebo + DMARDs and received ≥ 1 dose of placebo. The placebo + DMARDs group includes all data collected while patients were on placebo for those who were initially treated with placebo in the double-blind treatment period.
595488|NCT00531817|E2|Reported Event|Placebo/Tocilizumab + DMARDs|Initially treated with placebo + DMARDs then received ≥ 1 dose of tocilizumab. The placebo/tocilizumab + DMARDs group includes all data collected after patients’ first infusion of tocilizumab (whether escape therapy or extended treatment) for those who were initially treated with placebo in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
595489|NCT00531817|E1|Reported Event|Tocilizumab + DMARDs|Initially treated with tocilizumab + DMARDs and received ≥ 1 dose of tocilizumab. The tocilizumab + DMARDs group includes all data (double-blind and extended treatment periods) for patients who were initially treated with tocilizumab in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
595490|NCT00531752|B5|Baseline|Total|Total of all reporting groups
595491|NCT00531752|B4|Baseline|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595492|NCT00531752|B3|Baseline|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595493|NCT00531752|B2|Baseline|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595494|NCT00531752|B1|Baseline|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595495|NCT00531752|P4|Participant Flow|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595496|NCT00531752|P3|Participant Flow|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595497|NCT00531752|P2|Participant Flow|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595498|NCT00531752|P1|Participant Flow|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
595499|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595500|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595501|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595502|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595503|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595504|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595505|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595506|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595507|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595508|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595969|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595509|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595510|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595511|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595512|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595513|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595514|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595515|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595516|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595517|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595518|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595519|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595520|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595521|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595522|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595523|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595524|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595525|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595526|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595527|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595528|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595529|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595530|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595531|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595532|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595533|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595534|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595535|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595536|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595537|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595538|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595539|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595540|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595541|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
608002|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
595542|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595543|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595544|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595545|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595546|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595547|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595548|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595549|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595550|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595551|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595552|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595553|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595554|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595555|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595556|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595557|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595558|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595559|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595560|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595561|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595562|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595563|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595564|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595565|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595566|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595567|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595568|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595569|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595570|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595571|NCT00531752|E3|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
595572|NCT00531752|E2|Reported Event|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
595573|NCT00531752|E1|Reported Event|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
595574|NCT00531661|B3|Baseline|Total|Total of all reporting groups
595575|NCT00531661|B2|Baseline|Control|CONTROL group: standard of care HF management
595576|NCT00531661|B1|Baseline|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595577|NCT00531661|P2|Participant Flow|Control|CONTROL group: standard of care HF management
595578|NCT00531661|P1|Participant Flow|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595579|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
595580|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
595581|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
595582|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595583|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
595584|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595585|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
595586|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595587|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
595588|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595589|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
595590|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595591|NCT00531661|O1|Outcome|Entire Randomized Study Cohort|
595592|NCT00531661|O1|Outcome|Entire Study Cohort|
595593|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
595594|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595595|NCT00531661|E2|Reported Event|Control|CONTROL group: standard of care HF management
595596|NCT00531661|E1|Reported Event|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
595597|NCT00531518|B3|Baseline|Total|Total of all reporting groups
595598|NCT00531518|B2|Baseline|Experimental Intervention|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
595599|NCT00531518|B1|Baseline|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
595600|NCT00531518|P2|Participant Flow|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
595601|NCT00531518|P1|Participant Flow|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
595602|NCT00531518|O2|Outcome|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
595603|NCT00531518|O1|Outcome|Control|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
595604|NCT00531518|E2|Reported Event|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
595913|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595605|NCT00531518|E1|Reported Event|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
595606|NCT00531479|B3|Baseline|Total|Total of all reporting groups
595607|NCT00531479|B2|Baseline|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595608|NCT00531479|B1|Baseline|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595609|NCT00531479|P2|Participant Flow|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595610|NCT00531479|P1|Participant Flow|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595611|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595612|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595613|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595614|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595615|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595616|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595617|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595618|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595619|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595653|NCT00531284|B17|Baseline|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
608003|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
595620|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595621|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595622|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595623|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595624|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595625|NCT00531479|E2|Reported Event|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595626|NCT00531479|E1|Reported Event|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
595627|NCT00531453|B3|Baseline|Total|Total of all reporting groups
595628|NCT00531453|B2|Baseline|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
595629|NCT00531453|B1|Baseline|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
595630|NCT00531453|P2|Participant Flow|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
595631|NCT00531453|P1|Participant Flow|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
595632|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
595633|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
595634|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
595635|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
595636|NCT00531453|E2|Reported Event|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
595637|NCT00531453|E1|Reported Event|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
595638|NCT00531427|B3|Baseline|Total|Total of all reporting groups
595639|NCT00531427|B2|Baseline|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
595640|NCT00531427|B1|Baseline|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
595641|NCT00531427|P2|Participant Flow|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
595642|NCT00531427|P1|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
595643|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
595644|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
595645|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
595646|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
595647|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
595648|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
595649|NCT00531427|E3|Reported Event|Open-label Run-in Period|The open-label run-in period was designed with duration of time sufficient to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). During this period, subjects were required to discontinue use of all nonstudy drugs used for the treatment of chronic pain and no supplemental analgesic medications were allowed. Subjects who did not tolerate BTDS 5 were discontinued from the study.
595650|NCT00531427|E2|Reported Event|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
595651|NCT00531427|E1|Reported Event|Double-blind BTDS|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
595652|NCT00531284|B18|Baseline|Total|Total of all reporting groups
595654|NCT00531284|B16|Baseline|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595655|NCT00531284|B15|Baseline|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595656|NCT00531284|B14|Baseline|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595657|NCT00531284|B13|Baseline|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595658|NCT00531284|B12|Baseline|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595659|NCT00531284|B11|Baseline|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595660|NCT00531284|B10|Baseline|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595661|NCT00531284|B9|Baseline|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595662|NCT00531284|B8|Baseline|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595663|NCT00531284|B7|Baseline|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595664|NCT00531284|B6|Baseline|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595665|NCT00531284|B5|Baseline|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595666|NCT00531284|B4|Baseline|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595667|NCT00531284|B3|Baseline|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595668|NCT00531284|B2|Baseline|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595669|NCT00531284|B1|Baseline|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595670|NCT00531284|P17|Participant Flow|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595690|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
608004|NCT00502775|O1|Outcome|Placebo|
595671|NCT00531284|P16|Participant Flow|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595672|NCT00531284|P15|Participant Flow|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595673|NCT00531284|P14|Participant Flow|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595674|NCT00531284|P13|Participant Flow|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595675|NCT00531284|P12|Participant Flow|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595676|NCT00531284|P11|Participant Flow|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595677|NCT00531284|P10|Participant Flow|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595678|NCT00531284|P9|Participant Flow|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595679|NCT00531284|P8|Participant Flow|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595680|NCT00531284|P7|Participant Flow|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595681|NCT00531284|P6|Participant Flow|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595682|NCT00531284|P5|Participant Flow|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595683|NCT00531284|P4|Participant Flow|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595684|NCT00531284|P3|Participant Flow|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595685|NCT00531284|P2|Participant Flow|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595686|NCT00531284|P1|Participant Flow|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595687|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595688|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595689|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595691|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595692|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595693|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595694|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595695|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595696|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595697|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595698|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595699|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595700|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595701|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595702|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595703|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595704|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595705|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595706|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595707|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595708|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595709|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595710|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595711|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595712|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595713|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595714|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595715|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595716|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595717|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595718|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595719|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595720|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595721|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595722|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595723|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595724|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
595725|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
595726|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
595778|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595727|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595728|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595729|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595730|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595731|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595732|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595733|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595734|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595735|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595736|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595737|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595738|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595739|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595740|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595741|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595742|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595743|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595914|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595744|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595745|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595746|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595747|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595748|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595749|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595750|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595751|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595752|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595753|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595754|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595755|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595756|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595757|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595758|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595759|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595760|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595915|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
608005|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
595761|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595762|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595763|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595764|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595765|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595766|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595767|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595768|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595769|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595770|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595771|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595772|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595773|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595774|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595775|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595776|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595777|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595970|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595779|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595780|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595781|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595782|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595783|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595784|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595785|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595786|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595787|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595788|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595789|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595790|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595791|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595792|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595793|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595794|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595795|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595916|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595796|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595797|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595798|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595799|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595800|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595801|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595802|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595803|NCT00531284|O1|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment.
595804|NCT00531284|O14|Outcome|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595805|NCT00531284|O13|Outcome|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595806|NCT00531284|O12|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595807|NCT00531284|O11|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595808|NCT00531284|O10|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595809|NCT00531284|O9|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595810|NCT00531284|O8|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595811|NCT00531284|O7|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595812|NCT00531284|O6|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595813|NCT00531284|O5|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
596066|NCT00530894|P3|Participant Flow|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
595814|NCT00531284|O4|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595815|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595816|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595817|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595818|NCT00531284|E17|Reported Event|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595819|NCT00531284|E16|Reported Event|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595820|NCT00531284|E15|Reported Event|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595821|NCT00531284|E14|Reported Event|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595822|NCT00531284|E13|Reported Event|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595823|NCT00531284|E12|Reported Event|P1B MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595824|NCT00531284|E11|Reported Event|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595825|NCT00531284|E10|Reported Event|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595826|NCT00531284|E9|Reported Event|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595827|NCT00531284|E8|Reported Event|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595828|NCT00531284|E7|Reported Event|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595829|NCT00531284|E6|Reported Event|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595830|NCT00531284|E5|Reported Event|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595917|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
596067|NCT00530894|P2|Participant Flow|High Risk: SAVR|Surgical Aortic Valve Replacement
595831|NCT00531284|E4|Reported Event|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595832|NCT00531284|E3|Reported Event|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595833|NCT00531284|E2|Reported Event|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595834|NCT00531284|E1|Reported Event|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
595835|NCT00531206|B1|Baseline|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595836|NCT00531206|P1|Participant Flow|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595837|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595838|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595839|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595840|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595841|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595842|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595843|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595844|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595845|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595846|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595847|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595848|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595849|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595850|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595851|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595852|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595853|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595854|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595855|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595856|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595857|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595858|NCT00531206|E1|Reported Event|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
595859|NCT00531050|B7|Baseline|Total|Total of all reporting groups
595860|NCT00531050|B6|Baseline|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595880|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595861|NCT00531050|B5|Baseline|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595862|NCT00531050|B4|Baseline|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595863|NCT00531050|B3|Baseline|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595864|NCT00531050|B2|Baseline|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595865|NCT00531050|B1|Baseline|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595866|NCT00531050|P6|Participant Flow|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595867|NCT00531050|P5|Participant Flow|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595881|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595882|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595918|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595868|NCT00531050|P4|Participant Flow|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595869|NCT00531050|P3|Participant Flow|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595870|NCT00531050|P2|Participant Flow|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595871|NCT00531050|P1|Participant Flow|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
595872|NCT00531050|O6|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595873|NCT00531050|O5|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595874|NCT00531050|O4|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595875|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595876|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595877|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595878|NCT00531050|O3|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595879|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595911|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595883|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595884|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595885|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595886|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595887|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595888|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595889|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595890|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595891|NCT00531050|E6|Reported Event|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595892|NCT00531050|E5|Reported Event|Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595893|NCT00531050|E4|Reported Event|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
595894|NCT00531050|E3|Reported Event|Part 1:Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595895|NCT00531050|E2|Reported Event|Part 1:Salmeterol 50mcg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595896|NCT00531050|E1|Reported Event|Part 1:Indacaterol 300mcg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
595897|NCT00531011|B3|Baseline|Total|Total of all reporting groups
595898|NCT00531011|B2|Baseline|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595899|NCT00531011|B1|Baseline|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595900|NCT00531011|P2|Participant Flow|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595901|NCT00531011|P1|Participant Flow|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595902|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595903|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595904|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595905|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595906|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595907|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595908|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595909|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595910|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595919|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595920|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595921|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595922|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595923|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595924|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595925|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595926|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595927|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595928|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595929|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595930|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595931|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595932|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595933|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595934|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595935|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595936|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595937|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595938|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595939|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595940|NCT00531011|E2|Reported Event|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
595941|NCT00531011|E1|Reported Event|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
595942|NCT00530946|B5|Baseline|Total|Total of all reporting groups
595943|NCT00530946|B4|Baseline|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595944|NCT00530946|B3|Baseline|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595945|NCT00530946|B2|Baseline|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595946|NCT00530946|B1|Baseline|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595947|NCT00530946|P4|Participant Flow|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595948|NCT00530946|P3|Participant Flow|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595949|NCT00530946|P2|Participant Flow|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595950|NCT00530946|P1|Participant Flow|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595951|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595952|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595953|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595954|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595955|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595956|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595957|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595958|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595959|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595960|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595961|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595962|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595963|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595964|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595965|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595966|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595967|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
608006|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
595971|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595972|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595973|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595974|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595975|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595976|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595977|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595978|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595979|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595980|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595981|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595982|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595983|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595984|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595985|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595986|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595987|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595988|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595989|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595990|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595991|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595992|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595993|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595994|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595995|NCT00530946|E4|Reported Event|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
595996|NCT00530946|E3|Reported Event|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
595997|NCT00530946|E2|Reported Event|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
595998|NCT00530946|E1|Reported Event|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
595999|NCT00530920|B4|Baseline|Total|Total of all reporting groups
596000|NCT00530920|B3|Baseline|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596001|NCT00530920|B2|Baseline|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596002|NCT00530920|B1|Baseline|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596003|NCT00530920|P3|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596004|NCT00530920|P2|Participant Flow|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
596005|NCT00530920|P1|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596006|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596007|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596008|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596009|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596010|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596011|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596012|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596013|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596014|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596015|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596016|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596017|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596018|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596068|NCT00530894|P1|Participant Flow|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596019|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596020|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596021|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596022|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596023|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596024|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596025|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596026|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596027|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596028|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596029|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596030|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596031|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596032|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596033|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596034|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596035|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596036|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596037|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596038|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596039|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596040|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596041|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596042|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596043|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596044|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596045|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596046|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596047|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596048|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596049|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596050|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596051|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596052|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596053|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596054|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596055|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596056|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596057|NCT00530920|E3|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
596058|NCT00530920|E2|Reported Event|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
596059|NCT00530920|E1|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
596060|NCT00530894|B5|Baseline|Total|Total of all reporting groups
596061|NCT00530894|B4|Baseline|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596062|NCT00530894|B3|Baseline|Inoperable TAVR|Edwards SAPIEN Transcatheter Heart Valve
596063|NCT00530894|B2|Baseline|High Risk: SAVR|Surgical Valve Replacement
596064|NCT00530894|B1|Baseline|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596065|NCT00530894|P4|Participant Flow|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596069|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596070|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596071|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
596072|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596073|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596074|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596075|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
596076|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596077|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596078|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596079|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
596080|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596081|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596082|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596083|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
596084|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596085|NCT00530894|O2|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596086|NCT00530894|O1|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596087|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596088|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596089|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
596090|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596091|NCT00530894|E4|Reported Event|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
596092|NCT00530894|E3|Reported Event|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596093|NCT00530894|E2|Reported Event|High Risk: SAVR|Surgical Aortic Valve Replacement
596094|NCT00530894|E1|Reported Event|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
596095|NCT00530855|B1|Baseline|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
596096|NCT00530855|P1|Participant Flow|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
596097|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
596098|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
596099|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
596100|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
596101|NCT00530855|E1|Reported Event|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
596102|NCT00530842|B3|Baseline|Total|Total of all reporting groups
596103|NCT00530842|B2|Baseline|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
596104|NCT00530842|B1|Baseline|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
596105|NCT00530842|P2|Participant Flow|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
596106|NCT00530842|P1|Participant Flow|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
596107|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596108|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596109|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596110|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596111|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596112|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596113|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596114|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596115|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596116|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596117|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596118|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596119|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596120|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596121|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596122|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596123|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596124|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596125|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596126|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596127|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596128|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596129|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596130|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596131|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596132|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596135|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596136|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596137|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596138|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596139|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596140|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596141|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596142|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596143|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596144|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596145|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596146|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596147|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596148|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596149|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596150|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596151|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596152|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596153|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596154|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596155|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596156|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596157|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596158|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596159|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596160|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596161|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596162|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596163|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596164|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596165|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596166|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596167|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596168|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596169|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596170|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596171|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596172|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596173|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596174|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596175|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596176|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596177|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596178|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596179|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596180|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596181|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596182|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596183|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596184|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596185|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596186|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596187|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596188|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596189|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596190|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596191|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596192|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596193|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596194|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596195|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596196|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596197|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
608007|NCT00502775|O1|Outcome|Placebo|
596198|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596199|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596200|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596201|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596202|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596203|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596204|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596205|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596206|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596207|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596208|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596209|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596210|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596211|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596212|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596213|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596214|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596215|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596216|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596217|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596218|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596219|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596220|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596221|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596222|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596223|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
596224|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
596225|NCT00530842|E4|Reported Event|Fluticasone + Salmeterol (Period 2)|Flu+Sal 500+50mcg b.i.d. in Period 2
596226|NCT00530842|E3|Reported Event|Fluticasone + Salmeterol (Period 1)|Flu+Sal 500+50mcg b.i.d. in Period 1
596227|NCT00530842|E2|Reported Event|Tiotropium + Salmeterol (Period 2)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 2
596228|NCT00530842|E1|Reported Event|Tiotropium + Salmeterol (Period 1)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1
596229|NCT00530816|B4|Baseline|Total|Total of all reporting groups
596230|NCT00530816|B3|Baseline|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
596231|NCT00530816|B2|Baseline|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596232|NCT00530816|B1|Baseline|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596233|NCT00530816|P3|Participant Flow|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
596234|NCT00530816|P2|Participant Flow|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596235|NCT00530816|P1|Participant Flow|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596236|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596237|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596238|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596239|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596240|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596241|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596361|NCT00530504|O1|Outcome|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
596242|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596243|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596244|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596245|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596246|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596247|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596248|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596249|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596250|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596251|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596252|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596253|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596254|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596255|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596256|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596257|NCT00530816|E3|Reported Event|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
596258|NCT00530816|E2|Reported Event|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596259|NCT00530816|E1|Reported Event|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
596260|NCT00530790|B1|Baseline|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596261|NCT00530790|P1|Participant Flow|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596262|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596263|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596264|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596265|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596266|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596267|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596268|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596269|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596270|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596271|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596272|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596273|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596274|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596275|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596276|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596277|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596278|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596279|NCT00530790|E1|Reported Event|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
596280|NCT00530777|B3|Baseline|Total|Total of all reporting groups
596281|NCT00530777|B2|Baseline|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
596282|NCT00530777|B1|Baseline|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
596283|NCT00530777|P2|Participant Flow|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
596284|NCT00530777|P1|Participant Flow|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
596285|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
596286|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
596287|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
596288|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
596289|NCT00530777|E2|Reported Event|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
596290|NCT00530777|E1|Reported Event|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
596291|NCT00530764|B5|Baseline|Total|Total of all reporting groups
596292|NCT00530764|B4|Baseline|Placebo|Range of 1-16 sprays per day of placebo spray
596293|NCT00530764|B3|Baseline|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596447|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596294|NCT00530764|B2|Baseline|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596295|NCT00530764|B1|Baseline|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596296|NCT00530764|P4|Participant Flow|Placebo|Range of 1-16 sprays per day of placebo spray
596297|NCT00530764|P3|Participant Flow|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596298|NCT00530764|P2|Participant Flow|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596299|NCT00530764|P1|Participant Flow|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596300|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596301|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596302|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596303|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596304|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596305|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596306|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596307|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596308|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596309|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596310|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596311|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596312|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596313|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596314|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596315|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596316|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596317|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596318|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596319|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596320|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596321|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596322|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596323|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596324|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596325|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596326|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596488|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596327|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596328|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596329|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596330|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596331|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596332|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
596333|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596334|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596335|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596336|NCT00530764|E4|Reported Event|Placebo|Range of 1-16 sprays per day of placebo spray
596337|NCT00530764|E3|Reported Event|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
596338|NCT00530764|E2|Reported Event|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
596339|NCT00530764|E1|Reported Event|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
596340|NCT00530712|B1|Baseline|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
596341|NCT00530712|P1|Participant Flow|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
596342|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596343|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596344|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596345|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596346|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596347|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596348|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596349|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596350|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596351|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596352|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
596353|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596354|NCT00530712|E1|Reported Event|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
596355|NCT00530634|B1|Baseline|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
596356|NCT00530634|P1|Participant Flow|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
596357|NCT00530634|O1|Outcome|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
596358|NCT00530634|E1|Reported Event|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
596359|NCT00530504|B1|Baseline|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
596360|NCT00530504|P1|Participant Flow|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
596362|NCT00530504|E1|Reported Event|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
596363|NCT00530439|B3|Baseline|Total|Total of all reporting groups
596364|NCT00530439|B2|Baseline|Control|
596365|NCT00530439|B1|Baseline|Lifestyle Intervention|physical activity, dietetic counselling
596366|NCT00530439|P2|Participant Flow|Control|
596367|NCT00530439|P1|Participant Flow|Lifestyle Intervention|physical activity, dietetic counselling
596368|NCT00530439|O2|Outcome|Control|
596369|NCT00530439|O1|Outcome|Lifestyle Intervention|physical activity, dietetic counselling
596370|NCT00530439|E2|Reported Event|Control|
596371|NCT00530439|E1|Reported Event|Lifestyle Intervention|physical activity, dietetic counselling
596372|NCT00530348|B3|Baseline|Total|Total of all reporting groups
596373|NCT00530348|B2|Baseline|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596374|NCT00530348|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596375|NCT00530348|P2|Participant Flow|Alemtuzumab|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596376|NCT00530348|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596377|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596378|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596379|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596380|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596381|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596382|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596383|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596384|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596385|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596386|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596387|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596388|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596389|NCT00530348|E2|Reported Event|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
596390|NCT00530348|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
596391|NCT00530335|B1|Baseline|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596392|NCT00530335|P1|Participant Flow|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596393|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596394|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596395|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596396|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596397|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596398|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596399|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596400|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596401|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596489|NCT00530023|E2|Reported Event|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596402|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596403|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596404|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596405|NCT00530335|E1|Reported Event|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
596406|NCT00530270|B3|Baseline|Total|Total of all reporting groups
596407|NCT00530270|B2|Baseline|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596408|NCT00530270|B1|Baseline|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596409|NCT00530270|P2|Participant Flow|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596410|NCT00530270|P1|Participant Flow|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596411|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596412|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596413|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596414|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596415|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596416|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596417|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596418|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596419|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596420|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596421|NCT00530270|E2|Reported Event|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596422|NCT00530270|E1|Reported Event|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
596423|NCT00530257|B1|Baseline|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
596424|NCT00530257|P1|Participant Flow|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
596425|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596426|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596427|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596490|NCT00530023|E1|Reported Event|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596491|NCT00529802|B1|Baseline|Everolimus|All patients were to receive 10mg everolimus (RAD001) daily.
596492|NCT00529802|P1|Participant Flow|Everolimus|All patients were to receive 10mg everolimus (RAD001) daily.
596428|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596429|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596430|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596431|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596432|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596433|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596434|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596435|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596436|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596437|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596438|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596439|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596440|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596441|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
596442|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed.
596443|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596444|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596445|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596446|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596567|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
596448|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
596449|NCT00530257|E2|Reported Event|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
596450|NCT00530257|E1|Reported Event|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
596451|NCT00530218|B1|Baseline|All Study Participants|Blood Culture at Day 21 or later -or- PCR Test at Day 21 or later
596452|NCT00530218|P1|Participant Flow|All Study Participants|Patients undergo intervention with intravenous ganciclovir followed by oral ganciclovir, if cytomegalovirus reactivation is detected.
596453|NCT00530218|O1|Outcome|Compliance Among Patients With CMV Reactivation|Patients with CMV reactivation detected by blood culture or PCR test.
596454|NCT00530218|O1|Outcome|All Study Participants|Blood Culture at Day 21 or later -or- PCR Test at Day 21 or later
596455|NCT00530218|O1|Outcome|CMV Reactivation Patients With GCV|CMV reactivation patients with intravenous Ganciclovir followed by oral Ganciclovir.
596456|NCT00530218|E2|Reported Event|Patients Without CMV Reactivation Detected|No CMV Positive Blood Culture at Day 21 or later -and- No CMV Positive PCR Test at Day 21 or later
596457|NCT00530218|E1|Reported Event|Patients With CMV Reactivation Detected|CMV Positive Blood Culture at Day 21 or later -or- CMV Positive PCR Test at Day 21 or later
596458|NCT00530088|B1|Baseline|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
596459|NCT00530088|P1|Participant Flow|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
596460|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
596461|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
596462|NCT00530088|E1|Reported Event|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
596463|NCT00530075|B1|Baseline|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596464|NCT00530075|P1|Participant Flow|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596465|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596466|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596467|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596468|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596469|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596470|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596471|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596472|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596473|NCT00530075|E1|Reported Event|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
596474|NCT00530023|B3|Baseline|Total|Total of all reporting groups
596475|NCT00530023|B2|Baseline|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596476|NCT00530023|B1|Baseline|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596477|NCT00530023|P2|Participant Flow|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596478|NCT00530023|P1|Participant Flow|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596479|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596480|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596481|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596482|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596483|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596484|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596485|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596486|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
596487|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
596493|NCT00529802|O1|Outcome|Patients Evaluable for Secondary Outcome|Patients who had two FDG-PET scans completed, one at baseline and one after 2 weeks of treatment, were evaluable for secondary outcome.
596494|NCT00529802|O2|Outcome|High Uptake|"High uptake of FDG-PET defined as avgSUVmax>4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the standardized uptake value) ."
596495|NCT00529802|O1|Outcome|Low Uptake|"Low uptake FDG-PET is defined as avgSUVmax<=4; avgSUVmax is the average across all measured lesions of each lesion's maximum SUV (SUV is the standardized uptake value) ."
596496|NCT00529802|E1|Reported Event|Everolimus|"All patients were to receive 10mg everolimus (RAD001) daily.~These results are based on n=56 patients who were evaluable for toxicity."
596497|NCT00529789|B1|Baseline|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596498|NCT00529789|P1|Participant Flow|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596499|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596500|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596501|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596502|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596503|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596504|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596505|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596506|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596507|NCT00529789|O5|Outcome|Duloxetine - 120 mg|120 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
596508|NCT00529789|O4|Outcome|Duloxetine Dose - 90 mg|90 milligrams (mg) every day (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
596509|NCT00529789|O3|Outcome|Duloxetine - 60 mg|60 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
596510|NCT00529789|O2|Outcome|Duloxetine Dose - 30 mg|30 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
596511|NCT00529789|O1|Outcome|Duloxetine Dose - 20 mg|20 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up.
596512|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596513|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596514|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596515|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596516|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596517|NCT00529789|E2|Reported Event|Duloxetine - Period IV|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) between Weeks 18 - 30; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596518|NCT00529789|E1|Reported Event|Duloxetine - Period II/III|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 18 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
596519|NCT00529763|B4|Baseline|Total|Total of all reporting groups
596520|NCT00529763|B3|Baseline|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596568|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596569|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
596521|NCT00529763|B2|Baseline|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596522|NCT00529763|B1|Baseline|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596523|NCT00529763|P3|Participant Flow|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596524|NCT00529763|P2|Participant Flow|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596525|NCT00529763|P1|Participant Flow|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596526|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
596527|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
596528|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
596529|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
596530|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
596531|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
596532|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
596533|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
596534|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
596535|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
596536|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
596537|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
596538|NCT00529763|O3|Outcome|Blast Phase CML/Ph+ ALL|Participants with MyBP or LyBP CML or Ph+ALL who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
596539|NCT00529763|O2|Outcome|Accelerated CML|Participants with Ph+ AP who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance.Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
596540|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with Ph+ CP CML who have received prior treatment with Imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants with chronic phase CML with QD dosing were permitted to take their dose either in the morning or evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
596541|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596542|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596543|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596544|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
608008|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
596545|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596546|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596547|NCT00529763|O3|Outcome|Total|All treated Participants with Advanced Disease CML - Accelerated Phase (AP) and Blast Phase/PH+ ALL
596548|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596549|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596550|NCT00529763|O1|Outcome|CP CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596551|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596552|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596553|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596554|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596555|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596556|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596557|NCT00529763|E3|Reported Event|Chronic Phase|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596558|NCT00529763|E2|Reported Event|Blast Phase / Ph+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596559|NCT00529763|E1|Reported Event|Accelerated Phase|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
596560|NCT00529659|B3|Baseline|Total|Total of all reporting groups
596561|NCT00529659|B2|Baseline|Placebo|Placebo administered orally twice daily.
596562|NCT00529659|B1|Baseline|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596563|NCT00529659|P2|Participant Flow|Placebo|Placebo administered orally twice daily.
596564|NCT00529659|P1|Participant Flow|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596565|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
596566|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596570|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596571|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
596572|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596573|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
596574|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596575|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
596576|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596577|NCT00529659|E2|Reported Event|Placebo|Placebo administered orally twice daily.
596578|NCT00529659|E1|Reported Event|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
596579|NCT00529633|B3|Baseline|Total|Total of all reporting groups
596580|NCT00529633|B2|Baseline|Placebo|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Placebo for a period of 24 weeks."
596581|NCT00529633|B1|Baseline|Thalidomide|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.100 mg by mouth at night for 4 weeks; then if tolerated, Thalidomid will be increased to 200 mg by mouth at night for 20 weeks; for a total of 24 weeks on Thalidomid"
596582|NCT00529633|P2|Participant Flow|Thalidomide|"End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.~Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP~Thalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks"
596583|NCT00529633|P1|Participant Flow|Placebo|"This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.~Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of >85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program"
596584|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
596585|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
596586|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
596587|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
596588|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
596589|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
596590|NCT00529633|E2|Reported Event|Placebo|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.
596591|NCT00529633|E1|Reported Event|Thalidomide|"Patients will receive Thalidomide for a period of 24 weeks. Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP.~Thalidomide : 100 mg by mouth at night for 4 weeks; 200 mg by mouth at night for 20 weeks"
596592|NCT00529568|B3|Baseline|Total|Total of all reporting groups
596593|NCT00529568|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596594|NCT00529568|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596595|NCT00529568|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596596|NCT00529568|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596614|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596597|NCT00529568|P1|Participant Flow|Eltrombopag: Open-label Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the Open-label Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
596598|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596599|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596600|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596601|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596602|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596603|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596604|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596605|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596606|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596607|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596608|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596609|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596610|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596611|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596612|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596613|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596615|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596616|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596617|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596618|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596619|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596620|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596621|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596622|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596623|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596624|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596625|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596626|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596627|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596628|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596629|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596630|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596631|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596632|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596633|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596655|NCT00529555|E2|Reported Event|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
597412|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
596634|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596635|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596636|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
596637|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
596638|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
596639|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596640|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596641|NCT00529568|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596642|NCT00529568|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
596643|NCT00529568|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of &lt;75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained &lt;100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
596644|NCT00529555|B4|Baseline|Total|Total of all reporting groups
596645|NCT00529555|B3|Baseline|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
596646|NCT00529555|B2|Baseline|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
596647|NCT00529555|B1|Baseline|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
596648|NCT00529555|P3|Participant Flow|Scaling and Root Planing + Vehicle|Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing
596649|NCT00529555|P2|Participant Flow|Scaling & Root Planing + Periocline Gel|"Gel WITH Minocycline HCL 2.1% + Scaling & root planing~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
596650|NCT00529555|P1|Participant Flow|Scaling and Root Planing + SHAM TX|Empty syringe + Scaling and root planing
596651|NCT00529555|O3|Outcome|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
596652|NCT00529555|O2|Outcome|Scaling and Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
596653|NCT00529555|O1|Outcome|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
596654|NCT00529555|E3|Reported Event|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
596656|NCT00529555|E1|Reported Event|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
596657|NCT00529542|B3|Baseline|Total|Total of all reporting groups
596658|NCT00529542|B2|Baseline|Placebo|Placebo qd
596659|NCT00529542|B1|Baseline|Atorvastatin|Atorvastatin, 40 mg qd
596660|NCT00529542|P2|Participant Flow|Placebo|Placebo qd
596661|NCT00529542|P1|Participant Flow|Atorvastatin|Atorvastatin, 40 mg qd
596662|NCT00529542|O2|Outcome|Placebo|Placebo qd
596663|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596664|NCT00529542|O2|Outcome|Placebo|Placebo qd
596665|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596666|NCT00529542|O2|Outcome|Placebo|Placebo qd
596667|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596668|NCT00529542|O2|Outcome|Placebo|Placebo qd
596669|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596670|NCT00529542|O2|Outcome|Placebo|Placebo qd
596671|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596672|NCT00529542|O2|Outcome|Placebo|Placebo qd
596673|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596674|NCT00529542|O2|Outcome|Placebo|Placebo qd
596675|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596676|NCT00529542|O2|Outcome|Placebo|Placebo qd
596677|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596678|NCT00529542|O2|Outcome|Placebo|Placebo qd
596679|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596680|NCT00529542|O2|Outcome|Placebo|Placebo qd
596681|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596682|NCT00529542|O2|Outcome|Placebo|Placebo qd
596683|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596684|NCT00529542|O2|Outcome|Placebo|Placebo qd
596685|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596686|NCT00529542|O2|Outcome|Placebo|Placebo qd
596687|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596688|NCT00529542|O2|Outcome|Placebo|Placebo qd
596689|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596690|NCT00529542|O2|Outcome|Placebo|Placebo qd
596691|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596692|NCT00529542|O2|Outcome|Placebo|Placebo qd
596693|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596694|NCT00529542|O2|Outcome|Placebo|Placebo qd
596695|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596696|NCT00529542|O2|Outcome|Placebo|Placebo qd
596697|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
596698|NCT00529542|E2|Reported Event|Placebo|Placebo qd
596699|NCT00529542|E1|Reported Event|Atorvastatin|Atorvastatin, 40 mg qd
596700|NCT00529529|B4|Baseline|Total|Total of all reporting groups
596701|NCT00529529|B3|Baseline|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596702|NCT00529529|B2|Baseline|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596703|NCT00529529|B1|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596704|NCT00529529|P3|Participant Flow|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596705|NCT00529529|P2|Participant Flow|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596706|NCT00529529|P1|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596784|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596841|NCT00529464|O3|Outcome|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
596707|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596708|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596709|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596710|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596711|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596712|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596713|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596714|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596715|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596716|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596717|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596718|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596719|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
597999|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
596720|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596721|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596722|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596723|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596724|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596725|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596726|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596727|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596728|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596729|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596730|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596731|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596732|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
598000|NCT00527787|E2|Reported Event|Naproxen|Naproxen 500 mg
596733|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596734|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596735|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596736|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596737|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596738|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596739|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596740|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596741|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596742|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596743|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596744|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596745|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
598001|NCT00527787|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
596746|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596747|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596748|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596749|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596750|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596751|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596752|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596753|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596754|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596755|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596756|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596757|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596758|NCT00529529|E3|Reported Event|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
598187|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
596759|NCT00529529|E2|Reported Event|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596760|NCT00529529|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
596761|NCT00529516|B4|Baseline|Total|Total of all reporting groups
596762|NCT00529516|B3|Baseline|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596763|NCT00529516|B2|Baseline|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596764|NCT00529516|B1|Baseline|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596765|NCT00529516|P3|Participant Flow|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596766|NCT00529516|P2|Participant Flow|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596767|NCT00529516|P1|Participant Flow|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596768|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596769|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596770|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596771|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596772|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596773|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596774|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596775|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596776|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596777|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596778|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596779|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596780|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596781|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596782|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596783|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596969|NCT00529126|B4|Baseline|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
596785|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596786|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596787|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596788|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596789|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596790|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596791|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596792|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596793|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596794|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596795|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596796|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596797|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596798|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596799|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596800|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596801|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596802|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596803|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596804|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596805|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596806|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596807|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596808|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596809|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596810|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596811|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596812|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596813|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596814|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596815|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596816|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596817|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596818|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596819|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596820|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596821|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596822|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596823|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596824|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596825|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596826|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596827|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596828|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596829|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596830|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596831|NCT00529516|E3|Reported Event|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596832|NCT00529516|E2|Reported Event|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
596833|NCT00529516|E1|Reported Event|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
596834|NCT00529464|B4|Baseline|Total|Total of all reporting groups
596835|NCT00529464|B3|Baseline|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
596836|NCT00529464|B2|Baseline|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
596837|NCT00529464|B1|Baseline|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
596838|NCT00529464|P3|Participant Flow|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
596839|NCT00529464|P2|Participant Flow|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
596840|NCT00529464|P1|Participant Flow|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
596842|NCT00529464|O2|Outcome|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
596843|NCT00529464|O1|Outcome|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
596844|NCT00529464|E3|Reported Event|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
596845|NCT00529464|E2|Reported Event|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
596846|NCT00529464|E1|Reported Event|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
596847|NCT00529451|B5|Baseline|Total|Total of all reporting groups
596848|NCT00529451|B4|Baseline|Ramipril 5 mg|Ramipril 5 mg once daily
596849|NCT00529451|B3|Baseline|Aliskiren 75 mg|Aliskiren 75 mg once daily
596850|NCT00529451|B2|Baseline|Aliskiren 150 mg|Aliskiren 150 mg once daily
596851|NCT00529451|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily
596852|NCT00529451|P4|Participant Flow|Ramipril 5 mg|Ramipril 5 mg once daily
596853|NCT00529451|P3|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg once daily
596854|NCT00529451|P2|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg once daily
596855|NCT00529451|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily
596856|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
596857|NCT00529451|O1|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
596858|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
596859|NCT00529451|O1|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
596860|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
596861|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
596862|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
596863|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
596864|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
596865|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
596866|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
596867|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
596868|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
596869|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
596870|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
596871|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
596872|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
596873|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
596874|NCT00529451|E4|Reported Event|Ramipril 5 mg|Ramipril 5 mg once daily
596875|NCT00529451|E3|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg once daily
596876|NCT00529451|E2|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg once daily
596877|NCT00529451|E1|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg once daily
596878|NCT00529399|B4|Baseline|Total|Total of all reporting groups
596879|NCT00529399|B3|Baseline|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596880|NCT00529399|B2|Baseline|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
596881|NCT00529399|B1|Baseline|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596882|NCT00529399|P3|Participant Flow|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596883|NCT00529399|P2|Participant Flow|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
596884|NCT00529399|P1|Participant Flow|GAD-alum|"3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596885|NCT00529399|O3|Outcome|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596886|NCT00529399|O2|Outcome|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
596887|NCT00529399|O1|Outcome|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596888|NCT00529399|E3|Reported Event|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596933|NCT00529204|B1|Baseline|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
596889|NCT00529399|E2|Reported Event|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
596890|NCT00529399|E1|Reported Event|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
596891|NCT00529308|B3|Baseline|Total|Total of all reporting groups
596892|NCT00529308|B2|Baseline|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596893|NCT00529308|B1|Baseline|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596894|NCT00529308|P2|Participant Flow|Sham|
596895|NCT00529308|P1|Participant Flow|Active rTMS|
596896|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596897|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596898|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596899|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596900|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596901|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596902|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596903|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596904|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596905|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596906|NCT00529308|E2|Reported Event|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596907|NCT00529308|E1|Reported Event|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
596908|NCT00529282|B3|Baseline|Total|Total of all reporting groups
596909|NCT00529282|B2|Baseline|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
596910|NCT00529282|B1|Baseline|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
596911|NCT00529282|P2|Participant Flow|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
596912|NCT00529282|P1|Participant Flow|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
596913|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
596914|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
596915|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
596916|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
596917|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
596918|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
596919|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
596920|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
596921|NCT00529282|E2|Reported Event|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
596922|NCT00529282|E1|Reported Event|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
596923|NCT00529243|B1|Baseline|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
596924|NCT00529243|P1|Participant Flow|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
596925|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
596926|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
596927|NCT00529243|E1|Reported Event|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
596928|NCT00529217|B1|Baseline|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
596929|NCT00529217|P1|Participant Flow|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
596930|NCT00529217|O1|Outcome|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
596931|NCT00529217|O1|Outcome|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
596932|NCT00529217|E1|Reported Event|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
596968|NCT00529126|B5|Baseline|Total|Total of all reporting groups
596934|NCT00529204|P1|Participant Flow|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
596935|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
596936|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
596937|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
596938|NCT00529204|E1|Reported Event|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
596939|NCT00529191|B3|Baseline|Total|Total of all reporting groups
596940|NCT00529191|B2|Baseline|Placebo|Placebo treatment
596941|NCT00529191|B1|Baseline|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
596942|NCT00529191|P2|Participant Flow|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
596943|NCT00529191|P1|Participant Flow|Atorvastatin|Two out of every 3 patients will receive atorvastatin in tablet form. The subject will start on 10mg of atorvastatin daily for four weeks, and then titrate up to 20mg daily. There will be 12 months of treatment followed by 6 months of a washout period.
596944|NCT00529191|O4|Outcome|Placebo YES Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
596945|NCT00529191|O3|Outcome|Atorvastatin YES Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
596946|NCT00529191|O2|Outcome|Placebo NO Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
596947|NCT00529191|O1|Outcome|Atorvastatin NO Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
596948|NCT00529191|O2|Outcome|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
596949|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
596950|NCT00529191|O2|Outcome|Placebo|"Participants in placebo arm who had hypoglycemic episodes requiring treatment~Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period."
596951|NCT00529191|O1|Outcome|Atorvastatin|"Participants in Atorvastatin arm who had hypoglycemic episodes requiring treatment~Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
596952|NCT00529191|O2|Outcome|Placebo|"Participants in placebo arm who had hypoglycemic episodes requiring treatment~Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period."
596953|NCT00529191|O1|Outcome|Atorvastatin|"Participants in Atorvastatin arm who had hypoglycemic episodes requiring treatment~Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
596954|NCT00529191|O2|Outcome|Placebo|"One out of three subjects will receive a placebo.~Placebo: One out of three subjects will receive a placebo."
596955|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
596956|NCT00529191|O2|Outcome|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
596957|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
596958|NCT00529191|O2|Outcome|Placebo|Placebo treatment
596959|NCT00529191|O1|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
596960|NCT00529191|O2|Outcome|Placebo|Placebo treatment
596961|NCT00529191|O1|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
596962|NCT00529191|E2|Reported Event|Placebo|Placebo treatment
596963|NCT00529191|E1|Reported Event|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
596964|NCT00529152|B1|Baseline|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
596965|NCT00529152|P1|Participant Flow|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
596966|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
596967|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
596970|NCT00529126|B3|Baseline|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596971|NCT00529126|B2|Baseline|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596972|NCT00529126|B1|Baseline|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596973|NCT00529126|P4|Participant Flow|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
596974|NCT00529126|P3|Participant Flow|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596975|NCT00529126|P2|Participant Flow|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596976|NCT00529126|P1|Participant Flow|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596977|NCT00529126|O4|Outcome|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
596978|NCT00529126|O3|Outcome|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596979|NCT00529126|O2|Outcome|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596980|NCT00529126|O1|Outcome|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596981|NCT00529126|E4|Reported Event|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
596982|NCT00529126|E3|Reported Event|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596983|NCT00529126|E2|Reported Event|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596984|NCT00529126|E1|Reported Event|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
596985|NCT00529100|B4|Baseline|Total|Total of all reporting groups
596986|NCT00529100|B3|Baseline|Pemetrexed/Cisplatin/Radiation Phase 2|Participants were strictly in Phase 2. Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m2 IV.
596987|NCT00529100|B2|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1-Phase 2|Participants were overlap in Phase 1 and Phase 2.
596988|NCT00529100|B1|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1|Participants were strictly in Phase 1. Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
596989|NCT00529100|P2|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
596990|NCT00529100|P1|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (every 3 weeks [q3 weeks]) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
596991|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
596992|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
596993|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
596994|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
596995|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
597032|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
596996|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
596997|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
596998|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed 500 mg/m^2 as determined by phase 1 trial on Days 1 and 22; concurrent cisplatin 20 mg/m^2 as determined by phase 1 trial with cycles commencing on Days 1 and 22; two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m2.
596999|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on days 1-5 and 22-26 for cohort four. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
597000|NCT00529100|E3|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
597001|NCT00529100|E2|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1-2|"Cohort 4 data from Phase (Ph) 1 was included in the Ph 2 analysis as Cohort 4 was the established dose from Ph 1.~Ph 1: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first 3 cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.~Ph 2: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus from Ph 1 trial on Days 1 and 22; concurrent cisplatin from Ph 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2."
597002|NCT00529100|E1|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
597003|NCT00529087|B4|Baseline|Total|Total of all reporting groups
597004|NCT00529087|B3|Baseline|Placebo (Double-blind)|Once daily for weeks 1 through 4
597005|NCT00529087|B2|Baseline|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
597006|NCT00529087|B1|Baseline|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
597007|NCT00529087|P3|Participant Flow|Placebo (Double-blind)|Once daily for weeks 1 through 4
597008|NCT00529087|P2|Participant Flow|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
597009|NCT00529087|P1|Participant Flow|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
597010|NCT00529087|O3|Outcome|Placebo|Once daily
597011|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597012|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597013|NCT00529087|O3|Outcome|Placebo|Once daily
597014|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597015|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597016|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
597017|NCT00529087|O3|Outcome|Placebo|Once daily
597018|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597019|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597020|NCT00529087|O3|Outcome|Placebo|Once daily
597021|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597022|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597023|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
597024|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
597025|NCT00529087|O3|Outcome|Placebo|Once daily
597026|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597027|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597028|NCT00529087|O3|Outcome|Placebo|Once daily
597029|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597030|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597031|NCT00529087|O3|Outcome|Placebo|Once daily
597035|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597036|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597037|NCT00529087|O3|Outcome|Placebo|Once daily
597038|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597039|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597040|NCT00529087|O3|Outcome|Placebo|Once daily
597041|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597042|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597043|NCT00529087|O3|Outcome|Placebo|Once daily
597044|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597045|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597046|NCT00529087|O3|Outcome|Placebo|Once daily
597047|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597048|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597049|NCT00529087|O4|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
597050|NCT00529087|O3|Outcome|Placebo|Once daily
597051|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day, Placebo once daily on alternating days
597052|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597053|NCT00529087|O3|Outcome|Placebo|Once daily
597054|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597055|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597056|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
597057|NCT00529087|O3|Outcome|Placebo|Once daily
597058|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597059|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597060|NCT00529087|O2|Outcome|Placebo|Once daily
597061|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 12 mg once daily (QD) and MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
597062|NCT00529087|O4|Outcome|Placebo QD|Once daily
597063|NCT00529087|O3|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
597064|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), with placebo once daily on alternating days
597065|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
597066|NCT00529087|O2|Outcome|Placebo|Once daily
597067|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 QD treatment group (12 mg every day) and MOA-728 QOD treatment group (12 mg once every other day, with placebo once daily on alternating days).
597068|NCT00529087|E4|Reported Event|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) for weeks 5 through 12
597069|NCT00529087|E3|Reported Event|Placebo (Double-blind)|Once daily for weeks 1 through 4
597070|NCT00529087|E2|Reported Event|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
597071|NCT00529087|E1|Reported Event|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
597072|NCT00529035|B1|Baseline|Group 1|
597073|NCT00529035|P1|Participant Flow|Ultra-low Dose Interleukin-2|"Daily subcutaneous administration of Interleukin-2 evaluated at three dose levels:~Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/M^2/day"
597074|NCT00529035|O3|Outcome|Median Treg:Tcon Ratio at Week 12|Immune-cell ratio after a 4 weeks off IL-2 per protocol
597075|NCT00529035|O2|Outcome|Median Treg:Tcon Ratio at Week 8|Immune-cell ratio after 8 weeks of IL-2 therapy
597076|NCT00529035|O1|Outcome|Median Treg:Tcon Ratio at Baseline|Immune-cell ratio before the start of IL-2 therapy
597077|NCT00529035|O3|Outcome|Median Absolute Cell Count at Week 12|Immune-cell counts after a 4 weeks off IL-2 per protocol
597078|NCT00529035|O2|Outcome|Median Absolute Cell Counts at Week 8|Immune-cell counts after 8 weeks of IL-2 therapy
597079|NCT00529035|O1|Outcome|Median Absolute Cell Counts at Baseline|Immune-cell counts before the start of IL-2 therapy
597080|NCT00529035|O1|Outcome|Ultra-low Dose Interleukin-2|
597081|NCT00529035|O1|Outcome|Ultra-low Dose IL-2 MTD|
597082|NCT00529035|E1|Reported Event|Ultra-low Dose Interleukin-2|
597083|NCT00528957|B3|Baseline|Total|Total of all reporting groups
597084|NCT00528957|B2|Baseline|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597085|NCT00528957|B1|Baseline|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597086|NCT00528957|P2|Participant Flow|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597087|NCT00528957|P1|Participant Flow|Tenofovir DF|Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597088|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597089|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597090|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597091|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597092|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597093|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597094|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597095|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597096|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597097|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597098|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597099|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597100|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597101|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597102|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597103|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597104|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597105|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597106|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597107|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597108|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597109|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597110|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597111|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597112|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597113|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597114|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597115|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597116|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597117|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597118|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597119|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
597120|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
597121|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597122|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597123|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597124|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597125|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597126|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597127|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597128|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597129|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597130|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597131|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597367|NCT00528606|P2|Participant Flow|Placebo|Placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597132|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597133|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597134|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597135|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597136|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597137|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597138|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597139|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597140|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597141|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597142|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597143|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597144|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597145|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597146|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597147|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597148|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597149|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597150|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597151|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597152|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
597153|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
597154|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597155|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597156|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597157|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597158|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597159|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597160|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597161|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597162|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597163|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597164|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597165|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597166|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597167|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597168|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597169|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597170|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597171|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597172|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597173|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597174|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597175|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597176|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597177|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597178|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597179|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597180|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597181|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597182|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
597183|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597184|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597185|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
597186|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
597187|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597188|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597189|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597190|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597191|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597192|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597193|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597194|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597195|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597196|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597197|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597198|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597199|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597200|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597201|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597202|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597203|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597204|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597205|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597206|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597207|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597208|NCT00528957|O3|Outcome|All TDF|All participants who received TDF in the randomized and/or extension phases (All TDF group)
597209|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597210|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597211|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group)
597212|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
598380|NCT00526994|O3|Outcome|Control|no screen and no referral
597213|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
597214|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597215|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
597216|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
597217|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
597218|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
597219|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
597220|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
597221|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597222|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
597223|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
597224|NCT00528957|E3|Reported Event|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
597225|NCT00528957|E2|Reported Event|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
597226|NCT00528957|E1|Reported Event|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
597227|NCT00528931|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
597228|NCT00528931|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
597229|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
597230|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
597231|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
597232|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
597233|NCT00528931|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
597234|NCT00528931|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
597235|NCT00528879|B5|Baseline|Total|Total of all reporting groups
597236|NCT00528879|B4|Baseline|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597237|NCT00528879|B3|Baseline|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597238|NCT00528879|B2|Baseline|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597239|NCT00528879|B1|Baseline|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597240|NCT00528879|P4|Participant Flow|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597241|NCT00528879|P3|Participant Flow|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597242|NCT00528879|P2|Participant Flow|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597243|NCT00528879|P1|Participant Flow|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597244|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597245|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597246|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597247|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597248|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597249|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597250|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597251|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597252|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597253|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597254|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597255|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597256|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597257|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597258|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597259|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597260|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597261|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597262|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597263|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597264|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597265|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597266|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597267|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597268|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597269|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597270|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597271|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597272|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597273|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597274|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597275|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597276|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597277|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597278|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597279|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597280|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597281|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597282|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597283|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597284|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597285|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597286|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597287|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597288|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597289|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597290|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597291|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597292|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
598464|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
597293|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597294|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597295|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597296|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597297|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597298|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597299|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597300|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597301|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597302|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597303|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597304|NCT00528879|E4|Reported Event|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597305|NCT00528879|E3|Reported Event|Dapagliflozin, 5.0 mg + Metformin|Participants received dapagliflozin, 5.0 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597306|NCT00528879|E2|Reported Event|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597307|NCT00528879|E1|Reported Event|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
597308|NCT00528866|B1|Baseline|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597309|NCT00528866|P1|Participant Flow|Androgen Suppression + RT + Docetaxel|Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597310|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597311|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597312|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597313|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597314|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597315|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597316|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597317|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597318|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597319|NCT00528866|E1|Reported Event|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
597320|NCT00528840|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597321|NCT00528840|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597322|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597323|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597324|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597325|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597326|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597327|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597328|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597329|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597330|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597331|NCT00528840|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597333|NCT00528801|B2|Baseline|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
597334|NCT00528801|B1|Baseline|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
597335|NCT00528801|P2|Participant Flow|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
597336|NCT00528801|P1|Participant Flow|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
597337|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
597338|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
597339|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
597340|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
597341|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
597342|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
597343|NCT00528801|E2|Reported Event|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
597344|NCT00528801|E1|Reported Event|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
597345|NCT00528788|B1|Baseline|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol : 2 or 4 mcg"
597346|NCT00528788|P1|Participant Flow|Pre Doxercalciferol/Post Doxercalciferol|"all end stage renal disease patients with secondary hyperparathyroidism who are vitamin D naive~compared pre- and post doxercalciferol."
597347|NCT00528788|O1|Outcome|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol"
597348|NCT00528788|E1|Reported Event|Pre and Post Doxicalciferol|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol 2 mcg or 4 mcg three times per week for 1 month"
597349|NCT00528775|B1|Baseline|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597350|NCT00528775|P1|Participant Flow|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597351|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597352|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597353|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597354|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597355|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597356|NCT00528775|E1|Reported Event|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
597357|NCT00528645|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
597358|NCT00528645|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
597359|NCT00528645|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks"
597360|NCT00528645|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks"
597361|NCT00528645|O1|Outcome|Treatment (Saracatinib)|saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
597362|NCT00528645|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks"
597363|NCT00528645|E1|Reported Event|Treatment (Saracatinib)|saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
597364|NCT00528606|B3|Baseline|Total|Total of all reporting groups
597365|NCT00528606|B2|Baseline|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597366|NCT00528606|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597368|NCT00528606|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597369|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597370|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597371|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597372|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597373|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597374|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597375|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597376|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597377|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597378|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597379|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597380|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597381|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597382|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597383|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597384|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597385|NCT00528606|O2|Outcome|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597386|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597387|NCT00528606|E2|Reported Event|Placebo|placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597388|NCT00528606|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597389|NCT00528567|B3|Baseline|Total|Total of all reporting groups
597390|NCT00528567|B2|Baseline|Chemotherapy|Participants randomized to receive chemotherapy alone
597391|NCT00528567|B1|Baseline|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597392|NCT00528567|P2|Participant Flow|Chemotherapy|"Participants randomized to receive chemotherapy alone.~For patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
597393|NCT00528567|P1|Participant Flow|Bevacizumab and Chemotherapy|"Participants randomized to receive bevacizumab and chemotherapy.~For these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
597394|NCT00528567|O4|Outcome|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, more than 18 months after first dose
597395|NCT00528567|O3|Outcome|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, more than 18 months after first dose
597396|NCT00528567|O2|Outcome|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, 0-18 months after first dose
597397|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, 0-18 months after first dose
597398|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597399|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597400|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597401|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597402|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597403|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597404|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597405|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597406|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597407|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597408|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597409|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597410|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
597411|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597413|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597414|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
597415|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597416|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597417|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597418|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597419|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597420|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
597421|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597422|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
597423|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597424|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
597425|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
597426|NCT00528567|E4|Reported Event|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, during follow-up period (>18 months) after first dose
597427|NCT00528567|E3|Reported Event|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (>18 months) after first dose
597428|NCT00528567|E2|Reported Event|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose
597429|NCT00528567|E1|Reported Event|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose
597430|NCT00528541|B3|Baseline|Total|Total of all reporting groups
597431|NCT00528541|B2|Baseline|Dysport®|botulinum toxin type A (Dysport®)
597432|NCT00528541|B1|Baseline|BOTOX®|botulinum toxin type A (BOTOX®)
597433|NCT00528541|P2|Participant Flow|Dysport®|botulinum toxin type A (Dysport®)
597434|NCT00528541|P1|Participant Flow|BOTOX®|botulinum toxin type A (BOTOX®)
597435|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597436|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597437|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597438|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597439|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597440|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597441|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597442|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597443|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597444|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597445|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597446|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597447|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597448|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597449|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597450|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597451|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
597452|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
597453|NCT00528541|E2|Reported Event|Dysport®|botulinum toxin type A (Dysport®)
597454|NCT00528541|E1|Reported Event|BOTOX®|botulinum toxin type A (BOTOX®)
597455|NCT00528528|B5|Baseline|Total|Total of all reporting groups
597456|NCT00528528|B4|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597457|NCT00528528|B3|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597458|NCT00528528|B2|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597459|NCT00528528|B1|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597460|NCT00528528|P4|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597461|NCT00528528|P3|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597508|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597509|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597462|NCT00528528|P2|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597463|NCT00528528|P1|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597464|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597465|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597466|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597467|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597468|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597469|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597470|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597471|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597472|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597473|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597474|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597475|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597476|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597477|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597478|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597479|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597480|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597510|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597511|NCT00528424|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597481|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597482|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597483|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597484|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597485|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597486|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597487|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597488|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597489|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597490|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597491|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597492|NCT00528528|E4|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597493|NCT00528528|E3|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597494|NCT00528528|E2|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
597495|NCT00528528|E1|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
597496|NCT00528450|B1|Baseline|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
597497|NCT00528450|P1|Participant Flow|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
597498|NCT00528450|O1|Outcome|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
597499|NCT00528450|E1|Reported Event|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
597500|NCT00528424|B1|Baseline|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597501|NCT00528424|P1|Participant Flow|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
597502|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597503|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597504|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597505|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597506|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597507|NCT00528424|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints
597513|NCT00528411|B3|Baseline|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597514|NCT00528411|B2|Baseline|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597515|NCT00528411|B1|Baseline|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses
597516|NCT00528411|P3|Participant Flow|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
597517|NCT00528411|P2|Participant Flow|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses
597518|NCT00528411|P1|Participant Flow|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
597519|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597520|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597521|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597522|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597523|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597524|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597525|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597526|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597527|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597528|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597529|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597530|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597531|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597532|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597533|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597534|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597535|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597536|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597537|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597538|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597539|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597540|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597541|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597542|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597543|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597544|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597545|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597546|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597547|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597548|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597549|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597550|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597551|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597552|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597553|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597554|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597555|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597556|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597557|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597558|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597559|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597560|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597561|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597562|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597563|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597564|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597565|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597566|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597567|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597568|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597569|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597570|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597571|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597572|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597573|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597574|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597575|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597576|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597577|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597578|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597579|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597580|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597581|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597582|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597583|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597584|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597585|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597586|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597587|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597588|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597589|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597590|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597591|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597592|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597593|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597594|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597595|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597596|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597597|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597598|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597599|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597600|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
608009|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
597601|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597602|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597603|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597604|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597605|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597606|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597607|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597608|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597609|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597610|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597611|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597612|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597613|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597614|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597615|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597616|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597617|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597618|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597619|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597620|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597621|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597622|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597623|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597624|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597625|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597626|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597627|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597628|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597629|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597630|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597631|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597632|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597633|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597634|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597635|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597636|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597637|NCT00528411|E3|Reported Event|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597638|NCT00528411|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
597639|NCT00528411|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
597640|NCT00528398|B1|Baseline|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
597641|NCT00528398|P1|Participant Flow|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
597642|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
597643|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
597644|NCT00528398|E1|Reported Event|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
597645|NCT00528372|B10|Baseline|Total|Total of all reporting groups
597795|NCT00528112|P2|Participant Flow|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
608010|NCT00502775|O1|Outcome|Placebo|
597646|NCT00528372|B9|Baseline|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597647|NCT00528372|B8|Baseline|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597648|NCT00528372|B7|Baseline|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597649|NCT00528372|B6|Baseline|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597650|NCT00528372|B5|Baseline|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597651|NCT00528372|B4|Baseline|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597652|NCT00528372|B3|Baseline|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597653|NCT00528372|B2|Baseline|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597654|NCT00528372|B1|Baseline|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597655|NCT00528372|P9|Participant Flow|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597656|NCT00528372|P8|Participant Flow|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597657|NCT00528372|P7|Participant Flow|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597658|NCT00528372|P6|Participant Flow|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597659|NCT00528372|P5|Participant Flow|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597660|NCT00528372|P4|Participant Flow|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597661|NCT00528372|P3|Participant Flow|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597662|NCT00528372|P2|Participant Flow|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597663|NCT00528372|P1|Participant Flow|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597664|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597665|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597666|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597667|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597668|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597669|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597670|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597671|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597672|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597673|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597674|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597675|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597676|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597677|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597678|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597679|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597680|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597681|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597682|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, PM, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597683|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597684|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597685|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597686|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597766|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597687|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597688|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597689|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597690|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597691|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597692|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597693|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597694|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597695|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597696|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597697|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo, AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597698|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597699|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597700|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597701|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597702|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597703|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597704|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597705|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597706|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597843|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597707|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597708|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597709|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597710|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597711|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597712|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597713|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597714|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597715|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597716|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597717|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597718|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597719|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597720|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597721|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597722|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597723|NCT00528372|O3|Outcome|Group 1: Dapaglifozon, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597724|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597725|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597726|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
598135|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
597727|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597728|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597729|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597730|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597731|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597732|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|"Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597733|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597734|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597735|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597736|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597737|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597738|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597739|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597740|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597741|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597742|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597743|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597744|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597745|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597844|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597746|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597747|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597748|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597749|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597750|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597751|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597752|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597753|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597754|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597755|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597756|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597757|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597758|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597759|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597760|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597761|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597762|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
597763|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597764|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597765|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
608011|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
597767|NCT00528372|E7|Reported Event|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597768|NCT00528372|E6|Reported Event|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597769|NCT00528372|E5|Reported Event|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597770|NCT00528372|E4|Reported Event|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597771|NCT00528372|E3|Reported Event|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597772|NCT00528372|E2|Reported Event|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
597773|NCT00528372|E1|Reported Event|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
597774|NCT00528268|B3|Baseline|Total|Total of all reporting groups
597775|NCT00528268|B2|Baseline|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597776|NCT00528268|B1|Baseline|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597777|NCT00528268|P2|Participant Flow|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597778|NCT00528268|P1|Participant Flow|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597779|NCT00528268|O2|Outcome|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597780|NCT00528268|O1|Outcome|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597781|NCT00528268|E2|Reported Event|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597782|NCT00528268|E1|Reported Event|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
597783|NCT00528190|B3|Baseline|Total|Total of all reporting groups
597784|NCT00528190|B2|Baseline|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
597785|NCT00528190|B1|Baseline|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
597786|NCT00528190|P2|Participant Flow|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
597787|NCT00528190|P1|Participant Flow|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
597788|NCT00528190|O2|Outcome|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
597789|NCT00528190|O1|Outcome|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
597790|NCT00528190|E2|Reported Event|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
597791|NCT00528190|E1|Reported Event|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
597792|NCT00528112|B3|Baseline|Total|Total of all reporting groups
597793|NCT00528112|B2|Baseline|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597794|NCT00528112|B1|Baseline|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597845|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597796|NCT00528112|P1|Participant Flow|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
597797|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597798|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597799|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597800|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597801|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597802|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597803|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597804|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597805|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597806|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597807|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597808|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597809|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597810|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597811|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597812|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597813|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597814|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597815|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597816|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597817|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597818|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597819|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597820|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597821|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597822|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597823|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597824|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597825|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597826|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597827|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597828|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597829|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597830|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597831|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597832|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597833|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597834|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597835|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597836|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597837|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597838|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597839|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597840|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597841|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
597842|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
597846|NCT00528112|E3|Reported Event|LCS16, up to 5 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
597847|NCT00528112|E2|Reported Event|LCS16, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.
597848|NCT00528112|E1|Reported Event|LCS12, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
597849|NCT00528021|B5|Baseline|Total|Total of all reporting groups
597850|NCT00528021|B4|Baseline|Vehicle|
597851|NCT00528021|B3|Baseline|12.5% BGC20-0582|
597852|NCT00528021|B2|Baseline|10% BGC20-0582|
597853|NCT00528021|B1|Baseline|2.5% BGC20-0582|
597854|NCT00528021|P4|Participant Flow|Vehicle|
597855|NCT00528021|P3|Participant Flow|12.5% BGC20-0582|
597856|NCT00528021|P2|Participant Flow|10% BGC20-0582|
597857|NCT00528021|P1|Participant Flow|2.5% BGC20-0582|
597858|NCT00528021|O4|Outcome|Vehicle|
597859|NCT00528021|O3|Outcome|12.5% BGC20-0582|
597860|NCT00528021|O2|Outcome|10% BGC20-0582|
597861|NCT00528021|O1|Outcome|2.5% BGC20-0582|
597862|NCT00528021|E4|Reported Event|Vehicle|
597863|NCT00528021|E3|Reported Event|12.5% BGC20-0582|
597864|NCT00528021|E2|Reported Event|10% BGC20-0582|
597865|NCT00528021|E1|Reported Event|2.5% BGC20-0582|
597866|NCT00527982|B3|Baseline|Total|Total of all reporting groups
597867|NCT00527982|B2|Baseline|No Treatment|
597868|NCT00527982|B1|Baseline|Celecoxib Treatment|Celecoxib 600 mg orally daily
597869|NCT00527982|P2|Participant Flow|No Treatment|
597870|NCT00527982|P1|Participant Flow|Celecoxib Treatment|Celecoxib 600 mg orally daily
597871|NCT00527982|O2|Outcome|No Treatment|
597872|NCT00527982|O1|Outcome|Celecoxib Treatment|Celecoxib 600 mg orally daily
597873|NCT00527982|E2|Reported Event|No Treatment|
597874|NCT00527982|E1|Reported Event|Celecoxib Treatment|Celecoxib 600 mg orally daily
597875|NCT00527943|B3|Baseline|Total|Total of all reporting groups
597876|NCT00527943|B2|Baseline|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597877|NCT00527943|B1|Baseline|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597878|NCT00527943|P2|Participant Flow|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597879|NCT00527943|P1|Participant Flow|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597880|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597881|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597882|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597883|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597884|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597885|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597886|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597887|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597888|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597889|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597890|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597891|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597892|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597893|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597894|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597895|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597896|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597897|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597898|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597899|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597900|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597901|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597902|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597903|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597904|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597905|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597906|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597907|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597908|NCT00527943|E2|Reported Event|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597909|NCT00527943|E1|Reported Event|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
597910|NCT00527904|B1|Baseline|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
597911|NCT00527904|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
597912|NCT00527904|O1|Outcome|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
597913|NCT00527904|E1|Reported Event|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
597914|NCT00527878|B1|Baseline|Patients|
597915|NCT00527878|P2|Participant Flow|Ranitidine/Placebo|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive ranitidine for 12 months followed by 12 months of the ranitidine.
597916|NCT00527878|P1|Participant Flow|Placebo/Ranitidine|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive placebo for 12 months followed by 12 months of the ranitidine.
597996|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
608012|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
597917|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
597918|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
597919|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
597920|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
597921|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
597922|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
597923|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
597924|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
597925|NCT00527878|E2|Reported Event|Ranitidine|This was a crossover study and patients received 12 months of ranitidine and 12 months of placebo, unless they terminated the study.
597926|NCT00527878|E1|Reported Event|Placebo|this was a crossover study and patients received both placebo and study drug (ranitidine), both of which for 12 months, unless they terminated the study.
597927|NCT00527826|B3|Baseline|Total|Total of all reporting groups
597928|NCT00527826|B2|Baseline|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597929|NCT00527826|B1|Baseline|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597930|NCT00527826|P2|Participant Flow|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597931|NCT00527826|P1|Participant Flow|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597932|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597933|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597934|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597935|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597936|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597937|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597938|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597939|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597940|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597941|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597942|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597943|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597944|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597945|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597946|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597947|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597948|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597949|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597950|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597951|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597997|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597952|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597953|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597954|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597955|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597956|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597957|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597958|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597959|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597960|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597961|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597962|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597963|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597964|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597965|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
597966|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597967|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597968|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597969|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597970|NCT00527826|O3|Outcome|FP 500 µg|Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
597971|NCT00527826|O2|Outcome|Sal 50 µg|Salmeterol xinafoate (Sal) 50 µg BID (morning and evening) from a separate inhaler (SEVERENT Diskus)
597972|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597973|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597974|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597975|NCT00527826|E2|Reported Event|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
597976|NCT00527826|E1|Reported Event|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
597977|NCT00527787|B3|Baseline|Total|Total of all reporting groups
597978|NCT00527787|B2|Baseline|Naproxen|Naproxen 500 mg
597979|NCT00527787|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597980|NCT00527787|P2|Participant Flow|Naproxen|Naproxen 500 mg
597981|NCT00527787|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597982|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
597983|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597984|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
597985|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597986|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
597987|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597988|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
597989|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597990|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
597991|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597992|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
597993|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
597994|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
597995|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
598002|NCT00527748|B1|Baseline|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks."
598003|NCT00527748|P1|Participant Flow|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
598004|NCT00527748|O1|Outcome|Standard of Care|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
598005|NCT00527748|E1|Reported Event|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
598006|NCT00527735|B4|Baseline|Total|Total of all reporting groups
598007|NCT00527735|B3|Baseline|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598008|NCT00527735|B2|Baseline|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598009|NCT00527735|B1|Baseline|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598010|NCT00527735|P3|Participant Flow|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598011|NCT00527735|P2|Participant Flow|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598136|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
608013|NCT00502775|O1|Outcome|Placebo|
598012|NCT00527735|P1|Participant Flow|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598013|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598014|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598015|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598016|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598017|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598018|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598019|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598020|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598021|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598186|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598022|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598023|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598024|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598025|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598026|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598027|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598028|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598029|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598030|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598031|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598062|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598032|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598033|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598034|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598035|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598036|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598037|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598038|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598039|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598040|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598041|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598125|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
608014|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
598042|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598043|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598044|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598045|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598046|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598047|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598048|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598049|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598050|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598051|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598126|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598052|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598053|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598054|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598055|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598056|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598057|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598058|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598059|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598060|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598061|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598127|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598063|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598064|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598065|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598066|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598067|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598068|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598069|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598070|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598071|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598072|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598128|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598073|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598074|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598075|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598076|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598077|NCT00527735|E6|Reported Event|Placebo + Paclitaxel/Carboplatin SCLC|During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598078|NCT00527735|E5|Reported Event|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC|During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598079|NCT00527735|E4|Reported Event|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC|During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598080|NCT00527735|E3|Reported Event|Placebo + Paclitaxel/Carboplatin NSCLC|During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
598081|NCT00527735|E2|Reported Event|Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC|During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598129|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598130|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598131|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598132|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598133|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598134|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
608015|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
598082|NCT00527735|E1|Reported Event|Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC|During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
598083|NCT00527722|B3|Baseline|Total|Total of all reporting groups
598084|NCT00527722|B2|Baseline|No Pleural Plug|The standard lung biopsy without placement of the plug.
598085|NCT00527722|B1|Baseline|Pleural Plug|Experimental lung plug after the lung biopsy.
598086|NCT00527722|P2|Participant Flow|No Pleural Plug|The standard lung biopsy without placement of the plug.
598087|NCT00527722|P1|Participant Flow|Pleural Plug|Experimental lung plug after the lung biopsy.
598088|NCT00527722|O2|Outcome|No Pleural Plug|The standard lung biopsy without placement of the plug.
598089|NCT00527722|O1|Outcome|Pleural Plug|Experimental lung plug after the lung biopsy.
598090|NCT00527722|E2|Reported Event|No Pleural Plug|The standard lung biopsy without placement of the plug.
598091|NCT00527722|E1|Reported Event|Pleural Plug|Experimental lung plug after the lung biopsy.
598092|NCT00527644|B1|Baseline|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
598093|NCT00527644|P1|Participant Flow|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
598094|NCT00527644|O1|Outcome|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
598095|NCT00527644|O1|Outcome|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
598096|NCT00527644|E1|Reported Event|Spring Clips|"Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.~5mm spring clip: Microline Pentax 5mm Visu-Loc Clip Applier"
598097|NCT00527618|B1|Baseline|Entire Study Population|This includes all 34 participants who were randomized. A subset of 28 participants were included in the analysis since only 28 participants contributed samples on both arms of the crossover study.
598098|NCT00527618|P2|Participant Flow|Valacyclovir Followed by Acyclovir|Valacyclovir 1000 mg twice daily, followed by a two-week washout period, then acyclovir 400 mg twice daily
598099|NCT00527618|P1|Participant Flow|Acyclovir Followed by Valacyclovir|Acyclovir 400 mg twice daily, followed by a two-week washout period, then valacyclovir 1000 mg twice daily
598100|NCT00527618|O1|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily
598101|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
598102|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
598103|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
598104|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
598105|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
598106|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
598107|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
598108|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
598109|NCT00527618|E2|Reported Event|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
598110|NCT00527618|E1|Reported Event|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
598111|NCT00527605|B3|Baseline|Total|Total of all reporting groups
598112|NCT00527605|B2|Baseline|Placebo|Matching oral placebo once a day for 6 months
598113|NCT00527605|B1|Baseline|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598114|NCT00527605|P2|Participant Flow|Placebo|Matching oral placebo once a day for 6 months
598115|NCT00527605|P1|Participant Flow|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598116|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598117|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598118|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598119|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598120|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598121|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598122|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598123|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598124|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598137|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598138|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598139|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598140|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598141|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598142|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598143|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598144|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598145|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598146|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
598147|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598148|NCT00527605|E2|Reported Event|Placebo|Matching oral placebo once a day for 6 months
598149|NCT00527605|E1|Reported Event|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
598150|NCT00527592|B1|Baseline|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
598151|NCT00527592|P1|Participant Flow|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
598152|NCT00527592|O2|Outcome|Latanoprost|One drop in the study eye, single dose
598153|NCT00527592|O1|Outcome|Travoprost|One drop in the study eye, single dose
598154|NCT00527592|E2|Reported Event|Latanoprost|One drop in the study eye, single dose
598155|NCT00527592|E1|Reported Event|Travoprost|One drop in the study eye, single dose
598156|NCT00527566|B1|Baseline|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598157|NCT00527566|P1|Participant Flow|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598158|NCT00527566|O2|Outcome|Non-treatment Phase|The non-treatment phase consists of the wash-out phase and the safety monitoring phase.
598159|NCT00527566|O1|Outcome|Mepolizumab (Treatment Phase)|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598160|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598161|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598162|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598163|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598164|NCT00527566|E1|Reported Event|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
598165|NCT00527514|B1|Baseline|Amlodipine and Olmesartan, if Necessary|Week 1-3 all participants: Amlodipine 5mg; Week 4-6 Amlodipine 5 mg/olmesartan 20 mg if mean SBP >= 120/80 mm Hg; Week 7-9 Amlodipine 5 mg/ olmesartan 40 mg if mean SBP >= 120/80 mm Hg; Week 10-12 Amlodipine 10 mg/olmesartan 40 mg if mean SBP >= 120/80 mm Hg
598166|NCT00527514|P1|Participant Flow|Amlodipine and Olmesartan, if Necessary|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
598167|NCT00527514|O1|Outcome|Group 4 - Aml 10 mg + Olm 40 mg|
598168|NCT00527514|O1|Outcome|Group 3 - Aml 5 mg + Olm 40 mg|Participants from Group 2 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 40mg.
598169|NCT00527514|O1|Outcome|Group 2 - Aml 5 mg + Olmesartan 20 mg|Participants from Group 1 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 20 mg.
598170|NCT00527514|O1|Outcome|Group 1 Amlodipine 5 mg|All participants started the Active Treatment period with 5 mg of amlodipine for 3 weeks.
598171|NCT00527514|O1|Outcome|Overall Active Treatment Period|
598172|NCT00527514|O1|Outcome|Overall Active Treatment Period|
598173|NCT00527514|E4|Reported Event|Amlodipine 10 mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
598174|NCT00527514|E3|Reported Event|Amlodipine 5mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
598175|NCT00527514|E2|Reported Event|Amlodipine 5mg and Olmesartan 20 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
598176|NCT00527514|E1|Reported Event|Amlodipine 5 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
598177|NCT00527488|B5|Baseline|Total|Total of all reporting groups
598178|NCT00527488|B4|Baseline|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598179|NCT00527488|B3|Baseline|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598180|NCT00527488|B2|Baseline|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598181|NCT00527488|B1|Baseline|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598182|NCT00527488|P4|Participant Flow|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598183|NCT00527488|P3|Participant Flow|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598184|NCT00527488|P2|Participant Flow|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598185|NCT00527488|P1|Participant Flow|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
608016|NCT00502775|O1|Outcome|Placebo|
598188|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598189|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598190|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598191|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598192|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598193|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598194|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598195|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598196|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598197|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598198|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598199|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598200|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598201|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598202|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598203|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598204|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598205|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598206|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598207|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598208|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598209|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598210|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598211|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598212|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598213|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598214|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598215|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598216|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598217|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598218|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598219|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598220|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598221|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598222|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598223|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598224|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598225|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598226|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598227|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598228|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598229|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598230|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598231|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598232|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598233|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598234|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598235|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598236|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598237|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598238|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598239|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598240|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598241|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598242|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598243|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598244|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598245|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598246|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598247|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598248|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598249|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598250|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
598251|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598252|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598253|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598254|NCT00527488|E4|Reported Event|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
608017|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
598255|NCT00527488|E3|Reported Event|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
598256|NCT00527488|E2|Reported Event|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
598257|NCT00527488|E1|Reported Event|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
598258|NCT00527475|B3|Baseline|Total|Total of all reporting groups
598259|NCT00527475|B2|Baseline|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
598260|NCT00527475|B1|Baseline|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
598261|NCT00527475|P2|Participant Flow|Reduced Fluence PDT & Ranibizumab|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
598262|NCT00527475|P1|Participant Flow|Ranibizumab|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
598263|NCT00527475|O2|Outcome|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
598264|NCT00527475|O1|Outcome|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
598265|NCT00527475|E2|Reported Event|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
598266|NCT00527475|E1|Reported Event|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
598267|NCT00527423|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
598268|NCT00527423|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
598269|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
598270|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152 (end of treatment), and a 4-week follow-up visit at week 156 (end of study). Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
598271|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
598272|NCT00527423|E1|Reported Event|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
598273|NCT00527397|B1|Baseline|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
598274|NCT00527397|P1|Participant Flow|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
598275|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
598276|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
598277|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
598278|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
598279|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
598280|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
598281|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
598282|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
598283|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
598284|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
598285|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
598286|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
598287|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
598288|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
598289|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
598290|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
598291|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
598292|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
598293|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
598294|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
598295|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
598296|NCT00527397|E1|Reported Event|All Subjects With Type 1 or Type 2 Diabetes Mellitus|all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
598297|NCT00527332|B3|Baseline|Total|Total of all reporting groups
598298|NCT00527332|B2|Baseline|General Anesthesia|General anesthesia
598299|NCT00527332|B1|Baseline|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
598300|NCT00527332|P2|Participant Flow|General Anesthesia|General anesthesia
598301|NCT00527332|P1|Participant Flow|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
598302|NCT00527332|O2|Outcome|General Anesthesia|General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
598303|NCT00527332|O1|Outcome|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
598304|NCT00527332|E2|Reported Event|General Anesthesia|General anesthesia
598305|NCT00527332|E1|Reported Event|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
598306|NCT00527319|B4|Baseline|Total|Total of all reporting groups
598307|NCT00527319|B3|Baseline|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
598308|NCT00527319|B2|Baseline|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
598309|NCT00527319|B1|Baseline|Group A, Control Group|Supportive care only
598310|NCT00527319|P3|Participant Flow|Group C, High Dose VT-122|VT-122 high dose Supportive care
598311|NCT00527319|P2|Participant Flow|Group B, Low Dose VT-122|VT-122 low dose Supportive care
598312|NCT00527319|P1|Participant Flow|Group A, Control Group|Supportive care only
598313|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
598314|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
598315|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
598316|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
598317|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
598318|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
598319|NCT00527319|E3|Reported Event|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
598320|NCT00527319|E2|Reported Event|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
598321|NCT00527319|E1|Reported Event|Group A, Control Group|Supportive care only
598322|NCT00527124|B3|Baseline|Total|Total of all reporting groups
598323|NCT00527124|B2|Baseline|Arm II|Patients receive docetaxel and prednisone as in arm I.
598324|NCT00527124|B1|Baseline|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
598325|NCT00527124|P2|Participant Flow|Arm II|Patients receive docetaxel and prednisone as in arm I.
598326|NCT00527124|P1|Participant Flow|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
598327|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
598328|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
598329|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
598330|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
598331|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
608018|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
598332|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
598333|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
598334|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
598335|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
598336|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
598337|NCT00527124|E2|Reported Event|Arm II|Patients receive docetaxel and prednisone as in arm I.
598338|NCT00527124|E1|Reported Event|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
598339|NCT00527111|B3|Baseline|Total|Total of all reporting groups
598340|NCT00527111|B2|Baseline|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598341|NCT00527111|B1|Baseline|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598342|NCT00527111|P2|Participant Flow|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598343|NCT00527111|P1|Participant Flow|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598344|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598345|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598346|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598347|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598348|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598349|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598350|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598351|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598352|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598353|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598354|NCT00527111|E2|Reported Event|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
598355|NCT00527111|E1|Reported Event|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
598356|NCT00527098|B3|Baseline|Total|Total of all reporting groups
598357|NCT00527098|B2|Baseline|Standard of Care|Routine Standard of Care Resuscitation Fluid
598358|NCT00527098|B1|Baseline|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
598359|NCT00527098|P2|Participant Flow|Standard of Care|Routine Standard of Care Resuscitation Fluid
598360|NCT00527098|P1|Participant Flow|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
598361|NCT00527098|O1|Outcome|Observational|This is an observational trial.
598362|NCT00527098|E2|Reported Event|Standard of Care|Routine Standard of Care Resuscitation Fluid
598363|NCT00527098|E1|Reported Event|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
598364|NCT00527072|B1|Baseline|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
598365|NCT00527072|P1|Participant Flow|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
598366|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
598367|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
598368|NCT00527072|O1|Outcome|Infliximab|Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
598369|NCT00527072|E1|Reported Event|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
598370|NCT00526994|B4|Baseline|Total|Total of all reporting groups
598371|NCT00526994|B3|Baseline|Control|no screen and no referral
598372|NCT00526994|B2|Baseline|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
598373|NCT00526994|B1|Baseline|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
598374|NCT00526994|P3|Participant Flow|Control|no screen and no referral
598375|NCT00526994|P2|Participant Flow|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
598376|NCT00526994|P1|Participant Flow|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
598377|NCT00526994|O3|Outcome|Control|no screen and no referral
598378|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
598379|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
608019|NCT00502775|O1|Outcome|Placebo|
598381|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
598382|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
598383|NCT00526994|O3|Outcome|Control|no screen and no referral
598384|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
598385|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
598386|NCT00526994|O3|Outcome|Control|no screen and no referral
598387|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
598388|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
598389|NCT00526994|E3|Reported Event|Control|no screen and no referral
598390|NCT00526994|E2|Reported Event|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
598391|NCT00526994|E1|Reported Event|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
598392|NCT00526890|B1|Baseline|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598393|NCT00526890|P1|Participant Flow|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598394|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598395|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598396|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598397|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598398|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598399|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598400|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598401|NCT00526890|E1|Reported Event|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
598402|NCT00526799|B3|Baseline|Total|Total of all reporting groups
598403|NCT00526799|B2|Baseline|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
598404|NCT00526799|B1|Baseline|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
598405|NCT00526799|P2|Participant Flow|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
598406|NCT00526799|P1|Participant Flow|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
598407|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
598408|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
598409|NCT00526799|O1|Outcome|Phase I & II|"Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily during phase II.~During phase I:~Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
598410|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
598411|NCT00526799|O1|Outcome|Phase I Participants|Phase I Participants evaluable for MTD
598412|NCT00526799|E1|Reported Event|Phase I/Phase II|All Phase I/Phase II participants
598413|NCT00526669|B1|Baseline|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598414|NCT00526669|P2|Participant Flow|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598415|NCT00526669|P1|Participant Flow|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
598416|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598417|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598465|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598466|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598418|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598419|NCT00526669|O1|Outcome|Overall Study Arm|
598420|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598421|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598422|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598423|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598424|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598425|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598426|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598427|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598428|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598429|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598430|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598431|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598432|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598467|NCT00526630|O3|Outcome|Baseline|Baseline gait composite scores
598468|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598569|NCT00526123|B1|Baseline|Symmetric Tip|symmetric tip hemodialysis catheter
598433|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598434|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598435|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598436|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598437|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598438|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598439|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598440|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598441|NCT00526669|O1|Outcome|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
598442|NCT00526669|E1|Reported Event|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
598443|NCT00526630|B1|Baseline|All Participants|Participants were randomized to receive both MPD and placebo.
598444|NCT00526630|P2|Participant Flow|Placebo Then MPD|First group treated with placebo then MPD
598445|NCT00526630|P1|Participant Flow|MPD Then Placebo|First group treated with MPD then placebo
598446|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
598447|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598448|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598449|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
598450|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598451|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598452|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
598453|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598454|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598455|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
598456|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598457|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598458|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
598459|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598460|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598461|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
598462|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
598463|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598469|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
598470|NCT00526630|E2|Reported Event|2. Placebo|"Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.~Placebo: Participants will be given placebo instead of active MPD."
598471|NCT00526630|E1|Reported Event|1. MPD|"Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.~Methylphenidate (MPD): Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day."
598472|NCT00526474|B3|Baseline|Total|Total of all reporting groups
598473|NCT00526474|B2|Baseline|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598474|NCT00526474|B1|Baseline|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598475|NCT00526474|P2|Participant Flow|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598476|NCT00526474|P1|Participant Flow|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598477|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598478|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598479|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598480|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598481|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598482|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598483|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598484|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598485|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598486|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598487|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598488|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598489|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598490|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598491|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598492|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598493|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598494|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598495|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598496|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598497|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598498|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598563|NCT00526162|P1|Participant Flow|1|
598564|NCT00526162|O1|Outcome|1|
598565|NCT00526162|O1|Outcome|1|
598566|NCT00526162|O1|Outcome|1|
598499|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598500|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598501|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598502|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598503|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598504|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598505|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598506|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598507|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598508|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598509|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598510|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598511|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598512|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598513|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598514|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598515|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598516|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598517|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598518|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598519|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598520|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598521|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598522|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598523|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598524|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598525|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598526|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598527|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598528|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598567|NCT00526123|B3|Baseline|Total|Total of all reporting groups
598568|NCT00526123|B2|Baseline|Split-tip|split-tip hemodialysis catheter
598529|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598530|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598531|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598532|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598533|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598534|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598535|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598536|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598537|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598538|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598539|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598540|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598541|NCT00526474|E2|Reported Event|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598542|NCT00526474|E1|Reported Event|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
598543|NCT00526331|B1|Baseline|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
598544|NCT00526331|P1|Participant Flow|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
598545|NCT00526331|O1|Outcome|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
598546|NCT00526331|E1|Reported Event|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
598547|NCT00526292|B1|Baseline|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
598548|NCT00526292|P1|Participant Flow|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
598549|NCT00526292|O1|Outcome|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
598550|NCT00526292|E1|Reported Event|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
598551|NCT00526227|B1|Baseline|1|
598552|NCT00526227|P1|Participant Flow|1|
598553|NCT00526227|O1|Outcome|1|
598554|NCT00526227|O1|Outcome|1|
598555|NCT00526227|O1|Outcome|1|
598556|NCT00526188|B1|Baseline|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
598557|NCT00526188|P1|Participant Flow|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
598558|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
598559|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
598560|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
598561|NCT00526188|E1|Reported Event|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
598562|NCT00526162|B1|Baseline|1|
598570|NCT00526123|P2|Participant Flow|Split-tip|split-tip hemodialysis catheter
598571|NCT00526123|P1|Participant Flow|Symmetric Tip|symmetric tip hemodialysis catheter
598572|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598573|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598574|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598575|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598576|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598577|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598578|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598579|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598580|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598581|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598582|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598583|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598584|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598585|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598586|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
598587|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
598588|NCT00526123|E2|Reported Event|Split-tip|split-tip hemodialysis catheter
598589|NCT00526123|E1|Reported Event|Symmetric Tip|symmetric tip hemodialysis catheter
598590|NCT00526110|B3|Baseline|Total|Total of all reporting groups
598591|NCT00526110|B2|Baseline|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598592|NCT00526110|B1|Baseline|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598593|NCT00526110|P2|Participant Flow|Phase II: Docetaxel MTD 50 mg/m^2|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598594|NCT00526110|P1|Participant Flow|Phase I: Dose Escalation|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598595|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598596|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598597|NCT00526110|O1|Outcome|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598598|NCT00526110|E2|Reported Event|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598599|NCT00526110|E1|Reported Event|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
598600|NCT00526097|B3|Baseline|Total|Total of all reporting groups
598601|NCT00526097|B2|Baseline|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598602|NCT00526097|B1|Baseline|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598603|NCT00526097|P2|Participant Flow|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598604|NCT00526097|P1|Participant Flow|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598605|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598606|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598607|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598608|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598609|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598610|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598611|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598612|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598613|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598614|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598615|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598616|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598617|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598618|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598619|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598620|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598621|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598622|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598623|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598624|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598625|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598626|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598627|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598628|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598629|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598630|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598631|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598632|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598633|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598634|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598635|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598636|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598637|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598638|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598639|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598640|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598641|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598642|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598643|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598644|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598645|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598646|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598647|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598648|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598649|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598650|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598651|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598652|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598653|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598654|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598655|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598656|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598657|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598658|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598659|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598660|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598661|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598662|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598663|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598664|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598665|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598666|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598667|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598668|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598669|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598670|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598671|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598672|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598673|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598674|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598675|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598676|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598677|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598678|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598679|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598680|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598681|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598682|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598683|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598684|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598685|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598686|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598687|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598688|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598689|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598690|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598691|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598692|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598693|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598694|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598695|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598696|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598697|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598698|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598699|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598700|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598701|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598702|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598703|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598704|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598705|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598706|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598707|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598708|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598709|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598710|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598711|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598712|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598713|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598714|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598715|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598716|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598717|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598718|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598719|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598720|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598721|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598722|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598723|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598724|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598725|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598726|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598727|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598728|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598729|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598730|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598731|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598732|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598733|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598734|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598735|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598736|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598737|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598738|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598739|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598740|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598741|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598742|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598743|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598744|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598745|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598746|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598747|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598748|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598749|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598750|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598751|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598752|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598753|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598754|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598755|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598756|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598757|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598758|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598759|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598760|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598761|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598762|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598763|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598764|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598765|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598766|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598767|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598768|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598769|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598770|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598771|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598772|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598773|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598774|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598775|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598776|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598777|NCT00526097|E2|Reported Event|Bisacodyl|Two bisacodyl 5 mg tablets once daily
598778|NCT00526097|E1|Reported Event|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
598779|NCT00526058|B3|Baseline|Total|Total of all reporting groups
598780|NCT00526058|B2|Baseline|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
598781|NCT00526058|B1|Baseline|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
598782|NCT00526058|P2|Participant Flow|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
598783|NCT00526058|P1|Participant Flow|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
598784|NCT00526058|O2|Outcome|Futura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
598785|NCT00526058|O1|Outcome|Secura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
598786|NCT00526058|E2|Reported Event|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
598787|NCT00526058|E1|Reported Event|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
598788|NCT00525915|B3|Baseline|Total|Total of all reporting groups
598789|NCT00525915|B2|Baseline|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
598790|NCT00525915|B1|Baseline|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
598791|NCT00525915|P2|Participant Flow|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
598792|NCT00525915|P1|Participant Flow|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
598793|NCT00525915|O2|Outcome|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
598794|NCT00525915|O1|Outcome|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
598795|NCT00525915|E2|Reported Event|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
598796|NCT00525915|E1|Reported Event|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
598797|NCT00525902|B1|Baseline|Adalimumab|
598798|NCT00525902|P1|Participant Flow|Adalimumab|
598799|NCT00525902|O1|Outcome|Adalimumab|
598800|NCT00525902|O1|Outcome|Adalimumab|
598801|NCT00525902|E1|Reported Event|Adalimumab|
598802|NCT00525876|B3|Baseline|Total|Total of all reporting groups
598803|NCT00525876|B2|Baseline|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
598804|NCT00525876|B1|Baseline|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
598805|NCT00525876|P2|Participant Flow|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
598806|NCT00525876|P1|Participant Flow|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
598807|NCT00525876|O2|Outcome|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
598808|NCT00525876|O1|Outcome|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
598809|NCT00525876|E2|Reported Event|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
598810|NCT00525876|E1|Reported Event|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
598811|NCT00525837|B1|Baseline|Varenicline|
598812|NCT00525837|P1|Participant Flow|Varenicline|
598813|NCT00525837|O1|Outcome|Varenicline|
598814|NCT00525837|E1|Reported Event|Varenicline|
598815|NCT00525824|B5|Baseline|Total|Total of all reporting groups
598816|NCT00525824|B4|Baseline|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598817|NCT00525824|B3|Baseline|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598818|NCT00525824|B2|Baseline|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598819|NCT00525824|B1|Baseline|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598820|NCT00525824|P4|Participant Flow|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598821|NCT00525824|P3|Participant Flow|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598822|NCT00525824|P2|Participant Flow|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598823|NCT00525824|P1|Participant Flow|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598824|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598825|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598826|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598827|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598828|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598829|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598830|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598831|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598832|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598833|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598834|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598835|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598836|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598837|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598838|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598839|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598840|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598841|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598842|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598843|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598844|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598845|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598846|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598847|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598848|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598849|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598850|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598851|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598852|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598853|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598854|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598855|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598856|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598857|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598858|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598859|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598860|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598861|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598862|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598863|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598864|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598865|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598866|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598867|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598868|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598869|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598870|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598871|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598872|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
598873|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
598874|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
598875|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
598876|NCT00525824|E8|Reported Event|Simva 80 mg + Eze 10 mg|Simvastatin 80 mg + Ezetimibe 10 mg
598877|NCT00525824|E7|Reported Event|Simva 40 mg + Eze 10 mg|Simvastatin 40 mg + Ezetimibe 10 mg
598878|NCT00525824|E6|Reported Event|Rosu 20 mg + Eze 10 mg|Rosuvastatin 20 mg + Ezetimibe 10 mg
598879|NCT00525824|E5|Reported Event|Rosu 10 mg + Eze 10 mg|Rosuvastatin 10 mg + Ezetimibe 10 mg
598880|NCT00525824|E4|Reported Event|Simvastatin 80 mg|Simvastatin 80 mg Monotherapy arm
598881|NCT00525824|E3|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg Monotherapy arm
598882|NCT00525824|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg Monotherapy arm
598883|NCT00525824|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg Monotherapy arm
598884|NCT00525798|B3|Baseline|Total|Total of all reporting groups
598885|NCT00525798|B2|Baseline|Placebo|1 tablet of placebo daily
598886|NCT00525798|B1|Baseline|SMC021|1 tablet of 0,80 mg SMC021 daily
598887|NCT00525798|P2|Participant Flow|Placebo|1 tablet of placebo daily
598888|NCT00525798|P1|Participant Flow|SMC021|1 tablet of 0,80 mg SMC021 daily
598889|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
598890|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
598891|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
598892|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
598893|NCT00525798|E2|Reported Event|Placebo|1 tablet of placebo daily
598894|NCT00525798|E1|Reported Event|SMC021|1 tablet of 0,80 mg SMC021 daily
598895|NCT00525733|B3|Baseline|Total|Total of all reporting groups
598896|NCT00525733|B2|Baseline|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
598897|NCT00525733|B1|Baseline|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
598898|NCT00525733|P2|Participant Flow|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
598899|NCT00525733|P1|Participant Flow|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
598900|NCT00525733|O2|Outcome|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
598901|NCT00525733|O1|Outcome|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
598902|NCT00525733|E2|Reported Event|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
598903|NCT00525733|E1|Reported Event|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
598904|NCT00525629|B1|Baseline|All Patients|All patients received both interventions and are included in this group analysis
598905|NCT00525629|P2|Participant Flow|Control Diet First, Then Walnut di|patients were asked to consume an isocaloric Diet with no Nuts
598906|NCT00525629|P1|Participant Flow|Walnut Diet First, Then Control Diet|patients were asked to consume 48g of walnuts per day
598907|NCT00525629|O2|Outcome|Control Diet|"Isocaloric Diet with No Walnuts~Control: Control Diet with No Walnuts"
598908|NCT00525629|O1|Outcome|Walnut Diet|"48 Grams of Walnuts Daily~Walnuts: 48 Grams of Walnuts Daily"
598909|NCT00525629|E2|Reported Event|Control Diet|Isocaloric Diet with no Nuts.
598910|NCT00525629|E1|Reported Event|Walnut Diet|48g of walnuts per day
598911|NCT00525603|B1|Baseline|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
598912|NCT00525603|P1|Participant Flow|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
598913|NCT00525603|O1|Outcome|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
598914|NCT00525603|E1|Reported Event|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
598915|NCT00525525|B3|Baseline|Total|Total of all reporting groups
598916|NCT00525525|B2|Baseline|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
598917|NCT00525525|B1|Baseline|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
598918|NCT00525525|P2|Participant Flow|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
598919|NCT00525525|P1|Participant Flow|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
598920|NCT00525525|O1|Outcome|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
598921|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
598922|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
598979|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598923|NCT00525525|E2|Reported Event|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
598924|NCT00525525|E1|Reported Event|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
598925|NCT00525512|B3|Baseline|Total|Total of all reporting groups
598926|NCT00525512|B2|Baseline|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598927|NCT00525512|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
598928|NCT00525512|P4|Participant Flow|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598929|NCT00525512|P3|Participant Flow|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598930|NCT00525512|P2|Participant Flow|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598931|NCT00525512|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
598932|NCT00525512|O4|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598933|NCT00525512|O3|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598934|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598935|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598936|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598937|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598938|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598939|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598940|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598941|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598942|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598943|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598944|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598945|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598946|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598947|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598948|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
598949|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
598950|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598951|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598952|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598953|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598954|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598955|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598956|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598957|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598958|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598959|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598960|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598961|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598962|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598963|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598964|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598965|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598966|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598967|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598968|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598969|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598970|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598971|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598972|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598973|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598974|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598975|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598976|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598977|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598978|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
608020|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
598980|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598981|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598982|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598983|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598984|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598985|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598986|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598987|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598988|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598989|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598990|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598991|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598992|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598993|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598994|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598995|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598996|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598997|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
598998|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
598999|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599000|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599001|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599002|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599003|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599004|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599005|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599006|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599007|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599008|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599009|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599010|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599011|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599012|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599013|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599014|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599015|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599016|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599017|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599018|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599019|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599020|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599021|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599022|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599023|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599024|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599025|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599026|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599027|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599028|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599029|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599030|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599031|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599032|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599033|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599034|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599035|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599036|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599037|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599038|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599039|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599040|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
608021|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
599041|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599042|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599043|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599044|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599045|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599046|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599047|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599048|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599049|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599050|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599051|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599052|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599053|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599054|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599055|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599056|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599057|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599058|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599059|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599060|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599061|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599062|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599063|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
599064|NCT00525512|E4|Reported Event|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
599065|NCT00525512|E3|Reported Event|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
599066|NCT00525512|E2|Reported Event|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
599067|NCT00525512|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
599068|NCT00525499|B5|Baseline|Total|Total of all reporting groups
599069|NCT00525499|B4|Baseline|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599070|NCT00525499|B3|Baseline|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599071|NCT00525499|B2|Baseline|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599072|NCT00525499|B1|Baseline|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
599073|NCT00525499|P4|Participant Flow|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599074|NCT00525499|P3|Participant Flow|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599075|NCT00525499|P2|Participant Flow|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599076|NCT00525499|P1|Participant Flow|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
599077|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599078|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599079|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599080|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
599081|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599082|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599083|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599084|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
599085|NCT00525499|E4|Reported Event|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599086|NCT00525499|E3|Reported Event|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599087|NCT00525499|E2|Reported Event|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
599088|NCT00525499|E1|Reported Event|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
599089|NCT00525421|B3|Baseline|Total|Total of all reporting groups
599090|NCT00525421|B2|Baseline|Placebo|Placebo : identical placebo tablets three times per day for 12 days
599091|NCT00525421|B1|Baseline|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
599092|NCT00525421|P2|Participant Flow|Placebo|Placebo : identical placebo tablets three times per day for 12 days
599093|NCT00525421|P1|Participant Flow|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
599094|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
599095|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
599096|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
599097|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
608022|NCT00502775|O1|Outcome|Placebo|
599098|NCT00525421|E2|Reported Event|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
599099|NCT00525421|E1|Reported Event|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
599100|NCT00525265|B3|Baseline|Total|Total of all reporting groups
599101|NCT00525265|B2|Baseline|OPC-41061 15 mg|OPC-41061 15 mg/day
599102|NCT00525265|B1|Baseline|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
599103|NCT00525265|P2|Participant Flow|OPC-41061 15 mg|OPC-41061 1.5 mg/day
599104|NCT00525265|P1|Participant Flow|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
599105|NCT00525265|O2|Outcome|OPC-41061 15 mg|OPC-41061 15 mg/day
599106|NCT00525265|O1|Outcome|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
599107|NCT00525265|E2|Reported Event|OPC-41061 15 mg|OPC-41061 15 mg/day
599108|NCT00525265|E1|Reported Event|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
599109|NCT00525174|B3|Baseline|Total|Total of all reporting groups
599110|NCT00525174|B2|Baseline|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
599111|NCT00525174|B1|Baseline|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
599112|NCT00525174|P2|Participant Flow|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
599113|NCT00525174|P1|Participant Flow|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
599114|NCT00525174|O2|Outcome|Patching|
599115|NCT00525174|O1|Outcome|Bangerter|
599116|NCT00525174|O2|Outcome|Patching|
599117|NCT00525174|O1|Outcome|Bangerter|
599118|NCT00525174|O2|Outcome|Patching|
599119|NCT00525174|O1|Outcome|Bangerter|
599120|NCT00525174|O2|Outcome|Patching|
599121|NCT00525174|O1|Outcome|Bangerter|
599122|NCT00525174|O2|Outcome|Patching|
599123|NCT00525174|O1|Outcome|Bangerter|
599124|NCT00525174|O2|Outcome|Patching|
599125|NCT00525174|O1|Outcome|Bangerter|
599126|NCT00525174|O2|Outcome|Patching|
599127|NCT00525174|O1|Outcome|Bangerter|
599128|NCT00525174|O2|Outcome|Patching|
599129|NCT00525174|O1|Outcome|Bangerter|
599130|NCT00525174|O2|Outcome|Patching|
599131|NCT00525174|O1|Outcome|Bangerter|
599132|NCT00525174|O2|Outcome|Patching|
599133|NCT00525174|O1|Outcome|Bangerter|
599134|NCT00525174|O2|Outcome|Patching|
599135|NCT00525174|O1|Outcome|Bangerter|
599136|NCT00525174|O2|Outcome|Patching|
599137|NCT00525174|O1|Outcome|Bangerter|
599138|NCT00525174|O2|Outcome|Patching|
599139|NCT00525174|O1|Outcome|Bangerter|
599140|NCT00525174|O2|Outcome|Patching|
599141|NCT00525174|O1|Outcome|Bangerter|
599142|NCT00525174|O2|Outcome|Patching|
599143|NCT00525174|O1|Outcome|Bangerter|
599144|NCT00525174|O2|Outcome|Patching|
599145|NCT00525174|O1|Outcome|Bangerter|
599146|NCT00525174|O2|Outcome|Patching|
599147|NCT00525174|O1|Outcome|Bangerter|
599148|NCT00525174|O2|Outcome|Patching|
599149|NCT00525174|O1|Outcome|Bangerter|
599150|NCT00525174|O2|Outcome|Patching|
599151|NCT00525174|O1|Outcome|Bangerter|
599152|NCT00525174|O2|Outcome|Patching|
599153|NCT00525174|O1|Outcome|Bangerter|
599154|NCT00525174|O2|Outcome|Patching|
599155|NCT00525174|O1|Outcome|Bangerter|
599156|NCT00525174|O2|Outcome|Patching|
599157|NCT00525174|O1|Outcome|Bangerter|
599158|NCT00525174|E2|Reported Event|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
599159|NCT00525174|E1|Reported Event|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
599160|NCT00525161|B1|Baseline|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
599161|NCT00525161|P1|Participant Flow|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
599162|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
599163|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
599164|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
599165|NCT00525161|E1|Reported Event|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
599166|NCT00525148|B5|Baseline|Total|Total of all reporting groups
599167|NCT00525148|B4|Baseline|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
599168|NCT00525148|B3|Baseline|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
599169|NCT00525148|B2|Baseline|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
599170|NCT00525148|B1|Baseline|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
599586|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599171|NCT00525148|P4|Participant Flow|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
599172|NCT00525148|P3|Participant Flow|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
599173|NCT00525148|P2|Participant Flow|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
599174|NCT00525148|P1|Participant Flow|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
599175|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
599176|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
599177|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
599178|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
599179|NCT00525148|O3|Outcome|Afatinib 50 mg|Subjects receiving 50 mg of Afatinib daily.
599180|NCT00525148|O2|Outcome|Afatinib 40 mg|Subjects receiving 40 mg of Afatinib daily.
599181|NCT00525148|O1|Outcome|Afatinib 30 mg|Subjects receiving 30 mg of Afatinib daily.
599182|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
599183|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
599184|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
599185|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
599186|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
599187|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
599188|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
599189|NCT00525148|E2|Reported Event|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
599190|NCT00525148|E1|Reported Event|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
599191|NCT00525135|B1|Baseline|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599192|NCT00525135|P1|Participant Flow|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599193|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599194|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599195|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599196|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599197|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599198|NCT00525135|E1|Reported Event|Study Intervention|Patients receive valproic acid daily for 16 weeks.
599199|NCT00525031|B3|Baseline|Total|Total of all reporting groups
599200|NCT00525031|B2|Baseline|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
608023|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
599201|NCT00525031|B1|Baseline|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
599202|NCT00525031|P2|Participant Flow|Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI)|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
599203|NCT00525031|P1|Participant Flow|Temozolomide (TMZ)|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
599204|NCT00525031|O1|Outcome|Overall Study|Arm A: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks. Arm B: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
599205|NCT00525031|O2|Outcome|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
599206|NCT00525031|O1|Outcome|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
599207|NCT00525031|E2|Reported Event|TMZ + PGI|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
599208|NCT00525031|E1|Reported Event|TMZ Alone|TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
599209|NCT00524940|B1|Baseline|Study Group|All participants enrolled and received Fluzone® Vaccine
599210|NCT00524940|P1|Participant Flow|Study Group|All participants enrolled and received Fluzone® Vaccine
599211|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
599212|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
599213|NCT00524940|E1|Reported Event|Study Group|All participants enrolled and received Fluzone® Vaccine
599214|NCT00524771|B3|Baseline|Total|Total of all reporting groups
599215|NCT00524771|B2|Baseline|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
599216|NCT00524771|B1|Baseline|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
599217|NCT00524771|P2|Participant Flow|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
599218|NCT00524771|P1|Participant Flow|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
599219|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
599220|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
599221|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
599222|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
599223|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
599224|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
599225|NCT00524771|E2|Reported Event|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
599226|NCT00524771|E1|Reported Event|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
599227|NCT00524745|B5|Baseline|Total|Total of all reporting groups
599228|NCT00524745|B4|Baseline|Standard (0,2,6 Month) Schedule|
599229|NCT00524745|B3|Baseline|0,12,24 Month Schedule|
599230|NCT00524745|B2|Baseline|0,6,12 Month Schedule|
599231|NCT00524745|B1|Baseline|0,3,9 Month Schedule|
599232|NCT00524745|P4|Participant Flow|Standard (0,2,6 Month) Schedule|
599233|NCT00524745|P3|Participant Flow|0,12,24 Month Schedule|
599234|NCT00524745|P2|Participant Flow|0,6,12 Month Schedule|
599235|NCT00524745|P1|Participant Flow|0,3,9 Month Schedule|
599236|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
599237|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
599238|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
599239|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
599240|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
599241|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
599242|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
599243|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
599244|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
599245|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
599246|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
599247|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
599248|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
599249|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
599250|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
599251|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
599252|NCT00524745|E4|Reported Event|Standard (0,2,6 Month) Schedule|
599253|NCT00524745|E3|Reported Event|0,12,24 Month Schedule|
599254|NCT00524745|E2|Reported Event|0,6,12 Month Schedule|
599255|NCT00524745|E1|Reported Event|0,3,9 Month Schedule|
599256|NCT00524680|B5|Baseline|Total|Total of all reporting groups
599257|NCT00524680|B4|Baseline|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599258|NCT00524680|B3|Baseline|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599259|NCT00524680|B2|Baseline|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599260|NCT00524680|B1|Baseline|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
599261|NCT00524680|P4|Participant Flow|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599587|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599262|NCT00524680|P3|Participant Flow|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599263|NCT00524680|P2|Participant Flow|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599264|NCT00524680|P1|Participant Flow|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
599265|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599266|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599267|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599268|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
599269|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599270|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599271|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599272|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
599273|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599274|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599275|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599276|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
599277|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599278|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599279|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599280|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
599281|NCT00524680|E4|Reported Event|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599282|NCT00524680|E3|Reported Event|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599283|NCT00524680|E2|Reported Event|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
599284|NCT00524680|E1|Reported Event|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
599285|NCT00524589|B1|Baseline|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
599286|NCT00524589|P1|Participant Flow|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
599287|NCT00524589|O1|Outcome|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
599288|NCT00524589|O1|Outcome|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
599289|NCT00524589|E1|Reported Event|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
599290|NCT00524576|B3|Baseline|Total|Total of all reporting groups
599291|NCT00524576|B2|Baseline|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599292|NCT00524576|B1|Baseline|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599293|NCT00524576|P2|Participant Flow|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599294|NCT00524576|P1|Participant Flow|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599295|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599296|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599297|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599298|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599299|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599300|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599301|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599302|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599303|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599304|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599305|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599306|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599307|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599308|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599309|NCT00524576|E2|Reported Event|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599310|NCT00524576|E1|Reported Event|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
599311|NCT00524537|B1|Baseline|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599312|NCT00524537|P1|Participant Flow|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599313|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599314|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599315|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599316|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599317|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599318|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599319|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599320|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599321|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599322|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599323|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599324|NCT00524537|E1|Reported Event|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
599325|NCT00524511|B3|Baseline|Total|Total of all reporting groups
599326|NCT00524511|B2|Baseline|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
599327|NCT00524511|B1|Baseline|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
599328|NCT00524511|P2|Participant Flow|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
599329|NCT00524511|P1|Participant Flow|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
599330|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
599331|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
599332|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
599333|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
599334|NCT00524511|E2|Reported Event|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
599335|NCT00524511|E1|Reported Event|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
599336|NCT00524485|B1|Baseline|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599337|NCT00524485|P1|Participant Flow|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599338|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599339|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599340|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599341|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599342|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599343|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599344|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599345|NCT00524485|E1|Reported Event|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
599346|NCT00524459|B1|Baseline|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599347|NCT00524459|P1|Participant Flow|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599348|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599391|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599349|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599350|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599351|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599352|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599353|NCT00524459|E1|Reported Event|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
599354|NCT00524420|B3|Baseline|Total|Total of all reporting groups
599355|NCT00524420|B2|Baseline|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
599356|NCT00524420|B1|Baseline|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
599357|NCT00524420|P2|Participant Flow|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
599358|NCT00524420|P1|Participant Flow|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
599359|NCT00524420|O2|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
599360|NCT00524420|O1|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
599361|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
599362|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
599363|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
599364|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
599365|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
599366|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
599367|NCT00524420|E2|Reported Event|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
599368|NCT00524420|E1|Reported Event|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
599369|NCT00524394|B1|Baseline|INFANTS|INFANTS 0 to 3 days of life >1500 G OR >32 WEEKS GA
599370|NCT00524394|P1|Participant Flow|Infants 0 to 3 Days of Life >1500 g or >32 Weeks GA|Infants born at >32 weeks of gestagional age or > 1500gm between 0 to 3 Days of Life
599371|NCT00524394|O1|Outcome|INFANTS 0 to 3 Days of Life (DOL) >1500 G OR >32 WEEKS GA|INFANTS 0 to 3 days of life born with >1500 gm OR >32 WEEKS gestational age
599372|NCT00524394|E1|Reported Event|Infants0-3 Days of Life >1500g or >32 Weeks GA|Infants born at 32 weeks of gestacional age or >1500 mg at 0-3 days of life .
599373|NCT00524368|B3|Baseline|Total|Total of all reporting groups
599374|NCT00524368|B2|Baseline|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599375|NCT00524368|B1|Baseline|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599376|NCT00524368|P2|Participant Flow|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599377|NCT00524368|P1|Participant Flow|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599378|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599379|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599380|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599381|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599382|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599383|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599384|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599385|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599386|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599387|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599388|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599389|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599390|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599392|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599393|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599394|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599395|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599396|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599397|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599398|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599399|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599400|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599401|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599402|NCT00524368|E2|Reported Event|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
599403|NCT00524368|E1|Reported Event|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
599404|NCT00524342|B1|Baseline|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
599405|NCT00524342|P1|Participant Flow|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
599406|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
599407|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
599408|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
599409|NCT00524342|E1|Reported Event|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
599410|NCT00524316|B1|Baseline|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599411|NCT00524316|P1|Participant Flow|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599412|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599413|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599414|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599415|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599416|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599417|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599418|NCT00524316|E1|Reported Event|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
599419|NCT00524303|B4|Baseline|Total|Total of all reporting groups
599420|NCT00524303|B3|Baseline|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599588|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599421|NCT00524303|B2|Baseline|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599422|NCT00524303|B1|Baseline|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599423|NCT00524303|P3|Participant Flow|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599424|NCT00524303|P2|Participant Flow|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599425|NCT00524303|P1|Participant Flow|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599426|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599427|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599428|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599429|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599430|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599431|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599432|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599473|NCT00524225|E1|Reported Event|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
599474|NCT00524173|B3|Baseline|Total|Total of all reporting groups
599475|NCT00524173|B2|Baseline|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
599433|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599434|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599435|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599436|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams (mg)/kilogram (kg) on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter. Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599437|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599438|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599439|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599440|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599441|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599442|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599443|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599444|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599476|NCT00524173|B1|Baseline|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
599477|NCT00524173|P2|Participant Flow|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
599478|NCT00524173|P1|Participant Flow|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
599589|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599445|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599446|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599447|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599448|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599449|NCT00524303|E3|Reported Event|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
599450|NCT00524303|E2|Reported Event|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
599451|NCT00524303|E1|Reported Event|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
599452|NCT00524264|B3|Baseline|Total|Total of all reporting groups
599453|NCT00524264|B2|Baseline|Vehicle Solution|
599454|NCT00524264|B1|Baseline|Ketorolac Solution|
599455|NCT00524264|P2|Participant Flow|Vehicle Solution|
599456|NCT00524264|P1|Participant Flow|Ketorolac Solution|
599457|NCT00524264|O2|Outcome|Vehicle Solution|
599458|NCT00524264|O1|Outcome|Ketorolac Solution|
599459|NCT00524264|O2|Outcome|Vehicle Solution|
599460|NCT00524264|O1|Outcome|Ketorolac Solution|
599461|NCT00524264|O2|Outcome|Vehicle Solution|
599462|NCT00524264|O1|Outcome|Ketorolac Solution|
599463|NCT00524264|O2|Outcome|Vehicle Solution|
599464|NCT00524264|O1|Outcome|Ketorolac Solution|
599465|NCT00524264|E2|Reported Event|Vehicle Solution|
599466|NCT00524264|E1|Reported Event|Ketorolac Solution|
599467|NCT00524225|B1|Baseline|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
599468|NCT00524225|P1|Participant Flow|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
599469|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
599470|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
599471|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
599472|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
599582|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599479|NCT00524173|O2|Outcome|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
599480|NCT00524173|O1|Outcome|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
599481|NCT00524173|O2|Outcome|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
599482|NCT00524173|O1|Outcome|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
599483|NCT00524173|O2|Outcome|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
599484|NCT00524173|O1|Outcome|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
599485|NCT00524173|O2|Outcome|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
599486|NCT00524173|O1|Outcome|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
599487|NCT00524173|E2|Reported Event|Tenofovir & Emtricitabine|"Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks~Tenofovir & Emtricitabine"
599488|NCT00524173|E1|Reported Event|Tenofovir Only|"Tenofovir 300mg by mouth daily for 192 weeks~Tenofovir"
599489|NCT00524134|B1|Baseline|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
599490|NCT00524134|P1|Participant Flow|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
599491|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
599492|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
599493|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
599494|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
599495|NCT00524134|E1|Reported Event|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
599496|NCT00524121|B1|Baseline|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599497|NCT00524121|P1|Participant Flow|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599498|NCT00524121|O2|Outcome|EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
599499|NCT00524121|O1|Outcome|No EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
599500|NCT00524121|O2|Outcome|pEGFR>20 μg/ml|Cut at median of 20 pEGFR>20 μg/ml
599501|NCT00524121|O1|Outcome|pEGFR<=20 μg/ml|Cut at median of 20 pEGFR<=20 μg/ml
599502|NCT00524121|O2|Outcome|EGFR>120 μg/ml|Cut at median of 120 EGFR>120 μg/ml
599503|NCT00524121|O1|Outcome|EGFR<=120 μg/ml|Cut at median of 120 EGFR<=120 μg/ml
599504|NCT00524121|O3|Outcome|Never Smokers|
599505|NCT00524121|O2|Outcome|Former Smokers|
599506|NCT00524121|O1|Outcome|Current Smokers|
599507|NCT00524121|O2|Outcome|Erlotinib in Combination With Radiotherapy at Week 3|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599508|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy at Baseline|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599509|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599510|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599511|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599583|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599512|NCT00524121|E1|Reported Event|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
599513|NCT00524043|B4|Baseline|Total|Total of all reporting groups
599514|NCT00524043|B3|Baseline|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599515|NCT00524043|B2|Baseline|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599516|NCT00524043|B1|Baseline|Placebo|One oral placebo tablet daily for 6 weeks.
599517|NCT00524043|P3|Participant Flow|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599518|NCT00524043|P2|Participant Flow|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599519|NCT00524043|P1|Participant Flow|Placebo|One oral placebo tablet daily for 6 weeks.
599520|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599521|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599522|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
599523|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599524|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599525|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
599526|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599527|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599528|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
599529|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599530|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599531|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
599532|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599533|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599534|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
599535|NCT00524043|E3|Reported Event|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
599536|NCT00524043|E2|Reported Event|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
599537|NCT00524043|E1|Reported Event|Placebo|One oral placebo tablet daily for 6 weeks.
599538|NCT00524030|B3|Baseline|Total|Total of all reporting groups
599539|NCT00524030|B2|Baseline|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599540|NCT00524030|B1|Baseline|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599541|NCT00524030|P2|Participant Flow|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599542|NCT00524030|P1|Participant Flow|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599543|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599544|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599545|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599584|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599585|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599546|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599547|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599548|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599549|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599550|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599551|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599552|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599553|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599554|NCT00524030|O1|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599555|NCT00524030|E2|Reported Event|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
599556|NCT00524030|E1|Reported Event|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
599557|NCT00523991|B3|Baseline|Total|Total of all reporting groups
599558|NCT00523991|B2|Baseline|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599559|NCT00523991|B1|Baseline|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599560|NCT00523991|P2|Participant Flow|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599561|NCT00523991|P1|Participant Flow|Placebo|Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
599562|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599563|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599564|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599565|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599566|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599567|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599568|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599569|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599570|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599571|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599572|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599573|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599574|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599575|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599576|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599577|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599578|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599579|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599580|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599581|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
608024|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
599590|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599591|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599592|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599593|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599594|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599595|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599596|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599597|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599598|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599599|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599600|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599601|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599602|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599603|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599604|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599605|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599606|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599607|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599608|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599609|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599610|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599611|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599612|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599613|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599614|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599615|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599616|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599617|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599618|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599619|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599620|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599621|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599622|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599623|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599624|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599625|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599626|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599627|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599628|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599629|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599630|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599631|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599632|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599633|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599634|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599635|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599636|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599637|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599638|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599639|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599640|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599641|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599642|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599643|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599644|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599645|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599646|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599647|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599648|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599649|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599650|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599651|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599652|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599653|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599654|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
608025|NCT00502775|O1|Outcome|Placebo|
599655|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599656|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599657|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599658|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599659|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599660|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599661|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599662|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599663|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599664|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599665|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599666|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599667|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599668|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599669|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599670|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599671|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599672|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599673|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599674|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599675|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599676|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599677|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599678|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599679|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599680|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599681|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599682|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599683|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599684|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599685|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599686|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599687|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599688|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599689|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599690|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599691|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599692|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599693|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599694|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599695|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599696|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599697|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599698|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599699|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599700|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599701|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599702|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599703|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599704|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599705|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599706|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599707|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599708|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599709|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599710|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599711|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599712|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599713|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599714|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599715|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599716|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599717|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599718|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599719|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
608026|NCT00502775|E3|Reported Event|Fexofenadine 180 mg|
599720|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599721|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599722|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599723|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599724|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599725|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599726|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599727|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599728|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599729|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599730|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599731|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599732|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599733|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599734|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599735|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599736|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599737|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599738|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599739|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599740|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599741|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599742|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599743|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599744|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599745|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599746|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599747|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599748|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599749|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599750|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599751|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599752|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599753|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599754|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599755|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599756|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599757|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599758|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599759|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599760|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599761|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599762|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599763|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599764|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599765|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599766|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599767|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599768|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599769|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599770|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599771|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599772|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599773|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599774|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599775|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599776|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599777|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599778|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599779|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599780|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599781|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599782|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599783|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599784|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
608027|NCT00502775|E2|Reported Event|Fluticasone Furoate 110mcg|
599785|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599786|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599787|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599788|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599789|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599790|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599791|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599792|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599793|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599794|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599795|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599796|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599797|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599798|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599799|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599800|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599801|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599802|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599803|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599804|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599805|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599806|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599807|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599808|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599809|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599810|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599811|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599812|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599813|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599814|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599815|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599816|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599817|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599818|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599819|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599820|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599821|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599822|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599823|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599824|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599825|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599826|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599827|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599828|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599829|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599830|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599831|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599832|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599833|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599834|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599835|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599836|NCT00523991|E2|Reported Event|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
599837|NCT00523991|E1|Reported Event|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
599838|NCT00523978|B3|Baseline|Total|Total of all reporting groups
599839|NCT00523978|B2|Baseline|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
599840|NCT00523978|B1|Baseline|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
599841|NCT00523978|P2|Participant Flow|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
599842|NCT00523978|P1|Participant Flow|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
599843|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
608028|NCT00502775|E1|Reported Event|Placebo|
599844|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
599845|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
599846|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
599847|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
599848|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
599849|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
599850|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
599851|NCT00523978|E2|Reported Event|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
599852|NCT00523978|E1|Reported Event|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
599853|NCT00523939|B3|Baseline|Total|Total of all reporting groups
599854|NCT00523939|B2|Baseline|Leukemic|Subjects with Leukemic Meningitis
599855|NCT00523939|B1|Baseline|Lymphomatous|Subjects with Lymphomatous Meningitis
599856|NCT00523939|P2|Participant Flow|Leukemic|Subjects with Leukemic Meningitis
599857|NCT00523939|P1|Participant Flow|Lymphomatous|Subjects with Lymphomatous Meningitis
599858|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
599859|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
599860|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
599861|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
599862|NCT00523939|E1|Reported Event|All Subjects|Subjects with Lymphomatous or Leukemic Meningitis.
599863|NCT00523848|B1|Baseline|VDT: VELCADE, Doxil and Low-dose Thalidomide|
599864|NCT00523848|P1|Participant Flow|Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide|Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
599865|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
599866|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
599867|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
599868|NCT00523848|E1|Reported Event|VDT: VELCADE, Doxil and Low-dose Thalidomide|
599869|NCT00523809|B1|Baseline|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
599870|NCT00523809|P1|Participant Flow|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
599871|NCT00523809|O1|Outcome|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
599872|NCT00523809|E1|Reported Event|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
599873|NCT00523744|B1|Baseline|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
599874|NCT00523744|P1|Participant Flow|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
599875|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
599876|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
599964|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599877|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
599878|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
599879|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
599880|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
599881|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
599882|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
599883|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
599884|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
599885|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
599886|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
599887|NCT00523744|E3|Reported Event|Phase 3 - Amlodipine+Valsartan+HCTZ|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
599888|NCT00523744|E2|Reported Event|Phase 2 - Amlodipine+Valsartan|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
599889|NCT00523744|E1|Reported Event|Phase 1 - Amlodipine+Olmesartan|4 weeks treatment with amlodipine 10 mg plus olmesartan 20 mg taken orally once daily in the morning.
599890|NCT00523718|B3|Baseline|Total|Total of all reporting groups
599891|NCT00523718|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
599892|NCT00523718|B1|Baseline|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
599893|NCT00523718|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
599894|NCT00523718|P1|Participant Flow|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
599895|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
599896|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
599897|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
599898|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
599899|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
599900|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
599901|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
599902|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
599903|NCT00523718|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
600636|NCT00521144|B5|Baseline|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
599904|NCT00523718|E1|Reported Event|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
599905|NCT00523705|B3|Baseline|Total|Total of all reporting groups
599906|NCT00523705|B2|Baseline|Sugar Pill|Placebo tablets matched to drug.
599907|NCT00523705|B1|Baseline|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
599908|NCT00523705|P2|Participant Flow|Sugar Pill|Placebo tablets matched to drug.
599909|NCT00523705|P1|Participant Flow|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
599910|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
599911|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
599912|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
599913|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
599914|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
599915|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
599916|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
599917|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
599918|NCT00523705|E2|Reported Event|Sugar Pill|Placebo tablets matched to drug.
599919|NCT00523705|E1|Reported Event|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
599920|NCT00523640|B1|Baseline|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
599921|NCT00523640|P1|Participant Flow|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
599922|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
599923|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
599924|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
599925|NCT00523640|E1|Reported Event|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
599926|NCT00523614|B3|Baseline|Total|Total of all reporting groups
599927|NCT00523614|B2|Baseline|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
599928|NCT00523614|B1|Baseline|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
599929|NCT00523614|P2|Participant Flow|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
599930|NCT00523614|P1|Participant Flow|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
599931|NCT00523614|O2|Outcome|Controls|Women without a venous thromboembolism who are between 15 and 49 years old
599932|NCT00523614|O1|Outcome|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
599933|NCT00523614|E2|Reported Event|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
599934|NCT00523614|E1|Reported Event|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
599935|NCT00523549|B3|Baseline|Total|Total of all reporting groups
599936|NCT00523549|B2|Baseline|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599937|NCT00523549|B1|Baseline|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599965|NCT00523419|E1|Reported Event|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599966|NCT00523367|B1|Baseline|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
599938|NCT00523549|P2|Participant Flow|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599939|NCT00523549|P1|Participant Flow|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599940|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599941|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599942|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599943|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599944|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599945|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599946|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599947|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599996|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599948|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599949|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599950|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599951|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599952|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599953|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599954|NCT00523549|E2|Reported Event|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
599955|NCT00523549|E1|Reported Event|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
599956|NCT00523419|B1|Baseline|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599957|NCT00523419|P1|Participant Flow|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599958|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599959|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599960|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599961|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599962|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
599963|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
608029|NCT00502697|B3|Baseline|Total|Total of all reporting groups
599967|NCT00523367|P1|Participant Flow|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
599968|NCT00523367|O1|Outcome|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
599969|NCT00523367|E1|Reported Event|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
599970|NCT00523341|B3|Baseline|Total|Total of all reporting groups
599971|NCT00523341|B2|Baseline|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599972|NCT00523341|B1|Baseline|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599973|NCT00523341|P2|Participant Flow|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599974|NCT00523341|P1|Participant Flow|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599975|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599976|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599977|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599978|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599979|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599980|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599981|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599982|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599983|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599984|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599985|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599986|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599987|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599988|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599989|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599990|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599991|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599992|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599993|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599994|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599995|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
601181|NCT00519532|E1|Reported Event|Rotigotine|Rotigotine Transdermal Patch
599997|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
599998|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
599999|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600000|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600001|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600002|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600003|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600004|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600005|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600006|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600007|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600008|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600009|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600010|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600011|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600012|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600013|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600014|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600015|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600016|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600017|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600018|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600019|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600020|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600021|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600022|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600023|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600024|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600025|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
601182|NCT00519428|B4|Baseline|Total|Total of all reporting groups
600026|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600027|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600028|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600029|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600030|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600031|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600032|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600033|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600034|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600035|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600036|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600037|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600038|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600039|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600040|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600041|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600042|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600043|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600044|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600045|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600046|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600047|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600048|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600049|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600050|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600051|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600052|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600053|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600054|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600798|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600055|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600056|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600057|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600058|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600059|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600060|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600061|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600062|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600063|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600064|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600065|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600066|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600067|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600068|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600069|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
600070|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
600071|NCT00523341|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
600072|NCT00523341|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.
600073|NCT00523237|B1|Baseline|Raltegravir|400 mg twice daily
600074|NCT00523237|P1|Participant Flow|Raltegravir|400 mg twice daily
600075|NCT00523237|O1|Outcome|Enfuvirtide Switch to Raltegravir Arm|patients were switched from Enfuvirtide to Raltegravir
600076|NCT00523237|E1|Reported Event|Raltegravir|400 mg twice daily
600077|NCT00522951|B1|Baseline|Entire Study Population|includes all participants received treatment
600078|NCT00522951|P2|Participant Flow|Gadoteridol Then Gadobutrol|Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
600079|NCT00522951|P1|Participant Flow|Gadobutrol Then Gadoteridol|Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
600080|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600081|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600082|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600083|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600084|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600085|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600086|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600087|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600088|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600089|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600090|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600091|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600092|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600093|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600094|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600095|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600096|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600097|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600098|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600099|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600100|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
600101|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600102|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600103|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600104|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600105|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600106|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600107|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600108|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600109|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600110|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600111|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600112|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600113|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600114|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
600115|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
600116|NCT00522951|E2|Reported Event|ProHance Period|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
600799|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600117|NCT00522951|E1|Reported Event|Gadobutrol Period|Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
600118|NCT00522925|B4|Baseline|Total|Total of all reporting groups
600119|NCT00522925|B3|Baseline|3- PS433540 500mg|500mg once daily for 4 weeks
600120|NCT00522925|B2|Baseline|2- PS433540 200mg|200mg daily for 4 weeks
600121|NCT00522925|B1|Baseline|1- Placebo|Placebo
600122|NCT00522925|P3|Participant Flow|3- PS433540 500mg|500mg once daily for 4 weeks
600123|NCT00522925|P2|Participant Flow|2- PS433540 200mg|200mg daily for 4 weeks
600124|NCT00522925|P1|Participant Flow|1- Placebo|Placebo
600125|NCT00522925|O3|Outcome|3- PS433540 500mg|500mg once daily for 4 weeks
600126|NCT00522925|O2|Outcome|2- PS433540 200mg|200mg daily for 4 weeks
600127|NCT00522925|O1|Outcome|1- Placebo|Placebo
600128|NCT00522925|E3|Reported Event|3- PS433540 500mg|500mg once daily for 4 weeks
600129|NCT00522925|E2|Reported Event|2- PS433540 200mg|200mg daily for 4 weeks
600130|NCT00522925|E1|Reported Event|1- Placebo|Placebo
600131|NCT00522873|B3|Baseline|Total|Total of all reporting groups
600132|NCT00522873|B2|Baseline|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
600133|NCT00522873|B1|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
600134|NCT00522873|P2|Participant Flow|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
600135|NCT00522873|P1|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
600136|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
600137|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
600138|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
600139|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
600140|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
600141|NCT00522873|E2|Reported Event|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
600142|NCT00522873|E1|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
600143|NCT00522795|B1|Baseline|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
600144|NCT00522795|P1|Participant Flow|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
600145|NCT00522795|O1|Outcome|PPX, Cisplatin, Radiation|
600146|NCT00522795|E1|Reported Event|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
600147|NCT00522626|B1|Baseline|Observational|Opioid exposed pregnancies
600148|NCT00522626|P1|Participant Flow|Observational|Opioid exposed pregnancies
600149|NCT00522626|O1|Outcome|Trough Fetal Heart Rate|Opioid exposed pregnancies
600150|NCT00522626|E1|Reported Event|Observational|Opioid exposed pregnancies
600151|NCT00522548|B3|Baseline|Total|Total of all reporting groups
600152|NCT00522548|B2|Baseline|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600153|NCT00522548|B1|Baseline|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600154|NCT00522548|P2|Participant Flow|CellCept Comparator Group|Patients in this group will receive CellCept (mycophenolate mofetil) 250mg capsules administered as 1000mg (4 capsules) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (rabbit anti-thymocyte globulin) Prograf (tacrolimus) or its generic equivalent and corticosteroids.
600155|NCT00522548|P1|Participant Flow|Myfortic Comparator Group|Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) 180 mg tablets administered as 720mg (4 tablets) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (Rabbit antithymocyte globulin), Prograf (tacrolimus) or its generic equivalanet and corticosteroids.
600156|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600157|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600259|NCT00522379|B4|Baseline|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600158|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600159|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600160|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600161|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600162|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600163|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600164|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600165|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600166|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600167|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600168|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600169|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600170|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600171|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600172|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600173|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600174|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600175|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600176|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600177|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600178|NCT00522548|O2|Outcome|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600179|NCT00522548|O1|Outcome|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600260|NCT00522379|B3|Baseline|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600180|NCT00522548|E2|Reported Event|CellCept Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
600181|NCT00522548|E1|Reported Event|Myfortic Comparator Group|Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
600182|NCT00522457|B1|Baseline|Ertumaxomab|
600183|NCT00522457|P1|Participant Flow|Ertumaxomab|
600184|NCT00522457|O1|Outcome|Ertumaxomab|
600185|NCT00522457|O1|Outcome|Ertumaxomab|
600186|NCT00522457|O1|Outcome|Ertumaxomab|
600187|NCT00522457|E1|Reported Event|Ertumaxomab|
600188|NCT00522431|B1|Baseline|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
600189|NCT00522431|P1|Participant Flow|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
600190|NCT00522431|O1|Outcome|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
600191|NCT00522431|O1|Outcome|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
600192|NCT00522431|E1|Reported Event|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
600193|NCT00522418|B3|Baseline|Total|Total of all reporting groups
600194|NCT00522418|B2|Baseline|Best Medical Practice|Best Medical Practice Without VNS Therapy
600195|NCT00522418|B1|Baseline|VNS Therapy|VNS Therapy + Best Medical Practice
600196|NCT00522418|P2|Participant Flow|Best Medical Practice|Best Medical Practice Without VNS Therapy
600197|NCT00522418|P1|Participant Flow|VNS Therapy|VNS Therapy + Best Medical Practice
600198|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600199|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600200|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score < 40|Population with Baseline Adverse Event Profile Score < 40
600201|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score >= 40|Population with Baseline Adverse Event Profile Score >= 40
600202|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600203|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600204|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600205|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600206|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600207|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600208|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600209|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600210|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600211|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600212|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600213|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600214|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600215|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600216|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600217|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600218|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600219|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600220|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600221|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600222|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600223|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600224|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600225|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600226|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600227|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600228|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600229|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600230|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600231|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600232|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600233|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600234|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600235|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600236|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600237|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600238|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
600239|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
600240|NCT00522418|E2|Reported Event|Best Medical Practice|Best Medical Practice Without VNS Therapy
600241|NCT00522418|E1|Reported Event|VNS Therapy|VNS Therapy + Best Medical Practice
600242|NCT00522392|B3|Baseline|Total|Total of all reporting groups
600261|NCT00522379|B2|Baseline|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600243|NCT00522392|B2|Baseline|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
600244|NCT00522392|B1|Baseline|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
600245|NCT00522392|P2|Participant Flow|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
600246|NCT00522392|P1|Participant Flow|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
600247|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
600248|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
600249|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
600250|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
600251|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
600252|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
600253|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
600254|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
600255|NCT00522392|E2|Reported Event|Arm B (Vd Regimen)|Arm B (Vd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
600256|NCT00522392|E1|Reported Event|Arm A (VRd Regimen)|Arm A (VRd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
600257|NCT00522379|B6|Baseline|Total|Total of all reporting groups
600258|NCT00522379|B5|Baseline|Placebo|
600416|NCT00521989|O4|Outcome|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
600262|NCT00522379|B1|Baseline|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600263|NCT00522379|P5|Participant Flow|Placebo|
600264|NCT00522379|P4|Participant Flow|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600265|NCT00522379|P3|Participant Flow|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600266|NCT00522379|P2|Participant Flow|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600267|NCT00522379|P1|Participant Flow|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600268|NCT00522379|O5|Outcome|Placebo|
600269|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600270|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600271|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600272|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600273|NCT00522379|O5|Outcome|Placebo|
600274|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600275|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600276|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600277|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600278|NCT00522379|O5|Outcome|Placebo|
600279|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600280|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600281|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600282|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600283|NCT00522379|O5|Outcome|Placebo|
600284|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600285|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600286|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600287|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600288|NCT00522379|O5|Outcome|Placebo|
600289|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600290|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600291|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600292|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600293|NCT00522379|O5|Outcome|Placebo|
600294|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600295|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600296|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600297|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600298|NCT00522379|O5|Outcome|Placebo|
600299|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600300|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600301|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600302|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600303|NCT00522379|O5|Outcome|Placebo|
600304|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600305|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600306|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600307|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600308|NCT00522379|O5|Outcome|Placebo|
600309|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600310|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600311|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600312|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600313|NCT00522379|O5|Outcome|Placebo|
600314|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600315|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600316|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600317|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600318|NCT00522379|O5|Outcome|Placebo|
600319|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600320|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600321|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600322|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600323|NCT00522379|O5|Outcome|Placebo|
600324|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600325|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600326|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600327|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600328|NCT00522379|O5|Outcome|Placebo|
600329|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600330|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600331|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600332|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600333|NCT00522379|O5|Outcome|Placebo|
600334|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600335|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600336|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600337|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600338|NCT00522379|O5|Outcome|Placebo|
600339|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600340|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600341|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600342|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600343|NCT00522379|O5|Outcome|Placebo|
600344|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600345|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600346|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600347|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600348|NCT00522379|O5|Outcome|Placebo|
600349|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600350|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600351|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600352|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600353|NCT00522379|O5|Outcome|Placebo|
600354|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600355|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600356|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
601183|NCT00519428|B3|Baseline|Bupropion|bupropion XL monotherapy
600357|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600358|NCT00522379|O5|Outcome|Placebo|
600359|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600360|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600361|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600362|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600363|NCT00522379|E5|Reported Event|Placebo|
600364|NCT00522379|E4|Reported Event|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600365|NCT00522379|E3|Reported Event|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
600366|NCT00522379|E2|Reported Event|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600367|NCT00522379|E1|Reported Event|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
600368|NCT00522301|B1|Baseline|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
600369|NCT00522301|P1|Participant Flow|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
600370|NCT00522301|O1|Outcome|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
600371|NCT00522301|E1|Reported Event|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
600372|NCT00522275|B1|Baseline|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600373|NCT00522275|P1|Participant Flow|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600374|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600375|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600376|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600377|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600378|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600379|NCT00522275|E1|Reported Event|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
600380|NCT00522171|B3|Baseline|Total|Total of all reporting groups
600381|NCT00522171|B2|Baseline|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
600382|NCT00522171|B1|Baseline|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
600383|NCT00522171|P2|Participant Flow|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
600384|NCT00522171|P1|Participant Flow|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
600385|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
600386|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
600417|NCT00521989|O3|Outcome|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600800|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600387|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
600388|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
600389|NCT00522171|E2|Reported Event|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
600390|NCT00522171|E1|Reported Event|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
600391|NCT00522041|B3|Baseline|Total|Total of all reporting groups
600392|NCT00522041|B2|Baseline|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600393|NCT00522041|B1|Baseline|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600394|NCT00522041|P2|Participant Flow|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600395|NCT00522041|P1|Participant Flow|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600396|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600397|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600398|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600399|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600400|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600401|NCT00522041|O1|Outcome|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600402|NCT00522041|E2|Reported Event|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600403|NCT00522041|E1|Reported Event|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
600404|NCT00521989|B6|Baseline|Total|Total of all reporting groups
600405|NCT00521989|B5|Baseline|Placebo|"Placebo~Placebo: Placebo"
600406|NCT00521989|B4|Baseline|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
600407|NCT00521989|B3|Baseline|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600408|NCT00521989|B2|Baseline|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600409|NCT00521989|B1|Baseline|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600410|NCT00521989|P5|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
600411|NCT00521989|P4|Participant Flow|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
600412|NCT00521989|P3|Participant Flow|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600413|NCT00521989|P2|Participant Flow|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600414|NCT00521989|P1|Participant Flow|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600415|NCT00521989|O5|Outcome|Placebo|"Placebo~Placebo: Placebo"
601184|NCT00519428|B2|Baseline|Escitalopram|escitalopram monotherapy
600418|NCT00521989|O2|Outcome|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600419|NCT00521989|O1|Outcome|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
600420|NCT00521989|E5|Reported Event|CRx-102 (2.7/360 mg)|CRx-102 dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
600421|NCT00521989|E4|Reported Event|CRx-102 (2.7/180 mg)|CRx-102 dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
600422|NCT00521989|E3|Reported Event|CRx-102 (2.7/90 mg)|CRx-102 dose 1 (2.7 mg prednisolone + 90 mg dipyridamole)
600423|NCT00521989|E2|Reported Event|Prednisolone|Prednisolone 2.7 mg
600424|NCT00521989|E1|Reported Event|Placebo|Placebo
600425|NCT00521976|B1|Baseline|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
600426|NCT00521976|P1|Participant Flow|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
600427|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
600428|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
600429|NCT00521976|E1|Reported Event|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
600430|NCT00521924|B3|Baseline|Total|Total of all reporting groups
600431|NCT00521924|B2|Baseline|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
600432|NCT00521924|B1|Baseline|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
600433|NCT00521924|P2|Participant Flow|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
600434|NCT00521924|P1|Participant Flow|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
600435|NCT00521924|O2|Outcome|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
600436|NCT00521924|O1|Outcome|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
600437|NCT00521924|E2|Reported Event|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
600438|NCT00521924|E1|Reported Event|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
600439|NCT00521885|B3|Baseline|Total|Total of all reporting groups
600440|NCT00521885|B2|Baseline|Lovenox 40mg SubCutaneously Daily|"Subjects may be randomized to Lovenox 40mg SubCutaneously Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first~Lovenox: Lovenox 40mg SC Daily"
600441|NCT00521885|B1|Baseline|Arixtra (Fondaparinox) 2.5 mg Given SubCutaneously Daily|"Subjects may be randomized to Arixtra (Fondaparinox) 2.5 mg given SubCutaneously Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first~Arixtra: Arixtra 2.5mg Sc Daily"
600442|NCT00521885|P2|Participant Flow|Lovenox 40mg Subcutaneously (SC) Daily|"Subjects will be randomized using a random generated listing of numbers with arm assignments associated with each assigned number. Only the study pharmacist will have access to this randomization code. All other study team members will remain blinded to the treatment arm. In this arm subjects will be randomized to Lovenox 40mg Subcutaneously (SC) Daily starting on day 1 and continuing through day 14 or day of discharge, whichever comes first.~Lovenox: Lovenox 40mg SC Daily"
600443|NCT00521885|P1|Participant Flow|Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC) Daily|"In this arm subjects will be randomized to Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC) once a day starting on day 1 and continuing through day 14 or day of discharge, whichever comes first.~Arixtra: Arixtra 2.5mg Sc Daily"
600444|NCT00521885|O2|Outcome|Lovenox 40mg Subcutaneously (SC) Daily|"Lovenox 40mg Subcutaneously (SC) Daily~Lovenox: Lovenox 40mg SC Daily"
600445|NCT00521885|O1|Outcome|Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC)Once a|"Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day~Arixtra: Arixtra 2.5mg Sc Daily"
600446|NCT00521885|O2|Outcome|Lovenox 40mg Subcutaneously (SC) Daily|"Lovenox 40mg Subcutaneously (SC) Daily~Lovenox: Lovenox 40mg SC Daily"
600447|NCT00521885|O1|Outcome|Arixtra (Fondaparinox) 2.5 mg Given Subcutaneously (SC)Once a|"Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day~Arixtra: Arixtra 2.5mg Sc Daily"
600448|NCT00521885|E2|Reported Event|Lovenox 40mg SC Daily|"Lovenox 40mg Subcutaneously (SC) Daily~Lovenox: Lovenox 40mg SC Daily"
600449|NCT00521885|E1|Reported Event|Arixtra (Fondaparinox) 2.5 mg Given SC Daily|"Arixtra (Fondaparinox) 2.5 mg given Subcutaneously (SC)once a day~Arixtra: Arixtra 2.5mg Sc Daily"
600450|NCT00521599|B4|Baseline|Total|Total of all reporting groups
600451|NCT00521599|B3|Baseline|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
600452|NCT00521599|B2|Baseline|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
600453|NCT00521599|B1|Baseline|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
600454|NCT00521599|P3|Participant Flow|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
600455|NCT00521599|P2|Participant Flow|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
600456|NCT00521599|P1|Participant Flow|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
600457|NCT00521599|O3|Outcome|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
600458|NCT00521599|O2|Outcome|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
600459|NCT00521599|O1|Outcome|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
600460|NCT00521599|E4|Reported Event|Placebo|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
600461|NCT00521599|E3|Reported Event|MF DPI 1 x 200 Mcg BID|1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks
600462|NCT00521599|E2|Reported Event|MF DPI 2 x 100 mcg BID|2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
600463|NCT00521599|E1|Reported Event|OL 1 X 200 mcg BID|Open-label MF DPI 200 mcg BID
600464|NCT00521586|B3|Baseline|Total|Total of all reporting groups
600465|NCT00521586|B2|Baseline|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600466|NCT00521586|B1|Baseline|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600467|NCT00521586|P2|Participant Flow|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600468|NCT00521586|P1|Participant Flow|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600469|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600470|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600471|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600472|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600801|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600473|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600474|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600475|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600476|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600477|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600478|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600479|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600480|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600545|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600637|NCT00521144|B4|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 4|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600481|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600482|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600483|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600484|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600485|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600486|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600487|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600488|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600546|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600638|NCT00521144|B3|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 3|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600489|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600490|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600491|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600492|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600493|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600494|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600495|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600547|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600802|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600496|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600497|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600498|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
600499|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600500|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600501|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600502|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600511|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
601185|NCT00519428|B1|Baseline|Escitalopram + Bupropion|escitalopram plus bupropion XL
600503|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600504|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600505|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600506|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600507|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600508|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
600509|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600510|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600595|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600512|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
600513|NCT00521586|E12|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
600514|NCT00521586|E11|Reported Event|Placebo+TIV/13vPnC: 13vPnC (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
600515|NCT00521586|E10|Reported Event|Placebo+TIV/13vPnC: Years 1-4|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
600516|NCT00521586|E9|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
600517|NCT00521586|E8|Reported Event|Placebo+TIV/13vPnC: Dose 2 (Year 0)|Participants who received 0.5-mL dose of 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
600518|NCT00521586|E7|Reported Event|Placebo+TIV/13vPnC: Dose 1 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
600519|NCT00521586|E6|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
600520|NCT00521586|E5|Reported Event|13vPnC+TIV/Placebo: 13vPnC (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
600521|NCT00521586|E4|Reported Event|13vPnC+TIV/Placebo: Years 1-4|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
600522|NCT00521586|E3|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
600523|NCT00521586|E2|Reported Event|13vPnC+TIV/Placebo: Dose 2 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
600524|NCT00521586|E1|Reported Event|13vPnC+TIV/Placebo: Dose 1 (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
600525|NCT00521456|B3|Baseline|Total|Total of all reporting groups
600526|NCT00521456|B2|Baseline|Vehicle Solution|
600527|NCT00521456|B1|Baseline|Ketorolac Solution|
600528|NCT00521456|P2|Participant Flow|Vehicle Solution|
600529|NCT00521456|P1|Participant Flow|Ketorolac Solution|
600530|NCT00521456|O2|Outcome|Vehicle Solution|
600531|NCT00521456|O1|Outcome|Ketorolac Solution|
600532|NCT00521456|O2|Outcome|Vehicle Solution|
600533|NCT00521456|O1|Outcome|Ketorolac Solution|
600534|NCT00521456|O2|Outcome|Vehicle Solution|
600535|NCT00521456|O1|Outcome|Ketorolac Solution|
600536|NCT00521456|O2|Outcome|Vehicle Solution|
600537|NCT00521456|O1|Outcome|Ketorolac Solution|
600538|NCT00521456|E2|Reported Event|Vehicle Solution|
600539|NCT00521456|E1|Reported Event|Ketorolac Solution|
600540|NCT00521365|B1|Baseline|Quetiapine 600 mg|Quetiapine Extended release 600 mg per day either as monotherapy or combined therapy
600541|NCT00521365|P1|Participant Flow|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600542|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600543|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600544|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600548|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600549|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600550|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600551|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600552|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600553|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600554|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600555|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600556|NCT00521365|E1|Reported Event|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
600557|NCT00521352|B3|Baseline|Total|Total of all reporting groups
600558|NCT00521352|B2|Baseline|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
600559|NCT00521352|B1|Baseline|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
600560|NCT00521352|P2|Participant Flow|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
600561|NCT00521352|P1|Participant Flow|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
600562|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
600563|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
600564|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
600565|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
600596|NCT00521339|O2|Outcome|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
600566|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
600567|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
600568|NCT00521352|E2|Reported Event|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
600569|NCT00521352|E1|Reported Event|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
600570|NCT00521339|B1|Baseline|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600571|NCT00521339|P3|Participant Flow|Apremilast 20mg/30mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
600572|NCT00521339|P2|Participant Flow|Apremilast 20mg/20mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
600573|NCT00521339|P1|Participant Flow|Apremilast 20mg|Participants received 20mg Apremilast capsules by mouth (PO) twice a day (BID) on Days 1 through 85 during the Treatment Phase
600574|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
600575|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
600576|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
600577|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
600578|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
600579|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
600580|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
600581|NCT00521339|O1|Outcome|Apremilast 20/30mg BID|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
600582|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600583|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600584|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600585|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600586|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600587|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600588|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600589|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600590|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600591|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600592|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600593|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600594|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600635|NCT00521144|B6|Baseline|Total|Total of all reporting groups
600597|NCT00521339|O1|Outcome|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
600598|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600599|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600600|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600601|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600602|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600603|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600604|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600605|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600606|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600607|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600608|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600609|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600610|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600611|NCT00521339|O1|Outcome|Apremilast 20mg PO BID|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600612|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600613|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600614|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600615|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600616|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600617|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600618|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600619|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
600620|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
600621|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
600622|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
600623|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600624|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600625|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
600626|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
600627|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the treatment phase
600628|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
600629|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
600630|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600631|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the Treatment Phase
600632|NCT00521339|E3|Reported Event|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
600633|NCT00521339|E2|Reported Event|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
600634|NCT00521339|E1|Reported Event|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
600639|NCT00521144|B2|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 2|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600640|NCT00521144|B1|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600641|NCT00521144|P5|Participant Flow|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
600642|NCT00521144|P4|Participant Flow|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600643|NCT00521144|P3|Participant Flow|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600644|NCT00521144|P2|Participant Flow|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600645|NCT00521144|P1|Participant Flow|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600646|NCT00521144|O5|Outcome|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
600647|NCT00521144|O4|Outcome|Phase 1; Level 4: Obatoclax Mesylate + Topotecan|Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600648|NCT00521144|O3|Outcome|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600649|NCT00521144|O2|Outcome|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600650|NCT00521144|O1|Outcome|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600651|NCT00521144|E5|Reported Event|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
600652|NCT00521144|E4|Reported Event|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600653|NCT00521144|E3|Reported Event|Phase I; Level 3: Obatoclax Mesylate + Topotecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600654|NCT00521144|E2|Reported Event|Phase I; Level 2: Obatoclax Mesylate + Topotecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600655|NCT00521144|E1|Reported Event|Phase I; Level 1: Obatoclax Mesylate + Topotecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
600656|NCT00521079|B3|Baseline|Total|Total of all reporting groups
600657|NCT00521079|B2|Baseline|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
600658|NCT00521079|B1|Baseline|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
600659|NCT00521079|P2|Participant Flow|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
600660|NCT00521079|P1|Participant Flow|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
600661|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
600662|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
600663|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
600664|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
600665|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
600666|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
600667|NCT00521079|E2|Reported Event|Placebo|Subjects implanted with a functional Maestro System device that does NOT delivers therapy (Therapy OFF).
600668|NCT00521079|E1|Reported Event|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
600669|NCT00521053|B1|Baseline|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
600670|NCT00521053|P1|Participant Flow|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation. In the treatment phase, participants received a single IL injection of PV-10 into each of up to 20 study lesions on day 0 (i.e., one cycle). Treatment cycles could be repeated at weeks 8, 12 and 16 for new non-target lesions or existing target or non-target lesions not exhibiting complete response (i.e., complete disappearance). Participants were observed for 52 weeks. Radiologic assessments of visceral disease status were performed every 12 weeks throughout the study and patients were transitioned into survival follow-up if at any time the investigator identified clinical or radiologic evidence of distant progression. No other melanoma therapy was permitted during the study interval.
600671|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
600672|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
600673|NCT00521053|O1|Outcome|All Lesions Treated|
600674|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
600675|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
600676|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
600677|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
600678|NCT00521053|E1|Reported Event|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
600679|NCT00521014|B1|Baseline|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
600680|NCT00521014|P1|Participant Flow|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF
600681|NCT00521014|O1|Outcome|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
600682|NCT00521014|E1|Reported Event|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
600683|NCT00521001|B1|Baseline|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
600684|NCT00521001|P1|Participant Flow|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
600685|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
600686|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
600687|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
600688|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
600689|NCT00521001|E1|Reported Event|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
600690|NCT00520975|B3|Baseline|Total|Total of all reporting groups
600691|NCT00520975|B2|Baseline|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600692|NCT00520975|B1|Baseline|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600693|NCT00520975|P2|Participant Flow|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600751|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600752|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600753|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
601186|NCT00519428|P3|Participant Flow|Bupropion|bupropion monotherapy
600694|NCT00520975|P1|Participant Flow|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600695|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600696|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600697|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600698|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600699|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600700|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600701|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600702|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600703|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600754|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600704|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600705|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600706|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600707|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600708|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600709|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600710|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600711|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600712|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600713|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600755|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
609617|NCT00498628|B3|Baseline|Total|Total of all reporting groups
600714|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600715|NCT00520975|E2|Reported Event|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
600716|NCT00520975|E1|Reported Event|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
600717|NCT00520936|B9|Baseline|Total|Total of all reporting groups
600718|NCT00520936|B8|Baseline|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600719|NCT00520936|B7|Baseline|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600720|NCT00520936|B6|Baseline|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600721|NCT00520936|B5|Baseline|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600722|NCT00520936|B4|Baseline|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600723|NCT00520936|B3|Baseline|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600724|NCT00520936|B2|Baseline|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600725|NCT00520936|B1|Baseline|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
600726|NCT00520936|P8|Participant Flow|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600727|NCT00520936|P7|Participant Flow|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600728|NCT00520936|P6|Participant Flow|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600729|NCT00520936|P5|Participant Flow|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600730|NCT00520936|P4|Participant Flow|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600731|NCT00520936|P3|Participant Flow|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600732|NCT00520936|P2|Participant Flow|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600733|NCT00520936|P1|Participant Flow|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
600734|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600735|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600736|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600737|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600738|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600739|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600740|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600741|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
600742|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600743|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600744|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600745|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600746|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600747|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600748|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600749|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
600750|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
610510|NCT00495586|B1|Baseline|Placebo|Placebo pills t.i.d. for 8 days
600756|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
600757|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
600758|NCT00520936|E1|Reported Event|Pemetrexed|Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old)
600759|NCT00520845|B1|Baseline|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600760|NCT00520845|P1|Participant Flow|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600761|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600762|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600763|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600764|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600765|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600766|NCT00520845|E1|Reported Event|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
600767|NCT00520767|B1|Baseline|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
600768|NCT00520767|P1|Participant Flow|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
600769|NCT00520767|O1|Outcome|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
600770|NCT00520767|E1|Reported Event|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
600771|NCT00520741|B3|Baseline|Total|Total of all reporting groups
600772|NCT00520741|B2|Baseline|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600773|NCT00520741|B1|Baseline|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
601187|NCT00519428|P2|Participant Flow|Escitalopram|escitalopram monotherapy
600774|NCT00520741|P2|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600775|NCT00520741|P1|Participant Flow|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600776|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600777|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600778|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600779|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600780|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600781|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600782|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3 :1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
600783|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600784|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600785|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600786|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
600787|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600788|NCT00520741|E2|Reported Event|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600789|NCT00520741|E1|Reported Event|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
600790|NCT00520676|B3|Baseline|Total|Total of all reporting groups
600791|NCT00520676|B2|Baseline|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600792|NCT00520676|B1|Baseline|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600793|NCT00520676|P2|Participant Flow|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600794|NCT00520676|P1|Participant Flow|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600795|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600796|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600797|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600803|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600804|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600805|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600806|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600807|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600808|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600809|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600810|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600811|NCT00520676|E2|Reported Event|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600812|NCT00520676|E1|Reported Event|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
600813|NCT00520572|B7|Baseline|Total|Total of all reporting groups
600814|NCT00520572|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600815|NCT00520572|B5|Baseline|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600816|NCT00520572|B4|Baseline|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600817|NCT00520572|B3|Baseline|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600818|NCT00520572|B2|Baseline|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600819|NCT00520572|B1|Baseline|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600820|NCT00520572|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600821|NCT00520572|P5|Participant Flow|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600822|NCT00520572|P4|Participant Flow|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600823|NCT00520572|P3|Participant Flow|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600824|NCT00520572|P2|Participant Flow|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600825|NCT00520572|P1|Participant Flow|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600826|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600827|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600828|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600829|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600830|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600831|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600832|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600833|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600834|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600835|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600836|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600837|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600838|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600839|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600840|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600841|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600842|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600843|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600844|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600845|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600846|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600847|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600848|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600849|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600850|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600851|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600852|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600853|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600854|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600855|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600856|NCT00520572|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
600857|NCT00520572|E5|Reported Event|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
600858|NCT00520572|E4|Reported Event|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
600859|NCT00520572|E3|Reported Event|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
600860|NCT00520572|E2|Reported Event|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
600861|NCT00520572|E1|Reported Event|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
600862|NCT00520546|B1|Baseline|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
600863|NCT00520546|P1|Participant Flow|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
600864|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
600865|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
600866|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
600867|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
600868|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
600869|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
600870|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
600871|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
600872|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
600873|NCT00520546|O3|Outcome|PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)|PET images at 45 min p.i. (post injection) and 65 min p.i. were fused with transversal endorectal and QBody T2 weighed (T2w) MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
601188|NCT00519428|P1|Participant Flow|Escitalopram + Bupropion|escitalopram plus bupropion
600874|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2 weighed (T2w) spin echo (SE) sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
600875|NCT00520546|O1|Outcome|[18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
600876|NCT00520546|E1|Reported Event|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
600877|NCT00520494|B1|Baseline|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600878|NCT00520494|P1|Participant Flow|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600879|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600880|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600881|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600882|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600883|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600884|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600885|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600886|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600887|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600888|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600889|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600890|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600891|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600892|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600893|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600894|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600895|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600896|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600897|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
601189|NCT00519428|O3|Outcome|Bupropion|bupropion XL monotherapy
600898|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600899|NCT00520494|E1|Reported Event|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
600900|NCT00520468|B1|Baseline|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
600901|NCT00520468|P1|Participant Flow|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
600902|NCT00520468|O1|Outcome|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
600903|NCT00520468|E1|Reported Event|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
600904|NCT00520403|B1|Baseline|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
600905|NCT00520403|P1|Participant Flow|Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
600906|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
600907|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
600908|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
600909|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
600938|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600939|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600940|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600941|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
601190|NCT00519428|O2|Outcome|Escitalopram|escitalopram monotherapy
600910|NCT00520403|E1|Reported Event|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
600911|NCT00520351|B3|Baseline|Total|Total of all reporting groups
600912|NCT00520351|B2|Baseline|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
600913|NCT00520351|B1|Baseline|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
600914|NCT00520351|P2|Participant Flow|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
600915|NCT00520351|P1|Participant Flow|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
600916|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
600917|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
600918|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
600919|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
600920|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
600921|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
600922|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
600923|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
600924|NCT00520351|E2|Reported Event|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
600925|NCT00520351|E1|Reported Event|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
600926|NCT00520299|B4|Baseline|Total|Total of all reporting groups
600927|NCT00520299|B3|Baseline|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600928|NCT00520299|B2|Baseline|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600929|NCT00520299|B1|Baseline|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600930|NCT00520299|P3|Participant Flow|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600931|NCT00520299|P2|Participant Flow|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600932|NCT00520299|P1|Participant Flow|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600933|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600934|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600935|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600936|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600937|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600942|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600943|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600944|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600945|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600946|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600947|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600948|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600949|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600950|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600951|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600952|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600953|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600954|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
600955|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
600956|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
600957|NCT00520299|E3|Reported Event|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects who received 160 IU/m^2/week of ADI-PEG 20
600958|NCT00520299|E2|Reported Event|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects who received 80 IU/m^2/week of ADI-PEG 20
600959|NCT00520299|E1|Reported Event|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects who received 40 IU/m^2/week of ADI-PEG 20
600960|NCT00520286|B3|Baseline|Total|Total of all reporting groups
600961|NCT00520286|B2|Baseline|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
600962|NCT00520286|B1|Baseline|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
600963|NCT00520286|P2|Participant Flow|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
600964|NCT00520286|P1|Participant Flow|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
600965|NCT00520286|O2|Outcome|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
600966|NCT00520286|O1|Outcome|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
600967|NCT00520286|O2|Outcome|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
600968|NCT00520286|O1|Outcome|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
600969|NCT00520286|E2|Reported Event|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
600970|NCT00520286|E1|Reported Event|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
600971|NCT00520234|B3|Baseline|Total|Total of all reporting groups
600972|NCT00520234|B2|Baseline|Placebo|Normal Saline 100 cc IV daily
600973|NCT00520234|B1|Baseline|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
600974|NCT00520234|P2|Participant Flow|Placebo|Normal Saline 100 cc IV daily
600975|NCT00520234|P1|Participant Flow|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
600976|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
600977|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
600978|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
600979|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
600980|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
600981|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50mg IV daily
600982|NCT00520234|E2|Reported Event|Placebo|Normal Saline 100 cc IV daily
600983|NCT00520234|E1|Reported Event|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
600984|NCT00520130|B3|Baseline|Total|Total of all reporting groups
600985|NCT00520130|B2|Baseline|Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601032|NCT00520039|O2|Outcome|After OMM|"Result of tympanogram reading after OMM.~Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician."
611438|NCT00493285|E4|Reported Event|10^5 PLACEBO|
600986|NCT00520130|B1|Baseline|Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
600987|NCT00520130|P2|Participant Flow|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
600988|NCT00520130|P1|Participant Flow|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
600989|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
600990|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm Rituximab: 375 mg/m2 IV, day 1 for patients with cluster of differentiation 20 (CD20)-positive disease Allogenic stem cell transplant (ASCT):Allogenic stem cell transplant Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna:1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11 Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
600991|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
600992|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm Rituximab: 375 mg/m2 IV, day 1 for patients with cluster of differentiation 20 (CD20)-positive disease Allogenic stem cell transplant (ASCT):Allogenic stem cell transplant Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna:1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11 Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
601033|NCT00520039|O1|Outcome|Before OMM|"Result of tympanogram reading before OMM.~Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician."
611439|NCT00493285|E3|Reported Event|10^5 MEDI-534|
600993|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
600994|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm Rituximab: 375 mg/m2 IV, day 1 for patients with cluster of differentiation 20 (CD20)-positive disease Allogenic stem cell transplant (ASCT):Allogenic stem cell transplant Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna:1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11 Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
600995|NCT00520130|O2|Outcome|B - Cyclosporine (C) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
600996|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
600997|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
600998|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
600999|NCT00520130|O2|Outcome|B - Cyclosporine (C) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601034|NCT00520039|O2|Outcome|After OMM|"Result of tympanogram reading after OMM.~Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician."
601191|NCT00519428|O1|Outcome|Escitalopram + Bupropion|escitalopram plus bupropion XL
601000|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601001|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601002|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601003|NCT00520130|O2|Outcome|B - Cyclosporine (AC Arm)|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601004|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601005|NCT00520130|O2|Outcome|B - Cyclosporine (AC Arm)|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601006|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601035|NCT00520039|O1|Outcome|Before OMM|"Result of tympanogram reading before OMM.~Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician."
611440|NCT00493285|E2|Reported Event|10^4 PLACEBO|
601007|NCT00520130|O2|Outcome|B - Cyclosporine (AC Arm)|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601008|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601009|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601010|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601011|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601012|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601013|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601036|NCT00520039|O2|Outcome|Standard Care Only (SCO)|Subjects will receive standard care only for otitis media from their regular referring physician
601081|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601014|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
601015|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601016|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
601017|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601018|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601019|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601020|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601076|NCT00519779|B3|Baseline|Total|Total of all reporting groups
601077|NCT00519779|B2|Baseline|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601078|NCT00519779|B1|Baseline|Placebo|Placebo oral Omega-3 fish oil supplementation
601021|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601022|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601023|NCT00520130|O2|Outcome|B - Cyclosporine (AC) Arm|Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
601024|NCT00520130|O1|Outcome|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
601025|NCT00520130|E2|Reported Event|B - Cyclosporine (AC) Arm|"AC Arm~Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease~Cyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop.~Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant~Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d"
601026|NCT00520130|E1|Reported Event|A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm|"TMS Arm~Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease~Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant~Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3~TMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy"
601027|NCT00520039|B3|Baseline|Total|Total of all reporting groups
601028|NCT00520039|B2|Baseline|Standard Care Only|Subjects will receive standard care only for otitis media from their regular referring physician
601029|NCT00520039|B1|Baseline|Standard Care Plus OMM|Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate, at each of the first 3 study visits. Subjects will also receive standard care for otitis media from their referring physician.
601030|NCT00520039|P2|Participant Flow|Standard Care Only (SCO)|Subjects will receive standard care only for otitis media from their regular referring physician
601031|NCT00520039|P1|Participant Flow|Standard Care Plus OMM (SC+OMM)|"Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.~osteopathic manipulative medicine (OMM): At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol."
601082|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
611441|NCT00493285|E1|Reported Event|10^4 MEDI-534|
601037|NCT00520039|O1|Outcome|Standard Care Plus OMM (SC+OMM)|"Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.~Osteopathic manipulative medicine (OMM): At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol."
601038|NCT00520039|E2|Reported Event|Standard Care Only|"Subjects will receive standard care only for otitis media from their regular referring physician.~There were no Serious Adverse Events reported."
601039|NCT00520039|E1|Reported Event|Standard Care Plus OMM|"Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.~osteopathic manipulative medicine (OMM): At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.~There were no Serious Adverse Events reported."
601040|NCT00520013|B4|Baseline|Total|Total of all reporting groups
601041|NCT00520013|B3|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None~bevacizumab~paclitaxel~carboplatin"
601042|NCT00520013|B2|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.~bevacizumab~erlotinib~paclitaxel~carboplatin"
601043|NCT00520013|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.~bevacizumab~paclitaxel~carboplatin"
601044|NCT00520013|P3|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None"
601045|NCT00520013|P2|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
601046|NCT00520013|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
601047|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
601048|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
601049|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
601050|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
601051|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
601079|NCT00519779|P2|Participant Flow|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601080|NCT00519779|P1|Participant Flow|Placebo|Placebo oral Omega-3 fish oil supplementation
601052|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
601053|NCT00520013|E2|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
601054|NCT00520013|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
601055|NCT00519896|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
601056|NCT00519896|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
601057|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
601058|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
601059|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
601060|NCT00519896|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
601061|NCT00519831|B1|Baseline|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
601062|NCT00519831|P1|Participant Flow|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
601063|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
601064|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
601065|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
601066|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
601067|NCT00519831|E1|Reported Event|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
601068|NCT00519818|B1|Baseline|Cortef Then Chronocort|Hydrocortisone immediate release 3 times daily total dose 30mg for 7 days, then hydrocortisone modified release tablet 30mg once nightly for 28days
601069|NCT00519818|P1|Participant Flow|Cortef Then Chronocort|Hydrocortisone immediate release tablet treatment then Modified release hydrocortisone
601070|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
601071|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
601072|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
601073|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
601074|NCT00519818|E2|Reported Event|Cortef|Hydrocortisone immediate release tablet
601075|NCT00519818|E1|Reported Event|Chronocort|Hydrocortisone modified release tablet
601083|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601084|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
601085|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601086|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
601087|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601088|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
601089|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601090|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
601091|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601092|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
601093|NCT00519779|E2|Reported Event|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
601094|NCT00519779|E1|Reported Event|Placebo|Placebo oral Omega-3 fish oil supplementation
601095|NCT00519649|B1|Baseline|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601096|NCT00519649|P1|Participant Flow|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601097|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601098|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601099|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601100|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601101|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601102|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601103|NCT00519649|E1|Reported Event|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
601104|NCT00519636|B5|Baseline|Total|Total of all reporting groups
601105|NCT00519636|B4|Baseline|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
601106|NCT00519636|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601107|NCT00519636|B2|Baseline|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
601108|NCT00519636|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601109|NCT00519636|P4|Participant Flow|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
601110|NCT00519636|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601111|NCT00519636|P2|Participant Flow|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
601112|NCT00519636|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601113|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
601114|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601115|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601116|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
601117|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601118|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601119|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
601175|NCT00519532|B1|Baseline|Rotigotine|Rotigotine Transdermal Patch
601120|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601121|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601122|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
601123|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601124|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
601125|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601126|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
601127|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601128|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
601129|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601130|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
601131|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601132|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601133|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
601134|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
601135|NCT00519636|O2|Outcome|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
601136|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
601137|NCT00519636|E4|Reported Event|Placebo -FP|Subject who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
601138|NCT00519636|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
601139|NCT00519636|E2|Reported Event|Fluticasone Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
601140|NCT00519636|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
601141|NCT00519623|B1|Baseline|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
601142|NCT00519623|P1|Participant Flow|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
601143|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
601144|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
601145|NCT00519623|E1|Reported Event|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
601146|NCT00519584|B5|Baseline|Total|Total of all reporting groups
601147|NCT00519584|B4|Baseline|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601148|NCT00519584|B3|Baseline|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
601149|NCT00519584|B2|Baseline|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
601150|NCT00519584|B1|Baseline|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601176|NCT00519532|P1|Participant Flow|Rotigotine|Rotigotine Transdermal Patch
601151|NCT00519584|P4|Participant Flow|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601152|NCT00519584|P3|Participant Flow|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
601153|NCT00519584|P2|Participant Flow|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
601154|NCT00519584|P1|Participant Flow|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601155|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601156|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
601157|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
601158|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601159|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601160|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
601161|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
601162|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601163|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601164|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
601165|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
601166|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601167|NCT00519584|O4|Outcome|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601168|NCT00519584|O3|Outcome|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
601169|NCT00519584|O2|Outcome|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
601170|NCT00519584|O1|Outcome|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601171|NCT00519584|E4|Reported Event|Bupivacaine/Saline|"bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Bupivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601172|NCT00519584|E3|Reported Event|Bupivacaine/Dex|"bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.~dex: 8 mg (2 ml)~Bupivacaine: 30 ml 0.5%"
601173|NCT00519584|E2|Reported Event|Ropivacaine/Dex|"Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;~Ropivacaine: 30 ml 0.5%~dex: 8 mg (2 ml)"
601174|NCT00519584|E1|Reported Event|Ropivacaine/Saline|"Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block~Ropivacaine: 30 ml 0.5%~Saline: 0.9% saline; systemic and local"
601192|NCT00519428|O3|Outcome|Bupropion|"bupropion XL monotherapy~bupropion XL: 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted"
601193|NCT00519428|O2|Outcome|Escitalopram|"escitalopram monotherapy~escitalopram: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted"
601194|NCT00519428|O1|Outcome|Escitalopram + Bupropion|"escitalopram plus bupropion XL as dual treatment (i.e., this is not a SINGLE treatment arm; all patients assigned this arm received both medications)~escitalopram + bupropion: same dosing schedule as for monotherapy"
601195|NCT00519428|O3|Outcome|Bupropion|bupropion XL monotherapy
601196|NCT00519428|O2|Outcome|Escitalopram|escitalopram monotherapy
601197|NCT00519428|O1|Outcome|Escitalopram + Bupropion|escitalopram plus bupropion XL
601198|NCT00519428|O3|Outcome|Bupropion|bupropion XL monotherapy
601199|NCT00519428|O2|Outcome|Escitalopram|escitalopram monotherapy
601200|NCT00519428|O1|Outcome|Escitalopram + Bupropion|escitalopram plus bupropion XL
601201|NCT00519428|O3|Outcome|Bupropion|bupropion XL monotherapy
601202|NCT00519428|O2|Outcome|Escitalopram|escitalopram monotherapy
601203|NCT00519428|O1|Outcome|Escitalopram + Bupropion|escitalopram plus bupropion XL
601204|NCT00519428|E3|Reported Event|Bupropion|"bupropion XL monotherapy~bupropion XL: 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted"
601205|NCT00519428|E2|Reported Event|Escitalopram|"escitalopram monotherapy~escitalopram: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted"
601206|NCT00519428|E1|Reported Event|Escitalopram + Bupropion|"escitalopram plus bupropion XL~escitalopram + bupropion: same dosing schedule as for monotherapy"
601207|NCT00519376|B1|Baseline|GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq|Participants were administered single dose of four of the five following treatments: GW642444M (25, 50 and 100 µg), GW642444H (100 µg) or placebo. Each participant received doses of GW642444M in an ascending dose manner with GW642444H and placebo randomly interspersed as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601208|NCT00519376|P16|Participant Flow|Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601209|NCT00519376|P15|Participant Flow|Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601210|NCT00519376|P14|Participant Flow|Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, Placebo, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601211|NCT00519376|P13|Participant Flow|Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601212|NCT00519376|P12|Participant Flow|Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601213|NCT00519376|P11|Participant Flow|Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601214|NCT00519376|P10|Participant Flow|Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601215|NCT00519376|P9|Participant Flow|Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601216|NCT00519376|P8|Participant Flow|Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601217|NCT00519376|P7|Participant Flow|Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601218|NCT00519376|P6|Participant Flow|Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601249|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601684|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601219|NCT00519376|P5|Participant Flow|Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601220|NCT00519376|P4|Participant Flow|Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601221|NCT00519376|P3|Participant Flow|Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601222|NCT00519376|P2|Participant Flow|Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601223|NCT00519376|P1|Participant Flow|Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: Placebo (PB), GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg. Each participants received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601224|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601225|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601226|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601227|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601228|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601229|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601230|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601231|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601232|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601233|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601234|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601235|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601236|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601237|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601238|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601239|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601240|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601241|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601242|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601243|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601244|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601245|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601246|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601247|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601248|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601250|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601251|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601252|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601253|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601254|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601255|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601256|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601257|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601258|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601259|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601260|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601261|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601262|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601263|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601264|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601265|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601266|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601267|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601268|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601269|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601270|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601271|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601272|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601273|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601274|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601275|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601276|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601277|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601278|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601279|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601280|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601281|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601282|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601283|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601685|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601284|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601285|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601286|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601287|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601288|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601289|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601290|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601291|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601292|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601293|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601294|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601295|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601296|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601297|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601298|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601299|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601300|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601301|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601302|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601303|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601304|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601305|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601306|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601307|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601308|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601309|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601310|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601311|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601312|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601313|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601314|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601315|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601316|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601317|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
611442|NCT00493246|B9|Baseline|Total|Total of all reporting groups
601318|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601319|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601320|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601321|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601322|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601323|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601324|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601325|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601326|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601327|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601328|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601329|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601330|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601331|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601332|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601333|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601334|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601335|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601336|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601337|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601338|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601339|NCT00519376|E5|Reported Event|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601340|NCT00519376|E4|Reported Event|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601341|NCT00519376|E3|Reported Event|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601342|NCT00519376|E2|Reported Event|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601343|NCT00519376|E1|Reported Event|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
601344|NCT00519285|B3|Baseline|Total|Total of all reporting groups
601345|NCT00519285|B2|Baseline|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601346|NCT00519285|B1|Baseline|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601347|NCT00519285|P2|Participant Flow|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601348|NCT00519285|P1|Participant Flow|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601349|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601350|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601351|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601686|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601352|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601353|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601354|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601355|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601356|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601357|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601358|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601359|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601360|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601361|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601362|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601363|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601364|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601365|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601366|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601367|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601368|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601369|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601370|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601371|NCT00519285|E2|Reported Event|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601372|NCT00519285|E1|Reported Event|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
601373|NCT00519194|B1|Baseline|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
601374|NCT00519194|P1|Participant Flow|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure"
601375|NCT00519194|O1|Outcome|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
601376|NCT00519194|E1|Reported Event|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
601377|NCT00519090|B3|Baseline|Total|Total of all reporting groups
601378|NCT00519090|B2|Baseline|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
601379|NCT00519090|B1|Baseline|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
601380|NCT00519090|P2|Participant Flow|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
601381|NCT00519090|P1|Participant Flow|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
601382|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
601383|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
601384|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
601385|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
601386|NCT00519090|E2|Reported Event|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
601387|NCT00519090|E1|Reported Event|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
601388|NCT00519077|B1|Baseline|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
601389|NCT00519077|P1|Participant Flow|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
601390|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
601391|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
601392|NCT00519077|E1|Reported Event|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
601393|NCT00518986|B3|Baseline|Total|Total of all reporting groups
601394|NCT00518986|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601395|NCT00518986|B1|Baseline|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601396|NCT00518986|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601397|NCT00518986|P1|Participant Flow|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601398|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601399|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601400|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601401|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601687|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601402|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601403|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601404|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601405|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601406|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601407|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601408|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601409|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601410|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601411|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601412|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601413|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601526|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601688|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601689|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601414|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601415|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601416|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601417|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601418|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601419|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601420|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601421|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601422|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601423|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601424|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601425|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601527|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601690|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601691|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
612286|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
601426|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601427|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601428|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601429|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601430|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601431|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601432|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601433|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601434|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601435|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601436|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601437|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601528|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601692|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601693|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601438|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601439|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601440|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601441|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601442|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601443|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601444|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601445|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601446|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601447|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601448|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601449|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601529|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601694|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601695|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
612287|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
601450|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601451|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601452|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601453|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601454|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601455|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601456|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601457|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601458|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601459|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601460|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601461|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601530|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601696|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601697|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601462|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601463|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601464|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601465|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601466|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601467|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601468|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601469|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601470|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601471|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601472|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601473|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601531|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601698|NCT00518713|E4|Reported Event|Placebo|tablets; orally; daily for 15-18 weeks
601699|NCT00518713|E3|Reported Event|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601474|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601475|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601476|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601477|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601478|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601479|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601480|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601481|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601482|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601483|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601484|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601485|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601532|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601700|NCT00518713|E2|Reported Event|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601701|NCT00518713|E1|Reported Event|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601486|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601487|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601488|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601489|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601490|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601491|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601492|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601493|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601494|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601495|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601496|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601497|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601533|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601702|NCT00518687|B3|Baseline|Total|Total of all reporting groups
601703|NCT00518687|B2|Baseline|Placebo|Placebo : 0.5-ml single injection of matching placebo
601704|NCT00518687|B1|Baseline|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
601498|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601499|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601500|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601501|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601502|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601503|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601504|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601505|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601506|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601507|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601508|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601509|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601534|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601705|NCT00518687|P2|Participant Flow|Placebo|Placebo : 0.5-ml single injection of matching placebo
601706|NCT00518687|P1|Participant Flow|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
601510|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601511|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601512|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601513|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601514|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601515|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601516|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601517|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601518|NCT00518986|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
601519|NCT00518986|E1|Reported Event|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
601520|NCT00518882|B3|Baseline|Total|Total of all reporting groups
601521|NCT00518882|B2|Baseline|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601522|NCT00518882|B1|Baseline|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601523|NCT00518882|P2|Participant Flow|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601524|NCT00518882|P1|Participant Flow|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601525|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601535|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601536|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601537|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601538|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601539|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601540|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601541|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601542|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601543|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601544|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601545|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601546|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601547|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601548|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601549|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601550|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601551|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601552|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601553|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601554|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601555|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601556|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601557|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601676|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601677|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601558|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601559|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601560|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601561|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601562|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601563|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601564|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601565|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601566|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601567|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601568|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601569|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601570|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601571|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601572|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601573|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601574|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601575|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601576|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601577|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601578|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601579|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601580|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601678|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601679|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601581|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601582|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601583|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601584|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601585|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601586|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601587|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601588|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601589|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601590|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601591|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601592|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601593|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601594|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601595|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601596|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601597|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601598|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601599|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601600|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601601|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601602|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601603|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601680|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601681|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601604|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601605|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601606|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601607|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601608|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601609|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601610|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601611|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601612|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601613|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601614|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601615|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601616|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601617|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601618|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601619|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601620|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601621|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601622|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601623|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601624|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601625|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601626|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601682|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601683|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601627|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601628|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601629|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601630|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601631|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601632|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601633|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601634|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601635|NCT00518882|E2|Reported Event|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601636|NCT00518882|E1|Reported Event|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
601637|NCT00518713|B5|Baseline|Total|Total of all reporting groups
601638|NCT00518713|B4|Baseline|Placebo|tablets; orally; daily for 15-18 weeks
601639|NCT00518713|B3|Baseline|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601640|NCT00518713|B2|Baseline|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601641|NCT00518713|B1|Baseline|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601642|NCT00518713|P4|Participant Flow|Placebo|tablets; orally; daily for 15-18 weeks
601643|NCT00518713|P3|Participant Flow|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601644|NCT00518713|P2|Participant Flow|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601645|NCT00518713|P1|Participant Flow|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601646|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601647|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601648|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601649|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601650|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601651|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601652|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601653|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601654|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601655|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601656|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601657|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601658|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601659|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601660|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601661|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601662|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601663|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601664|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601665|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601666|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601667|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601668|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601669|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601670|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601671|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601672|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
601673|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
601674|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
601675|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
601707|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
601708|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
601709|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
601710|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
601711|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
601712|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
601713|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
601714|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
601715|NCT00518687|E2|Reported Event|Placebo|Placebo : 0.5-ml single injection of matching placebo
601716|NCT00518687|E1|Reported Event|V710 (60 µg) Lyophilized|V710: 0.5-ml single injection of V710 (60 µg)
601717|NCT00518622|B9|Baseline|Total|Total of all reporting groups
601718|NCT00518622|B8|Baseline|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
601719|NCT00518622|B7|Baseline|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
601720|NCT00518622|B6|Baseline|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
601721|NCT00518622|B5|Baseline|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601722|NCT00518622|B4|Baseline|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601723|NCT00518622|B3|Baseline|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601724|NCT00518622|B2|Baseline|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601725|NCT00518622|B1|Baseline|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601726|NCT00518622|P8|Participant Flow|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
601727|NCT00518622|P7|Participant Flow|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
601728|NCT00518622|P6|Participant Flow|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
601729|NCT00518622|P5|Participant Flow|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601730|NCT00518622|P4|Participant Flow|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601731|NCT00518622|P3|Participant Flow|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601732|NCT00518622|P2|Participant Flow|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601733|NCT00518622|P1|Participant Flow|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601734|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
601735|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
601736|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
601737|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601738|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601739|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601740|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601741|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601742|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
601743|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
601744|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
601745|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601746|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601747|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601748|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601749|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601750|NCT00518622|E8|Reported Event|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
601751|NCT00518622|E7|Reported Event|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
601752|NCT00518622|E6|Reported Event|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
601753|NCT00518622|E5|Reported Event|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601754|NCT00518622|E4|Reported Event|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601755|NCT00518622|E3|Reported Event|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601756|NCT00518622|E2|Reported Event|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601757|NCT00518622|E1|Reported Event|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
601758|NCT00518531|B3|Baseline|Total|Total of all reporting groups
601759|NCT00518531|B2|Baseline|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
601760|NCT00518531|B1|Baseline|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
601761|NCT00518531|P2|Participant Flow|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
601762|NCT00518531|P1|Participant Flow|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week (QW) for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
601763|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601764|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601765|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601766|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601767|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601768|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601769|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601770|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601771|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601772|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601773|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601774|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601775|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601776|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601777|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601778|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601779|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601780|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601781|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601782|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601783|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601784|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601785|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601786|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601787|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601788|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601789|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
601790|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
601791|NCT00518531|E4|Reported Event|Treatment Period 2: Denosumab|Participants who received alendronate 70 mg orally once a week in year 1 then received denosumab 60 mg subcutaneously every 6 months in year 2.
601792|NCT00518531|E3|Reported Event|Treatment Period 2: Alendronate|Participants who received denosumab 60 mg subcutaneously every 6 months in year 1 then received alendronate 70 mg orally once a week in year 2.
601793|NCT00518531|E2|Reported Event|Treatment Period 1: Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months in year 1.
601794|NCT00518531|E1|Reported Event|Treatment Period 1: Alendronate|Participants received alendronate 70 mg orally once a week in year 1.
601795|NCT00518349|B3|Baseline|Total|Total of all reporting groups
601796|NCT00518349|B2|Baseline|2 Standard Colonoscope|Colonoscopy using standard colonoscope without a passive bending function
601797|NCT00518349|B1|Baseline|1 Prototype Colonoscope|Colonoscopy using prototype colonoscope
601798|NCT00518349|P2|Participant Flow|Standard Colonoscope|Colonoscopy using standard colonoscope without a passive bending function
601799|NCT00518349|P1|Participant Flow|Prototype Colonoscope|Colonoscopy using prototype colonoscope
601800|NCT00518349|O2|Outcome|2 Standard Colonoscope|Colonoscopy using standard colonoscope without a passive bending function
601801|NCT00518349|O1|Outcome|1 Prototype Colonoscope|Colonoscopy using prototype colonoscope
601802|NCT00518349|E2|Reported Event|Standard Colonoscope|Colonoscope without a distal actively bending section
601803|NCT00518349|E1|Reported Event|Prototype Colonoscope|The prototype colonoscope is in effect a standard Olympus endoscope with one exception: about 10cm proximal to the distal, actively bending tip, there is a more falccid section which bends passively in all directions against external pressure. It is hypothesized that this will ease passage through sharp bends (flexures).
601804|NCT00518336|B3|Baseline|Total|Total of all reporting groups
601805|NCT00518336|B2|Baseline|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601806|NCT00518336|B1|Baseline|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601807|NCT00518336|P2|Participant Flow|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601808|NCT00518336|P1|Participant Flow|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601809|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601810|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601811|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601812|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601813|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601814|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601815|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601816|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601817|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601818|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601819|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601820|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601821|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601822|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601974|NCT00518323|P4|Participant Flow|Placebo|
602553|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
601823|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601824|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601825|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601826|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601827|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601828|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601829|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601830|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601831|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601832|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601833|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601834|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601835|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601836|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601837|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601838|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601839|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601840|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601841|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601842|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601843|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601975|NCT00518323|P3|Participant Flow|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
602554|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
601844|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601845|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601846|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601847|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601848|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601849|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601850|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601851|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601852|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601853|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601854|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601855|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601856|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601857|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601858|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601859|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601860|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601861|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601862|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601863|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601864|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601976|NCT00518323|P2|Participant Flow|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
601977|NCT00518323|P1|Participant Flow|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
601865|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601866|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601867|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601868|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601869|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601870|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601871|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601872|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601873|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601874|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601875|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601876|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601877|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601878|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601879|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601880|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601881|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601882|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601883|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601884|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601885|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601978|NCT00518323|O4|Outcome|Placebo|
601979|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
601886|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601887|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601888|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601889|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601890|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601891|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601892|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601893|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601894|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601895|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601896|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601897|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601898|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601899|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601900|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601901|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601902|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601903|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601904|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601905|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601906|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601980|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
601981|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
601907|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601908|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601909|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601910|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601911|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601912|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601913|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601914|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601915|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601916|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601917|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601918|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601919|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601920|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601921|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601922|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601923|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601924|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601925|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601926|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601927|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601982|NCT00518323|O4|Outcome|Placebo|
601983|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
601928|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601929|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601930|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601931|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601932|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601933|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601934|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601935|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601936|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601937|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601938|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601939|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601940|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601941|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601942|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601943|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601944|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601945|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601946|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601947|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601948|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601984|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
601985|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
601949|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601950|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601951|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601952|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601953|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601954|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601955|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601956|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601957|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601958|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601959|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601960|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601961|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601962|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601963|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601964|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601965|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601966|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601967|NCT00518336|E2|Reported Event|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601968|NCT00518336|E1|Reported Event|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
601969|NCT00518323|B5|Baseline|Total|Total of all reporting groups
601970|NCT00518323|B4|Baseline|Placebo|
601971|NCT00518323|B3|Baseline|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
601972|NCT00518323|B2|Baseline|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
601973|NCT00518323|B1|Baseline|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
601987|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
601988|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
601989|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
601990|NCT00518323|O4|Outcome|Placebo|
601991|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
601992|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
601993|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
601994|NCT00518323|O4|Outcome|Placebo|
601995|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
601996|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
601997|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
601998|NCT00518323|E4|Reported Event|Placebo|
601999|NCT00518323|E3|Reported Event|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
602000|NCT00518323|E2|Reported Event|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
602001|NCT00518323|E1|Reported Event|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
602002|NCT00518284|B5|Baseline|Total|Total of all reporting groups
602003|NCT00518284|B4|Baseline|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602004|NCT00518284|B3|Baseline|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602005|NCT00518284|B2|Baseline|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602006|NCT00518284|B1|Baseline|Control|Following revascularization, participants did not receive any study drug treatment.
602007|NCT00518284|P4|Participant Flow|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602008|NCT00518284|P3|Participant Flow|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602009|NCT00518284|P2|Participant Flow|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602010|NCT00518284|P1|Participant Flow|Control|Following revascularization, participants did not receive any study drug treatment.
602011|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602012|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602013|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602014|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602015|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602016|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602017|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602018|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602019|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602020|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602021|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602022|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602023|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602024|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602555|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602025|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602026|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602027|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602028|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602029|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602030|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602031|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602032|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602033|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602034|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602035|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602036|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602037|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602038|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602039|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602040|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602041|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602042|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602043|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602044|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602045|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602046|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602047|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602048|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602049|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602050|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602051|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602052|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602053|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602054|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602055|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602056|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602321|NCT00518011|B1|Baseline|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602057|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602058|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
602059|NCT00518284|E4|Reported Event|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602060|NCT00518284|E3|Reported Event|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
602061|NCT00518284|E2|Reported Event|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
602062|NCT00518284|E1|Reported Event|Control|Following revascularization, participants did not receive any study drug treatment.
602063|NCT00518206|B3|Baseline|Total|Total of all reporting groups
602064|NCT00518206|B2|Baseline|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602065|NCT00518206|B1|Baseline|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602066|NCT00518206|P2|Participant Flow|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602067|NCT00518206|P1|Participant Flow|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602068|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602069|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602070|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602071|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602072|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602073|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602074|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602075|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602076|NCT00518206|O2|Outcome|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602077|NCT00518206|O1|Outcome|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602078|NCT00518206|E2|Reported Event|Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM|Subjects received cyclophosphamide (300 mg/m^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602079|NCT00518206|E1|Reported Event|Cohort 1: NY-ESO-1 ISCOM|Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
602080|NCT00518180|B4|Baseline|Total|Total of all reporting groups
602081|NCT00518180|B3|Baseline|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602082|NCT00518180|B2|Baseline|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602363|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602083|NCT00518180|B1|Baseline|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602084|NCT00518180|P3|Participant Flow|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602085|NCT00518180|P2|Participant Flow|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602086|NCT00518180|P1|Participant Flow|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602087|NCT00518180|O3|Outcome|Tdap → MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
602088|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV at months 2, 4, and 8
602089|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
602090|NCT00518180|O3|Outcome|Tdap → MenACWY →HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602091|NCT00518180|O2|Outcome|MenACWY→Tdap → HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602092|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602093|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602094|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602095|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602096|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602097|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
602098|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602099|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602100|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
602101|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602102|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602103|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
602104|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602105|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602106|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
602107|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602108|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602109|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602110|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602111|NCT00518180|O2|Outcome|HPV Alone|The three injections of the HPV vaccine was administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
602112|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602113|NCT00518180|O2|Outcome|HPV Alone|Three injections of the HPV vaccine were administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
602365|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602114|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602115|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602116|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
602117|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602118|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602119|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602120|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602121|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602122|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
602123|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
602124|NCT00518180|E3|Reported Event|Tdap → MenACWY → HPV|Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.
602125|NCT00518180|E2|Reported Event|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.
602126|NCT00518180|E1|Reported Event|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
602127|NCT00518115|B11|Baseline|Total|Total of all reporting groups
602128|NCT00518115|B10|Baseline|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602129|NCT00518115|B9|Baseline|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602130|NCT00518115|B8|Baseline|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602131|NCT00518115|B7|Baseline|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602132|NCT00518115|B6|Baseline|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602133|NCT00518115|B5|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602134|NCT00518115|B4|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602135|NCT00518115|B3|Baseline|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602136|NCT00518115|B2|Baseline|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602137|NCT00518115|B1|Baseline|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602138|NCT00518115|P10|Participant Flow|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602139|NCT00518115|P9|Participant Flow|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602140|NCT00518115|P8|Participant Flow|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602141|NCT00518115|P7|Participant Flow|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602142|NCT00518115|P6|Participant Flow|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602143|NCT00518115|P5|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602144|NCT00518115|P4|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602145|NCT00518115|P3|Participant Flow|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602146|NCT00518115|P2|Participant Flow|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602147|NCT00518115|P1|Participant Flow|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602148|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
602149|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
602150|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
602151|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
602152|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602153|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602154|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602155|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602156|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602157|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602158|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602159|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602160|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602161|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602364|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602162|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602163|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602164|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602165|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602166|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602167|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602168|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602169|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602170|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602171|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602172|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602173|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602174|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602175|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602176|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602177|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602178|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602179|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602180|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602181|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602182|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602183|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602184|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602185|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602457|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602186|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602187|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602188|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602189|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602190|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602191|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602192|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602193|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602194|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602195|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602196|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602197|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602198|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602199|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602200|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602201|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602202|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602203|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602204|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602205|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602206|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602207|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602208|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602209|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602320|NCT00518011|B2|Baseline|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602210|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602211|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602212|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602213|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602214|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602215|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602216|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602217|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602218|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602219|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602220|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602221|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602222|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602223|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602224|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602225|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602226|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602227|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602228|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602229|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602230|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602231|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602232|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602233|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602458|NCT00517751|E1|Reported Event|X-STOP PEEK|In this arm, patients will undergo X-STOP PEEK surgery.
602234|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602235|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602236|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602237|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602238|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602239|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602240|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602241|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602242|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602243|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602244|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602245|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602246|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602247|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602248|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602249|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602250|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602251|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602252|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602253|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602254|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602255|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602256|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602257|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602492|NCT00517556|B3|Baseline|Total|Total of all reporting groups
602258|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602259|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602260|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602261|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602262|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602263|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602264|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602265|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602266|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602267|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602268|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602269|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602270|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602271|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602272|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602273|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602274|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602275|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602276|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602277|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602278|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602279|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602280|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602281|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602556|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602282|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602283|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602284|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602285|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602286|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602287|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602288|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602289|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602290|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602291|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602292|NCT00518115|E10|Reported Event|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602293|NCT00518115|E9|Reported Event|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602294|NCT00518115|E8|Reported Event|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602295|NCT00518115|E7|Reported Event|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602296|NCT00518115|E6|Reported Event|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602297|NCT00518115|E5|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602298|NCT00518115|E4|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602299|NCT00518115|E3|Reported Event|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602300|NCT00518115|E2|Reported Event|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
602301|NCT00518115|E1|Reported Event|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
602302|NCT00518089|B3|Baseline|Total|Total of all reporting groups
602303|NCT00518089|B2|Baseline|Placebo Eye Drops|
602304|NCT00518089|B1|Baseline|Gatifloxacin 0.5% Eye Drops|
602305|NCT00518089|P2|Participant Flow|Placebo Eye Drops|
602306|NCT00518089|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|
602307|NCT00518089|O2|Outcome|Placebo Eye Drops|
602308|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
602309|NCT00518089|O2|Outcome|Placebo Eye Drops|
602310|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
602311|NCT00518089|O2|Outcome|Placebo Eye Drops|
602312|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
602313|NCT00518089|O2|Outcome|Placebo Eye Drops|
602314|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
602315|NCT00518089|O2|Outcome|Placebo Eye Drops|
602316|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
602317|NCT00518089|E2|Reported Event|Placebo Eye Drops|
602318|NCT00518089|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|
602322|NCT00518011|P2|Participant Flow|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602323|NCT00518011|P1|Participant Flow|Gemcitabine|Participants received Gemcitabine 1000 milligram per meter square (mg/m^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles
602324|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602325|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602326|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602327|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602328|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602329|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602330|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602331|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602332|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602333|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
602334|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602335|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602336|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602337|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602338|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602339|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602340|NCT00518011|E2|Reported Event|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
602341|NCT00518011|E1|Reported Event|Gemcitabine|Participants received Gemcitabine (1000 mg/m^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles
602342|NCT00517933|B3|Baseline|Total|Total of all reporting groups
602343|NCT00517933|B2|Baseline|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602344|NCT00517933|B1|Baseline|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
602345|NCT00517933|P2|Participant Flow|Placebo / Sildenafil|20 mg oral placebo 3 times per day
602346|NCT00517933|P1|Participant Flow|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
602347|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602348|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602349|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602350|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602351|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602352|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602353|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602354|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602355|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602356|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602357|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602358|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602359|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602360|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602361|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602362|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602366|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602367|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602368|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602369|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602370|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602371|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602372|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602373|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602374|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602375|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602376|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602377|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602378|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602379|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602380|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602381|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602382|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602383|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602384|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602385|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602386|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602387|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
602388|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
602389|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
602390|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
602391|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
602392|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
602393|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
602394|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
602395|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602396|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602397|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602398|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
602399|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
602400|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
602401|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602402|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602403|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602404|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602405|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602406|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
602407|NCT00517933|E2|Reported Event|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
602408|NCT00517933|E1|Reported Event|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
602409|NCT00517881|B1|Baseline|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602493|NCT00517556|B2|Baseline|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
602410|NCT00517881|P1|Participant Flow|C.E.R.A.|Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602411|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602412|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602413|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602414|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602415|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602416|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602417|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602418|NCT00517881|E1|Reported Event|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
602419|NCT00517829|B3|Baseline|Total|Total of all reporting groups
602420|NCT00517829|B2|Baseline|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602421|NCT00517829|B1|Baseline|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602422|NCT00517829|P2|Participant Flow|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602423|NCT00517829|P1|Participant Flow|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602424|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602425|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602426|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602427|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602428|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602429|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602430|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602431|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602432|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602433|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602434|NCT00517829|E2|Reported Event|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
602435|NCT00517829|E1|Reported Event|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
602436|NCT00517751|B1|Baseline|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602437|NCT00517751|P1|Participant Flow|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602438|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602439|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602440|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602441|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602442|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602443|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602444|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602445|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602446|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602447|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602448|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602449|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602450|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602451|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602452|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602453|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602454|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602455|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602456|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
602459|NCT00517699|B1|Baseline|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602460|NCT00517699|P1|Participant Flow|Rituximab, Cytarabine, and Methotrexate (MTX)|Participants received single doses of rituximab 750 milligrams per square meter (mg/m^2) intravenously (IV) at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 grams per square meter (g/m^2) IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602461|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602462|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602463|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602464|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602465|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602466|NCT00517699|E1|Reported Event|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
602467|NCT00517634|B1|Baseline|Overall Study Population|Overall Study Population: participants in all three treatment periods
602468|NCT00517634|P6|Participant Flow|Sequence 6: Placebo, FP, SFC|Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
602469|NCT00517634|P5|Participant Flow|Sequence 5: FP, Placebo, SFC|Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
602470|NCT00517634|P4|Participant Flow|Sequence 4: SFC, Placebo, FP|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
602471|NCT00517634|P3|Participant Flow|Sequence 3: SFC, FP, Placebo|Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
602472|NCT00517634|P2|Participant Flow|Sequence 2: Placebo, SFC, FP|Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
602473|NCT00517634|P1|Participant Flow|Sequence 1: FP, SFC, Placebo|Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
602474|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
602475|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
602476|NCT00517634|O1|Outcome|Placebo|Placebo
602477|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
602478|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
602479|NCT00517634|O1|Outcome|Placebo|Placebo
602480|NCT00517634|E3|Reported Event|SFC 50/100 BID|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID
602481|NCT00517634|E2|Reported Event|FP 100 mcg BID|Fluticasone Propionate 100 mcg BID
602482|NCT00517634|E1|Reported Event|Placebo|Placebo
602483|NCT00517595|B1|Baseline|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602484|NCT00517595|P1|Participant Flow|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602485|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602486|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602487|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602488|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602489|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602490|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602491|NCT00517595|E1|Reported Event|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
602494|NCT00517556|B1|Baseline|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
602495|NCT00517556|P2|Participant Flow|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
602496|NCT00517556|P1|Participant Flow|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
602497|NCT00517556|O2|Outcome|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
602498|NCT00517556|O1|Outcome|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
602499|NCT00517556|E2|Reported Event|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
602500|NCT00517556|E1|Reported Event|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
602501|NCT00517530|B8|Baseline|Total|Total of all reporting groups
602502|NCT00517530|B7|Baseline|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
602503|NCT00517530|B6|Baseline|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602504|NCT00517530|B5|Baseline|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602505|NCT00517530|B4|Baseline|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602506|NCT00517530|B3|Baseline|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602507|NCT00517530|B2|Baseline|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
602508|NCT00517530|B1|Baseline|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
602509|NCT00517530|P7|Participant Flow|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
602510|NCT00517530|P6|Participant Flow|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602511|NCT00517530|P5|Participant Flow|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602512|NCT00517530|P4|Participant Flow|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602513|NCT00517530|P3|Participant Flow|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602514|NCT00517530|P2|Participant Flow|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
602515|NCT00517530|P1|Participant Flow|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
602516|NCT00517530|O4|Outcome|2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602517|NCT00517530|O3|Outcome|1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602518|NCT00517530|O2|Outcome|800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602519|NCT00517530|O1|Outcome|400 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602520|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602521|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602522|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602523|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602524|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602525|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602526|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602527|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602528|NCT00517530|O1|Outcome|Retreated Participants|Obinutuzumab intravenous infusion
602529|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
602530|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602531|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602532|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602533|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602534|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
602535|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602536|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602537|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602538|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602539|NCT00517530|O3|Outcome|Phase II, CLL|Obinutuzumab intravenous infusion at 1000/1000 mg
602540|NCT00517530|O2|Outcome|Phase II, aNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
602541|NCT00517530|O1|Outcome|Phase II, iNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
602542|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
602543|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602544|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602545|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602546|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602547|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
602548|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602549|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602550|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602551|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602552|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
612288|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
602557|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
602558|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602559|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
602560|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602561|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
602562|NCT00517530|O11|Outcome|1000/1000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602563|NCT00517530|O10|Outcome|1200/2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602564|NCT00517530|O9|Outcome|800/1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602565|NCT00517530|O8|Outcome|400/800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
602566|NCT00517530|O7|Outcome|1600/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602567|NCT00517530|O6|Outcome|1200/2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602568|NCT00517530|O5|Outcome|800/1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602569|NCT00517530|O4|Outcome|400/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602570|NCT00517530|O3|Outcome|200/400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602571|NCT00517530|O2|Outcome|100/200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602572|NCT00517530|O1|Outcome|50/100 mg - Phase I, NHL|Obinutuzumab intravenous infusion
602573|NCT00517530|E1|Reported Event|Safety Population|Safety-Evaluable Participants
602574|NCT00517413|B1|Baseline|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602575|NCT00517413|P1|Participant Flow|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta [Mircera]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602576|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602577|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602578|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602579|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602580|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602581|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602582|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602583|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602584|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602585|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602586|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602587|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
603749|NCT00514813|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
602588|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602589|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602590|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602591|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602592|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602593|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602594|NCT00517413|E1|Reported Event|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
602595|NCT00517361|B1|Baseline|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
602596|NCT00517361|P1|Participant Flow|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
602597|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
602598|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
602599|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
602600|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
602601|NCT00517361|E1|Reported Event|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
602602|NCT00517296|B3|Baseline|Total|Total of all reporting groups
602603|NCT00517296|B2|Baseline|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
602604|NCT00517296|B1|Baseline|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
602605|NCT00517296|P2|Participant Flow|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
602606|NCT00517296|P1|Participant Flow|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
602607|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
602608|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
602609|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
602610|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
602611|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
602612|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
602613|NCT00517296|E2|Reported Event|B, Control Arm|Group B patients will be randomized to surgical guidance / standard of care
602614|NCT00517296|E1|Reported Event|A, Combination Therapy Group|"Group A patients will be randomized to TNF and seton placement.~Seton placement: Patients randomized to the combination therapy group will have seton placement prior to initiating therapy with Certolizumab."
602615|NCT00517192|B3|Baseline|Total|Total of all reporting groups
602616|NCT00517192|B2|Baseline|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602617|NCT00517192|B1|Baseline|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602749|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602618|NCT00517192|P2|Participant Flow|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602619|NCT00517192|P1|Participant Flow|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602620|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602621|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602622|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602623|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602624|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602625|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602626|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602627|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602628|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602629|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602630|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602631|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602632|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602633|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602634|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602635|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602636|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602637|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602638|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602639|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602640|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602641|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602642|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602643|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602644|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602645|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602646|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602647|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602648|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602649|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602650|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
612289|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
602651|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602652|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602653|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602654|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602655|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602656|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602657|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602658|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602659|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602660|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602661|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602662|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602663|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602664|NCT00517192|E2|Reported Event|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
602665|NCT00517192|E1|Reported Event|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
602666|NCT00517075|B5|Baseline|Total|Total of all reporting groups
602667|NCT00517075|B4|Baseline|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602668|NCT00517075|B3|Baseline|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602669|NCT00517075|B2|Baseline|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602670|NCT00517075|B1|Baseline|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602671|NCT00517075|P4|Participant Flow|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602672|NCT00517075|P3|Participant Flow|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602673|NCT00517075|P2|Participant Flow|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602674|NCT00517075|P1|Participant Flow|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602675|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602676|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602677|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602678|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602679|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602680|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602739|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
602740|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
612290|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
602681|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602682|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602683|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602684|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602685|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602686|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602687|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602688|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602689|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602741|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
602742|NCT00516893|E1|Reported Event|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
602743|NCT00516737|B3|Baseline|Total|Total of all reporting groups
612291|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
602690|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602691|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602692|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602693|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602694|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602695|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602696|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602697|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602698|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602744|NCT00516737|B2|Baseline|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602745|NCT00516737|B1|Baseline|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602746|NCT00516737|P2|Participant Flow|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602750|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602699|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602700|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602701|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602702|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602703|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602704|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602705|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602706|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602707|NCT00517075|E4|Reported Event|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602747|NCT00516737|P1|Participant Flow|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602748|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602708|NCT00517075|E3|Reported Event|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602709|NCT00517075|E2|Reported Event|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602710|NCT00517075|E1|Reported Event|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
602711|NCT00517010|B1|Baseline|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
602712|NCT00517010|P1|Participant Flow|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
602713|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
602714|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
602715|NCT00517010|E1|Reported Event|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
602716|NCT00516919|B1|Baseline|Total Enrollment|
602717|NCT00516919|P2|Participant Flow|Placebo + Behavioral Intervention|"Drug: Placebo + Behavioral: behavioral intervention~Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day"
602718|NCT00516919|P1|Participant Flow|Xenical + Behavioral Intervention|"Drug: Xenical + Behavioral: behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
602719|NCT00516919|O2|Outcome|Drug: Placebo + Behavioral: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
602720|NCT00516919|O1|Outcome|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
602721|NCT00516919|E2|Reported Event|Drug: Placebo + Behaviora: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
602722|NCT00516919|E1|Reported Event|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
602723|NCT00516906|B3|Baseline|Total|Total of all reporting groups
602724|NCT00516906|B2|Baseline|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
602725|NCT00516906|B1|Baseline|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
602726|NCT00516906|P2|Participant Flow|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
602727|NCT00516906|P1|Participant Flow|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
602728|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
602729|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
602730|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
602731|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
602732|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
602733|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
602734|NCT00516906|E2|Reported Event|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
602735|NCT00516906|E1|Reported Event|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
602736|NCT00516893|B1|Baseline|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
602737|NCT00516893|P1|Participant Flow|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
602738|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
602751|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602752|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602753|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602754|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602755|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602756|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602757|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602758|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602759|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602760|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602761|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602762|NCT00516737|E2|Reported Event|Placebo|Matching placebo; one dose, treatment of a single migraine attack
602763|NCT00516737|E1|Reported Event|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
602764|NCT00516503|B3|Baseline|Total|Total of all reporting groups
602765|NCT00516503|B2|Baseline|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602766|NCT00516503|B1|Baseline|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602767|NCT00516503|P2|Participant Flow|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602768|NCT00516503|P1|Participant Flow|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602769|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602770|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602771|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602772|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602773|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602774|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602775|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602776|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602777|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602778|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602779|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602780|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602781|NCT00516503|O2|Outcome|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602782|NCT00516503|O1|Outcome|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602783|NCT00516503|E2|Reported Event|Placebo|Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
602867|NCT00516217|B1|Baseline|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
612292|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
602784|NCT00516503|E1|Reported Event|Baclofen-amitriptyline Hydrochloride-ketamine|Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
602785|NCT00516386|B1|Baseline|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
602786|NCT00516386|P1|Participant Flow|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
602787|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
602788|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
602789|NCT00516386|E1|Reported Event|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
602790|NCT00516321|B3|Baseline|Total|Total of all reporting groups
602791|NCT00516321|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602792|NCT00516321|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602793|NCT00516321|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602794|NCT00516321|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602795|NCT00516321|P1|Participant Flow|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
602796|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602797|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602798|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602799|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602800|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602801|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602802|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602803|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602804|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602868|NCT00516217|P1|Participant Flow|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
603750|NCT00514813|B2|Baseline|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
602805|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602806|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602807|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602808|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602809|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602810|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602811|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602812|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602813|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602814|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602815|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602816|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602817|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602818|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602819|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602820|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602821|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602822|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602823|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602824|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602825|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602826|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602827|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602828|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602829|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602830|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602831|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602832|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602833|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602834|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
602835|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
602836|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
602837|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602838|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602839|NCT00516321|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602840|NCT00516321|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
602841|NCT00516321|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
602842|NCT00516295|B4|Baseline|Total|Total of all reporting groups
602843|NCT00516295|B3|Baseline|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
602844|NCT00516295|B2|Baseline|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I
602845|NCT00516295|B1|Baseline|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
602846|NCT00516295|P3|Participant Flow|Arm III (CTC)|Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.
602847|NCT00516295|P2|Participant Flow|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
602848|NCT00516295|P1|Participant Flow|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
602849|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
602850|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
602851|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
602852|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
602853|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
602854|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
602855|NCT00516295|E3|Reported Event|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
602856|NCT00516295|E2|Reported Event|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
602857|NCT00516295|E1|Reported Event|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
602858|NCT00516269|B3|Baseline|Total|Total of all reporting groups
602859|NCT00516269|B2|Baseline|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
602860|NCT00516269|B1|Baseline|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
602861|NCT00516269|P2|Participant Flow|Placebo Then Methylphenidate|Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
602862|NCT00516269|P1|Participant Flow|Methylphenidate Then Placebo|Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks
602863|NCT00516269|O2|Outcome|Placebo|Placebo taken oral daily for 2 Weeks.
602864|NCT00516269|O1|Outcome|Methylphenidate|Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.
602865|NCT00516269|E2|Reported Event|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
602866|NCT00516269|E1|Reported Event|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
603751|NCT00514813|B1|Baseline|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
602869|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
602870|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
602871|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
602872|NCT00516217|E1|Reported Event|Galaximab|Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
602873|NCT00516165|B1|Baseline|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602874|NCT00516165|P1|Participant Flow|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602875|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602876|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602877|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602878|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602879|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602880|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602881|NCT00516165|E1|Reported Event|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
602882|NCT00516139|B1|Baseline|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602883|NCT00516139|P1|Participant Flow|Lamotrigine (LTG)-Extended Release (XR) Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602884|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602926|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602927|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602928|NCT00516074|E2|Reported Event|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602929|NCT00516074|E1|Reported Event|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602885|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602886|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602887|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602888|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602889|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602890|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602891|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602930|NCT00516048|B3|Baseline|Total|Total of all reporting groups
602931|NCT00516048|B2|Baseline|Positive Baseline (Week 0) Antibody Status|Patients assessed as positive for antibodies to exenatide at baseline (Week 0).
602932|NCT00516048|B1|Baseline|Negative Baseline (Week 0) Antibody Status|Patients assessed as negative for antibodies to exenatide at baseline (Week 0).
602933|NCT00516048|P3|Participant Flow|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
612293|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
602892|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602893|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602894|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602895|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602896|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602897|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602898|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602934|NCT00516048|P2|Participant Flow|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
602935|NCT00516048|P1|Participant Flow|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
612294|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
602899|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602900|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602901|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602902|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602903|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602904|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602905|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602936|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
602937|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
603834|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
602906|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602907|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602908|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602909|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602910|NCT00516139|E1|Reported Event|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
602911|NCT00516074|B3|Baseline|Total|Total of all reporting groups
602912|NCT00516074|B2|Baseline|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602913|NCT00516074|B1|Baseline|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602914|NCT00516074|P2|Participant Flow|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602915|NCT00516074|P1|Participant Flow|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602916|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602917|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602918|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602919|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602920|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602921|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602922|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602923|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
602924|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
602925|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
603835|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
602938|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
602939|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
602940|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
602941|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
602942|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
602943|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
602944|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
602945|NCT00516048|E3|Reported Event|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
602946|NCT00516048|E2|Reported Event|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
602947|NCT00516048|E1|Reported Event|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
602948|NCT00515879|B3|Baseline|Total|Total of all reporting groups
602949|NCT00515879|B2|Baseline|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
602950|NCT00515879|B1|Baseline|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
602951|NCT00515879|P2|Participant Flow|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
602952|NCT00515879|P1|Participant Flow|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
602953|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
602954|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
602955|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
602956|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
602957|NCT00515879|E2|Reported Event|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
602958|NCT00515879|E1|Reported Event|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
602959|NCT00515827|B3|Baseline|Total|Total of all reporting groups
602960|NCT00515827|B2|Baseline|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
602961|NCT00515827|B1|Baseline|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
602962|NCT00515827|P2|Participant Flow|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
602963|NCT00515827|P1|Participant Flow|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
602964|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
602965|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602966|NCT00515827|O2|Outcome|Raltegravir (Arm B)|400 mg raltegravir (MK-0518) administered twice daily in addition to OBR from week 12 to week 24
602967|NCT00515827|O1|Outcome|Placebo (Arm A)|Placebo administered twice daily in addition to optimized background regimen (OBR) from week 12 to week 24
602968|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
602969|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602970|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
602971|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602972|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
602973|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602974|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
602975|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602976|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
602977|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602978|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
603836|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
602979|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602980|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
602981|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
602982|NCT00515827|E2|Reported Event|Placebo|Week 12 to Week 24 for Arm A (Raltegravir then Placebo), and Baseline to Week 12 for Arm B (Placebo then Raltegravir).
602983|NCT00515827|E1|Reported Event|Raltegravir|Baseline to Week 12 for Arm A (Raltegravir then Placebo), and Week 12 to Week 24 for Arm B (Placebo then Raltegravir).
602984|NCT00515697|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602985|NCT00515697|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602986|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602987|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602988|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602989|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602990|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602991|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602992|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602993|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602994|NCT00515697|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
602995|NCT00515671|B3|Baseline|Total|Total of all reporting groups
602996|NCT00515671|B2|Baseline|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
602997|NCT00515671|B1|Baseline|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
602998|NCT00515671|P2|Participant Flow|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
602999|NCT00515671|P1|Participant Flow|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
603000|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
603001|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
603002|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
603003|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
603004|NCT00515671|E2|Reported Event|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
603005|NCT00515671|E1|Reported Event|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
603006|NCT00515619|B1|Baseline|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603007|NCT00515619|P1|Participant Flow|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603008|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603837|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603009|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603010|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603011|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603012|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603013|NCT00515619|E1|Reported Event|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
603014|NCT00515541|B5|Baseline|Total|Total of all reporting groups
603015|NCT00515541|B4|Baseline|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject is taking Warfarin and Aspirin (< or = 325mg)and is not taking Clopidogrel. Subject is taking escalating doses of Lovaza over a 24 week period.
603016|NCT00515541|B3|Baseline|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject is taking Clopidogrel 75mg)and Aspirin (< or = 325mg) and not taking Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
603017|NCT00515541|B2|Baseline|Group. B: Subject on Lovaza + Aspirin|Group B: Subject on Aspirin (< or = 325mg and is not taking Clopidogrel or Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
603018|NCT00515541|B1|Baseline|Group A: Subject on Lovaza Only|Group A: Subject is not on Aspirin, Clopidogrel, or Warfarin. Subject is taking escalating doses of study drug (Lovaza)over a 24 week period.
603019|NCT00515541|P4|Participant Flow|Group D: Subjects on Lovaza Plus Warfarin and Aspirin|Subject is regularly taking Warfarin and Aspirin (< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.
603020|NCT00515541|P3|Participant Flow|Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin|Subject is regularly taking Clopidogrel (75mg)and Aspirin (< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.
603021|NCT00515541|P2|Participant Flow|Group B: Subjects on Lovaza Plus Aspirin|Group B: Subject is only taking Aspirin (< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.
603022|NCT00515541|P1|Participant Flow|Group A: Subjects on Lovaza Only|Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.
603023|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
603024|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603025|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603026|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603027|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
603028|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603029|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603030|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603031|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
603032|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603033|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603034|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603035|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
603036|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603037|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603038|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
603039|NCT00515541|E4|Reported Event|Group D|Lovaza plus aspirin plus coumadin
603040|NCT00515541|E3|Reported Event|Group C|Lovaza plus clopidogrel
603041|NCT00515541|E2|Reported Event|Group B|Lovaza plus aspirin
603042|NCT00515541|E1|Reported Event|Group A|Lovaza only
603228|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603043|NCT00515502|B1|Baseline|All Study Treatments|Participants received a sequence containing 4 of the following 5 possible treatments: placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and Tiotropium 18 µg. Participants received each of the treatments in 1 of 4 single dose treatment periods, each of which was followed by a washout period. Treatment periods 1, 2, and 3 were followed by at least a 14-day washout period; Treatment period 4 was followed by a Follow-up visit within 10 days.
603044|NCT00515502|P12|Participant Flow|Seq 12: UMEC 250 µg, Placebo, UMEC 500 µg, Tiotropium 18 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and Tiotropium 18 µg. Treatment periods were seperated by a washout period of at least 14 days.
603045|NCT00515502|P11|Participant Flow|Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
603046|NCT00515502|P10|Participant Flow|Seq 10: Tiotropium 18 µg, UMEC 250 µg, Placebo, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, placebo and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
603047|NCT00515502|P9|Participant Flow|Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
603048|NCT00515502|P8|Participant Flow|Seq 8: Tiotropium 18 µg, Placebo, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, placebo, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
603049|NCT00515502|P7|Participant Flow|Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, Tiotropium 18 µg, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
603050|NCT00515502|P6|Participant Flow|Seq 6: UMEC 250 µg, Placebo, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
603051|NCT00515502|P5|Participant Flow|Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
603052|NCT00515502|P4|Participant Flow|Seq 4: UMEC 250 µg, UMEC 500 µg, Placebo, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, placebo and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
603053|NCT00515502|P3|Participant Flow|Seq 3: UMEC 250 µg, Placebo, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
603054|NCT00515502|P2|Participant Flow|Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
603055|NCT00515502|P1|Participant Flow|Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
603056|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603057|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603058|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603059|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603060|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603061|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603062|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603063|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603064|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603065|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603066|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603067|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603068|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603069|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603070|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603071|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603072|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603073|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603074|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603075|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603076|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603077|NCT00515502|O1|Outcome|UMEC 250 µg|
603078|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603079|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603080|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603081|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603082|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603083|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603084|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603085|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603086|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603087|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603088|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603089|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603090|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603091|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603092|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603093|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603094|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603095|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603096|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603097|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603098|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603099|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603100|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603101|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603102|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603103|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603104|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603105|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603106|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603107|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603108|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603109|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603110|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603111|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603112|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603113|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603114|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603115|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603116|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603117|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603118|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603119|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603120|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603121|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603122|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603123|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603124|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603125|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603126|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603127|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603128|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603129|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603130|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
612295|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162**
603131|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603132|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603133|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603134|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603135|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603136|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603137|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603138|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603139|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603140|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603141|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603142|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603143|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603144|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603145|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603146|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603147|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603148|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603149|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603150|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603151|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603152|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603153|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603154|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603155|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603156|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603157|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603158|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603159|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603160|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603161|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
612296|NCT00490945|O1|Outcome|Placebo*|Randomized to Placebo
603162|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603163|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603164|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603165|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603166|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603167|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603168|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603169|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603170|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603171|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603172|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603173|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603174|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603175|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603176|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603177|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603178|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603179|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603180|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603181|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603182|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603183|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603184|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603185|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603186|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603187|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603188|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603189|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603190|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603191|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603192|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
612297|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
603193|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603194|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603195|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603196|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603197|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603198|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603199|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603200|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603201|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603202|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603203|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603204|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603205|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 micrograms (µg) via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603206|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603207|NCT00515502|E5|Reported Event|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603208|NCT00515502|E4|Reported Event|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603209|NCT00515502|E3|Reported Event|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603210|NCT00515502|E2|Reported Event|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603211|NCT00515502|E1|Reported Event|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
603212|NCT00515463|B3|Baseline|Total|Total of all reporting groups
603213|NCT00515463|B2|Baseline|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603214|NCT00515463|B1|Baseline|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603215|NCT00515463|P2|Participant Flow|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603216|NCT00515463|P1|Participant Flow|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603217|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603218|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603219|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603220|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603221|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603222|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603223|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603224|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603225|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603226|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603227|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603438|NCT00515203|B2|Baseline|Placebo|Placebo by subcutaneous injection once weekly
603229|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603230|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603231|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603232|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603233|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603234|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603235|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603236|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603237|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603238|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603239|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603240|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603241|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603242|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603243|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603244|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603245|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603246|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603247|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603248|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603249|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603250|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603251|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603252|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603253|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603254|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603255|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603256|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603257|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603258|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603259|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603260|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603261|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603262|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603263|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603264|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603265|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603266|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603267|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603268|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603269|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603270|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
612298|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
603271|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603272|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603273|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603274|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603275|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603276|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603277|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603278|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603279|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603280|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603281|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603282|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603283|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603284|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603285|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603286|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603287|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603288|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603289|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603290|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603291|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603292|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603293|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603294|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603295|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603296|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603297|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603298|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603299|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603300|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603301|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603302|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603303|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603304|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603305|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603306|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603307|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603308|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603309|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603310|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603311|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603312|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
612299|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
603313|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603314|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603315|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603316|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603317|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603318|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603319|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603320|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603321|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603322|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603323|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603324|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603325|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603326|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603327|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603328|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603329|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603330|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603331|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603332|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603333|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603334|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603335|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603336|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603337|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603338|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603339|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603340|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603341|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603342|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603343|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603344|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603345|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603346|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603347|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603348|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603349|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603350|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603351|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603352|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603353|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603354|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
612300|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
603355|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603356|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603357|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603358|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603359|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603360|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603361|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe (PFS) on Day 1 and at Month 6.
603362|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603363|NCT00515463|E2|Reported Event|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
603364|NCT00515463|E1|Reported Event|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
603365|NCT00515437|B5|Baseline|Total|Total of all reporting groups
603366|NCT00515437|B4|Baseline|Placebo|Placebo
603367|NCT00515437|B3|Baseline|3500U Myobloc|3500U Myobloc
603368|NCT00515437|B2|Baseline|2500U Myobloc|2500U Myobloc
603369|NCT00515437|B1|Baseline|1500U Myobloc|1500U Myobloc
603370|NCT00515437|P4|Participant Flow|Placebo|Placebo
603371|NCT00515437|P3|Participant Flow|3500U Myobloc|3500U Myobloc
603372|NCT00515437|P2|Participant Flow|2500U Myobloc|2500U Myobloc
603373|NCT00515437|P1|Participant Flow|1500U Myobloc|1500U Myobloc
603374|NCT00515437|O4|Outcome|Placebo|Placebo
603375|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
603376|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
603377|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
603378|NCT00515437|O4|Outcome|Placebo|Placebo
603379|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
603380|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
603381|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
603382|NCT00515437|O4|Outcome|Placebo|Placebo
603383|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
603384|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
603385|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
603386|NCT00515437|O4|Outcome|Placebo|Placebo
603387|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
603388|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
603389|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
603390|NCT00515437|E4|Reported Event|Placebo|Placebo
603391|NCT00515437|E3|Reported Event|3500U Myobloc|3500U Myobloc
603392|NCT00515437|E2|Reported Event|2500U Myobloc|2500U Myobloc
603393|NCT00515437|E1|Reported Event|1500U Myobloc|1500U Myobloc
603394|NCT00515294|B5|Baseline|Total|Total of all reporting groups
603395|NCT00515294|B4|Baseline|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
603396|NCT00515294|B3|Baseline|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
603397|NCT00515294|B2|Baseline|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
603398|NCT00515294|B1|Baseline|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
603399|NCT00515294|P4|Participant Flow|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
603400|NCT00515294|P3|Participant Flow|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
603401|NCT00515294|P2|Participant Flow|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
603402|NCT00515294|P1|Participant Flow|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
603403|NCT00515294|O4|Outcome|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
603404|NCT00515294|O3|Outcome|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
603405|NCT00515294|O2|Outcome|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
603406|NCT00515294|O1|Outcome|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
603407|NCT00515294|O4|Outcome|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
603408|NCT00515294|O3|Outcome|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
603409|NCT00515294|O2|Outcome|2Non-Caffeinated Alcoholic Beer|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
603410|NCT00515294|O1|Outcome|1Caffeinated Alcoholic Beer|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
603411|NCT00515294|E4|Reported Event|4Non-Alcoholic, Non-Caffeinated Beer|Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
603412|NCT00515294|E3|Reported Event|3Caffeinated Non-Alcoholic Beer|Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.
603413|NCT00515294|E2|Reported Event|2Non-Caffeinated Alcohol|Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer
603414|NCT00515294|E1|Reported Event|1Caffeinated Alcohol|Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.
603415|NCT00515216|B1|Baseline|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603416|NCT00515216|P1|Participant Flow|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
603417|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603418|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603419|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603420|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603421|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603422|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603423|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603424|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603425|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603426|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603427|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603428|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603429|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603430|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603431|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
603432|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603433|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603434|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603435|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603436|NCT00515216|E1|Reported Event|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
603437|NCT00515203|B3|Baseline|Total|Total of all reporting groups
603439|NCT00515203|B1|Baseline|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603440|NCT00515203|P2|Participant Flow|Placebo|Placebo by subcutaneous injection once weekly
603441|NCT00515203|P1|Participant Flow|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603442|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
603443|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603444|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
603445|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603446|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
603447|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603448|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
603449|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603450|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
603451|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603452|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
603453|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
603454|NCT00515203|E2|Reported Event|Romiplostim|
603455|NCT00515203|E1|Reported Event|Placebo|
603456|NCT00515177|B3|Baseline|Total|Total of all reporting groups
603457|NCT00515177|B2|Baseline|Randomized to PCT|
603458|NCT00515177|B1|Baseline|Randomized to MBSR|
603459|NCT00515177|P2|Participant Flow|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
603460|NCT00515177|P1|Participant Flow|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
603461|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
603462|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
603463|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
603464|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
603465|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
603466|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
603467|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
603468|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
603469|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use."
603470|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
603471|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
603472|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
603473|NCT00515177|E2|Reported Event|MBSR|Mindfulness-Based Stress Reduction (MBSR) is an 8 week program of yoga and mindfulness training taught by a trained instructor in a group format.
603474|NCT00515177|E1|Reported Event|Pharmacotherapy (Eszopiclone, 3mg)|The PCT control treatment consisted of 3mg eszopiclone nightly for 8 weeks, followed by use as needed for 3 months.
603475|NCT00515112|B3|Baseline|Total|Total of all reporting groups
603476|NCT00515112|B2|Baseline|Placebo|"Three subjects received the placebo~Placebo: placebo"
603477|NCT00515112|B1|Baseline|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
603478|NCT00515112|P2|Participant Flow|Placebo|"Three subjects received the placebo~Placebo: placebo"
603479|NCT00515112|P1|Participant Flow|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
603480|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo~Placebo: placebo"
603481|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
603482|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo~Placebo: placebo"
603483|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
603484|NCT00515112|E2|Reported Event|Placebo|"Three subjects received the placebo~Placebo: placebo"
603485|NCT00515112|E1|Reported Event|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
603486|NCT00515099|B3|Baseline|Total|Total of all reporting groups
603487|NCT00515099|B2|Baseline|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603488|NCT00515099|B1|Baseline|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603489|NCT00515099|P2|Participant Flow|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603490|NCT00515099|P1|Participant Flow|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603491|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603492|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603493|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603494|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603495|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603496|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603497|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603498|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603499|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603752|NCT00514813|P4|Participant Flow|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
603500|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603501|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603502|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603503|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603504|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
603505|NCT00515099|E2|Reported Event|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
603506|NCT00515099|E1|Reported Event|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
603507|NCT00515086|B5|Baseline|Total|Total of all reporting groups
603508|NCT00515086|B4|Baseline|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603509|NCT00515086|B3|Baseline|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603510|NCT00515086|B2|Baseline|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603511|NCT00515086|B1|Baseline|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
603512|NCT00515086|P4|Participant Flow|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603513|NCT00515086|P3|Participant Flow|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603514|NCT00515086|P2|Participant Flow|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603515|NCT00515086|P1|Participant Flow|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
603516|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603517|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603518|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603519|NCT00515086|O3|Outcome|Total : No Surgery|Total participants enrolled with recurrent glioblastoma multiforme (GBM) who were not scheduled to undergo a planned salvage surgical resection. All participants in this arm were to receive a fixed daily dose of 10 mg/day oral everolimus.
603520|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme (GBM) with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
603521|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
603522|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603523|NCT00515086|O2|Outcome|Everolimus 5mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603524|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603525|NCT00515086|O4|Outcome|Total|All the participants scheduled to undergo salvage surgical resection from three pre-surgery treatment groups (i.e 0, 5 or 10 mg/day (once daily) everolimus X 7 days).
603526|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603527|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603528|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603529|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603530|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603531|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603532|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
603533|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
603534|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603535|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603536|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603537|NCT00515086|E4|Reported Event|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
603538|NCT00515086|E3|Reported Event|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603539|NCT00515086|E2|Reported Event|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603540|NCT00515086|E1|Reported Event|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
603541|NCT00515073|B1|Baseline|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
603542|NCT00515073|P1|Participant Flow|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
603543|NCT00515073|O1|Outcome|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
603544|NCT00515073|E1|Reported Event|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
603545|NCT00515034|B5|Baseline|Total|Total of all reporting groups
603546|NCT00515034|B4|Baseline|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603547|NCT00515034|B3|Baseline|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603548|NCT00515034|B2|Baseline|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
603549|NCT00515034|B1|Baseline|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
603550|NCT00515034|P4|Participant Flow|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603551|NCT00515034|P3|Participant Flow|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603552|NCT00515034|P2|Participant Flow|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
603553|NCT00515034|P1|Participant Flow|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
603554|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603555|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603556|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
603557|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
603558|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603559|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603560|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
603561|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
603562|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603563|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603564|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
603565|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
603566|NCT00515034|E4|Reported Event|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603567|NCT00515034|E3|Reported Event|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
603568|NCT00515034|E2|Reported Event|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
603569|NCT00515034|E1|Reported Event|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
603570|NCT00515008|B3|Baseline|Total|Total of all reporting groups
603571|NCT00515008|B2|Baseline|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603572|NCT00515008|B1|Baseline|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603573|NCT00515008|P2|Participant Flow|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program. Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks. At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management. For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
603704|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603574|NCT00515008|P1|Participant Flow|Tai Chi Group|12-week Tai Chi Program.: The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
603575|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603576|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603577|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603578|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603579|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603580|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603581|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603582|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603583|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603584|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603585|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603586|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603587|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
603588|NCT00515008|O1|Outcome|Tai Chi|The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
603589|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
603590|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai~chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
603591|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
603619|NCT00514943|O1|Outcome|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603620|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603592|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai~chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
603593|NCT00515008|E2|Reported Event|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
603594|NCT00515008|E1|Reported Event|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
603595|NCT00514943|B3|Baseline|Total|Total of all reporting groups
603596|NCT00514943|B2|Baseline|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603597|NCT00514943|B1|Baseline|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603598|NCT00514943|P2|Participant Flow|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603599|NCT00514943|P1|Participant Flow|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603600|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603601|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
603602|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
603603|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603604|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
603605|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
603606|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603607|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
603608|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603609|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603610|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
603611|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
603612|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603613|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603614|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
603615|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
603616|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
603617|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
603618|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603703|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603621|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603622|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603623|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603624|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603625|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603626|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603627|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603628|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603629|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603630|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603631|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603632|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603633|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603634|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603635|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603636|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603637|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603638|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603639|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
603640|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603641|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603642|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603643|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603644|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603645|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603646|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603647|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
603648|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
603649|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
603746|NCT00514852|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603650|NCT00514943|E4|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 1|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603651|NCT00514943|E3|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
603652|NCT00514943|E2|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
603653|NCT00514943|E1|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
603654|NCT00514917|B3|Baseline|Total|Total of all reporting groups
603655|NCT00514917|B2|Baseline|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603656|NCT00514917|B1|Baseline|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603657|NCT00514917|P2|Participant Flow|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603658|NCT00514917|P1|Participant Flow|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603659|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603660|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603661|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603662|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603663|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603664|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603665|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603666|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603667|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603668|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603669|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603670|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603671|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603672|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603673|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603747|NCT00514813|B5|Baseline|Total|Total of all reporting groups
603674|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603675|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603676|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603677|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg/m^2 subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603678|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles along with leuprolide 22.5 mg/m^2subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603679|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603680|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603681|NCT00514917|E2|Reported Event|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603682|NCT00514917|E1|Reported Event|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
603683|NCT00514904|B3|Baseline|Total|Total of all reporting groups
603684|NCT00514904|B2|Baseline|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603685|NCT00514904|B1|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603686|NCT00514904|P2|Participant Flow|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603687|NCT00514904|P1|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603688|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603689|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603690|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603691|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603692|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603693|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603694|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603695|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603696|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603697|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603698|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603699|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603700|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603701|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603702|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603748|NCT00514813|B4|Baseline|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
603705|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603706|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603707|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603708|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603709|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603710|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603711|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603712|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603713|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603714|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603715|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603716|NCT00514904|O2|Outcome|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603717|NCT00514904|O1|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603718|NCT00514904|E2|Reported Event|Mencevax ACWY Group|Subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.
603719|NCT00514904|E1|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0. Nimenrix™ vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
603720|NCT00514852|B3|Baseline|Total|Total of all reporting groups
603721|NCT00514852|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603722|NCT00514852|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603723|NCT00514852|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603724|NCT00514852|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603725|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603726|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603727|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603728|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603729|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603730|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603731|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603732|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603733|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603734|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603735|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603736|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603737|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603738|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603739|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603740|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603741|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603742|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603743|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603744|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603745|NCT00514852|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
603753|NCT00514813|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
603754|NCT00514813|P2|Participant Flow|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
603755|NCT00514813|P1|Participant Flow|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
603756|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
603757|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
603758|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
603759|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
603760|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
603761|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
603762|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
603763|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
603764|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
603765|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
603766|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
603767|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
603768|NCT00514813|E4|Reported Event|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
603769|NCT00514813|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
603770|NCT00514813|E2|Reported Event|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
603771|NCT00514813|E1|Reported Event|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
603772|NCT00514735|B3|Baseline|Total|Total of all reporting groups
603773|NCT00514735|B2|Baseline|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603774|NCT00514735|B1|Baseline|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603775|NCT00514735|P2|Participant Flow|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603776|NCT00514735|P1|Participant Flow|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603777|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603778|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603779|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603829|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603830|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603780|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603781|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603782|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603783|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603784|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603785|NCT00514735|O1|Outcome|Ablation Management|
603786|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603787|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603788|NCT00514735|O1|Outcome|Ablation Management|
603789|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603790|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603791|NCT00514735|E2|Reported Event|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
603831|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603832|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603833|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603792|NCT00514735|E1|Reported Event|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
603793|NCT00514709|B3|Baseline|Total|Total of all reporting groups
603794|NCT00514709|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603795|NCT00514709|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603796|NCT00514709|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
603797|NCT00514709|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
603798|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603799|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603800|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603801|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP-T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603802|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603803|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603804|NCT00514709|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603805|NCT00514709|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
603806|NCT00514683|B6|Baseline|Total|Total of all reporting groups
603807|NCT00514683|B5|Baseline|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603808|NCT00514683|B4|Baseline|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603809|NCT00514683|B3|Baseline|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603810|NCT00514683|B2|Baseline|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603811|NCT00514683|B1|Baseline|Placebo|Patients were treated with matching Placebo.
603812|NCT00514683|P5|Participant Flow|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603813|NCT00514683|P4|Participant Flow|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603814|NCT00514683|P3|Participant Flow|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603815|NCT00514683|P2|Participant Flow|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603816|NCT00514683|P1|Participant Flow|Placebo|Patients were treated with matching Placebo.
603817|NCT00514683|O4|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603818|NCT00514683|O3|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603819|NCT00514683|O2|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603820|NCT00514683|O1|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603821|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603822|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603823|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603824|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603825|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603826|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603827|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603828|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603838|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603839|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603840|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603841|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603842|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603843|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603844|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603845|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603846|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603847|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603848|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603849|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603850|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603851|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603852|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603853|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603854|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603855|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603856|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603857|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603858|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603859|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603860|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603861|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603862|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603863|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603864|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603865|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603866|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603867|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603868|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603869|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603870|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603871|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603872|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603873|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603874|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603875|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603876|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603877|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603878|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603879|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603880|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603881|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603882|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603883|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603884|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603885|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603886|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603887|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603888|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603889|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603890|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603891|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603892|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603893|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603894|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603895|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603896|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603897|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603898|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603899|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603900|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603901|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603902|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603903|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603904|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603905|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603906|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603907|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603908|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603909|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603910|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603911|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603912|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603913|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603914|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603915|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603916|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603917|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603918|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603919|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603920|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603921|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603922|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603923|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603924|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603925|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603926|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603927|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603928|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603929|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603930|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603931|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603932|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603933|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603934|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603935|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603936|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603937|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603938|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603939|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603940|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603941|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603942|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603943|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603944|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603945|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603946|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603947|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603948|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603949|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603950|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603951|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603952|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603953|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603954|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603955|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603956|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603957|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603958|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603959|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603960|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603961|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603962|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603963|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603964|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603965|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603966|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603967|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603968|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603969|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603970|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603971|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603972|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603973|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603974|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603975|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603976|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603977|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603978|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603979|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603980|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603981|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603982|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603983|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603984|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603985|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603986|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603987|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603988|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603989|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603990|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603991|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603992|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603993|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603994|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
603995|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
603996|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
603997|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
603998|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
603999|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
604000|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
604001|NCT00514683|E5|Reported Event|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
604002|NCT00514683|E4|Reported Event|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
604003|NCT00514683|E3|Reported Event|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
604004|NCT00514683|E2|Reported Event|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
604005|NCT00514683|E1|Reported Event|Placebo|Patients were treated with matching Placebo.
604006|NCT00514592|B1|Baseline|All Patients|All patients are in the same group
604007|NCT00514592|P1|Participant Flow|All Patients|All patients enter the same group
604008|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
604009|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
604010|NCT00514592|E1|Reported Event|All Patients|All patients enter the same group
604011|NCT00514514|B4|Baseline|Total|Total of all reporting groups
604012|NCT00514514|B3|Baseline|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604013|NCT00514514|B2|Baseline|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604014|NCT00514514|B1|Baseline|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604015|NCT00514514|P3|Participant Flow|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604016|NCT00514514|P2|Participant Flow|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604017|NCT00514514|P1|Participant Flow|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604018|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604019|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604020|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604021|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604022|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604023|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604024|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604025|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604026|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604027|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604028|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604029|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604030|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604031|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604032|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604033|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604034|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604035|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604036|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604037|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604038|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604039|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604040|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604041|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604042|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604043|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604044|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604045|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604046|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604047|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604048|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604049|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604050|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604051|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604052|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604053|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604054|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604055|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
604056|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604057|NCT00514514|E3|Reported Event|CNI-low|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
604058|NCT00514514|E2|Reported Event|CNI-free|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids"
604059|NCT00514514|E1|Reported Event|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
604060|NCT00514501|B1|Baseline|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
604061|NCT00514501|P1|Participant Flow|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
604062|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
604063|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
604064|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
604065|NCT00514501|E1|Reported Event|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
604066|NCT00514449|B3|Baseline|Total|Total of all reporting groups
604067|NCT00514449|B2|Baseline|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
604068|NCT00514449|B1|Baseline|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
604069|NCT00514449|P2|Participant Flow|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
604070|NCT00514449|P1|Participant Flow|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
604071|NCT00514449|O2|Outcome|Sugar Pill|A time by treatment group interaction showed decreased or no significant change in the gray matter volume estimated as number of voxels in a cluster with Valaclcovir compared to placebo
604072|NCT00514449|O1|Outcome|Valacyclovir|A time by treatment group interaction showed increased gray matter volume estimated as number of voxels in a cluster with Valaclcovir compared to placebo
604073|NCT00514449|O2|Outcome|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
604074|NCT00514449|O1|Outcome|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
604075|NCT00514449|O2|Outcome|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
604076|NCT00514449|O1|Outcome|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks
604077|NCT00514449|E2|Reported Event|Sugar Pill|2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
604078|NCT00514449|E1|Reported Event|Valacyclovir|1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
604079|NCT00514215|B1|Baseline|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
604080|NCT00514215|P1|Participant Flow|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
604081|NCT00514215|O1|Outcome|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
604082|NCT00514215|E1|Reported Event|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
604083|NCT00514137|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
604084|NCT00514137|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
604085|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
604086|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
604087|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
604088|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
604089|NCT00514137|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
604090|NCT00514020|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
604091|NCT00514020|P1|Participant Flow|5-FU, Leucovorin, Oxaliplatin|"Patients who have TSER*2/*2 or TSER*2/*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER*3 will not be included in study.~FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.~Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment."
604092|NCT00514020|O1|Outcome|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
604093|NCT00514020|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
604094|NCT00513799|B5|Baseline|Total|Total of all reporting groups
604095|NCT00513799|B4|Baseline|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
604096|NCT00513799|B3|Baseline|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
604097|NCT00513799|B2|Baseline|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
604098|NCT00513799|B1|Baseline|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
604099|NCT00513799|P4|Participant Flow|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
604100|NCT00513799|P3|Participant Flow|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
604101|NCT00513799|P2|Participant Flow|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
604102|NCT00513799|P1|Participant Flow|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
604103|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604104|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604261|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604105|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604106|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604107|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604108|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604109|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604110|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
604111|NCT00513799|O4|Outcome|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
604112|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
604113|NCT00513799|O2|Outcome|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
604114|NCT00513799|O1|Outcome|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
604115|NCT00513799|E4|Reported Event|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
604116|NCT00513799|E3|Reported Event|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
604117|NCT00513799|E2|Reported Event|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
604118|NCT00513799|E1|Reported Event|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
604119|NCT00513708|B4|Baseline|Total|Total of all reporting groups
604120|NCT00513708|B3|Baseline|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
604121|NCT00513708|B2|Baseline|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
604122|NCT00513708|B1|Baseline|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
604123|NCT00513708|P3|Participant Flow|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
604124|NCT00513708|P2|Participant Flow|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
604125|NCT00513708|P1|Participant Flow|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
604235|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
604126|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
604127|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
604128|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
604129|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
604130|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
604131|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
604132|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
604133|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
604134|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
604135|NCT00513708|E3|Reported Event|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
604136|NCT00513708|E2|Reported Event|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
604137|NCT00513708|E1|Reported Event|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
604138|NCT00513695|B1|Baseline|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604139|NCT00513695|P1|Participant Flow|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604140|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604151|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
604307|NCT00513357|P1|Participant Flow|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
604141|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604142|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604143|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604144|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604145|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604146|NCT00513695|E1|Reported Event|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
604147|NCT00513682|B1|Baseline|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
604148|NCT00513682|P1|Participant Flow|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
604149|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
604150|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
604152|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
604153|NCT00513682|E3|Reported Event|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
604154|NCT00513682|E2|Reported Event|Ultrase® MT20 Washout Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent a washout phase, of 6 to 7 days, in which participants received only high-fat diet and refrained from taking Ultrase® MT20.
604155|NCT00513682|E1|Reported Event|Ultrase® MT20 Screening Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea.
604156|NCT00513617|B4|Baseline|Total|Total of all reporting groups
604157|NCT00513617|B3|Baseline|Placebo|
604158|NCT00513617|B2|Baseline|High Dose|0.10 g/kg/day of Arginine in capsule form
604159|NCT00513617|B1|Baseline|Low Dose|0.05 g/kg/day of Arginine in capsule form
604160|NCT00513617|P3|Participant Flow|Placebo|
604161|NCT00513617|P2|Participant Flow|High Dose|0.10 g/kg/day of Arginine in capsule form
604162|NCT00513617|P1|Participant Flow|Low Dose|0.05 g/kg/day of Arginine in capsule form
604163|NCT00513617|O3|Outcome|Placebo|
604164|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
604165|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
604166|NCT00513617|O3|Outcome|Placebo|
604167|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
604168|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
604169|NCT00513617|O3|Outcome|Placebo|
604170|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
604171|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
604172|NCT00513604|B6|Baseline|Total|Total of all reporting groups
604173|NCT00513604|B5|Baseline|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
604174|NCT00513604|B4|Baseline|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604175|NCT00513604|B3|Baseline|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604176|NCT00513604|B2|Baseline|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604177|NCT00513604|B1|Baseline|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604178|NCT00513604|P5|Participant Flow|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
604179|NCT00513604|P4|Participant Flow|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604218|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
604180|NCT00513604|P3|Participant Flow|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604181|NCT00513604|P2|Participant Flow|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604182|NCT00513604|P1|Participant Flow|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604183|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
604184|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604185|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604186|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604187|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604188|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
604189|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604190|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604191|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604308|NCT00513357|O2|Outcome|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
604192|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604193|NCT00513604|E5|Reported Event|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
604194|NCT00513604|E4|Reported Event|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604195|NCT00513604|E3|Reported Event|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604196|NCT00513604|E2|Reported Event|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604197|NCT00513604|E1|Reported Event|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
604198|NCT00513526|B1|Baseline|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
604199|NCT00513526|P1|Participant Flow|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
604200|NCT00513526|O1|Outcome|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
604201|NCT00513526|O1|Outcome|Gardasil|
604202|NCT00513526|O1|Outcome|Gardasil|
604203|NCT00513526|O1|Outcome|Gardasil|
604204|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
604205|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
604206|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
604207|NCT00513526|O1|Outcome|Gardasil|
604208|NCT00513526|O1|Outcome|Gardasil|
604209|NCT00513526|O1|Outcome|Gardasil|
604210|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
604211|NCT00513526|O1|Outcome|Gardasil|
604212|NCT00513526|E1|Reported Event|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
604213|NCT00513500|B3|Baseline|Total|Total of all reporting groups
604214|NCT00513500|B2|Baseline|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
604215|NCT00513500|B1|Baseline|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
604216|NCT00513500|P2|Participant Flow|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
604217|NCT00513500|P1|Participant Flow|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
604260|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604219|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
604220|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
604221|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
604222|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
604223|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
604224|NCT00513500|E2|Reported Event|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
604225|NCT00513500|E1|Reported Event|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
604226|NCT00513474|B3|Baseline|Total|Total of all reporting groups
604227|NCT00513474|B2|Baseline|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
604228|NCT00513474|B1|Baseline|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
604229|NCT00513474|P2|Participant Flow|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
604230|NCT00513474|P1|Participant Flow|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
604231|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
604232|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
604233|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
604234|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
612301|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
604236|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
604237|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
604238|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
604239|NCT00513474|E2|Reported Event|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
604240|NCT00513474|E1|Reported Event|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
604241|NCT00513435|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
604242|NCT00513435|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
604243|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
604244|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
604245|NCT00513435|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
604246|NCT00513409|B3|Baseline|Total|Total of all reporting groups
604247|NCT00513409|B2|Baseline|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604248|NCT00513409|B1|Baseline|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604249|NCT00513409|P2|Participant Flow|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604250|NCT00513409|P1|Participant Flow|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604251|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604252|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604253|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604254|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604255|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604256|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604257|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604258|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604259|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604309|NCT00513357|O1|Outcome|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
604262|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604263|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604264|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604265|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604266|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604267|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604268|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604269|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604270|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604271|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604272|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604273|NCT00513409|E2|Reported Event|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604274|NCT00513409|E1|Reported Event|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
604275|NCT00513370|B1|Baseline|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
604276|NCT00513370|P1|Participant Flow|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
604277|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604278|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604279|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604280|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604281|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604282|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604283|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604284|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604285|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604286|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604287|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604288|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604289|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604290|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604291|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604292|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604293|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604294|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604295|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604296|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604297|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604298|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604299|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
604300|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604301|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
604302|NCT00513370|E1|Reported Event|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
604303|NCT00513357|B3|Baseline|Total|Total of all reporting groups
604304|NCT00513357|B2|Baseline|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
604305|NCT00513357|B1|Baseline|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
604306|NCT00513357|P2|Participant Flow|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
604310|NCT00513357|E2|Reported Event|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
604311|NCT00513357|E1|Reported Event|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
604312|NCT00513344|B1|Baseline|Entire Study Population|Includes groups randomized to receive control first, milk chocolate first, and dark chocolate first
604313|NCT00513344|P1|Participant Flow|Each Subject Tested the Three Products Randomly Following|"Before the 1st intervention, no food with polyphenols was admitted~Each subject was administered the three products randomly(one product per one-day intervention) according to the six possible sequencies:~Either dark chocolate first, then milk chocolate then control~or dark chocolate first, then control, then milk chocolate~or control first, then dark chocolate, then milk chocolate~or Control first, then milk chocolate, then dark chocolate~or Milk chocolate first, then control, then dark chocolate~or milk chocolate first, then dark chocolate, then control r dark chocolate was given once in the morning (1 day) Products were administered in the morning of the testing day. The testing days (interventions) were separated by a three-day wash-out period."
604314|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate~Dark Chocolate : 1 portion"
604315|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate~Milk Chocolate : 1 portion"
604316|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate~Control (polyphenol-free)"
604317|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate~Dark Chocolate : 1 portion"
604318|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate~Milk Chocolate : 1 portion"
604319|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate~Control (polyphenol-free)"
604320|NCT00513344|E3|Reported Event|Control|
604321|NCT00513344|E2|Reported Event|Milk Chocolate|
604322|NCT00513344|E1|Reported Event|Dark Chocolate|
604323|NCT00513305|B3|Baseline|Total|Total of all reporting groups
604324|NCT00513305|B2|Baseline|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604325|NCT00513305|B1|Baseline|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604326|NCT00513305|P2|Participant Flow|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604327|NCT00513305|P1|Participant Flow|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604328|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604717|NCT00511706|E2|Reported Event|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
604329|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604330|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604331|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604332|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604333|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604334|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604335|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604365|NCT00513240|P1|Participant Flow|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
604366|NCT00513240|O3|Outcome|Placebo|Placebo
604336|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604337|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604338|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604339|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604340|NCT00513305|E2|Reported Event|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
604341|NCT00513305|E1|Reported Event|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
604342|NCT00513292|B3|Baseline|Total|Total of all reporting groups
604343|NCT00513292|B2|Baseline|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604367|NCT00513240|O2|Outcome|EPO 500 Units/kg QODx3|Revised dose after FDA clinical hold removed of EPO 500 units/kg every other day for 3 doses
604368|NCT00513240|O1|Outcome|EPO 1000 Units/kg QDx3|Original dose of 1000 units/kg every day for 3 doses
604399|NCT00512876|P1|Participant Flow|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
604720|NCT00511667|B2|Baseline|Placebo|All participants receiving any dose of placebo
604344|NCT00513292|B1|Baseline|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604345|NCT00513292|P2|Participant Flow|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604346|NCT00513292|P1|Participant Flow|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604347|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604348|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604349|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604350|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604351|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604352|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604369|NCT00513240|E2|Reported Event|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
604721|NCT00511667|B1|Baseline|MK-0941|All participants receiving any dose of MK-0941
604353|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604354|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604355|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604356|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604357|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604358|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604359|NCT00513292|E2|Reported Event|Arm B|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604360|NCT00513292|E1|Reported Event|Arm A|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
604361|NCT00513240|B3|Baseline|Total|Total of all reporting groups
604362|NCT00513240|B2|Baseline|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
604363|NCT00513240|B1|Baseline|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
604364|NCT00513240|P2|Participant Flow|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
604555|NCT00511862|B1|Baseline|Colorectal Cancer|colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy
604370|NCT00513240|E1|Reported Event|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
604371|NCT00513071|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604372|NCT00513071|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604373|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604374|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604375|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604376|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604377|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604378|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604379|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604380|NCT00513071|E1|Reported Event|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
604381|NCT00513019|B3|Baseline|Total|Total of all reporting groups
604382|NCT00513019|B2|Baseline|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
604383|NCT00513019|B1|Baseline|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
604384|NCT00513019|P2|Participant Flow|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
604385|NCT00513019|P1|Participant Flow|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
604386|NCT00513019|O2|Outcome|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
604387|NCT00513019|O1|Outcome|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
604388|NCT00513019|E2|Reported Event|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
604389|NCT00513019|E1|Reported Event|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
604390|NCT00512902|B1|Baseline|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604391|NCT00512902|P1|Participant Flow|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604392|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604393|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604394|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604395|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604396|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604397|NCT00512902|E1|Reported Event|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
604398|NCT00512876|B1|Baseline|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
604400|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
604401|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
604402|NCT00512876|E1|Reported Event|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye
604403|NCT00512798|B3|Baseline|Total|Total of all reporting groups
604404|NCT00512798|B2|Baseline|Phase II|
604405|NCT00512798|B1|Baseline|Phase I|
604406|NCT00512798|P2|Participant Flow|Phase II|PS-341 and Temozolomide will be administered in the same manner as in Phase I at doses as determined by the Phase I portion of the trial.
604407|NCT00512798|P1|Participant Flow|Phase I|PS-341 will be administered intravenously at 1.0 mg/m2 of body weight beginning on days 1, 4, 8, and 11 of every 21 days. If toxicity occurs, dose will be lowered to 0.7 mg/m2. Dose can be raised to a maximum of 1.5 mg/m2. Temozolomide will be orally administered daily at 50 mg/m2 of body weight beginning on day 8 for 6 weeks of every 9-week cycle, followed by a 3-week rest. Minimum dose is 50 mg/m2 and maximum dose is 75 mg/m2.
604408|NCT00512798|O1|Outcome|Phase II|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior treatment with Dacarbazine or Temozolomide with treatment failure.
604409|NCT00512798|O1|Outcome|Phase II|Phase II patients who were available for blood draw on the designated days.
604410|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
604411|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
604412|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
604413|NCT00512798|E2|Reported Event|Phase II|
604414|NCT00512798|E1|Reported Event|Phase I|
604415|NCT00512707|B3|Baseline|Total|Total of all reporting groups
604416|NCT00512707|B2|Baseline|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604417|NCT00512707|B1|Baseline|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604418|NCT00512707|P2|Participant Flow|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604419|NCT00512707|P1|Participant Flow|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604420|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604430|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604718|NCT00511706|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
604421|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604422|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604423|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604424|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604425|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604426|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604427|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604428|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604429|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604431|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604432|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604433|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604434|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604435|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604436|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604437|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604438|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604439|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604440|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604441|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604442|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604443|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604444|NCT00512707|O2|Outcome|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604445|NCT00512707|O1|Outcome|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604446|NCT00512707|E2|Reported Event|Placebo|"Placebo Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day."
604447|NCT00512707|E1|Reported Event|Testosterone|"Active Testosterone Gel~Sildenafil citrate (open label): On demand use of sildenafil citrate (3 tablets per week). Starting dose of 50 mg. Titrated to 100 mg or 25 mg depending on efficacy and tolerability. Begins as open label run in period for 3 - 6 weeks, and continues during the placebo-controlled testosterone gel intervention for 16 weeks.~Testosterone gel 1% (active or placebo): Testosterone Gel 1%: Starting active dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.~Topical testosterone gel 1%: Testosterone Gel: Starting dose 10 g/day. Increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinded achieved by combining a total of 3 tubes of active or placebo gel."
604448|NCT00512278|B3|Baseline|Total|Total of all reporting groups
604449|NCT00512278|B2|Baseline|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study"
604450|NCT00512278|B1|Baseline|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604593|NCT00511810|E2|Reported Event|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
604451|NCT00512278|P2|Participant Flow|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study"
604452|NCT00512278|P1|Participant Flow|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604453|NCT00512278|O2|Outcome|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study"
604454|NCT00512278|O1|Outcome|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604455|NCT00512278|O2|Outcome|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study"
604456|NCT00512278|O1|Outcome|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604457|NCT00512278|O2|Outcome|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study"
604458|NCT00512278|O1|Outcome|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604459|NCT00512278|O2|Outcome|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study"
604460|NCT00512278|O1|Outcome|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604461|NCT00512278|O2|Outcome|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study"
604462|NCT00512278|O1|Outcome|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604463|NCT00512278|E2|Reported Event|B Placebo|"Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV~Placebo : Placebo~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study"
604464|NCT00512278|E1|Reported Event|A Infliximab|"Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab~Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46~All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses"
604465|NCT00512252|B4|Baseline|Total|Total of all reporting groups
604466|NCT00512252|B3|Baseline|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
604467|NCT00512252|B2|Baseline|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
604468|NCT00512252|B1|Baseline|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
604469|NCT00512252|P3|Participant Flow|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
604470|NCT00512252|P2|Participant Flow|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
604471|NCT00512252|P1|Participant Flow|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
604472|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
604473|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
604474|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
604475|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
604476|NCT00512252|O2|Outcome|Primary Refractory|
604477|NCT00512252|O1|Outcome|First Relapse, First Salvage|
604478|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
604479|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
604480|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
604481|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
604482|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
604483|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
604484|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
604485|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
604486|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
604487|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
604488|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
604489|NCT00512252|O1|Outcome|Phase I Dose Escalation/Phase II Dose Treatment|
604490|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
604491|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
604492|NCT00512252|O2|Outcome|Primary Refractory|
604493|NCT00512252|O1|Outcome|First Relapse, First Salvage|
604494|NCT00512252|O1|Outcome|Phase I Dose Escalation|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d~Dose Level 2 AMD3100 dose = 160 mcg/kg/d~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
604495|NCT00512252|E3|Reported Event|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
604496|NCT00512252|E2|Reported Event|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
604497|NCT00512252|E1|Reported Event|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
604498|NCT00512148|B1|Baseline|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
604499|NCT00512148|P1|Participant Flow|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
604500|NCT00512148|O1|Outcome|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
604501|NCT00512148|O1|Outcome|All Implanted|The number of subjects implanted with the neobladder augment
604502|NCT00512148|E1|Reported Event|Safety Population|Patients who underwent screening procedures and met inclusion/exclusion criteria.
604503|NCT00512096|B1|Baseline|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
604504|NCT00512096|P1|Participant Flow|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
604505|NCT00512096|O1|Outcome|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
604506|NCT00512096|E1|Reported Event|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
604507|NCT00511992|B1|Baseline|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
604508|NCT00511992|P1|Participant Flow|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
604509|NCT00511992|O1|Outcome|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
604510|NCT00511992|O1|Outcome|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
604553|NCT00511862|B3|Baseline|Non-Colorectal/Non-neuroendocrine|patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy
604511|NCT00511992|E1|Reported Event|Avastin|"Avastin: Initial Treatment:~Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)~Consolidation Treatment:~Avastin 15mg/kg IV every 21 days x 12 cycles"
604512|NCT00511914|B3|Baseline|Total|Total of all reporting groups
604513|NCT00511914|B2|Baseline|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604514|NCT00511914|B1|Baseline|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604515|NCT00511914|P2|Participant Flow|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604516|NCT00511914|P1|Participant Flow|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604517|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604518|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604519|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604520|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604521|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604522|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604523|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604524|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604525|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604526|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604527|NCT00511914|E2|Reported Event|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604528|NCT00511914|E1|Reported Event|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
604529|NCT00511901|B3|Baseline|Total|Total of all reporting groups
604530|NCT00511901|B2|Baseline|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604531|NCT00511901|B1|Baseline|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604532|NCT00511901|P2|Participant Flow|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604533|NCT00511901|P1|Participant Flow|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604534|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604535|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604536|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604537|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604538|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604539|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604540|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604541|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604542|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604543|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604544|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604545|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604546|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604547|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604548|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604549|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604550|NCT00511901|E2|Reported Event|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604551|NCT00511901|E1|Reported Event|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
604552|NCT00511862|B4|Baseline|Total|Total of all reporting groups
604554|NCT00511862|B2|Baseline|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
604556|NCT00511862|P3|Participant Flow|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604557|NCT00511862|P2|Participant Flow|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604558|NCT00511862|P1|Participant Flow|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604559|NCT00511862|O1|Outcome|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
604560|NCT00511862|O3|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
604561|NCT00511862|O2|Outcome|Non Colorectal/Non-Neuroendocrine|Patients with metastatic liver disease arising from primary cancers other than colorectal or neuroendocrine cancer who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604562|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604563|NCT00511862|O4|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
604564|NCT00511862|O3|Outcome|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604565|NCT00511862|O2|Outcome|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604566|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
604567|NCT00511862|E1|Reported Event|TheraSphere|total population receiving at least one TheraSphere treatment
604568|NCT00511836|B3|Baseline|Total|Total of all reporting groups
604569|NCT00511836|B2|Baseline|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
604570|NCT00511836|B1|Baseline|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
604571|NCT00511836|P2|Participant Flow|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
604572|NCT00511836|P1|Participant Flow|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
604573|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
604574|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
604575|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
604576|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
604577|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
604578|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
604579|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
604580|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
604581|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
604582|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
604583|NCT00511836|E3|Reported Event|Optional Open-label VIVITROL Period (2 Months)|Following the 28-day, double-blind treatment period, all subjects were offered a chance to receive open-label VIVITROL for an additional 2 months (2 injections, each separated by 1 month). Safety data are described for all subjects in the VIVITROL open-label period, regardless of the treatment received (VIVITROL or placebo) for the first month.
604584|NCT00511836|E2|Reported Event|Placebo (Double-blind Period)|Placebo for VIVITROL 380 mg. Data are described for the initial 28-day double-blind period.
604585|NCT00511836|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|VIVITROL 380 mg (naltrexone for extended-release injectable suspension). Data are described for the initial 28-day double-blind period.
604586|NCT00511810|B3|Baseline|Total|Total of all reporting groups
604587|NCT00511810|B2|Baseline|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
604588|NCT00511810|B1|Baseline|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
604589|NCT00511810|P2|Participant Flow|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
604590|NCT00511810|P1|Participant Flow|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
604591|NCT00511810|O2|Outcome|Baseline CDRS-R: Low Dose Fish Oil|CDRS-R scores were computed for Low Fish Oil groups.
604592|NCT00511810|O1|Outcome|Baseline CDRS-R: High Dose Fish Oil|CDRS-R scores were computed for High Fish Oil groups.
604719|NCT00511667|B3|Baseline|Total|Total of all reporting groups
604594|NCT00511810|E1|Reported Event|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
604595|NCT00511797|B5|Baseline|Total|Total of all reporting groups
604596|NCT00511797|B4|Baseline|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604597|NCT00511797|B3|Baseline|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604598|NCT00511797|B2|Baseline|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604599|NCT00511797|B1|Baseline|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604600|NCT00511797|P4|Participant Flow|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604601|NCT00511797|P3|Participant Flow|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604602|NCT00511797|P2|Participant Flow|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604603|NCT00511797|P1|Participant Flow|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604604|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604605|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604606|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604607|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604608|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604609|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604610|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604611|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604612|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604613|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604614|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604615|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604616|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604617|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604618|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604619|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604620|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604621|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604622|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604623|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604624|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604625|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604626|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604627|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604628|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604629|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604630|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604631|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604632|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604633|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604716|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
604634|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604635|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604636|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604637|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604638|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604639|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604640|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604641|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604642|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604643|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604644|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604645|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604646|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604647|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604648|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604649|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604650|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604651|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604652|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604653|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604654|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604655|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604656|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604657|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604658|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604659|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604660|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604661|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604662|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604663|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604664|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604665|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604666|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604667|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604668|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604669|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604670|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604671|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604672|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604673|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604674|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604675|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604676|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604677|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604678|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604679|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604680|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604681|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604682|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604683|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604684|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604685|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604686|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604687|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604688|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604689|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604690|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604691|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604692|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604693|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604694|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604695|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604696|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604697|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604698|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604699|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604700|NCT00511797|E4|Reported Event|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
604701|NCT00511797|E3|Reported Event|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604702|NCT00511797|E2|Reported Event|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604703|NCT00511797|E1|Reported Event|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
604704|NCT00511706|B3|Baseline|Total|Total of all reporting groups
604705|NCT00511706|B2|Baseline|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
604706|NCT00511706|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
604707|NCT00511706|P2|Participant Flow|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
604708|NCT00511706|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
604709|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
604710|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
604711|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
604712|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
604713|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
604714|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
604715|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
604722|NCT00511667|P2|Participant Flow|Placebo|All participants receiving any dose of placebo
604723|NCT00511667|P1|Participant Flow|MK-0941|All participants receiving any dose of MK-0941
604724|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
604725|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
604726|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
604727|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
604728|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
604729|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604730|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604731|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
604732|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
604733|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
604734|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604735|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg Before Each Meal|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604736|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
604737|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
604738|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
604739|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604740|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604741|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
604742|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
604743|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
604744|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604745|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604746|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
604747|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
604748|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
604749|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604750|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
604751|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
604752|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
604753|NCT00511667|E2|Reported Event|Placebo|All participants receiving any dose of placebo
604754|NCT00511667|E1|Reported Event|MK-0941|All participants receiving any dose of MK-0941
604755|NCT00511472|B3|Baseline|Total|Total of all reporting groups
604756|NCT00511472|B2|Baseline|Placebo|Participants receiving placebo while on basal insulin.
604757|NCT00511472|B1|Baseline|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
604758|NCT00511472|P2|Participant Flow|Placebo|Participants receiving placebo while on basal insulin.
604759|NCT00511472|P1|Participant Flow|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
604760|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin
604761|NCT00511472|O1|Outcome|MK-0941|Participants receiving individualized doses of MK-0941 while on basal insulin
604762|NCT00511472|O3|Outcome|Placebo|Participants receiving placebo while on basal insulin.
604763|NCT00511472|O2|Outcome|MK-0941 (Titration Group 2)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
604764|NCT00511472|O1|Outcome|MK-0941 (Titration Group 1)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
604765|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
604766|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
604767|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
604768|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
612826|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
604769|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
604770|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
604771|NCT00511472|E4|Reported Event|Placebo Titration 2|Participants receiving placebo while on basal insulin.
604772|NCT00511472|E3|Reported Event|Placebo Titration 1|Participants receiving placebo while on basal insulin.
604773|NCT00511472|E2|Reported Event|MK-0941 Titration 2|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin.
604774|NCT00511472|E1|Reported Event|MK-0941 Titration 1|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin.
604775|NCT00511433|B3|Baseline|Total|Total of all reporting groups
604776|NCT00511433|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604777|NCT00511433|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604778|NCT00511433|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604779|NCT00511433|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604780|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604781|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604782|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604783|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604784|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604785|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604786|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604787|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604788|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604789|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604790|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604791|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604792|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604793|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604794|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
605024|NCT00511108|P4|Participant Flow|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605892|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
604795|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604796|NCT00511433|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
604797|NCT00511433|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
604798|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604799|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604800|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604801|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604802|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604803|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604804|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604805|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604806|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604807|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604808|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604809|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604810|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604811|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604812|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604813|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604814|NCT00511433|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604815|NCT00511433|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
604816|NCT00511355|B3|Baseline|Total|Total of all reporting groups
605025|NCT00511108|P3|Participant Flow|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
605420|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
604817|NCT00511355|B2|Baseline|LNG-EE|"All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day cycles"
604818|NCT00511355|B1|Baseline|NOMAC-E2|All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles
604819|NCT00511355|P2|Participant Flow|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604820|NCT00511355|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604821|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604822|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604823|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604824|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604825|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
604826|NCT00511355|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
604827|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604828|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604829|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604830|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604831|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604832|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604833|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604834|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604835|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604836|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604837|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
605421|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
604838|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604839|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604840|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604841|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604842|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604843|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604844|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604845|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604846|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604847|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604848|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604849|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604850|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604851|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604852|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604853|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604854|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604855|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604856|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604857|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604858|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604859|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
605893|NCT00509197|O2|Outcome|Placebo|Treatment with placebo
604860|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604861|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604862|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604863|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604864|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604865|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604866|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604867|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604868|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604869|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604870|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604871|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604872|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604873|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604874|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604875|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604876|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604877|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604878|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604879|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604880|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604881|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
605894|NCT00509197|O1|Outcome|Fluticasone|Treatment with Fluticasone
604882|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604883|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604884|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604885|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604886|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604887|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604888|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604889|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604890|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604891|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604892|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604893|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604894|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604895|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604896|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604897|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604898|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604899|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604900|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604901|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604902|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604903|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
605895|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
604904|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604905|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604906|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604907|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604908|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604909|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604910|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604911|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604912|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604913|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604914|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604915|NCT00511355|E2|Reported Event|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
604916|NCT00511355|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
604917|NCT00511342|B3|Baseline|Total|Total of all reporting groups
604918|NCT00511342|B2|Baseline|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604919|NCT00511342|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604920|NCT00511342|P2|Participant Flow|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604921|NCT00511342|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604922|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604923|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604924|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604925|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
605026|NCT00511108|P2|Participant Flow|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
605896|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
604926|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604927|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604928|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604929|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604930|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604931|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604932|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604933|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604934|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604935|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604936|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604937|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604938|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604939|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604940|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604941|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604942|NCT00511342|E2|Reported Event|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604943|NCT00511342|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
604944|NCT00511329|B1|Baseline|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
604945|NCT00511329|P1|Participant Flow|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
604946|NCT00511329|O1|Outcome|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
605298|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
604947|NCT00511329|O1|Outcome|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
604948|NCT00511329|E1|Reported Event|Somatropin|somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
604949|NCT00511238|B3|Baseline|Total|Total of all reporting groups
604950|NCT00511238|B2|Baseline|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
604951|NCT00511238|B1|Baseline|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
604952|NCT00511238|P2|Participant Flow|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
604953|NCT00511238|P1|Participant Flow|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
604954|NCT00511238|O2|Outcome|Carfilzomib (A1) - Response-evaluable Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population(the primary analysis population) was defined as all patients who~had measurable disease at Baseline by either M-protein (serum and/or urine) or by quantitative serum Ig for certain patients with IgA myeloma~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or patients who discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib—irrespective of availability of baseline and post-baseline assessment"
604955|NCT00511238|O1|Outcome|Carfilzomib (A1) - Safety Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Safety population: The safety population was used for the analysis of safety data in this study. The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib. However, for some safety analyses, at least 1 laboratory, neurological, electrocardiogram, or vital sign measurement obtained subsequent to at least 1 dose of carfilzomib was required for inclusion in the analysis of a safety specific parameter. To assess change from baseline, a baseline measurement was also required."
604956|NCT00511238|O1|Outcome|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
604957|NCT00511238|O1|Outcome|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
604958|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Assessed by Independent Review Committee"
604959|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle.~Assesed by principal investigator."
604960|NCT00511238|O2|Outcome|Carfilzomib (A1) for (CBR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
604961|NCT00511238|O1|Outcome|Carfilzomib (A1) for (ORR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
604962|NCT00511238|O1|Outcome|Carfilzomib (A0) for (ORR)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
604963|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Assessed by Independent Review Committee"
604964|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle.~Assessed by principal investigator."
604965|NCT00511238|O2|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"
604966|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle~Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib."
604967|NCT00511238|E2|Reported Event|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
604968|NCT00511238|E1|Reported Event|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
604969|NCT00511199|B3|Baseline|Total|Total of all reporting groups
604970|NCT00511199|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604971|NCT00511199|B1|Baseline|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604972|NCT00511199|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604973|NCT00511199|P1|Participant Flow|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604974|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604975|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604976|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604977|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604978|NCT00511199|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
604979|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
604980|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604981|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604982|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604983|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604984|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604985|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604986|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604987|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604988|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
605027|NCT00511108|P1|Participant Flow|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
604989|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604990|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604991|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604992|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604993|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604994|NCT00511199|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
604995|NCT00511199|E1|Reported Event|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
604996|NCT00511173|B1|Baseline|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
604997|NCT00511173|P1|Participant Flow|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
604998|NCT00511173|O2|Outcome|Pharmacist Dosing|Warfarin dose based on clinician dosing
604999|NCT00511173|O1|Outcome|Algorithm Dosing|Warfarin dose based on algorithm by Sconce, et al.
605000|NCT00511173|E1|Reported Event|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
605001|NCT00511147|B1|Baseline|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
605002|NCT00511147|P1|Participant Flow|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
605003|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
605004|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
605005|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
605006|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
605007|NCT00511147|E1|Reported Event|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
605008|NCT00511134|B3|Baseline|Total|Total of all reporting groups
605009|NCT00511134|B2|Baseline|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
605010|NCT00511134|B1|Baseline|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
605011|NCT00511134|P2|Participant Flow|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
605012|NCT00511134|P1|Participant Flow|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
605013|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
605014|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
605015|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
605016|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
605017|NCT00511134|E2|Reported Event|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
605018|NCT00511134|E1|Reported Event|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
605019|NCT00511108|B5|Baseline|Total|Total of all reporting groups
605020|NCT00511108|B4|Baseline|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605021|NCT00511108|B3|Baseline|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
605022|NCT00511108|B2|Baseline|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
605023|NCT00511108|B1|Baseline|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605299|NCT00510510|E3|Reported Event|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605028|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605029|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
605030|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
605031|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605032|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605033|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
605034|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
605035|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605036|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605037|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
605038|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
605039|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605040|NCT00511108|E4|Reported Event|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605041|NCT00511108|E3|Reported Event|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
605042|NCT00511108|E2|Reported Event|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
605043|NCT00511108|E1|Reported Event|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
605044|NCT00511095|B1|Baseline|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
605045|NCT00511095|P1|Participant Flow|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
605046|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
605047|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
605048|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
605049|NCT00511095|E1|Reported Event|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
605050|NCT00511004|B4|Baseline|Total|Total of all reporting groups
605051|NCT00511004|B3|Baseline|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605052|NCT00511004|B2|Baseline|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605053|NCT00511004|B1|Baseline|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
605054|NCT00511004|P3|Participant Flow|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605055|NCT00511004|P2|Participant Flow|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605056|NCT00511004|P1|Participant Flow|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
605057|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605058|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605059|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
605060|NCT00511004|O3|Outcome|Diethylcarbamazine/Albendazole-HD2|"High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
605061|NCT00511004|O2|Outcome|Diethylcarbamazine/Albendazole- HD1|"High dose of DEC (300mg) and albendazole (800mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
605062|NCT00511004|O1|Outcome|Diethylcarbamazine/Albendazole -STD|"Standard therapy of diethylcarbamazine (DEC) (300mg) and albendazole (400mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
605063|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605064|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605065|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
605066|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605067|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605068|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
605069|NCT00511004|E3|Reported Event|High Dose Semiannual DEC/AC=LB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605070|NCT00511004|E2|Reported Event|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
605071|NCT00511004|E1|Reported Event|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
605072|NCT00510952|B3|Baseline|Total|Total of all reporting groups
605073|NCT00510952|B2|Baseline|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605074|NCT00510952|B1|Baseline|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605075|NCT00510952|P2|Participant Flow|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605076|NCT00510952|P1|Participant Flow|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605077|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605078|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605079|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605080|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605081|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605082|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605083|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605084|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605085|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605086|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605087|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605088|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605089|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605090|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605091|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605092|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605093|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605094|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605095|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605096|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605097|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605098|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605099|NCT00510952|E2|Reported Event|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
605100|NCT00510952|E1|Reported Event|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
605101|NCT00510887|B1|Baseline|VR-FND|"Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605102|NCT00510887|P1|Participant Flow|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605118|NCT00510874|P7|Participant Flow|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605422|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605103|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605104|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605105|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605106|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605107|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605108|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605109|NCT00510887|E1|Reported Event|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
605110|NCT00510874|B8|Baseline|Total|Total of all reporting groups
605111|NCT00510874|B7|Baseline|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605112|NCT00510874|B6|Baseline|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605113|NCT00510874|B5|Baseline|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605114|NCT00510874|B4|Baseline|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605115|NCT00510874|B3|Baseline|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605116|NCT00510874|B2|Baseline|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605117|NCT00510874|B1|Baseline|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605268|NCT00510692|P2|Participant Flow|Placebo|Medium chain triglycerides 2 g per day for six months.
605119|NCT00510874|P6|Participant Flow|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605120|NCT00510874|P5|Participant Flow|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605121|NCT00510874|P4|Participant Flow|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605122|NCT00510874|P3|Participant Flow|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605123|NCT00510874|P2|Participant Flow|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605124|NCT00510874|P1|Participant Flow|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605125|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605126|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605127|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605128|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605129|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605130|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605131|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605132|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605133|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605134|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605135|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605136|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605137|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605138|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605139|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605140|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605141|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605142|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605143|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605144|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605145|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605146|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605147|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605148|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605149|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605150|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605151|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605152|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605153|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605154|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605155|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605156|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605157|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605158|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605159|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605160|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605161|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605162|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605163|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605164|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605165|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605166|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605167|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605168|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605169|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605170|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605171|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605172|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605173|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605174|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605175|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605176|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605177|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605178|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605179|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605180|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605181|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605182|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605183|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605184|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605185|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605186|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605187|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605188|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605189|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605190|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605191|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605192|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605193|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605194|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605195|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605196|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605197|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605198|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605199|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605200|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605201|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605202|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605203|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605204|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605205|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605206|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605207|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605208|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605209|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605210|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605211|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605212|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605213|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605214|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605215|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605216|NCT00510874|E7|Reported Event|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605217|NCT00510874|E6|Reported Event|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605218|NCT00510874|E5|Reported Event|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605219|NCT00510874|E4|Reported Event|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605220|NCT00510874|E3|Reported Event|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605221|NCT00510874|E2|Reported Event|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605222|NCT00510874|E1|Reported Event|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
605223|NCT00510835|B4|Baseline|Total|Total of all reporting groups
605224|NCT00510835|B3|Baseline|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
605225|NCT00510835|B2|Baseline|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
605226|NCT00510835|B1|Baseline|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
605227|NCT00510835|P3|Participant Flow|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
605228|NCT00510835|P2|Participant Flow|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
605229|NCT00510835|P1|Participant Flow|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
605230|NCT00510835|O3|Outcome|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
605231|NCT00510835|O2|Outcome|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
605232|NCT00510835|O1|Outcome|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
605269|NCT00510692|P1|Participant Flow|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
605300|NCT00510510|E2|Reported Event|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605423|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605233|NCT00510835|E3|Reported Event|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
605234|NCT00510835|E2|Reported Event|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
605235|NCT00510835|E1|Reported Event|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
605236|NCT00510809|B4|Baseline|Total|Total of all reporting groups
605237|NCT00510809|B3|Baseline|Policosanol|20 mg daily, open label
605238|NCT00510809|B2|Baseline|Statin and Placebo|20mg daily, double-blind
605239|NCT00510809|B1|Baseline|Statin and Policosanol|20mg daily, double-blind
605240|NCT00510809|P3|Participant Flow|Policosanol|20 mg daily, open label
605241|NCT00510809|P2|Participant Flow|Statin and Placebo|20mg daily, double-blind
605242|NCT00510809|P1|Participant Flow|Statin and Policosanol|20mg daily, double-blind
605243|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
605244|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
605245|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
605246|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
605247|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
605248|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
605249|NCT00510809|E3|Reported Event|Policosanol|20 mg daily, open label
605250|NCT00510809|E2|Reported Event|Statin and Placebo|20mg daily, double-blind
605251|NCT00510809|E1|Reported Event|Statin and Policosanol|20mg daily, double-blind
605252|NCT00510783|B3|Baseline|Total|Total of all reporting groups
605253|NCT00510783|B2|Baseline|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
605254|NCT00510783|B1|Baseline|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
605255|NCT00510783|P2|Participant Flow|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
605256|NCT00510783|P1|Participant Flow|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
605257|NCT00510783|O2|Outcome|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
605258|NCT00510783|O1|Outcome|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
605259|NCT00510783|E2|Reported Event|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
605260|NCT00510783|E1|Reported Event|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
605261|NCT00510744|B1|Baseline|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
605262|NCT00510744|P1|Participant Flow|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
605263|NCT00510744|O1|Outcome|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~The ability of pancreatic enzyme supplement: 4 caps with meals, 2 with snacks to improve fat absorption"
605264|NCT00510744|E1|Reported Event|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
605265|NCT00510692|B3|Baseline|Total|Total of all reporting groups
605266|NCT00510692|B2|Baseline|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605267|NCT00510692|B1|Baseline|2g/Day EPA|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605270|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605271|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605272|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605273|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605274|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605275|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605276|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605277|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605278|NCT00510692|O2|Outcome|Placebo|Medium chain triglycerides 2g per day for six months
605279|NCT00510692|O1|Outcome|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
605280|NCT00510692|E2|Reported Event|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605281|NCT00510692|E1|Reported Event|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
605282|NCT00510653|B1|Baseline|Imatinib Mesylate|600 mg/day orally for 6 Weeks
605283|NCT00510653|P1|Participant Flow|Imatinib Mesylate|600 mg/day orally for 6 Weeks
605284|NCT00510653|O1|Outcome|Imatinib Mesylate|600 mg/day orally for 6 Weeks
605285|NCT00510653|E1|Reported Event|Imatinib Mesylate|600 mg/day orally for 6 Weeks
605286|NCT00510510|B4|Baseline|Total|Total of all reporting groups
605287|NCT00510510|B3|Baseline|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605288|NCT00510510|B2|Baseline|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605289|NCT00510510|B1|Baseline|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
605290|NCT00510510|P3|Participant Flow|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605291|NCT00510510|P2|Participant Flow|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605292|NCT00510510|P1|Participant Flow|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605293|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605294|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605295|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
605296|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605297|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
605301|NCT00510510|E1|Reported Event|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
605302|NCT00510497|B1|Baseline|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
605303|NCT00510497|P1|Participant Flow|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
605304|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
605305|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
605306|NCT00510497|E1|Reported Event|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine (does not include one enrolled participant who received no study treatment)~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
605307|NCT00510484|B3|Baseline|Total|Total of all reporting groups
605308|NCT00510484|B2|Baseline|Pancrelipase/Placebo|
605309|NCT00510484|B1|Baseline|Placebo/Pancrelipase|
605310|NCT00510484|P2|Participant Flow|Pancrelipase/Placebo|
605311|NCT00510484|P1|Participant Flow|Placebo/Pancrelipase|
605312|NCT00510484|O2|Outcome|Placebo|
605313|NCT00510484|O1|Outcome|Pancrelipase|
605314|NCT00510484|O2|Outcome|Placebo|
605315|NCT00510484|O1|Outcome|Pancrelipase|
605316|NCT00510484|O2|Outcome|Placebo|
605317|NCT00510484|O1|Outcome|Pancrelipase|
605318|NCT00510484|O2|Outcome|Placebo|
605319|NCT00510484|O1|Outcome|Pancrelipase|
605320|NCT00510484|O2|Outcome|Placebo|
605321|NCT00510484|O1|Outcome|Pancrelipase|
605322|NCT00510484|O2|Outcome|Placebo|
605323|NCT00510484|O1|Outcome|Pancrelipase|
605324|NCT00510484|O2|Outcome|Placebo|
605325|NCT00510484|O1|Outcome|Pancrelipase|
605326|NCT00510484|O2|Outcome|Placebo|
605327|NCT00510484|O1|Outcome|Pancrelipase|
605328|NCT00510484|E2|Reported Event|Placebo|
605329|NCT00510484|E1|Reported Event|Pancrelipase|
605330|NCT00510458|B1|Baseline|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605331|NCT00510458|P1|Participant Flow|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605332|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605333|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605334|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605335|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605336|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605337|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605338|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605339|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605340|NCT00510458|O1|Outcome|LFIT™Femoral Heads With X3® Insert|LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
605341|NCT00510458|E2|Reported Event|Non-operative Site Events|LFIT™ Femoral Heads With X3® Insert. Non-operative site events are reported by participant.
605342|NCT00510458|E1|Reported Event|Operative Site Events|LFIT™ Femoral Heads With X3® Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.
605343|NCT00510289|B1|Baseline|All Patients|All patients who signed consent
605344|NCT00510289|P1|Participant Flow|All Patients|All patients who signed consent
605345|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
605346|NCT00510289|O1|Outcome|Evaluable Patients|Patients who received at least one cycle of study drug and underwent bone marrow assessments
605347|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
605348|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
605930|NCT00509028|B3|Baseline|Total|Total of all reporting groups
605349|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
605350|NCT00510289|E1|Reported Event|All Patients|SAEs are listed for all patients who took at least one dose of study drug. Due to early study closure and patient withdrawals, Other AEs are listed for 9 patients only.
605351|NCT00510276|B3|Baseline|Total|Total of all reporting groups
605352|NCT00510276|B2|Baseline|Placebo|twice a day for 12 weeks
605353|NCT00510276|B1|Baseline|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605354|NCT00510276|P2|Participant Flow|Placebo|twice a day for 12 weeks
605355|NCT00510276|P1|Participant Flow|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605356|NCT00510276|O4|Outcome|Placebo, Non-Smokers|
605357|NCT00510276|O3|Outcome|Placebo, Smokers|
605358|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-Smokers|
605359|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
605360|NCT00510276|O4|Outcome|Placebo Non-smokers|
605361|NCT00510276|O3|Outcome|Placebo, Smokers|
605362|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-smokers|
605363|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
605364|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605365|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605366|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605367|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605368|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605369|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605370|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605371|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605372|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605373|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605374|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605375|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605376|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605377|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605378|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605379|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605380|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605381|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605382|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605383|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605384|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605385|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605386|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605387|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605388|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605389|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605390|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605391|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605392|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605393|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605394|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605395|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605396|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605397|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605398|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605399|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605400|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605401|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605402|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605403|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605404|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605405|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605406|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605407|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605408|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605409|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605410|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605411|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605412|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605413|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605414|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605415|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605416|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID and Placebo|
605417|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605418|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605419|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605424|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605425|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605426|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605427|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605428|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605429|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605430|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605431|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605432|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605433|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605434|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605435|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
605436|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605437|NCT00510276|E2|Reported Event|Placebo|twice a day for 12 weeks
605438|NCT00510276|E1|Reported Event|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
605439|NCT00510224|B1|Baseline|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
605440|NCT00510224|P1|Participant Flow|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
605441|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
605442|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
605443|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
605444|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
605445|NCT00510224|E1|Reported Event|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
605446|NCT00510146|B3|Baseline|Total|Total of all reporting groups
605447|NCT00510146|B2|Baseline|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605448|NCT00510146|B1|Baseline|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605449|NCT00510146|P2|Participant Flow|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605450|NCT00510146|P1|Participant Flow|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605451|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605452|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605453|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605454|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605455|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605456|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605541|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605840|NCT00509288|E2|Reported Event|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
605457|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605458|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605459|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605460|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605461|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605462|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605463|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605464|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605465|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605466|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605467|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605468|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605469|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605542|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605470|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605471|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605472|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
605473|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605474|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605475|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605476|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605477|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605478|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605479|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605480|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605481|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605482|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605483|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605484|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605485|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605486|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605487|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605488|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605489|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605490|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605491|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605543|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605492|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605493|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605494|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605495|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605496|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605497|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605498|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605499|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605500|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605501|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605502|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605503|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605504|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605505|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605506|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605507|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605508|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605509|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605510|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605511|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605512|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605513|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605514|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605515|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605544|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605516|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605517|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605518|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605519|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605520|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605521|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605522|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605523|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605524|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605525|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605526|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605527|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605528|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605529|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605530|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605531|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605532|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
605533|NCT00510146|E3|Reported Event|Olanzapine (Open Label Treatment Period|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Visit 9. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Visit 10. Those on higher doses will be reduced between Visit 9 and 10 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at visit 10; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at visit 10). Dose increases beyond visit 10 are permitted and at the investigator's discretion.
605534|NCT00510146|E2|Reported Event|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
605535|NCT00510146|E1|Reported Event|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg. which is increased to 10 mg. per day no later than 3-7 days after Visit 2. Subsequent dose increases above 10 mg. (up to a maximum of 20 mg per day) are permitted in 5 mg. per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg. requires study discontinuation.
605536|NCT00510068|B3|Baseline|Total|Total of all reporting groups
605537|NCT00510068|B2|Baseline|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605538|NCT00510068|B1|Baseline|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605539|NCT00510068|P2|Participant Flow|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605540|NCT00510068|P1|Participant Flow|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605545|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605546|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605547|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605548|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605549|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605550|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605551|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605552|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605553|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605554|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605555|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605556|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605557|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605558|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605559|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605560|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605561|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605562|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605563|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605564|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605565|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605566|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605567|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605568|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605569|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605570|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605571|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605572|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605573|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605574|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605575|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605576|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605577|NCT00510068|E3|Reported Event|Open Label - Everolimus 10mg|Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
605578|NCT00510068|E2|Reported Event|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
605579|NCT00510068|E1|Reported Event|Everolimus 10mg/Day|Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
605580|NCT00509925|B1|Baseline|Entire Trial Population|The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment.
605581|NCT00509925|P2|Participant Flow|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605582|NCT00509925|P1|Participant Flow|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605583|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605584|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605585|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605586|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605587|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605588|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605589|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605590|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605591|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605592|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605593|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605594|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605595|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605596|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605597|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605598|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605599|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605600|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605601|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605602|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605603|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605890|NCT00509197|P1|Participant Flow|Fluticasone 500 mcg Bid|Treatment with Inhaled Corticosteroids
605604|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605605|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605606|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
605607|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605608|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605609|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605610|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605611|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605612|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605613|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605614|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605615|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605616|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605617|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605618|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605619|NCT00509925|E2|Reported Event|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605620|NCT00509925|E1|Reported Event|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
605621|NCT00509899|B9|Baseline|Total|Total of all reporting groups
605622|NCT00509899|B8|Baseline|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605623|NCT00509899|B7|Baseline|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605624|NCT00509899|B6|Baseline|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605625|NCT00509899|B5|Baseline|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
605626|NCT00509899|B4|Baseline|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605627|NCT00509899|B3|Baseline|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605628|NCT00509899|B2|Baseline|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605629|NCT00509899|B1|Baseline|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605630|NCT00509899|P8|Participant Flow|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605631|NCT00509899|P7|Participant Flow|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605632|NCT00509899|P6|Participant Flow|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605633|NCT00509899|P5|Participant Flow|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
605634|NCT00509899|P4|Participant Flow|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605694|NCT00509795|B2|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605635|NCT00509899|P3|Participant Flow|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605636|NCT00509899|P2|Participant Flow|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605637|NCT00509899|P1|Participant Flow|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605638|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
605639|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605640|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605641|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605642|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605643|NCT00509899|O1|Outcome|All Participants|All participants received ruxolitinib at varying initial dose and regimen. Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605644|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
605645|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605646|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605647|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605648|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
605649|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605650|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605651|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605652|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605653|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605654|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
605655|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605656|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605657|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605891|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
605658|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605659|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
605660|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605661|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605662|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605663|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605664|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
605665|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605666|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605667|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605668|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605669|NCT00509899|E5|Reported Event|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
605670|NCT00509899|E4|Reported Event|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605671|NCT00509899|E3|Reported Event|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
605672|NCT00509899|E2|Reported Event|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605673|NCT00509899|E1|Reported Event|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
605674|NCT00509873|B3|Baseline|Total|Total of all reporting groups
605675|NCT00509873|B2|Baseline|Placebo Eye Drops|Placebo eye drops
605676|NCT00509873|B1|Baseline|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605677|NCT00509873|P2|Participant Flow|Placebo Eye Drops|Placebo eye drops
605678|NCT00509873|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605679|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
605680|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605681|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
605682|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605683|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
605684|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605685|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
605686|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605687|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
605688|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605689|NCT00509873|E2|Reported Event|Placebo Eye Drops|Placebo eye drops
605690|NCT00509873|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
605691|NCT00509795|B5|Baseline|Total|Total of all reporting groups
605692|NCT00509795|B4|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
605693|NCT00509795|B3|Baseline|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
614616|NCT00486291|B3|Baseline|Total|Total of all reporting groups
605695|NCT00509795|B1|Baseline|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
605696|NCT00509795|P4|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.
605697|NCT00509795|P3|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605698|NCT00509795|P2|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605699|NCT00509795|P1|Participant Flow|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.
605700|NCT00509795|O5|Outcome|Total|
605701|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
605702|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605703|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605704|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
605705|NCT00509795|O5|Outcome|Total|
605706|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
605707|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605708|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605709|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
605710|NCT00509795|O5|Outcome|Total|
605711|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
605712|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605713|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605714|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
605715|NCT00509795|O5|Outcome|Total|
605716|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
605717|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605718|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605719|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
605720|NCT00509795|O5|Outcome|Total|
605721|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
605722|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605723|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
605724|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
605725|NCT00509795|E4|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
605726|NCT00509795|E3|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
605773|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605774|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605727|NCT00509795|E2|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
605728|NCT00509795|E1|Reported Event|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
605729|NCT00509769|B1|Baseline|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605730|NCT00509769|P1|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605731|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605732|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605733|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605734|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605735|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605736|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605737|NCT00509769|E1|Reported Event|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
605738|NCT00509600|B1|Baseline|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
605739|NCT00509600|P1|Participant Flow|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
605740|NCT00509600|O1|Outcome|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
605741|NCT00509600|E1|Reported Event|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
605742|NCT00509587|B1|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605743|NCT00509587|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605744|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605745|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605746|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605747|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605748|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605749|NCT00509587|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
605750|NCT00509496|B3|Baseline|Total|Total of all reporting groups
605751|NCT00509496|B2|Baseline|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605752|NCT00509496|B1|Baseline|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605753|NCT00509496|P2|Participant Flow|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605754|NCT00509496|P1|Participant Flow|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605755|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605756|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605757|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605758|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605759|NCT00509496|E2|Reported Event|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605760|NCT00509496|E1|Reported Event|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
605761|NCT00509392|B3|Baseline|Total|Total of all reporting groups
605762|NCT00509392|B2|Baseline|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605763|NCT00509392|B1|Baseline|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605764|NCT00509392|P3|Participant Flow|RF / EVLA|Bilateral treatment where one limb is treated with RFA and the contralateral limb is treated with EVL
605765|NCT00509392|P2|Participant Flow|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605766|NCT00509392|P1|Participant Flow|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605767|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605768|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605769|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605770|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605771|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605772|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
614617|NCT00486291|B2|Baseline|Placebo|Matched placebo
605775|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605776|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605777|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605778|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605779|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605780|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605781|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605782|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605783|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605784|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605785|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605786|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605787|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605788|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605789|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605790|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605791|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605792|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605793|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605794|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605795|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605796|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605797|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605798|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605799|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605800|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605801|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605802|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605803|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605804|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605805|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605806|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605807|NCT00509392|O2|Outcome|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605808|NCT00509392|O1|Outcome|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605809|NCT00509392|E2|Reported Event|Endovenous Laser (EVL) Ablation|Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
605810|NCT00509392|E1|Reported Event|Radiofrequency (RF) Ablation|Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)
605811|NCT00509366|B6|Baseline|Total|Total of all reporting groups
605812|NCT00509366|B5|Baseline|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility.
605813|NCT00509366|B4|Baseline|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
605814|NCT00509366|B3|Baseline|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
605815|NCT00509366|B2|Baseline|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study.
605816|NCT00509366|B1|Baseline|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study.
605817|NCT00509366|P5|Participant Flow|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
605818|NCT00509366|P4|Participant Flow|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology.
605819|NCT00509366|P3|Participant Flow|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure.
605820|NCT00509366|P2|Participant Flow|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure.
605821|NCT00509366|P1|Participant Flow|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure.
605822|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study.
605823|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive (cisplatin/pemetrexed or cisplatin/gemcitabine) and resistant (pemetrexed/gemcitabine or docetaxel/gemcitabine) arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
605824|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
605825|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
605826|NCT00509366|E5|Reported Event|Screen Failure|Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
605827|NCT00509366|E4|Reported Event|Cisplatin Resistant (Post-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
605828|NCT00509366|E3|Reported Event|Cisplatin Resistant (Pre-Amendment)|Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010.
605829|NCT00509366|E2|Reported Event|Cisplatin Sensitive (Post-Amendment)|Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
605830|NCT00509366|E1|Reported Event|Cisplatin Sensitive (Pre-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010.
605831|NCT00509288|B3|Baseline|Total|Total of all reporting groups
605832|NCT00509288|B2|Baseline|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
605833|NCT00509288|B1|Baseline|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
605834|NCT00509288|P2|Participant Flow|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
605835|NCT00509288|P1|Participant Flow|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
605836|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
605837|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
605838|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
605839|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
614618|NCT00486291|B1|Baseline|Active|Phentermine 15mg/topiramate 100mg
605841|NCT00509288|E1|Reported Event|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
605842|NCT00509262|B3|Baseline|Total|Total of all reporting groups
605843|NCT00509262|B2|Baseline|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
605844|NCT00509262|B1|Baseline|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
605845|NCT00509262|P2|Participant Flow|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
605846|NCT00509262|P1|Participant Flow|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
605847|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
605848|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
605849|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
605850|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
605851|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
605852|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
605853|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
605854|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
605855|NCT00509262|E2|Reported Event|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
605856|NCT00509262|E1|Reported Event|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
605857|NCT00509249|B1|Baseline|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
605858|NCT00509249|P1|Participant Flow|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
605859|NCT00509249|O1|Outcome|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
605860|NCT00509249|E1|Reported Event|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
605861|NCT00509236|B3|Baseline|Total|Total of all reporting groups
605862|NCT00509236|B2|Baseline|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
605863|NCT00509236|B1|Baseline|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
605864|NCT00509236|P2|Participant Flow|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
605865|NCT00509236|P1|Participant Flow|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
605866|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
605867|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
605868|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
605869|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
605870|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
605871|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
605872|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
605873|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
605874|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
605875|NCT00509236|E2|Reported Event|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
605876|NCT00509236|E1|Reported Event|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
605877|NCT00509223|B3|Baseline|Total|Total of all reporting groups
605878|NCT00509223|B2|Baseline|Lifestyle Counseling|
605879|NCT00509223|B1|Baseline|Lifestyle Counseling With PAP Therapy|
605880|NCT00509223|P2|Participant Flow|Group 2|"Lifestyle counseling without Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations."
605881|NCT00509223|P1|Participant Flow|Group 1|"Lifestyle counseling with Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.~Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep."
605882|NCT00509223|O2|Outcome|Lifestyle Counseling|
605883|NCT00509223|O1|Outcome|Lifestyle Counseling With PAP Therapy|
605884|NCT00509223|E2|Reported Event|Lifestyle Counseling With PAP Therapy|
605885|NCT00509223|E1|Reported Event|Lifestyle Counseling|
605886|NCT00509197|B3|Baseline|Total|Total of all reporting groups
605887|NCT00509197|B2|Baseline|Placebo|Treatment with placebo
605888|NCT00509197|B1|Baseline|Fluticasone 500 mcg Bid|Treatment with inhaled corticosteroids
605889|NCT00509197|P2|Participant Flow|Placebo|treatment with placebo
605897|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
605898|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
605899|NCT00509197|E2|Reported Event|Placebo|Treatment with placebo
605900|NCT00509197|E1|Reported Event|Fluticasone 500 mcg Bid|Treatment with inhaled Corticosteroids
605901|NCT00509106|B3|Baseline|Total|Total of all reporting groups
605902|NCT00509106|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
605903|NCT00509106|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
605904|NCT00509106|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
605905|NCT00509106|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
605906|NCT00509106|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
605907|NCT00509106|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
605908|NCT00509106|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
605909|NCT00509106|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
605910|NCT00509067|B3|Baseline|Total|Total of all reporting groups
605911|NCT00509067|B2|Baseline|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
605912|NCT00509067|B1|Baseline|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
605913|NCT00509067|P2|Participant Flow|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
605914|NCT00509067|P1|Participant Flow|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
605915|NCT00509067|O2|Outcome|Placebo Group|"Participants assigned to receive placebo~Placebo: The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment."
605916|NCT00509067|O1|Outcome|Galantamine and CDP-choline Group|"Participants assigned to receive galantamine/CDP-choline~Galantamine: Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.~CDP-choline: CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, zipr"
605917|NCT00509067|O2|Outcome|Placebo Group|"Participants assigned to placebo~Placebo: The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment."
605918|NCT00509067|O1|Outcome|Galantamine and CDP-choline Group|"Participants assigned to galantamine and CDP-choline~Galantamine: Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.~CDP-choline: CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.~risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, zipr"
605919|NCT00509067|O2|Outcome|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
605920|NCT00509067|O1|Outcome|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
605921|NCT00509067|E2|Reported Event|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
605922|NCT00509067|E1|Reported Event|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
605923|NCT00509041|B1|Baseline|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
605924|NCT00509041|P1|Participant Flow|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
605925|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
605926|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
605927|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
605928|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
605929|NCT00509041|E1|Reported Event|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
605931|NCT00509028|B2|Baseline|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605932|NCT00509028|B1|Baseline|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605933|NCT00509028|P2|Participant Flow|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605934|NCT00509028|P1|Participant Flow|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605935|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605936|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605937|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605938|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605939|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605940|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605941|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605942|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605943|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605944|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605945|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605946|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605947|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605948|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605949|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605950|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605951|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605952|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605953|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605954|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605955|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605956|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605957|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605958|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605959|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605960|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605961|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605962|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605963|NCT00509028|E2|Reported Event|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
605964|NCT00509028|E1|Reported Event|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
605965|NCT00509002|B1|Baseline|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
605966|NCT00509002|P1|Participant Flow|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
605967|NCT00509002|O1|Outcome|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
605968|NCT00509002|E1|Reported Event|Gefitinib|Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
605969|NCT00508924|B5|Baseline|Total|Total of all reporting groups
605970|NCT00508924|B4|Baseline|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
605971|NCT00508924|B3|Baseline|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605972|NCT00508924|B2|Baseline|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605973|NCT00508924|B1|Baseline|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
614619|NCT00486291|P2|Participant Flow|Placebo|Matched placebo
605974|NCT00508924|P4|Participant Flow|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
605975|NCT00508924|P3|Participant Flow|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605976|NCT00508924|P2|Participant Flow|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605977|NCT00508924|P1|Participant Flow|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605978|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
605979|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605980|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605981|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605982|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
605983|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605984|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605985|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605986|NCT00508924|E4|Reported Event|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
605987|NCT00508924|E3|Reported Event|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605988|NCT00508924|E2|Reported Event|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605989|NCT00508924|E1|Reported Event|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
605990|NCT00508872|B1|Baseline|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
605991|NCT00508872|P1|Participant Flow|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
605992|NCT00508872|O1|Outcome|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
605993|NCT00508872|E1|Reported Event|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
605994|NCT00508820|B3|Baseline|Total|Total of all reporting groups
605995|NCT00508820|B2|Baseline|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
605996|NCT00508820|B1|Baseline|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
605997|NCT00508820|P2|Participant Flow|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
605998|NCT00508820|P1|Participant Flow|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
605999|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
606000|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
606001|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
606002|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
606003|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
606004|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
606005|NCT00508820|E2|Reported Event|Romiplostim Cohort 2|
606006|NCT00508820|E1|Reported Event|Romiplostim Cohort 1|
606007|NCT00508755|B1|Baseline|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
615763|NCT00483184|P3|Participant Flow|3|(Veldona)1000 IU IFNα bid
606008|NCT00508755|P1|Participant Flow|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
606009|NCT00508755|O3|Outcome|Combined Gait Robot and FES|The 6 study subjects with chronic stroke ambulated with combination Gait Robot and FES, and observational gait analysis was performed.
606010|NCT00508755|O2|Outcome|FES-Alone|The 6 study subjects with chronic stroke ambulated with FES, and observational gait analysis was performed.
606011|NCT00508755|O1|Outcome|Gait Robot-alone Training|The 6 study subjects with chronic stroke ambulated in the Gait Robot, and observational gait analysis was performed.
606012|NCT00508755|E1|Reported Event|Gait Training After Stroke|subjects with Chronic stroke (.5-1.5 years post stroke)received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and Gait Robot.
606013|NCT00508742|B3|Baseline|Total|Total of all reporting groups
606014|NCT00508742|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606015|NCT00508742|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606016|NCT00508742|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606017|NCT00508742|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606018|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606019|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606020|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606021|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
606022|NCT00508742|E8|Reported Event|After Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
606023|NCT00508742|E7|Reported Event|After Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
606024|NCT00508742|E6|Reported Event|Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
606025|NCT00508742|E5|Reported Event|Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
606026|NCT00508742|E4|Reported Event|After Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
606027|NCT00508742|E3|Reported Event|After Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
606028|NCT00508742|E2|Reported Event|Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
606029|NCT00508742|E1|Reported Event|Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
606030|NCT00508716|B3|Baseline|Total|Total of all reporting groups
606031|NCT00508716|B2|Baseline|Tailored Intervention for Patients With Low Health Literacy an|"Tailored Intervention for patients with low health literacy and nurse-directed teachback~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
606032|NCT00508716|B1|Baseline|Usual Care|CHF Education by usual Nurse without teach-back or Video.
606033|NCT00508716|P2|Participant Flow|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
606034|NCT00508716|P1|Participant Flow|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
606035|NCT00508716|O2|Outcome|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
606036|NCT00508716|O1|Outcome|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
606037|NCT00508716|E2|Reported Event|Teilored Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
606038|NCT00508716|E1|Reported Event|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
606039|NCT00508651|B3|Baseline|Total|Total of all reporting groups
606040|NCT00508651|B2|Baseline|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606041|NCT00508651|B1|Baseline|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606042|NCT00508651|P2|Participant Flow|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606043|NCT00508651|P1|Participant Flow|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606044|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606045|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606046|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606047|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606048|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606049|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606050|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606051|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606052|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606053|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606054|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606055|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606056|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606057|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606058|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606059|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606060|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606061|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606062|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606063|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606064|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606065|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606282|NCT00508118|O1|Outcome|NICARDIPINE GROUP|Nicardipine prior to bypass
615764|NCT00483184|P2|Participant Flow|2|(Veldona)500 IU IFNα bid
606066|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606067|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606068|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606069|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606070|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606071|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606072|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606073|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606074|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606075|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606076|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606077|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606078|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606079|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606080|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606081|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606082|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606083|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606084|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606085|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606086|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606087|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606088|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606089|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606090|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606091|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606092|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606093|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606094|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606095|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606096|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606097|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606098|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606099|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606100|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606101|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606102|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606103|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606104|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606105|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606106|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606107|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606108|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606109|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606110|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606111|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606112|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606113|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606114|NCT00508651|E2|Reported Event|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
606115|NCT00508651|E1|Reported Event|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
606116|NCT00508521|B1|Baseline|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
606117|NCT00508521|P1|Participant Flow|FES and Motor Learning Training Group|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
606118|NCT00508521|O1|Outcome|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
606119|NCT00508521|E1|Reported Event|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
606120|NCT00508482|B4|Baseline|Total|Total of all reporting groups
606121|NCT00508482|B3|Baseline|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606122|NCT00508482|B2|Baseline|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606123|NCT00508482|B1|Baseline|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606124|NCT00508482|P3|Participant Flow|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606125|NCT00508482|P2|Participant Flow|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606126|NCT00508482|P1|Participant Flow|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606127|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606128|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606129|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606130|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606131|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606132|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606133|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606134|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606135|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606136|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606137|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606138|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606139|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606140|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606141|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606283|NCT00508118|E2|Reported Event|0.9% Saline|0.9% saline (placebo) before bypass
606142|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606143|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606144|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606145|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606146|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606147|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606148|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606149|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606150|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606151|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606152|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606153|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606154|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606155|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606156|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606157|NCT00508482|E3|Reported Event|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
606158|NCT00508482|E2|Reported Event|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
606284|NCT00508118|E1|Reported Event|Nicardipine|Nicardipine infusion before bypass
606327|NCT00508001|P3|Participant Flow|Placebo|Placebo plus Best Support Care
606159|NCT00508482|E1|Reported Event|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
606160|NCT00508469|B3|Baseline|Total|Total of all reporting groups
606161|NCT00508469|B2|Baseline|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
606162|NCT00508469|B1|Baseline|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
606163|NCT00508469|P2|Participant Flow|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
606164|NCT00508469|P1|Participant Flow|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
606165|NCT00508469|O2|Outcome|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
606166|NCT00508469|O1|Outcome|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
606167|NCT00508469|E2|Reported Event|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
606168|NCT00508469|E1|Reported Event|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
606169|NCT00508404|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606170|NCT00508404|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606171|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606172|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606173|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606174|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606175|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606176|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606177|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606178|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606179|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606180|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606181|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606182|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606183|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606184|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606185|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606186|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606187|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606188|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606189|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606190|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606191|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606192|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606193|NCT00508404|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
606194|NCT00508391|B3|Baseline|Total|Total of all reporting groups
606195|NCT00508391|B2|Baseline|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
606196|NCT00508391|B1|Baseline|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
606197|NCT00508391|P2|Participant Flow|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
606198|NCT00508391|P1|Participant Flow|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
606199|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
606200|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
606201|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
606202|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
606203|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
606204|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
606205|NCT00508391|E3|Reported Event|Total Subjects|Total subjects enrolled in study.
606206|NCT00508391|E2|Reported Event|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
606207|NCT00508391|E1|Reported Event|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
606208|NCT00508274|B1|Baseline|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606209|NCT00508274|P1|Participant Flow|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606210|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606211|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606212|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606213|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606214|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606328|NCT00508001|P2|Participant Flow|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
606215|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606216|NCT00508274|E1|Reported Event|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
606217|NCT00508183|B3|Baseline|Total|Total of all reporting groups
606218|NCT00508183|B2|Baseline|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606219|NCT00508183|B1|Baseline|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606220|NCT00508183|P2|Participant Flow|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606221|NCT00508183|P1|Participant Flow|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606222|NCT00508183|O2|Outcome|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606223|NCT00508183|O1|Outcome|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606224|NCT00508183|O2|Outcome|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606225|NCT00508183|O1|Outcome|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606226|NCT00508183|O2|Outcome|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606227|NCT00508183|O1|Outcome|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606228|NCT00508183|O2|Outcome|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606229|NCT00508183|O1|Outcome|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606230|NCT00508183|O2|Outcome|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606231|NCT00508183|O1|Outcome|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606232|NCT00508183|E2|Reported Event|Double Row Fixation|"double row fixation: This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair."
606233|NCT00508183|E1|Reported Event|Single Row Fixation|single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.
606234|NCT00508157|B3|Baseline|Total|Total of all reporting groups
606235|NCT00508157|B2|Baseline|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606236|NCT00508157|B1|Baseline|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606237|NCT00508157|P2|Participant Flow|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606238|NCT00508157|P1|Participant Flow|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606239|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606240|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606241|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606242|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606243|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606244|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606245|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606246|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606247|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606248|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606249|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606250|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606251|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606252|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606253|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606254|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606255|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606256|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606257|NCT00508157|E2|Reported Event|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
606258|NCT00508157|E1|Reported Event|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
606259|NCT00508144|B1|Baseline|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
606260|NCT00508144|P1|Participant Flow|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
606261|NCT00508144|O1|Outcome|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
606262|NCT00508144|E1|Reported Event|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
606263|NCT00508118|B3|Baseline|Total|Total of all reporting groups
606264|NCT00508118|B2|Baseline|0.9% Saline|0.9% saline (placebo) before bypass
606265|NCT00508118|B1|Baseline|Nicardipine|Nicardipine infusion before bypass
606266|NCT00508118|P2|Participant Flow|0.9% Saline|0.9% saline (placebo) infusion before bypass
606285|NCT00508027|B1|Baseline|Simvastatin, Dose Escalation|"There are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Simvastatin : Comparison of 3 dosages of simvastatin given in a dose-escalating fashion.~20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days."
606329|NCT00508001|P1|Participant Flow|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
606267|NCT00508118|P1|Participant Flow|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606268|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
606269|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606270|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
606271|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606272|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
606273|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606274|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
606275|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606276|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
606277|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606278|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
606279|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606280|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
606281|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
606286|NCT00508027|P1|Participant Flow|Simvastatin, 3 Escalating Dose Groups|"Simvastatin was given in a dose-escalating fashion to 3 sequential dose groups:~dose level 1= 20 mg/day, dose level 2= 40 mg/day, dose level 3= 80 mg/day The number of subjects starting each dose level are new cohorts of subjects.~Determination of clinical safety in the first dose level group was required in order to begin enrollment in the second dose level group and ultimately the third dose group. Enrollment in the third dose level was discontinued early due to newly reported FDA warnings regarding high dose (80mg/day) simvastatin."
606287|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606288|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606289|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
606290|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606291|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606292|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
606293|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606294|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606295|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
606296|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606297|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606298|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
606299|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|"Subjects received 80 mg daily. Data collected for only 2 participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage"
606300|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606301|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
606302|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606303|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606304|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
606305|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606306|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606307|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
606308|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606309|NCT00508027|O2|Outcome|Dose Level 2|All participants received 40 mg of simvastatin once daily
606310|NCT00508027|O1|Outcome|Dose Level 1|All participants received 20mg simvastatin once daily
606311|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606312|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606313|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
606314|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606315|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606316|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
606317|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; biomarker data were not collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
606318|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
606319|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
606320|NCT00508027|E3|Reported Event|Simvastatin, Dose 3|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 3 = 80mg/day for 21 days, followed by 4-day drug taper. Enrollment in this group discontinued early due to FDA warning re. high dose simvastatin"
606321|NCT00508027|E2|Reported Event|Simvastatin, Dose 2|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 2 = 40mg/day for 21 days, followed by a 4-day taper."
606322|NCT00508027|E1|Reported Event|Simvastatin, Dose 1|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 1 = 20mg/day for 21 days, followed by 4-day drug taper."
606323|NCT00508001|B4|Baseline|Total|Total of all reporting groups
606324|NCT00508001|B3|Baseline|Placebo|Placebo plus Best Support Care
606325|NCT00508001|B2|Baseline|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
606326|NCT00508001|B1|Baseline|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
606331|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
606332|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
606333|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
606334|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
606335|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
606336|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
606337|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
606338|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
606339|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
606340|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
606341|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
606342|NCT00508001|E3|Reported Event|Placebo|Placebo plus Best Support Care
606343|NCT00508001|E2|Reported Event|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
606344|NCT00508001|E1|Reported Event|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
606345|NCT00507819|B1|Baseline|Study Population|Subjects who were randomized to receive either Sildenafil 20mg three times a day by mouth or Placebo three times a day by mouth.
606346|NCT00507819|P2|Participant Flow|Placebo, Then Sildenafil|Placebo six weeks followed by a six week washout period followed by Sildenafil which will be given at a dose of 20 mg three times-a-day for six weeks
606347|NCT00507819|P1|Participant Flow|Sildenafil, Then Placebo|Sildenafil will be given at a dose of 20 mg three times-a-day for six weeks followed by a six week washout period followed by placebo for an additional six weeks.
606348|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
606349|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
606350|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
606351|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
606352|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
606353|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
606354|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
606355|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
606356|NCT00507819|E2|Reported Event|Placebo|Placebo was given by mouth three times a day for six weeks
606357|NCT00507819|E1|Reported Event|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
606358|NCT00507767|B1|Baseline|Dasatinib|100 mg orally twice daily
606359|NCT00507767|P1|Participant Flow|Dasatinib|100 mg orally twice daily
606360|NCT00507767|O1|Outcome|Dasatinib|100 mg orally twice daily
606361|NCT00507767|E1|Reported Event|Dasatinib|100 mg orally twice daily
606362|NCT00507689|B4|Baseline|Total|Total of all reporting groups
606363|NCT00507689|B3|Baseline|Not Randomized|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606364|NCT00507689|B2|Baseline|FTC/TDF|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606365|NCT00507689|B1|Baseline|FTC/TDF+HBIg|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606366|NCT00507689|P2|Participant Flow|FTC/TDF|For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
606367|NCT00507689|P1|Participant Flow|FTC/TDF+HBIg|For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606368|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606369|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606370|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606371|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606372|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606373|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606374|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606375|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606376|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606377|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606378|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606379|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606380|NCT00507689|E3|Reported Event|FTC/TDF, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606381|NCT00507689|E2|Reported Event|FTC/TDF+HBIg, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606382|NCT00507689|E1|Reported Event|FTC/TDF+HBIg, Pre-randomization Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the pre-randomization period, and were analyzed from pretreatment baseline to Week 24 (pre-randomization period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
606383|NCT00507559|B1|Baseline|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606384|NCT00507559|P1|Participant Flow|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606385|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606386|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606387|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606388|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606389|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606390|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606391|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606392|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606393|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606394|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606395|NCT00507559|E1|Reported Event|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
606396|NCT00507546|B3|Baseline|Total|Total of all reporting groups
606397|NCT00507546|B2|Baseline|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
606398|NCT00507546|B1|Baseline|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
606399|NCT00507546|P2|Participant Flow|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
606400|NCT00507546|P1|Participant Flow|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
606401|NCT00507546|O2|Outcome|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
606402|NCT00507546|O1|Outcome|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
606403|NCT00507546|O2|Outcome|Placebo|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
606404|NCT00507546|O1|Outcome|Ramelteon|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
606405|NCT00507546|E2|Reported Event|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
606406|NCT00507546|E1|Reported Event|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
606407|NCT00507507|B3|Baseline|Total|Total of all reporting groups
606408|NCT00507507|B2|Baseline|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606409|NCT00507507|B1|Baseline|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606410|NCT00507507|P2|Participant Flow|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606411|NCT00507507|P1|Participant Flow|Tenofovir DF|Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily.
606412|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606413|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606414|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606415|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606416|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606417|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606418|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606419|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606420|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606421|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606422|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606423|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606424|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606425|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606426|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606427|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606428|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606429|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606430|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606431|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606432|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606433|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606434|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606435|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606436|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
606437|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
606438|NCT00507507|E4|Reported Event|FTC+Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the FTC+Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
606439|NCT00507507|E3|Reported Event|Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
606440|NCT00507507|E2|Reported Event|FTC+Tenofovir DF (Treatment Period)|"Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.~AEs for this reporting group are reported for the entire treatment period."
606441|NCT00507507|E1|Reported Event|Tenofovir DF (Treatment Period)|"Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.~Adverse events (AEs) for this reporting group are reported for the entire treatment period."
606442|NCT00507455|B4|Baseline|Total|Total of all reporting groups
606443|NCT00507455|B3|Baseline|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606444|NCT00507455|B2|Baseline|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606445|NCT00507455|B1|Baseline|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606755|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606446|NCT00507455|P3|Participant Flow|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS)tablets for 12 weeks.
606447|NCT00507455|P2|Participant Flow|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets for 12 weeks.
606448|NCT00507455|P1|Participant Flow|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606449|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606450|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606451|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606452|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606453|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606454|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606455|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606456|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606457|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606458|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606459|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606460|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606461|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606462|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606463|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606464|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606465|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606466|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606467|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606468|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606469|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606470|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606471|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606472|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606473|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606474|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606475|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606476|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606477|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606478|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606479|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606480|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606481|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606482|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606483|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606484|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606485|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606486|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606487|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606488|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606489|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606490|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606491|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606492|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606493|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606494|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606495|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606496|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606497|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606498|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606499|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606500|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606501|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606502|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606503|NCT00507455|E3|Reported Event|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606504|NCT00507455|E2|Reported Event|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
606505|NCT00507455|E1|Reported Event|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
606506|NCT00507442|B5|Baseline|Total|Total of all reporting groups
606507|NCT00507442|B4|Baseline|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606508|NCT00507442|B3|Baseline|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606509|NCT00507442|B2|Baseline|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606510|NCT00507442|B1|Baseline|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606511|NCT00507442|P4|Participant Flow|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606512|NCT00507442|P3|Participant Flow|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606513|NCT00507442|P2|Participant Flow|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606661|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606514|NCT00507442|P1|Participant Flow|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606515|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606516|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606517|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606518|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606519|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606520|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606521|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606522|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606523|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606524|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606525|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606526|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606527|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606528|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606529|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606530|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606531|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606532|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606533|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606534|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606535|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606536|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606537|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606538|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606539|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606540|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606541|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606542|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606543|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606544|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606545|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606546|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606547|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606548|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606549|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606550|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606551|NCT00507442|O4|Outcome|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606552|NCT00507442|O3|Outcome|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606553|NCT00507442|O2|Outcome|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606554|NCT00507442|O1|Outcome|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606555|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606556|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606557|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606558|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606559|NCT00507442|E4|Reported Event|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
606560|NCT00507442|E3|Reported Event|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
606561|NCT00507442|E2|Reported Event|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606562|NCT00507442|E1|Reported Event|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
606563|NCT00507429|B3|Baseline|Total|Total of all reporting groups
606564|NCT00507429|B2|Baseline|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
606565|NCT00507429|B1|Baseline|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
606566|NCT00507429|P2|Participant Flow|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
606567|NCT00507429|P1|Participant Flow|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
606568|NCT00507429|O2|Outcome|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
606569|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
606570|NCT00507429|O2|Outcome|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
606571|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
606572|NCT00507429|E2|Reported Event|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
606573|NCT00507429|E1|Reported Event|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
606575|NCT00507416|B3|Baseline|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606576|NCT00507416|B2|Baseline|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606577|NCT00507416|B1|Baseline|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606578|NCT00507416|P3|Participant Flow|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606579|NCT00507416|P2|Participant Flow|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606580|NCT00507416|P1|Participant Flow|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606581|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606582|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606583|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606584|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606585|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606586|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606587|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606588|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606589|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606590|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606591|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606592|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606593|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606594|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606595|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606596|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606597|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606598|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606599|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606600|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606601|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606602|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606603|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606604|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606605|NCT00507416|E3|Reported Event|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606606|NCT00507416|E2|Reported Event|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606607|NCT00507416|E1|Reported Event|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
606608|NCT00507208|B3|Baseline|Total|Total of all reporting groups
606609|NCT00507208|B2|Baseline|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
606610|NCT00507208|B1|Baseline|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
615765|NCT00483184|P1|Participant Flow|1|(placebo)0 IU IFN alpha
606611|NCT00507208|P2|Participant Flow|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
606612|NCT00507208|P1|Participant Flow|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
606613|NCT00507208|O2|Outcome|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
606614|NCT00507208|O1|Outcome|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
606615|NCT00507208|E2|Reported Event|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
606616|NCT00507208|E1|Reported Event|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
606617|NCT00507130|B5|Baseline|Total|Total of all reporting groups
606618|NCT00507130|B4|Baseline|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606619|NCT00507130|B3|Baseline|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606620|NCT00507130|B2|Baseline|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606621|NCT00507130|B1|Baseline|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606622|NCT00507130|P4|Participant Flow|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606623|NCT00507130|P3|Participant Flow|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606624|NCT00507130|P2|Participant Flow|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606625|NCT00507130|P1|Participant Flow|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606626|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606627|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606628|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606629|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606630|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606631|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606632|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606633|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606634|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606635|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606636|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606637|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606638|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606639|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606640|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606641|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606642|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606643|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606644|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606645|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606646|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606647|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606648|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606649|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606650|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606651|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606652|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606653|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606654|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606655|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606656|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606657|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606658|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606659|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606660|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
615766|NCT00483184|O3|Outcome|3|(Veldona)1000 IU IFNα bid
606662|NCT00507130|E4|Reported Event|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
606663|NCT00507130|E3|Reported Event|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
606664|NCT00507130|E2|Reported Event|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
606665|NCT00507130|E1|Reported Event|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
606666|NCT00506948|B1|Baseline|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
606667|NCT00506948|P1|Participant Flow|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
606668|NCT00506948|O1|Outcome|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
606669|NCT00506948|E1|Reported Event|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
606670|NCT00506922|B6|Baseline|Total|Total of all reporting groups
606671|NCT00506922|B5|Baseline|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
606672|NCT00506922|B4|Baseline|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
606673|NCT00506922|B3|Baseline|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
606674|NCT00506922|B2|Baseline|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
606675|NCT00506922|B1|Baseline|No Pentostatin|Group 1: No Pentostatin
606676|NCT00506922|P5|Participant Flow|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
606677|NCT00506922|P4|Participant Flow|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
606678|NCT00506922|P3|Participant Flow|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
606679|NCT00506922|P2|Participant Flow|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
606680|NCT00506922|P1|Participant Flow|No Pentostatin|Group 1: No Pentostatin
606681|NCT00506922|O1|Outcome|Pentostatin|150 patients were enrolled, 2 patients not treated, 38 patients were Group 1 (no Pentostatin), the remaining Groups 2,3,4 and 5, 110 patients were analysed that received the Pentostatin.
606682|NCT00506922|E5|Reported Event|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
606683|NCT00506922|E4|Reported Event|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
606684|NCT00506922|E3|Reported Event|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
606685|NCT00506922|E2|Reported Event|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
606686|NCT00506922|E1|Reported Event|No Pentostatin|Group 1: No Pentostatin
606687|NCT00506883|B4|Baseline|Total|Total of all reporting groups
606688|NCT00506883|B3|Baseline|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
606689|NCT00506883|B2|Baseline|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
606690|NCT00506883|B1|Baseline|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
606691|NCT00506883|P3|Participant Flow|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
606692|NCT00506883|P2|Participant Flow|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
606693|NCT00506883|P1|Participant Flow|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
606694|NCT00506883|O3|Outcome|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
606695|NCT00506883|O2|Outcome|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
606696|NCT00506883|O1|Outcome|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
606697|NCT00506883|E3|Reported Event|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
606698|NCT00506883|E2|Reported Event|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
606754|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
615767|NCT00483184|O2|Outcome|2|(Veldona)500 IU IFNα bid
606699|NCT00506883|E1|Reported Event|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
606700|NCT00506857|B1|Baseline|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
606701|NCT00506857|P1|Participant Flow|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
606702|NCT00506857|O1|Outcome|Tacrolimus + Methotrexate|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
606703|NCT00506857|O1|Outcome|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
606704|NCT00506857|E1|Reported Event|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
606705|NCT00506831|B1|Baseline|Imatinib Mesylate|
606706|NCT00506831|P1|Participant Flow|Imatinib Mesylate|
606707|NCT00506831|O1|Outcome|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
606708|NCT00506831|E1|Reported Event|Imatinib Mesylate|
606709|NCT00506714|B3|Baseline|Total|Total of all reporting groups
606710|NCT00506714|B2|Baseline|Group 2|Adults with symptomatic hip osteoarthritis
606711|NCT00506714|B1|Baseline|Group 1|Healthy adults
606712|NCT00506714|P2|Participant Flow|Group 2|Adults with symptomatic hip osteoarthritis
606713|NCT00506714|P1|Participant Flow|Group 1|Healthy adults
606714|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis after four weeks of cane use
606715|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking with a cane at baseline
606716|NCT00506714|O2|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking without a cane at baseline
606717|NCT00506714|O1|Outcome|Group 1|Healthy adults walking without a cane at baseline
606718|NCT00506714|E2|Reported Event|Group 2|Adults with symptomatic hip osteoarthritis
606719|NCT00506714|E1|Reported Event|Group 1|Healthy adults
606720|NCT00506675|B3|Baseline|Total|Total of all reporting groups
606721|NCT00506675|B2|Baseline|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
606722|NCT00506675|B1|Baseline|Intensive|6 hours daily patching combined with daily atropine
606723|NCT00506675|P2|Participant Flow|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
606724|NCT00506675|P1|Participant Flow|Intensive|6 hours daily patching combined with daily atropine
606725|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
606726|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
606727|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
606728|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
606729|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
606730|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
606731|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
606732|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
606733|NCT00506675|E2|Reported Event|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
606734|NCT00506675|E1|Reported Event|Intensive|6 hours daily patching combined with daily atropine
606735|NCT00506662|B3|Baseline|Total|Total of all reporting groups
606736|NCT00506662|B2|Baseline|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606737|NCT00506662|B1|Baseline|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606738|NCT00506662|P2|Participant Flow|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606739|NCT00506662|P1|Participant Flow|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606740|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606741|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606742|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606743|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606744|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606745|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606746|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606747|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606748|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606749|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606750|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606751|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606752|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606753|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606756|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606757|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606758|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606759|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606760|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606761|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606762|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606763|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606764|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606765|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606766|NCT00506662|E2|Reported Event|Insulin NPH|Individually adjusted dose of insulin NPH once daily
606767|NCT00506662|E1|Reported Event|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
606768|NCT00506597|B1|Baseline|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
606769|NCT00506597|P1|Participant Flow|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
606770|NCT00506597|O1|Outcome|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
606771|NCT00506597|E1|Reported Event|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
606772|NCT00506493|B1|Baseline|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
606773|NCT00506493|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
606774|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
606775|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
606776|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who underwent surgical ablation with the Cardioblate Surgical Ablation System.
606777|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
606778|NCT00506493|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
606779|NCT00506454|B3|Baseline|Total|Total of all reporting groups
606780|NCT00506454|B2|Baseline|Placebo|Participants receiving the placebo.
606781|NCT00506454|B1|Baseline|Active|Participants receiving the active drug.
606782|NCT00506454|P2|Participant Flow|Placebo|Participants receiving the placebo.
606783|NCT00506454|P1|Participant Flow|Active|Participants receiving the active drug.
606784|NCT00506454|O2|Outcome|Placebo|Participants receiving the placebo.
606785|NCT00506454|O1|Outcome|Treatment|Participants receiving the active drug.
606786|NCT00506454|E2|Reported Event|Placebo|Participants receiving the placebo.
606787|NCT00506454|E1|Reported Event|Active|Participants receiving the active drug.
606788|NCT00506441|B1|Baseline|MCI-196|"Open-label Period (Week 0 - 12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
606789|NCT00506441|P2|Participant Flow|Placebo|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
606790|NCT00506441|P1|Participant Flow|MCI-196|"Open-label Period (Week 0 -12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
606791|NCT00506441|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated (Week 0 -12)
606792|NCT00506441|O2|Outcome|Placebo (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
606793|NCT00506441|O1|Outcome|MCI-196 (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
606794|NCT00506441|E3|Reported Event|Placebo (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
606795|NCT00506441|E2|Reported Event|MCI-196 (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
606796|NCT00506441|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15 g/ day as titrated (Week 0-12)
606797|NCT00506415|B1|Baseline|Total Patients|Total number of patients enrolled in the initial open label period that may have been randomized in the double blind period or may have continued in the extended open label period.
606798|NCT00506415|P4|Participant Flow|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks (from week 48 to week 96) open label treatment.
606799|NCT00506415|P3|Participant Flow|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
615768|NCT00483184|O1|Outcome|1|(placebo)0 IU IFN alpha
606800|NCT00506415|P2|Participant Flow|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606801|NCT00506415|P1|Participant Flow|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
606802|NCT00506415|O4|Outcome|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.
606803|NCT00506415|O3|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15c m^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
606804|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606805|NCT00506415|O1|Outcome|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
606806|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
606807|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606808|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606809|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during the double blind period.
606810|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
606811|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606812|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
606813|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606814|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
606815|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606816|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
606817|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
606818|NCT00506415|E4|Reported Event|Extended Open Label: Rivastigmine (10 cm^2)|Safety population Extended Open Label (Safety-EOL) - This population consisted of all patients who received at least 1 dose of study drug during the extended open label phase and had at least 1 post baseline safety assessment during the same phase.
606819|NCT00506415|E3|Reported Event|Double Blind: Rivastigmine (15 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
606820|NCT00506415|E2|Reported Event|Double Blind: Rivastigmine (10 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
606821|NCT00506415|E1|Reported Event|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Safety population Initial Open Label (Safety-IOL) - This population consisted of all patients who received at least 1 dose of study drug during the initial open label phase and had at least 1 post baseline safety assessment during the same phase.
606822|NCT00506389|B4|Baseline|Total|Total of all reporting groups
606823|NCT00506389|B3|Baseline|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606824|NCT00506389|B2|Baseline|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606825|NCT00506389|B1|Baseline|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606826|NCT00506389|P3|Participant Flow|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606827|NCT00506389|P2|Participant Flow|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
607023|NCT00506077|B2|Baseline|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
607381|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
606828|NCT00506389|P1|Participant Flow|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606829|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606830|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606831|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606832|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606833|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606834|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606835|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606836|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606837|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
606838|NCT00506389|E6|Reported Event|Placebo Follow-up|After participants received placebo tablets during the Placebo Washout Period and placebo during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
606839|NCT00506389|E5|Reported Event|Esmirtazapine 4.5 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 4.5 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
606840|NCT00506389|E4|Reported Event|Esmirtazapine 3.0 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 3.0 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
606841|NCT00506389|E3|Reported Event|Placebo In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
606842|NCT00506389|E2|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
606843|NCT00506389|E1|Reported Event|Esmirtazapine 3.0 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
606844|NCT00506350|B10|Baseline|Total|Total of all reporting groups
606845|NCT00506350|B9|Baseline|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606846|NCT00506350|B8|Baseline|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606847|NCT00506350|B7|Baseline|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606848|NCT00506350|B6|Baseline|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
607024|NCT00506077|B1|Baseline|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
615769|NCT00483184|E3|Reported Event|3|(Veldona)1000 IU IFNα bid
606849|NCT00506350|B5|Baseline|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606850|NCT00506350|B4|Baseline|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606851|NCT00506350|B3|Baseline|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606852|NCT00506350|B2|Baseline|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606853|NCT00506350|B1|Baseline|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606854|NCT00506350|P9|Participant Flow|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606855|NCT00506350|P8|Participant Flow|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606856|NCT00506350|P7|Participant Flow|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606857|NCT00506350|P6|Participant Flow|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606858|NCT00506350|P5|Participant Flow|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606859|NCT00506350|P4|Participant Flow|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606860|NCT00506350|P3|Participant Flow|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606861|NCT00506350|P2|Participant Flow|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606862|NCT00506350|P1|Participant Flow|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606863|NCT00506350|O3|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606864|NCT00506350|O2|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
607025|NCT00506077|P2|Participant Flow|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
607026|NCT00506077|P1|Participant Flow|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
606865|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606866|NCT00506350|O3|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606867|NCT00506350|O2|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606868|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606869|NCT00506350|O9|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606870|NCT00506350|O8|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606871|NCT00506350|O7|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606872|NCT00506350|O6|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606873|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606874|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606875|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606876|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606877|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606878|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606879|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606880|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606881|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606882|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606883|NCT00506350|O9|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606884|NCT00506350|O8|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606885|NCT00506350|O7|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606886|NCT00506350|O6|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606887|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606888|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606889|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606890|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606891|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606892|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606893|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606894|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606895|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606896|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606897|NCT00506350|O3|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
607050|NCT00506064|O2|Outcome|Placebo|Starch capsules by mouth daily
607051|NCT00506064|O1|Outcome|Melatonin|0.15 mg/kg capsules by mouth daily
607052|NCT00506064|E2|Reported Event|Placebo|Starch capsules by mouth daily
607053|NCT00506064|E1|Reported Event|Melatonin|0.15 mg/kg capsules by mouth daily
606898|NCT00506350|O2|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606899|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606900|NCT00506350|O3|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606901|NCT00506350|O2|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606902|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606903|NCT00506350|O9|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606904|NCT00506350|O8|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606905|NCT00506350|O7|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606906|NCT00506350|O6|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606907|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606908|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606909|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606910|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606911|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606912|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606913|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606947|NCT00506350|O3|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606914|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606915|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606916|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606917|NCT00506350|O9|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606918|NCT00506350|O8|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606919|NCT00506350|O7|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606920|NCT00506350|O6|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606921|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606922|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606923|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606924|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606925|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606926|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606927|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606928|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606929|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
607054|NCT00506025|B4|Baseline|Total|Total of all reporting groups
607055|NCT00506025|B3|Baseline|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
606930|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606931|NCT00506350|O3|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606932|NCT00506350|O2|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606933|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606934|NCT00506350|O3|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606935|NCT00506350|O2|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606936|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606937|NCT00506350|O9|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606938|NCT00506350|O8|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606939|NCT00506350|O7|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606940|NCT00506350|O6|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606941|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606942|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606943|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606944|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606945|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606946|NCT00506350|O4|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606948|NCT00506350|O2|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606949|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606950|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606951|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606952|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606953|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606954|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606955|NCT00506350|O9|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606956|NCT00506350|O8|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606957|NCT00506350|O7|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606958|NCT00506350|O6|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606959|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606960|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606961|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606962|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606963|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
607019|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
606964|NCT00506350|O9|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606965|NCT00506350|O8|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606966|NCT00506350|O7|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606967|NCT00506350|O6|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606968|NCT00506350|O5|Outcome|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606969|NCT00506350|O4|Outcome|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606970|NCT00506350|O3|Outcome|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606971|NCT00506350|O2|Outcome|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
606972|NCT00506350|O1|Outcome|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
606973|NCT00506350|O4|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606974|NCT00506350|O3|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606975|NCT00506350|O2|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606976|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606977|NCT00506350|O4|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606978|NCT00506350|O3|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606979|NCT00506350|O2|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
607020|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
606980|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606981|NCT00506350|O4|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606982|NCT00506350|O3|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606983|NCT00506350|O2|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606984|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606985|NCT00506350|O4|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606986|NCT00506350|O3|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606987|NCT00506350|O2|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606988|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606989|NCT00506350|O4|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606990|NCT00506350|O3|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606991|NCT00506350|O2|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606992|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606993|NCT00506350|O4|Outcome|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606994|NCT00506350|O3|Outcome|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606995|NCT00506350|O2|Outcome|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
607021|NCT00506155|E1|Reported Event|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
606996|NCT00506350|O1|Outcome|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606997|NCT00506350|E9|Reported Event|GSK1562902A AD Approved F Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606998|NCT00506350|E8|Reported Event|GSK1562902A AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
606999|NCT00506350|E7|Reported Event|GSK1562902A AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
607000|NCT00506350|E6|Reported Event|GSK1562902A AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
607001|NCT00506350|E5|Reported Event|Control Group|Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
607002|NCT00506350|E4|Reported Event|GSK1562902A Non-AD F4 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
607003|NCT00506350|E3|Reported Event|GSK1562902A Non-AD F3 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
607004|NCT00506350|E2|Reported Event|GSK1562902A Non-AD F2 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
607005|NCT00506350|E1|Reported Event|GSK1562902A Non-AD F1 Primed Group|Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
607006|NCT00506285|B3|Baseline|Total|Total of all reporting groups
607007|NCT00506285|B2|Baseline|B Placebo Patch Was Used First|Placebo patch was used in the first treatment arm and MTS in the second treatment arm.
607008|NCT00506285|B1|Baseline|a) Methylphenidate Transdermal System Was Taken First|Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm
607009|NCT00506285|P2|Participant Flow|B) PBO Arm Was 1st and MTS Arm Was 2nd|Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
607010|NCT00506285|P1|Participant Flow|A) MTS Arm Was 1st and PBO Arm Was 2nd|MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
607011|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average CAARS score at end of placebo treatment
607012|NCT00506285|O1|Outcome|Scores in MTS Arm|Average CAARS score at end of active treatment
607013|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average WRAADDS scores at end of placebo arm
607014|NCT00506285|O1|Outcome|Scores in MTS Arm|Average WRAADDS scores at end of active treatment (MTS) arm
607015|NCT00506285|E2|Reported Event|Placebo Arm|Adverse events and Serious AEs during placebo arm
607016|NCT00506285|E1|Reported Event|MTS Arm|Adverse events and Serious AEs during active treatment (MTS) arm
607017|NCT00506155|B1|Baseline|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
607018|NCT00506155|P1|Participant Flow|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
607022|NCT00506077|B3|Baseline|Total|Total of all reporting groups
607422|NCT00504725|E2|Reported Event|Placebo|0.9 % saline bolus of equivalent volume
607027|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607028|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607029|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607030|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607031|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607032|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607033|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607034|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607035|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607036|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607037|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607038|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607039|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607040|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607041|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607042|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607043|NCT00506077|E2|Reported Event|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607044|NCT00506077|E1|Reported Event|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
607045|NCT00506064|B3|Baseline|Total|Total of all reporting groups
607046|NCT00506064|B2|Baseline|Placebo|Starch capsules by mouth daily
607047|NCT00506064|B1|Baseline|Melatonin|0.15 mg/kg capsules by mouth daily
607048|NCT00506064|P2|Participant Flow|Placebo|Starch capsules by mouth daily
607049|NCT00506064|P1|Participant Flow|Melatonin|0.15 mg/kg capsules by mouth daily
607056|NCT00506025|B2|Baseline|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
607057|NCT00506025|B1|Baseline|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
607058|NCT00506025|P3|Participant Flow|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
607059|NCT00506025|P2|Participant Flow|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
607060|NCT00506025|P1|Participant Flow|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
607061|NCT00506025|O3|Outcome|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
607062|NCT00506025|O2|Outcome|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
607063|NCT00506025|O1|Outcome|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
607064|NCT00506025|E3|Reported Event|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
607065|NCT00506025|E2|Reported Event|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
607066|NCT00506025|E1|Reported Event|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
607067|NCT00505934|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
607068|NCT00505934|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
607069|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
607070|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
607071|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
607072|NCT00505934|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
607073|NCT00505921|B1|Baseline|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
607103|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607104|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607105|NCT00505778|E2|Reported Event|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607106|NCT00505778|E1|Reported Event|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607074|NCT00505921|P1|Participant Flow|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
607075|NCT00505921|O1|Outcome|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
607076|NCT00505921|E1|Reported Event|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
607077|NCT00505895|B3|Baseline|Total|Total of all reporting groups
607078|NCT00505895|B2|Baseline|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5."
607079|NCT00505895|B1|Baseline|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607080|NCT00505895|P2|Participant Flow|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607081|NCT00505895|P1|Participant Flow|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607082|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607083|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607084|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607085|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607086|NCT00505895|E2|Reported Event|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607087|NCT00505895|E1|Reported Event|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
607088|NCT00505778|B3|Baseline|Total|Total of all reporting groups
607089|NCT00505778|B2|Baseline|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607090|NCT00505778|B1|Baseline|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607091|NCT00505778|P2|Participant Flow|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607092|NCT00505778|P1|Participant Flow|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607093|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607094|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607095|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607096|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607097|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607098|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607099|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607100|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607101|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
607102|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
607108|NCT00505765|B3|Baseline|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607109|NCT00505765|B2|Baseline|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607110|NCT00505765|B1|Baseline|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607111|NCT00505765|P3|Participant Flow|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607112|NCT00505765|P2|Participant Flow|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607113|NCT00505765|P1|Participant Flow|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607114|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607115|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607116|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607117|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607118|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607119|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607120|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607121|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607122|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607123|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607124|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607125|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607126|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607127|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607128|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607129|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607130|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607131|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607132|NCT00505765|E3|Reported Event|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
607133|NCT00505765|E2|Reported Event|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
607134|NCT00505765|E1|Reported Event|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
607135|NCT00505752|B5|Baseline|Total|Total of all reporting groups
607136|NCT00505752|B4|Baseline|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607137|NCT00505752|B3|Baseline|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607138|NCT00505752|B2|Baseline|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607139|NCT00505752|B1|Baseline|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607140|NCT00505752|P4|Participant Flow|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607141|NCT00505752|P3|Participant Flow|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607142|NCT00505752|P2|Participant Flow|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607143|NCT00505752|P1|Participant Flow|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607144|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607145|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607146|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607147|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607148|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607149|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607206|NCT00505414|O5|Outcome|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
608869|NCT00500682|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
607150|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607151|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607152|NCT00505752|E4|Reported Event|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607153|NCT00505752|E3|Reported Event|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607154|NCT00505752|E2|Reported Event|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607155|NCT00505752|E1|Reported Event|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
607156|NCT00505687|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
607157|NCT00505687|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
607158|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
607159|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
607160|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
607161|NCT00505687|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
607162|NCT00505661|B1|Baseline|Letrozole|2.5 mg by mouth (PO) daily
607163|NCT00505661|P1|Participant Flow|Letrozole|2.5 mg by mouth (PO) daily
607164|NCT00505661|O1|Outcome|Letrozole|2.5 mg by mouth (PO) daily
607165|NCT00505661|E1|Reported Event|Letrozole|2.5 mg by mouth (PO) daily
607166|NCT00505635|B1|Baseline|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
607167|NCT00505635|P1|Participant Flow|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
607168|NCT00505635|O1|Outcome|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
607169|NCT00505635|E1|Reported Event|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
607170|NCT00505622|B4|Baseline|Total|Total of all reporting groups
607171|NCT00505622|B3|Baseline|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607172|NCT00505622|B2|Baseline|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607173|NCT00505622|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607174|NCT00505622|P3|Participant Flow|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607175|NCT00505622|P2|Participant Flow|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607176|NCT00505622|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607177|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607178|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607179|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607180|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607181|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607182|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607183|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607184|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607282|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607185|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607186|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607187|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607188|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607189|NCT00505622|E3|Reported Event|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607190|NCT00505622|E2|Reported Event|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607191|NCT00505622|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
607192|NCT00505518|B1|Baseline|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
607193|NCT00505518|P1|Participant Flow|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
607194|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
607195|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
607196|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
607197|NCT00505518|E1|Reported Event|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
607198|NCT00505414|B3|Baseline|Total|Total of all reporting groups
607199|NCT00505414|B2|Baseline|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
607200|NCT00505414|B1|Baseline|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
607201|NCT00505414|P5|Participant Flow|Morphine (Titration Phase)|After signing informed consent eligible participants were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
607202|NCT00505414|P4|Participant Flow|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg up to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
607203|NCT00505414|P3|Participant Flow|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
607204|NCT00505414|P2|Participant Flow|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
607205|NCT00505414|P1|Participant Flow|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
609315|NCT00499746|E1|Reported Event|All Participants|
607207|NCT00505414|O4|Outcome|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
607208|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
607209|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
607210|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
607211|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
607212|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
607213|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
607214|NCT00505414|E5|Reported Event|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
607215|NCT00505414|E4|Reported Event|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
607216|NCT00505414|E3|Reported Event|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
607217|NCT00505414|E2|Reported Event|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
607218|NCT00505414|E1|Reported Event|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
607219|NCT00505375|B3|Baseline|Total|Total of all reporting groups
607220|NCT00505375|B2|Baseline|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
607221|NCT00505375|B1|Baseline|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
607222|NCT00505375|P2|Participant Flow|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
607223|NCT00505375|P1|Participant Flow|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
607224|NCT00505375|O2|Outcome|Placebo|Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
607225|NCT00505375|O1|Outcome|CTLA-4 Ig|Intravenous infusions 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
607226|NCT00505375|E2|Reported Event|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
607227|NCT00505375|E1|Reported Event|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
607228|NCT00505362|B3|Baseline|Total|Total of all reporting groups
607229|NCT00505362|B2|Baseline|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
607230|NCT00505362|B1|Baseline|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
607231|NCT00505362|P2|Participant Flow|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
607232|NCT00505362|P1|Participant Flow|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
607233|NCT00505362|O2|Outcome|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
607234|NCT00505362|O1|Outcome|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
607235|NCT00505362|O2|Outcome|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
607283|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607284|NCT00505284|O1|Outcome|Placebo|
607236|NCT00505362|O1|Outcome|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
607237|NCT00505362|E2|Reported Event|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
607238|NCT00505362|E1|Reported Event|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
607239|NCT00505284|B6|Baseline|Total|Total of all reporting groups
607240|NCT00505284|B5|Baseline|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607241|NCT00505284|B4|Baseline|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607242|NCT00505284|B3|Baseline|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607243|NCT00505284|B2|Baseline|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607244|NCT00505284|B1|Baseline|Placebo|
607245|NCT00505284|P5|Participant Flow|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607246|NCT00505284|P4|Participant Flow|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607247|NCT00505284|P3|Participant Flow|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607248|NCT00505284|P2|Participant Flow|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607249|NCT00505284|P1|Participant Flow|Placebo|
607250|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607251|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607252|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607253|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607254|NCT00505284|O1|Outcome|Placebo|
607255|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607256|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607257|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607258|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607259|NCT00505284|O1|Outcome|Placebo|
607260|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607261|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607262|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607263|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607264|NCT00505284|O1|Outcome|Placebo|
607265|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607266|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607267|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607268|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607269|NCT00505284|O1|Outcome|Placebo|
607270|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607271|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607272|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607273|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607274|NCT00505284|O1|Outcome|Placebo|
607275|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607276|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607277|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607278|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607279|NCT00505284|O1|Outcome|Placebo|
607280|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607281|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607285|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607286|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607287|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607288|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607289|NCT00505284|O1|Outcome|Placebo|
607290|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607291|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607292|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607293|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607294|NCT00505284|O1|Outcome|Placebo|
607295|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607296|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607297|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607298|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607299|NCT00505284|O1|Outcome|Placebo|
607300|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607301|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607302|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607303|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607304|NCT00505284|O1|Outcome|Placebo|
607305|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607306|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607307|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607308|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607309|NCT00505284|O1|Outcome|Placebo|
607310|NCT00505284|E5|Reported Event|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
607311|NCT00505284|E4|Reported Event|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
607312|NCT00505284|E3|Reported Event|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
607313|NCT00505284|E2|Reported Event|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
607314|NCT00505284|E1|Reported Event|Placebo|
607315|NCT00505076|B4|Baseline|Total|Total of all reporting groups
607316|NCT00505076|B3|Baseline|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
607317|NCT00505076|B2|Baseline|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
607318|NCT00505076|B1|Baseline|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
607319|NCT00505076|P3|Participant Flow|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
607320|NCT00505076|P2|Participant Flow|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
607321|NCT00505076|P1|Participant Flow|MK-0777 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
607322|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
607323|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
607324|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
607325|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
607326|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
607327|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
607328|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
607329|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
607330|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
607331|NCT00505076|E3|Reported Event|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
607332|NCT00505076|E2|Reported Event|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
607333|NCT00505076|E1|Reported Event|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
607334|NCT00504985|B1|Baseline|Fatigue in Emergency Center Patients|
607335|NCT00504985|P1|Participant Flow|Fatigue in Emergency Center Patients|
607336|NCT00504985|O1|Outcome|Fatigue in Emergency Center Patients|
607337|NCT00504985|E1|Reported Event|Fatigue in Emergency Center Patients|
607338|NCT00504894|B3|Baseline|Total|Total of all reporting groups
607380|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607339|NCT00504894|B2|Baseline|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
607340|NCT00504894|B1|Baseline|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
607341|NCT00504894|P2|Participant Flow|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
607342|NCT00504894|P1|Participant Flow|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
607343|NCT00504894|O2|Outcome|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
607344|NCT00504894|O1|Outcome|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
607345|NCT00504894|E2|Reported Event|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
607346|NCT00504894|E1|Reported Event|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
607347|NCT00504881|B3|Baseline|Total Title|
607348|NCT00504881|B2|Baseline|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607349|NCT00504881|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
607350|NCT00504881|P2|Participant Flow|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607351|NCT00504881|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
607352|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607353|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607354|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607355|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607356|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607357|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607358|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607359|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607360|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607361|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607362|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607363|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607364|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607365|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607366|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607367|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607368|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607369|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607370|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607371|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607372|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607373|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607374|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607375|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607376|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607377|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607378|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607379|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607382|NCT00504881|O2|Outcome|Brivaracetam|"A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day~Brivaracetam: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period"
607383|NCT00504881|O1|Outcome|Placebo|"Matching Placebo tablets administered twice a day~Placebo: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period"
607384|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607385|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607386|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607387|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607388|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607389|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607390|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607391|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607392|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607393|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607394|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607395|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607396|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607397|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
607398|NCT00504881|E2|Reported Event|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
607399|NCT00504881|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
607400|NCT00504777|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV, and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
607401|NCT00504777|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
607402|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
607403|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
607404|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
607405|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
607406|NCT00504777|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
607407|NCT00504751|B1|Baseline|Study Treatment|This is a single arm study
607408|NCT00504751|P1|Participant Flow|Study Treatment|"This is a single arm study~bortezomib, dexamethasone, ifosfamide: VIPER chemotherapy will be administered every 28 days at the following doses:~Dexamethasone 40 mg IV days 1-4~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)~Cisplatin 25 mg IV days 1-4~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)~VELCADE 1.5 mg/m2 on days 2 and 5~mesna, cisplatin, etoposide, rituximab: VIPER chemotherapy will be administered every 28 days at the following doses:~Dexamethasone 40 mg IV days 1-4~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)~Cisplatin 25 mg IV days 1-4~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)~VELCADE 1.5"
607409|NCT00504751|O1|Outcome|Study Treatment|This is a single arm study
607410|NCT00504751|E1|Reported Event|Study Treatment|This is a single arm study
607411|NCT00504725|B3|Baseline|Total|Total of all reporting groups
607412|NCT00504725|B2|Baseline|Placebo|0.9 % saline bolus of equivalent volume
607413|NCT00504725|B1|Baseline|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
607414|NCT00504725|P2|Participant Flow|Placebo|0.9 % saline bolus of equivalent volume
607415|NCT00504725|P1|Participant Flow|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
607416|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
607417|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
607418|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
607419|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
607420|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
607421|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
607423|NCT00504725|E1|Reported Event|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
607424|NCT00504660|B3|Baseline|Total|Total of all reporting groups
607425|NCT00504660|B2|Baseline|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
607426|NCT00504660|B1|Baseline|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
607427|NCT00504660|P2|Participant Flow|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
607428|NCT00504660|P1|Participant Flow|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
607429|NCT00504660|O1|Outcome|Participants With Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
607430|NCT00504660|O1|Outcome|Participants With Recurrent Anaplastic Glioma|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Capecitabine 825 mg/m^2 and Celebrex 400 mg PO every 12 hours; Arm 1 Temozolomide (TMZ) 150 mg/m^2 PO daily Days 4-8 OR Arm 2 Lomustine 100 mg/m^2 PO on Day 4; Arm 2 Participants if previously received Temozolomide but not Lomustine (CCNU) receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) receive Temozolomide.
607431|NCT00504660|E2|Reported Event|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
607432|NCT00504660|E1|Reported Event|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
607433|NCT00504595|B5|Baseline|Total|Total of all reporting groups
607434|NCT00504595|B4|Baseline|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
607435|NCT00504595|B3|Baseline|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
607436|NCT00504595|B2|Baseline|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
607437|NCT00504595|B1|Baseline|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
607438|NCT00504595|P4|Participant Flow|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
607439|NCT00504595|P3|Participant Flow|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
607440|NCT00504595|P2|Participant Flow|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
607441|NCT00504595|P1|Participant Flow|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
607442|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
607443|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
607444|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Patients with Rheumatoid Arthritis (RA) who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
607445|NCT00504595|O1|Outcome|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis (RA) taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
607446|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
607447|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
607448|NCT00504595|E4|Reported Event|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
607449|NCT00504595|E3|Reported Event|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
607450|NCT00504595|E2|Reported Event|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
607451|NCT00504595|E1|Reported Event|ACZ885 (Canakinumab): Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1.
607452|NCT00504556|B6|Baseline|Total|Total of all reporting groups
607453|NCT00504556|B5|Baseline|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607454|NCT00504556|B4|Baseline|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607455|NCT00504556|B3|Baseline|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607456|NCT00504556|B2|Baseline|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607457|NCT00504556|B1|Baseline|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607458|NCT00504556|P5|Participant Flow|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607459|NCT00504556|P4|Participant Flow|DU-176b 60mg Bid|"DU-176b 60mg tablets two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607460|NCT00504556|P3|Participant Flow|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607461|NCT00504556|P2|Participant Flow|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607462|NCT00504556|P1|Participant Flow|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607463|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607464|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607465|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607466|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607467|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607468|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607469|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607470|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607471|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607472|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607473|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607474|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607475|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607476|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607477|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607478|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607479|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607480|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607481|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607482|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607483|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607484|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607485|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607486|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607487|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607488|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607489|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607490|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607491|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607492|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607493|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607494|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607495|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607496|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607497|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607498|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607499|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607500|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607501|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607502|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607503|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607504|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607505|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607506|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607507|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607508|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607509|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607510|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607511|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607512|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607513|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607514|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607515|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607516|NCT00504556|E5|Reported Event|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
607517|NCT00504556|E4|Reported Event|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
607518|NCT00504556|E3|Reported Event|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
607519|NCT00504556|E2|Reported Event|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
607520|NCT00504556|E1|Reported Event|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
607521|NCT00504504|B1|Baseline|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
607522|NCT00504504|P1|Participant Flow|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
607523|NCT00504504|O1|Outcome|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
607524|NCT00504504|E1|Reported Event|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
607525|NCT00504426|B5|Baseline|Total|Total of all reporting groups
607526|NCT00504426|B4|Baseline|OPC-249 (120IU)|120 IU of OPC-249/vial
607527|NCT00504426|B3|Baseline|OPC-249 (60IU)|60 IU of OPC-249/vial
607528|NCT00504426|B2|Baseline|OPC-249 (30IU)|30 IU of OPC-249/vial
607529|NCT00504426|B1|Baseline|Placebo|Placebo of OPC-249/vial
607530|NCT00504426|P4|Participant Flow|OPC-249 (120IU)|120 IU of OPC-249/vial
607531|NCT00504426|P3|Participant Flow|OPC-249 (60IU)|60 IU of OPC-249/vial
607532|NCT00504426|P2|Participant Flow|OPC-249 (30IU)|30 IU of OPC-249/vial
607533|NCT00504426|P1|Participant Flow|Placebo|Placebo of OPC-249/vial
607534|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249/vial
607535|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249/vial
607536|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249/vial
607537|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
607538|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249 /vial
607539|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249 /vial
607540|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249 /vial
607541|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
607542|NCT00504426|E4|Reported Event|OPC-249 (120IU)|120 IU of OPC-249/vial
607543|NCT00504426|E3|Reported Event|OPC-249 (60IU)|60 IU of OPC-249/vial
607544|NCT00504426|E2|Reported Event|OPC-249 (30IU)|30 IU of OPC-249/vial
607545|NCT00504426|E1|Reported Event|Placebo|Placebo of OPC-249/vial
607546|NCT00504309|B7|Baseline|Total|Total of all reporting groups
607547|NCT00504309|B6|Baseline|Placebo, 1 g P-OM3, 4 g P-OM3|4 g/d corn oil placebo for 8 weeks, followed by 1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks
607548|NCT00504309|B5|Baseline|1 g P-OM3, Placebo, 4 g P-OM3|1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks
607549|NCT00504309|B4|Baseline|4 g P-OM3, Placebo, 1 g P-OM3|4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks
607550|NCT00504309|B3|Baseline|Placebo, 4 g P-OM3, 1 g P-OM3|4 g/d corn oil placebo for 8 weeks, followed by 4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks
607551|NCT00504309|B2|Baseline|1 g P-OM3, 4 g P-OM3, Placebo|1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks
607552|NCT00504309|B1|Baseline|4 g P-OM3, 1 g P-OM3, Placebo|4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks
607553|NCT00504309|P6|Participant Flow|Placebo, Then 1g P-OM3, Then 4g P-OM3|Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks
607554|NCT00504309|P5|Participant Flow|1g P-OM3, Then Placebo, Then 4g P-OM3|1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
607555|NCT00504309|P4|Participant Flow|4g P-OM3, Then Placebo, Then 1g P-OM3|4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks
607556|NCT00504309|P3|Participant Flow|Placebo, Then 4g P-OM3, Then 1g P-OM3|Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks
607557|NCT00504309|P2|Participant Flow|1g P-OM3, Then 4g P-OM3, Then Placebo|1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks
607558|NCT00504309|P1|Participant Flow|4g P-OM3, Then 1g P-OM3, Then Placebo|4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks)
607559|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607560|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607561|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607562|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607563|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607564|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607565|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607566|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607567|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607568|NCT00504309|O3|Outcome|Placebo|4 g/d corn Oil Placebo
607569|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607570|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607571|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607572|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607573|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607574|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607575|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607576|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607577|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607578|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607579|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607580|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607581|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607582|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607583|NCT00504309|O3|Outcome|Placebo|Corn Oil Placebo
607584|NCT00504309|O2|Outcome|1g P-OM3|1 g Prescription Omega-3 acid ethyl esters (P-OM3)
607585|NCT00504309|O1|Outcome|4g P-OM3|4 g Prescription Omega-3 acid ethyl esters (P-OM3)
607586|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607587|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607588|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607589|NCT00504309|O3|Outcome|Placebo|4 g/d corn oil placebo
607590|NCT00504309|O2|Outcome|1g P-OM3|1 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607591|NCT00504309|O1|Outcome|4g P-OM3|4 g/d Prescription Omega-3 acid ethyl esters (P-OM3)
607592|NCT00504309|E3|Reported Event|Placebo|Corn oil placebo
607593|NCT00504309|E2|Reported Event|1g P-OM3|1 g Prescription Omega-3 acid ethyl esters (P-OM3)
607594|NCT00504309|E1|Reported Event|4g P-OM3|4 g Prescription Omega-3 acid ethyl esters (P-OM3)
607595|NCT00504257|B1|Baseline|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607596|NCT00504257|P1|Participant Flow|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607597|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607598|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607599|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607600|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607645|NCT00504075|B1|Baseline|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
615770|NCT00483184|E2|Reported Event|2|(Veldona)500 IU IFNα bid
607601|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607602|NCT00504257|E1|Reported Event|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
607603|NCT00504231|B5|Baseline|Total|Total of all reporting groups
607604|NCT00504231|B4|Baseline|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
607605|NCT00504231|B3|Baseline|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
607606|NCT00504231|B2|Baseline|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
607607|NCT00504231|B1|Baseline|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
607608|NCT00504231|P4|Participant Flow|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
607609|NCT00504231|P3|Participant Flow|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
607610|NCT00504231|P2|Participant Flow|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
607611|NCT00504231|P1|Participant Flow|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
607612|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
607613|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
607614|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
607615|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
607616|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
607617|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
607618|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
607619|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
607620|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
607621|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
607622|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
607623|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
607624|NCT00504231|E4|Reported Event|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
607625|NCT00504231|E3|Reported Event|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
607626|NCT00504231|E2|Reported Event|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
607627|NCT00504231|E1|Reported Event|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
607628|NCT00504166|B3|Baseline|Total|Total of all reporting groups
607629|NCT00504166|B2|Baseline|Placebo|placebo to match alendronate sodium
607630|NCT00504166|B1|Baseline|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
607631|NCT00504166|P2|Participant Flow|Placebo|placebo to match alendronate sodium
607632|NCT00504166|P1|Participant Flow|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
607633|NCT00504166|O2|Outcome|Placebo Treatment|daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
607634|NCT00504166|O1|Outcome|Alendronate Treatment|70 mg of alendronate once weekly and daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
607635|NCT00504166|E2|Reported Event|Placebo|placebo to match alendronate sodium
607636|NCT00504166|E1|Reported Event|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
607637|NCT00504153|B1|Baseline|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
607638|NCT00504153|P1|Participant Flow|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
607639|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
607640|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
607641|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
607642|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
607643|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
607644|NCT00504153|E1|Reported Event|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
615771|NCT00483184|E1|Reported Event|1|(placebo)0 IU IFN alpha
607646|NCT00504075|P1|Participant Flow|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
607647|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
607648|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of Gammaplex was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
607649|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
607650|NCT00504075|E1|Reported Event|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
607651|NCT00504023|B1|Baseline|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget’s disease (EMPD).
607652|NCT00504023|P1|Participant Flow|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget’s disease (EMPD).
607653|NCT00504023|O1|Outcome|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget’s disease (EMPD).
607654|NCT00504023|E1|Reported Event|Imiquimod|This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget’s disease (EMPD).
607655|NCT00503997|B1|Baseline|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
607656|NCT00503997|P1|Participant Flow|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
607657|NCT00503997|O1|Outcome|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
607658|NCT00503997|E1|Reported Event|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
607659|NCT00503984|B3|Baseline|Total|Total of all reporting groups
607660|NCT00503984|B2|Baseline|Phase 2|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
607661|NCT00503984|B1|Baseline|Phase 1|"All Phase 1 participants who received at least one dose of the combination of Azacitidine (Aza) and Docetaxel (Doc) and 5mg of Prednisone at one of the starting dose levels:~Level 1: 75 mg/m2 Aza + 60 mg/m2 Doc~Level 2: 75 mg/m2 Aza + 75 mg/m2 Doc~Level 3: 100 mg/m2 Aza + 75 mg/m2 Doc~Level 4: 150 mg/m2 Aza + 75 mg/m2 Doc"
607662|NCT00503984|P6|Participant Flow|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
607663|NCT00503984|P5|Participant Flow|Phase 2 - Aza + Doc Initial RPTD|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
607664|NCT00503984|P4|Participant Flow|Phase 1: Level 4 - 150 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 4 dose combination of 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5 mg of Prednisone.
607665|NCT00503984|P3|Participant Flow|Phase 1: Level 3 - 100 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 3 dose combination of 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
607666|NCT00503984|P2|Participant Flow|Phase 1: Level 2 - 75 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 2 dose combination of 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
607667|NCT00503984|P1|Participant Flow|Phase 1: Level 1 - 75 Aza + 60 Doc|All Phase 1 participants who received at least one dose starting at the Level 1 dose combination of 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
607668|NCT00503984|O4|Outcome|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
607669|NCT00503984|O3|Outcome|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
607670|NCT00503984|O2|Outcome|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
607671|NCT00503984|O1|Outcome|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
607672|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
607673|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
607674|NCT00503984|O1|Outcome|All Study Participants Achieving PSA Response|All study participants who achieved PSA response to protocol therapy. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
607719|NCT00503776|B4|Baseline|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
607675|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Initial Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
607676|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 4: 150 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607677|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607678|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607679|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m2 of Azacitidine (Aza), 60 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607680|NCT00503984|O6|Outcome|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
607681|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
607682|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 1: 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607683|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607684|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607685|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
607686|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
607687|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
607688|NCT00503984|E4|Reported Event|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
607689|NCT00503984|E3|Reported Event|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
607690|NCT00503984|E2|Reported Event|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
607691|NCT00503984|E1|Reported Event|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
607692|NCT00503906|B1|Baseline|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607693|NCT00503906|P1|Participant Flow|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607694|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607695|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.~Avastin~Gemcitabine~Abraxane"
607696|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607697|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607698|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607699|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607700|NCT00503906|E1|Reported Event|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
607701|NCT00503880|B1|Baseline|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
607702|NCT00503880|P5|Participant Flow|Phase II: Clinical Response|The presence of hematologic response is the outcome of interest in the Phase II component of the study. Clinical Response will include complete response and partial response.
607703|NCT00503880|P4|Participant Flow|Phase I: Cohort #4|Clofarabine Level +3: 30 mg/m2
607704|NCT00503880|P3|Participant Flow|Phase 1: Dose Cohort #3|Clofarabine Level +2: 20mg/m2
607705|NCT00503880|P2|Participant Flow|Phase I: Cohort #2|Clofarabine Dose Level +1: 15 mg/m2
607706|NCT00503880|P1|Participant Flow|Phase I: Cohort #1|Clofarabine Dose Level 0: 10mg/m2
607707|NCT00503880|O1|Outcome|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
607708|NCT00503880|O1|Outcome|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
607709|NCT00503880|O1|Outcome|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
607710|NCT00503880|O1|Outcome|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
607711|NCT00503880|O1|Outcome|Treatment|G-CSF 300 μg subcutaneously to begin one day prior to treatment and continued until ANC greater than 1.0 or recovers back to the patients baseline ANC for 3 days in a row subsequent to completion of chemotherapy (SOC) Low-dose Cytarabine 10 mg/m2 subcutaneously daily starting on day 1 for the first 5 consecutive days of the treatment course 2-4 hours following the end of the clofarabine infusion. (SOC) Clofarabine starting at dose level 0: dose-10 mg/m2 IV over 1 hour daily starting on day 1 for the first 5 consecutive days of the treatment course.
607712|NCT00503880|O1|Outcome|Treatment|G-CSF 300 μg subcutaneously to begin one day prior to treatment and continued until ANC greater than 1.0 or recovers back to the patients baseline ANC for 3 days in a row subsequent to completion of chemotherapy (SOC) Low-dose Cytarabine 10 mg/m2 subcutaneously daily starting on day 1 for the first 5 consecutive days of the treatment course 2-4 hours following the end of the clofarabine infusion. (SOC) Clofarabine starting at dose level 0(Table 1) dose-10 mg/m2 IV over 1 hour daily starting on day 1 for the first 5 consecutive days of the treatment course.
607713|NCT00503880|E1|Reported Event|Treatment|"clofarabine: single IV dose over 1 hour daily for 5 days~cytarabine: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion~microarray analysis: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are adequate to assess responses.~biopsy: bone marrow biopsy"
607714|NCT00503841|B1|Baseline|Erlotinib Hydrochloride|If participants would have went onto study they would receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
607715|NCT00503841|P1|Participant Flow|Erlotinib Hydrochloride|"If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis~Treatment continues in the absence of disease progression or unacceptable toxicity.~Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)"
607716|NCT00503841|O1|Outcome|Erlotinib Hydrochloride|Patients must be willing to consider treatment with erlotinib, in the event they are eligible for the treatment phase of the study. Erlotinib (Tarceva®) will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent erlotinib (Tarceva®), at a dose of 150 mg/day mg by mouth. Patients will be instructed to take tablets once daily. The day of planned surgical resection of the invasive breast cancer will be considered day 0. Patients will undergo baseline physical examination and performance status evaluation on or before day -14. Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.
607717|NCT00503841|E1|Reported Event|Erlotinib Hydrochloride|Patients will be instructed to take tablets once daily.Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.The day of planned surgical resection of the invasive breast cancer will be considered day 0.
607718|NCT00503776|B5|Baseline|Total|Total of all reporting groups
607720|NCT00503776|B3|Baseline|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
607721|NCT00503776|B2|Baseline|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
607722|NCT00503776|B1|Baseline|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
607723|NCT00503776|P4|Participant Flow|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
607724|NCT00503776|P3|Participant Flow|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
607725|NCT00503776|P2|Participant Flow|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
607726|NCT00503776|P1|Participant Flow|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
607727|NCT00503776|O4|Outcome|Arm IIB|"Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.~exercise intervention: Patients undergo low weight resistance training.~amifostine trihydrate: Given subcutaneously~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607728|NCT00503776|O3|Outcome|Arm IIA|"Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.~amifostine trihydrate: Given subcutaneously~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607729|NCT00503776|O2|Outcome|Arm IB|"Patients undergo SNT and low weight resistance training (LWRT).~exercise intervention: Patients undergo low weight resistance training.~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607730|NCT00503776|O1|Outcome|Arm IA|"Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607731|NCT00503776|O4|Outcome|Arm IIB|"Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.~exercise intervention: Patients undergo low weight resistance training.~amifostine trihydrate: Given subcutaneously~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607732|NCT00503776|O3|Outcome|Arm IIA|"Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.~amifostine trihydrate: Given subcutaneously~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607733|NCT00503776|O2|Outcome|Arm IB|"Patients undergo SNT and low weight resistance training (LWRT).~exercise intervention: Patients undergo low weight resistance training.~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607734|NCT00503776|O1|Outcome|Arm IA|"Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.~therapeutic dietary intervention: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction."
607735|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
607736|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
607737|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
607738|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
607739|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
607740|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
607741|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
607742|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
607743|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
607744|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
607745|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low-weight resistance training (LWRT).
607746|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
607747|NCT00503776|E4|Reported Event|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
607748|NCT00503776|E3|Reported Event|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
607749|NCT00503776|E2|Reported Event|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
607750|NCT00503776|E1|Reported Event|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
607775|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607776|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607751|NCT00503750|B1|Baseline|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
607752|NCT00503750|P1|Participant Flow|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
607753|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
607754|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
607755|NCT00503750|E1|Reported Event|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
607756|NCT00503698|B3|Baseline|Total|Total of all reporting groups
607757|NCT00503698|B2|Baseline|Placebo|Placebo once daily, week 0 to end of trial
607758|NCT00503698|B1|Baseline|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607759|NCT00503698|P2|Participant Flow|Placebo|Placebo once daily, week 0 to end of trial
607760|NCT00503698|P1|Participant Flow|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607761|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
607762|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607763|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
607764|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607765|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
607766|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607767|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
607768|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607769|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
607770|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607771|NCT00503698|E2|Reported Event|Placebo|Placebo once daily, week 0 to end of trial
607772|NCT00503698|E1|Reported Event|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
607773|NCT00503425|B1|Baseline|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607774|NCT00503425|P1|Participant Flow|Rituximab|Participants received rituximab (MabThera) 1000 milligrams (mg) intravenous (IV) dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the European League Against Rheumatism (EULAR) response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607777|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607778|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607779|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607780|NCT00503425|E1|Reported Event|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
607781|NCT00503399|B3|Baseline|Total|Total of all reporting groups
607782|NCT00503399|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607783|NCT00503399|B1|Baseline|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607784|NCT00503399|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607785|NCT00503399|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607786|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607787|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607788|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607789|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607790|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607791|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607792|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607793|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607794|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607795|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607796|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607797|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607798|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607799|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607800|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607801|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607802|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607803|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607804|NCT00503399|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
607805|NCT00503399|E1|Reported Event|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
607806|NCT00503308|B3|Baseline|Total|Total of all reporting groups
607807|NCT00503308|B2|Baseline|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
607808|NCT00503308|B1|Baseline|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
607809|NCT00503308|P2|Participant Flow|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
607810|NCT00503308|P1|Participant Flow|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
607811|NCT00503308|O2|Outcome|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
607812|NCT00503308|O1|Outcome|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
607813|NCT00503308|E2|Reported Event|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
607814|NCT00503308|E1|Reported Event|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
607815|NCT00503139|B1|Baseline|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607816|NCT00503139|P1|Participant Flow|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607817|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607818|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607819|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607820|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607821|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607822|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607823|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607824|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607825|NCT00503139|E1|Reported Event|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
607826|NCT00503113|B4|Baseline|Total|Total of all reporting groups
607827|NCT00503113|B3|Baseline|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607828|NCT00503113|B2|Baseline|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607829|NCT00503113|B1|Baseline|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607830|NCT00503113|P3|Participant Flow|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607831|NCT00503113|P2|Participant Flow|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607832|NCT00503113|P1|Participant Flow|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607833|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607834|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607835|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607836|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607837|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607838|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607839|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607840|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607841|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607842|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607843|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607844|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607845|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607846|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607847|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607848|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607849|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607850|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607851|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607852|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607853|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607854|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607855|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607856|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607857|NCT00503113|E3|Reported Event|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
607858|NCT00503113|E2|Reported Event|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
607859|NCT00503113|E1|Reported Event|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
607860|NCT00503009|B4|Baseline|Total|Total of all reporting groups
607861|NCT00503009|B3|Baseline|Placebo Diskus BID|Placebo twice daily
607862|NCT00503009|B2|Baseline|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
607863|NCT00503009|B1|Baseline|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
607864|NCT00503009|P3|Participant Flow|Placebo Diskus BID|Placebo twice daily
607865|NCT00503009|P2|Participant Flow|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
607866|NCT00503009|P1|Participant Flow|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
607867|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
607868|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
607869|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
607870|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
607871|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
607872|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
607873|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
607874|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
607875|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
607876|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
607877|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
607878|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
607879|NCT00503009|E3|Reported Event|Placebo Diskus BID|Placebo twice daily
607880|NCT00503009|E2|Reported Event|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
607881|NCT00503009|E1|Reported Event|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
607882|NCT00502996|B1|Baseline|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607883|NCT00502996|P1|Participant Flow|Rituximab|Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607884|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607885|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607886|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607887|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607888|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607889|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607890|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607891|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607892|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607893|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607922|NCT00502905|P1|Participant Flow|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
607894|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607895|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607896|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607897|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607898|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607899|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607900|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607901|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607902|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607903|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607904|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607905|NCT00502996|E1|Reported Event|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
607906|NCT00502944|B3|Baseline|Total|Total of all reporting groups
607907|NCT00502944|B2|Baseline|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
607908|NCT00502944|B1|Baseline|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
607909|NCT00502944|P2|Participant Flow|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
607910|NCT00502944|P1|Participant Flow|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
607911|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
607912|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
607913|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
607914|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
607915|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
607916|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
607917|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
607918|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
607919|NCT00502944|E2|Reported Event|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
607920|NCT00502944|E1|Reported Event|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
607921|NCT00502905|B1|Baseline|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
607923|NCT00502905|O1|Outcome|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
607924|NCT00502905|E1|Reported Event|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
607925|NCT00502853|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607926|NCT00502853|P1|Participant Flow|Rituximab Plus (+) Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg per week (mg/week) by mouth or parenterally. Nonresponsive participants (defined as Disease Activity Score Based on 28-Joint Count and C-Reactive Protein [DAS28-CRP] score of greater than [>]2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607927|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607928|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607929|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received 1000 mg of Rituximab by IV infusion on Days 1 and 15 (considered to be one cycle). Participants also received 10-25 mg/week stable concomitant MTX by mouth or parenterally. Additional cycles of 2 infusions each could be administered provided the following: a minimum of 24 weeks had passed since the first infusion of the last course of study medication; the participant had a DAS28-CRP score of >2.6; the participant had a neutrophil count not below 1.5x10^3/μL; there was an absence of significant cardiac or pulmonary disease, primary or secondary immunodeficiency, and infections.
607930|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607931|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607932|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607933|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607934|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607935|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607936|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607937|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607938|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607939|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607940|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607941|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607942|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607943|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607944|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607945|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607946|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607947|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607948|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607949|NCT00502853|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
607950|NCT00502840|B1|Baseline|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
607951|NCT00502840|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 milligrams (mg) weekly; participants may also have been receiving a stable dose of folic acid. Participants with Disease Activity Score Based on 28 Joint Count (DAS28) greater than or equal to (≥)2.6 and an improvement in DAS28 greater than (>0.6) 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
607952|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607953|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607988|NCT00502775|P2|Participant Flow|Fluticasone Furoate 110mcg|
607989|NCT00502775|P1|Participant Flow|Placebo|
607990|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
607991|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
607992|NCT00502775|O1|Outcome|Placebo|
607993|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
607994|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
607954|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607955|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607956|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607957|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607958|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607959|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607960|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607961|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607962|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607963|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607964|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607965|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607966|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607995|NCT00502775|O1|Outcome|Placebo|
607967|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607968|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607969|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607970|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607971|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607972|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607973|NCT00502840|O1|Outcome|Rituximab Pluse MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607974|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607975|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607976|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607977|NCT00502840|E1|Reported Event|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
607978|NCT00502801|B1|Baseline|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
607979|NCT00502801|P1|Participant Flow|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
607980|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
607981|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
607982|NCT00502801|E1|Reported Event|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
607983|NCT00502775|B4|Baseline|Total|Total of all reporting groups
607984|NCT00502775|B3|Baseline|Fexofenadine 180 mg|
607985|NCT00502775|B2|Baseline|Fluticasone Furoate 110mcg|
607986|NCT00502775|B1|Baseline|Placebo|
607987|NCT00502775|P3|Participant Flow|Fexofenadine 180 mg|
608030|NCT00502697|B2|Baseline|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
608031|NCT00502697|B1|Baseline|Treatment Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
608032|NCT00502697|P2|Participant Flow|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care : Women in this group received conventional prenatal care and postpartum clinic care."
608033|NCT00502697|P1|Participant Flow|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
608034|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
608035|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
608036|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
608037|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
608038|NCT00502697|E2|Reported Event|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
608039|NCT00502697|E1|Reported Event|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
608040|NCT00502671|B1|Baseline|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
608041|NCT00502671|P1|Participant Flow|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
608042|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
608043|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
608672|NCT00501969|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
608681|NCT00501943|P1|Participant Flow|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
608044|NCT00502671|E1|Reported Event|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
608045|NCT00502593|B13|Baseline|Total|Total of all reporting groups
608046|NCT00502593|B12|Baseline|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608047|NCT00502593|B11|Baseline|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608048|NCT00502593|B10|Baseline|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608049|NCT00502593|B9|Baseline|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608050|NCT00502593|B8|Baseline|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608051|NCT00502593|B7|Baseline|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608052|NCT00502593|B6|Baseline|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608053|NCT00502593|B5|Baseline|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608054|NCT00502593|B4|Baseline|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608055|NCT00502593|B3|Baseline|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608056|NCT00502593|B2|Baseline|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608057|NCT00502593|B1|Baseline|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608058|NCT00502593|P12|Participant Flow|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608059|NCT00502593|P11|Participant Flow|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608060|NCT00502593|P10|Participant Flow|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608061|NCT00502593|P9|Participant Flow|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608062|NCT00502593|P8|Participant Flow|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608063|NCT00502593|P7|Participant Flow|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608064|NCT00502593|P6|Participant Flow|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608673|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
608674|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
608065|NCT00502593|P5|Participant Flow|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608066|NCT00502593|P4|Participant Flow|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608067|NCT00502593|P3|Participant Flow|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608068|NCT00502593|P2|Participant Flow|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608069|NCT00502593|P1|Participant Flow|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608070|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608071|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608072|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608073|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608074|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608075|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608076|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608077|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608078|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608079|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608080|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608081|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608082|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608083|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608084|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608085|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608086|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608087|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608088|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608089|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608090|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608091|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608092|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608093|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608094|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608095|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608096|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608097|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608098|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608099|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608100|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608101|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608102|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608103|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608104|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608105|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608106|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608107|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608108|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608109|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608110|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608111|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608112|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608113|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608114|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608115|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group Subjects Aged 6-9 Years Receive|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608116|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608117|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608118|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608119|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608120|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608121|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608122|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608123|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608124|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608125|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608126|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608127|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608128|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608129|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608130|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608131|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608132|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608133|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608134|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608135|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608136|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608137|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608138|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608139|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608140|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608141|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608142|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608143|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608144|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608145|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608146|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608147|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608148|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608149|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608150|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608151|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608152|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608153|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608154|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608155|NCT00502593|O3|Outcome|GSK1562902A–B Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608156|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608157|NCT00502593|O1|Outcome|GSK1562902A –B Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608158|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608159|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608160|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608161|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608162|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608163|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608164|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608165|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608166|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608167|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608168|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Fluarix–A 3-5Y Group
608169|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608170|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608171|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608172|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608173|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608174|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608675|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
608747|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
608175|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608176|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608177|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608178|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608179|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608180|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608181|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608182|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608183|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608184|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608185|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608186|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608187|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608188|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608189|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608190|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608191|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608192|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608193|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608194|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608195|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608196|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608197|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608198|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608199|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608200|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608201|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608202|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608203|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608204|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608205|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608206|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608207|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608208|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608209|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608210|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608211|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608212|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608213|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608214|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608215|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608216|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608217|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608218|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608219|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608220|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608221|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608222|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608223|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608224|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608225|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608226|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608227|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608228|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608229|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608230|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608231|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608232|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608233|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608234|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608235|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608236|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608237|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608238|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608239|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608240|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608241|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608242|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608243|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608244|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608245|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608246|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608247|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608248|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608249|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608250|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608251|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608252|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608253|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608254|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608255|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608256|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608257|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608258|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608259|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608260|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608261|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608262|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608263|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608264|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608265|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608266|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608267|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608268|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608269|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608270|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608271|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608272|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608273|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608274|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608275|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608276|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608277|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608278|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608279|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608280|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608281|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608282|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608283|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608284|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608285|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608286|NCT00502593|O6|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608287|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608288|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608289|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608290|NCT00502593|O2|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608291|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608292|NCT00502593|O6|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608293|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608294|NCT00502593|O4|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608295|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608296|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608297|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608298|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608299|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608300|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
608301|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
608302|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608303|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608304|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608305|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608306|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608307|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608308|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608309|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608310|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608311|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608312|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608313|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608314|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608315|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608316|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608317|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608318|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608319|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608320|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608321|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608322|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608323|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608324|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608325|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608326|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608327|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608328|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608329|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608330|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608331|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608332|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608333|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608334|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608335|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608336|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608337|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608338|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608339|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608340|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608341|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608342|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608343|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608344|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608345|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608346|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608347|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608348|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608349|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608350|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608351|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608352|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608353|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608354|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608355|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608356|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608357|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608358|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608359|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608360|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608361|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608362|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608363|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608364|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608365|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608366|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608367|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608368|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608369|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608370|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608371|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608372|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608373|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608374|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608375|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608376|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608377|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608378|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608379|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608380|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608381|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608382|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608383|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608384|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608385|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608386|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608387|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608388|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608389|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608390|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608391|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608392|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608393|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608394|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608395|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608396|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608397|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608398|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608399|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608400|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608401|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608402|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608403|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608404|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608405|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608406|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608407|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608408|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608409|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608410|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608411|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608412|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608413|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608414|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608415|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608416|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608417|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608418|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608419|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608420|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608421|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608422|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608423|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608424|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608425|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608426|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608427|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608428|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608429|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608430|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608431|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608432|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608433|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608434|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608435|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608436|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608437|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608438|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608439|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608440|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608441|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608442|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608443|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608444|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608445|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608446|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608447|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608448|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608449|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608450|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608451|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608452|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608453|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608454|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608455|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608456|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608457|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608458|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608459|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608460|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608461|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608462|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608463|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608464|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608465|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608466|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608467|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608468|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608469|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608470|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608471|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608472|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608473|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608474|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608475|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608476|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608477|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608478|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608479|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608480|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608481|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608482|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608483|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608484|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608485|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608486|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608487|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608488|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608489|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608490|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608491|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608492|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608493|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608494|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608495|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608496|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608497|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608498|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608499|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608500|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608501|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608502|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608503|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608504|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608505|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608506|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608507|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608508|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608509|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608510|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608511|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608512|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608513|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608514|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608515|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608516|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608517|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608518|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608519|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608520|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608521|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608522|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608523|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608524|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608525|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608526|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608527|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608528|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608529|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608530|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608531|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608532|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608533|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608534|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608535|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608536|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608537|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608538|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608539|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608540|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608541|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608542|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608543|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608544|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608545|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608546|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608547|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608548|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608549|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608550|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608551|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608552|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608553|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608554|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608555|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608556|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608557|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608558|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608559|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608560|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608561|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608562|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608563|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608564|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608565|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608566|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608567|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608568|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608569|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608570|NCT00502593|E12|Reported Event|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608571|NCT00502593|E11|Reported Event|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608572|NCT00502593|E10|Reported Event|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608573|NCT00502593|E9|Reported Event|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608574|NCT00502593|E8|Reported Event|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608575|NCT00502593|E7|Reported Event|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608576|NCT00502593|E6|Reported Event|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608577|NCT00502593|E5|Reported Event|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608578|NCT00502593|E4|Reported Event|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608579|NCT00502593|E3|Reported Event|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608580|NCT00502593|E2|Reported Event|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608581|NCT00502593|E1|Reported Event|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
608582|NCT00502320|B3|Baseline|Total|Total of all reporting groups
608583|NCT00502320|B2|Baseline|Placebo|inactive sugar pill taken by mouth nightly
608584|NCT00502320|B1|Baseline|Ramelteon|8 mg pill taken by mouth nightly
608585|NCT00502320|P2|Participant Flow|Placebo|inactive sugar pill taken by mouth nightly
608586|NCT00502320|P1|Participant Flow|Ramelteon|8 mg pill taken by mouth nightly
608587|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
608588|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
608589|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
608590|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
608591|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
608592|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
608593|NCT00502320|E2|Reported Event|Placebo|inactive sugar pill taken by mouth nightly
608594|NCT00502320|E1|Reported Event|Ramelteon|8 mg pill taken by mouth nightly
608595|NCT00502242|B3|Baseline|Total|Total of all reporting groups
608596|NCT00502242|B2|Baseline|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608597|NCT00502242|B1|Baseline|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608598|NCT00502242|P2|Participant Flow|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608599|NCT00502242|P1|Participant Flow|Ramipril|Participants were receiving cyclosporine (CsA) or tacrolimus (TAC) and either mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) or steroids dosed per center’s standard of care. Participants received ramipril, 5 or 10 milligrams per day (mg/d) orally (PO). 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of sirolimus [SRL] initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 nanograms per milliliter [ng/mL] less than [<]1 year post-transplant [PT], 5-15 ng/mL greater than or equal to [≥]1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if urinary protein to creatinine ratio (U p/c) was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608600|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608601|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608602|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608603|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608604|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608605|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608606|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608607|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608676|NCT00501969|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
608677|NCT00501943|B3|Baseline|Total|Total of all reporting groups
608748|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
608608|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608609|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608610|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608611|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608612|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608613|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608614|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608615|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608616|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608667|NCT00501995|P1|Participant Flow|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
608678|NCT00501943|B2|Baseline|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
608617|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608618|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608619|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608620|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608621|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608622|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608623|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608624|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608625|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608668|NCT00501995|O1|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
608679|NCT00501943|B1|Baseline|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
608626|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608627|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608628|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608629|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608630|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608631|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608632|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608633|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608634|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608669|NCT00501995|O1|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
608680|NCT00501943|P2|Participant Flow|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
608635|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608636|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608637|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608638|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608639|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608640|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608641|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608642|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608643|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608670|NCT00501995|E1|Reported Event|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
608671|NCT00501969|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
608644|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608645|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608646|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608647|NCT00502242|E2|Reported Event|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608648|NCT00502242|E1|Reported Event|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
608649|NCT00502216|B3|Baseline|Total|Total of all reporting groups
608650|NCT00502216|B2|Baseline|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
608651|NCT00502216|B1|Baseline|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
608652|NCT00502216|P2|Participant Flow|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
608653|NCT00502216|P1|Participant Flow|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
608654|NCT00502216|O2|Outcome|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
608655|NCT00502216|O1|Outcome|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
608656|NCT00502216|O2|Outcome|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
608657|NCT00502216|O1|Outcome|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
608658|NCT00502216|O2|Outcome|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
608659|NCT00502216|O1|Outcome|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
608660|NCT00502216|E2|Reported Event|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
608661|NCT00502216|E1|Reported Event|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
608662|NCT00502203|B1|Baseline|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
608663|NCT00502203|P1|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
608664|NCT00502203|O1|Outcome|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
608665|NCT00502203|E1|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
608666|NCT00501995|B1|Baseline|IV Cyclophosphamide (50 mg/kg)|This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)
608749|NCT00501592|E3|Reported Event|Placebo|Once daily by mouth
608682|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608683|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608684|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608685|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608686|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608687|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608688|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608689|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608690|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608691|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
608692|NCT00501943|O2|Outcome|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
608693|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
608694|NCT00501943|E2|Reported Event|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
608695|NCT00501943|E1|Reported Event|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
608696|NCT00501891|B1|Baseline|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
608697|NCT00501891|P1|Participant Flow|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
608698|NCT00501891|O1|Outcome|Bevacizumab and Metromonic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
608699|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
608700|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
608701|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
608702|NCT00501891|E1|Reported Event|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
608703|NCT00501852|B1|Baseline|Overall Study|
608704|NCT00501852|P1|Participant Flow|Overall Study|
608705|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608706|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608707|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608708|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608709|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608710|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608711|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608712|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608750|NCT00501592|E2|Reported Event|50 mg INT-747|Once daily by mouth
608751|NCT00501592|E1|Reported Event|25 mg INT-747|Once daily by mouth
615772|NCT00483119|B3|Baseline|Total|Total of all reporting groups
608713|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608714|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608715|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608716|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608717|NCT00501852|E6|Reported Event|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608718|NCT00501852|E5|Reported Event|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608719|NCT00501852|E4|Reported Event|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608720|NCT00501852|E3|Reported Event|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608721|NCT00501852|E2|Reported Event|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608722|NCT00501852|E1|Reported Event|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
608723|NCT00501644|B1|Baseline|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
608724|NCT00501644|P1|Participant Flow|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
608725|NCT00501644|O1|Outcome|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
608726|NCT00501644|E1|Reported Event|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
608727|NCT00501631|B3|Baseline|Total|Total of all reporting groups
608728|NCT00501631|B2|Baseline|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
608729|NCT00501631|B1|Baseline|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
608730|NCT00501631|P2|Participant Flow|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
608731|NCT00501631|P1|Participant Flow|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
608732|NCT00501631|O2|Outcome|Placebo|
608733|NCT00501631|O1|Outcome|Vivitrol|
608734|NCT00501631|E2|Reported Event|Placebo for VIVITROL 380 mg (Double-blind Period)|
608735|NCT00501631|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|
608736|NCT00501592|B4|Baseline|Total|Total of all reporting groups
608737|NCT00501592|B3|Baseline|Placebo|Once daily by mouth
608738|NCT00501592|B2|Baseline|50 mg INT-747|Once daily by mouth
608739|NCT00501592|B1|Baseline|25 mg INT-747|Once daily by mouth
608740|NCT00501592|P3|Participant Flow|Placebo|Once daily by mouth
608741|NCT00501592|P2|Participant Flow|50 mg INT-747|Once daily by mouth
608742|NCT00501592|P1|Participant Flow|25 mg INT-747|Once daily by mouth
608743|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
608744|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
608745|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
608746|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
608752|NCT00501540|B1|Baseline|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
608753|NCT00501540|P1|Participant Flow|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
608754|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
608755|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
608756|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
608757|NCT00501540|E1|Reported Event|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
608758|NCT00501345|B1|Baseline|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
608759|NCT00501345|P1|Participant Flow|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
608760|NCT00501345|O1|Outcome|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
608761|NCT00501345|E1|Reported Event|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
608762|NCT00501293|B3|Baseline|Total|Total of all reporting groups
608763|NCT00501293|B2|Baseline|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608764|NCT00501293|B1|Baseline|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608765|NCT00501293|P2|Participant Flow|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608766|NCT00501293|P1|Participant Flow|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608767|NCT00501293|O1|Outcome|Antecedent MTS and Antecedent Placebo|Methylphenidate Transdermal System and Placebo Patch
608768|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608769|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608770|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608771|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608772|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608773|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608774|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608775|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608776|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608777|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608778|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608779|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608780|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608781|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608782|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608783|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608784|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608785|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608786|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608787|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608788|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608789|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608790|NCT00501293|E2|Reported Event|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608791|NCT00501293|E1|Reported Event|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
608792|NCT00501228|B1|Baseline|Filgrastim Injections|
608793|NCT00501228|P1|Participant Flow|Filgrastim Injections|
608794|NCT00501228|O1|Outcome|Filgrastim Injections|
608795|NCT00501228|E1|Reported Event|Filgrastim Injections|
608796|NCT00501085|B1|Baseline|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608797|NCT00501085|P1|Participant Flow|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608798|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608799|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608800|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608801|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608802|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608803|NCT00501085|E1|Reported Event|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
608804|NCT00501059|B3|Baseline|Total|Total of all reporting groups
608805|NCT00501059|B2|Baseline|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608806|NCT00501059|B1|Baseline|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608807|NCT00501059|P2|Participant Flow|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608808|NCT00501059|P1|Participant Flow|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608809|NCT00501059|O2|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608810|NCT00501059|O1|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608811|NCT00501059|O2|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608812|NCT00501059|O1|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608813|NCT00501059|O2|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608814|NCT00501059|O1|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608815|NCT00501059|O2|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608816|NCT00501059|O1|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608817|NCT00501059|O2|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608868|NCT00500682|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
608818|NCT00501059|O1|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608819|NCT00501059|O2|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608820|NCT00501059|O1|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608821|NCT00501059|O2|Outcome|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608822|NCT00501059|O1|Outcome|Acetylsalicylic Acid (Aspirin, BAYE4465)|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
608823|NCT00501059|E2|Reported Event|Acetylsalicylic Acid|Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally one daily.
608824|NCT00501059|E1|Reported Event|Placebo|Subjects received 1 tablets of matching placebo orally once daily.
608825|NCT00501046|B3|Baseline|Total|Total of all reporting groups
608826|NCT00501046|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
608827|NCT00501046|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
608828|NCT00501046|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
608829|NCT00501046|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
608830|NCT00501046|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
608831|NCT00501046|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
608832|NCT00501046|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
608833|NCT00501046|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
608834|NCT00501007|B1|Baseline|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
608835|NCT00501007|P2|Participant Flow|Smokers With Schizophrenia / Schizoaffective Disorder|Smokers meeting criteria for schizophrenia or schizoaffective disorder
608836|NCT00501007|P1|Participant Flow|Non-psychiatric Smokers|Smokers without a diagnosis of schizophrenia or schizoaffective disorder
608837|NCT00501007|O1|Outcome|Smoking Cessation|Participants received tobacco dependence treatment
608838|NCT00501007|O2|Outcome|Non-psychiatric Group|Smokers NOT meeting criteria for schizophrenia, schizophrenia, bipolar disorder.
608839|NCT00501007|O1|Outcome|Schizophrenia or Schizoaffective Disorder|Smokers meeting Diagnostic and Statistical Manual criteria for Schizophrenia or Schizoaffective Disorder
608840|NCT00501007|E1|Reported Event|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
608841|NCT00500760|B3|Baseline|Total|Total of all reporting groups
608842|NCT00500760|B2|Baseline|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608843|NCT00500760|B1|Baseline|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608844|NCT00500760|P2|Participant Flow|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608845|NCT00500760|P1|Participant Flow|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608846|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608847|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608848|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608849|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608850|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608851|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608852|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608853|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608854|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608855|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608856|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608857|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608858|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
608859|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608860|NCT00500760|E2|Reported Event|Chemotherapy Plus Radiotherapy|
608861|NCT00500760|E1|Reported Event|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
608862|NCT00500682|B3|Baseline|Total|Total of all reporting groups
608863|NCT00500682|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
608864|NCT00500682|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
608865|NCT00500682|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
608866|NCT00500682|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
608867|NCT00500682|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
608870|NCT00500682|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
608871|NCT00500656|B5|Baseline|Total|Total of all reporting groups
608872|NCT00500656|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
608873|NCT00500656|B3|Baseline|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
608874|NCT00500656|B2|Baseline|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
608875|NCT00500656|B1|Baseline|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
608876|NCT00500656|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
608877|NCT00500656|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
608878|NCT00500656|P2|Participant Flow|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
608879|NCT00500656|P1|Participant Flow|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
608880|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
608881|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
608882|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
608883|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
608884|NCT00500656|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
608885|NCT00500656|E5|Reported Event|Open Label Extension Phase (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase and Open label extension phase.
608886|NCT00500656|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant+ oral placebo or Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
608887|NCT00500656|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
608888|NCT00500656|E2|Reported Event|Controlled Phase- Tranexamic Acid (Randomized Subjects)|Patients who were randomized to Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
608889|NCT00500656|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant+ oral placebo in the controlled phase and experienced adverse events while participating in the controlled phase
608890|NCT00500578|B3|Baseline|Total|Total of all reporting groups
608891|NCT00500578|B2|Baseline|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
608892|NCT00500578|B1|Baseline|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
608893|NCT00500578|P2|Participant Flow|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
608894|NCT00500578|P1|Participant Flow|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
608895|NCT00500578|O2|Outcome|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
608896|NCT00500578|O1|Outcome|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
608897|NCT00500578|E2|Reported Event|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
608898|NCT00500578|E1|Reported Event|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
608899|NCT00500539|B1|Baseline|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
608900|NCT00500539|P1|Participant Flow|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
608901|NCT00500539|O1|Outcome|Follow-up Period|Participants were assessed at 16 weeks after the last dose of study drug
608902|NCT00500539|O1|Outcome|Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
608903|NCT00500539|O1|Outcome|Follow-up Period|Participants were evaluated at 16 weeks after the last dose of study drug.
608904|NCT00500539|E2|Reported Event|Omalizumab Follow up Period|Participants were assessed at 16 weeks after the last dose of study drug
608905|NCT00500539|E1|Reported Event|Omalizumab Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
608906|NCT00500448|B3|Baseline|Total|Total of all reporting groups
608907|NCT00500448|B2|Baseline|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608908|NCT00500448|B1|Baseline|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608909|NCT00500448|P2|Participant Flow|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608910|NCT00500448|P1|Participant Flow|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608911|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608912|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608913|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608914|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608915|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608916|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608917|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608918|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608919|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608920|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608921|NCT00500448|E2|Reported Event|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
608922|NCT00500448|E1|Reported Event|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
608923|NCT00500370|B3|Baseline|Total|Total of all reporting groups
608924|NCT00500370|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608925|NCT00500370|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608926|NCT00500370|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608927|NCT00500370|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608928|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608929|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608930|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608931|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608932|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608933|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608934|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608935|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608936|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608937|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608938|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608939|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608940|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608941|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608942|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608943|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608944|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608945|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608946|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608947|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608948|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608949|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608950|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608951|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608952|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608953|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608954|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608955|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608956|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608957|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608958|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608959|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608960|NCT00500370|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
608961|NCT00500370|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
608962|NCT00500357|B1|Baseline|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608963|NCT00500357|P1|Participant Flow|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 [Vax 1]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608964|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608965|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
608966|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608967|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
608968|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608969|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
608970|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608971|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608972|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
608973|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
608974|NCT00500357|E7|Reported Event|13vPnC-AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
608975|NCT00500357|E6|Reported Event|13vPnC+AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
608976|NCT00500357|E5|Reported Event|13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)|Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
608977|NCT00500357|E4|Reported Event|23vPS (After Vax 1 Core Study)|Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
608978|NCT00500357|E3|Reported Event|13vPnC-AlPO4 (After Vax 1 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
608979|NCT00500357|E2|Reported Event|13vPnC+AlPO4 (After Vax 1 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
608980|NCT00500357|E1|Reported Event|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)|"Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).~For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46."
608981|NCT00500331|B8|Baseline|Total|Total of all reporting groups
608982|NCT00500331|B7|Baseline|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
608983|NCT00500331|B6|Baseline|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608984|NCT00500331|B5|Baseline|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608985|NCT00500331|B4|Baseline|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608986|NCT00500331|B3|Baseline|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608987|NCT00500331|B2|Baseline|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608988|NCT00500331|B1|Baseline|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
608989|NCT00500331|P7|Participant Flow|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
608990|NCT00500331|P6|Participant Flow|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608991|NCT00500331|P5|Participant Flow|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608992|NCT00500331|P4|Participant Flow|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608993|NCT00500331|P3|Participant Flow|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608994|NCT00500331|P2|Participant Flow|GSK189075 50 mg|Eligible participants received GSK189075 50 milligram (mg) tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608995|NCT00500331|P1|Participant Flow|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
608996|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
608997|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608998|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
608999|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609000|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609001|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609002|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609003|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609004|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609005|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609006|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609007|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609008|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609009|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609010|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609011|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609012|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609013|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609014|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609015|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609016|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609017|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609018|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609019|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609020|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609021|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609022|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609023|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609024|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609025|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609026|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609027|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609028|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609029|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609030|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609031|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609032|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609033|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609034|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609035|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609036|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609037|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609038|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609039|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609040|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609041|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609042|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609043|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609044|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609045|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609046|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609047|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609048|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609049|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609050|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609051|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609052|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609053|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609054|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609055|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609056|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609057|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609058|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609059|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609060|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609061|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609062|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609063|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609064|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609065|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609066|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609067|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609068|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609069|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609070|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609071|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609072|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609073|NCT00500331|O7|Outcome|Pioglitazone 30mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609074|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609075|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609076|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609077|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609078|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609079|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609080|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609081|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609082|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609083|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609084|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609085|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609086|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609087|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609088|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609089|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609090|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609091|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609092|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609093|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609094|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609095|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609096|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609097|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609098|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609099|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609100|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609101|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609102|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609103|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609104|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609105|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609106|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609107|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609108|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609109|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609110|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609111|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609112|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609113|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609114|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609115|NCT00500331|O7|Outcome|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609116|NCT00500331|O6|Outcome|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609117|NCT00500331|O5|Outcome|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609118|NCT00500331|O4|Outcome|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609119|NCT00500331|O3|Outcome|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609120|NCT00500331|O2|Outcome|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609121|NCT00500331|O1|Outcome|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609122|NCT00500331|E7|Reported Event|Pioglitazone 30 mg|Eligible participants received Pioglitazone 30 mg tablets, orally, once daily before breakfast for 12 weeks.
609123|NCT00500331|E6|Reported Event|GSK189075 1000 mg|Eligible participants received GSK189075 1000 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609124|NCT00500331|E5|Reported Event|GSK189075 500 mg|Eligible participants received GSK189075 500 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609125|NCT00500331|E4|Reported Event|GSK189075 250 mg|Eligible participants received GSK189075 250 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609126|NCT00500331|E3|Reported Event|GSK189075 100 mg|Eligible participants received GSK189075 100 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609127|NCT00500331|E2|Reported Event|GSK189075 50 mg|Eligible participants received GSK189075 50 mg tablets, orally, twice daily before breakfast and dinner for 12 weeks.
609128|NCT00500331|E1|Reported Event|Placebo|Eligible participants received matching placebo, orally, twice daily before breakfast and dinner for 12 weeks.
609129|NCT00500318|B3|Baseline|Total|Total of all reporting groups
609130|NCT00500318|B2|Baseline|Placebo|Dose-matched placebo, oral inhalation, once per day.
609131|NCT00500318|B1|Baseline|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609132|NCT00500318|P2|Participant Flow|Placebo|Dose-matched placebo, oral inhalation, once per day.
609133|NCT00500318|P1|Participant Flow|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609134|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
609135|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609136|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
609137|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609138|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
609139|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609140|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
609141|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609142|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
609143|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609144|NCT00500318|E2|Reported Event|Placebo|Dose-matched placebo, oral inhalation, once per day.
609145|NCT00500318|E1|Reported Event|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
609146|NCT00500292|B4|Baseline|Total|Total of all reporting groups
609147|NCT00500292|B3|Baseline|Placebo Plus FOLFOX|placebo plus FOLFOX
609148|NCT00500292|B2|Baseline|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
617082|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
609149|NCT00500292|B1|Baseline|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
609150|NCT00500292|P3|Participant Flow|Placebo Plus FOLFOX|placebo plus FOLFOX
609151|NCT00500292|P2|Participant Flow|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
609152|NCT00500292|P1|Participant Flow|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
609153|NCT00500292|O3|Outcome|Placebo Plus FOLFOX|placebo plus FOLFOX
609154|NCT00500292|O2|Outcome|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
609155|NCT00500292|O1|Outcome|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
609156|NCT00500292|E3|Reported Event|Placebo|placebo plus FOLFOX
609157|NCT00500292|E2|Reported Event|Vandetanib 300 mg|vandetanib 300 mg plus FOLFOX
609158|NCT00500292|E1|Reported Event|Vandetanib 100 mg|vandetanib 100 mg plus FOLFOX
609159|NCT00500240|B3|Baseline|Total|Total of all reporting groups
609160|NCT00500240|B2|Baseline|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
609161|NCT00500240|B1|Baseline|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
609162|NCT00500240|P2|Participant Flow|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
609163|NCT00500240|P1|Participant Flow|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
609164|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
609165|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
609166|NCT00500240|O2|Outcome|Intervention Group|Intense blood sugar management with Insulin Aspart + Insulin Glargine
609167|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin
609168|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
609169|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
609170|NCT00500240|E2|Reported Event|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
609171|NCT00500240|E1|Reported Event|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
609172|NCT00500149|B1|Baseline|Entire Study Population|
609173|NCT00500149|P2|Participant Flow|Placebo First|Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention
609174|NCT00500149|P1|Participant Flow|Vyvanse First|Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
609175|NCT00500149|O2|Outcome|Placebo|Matching placebo
609176|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609177|NCT00500149|O2|Outcome|Placebo|Matching placebo
609178|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609179|NCT00500149|E2|Reported Event|Placebo|
609180|NCT00500149|E1|Reported Event|Vyvanse|
609181|NCT00500110|B1|Baseline|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
609182|NCT00500110|P1|Participant Flow|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
609183|NCT00500110|O1|Outcome|Treatment|
609184|NCT00500110|E1|Reported Event|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
609185|NCT00500071|B1|Baseline|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609186|NCT00500071|P1|Participant Flow|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609187|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609188|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609189|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609190|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609191|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609192|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609193|NCT00500071|E1|Reported Event|Vyvanse|Lisdexamfetamine dimesylate (LDX)
609194|NCT00499915|B3|Baseline|Total|Total of all reporting groups
609195|NCT00499915|B2|Baseline|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
609196|NCT00499915|B1|Baseline|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
609197|NCT00499915|P2|Participant Flow|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
609198|NCT00499915|P1|Participant Flow|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
609199|NCT00499915|O2|Outcome|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
609200|NCT00499915|O1|Outcome|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
609201|NCT00499915|E2|Reported Event|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
609202|NCT00499915|E1|Reported Event|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
609203|NCT00499889|B1|Baseline|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
609204|NCT00499889|P1|Participant Flow|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
609205|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
609206|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
609207|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
609208|NCT00499889|E1|Reported Event|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
609209|NCT00499863|B3|Baseline|Total|Total of all reporting groups
609210|NCT00499863|B2|Baseline|Placebo (PTS)|Placebo Transdermal System
609211|NCT00499863|B1|Baseline|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609212|NCT00499863|P2|Participant Flow|Placebo (PTS)|Placebo Transdermal System
609213|NCT00499863|P1|Participant Flow|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609214|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609215|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609216|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609217|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609218|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609219|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609220|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609221|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609222|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609223|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609224|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609225|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609226|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609227|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609228|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609229|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609230|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609231|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609232|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609233|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609234|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609235|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609236|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
609237|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609238|NCT00499863|E2|Reported Event|Placebo (PTS)|Placebo Transdermal System
609239|NCT00499863|E1|Reported Event|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
609240|NCT00500266|B1|Baseline|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
609241|NCT00500266|P1|Participant Flow|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
609242|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
609243|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
609244|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
609245|NCT00500266|E2|Reported Event|13vPnC: 6-month Follow-up|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
609246|NCT00500266|E1|Reported Event|13vPnC: Visit 1 to Visit 2|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.
609247|NCT00499746|B1|Baseline|Group 1|
609248|NCT00499746|P1|Participant Flow|All Participants|Participant flow is reported in single group due to the number of randomized sequences. In Phase 1 and Phase 2, each participant received two exposures of each training drug in randomize order (placebo, Hydromorphone 8 mg, Methylphenidate 60 mg). In Phase 3, each participant received randomized exposure to placebo, Hydromorphone (4 and 8 mg), Methylphenidate (30 and 60 mg), tramadol (50, 100, 200, and 400 mg).
609249|NCT00499746|O9|Outcome|Tramadol 400 mg|
609250|NCT00499746|O8|Outcome|Tramadol 200 mg|
609251|NCT00499746|O7|Outcome|Tramadol 100 mg|
609252|NCT00499746|O6|Outcome|Tramadol 50 mg|
609253|NCT00499746|O5|Outcome|Methylphenidate 60 mg|
609254|NCT00499746|O4|Outcome|Methylphenidate 30 mg|
609255|NCT00499746|O3|Outcome|Hydromorphone 8 mg|
609256|NCT00499746|O2|Outcome|Hydromorphone 4 mg|
609257|NCT00499746|O1|Outcome|Placebo 0 mg|
609258|NCT00499746|O9|Outcome|Tramadol 400 mg|
609259|NCT00499746|O8|Outcome|Tramadol 200 mg|
609260|NCT00499746|O7|Outcome|Tramadol 100 mg|
609261|NCT00499746|O6|Outcome|Tramadol 50 mg|
609262|NCT00499746|O5|Outcome|Methylphenidate 60 mg|
609263|NCT00499746|O4|Outcome|Methylphenidate 30 mg|
609264|NCT00499746|O3|Outcome|Hydromorphone 8 mg|
609265|NCT00499746|O2|Outcome|Hydromorphone 4 mg|
609266|NCT00499746|O1|Outcome|Placebo 0 mg|
609267|NCT00499746|O9|Outcome|Tramadol 400 mg|
609268|NCT00499746|O8|Outcome|Tramadol 200 mg|
609269|NCT00499746|O7|Outcome|Tramadol 100 mg|
609270|NCT00499746|O6|Outcome|Tramadol 50 mg|
609271|NCT00499746|O5|Outcome|Methylphenidate 60 mg|
609272|NCT00499746|O4|Outcome|Methylphenidate 30 mg|
609273|NCT00499746|O3|Outcome|Hydromorphone 8 mg|
609274|NCT00499746|O2|Outcome|Hydromorphone 4 mg|
609275|NCT00499746|O1|Outcome|Placebo 0 mg|
609276|NCT00499746|O9|Outcome|Tramadol 400 mg|
609277|NCT00499746|O8|Outcome|Tramadol 200 mg|
609278|NCT00499746|O7|Outcome|Tramadol 100 mg|
609279|NCT00499746|O6|Outcome|Tramadol 50 mg|
609280|NCT00499746|O5|Outcome|Methylphenidate 60 mg|
609281|NCT00499746|O4|Outcome|Methylphenidate 30 mg|
609282|NCT00499746|O3|Outcome|Hydromorphone 8 mg|
609283|NCT00499746|O2|Outcome|Hydromorphone 4 mg|
609284|NCT00499746|O1|Outcome|Placebo 0 mg|
609285|NCT00499746|O9|Outcome|Tramadol 400 mg|
609286|NCT00499746|O8|Outcome|Tramadol 200 mg|
609287|NCT00499746|O7|Outcome|Tramadol 100 mg|
609288|NCT00499746|O6|Outcome|Tramadol 50 mg|
609289|NCT00499746|O5|Outcome|Methylphenidate 60 mg|
609290|NCT00499746|O4|Outcome|Methylphenidate 30 mg|
609291|NCT00499746|O3|Outcome|Hydromorphone 8 mg|
609292|NCT00499746|O2|Outcome|Hydromorphone 4 mg|
609293|NCT00499746|O1|Outcome|Placebo 0 mg|
609294|NCT00499746|O9|Outcome|Tramadol 400 mg|
609295|NCT00499746|O8|Outcome|Tramadol 200 mg|
609296|NCT00499746|O7|Outcome|Tramadol 100 mg|
609297|NCT00499746|O6|Outcome|Tramadol 50 mg|
609298|NCT00499746|O5|Outcome|Methylphenidate 60 mg|
609299|NCT00499746|O4|Outcome|Methylphenidate 30 mg|
609300|NCT00499746|O3|Outcome|Hydromorphone 8 mg|
609301|NCT00499746|O2|Outcome|Hydromorphone 4 mg|
609302|NCT00499746|O1|Outcome|Placebo 0 mg|
609303|NCT00499746|O9|Outcome|Tramadol 400 mg|
609304|NCT00499746|O8|Outcome|Tramadol 200 mg|
609305|NCT00499746|O7|Outcome|Tramadol 100 mg|
609306|NCT00499746|O6|Outcome|Tramadol 50 mg|
609307|NCT00499746|O5|Outcome|Methylphenidate 60 mg|
609308|NCT00499746|O4|Outcome|Methylphenidate 30 mg|
609309|NCT00499746|O3|Outcome|Hydromorphone 8 mg|
609310|NCT00499746|O2|Outcome|Hydromorphone 4 mg|
609311|NCT00499746|O1|Outcome|Placebo 0 mg|
609312|NCT00499746|O3|Outcome|Methylphenidate 60 mg|
609313|NCT00499746|O2|Outcome|Hydromorphone 8 mg|
609314|NCT00499746|O1|Outcome|Placebo 0 mg|
609316|NCT00499694|B1|Baseline|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
609317|NCT00499694|P1|Participant Flow|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
609318|NCT00499694|O1|Outcome|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
609319|NCT00499694|O1|Outcome|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
609320|NCT00499694|O1|Outcome|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
609321|NCT00499694|O1|Outcome|Bevacizumab and Satraplatin|"Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
609322|NCT00499694|E1|Reported Event|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
609323|NCT00499681|B3|Baseline|Total|Total of all reporting groups
609324|NCT00499681|B2|Baseline|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
609325|NCT00499681|B1|Baseline|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
609326|NCT00499681|P2|Participant Flow|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
609327|NCT00499681|P1|Participant Flow|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
609328|NCT00499681|O2|Outcome|Part 1: Letrozole Plus Placebo Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with a placebo and 14 weeks treatment with letrozole and lapatinib
609329|NCT00499681|O1|Outcome|Part I and Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with lapatinib and 14 weeks treatment with letrozole and lapatinib
609330|NCT00499681|E2|Reported Event|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
609331|NCT00499681|E1|Reported Event|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
609332|NCT00499655|B3|Baseline|Total|Total of all reporting groups
609333|NCT00499655|B2|Baseline|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609334|NCT00499655|B1|Baseline|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609335|NCT00499655|P2|Participant Flow|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609465|NCT00499447|P1|Participant Flow|Radiofrequency Ablation Combined With External|
609336|NCT00499655|P1|Participant Flow|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609337|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg oforal erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609338|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609339|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609340|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609341|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609342|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609343|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609344|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609345|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609346|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609347|NCT00499655|E2|Reported Event|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609348|NCT00499655|E1|Reported Event|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
609349|NCT00499616|B5|Baseline|Total|Total of all reporting groups
609350|NCT00499616|B4|Baseline|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.~Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
609434|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609351|NCT00499616|B3|Baseline|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S disease who achieve a very good PR (VGPR) to chemo (with the exception of resolution of skin or liver metastases in stage 4S patients) proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609352|NCT00499616|B2|Baseline|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609353|NCT00499616|B1|Baseline|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609354|NCT00499616|P4|Participant Flow|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.~Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
609355|NCT00499616|P3|Participant Flow|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609356|NCT00499616|P2|Participant Flow|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609357|NCT00499616|P1|Participant Flow|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609358|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609359|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609360|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609361|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609362|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609363|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609461|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oxycodone oral clearance following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
609364|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609365|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609366|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609367|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609368|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609369|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609370|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609371|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609372|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609373|NCT00499616|O1|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609374|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609375|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609376|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609462|NCT00499460|E2|Reported Event|Placebo|Data for all subjects during their placebo treatment period in both arms were pooled.
609466|NCT00499447|O1|Outcome|Radiofrequency Ablation Combined With External|
609377|NCT00499616|O2|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609378|NCT00499616|O1|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609379|NCT00499616|O2|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609380|NCT00499616|O1|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609381|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609382|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609383|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609384|NCT00499616|O3|Outcome|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609385|NCT00499616|O2|Outcome|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609386|NCT00499616|O1|Outcome|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609387|NCT00499616|E4|Reported Event|Non-intermediate Risk Enrolled on Intermediate Risk Trial|"The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531.~Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished."
609388|NCT00499616|E3|Reported Event|Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)|8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients < 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609389|NCT00499616|E2|Reported Event|Group 3 (Chemotherapy, Surgery)|4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
609433|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609467|NCT00499447|E1|Reported Event|Radiofrequency Ablation Combined With External|
609390|NCT00499616|E1|Reported Event|Group 2 (Chemotherapy, Surgery)|2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
609391|NCT00499603|B3|Baseline|Total|Total of all reporting groups
609392|NCT00499603|B2|Baseline|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609393|NCT00499603|B1|Baseline|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609394|NCT00499603|P2|Participant Flow|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609395|NCT00499603|P1|Participant Flow|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609396|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609397|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609398|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609399|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609400|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609401|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609402|NCT00499603|E2|Reported Event|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609463|NCT00499460|E1|Reported Event|Garlic|Data for all subjects during their active garlic treatment period in both arms were pooled.
609403|NCT00499603|E1|Reported Event|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
609404|NCT00499590|B4|Baseline|Total|Total of all reporting groups
609405|NCT00499590|B3|Baseline|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609406|NCT00499590|B2|Baseline|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609407|NCT00499590|B1|Baseline|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
609408|NCT00499590|P3|Participant Flow|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609409|NCT00499590|P2|Participant Flow|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609410|NCT00499590|P1|Participant Flow|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
609411|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609412|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609413|NCT00499590|O1|Outcome|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
609414|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609415|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609416|NCT00499590|O1|Outcome|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
609417|NCT00499590|E3|Reported Event|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609418|NCT00499590|E2|Reported Event|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
609419|NCT00499590|E1|Reported Event|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
609420|NCT00499486|B1|Baseline|Sirolimus|adencarcinoma refractory to gemcitibine
609421|NCT00499486|P1|Participant Flow|Sirolimus|Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.
609422|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
609423|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
609424|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
609425|NCT00499486|E1|Reported Event|Sirolimus|Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
609426|NCT00499473|B3|Baseline|Total|Total of all reporting groups
609427|NCT00499473|B2|Baseline|Stratum 2: Patients on EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609428|NCT00499473|B1|Baseline|Stratum I: Patients Not on EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609429|NCT00499473|P2|Participant Flow|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609430|NCT00499473|P1|Participant Flow|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609431|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609432|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609435|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609436|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609437|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609438|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609439|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609440|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609441|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
609442|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609443|NCT00499473|E2|Reported Event|Stratum 2: EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib. In addition to EIAC (Enzyme-inducing anticonvulsant)
609444|NCT00499473|E1|Reported Event|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
609445|NCT00499460|B3|Baseline|Total|Total of all reporting groups
609446|NCT00499460|B2|Baseline|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
609447|NCT00499460|B1|Baseline|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
609448|NCT00499460|P2|Participant Flow|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
609449|NCT00499460|P1|Participant Flow|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
609450|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oral digoxin AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
609451|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oral digoxin AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
609452|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oral midazolam AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
609453|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oral midazolam AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
609454|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of CASE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
609455|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of CASE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
609456|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of SSE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
609457|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of SSE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
609458|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of Cold Pressor Test Tolerance AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
609459|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of Cold Pressor Test Tolerance AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
609460|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oxycodone oral clearance following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
609464|NCT00499447|B1|Baseline|Radiofrequency Ablation Combined With External|
609468|NCT00499408|B1|Baseline|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
609469|NCT00499408|P1|Participant Flow|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
609470|NCT00499408|O1|Outcome|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
609471|NCT00499408|E1|Reported Event|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
609472|NCT00499369|B6|Baseline|Total|Total of all reporting groups
609473|NCT00499369|B5|Baseline|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609474|NCT00499369|B4|Baseline|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609475|NCT00499369|B3|Baseline|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609476|NCT00499369|B2|Baseline|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609477|NCT00499369|B1|Baseline|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609478|NCT00499369|P5|Participant Flow|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609479|NCT00499369|P4|Participant Flow|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609480|NCT00499369|P3|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609481|NCT00499369|P2|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609482|NCT00499369|P1|Participant Flow|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609483|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609484|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609485|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609486|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609487|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609488|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609489|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609490|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609491|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609492|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609493|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609494|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609495|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609618|NCT00498628|B2|Baseline|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
609496|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609497|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609498|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609499|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609500|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609501|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609502|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609503|NCT00499369|E5|Reported Event|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609504|NCT00499369|E4|Reported Event|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609505|NCT00499369|E3|Reported Event|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609506|NCT00499369|E2|Reported Event|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609507|NCT00499369|E1|Reported Event|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
609508|NCT00499343|B3|Baseline|Total|Total of all reporting groups
609509|NCT00499343|B2|Baseline|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
609510|NCT00499343|B1|Baseline|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
609511|NCT00499343|P2|Participant Flow|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
609512|NCT00499343|P1|Participant Flow|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
609513|NCT00499343|O2|Outcome|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
609514|NCT00499343|O1|Outcome|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
609515|NCT00499343|E2|Reported Event|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
609516|NCT00499343|E1|Reported Event|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
609517|NCT00499252|B1|Baseline|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
609518|NCT00499252|P1|Participant Flow|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
609519|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
609520|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
609521|NCT00499252|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
609522|NCT00499252|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
609523|NCT00499252|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
609524|NCT00499252|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
609525|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
609526|NCT00499252|E1|Reported Event|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
609527|NCT00499122|B1|Baseline|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
609619|NCT00498628|B1|Baseline|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
609528|NCT00499122|P1|Participant Flow|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
609529|NCT00499122|O1|Outcome|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1~Cyclophosphamide~Docetaxel~Doxorubicin~NOV 002"
609530|NCT00499122|O1|Outcome|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1~Cyclophosphamide~Docetaxel~Doxorubicin~NOV 002"
609531|NCT00499122|O1|Outcome|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
609532|NCT00499122|E1|Reported Event|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
609533|NCT00499109|B3|Baseline|Total|Total of all reporting groups
609534|NCT00499109|B2|Baseline|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
609535|NCT00499109|B1|Baseline|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
609536|NCT00499109|P2|Participant Flow|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
609537|NCT00499109|P1|Participant Flow|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
609538|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
609539|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
609540|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
609541|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
609542|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
609543|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
609544|NCT00499109|E5|Reported Event|Control: C|Gemcitabine/Carboplatin
609545|NCT00499109|E4|Reported Event|Experimental: E4|Gemcitabine/Carboplatin
609546|NCT00499109|E3|Reported Event|Experimental: E3|Gemcitabine/Docetaxel
609547|NCT00499109|E2|Reported Event|Experimental: E2|Docetaxel/Carboplatin
609548|NCT00499109|E1|Reported Event|Experimental: E1|Docetaxel/Vinorelbine
609549|NCT00499096|B3|Baseline|Total|Total of all reporting groups
609550|NCT00499096|B2|Baseline|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease (CVD) will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609564|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609551|NCT00499096|B1|Baseline|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease (CVD); group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609552|NCT00499096|P2|Participant Flow|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609553|NCT00499096|P1|Participant Flow|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609554|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609555|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609556|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609557|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609558|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609559|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609560|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609561|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder~Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609562|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609563|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609565|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder~Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609566|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609567|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609568|NCT00499096|E2|Reported Event|Arm 2|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
609569|NCT00499096|E1|Reported Event|Arm 1|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
609570|NCT00499031|B1|Baseline|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
609571|NCT00499031|P1|Participant Flow|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
609572|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
609573|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
609574|NCT00499031|E1|Reported Event|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
609575|NCT00498940|B3|Baseline|Total|Total of all reporting groups
609576|NCT00498940|B2|Baseline|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
609577|NCT00498940|B1|Baseline|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
609578|NCT00498940|P2|Participant Flow|Standard of Care|"No post operative pacing is to occur. Patients will undergo optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass."
609579|NCT00498940|P1|Participant Flow|Biventricular Pacing|"After weaning from bypass, patients will receive temporary biventricular pacing for 24 hours. Values obtained from optimization testing will determine pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours."
609580|NCT00498940|O2|Outcome|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
609613|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
609614|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
609615|NCT00498706|E2|Reported Event|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
609616|NCT00498706|E1|Reported Event|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
609581|NCT00498940|O1|Outcome|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
609582|NCT00498940|O2|Outcome|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
609583|NCT00498940|O1|Outcome|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
609584|NCT00498940|E2|Reported Event|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
609585|NCT00498940|E1|Reported Event|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
609586|NCT00498927|B1|Baseline|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
609587|NCT00498927|P1|Participant Flow|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
609588|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
609589|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
609590|NCT00498927|E1|Reported Event|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
609591|NCT00498797|B3|Baseline|Total|Total of all reporting groups
609592|NCT00498797|B2|Baseline|Placebo|docetaxel/prednisolone/placebo
609593|NCT00498797|B1|Baseline|Vandetanib|docetaxel/prednisolone/vandetanib
609594|NCT00498797|P2|Participant Flow|Placebo|docetaxel/prednisolone/placebo
609595|NCT00498797|P1|Participant Flow|Vandetanib|docetaxel/prednisolone/vandetanib
609596|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
609597|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
609598|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
609599|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
609600|NCT00498797|E2|Reported Event|Placebo|docetaxel/prednisolone/placebo
609601|NCT00498797|E1|Reported Event|Vandetanib|docetaxel/prednisolone/vandetanib
609602|NCT00498706|B3|Baseline|Total|Total of all reporting groups
609603|NCT00498706|B2|Baseline|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
609604|NCT00498706|B1|Baseline|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
609605|NCT00498706|P2|Participant Flow|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
609606|NCT00498706|P1|Participant Flow|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
609607|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
609608|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
609609|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
609610|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
609611|NCT00498706|O2|Outcome|Face-to-face Cognitive Behavioral Therapy|Participants will receive face-to-face cognitive behavioral therapy.
609612|NCT00498706|O1|Outcome|Telephone-administered Cognitive Behavioral Therapy|Participants will receive telephone-administered cognitive behavioral therapy.
609620|NCT00498628|P2|Participant Flow|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
609621|NCT00498628|P1|Participant Flow|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
609622|NCT00498628|O2|Outcome|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
609623|NCT00498628|O1|Outcome|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
609624|NCT00498628|E2|Reported Event|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
609625|NCT00498628|E1|Reported Event|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
609626|NCT00498615|B1|Baseline|3 Period Crossover Study ( All Participants)|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge.~Men and women between ages 18–80 years with a clinical diagnosis of RP secondary to SSc were eligible for the study."
609627|NCT00498615|P6|Participant Flow|Sequence 6|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
609628|NCT00498615|P5|Participant Flow|Sequence 5|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
609629|NCT00498615|P4|Participant Flow|Sequence 4|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
609630|NCT00498615|P3|Participant Flow|Sequence 3|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
609631|NCT00498615|P2|Participant Flow|Sequence 2|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
609632|NCT00498615|P1|Participant Flow|Sequence 1|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods.
609633|NCT00498615|O3|Outcome|Placebo|"Time to reach 70% of skin temperature after cold challenge done 2 hrs after taking placebo~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
609634|NCT00498615|O2|Outcome|40 mg Fasudil|"Time to reach 70% skin temperature after cold challenge done 2 hrs after dosing.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
609635|NCT00498615|O1|Outcome|Fasudil 80 mg|"Time to recover 70% of baseline skin temperature after cold challenge done 2 hrs after dose.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
609636|NCT00498615|O3|Outcome|Placebo|In this group participants received placebo 2 hours before cold challenge.
609637|NCT00498615|O2|Outcome|40 mg Fasudil|In this group participants received 40mg of Fasudil 2 hours before cold challenge
609638|NCT00498615|O1|Outcome|80 mg Fasudil|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil In this arm participants received 80 mg of Fasudil 2 hours before a standardized cold challenge.~Men and women between ages 18–80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study."
609639|NCT00498615|O3|Outcome|Placebo|participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
609640|NCT00498615|O2|Outcome|80 mg Fasudil|participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
609641|NCT00498615|O1|Outcome|40 mg Fasudil|This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
609642|NCT00498615|E3|Reported Event|80mg Fasudil|80mg Fasudil was administered 2 hours before a standardized cold challenge.
609643|NCT00498615|E2|Reported Event|40 mg Fasudil|40 mg Fasudil was administered 2 hours before a standardized cold challenge.
609644|NCT00498615|E1|Reported Event|Placebo|Placebo was administered 2 hours before a standardized cold challenge.
609645|NCT00498602|B8|Baseline|Total|Total of all reporting groups
609646|NCT00498602|B7|Baseline|Phosphate Buffered Saline|Participants received PBS. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609647|NCT00498602|B6|Baseline|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609648|NCT00498602|B5|Baseline|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609649|NCT00498602|B4|Baseline|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609650|NCT00498602|B3|Baseline|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609651|NCT00498602|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609652|NCT00498602|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609653|NCT00498602|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609654|NCT00498602|P6|Participant Flow|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609655|NCT00498602|P5|Participant Flow|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609656|NCT00498602|P4|Participant Flow|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609657|NCT00498602|P3|Participant Flow|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609658|NCT00498602|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609659|NCT00498602|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609660|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609661|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609662|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609663|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609664|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609665|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609666|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609667|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609668|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609669|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609670|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609671|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609672|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609673|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609674|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609675|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609676|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609677|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
619464|NCT00473655|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg
609678|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609679|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609680|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609681|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609682|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609683|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609684|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609685|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609686|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609687|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609688|NCT00498602|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609689|NCT00498602|E6|Reported Event|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609690|NCT00498602|E5|Reported Event|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609691|NCT00498602|E4|Reported Event|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609692|NCT00498602|E3|Reported Event|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609693|NCT00498602|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609694|NCT00498602|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
609695|NCT00498550|B3|Baseline|Total|Total of all reporting groups
609696|NCT00498550|B2|Baseline|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
609697|NCT00498550|B1|Baseline|Clozapine|Clozapine, Clozaril
609698|NCT00498550|P2|Participant Flow|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
609699|NCT00498550|P1|Participant Flow|Clozapine|Clozapine, Clozaril
609700|NCT00498550|O2|Outcome|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
609701|NCT00498550|O1|Outcome|Clozapine|Clozapine, Clozaril
609702|NCT00498550|E2|Reported Event|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
609703|NCT00498550|E1|Reported Event|Clozapine|Clozapine, Clozaril
609704|NCT00498485|B3|Baseline|Total|Total of all reporting groups
609705|NCT00498485|B2|Baseline|Xyrem|Xyrem: Same as for Placebo
609706|NCT00498485|B1|Baseline|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
609707|NCT00498485|P2|Participant Flow|Xyrem|Xyrem: Same as for Placebo
609708|NCT00498485|P1|Participant Flow|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
609709|NCT00498485|O2|Outcome|Xyrem|Xyrem: Same as for Placebo
609732|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609733|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609734|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609710|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
609711|NCT00498485|O2|Outcome|Drug Treated|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
609712|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
609713|NCT00498485|E2|Reported Event|Xyrem|Xyrem: Same as for Placebo
609714|NCT00498485|E1|Reported Event|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
609715|NCT00498433|B4|Baseline|Total|Total of all reporting groups
609716|NCT00498433|B3|Baseline|Part 2, Double Blind: Amlodipine|Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609717|NCT00498433|B2|Baseline|Part 2, Double Blind Period: Aliskiren|Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609718|NCT00498433|B1|Baseline|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609719|NCT00498433|P3|Participant Flow|Amlodipine|"Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.~Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks"
609720|NCT00498433|P2|Participant Flow|Aliskiren|"Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks"
609721|NCT00498433|P1|Participant Flow|Placebo|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 2, Period 1: After confirming study eligibility based on inclusion and exclusion criteria, patients underwent a two week single-blind placebo run-in phase."
609722|NCT00498433|O3|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609723|NCT00498433|O2|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609724|NCT00498433|O1|Outcome|Placebo run-in|Part 2, Period 1, Placebo run-in phase: After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
609725|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609726|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609727|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609728|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609729|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609730|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609731|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609735|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609736|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609737|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609738|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609739|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609740|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609741|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609742|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609743|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609744|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609745|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609746|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609747|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609748|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609749|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609750|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609751|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609752|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609753|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609754|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609755|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609756|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609823|NCT00497874|B3|Baseline|Total|Total of all reporting groups
609824|NCT00497874|B2|Baseline|Usual Care|Usual primary care treatment
609757|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
609758|NCT00498433|E5|Reported Event|Part 2: Amlodipine|Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
609759|NCT00498433|E4|Reported Event|Part 2: Aliskiren|Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
609760|NCT00498433|E3|Reported Event|Part 2: Placebo run-in Period|After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
609761|NCT00498433|E2|Reported Event|Part 1: Amlodipine|All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.
609762|NCT00498433|E1|Reported Event|Part 1: Aliskiren|All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
609763|NCT00498368|B3|Baseline|Total|Total of all reporting groups
609764|NCT00498368|B2|Baseline|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609765|NCT00498368|B1|Baseline|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609766|NCT00498368|P2|Participant Flow|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609767|NCT00498368|P1|Participant Flow|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609768|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609769|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609770|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609771|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609772|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609773|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609774|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609775|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609825|NCT00497874|B1|Baseline|Intervention|Stage-based manual and three computer-tailored reports
609826|NCT00497874|P2|Participant Flow|Usual Care|Usual primary care treatment
619465|NCT00473655|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg
609776|NCT00498368|E2|Reported Event|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609777|NCT00498368|E1|Reported Event|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
609778|NCT00498355|B1|Baseline|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
609779|NCT00498355|P1|Participant Flow|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
609780|NCT00498355|O1|Outcome|Ranibizumab|Ranibizumab: 0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.
609781|NCT00498355|O1|Outcome|Ranibizumab|Ranibizumab: 0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.
609782|NCT00498355|O1|Outcome|Ranibizumab|Ranibizumab: 0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.
609783|NCT00498355|O1|Outcome|Ranibizumab|Ranibizumab: 0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.
609784|NCT00498355|O1|Outcome|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
609785|NCT00498355|E1|Reported Event|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
609786|NCT00498186|B1|Baseline|Rotigotine|Rotigotine trans-dermal patch
609787|NCT00498186|P1|Participant Flow|Rotigotine|Rotigotine trans-dermal patch
609788|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
609789|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
609790|NCT00498186|E1|Reported Event|Rotigotine|Rotigotine trans-dermal patch
609791|NCT00498173|B3|Baseline|Total|Total of all reporting groups
609792|NCT00498173|B2|Baseline|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609793|NCT00498173|B1|Baseline|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609794|NCT00498173|P3|Participant Flow|Atomoxetine (Open Label Trial)|Placebo-treated subjects from the randomized trial that don't respond to placebo will be offered an 8-week open-label trial of atomoxetine.
609795|NCT00498173|P2|Participant Flow|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609796|NCT00498173|P1|Participant Flow|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609797|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
609798|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
609799|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
609800|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
609801|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
609802|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
609803|NCT00498173|O1|Outcome|Open-label Trial|Participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial
609804|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609827|NCT00497874|P1|Participant Flow|Intervention|Stage-based manual and three computer-tailored reports
609828|NCT00497874|O2|Outcome|Usual Care|Usual primary care
609805|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609806|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609807|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609808|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609809|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609810|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609811|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609812|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609813|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609814|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609815|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609816|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609817|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609818|NCT00498173|O2|Outcome|Placebo|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609819|NCT00498173|O1|Outcome|Atomoxetine|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609820|NCT00498173|E3|Reported Event|Atomoxetine (Open Label Trial)|Placebo-treated subjects from the randomized trial that don’t respond to placebo will be offered an 8-week open-label trial of atomoxetine
609821|NCT00498173|E2|Reported Event|Placebo (Randomized)|"Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg."
609822|NCT00498173|E1|Reported Event|Atomoxetine (Randomized)|"Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.~Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4."
609829|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
609830|NCT00497874|O2|Outcome|Usual Care|Usual primary care
609831|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
609832|NCT00497874|O2|Outcome|Usual Care|Usual primary care
609833|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
609834|NCT00497874|O2|Outcome|Usual Care|Usual primary care
609835|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
609836|NCT00497874|O2|Outcome|Usual Care|Usual primary care treatment
609837|NCT00497874|O1|Outcome|Intervention|Stage-based manual and three computer-tailored reports
609838|NCT00497874|O2|Outcome|Usual Care|Usual primary care
609839|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
609840|NCT00497874|E2|Reported Event|Usual Care|Usual primary care treatment
609841|NCT00497874|E1|Reported Event|Intervention|Stage-based manual and three computer-tailored reports
609842|NCT00497796|B3|Baseline|Total|Total of all reporting groups
609843|NCT00497796|B2|Baseline|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609844|NCT00497796|B1|Baseline|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609845|NCT00497796|P2|Participant Flow|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609846|NCT00497796|P1|Participant Flow|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609847|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609848|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609849|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609850|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609851|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609852|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609853|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609854|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609855|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609856|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609857|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609858|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609859|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609860|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609861|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609862|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609863|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609864|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609865|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609866|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609867|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609868|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609869|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609870|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609871|NCT00497796|E2|Reported Event|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
609872|NCT00497796|E1|Reported Event|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
609873|NCT00497770|B5|Baseline|Total|Total of all reporting groups
609874|NCT00497770|B4|Baseline|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609875|NCT00497770|B3|Baseline|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609876|NCT00497770|B2|Baseline|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609877|NCT00497770|B1|Baseline|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
609878|NCT00497770|P4|Participant Flow|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609879|NCT00497770|P3|Participant Flow|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609880|NCT00497770|P2|Participant Flow|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609881|NCT00497770|P1|Participant Flow|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
609882|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609883|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609884|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609885|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609886|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609887|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609888|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609889|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
619466|NCT00473642|B4|Baseline|Total|Total of all reporting groups
609890|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609891|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609892|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609893|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609894|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609895|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609896|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609897|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609898|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609899|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609900|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609901|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609902|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609903|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609904|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609905|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609906|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609907|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609908|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609909|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609910|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609911|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609912|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609913|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609914|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609915|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609916|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609917|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
609918|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609919|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609920|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609921|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609922|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609923|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609924|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609925|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
609926|NCT00497770|E4|Reported Event|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
609927|NCT00497770|E3|Reported Event|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
609928|NCT00497770|E2|Reported Event|African American|African American participants receiving pemetrexed for 2nd line NSCLC
609929|NCT00497770|E1|Reported Event|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
609930|NCT00497198|B3|Baseline|Total|Total of all reporting groups
609931|NCT00497198|B2|Baseline|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609932|NCT00497198|B1|Baseline|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609933|NCT00497198|P2|Participant Flow|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609934|NCT00497198|P1|Participant Flow|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609935|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609936|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609937|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609938|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609939|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609940|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609941|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609942|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609943|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609944|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609945|NCT00497198|E2|Reported Event|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
609946|NCT00497198|E1|Reported Event|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
609947|NCT00497146|B3|Baseline|Total|Total of all reporting groups
609948|NCT00497146|B2|Baseline|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609949|NCT00497146|B1|Baseline|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609950|NCT00497146|P2|Participant Flow|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609951|NCT00497146|P1|Participant Flow|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609952|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609953|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609954|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609955|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609956|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609957|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609958|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609959|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609960|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609961|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609962|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609963|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609964|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609965|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609966|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609967|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
619467|NCT00473642|B3|Baseline|Ranibizumab|Ranibizumab monotherapy
609968|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609969|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609970|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609971|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609972|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609973|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609974|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609975|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609976|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609977|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609978|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609979|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609980|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609981|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609982|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609983|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609984|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609985|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609986|NCT00497146|E4|Reported Event|Placebo: Long-term Follow-up|Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609987|NCT00497146|E3|Reported Event|Paricalcitol: Long-term Follow-up|Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
609988|NCT00497146|E2|Reported Event|Placebo: Treatment Period|Participants received 2 placebo capsules once a day for up to 48 weeks.
609989|NCT00497146|E1|Reported Event|Paricalcitol: Treatment Period|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks.
609990|NCT00497081|B3|Baseline|Total|Total of all reporting groups
609991|NCT00497081|B2|Baseline|Placebo Comparator:|placebo 30 mg daily for 3 months
609992|NCT00497081|B1|Baseline|Active Comparator:|mirtazapine 30 mg daily for 3 months
609993|NCT00497081|P2|Participant Flow|Placebo Comparator:|placebo 30 mg daily for 3 months
609994|NCT00497081|P1|Participant Flow|Active Comparator:|mirtazapine 30 mg daily for 3 months
609995|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
609996|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
609997|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
609998|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
609999|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
610000|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
610001|NCT00497081|E2|Reported Event|Placebo Comparator:|placebo 30 mg daily for 3 months
610002|NCT00497081|E1|Reported Event|Active Comparator:|mirtazapine 30 mg daily for 3 months
610003|NCT00497055|B3|Baseline|Total|Total of all reporting groups
610004|NCT00497055|B2|Baseline|Placebo|placebo daily for 3 months
610005|NCT00497055|B1|Baseline|Aripiprazole|aripiprazole daily for 3 months
610006|NCT00497055|P2|Participant Flow|Placebo|Placebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.
610007|NCT00497055|P1|Participant Flow|Aripiprazole|Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
610008|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
610009|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
610010|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
610011|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
610012|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
610013|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
610014|NCT00497055|E2|Reported Event|Placebo|placebo daily for 3 months
610015|NCT00497055|E1|Reported Event|Aripiprazole|aripiprazole daily for 3 months
610016|NCT00496964|B3|Baseline|Total|Total of all reporting groups
610017|NCT00496964|B2|Baseline|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610018|NCT00496964|B1|Baseline|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610019|NCT00496964|P2|Participant Flow|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610020|NCT00496964|P1|Participant Flow|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610021|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610022|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610023|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610024|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610025|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610026|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610027|NCT00496964|O2|Outcome|Placebo Injection + Exercise|"Placebo injection + exercise~Placebo: Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome focusing on the knee & hip."
610028|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|"Subjects in this group received an Injection of Botulinum toxin A in the vastus lateralis of the study limb plus exercise program~Subjects received a single injection of 100 ml of Botulinum toxin A (Botulinum toxin type A) into the vastus lateralis muscle of the involved limb near the motor point followed by instruction in a home exercise program for knee and hip musculature that Exercises were performed for 12 weeks, with the number or repetitions and sets determined and progressed by a physical therapist based on reports of knee pain."
610029|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610030|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610031|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610032|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610033|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610034|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610035|NCT00496964|E2|Reported Event|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
610036|NCT00496964|E1|Reported Event|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
610037|NCT00496873|B1|Baseline|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
610038|NCT00496873|P1|Participant Flow|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
610039|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
610040|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
610041|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
610042|NCT00496873|E1|Reported Event|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
610043|NCT00496860|B4|Baseline|Total|Total of all reporting groups
610044|NCT00496860|B3|Baseline|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610045|NCT00496860|B2|Baseline|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
610046|NCT00496860|B1|Baseline|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610047|NCT00496860|P3|Participant Flow|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610048|NCT00496860|P2|Participant Flow|ALT-801 0.040 mg/kg/ Dose|0.040 mg/kg/dose of ALT-801
610049|NCT00496860|P1|Participant Flow|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610050|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610051|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
610052|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610053|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610054|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
610055|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610056|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610057|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
610058|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610059|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610060|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
610061|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610062|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610063|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
610064|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610065|NCT00496860|E3|Reported Event|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
610066|NCT00496860|E2|Reported Event|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
610067|NCT00496860|E1|Reported Event|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
610068|NCT00496834|B3|Baseline|Total|Total of all reporting groups
610069|NCT00496834|B2|Baseline|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
610070|NCT00496834|B1|Baseline|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
610071|NCT00496834|P2|Participant Flow|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
610072|NCT00496834|P1|Participant Flow|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
610073|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
610074|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
610075|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
610076|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
610094|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
619470|NCT00473642|P3|Participant Flow|Ranibizumab|Ranibizumab monotherapy
610077|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation."
610078|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation.
610079|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
610080|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
610081|NCT00496834|E2|Reported Event|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once."
610082|NCT00496834|E1|Reported Event|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once.
610083|NCT00496808|B1|Baseline|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
610084|NCT00496808|P1|Participant Flow|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
610085|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
610086|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
610087|NCT00496808|E1|Reported Event|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
610088|NCT00496782|B3|Baseline|Total|Total of all reporting groups
610089|NCT00496782|B2|Baseline|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610090|NCT00496782|B1|Baseline|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610091|NCT00496782|P2|Participant Flow|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610092|NCT00496782|P1|Participant Flow|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610093|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610186|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610095|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610096|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610097|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610098|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610099|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610100|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610101|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610102|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610103|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610104|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610105|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610106|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610107|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610108|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610187|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610361|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610109|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610110|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610111|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610112|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610113|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610114|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610115|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610116|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610117|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610118|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610119|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610120|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610121|NCT00496782|E2|Reported Event|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
610122|NCT00496782|E1|Reported Event|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
610123|NCT00496769|B3|Baseline|Total|Total of all reporting groups
610124|NCT00496769|B2|Baseline|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
619827|NCT00472797|E1|Reported Event|Non-Titrated|New formulation of rebif
610125|NCT00496769|B1|Baseline|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610126|NCT00496769|P2|Participant Flow|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
610127|NCT00496769|P1|Participant Flow|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610128|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
610129|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610130|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
610131|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610132|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
610133|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610134|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
610135|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610136|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
610137|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610138|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion
610139|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610140|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
610141|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610142|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
610143|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610144|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
610145|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610146|NCT00496769|E2|Reported Event|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
612302|NCT00490945|E5|Reported Event|100 mg VEC-162|Randomized to 100 mg VEC-162
610147|NCT00496769|E1|Reported Event|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
610148|NCT00496730|B3|Baseline|Total|Total of all reporting groups
610149|NCT00496730|B2|Baseline|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
610150|NCT00496730|B1|Baseline|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
610151|NCT00496730|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
610152|NCT00496730|P1|Participant Flow|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
610153|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
610154|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
610155|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
610156|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
610157|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
610158|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
610159|NCT00496730|E2|Reported Event|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
610160|NCT00496730|E1|Reported Event|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
610161|NCT00496626|B3|Baseline|Total|Total of all reporting groups
610162|NCT00496626|B2|Baseline|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610163|NCT00496626|B1|Baseline|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610164|NCT00496626|P2|Participant Flow|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610165|NCT00496626|P1|Participant Flow|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610166|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610167|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610168|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610169|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610170|NCT00496626|O4|Outcome|Placebo Group (Month 7)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610171|NCT00496626|O3|Outcome|Vaccine (Gardasil®) Group (Month 7)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610172|NCT00496626|O2|Outcome|Placebo Group (Day 1)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610173|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group (Day 1)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610174|NCT00496626|E2|Reported Event|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610175|NCT00496626|E1|Reported Event|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
610176|NCT00496587|B1|Baseline|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
610177|NCT00496587|P1|Participant Flow|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
610178|NCT00496587|O1|Outcome|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
610179|NCT00496587|O1|Outcome|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
610180|NCT00496587|O1|Outcome|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
610181|NCT00496587|E1|Reported Event|Capecitabine + Gemcitabine + Bevacizumab|Capecitabine 800 mg/m^2 orally twice daily Days 1-21; Gemcitabine 900 mg/m^2 intravenous (IV) Days 1 &15 and Bevacizumab 10 mg/kg IV Days 1 & 15.
610182|NCT00496483|B1|Baseline|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610183|NCT00496483|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22 patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL."
610184|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610185|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
619828|NCT00472732|B3|Baseline|Total|Total of all reporting groups
610188|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610189|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610190|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610191|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610192|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610193|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610194|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
610195|NCT00496483|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were entrolled into the study and one withdrew consent right after screening. Therefore 59 patients are inlcuded in the ITT safety set."
610196|NCT00496483|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were enrolled into the study, but only 51 were dosed with LCP-Tacro."
610197|NCT00496470|B3|Baseline|Total|Total of all reporting groups
610198|NCT00496470|B2|Baseline|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610199|NCT00496470|B1|Baseline|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610200|NCT00496470|P2|Participant Flow|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610201|NCT00496470|P1|Participant Flow|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610202|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610203|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610204|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610205|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610206|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610207|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610208|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610209|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610210|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610211|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610212|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610213|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610214|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610215|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610216|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610217|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610218|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610219|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610220|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610221|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610222|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610223|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610224|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610509|NCT00495586|B2|Baseline|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
610225|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610226|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610227|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610228|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610229|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610230|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610231|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610232|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610233|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610234|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610235|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610236|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610237|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610238|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610239|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610240|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610241|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610242|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610243|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610244|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610245|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610246|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610247|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610248|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610249|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610250|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610251|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610252|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610253|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610254|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610255|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610256|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610257|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610258|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610259|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610260|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610261|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610262|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610263|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610264|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610265|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610266|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610267|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610268|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610269|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610270|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610271|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610272|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610273|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610274|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610275|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610276|NCT00496470|E2|Reported Event|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
610277|NCT00496470|E1|Reported Event|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
610278|NCT00496379|B1|Baseline|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610279|NCT00496379|P1|Participant Flow|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610280|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610281|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610282|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610283|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610284|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610285|NCT00496379|E1|Reported Event|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
610286|NCT00496366|B1|Baseline|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
610287|NCT00496366|P1|Participant Flow|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
610288|NCT00496366|O1|Outcome|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
610289|NCT00496366|O1|Outcome|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
610290|NCT00496366|E1|Reported Event|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
610291|NCT00496340|B1|Baseline|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610356|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610357|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610292|NCT00496340|P1|Participant Flow|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610293|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610294|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610295|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610296|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610297|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610298|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610299|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610300|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610358|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610301|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610302|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610303|NCT00496340|E1|Reported Event|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
610304|NCT00496262|B1|Baseline|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610305|NCT00496262|P1|Participant Flow|Human Fibrinogen Concentrate|All enrolled subjects received a single IV infusion of 70 mg/kg body weight of human fibrinogen concentrate.
610306|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610307|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610308|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610309|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610310|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610311|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610312|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610313|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610314|NCT00496262|O2|Outcome|1 Hour Post-infusion|1 hour after end of infusion
610315|NCT00496262|O1|Outcome|Pre-infusion|≤ 2 hours before start of infusion
610316|NCT00496262|E1|Reported Event|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
610317|NCT00496197|B1|Baseline|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610318|NCT00496197|P1|Participant Flow|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610319|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610320|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610321|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610322|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610323|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610324|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610325|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610326|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610327|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610328|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610329|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610330|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610331|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610332|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610333|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610359|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610360|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610334|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610335|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610336|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610337|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610338|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610339|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610340|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610341|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610342|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610343|NCT00496197|E1|Reported Event|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
610344|NCT00496080|B1|Baseline|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
610345|NCT00496080|P1|Participant Flow|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
610346|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
610347|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
610348|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
610349|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
610350|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
610351|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
610352|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
610353|NCT00496080|E1|Reported Event|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
610354|NCT00496054|B1|Baseline|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610355|NCT00496054|P1|Participant Flow|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610362|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610363|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610364|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610365|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610366|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610367|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610368|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610369|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610370|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610371|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610372|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610373|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610374|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610375|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610376|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610377|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610378|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610379|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610380|NCT00496054|E1|Reported Event|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
610381|NCT00495820|B3|Baseline|Total|Total of all reporting groups
610382|NCT00495820|B2|Baseline|Arm 2|"Placebo~Placebo: Standard inactive pill."
610383|NCT00495820|B1|Baseline|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
610384|NCT00495820|P2|Participant Flow|Arm 2|"Placebo~Placebo: Standard inactive pill."
610385|NCT00495820|P1|Participant Flow|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
610386|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
610387|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
610388|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
610389|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
610390|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
610391|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
610392|NCT00495820|E2|Reported Event|Placebo Group|Subjects randomized to this group received methylphenidate
610393|NCT00495820|E1|Reported Event|Methylphenidate Group|Subjects randomized to this group received methylphenidate
610394|NCT00495794|B3|Baseline|Total|Total of all reporting groups
610395|NCT00495794|B2|Baseline|Usual Care|Eligible patients receive usual care
610396|NCT00495794|B1|Baseline|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
610397|NCT00495794|P2|Participant Flow|Usual Care|Eligible patients receive usual care
610398|NCT00495794|P1|Participant Flow|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
610399|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
610400|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
610401|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
610441|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610442|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610402|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
610403|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
610404|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
610405|NCT00495794|E2|Reported Event|Usual Care|Eligible patients receive usual care
610406|NCT00495794|E1|Reported Event|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
610407|NCT00495755|B1|Baseline|Campath (Alemtuzumab)|
610408|NCT00495755|P1|Participant Flow|Campath (Alemtuzumab)|3 dose cohorts entered
610409|NCT00495755|O1|Outcome|Response|
610410|NCT00495755|O1|Outcome|Maximum Tolerated Dose (MTD)|
610411|NCT00495755|E1|Reported Event|Campath (Alemtuzumab)|
610412|NCT00495677|B8|Baseline|Total|Total of all reporting groups
610413|NCT00495677|B7|Baseline|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610414|NCT00495677|B6|Baseline|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610415|NCT00495677|B5|Baseline|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610416|NCT00495677|B4|Baseline|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610417|NCT00495677|B3|Baseline|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610418|NCT00495677|B2|Baseline|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610419|NCT00495677|B1|Baseline|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610420|NCT00495677|P7|Participant Flow|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610421|NCT00495677|P6|Participant Flow|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610422|NCT00495677|P5|Participant Flow|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610423|NCT00495677|P4|Participant Flow|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610424|NCT00495677|P3|Participant Flow|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610425|NCT00495677|P2|Participant Flow|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610426|NCT00495677|P1|Participant Flow|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610427|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610428|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610429|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610430|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610431|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610432|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610433|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610434|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610435|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610436|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610437|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610438|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610439|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610440|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610443|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610444|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610445|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610446|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610447|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610448|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610449|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610450|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610451|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610452|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610453|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610454|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610455|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610456|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610457|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610458|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610459|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610460|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610461|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610462|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610463|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610464|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610465|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610466|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610467|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610468|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610469|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610470|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610471|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610472|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610473|NCT00495677|E7|Reported Event|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610474|NCT00495677|E6|Reported Event|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610475|NCT00495677|E5|Reported Event|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610476|NCT00495677|E4|Reported Event|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610477|NCT00495677|E3|Reported Event|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
610478|NCT00495677|E2|Reported Event|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610479|NCT00495677|E1|Reported Event|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
610480|NCT00495625|B1|Baseline|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610481|NCT00495625|P1|Participant Flow|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610482|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610483|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610484|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610485|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610486|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610487|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610488|NCT00495625|E1|Reported Event|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
610489|NCT00495612|B3|Baseline|Total|Total of all reporting groups
610490|NCT00495612|B2|Baseline|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610491|NCT00495612|B1|Baseline|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610492|NCT00495612|P2|Participant Flow|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610493|NCT00495612|P1|Participant Flow|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610494|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610495|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610496|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610497|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610498|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610499|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610500|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610501|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610502|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610503|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610504|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610505|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610506|NCT00495612|E2|Reported Event|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
610507|NCT00495612|E1|Reported Event|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
610508|NCT00495586|B3|Baseline|Total|Total of all reporting groups
610511|NCT00495586|P2|Participant Flow|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
610512|NCT00495586|P1|Participant Flow|Placebo|Placebo pills t.i.d. for 8 days
610513|NCT00495586|O2|Outcome|Placebo|Ninety exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (90/123: 73.2%)
610514|NCT00495586|O1|Outcome|Amoxicillin and Clavulanic Acid|Eighty-three exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (83/143: 58%)
610515|NCT00495586|O2|Outcome|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
610516|NCT00495586|O1|Outcome|Placebo|Placebo pills t.i.d. for 8 days
610517|NCT00495586|E2|Reported Event|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
610518|NCT00495586|E1|Reported Event|Placebo|Placebo pills t.i.d. for 8 days
610519|NCT00495521|B3|Baseline|Total|Total of all reporting groups
610520|NCT00495521|B2|Baseline|Placebo Granules|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610521|NCT00495521|B1|Baseline|4-Aminosalicylic Acid Extended Release Granules|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610522|NCT00495521|P2|Participant Flow|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610523|NCT00495521|P1|Participant Flow|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610524|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610525|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610526|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610527|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610528|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610529|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610530|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610531|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610532|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610533|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610534|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610535|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610536|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610537|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610538|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610539|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610540|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610541|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610542|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610543|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610544|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610545|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610546|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610547|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610548|NCT00495521|O2|Outcome|Placebo|Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
610549|NCT00495521|O1|Outcome|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610550|NCT00495521|E2|Reported Event|Placebo|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610551|NCT00495521|E1|Reported Event|Active|Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
610552|NCT00495495|B1|Baseline|Ozone Treatment/Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
610553|NCT00495495|P1|Participant Flow|Ozone Treatment and Placebo Treatment|60-second Ozone device treatment compared to 60-second Placebo device treatment. Study utilized split-mouth design. The paired treatment assignment for the two teeth within each subject was performed according to a randomization table provided by the Biometrician. Randomization of teeth to Ozone treatment or Placebo treatment was stratifed according to tooth similarity.
610554|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
610555|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
610556|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
610557|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
610558|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
610559|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
610560|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
610561|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
610562|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
610563|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
610564|NCT00495495|E1|Reported Event|Ozone Treatment and Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randominzed to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
610565|NCT00495469|B8|Baseline|Total|Total of all reporting groups
610566|NCT00495469|B7|Baseline|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610567|NCT00495469|B6|Baseline|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610568|NCT00495469|B5|Baseline|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610569|NCT00495469|B4|Baseline|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610570|NCT00495469|B3|Baseline|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610571|NCT00495469|B2|Baseline|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610572|NCT00495469|B1|Baseline|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
610573|NCT00495469|P7|Participant Flow|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610574|NCT00495469|P6|Participant Flow|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610575|NCT00495469|P5|Participant Flow|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610576|NCT00495469|P4|Participant Flow|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610635|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610577|NCT00495469|P3|Participant Flow|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610578|NCT00495469|P2|Participant Flow|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 milligrams (mg) each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610579|NCT00495469|P1|Participant Flow|Placebo|Participants received 2 placebo tablets matching for GSK189075 twice daily (BID) before breakfast and dinner and 1 placebo capsule matching for Pioglitazone once daily (QD) before breakfast for 12 weeks
610580|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610581|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610582|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610583|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610584|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610585|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610586|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610587|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610588|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610589|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610590|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610591|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610592|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610593|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610594|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610595|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610596|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610597|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610598|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610599|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610600|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610601|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610602|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610603|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610604|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610605|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610759|NCT00495131|B3|Baseline|Total|Total of all reporting groups
610606|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610607|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610608|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610609|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610610|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610611|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610612|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610613|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610614|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610615|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610616|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610617|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610618|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610619|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610620|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610621|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610622|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610623|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610624|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610625|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610626|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610627|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610628|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610629|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610630|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610631|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610632|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610633|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610634|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610975|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610636|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610637|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610638|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610639|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610640|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610641|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610642|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610643|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610644|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610645|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610646|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610647|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610648|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610649|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610650|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610651|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610652|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610653|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610654|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610655|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610656|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610657|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610658|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610659|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610660|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610661|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610662|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610663|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610664|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610976|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610665|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610666|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610667|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610668|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610669|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610670|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610671|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610672|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610673|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610674|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610675|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610676|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610677|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610678|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610679|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610680|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610681|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610682|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610683|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610684|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610685|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610686|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610687|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610688|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610689|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610690|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610691|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610692|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610693|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610977|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610694|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610695|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610696|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610697|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610698|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610699|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610700|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610701|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610702|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610703|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610704|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610705|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
610706|NCT00495469|O7|Outcome|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610707|NCT00495469|O6|Outcome|GSK189075 250 mg BID|Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610708|NCT00495469|O5|Outcome|GSK189075 1000 mg QD|Participants received 2 tablets of 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610709|NCT00495469|O4|Outcome|GSK189075 500 mg QD|Participants received 2 tablets of 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610710|NCT00495469|O3|Outcome|GSK189075 250 mg QD|Participants received 2 tablets of 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610711|NCT00495469|O2|Outcome|GSK189075 100 mg QD|Participants received 2 tablets of 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610712|NCT00495469|O1|Outcome|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks
610713|NCT00495469|E7|Reported Event|Pioglitazone 30 mg QD|Participants received 2 placebo tablets matching GSK189075, 1 capsule of Pioglitazone 30 mg before breakfast and 2 placebo tablets matching GSK189075 before dinner daily for 12 weeks.
610714|NCT00495469|E6|Reported Event|GSK189075 250 mg BID|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 tablets of GSK189075 125 mg each before dinner daily for 12 weeks.
610715|NCT00495469|E5|Reported Event|GSK189075 1000 mg QD|Participants received 2 tablets of GSK189075 500 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610716|NCT00495469|E4|Reported Event|GSK189075 500 mg QD|Participants received 2 tablets of GSK189075 250 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610717|NCT00495469|E3|Reported Event|GSK189075 250 mg QD|Participants received 2 tablets of GSK189075 125 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610718|NCT00495469|E2|Reported Event|GSK189075 100 mg QD|Participants received 2 tablets of GSK189075 50 mg each, 1 placebo capsule matching for Pioglitazone before breakfast and 2 placebo tablets matching for GSK189075 before dinner daily for 12 weeks.
610719|NCT00495469|E1|Reported Event|Placebo|Participants received 2 placebo tablets matching for GSK189075 BID before breakfast and dinner and 1 placebo capsule matching for Pioglitazone QD before breakfast for 12 weeks.
610720|NCT00495391|B3|Baseline|Total|Total of all reporting groups
610721|NCT00495391|B2|Baseline|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610760|NCT00495131|B2|Baseline|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
612303|NCT00490945|E4|Reported Event|50 mg VEC-162|Randomized to 50 mg VEC-162
610722|NCT00495391|B1|Baseline|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610723|NCT00495391|P2|Participant Flow|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610724|NCT00495391|P1|Participant Flow|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610725|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610726|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610727|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610728|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610729|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610730|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610731|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610732|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610733|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610734|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
620589|NCT00470106|B5|Baseline|Total|Total of all reporting groups
610735|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610736|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610737|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610738|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610739|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610740|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610741|NCT00495391|E2|Reported Event|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
610742|NCT00495391|E1|Reported Event|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
610743|NCT00495222|B1|Baseline|Tissue Plication|
610744|NCT00495222|P1|Participant Flow|Tissue Plication|
610745|NCT00495222|O1|Outcome|Tissue Plication|
610746|NCT00495157|B4|Baseline|Total|Total of all reporting groups
610747|NCT00495157|B3|Baseline|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610748|NCT00495157|B2|Baseline|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610749|NCT00495157|B1|Baseline|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610750|NCT00495157|P3|Participant Flow|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610751|NCT00495157|P2|Participant Flow|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610752|NCT00495157|P1|Participant Flow|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610753|NCT00495157|O3|Outcome|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610754|NCT00495157|O2|Outcome|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610755|NCT00495157|O1|Outcome|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610756|NCT00495157|E3|Reported Event|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610757|NCT00495157|E2|Reported Event|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610758|NCT00495157|E1|Reported Event|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
610761|NCT00495131|B1|Baseline|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
610762|NCT00495131|P2|Participant Flow|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
610763|NCT00495131|P1|Participant Flow|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
610764|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
610765|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
610766|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
610767|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
610768|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
610769|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
610770|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
610771|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
610772|NCT00495079|B1|Baseline|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
610773|NCT00495079|P1|Participant Flow|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
610774|NCT00495079|O1|Outcome|Marqibo|"Proportion if subjects who achieved CR+CRi as determined by the IRRC using the International Working Group (IWG)Criteria. The IRRC Evaluable analysis set(n=53) included subjects who received at least 1 dose of study drug and reviewable data.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+/-10 minutes) every 7 days (+/-3days)"
610775|NCT00495079|O1|Outcome|Marqibo|"The population analyzed included all subjects who received at least one dose of Marqibo. Subjects who did not die had their survival times censored on the date of last contact. The K-M method was used to estimate the distribution of overall survival.~Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes)every 7 days (+/- 3 days)"
610776|NCT00495079|O1|Outcome|Marqibo|"Duration of response derived using the IRRC determined response dates for subjects who achieved CR or CRi (n=8). The K-M product limit method was used to estimate the median event time.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+- 10 minutes)every 7 days (+/- 3 days)"
610777|NCT00495079|O1|Outcome|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
610778|NCT00495079|E1|Reported Event|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
610779|NCT00494975|B3|Baseline|Total|Total of all reporting groups
610780|NCT00494975|B2|Baseline|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
610781|NCT00494975|B1|Baseline|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
610782|NCT00494975|P2|Participant Flow|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
610783|NCT00494975|P1|Participant Flow|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
610784|NCT00494975|O2|Outcome|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
610785|NCT00494975|O1|Outcome|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
610786|NCT00494975|E2|Reported Event|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
610787|NCT00494975|E1|Reported Event|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
610788|NCT00494871|B3|Baseline|Total|Total of all reporting groups
610789|NCT00494871|B2|Baseline|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610790|NCT00494871|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610791|NCT00494871|P2|Participant Flow|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610792|NCT00494871|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610793|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610794|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610795|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610796|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610797|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610798|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610799|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610800|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610801|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610802|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610803|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610804|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610805|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610806|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610807|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610808|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610809|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610810|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610811|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610812|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610813|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610814|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610815|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
610816|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
610817|NCT00494871|E4|Reported Event|RG4: Warfarin FU Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
610818|NCT00494871|E3|Reported Event|RG3: Rivaroxaban Follow-up (FU) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
610819|NCT00494871|E2|Reported Event|RG2: Warfarin DB Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
610820|NCT00494871|E1|Reported Event|RG1: Rivaroxaban Double-blind (DB) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
610821|NCT00494806|B3|Baseline|Total|Total of all reporting groups
610822|NCT00494806|B2|Baseline|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610823|NCT00494806|B1|Baseline|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610824|NCT00494806|P2|Participant Flow|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610825|NCT00494806|P1|Participant Flow|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610826|NCT00494806|O2|Outcome|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610827|NCT00494806|O1|Outcome|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610828|NCT00494806|E2|Reported Event|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610829|NCT00494806|E1|Reported Event|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
610830|NCT00494780|B3|Baseline|Total|Total of all reporting groups
610831|NCT00494780|B2|Baseline|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610832|NCT00494780|B1|Baseline|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610833|NCT00494780|P2|Participant Flow|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610834|NCT00494780|P1|Participant Flow|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610835|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610836|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610837|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610838|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610839|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610840|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610841|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610842|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610843|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610844|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610845|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610846|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610847|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610848|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610849|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610850|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610851|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610852|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610853|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610854|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610855|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610856|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610857|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610858|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610859|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610860|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610861|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610862|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610863|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610864|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610865|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610866|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610867|NCT00494780|E4|Reported Event|1000 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610868|NCT00494780|E3|Reported Event|500 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610869|NCT00494780|E2|Reported Event|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610870|NCT00494780|E1|Reported Event|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
610871|NCT00494676|B1|Baseline|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
610872|NCT00494676|P2|Participant Flow|Sham Prism Glasses Then Real|Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks
610873|NCT00494676|P1|Participant Flow|Real Prism Glasses Then Sham|Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks
610874|NCT00494676|O1|Outcome|Entire Study Population Who Discontinued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
610875|NCT00494676|O1|Outcome|Entire Study Population Who Continued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
610876|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
610877|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
610878|NCT00494676|E1|Reported Event|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
610879|NCT00494585|B1|Baseline|CEP-701|80 mg orally twice daily for 30 days
610880|NCT00494585|P1|Participant Flow|CEP-701|80 mg orally twice daily for 30 days
610881|NCT00494585|O1|Outcome|CEP-701|80 mg orally twice daily for 30 days
610882|NCT00494585|E1|Reported Event|CEP-701|80 mg orally twice daily for 30 days
610883|NCT00494507|B5|Baseline|Total|Total of all reporting groups
610884|NCT00494507|B4|Baseline|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610885|NCT00494507|B3|Baseline|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610886|NCT00494507|B2|Baseline|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610887|NCT00494507|B1|Baseline|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610888|NCT00494507|P4|Participant Flow|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610889|NCT00494507|P3|Participant Flow|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610890|NCT00494507|P2|Participant Flow|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610891|NCT00494507|P1|Participant Flow|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610892|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610893|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610894|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
620736|NCT00469079|O3|Outcome|Camel Snus|Camel Snus - oral tobacco product
610895|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610896|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610897|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610898|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610899|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610900|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610901|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610902|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610903|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610904|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
610905|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
610906|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
610907|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
610908|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610909|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610910|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
610911|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
610912|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
610913|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
610914|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
610915|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
610916|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610917|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610918|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610919|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610920|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610921|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610922|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610923|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610924|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610925|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610926|NCT00494507|O2|Outcome|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610927|NCT00494507|O1|Outcome|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
610928|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610929|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610930|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
610931|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
610932|NCT00494507|E6|Reported Event|HOP Open-Label Dichlorphenamide|Hypokalemic participants received Dichlorphenamide for the 52 week open-label phase.
610933|NCT00494507|E5|Reported Event|HOP Double-Blind Placebo|Hypokalemic participants were randomized to Placebo for the 9 week double-blind phase.
610934|NCT00494507|E4|Reported Event|HOP Double-Blind Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
610935|NCT00494507|E3|Reported Event|HYP Open-Label Dichlorphenamide|Hyperkalemic participants received Dichlorphenamide for the 52 week open-label phase.
610936|NCT00494507|E2|Reported Event|HYP Double-Blind Placebo|Hyperkalemic participants were randomized to Placebo for the 9 week double-blind phase.
610937|NCT00494507|E1|Reported Event|HYP Double-Blind Dichlorphenamide|Hyperkalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
610938|NCT00494494|B3|Baseline|Total|Total of all reporting groups
610939|NCT00494494|B2|Baseline|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610940|NCT00494494|B1|Baseline|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610941|NCT00494494|P2|Participant Flow|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610942|NCT00494494|P1|Participant Flow|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610943|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610944|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610945|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610946|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610947|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610948|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610949|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610950|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610951|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610952|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610953|NCT00494494|E2|Reported Event|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
610954|NCT00494494|E1|Reported Event|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
610955|NCT00494481|B3|Baseline|Total|Total of all reporting groups
610956|NCT00494481|B2|Baseline|Placebo Plus Docetaxel|placebo plus docetaxel
610957|NCT00494481|B1|Baseline|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
610958|NCT00494481|P2|Participant Flow|Placebo Plus Docetaxel|placebo plus docetaxel
610959|NCT00494481|P1|Participant Flow|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
610960|NCT00494481|O2|Outcome|Placebo Plus Docetaxel|placebo plus docetaxel
610961|NCT00494481|O1|Outcome|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
610962|NCT00494481|E2|Reported Event|Placebo Plus Docetaxel|placebo plus docetaxel
610963|NCT00494481|E1|Reported Event|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
610964|NCT00494442|B3|Baseline|Total|Total of all reporting groups
610965|NCT00494442|B2|Baseline|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610966|NCT00494442|B1|Baseline|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610967|NCT00494442|P2|Participant Flow|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610968|NCT00494442|P1|Participant Flow|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610969|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610970|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610971|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610972|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610973|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610974|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610978|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610979|NCT00494442|E2|Reported Event|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
610980|NCT00494442|E1|Reported Event|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
610981|NCT00494299|B3|Baseline|Total|Total of all reporting groups
610982|NCT00494299|B2|Baseline|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
610983|NCT00494299|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
610984|NCT00494299|P2|Participant Flow|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
610985|NCT00494299|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
610986|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
610987|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
610988|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
610989|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
610990|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
610991|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
610992|NCT00494299|E2|Reported Event|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
610993|NCT00494299|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
610994|NCT00494234|B3|Baseline|Total|Total of all reporting groups
610995|NCT00494234|B2|Baseline|AZD2281 400 mg|
610996|NCT00494234|B1|Baseline|AZD2281 100 mg|
610997|NCT00494234|P2|Participant Flow|Olaparib 400 mg bd|Full Analysis Set
610998|NCT00494234|P1|Participant Flow|Olaparib 100 mg bd|Full Analysis Set
610999|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Patients who compled 6 cycles of treatment
611000|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Patients who compled 6 cycles of treatment
611001|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
611002|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
611003|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
611004|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
611005|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
611006|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
611007|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Number of responders
611008|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Number of responders
611009|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
611010|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
611011|NCT00494234|E2|Reported Event|AZD2281 400 mg|
611012|NCT00494234|E1|Reported Event|AZD2281 100 mg|
611013|NCT00494221|B4|Baseline|Total|Total of all reporting groups
611014|NCT00494221|B3|Baseline|Placebo|FOLFOX + Placebo
611015|NCT00494221|B2|Baseline|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
611016|NCT00494221|B1|Baseline|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
611017|NCT00494221|P3|Participant Flow|Placebo|FOLFOX + Placebo
611018|NCT00494221|P2|Participant Flow|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
611019|NCT00494221|P1|Participant Flow|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
611020|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
611021|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
611022|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
611023|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
611024|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
611025|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
611026|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
611027|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
611028|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
611029|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
611030|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
611031|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
611032|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
611033|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
611034|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
611035|NCT00494221|E3|Reported Event|Placebo|Placebo
611036|NCT00494221|E2|Reported Event|Cediranib 30 mg|Cediranib 30 mg
611037|NCT00494221|E1|Reported Event|Cediranib 20 mg|Cediranib 20 mg
611038|NCT00494143|B1|Baseline|CESR, Prescribed, Conventional|all subjects were randomized to each of the three interventions
611078|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611039|NCT00494143|P6|Participant Flow|CESR, Conventional, Prescribed|The individuals in this group were randomized to the prosthetic foot sequence, CESR foot, Conventional foot followed by Prescribed prosthetic foot.
611040|NCT00494143|P5|Participant Flow|CESR, Prescribed, Conventional|This arm included the individuals who were randomized to the prosthetic foot sequence, CESR foot followed by Prescribed foot, followed by Conventional foot.
611041|NCT00494143|P4|Participant Flow|Prescribed, Conventional, CESR|This arm included individuals who were randomized to the sequence, Prescribed prosthetic foot, conventional foot, CESR foot
611042|NCT00494143|P3|Participant Flow|Prescribed, CESR, Conventional|The randomized sequence of this arm was the Prescribed prosthetic foot, followed by the CESR foot followed by the Conventional prosthetic foot
611043|NCT00494143|P2|Participant Flow|Conventional, CESR, Prescribed|The randomized sequence of prosthetic use in this arm was Conventional foot, followed by CESR foot, followed by Prescribed.
611044|NCT00494143|P1|Participant Flow|Conventional, Prescribed, CESR|this is a randomized arm where the sequence of prosthetic use was their conventional foot, followed by prescribed foot, followed by the CESR foot
611045|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results while wearing the prescribed prosthetic foot
611046|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results while wearing the conventional prosthetic foot
611047|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
611048|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results with prescribed prosthetic foot
611049|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results with the conventional prosthetic foot
611050|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
611051|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|subjects wearing the prescribed prosthetic foot
611052|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|subjects wearing the conventional prosthetic foot
611053|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
611054|NCT00494143|E3|Reported Event|Arm 2 Prescribed Prosthetic Foot|subjects randomized to the prescribed prosthetic foot
611055|NCT00494143|E2|Reported Event|Arm 1 Conventional Prosthetic Foot|subjects randomized to the conventional prosthetic foot
611056|NCT00494143|E1|Reported Event|Arm 3 CESR Prosthetic Foot|subjects randomized to the CESR prosthetic foot
611057|NCT00494091|B3|Baseline|Total|Total of all reporting groups
611058|NCT00494091|B2|Baseline|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611059|NCT00494091|B1|Baseline|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611060|NCT00494091|P2|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611061|NCT00494091|P1|Participant Flow|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611062|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611063|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611064|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611065|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611066|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611067|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611068|NCT00494091|O2|Outcome|Temsirolimus 25 mg IV|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611069|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611070|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611071|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611072|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611073|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611074|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611075|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611076|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611077|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611079|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611080|NCT00494091|E2|Reported Event|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611081|NCT00494091|E1|Reported Event|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
611082|NCT00494026|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611083|NCT00494026|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611084|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611085|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611086|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611087|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611088|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611089|NCT00494026|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
611090|NCT00494013|B3|Baseline|Total|Total of all reporting groups
611091|NCT00494013|B2|Baseline|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611092|NCT00494013|B1|Baseline|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611093|NCT00494013|P2|Participant Flow|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611094|NCT00494013|P1|Participant Flow|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611095|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611096|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611097|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611098|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611099|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611100|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611101|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611102|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611103|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611104|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611105|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611106|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611107|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611108|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611109|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611110|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611111|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611112|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611113|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611114|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611115|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611116|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611117|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611118|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611119|NCT00494013|E2|Reported Event|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
611120|NCT00494013|E1|Reported Event|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
611121|NCT00493974|B3|Baseline|Total|Total of all reporting groups
611122|NCT00493974|B2|Baseline|Placebo|Matching placebo 4 times a day
611123|NCT00493974|B1|Baseline|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611124|NCT00493974|P2|Participant Flow|Placebo|Matching placebo 4 times a day
611125|NCT00493974|P1|Participant Flow|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611126|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
611127|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611128|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
611129|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611130|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
611131|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611132|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
611133|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611134|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
611135|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611136|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
611137|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611138|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
611139|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611140|NCT00493974|E2|Reported Event|Placebo|Matching placebo 4 times a day
611141|NCT00493974|E1|Reported Event|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
611142|NCT00493805|B1|Baseline|Total for Interventional Arm and Non Interventional Arm|
611143|NCT00493805|P2|Participant Flow|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
611144|NCT00493805|P1|Participant Flow|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
611145|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
611146|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
611147|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
611148|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
611149|NCT00493805|E2|Reported Event|Interventional Arm HOMA IR >2|
611150|NCT00493805|E1|Reported Event|Non Interventional Arm HOMA IR <=2|
611151|NCT00493779|B1|Baseline|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
611152|NCT00493779|P1|Participant Flow|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
611153|NCT00493779|O1|Outcome|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
611154|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
611155|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
611156|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
611157|NCT00493779|E1|Reported Event|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
611158|NCT00493649|B1|Baseline|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
611159|NCT00493649|P1|Participant Flow|TC+H|This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care.
611160|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
611161|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
611162|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
611163|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
611164|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
611165|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
611166|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
611167|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
611168|NCT00493649|E1|Reported Event|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
611169|NCT00493636|B3|Baseline|Total|Total of all reporting groups
611170|NCT00493636|B2|Baseline|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611171|NCT00493636|B1|Baseline|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611172|NCT00493636|P2|Participant Flow|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611173|NCT00493636|P1|Participant Flow|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611174|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611221|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611222|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611175|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611176|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611177|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611178|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611179|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611180|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611181|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611182|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611183|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611223|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611184|NCT00493636|E2|Reported Event|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611185|NCT00493636|E1|Reported Event|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
611186|NCT00493454|B1|Baseline|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
611187|NCT00493454|P1|Participant Flow|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
611188|NCT00493454|O1|Outcome|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
611189|NCT00493454|E1|Reported Event|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
611190|NCT00493311|B3|Baseline|Total|Total of all reporting groups
611191|NCT00493311|B2|Baseline|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611192|NCT00493311|B1|Baseline|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611193|NCT00493311|P2|Participant Flow|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611194|NCT00493311|P1|Participant Flow|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611195|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611196|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611197|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611198|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611199|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611200|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611201|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611202|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611203|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611204|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611205|NCT00493311|E2|Reported Event|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
611206|NCT00493311|E1|Reported Event|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
611207|NCT00493285|B7|Baseline|TOTAL|Total of all reporting groups
611208|NCT00493285|B6|Baseline|10^6 PLACEBO|
611209|NCT00493285|B5|Baseline|10^6 MEDI-534|
611210|NCT00493285|B4|Baseline|10^5 PLACEBO|
611211|NCT00493285|B3|Baseline|10^5 MEDI-534|
611212|NCT00493285|B2|Baseline|10^4 PLACEBO|
611213|NCT00493285|B1|Baseline|10^4 MEDI-534|
611214|NCT00493285|P6|Participant Flow|10^6 PLACEBO|
611215|NCT00493285|P5|Participant Flow|10^6 MEDI-534|
611216|NCT00493285|P4|Participant Flow|10^5 PLACEBO|
611217|NCT00493285|P3|Participant Flow|10^5 MEDI-534|
611218|NCT00493285|P2|Participant Flow|10^4 PLACEBO|
611219|NCT00493285|P1|Participant Flow|10^4 MEDI-534|
611220|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611224|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611225|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611226|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611227|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611228|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611229|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611230|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611231|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611232|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611233|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611234|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611235|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611236|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611237|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611238|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611239|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611240|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611241|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611242|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611243|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611244|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611245|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611246|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611247|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611248|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611249|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611250|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611251|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611252|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611253|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611254|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611255|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611256|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611257|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611258|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611294|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611259|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611260|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611261|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611262|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611263|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611264|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611265|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611266|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611267|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611268|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611269|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611270|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611271|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611272|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611273|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611274|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611275|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611276|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611277|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611278|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611279|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611280|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611281|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611282|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611283|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611284|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611285|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611286|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611287|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611288|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611289|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611290|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611291|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611292|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611293|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
612304|NCT00490945|E3|Reported Event|20 mg VEC-162|Randomized to 20 mg VEC-162
611295|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611296|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611297|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611298|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611299|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611300|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611301|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611302|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611303|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611304|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611305|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611306|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611307|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611308|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611309|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611310|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611311|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611312|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611313|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611314|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611315|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611316|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611317|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611318|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611319|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611320|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611321|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611322|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611323|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611324|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611325|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611326|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611327|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611328|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611329|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
612305|NCT00490945|E2|Reported Event|10 mg VEC-162|Randomized to 10 mg VEC-162
611330|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611331|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611332|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611333|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611334|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611335|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611336|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611337|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611338|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611339|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611340|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611341|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611342|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611343|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611344|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611345|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611346|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611347|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611348|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611349|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611350|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611351|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611352|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611353|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611354|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611355|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611356|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611357|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611358|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611359|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611360|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611361|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611362|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611363|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611364|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611400|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611365|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611366|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611367|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611368|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611369|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611370|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611371|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611372|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611373|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611374|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611375|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611376|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611377|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611378|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611379|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611380|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611381|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611382|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611383|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611384|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611385|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611386|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611387|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611388|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611389|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611390|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611391|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611392|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611393|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611394|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611395|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611396|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611397|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611398|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611399|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611437|NCT00493285|E5|Reported Event|10^6 MEDI-534|
611401|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611402|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611403|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611404|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611405|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611406|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611407|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611408|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611409|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611410|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611411|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611412|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611413|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611414|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611415|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611416|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611417|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611418|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611419|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611420|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611421|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611422|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611423|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611424|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611425|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611426|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611427|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611428|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611429|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611430|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611431|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611432|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611433|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611434|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
611435|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
611436|NCT00493285|E6|Reported Event|10^6 PLACEBO|
611443|NCT00493246|B8|Baseline|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611444|NCT00493246|B7|Baseline|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611445|NCT00493246|B6|Baseline|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611446|NCT00493246|B5|Baseline|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611447|NCT00493246|B4|Baseline|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611448|NCT00493246|B3|Baseline|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611449|NCT00493246|B2|Baseline|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611450|NCT00493246|B1|Baseline|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611451|NCT00493246|P8|Participant Flow|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611452|NCT00493246|P7|Participant Flow|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611453|NCT00493246|P6|Participant Flow|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611454|NCT00493246|P5|Participant Flow|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611455|NCT00493246|P4|Participant Flow|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611456|NCT00493246|P3|Participant Flow|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611457|NCT00493246|P2|Participant Flow|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611458|NCT00493246|P1|Participant Flow|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611459|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611460|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611461|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611462|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611463|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611464|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611465|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611466|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611467|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611468|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611496|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611469|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611470|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611471|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611472|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611473|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611474|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611475|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611476|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611477|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611478|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611479|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611480|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611481|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611482|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611483|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611484|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611485|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611486|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611487|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611488|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611489|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611490|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611491|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611492|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611493|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611494|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611495|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611569|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611497|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611498|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611499|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611500|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611501|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611502|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611503|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611504|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611505|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611506|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611507|NCT00493246|E8|Reported Event|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611508|NCT00493246|E7|Reported Event|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611509|NCT00493246|E6|Reported Event|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611510|NCT00493246|E5|Reported Event|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611511|NCT00493246|E4|Reported Event|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611512|NCT00493246|E3|Reported Event|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
611513|NCT00493246|E2|Reported Event|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
611514|NCT00493246|E1|Reported Event|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
611515|NCT00493220|B7|Baseline|Total|Total of all reporting groups
611516|NCT00493220|B6|Baseline|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
611517|NCT00493220|B5|Baseline|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
611518|NCT00493220|B4|Baseline|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
611519|NCT00493220|B3|Baseline|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
611520|NCT00493220|B2|Baseline|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
611521|NCT00493220|B1|Baseline|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
611522|NCT00493220|P6|Participant Flow|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
611523|NCT00493220|P5|Participant Flow|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
611524|NCT00493220|P4|Participant Flow|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
611525|NCT00493220|P3|Participant Flow|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
612306|NCT00490945|E1|Reported Event|Placebo|Randomized to Placebo
611526|NCT00493220|P2|Participant Flow|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
611527|NCT00493220|P1|Participant Flow|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
611528|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
611529|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
611530|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
611531|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
611532|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
611533|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
611534|NCT00493220|O3|Outcome|Intravenous|All per-protocol participant administered intravenous ceftriaxone
611535|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
611536|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
611537|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
611538|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
611539|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous hylenex and ceftriaxone
611540|NCT00493220|E3|Reported Event|Intravenous|All participants administered intravenous ceftriaxone
611541|NCT00493220|E2|Reported Event|Placebo SC|All participants administered subcutaneous placebo and ceftriaxone
611542|NCT00493220|E1|Reported Event|HYLENEX SC|All participants administered subcutaneous HYLENEX and ceftriaxone
611543|NCT00493181|B1|Baseline|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
611544|NCT00493181|P1|Participant Flow|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
611545|NCT00493181|O1|Outcome|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
611546|NCT00493181|E1|Reported Event|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
611547|NCT00493038|B3|Baseline|Total|Total of all reporting groups
611548|NCT00493038|B2|Baseline|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611549|NCT00493038|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611550|NCT00493038|P2|Participant Flow|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611551|NCT00493038|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611552|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611553|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611554|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611555|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611556|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611557|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611558|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611559|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611560|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611561|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611562|NCT00493038|E2|Reported Event|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
611563|NCT00493038|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
611564|NCT00493012|B3|Baseline|Total|Total of all reporting groups
611565|NCT00493012|B2|Baseline|Placebo Comparator|A daily placebo oil is given for year
611566|NCT00493012|B1|Baseline|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611567|NCT00493012|P2|Participant Flow|Placebo Comparator|A daily placebo oil is given for year
611568|NCT00493012|P1|Participant Flow|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611570|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611571|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611572|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611573|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611574|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611575|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611576|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611577|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611578|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611579|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611580|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611581|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611582|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611583|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611584|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611585|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611586|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611587|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611588|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611589|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
611590|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611591|NCT00493012|E2|Reported Event|Placebo Comparator|A daily placebo oil is given for year
611592|NCT00493012|E1|Reported Event|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
611593|NCT00492973|B3|Baseline|Total|Total of all reporting groups
611594|NCT00492973|B2|Baseline|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611595|NCT00492973|B1|Baseline|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
611596|NCT00492973|P2|Participant Flow|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611597|NCT00492973|P1|Participant Flow|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
611598|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611599|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
611600|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611601|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
611602|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611603|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
611604|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611605|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
611606|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611607|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
612307|NCT00490919|B3|Baseline|Total|Total of all reporting groups
611608|NCT00492973|E2|Reported Event|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
611609|NCT00492973|E1|Reported Event|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
611610|NCT00492856|B1|Baseline|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
611611|NCT00492856|P4|Participant Flow|Post-consolidation Gemtuzumab Ozogamicin|Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does).
611612|NCT00492856|P3|Participant Flow|Post-consolidation Observation|Patients who achieved CRm after consolidation and were randomized to the observation arm.
611613|NCT00492856|P2|Participant Flow|Post-consolidation ATRA, 6-MP, MTX|Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
611614|NCT00492856|P1|Participant Flow|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
611615|NCT00492856|O2|Outcome|Post-consolidation Therapy Arm II|Patients receive no further chemotherapy. (Randomization and observation arm closed as of 05/27/10)
611616|NCT00492856|O1|Outcome|Post-consolidation Therapy Arm I|"Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.~mercaptopurine: Given orally~methotrexate: Given orally~tretinoin: Given orally"
611617|NCT00492856|O4|Outcome|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
611618|NCT00492856|O3|Outcome|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
611619|NCT00492856|O2|Outcome|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
611620|NCT00492856|O1|Outcome|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
611621|NCT00492856|E4|Reported Event|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
611622|NCT00492856|E3|Reported Event|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
611623|NCT00492856|E2|Reported Event|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
611624|NCT00492856|E1|Reported Event|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
611625|NCT00492752|B3|Baseline|Total|Total of all reporting groups
611626|NCT00492752|B2|Baseline|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611627|NCT00492752|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611628|NCT00492752|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Participants switched to Open-label Sorafenib treatment from Placebo after unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are the data reported in Reporting Group (RG) 3."
611629|NCT00492752|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Participants randomized to Sorafenib-matching Placebo until unblinding (August 19, 2007), Placebo tablets matching in appearance were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 2."
611630|NCT00492752|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|"Participants randomized to Sorafenib treatment from until unblinding (August 19, 2007) until end of trial (July 27, 2009), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
611631|NCT00492752|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|"Participants randomized to Sorafenib treatment until unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
611632|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611633|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611634|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611635|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611636|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611637|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611638|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611639|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611640|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611641|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611642|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611643|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611644|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611645|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611646|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611647|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611648|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611649|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611650|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611651|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611652|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611653|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611654|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611655|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611656|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611657|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611658|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
611734|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611659|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611660|NCT00492752|E3|Reported Event|Placebo, Open Label Only (Participants Switched to Sorafenib)|Reporting Group 3 (RG 3): Participants switched to Open-label Sorafenib treatment from Placebo ( Data after unblinding [August 19, 2007] until end of this trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611661|NCT00492752|E2|Reported Event|Placebo, All (Double-Blind and Open Label Phase)|Reporting Group 2 (RG 2): All participants randomized to Sorafenib-matching Placebo (data from start of treatment until end of trial [July 27, 2009]). Treatment for Double-Blind phase (before unblinding [August 19, 2007]): Placebo tablets matching in appearance were orally administered twice daily (bid); Treatment for Open Label phase (after unblinding [August 19, 2007]): Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611662|NCT00492752|E1|Reported Event|Sorafenib, All (Double-Blind and Open Label Phase)|Reporting Group 1 (RG 1): All participants randomized to Sorafenib treatment (data from start of treatment until end of trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
611663|NCT00492726|B3|Baseline|Total|Total of all reporting groups
611664|NCT00492726|B2|Baseline|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611665|NCT00492726|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611666|NCT00492726|P2|Participant Flow|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611667|NCT00492726|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611668|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611669|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611670|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611671|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611672|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611673|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611674|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611675|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611676|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611677|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611678|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611679|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611680|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611681|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611682|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611683|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611684|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611685|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611686|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611687|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611688|NCT00492726|E2|Reported Event|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
611689|NCT00492726|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
611690|NCT00492622|B1|Baseline|All Participants|
611691|NCT00492622|P1|Participant Flow|All Study Participants|All participants were randomized to receive all formulations so baseline measures are reported for all participants.
611692|NCT00492622|O2|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
611693|NCT00492622|O1|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
611694|NCT00492622|O2|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole concentration: Delayed-release omeprazole 40 mg qam for 7 days
611695|NCT00492622|O1|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole concentration: Immediate-release omeprazole 40 mg qam for 7 days
611696|NCT00492622|O2|Outcome|All Study Subjects Delayed Release Arm|Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
611697|NCT00492622|O1|Outcome|All Study Participants Immediate Release Arm|Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
611698|NCT00492622|E2|Reported Event|Delayed Release Omeprazole|"subjects receive delayed release for 7 days then immediate release for 7 days~Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days"
611699|NCT00492622|E1|Reported Event|Immediate Release Fomeprazole|"subjects received immediate release for 7 days then delayed release for 7 days~Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days"
611700|NCT00492583|B3|Baseline|Total|Total of all reporting groups
611701|NCT00492583|B2|Baseline|Bifidobacterium Lactis (BB-12)|
611702|NCT00492583|B1|Baseline|Placebo|
611703|NCT00492583|P2|Participant Flow|Bifidobacterium Lactis (BB-12)|
611704|NCT00492583|P1|Participant Flow|Placebo|
611705|NCT00492583|O2|Outcome|Bifidobacterium Lactis (BB-12)|
611706|NCT00492583|O1|Outcome|Placebo|
611707|NCT00492583|E2|Reported Event|Bifidobacterium Lactis (BB-12)|
611708|NCT00492583|E1|Reported Event|Placebo|
611709|NCT00492557|B3|Baseline|Total|Total of all reporting groups
611710|NCT00492557|B2|Baseline|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
611711|NCT00492557|B1|Baseline|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
611712|NCT00492557|P2|Participant Flow|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
611713|NCT00492557|P1|Participant Flow|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
611714|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
611715|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
611716|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
611717|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
611718|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
611719|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
611720|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
611721|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
611722|NCT00492557|O2|Outcome|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
611723|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
611724|NCT00492557|E4|Reported Event|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM [Placebo + TIV]).
611725|NCT00492557|E3|Reported Event|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
611726|NCT00492557|E2|Reported Event|Placebo|Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM [13vPnC + TIV]).
611727|NCT00492557|E1|Reported Event|13vPnC+TIV|Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.
611728|NCT00492544|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611729|NCT00492544|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611730|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611731|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611732|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611733|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611735|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611736|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611737|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611738|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611739|NCT00492544|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
611740|NCT00492531|B3|Baseline|Total|Total of all reporting groups
611741|NCT00492531|B2|Baseline|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611742|NCT00492531|B1|Baseline|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611743|NCT00492531|P2|Participant Flow|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611744|NCT00492531|P1|Participant Flow|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611745|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611746|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611747|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611748|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611749|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611750|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611751|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611752|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611753|NCT00492531|E2|Reported Event|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611754|NCT00492531|E1|Reported Event|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
611755|NCT00492401|B1|Baseline|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
611756|NCT00492401|P1|Participant Flow|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
611757|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
611758|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
611759|NCT00492401|O2|Outcome|Non Responder|Any patient that did not achieve a CR (Complete Response), or Incomplete CR was categorized as a non responder.
611760|NCT00492401|O1|Outcome|Responders|Any patient that achieved a CR (Complete Response), or Incomplete CR was categorized as a responder.
611761|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
611762|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
611763|NCT00492401|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~decitabine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~high performance liquid chromatography: Correlative studies~microarray analysis: Correlative studies~RNA analysis: Correlative studies~mass spectrometry: Correlative studies~DNA methylation analysis: Correlative studies~matrix-assisted laser desorption/ionization time of flight mass spectrometry: Correlative studies"
611764|NCT00492349|B3|Baseline|Total|Total of all reporting groups
611765|NCT00492349|B2|Baseline|Placebo|
611766|NCT00492349|B1|Baseline|Varenicline|
611767|NCT00492349|P2|Participant Flow|Placebo|Placebo Control Group
611768|NCT00492349|P1|Participant Flow|Varenicline|Varenicline Treatment Group
611769|NCT00492349|O2|Outcome|Placebo|Placebo
611770|NCT00492349|O1|Outcome|Varenicline|Varenicline
611771|NCT00492349|O2|Outcome|Placebo|"Placebo~Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks"
611772|NCT00492349|O1|Outcome|Varenicline|Varenicline
611773|NCT00492349|O2|Outcome|Placebo|Placebo
611774|NCT00492349|O1|Outcome|Varenicline|Varenicline
611775|NCT00492349|O2|Outcome|Placebo|"Placebo~Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks"
611776|NCT00492349|O1|Outcome|Varenicline|"Varenicline~Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks"
611777|NCT00492349|O2|Outcome|Placebo|Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
611778|NCT00492349|O1|Outcome|Varenicline|Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
611779|NCT00492349|O2|Outcome|Placebo|Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
611780|NCT00492349|O1|Outcome|Varenicline|Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
611781|NCT00492349|O2|Outcome|Placebo|Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
611782|NCT00492349|O1|Outcome|Varenicline|Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
611783|NCT00492349|O2|Outcome|Placebo|Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
611784|NCT00492349|O1|Outcome|Varenicline|Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
611785|NCT00492349|E2|Reported Event|Placebo|Placebo
611786|NCT00492349|E1|Reported Event|Varenicline|Varenicline
611787|NCT00492336|B3|Baseline|Total|Total of all reporting groups
611788|NCT00492336|B2|Baseline|Inactive Pill|Treatment with Placebo
611789|NCT00492336|B1|Baseline|Rasagiline|Treatment with Rasagiline
611790|NCT00492336|P2|Participant Flow|Inactive Pill|Treatment with Placebo
611791|NCT00492336|P1|Participant Flow|Rasagiline|Treatment with Rasagiline
611792|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611793|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611794|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611795|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611796|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611797|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611798|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611799|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611800|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611801|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611802|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611803|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611804|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611805|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611806|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611807|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611808|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611809|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611810|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611811|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611812|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
611813|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
611814|NCT00492336|E2|Reported Event|Inactive Pill|Treatment with Placebo
611815|NCT00492336|E1|Reported Event|Rasagiline|Treatment with Rasagiline
611816|NCT00492297|B1|Baseline|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611817|NCT00492297|P1|Participant Flow|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid), the treatment continued until subjects had clear palliative benefit and were tolerating treatment well, or until progressive disease (PD) or death (if earlier) recorded up to 97 weeks. Subjects withdrawn from Sorafenib but with optional standard treatment entered Active Follow-up (AFU) period, which was 30(+4) days for subjects who had PD at the end of treatment; or until PD was documented for subjects who had complete response (CR) or partial response (PR) or stable disease (SD) at the end of treatment up to 97 weeks . Once subject progressed went into survival only follow-up which continued until death occurred up to 172 weeks.
611818|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611819|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611820|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611821|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611822|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611823|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611824|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611825|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611826|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611827|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611828|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611829|NCT00492297|E1|Reported Event|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
611830|NCT00492284|B5|Baseline|Total|Total of all reporting groups
611831|NCT00492284|B4|Baseline|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611832|NCT00492284|B3|Baseline|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611833|NCT00492284|B2|Baseline|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611834|NCT00492284|B1|Baseline|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611835|NCT00492284|P4|Participant Flow|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611836|NCT00492284|P3|Participant Flow|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611837|NCT00492284|P2|Participant Flow|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611838|NCT00492284|P1|Participant Flow|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611839|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611840|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611841|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611842|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611843|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611844|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611845|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611846|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611847|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611848|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611849|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611850|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611851|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611852|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611853|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611854|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611855|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611856|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611857|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611858|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611859|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611860|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611901|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
620737|NCT00469079|O2|Outcome|Taboka|Taboka - oral tobacco product
611861|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611862|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611863|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611864|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611865|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611866|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611867|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611868|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611869|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611870|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611871|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611872|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611873|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611874|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611875|NCT00492284|E4|Reported Event|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
611876|NCT00492284|E3|Reported Event|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
611877|NCT00492284|E2|Reported Event|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611878|NCT00492284|E1|Reported Event|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
611879|NCT00492232|B3|Baseline|Total|Total of all reporting groups
611880|NCT00492232|B2|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611881|NCT00492232|B1|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611882|NCT00492232|P2|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611883|NCT00492232|P1|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611884|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611885|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611886|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611887|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611888|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611889|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611890|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611891|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611892|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611893|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611894|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611895|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611896|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611897|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611898|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611899|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611900|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611902|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611903|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611904|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611905|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611906|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611907|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611908|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611909|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611910|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611911|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611912|NCT00492232|E2|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
611913|NCT00492232|E1|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
611914|NCT00492206|B1|Baseline|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
611915|NCT00492206|P1|Participant Flow|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
611916|NCT00492206|O1|Outcome|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
611917|NCT00492206|O1|Outcome|Received Concurrent Radiotherapy + Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
611918|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
611919|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
611920|NCT00492206|E1|Reported Event|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
611921|NCT00492089|B3|Baseline|Total|Total of all reporting groups
611922|NCT00492089|B2|Baseline|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
611923|NCT00492089|B1|Baseline|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
611924|NCT00492089|P2|Participant Flow|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A.
611925|NCT00492089|P1|Participant Flow|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks.
611926|NCT00492089|O2|Outcome|Crossover Arm B: Placebo Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
611927|NCT00492089|O1|Outcome|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
611928|NCT00492089|E2|Reported Event|Placebo|First Intervention Placebo IV (only) every 3 weeks for two courses
611929|NCT00492089|E1|Reported Event|Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
611930|NCT00492063|B5|Baseline|Total|Total of all reporting groups
611931|NCT00492063|B4|Baseline|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611932|NCT00492063|B3|Baseline|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611933|NCT00492063|B2|Baseline|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611934|NCT00492063|B1|Baseline|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611935|NCT00492063|P4|Participant Flow|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
612337|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
611936|NCT00492063|P3|Participant Flow|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611937|NCT00492063|P2|Participant Flow|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611938|NCT00492063|P1|Participant Flow|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611939|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611940|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611941|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611942|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611943|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611944|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611945|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611946|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611947|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611948|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611949|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611950|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611951|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611952|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611953|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611954|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611955|NCT00492063|E4|Reported Event|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611956|NCT00492063|E3|Reported Event|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611957|NCT00492063|E2|Reported Event|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
611958|NCT00492063|E1|Reported Event|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
611959|NCT00492024|B3|Baseline|Total|Total of all reporting groups
611960|NCT00492024|B2|Baseline|Placebo|Matching placebo for 5 days
611961|NCT00492024|B1|Baseline|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611962|NCT00492024|P2|Participant Flow|Placebo|Matching placebo for 5 days
611963|NCT00492024|P1|Participant Flow|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611964|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
611965|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611966|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
611967|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611968|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
611969|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611970|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
611971|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611972|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
611973|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611974|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
611975|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611976|NCT00492024|E2|Reported Event|Placebo|Matching placebo for 5 days
611977|NCT00492024|E1|Reported Event|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
611978|NCT00491894|B1|Baseline|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
611979|NCT00491894|P1|Participant Flow|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
611980|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
611981|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
611982|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
611983|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
612338|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
611984|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
611985|NCT00491894|E1|Reported Event|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
611986|NCT00491829|B4|Baseline|Total|Total of all reporting groups
611987|NCT00491829|B3|Baseline|Placebo|"placebo qhs~placebo: placebo"
611988|NCT00491829|B2|Baseline|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
611989|NCT00491829|B1|Baseline|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
611990|NCT00491829|P3|Participant Flow|Placebo|"placebo qhs~placebo: placebo"
611991|NCT00491829|P2|Participant Flow|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
611992|NCT00491829|P1|Participant Flow|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
611993|NCT00491829|O3|Outcome|Placebo|"placebo qhs~placebo: placebo"
611994|NCT00491829|O2|Outcome|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
611995|NCT00491829|O1|Outcome|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
611996|NCT00491829|E3|Reported Event|Placebo|"placebo qhs~placebo: placebo"
611997|NCT00491829|E2|Reported Event|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
611998|NCT00491829|E1|Reported Event|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
611999|NCT00491764|B7|Baseline|Total|Total of all reporting groups
612000|NCT00491764|B6|Baseline|Placebo for 24 Weeks|Placebo for 24 weeks.
612001|NCT00491764|B5|Baseline|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
612002|NCT00491764|B4|Baseline|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
612003|NCT00491764|B3|Baseline|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
612004|NCT00491764|B2|Baseline|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
612005|NCT00491764|B1|Baseline|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
612006|NCT00491764|P6|Participant Flow|Placebo for 24 Weeks|Placebo for 24 weeks.
612007|NCT00491764|P5|Participant Flow|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
612008|NCT00491764|P4|Participant Flow|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
612009|NCT00491764|P3|Participant Flow|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
612010|NCT00491764|P2|Participant Flow|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
612011|NCT00491764|P1|Participant Flow|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
612012|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
612013|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
612014|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
612015|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
612016|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
612017|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
612018|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
612019|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
612020|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
612021|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
612022|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
612023|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
612024|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
612025|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
612026|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
612027|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
612028|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
612029|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
612030|NCT00491764|E6|Reported Event|Placebo for 24 Weeks|Placebo for 24 weeks
612031|NCT00491764|E5|Reported Event|Terbinafine 250 mg QD for 12 Weeks|Terbinafine 250 mg QD for 12 weeks
612032|NCT00491764|E4|Reported Event|Posaconazole 400 mg QD for 12 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks
612033|NCT00491764|E3|Reported Event|Posaconazole 400 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks
612034|NCT00491764|E2|Reported Event|Posaconazole 200 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks
612035|NCT00491764|E1|Reported Event|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks
612036|NCT00491738|B3|Baseline|Total|Total of all reporting groups
612037|NCT00491738|B2|Baseline|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
612038|NCT00491738|B1|Baseline|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
612827|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612039|NCT00491738|P2|Participant Flow|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
612040|NCT00491738|P1|Participant Flow|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
612041|NCT00491738|O2|Outcome|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
612042|NCT00491738|O1|Outcome|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
612043|NCT00491608|B1|Baseline|rThrombin|Participants who received at least 1 application of rThrombin during spinal or vascular surgery (arterial reconstruction or PAB,or AV vascular access procedure and had seronegative baseline rThrombin antibody status
612044|NCT00491608|P1|Participant Flow|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612045|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612046|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612047|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612048|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612049|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612050|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612051|NCT00491608|E1|Reported Event|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
612052|NCT00491556|B3|Baseline|Total|Total of all reporting groups
612053|NCT00491556|B2|Baseline|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
612054|NCT00491556|B1|Baseline|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612055|NCT00491556|P2|Participant Flow|Standard Care (STAND)|Began HAART with ATV/r under the current DHHS guidelines (CD4+ T cells below 350 cells/mm3 or for other clinical concerns as outlined in the recommendations and as determined by the site clinician).
612056|NCT00491556|P1|Participant Flow|Experimental-Early Initiation of HAART (EXP)|Began HAART consisting of TDF/FTC/ATV/r (preferred regimen), AZT/3TC/ATV/r, or other recommended NRTI HAART backbone with ATV/r upon entry to study. Subjects who achieved virologic control by week 24 (viral load (VL) < 100 copies/ml) and maintained good control through 48 weeks then entered deintensification (de-int) to ATV/r alone and were followed for two years.
612057|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612114|NCT00491530|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612058|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612059|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612060|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612061|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612062|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612063|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612064|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612065|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612066|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612189|NCT00491322|E1|Reported Event|Ergocalciferol Group|Ergocalciferol 50,000 international units once a week for 12 weeks
612190|NCT00491244|B3|Baseline|Total|Total of all reporting groups
612067|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612068|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612069|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612070|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612071|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612072|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612073|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612074|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612075|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612191|NCT00491244|B2|Baseline|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612076|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612077|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612078|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612079|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612080|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612081|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612082|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612083|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612084|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612979|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
612085|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612086|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612087|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612088|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612089|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612090|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612091|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612092|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612110|NCT00491556|E1|Reported Event|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612093|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612094|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612095|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612096|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612097|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612098|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612099|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612100|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612111|NCT00491530|B4|Baseline|Total|Total of all reporting groups
612112|NCT00491530|B3|Baseline|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612113|NCT00491530|B2|Baseline|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612101|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612102|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612103|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612104|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612105|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612106|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612107|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612108|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
612109|NCT00491556|E2|Reported Event|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
612115|NCT00491530|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612116|NCT00491530|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612117|NCT00491530|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612118|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612119|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612120|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612121|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612122|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612123|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612124|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612125|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612126|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612127|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612128|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612129|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612130|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612131|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612132|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612133|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612134|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612135|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612136|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612192|NCT00491244|B1|Baseline|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612137|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612138|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612139|NCT00491530|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612140|NCT00491530|E2|Reported Event|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612141|NCT00491530|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
612142|NCT00491504|B5|Baseline|Total|Total of all reporting groups
612143|NCT00491504|B4|Baseline|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
612144|NCT00491504|B3|Baseline|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
612145|NCT00491504|B2|Baseline|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
612146|NCT00491504|B1|Baseline|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
612147|NCT00491504|P4|Participant Flow|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
612148|NCT00491504|P3|Participant Flow|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
612149|NCT00491504|P2|Participant Flow|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
612150|NCT00491504|P1|Participant Flow|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
612151|NCT00491504|O2|Outcome|Placebo|All subjects who received 2 sprays each nostril of placebo on Day 1
612152|NCT00491504|O1|Outcome|Mometasone Furoate Nasal Spray 200 mcg|All subjects who received 2 sprays each nostril (total 200 mcg) of Mometasone Furoate Nasal Spray (MFNS) on Day 1
612153|NCT00491504|E4|Reported Event|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
612154|NCT00491504|E3|Reported Event|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
612155|NCT00491504|E2|Reported Event|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
612156|NCT00491504|E1|Reported Event|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
612157|NCT00491400|B3|Baseline|Total|Total of all reporting groups
612158|NCT00491400|B2|Baseline|Atorvastatin First|Atorvastatin First and Fenofibrate Second
612159|NCT00491400|B1|Baseline|Fenofibrate First|Fenofibrate First and Atorvastatin Second
612160|NCT00491400|P2|Participant Flow|Atorvastatin First|Participants randomized to receive atorvastatin first and fenofibrate second
612161|NCT00491400|P1|Participant Flow|Fenofibrate First|Participants randomized to receive fenofibrate first and atorvastatin second
612162|NCT00491400|O2|Outcome|Atorvastatin|Effect of atorvastatin treatment on lipid profile
612163|NCT00491400|O1|Outcome|Fenofibrate|Effect of fenofibrate treatment on lipid profile
612164|NCT00491400|O2|Outcome|Atorvastatin Treatment|Effect of atorvastatin on brachial artery FMD
612165|NCT00491400|O1|Outcome|Fenofibrate Treatment|Effect of fenofibrate on brachial artery FMD
612166|NCT00491400|E2|Reported Event|Atorvastatin First|Atorvastatin First and Fenofibrate Second
612167|NCT00491400|E1|Reported Event|Fenofibrate First|Fenofibrate First and Atorvastatin Second
612168|NCT00491387|B1|Baseline|Metoprolol Succinate|will receive I-123 MIBG innervation imaging before and after metoprolol succinate
612169|NCT00491387|P1|Participant Flow|Group 1|Treated with metoprolol succinate
612170|NCT00491387|O1|Outcome|Metoprolol Succinate|"Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.~Metoprolol Succinate: Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute."
612171|NCT00491387|E1|Reported Event|Metoprolol Succinate|Patients receive I-123 MIBG imaging before and after metoprolol succinate.
612172|NCT00491374|B3|Baseline|Total|Total of all reporting groups
612173|NCT00491374|B2|Baseline|Mometasone Furoate Nasal Spray|
612174|NCT00491374|B1|Baseline|Placebo|
612175|NCT00491374|P2|Participant Flow|Mometasone Furoate Nasal Spray|
612176|NCT00491374|P1|Participant Flow|Placebo|
612177|NCT00491374|O2|Outcome|Mometasone Furoate Nasal Spray|
612178|NCT00491374|O1|Outcome|Placebo|
612179|NCT00491374|E2|Reported Event|Mometasone Furoate Nasal Spray|
612180|NCT00491374|E1|Reported Event|Placebo|
612181|NCT00491322|B3|Baseline|Total|Total of all reporting groups
612182|NCT00491322|B2|Baseline|Placebo Group|Matching placebo once a week for 12 weeks
612183|NCT00491322|B1|Baseline|Ergocalciferol Group|Ergocalciferol 50000 international units once a week for 12 weeks
612184|NCT00491322|P2|Participant Flow|Placebo Group|Matching placebo once a week for 12 weeks
612185|NCT00491322|P1|Participant Flow|Ergocalciferol Group|Ergocalciferol 50000 international units once a week for 12 weeks
612186|NCT00491322|O2|Outcome|Ergocalciferol Placebo Group|Participants receiving matching ergocalciferol placebo weekly for 12 weeks
612187|NCT00491322|O1|Outcome|Ergocalciferol Group|Participants receiving ergocalciferol 50000 units weekly for 12 weeks
612188|NCT00491322|E2|Reported Event|Placebo Group|Matching placebo once a week for 12 weeks
612193|NCT00491244|P2|Participant Flow|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612194|NCT00491244|P1|Participant Flow|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612195|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612196|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612197|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612198|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612199|NCT00491244|E2|Reported Event|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612200|NCT00491244|E1|Reported Event|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
612201|NCT00491179|B3|Baseline|Total|Total of all reporting groups
612202|NCT00491179|B2|Baseline|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
612203|NCT00491179|B1|Baseline|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
612204|NCT00491179|P2|Participant Flow|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
612205|NCT00491179|P1|Participant Flow|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
612206|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
612207|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
612208|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
612209|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
612210|NCT00491179|E2|Reported Event|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
612211|NCT00491179|E1|Reported Event|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
612212|NCT00491075|B1|Baseline|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
612213|NCT00491075|P1|Participant Flow|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
612214|NCT00491075|O1|Outcome|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
612215|NCT00491075|E1|Reported Event|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
612216|NCT00490971|B3|Baseline|Total|Total of all reporting groups
612217|NCT00490971|B2|Baseline|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612218|NCT00490971|B1|Baseline|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612219|NCT00490971|P5|Participant Flow|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612220|NCT00490971|P4|Participant Flow|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612221|NCT00490971|P3|Participant Flow|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612222|NCT00490971|P2|Participant Flow|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612223|NCT00490971|P1|Participant Flow|Paliperidone Extented Release (ER)|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612224|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612225|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612226|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612227|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612228|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612229|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612230|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612231|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612232|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612233|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612234|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612235|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612236|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612237|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612238|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612239|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612240|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612241|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612242|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612243|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612244|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612245|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612246|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612247|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612248|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612249|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612250|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612251|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612252|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612253|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612254|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612255|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612256|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612257|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612258|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612259|NCT00490971|E5|Reported Event|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
612260|NCT00490971|E4|Reported Event|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
612261|NCT00490971|E3|Reported Event|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
612262|NCT00490971|E2|Reported Event|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
612263|NCT00490971|E1|Reported Event|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
612264|NCT00490945|B6|Baseline|Total|Total of all reporting groups
612265|NCT00490945|B5|Baseline|100 mg VEC-162|Randomized to 100 mg VEC-162
612266|NCT00490945|B4|Baseline|50 mg VEC-162|Randomized to 50 mg VEC-162
612267|NCT00490945|B3|Baseline|20 mg VEC-162|Randomized to 20 mg VEC-162
612268|NCT00490945|B2|Baseline|10 mg VEC-162|Randomized to 10 mg VEC-162
612269|NCT00490945|B1|Baseline|Placebo|Randomized to Placebo
612270|NCT00490945|P5|Participant Flow|100 mg VEC-162|Randomized to 100 mg VEC-162
612271|NCT00490945|P4|Participant Flow|50 mg VEC-162|Randomized to 50 mg VEC-162
612272|NCT00490945|P3|Participant Flow|20 mg VEC-162|Randomized to 20 mg VEC-162
612273|NCT00490945|P2|Participant Flow|10 mg VEC-162|Randomized to 10 mg VEC-162
612274|NCT00490945|P1|Participant Flow|Placebo|Randomized to Placebo
612275|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
612276|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
612277|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
612278|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
612279|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
612280|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
612281|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
612282|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
612283|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
612284|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
612285|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
612308|NCT00490919|B2|Baseline|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612309|NCT00490919|B1|Baseline|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612310|NCT00490919|P3|Participant Flow|Double-blind Placebo TDS|Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
612311|NCT00490919|P2|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
612312|NCT00490919|P1|Participant Flow|Open-label Run-in Period|"The open-label run-in period (< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).~Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population."
612313|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612314|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612315|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612316|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612317|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612318|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
612319|NCT00490919|E3|Reported Event|Open-label Run-in Period, BTDS 5, 10, 20|Open-label BTDS 5, 10, 20 applied for 7-day wear
612320|NCT00490919|E2|Reported Event|Double-blind Placebo TDS 10, 20|Matching placebo TDS 10 or 20 applied for 7-day wear
612321|NCT00490919|E1|Reported Event|Double-blind BTDS 10, 20|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear
612322|NCT00490841|B1|Baseline|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612323|NCT00490841|P1|Participant Flow|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612324|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612325|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612326|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612327|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612328|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612329|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612330|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612331|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612332|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612333|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612334|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612335|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612336|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
612339|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612340|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612341|NCT00490841|E1|Reported Event|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
612342|NCT00490815|B3|Baseline|Total|Total of all reporting groups
612343|NCT00490815|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
612344|NCT00490815|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
612345|NCT00490815|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant administered in one eye
612346|NCT00490815|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant administered in one eye
612347|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
612348|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
612349|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
612350|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
612351|NCT00490815|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
612352|NCT00490815|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
612353|NCT00490802|B3|Baseline|Total|Total of all reporting groups
612354|NCT00490802|B2|Baseline|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
612355|NCT00490802|B1|Baseline|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612356|NCT00490802|P2|Participant Flow|Placebo|Placebo Comparator : Placebo Comparator
612357|NCT00490802|P1|Participant Flow|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612358|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
612359|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612360|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
612361|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612362|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
612363|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612364|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
612365|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612366|NCT00490802|O2|Outcome|Placebo|Placebo Comparator : Placebo Comparator
612367|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612368|NCT00490802|E2|Reported Event|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
612369|NCT00490802|E1|Reported Event|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
612370|NCT00490724|B4|Baseline|Total|Total of all reporting groups
612371|NCT00490724|B3|Baseline|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612372|NCT00490724|B2|Baseline|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612373|NCT00490724|B1|Baseline|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612374|NCT00490724|P3|Participant Flow|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612375|NCT00490724|P2|Participant Flow|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612376|NCT00490724|P1|Participant Flow|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612377|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612456|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612378|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612379|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612380|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612381|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612382|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612383|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612384|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612385|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612386|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612387|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612388|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612389|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612390|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612391|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612392|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612393|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612394|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612395|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612396|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612397|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612398|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612399|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612400|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612401|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612402|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612403|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612404|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612405|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612406|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612407|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612408|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612409|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612410|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612411|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612412|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612413|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612414|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612415|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612416|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612417|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612418|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612419|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612420|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612421|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612422|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612423|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612424|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612425|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612426|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612427|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612428|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612429|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612430|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612431|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612432|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612433|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612434|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612435|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612436|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612437|NCT00490724|E3|Reported Event|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
612438|NCT00490724|E2|Reported Event|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
612439|NCT00490724|E1|Reported Event|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
612440|NCT00490698|B1|Baseline|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
612441|NCT00490698|P1|Participant Flow|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
612442|NCT00490698|O1|Outcome|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
612443|NCT00490698|E1|Reported Event|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
612444|NCT00490646|B3|Baseline|Total|Total of all reporting groups
612445|NCT00490646|B2|Baseline|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612446|NCT00490646|B1|Baseline|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612447|NCT00490646|P2|Participant Flow|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612448|NCT00490646|P1|Participant Flow|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612449|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612450|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612451|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612452|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612453|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612454|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612455|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612519|NCT00490555|E1|Reported Event|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
612520|NCT00490542|B3|Baseline|Total|Total of all reporting groups
612457|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612458|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612459|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612460|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612461|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612462|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612463|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612464|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612465|NCT00490646|E2|Reported Event|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612466|NCT00490646|E1|Reported Event|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
612467|NCT00490568|B1|Baseline|RSG XR (AVA102675)|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612468|NCT00490568|P1|Participant Flow|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of Acetylcholinesterase Inhibitor (AChEI) for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received oral 4 milligram (mg) once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612469|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612470|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612471|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612472|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612690|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612473|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612474|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612475|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612476|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612477|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612478|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612479|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612480|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612481|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612482|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR..
621598|NCT00467844|P1|Participant Flow|GTx -024|1 mg
612483|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612484|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612485|NCT00490568|O1|Outcome|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR..
612486|NCT00490568|E1|Reported Event|RSG XR|Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer’s disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.
612487|NCT00490555|B5|Baseline|Total|Total of all reporting groups
612488|NCT00490555|B4|Baseline|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
612489|NCT00490555|B3|Baseline|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612490|NCT00490555|B2|Baseline|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
612491|NCT00490555|B1|Baseline|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
612492|NCT00490555|P4|Participant Flow|4) T Gel+DMPA|Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
612493|NCT00490555|P3|Participant Flow|3) T Gel+Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612494|NCT00490555|P2|Participant Flow|2) Testosterone (T) Gel|Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA
612495|NCT00490555|P1|Participant Flow|1) Placebo|Placebo gel + Placebo pill + placebo DMPA
612496|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
612497|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612498|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
612499|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
612500|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
612501|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612502|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
612503|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
612504|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
612505|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612506|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
612507|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
612508|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
612509|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612510|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
612511|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
612512|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
612513|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612514|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
612515|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
612516|NCT00490555|E4|Reported Event|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
612517|NCT00490555|E3|Reported Event|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
612518|NCT00490555|E2|Reported Event|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
621599|NCT00467844|O3|Outcome|3 mg of Placebo|Placebo
612521|NCT00490542|B2|Baseline|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
612522|NCT00490542|B1|Baseline|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
612523|NCT00490542|P2|Participant Flow|Double-blind Flexible-dose Ziprasidone Arm|Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.
612524|NCT00490542|P1|Participant Flow|Double-blind Flexible-dose Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
612525|NCT00490542|O2|Outcome|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
612526|NCT00490542|O1|Outcome|Ziprasidone Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
612527|NCT00490542|E2|Reported Event|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
612528|NCT00490542|E1|Reported Event|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
612529|NCT00490490|B1|Baseline|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
612530|NCT00490490|P1|Participant Flow|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
612531|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
612532|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
612533|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
612534|NCT00490490|E1|Reported Event|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
612535|NCT00490477|B3|Baseline|Total|Total of all reporting groups
612536|NCT00490477|B2|Baseline|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
612537|NCT00490477|B1|Baseline|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
612538|NCT00490477|P2|Participant Flow|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
612539|NCT00490477|P1|Participant Flow|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
612540|NCT00490477|O2|Outcome|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
612541|NCT00490477|O1|Outcome|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
612542|NCT00490477|E2|Reported Event|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
612543|NCT00490477|E1|Reported Event|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
612544|NCT00490451|B3|Baseline|Total|Total of all reporting groups
612545|NCT00490451|B2|Baseline|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612546|NCT00490451|B1|Baseline|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612547|NCT00490451|P2|Participant Flow|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612548|NCT00490451|P1|Participant Flow|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612549|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612550|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612691|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612692|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612551|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612552|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612553|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612554|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612555|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612556|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612557|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612558|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612559|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612560|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612561|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612562|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612563|NCT00490451|O2|Outcome|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612564|NCT00490451|O1|Outcome|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612565|NCT00490451|E2|Reported Event|LY573636 Target Cmax 360 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 360 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612566|NCT00490451|E1|Reported Event|LY573636 Target Cmax 420 µg/mL|LY573636 dose is dependent on participant's height, weight, and gender to target maximum concentration (Cmax) of 420 micrograms/milliliter (µg/mL) and is administered intravenously every 21- or 28-day cycle until disease progression or other criteria for participant discontinuation are met.
612567|NCT00490269|B3|Baseline|Total|Total of all reporting groups
612568|NCT00490269|B2|Baseline|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612569|NCT00490269|B1|Baseline|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612570|NCT00490269|P2|Participant Flow|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612571|NCT00490269|P1|Participant Flow|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612693|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612572|NCT00490269|O2|Outcome|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612573|NCT00490269|O1|Outcome|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612574|NCT00490269|E2|Reported Event|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612575|NCT00490269|E1|Reported Event|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
612576|NCT00490256|B3|Baseline|Total|Total of all reporting groups
612577|NCT00490256|B2|Baseline|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
612578|NCT00490256|B1|Baseline|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
612579|NCT00490256|P2|Participant Flow|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
612580|NCT00490256|P1|Participant Flow|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
612581|NCT00490256|O2|Outcome|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
612582|NCT00490256|O1|Outcome|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
612583|NCT00490256|E2|Reported Event|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
612584|NCT00490256|E1|Reported Event|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
612585|NCT00490139|B5|Baseline|Total|Total of all reporting groups
612586|NCT00490139|B4|Baseline|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612587|NCT00490139|B3|Baseline|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612588|NCT00490139|B2|Baseline|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612589|NCT00490139|B1|Baseline|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612590|NCT00490139|P4|Participant Flow|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612694|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612591|NCT00490139|P3|Participant Flow|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612592|NCT00490139|P2|Participant Flow|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612593|NCT00490139|P1|Participant Flow|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612594|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612595|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612596|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612597|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612598|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612628|NCT00490061|P1|Participant Flow|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
612695|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612696|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612599|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612600|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612601|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612602|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612603|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612604|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612605|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612606|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612629|NCT00490061|O1|Outcome|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
612697|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612607|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612608|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612609|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612610|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612611|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612612|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612613|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612614|NCT00490139|O4|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612630|NCT00490061|O1|Outcome|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
621600|NCT00467844|O2|Outcome|GTx-024|3 mg
612615|NCT00490139|O3|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612616|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612617|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612618|NCT00490139|E4|Reported Event|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612619|NCT00490139|E3|Reported Event|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612620|NCT00490139|E2|Reported Event|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612621|NCT00490139|E1|Reported Event|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
612622|NCT00490100|B1|Baseline|Treatment|
612623|NCT00490100|P1|Participant Flow|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
612624|NCT00490100|O1|Outcome|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
612625|NCT00490100|O1|Outcome|Treatment|"XSCID patients with growth failre treated with Increlex, recombinant human IGF-1.~Increlex"
612626|NCT00490100|E1|Reported Event|Treatment|
612627|NCT00490061|B1|Baseline|Radiotherapy (Radiation) and Lapatinib|"1500mg/d once daily oral lapatinib administration plus Intensity Modulated Radio Therapy (IMRT) delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.~Lapatinib: 1500 mg po daily orally~Radiotherapy (radiation): Standard of Care~G.E. Healthcare 1.5T MR, systems revision 12.0 M5: Standard of Care, used to deliver IMRT~PET/CT: A subset of patients received imaging before and after treatment."
612631|NCT00490061|E1|Reported Event|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
612632|NCT00490035|B5|Baseline|Total Title|
612633|NCT00490035|B4|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612634|NCT00490035|B3|Baseline|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612635|NCT00490035|B2|Baseline|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612636|NCT00490035|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
612637|NCT00490035|P4|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612638|NCT00490035|P3|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612639|NCT00490035|P2|Participant Flow|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612640|NCT00490035|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
612641|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612642|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612643|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612644|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612645|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612646|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612647|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612648|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612649|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612650|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612651|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612652|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612653|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612654|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612655|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612656|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612657|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612658|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612659|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612660|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612661|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612662|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612663|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612664|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612665|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612666|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612667|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612668|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612669|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612670|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612671|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612672|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612673|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612674|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612675|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612676|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612677|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612678|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612679|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612680|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612681|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612682|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612683|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612684|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612685|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612686|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612687|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612688|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612689|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612698|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612699|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612700|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612701|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612702|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612703|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612704|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612705|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612706|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612707|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612708|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612709|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612710|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612711|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612712|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612713|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612714|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612715|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612716|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612717|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612718|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612719|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612720|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612721|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612722|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612723|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612724|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612725|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612726|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612727|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612728|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612729|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612730|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612731|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612732|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
612733|NCT00490035|E4|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
612734|NCT00490035|E3|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
612735|NCT00490035|E2|Reported Event|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
612736|NCT00490035|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
612737|NCT00490022|B3|Baseline|Total|Total of all reporting groups
612738|NCT00490022|B2|Baseline|DHT Gel|DHT gel (70 mg/day) for one month
612739|NCT00490022|B1|Baseline|Placebo DHT Gel|Placebo gel for one month
612740|NCT00490022|P2|Participant Flow|DHT Gel|DHT gel (70 mg/day) for one month
612741|NCT00490022|P1|Participant Flow|Placebo DHT Gel|Placebo gel for one month
612742|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
612743|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
612744|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
612745|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
612746|NCT00490022|E2|Reported Event|DHT Gel|DHT gel (70 mg/day) for one month
612747|NCT00490022|E1|Reported Event|Placebo DHT Gel|Placebo gel for one month
612748|NCT00490009|B1|Baseline|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
612749|NCT00490009|P1|Participant Flow|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
612750|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
612751|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
612752|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
612753|NCT00490009|E1|Reported Event|Bexxar + Tylenol + Benadryl + SSKI|Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV
612754|NCT00489970|B3|Baseline|Total|Total of all reporting groups
612755|NCT00489970|B2|Baseline|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612756|NCT00489970|B1|Baseline|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612757|NCT00489970|P2|Participant Flow|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612758|NCT00489970|P1|Participant Flow|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612759|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612760|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612761|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612762|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612763|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612764|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612765|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612766|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612767|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612768|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612769|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612770|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612771|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612772|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612773|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612774|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612775|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612776|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612777|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612778|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612779|NCT00489970|E2|Reported Event|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
612780|NCT00489970|E1|Reported Event|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
612781|NCT00489866|B3|Baseline|Total|Total of all reporting groups
612782|NCT00489866|B2|Baseline|Placebo|Identical to Aripiprazole
612783|NCT00489866|B1|Baseline|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
612784|NCT00489866|P2|Participant Flow|Placebo|Identical to Aripiprazole
612785|NCT00489866|P1|Participant Flow|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
612786|NCT00489866|O2|Outcome|Depression Symptoms Placebo Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
612787|NCT00489866|O1|Outcome|Depression Symptoms Aripiprazole Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
612788|NCT00489866|O2|Outcome|Resilience Symptoms PlaceboTreated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
612789|NCT00489866|O1|Outcome|Resilience Symptoms Aripiprazole Treated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
612790|NCT00489866|O2|Outcome|Psychotic Symptoms Placebo Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
612791|NCT00489866|O1|Outcome|Psychotic Symptoms Aripiprazole Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
612792|NCT00489866|O2|Outcome|Cognitive Symptoms PlaceboTreated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
612793|NCT00489866|O1|Outcome|Cognitive Symptoms Aripiprazole Treated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
612794|NCT00489866|O2|Outcome|PTSD Symptoms Placebo Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
612795|NCT00489866|O1|Outcome|PTSD Symptoms Aripiprazole Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
612796|NCT00489866|E2|Reported Event|Placebo|Identical to Aripiprazole
612797|NCT00489866|E1|Reported Event|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
612798|NCT00489853|B1|Baseline|Entire Study Population|Cross over study with 3 Arms. (1)Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily. (2)Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily. (3) Placebo, 1 inhalation twice daily
612799|NCT00489853|P3|Participant Flow|Placebo Then Formoterol Then Symbicort|Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612800|NCT00489853|P2|Participant Flow|Formoterol Then Symbicort Then Placebo|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
612801|NCT00489853|P1|Participant Flow|Symbicort Then Formoterol Then Placebo|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
612802|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612803|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612804|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612805|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612806|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612807|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612808|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612809|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612810|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612811|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612812|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612813|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612814|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612815|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612816|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612817|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612818|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612819|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612820|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612821|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612822|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612823|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612824|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612825|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612828|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612829|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612830|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612831|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612832|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612833|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612834|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612835|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612836|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612837|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612838|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612839|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612840|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612841|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612842|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612843|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612844|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612845|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612846|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612847|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612848|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612849|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612850|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612851|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612852|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612853|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612854|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612855|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612856|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612857|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612858|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612859|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612860|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612861|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612862|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612863|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612864|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612865|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612866|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612867|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612868|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612869|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612870|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612871|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612872|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612873|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612874|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612875|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612876|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612877|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612878|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612879|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612880|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612881|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612882|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612883|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612884|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612885|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612886|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612887|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612888|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612889|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
612890|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612891|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612892|NCT00489853|E3|Reported Event|Placebo|Placebo, 1 inhalation twice daily
612893|NCT00489853|E2|Reported Event|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
612894|NCT00489853|E1|Reported Event|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
612895|NCT00489736|B3|Baseline|Total|Total of all reporting groups
612896|NCT00489736|B2|Baseline|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
612897|NCT00489736|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
612898|NCT00489736|P2|Participant Flow|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
612899|NCT00489736|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
612900|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
612901|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
612902|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
612903|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
612904|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
612905|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
612906|NCT00489736|E2|Reported Event|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
612907|NCT00489736|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
612908|NCT00489554|B1|Baseline|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612909|NCT00489554|P1|Participant Flow|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612910|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612911|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612912|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612913|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612914|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612915|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612916|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612917|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612918|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612919|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612920|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612921|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612922|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612923|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612924|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612925|NCT00489554|E1|Reported Event|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
612926|NCT00489541|B3|Baseline|Total|Total of all reporting groups
612927|NCT00489541|B2|Baseline|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
612928|NCT00489541|B1|Baseline|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
612929|NCT00489541|P2|Participant Flow|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
612930|NCT00489541|P1|Participant Flow|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
612931|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
612932|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
612933|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
612934|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
612935|NCT00489541|E2|Reported Event|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
612936|NCT00489541|E1|Reported Event|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
612937|NCT00489489|B4|Baseline|Total|Total of all reporting groups
612938|NCT00489489|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612939|NCT00489489|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612940|NCT00489489|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612941|NCT00489489|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612942|NCT00489489|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612943|NCT00489489|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612944|NCT00489489|O2|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
612945|NCT00489489|O1|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
612946|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612947|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612948|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612949|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612950|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612951|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612952|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612953|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612954|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612955|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612956|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612957|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612958|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612959|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612960|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612961|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612962|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612963|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612964|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612965|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612966|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
612967|NCT00489489|E3|Reported Event|Teriflunomide 14 mg + + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
612968|NCT00489489|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
612969|NCT00489489|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with IFN-β for 24 weeks
612970|NCT00489476|B5|Baseline|Total|Total of all reporting groups
612971|NCT00489476|B4|Baseline|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
612972|NCT00489476|B3|Baseline|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
612973|NCT00489476|B2|Baseline|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
612974|NCT00489476|B1|Baseline|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
612975|NCT00489476|P4|Participant Flow|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
612976|NCT00489476|P3|Participant Flow|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
612977|NCT00489476|P2|Participant Flow|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
612978|NCT00489476|P1|Participant Flow|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
612980|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
612981|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
612982|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
612983|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
612984|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
612985|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
612986|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
612987|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
612988|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
612989|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
612990|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
612991|NCT00489476|E4|Reported Event|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
612992|NCT00489476|E3|Reported Event|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
612993|NCT00489476|E2|Reported Event|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
612994|NCT00489476|E1|Reported Event|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
612995|NCT00489424|B4|Baseline|Total|Total of all reporting groups
612996|NCT00489424|B3|Baseline|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
612997|NCT00489424|B2|Baseline|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
612998|NCT00489424|B1|Baseline|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
612999|NCT00489424|P3|Participant Flow|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613000|NCT00489424|P2|Participant Flow|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613001|NCT00489424|P1|Participant Flow|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613002|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613003|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613004|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613005|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613006|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613007|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613008|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613211|NCT00488774|E2|Reported Event|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
621601|NCT00467844|O1|Outcome|GTx -024|1 mg
613009|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613010|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613011|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613012|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613013|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613014|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613015|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613016|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613017|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613018|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613019|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613020|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613021|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613022|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613023|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613024|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613025|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613026|NCT00489424|E3|Reported Event|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613212|NCT00488774|E1|Reported Event|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
613027|NCT00489424|E2|Reported Event|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613028|NCT00489424|E1|Reported Event|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
613029|NCT00489411|B3|Baseline|Total|Total of all reporting groups
613030|NCT00489411|B2|Baseline|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613031|NCT00489411|B1|Baseline|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613032|NCT00489411|P2|Participant Flow|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613033|NCT00489411|P1|Participant Flow|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613034|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613035|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613036|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613037|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613038|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613159|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613039|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613040|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613041|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613042|NCT00489411|E2|Reported Event|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613043|NCT00489411|E1|Reported Event|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
613044|NCT00489359|B3|Baseline|Total|Total of all reporting groups
613045|NCT00489359|B2|Baseline|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613046|NCT00489359|B1|Baseline|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
613047|NCT00489359|P2|Participant Flow|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613048|NCT00489359|P1|Participant Flow|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
613049|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613050|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613051|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613052|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613160|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613053|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613054|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613055|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613056|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
613057|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
613058|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
613059|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
613060|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
613061|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613062|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
613063|NCT00489359|E7|Reported Event|Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)|"Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
613064|NCT00489359|E6|Reported Event|Pemetrexed 900 + Carboplatin AUC 6 (Phase 1)|"Pemetrexed (900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
613065|NCT00489359|E5|Reported Event|Pemetrexed 800 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (800 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613066|NCT00489359|E4|Reported Event|Pemetrexed 700 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (700 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613067|NCT00489359|E3|Reported Event|Pemetrexed 600 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613161|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613068|NCT00489359|E2|Reported Event|Pemetrexed 600 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613069|NCT00489359|E1|Reported Event|Pemetrexed 500 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
613070|NCT00489268|B6|Baseline|Total|Total of all reporting groups
613071|NCT00489268|B5|Baseline|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
613072|NCT00489268|B4|Baseline|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
613073|NCT00489268|B3|Baseline|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
613074|NCT00489268|B2|Baseline|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
613075|NCT00489268|B1|Baseline|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
613076|NCT00489268|P5|Participant Flow|Phase II|In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
613077|NCT00489268|P4|Participant Flow|Phase I: 12 J/cm^2|In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
613078|NCT00489268|P3|Participant Flow|Phase I: 10 J/cm^2|In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
613079|NCT00489268|P2|Participant Flow|Phase I: 8 J/cm^2|In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
613080|NCT00489268|P1|Participant Flow|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic Intestinal Metaplasia (IM), Low-Grade Dysplasia (LGD) and High-Grade Dysplasia (HGD). The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
613202|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0
613203|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
613081|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
613082|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
613083|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
613084|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
613085|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
613086|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
613087|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
613088|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
613204|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
613205|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
613089|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
613090|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
613091|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
613092|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
613093|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
613094|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
613095|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
613096|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
613206|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
613207|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
613097|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
613098|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
613099|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
613100|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
613101|NCT00489268|E5|Reported Event|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
613102|NCT00489268|E4|Reported Event|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
613103|NCT00489268|E3|Reported Event|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
613104|NCT00489268|E2|Reported Event|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
613208|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
613209|NCT00488774|E4|Reported Event|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
613105|NCT00489268|E1|Reported Event|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
613106|NCT00489255|B3|Baseline|Total|Total of all reporting groups
613107|NCT00489255|B2|Baseline|Placebo|Placebo : Oral capsule, three times daily.
613108|NCT00489255|B1|Baseline|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613109|NCT00489255|P2|Participant Flow|Tigan:Placebo|Placebo : Oral capsule, three times daily.
613110|NCT00489255|P1|Participant Flow|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613111|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613112|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613113|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613114|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613115|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613116|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613117|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613118|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613119|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613120|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613121|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613122|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613123|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613124|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613125|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613126|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613127|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613128|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613129|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613130|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613131|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613132|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613133|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613134|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613135|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613136|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613137|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613138|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613139|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613140|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613141|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613142|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613143|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613144|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613145|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613146|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613147|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613148|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613149|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613150|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613151|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613152|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613153|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
613154|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613155|NCT00489255|E2|Reported Event|Placebo|Placebo : Oral capsule, three times daily.
613156|NCT00489255|E1|Reported Event|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
613157|NCT00489216|B1|Baseline|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613158|NCT00489216|P1|Participant Flow|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613210|NCT00488774|E3|Reported Event|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
613213|NCT00488683|B4|Baseline|Total|Total of all reporting groups
613162|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613163|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613164|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613165|NCT00489216|E1|Reported Event|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
613166|NCT00489086|B1|Baseline|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
613167|NCT00489086|P1|Participant Flow|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
613168|NCT00489086|O1|Outcome|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
613169|NCT00489086|E1|Reported Event|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
613170|NCT00488865|B1|Baseline|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
613171|NCT00488865|P1|Participant Flow|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
613172|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
613173|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
613174|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
613175|NCT00488865|E1|Reported Event|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
613176|NCT00488826|B4|Baseline|Total|Total of all reporting groups
613177|NCT00488826|B3|Baseline|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
613178|NCT00488826|B2|Baseline|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
613179|NCT00488826|B1|Baseline|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
613180|NCT00488826|P3|Participant Flow|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
613181|NCT00488826|P2|Participant Flow|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
613182|NCT00488826|P1|Participant Flow|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
613183|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
613184|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
613185|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
613186|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
613187|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
613188|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
613189|NCT00488826|E3|Reported Event|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
613190|NCT00488826|E2|Reported Event|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
613191|NCT00488826|E1|Reported Event|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
613192|NCT00488774|B5|Baseline|Total|Total of all reporting groups
613193|NCT00488774|B4|Baseline|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
613194|NCT00488774|B3|Baseline|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
613195|NCT00488774|B2|Baseline|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
613196|NCT00488774|B1|Baseline|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
613197|NCT00488774|P4|Participant Flow|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
613198|NCT00488774|P3|Participant Flow|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
613199|NCT00488774|P2|Participant Flow|Golimumab 1 Milligram (mg) Per Kilogram (kg)|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
613200|NCT00488774|P1|Participant Flow|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
613201|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
613214|NCT00488683|B3|Baseline|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613215|NCT00488683|B2|Baseline|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613216|NCT00488683|B1|Baseline|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613217|NCT00488683|P3|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613218|NCT00488683|P2|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613219|NCT00488683|P1|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613220|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613221|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613222|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613223|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613224|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613225|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613226|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613227|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613228|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613229|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613283|NCT00488631|B5|Baseline|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
613230|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613231|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613232|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613233|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613234|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613235|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613236|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613237|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613238|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613239|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613240|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613241|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613242|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613243|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613244|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613245|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613246|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613247|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613248|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613249|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613250|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613251|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613252|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613253|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613254|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613255|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613256|NCT00488683|O3|Outcome|MenACWY-CRM + Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613257|NCT00488683|O2|Outcome|MenACWY-CRM + Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613258|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613259|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613260|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613261|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613262|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613382|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
613383|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
621602|NCT00467844|O3|Outcome|Placebo|Placebo
613263|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613264|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613265|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613266|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613267|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613268|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613269|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613270|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613271|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613272|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613273|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613274|NCT00488683|E3|Reported Event|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
613275|NCT00488683|E2|Reported Event|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
613276|NCT00488683|E1|Reported Event|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
613277|NCT00488644|B1|Baseline|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
613278|NCT00488644|P1|Participant Flow|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
613279|NCT00488644|O1|Outcome|8 Weeks Post Therapy|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks.
613280|NCT00488644|E1|Reported Event|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
613281|NCT00488631|B7|Baseline|Total|Total of all reporting groups
613282|NCT00488631|B6|Baseline|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
613384|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
613284|NCT00488631|B4|Baseline|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
613285|NCT00488631|B3|Baseline|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613286|NCT00488631|B2|Baseline|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613287|NCT00488631|B1|Baseline|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
613288|NCT00488631|P10|Participant Flow|Golimumab 200 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
613289|NCT00488631|P9|Participant Flow|Golimumab 100 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
613290|NCT00488631|P8|Participant Flow|Golimumab 50 mg - Extension|Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
613291|NCT00488631|P7|Participant Flow|Placebo Extension|Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
613292|NCT00488631|P6|Participant Flow|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
613293|NCT00488631|P5|Participant Flow|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
613294|NCT00488631|P4|Participant Flow|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
613295|NCT00488631|P3|Participant Flow|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613296|NCT00488631|P2|Participant Flow|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613297|NCT00488631|P1|Participant Flow|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
613385|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
613386|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
621603|NCT00467844|O2|Outcome|GTx-024 3 mg|
613298|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613299|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613300|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
613301|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613302|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613303|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
613304|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613305|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613306|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
613307|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613308|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613309|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
613387|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
613388|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
613310|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613311|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613312|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
613313|NCT00488631|E18|Reported Event|Golimumab 100 mg - 200 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
613314|NCT00488631|E17|Reported Event|Golimumab 50 mg - 100 mg Extension|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
613315|NCT00488631|E16|Reported Event|Placebo - Golimumab100 mg Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
613316|NCT00488631|E15|Reported Event|Placebo - 50 mg Extension|A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
613317|NCT00488631|E14|Reported Event|Golimumab 200 mg Extension|Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
613318|NCT00488631|E13|Reported Event|Golimumab 100 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
613319|NCT00488631|E12|Reported Event|Golimumab 50 mg Extension Phase|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
613320|NCT00488631|E11|Reported Event|Placebo Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
613321|NCT00488631|E10|Reported Event|PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
613322|NCT00488631|E9|Reported Event|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
613323|NCT00488631|E8|Reported Event|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
613324|NCT00488631|E7|Reported Event|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
613389|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
613390|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613325|NCT00488631|E6|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
613326|NCT00488631|E5|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
613327|NCT00488631|E4|Reported Event|GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
613328|NCT00488631|E3|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613329|NCT00488631|E2|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
613330|NCT00488631|E1|Reported Event|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
613331|NCT00488618|B3|Baseline|Total|Total of all reporting groups
613332|NCT00488618|B2|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
613333|NCT00488618|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
613334|NCT00488618|P2|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
613335|NCT00488618|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
613336|NCT00488618|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
613337|NCT00488618|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
613338|NCT00488618|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
613339|NCT00488618|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
613340|NCT00488618|E2|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
613341|NCT00488618|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
613342|NCT00488592|B1|Baseline|WT1/PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
613343|NCT00488592|P1|Participant Flow|WT1/PR1|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
613344|NCT00488592|O1|Outcome|WT1/PR1 Vaccine|Subjects with myeloid malignancies will receive WT1/PR1 vaccine to evaluate immune response to intervention.
613345|NCT00488592|E1|Reported Event|WT1/ PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
613346|NCT00488514|B1|Baseline|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
613347|NCT00488514|P1|Participant Flow|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. A single Combination Tablet was supplied for each migraine attack, not to exceed one tablet in 24 hours.
613348|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613349|NCT00488514|O2|Outcome|6 Month Completer Population|Participant in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613350|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
613479|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613351|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613352|NCT00488514|O2|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613353|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet drug and had at least one post-treatment migraine assessment
613354|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613355|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
613356|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
613357|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613358|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613359|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
613360|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613361|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613362|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
613363|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613364|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613365|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
613366|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613367|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613368|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
613369|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
613370|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|
613371|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
613372|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
613373|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
613374|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
613375|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
613376|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
613377|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
613378|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
613379|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
613380|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
613381|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
613391|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613392|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613393|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613394|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613395|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613396|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613397|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613398|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet , completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613399|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613400|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613401|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613402|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
613403|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
613404|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613405|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613406|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613407|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613408|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613409|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613410|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613411|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613412|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613413|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613414|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613415|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613416|NCT00488514|E3|Reported Event|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
613417|NCT00488514|E2|Reported Event|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
613418|NCT00488514|E1|Reported Event|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
613419|NCT00488488|B1|Baseline|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613420|NCT00488488|P1|Participant Flow|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613421|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613422|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613423|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613424|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613425|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613426|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613427|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613428|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613429|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613430|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613431|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613432|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613433|NCT00488488|E1|Reported Event|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
613434|NCT00488475|B1|Baseline|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613435|NCT00488475|P1|Participant Flow|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613436|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613437|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613438|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613439|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613440|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613441|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613442|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613443|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613444|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613445|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613446|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613447|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613448|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613449|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613450|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613451|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613452|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613453|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613454|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613455|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613456|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613457|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613458|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613459|NCT00488475|E1|Reported Event|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
613460|NCT00488345|B4|Baseline|Total|Total of all reporting groups
613461|NCT00488345|B3|Baseline|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613462|NCT00488345|B2|Baseline|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613463|NCT00488345|B1|Baseline|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
613464|NCT00488345|P3|Participant Flow|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613465|NCT00488345|P2|Participant Flow|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613466|NCT00488345|P1|Participant Flow|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
613467|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
613468|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
613469|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613470|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613471|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
613472|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
613473|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613474|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613475|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
613476|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613477|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613478|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
614620|NCT00486291|P1|Participant Flow|Active|Phentermine 15mg/topiramate 100mg
613480|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613481|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
613482|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613483|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613484|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
613485|NCT00488345|E3|Reported Event|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
613486|NCT00488345|E2|Reported Event|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
613487|NCT00488345|E1|Reported Event|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
613488|NCT00488319|B4|Baseline|Total|Total of all reporting groups
613489|NCT00488319|B3|Baseline|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613490|NCT00488319|B2|Baseline|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613491|NCT00488319|B1|Baseline|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613492|NCT00488319|P3|Participant Flow|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613493|NCT00488319|P2|Participant Flow|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613494|NCT00488319|P1|Participant Flow|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613495|NCT00488319|O4|Outcome|Total|
613496|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613497|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613498|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613499|NCT00488319|O4|Outcome|Total|
613500|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613626|NCT00488033|B1|Baseline|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613501|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613502|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613503|NCT00488319|O4|Outcome|Total|
613504|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613505|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613506|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613507|NCT00488319|O4|Outcome|Total|
613508|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613509|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613510|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613511|NCT00488319|O4|Outcome|Total|
613512|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613513|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613514|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613515|NCT00488319|O4|Outcome|Total|
613516|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613517|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613518|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613519|NCT00488319|O4|Outcome|Total|
613520|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613521|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613522|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613523|NCT00488319|O4|Outcome|Total|
613524|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613525|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613526|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613527|NCT00488319|O4|Outcome|Total|
613528|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613529|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613530|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613531|NCT00488319|O4|Outcome|Total|
613532|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613533|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613534|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613535|NCT00488319|O4|Outcome|Total|
613536|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613537|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613538|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613539|NCT00488319|O4|Outcome|Total|
613540|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613541|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613542|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613543|NCT00488319|O4|Outcome|Total|
613544|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613545|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613546|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613547|NCT00488319|O4|Outcome|Total|
613548|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613549|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613550|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613551|NCT00488319|O4|Outcome|Total|
613552|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613553|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613554|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613555|NCT00488319|O4|Outcome|Total|
613556|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613557|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613558|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613559|NCT00488319|O4|Outcome|Total|
613560|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613561|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613562|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613563|NCT00488319|O4|Outcome|Total|
613564|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613565|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613566|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613567|NCT00488319|O4|Outcome|Total|
613568|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613569|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613570|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613571|NCT00488319|O4|Outcome|Total|
613572|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613573|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613574|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613575|NCT00488319|E3|Reported Event|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613576|NCT00488319|E2|Reported Event|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613577|NCT00488319|E1|Reported Event|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
613578|NCT00488293|B3|Baseline|Total|Total of all reporting groups
613579|NCT00488293|B2|Baseline|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613580|NCT00488293|B1|Baseline|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613581|NCT00488293|P2|Participant Flow|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613582|NCT00488293|P1|Participant Flow|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613583|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613584|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613585|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613586|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613587|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613588|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613589|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613590|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613591|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613592|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613593|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613594|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613595|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613596|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613597|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613598|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613599|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613600|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613601|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613602|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613603|NCT00488293|E2|Reported Event|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
613604|NCT00488293|E1|Reported Event|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
613605|NCT00488059|B1|Baseline|Phase 1: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
613606|NCT00488059|P3|Participant Flow|Phase II - Arm B|Phase I then enfuvirtide 180 mg SC QD (2 x 90-mg injections) + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
613607|NCT00488059|P2|Participant Flow|Phase II - Arm A|Phase I then enfuvirtide 90 mg SC BID + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
613608|NCT00488059|P1|Participant Flow|Phase I|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
613609|NCT00488059|O3|Outcome|Phase II - Arm B|Phase I then ENF 180 mg SC QD
613610|NCT00488059|O2|Outcome|Phase II - Arm A|Phase I then ENF 90 mg SC BID
613611|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
613612|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613627|NCT00488033|P2|Participant Flow|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613628|NCT00488033|P1|Participant Flow|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613613|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613614|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613615|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613616|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
613617|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613618|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90 mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I+ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613619|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
613620|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
613621|NCT00488059|E3|Reported Event|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized~(Phase II Arm B: Phase I then ENF 180mg SC once daily (QD)): ENF 180 mg SC QD + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613622|NCT00488059|E2|Reported Event|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
613623|NCT00488059|E1|Reported Event|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
613624|NCT00488033|B3|Baseline|Total|Total of all reporting groups
613625|NCT00488033|B2|Baseline|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
614621|NCT00486291|O2|Outcome|Placebo|Matched placebo
613629|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613630|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613631|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613632|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613633|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613634|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613635|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613636|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613637|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613638|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613639|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613640|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613641|NCT00488033|E2|Reported Event|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
613642|NCT00488033|E1|Reported Event|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
613643|NCT00487981|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
613644|NCT00487981|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
613645|NCT00487981|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
613646|NCT00487981|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
613647|NCT00487942|B5|Baseline|Total|Total of all reporting groups
613648|NCT00487942|B4|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613649|NCT00487942|B3|Baseline|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613650|NCT00487942|B2|Baseline|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613651|NCT00487942|B1|Baseline|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613652|NCT00487942|P4|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613653|NCT00487942|P3|Participant Flow|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613654|NCT00487942|P2|Participant Flow|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613655|NCT00487942|P1|Participant Flow|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613656|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613657|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613658|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614099|NCT00487578|P1|Participant Flow|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
613659|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613660|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613661|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613662|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613663|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613664|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613665|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613666|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613667|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613668|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613669|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613670|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613671|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613672|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613673|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613674|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613675|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613676|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613677|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613678|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613679|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613680|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613681|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613682|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613683|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613684|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613685|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613686|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613687|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613688|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613689|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613690|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613691|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613692|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613693|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613694|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613695|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613696|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613697|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613698|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613699|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613700|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613701|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613702|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613703|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613704|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613705|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613706|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613707|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613708|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613709|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613710|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613711|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613712|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613713|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613714|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613715|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613716|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613717|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613718|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613719|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613720|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613721|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613722|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613723|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613724|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613725|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613726|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613727|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613728|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613729|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613730|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613731|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613732|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613733|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613734|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613735|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613736|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613737|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613738|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613739|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613740|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613741|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613742|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613743|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613744|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613745|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613746|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613747|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613748|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613749|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613750|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613751|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613752|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613753|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613754|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613755|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613756|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613757|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613758|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613759|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613760|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613761|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613762|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613763|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613764|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613765|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613766|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613767|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613768|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613769|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613770|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613771|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613772|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613773|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613774|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613775|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613776|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613777|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613778|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613779|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613780|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613781|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613782|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613783|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613784|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613785|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613786|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613787|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613788|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613789|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613790|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613791|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613792|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613793|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613794|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613795|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613796|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613797|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613798|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613799|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613800|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613801|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613802|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613803|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613804|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613805|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613806|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613807|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613808|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613809|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613810|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613811|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613812|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613813|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613814|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613815|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613816|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613817|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613818|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613819|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613820|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613821|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613822|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613823|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613824|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613825|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613826|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613827|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613828|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613829|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613830|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613831|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613832|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613833|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613834|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613835|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613836|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613837|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613838|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613839|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613840|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613841|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613842|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613843|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613844|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613845|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613846|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613847|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613848|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613849|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613850|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613851|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613852|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613853|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613854|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613855|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613856|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613857|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613858|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613859|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613860|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613861|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613862|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613863|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613864|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613865|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613866|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613867|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613868|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613869|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613870|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613871|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613872|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613873|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613874|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613875|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613876|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613877|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613878|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613879|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613880|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613881|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613882|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613883|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613884|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613885|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613886|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613887|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613888|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613889|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613890|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613891|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613892|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613893|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613894|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613895|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613896|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613897|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613898|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613899|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613900|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613901|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613902|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613903|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613904|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613905|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613906|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613907|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613908|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613909|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613910|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613911|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613912|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613913|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613914|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613915|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613916|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613917|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613918|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613919|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613920|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613921|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613922|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613923|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613924|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613925|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613926|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613927|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613928|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613929|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613930|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613931|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613932|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613933|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613934|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613935|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613936|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613937|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613938|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613939|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613940|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613941|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613942|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613943|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613944|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613945|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613946|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613947|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613948|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613949|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613950|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613951|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613952|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613953|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613954|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613955|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613956|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613957|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613958|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613959|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613960|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613961|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613962|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613963|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613964|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613965|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613966|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613967|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613968|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613969|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613970|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613971|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613972|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613973|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613974|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613975|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613976|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613977|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613978|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613979|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613980|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613981|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613982|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613983|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613984|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613985|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613986|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613987|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613988|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613989|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613990|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613991|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613992|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613993|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613994|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613995|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
613996|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
613997|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
613998|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
613999|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614000|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614001|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614002|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614003|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614004|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614005|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614006|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614007|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614008|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614009|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614010|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614011|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614012|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614013|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614014|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614015|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614016|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614017|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614018|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614019|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614020|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614021|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614022|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614023|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614024|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614025|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614026|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614027|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614028|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614029|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614030|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614031|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614032|NCT00487942|E4|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
614033|NCT00487942|E3|Reported Event|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
614034|NCT00487942|E2|Reported Event|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
614035|NCT00487942|E1|Reported Event|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
614036|NCT00487825|B3|Baseline|Total|Total of all reporting groups
614037|NCT00487825|B2|Baseline|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
614038|NCT00487825|B1|Baseline|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
614039|NCT00487825|P2|Participant Flow|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
614071|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614040|NCT00487825|P1|Participant Flow|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
614041|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
614042|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
614043|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
614044|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
614045|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
614046|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
614047|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
614048|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
614049|NCT00487825|E2|Reported Event|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
614050|NCT00487825|E1|Reported Event|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
614051|NCT00487747|B1|Baseline|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614052|NCT00487747|P1|Participant Flow|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a [Pegasys], 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614053|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614054|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614055|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614056|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614057|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614058|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614059|NCT00487747|E1|Reported Event|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
614060|NCT00487721|B3|Baseline|Total|Total of all reporting groups
614061|NCT00487721|B2|Baseline|Control|Subjects in the control arm did not receive any treatment or placebo.
614062|NCT00487721|B1|Baseline|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
614063|NCT00487721|P2|Participant Flow|Control|Subjects in the control arm did not receive any treatment or placebo.
614064|NCT00487721|P1|Participant Flow|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
614065|NCT00487721|O1|Outcome|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
614066|NCT00487721|E2|Reported Event|Control|Subjects in the control arm did not receive any treatment or placebo.
614067|NCT00487721|E1|Reported Event|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
614068|NCT00487695|B1|Baseline|All Study Participants|Patients received both procedures (CLE and standard EGD), so baseline characteristics are reported for the group
614069|NCT00487695|P2|Participant Flow|Standard EGD Followed by CLE|Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later
614070|NCT00487695|P1|Participant Flow|CLE Followed by Standard EGD|Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy
614622|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
614072|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614073|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614074|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614075|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614076|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614077|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614078|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614079|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614080|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614081|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614082|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
614083|NCT00487695|E2|Reported Event|Standard EGD|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
614084|NCT00487695|E1|Reported Event|Confocal Laser Endomicroscopy|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
614085|NCT00487669|B1|Baseline|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
614086|NCT00487669|P1|Participant Flow|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
614087|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
614088|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
614089|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
614090|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
614091|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
614092|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
614093|NCT00487669|E2|Reported Event|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
614094|NCT00487669|E1|Reported Event|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
614095|NCT00487578|B3|Baseline|Total|Total of all reporting groups
614096|NCT00487578|B2|Baseline|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614097|NCT00487578|B1|Baseline|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614098|NCT00487578|P2|Participant Flow|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614623|NCT00486291|O2|Outcome|Placebo|Matched placebo
614100|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614101|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614102|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614103|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614104|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614105|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614106|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614107|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614108|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614109|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614110|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614111|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614112|NCT00487578|E2|Reported Event|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614113|NCT00487578|E1|Reported Event|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
614114|NCT00487565|B1|Baseline|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
614115|NCT00487565|P1|Participant Flow|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
614116|NCT00487565|O1|Outcome|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
614117|NCT00487565|E1|Reported Event|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
614118|NCT00487552|B1|Baseline|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
614119|NCT00487552|P1|Participant Flow|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
614120|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD)|Magnetic Anastomosis Device (MAD) used for palliative treatment of gastric outlet obstruction.
614121|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
614122|NCT00487552|E1|Reported Event|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
614123|NCT00487539|B5|Baseline|Total|Total of all reporting groups
614124|NCT00487539|B4|Baseline|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
614125|NCT00487539|B3|Baseline|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
614126|NCT00487539|B2|Baseline|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
614127|NCT00487539|B1|Baseline|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
614128|NCT00487539|P4|Participant Flow|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
614129|NCT00487539|P3|Participant Flow|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
614130|NCT00487539|P2|Participant Flow|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
614131|NCT00487539|P1|Participant Flow|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
614132|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
614133|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
614134|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
614135|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
614136|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
614137|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
614138|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
614139|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
614140|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
614141|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
614142|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
614143|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
614144|NCT00487539|E4|Reported Event|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
614145|NCT00487539|E3|Reported Event|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
614146|NCT00487539|E2|Reported Event|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
614147|NCT00487539|E1|Reported Event|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
614148|NCT00487461|B4|Baseline|Total|Total of all reporting groups
614149|NCT00487461|B3|Baseline|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614150|NCT00487461|B2|Baseline|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614151|NCT00487461|B1|Baseline|Control Group|"Placebo tablet~Placebo: Placebo tablet"
614152|NCT00487461|P3|Participant Flow|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614153|NCT00487461|P2|Participant Flow|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614154|NCT00487461|P1|Participant Flow|Control Group|"Placebo tablet~Placebo: Placebo tablet"
614155|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614156|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614157|NCT00487461|O1|Outcome|Control Group|"Placebo tablet~Placebo: Placebo tablet"
614158|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614159|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614160|NCT00487461|O1|Outcome|Control Group|"Placebo tablet~Placebo: Placebo tablet"
614161|NCT00487461|E3|Reported Event|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614162|NCT00487461|E2|Reported Event|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
614163|NCT00487461|E1|Reported Event|Control Group|"Placebo tablet~Placebo: Placebo tablet"
614164|NCT00487435|B1|Baseline|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
614165|NCT00487435|P1|Participant Flow|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
614166|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
614167|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
614168|NCT00487435|E1|Reported Event|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
614169|NCT00487396|B1|Baseline|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
614170|NCT00487396|P1|Participant Flow|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
614171|NCT00487396|O2|Outcome|Small Bowel Follow Through(SBFT) Followed by Ileo-colonoscopy|Patients subsequently had SBFT followed by ileo-colonoscopy .
614172|NCT00487396|O1|Outcome|PillCam SB Followed by Ileo Colonoscopy|Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.
614173|NCT00487396|E2|Reported Event|Adverse Events Related to Capsule|AE related to the capsule endoscopy procedure
614174|NCT00487396|E1|Reported Event|Adverse Events Related to Ileocolonoscopy|AE related to the ileocolonoscopy procedure
614175|NCT00487279|B3|Baseline|Total|Total of all reporting groups
614176|NCT00487279|B2|Baseline|Control Group|Medical therapy alone
614177|NCT00487279|B1|Baseline|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
614178|NCT00487279|P2|Participant Flow|Control Group|Medical therapy alone
614179|NCT00487279|P1|Participant Flow|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
614180|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
614181|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
614182|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
614183|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
614184|NCT00487279|E2|Reported Event|Control Group|Medical therapy alone
614185|NCT00487279|E1|Reported Event|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
614186|NCT00487240|B3|Baseline|Total|Total of all reporting groups
614187|NCT00487240|B2|Baseline|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614188|NCT00487240|B1|Baseline|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614189|NCT00487240|P2|Participant Flow|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614190|NCT00487240|P1|Participant Flow|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614191|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614192|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614193|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614194|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614195|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614196|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614197|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614198|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614199|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614200|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614201|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614202|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614203|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614204|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614205|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614206|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614207|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614208|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614209|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614210|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614211|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614212|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614213|NCT00487240|E2|Reported Event|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
614214|NCT00487240|E1|Reported Event|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
614215|NCT00487188|B3|Baseline|Total|Total of all reporting groups
614216|NCT00487188|B2|Baseline|HAART|Participants received highly active antiretroviral treatment.
614217|NCT00487188|B1|Baseline|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
614218|NCT00487188|P3|Participant Flow|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
614219|NCT00487188|P2|Participant Flow|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
614220|NCT00487188|P1|Participant Flow|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
614221|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
614222|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
614223|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
614224|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
614225|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
614226|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
614227|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
614228|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
614229|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
614288|NCT00487084|E1|Reported Event|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
614230|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
614231|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
614232|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
614233|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
614234|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
614235|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
614236|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
614237|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
614238|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
614239|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
614240|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who were randomized to ENF+HAART at BL1 and follows the patients throughout 48 weeks, regardless of which arm they were randomized to at BL2."
614241|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
614242|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
614243|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
614244|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
614245|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
614246|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
614247|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
614248|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
614249|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
614250|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
614251|NCT00487188|E5|Reported Event|Maintenance Phase: HAART|During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.
614252|NCT00487188|E4|Reported Event|Maintenance Phase: HAART (ENF Removed)|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.
614253|NCT00487188|E3|Reported Event|Maintenance Phase: ENF + HAART|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.
614254|NCT00487188|E2|Reported Event|Induction Phase: HAART|During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.
614255|NCT00487188|E1|Reported Event|Induction: ENF+HAART|During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.
614256|NCT00487162|B3|Baseline|Total|Total of all reporting groups
614257|NCT00487162|B2|Baseline|Intensive Glycemic Control|In this treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL.
614258|NCT00487162|B1|Baseline|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200 mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
614289|NCT00486954|B5|Baseline|Total|Total of all reporting groups
614290|NCT00486954|B4|Baseline|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614259|NCT00487162|P2|Participant Flow|Intensive Glycemic Control|In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.
614260|NCT00487162|P1|Participant Flow|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.
614261|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
614262|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
614263|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
614264|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
614265|NCT00487162|E2|Reported Event|Intensive Glycemic Control|Subjects randomized to this group had glucose levels monitored hourly and when >110mg/dL an insulin drip was initiated to maintain glucose levels between 80-110
614266|NCT00487162|E1|Reported Event|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
614267|NCT00487084|B4|Baseline|Total|Total of all reporting groups
614268|NCT00487084|B3|Baseline|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
614269|NCT00487084|B2|Baseline|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
614270|NCT00487084|B1|Baseline|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
614271|NCT00487084|P3|Participant Flow|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
614272|NCT00487084|P2|Participant Flow|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
614273|NCT00487084|P1|Participant Flow|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
614274|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
614275|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
614276|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
614277|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
614278|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
614279|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
614280|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
614281|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
614282|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
614283|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
614284|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
614285|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
614286|NCT00487084|E3|Reported Event|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
614287|NCT00487084|E2|Reported Event|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
614434|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614291|NCT00486954|B3|Baseline|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614292|NCT00486954|B2|Baseline|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614293|NCT00486954|B1|Baseline|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614294|NCT00486954|P5|Participant Flow|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614295|NCT00486954|P4|Participant Flow|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614296|NCT00486954|P3|Participant Flow|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614297|NCT00486954|P2|Participant Flow|Lapatinib Plus Paclitaxel in Partial Gastrectomy Participants|Participants with partial gastrectomy (which includes preservation of the pylorus) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Partial gastrectomy (pylorus preserved) is very rare population in Japan. As a result, no such participants were recruited into this cohort.
614298|NCT00486954|P1|Participant Flow|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614299|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614300|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614301|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614302|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614303|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614304|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614305|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614306|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614307|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614308|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614309|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614310|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614311|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614312|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614313|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614314|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614315|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614624|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
614316|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614317|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614318|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614319|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614320|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614321|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614322|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614323|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614324|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614325|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614326|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614327|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614328|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614329|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614330|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614331|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614332|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614333|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614334|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614335|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614336|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614337|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614338|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614339|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614340|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614341|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614342|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614343|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614389|NCT00486954|E4|Reported Event|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614344|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614345|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614346|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614347|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614348|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614349|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614350|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614351|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614352|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614353|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614354|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614355|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614356|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614357|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614358|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614359|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614360|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614361|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614362|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614363|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614364|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614365|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614366|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614367|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614368|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614369|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614370|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614371|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614372|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614373|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614374|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614375|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614376|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614377|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614378|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614379|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614380|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614381|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614382|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614383|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614384|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614385|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614386|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614387|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614388|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614625|NCT00486291|E2|Reported Event|Placebo|Matched placebo
614390|NCT00486954|E3|Reported Event|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
614391|NCT00486954|E2|Reported Event|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
614392|NCT00486954|E1|Reported Event|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
614393|NCT00486902|B3|Baseline|Total|Total of all reporting groups
614394|NCT00486902|B2|Baseline|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614395|NCT00486902|B1|Baseline|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614396|NCT00486902|P2|Participant Flow|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614397|NCT00486902|P1|Participant Flow|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614398|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614399|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614400|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614401|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614402|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614403|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614404|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614405|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614406|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614407|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614408|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614409|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614410|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614411|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614412|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614413|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614414|NCT00486902|E2|Reported Event|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
614415|NCT00486902|E1|Reported Event|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
614416|NCT00486863|B3|Baseline|Total|Total of all reporting groups
614417|NCT00486863|B2|Baseline|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614418|NCT00486863|B1|Baseline|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614419|NCT00486863|P2|Participant Flow|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours. The agent was gel encapsulated to reduce appreciation of odor and taste and mimic appearance of the placebo.
614420|NCT00486863|P1|Participant Flow|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules as the test agent, but with the inert compound dextrose.
614421|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614422|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614423|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614424|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614425|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614426|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614427|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614428|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614429|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614430|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614431|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614432|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614433|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614547|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
614435|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614436|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614437|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614438|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614439|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614440|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614441|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614442|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614443|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614444|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614445|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614446|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614447|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614448|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614449|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614450|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614451|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614452|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614453|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614454|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614455|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614456|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614457|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614458|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614459|NCT00486863|E2|Reported Event|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
614460|NCT00486863|E1|Reported Event|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
614461|NCT00486837|B3|Baseline|Total|Total of all reporting groups
614462|NCT00486837|B2|Baseline|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
614463|NCT00486837|B1|Baseline|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
614464|NCT00486837|P2|Participant Flow|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
614465|NCT00486837|P1|Participant Flow|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
614466|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614467|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614468|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614469|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614470|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614471|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614472|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614473|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614474|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614475|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
614476|NCT00486837|O2|Outcome|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
614477|NCT00486837|O1|Outcome|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
614478|NCT00486837|E2|Reported Event|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
614479|NCT00486837|E1|Reported Event|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
614480|NCT00486811|B4|Baseline|Total|Total of all reporting groups
614481|NCT00486811|B3|Baseline|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614482|NCT00486811|B2|Baseline|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614483|NCT00486811|B1|Baseline|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614484|NCT00486811|P3|Participant Flow|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614485|NCT00486811|P2|Participant Flow|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614486|NCT00486811|P1|Participant Flow|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614487|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614488|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614489|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614490|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614491|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614492|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614548|NCT00486720|E2|Reported Event|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
614626|NCT00486291|E1|Reported Event|Active|Phentermine 15mg/topiramate 100mg
614493|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614494|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614495|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614496|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614497|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614498|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614499|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614500|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614501|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614502|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614503|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614504|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614505|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614506|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614549|NCT00486720|E1|Reported Event|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
614507|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614508|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614509|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614510|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614511|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614512|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614513|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614514|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614515|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614516|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614517|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614518|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614519|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614520|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614550|NCT00486642|B3|Baseline|Total|Total of all reporting groups
614821|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614521|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614522|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614523|NCT00486811|E3|Reported Event|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
614524|NCT00486811|E2|Reported Event|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
614525|NCT00486811|E1|Reported Event|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
614526|NCT00486759|B3|Baseline|Total|Total of all reporting groups
614527|NCT00486759|B2|Baseline|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614528|NCT00486759|B1|Baseline|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614529|NCT00486759|P2|Participant Flow|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614530|NCT00486759|P1|Participant Flow|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614531|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614532|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614533|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614534|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614535|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614536|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614537|NCT00486759|E2|Reported Event|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614538|NCT00486759|E1|Reported Event|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
614539|NCT00486720|B3|Baseline|Total|Total of all reporting groups
614540|NCT00486720|B2|Baseline|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
614541|NCT00486720|B1|Baseline|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
614542|NCT00486720|P2|Participant Flow|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
614543|NCT00486720|P1|Participant Flow|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
614544|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
614545|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
614546|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
614551|NCT00486642|B2|Baseline|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614552|NCT00486642|B1|Baseline|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614553|NCT00486642|P2|Participant Flow|Arm II (Pazopanib & Bicalutamide)|Arm II - Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
614554|NCT00486642|P1|Participant Flow|Arm I (Pazopanib)|"Arm I - Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614555|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614556|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614557|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614558|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614559|NCT00486642|O2|Outcome|Arm B (Pazopanib + Bicalutamide)|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614560|NCT00486642|O1|Outcome|Arm A (Pazopanib)|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614561|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614562|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614563|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614564|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614565|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614566|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614567|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614568|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614569|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614570|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614571|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614572|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614573|NCT00486642|E2|Reported Event|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614574|NCT00486642|E1|Reported Event|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
614575|NCT00486525|B3|Baseline|Total|Total of all reporting groups
614615|NCT00486330|E1|Reported Event|Tipranavir/Ritonavir (500mg/200mg)|
614576|NCT00486525|B2|Baseline|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614577|NCT00486525|B1|Baseline|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614578|NCT00486525|P2|Participant Flow|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614579|NCT00486525|P1|Participant Flow|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614580|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614581|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614582|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614583|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614584|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614585|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614586|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614587|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614588|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614589|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614590|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614591|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614592|NCT00486525|E2|Reported Event|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
614593|NCT00486525|E1|Reported Event|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
614594|NCT00486447|B1|Baseline|Imaging|"General imaging subjects receiving CT exams~64 Channel VCT: cardiac CT angiography exam"
614595|NCT00486447|P1|Participant Flow|Imaging|Enrolled subjects for general imaging
614596|NCT00486447|O1|Outcome|Outcome Measure 2|1 year clinical outcome follow-up (Study terminated prior to collection)
614597|NCT00486447|O1|Outcome|Enrolled|Enrolled subjects for general imaging
614598|NCT00486447|E1|Reported Event|Enrolled|Subjects receiving diagnostic CT scans
614599|NCT00486434|B3|Baseline|Total|Total of all reporting groups
614600|NCT00486434|B2|Baseline|Placebo Arm|1 SMC021 Placebo tablet twice daily
614601|NCT00486434|B1|Baseline|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
614602|NCT00486434|P2|Participant Flow|Placebo Arm|1 SMC021 Placebo tablet twice daily
614603|NCT00486434|P1|Participant Flow|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
614604|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
614605|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
614606|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
614607|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
614608|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
614609|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
614610|NCT00486434|E2|Reported Event|Placebo Arm|1 SMC021 Placebo tablet twice daily
614611|NCT00486434|E1|Reported Event|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
614612|NCT00486330|B1|Baseline|Tipranavir/Ritonavir (500mg/200mg)|
614613|NCT00486330|P1|Participant Flow|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
614614|NCT00486330|O1|Outcome|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
614627|NCT00486278|B1|Baseline|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
614628|NCT00486278|P1|Participant Flow|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
614629|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614630|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614631|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614632|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614633|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614634|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614635|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614636|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614637|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614638|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614639|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614640|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614641|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614642|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614643|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614644|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614645|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614646|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614647|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614648|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614649|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614650|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614651|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614652|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614653|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614654|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614655|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614656|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614657|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614658|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614659|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614660|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614661|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614662|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614663|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614664|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614665|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614666|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614667|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614668|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614669|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614670|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614671|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614672|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614673|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614674|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614675|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614900|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614676|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614677|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614678|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614679|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614680|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614681|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614682|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614683|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614684|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614685|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614686|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614687|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614688|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614689|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614690|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614691|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614692|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614693|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614694|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614695|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614696|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614697|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614698|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614699|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614960|NCT00485433|B4|Baseline|SKY0402 High Dose|SKY0402 high dose given during hernia repair
614700|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614701|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614702|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614703|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614704|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614705|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614706|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614707|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614708|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614709|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614710|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614711|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614712|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614713|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614714|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614715|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614716|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614717|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614718|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614719|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614720|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614721|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614722|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614723|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614961|NCT00485433|B3|Baseline|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
614724|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614725|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614726|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614727|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614728|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614729|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614730|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614731|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614732|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614733|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614734|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614735|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614736|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614737|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614738|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614739|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614740|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614741|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614742|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614743|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614744|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614745|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614746|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614747|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614962|NCT00485433|B2|Baseline|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
614748|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614749|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614750|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614751|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614752|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614753|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614754|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614755|NCT00486278|E6|Reported Event|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
614756|NCT00486278|E5|Reported Event|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614757|NCT00486278|E4|Reported Event|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614758|NCT00486278|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614759|NCT00486278|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614760|NCT00486278|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
614761|NCT00486265|B1|Baseline|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
614762|NCT00486265|P1|Participant Flow|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
614763|NCT00486265|O1|Outcome|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
614764|NCT00486265|E1|Reported Event|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
614765|NCT00486252|B1|Baseline|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614766|NCT00486252|P1|Participant Flow|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614767|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614768|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614769|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614770|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614771|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614772|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614773|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614774|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614775|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614776|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614963|NCT00485433|B1|Baseline|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
614777|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614778|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614779|NCT00486252|E1|Reported Event|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
614780|NCT00486226|B1|Baseline|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
614781|NCT00486226|P1|Participant Flow|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD).~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
614782|NCT00486226|O2|Outcome|Endovascular - Occlusion Results at 6 Months Follow-up|Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
614783|NCT00486226|O1|Outcome|Endovascular - Occlusion Results Immediately Post-procedure|Aneurysm occlusion was assessed immediately post procedure using the Raymond Scale.
614784|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
614785|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
614786|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
614787|NCT00486226|E1|Reported Event|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
614788|NCT00486044|B3|Baseline|Total|Total of all reporting groups
614789|NCT00486044|B2|Baseline|Placebo|Matching placebo tablet nightly for 9 months
614790|NCT00486044|B1|Baseline|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
614791|NCT00486044|P2|Participant Flow|Placebo|Matching placebo tablet nightly for 9 months
614792|NCT00486044|P1|Participant Flow|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
614793|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
614794|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
614795|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
614796|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
614797|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
614798|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
614799|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
614800|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
614801|NCT00486044|E2|Reported Event|Placebo|Matching placebo tablet nightly for 9 months
614802|NCT00486044|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
614803|NCT00486031|B1|Baseline|Balsalazide Disodium Tabs,3.3 g BID,|balsalazide disodium tablets,3.3 g BID,
614804|NCT00486031|P1|Participant Flow|Balsalazide Disodium Tabs,3.3 g BID|Balsalazide Disodium tablets,3.3 g BID
614805|NCT00486031|O1|Outcome|Balsalazide Disodium|balsalazide disodium tablets,3.3 g BID,
614806|NCT00486031|E1|Reported Event|Balsalazide Disodium|balsalazide disodium tablets,3.3 g BID,
614807|NCT00486018|B4|Baseline|Total|Total of all reporting groups
614808|NCT00486018|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614809|NCT00486018|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614810|NCT00486018|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614811|NCT00486018|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614812|NCT00486018|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614813|NCT00486018|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614814|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614815|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614816|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614817|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614818|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614819|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614820|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614822|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614823|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614824|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614825|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614826|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614827|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614828|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614829|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614830|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614831|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614832|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614833|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614834|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614835|NCT00486018|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614836|NCT00486018|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614837|NCT00486018|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614838|NCT00485953|B3|Baseline|Total|Total of all reporting groups
614839|NCT00485953|B2|Baseline|Placebo Group|Received placebo medication once per week
614840|NCT00485953|B1|Baseline|Active Medicine Group|risedronate 35 mg weekly
614841|NCT00485953|P2|Participant Flow|Placebo Group|Received placebo medication once per week
614842|NCT00485953|P1|Participant Flow|Active Medication Group|"risedronate 35 mg weekly~risedronate: risedronate 35 mg per week"
614843|NCT00485953|O2|Outcome|Placebo Group|Received placebo medication once weekly
614844|NCT00485953|O1|Outcome|Active Medicine Group|risedronate 35 mg weekly
614845|NCT00485953|O2|Outcome|Placebo Group|Placebo medication once weekly
614846|NCT00485953|O1|Outcome|Active Medication Group|risedronate 35 mg weekly
614847|NCT00485953|O2|Outcome|Placebo Group|Received placebo medication once weekly
614848|NCT00485953|O1|Outcome|Active Medicine Group|risedronate 35 mg weekly
614849|NCT00485953|E2|Reported Event|Placebo Group|Receive placebo medication once per week
614850|NCT00485953|E1|Reported Event|Active Medicine Group|risedronate 35 mg weekly
614851|NCT00485836|B4|Baseline|Total|Total of all reporting groups
614852|NCT00485836|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614853|NCT00485836|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614854|NCT00485836|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614855|NCT00485836|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614856|NCT00485836|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614857|NCT00485836|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614858|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614859|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614860|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614861|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614862|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614863|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614864|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614964|NCT00485433|P4|Participant Flow|SKY0402 High Dose|SKY0402 high dose given during hernia repair
614865|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614866|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614867|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614868|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614869|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614870|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614871|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614872|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614873|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614874|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614875|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614876|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614877|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614878|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614879|NCT00485836|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614880|NCT00485836|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
614881|NCT00485836|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
614882|NCT00485758|B3|Baseline|Total|Total of all reporting groups
614883|NCT00485758|B2|Baseline|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
614884|NCT00485758|B1|Baseline|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
614885|NCT00485758|P2|Participant Flow|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
614886|NCT00485758|P1|Participant Flow|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
614887|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
614888|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
614889|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
614890|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
614891|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
614892|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
614893|NCT00485758|E2|Reported Event|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
614894|NCT00485758|E1|Reported Event|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
614895|NCT00485732|B3|Baseline|Total|Total of all reporting groups
614896|NCT00485732|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614897|NCT00485732|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614898|NCT00485732|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614899|NCT00485732|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614901|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614902|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614903|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614904|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614905|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614906|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614907|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614908|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614909|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614910|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614911|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614912|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614913|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614914|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614915|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614916|NCT00485732|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
614917|NCT00485732|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
614918|NCT00485693|B3|Baseline|Total|Total of all reporting groups
614919|NCT00485693|B2|Baseline|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
614920|NCT00485693|B1|Baseline|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
614921|NCT00485693|P2|Participant Flow|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
614922|NCT00485693|P1|Participant Flow|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
614923|NCT00485693|O5|Outcome|SKY0402 High Dose|Single administration of study drug in a volume of 60 mL via local infiltration
614924|NCT00485693|O4|Outcome|SKY0402 High-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
614925|NCT00485693|O3|Outcome|SKY0402 Low-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
614926|NCT00485693|O2|Outcome|SKY0402 Low Dose|Single administration of study drug in a volume of 60 mL via local infiltration
614927|NCT00485693|O1|Outcome|Bupivacaine HCl|Single administration of 150 mg bupivacaine HCl in a 60-mL injection volume (undiluted)
614928|NCT00485693|E2|Reported Event|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
614929|NCT00485693|E1|Reported Event|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
614930|NCT00485485|B1|Baseline|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
614931|NCT00485485|P1|Participant Flow|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
614932|NCT00485485|O1|Outcome|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
614933|NCT00485485|E1|Reported Event|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
614934|NCT00485472|B3|Baseline|Total|Total of all reporting groups
614935|NCT00485472|B2|Baseline|Placebo|Placebo
614936|NCT00485472|B1|Baseline|Lacosamide|Lacosamide (LCM) 400 mg/day
614937|NCT00485472|P2|Participant Flow|Placebo|Placebo
614938|NCT00485472|P1|Participant Flow|Lacosamide|Lacosamide (LCM) 400 mg/day
614939|NCT00485472|O2|Outcome|Placebo|Placebo
614940|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614941|NCT00485472|O2|Outcome|Placebo|Placebo
614942|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614943|NCT00485472|O2|Outcome|Placebo|Placebo
614944|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614945|NCT00485472|O2|Outcome|Placebo|Placebo
614946|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614947|NCT00485472|O2|Outcome|Placebo|Placebo
614948|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614949|NCT00485472|O2|Outcome|Placebo|Placebo
614950|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614951|NCT00485472|O2|Outcome|Placebo|Placebo
614952|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614953|NCT00485472|O2|Outcome|Placebo|Placebo
614954|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614955|NCT00485472|O2|Outcome|Placebo|Placebo
614956|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
614957|NCT00485472|E2|Reported Event|Placebo|Placebo
614958|NCT00485472|E1|Reported Event|Lacosamide|Lacosamide (LCM) 400 mg/day
614959|NCT00485433|B5|Baseline|Total|Total of all reporting groups
614965|NCT00485433|P3|Participant Flow|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
614966|NCT00485433|P2|Participant Flow|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
614967|NCT00485433|P1|Participant Flow|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
614968|NCT00485433|O4|Outcome|SKY0402 High Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
614969|NCT00485433|O3|Outcome|SKY0402 Middle Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
614970|NCT00485433|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
614971|NCT00485433|O1|Outcome|Bupivacaine HCl 105mg|A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery
614972|NCT00485433|E2|Reported Event|SKY0402 (All Doses)|SKY0402 given during hernia repair
614973|NCT00485433|E1|Reported Event|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
614974|NCT00485303|B1|Baseline|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614975|NCT00485303|P1|Participant Flow|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614976|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614977|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614978|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614979|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614980|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614981|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614982|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614983|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614984|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614985|NCT00485303|E1|Reported Event|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
614986|NCT00485264|B7|Baseline|Total|Total of all reporting groups
614987|NCT00485264|B6|Baseline|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data..
614988|NCT00485264|B5|Baseline|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
614989|NCT00485264|B4|Baseline|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
614990|NCT00485264|B3|Baseline|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
614991|NCT00485264|B2|Baseline|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
614992|NCT00485264|B1|Baseline|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
614993|NCT00485264|P6|Participant Flow|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
614994|NCT00485264|P5|Participant Flow|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
614995|NCT00485264|P4|Participant Flow|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
614996|NCT00485264|P3|Participant Flow|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
614997|NCT00485264|P2|Participant Flow|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
614998|NCT00485264|P1|Participant Flow|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
614999|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615000|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615001|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615002|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615003|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615004|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615005|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615006|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615007|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615008|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615009|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615010|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615011|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615012|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615013|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615014|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615015|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615016|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615017|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data..
615018|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615019|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615020|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615021|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615022|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615271|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615272|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615023|NCT00485264|O6|Outcome|Cohort V -Data Not Included in This Interim Analysis.|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615024|NCT00485264|O5|Outcome|Cohort IV -Data Not Included in This Interim Analysis.|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615025|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615026|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615027|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615028|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615029|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615030|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615031|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615032|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615033|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615034|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615035|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data..
615036|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615037|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615038|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615039|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615040|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615041|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615042|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615043|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615044|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615045|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615046|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615047|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615048|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615049|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615050|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615051|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615052|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615053|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615054|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615055|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615056|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615057|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615058|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615059|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. .
615060|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615061|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615062|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615063|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615064|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615065|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615066|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir granules for oral suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615067|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615068|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615069|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615070|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615071|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615072|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615073|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615074|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615075|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615076|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615077|NCT00485264|E6|Reported Event|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615078|NCT00485264|E5|Reported Event|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data.
615273|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615079|NCT00485264|E4|Reported Event|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615080|NCT00485264|E3|Reported Event|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
615081|NCT00485264|E2|Reported Event|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
615082|NCT00485264|E1|Reported Event|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
615083|NCT00485173|B3|Baseline|Total|Total of all reporting groups
615084|NCT00485173|B2|Baseline|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615085|NCT00485173|B1|Baseline|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615086|NCT00485173|P2|Participant Flow|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615087|NCT00485173|P1|Participant Flow|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615088|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615089|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615090|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615091|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615092|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615093|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615094|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615095|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615096|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615097|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615098|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615099|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615100|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615101|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615102|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615103|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615104|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615105|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615106|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615107|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615108|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615109|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615110|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615111|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615112|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615113|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615114|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615115|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615116|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615117|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615118|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615119|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615120|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615121|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615122|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615123|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615124|NCT00485173|E2|Reported Event|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
615125|NCT00485173|E1|Reported Event|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
615126|NCT00485134|B9|Baseline|Total|Total of all reporting groups
615127|NCT00485134|B8|Baseline|Stage 2: Placebo Group (JHU CIR Site)|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615128|NCT00485134|B7|Baseline|Stage 2: Dolphin 690 ug (JHU CIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615129|NCT00485134|B6|Baseline|Stage 2: Placebo Group (CTC WRAIR Site)|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615130|NCT00485134|B5|Baseline|Stage 2: Dolphin 690 ug (CTC WRAIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615131|NCT00485134|B4|Baseline|Stage 1: Group D, Pipette 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. These subjects received 200 μL the vaccine via electronic pipette. This group is for lot bridging only, not included in dose-finding study.~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615132|NCT00485134|B3|Baseline|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615133|NCT00485134|B2|Baseline|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615134|NCT00485134|B1|Baseline|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615135|NCT00485134|P8|Participant Flow|Stage 2: Placebo Group (JHU CIR Site)|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615136|NCT00485134|P7|Participant Flow|Stage 2: Dolphin 690 ug (JHU CIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615137|NCT00485134|P6|Participant Flow|Stage 2: Placebo Group (CTC WRAIR Site)|"Stage 2: Placebo group (CTC WRAIR site) A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615138|NCT00485134|P5|Participant Flow|Stage 2: Dolphin 690 ug (CTC WRAIR Site)|"690 ug shigella flexneri 2a Invaplex 50 was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615139|NCT00485134|P4|Participant Flow|Stage 1: Group D, Pipette 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. These subjects received 200 μL the vaccine via electronic pipette. This group is for lot bridging only, not included in dose-finding study.~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615140|NCT00485134|P3|Participant Flow|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615141|NCT00485134|P2|Participant Flow|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615142|NCT00485134|P1|Participant Flow|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of lipopolysaccharides (LPS). 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615143|NCT00485134|O3|Outcome|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615184|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615144|NCT00485134|O2|Outcome|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615145|NCT00485134|O1|Outcome|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615146|NCT00485134|O2|Outcome|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615147|NCT00485134|O1|Outcome|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615148|NCT00485134|O2|Outcome|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615149|NCT00485134|O1|Outcome|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615150|NCT00485134|O2|Outcome|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615151|NCT00485134|O1|Outcome|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615152|NCT00485134|O2|Outcome|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615153|NCT00485134|O1|Outcome|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615154|NCT00485134|O2|Outcome|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615155|NCT00485134|O1|Outcome|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T."
615156|NCT00485134|E5|Reported Event|Stage 2: Controls|"A control was to be administered with the Dolphin™ using the vaccination schedule from Stage 1. Non-immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615157|NCT00485134|E4|Reported Event|Stage 2: Immunized|"The selected dose was to be administered with the Dolphin™ using the vaccination schedule from stage 1. Immunized and challenged with Shigella challenge strain approximately 42 days after receiving the last vaccination following a 90-minute fast.~Some individuals were randomly selected for the challenge phase. Shigella challenge strain: 800 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T"
615217|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615274|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615158|NCT00485134|E3|Reported Event|Stage 1: Group C, Dolphin 690 µg|"690 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~690 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615159|NCT00485134|E2|Reported Event|Stage 1: Group B, Dolphin 480 µg|"480 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~480 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615160|NCT00485134|E1|Reported Event|Stage 1: Group A, Dolphin 240 µg|"240 µg Shigella flexneri 2a Invaplex 50 vaccine. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 mL glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. 230 μL of the formulated vaccine (or placebo, sterile saline) was added to a nasal spray applicator (Dolphin™).~240 µg Shigella flexneri 2a Invaplex 50 vaccine: Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris."
615161|NCT00485069|B3|Baseline|Total|Total of all reporting groups
615162|NCT00485069|B2|Baseline|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615163|NCT00485069|B1|Baseline|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615164|NCT00485069|P2|Participant Flow|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615165|NCT00485069|P1|Participant Flow|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615166|NCT00485069|O2|Outcome|"ROP+L-Dopa, On Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615167|NCT00485069|O1|Outcome|"ROP+L-Dopa, Off Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615168|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615169|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615170|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615275|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615171|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615172|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615173|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615174|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615175|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615176|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615177|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615178|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615179|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615180|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615181|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615182|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615183|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615185|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615186|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615187|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615188|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615189|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615190|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off Sate (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615191|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615192|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615193|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615194|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615195|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615196|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615197|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615198|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615199|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615200|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615201|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615202|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615203|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615204|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615205|NCT00485069|E2|Reported Event|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
615206|NCT00485069|E1|Reported Event|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
615207|NCT00484939|B3|Baseline|Total|Total of all reporting groups
615208|NCT00484939|B2|Baseline|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615209|NCT00484939|B1|Baseline|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615210|NCT00484939|P2|Participant Flow|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615211|NCT00484939|P1|Participant Flow|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615212|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615213|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615214|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615215|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615216|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615218|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615219|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615220|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615221|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615222|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615223|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615224|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615225|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615226|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615227|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615228|NCT00484939|E2|Reported Event|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615229|NCT00484939|E1|Reported Event|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
615230|NCT00484679|B1|Baseline|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
615231|NCT00484679|P1|Participant Flow|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
615232|NCT00484679|O1|Outcome|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
615233|NCT00484679|E1|Reported Event|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
615234|NCT00484419|B4|Baseline|Total|Total of all reporting groups
615235|NCT00484419|B3|Baseline|Sitagliptin|sitagliptin phosphate tablets 100mg
615236|NCT00484419|B2|Baseline|Rosiglitazone|rosiglitazone maleate 4mg
615237|NCT00484419|B1|Baseline|Colesevelam|colesevelam tablets 625 mg
615238|NCT00484419|P3|Participant Flow|Sitagliptin|sitagliptin phosphate tablets 100mg
615239|NCT00484419|P2|Participant Flow|Rosiglitazone|rosiglitazone maleate 4mg
615240|NCT00484419|P1|Participant Flow|Colesevelam|colesevelam tablets 625 mg
615241|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615242|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615243|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615244|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615245|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615246|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615247|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615248|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615249|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615250|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615251|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615252|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615253|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615254|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615255|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615256|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615257|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615258|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615259|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615260|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615261|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615262|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615263|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615264|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615265|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615266|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615267|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615268|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615269|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615270|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615276|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615277|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615278|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615279|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615280|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615281|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615282|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615283|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615284|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615285|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615286|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615287|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615288|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615289|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615290|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615291|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615292|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
615293|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
615294|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
615295|NCT00484393|B3|Baseline|Total|Total of all reporting groups
615296|NCT00484393|B2|Baseline|Placebo First|Placebo cream (Aquatain) 1g applied to inejction site first, then tetracaine with subsequent injection
615297|NCT00484393|B1|Baseline|Tetracaine First|Tetracaine 4% gel 1g applied to injection site first, then placebo with subsequent injection
615298|NCT00484393|P2|Participant Flow|Placebo Then Tetracaine|Placebo cream (Aquatain) 1g applied to inejction site prior to next palivizumab injection after enrollment Tetracaine 4% gel 1g applied to injection site prior to subsequent palivizumab injection (1 month after 1st study injection)
615299|NCT00484393|P1|Participant Flow|Tetracaine Then Placebo|Tetracaine 4% gel 1g applied to injection site prior to next palivizumab injection after enrollment Placebo cream (Aquatain) 1g applied to inejction site prior to subsequent palivizumab injection (1 month after 1st study injection)
615300|NCT00484393|O2|Outcome|Placebo|Placebo cream (Aquatain) 1g applied to inejction site
615301|NCT00484393|O1|Outcome|Tetracaine|Tetracaine 4% gel 1g applied to injection site
615302|NCT00484393|E2|Reported Event|Placebo|"Placebo cream (Aquatain) 1g applied to inejction site~Placebo: placebo applied prior to 1 injection"
615303|NCT00484393|E1|Reported Event|Tetracaine|"Tetracaine 4% gel 1g applied to injection site~tetracaine 4% gel: tetracaine applied prior to 1 injection"
615304|NCT00484315|B3|Baseline|Total|Total of all reporting groups
615305|NCT00484315|B2|Baseline|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
615306|NCT00484315|B1|Baseline|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
615307|NCT00484315|P2|Participant Flow|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
615308|NCT00484315|P1|Participant Flow|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
615309|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
615310|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
615311|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
615312|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
615313|NCT00484315|E2|Reported Event|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
615314|NCT00484315|E1|Reported Event|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
615315|NCT00484289|B4|Baseline|Total|Total of all reporting groups
615316|NCT00484289|B3|Baseline|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615317|NCT00484289|B2|Baseline|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615318|NCT00484289|B1|Baseline|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615319|NCT00484289|P3|Participant Flow|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615320|NCT00484289|P2|Participant Flow|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615393|NCT00484185|P1|Participant Flow|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615321|NCT00484289|P1|Participant Flow|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615322|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615323|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615324|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615325|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615326|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615327|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615328|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615329|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615330|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615331|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615332|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615333|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615334|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615335|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615336|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615337|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615338|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615424|NCT00484159|E3|Reported Event|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
615339|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615340|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615341|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615342|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615343|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615344|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615345|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615346|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615347|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615348|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615349|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615350|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615351|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615352|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615353|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615354|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615355|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615356|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615357|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615358|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615359|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615360|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615361|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615362|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615363|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615364|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615365|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615366|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615367|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615368|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615369|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615370|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615371|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615372|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615373|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615374|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615375|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615376|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615377|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615378|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615379|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615380|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615381|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615382|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615383|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615384|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615385|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615386|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615387|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615388|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615389|NCT00484289|E3|Reported Event|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615390|NCT00484289|E2|Reported Event|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
615391|NCT00484289|E1|Reported Event|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
615392|NCT00484185|B1|Baseline|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615425|NCT00484159|E2|Reported Event|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
615394|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615395|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615396|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615397|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615398|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615399|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615400|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615401|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615402|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615403|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615404|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615405|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615406|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615407|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615408|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615409|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615410|NCT00484185|E1|Reported Event|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
615411|NCT00484159|B4|Baseline|Total|Total of all reporting groups
615412|NCT00484159|B3|Baseline|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
615413|NCT00484159|B2|Baseline|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
615414|NCT00484159|B1|Baseline|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
615415|NCT00484159|P3|Participant Flow|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
615416|NCT00484159|P2|Participant Flow|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
615417|NCT00484159|P1|Participant Flow|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
615418|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
615419|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
615420|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
615421|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
615422|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
615423|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
615426|NCT00484159|E1|Reported Event|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
615427|NCT00484094|B1|Baseline|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615428|NCT00484094|P1|Participant Flow|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615429|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615430|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615431|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615432|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615433|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615434|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615435|NCT00484094|E1|Reported Event|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
615436|NCT00483938|B8|Baseline|Total|Total of all reporting groups
615437|NCT00483938|B7|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615438|NCT00483938|B6|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615439|NCT00483938|B5|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
615440|NCT00483938|B4|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615441|NCT00483938|B3|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
615442|NCT00483938|B2|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
615443|NCT00483938|B1|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
615444|NCT00483938|P7|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615445|NCT00483938|P6|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615446|NCT00483938|P5|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
615447|NCT00483938|P4|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615448|NCT00483938|P3|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
615449|NCT00483938|P2|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
615470|NCT00483756|B4|Baseline|Total|Total of all reporting groups
615450|NCT00483938|P1|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
615451|NCT00483938|O6|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615452|NCT00483938|O5|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
615453|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615454|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
615455|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
615456|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
615457|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615458|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
615459|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615460|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
615461|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
615462|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
615463|NCT00483938|E7|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615464|NCT00483938|E6|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615465|NCT00483938|E5|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
615466|NCT00483938|E4|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
615467|NCT00483938|E3|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
615468|NCT00483938|E2|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
615469|NCT00483938|E1|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
615471|NCT00483756|B3|Baseline|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615472|NCT00483756|B2|Baseline|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615473|NCT00483756|B1|Baseline|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615474|NCT00483756|P3|Participant Flow|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615475|NCT00483756|P2|Participant Flow|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615476|NCT00483756|P1|Participant Flow|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615477|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615478|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615479|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615480|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615481|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615482|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615483|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615484|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615485|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615486|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615487|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615488|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615489|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615490|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615491|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615617|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
615618|NCT00483652|E2|Reported Event|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
615492|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615493|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615494|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615495|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615496|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615497|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615498|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615499|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615500|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615501|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615502|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615503|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615504|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615505|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615506|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615507|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615508|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615509|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615510|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615511|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615512|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615619|NCT00483652|E1|Reported Event|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
615620|NCT00483574|B3|Baseline|Total|Total of all reporting groups
615513|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615514|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615515|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615516|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615517|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615518|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615519|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615520|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615521|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615522|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615523|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615524|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615525|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615526|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615527|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615528|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615529|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615530|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615531|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615532|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615533|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615727|NCT00483379|E3|Reported Event|Extension: Alglucosidase Alfa 20 mg/kg Every Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
615534|NCT00483756|E3|Reported Event|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615535|NCT00483756|E2|Reported Event|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
615536|NCT00483756|E1|Reported Event|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
615537|NCT00483717|B3|Baseline|Total|Total of all reporting groups
615538|NCT00483717|B2|Baseline|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615539|NCT00483717|B1|Baseline|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615540|NCT00483717|P2|Participant Flow|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615541|NCT00483717|P1|Participant Flow|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615542|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615543|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615544|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615545|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615546|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615547|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615548|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615549|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615550|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615551|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615552|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615553|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615554|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615555|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615556|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615557|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615558|NCT00483717|E2|Reported Event|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
615559|NCT00483717|E1|Reported Event|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
615560|NCT00483704|B4|Baseline|Total|Total of all reporting groups
615561|NCT00483704|B3|Baseline|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615562|NCT00483704|B2|Baseline|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615563|NCT00483704|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615564|NCT00483704|P3|Participant Flow|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615565|NCT00483704|P2|Participant Flow|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615566|NCT00483704|P1|Participant Flow|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615728|NCT00483379|E2|Reported Event|Treatment: Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615567|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615568|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615569|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615570|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615571|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615572|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615573|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615574|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615575|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615576|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615577|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615578|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615579|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
615580|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
615581|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
615582|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
615583|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
615584|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
615585|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615586|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615587|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615588|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615589|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
617083|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
615590|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615591|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615592|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615593|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615594|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615595|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615596|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615597|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615598|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615599|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615600|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615601|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615602|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615603|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
615604|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
615605|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
615606|NCT00483704|E3|Reported Event|Placebo|Participants who received at least one dose of placebo.
615607|NCT00483704|E2|Reported Event|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
615608|NCT00483704|E1|Reported Event|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
615609|NCT00483652|B3|Baseline|Total|Total of all reporting groups
615610|NCT00483652|B2|Baseline|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
615611|NCT00483652|B1|Baseline|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
615612|NCT00483652|P2|Participant Flow|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
615613|NCT00483652|P1|Participant Flow|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
615614|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
615615|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
615616|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
617084|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
615621|NCT00483574|B2|Baseline|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615622|NCT00483574|B1|Baseline|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615623|NCT00483574|P2|Participant Flow|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615624|NCT00483574|P1|Participant Flow|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615625|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
615626|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMR+V: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. (0.5 mL, intramuscular, respectively)
615627|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615628|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615629|NCT00483574|E2|Reported Event|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615630|NCT00483574|E1|Reported Event|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
615631|NCT00483548|B3|Baseline|Total|Total of all reporting groups
615632|NCT00483548|B2|Baseline|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615633|NCT00483548|B1|Baseline|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615634|NCT00483548|P2|Participant Flow|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615635|NCT00483548|P1|Participant Flow|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615636|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615637|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615638|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615639|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615640|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615641|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615642|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615643|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615644|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615645|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615646|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615647|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615648|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615649|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615650|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615651|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615652|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615653|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615654|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615655|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615656|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615657|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615658|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615659|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615660|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615661|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615662|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615663|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615729|NCT00483379|E1|Reported Event|Treatment: Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615664|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615665|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615666|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615667|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615668|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615669|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615670|NCT00483548|E2|Reported Event|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615671|NCT00483548|E1|Reported Event|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
615672|NCT00483496|B1|Baseline|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
615673|NCT00483496|P1|Participant Flow|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
615674|NCT00483496|O1|Outcome|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
615675|NCT00483496|O8|Outcome|Vehicle|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615676|NCT00483496|O7|Outcome|TiO2Pig|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615677|NCT00483496|O6|Outcome|TiO2 Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615678|NCT00483496|O5|Outcome|Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615679|NCT00483496|O4|Outcome|TiO2Pig + TiO2Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615680|NCT00483496|O3|Outcome|TiO2 Micro + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615681|NCT00483496|O2|Outcome|Ti02Pig + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615682|NCT00483496|O1|Outcome|V0096|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
615683|NCT00483496|E1|Reported Event|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
615684|NCT00483405|B1|Baseline|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
615685|NCT00483405|P1|Participant Flow|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
615686|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
615687|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
615688|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
615689|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
615730|NCT00483327|B1|Baseline|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615690|NCT00483405|E1|Reported Event|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
615691|NCT00483379|B3|Baseline|Total|Total of all reporting groups
615692|NCT00483379|B2|Baseline|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615693|NCT00483379|B1|Baseline|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615694|NCT00483379|P2|Participant Flow|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615695|NCT00483379|P1|Participant Flow|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615696|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615697|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615698|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615699|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615700|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615701|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615702|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615703|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615704|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615705|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615706|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615707|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615708|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615709|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615710|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615711|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615712|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615713|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615714|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615715|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615716|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615717|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615718|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615719|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615720|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615721|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615722|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615723|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615724|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
615725|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
615726|NCT00483379|E4|Reported Event|Extension: Alglucosidase Alfa 40 mg/kg Every Other Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
615731|NCT00483327|P1|Participant Flow|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615732|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615733|NCT00483327|O2|Outcome|Grade 3|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615734|NCT00483327|O1|Outcome|Grade 1 or 2|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615735|NCT00483327|O2|Outcome|Grade 3|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615736|NCT00483327|O1|Outcome|Grade 1 or 2|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615737|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615738|NCT00483327|E1|Reported Event|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
615739|NCT00483262|B3|Baseline|Total|Total of all reporting groups
615740|NCT00483262|B2|Baseline|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib Phase II part of this Phase I/II study
615741|NCT00483262|B1|Baseline|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib Phase I part of this Phase I/II study.
615742|NCT00483262|P2|Participant Flow|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib, Phase II part of this Phase I/II study
615743|NCT00483262|P1|Participant Flow|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib, Phase I part of this Phase I/II study
615744|NCT00483262|O2|Outcome|CCI779 PFS Phase II|Progression-free survival results from the phase II part of the phase I/II CCI779 with velcade study.
615745|NCT00483262|O1|Outcome|CCI779 PFS Phase I|Progression-free survival results from the phase I part of the phase I/II CCI779 with velcade study.
615746|NCT00483262|O2|Outcome|CCI779 Response Phase II|Response of PR or better per the Blade criteria in phase II part of this phase I/II study of CCI779 and velcade
615747|NCT00483262|O1|Outcome|CCI779 Response Phase I|Response of PR or better per the Blade criteria in phase I part of this phase I/II study of CCI779 and velcade
615748|NCT00483262|O2|Outcome|CCI779 Toxicity Phase II|Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
615749|NCT00483262|O1|Outcome|CCI779 Toxicity Phase I|Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
615750|NCT00483262|E2|Reported Event|Adverse Events CCI779 and Bortezomib Phase II|Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
615751|NCT00483262|E1|Reported Event|Adverse Events CCI779 and Bortezomib Phase I|Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
615752|NCT00483223|B1|Baseline|Single Arm|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
615753|NCT00483223|P1|Participant Flow|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
615754|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
615755|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
615756|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
615757|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
615758|NCT00483223|E1|Reported Event|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
615759|NCT00483184|B4|Baseline|Total|Total of all reporting groups
615760|NCT00483184|B3|Baseline|3|(Veldona)1000 IU IFNα bid
615761|NCT00483184|B2|Baseline|2|(Veldona)500 IU IFNα bid
615762|NCT00483184|B1|Baseline|1|(placebo)0 IU IFN alpha
615773|NCT00483119|B2|Baseline|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
615774|NCT00483119|B1|Baseline|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
615775|NCT00483119|P2|Participant Flow|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
615776|NCT00483119|P1|Participant Flow|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
615777|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
615778|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
615779|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
615780|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
615781|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
615782|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
615783|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
615784|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
615785|NCT00483119|E2|Reported Event|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
615786|NCT00483119|E1|Reported Event|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
615787|NCT00483041|B3|Baseline|Total|Total of all reporting groups
615788|NCT00483041|B2|Baseline|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615789|NCT00483041|B1|Baseline|PLACEBO|Placebo administered as a single intravenous dose
615790|NCT00483041|P2|Participant Flow|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615791|NCT00483041|P1|Participant Flow|PLACEBO|Placebo administered as a single intravenous dose
615792|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615793|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615794|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615795|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615796|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615797|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615798|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615799|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615800|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615801|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615802|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615803|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615804|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615805|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615806|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615807|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615808|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615809|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615810|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615811|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615812|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615813|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615814|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615815|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615816|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615817|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
615818|NCT00483041|E2|Reported Event|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
615819|NCT00483041|E1|Reported Event|PLACEBO|Placebo administered as a single intravenous dose
615820|NCT00483002|B1|Baseline|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
615821|NCT00483002|P1|Participant Flow|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
615822|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
615823|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
615824|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
615825|NCT00483002|E1|Reported Event|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
615826|NCT00482911|B3|Baseline|Total|Total of all reporting groups
615827|NCT00482911|B2|Baseline|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615828|NCT00482911|B1|Baseline|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615829|NCT00482911|P2|Participant Flow|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615830|NCT00482911|P1|Participant Flow|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615831|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615832|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615833|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615834|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615835|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615836|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615837|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615838|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615839|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615840|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615891|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615973|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615841|NCT00482911|E2|Reported Event|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
615842|NCT00482911|E1|Reported Event|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
615843|NCT00482729|B3|Baseline|Total|Total of all reporting groups
615844|NCT00482729|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615845|NCT00482729|B1|Baseline|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615846|NCT00482729|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615847|NCT00482729|P1|Participant Flow|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615848|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615849|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615850|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615851|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615852|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615853|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615854|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615855|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615856|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615857|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615858|NCT00482729|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615859|NCT00482729|E1|Reported Event|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
615860|NCT00482703|B3|Baseline|Total|Total of all reporting groups
615861|NCT00482703|B2|Baseline|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
615862|NCT00482703|B1|Baseline|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
615863|NCT00482703|P2|Participant Flow|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
615864|NCT00482703|P1|Participant Flow|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
615865|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615866|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615867|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615868|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615869|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615870|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615871|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615872|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615873|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615874|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615875|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615876|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615877|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615878|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615879|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615880|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615881|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615882|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615883|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615884|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615885|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615886|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615887|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615888|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615889|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615890|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615930|NCT00482612|B5|Baseline|Total|Total of all reporting groups
615892|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615893|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615894|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615895|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615896|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615897|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615898|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615899|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615900|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615901|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
615902|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615903|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615904|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
615905|NCT00482703|E3|Reported Event|Total|
615906|NCT00482703|E2|Reported Event|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
615907|NCT00482703|E1|Reported Event|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
615908|NCT00482677|B3|Baseline|Total|Total of all reporting groups
615909|NCT00482677|B2|Baseline|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
615910|NCT00482677|B1|Baseline|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
615911|NCT00482677|P2|Participant Flow|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
615912|NCT00482677|P1|Participant Flow|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
615913|NCT00482677|O2|Outcome|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
615914|NCT00482677|O1|Outcome|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
615931|NCT00482612|B4|Baseline|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
615974|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615915|NCT00482677|O2|Outcome|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
615916|NCT00482677|O1|Outcome|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
615917|NCT00482677|O2|Outcome|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
615918|NCT00482677|O1|Outcome|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
615919|NCT00482677|E2|Reported Event|Radiation|"Short course radiation alone~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study~Radiation: Short course radiotherapy"
615920|NCT00482677|E1|Reported Event|Temozolomide|"Temozolomide and short course radiation~temozolomide: Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.~DNA methylation analysis: A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms~quality-of-life assessment: prior to randomization until end of study"
615921|NCT00482625|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615922|NCT00482625|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615923|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615924|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615925|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615926|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615927|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615928|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615929|NCT00482625|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
615932|NCT00482612|B3|Baseline|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
615933|NCT00482612|B2|Baseline|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
615934|NCT00482612|B1|Baseline|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
615935|NCT00482612|P4|Participant Flow|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
615936|NCT00482612|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
615937|NCT00482612|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
615938|NCT00482612|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
615939|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
615940|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615941|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
615942|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615943|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
615944|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615945|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
615946|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615947|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
615948|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615949|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
615950|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615951|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
615952|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615953|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
615954|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615955|NCT00482612|E8|Reported Event|Placebo Follow-up|After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
615956|NCT00482612|E7|Reported Event|Esmirtazapine 4.5 mg Follow-up|After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
615957|NCT00482612|E6|Reported Event|Esmirtazapine 3.0 mg Folow-up|After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
615958|NCT00482612|E5|Reported Event|Esmirtazapine 1.5 mg Follow-up|After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
615959|NCT00482612|E4|Reported Event|Placebo In-treatment|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
615960|NCT00482612|E3|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615961|NCT00482612|E2|Reported Event|Esmirtazapine 3.0 mg In-Treatment|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
615962|NCT00482612|E1|Reported Event|Esmirtazapine 1.5 mg In-treatment|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
615963|NCT00482547|B3|Baseline|Total|Total of all reporting groups
615964|NCT00482547|B2|Baseline|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615965|NCT00482547|B1|Baseline|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615966|NCT00482547|P2|Participant Flow|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615967|NCT00482547|P1|Participant Flow|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615968|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615969|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615970|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615971|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615972|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
621604|NCT00467844|O1|Outcome|GTx-024 1 mg|
615975|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615976|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615977|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615978|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615979|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615980|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615981|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615982|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615983|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615984|NCT00482547|E2|Reported Event|Silicone-coated Catheter|silicone elastomer-coated latex catheter
615985|NCT00482547|E1|Reported Event|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
615986|NCT00482391|B1|Baseline|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
615987|NCT00482391|P1|Participant Flow|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
615988|NCT00482391|O1|Outcome|Dose-dense Adjuvant/ Neoadjuvant Chemotherapy Regimen|
615989|NCT00482391|O1|Outcome|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
615990|NCT00482391|E1|Reported Event|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
615991|NCT00482274|B1|Baseline|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615992|NCT00482274|P1|Participant Flow|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615993|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615994|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615995|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615996|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615997|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615998|NCT00482274|E1|Reported Event|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
615999|NCT00482170|B3|Baseline|Total|Total of all reporting groups
616000|NCT00482170|B2|Baseline|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616001|NCT00482170|B1|Baseline|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616002|NCT00482170|P2|Participant Flow|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
616003|NCT00482170|P1|Participant Flow|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
616004|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
621605|NCT00467844|E3|Reported Event|3 mg of Placebo|Placebo
616005|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616006|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616007|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616008|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616009|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616010|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616011|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616012|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616013|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616014|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616015|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616016|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616017|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616018|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616019|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616020|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616021|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616022|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616023|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616024|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616025|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616026|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616027|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616028|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616029|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616030|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616031|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616032|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616033|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616034|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616035|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616036|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616037|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616038|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616039|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616040|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616041|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616042|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616043|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616044|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616045|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616046|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616047|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616048|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616049|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616050|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616051|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616052|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616053|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616054|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616055|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616056|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616057|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
621606|NCT00467844|E2|Reported Event|GTx-024|3 mg
616058|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616059|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616060|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616061|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616062|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616063|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616064|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616065|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616066|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616067|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616068|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616069|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616070|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616071|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616072|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616073|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616074|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616075|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616076|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616077|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616078|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616079|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616080|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616081|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616082|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616083|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616084|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616085|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616086|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616087|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616088|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616089|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616090|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616091|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616092|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616093|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616094|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616095|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616096|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616097|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616098|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616099|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616100|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616101|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616102|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616103|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616104|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616105|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616106|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616107|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616108|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616109|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616110|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
621607|NCT00467844|E1|Reported Event|GTx -024|1 mg
616111|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616112|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616113|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616114|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616115|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616116|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616117|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616118|NCT00482170|E2|Reported Event|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
616119|NCT00482170|E1|Reported Event|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
616120|NCT00482053|B1|Baseline|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616121|NCT00482053|P1|Participant Flow|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616122|NCT00482053|O1|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616123|NCT00482053|O1|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616124|NCT00482053|O1|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616125|NCT00482053|O1|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
617085|NCT00479037|E2|Reported Event|Strontium Ranelate|One sachet (2 g) per day, suspended in water
616126|NCT00482053|O1|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616127|NCT00482053|O1|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616128|NCT00482053|O1|Outcome|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616129|NCT00482053|E1|Reported Event|Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL|"Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).~Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).~Subject’s participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone."
616130|NCT00482014|B5|Baseline|Total|Total of all reporting groups
616131|NCT00482014|B4|Baseline|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616132|NCT00482014|B3|Baseline|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616133|NCT00482014|B2|Baseline|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616134|NCT00482014|B1|Baseline|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616135|NCT00482014|P4|Participant Flow|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616136|NCT00482014|P3|Participant Flow|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616137|NCT00482014|P2|Participant Flow|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616451|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616138|NCT00482014|P1|Participant Flow|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616139|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616140|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616141|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616142|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616143|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616144|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616145|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616146|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616147|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616148|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616149|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616150|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616151|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616152|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616172|NCT00481871|B4|Baseline|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
616153|NCT00482014|O1|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616154|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616155|NCT00482014|E4|Reported Event|Phase 2: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616156|NCT00482014|E3|Reported Event|Phase 2: Pemetrexed + Carboplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616157|NCT00482014|E2|Reported Event|Phase 1: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
616158|NCT00482014|E1|Reported Event|Phase 1: Pemetrexed + Carboplatin|"500 milligrams/meter squared (mg/m²) pemetrexed (pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
616159|NCT00481988|B3|Baseline|Total|Total of all reporting groups
616160|NCT00481988|B2|Baseline|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
616161|NCT00481988|B1|Baseline|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
616162|NCT00481988|P2|Participant Flow|Sham Iomed II Phoresor Transcranial Direct Current Stimulation|The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
616163|NCT00481988|P1|Participant Flow|Iomed II Phoresor Transcranial Direct Current Stimulation|The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.
616164|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
616165|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
616166|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
616167|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
616168|NCT00481988|E2|Reported Event|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
616169|NCT00481988|E1|Reported Event|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
616170|NCT00481871|B6|Baseline|Total|Total of all reporting groups
616171|NCT00481871|B5|Baseline|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
616253|NCT00481676|B2|Baseline|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616173|NCT00481871|B3|Baseline|Phase 1 - Group C|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
616174|NCT00481871|B2|Baseline|Phase 1 - Group B|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
616175|NCT00481871|B1|Baseline|Phase 1 - Group A|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
616176|NCT00481871|P5|Participant Flow|Phase 2 Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
616177|NCT00481871|P4|Participant Flow|Phase 2 Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
616178|NCT00481871|P3|Participant Flow|Phase 1 Group C - Dose Finding|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
616179|NCT00481871|P2|Participant Flow|Phase 1 Group B - Dose Finding|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
616180|NCT00481871|P1|Participant Flow|Phase 1 Group A - Dose Finding|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
616181|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
616182|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
616183|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
616184|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
616185|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
616186|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
616187|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
616188|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
616189|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
616190|NCT00481871|E3|Reported Event|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
616191|NCT00481871|E2|Reported Event|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
616192|NCT00481871|E1|Reported Event|Phase 1|Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
616193|NCT00481845|B3|Baseline|Total|Total of all reporting groups
616194|NCT00481845|B2|Baseline|Anastrozole|Anastrozole as neoadjuvant therapy
616195|NCT00481845|B1|Baseline|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
616196|NCT00481845|P2|Participant Flow|Anastrozole|Anastrozole as neoadjuvant therapy
616197|NCT00481845|P1|Participant Flow|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
616198|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
616199|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
616200|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
616201|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
616202|NCT00481845|E2|Reported Event|Anastrozole|Anastrozole as neoadjuvant therapy
616203|NCT00481845|E1|Reported Event|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
616227|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616615|NCT00480493|B2|Baseline|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
616204|NCT00481832|B1|Baseline|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616205|NCT00481832|P1|Participant Flow|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616206|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616207|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616208|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616209|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616210|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616211|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616228|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616212|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616213|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616214|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616215|NCT00481832|O1|Outcome|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616216|NCT00481832|E1|Reported Event|T & B Cell Mobilization Auto & Allo HCT|A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
616217|NCT00481767|B3|Baseline|Total|Total of all reporting groups
616218|NCT00481767|B2|Baseline|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616219|NCT00481767|B1|Baseline|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616220|NCT00481767|P2|Participant Flow|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616221|NCT00481767|P1|Participant Flow|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616222|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616223|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616224|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616225|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616226|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616229|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616230|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616231|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616232|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616233|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616234|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616235|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616236|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616237|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616238|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616239|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616240|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616241|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616242|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616243|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616244|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616245|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616246|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616247|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616248|NCT00481767|O2|Outcome|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616249|NCT00481767|O1|Outcome|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616250|NCT00481767|E2|Reported Event|Placebo Group|Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616251|NCT00481767|E1|Reported Event|Cervarix Group|Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
616252|NCT00481676|B3|Baseline|Total|Total of all reporting groups
616254|NCT00481676|B1|Baseline|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616255|NCT00481676|P2|Participant Flow|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616256|NCT00481676|P1|Participant Flow|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616257|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616258|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616259|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616260|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616261|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616262|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616263|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616264|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616265|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616266|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616267|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616268|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616269|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616270|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616271|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616272|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616273|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616274|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616275|NCT00481676|E2|Reported Event|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616276|NCT00481676|E1|Reported Event|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
616277|NCT00481507|B3|Baseline|Total|Total of all reporting groups
616278|NCT00481507|B2|Baseline|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
616279|NCT00481507|B1|Baseline|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
616280|NCT00481507|P2|Participant Flow|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
616281|NCT00481507|P1|Participant Flow|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
626820|NCT00455429|B5|Baseline|Total|Total of all reporting groups
616282|NCT00481507|O2|Outcome|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
616283|NCT00481507|O1|Outcome|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
616284|NCT00481507|E2|Reported Event|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
616285|NCT00481507|E1|Reported Event|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
616286|NCT00481351|B3|Baseline|Total|Total of all reporting groups
616287|NCT00481351|B2|Baseline|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616288|NCT00481351|B1|Baseline|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616289|NCT00481351|P2|Participant Flow|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616290|NCT00481351|P1|Participant Flow|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616291|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616292|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616293|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616294|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616295|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616296|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616297|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616298|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616299|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616300|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616301|NCT00481351|E2|Reported Event|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
616302|NCT00481351|E1|Reported Event|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
616303|NCT00481247|B3|Baseline|Total|Total of all reporting groups
616304|NCT00481247|B2|Baseline|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616305|NCT00481247|B1|Baseline|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616306|NCT00481247|P2|Participant Flow|Imatinib|Tablets, oral, imatinib 400mg once daily (QD)
616307|NCT00481247|P1|Participant Flow|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616308|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616309|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616310|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616311|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616312|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616313|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616314|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616315|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616316|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616317|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616318|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616319|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616320|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616321|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616322|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616323|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616324|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616325|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616326|NCT00481247|E2|Reported Event|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
616327|NCT00481247|E1|Reported Event|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
616328|NCT00481195|B3|Baseline|Total|Total of all reporting groups
616338|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616329|NCT00481195|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616330|NCT00481195|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616331|NCT00481195|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616332|NCT00481195|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616333|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616334|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616335|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616336|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616337|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616434|NCT00481065|B3|Baseline|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616616|NCT00480493|B1|Baseline|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
616339|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616340|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616341|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616342|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616343|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616344|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616345|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616346|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616347|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616435|NCT00481065|B2|Baseline|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616633|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616348|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616349|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616350|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616351|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616352|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616353|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616354|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616355|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616356|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616436|NCT00481065|B1|Baseline|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616437|NCT00481065|P8|Participant Flow|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616357|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616358|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616359|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616360|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616361|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616362|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616363|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616364|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616365|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616438|NCT00481065|P7|Participant Flow|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616439|NCT00481065|P6|Participant Flow|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616366|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616367|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616368|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616369|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616370|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616371|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616372|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616373|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616374|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616440|NCT00481065|P5|Participant Flow|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616441|NCT00481065|P4|Participant Flow|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616617|NCT00480493|P2|Participant Flow|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
616375|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616376|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616377|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616378|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616379|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616380|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616381|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616382|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616383|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616442|NCT00481065|P3|Participant Flow|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616618|NCT00480493|P1|Participant Flow|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
616384|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616385|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616386|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616387|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616388|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616389|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616390|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616391|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616392|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616443|NCT00481065|P2|Participant Flow|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616449|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616393|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616394|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616395|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616396|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616397|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616398|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616399|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616400|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616401|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616444|NCT00481065|P1|Participant Flow|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616445|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616402|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616403|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616404|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616405|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616406|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616407|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616408|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616409|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616410|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616446|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616447|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616450|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616411|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616412|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616413|NCT00481195|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
616414|NCT00481195|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
616415|NCT00481078|B3|Baseline|Total|Total of all reporting groups
616416|NCT00481078|B2|Baseline|Arm 2|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
616417|NCT00481078|B1|Baseline|Arm 1|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
616418|NCT00481078|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
616419|NCT00481078|P1|Participant Flow|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
616420|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
616421|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
616422|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
616423|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
616424|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
616425|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
616426|NCT00481078|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
616427|NCT00481078|E1|Reported Event|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
616428|NCT00481065|B9|Baseline|Total|Total of all reporting groups
616429|NCT00481065|B8|Baseline|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616430|NCT00481065|B7|Baseline|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616431|NCT00481065|B6|Baseline|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616432|NCT00481065|B5|Baseline|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616433|NCT00481065|B4|Baseline|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616448|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616452|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616453|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616454|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616455|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616456|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616457|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616458|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616459|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616460|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616461|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616462|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616463|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616464|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616465|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616466|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616467|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616468|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616469|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616470|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616471|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616472|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616473|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616474|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616475|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616476|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616477|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616478|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616479|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616480|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616481|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616482|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616483|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616484|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616485|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616486|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616487|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616488|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616489|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616490|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616491|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616492|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616493|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616494|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616495|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616496|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616497|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616498|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616499|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616500|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616501|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616502|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616503|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616504|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616505|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616506|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616507|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616508|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616509|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616510|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616511|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616512|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616513|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616514|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616515|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616516|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616517|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616518|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616619|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
616519|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616520|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616521|NCT00481065|E8|Reported Event|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616522|NCT00481065|E7|Reported Event|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616523|NCT00481065|E6|Reported Event|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616524|NCT00481065|E5|Reported Event|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
616525|NCT00481065|E4|Reported Event|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616526|NCT00481065|E3|Reported Event|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616527|NCT00481065|E2|Reported Event|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616528|NCT00481065|E1|Reported Event|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
616529|NCT00480987|B1|Baseline|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
616530|NCT00480987|P1|Participant Flow|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
616531|NCT00480987|O1|Outcome|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
616532|NCT00480987|E1|Reported Event|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
616533|NCT00480857|B1|Baseline|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616534|NCT00480857|P1|Participant Flow|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616535|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616536|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616537|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616538|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616539|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616540|NCT00480857|E1|Reported Event|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
616541|NCT00480779|B3|Baseline|Total|Total of all reporting groups
616542|NCT00480779|B2|Baseline|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
616543|NCT00480779|B1|Baseline|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
616544|NCT00480779|P2|Participant Flow|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
616620|NCT00480493|O1|Outcome|Parent Contact Control Arm|
616621|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
616545|NCT00480779|P1|Participant Flow|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
616546|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616547|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616548|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616549|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616550|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616551|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616552|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616622|NCT00480493|O1|Outcome|Parent Contact Control Arm|
629180|NCT00450073|B1|Baseline|Vitamin D3|vitamin D3 50,000 IU weekly
616553|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616554|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616555|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616556|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616557|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616558|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616559|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616623|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
616624|NCT00480493|O1|Outcome|Parent Contact Control Arm|Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.
616625|NCT00480493|E2|Reported Event|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
616626|NCT00480493|E1|Reported Event|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
616560|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616561|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616562|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616563|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616564|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616565|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616566|NCT00480779|E2|Reported Event|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD:The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
616627|NCT00480324|B3|Baseline|Total|Total of all reporting groups
616628|NCT00480324|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616629|NCT00480324|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616630|NCT00480324|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616631|NCT00480324|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616632|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616567|NCT00480779|E1|Reported Event|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
616568|NCT00480740|B4|Baseline|Total|Total of all reporting groups
616569|NCT00480740|B3|Baseline|Fontan Physiology|
616570|NCT00480740|B2|Baseline|Cardiac Transplant|
616571|NCT00480740|B1|Baseline|Normal Physiology|
616572|NCT00480740|P3|Participant Flow|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
616573|NCT00480740|P2|Participant Flow|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
616574|NCT00480740|P1|Participant Flow|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
616575|NCT00480740|O3|Outcome|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
616576|NCT00480740|O2|Outcome|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
616577|NCT00480740|O1|Outcome|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
616578|NCT00480740|E3|Reported Event|Normal Physiology|"control group~Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization"
616579|NCT00480740|E2|Reported Event|Fontan Procedure|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
616580|NCT00480740|E1|Reported Event|Cardiac Transplant|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
616581|NCT00480636|B1|Baseline|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616582|NCT00480636|P1|Participant Flow|Dalteparin|Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616583|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616584|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616585|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616586|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616587|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616588|NCT00480636|E1|Reported Event|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
616589|NCT00480532|B5|Baseline|Total|Total of all reporting groups
616590|NCT00480532|B4|Baseline|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
616591|NCT00480532|B3|Baseline|Placebo (Prevention)|Placebo for prevention portion of the study
616592|NCT00480532|B2|Baseline|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
616593|NCT00480532|B1|Baseline|Placebo (Treatment)|Placebo (for treatment portion of the study)
616594|NCT00480532|P4|Participant Flow|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
616595|NCT00480532|P3|Participant Flow|Placebo (Prevention)|Placebo for prevention portion of the study
616596|NCT00480532|P2|Participant Flow|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
616597|NCT00480532|P1|Participant Flow|Placebo (Treatment)|Placebo (for treatment portion of the study)
616598|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
616599|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
616600|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
616601|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
616602|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
616603|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
616604|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
616605|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
616606|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
616607|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
616608|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
616609|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
616610|NCT00480532|E4|Reported Event|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
616611|NCT00480532|E3|Reported Event|Placebo (Prevention)|Placebo for prevention portion of the study
616612|NCT00480532|E2|Reported Event|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
616613|NCT00480532|E1|Reported Event|Placebo (Treatment)|Placebo (for treatment portion of the study)
616614|NCT00480493|B3|Baseline|Total|Total of all reporting groups
616634|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616635|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616636|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616637|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616638|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616639|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616640|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616641|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616642|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616643|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616644|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616645|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616646|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616647|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616648|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616649|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616650|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616651|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616652|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616653|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616654|NCT00480324|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
616655|NCT00480324|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
616656|NCT00479882|B5|Baseline|Total|Total of all reporting groups
616657|NCT00479882|B4|Baseline|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
616658|NCT00479882|B3|Baseline|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
616659|NCT00479882|B2|Baseline|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
616660|NCT00479882|B1|Baseline|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
616661|NCT00479882|P4|Participant Flow|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
616662|NCT00479882|P3|Participant Flow|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
616663|NCT00479882|P2|Participant Flow|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
616664|NCT00479882|P1|Participant Flow|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
616665|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
616666|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
616667|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
616668|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
616669|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
616670|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
616671|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
616672|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
617086|NCT00479037|E1|Reported Event|PTH(1-84)|Once daily subcutaneous injection
616673|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616674|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616675|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616676|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616677|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616678|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616679|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616680|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616681|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616682|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616683|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616684|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616685|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616686|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616687|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616688|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616689|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616690|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616691|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616692|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616693|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616694|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616695|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616696|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616697|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616698|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616699|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616700|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616701|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616702|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616703|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616704|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616705|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616706|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616707|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616708|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616709|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616710|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616711|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616712|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616713|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616714|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616822|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616715|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616716|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616717|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616718|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616719|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616720|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616721|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616722|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616723|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616724|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616725|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616726|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616727|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616728|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616729|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616730|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616731|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616732|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616733|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616734|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616735|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616736|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616737|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616738|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616739|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616740|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616741|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616742|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616743|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616744|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616745|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616746|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616747|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616748|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616749|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616750|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616751|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616752|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616753|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616754|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616755|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616756|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616757|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616758|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616759|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616760|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616761|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616762|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616763|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616764|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616765|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616766|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616767|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616768|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616769|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616770|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616771|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
616772|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616773|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616774|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
616775|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
616776|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616777|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
616778|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
616779|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
616780|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
616781|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
616782|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
616783|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
616784|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
616785|NCT00479882|E8|Reported Event|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
616786|NCT00479882|E7|Reported Event|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
616787|NCT00479882|E6|Reported Event|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
616788|NCT00479882|E5|Reported Event|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
616789|NCT00479882|E4|Reported Event|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
616790|NCT00479882|E3|Reported Event|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III
616791|NCT00479882|E2|Reported Event|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II
616792|NCT00479882|E1|Reported Event|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
616793|NCT00479856|B1|Baseline|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616794|NCT00479856|P1|Participant Flow|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616795|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616796|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616797|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616798|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616799|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616800|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616801|NCT00479856|E1|Reported Event|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
616802|NCT00479765|B1|Baseline|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
616803|NCT00479765|P1|Participant Flow|OncoGel|"OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
616804|NCT00479765|O1|Outcome|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
616805|NCT00479765|E1|Reported Event|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
616806|NCT00479713|B3|Baseline|Total|Total of all reporting groups
616807|NCT00479713|B2|Baseline|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616808|NCT00479713|B1|Baseline|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616809|NCT00479713|P2|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616810|NCT00479713|P1|Participant Flow|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616811|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616812|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616813|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616814|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616815|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616816|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616817|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616818|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616819|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616820|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616821|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616941|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616823|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616824|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616825|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616826|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616827|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616828|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616829|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616830|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616831|NCT00479713|E2|Reported Event|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
616832|NCT00479713|E1|Reported Event|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
616833|NCT00479674|B1|Baseline|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616834|NCT00479674|P1|Participant Flow|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616835|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616836|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616837|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616838|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616839|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616840|NCT00479674|E1|Reported Event|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
616841|NCT00479557|B8|Baseline|Total|Total of all reporting groups
616842|NCT00479557|B7|Baseline|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616843|NCT00479557|B6|Baseline|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616844|NCT00479557|B5|Baseline|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616845|NCT00479557|B4|Baseline|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616846|NCT00479557|B3|Baseline|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616847|NCT00479557|B2|Baseline|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616848|NCT00479557|B1|Baseline|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616849|NCT00479557|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616850|NCT00479557|P6|Participant Flow|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616851|NCT00479557|P5|Participant Flow|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616852|NCT00479557|P4|Participant Flow|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616853|NCT00479557|P3|Participant Flow|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616854|NCT00479557|P2|Participant Flow|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616855|NCT00479557|P1|Participant Flow|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616856|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616857|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616858|NCT00479557|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616859|NCT00479557|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616860|NCT00479557|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616861|NCT00479557|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616862|NCT00479557|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616863|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616864|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616865|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616866|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616867|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616868|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616869|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616870|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616871|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616872|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616873|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616874|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616875|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616942|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616876|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616877|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616878|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616879|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616880|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616881|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616882|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616883|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616884|NCT00479557|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616885|NCT00479557|E6|Reported Event|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616886|NCT00479557|E5|Reported Event|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616887|NCT00479557|E4|Reported Event|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616888|NCT00479557|E3|Reported Event|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616889|NCT00479557|E2|Reported Event|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616890|NCT00479557|E1|Reported Event|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
616891|NCT00479466|B7|Baseline|Total|Total of all reporting groups
616892|NCT00479466|B6|Baseline|Metformin HCL|
616893|NCT00479466|B5|Baseline|MK0893 80 mg|
616894|NCT00479466|B4|Baseline|MK0893 60 mg|
616895|NCT00479466|B3|Baseline|MK0893 40 mg|
616896|NCT00479466|B2|Baseline|MK0893 20 mg|
616897|NCT00479466|B1|Baseline|Placebo|
616898|NCT00479466|P6|Participant Flow|Metformin HCL|
616899|NCT00479466|P5|Participant Flow|MK0893 80 mg|
616900|NCT00479466|P4|Participant Flow|MK0893 60 mg|
616901|NCT00479466|P3|Participant Flow|MK0893 40 mg|
616902|NCT00479466|P2|Participant Flow|MK0893 20 mg|
616903|NCT00479466|P1|Participant Flow|Placebo|
616904|NCT00479466|O6|Outcome|Metformin HCL|
616905|NCT00479466|O5|Outcome|MK0893 80 mg|
616906|NCT00479466|O4|Outcome|MK0893 60 mg|
616907|NCT00479466|O3|Outcome|MK0893 40 mg|
616908|NCT00479466|O2|Outcome|MK0893 20 mg|
616909|NCT00479466|O1|Outcome|Placebo|
616910|NCT00479466|O6|Outcome|Metformin HCL|
616911|NCT00479466|O5|Outcome|MK0893 80 mg|
616912|NCT00479466|O4|Outcome|MK0893 60 mg|
616913|NCT00479466|O3|Outcome|MK0893 40 mg|
616914|NCT00479466|O2|Outcome|MK0893 20 mg|
616915|NCT00479466|O1|Outcome|Placebo|
616916|NCT00479466|O6|Outcome|Metformin HCL|
616917|NCT00479466|O5|Outcome|MK0893 80 mg|
616918|NCT00479466|O4|Outcome|MK0893 60 mg|
616919|NCT00479466|O3|Outcome|MK0893 40 mg|
616920|NCT00479466|O2|Outcome|MK0893 20 mg|
616921|NCT00479466|O1|Outcome|Placebo|
616922|NCT00479466|E6|Reported Event|Metformin HCL|
616923|NCT00479466|E5|Reported Event|MK0893 80 mg|
616924|NCT00479466|E4|Reported Event|MK0893 60 mg|
616925|NCT00479466|E3|Reported Event|MK0893 40 mg|
616926|NCT00479466|E2|Reported Event|MK0893 20 mg|
616927|NCT00479466|E1|Reported Event|Placebo|
616928|NCT00479401|B4|Baseline|Total|Total of all reporting groups
616929|NCT00479401|B3|Baseline|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616930|NCT00479401|B2|Baseline|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616931|NCT00479401|B1|Baseline|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616932|NCT00479401|P3|Participant Flow|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616933|NCT00479401|P2|Participant Flow|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616934|NCT00479401|P1|Participant Flow|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616935|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616936|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616937|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616938|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616939|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616940|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616943|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616944|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616945|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616946|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616947|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616948|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616949|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616950|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616951|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616952|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616953|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616954|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616955|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616956|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616957|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616958|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616959|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616960|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616961|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616962|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616963|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616964|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616965|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616966|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616967|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616968|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616969|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616970|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616971|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616972|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616973|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616974|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616975|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616976|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616977|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616978|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616979|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616980|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616981|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616982|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616983|NCT00479401|E3|Reported Event|Placebo|Placebo to PPX ER once and to PPX IR three times a day
616984|NCT00479401|E2|Reported Event|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
616985|NCT00479401|E1|Reported Event|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
616986|NCT00479388|B3|Baseline|Total|Total of all reporting groups
616987|NCT00479388|B2|Baseline|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
616988|NCT00479388|B1|Baseline|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
616989|NCT00479388|P2|Participant Flow|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
616990|NCT00479388|P1|Participant Flow|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
616991|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
616992|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
616993|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
616994|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
616995|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
617079|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
617080|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
616996|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
616997|NCT00479388|E2|Reported Event|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
616998|NCT00479388|E1|Reported Event|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
616999|NCT00479336|B5|Baseline|Total|Total of all reporting groups
617000|NCT00479336|B4|Baseline|OPC-41061 30 mg|30 mg, 1 tablet a day
617001|NCT00479336|B3|Baseline|OPC-41061 15 mg|15 mg, 1 tablet a day
617002|NCT00479336|B2|Baseline|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
617003|NCT00479336|B1|Baseline|Placebo|Placebo, 1 tablet a day
617004|NCT00479336|P4|Participant Flow|OPC-41061 30 mg|30 mg, 1 tablet a day
617005|NCT00479336|P3|Participant Flow|OPC-41061 15 mg|15 mg, 1 tablet a day
617006|NCT00479336|P2|Participant Flow|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
617007|NCT00479336|P1|Participant Flow|Placebo|Placebo, 1 tablet a day
617008|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
617009|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
617010|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
617011|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
617012|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
617013|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
617014|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
617015|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
617016|NCT00479336|E4|Reported Event|OPC-41061 30 mg|30 mg, 1 tablet a day
617017|NCT00479336|E3|Reported Event|OPC-41061 15 mg|15 mg, 1 tablet a day
617018|NCT00479336|E2|Reported Event|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
617019|NCT00479336|E1|Reported Event|Placebo|Placebo, 1 tablet a day
617020|NCT00479258|B3|Baseline|Total|Total of all reporting groups
617021|NCT00479258|B2|Baseline|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
617022|NCT00479258|B1|Baseline|Inhaled Insulin (Exubera)|No subjects received study medication.
617023|NCT00479258|P2|Participant Flow|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
617024|NCT00479258|P1|Participant Flow|Inhaled Insulin (Exubera)|No subjects received study medication.
617025|NCT00479258|O2|Outcome|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
617026|NCT00479258|O1|Outcome|Inhaled Insulin (Exubera)|No subjects received study medication.
617027|NCT00479232|B3|Baseline|Total|Total of all reporting groups
617028|NCT00479232|B2|Baseline|Vorinostat + Decitabine, Sequential|(sequential) Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
617029|NCT00479232|B1|Baseline|Vorinostat + Decitabine, Concurrent|(concurrent) Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
617030|NCT00479232|P6|Participant Flow|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617031|NCT00479232|P5|Participant Flow|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617032|NCT00479232|P4|Participant Flow|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617033|NCT00479232|P3|Participant Flow|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617034|NCT00479232|P2|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617035|NCT00479232|P1|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617036|NCT00479232|O2|Outcome|Untreated AML or Intermediate, Sequential|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~sequentially."
617037|NCT00479232|O1|Outcome|Untreated AML or Intermediate, Concurrent|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~concurrently."
617038|NCT00479232|O2|Outcome|Refractory or Relapsed AML, Sequential|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine sequentially.
617039|NCT00479232|O1|Outcome|Refractory or Relapsed AML, Concurrent|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine concurrently.
617040|NCT00479232|O6|Outcome|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617041|NCT00479232|O5|Outcome|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617081|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
617042|NCT00479232|O4|Outcome|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617043|NCT00479232|O3|Outcome|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617044|NCT00479232|O2|Outcome|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617045|NCT00479232|O1|Outcome|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617046|NCT00479232|E6|Reported Event|Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(sequential) orinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617047|NCT00479232|E5|Reported Event|Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617048|NCT00479232|E4|Reported Event|Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617049|NCT00479232|E3|Reported Event|Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617050|NCT00479232|E2|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617051|NCT00479232|E1|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
617052|NCT00479154|B3|Baseline|Total|Total of all reporting groups
617053|NCT00479154|B2|Baseline|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
617054|NCT00479154|B1|Baseline|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
617055|NCT00479154|P2|Participant Flow|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
617056|NCT00479154|P1|Participant Flow|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
617057|NCT00479154|O2|Outcome|Botulinum Toxin|Injection of Botulinum Toxin (90 mU per leg).
617058|NCT00479154|O1|Outcome|Placebo|Injection into set of leg muscles with Placebo.
617059|NCT00479154|E2|Reported Event|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
617060|NCT00479154|E1|Reported Event|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
617061|NCT00479089|B3|Baseline|Total|Total of all reporting groups
617062|NCT00479089|B2|Baseline|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
617063|NCT00479089|B1|Baseline|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
617064|NCT00479089|P2|Participant Flow|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
617065|NCT00479089|P1|Participant Flow|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
617066|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
617067|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
617068|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
617069|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
617070|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
617071|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
617072|NCT00479089|E2|Reported Event|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
617073|NCT00479089|E1|Reported Event|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
617074|NCT00479037|B3|Baseline|Total|Total of all reporting groups
617075|NCT00479037|B2|Baseline|Strontium Ranelate|One sachet (2 g) per day, suspended in water
617076|NCT00479037|B1|Baseline|PTH(1-84)|Once daily subcutaneous injection
617077|NCT00479037|P2|Participant Flow|Strontium Ranelate|One sachet (2 g) per day, suspended in water
617078|NCT00479037|P1|Participant Flow|PTH(1-84)|Once daily subcutaneous injection
617087|NCT00478933|B1|Baseline|ICD Therapy, Blood Sampling|"Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.~Blood sampling: Blood sampling for genetic analysis on pre-specified SNPs"
617088|NCT00478933|P1|Participant Flow|ICD Therapy, Blood Sampling|"Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.~Blood sampling: Blood sampling for genetic analysis of the pre-identified SNPs"
617089|NCT00478933|O3|Outcome|c.825C>T TT Genotype|Patients in this group have two copies of the minor (A) allele for the c.825C>T single nucleotide polymorphism (SNP) in the GNB3 gene
617090|NCT00478933|O2|Outcome|c.825C>T CT Genotype|Patients in this group have one copy of each allele (C and T) for the c.825C>T single nucleotide polymorphism (SNP) in the GNB3 gene
617091|NCT00478933|O1|Outcome|c.825C>T CC Genotype|Patients in this group have two copies of the major (G) allele for the c.825C>T CC single nucleotide polymorphism (SNP) in the GNB3 gene
617092|NCT00478933|O3|Outcome|c.-387G>A AA Genotype|Patients in this group have two copies of the minor (A) allele for the c.-387G>A single nucleotide polymorphism (SNP) in the GNAQ gene
617093|NCT00478933|O2|Outcome|c.-387G>A GA Genotype|Patients in this group have one copy of each allele (C and T) for the c.-387G>A single nucleotide polymorphism (SNP) in the GNAQ gene
617094|NCT00478933|O1|Outcome|c.-387G>A GG Genotype|Patients in this group have two copies of the major (G) allele for the c.-387G>A single nucleotide polymorphism (SNP) in the GNAQ gene
617095|NCT00478933|O3|Outcome|c.-382G>A AA Genotype|Patients in this group have two copies of the minor (A) allele for the c.-382G>A single nucleotide polymorphism (SNP) in the GNAQ gene
617096|NCT00478933|O2|Outcome|c.-382G>A GA Genotype|Patients in this group have one copy of each allele (C and T) for the c.-382G>A single nucleotide polymorphism (SNP) in the GNAQ gene
617097|NCT00478933|O1|Outcome|c.-382G>A GG Genotype|Patients in this group have two copies of the major (G) allele for the c.-382G>A single nucleotide polymorphism (SNP) in the GNAQ gene
617098|NCT00478933|O3|Outcome|GNAQ c.-909/-908GC>TT TT/TT Genotype|Patients in this group have two copies of the minor (TT) allele for the c.-909/-908GC>TT single nucleotide polymorphism (SNP) in the GNAQ gene
617099|NCT00478933|O2|Outcome|GNAQ c.-909/-908GC>TT GC/TT Genotype|Patients in this group have one copy of each allele (GC and TT) for the c.-909/-908GC>TT single nucleotide polymorphism (SNP) in the GNAS gene
617100|NCT00478933|O1|Outcome|GNAQ c.-909/-908GC>TT GC/GC Genotype|Patients in this group have two copies of the major (GC) allele for the c.-909/-908GC>TT single nucleotide polymorphism (SNP) in the GNAQ gene
617101|NCT00478933|O3|Outcome|c.2291C>T TT Genotype|Patients in this group have two copies of the minor (T) allele for the c.2291C>T single nucleotide polymorphism (SNP) in the GNAS gene
617102|NCT00478933|O2|Outcome|c.2291C>T CT Genotype|Patients in this group have one copy of each allele (C and T) for the c.2291C>T single nucleotide polymorphism (SNP) in the GNAS gene
617103|NCT00478933|O1|Outcome|c.2291C>T CC Genotype|Patients in this group have two copies of the major (C) allele for the c.2291C>T single nucleotide polymorphism (SNP) in the GNAS gene
617104|NCT00478933|O3|Outcome|c.393C>T TT Genotype|Patients in this group have two copies of the minor (T) allele for the c.2273C>T single nucleotide polymorphism (SNP) in the GNAS gene
617105|NCT00478933|O2|Outcome|c.2273C>T CT Genotype|Patients in this group have one copy of each (C and T) allele for the c.2273C>T single nucleotide polymorphism (SNP) in the GNAS gene
617106|NCT00478933|O1|Outcome|c.2273C>T CC Genotype|Patients in this group have two copies of the major (C) allele for the c.2273C>T single nucleotide polymorphism (SNP) in the GNAS gene
617107|NCT00478933|O3|Outcome|c.393C>T TT Genotype|Patients in this group have two copies of the minor (T) allele for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene
617108|NCT00478933|O2|Outcome|c.393C>T CT Genotype|Patients in this group have one copy of each allele (C and T) for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene
617109|NCT00478933|O1|Outcome|c.393C>T CC Genotype|Patients in this group have two copies of the major (C) allele for the c.393C>T single nucleotide polymorphism (SNP) in the GNAS gene
617110|NCT00478933|E1|Reported Event|ICD Therapy, Blood Sampling|"Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes.~Blood sampling: Blood sampling for genetic analysis on pre-identified SNPs"
617111|NCT00478881|B3|Baseline|Total|Total of all reporting groups
617112|NCT00478881|B2|Baseline|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617113|NCT00478881|B1|Baseline|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617114|NCT00478881|P2|Participant Flow|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617115|NCT00478881|P1|Participant Flow|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617116|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617117|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617118|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617119|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617120|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617121|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617122|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617123|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617124|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617125|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617126|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617127|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617128|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617129|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617130|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617131|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617132|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617133|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617134|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617135|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617136|NCT00478881|E2|Reported Event|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
617137|NCT00478881|E1|Reported Event|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
617138|NCT00478777|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
617139|NCT00478777|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
617140|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
617141|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
617142|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
617143|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
617144|NCT00478777|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
617145|NCT00478673|B1|Baseline|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
617146|NCT00478673|P1|Participant Flow|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
617147|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
617148|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
629277|NCT00449644|B5|Baseline|Total|Total of all reporting groups
617149|NCT00478673|E1|Reported Event|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
617150|NCT00478647|B1|Baseline|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617151|NCT00478647|P1|Participant Flow|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617152|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617153|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617154|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617155|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617156|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617157|NCT00478647|E1|Reported Event|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
617158|NCT00478608|B1|Baseline|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617159|NCT00478608|P1|Participant Flow|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617160|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617161|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617162|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617163|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617164|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617165|NCT00478608|E1|Reported Event|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
617166|NCT00478569|B1|Baseline|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
617167|NCT00478569|P1|Participant Flow|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
617168|NCT00478569|O5|Outcome|24 Months|
617169|NCT00478569|O4|Outcome|18 Months|
617170|NCT00478569|O3|Outcome|12 Months|
617171|NCT00478569|O2|Outcome|6 Months|
617172|NCT00478569|O1|Outcome|3 Months|
617173|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
617174|NCT00478569|O4|Outcome|24 Months|
617175|NCT00478569|O3|Outcome|18 Months|
617176|NCT00478569|O2|Outcome|12 Months|
617177|NCT00478569|O1|Outcome|3 Months|
617178|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
617179|NCT00478569|E1|Reported Event|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
617180|NCT00478556|B3|Baseline|Total|Total of all reporting groups
617181|NCT00478556|B2|Baseline|Omnipaque|Oral Omnipaque prior to CT
617182|NCT00478556|B1|Baseline|Gastroview|Oral Gastroview prior to CT
617183|NCT00478556|P2|Participant Flow|Omnipaque Group|Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).
617184|NCT00478556|P1|Participant Flow|Gastroview Group|Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT).
617185|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
617186|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
617187|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
617188|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
617189|NCT00478556|E2|Reported Event|Omnipaque|Oral Omnipaque prior to CT
617190|NCT00478556|E1|Reported Event|Gastroview|Oral Gastroview prior to CT
617191|NCT00478335|B3|Baseline|Total|Total of all reporting groups
617192|NCT00478335|B2|Baseline|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
617193|NCT00478335|B1|Baseline|Experimental First Then Standard|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily)."
617194|NCT00478335|P2|Participant Flow|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
617195|NCT00478335|P1|Participant Flow|Experimental First Then Standard|"Experimental phase: 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily)."
617390|NCT00477672|E3|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
617196|NCT00478335|O2|Outcome|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
617197|NCT00478335|O1|Outcome|Experimental First Then Standard|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~on subject weight"
617198|NCT00478335|E2|Reported Event|Standard First Then Experimental|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight)."
617199|NCT00478335|E1|Reported Event|Experimental First Then Standard|"4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).~Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily)."
617200|NCT00478257|B3|Baseline|Total|Total of all reporting groups
617201|NCT00478257|B2|Baseline|Effect of Red Light|effect of red light on fatigue in women with breast cancer
617202|NCT00478257|B1|Baseline|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
617203|NCT00478257|P2|Participant Flow|Effect of Red Light|effect of red light on fatigue in women with breast cancer
617204|NCT00478257|P1|Participant Flow|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
617205|NCT00478257|O2|Outcome|Effect of Red Light|effect of red light on fatigue in women with breast cancer
617206|NCT00478257|O1|Outcome|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
617207|NCT00478257|E2|Reported Event|Effect of Red Light|effect of red light on fatigue in women with breast cancer
617208|NCT00478257|E1|Reported Event|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
617209|NCT00478244|B1|Baseline|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
617210|NCT00478244|P1|Participant Flow|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
617211|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617212|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617213|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617214|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617215|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617216|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617217|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617218|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617219|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617220|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
617221|NCT00478244|E1|Reported Event|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
617222|NCT00478231|B1|Baseline|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617223|NCT00478231|P1|Participant Flow|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617224|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617225|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617226|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617227|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617228|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617229|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617230|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617231|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617232|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617233|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617234|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617235|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617236|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617237|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617238|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617239|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617240|NCT00478231|E1|Reported Event|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
617241|NCT00478218|B3|Baseline|Total|Total of all reporting groups
617242|NCT00478218|B2|Baseline|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617243|NCT00478218|B1|Baseline|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617244|NCT00478218|P2|Participant Flow|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617245|NCT00478218|P1|Participant Flow|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617246|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617247|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617248|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617249|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617250|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617251|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617252|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617253|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617254|NCT00478218|E2|Reported Event|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617255|NCT00478218|E1|Reported Event|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
617256|NCT00478205|B3|Baseline|Total|Total of all reporting groups
617257|NCT00478205|B2|Baseline|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
617391|NCT00477672|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
617258|NCT00478205|B1|Baseline|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
617259|NCT00478205|P2|Participant Flow|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
617260|NCT00478205|P1|Participant Flow|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
617261|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
617262|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
617263|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
617264|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
617265|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
617266|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
617267|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
617268|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
617269|NCT00478205|E2|Reported Event|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
617270|NCT00478205|E1|Reported Event|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
617271|NCT00478192|B4|Baseline|Total|Total of all reporting groups
617272|NCT00478192|B3|Baseline|Regimen 3 Placebo|
617273|NCT00478192|B2|Baseline|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617274|NCT00478192|B1|Baseline|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617275|NCT00478192|P3|Participant Flow|Regimen 3 Placebo|
617276|NCT00478192|P2|Participant Flow|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617277|NCT00478192|P1|Participant Flow|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617278|NCT00478192|O3|Outcome|Regimen 3 Placebo|
617279|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617280|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617281|NCT00478192|O3|Outcome|Regimen 3 Placebo|
617282|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617283|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617284|NCT00478192|O3|Outcome|Regimen 3 Placebo|
617285|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617286|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617287|NCT00478192|O3|Outcome|Regimen 3 Placebo|
617288|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617289|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617290|NCT00478192|O3|Outcome|Regimen 3 Placebo|
617291|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617292|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617293|NCT00478192|O1|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617294|NCT00478192|O3|Outcome|Regimen 3 Placebo|
617295|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617296|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617297|NCT00478192|O3|Outcome|Regimen 3 Placebo|
617298|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617299|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617300|NCT00478192|E3|Reported Event|Regimen 3 Placebo|
617301|NCT00478192|E2|Reported Event|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
617302|NCT00478192|E1|Reported Event|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
617303|NCT00478140|B1|Baseline|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
617304|NCT00478140|P1|Participant Flow|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
617305|NCT00478140|O1|Outcome|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
617306|NCT00478140|E1|Reported Event|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
617307|NCT00478062|B1|Baseline|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
629409|NCT00449033|B3|Baseline|Total|Total of all reporting groups
617308|NCT00478062|P1|Participant Flow|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
617309|NCT00478062|O1|Outcome|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
617310|NCT00478062|O1|Outcome|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
617311|NCT00478062|O1|Outcome|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
617312|NCT00478062|O1|Outcome|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
617313|NCT00478062|E1|Reported Event|Cell Vaccine After Initial Therapy for Hodgkin Lymphoma|"Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.~Hodgkin's antigens-GM-CSF-expressing cell vaccine~adjuvant therapy"
617314|NCT00478036|B4|Baseline|Total|Total of all reporting groups
617315|NCT00478036|B3|Baseline|Predforte Group|Used predforte eye drops
617316|NCT00478036|B2|Baseline|Acular Group|Used acular LS
617317|NCT00478036|B1|Baseline|Placebo Group|Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
617318|NCT00478036|P3|Participant Flow|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
617319|NCT00478036|P2|Participant Flow|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
617320|NCT00478036|P1|Participant Flow|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
617321|NCT00478036|O3|Outcome|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
617322|NCT00478036|O2|Outcome|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
617323|NCT00478036|O1|Outcome|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
617324|NCT00478036|E3|Reported Event|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
617325|NCT00478036|E2|Reported Event|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
617326|NCT00478036|E1|Reported Event|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
617327|NCT00478023|B6|Baseline|Total|Total of all reporting groups
617328|NCT00478023|B5|Baseline|Placebo|Matched Placebo 4 to 6 hourly
617329|NCT00478023|B4|Baseline|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
617330|NCT00478023|B3|Baseline|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
617331|NCT00478023|B2|Baseline|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
617332|NCT00478023|B1|Baseline|Morphine|Morphine IR 20mg 4-6 hourly
617333|NCT00478023|P5|Participant Flow|Placebo|Matched Placebo 4 to 6 hourly
617334|NCT00478023|P4|Participant Flow|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
617335|NCT00478023|P3|Participant Flow|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
617336|NCT00478023|P2|Participant Flow|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
617337|NCT00478023|P1|Participant Flow|Morphine|Morphine IR 20mg 4-6 hourly
617338|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
617339|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
617340|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
617341|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
617342|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
617343|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
617344|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
617345|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
617346|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
617347|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
617348|NCT00478023|E5|Reported Event|Placebo|Matched Placebo 4 to 6 hourly
617349|NCT00478023|E4|Reported Event|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
617350|NCT00478023|E3|Reported Event|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
617351|NCT00478023|E2|Reported Event|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
617352|NCT00478023|E1|Reported Event|Morphine|Morphine IR 20mg 4-6 hourly
617353|NCT00477971|B3|Baseline|Total|Total of all reporting groups
617354|NCT00477971|B2|Baseline|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
617355|NCT00477971|B1|Baseline|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
617356|NCT00477971|P2|Participant Flow|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
617357|NCT00477971|P1|Participant Flow|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
617392|NCT00477672|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
618620|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
617358|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
617359|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
617360|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
617361|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
617362|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
617363|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
617364|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
617365|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
617366|NCT00477971|E2|Reported Event|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
617367|NCT00477971|E1|Reported Event|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
617368|NCT00477750|B1|Baseline|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
617369|NCT00477750|P1|Participant Flow|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
617370|NCT00477750|O1|Outcome|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression > > Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression >~> Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
617371|NCT00477750|E1|Reported Event|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
617372|NCT00477685|B1|Baseline|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
617373|NCT00477685|P1|Participant Flow|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
617374|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
617375|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
617376|NCT00477685|E1|Reported Event|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
617377|NCT00477672|B4|Baseline|Total|Total of all reporting groups
617378|NCT00477672|B3|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
617379|NCT00477672|B2|Baseline|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
617380|NCT00477672|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
617381|NCT00477672|P3|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
617382|NCT00477672|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
617383|NCT00477672|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
617384|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
617385|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
617386|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
617387|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
617388|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
617389|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
617412|NCT00477594|B3|Baseline|Total|Total of all reporting groups
617393|NCT00477633|B1|Baseline|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
617394|NCT00477633|P1|Participant Flow|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
617395|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
617396|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
617397|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
617398|NCT00477633|E1|Reported Event|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
617399|NCT00477607|B3|Baseline|Total|Total of all reporting groups
617400|NCT00477607|B2|Baseline|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
617401|NCT00477607|B1|Baseline|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
617402|NCT00477607|P2|Participant Flow|Placebo|"Receiving placebo during cisplatin treatment~Placebo supplements (1200mg once a day) were administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
617403|NCT00477607|P1|Participant Flow|Alpha-lipoic Acid|"Receiving alpha-lipoic acid during cisplatin treatment.~alpha-lipoic acid : Supplements (1200mg once a day) was administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
617404|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
617405|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
617406|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
617407|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
617408|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
617409|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
617410|NCT00477607|E2|Reported Event|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
617411|NCT00477607|E1|Reported Event|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
617413|NCT00477594|B2|Baseline|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617414|NCT00477594|B1|Baseline|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617415|NCT00477594|P2|Participant Flow|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617416|NCT00477594|P1|Participant Flow|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617417|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617418|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617419|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617420|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617421|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617422|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617423|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617424|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617425|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617426|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617427|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617428|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617429|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617430|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617431|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617432|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617433|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617434|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617435|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617436|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617437|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617438|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617439|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617440|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617441|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617442|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617474|NCT00477490|B3|Baseline|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617443|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617444|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617445|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617446|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617447|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617448|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617449|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617450|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617451|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617452|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617453|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617454|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617455|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617456|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617457|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617458|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617459|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617460|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617461|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617462|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617463|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617464|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617465|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617466|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617467|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617468|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617469|NCT00477594|E2|Reported Event|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
617470|NCT00477594|E1|Reported Event|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
617471|NCT00477490|B6|Baseline|Total|Total of all reporting groups
617472|NCT00477490|B5|Baseline|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617473|NCT00477490|B4|Baseline|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
618621|NCT00474630|O2|Outcome|Placebo|Placebo
617475|NCT00477490|B2|Baseline|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617476|NCT00477490|B1|Baseline|Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617477|NCT00477490|P9|Participant Flow|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
617478|NCT00477490|P8|Participant Flow|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
617479|NCT00477490|P7|Participant Flow|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
617480|NCT00477490|P6|Participant Flow|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
617481|NCT00477490|P5|Participant Flow|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617482|NCT00477490|P4|Participant Flow|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617483|NCT00477490|P3|Participant Flow|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617484|NCT00477490|P2|Participant Flow|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617485|NCT00477490|P1|Participant Flow|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617486|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
617487|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
617488|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
617489|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
617490|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617491|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617492|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617493|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617494|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617495|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617496|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617497|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617498|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617635|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617636|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
617499|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617500|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617501|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617502|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617503|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617504|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617505|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617506|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617507|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617508|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617509|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617510|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617511|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617512|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617513|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617514|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617515|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617516|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617517|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617518|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617519|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617520|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617521|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617522|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617637|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617523|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617524|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617525|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617526|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617527|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617528|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617529|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
617530|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
617531|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
617532|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
617533|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617534|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617535|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617536|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617537|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
617538|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
617539|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
617540|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
617541|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617542|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617543|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617544|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617545|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617546|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617547|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
633625|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
617548|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617549|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617550|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617551|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617552|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617553|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617554|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
617555|NCT00477490|E13|Reported Event|Part II: Placebo to Desmopressin Melt 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
617556|NCT00477490|E12|Reported Event|Part II: Placebo to Desmopressin Melt 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
617557|NCT00477490|E11|Reported Event|Part II: Placebo to Desmopressin Melt 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
617558|NCT00477490|E10|Reported Event|Part II: Placebo to Desmopressin Melt 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime
617559|NCT00477490|E9|Reported Event|Part II: Desmopressin Melt 100 μg|Participants who took desmopressin melt 100 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
617560|NCT00477490|E8|Reported Event|Part II: Desmopressin Melt 50 μg|Participants who took desmopressin melt 50 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
617561|NCT00477490|E7|Reported Event|Part II: Desmopressin Melt 25 μg|Participants who took desmopressin melt 25 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
617562|NCT00477490|E6|Reported Event|Part II: Desmopressin Melt 10 μg|Participants who took desmopressin melt 10 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
617563|NCT00477490|E5|Reported Event|Part I: Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
617564|NCT00477490|E4|Reported Event|Part I: Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study.
617565|NCT00477490|E3|Reported Event|Part I: Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study.
617566|NCT00477490|E2|Reported Event|Part I: Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study.
617567|NCT00477490|E1|Reported Event|Part I: Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study.
617568|NCT00477464|B1|Baseline|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
617569|NCT00477464|P1|Participant Flow|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
617570|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617571|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617572|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617573|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617574|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617575|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|
617576|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617577|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617578|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617579|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617580|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617581|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617582|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617583|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617584|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617585|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617586|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617587|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617588|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
617589|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
617590|NCT00477464|E1|Reported Event|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
617591|NCT00477451|B5|Baseline|Total|Total of all reporting groups
617592|NCT00477451|B4|Baseline|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617593|NCT00477451|B3|Baseline|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617594|NCT00477451|B2|Baseline|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617595|NCT00477451|B1|Baseline|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617596|NCT00477451|P4|Participant Flow|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617597|NCT00477451|P3|Participant Flow|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617638|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
633626|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
617598|NCT00477451|P2|Participant Flow|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617599|NCT00477451|P1|Participant Flow|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617600|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617601|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617602|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617603|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617604|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617605|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617606|NCT00477451|E4|Reported Event|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617607|NCT00477451|E3|Reported Event|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617608|NCT00477451|E2|Reported Event|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617609|NCT00477451|E1|Reported Event|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
617610|NCT00477386|B3|Baseline|Total|Total of all reporting groups
617611|NCT00477386|B2|Baseline|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617612|NCT00477386|B1|Baseline|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617613|NCT00477386|P2|Participant Flow|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617614|NCT00477386|P1|Participant Flow|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617615|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617616|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617617|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617618|NCT00477386|O1|Outcome|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617619|NCT00477386|E2|Reported Event|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617620|NCT00477386|E1|Reported Event|Phase I Dosing Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
617621|NCT00477334|B3|Baseline|Total|Total of all reporting groups
617622|NCT00477334|B2|Baseline|Placebo Comparator|Placebo twice a day for one day for treatment.
617623|NCT00477334|B1|Baseline|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617624|NCT00477334|P2|Participant Flow|Placebo Comparator|Placebo twice a day for one day for treatment.
617625|NCT00477334|P1|Participant Flow|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617626|NCT00477334|O4|Outcome|Grade 4 Toxicity|
617627|NCT00477334|O3|Outcome|Grade 3 Toxicity|
617628|NCT00477334|O2|Outcome|Grade 2 Toxicity|
617629|NCT00477334|O1|Outcome|Grade 1 Toxicity|
617630|NCT00477334|O4|Outcome|Grade 4 Toxicity|
617631|NCT00477334|O3|Outcome|Grade 3 Toxicity|
617632|NCT00477334|O2|Outcome|Grade 2 Toxicity|
617633|NCT00477334|O1|Outcome|Grade 1 Toxicity|
617634|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
617639|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617640|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
617641|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617642|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
617643|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617644|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
617645|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617646|NCT00477334|E2|Reported Event|Placebo Comparator|Placebo twice a day for one day for treatment.
617647|NCT00477334|E1|Reported Event|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
617648|NCT00477295|B3|Baseline|Total|Total of all reporting groups
617649|NCT00477295|B2|Baseline|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617650|NCT00477295|B1|Baseline|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617651|NCT00477295|P2|Participant Flow|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617652|NCT00477295|P1|Participant Flow|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617653|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617654|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617655|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617656|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617657|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617658|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617731|NCT00477269|E2|Reported Event|Core - Placebo|Core - Placebo
617732|NCT00477269|E1|Reported Event|Core - STI571|Core - STI571
617733|NCT00477230|B3|Baseline|Total|Total of all reporting groups
617659|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617660|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617661|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617662|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.~During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
617663|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617664|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.~During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
617665|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617666|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617667|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617668|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617669|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617670|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617734|NCT00477230|B2|Baseline|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
618622|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
617671|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617672|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617673|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617674|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617675|NCT00477295|E2|Reported Event|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617676|NCT00477295|E1|Reported Event|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
617677|NCT00477269|B3|Baseline|Total|Total of all reporting groups
617678|NCT00477269|B2|Baseline|Placebo|Placebo
617679|NCT00477269|B1|Baseline|STI571|STI571
617680|NCT00477269|P3|Participant Flow|All Patients|Open label extension
617681|NCT00477269|P2|Participant Flow|Placebo|Placebo
617682|NCT00477269|P1|Participant Flow|STI571|STI571
617683|NCT00477269|O2|Outcome|Placebo|Placebo
617684|NCT00477269|O1|Outcome|STI571|STI571
617685|NCT00477269|O2|Outcome|Placebo|Placebo
617686|NCT00477269|O1|Outcome|STI571|STI571
617687|NCT00477269|O2|Outcome|Placebo|Placebo
617688|NCT00477269|O1|Outcome|STI571|STI571
617689|NCT00477269|O2|Outcome|Placebo|Placebo
617690|NCT00477269|O1|Outcome|STI571|STI571
617691|NCT00477269|O2|Outcome|Placebo|Placebo
617692|NCT00477269|O1|Outcome|STI571|STI571
617693|NCT00477269|O2|Outcome|Placebo|Placebo
617694|NCT00477269|O1|Outcome|STI571|STI571
617695|NCT00477269|O2|Outcome|Placebo|Placebo
617696|NCT00477269|O1|Outcome|STI571|STI571
617697|NCT00477269|O2|Outcome|Placebo|Placebo
617698|NCT00477269|O1|Outcome|STI571|STI571
617699|NCT00477269|O2|Outcome|Placebo|Placebo
617700|NCT00477269|O1|Outcome|STI571|STI571
617701|NCT00477269|O2|Outcome|Placebo|Placebo
617702|NCT00477269|O1|Outcome|STI571|STI571
617703|NCT00477269|O2|Outcome|Placebo|Placebo
617704|NCT00477269|O1|Outcome|STI571|STI571
617705|NCT00477269|O2|Outcome|Placebo|Placebo
617706|NCT00477269|O1|Outcome|STI571|STI571
617707|NCT00477269|O2|Outcome|Placebo|Placebo
617708|NCT00477269|O1|Outcome|STI571|STI571
617709|NCT00477269|O2|Outcome|Placebo|Placebo
617710|NCT00477269|O1|Outcome|STI571|STI571
617711|NCT00477269|O2|Outcome|Placebo|Placebo
617712|NCT00477269|O1|Outcome|STI571|STI571
617713|NCT00477269|O2|Outcome|Placebo|Placebo
617714|NCT00477269|O1|Outcome|STI571|STI571
617715|NCT00477269|O2|Outcome|Placebo|Placebo
617716|NCT00477269|O1|Outcome|STI571|STI571
617717|NCT00477269|O2|Outcome|Placebo|Placebo
617718|NCT00477269|O1|Outcome|STI571|STI571
617719|NCT00477269|O2|Outcome|Placebo|Placebo
617720|NCT00477269|O1|Outcome|STI571|STI571
617721|NCT00477269|O2|Outcome|Placebo|Placebo
617722|NCT00477269|O1|Outcome|STI571|STI571
617723|NCT00477269|O2|Outcome|Placebo|Placebo
617724|NCT00477269|O1|Outcome|STI571|STI571
617725|NCT00477269|O2|Outcome|Placebo|Placebo
617726|NCT00477269|O1|Outcome|STI571|STI571
617727|NCT00477269|O1|Outcome|All Patients|Open label extension
617728|NCT00477269|O2|Outcome|Placebo|Placebo
617729|NCT00477269|O1|Outcome|STI571|STI571
617730|NCT00477269|E3|Reported Event|Extension - STI571|Extension - STI571
617735|NCT00477230|B1|Baseline|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
617736|NCT00477230|P2|Participant Flow|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
617737|NCT00477230|P1|Participant Flow|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
617738|NCT00477230|O2|Outcome|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
617739|NCT00477230|O1|Outcome|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
617740|NCT00477230|E2|Reported Event|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
617741|NCT00477230|E1|Reported Event|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
617742|NCT00477204|B3|Baseline|Total|Total of all reporting groups
617743|NCT00477204|B2|Baseline|Zocor|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
617744|NCT00477204|B1|Baseline|Vytorin|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
617745|NCT00477204|P2|Participant Flow|Simvastatin|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
617746|NCT00477204|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
617747|NCT00477204|O2|Outcome|Zocor (Simvastatin)|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
617748|NCT00477204|O1|Outcome|Vytorin (Ezetimibe/Simvastatin)|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
617749|NCT00477204|E2|Reported Event|Zocor [Simvastatin]|Zocor [simvastatin] 20 mg taken daily for 6 months to compare in a 2- arm design to Vytorin [simvastatin + ezetimibe].
617750|NCT00477204|E1|Reported Event|Vytorin (Simvastatin + Ezetimibe)|Vytorin [simvastatin + ezetimibe]20 mg taken daily for 6 months to compare in a 2- arm design to Zocor [simvastatin] .
617751|NCT00477191|B1|Baseline|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and then 50 mg once a week for 3 months."
617752|NCT00477191|P1|Participant Flow|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
617753|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
617754|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
617755|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
617756|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
617757|NCT00477191|E1|Reported Event|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
617758|NCT00477165|B3|Baseline|Total|Total of all reporting groups
617759|NCT00477165|B2|Baseline|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
617760|NCT00477165|B1|Baseline|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
617761|NCT00477165|P2|Participant Flow|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
617762|NCT00477165|P1|Participant Flow|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
617763|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
617764|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
617765|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
617766|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
617767|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
617768|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
617769|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
617770|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
617771|NCT00477165|E2|Reported Event|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
617772|NCT00477165|E1|Reported Event|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
617773|NCT00477152|B1|Baseline|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
617774|NCT00477152|P1|Participant Flow|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
617775|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
617776|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
617777|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
618623|NCT00474630|O2|Outcome|Placebo|Placebo
617778|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
617779|NCT00477152|E1|Reported Event|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
617780|NCT00477087|B1|Baseline|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
617781|NCT00477087|P1|Participant Flow|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
617782|NCT00477087|O1|Outcome|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
617783|NCT00477087|O1|Outcome|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
617784|NCT00477087|O1|Outcome|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
617785|NCT00477087|E1|Reported Event|GM-CSF Plus Mitoxantrone|GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days
617786|NCT00476957|B3|Baseline|Total|Total of all reporting groups
617787|NCT00476957|B2|Baseline|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
617788|NCT00476957|B1|Baseline|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
617789|NCT00476957|P2|Participant Flow|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
617790|NCT00476957|P1|Participant Flow|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
617791|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
617792|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
617793|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
617794|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
617795|NCT00476957|E2|Reported Event|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
617796|NCT00476957|E1|Reported Event|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
617797|NCT00476827|B7|Baseline|Total|Total of all reporting groups
617798|NCT00476827|B6|Baseline|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
617799|NCT00476827|B5|Baseline|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
617800|NCT00476827|B4|Baseline|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617801|NCT00476827|B3|Baseline|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617802|NCT00476827|B2|Baseline|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617803|NCT00476827|B1|Baseline|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
617804|NCT00476827|P6|Participant Flow|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
617805|NCT00476827|P5|Participant Flow|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
617806|NCT00476827|P4|Participant Flow|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617807|NCT00476827|P3|Participant Flow|Bevacizumab / Irinotecan (Camptosar®, CPT-11)|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617808|NCT00476827|P2|Participant Flow|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617809|NCT00476827|P1|Participant Flow|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
617810|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
617811|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
617812|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617879|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
617813|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617814|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617815|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
617816|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
617817|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
617818|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617819|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617820|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617821|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
617822|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
617823|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
617824|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617825|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617826|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617827|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
617828|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
617829|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
617830|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617831|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617832|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
617833|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
617834|NCT00476827|E4|Reported Event|Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)|
617835|NCT00476827|E3|Reported Event|Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine|
617836|NCT00476827|E2|Reported Event|Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)|
617837|NCT00476827|E1|Reported Event|Avastin (Bevacizumab)/ Capecitabine (Xeloda)|
617838|NCT00476788|B1|Baseline|Omnipod Device|Patients will be placed on an Omnipod insulin pump
617839|NCT00476788|P1|Participant Flow|Omnipod Device|Patients will be placed on an Omnipod insulin pump
617840|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
617841|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
617842|NCT00476788|E1|Reported Event|Omnipod Device|Patients will be placed on an Omnipod insulin pump
617843|NCT00476645|B1|Baseline|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
617844|NCT00476645|P1|Participant Flow|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
617845|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
617846|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
617847|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
617848|NCT00476645|E1|Reported Event|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
617849|NCT00476593|B5|Baseline|Total|Total of all reporting groups
617850|NCT00476593|B4|Baseline|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
617851|NCT00476593|B3|Baseline|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
618085|NCT00475722|B3|Baseline|Total|Total of all reporting groups
617852|NCT00476593|B2|Baseline|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
617853|NCT00476593|B1|Baseline|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
617854|NCT00476593|P4|Participant Flow|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
617855|NCT00476593|P3|Participant Flow|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
617856|NCT00476593|P2|Participant Flow|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
617857|NCT00476593|P1|Participant Flow|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
617858|NCT00476593|O4|Outcome|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
617859|NCT00476593|O3|Outcome|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
617860|NCT00476593|O2|Outcome|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
617861|NCT00476593|O1|Outcome|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
617862|NCT00476593|E4|Reported Event|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
617863|NCT00476593|E3|Reported Event|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
617864|NCT00476593|E2|Reported Event|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
617865|NCT00476593|E1|Reported Event|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
617866|NCT00476476|B3|Baseline|Total|Total of all reporting groups
617867|NCT00476476|B2|Baseline|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
617868|NCT00476476|B1|Baseline|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
617869|NCT00476476|P2|Participant Flow|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
617870|NCT00476476|P1|Participant Flow|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
617871|NCT00476476|O2|Outcome|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
617872|NCT00476476|O1|Outcome|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
617873|NCT00476476|E1|Reported Event|Erlotinib|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
617874|NCT00476242|B3|Baseline|Total|Total of all reporting groups
617875|NCT00476242|B2|Baseline|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
617876|NCT00476242|B1|Baseline|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
617877|NCT00476242|P2|Participant Flow|Memantine and Vivitrol|Participants treated with memantine 40 mg/d capsules and Vivitrol.
617878|NCT00476242|P1|Participant Flow|Placebo and Vivitrol|Participants treated with placebo capsules and Vivitrol.
633627|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
617880|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
617881|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
617882|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
617883|NCT00476242|E2|Reported Event|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
617884|NCT00476242|E1|Reported Event|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
617885|NCT00476229|B1|Baseline|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
617886|NCT00476229|P1|Participant Flow|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
617887|NCT00476229|O1|Outcome|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
617888|NCT00476229|E1|Reported Event|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
617889|NCT00476151|B3|Baseline|Total|Total of all reporting groups
617890|NCT00476151|B2|Baseline|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
617891|NCT00476151|B1|Baseline|Placebo Cream|vehicle cream applied twice daily for 4 weeks
617892|NCT00476151|P2|Participant Flow|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
617893|NCT00476151|P1|Participant Flow|Placebo Cream|vehicle cream applied twice daily for 4 weeks
617894|NCT00476151|O2|Outcome|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
617895|NCT00476151|O1|Outcome|Placebo Cream|vehicle cream applied twice daily for 4 weeks
617896|NCT00476151|E2|Reported Event|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
617897|NCT00476151|E1|Reported Event|Placebo Cream|vehicle cream applied twice daily for 4 weeks
617898|NCT00476086|B1|Baseline|Oxaliplatin/ Gemcitabine Then Radiation|"Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.~on"
617899|NCT00476086|P1|Participant Flow|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
617900|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
617901|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
617902|NCT00476086|E2|Reported Event|Radiation|On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
617903|NCT00476086|E1|Reported Event|Oxaliplatin/ Gemcitabine|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.
617904|NCT00476047|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
617905|NCT00476047|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
617906|NCT00476047|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
617907|NCT00476047|O1|Outcome|Patient Who Achieved CR After Any Prior Therapy|Patients who received study treatment and who had achieved a complete remission (CR) after any prior therapy.
617908|NCT00476047|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV"
617909|NCT00476047|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
617910|NCT00476047|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|"Patients receive tositumomab and iodine I 131 tositumomab IV over 90 minutes on day 0 and then again 7-14 days later over 30-60 minutes.~Tositumomab and Iodine I 131 Tositumomab: Give IV~Laboratory Biomarker Analysis: Correlative studies"
617911|NCT00476021|B3|Baseline|Total|Total of all reporting groups
617912|NCT00476021|B2|Baseline|Delayed IUD Insertion (6-8 Weeks After Delivery)|"delayed IUD insertion (6-8 weeks after delivery)~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
617913|NCT00476021|B1|Baseline|Immediate Postplacental IUD Insertion|"immediate postplacental IUD insertion~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
617914|NCT00476021|P2|Participant Flow|Delayed IUD Insertion|Delayed LNG-IUD insertion
617915|NCT00476021|P1|Participant Flow|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
617916|NCT00476021|O2|Outcome|Follow-up for IUD Insertion for Ineligible Participants|Ineligible participants were followed for 6 months to evaluate whether they received an IUD from their ob/gyn
617917|NCT00476021|O1|Outcome|Pregnancy Within 6 Months for Ineligible Participants|If a participant was found to be ineligible as a result of postenrollment criteria, she was instructed to follow up with her primary obstetrician or midwife for postpartum contraception and delayed IUD insertion
617918|NCT00476021|O2|Outcome|Delayed IUD Insertion|Infection after delayed LNG-IUD insertion
617919|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Infection after postplacental LNG-IUD insertion
617920|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
617921|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
617922|NCT00476021|O1|Outcome|Delayed IUD Insertion|Followed up for delayed IUD insertion
617923|NCT00476021|O1|Outcome|Received Postplacental IUD|Received postplacental LNG-IUD
617924|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
617925|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
617926|NCT00476021|E2|Reported Event|Delayed IUD Insertion|Delayed LNG-IUD insertion
617927|NCT00476021|E1|Reported Event|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
617928|NCT00476008|B3|Baseline|Total|Total of all reporting groups
617929|NCT00476008|B2|Baseline|Placebo|Placebo : Placebo BID for 12 months
617930|NCT00476008|B1|Baseline|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617931|NCT00476008|P2|Participant Flow|Placebo|Placebo : Placebo BID for 12 months
617932|NCT00476008|P1|Participant Flow|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617933|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617934|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617935|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617936|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617937|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617938|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617939|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617940|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617941|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617942|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617943|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617944|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617945|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617946|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617947|NCT00476008|O2|Outcome|Memantine|Memantine: One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
617948|NCT00476008|O1|Outcome|Placebo|Placebo: One tablet placebo morning and evening (BID) for 12 months
617949|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617950|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
617951|NCT00476008|O2|Outcome|Placebo|Placebo : Placebo BID for 12 months
617952|NCT00476008|O1|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617953|NCT00476008|E2|Reported Event|Placebo|Placebo : Placebo BID for 12 months
617954|NCT00476008|E1|Reported Event|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
617955|NCT00475904|B4|Baseline|Total|Total of all reporting groups
617956|NCT00475904|B3|Baseline|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
617957|NCT00475904|B2|Baseline|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
617958|NCT00475904|B1|Baseline|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
617959|NCT00475904|P3|Participant Flow|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
617960|NCT00475904|P2|Participant Flow|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
617961|NCT00475904|P1|Participant Flow|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
617962|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
617963|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
617964|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
617965|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
617966|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
617967|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
617968|NCT00475904|E3|Reported Event|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
617969|NCT00475904|E2|Reported Event|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
617970|NCT00475904|E1|Reported Event|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
617971|NCT00475878|B3|Baseline|Total|Total of all reporting groups
617972|NCT00475878|B2|Baseline|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
617973|NCT00475878|B1|Baseline|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
617974|NCT00475878|P2|Participant Flow|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
617975|NCT00475878|P1|Participant Flow|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
617976|NCT00475878|O2|Outcome|Placebo|individuals were given a placebo study medication prior to buprenorphine induction
617977|NCT00475878|O1|Outcome|10 mg Escitalopram|individuals were given 10mg escitalopram prior to buprenorphine induction
617978|NCT00475878|O2|Outcome|Placebo|in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction
617979|NCT00475878|O1|Outcome|10 mg Escitalopram|in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction
617980|NCT00475878|E2|Reported Event|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
617981|NCT00475878|E1|Reported Event|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
617982|NCT00475865|B4|Baseline|Total|Total of all reporting groups
617983|NCT00475865|B3|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617984|NCT00475865|B2|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617985|NCT00475865|B1|Baseline|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617986|NCT00475865|P3|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
617987|NCT00475865|P2|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
617988|NCT00475865|P1|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
617989|NCT00475865|O2|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617990|NCT00475865|O1|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617991|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617992|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617993|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617994|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617995|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617996|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617997|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617998|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
617999|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618000|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618001|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618002|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618003|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618004|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618005|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618006|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618007|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618008|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618009|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618010|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618011|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618012|NCT00475865|E3|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618013|NCT00475865|E2|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618014|NCT00475865|E1|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
618015|NCT00475852|B3|Baseline|Total|Total of all reporting groups
618016|NCT00475852|B2|Baseline|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618017|NCT00475852|B1|Baseline|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618018|NCT00475852|P2|Participant Flow|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618019|NCT00475852|P1|Participant Flow|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618020|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618021|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618022|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618023|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618024|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618025|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618026|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618027|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618028|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618029|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618030|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618031|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618032|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618033|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618034|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618035|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618036|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618037|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618038|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618039|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618040|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618041|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618042|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618043|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618044|NCT00475852|E2|Reported Event|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618045|NCT00475852|E1|Reported Event|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
618046|NCT00475787|B3|Baseline|Total|Total of all reporting groups
618047|NCT00475787|B2|Baseline|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618048|NCT00475787|B1|Baseline|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618049|NCT00475787|P2|Participant Flow|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618050|NCT00475787|P1|Participant Flow|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618051|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618052|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618053|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618054|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
633628|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
618055|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618056|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618057|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618058|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618059|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618060|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618061|NCT00475787|E2|Reported Event|Sham Intervention|Detuned Ultrasound
618062|NCT00475787|E1|Reported Event|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
618063|NCT00475735|B7|Baseline|Total|Total of all reporting groups
618064|NCT00475735|B6|Baseline|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
618065|NCT00475735|B5|Baseline|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
618066|NCT00475735|B4|Baseline|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
618067|NCT00475735|B3|Baseline|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
618068|NCT00475735|B2|Baseline|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
618069|NCT00475735|B1|Baseline|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
618070|NCT00475735|P6|Participant Flow|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
618071|NCT00475735|P5|Participant Flow|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
618072|NCT00475735|P4|Participant Flow|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
618073|NCT00475735|P3|Participant Flow|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
618074|NCT00475735|P2|Participant Flow|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
618075|NCT00475735|P1|Participant Flow|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
618076|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
618077|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
618078|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
618079|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
618080|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
618081|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
618082|NCT00475735|E3|Reported Event|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
618083|NCT00475735|E2|Reported Event|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
618084|NCT00475735|E1|Reported Event|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
618086|NCT00475722|B2|Baseline|2 Mediterranean|"Mediterranean Diet using an exchange list~2 Mediterranean: 6 months telephone counseling"
618087|NCT00475722|B1|Baseline|1 Healthy Eating|"Healthy People 2010 Diet using an exchange list~1 Healthy Eating: 6 months telephone counseling"
618088|NCT00475722|P2|Participant Flow|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
618089|NCT00475722|P1|Participant Flow|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
618090|NCT00475722|O2|Outcome|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
618091|NCT00475722|O1|Outcome|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
618092|NCT00475722|E2|Reported Event|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
618093|NCT00475722|E1|Reported Event|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
618094|NCT00475709|B1|Baseline|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
618095|NCT00475709|P1|Participant Flow|Subjects Implanted With Trifecta Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
618096|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
618097|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
618098|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
618099|NCT00475709|E1|Reported Event|Subjects Implanted With Trifecta Valve|
618100|NCT00475670|B3|Baseline|Total|Total of all reporting groups
618101|NCT00475670|B2|Baseline|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618102|NCT00475670|B1|Baseline|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618103|NCT00475670|P2|Participant Flow|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/square meter (m^2), IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618104|NCT00475670|P1|Participant Flow|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618105|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618106|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618107|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618108|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618109|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618110|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618127|NCT00475657|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618128|NCT00475657|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618111|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618112|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618113|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618114|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618115|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618116|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618117|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618118|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618119|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618120|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618121|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618122|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618123|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618124|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618125|NCT00475670|E2|Reported Event|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
618126|NCT00475670|E1|Reported Event|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
618129|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618130|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618131|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618132|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618133|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618134|NCT00475657|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
618135|NCT00475501|B5|Baseline|Total|Total of all reporting groups
618136|NCT00475501|B4|Baseline|Vehicle Placebo|weekly vehicle injection daily placebo pill
618137|NCT00475501|B3|Baseline|Testosterone Finasteride|125 mg testosterone enanthate/week i.m. 5 mg finasteride/day p.o.
618138|NCT00475501|B2|Baseline|Vehicle Finasteride|weekly vehicle injection 5 mg finasteride/day p.o.
618139|NCT00475501|B1|Baseline|Testosterone Vehicle|125 mg testosterone enanthate/week i.m. daily placebo pill
618140|NCT00475501|P4|Participant Flow|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618141|NCT00475501|P3|Participant Flow|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618142|NCT00475501|P2|Participant Flow|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
618143|NCT00475501|P1|Participant Flow|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618144|NCT00475501|O4|Outcome|Arm 4|"placebo~Life Satisfaction A"
618145|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
618146|NCT00475501|O2|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
618147|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Life Satisfaction A"
618148|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618149|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618150|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
618151|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618152|NCT00475501|O4|Outcome|Arm 4|"placebo~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
618153|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
618154|NCT00475501|O2|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
618155|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
618156|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618157|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618158|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
618198|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
633629|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
618159|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618160|NCT00475501|O4|Outcome|Arm 4|"placebo~Benton Test -Judgment of Line Orientation"
618161|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Benton Test -Judgment of Line Orientation"
618162|NCT00475501|O2|Outcome|Arm 2|"finasteride~Benton Test -Judgment of Line Orientation~Finasteride : 5 mg, oral, once/day, for 52 weeks"
618163|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Benton Test -Judgment of Line Orientation"
618164|NCT00475501|O4|Outcome|Arm 4|"placebo~Trail Making Test A"
618165|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Trail Making Test A"
618166|NCT00475501|O2|Outcome|Arm 2|"finasteride~Trail Making Test A Finasteride : 5 mg, oral, once/day, for 52 weeks"
618167|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Trail Making Test A"
618168|NCT00475501|O4|Outcome|Arm 4|"placebo~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
618169|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
618170|NCT00475501|O2|Outcome|Arm 2|"finasteride~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test Finasteride : 5 mg, oral, once/day, for 52 weeks"
618171|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
618172|NCT00475501|O4|Outcome|Vehicle Placebo|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
618173|NCT00475501|O3|Outcome|Testosterone Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
618174|NCT00475501|O2|Outcome|Vehicle Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
618175|NCT00475501|O1|Outcome|Testosterone Vehicle|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
618176|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618177|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618178|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
618179|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
618180|NCT00475501|O4|Outcome|Vehicle Placebo|grip strength measure on a dynamometer
618181|NCT00475501|O3|Outcome|Testosterone Finasteride|grip strength measure on a dynamometer
618182|NCT00475501|O2|Outcome|Vehicle Finasteride|grip strength measure on a dynamometer
618183|NCT00475501|O1|Outcome|Testosterone Vehicle|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~grip strength measure on a dynamometer"
618184|NCT00475501|O4|Outcome|Arm 4|"placebo~Measurement of leg press strength, 1-RM"
618185|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Measurement of leg press strength, 1-RM"
618186|NCT00475501|O2|Outcome|Arm 2|"finasteride~Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks"
618187|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Measurement of leg press strength, 1-RM"
618188|NCT00475501|E4|Reported Event|Arm 4|placebo
618189|NCT00475501|E3|Reported Event|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks"
618190|NCT00475501|E2|Reported Event|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks"
618191|NCT00475501|E1|Reported Event|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks"
618192|NCT00475423|B1|Baseline|Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15.
618193|NCT00475423|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
618194|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618195|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618196|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618197|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618199|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618200|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618201|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618202|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618203|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618204|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618205|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618206|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618207|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618208|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618209|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618210|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618211|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618212|NCT00475423|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
618213|NCT00475332|B1|Baseline|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
618214|NCT00475332|P1|Participant Flow|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
618215|NCT00475332|O1|Outcome|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
618216|NCT00475332|O1|Outcome|Radiation Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
618217|NCT00475332|E1|Reported Event|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
618218|NCT00475319|B4|Baseline|Total|Total of all reporting groups
618219|NCT00475319|B3|Baseline|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618220|NCT00475319|B2|Baseline|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618221|NCT00475319|B1|Baseline|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618222|NCT00475319|P3|Participant Flow|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618223|NCT00475319|P2|Participant Flow|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618224|NCT00475319|P1|Participant Flow|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618225|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618226|NCT00475319|O2|Outcome|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618227|NCT00475319|O1|Outcome|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618228|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
618229|NCT00475319|O2|Outcome|2% OPC-12759 Ophthalmic Suspension|2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
618230|NCT00475319|O1|Outcome|1% OPC-12759 Ophthalmic Suspension|1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
618231|NCT00475319|E3|Reported Event|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618232|NCT00475319|E2|Reported Event|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618233|NCT00475319|E1|Reported Event|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
618234|NCT00475306|B5|Baseline|Total|Total of all reporting groups
618235|NCT00475306|B4|Baseline|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
618236|NCT00475306|B3|Baseline|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
618237|NCT00475306|B2|Baseline|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
618238|NCT00475306|B1|Baseline|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
618239|NCT00475306|P4|Participant Flow|Metoclopramide 10+Diphenhydramine|Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously
618240|NCT00475306|P3|Participant Flow|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
618241|NCT00475306|P2|Participant Flow|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
618242|NCT00475306|P1|Participant Flow|Metoclopramide 20 mg+Diphenhydramine|Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously
618243|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
618244|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
618245|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
618246|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
618247|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
618248|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
618249|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
618250|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
618251|NCT00475306|E4|Reported Event|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
618252|NCT00475306|E3|Reported Event|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
618253|NCT00475306|E2|Reported Event|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
618254|NCT00475306|E1|Reported Event|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
618255|NCT00475241|B3|Baseline|Total|Total of all reporting groups
618256|NCT00475241|B2|Baseline|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
618257|NCT00475241|B1|Baseline|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
618258|NCT00475241|P2|Participant Flow|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
618259|NCT00475241|P1|Participant Flow|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
618260|NCT00475241|O2|Outcome|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
618261|NCT00475241|O1|Outcome|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
618262|NCT00475241|E2|Reported Event|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
618263|NCT00475241|E1|Reported Event|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
618264|NCT00475228|B3|Baseline|Total|Total of all reporting groups
618265|NCT00475228|B2|Baseline|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
618266|NCT00475228|B1|Baseline|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
618267|NCT00475228|P2|Participant Flow|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618268|NCT00475228|P1|Participant Flow|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618269|NCT00475228|O2|Outcome|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
618270|NCT00475228|O1|Outcome|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
618271|NCT00475228|O2|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted immediately after completion of D&E in all 44 participants~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618272|NCT00475228|O1|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted at standard time post-procedure (3-6 weeks post D&E procedure) in 20 participants. The remaining 24 women did not return 3-6 weeks after the D&E.~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618273|NCT00475228|O2|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618274|NCT00475228|O1|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618275|NCT00475228|E2|Reported Event|Arm 2|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618276|NCT00475228|E1|Reported Event|Arm I|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
618277|NCT00475176|B1|Baseline|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
618278|NCT00475176|P1|Participant Flow|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.
618279|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
618280|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
618281|NCT00475176|E1|Reported Event|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
618282|NCT00475150|B3|Baseline|Total|Total of all reporting groups
618283|NCT00475150|B2|Baseline|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618284|NCT00475150|B1|Baseline|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618285|NCT00475150|P2|Participant Flow|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618286|NCT00475150|P1|Participant Flow|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618287|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618288|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618289|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618290|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618291|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618292|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618293|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618294|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618295|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618296|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
618297|NCT00475150|E1|Reported Event|All Patients Receiving Cediranib Maleate|All patients receiving oral cediranib maleate, regardless of diagnosis were analyzed for toxicity.
618298|NCT00475085|B5|Baseline|Total|Total of all reporting groups
618299|NCT00475085|B4|Baseline|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618300|NCT00475085|B3|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618301|NCT00475085|B2|Baseline|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618302|NCT00475085|B1|Baseline|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618303|NCT00475085|P4|Participant Flow|Arm 4 Palonosetron, Dexamethasone, Compazine, Dexamethasone|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618304|NCT00475085|P3|Participant Flow|Arm 3 Aprepitant, Palonosetron, Dexamethasone|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618305|NCT00475085|P2|Participant Flow|Arm 2 Granisetron, Dexamethasone, Compazine|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618306|NCT00475085|P1|Participant Flow|Arm 1 Palonosetron, Dexamethasone, Compazine|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618307|NCT00475085|O4|Outcome|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618397|NCT00474929|B3|Baseline|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
618308|NCT00475085|O3|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618309|NCT00475085|O2|Outcome|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618310|NCT00475085|O1|Outcome|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618311|NCT00475085|E4|Reported Event|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618312|NCT00475085|E3|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618313|NCT00475085|E2|Reported Event|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618314|NCT00475085|E1|Reported Event|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
618315|NCT00475033|B3|Baseline|Total|Total of all reporting groups
618316|NCT00475033|B2|Baseline|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618317|NCT00475033|B1|Baseline|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618318|NCT00475033|P2|Participant Flow|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618319|NCT00475033|P1|Participant Flow|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618320|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618321|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618398|NCT00474929|B2|Baseline|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
618399|NCT00474929|B1|Baseline|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day;
618400|NCT00474929|P5|Participant Flow|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
618322|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618323|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618324|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618325|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618326|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618327|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618328|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618329|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618330|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618331|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618401|NCT00474929|P4|Participant Flow|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
618402|NCT00474929|P3|Participant Flow|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
618332|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618333|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618334|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618335|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618336|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618337|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618338|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618339|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618340|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618341|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618403|NCT00474929|P2|Participant Flow|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
618404|NCT00474929|P1|Participant Flow|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
618342|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618343|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618344|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618345|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618346|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618347|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618348|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618349|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618350|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618351|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618437|NCT00474851|P1|Participant Flow|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618352|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618353|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618354|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618355|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618356|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618357|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618358|NCT00475033|E8|Reported Event|7vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618359|NCT00475033|E7|Reported Event|13vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
618360|NCT00475033|E6|Reported Event|7vPnC Toddler Dose|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193."
618361|NCT00475033|E5|Reported Event|13vPnC Toddler Dose|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199."
618362|NCT00475033|E4|Reported Event|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
618363|NCT00475033|E3|Reported Event|13vPnC After the Infant Series|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
618405|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
618615|NCT00474630|O2|Outcome|Placebo|Placebo
618364|NCT00475033|E2|Reported Event|7vPnC Infant Series|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279."
618365|NCT00475033|E1|Reported Event|13vPnC Infant Series|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273."
618366|NCT00474994|B1|Baseline|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
618367|NCT00474994|P1|Participant Flow|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
618368|NCT00474994|O1|Outcome|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
618369|NCT00474994|E1|Reported Event|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
618370|NCT00474968|B3|Baseline|Total|Total of all reporting groups
618371|NCT00474968|B2|Baseline|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
618372|NCT00474968|B1|Baseline|SoftPAP|Samples collected using the SoftPAP Collector
618373|NCT00474968|P2|Participant Flow|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
618374|NCT00474968|P1|Participant Flow|SoftPAP|Samples collected using the SoftPAP Collector
618375|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
618376|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
618377|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
618378|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
618379|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
618380|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
618381|NCT00474968|E2|Reported Event|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
618382|NCT00474968|E1|Reported Event|SoftPAP|Samples collected using the SoftPAP Collector
618383|NCT00474955|B1|Baseline|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618384|NCT00474955|P1|Participant Flow|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a [Pegasys] [40 kilo Dalton (kDa)], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of <15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618385|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618386|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618387|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618388|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618389|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618390|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618391|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618392|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618393|NCT00474955|E1|Reported Event|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
618394|NCT00474929|B6|Baseline|Total|Total of all reporting groups
618395|NCT00474929|B5|Baseline|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
618396|NCT00474929|B4|Baseline|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
618406|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
618407|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|"This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II.~Therefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77)."
618408|NCT00474929|O4|Outcome|Phase I, Dose Level 3|Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
618409|NCT00474929|O3|Outcome|Phase I, Dose Level 2|Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
618410|NCT00474929|O2|Outcome|Phase I, Dose Level 1|Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
618411|NCT00474929|O1|Outcome|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
618412|NCT00474929|E5|Reported Event|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
618413|NCT00474929|E4|Reported Event|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
618414|NCT00474929|E3|Reported Event|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
618415|NCT00474929|E2|Reported Event|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
618416|NCT00474929|E1|Reported Event|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
618417|NCT00474903|B4|Baseline|Total|Total of all reporting groups
618418|NCT00474903|B3|Baseline|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618419|NCT00474903|B2|Baseline|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618420|NCT00474903|B1|Baseline|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
618421|NCT00474903|P3|Participant Flow|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618422|NCT00474903|P2|Participant Flow|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618423|NCT00474903|P1|Participant Flow|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
618424|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618425|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618426|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
618427|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618428|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618429|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
618430|NCT00474903|E3|Reported Event|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618431|NCT00474903|E2|Reported Event|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
618432|NCT00474903|E1|Reported Event|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
618433|NCT00474851|B3|Baseline|Total|Total of all reporting groups
618434|NCT00474851|B2|Baseline|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618435|NCT00474851|B1|Baseline|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618436|NCT00474851|P2|Participant Flow|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618438|NCT00474851|O2|Outcome|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618439|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618440|NCT00474851|O2|Outcome|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618441|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618442|NCT00474851|E2|Reported Event|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618443|NCT00474851|E1|Reported Event|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
618444|NCT00474812|B1|Baseline|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618445|NCT00474812|P1|Participant Flow|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618446|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618447|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618448|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618449|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618450|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618451|NCT00474812|E1|Reported Event|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
618452|NCT00474786|B3|Baseline|Total|Total of all reporting groups
618453|NCT00474786|B2|Baseline|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618454|NCT00474786|B1|Baseline|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618455|NCT00474786|P2|Participant Flow|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618456|NCT00474786|P1|Participant Flow|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618457|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618458|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618459|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618460|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618461|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618462|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618463|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618464|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618465|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618466|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618467|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618616|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618617|NCT00474630|O2|Outcome|Placebo|Placebo
618468|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618469|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618470|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618471|NCT00474786|E2|Reported Event|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618472|NCT00474786|E1|Reported Event|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
618473|NCT00474760|B8|Baseline|Total|Total of all reporting groups
618474|NCT00474760|B7|Baseline|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618475|NCT00474760|B6|Baseline|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
618476|NCT00474760|B5|Baseline|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
618477|NCT00474760|B4|Baseline|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618478|NCT00474760|B3|Baseline|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618479|NCT00474760|B2|Baseline|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618480|NCT00474760|B1|Baseline|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618481|NCT00474760|P7|Participant Flow|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing’s sarcoma family of tumors [ESFT] extension cohort.
618482|NCT00474760|P6|Participant Flow|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort.
618483|NCT00474760|P5|Participant Flow|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort.
618484|NCT00474760|P4|Participant Flow|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618485|NCT00474760|P3|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618486|NCT00474760|P2|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618487|NCT00474760|P1|Participant Flow|Figitumumab 3 mg/kg|Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618488|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
618489|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
618490|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration for dose escalation, RP2D extension, and RP2D ACC and sarcoma extension cohorts, 4 weeks in duration for RP2D ESFT extension cohort).
618491|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618492|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618618|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618619|NCT00474630|O2|Outcome|Placebo|Placebo
618493|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618494|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618495|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618496|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618497|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618498|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618499|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618500|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618501|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618502|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618503|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618504|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618505|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618506|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618507|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618508|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618509|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618510|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618511|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618512|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618513|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618514|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618515|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618516|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618517|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618518|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618519|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618520|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618521|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618522|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618523|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618524|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618525|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618526|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618527|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618528|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618529|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618530|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618531|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618532|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618533|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618534|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618535|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618536|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618537|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618538|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618539|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618540|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618541|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618542|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618543|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618544|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618545|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618546|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618547|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618548|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618549|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618550|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618551|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618552|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618553|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618554|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618555|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618556|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618557|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618558|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618559|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618560|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618561|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618562|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618563|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618564|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618565|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618566|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618567|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618568|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618569|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618570|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618571|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618572|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
618573|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618574|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618575|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618576|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618577|NCT00474760|O7|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618578|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
618579|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
618580|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618581|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618582|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618583|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618584|NCT00474760|E7|Reported Event|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
618585|NCT00474760|E6|Reported Event|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
618586|NCT00474760|E5|Reported Event|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
618587|NCT00474760|E4|Reported Event|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618588|NCT00474760|E3|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618589|NCT00474760|E2|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618590|NCT00474760|E1|Reported Event|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
618591|NCT00474708|B3|Baseline|Total|Total of all reporting groups
618592|NCT00474708|B2|Baseline|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
618593|NCT00474708|B1|Baseline|Venlafaxine XR|75-225 mg per day
618594|NCT00474708|P2|Participant Flow|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
618595|NCT00474708|P1|Participant Flow|Venlafaxine XR|75-225 mg per day
618596|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
618597|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
618598|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
618599|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
618600|NCT00474708|E2|Reported Event|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
618601|NCT00474708|E1|Reported Event|Venlafaxine XR|75-225 mg per day
618602|NCT00474630|B3|Baseline|Total|Total of all reporting groups
618603|NCT00474630|B2|Baseline|Placebo|Placebo
618604|NCT00474630|B1|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618605|NCT00474630|P2|Participant Flow|Placebo|Placebo
618606|NCT00474630|P1|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618607|NCT00474630|O2|Outcome|Placebo|Placebo
618608|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618609|NCT00474630|O2|Outcome|Placebo|Placebo
618610|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618611|NCT00474630|O2|Outcome|Placebo|Placebo
618612|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618613|NCT00474630|O2|Outcome|Placebo|Placebo
618614|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618624|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618625|NCT00474630|O2|Outcome|Placebo|Placebo
618626|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618627|NCT00474630|O2|Outcome|Placebo|Placebo
618628|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618629|NCT00474630|O2|Outcome|Placebo|Placebo
618630|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618631|NCT00474630|O2|Outcome|Placebo|Placebo
618632|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618633|NCT00474630|O2|Outcome|Placebo|Placebo
618634|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618635|NCT00474630|O2|Outcome|Placebo|Placebo
618636|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618637|NCT00474630|O2|Outcome|Placebo|Placebo
618638|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618639|NCT00474630|O2|Outcome|Placebo|Placebo
618640|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618641|NCT00474630|O2|Outcome|Placebo|Placebo
618642|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618643|NCT00474630|O2|Outcome|Placebo|Placebo
618644|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618645|NCT00474630|O2|Outcome|Placebo|Placebo
618646|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618647|NCT00474630|O2|Outcome|Placebo|Placebo
618648|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618649|NCT00474630|O2|Outcome|Placebo|Placebo
618650|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618651|NCT00474630|O2|Outcome|Placebo|Placebo
618652|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618653|NCT00474630|O2|Outcome|Placebo|Placebo
618654|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/ day
618655|NCT00474630|O2|Outcome|Placebo|Placebo
618656|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
618657|NCT00474630|E2|Reported Event|Placebo|Placebo
618658|NCT00474630|E1|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg daily
618659|NCT00474539|B3|Baseline|Total|Total of all reporting groups
618660|NCT00474539|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
618661|NCT00474539|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
618662|NCT00474539|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
618663|NCT00474539|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
618664|NCT00474539|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
618698|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
618665|NCT00474539|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
618666|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
618667|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
618668|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
618669|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
618670|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
618671|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
618672|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
618673|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
618674|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
618675|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
618676|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
618677|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
618678|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
618679|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
618680|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
618681|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
618682|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2)
618683|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
618684|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
618685|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
618686|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
618687|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
618688|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
618689|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
618690|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
618691|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
618692|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
618693|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
618694|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
618695|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
618696|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
618697|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
618699|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
618700|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
618701|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
618702|NCT00474539|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
618703|NCT00474539|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
618704|NCT00474539|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
618705|NCT00474539|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
618706|NCT00474539|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
618707|NCT00474539|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
618708|NCT00474539|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
618709|NCT00474539|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
618710|NCT00474526|B18|Baseline|TOTAL|Total of all reporting groups
618711|NCT00474526|B17|Baseline|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
618712|NCT00474526|B16|Baseline|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
618713|NCT00474526|B15|Baseline|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
618714|NCT00474526|B14|Baseline|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
618715|NCT00474526|B13|Baseline|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618716|NCT00474526|B12|Baseline|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
618717|NCT00474526|B11|Baseline|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618718|NCT00474526|B10|Baseline|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618719|NCT00474526|B9|Baseline|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
619068|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
618720|NCT00474526|B8|Baseline|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618721|NCT00474526|B7|Baseline|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
618722|NCT00474526|B6|Baseline|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
618723|NCT00474526|B5|Baseline|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618724|NCT00474526|B4|Baseline|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618725|NCT00474526|B3|Baseline|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618726|NCT00474526|B2|Baseline|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618727|NCT00474526|B1|Baseline|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618728|NCT00474526|P17|Participant Flow|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
618729|NCT00474526|P16|Participant Flow|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
618730|NCT00474526|P15|Participant Flow|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
618731|NCT00474526|P14|Participant Flow|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
618732|NCT00474526|P13|Participant Flow|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618733|NCT00474526|P12|Participant Flow|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
618734|NCT00474526|P11|Participant Flow|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618735|NCT00474526|P10|Participant Flow|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618736|NCT00474526|P9|Participant Flow|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
618737|NCT00474526|P8|Participant Flow|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618927|NCT00474487|E4|Reported Event|Licensed Polysaccharide Vaccine (56 to 65 Years)|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years)
618738|NCT00474526|P7|Participant Flow|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
618739|NCT00474526|P6|Participant Flow|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
618740|NCT00474526|P5|Participant Flow|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618741|NCT00474526|P4|Participant Flow|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618742|NCT00474526|P3|Participant Flow|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618743|NCT00474526|P2|Participant Flow|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618744|NCT00474526|P1|Participant Flow|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618745|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618746|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618747|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618748|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618749|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
618750|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618751|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
618752|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618753|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
618754|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618755|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
618756|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618757|NCT00474526|O3|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618758|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618759|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618760|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618761|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618762|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618763|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618764|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618765|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618766|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618767|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618768|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618769|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618770|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618771|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618772|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618773|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
619069|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
618774|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618775|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618776|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618777|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618778|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618779|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618780|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618781|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618782|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618783|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618784|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618785|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618786|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618787|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618788|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618789|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618790|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618791|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618792|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
619070|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
618793|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618794|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618795|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618796|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618797|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618798|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618799|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618800|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618801|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618802|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618803|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618804|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618805|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
618806|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618807|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
618808|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618809|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618810|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618811|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618812|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
619071|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
618813|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
618814|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618815|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
618816|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618817|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618818|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618819|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and received,as part of routine infant vaccination schedule, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group US1 was randomized into subgroups US1A and US1B.
618820|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
618821|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
618822|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
618823|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
618824|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
618825|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
618826|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
619072|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
618827|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
618828|NCT00474526|O4|Outcome|LA4 + LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
618829|NCT00474526|O3|Outcome|LA3 + LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled.~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
618830|NCT00474526|O2|Outcome|US2 + US4 (Infant Vaccines Only)|"Groups Infant Vaccines only (US2+US4) pooled~US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A); or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and one dose at 15 months of age (US4B); or one dose of MenACWY at 18 months of age (US4C)."
618831|NCT00474526|O1|Outcome|US1 + US3 (Men ACWY-CRM + Infant Vaccines)|"Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled.~US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B)."
618832|NCT00474526|O4|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
618833|NCT00474526|O3|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618834|NCT00474526|O2|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
618835|NCT00474526|O1|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618836|NCT00474526|O13|Outcome|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
618837|NCT00474526|O12|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
618838|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
618839|NCT00474526|O10|Outcome|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
618840|NCT00474526|O9|Outcome|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
618841|NCT00474526|O8|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618842|NCT00474526|O7|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
618843|NCT00474526|O6|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618844|NCT00474526|O5|Outcome|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
618845|NCT00474526|O4|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
618846|NCT00474526|O3|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618847|NCT00474526|O2|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled.In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618848|NCT00474526|O1|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618849|NCT00474526|O11|Outcome|LA6B + LA6C (Infant Vaccines Only)|"Groups Infant Vaccines only LA6B and LA6C pooled.~Infant Vaccines only (LA6B): LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
618850|NCT00474526|O10|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
618851|NCT00474526|O9|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618852|NCT00474526|O8|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
618853|NCT00474526|O7|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618854|NCT00474526|O6|Outcome|US4B + US4C (Infant Vaccines Only)|"Groups Infant Vaccines only (US4B and US4C) pooled.~Infant Vaccines only (US4B): US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either received one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B); or one dose at 18 months of age (US4C)."
618855|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618856|NCT00474526|O4|Outcome|US2 + US4A (Infant Vaccines Only)|"Groups Infant Vaccines only (US2 and US4A) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age."
618857|NCT00474526|O3|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled. In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618858|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618859|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618860|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
618861|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
618862|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618863|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618864|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618865|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618866|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
618867|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618868|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618869|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
618870|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618871|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618872|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618873|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618874|NCT00474526|O10|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
618875|NCT00474526|O9|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
618876|NCT00474526|O8|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618877|NCT00474526|O7|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618878|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
618879|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618880|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618881|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
618882|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618883|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618884|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
618885|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
618886|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
618887|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
618888|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618889|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
618890|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only )|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
618891|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
618892|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
618893|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
618894|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines )|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
618895|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
618896|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
618897|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
618898|NCT00474526|E6|Reported Event|LA6C|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
618928|NCT00474487|E3|Reported Event|Licensed Conjugate Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years.
618929|NCT00474487|E2|Reported Event|Novartis MenACWY Vaccine (56 to 65 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618899|NCT00474526|E5|Reported Event|LA2+4+6AB|Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).
618900|NCT00474526|E4|Reported Event|LA1+LA3+LA5|"Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled~LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B).~LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received:~Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A)~DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B).~Concomitantly the fourth dose of MenACWY (LA5)."
618901|NCT00474526|E3|Reported Event|US4C|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
618902|NCT00474526|E2|Reported Event|US2+US4A+US4B|"Groups Infant Vaccines only (US2, US4A, and US4B) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)"
618903|NCT00474526|E1|Reported Event|US1+US3|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
618904|NCT00474487|B5|Baseline|Total|Total of all reporting groups
618905|NCT00474487|B4|Baseline|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
618906|NCT00474487|B3|Baseline|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
618907|NCT00474487|B2|Baseline|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
618908|NCT00474487|B1|Baseline|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
618909|NCT00474487|P4|Participant Flow|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
618910|NCT00474487|P3|Participant Flow|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
618911|NCT00474487|P2|Participant Flow|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
618912|NCT00474487|P1|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
618913|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly.
618914|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618915|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
618916|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618917|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
618918|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618919|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
618920|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618921|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
618922|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618923|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
618924|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618925|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
618926|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
633630|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
618930|NCT00474487|E1|Reported Event|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
618931|NCT00474383|B1|Baseline|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618932|NCT00474383|P2|Participant Flow|Arbitarone Acetate (Extension)|Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
618933|NCT00474383|P1|Participant Flow|Abiraterone Acetate (Main Study)|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618934|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618935|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618936|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618937|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618938|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618939|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618940|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618941|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618942|NCT00474383|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
618943|NCT00474266|B5|Baseline|Total|Total of all reporting groups
618944|NCT00474266|B4|Baseline|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618945|NCT00474266|B3|Baseline|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618946|NCT00474266|B2|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618947|NCT00474266|B1|Baseline|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618948|NCT00474266|P4|Participant Flow|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618949|NCT00474266|P3|Participant Flow|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618950|NCT00474266|P2|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618951|NCT00474266|P1|Participant Flow|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618952|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618953|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618954|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618955|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618956|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619073|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
618957|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618958|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618959|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618960|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618961|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618962|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618963|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618964|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618965|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618966|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618967|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618968|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618969|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618970|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618971|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618972|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618973|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618974|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618975|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618976|NCT00474266|O3|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618977|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618978|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618979|NCT00474266|O2|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618980|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618981|NCT00474266|O2|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618982|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618983|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618984|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618985|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618986|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618987|NCT00474266|O2|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618988|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618989|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618990|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619066|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
618991|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618992|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618993|NCT00474266|O2|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618994|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618995|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618996|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618997|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
618998|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
618999|NCT00474266|O2|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619000|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619001|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619002|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619003|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619004|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619005|NCT00474266|O4|Outcome|Pooled Group|Subjects from Nimenrix + Priorix-Tetra Group and subjects from Nimenrix Group
619006|NCT00474266|O3|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619007|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619008|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619009|NCT00474266|O4|Outcome|Pooled Group|Subjects from Nimenrix + Priorix-Tetra Group and subjects from Nimenrix Group
619010|NCT00474266|O3|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619011|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619012|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619013|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619014|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619015|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619016|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619017|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619018|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619019|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619020|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619021|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619022|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619023|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619024|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619025|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619067|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
619026|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619027|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619028|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619029|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619030|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619031|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619032|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619033|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619034|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619035|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619036|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619037|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619038|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619039|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619040|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619041|NCT00474266|O4|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619042|NCT00474266|O3|Outcome|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619043|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619044|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619045|NCT00474266|O3|Outcome|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619046|NCT00474266|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619047|NCT00474266|O1|Outcome|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619048|NCT00474266|E4|Reported Event|Priorix-Tetra Group|Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, one dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619049|NCT00474266|E3|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619050|NCT00474266|E2|Reported Event|Meningitec Group|Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.
619051|NCT00474266|E1|Reported Event|Nimenrix + Priorix-Tetra Group|Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.
619052|NCT00474240|B7|Baseline|Total|Total of all reporting groups
619053|NCT00474240|B6|Baseline|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
619054|NCT00474240|B5|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
619055|NCT00474240|B4|Baseline|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
619056|NCT00474240|B3|Baseline|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
619057|NCT00474240|B2|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
619058|NCT00474240|B1|Baseline|Placebo|Placebo capsule taken orally once daily
619059|NCT00474240|P6|Participant Flow|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
619060|NCT00474240|P5|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
619061|NCT00474240|P4|Participant Flow|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
619062|NCT00474240|P3|Participant Flow|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
619063|NCT00474240|P2|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
619064|NCT00474240|P1|Participant Flow|Placebo|Placebo capsule taken orally once daily
619065|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
633631|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
619074|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
619075|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
619076|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
619077|NCT00474240|E6|Reported Event|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
619078|NCT00474240|E5|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
619079|NCT00474240|E4|Reported Event|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
619080|NCT00474240|E3|Reported Event|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
619081|NCT00474240|E2|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
619082|NCT00474240|E1|Reported Event|Placebo|Placebo capsule taken orally once daily
619083|NCT00474201|B1|Baseline|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
619084|NCT00474201|P1|Participant Flow|Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected to determine gemfibrozil plasma concentrations. These plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameter values such as area under the concentration vs. time curve (AUC). Gemfibrozil PK parameter values were then compared before- and after lopinavir-ritonavir administration.
619085|NCT00474201|O2|Outcome|Gemfibrozil + Lopinavir-ritonavir|After receiving lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days, subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest.
619086|NCT00474201|O1|Outcome|Gemfibrozil Alone (Control Group)|"Subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest. After completing participation in this control group, each subject crossed over to received lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days. Therefore, each subject served as their own control. Hence there were two groups of data analyzed, but each group consisted of the same subjects (tested under different conditions)."
619087|NCT00474201|E1|Reported Event|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
619088|NCT00474188|B1|Baseline|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
619089|NCT00474188|P1|Participant Flow|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
619090|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
619091|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
619092|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
619093|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
619094|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
619095|NCT00474175|B4|Baseline|Total|Total of all reporting groups
619096|NCT00474175|B3|Baseline|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619097|NCT00474175|B2|Baseline|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619098|NCT00474175|B1|Baseline|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619099|NCT00474175|P3|Participant Flow|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619100|NCT00474175|P2|Participant Flow|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619101|NCT00474175|P1|Participant Flow|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619102|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619103|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619104|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
633632|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
619105|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619106|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619107|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619108|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619109|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619110|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619111|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619112|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619113|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619114|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619115|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619116|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619117|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619118|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619119|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619120|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619121|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619122|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619123|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619124|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619125|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619126|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619127|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619128|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619129|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619130|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619131|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619132|NCT00474175|E3|Reported Event|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
619133|NCT00474175|E2|Reported Event|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
619134|NCT00474175|E1|Reported Event|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
619135|NCT00474123|B3|Baseline|Total|Total of all reporting groups
619136|NCT00474123|B2|Baseline|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619137|NCT00474123|B1|Baseline|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619138|NCT00474123|P2|Participant Flow|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619139|NCT00474123|P1|Participant Flow|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619140|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619141|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619142|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619143|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619144|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619145|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619146|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619147|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619148|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619149|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619150|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619151|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619152|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619153|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619154|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619155|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619156|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619157|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619158|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619159|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619160|NCT00474123|E2|Reported Event|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
619161|NCT00474123|E1|Reported Event|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
619162|NCT00474058|B3|Baseline|Total|Total of all reporting groups
619163|NCT00474058|B2|Baseline|Placebo|Placebo transdermal patch
619164|NCT00474058|B1|Baseline|Rotigotine|Rotigotine transdermal patch
619165|NCT00474058|P2|Participant Flow|Placebo|Placebo transdermal patch
619166|NCT00474058|P1|Participant Flow|Rotigotine|Rotigotine transdermal patch
619167|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
619168|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
619169|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
619170|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
619171|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
619172|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
619173|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
619174|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
619175|NCT00474058|E2|Reported Event|Placebo|Placebo transdermal patch
619176|NCT00474058|E1|Reported Event|Rotigotine|Rotigotine transdermal patch
619177|NCT00474045|B3|Baseline|Total|Total of all reporting groups
619178|NCT00474045|B2|Baseline|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619179|NCT00474045|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619180|NCT00474045|P2|Participant Flow|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619181|NCT00474045|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619182|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619183|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619184|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619185|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619186|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619468|NCT00473642|B2|Baseline|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
619187|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619188|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619189|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619190|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619191|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619192|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619193|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619194|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619195|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619196|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619197|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619198|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619199|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619343|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
619200|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619201|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619202|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619203|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619204|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619205|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619206|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619207|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619208|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619209|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619210|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619211|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619212|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619344|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
619213|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619214|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619215|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619216|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619217|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619218|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619219|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619220|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619221|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619222|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619223|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619224|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619225|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619345|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
619226|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619227|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619228|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619229|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619230|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619231|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619232|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619233|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619234|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619235|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619236|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619237|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619238|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619346|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
619239|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619240|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619241|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619242|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619243|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619244|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619245|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619246|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619247|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619248|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619249|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619250|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619251|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619347|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
619252|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619253|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619254|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619255|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619256|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619257|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619258|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619259|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619260|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619261|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619262|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619263|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619264|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619348|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
619265|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619266|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619267|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619268|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619269|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619270|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619271|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619272|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619273|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619274|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619275|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619276|NCT00474045|E2|Reported Event|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619277|NCT00474045|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
619278|NCT00473889|B3|Baseline|Total|Total of all reporting groups
619469|NCT00473642|B1|Baseline|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
619279|NCT00473889|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619280|NCT00473889|B1|Baseline|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619281|NCT00473889|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619282|NCT00473889|P1|Participant Flow|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619283|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619284|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619285|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619286|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619287|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619288|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619289|NCT00473889|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619290|NCT00473889|E1|Reported Event|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
619291|NCT00473876|B3|Baseline|Total|Total of all reporting groups
619292|NCT00473876|B2|Baseline|Placebo|Matched Placebo for 4 months
619293|NCT00473876|B1|Baseline|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
619294|NCT00473876|P2|Participant Flow|Placebo|Matched Placebo for 4 months
619295|NCT00473876|P1|Participant Flow|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
619296|NCT00473876|O2|Outcome|Placebo|Impact of placebo on VE/VCO2 slope.
619297|NCT00473876|O1|Outcome|Metformin Arm|Assess impact of metformin on submaximal exercise parameters- VE/VCO2 slope (pre-specified end point). The mean VE/VCO2 difference was compared between baseline and after 4 months of metformin.
619298|NCT00473876|O2|Outcome|Placebo|Peak VO2 mean difference between baseline and after 4 months of placebo
619299|NCT00473876|O1|Outcome|Metformin Arm|Peak VO2 mean difference between baseline and after 4 months of metformin was analysed
619300|NCT00473876|E2|Reported Event|Placebo|Matched Placebo for 4 months
619301|NCT00473876|E1|Reported Event|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
619302|NCT00473837|B3|Baseline|Total|Total of all reporting groups
619303|NCT00473837|B2|Baseline|Control|Subjects initially treated with Co-artemether or Chloroquine & Sulphadoxine/Pyrimathamine, and then continued on weekly placebo till day 90
619304|NCT00473837|B1|Baseline|Treatment|Subjects initially treated with Co-artemether or Chloroquine &Sulphadoxine/Pyrimathamine, and then continued on weekly chloroquine till day 90
619305|NCT00473837|P2|Participant Flow|Control|Subjects initially treated with Co-artemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly placebo till day 90.
619306|NCT00473837|P1|Participant Flow|Treatment|Subjects initially treated with Corartemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly chloroquine till day 90.
619349|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
619307|NCT00473837|O2|Outcome|Control|"Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90~Placebo: The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul"
619308|NCT00473837|O1|Outcome|Treatment|"Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90~Chloroquine: This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days"
619309|NCT00473837|E2|Reported Event|Control|Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
619310|NCT00473837|E1|Reported Event|Treatment|Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
619311|NCT00473824|B3|Baseline|Total|Total of all reporting groups
619312|NCT00473824|B2|Baseline|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
619313|NCT00473824|B1|Baseline|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
619314|NCT00473824|P2|Participant Flow|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
619315|NCT00473824|P1|Participant Flow|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
619316|NCT00473824|O2|Outcome|No Civacir (Control)|Observation on standard site specific routine post-tranplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%. Standard post-tranplant therapy includes immunosuppressive agents.
619317|NCT00473824|O1|Outcome|Civacir Treatment Arm|Subjects received Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, in addition to their standard site specific routine post-tranplant immunosuppressant therapy.
619318|NCT00473824|E2|Reported Event|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
619319|NCT00473824|E1|Reported Event|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
619320|NCT00473746|B6|Baseline|Total|Total of all reporting groups
619321|NCT00473746|B5|Baseline|Phase 2 1000 MG/DAY|Abiraterone acetate
619322|NCT00473746|B4|Baseline|Phase 1 1000 MG/DAY|Abiraterone acetate
619323|NCT00473746|B3|Baseline|Phase 1 750 MG/DAY|Abiraterone acetate
619324|NCT00473746|B2|Baseline|Phase 1 500 MG/DAY|Abiraterone acetate
619325|NCT00473746|B1|Baseline|Phase 1 250 MG/DAY|Abiraterone acetate
619326|NCT00473746|P5|Participant Flow|Phase 2 1000 MG/DAY|Abiraterone acetate
619327|NCT00473746|P4|Participant Flow|Phase 1 1000 MG/DAY|Abiraterone acetate
619328|NCT00473746|P3|Participant Flow|Phase 1 750 MG/DAY|Abiraterone acetate
619329|NCT00473746|P2|Participant Flow|Phase 1 500 MG/DAY|Abiraterone acetate
619330|NCT00473746|P1|Participant Flow|Phase 1 250 MG/DAY|Abiraterone acetate
619331|NCT00473746|O1|Outcome|Phase II Dose Treatment|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
619332|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619333|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619334|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619335|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619336|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619337|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619338|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619339|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
619340|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
619341|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
619342|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
619458|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619350|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
619351|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
619352|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
619353|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
619354|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
619355|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
619356|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
619357|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
619358|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
619359|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
619360|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
619361|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
619362|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
619363|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
619364|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
619365|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
619366|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
619367|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
619368|NCT00473746|O1|Outcome|Phase I Dose Escalation|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
619369|NCT00473746|E5|Reported Event|Phase 2 1000 MG/DAY|Abiraterone acetate
619370|NCT00473746|E4|Reported Event|Phase 1 1000 MG/DAY|Abiraterone acetate
619371|NCT00473746|E3|Reported Event|Phase 1 750 MG/DAY|Abiraterone acetate
619372|NCT00473746|E2|Reported Event|Phase 1 500 MG/DAY|Abiraterone acetate
619373|NCT00473746|E1|Reported Event|Phase 1 250 MG/DAY|Abiraterone acetate
619374|NCT00473668|B4|Baseline|Total|Total of all reporting groups
619375|NCT00473668|B3|Baseline|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619376|NCT00473668|B2|Baseline|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619377|NCT00473668|B1|Baseline|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619378|NCT00473668|P3|Participant Flow|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619379|NCT00473668|P2|Participant Flow|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619380|NCT00473668|P1|Participant Flow|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619381|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619382|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619383|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619384|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619459|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619460|NCT00473655|O3|Outcome|Placebo|Placebo
619385|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619386|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619387|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619388|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619389|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619390|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619391|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619392|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619393|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619394|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619395|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619396|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619397|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619398|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619399|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619400|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619401|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619402|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619403|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619404|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619405|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619406|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619407|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619408|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619409|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619410|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619461|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619462|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619463|NCT00473655|E3|Reported Event|Placebo|Placebo
619411|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619412|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619413|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619414|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619415|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619416|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619417|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619418|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619419|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619420|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619421|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619422|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619423|NCT00473668|O3|Outcome|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619424|NCT00473668|O2|Outcome|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619425|NCT00473668|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619426|NCT00473668|E3|Reported Event|Tritanrix-HepB/Hiberix HD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619427|NCT00473668|E2|Reported Event|Tritanrix-HepB/Hiberix LD Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619428|NCT00473668|E1|Reported Event|Tritanrix-HepB/Hiberix Kft. Group|Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.
619429|NCT00473655|B4|Baseline|Total|Total of all reporting groups
619430|NCT00473655|B3|Baseline|Placebo|Placebo
619431|NCT00473655|B2|Baseline|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619432|NCT00473655|B1|Baseline|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619433|NCT00473655|P3|Participant Flow|Placebo|Placebo
619434|NCT00473655|P2|Participant Flow|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619435|NCT00473655|P1|Participant Flow|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619436|NCT00473655|O3|Outcome|Placebo|Placebo
619437|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619438|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619439|NCT00473655|O3|Outcome|Placebo|Placebo
619440|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619441|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619442|NCT00473655|O3|Outcome|Placebo|Placebo
619443|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619444|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619445|NCT00473655|O3|Outcome|Placebo|Placebo
619446|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619447|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619448|NCT00473655|O3|Outcome|Placebo|Placebo
619449|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619450|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619451|NCT00473655|O3|Outcome|Placebo|Placebo
619452|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619453|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619454|NCT00473655|O3|Outcome|Placebo|Placebo
619455|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
619456|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
619457|NCT00473655|O3|Outcome|Placebo|Placebo
619471|NCT00473642|P2|Participant Flow|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
619472|NCT00473642|P1|Participant Flow|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
619473|NCT00473642|O3|Outcome|Ranibizumab|Ranibizumab monotherapy
619474|NCT00473642|O2|Outcome|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
619475|NCT00473642|O1|Outcome|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
619476|NCT00473642|E3|Reported Event|Ranibizumab|Ranibizumab monotherapy
619477|NCT00473642|E2|Reported Event|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
619478|NCT00473642|E1|Reported Event|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
619479|NCT00473590|B3|Baseline|Total|Total of all reporting groups
619480|NCT00473590|B2|Baseline|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619481|NCT00473590|B1|Baseline|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619482|NCT00473590|P2|Participant Flow|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619483|NCT00473590|P1|Participant Flow|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619484|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619485|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619486|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619487|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619488|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619489|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619490|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619491|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619492|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619493|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619494|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619495|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619496|NCT00473590|E2|Reported Event|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
619497|NCT00473590|E1|Reported Event|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
619498|NCT00473564|B1|Baseline|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
619499|NCT00473564|P1|Participant Flow|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
619500|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
619501|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
619502|NCT00473564|E1|Reported Event|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
619503|NCT00473512|B6|Baseline|Total|Total of all reporting groups
619504|NCT00473512|B5|Baseline|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619505|NCT00473512|B4|Baseline|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619506|NCT00473512|B3|Baseline|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619507|NCT00473512|B2|Baseline|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619508|NCT00473512|B1|Baseline|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619509|NCT00473512|P5|Participant Flow|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619510|NCT00473512|P4|Participant Flow|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619511|NCT00473512|P3|Participant Flow|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619512|NCT00473512|P2|Participant Flow|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619513|NCT00473512|P1|Participant Flow|250 mg/Day|Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619514|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619515|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619580|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619516|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619517|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619518|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619519|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619520|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619521|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619522|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619523|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619524|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619525|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619526|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619527|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619528|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619529|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619530|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619531|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619532|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619533|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619534|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619535|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619536|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619537|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619538|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619539|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619540|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619541|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619542|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619543|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619544|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619545|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619546|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619547|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619548|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
619549|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619550|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619551|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619552|NCT00473512|O5|Outcome|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619553|NCT00473512|O4|Outcome|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619554|NCT00473512|O3|Outcome|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619555|NCT00473512|O2|Outcome|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619556|NCT00473512|O1|Outcome|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619557|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619558|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619559|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619560|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619561|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619562|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619563|NCT00473512|O2|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
619564|NCT00473512|O1|Outcome|1000 mg AA Monotherapy|Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
619565|NCT00473512|E5|Reported Event|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619566|NCT00473512|E4|Reported Event|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619567|NCT00473512|E3|Reported Event|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619568|NCT00473512|E2|Reported Event|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619569|NCT00473512|E1|Reported Event|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
619570|NCT00473434|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619571|NCT00473434|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619572|NCT00473434|O9|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619573|NCT00473434|O8|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619574|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619575|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619576|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619577|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619578|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619579|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
633633|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
619581|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619582|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619583|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619584|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619585|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619586|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619587|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619588|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619589|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619590|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619591|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619592|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619593|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619594|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619595|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619596|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619597|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619598|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619599|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619600|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619601|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619602|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619603|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619604|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619605|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619606|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619607|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619608|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619609|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619610|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619611|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619612|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619613|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619614|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619615|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619616|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619617|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619618|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619619|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619620|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619621|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619622|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619623|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619624|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619625|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619626|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619627|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619628|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619629|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619630|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619631|NCT00473434|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
619632|NCT00473382|B4|Baseline|Total|Total of all reporting groups
619633|NCT00473382|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
619634|NCT00473382|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619635|NCT00473382|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
620431|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
619636|NCT00473382|P3|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619637|NCT00473382|P2|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619638|NCT00473382|P1|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619639|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619640|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619641|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619642|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619643|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619644|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619645|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619646|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619647|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619648|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619649|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
620683|NCT00469391|E2|Reported Event|Sham Control|3 subjects withdrew before the procedure. N=26 for the ITT population.
619650|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619651|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619652|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619653|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619654|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619655|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
619656|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
619657|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
619658|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619659|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619660|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619661|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619662|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619663|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619664|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive Ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619665|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619666|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619667|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619668|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619669|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
633634|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
619670|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619671|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619672|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619673|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619674|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619675|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619676|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619677|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619678|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619679|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619680|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619681|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619682|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
619683|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
619684|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
619759|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619685|NCT00473382|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
619686|NCT00473382|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
619687|NCT00473382|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
619688|NCT00473382|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
619689|NCT00473382|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
619690|NCT00473382|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
619691|NCT00473382|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
619692|NCT00473330|B4|Baseline|Total|Total of all reporting groups
619693|NCT00473330|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
619694|NCT00473330|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619695|NCT00473330|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619696|NCT00473330|P3|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619697|NCT00473330|P2|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619698|NCT00473330|P1|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
619699|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619700|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619701|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619702|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619760|NCT00473265|E1|Reported Event|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619761|NCT00473083|B4|Baseline|Total|Total of all reporting groups
619703|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619704|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619705|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619706|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619707|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619708|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619709|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619710|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619711|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619712|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619713|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
619714|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
619715|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
619716|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
619717|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
619718|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619719|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619720|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
619721|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
619810|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
619811|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
619812|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619813|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
619814|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
633635|NCT00439725|B3|Baseline|Total|Total of all reporting groups
619722|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619723|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619724|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619725|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619726|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
619727|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619728|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
619729|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
619730|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619731|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619732|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619733|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619734|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619735|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619736|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619815|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619816|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
619817|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
619737|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619738|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619739|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
619740|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619741|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
619742|NCT00473330|O3|Outcome|Sham Injection|Patients received a sham intravitreal injection monthly for 24 months.
619743|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
619744|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
619745|NCT00473330|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
619746|NCT00473330|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
619747|NCT00473330|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
619748|NCT00473330|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
619749|NCT00473330|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
619750|NCT00473330|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
619751|NCT00473330|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
619752|NCT00473265|B1|Baseline|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619753|NCT00473265|P1|Participant Flow|PTH1-84|participants received PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619754|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619755|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619756|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619757|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619758|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
619762|NCT00473083|B3|Baseline|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619763|NCT00473083|B2|Baseline|Arm 2: Reactive Treatmen|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619764|NCT00473083|B1|Baseline|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619765|NCT00473083|P3|Participant Flow|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619766|NCT00473083|P2|Participant Flow|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619767|NCT00473083|P1|Participant Flow|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619768|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619769|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619770|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619818|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619819|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
619771|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619772|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619773|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619774|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619775|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619776|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619777|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619778|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619779|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619820|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
619821|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619822|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
619780|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619781|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619782|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619783|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619784|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619785|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619786|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619787|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619788|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619823|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
619824|NCT00472797|O1|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619825|NCT00472797|E3|Reported Event|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619826|NCT00472797|E2|Reported Event|Titrated|New formulation of rebif
619789|NCT00473083|E3|Reported Event|Arm 3: Treat Only if Grade 3 Rash Occurs|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
619790|NCT00473083|E2|Reported Event|Arm 2: Treat Only Upon Initiation of Rash|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
619791|NCT00473083|E1|Reported Event|Arm 1: Rash Prevention|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
619792|NCT00472849|B3|Baseline|Total|Total of all reporting groups
619793|NCT00472849|B2|Baseline|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
619794|NCT00472849|B1|Baseline|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
619795|NCT00472849|P2|Participant Flow|OFAR (Phase II)|Oxaliplatin 25 mg/m^2 IV per day (Phase I MTD) on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
619796|NCT00472849|P1|Participant Flow|OFAR (Phase I)|Oxaliplatin starting dose 30 mg/m^2/day over 2 hours on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily intravenous (IV) over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
619797|NCT00472849|O1|Outcome|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
619798|NCT00472849|O1|Outcome|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
619799|NCT00472849|E2|Reported Event|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
619800|NCT00472849|E1|Reported Event|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
619801|NCT00472797|B3|Baseline|Total|Total of all reporting groups
619802|NCT00472797|B2|Baseline|New Formulation of Rebif - Titrated|
619803|NCT00472797|B1|Baseline|New Formulation of Rebif - Non-Titrated|
619804|NCT00472797|P2|Participant Flow|New Formulation of Rebif - Titrated|The new frmulation of rebif is not approved and under investigation in the US
619805|NCT00472797|P1|Participant Flow|New Formulation of Rebif - Non-Titrated|The new formulation of rebif is not approved and under investigation in the US
619806|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619807|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
619808|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
619809|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
619829|NCT00472732|B2|Baseline|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
619830|NCT00472732|B1|Baseline|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
619831|NCT00472732|P2|Participant Flow|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
619832|NCT00472732|P1|Participant Flow|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
619833|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
619834|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
619835|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
619836|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
619837|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
619838|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
619839|NCT00472732|E2|Reported Event|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
619840|NCT00472732|E1|Reported Event|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
619841|NCT00472641|B1|Baseline|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
619842|NCT00472641|P1|Participant Flow|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
619843|NCT00472641|O1|Outcome|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
619844|NCT00472641|O1|Outcome|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
619845|NCT00472641|E1|Reported Event|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
619846|NCT00472576|B3|Baseline|Total|Total of all reporting groups
619847|NCT00472576|B2|Baseline|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
619848|NCT00472576|B1|Baseline|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
619849|NCT00472576|P2|Participant Flow|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
619850|NCT00472576|P1|Participant Flow|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
619851|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
619852|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
619853|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
619854|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
619855|NCT00472576|E2|Reported Event|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
619856|NCT00472576|E1|Reported Event|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
619857|NCT00472446|B5|Baseline|Total|Total of all reporting groups
619858|NCT00472446|B4|Baseline|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619859|NCT00472446|B3|Baseline|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619860|NCT00472446|B2|Baseline|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619861|NCT00472446|B1|Baseline|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619862|NCT00472446|P4|Participant Flow|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
620738|NCT00469079|O1|Outcome|Medicinal Nicotine|Nicotine gum or nicotine lozenge
619863|NCT00472446|P3|Participant Flow|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619864|NCT00472446|P2|Participant Flow|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619865|NCT00472446|P1|Participant Flow|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619866|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619867|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619868|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619869|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619870|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619871|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619872|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619873|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619874|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619875|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619876|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619877|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619878|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619879|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619880|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619881|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619882|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619883|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619884|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619885|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619886|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619887|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619888|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619889|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619890|NCT00472446|E4|Reported Event|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619891|NCT00472446|E3|Reported Event|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619892|NCT00472446|E2|Reported Event|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619893|NCT00472446|E1|Reported Event|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
619894|NCT00472420|B1|Baseline|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
619895|NCT00472420|P1|Participant Flow|Rituximab Plus (+) Chemotherapy|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or orally (PO), on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, every 12 hours (q12h) on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
619896|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
619897|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
619919|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619920|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619921|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619898|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
619899|NCT00472420|E1|Reported Event|Rituximab + Chemotherapy|Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses).
619900|NCT00472303|B3|Baseline|Total|Total of all reporting groups
619901|NCT00472303|B2|Baseline|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619902|NCT00472303|B1|Baseline|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619903|NCT00472303|P3|Participant Flow|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo received 100 mg tapentadol prolonged release (PR) twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619904|NCT00472303|P2|Participant Flow|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619905|NCT00472303|P1|Participant Flow|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619906|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619907|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619908|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619909|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619910|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619911|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619912|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619913|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619914|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
619915|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619916|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619917|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619918|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase
619922|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619923|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619924|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619925|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619926|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619927|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619928|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619929|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619930|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619931|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619932|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619933|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619934|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619935|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619936|NCT00472303|O1|Outcome|Tapentadol Extended Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619937|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619938|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619939|NCT00472303|O5|Outcome|Morphine Controlled Release Maintenance Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619940|NCT00472303|O4|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily in the titration phase. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
619941|NCT00472303|O3|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619942|NCT00472303|O2|Outcome|Morphine Controlled Release Titration Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses
619943|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619944|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
620081|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
619945|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619946|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619947|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619948|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619949|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619950|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619951|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619952|NCT00472303|O1|Outcome|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619953|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619954|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619955|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619956|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619957|NCT00472303|O1|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619958|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619959|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619960|NCT00472303|O2|Outcome|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619961|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
619962|NCT00472303|E5|Reported Event|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. The dose that was effective at the end of the Titration Phase.
619963|NCT00472303|E4|Reported Event|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
619964|NCT00472303|E3|Reported Event|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. The participant continued at the dose that was effective at the end of the Titration Phase.
619965|NCT00472303|E2|Reported Event|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619966|NCT00472303|E1|Reported Event|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
619967|NCT00472290|B1|Baseline|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619968|NCT00472290|P1|Participant Flow|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
620739|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
619969|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619970|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619971|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619972|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619973|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619974|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619975|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
619976|NCT00472290|E1|Reported Event|Romiplostim|
619977|NCT00472199|B3|Baseline|Total|Total of all reporting groups
619978|NCT00472199|B2|Baseline|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619979|NCT00472199|B1|Baseline|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619980|NCT00472199|P2|Participant Flow|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619981|NCT00472199|P1|Participant Flow|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619982|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619983|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619984|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619985|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619986|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619987|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619988|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619989|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619990|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619991|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619992|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620740|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
619993|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619994|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619995|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619996|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619997|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619998|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
619999|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620000|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620001|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620002|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620003|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620004|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620005|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620006|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620007|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620008|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620009|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620010|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620011|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620012|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620013|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
634802|NCT00437073|B3|Baseline|Total|Total of all reporting groups
620014|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620015|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620016|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620017|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620018|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620019|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620020|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620021|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620022|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620023|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620024|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620025|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620026|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620027|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620028|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620029|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620030|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620031|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620032|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620033|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620034|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620082|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
620035|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620036|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620037|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620038|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620039|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620040|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620041|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620042|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620043|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620044|NCT00472199|E2|Reported Event|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620045|NCT00472199|E1|Reported Event|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
620046|NCT00472082|B1|Baseline|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
620047|NCT00472082|P1|Participant Flow|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
620048|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
620083|NCT00472030|E2|Reported Event|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
620084|NCT00472030|E1|Reported Event|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
620085|NCT00471822|B1|Baseline|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620390|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620049|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
620050|NCT00472082|E1|Reported Event|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
620051|NCT00472056|B5|Baseline|Total|Total of all reporting groups
620052|NCT00472056|B4|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
620053|NCT00472056|B3|Baseline|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
620054|NCT00472056|B2|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
620055|NCT00472056|B1|Baseline|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
620056|NCT00472056|P4|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
620057|NCT00472056|P3|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
620058|NCT00472056|P2|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
620059|NCT00472056|P1|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
620060|NCT00472056|O2|Outcome|High Dose Rituximab|High dose arm: Rituximab 1000mg/m^2 intravenous on days +1 and +8 after stem cell infusion
620061|NCT00472056|O1|Outcome|Standard Dose Rituximab|Standard dose arm: Rituximab 375 mg/m^2 intravenous on days +1 and +8 after stem cell infusion.
620062|NCT00472056|E4|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
620063|NCT00472056|E3|Reported Event|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
620064|NCT00472056|E2|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
620065|NCT00472056|E1|Reported Event|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
620066|NCT00472030|B3|Baseline|Total|Total of all reporting groups
620067|NCT00472030|B2|Baseline|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
620068|NCT00472030|B1|Baseline|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
620069|NCT00472030|P2|Participant Flow|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
620070|NCT00472030|P1|Participant Flow|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
620071|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
620072|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
620073|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
620074|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
620075|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
620076|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
620077|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Research subjects enrolled to the Omalizumab treatment arm will be treated with Omalizumab on Day 1 and at Week 2,4,6,8,10,12,& 14.
620078|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
620079|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with Omalizumab on Day 1, Week 2,4,6,8,10,12 and 14.
620080|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
620741|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
620086|NCT00471822|P1|Participant Flow|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620087|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620088|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620089|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620090|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620091|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620092|NCT00471822|E1|Reported Event|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
620093|NCT00471718|B1|Baseline|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
620094|NCT00471718|P1|Participant Flow|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
620095|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
620096|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
620097|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
620098|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
620099|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Duration of overall response from time measurements are met for CR or PR until date that recurrence or PD is objectively documented
620100|NCT00471718|O1|Outcome|ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
620101|NCT00471718|E1|Reported Event|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
620102|NCT00471705|B4|Baseline|Total|Total of all reporting groups
620103|NCT00471705|B3|Baseline|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
620104|NCT00471705|B2|Baseline|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
620105|NCT00471705|B1|Baseline|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
620106|NCT00471705|P3|Participant Flow|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
620107|NCT00471705|P2|Participant Flow|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
620108|NCT00471705|P1|Participant Flow|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
620109|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
620110|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
620111|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
620112|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
620113|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
620114|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
620115|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
620116|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
620117|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
620118|NCT00471705|E3|Reported Event|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
620119|NCT00471705|E2|Reported Event|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
620120|NCT00471705|E1|Reported Event|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
620121|NCT00471536|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620122|NCT00471536|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620123|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620124|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620796|NCT00468858|O14|Outcome|DEN-2, F19, S+|Antibody DEN-2, Group F19, Pre-vaccination status = S+
620125|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620126|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620127|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620128|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620129|NCT00471536|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
620130|NCT00471497|B4|Baseline|Total|Total of all reporting groups
620131|NCT00471497|B3|Baseline|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620132|NCT00471497|B2|Baseline|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620133|NCT00471497|B1|Baseline|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
620134|NCT00471497|P3|Participant Flow|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620135|NCT00471497|P2|Participant Flow|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620136|NCT00471497|P1|Participant Flow|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
620137|NCT00471497|O3|Outcome|Nilotinib 400mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620181|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620138|NCT00471497|O2|Outcome|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620139|NCT00471497|O1|Outcome|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
620140|NCT00471497|E3|Reported Event|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620141|NCT00471497|E2|Reported Event|Nilotinib 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
620142|NCT00471497|E1|Reported Event|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
620143|NCT00471445|B3|Baseline|Total|Total of all reporting groups
620144|NCT00471445|B2|Baseline|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
620145|NCT00471445|B1|Baseline|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
620146|NCT00471445|P2|Participant Flow|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
620147|NCT00471445|P1|Participant Flow|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
620148|NCT00471445|O2|Outcome|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
620149|NCT00471445|O1|Outcome|Ketamine/Amitriptyline NP-H Cream|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
620150|NCT00471445|E2|Reported Event|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
620151|NCT00471445|E1|Reported Event|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
620152|NCT00471380|B1|Baseline|Overall Study Population|
620153|NCT00471380|P2|Participant Flow|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
620154|NCT00471380|P1|Participant Flow|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
620211|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620155|NCT00471380|O2|Outcome|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
620156|NCT00471380|O1|Outcome|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
620157|NCT00471380|E2|Reported Event|Treatment B|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
620158|NCT00471380|E1|Reported Event|Treatment A|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.).
620159|NCT00471354|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620160|NCT00471354|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620161|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620162|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620163|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620164|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620165|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620166|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620167|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620168|NCT00471354|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
620169|NCT00471328|B3|Baseline|Total|Total of all reporting groups
620170|NCT00471328|B2|Baseline|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620171|NCT00471328|B1|Baseline|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
620172|NCT00471328|P2|Participant Flow|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620173|NCT00471328|P1|Participant Flow|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
620174|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620175|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620176|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
620177|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620178|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620179|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
620180|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620182|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620183|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
620184|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620185|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
620186|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
620187|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
620188|NCT00471328|E3|Reported Event|Crossover Nilotinib Therapy|All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression were included in safety assessment.
620189|NCT00471328|E2|Reported Event|Control(Core + Extension)|Patients randomized to control arm, Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose before the study or at the dose of the investigator’s choice. The safety is assessed using these patient’s data from both core and extension phase of the study.
620190|NCT00471328|E1|Reported Event|Nilotinib(Core +Extension)|Patients randomized to 400 mg Nilotinib which was taken orally twice daily. The safety is assessed using these patient’s data from both core and extension phase of the study.
620191|NCT00471315|B1|Baseline|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
620192|NCT00471315|P1|Participant Flow|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
620193|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
620194|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
620195|NCT00471315|E1|Reported Event|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
620196|NCT00471276|B1|Baseline|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620197|NCT00471276|P1|Participant Flow|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620198|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620199|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620200|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620201|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620202|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620203|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620204|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620205|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620206|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620207|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620208|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620209|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620210|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620797|NCT00468858|O13|Outcome|DEN-2, F19, S-|Antibody DEN-2, Group F19, Pre-vaccination status = S-
620212|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620213|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620214|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620215|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620216|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620217|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620218|NCT00471276|E1|Reported Event|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
620219|NCT00471237|B8|Baseline|Total|Total of all reporting groups
620220|NCT00471237|B7|Baseline|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620221|NCT00471237|B6|Baseline|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620222|NCT00471237|B5|Baseline|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620223|NCT00471237|B4|Baseline|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620224|NCT00471237|B3|Baseline|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620225|NCT00471237|B2|Baseline|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620226|NCT00471237|B1|Baseline|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620227|NCT00471237|P7|Participant Flow|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 microgram (mcg), subcutaneous (SC) injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620228|NCT00471237|P6|Participant Flow|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620229|NCT00471237|P5|Participant Flow|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620230|NCT00471237|P4|Participant Flow|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620231|NCT00471237|P3|Participant Flow|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620232|NCT00471237|P2|Participant Flow|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620233|NCT00471237|P1|Participant Flow|Placebo|Participants received matching placebo once daily (OD) (matching to ronacaleret tablet) and matching placebo once weekly (OW) (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 milligrams (mg) and vitamin D, at least 400 international units (IU), OD in the evening as dietary supplements throughout the study.
620234|NCT00471237|O4|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620384|NCT00471146|P1|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620235|NCT00471237|O3|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620236|NCT00471237|O2|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620237|NCT00471237|O1|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620238|NCT00471237|O4|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620239|NCT00471237|O3|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620240|NCT00471237|O2|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620241|NCT00471237|O1|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620242|NCT00471237|O4|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620243|NCT00471237|O3|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620244|NCT00471237|O2|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620245|NCT00471237|O1|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620246|NCT00471237|O4|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620247|NCT00471237|O3|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620248|NCT00471237|O2|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620249|NCT00471237|O1|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620250|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620251|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620252|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620253|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620254|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620255|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620430|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
620256|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620257|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620258|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620259|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620260|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620261|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620262|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620263|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620264|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620265|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620266|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620267|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620268|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620269|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620270|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620271|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620272|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620273|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620274|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620275|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620276|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620385|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620909|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620277|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620278|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620279|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620280|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620281|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620282|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620283|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620284|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620285|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620286|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620287|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620288|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620289|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620290|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620291|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620292|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620293|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620294|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620295|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620296|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620297|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620386|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
638325|NCT00428597|O2|Outcome|Placebo|Matching placebo.
620298|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620299|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620300|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620301|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620302|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620303|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620304|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620305|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620306|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620307|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620308|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620309|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620310|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620311|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620312|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620313|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620314|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620315|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620316|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620317|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620318|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620387|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620319|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620320|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620321|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620322|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620323|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620324|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620325|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620326|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620327|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620328|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620329|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620330|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620331|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620332|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620333|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620334|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620335|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620336|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620337|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620338|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620339|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620388|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
638640|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
620340|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620341|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620342|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620343|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620344|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620345|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620346|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620347|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620348|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620349|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620350|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620351|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620352|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620353|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620354|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620355|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620356|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620357|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620358|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620359|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620360|NCT00471237|O7|Outcome|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620389|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
638641|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
620361|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620362|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620363|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620364|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620365|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620366|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620367|NCT00471237|O6|Outcome|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620368|NCT00471237|O5|Outcome|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620369|NCT00471237|O4|Outcome|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620370|NCT00471237|O3|Outcome|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620371|NCT00471237|O2|Outcome|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620372|NCT00471237|O1|Outcome|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620373|NCT00471237|E7|Reported Event|Teriparatide, 20 mcg, SC Injection, OD|Participants received Teriparatide, 20 mcg, SC injection, OD for 12 months. Participants were supplied with elemental calcium 500-660mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620374|NCT00471237|E6|Reported Event|Alendronate, 70 mg, Capsule, OW|Participants received Alendronate, 70 mg, capsule, OW and matching placebo OD (matching to ronacaleret tablet) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620375|NCT00471237|E5|Reported Event|Ronacaleret, 400 mg Tablet, OD|Participants received Ronacaleret, 400 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620376|NCT00471237|E4|Reported Event|Ronacaleret, 300 mg Tablet, OD|Participants received ronacaleret, 300 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620377|NCT00471237|E3|Reported Event|Ronacaleret, 200 mg Tablet, OD|Participants received ronacaleret, 200 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620378|NCT00471237|E2|Reported Event|Ronacaleret, 100 mg Tablet, OD|Participants received ronacaleret, 100 mg tablet, OD and matching placebo, OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620379|NCT00471237|E1|Reported Event|Placebo|Participants received matching placebo OD (matching to ronacaleret tablet) and matching placebo OW (matching to Alendronate capsule) for 12 months. Participants were supplied with elemental calcium 500-660 mg and vitamin D, at least 400 IU, OD in the evening as dietary supplements throughout the study.
620380|NCT00471146|B3|Baseline|Total|Total of all reporting groups
620381|NCT00471146|B2|Baseline|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620382|NCT00471146|B1|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620383|NCT00471146|P2|Participant Flow|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
638642|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
620391|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620392|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620393|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620394|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620395|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620396|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620397|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620398|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620399|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620400|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620401|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620402|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620403|NCT00471146|E2|Reported Event|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620404|NCT00471146|E1|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
620405|NCT00471107|B4|Baseline|Total|Total of all reporting groups
620406|NCT00471107|B3|Baseline|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
620407|NCT00471107|B2|Baseline|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620408|NCT00471107|B1|Baseline|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620409|NCT00471107|P3|Participant Flow|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
620410|NCT00471107|P2|Participant Flow|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620411|NCT00471107|P1|Participant Flow|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620412|NCT00471107|O3|Outcome|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
620413|NCT00471107|O2|Outcome|Left Prefrontal Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620414|NCT00471107|O1|Outcome|Left Prefrontal Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620415|NCT00471107|E3|Reported Event|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
620416|NCT00471107|E2|Reported Event|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620417|NCT00471107|E1|Reported Event|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
620418|NCT00471068|B3|Baseline|Total|Total of all reporting groups
620419|NCT00471068|B2|Baseline|Cosopt|
620420|NCT00471068|B1|Baseline|Travatan|
620421|NCT00471068|P2|Participant Flow|Cosopt|
620422|NCT00471068|P1|Participant Flow|Travatan|
620423|NCT00471068|O2|Outcome|Cosopt|
620424|NCT00471068|O1|Outcome|Travatan|
620425|NCT00471068|E2|Reported Event|Cosopt|
620426|NCT00471068|E1|Reported Event|Travatan|
620427|NCT00470847|B1|Baseline|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
620428|NCT00470847|P1|Participant Flow|Lapatinib,Whole Brain Radiation,Herceptin|Participants received lapatinib, orally, 750mg twice on day one followed by 1000mg, 1250mg, or 1500mg once daily. Whole Brain Radiation therapy (WBRT) (37.5 Gy, 15 fractions) began 1-8 days after starting lapatinib. Lapatinib was continued through WBRT. Following WBRT, patients received trastuzumab intravenously 2mg/kg weekly and lapatinib 1000mg orally once daily.
620429|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
620432|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
620433|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
620434|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
620435|NCT00470847|E3|Reported Event|Dose Level 3|n=5 participants 1500 mg lapatinib daily
620436|NCT00470847|E2|Reported Event|Dose Level 1|n=3 participants 1000 mg lapatinib daily
620437|NCT00470847|E1|Reported Event|Dose Level 2|n=27 participants Maximum Tolerated Dose 1250 mg lapatinib daily
620438|NCT00470834|B3|Baseline|Total|Total of all reporting groups
620439|NCT00470834|B2|Baseline|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620440|NCT00470834|B1|Baseline|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620441|NCT00470834|P2|Participant Flow|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620442|NCT00470834|P1|Participant Flow|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620443|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620444|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620445|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620446|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620447|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620448|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620449|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620485|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
638643|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
620450|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620451|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620452|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620453|NCT00470834|E2|Reported Event|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620454|NCT00470834|E1|Reported Event|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
620455|NCT00470626|B1|Baseline|Celect Vena Cava Filter|
620456|NCT00470626|P1|Participant Flow|Celect Vena Cava Filter|
620457|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
620458|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
620459|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
620460|NCT00470626|E1|Reported Event|Celect Vena Cava Filter|
620461|NCT00470600|B3|Baseline|Total|Total of all reporting groups
620462|NCT00470600|B2|Baseline|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
620463|NCT00470600|B1|Baseline|Placebo|250 mL of normal saline.
620464|NCT00470600|P2|Participant Flow|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
620465|NCT00470600|P1|Participant Flow|Placebo|250 mL of normal saline.
620466|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
620467|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
620468|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
620469|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
620470|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
620471|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
620472|NCT00470600|E2|Reported Event|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
620473|NCT00470600|E1|Reported Event|Placebo|250 mL of normal saline.
620474|NCT00470548|B3|Baseline|Total|Total of all reporting groups
620475|NCT00470548|B2|Baseline|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
620476|NCT00470548|B1|Baseline|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620477|NCT00470548|P4|Participant Flow|Phase II|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
620478|NCT00470548|P3|Participant Flow|Phase I: Dose Level 3|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
620479|NCT00470548|P2|Participant Flow|Phase I: Dose Level 2|Pemetrexed 500 mg/m2 plus Abraxane 220 mg/m2
620480|NCT00470548|P1|Participant Flow|Phase I: Dose Level 1|Pemetrexed 500 mg/m2 plus Abraxane 180 mg/m2
620481|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
620482|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620483|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
620484|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620520|NCT00470418|E2|Reported Event|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
620486|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620487|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
620488|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620489|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
620490|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620491|NCT00470548|O1|Outcome|Phase II: Pemetrexed and Abraxane|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
620492|NCT00470548|O3|Outcome|Phase I: Dose Level 3|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620493|NCT00470548|O2|Outcome|Phase I: Dose Level 2|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 220 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620494|NCT00470548|O1|Outcome|Phase I: Dose Level 1|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
620495|NCT00470548|E2|Reported Event|Phase II: Abraxane and Alimta|"Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days.~Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)~Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
620496|NCT00470548|E1|Reported Event|Phase I: Abraxane and Alimta|"Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days.~Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)~Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
620497|NCT00470535|B1|Baseline|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620498|NCT00470535|P1|Participant Flow|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620499|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620500|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620501|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620502|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620503|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620504|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620505|NCT00470535|E1|Reported Event|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
620506|NCT00470470|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
620507|NCT00470470|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
620508|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
620509|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
620510|NCT00470470|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
620511|NCT00470418|B3|Baseline|Total|Total of all reporting groups
620512|NCT00470418|B2|Baseline|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
620513|NCT00470418|B1|Baseline|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
620514|NCT00470418|P2|Participant Flow|Placebo|"Placebo: placebo comparator identical in pill size, appearance and number~Subjects with Alzheimer's Disease"
620515|NCT00470418|P1|Participant Flow|NIC5-15|"NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study.~Subjects with Alzheimer's Disease"
620516|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
620517|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
620518|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
620519|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
620521|NCT00470418|E1|Reported Event|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
620522|NCT00470392|B3|Baseline|Total|Total of all reporting groups
620523|NCT00470392|B2|Baseline|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620524|NCT00470392|B1|Baseline|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620525|NCT00470392|P2|Participant Flow|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620526|NCT00470392|P1|Participant Flow|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620527|NCT00470392|O2|Outcome|Clobetasol|"Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.~No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated."
620528|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620529|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
620530|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620531|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
620532|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620533|NCT00470392|E2|Reported Event|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620534|NCT00470392|E1|Reported Event|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
620535|NCT00470366|B1|Baseline|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
620585|NCT00470158|E4|Reported Event|Zinc Alone|zinc, alternating daily with placebo
620536|NCT00470366|P1|Participant Flow|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
620537|NCT00470366|O1|Outcome|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
620538|NCT00470366|O1|Outcome|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
620539|NCT00470366|O1|Outcome|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
620540|NCT00470366|O1|Outcome|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
620541|NCT00470366|E1|Reported Event|Paclitaxel, Ifosfamide, and Cisplatin|"-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.~pegfilgrastim~cisplatin~ifosfamide~paclitaxel"
620542|NCT00470301|B1|Baseline|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
620543|NCT00470301|P1|Participant Flow|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
620544|NCT00470301|O1|Outcome|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
620545|NCT00470301|E1|Reported Event|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
620546|NCT00470275|B1|Baseline|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
620547|NCT00470275|P1|Participant Flow|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
620548|NCT00470275|O1|Outcome|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
620549|NCT00470275|E1|Reported Event|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
620550|NCT00470262|B3|Baseline|Total|Total of all reporting groups
620551|NCT00470262|B2|Baseline|Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD|Treatment with Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD in subjects with pre diabetes
620552|NCT00470262|B1|Baseline|Fenofibrate 145 mg PO QD|Treatment fenofibrate 145 mg PO QD in subjects with pre diabetes
620553|NCT00470262|P2|Participant Flow|Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD|Pioglitazone and Fenofibrate: Subjects will be randomized to a combination of both fenofibrate(145mg PO QD) and pioglitazone 45 mg PO QD
620554|NCT00470262|P1|Participant Flow|Fenofibrate|Treatment with fenofibrate 145mg PO QD
620555|NCT00470262|O2|Outcome|Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID|Treatment with pioglitazone and fenofibrate in subjects with pre diabetes
620556|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
620557|NCT00470262|O2|Outcome|Fenofibrate 145 mg PO QD + Pioglitazone|Treatment with fenofibrate and pioglitazone in subjects with pre diabetes
620558|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
620559|NCT00470262|E2|Reported Event|Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD|Treatment with fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD in subjects with pre diabetes
620560|NCT00470262|E1|Reported Event|Fenofibrate 145mg PO QD|Treatment with fenofibrate 145 mg PO QD in subjects with pre diabetes
620561|NCT00470184|B1|Baseline|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
620586|NCT00470158|E3|Reported Event|Iron Alone|iron, alternating daily with placebo
620587|NCT00470158|E2|Reported Event|Separate Iron and Zinc|iron, alternating daily with zinc
620588|NCT00470158|E1|Reported Event|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
620562|NCT00470184|P1|Participant Flow|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
620563|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
620564|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
620565|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
620566|NCT00470184|O1|Outcome|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
620567|NCT00470184|E1|Reported Event|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
620568|NCT00470158|B6|Baseline|Total|Total of all reporting groups
620569|NCT00470158|B5|Baseline|Placebo|placebo daily
620570|NCT00470158|B4|Baseline|Zinc Alone|zinc, alternating daily with placebo
620571|NCT00470158|B3|Baseline|Iron Alone|iron, alternating daily with placebo
620572|NCT00470158|B2|Baseline|Separate Iron and Zinc|iron, alternating daily with zinc
620573|NCT00470158|B1|Baseline|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
620574|NCT00470158|P5|Participant Flow|Placebo|placebo daily
620575|NCT00470158|P4|Participant Flow|Zinc Alone|zinc, alternating daily with placebo
620576|NCT00470158|P3|Participant Flow|Iron Alone|iron, alternating daily with placebo
620577|NCT00470158|P2|Participant Flow|Separate Iron and Zinc|iron, alternating daily with zinc
620578|NCT00470158|P1|Participant Flow|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
620579|NCT00470158|O5|Outcome|Placebo|placebo daily
620580|NCT00470158|O4|Outcome|Zinc Alone|zinc, alternating daily with placebo
620581|NCT00470158|O3|Outcome|Iron Alone|iron, alternating daily with placebo
620582|NCT00470158|O2|Outcome|Separate Iron and Zinc|iron, alternating daily with zinc
620583|NCT00470158|O1|Outcome|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
620584|NCT00470158|E5|Reported Event|Placebo|placebo daily
620590|NCT00470106|B4|Baseline|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
620591|NCT00470106|B3|Baseline|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
620592|NCT00470106|B2|Baseline|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
620593|NCT00470106|B1|Baseline|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
620594|NCT00470106|P4|Participant Flow|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
620595|NCT00470106|P3|Participant Flow|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
620596|NCT00470106|P2|Participant Flow|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
620597|NCT00470106|P1|Participant Flow|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
620598|NCT00470106|O4|Outcome|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
620599|NCT00470106|O3|Outcome|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
620600|NCT00470106|O2|Outcome|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
620601|NCT00470106|O1|Outcome|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
620602|NCT00470106|O4|Outcome|Skills Training|"control training~skills training: Skills training in how to identify symptoms of illness and medication side effects."
620603|NCT00470106|O3|Outcome|Hybrid Intervention|"combined social cognitive and cognitive remediation training~hybrid intervention: A combination of the two groups listed above."
620604|NCT00470106|O2|Outcome|Cognitive Remediation|"cognitive remediation~Cognitive remediation: Computer exercises in attention, memory, and speed of processing."
620605|NCT00470106|O1|Outcome|Social Cognitive Skills Training|"social cognitive skills training~Social Cognitive skills training: Group training on emotion perception, social perception, and understanding others' mental states."
620606|NCT00470106|E4|Reported Event|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
620607|NCT00470106|E3|Reported Event|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
620608|NCT00470106|E2|Reported Event|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
620609|NCT00470106|E1|Reported Event|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
620610|NCT00470067|B1|Baseline|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
620611|NCT00470067|P1|Participant Flow|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
620612|NCT00470067|O1|Outcome|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
620613|NCT00470067|E1|Reported Event|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
620614|NCT00470054|B1|Baseline|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620615|NCT00470054|P1|Participant Flow|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620616|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620617|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620618|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620619|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620620|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620621|NCT00470054|E1|Reported Event|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
620622|NCT00469898|B1|Baseline|Therapeutic Intervention|
620623|NCT00469898|P1|Participant Flow|Therapeutic Intervention|
620624|NCT00469898|O1|Outcome|Therapeutic Intervention|
620625|NCT00469898|O1|Outcome|Therapeutic Intervention|
620626|NCT00469898|O1|Outcome|Therapeutic Intervention|
620627|NCT00469898|O1|Outcome|Therapeutic Intervention|
620628|NCT00469898|E1|Reported Event|Therapeutic Intervention|
620629|NCT00469859|B3|Baseline|Total|Total of all reporting groups
620630|NCT00469859|B2|Baseline|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620684|NCT00469391|E1|Reported Event|GI Sleeve|N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices).
620685|NCT00469274|B3|Baseline|Total|Total of all reporting groups
638644|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
620631|NCT00469859|B1|Baseline|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620632|NCT00469859|P2|Participant Flow|Group 2 (Lestaurtinib: Dose 62.5 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)~cytarabine"
620633|NCT00469859|P1|Participant Flow|Group 1 (Lestaurtinib Dose 50 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620634|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620635|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620636|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620637|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620686|NCT00469274|B2|Baseline|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620687|NCT00469274|B1|Baseline|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620638|NCT00469859|E2|Reported Event|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620639|NCT00469859|E1|Reported Event|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
620640|NCT00469833|B1|Baseline|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
620641|NCT00469833|P1|Participant Flow|Uncontrolled Type 2 Diabetic Subjects|Eligible subjects will have measures of insulin secretion measured using the OGTT/hyperglycemic clamp technique before and after 2 months of treatment to lower blood glucose.
620642|NCT00469833|O1|Outcome|Uncontrolled Type 2 Diabetic Subjects|
620643|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled Type 2 diabetic subjects.
620644|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects.
620645|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects
620646|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects
620647|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects.
620648|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled type 2 diabetic subjects.
620649|NCT00469833|E1|Reported Event|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
620650|NCT00469508|B3|Baseline|Total|Total of all reporting groups
620651|NCT00469508|B2|Baseline|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
620652|NCT00469508|B1|Baseline|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
620653|NCT00469508|P2|Participant Flow|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
620654|NCT00469508|P1|Participant Flow|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
620655|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
620656|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
620657|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
620658|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
620659|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
620660|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
620661|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
620662|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
620663|NCT00469508|E2|Reported Event|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
620664|NCT00469508|E1|Reported Event|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
620665|NCT00469456|B3|Baseline|Total|Total of all reporting groups
620666|NCT00469456|B2|Baseline|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
620667|NCT00469456|B1|Baseline|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
620668|NCT00469456|P2|Participant Flow|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
620669|NCT00469456|P1|Participant Flow|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
620670|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
620671|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
620672|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
620673|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
620674|NCT00469456|E2|Reported Event|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
620675|NCT00469456|E1|Reported Event|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
620676|NCT00469391|B3|Baseline|Total|Total of all reporting groups
620677|NCT00469391|B2|Baseline|Sham Control|Sham Procedure: Weight loss
620678|NCT00469391|B1|Baseline|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
620679|NCT00469391|P2|Participant Flow|Sham Control|Sham Procedure followed by standard-of-care diet therapy
620680|NCT00469391|P1|Participant Flow|GI Sleeve|GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy
620681|NCT00469391|O2|Outcome|Sham Control|Sham Procedure: Weight loss
620682|NCT00469391|O1|Outcome|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
620688|NCT00469274|P2|Participant Flow|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620689|NCT00469274|P1|Participant Flow|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620690|NCT00469274|O2|Outcome|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620691|NCT00469274|O1|Outcome|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620692|NCT00469274|E2|Reported Event|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620693|NCT00469274|E1|Reported Event|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
620694|NCT00469209|B4|Baseline|Total|Total of all reporting groups
620695|NCT00469209|B3|Baseline|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620696|NCT00469209|B2|Baseline|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620697|NCT00469209|B1|Baseline|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620698|NCT00469209|P3|Participant Flow|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620699|NCT00469209|P2|Participant Flow|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620700|NCT00469209|P1|Participant Flow|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620701|NCT00469209|O3|Outcome|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620702|NCT00469209|O2|Outcome|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620703|NCT00469209|O1|Outcome|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620704|NCT00469209|E3|Reported Event|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620705|NCT00469209|E2|Reported Event|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620706|NCT00469209|E1|Reported Event|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
620707|NCT00469092|B3|Baseline|Total|Total of all reporting groups
620708|NCT00469092|B2|Baseline|Glargine|Insulin glargine + metformin + glimepiride
620709|NCT00469092|B1|Baseline|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620710|NCT00469092|P2|Participant Flow|Glargine|Insulin glargine + metformin + glimepiride
620711|NCT00469092|P1|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620712|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
620713|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620714|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
620715|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620716|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
620717|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620718|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
620719|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620720|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
620721|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620722|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
620723|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620724|NCT00469092|E2|Reported Event|Glargine|Insulin glargine + metformin + glimepiride
620725|NCT00469092|E1|Reported Event|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
620726|NCT00469079|B4|Baseline|Total|Total of all reporting groups
620727|NCT00469079|B3|Baseline|Assigned to Camel Snus|Camel Snus - oral tobacco product
620728|NCT00469079|B2|Baseline|Assigned to Taboka|Taboka - oral tobacco product
620729|NCT00469079|B1|Baseline|Assigned to NRT|Nicotine gum or nicotine lozenge
620730|NCT00469079|P3|Participant Flow|Assigned to Camel Snus|Camel Snus - oral tobacco product
620731|NCT00469079|P2|Participant Flow|Assigned to Taboka|Taboka - oral tobacco product
620732|NCT00469079|P1|Participant Flow|Assigned to NRT|Nicotine gum or nicotine lozenge
620733|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
620734|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
620735|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
620742|NCT00469079|O3|Outcome|Snus|Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
620743|NCT00469079|O2|Outcome|Taboka|Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
620744|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or nicotine lozenge
620745|NCT00469079|E3|Reported Event|Assigned to Camel Snus|Camel Snus - oral tobacco product
620746|NCT00469079|E2|Reported Event|Assigned to Taboka|Taboka - oral tobacco product
620747|NCT00469079|E1|Reported Event|Assigned to NRT|Nicotine gum or nicotine lozenge
620748|NCT00468910|B3|Baseline|Total|Total of all reporting groups
620749|NCT00468910|B2|Baseline|Placebo|Patients receive oral placebo once daily.
620750|NCT00468910|B1|Baseline|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
620751|NCT00468910|P2|Participant Flow|Placebo|Patients receive oral placebo once daily.
620752|NCT00468910|P1|Participant Flow|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
620753|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
620754|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
620755|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
620756|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
620757|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
620758|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
620759|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
620760|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
620761|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
620762|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) 325 mg once daily.
620763|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
620764|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) 325 mg once daily.
620765|NCT00468910|E2|Reported Event|Placebo|"Patients receive oral placebo once daily.~placebo: Given orally~laboratory biomarker analysis: Correlative study"
620766|NCT00468910|E1|Reported Event|Acetylsalicylic Acid|"Patients receive oral acetylsalicylic acid (aspirin) once daily.~acetylsalicylic acid: Given orally~laboratory biomarker analysis: Correlative study"
620767|NCT00468858|B4|Baseline|Total|Total of all reporting groups
620768|NCT00468858|B3|Baseline|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620769|NCT00468858|B2|Baseline|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620770|NCT00468858|B1|Baseline|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620771|NCT00468858|P3|Participant Flow|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620772|NCT00468858|P2|Participant Flow|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620773|NCT00468858|P1|Participant Flow|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620774|NCT00468858|O36|Outcome|DEN-4, Placebo, Total|Antibody DEN-4, Placebo group, Pre-vaccination status = Total
620775|NCT00468858|O35|Outcome|DEN-4, Placebo, S+|Antibody DEN-4, Placebo group, Pre-vaccination status = S+
620776|NCT00468858|O34|Outcome|DEN-4, Placebo, S-|Antibody DEN-4, Placebo group, Pre-vaccination status = S-
620777|NCT00468858|O33|Outcome|DEN-4, F19, Total|Antibody DEN-4, Group F19, Pre-vaccination status = Total
620778|NCT00468858|O32|Outcome|DEN-4, F19, S+|Antibody DEN-4, Group F19, Pre-vaccination status = S+
620779|NCT00468858|O31|Outcome|DEN-4, F19, S-|Antibody DEN-4, Group F19, Pre-vaccination status = S-
620780|NCT00468858|O30|Outcome|DEN-4, F17, Total|Antibody DEN-4, Group F17, Pre-vaccination status = Total
620781|NCT00468858|O29|Outcome|DEN-4, F17, S+|Antibody DEN-4, Group F17, Pre-vaccination status = S+
620782|NCT00468858|O28|Outcome|DEN-4, F17, S-|Antibody DEN-4, Group F17, Pre-vaccination status = S-
620783|NCT00468858|O27|Outcome|DEN-3, Placebo, Total|Antibody DEN-3, Placebo group, Pre-vaccination status = Total
620784|NCT00468858|O26|Outcome|DEN-3, Placebo, S+|Antibody DEN-3, Placebo group, Pre-vaccination status = S+
620785|NCT00468858|O25|Outcome|DEN-3, Placebo, S-|Antibody DEN-3, Placebo group, Pre-vaccination status = S-
620786|NCT00468858|O24|Outcome|DEN-3, F19, Total|Antibody DEN-3, Group F19, Pre-vaccination status = Total
620787|NCT00468858|O23|Outcome|DEN-3, F19, S+|Antibody DEN-3, Group F19, Pre-vaccination status = S+
620788|NCT00468858|O22|Outcome|DEN-3, F19, S-|Antibody DEN-3, Group F19, Pre-vaccination status = S-
620789|NCT00468858|O21|Outcome|DEN-3, F17, Total|Antibody DEN-3, Group F17, Pre-vaccination status = Total
620790|NCT00468858|O20|Outcome|DEN-3, F17, S+|Antibody DEN-3, Group F17, Pre-vaccination status = S+
620791|NCT00468858|O19|Outcome|DEN-3, F17, S-|Antibody DEN-3, Group F17, Pre-vaccination status = S-
620792|NCT00468858|O18|Outcome|DEN-2, Placebo, Total|Antibody DEN-2, Placebo group, Pre-vaccination status = Total
620793|NCT00468858|O17|Outcome|DEN-2, Placebo, S+|Antibody DEN-2, Placebo group, Pre-vaccination status = S+
620794|NCT00468858|O16|Outcome|DEN-2, Placebo, S-|Antibody DEN-2, Placebo group, Pre-vaccination status = S-
620795|NCT00468858|O15|Outcome|DEN-2, F19, Total|Antibody DEN-2, Group F19, Pre-vaccination status = Total
620798|NCT00468858|O12|Outcome|DEN-2, F17, Total|Antibody DEN-2,. Group F17, Pre-vaccination status = Total
620799|NCT00468858|O11|Outcome|DEN-2, F17, S+|Antibody DEN-2, Group F17, Pre-vaccination status = S+
620800|NCT00468858|O10|Outcome|DEN-2, F17, S-|Antibody DEN-2, Group F17, Pre-vaccination status = S-
620801|NCT00468858|O9|Outcome|DEN-1, Placebo, Total|Antibody DEN-1, Placebo group, Pre-vaccination status = Total
620802|NCT00468858|O8|Outcome|DEN-1, Placebo, S+|Antibody DEN-1, Placebo group, Pre-vaccination status = S+
620803|NCT00468858|O7|Outcome|DEN-1, Placebo, S-|Antibody DEN-1, Placebo group, Pre-vaccination status = S-
620804|NCT00468858|O6|Outcome|DEN-1, F19, Total|Antibody DEN-1, Group F19, Pre-vaccination status = Total
620805|NCT00468858|O5|Outcome|DEN-1, F19, S+|Antibody DEN-1, Group F19, Pre-vaccination group = S+
620806|NCT00468858|O4|Outcome|DEN-1, F19, S-|Antibody DEN-1, Group F19, Pre-vaccination status = S-
620807|NCT00468858|O3|Outcome|DEN-1, F17, Total|Antibody DEN-1, Group F17, Pre-vaccination status = Total
620808|NCT00468858|O2|Outcome|DEN-1, F17, S+|Antibody DEN-1, Group F17, Pre-vaccination status = S+
620809|NCT00468858|O1|Outcome|DEN-1, F17, S-|Antibody DEN-1, Group F17, Pre-vaccination status = S-
620810|NCT00468858|O36|Outcome|DEN-4, Placebo, Total|Antibody DEN-4, Placebo group, Pre-vaccination status = Total
620811|NCT00468858|O35|Outcome|DEN-4, Placebo, S+|Antibody DEN-4, Placebo group, Pre-vaccination status = S+
620812|NCT00468858|O34|Outcome|DEN-4, Placebo, S-|Antibody DEN-4, Placebo group, Pre-vaccination status = S-
620813|NCT00468858|O33|Outcome|DEN-4, F19, Total|Antibody DEN-4, Group F19, Pre-vaccination status = Total
620814|NCT00468858|O32|Outcome|DEN-4, F19, S+|Antibody DEN-4, Group F19, Pre-vaccination status = S+
620815|NCT00468858|O31|Outcome|DEN-4, F19, S-|Antibody DEN-4, Group F19, Pre-vaccination status = S-
620816|NCT00468858|O30|Outcome|DEN-4, F17, Total|Antibody DEN-4, Group F17, Pre-vaccination status = Total
620817|NCT00468858|O29|Outcome|DEN-4, F17, S+|Antibody DEN-4, Group F17, Pre-vaccination status = S+
620818|NCT00468858|O28|Outcome|DEN-4, F17, S-|Antibody DEN-4, Group F17, Pre-vaccination status = S-
620819|NCT00468858|O27|Outcome|DEN-3, Placebo, Total|Antibody DEN-3, Placebo group, Pre-vaccination status = Total
620820|NCT00468858|O26|Outcome|DEN-3, Placebo, S+|Antibody DEN-3, Placebo group, Pre-vaccination status = S+
620821|NCT00468858|O25|Outcome|DEN-3, Placebo, S-|Antibody DEN-3, Placebo group, Pre-vaccination status = S-
620822|NCT00468858|O24|Outcome|DEN-3, F19, Total|Antibody DEN-3, Group F19, Pre-vaccination status = Total
620823|NCT00468858|O23|Outcome|DEN-3, F19, S+|Antibody DEN-3, Group F19, Pre-vaccination status = S+
620824|NCT00468858|O22|Outcome|DEN-3, F19, S-|Antibody DEN-3, Group F19, Pre-vaccination status = S-
620825|NCT00468858|O21|Outcome|DEN-3, F17, Total|Antibody DEN-3, Group F17, Pre-vaccination status = Total
620826|NCT00468858|O20|Outcome|DEN-3, F17, S+|Antibody DEN-3, Group F17, Pre-vaccination status = S+
620827|NCT00468858|O19|Outcome|DEN-3, F17, S-|Antibody DEN-3, Group F17, Pre-vaccination status = S-
620828|NCT00468858|O18|Outcome|DEN-2, Placebo, Total|Antibody DEN-2, Placebo group, Pre-vaccination status = Total
620829|NCT00468858|O17|Outcome|DEN-2, Placebo, S+|Antibody DEN-2, Placebo group, Pre-vaccination status = S+
620830|NCT00468858|O16|Outcome|DEN-2, Placebo, S-|Antibody DEN-2, Placebo group, Pre-vaccination status = S-
620831|NCT00468858|O15|Outcome|DEN-2, F19, Total|Antibody DEN-2, Group F19, Pre-vaccination status = Total
620832|NCT00468858|O14|Outcome|DEN-2, F19, S+|Antibody DEN-2, Group F19, Pre-vaccination status = S+
620833|NCT00468858|O13|Outcome|DEN-2, F19, S-|Antibody DEN-2, Group F19, Pre-vaccination status = S-
620834|NCT00468858|O12|Outcome|DEN-2, F17, Total|Antibody DEN-2,. Group F17, Pre-vaccination status = Total
620835|NCT00468858|O11|Outcome|DEN-2, F17, S+|Antibody DEN-2, Group F17, Pre-vaccination status = S+
620836|NCT00468858|O10|Outcome|DEN-2, F17, S-|Antibody DEN-2, Group F17, Pre-vaccination status = S-
620837|NCT00468858|O9|Outcome|DEN-1, Placebo, Total|Antibody DEN-1, Placebo group, Pre-vaccination status = Total
620838|NCT00468858|O8|Outcome|DEN-1, Placebo, S+|Antibody DEN-1, Placebo group, Pre-vaccination status = S+
620839|NCT00468858|O7|Outcome|DEN-1, Placebo, S-|Antibody DEN-1, Placebo group, Pre-vaccination status = S-
620840|NCT00468858|O6|Outcome|DEN-1, F19, Total|Antibody DEN-1, Group F19, Pre-vaccination status = Total
620841|NCT00468858|O5|Outcome|DEN-1, F19, S+|Antibody DEN-1, Group F19, Pre-vaccination group = S+
620842|NCT00468858|O4|Outcome|DEN-1, F19, S-|Antibody DEN-1, Group F19, Pre-vaccination status = S-
620843|NCT00468858|O3|Outcome|DEN-1, F17, Total|Antibody DEN-1, Group F17, Pre-vaccination status = Total
620844|NCT00468858|O2|Outcome|DEN-1, F17, S+|Antibody DEN-1, Group F17, Pre-vaccination status = S+
620845|NCT00468858|O1|Outcome|DEN-1, F17, S-|Antibody DEN-1, Group F17, Pre-vaccination status = S-
620846|NCT00468858|O12|Outcome|Placebo: PII (M7)|Placebo control Post-dose 2, month 7
620847|NCT00468858|O11|Outcome|Placebo: PI (M6)|Placebo control Post-dose 1, month 6
620848|NCT00468858|O10|Outcome|Placebo: PI (M3)|Placebo control Post-dose 1, month 3
620849|NCT00468858|O9|Outcome|Placebo: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
620850|NCT00468858|O8|Outcome|F19 PII (M7)|Post-Transfection F-19 Post-dose 2, month 7
620851|NCT00468858|O7|Outcome|F19 PI (M6)|Post-Transfection F-19 Post-dose 1, month 6
620852|NCT00468858|O6|Outcome|F19 PI (M3)|Post-Transfection F-19 Post-dose 1, month 3
620853|NCT00468858|O5|Outcome|F19: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
620854|NCT00468858|O4|Outcome|F17 PII (M7)|Post-Transfection F-17 Post-dose 2, month 7
620855|NCT00468858|O3|Outcome|F17 PI (M6)|Post-Transfection F-17 Post-dose 1, month 6
620856|NCT00468858|O2|Outcome|F17 PI (M3)|Post-Transfection F-17 Post-dose 1, month 3
620857|NCT00468858|O1|Outcome|F17: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
620858|NCT00468858|O12|Outcome|Placebo: PII (M7)|Placebo control Post-dose 2, month 7
620859|NCT00468858|O11|Outcome|Placebo: PI (M6)|Placebo control Post-dose 1, month 6
620860|NCT00468858|O10|Outcome|Placebo: PI (M3)|Placebo control Post-dose 1, month 3
620861|NCT00468858|O9|Outcome|Placebo: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
620862|NCT00468858|O8|Outcome|F19 PII (M7)|Post-Transfection F-19 Post-dose 2, month 7
620863|NCT00468858|O7|Outcome|F19 PI (M6)|Post-Transfection F-19 Post-dose 1, month 6
620864|NCT00468858|O6|Outcome|F19 PI (M3)|Post-Transfection F-19 Post-dose 1, month 3
620865|NCT00468858|O5|Outcome|F19: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
620866|NCT00468858|O4|Outcome|F17 PII (M7)|Post-Transfection F-17 Post-dose 2, month 7
620867|NCT00468858|O3|Outcome|F17 PI (M6)|Post-Transfection F-17 Post-dose 1, month 6
620868|NCT00468858|O2|Outcome|F17 PI (M3)|Post-Transfection F-17 Post-dose 1, month 3
620869|NCT00468858|O1|Outcome|F17: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
620870|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620871|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620872|NCT00468858|O6|Outcome|After 31-Day Post-Vaccination Period: Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620873|NCT00468858|O5|Outcome|After 31-Day Post Vaccination Period: F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620874|NCT00468858|O4|Outcome|After 31-Day Post Vaccination Period: F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620875|NCT00468858|O3|Outcome|During 31-Day Post Vaccination: Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620876|NCT00468858|O2|Outcome|During 31-Day Post Vaccination: F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620877|NCT00468858|O1|Outcome|During 31-Day Post Vaccination: F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620878|NCT00468858|O3|Outcome|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620879|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620880|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620881|NCT00468858|O3|Outcome|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620882|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620883|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620884|NCT00468858|O3|Outcome|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620885|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620886|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620887|NCT00468858|E3|Reported Event|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
620888|NCT00468858|E2|Reported Event|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620889|NCT00468858|E1|Reported Event|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
620890|NCT00468845|B4|Baseline|Total|Total of all reporting groups
620891|NCT00468845|B3|Baseline|Placebo|Matching placebo capsule
620892|NCT00468845|B2|Baseline|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620893|NCT00468845|B1|Baseline|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620894|NCT00468845|P3|Participant Flow|Placebo|Matching placebo capsule
620895|NCT00468845|P2|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620896|NCT00468845|P1|Participant Flow|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620897|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620898|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620899|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620900|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620901|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620902|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620903|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620904|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620905|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620906|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620907|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620908|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620910|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620911|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620912|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620913|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620914|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620915|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620916|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620917|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620918|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620919|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620920|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620921|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620922|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620923|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620924|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620925|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620926|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620927|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620928|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620929|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620930|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620931|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620932|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620933|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620934|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620935|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620936|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620937|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620938|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620939|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620940|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620941|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620942|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620943|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620944|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620945|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620946|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620947|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620948|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620949|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620950|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620951|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620952|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620953|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620954|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620955|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620956|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620957|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620958|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620959|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620960|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620961|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620962|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620963|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620964|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620965|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620966|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620967|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620968|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620969|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620970|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620971|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620972|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620973|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620974|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620975|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620976|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620977|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620978|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620979|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620980|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620981|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620982|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620983|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620984|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620985|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620986|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620987|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620988|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620989|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620990|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620991|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620992|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620993|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620994|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620995|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620996|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
620997|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
620998|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
620999|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621000|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621001|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621002|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621003|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621004|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621005|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621006|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621007|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621008|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621009|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621010|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621011|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621012|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621013|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621014|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621015|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621016|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621017|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621018|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621019|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621020|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621021|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621022|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621023|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
621024|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621025|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621026|NCT00468845|E3|Reported Event|Placebo|Matching placebo capsule
621027|NCT00468845|E2|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
621028|NCT00468845|E1|Reported Event|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
621029|NCT00468819|B4|Baseline|Total|Total of all reporting groups
621030|NCT00468819|B3|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621031|NCT00468819|B2|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621032|NCT00468819|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621033|NCT00468819|P3|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621034|NCT00468819|P2|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621035|NCT00468819|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621036|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621037|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621038|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621039|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621040|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621373|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
621041|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621042|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621043|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621044|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621045|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621046|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621047|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621048|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621049|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621050|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621051|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621052|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621053|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621054|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621055|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621056|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621057|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621058|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621059|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621060|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621061|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621062|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621063|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621064|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621065|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621066|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621067|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621068|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621069|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621070|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621071|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621072|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621073|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621074|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621075|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621874|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621076|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621077|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621078|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621079|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621080|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621081|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621082|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621083|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621084|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621085|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621086|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621087|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621088|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621089|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621090|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621091|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621092|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621093|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621094|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621095|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621096|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621097|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621098|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621099|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621100|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621101|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621102|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621103|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621104|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621105|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621106|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621107|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621108|NCT00468819|E4|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621109|NCT00468819|E3|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621110|NCT00468819|E2|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621875|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621111|NCT00468819|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
621112|NCT00468728|B3|Baseline|Total|Total of all reporting groups
621113|NCT00468728|B2|Baseline|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
621114|NCT00468728|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
621115|NCT00468728|P2|Participant Flow|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
621116|NCT00468728|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
621117|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
621118|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
621119|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily
621120|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily
621121|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
621122|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
621123|NCT00468728|E2|Reported Event|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
621124|NCT00468728|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
621125|NCT00468676|B3|Baseline|Total|Total of all reporting groups
621126|NCT00468676|B2|Baseline|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621127|NCT00468676|B1|Baseline|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621128|NCT00468676|P2|Participant Flow|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621129|NCT00468676|P1|Participant Flow|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621130|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621131|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621132|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621133|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621134|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621135|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621136|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621137|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621138|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621139|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621140|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
621141|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
621142|NCT00468676|O1|Outcome|Effect Size of Invervention Group to Standard Care|This was an intent to treat analysis calculating the intervention effect size of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes combined
621143|NCT00468676|E2|Reported Event|Care Management Intervention|"Care management intervention~Nurse-led case management: The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress."
621144|NCT00468676|E1|Reported Event|Usual Care|"Treatment as usual~Treatment as usual: Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care."
621145|NCT00468650|B1|Baseline|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621146|NCT00468650|P1|Participant Flow|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621147|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621148|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621149|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621233|NCT00468559|E3|Reported Event|Double Blind Placebo|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
638645|NCT00427960|E2|Reported Event|Atorvastatin|atorvastatin 10 mg
621150|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621151|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621152|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621153|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621154|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621155|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621156|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621157|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621158|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621159|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621160|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621161|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621162|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621163|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621164|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621165|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621166|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621167|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621168|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621876|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621169|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621170|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621171|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621172|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621173|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621174|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621175|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621176|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621177|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621178|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621179|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621180|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621181|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621182|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621183|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621184|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621185|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621186|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621187|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621877|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621188|NCT00468650|E1|Reported Event|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
621189|NCT00468585|B5|Baseline|Total|Total of all reporting groups
621190|NCT00468585|B4|Baseline|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
621191|NCT00468585|B3|Baseline|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
621192|NCT00468585|B2|Baseline|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
621193|NCT00468585|B1|Baseline|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
621194|NCT00468585|P4|Participant Flow|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
621195|NCT00468585|P3|Participant Flow|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
621196|NCT00468585|P2|Participant Flow|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
621197|NCT00468585|P1|Participant Flow|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
621198|NCT00468585|O4|Outcome|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
621199|NCT00468585|O3|Outcome|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
621200|NCT00468585|O2|Outcome|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
621201|NCT00468585|O1|Outcome|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
621202|NCT00468585|E4|Reported Event|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
621203|NCT00468585|E3|Reported Event|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
621204|NCT00468585|E2|Reported Event|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
621205|NCT00468585|E1|Reported Event|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
621206|NCT00468559|B3|Baseline|Total|Total of all reporting groups
621207|NCT00468559|B2|Baseline|Double Blind Placebo|
621208|NCT00468559|B1|Baseline|Double Blind Esomeprazole|
621209|NCT00468559|P3|Participant Flow|Double Blind Placebo|
621210|NCT00468559|P2|Participant Flow|Double Blind Esomeprazole|
621211|NCT00468559|P1|Participant Flow|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
621212|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
621213|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
621214|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
621215|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
621216|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
621217|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621218|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
621219|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621220|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
621221|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621222|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
621223|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621224|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
621225|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621226|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
621227|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621228|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
621229|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621230|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
621231|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
621232|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
638646|NCT00427960|E1|Reported Event|Rosuvastatin|rosuvastatin 5 mg
621234|NCT00468559|E2|Reported Event|Double Blind Esomeprazole|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
621235|NCT00468559|E1|Reported Event|Open-label Phase|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight).
621236|NCT00468546|B3|Baseline|Total|Total of all reporting groups
621237|NCT00468546|B2|Baseline|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621238|NCT00468546|B1|Baseline|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621239|NCT00468546|P2|Participant Flow|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621240|NCT00468546|P1|Participant Flow|Placebo Plus Methotrexate|Eligible participants were administered the placebo by intravenous infusion on Days 1 and 15 along with methotrexate (MTX) 10-25 milligrams (mg) per os (p.o.) or parenterally once a week up to Week 24 and were followed up to Week 104.
621241|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621242|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621243|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621244|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621245|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621246|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621247|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621248|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621249|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621250|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621251|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621252|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621253|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621254|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621255|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621256|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621257|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621258|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621259|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621260|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621261|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621262|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
622206|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
621263|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621264|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621265|NCT00468546|E2|Reported Event|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
621266|NCT00468546|E1|Reported Event|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
621267|NCT00468481|B3|Baseline|Total|Total of all reporting groups
621268|NCT00468481|B2|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621269|NCT00468481|B1|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621270|NCT00468481|P2|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621271|NCT00468481|P1|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621272|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621273|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621274|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621275|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621276|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621277|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621278|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621279|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621280|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621281|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621282|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621283|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621284|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621285|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621286|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621287|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621288|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621289|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621370|NCT00468312|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621290|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621291|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621292|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621293|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621294|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621295|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621296|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621297|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621298|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621299|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621300|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621301|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621302|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621303|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621304|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621305|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621306|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621307|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621308|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621309|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621310|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621311|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621312|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621313|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621314|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621315|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621371|NCT00468312|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
622207|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
621316|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621317|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621318|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621319|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621320|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621321|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621322|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621323|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621324|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621325|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621326|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621327|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621328|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621329|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621330|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621331|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621332|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621333|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621334|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621335|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621336|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621337|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621338|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621339|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621340|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621341|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621372|NCT00468312|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621342|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621343|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621344|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621345|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621346|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621347|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621348|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621349|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621350|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621351|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621352|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621353|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621354|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621355|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621356|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621357|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621358|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621359|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621360|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621361|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621362|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621363|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621364|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621365|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621366|NCT00468481|E2|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
621367|NCT00468481|E1|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
621368|NCT00468312|B3|Baseline|Total|Total of all reporting groups
621369|NCT00468312|B2|Baseline|Placebo|Two sprays in each nostril once daily
621374|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621375|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
621376|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621377|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
621378|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621379|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
621380|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621381|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
621382|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621383|NCT00468312|E2|Reported Event|Placebo|Two sprays in each nostril once daily
621384|NCT00468312|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
621385|NCT00468299|B3|Baseline|Total|Total of all reporting groups
621386|NCT00468299|B2|Baseline|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
621387|NCT00468299|B1|Baseline|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
621388|NCT00468299|P2|Participant Flow|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
621389|NCT00468299|P1|Participant Flow|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
621390|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women received mifeppristone 200 mg orally followed ny misoprostol 800 mcg buccally
621391|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women received a placebo followed by misoprostol 800 mcg buccally
621392|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
621393|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
621394|NCT00468299|E2|Reported Event|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
621395|NCT00468299|E1|Reported Event|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
621396|NCT00468286|B3|Baseline|Total|Total of all reporting groups
621397|NCT00468286|B2|Baseline|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621398|NCT00468286|B1|Baseline|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621399|NCT00468286|P2|Participant Flow|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621400|NCT00468286|P1|Participant Flow|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621401|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621402|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621403|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621404|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621405|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621406|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621407|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621408|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621409|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621410|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621411|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621412|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
622208|NCT00467285|E2|Reported Event|No Pioglitazone|Subjects not on pioglitazone
621413|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621414|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621415|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621416|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621417|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621418|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621419|NCT00468286|E2|Reported Event|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621420|NCT00468286|E1|Reported Event|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
621421|NCT00468208|B1|Baseline|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621422|NCT00468208|P1|Participant Flow|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621423|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621424|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621425|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621426|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621427|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621428|NCT00468208|E1|Reported Event|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
621429|NCT00468143|B1|Baseline|All Participants|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
621430|NCT00468143|P2|Participant Flow|Immediate Release First|This group received the immediate release medication during the first three weeks of treatment and then received the extended release medication during the last 3 weeks of treatment.
621431|NCT00468143|P1|Participant Flow|Extended Release First|This group received the extended release medication during the first three weeks of treatment and then received the immediate release medication during the last 3 weeks of treatment.
621455|NCT00468104|O2|Outcome|Placebo|Placebo in 100 cc of normal saline given daily intrapleurally for 3 days either in the first or second arm
621456|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline given intrapleurally daily for 3 days either in the first or second arm
621432|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621433|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621434|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621435|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621436|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621437|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621438|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621439|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621440|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621441|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
621442|NCT00468143|E2|Reported Event|Immediate Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
621443|NCT00468143|E1|Reported Event|Extended Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
621444|NCT00468104|B1|Baseline|Alteplase; Placebo|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally; 100 cc of normal saline instilled intrapleurally
621445|NCT00468104|P2|Participant Flow|Placebo Then Alteplase|Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Alteplase)
621446|NCT00468104|P1|Participant Flow|Alteplase Then Placebo|25 mg of Alteplase in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Placebo)
621447|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
621448|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
621449|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
621450|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
621451|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
621452|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
621453|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
621454|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
621457|NCT00468104|E3|Reported Event|Received Both Alteplase and Placebo|These patients were crossed over and received both Alteplase and Placebo
621458|NCT00468104|E2|Reported Event|Received Placebo Only|These patients received Placebo only and were not crossed over
621459|NCT00468104|E1|Reported Event|Received Alteplase Only|These patients received only Alteplase and were not crossed over
621460|NCT00468052|B3|Baseline|Total|Total of all reporting groups
621461|NCT00468052|B2|Baseline|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
621462|NCT00468052|B1|Baseline|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
621463|NCT00468052|P2|Participant Flow|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
621464|NCT00468052|P1|Participant Flow|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
621465|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
621466|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
621467|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
621468|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
621469|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
621470|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
621471|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
621472|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
621473|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
621474|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
621475|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
621476|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
621477|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
621478|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
621479|NCT00468052|E2|Reported Event|Dexmedetomidine|1 subjects Group D experienced an adverse event.
621480|NCT00468052|E1|Reported Event|Fentanyl (F) Group|"No subjects in group F experienced an adverse event.~0"
621481|NCT00467961|B1|Baseline|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
621482|NCT00467961|P1|Participant Flow|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
621483|NCT00467961|O1|Outcome|Selective T Cell Depletion Transplant Recipients|"Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach (Kiadis Pharma). Older subjects will receive a lower dose of irradiation to reduce the regimen intensity.~To determine appropriate level of post transplant immunosuppression."
621484|NCT00467961|E1|Reported Event|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
621485|NCT00467896|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
621486|NCT00467896|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
621487|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) in Period I and Power Disc-15 (PD-15)in Period II.
621488|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621489|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621490|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621491|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621492|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621493|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621494|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621495|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621496|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621497|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621498|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621499|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621500|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621501|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621502|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621503|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
621504|NCT00467896|E1|Reported Event|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
621505|NCT00467870|B7|Baseline|Total|Total of all reporting groups
621506|NCT00467870|B6|Baseline|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621507|NCT00467870|B5|Baseline|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621508|NCT00467870|B4|Baseline|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
621509|NCT00467870|B3|Baseline|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
621510|NCT00467870|B2|Baseline|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
621511|NCT00467870|B1|Baseline|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
621512|NCT00467870|P6|Participant Flow|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621513|NCT00467870|P5|Participant Flow|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621514|NCT00467870|P4|Participant Flow|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
621515|NCT00467870|P3|Participant Flow|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
621516|NCT00467870|P2|Participant Flow|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
621517|NCT00467870|P1|Participant Flow|A-TU 750 mg|750 mg testosterone undecanoate (TU) in 3 mL oily solution, intramuscularly (IM) every 12 weeks for up to 3 years in Part A
621518|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621519|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621520|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621521|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621522|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621523|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621524|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621525|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621526|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621527|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621528|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621529|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621530|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621531|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621532|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621596|NCT00467844|P3|Participant Flow|3 mg of Placebo|Placebo
621533|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621534|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621535|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621536|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621537|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621538|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621539|NCT00467870|O2|Outcome|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
621540|NCT00467870|O1|Outcome|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
621541|NCT00467870|O2|Outcome|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
621542|NCT00467870|O1|Outcome|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
621543|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621544|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621545|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621546|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
621547|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621548|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621549|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621550|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621551|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621552|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621553|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621554|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
621555|NCT00467870|E2|Reported Event|TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at any time during the study in Part A or B (includes participants from A-1000 mg, B-750 mg, and B-1000 mg)
621556|NCT00467870|E1|Reported Event|TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline and during the study in Part A, C, or C2 (includes participants from A-750 mg, C-750 mg, and C2-750 mg)
621557|NCT00467857|B3|Baseline|Total|Total of all reporting groups
621558|NCT00467857|B2|Baseline|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621559|NCT00467857|B1|Baseline|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621560|NCT00467857|P2|Participant Flow|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621561|NCT00467857|P1|Participant Flow|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621562|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621563|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621564|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621565|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621566|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621567|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621568|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621597|NCT00467844|P2|Participant Flow|GTx-024|3 mg
621569|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621570|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621571|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621572|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621573|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621574|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621575|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621576|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621577|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621578|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621579|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621580|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621581|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621582|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621583|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621584|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621585|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621586|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621587|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621588|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621589|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621590|NCT00467857|E2|Reported Event|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
621591|NCT00467857|E1|Reported Event|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
621592|NCT00467844|B4|Baseline|Total|Total of all reporting groups
621593|NCT00467844|B3|Baseline|3 mg of Placebo|Placebo
621594|NCT00467844|B2|Baseline|GTx-024|3 mg
621595|NCT00467844|B1|Baseline|GTx -024|1 mg
621608|NCT00467831|B1|Baseline|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
621609|NCT00467831|P1|Participant Flow|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
621610|NCT00467831|O1|Outcome|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
621611|NCT00467831|E1|Reported Event|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
621612|NCT00467779|B16|Baseline|Total|Total of all reporting groups
621613|NCT00467779|B15|Baseline|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621614|NCT00467779|B14|Baseline|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621615|NCT00467779|B13|Baseline|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621616|NCT00467779|B12|Baseline|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621617|NCT00467779|B11|Baseline|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621618|NCT00467779|B10|Baseline|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621619|NCT00467779|B9|Baseline|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621620|NCT00467779|B8|Baseline|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621621|NCT00467779|B7|Baseline|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621622|NCT00467779|B6|Baseline|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621623|NCT00467779|B5|Baseline|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621624|NCT00467779|B4|Baseline|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621878|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621625|NCT00467779|B3|Baseline|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621626|NCT00467779|B2|Baseline|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621627|NCT00467779|B1|Baseline|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621628|NCT00467779|P15|Participant Flow|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621629|NCT00467779|P14|Participant Flow|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621630|NCT00467779|P13|Participant Flow|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621631|NCT00467779|P12|Participant Flow|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621632|NCT00467779|P11|Participant Flow|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621633|NCT00467779|P10|Participant Flow|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621634|NCT00467779|P9|Participant Flow|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621635|NCT00467779|P8|Participant Flow|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621636|NCT00467779|P7|Participant Flow|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621637|NCT00467779|P6|Participant Flow|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621638|NCT00467779|P5|Participant Flow|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621639|NCT00467779|P4|Participant Flow|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621640|NCT00467779|P3|Participant Flow|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621641|NCT00467779|P2|Participant Flow|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621642|NCT00467779|P1|Participant Flow|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 milligrams per kilograms (mg/kg) via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621659|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621643|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621644|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621645|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621646|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621647|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621648|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
621649|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621650|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621651|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621652|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621653|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621654|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621655|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621656|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621657|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621658|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621660|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621661|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621662|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621663|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621664|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621665|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621666|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621667|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621668|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621669|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621670|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621671|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621672|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621673|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621674|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621675|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621676|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621677|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621678|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621679|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
622209|NCT00467285|E1|Reported Event|Pioglitazone|Subjects on pioglitazone
621680|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621681|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621682|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621683|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621684|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621685|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621686|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621687|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621688|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621689|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621690|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621691|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621692|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621693|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621694|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621695|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621696|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621697|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621698|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621699|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621700|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621701|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621702|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621703|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621704|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621705|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621706|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621707|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621708|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621709|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621710|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621711|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621712|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621713|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621714|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621715|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621716|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621717|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621718|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621719|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
622203|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
621720|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621721|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621722|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621723|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621724|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621725|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621726|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621727|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621728|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621729|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621730|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621731|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621732|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621733|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621734|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621735|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621736|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621737|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621738|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621739|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621869|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
622210|NCT00467259|B3|Baseline|Total|Total of all reporting groups
621740|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621741|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621742|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621743|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621744|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621745|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621746|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621747|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621748|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621749|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621750|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621751|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621752|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621753|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621754|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621755|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621756|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621757|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621758|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621759|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621760|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621761|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621762|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621763|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621764|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621765|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621766|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621767|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621768|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621769|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621770|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621771|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621772|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621773|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621774|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621775|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621776|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621777|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621778|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621779|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621870|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
638647|NCT00427934|B5|Baseline|Total|Total of all reporting groups
621780|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621781|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621782|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621783|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621784|NCT00467779|O1|Outcome|Stage 1A - All Cohorts (14/14)|Participants received cobimetinib via solution or capsule, once daily for Days 1-14 of each 28-day cycle and were on a 14-days-on and 14-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621785|NCT00467779|O1|Outcome|Stage 1 All Cohorts (21/7)|Participants received cobimetinib via solution or capsule, once daily for Days 1-21 of each 28-day cycle and were on 21-days-on and 7-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621786|NCT00467779|O12|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621787|NCT00467779|O11|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621788|NCT00467779|O10|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621789|NCT00467779|O9|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621790|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621791|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621792|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621793|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621794|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621795|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621796|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621797|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621798|NCT00467779|E15|Reported Event|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period. Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
622771|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
621799|NCT00467779|E14|Reported Event|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621800|NCT00467779|E13|Reported Event|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621801|NCT00467779|E12|Reported Event|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621802|NCT00467779|E11|Reported Event|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621803|NCT00467779|E10|Reported Event|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621804|NCT00467779|E9|Reported Event|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621805|NCT00467779|E8|Reported Event|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621806|NCT00467779|E7|Reported Event|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621807|NCT00467779|E6|Reported Event|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621808|NCT00467779|E5|Reported Event|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621809|NCT00467779|E4|Reported Event|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621810|NCT00467779|E3|Reported Event|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621811|NCT00467779|E2|Reported Event|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621812|NCT00467779|E1|Reported Event|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
621813|NCT00467753|B3|Baseline|Total|Total of all reporting groups
621814|NCT00467753|B2|Baseline|Sugar Pill|Placebo : Dosage similar to active drug
621815|NCT00467753|B1|Baseline|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
621816|NCT00467753|P2|Participant Flow|Sugar Pill|Placebo : Dosage similar to active drug
621817|NCT00467753|P1|Participant Flow|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
621818|NCT00467753|O2|Outcome|Sugar Pill|Placebo : Dosage similar to active drug
621871|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621872|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621873|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
622864|NCT00465530|B3|Baseline|Total|Total of all reporting groups
621819|NCT00467753|O1|Outcome|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
621820|NCT00467753|E2|Reported Event|Sugar Pill|Placebo : Dosage similar to active drug
621821|NCT00467753|E1|Reported Event|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
621822|NCT00467740|B6|Baseline|Total|Total of all reporting groups
621823|NCT00467740|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621824|NCT00467740|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621825|NCT00467740|B3|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621826|NCT00467740|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621827|NCT00467740|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621828|NCT00467740|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621829|NCT00467740|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621830|NCT00467740|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621831|NCT00467740|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621832|NCT00467740|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621833|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621834|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621835|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621836|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621837|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621838|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621839|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621840|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621841|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621842|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621843|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621844|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621845|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621846|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621847|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621848|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621849|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621850|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621851|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621852|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621853|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621854|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621855|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621856|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621857|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621858|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621859|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621860|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621861|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621862|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621863|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621864|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621865|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621866|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621867|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621868|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621879|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621880|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621881|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621882|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621883|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621884|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621885|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621886|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621887|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621888|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621889|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621890|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621891|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621892|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621893|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621894|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621895|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621896|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621897|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621898|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621899|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621900|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621901|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621902|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621903|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621904|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621905|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621906|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621907|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621908|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621909|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621910|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621911|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621912|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621913|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621914|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621915|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621916|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621917|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621918|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621919|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621920|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621921|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621922|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621923|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621924|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621925|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621926|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621927|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621928|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621929|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621930|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621931|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621932|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621933|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621934|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621935|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621936|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621937|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621938|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621939|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621940|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621941|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621942|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621943|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621944|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621945|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621946|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621947|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621948|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621949|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621950|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621951|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621952|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621953|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621954|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621955|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621956|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621957|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621958|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621959|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621960|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621961|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621962|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621963|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621964|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621965|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621966|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621967|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621968|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621969|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621970|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621971|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621972|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621973|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621974|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621975|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621976|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621977|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621978|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621979|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621980|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621981|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621982|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621983|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621984|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621985|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621986|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621987|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621988|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621989|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621990|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621991|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621992|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621993|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621994|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
621995|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
621996|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
621997|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
621998|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
621999|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
622000|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
622001|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
622002|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
622003|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
622004|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
622005|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
622006|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
622007|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
622008|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
622009|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
622010|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
622011|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
622012|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
622013|NCT00467740|E5|Reported Event|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
622014|NCT00467740|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
622015|NCT00467740|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
622016|NCT00467740|E2|Reported Event|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
622017|NCT00467740|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
622018|NCT00467649|B3|Baseline|Total|Total of all reporting groups
622019|NCT00467649|B2|Baseline|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622020|NCT00467649|B1|Baseline|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622021|NCT00467649|P6|Participant Flow|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
622022|NCT00467649|P5|Participant Flow|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622023|NCT00467649|P4|Participant Flow|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
622024|NCT00467649|P3|Participant Flow|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622025|NCT00467649|P2|Participant Flow|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622026|NCT00467649|P1|Participant Flow|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622027|NCT00467649|O6|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
622028|NCT00467649|O5|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622029|NCT00467649|O4|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
622030|NCT00467649|O3|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622031|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622032|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622033|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
622034|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622035|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
622036|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622037|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
622038|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622039|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
622040|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622041|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622042|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622204|NCT00467285|O2|Outcome|Baseline Characteristics: Group 2|Mean age of 49 with mean BMI 0f 35.2 ± 5; HbA1C of 7.45
622043|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622044|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622045|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622046|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622047|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622048|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622049|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622050|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622051|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622052|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622053|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622054|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622055|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622056|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622057|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622058|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622059|NCT00467649|E6|Reported Event|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
622060|NCT00467649|E5|Reported Event|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622061|NCT00467649|E4|Reported Event|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
622062|NCT00467649|E3|Reported Event|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
622063|NCT00467649|E2|Reported Event|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
622064|NCT00467649|E1|Reported Event|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
622065|NCT00467610|B1|Baseline|Group 1|Panhematin treatment arm
622066|NCT00467610|P1|Participant Flow|Group 1|Panhematin treatment arm
622067|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
622068|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
622069|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
622070|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
622071|NCT00467610|E1|Reported Event|Group 1|Panhematin treatment arm
622072|NCT00467597|B5|Baseline|Total|Total of all reporting groups
622073|NCT00467597|B4|Baseline|Controls - No PD|Controls with no Parkinson's disease
622074|NCT00467597|B3|Baseline|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
622075|NCT00467597|B2|Baseline|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
622076|NCT00467597|B1|Baseline|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
622077|NCT00467597|P2|Participant Flow|Controls|Non-Parkinson's Disease Controls (no intervention).
622078|NCT00467597|P1|Participant Flow|Parkinson's Disease|Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention).
622079|NCT00467597|O4|Outcome|Controls - No PD|Controls with no Parkinson's disease
622080|NCT00467597|O3|Outcome|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
622081|NCT00467597|O2|Outcome|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
622082|NCT00467597|O1|Outcome|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
622083|NCT00467597|E4|Reported Event|Controls - No PD|Controls with no Parkinson's disease
622084|NCT00467597|E3|Reported Event|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
622085|NCT00467597|E2|Reported Event|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
622086|NCT00467597|E1|Reported Event|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
622087|NCT00467584|B4|Baseline|Total|Total of all reporting groups
622088|NCT00467584|B3|Baseline|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
622089|NCT00467584|B2|Baseline|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
622090|NCT00467584|B1|Baseline|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
622091|NCT00467584|P3|Participant Flow|Placebo|"Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks~Placebo: Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks"
622092|NCT00467584|P2|Participant Flow|Low Dose Aspirin|"Low Dose Aspirin; 162 milligrams of aspirin per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks~Low Dose Aspirin (162 mg/day): 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
622093|NCT00467584|P1|Participant Flow|High Dose Aspirin|"High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks~High Dose Aspirin (1300 mg/day): 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
622094|NCT00467584|O3|Outcome|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
622095|NCT00467584|O2|Outcome|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
622096|NCT00467584|O1|Outcome|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
622097|NCT00467584|E3|Reported Event|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
622098|NCT00467584|E2|Reported Event|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
622099|NCT00467584|E1|Reported Event|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
622100|NCT00467558|B3|Baseline|Total|Total of all reporting groups
622101|NCT00467558|B2|Baseline|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
622102|NCT00467558|B1|Baseline|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
622103|NCT00467558|P2|Participant Flow|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
622104|NCT00467558|P1|Participant Flow|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
622105|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
622106|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
622107|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
622108|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
622109|NCT00467558|E2|Reported Event|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
622110|NCT00467558|E1|Reported Event|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
622111|NCT00467519|B3|Baseline|Total|Total of all reporting groups
622112|NCT00467519|B2|Baseline|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622113|NCT00467519|B1|Baseline|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622114|NCT00467519|P2|Participant Flow|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622115|NCT00467519|P1|Participant Flow|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622116|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622117|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622118|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622119|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622120|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622121|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622122|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622123|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622124|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622125|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622205|NCT00467285|O1|Outcome|Baseline Characteristics: Group 1|Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
622126|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622127|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622128|NCT00467519|E2|Reported Event|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
622129|NCT00467519|E1|Reported Event|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
622130|NCT00467389|B1|Baseline|All Participants|All recruited subjects
622131|NCT00467389|P2|Participant Flow|Donepezil Treatment First|Participants initially treated with oral donepezil, and later treated with oral placebo
622132|NCT00467389|P1|Participant Flow|Placebo Treatment First|Participants initially treated with oral placebo, and later treated with oral donepezil
622133|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
622134|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
622135|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
622136|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
622137|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
622138|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
622139|NCT00467389|E2|Reported Event|Donepezil Treatment Period|Active Treatment
622140|NCT00467389|E1|Reported Event|Placebo Treatment Period|Inactive Comparator.
622141|NCT00467363|B3|Baseline|Total|Total of all reporting groups
622142|NCT00467363|B2|Baseline|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622143|NCT00467363|B1|Baseline|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622144|NCT00467363|P2|Participant Flow|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622145|NCT00467363|P1|Participant Flow|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622146|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622147|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622148|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622149|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622150|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622151|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622152|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622153|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622154|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622155|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622156|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622157|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622158|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622159|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622160|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622161|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622162|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622163|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622164|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622165|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622166|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622167|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622168|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622169|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622170|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622171|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622172|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622865|NCT00465530|B2|Baseline|Saline (Once Daily, 40 mL to Each Nostril)|
622173|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622174|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622175|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622176|NCT00467363|E2|Reported Event|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
622177|NCT00467363|E1|Reported Event|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
622178|NCT00467298|B3|Baseline|Total|Total of all reporting groups
622179|NCT00467298|B2|Baseline|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
622180|NCT00467298|B1|Baseline|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
622181|NCT00467298|P2|Participant Flow|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
622182|NCT00467298|P1|Participant Flow|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
622183|NCT00467298|O2|Outcome|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
622184|NCT00467298|O1|Outcome|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
622185|NCT00467298|O2|Outcome|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
622186|NCT00467298|O1|Outcome|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
622187|NCT00467298|E2|Reported Event|Usual Care|Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
622188|NCT00467298|E1|Reported Event|Self-management|"Novel intensive self-management education and exercise program of four weeks~Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.~Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.~Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions."
622189|NCT00467285|B3|Baseline|Total|Total of all reporting groups
622190|NCT00467285|B2|Baseline|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
622191|NCT00467285|B1|Baseline|Pioglitazone|32 subjects with type 2 diabetes on pioglitazone.
622192|NCT00467285|P2|Participant Flow|Group 2|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
622193|NCT00467285|P1|Participant Flow|Group 1|32 subjects with type 2 diabetes on pioglitazone.
622194|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
622195|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
622196|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
622197|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
622198|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
622199|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
622200|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
622201|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
622202|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
622211|NCT00467259|B2|Baseline|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
622212|NCT00467259|B1|Baseline|Placebo|Placebo patch
622213|NCT00467259|P2|Participant Flow|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
622214|NCT00467259|P1|Participant Flow|Placebo|Placebo patch
622215|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
622216|NCT00467259|O1|Outcome|Placebo|Placebo patch
622217|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
622218|NCT00467259|O1|Outcome|Placebo|Placebo patch
622219|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
622220|NCT00467259|O1|Outcome|Placebo|Placebo patch
622221|NCT00467259|E2|Reported Event|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
622222|NCT00467259|E1|Reported Event|Placebo|Placebo patch
622223|NCT00467077|B1|Baseline|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
622224|NCT00467077|P1|Participant Flow|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
622225|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
622226|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
622227|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
622228|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
622229|NCT00467077|E1|Reported Event|Arm 1|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
622230|NCT00467051|B1|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
622231|NCT00467051|P1|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
622232|NCT00467051|O1|Outcome|Experimental|
622233|NCT00467051|O1|Outcome|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
622234|NCT00467051|E1|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
622235|NCT00467038|B3|Baseline|Total|Total of all reporting groups
622236|NCT00467038|B2|Baseline|Healthy Controls|"Healthy controls~Age and gender matched healthy volunteers"
622530|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622237|NCT00467038|B1|Baseline|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD~Event-related fMRI was obtained pre- and post-12-months of standard-DBT in unmedicatedBPD patients."
622238|NCT00467038|P2|Participant Flow|Healthy Controls|Healthy controls- no intervention
622239|NCT00467038|P1|Participant Flow|Dialectical Behavior Therapy|Participants receiving Dialectical Behavior Therapy
622240|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
622241|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
622242|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
622243|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
622244|NCT00467038|E2|Reported Event|Arm 2|Healthy controls- no intervention
622245|NCT00467038|E1|Reported Event|Arm 1|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
622246|NCT00466960|B1|Baseline|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622247|NCT00466960|P1|Participant Flow|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622248|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622249|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622250|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622251|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622252|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622531|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622253|NCT00466960|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622254|NCT00466960|E1|Reported Event|Treatment (Colony Stimulating Factor and Chemotherapy)|"INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~sargramostim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~laboratory biomarker analysis: Correlative studies~immunologic technique: Correlative studies"
622255|NCT00466947|B3|Baseline|Total|Total of all reporting groups
622256|NCT00466947|B2|Baseline|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622257|NCT00466947|B1|Baseline|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622258|NCT00466947|P2|Participant Flow|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622259|NCT00466947|P1|Participant Flow|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622260|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622261|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622262|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622263|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622264|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622265|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622266|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622267|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622268|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622269|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622270|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622449|NCT00466752|O2|Outcome|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
642072|NCT00420992|E1|Reported Event|ALO-01|
622271|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622272|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622273|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622274|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622275|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622276|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622277|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622278|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622279|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622280|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622281|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622282|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622283|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622284|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622285|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622286|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622287|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622288|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622289|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622290|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622291|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622292|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622293|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622294|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622295|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622296|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622297|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622298|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622299|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622300|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622301|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622302|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622303|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622304|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622305|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622306|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622307|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622308|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622309|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622310|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622311|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622312|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622313|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622314|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622315|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622316|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622317|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622318|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622319|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622320|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622321|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622322|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622323|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622324|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622325|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622326|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622327|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622328|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622329|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622330|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622331|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622332|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622333|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622334|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622335|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622336|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622337|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622338|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622339|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622340|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622341|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622342|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622343|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622344|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622345|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622346|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622347|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622348|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622349|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622350|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622351|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622352|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622353|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622354|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622355|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622356|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622357|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622358|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622359|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622360|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622361|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622362|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622363|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622364|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622365|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622366|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622367|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622368|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622369|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622370|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622371|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622372|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622373|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622374|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622375|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622376|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622377|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622378|NCT00466947|E2|Reported Event|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
622379|NCT00466947|E1|Reported Event|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
622380|NCT00466882|B1|Baseline|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
622381|NCT00466882|P1|Participant Flow|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
622382|NCT00466882|O1|Outcome|Group 1|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
622383|NCT00466882|E1|Reported Event|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
622384|NCT00466817|B3|Baseline|Total|Total of all reporting groups
622385|NCT00466817|B2|Baseline|Valganciclovir: 24 Wks of Valganciclovir|"Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622386|NCT00466817|B1|Baseline|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622387|NCT00466817|P2|Participant Flow|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622388|NCT00466817|P1|Participant Flow|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622389|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622450|NCT00466752|O1|Outcome|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
622390|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622391|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622392|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622393|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622394|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622395|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Vlaganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622396|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622397|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622398|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622399|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622400|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622401|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622402|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622403|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622404|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622405|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622406|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622451|NCT00466752|E2|Reported Event|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
622657|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622407|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622408|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622409|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622410|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622411|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622412|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622413|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622414|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622415|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622416|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622417|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622418|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622419|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622420|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622421|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622422|NCT00466817|O1|Outcome|Placebo: 6 Wks of Vlaganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622423|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622424|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622425|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622426|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622427|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622428|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622429|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622430|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622431|NCT00466817|O2|Outcome|Valganciclovir: 24 Weeks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622432|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622433|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622434|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622435|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
622436|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
622437|NCT00466817|E3|Reported Event|Placebo After 6 Weeks of Valganciclovir|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
622438|NCT00466817|E2|Reported Event|Active|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir
622439|NCT00466817|E1|Reported Event|Non Randomized|6 weeks of open label valganciclovir only
622440|NCT00466752|B3|Baseline|Total|Total of all reporting groups
622441|NCT00466752|B2|Baseline|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
622442|NCT00466752|B1|Baseline|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
622443|NCT00466752|P2|Participant Flow|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
622444|NCT00466752|P1|Participant Flow|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
622445|NCT00466752|O2|Outcome|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
622446|NCT00466752|O1|Outcome|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
622447|NCT00466752|O2|Outcome|24 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 42 days prior to radical prostatectomy. Last dose of study drug is the morning dose the day prior to surgery.
622448|NCT00466752|O1|Outcome|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
622528|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622452|NCT00466752|E1|Reported Event|48 Hour Drug Stop Point|Sorafenib 400mg taken orally twice per day for 41 days prior to radical prostatectomy. Last dose of study drug is the morning dose 2 days prior to surgery.
622453|NCT00466687|B1|Baseline|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
622454|NCT00466687|P1|Participant Flow|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
622455|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
622456|NCT00466687|O1|Outcome|Therapeutic Intervention|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
622457|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
622458|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
622459|NCT00466687|E1|Reported Event|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
622460|NCT00466505|B1|Baseline|Therapeutic Intervention|
622461|NCT00466505|P1|Participant Flow|Therapeutic Intervention|
622462|NCT00466505|O1|Outcome|Therapeutic Intervention|
622463|NCT00466505|O1|Outcome|Therapeutic Intervention|
622464|NCT00466505|O1|Outcome|Therapeutic Intervention|
622465|NCT00466505|O1|Outcome|Therapeutic Intervention|
622466|NCT00466505|O1|Outcome|Therapeutic Intervention|
622467|NCT00466505|O1|Outcome|Therapeutic Intervention|
622468|NCT00466505|O1|Outcome|Therapeutic Intervention|
622469|NCT00466505|O1|Outcome|Therapeutic Intervention|
622470|NCT00466505|O1|Outcome|Therapeutic Intervention|
622471|NCT00466505|E1|Reported Event|Therapeutic Intervention|
622472|NCT00466323|B3|Baseline|Total|Total of all reporting groups
622473|NCT00466323|B2|Baseline|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
622474|NCT00466323|B1|Baseline|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
622475|NCT00466323|P2|Participant Flow|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
622476|NCT00466323|P1|Participant Flow|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
622477|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
622478|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
622479|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
622480|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
622481|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
622482|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
622529|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622483|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
622484|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
622485|NCT00466323|E2|Reported Event|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
622486|NCT00466323|E1|Reported Event|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
622487|NCT00466310|B4|Baseline|Total|Total of all reporting groups
622488|NCT00466310|B3|Baseline|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
622489|NCT00466310|B2|Baseline|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
622490|NCT00466310|B1|Baseline|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
622491|NCT00466310|P3|Participant Flow|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
622492|NCT00466310|P2|Participant Flow|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
622493|NCT00466310|P1|Participant Flow|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
622494|NCT00466310|O3|Outcome|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
622495|NCT00466310|O2|Outcome|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
622496|NCT00466310|O1|Outcome|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
622497|NCT00466310|E3|Reported Event|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
622498|NCT00466310|E2|Reported Event|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
622499|NCT00466310|E1|Reported Event|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
622500|NCT00466206|B1|Baseline|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
622501|NCT00466206|P1|Participant Flow|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
622502|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
622503|NCT00466206|O1|Outcome|3MP Treatment Arm|Pectus excavatum treated with Magnetic Mini-Mover Procedure. Active treatment = 18 months
622504|NCT00466206|O1|Outcome|3MP Treatment Group|Treatment of pectus excavatum with the Magnetic Mini-Mover Procedure
622505|NCT00466206|O1|Outcome|Treatment Arm|Magnetic Mini-Mover Procedure
622506|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
622507|NCT00466206|E1|Reported Event|Magnetic Mini-Mover Treatment|Use of the Magnimplant and Magnatract to treat pectus excavatum
622508|NCT00466193|B3|Baseline|Total|Total of all reporting groups
622509|NCT00466193|B2|Baseline|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622510|NCT00466193|B1|Baseline|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622511|NCT00466193|P2|Participant Flow|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622512|NCT00466193|P1|Participant Flow|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622513|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622514|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622515|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622516|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622517|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622518|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622519|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622520|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622521|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622522|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622523|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622524|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622525|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622526|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622527|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622532|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622533|NCT00466193|E2|Reported Event|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
622534|NCT00466193|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
622535|NCT00466167|B4|Baseline|Total|Total of all reporting groups
622536|NCT00466167|B3|Baseline|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622537|NCT00466167|B2|Baseline|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622538|NCT00466167|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622539|NCT00466167|P3|Participant Flow|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622540|NCT00466167|P2|Participant Flow|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622541|NCT00466167|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622542|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622543|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622544|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622545|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622546|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622547|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622548|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622549|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622550|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622551|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622552|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622553|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622554|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622555|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622556|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622557|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622558|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622559|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622560|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622561|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622562|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622563|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622564|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622565|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622566|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622567|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622568|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622569|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622570|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622571|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622572|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622573|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622574|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622575|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622576|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622577|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
642073|NCT00420927|B8|Baseline|Total|Total of all reporting groups
622578|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622579|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622580|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622581|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622582|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622583|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622584|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622585|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622586|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622587|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622588|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622589|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622590|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622591|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622592|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622593|NCT00466167|E3|Reported Event|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
622594|NCT00466167|E2|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
622595|NCT00466167|E1|Reported Event|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
622596|NCT00465998|B1|Baseline|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
622597|NCT00465998|P1|Participant Flow|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
622598|NCT00465998|O1|Outcome|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
622599|NCT00465998|O1|Outcome|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
622600|NCT00465998|E1|Reported Event|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
622601|NCT00465985|B1|Baseline|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622602|NCT00465985|P2|Participant Flow|Placebo|Placebo subcutaneous injection every 8 weeks.
622603|NCT00465985|P1|Participant Flow|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622604|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622605|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
622606|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622607|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622608|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
622609|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622610|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622611|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
622612|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622613|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
622614|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622615|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622616|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
622617|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622618|NCT00465985|E5|Reported Event|Entire Study ACZ885|Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
622619|NCT00465985|E4|Reported Event|Part III ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622620|NCT00465985|E3|Reported Event|Part II Placebo|Placebo subcutaneous injection every 8 weeks.
622621|NCT00465985|E2|Reported Event|Part II ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622622|NCT00465985|E1|Reported Event|Part I ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
622623|NCT00465972|B3|Baseline|Total|Total of all reporting groups
622624|NCT00465972|B2|Baseline|Temazepam|1 15 mg pill taken nightly at bedtime.
622625|NCT00465972|B1|Baseline|Placebo|1 sugar pill taken nightly at bedtime.
622626|NCT00465972|P2|Participant Flow|Temazepam|One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.
622627|NCT00465972|P1|Participant Flow|Placebo|One sugar pill taken orally at bedtime for duration of the participant's involvement.
622628|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill taken nightly at bedtime.
622629|NCT00465972|O1|Outcome|Placebo|1 sugar taken nightly at bedtime.
622630|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill of temazepam taken orally at bedtime.
622631|NCT00465972|O1|Outcome|Placebo|1 sugar pill taken orally at bedtime.
622632|NCT00465972|E2|Reported Event|Temazepam|1 15 mg pill taken orally, nightly, at bedtime.
622633|NCT00465972|E1|Reported Event|Placebo|1 sugar pill taken nightly at bedtime.
622634|NCT00465894|B3|Baseline|Total|Total of all reporting groups
622635|NCT00465894|B2|Baseline|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
622636|NCT00465894|B1|Baseline|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
622637|NCT00465894|P2|Participant Flow|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
622638|NCT00465894|P1|Participant Flow|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
622639|NCT00465894|O2|Outcome|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
622640|NCT00465894|O1|Outcome|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
622641|NCT00465894|E2|Reported Event|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
622642|NCT00465894|E1|Reported Event|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12-weeks
622643|NCT00465816|B4|Baseline|Total|Total of all reporting groups
622644|NCT00465816|B3|Baseline|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622645|NCT00465816|B2|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622646|NCT00465816|B1|Baseline|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622647|NCT00465816|P3|Participant Flow|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622648|NCT00465816|P2|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622649|NCT00465816|P1|Participant Flow|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622650|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622651|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622652|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622653|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622654|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622655|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622656|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622658|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622659|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622660|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622661|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622662|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622663|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622664|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622665|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622666|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622667|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622668|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622669|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622670|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622671|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622672|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622673|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622674|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622675|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622676|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622677|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622678|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622679|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622680|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622681|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622682|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622683|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622684|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622685|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622686|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622687|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622688|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622689|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622690|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622691|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622692|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622693|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622694|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622695|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622696|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622697|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622698|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622699|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622700|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622701|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622702|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622703|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622704|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622705|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622706|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622707|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622708|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622709|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622710|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622711|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622712|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622713|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622714|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622715|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622716|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622717|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622718|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622719|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622720|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622721|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622722|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622723|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622724|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622725|NCT00465816|E3|Reported Event|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622726|NCT00465816|E2|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
622727|NCT00465816|E1|Reported Event|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
622728|NCT00465738|B3|Baseline|Total|Total of all reporting groups
622729|NCT00465738|B2|Baseline|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622730|NCT00465738|B1|Baseline|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622731|NCT00465738|P2|Participant Flow|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622732|NCT00465738|P1|Participant Flow|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622733|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622734|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622735|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622736|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622737|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622738|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622739|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622740|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622741|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622742|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622743|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622744|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622745|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622746|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622747|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622748|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622749|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622750|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622751|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622752|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622753|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622754|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622755|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622756|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622757|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622758|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622759|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622760|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622761|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622762|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622763|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622764|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622765|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622766|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622767|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622768|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622769|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622770|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622772|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622773|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622774|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622775|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622776|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622777|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622778|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622779|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622780|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622781|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622782|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622783|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622784|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622785|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622786|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622787|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622788|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622789|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622790|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622791|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622792|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622793|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622794|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622795|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622796|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622797|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622798|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622799|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622800|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622801|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622802|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622803|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622804|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622805|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622806|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622807|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622808|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622809|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622810|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622811|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622812|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622813|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622814|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622815|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622816|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622817|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622818|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622819|NCT00465738|E2|Reported Event|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
622820|NCT00465738|E1|Reported Event|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
622821|NCT00465647|B5|Baseline|Total|Total of all reporting groups
622822|NCT00465647|B4|Baseline|≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622823|NCT00465647|B3|Baseline|≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622824|NCT00465647|B2|Baseline|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622825|NCT00465647|B1|Baseline|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622826|NCT00465647|P4|Participant Flow|≥ 12 Years to < 17 Years|Adolescent- received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622827|NCT00465647|P3|Participant Flow|≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622866|NCT00465530|B1|Baseline|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
622867|NCT00465530|P2|Participant Flow|Saline (Once Daily, 40 mL to Each Nostril)|
622828|NCT00465647|P2|Participant Flow|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622829|NCT00465647|P1|Participant Flow|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622830|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622831|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child (Data for this group not collected. Test not appropriate for this age)
622832|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child (Data for this group not collected. Test not appropriate for this age)
622833|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
622834|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
622835|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622836|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622837|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
622838|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
622839|NCT00465647|O3|Outcome|Oral ≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622840|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622841|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622842|NCT00465647|O1|Outcome|All Patients|A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.
622843|NCT00465647|E8|Reported Event|Parenteral ≥ 12 Years to < 17 Years|Adolescent - received parenteral analgesia up to 48 hours postsurgery.
622844|NCT00465647|E7|Reported Event|Parenteral ≥ 5 Years to < 12 Years|Older child - received parenteral analgesia up to 48 hours postsurgery.
622845|NCT00465647|E6|Reported Event|Parenteral ≥ 13 Months to < 5 Years|Young child - received parenteral analgesia up to 48 hours postsurgery.
622846|NCT00465647|E5|Reported Event|Parenteral ≥ 28 Days to < 13 Months|Infant and toddler - received parenteral analgesia up to 48 hours postsurgery.
622847|NCT00465647|E4|Reported Event|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622848|NCT00465647|E3|Reported Event|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622849|NCT00465647|E2|Reported Event|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622850|NCT00465647|E1|Reported Event|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
622851|NCT00465569|B3|Baseline|Total|Total of all reporting groups
622852|NCT00465569|B2|Baseline|Placebo|Placebo
622853|NCT00465569|B1|Baseline|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
622854|NCT00465569|P2|Participant Flow|Placebo|Pre-measured doses of ProFree, a dry, milk free powder
622855|NCT00465569|P1|Participant Flow|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
622856|NCT00465569|O2|Outcome|Placebo|Placebo
622857|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
622858|NCT00465569|O2|Outcome|Placebo|Placebo
622859|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
622860|NCT00465569|O2|Outcome|Placebo|Placebo
622861|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
622862|NCT00465569|E2|Reported Event|Placebo|Adverse event information is based on percentages of doses. There were 1193 total doses in the placebo arm with a median of 171 and a range of 152-199 per participant. There was a total of 7 participants in the placebo arm who were analyzed for the Adverse Events data reported below.
622863|NCT00465569|E1|Reported Event|Active Treatment|Adverse event information is based on percentages of doses. There were 2437 total doses in the active treatment arm with a median of 177 and a range of 155-242 per participant. There was a total of 13 participants in the active treatment arm who were analyzed for the Adverse Events data reported below.
622868|NCT00465530|P1|Participant Flow|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
622869|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
622870|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
622871|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
622872|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
622873|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
622874|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
622875|NCT00465530|E2|Reported Event|Saline (Once Daily, 40 mL to Each Nostril)|
622876|NCT00465530|E1|Reported Event|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
622877|NCT00465361|B1|Baseline|Intervention|Performance after receiving feedback and educational module
622878|NCT00465361|P1|Participant Flow|Intervention|Performance after receiving feedback and educational module
622879|NCT00465361|O1|Outcome|Intervention|Performance after receiving feedback and educational module
622880|NCT00465361|E1|Reported Event|Intervention|Performance after receiving feedback and educational module
622881|NCT00465179|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
622882|NCT00465179|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
622883|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
622884|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
622885|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
622886|NCT00465179|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
622887|NCT00465101|B1|Baseline|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
622888|NCT00465101|P1|Participant Flow|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
622889|NCT00465101|O1|Outcome|Retrograde Ejaculation Occurrence Rate|
622890|NCT00465101|O1|Outcome|Total Energy Delivered|
622891|NCT00465101|O1|Outcome|Number of Fibers Used|
622892|NCT00465101|O1|Outcome|Length of Lasing Time|
622893|NCT00465101|O1|Outcome|Length of Procedure (Min)|
622894|NCT00465101|O1|Outcome|Length of Catheterization|
622895|NCT00465101|O1|Outcome|Length of Hospital Stay (Hours)|
622896|NCT00465101|O1|Outcome|Return to Activity (Days)|
622897|NCT00465101|O8|Outcome|5 Years|
622898|NCT00465101|O7|Outcome|4 Years|
622899|NCT00465101|O6|Outcome|3 Year|
622900|NCT00465101|O5|Outcome|2 Years|
622901|NCT00465101|O4|Outcome|1 Year|
622902|NCT00465101|O3|Outcome|6 Months|
622903|NCT00465101|O2|Outcome|3 Months|
622904|NCT00465101|O1|Outcome|Baseline|
622905|NCT00465101|O2|Outcome|Delayed (15-91 Days)|
622906|NCT00465101|O1|Outcome|Peri-Operative (0-14 Days)|
622907|NCT00465101|O8|Outcome|5 Years|
622908|NCT00465101|O7|Outcome|4 Years|
622909|NCT00465101|O6|Outcome|3 Years|
622910|NCT00465101|O5|Outcome|2 Years|
622911|NCT00465101|O4|Outcome|1 Year|
622912|NCT00465101|O3|Outcome|6 Months|
622913|NCT00465101|O2|Outcome|3 Months|
622914|NCT00465101|O1|Outcome|Baseline QoL Score|
622915|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
622916|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
622917|NCT00465101|O1|Outcome|Treatment Related Complication at 3 Months|
622918|NCT00465101|O1|Outcome|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
622919|NCT00465101|E1|Reported Event|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
622920|NCT00465088|B3|Baseline|Total|Total of all reporting groups
622921|NCT00465088|B2|Baseline|Atorvastatin|40 mg atorvastatin once daily at bedtime
622922|NCT00465088|B1|Baseline|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622923|NCT00465088|P2|Participant Flow|Atorvastatin|40 mg atorvastatin once daily at bedtime
622924|NCT00465088|P1|Participant Flow|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622925|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622926|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622927|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622928|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622929|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622930|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622931|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622932|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622933|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
623327|NCT00464334|P1|Participant Flow|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
622934|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622935|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622936|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622937|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622938|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622939|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622940|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622941|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622942|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622943|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622944|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622945|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622946|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622947|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622948|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622949|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622950|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622951|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
622952|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622953|NCT00465088|E2|Reported Event|Atorvastatin|40 mg atorvastatin once daily at bedtime
622954|NCT00465088|E1|Reported Event|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
622955|NCT00464945|B3|Baseline|Total|Total of all reporting groups
622956|NCT00464945|B2|Baseline|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622957|NCT00464945|B1|Baseline|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622958|NCT00464945|P2|Participant Flow|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622959|NCT00464945|P1|Participant Flow|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622960|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
622961|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
622962|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622963|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622964|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622965|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622966|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
623328|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
622967|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622968|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
622969|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
622970|NCT00464945|O8|Outcome|13vPnC Pilot Toddler Dose|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622971|NCT00464945|O7|Outcome|13vPnC Manufacturing Toddler Dose|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622972|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622973|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622974|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622975|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622976|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
622977|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
622978|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622979|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622980|NCT00464945|E6|Reported Event|13vPnC Pilot Toddler Series|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622981|NCT00464945|E5|Reported Event|13vPnC Manufacturing Toddler Series|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
622982|NCT00464945|E4|Reported Event|13vPnC Pilot Post-Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
622983|NCT00464945|E3|Reported Event|13vPnC Manufacturing Post-Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
622984|NCT00464945|E2|Reported Event|13vPnC Pilot Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622985|NCT00464945|E1|Reported Event|13vPnC Manufacturing Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
622986|NCT00464815|B3|Baseline|Total|Total of all reporting groups
642556|NCT00420238|B2|Baseline|Placebo|Subcutaneously (SC), once weekly
622987|NCT00464815|B2|Baseline|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
622988|NCT00464815|B1|Baseline|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
622989|NCT00464815|P2|Participant Flow|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
622990|NCT00464815|P1|Participant Flow|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
622991|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
622992|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
622993|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
622994|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
622995|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
622996|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
622997|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
622998|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
622999|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623000|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623001|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623002|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623003|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623004|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623005|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623006|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623007|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623008|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623009|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623010|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623011|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623012|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623013|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623014|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623015|NCT00464815|O2|Outcome|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623016|NCT00464815|O1|Outcome|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623017|NCT00464815|E2|Reported Event|Mencevax ACWY Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax™ ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
623018|NCT00464815|E1|Reported Event|Nimenrix Group|Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix™ (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
623019|NCT00464737|B4|Baseline|Total|Total of all reporting groups
623020|NCT00464737|B3|Baseline|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623021|NCT00464737|B2|Baseline|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623022|NCT00464737|B1|Baseline|Placebo|Placebo
623023|NCT00464737|P3|Participant Flow|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623024|NCT00464737|P2|Participant Flow|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623025|NCT00464737|P1|Participant Flow|Placebo|Placebo
623026|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623027|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623028|NCT00464737|O1|Outcome|Placebo|Placebo
623029|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623030|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623031|NCT00464737|O1|Outcome|Placebo|Placebo
623032|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623033|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623034|NCT00464737|O1|Outcome|Placebo|Placebo
623035|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623036|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623037|NCT00464737|O1|Outcome|Placebo|Placebo
623038|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623039|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623040|NCT00464737|O1|Outcome|Placebo|Placebo
623041|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623042|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623043|NCT00464737|O1|Outcome|Placebo|Placebo
623044|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623045|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623046|NCT00464737|O1|Outcome|Placebo|Placebo
623047|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623048|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623049|NCT00464737|O1|Outcome|Placebo|Placebo
623050|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623051|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623052|NCT00464737|O1|Outcome|Placebo|Placebo
623053|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623054|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623055|NCT00464737|O1|Outcome|Placebo|Placebo
623056|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623057|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623058|NCT00464737|O1|Outcome|Placebo|Placebo
623059|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623060|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623061|NCT00464737|O1|Outcome|Placebo|Placebo
623062|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623063|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623064|NCT00464737|O1|Outcome|Placebo|Placebo
623065|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623066|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623067|NCT00464737|O1|Outcome|Placebo|Placebo
623068|NCT00464737|E3|Reported Event|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
623069|NCT00464737|E2|Reported Event|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
623070|NCT00464737|E1|Reported Event|Placebo|Placebo
623071|NCT00464711|B1|Baseline|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
623072|NCT00464711|P1|Participant Flow|Escitalopram|40 subjects met inclusion/exclusion criteria and started treatment with escitalopram
623073|NCT00464711|O1|Outcome|Open Label Escitalopram|All subjects were treated with open label escitalopram
623074|NCT00464711|E1|Reported Event|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
623075|NCT00464698|B1|Baseline|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
623076|NCT00464698|P1|Participant Flow|All Study Participants|Duloxetine Week 1 dose: 30mg Duloxetine Weeks 2-4 dose: 60mg Duloxetine Weeks 5-17 dose: 120mg
623077|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
623078|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
623079|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
623080|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
623081|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
623082|NCT00464698|E3|Reported Event|Duloxetine Weeks 5-17 Dose: 120mg|
623083|NCT00464698|E2|Reported Event|Duloxetine Weeks 2-4 Dose: 60mg|
623084|NCT00464698|E1|Reported Event|Duloxetine: Week 1 Dose: 30mg|
623085|NCT00464685|B3|Baseline|Total|Total of all reporting groups
623086|NCT00464685|B2|Baseline|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623087|NCT00464685|B1|Baseline|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623088|NCT00464685|P2|Participant Flow|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623089|NCT00464685|P1|Participant Flow|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623090|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623091|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623092|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623093|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623094|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623095|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623096|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623097|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623098|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623099|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623100|NCT00464685|E2|Reported Event|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623101|NCT00464685|E1|Reported Event|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
623102|NCT00464672|B3|Baseline|Total|Total of all reporting groups
623103|NCT00464672|B2|Baseline|Comparator Influenza Vaccine|Injections of the comparator influenza vaccine were administered intramuscularly
623104|NCT00464672|B1|Baseline|Influenza Virus Vaccine|Injections of the investigational influenza virus vaccine were administered intramuscularly
623105|NCT00464672|P6|Participant Flow|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
623106|NCT00464672|P5|Participant Flow|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623107|NCT00464672|P4|Participant Flow|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
623108|NCT00464672|P3|Participant Flow|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623109|NCT00464672|P2|Participant Flow|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
623110|NCT00464672|P1|Participant Flow|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623111|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
623112|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
623113|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
623114|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623115|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623116|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623117|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (Injection 2)|Injections of the comparator influenza vaccine were administered intramuscularly.
623118|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Injection 2)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
623119|NCT00464672|O2|Outcome|Comparator Influenza Vaccine (Injection 1)|Injections of the comparator influenza vaccine were administered intramuscularly.
623120|NCT00464672|O1|Outcome|Influenza Virus Vaccine (Injection 1)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
623121|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
623122|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
623329|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
623123|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
623124|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623125|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623126|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623127|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
623128|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
623129|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
623130|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623131|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623132|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623133|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
623134|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
623135|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
623136|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623137|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623138|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623139|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|Injection of the comparator influenza vaccine were administered intramuscularly
623140|NCT00464672|O1|Outcome|Influenza Virus Vaccine|Injection of the investigational influenza virus vaccine were administered intramuscularly
623141|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
623142|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
623143|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
623144|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623145|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623146|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623147|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
623148|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
623149|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
623150|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623151|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623152|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623153|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
623154|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
623155|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
623156|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623157|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623158|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623159|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza vaccine was administered intramuscularly
623160|NCT00464672|O1|Outcome|Influenza Virus Vaccine|One injection of the investigational influenza virus vaccine was administered intramuscularly
623161|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
623162|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
623163|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
623164|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623165|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623166|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
643061|NCT00419445|E2|Reported Event|75 mg Tid|
623167|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
623168|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
623169|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
623170|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623171|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623172|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623173|NCT00464672|E6|Reported Event|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
623174|NCT00464672|E5|Reported Event|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
623175|NCT00464672|E4|Reported Event|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
623176|NCT00464672|E3|Reported Event|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623177|NCT00464672|E2|Reported Event|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
623178|NCT00464672|E1|Reported Event|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
623179|NCT00464646|B3|Baseline|Total|Total of all reporting groups
623180|NCT00464646|B2|Baseline|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
623181|NCT00464646|B1|Baseline|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
623182|NCT00464646|P2|Participant Flow|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
623183|NCT00464646|P1|Participant Flow|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
623184|NCT00464646|O2|Outcome|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
623185|NCT00464646|O1|Outcome|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
623186|NCT00464646|E2|Reported Event|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
623187|NCT00464646|E1|Reported Event|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
623188|NCT00464568|B1|Baseline|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
623189|NCT00464568|P1|Participant Flow|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 microgram (mcg) or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
623190|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623191|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623192|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623193|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623194|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623195|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623196|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623197|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623198|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623199|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623200|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623201|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623202|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623203|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623204|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623205|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623206|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623207|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623208|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623209|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623210|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623211|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623212|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623213|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623214|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623215|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623216|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623217|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623218|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623219|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623220|NCT00464568|O4|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623221|NCT00464568|O3|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623222|NCT00464568|O2|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623223|NCT00464568|O1|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623224|NCT00464568|O1|Outcome|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
623225|NCT00464568|O1|Outcome|Overall Study|Eligible participants received unit dose of nasal GSK256066 1 mcg or 10 mcg or 50 mcg or 200 mcg or matching Placebo in any one of the five treatment periods in a randomized manner. Two treatment periods were separated by a 3 day washout period. Participants attended the unit on the morning of dosing and stayed until all study procedures were completed (approximately 4 hours) and were followed-up for maximum of 14 days.
623226|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623227|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623228|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623229|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623230|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623231|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
643062|NCT00419445|E1|Reported Event|25 mg Tid|
623232|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623233|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623234|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623235|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623236|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623237|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623238|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623239|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623240|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623241|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623242|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623243|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623244|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623245|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623246|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623247|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623248|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623249|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623250|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623251|NCT00464568|O5|Outcome|GSK256066 200 mcg|Eligible participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril and were followed-up up to maximum 14 days.
623252|NCT00464568|O4|Outcome|GSK256066 50 mcg|Eligible participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril and were followed-up up to maximum 14 days.
623253|NCT00464568|O3|Outcome|GSK256066 10 mcg|Eligible participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril and were followed-up up to maximum 14 days.
623254|NCT00464568|O2|Outcome|GSK256066 1 mcg|Eligible participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril and were followed-up up to maximum 14 days.
623255|NCT00464568|O1|Outcome|Placebo|Eligible participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril and were followed-up up to maximum 14 days.
623256|NCT00464568|E5|Reported Event|GSK256066 200 mcg|Participants received a single dose of GSK256066 200 mcg aqueous nasal spray via intranasal route, 1 puff of 100 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
623257|NCT00464568|E4|Reported Event|GSK256066 50 mcg|Participants received a single dose of GSK256066 50 mcg aqueous nasal spray via intranasal route, 1 puff of 25 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
623258|NCT00464568|E3|Reported Event|GSK256066 10 mcg|Participants received a single dose of GSK256066 10 mcg aqueous nasal spray via intranasal route, 1 puff of 5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
623259|NCT00464568|E2|Reported Event|GSK256066 1 mcg|Participants received a single dose of GSK256066 1 mcg aqueous nasal spray via intranasal route, 1 puff of 0.5 mcg per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
645773|NCT00412516|B4|Baseline|Total|Total of all reporting groups
623260|NCT00464568|E1|Reported Event|Placebo|Participants received a single dose of aqueous nasal spray of GSK256066 matching placebo via intranasal route, 1 puff per nostril. The total duration of the study per participant was approximately 8 to 9 weeks (up to 4 weeks Screening and 3 weeks dosing (including washout) plus a Follow-up visit at least 7 days (and no more than 14 days) after the last treatment.
623261|NCT00464542|B1|Baseline|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
623262|NCT00464542|P1|Participant Flow|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
623263|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
623264|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
623265|NCT00464542|E1|Reported Event|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
623266|NCT00464490|B3|Baseline|Total|Total of all reporting groups
623267|NCT00464490|B2|Baseline|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
623268|NCT00464490|B1|Baseline|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
623269|NCT00464490|P2|Participant Flow|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
623270|NCT00464490|P1|Participant Flow|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
623271|NCT00464490|O2|Outcome|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
623272|NCT00464490|O1|Outcome|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
623273|NCT00464490|E2|Reported Event|Standard Hospital Protocol (CG)|Control. Hospital weaning per standard protocol
623274|NCT00464490|E1|Reported Event|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
623275|NCT00464464|B3|Baseline|Total|Total of all reporting groups
623276|NCT00464464|B2|Baseline|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
623277|NCT00464464|B1|Baseline|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
623278|NCT00464464|P2|Participant Flow|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
623279|NCT00464464|P1|Participant Flow|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
623280|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
623281|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
623282|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
623283|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
623284|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
623285|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
623286|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
623287|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
623288|NCT00464464|E2|Reported Event|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
623289|NCT00464464|E1|Reported Event|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
623290|NCT00464438|B3|Baseline|Total|Total of all reporting groups
623291|NCT00464438|B2|Baseline|Moxifloxacin 0.5%|
623292|NCT00464438|B1|Baseline|Gatifloxacin 0.3%|
623293|NCT00464438|P2|Participant Flow|Moxifloxacin 0.5%|
623294|NCT00464438|P1|Participant Flow|Gatifloxacin 0.3%|
623295|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
623296|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
623297|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
623298|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
623299|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
623300|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
623301|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
623302|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
623303|NCT00464438|E2|Reported Event|Moxifloxacin 0.5%|
623304|NCT00464438|E1|Reported Event|Gatifloxacin 0.3%|
623305|NCT00464334|B12|Baseline|Total|Total of all reporting groups
623306|NCT00464334|B11|Baseline|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
623307|NCT00464334|B10|Baseline|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
623308|NCT00464334|B9|Baseline|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
623309|NCT00464334|B8|Baseline|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
623310|NCT00464334|B7|Baseline|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
623311|NCT00464334|B6|Baseline|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
623312|NCT00464334|B5|Baseline|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
623313|NCT00464334|B4|Baseline|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
623314|NCT00464334|B3|Baseline|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
623315|NCT00464334|B2|Baseline|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
623316|NCT00464334|B1|Baseline|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
623317|NCT00464334|P11|Participant Flow|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
623318|NCT00464334|P10|Participant Flow|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
623319|NCT00464334|P9|Participant Flow|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
623320|NCT00464334|P8|Participant Flow|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
623321|NCT00464334|P7|Participant Flow|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
623322|NCT00464334|P6|Participant Flow|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
623323|NCT00464334|P5|Participant Flow|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
623324|NCT00464334|P4|Participant Flow|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
623325|NCT00464334|P3|Participant Flow|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
623326|NCT00464334|P2|Participant Flow|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
646255|NCT00410761|B2|Baseline|Placebo|Placebo daily
623330|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
623331|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
623332|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
623333|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
623334|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
623335|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
623336|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
623337|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
623338|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
623339|NCT00464334|O11|Outcome|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
623340|NCT00464334|O10|Outcome|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
623341|NCT00464334|O9|Outcome|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
623342|NCT00464334|O8|Outcome|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
623343|NCT00464334|O7|Outcome|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
623344|NCT00464334|O6|Outcome|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
623345|NCT00464334|O5|Outcome|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
623346|NCT00464334|O4|Outcome|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
623347|NCT00464334|O3|Outcome|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
623348|NCT00464334|O2|Outcome|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
623349|NCT00464334|O1|Outcome|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
623350|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
623351|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
623352|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
623353|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
623354|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
623355|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
623356|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
623357|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
623358|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
623359|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
623360|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
623361|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
623362|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
623363|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
623364|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
623365|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
623366|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
623367|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
623368|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
623369|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
623370|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
623371|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
623372|NCT00464334|E11|Reported Event|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
623373|NCT00464334|E10|Reported Event|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
623374|NCT00464334|E9|Reported Event|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
623375|NCT00464334|E8|Reported Event|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
623376|NCT00464334|E7|Reported Event|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
623377|NCT00464334|E6|Reported Event|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
623378|NCT00464334|E5|Reported Event|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
623379|NCT00464334|E4|Reported Event|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
623380|NCT00464334|E3|Reported Event|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
623381|NCT00464334|E2|Reported Event|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
623382|NCT00464334|E1|Reported Event|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
623383|NCT00464308|B4|Baseline|Total|Total of all reporting groups
623384|NCT00464308|B3|Baseline|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623385|NCT00464308|B2|Baseline|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623386|NCT00464308|B1|Baseline|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623387|NCT00464308|P3|Participant Flow|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623388|NCT00464308|P2|Participant Flow|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623389|NCT00464308|P1|Participant Flow|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623390|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623391|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623392|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623393|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623394|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623395|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623396|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623397|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623398|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623399|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623400|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623401|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623402|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623403|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623404|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623405|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623406|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623407|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623408|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623409|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623410|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623411|NCT00464308|E3|Reported Event|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623412|NCT00464308|E2|Reported Event|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623413|NCT00464308|E1|Reported Event|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
623414|NCT00464269|B5|Baseline|Total Title|
623415|NCT00464269|B4|Baseline|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
623416|NCT00464269|B3|Baseline|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
623417|NCT00464269|B2|Baseline|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
623418|NCT00464269|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
623419|NCT00464269|P4|Participant Flow|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
623420|NCT00464269|P3|Participant Flow|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
623421|NCT00464269|P2|Participant Flow|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
623422|NCT00464269|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
623423|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623424|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623425|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623426|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623523|NCT00464204|P1|Participant Flow|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623524|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623427|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623428|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623429|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623430|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623431|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623432|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623433|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623434|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623435|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623436|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623437|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623438|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623439|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623440|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623441|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623525|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623442|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623443|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623444|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623445|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623446|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623447|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623448|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623449|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623450|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623451|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623452|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623453|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623454|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623455|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623456|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623526|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623457|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623458|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623459|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623460|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623461|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623462|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623463|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623464|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623465|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623466|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623467|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623468|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623469|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623470|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623471|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623527|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623472|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623473|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623474|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623475|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623476|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623477|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623478|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623479|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623480|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623481|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623482|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623483|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623484|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623485|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623486|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623528|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623487|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623488|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623489|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623490|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623491|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623492|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623493|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623494|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623495|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623496|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623497|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623498|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623499|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623500|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623501|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623529|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623502|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623503|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623504|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623505|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623506|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623507|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623508|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623509|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623510|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623511|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623512|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623513|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623514|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
623515|NCT00464269|E4|Reported Event|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
623516|NCT00464269|E3|Reported Event|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
623517|NCT00464269|E2|Reported Event|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
623518|NCT00464269|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
623519|NCT00464204|B3|Baseline|Total|Total of all reporting groups
623520|NCT00464204|B2|Baseline|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623521|NCT00464204|B1|Baseline|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623522|NCT00464204|P2|Participant Flow|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623530|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 % NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623531|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4 Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day.
623532|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623533|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623534|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623535|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623536|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623537|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623538|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623539|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623540|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623541|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623542|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623543|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623544|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623545|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623546|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623547|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623548|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623549|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623550|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623551|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623552|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623553|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623554|NCT00464204|E2|Reported Event|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
623555|NCT00464204|E1|Reported Event|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
623556|NCT00464087|B4|Baseline|Total|Total of all reporting groups
623557|NCT00464087|B3|Baseline|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
623558|NCT00464087|B2|Baseline|Bivalirudin|bivalirudin during angioplasty
623559|NCT00464087|B1|Baseline|Heparin|unfrationated heparin during angioplasty
623560|NCT00464087|P3|Participant Flow|Screen Failures|These patients were enrolled because they received study drug, but did not have enough disease to require PCI.
623561|NCT00464087|P2|Participant Flow|Bivalirudin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI.
623562|NCT00464087|P1|Participant Flow|Heparin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV.
623563|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
623564|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
623565|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
623566|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
623567|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
623568|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
623569|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
623570|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
623571|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
623572|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
623573|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
623574|NCT00464087|E3|Reported Event|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
623575|NCT00464087|E2|Reported Event|Bivalirudin|bivalirudin during angioplasty
623576|NCT00464087|E1|Reported Event|Heparin|unfrationated heparin during angioplasty
623577|NCT00463866|B3|Baseline|Total|Total of all reporting groups
623578|NCT00463866|B2|Baseline|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623579|NCT00463866|B1|Baseline|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623580|NCT00463866|P2|Participant Flow|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623581|NCT00463866|P1|Participant Flow|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623582|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623583|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623584|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623585|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623586|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623587|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623588|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623589|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623590|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623591|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623592|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623593|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623594|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623595|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623596|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623597|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623598|NCT00463866|E2|Reported Event|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
623599|NCT00463866|E1|Reported Event|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
623600|NCT00463840|B1|Baseline|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
623601|NCT00463840|P1|Participant Flow|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
623602|NCT00463840|O1|Outcome|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
623603|NCT00463840|O1|Outcome|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
623715|NCT00463437|P4|Participant Flow|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623604|NCT00463840|E1|Reported Event|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
623605|NCT00463801|B1|Baseline|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
623606|NCT00463801|P1|Participant Flow|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
623607|NCT00463801|O1|Outcome|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
623608|NCT00463801|E1|Reported Event|All Patients|All patients
623609|NCT00463788|B3|Baseline|Total|Total of all reporting groups
623610|NCT00463788|B2|Baseline|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
623611|NCT00463788|B1|Baseline|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
623612|NCT00463788|P2|Participant Flow|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
623613|NCT00463788|P1|Participant Flow|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
623614|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
623615|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
623616|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
623617|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
623618|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
623619|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
623620|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
623621|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
623622|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
623623|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
624058|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
623624|NCT00463788|E3|Reported Event|Cisplatin Alone Switched to Cetuximab|On progression, participants in the cisplatin group had the option to switch to cisplatin (75 mg/m^2 IV infusion) plus cetuximab (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progressive disease was reported during the 6 cisplatin cycles or to cetuximab alone (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progression was reported after the 6 cisplatin cycles.
623625|NCT00463788|E2|Reported Event|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of progressive disease (PD), unacceptable toxicity or withdrawal of consent.
623626|NCT00463788|E1|Reported Event|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly.
623627|NCT00463606|B4|Baseline|Total|Total of all reporting groups
623628|NCT00463606|B3|Baseline|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623629|NCT00463606|B2|Baseline|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
623630|NCT00463606|B1|Baseline|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623631|NCT00463606|P3|Participant Flow|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623632|NCT00463606|P2|Participant Flow|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
623633|NCT00463606|P1|Participant Flow|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623634|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623635|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623636|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623637|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623638|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623639|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623640|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623641|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623642|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623643|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623644|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
623645|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623646|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
623647|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623648|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623649|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623650|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623651|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623652|NCT00463606|E3|Reported Event|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
623653|NCT00463606|E2|Reported Event|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
623654|NCT00463606|E1|Reported Event|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
623655|NCT00463580|B3|Baseline|Total|Total of all reporting groups
623656|NCT00463580|B2|Baseline|Placebo|Placebo (3 infusions of saline)
623657|NCT00463580|B1|Baseline|Infliximab|Infliximab (3 infusions of infliximab - 5mg/kg)
623658|NCT00463580|P2|Participant Flow|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
623659|NCT00463580|P1|Participant Flow|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
623660|NCT00463580|O2|Outcome|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
623661|NCT00463580|O1|Outcome|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
623662|NCT00463580|O2|Outcome|Placebo|Normal Saline
623663|NCT00463580|O1|Outcome|Infliximab|Infliximab
623664|NCT00463580|E2|Reported Event|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
623665|NCT00463580|E1|Reported Event|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
623666|NCT00463567|B8|Baseline|Total|Total of all reporting groups
623667|NCT00463567|B7|Baseline|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
646256|NCT00410761|B1|Baseline|Vandetanib 300 mg|Vandetanib (300 mg daily)
623668|NCT00463567|B6|Baseline|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623669|NCT00463567|B5|Baseline|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623670|NCT00463567|B4|Baseline|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623671|NCT00463567|B3|Baseline|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623672|NCT00463567|B2|Baseline|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623673|NCT00463567|B1|Baseline|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623674|NCT00463567|P7|Participant Flow|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623675|NCT00463567|P6|Participant Flow|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623676|NCT00463567|P5|Participant Flow|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623677|NCT00463567|P4|Participant Flow|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623678|NCT00463567|P3|Participant Flow|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623679|NCT00463567|P2|Participant Flow|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623680|NCT00463567|P1|Participant Flow|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623681|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
624154|NCT00462644|P2|Participant Flow|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
623682|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623683|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623684|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623685|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623686|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623687|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623688|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623689|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623690|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623691|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623692|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623693|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623694|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623695|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623696|NCT00463567|O3|Outcome|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623697|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623698|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623716|NCT00463437|P3|Participant Flow|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623699|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623700|NCT00463567|O3|Outcome|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623701|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623702|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623703|NCT00463567|E7|Reported Event|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623704|NCT00463567|E6|Reported Event|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623705|NCT00463567|E5|Reported Event|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623706|NCT00463567|E4|Reported Event|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623707|NCT00463567|E3|Reported Event|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623708|NCT00463567|E2|Reported Event|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623709|NCT00463567|E1|Reported Event|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
623710|NCT00463437|B5|Baseline|Total|Total of all reporting groups
623711|NCT00463437|B4|Baseline|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623712|NCT00463437|B3|Baseline|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623713|NCT00463437|B2|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623714|NCT00463437|B1|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623717|NCT00463437|P2|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623718|NCT00463437|P1|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623719|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623720|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623721|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623722|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623723|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623724|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623725|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623726|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623727|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623728|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623729|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623730|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623731|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623732|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623733|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623734|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623735|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623736|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623737|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623738|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623739|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623740|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623741|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623742|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623743|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623744|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623745|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623746|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623747|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623748|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623749|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623750|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623751|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623752|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623753|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623754|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623755|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623756|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623757|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623758|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623759|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623760|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623761|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623762|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623763|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623764|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623765|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623766|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623767|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623768|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623769|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623770|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623771|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623772|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623773|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623774|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623775|NCT00463437|E4|Reported Event|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623776|NCT00463437|E3|Reported Event|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
623777|NCT00463437|E2|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
623778|NCT00463437|E1|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
623779|NCT00463385|B5|Baseline|Total|Total of all reporting groups
623780|NCT00463385|B4|Baseline|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623781|NCT00463385|B3|Baseline|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623782|NCT00463385|B2|Baseline|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623783|NCT00463385|B1|Baseline|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623784|NCT00463385|P4|Participant Flow|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623785|NCT00463385|P3|Participant Flow|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623786|NCT00463385|P2|Participant Flow|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623787|NCT00463385|P1|Participant Flow|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623788|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623789|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623790|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
624155|NCT00462644|P1|Participant Flow|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
623791|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623792|NCT00463385|O8|Outcome|Pomalidomide 0.5 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623793|NCT00463385|O7|Outcome|Pomalidomide 2 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623794|NCT00463385|O6|Outcome|Pomalidomide 2 mg, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623795|NCT00463385|O5|Outcome|Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623796|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623797|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623798|NCT00463385|O2|Outcome|Pomalidomide 2 mg, PositiveJAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623799|NCT00463385|O1|Outcome|Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623800|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623801|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623802|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
624156|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
623803|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623804|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623805|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623806|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623807|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623808|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623809|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623810|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623811|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623812|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623813|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623814|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623815|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
624157|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
623816|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623817|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623818|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623819|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623820|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623821|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623822|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623823|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623824|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623825|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623826|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623827|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623828|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623829|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623830|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623831|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623832|NCT00463385|E4|Reported Event|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623833|NCT00463385|E3|Reported Event|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623834|NCT00463385|E2|Reported Event|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
623835|NCT00463385|E1|Reported Event|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
623836|NCT00463346|B3|Baseline|Total|Total of all reporting groups
623837|NCT00463346|B2|Baseline|Placebo|Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623838|NCT00463346|B1|Baseline|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623839|NCT00463346|P2|Participant Flow|Placebo|dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623840|NCT00463346|P1|Participant Flow|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623841|NCT00463346|O2|Outcome|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623842|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate~Acamprosate: Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
623843|NCT00463346|O2|Outcome|Placebo|Placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623844|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate~1998 mg TID Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
623845|NCT00463346|E2|Reported Event|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623846|NCT00463346|E1|Reported Event|Acamprosate|Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
623847|NCT00463229|B3|Baseline|Total|Total of all reporting groups
623848|NCT00463229|B2|Baseline|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
623849|NCT00463229|B1|Baseline|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
623850|NCT00463229|P2|Participant Flow|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
624528|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to trat cohort)
623851|NCT00463229|P1|Participant Flow|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
623852|NCT00463229|O2|Outcome|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
623853|NCT00463229|O1|Outcome|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
623854|NCT00463229|E2|Reported Event|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
623855|NCT00463229|E1|Reported Event|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
623856|NCT00463047|B1|Baseline|Total Number of Patients|Fentanyl Buccal Tablets (FBT) and Immediate-Release Oxycodone crossover. The total number of patients (323) reflect the number that were enrolled to participate in the study prior to the first titration period. Three subjects withdrew before receiving any study drug so they are not listed as being assigned to either dosing arm in the titration studies, leaving only 320 subjects who were evenly divided between the two groups.
623857|NCT00463047|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Patients were randomly assigned 1:1 to either titrate FBT during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
623858|NCT00463047|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Patients were randomized 1:1 to titrate Fentanyl Buccal Tablet (FBT) during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
623859|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623860|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623861|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623862|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623863|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623864|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623865|NCT00463047|O1|Outcome|Total|Includes all patients who participated in the double-blind treatment period and completed treatment.
624158|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
624796|NCT00461175|P1|Participant Flow|LNG IUS|New users of Mirena® IUS
623866|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623867|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623868|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623869|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623870|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623871|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623872|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623873|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623874|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623875|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623876|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623877|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623878|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623879|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623880|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623881|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623882|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623883|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623884|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623885|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623886|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623887|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
624159|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
623888|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623889|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623890|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623891|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623892|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623893|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623894|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623895|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623896|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623897|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623898|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623899|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623900|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623901|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623902|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623903|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623904|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623905|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623906|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623907|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623908|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623909|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
624205|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
623910|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623911|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623912|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623913|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623914|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623915|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623916|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623917|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623918|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623919|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623920|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623921|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623922|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623923|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623924|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623925|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623926|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623927|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623928|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623929|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623930|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623931|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
624376|NCT00462020|B1|Baseline|IV Only|5 days of IV antibiotics after appendectomy
624797|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
623932|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623933|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623934|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623935|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623936|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623937|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623938|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
623939|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
623940|NCT00463047|E2|Reported Event|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug. This arm represents all subjects who had exposure to at least one dose of immediate-release oxycodone either during the titration periods or double-blind periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
623941|NCT00463047|E1|Reported Event|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients. This group includes all subjects in this study who had taken at least one dose of FBT in the course of the study, including both titration periods and both double-blind treatment periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
623942|NCT00462982|B1|Baseline|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
623943|NCT00462982|P1|Participant Flow|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
623944|NCT00462982|O1|Outcome|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
623945|NCT00462982|E1|Reported Event|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
623946|NCT00462943|B4|Baseline|Total|Total of all reporting groups
623947|NCT00462943|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623948|NCT00462943|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623949|NCT00462943|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623950|NCT00462943|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623951|NCT00462943|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623952|NCT00462943|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623953|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623954|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623955|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623956|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623957|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623958|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623959|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623960|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623961|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623962|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623963|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623964|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623965|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624377|NCT00462020|P2|Participant Flow|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
623966|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623967|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623968|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623969|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623970|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623971|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623972|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623973|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623974|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623975|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623976|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623977|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623978|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623979|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624160|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
623980|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623981|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623982|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623983|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623984|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623985|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623986|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623987|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623988|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623989|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623990|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623991|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623992|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623993|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624161|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
623994|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623995|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623996|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623997|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623998|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
623999|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624000|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624001|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624002|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624003|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624004|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624005|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624006|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624007|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624162|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
624008|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624009|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624010|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624011|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624012|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624013|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624014|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624015|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624016|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624017|NCT00462943|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
624018|NCT00462917|B5|Baseline|Total|Total of all reporting groups
624019|NCT00462917|B4|Baseline|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624020|NCT00462917|B3|Baseline|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
624021|NCT00462917|B2|Baseline|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624022|NCT00462917|B1|Baseline|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
624023|NCT00462917|P4|Participant Flow|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624024|NCT00462917|P3|Participant Flow|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
624025|NCT00462917|P2|Participant Flow|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624026|NCT00462917|P1|Participant Flow|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
624027|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624028|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
624029|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624030|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
624031|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624032|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
624033|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624034|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
624035|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624036|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
624037|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624038|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
624039|NCT00462917|E4|Reported Event|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624798|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
624040|NCT00462917|E3|Reported Event|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
624041|NCT00462917|E2|Reported Event|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
624042|NCT00462917|E1|Reported Event|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
624043|NCT00462865|B1|Baseline|Treatment|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
624044|NCT00462865|P1|Participant Flow|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
624045|NCT00462865|O1|Outcome|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
624046|NCT00462865|E1|Reported Event|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
624047|NCT00462839|B3|Baseline|Total|Total of all reporting groups
624048|NCT00462839|B2|Baseline|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624049|NCT00462839|B1|Baseline|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624050|NCT00462839|P2|Participant Flow|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624051|NCT00462839|P1|Participant Flow|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624052|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624053|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624054|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624055|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624056|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624057|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624163|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
624378|NCT00462020|P1|Participant Flow|IV Only|5 days of IV antibiotics after appendectomy
624059|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624060|NCT00462839|E2|Reported Event|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624061|NCT00462839|E1|Reported Event|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
624062|NCT00462826|B1|Baseline|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
624063|NCT00462826|P1|Participant Flow|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
624064|NCT00462826|O1|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
624065|NCT00462826|O1|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
624066|NCT00462826|O6|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
624067|NCT00462826|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
624068|NCT00462826|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
624069|NCT00462826|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
624070|NCT00462826|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
624071|NCT00462826|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
624072|NCT00462826|O1|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
624073|NCT00462826|O1|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
624074|NCT00462826|E1|Reported Event|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
624075|NCT00462748|B4|Baseline|Total|Total of all reporting groups
624076|NCT00462748|B3|Baseline|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
624077|NCT00462748|B2|Baseline|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
624078|NCT00462748|B1|Baseline|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
624079|NCT00462748|P3|Participant Flow|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
624080|NCT00462748|P2|Participant Flow|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
624081|NCT00462748|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
624082|NCT00462748|O3|Outcome|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
624083|NCT00462748|O2|Outcome|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
624084|NCT00462748|O1|Outcome|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
624085|NCT00462748|E3|Reported Event|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
624086|NCT00462748|E2|Reported Event|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
624087|NCT00462748|E1|Reported Event|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
624088|NCT00462735|B1|Baseline|Advanced Head and Neck Cancer|Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
624089|NCT00462735|P1|Participant Flow|Advanced Head and Neck Cancer|"Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck. Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.~Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.~Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients."
624090|NCT00462735|O1|Outcome|Advanced Head and Neck Cancer|Cetuximab - 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
624091|NCT00462735|O1|Outcome|Advanced Head and Neck Cancer|Cetuximab - 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
624379|NCT00462020|O2|Outcome|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
624092|NCT00462735|O1|Outcome|Advanced Head and Neck Cancer|Cetuximab - 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
624093|NCT00462735|O1|Outcome|Advanced Head and Neck Cancer|Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
624094|NCT00462735|O1|Outcome|Advanced Head and Neck Cancer|Cetuximab- 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients. Hydroxyurea - 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation. Fluorouracil - continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours. Radiotherapy.
624095|NCT00462735|E1|Reported Event|Advanced Head and Neck Cancer|Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
624096|NCT00462722|B4|Baseline|Total|Total of all reporting groups
624097|NCT00462722|B3|Baseline|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624098|NCT00462722|B2|Baseline|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624099|NCT00462722|B1|Baseline|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624100|NCT00462722|P3|Participant Flow|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624101|NCT00462722|P2|Participant Flow|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624102|NCT00462722|P1|Participant Flow|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624103|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624104|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624105|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624106|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624107|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624108|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624164|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
624109|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624110|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624111|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624112|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624113|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624114|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624115|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624116|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624117|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624118|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624119|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624120|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624121|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624122|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624123|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624380|NCT00462020|O1|Outcome|IV Only|5 days of IV antibiotics after appendectomy
624124|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624125|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624126|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624127|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624128|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624129|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624130|NCT00462722|E3|Reported Event|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624131|NCT00462722|E2|Reported Event|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624132|NCT00462722|E1|Reported Event|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
624133|NCT00462709|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
624134|NCT00462709|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV) every 3 to 7 days.
624135|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
624136|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
624137|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
624138|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
624139|NCT00462709|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
624140|NCT00462670|B3|Baseline|Total|Total of all reporting groups
624141|NCT00462670|B2|Baseline|OPC-41061|15mg of OPC-41061 per day for 7days p.o. administration
624142|NCT00462670|B1|Baseline|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
624143|NCT00462670|P2|Participant Flow|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
624144|NCT00462670|P1|Participant Flow|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
624145|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
624146|NCT00462670|O1|Outcome|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
624147|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
624148|NCT00462670|O1|Outcome|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
624149|NCT00462670|E2|Reported Event|OPC-41061 15mg|15 mg of OPC-41061 per day for 7days p.o. administration
624150|NCT00462670|E1|Reported Event|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
624151|NCT00462644|B3|Baseline|Total|Total of all reporting groups
624152|NCT00462644|B2|Baseline|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
624153|NCT00462644|B1|Baseline|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
624165|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
624166|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
624167|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
624168|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
624169|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
624170|NCT00462644|E2|Reported Event|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
624171|NCT00462644|E1|Reported Event|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
624172|NCT00462605|B1|Baseline|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624173|NCT00462605|P1|Participant Flow|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624174|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624175|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624176|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624177|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624178|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624179|NCT00462605|E1|Reported Event|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
624203|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
624204|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
624799|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
624180|NCT00462501|B1|Baseline|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
624181|NCT00462501|P1|Participant Flow|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
624182|NCT00462501|O1|Outcome|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
624183|NCT00462501|E1|Reported Event|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
624184|NCT00462462|B3|Baseline|Total|Total of all reporting groups
624185|NCT00462462|B2|Baseline|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
624186|NCT00462462|B1|Baseline|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
624187|NCT00462462|P2|Participant Flow|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
624188|NCT00462462|P1|Participant Flow|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
624189|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and for whom lesional volume measurements were available at screening and at study end
624190|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and for whom lesional volume measurements were available at screening and at study end
624191|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and who had blood samples just before and during infusion procedure (one patient who received Absolute Ethanol was not sampled during infusion procedure).
624192|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and who had blood samples just before and during infusion procedure.
624193|NCT00462462|E2|Reported Event|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
624194|NCT00462462|E1|Reported Event|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
624195|NCT00462449|B3|Baseline|Total|Total of all reporting groups
624196|NCT00462449|B2|Baseline|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
624197|NCT00462449|B1|Baseline|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
624198|NCT00462449|P2|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
624199|NCT00462449|P1|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
624200|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
624201|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
624202|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
624800|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
624206|NCT00462449|E2|Reported Event|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
624207|NCT00462449|E1|Reported Event|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
624208|NCT00462423|B1|Baseline|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
624209|NCT00462423|P1|Participant Flow|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
624210|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).~Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
624211|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
624212|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).~Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
624213|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
624214|NCT00462423|E1|Reported Event|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
624215|NCT00462384|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624216|NCT00462384|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624217|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624218|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624219|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624220|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624221|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624222|NCT00462384|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
624223|NCT00462345|B1|Baseline|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624224|NCT00462345|P1|Participant Flow|Rituximab, Methotrexate|Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624225|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624381|NCT00462020|E2|Reported Event|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
624382|NCT00462020|E1|Reported Event|IV Only|5 days of IV antibiotics after appendectomy
624226|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624227|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624228|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624229|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624230|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624231|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624232|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624233|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624234|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624235|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624236|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624237|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624383|NCT00461981|B3|Baseline|Total|Total of all reporting groups
624238|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624239|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624240|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624241|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624242|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624243|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624244|NCT00462345|E1|Reported Event|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
624245|NCT00462332|B3|Baseline|Total|Total of all reporting groups
624246|NCT00462332|B2|Baseline|Low Risk Patients|Category of risk will be defined according to biological features.
624247|NCT00462332|B1|Baseline|High Risk Patientes|Category of risk will be defined according to biological features.
624248|NCT00462332|P2|Participant Flow|Low Risk Patients|Category of risk will be defined according to biological features.
624249|NCT00462332|P1|Participant Flow|High Risk Patientes|Category of risk will be defined according to biological features.
624250|NCT00462332|O2|Outcome|Low Risk Patients|Category of risk will be defined according to biological features.
624251|NCT00462332|O1|Outcome|High Risk Patientes|Category of risk will be defined according to biological features.
624252|NCT00462332|O2|Outcome|High Risk Patients|
624253|NCT00462332|O1|Outcome|Low Risk Patients|
624254|NCT00462332|E2|Reported Event|Low Risk Patients|Category of risk will be defined according to biological features.
624255|NCT00462332|E1|Reported Event|High Risk Patientes|Category of risk will be defined according to biological features.
624256|NCT00462306|B3|Baseline|Total|Total of all reporting groups
624257|NCT00462306|B2|Baseline|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
624258|NCT00462306|B1|Baseline|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
624259|NCT00462306|P2|Participant Flow|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
624260|NCT00462306|P1|Participant Flow|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
624261|NCT00462306|O2|Outcome|Negative Berlin Questionnaires|Pregnant Women with Results of Berlin Questionnaire not Indicative of Sleep Disordered Breathing
624262|NCT00462306|O1|Outcome|Positive Berlin Questionaires|Pregnant Women with Berlin Questionnaire Responses Indicative of Sleep Disordered Breathing
624263|NCT00462306|O2|Outcome|Non-Pregnant Women|Non-pregnant women undergoing a surgical procedure
624264|NCT00462306|O1|Outcome|Pregnant Women|
624265|NCT00462306|E2|Reported Event|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
624801|NCT00461175|E2|Reported Event|Copper IUD|New users of Copper IUD
624266|NCT00462306|E1|Reported Event|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
624267|NCT00462280|B5|Baseline|Total|Total of all reporting groups
624268|NCT00462280|B4|Baseline|One Large Nevi Group-Placebo|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624269|NCT00462280|B3|Baseline|One Large Nevi Group-Lovastatin|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624270|NCT00462280|B2|Baseline|Two Matched Nevi Group-Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624271|NCT00462280|B1|Baseline|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624272|NCT00462280|P4|Participant Flow|One Large Nevi Group - Placebo|"Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624273|NCT00462280|P3|Participant Flow|One Large Nevi Group - Lovastatin|"Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624274|NCT00462280|P2|Participant Flow|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624275|NCT00462280|P1|Participant Flow|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624276|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624277|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624278|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624279|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624280|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624281|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624282|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624283|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624284|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624285|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624286|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624287|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624384|NCT00461981|B2|Baseline|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624288|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624289|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624290|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624291|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624292|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624293|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624294|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624295|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624296|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624297|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624298|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624299|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624300|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624301|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624302|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624303|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624304|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624305|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624306|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624307|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624385|NCT00461981|B1|Baseline|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624308|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624309|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624310|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624311|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624312|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624313|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624314|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624315|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624316|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624317|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624318|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624319|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624320|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624321|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624322|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624323|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624324|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624325|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm.~Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624326|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624327|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624328|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624329|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624330|NCT00462280|E4|Reported Event|One Large Nevi Group-Placebo|Patients who have one large nevi receive placebo PO QD for up to 6 months
624331|NCT00462280|E3|Reported Event|One Large Nevi Group-Lovastatin|Patients who have one large nevi received lovastatin PO QD for up to 6 months
624332|NCT00462280|E2|Reported Event|Two Matched Nevi Group-Placebo|"Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624333|NCT00462280|E1|Reported Event|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
624334|NCT00462228|B1|Baseline|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design.
624335|NCT00462228|P1|Participant Flow|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design. Five subjects were randomized to begin the study by taking memantine and crossover to placebo; seven subjects began with placebo and crossed over to memantine.
624336|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624337|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624338|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624339|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624340|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624341|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624342|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624343|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624344|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624345|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624346|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624347|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624348|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624349|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624350|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
624351|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
624352|NCT00462228|E3|Reported Event|No Treatment (Washout)|All 11 subjects completed a 4 week washout between memantine and placebo arms and a 4 week washout at the end of the study.
624353|NCT00462228|E2|Reported Event|Memantine|All 11 subjects completed 12 weeks of memantine treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
624354|NCT00462228|E1|Reported Event|Placebo|All 11 subjects completed 12 weeks of placebo treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
624355|NCT00462072|B4|Baseline|Total|Total of all reporting groups
624356|NCT00462072|B3|Baseline|Psoriasis (Ps)|Ps subjects starting Infliximab
624357|NCT00462072|B2|Baseline|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab
624358|NCT00462072|B1|Baseline|Rheumatoid Arthritis (RA)|RA subject starting Infliximab
624359|NCT00462072|P3|Participant Flow|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
624360|NCT00462072|P2|Participant Flow|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
624361|NCT00462072|P1|Participant Flow|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
624362|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
624363|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
624364|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
624365|NCT00462072|O2|Outcome|Rheumatoid Arthritis|RA subjects taking Infliximab as part of their standard of care.
624366|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
624367|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
624368|NCT00462072|O1|Outcome|Psoriariatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
624369|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects starting Infliximab as part of their standard of care.
624370|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab as part of their standard of care.
624371|NCT00462072|E3|Reported Event|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
624372|NCT00462072|E2|Reported Event|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
624373|NCT00462072|E1|Reported Event|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
624374|NCT00462020|B3|Baseline|Total|Total of all reporting groups
624375|NCT00462020|B2|Baseline|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
624386|NCT00461981|P2|Participant Flow|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624387|NCT00461981|P1|Participant Flow|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624388|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624389|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624390|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624391|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624392|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624393|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624394|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624395|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624396|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624397|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624398|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624399|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624400|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624401|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624402|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624403|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624404|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624405|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624406|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624407|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624408|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624409|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624410|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624411|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624412|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624413|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624414|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624415|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624416|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624417|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624418|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624419|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624420|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624421|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624422|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624423|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624424|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624425|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624426|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624427|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624428|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624429|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624430|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624431|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624432|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624433|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624434|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624435|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624436|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624437|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624438|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624439|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624440|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624441|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624442|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624443|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624444|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624445|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624446|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624447|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624448|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624449|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624450|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624451|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624452|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624453|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624454|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624455|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624456|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624457|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624458|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624459|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624460|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624461|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624462|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624463|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624464|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624465|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624466|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624467|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624468|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624469|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624470|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624471|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624472|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624473|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624474|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624475|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624476|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624477|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624478|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624479|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624480|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624481|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624482|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624483|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624484|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624485|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624486|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624487|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624488|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624489|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624490|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624491|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624492|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624493|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624494|NCT00461981|E2|Reported Event|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
624495|NCT00461981|E1|Reported Event|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
624496|NCT00461851|B1|Baseline|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
624497|NCT00461851|P1|Participant Flow|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
624498|NCT00461851|O1|Outcome|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
624499|NCT00461851|O1|Outcome|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
624500|NCT00461851|O1|Outcome|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
624501|NCT00461851|E1|Reported Event|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
624502|NCT00461812|B1|Baseline|All Participants|"Mometasone~or~Advair"
624503|NCT00461812|P1|Participant Flow|All Participants|"Mometasone~or~Advair"
624504|NCT00461812|O2|Outcome|Advair|Advair
624505|NCT00461812|O1|Outcome|Mometasone|Mometasone
624506|NCT00461812|E1|Reported Event|All Participants|"Mometasone~or~Advair~Adverse event data and the number of participants assigned to each Arm/Group is unknown because the PI left the institution and this information is unavailable"
624507|NCT00461786|B1|Baseline|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624508|NCT00461786|P1|Participant Flow|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624509|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624510|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624511|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624512|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624513|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624514|NCT00461786|E1|Reported Event|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
624515|NCT00461734|B3|Baseline|Total|Total of all reporting groups
624516|NCT00461734|B2|Baseline|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
624517|NCT00461734|B1|Baseline|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
624518|NCT00461734|P2|Participant Flow|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
624519|NCT00461734|P1|Participant Flow|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
624520|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
624521|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
624522|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
624523|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
624524|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
624525|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
624526|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
624527|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
624802|NCT00461175|E1|Reported Event|LNG IUS|New users of Mirena® IUS
624529|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
624530|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
624531|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
624532|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
624533|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
624534|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
624535|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
624536|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
624537|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
624538|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
624539|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
624540|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
624541|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
624542|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
624543|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
624544|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
624545|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
624546|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
624547|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
624548|NCT00461734|E2|Reported Event|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
624549|NCT00461734|E1|Reported Event|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
624550|NCT00461708|B3|Baseline|Total|Total of all reporting groups
624551|NCT00461708|B2|Baseline|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624552|NCT00461708|B1|Baseline|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624553|NCT00461708|P2|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624554|NCT00461708|P1|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2|Participants with a rash Grade < 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (V) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624555|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624556|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624557|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624803|NCT00461123|B3|Baseline|Total|Total of all reporting groups
624558|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624559|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624560|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624561|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624562|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624563|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624564|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624565|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624566|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624567|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624568|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624569|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624570|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624882|NCT00460811|P2|Participant Flow|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
646257|NCT00410761|P2|Participant Flow|Placebo|Placebo daily
624571|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624572|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624573|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624574|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624575|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624576|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624577|NCT00461708|E2|Reported Event|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624578|NCT00461708|E1|Reported Event|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
624579|NCT00461682|B1|Baseline|Overall Study Arm|
624580|NCT00461682|P1|Participant Flow|Total Population|Eligible participants were planned to receive oral SB-705498 eight hundred (800) milligrams (mg) once daily or matching Placebo in a randomized manner over two treatment periods once in the study. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624581|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624582|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624583|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624584|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624585|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624586|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624587|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624588|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624589|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
646260|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
624590|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624591|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624592|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624593|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624594|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624595|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624596|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624597|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624598|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624599|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624600|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624601|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624602|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624603|NCT00461682|E2|Reported Event|SB-705498|Participants were planned to receive oral SB-705498 800 milligrams (mg) once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
624604|NCT00461682|E1|Reported Event|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
624605|NCT00461630|B3|Baseline|Total|Total of all reporting groups
624606|NCT00461630|B2|Baseline|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624607|NCT00461630|B1|Baseline|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624608|NCT00461630|P2|Participant Flow|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624609|NCT00461630|P1|Participant Flow|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624610|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624611|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624612|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624613|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624614|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624615|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624616|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624617|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624618|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624883|NCT00460811|P1|Participant Flow|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624619|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624620|NCT00461630|E2|Reported Event|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624621|NCT00461630|E1|Reported Event|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
624622|NCT00461591|B3|Baseline|Total|Total of all reporting groups
624623|NCT00461591|B2|Baseline|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624624|NCT00461591|B1|Baseline|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624625|NCT00461591|P2|Participant Flow|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624626|NCT00461591|P1|Participant Flow|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624627|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624628|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624629|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624630|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624631|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624632|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624633|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624634|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624635|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624636|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624637|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624638|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624639|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624640|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624641|NCT00461591|O2|Outcome|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624642|NCT00461591|O1|Outcome|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624643|NCT00461591|E2|Reported Event|Placebo|Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
624644|NCT00461591|E1|Reported Event|Apaziquone|Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
624645|NCT00461513|B3|Baseline|Total|Total of all reporting groups
624646|NCT00461513|B2|Baseline|Usual Care Group|Baseline characteristics of patients who enrolled and were randomized to the Usual Care Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months).Therefore the total number completed in the Usual Care Arm was 172, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 197 patients.
624647|NCT00461513|B1|Baseline|Intervention Group|Baseline characteristics of patients who enrolled and were randomized to the Intervention Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months). Therefore the total number completed in the Intervention Arm was 165, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 187 patients.
624648|NCT00461513|P2|Participant Flow|Usual Care|Patients randomized to the usual care arm continued to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group were given information sheets that outlined self-care for CHF, and provided with a scale if needed at the enrollment visit. Patients in the usual care group had the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients were notified of the results of all screening studies (patient survey results, lab tests).
624649|NCT00461513|P1|Participant Flow|Intervention|The PCDM intervention included evaluation of CHF care by the collaborative care (CC) team with treatment recommendations based on current ACC/AHA clinical practice guidelines, telemonitoring, and screening and treatment for comorbid depression. The CC team at each site included a primary care provider, cardiologist and psychiatrist, as well as nurse and pharmacist. For each intervention patient, there was initial assessment of care following the enrollment visit. Each intervention patient was re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients had daily telemonitoring, and their care was reviewed if the telemonitoring data suggested clinical deterioration.
624650|NCT00461513|O2|Outcome|Usual Care|
624651|NCT00461513|O1|Outcome|Intervention|
624652|NCT00461513|E2|Reported Event|Usual Care|
624653|NCT00461513|E1|Reported Event|Intervention|
624654|NCT00461500|B3|Baseline|Total|Total of all reporting groups
624655|NCT00461500|B2|Baseline|FP 100: Fluticasone Propionate.|Analysis population used in this arm is ITT population(Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
624884|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
624656|NCT00461500|B1|Baseline|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|Analysis population used in this arm is ITT (intent-to-treat) population (Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
624657|NCT00461500|P2|Participant Flow|FP (Fluticasone Propionate)100|Analysis population are all randomized subjects in this arm. 100ug - one inhalation twice daily
624658|NCT00461500|P1|Participant Flow|SFC (Salmeterol Xinafoate/Fluticasone Propionate Combination)|Analysis population are all randomized subjects in this arm. 50/100ug - one inhalation twice daily
624659|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624660|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624661|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624662|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624663|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624664|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624665|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624666|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624667|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624668|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624669|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624670|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624671|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624672|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624673|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624674|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624675|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624676|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624677|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624678|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624679|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624680|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624681|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624682|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624683|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624684|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624685|NCT00461500|E2|Reported Event|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
624686|NCT00461500|E1|Reported Event|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
624687|NCT00461331|B1|Baseline|Entire Study Population|These are the characteristics of the entire study population.
624688|NCT00461331|P2|Participant Flow|Lispro First, Washout, Then Aspart|Patients used Lispro Insulin for up to 100 hours, then entered a two week wash out period, then used Aspart insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
624689|NCT00461331|P1|Participant Flow|Aspart First, Washout, Then Lispro|Patients used Aspart Insulin for up to 100 hours, then entered a two week wash out period, then used Lispro insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
624690|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
624691|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
624692|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
624693|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
624694|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
624695|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
624696|NCT00461331|E2|Reported Event|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
624697|NCT00461331|E1|Reported Event|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
624698|NCT00461305|B3|Baseline|Total|Total of all reporting groups
624699|NCT00461305|B2|Baseline|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624700|NCT00461305|B1|Baseline|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624701|NCT00461305|P2|Participant Flow|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624702|NCT00461305|P1|Participant Flow|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624703|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624704|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624705|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624706|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624707|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624708|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624709|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624710|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624711|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624712|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624713|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624714|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624715|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624716|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624717|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624885|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624718|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624719|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624720|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624721|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624722|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624723|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624724|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624725|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624726|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624727|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624728|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624729|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624730|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624731|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624732|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624733|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624734|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624735|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624736|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624737|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624738|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624739|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624740|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624741|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624742|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624743|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624744|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624745|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624746|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624886|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624747|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624748|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624749|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624750|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624751|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624752|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624753|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624754|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624755|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624756|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624757|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624758|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624759|NCT00461305|E2|Reported Event|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
624760|NCT00461305|E1|Reported Event|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
624761|NCT00461292|B4|Baseline|Total|Total of all reporting groups
624762|NCT00461292|B3|Baseline|Placebo|Normal saline (placebo)
624763|NCT00461292|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
624764|NCT00461292|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
624765|NCT00461292|P3|Participant Flow|Placebo|Normal saline (placebo)
624766|NCT00461292|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
624767|NCT00461292|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
624768|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
624769|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
624770|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
624771|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
624772|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
624773|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
624774|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
624775|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
624776|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
624777|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
624778|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
624779|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
624780|NCT00461292|E3|Reported Event|Placebo|Normal saline (placebo)
624781|NCT00461292|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
624782|NCT00461292|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
624783|NCT00461253|B3|Baseline|Total|Total of all reporting groups
624784|NCT00461253|B2|Baseline|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
624785|NCT00461253|B1|Baseline|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
624786|NCT00461253|P2|Participant Flow|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
624787|NCT00461253|P1|Participant Flow|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
624788|NCT00461253|O2|Outcome|Cu-IUD|Women who currently or ever used a copper IUDs at time of breast cancer diagnosis
624789|NCT00461253|O1|Outcome|LNG IUD|Women who currently or ever used a LNG IUDs (Mirena) at time of breast cancer diagnosis
624790|NCT00461253|E2|Reported Event|Cu-IUD|Users of copper IUDs
624791|NCT00461253|E1|Reported Event|LNG IUD|Users of LNG IUDs (Mirena)
624792|NCT00461175|B3|Baseline|Total|Total of all reporting groups
624793|NCT00461175|B2|Baseline|Copper IUD|New users of Copper IUD
624794|NCT00461175|B1|Baseline|LNG IUS|New users of Mirena® IUS
624795|NCT00461175|P2|Participant Flow|Copper IUD|New users of Copper IUD
624804|NCT00461123|B2|Baseline|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624805|NCT00461123|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624806|NCT00461123|P2|Participant Flow|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624807|NCT00461123|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624808|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624809|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624810|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624811|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624812|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624813|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624814|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624815|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624816|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624817|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624818|NCT00461123|E2|Reported Event|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
624819|NCT00461123|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
624820|NCT00461097|B3|Baseline|Total|Total of all reporting groups
624821|NCT00461097|B2|Baseline|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624822|NCT00461097|B1|Baseline|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624823|NCT00461097|P2|Participant Flow|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624824|NCT00461097|P1|Participant Flow|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624825|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624826|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624827|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624828|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624829|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624830|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624887|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624888|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624889|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
624890|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624891|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624831|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624832|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624833|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624834|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624835|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624836|NCT00461097|E3|Reported Event|Egg Oral Immunotherapy (OIT), 2-4 Years|"Subjects who failed the 1st or 2nd 10 gm OFC at month 22 or year 2 continue on their egg OIT maintenance dose of 2 gm/day of egg white solid (EWS) or are allowed to attempt escalation up to 2 gm/day for the remainder of the study. Subjects who are not considered tolerant may have a 10 gm OFC at year 3 and year 4 to assess desensitization. Subjects who pass the 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.~Note: The total number of subjects assessed for non-systematic adverse events was 36 (subjects with post 2-year follow-up) and for systematic adverse events was 22 (subjects with post 2-year dosing)."
624837|NCT00461097|E2|Reported Event|Placebo, 0-2 Years|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
624892|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624893|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624894|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
624895|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624896|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624897|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624838|NCT00461097|E1|Reported Event|Egg Oral Immunotherapy (OIT), 0-2 Years|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day. A 10 gm OFC to identify desensitized [1] subjects occurs at month 22. Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC at year 2. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
624839|NCT00461045|B1|Baseline|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624840|NCT00461045|P1|Participant Flow|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624841|NCT00461045|O1|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624842|NCT00461045|O1|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624843|NCT00461045|O1|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624844|NCT00461045|O1|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624845|NCT00461045|O1|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624846|NCT00461045|O1|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624847|NCT00461045|O1|Outcome|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624848|NCT00461045|E1|Reported Event|MRZ 0.5 mg/m^2|Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
624849|NCT00461032|B3|Baseline|Total|Total of all reporting groups
624850|NCT00461032|B2|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
624851|NCT00461032|B1|Baseline|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
624852|NCT00461032|P2|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
624853|NCT00461032|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
624854|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
624855|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
624856|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
624857|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
624858|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
624859|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
624860|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
624861|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
624862|NCT00461032|E2|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
624863|NCT00461032|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
624864|NCT00460993|B3|Baseline|Total|Total of all reporting groups
624865|NCT00460993|B2|Baseline|Group 2|"Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.~Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve."
624866|NCT00460993|B1|Baseline|Group 1|Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.
624867|NCT00460993|P2|Participant Flow|Group 2|Placebo during phase 1, then active drug phase 2. One placebo for 6 days
624868|NCT00460993|P1|Participant Flow|Group 1|Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration.
624869|NCT00460993|O2|Outcome|Group 2|Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days
624870|NCT00460993|O1|Outcome|Group 1|Active drug given in phase 1, then Placebo pill in phase 2. Lunesta Active drug (eszopiclone) 1 mg during three days of active drug. If sleep efficiency does not improve doses increases to 2 mg for the next three days of active drug administration.
624871|NCT00460993|E2|Reported Event|Group 2|Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.
624872|NCT00460993|E1|Reported Event|Group 1|Active drug given in phase 1, then placebo pill given in phase 2.
624873|NCT00460811|B6|Baseline|Total|Total of all reporting groups
624874|NCT00460811|B5|Baseline|Matching Placebo|Dose-matched placebo, oral administration, once per day
624875|NCT00460811|B4|Baseline|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624876|NCT00460811|B3|Baseline|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624877|NCT00460811|B2|Baseline|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624878|NCT00460811|B1|Baseline|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624879|NCT00460811|P5|Participant Flow|Matching Placebo|Dose-matched placebo, oral administration, once per day
624880|NCT00460811|P4|Participant Flow|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624881|NCT00460811|P3|Participant Flow|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624898|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624899|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
624900|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624901|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624902|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624903|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624904|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
624905|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624906|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624907|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624908|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624909|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
624910|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624911|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624912|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624913|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624914|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
624915|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624916|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624917|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624918|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624919|NCT00460811|E5|Reported Event|Matching Placebo|Dose-matched placebo, oral administration, once per day
624920|NCT00460811|E4|Reported Event|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
624921|NCT00460811|E3|Reported Event|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
624922|NCT00460811|E2|Reported Event|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
624923|NCT00460811|E1|Reported Event|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
624924|NCT00460798|B1|Baseline|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624925|NCT00460798|P1|Participant Flow|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624926|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624927|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624928|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624929|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624930|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624931|NCT00460798|E1|Reported Event|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
624932|NCT00460746|B1|Baseline|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624933|NCT00460746|P1|Participant Flow|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
625981|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
624934|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624935|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624936|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624937|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624938|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624939|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624940|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624941|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624942|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624943|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624944|NCT00460746|E1|Reported Event|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
624945|NCT00460655|B3|Baseline|Total|Total of all reporting groups
624946|NCT00460655|B2|Baseline|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624947|NCT00460655|B1|Baseline|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624948|NCT00460655|P4|Participant Flow|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624949|NCT00460655|P3|Participant Flow|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624950|NCT00460655|P2|Participant Flow|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624951|NCT00460655|P1|Participant Flow|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624952|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624953|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624954|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624955|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
625125|NCT00460564|P2|Participant Flow|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625982|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
624956|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624957|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624958|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624959|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624960|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624961|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624962|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624963|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624964|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624965|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624966|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624967|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624968|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624969|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624970|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624971|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624972|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624973|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624974|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624975|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624976|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624977|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624978|NCT00460655|E4|Reported Event|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624979|NCT00460655|E3|Reported Event|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
624980|NCT00460655|E2|Reported Event|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624981|NCT00460655|E1|Reported Event|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
624982|NCT00460603|B13|Baseline|Total|Total of all reporting groups
625126|NCT00460564|P1|Participant Flow|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625983|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
624983|NCT00460603|B12|Baseline|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624984|NCT00460603|B11|Baseline|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624985|NCT00460603|B10|Baseline|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624986|NCT00460603|B9|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624987|NCT00460603|B8|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624988|NCT00460603|B7|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624989|NCT00460603|B6|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624990|NCT00460603|B5|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624991|NCT00460603|B4|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624992|NCT00460603|B3|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624993|NCT00460603|B2|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624994|NCT00460603|B1|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624995|NCT00460603|P12|Participant Flow|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624996|NCT00460603|P11|Participant Flow|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624997|NCT00460603|P10|Participant Flow|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624998|NCT00460603|P9|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
624999|NCT00460603|P8|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625000|NCT00460603|P7|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625001|NCT00460603|P6|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625127|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
646261|NCT00410761|O2|Outcome|Placebo|Placebo daily
625002|NCT00460603|P5|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625003|NCT00460603|P4|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625004|NCT00460603|P3|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625005|NCT00460603|P2|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625006|NCT00460603|P1|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 milligram per square meter (mg/m^2) intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-fluorouracil (5-FU) 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625007|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625008|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625009|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625010|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625174|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625259|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
646262|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
625011|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625012|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625013|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625014|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625015|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625016|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625017|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625018|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625019|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625020|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625175|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625260|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625261|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625021|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625022|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625023|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625024|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625025|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625026|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625027|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625028|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625029|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625262|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625263|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625030|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625031|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625032|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625033|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625034|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625035|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625036|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625037|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625038|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625084|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625039|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625040|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625041|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625042|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625043|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625044|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625045|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625046|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625047|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625121|NCT00460564|P6|Participant Flow|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625048|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625049|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625050|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625051|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625052|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625053|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625054|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625055|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625056|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625176|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625264|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625057|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625058|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625059|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625060|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625061|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625062|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625063|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625064|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625065|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625177|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625265|NCT00460525|E2|Reported Event|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625066|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625067|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625068|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625069|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625070|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625071|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625072|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625073|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625074|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625178|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625179|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625075|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625076|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625077|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625078|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625079|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625080|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625081|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625082|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625083|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625122|NCT00460564|P5|Participant Flow|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625085|NCT00460603|E12|Reported Event|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625086|NCT00460603|E11|Reported Event|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625087|NCT00460603|E10|Reported Event|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625088|NCT00460603|E9|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625089|NCT00460603|E8|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625090|NCT00460603|E7|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625091|NCT00460603|E6|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625092|NCT00460603|E5|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625093|NCT00460603|E4|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625123|NCT00460564|P4|Participant Flow|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625124|NCT00460564|P3|Participant Flow|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625266|NCT00460525|E1|Reported Event|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625094|NCT00460603|E3|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625095|NCT00460603|E2|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625096|NCT00460603|E1|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
625097|NCT00460577|B3|Baseline|Total|Total of all reporting groups
625098|NCT00460577|B2|Baseline|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625099|NCT00460577|B1|Baseline|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625100|NCT00460577|P2|Participant Flow|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625101|NCT00460577|P1|Participant Flow|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625102|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625103|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625104|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625105|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625106|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625107|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625108|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625109|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625110|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625111|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625112|NCT00460577|E2|Reported Event|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
625113|NCT00460577|E1|Reported Event|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
625114|NCT00460564|B5|Baseline|Total|Total of all reporting groups
625115|NCT00460564|B4|Baseline|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625116|NCT00460564|B3|Baseline|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625117|NCT00460564|B2|Baseline|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625118|NCT00460564|B1|Baseline|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625119|NCT00460564|P8|Participant Flow|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625120|NCT00460564|P7|Participant Flow|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625267|NCT00460434|B3|Baseline|Total|Total of all reporting groups
625128|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625129|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625130|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625131|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625132|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625133|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625134|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625135|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625136|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625137|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625138|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625139|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625140|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625141|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625180|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
626404|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
625142|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625143|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625144|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625145|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625146|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625147|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625148|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625149|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625150|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625151|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625152|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625153|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625154|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625155|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625181|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625583|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625156|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625157|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625158|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625159|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625160|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625161|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625162|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625163|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625164|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625165|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625166|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625167|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625168|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625169|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625170|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625171|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625172|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625173|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625257|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625182|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625183|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625184|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625185|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625186|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625187|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625188|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625189|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625190|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625191|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625192|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625193|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625194|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625195|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625196|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625197|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625198|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625199|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625200|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625201|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625202|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625203|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625204|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625205|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625206|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625207|NCT00460564|O2|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625208|NCT00460564|O1|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625209|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625210|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625258|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625211|NCT00460564|E8|Reported Event|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625212|NCT00460564|E7|Reported Event|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625213|NCT00460564|E6|Reported Event|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625214|NCT00460564|E5|Reported Event|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
625215|NCT00460564|E4|Reported Event|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625216|NCT00460564|E3|Reported Event|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
625217|NCT00460564|E2|Reported Event|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625218|NCT00460564|E1|Reported Event|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
625219|NCT00460551|B1|Baseline|Zalutumumab 8 mg/kg|
625220|NCT00460551|P1|Participant Flow|Zalutumumab 8 mg/kg|
625221|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
625222|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
625223|NCT00460551|E1|Reported Event|Zalutumumab 8 mg/kg|
625224|NCT00460525|B3|Baseline|Total|Total of all reporting groups
625225|NCT00460525|B2|Baseline|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625226|NCT00460525|B1|Baseline|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625227|NCT00460525|P2|Participant Flow|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625228|NCT00460525|P1|Participant Flow|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625229|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625230|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625231|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625232|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625233|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625234|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625235|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625236|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625237|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625238|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625239|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625240|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625241|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625242|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625243|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625244|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625245|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625246|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625247|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625248|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625249|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625250|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625251|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625252|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625253|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625254|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625255|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
625256|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
625268|NCT00460434|B2|Baseline|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625269|NCT00460434|B1|Baseline|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625270|NCT00460434|P2|Participant Flow|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625271|NCT00460434|P1|Participant Flow|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625272|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625273|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625274|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625275|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625276|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625277|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625278|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625279|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625280|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625281|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625282|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625283|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625284|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625285|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625286|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625287|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625288|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625289|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625290|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625291|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625292|NCT00460434|O2|Outcome|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625293|NCT00460434|O1|Outcome|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625294|NCT00460434|E2|Reported Event|Sham Incision|Women in this arm received two one-centimeter suprapubic incisions, comparable to those received in the intervention group.
625295|NCT00460434|E1|Reported Event|Midurethral Sling|Women in this arm received a concomitant tension-free vaginal tape (TVT) procedure.
625296|NCT00460421|B4|Baseline|Total|Total of all reporting groups
625297|NCT00460421|B3|Baseline|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625298|NCT00460421|B2|Baseline|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625299|NCT00460421|B1|Baseline|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625300|NCT00460421|P3|Participant Flow|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625301|NCT00460421|P2|Participant Flow|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625302|NCT00460421|P1|Participant Flow|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625303|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
625304|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625305|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625306|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625307|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
625308|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625309|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625310|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625311|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625312|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625313|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625314|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625315|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625316|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625317|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625318|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625319|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625320|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625321|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625322|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625323|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625324|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625325|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625326|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625327|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625328|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625329|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625330|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625331|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625332|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625333|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625334|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625335|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625336|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625337|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625338|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625339|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625340|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625341|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625342|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625343|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
625344|NCT00460421|E1|Reported Event|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
625345|NCT00460408|B5|Baseline|Total|Total of all reporting groups
625346|NCT00460408|B4|Baseline|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625347|NCT00460408|B3|Baseline|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625348|NCT00460408|B2|Baseline|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625349|NCT00460408|B1|Baseline|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625350|NCT00460408|P4|Participant Flow|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625351|NCT00460408|P3|Participant Flow|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625352|NCT00460408|P2|Participant Flow|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625353|NCT00460408|P1|Participant Flow|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625354|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625355|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625356|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625357|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625358|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625359|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625360|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625361|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625362|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625363|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625364|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625365|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625366|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625367|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625368|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625369|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625370|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625371|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625372|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625584|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
626405|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
625373|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625374|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625375|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625376|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625377|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625378|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625379|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625380|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625381|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625382|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625383|NCT00460408|E4|Reported Event|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
625384|NCT00460408|E3|Reported Event|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625385|NCT00460408|E2|Reported Event|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
625386|NCT00460408|E1|Reported Event|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
625387|NCT00460265|B3|Baseline|Total|Total of all reporting groups
625388|NCT00460265|B2|Baseline|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625389|NCT00460265|B1|Baseline|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625390|NCT00460265|P2|Participant Flow|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625391|NCT00460265|P1|Participant Flow|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625392|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625393|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625394|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625395|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625396|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625397|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625398|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625399|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625400|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625401|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625402|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
625403|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
625404|NCT00460265|E2|Reported Event|Chemotherapy Alone|
625405|NCT00460265|E1|Reported Event|Panitumumab Plus Chemotherapy|
625406|NCT00460239|B1|Baseline|All Study Participants|All Study Participants
625407|NCT00460239|P9|Participant Flow|Condition 9|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, B8, B16, B32, M30, P, B48, B60.
625408|NCT00460239|P8|Participant Flow|Condition 8|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): P, M30, M15, B8, B16, B32, B48, B60.
626406|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
625409|NCT00460239|P7|Participant Flow|Condition 7|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M30, B8, P, B16, M15, B32, B48, B60.
625410|NCT00460239|P6|Participant Flow|Condition 6|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, P, B8, M30, B16, B32, P, B48, B60.
625411|NCT00460239|P5|Participant Flow|Condition 5|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, M30, B32, P, B48, M15, B60.
625412|NCT00460239|P4|Participant Flow|Condition 4|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, M15, B16, P, B32, M30, B48, B60.
625413|NCT00460239|P3|Participant Flow|Condition 3|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, M30, B60, P, M15.
625414|NCT00460239|P2|Participant Flow|Condition 2|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, M15, B48, P, B60, M30.
625415|NCT00460239|P1|Participant Flow|Condition 1|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, B60, M15, M30, P.
625416|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625417|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625418|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625419|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625420|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625421|NCT00460239|O3|Outcome|Morphine 30 mg|
625422|NCT00460239|O2|Outcome|Morphine 15 mg|
625423|NCT00460239|O1|Outcome|Placebo 0 mg|
625424|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625425|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625426|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625427|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625428|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625429|NCT00460239|O3|Outcome|Morphine 30 mg|
625430|NCT00460239|O2|Outcome|Morphine 15 mg|
625431|NCT00460239|O1|Outcome|Placebo 0 mg|
625432|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625433|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625434|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625435|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625436|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625437|NCT00460239|O3|Outcome|Morphine 30 mg|
625438|NCT00460239|O2|Outcome|Morphine 15 mg|
625439|NCT00460239|O1|Outcome|Placebo 0 mg|
625440|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625441|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625442|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625443|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625444|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625445|NCT00460239|O3|Outcome|Morphine 30 mg|
625446|NCT00460239|O2|Outcome|Morphine 15 mg|
625447|NCT00460239|O1|Outcome|Placebo 0 mg|
625448|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625449|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625450|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625451|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625452|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625453|NCT00460239|O3|Outcome|Morphine 30 mg|
625454|NCT00460239|O2|Outcome|Morphine 15 mg|
625455|NCT00460239|O1|Outcome|Placebo 0 mg|
625456|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625457|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625458|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625459|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625460|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625461|NCT00460239|O3|Outcome|Morphine 30 mg|
625462|NCT00460239|O2|Outcome|Morphine 15 mg|
625463|NCT00460239|O1|Outcome|Placebo 0 mg|
625464|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625465|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625466|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625467|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625468|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625469|NCT00460239|O3|Outcome|Morphine 30 mg|
625470|NCT00460239|O2|Outcome|Morphine 15 mg|
625471|NCT00460239|O1|Outcome|Placebo 0 mg|
625472|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
625473|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
625474|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
625475|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
625476|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
625477|NCT00460239|O3|Outcome|Morphine 30 mg|
625478|NCT00460239|O2|Outcome|Morphine 15 mg|
625479|NCT00460239|O1|Outcome|Placebo 0 mg|
625480|NCT00460239|E3|Reported Event|Buprenorphine Intervention|
625481|NCT00460239|E2|Reported Event|Morphine Intervention|
625482|NCT00460239|E1|Reported Event|Placebo Intervention|
626407|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
625483|NCT00460109|B1|Baseline|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625484|NCT00460109|P1|Participant Flow|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625485|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625486|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625487|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625488|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625489|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625490|NCT00460109|E1|Reported Event|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
625491|NCT00460031|B1|Baseline|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625492|NCT00460031|P1|Participant Flow|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625493|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625494|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625495|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625496|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625497|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625498|NCT00460031|E1|Reported Event|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
625499|NCT00459979|B1|Baseline|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625500|NCT00459979|P1|Participant Flow|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625501|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625502|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625503|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625504|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625505|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625506|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625507|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625508|NCT00459979|E1|Reported Event|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
625509|NCT00459953|B3|Baseline|Total|Total of all reporting groups
625510|NCT00459953|B2|Baseline|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
625511|NCT00459953|B1|Baseline|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
625512|NCT00459953|P2|Participant Flow|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
625513|NCT00459953|P1|Participant Flow|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
625514|NCT00459953|O2|Outcome|Control Group|Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
625515|NCT00459953|O1|Outcome|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
625516|NCT00459953|E2|Reported Event|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
625517|NCT00459953|E1|Reported Event|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
625518|NCT00459875|B1|Baseline|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
625519|NCT00459875|P1|Participant Flow|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
625520|NCT00459875|O1|Outcome|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
625521|NCT00459875|E1|Reported Event|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
625522|NCT00459862|B1|Baseline|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625523|NCT00459862|P1|Participant Flow|Arm I|Patients receive 800mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625524|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625525|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625526|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625527|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625528|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625529|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625530|NCT00459862|E1|Reported Event|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
625531|NCT00459810|B1|Baseline|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625532|NCT00459810|P1|Participant Flow|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625533|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625585|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625534|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625535|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625536|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625537|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625538|NCT00459810|E1|Reported Event|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
625539|NCT00459732|B3|Baseline|Total|Total of all reporting groups
625540|NCT00459732|B2|Baseline|Placebo|daily capsule similar in size/color to zn was taken daily by this group
625541|NCT00459732|B1|Baseline|Zinc|25 mg of zinc as zn sulfate taken daily
625542|NCT00459732|P2|Participant Flow|Placebo|daily capsule similar in size/color to zn was taken daily by this group
625543|NCT00459732|P1|Participant Flow|Zinc|25 mg of zinc as zn sulfate taken daily
625544|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
625545|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
625546|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
625547|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
625548|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
625549|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
625550|NCT00459732|E2|Reported Event|Placebo|daily capsule similar in size/color to zn was taken daily by this group
625551|NCT00459732|E1|Reported Event|Zinc|25 mg of zinc as zn sulfate taken daily
625552|NCT00459706|B3|Baseline|Total|Total of all reporting groups
625553|NCT00459706|B2|Baseline|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625554|NCT00459706|B1|Baseline|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625555|NCT00459706|P2|Participant Flow|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625556|NCT00459706|P1|Participant Flow|Enbrel 50 mg Autoinjector|Enbrel 50 milligram (mg) once weekly subcutaneously for 12 Weeks using autoinjector
625557|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625558|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625559|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625560|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625561|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625562|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625563|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625564|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625565|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625566|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625567|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625568|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625569|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625570|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625571|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625572|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625573|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625574|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625575|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625576|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625577|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625578|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625579|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625580|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625581|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625582|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
646263|NCT00410761|O2|Outcome|Placebo|Placebo daily
625586|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625587|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625588|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625589|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625590|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625591|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625592|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625593|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625594|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625595|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625596|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625597|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625598|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625599|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625600|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625601|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625602|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625603|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625604|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625605|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625606|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625607|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625608|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625609|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625610|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625611|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625612|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625613|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625614|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625615|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625616|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625617|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625618|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625619|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625620|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625621|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625622|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625623|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625624|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625625|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625626|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625627|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625628|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625629|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625630|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625631|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625632|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625633|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625634|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625635|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625636|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625637|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625638|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625639|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625640|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625641|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625642|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625643|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625644|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625645|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625646|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625647|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625648|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625649|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625650|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625651|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625652|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625653|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625654|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625655|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625656|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625657|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625658|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625659|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625660|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625661|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625662|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625663|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625664|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625665|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625666|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625667|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625668|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625669|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625670|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625671|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625672|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625673|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625674|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625675|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625676|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625677|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625678|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625679|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625680|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625681|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625682|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625683|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625684|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625685|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625686|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625687|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625688|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625689|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625690|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625691|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625692|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625693|NCT00459706|E2|Reported Event|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
625694|NCT00459706|E1|Reported Event|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
625695|NCT00459667|B4|Baseline|Total|Total of all reporting groups
625696|NCT00459667|B3|Baseline|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625697|NCT00459667|B2|Baseline|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625698|NCT00459667|B1|Baseline|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625699|NCT00459667|P3|Participant Flow|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625700|NCT00459667|P2|Participant Flow|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625701|NCT00459667|P1|Participant Flow|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625702|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625703|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625704|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625705|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625706|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625707|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625708|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625709|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625710|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625711|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625712|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625713|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625714|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625715|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625716|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625717|NCT00459667|E3|Reported Event|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
625718|NCT00459667|E2|Reported Event|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
625719|NCT00459667|E1|Reported Event|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
625720|NCT00459537|B3|Baseline|Total|Total of all reporting groups
625721|NCT00459537|B2|Baseline|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625722|NCT00459537|B1|Baseline|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625723|NCT00459537|P2|Participant Flow|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625724|NCT00459537|P1|Participant Flow|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625725|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625726|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625727|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625840|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
625728|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625729|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625730|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625731|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625732|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625733|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625734|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625735|NCT00459537|E2|Reported Event|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
625736|NCT00459537|E1|Reported Event|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
625737|NCT00459381|B1|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625738|NCT00459381|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625739|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625740|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625741|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625742|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625743|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625744|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625745|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625746|NCT00459381|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
625747|NCT00459368|B3|Baseline|Total|Total of all reporting groups
625748|NCT00459368|B2|Baseline|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
625749|NCT00459368|B1|Baseline|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
625750|NCT00459368|P2|Participant Flow|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
625751|NCT00459368|P1|Participant Flow|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
625752|NCT00459368|O2|Outcome|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
625753|NCT00459368|O1|Outcome|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
625754|NCT00459368|E2|Reported Event|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
625755|NCT00459368|E1|Reported Event|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
625756|NCT00459355|B3|Baseline|Total|Total of all reporting groups
625757|NCT00459355|B2|Baseline|Checklist|Received conventional home safety checklist
625758|NCT00459355|B1|Baseline|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
625759|NCT00459355|P2|Participant Flow|Checklist|Group receives conventional home safety checklist
625760|NCT00459355|P1|Participant Flow|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
625761|NCT00459355|O2|Outcome|Conventional Safety Checklist|Comparison group received a conventional home safety checklist
625762|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
625763|NCT00459355|O2|Outcome|Checklist|Conventional home safety checklist
625764|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
625765|NCT00459355|O2|Outcome|Checklist|non-intervention group received conventional home safety checklist
625766|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
625767|NCT00459355|E4|Reported Event|Checklist:Caregivers|Control group receives conventional list of home safety recommendations
625768|NCT00459355|E3|Reported Event|Home Safety Toolkit:Caregivers|Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
625769|NCT00459355|E2|Reported Event|Checklist:Care Recipients|Control group receives conventional list of home safety recommendations
625770|NCT00459355|E1|Reported Event|Home Safety Toolkit:Care Recipients|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
625771|NCT00459342|B1|Baseline|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
625772|NCT00459342|P1|Participant Flow|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
625773|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
625774|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
625775|NCT00459342|E1|Reported Event|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
625776|NCT00459316|B5|Baseline|Total|Total of all reporting groups
625777|NCT00459316|B4|Baseline|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625778|NCT00459316|B3|Baseline|Group 2|Participants ≥11 to <25 years with CD4%<15
625779|NCT00459316|B2|Baseline|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
625780|NCT00459316|B1|Baseline|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%<25
625781|NCT00459316|P3|Participant Flow|Group 3: Age ≥2 to <11, CD4%≥25|"Participants ≥2 to <11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
625782|NCT00459316|P2|Participant Flow|Group 2: CD4%<15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening <15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
625783|NCT00459316|P1|Participant Flow|Group 1: CD4%≥15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
625784|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25, 2 doses MCV4 vaccine
625785|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
625786|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625787|NCT00459316|O2|Outcome|Group 3|Participants >=2 to <11 years of age with CD4% at screening ≥ 25%
625788|NCT00459316|O1|Outcome|Group 1|Participants ≤11 to <25 years of age with CD4% at screening ≥15%
625789|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
625790|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625791|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
625792|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625793|NCT00459316|O4|Outcome|Group 3: Age 6-<11|Participants 6 to <11 years with CD4%>=25
625794|NCT00459316|O3|Outcome|Group 3: Age 2-<6|Participants 2 to <6 years with CD4%>=25
625795|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
625796|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625797|NCT00459316|O3|Outcome|Week 72|Group 2 participants at Week 72
625798|NCT00459316|O2|Outcome|Week 28|Group 2 participants at Week 28 (4 weeks after second vaccination)
625799|NCT00459316|O1|Outcome|Week 4|Group 2 participants at Week 4
625800|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625801|NCT00459316|O2|Outcome|Group 1B|Participants aged 11 to 24 with a CD4 percentage of or greater than 15%, 2 doses MCV4 vaccine
625802|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625803|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625804|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
625805|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625806|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625807|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
625808|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625809|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625810|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
625811|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
625812|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625813|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
625814|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
625815|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
625816|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
625817|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
625818|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
625819|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
625820|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
625821|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
625822|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
625823|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
625824|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
625825|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
625826|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
625827|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
625828|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625829|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
625830|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
625831|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
625832|NCT00459316|E4|Reported Event|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
625833|NCT00459316|E3|Reported Event|Group 2|Participants ≥11 to <25 years with CD4%<15
625834|NCT00459316|E2|Reported Event|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
625835|NCT00459316|E1|Reported Event|Group 1 (15<CD4%≤25)|Participants ≥11 to <25 years with 15<CD4%≤25
625836|NCT00459303|B1|Baseline|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
625837|NCT00459303|P1|Participant Flow|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.
625838|NCT00459303|O2|Outcome|Aspheric Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
625839|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
646264|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
625841|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
625842|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
625843|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
625844|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
625845|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
625846|NCT00459303|E1|Reported Event|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
625847|NCT00459290|B1|Baseline|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
625848|NCT00459290|P1|Participant Flow|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
625849|NCT00459290|O3|Outcome|>=70|
625850|NCT00459290|O2|Outcome|60 <70|
625851|NCT00459290|O1|Outcome|< 60|
625852|NCT00459290|O2|Outcome|GOG Performance Status 1|Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
625853|NCT00459290|O1|Outcome|GOG Performance Status 0|Fully active, able to carry on all pre-disease performance without restriction.
625854|NCT00459290|O2|Outcome|Platinum Sensitive|
625855|NCT00459290|O1|Outcome|Not Platinum Sensitive|
625856|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
625857|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
625858|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
625859|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
625860|NCT00459290|E1|Reported Event|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
625861|NCT00459186|B1|Baseline|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
625862|NCT00459186|P1|Participant Flow|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
625863|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
625864|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
625865|NCT00459186|E1|Reported Event|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
625866|NCT00459134|B3|Baseline|Total|Total of all reporting groups
625867|NCT00459134|B2|Baseline|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
625868|NCT00459134|B1|Baseline|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
625869|NCT00459134|P2|Participant Flow|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
625870|NCT00459134|P1|Participant Flow|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
625871|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
625872|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
625873|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
625874|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
625875|NCT00459134|E2|Reported Event|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
625876|NCT00459134|E1|Reported Event|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
625877|NCT00459121|B1|Baseline|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
625878|NCT00459121|P1|Participant Flow|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
625879|NCT00459121|O1|Outcome|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
625880|NCT00459121|E1|Reported Event|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
625881|NCT00459108|B1|Baseline|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625882|NCT00459108|P1|Participant Flow|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625883|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625884|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625885|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625886|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625887|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625888|NCT00459108|E1|Reported Event|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
625889|NCT00459056|B3|Baseline|Total|Total of all reporting groups
625890|NCT00459056|B2|Baseline|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
625891|NCT00459056|B1|Baseline|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
625892|NCT00459056|P2|Participant Flow|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCT for three months, then had a one month wash-out period, and then were randomized to Carvedilol CR + Lisinopril for the remaining three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, Lisinophil was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
625893|NCT00459056|P1|Participant Flow|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for three months, then had a one month wash-out period, and then were randomized to Lisinopril + HCT for the remaining three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
625894|NCT00459056|O2|Outcome|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisionopril +HCTZ for the first three months, then had a one month washout period, then were given Carvedilol CR + Lisinopril for the final three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
625895|NCT00459056|O1|Outcome|Carvedilol CR + Lisinopril, Then Lisinopril +HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a one month washout period, then were given Lisinopril + HCTZ for the final three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
625896|NCT00459056|E2|Reported Event|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
625897|NCT00459056|E1|Reported Event|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
625898|NCT00459043|B3|Baseline|Total|Total of all reporting groups
625899|NCT00459043|B2|Baseline|Combination of Docetaxel and Zactima|
625900|NCT00459043|B1|Baseline|Docetaxel Single Agent|
625979|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625901|NCT00459043|P2|Participant Flow|2 Combination Docetaxel and ZD6474|"Docetaxel with ZD6474~Docetaxel 75 mg/m2 was administered every 21 days intravenously. ZD6474 (Vandetanib) at 100 mg was administered as a once daily tablet given orally."
625902|NCT00459043|P1|Participant Flow|1Docetaxel Single Agent|Docetaxel 75 mg/m2 was administered every 21 days intravenously.
625903|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
625904|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
625905|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
625906|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
625907|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
625908|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
625909|NCT00459043|E2|Reported Event|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
625910|NCT00459043|E1|Reported Event|1Docetaxel Single Agent|Docetaxel Alone
625911|NCT00458952|B3|Baseline|Total|Total of all reporting groups
625912|NCT00458952|B2|Baseline|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
625913|NCT00458952|B1|Baseline|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
625914|NCT00458952|P2|Participant Flow|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
625915|NCT00458952|P1|Participant Flow|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
625916|NCT00458952|O1|Outcome|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
625917|NCT00458952|E1|Reported Event|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
625918|NCT00458822|B1|Baseline|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
625919|NCT00458822|P1|Participant Flow|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
625920|NCT00458822|O1|Outcome|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
625921|NCT00458822|E1|Reported Event|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
625922|NCT00458705|B1|Baseline|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
625923|NCT00458705|P1|Participant Flow|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
625924|NCT00458705|O1|Outcome|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
625925|NCT00458705|E1|Reported Event|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
625926|NCT00458536|B1|Baseline|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
625927|NCT00458536|P1|Participant Flow|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
625928|NCT00458536|O1|Outcome|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
625980|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625929|NCT00458536|E1|Reported Event|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
625930|NCT00458406|B3|Baseline|Total|Total of all reporting groups
625931|NCT00458406|B2|Baseline|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
625932|NCT00458406|B1|Baseline|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
625933|NCT00458406|P2|Participant Flow|CPAP|"Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.~Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.~In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=13 were enrolled into the CPAP arm."
625934|NCT00458406|P1|Participant Flow|Bi-Flex|"Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study. Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=43 were enrolled into the Bi-Flex arm."
625935|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
625936|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
625937|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
625938|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
625939|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
625940|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
625941|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
625942|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
625943|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
625944|NCT00458406|O1|Outcome|BiFlex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
625945|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
625946|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
625947|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
625948|NCT00458406|O1|Outcome|Bi-Flex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
625949|NCT00458406|E2|Reported Event|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
625950|NCT00458406|E1|Reported Event|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
625951|NCT00458393|B3|Baseline|Total|Total of all reporting groups
625952|NCT00458393|B2|Baseline|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625953|NCT00458393|B1|Baseline|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625954|NCT00458393|P2|Participant Flow|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625955|NCT00458393|P1|Participant Flow|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625956|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625957|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625958|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625959|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625960|NCT00458393|O2|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625961|NCT00458393|O1|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625962|NCT00458393|O2|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625963|NCT00458393|O1|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625964|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625965|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625966|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625967|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625968|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625969|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625970|NCT00458393|O2|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625971|NCT00458393|O1|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625972|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625973|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625974|NCT00458393|O2|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625975|NCT00458393|O1|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625976|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625977|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625978|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625984|NCT00458393|O2|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625985|NCT00458393|O1|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625986|NCT00458393|O2|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625987|NCT00458393|O1|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625988|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625989|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625990|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625991|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625992|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625993|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625994|NCT00458393|O2|Outcome|Placebo|Daily oral placebo
625995|NCT00458393|O1|Outcome|TDF/FTC|Daily oral emtricitabine/tenofovir disoproxil fumarate
625996|NCT00458393|O2|Outcome|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625997|NCT00458393|O1|Outcome|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
625998|NCT00458393|E2|Reported Event|Placebo|"Daily oral placebo~Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate"
625999|NCT00458393|E1|Reported Event|TDF/FTC|"Daily oral emtricitabine/tenofovir disoproxil fumarate~Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate"
626000|NCT00458302|B3|Baseline|Total|Total of all reporting groups
626001|NCT00458302|B2|Baseline|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626002|NCT00458302|B1|Baseline|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626003|NCT00458302|P2|Participant Flow|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626004|NCT00458302|P1|Participant Flow|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626005|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626006|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626007|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626008|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626009|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626010|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626011|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626012|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626013|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626014|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626015|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626016|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626017|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626018|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626019|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626020|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626021|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626022|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626023|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626024|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626025|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626026|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626027|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626028|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626029|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626030|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626031|NCT00458302|E3|Reported Event|Total|
626032|NCT00458302|E2|Reported Event|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
626033|NCT00458302|E1|Reported Event|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
626034|NCT00458237|B4|Baseline|Total|Total of all reporting groups
626035|NCT00458237|B3|Baseline|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626036|NCT00458237|B2|Baseline|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626037|NCT00458237|B1|Baseline|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626121|NCT00457821|E5|Reported Event|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
626124|NCT00457821|E2|Reported Event|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
626038|NCT00458237|P3|Participant Flow|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626039|NCT00458237|P2|Participant Flow|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626040|NCT00458237|P1|Participant Flow|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626041|NCT00458237|O2|Outcome|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626042|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626043|NCT00458237|O2|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626044|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626045|NCT00458237|E3|Reported Event|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626046|NCT00458237|E2|Reported Event|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626047|NCT00458237|E1|Reported Event|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
626048|NCT00458211|B1|Baseline|Experimental|Open label change to ziprasidone
626049|NCT00458211|P1|Participant Flow|Experimental|Open label change to ziprasidone up to 120mg twice a day with meals
626050|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
626051|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
626052|NCT00458211|O1|Outcome|Experimental|All subjects, 17 at Buffalo and 19 at Bronx were given Ziprasidone.
626053|NCT00458211|O1|Outcome|Experimental|
626054|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
626055|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
626056|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
626057|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
626058|NCT00458211|E1|Reported Event|Experimental|Open label change to ziprasidone
626059|NCT00457977|B3|Baseline|Total|Total of all reporting groups
626060|NCT00457977|B2|Baseline|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
626061|NCT00457977|B1|Baseline|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
626062|NCT00457977|P2|Participant Flow|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
626063|NCT00457977|P1|Participant Flow|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
626064|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
626065|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
626066|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
626067|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
626068|NCT00457977|E2|Reported Event|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
626069|NCT00457977|E1|Reported Event|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
626070|NCT00457951|B4|Baseline|Total|Total of all reporting groups
626071|NCT00457951|B3|Baseline|ODSH Treatment Group|ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
626072|NCT00457951|B2|Baseline|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
626073|NCT00457951|B1|Baseline|Open-Label|Open-Label ODSH
626074|NCT00457951|P3|Participant Flow|ODSH Treatment Group|Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.
626075|NCT00457951|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.
626122|NCT00457821|E4|Reported Event|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
626123|NCT00457821|E3|Reported Event|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
626076|NCT00457951|P1|Participant Flow|Open Label|"Open Label~The original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.~After an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis."
626077|NCT00457951|O2|Outcome|Randomized, Blinded, ODSH Arm|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
626078|NCT00457951|O1|Outcome|0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
626079|NCT00457951|E3|Reported Event|ODSH Treatment Group|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
626080|NCT00457951|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
626081|NCT00457951|E1|Reported Event|Open Label|"Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.~Open-Label: ODSH administered open-label"
626082|NCT00457821|B9|Baseline|Total|Total of all reporting groups
626083|NCT00457821|B8|Baseline|Part 2: Placebo|Part 2: placebo q12h; 28 days
626084|NCT00457821|B7|Baseline|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
626085|NCT00457821|B6|Baseline|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
626086|NCT00457821|B5|Baseline|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
626087|NCT00457821|B4|Baseline|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
626088|NCT00457821|B3|Baseline|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
626089|NCT00457821|B2|Baseline|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
626090|NCT00457821|B1|Baseline|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
626091|NCT00457821|P8|Participant Flow|Part 2: Placebo|Part 2: placebo q12h; 28 days
626092|NCT00457821|P7|Participant Flow|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
626093|NCT00457821|P6|Participant Flow|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
626094|NCT00457821|P5|Participant Flow|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
626095|NCT00457821|P4|Participant Flow|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
626096|NCT00457821|P3|Participant Flow|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
626097|NCT00457821|P2|Participant Flow|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
626098|NCT00457821|P1|Participant Flow|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
626099|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
626100|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
626101|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
626102|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
626103|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
626104|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
626105|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
626106|NCT00457821|O3|Outcome|250 mg Ivacaftor q12h|Subjects given 250 mg of ivacaftor q12h for 28 days.
626107|NCT00457821|O2|Outcome|150 mg Ivacaftor q12h|Subjects given 150 mg of ivacaftor q12h for 28 days.
626108|NCT00457821|O1|Outcome|Placebo|Subjects given placebo every 12 hours (q12h) for 28 days.
626109|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
626110|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
626111|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
626112|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
626113|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
626114|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
626115|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
626116|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
626117|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
626118|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
626119|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
626120|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
626125|NCT00457821|E1|Reported Event|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
626126|NCT00457795|B1|Baseline|Brimonidine 0.1%|Brimonidine 0.1%
626127|NCT00457795|P1|Participant Flow|Brimonidine 0.1%|Brimonidine 0.1%
626128|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
626129|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
626130|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
626131|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
626132|NCT00457795|E1|Reported Event|Brimonidine 0.1%|Brimonidine 0.1%
626133|NCT00457743|B4|Baseline|Total|Total of all reporting groups
626134|NCT00457743|B3|Baseline|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626135|NCT00457743|B2|Baseline|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626136|NCT00457743|B1|Baseline|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626137|NCT00457743|P3|Participant Flow|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626138|NCT00457743|P2|Participant Flow|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626139|NCT00457743|P1|Participant Flow|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626140|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626141|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626142|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626408|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626143|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626144|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626145|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626146|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626147|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626148|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626149|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626150|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626151|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626152|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626235|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626409|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626153|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626154|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626155|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626156|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626157|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626158|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626159|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626160|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626161|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626162|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626236|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626163|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626164|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626165|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626166|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626167|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626168|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626169|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626170|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626171|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626172|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626410|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626173|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626174|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626175|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626176|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626177|NCT00457743|E3|Reported Event|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626178|NCT00457743|E2|Reported Event|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
626179|NCT00457743|E1|Reported Event|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
626180|NCT00457730|B3|Baseline|Total|Total of all reporting groups
626181|NCT00457730|B2|Baseline|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
626182|NCT00457730|B1|Baseline|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
626183|NCT00457730|P2|Participant Flow|Placebo|subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
626184|NCT00457730|P1|Participant Flow|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
626185|NCT00457730|O2|Outcome|Placebo|matched placebo medication with same periods
626186|NCT00457730|O1|Outcome|Duloxetine|Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week
626187|NCT00457730|O2|Outcome|Placebo|matched placebo medication throughout 6 week observation period
626188|NCT00457730|O1|Outcome|Duloxetine|ubjects will take 30 mg daily for 1 week, then 60 mg daily for 5 weeks, then titrate back down to 30 mg daily for 1 week.
626237|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626411|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626189|NCT00457730|O2|Outcome|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
626190|NCT00457730|O1|Outcome|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
626191|NCT00457730|E2|Reported Event|Placebo|Placebo: Matching placebo drug for 7 weeks total
626192|NCT00457730|E1|Reported Event|Duloxetine|Study drug, Duloxetine, 30 mg for 1 week, titrate up to 60 mg for 5 weeks and titrate back down to 30 mg for 1 week.
626193|NCT00457691|B3|Baseline|Total|Total of all reporting groups
626194|NCT00457691|B2|Baseline|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626195|NCT00457691|B1|Baseline|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626196|NCT00457691|P2|Participant Flow|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626197|NCT00457691|P1|Participant Flow|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626198|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626199|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626200|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626201|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626202|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626203|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626204|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626205|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626206|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626238|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626412|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626207|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626208|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626209|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626210|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626211|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626212|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626213|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626214|NCT00457691|E2|Reported Event|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
626215|NCT00457691|E1|Reported Event|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
626216|NCT00457418|B1|Baseline|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626217|NCT00457418|P1|Participant Flow|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626218|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626219|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626220|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626221|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626222|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626223|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626224|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626225|NCT00457418|E1|Reported Event|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
626226|NCT00457392|B3|Baseline|Total|Total of all reporting groups
626227|NCT00457392|B2|Baseline|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626228|NCT00457392|B1|Baseline|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626229|NCT00457392|P2|Participant Flow|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626230|NCT00457392|P1|Participant Flow|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626231|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626232|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626233|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626234|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
646265|NCT00410761|O2|Outcome|Placebo|Placebo daily
626239|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626240|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626241|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626242|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626243|NCT00457392|E2|Reported Event|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
626244|NCT00457392|E1|Reported Event|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
626245|NCT00457301|B3|Baseline|Total|Total of all reporting groups
626246|NCT00457301|B2|Baseline|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
626247|NCT00457301|B1|Baseline|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
626248|NCT00457301|P2|Participant Flow|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
626249|NCT00457301|P1|Participant Flow|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
626250|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
626251|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
626252|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
626253|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
626254|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
626255|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
626256|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
626257|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
626258|NCT00457301|E2|Reported Event|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
626259|NCT00457301|E1|Reported Event|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
626260|NCT00457249|B3|Baseline|Total|Total of all reporting groups
626261|NCT00457249|B2|Baseline|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626262|NCT00457249|B1|Baseline|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626263|NCT00457249|P2|Participant Flow|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
626264|NCT00457249|P1|Participant Flow|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626265|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626266|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626267|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626268|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626269|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
626270|NCT00457249|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626271|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626272|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626273|NCT00457249|E2|Reported Event|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626274|NCT00457249|E1|Reported Event|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
626275|NCT00457197|B3|Baseline|Total|Total of all reporting groups
626276|NCT00457197|B2|Baseline|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626277|NCT00457197|B1|Baseline|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626399|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626400|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626278|NCT00457197|P2|Participant Flow|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626279|NCT00457197|P1|Participant Flow|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626280|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626281|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626282|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626283|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626284|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626285|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626286|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626287|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626288|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626289|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626290|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626291|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626292|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626293|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626294|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626295|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626296|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626297|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626298|NCT00457197|E2|Reported Event|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
626401|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626299|NCT00457197|E1|Reported Event|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
626300|NCT00457015|B3|Baseline|Total|Total of all reporting groups
626301|NCT00457015|B2|Baseline|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626302|NCT00457015|B1|Baseline|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626303|NCT00457015|P2|Participant Flow|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626304|NCT00457015|P1|Participant Flow|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626305|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626306|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626307|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626308|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626309|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626310|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626311|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626312|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626313|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626314|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626315|NCT00457015|E2|Reported Event|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
626316|NCT00457015|E1|Reported Event|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
626317|NCT00457002|B3|Baseline|Total|Total of all reporting groups
626318|NCT00457002|B2|Baseline|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626319|NCT00457002|B1|Baseline|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626320|NCT00457002|P2|Participant Flow|Enoxaparin 40 mg Subcutaneous|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626321|NCT00457002|P1|Participant Flow|Apixaban 2.5 mg Oral|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626322|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626323|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626324|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626325|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626326|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626327|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626328|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626329|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626330|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626331|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626332|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626333|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626334|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626335|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626336|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626337|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626338|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626402|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
646266|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
626339|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626340|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626341|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626342|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626343|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626344|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626345|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626346|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626347|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626348|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626349|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626350|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626351|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626352|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626353|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626354|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626355|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626356|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626357|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626358|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626359|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626360|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626361|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626362|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626363|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626364|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626365|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626366|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626367|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626368|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626369|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626370|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626371|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626372|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626403|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626373|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626374|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626375|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626376|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626377|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626378|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626379|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626380|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626381|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626382|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626383|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626384|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626385|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626386|NCT00457002|E2|Reported Event|Enox 40mg QD|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
626387|NCT00457002|E1|Reported Event|Apix 2.5mg BID|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
626388|NCT00456989|B1|Baseline|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
626389|NCT00456989|P1|Participant Flow|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
626390|NCT00456989|O1|Outcome|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
626391|NCT00456989|E1|Reported Event|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
626392|NCT00456885|B1|Baseline|All Study Participants|All participants in the study.
626393|NCT00456885|P2|Participant Flow|Placebo First, Then Exenatide|Started on placebo, three week washout, started on exenatide.
626394|NCT00456885|P1|Participant Flow|Exenatide First, Then Placebo|Started on exenatide, 3 week washout, started on placebo.
626395|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626396|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626397|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626398|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626413|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626414|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626415|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626416|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626417|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626418|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626419|NCT00456885|O2|Outcome|Placebo|All participants that received placebo.
626420|NCT00456885|O1|Outcome|Exenatide|All participants that received exenatide.
626421|NCT00456885|E1|Reported Event|All Study Participants|
626422|NCT00456846|B3|Baseline|Total|Total of all reporting groups
626423|NCT00456846|B2|Baseline|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626424|NCT00456846|B1|Baseline|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626425|NCT00456846|P2|Participant Flow|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
626426|NCT00456846|P1|Participant Flow|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
626427|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626428|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626429|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626430|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626431|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626432|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626433|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626434|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626435|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626436|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626437|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626438|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626439|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626440|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626441|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626442|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626443|NCT00456846|E2|Reported Event|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626444|NCT00456846|E1|Reported Event|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
626445|NCT00456807|B3|Baseline|Total|Total of all reporting groups
626446|NCT00456807|B2|Baseline|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626447|NCT00456807|B1|Baseline|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626448|NCT00456807|P2|Participant Flow|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626449|NCT00456807|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626450|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626451|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626452|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626453|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626454|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626455|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626456|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626457|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626458|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626459|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626460|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626461|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626462|NCT00456807|E2|Reported Event|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
626463|NCT00456807|E1|Reported Event|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
626464|NCT00456755|B3|Baseline|Total|Total of all reporting groups
626465|NCT00456755|B2|Baseline|Placebo|The placebo contained brown colored starch resembling the SBL powder
626466|NCT00456755|B1|Baseline|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
626467|NCT00456755|P2|Participant Flow|Placebo|The placebo contained brown colored starch resembling the SBL powder
626468|NCT00456755|P1|Participant Flow|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
626469|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
626470|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
626471|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
626472|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
626473|NCT00456755|E2|Reported Event|Placebo|The placebo contained brown colored starch resembling the SBL powder
626474|NCT00456755|E1|Reported Event|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
626475|NCT00456625|B1|Baseline|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
626476|NCT00456625|P1|Participant Flow|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
626477|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
626478|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
626479|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
626480|NCT00456625|E1|Reported Event|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
626481|NCT00456612|B1|Baseline|Single Arm|Single arm Phase II Study
626482|NCT00456612|P1|Participant Flow|Cyberknife|Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
626483|NCT00456612|O1|Outcome|Single Arm|Single arm Phase II Study
626484|NCT00456612|O1|Outcome|Cyberknife|"Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.~CyberKnife: Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses."
626485|NCT00456612|E1|Reported Event|Single Arm Study|Single arm Phase II Study
626486|NCT00456599|B1|Baseline|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
626537|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626487|NCT00456599|P1|Participant Flow|Gemcitabine and Oxaliplatin With Radiation Therapy|Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer.
626488|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
626489|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
626490|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
626491|NCT00456599|E1|Reported Event|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
626492|NCT00456547|B3|Baseline|Total|Total of all reporting groups
626493|NCT00456547|B2|Baseline|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
626494|NCT00456547|B1|Baseline|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
626495|NCT00456547|P2|Participant Flow|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
626496|NCT00456547|P1|Participant Flow|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
626497|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
626498|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
626499|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
626500|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
626501|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
626502|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
626503|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
626504|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
626505|NCT00456547|E2|Reported Event|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
626506|NCT00456547|E1|Reported Event|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
626507|NCT00456521|B3|Baseline|Total|Total of all reporting groups
626508|NCT00456521|B2|Baseline|Placebo|Placebo
626509|NCT00456521|B1|Baseline|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626510|NCT00456521|P2|Participant Flow|Placebo|Placebo
626511|NCT00456521|P1|Participant Flow|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626512|NCT00456521|O2|Outcome|Placebo|Placebo
626513|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626514|NCT00456521|O2|Outcome|Placebo|Placebo
626515|NCT00456521|O1|Outcome|NB32|"Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group behavioral lifestyle modification counseling~naltrexone SR/bupropion SR combination~Intensive group lifestyle modification counseling: Group lifestyle modification counseling"
626516|NCT00456521|O2|Outcome|Placebo|Placebo
626517|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626518|NCT00456521|O2|Outcome|Placebo|Placebo
626519|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626520|NCT00456521|O2|Outcome|Placebo|Placebo
626521|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626522|NCT00456521|O2|Outcome|Placebo|Placebo
626523|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626524|NCT00456521|O2|Outcome|Placebo|Placebo
626525|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626526|NCT00456521|O2|Outcome|Placebo|Placebo
626527|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626528|NCT00456521|O2|Outcome|Placebo|Placebo
626529|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626530|NCT00456521|O2|Outcome|Placebo|Placebo
626531|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626532|NCT00456521|O2|Outcome|Placebo|Placebo
626533|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626534|NCT00456521|O2|Outcome|Placebo|Placebo
626535|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626536|NCT00456521|O2|Outcome|Placebo|Placebo
626538|NCT00456521|O2|Outcome|Placebo|Placebo
626539|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626540|NCT00456521|O2|Outcome|Placebo|Placebo
626541|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626542|NCT00456521|O2|Outcome|Placebo|Placebo
626543|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626544|NCT00456521|O2|Outcome|Placebo|Placebo
626545|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626546|NCT00456521|O2|Outcome|Placebo|Placebo
626547|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626548|NCT00456521|E2|Reported Event|Placebo|Placebo
626549|NCT00456521|E1|Reported Event|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
626550|NCT00456508|B1|Baseline|Treatment|DX-88 (ecallantide)
626551|NCT00456508|P1|Participant Flow|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
626552|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
626553|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
626554|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
626555|NCT00456508|E1|Reported Event|Treatment|DX-88 (ecallantide)
626556|NCT00456495|B1|Baseline|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
626557|NCT00456495|P1|Participant Flow|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
626558|NCT00456495|O1|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks. To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate the number of clock hours of corneal neovascularization, from baseline to month 12, and 24. To report on the number of patients with a decrease in corneal neovascularization.
626559|NCT00456495|O1|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks
626560|NCT00456495|E1|Reported Event|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
626561|NCT00456365|B3|Baseline|Total|Total of all reporting groups
626562|NCT00456365|B2|Baseline|Placebo|"Placebo~Placebo: Placebo daily"
626563|NCT00456365|B1|Baseline|Pravastatin|"Pravastatin~pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)"
626564|NCT00456365|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo daily"
626565|NCT00456365|P1|Participant Flow|Pravastatin|"Pravastatin~pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)"
626566|NCT00456365|O2|Outcome|Placebo|Placebo daily
626567|NCT00456365|O1|Outcome|Pravastatin|Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
626568|NCT00456365|O2|Outcome|Placebo|Placebo daily
626569|NCT00456365|O1|Outcome|Pravastatin|Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
626570|NCT00456365|O2|Outcome|Placebo|"Placebo~Placebo: Placebo daily"
626571|NCT00456365|O1|Outcome|Pravastatin|"Pravastatin~pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)"
626572|NCT00456365|O2|Outcome|Placebo|"Placebo~Placebo: Placebo daily"
626573|NCT00456365|O1|Outcome|Pravastatin|"Pravastatin~pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)"
626574|NCT00456365|E2|Reported Event|Placebo|Placebo daily
626575|NCT00456365|E1|Reported Event|Pravastatin|Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
626576|NCT00456261|B3|Baseline|Total|Total of all reporting groups
626577|NCT00456261|B2|Baseline|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
626578|NCT00456261|B1|Baseline|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
626579|NCT00456261|P2|Participant Flow|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
626600|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626601|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626580|NCT00456261|P1|Participant Flow|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
626581|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
626582|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
626583|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
626584|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
626585|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
626586|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
626587|NCT00456261|E2|Reported Event|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
626588|NCT00456261|E1|Reported Event|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
626589|NCT00456014|B1|Baseline|SSRI|The single arm of this study involves patients with current MDD who will all receive open standardized treatment with escitalopram. There are not multiple arms nor multiple patient groups.
626590|NCT00456014|P1|Participant Flow|Open Standardized Treatment|"Participants will take escitalopram through standardized dosing over an 8 week trial. Non-remitters will be offered entry into a second open treatment phase with standardized treatment with desipramine.~In phase 1, participants will receive escitalopram beginning at 10mg daily for 4 weeks, increasing to 20mg if non-response at week 4 or 6. If participants experience intolerable side-effects, they will be switched to an alternative SSRI, sertraline. Non-remitters after 8 weeks may enter a second phase of standardized treatment, switching from escitalopram to desipramine, dosed by blood level according to a treatment protocol. Those with intolerable side-effects to desipramine will be switched to an alternative tricyclic antidepressant, nortriptyline."
626591|NCT00456014|O1|Outcome|1 - SSRI|Participants will complete an 8-week trial of the SSRI escitalopram, or, if not tolerated, an 8-week trial of the SSRI sertraline.
626592|NCT00456014|O1|Outcome|Tricyclic Group|7 participants who did not remit during the SSRI phase advanced to the tricyclic phase. 4 participants completed this phase.
626593|NCT00456014|O1|Outcome|1 - SSRI|Participants will take escitalopram.
626594|NCT00456014|E1|Reported Event|1 - SSRI|Participants will take escitalopram.
626595|NCT00455975|B3|Baseline|Total|Total of all reporting groups
626596|NCT00455975|B2|Baseline|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626597|NCT00455975|B1|Baseline|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626598|NCT00455975|P2|Participant Flow|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626599|NCT00455975|P1|Participant Flow|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626602|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626603|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626604|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626605|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626606|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626607|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626608|NCT00455975|E2|Reported Event|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626609|NCT00455975|E1|Reported Event|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
626610|NCT00455962|B3|Baseline|Total|Total of all reporting groups
626611|NCT00455962|B2|Baseline|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626612|NCT00455962|B1|Baseline|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626613|NCT00455962|P2|Participant Flow|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626614|NCT00455962|P1|Participant Flow|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626615|NCT00455962|O2|Outcome|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626616|NCT00455962|O1|Outcome|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626617|NCT00455962|E2|Reported Event|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626618|NCT00455962|E1|Reported Event|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
626619|NCT00455923|B3|Baseline|Total|Total of all reporting groups
626620|NCT00455923|B2|Baseline|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626621|NCT00455923|B1|Baseline|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626622|NCT00455923|P2|Participant Flow|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626623|NCT00455923|P1|Participant Flow|Seretide|Eligible participants received a starting dose of 50/100 micrograms (mcg) Seretide (combination of salmeterol/fluticasone propionate (Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626624|NCT00455923|O2|Outcome|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626625|NCT00455923|O1|Outcome|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626766|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626626|NCT00455923|O2|Outcome|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626627|NCT00455923|O1|Outcome|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626628|NCT00455923|O2|Outcome|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626629|NCT00455923|O1|Outcome|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626630|NCT00455923|O2|Outcome|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626631|NCT00455923|O1|Outcome|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626632|NCT00455923|O2|Outcome|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626633|NCT00455923|O1|Outcome|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626634|NCT00455923|O2|Outcome|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626635|NCT00455923|O1|Outcome|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626636|NCT00455923|E2|Reported Event|Flixotide|Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626637|NCT00455923|E1|Reported Event|Seretide|Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
626638|NCT00455858|B1|Baseline|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626639|NCT00455858|P1|Participant Flow|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626640|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626641|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626642|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626643|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626644|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626767|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626645|NCT00455858|E1|Reported Event|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
626646|NCT00455741|B3|Baseline|Total|Total of all reporting groups
626647|NCT00455741|B2|Baseline|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626648|NCT00455741|B1|Baseline|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626649|NCT00455741|P2|Participant Flow|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626650|NCT00455741|P1|Participant Flow|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626651|NCT00455741|O2|Outcome|Hypothalamus 72 hr|18 FDG uptake at the pituitary at 72 hr associated with estrogen induced positive feedback on LH
626652|NCT00455741|O1|Outcome|Hypothalamus at 24 hr|18 FDG uptake at the hypothalamus at 24 hr
626653|NCT00455741|O2|Outcome|Pituitary at 72 hr|18 FDG uptake at the pituitary at 72 hr associated with estrogen induced positive feedback on LH
626654|NCT00455741|O1|Outcome|Pituitary at 24 hr|18 FDG uptake at the pituitary at 24 hr
626655|NCT00455741|O2|Outcome|Negative Feedback Hypothalamus|18 FDG uptake at the at the hypothalamus at 24 hr associated with estrogen induced negative feedback on LH
626656|NCT00455741|O1|Outcome|Baseline Hypothalamus|18 FDG uptake at the hypothalamus at baseline
626657|NCT00455741|O2|Outcome|Negative Feedback Pituitary|18 FDG uptake at the pituitary at 24 hr associated with estrogen induced negative feedback on LH
626658|NCT00455741|O1|Outcome|Baseline Pituitary|18 FDG uptake at the pituitary at baseline
626659|NCT00455741|O2|Outcome|Older Postmenopausal Women|"Graded estradiol infusion to young postmenopausal women. Graded progesterone infusion to young postmenopausal women..~Estradiol infusion: Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626660|NCT00455741|O1|Outcome|Young Postmenopausal Women|"Graded estradiol infusion to young postmenopausal women. Graded progesterone infusion to young postmenopausal women.~Estradiol infusion: Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626661|NCT00455741|O2|Outcome|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626662|NCT00455741|O1|Outcome|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626663|NCT00455741|E2|Reported Event|Older PMW|"Postmenopausal women (PMW) ages 70-80 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626664|NCT00455741|E1|Reported Event|Younger PMW|"Postmenopausal women (PMW) ages 45-55 receiving the following hormone infusions.~Estradiol infusion:~Graded estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr, and 0.2 mcg/kg/hr for 60 hr.~Progesterone infusion:~Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr of the 5-day study."
626665|NCT00455702|B3|Baseline|Total|Total of all reporting groups
626666|NCT00455702|B2|Baseline|Placebo|50 mg placebo
626667|NCT00455702|B1|Baseline|D-cycloserine|50 mg d-cycloserine
626668|NCT00455702|P2|Participant Flow|Placebo|50 mg placebo
626669|NCT00455702|P1|Participant Flow|D-cycloserine|50 mg d-cycloserine
626670|NCT00455702|O2|Outcome|Placebo|"50 mg placebo~d-cycloserine: 50mg dose d-cycloserine v placebo"
626671|NCT00455702|O1|Outcome|D-cycloserine|"50 mg d-cycloserine~d-cycloserine: 50mg dose d-cycloserine v placebo"
626672|NCT00455702|O2|Outcome|Placebo|50 mg placebo
626673|NCT00455702|O1|Outcome|D-cycloserine|50 mg d-cycloserine
626674|NCT00455702|E2|Reported Event|Placebo|50 mg placebo
626675|NCT00455702|E1|Reported Event|D-cycloserine|50 mg d-cycloserine
626676|NCT00455663|B4|Baseline|Total|Total of all reporting groups
626677|NCT00455663|B3|Baseline|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
626678|NCT00455663|B2|Baseline|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
626679|NCT00455663|B1|Baseline|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
626680|NCT00455663|P3|Participant Flow|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
626681|NCT00455663|P2|Participant Flow|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
626682|NCT00455663|P1|Participant Flow|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
626683|NCT00455663|O3|Outcome|Treatment as Usual|Medication management and case management at a community mental health center
626684|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
626685|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
626686|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
626687|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
626688|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
626689|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
626690|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
626691|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
626692|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management in the community mental health center
626693|NCT00455663|O2|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
626694|NCT00455663|O1|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports to assist in medication and appointment adherence
626695|NCT00455663|E3|Reported Event|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
626696|NCT00455663|E2|Reported Event|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
626697|NCT00455663|E1|Reported Event|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
626698|NCT00455650|B3|Baseline|Total|Total of all reporting groups
626699|NCT00455650|B2|Baseline|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
626700|NCT00455650|B1|Baseline|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
626701|NCT00455650|P6|Participant Flow|Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626702|NCT00455650|P5|Participant Flow|Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626703|NCT00455650|P4|Participant Flow|Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626704|NCT00455650|P3|Participant Flow|Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626705|NCT00455650|P2|Participant Flow|Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626706|NCT00455650|P1|Participant Flow|Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626707|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626768|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626769|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626708|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626709|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626710|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626711|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626712|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626713|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626714|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626715|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626716|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626717|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626718|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626719|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626720|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626721|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626722|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626723|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626724|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626725|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626770|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626726|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626727|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626728|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
626729|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626730|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
626731|NCT00455650|E2|Reported Event|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
626732|NCT00455650|E1|Reported Event|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
626733|NCT00455533|B3|Baseline|Total|Total of all reporting groups
626734|NCT00455533|B2|Baseline|Paclitaxel (Randomized Population)|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626735|NCT00455533|B1|Baseline|Ixabepilone (Randomized Population)|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626736|NCT00455533|P3|Participant Flow|Paclitaxel|Paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626737|NCT00455533|P2|Participant Flow|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626738|NCT00455533|P1|Participant Flow|Doxorubicin / Cyclophosphamide (AC)|60 mg/m^2 doxorubicin and 600 mg/m^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).
626739|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626740|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626741|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626742|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626743|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626744|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626745|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626746|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626747|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626748|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626749|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626750|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626751|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626752|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626753|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626754|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626755|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626756|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626757|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626758|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626759|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626760|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626761|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626762|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626763|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626764|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626765|NCT00455533|O1|Outcome|Randomized Participants|Randomized Participants with non-missing pCR and biomarker expression
626771|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626772|NCT00455533|O1|Outcome|Randomized Participants|
626773|NCT00455533|O1|Outcome|Randomized Participants|
626774|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626775|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626776|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626777|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626778|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626779|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626780|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626781|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626782|NCT00455533|E2|Reported Event|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
626783|NCT00455533|E1|Reported Event|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
626784|NCT00455520|B3|Baseline|Total|Total of all reporting groups
626785|NCT00455520|B2|Baseline|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626786|NCT00455520|B1|Baseline|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626787|NCT00455520|P2|Participant Flow|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626788|NCT00455520|P1|Participant Flow|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626789|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626790|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626791|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626792|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626793|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626794|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626795|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626796|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626797|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626798|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626799|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626800|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626801|NCT00455520|E2|Reported Event|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
626802|NCT00455520|E1|Reported Event|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
626803|NCT00455455|B1|Baseline|Entire Study Group|includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period.
626804|NCT00455455|P2|Participant Flow|ReNu First, Then RepleniSH|Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
626805|NCT00455455|P1|Participant Flow|RepleniSH First, Then ReNu|Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)
626806|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in the first period or the second period
626807|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in the first period and the second period
626808|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
626809|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
626810|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
626811|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
626812|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
626813|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
626814|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
626815|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
626816|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
626817|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
626818|NCT00455455|E2|Reported Event|ReNu|use ReNu for lens care in either first period or second period
626819|NCT00455455|E1|Reported Event|RepleniSH|use RepleniSH for lens care in either first period or second period
626821|NCT00455429|B4|Baseline|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626822|NCT00455429|B3|Baseline|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626823|NCT00455429|B2|Baseline|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626824|NCT00455429|B1|Baseline|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626825|NCT00455429|P4|Participant Flow|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626826|NCT00455429|P3|Participant Flow|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626827|NCT00455429|P2|Participant Flow|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626828|NCT00455429|P1|Participant Flow|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626829|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626830|NCT00455429|O2|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626831|NCT00455429|O1|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626832|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626833|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626834|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626835|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626836|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626837|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626838|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626839|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626840|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626841|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626842|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626843|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626844|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626845|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626846|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626847|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626848|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626849|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626850|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626851|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626852|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626853|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626854|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626855|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626856|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626857|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626858|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626859|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626860|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626861|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626862|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626863|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626864|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626865|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626866|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626867|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626868|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626869|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626870|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626871|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626872|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626873|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626874|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626875|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626876|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626877|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626878|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626879|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626880|NCT00455429|E4|Reported Event|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
626881|NCT00455429|E3|Reported Event|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
626882|NCT00455429|E2|Reported Event|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
626883|NCT00455429|E1|Reported Event|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
626884|NCT00455312|B3|Baseline|Total|Total of all reporting groups
626885|NCT00455312|B2|Baseline|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626886|NCT00455312|B1|Baseline|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626887|NCT00455312|P2|Participant Flow|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin (ATG), total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626888|NCT00455312|P1|Participant Flow|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626889|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626890|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626946|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626891|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626892|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626893|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626894|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626895|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626896|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626897|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626898|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626899|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626930|NCT00455013|B2|Baseline|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626900|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626901|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626902|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626903|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626904|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626905|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626906|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626907|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626908|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626931|NCT00455013|B1|Baseline|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
627094|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
626909|NCT00455312|E2|Reported Event|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
626910|NCT00455312|E1|Reported Event|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
626911|NCT00455195|B3|Baseline|Total|Total of all reporting groups
626912|NCT00455195|B2|Baseline|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
626913|NCT00455195|B1|Baseline|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626914|NCT00455195|P2|Participant Flow|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
626915|NCT00455195|P1|Participant Flow|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626916|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626917|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626918|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626919|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626920|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626921|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626922|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626923|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626924|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626925|NCT00455195|E3|Reported Event|Overall|The combined alglucosidase alfa treatment experience from the two treatment groups.
626926|NCT00455195|E2|Reported Event|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
626927|NCT00455195|E1|Reported Event|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
626928|NCT00455013|B4|Baseline|Total|Total of all reporting groups
626929|NCT00455013|B3|Baseline|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626932|NCT00455013|P3|Participant Flow|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg.
626933|NCT00455013|P2|Participant Flow|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg.
626934|NCT00455013|P1|Participant Flow|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg.
626935|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626936|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626937|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626938|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626939|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626940|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626941|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626942|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626943|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626944|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626945|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
627133|NCT00454857|E1|Reported Event|Overall Study|
626947|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626948|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626949|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626950|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626951|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626952|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626953|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626954|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626955|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626956|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626957|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626958|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626959|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626960|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626961|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
627016|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
626962|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626963|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626964|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626965|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626966|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626967|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626968|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626969|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626970|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626971|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626972|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626973|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626974|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626975|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626976|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
627017|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
626977|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626978|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626979|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626980|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626981|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626982|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626983|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626984|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626985|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626986|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626987|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626988|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626989|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626990|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626991|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
627018|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
626992|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
626993|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
626994|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
626995|NCT00455013|E3|Reported Event|Tacrolimus - MMF|
626996|NCT00455013|E2|Reported Event|Belatacept - SIRO|
626997|NCT00455013|E1|Reported Event|Belatacept - MMF|
626998|NCT00454987|B4|Baseline|Total|Total of all reporting groups
626999|NCT00454987|B3|Baseline|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627000|NCT00454987|B2|Baseline|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627001|NCT00454987|B1|Baseline|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627002|NCT00454987|P3|Participant Flow|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627003|NCT00454987|P2|Participant Flow|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627004|NCT00454987|P1|Participant Flow|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627005|NCT00454987|O3|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627006|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627007|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627008|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627009|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627010|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627011|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627012|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627013|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627014|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627015|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627134|NCT00454818|B9|Baseline|Total|Total of all reporting groups
629001|NCT00450450|B2|Baseline|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
627019|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627020|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627021|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627022|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627023|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627024|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627025|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627026|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627027|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627028|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627029|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627030|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627031|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627032|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627033|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627034|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627035|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627036|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627037|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627038|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627039|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627040|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627041|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627135|NCT00454818|B8|Baseline|Phase 2: Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627042|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627043|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627044|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627045|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627046|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627047|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627048|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627049|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627050|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627051|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627052|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627053|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627054|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627055|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627056|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627057|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627058|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627059|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627060|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627061|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627062|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627063|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627064|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627065|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627066|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627067|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627068|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627069|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627070|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627071|NCT00454987|E3|Reported Event|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627072|NCT00454987|E2|Reported Event|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627073|NCT00454987|E1|Reported Event|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
627074|NCT00454909|B4|Baseline|Total|Total of all reporting groups
627075|NCT00454909|B3|Baseline|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627076|NCT00454909|B2|Baseline|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627077|NCT00454909|B1|Baseline|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627078|NCT00454909|P3|Participant Flow|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627079|NCT00454909|P2|Participant Flow|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627080|NCT00454909|P1|Participant Flow|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627081|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627082|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627083|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627084|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627085|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627086|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627087|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627088|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627089|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627090|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627091|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627092|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627093|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
629002|NCT00450450|B1|Baseline|Control BM Arm|Conventional bone marrow transplant (BM)
627095|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627096|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627097|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627098|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627099|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627100|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627101|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627102|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627103|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627104|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627105|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627106|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627107|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627108|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627109|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627110|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627111|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627112|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627113|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627114|NCT00454909|E3|Reported Event|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627115|NCT00454909|E2|Reported Event|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627116|NCT00454909|E1|Reported Event|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
627117|NCT00454857|B1|Baseline|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627118|NCT00454857|P1|Participant Flow|Patients With ITP|Patients diagnosed with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) were followed prospectively for a period of 12 months.
627119|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627120|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627121|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627122|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627123|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627124|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627125|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627126|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627127|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627128|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627129|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627130|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627131|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627132|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
627136|NCT00454818|B7|Baseline|Phase 2: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627137|NCT00454818|B6|Baseline|Phase 2: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627138|NCT00454818|B5|Baseline|Phase 2: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627139|NCT00454818|B4|Baseline|Phase 1: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627140|NCT00454818|B3|Baseline|Phase 1: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627141|NCT00454818|B2|Baseline|Phase 1: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627142|NCT00454818|B1|Baseline|Phase 1: MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
627143|NCT00454818|P5|Participant Flow|Placebo|"Single dose of placebo administered by antegrade epicardial coronary artery infusion.~The placebo arm was included only in the Phase 2 randomized double-blind period."
627144|NCT00454818|P4|Participant Flow|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
627145|NCT00454818|P3|Participant Flow|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
627146|NCT00454818|P2|Participant Flow|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
627147|NCT00454818|P1|Participant Flow|MYDICAR® Very Low Dose|"Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.~This arm was included only in the Phase I open-label dose-escalation period."
627148|NCT00454818|O6|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627149|NCT00454818|O5|Outcome|All MYDICAR®|All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.
627150|NCT00454818|O4|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627151|NCT00454818|O3|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627152|NCT00454818|O2|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627153|NCT00454818|O1|Outcome|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
627154|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627155|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627156|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627157|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627158|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627159|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627160|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627460|NCT00454584|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
627161|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627162|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627163|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627164|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627165|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627166|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627167|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627168|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627169|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627170|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627171|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627172|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627173|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627174|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627175|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627176|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627177|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627178|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627179|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627180|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627181|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627182|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627183|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627184|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627185|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627186|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627187|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627461|NCT00454584|P1|Participant Flow|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
629005|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
627188|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627189|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627190|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627191|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627192|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627193|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627194|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627195|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627196|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627197|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627198|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627199|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627200|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627201|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627202|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627203|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627204|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627205|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627206|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627207|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627208|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627209|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627210|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627211|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627212|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627213|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627214|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627487|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
627215|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627216|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627217|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
627218|NCT00454818|E5|Reported Event|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
627219|NCT00454818|E4|Reported Event|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
627220|NCT00454818|E3|Reported Event|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
627221|NCT00454818|E2|Reported Event|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.
627222|NCT00454818|E1|Reported Event|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.
627223|NCT00454805|B3|Baseline|Total|Total of all reporting groups
627224|NCT00454805|B2|Baseline|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
627225|NCT00454805|B1|Baseline|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627226|NCT00454805|P2|Participant Flow|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
627227|NCT00454805|P1|Participant Flow|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627228|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
627229|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627230|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
627231|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627232|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
627233|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627234|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
627235|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627236|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
628137|NCT00452699|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
627237|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627238|NCT00454805|E2|Reported Event|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
627239|NCT00454805|E1|Reported Event|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
627240|NCT00454779|B3|Baseline|Total|Total of all reporting groups
627241|NCT00454779|B2|Baseline|Chemotherapy Alone|Docetaxel + Cisplatin, control
627242|NCT00454779|B1|Baseline|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627243|NCT00454779|P2|Participant Flow|Chemotherapy Alone|Docetaxel + Cisplatin, control
627244|NCT00454779|P1|Participant Flow|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627245|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627246|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627247|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627248|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627249|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627250|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627251|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627252|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627253|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627254|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627255|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627256|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627257|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627258|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627259|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627260|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627261|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627262|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627263|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627264|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627265|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627266|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627267|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
627268|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627269|NCT00454779|E2|Reported Event|Chemotherapy Alone|Docetaxel + Cisplatin, control
627270|NCT00454779|E1|Reported Event|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
627271|NCT00454649|B11|Baseline|Total|Total of all reporting groups
627272|NCT00454649|B10|Baseline|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627273|NCT00454649|B9|Baseline|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627274|NCT00454649|B8|Baseline|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627275|NCT00454649|B7|Baseline|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627276|NCT00454649|B6|Baseline|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627277|NCT00454649|B5|Baseline|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627278|NCT00454649|B4|Baseline|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627279|NCT00454649|B3|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627280|NCT00454649|B2|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627281|NCT00454649|B1|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627282|NCT00454649|P10|Participant Flow|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627283|NCT00454649|P9|Participant Flow|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627284|NCT00454649|P8|Participant Flow|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627285|NCT00454649|P7|Participant Flow|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627286|NCT00454649|P6|Participant Flow|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627287|NCT00454649|P5|Participant Flow|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627288|NCT00454649|P4|Participant Flow|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627289|NCT00454649|P3|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627290|NCT00454649|P2|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627291|NCT00454649|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627292|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627293|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 18 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627294|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627295|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627296|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627297|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627298|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627299|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627300|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/meter square (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627301|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627302|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627303|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627304|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627305|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627306|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627307|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627308|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627309|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627310|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627311|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627312|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627313|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
628299|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
627314|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627315|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627316|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627317|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627318|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627319|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627320|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627321|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627322|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627323|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627324|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627325|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627326|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627327|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627328|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627329|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627330|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627331|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627332|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627333|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627334|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627335|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627336|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627682|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627337|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627338|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627339|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627340|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627341|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627342|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627343|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627344|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627345|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627346|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627347|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627348|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627349|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
627350|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627351|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627352|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627353|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627354|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627355|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627356|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627357|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627358|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627683|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
646267|NCT00410761|O2|Outcome|Placebo|Placebo daily
627359|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627360|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627361|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627362|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627363|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627364|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627365|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627366|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627367|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627368|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627369|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627370|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627371|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627372|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627373|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627374|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627375|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627432|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
629006|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
627376|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627377|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627378|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627379|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627380|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627381|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627382|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627383|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627384|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627385|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627386|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627387|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 administered as infusion on Day 1 Cycle 1 and all subsequent cycles.
627388|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval. Cisplatin 80 mg/m^2 administered as infusion on Day 1 of Cycle 1 and all subsequent cycles. Gemcitabine 1250 mg/m^2 administered as infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles.
627389|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1250 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
627390|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1000 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
627391|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1. AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Docetaxel 100 mg/m^2 administered as 60-minute infusion on Day 1 of every cycle.
627392|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 25 of Cycle 1 (cycle length 28 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel 90 mg/m^2 administered as 60-minute infusion on Day 1, 8, and 15 of every cycle.
646268|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
627393|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
627394|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|AG-013736 3 oral tablets of 1 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
627395|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) oral tablet of 1 mg (milligram) administered twice daily (BID) as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
627396|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627397|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627398|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627399|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627400|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627401|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627402|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627403|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627404|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627405|NCT00454649|E10|Reported Event|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
627406|NCT00454649|E9|Reported Event|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
627407|NCT00454649|E8|Reported Event|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627408|NCT00454649|E7|Reported Event|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
627409|NCT00454649|E6|Reported Event|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
627410|NCT00454649|E5|Reported Event|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627411|NCT00454649|E4|Reported Event|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
627412|NCT00454649|E3|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627413|NCT00454649|E2|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
627414|NCT00454649|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
627415|NCT00454636|B5|Baseline|Total|Total of all reporting groups
627416|NCT00454636|B4|Baseline|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627417|NCT00454636|B3|Baseline|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627418|NCT00454636|B2|Baseline|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627419|NCT00454636|B1|Baseline|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627420|NCT00454636|P4|Participant Flow|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627421|NCT00454636|P3|Participant Flow|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627422|NCT00454636|P2|Participant Flow|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627423|NCT00454636|P1|Participant Flow|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627424|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627425|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627426|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627427|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627428|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627429|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627430|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627431|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627459|NCT00454584|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
646269|NCT00410761|O2|Outcome|Placebo|Placebo daily
627433|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627434|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627435|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627436|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627437|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627438|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627439|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627440|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627441|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627442|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627443|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627444|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627445|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627446|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627447|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627448|NCT00454636|E4|Reported Event|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
627449|NCT00454636|E3|Reported Event|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627450|NCT00454636|E2|Reported Event|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
627451|NCT00454636|E1|Reported Event|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
627452|NCT00454584|B4|Baseline|Total|Total of all reporting groups
627453|NCT00454584|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627454|NCT00454584|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627455|NCT00454584|B1|Baseline|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627456|NCT00454584|P6|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
627457|NCT00454584|P5|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
627458|NCT00454584|P4|Participant Flow|Etanercept (After CP)|After Controlled period (Week 12- 64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40
627462|NCT00454584|O2|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627463|NCT00454584|O1|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627464|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627465|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627466|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627467|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627468|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627469|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627470|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627471|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627472|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
627473|NCT00454584|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
627474|NCT00454584|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
627475|NCT00454584|E5|Reported Event|Etanercept -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg upon becoming a nonresponder during Week 12 and Week 40. This group is a subpopulation of Etanercept (after CP).
627476|NCT00454584|E4|Reported Event|Etanercept (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> prior to being treated with ustekinumab
627477|NCT00454584|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
627478|NCT00454584|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
627479|NCT00454584|E1|Reported Event|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
627480|NCT00454571|B3|Baseline|Total|Total of all reporting groups
627481|NCT00454571|B2|Baseline|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
627482|NCT00454571|B1|Baseline|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
627483|NCT00454571|P2|Participant Flow|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
627484|NCT00454571|P1|Participant Flow|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
627485|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
627486|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
627488|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
627489|NCT00454571|E2|Reported Event|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
627490|NCT00454571|E1|Reported Event|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
627491|NCT00454532|B5|Baseline|Total|Total of all reporting groups
627492|NCT00454532|B4|Baseline|Level 4|40g/day
627493|NCT00454532|B3|Baseline|Level 3|30g/day
627494|NCT00454532|B2|Baseline|Level 2|20g/day
627495|NCT00454532|B1|Baseline|Level 1|10g/day
627496|NCT00454532|P4|Participant Flow|Level 4|40g/day
627497|NCT00454532|P3|Participant Flow|Level 3|30g/day
627498|NCT00454532|P2|Participant Flow|Level 2|20g/day
627499|NCT00454532|P1|Participant Flow|Level 1|10g/day
627500|NCT00454532|O4|Outcome|Level 4|40g/day
627501|NCT00454532|O3|Outcome|Level 3|30g/day
627502|NCT00454532|O2|Outcome|Level 2|20g/day
627503|NCT00454532|O1|Outcome|Level 1|10g/day
627504|NCT00454532|O4|Outcome|Level 4|40g/day
627505|NCT00454532|O3|Outcome|Level 3|30g/day
627506|NCT00454532|O2|Outcome|Level 2|20g/day
627507|NCT00454532|O1|Outcome|Level 1|10g/day
627508|NCT00454532|O4|Outcome|Level 4|40g/day
627509|NCT00454532|O3|Outcome|Level 3|30g/day
627510|NCT00454532|O2|Outcome|Level 2|20g/day
627511|NCT00454532|O1|Outcome|Level 1|10g/day
627512|NCT00454532|E4|Reported Event|Level 4|40g/day
627513|NCT00454532|E3|Reported Event|Level 3|30g/day
627514|NCT00454532|E2|Reported Event|Level 2|20g/day
627515|NCT00454532|E1|Reported Event|Level 1|10g/day
627516|NCT00454363|B3|Baseline|Total|Total of all reporting groups
627517|NCT00454363|B2|Baseline|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627518|NCT00454363|B1|Baseline|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627519|NCT00454363|P2|Participant Flow|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627520|NCT00454363|P1|Participant Flow|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627521|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627522|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627523|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627524|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
627525|NCT00454363|E1|Reported Event|Pazopanib|Oral pazopanib hydrochloride once daily on days 1-28.
627526|NCT00454324|B3|Baseline|Total|Total of all reporting groups
627527|NCT00454324|B2|Baseline|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627528|NCT00454324|B1|Baseline|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627529|NCT00454324|P2|Participant Flow|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627530|NCT00454324|P1|Participant Flow|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of Area Under the Curve (AUC)=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627531|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627532|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627533|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627534|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627535|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627536|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627537|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627538|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627539|NCT00454324|E2|Reported Event|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627540|NCT00454324|E1|Reported Event|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
627541|NCT00454246|B4|Baseline|Total|Total of all reporting groups
627542|NCT00454246|B3|Baseline|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627543|NCT00454246|B2|Baseline|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627544|NCT00454246|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627545|NCT00454246|P3|Participant Flow|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627546|NCT00454246|P2|Participant Flow|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627547|NCT00454246|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627548|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627549|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627550|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627551|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627552|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627553|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
628300|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
627554|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627555|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627556|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627557|NCT00454246|E3|Reported Event|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627558|NCT00454246|E2|Reported Event|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627559|NCT00454246|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
627560|NCT00454207|B3|Baseline|Total|Total of all reporting groups
627561|NCT00454207|B2|Baseline|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
627562|NCT00454207|B1|Baseline|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627563|NCT00454207|P2|Participant Flow|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
627564|NCT00454207|P1|Participant Flow|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627565|NCT00454207|O1|Outcome|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
627566|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627567|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627568|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627569|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627644|NCT00454142|B1|Baseline|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
646270|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
627570|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627571|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627572|NCT00454207|O1|Outcome|Sildenafil: Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627573|NCT00454207|O4|Outcome|Sildenafil: Part II, Functional Class at Baseline: IV|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were IV. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627574|NCT00454207|O3|Outcome|Sildenafil: Part II, Functional Class at Baseline: III|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were III. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627575|NCT00454207|O2|Outcome|Sildenafil:Part II, Functional Class at Baseline: II|Consists of participants who newly entered the study from Part II period in Week 0, and whose who functional class at baseline were II. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627576|NCT00454207|O1|Outcome|Sildenafil:Part II, Functional Class at Baseline: I|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were I. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627577|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627578|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627579|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627580|NCT00454207|O4|Outcome|Sildenafil, Part I, Functional Class at Baseline:IV|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627581|NCT00454207|O3|Outcome|Sildenafil, Part I, Functional Class at Baseline: III|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627582|NCT00454207|O2|Outcome|Sildenafil:Part I, Functional Class at Baseline: II|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627583|NCT00454207|O1|Outcome|Sildenafil:Part I , Functional Class at Baseline: I|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were I. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627679|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
646271|NCT00410761|O2|Outcome|Placebo|Placebo daily
627584|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627585|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627586|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627587|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627588|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627589|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627590|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627591|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627592|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627593|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627594|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627595|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627596|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627597|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627598|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627599|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627600|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627680|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627601|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627602|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627603|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627604|NCT00454207|O1|Outcome|Sildenafil: Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
627605|NCT00454207|E1|Reported Event|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
627606|NCT00454194|B3|Baseline|Total|Total of all reporting groups
627607|NCT00454194|B2|Baseline|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627608|NCT00454194|B1|Baseline|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627609|NCT00454194|P2|Participant Flow|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627610|NCT00454194|P1|Participant Flow|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627611|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627612|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627613|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627614|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627615|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627616|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627617|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627618|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627619|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627620|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627621|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627622|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627623|NCT00454194|E2|Reported Event|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
627624|NCT00454194|E1|Reported Event|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
627625|NCT00454181|B3|Baseline|Total|Total of all reporting groups
627626|NCT00454181|B2|Baseline|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627627|NCT00454181|B1|Baseline|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627628|NCT00454181|P2|Participant Flow|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627629|NCT00454181|P1|Participant Flow|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627630|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627631|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627632|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627633|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627634|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627635|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627636|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627637|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627638|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627639|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627640|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627641|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627642|NCT00454181|E2|Reported Event|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
627643|NCT00454181|E1|Reported Event|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
627681|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
628301|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
627645|NCT00454142|P1|Participant Flow|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
627646|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627647|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627648|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627649|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627650|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627651|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627652|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627653|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
627654|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627655|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
627656|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
627657|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
627658|NCT00454142|E1|Reported Event|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
627659|NCT00454116|B4|Baseline|Total|Total of all reporting groups
627660|NCT00454116|B3|Baseline|Placebo Plus FOLFIRI|placebo plus FOLFIRI
627661|NCT00454116|B2|Baseline|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
627662|NCT00454116|B1|Baseline|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
627663|NCT00454116|P3|Participant Flow|Placebo Plus FOLFIRI|placebo plus FOLFIRI
627664|NCT00454116|P2|Participant Flow|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
627665|NCT00454116|P1|Participant Flow|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
627666|NCT00454116|O3|Outcome|Placebo Plus FOLFIRI|placebo plus FOLFIRI
627667|NCT00454116|O2|Outcome|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
627668|NCT00454116|O1|Outcome|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
627669|NCT00454116|E3|Reported Event|Placebo Plus FOLFIRI|placebo plus FOLFIRI
627670|NCT00454116|E2|Reported Event|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
627671|NCT00454116|E1|Reported Event|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
627672|NCT00454051|B3|Baseline|Total|Total of all reporting groups
627673|NCT00454051|B2|Baseline|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627674|NCT00454051|B1|Baseline|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627675|NCT00454051|P2|Participant Flow|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627676|NCT00454051|P1|Participant Flow|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627677|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627678|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627684|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627685|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627686|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627687|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627688|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627689|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627690|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627691|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627692|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627693|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627694|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627695|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627696|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627697|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627698|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627699|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627700|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627701|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627702|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627703|NCT00454051|E2|Reported Event|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
627704|NCT00454051|E1|Reported Event|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
627705|NCT00453999|B4|Baseline|Total|Total of all reporting groups
627706|NCT00453999|B3|Baseline|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627707|NCT00453999|B2|Baseline|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627708|NCT00453999|B1|Baseline|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627709|NCT00453999|P3|Participant Flow|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627710|NCT00453999|P2|Participant Flow|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627711|NCT00453999|P1|Participant Flow|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627712|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627713|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627714|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627715|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627716|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627717|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627718|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627719|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627720|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627721|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627722|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
646272|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
627723|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627724|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627725|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627726|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627727|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627728|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627729|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627730|NCT00453999|E3|Reported Event|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
627731|NCT00453999|E2|Reported Event|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
627732|NCT00453999|E1|Reported Event|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
627733|NCT00453986|B6|Baseline|Total|Total of all reporting groups
627734|NCT00453986|B5|Baseline|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627735|NCT00453986|B4|Baseline|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627736|NCT00453986|B3|Baseline|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627737|NCT00453986|B2|Baseline|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627738|NCT00453986|B1|Baseline|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627739|NCT00453986|P5|Participant Flow|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627740|NCT00453986|P4|Participant Flow|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627741|NCT00453986|P3|Participant Flow|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627742|NCT00453986|P2|Participant Flow|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627743|NCT00453986|P1|Participant Flow|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627744|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627745|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Group Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627746|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627747|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627748|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627749|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627750|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627751|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627752|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627753|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627754|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627755|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627756|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627757|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627758|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627759|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627760|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627761|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627762|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627763|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627764|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627765|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627766|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627767|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627768|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627769|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627770|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627771|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627772|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627773|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627774|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627775|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627776|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627777|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627778|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627779|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627780|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627781|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627782|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627783|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627784|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627785|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627786|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627787|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627788|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627789|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627790|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627791|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627792|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627793|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627794|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627795|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627796|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627797|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627798|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627799|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627800|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627801|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627802|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627803|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627804|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627805|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627806|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627807|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
628302|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
627808|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627809|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627810|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627811|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627812|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627813|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627814|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627815|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627816|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627817|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627818|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627819|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627820|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627821|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627822|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627823|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627824|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627825|NCT00453986|O2|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of Fluarix vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627826|NCT00453986|O1|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627827|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627828|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627829|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627830|NCT00453986|E5|Reported Event|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
627831|NCT00453986|E4|Reported Event|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627832|NCT00453986|E3|Reported Event|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
627833|NCT00453986|E2|Reported Event|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
628138|NCT00452699|E1|Reported Event|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
627834|NCT00453986|E1|Reported Event|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
627835|NCT00453973|B3|Baseline|Pooled AF37702 Inj.|
627836|NCT00453973|B2|Baseline|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
627837|NCT00453973|B1|Baseline|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
627838|NCT00453973|P2|Participant Flow|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
627839|NCT00453973|P1|Participant Flow|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
627840|NCT00453973|O2|Outcome|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
627841|NCT00453973|O1|Outcome|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
627842|NCT00453973|E2|Reported Event|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
627843|NCT00453973|E1|Reported Event|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
627844|NCT00453479|B4|Baseline|Total|Total of all reporting groups
627845|NCT00453479|B3|Baseline|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627846|NCT00453479|B2|Baseline|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627847|NCT00453479|B1|Baseline|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627848|NCT00453479|P3|Participant Flow|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627849|NCT00453479|P2|Participant Flow|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 micrograms (µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627850|NCT00453479|P1|Participant Flow|Placebo|Participants entered into Cohort I received single inhaled dose of dry powder inhaler (DPI) of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) and was formulated with lactose only as a vehicle to make 12.5 milligrams (mg).
627851|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
628139|NCT00452673|B5|Baseline|Total|Total of all reporting groups
627852|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627853|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627854|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627855|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627856|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627857|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627858|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627859|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627860|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627861|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627862|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627863|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627864|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627865|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627866|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627867|NCT00453479|O2|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627868|NCT00453479|O1|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627869|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627870|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627871|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627872|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
628204|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
627873|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627874|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627875|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627876|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627877|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627878|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627879|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627880|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627881|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627882|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627883|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627884|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627885|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627886|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627887|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627888|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627889|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627890|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627891|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627892|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
628205|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
646273|NCT00410761|O2|Outcome|Placebo|Placebo daily
627893|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627894|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627895|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627896|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627897|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627898|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627899|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627900|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627901|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627902|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627903|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627904|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627905|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627906|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627907|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627908|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627909|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627910|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627911|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627912|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
628206|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628303|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
627913|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627914|NCT00453479|O3|Outcome|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627915|NCT00453479|O2|Outcome|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627916|NCT00453479|O1|Outcome|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627917|NCT00453479|E3|Reported Event|GSK233705 100 µg Twice Daily|Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627918|NCT00453479|E2|Reported Event|GSK233705 50 µg Twice Daily|Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
627919|NCT00453479|E1|Reported Event|Placebo|Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
627920|NCT00453388|B5|Baseline|Total|Total of all reporting groups
627921|NCT00453388|B4|Baseline|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627922|NCT00453388|B3|Baseline|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627923|NCT00453388|B2|Baseline|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627924|NCT00453388|B1|Baseline|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627925|NCT00453388|P4|Participant Flow|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627956|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
628207|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
627926|NCT00453388|P3|Participant Flow|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627927|NCT00453388|P2|Participant Flow|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627928|NCT00453388|P1|Participant Flow|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627929|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627930|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627931|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627932|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627933|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627934|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
629007|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
627935|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627936|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627937|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627938|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627939|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627940|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627941|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627942|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627943|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
629008|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
627944|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627945|NCT00453388|E4|Reported Event|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627946|NCT00453388|E3|Reported Event|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627947|NCT00453388|E2|Reported Event|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627948|NCT00453388|E1|Reported Event|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
627949|NCT00453362|B1|Baseline|Erlotinib|Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
627950|NCT00453362|P1|Participant Flow|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-[18F]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-[18F]fluorothymidine-Positron Emission Tomogrpahy) scans.~FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi."
627951|NCT00453362|O1|Outcome|Overall Study Participants|"All Participants who underwent any FLT-PET scan during the study (including screening) were included in the analysis.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
627952|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
627953|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
627954|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
627955|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
628129|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
627957|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
627958|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
627959|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight no to exceed 15 mCi."
627960|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responder|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
627961|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
627962|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
627963|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
627964|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
627965|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
627966|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
627967|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
627968|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
627969|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi."
627970|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
627971|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
628130|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628131|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
627972|NCT00453362|E1|Reported Event|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi."
627973|NCT00453349|B3|Baseline|Total|Total of all reporting groups
627974|NCT00453349|B2|Baseline|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627975|NCT00453349|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627976|NCT00453349|P2|Participant Flow|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627977|NCT00453349|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627978|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627979|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627980|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627981|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627982|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627983|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627984|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627985|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627986|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627987|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627988|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627989|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627990|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627991|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627992|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627993|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627994|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627995|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627996|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627997|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
627998|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
627999|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
628000|NCT00453349|E2|Reported Event|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
628001|NCT00453349|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
628002|NCT00453336|B1|Baseline|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
628003|NCT00453336|P1|Participant Flow|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
628004|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
628005|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
628132|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628133|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628006|NCT00453336|E1|Reported Event|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
628007|NCT00453310|B1|Baseline|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
628008|NCT00453310|P1|Participant Flow|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
628009|NCT00453310|O1|Outcome|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
628010|NCT00453310|E1|Reported Event|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
628011|NCT00453206|B1|Baseline|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
628012|NCT00453206|P1|Participant Flow|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
628013|NCT00453206|O1|Outcome|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
628014|NCT00453206|E1|Reported Event|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
628015|NCT00453193|B1|Baseline|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
628016|NCT00453193|P1|Participant Flow|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
628017|NCT00453193|O1|Outcome|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
628018|NCT00453193|E1|Reported Event|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
628019|NCT00453180|B3|Baseline|Total|Total of all reporting groups
628020|NCT00453180|B2|Baseline|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628021|NCT00453180|B1|Baseline|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628022|NCT00453180|P2|Participant Flow|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628023|NCT00453180|P1|Participant Flow|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628024|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628025|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628026|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628027|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628028|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628029|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628030|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628031|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628032|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628033|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628034|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628035|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628036|NCT00453180|E2|Reported Event|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain in active ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
628037|NCT00453180|E1|Reported Event|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
628038|NCT00453154|B4|Baseline|Total|Total of all reporting groups
628039|NCT00453154|B3|Baseline|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
628040|NCT00453154|B2|Baseline|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628041|NCT00453154|B1|Baseline|Phase I|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628042|NCT00453154|P4|Participant Flow|Double Blind Sunitinib Maintenance|Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
628043|NCT00453154|P3|Participant Flow|Double Blind Placebo Maintenance With Optional Crossover|"Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.~At progression, participants receiving placebo could cross over to receive open label sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628044|NCT00453154|P2|Participant Flow|Phase II Combination Chemotherapy|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IVover 1 hour on days 1, 2, and 3 every cycle"
628045|NCT00453154|P1|Participant Flow|Phase 1B|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628046|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
628047|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628048|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
628134|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628135|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628049|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628050|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
628051|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628052|NCT00453154|O3|Outcome|Cohort 3|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 50 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628053|NCT00453154|O2|Outcome|Cohort 2|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 37.5 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628054|NCT00453154|O1|Outcome|Cohort 1|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
628055|NCT00453154|E2|Reported Event|Arm II (Combination Chemotherapy + Placebo Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
628056|NCT00453154|E1|Reported Event|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
628057|NCT00453102|B1|Baseline|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628058|NCT00453102|P1|Participant Flow|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628059|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628060|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628061|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628062|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628063|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628064|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628065|NCT00453102|E1|Reported Event|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
628066|NCT00453063|B3|Baseline|Total|Total of all reporting groups
628067|NCT00453063|B2|Baseline|Placebo|Two sprays in each nostril once daily
628068|NCT00453063|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628069|NCT00453063|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
628070|NCT00453063|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628071|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
628072|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628073|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
628074|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628075|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
628076|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628077|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
628078|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628079|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
628080|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628081|NCT00453063|E2|Reported Event|Placebo|Two sprays in each nostril once daily
628082|NCT00453063|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
628083|NCT00452868|B1|Baseline|Donepezil|
628084|NCT00452868|P1|Participant Flow|Donepezil|Patients less than 35 kilograms(kg): Donepezil 5 milligrams (mg) orally once every alternate day. Patients greater than 35 kg Donepezil 5 mg orally once per day. If there are no adverse effects noted on review of symptoms, the dose will be increased to 5 mg daily for patients < 35 kg. And to 10 mg/day for patients > 35 kg. This evaluation and dose escalation may be done as early as week 4. For all, donepezil will be administered 24 weeks.
628085|NCT00452868|O1|Outcome|Donepezil|
628086|NCT00452868|E1|Reported Event|Donepezil|
628087|NCT00452790|B3|Baseline|Total|Total of all reporting groups
628088|NCT00452790|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628089|NCT00452790|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628090|NCT00452790|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628091|NCT00452790|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628092|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628093|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628304|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628094|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628095|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628096|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628097|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628098|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628099|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628100|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628101|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628102|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628103|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628104|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628105|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628106|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628107|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628108|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628136|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628109|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628110|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628111|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628112|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628113|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628114|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628115|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628116|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628117|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628118|NCT00452790|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
628119|NCT00452790|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
628120|NCT00452790|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
628121|NCT00452790|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
628122|NCT00452790|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628123|NCT00452790|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
628124|NCT00452699|B3|Baseline|Total|Total of all reporting groups
628125|NCT00452699|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628126|NCT00452699|B1|Baseline|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628127|NCT00452699|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628128|NCT00452699|P1|Participant Flow|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628140|NCT00452673|B4|Baseline|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628141|NCT00452673|B3|Baseline|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628142|NCT00452673|B2|Baseline|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628143|NCT00452673|B1|Baseline|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628144|NCT00452673|P5|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion)|No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for the dose expansion period in order to provide additional information regarding good tolerance of extended treatment. An additional 21 participants were treated in this arm in the Dose Expansion Period.
628145|NCT00452673|P4|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628146|NCT00452673|P3|Participant Flow|70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628147|NCT00452673|P2|Participant Flow|70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628148|NCT00452673|P1|Participant Flow|50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628149|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628150|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628151|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628152|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628153|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628154|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628155|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628208|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628209|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
628210|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628211|NCT00452530|E2|Reported Event|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
628156|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628157|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628158|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628159|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628160|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628161|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628162|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628163|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628164|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628165|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628166|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628167|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628168|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628169|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628170|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628171|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628212|NCT00452530|E1|Reported Event|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628213|NCT00452452|B4|Baseline|Total|Total of all reporting groups
628172|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628173|NCT00452673|E4|Reported Event|100 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
628174|NCT00452673|E3|Reported Event|70 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
628175|NCT00452673|E2|Reported Event|70 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
628176|NCT00452673|E1|Reported Event|50 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
628177|NCT00452543|B3|Baseline|Total|Total of all reporting groups
628178|NCT00452543|B2|Baseline|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
628179|NCT00452543|B1|Baseline|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
628180|NCT00452543|P2|Participant Flow|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
628181|NCT00452543|P1|Participant Flow|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
628182|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
628183|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
628184|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
628185|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
628186|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
628187|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
628188|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
628189|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
628190|NCT00452543|E2|Reported Event|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
628191|NCT00452543|E1|Reported Event|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
628192|NCT00452530|B3|Baseline|Total|Total of all reporting groups
628193|NCT00452530|B2|Baseline|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
628194|NCT00452530|B1|Baseline|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628195|NCT00452530|P2|Participant Flow|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
628196|NCT00452530|P1|Participant Flow|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628197|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
628198|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
628199|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
628200|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628201|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
628202|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
628203|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
628296|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628214|NCT00452452|B3|Baseline|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
628215|NCT00452452|B2|Baseline|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
628216|NCT00452452|B1|Baseline|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
628217|NCT00452452|P3|Participant Flow|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
628218|NCT00452452|P2|Participant Flow|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
628219|NCT00452452|P1|Participant Flow|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
628220|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
628221|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
628222|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
628223|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
628224|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
628225|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
628226|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
628227|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
628228|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
628229|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
628230|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
628231|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
628232|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
628233|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
628234|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
628235|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
628236|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
628237|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
628238|NCT00452452|E3|Reported Event|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
628239|NCT00452452|E2|Reported Event|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
628297|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628298|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
646274|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
628240|NCT00452452|E1|Reported Event|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
628241|NCT00452426|B3|Baseline|Total|Total of all reporting groups
628242|NCT00452426|B2|Baseline|Current Standard of Care|Site's current standard used for delivery of sedation
628243|NCT00452426|B1|Baseline|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628244|NCT00452426|P2|Participant Flow|Current Standard of Care|Site's current standard used for delivery of sedation
628245|NCT00452426|P1|Participant Flow|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628246|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
628247|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628248|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
628249|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628250|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
628251|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628252|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
628253|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628254|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
628255|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628256|NCT00452426|E2|Reported Event|Current Standard of Care|Site's current standard used for delivery of sedation
628257|NCT00452426|E1|Reported Event|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
628258|NCT00452400|B6|Baseline|Total|Total of all reporting groups
628259|NCT00452400|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628260|NCT00452400|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628261|NCT00452400|B3|Baseline|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628262|NCT00452400|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628263|NCT00452400|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628264|NCT00452400|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628265|NCT00452400|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628266|NCT00452400|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628267|NCT00452400|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628268|NCT00452400|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628269|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628270|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628271|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628272|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628273|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628274|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628275|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628276|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628277|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628278|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628279|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628280|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628281|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628282|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628283|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628284|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628285|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628286|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628287|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628288|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628289|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628290|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628291|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628292|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628293|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628294|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628295|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628305|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628306|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628307|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628308|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628309|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628310|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628311|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628312|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628313|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628314|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628315|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628316|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628317|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628318|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628319|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628320|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628321|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628322|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628323|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628324|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628325|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628326|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628327|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628328|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628329|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628330|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628331|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628332|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628333|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628334|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628335|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628336|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628337|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628338|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628339|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628340|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628341|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628342|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628343|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628344|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628345|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628346|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628347|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628348|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628349|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628350|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628351|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628352|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628353|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628354|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628355|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628356|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628357|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628358|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628359|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628360|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628361|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628362|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628363|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628364|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628365|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628366|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628367|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628368|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628369|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628370|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628371|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628372|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628373|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628374|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628375|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628376|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628377|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628378|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628379|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628380|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628381|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628382|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628383|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628384|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628385|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628386|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628387|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628388|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628389|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628390|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628391|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628392|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628393|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628394|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628395|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628396|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628397|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628398|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628399|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628400|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628401|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628402|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628403|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628404|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628405|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628406|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628407|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628408|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628409|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628410|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628411|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628412|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628413|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628414|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628415|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628416|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628417|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628418|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628419|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628420|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628421|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628422|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628423|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628424|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628425|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628426|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628427|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628428|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628429|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628430|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628431|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628432|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628433|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628434|NCT00452400|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
628435|NCT00452400|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
628436|NCT00452400|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
628437|NCT00452400|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
628438|NCT00452400|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
628439|NCT00452387|B1|Baseline|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
628440|NCT00452387|P1|Participant Flow|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
628441|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
628442|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
628443|NCT00452387|O2|Outcome|Imaging Response (Unfavorable)|
628444|NCT00452387|O1|Outcome|Imaging Response (Favorable)|
628445|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
628446|NCT00452387|E1|Reported Event|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
628447|NCT00452374|B1|Baseline|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
628448|NCT00452374|P1|Participant Flow|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
628449|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
628450|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
628451|NCT00452374|E1|Reported Event|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
628452|NCT00452361|B3|Baseline|Total|Total of all reporting groups
628453|NCT00452361|B2|Baseline|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628454|NCT00452361|B1|Baseline|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628455|NCT00452361|P2|Participant Flow|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628534|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628535|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
629003|NCT00450450|P2|Participant Flow|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
628456|NCT00452361|P1|Participant Flow|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628457|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628458|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628459|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628460|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628461|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628462|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628463|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628464|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628465|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628536|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628537|NCT00452335|O3|Outcome|24 Mch BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628538|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628466|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628467|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628468|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628469|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628470|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628471|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628472|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628473|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628474|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628475|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628539|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628540|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628541|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628476|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628477|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628478|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628479|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628480|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628481|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628482|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628483|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628484|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628485|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628542|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628543|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628544|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628486|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628487|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628488|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628489|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628490|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628491|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628492|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628493|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628494|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628495|NCT00452361|E2|Reported Event|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
628545|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628546|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628547|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628496|NCT00452361|E1|Reported Event|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
628497|NCT00452348|B3|Baseline|Total|Total of all reporting groups
628498|NCT00452348|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628499|NCT00452348|B1|Baseline|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628500|NCT00452348|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628501|NCT00452348|P1|Participant Flow|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628502|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628503|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628504|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628505|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628506|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628507|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628508|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628509|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628510|NCT00452348|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
628511|NCT00452348|E1|Reported Event|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
628512|NCT00452335|B4|Baseline|Total|Total of all reporting groups
628513|NCT00452335|B3|Baseline|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
628514|NCT00452335|B2|Baseline|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628515|NCT00452335|B1|Baseline|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628516|NCT00452335|P3|Participant Flow|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
628517|NCT00452335|P2|Participant Flow|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628518|NCT00452335|P1|Participant Flow|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628519|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628520|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628521|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628522|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628523|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628524|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628525|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628526|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628527|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628528|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628529|NCT00452335|O2|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628530|NCT00452335|O1|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628531|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
628532|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628533|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
646275|NCT00410761|E2|Reported Event|Placebo|Placebo daily
628548|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628549|NCT00452335|E3|Reported Event|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
628550|NCT00452335|E2|Reported Event|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
628551|NCT00452335|E1|Reported Event|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
628552|NCT00452114|B3|Baseline|Total|Total of all reporting groups
628553|NCT00452114|B2|Baseline|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
628554|NCT00452114|B1|Baseline|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
628555|NCT00452114|P2|Participant Flow|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
628556|NCT00452114|P1|Participant Flow|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
628557|NCT00452114|O2|Outcome|Particpants in the Control Group (Flutter Device)|
628558|NCT00452114|O1|Outcome|Participants in the Intervention Group (Cough In-exsufflator)|
628559|NCT00452114|E2|Reported Event|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
628560|NCT00452114|E1|Reported Event|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
628561|NCT00451958|B5|Baseline|Total|Total of all reporting groups
628562|NCT00451958|B4|Baseline|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628563|NCT00451958|B3|Baseline|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628564|NCT00451958|B2|Baseline|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628565|NCT00451958|B1|Baseline|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
628566|NCT00451958|P5|Participant Flow|Leuprolide 7.5 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study."
628567|NCT00451958|P4|Participant Flow|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628568|NCT00451958|P3|Participant Flow|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628569|NCT00451958|P2|Participant Flow|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628570|NCT00451958|P1|Participant Flow|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
628571|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628572|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628573|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628574|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628575|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628576|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628577|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628578|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628579|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628622|NCT00451451|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
628580|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628581|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628582|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
628583|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628584|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628585|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628586|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
628587|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628588|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628589|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628590|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
628591|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628623|NCT00451451|P4|Participant Flow|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628592|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628593|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628594|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
628595|NCT00451958|E4|Reported Event|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628596|NCT00451958|E3|Reported Event|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628597|NCT00451958|E2|Reported Event|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
628598|NCT00451958|E1|Reported Event|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
628599|NCT00451906|B1|Baseline|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628600|NCT00451906|P1|Participant Flow|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628601|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628624|NCT00451451|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628625|NCT00451451|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628626|NCT00451451|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
628602|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628603|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628604|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628605|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628606|NCT00451906|E1|Reported Event|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
628607|NCT00451698|B3|Baseline|Total|Total of all reporting groups
628608|NCT00451698|B2|Baseline|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
628609|NCT00451698|B1|Baseline|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
628610|NCT00451698|P2|Participant Flow|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
628611|NCT00451698|P1|Participant Flow|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
628612|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
628613|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
628614|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
628615|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
628616|NCT00451698|E2|Reported Event|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
628617|NCT00451698|E1|Reported Event|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
628618|NCT00451451|B5|Baseline|Total|Total of all reporting groups
628619|NCT00451451|B4|Baseline|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628620|NCT00451451|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628621|NCT00451451|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628627|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628628|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628629|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628630|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
628631|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628632|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628633|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628634|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
628635|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628636|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628637|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628638|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
628639|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628640|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628641|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628642|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
628643|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628644|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628645|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628646|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
628647|NCT00451451|E5|Reported Event|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
628648|NCT00451451|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
628649|NCT00451451|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
628650|NCT00451451|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
628651|NCT00451451|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
628652|NCT00451321|B9|Baseline|Total|Total of all reporting groups
628653|NCT00451321|B8|Baseline|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628654|NCT00451321|B7|Baseline|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628655|NCT00451321|B6|Baseline|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628656|NCT00451321|B5|Baseline|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628657|NCT00451321|B4|Baseline|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628658|NCT00451321|B3|Baseline|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628659|NCT00451321|B2|Baseline|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628660|NCT00451321|B1|Baseline|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628661|NCT00451321|P8|Participant Flow|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628662|NCT00451321|P7|Participant Flow|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628663|NCT00451321|P6|Participant Flow|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628664|NCT00451321|P5|Participant Flow|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628665|NCT00451321|P4|Participant Flow|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628666|NCT00451321|P3|Participant Flow|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628667|NCT00451321|P2|Participant Flow|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628668|NCT00451321|P1|Participant Flow|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628669|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628670|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628671|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628672|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628673|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628674|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628675|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628676|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628677|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628678|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628679|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628680|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628681|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628682|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628683|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628684|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628685|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628686|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628687|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628688|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628689|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628690|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628691|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628692|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628939|NCT00450658|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
628940|NCT00450658|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
628693|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628694|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628695|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628696|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628697|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628698|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628699|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628700|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628701|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628702|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628703|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628704|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628705|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628706|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628707|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628708|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628709|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628710|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628711|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628712|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628713|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628714|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628715|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628716|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628717|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628718|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628719|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628720|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628941|NCT00450658|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg tablets t.i.d.
628942|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
628721|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628722|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628723|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628724|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628725|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628726|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628727|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628728|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628729|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628730|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628731|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628732|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628733|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628734|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628735|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628736|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628737|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628738|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628739|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628740|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628741|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628742|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628743|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628744|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628745|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628746|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628747|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628748|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628943|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
628944|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
628749|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628750|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628751|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628752|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628753|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628754|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628755|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628756|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628757|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628758|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628759|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628760|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628761|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628762|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628763|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628764|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628765|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628766|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628767|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628768|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628769|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628770|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628771|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628772|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628773|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628774|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628775|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628776|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628945|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
628946|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
628777|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628778|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628779|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628780|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628781|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628782|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628783|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628784|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628785|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628786|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628787|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628788|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628789|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628790|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628791|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628792|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628793|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628794|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628795|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628796|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628797|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628798|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628799|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628800|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628801|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628802|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628803|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628804|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628947|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
628948|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
628805|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628806|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628807|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628808|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628809|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628810|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628811|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628812|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628813|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628814|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628815|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628816|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628817|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628818|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628819|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628820|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628821|NCT00451321|O8|Outcome|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628822|NCT00451321|O7|Outcome|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628823|NCT00451321|O6|Outcome|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628824|NCT00451321|O5|Outcome|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628825|NCT00451321|O4|Outcome|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628826|NCT00451321|O3|Outcome|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628827|NCT00451321|O2|Outcome|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628828|NCT00451321|O1|Outcome|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628829|NCT00451321|E8|Reported Event|Otelixizumab 8.85 mg|Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628830|NCT00451321|E7|Reported Event|Otelixizumab 6.85 mg|Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
628831|NCT00451321|E6|Reported Event|Otelixizumab 4.35 mg (ITC-30)|Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
628832|NCT00451321|E5|Reported Event|Otelixizumab 4.35 mg (ITC-15)|Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
628949|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
628950|NCT00450658|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
628833|NCT00451321|E4|Reported Event|Otelixizumab 4.35 mg|Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628834|NCT00451321|E3|Reported Event|Otelixizumab 3.1 mg (5 Days)|Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
628835|NCT00451321|E2|Reported Event|Otelixizumab 3.1 mg|Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
628836|NCT00451321|E1|Reported Event|Otelixizumab <3.0 mg|Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
628837|NCT00451282|B3|Baseline|Total|Total of all reporting groups
628838|NCT00451282|B2|Baseline|Usual Care|Injured children receiving usual care
628839|NCT00451282|B1|Baseline|Intervention|Injured children receiving Stepped Preventive Care intervention
628840|NCT00451282|P2|Participant Flow|Usual Care|Injured children receiving usual care
628841|NCT00451282|P1|Participant Flow|Intervention|Injured children receiving Stepped Preventive Care intervention
628842|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
628843|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
628844|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
628845|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
628846|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
628847|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
628848|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
628849|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
628850|NCT00451282|E2|Reported Event|Usual Care|Injured children receiving usual care
628851|NCT00451282|E1|Reported Event|Intervention|Injured children receiving Stepped Preventive Care intervention
628852|NCT00451204|B3|Baseline|Total|Total of all reporting groups
628853|NCT00451204|B2|Baseline|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
628854|NCT00451204|B1|Baseline|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628855|NCT00451204|P2|Participant Flow|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
628856|NCT00451204|P1|Participant Flow|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628857|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
628858|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628859|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
628860|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628861|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
628862|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628863|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
628864|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628865|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
628866|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628867|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
628868|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628869|NCT00451204|E2|Reported Event|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
628870|NCT00451204|E1|Reported Event|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
628871|NCT00451191|B3|Baseline|Total|Total of all reporting groups
628872|NCT00451191|B2|Baseline|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628873|NCT00451191|B1|Baseline|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628874|NCT00451191|P2|Participant Flow|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628951|NCT00450658|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
628875|NCT00451191|P1|Participant Flow|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628876|NCT00451191|O2|Outcome|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628877|NCT00451191|O1|Outcome|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628878|NCT00451191|E2|Reported Event|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628879|NCT00451191|E1|Reported Event|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
628880|NCT00451048|B1|Baseline|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
628881|NCT00451048|P1|Participant Flow|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
628882|NCT00451048|O1|Outcome|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
628883|NCT00451048|E1|Reported Event|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
628884|NCT00450983|B1|Baseline|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628885|NCT00450983|P1|Participant Flow|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628886|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628887|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628888|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628889|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628890|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628891|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628892|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628893|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628894|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628895|NCT00450983|E1|Reported Event|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
628896|NCT00450866|B1|Baseline|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628897|NCT00450866|P2|Participant Flow|Epothilone B (Group B)|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628898|NCT00450866|P1|Participant Flow|Epothilone B (Group A)|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628952|NCT00450619|B3|Baseline|Total|Total of all reporting groups
629004|NCT00450450|P1|Participant Flow|Control BM Arm|Conventional bone marrow transplant (BM)
628899|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628900|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628901|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628902|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628903|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628904|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628905|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628906|NCT00450866|E1|Reported Event|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
628907|NCT00450801|B1|Baseline|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
628908|NCT00450801|P1|Participant Flow|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
628909|NCT00450801|O3|Outcome|Thalidomide Therapy|Number of patients experiencing adverse events during Thalidomide maintenance therapy.
628910|NCT00450801|O2|Outcome|R-IVAM Cycles|Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
628911|NCT00450801|O1|Outcome|R-MACLO Cycles|Number of patients experiencing adverse events during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
628912|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
628913|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
628914|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
628915|NCT00450801|E3|Reported Event|Thalidomide Therapy|Adverse Events occurring during Thalidomide maintenance therapy.
628916|NCT00450801|E2|Reported Event|R-IVAM Cycles|Adverse Events occurring during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
628917|NCT00450801|E1|Reported Event|R-MACLO Cycles|Adverse Events occurring during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
628918|NCT00450749|B4|Baseline|Total|Total of all reporting groups
628919|NCT00450749|B3|Baseline|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
628920|NCT00450749|B2|Baseline|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
628921|NCT00450749|B1|Baseline|Arm I Placebo|Placebo once daily for 4-7 weeks.
628922|NCT00450749|P3|Participant Flow|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
628923|NCT00450749|P2|Participant Flow|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
628924|NCT00450749|P1|Participant Flow|Arm I Placebo|Placebo once daily for 4-7 weeks.
628925|NCT00450749|O3|Outcome|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
628926|NCT00450749|O2|Outcome|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
628927|NCT00450749|O1|Outcome|Arm I Placebo|Placebo once daily for 4-7 weeks.
628928|NCT00450749|E3|Reported Event|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
628929|NCT00450749|E2|Reported Event|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
628930|NCT00450749|E1|Reported Event|Arm I Placebo|Placebo once daily for 4-7 weeks.
628931|NCT00450723|B1|Baseline|Single Arm|
628932|NCT00450723|P1|Participant Flow|Sentinel Lymph Node Biopsy|
628933|NCT00450723|O1|Outcome|Sentinel Lymph Node BIopsy|
628934|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
628935|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
628936|NCT00450723|E1|Reported Event|Single Arm|
628937|NCT00450658|B3|Baseline|Total|Total of all reporting groups
628938|NCT00450658|B2|Baseline|Ibuprofen|Ibuprofen 800mg
628953|NCT00450619|B2|Baseline|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628954|NCT00450619|B1|Baseline|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628955|NCT00450619|P2|Participant Flow|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628956|NCT00450619|P1|Participant Flow|Arm A- EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628957|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628958|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628959|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628960|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628961|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628962|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628963|NCT00450619|O1|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628964|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628965|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628966|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628967|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628968|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628969|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628970|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628999|NCT00450580|E1|Reported Event|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
629000|NCT00450450|B3|Baseline|Total|Total of all reporting groups
628971|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628972|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628973|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628974|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628975|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628976|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628977|NCT00450619|E2|Reported Event|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
628978|NCT00450619|E1|Reported Event|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
628979|NCT00450580|B3|Baseline|Total|Total of all reporting groups
628980|NCT00450580|B2|Baseline|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628981|NCT00450580|B1|Baseline|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628982|NCT00450580|P2|Participant Flow|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628983|NCT00450580|P1|Participant Flow|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628984|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628985|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628986|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628987|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628988|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628989|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628990|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628991|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628992|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628993|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628994|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628995|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628996|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
628997|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
628998|NCT00450580|E2|Reported Event|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
629009|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629010|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
629011|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629012|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
629013|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629014|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
629015|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629016|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
629017|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629018|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
629019|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629020|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
629021|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629022|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
629023|NCT00450450|E2|Reported Event|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
629024|NCT00450450|E1|Reported Event|Control BM Arm|Conventional bone marrow transplant (BM)
629025|NCT00450437|B3|Baseline|Total|Total of all reporting groups
629026|NCT00450437|B2|Baseline|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
629027|NCT00450437|B1|Baseline|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.
629028|NCT00450437|P4|Participant Flow|Licensed Meningococcal Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
629029|NCT00450437|P3|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
629030|NCT00450437|P2|Participant Flow|Licensed Meningococcal Vaccine (11 to 18 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
629031|NCT00450437|P1|Participant Flow|Novartis MenACWY Vaccine (11 to 18 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
629032|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
629033|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
629034|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
629035|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
629036|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
629037|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
629038|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
629039|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
629040|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the meningococcal ACWY Lot 3 conjugate vaccine was administered intramuscularly.
629041|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the meningococcal ACWY Lot 2 conjugate vaccine was administered intramuscularly.
629042|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the meningococcal ACWY Lot 1 conjugate vaccine was administered intramuscularly.
629043|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
629044|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
629045|NCT00450437|O2|Outcome|Licensed Meninogcoccal Vaccine|One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
629046|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
629047|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
629048|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
629049|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
629050|NCT00450437|E2|Reported Event|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
629051|NCT00450437|E1|Reported Event|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age.
629052|NCT00450424|B3|Baseline|Total|Total of all reporting groups
629069|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629181|NCT00450073|P3|Participant Flow|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks.
629053|NCT00450424|B2|Baseline|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
629054|NCT00450424|B1|Baseline|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
629055|NCT00450424|P2|Participant Flow|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor.
629056|NCT00450424|P1|Participant Flow|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
629057|NCT00450424|O2|Outcome|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
629058|NCT00450424|O1|Outcome|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
629059|NCT00450424|E2|Reported Event|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
629060|NCT00450424|E1|Reported Event|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
629061|NCT00450411|B1|Baseline|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
629062|NCT00450411|P1|Participant Flow|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
629063|NCT00450411|O1|Outcome|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
629064|NCT00450411|O1|Outcome|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
629065|NCT00450411|E1|Reported Event|Brachytherapy|Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
629066|NCT00450385|B1|Baseline|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629067|NCT00450385|P1|Participant Flow|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629068|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days.~Rituximab: Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles~Cyclophosphamide: Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles~Doxorubicin: Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles~Prednisone: Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.~Vincristine: Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles"
629070|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629071|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629072|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629073|NCT00450385|O1|Outcome|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629074|NCT00450385|E1|Reported Event|R-CHOP|"Patients will receive R-CHOP for 6 to 8 cycles:~Rituximab 375 mg/m2 on day 1~Cyclophosphamide 750 mg/m2 IV on day 1~Doxorubicin 50 mg/m2 on day 1~Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1~Prednisone 100 mg orally days 1-5, repeated every 21 days."
629075|NCT00450372|B1|Baseline|Single Arm|
629076|NCT00450372|P1|Participant Flow|Single Arm|
629077|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
629078|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
629079|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
629080|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
629081|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without Argininosuccinate Synthetase (ASS) expression present in tumor
629082|NCT00450372|O1|Outcome|ADI-PED 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with Argininosuccinate Synthetase (ASS) expression present in tumor
629083|NCT00450372|E1|Reported Event|Single Arm|
629084|NCT00450333|B5|Baseline|Total|Total of all reporting groups
629085|NCT00450333|B4|Baseline|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
629086|NCT00450333|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
629087|NCT00450333|B2|Baseline|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
629088|NCT00450333|B1|Baseline|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
629089|NCT00450333|P4|Participant Flow|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
629090|NCT00450333|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
629091|NCT00450333|P2|Participant Flow|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
629092|NCT00450333|P1|Participant Flow|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
629093|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
629094|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
629095|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
629096|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
629097|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
629098|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
629099|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
629100|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
629101|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
629102|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
629103|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
629104|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
629105|NCT00450333|E4|Reported Event|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
629106|NCT00450333|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
629107|NCT00450333|E2|Reported Event|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
629108|NCT00450333|E1|Reported Event|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
629109|NCT00450294|B1|Baseline|Longitudinal Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
629153|NCT00450112|B2|Baseline|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629154|NCT00450112|B1|Baseline|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629110|NCT00450294|P1|Participant Flow|Longitudinal Study Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.Measurement of Central venous pressure at event intervals during abdominal aortic aneurysm repair. Data are presented as mean +/- standard error.
629111|NCT00450294|O1|Outcome|Longitudinal Study Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair.
629112|NCT00450294|O1|Outcome|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
629113|NCT00450294|E1|Reported Event|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
629114|NCT00450255|B1|Baseline|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629115|NCT00450255|P1|Participant Flow|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629116|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629117|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629118|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629119|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629120|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629121|NCT00450255|E1|Reported Event|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
629122|NCT00450242|B3|Baseline|Total|Total of all reporting groups
629123|NCT00450242|B2|Baseline|Placebo Cream|
629124|NCT00450242|B1|Baseline|5% Lidocaine Cream|5% topical lidocaine cream.
629125|NCT00450242|P2|Participant Flow|Placebo Cream|
629126|NCT00450242|P1|Participant Flow|5% Lidocaine Cream|5% topical lidocaine cream.
629127|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
629128|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
629129|NCT00450242|O2|Outcome|Placebo Cream|topical cream vehicle.
629130|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
629131|NCT00450242|O2|Outcome|Placebo Cream|
629132|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
629133|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
629134|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
629135|NCT00450242|E2|Reported Event|Placebo Cream|
629136|NCT00450242|E1|Reported Event|5% Lidocaine Cream|5% topical lidocaine cream.
629137|NCT00450216|B3|Baseline|Total|Total of all reporting groups
629138|NCT00450216|B2|Baseline|Ibuprofen|Ibuprofen 800mg
629139|NCT00450216|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
629140|NCT00450216|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
629141|NCT00450216|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg tablets t.i.d.
629142|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
629143|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
629144|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
629145|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
629146|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
629147|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
629148|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
629149|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
629150|NCT00450216|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
629151|NCT00450216|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
629152|NCT00450112|B3|Baseline|Total|Total of all reporting groups
629178|NCT00450073|B3|Baseline|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks
629179|NCT00450073|B2|Baseline|Vitamin D2|vitamin D2 50,000 IU weekly
629155|NCT00450112|P2|Participant Flow|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629156|NCT00450112|P1|Participant Flow|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629157|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629158|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629159|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629160|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629161|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629162|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629163|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629164|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629165|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629166|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629167|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629168|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629169|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629170|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629171|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629172|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629173|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629174|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629175|NCT00450112|E2|Reported Event|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629176|NCT00450112|E1|Reported Event|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
629177|NCT00450073|B4|Baseline|Total|Total of all reporting groups
629182|NCT00450073|P2|Participant Flow|Vitamin D2|vitamin D2 50,000 IU weekly
629183|NCT00450073|P1|Participant Flow|Vitamin D3|vitamin D3 50,000 IU weekly
629184|NCT00450073|O3|Outcome|Sunlamp|Weekly use of a sunlamp
629185|NCT00450073|O2|Outcome|Vitamin D2|vitamin D2 50,000 IU weekly
629186|NCT00450073|O1|Outcome|Vitamin D3|vitamin D3 50,000 IU weekly
629187|NCT00450073|E3|Reported Event|Sunlamp|Weekly use of a sunlamp
629188|NCT00450073|E2|Reported Event|Vitamin D2|vitamin D2 50,000 IU weekly
629189|NCT00450073|E1|Reported Event|Vitamin D3|vitamin D3 50,000 IU weekly
629190|NCT00449956|B4|Baseline|Total|Total of all reporting groups
629191|NCT00449956|B3|Baseline|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
629192|NCT00449956|B2|Baseline|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
629193|NCT00449956|B1|Baseline|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
629194|NCT00449956|P3|Participant Flow|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
629195|NCT00449956|P2|Participant Flow|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
629196|NCT00449956|P1|Participant Flow|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
629197|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
629198|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
629199|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
629200|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
629201|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
629202|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
629203|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
629204|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
629205|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
629206|NCT00449956|E3|Reported Event|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
629207|NCT00449956|E2|Reported Event|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
629208|NCT00449956|E1|Reported Event|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
629209|NCT00449930|B3|Baseline|Total|Total of all reporting groups
629210|NCT00449930|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629211|NCT00449930|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629212|NCT00449930|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629213|NCT00449930|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629214|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629215|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629216|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629217|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629218|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629219|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629220|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629221|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629222|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629223|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629224|NCT00449930|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
629225|NCT00449930|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
629226|NCT00449865|B3|Baseline|Total|Total of all reporting groups
629227|NCT00449865|B2|Baseline|Creatine|creatine 5 grams twice daily
629228|NCT00449865|B1|Baseline|Placebo|placebo: an inactive substance
629229|NCT00449865|P2|Participant Flow|Creatine|creatine monohydrate (10 gram /day)
629230|NCT00449865|P1|Participant Flow|Placebo|placebo: an inactive substance
629231|NCT00449865|O2|Outcome|Creatine|creatine monohydrate (10 grams/day)
629232|NCT00449865|O1|Outcome|Placebo|placebo: an inactive substance
629233|NCT00449865|E2|Reported Event|Creatine|creatine 5 grams twice daily
629234|NCT00449865|E1|Reported Event|Placebo|placebo: an inactive substance
629235|NCT00449787|B3|Baseline|Total|Total of all reporting groups
629236|NCT00449787|B2|Baseline|Naproxen|Naproxen 500 mg tablet
629237|NCT00449787|B1|Baseline|Sumatriptan|Sumatriptan 100 mg tablet
629238|NCT00449787|P2|Participant Flow|Naproxen|Naproxen 500 mg tablet
629239|NCT00449787|P1|Participant Flow|Sumatriptan|Sumatriptan 100 mg tablet
629240|NCT00449787|O2|Outcome|Naproxen|Naproxen 500 mg tablet
629241|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100 mg tablet
629242|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
629243|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
629244|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
629245|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
629246|NCT00449787|E2|Reported Event|Naproxen|Naproxen 500 mg tablet
629247|NCT00449787|E1|Reported Event|Sumatriptan|Sumatriptan 100 mg tablet
629248|NCT00449748|B1|Baseline|RAD001|Oral RAD001 10 mg daily for 30 days
629249|NCT00449748|P1|Participant Flow|RAD001|Oral RAD001 10 mg daily for 30 days
629250|NCT00449748|O1|Outcome|RAD001|Oral RAD001 10 mg daily for 30 days
629251|NCT00449748|E1|Reported Event|RAD001|Oral RAD001 10 mg daily for 30 days
629252|NCT00449696|B3|Baseline|Total|Total of all reporting groups
629253|NCT00449696|B2|Baseline|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629254|NCT00449696|B1|Baseline|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629255|NCT00449696|P2|Participant Flow|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629256|NCT00449696|P1|Participant Flow|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629257|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629258|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629259|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629260|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629261|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629262|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629263|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629264|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629265|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629266|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629267|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629268|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629269|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629270|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629271|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629272|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629273|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629274|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629275|NCT00449696|E2|Reported Event|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
629276|NCT00449696|E1|Reported Event|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
629278|NCT00449644|B4|Baseline|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629279|NCT00449644|B3|Baseline|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629280|NCT00449644|B2|Baseline|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629281|NCT00449644|B1|Baseline|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629282|NCT00449644|P4|Participant Flow|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629283|NCT00449644|P3|Participant Flow|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629284|NCT00449644|P2|Participant Flow|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629285|NCT00449644|P1|Participant Flow|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629286|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629287|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
629288|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week.
629289|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
629290|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629291|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629292|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629293|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
629294|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629295|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629296|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629297|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
629298|NCT00449644|E4|Reported Event|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629299|NCT00449644|E3|Reported Event|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
629300|NCT00449644|E2|Reported Event|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629301|NCT00449644|E1|Reported Event|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
629302|NCT00449540|B3|Baseline|Total|Total of all reporting groups
629303|NCT00449540|B2|Baseline|Sham TMS Device|Simulated Sham treatment without TMS
629304|NCT00449540|B1|Baseline|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
629305|NCT00449540|P3|Participant Flow|Sham TMS Device|Device which does not deliver TMS pulse
629306|NCT00449540|P2|Participant Flow|Active TMS|Active Transcranial Magnetic Stimulation Device
629307|NCT00449540|P1|Participant Flow|30 Day Lead in Phase|some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
629308|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
629309|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
629310|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
629311|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
629312|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
629313|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
629314|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
629315|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
629316|NCT00449540|E4|Reported Event|Sham TMS Device - Not Treatment Related|Sham TMS Device - events that are not treatment related
629317|NCT00449540|E3|Reported Event|Active TMS - Not Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related
629318|NCT00449540|E2|Reported Event|Sham TMS Device - Treatment Related|Simulated Sham treatment without TMS
629319|NCT00449540|E1|Reported Event|Active TMS Device - Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Treatment related
629320|NCT00449176|B4|Baseline|Total|Total of all reporting groups
629321|NCT00449176|B3|Baseline|Placebo|Matching Placebo twice daily(BID)
629322|NCT00449176|B2|Baseline|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629323|NCT00449176|B1|Baseline|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629324|NCT00449176|P3|Participant Flow|Placebo|Matching Placebo twice daily(BID)
629325|NCT00449176|P2|Participant Flow|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629326|NCT00449176|P1|Participant Flow|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629327|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
629328|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629329|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629330|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
629331|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629332|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629333|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
629334|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629335|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629336|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
629337|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629338|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629339|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
629340|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629341|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629342|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
629343|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629344|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629345|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
629346|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629347|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629348|NCT00449176|E3|Reported Event|Placebo|Matching Placebo twice daily(BID)
629349|NCT00449176|E2|Reported Event|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
629350|NCT00449176|E1|Reported Event|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
629351|NCT00449163|B1|Baseline|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
629352|NCT00449163|P1|Participant Flow|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
629381|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629574|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
629575|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
629353|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
629354|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
629355|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
629356|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
629357|NCT00449163|E1|Reported Event|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
629358|NCT00449150|B4|Baseline|Total|Total of all reporting groups
629359|NCT00449150|B3|Baseline|Placebo|Placebo on Week 0, 2 26 and 28
629360|NCT00449150|B2|Baseline|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
629361|NCT00449150|B1|Baseline|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
629362|NCT00449150|P3|Participant Flow|Placebo|Placebo on Week 0, 2 26 and 28
629363|NCT00449150|P2|Participant Flow|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
629364|NCT00449150|P1|Participant Flow|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
629365|NCT00449150|O3|Outcome|Placebo|Placebo on Week 0, 2 26 and 28
629366|NCT00449150|O2|Outcome|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
629367|NCT00449150|O1|Outcome|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
629368|NCT00449150|E3|Reported Event|Placebo|Placebo on Week 0, 2 26 and 28
629369|NCT00449150|E2|Reported Event|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
629370|NCT00449150|E1|Reported Event|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
629371|NCT00449072|B3|Baseline|Total|Total of all reporting groups
629372|NCT00449072|B2|Baseline|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
629373|NCT00449072|B1|Baseline|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
629374|NCT00449072|P2|Participant Flow|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
629375|NCT00449072|P1|Participant Flow|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
629376|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629377|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629378|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629379|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629380|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629382|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629383|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629384|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629385|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629386|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629387|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629388|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629389|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629390|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629391|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629392|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629393|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629394|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629395|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
629396|NCT00449072|E2|Reported Event|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
629397|NCT00449072|E1|Reported Event|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
629398|NCT00449046|B1|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629399|NCT00449046|P1|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629400|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629401|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629402|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629403|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629404|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629405|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629406|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629407|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629408|NCT00449046|E1|Reported Event|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
629410|NCT00449033|B2|Baseline|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629411|NCT00449033|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629412|NCT00449033|P2|Participant Flow|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629413|NCT00449033|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629414|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629415|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629416|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629417|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629418|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629419|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629420|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629421|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629422|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629576|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
629423|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629424|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629425|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629426|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629427|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629428|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629429|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629430|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629431|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629432|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629433|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629434|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629435|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
649745|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
629436|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629437|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629438|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629439|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629440|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629441|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629442|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629443|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629444|NCT00449033|E2|Reported Event|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
629445|NCT00449033|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
629446|NCT00448916|B5|Baseline|Total|Total of all reporting groups
629447|NCT00448916|B4|Baseline|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629448|NCT00448916|B3|Baseline|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629449|NCT00448916|B2|Baseline|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629450|NCT00448916|B1|Baseline|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629451|NCT00448916|P4|Participant Flow|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629452|NCT00448916|P3|Participant Flow|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
649746|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
629453|NCT00448916|P2|Participant Flow|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629454|NCT00448916|P1|Participant Flow|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629455|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629456|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629457|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629458|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629459|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629460|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629461|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629462|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629463|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629464|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629465|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629466|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629467|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629468|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629469|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629470|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629471|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629472|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629473|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629474|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629475|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629476|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629477|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629478|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629479|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629480|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629481|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629482|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629483|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629577|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
629484|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629485|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629486|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629487|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629488|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629489|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629490|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629491|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629492|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629493|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629494|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629495|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629496|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629497|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629498|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629499|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629500|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629501|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629502|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629503|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629504|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629505|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629506|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629507|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
629508|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629509|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629510|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629511|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629512|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629513|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629514|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
649747|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
629515|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629516|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629517|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629518|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629519|NCT00448916|E5|Reported Event|Overall|This arm summarizes the AE data from all the treatment groups.
629520|NCT00448916|E4|Reported Event|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629521|NCT00448916|E3|Reported Event|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
629522|NCT00448916|E2|Reported Event|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
629523|NCT00448916|E1|Reported Event|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
629524|NCT00448864|B4|Baseline|Total|Total of all reporting groups
629525|NCT00448864|B3|Baseline|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
629526|NCT00448864|B2|Baseline|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
629527|NCT00448864|B1|Baseline|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
629528|NCT00448864|P3|Participant Flow|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
629529|NCT00448864|P2|Participant Flow|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
629530|NCT00448864|P1|Participant Flow|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
629531|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
629532|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
629533|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
629534|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
629535|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
629578|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
629579|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
629536|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
629537|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
629538|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
629539|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
629540|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
629541|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
629542|NCT00448864|E3|Reported Event|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
629543|NCT00448864|E2|Reported Event|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
629544|NCT00448864|E1|Reported Event|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
629545|NCT00448760|B1|Baseline|Single Arm|5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel
629546|NCT00448760|P1|Participant Flow|Neoadjuvant + Adjuvant Chemotherapy|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
629547|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
629548|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
629549|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
629550|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
629580|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
629581|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
629582|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
629583|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
629584|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
629551|NCT00448760|E1|Reported Event|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
629552|NCT00448708|B3|Baseline|Total|Total of all reporting groups
629553|NCT00448708|B2|Baseline|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
629554|NCT00448708|B1|Baseline|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
629555|NCT00448708|P2|Participant Flow|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
629556|NCT00448708|P1|Participant Flow|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
629557|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
629558|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
629559|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
629560|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
629561|NCT00448708|E2|Reported Event|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
629562|NCT00448708|E1|Reported Event|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
629563|NCT00448682|B1|Baseline|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
629564|NCT00448682|P1|Participant Flow|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
629565|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
629566|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
629567|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
629568|NCT00448682|E1|Reported Event|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
629569|NCT00448630|B1|Baseline|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629570|NCT00448630|P1|Participant Flow|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629571|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
629572|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
629573|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
649748|NCT00402987|O4|Outcome|Placebo|
629585|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
629586|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
629587|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
629588|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
629589|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
629590|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
629591|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
629592|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629593|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629594|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629595|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629596|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629597|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629598|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629599|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
629600|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
629601|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
629602|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
629603|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
629604|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
629605|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
629606|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
629607|NCT00448630|E7|Reported Event|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
629608|NCT00448630|E6|Reported Event|Amisulpride|amisulpride as prescribed by subject's physician
629609|NCT00448630|E5|Reported Event|Aripiprazole|aripiprazole as prescribed by subject's physician
629610|NCT00448630|E4|Reported Event|Olanzipine|olanzipine as prescribed by subject's physician
629611|NCT00448630|E3|Reported Event|Quetiapine|quetiapine as prescribed by subject's physician
629612|NCT00448630|E2|Reported Event|Risperidone|risperidone as prescribed by subject's physician
629613|NCT00448630|E1|Reported Event|Ziprasidone|ziprasidone as prescribed by subject's physician
629614|NCT00448591|B1|Baseline|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
629615|NCT00448591|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
629616|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
629617|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
629651|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
649749|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
629618|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
629619|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
629620|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
629621|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
629622|NCT00448591|E1|Reported Event|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
629623|NCT00448539|B3|Baseline|Total|Total of all reporting groups
629624|NCT00448539|B2|Baseline|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629625|NCT00448539|B1|Baseline|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629626|NCT00448539|P2|Participant Flow|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629627|NCT00448539|P1|Participant Flow|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629628|NCT00448539|O2|Outcome|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629629|NCT00448539|O1|Outcome|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629652|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629653|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
629809|NCT00448123|P1|Participant Flow|Placebo|None active placebo orally per day for up to 10 days.
629630|NCT00448539|E2|Reported Event|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629631|NCT00448539|E1|Reported Event|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
629632|NCT00448448|B3|Baseline|Total|Total of all reporting groups
629633|NCT00448448|B2|Baseline|Observation|Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
629634|NCT00448448|B1|Baseline|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function."
629635|NCT00448448|P2|Participant Flow|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
629636|NCT00448448|P1|Participant Flow|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
629637|NCT00448448|O2|Outcome|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
629638|NCT00448448|O1|Outcome|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
629639|NCT00448448|E2|Reported Event|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
629640|NCT00448448|E1|Reported Event|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
629641|NCT00448435|B1|Baseline|Overall Study Population|Randomized Population
629642|NCT00448435|P2|Participant Flow|SLM 50 Mcg + FP 100 Mcg/Day First|SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).
629643|NCT00448435|P1|Participant Flow|SFC 50/100 Mcg/Day First|GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).
629644|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629645|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629646|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629647|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629648|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629649|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629650|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629757|NCT00448175|B3|Baseline|Total|Total of all reporting groups
649750|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
629654|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629655|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
629656|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629657|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
629658|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629659|NCT00448435|O2|Outcome|SLM 50mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily
629660|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629661|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
629662|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629663|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
629664|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
629665|NCT00448435|E3|Reported Event|SFC 50/100mcg/Day (Extension Period)|Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
629666|NCT00448435|E2|Reported Event|SLM 50 + FP 100 Mcg/Day|Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
629667|NCT00448435|E1|Reported Event|SFC 50/100 Mcg/Day|Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
629668|NCT00448357|B1|Baseline|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis~Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
629669|NCT00448357|P1|Participant Flow|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis~Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
629670|NCT00448357|O3|Outcome|High Busulfan AUC Tertile (7605)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
629671|NCT00448357|O2|Outcome|Intermediate Busulfan AUC Tertile (6372)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
629672|NCT00448357|O1|Outcome|Low Busulfan AUC Tertile (5078)|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
629673|NCT00448357|O1|Outcome|Experimental: GVHD Prophylaxis|"Matched related donor (MRD) subjects receive Graft Vs Host Disease (GVHD )prophylaxis with Methotrexate alone Subjects also receive busulfan, fludarabine, and tacrolimus and may receive Alemtuzumab.~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
629674|NCT00448357|O3|Outcome|High Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
629675|NCT00448357|O2|Outcome|Intermediate Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
629676|NCT00448357|O1|Outcome|Low Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
629677|NCT00448357|O5|Outcome|Dose Level 5|Target AUC/24 hrs of 8363 uM-min+/- 15%
629678|NCT00448357|O4|Outcome|Dose Level 4|Target AUC/24 hrs of 7603 uM-min+/- 15%
629679|NCT00448357|O3|Outcome|Dose Level 3|Target AUC/24 hrs of 6912 uM-min +/- 15%
629680|NCT00448357|O2|Outcome|Dose Level 2|Target AUC/24 hrs of 5760 uM-min +/- 15%
629681|NCT00448357|O1|Outcome|Dose Level 1|Target AUC/24 hrs of 4800 uM-min +/-15%
629682|NCT00448357|O5|Outcome|Dose Level 5|Target AUC/24 hrs of 8363 uM-min+/- 15%
629683|NCT00448357|O4|Outcome|Dose Level 4|Target AUC/24 hrs of 7603 uM-min+/- 15%
629684|NCT00448357|O3|Outcome|Dose Level 3|Target AUC/24 hrs of 6912 uM-min +/- 15%
629685|NCT00448357|O2|Outcome|Dose Level 2|Target AUC/24 hrs of 5760 uM-min +/- 15%
629686|NCT00448357|O1|Outcome|Dose Level 1|Target AUC/24 hrs of 4800 micrometer (uM)-min +/-15%
629687|NCT00448357|O3|Outcome|High Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
629688|NCT00448357|O2|Outcome|Intermediate Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
629689|NCT00448357|O1|Outcome|Low Busulfan AUC Tertile|Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
629690|NCT00448357|E1|Reported Event|Experimental: GVHD Prophylaxis|"Experimental: GVHD prophylaxis~Subjects with matched-related donors (MRDs) were treated with tacrolimus and methotrexate with or without alemtuzumab for graft vs host disease prophylaxis Subjects also receive busulfan and fludarabine .~Matched unrelated donor (MUD) or mismatched related donor (MMRD) subjects receive GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) + Methotrexate Subjects also receive busulfan, fludarabine, and tacrolimus."
629691|NCT00448344|B3|Baseline|Total|Total of all reporting groups
629692|NCT00448344|B2|Baseline|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
629693|NCT00448344|B1|Baseline|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
629694|NCT00448344|P2|Participant Flow|Standard Smoking Cessation|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
629695|NCT00448344|P1|Participant Flow|Family-supported Smoking Cessation|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
629696|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
629697|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
629698|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
629699|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
629700|NCT00448344|E2|Reported Event|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
629701|NCT00448344|E1|Reported Event|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
629702|NCT00448279|B3|Baseline|Total|Total of all reporting groups
629703|NCT00448279|B2|Baseline|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629704|NCT00448279|B1|Baseline|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629705|NCT00448279|P2|Participant Flow|Chemotherapy Plus (+) Trastuzumab|Participants received trastuzumab at either 2 milligrams per kilogram (mg/kg), intravenously (IV), every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629706|NCT00448279|P1|Participant Flow|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629707|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629708|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629709|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629710|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629711|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629712|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629713|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629714|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629715|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629716|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629717|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629718|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629719|NCT00448279|E2|Reported Event|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
629720|NCT00448279|E1|Reported Event|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
629721|NCT00448227|B1|Baseline|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629722|NCT00448227|P1|Participant Flow|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629723|NCT00448227|O4|Outcome|Total|
629724|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629725|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629726|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629727|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629728|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629729|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629730|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629731|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629808|NCT00448123|P2|Participant Flow|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
629732|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629733|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629734|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629735|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629736|NCT00448227|O4|Outcome|Total|
629737|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629738|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629739|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629740|NCT00448227|O4|Outcome|Total|
629741|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629742|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629743|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629744|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629745|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629746|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629747|NCT00448227|E1|Reported Event|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
629748|NCT00448201|B1|Baseline|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
629749|NCT00448201|P1|Participant Flow|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
629750|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
629751|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
629752|NCT00448201|O2|Outcome|Day 90|90 days post-transplant
629753|NCT00448201|O1|Outcome|Day 60|60 days post-transplant
629754|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
629755|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
629756|NCT00448201|E1|Reported Event|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
629758|NCT00448175|B2|Baseline|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
629759|NCT00448175|B1|Baseline|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
629760|NCT00448175|P2|Participant Flow|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
629761|NCT00448175|P1|Participant Flow|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
629762|NCT00448175|O2|Outcome|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
629763|NCT00448175|O1|Outcome|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
629764|NCT00448175|E2|Reported Event|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
629765|NCT00448175|E1|Reported Event|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
629766|NCT00448136|B3|Baseline|Total|Total of all reporting groups
629767|NCT00448136|B2|Baseline|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629768|NCT00448136|B1|Baseline|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629769|NCT00448136|P2|Participant Flow|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629770|NCT00448136|P1|Participant Flow|Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629771|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629772|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629773|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629774|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629775|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629776|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629777|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629778|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629779|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629780|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629781|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629782|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
649751|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
629783|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629784|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629785|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629786|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629787|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629788|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629789|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629790|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629791|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629792|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629793|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629794|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629795|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629796|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629797|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629798|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629799|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629800|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629801|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629802|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629803|NCT00448136|E2|Reported Event|Bevacizumab + Capecitabine|Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
629804|NCT00448136|E1|Reported Event|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
629805|NCT00448123|B3|Baseline|Total|Total of all reporting groups
629806|NCT00448123|B2|Baseline|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
629807|NCT00448123|B1|Baseline|Placebo|Placebo Group
649752|NCT00402987|O4|Outcome|Placebo|
629810|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
629811|NCT00448123|O1|Outcome|Placebo|"Placebo~Placebo: Placebo"
629812|NCT00448123|O2|Outcome|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
629813|NCT00448123|O1|Outcome|Placebo|Active placebo orally per day for up to 10 days.
629814|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
629815|NCT00448123|O1|Outcome|Placebo|Placebo Group
629816|NCT00448123|E2|Reported Event|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
629817|NCT00448123|E1|Reported Event|Placebo|Placebo Group
629818|NCT00448019|B1|Baseline|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
629819|NCT00448019|P1|Participant Flow|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
629820|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
629821|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
629822|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
629823|NCT00448019|E1|Reported Event|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
629824|NCT00447902|B3|Baseline|Total|Total of all reporting groups
629825|NCT00447902|B2|Baseline|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629826|NCT00447902|B1|Baseline|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629827|NCT00447902|P2|Participant Flow|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629828|NCT00447902|P1|Participant Flow|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629829|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629830|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629831|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629832|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629833|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629834|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629835|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629836|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629837|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629838|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629839|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629840|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629841|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629842|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629843|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629844|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629845|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629846|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629847|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629848|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
630068|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 Milligrams (mg)|Open-label lapatinib 1500 mg orally, once a day
629849|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629850|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629851|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629852|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629853|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629854|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629855|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629856|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629857|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629858|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629859|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629860|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629861|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629862|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629863|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629864|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629865|NCT00447902|E2|Reported Event|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
629866|NCT00447902|E1|Reported Event|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
629867|NCT00447876|B3|Baseline|Total Title|
629868|NCT00447876|B2|Baseline|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629869|NCT00447876|B1|Baseline|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629870|NCT00447876|P2|Participant Flow|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629871|NCT00447876|P1|Participant Flow|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629872|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629873|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629874|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629912|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
630020|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
629875|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629876|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629877|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629878|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629879|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629880|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629881|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629882|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629883|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629884|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629885|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629886|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629887|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629888|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629889|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629913|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
649753|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
629890|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629891|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629892|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629893|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629894|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629895|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629896|NCT00447876|O2|Outcome|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629897|NCT00447876|O1|Outcome|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629898|NCT00447876|E2|Reported Event|Placebo|Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629899|NCT00447876|E1|Reported Event|Dysport ® 200 U|Patients received one injection of 200 units (U) Dysport® at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.
629900|NCT00447603|B1|Baseline|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
629901|NCT00447603|P3|Participant Flow|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
629902|NCT00447603|P2|Participant Flow|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
629903|NCT00447603|P1|Participant Flow|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
629904|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
629905|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
629906|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629907|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629908|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
629909|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
629910|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629911|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629914|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629915|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629916|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
629917|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
629918|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629919|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
629920|NCT00447603|E2|Reported Event|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
629921|NCT00447603|E1|Reported Event|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
629922|NCT00447590|B1|Baseline|LAP-BAND|All subjects who received the LAP-BAND System.
629923|NCT00447590|P1|Participant Flow|LAP-BAND|All subjects who received the LAP-BAND System.
629924|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
629925|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
629926|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
629927|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
629928|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
629929|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
629930|NCT00447590|E1|Reported Event|LAP-BAND|All subjects who received the LAP-BAND System.
629931|NCT00447499|B1|Baseline|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
629932|NCT00447499|P1|Participant Flow|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
629933|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
629934|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
629935|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
629936|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)|Somatuline Autogel (lanreotide acetate) Injection/Switch Patient
629937|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
629938|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
629939|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
629940|NCT00447499|E1|Reported Event|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
629941|NCT00447421|B1|Baseline|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629942|NCT00447421|P1|Participant Flow|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629943|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629944|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629945|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629946|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629947|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
630689|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
629948|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629949|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629950|NCT00447421|E1|Reported Event|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
629951|NCT00447382|B3|Baseline|Total|Total of all reporting groups
629952|NCT00447382|B2|Baseline|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629953|NCT00447382|B1|Baseline|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629954|NCT00447382|P2|Participant Flow|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629955|NCT00447382|P1|Participant Flow|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629956|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629957|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629958|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629959|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629960|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629961|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629962|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629963|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629964|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629965|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629966|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629967|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629968|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629969|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629970|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629971|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629972|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630019|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
629973|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629974|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629975|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629976|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629977|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629978|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629979|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629980|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629981|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629982|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629983|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629984|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629985|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629986|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629987|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629988|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629989|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629990|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629991|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629992|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629993|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629994|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629995|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629996|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629997|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
629998|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630690|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
629999|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630000|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630001|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630002|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630003|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630004|NCT00447382|E2|Reported Event|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630005|NCT00447382|E1|Reported Event|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
630006|NCT00447330|B1|Baseline|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
630007|NCT00447330|P1|Participant Flow|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
630008|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
630009|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
630010|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
630011|NCT00447330|O1|Outcome|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
630012|NCT00447330|E1|Reported Event|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
630013|NCT00447278|B3|Baseline|Total|Total of all reporting groups
630014|NCT00447278|B2|Baseline|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630015|NCT00447278|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630016|NCT00447278|P2|Participant Flow|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630017|NCT00447278|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630018|NCT00447278|O1|Outcome|Pearson Correlation Coefficient|Correlation Coefficient between parent-rated and patient-rated CHIP T-score domains.
630067|NCT00447226|O1|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
630021|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630022|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630023|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630024|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630025|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630026|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630027|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630028|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630029|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630030|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630031|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630032|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630033|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630034|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630035|NCT00447278|E2|Reported Event|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
630036|NCT00447278|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
630037|NCT00447265|B1|Baseline|Etanercept|Participant self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks. She continued receiving her usual treatment with corticosteroids and mycophenolate mofetil.
630038|NCT00447265|P2|Participant Flow|Placebo|Participants (or their caretaker) would administer 50 mg placebo subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
630039|NCT00447265|P1|Participant Flow|Etanercept|Participants (or their caretaker) would administer 50 mg etanercept subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
630040|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630041|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630042|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630043|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630044|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630045|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630046|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630047|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630048|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630049|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
630050|NCT00447265|E1|Reported Event|Etanercept|Participant received self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks while continuing to receive her usual lupus treatment of corticosteroids and mycophenolate mofetil.
630051|NCT00447226|B1|Baseline|All Participants|All participants treated in the open-label phase (1500 milligrams [mg] lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
630052|NCT00447226|P2|Participant Flow|Lapatinib 1500 Milligrams (mg)|Lapatinib 1500 mg orally, once a day
630053|NCT00447226|P1|Participant Flow|Placebo|Identical matching placebo orally, once a day
630054|NCT00447226|O1|Outcome|All Screened Participants|All screened participants
630055|NCT00447226|O1|Outcome|Screened Participants With Gastric Cancer|Screened participants with gastric cancer
630056|NCT00447226|O1|Outcome|All Participants With Ovarian Cancer|All participants with ovarian cancer treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
630057|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day: up to end of Stage 2
630058|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day: up to end of Stage 2
630059|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day: up to end of Stage 1
630060|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
630061|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
630062|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
630063|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
630064|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
630065|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
630066|NCT00447226|O2|Outcome|Placebo|Identical matching placebo orally, once a day
630069|NCT00447226|E1|Reported Event|All Participants|All participants treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
630070|NCT00447122|B1|Baseline|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
630071|NCT00447122|P1|Participant Flow|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
630072|NCT00447122|O1|Outcome|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
630073|NCT00447122|E1|Reported Event|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
630074|NCT00447057|B5|Baseline|Total|Total of all reporting groups
630075|NCT00447057|B4|Baseline|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
630076|NCT00447057|B3|Baseline|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630077|NCT00447057|B2|Baseline|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630078|NCT00447057|B1|Baseline|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
630079|NCT00447057|P4|Participant Flow|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
630080|NCT00447057|P3|Participant Flow|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630081|NCT00447057|P2|Participant Flow|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle"
630082|NCT00447057|P1|Participant Flow|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
630083|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630084|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630085|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630086|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630087|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630088|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630089|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630090|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630091|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630092|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630093|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630094|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630095|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630096|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630097|NCT00447057|E2|Reported Event|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
630098|NCT00447057|E1|Reported Event|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
630150|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630099|NCT00447005|B1|Baseline|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630100|NCT00447005|P1|Participant Flow|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630101|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630102|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630103|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630104|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630105|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630106|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630107|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630108|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630109|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630110|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630111|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630151|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630112|NCT00447005|E1|Reported Event|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
630113|NCT00446992|B1|Baseline|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630114|NCT00446992|P1|Participant Flow|Antipsychotic-Naive Patients|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630115|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630116|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630117|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630118|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630119|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630120|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630121|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630122|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630123|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630124|NCT00446992|E1|Reported Event|Open Follow Up Group|"The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
630125|NCT00446849|B1|Baseline|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. A total of 208 subjects entered the maintenance phase (152 whose UC was quiescent at screening + 56 whose UC was quiescent after the acute phase).
630126|NCT00446849|P1|Participant Flow|Multi-Matrix System (MMX) Mesalamine|Subjects whose ulcerative colitis (UC) was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed orally once-daily [QD] at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630127|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630360|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630691|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630128|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630129|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630130|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630131|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630132|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630133|NCT00446849|E2|Reported Event|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
630134|NCT00446849|E1|Reported Event|MMX Mesalamine (Acute Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day).
630135|NCT00446797|B3|Baseline|Total|Total of all reporting groups
630136|NCT00446797|B2|Baseline|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630137|NCT00446797|B1|Baseline|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630138|NCT00446797|P2|Participant Flow|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630139|NCT00446797|P1|Participant Flow|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630140|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630141|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630142|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630143|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630144|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630145|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630146|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630147|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630148|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630149|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630647|NCT00445705|E4|Reported Event|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
630152|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630153|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630154|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630155|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630156|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630157|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630158|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630159|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630160|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630161|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630162|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630163|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630164|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630165|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630166|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630167|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630168|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630169|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630170|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630171|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630172|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630173|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630174|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630175|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
649754|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
630176|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630177|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630178|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630179|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630180|NCT00446797|E2|Reported Event|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
630181|NCT00446797|E1|Reported Event|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
630182|NCT00446654|B3|Baseline|Total|Total of all reporting groups
630183|NCT00446654|B2|Baseline|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
630184|NCT00446654|B1|Baseline|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
630185|NCT00446654|P2|Participant Flow|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
630186|NCT00446654|P1|Participant Flow|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
630187|NCT00446654|O2|Outcome|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
630188|NCT00446654|O1|Outcome|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
630189|NCT00446654|E2|Reported Event|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
630190|NCT00446654|E1|Reported Event|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
630191|NCT00446641|B3|Baseline|Total|Total of all reporting groups
630192|NCT00446641|B2|Baseline|Placebo|matching placebo to cilostazol
630193|NCT00446641|B1|Baseline|Cilostazol|Cilostazol 100mg twice per day
630194|NCT00446641|P2|Participant Flow|Placebo|matching placebo to cilostazol
630195|NCT00446641|P1|Participant Flow|Cilostazol|Cilostazol 100mg twice per day
630196|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
630197|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
630198|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
630199|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
630200|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
630201|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
630202|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
630203|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
630204|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
630205|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
630206|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
630207|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
630208|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
630209|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
630210|NCT00446641|E2|Reported Event|Placebo|matching placebo to cilostazol
630211|NCT00446641|E1|Reported Event|Cilostazol|Cilostazol 100mg twice per day
630212|NCT00446563|B3|Baseline|Total|Total of all reporting groups
630213|NCT00446563|B2|Baseline|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630214|NCT00446563|B1|Baseline|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630215|NCT00446563|P2|Participant Flow|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630216|NCT00446563|P1|Participant Flow|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630217|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630218|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630219|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630220|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630221|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630222|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630223|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630224|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630225|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630226|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630227|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630228|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630229|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630230|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630231|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630232|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630233|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630234|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630235|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630236|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630237|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630238|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630239|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630240|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630241|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630242|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630243|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630244|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630245|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630246|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630247|NCT00446563|E2|Reported Event|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630248|NCT00446563|E1|Reported Event|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
630249|NCT00446511|B5|Baseline|Total|Total of all reporting groups
630250|NCT00446511|B4|Baseline|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630251|NCT00446511|B3|Baseline|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630252|NCT00446511|B2|Baseline|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630253|NCT00446511|B1|Baseline|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630254|NCT00446511|P4|Participant Flow|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630255|NCT00446511|P3|Participant Flow|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630256|NCT00446511|P2|Participant Flow|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630257|NCT00446511|P1|Participant Flow|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630258|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630648|NCT00445705|E3|Reported Event|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
630259|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630260|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630261|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630262|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630263|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630264|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630265|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630266|NCT00446511|O2|Outcome|Non-CKD Patients: Enalapril|All non-CKD patients assigned to enalapril in the core study (CVAL489K2302) continued their monotherapy treatment of enalapril 10/20/40 mg stratified by weight.
630267|NCT00446511|O1|Outcome|Non-CKD Patients: Valsartan|All non-CKD patients assigned to valsartan in the core study (CVAL489K2302) continued their monotherapy treatment of valsartan 80/160/320 mg stratified by weight.
630268|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630269|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630270|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630271|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630272|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630273|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630274|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630275|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630276|NCT00446511|E4|Reported Event|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630277|NCT00446511|E3|Reported Event|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630316|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
630278|NCT00446511|E2|Reported Event|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630279|NCT00446511|E1|Reported Event|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
630280|NCT00446459|B1|Baseline|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630281|NCT00446459|P1|Participant Flow|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630282|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630283|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630284|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630285|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630286|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630287|NCT00446459|E1|Reported Event|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
630288|NCT00446446|B1|Baseline|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630289|NCT00446446|P1|Participant Flow|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630290|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630291|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630292|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630293|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630294|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630295|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630296|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630297|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630298|NCT00446446|E1|Reported Event|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
630299|NCT00446290|B1|Baseline|DXP Arm|Docetaxel, capecitabine and oxaliplatin
630300|NCT00446290|P1|Participant Flow|DXO Arm|"Docetaxel, capecitabine and oxaliplatin~Dose level Docetaxel(mg/m2) Capecitabine(mg/m2, twice daily) Oxaliplatin(mg/m2)~45 800 100~60 800 100~60 1,000 100~60 800 130~60 1,000 130"
630301|NCT00446290|O1|Outcome|DXO Arm|Docetaxel, capecitabine and oxaliplatin
630302|NCT00446290|E1|Reported Event|DXO Arm|Docetaxel, capecitabine and oxaliplatin
630303|NCT00446264|B1|Baseline|Single Arm Group|Islet Allotransplantation Group
630304|NCT00446264|P1|Participant Flow|Single Arm Group|Islet Allotransplantation Group
630305|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
630306|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
630307|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
630308|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
630309|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
630310|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
630311|NCT00446264|E1|Reported Event|Single Arm Group|Islet Allotransplantation Group
630312|NCT00446251|B1|Baseline|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
630313|NCT00446251|P1|Participant Flow|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
630314|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
630315|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
630317|NCT00446251|E1|Reported Event|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
630318|NCT00446199|B5|Baseline|Total|Total of all reporting groups
630319|NCT00446199|B4|Baseline|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630320|NCT00446199|B3|Baseline|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630321|NCT00446199|B2|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630322|NCT00446199|B1|Baseline|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630323|NCT00446199|P4|Participant Flow|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630324|NCT00446199|P3|Participant Flow|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630325|NCT00446199|P2|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630326|NCT00446199|P1|Participant Flow|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630327|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630328|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630329|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630330|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630331|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630332|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630333|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630334|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630335|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630336|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630337|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630338|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630339|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630340|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630341|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630342|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630343|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630344|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630345|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630346|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630347|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630348|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630349|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630350|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630351|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630352|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630353|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630354|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630355|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630356|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630357|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630358|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630359|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
649755|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
630361|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630362|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630363|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630364|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630365|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630366|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630367|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630368|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630369|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630370|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630371|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630372|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630373|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630374|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630375|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630376|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630377|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630378|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630379|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630380|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630381|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630382|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630383|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630384|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630385|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630386|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630387|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630388|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630389|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630390|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630391|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630392|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630393|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630394|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630395|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630396|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
630397|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630398|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630399|NCT00446199|E4|Reported Event|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
630400|NCT00446199|E3|Reported Event|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle)
630401|NCT00446199|E2|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630402|NCT00446199|E1|Reported Event|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
630403|NCT00446147|B3|Baseline|Total|Total of all reporting groups
630404|NCT00446147|B2|Baseline|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
630405|NCT00446147|B1|Baseline|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
630406|NCT00446147|P2|Participant Flow|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
630407|NCT00446147|P1|Participant Flow|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
630408|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
630409|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
630410|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
630411|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
630412|NCT00446147|E2|Reported Event|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
630413|NCT00446147|E1|Reported Event|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
630414|NCT00446134|B5|Baseline|Total|Total of all reporting groups
630415|NCT00446134|B4|Baseline|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630416|NCT00446134|B3|Baseline|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630417|NCT00446134|B2|Baseline|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630418|NCT00446134|B1|Baseline|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630419|NCT00446134|P4|Participant Flow|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630420|NCT00446134|P3|Participant Flow|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630421|NCT00446134|P2|Participant Flow|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630422|NCT00446134|P1|Participant Flow|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630423|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630424|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630425|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630426|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630427|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630428|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630429|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630430|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630431|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630432|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630433|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630434|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630435|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630436|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630437|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630438|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630439|NCT00446134|E4|Reported Event|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630440|NCT00446134|E3|Reported Event|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630441|NCT00446134|E2|Reported Event|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630442|NCT00446134|E1|Reported Event|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
630443|NCT00446095|B6|Baseline|Total|Total of all reporting groups
630444|NCT00446095|B5|Baseline|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
630445|NCT00446095|B4|Baseline|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
630446|NCT00446095|B3|Baseline|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
630447|NCT00446095|B2|Baseline|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
630448|NCT00446095|B1|Baseline|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
630449|NCT00446095|P5|Participant Flow|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
630450|NCT00446095|P4|Participant Flow|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
630451|NCT00446095|P3|Participant Flow|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
630452|NCT00446095|P2|Participant Flow|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
630453|NCT00446095|P1|Participant Flow|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
630454|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
630455|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
630456|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
630457|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
630458|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
630459|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
630460|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
630461|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
630462|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
630463|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
630464|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
630465|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
630466|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
630467|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
630468|NCT00446095|E5|Reported Event|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
630469|NCT00446095|E4|Reported Event|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
630470|NCT00446095|E3|Reported Event|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
630471|NCT00446095|E2|Reported Event|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
630472|NCT00446095|E1|Reported Event|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
630473|NCT00446030|B3|Baseline|Total|Total of all reporting groups
630474|NCT00446030|B2|Baseline|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
630475|NCT00446030|B1|Baseline|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
630476|NCT00446030|P2|Participant Flow|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
630477|NCT00446030|P1|Participant Flow|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
630478|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
630649|NCT00445705|E2|Reported Event|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
630479|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
630480|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
630481|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
630482|NCT00446030|E2|Reported Event|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
630483|NCT00446030|E1|Reported Event|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
630484|NCT00445939|B4|Baseline|Total|Total of all reporting groups
630485|NCT00445939|B3|Baseline|Placebo|Placebo at Week 0, placebo Week 2
630486|NCT00445939|B2|Baseline|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
630487|NCT00445939|B1|Baseline|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
630488|NCT00445939|P4|Participant Flow|Adalimumab 40mg /40 mg|Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.
630489|NCT00445939|P3|Participant Flow|Placebo|Placebo at Week 0, placebo at Week 2
630490|NCT00445939|P2|Participant Flow|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
630491|NCT00445939|P1|Participant Flow|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
630492|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
630493|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
630494|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
630495|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, adalimumab 160 mg at Week 4, and adalimumab 80 mg at Week 6
630496|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
630497|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
630498|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2,
630499|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
630500|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
630501|NCT00445939|O3|Outcome|Placebo + 160/80 mg|Placebo at Week 0, placebo at Week 2
630502|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
630503|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
630504|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2
630505|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
630506|NCT00445939|O1|Outcome|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
630507|NCT00445939|E6|Reported Event|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
630508|NCT00445939|E5|Reported Event|80/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
630509|NCT00445939|E4|Reported Event|Adalimumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
630510|NCT00445939|E3|Reported Event|Placebo|Placebo at Week 0, placebo at Week 2
630511|NCT00445939|E2|Reported Event|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
630512|NCT00445939|E1|Reported Event|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
630513|NCT00445887|B3|Baseline|Total|Total of all reporting groups
630514|NCT00445887|B2|Baseline|Arm II (Placebo)|Placebo for 4 to 6 weeks
630515|NCT00445887|B1|Baseline|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
630516|NCT00445887|P2|Participant Flow|Arm II (Placebo)|Placebo for 4 to 6 weeks
630517|NCT00445887|P1|Participant Flow|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
630518|NCT00445887|O2|Outcome|Arm II (Placebo)|Placebo for 4 to 6 weeks
630519|NCT00445887|O1|Outcome|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
630520|NCT00445887|O2|Outcome|Arm II (Placebo)|Placebo for 4 to 6 weeks
630521|NCT00445887|O1|Outcome|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
630522|NCT00445887|O2|Outcome|Arm II (Placebo)|Placebo for 4 to 6 weeks
630523|NCT00445887|O1|Outcome|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
630524|NCT00445887|O10|Outcome|Grade 5 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 5 event using CTCAE 3.0
630525|NCT00445887|O9|Outcome|Grade 4 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 4 event using CTCAE 3.0
630526|NCT00445887|O8|Outcome|Grade 3 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 3 event using CTCAE 3.0
630527|NCT00445887|O7|Outcome|Grade 2 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 2 event using CTCAE 3.0
630528|NCT00445887|O6|Outcome|Grade 1 CTCAE 3.0 Arm II (Placebo)|Number of patients on arm II who experienced a grade 1 event using CTCAE v.30
630650|NCT00445705|E1|Reported Event|Placebo|Part A: Placebo every 12 hours for 4 weeks
630529|NCT00445887|O5|Outcome|Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)|Number of patients on arm I who experienced a grade 5 event using CTCAE v. 3.0
630530|NCT00445887|O4|Outcome|Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)|Number of patients on arm ! who experienced a grade 4 event using CTCAE v. 3.0
630531|NCT00445887|O3|Outcome|Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)|Number of patients on arm 1 who experienced a grade 3 event using CTCAE v 3.0
630532|NCT00445887|O2|Outcome|Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)|Number of patients on arm 1 who experienced a grade 2 event using CTCAE v 3.0
630533|NCT00445887|O1|Outcome|Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)|Number of patients on arm 1 who experienced a grade 1 event using CTCAE v 3.0
630534|NCT00445887|O2|Outcome|Arm II (Placebo)|Placebo for 4 to 6 weeks
630535|NCT00445887|O1|Outcome|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
630536|NCT00445887|E2|Reported Event|Arm II (Placebo)|Placebo for 4 to 6 weeks
630537|NCT00445887|E1|Reported Event|Arm I (Levenorgestrel)|Levenorgestrel (0.15 mg/day) for 4 to 6 weeks for 4 to 6 weeks
630538|NCT00445848|B1|Baseline|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
630539|NCT00445848|P1|Participant Flow|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
630540|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
630541|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
630542|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
630543|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
630544|NCT00445848|E1|Reported Event|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
630545|NCT00445770|B4|Baseline|Total|Total of all reporting groups
630546|NCT00445770|B3|Baseline|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630547|NCT00445770|B2|Baseline|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630548|NCT00445770|B1|Baseline|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630549|NCT00445770|P3|Participant Flow|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630550|NCT00445770|P2|Participant Flow|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630551|NCT00445770|P1|Participant Flow|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630552|NCT00445770|O2|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630553|NCT00445770|O1|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630554|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630555|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630556|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630557|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630558|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630559|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630560|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630561|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630562|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630563|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630564|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630565|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630566|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630567|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630568|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630569|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630570|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630571|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630572|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630687|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630573|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630574|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630575|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630576|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630577|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630578|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630579|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630580|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630581|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630582|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630583|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630584|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630585|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630586|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630587|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630588|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630589|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630590|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630591|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630592|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630593|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630594|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630595|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630596|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630597|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630598|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630599|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630600|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630601|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630602|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630603|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630604|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630605|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630606|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630607|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630608|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630609|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630610|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630611|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630612|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630613|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630614|NCT00445770|E3|Reported Event|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
630688|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630615|NCT00445770|E2|Reported Event|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
630616|NCT00445770|E1|Reported Event|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
630617|NCT00445744|B1|Baseline|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
630618|NCT00445744|P1|Participant Flow|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
630619|NCT00445744|O1|Outcome|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
630620|NCT00445744|O1|Outcome|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
630621|NCT00445744|E1|Reported Event|Treatment (Cyclophosphamide, Busulfan, Transplant)|"CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11.~cyclophosphamide: Given IV~busulfan: Given IV~tacrolimus: Given IV or PO~methotrexate: Given IV~cytogenetic analysis: Correlative studies~flow cytometry: Correlative studies~pharmacological study: Correlative studies~pharmacogenomic studies: Correlative studies~peripheral blood stem cell transplantation: Undergo PBPC transplantation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation"
630622|NCT00445705|B5|Baseline|Total|Total of all reporting groups
630623|NCT00445705|B4|Baseline|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
630624|NCT00445705|B3|Baseline|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
630625|NCT00445705|B2|Baseline|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
630626|NCT00445705|B1|Baseline|Placebo|Part A: Placebo every 12 hours for 4 weeks
630627|NCT00445705|P4|Participant Flow|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
630628|NCT00445705|P3|Participant Flow|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
630629|NCT00445705|P2|Participant Flow|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
630630|NCT00445705|P1|Participant Flow|Placebo|Part A: Placebo every 12 hours for 4 weeks
630631|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
630632|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
630633|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
630634|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
630635|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
630636|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
630637|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
630638|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
630639|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
630640|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
630641|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
630642|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
630643|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
630644|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
630645|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
630646|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
649756|NCT00402987|O4|Outcome|Placebo|
630651|NCT00445692|B1|Baseline|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
630652|NCT00445692|P1|Participant Flow|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
630653|NCT00445692|O1|Outcome|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
630654|NCT00445692|O1|Outcome|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
630655|NCT00445692|O1|Outcome|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
630656|NCT00445692|E1|Reported Event|Treatment (Clarithromycin, Dexamethasone, Lenalidomide)|"Patients receive clarithromycin PO BID and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO QD on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.~NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.~Clarithromycin: Given PO~Dexamethasone: Given PO~Lenalidomide: Given PO"
630657|NCT00445679|B5|Baseline|Total|Total of all reporting groups
630658|NCT00445679|B4|Baseline|Paroxetine 20|Paroxetine 20 mg/day
630659|NCT00445679|B3|Baseline|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630660|NCT00445679|B2|Baseline|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630661|NCT00445679|B1|Baseline|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630662|NCT00445679|P4|Participant Flow|Paroxetine 20|Paroxetine 20 mg/day
630663|NCT00445679|P3|Participant Flow|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630664|NCT00445679|P2|Participant Flow|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630665|NCT00445679|P1|Participant Flow|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630666|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
630667|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630668|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630669|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630670|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
630671|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630672|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630673|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630674|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
630675|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630676|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630677|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630678|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
630679|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630680|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630681|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630682|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
630683|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630684|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630685|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630686|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
649757|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
630692|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630693|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630694|NCT00445679|E4|Reported Event|Paroxetine 20|Paroxetine 20 mg/day
630695|NCT00445679|E3|Reported Event|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
630696|NCT00445679|E2|Reported Event|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
630697|NCT00445679|E1|Reported Event|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
630698|NCT00445601|B3|Baseline|Total|Total of all reporting groups
630699|NCT00445601|B2|Baseline|Arm II|"Patients receive intravesical placebo over 1 hour post-TURBT.~placebo: Given intravesically"
630700|NCT00445601|B1|Baseline|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.~gemcitabine hydrochloride: Given intravesically"
630701|NCT00445601|P2|Participant Flow|Arm II|"Patients receive intravesical placebo over 1 hour post-TURBT.~placebo: Given intravesically"
630702|NCT00445601|P1|Participant Flow|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.~gemcitabine hydrochloride: Given intravesically"
630703|NCT00445601|O2|Outcome|Arm II: Placebo|Patients receive intravesical placebo over 1 hour post -TURBT.
630704|NCT00445601|O1|Outcome|Arm I: Gemcitabine|Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.
630705|NCT00445601|O2|Outcome|Arm II: Placebo|Patients receive intravesical placebo over 1 hour post -TURBT.
630706|NCT00445601|O1|Outcome|Arm I: Gemcitabine|Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.
630707|NCT00445601|O2|Outcome|Arm II|"Patients receive intravesical placebo over 1 hour post-TURBT.~placebo: Given intravesically"
630708|NCT00445601|O1|Outcome|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.~gemcitabine hydrochloride: Given intravesically"
630709|NCT00445601|O2|Outcome|Arm II|"Patients receive intravesical placebo over 1 hour.~placebo: Given intravesically"
630710|NCT00445601|O1|Outcome|Arm I|"Patients receive intravesical gemcitabine hydrochloride over 1 hour.~gemcitabine hydrochloride: Given intravesically"
630711|NCT00445601|E2|Reported Event|Arm II: Placebo|Patients receive intravesical placebo over 1 hour post-TURBT.
630712|NCT00445601|E1|Reported Event|Arm I: Gemcitabine|Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.
630713|NCT00445588|B1|Baseline|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
630714|NCT00445588|P1|Participant Flow|Treatment|"Patients receive oral erlotinib hydrochloride 150 mg once daily and oral sorafenib tosylate 400 mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
630715|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
630716|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
630717|NCT00445588|E1|Reported Event|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
630718|NCT00445549|B1|Baseline|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
630719|NCT00445549|P1|Participant Flow|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
630720|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
630721|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
630722|NCT00445549|E1|Reported Event|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
630723|NCT00445484|B3|Baseline|Total|Total of all reporting groups
630724|NCT00445484|B2|Baseline|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630725|NCT00445484|B1|Baseline|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630726|NCT00445484|P2|Participant Flow|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630727|NCT00445484|P1|Participant Flow|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
631027|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
630728|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630729|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630730|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630731|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630732|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630733|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630734|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630735|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630736|NCT00445484|E2|Reported Event|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630737|NCT00445484|E1|Reported Event|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
630738|NCT00445458|B5|Baseline|Total|Total of all reporting groups
630739|NCT00445458|B4|Baseline|Arm B Neratinib 240 mg + Paclitaxel|Neratinib 240 mg + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease
630740|NCT00445458|B3|Baseline|Arm A Neratinib 240 mg + Paclitaxel|Neratinib 240 mg + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease
630741|NCT00445458|B2|Baseline|Neratinib 240 mg + Paclitaxel 80 mg/m2|Neratinib 240 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
630742|NCT00445458|B1|Baseline|Neratinib 160 mg + Paclitaxel 80 mg/m2|Neratinib 160 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
630743|NCT00445458|P4|Participant Flow|Arm B Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
630744|NCT00445458|P3|Participant Flow|Arm A Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
630745|NCT00445458|P2|Participant Flow|Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630746|NCT00445458|P1|Participant Flow|Neratinib 160 mg + Paclitaxel 80 mg/m²|Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630747|NCT00445458|O2|Outcome|Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630748|NCT00445458|O1|Outcome|Neratinib 160 mg + Paclitaxel 80 mg/m²|Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630749|NCT00445458|O2|Outcome|Neratinib 240mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630750|NCT00445458|O1|Outcome|Neratinib 160mg + Paclitaxel 80 mg/m²|Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630751|NCT00445458|O2|Outcome|Arm B Neratinib 240 mg + Paclitaxel|Neratinib 240 mg + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimens for metastatic disease.
630752|NCT00445458|O1|Outcome|Arm A Neratinib 240 mg + Paclitaxel|Neratinib 240 mg + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
631558|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
630753|NCT00445458|O1|Outcome|Part 1. Neratinib + Paclitaxel 80 mg/m²|Daily Administration of Neratinib in combination with Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630754|NCT00445458|O2|Outcome|Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630755|NCT00445458|O1|Outcome|Neratinib 160 mg + Paclitaxel 80 mg/m²|Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
630756|NCT00445458|E4|Reported Event|Arm B Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
630757|NCT00445458|E3|Reported Event|Arm A Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
630758|NCT00445458|E2|Reported Event|Neratinib 240 mg + Paclitaxel 80 mg/m²|Neratinib 240 mg qd + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle.
630759|NCT00445458|E1|Reported Event|Neratinib 160 mg + Paclitaxel 80 mg/m²|Neratinib 160 mg qd + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle.
630760|NCT00445432|B4|Baseline|Total|Total of all reporting groups
630761|NCT00445432|B3|Baseline|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
630762|NCT00445432|B2|Baseline|Placebo Eow|Double-blind adalimumab placebo every other week
630763|NCT00445432|B1|Baseline|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630764|NCT00445432|P4|Participant Flow|Any Adalimumab|All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630765|NCT00445432|P3|Participant Flow|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
630766|NCT00445432|P2|Participant Flow|Placebo Eow|Double-blind adalimumab placebo every other week
630767|NCT00445432|P1|Participant Flow|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630768|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630769|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630770|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630771|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630772|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630773|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630774|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630775|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630776|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630777|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630778|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630779|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630780|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630781|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630782|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630783|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630784|NCT00445432|O1|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
630785|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630786|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630787|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
630788|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630789|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630790|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
630791|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630792|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630793|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
630794|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630795|NCT00445432|E4|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
630796|NCT00445432|E3|Reported Event|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
630797|NCT00445432|E2|Reported Event|Placebo Eow|Double-blind adalimumab placebo every other week
630798|NCT00445432|E1|Reported Event|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
630799|NCT00445341|B1|Baseline|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
630800|NCT00445341|P1|Participant Flow|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
630801|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
630802|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
630803|NCT00445341|E1|Reported Event|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
630804|NCT00445328|B3|Baseline|Total|Total of all reporting groups
630805|NCT00445328|B2|Baseline|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630806|NCT00445328|B1|Baseline|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630807|NCT00445328|P2|Participant Flow|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630808|NCT00445328|P1|Participant Flow|Dalteparin|5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
630809|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630810|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630811|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630812|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630813|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630814|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630815|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630816|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630817|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630818|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630819|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630820|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630821|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630822|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630823|NCT00445328|E2|Reported Event|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
630824|NCT00445328|E1|Reported Event|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
630825|NCT00445315|B6|Baseline|Total|Total of all reporting groups
630826|NCT00445315|B5|Baseline|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630827|NCT00445315|B4|Baseline|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630828|NCT00445315|B3|Baseline|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630829|NCT00445315|B2|Baseline|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630830|NCT00445315|B1|Baseline|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630831|NCT00445315|P5|Participant Flow|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630832|NCT00445315|P4|Participant Flow|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630833|NCT00445315|P3|Participant Flow|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630834|NCT00445315|P2|Participant Flow|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630835|NCT00445315|P1|Participant Flow|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630836|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630837|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630838|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630839|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630840|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630841|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630842|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630843|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630844|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630845|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630846|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630847|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630848|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630849|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630850|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630851|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630852|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630853|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630854|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630855|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630856|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630857|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630858|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630859|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630860|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630861|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630862|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630863|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630864|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630865|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630866|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630867|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630868|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630869|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630870|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630871|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630872|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630873|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630874|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630875|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630876|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630877|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630878|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630879|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630880|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630881|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630882|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630883|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630884|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630885|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630886|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630887|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630888|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630889|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630890|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630891|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630892|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630893|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630894|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630895|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630896|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630897|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630898|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630899|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630900|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630901|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630902|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630903|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630904|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630905|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630906|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630907|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630908|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630909|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630910|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630911|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630912|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630913|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630914|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630915|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630916|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630917|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630918|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630919|NCT00445315|E5|Reported Event|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
630920|NCT00445315|E4|Reported Event|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630921|NCT00445315|E3|Reported Event|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
630922|NCT00445315|E2|Reported Event|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630923|NCT00445315|E1|Reported Event|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
630924|NCT00445302|B5|Baseline|Total|Total of all reporting groups
630993|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630925|NCT00445302|B4|Baseline|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630926|NCT00445302|B3|Baseline|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630927|NCT00445302|B2|Baseline|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630928|NCT00445302|B1|Baseline|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630929|NCT00445302|P4|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630930|NCT00445302|P3|Participant Flow|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630931|NCT00445302|P2|Participant Flow|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630932|NCT00445302|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630933|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630934|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630935|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630936|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630937|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630938|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630939|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630940|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630941|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630942|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630943|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630944|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630945|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630946|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630947|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630948|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630949|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630950|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630951|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630952|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630953|NCT00445302|E4|Reported Event|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
631025|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
630954|NCT00445302|E3|Reported Event|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630955|NCT00445302|E2|Reported Event|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630956|NCT00445302|E1|Reported Event|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
630957|NCT00445263|B3|Baseline|Total|Total of all reporting groups
630958|NCT00445263|B2|Baseline|Delayed Invasive Strategy|Coronarography after six hours
630959|NCT00445263|B1|Baseline|Early Invasive Strategy|Tirofiban and coronarography within six hours
630960|NCT00445263|P2|Participant Flow|Delayed Invasive Strategy|Coronarography after six hours
630961|NCT00445263|P1|Participant Flow|Early Invasive Strategy|Tirofiban and coronarography within six hours
630962|NCT00445263|O2|Outcome|Delayed Invasive Strategy|Coronarography after six hours
630963|NCT00445263|O1|Outcome|Early Invasive Strategy|Tirofiban and coronarography within six hours
630964|NCT00445263|E2|Reported Event|Delayed Invasive Strategy|Coronarography after six hours
630965|NCT00445263|E1|Reported Event|Early Invasive Strategy|Tirofiban and coronarography within six hours
630966|NCT00445224|B3|Baseline|Total|Total of all reporting groups
630967|NCT00445224|B2|Baseline|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630968|NCT00445224|B1|Baseline|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630969|NCT00445224|P2|Participant Flow|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630970|NCT00445224|P1|Participant Flow|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630971|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630972|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630973|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630974|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630975|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630976|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630977|NCT00445224|E2|Reported Event|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630978|NCT00445224|E1|Reported Event|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
630979|NCT00445211|B3|Baseline|Total|Total of all reporting groups
630980|NCT00445211|B2|Baseline|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
630981|NCT00445211|B1|Baseline|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630982|NCT00445211|P2|Participant Flow|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
630983|NCT00445211|P1|Participant Flow|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630984|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
630985|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630986|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
630987|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630988|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
630989|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630990|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
630991|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630992|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
631026|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
630994|NCT00445211|E2|Reported Event|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
630995|NCT00445211|E1|Reported Event|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
630996|NCT00445146|B1|Baseline|EVG+RTV|EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.
630997|NCT00445146|P1|Participant Flow|EVG+RTV|"Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
630998|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
630999|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631000|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631001|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631002|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631003|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631004|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631005|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631006|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631007|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631008|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631009|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631010|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631011|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631012|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631013|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631014|NCT00445146|E1|Reported Event|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
631015|NCT00445003|B4|Baseline|Total|Total of all reporting groups
631016|NCT00445003|B3|Baseline|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631017|NCT00445003|B2|Baseline|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631018|NCT00445003|B1|Baseline|Sham Injection|Sham injection at baseline and 4 weeks
631019|NCT00445003|P3|Participant Flow|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631020|NCT00445003|P2|Participant Flow|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631021|NCT00445003|P1|Participant Flow|Sham Injection|Sham injection at baseline and 4 weeks
631022|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631023|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631024|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
631028|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631029|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631030|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
631031|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631032|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631033|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
631034|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631035|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631036|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
631037|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631038|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631039|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
631040|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631041|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631042|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
631043|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631044|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631045|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
631046|NCT00445003|E3|Reported Event|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
631047|NCT00445003|E2|Reported Event|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
631048|NCT00445003|E1|Reported Event|Sham Injection|Sham injection at baseline and 4 weeks
631049|NCT00444951|B4|Baseline|Total|Total of all reporting groups
631050|NCT00444951|B3|Baseline|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
631051|NCT00444951|B2|Baseline|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
631052|NCT00444951|B1|Baseline|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
631053|NCT00444951|P3|Participant Flow|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
631054|NCT00444951|P2|Participant Flow|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
631055|NCT00444951|P1|Participant Flow|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
631056|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
631057|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
631058|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
631059|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
631060|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
631061|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
631062|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
631063|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
631064|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
633072|NCT00441090|B1|Baseline|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
631065|NCT00444951|E3|Reported Event|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
631066|NCT00444951|E2|Reported Event|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
631067|NCT00444951|E1|Reported Event|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
631068|NCT00444925|B4|Baseline|Total|Total of all reporting groups
631069|NCT00444925|B3|Baseline|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631070|NCT00444925|B2|Baseline|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631071|NCT00444925|B1|Baseline|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631072|NCT00444925|P3|Participant Flow|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631073|NCT00444925|P2|Participant Flow|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631074|NCT00444925|P1|Participant Flow|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631075|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631076|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631077|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631078|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631079|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631080|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631081|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631082|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631083|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631084|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631085|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631086|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631087|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631088|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631089|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631090|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631091|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631092|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631093|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631094|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631095|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631096|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631097|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631098|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631099|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631100|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631101|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631102|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631103|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631104|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631105|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631106|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631153|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631107|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631108|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631109|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631110|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631111|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631112|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631113|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631114|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631115|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631116|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631117|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631118|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631119|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631120|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631121|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631122|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631123|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631124|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631125|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631126|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631127|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631128|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631129|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631130|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631131|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631132|NCT00444925|E3|Reported Event|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
631133|NCT00444925|E2|Reported Event|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
631134|NCT00444925|E1|Reported Event|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
631135|NCT00444912|B3|Baseline|Total|Total of all reporting groups
631136|NCT00444912|B2|Baseline|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631137|NCT00444912|B1|Baseline|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631138|NCT00444912|P2|Participant Flow|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631139|NCT00444912|P1|Participant Flow|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631140|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631141|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631142|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631143|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631144|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631145|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631146|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631147|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631148|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631149|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631150|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631151|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631152|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631154|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631155|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631156|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631157|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631158|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631159|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631160|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631161|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631162|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631163|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631164|NCT00444912|E2|Reported Event|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
631165|NCT00444912|E1|Reported Event|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
631166|NCT00444821|B3|Baseline|Total|Total of all reporting groups
631167|NCT00444821|B2|Baseline|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
631168|NCT00444821|B1|Baseline|Surveillance|Subjects were assigned to serial ultrasound surveillance
631169|NCT00444821|P2|Participant Flow|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
631170|NCT00444821|P1|Participant Flow|Surveillance|Subjects were assigned to serial ultrasound surveillance
631171|NCT00444821|O2|Outcome|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
631172|NCT00444821|O1|Outcome|Surveillance|Subjects were assigned to serial ultrasound surveillance
631173|NCT00444821|O2|Outcome|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
631174|NCT00444821|O1|Outcome|Surveillance|Subjects were assigned to serial ultrasound surveillance
631175|NCT00444821|O2|Outcome|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
631176|NCT00444821|O1|Outcome|Surveillance|Subjects were assigned to serial ultrasound surveillance
631177|NCT00444821|E2|Reported Event|Early Endovascular Repair|AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
631178|NCT00444821|E1|Reported Event|Surveillance|Subjects were assigned to serial ultrasound surveillance
631179|NCT00444795|B1|Baseline|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
631180|NCT00444795|P1|Participant Flow|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
631181|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
631182|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
631183|NCT00444795|E1|Reported Event|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
631184|NCT00444626|B1|Baseline|Combined Arms|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
631185|NCT00444626|P1|Participant Flow|Combined Arm|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
631186|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
631187|NCT00444626|O2|Outcome|Restylane - Dermal Gel Extra (DGE)|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. In the Repeat Treatment Period, participants received DGE on both sides of their face. This represents the experience with DGE for the side of the face that was originally treated with Restylane.
631188|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
631189|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
631190|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
631555|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
631191|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
631192|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
631193|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
631194|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
631195|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
631196|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
631197|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
631198|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
631199|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
631200|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
631201|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
631202|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
631203|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
631204|NCT00444626|E6|Reported Event|Non-NLF: Repeat Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
631205|NCT00444626|E5|Reported Event|Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
631206|NCT00444626|E4|Reported Event|Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
631207|NCT00444626|E3|Reported Event|Non-NLF: Initial Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment.
631208|NCT00444626|E2|Reported Event|Restylane: Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment.
631209|NCT00444626|E1|Reported Event|Dermal Gel Extra (DGE): Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment.
631210|NCT00444600|B5|Baseline|Total|Total of all reporting groups
631211|NCT00444600|B4|Baseline|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631212|NCT00444600|B3|Baseline|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631213|NCT00444600|B2|Baseline|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631214|NCT00444600|B1|Baseline|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631215|NCT00444600|P4|Participant Flow|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631216|NCT00444600|P3|Participant Flow|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631217|NCT00444600|P2|Participant Flow|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631218|NCT00444600|P1|Participant Flow|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631219|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631220|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631221|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631222|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631223|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631224|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631225|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631226|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631227|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631228|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631229|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631230|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631231|NCT00444600|O3|Outcome|Triamcinolone|
631232|NCT00444600|O2|Outcome|Ranibizumab|
631233|NCT00444600|O1|Outcome|Sham|
631234|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631235|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631236|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631237|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631238|NCT00444600|O3|Outcome|Triamcinolone|
631239|NCT00444600|O2|Outcome|Ranibizumab|
631240|NCT00444600|O1|Outcome|Sham|
631241|NCT00444600|O3|Outcome|Triamcinolone|
631242|NCT00444600|O2|Outcome|Ranibizumab|
631243|NCT00444600|O1|Outcome|Sham|
631244|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631245|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631246|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631247|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631507|NCT00443898|P3|Participant Flow|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
649758|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
631248|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631249|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631250|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631251|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631252|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631253|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631254|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631255|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631256|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631257|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631258|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631259|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631260|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631261|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631262|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631263|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631264|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631265|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631266|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631267|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631268|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631269|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631270|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631508|NCT00443898|P2|Participant Flow|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
649759|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
631271|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631272|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631273|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631274|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631275|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631276|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631277|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631278|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631279|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631280|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631281|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631282|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631283|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631284|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631285|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631286|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631287|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631288|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631289|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631290|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631291|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631292|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631293|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631509|NCT00443898|P1|Participant Flow|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
649760|NCT00402987|O3|Outcome|Placebo|
631294|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631295|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631296|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631297|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
631298|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631299|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
631300|NCT00444600|E7|Reported Event|Sham + Triamcinolone + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
631301|NCT00444600|E6|Reported Event|Sham + Ranibizumab + Deferred Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
631302|NCT00444600|E5|Reported Event|Sham + Ranibizumab + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
631303|NCT00444600|E4|Reported Event|Triamcinolone + Prompt Laser|4 mg intravitreal triamcinolone plus prompt (within 3–10 days after injection) focal/grid photocoagulation
631304|NCT00444600|E3|Reported Event|Ranibizumab + Deferred Laser|0.5 mg intravitreal ranibizumab with deferred (24 weeks) focal/grid photocoagulation
631305|NCT00444600|E2|Reported Event|Ranibizumab + Prompt Laser|0.5 mg intravitreal ranibizumab plus prompt (within 3–10 days after injection) focal/grid photocoagulation
631306|NCT00444600|E1|Reported Event|Sham + Prompt Laser|Laser was given within 3 to 10 days after sham injections, Laser = Focal/grid photocoagulation
631307|NCT00444587|B3|Baseline|Total|Total of all reporting groups
631308|NCT00444587|B2|Baseline|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
631309|NCT00444587|B1|Baseline|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
631310|NCT00444587|P2|Participant Flow|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
631311|NCT00444587|P1|Participant Flow|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab (Herceptin) 6 milligrams per kilograms (mg/kg) of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous (IV) infusion every three weeks until disease progression, unacceptable toxicities, or withdrawal from study, in combination with second line chemotherapy.
631312|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants received second line chemotherapy according to the investigator's decision.
631313|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631314|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631315|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631316|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631317|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
649761|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
631318|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631319|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631320|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631321|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631322|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
631323|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631324|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631325|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631326|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631327|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
631328|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
631329|NCT00444587|E2|Reported Event|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
631330|NCT00444587|E1|Reported Event|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
631331|NCT00444535|B1|Baseline|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
631332|NCT00444535|P1|Participant Flow|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
631333|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
631334|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
631335|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
631336|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
631337|NCT00444535|E1|Reported Event|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
631338|NCT00444457|B5|Baseline|Total|Total of all reporting groups
631339|NCT00444457|B4|Baseline|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631340|NCT00444457|B3|Baseline|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631351|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631341|NCT00444457|B2|Baseline|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631342|NCT00444457|B1|Baseline|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631343|NCT00444457|P4|Participant Flow|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631344|NCT00444457|P3|Participant Flow|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631345|NCT00444457|P2|Participant Flow|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631346|NCT00444457|P1|Participant Flow|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631347|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631348|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631349|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631350|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631352|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631353|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631354|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631355|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631356|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631357|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631358|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631359|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631360|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631361|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631362|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631363|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631364|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631459|NCT00444275|E5|Reported Event|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631365|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631366|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631367|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631368|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631369|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631370|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631371|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631372|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631373|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631374|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
631375|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631376|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631460|NCT00444275|E4|Reported Event|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631461|NCT00444275|E3|Reported Event|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631462|NCT00444275|E2|Reported Event|Esomeprazole 40 mg Once Daily (Initial Phase)|
631463|NCT00444275|E1|Reported Event|Esomeprazole 20 mg Once Daily (Initial Phase)|
631510|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
631556|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
631377|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631378|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631379|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631380|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631381|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631382|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631383|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631384|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631385|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631557|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
631386|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631387|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631388|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631389|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631390|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631391|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631392|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631393|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631394|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631511|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
631395|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631396|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
631397|NCT00444457|E10|Reported Event|Post Toddler Dose 6-Month Follow-up 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
631398|NCT00444457|E9|Reported Event|Post Toddler Dose 6-Month Follow-up Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
631399|NCT00444457|E8|Reported Event|Toddler Dose 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128."
631400|NCT00444457|E7|Reported Event|Toddler Dose Combined 13vPnC|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771."
631401|NCT00444457|E6|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
631402|NCT00444457|E5|Reported Event|After the Infant Series Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
631403|NCT00444457|E4|Reported Event|Infant Series 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198."
631404|NCT00444457|E3|Reported Event|Infant Series 13vPnC (Manufacturing Lot)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386."
631464|NCT00444145|B1|Baseline|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
631512|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
631405|NCT00444457|E2|Reported Event|Infant Series 13vPnC (Pilot Lot 2)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364."
631406|NCT00444457|E1|Reported Event|Infant Series 13vPnC (Pilot Lot 1)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373."
631407|NCT00444275|B4|Baseline|Total|Total of all reporting groups
631408|NCT00444275|B3|Baseline|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631409|NCT00444275|B2|Baseline|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631410|NCT00444275|B1|Baseline|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631411|NCT00444275|P5|Participant Flow|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631412|NCT00444275|P4|Participant Flow|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631413|NCT00444275|P3|Participant Flow|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631414|NCT00444275|P2|Participant Flow|Esomeprazole 40 mg Once Daily (Initial Phase)|
631415|NCT00444275|P1|Participant Flow|Esomeprazole 20 mg Once Daily (Initial Phase)|
631416|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631417|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631418|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631419|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631420|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631421|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631422|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631423|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631424|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631425|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631426|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631427|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631428|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631429|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631430|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631431|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631432|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631433|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631434|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631435|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631436|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631437|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631438|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631439|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631440|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631441|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631442|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631443|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631444|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631445|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631446|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631447|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631448|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631449|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631450|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631451|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631452|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631453|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631454|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
631455|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
631456|NCT00444275|O3|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
631457|NCT00444275|O2|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
631458|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
631554|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
631465|NCT00444145|P1|Participant Flow|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
631466|NCT00444145|O1|Outcome|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
631467|NCT00444145|E1|Reported Event|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
631468|NCT00444106|B4|Baseline|Total|Total of all reporting groups
631469|NCT00444106|B3|Baseline|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
631470|NCT00444106|B2|Baseline|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
631471|NCT00444106|B1|Baseline|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
631472|NCT00444106|P3|Participant Flow|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
631473|NCT00444106|P2|Participant Flow|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
631474|NCT00444106|P1|Participant Flow|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
631475|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
631476|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
631477|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
631478|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
631479|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
631480|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
631481|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
631482|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
631483|NCT00444106|O1|Outcome|Artemether-lumefantrine|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
631484|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
631485|NCT00444106|E3|Reported Event|Artesunate-Mefloquine|Artesunate-Mefloquine
631486|NCT00444106|E2|Reported Event|Atovaquone-proguanil|Atovaquone-proguanil
631487|NCT00444106|E1|Reported Event|Artemether-lumefantrine|Artemether-lumefantrine
631488|NCT00444067|B3|Baseline|Total|Total of all reporting groups
631489|NCT00444067|B2|Baseline|Control|Standard of care methods used as an adjunct to sutured dural repair.
631490|NCT00444067|B1|Baseline|Spinal Sealant|DuraSeal Spinal Sealant System
631491|NCT00444067|P2|Participant Flow|Control|Standard of care methods used as an adjunct to sutured dural repair.
631492|NCT00444067|P1|Participant Flow|Spinal Sealant|DuraSeal Spinal Sealant System
631493|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
631494|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
631495|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
631496|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
631497|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
631498|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
631499|NCT00444067|E2|Reported Event|Control|Standard of care methods used as an adjunct to sutured dural repair.
631500|NCT00444067|E1|Reported Event|Spinal Sealant|DuraSeal Spinal Sealant System
631501|NCT00443898|B5|Baseline|Total|Total of all reporting groups
631502|NCT00443898|B4|Baseline|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
631503|NCT00443898|B3|Baseline|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
631504|NCT00443898|B2|Baseline|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
631505|NCT00443898|B1|Baseline|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
631506|NCT00443898|P4|Participant Flow|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
631513|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
631514|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
631515|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
631516|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
631517|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
631518|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
631519|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
631520|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
631521|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
631522|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
631523|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
631524|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
631525|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
631526|NCT00443898|E4|Reported Event|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
631527|NCT00443898|E3|Reported Event|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
631528|NCT00443898|E2|Reported Event|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
631529|NCT00443898|E1|Reported Event|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
631530|NCT00443872|B1|Baseline|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
631531|NCT00443872|P1|Participant Flow|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
631532|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (MMSE)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
631533|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BAI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
631534|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BDI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
631535|NCT00443872|O1|Outcome|All Subjects PDQ-39|This includes all patients in the study. They all received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks which was increased to 2.5 mg once daily if tolerated.
631536|NCT00443872|O1|Outcome|All Subjects With DA Related AEs (UPDRS Data)|For all completed subjects (60) UPDRS activities of daily living scores and motor scores were collected. All patients received 1.25 mg once daily orally disintegrating selegiline for 6 weeks which was increased to 2.5mg once daily at 12 weeks if tolerated.
631537|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Impulse Control Disorder)|Patients who are experiencing dopamine agonist (DA) related adverse effect (AE) of impulse control disorder (ICD) received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5mg once daily if tolerated.
631538|NCT00443872|O1|Outcome|PD Patiens With DA Related AE (Pedal Edema)|Patients who are experiencing a dopamine agonist (DA) related AE of pedal edema received 1.25mg once daily of orally disintegrating selegiline for 6 weeks after which there was an increase to 2.5 mg once daily if tolerated.
631539|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Hallucinations)|Patients who are experiencing the dopamine agonist (DA) related adverse effect of hallucinations. The participants received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5 mg once daily if tolerated.
631540|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Daytime Sleepiness)|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of daytime sleepiness received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for the remaining 6 weeks if tolerated.
631541|NCT00443872|O1|Outcome|PD Patients With DA Related AE|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of either one or more of the following: excessive daytime sleepiness, hallucinations, pedal edema, impulse control disorder, received 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated.
631542|NCT00443872|E1|Reported Event|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
631543|NCT00443820|B5|Baseline|Total|Total of all reporting groups
631544|NCT00443820|B4|Baseline|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
631545|NCT00443820|B3|Baseline|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
631546|NCT00443820|B2|Baseline|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
631547|NCT00443820|B1|Baseline|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
631548|NCT00443820|P4|Participant Flow|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
631549|NCT00443820|P3|Participant Flow|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
631550|NCT00443820|P2|Participant Flow|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
631551|NCT00443820|P1|Participant Flow|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
631552|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
631553|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
631559|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
631560|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
631561|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
631562|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
631563|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
631564|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
631565|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
631566|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
631567|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
631568|NCT00443820|E4|Reported Event|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
631569|NCT00443820|E3|Reported Event|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
631570|NCT00443820|E2|Reported Event|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
631571|NCT00443820|E1|Reported Event|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
631572|NCT00443781|B1|Baseline|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
631573|NCT00443781|P1|Participant Flow|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
631574|NCT00443781|O1|Outcome|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
631575|NCT00443781|E1|Reported Event|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
631576|NCT00443755|B3|Baseline|Total|Total of all reporting groups
631577|NCT00443755|B2|Baseline|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631578|NCT00443755|B1|Baseline|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631579|NCT00443755|P2|Participant Flow|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631580|NCT00443755|P1|Participant Flow|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631581|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631582|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631583|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631584|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631585|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631586|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631587|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631588|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631589|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631590|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631591|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631806|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
631592|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631593|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631594|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631595|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631596|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631597|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631598|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631599|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631600|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631601|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631602|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631603|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631604|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631605|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631606|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631607|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631608|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631609|NCT00443755|E2|Reported Event|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
631610|NCT00443755|E1|Reported Event|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
631611|NCT00443729|B3|Baseline|Total|Total of all reporting groups
631612|NCT00443729|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631613|NCT00443729|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631614|NCT00443729|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631615|NCT00443729|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631616|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631841|NCT00443261|O1|Outcome|Arm 1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
631617|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631618|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631619|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631620|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631621|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631622|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631623|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631624|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631625|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631626|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631627|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631628|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631629|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631630|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631631|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631632|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631633|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631634|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631635|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631636|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631637|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631842|NCT00443261|E1|Reported Event|1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
631638|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631639|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631640|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631641|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631642|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631643|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631644|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631645|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631646|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631647|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631648|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631649|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631650|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631651|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631652|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631653|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631654|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631655|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631656|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631657|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631658|NCT00443729|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631843|NCT00443209|B3|Baseline|Total|Total of all reporting groups
631659|NCT00443729|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631660|NCT00443703|B3|Baseline|Total|Total of all reporting groups
631661|NCT00443703|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631662|NCT00443703|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631663|NCT00443703|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631664|NCT00443703|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631665|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631666|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631667|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631668|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631669|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631670|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631671|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631672|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631673|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631674|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631675|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631676|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631677|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631678|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631679|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631680|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631681|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631682|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631683|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631684|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631685|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631686|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631687|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631688|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631689|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631690|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631691|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631692|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631693|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631694|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631695|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631696|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631697|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631698|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631699|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631700|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631701|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631860|NCT00443118|B4|Baseline|Total|Total of all reporting groups
631702|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631703|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631704|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631705|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631706|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631707|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631708|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631709|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631710|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631711|NCT00443703|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631712|NCT00443703|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
631713|NCT00443651|B3|Baseline|Total|Total of all reporting groups
631714|NCT00443651|B2|Baseline|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631715|NCT00443651|B1|Baseline|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631716|NCT00443651|P2|Participant Flow|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631717|NCT00443651|P1|Participant Flow|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631718|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631719|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631922|NCT00443053|O2|Outcome|Placebo|Matching placebo
631720|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631721|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631722|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631723|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631724|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631725|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631726|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631727|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631728|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631729|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631730|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631731|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631754|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
649762|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
631732|NCT00443651|E2|Reported Event|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631733|NCT00443651|E1|Reported Event|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
631734|NCT00443599|B3|Baseline|Total|Total of all reporting groups
631735|NCT00443599|B2|Baseline|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
631736|NCT00443599|B1|Baseline|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
631737|NCT00443599|P2|Participant Flow|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
631738|NCT00443599|P1|Participant Flow|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
631739|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631740|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631741|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631742|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631743|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631744|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631745|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631746|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631747|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631748|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631749|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631750|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631751|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631752|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631753|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631755|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631756|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631757|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631758|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631759|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631760|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631761|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631762|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631763|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631764|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631765|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
631766|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
631767|NCT00443599|E2|Reported Event|Usual Care|Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control.
631768|NCT00443599|E1|Reported Event|Insulin|Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
631769|NCT00443560|B3|Baseline|Total|Total of all reporting groups
631770|NCT00443560|B2|Baseline|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
631771|NCT00443560|B1|Baseline|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
631772|NCT00443560|P2|Participant Flow|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
631773|NCT00443560|P1|Participant Flow|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
631774|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
631775|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
631776|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
631777|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
631778|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
631779|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
631780|NCT00443560|E2|Reported Event|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
631781|NCT00443560|E1|Reported Event|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
631782|NCT00443534|B1|Baseline|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
631783|NCT00443534|P1|Participant Flow|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
631784|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
631785|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
631786|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
631787|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
631788|NCT00443534|E1|Reported Event|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
631789|NCT00443456|B1|Baseline|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
631790|NCT00443456|P1|Participant Flow|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
631791|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
631792|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
631793|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
631794|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
631795|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
631796|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
631797|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
631798|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
631799|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
631800|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
631801|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
631802|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
631803|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
631804|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
631805|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
632038|NCT00442689|B2|Baseline|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
631807|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
631808|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
631809|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
631810|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
631811|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
631812|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
631813|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
631814|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
631815|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
631816|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
631817|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
631818|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
631819|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
631820|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
631821|NCT00443456|E1|Reported Event|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study
631822|NCT00443430|B3|Baseline|Total|Total of all reporting groups
631823|NCT00443430|B2|Baseline|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
631824|NCT00443430|B1|Baseline|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
631825|NCT00443430|P2|Participant Flow|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
631826|NCT00443430|P1|Participant Flow|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
631827|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
631828|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
631829|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
631830|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
631831|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
631832|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
631833|NCT00443430|E2|Reported Event|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
631834|NCT00443430|E1|Reported Event|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
631835|NCT00443352|B1|Baseline|Duloxetine Completers|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
631836|NCT00443352|P1|Participant Flow|Duloxetine|Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
631837|NCT00443352|O1|Outcome|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
631838|NCT00443352|E1|Reported Event|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
631839|NCT00443261|B1|Baseline|1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
631840|NCT00443261|P1|Participant Flow|Arm 1: SCCHN|"Intervention:~Azacitidine: SC daily X 5 every 28 days azacitidine at assigned dose ranging from 37 to 110 mg/M^2/day.~Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
649763|NCT00402987|O4|Outcome|Placebo|
631844|NCT00443209|B2|Baseline|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631845|NCT00443209|B1|Baseline|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631846|NCT00443209|P2|Participant Flow|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631847|NCT00443209|P1|Participant Flow|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631848|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631849|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631850|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631851|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631852|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631853|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631854|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631855|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631856|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631857|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631858|NCT00443209|E2|Reported Event|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
631859|NCT00443209|E1|Reported Event|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
631861|NCT00443118|B3|Baseline|Self Inflating Bag Without PEEP|Subjects allocated to Self Inflating Bag without PEEP
631862|NCT00443118|B2|Baseline|Self Inflating Bag With PEEP|Subjects allocated to Self Inflating Bag with PEEP
631863|NCT00443118|B1|Baseline|T-Piece|Subjects assigned to be resuscitated with T-Piece
631864|NCT00443118|P3|Participant Flow|SIB-Without PEEP Valve|Self inflating bag without PEEP valve
631865|NCT00443118|P2|Participant Flow|SIB - With PEEP Valve|Subjects allocated to SIB with a PEEP valve attached
631866|NCT00443118|P1|Participant Flow|T-Piece|Subjects assigned to be resuscitated with T-Piece
631867|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to be resuscitated with Self Inflating Bag Without PEEP valve
631868|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
631869|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631870|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
631871|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Without PEEP valve
631872|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631873|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocate to SIB Without PEEP valve
631874|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
631875|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631876|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
631877|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
631878|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631879|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
631880|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
631881|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631882|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
631883|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
631884|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631885|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Self Inflating Bag without PEEP valve
631886|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
631887|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631888|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag Without PEEP valve
631889|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
631890|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631891|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects Allocated to SIB without PEEP valve
631892|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
631893|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631894|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag without PEEP valve
631895|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with a PEEP valve attached
631896|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631897|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Sujects allocated to be ventilated with Self Inflating Bag Without PEEP valve
631898|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to be ventilated using a Self Inlfating Bag with PEEP valve
631899|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631900|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag withouth a PEEP valve
631901|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
631902|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631903|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve attached
631904|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve attached
631905|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
631906|NCT00443118|E3|Reported Event|SIB Without PEEP|Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve
631907|NCT00443118|E2|Reported Event|SIB - Self Inflating Bag With PEEP|Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve
631908|NCT00443118|E1|Reported Event|T-Piece|Subjects assigned to be resuscitated with T-Piece
631909|NCT00443053|B3|Baseline|Total|Total of all reporting groups
631910|NCT00443053|B2|Baseline|Placebo|Matching placebo
631911|NCT00443053|B1|Baseline|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631912|NCT00443053|P2|Participant Flow|Placebo|Matching placebo
631913|NCT00443053|P1|Participant Flow|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631914|NCT00443053|O2|Outcome|Placebo|Matching placebo
631915|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631916|NCT00443053|O2|Outcome|Placebo|Matching placebo
631917|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631918|NCT00443053|O2|Outcome|Placebo|Matching placebo
631919|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631920|NCT00443053|O2|Outcome|Placebo|Matching placebo
631921|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631923|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631924|NCT00443053|O2|Outcome|Placebo|Matching placebo
631925|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631926|NCT00443053|O2|Outcome|Placebo|Matching placebo
631927|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631928|NCT00443053|E2|Reported Event|Placebo|Matching placebo
631929|NCT00443053|E1|Reported Event|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
631930|NCT00443040|B4|Baseline|Total|Total of all reporting groups
631931|NCT00443040|B3|Baseline|Placebo|Matching Placebo
631932|NCT00443040|B2|Baseline|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
631933|NCT00443040|B1|Baseline|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
631934|NCT00443040|P3|Participant Flow|Placebo|Matching Placebo
631935|NCT00443040|P2|Participant Flow|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
631936|NCT00443040|P1|Participant Flow|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
631937|NCT00443040|O3|Outcome|Placebo|Matching Placebo
631938|NCT00443040|O2|Outcome|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
631939|NCT00443040|O1|Outcome|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
631940|NCT00443040|E3|Reported Event|Placebo|Matching Placebo
631941|NCT00443040|E2|Reported Event|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
631942|NCT00443040|E1|Reported Event|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
631943|NCT00442962|B1|Baseline|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631944|NCT00442962|P1|Participant Flow|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631945|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631946|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631947|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631948|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631949|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631950|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631951|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631952|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631953|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631954|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631955|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631956|NCT00442962|E1|Reported Event|EFV+FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
631957|NCT00442936|B5|Baseline|Total|Total of all reporting groups
631958|NCT00442936|B4|Baseline|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631959|NCT00442936|B3|Baseline|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631960|NCT00442936|B2|Baseline|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631961|NCT00442936|B1|Baseline|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631962|NCT00442936|P4|Participant Flow|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631963|NCT00442936|P3|Participant Flow|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631964|NCT00442936|P2|Participant Flow|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631965|NCT00442936|P1|Participant Flow|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631966|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631967|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631968|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631969|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631970|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631971|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631972|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631973|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631974|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631975|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631976|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631977|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631978|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631979|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631980|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631981|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
632039|NCT00442689|B1|Baseline|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632040|NCT00442689|P3|Participant Flow|Placebo - 3|Placebo only
632041|NCT00442689|P2|Participant Flow|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
631982|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631983|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631984|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631985|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631986|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631987|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631988|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631989|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631990|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631991|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631992|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631993|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631994|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631995|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
631996|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
631997|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
631998|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
632042|NCT00442689|P1|Participant Flow|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
632043|NCT00442689|O3|Outcome|Placebo - 3|Placebo
631999|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
632000|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
632001|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
632002|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
632003|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
632004|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
632005|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
632006|NCT00442936|E4|Reported Event|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
632007|NCT00442936|E3|Reported Event|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
632008|NCT00442936|E2|Reported Event|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
632009|NCT00442936|E1|Reported Event|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
632010|NCT00442897|B3|Baseline|Total|Total of all reporting groups
632011|NCT00442897|B2|Baseline|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
632012|NCT00442897|B1|Baseline|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
632013|NCT00442897|P2|Participant Flow|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
632014|NCT00442897|P1|Participant Flow|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
632015|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
632016|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
632017|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
632044|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632045|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632046|NCT00442689|O3|Outcome|Placebo - 3|Placebo
632047|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632018|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
632019|NCT00442897|E2|Reported Event|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
632020|NCT00442897|E1|Reported Event|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
632021|NCT00442702|B3|Baseline|Total|Total of all reporting groups
632022|NCT00442702|B2|Baseline|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
632023|NCT00442702|B1|Baseline|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
632024|NCT00442702|P2|Participant Flow|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
632025|NCT00442702|P1|Participant Flow|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
632026|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
632027|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
632028|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
632029|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
632030|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
632031|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
632032|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
632033|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
632034|NCT00442702|E2|Reported Event|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
632035|NCT00442702|E1|Reported Event|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
632036|NCT00442689|B4|Baseline|Total|Total of all reporting groups
632037|NCT00442689|B3|Baseline|Placebo - 3|Placebo
632048|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632049|NCT00442689|O3|Outcome|Placebo - 3|Placebo
632050|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632051|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632052|NCT00442689|O3|Outcome|Placebo - 3|Placebo
632053|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632054|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632055|NCT00442689|O3|Outcome|Placebo - 3|Placebo
632056|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632057|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632058|NCT00442689|O3|Outcome|Placebo - 3|Placebo
632059|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632060|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632061|NCT00442689|O3|Outcome|Placebo - 3|Placebo
632062|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632063|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
632064|NCT00442689|E3|Reported Event|Placebo - 3|Placebo only
632065|NCT00442689|E2|Reported Event|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
632066|NCT00442689|E1|Reported Event|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
632067|NCT00442611|B3|Baseline|Total|Total of all reporting groups
632068|NCT00442611|B2|Baseline|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632069|NCT00442611|B1|Baseline|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632070|NCT00442611|P2|Participant Flow|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632071|NCT00442611|P1|Participant Flow|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632072|NCT00442611|O2|Outcome|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632073|NCT00442611|O1|Outcome|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632074|NCT00442611|O2|Outcome|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632075|NCT00442611|O1|Outcome|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632076|NCT00442611|O2|Outcome|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632077|NCT00442611|O1|Outcome|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632078|NCT00442611|O2|Outcome|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632079|NCT00442611|O1|Outcome|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632080|NCT00442611|O2|Outcome|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632081|NCT00442611|O1|Outcome|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632082|NCT00442611|O2|Outcome|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632083|NCT00442611|O1|Outcome|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632084|NCT00442611|E2|Reported Event|IV Fluid|Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632085|NCT00442611|E1|Reported Event|Abatacept|Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
632086|NCT00442598|B4|Baseline|Total|Total of all reporting groups
632087|NCT00442598|B3|Baseline|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632088|NCT00442598|B2|Baseline|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632089|NCT00442598|B1|Baseline|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
632090|NCT00442598|P3|Participant Flow|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632091|NCT00442598|P2|Participant Flow|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632092|NCT00442598|P1|Participant Flow|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
632093|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632094|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632095|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
632096|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
649764|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
632097|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632098|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
632099|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632100|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632101|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
632102|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632103|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632104|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
632105|NCT00442598|E2|Reported Event|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
632106|NCT00442598|E1|Reported Event|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
632107|NCT00442572|B3|Baseline|Total|Total of all reporting groups
632108|NCT00442572|B2|Baseline|No Intervention|Participants were on non- specific anti-viral treatment.
632109|NCT00442572|B1|Baseline|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632110|NCT00442572|P2|Participant Flow|No Intervention|Participants were on non- specific anti-viral treatment.
632111|NCT00442572|P1|Participant Flow|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a (PEGASYS®). Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms (µg) in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously (SC) and followed by 12 weeks period without treatment.
632112|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632113|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632114|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632115|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632116|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632117|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632118|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632119|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632120|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632121|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632122|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632123|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632124|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632125|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632126|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632127|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632128|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632129|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632130|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632178|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632131|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632132|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632133|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632134|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632135|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632136|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632137|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632138|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632139|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632140|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632141|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632142|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632143|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
632144|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
632145|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment..
632146|NCT00442572|E2|Reported Event|No Intervention|Participants were on non- specific anti-viral treatment.
632147|NCT00442572|E1|Reported Event|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
632148|NCT00442559|B3|Baseline|Total|Total of all reporting groups
632149|NCT00442559|B2|Baseline|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632150|NCT00442559|B1|Baseline|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632151|NCT00442559|P2|Participant Flow|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632152|NCT00442559|P1|Participant Flow|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632153|NCT00442559|O4|Outcome|Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632154|NCT00442559|O3|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632155|NCT00442559|O2|Outcome|Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632300|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632156|NCT00442559|O1|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632157|NCT00442559|O4|Outcome|Daytime Asthma Symptom Score at 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632158|NCT00442559|O3|Outcome|Daytime Asthma Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632159|NCT00442559|O2|Outcome|Daytime Asthma Symptom Score at 12 Weeks - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632160|NCT00442559|O1|Outcome|Daytime Asthma Symptom Score at Baseline - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632161|NCT00442559|E2|Reported Event|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632162|NCT00442559|E1|Reported Event|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
632163|NCT00442546|B4|Baseline|Total|Total of all reporting groups
632164|NCT00442546|B3|Baseline|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632165|NCT00442546|B2|Baseline|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632166|NCT00442546|B1|Baseline|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632167|NCT00442546|P3|Participant Flow|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632168|NCT00442546|P2|Participant Flow|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632169|NCT00442546|P1|Participant Flow|Pregabalin (150 Milligrams [mg])|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on Post-Operative Day 1 (POD 1).
632170|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632171|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632172|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632173|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632174|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632175|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632176|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632177|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632416|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
649765|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
632179|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632180|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632181|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632182|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632183|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632184|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632185|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632186|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632187|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632188|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632189|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632190|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632191|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632192|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632193|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632194|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632195|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632196|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632197|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632198|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632199|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632200|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632201|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632202|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632203|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632204|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632205|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632206|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632207|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632208|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632209|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632210|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632211|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632212|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632213|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632214|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632215|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632216|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632217|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632218|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632219|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632220|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632221|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632222|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632223|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632224|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632225|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632226|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632227|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632228|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632229|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632230|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632231|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632232|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632233|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632234|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632235|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632236|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632237|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632238|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632239|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632240|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632241|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632242|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632243|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632244|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632245|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632246|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632247|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632248|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632249|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632250|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632251|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632252|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632253|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632254|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632255|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632256|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632257|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632258|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632259|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632260|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632261|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632262|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632263|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632264|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632265|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632266|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632267|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632268|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632269|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632270|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632271|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632272|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632273|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632274|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632275|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632276|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632277|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632278|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632279|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632280|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632281|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632282|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632283|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632284|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632285|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632286|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632287|NCT00442546|E3|Reported Event|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
632288|NCT00442546|E2|Reported Event|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632289|NCT00442546|E1|Reported Event|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
632290|NCT00442507|B1|Baseline|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
632291|NCT00442507|P1|Participant Flow|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
632292|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
632293|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
632294|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
632295|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
632296|NCT00442507|E1|Reported Event|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
632297|NCT00442468|B1|Baseline|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632298|NCT00442468|P1|Participant Flow|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632299|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632543|NCT00441727|P3|Participant Flow|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
632301|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632302|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632303|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632304|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632305|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632306|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632307|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632308|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632309|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632310|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632311|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632312|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632313|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632314|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632315|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632316|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632317|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632318|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632319|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632320|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632321|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632322|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632323|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632324|NCT00442468|E1|Reported Event|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
632325|NCT00442416|B3|Baseline|Total|Total of all reporting groups
632326|NCT00442416|B2|Baseline|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632327|NCT00442416|B1|Baseline|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632328|NCT00442416|P2|Participant Flow|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632329|NCT00442416|P1|Participant Flow|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632330|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632331|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632332|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632333|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632334|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632335|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632336|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632337|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632338|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632339|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632340|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632341|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632417|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632342|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632343|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632344|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632345|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632346|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632347|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632348|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632349|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632350|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632351|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632352|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632353|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632354|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632418|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632355|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632356|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632357|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632358|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632359|NCT00442416|E2|Reported Event|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
632360|NCT00442416|E1|Reported Event|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
632361|NCT00442364|B1|Baseline|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
632362|NCT00442364|P1|Participant Flow|Polidocanol 1% Injectable Microfoam|polidocanol injectable microfoam 1%
632363|NCT00442364|O1|Outcome|Safety Evaluable Population|polidocanol injectable foam 1% with circulating MCA bubbles present at MRI
632364|NCT00442364|E1|Reported Event|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
632365|NCT00442351|B3|Baseline|Total|Total of all reporting groups
632366|NCT00442351|B2|Baseline|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
632367|NCT00442351|B1|Baseline|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
632368|NCT00442351|P2|Participant Flow|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
632369|NCT00442351|P1|Participant Flow|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
632370|NCT00442351|O2|Outcome|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
632371|NCT00442351|O1|Outcome|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
632372|NCT00442351|E2|Reported Event|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
632373|NCT00442351|E1|Reported Event|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
632374|NCT00442338|B4|Baseline|Total|Total of all reporting groups
632375|NCT00442338|B3|Baseline|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
632376|NCT00442338|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
632377|NCT00442338|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg IV Administration
632378|NCT00442338|P3|Participant Flow|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
632379|NCT00442338|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
632380|NCT00442338|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg IV Administration
632381|NCT00442338|O3|Outcome|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
632382|NCT00442338|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg IV Administration
632383|NCT00442338|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg IV Administration
632384|NCT00442338|E3|Reported Event|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
632385|NCT00442338|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
632386|NCT00442338|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg IV Administration
632387|NCT00442286|B4|Baseline|Total|Total of all reporting groups
632388|NCT00442286|B3|Baseline|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632419|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632420|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632389|NCT00442286|B2|Baseline|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632390|NCT00442286|B1|Baseline|Roll-In|Subjects that were not included in endpoint analyses
632391|NCT00442286|P2|Participant Flow|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632392|NCT00442286|P1|Participant Flow|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632393|NCT00442286|O2|Outcome|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632394|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632395|NCT00442286|O1|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients active at 30 days post-implant. Excludes roll-in patients.
632396|NCT00442286|O1|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients enrolled in the study. Roll-ins were excluded.
632397|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632398|NCT00442286|O2|Outcome|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632399|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632400|NCT00442286|E2|Reported Event|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632401|NCT00442286|E1|Reported Event|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
632402|NCT00442169|B7|Baseline|Total|Total of all reporting groups
632403|NCT00442169|B6|Baseline|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632404|NCT00442169|B5|Baseline|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
632405|NCT00442169|B4|Baseline|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632406|NCT00442169|B3|Baseline|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632407|NCT00442169|B2|Baseline|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632408|NCT00442169|B1|Baseline|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632409|NCT00442169|P6|Participant Flow|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632410|NCT00442169|P5|Participant Flow|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
632411|NCT00442169|P4|Participant Flow|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632412|NCT00442169|P3|Participant Flow|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632413|NCT00442169|P2|Participant Flow|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632414|NCT00442169|P1|Participant Flow|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632415|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632421|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632422|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
632423|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632424|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632425|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632426|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632427|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632428|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
632429|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632430|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632431|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632432|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632433|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632434|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
632435|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632436|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632437|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632438|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632439|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632440|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
632441|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632442|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632443|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632444|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632445|NCT00442169|E6|Reported Event|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632446|NCT00442169|E5|Reported Event|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
632447|NCT00442169|E4|Reported Event|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632448|NCT00442169|E3|Reported Event|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
632449|NCT00442169|E2|Reported Event|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
632450|NCT00442169|E1|Reported Event|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
632451|NCT00442117|B3|Baseline|Total|Total of all reporting groups
632452|NCT00442117|B2|Baseline|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
632453|NCT00442117|B1|Baseline|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
632454|NCT00442117|P2|Participant Flow|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
632455|NCT00442117|P1|Participant Flow|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
632456|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
632457|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
632458|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
632459|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
632460|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
632461|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
632462|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
632538|NCT00441766|E1|Reported Event|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
632463|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
632464|NCT00442117|E2|Reported Event|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
632465|NCT00442117|E1|Reported Event|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
632466|NCT00442013|B3|Baseline|Total|Total of all reporting groups
632467|NCT00442013|B2|Baseline|Placebo Group|Matching placebo
632468|NCT00442013|B1|Baseline|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632469|NCT00442013|P2|Participant Flow|Placebo Group|Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal
632470|NCT00442013|P1|Participant Flow|Lansoprazole Group|15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal
632471|NCT00442013|O2|Outcome|Placebo Group|matching placebo
632472|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632473|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
632474|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632475|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
632476|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632477|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
632478|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632479|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
632480|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632481|NCT00442013|O2|Outcome|Placebo Group|matching placebo
632482|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632483|NCT00442013|E2|Reported Event|Placebo Group|Matching placebo
632484|NCT00442013|E1|Reported Event|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
632485|NCT00441974|B1|Baseline|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
632486|NCT00441974|P1|Participant Flow|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
632487|NCT00441974|O1|Outcome|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
632488|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
632489|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
632490|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
632491|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
632492|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
632493|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
632494|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
632495|NCT00441974|O3|Outcome|Total|Total of HBeAg+ and HBeAg- participants
632496|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
632497|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
632498|NCT00441974|E1|Reported Event|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
632499|NCT00441792|B3|Baseline|Total|Total of all reporting groups
632500|NCT00441792|B2|Baseline|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
632501|NCT00441792|B1|Baseline|Midazolam|Patients received either etomidate or midazolam.
632502|NCT00441792|P2|Participant Flow|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
632503|NCT00441792|P1|Participant Flow|Midazolam|Patients received either etomidate or midazolam.
632539|NCT00441727|B4|Baseline|Total|Total of all reporting groups
632540|NCT00441727|B3|Baseline|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
632541|NCT00441727|B2|Baseline|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
632542|NCT00441727|B1|Baseline|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632504|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
632505|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
632506|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
632507|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
632508|NCT00441792|E2|Reported Event|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
632509|NCT00441792|E1|Reported Event|Midazolam|Patients received either etomidate or midazolam.
632510|NCT00441766|B5|Baseline|Total|Total of all reporting groups
632511|NCT00441766|B4|Baseline|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
632512|NCT00441766|B3|Baseline|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
632513|NCT00441766|B2|Baseline|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
632514|NCT00441766|B1|Baseline|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
632515|NCT00441766|P4|Participant Flow|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
632516|NCT00441766|P3|Participant Flow|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
632517|NCT00441766|P2|Participant Flow|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
632518|NCT00441766|P1|Participant Flow|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
632519|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
632520|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
632521|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
632522|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
632523|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
632524|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
632525|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
632526|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
632527|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
632528|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
632529|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
632530|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
632531|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
632532|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
632533|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
632534|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
632535|NCT00441766|E4|Reported Event|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
632536|NCT00441766|E3|Reported Event|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
632537|NCT00441766|E2|Reported Event|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
632544|NCT00441727|P2|Participant Flow|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
632545|NCT00441727|P1|Participant Flow|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632546|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
632547|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
632548|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632549|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632550|NCT00441727|O2|Outcome|Esomeproazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (acetylsalicyclic acid) (75-325 mg)
632551|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632552|NCT00441727|O3|Outcome|Placbo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632553|NCT00441727|O2|Outcome|Esomeprazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632554|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632555|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
632556|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
632557|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632558|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
632559|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
632560|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632561|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
632562|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
632563|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632564|NCT00441727|E3|Reported Event|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
632565|NCT00441727|E2|Reported Event|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
632566|NCT00441727|E1|Reported Event|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
632567|NCT00441701|B11|Baseline|Total|Total of all reporting groups
632568|NCT00441701|B10|Baseline|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632569|NCT00441701|B9|Baseline|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632570|NCT00441701|B8|Baseline|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632571|NCT00441701|B7|Baseline|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632572|NCT00441701|B6|Baseline|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632573|NCT00441701|B5|Baseline|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632574|NCT00441701|B4|Baseline|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632575|NCT00441701|B3|Baseline|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632576|NCT00441701|B2|Baseline|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632577|NCT00441701|B1|Baseline|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632578|NCT00441701|P10|Participant Flow|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632579|NCT00441701|P9|Participant Flow|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632580|NCT00441701|P8|Participant Flow|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632581|NCT00441701|P7|Participant Flow|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632582|NCT00441701|P6|Participant Flow|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632583|NCT00441701|P5|Participant Flow|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632584|NCT00441701|P4|Participant Flow|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632585|NCT00441701|P3|Participant Flow|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632586|NCT00441701|P2|Participant Flow|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632587|NCT00441701|P1|Participant Flow|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks
632588|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632589|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632590|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632591|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632592|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632593|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632594|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632595|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632596|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632597|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632598|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632599|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632600|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632601|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632602|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632603|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632604|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632605|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632606|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632607|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632608|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632609|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632610|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632611|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632612|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632613|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632614|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632615|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632616|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632617|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632618|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632619|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632620|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632621|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632622|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632623|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632624|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632625|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632626|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632627|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632628|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632629|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632630|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632631|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632632|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632633|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632634|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632635|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632636|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632637|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632638|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632639|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632640|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632641|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632642|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632643|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632644|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632645|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632646|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632647|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632648|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632649|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632650|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632651|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632652|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632653|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632654|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632655|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632656|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632657|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632658|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632659|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632660|NCT00441701|E8|Reported Event|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632661|NCT00441701|E7|Reported Event|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632662|NCT00441701|E6|Reported Event|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632663|NCT00441701|E5|Reported Event|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632664|NCT00441701|E4|Reported Event|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
632665|NCT00441701|E3|Reported Event|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
632666|NCT00441701|E2|Reported Event|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
632667|NCT00441701|E1|Reported Event|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
632668|NCT00441584|B1|Baseline|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
632669|NCT00441584|P1|Participant Flow|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
632670|NCT00441584|O1|Outcome|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
632671|NCT00441584|E1|Reported Event|PegIntron Plus REBETOL|
632672|NCT00441558|B1|Baseline|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
632673|NCT00441558|P1|Participant Flow|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
632674|NCT00441558|O1|Outcome|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
632675|NCT00441558|E1|Reported Event|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
632676|NCT00441545|B1|Baseline|Entire Study Population|
632733|NCT00441441|P2|Participant Flow|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632768|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632677|NCT00441545|P2|Participant Flow|Sevelamer HCl First|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
632678|NCT00441545|P1|Participant Flow|Fosrenol First|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
632679|NCT00441545|O2|Outcome|Sevelamer HCl|
632680|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
632681|NCT00441545|O2|Outcome|Sevelamer HCl|
632682|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
632683|NCT00441545|O2|Outcome|Sevelamer HCl|
632684|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
632685|NCT00441545|O2|Outcome|Sevelamer HCl|
632686|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
632687|NCT00441545|E2|Reported Event|Sevelamer HCl|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
632688|NCT00441545|E1|Reported Event|Fosrenol|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
632689|NCT00441480|B3|Baseline|Total|Total of all reporting groups
632690|NCT00441480|B2|Baseline|Control|Corn oil
632691|NCT00441480|B1|Baseline|PS-FO|plant sterols esterified to fish oil fatty acids
632692|NCT00441480|P2|Participant Flow|Control|Corn oil
632693|NCT00441480|P1|Participant Flow|PS-FO|plant sterols esterified to fish oil fatty acids
632694|NCT00441480|O2|Outcome|Control|Corn oil
632695|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632696|NCT00441480|O2|Outcome|Control|Corn oil
632697|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632698|NCT00441480|O2|Outcome|Control|Corn oil
632699|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632700|NCT00441480|O2|Outcome|Control|Corn oil
632701|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632702|NCT00441480|O2|Outcome|Control|Corn oil
632703|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632704|NCT00441480|O2|Outcome|Control|Corn oil
632705|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632706|NCT00441480|O2|Outcome|Control|Corn oil
632707|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632708|NCT00441480|O2|Outcome|Control|Corn oil
632709|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632710|NCT00441480|O2|Outcome|Control|Corn oil
632711|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632712|NCT00441480|O2|Outcome|Control|Corn oil
632713|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632714|NCT00441480|O2|Outcome|Control|Corn oil
632715|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632716|NCT00441480|O2|Outcome|Control|Corn oil
632717|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632718|NCT00441480|O2|Outcome|Control|Corn oil
632719|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632720|NCT00441480|O2|Outcome|Control|Corn oil
632721|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
632722|NCT00441480|E2|Reported Event|Control|Corn oil
632723|NCT00441480|E1|Reported Event|PS-FO|plant sterols esterified to fish oil fatty acids
632724|NCT00441467|B1|Baseline|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
632725|NCT00441467|P1|Participant Flow|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
632726|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
632727|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
632728|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
632729|NCT00441467|E1|Reported Event|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
632730|NCT00441441|B3|Baseline|Total|Total of all reporting groups
632731|NCT00441441|B2|Baseline|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632732|NCT00441441|B1|Baseline|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632734|NCT00441441|P1|Participant Flow|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632735|NCT00441441|O2|Outcome|No Spacer|Participants who required a spacer and were in either treatment group
632736|NCT00441441|O1|Outcome|Spacer|Participants who did not use spacer and were in either treatment group
632737|NCT00441441|O2|Outcome|Spacer|Participants who required a spacer and were in either treatment group
632738|NCT00441441|O1|Outcome|No Spacer|Participants who did not use spacer and were in either treatment group
632739|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632740|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632741|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632742|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632743|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632744|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632745|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632746|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632747|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632748|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632749|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632750|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632751|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632752|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632753|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632754|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632755|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
632756|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
632757|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
632758|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
632759|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
632760|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
632761|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
632762|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
632763|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
632764|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
632765|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
632766|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
632767|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632769|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632770|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632771|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632772|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632773|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632774|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632775|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632776|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632777|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632778|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632779|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone propionate 100 µg HFA (2inhalations of 50 µg), twice daily for 12 weeks.
632780|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
632781|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632782|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
632783|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632784|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632785|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632786|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632787|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632788|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632789|NCT00441441|E2|Reported Event|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
632790|NCT00441441|E1|Reported Event|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
632791|NCT00441363|B3|Baseline|Total|Total of all reporting groups
632792|NCT00441363|B2|Baseline|Placebo|matching placebo
632793|NCT00441363|B1|Baseline|Cycloset|0.8 mg tablet
632794|NCT00441363|P2|Participant Flow|Placebo|matching placebo
632795|NCT00441363|P1|Participant Flow|Cycloset|0.8 mg tablet
632796|NCT00441363|O2|Outcome|Placebo|matching placebo
632797|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
632798|NCT00441363|O2|Outcome|Placebo|matching placebo
632799|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
632800|NCT00441363|E2|Reported Event|Placebo|matching placebo
632801|NCT00441363|E1|Reported Event|Cycloset|0.8 mg tablet
632802|NCT00441337|B5|Baseline|Total|Total of all reporting groups
632803|NCT00441337|B4|Baseline|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632804|NCT00441337|B3|Baseline|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632891|NCT00441285|B2|Baseline|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
649766|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
632805|NCT00441337|B2|Baseline|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632806|NCT00441337|B1|Baseline|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632807|NCT00441337|P4|Participant Flow|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632808|NCT00441337|P3|Participant Flow|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632809|NCT00441337|P2|Participant Flow|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632810|NCT00441337|P1|Participant Flow|0.3 mg/kg Nivolumab|0.3 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632811|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632812|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632813|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632814|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632815|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632816|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632957|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632817|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632818|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632819|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632820|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632821|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632822|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632823|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632824|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632825|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632826|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632827|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632828|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632958|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
633073|NCT00441090|P5|Participant Flow|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
649767|NCT00402987|O3|Outcome|Placebo|
632829|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632830|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632831|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632832|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632833|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632834|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632835|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632836|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632837|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632838|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632839|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632840|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632841|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632842|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632843|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632844|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632845|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632846|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632847|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632848|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632849|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632850|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632851|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632852|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632853|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632892|NCT00441285|B1|Baseline|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632854|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632855|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632856|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632857|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632858|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632859|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632860|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632861|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632862|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632863|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632864|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632865|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632917|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632866|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632867|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632868|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632869|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632870|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632871|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632872|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632873|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632874|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632875|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632876|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632877|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632918|NCT00441285|E2|Reported Event|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
633074|NCT00441090|P4|Participant Flow|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
632878|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
632879|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632880|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632881|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632882|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632883|NCT00441337|E4|Reported Event|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632884|NCT00441337|E3|Reported Event|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632885|NCT00441337|E2|Reported Event|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632886|NCT00441337|E1|Reported Event|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
632887|NCT00441285|B6|Baseline|Total|Total of all reporting groups
632888|NCT00441285|B5|Baseline|Phase III Trial Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete the doses to the dosage in the Increased ABZ arm~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
632889|NCT00441285|B4|Baseline|Phase III Trial Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
632890|NCT00441285|B3|Baseline|Phase III Trial ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete to the doses in the Increased ABZ arm~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 10 days."
632956|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632893|NCT00441285|P5|Participant Flow|Phase III Trial - Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Placebo of Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632894|NCT00441285|P4|Participant Flow|Phase III Trial - Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d, for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632895|NCT00441285|P3|Participant Flow|Phase III Trial - ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632896|NCT00441285|P2|Participant Flow|PK Substudy ABZ+Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
632897|NCT00441285|P1|Participant Flow|PK Substudy ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632898|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
632899|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
632900|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
632901|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
632902|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
632903|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
632904|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
632905|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
632906|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
632907|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
632908|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632909|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
632910|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632911|NCT00441285|O2|Outcome|Phenytoin|Area Under the Curve of Praziquantel in Patients Receiving Phenytoin
632912|NCT00441285|O1|Outcome|Carbamazepine|Area Under the Curve of Praziquantel in Patients Receiving Carbamazepine
632913|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg/kg/day, divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg/day, for 10 days.~Praziquantel was given at 50 mg/kg/day, divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g/day,for 9 1/2 days."
632914|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
632915|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632916|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
632919|NCT00441285|E1|Reported Event|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
632920|NCT00441272|B3|Baseline|Total|Total of all reporting groups
632921|NCT00441272|B2|Baseline|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
632922|NCT00441272|B1|Baseline|Placebo|Those participants receiving placebo for 48 weeks
632923|NCT00441272|P2|Participant Flow|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
632924|NCT00441272|P1|Participant Flow|Placebo|Those participants receiving placebo for 48 weeks
632925|NCT00441272|O2|Outcome|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
632926|NCT00441272|O1|Outcome|Placebo|Those participants receiving placebo for 48 weeks
632927|NCT00441272|E2|Reported Event|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
632928|NCT00441272|E1|Reported Event|Placebo|Those participants receiving placebo for 48 weeks
632929|NCT00441259|B3|Baseline|Total|Total of all reporting groups
632930|NCT00441259|B2|Baseline|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632931|NCT00441259|B1|Baseline|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632932|NCT00441259|P2|Participant Flow|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632933|NCT00441259|P1|Participant Flow|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632934|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632935|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632936|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632937|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632938|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632939|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632940|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632941|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632942|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632943|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632944|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632945|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632946|NCT00441259|E2|Reported Event|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
632947|NCT00441259|E1|Reported Event|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
632948|NCT00441168|B3|Baseline|Total|Total of all reporting groups
632949|NCT00441168|B2|Baseline|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632950|NCT00441168|B1|Baseline|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632951|NCT00441168|P2|Participant Flow|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632952|NCT00441168|P1|Participant Flow|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632953|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632954|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632955|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
633075|NCT00441090|P3|Participant Flow|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
632959|NCT00441168|E2|Reported Event|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632960|NCT00441168|E1|Reported Event|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
632961|NCT00441142|B5|Baseline|Total|Total of all reporting groups
632962|NCT00441142|B4|Baseline|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632963|NCT00441142|B3|Baseline|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
632964|NCT00441142|B2|Baseline|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632965|NCT00441142|B1|Baseline|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632966|NCT00441142|P4|Participant Flow|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632967|NCT00441142|P3|Participant Flow|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
632968|NCT00441142|P2|Participant Flow|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632990|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
632991|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633076|NCT00441090|P2|Participant Flow|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633077|NCT00441090|P1|Participant Flow|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
632969|NCT00441142|P1|Participant Flow|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632970|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632971|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
632972|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632973|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632974|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632975|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
632976|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632992|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
632977|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632978|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632979|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
632980|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632981|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632982|NCT00441142|E2|Reported Event|Phase II-Arm A Pts (Control Group): RT + TMZ|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
632983|NCT00441142|E1|Reported Event|Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
632984|NCT00441116|B3|Baseline|Total|Total of all reporting groups
632985|NCT00441116|B2|Baseline|Placebo|Subjects who were given no Investigational product.
632986|NCT00441116|B1|Baseline|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
632987|NCT00441116|P2|Participant Flow|Placebo|Subjects who were given no Investigational product.
632988|NCT00441116|P1|Participant Flow|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
632989|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
632993|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633078|NCT00441090|O5|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
632994|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
632995|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
632996|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
632997|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
632998|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
632999|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633000|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633001|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633002|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633003|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633004|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633005|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633006|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633007|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633008|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633009|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633010|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633011|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633012|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633013|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633014|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633015|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633016|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633017|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633018|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633019|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633020|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633021|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633022|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633023|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633024|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633025|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633026|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633027|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633028|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633029|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633030|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633031|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
649768|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
633032|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633033|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633034|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633035|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633036|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633037|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633038|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633039|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633040|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633041|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633042|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633043|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633044|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633045|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633046|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633047|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633048|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633049|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
633050|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633051|NCT00441116|E2|Reported Event|Placebo|Subjects who were given no Investigational product.
633052|NCT00441116|E1|Reported Event|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
633053|NCT00441103|B3|Baseline|Total|Total of all reporting groups
633054|NCT00441103|B2|Baseline|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
633055|NCT00441103|B1|Baseline|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
633056|NCT00441103|P2|Participant Flow|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
633057|NCT00441103|P1|Participant Flow|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 microgram (mcg) administered subcutaneously three times a week for 40 weeks.
633058|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
633059|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
633060|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
633061|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
633062|NCT00441103|O1|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
633063|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
633064|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
633065|NCT00441103|E2|Reported Event|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
633066|NCT00441103|E1|Reported Event|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
633067|NCT00441090|B6|Baseline|Total|Total of all reporting groups
633068|NCT00441090|B5|Baseline|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633069|NCT00441090|B4|Baseline|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633070|NCT00441090|B3|Baseline|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633071|NCT00441090|B2|Baseline|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633079|NCT00441090|O4|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633080|NCT00441090|O3|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633081|NCT00441090|O2|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633082|NCT00441090|O1|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633083|NCT00441090|O5|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633084|NCT00441090|O4|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633085|NCT00441090|O3|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633086|NCT00441090|O2|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633087|NCT00441090|O1|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633088|NCT00441090|O5|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633089|NCT00441090|O4|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633090|NCT00441090|O3|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633091|NCT00441090|O2|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633092|NCT00441090|O1|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633093|NCT00441090|O5|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633094|NCT00441090|O4|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633095|NCT00441090|O3|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633096|NCT00441090|O2|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633097|NCT00441090|O1|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633098|NCT00441090|O5|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633099|NCT00441090|O4|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633100|NCT00441090|O3|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633101|NCT00441090|O2|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633102|NCT00441090|O1|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633103|NCT00441090|O5|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633104|NCT00441090|O4|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633105|NCT00441090|O3|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633106|NCT00441090|O2|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633107|NCT00441090|O1|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633108|NCT00441090|O5|Outcome|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633109|NCT00441090|O4|Outcome|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633110|NCT00441090|O3|Outcome|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633111|NCT00441090|O2|Outcome|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633112|NCT00441090|O1|Outcome|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633113|NCT00441090|E5|Reported Event|Placebo|3:3:3:3:1 ratio to avatrombopag tablet taken orally once daily for 28 days
633114|NCT00441090|E4|Reported Event|20.0 mg Avatrombopag|20.0 mg tablet taken orally once daily for 28 days
633115|NCT00441090|E3|Reported Event|10.0 mg Avatrombopag|10.0 mg tablet taken orally once daily for 28 days
633116|NCT00441090|E2|Reported Event|5.0 mg Avatrombopag|5.0 mg tablet taken orally once daily for 28 days
633117|NCT00441090|E1|Reported Event|2.5 mg Avatrombopag|2.5 mg tablet taken orally once daily for 28 days
633118|NCT00441064|B3|Baseline|Total|Total of all reporting groups
633119|NCT00441064|B2|Baseline|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
633120|NCT00441064|B1|Baseline|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
633121|NCT00441064|P2|Participant Flow|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and crossed over to the low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
633122|NCT00441064|P1|Participant Flow|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks who crossed over to the high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
633123|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
633124|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
633125|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
633126|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
633127|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
633128|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
633129|NCT00441064|E2|Reported Event|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet.
633130|NCT00441064|E1|Reported Event|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet.
633131|NCT00441012|B3|Baseline|Total|Total of all reporting groups
633132|NCT00441012|B2|Baseline|COMVAX™|"COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)~3 participants in the COMVAX™ group vaccinated but not randomized; overall N is 276, not 273 - due to issues randomizing via IVRS, in violation, all 3 participants were vaccinated as randomly assigned by the Investigator."
633133|NCT00441012|B1|Baseline|Modified Process Vaccine|"Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)~1 participant randomized but not vaccinated in the Modified Process Vaccine group; overall N is 269, not 270."
633134|NCT00441012|P2|Participant Flow|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
633135|NCT00441012|P1|Participant Flow|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
633136|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
633137|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
633138|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
633139|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
633140|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
633141|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
633142|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
633143|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
633144|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
633145|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
633146|NCT00441012|E2|Reported Event|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
633147|NCT00441012|E1|Reported Event|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
633148|NCT00440947|B1|Baseline|ABC/3TC + ATV/r|All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633149|NCT00440947|P5|Participant Flow|ABC/3TC + ATV/r: Extension Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633150|NCT00440947|P4|Participant Flow|ABC/3TC + ATV: Extension Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633151|NCT00440947|P3|Participant Flow|ABC/3TC + ATV/r: Randomization Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633152|NCT00440947|P2|Participant Flow|ABC/3TC + ATV: Randomization Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
633153|NCT00440947|P1|Participant Flow|ABC/3TC + ATV/r: Induction Phase|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633154|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633155|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633156|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633157|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633158|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633159|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633160|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633161|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633162|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633163|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633164|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633165|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633166|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633167|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633168|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633169|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633170|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633171|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633172|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633173|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633285|NCT00440531|B2|Baseline|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
633174|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633175|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633176|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633177|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633178|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633179|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633180|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633181|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633182|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633183|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633184|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633185|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633186|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633187|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633188|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633189|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633190|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633191|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633192|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633193|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633194|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633195|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633196|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
633197|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
633198|NCT00440947|E5|Reported Event|ABC/3TC + ATV/r: Extension Phase|participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
633199|NCT00440947|E4|Reported Event|ABC/3TC + ATV: Extension Phase|Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
633200|NCT00440947|E3|Reported Event|ABC/3TC + ATV/r: Randomization Phase|Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
633201|NCT00440947|E2|Reported Event|ABC/3TC + ATV: Randomization Phase|Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
633202|NCT00440947|E1|Reported Event|ABC/3TC + ATV/r: Induction Phase|Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
633203|NCT00440830|B5|Baseline|Total|Total of all reporting groups
633204|NCT00440830|B4|Baseline|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633205|NCT00440830|B3|Baseline|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633206|NCT00440830|B2|Baseline|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633207|NCT00440830|B1|Baseline|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633208|NCT00440830|P4|Participant Flow|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633209|NCT00440830|P3|Participant Flow|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633210|NCT00440830|P2|Participant Flow|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633211|NCT00440830|P1|Participant Flow|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633212|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633213|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633214|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633215|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633216|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633217|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633218|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633219|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633220|NCT00440830|E4|Reported Event|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633221|NCT00440830|E3|Reported Event|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
633222|NCT00440830|E2|Reported Event|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633223|NCT00440830|E1|Reported Event|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
633224|NCT00440700|B4|Baseline|Total|Total of all reporting groups
633225|NCT00440700|B3|Baseline|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633226|NCT00440700|B2|Baseline|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633227|NCT00440700|B1|Baseline|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633228|NCT00440700|P3|Participant Flow|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633229|NCT00440700|P2|Participant Flow|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633230|NCT00440700|P1|Participant Flow|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633231|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633232|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633233|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633234|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633235|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633236|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633237|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633238|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633239|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633240|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633241|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633242|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633243|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633244|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633286|NCT00440531|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
633245|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633246|NCT00440700|E3|Reported Event|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
633247|NCT00440700|E2|Reported Event|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
633248|NCT00440700|E1|Reported Event|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
633249|NCT00440557|B4|Baseline|Total|Total of all reporting groups
633250|NCT00440557|B3|Baseline|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633251|NCT00440557|B2|Baseline|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633252|NCT00440557|B1|Baseline|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633253|NCT00440557|P3|Participant Flow|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633254|NCT00440557|P2|Participant Flow|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633255|NCT00440557|P1|Participant Flow|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633256|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633257|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633258|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633259|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633260|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633261|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633262|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633263|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633264|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633265|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633266|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633267|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633268|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633269|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633270|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633271|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633272|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633273|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633274|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633275|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633276|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633277|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633278|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633279|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633280|NCT00440557|E3|Reported Event|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
633281|NCT00440557|E2|Reported Event|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
633282|NCT00440557|E1|Reported Event|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
633283|NCT00440531|B4|Baseline|Total|Total of all reporting groups
633284|NCT00440531|B3|Baseline|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
633287|NCT00440531|P3|Participant Flow|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
633288|NCT00440531|P2|Participant Flow|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
633289|NCT00440531|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
633290|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
633291|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
633292|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
633293|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
633294|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
633295|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
633296|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
633297|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
633298|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
633299|NCT00440531|O1|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
633300|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
633301|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
633302|NCT00440518|B4|Baseline|Total|Total of all reporting groups
633303|NCT00440518|B3|Baseline|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633304|NCT00440518|B2|Baseline|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633305|NCT00440518|B1|Baseline|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633306|NCT00440518|P3|Participant Flow|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633307|NCT00440518|P2|Participant Flow|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633308|NCT00440518|P1|Participant Flow|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633309|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633310|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633311|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633312|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633313|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633314|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633315|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633316|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633317|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633318|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633319|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633320|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633321|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633322|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633323|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633324|NCT00440518|E3|Reported Event|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633325|NCT00440518|E2|Reported Event|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
633326|NCT00440518|E1|Reported Event|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
633327|NCT00440505|B1|Baseline|Entire Study Population|
633328|NCT00440505|P6|Participant Flow|Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg|Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
633329|NCT00440505|P5|Participant Flow|Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo|Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
633330|NCT00440505|P4|Participant Flow|Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg|Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
633331|NCT00440505|P3|Participant Flow|Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo|Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
633332|NCT00440505|P2|Participant Flow|Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg|Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
633381|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633382|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633333|NCT00440505|P1|Participant Flow|Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg|Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
633334|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633335|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633336|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
633337|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633338|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633339|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
633340|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633341|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633342|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
633343|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633344|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
633345|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
633346|NCT00440505|E3|Reported Event|Nicotine 10mg|Non-smokers with the Nicotine 10mg patch
633347|NCT00440505|E2|Reported Event|Nicotine 5mg|Non-smokers with the Nicotine 5mg patch
633348|NCT00440505|E1|Reported Event|Placebo|Non-smokers with the placebo patch
633349|NCT00440466|B4|Baseline|Total|Total of all reporting groups
633350|NCT00440466|B3|Baseline|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633351|NCT00440466|B2|Baseline|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633352|NCT00440466|B1|Baseline|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633353|NCT00440466|P3|Participant Flow|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633354|NCT00440466|P2|Participant Flow|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633355|NCT00440466|P1|Participant Flow|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633356|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633357|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633358|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633359|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633360|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633361|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633362|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633363|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633364|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633365|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633366|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633367|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633368|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633369|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633370|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633371|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633372|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633373|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633374|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633375|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633376|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633377|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633378|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633379|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633380|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633554|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
633383|NCT00440466|E3|Reported Event|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
633384|NCT00440466|E2|Reported Event|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
633385|NCT00440466|E1|Reported Event|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
633386|NCT00440401|B3|Baseline|Total|Total of all reporting groups
633387|NCT00440401|B2|Baseline|Standard Treatment|
633388|NCT00440401|B1|Baseline|TachoSil®|
633389|NCT00440401|P2|Participant Flow|Comparator|Standard haemostatic treatment in cardiovascular surgery
633390|NCT00440401|P1|Participant Flow|TachoSil®|Absorbable sponge for intra-operative topical application
633391|NCT00440401|O2|Outcome|Standard Treatment|
633392|NCT00440401|O1|Outcome|TachoSil®|
633393|NCT00440401|O2|Outcome|Standard Treatment|
633394|NCT00440401|O1|Outcome|TachoSil®|
633395|NCT00440401|E2|Reported Event|Standard Treatment|
633396|NCT00440401|E1|Reported Event|TachoSil®|
633397|NCT00440310|B3|Baseline|Total|Total of all reporting groups
633398|NCT00440310|B2|Baseline|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633399|NCT00440310|B1|Baseline|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633400|NCT00440310|P2|Participant Flow|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633401|NCT00440310|P1|Participant Flow|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633402|NCT00440310|O2|Outcome|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633403|NCT00440310|O1|Outcome|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633404|NCT00440310|E2|Reported Event|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633405|NCT00440310|E1|Reported Event|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
633406|NCT00440297|B3|Baseline|Total|Total of all reporting groups
633407|NCT00440297|B2|Baseline|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633408|NCT00440297|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633409|NCT00440297|P2|Participant Flow|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633410|NCT00440297|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633411|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633412|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633413|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633414|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633415|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633416|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633417|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633418|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633419|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633420|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633421|NCT00440297|E2|Reported Event|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
633422|NCT00440297|E1|Reported Event|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
633423|NCT00440271|B3|Baseline|Total|Total of all reporting groups
633424|NCT00440271|B2|Baseline|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633425|NCT00440271|B1|Baseline|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633426|NCT00440271|P2|Participant Flow|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633427|NCT00440271|P1|Participant Flow|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633428|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633429|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633430|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633431|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633432|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633433|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633434|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633435|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633436|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633437|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633438|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633439|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633440|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633441|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633442|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633443|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633444|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633445|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633446|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633447|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633448|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633449|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633450|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633451|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633452|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633453|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633454|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633455|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633456|NCT00440271|E2|Reported Event|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
633457|NCT00440271|E1|Reported Event|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
633458|NCT00440232|B3|Baseline|Total|Total of all reporting groups
633459|NCT00440232|B2|Baseline|Placebo|
633460|NCT00440232|B1|Baseline|Frovatriptan|5.0 mg of Frovatriptan given as single dose
633461|NCT00440232|P2|Participant Flow|Placebo|
633462|NCT00440232|P1|Participant Flow|Frovatriptan|5.0 mg of Frovatriptan given as single dose
633463|NCT00440232|O2|Outcome|Placebo|
633464|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
633465|NCT00440232|O2|Outcome|Placebo|
633466|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
633467|NCT00440232|E2|Reported Event|Placebo|
633468|NCT00440232|E1|Reported Event|Frovatriptan|5.0 mg of Frovatriptan given as single dose
633469|NCT00440193|B3|Baseline|Total|Total of all reporting groups
633470|NCT00440193|B2|Baseline|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633471|NCT00440193|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633472|NCT00440193|P2|Participant Flow|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633473|NCT00440193|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633555|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
633556|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
633474|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633475|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633476|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633477|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633478|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633479|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633480|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633481|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633482|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633483|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633484|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633485|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633486|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633487|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633488|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633489|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633490|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633491|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633492|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633493|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633494|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633495|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633496|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633497|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633498|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633499|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633500|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633501|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633502|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633503|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633623|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
633504|NCT00440193|E2|Reported Event|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
633505|NCT00440193|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
633506|NCT00440180|B3|Baseline|Total|Total of all reporting groups
633507|NCT00440180|B2|Baseline|Anastrozole|1 milligram daily
633508|NCT00440180|B1|Baseline|Placebo|Placebo once daily
633509|NCT00440180|P2|Participant Flow|Anastrozole|1 milligram daily
633510|NCT00440180|P1|Participant Flow|Placebo|Placebo once daily
633511|NCT00440180|O2|Outcome|Anastrozole|1 milligram daily
633512|NCT00440180|O1|Outcome|Placebo|Placebo once daily
633513|NCT00440180|E2|Reported Event|Anastrozole|1 milligram daily
633514|NCT00440180|E1|Reported Event|Placebo|Placebo once daily
633515|NCT00440115|B4|Baseline|Total|Total of all reporting groups
633516|NCT00440115|B3|Baseline|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
633517|NCT00440115|B2|Baseline|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
633518|NCT00440115|B1|Baseline|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
633519|NCT00440115|P3|Participant Flow|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
633520|NCT00440115|P2|Participant Flow|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
633521|NCT00440115|P1|Participant Flow|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
633522|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
633523|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
633524|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
633525|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
633526|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
633527|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
633528|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
633529|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
633530|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
633531|NCT00440115|E3|Reported Event|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
633532|NCT00440115|E2|Reported Event|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
633533|NCT00440115|E1|Reported Event|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
633534|NCT00440050|B3|Baseline|Total|Total of all reporting groups
633535|NCT00440050|B2|Baseline|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
633536|NCT00440050|B1|Baseline|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
633537|NCT00440050|P2|Participant Flow|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
633538|NCT00440050|P1|Participant Flow|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
633539|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
633540|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
633541|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
633542|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
633543|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
633544|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
633545|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
633546|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
633547|NCT00440050|E2|Reported Event|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
633548|NCT00440050|E1|Reported Event|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
633549|NCT00440011|B3|Baseline|Total|Total of all reporting groups
633550|NCT00440011|B2|Baseline|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
633551|NCT00440011|B1|Baseline|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
633552|NCT00440011|P2|Participant Flow|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
633553|NCT00440011|P1|Participant Flow|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
633557|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
633558|NCT00440011|E2|Reported Event|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
633559|NCT00440011|E1|Reported Event|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
633560|NCT00439946|B1|Baseline|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633561|NCT00439946|P1|Participant Flow|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil initiated to deliver a dose 20% higher than the epoprostenol dose on a ng/kg/min basis. IV treprostinil dosing was titrated without restriction during the eight week follow-up period per the investigator's judgment to optimize the dose for symptomatic benefit based on clinical signs / symptoms, exercise capacity and tolerability.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633562|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633563|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633564|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633565|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633566|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633567|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633568|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633569|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633570|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633571|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633572|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633573|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633574|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633575|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633576|NCT00439946|E1|Reported Event|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
633577|NCT00439777|B3|Baseline|Total|Total of all reporting groups
633578|NCT00439777|B2|Baseline|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633579|NCT00439777|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633580|NCT00439777|P2|Participant Flow|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633581|NCT00439777|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633582|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633583|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633584|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633585|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633586|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633624|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
633587|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633588|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633589|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633590|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633591|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633592|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633593|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633594|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633595|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633596|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633597|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633598|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633599|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633600|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633601|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633602|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633603|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633604|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633605|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633606|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633607|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633608|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633609|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633610|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633611|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633612|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633613|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633614|NCT00439777|E2|Reported Event|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
633615|NCT00439777|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
633616|NCT00439738|B3|Baseline|Total|Total of all reporting groups
633617|NCT00439738|B2|Baseline|HCTZ +Amlodipine|
633618|NCT00439738|B1|Baseline|Valsartan/HCTZ (Hydrochlorothiazide)|
633619|NCT00439738|P2|Participant Flow|HCTZ +Amlodipine|
633620|NCT00439738|P1|Participant Flow|Valsartan/HCTZ (Hydrochlorothiazide)|
633621|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
633622|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
633636|NCT00439725|B2|Baseline|Placebo|Participants were to receive matching placebo oral tablet once daily
633637|NCT00439725|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633638|NCT00439725|P2|Participant Flow|Placebo|Participants were to receive matching placebo oral tablet once daily
633639|NCT00439725|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633640|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633641|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633642|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633643|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633644|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633645|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633646|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633647|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633648|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633649|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633650|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633651|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633652|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633653|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633654|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633655|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633656|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633657|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633658|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633659|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633660|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633661|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633662|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633663|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633664|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633665|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633666|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633667|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633668|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633669|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633670|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633671|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633672|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633673|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633674|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633675|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633676|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633677|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633678|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
633679|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633680|NCT00439725|E2|Reported Event|Placebo|Participants were to receive matching placebo oral tablet once daily
633681|NCT00439725|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
633682|NCT00439647|B3|Baseline|Total|Total of all reporting groups
633683|NCT00439647|B2|Baseline|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633684|NCT00439647|B1|Baseline|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633780|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
635279|NCT00435942|O1|Outcome|Relay Device Group|Endovascular Treatment arm
633685|NCT00439647|P2|Participant Flow|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633686|NCT00439647|P1|Participant Flow|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633687|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633688|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633689|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633690|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633691|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633692|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633693|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633694|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633695|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633696|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633697|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633698|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633699|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633700|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633701|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633702|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633703|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633704|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633705|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633706|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633707|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633708|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633709|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633710|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633711|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633712|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633713|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633714|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
633715|NCT00439647|E2|Reported Event|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
633716|NCT00439647|E1|Reported Event|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
633717|NCT00439608|B1|Baseline|Treatment|Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
633718|NCT00439608|P1|Participant Flow|Treatment|"Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer~Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first. Patients were then monitored for 1 h. Paclitaxel was then administered followed by carboplatin. Radiation was generally administered after chemotherapy. Dexamethasone 20 mg intravenously (IV), diphenhydramine 50 mg IV, and ranitidine 50 mg IV were given 30 min before treatment. Dosages of dexamethasone and diphenhydramine could be reduced in subsequent weeks if no hypersensitivity reactions were observed."
633719|NCT00439608|O1|Outcome|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
633720|NCT00439608|E1|Reported Event|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
633721|NCT00439569|B1|Baseline|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633751|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633722|NCT00439569|P1|Participant Flow|Subjects Enrolled|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1. Two new subjects were then enrolled in Cohort 2.
633723|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633724|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633725|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633726|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633727|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633728|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633729|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633730|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
633731|NCT00439569|E1|Reported Event|Cohorts 1 & 2 (500 mg/kg/Day)|Cohort 1 was assigned a dosage of 500 mg/kg/day. One subject was replaced due to an allergic reaction and four subjects due to less than 80 percent study drug compliance. Due to these replacements, more than 3 subjects were enrolled in the first cohort. Cohort 2 was assigned a dosage of 500 mg/kg/day by the MCRM and approved by the SMC due to dose-limiting toxicities experienced in Cohort 1. For the purpose of reporting adverse events, these two cohorts were combined for a total of 9 enrolled subjects.
633732|NCT00439517|B3|Baseline|Total|Total of all reporting groups
633733|NCT00439517|B2|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633734|NCT00439517|B1|Baseline|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633735|NCT00439517|P2|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633736|NCT00439517|P1|Participant Flow|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633737|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633738|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633739|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633740|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633741|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633742|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633743|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633744|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633745|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633746|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633747|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633748|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633749|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633750|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633779|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633752|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633753|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633754|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633755|NCT00439517|E2|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
633756|NCT00439517|E1|Reported Event|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
633757|NCT00439413|B3|Baseline|Total|Total of all reporting groups
633758|NCT00439413|B2|Baseline|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
633759|NCT00439413|B1|Baseline|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
633760|NCT00439413|P2|Participant Flow|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
633761|NCT00439413|P1|Participant Flow|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
633762|NCT00439413|O2|Outcome|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
633763|NCT00439413|O1|Outcome|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
633764|NCT00439413|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
633765|NCT00439413|O1|Outcome|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
633766|NCT00439413|E2|Reported Event|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
633767|NCT00439413|E1|Reported Event|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
633768|NCT00439335|B3|Baseline|Total|Total of all reporting groups
633769|NCT00439335|B2|Baseline|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633770|NCT00439335|B1|Baseline|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633771|NCT00439335|P2|Participant Flow|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633772|NCT00439335|P1|Participant Flow|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633773|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633774|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633775|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633776|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633777|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633778|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633946|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633781|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633782|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633783|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633784|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633785|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633786|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633787|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633788|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633789|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633790|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633791|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633792|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633793|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633794|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633795|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633796|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633797|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633798|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633799|NCT00439335|E2|Reported Event|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
633800|NCT00439335|E1|Reported Event|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
633801|NCT00439309|B3|Baseline|Total|Total of all reporting groups
633802|NCT00439309|B2|Baseline|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633803|NCT00439309|B1|Baseline|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
633804|NCT00439309|P2|Participant Flow|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633805|NCT00439309|P1|Participant Flow|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
633806|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633807|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
635280|NCT00435942|E2|Reported Event|Surgical Control Group|Open Surgical Repair arm
633808|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633809|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
633810|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633811|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
633812|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633813|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
633814|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633815|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
633816|NCT00439309|E2|Reported Event|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
633817|NCT00439309|E1|Reported Event|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
633818|NCT00439270|B6|Baseline|Total|Total of all reporting groups
633819|NCT00439270|B5|Baseline|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633820|NCT00439270|B4|Baseline|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633821|NCT00439270|B3|Baseline|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633822|NCT00439270|B2|Baseline|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633823|NCT00439270|B1|Baseline|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633824|NCT00439270|P5|Participant Flow|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633825|NCT00439270|P4|Participant Flow|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
634075|NCT00438659|B2|Baseline|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
633826|NCT00439270|P3|Participant Flow|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633827|NCT00439270|P2|Participant Flow|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633828|NCT00439270|P1|Participant Flow|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
633829|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633830|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633831|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633832|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633833|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633834|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633835|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633836|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633837|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633838|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633839|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633840|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633841|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633842|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633843|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633844|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633845|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633846|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633847|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633848|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
633849|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633850|NCT00439270|O1|Outcome|All Treated|Participants received dasatinib, 50, 70, 100, or 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 or 75 mg/m^2.
633851|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 (Phase 2 )|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
649769|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
633852|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633853|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633854|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If, for a dose level combination, 2 or more DLTs were observed, the maximum tolerated dose was defined as the previous dose level combination.
633855|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633856|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633857|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633858|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633859|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If 2 or more DLTs were observed for a dose level combination, the MTD was defined as the previous dose level combination.
633860|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633861|NCT00439270|E5|Reported Event|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633862|NCT00439270|E4|Reported Event|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633863|NCT00439270|E3|Reported Event|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
633864|NCT00439270|E2|Reported Event|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633865|NCT00439270|E1|Reported Event|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
633866|NCT00439244|B4|Baseline|Total|Total of all reporting groups
633867|NCT00439244|B3|Baseline|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633868|NCT00439244|B2|Baseline|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
633869|NCT00439244|B1|Baseline|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633870|NCT00439244|P3|Participant Flow|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633871|NCT00439244|P2|Participant Flow|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
633872|NCT00439244|P1|Participant Flow|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633873|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633874|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
634125|NCT00438464|O2|Outcome|GG4, Within Finasteride Arm|Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
633875|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633876|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633877|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
633878|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633879|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633880|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
633881|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633882|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633883|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
633884|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633885|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633886|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
633887|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633888|NCT00439244|E3|Reported Event|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633889|NCT00439244|E2|Reported Event|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
633890|NCT00439244|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
633891|NCT00439231|B1|Baseline|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
634126|NCT00438464|O1|Outcome|GG3, Within Finasteride Arm|Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
633892|NCT00439231|P1|Participant Flow|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with CLL/SLL using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
633893|NCT00439231|O1|Outcome|CLL Subject Response Rate After Lenalidomide Therapy|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) using a 3 week on, 3 week off dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
633894|NCT00439231|E1|Reported Event|CLL Subjects Treated With Lenalidomide (Revlimid)|
633895|NCT00439218|B1|Baseline|Subject Enrollments (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633896|NCT00439218|P1|Participant Flow|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633897|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633898|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633899|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633900|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633901|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633902|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633903|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633947|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633948|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633949|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633904|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633905|NCT00439218|E1|Reported Event|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
633906|NCT00439179|B5|Baseline|Total|Total of all reporting groups
633907|NCT00439179|B4|Baseline|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
633908|NCT00439179|B3|Baseline|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
633909|NCT00439179|B2|Baseline|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
633910|NCT00439179|B1|Baseline|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
633911|NCT00439179|P4|Participant Flow|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)
633912|NCT00439179|P3|Participant Flow|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)
633913|NCT00439179|P2|Participant Flow|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)
633914|NCT00439179|P1|Participant Flow|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)
633915|NCT00439179|O4|Outcome|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
633916|NCT00439179|O3|Outcome|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
633917|NCT00439179|O2|Outcome|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
633918|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
633919|NCT00439179|O4|Outcome|Cohort 4|GEMOX+ GW572016 1500mg/day
633920|NCT00439179|O3|Outcome|Cohort 3|GEMOX+ GW572016 1000mg day
633921|NCT00439179|O2|Outcome|Cohort 2|weekly gem+ GW572016, 1500mg/day
633922|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
633923|NCT00439179|E4|Reported Event|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
633924|NCT00439179|E3|Reported Event|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
633925|NCT00439179|E2|Reported Event|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
633926|NCT00439179|E1|Reported Event|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
633927|NCT00439140|B4|Baseline|Total|Total of all reporting groups
633928|NCT00439140|B3|Baseline|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
633929|NCT00439140|B2|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633930|NCT00439140|B1|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633931|NCT00439140|P3|Participant Flow|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1. (If applicable after 12 weeks, participants received either botulinum toxin Type A 200U or 300U in Treatment Cycle 2.)
633932|NCT00439140|P2|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633933|NCT00439140|P1|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633934|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633935|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633936|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633937|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633938|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633939|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633940|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633941|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633942|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633943|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633944|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633945|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
649770|NCT00402987|O4|Outcome|Placebo|
633950|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633951|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633952|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633953|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633954|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633955|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
633956|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633957|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633958|NCT00439140|E3|Reported Event|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
633959|NCT00439140|E2|Reported Event|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
633960|NCT00439140|E1|Reported Event|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
633961|NCT00438971|B1|Baseline|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633962|NCT00438971|P1|Participant Flow|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633963|NCT00438971|O1|Outcome|Duloxetine|
633964|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633965|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633966|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633967|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633968|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633969|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633970|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633971|NCT00438971|E1|Reported Event|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
633972|NCT00438932|B5|Baseline|Total|Total of all reporting groups
633973|NCT00438932|B4|Baseline|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633974|NCT00438932|B3|Baseline|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
633975|NCT00438932|B2|Baseline|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633976|NCT00438932|B1|Baseline|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
633977|NCT00438932|P4|Participant Flow|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633978|NCT00438932|P3|Participant Flow|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
649771|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
633979|NCT00438932|P2|Participant Flow|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633980|NCT00438932|P1|Participant Flow|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
633981|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633982|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
633983|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633984|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
633985|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633986|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
633987|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633988|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
633989|NCT00438932|E4|Reported Event|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633990|NCT00438932|E3|Reported Event|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
633991|NCT00438932|E2|Reported Event|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
633992|NCT00438932|E1|Reported Event|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
633993|NCT00438880|B3|Baseline|Total|Total of all reporting groups
633994|NCT00438880|B2|Baseline|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
633995|NCT00438880|B1|Baseline|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
633996|NCT00438880|P2|Participant Flow|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
633997|NCT00438880|P1|Participant Flow|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
633998|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
633999|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634000|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634001|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634002|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634073|NCT00438672|E1|Reported Event|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
634003|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634004|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634005|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634006|NCT00438880|E2|Reported Event|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634007|NCT00438880|E1|Reported Event|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
634008|NCT00438854|B1|Baseline|Dasatinib Treatment|"All patients were treated with Dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
634009|NCT00438854|P1|Participant Flow|Dasatinib Treatment|"All patients were treated with Dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
634010|NCT00438854|O1|Outcome|Dasatinib Treatment|"All patients were treated with dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
634011|NCT00438854|O1|Outcome|Dasatinib Treatment|"All patients were treated with dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
634012|NCT00438854|O1|Outcome|Dasatinib Treatment|"All patients were treated with dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
634013|NCT00438854|O1|Outcome|Dasatinib Treatment|"All patients were treated with dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
634014|NCT00438854|E1|Reported Event|Dasatinib Treatment|"All patients were treated with dasatinib pills by mouth as treatment.~Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects."
634015|NCT00438815|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634016|NCT00438815|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634017|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634018|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634019|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634020|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634021|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634022|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634023|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634024|NCT00438815|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
634025|NCT00438802|B4|Baseline|Total|Total of all reporting groups
634026|NCT00438802|B3|Baseline|Dose Level 3|"Dose Level 3= 0.30 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634027|NCT00438802|B2|Baseline|Dose Level 2|"Dose Level 2= 0.20 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634028|NCT00438802|B1|Baseline|Dose Level 1|"Starting Dose Level 1= 0.15 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634074|NCT00438659|B3|Baseline|Total|Total of all reporting groups
634029|NCT00438802|P3|Participant Flow|Dose Level 3|"Starting Dose Level 1= 0.30 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634030|NCT00438802|P2|Participant Flow|Dose Level 2|"Starting Dose Level 1= 0.20 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634031|NCT00438802|P1|Participant Flow|Dose Level 1|"Starting Dose Level 1= 0.15 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634032|NCT00438802|O1|Outcome|All Patients|"Dose Level 1= 0.15 mg/kg > Dose Level 2= 0.20 mg/kg > Dose Level 3= 0.30 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634033|NCT00438802|O3|Outcome|Dose Level 3|"Dose Level 3= 0.30 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634034|NCT00438802|O2|Outcome|Dose Level 2|"Dose Level 2= 0.20 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634035|NCT00438802|O1|Outcome|Dose Level 1|"Starting Dose Level 1= 0.15 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634036|NCT00438802|O3|Outcome|Dose Level 3|"Dose Level 3= 0.30 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634037|NCT00438802|O2|Outcome|Dose Level 2|"Dose Level 2= 0.20 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634038|NCT00438802|O1|Outcome|Dose Level 1|"Dose Level 1= 0.15 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >~> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks"
634039|NCT00438802|E3|Reported Event|Dose Level 3|Alefacept by IV 1 x every 4 weeks
634040|NCT00438802|E2|Reported Event|Dose Level 2|Alefacept by IV 1 x every 4 weeks
634041|NCT00438802|E1|Reported Event|Dose Level 1|Alefacept by IV 1 x every 4 weeks
634042|NCT00438750|B3|Baseline|Total|Total of all reporting groups
634043|NCT00438750|B2|Baseline|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634044|NCT00438750|B1|Baseline|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634045|NCT00438750|P2|Participant Flow|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634046|NCT00438750|P1|Participant Flow|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634047|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634048|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634049|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634050|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634051|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634052|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634053|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634054|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634055|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634056|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634057|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634058|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634059|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634060|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634061|NCT00438750|E2|Reported Event|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
634062|NCT00438750|E1|Reported Event|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
634063|NCT00438672|B3|Baseline|Total|Total of all reporting groups
634064|NCT00438672|B2|Baseline|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
634065|NCT00438672|B1|Baseline|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
634066|NCT00438672|P2|Participant Flow|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
634067|NCT00438672|P1|Participant Flow|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
634068|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
634069|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
634070|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
634071|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
634072|NCT00438672|E2|Reported Event|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
634076|NCT00438659|B1|Baseline|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634077|NCT00438659|P2|Participant Flow|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
634078|NCT00438659|P1|Participant Flow|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634079|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
634080|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634081|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
634082|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634083|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
634084|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634085|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
634086|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634087|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
634088|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634089|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
634090|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634091|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
634092|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634093|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
634094|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634095|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
634096|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634097|NCT00438659|E2|Reported Event|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
634098|NCT00438659|E1|Reported Event|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
634099|NCT00438490|B3|Baseline|Total|Total of all reporting groups
634100|NCT00438490|B2|Baseline|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
634101|NCT00438490|B1|Baseline|Placebo|
634102|NCT00438490|P2|Participant Flow|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
634103|NCT00438490|P1|Participant Flow|Placebo|Normal Saline Placebo once daily
634104|NCT00438490|O2|Outcome|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
634105|NCT00438490|O1|Outcome|Placebo|Normal Saline Placebo once daily
634106|NCT00438490|O2|Outcome|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
634107|NCT00438490|O1|Outcome|Placebo|Normal Saline Placebo once daily
634108|NCT00438490|O2|Outcome|Placebo|"Normal saline placebo subcutaneous injection~Recombinant Human Prolactin"
634109|NCT00438490|O1|Outcome|Recombinant Human Prolactin|"Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection~Recombinant Human Prolactin"
634110|NCT00438490|O2|Outcome|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
634111|NCT00438490|O1|Outcome|Placebo|
634112|NCT00438490|E2|Reported Event|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
634113|NCT00438490|E1|Reported Event|Placebo|Placebo
634114|NCT00438464|B3|Baseline|Total|Total of all reporting groups
634115|NCT00438464|B2|Baseline|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634116|NCT00438464|B1|Baseline|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634117|NCT00438464|P2|Participant Flow|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634118|NCT00438464|P1|Participant Flow|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634119|NCT00438464|O2|Outcome|Within GG4, Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
634120|NCT00438464|O1|Outcome|Within GG3, Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
634121|NCT00438464|O2|Outcome|Within GG4, Finasteride Arm|Participants with GG4 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
634122|NCT00438464|O1|Outcome|Within GG3, Finasteride Arm|Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
634123|NCT00438464|O2|Outcome|GG4, Within Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
634124|NCT00438464|O1|Outcome|GG3, Within Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
634127|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634128|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634129|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634130|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634131|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634132|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634133|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634134|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634135|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634136|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634137|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634138|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634139|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634140|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634141|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634142|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634143|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634144|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634145|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634146|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634147|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634148|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634149|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634150|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634151|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634152|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634153|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634154|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634155|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634156|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634157|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634158|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634159|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634160|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634161|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634162|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634163|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634164|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634165|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634166|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634167|NCT00438464|E2|Reported Event|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
634168|NCT00438464|E1|Reported Event|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
634169|NCT00438451|B4|Baseline|Total|Total of all reporting groups
634170|NCT00438451|B3|Baseline|Lamotrigine|Lamotrigine 25mg
634171|NCT00438451|B2|Baseline|Carbamazepine|Carbamazepine 100mg
634172|NCT00438451|B1|Baseline|Levetiracetam|Levetiracetam 250mg
634173|NCT00438451|P3|Participant Flow|Lamotrigine|Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
634174|NCT00438451|P2|Participant Flow|Carbamazepine|"Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
634238|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
635281|NCT00435942|E1|Reported Event|Relay Device Group|Endovascular Treatment arm
634175|NCT00438451|P1|Participant Flow|Levetiracetam|"Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
634176|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634177|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634178|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634179|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634180|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634181|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634182|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634183|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634184|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634185|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634186|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634187|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634188|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634189|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634190|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634191|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634192|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634193|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634194|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634195|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634196|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634197|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634198|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634199|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634200|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634201|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634202|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634203|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634204|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634205|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634206|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634207|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634208|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634209|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
634210|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
634211|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
634212|NCT00438451|E3|Reported Event|Lamotrigine|Lamotrigine 25mg
634213|NCT00438451|E2|Reported Event|Carbamazepine|Carbamazepine 100mg
634214|NCT00438451|E1|Reported Event|Levetiracetam|Levetiracetam 250mg
634215|NCT00438399|B4|Baseline|Total|Total of all reporting groups
634216|NCT00438399|B3|Baseline|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
634217|NCT00438399|B2|Baseline|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
634218|NCT00438399|B1|Baseline|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
634219|NCT00438399|P6|Participant Flow|Corticosteroid 3-Wash Out-C. Propionate|Corticosteroid 3 first, then Clobetasol propionate
634220|NCT00438399|P5|Participant Flow|C. Propionate -Wash Out-Corticosteroid 3|Clobetasol propionate shampoo first then Corticosteroid 3
634221|NCT00438399|P4|Participant Flow|Corticosteroid 2-Wash Out-C. Propionate|Corticosteroid 2 first, then Clobetasol propionate shampoo
634222|NCT00438399|P3|Participant Flow|C. Propionate-Wash Out-Corticosteroid 2|Clobetasol propionate Shampoo first, then Corticosteroid 2
634223|NCT00438399|P2|Participant Flow|Corticosteroid 1-Wash Out-C. Propionate|Corticosteroid 1 first then Clobetasol propionate Shampoo
634224|NCT00438399|P1|Participant Flow|C. Propionate-Wash Out-Corticosteroid 1|Clobetasol propionate Shampoo first, then Corticosteroid 1
634225|NCT00438399|O3|Outcome|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
634226|NCT00438399|O2|Outcome|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
634227|NCT00438399|O1|Outcome|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
634228|NCT00438399|E4|Reported Event|Clobetasol Propionate Shampoo|All subjects having used Clobetasol propionate shampoo
634229|NCT00438399|E3|Reported Event|Corticosteroid 3|All subjects having used Corticosteroid 3
634230|NCT00438399|E2|Reported Event|Corticosteroid 2|All subjects having used Corticosteroid 2
634231|NCT00438399|E1|Reported Event|Corticosteroid 1|All subjects having used Corticosteroid 1
634232|NCT00438360|B3|Baseline|Total|Total of all reporting groups
634233|NCT00438360|B2|Baseline|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
634234|NCT00438360|B1|Baseline|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
634235|NCT00438360|P2|Participant Flow|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
634236|NCT00438360|P1|Participant Flow|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
634237|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
635282|NCT00435929|B3|Baseline|Total|Total of all reporting groups
634239|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
634240|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
634241|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
634242|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
634243|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
634244|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
634245|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
634246|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
634247|NCT00438360|E2|Reported Event|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
634248|NCT00438360|E1|Reported Event|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
634249|NCT00438204|B1|Baseline|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
634250|NCT00438204|P1|Participant Flow|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
634251|NCT00438204|O1|Outcome|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
634252|NCT00438204|E1|Reported Event|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
634253|NCT00438191|B3|Baseline|Total|Total of all reporting groups
634254|NCT00438191|B2|Baseline|Full Time Splinting|Subjects who wear the splint as much as possible
634255|NCT00438191|B1|Baseline|As-Desired Splinting|Subjects who wear the splint as desired
634256|NCT00438191|P2|Participant Flow|Full Time Splinting|Subjects who wear the splint as much as possible
634257|NCT00438191|P1|Participant Flow|As-Desired Splinting|Subjects who wear the splint as desired
634258|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
634259|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
634260|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
634261|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
634262|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
634263|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
634264|NCT00438191|O2|Outcome|Full Time Splinting|Subjects who wear the splint as much as possible
634265|NCT00438191|O1|Outcome|As-Desired Splinting|Subjects who wear the splint as desired
634266|NCT00438191|E2|Reported Event|Full Time Splinting|Subjects who wear the splint as much as possible
634267|NCT00438191|E1|Reported Event|As-Desired Splinting|Subjects who wear the splint as desired
634268|NCT00438100|B3|Baseline|Total|Total of all reporting groups
634269|NCT00438100|B2|Baseline|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
634270|NCT00438100|B1|Baseline|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
634271|NCT00438100|P2|Participant Flow|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
634272|NCT00438100|P1|Participant Flow|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
634273|NCT00438100|O2|Outcome|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
634274|NCT00438100|O1|Outcome|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
634275|NCT00438100|E2|Reported Event|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
634276|NCT00438100|E1|Reported Event|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
634277|NCT00437983|B3|Baseline|Total|Total of all reporting groups
634278|NCT00437983|B2|Baseline|Placebo|Cellulose tainted with fishy odor
634279|NCT00437983|B1|Baseline|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
634280|NCT00437983|P2|Participant Flow|Placebo|Cellulose tainted with fishy odor
634281|NCT00437983|P1|Participant Flow|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
634282|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
634283|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
634284|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
634285|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
634286|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
634287|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
634288|NCT00437983|E2|Reported Event|Placebo|Cellulose tainted with fishy odor
634289|NCT00437983|E1|Reported Event|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
634290|NCT00437645|B3|Baseline|Total|Total of all reporting groups
634291|NCT00437645|B2|Baseline|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634292|NCT00437645|B1|Baseline|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634293|NCT00437645|P2|Participant Flow|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634294|NCT00437645|P1|Participant Flow|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634295|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634296|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634297|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634298|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634320|NCT00437489|E2|Reported Event|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
649772|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
634299|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634300|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634301|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634302|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634303|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634304|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634305|NCT00437645|E2|Reported Event|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634306|NCT00437645|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
634307|NCT00437489|B3|Baseline|Total|Total of all reporting groups
634308|NCT00437489|B2|Baseline|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
634309|NCT00437489|B1|Baseline|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
634310|NCT00437489|P2|Participant Flow|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
634311|NCT00437489|P1|Participant Flow|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
634312|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
634313|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
634314|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
634315|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
634316|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
634317|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
634318|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
634319|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
634321|NCT00437489|E1|Reported Event|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
634322|NCT00437398|B1|Baseline|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
634323|NCT00437398|P1|Participant Flow|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
634324|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
634325|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
634326|NCT00437398|E1|Reported Event|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
634327|NCT00437281|B21|Baseline|Total|Total of all reporting groups
634328|NCT00437281|B20|Baseline|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634329|NCT00437281|B19|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634330|NCT00437281|B18|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634331|NCT00437281|B17|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634332|NCT00437281|B16|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634333|NCT00437281|B15|Baseline|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634334|NCT00437281|B14|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634335|NCT00437281|B13|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634336|NCT00437281|B12|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634337|NCT00437281|B11|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634338|NCT00437281|B10|Baseline|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634339|NCT00437281|B9|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634340|NCT00437281|B8|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634833|NCT00437034|B1|Baseline|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
634341|NCT00437281|B7|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634342|NCT00437281|B6|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634343|NCT00437281|B5|Baseline|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634344|NCT00437281|B4|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634345|NCT00437281|B3|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634346|NCT00437281|B2|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634347|NCT00437281|B1|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634348|NCT00437281|P20|Participant Flow|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634349|NCT00437281|P19|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634350|NCT00437281|P18|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634351|NCT00437281|P17|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634352|NCT00437281|P16|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634353|NCT00437281|P15|Participant Flow|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634354|NCT00437281|P14|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634355|NCT00437281|P13|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634356|NCT00437281|P12|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
635588|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
634357|NCT00437281|P11|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634358|NCT00437281|P10|Participant Flow|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634359|NCT00437281|P9|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634360|NCT00437281|P8|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634361|NCT00437281|P7|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634362|NCT00437281|P6|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634363|NCT00437281|P5|Participant Flow|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634364|NCT00437281|P4|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634365|NCT00437281|P3|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634366|NCT00437281|P2|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634367|NCT00437281|P1|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634368|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634369|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634370|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634371|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634372|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
637419|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
634373|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634374|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634375|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634376|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634377|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634378|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634379|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634380|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634381|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634382|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634383|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634384|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634385|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634386|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634387|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634388|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634875|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
637420|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
634389|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634390|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634391|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634392|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634393|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634394|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634395|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634396|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634397|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634398|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634399|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634400|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634401|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634402|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634403|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634404|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634405|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634406|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634407|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634408|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634409|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634410|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634411|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634412|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634413|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634414|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634415|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634416|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634417|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634418|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634419|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634420|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634421|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634688|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634422|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634423|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634424|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634425|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634426|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634427|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634428|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634429|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634430|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634431|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634432|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634433|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634434|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634435|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634436|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634437|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634438|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634439|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634440|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634441|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634442|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634443|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634444|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634445|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634446|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634447|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634448|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634449|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634450|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634451|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634452|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634453|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634454|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634708|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634455|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634456|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634457|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634458|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634459|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634460|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634461|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634462|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634463|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634464|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634465|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634466|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634467|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634468|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634469|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634470|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634471|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634472|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634473|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634474|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634475|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634476|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634477|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634478|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634479|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634480|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634481|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634482|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634483|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634484|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634485|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634486|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634487|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634728|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634488|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634489|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634490|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634491|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634492|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634493|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634494|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634495|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634496|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634497|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634498|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634499|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634500|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634501|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634502|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634503|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634504|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634505|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634506|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634507|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634508|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634509|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634510|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634511|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634512|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634513|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634514|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634515|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634516|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634517|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634518|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634519|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634520|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634748|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634521|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634522|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634523|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634524|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634525|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634526|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634527|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634528|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634529|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634530|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634531|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634532|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634533|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634534|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634535|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634536|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634537|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634538|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634539|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634540|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634541|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634542|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634543|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634544|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634545|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634546|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634547|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634548|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634549|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634550|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634551|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634552|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634553|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634768|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634554|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634555|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634556|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634557|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634558|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634559|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634560|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634561|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634562|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634563|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634564|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634565|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634566|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634567|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634568|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634569|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634570|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634571|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634572|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634573|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634574|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634575|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634576|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634577|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634578|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634579|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634580|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634581|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634582|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634583|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634584|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634585|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634586|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634792|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634587|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634588|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634589|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634590|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634591|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634592|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634593|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634594|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634595|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634596|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634597|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634598|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634599|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634600|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634601|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634602|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634793|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634603|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634604|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634605|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634606|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634607|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634608|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634609|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634610|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634611|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634612|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634613|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634614|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634615|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634616|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634617|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634618|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634794|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634619|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634620|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634621|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634622|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634623|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634624|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634625|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634626|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634627|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634628|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634629|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634630|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634631|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634632|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634633|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634634|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634795|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634635|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634636|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634637|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634638|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634639|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634640|NCT00437281|E20|Reported Event|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634641|NCT00437281|E19|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634642|NCT00437281|E18|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634643|NCT00437281|E17|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634644|NCT00437281|E16|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634645|NCT00437281|E15|Reported Event|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634646|NCT00437281|E14|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634647|NCT00437281|E13|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634648|NCT00437281|E12|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634649|NCT00437281|E11|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634650|NCT00437281|E10|Reported Event|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
635406|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
634651|NCT00437281|E9|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634652|NCT00437281|E8|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634653|NCT00437281|E7|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634654|NCT00437281|E6|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634655|NCT00437281|E5|Reported Event|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634656|NCT00437281|E4|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634657|NCT00437281|E3|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634658|NCT00437281|E2|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634659|NCT00437281|E1|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
634660|NCT00437203|B11|Baseline|Total|Total of all reporting groups
634661|NCT00437203|B10|Baseline|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634662|NCT00437203|B9|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634663|NCT00437203|B8|Baseline|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634664|NCT00437203|B7|Baseline|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634665|NCT00437203|B6|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634666|NCT00437203|B5|Baseline|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634667|NCT00437203|B4|Baseline|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634668|NCT00437203|B3|Baseline|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634796|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634797|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634669|NCT00437203|B2|Baseline|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634670|NCT00437203|B1|Baseline|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634671|NCT00437203|P10|Participant Flow|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634672|NCT00437203|P9|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634673|NCT00437203|P8|Participant Flow|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634674|NCT00437203|P7|Participant Flow|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634675|NCT00437203|P6|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634676|NCT00437203|P5|Participant Flow|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634677|NCT00437203|P4|Participant Flow|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634678|NCT00437203|P3|Participant Flow|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634679|NCT00437203|P2|Participant Flow|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634680|NCT00437203|P1|Participant Flow|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 milligram (mg) 3 hours (hrs) infusion intravenously (IV) on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg per square meter (mg/m^2) 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634681|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634682|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634683|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634684|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634685|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634686|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634687|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
649773|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
634689|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634690|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634691|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634692|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634693|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634694|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634695|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634696|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634697|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634698|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634699|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634700|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634701|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634702|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634703|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634704|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634705|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634706|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634707|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634798|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634709|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634710|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634711|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634712|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634713|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634714|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634715|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634716|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634717|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634718|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634719|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634720|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634721|NCT00437203|O7|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634722|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634723|NCT00437203|O5|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634724|NCT00437203|O4|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634725|NCT00437203|O3|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634726|NCT00437203|O2|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634727|NCT00437203|O1|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634799|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634729|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634730|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634731|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634732|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634733|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634734|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634735|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634736|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634737|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634738|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634739|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634740|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634741|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634742|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634743|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634744|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634745|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634746|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634747|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634800|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634749|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634750|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634751|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634752|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634753|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634754|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634755|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634756|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634757|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634758|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634759|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634760|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634761|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634762|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634763|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634764|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634765|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634766|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634767|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634801|NCT00437125|E1|Reported Event|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634769|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634770|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634771|NCT00437203|O2|Outcome|PF-00477736 + Gemcitabine 1000 mg/m^2|PF-00477736 infusion 180 mg or 225 mg IV administered over 24 hrs on Days 2 and 9 of each cycle (21 days cycle) along with gemcitabine infusion 1000 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634772|NCT00437203|O1|Outcome|PF-00477736 + Gemcitabine 750 mg/m^2|PF-00477736 infusion 50 mg, 65 mg or 80 mg IV administered over 3 hrs on Days 1 and 8 of Cycle 0 (21 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle), or PF-00477736 infusion 80 mg, 120 mg, 180 mg, 270 mg or 340 mg IV administered over 24 hrs on Days 1 and 8 of Cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 750 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634773|NCT00437203|E10|Reported Event|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634774|NCT00437203|E9|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
634775|NCT00437203|E8|Reported Event|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634776|NCT00437203|E7|Reported Event|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634777|NCT00437203|E6|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634778|NCT00437203|E5|Reported Event|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634779|NCT00437203|E4|Reported Event|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634780|NCT00437203|E3|Reported Event|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634781|NCT00437203|E2|Reported Event|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634782|NCT00437203|E1|Reported Event|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
634783|NCT00437125|B1|Baseline|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634784|NCT00437125|P1|Participant Flow|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634785|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634786|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634787|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634788|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634789|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634790|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634791|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
634803|NCT00437073|B2|Baseline|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634804|NCT00437073|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634805|NCT00437073|P2|Participant Flow|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634806|NCT00437073|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634807|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634808|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634809|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634810|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634811|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634812|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634813|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634814|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634815|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634816|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634817|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
635407|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
634818|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634819|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634820|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634821|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634822|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634823|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634824|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634825|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634826|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634827|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634828|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634829|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634830|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634831|NCT00437073|E2|Reported Event|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
634832|NCT00437073|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
634834|NCT00437034|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
634835|NCT00437034|O1|Outcome|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
634836|NCT00437034|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
634837|NCT00436982|B3|Baseline|Total|Total of all reporting groups
634838|NCT00436982|B2|Baseline|Duracon|30 patients randomized into the Duracon arm
634839|NCT00436982|B1|Baseline|Triathlon|30 patients randomized into the Triathlon arm
634840|NCT00436982|P2|Participant Flow|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
634841|NCT00436982|P1|Participant Flow|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Cemented Triathlon total knee system: Orthopaedic implant"
634842|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
634843|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
634844|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
634845|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
634846|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
634847|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
634848|NCT00436982|O2|Outcome|Triathlon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Triathlon total knee system: Orthopaedic implant"
634849|NCT00436982|O1|Outcome|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
634850|NCT00436982|O2|Outcome|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
634851|NCT00436982|O1|Outcome|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Cemented Triathlon total knee system: Orthopaedic implant"
634852|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
634853|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
634854|NCT00436982|O2|Outcome|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
634855|NCT00436982|O1|Outcome|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Cemented Triathlon total knee system: Orthopaedic implant"
634856|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
634857|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
634858|NCT00436982|E2|Reported Event|Duracon|30 patients randomized into the Duracon arm
634859|NCT00436982|E1|Reported Event|Triathlon|30 patients randomized into the Triathlon arm
634860|NCT00436969|B3|Baseline|Total|Total of all reporting groups
634861|NCT00436969|B2|Baseline|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634862|NCT00436969|B1|Baseline|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634863|NCT00436969|P2|Participant Flow|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634864|NCT00436969|P1|Participant Flow|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634865|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634866|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634867|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634868|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634869|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634870|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634871|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634872|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634873|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634874|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634876|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634877|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634878|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634879|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634880|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634881|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634882|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634883|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634884|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634885|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634886|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634887|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634888|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634889|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634890|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634891|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634892|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634893|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634894|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634895|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634896|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634897|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634898|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634899|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634900|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634901|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634902|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634903|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634904|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634905|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634906|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634907|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634908|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
634909|NCT00436969|E2|Reported Event|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
634910|NCT00436969|E1|Reported Event|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).
634911|NCT00436956|B1|Baseline|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
634912|NCT00436956|P2|Participant Flow|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
634913|NCT00436956|P1|Participant Flow|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
634914|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
634915|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
634916|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
634917|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
634918|NCT00436956|O1|Outcome|All Participants- AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
635408|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
634919|NCT00436956|O1|Outcome|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
634920|NCT00436956|E1|Reported Event|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
634921|NCT00436917|B1|Baseline|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
634922|NCT00436917|P1|Participant Flow|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
634923|NCT00436917|O1|Outcome|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
634924|NCT00436917|E1|Reported Event|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
634925|NCT00436904|B1|Baseline|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634926|NCT00436904|P1|Participant Flow|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634927|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634928|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634929|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634930|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634931|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634932|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634933|NCT00436904|E1|Reported Event|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
634934|NCT00436852|B3|Baseline|Total|Total of all reporting groups
634935|NCT00436852|B2|Baseline|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
634936|NCT00436852|B1|Baseline|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
634937|NCT00436852|P2|Participant Flow|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
634938|NCT00436852|P1|Participant Flow|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
634939|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
634940|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
634941|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
634942|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
634943|NCT00436852|E2|Reported Event|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
634944|NCT00436852|E1|Reported Event|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
634945|NCT00436826|B3|Baseline|Total|Total of all reporting groups
634946|NCT00436826|B2|Baseline|Placebo, IFN-beta|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
635027|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
649774|NCT00402987|O3|Outcome|Placebo|
634947|NCT00436826|B1|Baseline|Cladribine 3.5 mg/kg, IFN-beta|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
634948|NCT00436826|P6|Participant Flow|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634949|NCT00436826|P5|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634950|NCT00436826|P4|Participant Flow|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634951|NCT00436826|P3|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634952|NCT00436826|P2|Participant Flow|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634953|NCT00436826|P1|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks.
634954|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634955|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634956|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634957|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634958|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634959|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634960|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
635028|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
634961|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634962|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634963|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634964|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634965|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634966|NCT00436826|E6|Reported Event|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634967|NCT00436826|E5|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634968|NCT00436826|E4|Reported Event|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634969|NCT00436826|E3|Reported Event|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
634970|NCT00436826|E2|Reported Event|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634971|NCT00436826|E1|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
634972|NCT00436748|B3|Baseline|Total|Total of all reporting groups
634973|NCT00436748|B2|Baseline|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634974|NCT00436748|B1|Baseline|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634975|NCT00436748|P2|Participant Flow|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634976|NCT00436748|P1|Participant Flow|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
649775|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
634977|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634978|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634979|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634980|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634981|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634982|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634983|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634984|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634985|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634986|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634987|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634988|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634989|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634990|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635080|NCT00436501|O2|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
649776|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
634991|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634992|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634993|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634994|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634995|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634996|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634997|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634998|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
634999|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635000|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635001|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635002|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635003|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635004|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635171|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
637421|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
635005|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635006|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635007|NCT00436748|E2|Reported Event|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635008|NCT00436748|E1|Reported Event|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
635009|NCT00436644|B1|Baseline|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
635010|NCT00436644|P1|Participant Flow|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
635011|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
635012|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
635013|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
635014|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
635015|NCT00436644|E1|Reported Event|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
635016|NCT00436618|B4|Baseline|Total|Total of all reporting groups
635017|NCT00436618|B3|Baseline|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635018|NCT00436618|B2|Baseline|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635019|NCT00436618|B1|Baseline|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635020|NCT00436618|P3|Participant Flow|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635021|NCT00436618|P2|Participant Flow|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635022|NCT00436618|P1|Participant Flow|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635023|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635024|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635025|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635026|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
649777|NCT00402987|O4|Outcome|Placebo|
635029|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635030|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635031|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635032|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635033|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635034|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635035|NCT00436618|E3|Reported Event|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635036|NCT00436618|E2|Reported Event|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635037|NCT00436618|E1|Reported Event|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
635038|NCT00436605|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
635039|NCT00436605|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
635040|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
635041|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
635042|NCT00436605|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
635043|NCT00436566|B1|Baseline|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
635044|NCT00436566|P1|Participant Flow|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
635045|NCT00436566|O1|Outcome|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
635046|NCT00436566|E1|Reported Event|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
635047|NCT00436553|B4|Baseline|Total|Total of all reporting groups
635048|NCT00436553|B3|Baseline|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
635081|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
635049|NCT00436553|B2|Baseline|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635050|NCT00436553|B1|Baseline|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635051|NCT00436553|P3|Participant Flow|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
635052|NCT00436553|P2|Participant Flow|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635053|NCT00436553|P1|Participant Flow|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635054|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635055|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635056|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
635168|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
635057|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635058|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635059|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
635060|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635061|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635062|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
635063|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635064|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635169|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
649778|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
635065|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
635066|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635067|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635068|NCT00436553|E3|Reported Event|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
635069|NCT00436553|E2|Reported Event|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635070|NCT00436553|E1|Reported Event|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
635071|NCT00436501|B3|Baseline|Total|Total of all reporting groups
635072|NCT00436501|B2|Baseline|Phase II VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
635073|NCT00436501|B1|Baseline|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
635074|NCT00436501|P2|Participant Flow|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
635075|NCT00436501|P1|Participant Flow|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
635076|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
635077|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
635078|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
635079|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
649779|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
635082|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
635083|NCT00436501|E2|Reported Event|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
635084|NCT00436501|E1|Reported Event|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
635085|NCT00436436|B1|Baseline|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635086|NCT00436436|P1|Participant Flow|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635087|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635088|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635089|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635090|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635091|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635092|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635093|NCT00436436|E1|Reported Event|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
635094|NCT00436345|B3|Baseline|Total|Total of all reporting groups
635095|NCT00436345|B2|Baseline|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635096|NCT00436345|B1|Baseline|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635097|NCT00436345|P2|Participant Flow|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635098|NCT00436345|P1|Participant Flow|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635099|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635100|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635101|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635102|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635103|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635104|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635105|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635106|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635107|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per killograms per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635108|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635109|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635110|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635111|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635112|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635113|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635114|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635115|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635116|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635117|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635118|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635119|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635120|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635121|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635170|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
649780|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
635122|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635123|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635124|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635125|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635126|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635127|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635128|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635129|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635130|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635131|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635132|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635133|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635134|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635135|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635136|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635137|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635138|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635139|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635140|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635141|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635142|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635143|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635144|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635145|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635146|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635147|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635148|NCT00436345|E2|Reported Event|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
635149|NCT00436345|E1|Reported Event|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
635150|NCT00436332|B1|Baseline|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
635151|NCT00436332|P1|Participant Flow|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
635152|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
635153|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
635154|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
635155|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
635156|NCT00436332|E1|Reported Event|Erlotinib and Bevacizumab|Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
635157|NCT00436215|B1|Baseline|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
635158|NCT00436215|P1|Participant Flow|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
635159|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
635160|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
635161|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
635162|NCT00436215|E1|Reported Event|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
635163|NCT00436163|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
635164|NCT00436163|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.
635165|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
635166|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
635167|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
637422|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
635172|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
635173|NCT00436163|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
635174|NCT00436046|B4|Baseline|Total|Total of all reporting groups
635175|NCT00436046|B3|Baseline|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635176|NCT00436046|B2|Baseline|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635177|NCT00436046|B1|Baseline|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635178|NCT00436046|P3|Participant Flow|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635179|NCT00436046|P2|Participant Flow|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635180|NCT00436046|P1|Participant Flow|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635181|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635182|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635183|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635184|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635185|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635186|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635187|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635188|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635189|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635190|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635191|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635192|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635193|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635194|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635195|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635196|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635197|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635198|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635199|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635200|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635201|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635202|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635203|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635204|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635205|NCT00436046|E3|Reported Event|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
635206|NCT00436046|E2|Reported Event|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
635207|NCT00436046|E1|Reported Event|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
635208|NCT00436007|B4|Baseline|Total|Total of all reporting groups
635209|NCT00436007|B3|Baseline|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
637423|NCT00430781|O3|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
635210|NCT00436007|B2|Baseline|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635211|NCT00436007|B1|Baseline|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635212|NCT00436007|P3|Participant Flow|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635213|NCT00436007|P2|Participant Flow|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635214|NCT00436007|P1|Participant Flow|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635215|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635216|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635217|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635218|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635219|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635267|NCT00435994|O2|Outcome|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
637424|NCT00430781|O2|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
635220|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635221|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635222|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635223|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635224|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635225|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635226|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635227|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635228|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635229|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635268|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.
635269|NCT00435994|E3|Reported Event|Bronchiolitis|
635270|NCT00435994|E2|Reported Event|Respiratory Syncytial Virus|
635230|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635231|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635232|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635233|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635234|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635235|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635236|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635237|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635238|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635239|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635271|NCT00435994|E1|Reported Event|Healthy Control|
635272|NCT00435942|B3|Baseline|Total|Total of all reporting groups
635273|NCT00435942|B2|Baseline|Surgical Control Group|Open Surgical Repair arm
635274|NCT00435942|B1|Baseline|Relay Device Group|Endovascular Treatment arm
635240|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635241|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635242|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635243|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635244|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635245|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635246|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania
635247|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635248|NCT00436007|O1|Outcome|GSK 257049 1 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635249|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635275|NCT00435942|P2|Participant Flow|Surgical Control Group|Open Surgical Repair arm
635276|NCT00435942|P1|Participant Flow|Relay Device Group|Endovascular Treatment arm
635277|NCT00435942|O2|Outcome|Surgical Control Group|Open Surgical Repair arm
649781|NCT00402987|O3|Outcome|Placebo|
635250|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635251|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635252|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635253|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635254|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635255|NCT00436007|E3|Reported Event|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635256|NCT00436007|E2|Reported Event|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
635257|NCT00436007|E1|Reported Event|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
635258|NCT00435994|B4|Baseline|Total|Total of all reporting groups
635259|NCT00435994|B3|Baseline|Bronchiolitis|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
635260|NCT00435994|B2|Baseline|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
635261|NCT00435994|B1|Baseline|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
635262|NCT00435994|P3|Participant Flow|Bronchiolitis-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
635263|NCT00435994|P2|Participant Flow|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
635264|NCT00435994|P1|Participant Flow|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
635265|NCT00435994|O2|Outcome|Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis and respiratory syncytial virus received nasal wash only.
635266|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
635278|NCT00435942|O1|Outcome|Relay Device Group|Endovascular Treatment arm
635283|NCT00435929|B2|Baseline|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635284|NCT00435929|B1|Baseline|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635285|NCT00435929|P2|Participant Flow|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635286|NCT00435929|P1|Participant Flow|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635287|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635288|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635289|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635290|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635291|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635292|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635293|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635294|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635295|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635296|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635297|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635298|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635299|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635300|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635301|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635302|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635303|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635304|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635305|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635306|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635307|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635308|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635309|NCT00435929|E2|Reported Event|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
635310|NCT00435929|E1|Reported Event|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
635311|NCT00435825|B5|Baseline|Total|Total of all reporting groups
635312|NCT00435825|B4|Baseline|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635313|NCT00435825|B3|Baseline|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635314|NCT00435825|B2|Baseline|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635315|NCT00435825|B1|Baseline|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635316|NCT00435825|P4|Participant Flow|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635317|NCT00435825|P3|Participant Flow|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635318|NCT00435825|P2|Participant Flow|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635319|NCT00435825|P1|Participant Flow|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635320|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635321|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635322|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635323|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635324|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635325|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635326|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635327|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635328|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635329|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635330|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635331|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635332|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635333|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635334|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635335|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635336|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635337|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635338|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635339|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635340|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635341|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635342|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635343|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635344|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635345|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635346|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635347|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635348|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635349|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635350|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635351|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635352|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635353|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635354|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635355|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635356|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635357|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635358|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635359|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
638186|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
635360|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635361|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635362|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635363|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635364|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635365|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635366|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635367|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635368|NCT00435825|E4|Reported Event|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635369|NCT00435825|E3|Reported Event|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
635370|NCT00435825|E2|Reported Event|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635371|NCT00435825|E1|Reported Event|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
635372|NCT00435812|B3|Baseline|Total|Total of all reporting groups
635373|NCT00435812|B2|Baseline|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
635374|NCT00435812|B1|Baseline|HEPLISAV and/or Placebo|0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24
635375|NCT00435812|P2|Participant Flow|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
635376|NCT00435812|P1|Participant Flow|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0 and Week 4, plus a placebo (saline) injection at Week 24"
635377|NCT00435812|O2|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
635378|NCT00435812|O1|Outcome|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
635379|NCT00435812|O2|Outcome|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
635380|NCT00435812|O1|Outcome|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
635381|NCT00435812|E2|Reported Event|Engerix-B|"1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24"
635382|NCT00435812|E1|Reported Event|HEPLISAV and/or Placebo|"0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24"
635383|NCT00435591|B5|Baseline|Total|Total of all reporting groups
635384|NCT00435591|B4|Baseline|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
635385|NCT00435591|B3|Baseline|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
635386|NCT00435591|B2|Baseline|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
635387|NCT00435591|B1|Baseline|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
635388|NCT00435591|P4|Participant Flow|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
635389|NCT00435591|P3|Participant Flow|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
635390|NCT00435591|P2|Participant Flow|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
635391|NCT00435591|P1|Participant Flow|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
635392|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
635393|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
635394|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
635395|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
635396|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20mg)+20mg/day continuous infusion conivaptan per premix bag
635397|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
635398|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
635399|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
635400|NCT00435591|O1|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
635401|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
635402|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
635403|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
635404|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
635405|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
638187|NCT00428974|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
635409|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
635410|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
635411|NCT00435591|E4|Reported Event|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
635412|NCT00435591|E3|Reported Event|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
635413|NCT00435591|E2|Reported Event|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
635414|NCT00435591|E1|Reported Event|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
635415|NCT00435539|B6|Baseline|Total|Total of all reporting groups
635416|NCT00435539|B5|Baseline|Sham Injection|sham injection
635417|NCT00435539|B4|Baseline|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
635418|NCT00435539|B3|Baseline|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
635419|NCT00435539|B2|Baseline|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
635420|NCT00435539|B1|Baseline|Ocriplasmin 75µg Single Injection|ocriplasmin 75µg single injection versus sham injection
635421|NCT00435539|P5|Participant Flow|Sham Injection|sham injection
635422|NCT00435539|P4|Participant Flow|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
635423|NCT00435539|P3|Participant Flow|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
635424|NCT00435539|P2|Participant Flow|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
635425|NCT00435539|P1|Participant Flow|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
635426|NCT00435539|O4|Outcome|Sham Injection|sham injection
635427|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
635428|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
635429|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
635430|NCT00435539|O4|Outcome|Sham Injection|sham injection
635431|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
635432|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
635433|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
635434|NCT00435539|E5|Reported Event|Sham Injection|Sham injection
635435|NCT00435539|E4|Reported Event|Ocriplasmin 125µg Multiple Injection|Ocriplasmin 125µg multiple injection versus sham injection
635436|NCT00435539|E3|Reported Event|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
635437|NCT00435539|E2|Reported Event|Ocriplasmin 125µg Single Injection|Ocriplasmin 125µg single injection versus sham injection
635438|NCT00435539|E1|Reported Event|Ocriplasmin 75µg|Ocriplasmin 75µg single injection versus sham injection
635439|NCT00435487|B3|Baseline|Total|Total of all reporting groups
635440|NCT00435487|B2|Baseline|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635441|NCT00435487|B1|Baseline|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635442|NCT00435487|P2|Participant Flow|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635443|NCT00435487|P1|Participant Flow|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635444|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635445|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635446|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635474|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635447|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635448|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635449|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635450|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635451|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635452|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635453|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635454|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635455|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635456|NCT00435487|E2|Reported Event|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635457|NCT00435487|E1|Reported Event|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
635458|NCT00435461|B4|Baseline|Total|Total of all reporting groups
635459|NCT00435461|B3|Baseline|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635460|NCT00435461|B2|Baseline|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635461|NCT00435461|B1|Baseline|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635462|NCT00435461|P3|Participant Flow|Fex 180 Milligram (mg)|Participants received oral capsule (overencapsulated fexofenadine [Fex] 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635463|NCT00435461|P2|Participant Flow|FFNS 110 Microgram (mcg)|Participants received fluticasone furoate nasal spray (FFNS) 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635464|NCT00435461|P1|Participant Flow|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635465|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635466|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635467|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635468|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635469|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635470|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635471|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635472|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635473|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
649782|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
635475|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635476|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635477|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635478|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635479|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635480|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635481|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635482|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635483|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635484|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635485|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635486|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635487|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635488|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635489|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635490|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635491|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635492|NCT00435461|O3|Outcome|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635493|NCT00435461|O2|Outcome|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635494|NCT00435461|O1|Outcome|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635495|NCT00435461|E3|Reported Event|Fex 180 mg|Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
635496|NCT00435461|E2|Reported Event|FFNS 110 mcg|Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635497|NCT00435461|E1|Reported Event|Placebo|Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
635498|NCT00435409|B3|Baseline|Total|Total of all reporting groups
635499|NCT00435409|B2|Baseline|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635500|NCT00435409|B1|Baseline|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635501|NCT00435409|P3|Participant Flow|Capecitabine, Crossover to Sunitinib|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635502|NCT00435409|P2|Participant Flow|Capecitabine, no Crossover|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks.
635503|NCT00435409|P1|Participant Flow|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 milligrams (mg) once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 milligrams per square meter (mg/m^2) per day (1000 mg/m^2 twice daily [BID]) from Days 1-14 every 3 weeks.
635504|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635505|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635506|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635507|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635508|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635509|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635510|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635511|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635512|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635513|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635514|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635515|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635516|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635517|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635518|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635519|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635520|NCT00435409|E2|Reported Event|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
635521|NCT00435409|E1|Reported Event|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
635522|NCT00435370|B3|Baseline|Total|Total of all reporting groups
635523|NCT00435370|B2|Baseline|Placebo|Placebo + risperidone (6mg/day)
635524|NCT00435370|B1|Baseline|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
635525|NCT00435370|P2|Participant Flow|Placebo|Placebo + risperidone (6mg/day)
635526|NCT00435370|P1|Participant Flow|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
635527|NCT00435370|O2|Outcome|Placebo|Placebo + risperidone (6mg/day)
635528|NCT00435370|O1|Outcome|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
635529|NCT00435370|E2|Reported Event|Placebo|Placebo + risperidone (6mg/day)
635530|NCT00435370|E1|Reported Event|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
635531|NCT00435188|B3|Baseline|Total|Total of all reporting groups
635532|NCT00435188|B2|Baseline|Arm 2|Usual care
635533|NCT00435188|B1|Baseline|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic vis
635534|NCT00435188|P2|Participant Flow|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
635535|NCT00435188|P1|Participant Flow|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635536|NCT00435188|O2|Outcome|Arm 2|Usual care
635580|NCT00435162|P4|Participant Flow|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then placebo
635581|NCT00435162|P3|Participant Flow|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
635582|NCT00435162|P2|Participant Flow|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then placebo
635537|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635538|NCT00435188|O2|Outcome|Arm 2|Usual care
635539|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635540|NCT00435188|O2|Outcome|Arm 2|Usual care
635541|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635542|NCT00435188|O2|Outcome|Arm 2|Usual care
635543|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635544|NCT00435188|O2|Outcome|Arm 2|Usual care
635545|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635546|NCT00435188|O2|Outcome|Arm 2|Usual care
635547|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635548|NCT00435188|O2|Outcome|Arm 2|Usual care
635549|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635550|NCT00435188|O2|Outcome|Arm 2|Usual care
635551|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635552|NCT00435188|O2|Outcome|Arm 2|Usual care
635553|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635554|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
635555|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635556|NCT00435188|O2|Outcome|Arm 2|Usual care
635583|NCT00435162|P1|Participant Flow|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
635584|NCT00435162|O2|Outcome|Placebo|
635585|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
635586|NCT00435162|O2|Outcome|Placebo|
635557|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635558|NCT00435188|O2|Outcome|Arm 2|Usual care
635559|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635560|NCT00435188|O2|Outcome|Arm 2|Usual care
635561|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635562|NCT00435188|O2|Outcome|Arm 2|Usual care
635563|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635564|NCT00435188|O2|Outcome|Arm 2|Usual care
635565|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635566|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
635567|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635568|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
635569|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635570|NCT00435188|O2|Outcome|Arm 2|Usual care
635571|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635572|NCT00435188|E2|Reported Event|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
635573|NCT00435188|E1|Reported Event|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
635574|NCT00435162|B4|Baseline|Total|Total of all reporting groups
635575|NCT00435162|B3|Baseline|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
635576|NCT00435162|B2|Baseline|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
635577|NCT00435162|B1|Baseline|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
635578|NCT00435162|P6|Participant Flow|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then placebo
635579|NCT00435162|P5|Participant Flow|High Dose in Both Periods|Valsartan 1.0 mg/kg, then placebo
635587|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
635589|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
635590|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
635591|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
635592|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
635593|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
635594|NCT00435162|E6|Reported Event|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then Placebo
635595|NCT00435162|E5|Reported Event|High Dose in Both Periods|Valsartan 4.0 mg/kg in both periods
635596|NCT00435162|E4|Reported Event|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then Placebo
635597|NCT00435162|E3|Reported Event|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
635598|NCT00435162|E2|Reported Event|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then Placebo
635599|NCT00435162|E1|Reported Event|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
635600|NCT00435045|B3|Baseline|Total|Total of all reporting groups
635601|NCT00435045|B2|Baseline|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635602|NCT00435045|B1|Baseline|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635603|NCT00435045|P2|Participant Flow|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635604|NCT00435045|P1|Participant Flow|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635605|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635606|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635607|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635608|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635609|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635610|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635611|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635612|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635613|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635614|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635615|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635616|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635617|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635618|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
638188|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
635619|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635620|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635621|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635622|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635623|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635624|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635625|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635626|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635627|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635628|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635629|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635630|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635631|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635632|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635633|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635634|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635635|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635636|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635637|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635638|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635639|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635640|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635828|NCT00434434|E1|Reported Event|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635641|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635642|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635643|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635644|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635645|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635646|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635647|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635648|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635649|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635650|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635651|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635652|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635653|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635654|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635655|NCT00435045|E2|Reported Event|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
635656|NCT00435045|E1|Reported Event|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
635657|NCT00435019|B3|Baseline|Total|Total of all reporting groups
635658|NCT00435019|B2|Baseline|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635659|NCT00435019|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635660|NCT00435019|P2|Participant Flow|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635661|NCT00435019|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635662|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635663|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635664|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635665|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635666|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
636003|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
635667|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635668|NCT00435019|E2|Reported Event|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635669|NCT00435019|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
635670|NCT00434993|B3|Baseline|Total|Total of all reporting groups
635671|NCT00434993|B2|Baseline|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635672|NCT00434993|B1|Baseline|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635673|NCT00434993|P2|Participant Flow|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635674|NCT00434993|P1|Participant Flow|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635675|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635676|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635677|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635678|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635679|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635680|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635681|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635682|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635683|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635684|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635685|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635686|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635687|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635688|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635689|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635690|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635691|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635692|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635693|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635694|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635695|NCT00434993|E2|Reported Event|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
635696|NCT00434993|E1|Reported Event|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
635697|NCT00434967|B5|Baseline|Total|Total of all reporting groups
635698|NCT00434967|B4|Baseline|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635699|NCT00434967|B3|Baseline|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
635700|NCT00434967|B2|Baseline|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635701|NCT00434967|B1|Baseline|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
635702|NCT00434967|P4|Participant Flow|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635703|NCT00434967|P3|Participant Flow|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
635704|NCT00434967|P2|Participant Flow|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635705|NCT00434967|P1|Participant Flow|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
635706|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635707|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
635708|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635741|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635709|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
635710|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635711|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
635712|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635713|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
635714|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635715|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
635716|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635717|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
635718|NCT00434967|E4|Reported Event|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635719|NCT00434967|E3|Reported Event|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
635720|NCT00434967|E2|Reported Event|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
635721|NCT00434967|E1|Reported Event|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
635722|NCT00434954|B3|Baseline|Total|Total of all reporting groups
635723|NCT00434954|B2|Baseline|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635724|NCT00434954|B1|Baseline|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635725|NCT00434954|P2|Participant Flow|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635726|NCT00434954|P1|Participant Flow|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635727|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635728|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635729|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635730|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635731|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635732|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635733|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635734|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635735|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635736|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635737|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635738|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635739|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635740|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635742|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635743|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635744|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635745|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635746|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635747|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635748|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635749|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635750|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635751|NCT00434954|E2|Reported Event|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
635752|NCT00434954|E1|Reported Event|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
635753|NCT00434876|B3|Baseline|Total|Total of all reporting groups
635754|NCT00434876|B2|Baseline|Placebo|Placebo
635755|NCT00434876|B1|Baseline|Quetiapine|Quetiapine XR
635756|NCT00434876|P2|Participant Flow|Placebo|The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
635757|NCT00434876|P1|Participant Flow|Quetiapine XR|The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
635758|NCT00434876|O2|Outcome|Placebo|Placebo
635759|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
635760|NCT00434876|O2|Outcome|Placebo|Placebo
635761|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
635762|NCT00434876|O2|Outcome|Placebo|Placebo
635763|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
635764|NCT00434876|O2|Outcome|Placebo|Placebo
635765|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
635766|NCT00434876|E2|Reported Event|Placebo|Placebo
635767|NCT00434876|E1|Reported Event|Quetiapine|Quetiapine XR
635768|NCT00434759|B3|Baseline|Total|Total of all reporting groups
635769|NCT00434759|B2|Baseline|Standardtherapy|standard therapy (therapist-guided intervention only)
635770|NCT00434759|B1|Baseline|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
635771|NCT00434759|P2|Participant Flow|Standardtherapy|standard therapy (therapist-guided intervention only)
635772|NCT00434759|P1|Participant Flow|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
635773|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
635774|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
635775|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
635776|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
635777|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
635778|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
635779|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
635780|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
635781|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only; 16 sessions)
635782|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
635783|NCT00434759|E2|Reported Event|Standardtherapy|standard therapy (therapist-guided intervention only)
635784|NCT00434759|E1|Reported Event|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
635785|NCT00434642|B3|Baseline|Total|Total of all reporting groups
635786|NCT00434642|B2|Baseline|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
635787|NCT00434642|B1|Baseline|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635788|NCT00434642|P2|Participant Flow|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
635789|NCT00434642|P1|Participant Flow|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635790|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635791|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
635792|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635793|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
635794|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635795|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
635796|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635797|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
635798|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635799|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
635827|NCT00434434|E2|Reported Event|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635800|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635801|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
635802|NCT00434642|E2|Reported Event|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
635803|NCT00434642|E1|Reported Event|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
635804|NCT00434590|B3|Baseline|Total|Total of all reporting groups
635805|NCT00434590|B2|Baseline|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
635806|NCT00434590|B1|Baseline|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
635807|NCT00434590|P2|Participant Flow|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
635808|NCT00434590|P1|Participant Flow|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
635809|NCT00434590|O2|Outcome|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
635810|NCT00434590|O1|Outcome|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
635811|NCT00434590|E2|Reported Event|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
635812|NCT00434590|E1|Reported Event|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
635813|NCT00434434|B4|Baseline|Total|Total of all reporting groups
635814|NCT00434434|B3|Baseline|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635815|NCT00434434|B2|Baseline|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635816|NCT00434434|B1|Baseline|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635817|NCT00434434|P3|Participant Flow|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635818|NCT00434434|P2|Participant Flow|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635819|NCT00434434|P1|Participant Flow|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635820|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635821|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635822|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635823|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635824|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635825|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635826|NCT00434434|E3|Reported Event|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
635829|NCT00434421|B1|Baseline|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
635830|NCT00434421|P1|Participant Flow|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
635831|NCT00434421|O1|Outcome|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
635832|NCT00434421|E1|Reported Event|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
635833|NCT00434356|B3|Baseline|Total|Total of all reporting groups
635834|NCT00434356|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
635835|NCT00434356|B1|Baseline|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635836|NCT00434356|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
635837|NCT00434356|P1|Participant Flow|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635838|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
635839|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635840|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635841|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
635842|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635843|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
635844|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635845|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
635846|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635847|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
636004|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
635848|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635849|NCT00434356|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
635850|NCT00434356|E1|Reported Event|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
635851|NCT00434330|B7|Baseline|Total|Total of all reporting groups
635852|NCT00434330|B6|Baseline|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635853|NCT00434330|B5|Baseline|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635854|NCT00434330|B4|Baseline|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635855|NCT00434330|B3|Baseline|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635856|NCT00434330|B2|Baseline|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635857|NCT00434330|B1|Baseline|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635858|NCT00434330|P6|Participant Flow|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635859|NCT00434330|P5|Participant Flow|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635860|NCT00434330|P4|Participant Flow|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635861|NCT00434330|P3|Participant Flow|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635862|NCT00434330|P2|Participant Flow|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635863|NCT00434330|P1|Participant Flow|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635864|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635865|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635942|NCT00434252|B2|Baseline|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635866|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635867|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635868|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635869|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635870|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635871|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635872|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635873|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635874|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635875|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635876|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635877|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635878|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635879|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635880|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635881|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635882|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
636005|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
635883|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635884|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635885|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635886|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635887|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635888|NCT00434330|E6|Reported Event|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635889|NCT00434330|E5|Reported Event|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635890|NCT00434330|E4|Reported Event|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635891|NCT00434330|E3|Reported Event|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
635892|NCT00434330|E2|Reported Event|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635893|NCT00434330|E1|Reported Event|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
635894|NCT00434304|B1|Baseline|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635895|NCT00434304|P1|Participant Flow|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635896|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635897|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
636006|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
649783|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
635898|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635899|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635900|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635901|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635902|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635903|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635904|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635905|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635906|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635907|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635908|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635943|NCT00434252|B1|Baseline|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
636007|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
649784|NCT00402987|O4|Outcome|Placebo|
635909|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635910|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635911|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635912|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635913|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635914|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635915|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635916|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635917|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635918|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635919|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635944|NCT00434252|P2|Participant Flow|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
636008|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
649785|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
635920|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635921|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635922|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635923|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635924|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635925|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635926|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635927|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635928|NCT00434304|E2|Reported Event|Ropinirole PR/XR (Taper Phase)|The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
635929|NCT00434304|E1|Reported Event|Ropinirole PR/XR (Treatment Phase)|Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52.
635930|NCT00434278|B3|Baseline|Total|Total of all reporting groups
635931|NCT00434278|B2|Baseline|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635932|NCT00434278|B1|Baseline|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635933|NCT00434278|P2|Participant Flow|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635934|NCT00434278|P1|Participant Flow|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635935|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635936|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635937|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635938|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635939|NCT00434278|E2|Reported Event|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635940|NCT00434278|E1|Reported Event|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
635941|NCT00434252|B3|Baseline|Total|Total of all reporting groups
635967|NCT00434226|P2|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
635945|NCT00434252|P1|Participant Flow|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635946|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635947|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635948|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635949|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635950|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635951|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635952|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635953|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635954|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635955|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635956|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635957|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635958|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635959|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635960|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635961|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635962|NCT00434252|E2|Reported Event|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
635963|NCT00434252|E1|Reported Event|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
635964|NCT00434226|B3|Baseline|Total|Total of all reporting groups
635965|NCT00434226|B2|Baseline|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
635966|NCT00434226|B1|Baseline|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
635968|NCT00434226|P1|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
635969|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
635970|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
635971|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
635972|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
635973|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
635974|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
635975|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
635976|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
635977|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
635978|NCT00434213|B1|Baseline|Daytrana|Methylphenidate Transdermal System (MTS)
635979|NCT00434213|P1|Participant Flow|Daytrana|Methylphenidate Transdermal System (MTS)
635980|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
635981|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
635982|NCT00434213|E1|Reported Event|Daytrana|Methylphenidate Transdermal System (MTS)
635983|NCT00434161|B4|Baseline|Total|Total of all reporting groups
635984|NCT00434161|B3|Baseline|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
635985|NCT00434161|B2|Baseline|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
635986|NCT00434161|B1|Baseline|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
635987|NCT00434161|P3|Participant Flow|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy
635988|NCT00434161|P2|Participant Flow|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of placebo as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy.
635989|NCT00434161|P1|Participant Flow|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and placebo on Days 0, 1 and 2 after high dose chemotherapy.
635990|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
635991|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
635992|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
635993|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
635994|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
635995|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
635996|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
635997|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
635998|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
635999|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
636000|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
636001|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636002|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
636009|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
636010|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
636011|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
636012|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636013|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
636014|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636015|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
636016|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636017|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
636018|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
636019|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636020|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
636021|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
636022|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636023|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
636024|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
636025|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636026|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
636027|NCT00434161|E3|Reported Event|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.
636028|NCT00434161|E2|Reported Event|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
636029|NCT00434161|E1|Reported Event|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.
636030|NCT00434148|B3|Baseline|Total|Total of all reporting groups
636031|NCT00434148|B2|Baseline|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636032|NCT00434148|B1|Baseline|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636033|NCT00434148|P2|Participant Flow|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636034|NCT00434148|P1|Participant Flow|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636035|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636073|NCT00434122|O2|Outcome|Degarelix Follicular, 2.5 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6
636036|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636037|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636038|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636039|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636040|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636041|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636042|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636043|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636044|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636045|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636046|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636074|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
636197|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636047|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636048|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636049|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636050|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636051|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636052|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636053|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636054|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636055|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636056|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636057|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636075|NCT00434122|O2|Outcome|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
636058|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636059|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636060|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636061|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636062|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636063|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636064|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
636065|NCT00434148|E2|Reported Event|Pasireotide 900 ug|At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636066|NCT00434148|E1|Reported Event|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
636067|NCT00434122|B3|Baseline|Total|Total of all reporting groups
636068|NCT00434122|B2|Baseline|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
636069|NCT00434122|B1|Baseline|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
636070|NCT00434122|P2|Participant Flow|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
636071|NCT00434122|P1|Participant Flow|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
636072|NCT00434122|O3|Outcome|Ganirelix, 0.25 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
636076|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
636077|NCT00434122|E2|Reported Event|Ganirelix, 0.25 mg|Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
636078|NCT00434122|E1|Reported Event|Degarelix, 2.5 mg|"Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg.~Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.~Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6."
636079|NCT00434109|B1|Baseline|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636080|NCT00434109|P1|Participant Flow|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636081|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636082|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636083|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636084|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636085|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636086|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636087|NCT00434109|E1|Reported Event|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
636088|NCT00434057|B1|Baseline|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
636089|NCT00434057|P1|Participant Flow|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
636090|NCT00434057|O1|Outcome|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
636091|NCT00434057|E1|Reported Event|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
636092|NCT00434018|B3|Baseline|Total|Total of all reporting groups
636093|NCT00434018|B2|Baseline|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636094|NCT00434018|B1|Baseline|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636095|NCT00434018|P2|Participant Flow|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636096|NCT00434018|P1|Participant Flow|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636097|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636098|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636099|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636100|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636101|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636102|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636189|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636103|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636104|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636105|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636106|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636107|NCT00434018|O2|Outcome|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636108|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
636109|NCT00434018|E2|Reported Event|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
636110|NCT00434018|E1|Reported Event|Wheelchair Skills Training|Wheelchair Skills Training: Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
636111|NCT00433992|B3|Baseline|Total|Total of all reporting groups
636112|NCT00433992|B2|Baseline|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
636113|NCT00433992|B1|Baseline|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
636114|NCT00433992|P2|Participant Flow|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
636115|NCT00433992|P1|Participant Flow|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
636116|NCT00433992|O2|Outcome|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
636117|NCT00433992|O1|Outcome|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
636118|NCT00433992|O4|Outcome|ATV/r +ABC/3TC|HIV-infected subjects taking atazanavir-ritonavir with abacavir-lamivudine at baseline
636119|NCT00433992|O3|Outcome|ATV/r +TDF/FTC|HIV infected subjects taking atazanavir-ritonavir with tenofovir DF-emtricitabine at baseline
636120|NCT00433992|O2|Outcome|TDF/FTC+EFV|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with Efavirenz at baseline
636121|NCT00433992|O1|Outcome|ABC/3TC+EFV|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) with Efavirenz at baseline
636122|NCT00433992|E2|Reported Event|TDF/FTC|HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)
636123|NCT00433992|E1|Reported Event|ABC/3TC|HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)
636124|NCT00433966|B3|Baseline|Total|Total of all reporting groups
636125|NCT00433966|B2|Baseline|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636126|NCT00433966|B1|Baseline|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636127|NCT00433966|P4|Participant Flow|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636128|NCT00433966|P3|Participant Flow|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636190|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636315|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636129|NCT00433966|P2|Participant Flow|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636130|NCT00433966|P1|Participant Flow|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636131|NCT00433966|O2|Outcome|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636132|NCT00433966|O1|Outcome|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636133|NCT00433966|O2|Outcome|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636134|NCT00433966|O1|Outcome|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636135|NCT00433966|O2|Outcome|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636136|NCT00433966|O1|Outcome|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636137|NCT00433966|O2|Outcome|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636191|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636192|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636138|NCT00433966|O1|Outcome|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636139|NCT00433966|O2|Outcome|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636140|NCT00433966|O1|Outcome|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636141|NCT00433966|O2|Outcome|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636142|NCT00433966|O1|Outcome|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636143|NCT00433966|O2|Outcome|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636144|NCT00433966|O1|Outcome|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636145|NCT00433966|E4|Reported Event|Stent Arm - Bare Metal Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636146|NCT00433966|E3|Reported Event|Stent Arm - Paclitaxel-Eluting Stent|"To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in:~reduced rates of target lesion revascularization for ischemia at 1 year~similar rates of death, reinfarction, stroke or stent thrombosis at 1 year~lower rates of analysis segment binary angiographic restenosis at 13 months~Bare metal stent: Uncoated bare metal stent~Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent"
636147|NCT00433966|E2|Reported Event|Pharmacology Arm - Unfractionated Heparin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636193|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636194|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636195|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636196|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636148|NCT00433966|E1|Reported Event|Pharmacology Arm - Bivalirudin|"To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in:~reduced rates of major bleeding events at 30 days~similar rates of major adverse ischemic cardiac events at 30 days~reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days.~Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room).~Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room)."
636149|NCT00433914|B3|Baseline|Total|Total of all reporting groups
636150|NCT00433914|B2|Baseline|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636151|NCT00433914|B1|Baseline|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636152|NCT00433914|P2|Participant Flow|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636153|NCT00433914|P1|Participant Flow|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636154|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636155|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636156|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636157|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636158|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636159|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636160|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636161|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636162|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636163|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636164|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636165|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636166|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636167|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636168|NCT00433914|E2|Reported Event|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636169|NCT00433914|E1|Reported Event|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
636170|NCT00433836|B3|Baseline|Total|Total of all reporting groups
636171|NCT00433836|B2|Baseline|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
636172|NCT00433836|B1|Baseline|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
636173|NCT00433836|P2|Participant Flow|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
636174|NCT00433836|P1|Participant Flow|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
636175|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
636176|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
636177|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
636178|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
636179|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
636180|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
636181|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
636182|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
636183|NCT00433836|E2|Reported Event|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
636184|NCT00433836|E1|Reported Event|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
636185|NCT00433771|B1|Baseline|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636186|NCT00433771|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636187|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636188|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
638189|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
636198|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636199|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636200|NCT00433771|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
636201|NCT00433745|B1|Baseline|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
636202|NCT00433745|P1|Participant Flow|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
636203|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|"All 4 patients who were accrued went on to receive the vaccine.~Complete Response (CR): defined as an absolute neutrophil count of ≥500/µL, platelet count of ≥75,000/µL, no leukemic blasts in the blood nor evidence of extramedullary leukemia, bone marrow (BM) with a cellularity of more than 20%, maturation of all three cell lineages, no Auer rods, and less than 5% bone marrow blast cells.~Partial response (PR): 50% reduction in marrow blasts, with an absolute neutrophil count (ANC) greater than 500/µL, and platelet count greater than 75000/µL.~No response: subjects who did not meet the above response criteria were defined as non-responders."
636204|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
636205|NCT00433745|E1|Reported Event|WT1 Peptide Vaccine|All 4 patients who were accrued went on to receive the vaccine
636206|NCT00433654|B3|Baseline|Total|Total of all reporting groups
636207|NCT00433654|B2|Baseline|Control Group|The control group waited for one hour (did not have an MRI scan) at 9-12 weeks post-implant.
636208|NCT00433654|B1|Baseline|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636209|NCT00433654|P2|Participant Flow|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
636210|NCT00433654|P1|Participant Flow|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636211|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
636212|NCT00433654|O1|Outcome|5086 MRI Lead|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636213|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
636214|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636215|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
636216|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636217|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
636218|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636219|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
636220|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
636221|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
636222|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636223|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
636224|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636225|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636226|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636227|NCT00433654|O1|Outcome|Implanted Subjects|All subjects undergoing an implant attempt
636228|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
636229|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636230|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
636231|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636232|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
636233|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636234|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
636235|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636236|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636237|NCT00433654|E3|Reported Event|Non-randomized|Some subjects were enrolled, but either did not receive a system, or received only a partial system, and were not randomized. Their adverse events were collected until they exited the study.
636238|NCT00433654|E2|Reported Event|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
636239|NCT00433654|E1|Reported Event|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
636240|NCT00433550|B4|Baseline|Total|Total of all reporting groups
636241|NCT00433550|B3|Baseline|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
636242|NCT00433550|B2|Baseline|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
636243|NCT00433550|B1|Baseline|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
649786|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
636244|NCT00433550|P3|Participant Flow|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
636245|NCT00433550|P2|Participant Flow|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
636246|NCT00433550|P1|Participant Flow|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
636247|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15 > > Group 2 (6/7 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15. >~> Group 3 (7/7 UGT1A1 genotype): > Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
636248|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15 > > Group 2 (6/7 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15. >~> Group 3 (7/7 UGT1A1 genotype): > Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
636249|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype):~> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15~>~>~Group 2 (6/7 UGT1A1 genotype):~> Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15.~>~>~Group 3 (7/7 UGT1A1 genotype):~> Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
636250|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15 > > Group 2 (6/7 UGT1A1 genotype): > Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15. >~> Group 3 (7/7 UGT1A1 genotype): > Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
636251|NCT00433550|O1|Outcome|All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)|"Group 1 (6/6 UGT1A1 genotype):~Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15~Group 2 (6/7 UGT1A1 genotype):~Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15.~Group 3 (7/7 UGT1A1 genotype):~Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15"
636252|NCT00433550|E3|Reported Event|Group 3 (7/7 UGT1A1 Genotype)|Patients receive 75 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
636253|NCT00433550|E2|Reported Event|Group 2 (6/7 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m^2/day capecitabine PO BID on days 2-15
636254|NCT00433550|E1|Reported Event|Group 1 (6/6 UGT1A1 Genotype)|Patients receive 150 mg/m^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m^2/day capecitabine PO BID on days 2-15
636255|NCT00433537|B1|Baseline|Step 1 - VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
636256|NCT00433537|P3|Participant Flow|VcR-CVAD Induction Then Off Study|Patients received VcR-CVAD induction but did not proceed to step 2 treatment for various reasons.
636257|NCT00433537|P2|Participant Flow|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
636258|NCT00433537|P1|Participant Flow|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneous (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
636259|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
636260|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
636261|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
636262|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
636263|NCT00433537|O1|Outcome|VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
636264|NCT00433537|E2|Reported Event|Step 2 - Maintenance Rituximab|All patients who received maintenance rituximab.
636265|NCT00433537|E1|Reported Event|Step 1 - VcR-CVAD Induction|All patients who received VcR-CVAD induction.
636266|NCT00433446|B1|Baseline|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636267|NCT00433446|P1|Participant Flow|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636268|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636269|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636270|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636271|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636272|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636273|NCT00433446|E1|Reported Event|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
636274|NCT00433381|B3|Baseline|Total|Total of all reporting groups
636275|NCT00433381|B2|Baseline|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
636276|NCT00433381|B1|Baseline|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
636277|NCT00433381|P2|Participant Flow|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
636278|NCT00433381|P1|Participant Flow|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
636279|NCT00433381|O1|Outcome|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
636280|NCT00433381|O1|Outcome|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as definted by stable or responding tumor.
649787|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
636281|NCT00433381|E2|Reported Event|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients.
636282|NCT00433381|E1|Reported Event|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60.
636283|NCT00433329|B1|Baseline|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
636284|NCT00433329|P1|Participant Flow|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
636285|NCT00433329|O1|Outcome|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
636286|NCT00433329|E1|Reported Event|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
636287|NCT00433290|B3|Baseline|Total|Total of all reporting groups
636288|NCT00433290|B2|Baseline|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636289|NCT00433290|B1|Baseline|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636290|NCT00433290|P2|Participant Flow|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636291|NCT00433290|P1|Participant Flow|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636292|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636293|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636294|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636295|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636296|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636297|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636298|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636299|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636300|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636301|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636302|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636303|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636304|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636305|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636306|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636307|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636308|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636309|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636310|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636311|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636312|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636313|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636314|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636316|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636317|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636318|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636319|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636320|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636321|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636322|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636323|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636324|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636325|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636326|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636327|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636328|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636329|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636330|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636331|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636332|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636333|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636334|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636335|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636336|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636337|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636338|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636339|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636340|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636341|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636342|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636343|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636344|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636345|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636346|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636347|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636348|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636349|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636350|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636351|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636352|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636353|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636407|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
649788|NCT00402987|O3|Outcome|Placebo|
636354|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636355|NCT00433290|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
636356|NCT00433290|E1|Reported Event|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
636357|NCT00433199|B3|Baseline|Total|Total of all reporting groups
636358|NCT00433199|B2|Baseline|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
636359|NCT00433199|B1|Baseline|Placebo|Placebo comparator administered during the Double-Blind period only
636360|NCT00433199|P2|Participant Flow|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
636361|NCT00433199|P1|Participant Flow|Placebo|Placebo comparator administered during the Double-Blind period only
636362|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
636363|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
636364|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
636365|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
636366|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo group given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
636367|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
636368|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
636369|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
636370|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
636371|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
636372|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
636373|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
636374|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
636375|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
636376|NCT00433199|E2|Reported Event|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
636377|NCT00433199|E1|Reported Event|Placebo|Placebo comparator administered during the Double-Blind period only
636378|NCT00433160|B3|Baseline|Total|Total of all reporting groups
636379|NCT00433160|B2|Baseline|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636380|NCT00433160|B1|Baseline|Teriparatide|20 micrograms for 104 weeks
636381|NCT00433160|P2|Participant Flow|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636382|NCT00433160|P1|Participant Flow|Teriparatide|20 micrograms for 104 weeks
636383|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636384|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636385|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636386|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636387|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636388|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636389|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636390|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636391|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636392|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636393|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636394|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636395|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636396|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636397|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636398|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636399|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636400|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636401|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636402|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636403|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636404|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636405|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636406|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636408|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636409|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636410|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636411|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636412|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636413|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636414|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636415|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636416|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636417|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636418|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636419|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636420|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636421|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636422|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
636423|NCT00433160|E6|Reported Event|Placebo (During 104 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636424|NCT00433160|E5|Reported Event|Teriparatide (During 104 Weeks)|20 micrograms for 104 weeks
636425|NCT00433160|E4|Reported Event|Placebo (During 76 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636426|NCT00433160|E3|Reported Event|Teriparatide (During 76 Weeks)|20 micrograms for 104 weeks
636427|NCT00433160|E2|Reported Event|Placebo (During 52 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
636428|NCT00433160|E1|Reported Event|Teriparatide (During 52 Weeks)|20 micrograms for 104 weeks
636429|NCT00433017|B3|Baseline|Total|Total of all reporting groups
636430|NCT00433017|B2|Baseline|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636431|NCT00433017|B1|Baseline|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636432|NCT00433017|P2|Participant Flow|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636433|NCT00433017|P1|Participant Flow|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636434|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636435|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636525|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
649789|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
636436|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636437|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636438|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636439|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636440|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636441|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636442|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636443|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636444|NCT00433017|E2|Reported Event|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636445|NCT00433017|E1|Reported Event|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
636446|NCT00433004|B3|Baseline|Total|Total of all reporting groups
636447|NCT00433004|B2|Baseline|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): Postpartum TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRAPCETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
636448|NCT00433004|B1|Baseline|No Advance EC|No advance supply of emergency contraception
636449|NCT00433004|P2|Participant Flow|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
636450|NCT00433004|P1|Participant Flow|No Advance EC|No advance supply of emergency contraception
636451|NCT00433004|O2|Outcome|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
636452|NCT00433004|O1|Outcome|No Advance EC|No advance supply of emergency contraception
636453|NCT00433004|O2|Outcome|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
636454|NCT00433004|O1|Outcome|No Advance EC|No advance supply of emergency contraception
636455|NCT00433004|O2|Outcome|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
636456|NCT00433004|O1|Outcome|No Advance EC|No advance supply of emergency contraception
636457|NCT00433004|E2|Reported Event|Advance EC Given|"Advance supply of emergency contraception is given~Plan B (Levonorgestrel): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS."
636458|NCT00433004|E1|Reported Event|No Advance EC|No advance supply of emergency contraception
636459|NCT00432991|B3|Baseline|Total|Total of all reporting groups
636460|NCT00432991|B2|Baseline|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
636461|NCT00432991|B1|Baseline|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
636462|NCT00432991|P2|Participant Flow|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
636463|NCT00432991|P1|Participant Flow|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
636464|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
636465|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
636466|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
636467|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
636468|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
636469|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
636470|NCT00432991|E2|Reported Event|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
636471|NCT00432991|E1|Reported Event|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
636472|NCT00432965|B3|Baseline|Total|Total of all reporting groups
636473|NCT00432965|B2|Baseline|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
636474|NCT00432965|B1|Baseline|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
636475|NCT00432965|P2|Participant Flow|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
636476|NCT00432965|P1|Participant Flow|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
636477|NCT00432965|O2|Outcome|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
636478|NCT00432965|O1|Outcome|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
636479|NCT00432965|E2|Reported Event|Moist Wound Therapy|"Moist Wound Therapy (standard of care)~Moist Wound Therapy: Moist Wound Therapy (Standard of Care)"
636480|NCT00432965|E1|Reported Event|VAC Therapy|"Treatment of Diabetic Foot Ulcers with VAC Therapy~VAC Therapy: VAC Therapy"
636481|NCT00432835|B3|Baseline|Total|Total of all reporting groups
636482|NCT00432835|B2|Baseline|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
636483|NCT00432835|B1|Baseline|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
636484|NCT00432835|P2|Participant Flow|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
636485|NCT00432835|P1|Participant Flow|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
636486|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
636487|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
636488|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
636489|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
636490|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
636491|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
636492|NCT00432835|E2|Reported Event|Gastric StimulationNotActivated|Sham stimulation
636493|NCT00432835|E1|Reported Event|Gastric Stimactivated|Gastric Electrical Stimulation
636494|NCT00432809|B4|Baseline|Total|Total of all reporting groups
636495|NCT00432809|B3|Baseline|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636496|NCT00432809|B2|Baseline|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636497|NCT00432809|B1|Baseline|Medical Therapy|Intensive medical therapy for diabetes
636498|NCT00432809|P3|Participant Flow|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636499|NCT00432809|P2|Participant Flow|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636500|NCT00432809|P1|Participant Flow|Medical Therapy|Intensive medical therapy for diabetes
636501|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636502|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636503|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636504|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636505|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636506|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636507|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636508|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636509|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636510|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636511|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636512|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636513|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636514|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636515|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636516|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636517|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636518|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636519|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636520|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636521|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636522|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636523|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636524|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636526|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636527|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636528|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636529|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636530|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636531|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636532|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636533|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636534|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636535|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636536|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636537|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636538|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636539|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636540|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636541|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636542|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636543|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636544|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636545|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636546|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636547|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636548|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636549|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636550|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636551|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636552|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636553|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636554|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636555|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636556|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636557|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636558|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636559|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636560|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636561|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636562|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636563|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636564|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636565|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636566|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
636567|NCT00432809|E3|Reported Event|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
636568|NCT00432809|E2|Reported Event|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
636569|NCT00432809|E1|Reported Event|Medical Therapy|Intensive medical therapy for diabetes
636570|NCT00432744|B3|Baseline|Total|Total of all reporting groups
636571|NCT00432744|B2|Baseline|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
636593|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
637322|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
636572|NCT00432744|B1|Baseline|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
636573|NCT00432744|P2|Participant Flow|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
636574|NCT00432744|P1|Participant Flow|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
636575|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
636576|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
636577|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
636578|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
636579|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
636580|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
636581|NCT00432744|E2|Reported Event|Placebo|Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group. (Either in Period 1 or Period 2)
636582|NCT00432744|E1|Reported Event|CoenzymeQ10|CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed. (Either in Period 1 or Period 2)
636583|NCT00432666|B3|Baseline|Total|Total of all reporting groups
636584|NCT00432666|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636585|NCT00432666|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636586|NCT00432666|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636587|NCT00432666|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636588|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636589|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636590|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636591|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636592|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
637365|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
636594|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636595|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636596|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636597|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636598|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636599|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636600|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636601|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636602|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636603|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636604|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636605|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636606|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636607|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636608|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636609|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636610|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636611|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636612|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636613|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636614|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636615|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636616|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636617|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636618|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636619|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636620|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636621|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636622|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
637366|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
636623|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636624|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636625|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636626|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636627|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636628|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636629|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636630|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636631|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636632|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636633|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636634|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636635|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636636|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636637|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636638|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636639|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636640|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636641|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636642|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636643|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636644|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636645|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636646|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636647|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636648|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636649|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636650|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636651|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
637323|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
636652|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636653|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636654|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636655|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636656|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636657|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636658|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636659|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636660|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636661|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636662|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636663|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636664|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636665|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636666|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636667|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636668|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636669|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636670|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636671|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636672|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636673|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636674|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636675|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636676|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636677|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636678|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636679|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636680|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
637417|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
636681|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636682|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636683|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636684|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636685|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636686|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636687|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636688|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636689|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636690|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636691|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636692|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636693|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636694|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636695|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636696|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636697|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636698|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636699|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636700|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636701|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636702|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636703|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636704|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636705|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636706|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636707|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636708|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636709|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
637324|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
636710|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636711|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636712|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636713|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636714|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636715|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636716|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636717|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636718|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636719|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636720|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636721|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636722|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636723|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636724|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636725|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636726|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636727|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636728|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636729|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636730|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636731|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636732|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636733|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636734|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636735|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636736|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636737|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636738|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
637418|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
636739|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636740|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636741|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636742|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636743|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636744|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636745|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636746|NCT00432666|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
636747|NCT00432666|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
636748|NCT00432601|B3|Baseline|Total|Total of all reporting groups
636749|NCT00432601|B2|Baseline|Arm 2|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636750|NCT00432601|B1|Baseline|Arm 1|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636751|NCT00432601|P2|Participant Flow|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636752|NCT00432601|P1|Participant Flow|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636753|NCT00432601|O2|Outcome|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636754|NCT00432601|O1|Outcome|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636755|NCT00432601|E2|Reported Event|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636756|NCT00432601|E1|Reported Event|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
636757|NCT00432562|B3|Baseline|Total|Total of all reporting groups
636758|NCT00432562|B2|Baseline|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
636759|NCT00432562|B1|Baseline|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
636760|NCT00432562|P2|Participant Flow|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
636761|NCT00432562|P1|Participant Flow|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
636762|NCT00432562|O2|Outcome|Navelbine|
636763|NCT00432562|O1|Outcome|ANX-530|
636764|NCT00432562|O2|Outcome|Navelbine|
636765|NCT00432562|O1|Outcome|ANX-530|
636766|NCT00432562|O2|Outcome|Navelbine|
636767|NCT00432562|O1|Outcome|ANX-530|
636768|NCT00432562|O2|Outcome|Navelbine|
636769|NCT00432562|O1|Outcome|ANX-530|
636770|NCT00432562|O2|Outcome|Navelbine|
636771|NCT00432562|O1|Outcome|ANX-530|
636772|NCT00432562|O2|Outcome|Navelbine|
636773|NCT00432562|O1|Outcome|ANX-530|
636774|NCT00432562|O2|Outcome|Navelbine|
636775|NCT00432562|O1|Outcome|ANX-530|
636776|NCT00432562|O2|Outcome|Navelbine|
636777|NCT00432562|O1|Outcome|ANX-530|
636778|NCT00432562|O2|Outcome|Navelbine|
636779|NCT00432562|O1|Outcome|ANX-530|
636780|NCT00432562|O2|Outcome|Navelbine|
636781|NCT00432562|O1|Outcome|ANX-530|
636882|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
649790|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
636782|NCT00432562|E2|Reported Event|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
636783|NCT00432562|E1|Reported Event|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
636784|NCT00432458|B3|Baseline|Total|Total of all reporting groups
636785|NCT00432458|B2|Baseline|Arm II: ZLD|Zoledronic acid (ZLD)
636786|NCT00432458|B1|Baseline|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636787|NCT00432458|P2|Participant Flow|Arm II: ZLD|Zoledronic acid (ZLD)
636788|NCT00432458|P1|Participant Flow|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636789|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
636790|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636791|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
636792|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636793|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
636794|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636795|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
636796|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636797|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
636798|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636799|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
636800|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636801|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
636802|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636803|NCT00432458|E2|Reported Event|Arm II: ZLD|Zoledronic acid (ZLD)
636804|NCT00432458|E1|Reported Event|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
636805|NCT00432445|B1|Baseline|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
636806|NCT00432445|P1|Participant Flow|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
636807|NCT00432445|O1|Outcome|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
636808|NCT00432445|E1|Reported Event|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
636809|NCT00432380|B4|Baseline|Total|Total of all reporting groups
636810|NCT00432380|B3|Baseline|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636811|NCT00432380|B2|Baseline|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636812|NCT00432380|B1|Baseline|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636813|NCT00432380|P3|Participant Flow|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636814|NCT00432380|P2|Participant Flow|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636815|NCT00432380|P1|Participant Flow|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636816|NCT00432380|O3|Outcome|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636817|NCT00432380|O2|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
637325|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
636818|NCT00432380|O1|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636819|NCT00432380|O3|Outcome|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636820|NCT00432380|O2|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636821|NCT00432380|O1|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636822|NCT00432380|O3|Outcome|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636823|NCT00432380|O2|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636824|NCT00432380|O1|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636825|NCT00432380|O3|Outcome|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636826|NCT00432380|O2|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636827|NCT00432380|O1|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636828|NCT00432380|O3|Outcome|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636829|NCT00432380|O2|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636830|NCT00432380|O1|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636831|NCT00432380|O2|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636832|NCT00432380|O1|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636833|NCT00432380|O1|Outcome|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636834|NCT00432380|O1|Outcome|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636835|NCT00432380|E3|Reported Event|Placebo Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636836|NCT00432380|E2|Reported Event|Rotarix-Placebo-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636969|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636837|NCT00432380|E1|Reported Event|Placebo-Rotarix-Rotarix Group|Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
636838|NCT00432341|B3|Baseline|Total|Total of all reporting groups
636839|NCT00432341|B2|Baseline|Dysport®|Botulinum toxin type A (Dysport®)
636840|NCT00432341|B1|Baseline|BOTOX®|Botulinum toxin type A (BOTOX®)
636841|NCT00432341|P2|Participant Flow|Dysport®|Botulinum toxin type A (Dysport®)
636842|NCT00432341|P1|Participant Flow|BOTOX®|Botulinum toxin type A (BOTOX®)
636843|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636844|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636845|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636846|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636847|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636848|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636849|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636850|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636851|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636852|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636853|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636854|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636855|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636856|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636857|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636858|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636859|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636860|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636861|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
636862|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
636863|NCT00432341|E2|Reported Event|Dysport®|Botulinum toxin type A (Dysport®)
636864|NCT00432341|E1|Reported Event|BOTOX®|Botulinum toxin type A (BOTOX®)
636865|NCT00432276|B3|Baseline|Total|Total of all reporting groups
636866|NCT00432276|B2|Baseline|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636867|NCT00432276|B1|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636868|NCT00432276|P2|Participant Flow|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636869|NCT00432276|P1|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636870|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636871|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636872|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636873|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636874|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636875|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636876|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636877|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636878|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636879|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636880|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636881|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636970|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636883|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636884|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636885|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636886|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636887|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636888|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636889|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636890|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636891|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636892|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636893|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636894|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636895|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636896|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636897|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636898|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636899|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636900|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636901|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636902|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636903|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636904|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636905|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636906|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636907|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636908|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636909|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636910|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
649791|NCT00402987|O4|Outcome|Placebo|
636911|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636912|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636913|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636914|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636915|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636916|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636917|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636918|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636919|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636920|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636921|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636922|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636923|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636924|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636925|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636926|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636927|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636928|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636929|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636930|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636931|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636932|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636933|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636934|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636935|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636936|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636937|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636938|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
649792|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
636939|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636940|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636941|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636942|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636943|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636944|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636945|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636946|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636947|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636948|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636949|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636950|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636951|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636952|NCT00432276|E2|Reported Event|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636953|NCT00432276|E1|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
636954|NCT00432237|B5|Baseline|Total|Total of all reporting groups
636955|NCT00432237|B4|Baseline|Placebo|"Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
636956|NCT00432237|B3|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
636957|NCT00432237|B2|Baseline|MK0974 150 mg|"MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
636958|NCT00432237|B1|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
636959|NCT00432237|P4|Participant Flow|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636960|NCT00432237|P3|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636961|NCT00432237|P2|Participant Flow|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636962|NCT00432237|P1|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636963|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636964|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636965|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636966|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636967|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636968|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
637141|NCT00431951|B1|Baseline|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
636971|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636972|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636973|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636974|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636975|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636976|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636977|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636978|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636979|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636980|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636981|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636982|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636983|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636984|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636985|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636986|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636987|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636988|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636989|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636990|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636991|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636992|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636993|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636994|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636995|NCT00432237|E4|Reported Event|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
636996|NCT00432237|E3|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
636997|NCT00432237|E2|Reported Event|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
636998|NCT00432237|E1|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
636999|NCT00432159|B6|Baseline|Total|Total of all reporting groups
637000|NCT00432159|B5|Baseline|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637001|NCT00432159|B4|Baseline|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637002|NCT00432159|B3|Baseline|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637003|NCT00432159|B2|Baseline|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637004|NCT00432159|B1|Baseline|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637005|NCT00432159|P5|Participant Flow|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637006|NCT00432159|P4|Participant Flow|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637007|NCT00432159|P3|Participant Flow|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637008|NCT00432159|P2|Participant Flow|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637009|NCT00432159|P1|Participant Flow|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637010|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637011|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637012|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637013|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637014|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637015|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637016|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637017|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637018|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637019|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637020|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637021|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637022|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637023|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637024|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637025|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637326|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637026|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637027|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637028|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637029|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637030|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637031|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637032|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637033|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637034|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637035|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637036|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637037|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637038|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637039|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637040|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637041|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637042|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637043|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637044|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637045|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637046|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637142|NCT00431951|P4|Participant Flow|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637047|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637048|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637049|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637050|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637051|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637052|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637053|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637054|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637055|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637056|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637057|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637058|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637059|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637060|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637061|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637062|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637063|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637064|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637065|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637066|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637067|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637143|NCT00431951|P3|Participant Flow|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637068|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637069|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637070|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637071|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637072|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637073|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637074|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637075|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637076|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637077|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637078|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637079|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637080|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637081|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637082|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637083|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637084|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637085|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637086|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637087|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637088|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637144|NCT00431951|P2|Participant Flow|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637089|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637090|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637091|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637092|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637093|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637094|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637095|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637096|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637097|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637098|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637099|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637100|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637101|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637102|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637103|NCT00432159|O4|Outcome|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637104|NCT00432159|O3|Outcome|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637105|NCT00432159|O2|Outcome|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637106|NCT00432159|O1|Outcome|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637107|NCT00432159|E5|Reported Event|Training: 1 & 2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637108|NCT00432159|E4|Reported Event|2-level ACDF|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637109|NCT00432159|E3|Reported Event|2-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637145|NCT00431951|P1|Participant Flow|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
649793|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
637110|NCT00432159|E2|Reported Event|1-level ACDF With Plate|Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
637111|NCT00432159|E1|Reported Event|1-level Cervical TDR|Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
637112|NCT00432042|B4|Baseline|Total|Total of all reporting groups
637113|NCT00432042|B3|Baseline|Arm 3: Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637114|NCT00432042|B2|Baseline|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637115|NCT00432042|B1|Baseline|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637116|NCT00432042|P3|Participant Flow|Arm 3: Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637117|NCT00432042|P2|Participant Flow|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637118|NCT00432042|P1|Participant Flow|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637119|NCT00432042|O2|Outcome|Arm 3: Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637120|NCT00432042|O1|Outcome|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637121|NCT00432042|O2|Outcome|Arm 3: Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637122|NCT00432042|O1|Outcome|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637123|NCT00432042|O2|Outcome|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637124|NCT00432042|O1|Outcome|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637125|NCT00432042|E3|Reported Event|Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637126|NCT00432042|E2|Reported Event|Arm 2: ProQuad®|Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637127|NCT00432042|E1|Reported Event|Arm 1: ProQuad® + Infanrix® Hexa|Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
637128|NCT00431964|B3|Baseline|Total|Total of all reporting groups
637129|NCT00431964|B2|Baseline|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637130|NCT00431964|B1|Baseline|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637131|NCT00431964|P2|Participant Flow|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637132|NCT00431964|P1|Participant Flow|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637133|NCT00431964|O2|Outcome|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637134|NCT00431964|O1|Outcome|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637135|NCT00431964|E2|Reported Event|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637136|NCT00431964|E1|Reported Event|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
637137|NCT00431951|B5|Baseline|Total|Total of all reporting groups
637138|NCT00431951|B4|Baseline|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637139|NCT00431951|B3|Baseline|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637140|NCT00431951|B2|Baseline|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
649794|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
637146|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637147|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637148|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637149|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637150|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637151|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637152|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637153|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637154|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637155|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637156|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637157|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637158|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637159|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637160|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637161|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637162|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637163|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637164|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637165|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637166|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637167|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637168|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637169|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637170|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637171|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637172|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637173|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637174|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637175|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637176|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637177|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637178|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637179|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637180|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637181|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637182|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637183|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637184|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637185|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637186|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637187|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637188|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637189|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637190|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637191|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637192|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637193|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637194|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
637195|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637196|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637197|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637198|NCT00431951|E4|Reported Event|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
637199|NCT00431951|E3|Reported Event|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637200|NCT00431951|E2|Reported Event|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
637201|NCT00431951|E1|Reported Event|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
637202|NCT00431847|B5|Baseline|Total|Total of all reporting groups
637203|NCT00431847|B4|Baseline|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637204|NCT00431847|B3|Baseline|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637205|NCT00431847|B2|Baseline|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637206|NCT00431847|B1|Baseline|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637207|NCT00431847|P5|Participant Flow|Unknown Treatment Status|No patient data on exposure to Regional Anesthesia
637208|NCT00431847|P4|Participant Flow|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637209|NCT00431847|P3|Participant Flow|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637210|NCT00431847|P2|Participant Flow|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637211|NCT00431847|P1|Participant Flow|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637212|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637213|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637214|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637215|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637216|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637217|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637218|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637219|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637220|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637221|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637222|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637223|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637224|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637225|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637226|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637227|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637228|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637229|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637230|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637231|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637232|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637233|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637234|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637235|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637236|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637237|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637238|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637239|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637240|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637241|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637242|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637243|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637244|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637245|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637246|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637247|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637248|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637249|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637250|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637320|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637251|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637252|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637253|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637254|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637255|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637256|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637257|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637258|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637259|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637260|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637261|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637262|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637263|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637264|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637265|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637266|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637267|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637268|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637269|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637270|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637271|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637272|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637273|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637274|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637275|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637276|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637277|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637278|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637321|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637279|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637280|NCT00431847|E4|Reported Event|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
637281|NCT00431847|E3|Reported Event|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
637282|NCT00431847|E2|Reported Event|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
637283|NCT00431847|E1|Reported Event|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
637284|NCT00431834|B1|Baseline|Entire Cohort|All subjects enrolled and treated with the Cardioblate Surgical Ablation System
637285|NCT00431834|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up.
637286|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|
637287|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.
637288|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed 6 month follow-up and had a 24-hour Holter assessment.
637289|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed a Holter assessment at 6 month follow-up.
637290|NCT00431834|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up.
637291|NCT00431626|B3|Baseline|Total|Total of all reporting groups
637292|NCT00431626|B2|Baseline|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
637293|NCT00431626|B1|Baseline|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
637294|NCT00431626|P2|Participant Flow|Placebo|
637295|NCT00431626|P1|Participant Flow|Treatment|
637296|NCT00431626|O2|Outcome|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
637297|NCT00431626|O1|Outcome|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
637298|NCT00431626|E2|Reported Event|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
637299|NCT00431626|E1|Reported Event|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
637300|NCT00431496|B1|Baseline|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637301|NCT00431496|P1|Participant Flow|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
637302|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637303|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637304|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637305|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637306|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637307|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637308|NCT00431496|E1|Reported Event|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
637309|NCT00431444|B3|Baseline|Total|Total of all reporting groups
637310|NCT00431444|B2|Baseline|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637311|NCT00431444|B1|Baseline|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637312|NCT00431444|P2|Participant Flow|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637313|NCT00431444|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637314|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637315|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637316|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637317|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637318|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637319|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637327|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637328|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637329|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637330|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637331|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637332|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637333|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637334|NCT00431444|E2|Reported Event|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
637335|NCT00431444|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
637336|NCT00431184|B3|Baseline|Total|Total of all reporting groups
637337|NCT00431184|B2|Baseline|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
637338|NCT00431184|B1|Baseline|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
637339|NCT00431184|P2|Participant Flow|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
637340|NCT00431184|P1|Participant Flow|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
637341|NCT00431184|O2|Outcome|Lorazepam|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Lorazepam.
637342|NCT00431184|O1|Outcome|Pentazocine|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Pentazocine.
637343|NCT00431184|O2|Outcome|Lorazepam|Subjects received 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later
637344|NCT00431184|O1|Outcome|Pentazocine|Subjects received 50mg of pentazocine
637345|NCT00431184|E2|Reported Event|Lorazepam|All subjects receive 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later on either Day 1 or Day 2.
637346|NCT00431184|E1|Reported Event|Pentazocine|All subjects receive 50mg of pentazocine followed by a second dose of 50mg two hours later on either Day 1 or Day 2.
637347|NCT00431132|B1|Baseline|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
637348|NCT00431132|P1|Participant Flow|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
637349|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
637350|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
637351|NCT00431132|E1|Reported Event|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
637352|NCT00431067|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637353|NCT00431067|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637354|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637355|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637356|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637357|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637358|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637359|NCT00431067|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
637360|NCT00431041|B3|Baseline|Total|Total of all reporting groups
637361|NCT00431041|B2|Baseline|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
637362|NCT00431041|B1|Baseline|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
637363|NCT00431041|P2|Participant Flow|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
637364|NCT00431041|P1|Participant Flow|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
637367|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
637368|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
637369|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
637370|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
637371|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
637372|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
637373|NCT00431041|E2|Reported Event|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
637374|NCT00431041|E1|Reported Event|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
637375|NCT00430950|B3|Baseline|Total|Total of all reporting groups
637376|NCT00430950|B2|Baseline|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
637377|NCT00430950|B1|Baseline|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
637378|NCT00430950|P2|Participant Flow|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
637379|NCT00430950|P1|Participant Flow|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
637380|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
637381|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
637382|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
637383|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
637384|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
637385|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
637386|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
637387|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
637388|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
637389|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
637390|NCT00430937|B3|Baseline|Total|Total of all reporting groups
637391|NCT00430937|B2|Baseline|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
637392|NCT00430937|B1|Baseline|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
637393|NCT00430937|P2|Participant Flow|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
637394|NCT00430937|P1|Participant Flow|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
637395|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
637396|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
637397|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
637398|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
637399|NCT00430937|E2|Reported Event|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
637400|NCT00430937|E1|Reported Event|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
637401|NCT00430781|B4|Baseline|Total|Total of all reporting groups
637402|NCT00430781|B3|Baseline|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
637403|NCT00430781|B2|Baseline|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
637404|NCT00430781|B1|Baseline|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
637405|NCT00430781|P3|Participant Flow|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
637406|NCT00430781|P2|Participant Flow|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
637407|NCT00430781|P1|Participant Flow|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
637408|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
637409|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
637410|NCT00430781|O3|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
637411|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
637412|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
637413|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
637414|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
637415|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
637416|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
649795|NCT00402987|O3|Outcome|Placebo|
637425|NCT00430781|O1|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
637426|NCT00430781|E3|Reported Event|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
637427|NCT00430781|E2|Reported Event|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
637428|NCT00430781|E1|Reported Event|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
637429|NCT00430768|B4|Baseline|Total|Total of all reporting groups
637430|NCT00430768|B3|Baseline|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
637431|NCT00430768|B2|Baseline|Group 2 Middle Dose|"2.1 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
637432|NCT00430768|B1|Baseline|Group 1 Low Dose|"6.9 x10e12 vector genomes~Group 1 receives rAAV1-CB-hAAT 6.9 x1012 vg (vector genomes), e"
637433|NCT00430768|P3|Participant Flow|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
637434|NCT00430768|P2|Participant Flow|Group 2 Middle Dose|"2.1 x 10e13 vector genomes; 2.2 x 10e13 vector genomes~Group 2, 1 subject received rAAV1-CB-hAAT 2.1 x10e13 vg; 202 and 203 received rAAV1-CB-hAAT 2.2 x10e13 vg"
637435|NCT00430768|P1|Participant Flow|Group 1 Low Dose|"6.9 x10e12 vector genomes (vg)~Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg."
637436|NCT00430768|O6|Outcome|303 (High Dose)|Subject 303 M-specific AAT Level
637437|NCT00430768|O5|Outcome|302 (High Dose)|Subject 302 M-specific AAT Level
637438|NCT00430768|O4|Outcome|301 (High Dose)|Subject 301M-specific AAT Level
637439|NCT00430768|O3|Outcome|203 (Medium Dose)|Subject 203 M-specific AAT Level
637440|NCT00430768|O2|Outcome|202 (Medium Dose)|Subject 202 M-specific AAT Level
637441|NCT00430768|O1|Outcome|201 (Medium Dose)|Subject 201 M-specific AAT Level
637442|NCT00430768|O3|Outcome|Group 3 High Dose|
637443|NCT00430768|O2|Outcome|Group 2 Middle Dose|
637444|NCT00430768|O1|Outcome|Group 1 Low Dose|
637445|NCT00430768|E3|Reported Event|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
637446|NCT00430768|E2|Reported Event|Group 2 Middle Dose|"2.2 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg"
637447|NCT00430768|E1|Reported Event|Group 1 Low Dose|"6.9 x10e12 vector genomes~e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes)"
637448|NCT00430755|B1|Baseline|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
637449|NCT00430755|P1|Participant Flow|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
637450|NCT00430755|O1|Outcome|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
637451|NCT00430755|E1|Reported Event|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
637452|NCT00430716|B4|Baseline|Total|Total of all reporting groups
637453|NCT00430716|B3|Baseline|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637454|NCT00430716|B2|Baseline|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637455|NCT00430716|B1|Baseline|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637456|NCT00430716|P3|Participant Flow|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637457|NCT00430716|P2|Participant Flow|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637458|NCT00430716|P1|Participant Flow|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637459|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637460|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637461|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637462|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637463|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637464|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637465|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637466|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637467|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637468|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637469|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637470|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637471|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637472|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637473|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637474|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637475|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637476|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637477|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637478|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637479|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637480|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637481|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637482|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637483|NCT00430716|E3|Reported Event|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
637484|NCT00430716|E2|Reported Event|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637485|NCT00430716|E1|Reported Event|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
637486|NCT00430677|B4|Baseline|Total|Total of all reporting groups
637487|NCT00430677|B3|Baseline|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637488|NCT00430677|B2|Baseline|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637489|NCT00430677|B1|Baseline|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637490|NCT00430677|P3|Participant Flow|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637491|NCT00430677|P2|Participant Flow|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
638190|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
637492|NCT00430677|P1|Participant Flow|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637493|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637494|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637495|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637496|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637497|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637498|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637499|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637500|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637501|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637502|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637503|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
637504|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) Short-term period: by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
637505|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
637506|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
637530|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
649796|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
637507|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
637508|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
637509|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
637510|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637511|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637512|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637513|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637514|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637515|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637516|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637517|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637518|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637519|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637520|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637521|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637522|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637523|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637524|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637525|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637526|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637527|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637528|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637529|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
649797|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
637531|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637532|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637533|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637534|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637535|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637536|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637537|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637538|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637539|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637540|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637541|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637542|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637543|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637544|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637545|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637546|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637547|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637548|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637549|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637550|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637551|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637552|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637553|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637554|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637555|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637920|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637556|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637557|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637558|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637559|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637560|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637561|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637562|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637563|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637564|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637565|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637566|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637567|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637568|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637569|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637570|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637571|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637572|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637573|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637574|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637575|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637576|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637577|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637578|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637579|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637580|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637921|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637581|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637582|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637583|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637584|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637585|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637586|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637587|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637588|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637589|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637590|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637591|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637592|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637593|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637594|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637595|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637596|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637597|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637598|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637599|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637600|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637601|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637602|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637603|NCT00430677|O3|Outcome|Placebo|Placebo (dextrose 5% in water) or normal saline by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637604|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycofenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
637605|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
649798|NCT00402987|O4|Outcome|Placebo|
637606|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637607|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637608|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
637609|NCT00430677|E3|Reported Event|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
637610|NCT00430677|E2|Reported Event|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: Participants received abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent.
637611|NCT00430677|E1|Reported Event|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: In the double-blind period, participants received abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57. In the open-label period, participants received abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
637612|NCT00430638|B3|Baseline|Total|Total of all reporting groups
637613|NCT00430638|B2|Baseline|Placebo Group|Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment.
637614|NCT00430638|B1|Baseline|Olmesartan Group|Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12).
637615|NCT00430638|P2|Participant Flow|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
637616|NCT00430638|P1|Participant Flow|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
637617|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
637618|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
637619|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
637620|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
637621|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
637622|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
637623|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|145 females participants were analyzed.
637624|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
637625|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesartan medoxomil tablets + hydrochlorothiazide tablets, if necessary, once daily for the duration of the 12-week active treatment period.
637626|NCT00430638|O1|Outcome|Placebo Group|Patient received placebo tablets throughout the 12-week active treatment period.
637627|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
637628|NCT00430638|O1|Outcome|Placebo|Patient received placebo tablets.
637629|NCT00430638|E2|Reported Event|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
637630|NCT00430638|E1|Reported Event|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
637631|NCT00430625|B3|Baseline|Total|Total of all reporting groups
637632|NCT00430625|B2|Baseline|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637633|NCT00430625|B1|Baseline|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637634|NCT00430625|P2|Participant Flow|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637635|NCT00430625|P1|Participant Flow|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637636|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637637|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637638|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
638191|NCT00428974|O1|Outcome|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
637639|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637640|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637641|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637642|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637643|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637644|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637645|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637646|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637647|NCT00430625|O1|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637648|NCT00430625|E2|Reported Event|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637649|NCT00430625|E1|Reported Event|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
637650|NCT00430573|B1|Baseline|Overall Study Characteristics|All participants who consented to be in the study
637651|NCT00430573|P1|Participant Flow|All Randomized Participants|The blind was never broken for the study drug, therefore, results can only be presented aggregated for all randomized participants.
637652|NCT00430573|O1|Outcome|Randomized Participants That Completed Baseline ASI|8 of the 10 randomized participants completed the baseline ASI evaluation.
637653|NCT00430573|O1|Outcome|All Randomized Participants|10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants.
637654|NCT00430573|E1|Reported Event|All Randomized Participants|10 participants were randomized and 5 dropped out before taking study drug. The blind was never broken for the study drug, Therefore, results can only be presented aggregated for all randomized participants.
637655|NCT00430508|B5|Baseline|Total|Total of all reporting groups
637656|NCT00430508|B4|Baseline|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
637657|NCT00430508|B3|Baseline|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
637658|NCT00430508|B2|Baseline|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
637659|NCT00430508|B1|Baseline|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
637660|NCT00430508|P4|Participant Flow|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
637661|NCT00430508|P3|Participant Flow|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
637662|NCT00430508|P2|Participant Flow|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
637663|NCT00430508|P1|Participant Flow|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
637664|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637665|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637666|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637667|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637668|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637669|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637670|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637671|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637672|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637673|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637674|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637675|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637676|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637677|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637678|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637679|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637680|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637681|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637682|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637683|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637684|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637685|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637686|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637687|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637688|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637689|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637690|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637691|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637692|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637693|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
637694|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637695|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
637696|NCT00430495|B5|Baseline|Total|Total of all reporting groups
637697|NCT00430495|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637698|NCT00430495|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637699|NCT00430495|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637700|NCT00430495|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637701|NCT00430495|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637702|NCT00430495|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637703|NCT00430495|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637704|NCT00430495|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637705|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637706|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637707|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637708|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637709|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637710|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637711|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637712|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637713|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637714|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637715|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637716|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637717|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637718|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637719|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637720|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637721|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637722|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637723|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637724|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637725|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637726|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637727|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637728|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637729|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637730|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637731|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637732|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637733|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637734|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637735|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637736|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637737|NCT00430495|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
637738|NCT00430495|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
637739|NCT00430495|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
637740|NCT00430495|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
637741|NCT00430352|B1|Baseline|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637742|NCT00430352|P1|Participant Flow|Rituximab 375 Milligrams Per Square Meter (mg/m^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
637743|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637744|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637745|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637746|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637747|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637748|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637985|NCT00429663|B2|Baseline|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
637749|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637750|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637751|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637752|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637753|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637754|NCT00430352|E1|Reported Event|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
637755|NCT00430300|B5|Baseline|Total|Total of all reporting groups
637756|NCT00430300|B4|Baseline|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637757|NCT00430300|B3|Baseline|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637758|NCT00430300|B2|Baseline|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637759|NCT00430300|B1|Baseline|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637760|NCT00430300|P4|Participant Flow|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637761|NCT00430300|P3|Participant Flow|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637762|NCT00430300|P2|Participant Flow|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637763|NCT00430300|P1|Participant Flow|UK-432,097 150 Mcg|UK-432,097 150 microgram (mcg) capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide metered dose inhaler (MDI) 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637764|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637765|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637766|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637767|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637768|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637986|NCT00429663|B1|Baseline|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
649799|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
637769|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637770|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637771|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637772|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637773|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637774|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637775|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637776|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637777|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637778|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637779|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637780|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637781|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637782|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637783|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637784|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637785|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
649800|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
637786|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637787|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637788|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637789|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637790|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637791|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637792|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637793|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637794|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637795|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637796|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637797|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637798|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637799|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637800|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637801|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637802|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
649801|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
637803|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637804|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637805|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637806|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637807|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637808|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637809|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637810|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637811|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637812|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637813|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637814|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637815|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637816|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637817|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637818|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637819|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
649802|NCT00402987|O3|Outcome|Placebo|
637820|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637821|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637822|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637823|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637824|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637825|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637826|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637827|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637828|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637829|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637830|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637831|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637832|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637833|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637834|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637835|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637836|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
649803|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
637837|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637838|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637839|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637840|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637841|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637842|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637843|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637844|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637845|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637846|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637847|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637848|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637849|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637850|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637851|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637852|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637853|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
649804|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
637854|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637855|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637856|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637857|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637858|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637859|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637860|NCT00430300|E4|Reported Event|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637861|NCT00430300|E3|Reported Event|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637862|NCT00430300|E2|Reported Event|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637863|NCT00430300|E1|Reported Event|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
637864|NCT00430248|B4|Baseline|Total|Total of all reporting groups
637865|NCT00430248|B3|Baseline|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637866|NCT00430248|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637867|NCT00430248|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637868|NCT00430248|P3|Participant Flow|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637869|NCT00430248|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637870|NCT00430248|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637871|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637872|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637873|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637874|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637875|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637876|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637877|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637878|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637879|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637987|NCT00429663|P2|Participant Flow|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
637880|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637881|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637882|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637883|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637884|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637885|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637886|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637887|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637888|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637889|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637890|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637891|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637892|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637893|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637894|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637895|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637896|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637897|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637898|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637899|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637900|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637901|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637902|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637903|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637904|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637905|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637906|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637907|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637908|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637909|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637910|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637911|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637912|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637913|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637914|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637915|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637916|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637917|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637918|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637919|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
649805|NCT00402987|O4|Outcome|Placebo|
637922|NCT00430248|E3|Reported Event|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
637923|NCT00430248|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
637924|NCT00430248|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
637925|NCT00430092|B4|Baseline|Total|Total of all reporting groups
637926|NCT00430092|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
637927|NCT00430092|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
637928|NCT00430092|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
637929|NCT00430092|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
637930|NCT00430092|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
637931|NCT00430092|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
637932|NCT00430092|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
637933|NCT00430092|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
637934|NCT00430092|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
637935|NCT00430027|B1|Baseline|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
637936|NCT00430027|P1|Participant Flow|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
637937|NCT00430027|O1|Outcome|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
637938|NCT00430027|E1|Reported Event|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
637939|NCT00429949|B1|Baseline|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
637940|NCT00429949|P1|Participant Flow|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
637941|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
637942|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
637943|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
637944|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
637945|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
637946|NCT00429949|O2|Outcome|Dasatinib 100 mg BID|In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
637947|NCT00429949|O1|Outcome|Dasatinib 70 mg BID|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
637948|NCT00429949|E1|Reported Event|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
637949|NCT00429923|B4|Baseline|Total|Total of all reporting groups
637950|NCT00429923|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
637951|NCT00429923|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
637952|NCT00429923|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
637953|NCT00429923|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
637954|NCT00429923|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
637955|NCT00429923|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
637988|NCT00429663|P1|Participant Flow|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
637956|NCT00429923|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
637957|NCT00429923|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
637958|NCT00429923|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
637959|NCT00429793|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637960|NCT00429793|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637961|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637962|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637963|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637964|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637965|NCT00429793|O5|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
637966|NCT00429793|O4|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
637967|NCT00429793|O3|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
637968|NCT00429793|O2|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
637969|NCT00429793|O1|Outcome|Grade 1 (CTCAE v3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
637970|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637971|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637972|NCT00429793|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
637973|NCT00429702|B3|Baseline|Total|Total of all reporting groups
637974|NCT00429702|B2|Baseline|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
637975|NCT00429702|B1|Baseline|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
637976|NCT00429702|P2|Participant Flow|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
637977|NCT00429702|P1|Participant Flow|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
637978|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
637979|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
637980|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
637981|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
637982|NCT00429702|E2|Reported Event|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
637983|NCT00429702|E1|Reported Event|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
637984|NCT00429663|B3|Baseline|Total|Total of all reporting groups
638192|NCT00428974|E4|Reported Event|Placebo|Oral tablets given every 12 hours for 12 weeks
637989|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
637990|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
637991|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
637992|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
637993|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
637994|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
637995|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
637996|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
637997|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
637998|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
637999|NCT00429663|E2|Reported Event|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
638000|NCT00429663|E1|Reported Event|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
638001|NCT00429572|B1|Baseline|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638002|NCT00429572|P1|Participant Flow|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638003|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638004|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638005|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638006|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638007|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638008|NCT00429572|E1|Reported Event|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
638009|NCT00429507|B1|Baseline|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
638010|NCT00429507|P1|Participant Flow|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
638011|NCT00429507|O1|Outcome|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
638012|NCT00429507|E1|Reported Event|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
638013|NCT00429494|B1|Baseline|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
638014|NCT00429494|P1|Participant Flow|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
638015|NCT00429494|O1|Outcome|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
638016|NCT00429494|E1|Reported Event|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
638017|NCT00429416|B1|Baseline|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
638018|NCT00429416|P1|Participant Flow|LLME to Decrease GVHD Following HSC T|"To determine if an experimental agent, L-leucyl-L-leucine Methyl Ester (LLME), can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).~Treatment Outline:~Day -6: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV Day -5: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -4: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -3: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -2: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -1: Rest day Day 0: CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells Day 1: Infusion of LLME treated donor CD34 – cells"
638019|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
638020|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
638021|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
638022|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
638023|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
638024|NCT00429416|E1|Reported Event|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
638025|NCT00429403|B3|Baseline|Total|Total of all reporting groups
638026|NCT00429403|B2|Baseline|No Goserelin|
638027|NCT00429403|B1|Baseline|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
638028|NCT00429403|P2|Participant Flow|No Goserelin|
638029|NCT00429403|P1|Participant Flow|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
638030|NCT00429403|O2|Outcome|No Goserelin|
638031|NCT00429403|O1|Outcome|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
638032|NCT00429403|E2|Reported Event|No Goserelin|
638033|NCT00429403|E1|Reported Event|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
638034|NCT00429364|B3|Baseline|Total|Total of all reporting groups
638035|NCT00429364|B2|Baseline|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638036|NCT00429364|B1|Baseline|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638037|NCT00429364|P2|Participant Flow|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638038|NCT00429364|P1|Participant Flow|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638039|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638040|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638041|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638042|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638043|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638044|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638045|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638046|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638047|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638048|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638049|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638050|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638051|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638052|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638053|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638054|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638055|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638193|NCT00428974|E3|Reported Event|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
638056|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638057|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638058|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638059|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638060|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638061|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638062|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638063|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638064|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638065|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638066|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638067|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638068|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638069|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638070|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638071|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638072|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638073|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638074|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638075|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638076|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638077|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638078|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638079|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638080|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638081|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638082|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638083|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638084|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638085|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638086|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638194|NCT00428974|E2|Reported Event|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
638087|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638088|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638089|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638090|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638091|NCT00429364|E2|Reported Event|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
638092|NCT00429364|E1|Reported Event|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
638093|NCT00429299|B4|Baseline|Total|Total of all reporting groups
638094|NCT00429299|B3|Baseline|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
638095|NCT00429299|B2|Baseline|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
638096|NCT00429299|B1|Baseline|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638097|NCT00429299|P3|Participant Flow|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
638098|NCT00429299|P2|Participant Flow|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
638099|NCT00429299|P1|Participant Flow|Chemotherapy (CT) Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638100|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638140|NCT00429182|B1|Baseline|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
638195|NCT00428974|E1|Reported Event|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
638101|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638102|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638103|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638104|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638105|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638106|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638107|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638108|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638109|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638110|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638185|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
638111|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638112|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638113|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638114|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638115|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638116|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638117|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638118|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638119|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638120|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638196|NCT00428948|B3|Baseline|Total|Total of all reporting groups
638121|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
638122|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
638123|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638124|NCT00429299|E3|Reported Event|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
638125|NCT00429299|E2|Reported Event|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
638126|NCT00429299|E1|Reported Event|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
638127|NCT00429273|B4|Baseline|Total|Total of all reporting groups
638128|NCT00429273|B3|Baseline|Group 3: Guan-Guan+DMPH (Comb)|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
638129|NCT00429273|B2|Baseline|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
638130|NCT00429273|B1|Baseline|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine +Placebo
638131|NCT00429273|P3|Participant Flow|Group 3: Guan-Guan+DMPH|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
638132|NCT00429273|P2|Participant Flow|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
638133|NCT00429273|P1|Participant Flow|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
638134|NCT00429273|O3|Outcome|Estimated Difference Between Placebo and Combo|Contrasts based on all observations of patients treated with combo and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the guan-combo arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
638135|NCT00429273|O2|Outcome|Estimated Difference Between DMPH and Placebo|Contrasts based on all observations of patients treated with dmph and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the placebo-guan arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
638136|NCT00429273|O1|Outcome|Estimated Difference Between Guan and Placebo|Contrasts based on all observations of patients treated with guam and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for guan are based on the guan-guan arm both at 4 weeks and 8 weeks, and the guan-combo arm at 4 weeks only. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
638137|NCT00429273|E3|Reported Event|Group 3: Guan-Guan+DMPH|week 1-4: Guanfacine week 5-8: Guanfacine+DMPH (comb)
638138|NCT00429273|E2|Reported Event|Group 2: Placebo-Placebo+DMPH|week 1-4: Placebo week 5-8: Placebo+DMPH
638139|NCT00429273|E1|Reported Event|Group 1: Guan-Guan+Placebo|week 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
649806|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
638141|NCT00429182|P1|Participant Flow|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target area under the curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
638142|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
638143|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
638144|NCT00429182|E1|Reported Event|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
638145|NCT00429169|B3|Baseline|Total|Total of all reporting groups
638146|NCT00429169|B2|Baseline|Bupropion|Participants will receive bupropion for 8 weeks
638147|NCT00429169|B1|Baseline|Paroxetine|Participants will receive paroxetine for 8 weeks
638148|NCT00429169|P2|Participant Flow|Bupropion|Participants will receive bupropion for 8 weeks
638149|NCT00429169|P1|Participant Flow|Paroxetine|Participants will receive paroxetine for 8 weeks
638150|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
638151|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
638152|NCT00429169|O2|Outcome|Bupropion|Bupropion acute treatment for 8 weeks.
638153|NCT00429169|O1|Outcome|Paroxetine|Paroxetine acute treatment for 8 weeks.
638154|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
638155|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
638156|NCT00429169|E2|Reported Event|Bupropion|Participants will receive bupropion for 8 weeks
638157|NCT00429169|E1|Reported Event|Paroxetine|Participants will receive paroxetine for 8 weeks
638158|NCT00429143|B1|Baseline|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638159|NCT00429143|P1|Participant Flow|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638160|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638161|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638162|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638163|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638164|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638165|NCT00429143|E1|Reported Event|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
638166|NCT00429104|B1|Baseline|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
638167|NCT00429104|P1|Participant Flow|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
638168|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
638169|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
638170|NCT00429104|E1|Reported Event|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
638171|NCT00429026|B1|Baseline|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
638172|NCT00429026|P1|Participant Flow|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
638173|NCT00429026|O1|Outcome|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
638174|NCT00429026|E1|Reported Event|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
638175|NCT00428974|B5|Baseline|Total|Total of all reporting groups
638176|NCT00428974|B4|Baseline|Placebo|Oral tablets given every 12 hours for 12 weeks
638177|NCT00428974|B3|Baseline|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
638178|NCT00428974|B2|Baseline|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
638179|NCT00428974|B1|Baseline|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
638180|NCT00428974|P4|Participant Flow|Placebo|Oral tablets given every 12 hours for 12 weeks
638181|NCT00428974|P3|Participant Flow|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
638182|NCT00428974|P2|Participant Flow|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
638183|NCT00428974|P1|Participant Flow|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
638184|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
638197|NCT00428948|B2|Baseline|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638198|NCT00428948|B1|Baseline|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638199|NCT00428948|P2|Participant Flow|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638200|NCT00428948|P1|Participant Flow|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638201|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638202|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638203|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638204|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638205|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638206|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638207|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638208|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638209|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638210|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638211|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638212|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638213|NCT00428948|O2|Outcome|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638214|NCT00428948|O1|Outcome|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638215|NCT00428948|E2|Reported Event|Placebo|Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
638216|NCT00428948|E1|Reported Event|Tolvaptan|Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
638217|NCT00428922|B1|Baseline|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
638218|NCT00428922|P1|Participant Flow|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
638219|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
638220|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
638221|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
638222|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
638223|NCT00428922|E1|Reported Event|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
638224|NCT00428844|B4|Baseline|Total|Total of all reporting groups
638225|NCT00428844|B3|Baseline|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
638226|NCT00428844|B2|Baseline|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638227|NCT00428844|B1|Baseline|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638228|NCT00428844|P3|Participant Flow|Comparator|Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
638229|NCT00428844|P2|Participant Flow|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
638230|NCT00428844|P1|Participant Flow|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
638231|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638232|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638233|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638234|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638235|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
638236|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638237|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
649807|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
638238|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
638239|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638240|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638241|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
638242|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638243|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638244|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
638245|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638246|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638247|NCT00428844|E3|Reported Event|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
638248|NCT00428844|E2|Reported Event|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638249|NCT00428844|E1|Reported Event|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
638250|NCT00428792|B3|Baseline|Total|Total of all reporting groups
638251|NCT00428792|B2|Baseline|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638252|NCT00428792|B1|Baseline|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638253|NCT00428792|P2|Participant Flow|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638254|NCT00428792|P1|Participant Flow|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638255|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638256|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638257|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638258|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638259|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638322|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638323|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638324|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638260|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638261|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638262|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638263|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638264|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638265|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638266|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638267|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638268|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638269|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638270|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638271|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638272|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638273|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638274|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638295|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638275|NCT00428792|E2|Reported Event|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
638276|NCT00428792|E1|Reported Event|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
638277|NCT00428610|B4|Baseline|Total|Total of all reporting groups
638278|NCT00428610|B3|Baseline|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638279|NCT00428610|B2|Baseline|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638280|NCT00428610|B1|Baseline|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638281|NCT00428610|P3|Participant Flow|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638282|NCT00428610|P2|Participant Flow|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638283|NCT00428610|P1|Participant Flow|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638284|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638285|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638286|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638287|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638288|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638289|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638290|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638291|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638292|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638293|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638294|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638296|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638297|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638298|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638299|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638300|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638301|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638302|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638303|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638304|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638305|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638306|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638307|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638308|NCT00428610|O3|Outcome|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638309|NCT00428610|O2|Outcome|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638310|NCT00428610|O1|Outcome|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638311|NCT00428610|E3|Reported Event|Albumin-Tailored Dose|The dose of LY573636 administered in each infusion was based on participant's height, weight, gender, pre-cycle albumin level, and cycle number to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour*micrograms/milliliter (h*μg/mL), administered over approximately 2 hours on Day 1 of a 28-day treatment cycle.
638312|NCT00428610|E2|Reported Event|Target Cmax 360 μg/mL|Loading dose of LY573636, targeting a Cmax of 360 μg/mL, followed by a lower chronic dose (which was 90% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638313|NCT00428610|E1|Reported Event|Target Cmax 420 µg/mL|Loading dose of LY573636, targeting a maximum concentration (Cmax) of 420 micrograms/milliliter (μg/mL), followed by a lower chronic dose (which was 75% of the loading dose) in subsequent cycles, administered as an intravenous infusion given over approximately 2 hours, on Day 1 of a 21-day treatment cycle.
638314|NCT00428597|B3|Baseline|Total|Total of all reporting groups
638315|NCT00428597|B2|Baseline|Placebo|Matching placebo.
638316|NCT00428597|B1|Baseline|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638317|NCT00428597|P2|Participant Flow|Placebo|Matching placebo.
638318|NCT00428597|P1|Participant Flow|Sunitinib|Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
638319|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638320|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638321|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638326|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638327|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638328|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638329|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638330|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638331|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638332|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638333|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638334|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638335|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638336|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638337|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638338|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638339|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638340|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638341|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638342|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638343|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638344|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638345|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638346|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638347|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638348|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638349|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638350|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638351|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638352|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638353|NCT00428597|O2|Outcome|Placebo|Matching placebo.
638354|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638355|NCT00428597|E2|Reported Event|Placebo|Matching placebo.
638356|NCT00428597|E1|Reported Event|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
638357|NCT00428584|B3|Baseline|Total|Total of all reporting groups
638358|NCT00428584|B2|Baseline|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638359|NCT00428584|B1|Baseline|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
638360|NCT00428584|P2|Participant Flow|Betaseron|
638361|NCT00428584|P1|Participant Flow|New Formulation of Rebif|The new formulation of rebif is not approved and under investigation in the US
638362|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
638363|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
638364|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
638365|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
638366|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
638367|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
638368|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
638369|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
638370|NCT00428584|O2|Outcome|Betaseron to New Formulation of Rebif|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638371|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, new formualation of rebif- 44 mcg, subcutaneous injection, three times a week
638372|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638373|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
638374|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638375|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
638376|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638377|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
638378|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638379|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
638380|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638381|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
638382|NCT00428584|E2|Reported Event|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
638383|NCT00428584|E1|Reported Event|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
638384|NCT00428441|B1|Baseline|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
638385|NCT00428441|P1|Participant Flow|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
638386|NCT00428441|O1|Outcome|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
638387|NCT00428441|E1|Reported Event|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
638388|NCT00428389|B3|Baseline|Total|Total of all reporting groups
638389|NCT00428389|B2|Baseline|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638390|NCT00428389|B1|Baseline|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638391|NCT00428389|P2|Participant Flow|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638392|NCT00428389|P1|Participant Flow|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638393|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638394|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638395|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638396|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638397|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638648|NCT00427934|B4|Baseline|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638398|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638399|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638400|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638401|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638402|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638403|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638404|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638405|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638406|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638407|NCT00428389|E2|Reported Event|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638408|NCT00428389|E1|Reported Event|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
638409|NCT00428298|B3|Baseline|Total|Total of all reporting groups
638410|NCT00428298|B2|Baseline|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
638411|NCT00428298|B1|Baseline|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
638412|NCT00428298|P2|Participant Flow|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
638413|NCT00428298|P1|Participant Flow|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
638414|NCT00428298|O2|Outcome|Inactive Treatment Group - Placebo|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
638415|NCT00428298|O1|Outcome|Active Treatment Group - Valcyclovir|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
638416|NCT00428298|O2|Outcome|Inactive Treatment Group - Placebo|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
638417|NCT00428298|O1|Outcome|Active Treatment Group - Valcyclovir|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
638418|NCT00428298|O2|Outcome|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
638419|NCT00428298|O1|Outcome|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
638420|NCT00428298|E2|Reported Event|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
638421|NCT00428298|E1|Reported Event|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
638422|NCT00428246|B4|Baseline|Total|Total of all reporting groups
638423|NCT00428246|B3|Baseline|3|Placebo
638424|NCT00428246|B2|Baseline|2|2 mcg paricalcitol
638425|NCT00428246|B1|Baseline|1|1 mcg paricalcitol
638426|NCT00428246|P3|Participant Flow|3|Placebo
638427|NCT00428246|P2|Participant Flow|2|2 mcg paricalcitol
638428|NCT00428246|P1|Participant Flow|1|1 mcg paricalcitol
638429|NCT00428246|O3|Outcome|3|Placebo
638430|NCT00428246|O2|Outcome|2|2 mcg paricalcitol
638431|NCT00428246|O1|Outcome|1|1 mcg paricalcitol
638432|NCT00428246|E3|Reported Event|3|Placebo
638433|NCT00428246|E2|Reported Event|2|2 mcg paricalcitol
638434|NCT00428246|E1|Reported Event|1|1 mcg paricalcitol
638435|NCT00428220|B1|Baseline|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
638436|NCT00428220|P1|Participant Flow|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
638437|NCT00428220|O11|Outcome|Sunitinib 11|Parent Study: A6181170
638438|NCT00428220|O10|Outcome|Sunitinib 10|Parent Study: A6181126
638439|NCT00428220|O9|Outcome|Sunitinib 9|Parent Study: A6181120
638440|NCT00428220|O8|Outcome|Sunitinib 8|Parent Study: A6181113
638441|NCT00428220|O7|Outcome|Sunitinib 7|Parent Study: A6181112
638442|NCT00428220|O6|Outcome|Sunitinib 6|Parent Study: A6181111
638443|NCT00428220|O5|Outcome|Sunitinib 5|Parent Study: A6181110
638444|NCT00428220|O4|Outcome|Sunitinib 4|Parent Study: A6181107
638445|NCT00428220|O3|Outcome|Sunitinib 3|Parent Study: A6181094
638446|NCT00428220|O2|Outcome|Sunitinib 2|Parent Study: A6181087
638447|NCT00428220|O1|Outcome|Sunitinib 1|Parent Study: A6181078
638448|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
638449|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
638450|NCT00428220|E1|Reported Event|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
638492|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638451|NCT00428207|B1|Baseline|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.~insulin pump :"
638452|NCT00428207|P2|Participant Flow|Insulin Aspart|"Subjects will be randomly assigned to one of the two insulins (insulin Aspart) by the statistician working in the study via random number generation.~First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.~After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.~The sequence of interventions may be reversed due to random assignment of treatment."
638453|NCT00428207|P1|Participant Flow|Insulin Lispro|"Subjects will be randomly assigned to one of the two insulins (insulin Lispro) by the statistician working in the study via random number generation.~First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.~After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.~The sequence of interventions may be reversed due to random assignment of treatment."
638454|NCT00428207|O1|Outcome|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.~insulin pump :"
638455|NCT00428207|O2|Outcome|Insulin Lispro Versus Insulin Aspart|"Insulin lispro will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Dose will be adjusted as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Aspart).~Insulin Lispro versus Insulin Aspart: Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients."
638456|NCT00428207|O1|Outcome|Insulin Aspart Versus Insulin Lispro|"Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Lispro).~Insulin Aspart versus Insulin Lispro: Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients."
638457|NCT00428207|E1|Reported Event|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization."
638458|NCT00428116|B3|Baseline|Total|Total of all reporting groups
638459|NCT00428116|B2|Baseline|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
638460|NCT00428116|B1|Baseline|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
638461|NCT00428116|P2|Participant Flow|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
638462|NCT00428116|P1|Participant Flow|Continued HAART|After 24 months of HAART, infants were continued on HAART.
638463|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
638464|NCT00428116|O1|Outcome|Continue HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
638465|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
638466|NCT00428116|O1|Outcome|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
638467|NCT00428116|E2|Reported Event|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
638468|NCT00428116|E1|Reported Event|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
638469|NCT00428090|B5|Baseline|Total|Total of all reporting groups
638470|NCT00428090|B4|Baseline|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638600|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
638471|NCT00428090|B3|Baseline|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638472|NCT00428090|B2|Baseline|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638473|NCT00428090|B1|Baseline|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638474|NCT00428090|P4|Participant Flow|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638475|NCT00428090|P3|Participant Flow|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638476|NCT00428090|P2|Participant Flow|RSG XR 2 mg|Par. in this arm received rosiglitazone extended release (RSGXR) 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638477|NCT00428090|P1|Participant Flow|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638478|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638479|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638480|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638481|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638482|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638483|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638484|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638485|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638486|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638487|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638488|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638489|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638490|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638491|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
639878|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
638493|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638494|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638495|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638496|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638497|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638498|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638499|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638500|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638501|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638502|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638503|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638504|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638505|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638506|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638507|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638508|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638509|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638510|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638511|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638512|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638513|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638601|NCT00427999|E2|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)|Extension follow-up
639917|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
638514|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638515|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638516|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638517|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638518|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4Wof treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638519|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638520|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638521|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638522|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638523|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638524|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638525|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638526|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638527|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638528|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638529|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638530|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638531|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638532|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638533|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638534|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638638|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638535|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638536|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638537|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638538|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638539|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638540|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638541|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638542|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638543|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638544|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638545|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638546|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638547|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638548|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638549|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638550|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638551|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638552|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638553|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638554|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638555|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638639|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638556|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638557|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638558|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638559|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638560|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638561|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638562|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638563|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638564|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638565|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638566|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638567|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638568|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638569|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638570|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638571|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638572|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638573|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638574|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638575|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638576|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638577|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638578|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638579|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638580|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638581|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638582|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638583|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638584|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638585|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638586|NCT00428090|E4|Reported Event|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638587|NCT00428090|E3|Reported Event|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
638588|NCT00428090|E2|Reported Event|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638589|NCT00428090|E1|Reported Event|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
638590|NCT00428077|B1|Baseline|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
638591|NCT00428077|P1|Participant Flow|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
638592|NCT00428077|O1|Outcome|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients with Philadelphia Chromosome (Ph+) or Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL),positive Chronic Myeloid Leukemia(CML), in cytogenetic remission, with minimal residual disease.
638593|NCT00428077|E1|Reported Event|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
638594|NCT00427999|B1|Baseline|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
638595|NCT00427999|P1|Participant Flow|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
638596|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
638597|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
638598|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
638599|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
638602|NCT00427999|E1|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)
638603|NCT00427973|B1|Baseline|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
638604|NCT00427973|P1|Participant Flow|Singe Arm Open Label Study With AZD2171 at 30 mg Daily.|Patients will receive AZD2171 by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies.
638605|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
638606|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
638607|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
638608|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
638609|NCT00427973|E1|Reported Event|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
638610|NCT00427960|B3|Baseline|Total|Total of all reporting groups
638611|NCT00427960|B2|Baseline|Atorvastatin|atorvastatin 10 mg
638612|NCT00427960|B1|Baseline|Rosuvastatin|rosuvastatin 5 mg
638613|NCT00427960|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg
638614|NCT00427960|P1|Participant Flow|Rosuvastatin|rosuvastatin 5 mg
638615|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638616|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638617|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638618|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638619|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638620|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638621|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638622|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638623|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638624|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638625|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638626|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638627|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638628|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638629|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638630|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638631|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638632|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638633|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638634|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638635|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638636|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
638637|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
638649|NCT00427934|B3|Baseline|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638650|NCT00427934|B2|Baseline|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638651|NCT00427934|B1|Baseline|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638652|NCT00427934|P4|Participant Flow|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638653|NCT00427934|P3|Participant Flow|Maraviroc 300 mg BID (Proof-of-Concept [POC])|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638654|NCT00427934|P2|Participant Flow|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638655|NCT00427934|P1|Participant Flow|Maraviroc 150 mg BID (Pharmacokinetic [PK])|150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
638656|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638657|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638658|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638659|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638660|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638661|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638662|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638663|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638664|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638665|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638666|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638667|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638668|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638669|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638670|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638671|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638672|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638673|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638674|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638675|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638676|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638677|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638678|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638679|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638680|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638681|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638682|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638683|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638684|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638685|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638686|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638687|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638688|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638689|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638690|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638691|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638692|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638693|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638694|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638695|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638696|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638697|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638698|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638699|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638700|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638701|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638702|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638703|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638704|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638705|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638706|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638707|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638708|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638709|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638710|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638711|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638712|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638713|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638714|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638715|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638716|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638717|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638718|NCT00427934|E4|Reported Event|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638719|NCT00427934|E3|Reported Event|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
638720|NCT00427934|E2|Reported Event|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638721|NCT00427934|E1|Reported Event|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
638722|NCT00427921|B1|Baseline|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638723|NCT00427921|P1|Participant Flow|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638724|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638725|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638726|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638727|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638728|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638729|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
639089|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
638730|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638731|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638732|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638733|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638734|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638735|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638736|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638737|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638738|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638739|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638740|NCT00427921|E1|Reported Event|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
638741|NCT00427895|B5|Baseline|Total|Total of all reporting groups
638742|NCT00427895|B4|Baseline|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638743|NCT00427895|B3|Baseline|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638744|NCT00427895|B2|Baseline|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638745|NCT00427895|B1|Baseline|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
638746|NCT00427895|P8|Participant Flow|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
638747|NCT00427895|P7|Participant Flow|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
638748|NCT00427895|P6|Participant Flow|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
638749|NCT00427895|P5|Participant Flow|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
638750|NCT00427895|P4|Participant Flow|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
638751|NCT00427895|P3|Participant Flow|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
638752|NCT00427895|P2|Participant Flow|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
638753|NCT00427895|P1|Participant Flow|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at baseline.
638754|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
638755|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638756|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638757|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
638758|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638759|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1) Year 0.
638760|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1) at Year 0.
638761|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at Year 0.
638869|NCT00427635|B2|Baseline|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638762|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
638763|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638764|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638765|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
638766|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638767|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1).
638768|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1).
638769|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
638770|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
638771|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638772|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638773|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638774|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
638775|NCT00427895|O3|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638776|NCT00427895|O2|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638777|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
638778|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638779|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638780|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638781|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
638782|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638783|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638784|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
638785|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638786|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
638787|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638788|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1).
638789|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
638790|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
638791|NCT00427895|E16|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
638792|NCT00427895|E15|Reported Event|13vPnC, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
638793|NCT00427895|E14|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
638794|NCT00427895|E13|Reported Event|13vPnC/13vPnC, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
640300|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
638795|NCT00427895|E12|Reported Event|23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
638796|NCT00427895|E11|Reported Event|23vPS/23vPS, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
638797|NCT00427895|E10|Reported Event|13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
638798|NCT00427895|E9|Reported Event|13vPnC/23vPS, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
638799|NCT00427895|E8|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
638800|NCT00427895|E7|Reported Event|13vPnC/13vPnC, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
638801|NCT00427895|E6|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
638802|NCT00427895|E5|Reported Event|13vPnC, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
638803|NCT00427895|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
638804|NCT00427895|E3|Reported Event|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
638805|NCT00427895|E2|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
638806|NCT00427895|E1|Reported Event|13vPnC, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 [Vax1]), reported after vaccination.
638807|NCT00427804|B3|Baseline|Total|Total of all reporting groups
638808|NCT00427804|B2|Baseline|Crohn's Disease|Subjects with stable Crohn's disease
638809|NCT00427804|B1|Baseline|Healthy Control|
638810|NCT00427804|P2|Participant Flow|Crohn's Disease|Subjects with stable Crohn's disease
638811|NCT00427804|P1|Participant Flow|Healthy Control|
638812|NCT00427804|O2|Outcome|Crohn's Disease|Subjects with stable Crohn's disease
638813|NCT00427804|O1|Outcome|Healthy Control|
638814|NCT00427804|E2|Reported Event|Crohn's Disease|Subjects with stable Crohn's disease
638815|NCT00427804|E1|Reported Event|Healthy Control|
638816|NCT00427791|B3|Baseline|Total|Total of all reporting groups
638817|NCT00427791|B2|Baseline|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
638818|NCT00427791|B1|Baseline|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
638819|NCT00427791|P2|Participant Flow|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
638820|NCT00427791|P1|Participant Flow|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
638821|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
638822|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
638823|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
638824|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
638825|NCT00427791|E2|Reported Event|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
638826|NCT00427791|E1|Reported Event|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
638827|NCT00427778|B1|Baseline|All Study Participants|All participants who were randomised to a treatment sequence group
638828|NCT00427778|P2|Participant Flow|No Treatment, Then Incontinence Ring|Participants first were assessment while no active treatment was received, for a period of 4 weeks. After a washout period of 2 weeks, they continued evaluation after an incontinence ring was fitted.
638829|NCT00427778|P1|Participant Flow|Incontinence Ring, Then no Treatment|participants first were fitted to an incontinence ring, which they wore for a period of 4 weeks, then it was removed. After a washout period of 2 weeks, they continued evaluation but with no active treatment
638870|NCT00427635|B1|Baseline|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638830|NCT00427778|O2|Outcome|no Treatment|"PVR done at baseline UDS after uroflow. UDS was needed to determine baseline eligibility. We felt that this baseline UDS was representative of the no treatment' UDS and therefore considered as such. Doing a third UDs during the no treatment period per se was deemed unnecessary and subjected patient to redundant testing."
638831|NCT00427778|O1|Outcome|Incontinence Ring Users|PVR done at UDS during uroflow while using ring
638832|NCT00427778|O1|Outcome|Incontinence Ring|While wearing the incontinence ring,w omen were asked to fill out the VAS
638833|NCT00427778|O2|Outcome|Controls|no intervention
638834|NCT00427778|O1|Outcome|Incontinence Ring Users|"Use of incontinence ring~incontinence ring (Milex): Incontinence ring fitted to patient's anatomy (by choosing appropriate size). It is worn continually for the duration of the treatment period.~Intravaginal incontinence ring placed proximally in the posterior vaginal fornix. Knob located at mid-urethra."
638835|NCT00427778|O2|Outcome|no Treatment|All participants underwent UDS at baseline , when not wearing a ring. The flow rate obtained during this part of hte study is considered the 'no treatment' flow rate, irrespective of study arm.
638836|NCT00427778|O1|Outcome|Incontinence Ring|UDS done with ring in place
638837|NCT00427778|O2|Outcome|No Treatment|UDS done without ring. All patients had UDS done without the ring prior to entry into the study. This UDS was considered to reflect the 'no treatment' period, although technically it was done at baseline. A UDS during the 'no treatment' period would have been ideal, but this would have represented an additional UDS testing that likely would not have differed from the baseline testing. All patients needed to have UDS-proven urodynamic stress incontinence as inclusion criteria.
638838|NCT00427778|O1|Outcome|Incontinence Ring|UDS done with ring in situ. UDS was performed while using the ring, towards the end of the 4-week ring use period.
638839|NCT00427778|O2|Outcome|Controls|participants completed the UDI questionnaire at the end of 4 weeks of the 'no treatment' week.
638840|NCT00427778|O1|Outcome|Incontinence Ring|participants completed the UDI questionnaire at the end of 4 weeks of ring use.
638841|NCT00427778|O2|Outcome|Controls|no treatment
638842|NCT00427778|O1|Outcome|Incontinence Ring|Use of incontinence ring
638843|NCT00427778|O2|Outcome|Controls|participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as <50% improvement from baseline.
638844|NCT00427778|O1|Outcome|Incontinence Ring|participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (<50% improvement from baseline)
638845|NCT00427778|E2|Reported Event|No Treatment|no intervention
638846|NCT00427778|E1|Reported Event|Incontinence Ring|"Use of incontinence ring~incontinence ring (Milex): Incontinence ring fitted to patient's anatomy (by choosing appropriate size). It is worn continually for the duration of the treatment period.~Intravaginal incontinence ring placed proximally in the posterior vaginal fornix. Knob located at mid-urethra."
638847|NCT00427765|B1|Baseline|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
638848|NCT00427765|P1|Participant Flow|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
638849|NCT00427765|O1|Outcome|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
638850|NCT00427765|E1|Reported Event|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
638851|NCT00427700|B3|Baseline|Total|Total of all reporting groups
638852|NCT00427700|B2|Baseline|Clomiphene|"Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle"
638853|NCT00427700|B1|Baseline|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle"
638854|NCT00427700|P2|Participant Flow|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
638855|NCT00427700|P1|Participant Flow|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
638856|NCT00427700|O2|Outcome|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
638857|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
638858|NCT00427700|O2|Outcome|Raloxifene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
638859|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
638860|NCT00427700|E2|Reported Event|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle~Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild"
638861|NCT00427700|E1|Reported Event|Clomiphene Citrate|"Use of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle~One woman in the CC group had nausea, headache, and abdominal bloating."
638862|NCT00427661|B1|Baseline|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
638863|NCT00427661|P1|Participant Flow|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
638864|NCT00427661|O1|Outcome|Experimental|Busulfan, Fludarabine, Cyclosporine, MMF
638865|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
638866|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
638867|NCT00427661|E1|Reported Event|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
638868|NCT00427635|B3|Baseline|Total|Total of all reporting groups
638943|NCT00426842|O1|Outcome|No-drug|
649808|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
638871|NCT00427635|P2|Participant Flow|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638872|NCT00427635|P1|Participant Flow|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638873|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638874|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638875|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638876|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638877|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638878|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638879|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638880|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638881|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638882|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638883|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638884|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638885|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638886|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638887|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638888|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638889|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638890|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638891|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638892|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638893|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638894|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638895|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638896|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638897|NCT00427635|E2|Reported Event|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638898|NCT00427635|E1|Reported Event|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
638899|NCT00427557|B1|Baseline|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
638900|NCT00427557|P1|Participant Flow|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
638901|NCT00427557|O1|Outcome|Fludarabine + Melphalan + Umbilical Cord Blood Unit|Fludarabine 30 mg/m^2 given daily for four days. Melphalan 140 mg/m^2 given for one day. Umbilical Cord Blood Unit given on one day.
638902|NCT00427557|E1|Reported Event|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
638944|NCT00426842|E1|Reported Event|All Participants|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
638945|NCT00426764|B1|Baseline|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638903|NCT00427349|B1|Baseline|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
638904|NCT00427349|P1|Participant Flow|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
638905|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
638906|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
638907|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
638908|NCT00427349|E1|Reported Event|MG 706+Octreotide|AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment. Each cycle was defined as 28 days. AMG 706 was started within 7 working days of registration, given on the same day as the octreotide-LAR.
638909|NCT00427336|B1|Baseline|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
638910|NCT00427336|P1|Participant Flow|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
638911|NCT00427336|O1|Outcome|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
638912|NCT00427336|E1|Reported Event|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
638913|NCT00427037|B3|Baseline|Total|Total of all reporting groups
638914|NCT00427037|B2|Baseline|Cholecalciferol|This is vitamin D3 or Cholecalciferol
638915|NCT00427037|B1|Baseline|Placebo|This is a matching placebo
638916|NCT00427037|P2|Participant Flow|Cholecalciferol|This is vitamin D3 or Cholecalciferol
638917|NCT00427037|P1|Participant Flow|Placebo|This is a matching placebo
638918|NCT00427037|O2|Outcome|Cholecalciferol|This is vitamin D3 or Cholecalciferol
638919|NCT00427037|O1|Outcome|Placebo|This is a matching placebo
638920|NCT00427037|O2|Outcome|Cholecalciferol|"D3~Cholecalciferol: 50,000 IU weekly by mouth"
638921|NCT00427037|O1|Outcome|Placebo|"Placebo~Placebo: identical placebo pill orally by mouth"
638922|NCT00427037|E2|Reported Event|Cholecalciferol|This is vitamin D3 or Cholecalciferol
638923|NCT00427037|E1|Reported Event|Placebo|This is a matching placebo
638924|NCT00427011|B1|Baseline|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638925|NCT00427011|P1|Participant Flow|Perampanel|Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638990|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638926|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638927|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638928|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638929|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638930|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638931|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638932|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638933|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638934|NCT00427011|E1|Reported Event|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
638935|NCT00426855|B1|Baseline|Group 1|Bortezomib, Bendamustin, combination chemotherapy in nhl
638936|NCT00426855|P1|Participant Flow|Group 1|Bortezomib, Bendamustine, NHL, combination chemotherapy
638937|NCT00426855|O1|Outcome|Group 1|NHL treated with combination chemotherapy of bendamustin and bortezomib
638938|NCT00426855|E1|Reported Event|Group 1|NHL Patients treated with combination of bendamustine and bortezomib
638939|NCT00426842|B1|Baseline|Arm 1|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
638940|NCT00426842|P1|Participant Flow|All Participants|All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
638941|NCT00426842|O3|Outcome|Midodrine 10 mg|
638942|NCT00426842|O2|Outcome|Midodrine 5 mg|
638946|NCT00426764|P1|Participant Flow|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638947|NCT00426764|O6|Outcome|Best ECOG = 4|Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638948|NCT00426764|O5|Outcome|Best ECOG = 3|Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638949|NCT00426764|O4|Outcome|Best ECOG = 2|Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638950|NCT00426764|O3|Outcome|Best ECOG = 1|Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638951|NCT00426764|O2|Outcome|Best ECOG = 0|Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638952|NCT00426764|O1|Outcome|Missing|Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638953|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638954|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638955|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638956|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638957|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638958|NCT00426764|E1|Reported Event|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
638959|NCT00426751|B3|Baseline|Total|Total of all reporting groups
638960|NCT00426751|B2|Baseline|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638961|NCT00426751|B1|Baseline|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638962|NCT00426751|P2|Participant Flow|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638963|NCT00426751|P1|Participant Flow|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638964|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638965|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638966|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638967|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638968|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638969|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638970|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638971|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638972|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638973|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638974|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638975|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638976|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638977|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638978|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638979|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638980|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638981|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638982|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638983|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638984|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638985|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638986|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638987|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638988|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638989|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
649809|NCT00402987|O3|Outcome|Placebo|
638991|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638992|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638993|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638994|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638995|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638996|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638997|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
638998|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
638999|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
639000|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
639001|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
639002|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
639003|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
639004|NCT00426751|E2|Reported Event|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
639005|NCT00426751|E1|Reported Event|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
639006|NCT00426660|B1|Baseline|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639007|NCT00426660|P1|Participant Flow|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639008|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639009|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639010|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639011|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639012|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639013|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639014|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639015|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639016|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639017|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639018|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639019|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639020|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639021|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639022|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639023|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639024|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639025|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639026|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639027|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639028|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639029|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639030|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639031|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639032|NCT00426660|E1|Reported Event|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
639033|NCT00426556|B5|Baseline|Total|Total of all reporting groups
639034|NCT00426556|B4|Baseline|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639035|NCT00426556|B3|Baseline|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
639036|NCT00426556|B2|Baseline|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639037|NCT00426556|B1|Baseline|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639038|NCT00426556|P4|Participant Flow|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639039|NCT00426556|P3|Participant Flow|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
639040|NCT00426556|P2|Participant Flow|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639041|NCT00426556|P1|Participant Flow|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639042|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639043|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
639044|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639045|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639046|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639047|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
639048|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639049|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639050|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639323|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639051|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
639052|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639053|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639054|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639055|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
639056|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639057|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639058|NCT00426556|E4|Reported Event|Phase II - Everolimus 10mg Daily + PT|Phase II - Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639059|NCT00426556|E3|Reported Event|Phase I - Everolimus 30mg Weekly + PT|Phase I - Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639060|NCT00426556|E2|Reported Event|Phase I - Everolimus 10mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639061|NCT00426556|E1|Reported Event|Phase I - Everolimus 5mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
639062|NCT00426361|B4|Baseline|Total|Total of all reporting groups
639063|NCT00426361|B3|Baseline|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639064|NCT00426361|B2|Baseline|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639065|NCT00426361|B1|Baseline|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639066|NCT00426361|P3|Participant Flow|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639067|NCT00426361|P2|Participant Flow|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639068|NCT00426361|P1|Participant Flow|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639069|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639070|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639071|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639072|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639073|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639074|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639075|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639076|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639077|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639078|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639079|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639080|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639081|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639082|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639083|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639084|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639085|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639086|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639087|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639088|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639324|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639090|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639091|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639092|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639093|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639094|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639095|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639096|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639097|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639098|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639099|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639100|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639101|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639102|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639103|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639104|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639105|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639106|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639107|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639108|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639109|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639110|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639111|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639112|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639113|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639114|NCT00426361|E3|Reported Event|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
639115|NCT00426361|E2|Reported Event|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
639116|NCT00426361|E1|Reported Event|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
639117|NCT00426283|B3|Baseline|Total|Total of all reporting groups
639118|NCT00426283|B2|Baseline|Placebo 1760 mcg|Placebo : 1760 mcg daily
639119|NCT00426283|B1|Baseline|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
639120|NCT00426283|P2|Participant Flow|Placebo 1760 mcg|Placebo : 1760 mcg daily
639121|NCT00426283|P1|Participant Flow|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
639122|NCT00426283|O2|Outcome|Placebo 1760 mcg|Placebo : 1760 mcg daily
639123|NCT00426283|O1|Outcome|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
639124|NCT00426283|E2|Reported Event|Placebo 1760 mcg|Placebo : 1760 mcg daily
639125|NCT00426283|E1|Reported Event|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
639126|NCT00426270|B1|Baseline|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639127|NCT00426270|P1|Participant Flow|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639128|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639129|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639130|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639131|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639132|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639133|NCT00426270|E1|Reported Event|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
639134|NCT00426231|B3|Baseline|Total|Total of all reporting groups
639135|NCT00426231|B2|Baseline|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
639136|NCT00426231|B1|Baseline|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
639137|NCT00426231|P2|Participant Flow|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
639138|NCT00426231|P1|Participant Flow|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
639139|NCT00426231|O2|Outcome|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
639140|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
639141|NCT00426231|O2|Outcome|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
639142|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
639143|NCT00426231|E2|Reported Event|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
639144|NCT00426231|E1|Reported Event|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
639145|NCT00426153|B3|Baseline|Total|Total of all reporting groups
639146|NCT00426153|B2|Baseline|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
639147|NCT00426153|B1|Baseline|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
639148|NCT00426153|P2|Participant Flow|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
639149|NCT00426153|P1|Participant Flow|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
639150|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
639151|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
639152|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
639153|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
639154|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
639155|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
639156|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
639157|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
639158|NCT00426153|E2|Reported Event|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
639159|NCT00426153|E1|Reported Event|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
639160|NCT00426127|B1|Baseline|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
639161|NCT00426127|P1|Participant Flow|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
639162|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
639163|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
639164|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
639165|NCT00426127|E1|Reported Event|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
639166|NCT00425945|B3|Baseline|Total|Total of all reporting groups
639167|NCT00425945|B2|Baseline|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639168|NCT00425945|B1|Baseline|Pine Bark Extract|200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily. Pine Bark Extract (Flavangenol�) : Flavangenol 200 mg per day. Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks.
639169|NCT00425945|P2|Participant Flow|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639170|NCT00425945|P1|Participant Flow|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639171|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639172|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639173|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639174|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639175|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639176|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639177|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639178|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639179|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639180|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639181|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639182|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639183|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639184|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639185|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639186|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639187|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639188|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639189|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639190|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639191|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639192|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639193|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639194|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639195|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639196|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639197|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639198|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639199|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639200|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639201|NCT00425945|O2|Outcome|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639202|NCT00425945|O1|Outcome|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639203|NCT00425945|E2|Reported Event|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
639204|NCT00425945|E1|Reported Event|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
639205|NCT00425854|B3|Baseline|Total|Total of all reporting groups
639206|NCT00425854|B2|Baseline|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639207|NCT00425854|B1|Baseline|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639208|NCT00425854|P2|Participant Flow|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639209|NCT00425854|P1|Participant Flow|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639210|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639211|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639212|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639213|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639214|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639215|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639216|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639217|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639218|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639219|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639220|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639374|NCT00425308|B3|Baseline|Total|Total of all reporting groups
649810|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
639221|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639222|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639223|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639224|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639225|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639226|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639227|NCT00425854|E2|Reported Event|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
639228|NCT00425854|E1|Reported Event|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
639229|NCT00425802|B1|Baseline|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639230|NCT00425802|P1|Participant Flow|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639231|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639232|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639233|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639234|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639235|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639236|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639237|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639262|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
649811|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
639238|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639239|NCT00425802|O1|Outcome|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639240|NCT00425802|E1|Reported Event|Treatment|This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
639241|NCT00425750|B1|Baseline|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
639242|NCT00425750|P1|Participant Flow|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
639243|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
639244|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
639245|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
639246|NCT00425750|E1|Reported Event|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
639247|NCT00425698|B3|Baseline|Total|Total of all reporting groups
639248|NCT00425698|B2|Baseline|Placebo|
639249|NCT00425698|B1|Baseline|Erythropoietin|
639250|NCT00425698|P2|Participant Flow|Placebo|
639251|NCT00425698|P1|Participant Flow|Erythropoietin|
639252|NCT00425698|O2|Outcome|Placebo|
639253|NCT00425698|O1|Outcome|Erythropoietin|
639254|NCT00425698|E2|Reported Event|Placebo|
639255|NCT00425698|E1|Reported Event|Erythropoietin|
639256|NCT00425672|B1|Baseline|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639257|NCT00425672|P1|Participant Flow|ONTAK|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639258|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639259|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639260|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639261|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639320|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
649812|NCT00402987|O4|Outcome|Placebo|
639263|NCT00425672|O1|Outcome|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639264|NCT00425672|E1|Reported Event|Arm I|"Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ONTAK: Given IV~flow cytometry: Correlative studies~immunohistochemistry staining method: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~laboratory biomarker analysis: Correlative studies~protein expression analysis: Correlative studies"
639265|NCT00425607|B1|Baseline|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
639266|NCT00425607|P1|Participant Flow|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
639267|NCT00425607|O1|Outcome|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
639268|NCT00425607|E1|Reported Event|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo. Patients were monitored for liver, kidney, and hematological toxicity each month for the first 3 mo by their local physicians and every 4 mo in Boston for the duration of the study. Adverse events were monitored and recorded throughout the study.
639269|NCT00425503|B1|Baseline|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
639270|NCT00425503|P1|Participant Flow|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
639271|NCT00425503|O1|Outcome|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
639272|NCT00425503|E1|Reported Event|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
639273|NCT00425438|B3|Baseline|Total|Total of all reporting groups
639274|NCT00425438|B2|Baseline|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639275|NCT00425438|B1|Baseline|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639276|NCT00425438|P2|Participant Flow|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639277|NCT00425438|P1|Participant Flow|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639321|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639322|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639278|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639279|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639280|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639281|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639282|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639283|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639284|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639285|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639286|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639287|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639288|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
649813|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
639289|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639290|NCT00425438|E2|Reported Event|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639291|NCT00425438|E1|Reported Event|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
639292|NCT00425386|B1|Baseline|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639293|NCT00425386|P1|Participant Flow|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639294|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639295|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639296|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639297|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639298|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639299|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639300|NCT00425386|E1|Reported Event|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
639301|NCT00425373|B10|Baseline|Total|Total of all reporting groups
639302|NCT00425373|B9|Baseline|Placebo|4 tablet and 2 capsule placebos taken once daily
639303|NCT00425373|B8|Baseline|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639304|NCT00425373|B7|Baseline|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639305|NCT00425373|B6|Baseline|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639306|NCT00425373|B5|Baseline|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639307|NCT00425373|B4|Baseline|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639308|NCT00425373|B3|Baseline|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639309|NCT00425373|B2|Baseline|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639310|NCT00425373|B1|Baseline|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639311|NCT00425373|P9|Participant Flow|Placebo|4 tablet and 2 capsule placebos taken once daily
639312|NCT00425373|P8|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639313|NCT00425373|P7|Participant Flow|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639314|NCT00425373|P6|Participant Flow|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639315|NCT00425373|P5|Participant Flow|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639316|NCT00425373|P4|Participant Flow|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639317|NCT00425373|P3|Participant Flow|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639318|NCT00425373|P2|Participant Flow|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639319|NCT00425373|P1|Participant Flow|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639325|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639326|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639327|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639328|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639329|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
639330|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639331|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639332|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639333|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639334|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639335|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639336|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639337|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639338|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
639339|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639340|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639341|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639342|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639343|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639344|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639345|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639346|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639347|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
639348|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639349|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639350|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639351|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639352|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639353|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639354|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639355|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639356|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
639357|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639358|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639359|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639360|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639361|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639362|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639363|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639364|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639365|NCT00425373|E9|Reported Event|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639366|NCT00425373|E8|Reported Event|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639367|NCT00425373|E7|Reported Event|Amlodipine 5 mg|Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily
639368|NCT00425373|E6|Reported Event|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639369|NCT00425373|E5|Reported Event|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639370|NCT00425373|E4|Reported Event|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
639371|NCT00425373|E3|Reported Event|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639372|NCT00425373|E2|Reported Event|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
639373|NCT00425373|E1|Reported Event|Placebo|4 tablet and 2 capsule placebos taken once daily
639375|NCT00425308|B2|Baseline|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639376|NCT00425308|B1|Baseline|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639377|NCT00425308|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639378|NCT00425308|P1|Participant Flow|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639379|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639380|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639381|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639382|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639383|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639384|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639385|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639386|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639387|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639388|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639389|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639390|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639391|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639392|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639393|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639394|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639395|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639396|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
649814|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
639397|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639398|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639399|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639400|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639401|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639402|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639403|NCT00425308|E2|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
639404|NCT00425308|E1|Reported Event|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
639405|NCT00425269|B3|Baseline|Total|Total of all reporting groups
639406|NCT00425269|B2|Baseline|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
639407|NCT00425269|B1|Baseline|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639408|NCT00425269|P2|Participant Flow|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
639409|NCT00425269|P1|Participant Flow|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639410|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639411|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639412|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639413|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639414|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639415|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639416|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639434|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639417|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639418|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639419|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639420|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639421|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639422|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639423|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639424|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639425|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639426|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639427|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639428|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639429|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639430|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639431|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639432|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639433|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639435|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639436|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639437|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639438|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639439|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639440|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639441|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639442|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639443|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639444|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639445|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639446|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639447|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639448|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639449|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639450|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639451|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639452|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639453|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639454|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639455|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639456|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639457|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639458|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639459|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639460|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639461|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639462|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639463|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639464|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639465|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639466|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639467|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639468|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639489|NCT00425113|O2|Outcome|Placebo|
639490|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
639491|NCT00425113|O2|Outcome|Placebo|
639469|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639470|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639471|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639472|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639473|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639474|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639475|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639476|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639477|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639478|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639479|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639480|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639481|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639482|NCT00425269|E2|Reported Event|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
639483|NCT00425269|E1|Reported Event|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
639484|NCT00425113|B3|Baseline|Total|Total of all reporting groups
639485|NCT00425113|B2|Baseline|Placebo|
639486|NCT00425113|B1|Baseline|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
639487|NCT00425113|P2|Participant Flow|Placebo|
639488|NCT00425113|P1|Participant Flow|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
639492|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg three times daily or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
639493|NCT00425113|E2|Reported Event|Placebo|
639494|NCT00425113|E1|Reported Event|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
639495|NCT00425100|B1|Baseline|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
639496|NCT00425100|P1|Participant Flow|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
639497|NCT00425100|O1|Outcome|Open Label Week 12|
639498|NCT00425100|O2|Outcome|Open Label Week 12|
639499|NCT00425100|O1|Outcome|Open Label Baseline|
639500|NCT00425100|O1|Outcome|Open Label Week 12|
639501|NCT00425100|O2|Outcome|Open Label Week 12|
639502|NCT00425100|O1|Outcome|Open Label Baseline|
639503|NCT00425100|O2|Outcome|Open Label Week 12|
639504|NCT00425100|O1|Outcome|Open Label Baseline|
639505|NCT00425100|O2|Outcome|Open Label Week 12|
639506|NCT00425100|O1|Outcome|Open Label Baseline|
639507|NCT00425100|O2|Outcome|Open Label Week 12|
639508|NCT00425100|O1|Outcome|Open Label Baseline|
639509|NCT00425100|O2|Outcome|Open Label Week 12|
639510|NCT00425100|O1|Outcome|Open Label Baseline|
639511|NCT00425100|O2|Outcome|Open Label Week 12|
639512|NCT00425100|O1|Outcome|Open Label Baseline|
639513|NCT00425100|O1|Outcome|Open Label Week 12|
639514|NCT00425100|O2|Outcome|Open Label Week 12|
639515|NCT00425100|O1|Outcome|Open Label Baseline|
639516|NCT00425100|O1|Outcome|Open Label Week 12|
639517|NCT00425100|O2|Outcome|Open Label Week 12|
639518|NCT00425100|O1|Outcome|Open Label Baseline|
639519|NCT00425100|O2|Outcome|Open Label Week 12|
639520|NCT00425100|O1|Outcome|Open Label Baseline|
639521|NCT00425100|O2|Outcome|Open Label Week 12|
639522|NCT00425100|O1|Outcome|Open Label Baseline|
639523|NCT00425100|O2|Outcome|Open Label Week 12|
639524|NCT00425100|O1|Outcome|Open Label Baseline|
639525|NCT00425100|O1|Outcome|Open Label Week 12|
639526|NCT00425100|O2|Outcome|Open Label Week 12|
639527|NCT00425100|O1|Outcome|Open Label Baseline|
639528|NCT00425100|O2|Outcome|Open Label Week 12|
639529|NCT00425100|O1|Outcome|Open Label Baseline|
639530|NCT00425100|O2|Outcome|Open Label Week 12|
639531|NCT00425100|O1|Outcome|Open Label Baseline|
639532|NCT00425061|B8|Baseline|Total|Total of all reporting groups
639533|NCT00425061|B7|Baseline|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639534|NCT00425061|B6|Baseline|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639535|NCT00425061|B5|Baseline|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639536|NCT00425061|B4|Baseline|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639537|NCT00425061|B3|Baseline|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639538|NCT00425061|B2|Baseline|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639539|NCT00425061|B1|Baseline|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639540|NCT00425061|P7|Participant Flow|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639541|NCT00425061|P6|Participant Flow|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639542|NCT00425061|P5|Participant Flow|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639543|NCT00425061|P4|Participant Flow|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639544|NCT00425061|P3|Participant Flow|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639545|NCT00425061|P2|Participant Flow|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639546|NCT00425061|P1|Participant Flow|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639547|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639548|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639549|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639550|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639551|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639552|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639553|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639554|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639555|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639556|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639557|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639558|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639559|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639560|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639561|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639562|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639563|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639564|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639565|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639566|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639567|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639568|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639569|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639570|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639571|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639572|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639573|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639574|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639575|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639576|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639577|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639578|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639579|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639580|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639581|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639582|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639583|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639584|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639585|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639586|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639587|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639588|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639589|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639590|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639591|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639592|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639593|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639594|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639595|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639596|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639597|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639598|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639599|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639600|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
640493|NCT00423943|O2|Outcome|Placebo|"placebo~modafinil: 200 milligrams daily dose"
639601|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639602|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639603|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639604|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639605|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639606|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639607|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639608|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639609|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639610|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639611|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639612|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639613|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639614|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639615|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639616|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639617|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639618|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639619|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639620|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639621|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639622|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639623|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639624|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639625|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639626|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639627|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639628|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639629|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639630|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639631|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639632|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639633|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639634|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639635|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639636|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639637|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639638|NCT00425061|O2|Outcome|Placebo|Included all participants who received placebo matched to IMA-638 subcutaneous injection during Stage 1, 2 or 3.
639639|NCT00425061|O1|Outcome|IMA-638|Included participants who received any dose of IMA-638 subcutaneous injection during Stage 1, 2 or 3.
639640|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639641|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639642|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639643|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639644|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639645|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
640494|NCT00423943|O1|Outcome|Drug|"modafinil~modafinil: 200 milligrams daily dose"
639646|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639647|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639648|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639649|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639650|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639651|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639652|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639653|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639654|NCT00425061|E7|Reported Event|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639655|NCT00425061|E6|Reported Event|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
639656|NCT00425061|E5|Reported Event|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
639657|NCT00425061|E4|Reported Event|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639658|NCT00425061|E3|Reported Event|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639659|NCT00425061|E2|Reported Event|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639660|NCT00425061|E1|Reported Event|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
639661|NCT00424827|B1|Baseline|This Was a Prospective, Single Arm, Open Label Pilot Phase II|"A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil, and Radiation Therapy in Locally Advanced Nonmetastatic Pancreatic Adenocarcinoma~This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.~Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases. The purpose of this study is to evaluate the efficacy and safety of cetuximab in combination with gemcitabine and 5-FU along with radiation therapy in locally advanced non-resectable, pancreatic adenocarcinoma, using progression free survival as the primary end point."
639662|NCT00424827|P1|Participant Flow|Single Arm|"This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.~Gemcitabine/Fluorouracil with External Beam Radiation: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma."
639663|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
639664|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
639665|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
639666|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
639667|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|Progression-free survival
639668|NCT00424827|E1|Reported Event|Gemcitabine/Fluorouracil With External Beam Radiation|antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
639669|NCT00424775|B1|Baseline|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
639670|NCT00424775|P2|Participant Flow|Vorinostat (400 mg)|This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily.
639671|NCT00424775|P1|Participant Flow|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
639672|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
639673|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
639674|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
639675|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
639676|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
639874|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639677|NCT00424775|E1|Reported Event|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
639678|NCT00424762|B3|Baseline|Total|Total of all reporting groups
639679|NCT00424762|B2|Baseline|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
639680|NCT00424762|B1|Baseline|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
639681|NCT00424762|P2|Participant Flow|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
639682|NCT00424762|P1|Participant Flow|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
639683|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
639684|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
639685|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
639686|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
639687|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
639688|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
639689|NCT00424762|E2|Reported Event|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
639690|NCT00424762|E1|Reported Event|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
639691|NCT00424749|B1|Baseline|Rituximab|375 mg/m^2/week for 4 weeks
639692|NCT00424749|P1|Participant Flow|Rituximab|375 mg/m^2/week for 4 weeks
639693|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
639694|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
639695|NCT00424749|E1|Reported Event|Rituximab|375 mg/m^2/week for 4 weeks
639696|NCT00424645|B3|Baseline|Total|Total of all reporting groups
639697|NCT00424645|B2|Baseline|Placebo|Placebo administered IV following Voraxaze arm.
639698|NCT00424645|B1|Baseline|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
639699|NCT00424645|P2|Participant Flow|Placebo|Placebo administered IV following Voraxaze arm.
639700|NCT00424645|P1|Participant Flow|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
639701|NCT00424645|O2|Outcome|Placebo|Placebo administered IV following Voraxaze arm.
639702|NCT00424645|O1|Outcome|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
639703|NCT00424645|E2|Reported Event|Placebo|Placebo administered IV following Voraxaze arm.
639704|NCT00424645|E1|Reported Event|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
639705|NCT00424632|B3|Baseline|Total|Total of all reporting groups
639706|NCT00424632|B2|Baseline|PF-03814735 (Schedule B)|Participants received daily dosing of PF-03814735 of 40, 50, or 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639707|NCT00424632|B1|Baseline|PF-03814735 (Schedule A)|Participants received daily dosing of PF-03814735 of 5, 10, 20, 40, 60, 80, or 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639708|NCT00424632|P10|Participant Flow|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639709|NCT00424632|P9|Participant Flow|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639710|NCT00424632|P8|Participant Flow|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639711|NCT00424632|P7|Participant Flow|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639712|NCT00424632|P6|Participant Flow|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639713|NCT00424632|P5|Participant Flow|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639714|NCT00424632|P4|Participant Flow|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639715|NCT00424632|P3|Participant Flow|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639716|NCT00424632|P2|Participant Flow|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639875|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
640495|NCT00423943|O2|Outcome|Placebo|"placebo~modafinil: 200 milligrams daily dose"
639717|NCT00424632|P1|Participant Flow|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639718|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639719|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639720|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639721|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639722|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639723|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639724|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639725|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639726|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639727|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639728|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639729|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639730|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639731|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639732|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639733|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639734|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639735|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639736|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639737|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639738|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639739|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639740|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639741|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639742|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639743|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639744|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639745|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639876|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639746|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639747|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639748|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639749|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639750|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639751|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639752|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639753|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639754|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639755|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639756|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639757|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639758|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639759|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639760|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639761|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
639762|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639763|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639764|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639765|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639766|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639767|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639768|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639769|NCT00424632|O3|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639770|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639771|NCT00424632|O1|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639772|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639773|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639774|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
640496|NCT00423943|O1|Outcome|Drug|"modafinil~modafinil: 200 milligrams daily dose"
639775|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
639776|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639777|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639778|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639779|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639780|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639781|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639782|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639783|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639784|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639785|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639786|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
639787|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639788|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639789|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639790|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639791|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639792|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639793|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639794|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639795|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639796|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639797|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
639798|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639799|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639800|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639801|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639802|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639877|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639803|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639804|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639805|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639806|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639807|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639808|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
639809|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639810|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639811|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639812|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639813|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639814|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639815|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639816|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639817|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639818|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639819|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
639820|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639821|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639822|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639823|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639824|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639825|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639826|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639827|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639828|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639829|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639830|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639831|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639832|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639833|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639834|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639835|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639836|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639837|NCT00424632|E10|Reported Event|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639838|NCT00424632|E9|Reported Event|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639839|NCT00424632|E8|Reported Event|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
639840|NCT00424632|E7|Reported Event|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639841|NCT00424632|E6|Reported Event|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639842|NCT00424632|E5|Reported Event|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639843|NCT00424632|E4|Reported Event|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639844|NCT00424632|E3|Reported Event|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639845|NCT00424632|E2|Reported Event|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639846|NCT00424632|E1|Reported Event|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
639847|NCT00424619|B4|Baseline|Total|Total of all reporting groups
639848|NCT00424619|B3|Baseline|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639849|NCT00424619|B2|Baseline|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639850|NCT00424619|B1|Baseline|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639851|NCT00424619|P3|Participant Flow|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639852|NCT00424619|P2|Participant Flow|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639853|NCT00424619|P1|Participant Flow|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639854|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639855|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639856|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639857|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639858|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639859|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639860|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639861|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639862|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639863|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639864|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639865|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639866|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639867|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639868|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639869|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639870|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639871|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639872|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639873|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639879|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639880|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639881|NCT00424619|E3|Reported Event|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
639882|NCT00424619|E2|Reported Event|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639883|NCT00424619|E1|Reported Event|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
639884|NCT00424593|B3|Baseline|Total|Total of all reporting groups
639885|NCT00424593|B2|Baseline|Placebo|every day (QD), by mouth (PO), 13 weeks
639886|NCT00424593|B1|Baseline|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639887|NCT00424593|P2|Participant Flow|Placebo|every day (QD), by mouth (PO), 13 weeks
639888|NCT00424593|P1|Participant Flow|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639889|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639890|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639891|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639892|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639893|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639894|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639895|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639896|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639897|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639898|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639899|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639900|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639901|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639902|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639903|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639904|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639905|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639906|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639907|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639908|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639909|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639910|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639911|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639912|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639913|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639914|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639915|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639916|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639918|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639919|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639920|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639921|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639922|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639923|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639924|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639925|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639926|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639927|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
639928|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639929|NCT00424593|E2|Reported Event|Placebo|every day (QD), by mouth (PO), 13 weeks
639930|NCT00424593|E1|Reported Event|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
639931|NCT00424554|B3|Baseline|Total|Total of all reporting groups
639932|NCT00424554|B2|Baseline|No Intervention|No pre-surgery treatment with temozolomide
639933|NCT00424554|B1|Baseline|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639934|NCT00424554|P2|Participant Flow|No Intervention|No pre-surgery treatment with temozolomide
639935|NCT00424554|P1|Participant Flow|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639936|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
639937|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639938|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
639939|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639940|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
639941|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639942|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
639943|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639944|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
639945|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639946|NCT00424554|E2|Reported Event|No Intervention|No pre-surgery treatment with temozolomide
639947|NCT00424554|E1|Reported Event|Temozolomide|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
639948|NCT00424528|B4|Baseline|Total|Total of all reporting groups
639949|NCT00424528|B3|Baseline|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639950|NCT00424528|B2|Baseline|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639951|NCT00424528|B1|Baseline|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639952|NCT00424528|P3|Participant Flow|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639953|NCT00424528|P2|Participant Flow|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639954|NCT00424528|P1|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639955|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639956|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639957|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639958|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639959|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639960|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
649815|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
639961|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639962|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639963|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639964|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639965|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639966|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639967|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639968|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639969|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639970|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639971|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639972|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639973|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639974|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639975|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639976|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639977|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639978|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639979|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639980|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639981|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639982|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639983|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639984|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639985|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639986|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639987|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639988|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639989|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639990|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639991|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639992|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639993|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639994|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639995|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639996|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
639997|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
639998|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
639999|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
640000|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
640001|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
640002|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
640003|NCT00424528|E3|Reported Event|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
640004|NCT00424528|E2|Reported Event|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
640005|NCT00424528|E1|Reported Event|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
640006|NCT00424515|B3|Baseline|Total|Total of all reporting groups
640007|NCT00424515|B2|Baseline|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640008|NCT00424515|B1|Baseline|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640009|NCT00424515|P2|Participant Flow|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
649816|NCT00402987|O3|Outcome|Placebo|
640010|NCT00424515|P1|Participant Flow|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640011|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640012|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640013|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640014|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640015|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640016|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640017|NCT00424515|E2|Reported Event|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640018|NCT00424515|E1|Reported Event|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
640019|NCT00424502|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640020|NCT00424502|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) and methylprednisolone 100 mg IV on Days 0 and 14.
640021|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640022|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640023|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640024|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640025|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640026|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640027|NCT00424502|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
640028|NCT00424476|B4|Baseline|Total|Total of all reporting groups
640029|NCT00424476|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640030|NCT00424476|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640031|NCT00424476|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640032|NCT00424476|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640033|NCT00424476|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640034|NCT00424476|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640035|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640036|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640037|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640038|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640039|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640497|NCT00423943|O2|Outcome|Placebo|"placebo~modafinil: 200 milligrams daily dose"
640040|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640041|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640042|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640043|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640044|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640045|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640046|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640047|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640048|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640049|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640050|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640051|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640052|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640053|NCT00424476|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640054|NCT00424476|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640055|NCT00424476|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
640056|NCT00424398|B4|Baseline|Total|Total of all reporting groups
640057|NCT00424398|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640058|NCT00424398|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640059|NCT00424398|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640060|NCT00424398|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640061|NCT00424398|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640062|NCT00424398|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640063|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640064|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640065|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640066|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640067|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640068|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640069|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640070|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640071|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640072|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640073|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640074|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640075|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640076|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640077|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640078|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640079|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640080|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640081|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640082|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640083|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640084|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640085|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640086|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640087|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640088|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640089|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640090|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640091|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640092|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640093|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640094|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640095|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640096|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640097|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640098|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640099|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640100|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640101|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640102|NCT00424398|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640103|NCT00424398|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640104|NCT00424398|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
640105|NCT00424385|B1|Baseline|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
640106|NCT00424385|P1|Participant Flow|Imatinib + Sorafenib|"Both drugs, Gleevec + Sorafenib are given to all patients on study. There are 4 potential cohorts. Each will enroll 3 evaluable (patients that complete 2 cycles of treatment) patients. If a Dose Limiting Toxicity is demonstrated in a cohort, an additional 3 evaluable patients can be enrolled in that cohort.~Cohort 0 was 400mg Sorafenib every day (QD)and 300mg of Imatinib QD. Cohort 1 was 400mg Sorafenib two times a day and 300mg QD Imatinib."
640107|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
640108|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
640109|NCT00424385|O2|Outcome|Imatinib + Sorafenib Cohort 1|300mg every day (QD) Imatinib + 400mg twice daily (BID)Sorafenib, by mouth
640110|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0|300mg every day (QD)Imatinib + 400mg every day (QD) Sorafenib, by mouth
640111|NCT00424385|E1|Reported Event|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
649817|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
640112|NCT00424372|B1|Baseline|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640113|NCT00424372|P1|Participant Flow|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640114|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640115|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640116|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640117|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640118|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640119|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
640120|NCT00424346|B5|Baseline|Total|Total of all reporting groups
640121|NCT00424346|B4|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640122|NCT00424346|B3|Baseline|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640123|NCT00424346|B2|Baseline|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640124|NCT00424346|B1|Baseline|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640125|NCT00424346|P4|Participant Flow|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640126|NCT00424346|P3|Participant Flow|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640127|NCT00424346|P2|Participant Flow|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640128|NCT00424346|P1|Participant Flow|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. Participants in this treatment group who participated in the Extension Phase are represented in the 'Canakinumab 300 mg q2wk' treatment group in the Extension Phase table below.
640129|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640301|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640302|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
640130|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640131|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640132|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640133|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640134|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640135|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640136|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640137|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640138|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640139|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640140|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640141|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640142|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640143|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640144|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640145|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640146|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640147|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640148|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640149|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640150|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640151|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640152|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640153|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640154|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640155|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640156|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640157|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640158|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640159|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640160|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640161|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640162|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640163|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640164|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640165|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640166|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640224|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640167|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
640168|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640169|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640170|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640171|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640172|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640173|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640174|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640175|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640176|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640177|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640178|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640179|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640180|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640181|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640182|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640183|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640184|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640185|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640303|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640304|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
640186|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640187|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640188|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640189|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640190|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640191|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640192|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640193|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640194|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640195|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640196|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640197|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640198|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640199|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640200|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640201|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640202|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640203|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640204|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640249|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640205|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640206|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640207|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640208|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640209|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640210|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640211|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640212|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640213|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640214|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640215|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640216|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640217|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640218|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640219|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640220|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640221|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640222|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640223|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640296|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
640297|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640225|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640226|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640227|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640228|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640229|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640230|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640231|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640232|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640233|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640234|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
640235|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
640236|NCT00424346|E4|Reported Event|Placebo|Placebo
640237|NCT00424346|E3|Reported Event|ACZ885 150mg sc q4wk|ACZ885 150mg sc q4wk
640238|NCT00424346|E2|Reported Event|ACZ885 300mg sc q2wk|ACZ885 300mg sc q2wk
640239|NCT00424346|E1|Reported Event|ACZ885 600mg iv + 300mg sc q2wk|ACZ885 600mg iv + 300mg sc q2wk
640240|NCT00424294|B3|Baseline|Total|Total of all reporting groups
640241|NCT00424294|B2|Baseline|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640242|NCT00424294|B1|Baseline|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640243|NCT00424294|P2|Participant Flow|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640244|NCT00424294|P1|Participant Flow|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640245|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640246|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640247|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640248|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640250|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640251|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640252|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640253|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640254|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640255|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640256|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640257|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640258|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640259|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640260|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640261|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640262|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640263|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640264|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640265|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640266|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640267|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640268|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640269|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640270|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640298|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
640299|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640271|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640272|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640273|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640274|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640275|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640276|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640277|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640278|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640279|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640280|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640281|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640282|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640283|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640284|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640285|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640286|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640287|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640288|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640289|NCT00424294|E2|Reported Event|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
640290|NCT00424294|E1|Reported Event|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
640291|NCT00424268|B3|Baseline|Total|Total of all reporting groups
640292|NCT00424268|B2|Baseline|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
640293|NCT00424268|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640294|NCT00424268|P2|Participant Flow|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
640295|NCT00424268|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640305|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640306|NCT00424268|E2|Reported Event|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
640307|NCT00424268|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
640308|NCT00424255|B3|Baseline|Total|Total of all reporting groups
640309|NCT00424255|B2|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640310|NCT00424255|B1|Baseline|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640311|NCT00424255|P2|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640312|NCT00424255|P1|Participant Flow|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640313|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640314|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640315|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640316|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640317|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640318|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640379|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
640380|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
640381|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
640319|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640320|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640321|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640322|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640323|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640324|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640325|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640326|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640327|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640328|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640329|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640382|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
640383|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
640330|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640331|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640332|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640333|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640334|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640335|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640336|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640337|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640338|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640339|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640340|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640384|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
640385|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
640341|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640342|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640343|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640344|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640345|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640346|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640347|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640348|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640349|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640350|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640351|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640386|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
640498|NCT00423943|O1|Outcome|Drug|"modafinil~modafinil: 200 milligrams daily dose"
640352|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640353|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640354|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640355|NCT00424255|E2|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640356|NCT00424255|E1|Reported Event|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
640357|NCT00424190|B3|Baseline|Total|Total of all reporting groups
640358|NCT00424190|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
640359|NCT00424190|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
640360|NCT00424190|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
640361|NCT00424190|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
640362|NCT00424190|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
640363|NCT00424190|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
640364|NCT00424190|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
640365|NCT00424190|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
640366|NCT00424177|B1|Baseline|Overall Study Population|Male and female participants greater than or equal to 18 years of age with previously treated chronic ITP, as defined according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, who had platelet counts between greater than or equal to 20 gi/L and less than or equal to 50 Gi/L, on the Day 1 visit (or within 24 hours prior to dosing on Day 1).
640367|NCT00424177|P1|Participant Flow|Treatment Period|Three cycles of treatment. A cycle is defined as an on-therapy period of up to 6 weeks and an off-therapy period of up to 4 weeks.
640368|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
640369|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
640370|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
640371|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
640372|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
640373|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
640374|NCT00424177|O1|Outcome|Overall Study|
640375|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
640376|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
640377|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
640378|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
649818|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
640387|NCT00424177|E6|Reported Event|All Cycles|Participants who reported an AE anytime during 3 cycles of treatment. A cycle consisted of once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy.
640388|NCT00424177|E5|Reported Event|More Than 30 Days After Last Dose|Adverse events >30 days after last dose (Post-therapy)
640389|NCT00424177|E4|Reported Event|More Than 1 to 30 Days After Last Dose|Adverse events >1 to 30 days after last dose (Post-therapy)
640390|NCT00424177|E3|Reported Event|Cycle 3|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
640391|NCT00424177|E2|Reported Event|Cycle 2|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
640392|NCT00424177|E1|Reported Event|Cycle 1|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
640393|NCT00424047|B3|Baseline|Total|Total of all reporting groups
640394|NCT00424047|B2|Baseline|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640395|NCT00424047|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640396|NCT00424047|P2|Participant Flow|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
640397|NCT00424047|P1|Participant Flow|Lenalidomide Plus Dexamethasone (Len/Dex)|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640398|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
640399|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640400|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
640401|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640402|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640403|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640404|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
640405|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640406|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640499|NCT00423943|O2|Outcome|Placebo|"placebo~modafinil: 200 milligrams daily dose"
649819|NCT00402987|O3|Outcome|Placebo|
640407|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640408|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640409|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640410|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
640411|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640412|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
640413|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640414|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640415|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640416|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
640417|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640418|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640419|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640420|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640421|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640422|NCT00424047|E2|Reported Event|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
640486|NCT00424008|E2|Reported Event|MF/F MDI * 200/10 MCG * BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
640487|NCT00424008|E1|Reported Event|Open-label (OL) MF MDI * 200 MCG BID|Mometasone furoate 200 mcg taken twice daily (BID) via a metered-dose inhaler (MDI).
640423|NCT00424047|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
640424|NCT00424021|B5|Baseline|Total|Total of all reporting groups
640425|NCT00424021|B4|Baseline|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640426|NCT00424021|B3|Baseline|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640427|NCT00424021|B2|Baseline|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
640428|NCT00424021|B1|Baseline|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
640429|NCT00424021|P4|Participant Flow|10 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640430|NCT00424021|P3|Participant Flow|5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640431|NCT00424021|P2|Participant Flow|2.5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
640432|NCT00424021|P1|Participant Flow|1 mg|The optimized final dose from the open-label period of AMB 220 (given once daily [QD] by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
640433|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640434|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640435|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
640436|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
640437|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640438|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640439|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
640440|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
640441|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640442|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640443|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640444|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640488|NCT00423943|B3|Baseline|Total|Total of all reporting groups
640445|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640446|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640447|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640448|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
640449|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640450|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640451|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640452|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640453|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
640454|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640455|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640456|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640457|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640458|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
640489|NCT00423943|B2|Baseline|Placebo|"placebo~modafinil: 200 milligrams daily dose"
640490|NCT00423943|B1|Baseline|Drug|"modafinil~modafinil: 200 milligrams daily dose"
640491|NCT00423943|P2|Participant Flow|Placebo|"placebo~modafinil: 200 milligrams daily dose"
640459|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640460|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640461|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640462|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
640463|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
640464|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640465|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640466|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
640467|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
640468|NCT00424021|E4|Reported Event|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640469|NCT00424021|E3|Reported Event|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
640470|NCT00424021|E2|Reported Event|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
640471|NCT00424021|E1|Reported Event|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
640472|NCT00424008|B3|Baseline|Total|Total of all reporting groups
640473|NCT00424008|B2|Baseline|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
640474|NCT00424008|B1|Baseline|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
640475|NCT00424008|P2|Participant Flow|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
640476|NCT00424008|P1|Participant Flow|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
640477|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
640478|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
640479|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
640480|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
640481|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
640482|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
640483|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
640484|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
640485|NCT00424008|E3|Reported Event|F/SC DPI * 250/50 MCG BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
640492|NCT00423943|P1|Participant Flow|Drug|"modafinil~modafinil: 200 milligrams daily dose"
640500|NCT00423943|O1|Outcome|Drug|"modafinil~modafinil: 200 milligrams daily dose"
640501|NCT00423943|O2|Outcome|Placebo|"placebo~modafinil: 200 milligrams daily dose"
640502|NCT00423943|O1|Outcome|Drug|"modafinil~modafinil: 200 milligrams daily dose"
640503|NCT00423943|E2|Reported Event|Placebo|"placebo~modafinil: 200 milligrams daily dose"
640504|NCT00423943|E1|Reported Event|Drug|"modafinil~modafinil: 200 milligrams daily dose"
640505|NCT00423930|B1|Baseline|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
640506|NCT00423930|P1|Participant Flow|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
640507|NCT00423930|O1|Outcome|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
640508|NCT00423930|O1|Outcome|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
640509|NCT00423930|E1|Reported Event|IMRT + Cisplatin + Bevacizumab|"This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.~bevacizumab~cisplatin~conventional surgery~intensity-modulated radiation therapy"
640510|NCT00423917|B1|Baseline|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640511|NCT00423917|P1|Participant Flow|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640512|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640513|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640514|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640515|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640596|NCT00423878|P1|Participant Flow|Switch Group|Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day.
640597|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
640598|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
649820|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
640516|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640517|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640518|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640519|NCT00423917|E1|Reported Event|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
640520|NCT00423891|B4|Baseline|Total|Total of all reporting groups
640521|NCT00423891|B3|Baseline|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640522|NCT00423891|B2|Baseline|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640523|NCT00423891|B1|Baseline|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640524|NCT00423891|P3|Participant Flow|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640525|NCT00423891|P2|Participant Flow|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640526|NCT00423891|P1|Participant Flow|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640599|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
640600|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
640601|NCT00423878|E2|Reported Event|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
640602|NCT00423878|E1|Reported Event|Switch Group|Participants will switch to aripiprazole.
640527|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640528|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640529|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640530|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640531|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640532|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640533|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640534|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640535|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640536|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640537|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640635|NCT00423735|B2|Baseline|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640538|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640539|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640540|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640541|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640542|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640543|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640544|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640545|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640546|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640547|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640548|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640636|NCT00423735|B1|Baseline|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
649821|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
640549|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640550|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640551|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640552|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640553|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640554|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640555|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640556|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640557|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640558|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640559|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640666|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
649822|NCT00402987|O4|Outcome|Placebo|
640560|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640561|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640562|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640563|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640564|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640565|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640566|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640567|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640568|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640569|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640570|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640637|NCT00423735|P3|Participant Flow|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640571|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640572|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640573|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640574|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640575|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640576|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640577|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640578|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640579|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640580|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640581|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640664|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
649823|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
640582|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640583|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640584|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640585|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640586|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640587|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640588|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640589|NCT00423891|E3|Reported Event|Group C NA-exp|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
640590|NCT00423891|E2|Reported Event|Group B LVD-exp|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640591|NCT00423891|E1|Reported Event|Group A LVD-naive|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
640592|NCT00423878|B3|Baseline|Total|Total of all reporting groups
640593|NCT00423878|B2|Baseline|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
640594|NCT00423878|B1|Baseline|Switch Group|Participants will switch to aripiprazole.
640595|NCT00423878|P2|Participant Flow|Stay Group|Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
640864|NCT00423358|E2|Reported Event|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
640603|NCT00423852|B1|Baseline|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
640604|NCT00423852|P1|Participant Flow|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
640605|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
640606|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
640607|NCT00423852|E1|Reported Event|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
640608|NCT00423813|B4|Baseline|Total|Total of all reporting groups
640609|NCT00423813|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
640610|NCT00423813|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
640611|NCT00423813|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
640612|NCT00423813|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
640613|NCT00423813|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
640614|NCT00423813|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
640615|NCT00423813|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
640616|NCT00423813|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
640617|NCT00423813|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
640618|NCT00423813|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
640619|NCT00423813|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
640620|NCT00423813|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
640621|NCT00423800|B3|Baseline|Total|Total of all reporting groups
640622|NCT00423800|B2|Baseline|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
640623|NCT00423800|B1|Baseline|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
640624|NCT00423800|P2|Participant Flow|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
640625|NCT00423800|P1|Participant Flow|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
640626|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
640627|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
640628|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
640629|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
640630|NCT00423800|E3|Reported Event|Pegetron® - 48 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
640631|NCT00423800|E2|Reported Event|Pegetron® - 24 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment.
640632|NCT00423800|E1|Reported Event|Screen Failures|Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here.
640633|NCT00423735|B4|Baseline|Total|Total of all reporting groups
640634|NCT00423735|B3|Baseline|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640638|NCT00423735|P2|Participant Flow|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640639|NCT00423735|P1|Participant Flow|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
640640|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640641|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
640642|NCT00423735|O2|Outcome|Progressive Disease|"Patients with best tumor response of progressive disease by six months. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
640643|NCT00423735|O1|Outcome|Stable Disease|"Patients with best response of stable disease by six months. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
640644|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640645|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
640646|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640647|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
640648|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640649|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
640650|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640651|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
640652|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640653|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
640654|NCT00423735|O3|Outcome|Stage 2:|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity
640655|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
640656|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
640657|NCT00423735|E2|Reported Event|Stage 1B: Dasatinib up to 400mg/Day|"Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.~dasatinib: Given orally"
640658|NCT00423735|E1|Reported Event|Stage 1: Dasatinib 200mg/Day|"Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity~dasatinib: Given orally"
640659|NCT00423722|B3|Baseline|Total|Total of all reporting groups
640660|NCT00423722|B2|Baseline|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640661|NCT00423722|B1|Baseline|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640662|NCT00423722|P2|Participant Flow|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640663|NCT00423722|P1|Participant Flow|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640665|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640667|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640668|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640669|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640670|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640671|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640672|NCT00423722|O2|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640673|NCT00423722|O1|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640674|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640675|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640676|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640677|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640678|NCT00423722|O2|Outcome|Placebo|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640679|NCT00423722|O1|Outcome|Hydration|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
640680|NCT00423722|E2|Reported Event|Placebo|Change Between Day 4 and Baseline
640681|NCT00423722|E1|Reported Event|Hydration|Change Between Day 4 and Baseline
640682|NCT00423683|B3|Baseline|Total|Total of all reporting groups
640683|NCT00423683|B2|Baseline|1- Arixtra Alone|Arixtra treatment without inferior vena cava filter
640684|NCT00423683|B1|Baseline|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
640685|NCT00423683|P2|Participant Flow|1-Arixtra Alone|Arixtra treatment without inferior vena cava filter
640686|NCT00423683|P1|Participant Flow|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
640687|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
640688|NCT00423683|O1|Outcome|Arm 1 Arixtra|
640689|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
640690|NCT00423683|O1|Outcome|Arm 1 Arixtra|
640691|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
640692|NCT00423683|O1|Outcome|Arm 1 Arixtra|
640693|NCT00423683|O2|Outcome|Arixtra and Filter|
640694|NCT00423683|O1|Outcome|Arixtra|
640695|NCT00423683|E2|Reported Event|Arixtra Alone|Arixtra anti coagulation alone
640696|NCT00423683|E1|Reported Event|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
640697|NCT00423670|B8|Baseline|Total|Total of all reporting groups
640698|NCT00423670|B7|Baseline|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640699|NCT00423670|B6|Baseline|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640700|NCT00423670|B5|Baseline|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640701|NCT00423670|B4|Baseline|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640702|NCT00423670|B3|Baseline|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640703|NCT00423670|B2|Baseline|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640704|NCT00423670|B1|Baseline|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640705|NCT00423670|P8|Participant Flow|Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
640706|NCT00423670|P7|Participant Flow|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640707|NCT00423670|P6|Participant Flow|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640708|NCT00423670|P5|Participant Flow|Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640709|NCT00423670|P4|Participant Flow|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640710|NCT00423670|P3|Participant Flow|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640863|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
640711|NCT00423670|P2|Participant Flow|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640712|NCT00423670|P1|Participant Flow|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640713|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640714|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640715|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640716|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640717|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640718|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640719|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640720|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640721|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640722|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640723|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640724|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640725|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640726|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640727|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640728|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640729|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640730|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640731|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640732|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640733|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640734|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640735|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640736|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640737|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640738|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640739|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640769|NCT00423657|B1|Baseline|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
640740|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640741|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640742|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640743|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640744|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640745|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640746|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640747|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640748|NCT00423670|O2|Outcome|Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 28 weeks.
640749|NCT00423670|O1|Outcome|Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 48 weeks.
640750|NCT00423670|O2|Outcome|Arm 2 and Arm 4. PEG + RBV + BOC|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640751|NCT00423670|O1|Outcome|Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640752|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640753|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640754|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640755|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640756|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640757|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640758|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
640759|NCT00423670|E8|Reported Event|PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
640760|NCT00423670|E7|Reported Event|PEG +Low-dose RBV + BOC for 48 Wks (Part II)|Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640761|NCT00423670|E6|Reported Event|PEG + RBV + BOC for 48 Wks (Part II)|Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
640762|NCT00423670|E5|Reported Event|PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
640763|NCT00423670|E4|Reported Event|PEG +RBV + BOC for 48 Wks (Part I)|Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
640764|NCT00423670|E3|Reported Event|PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
640765|NCT00423670|E2|Reported Event|PEG + RBV + BOC for 28 Wks (Part I)|Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
640766|NCT00423670|E1|Reported Event|PEG +RBV for 48 Wks (Part I)|"Arm 1. PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.~Adverse events for 36 participants after they crossed over to Arm 8 are not included."
640767|NCT00423657|B3|Baseline|Total|Total of all reporting groups
640768|NCT00423657|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
640770|NCT00423657|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
640771|NCT00423657|P1|Participant Flow|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
640772|NCT00423657|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
640773|NCT00423657|O1|Outcome|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
640774|NCT00423657|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
640775|NCT00423657|E1|Reported Event|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
640776|NCT00423605|B1|Baseline|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
640777|NCT00423605|P1|Participant Flow|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
640778|NCT00423605|O1|Outcome|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
640779|NCT00423605|E1|Reported Event|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
640780|NCT00423592|B1|Baseline|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640781|NCT00423592|P1|Participant Flow|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640782|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640783|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640784|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640785|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640786|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640787|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640788|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640789|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640790|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640791|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640792|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640793|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640794|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640795|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640796|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640797|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640798|NCT00423592|E1|Reported Event|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
640799|NCT00423579|B3|Baseline|Total|Total of all reporting groups
640800|NCT00423579|B2|Baseline|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
640801|NCT00423579|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
640802|NCT00423579|P2|Participant Flow|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
640803|NCT00423579|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
640804|NCT00423579|O2|Outcome|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
640805|NCT00423579|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
640806|NCT00423579|E2|Reported Event|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
640807|NCT00423579|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
640808|NCT00423488|B3|Baseline|Total|Total of all reporting groups
640809|NCT00423488|B2|Baseline|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640810|NCT00423488|B1|Baseline|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640811|NCT00423488|P2|Participant Flow|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640812|NCT00423488|P1|Participant Flow|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640813|NCT00423488|O2|Outcome|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640814|NCT00423488|O1|Outcome|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640815|NCT00423488|E2|Reported Event|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640816|NCT00423488|E1|Reported Event|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
640817|NCT00423449|B1|Baseline|All Participants|Vorinostat + Gemcitabine + Cisplatin
640818|NCT00423449|P5|Participant Flow|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640819|NCT00423449|P4|Participant Flow|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640820|NCT00423449|P3|Participant Flow|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640821|NCT00423449|P2|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640822|NCT00423449|P1|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640823|NCT00423449|O1|Outcome|All Participants|Vorinostat + Gemcitabine + Cisplatin
640861|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
640824|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640825|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640826|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640827|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640828|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640829|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640830|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640831|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640832|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640833|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640834|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640835|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640836|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640837|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640838|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
640839|NCT00423449|E5|Reported Event|MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
640840|NCT00423449|E4|Reported Event|MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
640841|NCT00423449|E3|Reported Event|MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
640842|NCT00423449|E2|Reported Event|MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
640843|NCT00423449|E1|Reported Event|MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin|
640844|NCT00423436|B3|Baseline|Total|Total of all reporting groups
640845|NCT00423436|B2|Baseline|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
640846|NCT00423436|B1|Baseline|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
640847|NCT00423436|P2|Participant Flow|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
640848|NCT00423436|P1|Participant Flow|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
640849|NCT00423436|O2|Outcome|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
640850|NCT00423436|O1|Outcome|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
640851|NCT00423436|E2|Reported Event|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
640852|NCT00423436|E1|Reported Event|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
640853|NCT00423358|B3|Baseline|Total|Total of all reporting groups
640854|NCT00423358|B2|Baseline|Placebo|"matching placebo tablet~placebo: matching placebo"
640855|NCT00423358|B1|Baseline|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
640856|NCT00423358|P2|Participant Flow|Placebo|"matching placebo tablet~placebo: matching placebo"
640857|NCT00423358|P1|Participant Flow|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
640858|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
640859|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
640860|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
640862|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
640865|NCT00423358|E1|Reported Event|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
640866|NCT00423332|B3|Baseline|Total|Total of all reporting groups
640867|NCT00423332|B2|Baseline|Placebo|Placebo/Day
640868|NCT00423332|B1|Baseline|AZD2171 45 mg|AZD2171 45mg/Day
640869|NCT00423332|P2|Participant Flow|Placebo|Placebo / Day: 18 patients randomised
640870|NCT00423332|P1|Participant Flow|AZD2171 45 mg|AZD2171 45mg/Day: 53 patients randomised
640871|NCT00423332|O2|Outcome|Placebo|Placebo/Day
640872|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
640873|NCT00423332|O2|Outcome|Placebo|Placebo/Day
640874|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
640875|NCT00423332|O2|Outcome|Placebo|Placebo/Day
640876|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
640877|NCT00423332|O2|Outcome|Placebo|Placebo/Day
640878|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
640879|NCT00423332|O2|Outcome|Placebo|Placebo/Day
640880|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
640881|NCT00423332|O2|Outcome|Placebo|Placebo/Day
640882|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
640883|NCT00423332|E3|Reported Event|Cediranib OL|Open Label part
640884|NCT00423332|E2|Reported Event|Placebo DB|Double Blind part
640885|NCT00423332|E1|Reported Event|Cediranib DB|Double Blind part
640886|NCT00423319|B3|Baseline|Total|Total of all reporting groups
640887|NCT00423319|B2|Baseline|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640888|NCT00423319|B1|Baseline|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640889|NCT00423319|P2|Participant Flow|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640890|NCT00423319|P1|Participant Flow|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640891|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640892|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640893|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640894|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640895|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640896|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640897|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640898|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640899|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640900|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640901|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640902|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640903|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640904|NCT00423319|O1|Outcome|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640905|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640906|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640907|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640908|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640909|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640910|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640911|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640912|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640913|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640914|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
649824|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
640915|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640916|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640917|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640918|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640919|NCT00423319|E2|Reported Event|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
640920|NCT00423319|E1|Reported Event|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
640921|NCT00423293|B1|Baseline|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
640922|NCT00423293|P1|Participant Flow|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
640923|NCT00423293|O1|Outcome|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
640924|NCT00423293|E1|Reported Event|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
640925|NCT00423267|B3|Baseline|Total|Total of all reporting groups
640926|NCT00423267|B2|Baseline|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
640927|NCT00423267|B1|Baseline|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640928|NCT00423267|P2|Participant Flow|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
640929|NCT00423267|P1|Participant Flow|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.
640930|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640931|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
640932|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640933|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640934|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640935|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
640936|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640937|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640938|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
641028|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
640939|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640940|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
640941|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
640942|NCT00423267|E3|Reported Event|Posaconazole Period B|
640943|NCT00423267|E2|Reported Event|Fluconazole Period A|
640944|NCT00423267|E1|Reported Event|Posaconazole Period A|
640945|NCT00423189|B4|Baseline|Total|Total of all reporting groups
640946|NCT00423189|B3|Baseline|Arm 3|20% fluence photodynamic therapy - procedure
640947|NCT00423189|B2|Baseline|Arm 2|40% fluence photodynamic therapy - procedure
640948|NCT00423189|B1|Baseline|Arm 1|drug - intravitreal ranibizumab
640949|NCT00423189|P3|Participant Flow|Ranibizumab and 20% Fluence PDT(Procedure)|20% fluence photodynamic therapy - procedure
640950|NCT00423189|P2|Participant Flow|Ranibizumab and 40% Fluence PDT(Procedure)|40% fluence photodynamic therapy - procedure
640951|NCT00423189|P1|Participant Flow|Ranibizumab Only|drug - intravitreal ranibizumab
640952|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab - procedure
640953|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy/combined with ranibizumab - procedure
640954|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
640955|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
640956|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
640957|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
640958|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
640959|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
640960|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
640961|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
640962|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
640963|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
640964|NCT00423189|O3|Outcome|20% Fluence PDT/Ranibizumab|20% Fluence PDT with IVT Ranibizumab
640965|NCT00423189|O2|Outcome|40% Fluence PDT/Ranibizumab|40% Fluence PDT WITH ivt Ranibizumab
640966|NCT00423189|O1|Outcome|Ranibizumab Only|IVT Ranibizumab only
640967|NCT00423189|E3|Reported Event|20% PDT Fluence Combined With Ranibizumab|Subjects who received 20% with as needed ranibizumab
640968|NCT00423189|E2|Reported Event|40% Fluence PDT Combined With Ranibizumab|Subjects who have received 40% fluence PDT combined with as needed dosing with ranibizumab
640969|NCT00423189|E1|Reported Event|Ranibizumab Only|subject only received ranibizumab
640970|NCT00423176|B3|Baseline|Total|Total of all reporting groups
640971|NCT00423176|B2|Baseline|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
640972|NCT00423176|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
640973|NCT00423176|P2|Participant Flow|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
640974|NCT00423176|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
640975|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
640976|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
640977|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
640978|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
641137|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
640979|NCT00423176|E2|Reported Event|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
640980|NCT00423176|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
640981|NCT00423150|B1|Baseline|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
640982|NCT00423150|P1|Participant Flow|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
640983|NCT00423150|O1|Outcome|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
640984|NCT00423150|E1|Reported Event|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
640985|NCT00423098|B3|Baseline|Total|Total of all reporting groups
640986|NCT00423098|B2|Baseline|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640987|NCT00423098|B1|Baseline|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640988|NCT00423098|P2|Participant Flow|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640989|NCT00423098|P1|Participant Flow|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640990|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640991|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640992|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640993|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640994|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640995|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640996|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640997|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640998|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
640999|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641000|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641001|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641002|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641003|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641004|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641005|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641006|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641007|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641008|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641009|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641010|NCT00423098|E2|Reported Event|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641179|NCT00422812|E4|Reported Event|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
641011|NCT00423098|E1|Reported Event|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
641012|NCT00423085|B4|Baseline|Total|Total of all reporting groups
641013|NCT00423085|B3|Baseline|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641014|NCT00423085|B2|Baseline|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641015|NCT00423085|B1|Baseline|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641016|NCT00423085|P4|Participant Flow|Open-label Extension|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
641017|NCT00423085|P3|Participant Flow|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641018|NCT00423085|P2|Participant Flow|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641019|NCT00423085|P1|Participant Flow|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641020|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
641021|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
641022|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
641023|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641024|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641025|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641026|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641027|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
649825|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
641029|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641030|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641031|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641032|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641033|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641034|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641035|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641036|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641037|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641038|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641039|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641040|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641041|NCT00423085|E4|Reported Event|Open-Label Extension (52 Weeks)|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
641042|NCT00423085|E3|Reported Event|Rivastigmine 10 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 patch for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641043|NCT00423085|E2|Reported Event|Rivastigmine 5 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
641044|NCT00423085|E1|Reported Event|Placebo (24 Weeks)|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
641045|NCT00423046|B3|Baseline|Total|Total of all reporting groups
641046|NCT00423046|B2|Baseline|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641047|NCT00423046|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641138|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641048|NCT00423046|P2|Participant Flow|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641049|NCT00423046|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641050|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641051|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641052|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641053|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641054|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641055|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641056|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641057|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641058|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641059|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641060|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641061|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641062|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641063|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641064|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641065|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641066|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641067|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641068|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641069|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641070|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641071|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641072|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641073|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641074|NCT00423046|O2|Outcome|Gardasil Group|Gardasil Group Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641075|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641076|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641077|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641078|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641079|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641080|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641081|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641082|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641083|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641084|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641085|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641086|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641087|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641088|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641089|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641090|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641091|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641092|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641093|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641094|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641095|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641096|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641097|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
649826|NCT00402987|O3|Outcome|Placebo|
641098|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641099|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641100|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641101|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641102|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641103|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641104|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641105|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641106|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641107|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641108|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641109|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641110|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641111|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641112|NCT00423046|E2|Reported Event|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641113|NCT00423046|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
641114|NCT00422942|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641115|NCT00422942|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or as needed (PRN) if retreatment criteria were not met; premedication with methylprednisolone (MP) 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg per week (mg/week; oral or parenteral) for up to 48 weeks and folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641116|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641117|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641118|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641119|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641120|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641121|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641122|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641123|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641124|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641125|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641126|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641127|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641128|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641129|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641130|NCT00422942|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
641131|NCT00422903|B3|Baseline|Total|Total of all reporting groups
641132|NCT00422903|B2|Baseline|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery
641133|NCT00422903|B1|Baseline|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641134|NCT00422903|P2|Participant Flow|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641135|NCT00422903|P1|Participant Flow|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641136|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641274|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
641139|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641140|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641141|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641142|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641143|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641144|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641145|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641146|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641147|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641148|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641149|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641150|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641151|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641152|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641153|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641154|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641155|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641156|NCT00422903|E2|Reported Event|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
641157|NCT00422903|E1|Reported Event|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
641158|NCT00422812|B5|Baseline|Total|Total of all reporting groups
641159|NCT00422812|B4|Baseline|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
641160|NCT00422812|B3|Baseline|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
641161|NCT00422812|B2|Baseline|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
641162|NCT00422812|B1|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
641163|NCT00422812|P4|Participant Flow|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
641164|NCT00422812|P3|Participant Flow|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
641165|NCT00422812|P2|Participant Flow|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
641166|NCT00422812|P1|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
641167|NCT00422812|O4|Outcome|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
641168|NCT00422812|O3|Outcome|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
641169|NCT00422812|O2|Outcome|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
641170|NCT00422812|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
641171|NCT00422812|O4|Outcome|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
641172|NCT00422812|O3|Outcome|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
641173|NCT00422812|O2|Outcome|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
641174|NCT00422812|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
641175|NCT00422812|O4|Outcome|Inhaled PCZ 10 mg|"Inhaled Staccato Prochlorperazine 10 mg~Inhaled PCZ 10 mg: Inhaled Staccato Prochlorperazine 10 mg"
641176|NCT00422812|O3|Outcome|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
641177|NCT00422812|O2|Outcome|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
641178|NCT00422812|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
641180|NCT00422812|E3|Reported Event|Inhaled PCZ 7.5 mg|"Inhaled Staccato Prochlorperazine 7.5 mg~Inhaled PCZ 7.5 mg: Inhaled Staccato Prochlorperazine 7.5 mg"
641181|NCT00422812|E2|Reported Event|Inhaled PCZ 5 mg|"Inhaled Staccato Prochlorperazine 5 mg~Inhaled PCZ 5 mg: Inhaled Staccato Prochlorperazine 5 mg"
641182|NCT00422812|E1|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo~Inhaled Placebo: Inhaled Staccato Placebo"
641183|NCT00422799|B1|Baseline|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
641184|NCT00422799|P1|Participant Flow|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
641185|NCT00422799|O1|Outcome|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
641186|NCT00422799|O1|Outcome|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
641187|NCT00422799|O1|Outcome|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
641188|NCT00422799|O1|Outcome|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
641189|NCT00422799|E1|Reported Event|Bortezomib and Rituximab|"bortezomib and rituximab~Bortezomib: Once weekly for 3 weeks~Rituximab: Intravenously once a week for the first and fourth weeks of a cycle"
641190|NCT00422734|B3|Baseline|Total|Total of all reporting groups
641191|NCT00422734|B2|Baseline|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641192|NCT00422734|B1|Baseline|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641193|NCT00422734|P2|Participant Flow|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641194|NCT00422734|P1|Participant Flow|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641195|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641196|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641197|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641198|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641199|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641200|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641201|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641202|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641203|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641204|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641205|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641206|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641207|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641208|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641209|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641210|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641211|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641212|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641213|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641214|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641215|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641216|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641217|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641218|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641219|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641220|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641221|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641222|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641223|NCT00422734|E2|Reported Event|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
641224|NCT00422734|E1|Reported Event|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
641225|NCT00422695|B3|Baseline|Total|Total of all reporting groups
641226|NCT00422695|B2|Baseline|Healthy Controls|HIV -ve subjects
641227|NCT00422695|B1|Baseline|HIV +|Groups divided according to CD4 counts
641228|NCT00422695|P2|Participant Flow|Healthy Controls|HIV -free subjects 38 Healthy Controls
641229|NCT00422695|P1|Participant Flow|HIV +|Groups divided according to CD4 counts 105 HIV subjects
641230|NCT00422695|O2|Outcome|Healthy Controls|HIV -free subjects 38 Healthy Controls
641231|NCT00422695|O1|Outcome|HIV +|Groups divided according to CD4 counts 105 HIV subjects
641232|NCT00422695|O2|Outcome|Healthy Controls|HIV -free subjects 38 Healthy Controls
641233|NCT00422695|O1|Outcome|HIV +|Groups divided according to CD4 counts 105 HIV subjects
641234|NCT00422695|E2|Reported Event|Healthy Controls|HIV -free subjects 38 Healthy Controls
641235|NCT00422695|E1|Reported Event|HIV +|Groups divided according to CD4 counts 105 HIV subjects
641236|NCT00422669|B4|Baseline|Total|Total of all reporting groups
641237|NCT00422669|B3|Baseline|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
641238|NCT00422669|B2|Baseline|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641239|NCT00422669|B1|Baseline|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641240|NCT00422669|P3|Participant Flow|Not Randomized|7 of the 205 subjects did not meet inclusion/exclusion criteria.
641241|NCT00422669|P2|Participant Flow|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641242|NCT00422669|P1|Participant Flow|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641243|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
641244|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641245|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641246|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
641247|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641248|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641249|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
641250|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641251|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641252|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
641253|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641254|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641255|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
641256|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641257|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641258|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
641259|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
641260|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
641261|NCT00422669|E1|Reported Event|Subjects With Implant|All 198 subjects with implant were included in this group.
641262|NCT00422656|B1|Baseline|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
641263|NCT00422656|P1|Participant Flow|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
641264|NCT00422656|O1|Outcome|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
641265|NCT00422656|O1|Outcome|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
641266|NCT00422656|O1|Outcome|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
641267|NCT00422656|O1|Outcome|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
641268|NCT00422656|E1|Reported Event|Perifosine|Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
641269|NCT00422513|B3|Baseline|Total|Total of all reporting groups
641270|NCT00422513|B2|Baseline|Epoetin Alfa|As prescribed, (iv), 3 times weekly
641271|NCT00422513|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
641272|NCT00422513|P2|Participant Flow|Epoetin Alfa|As prescribed, (iv), 3 times weekly
641273|NCT00422513|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms intravenous (iv) monthly, starting dose
641275|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
641276|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
641277|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
641278|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
641279|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
641280|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
641281|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
641282|NCT00422513|E2|Reported Event|Epoetin Alfa|As prescribed, (iv), 3 times weekly
641283|NCT00422513|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
641284|NCT00422448|B1|Baseline|Nevi|with or without BRAF and NRAS
641285|NCT00422448|P1|Participant Flow|Nevi|with or without BRAF and NRAS
641286|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
641287|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
641288|NCT00422448|E1|Reported Event|Nevi|with or without BRAF and NRAS
641289|NCT00422422|B1|Baseline|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641290|NCT00422422|P1|Participant Flow|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641291|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641292|NCT00422422|O1|Outcome|Brivaracetam (FAS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641293|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641294|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641295|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641296|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641297|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641298|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641299|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641300|NCT00422422|E1|Reported Event|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
641301|NCT00422383|B6|Baseline|Total|Total of all reporting groups
641302|NCT00422383|B5|Baseline|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641303|NCT00422383|B4|Baseline|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641304|NCT00422383|B3|Baseline|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641305|NCT00422383|B2|Baseline|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641306|NCT00422383|B1|Baseline|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641307|NCT00422383|P5|Participant Flow|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641308|NCT00422383|P4|Participant Flow|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641309|NCT00422383|P3|Participant Flow|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641310|NCT00422383|P2|Participant Flow|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641311|NCT00422383|P1|Participant Flow|Rituximab Low Dose Plus (+) Methotrexate|Participants received rituximab, 0.5 grams (g), intravenously (IV), on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 milligrams (mg), IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 milligrams per milliliter (mg/mL), orally (PO) or parenterally, as prescribed. Participants also received a stable dose of folate greater than or equal to (≥) 5 milligrams per week (mg/week) given either as a single dose or as a divided weekly dose.
641462|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641312|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641313|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641314|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641315|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641316|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641317|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641318|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641319|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641320|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641321|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641322|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641463|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641323|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641324|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641325|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641326|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641327|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641328|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641329|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641330|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641331|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641332|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641333|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641334|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641464|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641335|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641336|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641337|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641338|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641339|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641340|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641341|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641342|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641343|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641344|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641345|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641346|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641465|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641347|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641348|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641349|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641350|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641351|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641352|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641353|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641354|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641355|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641356|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641357|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641358|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641359|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641360|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641361|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641362|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641363|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641364|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641365|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641366|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641367|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641368|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641369|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641370|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641466|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641371|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641372|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641373|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641374|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641375|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641376|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641377|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641378|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641379|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641380|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641381|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641382|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641467|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641528|NCT00422162|P1|Participant Flow|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641383|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641384|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641385|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641386|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641387|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641388|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641389|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641390|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641391|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641392|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641393|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641394|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641468|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641469|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641395|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641396|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641397|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641398|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641399|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641400|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641401|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641402|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641403|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641404|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641405|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641470|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641529|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641406|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641407|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641408|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641409|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641410|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641411|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641412|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641413|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641414|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641415|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641416|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641417|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641471|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641530|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641418|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641419|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641420|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641421|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641422|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641423|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641424|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641425|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641426|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641427|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641428|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641429|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641531|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641430|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641431|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641432|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641433|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641434|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641435|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641436|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641437|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641438|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641439|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641440|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641441|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641472|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641473|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641442|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641443|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641444|NCT00422383|E5|Reported Event|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641445|NCT00422383|E4|Reported Event|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
641446|NCT00422383|E3|Reported Event|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641447|NCT00422383|E2|Reported Event|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641448|NCT00422383|E1|Reported Event|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
641449|NCT00422292|B5|Baseline|Total|Total of all reporting groups
641450|NCT00422292|B4|Baseline|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641451|NCT00422292|B3|Baseline|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641452|NCT00422292|B2|Baseline|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641453|NCT00422292|B1|Baseline|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641454|NCT00422292|P4|Participant Flow|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641455|NCT00422292|P3|Participant Flow|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641456|NCT00422292|P2|Participant Flow|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641457|NCT00422292|P1|Participant Flow|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641458|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641459|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641460|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641461|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641584|NCT00422097|B4|Baseline|Ixabepilone, 20 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 20 mg, on Days 1 through 5 every 21 days.
641474|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641475|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641476|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641477|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641478|NCT00422292|E4|Reported Event|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641479|NCT00422292|E3|Reported Event|Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
641480|NCT00422292|E2|Reported Event|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
641481|NCT00422292|E1|Reported Event|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
641482|NCT00422279|B3|Baseline|Total|Total of all reporting groups
641483|NCT00422279|B2|Baseline|Extraction Sites|bone inductive implants placed in tooth extraction sites
641484|NCT00422279|B1|Baseline|Supralveolar Position|bone inductive implants placed in supraalveolar position
641485|NCT00422279|P2|Participant Flow|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
641486|NCT00422279|P1|Participant Flow|Supraalveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
641487|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants placed in tooth extraction sockets with a total of 2 patients with 4 implants ( two implants in each patient)
641488|NCT00422279|O1|Outcome|Supraalveloar Postion|bone inductive implants placed in supraalveolar position a total of 2 patients with 4 implants ( two implants in each patient)
641489|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
641490|NCT00422279|O1|Outcome|Supra Aleveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
641491|NCT00422279|E2|Reported Event|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sites
641492|NCT00422279|E1|Reported Event|Supralveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
641493|NCT00422227|B3|Baseline|Total|Total of all reporting groups
641494|NCT00422227|B2|Baseline|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641495|NCT00422227|B1|Baseline|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641496|NCT00422227|P2|Participant Flow|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641497|NCT00422227|P1|Participant Flow|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641498|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641499|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641500|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641501|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641502|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641503|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641504|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641505|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641506|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641507|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641508|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641509|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641510|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641511|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641512|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641513|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641514|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641515|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641516|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641517|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641518|NCT00422227|E2|Reported Event|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
641519|NCT00422227|E1|Reported Event|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
641520|NCT00422201|B1|Baseline|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
641521|NCT00422201|P1|Participant Flow|Single Arm Mifepristone|"Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
641522|NCT00422201|O1|Outcome|Mifepristone|"Single arm. Study medication was administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
641523|NCT00422201|E1|Reported Event|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
641524|NCT00422162|B3|Baseline|Total|Total of all reporting groups
641525|NCT00422162|B2|Baseline|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641526|NCT00422162|B1|Baseline|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641527|NCT00422162|P2|Participant Flow|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641865|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641532|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641533|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641534|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641535|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641536|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641537|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641538|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641539|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641540|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641541|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
641542|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
641543|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
641544|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
641545|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
641546|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
641547|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
641548|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
641549|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
641550|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
641551|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
641552|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
641553|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641554|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641555|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641556|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641557|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641558|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641559|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641560|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641561|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
641562|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
641563|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
641564|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
641565|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641566|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641567|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
641568|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
641569|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
641570|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
641571|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641572|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641573|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
641574|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
641575|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
641576|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
641577|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641578|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641579|NCT00422162|E2|Reported Event|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
641580|NCT00422162|E1|Reported Event|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
641581|NCT00422097|B7|Baseline|Total|Total of all reporting groups
641582|NCT00422097|B6|Baseline|Ixabepilone, 30 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 30 mg, on Days 1 through 5 every 21 days.
641583|NCT00422097|B5|Baseline|Ixabepilone, 25 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 25 mg, on Days 1 through 5 every 21 days.
641585|NCT00422097|B3|Baseline|Ixabepilone, 15 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 15 mg, on Days 1 through 5 every 21 days.
641586|NCT00422097|B2|Baseline|Ixabepilone, 10 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 10 mg, on Days 1 through 5 every 21 days.
641587|NCT00422097|B1|Baseline|Ixabepilone, 5 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 5 mg, on Days 1 through 5 every 21 days.
641588|NCT00422097|P8|Participant Flow|Ixabepilone, MTD (25 mg), With Food|Cohort opened for Cycle 2, after ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, once daily in an oral dose on Days 1 through 5. On all dosing days in Cycle 1, participants fasted at least 4 hours before and 4 hours after dosing. Then participants crossed over to Cycle 2. On Day 1 of Cycle 2, participants allowed a low-fat meal. Participants ingest the specified meal within a 30-minute period and receive ixabepilone, 25 mg, 30 minutes after start of the meal. For the duration of Cycle 2, participants fast 1 hour before and 2 hours after ixabepilone dose.
641589|NCT00422097|P7|Participant Flow|Ixabepilone, MTD (25 mg), With Famotidine|Cohort opened for Cycle 2, once ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, alone, orally once per day on Days 1 through 21. Then participants crossed over to receive famotidine wirh ixabepilone in Cycle 2. Prior to dosing on Day 1 of Cycle 2, famotidine, 40 mg, administered in an oral dose 2 hours before ixabepilone 25-mg dose.
641590|NCT00422097|P6|Participant Flow|Ixabepilone, 30 mg/d|Ixabepilone, 30 mg, given daily orally on Days 1 through 5 every 21 days. If 2 or more of the first 3 participants experience a DLT within the first 21-day course, this dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD (the maximum dose that can be given to 6 participants without producing a DLT in more than 1 [or fewer than 1/3 if more than 6 participants in cohort)]. On all dosing days in Cycle 1, participants to fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
641591|NCT00422097|P5|Participant Flow|Ixabepilone, 25 mg/d|Ixabepilone, 25 mg/d, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT in the first 21-day course, a new cohort is opened at the next dose level (30 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD. The MTD is the maximum dose that can be given to 6 participants without producing a DLT in more than 1 participant (or fewer than 1/3 if the cohort has more than 6 participants). More participants may be enrolled at any level to provide additional safety data. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
641592|NCT00422097|P4|Participant Flow|Ixabepilone, 20 mg/d|Ixabepilone, 20 mg, given daily in oral doses on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (25 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
641593|NCT00422097|P3|Participant Flow|Ixabepilone, 15 mg/d|Ixabepilone, 15 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (20 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
641594|NCT00422097|P2|Participant Flow|Ixabepilone, 10 mg/d|Ixabepilone, 10 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (15 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
641595|NCT00422097|P1|Participant Flow|Ixabepilone, 5 mg/d|Ixabepilone, 5 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a dose-limiting toxicity (DLT) in the first 21-day course, a new cohort is opened at the next dose level (10 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
641596|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641597|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641598|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641599|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641600|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641601|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641602|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641603|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants who received MTD (25 mg) ixabepilone without famotidine and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine. Fasted/Fed criteria: Cycle 1: Dose 1 administered after a minimum of a 4-hour fast. Cycle 2: Dose 1 administered with a low-fat meal to crossover cohort.
641604|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone (with famotidine (Cycle 2). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after ixabepilone treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
641605|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
641606|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
641607|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
641608|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
641609|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641610|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641611|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641612|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641613|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641614|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641615|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641616|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641617|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641618|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641619|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641620|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641621|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641622|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641623|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641624|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
649827|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
641625|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641626|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641627|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
641628|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
641629|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
641630|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
641631|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
641632|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
641633|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641634|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641635|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641636|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641637|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641638|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641639|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641640|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641641|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641642|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641643|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641644|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641645|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641646|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
641647|NCT00422097|E6|Reported Event|Ixabepilone, 30 mg|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days
641648|NCT00422097|E5|Reported Event|Ixabepilone, 25 mg|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days
641649|NCT00422097|E4|Reported Event|Ixabepilone, 20 mg|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days
641650|NCT00422097|E3|Reported Event|Ixabepilone, 15 mg|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days
641651|NCT00422097|E2|Reported Event|Ixabepilone, 10 mg|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days
641857|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641652|NCT00422097|E1|Reported Event|Ixabepilone, 5 mg|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days
641653|NCT00422058|B7|Baseline|Total|Total of all reporting groups
641654|NCT00422058|B6|Baseline|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641655|NCT00422058|B5|Baseline|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641656|NCT00422058|B4|Baseline|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641657|NCT00422058|B3|Baseline|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641658|NCT00422058|B2|Baseline|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641659|NCT00422058|B1|Baseline|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641660|NCT00422058|P6|Participant Flow|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641661|NCT00422058|P5|Participant Flow|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641662|NCT00422058|P4|Participant Flow|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641663|NCT00422058|P3|Participant Flow|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641664|NCT00422058|P2|Participant Flow|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641665|NCT00422058|P1|Participant Flow|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641666|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641667|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641668|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641669|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641670|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641671|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641672|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641673|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641674|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641675|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641858|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
641859|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641676|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641677|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641678|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641679|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641680|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641681|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641682|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641683|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641684|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641685|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641686|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641687|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641688|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641689|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641690|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641691|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641692|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641693|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641694|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641695|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641696|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641697|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641698|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641860|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641699|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641700|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641701|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641702|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641703|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641704|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641705|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641706|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641707|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641708|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641709|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641710|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641711|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641712|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641713|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641714|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641715|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641716|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641717|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641718|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641719|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641720|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641721|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641861|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
641722|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641723|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641724|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641725|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641726|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641727|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641728|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641729|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641730|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641731|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641732|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641733|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641734|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641735|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641736|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641737|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641738|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641739|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641740|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641741|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641742|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641743|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641744|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641862|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641745|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641746|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641747|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641748|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641749|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641750|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641751|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641752|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641753|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641754|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641755|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641756|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641757|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641758|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641759|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641760|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641761|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641762|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641763|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641764|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641765|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641766|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641767|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641863|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641768|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641769|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641770|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641771|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641772|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641773|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641774|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641775|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641776|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641777|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641778|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641779|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641780|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641781|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641782|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641783|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641784|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641785|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641786|NCT00422058|E6|Reported Event|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
641787|NCT00422058|E5|Reported Event|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641788|NCT00422058|E4|Reported Event|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641789|NCT00422058|E3|Reported Event|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641790|NCT00422058|E2|Reported Event|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641864|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
641791|NCT00422058|E1|Reported Event|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
641792|NCT00422032|B3|Baseline|Total|Total of all reporting groups
641793|NCT00422032|B2|Baseline|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
641794|NCT00422032|B1|Baseline|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
641795|NCT00422032|P2|Participant Flow|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
641796|NCT00422032|P1|Participant Flow|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
641797|NCT00422032|O2|Outcome|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
641798|NCT00422032|O1|Outcome|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
641799|NCT00422032|E2|Reported Event|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
641800|NCT00422032|E1|Reported Event|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
641801|NCT00421993|B5|Baseline|Total|Total of all reporting groups
641802|NCT00421993|B4|Baseline|Gel Vehicle|Topical Gel Vehicle
641803|NCT00421993|B3|Baseline|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641804|NCT00421993|B2|Baseline|Adapalene Gel|Adapalene Topical Gel
641805|NCT00421993|B1|Baseline|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641806|NCT00421993|P4|Participant Flow|Gel Vehicle|Topical Gel Vehicle
641807|NCT00421993|P3|Participant Flow|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641808|NCT00421993|P2|Participant Flow|Adapalene Gel|Adapalene Topical Gel
641809|NCT00421993|P1|Participant Flow|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641810|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
641811|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641812|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
641813|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641814|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
641815|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641816|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
641817|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641818|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
641819|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641820|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
641821|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641822|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
641823|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641824|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
641825|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641826|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
641827|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641828|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
641829|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641830|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
641831|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641832|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
641833|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641834|NCT00421993|E4|Reported Event|Gel Vehicle|Topical Gel Vehicle
641835|NCT00421993|E3|Reported Event|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
641836|NCT00421993|E2|Reported Event|Adapalene Gel|Adapalene Topical Gel
641837|NCT00421993|E1|Reported Event|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
641838|NCT00421954|B1|Baseline|Ziprasidone|Ziprasidone: subjects will use ziprasidone
641839|NCT00421954|P1|Participant Flow|Ziprasidone|Ziprasidone: subjects will use ziprasidone
641840|NCT00421954|O1|Outcome|Ziprasidone|Ziprasidone: subjects will use ziprasidone
641841|NCT00421954|E1|Reported Event|Ziprasidone|Ziprasidone: subjects will use ziprasidone
641842|NCT00421928|B4|Baseline|Total|Total of all reporting groups
641843|NCT00421928|B3|Baseline|Placebo|Matching Placebo twice daily (BID)
641844|NCT00421928|B2|Baseline|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641845|NCT00421928|B1|Baseline|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641846|NCT00421928|P3|Participant Flow|Placebo|Matching Placebo twice daily (BID)
641847|NCT00421928|P2|Participant Flow|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641848|NCT00421928|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641849|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
641850|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641851|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641852|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
641853|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641854|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641855|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
641856|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641866|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641867|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
641868|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641869|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641870|NCT00421928|E3|Reported Event|Placebo|Matching Placebo twice daily (BID)
641871|NCT00421928|E2|Reported Event|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
641872|NCT00421928|E1|Reported Event|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
641873|NCT00421889|B10|Baseline|Total|Total of all reporting groups
641874|NCT00421889|B9|Baseline|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
641875|NCT00421889|B8|Baseline|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641876|NCT00421889|B7|Baseline|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641877|NCT00421889|B6|Baseline|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641878|NCT00421889|B5|Baseline|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641879|NCT00421889|B4|Baseline|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641880|NCT00421889|B3|Baseline|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641881|NCT00421889|B2|Baseline|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641882|NCT00421889|B1|Baseline|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641883|NCT00421889|P9|Participant Flow|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
641884|NCT00421889|P8|Participant Flow|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641885|NCT00421889|P7|Participant Flow|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641886|NCT00421889|P6|Participant Flow|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641887|NCT00421889|P5|Participant Flow|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641888|NCT00421889|P4|Participant Flow|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641889|NCT00421889|P3|Participant Flow|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641890|NCT00421889|P2|Participant Flow|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641891|NCT00421889|P1|Participant Flow|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 (area under the curve) administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
642008|NCT00421408|B2|Baseline|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
641892|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
641893|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
641894|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
641895|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
641896|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
641897|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
641898|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
641899|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
641900|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
641901|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
641902|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
641903|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
641904|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
641905|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
641906|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
641907|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
641908|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
641909|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641910|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641911|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
641912|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641913|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641914|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
641915|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641916|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641917|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
641918|NCT00421889|O9|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
641919|NCT00421889|O8|Outcome|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641920|NCT00421889|O7|Outcome|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641921|NCT00421889|O6|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
642009|NCT00421408|B1|Baseline|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
641922|NCT00421889|O5|Outcome|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641923|NCT00421889|O4|Outcome|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641924|NCT00421889|O3|Outcome|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641925|NCT00421889|O2|Outcome|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641926|NCT00421889|O1|Outcome|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641927|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
641928|NCT00421889|E4|Reported Event|Part D: Bladder Cancer MTD (N=15)|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
641929|NCT00421889|E3|Reported Event|Part C: 3-6 Hours Infusion (N=7)|PXD: 1000 mg/m² was administered as a 3 or 6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
641930|NCT00421889|E2|Reported Event|Part B: Ovarian Cancer MTD (N=35)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641931|NCT00421889|E1|Reported Event|Part A: Dose Escalation (N=23)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
641932|NCT00421733|B4|Baseline|Total|Total of all reporting groups
641933|NCT00421733|B3|Baseline|Placebo|Two placebo capsules per dose
641934|NCT00421733|B2|Baseline|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
641935|NCT00421733|B1|Baseline|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
641936|NCT00421733|P3|Participant Flow|Placebo|Two placebo capsules per dose
641937|NCT00421733|P2|Participant Flow|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
641938|NCT00421733|P1|Participant Flow|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
641939|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
641940|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
641941|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
641942|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
641943|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
641944|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
641945|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
641946|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
641947|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
641948|NCT00421733|O4|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
641949|NCT00421733|O3|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
641950|NCT00421733|O2|Outcome|Combined Paricalcitol 1 Mcg and 2 Mcg|Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).
641951|NCT00421733|O1|Outcome|Placebo|Two placebo capsules per dose (N=88)
641952|NCT00421733|E3|Reported Event|Placebo|Two placebo capsules per dose
641953|NCT00421733|E2|Reported Event|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
641954|NCT00421733|E1|Reported Event|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
641955|NCT00421707|B3|Baseline|Total|Total of all reporting groups
641956|NCT00421707|B2|Baseline|Sequence B/X/A|As per the treatment sequence B/X/A, during period 1, eligible participants received matching placebo (B) once daily for 6 weeks followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641970|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
642067|NCT00420992|P1|Participant Flow|ALO-01|
642068|NCT00420992|O2|Outcome|Placebo|
641957|NCT00421707|B1|Baseline|Sequence A/X/B|As per the treatment sequence A/X/B, during period 1, eligible participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks, followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received matching placebo (B) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose pharmacokinetic (PK) blood sample.
641958|NCT00421707|P2|Participant Flow|Sequence B/X/A|As per the treatment sequence B/X/A, during period 1, eligible participants received matching placebo (B) once daily for 6 weeks followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received GW876008 125 mg (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641959|NCT00421707|P1|Participant Flow|Sequence A/X/B|As per the treatment sequence A/X/B, during period 1, eligible participants received GW876008 125 milligram (mg) (A) (1 x GW876008 100 mg and 1 x GW876008 25 mg ) once daily for 6 weeks, followed by a washout period (X) of 3 weeks where participants received matching placebo once daily followed by period 2 where participants received matching placebo (B) once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg (specific for that dispensing period) orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose pharmacokinetic (PK) blood sample.
641960|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641961|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641962|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641963|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641964|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641965|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641966|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641967|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641968|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641969|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
642069|NCT00420992|O1|Outcome|ALO-01|
641971|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641972|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641973|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641974|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641975|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641976|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641977|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641978|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641979|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641980|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641981|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641982|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641983|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641984|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641985|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
642070|NCT00420992|E3|Reported Event|Titration ALO-01|Open-label ALO-01
641986|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641987|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641988|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641989|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641990|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641991|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641992|NCT00421707|O3|Outcome|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641993|NCT00421707|O2|Outcome|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641994|NCT00421707|O1|Outcome|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641995|NCT00421707|E3|Reported Event|Placebo Washout|Eligible participants received washout placebo orally once daily for 3 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641996|NCT00421707|E2|Reported Event|Placebo|Eligible participants received matching placebo orally once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641997|NCT00421707|E1|Reported Event|GW876008 125 mg|Eligible participants received GW876008 125 mg once daily for 6 weeks. Participants were instructed to take 1 tablet from each of the 2 bottles; 25 mg and 100 mg orally in the morning with food. At the day of the Weeks 3, 6, 9, 12 and 15 Visit, participants were instructed not take their dose prior to their visit which was scheduled for the morning, they were instructed to take their dose at the site after collection of a pre-dose PK blood sample.
641998|NCT00421603|B3|Baseline|Total|Total of all reporting groups
641999|NCT00421603|B2|Baseline|Placebo|Placebo daily dose
642000|NCT00421603|B1|Baseline|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
642001|NCT00421603|P2|Participant Flow|Placebo|Placebo daily dose
642002|NCT00421603|P1|Participant Flow|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
642003|NCT00421603|O2|Outcome|Placebo|Placebo daily dose
642004|NCT00421603|O1|Outcome|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
642005|NCT00421603|E2|Reported Event|Placebo|Placebo daily dose
642006|NCT00421603|E1|Reported Event|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
642007|NCT00421408|B3|Baseline|Total|Total of all reporting groups
642071|NCT00420992|E2|Reported Event|Placebo|
642010|NCT00421408|P2|Participant Flow|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642011|NCT00421408|P1|Participant Flow|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642012|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642013|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642014|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642015|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642016|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642017|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642018|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642019|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642020|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642021|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642022|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642023|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642024|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
642025|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
642026|NCT00421408|E2|Reported Event|Protein Powder 40 g Daily|
642027|NCT00421408|E1|Reported Event|Placebo Carbohydrate Powder 40 g Daily|
642028|NCT00421343|B1|Baseline|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
642029|NCT00421343|P1|Participant Flow|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
642030|NCT00421343|O1|Outcome|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
642031|NCT00421343|E1|Reported Event|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
642032|NCT00421174|B3|Baseline|Total|Total of all reporting groups
642033|NCT00421174|B2|Baseline|Placebo|Placebo plus Corticosteroids
642034|NCT00421174|B1|Baseline|Etanercept|Etanercept plus corticosteroids
642035|NCT00421174|P2|Participant Flow|Placebo|Placebo plus Corticosteroids
642036|NCT00421174|P1|Participant Flow|Etanercept|Etanercept plus corticosteroids
642037|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642038|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642039|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642040|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642041|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642042|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642043|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642044|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642045|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642046|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642047|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642048|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642049|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642050|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642051|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642052|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642053|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642054|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642055|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642056|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642057|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642058|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642059|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
642060|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
642061|NCT00421174|E2|Reported Event|Placebo|Placebo plus Corticosteroids
642062|NCT00421174|E1|Reported Event|Etanercept|Etanercept plus corticosteroids
642063|NCT00420992|B3|Baseline|Total|Total of all reporting groups
642064|NCT00420992|B2|Baseline|Placebo|
642065|NCT00420992|B1|Baseline|ALO-01|
642066|NCT00420992|P2|Participant Flow|Placebo|
642074|NCT00420927|B7|Baseline|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642075|NCT00420927|B6|Baseline|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642076|NCT00420927|B5|Baseline|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642077|NCT00420927|B4|Baseline|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642078|NCT00420927|B3|Baseline|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642079|NCT00420927|B2|Baseline|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo(PBO) during Period 1
642080|NCT00420927|B1|Baseline|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
642081|NCT00420927|P7|Participant Flow|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642082|NCT00420927|P6|Participant Flow|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642083|NCT00420927|P5|Participant Flow|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642084|NCT00420927|P4|Participant Flow|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642085|NCT00420927|P3|Participant Flow|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642086|NCT00420927|P2|Participant Flow|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo during Period 1
642087|NCT00420927|P1|Participant Flow|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
642088|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642089|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642090|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642091|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642092|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642093|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642094|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642095|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642096|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642097|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642098|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642099|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642100|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642101|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642102|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642103|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642104|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642105|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642106|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642107|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642108|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642109|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642110|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642111|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642557|NCT00420238|B1|Baseline|Etanercept|50 mg subcutaneously (SC), once weekly
642112|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642113|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642114|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642115|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642116|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642117|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642118|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642119|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642120|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642121|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642122|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642123|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642124|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642125|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642126|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642127|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642128|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642129|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642130|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642131|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642132|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642133|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642134|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642135|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642136|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642137|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642138|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642139|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642140|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642141|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642142|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642143|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642144|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642145|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642146|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642147|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642148|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
649828|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
642149|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642150|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642151|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642152|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642153|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642154|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642155|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642156|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642157|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642158|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642159|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642160|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642161|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642162|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642163|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642164|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642165|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642166|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642167|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642168|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642169|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642170|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642171|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642172|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642173|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642174|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642175|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642176|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642177|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642178|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
642179|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
642180|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
642181|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
642182|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
642183|NCT00420927|E7|Reported Event|Period 1 PBO+MTX|Combination therapy with methotrexate (MTX) and blinded placebo (PBO) during Period 1
642184|NCT00420927|E6|Reported Event|Period 1 ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
642185|NCT00420927|E5|Reported Event|PBO+MTX/OL ADA+MTX (Arm 5)|Blinded MTX monotherapy during Period 1, open-label combination therapy during Period 2
642186|NCT00420927|E4|Reported Event|PBO+MTX/PBO+MTX (Arm 4)|Blinded MTX monotherapy during Period 1 and Period 2
643201|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
642187|NCT00420927|E3|Reported Event|ADA+MTX/OL ADA+MTX (Arm 3)|Blinded combination therapy during Period 1, open-label combination therapy during Period 2
642188|NCT00420927|E2|Reported Event|ADA+MTX/ADA+MTX (Arm 2)|Blinded combination ADA+MTX therapy during Period 1 and Period 2
642189|NCT00420927|E1|Reported Event|ADA+MTX/PBO+MTX (Arm 1)|Blinded combination ADA+MTX therapy during Period 1 and blinded MTX monotherapy during Period 2
642190|NCT00420849|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642191|NCT00420849|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642192|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642193|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642194|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642195|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642196|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642197|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642198|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642199|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642200|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642201|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642202|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642399|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642203|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642204|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642205|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642206|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642207|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642208|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642209|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642210|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642211|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642212|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642213|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642214|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642215|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642258|NCT00420784|B2|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
649829|NCT00402987|O4|Outcome|Placebo|
642216|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642217|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642218|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642219|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642220|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642221|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642222|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642223|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642224|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642225|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642226|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642227|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642228|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642277|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
643203|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
642229|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642230|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642231|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642232|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642233|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642234|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642235|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642236|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642237|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642238|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642239|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642240|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642241|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642278|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642400|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
649830|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
642242|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642243|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642244|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642245|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642246|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
642247|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
642248|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
642249|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642250|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642251|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642252|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642253|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642254|NCT00420849|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
642255|NCT00420784|B5|Baseline|Total|Total of all reporting groups
642256|NCT00420784|B4|Baseline|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642257|NCT00420784|B3|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642307|NCT00420745|E1|Reported Event|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642308|NCT00420641|B4|Baseline|Total|Total of all reporting groups
642259|NCT00420784|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642260|NCT00420784|P4|Participant Flow|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642261|NCT00420784|P3|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642262|NCT00420784|P2|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642263|NCT00420784|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642264|NCT00420784|O1|Outcome|Telaprevir|"All subjects who received single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week reporting group and for 24 weeks in Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week reporting groups."
642265|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642266|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642267|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642268|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642269|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642270|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642271|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642272|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642273|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642274|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642275|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642276|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642279|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642280|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642281|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642282|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642283|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642284|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642285|NCT00420784|E4|Reported Event|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642286|NCT00420784|E3|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
642287|NCT00420784|E2|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
642288|NCT00420784|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
642289|NCT00420745|B3|Baseline|Total|Total of all reporting groups
642290|NCT00420745|B2|Baseline|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642291|NCT00420745|B1|Baseline|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642292|NCT00420745|P2|Participant Flow|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642293|NCT00420745|P1|Participant Flow|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642294|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642295|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642296|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642297|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642298|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642299|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642300|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642301|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642302|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642303|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642304|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642305|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642306|NCT00420745|E2|Reported Event|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
642450|NCT00420407|O2|Outcome|Vasopressin|Administration of Vasopressin as the intervention
642309|NCT00420641|B3|Baseline|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642310|NCT00420641|B2|Baseline|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642311|NCT00420641|B1|Baseline|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642312|NCT00420641|P3|Participant Flow|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642313|NCT00420641|P2|Participant Flow|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642314|NCT00420641|P1|Participant Flow|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in Montgomery-Asberg Depression Rating Scale [MADRS] total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642315|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642316|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642317|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642318|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642319|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642320|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642321|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642322|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642323|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642324|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642451|NCT00420407|O1|Outcome|Normal Saline|Administration of Normal Saline as a placebo
642325|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642326|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642327|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642328|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642329|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642330|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642331|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642332|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
649831|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
642333|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642334|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642335|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642336|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642337|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642338|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642339|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642340|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642558|NCT00420238|P2|Participant Flow|Placebo/Etanercept|Placebo subcutaneously (SC), once weekly; Etanercept 50 mg SC, once weekly
642341|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642342|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642343|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642344|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642345|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642346|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642347|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642348|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642559|NCT00420238|P1|Participant Flow|Etanercept/Etanercept|Etanercept 50 mg subcutaneously (SC) once weekly
642349|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642350|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642351|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642352|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642353|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642354|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642355|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642356|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
649832|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
642357|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642358|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642359|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642360|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642361|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642362|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642363|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642364|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642611|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642365|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642366|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642367|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642368|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642369|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642370|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642371|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642372|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642807|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642373|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642374|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642375|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642376|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642377|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642378|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642379|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642380|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
649833|NCT00402987|O3|Outcome|Placebo|
642381|NCT00420641|O3|Outcome|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642382|NCT00420641|O2|Outcome|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642383|NCT00420641|O1|Outcome|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642384|NCT00420641|E3|Reported Event|Paroxetine|Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642385|NCT00420641|E2|Reported Event|GSK372475|Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642386|NCT00420641|E1|Reported Event|Placebo|Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator’s judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization.
642387|NCT00420628|B3|Baseline|Total|Total of all reporting groups
642388|NCT00420628|B2|Baseline|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
642389|NCT00420628|B1|Baseline|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642390|NCT00420628|P2|Participant Flow|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
642391|NCT00420628|P1|Participant Flow|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642392|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
642393|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642394|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
642395|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642396|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
642397|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642398|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
642808|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642401|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642402|NCT00420628|E2|Reported Event|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
642403|NCT00420628|E1|Reported Event|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
642404|NCT00420511|B3|Baseline|Total|Total of all reporting groups
642405|NCT00420511|B2|Baseline|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
642406|NCT00420511|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
642407|NCT00420511|P2|Participant Flow|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
642408|NCT00420511|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
642409|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
642410|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
642411|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
642412|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
642413|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (orally administered)
642414|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (orally administered)
642415|NCT00420511|E2|Reported Event|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
642416|NCT00420511|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
642417|NCT00420459|B1|Baseline|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
642418|NCT00420459|P1|Participant Flow|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
642419|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
642420|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
642421|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
642422|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
642423|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
642424|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole. Mean final dose was 9.8 mg/day
642425|NCT00420459|E1|Reported Event|Aripiprazole|
642426|NCT00420420|B3|Baseline|Total|Total of all reporting groups
642427|NCT00420420|B2|Baseline|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642428|NCT00420420|B1|Baseline|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642429|NCT00420420|P2|Participant Flow|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642430|NCT00420420|P1|Participant Flow|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642431|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642432|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642433|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642434|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642435|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642436|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642437|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642438|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642439|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642440|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642441|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642442|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642443|NCT00420420|E2|Reported Event|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
642444|NCT00420420|E1|Reported Event|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
642445|NCT00420407|B3|Baseline|Total|Total of all reporting groups
642446|NCT00420407|B2|Baseline|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
642447|NCT00420407|B1|Baseline|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
642448|NCT00420407|P2|Participant Flow|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
642449|NCT00420407|P1|Participant Flow|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
649834|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
642452|NCT00420407|E2|Reported Event|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
642453|NCT00420407|E1|Reported Event|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
642454|NCT00420342|B4|Baseline|Total|Total of all reporting groups
642455|NCT00420342|B3|Baseline|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642456|NCT00420342|B2|Baseline|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642457|NCT00420342|B1|Baseline|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642458|NCT00420342|P3|Participant Flow|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642459|NCT00420342|P2|Participant Flow|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642460|NCT00420342|P1|Participant Flow|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642461|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642462|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642463|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642464|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642465|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642466|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642467|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642468|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642469|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642470|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642471|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642472|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642473|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642474|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642475|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642476|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642477|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642478|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642479|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642480|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642481|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642482|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642483|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642484|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642485|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642486|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642487|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642488|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
644291|NCT00414726|B2|Baseline|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
642489|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642490|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642491|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642492|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642493|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642494|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642495|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642496|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642497|NCT00420342|E3|Reported Event|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642498|NCT00420342|E2|Reported Event|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642499|NCT00420342|E1|Reported Event|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
642500|NCT00420316|B3|Baseline|Total|Total of all reporting groups
642501|NCT00420316|B2|Baseline|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642502|NCT00420316|B1|Baseline|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642503|NCT00420316|P2|Participant Flow|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642504|NCT00420316|P1|Participant Flow|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642505|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642506|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642507|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642508|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642509|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642510|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642511|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642512|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642513|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642514|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642554|NCT00420290|E1|Reported Event|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642515|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642516|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642517|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642518|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642519|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642520|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642521|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642522|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642523|NCT00420316|E2|Reported Event|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642524|NCT00420316|E1|Reported Event|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
642525|NCT00420303|B3|Baseline|Total|Total of all reporting groups
642526|NCT00420303|B2|Baseline|Placebo|Subcutaneously once weekly
642527|NCT00420303|B1|Baseline|Etanercept|50mg subcutaneously once weekly
642528|NCT00420303|P2|Participant Flow|Placebo|Subcutaneously once weekly
642529|NCT00420303|P1|Participant Flow|Etanercept|50mg subcutaneously once weekly
642530|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
642531|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
642532|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
642533|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
642534|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
642535|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
642536|NCT00420303|E2|Reported Event|Placebo|Subcutaneously once weekly
642537|NCT00420303|E1|Reported Event|Etanercept|50mg subcutaneously once weekly
642538|NCT00420290|B3|Baseline|Total|Total of all reporting groups
642539|NCT00420290|B2|Baseline|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642540|NCT00420290|B1|Baseline|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642541|NCT00420290|P2|Participant Flow|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642542|NCT00420290|P1|Participant Flow|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642543|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642544|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642545|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642546|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642547|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642548|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642549|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642550|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642551|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642552|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642553|NCT00420290|E2|Reported Event|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
642555|NCT00420238|B3|Baseline|Total|Total of all reporting groups
642560|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642561|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642562|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642563|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642564|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642565|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642566|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642567|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642568|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642569|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642570|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642571|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642572|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642573|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642574|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642575|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642576|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642577|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642578|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642579|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642580|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642581|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642582|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642583|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642584|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642585|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642586|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642587|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642588|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642589|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642590|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642591|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642592|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642593|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642594|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642595|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642596|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642597|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642598|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642599|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642600|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642601|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642602|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642603|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642604|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642605|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642606|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642607|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642608|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642609|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642610|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642612|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642613|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642614|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642615|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642616|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642617|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642618|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642619|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642620|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642621|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642622|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642623|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642624|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642625|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642626|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642627|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642628|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642629|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642630|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
642631|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642632|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642633|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642634|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642635|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642636|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642637|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642638|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642639|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642640|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642641|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642642|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642643|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642644|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642645|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642646|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642647|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642648|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642649|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642650|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642651|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642652|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642653|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642654|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642655|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642656|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642657|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642658|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642659|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642660|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642661|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642662|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642663|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642664|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
642665|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642666|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642667|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642668|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642669|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642670|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
642671|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642672|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642673|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642674|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
642675|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642676|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642677|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642678|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
642679|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642680|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642681|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642682|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
642683|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: etanercept 50 mg subcutaneously (SC), once weekly
642684|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642685|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642686|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642687|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642688|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
642689|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
642690|NCT00420238|E4|Reported Event|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
642691|NCT00420238|E3|Reported Event|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
642692|NCT00420238|E2|Reported Event|Placebo|Double-blind Period 1: placebo subcutaneously (SC), once weekly
642693|NCT00420238|E1|Reported Event|Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly
642694|NCT00420212|B4|Baseline|Total|Total of all reporting groups
642695|NCT00420212|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642696|NCT00420212|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642697|NCT00420212|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
642698|NCT00420212|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642699|NCT00420212|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642700|NCT00420212|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
642701|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642702|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642703|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
642704|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642705|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642706|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
642707|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642708|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642709|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
642710|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642711|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642712|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
642713|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642714|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642715|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
642716|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642717|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642718|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
642719|NCT00420212|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
642720|NCT00420212|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
642721|NCT00420212|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
642722|NCT00420212|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
642723|NCT00420199|B3|Baseline|Total|Total of all reporting groups
642724|NCT00420199|B2|Baseline|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
642725|NCT00420199|B1|Baseline|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
642726|NCT00420199|P2|Participant Flow|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
642727|NCT00420199|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered intravenously (IV) on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
642728|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642729|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642730|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642731|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
642732|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642733|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642734|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642735|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642736|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642737|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642738|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642739|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642740|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642741|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642742|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642743|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642744|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642745|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642746|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642747|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642748|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642749|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642750|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642751|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642752|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642753|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642754|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642755|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642756|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642757|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642758|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642759|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642760|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642761|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642762|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642763|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642764|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642765|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642766|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642767|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642768|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642769|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
642770|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642771|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642772|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642773|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
642774|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642775|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
642776|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
642777|NCT00420199|E2|Reported Event|PLA + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
642778|NCT00420199|E1|Reported Event|ABA + MTX|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
642779|NCT00420147|B3|Baseline|Total|Total of all reporting groups
642780|NCT00420147|B2|Baseline|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a wedged in-shoe orthosis as their treatment.
642781|NCT00420147|B1|Baseline|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a neutral (non-wedged) in-shoe orthosis as their treatment.
642782|NCT00420147|P2|Participant Flow|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a laterally wedged in shoe orthosis
642783|NCT00420147|P1|Participant Flow|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a neutral in shoe orthosis
642784|NCT00420147|O2|Outcome|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis
642785|NCT00420147|O1|Outcome|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis
642786|NCT00420147|O2|Outcome|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis
642787|NCT00420147|O1|Outcome|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis
642788|NCT00420147|E2|Reported Event|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a laterally wedged in-shoe orthosis.
642789|NCT00420147|E1|Reported Event|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a neutral in-shoe orthosis.
642790|NCT00420095|B3|Baseline|Total|Total of all reporting groups
642791|NCT00420095|B2|Baseline|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
642792|NCT00420095|B1|Baseline|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
642793|NCT00420095|P2|Participant Flow|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
642794|NCT00420095|P1|Participant Flow|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
642795|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642796|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642797|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642798|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642799|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642800|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642801|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642802|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642803|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642804|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642805|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642806|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642809|NCT00420095|E2|Reported Event|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642810|NCT00420095|E1|Reported Event|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
642811|NCT00420056|B1|Baseline|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642812|NCT00420056|P1|Participant Flow|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642813|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642814|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642815|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642816|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642817|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642818|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642819|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642820|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642821|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642822|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642823|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642824|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642825|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642866|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
644292|NCT00414726|B1|Baseline|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
642826|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642827|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642828|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642829|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642830|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642831|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642832|NCT00420056|E1|Reported Event|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
642833|NCT00420017|B3|Baseline|Total|Total of all reporting groups
642834|NCT00420017|B2|Baseline|Control|Control usual care
642835|NCT00420017|B1|Baseline|Amiodarone|Intravenous amiodarone
642836|NCT00420017|P2|Participant Flow|Control|Control usual care
642837|NCT00420017|P1|Participant Flow|Amiodarone|Intravenous amiodarone
642838|NCT00420017|O2|Outcome|Control|Control usual care
642839|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
642840|NCT00420017|O2|Outcome|Control|Control usual care
642841|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
642842|NCT00420017|O2|Outcome|Control|Control usual care
642843|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
642844|NCT00420017|O2|Outcome|Control|Control usual care
642845|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
642846|NCT00420017|E2|Reported Event|Control|Control usual care
642847|NCT00420017|E1|Reported Event|Amiodarone|Intravenous amiodarone
642848|NCT00420004|B4|Baseline|Total|Total of all reporting groups
642849|NCT00420004|B3|Baseline|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642850|NCT00420004|B2|Baseline|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642851|NCT00420004|B1|Baseline|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642852|NCT00420004|P3|Participant Flow|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642853|NCT00420004|P2|Participant Flow|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642854|NCT00420004|P1|Participant Flow|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642855|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642856|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642857|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642858|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642859|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642860|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642861|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642862|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642863|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642864|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642865|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642867|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642868|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642869|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642870|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642871|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642872|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642873|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks.
642874|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642875|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642876|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642877|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642878|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642879|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642880|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642881|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642882|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642883|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642884|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642885|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642886|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642887|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642888|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642889|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642890|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642891|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642892|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642893|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642894|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642895|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642896|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642897|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642898|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642899|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642900|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642901|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642902|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642903|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642904|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642905|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642906|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642907|NCT00420004|O3|Outcome|Escitalopram|Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
642908|NCT00420004|O2|Outcome|Placebo|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
642909|NCT00420004|O1|Outcome|LY2216684|LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
642910|NCT00420004|E6|Reported Event|Escitalopram Discontinuation Phase|Included all randomized participants who discontinued escitalopram treatment
644293|NCT00414726|P2|Participant Flow|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
642911|NCT00420004|E5|Reported Event|Placebo Discontinuation Phase|Included all randomized participants who discontinued placebo
642912|NCT00420004|E4|Reported Event|LY2216684 Discontinuation Phase|Included all randomized participants who discontinued LY2216684 treatment
642913|NCT00420004|E3|Reported Event|Escitalopram Double Blind Phase|Escitalopram: 10 or 20 mg capsules, administered orally with flexible dosing, once daily for 8 weeks
642914|NCT00420004|E2|Reported Event|Placebo Double Blind Phase|Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally once daily for 8 weeks
642915|NCT00420004|E1|Reported Event|LY2216684 Double Blind Phase|LY2216684: 3, 6, 9, or 12 milligrams (mg) tablets, administered orally with flexible dosing, once daily for 8 weeks
642916|NCT00419952|B3|Baseline|Total|Total of all reporting groups
642917|NCT00419952|B2|Baseline|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642918|NCT00419952|B1|Baseline|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642919|NCT00419952|P2|Participant Flow|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642920|NCT00419952|P1|Participant Flow|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642921|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642922|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642923|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642924|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642925|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642926|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642927|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642928|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642929|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642930|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642931|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642932|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642933|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642934|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642935|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642936|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642937|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642938|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642939|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642940|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642941|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642942|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642943|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642944|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642945|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642946|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642947|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642948|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642949|NCT00419952|E2|Reported Event|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
642950|NCT00419952|E1|Reported Event|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
642951|NCT00419926|B3|Baseline|Total|Total of all reporting groups
642952|NCT00419926|B2|Baseline|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
642953|NCT00419926|B1|Baseline|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642954|NCT00419926|P2|Participant Flow|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
642955|NCT00419926|P1|Participant Flow|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642956|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
642957|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642958|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
643004|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
643005|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642959|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642960|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
642961|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642962|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
642963|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642964|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
642965|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642966|NCT00419926|E2|Reported Event|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
642967|NCT00419926|E1|Reported Event|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
642968|NCT00419770|B3|Baseline|Total|Total of all reporting groups
642969|NCT00419770|B2|Baseline|Placebo|Placebo control plus background liposomal amphotericin
642970|NCT00419770|B1|Baseline|Deferasirox|Deferasirox plus liposomal amphotericin
642971|NCT00419770|P2|Participant Flow|Placebo|Placebo control plus background liposomal amphotericin
642972|NCT00419770|P1|Participant Flow|Deferasirox|Deferasirox plus liposomal amphotericin
642973|NCT00419770|O2|Outcome|Placebo|Placebo control plus background liposomal amphotericin
642974|NCT00419770|O1|Outcome|Deferasirox|Deferasirox plus liposomal amphotericin
642975|NCT00419770|E2|Reported Event|Placebo|Placebo control plus background liposomal amphotericin
642976|NCT00419770|E1|Reported Event|Deferasirox|Deferasirox plus liposomal amphotericin
642977|NCT00419757|B3|Baseline|Total|Total of all reporting groups
642978|NCT00419757|B2|Baseline|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642979|NCT00419757|B1|Baseline|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642980|NCT00419757|P2|Participant Flow|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642981|NCT00419757|P1|Participant Flow|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642982|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
642983|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
642984|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
642985|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
642986|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642987|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642988|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642989|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642990|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642991|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642992|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642993|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642994|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642995|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642996|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642997|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
642998|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
642999|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
643000|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
643001|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
643002|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
643003|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
643006|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
643007|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
643008|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
643009|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
643010|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
643011|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
643012|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
643013|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
643014|NCT00419757|E2|Reported Event|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
643015|NCT00419757|E1|Reported Event|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
643016|NCT00419744|B4|Baseline|Total|Total of all reporting groups
643017|NCT00419744|B3|Baseline|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643018|NCT00419744|B2|Baseline|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643019|NCT00419744|B1|Baseline|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643020|NCT00419744|P3|Participant Flow|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643021|NCT00419744|P2|Participant Flow|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643022|NCT00419744|P1|Participant Flow|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643023|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643024|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643025|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643026|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643027|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643028|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643029|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643030|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643031|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643032|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643033|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643034|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643035|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643036|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643037|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643038|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643039|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643040|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643041|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643042|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643043|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643044|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643045|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643046|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643047|NCT00419744|E3|Reported Event|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
643048|NCT00419744|E2|Reported Event|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
643049|NCT00419744|E1|Reported Event|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
643050|NCT00419445|B4|Baseline|Total|Total of all reporting groups
643051|NCT00419445|B3|Baseline|150 mg Tid|
643052|NCT00419445|B2|Baseline|75 mg Tid|
643053|NCT00419445|B1|Baseline|25 mg Tid|
643054|NCT00419445|P3|Participant Flow|150 mg Tid|
643055|NCT00419445|P2|Participant Flow|75 mg Tid|
643056|NCT00419445|P1|Participant Flow|25 mg Tid|
643057|NCT00419445|O3|Outcome|150 mg Tid|
643058|NCT00419445|O2|Outcome|75 mg Tid|
643059|NCT00419445|O1|Outcome|25 mg Tid|
643060|NCT00419445|E3|Reported Event|150 mg Tid|
643063|NCT00419393|B1|Baseline|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643064|NCT00419393|P1|Participant Flow|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643065|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643066|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643067|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643068|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643069|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643070|NCT00419393|E1|Reported Event|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
643071|NCT00419380|B3|Baseline|Total|Total of all reporting groups
643072|NCT00419380|B2|Baseline|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
643073|NCT00419380|B1|Baseline|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
643074|NCT00419380|P2|Participant Flow|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
643075|NCT00419380|P1|Participant Flow|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
643076|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
643077|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
643078|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
643079|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
643080|NCT00419380|E2|Reported Event|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
643081|NCT00419380|E1|Reported Event|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
643082|NCT00419341|B1|Baseline|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643083|NCT00419341|P1|Participant Flow|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643084|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643085|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643086|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643087|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643088|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643089|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643090|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643091|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643092|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643093|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643094|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643095|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643096|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643097|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643098|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643099|NCT00419341|O2|Outcome|IVIG (Privigen; Previous Study)|Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
643100|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643101|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643102|NCT00419341|E1|Reported Event|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
643103|NCT00419315|B3|Baseline|Total|Total of all reporting groups
643104|NCT00419315|B2|Baseline|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643105|NCT00419315|B1|Baseline|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643106|NCT00419315|P2|Participant Flow|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643107|NCT00419315|P1|Participant Flow|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643108|NCT00419315|O2|Outcome|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643109|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643110|NCT00419315|O2|Outcome|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643111|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643112|NCT00419315|E2|Reported Event|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643113|NCT00419315|E1|Reported Event|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
643114|NCT00419263|B4|Baseline|Total|Total of all reporting groups
643115|NCT00419263|B3|Baseline|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643116|NCT00419263|B2|Baseline|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643117|NCT00419263|B1|Baseline|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643118|NCT00419263|P3|Participant Flow|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643119|NCT00419263|P2|Participant Flow|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643120|NCT00419263|P1|Participant Flow|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643121|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643122|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643123|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643124|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643125|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643126|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643127|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643128|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643129|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643130|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643131|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643132|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643133|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643134|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643135|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643136|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643137|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643202|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
643138|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643139|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643140|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643141|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643142|NCT00419263|E4|Reported Event|Total|Total number of subjects who received at least 1 dose of study drug
643143|NCT00419263|E3|Reported Event|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
643144|NCT00419263|E2|Reported Event|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
643145|NCT00419263|E1|Reported Event|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
643146|NCT00419159|B3|Baseline|Total|Total of all reporting groups
643147|NCT00419159|B2|Baseline|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643148|NCT00419159|B1|Baseline|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643149|NCT00419159|P2|Participant Flow|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643150|NCT00419159|P1|Participant Flow|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643151|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643152|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643153|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643154|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643155|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643156|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643157|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643158|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643159|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643160|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643161|NCT00419159|E2|Reported Event|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643162|NCT00419159|E1|Reported Event|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
643163|NCT00419120|B1|Baseline|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
643164|NCT00419120|P1|Participant Flow|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
643165|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
643166|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
643167|NCT00419120|E1|Reported Event|Safety Population|All patients undergoing screeing and meeting inclusion/exclusion criteria
643168|NCT00419094|B3|Baseline|Total|Total of all reporting groups
643169|NCT00419094|B2|Baseline|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
643170|NCT00419094|B1|Baseline|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
643171|NCT00419094|P2|Participant Flow|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
643172|NCT00419094|P1|Participant Flow|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
643173|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
643174|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
643175|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
643176|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
643177|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
643178|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
643179|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
643180|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
644324|NCT00414661|B5|Baseline|Total|Total of all reporting groups
643181|NCT00419094|E2|Reported Event|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
643182|NCT00419094|E1|Reported Event|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
643183|NCT00419003|B3|Baseline|Total|Total of all reporting groups
643184|NCT00419003|B2|Baseline|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
643185|NCT00419003|B1|Baseline|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
643186|NCT00419003|P2|Participant Flow|Placebo Pre-Treatment (Phase I)/Placebo (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
643187|NCT00419003|P1|Participant Flow|Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
643188|NCT00419003|O2|Outcome|Placebo|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo.
643189|NCT00419003|O1|Outcome|Riluzole Group|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo. One patient in the riluzole group was discontinued/withdrew consent before completing the study.
643190|NCT00419003|E5|Reported Event|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
643191|NCT00419003|E4|Reported Event|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
643192|NCT00419003|E3|Reported Event|Ketamine|IV infusion of 0.5 mg/kg of Ketamine Hydrochloride
643193|NCT00419003|E2|Reported Event|Placebo|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
643194|NCT00419003|E1|Reported Event|Riluzole Group|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
643195|NCT00418977|B3|Baseline|Total|Total of all reporting groups
643196|NCT00418977|B2|Baseline|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
643197|NCT00418977|B1|Baseline|Family Based Therapy|Participants received family based therapy (FBT)
643198|NCT00418977|P2|Participant Flow|Individual Supportive Psychotherapy|"Participants received individual supportive psychotherapy (ISP)~Individual Supportive Psychotherapy: The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment."
643199|NCT00418977|P1|Participant Flow|Family Based Therapy|"Participants received family based therapy (FBT)~Family-Based Therapy (Maudsley Method): The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction."
643200|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
643204|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
643205|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
643206|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
643207|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
643208|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
643209|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
643210|NCT00418977|E2|Reported Event|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
643211|NCT00418977|E1|Reported Event|Family Based Therapy|Participants received family based therapy (FBT)
643212|NCT00418964|B4|Baseline|Total|Total of all reporting groups
643213|NCT00418964|B3|Baseline|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
643214|NCT00418964|B2|Baseline|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
643215|NCT00418964|B1|Baseline|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
643216|NCT00418964|P3|Participant Flow|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
643217|NCT00418964|P2|Participant Flow|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
643218|NCT00418964|P1|Participant Flow|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
643219|NCT00418964|O3|Outcome|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
643220|NCT00418964|O2|Outcome|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
643221|NCT00418964|O1|Outcome|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
643222|NCT00418964|E3|Reported Event|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
643223|NCT00418964|E2|Reported Event|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
643224|NCT00418964|E1|Reported Event|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
643225|NCT00418951|B4|Baseline|Total|Total of all reporting groups
643226|NCT00418951|B3|Baseline|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
643227|NCT00418951|B2|Baseline|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
643228|NCT00418951|B1|Baseline|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
643229|NCT00418951|P3|Participant Flow|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
643230|NCT00418951|P2|Participant Flow|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
643231|NCT00418951|P1|Participant Flow|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
643232|NCT00418951|O3|Outcome|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
643233|NCT00418951|O2|Outcome|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
643234|NCT00418951|O1|Outcome|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
643235|NCT00418951|E3|Reported Event|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
643236|NCT00418951|E2|Reported Event|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
643237|NCT00418951|E1|Reported Event|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
643238|NCT00418938|B3|Baseline|Total|Total of all reporting groups
643239|NCT00418938|B2|Baseline|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643240|NCT00418938|B1|Baseline|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643241|NCT00418938|P2|Participant Flow|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643242|NCT00418938|P1|Participant Flow|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643243|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643244|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643245|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643246|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643247|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643248|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643249|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643250|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643251|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643252|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643300|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643253|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643254|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643255|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643256|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643257|NCT00418938|E2|Reported Event|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
643258|NCT00418938|E1|Reported Event|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
643259|NCT00418886|B3|Baseline|Total|Total of all reporting groups
643260|NCT00418886|B2|Baseline|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643261|NCT00418886|B1|Baseline|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643262|NCT00418886|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643263|NCT00418886|P1|Participant Flow|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643264|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643265|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643266|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643267|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643268|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643269|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643270|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643271|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643272|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643273|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643274|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643275|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643276|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643277|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643278|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643279|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643280|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643281|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643282|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643283|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643284|NCT00418886|E2|Reported Event|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643285|NCT00418886|E1|Reported Event|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
643286|NCT00418834|B3|Baseline|Total|Total of all reporting groups
643287|NCT00418834|B2|Baseline|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643288|NCT00418834|B1|Baseline|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643289|NCT00418834|P2|Participant Flow|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643290|NCT00418834|P1|Participant Flow|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643291|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643292|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643293|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643294|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643295|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643296|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643297|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643298|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643299|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643301|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643302|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643303|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643304|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643305|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643306|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643307|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643308|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643309|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643310|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643311|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643312|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643313|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643314|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643315|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643316|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643317|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643318|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643319|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643320|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643321|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643322|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643323|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643324|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643325|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643326|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643327|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643328|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643329|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643330|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643331|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643332|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643333|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643334|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643335|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643336|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643337|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643338|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643339|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643340|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643341|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643342|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643343|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643344|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643345|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643346|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643347|NCT00418834|E2|Reported Event|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
643348|NCT00418834|E1|Reported Event|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
643349|NCT00418717|B1|Baseline|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
643350|NCT00418717|P1|Participant Flow|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
643351|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
643352|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
643353|NCT00418717|E1|Reported Event|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
643354|NCT00418691|B4|Baseline|Total|Total of all reporting groups
643355|NCT00418691|B3|Baseline|Modafinil|18 mg PO once daily for 4 weeks
643356|NCT00418691|B2|Baseline|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
643357|NCT00418691|B1|Baseline|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
643358|NCT00418691|P3|Participant Flow|Modafinil|18 mg PO once daily for 4 weeks
643359|NCT00418691|P2|Participant Flow|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
643360|NCT00418691|P1|Participant Flow|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
643361|NCT00418691|O3|Outcome|Modafinil|18 mg PO once daily for 4 weeks
643362|NCT00418691|O2|Outcome|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
643363|NCT00418691|O1|Outcome|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
643364|NCT00418691|E3|Reported Event|Modafinil|18 mg PO once daily for 4 weeks
643365|NCT00418691|E2|Reported Event|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
643366|NCT00418691|E1|Reported Event|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
643367|NCT00418665|B4|Baseline|Total|Total of all reporting groups
643368|NCT00418665|B3|Baseline|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643369|NCT00418665|B2|Baseline|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643370|NCT00418665|B1|Baseline|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643371|NCT00418665|P3|Participant Flow|Romiplostim (AMG 531) 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643372|NCT00418665|P2|Participant Flow|Romiplostim (AMG 531) 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643373|NCT00418665|P1|Participant Flow|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643374|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643375|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643376|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643377|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643378|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643379|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643380|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643381|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643382|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643383|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643384|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643385|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
643386|NCT00418665|E3|Reported Event|Romiplostim 750 µg|
643387|NCT00418665|E2|Reported Event|Romiplostim 500 µg|
643388|NCT00418665|E1|Reported Event|Placebo|
643389|NCT00418574|B3|Baseline|Total|Total of all reporting groups
643390|NCT00418574|B2|Baseline|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643391|NCT00418574|B1|Baseline|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643392|NCT00418574|P2|Participant Flow|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643393|NCT00418574|P1|Participant Flow|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643394|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643395|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643396|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643397|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643398|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643399|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643400|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643401|NCT00418574|E2|Reported Event|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643402|NCT00418574|E1|Reported Event|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
643403|NCT00418561|B4|Baseline|Total|Total of all reporting groups
643404|NCT00418561|B3|Baseline|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643405|NCT00418561|B2|Baseline|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643406|NCT00418561|B1|Baseline|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643407|NCT00418561|P3|Participant Flow|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643408|NCT00418561|P2|Participant Flow|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643409|NCT00418561|P1|Participant Flow|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643410|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643411|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643412|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643413|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643414|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643415|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643416|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643417|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643418|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643419|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643420|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643421|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643422|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643423|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643544|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
643424|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643425|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643426|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643427|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643428|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643429|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643430|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643431|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643432|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643433|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643434|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643435|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643436|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643437|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643438|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643439|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643440|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643441|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643442|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643443|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643444|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643445|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643446|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643447|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643448|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643449|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643450|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643451|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643452|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643453|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643454|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643455|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643456|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643457|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643458|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643459|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643460|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643461|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643462|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643463|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643464|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643465|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643466|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643467|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643468|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643469|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643470|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643471|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643472|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643473|NCT00418561|E3|Reported Event|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643474|NCT00418561|E2|Reported Event|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643475|NCT00418561|E1|Reported Event|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
643476|NCT00418522|B3|Baseline|Total|Total of all reporting groups
643477|NCT00418522|B2|Baseline|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643478|NCT00418522|B1|Baseline|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643479|NCT00418522|P2|Participant Flow|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643480|NCT00418522|P1|Participant Flow|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643481|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643482|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643483|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643484|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643485|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643486|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643487|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643488|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643489|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643490|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643491|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643492|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643493|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643494|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643495|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643496|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643497|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643498|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643499|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643500|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643501|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643502|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643503|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643504|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643505|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643506|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643507|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643508|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643509|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643510|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643511|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643512|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643513|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643514|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643515|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643516|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643517|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643518|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643519|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643520|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643521|NCT00418522|E2|Reported Event|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
643522|NCT00418522|E1|Reported Event|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
643523|NCT00418379|B4|Baseline|Total|Total of all reporting groups
643524|NCT00418379|B3|Baseline|Placebo|Placebo tablet
643525|NCT00418379|B2|Baseline|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
643526|NCT00418379|B1|Baseline|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
643527|NCT00418379|P3|Participant Flow|Placebo|Placebo tablet
643528|NCT00418379|P2|Participant Flow|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
643529|NCT00418379|P1|Participant Flow|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
643530|NCT00418379|O3|Outcome|Placebo|Placebo tablet
643531|NCT00418379|O2|Outcome|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
643532|NCT00418379|O1|Outcome|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
643533|NCT00418379|E3|Reported Event|Placebo|Placebo tablet
643534|NCT00418379|E2|Reported Event|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
643535|NCT00418379|E1|Reported Event|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
643536|NCT00418314|B3|Baseline|Total|Total of all reporting groups
643537|NCT00418314|B2|Baseline|Control|Empiric programming or one-time optimization using a non-IEGM method.
643538|NCT00418314|B1|Baseline|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
643539|NCT00418314|P2|Participant Flow|Control|Empiric programming or one-time optimization using a non-IEGM method.
643540|NCT00418314|P1|Participant Flow|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
643541|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
643542|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
643543|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
645131|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
643545|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
643546|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
643547|NCT00418314|E2|Reported Event|Control|Empiric programming or one-time optimization using a non-IEGM method.
643548|NCT00418314|E1|Reported Event|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
643549|NCT00418262|B1|Baseline|Atomoxetine HCL (Strattera)|The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This “titration” will occur at each visit.
643550|NCT00418262|P1|Participant Flow|Atomoxetine HCL (Strattera)|The subjects will receive atomoxetine at 0.5 mg/kg/day for the first week. The children will be seen weekly for assessment for 4 weeks, every month for two months, then every three months until the 12 month treatment period is complete. After one week of treatment response will be reassessed and the dose will be increased to 1.0 mg/kg/d unless there are excessive side effects. If there are mild side effects the dose will be held the same. If there are excessive side effects the dose will be split to 0.25 mg/kg-d BID. At visit 3 the dose will be increased to 1.0 or 1.4 mg/kg-d, depending on the previous dose, if there are not excessive side effects. This titration will occur at each visit.
643551|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|"Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)~atomoxetine hydrochloride: Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food."
643552|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643553|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643554|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643555|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643556|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|One additional subject left the study
643557|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643558|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|"Visit 1~One additional subject left the study"
643559|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643560|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643561|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|One additional subject left the study
643562|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|"Visit 1~One additional subject left the study"
643563|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643564|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643565|NCT00418262|O1|Outcome|Atomoxetine HCL (Strattera)|Treatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
643566|NCT00418262|E1|Reported Event|Atomoxetine HCL (Strattera)|The subjects received 7 days of atomoxetine at 0.5 mg/kg/day. The children were seen weekly for assessment for 4 weeks then every two weeks until the eight week double blind period was completed. After each week of treatment, response was reassessed and the dose was increased to 1.0 then 1.4 mg/kg/d unless there were excessive side effects. The subjects were then invited to continue for 1 year to assess safety and efficacy
643567|NCT00418184|B3|Baseline|Total|Total of all reporting groups
643568|NCT00418184|B2|Baseline|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
643569|NCT00418184|B1|Baseline|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
643570|NCT00418184|P2|Participant Flow|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
643571|NCT00418184|P1|Participant Flow|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
643572|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
643573|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
643574|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
643575|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
643576|NCT00418184|E2|Reported Event|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
643577|NCT00418184|E1|Reported Event|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
643578|NCT00418145|B1|Baseline|Total Study Participants|Overall study participants - Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
643579|NCT00418145|P1|Participant Flow|Total Study Participants|Overall study participants. Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
643580|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
643581|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
643582|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
643583|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
643584|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
643585|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
643586|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
643587|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
643588|NCT00418145|E2|Reported Event|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
643589|NCT00418145|E1|Reported Event|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
643590|NCT00418093|B1|Baseline|Group 1|
643591|NCT00418093|P1|Participant Flow|Chemotherapy Group|Oxaliplatin plus Gemcitabine plus Bevacizumab
643592|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
643593|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
643594|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
643595|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
643596|NCT00418093|E1|Reported Event|Group 1|
643597|NCT00418028|B3|Baseline|Total|Total of all reporting groups
643598|NCT00418028|B2|Baseline|Arm B (Ccont)|"Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
643599|NCT00418028|B1|Baseline|Arm A (Cint)|"Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
643600|NCT00418028|P2|Participant Flow|Arm B (Ccont)|"Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
643601|NCT00418028|P1|Participant Flow|Arm A (Cint)|"Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
643602|NCT00418028|O2|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
643603|NCT00418028|O1|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
643604|NCT00418028|O2|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
643605|NCT00418028|O1|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
643606|NCT00418028|O2|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
643607|NCT00418028|O1|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
643608|NCT00418028|O2|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
643609|NCT00418028|O1|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
643610|NCT00418028|O2|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
643611|NCT00418028|O1|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
643612|NCT00418028|O2|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
643643|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643613|NCT00418028|O1|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
643614|NCT00418028|O2|Outcome|Arm B (Ccont)|Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
643615|NCT00418028|O1|Outcome|Arm A (Cint)|Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
643616|NCT00418028|E2|Reported Event|B Ccont|"Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
643617|NCT00418028|E1|Reported Event|A Cint|"Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.~drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome."
643618|NCT00418015|B5|Baseline|Total|Total of all reporting groups
643619|NCT00418015|B4|Baseline|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643620|NCT00418015|B3|Baseline|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643621|NCT00418015|B2|Baseline|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643622|NCT00418015|B1|Baseline|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643623|NCT00418015|P4|Participant Flow|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643624|NCT00418015|P3|Participant Flow|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643625|NCT00418015|P2|Participant Flow|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643626|NCT00418015|P1|Participant Flow|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643627|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643628|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643629|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643630|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643631|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643632|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643633|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643634|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643635|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643636|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643637|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643638|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643639|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643640|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643641|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643642|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643644|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643645|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643646|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643647|NCT00418015|E4|Reported Event|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
643648|NCT00418015|E3|Reported Event|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
643649|NCT00418015|E2|Reported Event|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
643650|NCT00418015|E1|Reported Event|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
643651|NCT00417989|B3|Baseline|Total|Total of all reporting groups
643652|NCT00417989|B2|Baseline|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643653|NCT00417989|B1|Baseline|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643654|NCT00417989|P2|Participant Flow|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643655|NCT00417989|P1|Participant Flow|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643656|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643657|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643658|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643659|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643660|NCT00417989|O2|Outcome|Multiple Daily Injections (MDI)|MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year
643661|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|"722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year~MiniMed Paradigm REAL-Time System: Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter"
643662|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643663|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643664|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643665|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643666|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643667|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643668|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643669|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643670|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643671|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643672|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643673|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643674|NCT00417989|E2|Reported Event|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
643675|NCT00417989|E1|Reported Event|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
643676|NCT00417976|B1|Baseline|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
643677|NCT00417976|P1|Participant Flow|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
643678|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
643679|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
643680|NCT00417976|E1|Reported Event|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
643681|NCT00417963|B1|Baseline|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
643682|NCT00417963|P1|Participant Flow|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
643683|NCT00417963|O2|Outcome|6 Month Restenosis|Number of participants with restenosis at 6 months from implantation.
643684|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
643685|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
643686|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
649835|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
643687|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
643688|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
643689|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
643690|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
643691|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
643692|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
643693|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
643694|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
643695|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
643696|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
643697|NCT00417963|E1|Reported Event|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
643698|NCT00417885|B1|Baseline|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643699|NCT00417885|P1|Participant Flow|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643700|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643701|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643702|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643703|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643704|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643705|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643706|NCT00417885|E1|Reported Event|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
643707|NCT00417612|B3|Baseline|Total|Total of all reporting groups
643708|NCT00417612|B2|Baseline|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643709|NCT00417612|B1|Baseline|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643710|NCT00417612|P2|Participant Flow|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643711|NCT00417612|P1|Participant Flow|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce Parathyroid Hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643712|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643713|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643714|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643715|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce parathyroid hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643716|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643717|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643718|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643719|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643720|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643721|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643722|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643723|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
645581|NCT00412958|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
643724|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643725|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643726|NCT00417612|O3|Outcome|Paricalcitol (Children Ages 9-17)|Pediatric patients ages 9-17 given paricalcitol
643727|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643728|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643729|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643730|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643731|NCT00417612|E2|Reported Event|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
643732|NCT00417612|E1|Reported Event|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
643733|NCT00417482|B4|Baseline|Total|Total of all reporting groups
643734|NCT00417482|B3|Baseline|Phase B Arm 3: Placebo-Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
643735|NCT00417482|B2|Baseline|Phase B Arm 2: Risperidone -Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
643736|NCT00417482|B1|Baseline|Phase B Arm 1: Risperidone-Risperidone|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
643737|NCT00417482|P3|Participant Flow|Phase B Arm 3: Placebo-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 3: Patients were randomized to placebo for 32 weeks."
643738|NCT00417482|P2|Participant Flow|Phase B Arm 2: Risperidone-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 2: Risperidone for 16 weeks followed by placebo for 16 weeks;"
643739|NCT00417482|P1|Participant Flow|Arm 1: Risperidone-Risperidone|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 1: Risperidone for 16 weeks followed by risperidone for 16 weeks; Risperidone open label flexible dose was administered at a dose of 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for the randomized trial"
643740|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
643741|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
643742|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
643743|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
643744|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
643745|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
643746|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
643747|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
643748|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
643749|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
643750|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
643751|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
643752|NCT00417482|O2|Outcome|Arm 2: Risperidone - Placebo|Subjects in Arm 2 who did not relapse or terminate from the study in the first 16 weeks of Phase B received placebo in the second 16 weeks of Phase B.
643753|NCT00417482|O1|Outcome|Arm 1: Risperidone - Risperidone|Subjects in Arm 1 who did not relapse or terminate from the study in the first 16 weeks of Phase B continued to receive risperidone in the second 16 weeks of Phase B.
643754|NCT00417482|O3|Outcome|Phase B Arm 3: Placebo-Placebo|"40 patients randomized to Phase B Arm 3 received placebo for 32 weeks. For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
643755|NCT00417482|O2|Outcome|Phase B Arm 2: Risperidone -Placebo|"38 patients randomized to Phase B Arm 2 received risperidone therapy for 16 weeks followed by placebo for 16 weeks.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
643756|NCT00417482|O1|Outcome|Phase B Arm 1: Risperidone-Risperidone|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks.
643757|NCT00417482|E5|Reported Event|Wek 17-32 Phase B Arm 3: Placebo -Placebo|13 patients completed Week 0-16 of Phase B Arm 3 and entered Week 17-32 were they were given placebo for another 16 weeks.
643758|NCT00417482|E4|Reported Event|Wk 17-32 Phase B Arm 2: Risperdone-Placebo|27 patients completed Wk 0-16 of Phase B Arm 2 and entered Week 17-32 of Phase B Arm 2 where they receive placebo for 16 weeks.
643759|NCT00417482|E3|Reported Event|Wk 17-32 Phase B Arm 1: Risperdone-Risperdone|13 patients completed Wk 0-16 of Phase 2 Arm 1 and entered Wk 17-32 where they received risperidone for another 16 weeks.
643760|NCT00417482|E2|Reported Event|Wk 0-16 Phase B Arm 3: Placebo -Placebo|40 patients randomized to Phase B Arm 3 received placebo for 32 weeks.
643761|NCT00417482|E1|Reported Event|Wk0-16 Phase B Arm 1 (Risp-Risp) & Arm 2 (Risp-Pla)|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks; 38 patients randomized to Phase B Arm 2 received risperidone for 16 weeks followed by placebo for 16 weeks. Therefore there were a total of 70 patients in this group.
643762|NCT00417417|B3|Baseline|Total|Total of all reporting groups
643763|NCT00417417|B2|Baseline|Placebo|placebo injected every two weeks for two months
643764|NCT00417417|B1|Baseline|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
643765|NCT00417417|P2|Participant Flow|Placebo|placebo injected every two weeks x 4 administrations
643766|NCT00417417|P1|Participant Flow|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
643767|NCT00417417|O2|Outcome|Placebo|Placebo subcutaneous injection x 4 over 8 weeks
643768|NCT00417417|O1|Outcome|Rilonacept|Rilonacept 320 mg subcutaneously x4 over 8 weeks
643769|NCT00417417|O2|Outcome|Placebo|Placebo x 4 injections over 8 weeks
643770|NCT00417417|O1|Outcome|Rilonacept|rilonacept 320 mg x 4 administrations over 8 weeks.
643771|NCT00417417|E2|Reported Event|Placebo|placebo injected every two weeks for two months
643772|NCT00417417|E1|Reported Event|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
643773|NCT00417274|B1|Baseline|Quinacrine Treatment|Uncontrolled treatment arm
643774|NCT00417274|P1|Participant Flow|Quinacrine Treatment|100 mg once a day
643775|NCT00417274|O1|Outcome|Quinacrine Treatment|100 mg once a day
643776|NCT00417274|E1|Reported Event|Quinacrine Treatment|Uncontrolled treatment arm
643777|NCT00417248|B1|Baseline|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
643778|NCT00417248|P1|Participant Flow|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
643779|NCT00417248|O1|Outcome|Investigational Treatment|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
643780|NCT00417248|O1|Outcome|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
643872|NCT00416624|B1|Baseline|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643781|NCT00417248|E1|Reported Event|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
643782|NCT00417170|B3|Baseline|Total|Total of all reporting groups
643783|NCT00417170|B2|Baseline|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643784|NCT00417170|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643785|NCT00417170|P2|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643786|NCT00417170|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643787|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643788|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643789|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643790|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643791|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643792|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643793|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643794|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643795|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643796|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643797|NCT00417170|E2|Reported Event|Amlodipine 5mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
643798|NCT00417170|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
643799|NCT00417079|B3|Baseline|Total|Total of all reporting groups
643800|NCT00417079|B2|Baseline|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643801|NCT00417079|B1|Baseline|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643802|NCT00417079|P2|Participant Flow|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643803|NCT00417079|P1|Participant Flow|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643804|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643805|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643806|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643807|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643808|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643809|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643810|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643811|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643812|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643813|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643814|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643815|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643816|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643817|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643818|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643819|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643820|NCT00417079|E2|Reported Event|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643821|NCT00417079|E1|Reported Event|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
643822|NCT00417027|B4|Baseline|Total|Total of all reporting groups
643823|NCT00417027|B3|Baseline|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643873|NCT00416624|P4|Participant Flow|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
649836|NCT00402987|O3|Outcome|Placebo|
643824|NCT00417027|B2|Baseline|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643825|NCT00417027|B1|Baseline|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643826|NCT00417027|P3|Participant Flow|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643827|NCT00417027|P2|Participant Flow|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643828|NCT00417027|P1|Participant Flow|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643829|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643830|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643831|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643832|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643833|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643834|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643835|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643836|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643837|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643838|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643839|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643840|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643841|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643842|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643843|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643844|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643845|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643846|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643847|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643848|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643849|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643850|NCT00417027|E3|Reported Event|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643851|NCT00417027|E2|Reported Event|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
643852|NCT00417027|E1|Reported Event|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
643853|NCT00416884|B1|Baseline|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
643854|NCT00416884|P1|Participant Flow|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
643855|NCT00416884|O1|Outcome|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
643856|NCT00416884|E1|Reported Event|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
643857|NCT00416793|B1|Baseline|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
643858|NCT00416793|P1|Participant Flow|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
643859|NCT00416793|O1|Outcome|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
643860|NCT00416793|E1|Reported Event|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
643861|NCT00416715|B1|Baseline|Treatment (Letrozole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.~letrozole: Given PO~calcium carbonate: Given PO~laboratory biomarker analysis: Optional correlative studies~calcium citrate: Given PO~calcium glucarate: Given PO~calcium gluconate: Given PO~cholecalciferol: Given PO~assessment of therapy complications: Ancillary studies~musculoskeletal complications management/prevention: Correlative studies"
643862|NCT00416715|P1|Participant Flow|Treatment (Letrozole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.~letrozole: Given PO~calcium carbonate: Given PO~laboratory biomarker analysis: Optional correlative studies~calcium citrate: Given PO~calcium glucarate: Given PO~calcium gluconate: Given PO~cholecalciferol: Given PO~assessment of therapy complications: Ancillary studies~musculoskeletal complications management/prevention: Correlative studies"
643863|NCT00416715|O2|Outcome|Post Vitamin D Repletion (1 Month)|Those receiving Letrezole + vitamin D3
643864|NCT00416715|O1|Outcome|Baseline|Those receiving Letrozole + vitamin D3
643865|NCT00416715|O2|Outcome|Post Vitamin D Repletion (1 Month)|Patients with vitamin D deficiency who experience myalgias, arthralgias and/or joint stiffness.
643866|NCT00416715|O1|Outcome|Baseline|All patients that are evaluable for joint aches and vitamin D levels.
643867|NCT00416715|E1|Reported Event|Treatment (Letrezole)|"Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.~letrozole: Given PO~calcium carbonate: Given PO~laboratory biomarker analysis: Optional correlative studies~calcium citrate: Given PO~calcium glucarate: Given PO~calcium gluconate: Given PO~cholecalciferol: Given PO~assessment of therapy complications: Ancillary studies~musculoskeletal complications management/prevention: Correlative studies"
643868|NCT00416624|B5|Baseline|Total|Total of all reporting groups
643869|NCT00416624|B4|Baseline|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643870|NCT00416624|B3|Baseline|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643871|NCT00416624|B2|Baseline|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643874|NCT00416624|P3|Participant Flow|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643875|NCT00416624|P2|Participant Flow|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643876|NCT00416624|P1|Participant Flow|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643877|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643878|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643879|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643880|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643881|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643882|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643883|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643884|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643885|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643886|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643887|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643888|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643889|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643890|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643891|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643892|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643893|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643894|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643895|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643896|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643897|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643898|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643899|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643900|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643901|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643902|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643903|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643904|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643905|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643906|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643907|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643908|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643909|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643910|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643911|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643912|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643913|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643914|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643915|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
644164|NCT00415519|O1|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
643916|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643917|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643918|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643919|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643920|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643921|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643922|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643923|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643924|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643925|NCT00416624|E4|Reported Event|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
643926|NCT00416624|E3|Reported Event|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643927|NCT00416624|E2|Reported Event|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
643928|NCT00416624|E1|Reported Event|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
643929|NCT00416598|B1|Baseline|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
643930|NCT00416598|P1|Participant Flow|Treatment (Chemotherapy, PBSC or Bone Marrow Transplantation)|"See Detailed Description:~Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy."
643931|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
643932|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
643933|NCT00416598|E1|Reported Event|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
643934|NCT00416572|B4|Baseline|Total|Total of all reporting groups
643935|NCT00416572|B3|Baseline|Control Condition|Participants received care as usual.
643936|NCT00416572|B2|Baseline|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
643937|NCT00416572|B1|Baseline|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
643938|NCT00416572|P3|Participant Flow|Control Condition|Participants received care as usual.
643939|NCT00416572|P2|Participant Flow|Nutrition Education Intervention|"Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.~The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it."
643940|NCT00416572|P1|Participant Flow|Education Intervention|"Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.~Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read."
643941|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
643942|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
643943|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
643944|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
643945|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
643946|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
643947|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
643948|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
643949|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
643950|NCT00416572|E3|Reported Event|Control Condition|Participants received care as usual.
643951|NCT00416572|E2|Reported Event|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
643952|NCT00416572|E1|Reported Event|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
643953|NCT00416520|B3|Baseline|Total|Total of all reporting groups
643954|NCT00416520|B2|Baseline|Sevelamer (Open-label Period)|
643955|NCT00416520|B1|Baseline|MCI-196 (Open-label Period)|
643956|NCT00416520|P4|Participant Flow|Placebo (Placebo-controlled Withdrawal Period)|"dose level at the end of dose titration in the flexible dose period~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants One subject did not take any study medication and excluded from Baseline Participants."
643957|NCT00416520|P3|Participant Flow|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
643958|NCT00416520|P2|Participant Flow|Sevelamer (Open-label Period)|"2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated~There was a gap of 2 subjects between STARTED and Overall Number of Baseline Participants.~Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from Baseline Participants of Sevelamer group.~However, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
643959|NCT00416520|P1|Participant Flow|MCI-196 (Open-label Period)|"3, 6, 9, 12, or 15g/day as titrated~There was a gap of 3 subjects between STARTED and Overall Number of Baseline Participants.~Two subjects were randomised to receive MCI-196, but did not take study medication. These 2 subjects were excluded from Baseline Participants of MCI-196 group.~In addition, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
643960|NCT00416520|O2|Outcome|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
643961|NCT00416520|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
643962|NCT00416520|O2|Outcome|Placebo (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
643963|NCT00416520|O1|Outcome|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
643964|NCT00416520|E4|Reported Event|Placebo (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
643965|NCT00416520|E3|Reported Event|MCI-196 (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
643966|NCT00416520|E2|Reported Event|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
643967|NCT00416520|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
643968|NCT00416494|B3|Baseline|Total|Total of all reporting groups
643969|NCT00416494|B2|Baseline|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643970|NCT00416494|B1|Baseline|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
643971|NCT00416494|P2|Participant Flow|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643972|NCT00416494|P1|Participant Flow|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
643973|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643974|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
649837|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
643975|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643976|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
643977|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643978|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
643979|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643980|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
643981|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643982|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
643983|NCT00416494|E2|Reported Event|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
643984|NCT00416494|E1|Reported Event|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
643985|NCT00416455|B3|Baseline|Total|Total of all reporting groups
643986|NCT00416455|B2|Baseline|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643987|NCT00416455|B1|Baseline|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643988|NCT00416455|P2|Participant Flow|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643989|NCT00416455|P1|Participant Flow|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643990|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643991|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643992|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643993|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643994|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643995|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643996|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643997|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643998|NCT00416455|E2|Reported Event|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
643999|NCT00416455|E1|Reported Event|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
644000|NCT00416195|B3|Baseline|Total|Total of all reporting groups
644043|NCT00416078|E2|Reported Event|Caregiver Brief Supportive Phone Calls|caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
644044|NCT00416078|E1|Reported Event|Caregiver Website Support|caregiver access to website support for 6 months embedded in one year of customary care
649838|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
644001|NCT00416195|B2|Baseline|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
644002|NCT00416195|B1|Baseline|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
644003|NCT00416195|P2|Participant Flow|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
644004|NCT00416195|P1|Participant Flow|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
644005|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
644006|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
644007|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
644008|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
644009|NCT00416195|E2|Reported Event|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
644010|NCT00416195|E1|Reported Event|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
644011|NCT00416182|B3|Baseline|Total|Total of all reporting groups
644012|NCT00416182|B2|Baseline|Placebo|2.5 mL of placebo comparator
644013|NCT00416182|B1|Baseline|Pulmozyme (Dornase Alfa)|2.5 mg/2.5 mL of intranasal Pulmozyme
644014|NCT00416182|P2|Participant Flow|Placebo|2.5mg/2.5mL placebo administered intranasally once daily
644015|NCT00416182|P1|Participant Flow|Pulmozyme (Dornase Alfa)|2.5 mg/2.5mL of Pulmozyme administered intranasally once daily
644016|NCT00416182|O2|Outcome|Placebo|Percent predicted forced expiratory volume in 1 second recorded
644017|NCT00416182|O1|Outcome|Pulmozyme|Percent predicted for forced expiratory volume in 1 second recorded
644018|NCT00416182|O2|Outcome|Placebo|Scores from the Chronic Sinusitis Survey recorded
644019|NCT00416182|O1|Outcome|Pulmozyme|Scores from the Chronic Sinusitis Survey
644020|NCT00416182|O2|Outcome|Placebo|endoscopic photos of sinuses by ENT surgeon, independently and blindly scored by two surgeons. Scores of 0,1,2 based on disease severity.
644021|NCT00416182|O1|Outcome|Pulmozyme|endoscopic photos of sinuses by ENT surgeon independently and blindly scored by two surgeons with scale of 0,1,2 to indicate severity of disease
644022|NCT00416182|O2|Outcome|Placebo|Patients receiving intranasal placebo once daily
644023|NCT00416182|O1|Outcome|Pulmozyme|Patients receiving 2.5 mg intranasal Pulmozyme once daily
644024|NCT00416182|E2|Reported Event|Placebo|patients receiving once daily intranasal placebo
644025|NCT00416182|E1|Reported Event|Pulmozyme|patients receiving once daily intranasal Pulmozyme
644026|NCT00416078|B3|Baseline|Total|Total of all reporting groups
644027|NCT00416078|B2|Baseline|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year customary care
644028|NCT00416078|B1|Baseline|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
644029|NCT00416078|P2|Participant Flow|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
644030|NCT00416078|P1|Participant Flow|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
644031|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
644032|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
644033|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
644034|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
644035|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
644036|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
644037|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
644038|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
644039|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
644040|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
644041|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
644042|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
649839|NCT00402987|O4|Outcome|Placebo|
644045|NCT00415909|B1|Baseline|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
644046|NCT00415909|P1|Participant Flow|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~T Acute Lymphoblastic Leukemia/Lymphoma (TALL)-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
644047|NCT00415909|O1|Outcome|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
644048|NCT00415909|E1|Reported Event|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
644049|NCT00415870|B3|Baseline|Total|Total of all reporting groups
644050|NCT00415870|B2|Baseline|PACE: Intervention - SMS Messages and Lifestyle Counseling|Received text messages and counseling calls
644051|NCT00415870|B1|Baseline|Control: Enhanced Usual Care|Enhanced usual care
644052|NCT00415870|P2|Participant Flow|PACE|"Received text messages and counseling calls~Food Monitoring : Food Monitoring~Text Message : Text Message~Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device~Diet Goals via Cell Phone : Diet Goals via Cell Phone~Weekly Weighing : Weekly Weighing~Printed Material : Printed Material"
644053|NCT00415870|P1|Participant Flow|Control|Enhanced Usual Care
644054|NCT00415870|O2|Outcome|PACE: Intervention - SMS Messages|Received text messages and counseling calls
644055|NCT00415870|O1|Outcome|Control:Enhanced Usual Care|Enhanced Usual Care
644056|NCT00415870|E2|Reported Event|PACE|Received text messages and counseling calls
644057|NCT00415870|E1|Reported Event|Control|Enhanced Usual Care
644058|NCT00415857|B3|Baseline|Total|Total of all reporting groups
644059|NCT00415857|B2|Baseline|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
644060|NCT00415857|B1|Baseline|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
644061|NCT00415857|P2|Participant Flow|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
644062|NCT00415857|P1|Participant Flow|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
644063|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
644064|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
644065|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
644066|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
644067|NCT00415857|E2|Reported Event|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
644068|NCT00415857|E1|Reported Event|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
644069|NCT00415623|B3|Baseline|Total|Total of all reporting groups
644070|NCT00415623|B2|Baseline|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644071|NCT00415623|B1|Baseline|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644072|NCT00415623|P2|Participant Flow|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644073|NCT00415623|P1|Participant Flow|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644074|NCT00415623|O3|Outcome|Week 8|
644075|NCT00415623|O2|Outcome|Week 4|
644076|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
644077|NCT00415623|O3|Outcome|Week 8|
644078|NCT00415623|O2|Outcome|Week 4|
644079|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
644080|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644081|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644082|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644083|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644084|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644085|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644086|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644087|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644088|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644089|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644090|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644091|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644092|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644093|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644094|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
644095|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
644096|NCT00415610|B4|Baseline|Total|Total of all reporting groups
644097|NCT00415610|B3|Baseline|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644098|NCT00415610|B2|Baseline|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644099|NCT00415610|B1|Baseline|Tier 1|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644100|NCT00415610|P3|Participant Flow|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644127|NCT00415532|B3|Baseline|Total|Total of all reporting groups
645582|NCT00412958|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection
644101|NCT00415610|P2|Participant Flow|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644102|NCT00415610|P1|Participant Flow|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644103|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644104|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644105|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644106|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644107|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644108|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644109|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644110|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644128|NCT00415532|B2|Baseline|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644165|NCT00415519|O2|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644111|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644112|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644113|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644114|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644115|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644116|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644117|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644118|NCT00415610|E3|Reported Event|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
644119|NCT00415610|E2|Reported Event|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644120|NCT00415610|E1|Reported Event|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
644121|NCT00415597|B1|Baseline|ALO-01|
644122|NCT00415597|P1|Participant Flow|ALO-01|
644123|NCT00415597|O1|Outcome|ALO-01|
644124|NCT00415597|O1|Outcome|ALO-01|
644125|NCT00415597|O1|Outcome|ALO-01|
644126|NCT00415597|E1|Reported Event|ALO-01|
644129|NCT00415532|B1|Baseline|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644130|NCT00415532|P2|Participant Flow|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644131|NCT00415532|P1|Participant Flow|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644132|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644133|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644134|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644135|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644136|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644137|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644138|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644139|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644140|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644141|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644142|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644143|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644144|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644145|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644146|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
644147|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644148|NCT00415532|E2|Reported Event|AMG 531|
644149|NCT00415532|E1|Reported Event|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
644150|NCT00415519|B3|Baseline|Total|Total of all reporting groups
644151|NCT00415519|B2|Baseline|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644152|NCT00415519|B1|Baseline|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644153|NCT00415519|P2|Participant Flow|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644154|NCT00415519|P1|Participant Flow|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644155|NCT00415519|O2|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644156|NCT00415519|O1|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644157|NCT00415519|O2|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644158|NCT00415519|O1|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644159|NCT00415519|O2|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644160|NCT00415519|O1|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644161|NCT00415519|O2|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644162|NCT00415519|O1|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644163|NCT00415519|O2|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
649840|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
644166|NCT00415519|O1|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644167|NCT00415519|O2|Outcome|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644168|NCT00415519|O1|Outcome|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644169|NCT00415519|E2|Reported Event|Placebo of MCI-186|MCI-186 Injection Placebo, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644170|NCT00415519|E1|Reported Event|MCI-186|MCI-186 Injection 30 mg, 2 ampoules per treatment, once daily, intravenously infused over 60 min
644171|NCT00415506|B3|Baseline|Total|Total of all reporting groups
644172|NCT00415506|B2|Baseline|Orbital Inflammation|Subjects with Orbital Inflammation
644173|NCT00415506|B1|Baseline|Scleritis|Subjects with Scleritis
644174|NCT00415506|P2|Participant Flow|Orbital Inflammation|Patients with non-infectious orbital inflammatory disease, and is a phase I, prospective clinical trial to examine the safety of the 2 infusions of rituximab intravenously, 2 weeks apart, in the treatment of non-infectious orbital inflammation. The first 5 patients will receive 1000 mg of rituximab at each infusion, any additional patients will be randomized to receive either 500 mg or 1000 mg of rituximab.
644175|NCT00415506|P1|Participant Flow|Scleritis|Patients with non-infectious scleritis and is a phase II, randomized, double-blinded, prospective clinical trial of two different doses of rituximab to compare the safety and efficacy of these 2 doses. Patients will be randomized to either 500 mg or 1000 mg of rituximab administered intravenously two weeks apart.
644176|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
644177|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
644178|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
644179|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
644180|NCT00415506|E2|Reported Event|Scleritis|Subjects with Scleritis
644181|NCT00415506|E1|Reported Event|Orbital Inflammation|Subjects with Orbital Inflammation
644182|NCT00415493|B3|Baseline|Total|Total of all reporting groups
644183|NCT00415493|B2|Baseline|Controls|normal subjects
644184|NCT00415493|B1|Baseline|Cases|non-allergic rhinitis subjects
644185|NCT00415493|P2|Participant Flow|Warm-moist Air Followed by Cold-dry Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Warm-moist air followed (on a separate day) by Cold-dry air. Exposures lasted 15 minutes, with a one-hour follow-up period.
644186|NCT00415493|P1|Participant Flow|Cold-dry Air Followed by Warm-moist Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Cold-dry air followed (on a separate day) by Warm-moist air. Exposures lasted 15 minutes, with a one-hour follow-up period.
644187|NCT00415493|O2|Outcome|Controls|normal subjects
644188|NCT00415493|O1|Outcome|Cases|non-allergic rhinitis subjects
644189|NCT00415493|E2|Reported Event|Controls|normal subjects
644190|NCT00415493|E1|Reported Event|Cases|non-allergic rhinitis subjects
644191|NCT00415194|B3|Baseline|Total|Total of all reporting groups
644192|NCT00415194|B2|Baseline|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644193|NCT00415194|B1|Baseline|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644194|NCT00415194|P2|Participant Flow|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644195|NCT00415194|P1|Participant Flow|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644196|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644257|NCT00414908|O1|Outcome|Pancrelipase (OL)|Pancrelipase delayed during Open-label. Dosing is directed by the investigator.
644258|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644259|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644197|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644198|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644199|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644200|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644201|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644202|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644203|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644204|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644205|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644206|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644207|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
644260|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644261|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644262|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644208|NCT00415194|E2|Reported Event|Placebo/Cisplatin|Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
644209|NCT00415194|E1|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
644210|NCT00415168|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644211|NCT00415168|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644212|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644213|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644214|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644215|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644216|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644217|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644218|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644219|NCT00415168|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
644220|NCT00415051|B1|Baseline|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
644221|NCT00415051|P1|Participant Flow|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
644222|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
644223|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
644224|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
644225|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
644226|NCT00415051|E1|Reported Event|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
644227|NCT00414973|B5|Baseline|Total|Total of all reporting groups
644228|NCT00414973|B4|Baseline|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
644229|NCT00414973|B3|Baseline|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
644230|NCT00414973|B2|Baseline|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
644231|NCT00414973|B1|Baseline|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
644232|NCT00414973|P4|Participant Flow|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
644233|NCT00414973|P3|Participant Flow|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
644234|NCT00414973|P2|Participant Flow|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
644235|NCT00414973|P1|Participant Flow|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
644236|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
644237|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
644238|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
644239|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
644240|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
644241|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
644242|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
644243|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
644244|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
644245|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
644246|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
644247|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
644248|NCT00414973|E4|Reported Event|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
644249|NCT00414973|E3|Reported Event|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
644250|NCT00414973|E2|Reported Event|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
644251|NCT00414973|E1|Reported Event|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
644252|NCT00414908|B3|Baseline|Total|Total of all reporting groups
644253|NCT00414908|B2|Baseline|Placebo (DB)|Placebo group given during the Double-Blind period
644254|NCT00414908|B1|Baseline|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644255|NCT00414908|P2|Participant Flow|Placebo (DB)|Placebo group given during the Double-Blind period
644256|NCT00414908|P1|Participant Flow|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644290|NCT00414726|B3|Baseline|Total|Total of all reporting groups
644263|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644264|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644265|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644266|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644267|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644268|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644269|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644270|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644271|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644272|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
644273|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
644274|NCT00414908|E3|Reported Event|Pancrelipase (OL)|Pancrelipase delayed capsules received by the patients during the 6-month Open Label. The dosing was directed by the investigator.
644275|NCT00414908|E2|Reported Event|Placebo (DB)|Placebo group meaning the treatment received during the 7-days double-blind period
644276|NCT00414908|E1|Reported Event|Pancrelipase (DB)|Pancrelipase delayed release capsules meaning the treatment received during the 7-days double-blind period
644277|NCT00414817|B3|Baseline|Total|Total of all reporting groups
644278|NCT00414817|B2|Baseline|Usual Care|usual care participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
644279|NCT00414817|B1|Baseline|Automated Phone-Based Refill Reminders|Intervention arm participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
644280|NCT00414817|P2|Participant Flow|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
644281|NCT00414817|P1|Participant Flow|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
644282|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
644283|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
644284|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
644285|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
644286|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
644287|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
644288|NCT00414817|E2|Reported Event|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
644289|NCT00414817|E1|Reported Event|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
644294|NCT00414726|P1|Participant Flow|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
644295|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
644296|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
644297|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
644298|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
644299|NCT00414726|E2|Reported Event|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
644300|NCT00414726|E1|Reported Event|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
644301|NCT00414700|B3|Baseline|Total|Total of all reporting groups
644302|NCT00414700|B2|Baseline|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644303|NCT00414700|B1|Baseline|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644304|NCT00414700|P2|Participant Flow|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644305|NCT00414700|P1|Participant Flow|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644306|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644307|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644308|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644309|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644310|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644311|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644312|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644313|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644314|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644315|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644316|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644317|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644318|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644319|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644320|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644321|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644322|NCT00414700|E2|Reported Event|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
644323|NCT00414700|E1|Reported Event|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
644325|NCT00414661|B4|Baseline|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
644326|NCT00414661|B3|Baseline|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
644327|NCT00414661|B2|Baseline|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
644328|NCT00414661|B1|Baseline|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
644329|NCT00414661|P4|Participant Flow|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
644330|NCT00414661|P3|Participant Flow|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
644331|NCT00414661|P2|Participant Flow|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
644332|NCT00414661|P1|Participant Flow|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
644333|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
644334|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
644335|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
644336|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
644337|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
644338|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
644339|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
644340|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
644341|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
644342|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
644343|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
644344|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
644345|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
644346|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
644347|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
644348|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
644349|NCT00414661|E4|Reported Event|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
644350|NCT00414661|E3|Reported Event|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
644351|NCT00414661|E2|Reported Event|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
644352|NCT00414661|E1|Reported Event|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
644353|NCT00414635|B3|Baseline|Total|Total of all reporting groups
644354|NCT00414635|B2|Baseline|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644355|NCT00414635|B1|Baseline|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644356|NCT00414635|P2|Participant Flow|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644357|NCT00414635|P1|Participant Flow|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644358|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644359|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644360|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644361|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
645130|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
644362|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644363|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644364|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644365|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644366|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644367|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644368|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644369|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644370|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644371|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644372|NCT00414635|E2|Reported Event|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
644373|NCT00414635|E1|Reported Event|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
644374|NCT00414609|B3|Baseline|Total|Total of all reporting groups
644375|NCT00414609|B2|Baseline|Aliskiren|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644376|NCT00414609|B1|Baseline|Placebo|Placebo for 36 weeks once daily in the morning
644377|NCT00414609|P3|Participant Flow|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
644378|NCT00414609|P2|Participant Flow|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644379|NCT00414609|P1|Participant Flow|Placebo_Core|Placebo for 36 weeks once daily in the morning
644380|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
644381|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
644382|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
644383|NCT00414609|O1|Outcome|Aliskiren_Extension|150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study.
644384|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
644385|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
644386|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644387|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
644388|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644389|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
644390|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644391|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
644392|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644393|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
644394|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644395|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
644396|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644397|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
644398|NCT00414609|E3|Reported Event|Aliskiren_extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
644399|NCT00414609|E2|Reported Event|Aliskiren_core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
644400|NCT00414609|E1|Reported Event|Placebo_core|Placebo for 36 weeks once daily in the morning
644401|NCT00414596|B1|Baseline|DRX Group|Patients using the device DRX9000™.
644402|NCT00414596|P1|Participant Flow|DRX Group|Patients using the device DRX9000™.
644403|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
644404|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
644405|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
644406|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
644407|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
644408|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
644409|NCT00414596|E1|Reported Event|DRX Group|Patients using the device DRX9000™.
644410|NCT00414544|B1|Baseline|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
644411|NCT00414544|P1|Participant Flow|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
644412|NCT00414544|O2|Outcome|Restylane (Control)|Restylane (Control) injected nasolabial fold contralateral side
644413|NCT00414544|O1|Outcome|CosmetaLife|CosmetaLife injected nasolabial fold side
644414|NCT00414544|E2|Reported Event|Restylane (Control)|
644415|NCT00414544|E1|Reported Event|CosmetaLife|
644416|NCT00414518|B3|Baseline|Total|Total of all reporting groups
644417|NCT00414518|B2|Baseline|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
644418|NCT00414518|B1|Baseline|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
644419|NCT00414518|P2|Participant Flow|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
644420|NCT00414518|P1|Participant Flow|Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
644421|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
644422|NCT00414518|O1|Outcome|12 Week Treatment Folllowed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
644423|NCT00414518|O2|Outcome|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
644424|NCT00414518|O1|Outcome|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
644425|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapyh|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
644426|NCT00414518|O1|Outcome|12 Week Treatment Arm Followed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
644427|NCT00414518|E2|Reported Event|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
644428|NCT00414518|E1|Reported Event|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
644429|NCT00414466|B5|Baseline|Total|Total of all reporting groups
644430|NCT00414466|B4|Baseline|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644431|NCT00414466|B3|Baseline|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644432|NCT00414466|B2|Baseline|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644433|NCT00414466|B1|Baseline|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
644434|NCT00414466|P4|Participant Flow|4 Gabapentin High (30mg/Day)|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644435|NCT00414466|P3|Participant Flow|3 Gabapentin Medium (6mg/Day)|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644436|NCT00414466|P2|Participant Flow|2 Gabapentin Low (1mg/Day)|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644437|NCT00414466|P1|Participant Flow|1 Placebo (0mg/Day)|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
644438|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644439|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644440|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644441|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
644442|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644443|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644444|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644445|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
644446|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644447|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644448|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644449|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
644450|NCT00414466|E4|Reported Event|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644451|NCT00414466|E3|Reported Event|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644452|NCT00414466|E2|Reported Event|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
644453|NCT00414466|E1|Reported Event|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
644454|NCT00414453|B1|Baseline|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644455|NCT00414453|P1|Participant Flow|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644456|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644457|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644491|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644458|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644459|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644460|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644461|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644462|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644463|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644464|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644465|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644466|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644467|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644468|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644469|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644470|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644471|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644472|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644473|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644474|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644475|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644476|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644477|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644478|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644479|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644480|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644481|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644482|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644483|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644484|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644485|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644486|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644487|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644488|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644489|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644490|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644492|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644493|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644494|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644495|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644496|NCT00414453|E4|Reported Event|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
644497|NCT00414453|E3|Reported Event|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
644498|NCT00414453|E2|Reported Event|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
644499|NCT00414453|E1|Reported Event|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
644500|NCT00414440|B3|Baseline|Total|Total of all reporting groups
644501|NCT00414440|B2|Baseline|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
644502|NCT00414440|B1|Baseline|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644503|NCT00414440|P2|Participant Flow|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
644504|NCT00414440|P1|Participant Flow|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644505|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
644506|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644507|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
644508|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644509|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
644510|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644511|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
644512|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644513|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
644514|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644515|NCT00414440|E2|Reported Event|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses
644516|NCT00414440|E1|Reported Event|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
644517|NCT00414388|B1|Baseline|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
644518|NCT00414388|P1|Participant Flow|Single Agent Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m^2 and mitoxantrone was given at 12 mg/m^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.
644519|NCT00414388|O1|Outcome|Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (Docetaxel or Mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m2 and Mitoxantrone was given at 12 mg/m2, both once every 21 days and both combined with Prednisone at 5mg twice daily. A maximum of 6 cycles of Sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive Sorafenib monotherapy until disease progression.
644520|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
644521|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
644522|NCT00414388|E1|Reported Event|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
644523|NCT00414310|B3|Baseline|Total|Total of all reporting groups
644524|NCT00414310|B2|Baseline|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
644525|NCT00414310|B1|Baseline|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
644526|NCT00414310|P2|Participant Flow|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
644527|NCT00414310|P1|Participant Flow|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
644528|NCT00414310|O2|Outcome|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
644529|NCT00414310|O1|Outcome|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
644530|NCT00414310|E2|Reported Event|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
644531|NCT00414310|E1|Reported Event|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
644532|NCT00414206|B4|Baseline|Total|Total of all reporting groups
644533|NCT00414206|B3|Baseline|Placebo|
644534|NCT00414206|B2|Baseline|0.3% Mecamylamine|
644535|NCT00414206|B1|Baseline|1% Mecamylamine|
644536|NCT00414206|P3|Participant Flow|Placebo|
644537|NCT00414206|P2|Participant Flow|0.3% Mecamylamine|
644538|NCT00414206|P1|Participant Flow|1% Mecamylamine|
644539|NCT00414206|O3|Outcome|Placebo|
644540|NCT00414206|O2|Outcome|0.3% Mecamylamine|
644541|NCT00414206|O1|Outcome|1% Mecamylamine|
644542|NCT00414206|E3|Reported Event|Placebo|
644543|NCT00414206|E2|Reported Event|0.3% Mecamylamine|
644544|NCT00414206|E1|Reported Event|1% Mecamylamine|
644545|NCT00414167|B3|Baseline|Total|Total of all reporting groups
644546|NCT00414167|B2|Baseline|Placebo|"Placebo~Placebo : Placebo"
644547|NCT00414167|B1|Baseline|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
644548|NCT00414167|P2|Participant Flow|Placebo|"Placebo~Placebo : Placebo"
644549|NCT00414167|P1|Participant Flow|Bupropion (300 mg/d)|"Bupropion~bupropion : 300 mg per day for 8 weeks"
644550|NCT00414167|O2|Outcome|Placebo|"Placebo~Placebo : Placebo"
644551|NCT00414167|O1|Outcome|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
644552|NCT00414167|O2|Outcome|Placebo|
644553|NCT00414167|O1|Outcome|Bupropion|
644554|NCT00414167|E2|Reported Event|Placebo|
644555|NCT00414167|E1|Reported Event|Bupropion|
644556|NCT00414050|B5|Baseline|Total|Total of all reporting groups
644557|NCT00414050|B4|Baseline|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644558|NCT00414050|B3|Baseline|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644559|NCT00414050|B2|Baseline|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644560|NCT00414050|B1|Baseline|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644561|NCT00414050|P4|Participant Flow|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644562|NCT00414050|P3|Participant Flow|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644563|NCT00414050|P2|Participant Flow|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644564|NCT00414050|P1|Participant Flow|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644565|NCT00414050|O4|Outcome|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644566|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644567|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644568|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644569|NCT00414050|O4|Outcome|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644570|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644571|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644572|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644573|NCT00414050|E4|Reported Event|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644574|NCT00414050|E3|Reported Event|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
644575|NCT00414050|E2|Reported Event|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644576|NCT00414050|E1|Reported Event|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
644577|NCT00414011|B1|Baseline|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
644726|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644578|NCT00414011|P1|Participant Flow|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
644579|NCT00414011|O2|Outcome|Gatifloxacin|Gatifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
644580|NCT00414011|O1|Outcome|Moxifloxacin|Moxifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
644581|NCT00414011|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
644582|NCT00413972|B5|Baseline|Total|Total of all reporting groups
644583|NCT00413972|B4|Baseline|Placebo|
644584|NCT00413972|B3|Baseline|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
644585|NCT00413972|B2|Baseline|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
644586|NCT00413972|B1|Baseline|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
644587|NCT00413972|P4|Participant Flow|Placebo|
644588|NCT00413972|P3|Participant Flow|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
644589|NCT00413972|P2|Participant Flow|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
644590|NCT00413972|P1|Participant Flow|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
644591|NCT00413972|O4|Outcome|Placebo|
644592|NCT00413972|O3|Outcome|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
644593|NCT00413972|O2|Outcome|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
644594|NCT00413972|O1|Outcome|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
644595|NCT00413972|E4|Reported Event|Placebo|
644596|NCT00413972|E3|Reported Event|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
644597|NCT00413972|E2|Reported Event|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
644598|NCT00413972|E1|Reported Event|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
644599|NCT00413959|B1|Baseline|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
644600|NCT00413959|P1|Participant Flow|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
644601|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
644602|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
644603|NCT00413959|E1|Reported Event|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
644604|NCT00413920|B3|Baseline|Total|Total of all reporting groups
644605|NCT00413920|B2|Baseline|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644606|NCT00413920|B1|Baseline|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644607|NCT00413920|P2|Participant Flow|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644608|NCT00413920|P1|Participant Flow|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644609|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644610|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644611|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644612|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644613|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644614|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644615|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644616|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644617|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644618|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644619|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644620|NCT00413920|E2|Reported Event|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
644621|NCT00413920|E1|Reported Event|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
644622|NCT00413894|B1|Baseline|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644623|NCT00413894|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)|During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant’s hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644624|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644625|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644626|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644627|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644628|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644629|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644630|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644825|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644631|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644632|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644633|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644634|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644635|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644636|NCT00413894|E1|Reported Event|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
644637|NCT00413777|B3|Baseline|Total|Total of all reporting groups
644638|NCT00413777|B2|Baseline|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644639|NCT00413777|B1|Baseline|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644640|NCT00413777|P2|Participant Flow|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644641|NCT00413777|P1|Participant Flow|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644642|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644643|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644644|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644645|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644646|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644647|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644648|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644649|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644650|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644651|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644652|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644653|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644654|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644655|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644656|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644657|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644658|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644659|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644660|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644661|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644662|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644663|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644664|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644665|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644666|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644667|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644668|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644669|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644670|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644671|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644672|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644673|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644674|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644675|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644676|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644677|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644678|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644679|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644680|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644681|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644913|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644682|NCT00413777|O2|Outcome|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644683|NCT00413777|O1|Outcome|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644684|NCT00413777|E2|Reported Event|Tolvaptan 60+30 mg|Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644685|NCT00413777|E1|Reported Event|Tolvaptan 45+15 mg|Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months.
644686|NCT00413699|B3|Baseline|Total|Total of all reporting groups
644687|NCT00413699|B2|Baseline|Tofacitinib 10 mg BID|Participants with average total daily dose across study >/=15 were assigned to 10 mg BID
644688|NCT00413699|B1|Baseline|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average daily dose across study <15 were assigned to 5 mg BID
644689|NCT00413699|P2|Participant Flow|Tofacitinib 10 mg BID|Participants with average total daily dose across study >/=15 were assigned to 10 mg BID
644690|NCT00413699|P1|Participant Flow|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644691|NCT00413699|O6|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644692|NCT00413699|O5|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
644693|NCT00413699|O4|Outcome|Tofacitinib 10 mg BID Interrupted Visit 3|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644694|NCT00413699|O3|Outcome|Tofacitinib 10 mg BID Continuous Visit 3|Participants receiving continuous tofacitinib treatment
644695|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted Visit 2|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644696|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous Visit 2|Participants receiving continuous tofacitinib treatment
644697|NCT00413699|O6|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Patients whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644698|NCT00413699|O5|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
644699|NCT00413699|O4|Outcome|Tofacitinib 10 mg BID Interrupted Visit 3|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644700|NCT00413699|O3|Outcome|Tofacitinib 10 mg BID Continuous Visit 3|Participants receiving continuous tofacitinib treatment
644701|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted Visit 2|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644702|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous Visit 2|Participants receiving continuous tofacitinib treatment
644703|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644704|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous|Participants receiving continuous tofacitinib treatment
644705|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644706|NCT00413699|O1|Outcome|Tofacitinib 10 mg Continuous|Participants receiving continuous tofacitinib treatment
644707|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644708|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
644709|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644710|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous|Participants receiving continuous tofacitinib treatment
644711|NCT00413699|O4|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644712|NCT00413699|O3|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
644713|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted Visit 3|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644714|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous Visit 3|Participants receiving continuous tofacitinib treatment
644715|NCT00413699|O4|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644716|NCT00413699|O3|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
644717|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted Visit 3|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644718|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous Visit 3|Participants receiving continuous tofacitinib treatment
644719|NCT00413699|O4|Outcome|Tofacitinib 10 mg BID Interrupted Visit 4|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644720|NCT00413699|O3|Outcome|Tofacitinib 10 mg BID Continuous Visit 4|Participants receiving continuous tofacitinib treatment
644721|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID Interrupted Visit 3|Participants whose treatment with tofacitinib was interrupted for 2 weeks post-randomization
644722|NCT00413699|O1|Outcome|Tofacitinib 10 mg BID Continuous Visit 3|Participants receiving continuous tofacitinib treatment
644723|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644724|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644725|NCT00413699|O1|Outcome|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
649841|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
644727|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644728|NCT00413699|O1|Outcome|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644729|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644730|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644731|NCT00413699|O1|Outcome|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644732|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644733|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644734|NCT00413699|O1|Outcome|Tofacitinib 5 Milligram (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644735|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644736|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644737|NCT00413699|O1|Outcome|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644738|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644739|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644740|NCT00413699|O1|Outcome|Tofacitinib 5 Milligram (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644741|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644742|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644743|NCT00413699|O1|Outcome|Tofacitinib 5 Milligram (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644744|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644745|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644746|NCT00413699|O1|Outcome|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644747|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644748|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644749|NCT00413699|O1|Outcome|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644750|NCT00413699|O3|Outcome|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644751|NCT00413699|O2|Outcome|Tofacitinib 10 mg BID|Participants with average total daily dose across study ≥15 were assigned to 10 mg BID
644752|NCT00413699|O1|Outcome|Tofacitinib 5 Milligrams (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644753|NCT00413699|E3|Reported Event|All Tofacitinib|All participants treated with tofacitinib from 5 mg BID and 10 mg BID groups
644754|NCT00413699|E2|Reported Event|Tofacitinib 10 mg BID|Participants with average total daily dose across study >/=15 were assigned to 10 mg BID
644755|NCT00413699|E1|Reported Event|Tofacitinib 5 Milligram (mg) Twice Daily (BID)|Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
644756|NCT00413660|B8|Baseline|Total|Total of all reporting groups
644757|NCT00413660|B7|Baseline|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644758|NCT00413660|B6|Baseline|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644759|NCT00413660|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644760|NCT00413660|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644761|NCT00413660|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644762|NCT00413660|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644763|NCT00413660|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644764|NCT00413660|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644765|NCT00413660|P10|Participant Flow|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644766|NCT00413660|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645001|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644767|NCT00413660|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644768|NCT00413660|P7|Participant Flow|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644769|NCT00413660|P6|Participant Flow|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644770|NCT00413660|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644771|NCT00413660|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644772|NCT00413660|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644773|NCT00413660|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644774|NCT00413660|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644775|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644776|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644777|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644778|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644779|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644780|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644781|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644782|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644783|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644784|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644785|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644786|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644787|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644788|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644789|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644790|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644791|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644792|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644793|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644794|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644795|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645125|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
644796|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644797|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644798|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644799|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644800|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644801|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644802|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644803|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644804|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644805|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644806|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644807|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644808|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644809|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644810|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644811|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644812|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644813|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644814|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644815|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644816|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644817|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644818|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644819|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644820|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644821|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644822|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644823|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644824|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
649842|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
644826|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644827|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644828|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644829|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644830|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644831|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644832|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644833|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644834|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644835|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644836|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644837|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644838|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644839|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644840|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644841|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644842|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644843|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644844|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644845|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644846|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644847|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644848|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644849|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644850|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644851|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644852|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644853|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645126|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
644854|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644855|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644856|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644857|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644858|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644859|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644860|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644861|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644862|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644863|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644864|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644865|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644866|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644867|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644868|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644869|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644870|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644871|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644872|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644873|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644874|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644875|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644876|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644877|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644878|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644879|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644880|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644881|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644882|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644883|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644884|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644885|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644886|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644887|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644888|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644889|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644890|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644891|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644892|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644893|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644894|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644895|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644896|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644897|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644898|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644899|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644900|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644901|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644902|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644903|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644904|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644905|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644906|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644907|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644908|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644909|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644910|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644911|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644912|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
649843|NCT00402987|O3|Outcome|Placebo|
644914|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644915|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644916|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644917|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644918|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644919|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644920|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644921|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644922|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644923|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644924|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644925|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644926|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644927|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644928|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644929|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644930|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644931|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644932|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644933|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644934|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644935|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644936|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644937|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644938|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644939|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644940|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644941|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645127|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
644942|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644943|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644944|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644945|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644946|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644947|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644948|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644949|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644950|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644951|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644952|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644953|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644954|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644955|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644956|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644957|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644958|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644959|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644960|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644961|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644962|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644963|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644964|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644965|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644966|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644967|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644968|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644969|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644970|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644971|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644972|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644973|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644974|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644975|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644976|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644977|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644978|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644979|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644980|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644981|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644982|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644983|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644984|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644985|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644986|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644987|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644988|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
644989|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
644990|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
644991|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644992|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
644993|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644994|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
644995|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644996|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
644997|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
644998|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
644999|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645000|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
649844|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
645002|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645003|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645004|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645005|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645006|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645007|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645008|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645009|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645010|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645011|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645012|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645013|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645014|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645015|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645016|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645017|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645018|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645019|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645020|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645021|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645022|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645023|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645024|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645025|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645026|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645027|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645028|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645029|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645128|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
645030|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645031|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645032|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645033|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645034|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645035|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645036|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645037|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645038|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645039|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645040|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645041|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645042|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645043|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645044|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645045|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645046|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645047|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645048|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645049|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645050|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645051|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645052|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645053|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645054|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645055|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645056|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645057|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645058|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645059|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645060|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645061|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645062|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645063|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645064|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645065|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645066|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645067|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645068|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645069|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645070|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645071|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645072|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645073|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645074|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645075|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645076|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645077|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645078|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645079|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645080|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645081|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645082|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645083|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645084|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645085|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645086|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645087|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645088|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645129|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
645089|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645090|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645091|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645092|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645093|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645094|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645095|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645096|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645097|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645098|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645099|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
645100|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645101|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
645102|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
645103|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
645104|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
645105|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
645106|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
645107|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
645108|NCT00413660|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
645109|NCT00413660|E10|Reported Event|Placebo|Matching placebo tablet orally twice daily up to Week 24.
645110|NCT00413660|E9|Reported Event|CP-690,550 20 mg to CP-690,550 5 mg (R)|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24.
645111|NCT00413660|E8|Reported Event|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24.
645112|NCT00413660|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24.
645113|NCT00413660|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24.
645114|NCT00413660|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24.
645115|NCT00413660|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
645116|NCT00413660|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24.
645117|NCT00413660|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
645118|NCT00413660|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24.
645119|NCT00413634|B3|Baseline|Total|Total of all reporting groups
645120|NCT00413634|B2|Baseline|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645121|NCT00413634|B1|Baseline|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645122|NCT00413634|P2|Participant Flow|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645123|NCT00413634|P1|Participant Flow|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645124|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645132|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
645133|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
645134|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
645135|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
645136|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
645137|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
645138|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
645139|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
645140|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645141|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645142|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645143|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645144|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645145|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645146|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645147|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645148|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645149|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645150|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645151|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645152|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645153|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645154|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645155|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645156|NCT00413634|E2|Reported Event|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
645157|NCT00413634|E1|Reported Event|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
645158|NCT00413582|B3|Baseline|Total|Total of all reporting groups
645159|NCT00413582|B2|Baseline|PCA Group|IV narcotic analgesia arm of study
645160|NCT00413582|B1|Baseline|Epidural Group|Epidural analgesia arm of study
645161|NCT00413582|P2|Participant Flow|PCA Group|IV narcotic analgesia arm of study
645162|NCT00413582|P1|Participant Flow|Epidural Group|Epidural analgesia arm of study
645163|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
645164|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
645165|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
645166|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
645167|NCT00413582|E2|Reported Event|PCA Group|IV narcotic analgesia arm of study
645168|NCT00413582|E1|Reported Event|Epidural Group|Epidural analgesia arm of study
645169|NCT00413478|B1|Baseline|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
645170|NCT00413478|P1|Participant Flow|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
645171|NCT00413478|O1|Outcome|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
645172|NCT00413478|E1|Reported Event|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
645173|NCT00413413|B4|Baseline|Total|Total of all reporting groups
645174|NCT00413413|B3|Baseline|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645175|NCT00413413|B2|Baseline|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645176|NCT00413413|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645177|NCT00413413|P3|Participant Flow|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645178|NCT00413413|P2|Participant Flow|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645179|NCT00413413|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645180|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645181|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645182|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645183|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645184|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645185|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645186|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645187|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645188|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645189|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645190|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645191|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645192|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645193|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645194|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645195|NCT00413413|E3|Reported Event|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645196|NCT00413413|E2|Reported Event|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
645197|NCT00413413|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
645198|NCT00413400|B3|Baseline|Total|Total of all reporting groups
645199|NCT00413400|B2|Baseline|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645200|NCT00413400|B1|Baseline|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645201|NCT00413400|P2|Participant Flow|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645202|NCT00413400|P1|Participant Flow|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645203|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645204|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645205|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645206|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645207|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645208|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645209|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645210|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645211|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645212|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645213|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645214|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645215|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645216|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645217|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645218|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645219|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645220|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645221|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645222|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645223|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645224|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645225|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645226|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645227|NCT00413400|E2|Reported Event|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
645228|NCT00413400|E1|Reported Event|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
645229|NCT00413374|B1|Baseline|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
645230|NCT00413374|P1|Participant Flow|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
645231|NCT00413374|O1|Outcome|Recurrent Venous Thromboembolism|Participants receiving Enoxaparin once daily who developed a VTE (either a DVT or PE) within 30 days.
645232|NCT00413374|O1|Outcome|Major Bleeding Complication|Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.
645233|NCT00413374|E1|Reported Event|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
645234|NCT00413335|B3|Baseline|Total|Total of all reporting groups
645235|NCT00413335|B2|Baseline|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645236|NCT00413335|B1|Baseline|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645237|NCT00413335|P2|Participant Flow|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645238|NCT00413335|P1|Participant Flow|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645239|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645240|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645241|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645242|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645243|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645244|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645245|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645246|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645247|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645248|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645249|NCT00413335|E2|Reported Event|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
645250|NCT00413335|E1|Reported Event|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
645251|NCT00413283|B5|Baseline|Total|Total of all reporting groups
645252|NCT00413283|B4|Baseline|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645253|NCT00413283|B3|Baseline|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645254|NCT00413283|B2|Baseline|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645255|NCT00413283|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645256|NCT00413283|P4|Participant Flow|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645583|NCT00412958|P4|Participant Flow|Placebo|Intravitreal injection of placebo.
645257|NCT00413283|P3|Participant Flow|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645258|NCT00413283|P2|Participant Flow|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645259|NCT00413283|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645260|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645261|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645262|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645263|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645264|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645265|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645266|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645267|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645268|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645269|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645270|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645271|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645344|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645584|NCT00412958|P3|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
645272|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645273|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645274|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645275|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645276|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645277|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645278|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645279|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645280|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645281|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645282|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645283|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645284|NCT00413283|E4|Reported Event|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645285|NCT00413283|E3|Reported Event|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645286|NCT00413283|E2|Reported Event|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645345|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645585|NCT00412958|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
645287|NCT00413283|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
645288|NCT00413244|B3|Baseline|Total|Total of all reporting groups
645289|NCT00413244|B2|Baseline|Placebo|Matching Placebo
645290|NCT00413244|B1|Baseline|Androgel|Androgel 5 grams
645291|NCT00413244|P2|Participant Flow|Placebo|Matching Placebo
645292|NCT00413244|P1|Participant Flow|Androgel|Androgel 5 grams
645293|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645294|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645295|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645296|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645297|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645298|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645299|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645300|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645301|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645302|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645303|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645304|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645305|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645306|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645307|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645308|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645309|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645310|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645311|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645312|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645313|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645314|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645315|NCT00413244|O2|Outcome|Placebo|Matching Placebo
645316|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
645317|NCT00413244|E2|Reported Event|Placebo|Matching Placebo
645318|NCT00413244|E1|Reported Event|Androgel|Androgel 5 grams
645319|NCT00413231|B1|Baseline|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645320|NCT00413231|P1|Participant Flow|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645321|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645322|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645323|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645324|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645325|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645326|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645327|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645328|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645329|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645330|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645331|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645332|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645333|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645334|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645335|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645336|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645337|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645338|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645339|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645340|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645341|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645342|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645343|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
649845|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
645346|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study.~Valiant Thoracic Stent Graft System: Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm)."
645347|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
645348|NCT00413231|E1|Reported Event|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study."
645349|NCT00413218|B3|Baseline|Total|Total of all reporting groups
645350|NCT00413218|B2|Baseline|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645351|NCT00413218|B1|Baseline|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645352|NCT00413218|P2|Participant Flow|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645353|NCT00413218|P1|Participant Flow|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645354|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645355|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645356|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645357|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645358|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645359|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic participants could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.
645360|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645361|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645362|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645363|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645364|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645365|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645366|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645367|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645368|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645369|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645370|NCT00413218|O2|Outcome|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645371|NCT00413218|O1|Outcome|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
645372|NCT00413218|E2|Reported Event|Caspofungin (CAS)/Voriconazole|Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight > 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
645373|NCT00413218|E1|Reported Event|Isavuconazole (ISA)|Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.
645374|NCT00413192|B5|Baseline|Total|Total of all reporting groups
645375|NCT00413192|B4|Baseline|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645376|NCT00413192|B3|Baseline|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645377|NCT00413192|B2|Baseline|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645378|NCT00413192|B1|Baseline|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645379|NCT00413192|P4|Participant Flow|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645449|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645586|NCT00412958|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
645380|NCT00413192|P3|Participant Flow|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645381|NCT00413192|P2|Participant Flow|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645382|NCT00413192|P1|Participant Flow|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645383|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645384|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645385|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645386|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645387|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645388|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645389|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645390|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645391|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645392|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645393|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645394|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645395|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
649846|NCT00402987|O4|Outcome|Placebo|
645396|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645397|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645398|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645399|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645400|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645401|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645402|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645403|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645404|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645405|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645406|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645407|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645408|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645409|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645410|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645411|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645568|NCT00412971|B1|Baseline|Hexvix Cystoscopy Group|
645412|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645413|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645414|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645415|NCT00413192|E4|Reported Event|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645416|NCT00413192|E3|Reported Event|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645417|NCT00413192|E2|Reported Event|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645418|NCT00413192|E1|Reported Event|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
645419|NCT00413153|B3|Baseline|Total|Total of all reporting groups
645420|NCT00413153|B2|Baseline|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645421|NCT00413153|B1|Baseline|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645422|NCT00413153|P2|Participant Flow|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645423|NCT00413153|P1|Participant Flow|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645424|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645425|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645426|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645427|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645428|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645429|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645430|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645431|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645432|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645433|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645434|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645435|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645436|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645437|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645438|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645439|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645440|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645441|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645442|NCT00413153|E2|Reported Event|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
645443|NCT00413153|E1|Reported Event|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
645444|NCT00413062|B3|Baseline|Total|Total of all reporting groups
645445|NCT00413062|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645446|NCT00413062|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645447|NCT00413062|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645448|NCT00413062|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645450|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645451|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645452|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645453|NCT00413062|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
645454|NCT00413062|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
645455|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645456|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645457|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645458|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645459|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645460|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645461|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645462|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645463|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645464|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645465|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645466|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645467|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645468|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645469|NCT00413062|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645470|NCT00413062|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
645471|NCT00413049|B3|Baseline|Total|Total of all reporting groups
645587|NCT00412958|O4|Outcome|Placebo|Intravitreal injection of placebo.
645472|NCT00413049|B2|Baseline|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645473|NCT00413049|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645474|NCT00413049|P2|Participant Flow|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645475|NCT00413049|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645476|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645477|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645478|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645479|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645480|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645481|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645482|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645483|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645484|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645485|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645486|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645487|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645488|NCT00413049|E2|Reported Event|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645489|NCT00413049|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
645490|NCT00413036|B1|Baseline|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645491|NCT00413036|P1|Participant Flow|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645492|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645493|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645494|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645495|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645496|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645497|NCT00413036|E1|Reported Event|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
645498|NCT00413010|B3|Baseline|Total|Total of all reporting groups
645499|NCT00413010|B2|Baseline|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
649847|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
645500|NCT00413010|B1|Baseline|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645501|NCT00413010|P2|Participant Flow|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645502|NCT00413010|P1|Participant Flow|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645503|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645504|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645505|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645506|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645507|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645508|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645509|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645510|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645511|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645512|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645513|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645514|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645515|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645516|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645517|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645569|NCT00412971|P2|Participant Flow|White Light|Standard White light cystoscopy
645570|NCT00412971|P1|Participant Flow|Hexvix Cystoscopy Group|
645571|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
645572|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
645518|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645519|NCT00413010|E2|Reported Event|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645520|NCT00413010|E1|Reported Event|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
645521|NCT00412984|B3|Baseline|Total|Total of all reporting groups
645522|NCT00412984|B2|Baseline|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645523|NCT00412984|B1|Baseline|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645524|NCT00412984|P2|Participant Flow|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645525|NCT00412984|P1|Participant Flow|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645526|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645527|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645528|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645529|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645530|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645531|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645532|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645533|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645573|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
645574|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
645575|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
645576|NCT00412971|E2|Reported Event|White Light|Standard White light cystoscopy
645534|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645535|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645536|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645537|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645538|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645539|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645540|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645541|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645542|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645543|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645544|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645545|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645546|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645547|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645548|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645577|NCT00412971|E1|Reported Event|Hexvix Cystoscopy Group|
645578|NCT00412958|B5|Baseline|Total|Total of all reporting groups
645579|NCT00412958|B4|Baseline|Placebo|Intravitreal injection of placebo.
645580|NCT00412958|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
645549|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645550|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645551|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645552|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645553|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645554|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645555|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645556|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645557|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645558|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645559|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645560|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645561|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645562|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
645563|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
645564|NCT00412984|E2|Reported Event|Apixaban|
645565|NCT00412984|E1|Reported Event|Warfarin|
645566|NCT00412971|B3|Baseline|Total|Total of all reporting groups
645567|NCT00412971|B2|Baseline|White Light|Standard White light cystoscopy
645588|NCT00412958|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
645589|NCT00412958|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
645590|NCT00412958|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
645591|NCT00412958|E4|Reported Event|Placebo|Intravitreal injection of placebo.
645592|NCT00412958|E3|Reported Event|Ocriplasmin 125µg|125µg of ocriplasmin intravitreal injection.
645593|NCT00412958|E2|Reported Event|Ocriplasmin 75µg|75µg of ocriplasmin intravitreal injection.
645594|NCT00412958|E1|Reported Event|Ocriplasmin 25µg|25µg of ocriplasmin intravitreal injection.
645595|NCT00412932|B1|Baseline|Active Treatment Period|All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
645596|NCT00412932|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
645597|NCT00412932|O1|Outcome|Overall Study|
645598|NCT00412932|O1|Outcome|Overall Study|
645599|NCT00412932|O1|Outcome|Overall Study|
645600|NCT00412932|O1|Outcome|Overall Study|
645601|NCT00412932|O1|Outcome|Overall Study|
645602|NCT00412932|O1|Outcome|Overall Study|
645603|NCT00412932|O1|Outcome|Overall Study|
645604|NCT00412893|B3|Baseline|Total|Total of all reporting groups
645605|NCT00412893|B2|Baseline|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645606|NCT00412893|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645607|NCT00412893|P2|Participant Flow|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645608|NCT00412893|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645609|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645610|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645611|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645612|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645613|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645614|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645615|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645616|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645617|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645715|NCT00412737|P1|Participant Flow|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645716|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645618|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645619|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645620|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645621|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645622|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645623|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645624|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645625|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645626|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645627|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645628|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645629|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645630|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645631|NCT00412893|E2|Reported Event|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
645632|NCT00412893|E1|Reported Event|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
645633|NCT00412867|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645634|NCT00412867|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645635|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645636|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645637|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645638|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645639|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645640|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645641|NCT00412867|E2|Reported Event|Alteplase (Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645642|NCT00412867|E1|Reported Event|Alteplase (Non-Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
645643|NCT00412854|B3|Baseline|Total|Total of all reporting groups
645644|NCT00412854|B2|Baseline|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645645|NCT00412854|B1|Baseline|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645646|NCT00412854|P2|Participant Flow|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645647|NCT00412854|P1|Participant Flow|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645648|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645649|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645650|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645651|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645652|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645653|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645654|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645655|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645656|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645657|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645658|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645659|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645660|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645661|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645662|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645663|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645664|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645665|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645666|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645667|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645717|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645772|NCT00412529|E1|Reported Event|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645668|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645669|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645670|NCT00412854|E2|Reported Event|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
645671|NCT00412854|E1|Reported Event|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
645672|NCT00412841|B3|Baseline|Total|Total of all reporting groups
645673|NCT00412841|B2|Baseline|Placebo|
645674|NCT00412841|B1|Baseline|Atorvastatin|Atorvastatin 40mg
645675|NCT00412841|P2|Participant Flow|Placebo|
645676|NCT00412841|P1|Participant Flow|Atorvastatin|40 mg
645677|NCT00412841|O2|Outcome|Placebo|
645678|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
645679|NCT00412841|O2|Outcome|Placebo|
645680|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
645681|NCT00412841|E2|Reported Event|Placebo|Placebo
645682|NCT00412841|E1|Reported Event|Atorvastatin|Atorvastatin 40mg
645683|NCT00412750|B4|Baseline|Total|Total of all reporting groups
645684|NCT00412750|B3|Baseline|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645685|NCT00412750|B2|Baseline|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645686|NCT00412750|B1|Baseline|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645687|NCT00412750|P3|Participant Flow|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645688|NCT00412750|P2|Participant Flow|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645689|NCT00412750|P1|Participant Flow|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645690|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645691|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645692|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645693|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645694|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645695|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645696|NCT00412750|O1|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645697|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645698|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645699|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645700|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645701|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645702|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645703|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645704|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645705|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645706|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645707|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645708|NCT00412750|E3|Reported Event|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
645709|NCT00412750|E2|Reported Event|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
645710|NCT00412750|E1|Reported Event|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
645711|NCT00412737|B3|Baseline|Total|Total of all reporting groups
645712|NCT00412737|B2|Baseline|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645713|NCT00412737|B1|Baseline|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645714|NCT00412737|P2|Participant Flow|Oseltamivir|Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
645718|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645719|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645720|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645721|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645722|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645723|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645724|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645725|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645726|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645727|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645728|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645729|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645730|NCT00412737|E2|Reported Event|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
645731|NCT00412737|E1|Reported Event|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
645732|NCT00412607|B1|Baseline|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645733|NCT00412607|P1|Participant Flow|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645734|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645735|NCT00412607|O3|Outcome|Reported No Recurrence|Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
645736|NCT00412607|O2|Outcome|Reported Recurrence|Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
645737|NCT00412607|O1|Outcome|Total|Total number of subjects who completed 12-month, 2-year, and 3-year follow-up respectively.
645738|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645739|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645740|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645741|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645742|NCT00412607|E1|Reported Event|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
645743|NCT00412542|B3|Baseline|Total|Total of all reporting groups
645744|NCT00412542|B2|Baseline|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
645745|NCT00412542|B1|Baseline|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
645746|NCT00412542|P2|Participant Flow|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
645747|NCT00412542|P1|Participant Flow|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
645748|NCT00412542|O1|Outcome|Participants With Recurrent Malignant Gliomas|The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).
645749|NCT00412542|E1|Reported Event|Patients With Recurrent Malignant Gliomas|The endpoints combined results of all strata
645750|NCT00412529|B3|Baseline|Total|Total of all reporting groups
645751|NCT00412529|B2|Baseline|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645752|NCT00412529|B1|Baseline|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645753|NCT00412529|P2|Participant Flow|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645754|NCT00412529|P1|Participant Flow|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645755|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645756|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645757|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645758|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645759|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645760|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645761|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645762|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645763|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645764|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645765|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645766|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645767|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645768|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645769|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645770|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
645771|NCT00412529|E2|Reported Event|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
645774|NCT00412516|B3|Baseline|Group 3|Measles vaccine followed by SA 14-14-2 one month later
645775|NCT00412516|B2|Baseline|Group 2|Measles and SA 14-14-2 given concurrently
645776|NCT00412516|B1|Baseline|Group 1|SA 14-14-2 followed by measles vaccine one month later
645777|NCT00412516|P3|Participant Flow|Group 3|Measles vaccine followed by SA 14-14-2 one month later
645778|NCT00412516|P2|Participant Flow|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
645779|NCT00412516|P1|Participant Flow|Group 1|SA 14-14-2 followed by measles vaccine one month later
645780|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
645781|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
645782|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
645783|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
645784|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
645785|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
645786|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
645787|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
645788|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
645789|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
645790|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
645791|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
645792|NCT00412516|E3|Reported Event|Group 3|Measles vaccine followed by SA 14-14-2 one month later
645793|NCT00412516|E2|Reported Event|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
645794|NCT00412516|E1|Reported Event|Group 1|SA 14-14-2 followed by measles vaccine one month later
645795|NCT00412464|B1|Baseline|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645796|NCT00412464|P1|Participant Flow|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645797|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645798|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645799|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645800|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645801|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645802|NCT00412464|E1|Reported Event|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
645803|NCT00412451|B5|Baseline|Total|Total of all reporting groups
645804|NCT00412451|B4|Baseline|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
645805|NCT00412451|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
645806|NCT00412451|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
645807|NCT00412451|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
645808|NCT00412451|P4|Participant Flow|Sham Injection|Sham intravitreal injection
645809|NCT00412451|P3|Participant Flow|0criplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
645810|NCT00412451|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
645811|NCT00412451|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injections versus sham injection
645812|NCT00412451|O4|Outcome|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
645813|NCT00412451|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
645814|NCT00412451|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
645815|NCT00412451|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
645816|NCT00412451|E4|Reported Event|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
645817|NCT00412451|E3|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
645818|NCT00412451|E2|Reported Event|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
645819|NCT00412451|E1|Reported Event|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
645820|NCT00412425|B3|Baseline|Total|Total of all reporting groups
645821|NCT00412425|B2|Baseline|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
645822|NCT00412425|B1|Baseline|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
645823|NCT00412425|P2|Participant Flow|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
645824|NCT00412425|P1|Participant Flow|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
645825|NCT00412425|O2|Outcome|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
645826|NCT00412425|O1|Outcome|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
645827|NCT00412425|E2|Reported Event|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
645828|NCT00412425|E1|Reported Event|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
645829|NCT00412373|B3|Baseline|Total|Total of all reporting groups
645938|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645830|NCT00412373|B2|Baseline|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645831|NCT00412373|B1|Baseline|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645832|NCT00412373|P2|Participant Flow|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645833|NCT00412373|P1|Participant Flow|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645834|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645835|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645836|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645837|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645838|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645839|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645840|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645841|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645842|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645843|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645844|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645845|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645846|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645847|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645905|NCT00412217|B1|Baseline|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
645939|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645848|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645849|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645850|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645851|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645852|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645853|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645854|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645855|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645856|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645857|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645858|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645859|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645860|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645861|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645862|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645863|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645864|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645865|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645906|NCT00412217|P2|Participant Flow|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
646042|NCT00411749|P1|Participant Flow|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
645866|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645867|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645868|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645869|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645870|NCT00412373|E2|Reported Event|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
645871|NCT00412373|E1|Reported Event|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
645872|NCT00412360|B3|Baseline|Total|Total of all reporting groups
645873|NCT00412360|B2|Baseline|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645874|NCT00412360|B1|Baseline|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645875|NCT00412360|P2|Participant Flow|Double UCB Transplant|Double Cord Blood Unit Transplantation: Unrelated donor, double cord blood unit
645876|NCT00412360|P1|Participant Flow|Single UCB Transplant|Single Cord Blood Unit Transplantation: Unrelated donor, single cord blood unit
645877|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645878|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645879|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645880|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645881|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645882|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645883|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645884|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645885|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645886|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645887|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645888|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645889|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645890|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645891|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645892|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645893|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645894|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645895|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645896|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645897|NCT00412360|E2|Reported Event|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
645898|NCT00412360|E1|Reported Event|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
645899|NCT00412243|B1|Baseline|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
645900|NCT00412243|P1|Participant Flow|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
645901|NCT00412243|O1|Outcome|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
645902|NCT00412243|E1|Reported Event|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
645903|NCT00412217|B3|Baseline|Total|Total of all reporting groups
645904|NCT00412217|B2|Baseline|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
645937|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
649848|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
645907|NCT00412217|P1|Participant Flow|Erlotinib|Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity.
645908|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
645909|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
645910|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
645911|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
645912|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
645913|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
645914|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
645915|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
645916|NCT00412217|E2|Reported Event|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
645917|NCT00412217|E1|Reported Event|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
645918|NCT00412113|B3|Baseline|Total|Total of all reporting groups
645919|NCT00412113|B2|Baseline|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645920|NCT00412113|B1|Baseline|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645921|NCT00412113|P2|Participant Flow|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645922|NCT00412113|P1|Participant Flow|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645923|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645924|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645925|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645926|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645927|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645928|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645929|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645930|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645931|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645932|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645933|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645934|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645935|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645936|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
649849|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
645940|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645941|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645942|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645943|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645944|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645945|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645946|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645947|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645948|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645949|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645950|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645951|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645952|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645953|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645954|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645955|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645956|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645957|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645958|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645959|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645960|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645961|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645962|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645963|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645964|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645965|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645966|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645967|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645968|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645969|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645970|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645971|NCT00412113|E2|Reported Event|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
645972|NCT00412113|E1|Reported Event|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
645973|NCT00412087|B3|Baseline|Total|Total of all reporting groups
645974|NCT00412087|B2|Baseline|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645975|NCT00412087|B1|Baseline|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645976|NCT00412087|P2|Participant Flow|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645977|NCT00412087|P1|Participant Flow|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645978|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645979|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645980|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645981|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645982|NCT00412087|E2|Reported Event|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645983|NCT00412087|E1|Reported Event|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
645984|NCT00412074|B4|Baseline|Total|Total of all reporting groups
645985|NCT00412074|B3|Baseline|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
645986|NCT00412074|B2|Baseline|2400 Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
645987|NCT00412074|B1|Baseline|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
645988|NCT00412074|P3|Participant Flow|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
645989|NCT00412074|P2|Participant Flow|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
646043|NCT00411749|O4|Outcome|V501-HPV 18|HPV 18 serum antibody titer measured in V501 vaccination group
649850|NCT00402987|O3|Outcome|Placebo|
645990|NCT00412074|P1|Participant Flow|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
645991|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
645992|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
645993|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
645994|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
645995|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
645996|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
645997|NCT00412074|O3|Outcome|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
645998|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
645999|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
646000|NCT00412074|E3|Reported Event|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
646001|NCT00412074|E2|Reported Event|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
646002|NCT00412074|E1|Reported Event|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
646003|NCT00412061|B3|Baseline|Total|Total of all reporting groups
646004|NCT00412061|B2|Baseline|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
646005|NCT00412061|B1|Baseline|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646006|NCT00412061|P2|Participant Flow|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
646007|NCT00412061|P1|Participant Flow|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646008|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
646009|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646010|NCT00412061|O1|Outcome|Everolimus Open Label Arm|Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
646011|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
646012|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646013|NCT00412061|O2|Outcome|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
646014|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646015|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
646016|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646017|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
646018|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646019|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
646020|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646021|NCT00412061|E3|Reported Event|Everolimus Open Label|Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
646022|NCT00412061|E2|Reported Event|Placebo + Octreotide|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
646023|NCT00412061|E1|Reported Event|Everolimus + Octreotide|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
646044|NCT00411749|O3|Outcome|V501-HPV 16|HPV 16 serum antibody titer measured in V501 vaccination group
646045|NCT00411749|O2|Outcome|V501-HPV 11|HPV 11 serum antibody titer measured in V501 vaccination group
646046|NCT00411749|O1|Outcome|V501-HPV 6|HPV 6 serum antibody titer measured in V501 vaccination group
646047|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
646258|NCT00410761|P1|Participant Flow|Vandetanib 300 mg|Vandetanib (300 mg daily)
646024|NCT00411788|B1|Baseline|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646025|NCT00411788|P1|Participant Flow|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646026|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646027|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646028|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646029|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646030|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646031|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646032|NCT00411788|E1|Reported Event|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
646033|NCT00411762|B1|Baseline|PHY906 Administration|PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
646034|NCT00411762|P1|Participant Flow|PHY906 Administration|"PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle~Capecitabine~PHY906"
646035|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
646036|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
646037|NCT00411762|E1|Reported Event|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
646038|NCT00411749|B3|Baseline|Total|Total of all reporting groups
646039|NCT00411749|B2|Baseline|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
646040|NCT00411749|B1|Baseline|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
646041|NCT00411749|P2|Participant Flow|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
646048|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
646049|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
646050|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
646051|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
646052|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
646053|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
646054|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
646055|NCT00411749|E2|Reported Event|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
646056|NCT00411749|E1|Reported Event|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
646057|NCT00411671|B1|Baseline|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
646058|NCT00411671|P1|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
646059|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
646060|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
646061|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
646062|NCT00411671|E1|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
646063|NCT00411645|B3|Baseline|Total|Total of all reporting groups
646064|NCT00411645|B2|Baseline|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646065|NCT00411645|B1|Baseline|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646066|NCT00411645|P2|Participant Flow|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646067|NCT00411645|P1|Participant Flow|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646068|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646069|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646070|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646071|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646072|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646073|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646074|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646075|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646076|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646077|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646078|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646079|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646080|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646081|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646082|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646083|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646084|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646085|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646086|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646087|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646088|NCT00411645|E2|Reported Event|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
646089|NCT00411645|E1|Reported Event|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
646090|NCT00411619|B1|Baseline|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
646091|NCT00411619|P1|Participant Flow|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
646092|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
646093|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
646094|NCT00411619|E1|Reported Event|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
646095|NCT00411554|B3|Baseline|Total|Total of all reporting groups
646096|NCT00411554|B2|Baseline|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
646097|NCT00411554|B1|Baseline|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
646098|NCT00411554|P2|Participant Flow|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
646099|NCT00411554|P1|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
646100|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
646101|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
646102|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
646103|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
646104|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
646105|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
646106|NCT00411554|E2|Reported Event|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
646107|NCT00411554|E1|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
646108|NCT00411463|B3|Baseline|Total|Total of all reporting groups
646109|NCT00411463|B2|Baseline|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
646110|NCT00411463|B1|Baseline|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
646111|NCT00411463|P2|Participant Flow|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
646112|NCT00411463|P1|Participant Flow|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
646113|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
646114|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
646115|NCT00411463|O3|Outcome|Total|Total number of participants
646133|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646134|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646174|NCT00411151|B1|Baseline|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646116|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
646117|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
646118|NCT00411463|O2|Outcome|Medication|Patients taking Quetiapine (Seroquel) during 12 weeks of active treatment.
646119|NCT00411463|O1|Outcome|Psychotherapy|Patients assigned to talk therapy (IPSRT) intervention during 12 weeks of active enrollment in study.
646120|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
646121|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
646122|NCT00411463|E2|Reported Event|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
646123|NCT00411463|E1|Reported Event|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
646124|NCT00411450|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
646125|NCT00411450|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
646126|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
646127|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
646128|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646129|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646130|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646131|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646132|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646250|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
646135|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646136|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646137|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646138|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646139|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646140|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646141|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646142|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646143|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646144|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646145|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646146|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
646147|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646148|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
646149|NCT00411450|E1|Reported Event|Panitumumab + FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
646150|NCT00411411|B3|Baseline|Total|Total of all reporting groups
646151|NCT00411411|B2|Baseline|Januvia|Active treatment
646152|NCT00411411|B1|Baseline|Placebo|Placebo treatment
646153|NCT00411411|P2|Participant Flow|Januvia|Active treatment
646154|NCT00411411|P1|Participant Flow|Placebo|Placebo treatment
646155|NCT00411411|O2|Outcome|Januvia|"Active treatment~Januvia: 200 mg t.i.d"
646156|NCT00411411|O1|Outcome|Placebo|"Placebo treatment, administered as tablets.~Placebo: Placebo"
646157|NCT00411411|O2|Outcome|Januvia|"Active treatment~Januvia: 200 mg t.i.d"
646158|NCT00411411|O1|Outcome|Placebo|Placebo: Placebo
646159|NCT00411411|E2|Reported Event|Januvia|Active treatment. No adverse events recorded
646160|NCT00411411|E1|Reported Event|Placebo|No adverse events recorded
646161|NCT00411398|B1|Baseline|Memantine|Memantine tablets
646162|NCT00411398|P1|Participant Flow|Memantine|Memantine tablets
646163|NCT00411398|O1|Outcome|Memantine|Memantine tablets
646164|NCT00411398|E1|Reported Event|Memantine|Memantine tablets
646165|NCT00411216|B3|Baseline|Total|Total of all reporting groups
646166|NCT00411216|B2|Baseline|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
646167|NCT00411216|B1|Baseline|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
646168|NCT00411216|P2|Participant Flow|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
646169|NCT00411216|P1|Participant Flow|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
646170|NCT00411216|O2|Outcome|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
646171|NCT00411216|O1|Outcome|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
646172|NCT00411216|E2|Reported Event|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
646173|NCT00411216|E1|Reported Event|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
646259|NCT00410761|O2|Outcome|Placebo|Placebo daily
646175|NCT00411151|P1|Participant Flow|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646176|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646177|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646178|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646179|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646180|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646181|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646182|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646183|NCT00411151|E1|Reported Event|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
646184|NCT00411086|B1|Baseline|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
646185|NCT00411086|P1|Participant Flow|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
646186|NCT00411086|O1|Outcome|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
646187|NCT00411086|O1|Outcome|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
646188|NCT00411086|O1|Outcome|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
646189|NCT00411086|E1|Reported Event|Rituximab + GM-CSF|Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
646190|NCT00410904|B3|Baseline|Total|Total of all reporting groups
646191|NCT00410904|B2|Baseline|Arm I Cohort B - Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
646192|NCT00410904|B1|Baseline|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
646193|NCT00410904|P2|Participant Flow|Arm I Cohort B- Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
646194|NCT00410904|P1|Participant Flow|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
646195|NCT00410904|O1|Outcome|Arm I|"Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate~pemetrexed disodium"
646196|NCT00410904|O1|Outcome|Arm I|"Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate~pemetrexed disodium"
646197|NCT00410904|O2|Outcome|Arm I - Cohort B, Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
646198|NCT00410904|O1|Outcome|Arm I - Cohort A, no Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
646251|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
646252|NCT00410813|E2|Reported Event|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
646253|NCT00410813|E1|Reported Event|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
646254|NCT00410761|B3|Baseline|Total|Total of all reporting groups
646199|NCT00410904|E2|Reported Event|Arm I - Cohort B|"This is a one arm study with two cohorts.~Cohort B: Prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
646200|NCT00410904|E1|Reported Event|Arm I - Cohort A|"This is a one arm study with two cohorts.~Cohort A: No prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
646201|NCT00410891|B1|Baseline|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
646202|NCT00410891|P1|Participant Flow|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
646203|NCT00410891|O1|Outcome|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
646204|NCT00410891|E1|Reported Event|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
646205|NCT00410826|B3|Baseline|Total|Total of all reporting groups
646206|NCT00410826|B2|Baseline|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
646207|NCT00410826|B1|Baseline|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
646208|NCT00410826|P2|Participant Flow|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
646209|NCT00410826|P1|Participant Flow|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
646210|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
646211|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
646212|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
646213|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
646214|NCT00410826|E2|Reported Event|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
646215|NCT00410826|E1|Reported Event|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
646216|NCT00410813|B3|Baseline|Total|Total of all reporting groups
646217|NCT00410813|B2|Baseline|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
646218|NCT00410813|B1|Baseline|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
646219|NCT00410813|P2|Participant Flow|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
646220|NCT00410813|P1|Participant Flow|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
646221|NCT00410813|O4|Outcome|Dasatinib - Week 24|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
646222|NCT00410813|O3|Outcome|Dasatinib - Week 16|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
646223|NCT00410813|O2|Outcome|Dasatinib - Week 8|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
646224|NCT00410813|O1|Outcome|Dasatinib - Baseline|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
646225|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
646226|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
646227|NCT00410813|O3|Outcome|TRAP at 8 Weeks|
646228|NCT00410813|O2|Outcome|TRAP at 4 Weeks|
646229|NCT00410813|O1|Outcome|TRAP at Baseline|
646230|NCT00410813|O3|Outcome|OPG at 8 Weeks|
646231|NCT00410813|O2|Outcome|OPG at 4 Weeks|
646232|NCT00410813|O1|Outcome|OPG at Baseline|
646233|NCT00410813|O3|Outcome|OC at 8 Weeks|
646234|NCT00410813|O2|Outcome|OC at 4 Weeks|
646235|NCT00410813|O1|Outcome|OC at Baseline|
646236|NCT00410813|O3|Outcome|Serum Biomarker at 8 Weeks|
646237|NCT00410813|O2|Outcome|Serum Biomarker at 4 Weeks|
646238|NCT00410813|O1|Outcome|Serum Biomarker at Baseline|
646239|NCT00410813|O3|Outcome|BAP at 8 Weeks|
646240|NCT00410813|O2|Outcome|BAP at 4 Weeks|
646241|NCT00410813|O1|Outcome|BAP at Baseline|
646242|NCT00410813|O3|Outcome|NTx at 8 Weeks|
646243|NCT00410813|O2|Outcome|NTx at 4 Weeks|
646244|NCT00410813|O1|Outcome|NTx at Baseline|
646245|NCT00410813|O1|Outcome|Dasatinib|Patients received either Arm 1: Dasatinib, 100 mg, daily or Arm 2: Dasatinib, 70 mg, twice daily.
646246|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
646247|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
646248|NCT00410813|O2|Outcome|Dasatinib, 70 mg, Twice Daily|Dasatinib, 70 mg PO twice daily until progression of disease
646249|NCT00410813|O1|Outcome|Dasatinib, 100 mg, Daily|Dasatinib, 100 mg PO daily until progression of disease
646276|NCT00410761|E1|Reported Event|Vandetanib 300 mg|Vandetanib (300 mg daily)
646277|NCT00410605|B1|Baseline|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646278|NCT00410605|P1|Participant Flow|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646279|NCT00410605|O1|Outcome|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646280|NCT00410605|O1|Outcome|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646281|NCT00410605|O1|Outcome|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646282|NCT00410605|O1|Outcome|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646283|NCT00410605|O1|Outcome|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646284|NCT00410605|O1|Outcome|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646285|NCT00410605|E1|Reported Event|Bevacizumab, Dexamethasone, and Lenalidomide|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~lenalidomide: Given orally~dexamethasone: Given orally"
646286|NCT00410514|B4|Baseline|Total|Total of all reporting groups
646287|NCT00410514|B3|Baseline|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646288|NCT00410514|B2|Baseline|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646289|NCT00410514|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646290|NCT00410514|P3|Participant Flow|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646291|NCT00410514|P2|Participant Flow|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646292|NCT00410514|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646293|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646294|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646295|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646296|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646297|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646298|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646299|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646300|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646301|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646302|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646303|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646304|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646305|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646306|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646307|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646308|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646309|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646310|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646311|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646312|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646313|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646314|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646315|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646316|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646317|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646318|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646319|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646320|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646321|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646322|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646323|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646324|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646325|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646326|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646327|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646328|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646329|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646330|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646331|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646332|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646333|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646334|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646335|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646336|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646337|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646338|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646339|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646340|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646341|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646342|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646343|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646344|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646345|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646346|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646347|NCT00410514|E3|Reported Event|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
646348|NCT00410514|E2|Reported Event|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
646349|NCT00410514|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
646350|NCT00410488|B3|Baseline|Total|Total of all reporting groups
646351|NCT00410488|B2|Baseline|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
646352|NCT00410488|B1|Baseline|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
646370|NCT00410410|B5|Baseline|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646371|NCT00410410|B4|Baseline|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646372|NCT00410410|B3|Baseline|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646353|NCT00410488|P2|Participant Flow|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
646354|NCT00410488|P1|Participant Flow|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
646355|NCT00410488|O2|Outcome|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
646356|NCT00410488|O1|Outcome|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
646357|NCT00410488|E1|Reported Event|Palonosetron|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0) and Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
646358|NCT00410423|B1|Baseline|Bortezomib|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646359|NCT00410423|P4|Participant Flow|Phase 2 - Bortezomib 1.3mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646360|NCT00410423|P3|Participant Flow|Phase 1 - Bortezomib 1.3 mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646361|NCT00410423|P2|Participant Flow|Phase 1 - Bortezomib 1.0 mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646362|NCT00410423|P1|Participant Flow|Phase 1 - Bortezomib 0.7mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646363|NCT00410423|O1|Outcome|Phase 2 - Bortezomib 1.3mg/m^2|Bortezomib 1.3mg/m2: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
646364|NCT00410423|O3|Outcome|Phase 1 - Bortezomib 1.3mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646365|NCT00410423|O2|Outcome|Phase 1 - Bortezomib 1.0 mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646366|NCT00410423|O1|Outcome|Phase 1 - Bortezomib 0.7mg/m^2|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646367|NCT00410423|E1|Reported Event|Bortezomib|"Bortezomib in combination with mitoxantrone, etoposide and cytarabine~Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital."
646368|NCT00410410|B7|Baseline|Total|Total of all reporting groups
646369|NCT00410410|B6|Baseline|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646605|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646373|NCT00410410|B2|Baseline|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646374|NCT00410410|B1|Baseline|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646375|NCT00410410|P9|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646376|NCT00410410|P8|Participant Flow|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646377|NCT00410410|P7|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646378|NCT00410410|P6|Participant Flow|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646379|NCT00410410|P5|Participant Flow|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646380|NCT00410410|P4|Participant Flow|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646381|NCT00410410|P3|Participant Flow|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646382|NCT00410410|P2|Participant Flow|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646383|NCT00410410|P1|Participant Flow|Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646384|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646385|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646386|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646387|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646388|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646389|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646390|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646391|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646392|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646393|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646394|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646395|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646396|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646397|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646398|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646399|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646400|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646401|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646402|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646403|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646404|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646405|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646406|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646407|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646408|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646409|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646410|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646411|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646412|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646413|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646414|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646415|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646416|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646417|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646418|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646419|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646420|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646421|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646422|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646423|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646424|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646425|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646426|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646427|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646428|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646429|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646430|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646431|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646432|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646433|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646434|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646435|NCT00410410|O2|Outcome|IP1C+IP2C: ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646436|NCT00410410|O1|Outcome|IP1C+IP2C: ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646437|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646438|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646439|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646440|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646441|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646442|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646443|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646444|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646445|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646446|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646447|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646448|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
649851|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
646449|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646450|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646451|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646452|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646453|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646454|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646455|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646456|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646457|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646458|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646459|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646460|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646461|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646462|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646463|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646464|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646465|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646466|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646467|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646468|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646469|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646470|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646471|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646472|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646473|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646474|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646475|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646476|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646477|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646478|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646479|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646480|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646481|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646482|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646483|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646484|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646485|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646486|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646487|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646488|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646489|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646490|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646491|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646492|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646493|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646494|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646495|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646496|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646497|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646498|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646499|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646500|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646501|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646502|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646503|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646504|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646505|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646506|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646507|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646508|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646509|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646510|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646511|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646512|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646513|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646514|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646515|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646516|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646517|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646518|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646519|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646520|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646521|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646522|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646523|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646524|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
646525|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646526|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
646527|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646528|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646529|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646530|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646531|NCT00410410|E9|Reported Event|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
646532|NCT00410410|E8|Reported Event|Placebo, IP1C|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
646533|NCT00410410|E7|Reported Event|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
646534|NCT00410410|E6|Reported Event|ABA ~10mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
646535|NCT00410410|E5|Reported Event|ABA ~10mg/kg,IP2C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646536|NCT00410410|E4|Reported Event|ABA ~10 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
646537|NCT00410410|E3|Reported Event|ABA 3 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
646538|NCT00410410|E2|Reported Event|ABA 30/~10mg/kg,IP2C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg.
646539|NCT00410410|E1|Reported Event|ABA 30/~10 mg/kg,IP1C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
646540|NCT00410384|B4|Baseline|Total|Total of all reporting groups
646541|NCT00410384|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646542|NCT00410384|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646543|NCT00410384|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646544|NCT00410384|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646545|NCT00410384|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646546|NCT00410384|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646547|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646548|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646549|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646550|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646551|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646552|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646553|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646554|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646555|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646556|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646557|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646558|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646559|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646560|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646561|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646562|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646563|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646564|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646565|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646566|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646567|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646568|NCT00410384|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646569|NCT00410384|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646570|NCT00410384|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
646571|NCT00410280|B3|Baseline|Total|Total of all reporting groups
646572|NCT00410280|B2|Baseline|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646573|NCT00410280|B1|Baseline|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646574|NCT00410280|P2|Participant Flow|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646575|NCT00410280|P1|Participant Flow|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646576|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646577|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646578|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646579|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646580|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646581|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646582|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646583|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646584|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646585|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646586|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646587|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646588|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646589|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646590|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646591|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646592|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646593|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646594|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646595|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646596|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646597|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646598|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646599|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646600|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646601|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646602|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646603|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646604|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646606|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646607|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646608|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646609|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646610|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646611|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646612|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646613|NCT00410280|E2|Reported Event|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
646614|NCT00410280|E1|Reported Event|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
646615|NCT00410202|B4|Baseline|Total|Total of all reporting groups
646616|NCT00410202|B3|Baseline|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
646617|NCT00410202|B2|Baseline|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646618|NCT00410202|B1|Baseline|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
646619|NCT00410202|P3|Participant Flow|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
646620|NCT00410202|P2|Participant Flow|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646621|NCT00410202|P1|Participant Flow|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
646622|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646623|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646624|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
646625|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646626|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
646627|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
646628|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646629|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
646630|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
646631|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646632|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646633|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646634|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646635|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646636|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646637|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646638|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
646639|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646640|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646641|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
646642|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646643|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646644|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646645|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646646|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646647|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
646648|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646649|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646650|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646651|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646652|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646653|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646654|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646655|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646656|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646657|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646658|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646659|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646660|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646661|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646662|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646663|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646664|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646665|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
646666|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646667|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646668|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646669|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646670|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646671|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646672|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646673|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646674|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646675|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646676|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646677|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646678|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646679|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646680|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646681|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646682|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646683|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646684|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646685|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646686|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646687|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646688|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646689|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646690|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646691|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646692|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646693|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646694|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646695|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646696|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646697|NCT00410202|E3|Reported Event|ETV + ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
646698|NCT00410202|E2|Reported Event|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
646699|NCT00410202|E1|Reported Event|ADV + LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
646700|NCT00410189|B1|Baseline|ZD6474|ZD6474 300 mg by mouth daily.
646701|NCT00410189|P1|Participant Flow|ZD6474|ZD6474 300 mg by mouth daily.
646702|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
646703|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
646704|NCT00410189|E1|Reported Event|ZD6474|ZD6474 300 mg by mouth daily.
646705|NCT00410163|B3|Baseline|Total|Total of all reporting groups
646706|NCT00410163|B2|Baseline|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646707|NCT00410163|B1|Baseline|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646708|NCT00410163|P2|Participant Flow|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
646709|NCT00410163|P1|Participant Flow|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
646710|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646711|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646712|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646713|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646714|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646715|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646716|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646717|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646718|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646719|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646720|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646721|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646722|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646723|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646724|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646725|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646726|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646727|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646728|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646729|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646730|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646731|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646732|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646733|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646734|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646735|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646736|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646737|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646738|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646739|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646740|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646741|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646742|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646743|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646744|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646745|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646746|NCT00410163|E4|Reported Event|Ofatumumab 1000 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
646747|NCT00410163|E3|Reported Event|Ofatumumab 500 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
646748|NCT00410163|E2|Reported Event|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646749|NCT00410163|E1|Reported Event|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
646750|NCT00410150|B3|Baseline|Total|Total of all reporting groups
646751|NCT00410150|B2|Baseline|Control Group|Subjects randomized to the control arm of the study
646752|NCT00410150|B1|Baseline|Heliox Group|Patients randomized to the Heliox arm of the study
646753|NCT00410150|P2|Participant Flow|Control Group|Subjects randomized to the control arm of the study
646754|NCT00410150|P1|Participant Flow|Heliox Group|Patients randomized to the Heliox arm of the study
646755|NCT00410150|O2|Outcome|Control Group|Subjects randomized to the control arm of the study
646756|NCT00410150|O1|Outcome|Heliox Group|Patients randomized to the Heliox arm of the study
646757|NCT00410150|E2|Reported Event|Control Group|Subjects randomized to the control arm of the study
646758|NCT00410150|E1|Reported Event|Heliox Group|Patients randomized to the Heliox arm of the study
646759|NCT00410124|B3|Baseline|Total|Total of all reporting groups
646760|NCT00410124|B2|Baseline|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646761|NCT00410124|B1|Baseline|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646762|NCT00410124|P2|Participant Flow|Placebo + BSC / RAD001|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646763|NCT00410124|P1|Participant Flow|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646764|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
646765|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
646766|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
646767|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
646768|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
646769|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
649852|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
646770|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
646771|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
646772|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
646773|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
646774|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646775|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646776|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646777|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646778|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646779|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646780|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646781|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646782|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646783|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646784|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646823|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646824|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646825|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646826|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646785|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646786|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646787|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646788|NCT00410124|E3|Reported Event|Randomized to Placebo + BSC (Double Blind Only)|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care.
646789|NCT00410124|E2|Reported Event|Randomized to Placebo + BSC (Open Label)|With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646790|NCT00410124|E1|Reported Event|Randomized to RAD001+ BSC ( Blinded + Open Label)|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
646791|NCT00410072|B3|Baseline|Total|Total of all reporting groups
646792|NCT00410072|B2|Baseline|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646793|NCT00410072|B1|Baseline|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646794|NCT00410072|P2|Participant Flow|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646795|NCT00410072|P1|Participant Flow|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646796|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646797|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646798|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646799|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646800|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646801|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646802|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646803|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646804|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646805|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646806|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646807|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646808|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646809|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646810|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646811|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646812|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646813|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646814|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646815|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646816|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646817|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646818|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646819|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646820|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646821|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646822|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
646827|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
646828|NCT00410072|E2|Reported Event|ETV/TDF 0.5 mg +TDF 300 mg|ETV 0.5 mg plus TDF 300 mg combination therapy given once daily (QD) for 100 weeks
646829|NCT00410072|E1|Reported Event|ETV 0.5 mg|ETV 0.5 mg monotherapy given QD for 100 weeks
646830|NCT00410059|B1|Baseline|Erlotinib|150 mg orally day for 28 days.
646831|NCT00410059|P1|Participant Flow|Erlotinib|150 mg orally day for 28 days.
646832|NCT00410059|O1|Outcome|Erlotinib|150 mg orally day for 28 days.
646833|NCT00410059|E1|Reported Event|Erlotinib|150 mg orally day for 28 days.
646834|NCT00410046|B1|Baseline|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646835|NCT00410046|P1|Participant Flow|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646836|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646837|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646838|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646839|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646840|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646841|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646842|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646843|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646844|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646845|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646846|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646847|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646848|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646849|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646850|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646851|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646852|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646853|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646854|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646855|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646856|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646857|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646858|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646859|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646959|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646860|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646861|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646862|NCT00410046|E1|Reported Event|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
646863|NCT00409838|B3|Baseline|Total|Total of all reporting groups
646864|NCT00409838|B2|Baseline|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646865|NCT00409838|B1|Baseline|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646866|NCT00409838|P2|Participant Flow|Placebo|Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).
646867|NCT00409838|P1|Participant Flow|Abatacept, 10 mg/kg|"Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).~Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg."
646868|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646869|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646870|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646871|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646872|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646873|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646874|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646875|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646876|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646877|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646878|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646879|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646880|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646920|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646881|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646882|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646883|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
646884|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
646885|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Abatacept administered IV in a body-weight tiered dose approximating 10 mg/kg. Study medication was administered on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
646886|NCT00409838|O1|Outcome|All Treated|Abatacept was administered intravenously monthly at a fixed dose of approximately 10 mg/kg in the LTE period on a background of methotrexate
646887|NCT00409838|O1|Outcome|All Treated|Abatacept, administered intravenously IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months in the LTE period on a background of methotrexate
646888|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646889|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646890|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646891|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646892|NCT00409838|O1|Outcome|Abatacept + Background Methotrexate|Dosage: 500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646893|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
646894|NCT00409838|O2|Outcome|Abatacept 750 mg|
646895|NCT00409838|O1|Outcome|Abatacept 500 mg|
646896|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
646897|NCT00409838|O2|Outcome|Abatacept 750 mg|
646898|NCT00409838|O1|Outcome|Abatacept 500 mg|
646899|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
646900|NCT00409838|O2|Outcome|Abatacept 750 mg|
646901|NCT00409838|O1|Outcome|Abatacept 500 mg|
646902|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
646903|NCT00409838|O2|Outcome|Abatacept 750 mg|
646904|NCT00409838|O1|Outcome|Abatacept 500 mg|
646905|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
646906|NCT00409838|O2|Outcome|Abatacept 750 mg|
646907|NCT00409838|O1|Outcome|Abatacept 500 mg|
646908|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
646909|NCT00409838|O2|Outcome|Abatacept 750 mg|
646910|NCT00409838|O1|Outcome|Abatacept 500 mg|
646911|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646912|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646913|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646914|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646915|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646916|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646917|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646918|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646919|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646921|NCT00409838|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
646922|NCT00409838|O1|Outcome|Abatacept|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
646923|NCT00409838|O2|Outcome|Placebo|Participants received placebo IV on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
646924|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
646925|NCT00409838|E2|Reported Event|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646926|NCT00409838|E1|Reported Event|Abatacept 10 mg/kg|500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
646927|NCT00409825|B1|Baseline|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
646928|NCT00409825|P1|Participant Flow|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
646929|NCT00409825|O1|Outcome|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.
646930|NCT00409825|E1|Reported Event|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 4, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 3: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
646931|NCT00409786|B1|Baseline|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
646932|NCT00409786|P1|Participant Flow|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
646933|NCT00409786|O1|Outcome|Group 1|All participants
646934|NCT00409786|E1|Reported Event|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
646935|NCT00409773|B6|Baseline|Total|Total of all reporting groups
646936|NCT00409773|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646937|NCT00409773|B4|Baseline|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646938|NCT00409773|B3|Baseline|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646939|NCT00409773|B2|Baseline|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646940|NCT00409773|B1|Baseline|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646941|NCT00409773|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646942|NCT00409773|P4|Participant Flow|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646943|NCT00409773|P3|Participant Flow|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646944|NCT00409773|P2|Participant Flow|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646945|NCT00409773|P1|Participant Flow|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646946|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646947|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646948|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646949|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646950|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646951|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646952|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646953|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646954|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646955|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646956|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646957|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646958|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646960|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646961|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646962|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646963|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646964|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646965|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646966|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646967|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646968|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646969|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646970|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646971|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646972|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646973|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646974|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646975|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646976|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646977|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646978|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646979|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646980|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646981|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646982|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646983|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646984|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646985|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646986|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646987|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646988|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646989|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646990|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646991|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646992|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646993|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646994|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
646995|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
646996|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
646997|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
646998|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
646999|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
647000|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
647001|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
647002|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
647003|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
647004|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
647005|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
647006|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
647007|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
647008|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
647009|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
647010|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
647011|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
647012|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
647013|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
647014|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
647015|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
647016|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
647017|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
647018|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
647019|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
647020|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
647021|NCT00409773|E5|Reported Event|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
647022|NCT00409773|E4|Reported Event|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
647023|NCT00409773|E3|Reported Event|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
647024|NCT00409773|E2|Reported Event|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
647025|NCT00409773|E1|Reported Event|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
647026|NCT00409747|B1|Baseline|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
647027|NCT00409747|P1|Participant Flow|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
647028|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
647029|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
647030|NCT00409747|E1|Reported Event|Overall Study/Minocycline|
647031|NCT00409708|B3|Baseline|Total|Total of all reporting groups
647032|NCT00409708|B2|Baseline|Behavior Therapy|0 mg/day Ritalin LA
647033|NCT00409708|B1|Baseline|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647034|NCT00409708|P2|Participant Flow|Behavior Therapy|0 mg/day Ritalin LA
647035|NCT00409708|P1|Participant Flow|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647036|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
647037|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647038|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
647039|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647040|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
647041|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647042|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
647043|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647044|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
647045|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647046|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
647047|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647048|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
647049|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
647050|NCT00409708|E2|Reported Event|Behavior|Behavior
647051|NCT00409708|E1|Reported Event|Ritalin+Behavior|Ritalin+Behavior
647052|NCT00409682|B4|Baseline|Total|Total of all reporting groups
647053|NCT00409682|B3|Baseline|Low-Dose Adalimumab: 20 mg or 10 mg (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647054|NCT00409682|B2|Baseline|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647055|NCT00409682|B1|Baseline|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
647056|NCT00409682|P3|Participant Flow|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647057|NCT00409682|P2|Participant Flow|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647058|NCT00409682|P1|Participant Flow|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing < 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2.
647059|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647104|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
647237|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647060|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647061|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647062|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647063|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647064|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647065|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647066|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647067|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647068|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647069|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
647105|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647106|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
647238|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647070|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
647071|NCT00409682|E3|Reported Event|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|
647072|NCT00409682|E2|Reported Event|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|
647073|NCT00409682|E1|Reported Event|Open-label Adalimumab (Week 0 to Week 4)|
647074|NCT00409617|B1|Baseline|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647075|NCT00409617|P1|Participant Flow|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647076|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647077|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647078|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647079|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647080|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647081|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647082|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647131|NCT00409539|P3|Participant Flow|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647239|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
649853|NCT00402987|O3|Outcome|Placebo|
647083|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647084|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647085|NCT00409617|E1|Reported Event|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
647086|NCT00409578|B5|Baseline|Total|Total of all reporting groups
647087|NCT00409578|B4|Baseline|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647088|NCT00409578|B3|Baseline|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
647089|NCT00409578|B2|Baseline|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647090|NCT00409578|B1|Baseline|Placebo|Placebo tablets and capsules
647091|NCT00409578|P4|Participant Flow|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647092|NCT00409578|P3|Participant Flow|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
647093|NCT00409578|P2|Participant Flow|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647094|NCT00409578|P1|Participant Flow|Placebo|Placebo tablets and capsules
647095|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647096|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
647097|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647098|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
647099|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647100|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
647101|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647102|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
647103|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647240|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
649854|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
647107|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647108|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
647109|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647110|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
647111|NCT00409578|E4|Reported Event|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647112|NCT00409578|E3|Reported Event|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
647113|NCT00409578|E2|Reported Event|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
647114|NCT00409578|E1|Reported Event|Placebo|Placebo tablets and capsules
647115|NCT00409565|B1|Baseline|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647116|NCT00409565|P1|Participant Flow|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647117|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647118|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647119|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647120|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647121|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647122|NCT00409565|E1|Reported Event|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
647123|NCT00409539|B6|Baseline|Total|Total of all reporting groups
647124|NCT00409539|B5|Baseline|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647125|NCT00409539|B4|Baseline|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647126|NCT00409539|B3|Baseline|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647127|NCT00409539|B2|Baseline|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647128|NCT00409539|B1|Baseline|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
647129|NCT00409539|P5|Participant Flow|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647130|NCT00409539|P4|Participant Flow|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647180|NCT00409331|P1|Participant Flow|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
647132|NCT00409539|P2|Participant Flow|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647133|NCT00409539|P1|Participant Flow|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
647134|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647135|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647136|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647137|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647138|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
647139|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647140|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647141|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647142|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647143|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
647144|NCT00409539|E5|Reported Event|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647145|NCT00409539|E4|Reported Event|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647146|NCT00409539|E3|Reported Event|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647147|NCT00409539|E2|Reported Event|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
647148|NCT00409539|E1|Reported Event|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
647149|NCT00409409|B3|Baseline|Total|Total of all reporting groups
647150|NCT00409409|B2|Baseline|Placebo|Placebo tablet
647151|NCT00409409|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
647152|NCT00409409|P2|Participant Flow|Placebo|Placebo tablet
647153|NCT00409409|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
647154|NCT00409409|O2|Outcome|Placebo|Placebo tablet
647155|NCT00409409|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
647156|NCT00409409|E2|Reported Event|Placebo|Placebo tablet
647157|NCT00409409|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
647158|NCT00409344|B3|Baseline|Total|Total of all reporting groups
647159|NCT00409344|B2|Baseline|Dexmedetomidine|This group will receive dexmedetomidine
647160|NCT00409344|B1|Baseline|Saline|This group will recive saline
647161|NCT00409344|P2|Participant Flow|Dexmedetomidine|This group will receive dexmedetomidine
647162|NCT00409344|P1|Participant Flow|Saline|This group will recive saline
647163|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
647164|NCT00409344|O1|Outcome|Saline|This group will recive saline
647165|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
647166|NCT00409344|O1|Outcome|Saline|This group will recive saline
647167|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
647168|NCT00409344|O1|Outcome|Saline|This group will recive saline
647169|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
647170|NCT00409344|O1|Outcome|Saline|This group will recive saline
647171|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
647172|NCT00409344|O1|Outcome|Saline|This group will recive saline
647173|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
647174|NCT00409344|O1|Outcome|Saline|This group will recive saline
647175|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
647176|NCT00409344|O1|Outcome|Saline|This group will recive saline
647177|NCT00409344|E2|Reported Event|Dexmedetomidine|This group will receive dexmedetomidine
647178|NCT00409344|E1|Reported Event|Saline|This group will recive saline
647179|NCT00409331|B1|Baseline|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
647235|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647181|NCT00409331|O1|Outcome|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
647182|NCT00409331|E1|Reported Event|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
647183|NCT00409292|B1|Baseline|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
647184|NCT00409292|P1|Participant Flow|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment."
647185|NCT00409292|O1|Outcome|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment.~RAD001: Taken orally daily for as long as the participant continues to receive a benefit."
647186|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
647187|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
647188|NCT00409292|O1|Outcome|RAD001|RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
647189|NCT00409292|E1|Reported Event|RAD001|
647190|NCT00409240|B3|Baseline|Total|Total of all reporting groups
647191|NCT00409240|B2|Baseline|Usual Care|Patient continued on usual care
647192|NCT00409240|B1|Baseline|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
647193|NCT00409240|P2|Participant Flow|Usual Care|Patient continued on usual care
647194|NCT00409240|P1|Participant Flow|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
647195|NCT00409240|O2|Outcome|Usual Care|Patient continued on usual care
647196|NCT00409240|O1|Outcome|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
647197|NCT00409240|E2|Reported Event|Usual Care|Patient continued on usual care
647198|NCT00409240|E1|Reported Event|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
647199|NCT00409188|B3|Baseline|Total|Total of all reporting groups
647200|NCT00409188|B2|Baseline|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647201|NCT00409188|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647202|NCT00409188|P2|Participant Flow|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647203|NCT00409188|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647204|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647205|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647206|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647236|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
649855|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
647207|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647208|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647209|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647210|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647211|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647212|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647213|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647214|NCT00409188|E2|Reported Event|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
647215|NCT00409188|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
647216|NCT00409175|B3|Baseline|Total|Total of all reporting groups
647217|NCT00409175|B2|Baseline|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647218|NCT00409175|B1|Baseline|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647219|NCT00409175|P2|Participant Flow|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647220|NCT00409175|P1|Participant Flow|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647221|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647222|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647223|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647224|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647225|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647226|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647227|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647228|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647229|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647230|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647231|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647232|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647233|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647234|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
649856|NCT00402987|O3|Outcome|Placebo|
647241|NCT00409175|E2|Reported Event|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
647242|NCT00409175|E1|Reported Event|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
647243|NCT00409006|B3|Baseline|Total|Total of all reporting groups
647244|NCT00409006|B2|Baseline|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647245|NCT00409006|B1|Baseline|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647246|NCT00409006|P2|Participant Flow|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647247|NCT00409006|P1|Participant Flow|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647248|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647249|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647250|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647251|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647252|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647253|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647254|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647255|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647256|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647257|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647258|NCT00409006|E2|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
647259|NCT00409006|E1|Reported Event|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
647260|NCT00408993|B3|Baseline|Total|Total of all reporting groups
647261|NCT00408993|B2|Baseline|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647262|NCT00408993|B1|Baseline|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647263|NCT00408993|P2|Participant Flow|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647264|NCT00408993|P1|Participant Flow|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647265|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647266|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647267|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647268|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647269|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647270|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647271|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647272|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647273|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647274|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647275|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647276|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647277|NCT00408993|O4|Outcome|Placebo - Evening Dosing|Placebo QD, PO for 12 weeks
647278|NCT00408993|O3|Outcome|Placebo - Morning Dosing|Placebo QD, PO for 12 weeks
647279|NCT00408993|O2|Outcome|Duloxetine - Evening Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647280|NCT00408993|O1|Outcome|Duloxetine - Morning Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647281|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647282|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647283|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647284|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647285|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647286|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647287|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647288|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647289|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647290|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647291|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
647292|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
647293|NCT00408993|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
647294|NCT00408993|E1|Reported Event|Placebo|Placebo
647295|NCT00408928|B1|Baseline|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
647296|NCT00408928|P1|Participant Flow|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
647297|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
647298|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
647299|NCT00408928|E1|Reported Event|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
647300|NCT00408902|B1|Baseline|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
647301|NCT00408902|P1|Participant Flow|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
647302|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
647303|NCT00408902|O1|Outcome|TandutinibTreatment|"Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally, 500 mg bid daily~laboratory biomarker analysis: Correlative studies"
647304|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
647305|NCT00408902|E1|Reported Event|TandutinibTreatment|"Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~laboratory biomarker analysis: Correlative studies"
647306|NCT00408876|B5|Baseline|Total|Total of all reporting groups
647307|NCT00408876|B4|Baseline|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
648406|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
647308|NCT00408876|B3|Baseline|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647309|NCT00408876|B2|Baseline|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647310|NCT00408876|B1|Baseline|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647311|NCT00408876|P4|Participant Flow|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647312|NCT00408876|P3|Participant Flow|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647313|NCT00408876|P2|Participant Flow|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647314|NCT00408876|P1|Participant Flow|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647315|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647316|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647317|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647318|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647319|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647320|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647321|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647322|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647323|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647324|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647325|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647326|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647327|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647328|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647329|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647330|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647331|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647332|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647333|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647334|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647335|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647336|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647337|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647338|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647339|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647340|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647341|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647342|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647343|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647344|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647345|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647346|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647347|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647348|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647349|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647350|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647351|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647352|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647353|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647354|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647355|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647356|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647357|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647358|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647359|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647360|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647361|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647362|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647363|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647364|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647365|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647366|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647367|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647368|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647369|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647370|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647371|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647372|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647373|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647374|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647375|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647376|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647377|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647378|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647379|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647380|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647381|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647382|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647383|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647384|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647385|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647386|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647387|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647388|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647389|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647390|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647391|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647392|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647393|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647394|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647395|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647396|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647397|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647398|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647399|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647400|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647401|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647402|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647403|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
649857|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
647404|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647405|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647406|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647407|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647408|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647409|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647410|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647411|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647412|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647413|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647414|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647415|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647416|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647417|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647418|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647419|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647420|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647421|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647422|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647423|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647424|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647425|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647426|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647427|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647428|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647429|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647430|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647431|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647432|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647433|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647434|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647435|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647436|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647437|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647438|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647439|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647440|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647441|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647442|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647443|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647444|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647445|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647446|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647447|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647448|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647449|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647450|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647451|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
649858|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
647452|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647453|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647454|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647455|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647456|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647457|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647458|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647459|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647460|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647461|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647462|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647463|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647464|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647465|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647466|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647467|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647468|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647469|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647470|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647471|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647472|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647473|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647474|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647475|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647476|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647477|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647478|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647479|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647480|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647481|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647482|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647483|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647484|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647485|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647486|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647487|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647488|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647489|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647490|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647491|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647492|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647493|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647494|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647495|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647496|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647497|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647498|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647499|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
649859|NCT00402987|O3|Outcome|Placebo|
647500|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647501|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647502|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647503|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647504|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647505|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647506|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647507|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647508|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647509|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647510|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647511|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647512|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647513|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647514|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647515|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647516|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647517|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647518|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647519|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647520|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647521|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647522|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647523|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647524|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647525|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647526|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647527|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647528|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647529|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647530|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647531|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647532|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647533|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647534|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647535|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647536|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647537|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647538|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647539|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647540|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647541|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647542|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647543|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647544|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647545|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647546|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647547|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
649860|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
647548|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647549|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647550|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647551|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647552|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647553|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647554|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647555|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647556|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647557|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647558|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647559|NCT00408876|E4|Reported Event|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
647560|NCT00408876|E3|Reported Event|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
647561|NCT00408876|E2|Reported Event|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
647562|NCT00408876|E1|Reported Event|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
647563|NCT00408694|B1|Baseline|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647564|NCT00408694|P1|Participant Flow|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647565|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647566|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647567|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647568|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647586|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
648407|NCT00406393|E2|Reported Event|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
647569|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647570|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647571|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647572|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647573|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
647574|NCT00408694|E1|Reported Event|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients."
647575|NCT00408681|B1|Baseline|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647576|NCT00408681|P1|Participant Flow|Treated Patients|Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647577|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647578|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647579|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647580|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647581|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647582|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647583|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647584|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647585|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
648408|NCT00406393|E1|Reported Event|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
647587|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647588|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647589|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647590|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647591|NCT00408681|E1|Reported Event|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
647592|NCT00408629|B3|Baseline|Total|Total of all reporting groups
647593|NCT00408629|B2|Baseline|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647594|NCT00408629|B1|Baseline|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647595|NCT00408629|P2|Participant Flow|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647596|NCT00408629|P1|Participant Flow|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647597|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647598|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647599|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647600|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647601|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647602|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647603|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647604|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647605|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647606|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647607|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647608|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647609|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647610|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647611|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647612|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647613|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647614|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647615|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647616|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647617|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647618|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647619|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647620|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647621|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647622|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647623|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
648409|NCT00406367|B3|Baseline|Total|Total of all reporting groups
647624|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647625|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647626|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647627|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647628|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647629|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
647630|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647631|NCT00408629|E3|Reported Event|Any Adalimumab|During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 [160/80/40 mg]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods.
647632|NCT00408629|E2|Reported Event|Placebo Group - Double-Blind Period|The placebo treatment group received placebo throughout the Double-Blind period.
647633|NCT00408629|E1|Reported Event|Adalimumab Group - Double-Blind Period|During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
647634|NCT00408603|B4|Baseline|Total|Total of all reporting groups
647635|NCT00408603|B3|Baseline|75 mg/m2|75 mg/m2 every 28 days
647636|NCT00408603|B2|Baseline|60 mg/m2|60 mg/m2 every 28 days
647637|NCT00408603|B1|Baseline|48 mg/m2|48 mg/m2 every 21 days
647638|NCT00408603|P3|Participant Flow|Stage 75 mg/m2|Following safety of 60 mg/m2 group, next Stage is 75 mg/m2 at 28 day periods up to 6 cycles.
647639|NCT00408603|P2|Participant Flow|Stage 60 mg/m2|Following safety of 48 mg/m2 group, next Stagel is 60mg/m2 at 28 day periods up to 6 cycles.
647640|NCT00408603|P1|Participant Flow|Stage 48 mg/m2|"All Stage 1 patients will receive voreloxin injection~Voreloxin Injection: All Stage 1 patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles."
647641|NCT00408603|O4|Outcome|Total|Overall
647642|NCT00408603|O3|Outcome|75 mg/m2|75 mg/m2 every 28 days
647643|NCT00408603|O2|Outcome|60 mg/m2|60 mg/m2 every 28 days
647644|NCT00408603|O1|Outcome|48 mg/m2|48 mg/m2 every 21 days
647645|NCT00408603|O4|Outcome|Total|Overall
647646|NCT00408603|O3|Outcome|75 mg/m2|75 mg/m2 every 28 days
647647|NCT00408603|O2|Outcome|60 mg/m2|60 mg/m2 every 28 days
647648|NCT00408603|O1|Outcome|48 mg/m2|48 mg/m2 every 21 days
647649|NCT00408603|E4|Reported Event|Total|Overall
647650|NCT00408603|E3|Reported Event|75 mg/m2|75 mg/m2 every 28 days
647651|NCT00408603|E2|Reported Event|60 mg/m2|60 mg/m2 every 28 days
647652|NCT00408603|E1|Reported Event|48 mg/m2|48 mg/m2 every 21 days
647653|NCT00408590|B3|Baseline|Total|Total of all reporting groups
647654|NCT00408590|B2|Baseline|Cohort 2|Includes all dose levels of Cohort 2
647655|NCT00408590|B1|Baseline|Cohort 1|Includes all dose levels of Cohort 1
647656|NCT00408590|P9|Participant Flow|Cohort 2, Dose Level 2|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
647657|NCT00408590|P8|Participant Flow|Cohort 2, Dose Level 1|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
647658|NCT00408590|P7|Participant Flow|Cohort 1, Dose Level 7|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647659|NCT00408590|P6|Participant Flow|Cohort 1, Dose Level 6|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647660|NCT00408590|P5|Participant Flow|Cohort 1, Dose Level 5|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647661|NCT00408590|P4|Participant Flow|Cohort 1, Dose Level 4|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647662|NCT00408590|P3|Participant Flow|Cohort 1, Dose Level 3|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647663|NCT00408590|P2|Participant Flow|Cohort 1, Dose Level 2|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 2, these patients received a 10^4 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647664|NCT00408590|P1|Participant Flow|Cohort 1, Dose Level 1|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 1, these patients received a 10^3 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647665|NCT00408590|O2|Outcome|Cohort 2|Includes all dose levels of Cohort 2
647666|NCT00408590|O1|Outcome|Cohort 1|Includes all dose levels of Cohort 1
647667|NCT00408590|O9|Outcome|Cohort 2, Dose Level 2|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
647668|NCT00408590|O8|Outcome|Cohort 2, Dose Level 1|Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
647669|NCT00408590|O7|Outcome|Cohort 1, Dose Level 7|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647670|NCT00408590|O6|Outcome|Cohort 1, Dose Level 6|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647671|NCT00408590|O5|Outcome|Cohort 1, Dose Level 5|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647672|NCT00408590|O4|Outcome|Cohort 1, Dose Level 4|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647673|NCT00408590|O3|Outcome|Cohort 1, Dose Level 3|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647674|NCT00408590|O2|Outcome|Cohort 1, Dose Level 2|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 2, these patients received a 10^4 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647675|NCT00408590|O1|Outcome|Cohort 1, Dose Level 1|Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 1, these patients received a 10^3 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
647676|NCT00408590|O2|Outcome|Cohort 2|Includes all dose levels of Cohort 2
647677|NCT00408590|O1|Outcome|Cohort 1|Includes all dose levels of Cohort 1
647678|NCT00408590|O2|Outcome|Cohort 2|Includes all dose levels of Cohort 2
647679|NCT00408590|O1|Outcome|Cohort 1|Includes all dose levels of Cohort 1
647680|NCT00408590|E2|Reported Event|Cohort 2|Includes all dose levels of Cohort 2
647681|NCT00408590|E1|Reported Event|Cohort 1|Includes all dose levels of Cohort 1
647682|NCT00408499|B1|Baseline|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
647683|NCT00408499|P5|Participant Flow|Phase II- Dose Expansion|Phase II dose expansion at determined MTD
647684|NCT00408499|P4|Participant Flow|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
647685|NCT00408499|P3|Participant Flow|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
647686|NCT00408499|P2|Participant Flow|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
647687|NCT00408499|P1|Participant Flow|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
647688|NCT00408499|O1|Outcome|Phase II Expansion|44 Patients at dose level 4 phase II expansion: 150 mg Erlotinib, 250 mg/m2 Cetuximab
647689|NCT00408499|O1|Outcome|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
647690|NCT00408499|O4|Outcome|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
647691|NCT00408499|O3|Outcome|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
647692|NCT00408499|O2|Outcome|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
647693|NCT00408499|O1|Outcome|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
647717|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647718|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
648558|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
647694|NCT00408499|E1|Reported Event|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
647695|NCT00408460|B1|Baseline|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
647696|NCT00408460|P1|Participant Flow|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
647697|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
647698|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
647699|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
647700|NCT00408460|E1|Reported Event|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
647701|NCT00408421|B3|Baseline|Total|Total of all reporting groups
647702|NCT00408421|B2|Baseline|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647703|NCT00408421|B1|Baseline|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647704|NCT00408421|P3|Participant Flow|Duloxetine 120 mg|Beginning at Week 7, patients receiving duloxetine 60 mg daily (QD) were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD
647705|NCT00408421|P2|Participant Flow|Duloxetine 60 mg|Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.
647706|NCT00408421|P1|Participant Flow|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647707|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647708|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647709|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647710|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647711|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647712|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647713|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647714|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647715|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647716|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
648039|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
647719|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647720|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647721|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647722|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647723|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647724|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647725|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647726|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647727|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647728|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647729|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
647730|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
647731|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647732|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647733|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647734|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647735|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647736|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647737|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647738|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647739|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647740|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647741|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647742|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647743|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647744|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647745|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647746|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647797|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647747|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647748|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647749|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647750|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647751|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647752|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647753|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647754|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647755|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647756|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647757|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647758|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647759|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
647760|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
647761|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647762|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647763|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647764|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647765|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647766|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647767|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647768|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647769|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647770|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647771|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647772|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647773|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647774|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647864|NCT00408317|E1|Reported Event|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion,for 6 to 7 days in either first intervention period or second intervention period.
647775|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
647776|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
647777|NCT00408421|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
647778|NCT00408421|E1|Reported Event|Placebo|Placebo
647779|NCT00408408|B7|Baseline|Total|Total of all reporting groups
647780|NCT00408408|B6|Baseline|Docetaxel + Gem + Bev Then AC + Bev|Docetaxel + Gem + Bev then AC + Bev
647781|NCT00408408|B5|Baseline|Docetaxel + Gem Then AC|Docetaxel + Gem then AC
647782|NCT00408408|B4|Baseline|Docetaxel + Cape + Bev Then AC + Bev|Docetaxel + Cape + Bev then AC + Bev
647783|NCT00408408|B3|Baseline|Docetaxel + Capecitabine Then AC|Docetaxel + Capecitabine then AC
647784|NCT00408408|B2|Baseline|Docetaxel + Bev Then AC + Bev|Docetaxel + Bev then AC + Bev
647785|NCT00408408|B1|Baseline|Docetaxel Then AC|Docetaxel then AC
647786|NCT00408408|P6|Participant Flow|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647787|NCT00408408|P5|Participant Flow|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647788|NCT00408408|P4|Participant Flow|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647789|NCT00408408|P3|Participant Flow|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647790|NCT00408408|P2|Participant Flow|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647791|NCT00408408|P1|Participant Flow|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647792|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647793|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647794|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647795|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647796|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647865|NCT00408200|B3|Baseline|Total|Total of all reporting groups
648559|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
647798|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647799|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647800|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647801|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647802|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647803|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647804|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647805|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647806|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647807|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647808|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647809|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647810|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647811|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647919|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647812|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647813|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647814|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647815|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647816|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647817|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647818|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647819|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647820|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647821|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647822|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647823|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647824|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647825|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647920|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647826|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647827|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647828|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647829|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647830|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647831|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647832|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647833|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647834|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647835|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647836|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647837|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647838|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647839|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647881|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647840|NCT00408408|O6|Outcome|Arm 3B: Docetaxel + Gem + Bev Then AC + Bev|"Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647841|NCT00408408|O5|Outcome|Arm 3A: Docetaxel + Gem Then AC|"Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV~gemcitabine hydrochloride: 1000 mg/m2 IV"
647842|NCT00408408|O4|Outcome|Arm 2B: Docetaxel + Cape + Bev Then AC + Bev|"Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.~bevacizumab: 15 mg/kg IV~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647843|NCT00408408|O3|Outcome|Arm 2A: Docetaxel + Capecitabine Then AC|"Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.~capecitabine: 825 mg/m2 orally~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647844|NCT00408408|O2|Outcome|Arm 1B Docetaxel + Bev Then AC + Bev|"Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.~bevacizumab: 15 mg/kg IV~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647845|NCT00408408|O1|Outcome|Arm 1A: Docetaxel Then AC|"Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).~cyclophosphamide: 600 mg/m2 IV~docetaxel: 100 mg/m2 IV~doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV"
647846|NCT00408408|E6|Reported Event|Docetaxel + Gem + Bev Then AC + Bev|Docetaxel + Gem + Bev then AC + Bev
647847|NCT00408408|E5|Reported Event|Docetaxel + Gem Then AC|Docetaxel + Gem then AC
647848|NCT00408408|E4|Reported Event|Docetaxel + Cape + Bev Then AC + Bev|Docetaxel + Cape + Bev then AC + Bev
647849|NCT00408408|E3|Reported Event|Docetaxel + Capecitabine Then AC|Docetaxel + Capecitabine then AC
647850|NCT00408408|E2|Reported Event|Docetaxel + Bev Then AC + Bev|Docetaxel + Bev then AC + Bev
647851|NCT00408408|E1|Reported Event|Docetaxel Then AC|Docetaxel then AC
647852|NCT00408317|B1|Baseline|Entire Study Population|Includes all participants who received Ultrase® MT20 first and placebo first.
647853|NCT00408317|P2|Participant Flow|Placebo First, Then Ultrase®MT20|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the first intervention period followed by Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
647854|NCT00408317|P1|Participant Flow|Ultrase® MT20 First, Then Placebo|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the first intervention period followed by placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
647855|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
647856|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
647857|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
647858|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
647859|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
647860|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
647861|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
647862|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
647863|NCT00408317|E2|Reported Event|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
648003|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
647866|NCT00408200|B2|Baseline|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
647867|NCT00408200|B1|Baseline|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
647868|NCT00408200|P2|Participant Flow|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
647869|NCT00408200|P1|Participant Flow|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
647870|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
647871|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
647872|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
647873|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
647874|NCT00408200|E2|Reported Event|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
647875|NCT00408200|E1|Reported Event|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
647876|NCT00408070|B1|Baseline|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647877|NCT00408070|P1|Participant Flow|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647878|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647879|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647880|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647882|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647883|NCT00408070|E1|Reported Event|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
647884|NCT00407966|B1|Baseline|Arm A|Flavopiridol, ara-C, mitoxantrone
647885|NCT00407966|P1|Participant Flow|Arm A|Flavopiridol, ara-C, mitoxantrone
647886|NCT00407966|O1|Outcome|Arm A|Flavopiridol, ara-C, mitoxantrone
647887|NCT00407966|E1|Reported Event|Arm A|Flavopiridol, ara-C, mitoxantrone
647888|NCT00407888|B1|Baseline|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647889|NCT00407888|P1|Participant Flow|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647890|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647891|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647892|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647893|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647918|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
648040|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
647894|NCT00407888|O1|Outcome|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647895|NCT00407888|E1|Reported Event|Arm I|"Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1, oral cyclophosphamide once daily on days 1-7, and filgrastim subcutaneously on days 2-7. Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 week later, patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with HER-2/neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~filgrastim: Given SC~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~trastuzumab: Given IV~laboratory biomarker analysis: Correlative studies~quality-of-life assessment: Ancillary studies"
647896|NCT00407797|B1|Baseline|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
647897|NCT00407797|P1|Participant Flow|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
647898|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647899|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647900|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647901|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647902|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647903|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647904|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647905|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647906|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647907|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647908|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647909|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647910|NCT00407797|E1|Reported Event|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
647911|NCT00407758|B1|Baseline|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647912|NCT00407758|P1|Participant Flow|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647913|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647914|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647915|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647916|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647917|NCT00407758|O1|Outcome|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
648447|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
647921|NCT00407758|E1|Reported Event|Enzastaurin|Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
647922|NCT00407745|B3|Baseline|Total|Total of all reporting groups
647923|NCT00407745|B2|Baseline|Placebo|Placebo matching study treatment.
647924|NCT00407745|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647925|NCT00407745|P2|Participant Flow|Placebo|Placebo matching study treatment.
647926|NCT00407745|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647927|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647928|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647929|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647930|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647931|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647932|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647933|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647934|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647935|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647936|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647937|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647938|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647939|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647940|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647941|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
648004|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
648041|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
647942|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647943|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647944|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647945|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647946|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647947|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647948|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647949|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647950|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647951|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647952|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647953|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647954|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647955|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647956|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647957|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647958|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647959|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647960|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647961|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
648005|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
647962|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647963|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647964|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647965|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647966|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647967|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647968|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647969|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647970|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647971|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647972|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647973|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647974|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647975|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647976|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647977|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647978|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647979|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647980|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647981|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
648006|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
648550|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
647982|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647983|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647984|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647985|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647986|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647987|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647988|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647989|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647990|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647991|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647992|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647993|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
647994|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647995|NCT00407745|E2|Reported Event|Placebo|Placebo matching study treatment.
647996|NCT00407745|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
647997|NCT00407654|B1|Baseline|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
647998|NCT00407654|P1|Participant Flow|VEGF Trap IV Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
647999|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
648000|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
648001|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
648002|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
648042|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648007|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
648008|NCT00407654|E1|Reported Event|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
648009|NCT00407563|B1|Baseline|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648010|NCT00407563|P1|Participant Flow|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648011|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648012|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648013|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648014|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648015|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648016|NCT00407563|E1|Reported Event|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
648017|NCT00407550|B3|Baseline|Total|Total of all reporting groups
648018|NCT00407550|B2|Baseline|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
648019|NCT00407550|B1|Baseline|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
648020|NCT00407550|P2|Participant Flow|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
648021|NCT00407550|P1|Participant Flow|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
648022|NCT00407550|O2|Outcome|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
648023|NCT00407550|O1|Outcome|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
648024|NCT00407550|E2|Reported Event|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
648025|NCT00407550|E1|Reported Event|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
648026|NCT00407537|B3|Baseline|Total|Total of all reporting groups
648027|NCT00407537|B2|Baseline|Usual Care as Assigned|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648028|NCT00407537|B1|Baseline|Caduet as Assigned|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648029|NCT00407537|P2|Participant Flow|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648030|NCT00407537|P1|Participant Flow|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648031|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648032|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648033|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648034|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648035|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648036|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648037|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648038|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648228|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
648043|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648044|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648045|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648046|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648047|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648048|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648049|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648050|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648051|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648052|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648053|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648054|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648055|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648056|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648057|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648058|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648059|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648060|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648061|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648062|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648063|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648064|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648065|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648066|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648067|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648068|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648069|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648070|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648071|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648072|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648229|NCT00406783|E2|Reported Event|Placebo Tablet|placebo tablet, once daily for 15 days
648551|NCT00406133|O1|Outcome|CGM Group|Participants randomized to CGM Use
648073|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648074|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648075|NCT00407537|E2|Reported Event|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
648076|NCT00407537|E1|Reported Event|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
648077|NCT00407511|B1|Baseline|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648078|NCT00407511|P1|Participant Flow|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648079|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648080|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648081|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648082|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648083|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648084|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648085|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648086|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648087|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648088|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648230|NCT00406783|E1|Reported Event|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
648089|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648090|NCT00407511|E1|Reported Event|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
648091|NCT00407485|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
648092|NCT00407485|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
648093|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
648094|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
648095|NCT00407485|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
648096|NCT00407381|B4|Baseline|Total|Total of all reporting groups
648097|NCT00407381|B3|Baseline|Laser With RBZ|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648098|NCT00407381|B2|Baseline|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648099|NCT00407381|B1|Baseline|Ranibizumab Only|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
648100|NCT00407381|P3|Participant Flow|Laser With Ranibizumab (RBZ)|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648101|NCT00407381|P2|Participant Flow|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648102|NCT00407381|P1|Participant Flow|Ranibizumab Only|"Ranibizumab (RBZ) intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria."
648103|NCT00407381|O3|Outcome|Laser With RBZ|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648104|NCT00407381|O2|Outcome|Laser Alone|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648105|NCT00407381|O1|Outcome|RBZ Alone|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
648106|NCT00407381|E3|Reported Event|Laser With Ranibizumab|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648107|NCT00407381|E2|Reported Event|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
648108|NCT00407381|E1|Reported Event|Ranibizumab Only|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
648109|NCT00407355|B3|Baseline|Total|Total of all reporting groups
648110|NCT00407355|B2|Baseline|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648111|NCT00407355|B1|Baseline|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648112|NCT00407355|P2|Participant Flow|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648113|NCT00407355|P1|Participant Flow|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648114|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648115|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648116|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648231|NCT00406718|B4|Baseline|Total|Total of all reporting groups
648117|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648118|NCT00407355|E2|Reported Event|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648119|NCT00407355|E1|Reported Event|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
648120|NCT00407030|B4|Baseline|Total|Total of all reporting groups
648121|NCT00407030|B3|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648122|NCT00407030|B2|Baseline|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648123|NCT00407030|B1|Baseline|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648124|NCT00407030|P3|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648125|NCT00407030|P2|Participant Flow|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648126|NCT00407030|P1|Participant Flow|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648127|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648128|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648129|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648130|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648131|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648132|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648133|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648134|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648135|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648136|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648137|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648138|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648139|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648140|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648141|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648142|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648143|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648144|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648145|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648146|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648147|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648148|NCT00407030|E3|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
648149|NCT00407030|E2|Reported Event|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
648150|NCT00407030|E1|Reported Event|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
648151|NCT00406848|B3|Baseline|Total|Total of all reporting groups
648152|NCT00406848|B2|Baseline|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648153|NCT00406848|B1|Baseline|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648154|NCT00406848|P2|Participant Flow|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648155|NCT00406848|P1|Participant Flow|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648156|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648157|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648158|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648294|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648159|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648160|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648161|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648162|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648163|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648164|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648165|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648166|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648167|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648168|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648169|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648170|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648171|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648172|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648173|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648552|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
648174|NCT00406848|O3|Outcome|Placebo Rescue|Participants who were randomized to placebo at baseline and for whom rescue treatment was required during the continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally until completing or discontinuing from the study.
648175|NCT00406848|O2|Outcome|Placebo Non-rescue|Participants who were randomized to placebo at baseline and for whom treatment rescue was not required during continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they continued to receive placebo until completing or discontinuing from the study.
648176|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648177|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648178|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648179|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648180|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648181|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648182|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648183|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648184|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648185|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648186|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648187|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648188|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
649861|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
648189|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648190|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648191|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648192|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648193|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648194|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648195|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648196|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648197|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648198|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648199|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648200|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648201|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648202|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648203|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
649862|NCT00402987|O4|Outcome|Placebo|
648204|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648205|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648206|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648207|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648208|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648209|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648210|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648211|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
648212|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648213|NCT00406848|E3|Reported Event|Rescued Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally for the remainder of the study. Results are for the randomized placebo patients who were rescued to duloxetine and reported events while they were on duloxetine.
648214|NCT00406848|E2|Reported Event|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity. Results are for the randomized placebo patients who reported events while they were on placebo.
648215|NCT00406848|E1|Reported Event|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
648216|NCT00406783|B3|Baseline|Total|Total of all reporting groups
648217|NCT00406783|B2|Baseline|Placebo Tablet|placebo tablet, once daily for 15 days
648218|NCT00406783|B1|Baseline|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
648219|NCT00406783|P2|Participant Flow|Placebo Tablet|placebo tablet, once daily for 15 days
648220|NCT00406783|P1|Participant Flow|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
648221|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
648222|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
648223|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
648224|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
648225|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
648226|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
648227|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
648232|NCT00406718|B3|Baseline|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
648233|NCT00406718|B2|Baseline|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
648234|NCT00406718|B1|Baseline|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
648235|NCT00406718|P3|Participant Flow|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
648236|NCT00406718|P2|Participant Flow|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
648237|NCT00406718|P1|Participant Flow|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
648238|NCT00406718|O3|Outcome|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
648239|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
648240|NCT00406718|O1|Outcome|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
648241|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
648242|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
648243|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
648244|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
648245|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
648246|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
648247|NCT00406718|E3|Reported Event|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
648248|NCT00406718|E2|Reported Event|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
648295|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648553|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
648249|NCT00406718|E1|Reported Event|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
648250|NCT00406692|B1|Baseline|Zonisamide|400 mg daily
648251|NCT00406692|P1|Participant Flow|Zonisamide|400 mg daily
648252|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
648253|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
648254|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
648255|NCT00406692|E1|Reported Event|Zonisamide|400 mg daily
648256|NCT00406653|B5|Baseline|Total|Total of all reporting groups
648257|NCT00406653|B4|Baseline|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648258|NCT00406653|B3|Baseline|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
648259|NCT00406653|B2|Baseline|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
648260|NCT00406653|B1|Baseline|ABA 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648261|NCT00406653|P7|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648262|NCT00406653|P6|Participant Flow|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648263|NCT00406653|P5|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648264|NCT00406653|P4|Participant Flow|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648265|NCT00406653|P3|Participant Flow|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
648266|NCT00406653|P2|Participant Flow|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
648267|NCT00406653|P1|Participant Flow|Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648268|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648269|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648270|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648271|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648272|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648273|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648274|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648275|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648276|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648277|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648278|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648279|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648280|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648281|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648282|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648283|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648284|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648285|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648286|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648287|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648288|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648289|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648290|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648291|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648292|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648293|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648296|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648297|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648298|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648299|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648300|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648301|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648302|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648303|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648304|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648305|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648306|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648307|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648308|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648309|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648310|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648311|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648312|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648313|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648314|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648315|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648316|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648317|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648318|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648319|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648320|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648321|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648322|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648323|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648324|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648325|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648326|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648327|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
649863|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
648328|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648329|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648330|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648331|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648332|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648333|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648334|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648335|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
648336|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
648337|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648338|NCT00406653|E7|Reported Event|Placebo (MP)|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
648339|NCT00406653|E6|Reported Event|Placebo (IP)|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
648340|NCT00406653|E5|Reported Event|ABA ~10mg/kg (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
648341|NCT00406653|E4|Reported Event|ABA ~10mg/kg (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
648342|NCT00406653|E3|Reported Event|ABA ~10mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
648343|NCT00406653|E2|Reported Event|ABA 3mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
648344|NCT00406653|E1|Reported Event|ABA 30/~10mg/kg (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
648345|NCT00406640|B3|Baseline|Total|Total of all reporting groups
648346|NCT00406640|B2|Baseline|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648347|NCT00406640|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648348|NCT00406640|P2|Participant Flow|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648349|NCT00406640|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648399|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648400|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648350|NCT00406640|O2|Outcome|Escitalopram (ESC)|Taper Phase Day 239 or at discontinuation: If patients taking escitalopram 20 mg/day, then decrease to 10 mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10 mg/day decreased to matching escitalopram placebo/day for 7 days.
648351|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648352|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
648353|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
648354|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
648355|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
648356|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
648357|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
648358|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
648359|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
648360|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
648361|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
648362|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648363|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648364|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648401|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648402|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648403|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648404|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648365|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648366|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648367|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648368|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648369|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648370|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648371|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648372|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648405|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
649864|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
648373|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648374|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648375|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648376|NCT00406640|E2|Reported Event|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
648377|NCT00406640|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
648378|NCT00406393|B3|Baseline|Total|Total of all reporting groups
648379|NCT00406393|B2|Baseline|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648380|NCT00406393|B1|Baseline|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648381|NCT00406393|P2|Participant Flow|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648382|NCT00406393|P1|Participant Flow|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648383|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648384|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648385|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648386|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648387|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648388|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648389|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648390|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648391|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648392|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648393|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648394|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648395|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648396|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
648397|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
648398|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
649865|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
648410|NCT00406367|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
648411|NCT00406367|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
648412|NCT00406367|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
648413|NCT00406367|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
648414|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
648415|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
648416|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
648417|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
648418|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
648419|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
648420|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
648421|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
648422|NCT00406367|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
648423|NCT00406367|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
648424|NCT00406354|B4|Baseline|Total|Total of all reporting groups
648425|NCT00406354|B3|Baseline|Placebo|matching placebo daily dose taken orally
648426|NCT00406354|B2|Baseline|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648427|NCT00406354|B1|Baseline|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648428|NCT00406354|P3|Participant Flow|Placebo|matching placebo daily dose taken orally
648429|NCT00406354|P2|Participant Flow|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648430|NCT00406354|P1|Participant Flow|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648431|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648432|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648433|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648434|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648435|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648436|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648437|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648438|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648439|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648440|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648441|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648442|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648443|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648444|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648445|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648446|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648554|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648448|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648449|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648450|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648451|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648452|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648453|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648454|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648455|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648456|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648457|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648458|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648459|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648460|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648461|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648462|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648463|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648464|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648465|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648466|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648467|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648468|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648469|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648470|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648471|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648472|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648473|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648474|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648475|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648476|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648477|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648478|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648479|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648480|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648481|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648482|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648483|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648484|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648485|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648486|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648487|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648488|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648489|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648490|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648491|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648555|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648492|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648493|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648494|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
648495|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648496|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648497|NCT00406354|E3|Reported Event|Placebo|matching placebo daily dose taken orally
648498|NCT00406354|E2|Reported Event|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
648499|NCT00406354|E1|Reported Event|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
648500|NCT00406315|B1|Baseline|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648501|NCT00406315|P1|Participant Flow|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648502|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648503|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648504|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648505|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648506|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648507|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648508|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648509|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648510|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648511|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648556|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648557|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
649866|NCT00402987|O3|Outcome|Placebo|
648512|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648513|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648514|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648515|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648516|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648517|NCT00406315|E1|Reported Event|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
648518|NCT00406276|B1|Baseline|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
648519|NCT00406276|P1|Participant Flow|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
648520|NCT00406276|O1|Outcome|Docetaxel/RAD001|
648521|NCT00406276|O1|Outcome|Docetaxel/RAD001|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
648522|NCT00406276|E1|Reported Event|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
648523|NCT00406133|B5|Baseline|Total|Total of all reporting groups
648524|NCT00406133|B4|Baseline|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
648525|NCT00406133|B3|Baseline|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
648526|NCT00406133|B2|Baseline|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
648527|NCT00406133|B1|Baseline|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
648528|NCT00406133|P4|Participant Flow|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
648529|NCT00406133|P3|Participant Flow|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
648530|NCT00406133|P2|Participant Flow|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
648531|NCT00406133|P1|Participant Flow|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
648532|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
648533|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
648534|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
648535|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
648536|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648537|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648538|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648539|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648540|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648541|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648542|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648543|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648544|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648545|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648546|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HBA1c >=7.0% who were randomized to standard care
648547|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648548|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648549|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648560|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648561|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648562|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648563|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648564|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648565|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648566|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648567|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648568|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648569|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648570|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648571|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648572|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648573|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648574|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648575|NCT00406133|O1|Outcome|Primary Cohort RT-CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648576|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648577|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648578|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648579|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648580|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648581|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648582|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648583|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648584|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
648585|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
648586|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
648587|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
648588|NCT00406133|E4|Reported Event|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
648589|NCT00406133|E3|Reported Event|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
648590|NCT00406133|E2|Reported Event|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
648591|NCT00406133|E1|Reported Event|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
648592|NCT00406107|B3|Baseline|Total|Total of all reporting groups
648593|NCT00406107|B2|Baseline|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
648594|NCT00406107|B1|Baseline|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
648595|NCT00406107|P2|Participant Flow|Pegaptanib Sodium 1 mg (Macugen)|
648596|NCT00406107|P1|Participant Flow|Pegaptanib Sodium 0.3mg (Macugen)|
648597|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
648598|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
648599|NCT00406107|O2|Outcome|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
648600|NCT00406107|O1|Outcome|Pegaptanib Sodium 0.3mg (Macugen)|Patients experiencing an ocular adverse event, in this case a retinal detachment
648601|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
648602|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
648603|NCT00406107|E2|Reported Event|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
648604|NCT00406107|E1|Reported Event|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
648605|NCT00406029|B6|Baseline|Total|Total of all reporting groups
648606|NCT00406029|B5|Baseline|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648607|NCT00406029|B4|Baseline|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648608|NCT00406029|B3|Baseline|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648609|NCT00406029|B2|Baseline|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648610|NCT00406029|B1|Baseline|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648611|NCT00406029|P5|Participant Flow|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648612|NCT00406029|P4|Participant Flow|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648613|NCT00406029|P3|Participant Flow|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648614|NCT00406029|P2|Participant Flow|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648615|NCT00406029|P1|Participant Flow|Preladenant 1 mg BID|Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period.
648616|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648617|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648618|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648619|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648620|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648621|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648622|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648623|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648624|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648625|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648626|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648627|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648628|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648629|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648630|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648631|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648632|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648633|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648634|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648635|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648636|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648637|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648638|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648639|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648640|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648641|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648642|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648643|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648644|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648645|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648646|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648647|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648648|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648649|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648650|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648651|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648652|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648653|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648654|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648655|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648656|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648657|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
649867|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
648658|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648659|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648660|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648661|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648662|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648663|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648664|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648665|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648666|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648667|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648668|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648669|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648670|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648671|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648672|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648673|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648674|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648675|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648676|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648677|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648678|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648679|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648680|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648681|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648682|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648683|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648684|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648685|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648686|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648687|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648688|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648689|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648690|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648691|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648692|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648693|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648694|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648695|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648696|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648697|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648698|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648699|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648700|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648701|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648702|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648703|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648704|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648705|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648706|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648707|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648708|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648709|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648710|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648711|NCT00406029|E5|Reported Event|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
648712|NCT00406029|E4|Reported Event|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
648713|NCT00406029|E3|Reported Event|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
648714|NCT00406029|E2|Reported Event|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
648715|NCT00406029|E1|Reported Event|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
648716|NCT00405964|B3|Baseline|Total|Total of all reporting groups
648717|NCT00405964|B2|Baseline|Placebo Tablet|Matching placebo, orally daily.
648718|NCT00405964|B1|Baseline|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
648719|NCT00405964|P2|Participant Flow|Placebo Tablet|Matching placebo, orally daily.
648720|NCT00405964|P1|Participant Flow|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
648721|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
648722|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
648723|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
648724|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
648725|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
648726|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
648727|NCT00405964|E2|Reported Event|Placebo Tablet|Matching placebo, orally daily.
648728|NCT00405964|E1|Reported Event|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
648729|NCT00405938|B3|Baseline|Total|Total of all reporting groups
648730|NCT00405938|B2|Baseline|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
648731|NCT00405938|B1|Baseline|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
648732|NCT00405938|P2|Participant Flow|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
648733|NCT00405938|P1|Participant Flow|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
648734|NCT00405938|O2|Outcome|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
648735|NCT00405938|O1|Outcome|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
648736|NCT00405938|E2|Reported Event|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
648737|NCT00405938|E1|Reported Event|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
648738|NCT00405912|B4|Baseline|Total|Total of all reporting groups
648739|NCT00405912|B3|Baseline|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
648740|NCT00405912|B2|Baseline|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
648741|NCT00405912|B1|Baseline|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
648742|NCT00405912|P3|Participant Flow|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
648743|NCT00405912|P2|Participant Flow|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
648744|NCT00405912|P1|Participant Flow|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
648745|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
648746|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
648747|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
648748|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
648749|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
648750|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
648751|NCT00405912|E3|Reported Event|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
648752|NCT00405912|E2|Reported Event|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
648753|NCT00405912|E1|Reported Event|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
648754|NCT00405821|B3|Baseline|Total|Total of all reporting groups
648755|NCT00405821|B2|Baseline|Placebo Tablet Twice Daily|
648756|NCT00405821|B1|Baseline|Acyclovir 400mg Tablet Twice Daily|
648757|NCT00405821|P2|Participant Flow|Placebo Tablet Twice Daily|
648758|NCT00405821|P1|Participant Flow|Acyclovir 400mg Tablet Twice Daily|
648759|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
648760|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
648761|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
648762|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
648763|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
648764|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
648765|NCT00405821|E2|Reported Event|Placebo Tablet Twice Daily|
648766|NCT00405821|E1|Reported Event|Acyclovir 400mg Tablet Twice Daily|
648767|NCT00405756|B4|Baseline|Total|Total of all reporting groups
648768|NCT00405756|B3|Baseline|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648769|NCT00405756|B2|Baseline|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648770|NCT00405756|B1|Baseline|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648771|NCT00405756|P3|Participant Flow|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648772|NCT00405756|P2|Participant Flow|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648773|NCT00405756|P1|Participant Flow|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648774|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648775|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648861|NCT00405704|B2|Baseline|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
649732|NCT00402987|P4|Participant Flow|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
648776|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648777|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648778|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648779|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648780|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648781|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648782|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648783|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648784|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648785|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648786|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648787|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648788|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648789|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648790|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648791|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648792|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648793|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648794|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648795|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648796|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648929|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
648797|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648798|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648799|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648800|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648801|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648802|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648803|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648804|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648805|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648806|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648807|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648808|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648809|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648810|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648811|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648812|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648813|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648814|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648815|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648816|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648817|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648930|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
648818|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648819|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648820|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648821|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648822|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648823|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648824|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648825|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648826|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648827|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648828|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648829|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648830|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648831|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648832|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648833|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648834|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648835|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648836|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648837|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648838|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648931|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
648839|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648840|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648841|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648842|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648843|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648844|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648845|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648846|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648847|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648848|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648849|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648850|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648851|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648852|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648853|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648854|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648855|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648856|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648857|NCT00405756|E3|Reported Event|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648858|NCT00405756|E2|Reported Event|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648859|NCT00405756|E1|Reported Event|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
648860|NCT00405704|B3|Baseline|Total|Total of all reporting groups
649868|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
648862|NCT00405704|B1|Baseline|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648863|NCT00405704|P2|Participant Flow|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648864|NCT00405704|P1|Participant Flow|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648865|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648866|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648867|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648868|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648869|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648870|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648871|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648872|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648873|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648874|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648875|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648876|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648877|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648878|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648879|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648880|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648881|NCT00405704|E2|Reported Event|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
648882|NCT00405704|E1|Reported Event|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
648883|NCT00405652|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
648884|NCT00405652|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
648885|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
648886|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
648887|NCT00405652|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
648888|NCT00405639|B3|Baseline|Total|Total of all reporting groups
648889|NCT00405639|B2|Baseline|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648890|NCT00405639|B1|Baseline|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648891|NCT00405639|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
649733|NCT00402987|P3|Participant Flow|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
648892|NCT00405639|P1|Participant Flow|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648893|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648894|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648895|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648896|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648897|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648898|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648899|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648900|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648901|NCT00405639|E2|Reported Event|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648902|NCT00405639|E1|Reported Event|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
648903|NCT00405587|B5|Baseline|Total|Total of all reporting groups
648904|NCT00405587|B4|Baseline|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
648963|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
648905|NCT00405587|B3|Baseline|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
648906|NCT00405587|B2|Baseline|Dose Escalation: MBP Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules/tablets in MBP formulation at a starting dose of 160 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 MBP formulation for 4 weeks. Dose escalation was continued up to unacceptable toxicity or disease progression occurred.
648907|NCT00405587|B1|Baseline|Dose Escalation: Original Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules in original (crystalline) formulation at a starting dose of 200 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 original formulation for 4 weeks. Dose escalation was continued up to 1600 mg BID dose level.
648908|NCT00405587|P4|Participant Flow|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
648909|NCT00405587|P3|Participant Flow|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg BID until disease progression, death, or withdrawal from the study.
648910|NCT00405587|P2|Participant Flow|Dose Escalation: MBP Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules/tablets in MBP formulation at a starting dose of 160 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 MBP formulation for 4 weeks. Dose escalation was continued up to unacceptable toxicity or disease progression occurred.
648911|NCT00405587|P1|Participant Flow|Dose Escalation: Original Formulation|Cohorts of 3 to 6 participants received RO5185426 capsules in original (crystalline) formulation at a starting dose of 200 mg BID for 4 weeks. After Day 15 pharmacokinetic assessment and adequate safety and tolerability was shown, next cohort of 3 to 6 participants received 50 % to 100% increased dose of RO5185426 original formulation for 4 weeks. Dose escalation was continued up to 1600 mg BID dose level.
648912|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation and Extension: BRAFV600E- Pos|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules in MBP formulation at a dose of 960 mg BID , or 960 mg BID dose escalation
648913|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 80 mg Capsule|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID dose escalation/paired biopsy cohort, or 720 mg BID dose escalation/paired biopsy cohort, or 1120 mg BID dose escalation for 4 weeks.
648914|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation and Extension: BRAFV600E- Pos|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules in MBP formulation at a dose of 960 mg BID , or 960 mg BID dose escalation
648915|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 80 mg Capsule|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID dose escalation/paired biopsy cohort, or 720 mg BID dose escalation/paired biopsy cohort, or 1120 mg BID dose escalation for 4 weeks.
648916|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648917|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648918|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648919|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648920|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648921|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648922|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation –1120 mg|Participants received RO5185426 hard gelatin capsules at a dose of 1120 mg BID for 4 weeks.
648923|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation –720 mg|Participants received RO5185426 hard gelatin capsules at a dose of 720 mg BID for 4 weeks.
648924|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation –360 mg|Participants received RO5185426 hard gelatin capsules at a dose of 360 mg BID for 4 weeks.
648925|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation –320 mg|Participants received RO5185426 hard gelatin capsules at a dose of 320 mg BID for 4 weeks.
648926|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation –240 mg|Participants received RO5185426 hard gelatin capsules at a dose of 240 mg BID for 4 weeks.
648927|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation –160 mg|Participants received RO5185426 hard gelatin capsules at a dose of 160 mg BID for 4 weeks.
648928|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
648932|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648933|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648934|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648935|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648936|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648937|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648938|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648939|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648940|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648941|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648942|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648943|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648944|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648945|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648946|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
648947|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
648948|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
648949|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
648950|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
648951|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
648952|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
648953|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
648954|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
648955|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
648956|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
648957|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
648958|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
648959|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
648960|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
648961|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
648962|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
649869|NCT00402987|O4|Outcome|Placebo|
648964|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
648965|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation – 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
648966|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation – 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
648967|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation – 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
648968|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation – 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
648969|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation – 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
648970|NCT00405587|O2|Outcome|Extension: BRAFV600E- Positive CRC|Participants with CRC that carried the V600E mutation of BRAF received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648971|NCT00405587|O1|Outcome|Extension: BRAFV600E- Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185426 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
648972|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
648973|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation - 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
648974|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
648975|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
648976|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
648977|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
648978|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
648979|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation - 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
648980|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
648981|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
648982|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
648983|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
648984|NCT00405587|O6|Outcome|Dose Escalation: MBP Formulation – 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
648985|NCT00405587|O5|Outcome|Dose Escalation: MBP Formulation - 960 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 960 mg BID for 4 weeks.
648986|NCT00405587|O4|Outcome|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
648987|NCT00405587|O3|Outcome|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
648988|NCT00405587|O2|Outcome|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
648989|NCT00405587|O1|Outcome|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
648990|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
648991|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
648992|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
648993|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
648994|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
648995|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
648996|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
648997|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
648998|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
648999|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
649000|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
649001|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
649870|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
649002|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
649003|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
649004|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
649005|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
649006|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
649007|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
649008|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
649009|NCT00405587|O1|Outcome|Dose Escalation Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
649010|NCT00405587|O4|Outcome|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
649011|NCT00405587|O3|Outcome|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
649012|NCT00405587|O2|Outcome|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
649013|NCT00405587|O1|Outcome|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
649014|NCT00405587|E12|Reported Event|Extension: BRAFV600E-Positive CRC|Participants with CRC that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185246 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
649015|NCT00405587|E11|Reported Event|Extension: BRAFV600E-Positive Melanoma|Participants with melanoma tumors that carried the V600E mutation of the v-raf murine sarcoma viral oncogene homologue B1 (BRAF) received RO5185246 capsules/tablets in MBP formulation at a dose of 960 mg bid until disease progression, death, or withdrawal from the study.
649016|NCT00405587|E10|Reported Event|Dose Escalation: Original Formulation - 1600 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 1600 mg BID for 4 weeks.
649017|NCT00405587|E9|Reported Event|Dose Escalation: Original Formulation - 800 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 800 mg BID for 4 weeks.
649018|NCT00405587|E8|Reported Event|Dose Escalation: Original Formulation - 400 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 400 mg BID for 4 weeks.
649019|NCT00405587|E7|Reported Event|Dose Escalation: Original Formulation - 200 mg|Participants received RO5185426 capsules in original (crystalline) formulation at a dose of 200 mg BID for 4 weeks.
649020|NCT00405587|E6|Reported Event|Dose Escalation: MBP Formulation - 1120 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 1120 mg BID for 4 weeks.
649021|NCT00405587|E5|Reported Event|Dose Escalation: MBP Formulation - 720 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 720 mg BID for 4 weeks.
649022|NCT00405587|E4|Reported Event|Dose Escalation: MBP Formulation - 360 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 360 mg BID for 4 weeks.
649023|NCT00405587|E3|Reported Event|Dose Escalation: MBP Formulation - 320 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 320 mg BID for 4 weeks.
649024|NCT00405587|E2|Reported Event|Dose Escalation: MBP Formulation - 240 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 240 mg BID for 4 weeks.
649025|NCT00405587|E1|Reported Event|Dose Escalation: MBP Formulation - 160 mg|Participants received RO5185426 capsules in MBP formulation at a dose of 160 mg BID for 4 weeks.
649026|NCT00405548|B3|Baseline|Total|Total of all reporting groups
649027|NCT00405548|B2|Baseline|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
649028|NCT00405548|B1|Baseline|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
649029|NCT00405548|P2|Participant Flow|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
649030|NCT00405548|P1|Participant Flow|BNP (Nesiritide)|Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
649031|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
649032|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
649033|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
649034|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
649035|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
649036|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
649037|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
649038|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
649039|NCT00405548|E2|Reported Event|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
649040|NCT00405548|E1|Reported Event|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
649041|NCT00405509|B3|Baseline|Total|Total of all reporting groups
649154|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649042|NCT00405509|B2|Baseline|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
649043|NCT00405509|B1|Baseline|Confirmed Respiratory Infection|participants who had the type of viral infection confirmed by assay
649044|NCT00405509|P2|Participant Flow|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
649045|NCT00405509|P1|Participant Flow|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
649046|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
649047|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
649048|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
649049|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
649050|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
649051|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
649052|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
649053|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
649054|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
649055|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
649056|NCT00405509|E2|Reported Event|Unconfirmed Respiratory Infection|
649057|NCT00405509|E1|Reported Event|Confirmed Respiratory Virus|
649058|NCT00405288|B3|Baseline|Total|Total of all reporting groups
649059|NCT00405288|B2|Baseline|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649060|NCT00405288|B1|Baseline|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649061|NCT00405288|P2|Participant Flow|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649062|NCT00405288|P1|Participant Flow|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649063|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649064|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649065|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649066|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649067|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649068|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649069|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649070|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649071|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649072|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649073|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649074|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649075|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649076|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649077|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649155|NCT00404924|E2|Reported Event|Placebo|Placebo
649078|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649079|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649080|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649081|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649082|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649083|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649084|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649085|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649086|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649087|NCT00405288|E2|Reported Event|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
649088|NCT00405288|E1|Reported Event|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
649089|NCT00405275|B3|Baseline|Total|Total of all reporting groups
649090|NCT00405275|B2|Baseline|Etanercept|Etanercept and Methotrexate
649091|NCT00405275|B1|Baseline|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
649092|NCT00405275|P2|Participant Flow|Etanercept|"Etanercept (50mg subcutaneous injections weekly); Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, triple: placebo hydroxychloroquine (tablets daily) and placebo sulfasalazine (tablets daily).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Triple. This is denoted in results table below as switch. No switch participants remained on Etanercept therapy throughout the trial."
649093|NCT00405275|P1|Participant Flow|Triple|"Hydroxychloroquine (400mg daily); Sulfasalazine (1g daily for 6 weeks, then increased to 2g daily; Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, etanercept (subcutaneous injection).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Etanercept at 24 weeks. This is denoted in results table below as switch. No switch participants remained on Triple therapy throughout the trial."
649094|NCT00405275|O2|Outcome|Etanercept|Etanercept and Methotrexate
649095|NCT00405275|O1|Outcome|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
649096|NCT00405275|E2|Reported Event|Etanercept|Etanercept and Methotrexate
649097|NCT00405275|E1|Reported Event|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
649098|NCT00405067|B4|Baseline|Total|Total of all reporting groups
649099|NCT00405067|B3|Baseline|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649100|NCT00405067|B2|Baseline|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649101|NCT00405067|B1|Baseline|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649102|NCT00405067|P3|Participant Flow|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649103|NCT00405067|P2|Participant Flow|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649104|NCT00405067|P1|Participant Flow|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649105|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649106|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649107|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649108|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649109|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649110|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649111|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649156|NCT00404924|E1|Reported Event|Vandetanib|Vandetanib 300 mg
649157|NCT00404820|B3|Baseline|Total|Total of all reporting groups
649112|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649113|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649114|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649115|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649116|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649117|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649118|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649119|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649120|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649121|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649122|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649123|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649124|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649125|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649126|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649127|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649128|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649129|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649130|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649131|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649132|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649133|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649134|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649135|NCT00405067|E3|Reported Event|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
649136|NCT00405067|E2|Reported Event|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649137|NCT00405067|E1|Reported Event|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
649138|NCT00404924|B3|Baseline|Total|Total of all reporting groups
649139|NCT00404924|B2|Baseline|Placebo|Placebo plus best supportive care
649140|NCT00404924|B1|Baseline|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649141|NCT00404924|P2|Participant Flow|Placebo|Placebo plus best supportive care
649142|NCT00404924|P1|Participant Flow|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649143|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
649144|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649145|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
649146|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649147|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
649148|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649149|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
649150|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649151|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
649152|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
649153|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
649158|NCT00404820|B2|Baseline|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649159|NCT00404820|B1|Baseline|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649160|NCT00404820|P2|Participant Flow|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649161|NCT00404820|P1|Participant Flow|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649162|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649163|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649164|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649165|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649166|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649167|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649168|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649169|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649170|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649171|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649172|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649734|NCT00402987|P2|Participant Flow|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
649173|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649174|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649175|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649176|NCT00404820|E2|Reported Event|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649177|NCT00404820|E1|Reported Event|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
649178|NCT00404768|B5|Baseline|Total|Total of all reporting groups
649179|NCT00404768|B4|Baseline|Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649180|NCT00404768|B3|Baseline|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649181|NCT00404768|B2|Baseline|Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649182|NCT00404768|B1|Baseline|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649183|NCT00404768|P4|Participant Flow|Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649184|NCT00404768|P3|Participant Flow|Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a mean steady-state concentration (Css,ave) of 75 ng/mL.
649185|NCT00404768|P2|Participant Flow|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649186|NCT00404768|P1|Participant Flow|Part A/B: IV GSK221149A|Eligible participants received a single intravenous (IV) infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 milligrams (mg) matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 nanogram/milliliter (ng/mL).
649187|NCT00404768|O2|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649188|NCT00404768|O1|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649189|NCT00404768|O2|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649190|NCT00404768|O1|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649191|NCT00404768|O2|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649192|NCT00404768|O1|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649193|NCT00404768|O2|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649194|NCT00404768|O1|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649195|NCT00404768|O2|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649196|NCT00404768|O1|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649197|NCT00404768|O2|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649198|NCT00404768|O1|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649871|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
649199|NCT00404768|O1|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649200|NCT00404768|O1|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649201|NCT00404768|O1|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649202|NCT00404768|O2|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649203|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649204|NCT00404768|O2|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649205|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649206|NCT00404768|O2|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649207|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649208|NCT00404768|O2|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649209|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649210|NCT00404768|O2|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649211|NCT00404768|O1|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649212|NCT00404768|O4|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649213|NCT00404768|O3|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649214|NCT00404768|O2|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649215|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649216|NCT00404768|O4|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649217|NCT00404768|O3|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649218|NCT00404768|O2|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649219|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649220|NCT00404768|O2|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649221|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL
649222|NCT00404768|O4|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649223|NCT00404768|O3|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649872|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
649224|NCT00404768|O2|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649225|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649226|NCT00404768|O4|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649227|NCT00404768|O3|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649228|NCT00404768|O2|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649229|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649230|NCT00404768|O4|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649231|NCT00404768|O3|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649232|NCT00404768|O2|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649233|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649234|NCT00404768|O4|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649235|NCT00404768|O3|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649236|NCT00404768|O2|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649237|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649238|NCT00404768|O4|Outcome|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649239|NCT00404768|O3|Outcome|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649240|NCT00404768|O2|Outcome|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649241|NCT00404768|O1|Outcome|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649242|NCT00404768|E4|Reported Event|Part C: Placebo|Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours.
649243|NCT00404768|E3|Reported Event|Part A/B: Oral GSK221149A|Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion.
649244|NCT00404768|E2|Reported Event|Part C: Active (GSK221149A)|Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL.
649245|NCT00404768|E1|Reported Event|Part A/B: IV GSK221149A|Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL.
649246|NCT00404755|B1|Baseline|Bupropion|"bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
649247|NCT00404755|P1|Participant Flow|Bupropion|"this was the initial treatment given to all patients except one who was ineligible for bupropion and received escitalopram~bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
649248|NCT00404755|O3|Outcome|Imipramine|"imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted~imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted"
649735|NCT00402987|P1|Participant Flow|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649249|NCT00404755|O2|Outcome|Escitalopram|"escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d~escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d"
649250|NCT00404755|O1|Outcome|Bupropion|"bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
649251|NCT00404755|O3|Outcome|Imipramine|"imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted~imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted"
649252|NCT00404755|O2|Outcome|Escitalopram|"escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d~escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d"
649253|NCT00404755|O1|Outcome|Bupropion|"bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
649254|NCT00404755|E3|Reported Event|Imipramine|"imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted~imipramine: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted"
649255|NCT00404755|E2|Reported Event|Bupropion|"bupropion XL 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted~bupropion: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d"
649256|NCT00404755|E1|Reported Event|Escitalopram|"escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d~escitalopram: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d"
649257|NCT00404651|B5|Baseline|Total|Total of all reporting groups
649258|NCT00404651|B4|Baseline|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649259|NCT00404651|B3|Baseline|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649260|NCT00404651|B2|Baseline|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649261|NCT00404651|B1|Baseline|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649262|NCT00404651|P4|Participant Flow|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649263|NCT00404651|P3|Participant Flow|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649264|NCT00404651|P2|Participant Flow|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649265|NCT00404651|P1|Participant Flow|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649266|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649267|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649268|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649269|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649489|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649270|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649271|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649272|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649273|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649274|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649275|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649276|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649277|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649278|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649279|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649280|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649281|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649282|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649283|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649284|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649285|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649286|NCT00404651|E4|Reported Event|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
649287|NCT00404651|E3|Reported Event|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649288|NCT00404651|E2|Reported Event|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
649289|NCT00404651|E1|Reported Event|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
649290|NCT00404547|B3|Baseline|Total|Total of all reporting groups
649291|NCT00404547|B2|Baseline|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
649292|NCT00404547|B1|Baseline|Alvesco|320 mcg/day or 640 mcg/day
649293|NCT00404547|P2|Participant Flow|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
649294|NCT00404547|P1|Participant Flow|Alvesco|320 mcg/day or 640 mcg/day
649295|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
649296|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
649297|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
649298|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
649299|NCT00404547|E2|Reported Event|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
649300|NCT00404547|E1|Reported Event|Alvesco|320 mcg/day or 640 mcg/day
649301|NCT00404495|B3|Baseline|Total|Total of all reporting groups
649302|NCT00404495|B2|Baseline|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649303|NCT00404495|B1|Baseline|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649304|NCT00404495|P2|Participant Flow|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649305|NCT00404495|P1|Participant Flow|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649306|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649307|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649308|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649309|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649310|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649311|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649312|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649313|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649314|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649315|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649316|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649317|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649318|NCT00404495|E2|Reported Event|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
649736|NCT00402987|O4|Outcome|Placebo|
649319|NCT00404495|E1|Reported Event|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
649320|NCT00404352|B4|Baseline|Total|Total of all reporting groups
649321|NCT00404352|B3|Baseline|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649322|NCT00404352|B2|Baseline|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649323|NCT00404352|B1|Baseline|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
649324|NCT00404352|P9|Participant Flow|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649325|NCT00404352|P8|Participant Flow|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649326|NCT00404352|P7|Participant Flow|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649327|NCT00404352|P6|Participant Flow|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
649328|NCT00404352|P5|Participant Flow|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
649329|NCT00404352|P4|Participant Flow|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
649330|NCT00404352|P3|Participant Flow|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649331|NCT00404352|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649332|NCT00404352|P1|Participant Flow|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
649333|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649334|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649335|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649490|NCT00403767|E2|Reported Event|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649873|NCT00402987|O3|Outcome|Placebo|
649336|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649337|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649338|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649339|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649340|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649341|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649342|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649343|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649344|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649345|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649346|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649347|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649348|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649349|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649367|NCT00404248|P9|Participant Flow|Arm 9 - Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day. New formulation TC6."
649350|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
649351|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649352|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649353|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
649354|NCT00404352|E9|Reported Event|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649355|NCT00404352|E8|Reported Event|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649356|NCT00404352|E7|Reported Event|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
649357|NCT00404352|E6|Reported Event|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
649358|NCT00404352|E5|Reported Event|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
649359|NCT00404352|E4|Reported Event|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
649360|NCT00404352|E3|Reported Event|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649361|NCT00404352|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649362|NCT00404352|E1|Reported Event|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
649363|NCT00404248|B4|Baseline|Total|Total of all reporting groups
649364|NCT00404248|B3|Baseline|Arm 3 no Stratification (+EIASD or -EIASD)|"Subjects were not stratified by antiseizure drugs~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Only dose tested: 2200.~NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649365|NCT00404248|B2|Baseline|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649366|NCT00404248|B1|Baseline|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649486|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649491|NCT00403767|E1|Reported Event|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
649368|NCT00404248|P8|Participant Flow|Arm 8 -EIASD Level 4|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
649369|NCT00404248|P7|Participant Flow|Arm 7 -EIASD Level 3|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation. this Arm including pts treated at the new formulation TC6 at 1700mg~PK data will be collected on day one of cycle one infusion"
649370|NCT00404248|P6|Participant Flow|Arm 6 -EIASD Level 2|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
649371|NCT00404248|P5|Participant Flow|Arm 5 Non-Enzyme Inducing Antiseizure Drug (-EIASD) Level 1|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
649372|NCT00404248|P4|Participant Flow|Arm 4 +EIASD Level 4|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation."
649373|NCT00404248|P3|Participant Flow|Arm 3 +EIASD Level 3|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation. Includes pts at the new formulation TC6 at 1700mg"
649374|NCT00404248|P2|Participant Flow|Arm 2 +EIASD Level 2|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation."
649375|NCT00404248|P1|Participant Flow|Arm 1 Enzyme Inducing Antiseizure Drug (+ EIASD) Level 1|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~Pharmacokinetics (PK) data will be collected on day one of cycle one infusion"
649376|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649377|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649378|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649379|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649380|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649381|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649382|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649487|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649383|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
649384|NCT00404248|O9|Outcome|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG. (polyethylene glycol )"
649385|NCT00404248|O8|Outcome|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649386|NCT00404248|O7|Outcome|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation and new TC6 -PEG Formulation - Pts treated from both formulations"
649387|NCT00404248|O6|Outcome|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649388|NCT00404248|O5|Outcome|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649389|NCT00404248|O4|Outcome|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649390|NCT00404248|O3|Outcome|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes patientss at the new formulation TC6 (-PEG)"
649391|NCT00404248|O2|Outcome|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649392|NCT00404248|O1|Outcome|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649393|NCT00404248|O3|Outcome|ARM 3 (No Stratification)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6."
649394|NCT00404248|O2|Outcome|ARM 2 -EIASD (Enzyme-inducing Antizeizure Drug)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
649395|NCT00404248|O1|Outcome|Arm 1 +EIASD (Enzyme-inducing Antizeizure Drug)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
649396|NCT00404248|E9|Reported Event|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-seizure medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG."
649397|NCT00404248|E8|Reported Event|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649398|NCT00404248|E7|Reported Event|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
649488|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649399|NCT00404248|E6|Reported Event|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649400|NCT00404248|E5|Reported Event|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649401|NCT00404248|E4|Reported Event|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649402|NCT00404248|E3|Reported Event|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes pts at the new formulation TC6 (-PEG)"
649403|NCT00404248|E2|Reported Event|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649404|NCT00404248|E1|Reported Event|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
649405|NCT00404092|B5|Baseline|Total|Total of all reporting groups
649406|NCT00404092|B4|Baseline|4th Cohort|"200mg 1x/day~caspofungin : i.v."
649407|NCT00404092|B3|Baseline|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
649408|NCT00404092|B2|Baseline|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
649409|NCT00404092|B1|Baseline|1st Cohort|"70mg 1x/day~caspofungin : i.v."
649410|NCT00404092|P4|Participant Flow|4th Cohort|"200mg 1x/day~caspofungin : i.v."
649411|NCT00404092|P3|Participant Flow|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
649412|NCT00404092|P2|Participant Flow|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
649413|NCT00404092|P1|Participant Flow|1st Cohort|"70mg 1x/day~caspofungin : i.v."
649414|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day~caspofungin : i.v."
649415|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
649416|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
649417|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day~caspofungin : i.v."
649418|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day~caspofungin : i.v."
649419|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
649420|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
649421|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day~caspofungin : i.v."
649422|NCT00404092|E4|Reported Event|4th Cohort|"200mg 1x/day~caspofungin : i.v."
649423|NCT00404092|E3|Reported Event|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
649424|NCT00404092|E2|Reported Event|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
649425|NCT00404092|E1|Reported Event|1st Cohort|"70mg 1x/day~caspofungin : i.v."
649426|NCT00404079|B3|Baseline|Total|Total of all reporting groups
649427|NCT00404079|B2|Baseline|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
649428|NCT00404079|B1|Baseline|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
649429|NCT00404079|P2|Participant Flow|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
649430|NCT00404079|P1|Participant Flow|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
649431|NCT00404079|O2|Outcome|Glucosamine Sulphate|Glucosamine sulphate was taken daily and orally in capsule forms for 6 months
649432|NCT00404079|O1|Outcome|Placebo|Oral intake of placebo capsules
649433|NCT00404079|E2|Reported Event|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
649434|NCT00404079|E1|Reported Event|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
649435|NCT00404066|B1|Baseline|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
649436|NCT00404066|P1|Participant Flow|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
649437|NCT00404066|O1|Outcome|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
649737|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
649438|NCT00404066|O1|Outcome|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
649439|NCT00404066|E1|Reported Event|Neoadjuvant Chemotherapy|Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
649440|NCT00403845|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649441|NCT00403845|P4|Participant Flow|Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo|In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649442|NCT00403845|P3|Participant Flow|Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg|In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649443|NCT00403845|P2|Participant Flow|Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg|In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649444|NCT00403845|P1|Participant Flow|Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg|In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649445|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649446|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649447|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649448|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649449|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649450|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649451|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649452|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649453|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649644|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649454|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649455|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649456|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649457|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649458|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649459|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649460|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649461|NCT00403845|E4|Reported Event|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649462|NCT00403845|E3|Reported Event|Indacaterol 300 μg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649463|NCT00403845|E2|Reported Event|Indacaterol 150 μg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649464|NCT00403845|E1|Reported Event|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
649465|NCT00403767|B3|Baseline|Total|Total of all reporting groups
649466|NCT00403767|B2|Baseline|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649467|NCT00403767|B1|Baseline|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
649468|NCT00403767|P2|Participant Flow|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649469|NCT00403767|P1|Participant Flow|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
649470|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649471|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649472|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649473|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649474|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649475|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649476|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649477|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649478|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649479|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649480|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649481|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649482|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649483|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649484|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
649485|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
649492|NCT00403754|B1|Baseline|Entire Study Population|"The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649493|NCT00403754|P4|Participant Flow|Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol|"In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
649494|NCT00403754|P3|Participant Flow|Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
649495|NCT00403754|P2|Participant Flow|Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649496|NCT00403754|P1|Participant Flow|Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol|"In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649497|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649498|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649499|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649500|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649501|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649638|NCT00403273|O1|Outcome|WOMAC Pain Responder|A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
649502|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649503|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649504|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649505|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649506|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649507|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649508|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649509|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649510|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649511|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649512|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649513|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649514|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649515|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649516|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649517|NCT00403754|E5|Reported Event|Salmeterol 100 μg|Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
649738|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
649518|NCT00403754|E4|Reported Event|Placebo|"2 Placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Placebo treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649519|NCT00403754|E3|Reported Event|Indacaterol 600 μg|"2 Indacaterol 300 μg capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 600 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649520|NCT00403754|E2|Reported Event|Indacaterol 300 μg|"1 Indacaterol 300 μg capsules + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 300 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649521|NCT00403754|E1|Reported Event|Indacaterol 150 μg|"1 Indacaterol 150 μg capsule + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 150 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
649522|NCT00403585|B1|Baseline|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649523|NCT00403585|P1|Participant Flow|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649524|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649525|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649526|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649527|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649528|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649529|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649530|NCT00403585|E1|Reported Event|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
649531|NCT00403546|B3|Baseline|Total|Total of all reporting groups
649532|NCT00403546|B2|Baseline|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649533|NCT00403546|B1|Baseline|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649534|NCT00403546|P3|Participant Flow|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649535|NCT00403546|P2|Participant Flow|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649536|NCT00403546|P1|Participant Flow|Standard Treatment Ziprasidone|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial. Participants who were already taking standard treatment ziprasidone for 3 weeks or longer at time of enrollment were eligible for screening, as well.
649537|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649538|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649539|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649540|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649639|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649645|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649541|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649542|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649543|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649544|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649545|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649546|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649547|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649548|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649549|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649550|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649551|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649552|NCT00403546|O1|Outcome|High Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649553|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649554|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649555|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649640|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649641|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649556|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649557|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649558|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649559|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649560|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649561|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649562|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649563|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649564|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649565|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649566|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649567|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649568|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649569|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649570|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649642|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649643|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649739|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
649571|NCT00403546|E4|Reported Event|Placebo, Standard Treatment Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
649572|NCT00403546|E3|Reported Event|High-Dose Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
649573|NCT00403546|E2|Reported Event|Standard Treatment Ziprasidone Screening Phase|Participants who had taken standard treatment ziprasidone for 3 weeks or longer were eligible for screening to enter the randomized trial.
649574|NCT00403546|E1|Reported Event|Standard Treatment Ziprasidone Open-label Phase|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial.
649575|NCT00403481|B1|Baseline|Active Treatmant Arm|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
649576|NCT00403481|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
649577|NCT00403481|O1|Outcome|Overall Study Population|
649578|NCT00403481|O1|Outcome|Overall Study Population|
649579|NCT00403481|O1|Outcome|Overall Study Population|
649580|NCT00403481|O1|Outcome|Overall Study Population|
649581|NCT00403481|O1|Outcome|Overall Study Population|
649582|NCT00403481|O1|Outcome|Overall Study Population|
649583|NCT00403481|O1|Outcome|Overall Study Population|
649584|NCT00403481|O1|Outcome|Overall Study Population|
649585|NCT00403481|O1|Outcome|Overall Study Population|
649586|NCT00403481|E4|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 25 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
649587|NCT00403481|E3|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
649588|NCT00403481|E2|Reported Event|Olmesartan 40 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
649589|NCT00403481|E1|Reported Event|Olmesartan 20 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
649590|NCT00403455|B1|Baseline|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
649591|NCT00403455|P1|Participant Flow|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
649592|NCT00403455|O1|Outcome|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
649593|NCT00403455|E1|Reported Event|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
649594|NCT00403403|B3|Baseline|Total|Total of all reporting groups
649740|NCT00402987|O4|Outcome|Placebo|
649741|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
649595|NCT00403403|B2|Baseline|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649596|NCT00403403|B1|Baseline|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649597|NCT00403403|P2|Participant Flow|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649598|NCT00403403|P1|Participant Flow|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649599|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649600|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649601|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649602|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649603|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649604|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649605|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649606|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649742|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
649743|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
649607|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649608|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649609|NCT00403403|E2|Reported Event|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649610|NCT00403403|E1|Reported Event|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
649611|NCT00403390|B3|Baseline|Total|Total of all reporting groups
649612|NCT00403390|B2|Baseline|Group 2|Generic levothyroxine 8 weeks, then branded Synthroid 8 weeks
649613|NCT00403390|B1|Baseline|Group 1|Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
649614|NCT00403390|P2|Participant Flow|Group 2|Generic levothyroxine for 8 weeks then branded Synthroid for 8 weeks
649615|NCT00403390|P1|Participant Flow|Group 1|Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
649616|NCT00403390|O2|Outcome|Group 2|Generic levothyroxine 8 weeks, then Branded Synthroid 8 weeks
649617|NCT00403390|O1|Outcome|Group 1|Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
649618|NCT00403390|E2|Reported Event|Group 2|Crossover; Generic levothyroxine 8 weeks, then Branded Synthroid 8 weeks, then generic
649619|NCT00403390|E1|Reported Event|Group 1|Crossover; Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
649620|NCT00403273|B3|Baseline|Total|Total of all reporting groups
649621|NCT00403273|B2|Baseline|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649622|NCT00403273|B1|Baseline|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649623|NCT00403273|P2|Participant Flow|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649624|NCT00403273|P1|Participant Flow|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649625|NCT00403273|O2|Outcome|WOMAC Pain Non-responder|A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
649626|NCT00403273|O1|Outcome|WOMAC Pain Responder|A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
649627|NCT00403273|O2|Outcome|WOMAC Pain Non-responder|A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
649628|NCT00403273|O1|Outcome|WOMAC Pain Responder|A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
649629|NCT00403273|O2|Outcome|WOMAC Pain Non-responder|A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
649630|NCT00403273|O1|Outcome|WOMAC Pain Responder|A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
649631|NCT00403273|O2|Outcome|WOMAC Pain Non-responder|A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
649632|NCT00403273|O1|Outcome|WOMAC Pain Responder|A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
649633|NCT00403273|O2|Outcome|WOMAC Pain Non-responder|A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
649634|NCT00403273|O1|Outcome|WOMAC Pain Responder|A patient was labeled as a WOMAC Pain responder if the WOMAC pain subscale score decreased by 20 or more on a 0-100 scale from baseline to 2-month follow-up visit.
649635|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649636|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649637|NCT00403273|O2|Outcome|WOMAC Pain Non-responder|A patient was labeled as a WOMAC Pain non-responder if the WOMAC pain subscale score decreased by 19 or less on a 0-100 scale from baseline to 2-month follow-up visit.
649726|NCT00403117|E1|Reported Event|Placebo + Inactive Marijuana (0.0%THC)|In this arm, participants received placebo + inactive marijuana (0.0%THC)
649646|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649647|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649648|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649649|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649650|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649651|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649652|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649653|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649654|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649655|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649656|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649657|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649658|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649659|NCT00403273|E2|Reported Event|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
649660|NCT00403273|E1|Reported Event|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
649661|NCT00403234|B5|Baseline|Total|Total of all reporting groups
649662|NCT00403234|B4|Baseline|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
649663|NCT00403234|B3|Baseline|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
649664|NCT00403234|B2|Baseline|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
649665|NCT00403234|B1|Baseline|Placebo|Placebo transdermal patch applied for 7-day wear
649666|NCT00403234|P4|Participant Flow|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
649667|NCT00403234|P3|Participant Flow|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
649668|NCT00403234|P2|Participant Flow|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
649669|NCT00403234|P1|Participant Flow|Placebo|Placebo transdermal patch applied for 7-day wear.
649670|NCT00403234|O4|Outcome|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
649671|NCT00403234|O3|Outcome|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
649672|NCT00403234|O2|Outcome|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
649673|NCT00403234|O1|Outcome|Placebo|Placebo transdermal patch applied for 7-day wear
649674|NCT00403234|E4|Reported Event|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
649675|NCT00403234|E3|Reported Event|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
649676|NCT00403234|E2|Reported Event|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
649677|NCT00403234|E1|Reported Event|Placebo|Placebo transdermal patch applied for 7-day wear.
649678|NCT00403130|B1|Baseline|Gemcitabine + Paclitaxel + Bevacizumab|
649679|NCT00403130|P1|Participant Flow|Gemcitabine + Paclitaxel + Bevacizumab|
649680|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
649681|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
649682|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
649683|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
649684|NCT00403130|E1|Reported Event|Gemcitabine + Paclitaxel + Bevacizumab|
649685|NCT00403117|B1|Baseline|Overall Number of Baseline Participants|Baseline measures are only reported for the 29 participants who completed the study.
649686|NCT00403117|P1|Participant Flow|Overall Study Participant Flow|Of the 49 participants enrolled, only 29 completed all 10 drug interventions.
649687|NCT00403117|O10|Outcome|Naltrexone (100mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649688|NCT00403117|O9|Outcome|Naltrexone (100mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649689|NCT00403117|O8|Outcome|Naltrexone (50mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649690|NCT00403117|O7|Outcome|Naltrexone (50mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649691|NCT00403117|O6|Outcome|Naltrexone (25mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649692|NCT00403117|O5|Outcome|Naltrexone (25mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649693|NCT00403117|O4|Outcome|Naltrexone (12mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649694|NCT00403117|O3|Outcome|Naltrexone (12mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649727|NCT00402987|B5|Baseline|Total|Total of all reporting groups
649728|NCT00402987|B4|Baseline|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
649729|NCT00402987|B3|Baseline|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649730|NCT00402987|B2|Baseline|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
649731|NCT00402987|B1|Baseline|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649695|NCT00403117|O2|Outcome|Placebo + Marijuana (3.27% THC)|"Placebo marijuana (3.27% THC)~Naltrexone: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.~Marijuana: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak."
649696|NCT00403117|O1|Outcome|Placebo + Marijuana (0.0%THC)|"Placebo Inactive marijuana (0.0% THC)~Naltrexone: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.~Marijuana: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak."
649697|NCT00403117|O10|Outcome|Naltrexone (100mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649698|NCT00403117|O9|Outcome|Naltrexone (100mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649699|NCT00403117|O8|Outcome|Naltrexone (50mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649700|NCT00403117|O7|Outcome|Naltrexone (50mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649701|NCT00403117|O6|Outcome|Naltrexone (25mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649702|NCT00403117|O5|Outcome|Naltrexone (25mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649703|NCT00403117|O4|Outcome|Naltrexone (12mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649704|NCT00403117|O3|Outcome|Naltrexone (12mg) + Marijuana (0.0%THC)|Naltrexone + Inactive marijuana
649705|NCT00403117|O2|Outcome|Placebo + Marijuana (3.27% THC)|"Placebo marijuana (3.27% THC)~Naltrexone: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.~Marijuana: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak."
649706|NCT00403117|O1|Outcome|Placebo + Marijuana (0.0%THC)|"Placebo Inactive marijuana (0.0% THC)~Naltrexone: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak.~Marijuana: During each session, one capsule containing placebo or naltrexone (12, 25, 50, and 100 mg) was administered to the participant in a size 00 opaque capsules with lactose filler, prepared by the New York State Psychiatric Institute Research Pharmacy. A marijuana cigarette (0 or 3.27% THC; ca. 800 mg) provided by the National Institute on Drug Abuse was smoked 45 min after naltrexone administration, the time at which naltrexone levels peak."
649707|NCT00403117|O10|Outcome|Naltrexone (100mg) + Marijuana (3.27%THC)|naltrexone + active marijuana
649708|NCT00403117|O9|Outcome|Naltrexone (100mg) + Marijuana (0.0%THC)|Naltrexone (100mg) + marijuana (0.0%THC)
649709|NCT00403117|O8|Outcome|Naltrexone (50mg) + Marijuana (3.27%THC)|Naltrexone (50mg) + marijuana (3.27%THC)
649710|NCT00403117|O7|Outcome|Naltrexone (50mg) + Marijuana (0.0%THC)|Naltrexone (50mg) + marijuana (0.0%THC)
649711|NCT00403117|O6|Outcome|Naltrexone (25mg) + Marijuana (3.27%THC)|Naltrexone (25mg) + marijuana (3.27%THC)
649712|NCT00403117|O5|Outcome|Naltrexone (25mg) + Marijuana (0.0%THC)|Naltrexone (25mg) + marijuana (0.0%THC)
649713|NCT00403117|O4|Outcome|Naltrexone (12mg) + Marijuana (3.27%THC)|Naltrexone (12mg) + marijuana (3.27%THC)
649714|NCT00403117|O3|Outcome|Naltrexone (12mg) + Marijuana (0.0%THC)|Naltrexone (12mg) + marijuana (0.0%THC)
649715|NCT00403117|O2|Outcome|Placebo + Marijuana (3.27% THC)|Placebo + Marijuana (3.27% THC)
649716|NCT00403117|O1|Outcome|Placebo + Marijuana (0.0%THC)|Placebo + Marijuana (0.0%THC)
649717|NCT00403117|E10|Reported Event|Naltrexone (100mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (100mg) + marijuana (3.27%THC)
649718|NCT00403117|E9|Reported Event|Naltrexone (100mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (100mg) + marijuana (0.0%THC)
649719|NCT00403117|E8|Reported Event|Naltrexone (50mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (50mg) + marijuana (3.27%THC)
649720|NCT00403117|E7|Reported Event|Naltrexone (50mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (50mg) + marijuana (0.0%THC)
649721|NCT00403117|E6|Reported Event|Naltrexone (25mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (25mg) + marijuana (3.27%THC)
649722|NCT00403117|E5|Reported Event|Naltrexone (25mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (25mg) + marijuana (0.0%THC)
649723|NCT00403117|E4|Reported Event|Naltrexone (12mg) + Marijuana (3.27%THC)|In this arm, participants received naltrexone (12mg) + marijuana (3.27%THC)
649724|NCT00403117|E3|Reported Event|Naltrexone (12mg) + Marijuana (0.0%THC)|In this arm, participants received naltrexone (12mg) + marijuana (0.0%THC)
649725|NCT00403117|E2|Reported Event|Placebo + Marijuana (3.27% THC)|In this arm, participants received placebo + Marijuana (3.27% THC)
649874|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
649875|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
649876|NCT00402987|O4|Outcome|Placebo|
649877|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
649878|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
649879|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
649880|NCT00402987|O3|Outcome|Placebo|
649881|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
649882|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
649883|NCT00402987|O4|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
649884|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649885|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
649886|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649887|NCT00402987|O3|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
649888|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
649889|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649890|NCT00402987|O2|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
649891|NCT00402987|O1|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
649892|NCT00402987|E4|Reported Event|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
649893|NCT00402987|E3|Reported Event|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649894|NCT00402987|E2|Reported Event|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
649895|NCT00402987|E1|Reported Event|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
649896|NCT00402896|B1|Baseline|ZD6474|300 mg/day orally for 10 weeks.
649897|NCT00402896|P1|Participant Flow|ZD6474|300 mg/day orally for 10 weeks.
649898|NCT00402896|O1|Outcome|ZD6474|300 mg/day orally for 10 weeks.
649899|NCT00402896|E1|Reported Event|ZD6474|300 mg/day orally for 10 weeks.
649900|NCT00402883|B1|Baseline|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
649901|NCT00402883|P1|Participant Flow|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|"Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines.~Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy."
649902|NCT00402883|O1|Outcome|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
649903|NCT00402883|E1|Reported Event|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
649904|NCT00402740|B1|Baseline|Group 1|
649905|NCT00402740|P1|Participant Flow|Group 1|
649906|NCT00402740|O1|Outcome|Group 1|
649907|NCT00402740|O1|Outcome|Group 1|
649908|NCT00402740|O1|Outcome|Group 1|
649909|NCT00402740|O3|Outcome|Emboshield Gen 3|Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
649910|NCT00402740|O2|Outcome|Emboshield Pro Gen 5|Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.
649911|NCT00402740|O1|Outcome|Xact Stent|The Xact stent success were counted per subject
649912|NCT00402740|O1|Outcome|Group 1|Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.
649913|NCT00402740|E1|Reported Event|Group 1|
649914|NCT00402727|B3|Baseline|Total|Total of all reporting groups
649915|NCT00402727|B2|Baseline|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649916|NCT00402727|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649917|NCT00402727|P2|Participant Flow|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649918|NCT00402727|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649919|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649920|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649921|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649922|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649923|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649924|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649925|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649926|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649927|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649928|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649929|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649930|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649931|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649932|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649933|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649934|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649935|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649936|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649937|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649938|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649939|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649940|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649976|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649941|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649942|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649943|NCT00402727|E2|Reported Event|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
649944|NCT00402727|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
649945|NCT00402714|B3|Baseline|Total|Total of all reporting groups
649946|NCT00402714|B2|Baseline|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649947|NCT00402714|B1|Baseline|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649948|NCT00402714|P2|Participant Flow|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649949|NCT00402714|P1|Participant Flow|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649950|NCT00402714|O2|Outcome|Pento TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649951|NCT00402714|O1|Outcome|ECP Pento TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649952|NCT00402714|O2|Outcome|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649953|NCT00402714|O1|Outcome|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649954|NCT00402714|E2|Reported Event|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649955|NCT00402714|E1|Reported Event|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
649956|NCT00402688|B4|Baseline|Total|Total of all reporting groups
649957|NCT00402688|B3|Baseline|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649958|NCT00402688|B2|Baseline|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649959|NCT00402688|B1|Baseline|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649960|NCT00402688|P3|Participant Flow|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649961|NCT00402688|P2|Participant Flow|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649962|NCT00402688|P1|Participant Flow|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649963|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649964|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649965|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649966|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649967|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649968|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649969|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649970|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649971|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649972|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649973|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649974|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649975|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
650029|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
649977|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649978|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649979|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649980|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649981|NCT00402688|E3|Reported Event|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
649982|NCT00402688|E2|Reported Event|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
649983|NCT00402688|E1|Reported Event|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
649984|NCT00402649|B1|Baseline|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649985|NCT00402649|P1|Participant Flow|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649986|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649987|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649988|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649989|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649990|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649991|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649992|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649993|NCT00402649|E1|Reported Event|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
649994|NCT00402597|B6|Baseline|Total|Total of all reporting groups
649995|NCT00402597|B5|Baseline|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
649996|NCT00402597|B4|Baseline|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
649997|NCT00402597|B3|Baseline|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
649998|NCT00402597|B2|Baseline|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
649999|NCT00402597|B1|Baseline|Placebo|One placebo tablet twice daily for 6 months.
650000|NCT00402597|P5|Participant Flow|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650001|NCT00402597|P4|Participant Flow|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650002|NCT00402597|P3|Participant Flow|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650003|NCT00402597|P2|Participant Flow|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
650004|NCT00402597|P1|Participant Flow|Placebo|One placebo tablet twice daily for 6 months.
650005|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650006|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650007|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650008|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
650009|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
650010|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650011|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650012|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650013|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
650014|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
650015|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650016|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650017|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650018|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
650019|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
650020|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650021|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650022|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650023|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
650024|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
650025|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650026|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650027|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650028|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
650030|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650031|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650032|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650033|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
650034|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
650035|NCT00402597|E5|Reported Event|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
650036|NCT00402597|E4|Reported Event|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
650037|NCT00402597|E3|Reported Event|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
650038|NCT00402597|E2|Reported Event|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
650039|NCT00402597|E1|Reported Event|Placebo|One placebo tablet twice daily for 6 months.
650040|NCT00402363|B5|Baseline|Total|Total of all reporting groups
650041|NCT00402363|B4|Baseline|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
650042|NCT00402363|B3|Baseline|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
650043|NCT00402363|B2|Baseline|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
650044|NCT00402363|B1|Baseline|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
650045|NCT00402363|P4|Participant Flow|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
650046|NCT00402363|P3|Participant Flow|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
650047|NCT00402363|P2|Participant Flow|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
650048|NCT00402363|P1|Participant Flow|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
650049|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650050|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650051|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650052|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650053|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650054|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650055|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650056|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650057|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650058|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650059|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650060|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650061|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
651438|NCT00399360|B5|Baseline|Total|Total of all reporting groups
650062|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650063|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650064|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650065|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650066|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650067|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650068|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650069|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650070|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650071|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650072|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650073|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650074|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650075|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650076|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650077|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650078|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650079|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650080|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650081|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650082|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650083|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650084|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650085|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650086|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650087|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650088|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650089|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650090|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650091|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650092|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
650093|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650094|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650095|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650096|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650097|NCT00402363|O4|Outcome|Combined, P-OM3|Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650098|NCT00402363|O3|Outcome|Combined, Placebo|Participants with both paroxysmal and persistent AF receiving matching placebo
650099|NCT00402363|O2|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650100|NCT00402363|O1|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
650101|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650102|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
650103|NCT00402363|E2|Reported Event|Prescription Omega-3 Acid Ethyl Esters|Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
650104|NCT00402363|E1|Reported Event|Placebo|Participants receiving matching placebo
650105|NCT00402337|B6|Baseline|Total|Total of all reporting groups
650106|NCT00402337|B5|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
650107|NCT00402337|B4|Baseline|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650108|NCT00402337|B3|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650109|NCT00402337|B2|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day. One patient was randomized into the study but did not receive ≥ 1 dose of study drug, thus was not included in the Safety Population.
650110|NCT00402337|B1|Baseline|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650111|NCT00402337|P5|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
650112|NCT00402337|P4|Participant Flow|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650113|NCT00402337|P3|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650114|NCT00402337|P2|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650115|NCT00402337|P1|Participant Flow|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650116|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
650117|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650118|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650119|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650120|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650121|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
650122|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650123|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650124|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650125|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650126|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
650127|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650128|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650129|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650130|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650131|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
650132|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650133|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650134|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650135|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650136|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
650137|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650138|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650139|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650140|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650141|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
650142|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650143|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650144|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650145|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650146|NCT00402337|E5|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
650147|NCT00402337|E4|Reported Event|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
650148|NCT00402337|E3|Reported Event|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
650149|NCT00402337|E2|Reported Event|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
650150|NCT00402337|E1|Reported Event|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
650151|NCT00402324|B3|Baseline|Total|Total of all reporting groups
650152|NCT00402324|B2|Baseline|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650153|NCT00402324|B1|Baseline|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650154|NCT00402324|P2|Participant Flow|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650155|NCT00402324|P1|Participant Flow|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650156|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
651677|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
650157|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650158|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650159|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650160|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650161|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650162|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650163|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650164|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650165|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650166|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650167|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650168|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650169|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650170|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650171|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650172|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650173|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650174|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650175|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650176|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650177|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650178|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650179|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650266|NCT00402194|E2|Reported Event|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
650180|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
650181|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
650182|NCT00402324|E2|Reported Event|Placebo|Placebo: placebo capsules, PO, at Q HS, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following dose achieved in Study Period I).
650183|NCT00402324|E1|Reported Event|Olanzapine|Olanzapine: 15mg, capsules, PO at Q HS, daily for 1 week followed by 5-20mg, capsules, PO at Q HS daily for 5 weeks (6 weeks total). Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following d ose achieved in Study Period I)
650184|NCT00402285|B4|Baseline|Total|Total of all reporting groups
650185|NCT00402285|B3|Baseline|Placebo|men took placebo for lycopene & placebo for fish oil.
650186|NCT00402285|B2|Baseline|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
650187|NCT00402285|B1|Baseline|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
650188|NCT00402285|P3|Participant Flow|Placebo|men took placebo for lycopene & placebo for fish oil.
650189|NCT00402285|P2|Participant Flow|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
650190|NCT00402285|P1|Participant Flow|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
650191|NCT00402285|O3|Outcome|Placebo|men took placebo for lycopene & placebo for fish oil.
650192|NCT00402285|O2|Outcome|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
650193|NCT00402285|O1|Outcome|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
650194|NCT00402285|E1|Reported Event|All Participants|
650195|NCT00402246|B3|Baseline|Total|Total of all reporting groups
650196|NCT00402246|B2|Baseline|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650197|NCT00402246|B1|Baseline|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650198|NCT00402246|P2|Participant Flow|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650199|NCT00402246|P1|Participant Flow|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650200|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
650201|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
650202|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
650203|NCT00402246|O1|Outcome|Clinicians|Clinicians who responded to the survey
650204|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650205|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650206|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650234|NCT00402233|P3|Participant Flow|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650207|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650208|NCT00402246|O1|Outcome|Patients With a Study CRT-D Device|Patients in either the Remote Arm or the In-office Arm who were implanted with a study CRT-D Device, as these are the only devices that have Left Ventricular leads
650209|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650210|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650211|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650212|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650213|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650214|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650215|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650216|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650217|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650264|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
651685|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
650218|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650219|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650220|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650221|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650222|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650223|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650224|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650225|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
650226|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
650227|NCT00402246|E1|Reported Event|Enrolled Subjects|All enrolled subjects in the study
650228|NCT00402233|B5|Baseline|Total|Total of all reporting groups
650229|NCT00402233|B4|Baseline|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650230|NCT00402233|B3|Baseline|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650231|NCT00402233|B2|Baseline|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650232|NCT00402233|B1|Baseline|Placebo|matching tablet
650233|NCT00402233|P4|Participant Flow|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650265|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
650310|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650235|NCT00402233|P2|Participant Flow|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650236|NCT00402233|P1|Participant Flow|Placebo|matching tablet
650237|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650238|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650239|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650240|NCT00402233|O1|Outcome|Placebo|matching tablet
650241|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650242|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650243|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650244|NCT00402233|O1|Outcome|Placebo|matching tablet
650245|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650246|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650247|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650248|NCT00402233|O1|Outcome|Placebo|matching tablet
650249|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650250|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650251|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650252|NCT00402233|O1|Outcome|Placebo|matching tablet
650253|NCT00402233|E4|Reported Event|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650254|NCT00402233|E3|Reported Event|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650255|NCT00402233|E2|Reported Event|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
650256|NCT00402233|E1|Reported Event|Placebo|matching tablet
650257|NCT00402194|B3|Baseline|Total|Total of all reporting groups
650258|NCT00402194|B2|Baseline|Placebo|Placebo
650259|NCT00402194|B1|Baseline|Treatment|Treatment with 100mg of losartan daily or placebo. Outcomes measured before and after 3 months of treatment.
650260|NCT00402194|P2|Participant Flow|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
650261|NCT00402194|P1|Participant Flow|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
650262|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
650263|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
650267|NCT00402194|E1|Reported Event|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
650268|NCT00402168|B3|Baseline|Total|Total of all reporting groups
650269|NCT00402168|B2|Baseline|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650270|NCT00402168|B1|Baseline|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650271|NCT00402168|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650272|NCT00402168|P1|Participant Flow|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
650273|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
650274|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants who had been randomized to CNI were allowed to switch to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
650275|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650276|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650277|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650278|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650279|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650280|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650281|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650282|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650283|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650284|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650285|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650286|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650287|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650288|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650289|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650290|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650291|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650292|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650293|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650294|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650295|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650296|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650297|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650298|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650299|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650300|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650301|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650302|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650303|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650304|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650305|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650306|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650307|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650308|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg given IV every 28 days.
650309|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650311|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650312|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650313|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm by Year 3.
650314|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
650315|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650316|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650317|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650318|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650319|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650320|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
650321|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
650322|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg was given IV every 28 days.
650323|NCT00402168|E3|Reported Event|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to Belatacept. For those switching to Belatacept, the CNI dose was tapered and discontinued, after which they received Belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received Belatacept 5 mg/kg IV every 28 days. Adverse events reported for participants who were switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period on or after their first Belatacept dose.
650324|NCT00402168|E2|Reported Event|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to Belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the Belatacept arm. Adverse events reported for participants who were treated with only CNI for the entire study and those who were later switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period prior to their first Belatacept dose.
650325|NCT00402168|E1|Reported Event|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days. Adverse events reported for participants who were treated with only Belatacept throughout the study.
650326|NCT00402103|B3|Baseline|Total|Total of all reporting groups
650327|NCT00402103|B2|Baseline|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
650328|NCT00402103|B1|Baseline|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
650329|NCT00402103|P2|Participant Flow|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
650330|NCT00402103|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
650331|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
650332|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
650333|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
650334|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
650335|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
650336|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
650337|NCT00402103|O3|Outcome|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
650338|NCT00402103|O2|Outcome|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
650339|NCT00402103|O1|Outcome|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
650340|NCT00402103|E3|Reported Event|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
650341|NCT00402103|E2|Reported Event|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
650342|NCT00402103|E1|Reported Event|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
650343|NCT00402051|B3|Baseline|Total|Total of all reporting groups
650344|NCT00402051|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650345|NCT00402051|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650346|NCT00402051|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650347|NCT00402051|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650348|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650349|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650350|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650351|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650352|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650353|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650354|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650355|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650356|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650357|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650358|NCT00402051|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
650359|NCT00402051|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
650360|NCT00402025|B4|Baseline|Total|Total of all reporting groups
650361|NCT00402025|B3|Baseline|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650362|NCT00402025|B2|Baseline|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650363|NCT00402025|B1|Baseline|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650364|NCT00402025|P3|Participant Flow|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650365|NCT00402025|P2|Participant Flow|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650366|NCT00402025|P1|Participant Flow|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650367|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650368|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650438|NCT00401960|O1|Outcome|Adjunctive Daptomycin Group|please see study description for study enrollment
650439|NCT00401960|E2|Reported Event|Standard of Care Group|as per study description
650369|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650370|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650371|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650372|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650373|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650374|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650375|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650376|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650377|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650378|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650379|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650380|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650381|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650382|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650383|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650384|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650385|NCT00402025|E3|Reported Event|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650386|NCT00402025|E2|Reported Event|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650440|NCT00401960|E1|Reported Event|Adjunctive Daptomycin Group|please see study description for study enrollment
650441|NCT00401882|B3|Baseline|Total|Total of all reporting groups
651686|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
650387|NCT00402025|E1|Reported Event|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
650388|NCT00401973|B4|Baseline|Total|Total of all reporting groups
650389|NCT00401973|B3|Baseline|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650390|NCT00401973|B2|Baseline|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650391|NCT00401973|B1|Baseline|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650392|NCT00401973|P3|Participant Flow|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650393|NCT00401973|P2|Participant Flow|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650394|NCT00401973|P1|Participant Flow|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650395|NCT00401973|O2|Outcome|22 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
650396|NCT00401973|O1|Outcome|2 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
650397|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650398|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650399|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650400|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650401|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650402|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650403|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650404|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650405|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650406|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650407|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650408|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650442|NCT00401882|B2|Baseline|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
650409|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650410|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650411|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650412|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650413|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650414|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650415|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650416|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650417|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650418|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650419|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650420|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650421|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650422|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650423|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650424|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650425|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650426|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650427|NCT00401973|E3|Reported Event|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650428|NCT00401973|E2|Reported Event|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
650429|NCT00401973|E1|Reported Event|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
650430|NCT00401960|B3|Baseline|Total|Total of all reporting groups
650431|NCT00401960|B2|Baseline|Standard of Care Group|as per study description
650432|NCT00401960|B1|Baseline|Adjunctive Daptomycin Group|please see study description for study enrollment
650433|NCT00401960|P2|Participant Flow|Standard of Care Group|as per study description
650434|NCT00401960|P1|Participant Flow|Adjunctive Daptomycin Group|please see study description for study enrollment
650435|NCT00401960|O2|Outcome|Standard of Care|Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
650436|NCT00401960|O1|Outcome|Daptomycin Adjunctive Group|"Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving~Daptomycin: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis"
650437|NCT00401960|O2|Outcome|Standard of Care Group|as per study description
651687|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
650443|NCT00401882|B1|Baseline|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
650444|NCT00401882|P2|Participant Flow|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional doses of epinephrine
650445|NCT00401882|P1|Participant Flow|Additional Doses of Epinephrine|Epinephrine: additional doses Epinephrine (1 mg) IV given as part of standard of care in cardiac arrest
650446|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
650447|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
650448|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
650449|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
650450|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
650451|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
650452|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5mg IV (up to two times only) instead of additional epinephrine doses
650453|NCT00401882|O1|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine IV (1 mg) given as part of standard of care in cardiac arrest
650454|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|"IV metoprolol 5 mg. (up to 2 times only) during cardiac arrest will be given instead of additional Epinephrine doses~Metoprolol: Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses"
650455|NCT00401882|O1|Outcome|Additional Epinephrine Doses|"Additional doses of Epinephrine (1 mg) given as part of standard of care during cardiac arrest~Epinephrine: Epinephrine (1 mg) IV additional doses"
650456|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol 5 mg IV (up to 2 times) instead of additional epinephrine doses
650457|NCT00401882|O1|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine (1 mg IV) given as part of standard of care during cardiac arrest
650458|NCT00401882|E2|Reported Event|Metoprolol Instead of Additional Doses of Epinephrine|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional epinephrine doses
650459|NCT00401882|E1|Reported Event|Additional Doses of Epinephrine|Epinephrine: Additional doses epinephrine (1 mg IV) as part of standard of care during cardiac arrest
650460|NCT00401843|B4|Baseline|Total|Total of all reporting groups
650461|NCT00401843|B3|Baseline|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
650462|NCT00401843|B2|Baseline|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
650463|NCT00401843|B1|Baseline|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
650464|NCT00401843|P3|Participant Flow|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
650465|NCT00401843|P2|Participant Flow|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
650466|NCT00401843|P1|Participant Flow|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
650514|NCT00401830|E2|Reported Event|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650515|NCT00401830|E1|Reported Event|Placebo|Matching placebo tablet (administered twice daily)
650467|NCT00401843|O3|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650468|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650469|NCT00401843|O1|Outcome|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
650470|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650471|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650472|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650473|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650474|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650475|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650516|NCT00401817|B1|Baseline|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
650476|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650477|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
650478|NCT00401843|E3|Reported Event|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
650479|NCT00401843|E2|Reported Event|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
650480|NCT00401843|E1|Reported Event|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
650481|NCT00401830|B3|Baseline|Total|Total of all reporting groups
650482|NCT00401830|B2|Baseline|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650483|NCT00401830|B1|Baseline|Placebo|Matching placebo tablet (administered twice daily)
650484|NCT00401830|P2|Participant Flow|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650485|NCT00401830|P1|Participant Flow|Placebo|Matching placebo tablet (administered twice daily)
650486|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650487|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650488|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650489|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650490|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650491|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650492|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650493|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650494|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650495|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650496|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650497|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650498|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650499|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650500|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650501|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650502|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650503|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650504|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650505|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650506|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650507|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650508|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650509|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650510|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650511|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
650512|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
650513|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
652281|NCT00396877|E2|Reported Event|Clopidogrel 0.2mg/kg/Day|
650517|NCT00401817|P1|Participant Flow|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
650518|NCT00401817|O1|Outcome|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
650519|NCT00401817|O1|Outcome|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles~Rituximab: Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.~The dose to be administered is:~Rituximab: 375 mg/m2~CHOP: Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 – 7"
650520|NCT00401817|O1|Outcome|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
650521|NCT00401817|O1|Outcome|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
650522|NCT00401817|E1|Reported Event|Study Treatment Arm|"Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles~Bevacizumab: 15 mg/kg on day 1 of each of 6 cycles"
650523|NCT00401778|B4|Baseline|Total|Total of all reporting groups
650524|NCT00401778|B3|Baseline|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
650525|NCT00401778|B2|Baseline|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
650526|NCT00401778|B1|Baseline|Control|No everolimus taken.
650527|NCT00401778|P3|Participant Flow|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
650528|NCT00401778|P2|Participant Flow|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
650529|NCT00401778|P1|Participant Flow|Control|No everolimus taken.
650530|NCT00401778|O2|Outcome|Everolimus 5 or 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
650531|NCT00401778|O1|Outcome|Control|No everolimus taken.
650532|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
650533|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
650534|NCT00401778|O1|Outcome|Control|No everolimus taken.
650535|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
650536|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
650537|NCT00401778|O1|Outcome|Control|No everolimus taken.
650538|NCT00401778|E2|Reported Event|Everolimus 5 & 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
650539|NCT00401778|E1|Reported Event|Control|No everolimus taken.
650540|NCT00401752|B3|Baseline|Total|Total of all reporting groups
650541|NCT00401752|B2|Baseline|Ranitidine|ranitidine 150 mg capsule bid oral administration
650542|NCT00401752|B1|Baseline|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650543|NCT00401752|P2|Participant Flow|Ranitidine|ranitidine 150 mg capsule bid oral administration
650544|NCT00401752|P1|Participant Flow|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650545|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
650546|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650547|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
650548|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650549|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
650550|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650551|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
650552|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650553|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
650554|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650555|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
650556|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650557|NCT00401752|E2|Reported Event|Ranitidine|ranitidine 150 mg capsule bid oral administration
650558|NCT00401752|E1|Reported Event|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
650559|NCT00401726|B3|Baseline|Total|Total of all reporting groups
650560|NCT00401726|B2|Baseline|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650561|NCT00401726|B1|Baseline|Venlafaxine Extended Release (ER)|75-225 mg per day
650562|NCT00401726|P2|Participant Flow|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650563|NCT00401726|P1|Participant Flow|Venlafaxine Extended Release (ER)|75-225 mg per day
650602|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650564|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
650565|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650566|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650567|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650568|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650569|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650570|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650571|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650572|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650573|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650574|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650575|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650576|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650577|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650578|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650579|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
650580|NCT00401726|E2|Reported Event|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
650581|NCT00401726|E1|Reported Event|Venlafaxine Extended Release (ER)|75-225 mg per day
650582|NCT00401622|B3|Baseline|Total|Total of all reporting groups
650583|NCT00401622|B2|Baseline|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
650584|NCT00401622|B1|Baseline|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
650585|NCT00401622|P2|Participant Flow|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
650586|NCT00401622|P1|Participant Flow|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
650587|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
650588|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
650589|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
650590|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
650591|NCT00401622|E2|Reported Event|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
650592|NCT00401622|E1|Reported Event|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
650593|NCT00401544|B5|Baseline|Total|Total of all reporting groups
650594|NCT00401544|B4|Baseline|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650595|NCT00401544|B3|Baseline|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650596|NCT00401544|B2|Baseline|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650597|NCT00401544|B1|Baseline|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650598|NCT00401544|P4|Participant Flow|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650599|NCT00401544|P3|Participant Flow|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650600|NCT00401544|P2|Participant Flow|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650601|NCT00401544|P1|Participant Flow|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650865|NCT00400881|E2|Reported Event|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
650603|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650604|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650605|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650606|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650607|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650608|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650609|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650610|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650611|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650612|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650613|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650614|NCT00401544|O4|Outcome|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650615|NCT00401544|O3|Outcome|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650616|NCT00401544|O2|Outcome|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650617|NCT00401544|O1|Outcome|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650618|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650619|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650620|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650621|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650622|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650623|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650624|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650625|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650626|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650627|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650628|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650629|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650630|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650631|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650632|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650633|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650634|NCT00401544|E4|Reported Event|Darbepoetin Alfa 500 µg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650635|NCT00401544|E3|Reported Event|Darbepoetin Alfa 500 µg (Without Iron)|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650976|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
650636|NCT00401544|E2|Reported Event|Darbepoetin Alfa 300 µg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650637|NCT00401544|E1|Reported Event|Darbepoetin Alfa 300 µg (Without IV Iron)|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
650638|NCT00401531|B3|Baseline|Total|Total of all reporting groups
650639|NCT00401531|B2|Baseline|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650640|NCT00401531|B1|Baseline|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650641|NCT00401531|P2|Participant Flow|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650642|NCT00401531|P1|Participant Flow|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650643|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650644|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650645|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650646|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650647|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650648|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650649|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650650|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650651|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650652|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650653|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650654|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650655|NCT00401531|E2|Reported Event|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650656|NCT00401531|E1|Reported Event|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
650657|NCT00401414|B4|Baseline|Total|Total of all reporting groups
650658|NCT00401414|B3|Baseline|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
650659|NCT00401414|B2|Baseline|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
650660|NCT00401414|B1|Baseline|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
650661|NCT00401414|P3|Participant Flow|Dosing Algorithm C|Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin’s PD effect as evident in the acquired patient data. Simulations using Algorithm C were repeated using the clinical endpoints described above to derive the optimal starting warfarin doses and titration scheme that was tested prospectively in subsequent patients enrolled in the CROWN study.
650662|NCT00401414|P2|Participant Flow|Dosing Algorithm B|Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
650663|NCT00401414|P1|Participant Flow|Dosing Algorithm A|"Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
650664|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
650665|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
650666|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
650723|NCT00401245|B4|Baseline|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650724|NCT00401245|B3|Baseline|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650725|NCT00401245|B2|Baseline|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650667|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
650668|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
650669|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
650670|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
650671|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
650672|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
650673|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
650674|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
650726|NCT00401245|B1|Baseline|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650727|NCT00401245|P8|Participant Flow|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
651043|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
650675|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
650676|NCT00401414|O3|Outcome|Dosing Algorithm C|
650677|NCT00401414|O2|Outcome|Dosing Algorithm B|
650678|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
650679|NCT00401414|E3|Reported Event|Dosing Algorithm C|
650680|NCT00401414|E2|Reported Event|Dosing Algorithm B|
650681|NCT00401414|E1|Reported Event|Dosing Algorithm A|
650682|NCT00401401|B5|Baseline|Total|Total of all reporting groups
650683|NCT00401401|B4|Baseline|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
650684|NCT00401401|B3|Baseline|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
650685|NCT00401401|B2|Baseline|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
650686|NCT00401401|B1|Baseline|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
650687|NCT00401401|P4|Participant Flow|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
650688|NCT00401401|P3|Participant Flow|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
650689|NCT00401401|P2|Participant Flow|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
650690|NCT00401401|P1|Participant Flow|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
650691|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
650692|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
650693|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
650694|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
650695|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
650696|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
650697|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
650698|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
650699|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
650700|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
650701|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
650702|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
650703|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|
650704|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|
650705|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|
650706|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|
650707|NCT00401401|E4|Reported Event|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
650708|NCT00401401|E3|Reported Event|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
650709|NCT00401401|E2|Reported Event|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
650710|NCT00401401|E1|Reported Event|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
650711|NCT00401258|B1|Baseline|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650712|NCT00401258|P1|Participant Flow|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650713|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650714|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650715|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650716|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650717|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650718|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650719|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650720|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650721|NCT00401258|E1|Reported Event|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
650722|NCT00401245|B5|Baseline|Total|Total of all reporting groups
650728|NCT00401245|P7|Participant Flow|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650729|NCT00401245|P6|Participant Flow|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650730|NCT00401245|P5|Participant Flow|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally every other day (QOD) alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650731|NCT00401245|P4|Participant Flow|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650732|NCT00401245|P3|Participant Flow|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650733|NCT00401245|P2|Participant Flow|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650734|NCT00401245|P1|Participant Flow|DVS 25 mg, Then 100 mg|Desvenlafaxine succinate (DVS) 25 milligram (mg) tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week open label (OL) phase.
650735|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650736|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650737|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650738|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650739|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650740|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650741|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650742|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650743|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
650744|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
650745|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650746|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650747|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650748|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650749|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650750|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650751|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650752|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650753|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650754|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650755|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650756|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650757|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650758|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650859|NCT00400881|P2|Participant Flow|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
650759|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650760|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650761|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650762|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650763|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650764|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650765|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650766|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650767|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650768|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650769|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650770|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650771|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650772|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650773|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650774|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650775|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650776|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650777|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650778|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650779|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650780|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650781|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
650782|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650783|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650784|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650785|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650786|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650787|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650788|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
650789|NCT00401245|E9|Reported Event|Placebo (Tapering Phase)|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
651044|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
650790|NCT00401245|E8|Reported Event|DVS 50 mg/Placebo (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
650791|NCT00401245|E7|Reported Event|DVS 50/25 mg (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
650792|NCT00401245|E6|Reported Event|DVS 50 mg QOD (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
650793|NCT00401245|E5|Reported Event|DVS 100 mg (OL Phase)|After 1 week of double blind titration phase, DVS 100 mg tablet taken orally daily for 15 weeks.
650794|NCT00401245|E4|Reported Event|DVS 100 mg (Titration Phase)|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase).
650795|NCT00401245|E3|Reported Event|DVS 50 mg (Titration Phase)|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase).
650796|NCT00401245|E2|Reported Event|DVS 25/50 mg (Titration Phase)|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase).
650797|NCT00401245|E1|Reported Event|DVS 25 mg (Titration Phase)|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase).
650798|NCT00401193|B4|Baseline|Total|Total of all reporting groups
650799|NCT00401193|B3|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
650800|NCT00401193|B2|Baseline|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
650801|NCT00401193|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
650802|NCT00401193|P3|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
650803|NCT00401193|P2|Participant Flow|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
650804|NCT00401193|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
650805|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
650806|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
650807|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
650808|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
650809|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
650810|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
650811|NCT00401193|O3|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
650812|NCT00401193|O2|Outcome|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
650813|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
650814|NCT00401193|E3|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
650815|NCT00401193|E2|Reported Event|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
650816|NCT00401193|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
650817|NCT00401102|B1|Baseline|Group 1|All participants recieved Interpersonal psychotherapy
650818|NCT00401102|P1|Participant Flow|Group 1|All participants recieved Interpersonal psychotherapy
650819|NCT00401102|O1|Outcome|Group 1|All participants recieved Interpersonal psychotherapy
650820|NCT00401102|E1|Reported Event|Group 1|All participants recieved Interpersonal psychotherapy
650821|NCT00400946|B6|Baseline|Total|Total of all reporting groups
650822|NCT00400946|B5|Baseline|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
650823|NCT00400946|B4|Baseline|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
650824|NCT00400946|B3|Baseline|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
650860|NCT00400881|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
650861|NCT00400881|O2|Outcome|ATC (AT Comp)|Automatic Tube Compensation
650862|NCT00400881|O1|Outcome|CPAP|Continuous Positive Airway Pressure
650825|NCT00400946|B2|Baseline|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650826|NCT00400946|B1|Baseline|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650827|NCT00400946|P5|Participant Flow|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
650828|NCT00400946|P4|Participant Flow|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
650829|NCT00400946|P3|Participant Flow|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
650830|NCT00400946|P2|Participant Flow|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650831|NCT00400946|P1|Participant Flow|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650832|NCT00400946|O5|Outcome|Traumatic Tap Without Blasts|Traumatic Tap without Blasts: without blast cells and >100 RBCs on a wet prep
650833|NCT00400946|O4|Outcome|Traumatic Tap With Blasts|Traumatic Tap with Blasts: with blast cells and >100 RBCs on a wet prep
650834|NCT00400946|O3|Outcome|CNS-3|CNS-3: more than 5 WBC on CSF cell count, with blasts on cytospin
650835|NCT00400946|O2|Outcome|CNS-2|CNS-2: 5 or fewer WBC on CSF cell count, with blasts on cytospin
650836|NCT00400946|O1|Outcome|CNS-1|CNS-1: no blast cells in cytospin, regardless of cerebrospinal fluid (CSF) count
650837|NCT00400946|O3|Outcome|Hypocellular Day 18 Bone Marrow Status|Hypocellular marrow morphology at day 18 was defined as empty blasts.
650838|NCT00400946|O2|Outcome|M2/M3 Day 18 Bone Marrow Status|M2 marrow morphology at day 18 was defined as 5-24% blasts. M3 marrow morphology at day 18 was defined as >25% blasts.
650839|NCT00400946|O1|Outcome|M1 Day 18 Bone Marrow Status|M1 marrow morphology at day 18 was defined as <5% blasts.
650840|NCT00400946|O2|Outcome|High Day 32 MRD Level|High end-induction (day 32) minimal residual disease (MRD) evaluated was defined as >/=0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods
650841|NCT00400946|O1|Outcome|Low Day 32 MRD Level|Low end-induction (day 32) minimal residual disease (MRD) evaluated was defined as <0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods.
650842|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
650843|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
650863|NCT00400881|O2|Outcome|ATC (ATComp)|Automatic Tube Compensation
650864|NCT00400881|O1|Outcome|CPAP|Continuous Positive Airway Pressure
652282|NCT00396877|E1|Reported Event|Placebo|
650844|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
650845|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650846|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650847|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650848|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650849|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650850|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650851|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650852|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650853|NCT00400946|E3|Reported Event|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
650854|NCT00400946|E2|Reported Event|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650855|NCT00400946|E1|Reported Event|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
650856|NCT00400881|B3|Baseline|Total|Total of all reporting groups
650857|NCT00400881|B2|Baseline|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
650858|NCT00400881|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
650866|NCT00400881|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
650867|NCT00400829|B1|Baseline|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
650868|NCT00400829|P1|Participant Flow|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
650869|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
650870|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
650871|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
650872|NCT00400829|E1|Reported Event|Arm I|"Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
650873|NCT00400803|B1|Baseline|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
650874|NCT00400803|P1|Participant Flow|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
650875|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
650876|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
650877|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
650878|NCT00400803|O4|Outcome|Progressive Disease|At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
650879|NCT00400803|O3|Outcome|Stable Disease|Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.
650880|NCT00400803|O2|Outcome|Partial Response|At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
650881|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine, Carboplatin and Avastin IV every 14 days.
650882|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
650883|NCT00400803|E1|Reported Event|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
650884|NCT00400764|B6|Baseline|Total|Total of all reporting groups
650885|NCT00400764|B5|Baseline|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650886|NCT00400764|B4|Baseline|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650887|NCT00400764|B3|Baseline|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
653959|NCT00394589|E2|Reported Event|Infliximab*3mg/kg Q6W|
650888|NCT00400764|B2|Baseline|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650889|NCT00400764|B1|Baseline|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650890|NCT00400764|P5|Participant Flow|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650891|NCT00400764|P4|Participant Flow|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650892|NCT00400764|P3|Participant Flow|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650893|NCT00400764|P2|Participant Flow|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650894|NCT00400764|P1|Participant Flow|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650895|NCT00400764|O2|Outcome|Phase II Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants may also have received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650896|NCT00400764|O1|Outcome|Phase Ib Dulanermin|Participants received 4.0 mg/kg/day or 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650897|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650898|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650899|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650900|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650901|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650902|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650903|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650904|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650905|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650906|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650907|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650908|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650909|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650910|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650911|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650912|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650913|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650914|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650915|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650916|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650917|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650918|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650919|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650920|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650921|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650922|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650923|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650924|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650925|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650926|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650927|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650928|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650929|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650930|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650931|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650932|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650933|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650934|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650935|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650936|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650937|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650938|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650939|NCT00400764|E5|Reported Event|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
650940|NCT00400764|E4|Reported Event|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650941|NCT00400764|E3|Reported Event|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
650942|NCT00400764|E2|Reported Event|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650943|NCT00400764|E1|Reported Event|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
650944|NCT00400712|B3|Baseline|Total|Total of all reporting groups
650945|NCT00400712|B2|Baseline|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650946|NCT00400712|B1|Baseline|Control|natural progression post-stroke
650947|NCT00400712|P2|Participant Flow|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)
650948|NCT00400712|P1|Participant Flow|Control|no intervention, natural history following stroke
650949|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650950|NCT00400712|O1|Outcome|Control|natural progression post-stroke
650951|NCT00400712|O2|Outcome|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months .
650952|NCT00400712|O1|Outcome|Control|no intervention, natural progression post-stroke
650953|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650954|NCT00400712|O1|Outcome|Control|natural progression post-stroke
650955|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650956|NCT00400712|O1|Outcome|Control|natural progression post-stroke
650957|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650958|NCT00400712|O1|Outcome|Control|natural progression post-stroke
650959|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650960|NCT00400712|O1|Outcome|Control|natural progression post-stroke
650961|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650962|NCT00400712|O1|Outcome|Control|natural progression post-stroke
650963|NCT00400712|E2|Reported Event|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
650964|NCT00400712|E1|Reported Event|Control|natural progression post-stroke
650965|NCT00400686|B1|Baseline|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
650966|NCT00400686|P1|Participant Flow|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
650967|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
650968|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
650969|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
650970|NCT00400686|E1|Reported Event|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
650971|NCT00400634|B3|Baseline|Total|Total of all reporting groups
650972|NCT00400634|B2|Baseline|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
650973|NCT00400634|B1|Baseline|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
650974|NCT00400634|P2|Participant Flow|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
650975|NCT00400634|P1|Participant Flow|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
650977|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
650978|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
650979|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
650980|NCT00400634|E2|Reported Event|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
650981|NCT00400634|E1|Reported Event|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
650982|NCT00400569|B1|Baseline|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
650983|NCT00400569|P1|Participant Flow|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
650984|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
650985|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
650986|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
650987|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
650988|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
650989|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
650990|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
650991|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
650992|NCT00400569|E1|Reported Event|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
650993|NCT00400400|B3|Baseline|Total|Total of all reporting groups
650994|NCT00400400|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
650995|NCT00400400|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
650996|NCT00400400|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
650997|NCT00400400|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
650998|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
650999|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651000|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651001|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651002|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651020|NCT00400179|B2|Baseline|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651045|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651003|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651004|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651005|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651006|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651007|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651008|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651009|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651010|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651011|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651012|NCT00400400|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651013|NCT00400400|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
651014|NCT00400205|B1|Baseline|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
651015|NCT00400205|P1|Participant Flow|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
651016|NCT00400205|O1|Outcome|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
651017|NCT00400205|O1|Outcome|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
651018|NCT00400205|E1|Reported Event|Recipients of Docetaxel, Cisplatin, 5-Fluorouracil|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
651019|NCT00400179|B3|Baseline|Total|Total of all reporting groups
651042|NCT00400153|P1|Participant Flow|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651021|NCT00400179|B1|Baseline|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651022|NCT00400179|P2|Participant Flow|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651023|NCT00400179|P1|Participant Flow|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651024|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651025|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651026|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651027|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651028|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651029|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651030|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651031|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651032|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651033|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651034|NCT00400179|E2|Reported Event|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
651035|NCT00400179|E1|Reported Event|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
651036|NCT00400153|B4|Baseline|Total|Total of all reporting groups
651037|NCT00400153|B3|Baseline|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651038|NCT00400153|B2|Baseline|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651039|NCT00400153|B1|Baseline|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651040|NCT00400153|P3|Participant Flow|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651041|NCT00400153|P2|Participant Flow|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651046|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651047|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651048|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651049|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651050|NCT00400153|O3|Outcome|Ipratropium Respimat 20 Mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651051|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651052|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651053|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651054|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651055|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651056|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651057|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651058|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to rating of turning
651059|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to device preference
651060|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651061|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651062|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651063|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651064|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651065|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651066|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651067|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651068|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651069|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651070|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651071|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651072|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651073|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651074|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651075|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651076|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651077|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651078|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651079|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651080|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
651081|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
651082|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651083|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651084|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651085|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651086|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651087|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651088|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651089|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651090|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651091|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651092|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651093|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651094|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651095|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651096|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651097|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651098|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651099|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651100|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651101|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651102|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651103|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651104|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651105|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651106|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651107|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651108|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651109|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651110|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651111|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651112|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651113|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651114|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651115|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651116|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651117|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651118|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651119|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651120|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651121|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651122|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651123|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651124|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651125|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651126|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651127|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651128|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651129|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651130|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651131|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651132|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651133|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651134|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651135|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651136|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651137|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651138|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651139|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651140|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651141|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651142|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651143|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651144|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651145|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651146|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651147|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651148|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651149|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651150|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651151|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651152|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651153|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651154|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651155|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651156|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651157|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651158|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651159|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651160|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651161|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651162|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651163|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651164|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651165|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651166|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651167|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651168|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651169|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651170|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651171|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651172|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651173|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651174|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651175|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651176|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651177|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651178|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651179|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651180|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651181|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651182|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651183|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651184|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651185|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651186|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651187|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651188|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651189|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651190|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651191|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651192|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651193|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651194|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651195|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651196|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651197|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651198|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651199|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651200|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651201|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651202|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651203|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651204|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651205|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651206|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651207|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651208|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651209|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651210|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651211|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651212|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651213|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651214|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651215|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651216|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651217|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651218|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651219|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651220|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651221|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651222|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651223|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651224|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651225|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651226|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651227|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651228|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651229|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651230|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651231|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651232|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651233|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651234|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651235|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651236|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651237|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651238|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651239|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651240|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651241|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651242|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651243|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651244|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651245|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651246|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651247|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651248|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651249|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651250|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651251|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651252|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651253|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651254|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651255|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651256|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651257|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651258|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651259|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651260|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651261|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651262|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651263|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651264|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651265|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651266|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651267|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651268|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651269|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651270|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651271|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651272|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651273|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651274|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651275|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651276|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651277|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651278|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651279|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651280|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651281|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651282|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651283|NCT00400153|E3|Reported Event|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
651284|NCT00400153|E2|Reported Event|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
651285|NCT00400153|E1|Reported Event|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
651286|NCT00399893|B3|Baseline|Total|Total of all reporting groups
651287|NCT00399893|B2|Baseline|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651288|NCT00399893|B1|Baseline|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651289|NCT00399893|P2|Participant Flow|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651290|NCT00399893|P1|Participant Flow|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651291|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651292|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651293|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651294|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651295|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651296|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651297|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651298|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651299|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651300|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651301|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651302|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651303|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651304|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651305|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651306|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651307|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651308|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651309|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651310|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651311|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651312|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651313|NCT00399893|E2|Reported Event|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
651314|NCT00399893|E1|Reported Event|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
651315|NCT00399880|B3|Baseline|Total|Total of all reporting groups
651316|NCT00399880|B2|Baseline|Usual Care|Usual care arm
651317|NCT00399880|B1|Baseline|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
651318|NCT00399880|P2|Participant Flow|Usual Care|Usual care arm
651319|NCT00399880|P1|Participant Flow|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
651320|NCT00399880|O2|Outcome|Usual Care|Usual care arm
651321|NCT00399880|O1|Outcome|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
651322|NCT00399880|O2|Outcome|Usual Care|Usual care arm
651323|NCT00399880|O1|Outcome|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
651324|NCT00399880|E2|Reported Event|Usual Care|Usual care (Standard)
651325|NCT00399880|E1|Reported Event|Health Literacy Intervention|"Illustrated medication schedules, pill boxes, pharmacist counseling~Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling"
651326|NCT00399802|B3|Baseline|Total|Total of all reporting groups
651327|NCT00399802|B2|Baseline|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
651328|NCT00399802|B1|Baseline|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
651329|NCT00399802|P2|Participant Flow|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
651330|NCT00399802|P1|Participant Flow|Single Intravenous (IV) Infusion of Zoledronic Acid (ZA) 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
651331|NCT00399802|O2|Outcome|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
651332|NCT00399802|O1|Outcome|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
651333|NCT00399802|O2|Outcome|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
651334|NCT00399802|O1|Outcome|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
651335|NCT00399802|O2|Outcome|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
651336|NCT00399802|O1|Outcome|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
651337|NCT00399802|O2|Outcome|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
651338|NCT00399802|O1|Outcome|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
651339|NCT00399802|E2|Reported Event|Once-daily Odanacatib 5 mg|Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
651340|NCT00399802|E1|Reported Event|Single IV Infusion of ZA 4 mg|Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
651341|NCT00399763|B3|Baseline|Total|Total of all reporting groups
651342|NCT00399763|B2|Baseline|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
651343|NCT00399763|B1|Baseline|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
651344|NCT00399763|P2|Participant Flow|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
651345|NCT00399763|P1|Participant Flow|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
651346|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
651347|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
651348|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
651349|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
651350|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
651351|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
651352|NCT00399763|E2|Reported Event|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
651353|NCT00399763|E1|Reported Event|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
651354|NCT00399568|B3|Baseline|Total|Total of all reporting groups
651355|NCT00399568|B2|Baseline|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
651356|NCT00399568|B1|Baseline|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
651357|NCT00399568|P2|Participant Flow|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
651358|NCT00399568|P1|Participant Flow|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
651359|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
651360|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
651361|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
651362|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
651363|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|Safety Population(defined as those subjects who received any portion of a dose of IV Placebo 100 ml solution)
651364|NCT00399568|O1|Outcome|IV Acetaminophen 1g/100 ml Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 ml solution)
651365|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
651366|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
651367|NCT00399568|E2|Reported Event|IV Placebo 100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV Placebo 100 mL solution)
651368|NCT00399568|E1|Reported Event|IV Acetaminophen 1g/100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 mL solution)
651369|NCT00399542|B3|Baseline|Total|Total of all reporting groups
651370|NCT00399542|B2|Baseline|Placebo|Subjects who received placebo
651371|NCT00399542|B1|Baseline|Lubiprostone|Subjects who received active drug
651372|NCT00399542|P2|Participant Flow|Placebo|Subjects who received placebo
651373|NCT00399542|P1|Participant Flow|Lubiprostone|Subjects who received active drug
651374|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651375|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651376|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651377|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651378|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651379|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651380|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651381|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651382|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651383|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651384|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651385|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651386|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651387|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651388|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651389|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651390|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651391|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651392|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651393|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651394|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651395|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651396|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651397|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651398|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651399|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651400|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651401|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651402|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651403|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651404|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651405|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651406|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651407|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651408|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651409|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651410|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651411|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651412|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651413|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651414|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651415|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651416|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651417|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651418|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651419|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651420|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651421|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651422|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651423|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651424|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651425|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651426|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651427|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651428|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651429|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651430|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
651431|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
651432|NCT00399542|E2|Reported Event|Placebo|Subjects who received placebo
651433|NCT00399542|E1|Reported Event|Lubiprostone|Subjects who received active drug
651434|NCT00399516|B1|Baseline|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
651435|NCT00399516|P1|Participant Flow|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
651436|NCT00399516|O1|Outcome|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
651437|NCT00399516|E1|Reported Event|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
651439|NCT00399360|B4|Baseline|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651440|NCT00399360|B3|Baseline|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651441|NCT00399360|B2|Baseline|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651442|NCT00399360|B1|Baseline|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651443|NCT00399360|P4|Participant Flow|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651444|NCT00399360|P3|Participant Flow|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651445|NCT00399360|P2|Participant Flow|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651446|NCT00399360|P1|Participant Flow|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651447|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
651448|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
651449|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
651450|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
651451|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651452|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651453|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651454|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651455|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
651456|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
651457|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
651458|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
651459|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
651460|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
651461|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
651462|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
651463|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
651464|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
651465|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
651466|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|
651467|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
651468|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
651469|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
651470|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
651471|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
651472|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
651473|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
651474|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
651475|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651678|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
651476|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651477|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651478|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651479|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651480|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651481|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651482|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651483|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651484|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651485|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651486|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651487|NCT00399360|E4|Reported Event|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651488|NCT00399360|E3|Reported Event|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651489|NCT00399360|E2|Reported Event|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651490|NCT00399360|E1|Reported Event|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
651491|NCT00399308|B4|Baseline|Total|Total of all reporting groups
651492|NCT00399308|B3|Baseline|Group III - Control|Adaptic and Profore four-layer compression dressing
651493|NCT00399308|B2|Baseline|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651494|NCT00399308|B1|Baseline|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651495|NCT00399308|P3|Participant Flow|Group III - Control|Adaptic and Profore four-layer compression dressing
651496|NCT00399308|P2|Participant Flow|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651497|NCT00399308|P1|Participant Flow|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651498|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
651499|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651500|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651501|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
651502|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651503|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651504|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
651505|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651679|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
651506|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651507|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
651508|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651509|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651510|NCT00399308|E3|Reported Event|Group III - Control|Adaptic and Profore four-layer compression dressing
651511|NCT00399308|E2|Reported Event|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651512|NCT00399308|E1|Reported Event|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
651513|NCT00399035|B4|Baseline|Total|Total of all reporting groups
651514|NCT00399035|B3|Baseline|Cediranib 30 mg|Cediranib 30 mg/day + FOLFOX/XELOX
651515|NCT00399035|B2|Baseline|Placebo|Placebo + FOLFOX/XELOX
651516|NCT00399035|B1|Baseline|Cediranib 20 mg|Cediranib 20 mg + FOLFOX/XELOX
651517|NCT00399035|P3|Participant Flow|Placebo|[Placebo +FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
651518|NCT00399035|P2|Participant Flow|Cediranib 30 mg/Day|[Cediranib 30mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
651519|NCT00399035|P1|Participant Flow|Cediranib 20 mg/Day|[Cediranib 20mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
651520|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
651521|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
651522|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
651523|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
651524|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
651525|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
651526|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
651527|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
651528|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
651529|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
651530|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
651531|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
651532|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
651533|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
651534|NCT00399035|E3|Reported Event|Placebo|Placebo + Folfox/Xelox
651535|NCT00399035|E2|Reported Event|Cediranib 20mg|Cediranib 20mg/day + Folfox/Xelox
651536|NCT00399035|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/day + Folfox/Xelox
651537|NCT00398983|B3|Baseline|Total|Total of all reporting groups
651538|NCT00398983|B2|Baseline|No Study Drug|Continue current therapy.
651539|NCT00398983|B1|Baseline|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
651540|NCT00398983|P2|Participant Flow|No Study Drug|Continue current therapy.
651541|NCT00398983|P1|Participant Flow|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
651542|NCT00398983|O2|Outcome|No Study Drug|Continue current therapy.
651543|NCT00398983|O1|Outcome|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
651544|NCT00398983|E2|Reported Event|No Study Drug|Continue current therapy.
651545|NCT00398983|E1|Reported Event|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
651546|NCT00398918|B1|Baseline|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
651547|NCT00398918|P1|Participant Flow|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
651548|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
651549|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
651550|NCT00398918|E1|Reported Event|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
651551|NCT00398866|B4|Baseline|Total|Total of all reporting groups
651552|NCT00398866|B3|Baseline|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
651553|NCT00398866|B2|Baseline|Triamcinolone|"Corticosteroid (trimcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
651554|NCT00398866|B1|Baseline|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
651555|NCT00398866|P3|Participant Flow|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
651556|NCT00398866|P2|Participant Flow|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
651557|NCT00398866|P1|Participant Flow|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
651558|NCT00398866|O3|Outcome|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
651559|NCT00398866|O2|Outcome|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
651560|NCT00398866|O1|Outcome|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
651561|NCT00398866|O3|Outcome|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
651562|NCT00398866|O2|Outcome|Triamcinolone|"Corticosteroid (trimcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
651563|NCT00398866|O1|Outcome|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
651564|NCT00398866|E3|Reported Event|Hylan G-F 20|"Synvisc~Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks"
651565|NCT00398866|E2|Reported Event|Triamcinolone|"Corticosteroid (triamcinolone (Kenalog) 40 mg)~Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation"
651566|NCT00398866|E1|Reported Event|Bupivicaine|"Bupivicaine (local anesthetic)~Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks"
651567|NCT00398632|B1|Baseline|Duloxetine|Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
651568|NCT00398632|P1|Participant Flow|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
651569|NCT00398632|O1|Outcome|Duloxetine|Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
651570|NCT00398632|O1|Outcome|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
651571|NCT00398632|E1|Reported Event|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
651572|NCT00398567|B4|Baseline|Total|Total of all reporting groups
651573|NCT00398567|B3|Baseline|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651574|NCT00398567|B2|Baseline|Neratinib 240 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651575|NCT00398567|B1|Baseline|Neratinib 160 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651576|NCT00398567|P3|Participant Flow|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651577|NCT00398567|P2|Participant Flow|Neratinib 240mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651578|NCT00398567|P1|Participant Flow|Neratinib 160mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651579|NCT00398567|O1|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651580|NCT00398567|O1|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651581|NCT00398567|O1|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651582|NCT00398567|O1|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651583|NCT00398567|O1|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651584|NCT00398567|O1|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651585|NCT00398567|O1|Outcome|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651586|NCT00398567|E3|Reported Event|Part 2 - Expanded MTD Cohort|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651587|NCT00398567|E2|Reported Event|Neratinib 240 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651588|NCT00398567|E1|Reported Event|Neratinib 160 mg + Trastuzumab|All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 160 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter
651589|NCT00398476|B1|Baseline|Overall Study Arm|Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril – 4 sprays in total). Sequence of either FP 200 µg/FF 110 µg or FF 110 µg/FP 200 µgin a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
651590|NCT00398476|P2|Participant Flow|FP 200 µg /FF 110 µg|In this sequence, participants received a single-dose treatment FP 200 µg in period 1 and FF 110 µg in period 2 (2 sprays per nostril – 4 sprays in total) for 30 minutes. Each spray of the suspension was containing approximately 27.5 µg of FF and Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter. There was a washout period of 20 minutes in between the 2 periods.
651591|NCT00398476|P1|Participant Flow|FF 110 µg /FP 200 µg|In this sequence, participants received a single-dose treatment fluticasone furoate (FF) 110 micrograms (µg) in period 1 and fluticasone propionate (FP) 200 µg in period 2 (2 sprays per nostril – 4 sprays in total) for 30 minutes. Each spray of the suspension was containing approximately 27.5 µg of FF and each actuation delivered 50 µg of FP in 100 milligram (mg) of formulation through the nasal adapter. There was a washout period of 20 minutes in between the 2 periods.
651592|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651593|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651594|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651595|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651680|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
651681|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
651596|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651597|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651598|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651599|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651600|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study
651601|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651602|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651603|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651604|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651605|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651606|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651607|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651608|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651609|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651610|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651611|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651612|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651613|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651614|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651615|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651616|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651617|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651618|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651619|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651620|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651621|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651622|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651623|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651624|NCT00398476|O2|Outcome|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651625|NCT00398476|O1|Outcome|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651626|NCT00398476|O1|Outcome|Overall Study Arm|Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril – 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
651627|NCT00398476|E2|Reported Event|FP 200 µg|Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651682|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
651683|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
651684|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
651628|NCT00398476|E1|Reported Event|FF 110 µg|Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril – 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
651629|NCT00398411|B3|Baseline|Total|Total of all reporting groups
651630|NCT00398411|B2|Baseline|Placebo|identical appearing placebo
651631|NCT00398411|B1|Baseline|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651632|NCT00398411|P2|Participant Flow|Placebo|identical appearing placebo
651633|NCT00398411|P1|Participant Flow|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651634|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
651635|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651636|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
651637|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651638|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
651639|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651640|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
651641|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651642|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
651643|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651644|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
651645|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651646|NCT00398411|E2|Reported Event|Placebo|identical appearing placebo
651647|NCT00398411|E1|Reported Event|Moxifloxacin|moxifloxacin 400 mg tablets once daily
651648|NCT00398398|B1|Baseline|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
651649|NCT00398398|P1|Participant Flow|Xelox Plus Cetuximab|"Capecitabine, oxaliplatin and cetuximab~cetuximab : initial loading dose of 400 mg/m2, maintenance dose of 250 mg/m2 (every week) Oxaliplatin : 130 mg/m2 (every 3 weeks) capecitabine :1,000 mg/m2 (days 1–14)"
651650|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
651651|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
651652|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
651653|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
651654|NCT00398398|E1|Reported Event|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
651655|NCT00398320|B1|Baseline|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
651656|NCT00398320|P1|Participant Flow|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~Adverse events (AEs) reported are related and grade 3 or higher per CTCAE version 3."
651657|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
651658|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
651659|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
651660|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
651661|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
651662|NCT00398320|E1|Reported Event|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
651663|NCT00398216|B6|Baseline|Total|Total of all reporting groups
651664|NCT00398216|B5|Baseline|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
651665|NCT00398216|B4|Baseline|Edoxaban 90mg QD|edoxaban 90mg QD PO
651666|NCT00398216|B3|Baseline|Edoxaban 60mg QD|edoxaban 60mg QD PO
651667|NCT00398216|B2|Baseline|Edoxaban 30mg QD|edoxaban 30mg QD PO
651668|NCT00398216|B1|Baseline|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
651669|NCT00398216|P5|Participant Flow|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
651670|NCT00398216|P4|Participant Flow|Edoxaban 90mg QD|edoxaban 90mg QD PO
651671|NCT00398216|P3|Participant Flow|Edoxaban 60mg QD|edoxaban 60mg QD PO
651672|NCT00398216|P2|Participant Flow|Edoxaban 30mg QD|edoxaban 30mg QD PO
651673|NCT00398216|P1|Participant Flow|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
651674|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
651675|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
651676|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
651688|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
651689|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
651690|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
651691|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
651692|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
651693|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
651694|NCT00398216|E5|Reported Event|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
651695|NCT00398216|E4|Reported Event|Edoxaban 90mg QD|edoxaban 90mg QD PO
651696|NCT00398216|E3|Reported Event|Edoxaban 60mg QD|edoxaban 60mg QD PO
651697|NCT00398216|E2|Reported Event|Edoxaban 30mg QD|edoxaban 30mg QD PO
651698|NCT00398216|E1|Reported Event|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
651699|NCT00398138|B1|Baseline|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
651700|NCT00398138|P1|Participant Flow|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
651701|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
651702|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
651703|NCT00398138|E1|Reported Event|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
651704|NCT00398112|B1|Baseline|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651705|NCT00398112|P1|Participant Flow|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651706|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651707|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651708|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651709|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651710|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651711|NCT00398112|E1|Reported Event|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
651712|NCT00398086|B4|Baseline|Total|Total of all reporting groups
651713|NCT00398086|B3|Baseline|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651714|NCT00398086|B2|Baseline|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651715|NCT00398086|B1|Baseline|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651716|NCT00398086|P3|Participant Flow|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651717|NCT00398086|P2|Participant Flow|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651718|NCT00398086|P1|Participant Flow|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651719|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651720|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651721|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651722|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651723|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651724|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651725|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651726|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651727|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651728|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651729|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651730|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651731|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651732|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651733|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651734|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651805|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651735|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651736|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651737|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651738|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651739|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651740|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651741|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651742|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651743|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651744|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651745|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651746|NCT00398086|E3|Reported Event|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
651747|NCT00398086|E2|Reported Event|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
651748|NCT00398086|E1|Reported Event|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
651749|NCT00398073|B3|Baseline|Total|Total of all reporting groups
651750|NCT00398073|B2|Baseline|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
651751|NCT00398073|B1|Baseline|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
651752|NCT00398073|P2|Participant Flow|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
651753|NCT00398073|P1|Participant Flow|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
651754|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
651755|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
651756|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
651806|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651807|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651757|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
651758|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
651759|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
651760|NCT00398073|E2|Reported Event|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
651761|NCT00398073|E1|Reported Event|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
651762|NCT00398047|B1|Baseline|Azacitidine and Darbopoietin and G-CSF|
651763|NCT00398047|P1|Participant Flow|Combination of Azacitadine and Hematopoietic Growth Factors|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
651764|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
651765|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
651766|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
651767|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
651768|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
651769|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
651770|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
651771|NCT00398047|E1|Reported Event|Azacitidine and Darbopoietin and G-CSF|
651772|NCT00397982|B1|Baseline|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
651773|NCT00397982|P1|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody)|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
651774|NCT00397982|O1|Outcome|Entire Study|17 participants
651775|NCT00397982|O1|Outcome|Entire Study|17 participants
651776|NCT00397982|O1|Outcome|Entire Study|17 participants
651777|NCT00397982|O1|Outcome|Entire Study|17 participants
651778|NCT00397982|O1|Outcome|Entire Study|17 participants
651779|NCT00397982|O1|Outcome|Entire Study|Treatment
651780|NCT00397982|E1|Reported Event|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
651781|NCT00397930|B3|Baseline|Total|Total of all reporting groups
651782|NCT00397930|B2|Baseline|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
652151|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
651783|NCT00397930|B1|Baseline|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
651784|NCT00397930|P2|Participant Flow|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
651785|NCT00397930|P1|Participant Flow|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
651786|NCT00397930|O2|Outcome|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
651787|NCT00397930|O1|Outcome|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
651788|NCT00397930|E2|Reported Event|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
651789|NCT00397930|E1|Reported Event|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
651790|NCT00397904|B1|Baseline|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
651791|NCT00397904|P1|Participant Flow|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
651792|NCT00397904|O1|Outcome|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
651793|NCT00397904|E1|Reported Event|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
651794|NCT00397891|B6|Baseline|Total|Total of all reporting groups
651795|NCT00397891|B5|Baseline|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651796|NCT00397891|B4|Baseline|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651797|NCT00397891|B3|Baseline|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651798|NCT00397891|B2|Baseline|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651799|NCT00397891|B1|Baseline|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651800|NCT00397891|P5|Participant Flow|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651801|NCT00397891|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651802|NCT00397891|P3|Participant Flow|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651803|NCT00397891|P2|Participant Flow|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651804|NCT00397891|P1|Participant Flow|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651808|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651809|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651810|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651811|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651812|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651813|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651814|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651815|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651816|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651817|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651818|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651819|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651820|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651821|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651822|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651823|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651824|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651825|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651826|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651827|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651828|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651829|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651830|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651831|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651832|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651833|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651834|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651835|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651836|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651837|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651838|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651839|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651840|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651841|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651842|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651843|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651844|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651845|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651846|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651847|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651848|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651849|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651850|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651851|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651852|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651853|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651854|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
652152|NCT00397150|O2|Outcome|No Intervention|Standard of care
651855|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651856|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651857|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651858|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651859|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651860|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651861|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651862|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651863|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651864|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651865|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651866|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651867|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651868|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651869|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651870|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651871|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651872|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651873|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651874|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651875|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651876|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651877|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651878|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651879|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651880|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651881|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651882|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651883|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651884|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651885|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651886|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651887|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651888|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651889|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651890|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651891|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651892|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651893|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651894|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651895|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651896|NCT00397891|E5|Reported Event|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
651897|NCT00397891|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
651898|NCT00397891|E3|Reported Event|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
651899|NCT00397891|E2|Reported Event|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
651900|NCT00397891|E1|Reported Event|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
651901|NCT00397878|B1|Baseline|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
653960|NCT00394589|E1|Reported Event|Infliximab*3mg/kg+1*Vial Q8W|
651902|NCT00397878|P1|Participant Flow|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
651903|NCT00397878|O1|Outcome|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
651904|NCT00397878|E1|Reported Event|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
651905|NCT00397839|B3|Baseline|Total|Total of all reporting groups
651906|NCT00397839|B2|Baseline|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651907|NCT00397839|B1|Baseline|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651908|NCT00397839|P2|Participant Flow|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651909|NCT00397839|P1|Participant Flow|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651910|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651911|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651912|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651913|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651914|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651915|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651916|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651917|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651918|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651919|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651920|NCT00397839|E2|Reported Event|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
651921|NCT00397839|E1|Reported Event|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
651922|NCT00397631|B3|Baseline|Total|Total of all reporting groups
651923|NCT00397631|B2|Baseline|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
651924|NCT00397631|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
651925|NCT00397631|P2|Participant Flow|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
651926|NCT00397631|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
651927|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
651928|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
651929|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
651930|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
651931|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
651932|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
651933|NCT00397631|E2|Reported Event|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
651934|NCT00397631|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
651935|NCT00397540|B3|Baseline|Total|Total of all reporting groups
651936|NCT00397540|B2|Baseline|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
651937|NCT00397540|B1|Baseline|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
651938|NCT00397540|P2|Participant Flow|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
653961|NCT00394524|B3|Baseline|Total|Total of all reporting groups
651939|NCT00397540|P1|Participant Flow|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
651940|NCT00397540|O2|Outcome|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
651941|NCT00397540|O1|Outcome|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
651942|NCT00397540|E2|Reported Event|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
651943|NCT00397540|E1|Reported Event|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
651944|NCT00397514|B1|Baseline|Congenital Heart Disease Patients|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
651945|NCT00397514|P1|Participant Flow|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
651946|NCT00397514|O1|Outcome|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
651947|NCT00397514|O3|Outcome|RV Pacing|QRS duration when patient's extubation with 20 min. of right ventricular pacing
651948|NCT00397514|O2|Outcome|BiV Pacing|QRS duration when patient's extubation with 20 min. of biventricular pacing
651949|NCT00397514|O1|Outcome|Baseline|QRS duration at baseline
651950|NCT00397514|O3|Outcome|RV Pacing|Cardiac Index when patient's extubation with 20 min. of right ventricular pacing
651951|NCT00397514|O2|Outcome|BiV Pacing|Cardiac Index when patient's extubation with 20 min. of biventricular pacing
651952|NCT00397514|O1|Outcome|Baseline|Cardiac Index at baseline.
651953|NCT00397514|E1|Reported Event|Pacing Protocol and RV Pacing|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
651954|NCT00397488|B1|Baseline|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
651955|NCT00397488|P1|Participant Flow|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
651956|NCT00397488|O1|Outcome|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
651957|NCT00397488|E1|Reported Event|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
651958|NCT00397462|B4|Baseline|Total|Total of all reporting groups
651959|NCT00397462|B3|Baseline|Control|No use of the intervention
651960|NCT00397462|B2|Baseline|Group 2 High Use|requested that they use the intervention as much as possible during the work day
651961|NCT00397462|B1|Baseline|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
651962|NCT00397462|P3|Participant Flow|Control|No intervention
651963|NCT00397462|P2|Participant Flow|Group 2 High Use|requested that they use the intervention as much as possible during the work day
651964|NCT00397462|P1|Participant Flow|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
651965|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
651966|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
651967|NCT00397462|O1|Outcome|Control|No change to usual behavior
651968|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
651969|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
651970|NCT00397462|O1|Outcome|Control|No change to usual behavior
651971|NCT00397462|E3|Reported Event|Control|did not use the intervention
651972|NCT00397462|E2|Reported Event|Group 2 High Use|requested that they use the intervention as much as possible during the work day
651973|NCT00397462|E1|Reported Event|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
651974|NCT00397254|B1|Baseline|Baseline Period - Rizatriptan 9 Tablets|Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.
651975|NCT00397254|P2|Participant Flow|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651976|NCT00397254|P1|Participant Flow|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651977|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
652153|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
652154|NCT00397150|O2|Outcome|No Intervention|Standard of care
651978|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651979|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651980|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651981|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651982|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651983|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651984|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651985|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651986|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651987|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651988|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651989|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651990|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651991|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
651992|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
651993|NCT00397215|B5|Baseline|Total|Total of all reporting groups
651994|NCT00397215|B4|Baseline|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
651995|NCT00397215|B3|Baseline|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
651996|NCT00397215|B2|Baseline|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
651997|NCT00397215|B1|Baseline|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
651998|NCT00397215|P4|Participant Flow|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
651999|NCT00397215|P3|Participant Flow|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652000|NCT00397215|P2|Participant Flow|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652001|NCT00397215|P1|Participant Flow|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652002|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652003|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652004|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652005|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652006|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652007|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652008|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652009|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652010|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652011|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652012|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652013|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652014|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652015|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652016|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652017|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652018|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652019|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652020|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652021|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652022|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652023|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652024|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652025|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652026|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652027|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652028|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652029|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652030|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652155|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
652156|NCT00397150|O2|Outcome|No Intervention|Standard of care
652031|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652032|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652033|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652034|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652035|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652036|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652037|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652038|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652039|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652040|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652041|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652042|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652043|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652044|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652045|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652046|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652047|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652048|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652049|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652050|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652051|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652052|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652053|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652054|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652055|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652056|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652057|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652058|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652059|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652060|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652061|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652062|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652063|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652064|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652065|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652066|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652067|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652068|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652069|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652070|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652071|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652072|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652073|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652074|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652075|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652076|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652077|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652078|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652079|NCT00397215|O3|Outcome|GSK1562902A 3 Group|GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652080|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652081|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652082|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652083|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652084|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652085|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652157|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
652158|NCT00397150|E2|Reported Event|Standard of Care|
652086|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652087|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652088|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652089|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652090|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652091|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652092|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652093|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652094|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652095|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652096|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652097|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652098|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652099|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652100|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652101|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652102|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652103|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652104|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652105|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652106|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652107|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652108|NCT00397215|O2|Outcome|GSK1562902A 2 Group|GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652109|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652110|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652111|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652112|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652113|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652114|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652115|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652116|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652117|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652118|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652119|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652120|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652121|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652122|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652123|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652124|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652125|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652126|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652127|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652128|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652129|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652130|NCT00397215|E4|Reported Event|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652131|NCT00397215|E3|Reported Event|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
652132|NCT00397215|E2|Reported Event|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652133|NCT00397215|E1|Reported Event|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
652134|NCT00397189|B3|Baseline|Total|Total of all reporting groups
652135|NCT00397189|B2|Baseline|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
652136|NCT00397189|B1|Baseline|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
652137|NCT00397189|P2|Participant Flow|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
652138|NCT00397189|P1|Participant Flow|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
652139|NCT00397189|O2|Outcome|Placebo|placebo circadin: placebo circadin tablets
652140|NCT00397189|O1|Outcome|Circadin|Circadin: Prolonged release melatonin 2 mg
652141|NCT00397189|O2|Outcome|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
652142|NCT00397189|O1|Outcome|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
652143|NCT00397189|E2|Reported Event|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
652144|NCT00397189|E1|Reported Event|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
652145|NCT00397150|B3|Baseline|Total|Total of all reporting groups
652146|NCT00397150|B2|Baseline|No Intervention|Standard of care
652147|NCT00397150|B1|Baseline|Intervention|Peer-counselling for exclusive breastfeeding
652148|NCT00397150|P2|Participant Flow|No Intervention|Standard of care
652149|NCT00397150|P1|Participant Flow|Intervention|Peer-counselling for exclusive breastfeeding
652150|NCT00397150|O2|Outcome|No Intervention|Standard of care
652278|NCT00396877|O1|Outcome|Placebo|
652159|NCT00397150|E1|Reported Event|Peer Counselling for Exclusive Breastfeeding|
652160|NCT00397046|B5|Baseline|Total|Total of all reporting groups
652161|NCT00397046|B4|Baseline|Neratinib 320 mg|Neratinib 320 mg qd
652162|NCT00397046|B3|Baseline|Neratinib 240 mg|Neratinib 240 mg qd
652163|NCT00397046|B2|Baseline|Neratinib 160 mg|Neratinib 160 mg qd
652164|NCT00397046|B1|Baseline|Neratinib 80 mg|Neratinib 80 mg qd
652165|NCT00397046|P4|Participant Flow|Neratinib 320 mg|Neratinib 320 mg qd
652166|NCT00397046|P3|Participant Flow|Neratinib 240 mg|Neratinib 240 mg qd
652167|NCT00397046|P2|Participant Flow|Neratinib 160 mg|Neratinib 160 mg qd
652168|NCT00397046|P1|Participant Flow|Neratinib 80 mg|Neratinib 80 mg qd
652169|NCT00397046|O4|Outcome|Neratinib 320 mg|Neratinib 320 mg qd
652170|NCT00397046|O3|Outcome|Neratinib 240 mg|Neratinib 240 mg qd
652171|NCT00397046|O2|Outcome|Neratinib 160 mg|Neratinib 160 mg qd
652172|NCT00397046|O1|Outcome|Neratinib 80 mg|Neratinib 80 mg qd
652173|NCT00397046|O4|Outcome|Neratinib 320 mg|Neratinib 320 mg qd
652174|NCT00397046|O3|Outcome|Neratinib 240 mg|Neratinib 240 mg qd
652175|NCT00397046|O2|Outcome|Neratinib 160 mg|Neratinib 160 mg qd
652176|NCT00397046|O1|Outcome|Neratinib 80 mg|Neratinib 80 mg qd
652177|NCT00397046|O4|Outcome|Neratinib 320 mg|Neratinib 320 mg qd
652178|NCT00397046|O3|Outcome|Neratinib 240 mg|Neratinib 240 mg qd
652179|NCT00397046|O2|Outcome|Neratinib 160 mg|Neratinib 160 mg qd
652180|NCT00397046|O1|Outcome|Neratinib 80 mg|Neratinib 80 mg qd
652181|NCT00397046|E4|Reported Event|Neratinib 320 mg|Neratinib 320 mg qd
652182|NCT00397046|E3|Reported Event|Neratinib 240 mg|Neratinib 240 mg qd
652183|NCT00397046|E2|Reported Event|Neratinib 160 mg|Neratinib 160 mg qd
652184|NCT00397046|E1|Reported Event|Neratinib 80 mg|Neratinib 80 mg qd
652185|NCT00397033|B4|Baseline|Total|Total of all reporting groups
652186|NCT00397033|B3|Baseline|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652187|NCT00397033|B2|Baseline|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652188|NCT00397033|B1|Baseline|Placebo|
652189|NCT00397033|P3|Participant Flow|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652190|NCT00397033|P2|Participant Flow|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652191|NCT00397033|P1|Participant Flow|Placebo|
652192|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652193|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652194|NCT00397033|O1|Outcome|Placebo|
652195|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652196|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652197|NCT00397033|O1|Outcome|Placebo|
652198|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652199|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652200|NCT00397033|O1|Outcome|Placebo|
652201|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652202|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652203|NCT00397033|O1|Outcome|Placebo|
652204|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652205|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652206|NCT00397033|O1|Outcome|Placebo|
652207|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652208|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652209|NCT00397033|O1|Outcome|Placebo|
652210|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652211|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652212|NCT00397033|O1|Outcome|Placebo|
652213|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652214|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652215|NCT00397033|O1|Outcome|Placebo|
652216|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652217|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652218|NCT00397033|O1|Outcome|Placebo|
652219|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652220|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652221|NCT00397033|O1|Outcome|Placebo|
652279|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
652222|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652223|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652224|NCT00397033|O1|Outcome|Placebo|
652225|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652226|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652227|NCT00397033|O1|Outcome|Placebo|
652228|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652229|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652230|NCT00397033|O1|Outcome|Placebo|
652231|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652232|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652233|NCT00397033|O1|Outcome|Placebo|
652234|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652235|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652236|NCT00397033|O1|Outcome|Placebo|
652237|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652238|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652239|NCT00397033|O1|Outcome|Placebo|
652240|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652241|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652242|NCT00397033|O1|Outcome|Placebo|
652243|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652244|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652245|NCT00397033|O1|Outcome|Placebo|
652246|NCT00397033|E3|Reported Event|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
652247|NCT00397033|E2|Reported Event|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
652248|NCT00397033|E1|Reported Event|Placebo|
652249|NCT00396981|B3|Baseline|Total|Total of all reporting groups
652250|NCT00396981|B2|Baseline|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
652251|NCT00396981|B1|Baseline|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
652252|NCT00396981|P2|Participant Flow|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
652253|NCT00396981|P1|Participant Flow|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
652254|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652255|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652256|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652257|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652258|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652259|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652260|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652261|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652262|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652263|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652264|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652265|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652266|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652267|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652268|NCT00396981|E2|Reported Event|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
652269|NCT00396981|E1|Reported Event|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
652270|NCT00396877|B3|Baseline|Total|Total of all reporting groups
652271|NCT00396877|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|
652272|NCT00396877|B1|Baseline|Placebo|
652273|NCT00396877|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|"Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.~Route: oral or enteric~Frequency: once daily~Dose: daily dose adjusted for weight"
652274|NCT00396877|P1|Participant Flow|Placebo|Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
652275|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
652276|NCT00396877|O1|Outcome|Placebo|
652277|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
652283|NCT00396812|B1|Baseline|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652284|NCT00396812|P1|Participant Flow|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652285|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652286|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652287|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652288|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652289|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652290|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652291|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652292|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652293|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
652294|NCT00396812|E1|Reported Event|Rituximab|Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2. Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid.
652295|NCT00396656|B1|Baseline|Entire Study Population|Includes patients that received valsartan followed by atenolol + hydrochlorothiazide and patients that received atenolol + hydrochlorothiazide followed by valsartan.
652296|NCT00396656|P2|Participant Flow|Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan|"After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning"
652297|NCT00396656|P1|Participant Flow|Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)|"After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning."
652298|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
652299|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
652300|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
652301|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
652367|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652302|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
652303|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
652304|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
652305|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
652306|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
652307|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
652308|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
652309|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
652310|NCT00396656|E2|Reported Event|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
652311|NCT00396656|E1|Reported Event|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
652312|NCT00396630|B3|Baseline|Total|Total of all reporting groups
652313|NCT00396630|B2|Baseline|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652314|NCT00396630|B1|Baseline|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652315|NCT00396630|P2|Participant Flow|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652316|NCT00396630|P1|Participant Flow|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652317|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652318|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652319|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652320|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652321|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652322|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652323|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652324|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652368|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
652325|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652326|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652327|NCT00396630|O1|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652328|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652329|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652330|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652331|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652332|NCT00396630|O1|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652333|NCT00396630|E2|Reported Event|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652334|NCT00396630|E1|Reported Event|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
652335|NCT00396591|B1|Baseline|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652336|NCT00396591|P1|Participant Flow|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652337|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652338|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652339|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652340|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652341|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652342|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652343|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652344|NCT00396591|E1|Reported Event|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
652345|NCT00396565|B4|Baseline|Total|Total of all reporting groups
652346|NCT00396565|B3|Baseline|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652347|NCT00396565|B2|Baseline|Placebo|Two placebo tablets once daily for 6 weeks
652348|NCT00396565|B1|Baseline|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652349|NCT00396565|P3|Participant Flow|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652350|NCT00396565|P2|Participant Flow|Placebo|Two placebo tablets once daily for 6 weeks
652351|NCT00396565|P1|Participant Flow|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652352|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652353|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
652354|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652355|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652356|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
652357|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652358|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652359|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
652360|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652361|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652362|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
652363|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652364|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652365|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
652366|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652369|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652370|NCT00396565|E3|Reported Event|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
652371|NCT00396565|E2|Reported Event|Placebo|Two placebo tablets once daily for 6 weeks
652372|NCT00396565|E1|Reported Event|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
652373|NCT00396409|B3|Baseline|Total|Total of all reporting groups
652374|NCT00396409|B2|Baseline|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652375|NCT00396409|B1|Baseline|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652376|NCT00396409|P2|Participant Flow|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652377|NCT00396409|P1|Participant Flow|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652378|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652379|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652380|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652381|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652382|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652383|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652384|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652385|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652386|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652387|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652388|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652389|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652390|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652391|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652392|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652393|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652394|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652395|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652396|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652397|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652398|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652399|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652400|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652401|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652402|NCT00396409|E4|Reported Event|Depigoid + Placebo 2008|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652403|NCT00396409|E3|Reported Event|Depigoid + Placebo 2007|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
652404|NCT00396409|E2|Reported Event|Depigoid + Omalizumab 2008|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652405|NCT00396409|E1|Reported Event|Depigoid + Omalizumab 2007|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
652406|NCT00396383|B1|Baseline|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652407|NCT00396383|P1|Participant Flow|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652624|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652408|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652409|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652410|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652411|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652412|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652413|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652414|NCT00396383|E1|Reported Event|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
652415|NCT00396331|B5|Baseline|Total|Total of all reporting groups
652416|NCT00396331|B4|Baseline|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652417|NCT00396331|B3|Baseline|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652418|NCT00396331|B2|Baseline|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652419|NCT00396331|B1|Baseline|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652420|NCT00396331|P1|Participant Flow|G-CSF Plus Plerixafor|Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652421|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652422|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652423|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652424|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652425|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652426|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652427|NCT00396331|O5|Outcome|All Patients|
652625|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652428|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652429|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652430|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652431|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652432|NCT00396331|O5|Outcome|All Patients|
652433|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652434|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652435|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652436|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652437|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652438|NCT00396331|O5|Outcome|All Patients|
652439|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652440|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652441|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652442|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652443|NCT00396331|O5|Outcome|All Patients|
652444|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652445|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652626|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652446|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652447|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652448|NCT00396331|O5|Outcome|All Patients|
652449|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652450|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652451|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652452|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652453|NCT00396331|O5|Outcome|All Patients|
652454|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652455|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652456|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652457|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652458|NCT00396331|O5|Outcome|All Patients|
652459|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652460|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652461|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652462|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652463|NCT00396331|O5|Outcome|All Patients|
652464|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652465|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652466|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652467|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652468|NCT00396331|E4|Reported Event|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652469|NCT00396331|E3|Reported Event|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652470|NCT00396331|E2|Reported Event|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652471|NCT00396331|E1|Reported Event|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
652472|NCT00396318|B1|Baseline|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652473|NCT00396318|P1|Participant Flow|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652474|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652475|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652627|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652628|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652476|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652477|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652478|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652479|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652480|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652481|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652482|NCT00396318|E1|Reported Event|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
652483|NCT00396292|B3|Baseline|Total|Total of all reporting groups
652484|NCT00396292|B2|Baseline|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
652485|NCT00396292|B1|Baseline|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
652486|NCT00396292|P2|Participant Flow|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
652487|NCT00396292|P1|Participant Flow|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
652488|NCT00396292|O2|Outcome|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
652489|NCT00396292|O1|Outcome|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
652490|NCT00396292|E2|Reported Event|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
652491|NCT00396292|E1|Reported Event|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
652492|NCT00396279|B1|Baseline|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652493|NCT00396279|P1|Participant Flow|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652494|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652495|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652496|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652497|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652498|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652499|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
652500|NCT00396279|E1|Reported Event|Denosumab 120 mg Q4W|Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
652501|NCT00396266|B3|Baseline|Total|Total of all reporting groups
652502|NCT00396266|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652503|NCT00396266|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652504|NCT00396266|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652629|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652630|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652631|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652505|NCT00396266|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652506|NCT00396266|O1|Outcome|PD Subgroup|Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
652507|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
652508|NCT00396266|O3|Outcome|Total|All patients.
652509|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652510|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652511|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
652512|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
652513|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
652514|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
652515|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
652516|NCT00396266|O1|Outcome|Non-hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652517|NCT00396266|O3|Outcome|Total|All patients.
652518|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652519|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652520|NCT00396266|O3|Outcome|Total|All patients.
652521|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652522|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652523|NCT00396266|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652524|NCT00396266|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
652525|NCT00396253|B1|Baseline|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
656782|NCT00386334|O1|Outcome|Placebo|Placebo tablets
652526|NCT00396253|P1|Participant Flow|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652527|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652528|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652529|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652530|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652531|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652532|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652533|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652534|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652535|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652536|NCT00396253|E1|Reported Event|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
652537|NCT00396201|B1|Baseline|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652538|NCT00396201|P1|Participant Flow|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) [10 µg/kg each day (QD)] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652632|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652539|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652540|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652541|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652542|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652543|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652544|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652545|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652546|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652547|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652548|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652549|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652550|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652551|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652552|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652553|NCT00396201|E1|Reported Event|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
652554|NCT00396162|B3|Baseline|Total|Total of all reporting groups
652555|NCT00396162|B2|Baseline|Placebo Pill|"Placebo pills on same schedule as active intervention.~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
652556|NCT00396162|B1|Baseline|Probiotic|"drug~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
652557|NCT00396162|P2|Participant Flow|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652633|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652558|NCT00396162|P1|Participant Flow|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652559|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652560|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652561|NCT00396162|O2|Outcome|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652562|NCT00396162|O1|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652563|NCT00396162|O2|Outcome|Probiotic|"L. rhamnosus R0011 strain~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
652564|NCT00396162|O1|Outcome|Placebo Pill|"Placebo pills on same schedule as active intervention.~Placebo: Placebo pill"
652565|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652566|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652567|NCT00396162|E2|Reported Event|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652568|NCT00396162|E1|Reported Event|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
652569|NCT00396136|B1|Baseline|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
652570|NCT00396136|P1|Participant Flow|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
652571|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
652572|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
652573|NCT00396136|E1|Reported Event|Group 1|
652574|NCT00396097|B3|Baseline|Total|Total of all reporting groups
652575|NCT00396097|B2|Baseline|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
652576|NCT00396097|B1|Baseline|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652577|NCT00396097|P2|Participant Flow|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
652578|NCT00396097|P1|Participant Flow|Standard Dose Arm|The participants received subcutaneous genotropin, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652579|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
652580|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
652581|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
652582|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652583|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24/mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
652584|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
652634|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652635|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652636|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652637|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652585|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
652586|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652587|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
652588|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
652589|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
652590|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652591|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
652592|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652593|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
652594|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652595|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
652596|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652597|NCT00396097|E2|Reported Event|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
652598|NCT00396097|E1|Reported Event|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
652599|NCT00396084|B7|Baseline|Total|Total of all reporting groups
652600|NCT00396084|B6|Baseline|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652601|NCT00396084|B5|Baseline|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652602|NCT00396084|B4|Baseline|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
652603|NCT00396084|B3|Baseline|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
652604|NCT00396084|B2|Baseline|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652605|NCT00396084|B1|Baseline|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652606|NCT00396084|P6|Participant Flow|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652607|NCT00396084|P5|Participant Flow|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652608|NCT00396084|P4|Participant Flow|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
652609|NCT00396084|P3|Participant Flow|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
652610|NCT00396084|P2|Participant Flow|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652611|NCT00396084|P1|Participant Flow|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652612|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652613|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid 600 mg/day x 7 days
652614|NCT00396084|O1|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652615|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652616|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652617|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652618|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652619|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652620|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652621|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652622|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652623|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652638|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
652639|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652640|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652641|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652642|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652643|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652644|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652645|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652646|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652647|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652648|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652649|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
652650|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652651|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652652|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652653|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652654|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652655|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652656|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652657|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652658|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
652659|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
652660|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652661|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652662|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652663|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652664|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652665|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652666|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652667|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652668|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652669|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652670|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652671|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652672|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652673|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652674|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652675|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652676|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652677|NCT00396084|E6|Reported Event|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
652678|NCT00396084|E5|Reported Event|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
652679|NCT00396084|E4|Reported Event|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
652680|NCT00396084|E3|Reported Event|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
652681|NCT00396084|E2|Reported Event|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
652682|NCT00396084|E1|Reported Event|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
652683|NCT00396032|B3|Baseline|Total|Total of all reporting groups
652684|NCT00396032|B2|Baseline|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652685|NCT00396032|B1|Baseline|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652686|NCT00396032|P2|Participant Flow|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652687|NCT00396032|P1|Participant Flow|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652688|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652689|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652690|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652691|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652692|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652693|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652694|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
656783|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
652695|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652696|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652697|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652698|NCT00396032|E2|Reported Event|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652699|NCT00396032|E1|Reported Event|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
652700|NCT00396019|B4|Baseline|Total|Total of all reporting groups
652701|NCT00396019|B3|Baseline|Stratum 3 Tumor Growth With or Without Symptoms|Peg-intron given every week
652702|NCT00396019|B2|Baseline|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
652703|NCT00396019|B1|Baseline|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
652704|NCT00396019|P3|Participant Flow|Stratum 3 Tumor Growth With or Without Symptoms|Peg-intron given every week
652705|NCT00396019|P2|Participant Flow|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
652706|NCT00396019|P1|Participant Flow|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
652707|NCT00396019|O1|Outcome|Stratum 3: Tumor Growth With or Without Symptoms|Peg-intron given every week
652708|NCT00396019|O1|Outcome|Stratum 3: Tumor Growth With or Without Symptoms|Peg-intron given every week
652709|NCT00396019|O1|Outcome|Stratum 2 Symptoms on Tumor Growth|Peg-intron given every week
652710|NCT00396019|O2|Outcome|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
652711|NCT00396019|O1|Outcome|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
652712|NCT00396019|E3|Reported Event|Stratum 3 Tumor Growth With or Without Symptoms|Peg-intron given every week
652713|NCT00396019|E2|Reported Event|Stratum 2 Symptoms no Tumor Growth|Peg-intron given every week
652714|NCT00396019|E1|Reported Event|Stratum 1 No Symptom With or Withour Tumor Growth|Peg-intron given every week
652715|NCT00396006|B1|Baseline|Participants Treated With ARALAST Fr. IV-1|
652716|NCT00396006|P1|Participant Flow|Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1)|Weekly infusions of ARALAST Fr. IV-1 were administered to participants at a dosage of 60 mg/kg
652717|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
652718|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
652719|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652720|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652721|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652722|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652723|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652724|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652725|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652726|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652727|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
652728|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
652729|NCT00396006|E1|Reported Event|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
652730|NCT00395993|B3|Baseline|Total|Total of all reporting groups
652731|NCT00395993|B2|Baseline|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
652732|NCT00395993|B1|Baseline|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
652733|NCT00395993|P2|Participant Flow|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
652734|NCT00395993|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
652735|NCT00395993|O2|Outcome|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
652736|NCT00395993|O1|Outcome|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
652737|NCT00395993|E2|Reported Event|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
652834|NCT00395746|B2|Baseline|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652738|NCT00395993|E1|Reported Event|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
652739|NCT00395967|B1|Baseline|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652740|NCT00395967|P1|Participant Flow|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652741|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652742|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652743|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652744|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652745|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652746|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
652747|NCT00395967|E1|Reported Event|All Patients|All patients (3 NHL, 1 MM, and 1 HD).
652748|NCT00395876|B3|Baseline|Total|Total of all reporting groups
652749|NCT00395876|B2|Baseline|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652750|NCT00395876|B1|Baseline|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652751|NCT00395876|P2|Participant Flow|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652752|NCT00395876|P1|Participant Flow|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652753|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
653280|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
652754|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652755|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652756|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652757|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652758|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652759|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652760|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652761|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652762|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652763|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652835|NCT00395746|B1|Baseline|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
656784|NCT00386334|O1|Outcome|Placebo|Placebo tablets
652764|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652765|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652766|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652767|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652768|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652769|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652770|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652771|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652772|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652773|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652836|NCT00395746|P3|Participant Flow|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652774|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652775|NCT00395876|E2|Reported Event|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652776|NCT00395876|E1|Reported Event|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
652777|NCT00395863|B3|Baseline|Total|Total of all reporting groups
652778|NCT00395863|B2|Baseline|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
652779|NCT00395863|B1|Baseline|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
652780|NCT00395863|P2|Participant Flow|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
652781|NCT00395863|P1|Participant Flow|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
652782|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652783|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652784|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652785|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652786|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652787|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652788|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652789|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652790|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652791|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652792|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652793|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652794|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652795|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652796|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652797|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652798|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
652799|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
652800|NCT00395863|O3|Outcome|Reader 3|
652801|NCT00395863|O2|Outcome|Reader 2|
652802|NCT00395863|O1|Outcome|Reader 1|
652803|NCT00395863|O3|Outcome|Reader 3|
652804|NCT00395863|O2|Outcome|Reader 2|
652805|NCT00395863|O1|Outcome|Reader 1|
652806|NCT00395863|O3|Outcome|Reader 3|
652807|NCT00395863|O2|Outcome|Reader 2|
652808|NCT00395863|O1|Outcome|Reader 1|
652809|NCT00395863|E2|Reported Event|Magnevist|Adverse events experienced by patients occurred relative to the administration of Magnevist.
652810|NCT00395863|E1|Reported Event|MultiHance|Adverse events experienced by patients occurred relative to the administration of MultiHance.
652811|NCT00395850|B5|Baseline|Total|Total of all reporting groups
652812|NCT00395850|B4|Baseline|Disulfiram 500|Disulfiram at 500 mg/day
652813|NCT00395850|B3|Baseline|Disulfiram 375|Disulfiram at 375 mg/day
652814|NCT00395850|B2|Baseline|Disulfiram 250|disulfiram at 250 mg/day
652815|NCT00395850|B1|Baseline|Placebo|microcrystalline cellulose
652816|NCT00395850|P4|Participant Flow|Disulfiram 500|Disulfiram at 500 mg/day
652817|NCT00395850|P3|Participant Flow|Disulfiram 375|Disulfiram at 375 mg/day
652818|NCT00395850|P2|Participant Flow|Disulfiram 250|disulfiram at 250 mg/day
652819|NCT00395850|P1|Participant Flow|Placebo|microcrystalline cellulose
652820|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
652821|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
652822|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
652823|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
652824|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
652825|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
652826|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
652827|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
652828|NCT00395850|E4|Reported Event|Disulfiram 500|Disulfiram at 500 mg/day
652829|NCT00395850|E3|Reported Event|Disulfiram 375|Disulfiram at 375 mg/day
652830|NCT00395850|E2|Reported Event|Disulfiram 250|disulfiram at 250 mg/day
652831|NCT00395850|E1|Reported Event|Placebo|microcrystalline cellulose
652832|NCT00395746|B4|Baseline|Total|Total of all reporting groups
652833|NCT00395746|B3|Baseline|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
653281|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
652837|NCT00395746|P2|Participant Flow|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652838|NCT00395746|P1|Participant Flow|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652839|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652840|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652841|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652842|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652843|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652844|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652845|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652846|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652847|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652848|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652849|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652850|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652851|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652852|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652853|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652854|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652855|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652856|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652857|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652858|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652859|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652860|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652861|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652862|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652863|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652864|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652865|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652866|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652867|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652868|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652869|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652870|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652871|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652872|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652873|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652874|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652875|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652876|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652877|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
653282|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
652878|NCT00395746|E3|Reported Event|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652879|NCT00395746|E2|Reported Event|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652880|NCT00395746|E1|Reported Event|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
652881|NCT00395733|B3|Baseline|Total|Total of all reporting groups
652882|NCT00395733|B2|Baseline|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
652883|NCT00395733|B1|Baseline|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
652884|NCT00395733|P2|Participant Flow|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
652885|NCT00395733|P1|Participant Flow|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
652886|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652887|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652888|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652889|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652890|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652891|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652892|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652893|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652894|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652895|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652896|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652897|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652898|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652899|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652900|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
656785|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
652901|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652902|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652903|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652904|NCT00395733|E2|Reported Event|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652905|NCT00395733|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
652906|NCT00395694|B3|Baseline|Total|Total of all reporting groups
652907|NCT00395694|B2|Baseline|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652908|NCT00395694|B1|Baseline|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652909|NCT00395694|P2|Participant Flow|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652910|NCT00395694|P1|Participant Flow|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652911|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652912|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652913|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652970|NCT00395512|P2|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652914|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652915|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652916|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652917|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652918|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652919|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652920|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652921|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652971|NCT00395512|P1|Participant Flow|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652972|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652973|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
656786|NCT00386334|O1|Outcome|Placebo|Placebo tablets
652922|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652923|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652924|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652925|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652926|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652927|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652928|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652929|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652938|NCT00395694|E2|Reported Event|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
653283|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
652930|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652931|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652932|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652933|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652934|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652935|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652936|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652937|NCT00395694|E3|Reported Event|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
652967|NCT00395512|B1|Baseline|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652968|NCT00395512|P4|Participant Flow|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652969|NCT00395512|P3|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
656787|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
652939|NCT00395694|E1|Reported Event|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
652940|NCT00395642|B1|Baseline|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
652941|NCT00395642|P1|Participant Flow|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
652942|NCT00395642|O1|Outcome|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
652943|NCT00395642|E1|Reported Event|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
652944|NCT00395629|B4|Baseline|Total|Total of all reporting groups
652945|NCT00395629|B3|Baseline|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652946|NCT00395629|B2|Baseline|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652947|NCT00395629|B1|Baseline|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652948|NCT00395629|P3|Participant Flow|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652949|NCT00395629|P2|Participant Flow|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652950|NCT00395629|P1|Participant Flow|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652951|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652952|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652953|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652954|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652955|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652956|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652957|NCT00395629|E6|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652958|NCT00395629|E5|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652959|NCT00395629|E4|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652960|NCT00395629|E3|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652961|NCT00395629|E2|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652962|NCT00395629|E1|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
652963|NCT00395512|B5|Baseline|Total|Total of all reporting groups
652964|NCT00395512|B4|Baseline|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652965|NCT00395512|B3|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652966|NCT00395512|B2|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653275|NCT00395291|P2|Participant Flow|Placebo First, Then MK-0677|Subjects took Placebo for at least 30 days.
652974|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652975|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652976|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652977|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652978|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652979|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652980|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652981|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652982|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652983|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652984|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652985|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652986|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652987|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652988|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652989|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652990|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652991|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652992|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652993|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652994|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652995|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
652996|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652997|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
652998|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
652999|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653000|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653001|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653002|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653003|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653004|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653005|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653006|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653007|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653008|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653009|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653010|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653011|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
656788|NCT00386334|O1|Outcome|Placebo|Placebo tablets
653012|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653013|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653014|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653015|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653016|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653017|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653018|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653019|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653020|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653021|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653022|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653023|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653024|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653025|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653026|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653027|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653028|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653029|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653030|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653031|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653032|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653033|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653034|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653035|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653036|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653037|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653038|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653039|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653040|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653041|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653042|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653043|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653044|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653045|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653046|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653047|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653048|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653049|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
656789|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
653050|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653051|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653052|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653053|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653054|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653055|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653056|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653057|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653058|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653059|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653060|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653061|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653062|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653063|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653064|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653065|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653066|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653067|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653068|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653069|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653070|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653071|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653072|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653073|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653074|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653075|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653076|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653077|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653078|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653079|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653080|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653081|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653082|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653083|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653084|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653085|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653086|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653087|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
656790|NCT00386334|O1|Outcome|Placebo|Placebo tablets
653088|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653089|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653090|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653091|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653092|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653093|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653094|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653095|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653096|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653097|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653098|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653099|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653100|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653101|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653102|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653103|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653104|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653105|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653106|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653107|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653108|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653109|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653110|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653111|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653112|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653113|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653114|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653115|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653116|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653117|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653118|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653119|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653120|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653121|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653122|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653123|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653124|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653125|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
656791|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
653126|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653127|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653128|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653129|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653130|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653131|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653132|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653133|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653134|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653135|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653136|NCT00395512|E4|Reported Event|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653137|NCT00395512|E3|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
653138|NCT00395512|E2|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
653139|NCT00395512|E1|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
653140|NCT00395486|B3|Baseline|Total|Total of all reporting groups
653141|NCT00395486|B2|Baseline|Atorvastatin|10mg
653142|NCT00395486|B1|Baseline|Rosuvastatin|10mg
653143|NCT00395486|P2|Participant Flow|Atorvastatin|10mg
653144|NCT00395486|P1|Participant Flow|Rosuvastatin|10mg
653145|NCT00395486|O2|Outcome|Atorvastatin|10mg
653146|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653147|NCT00395486|O2|Outcome|Atorvastatin|10mg
653148|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653149|NCT00395486|O2|Outcome|Atorvastatin|10mg
653150|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653151|NCT00395486|O2|Outcome|Atorvastatin|10mg
653152|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653153|NCT00395486|O2|Outcome|Atorvastatin|10mg
653154|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653155|NCT00395486|O2|Outcome|Atorvastatin|10mg
653156|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653157|NCT00395486|O2|Outcome|Atorvastatin|10mg
653158|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653159|NCT00395486|O2|Outcome|Atorvastatin|10mg
653160|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653161|NCT00395486|O2|Outcome|Atorvastatin|10mg
653162|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653163|NCT00395486|O2|Outcome|Atorvastatin|10mg
653164|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653165|NCT00395486|O2|Outcome|Atorvastatin|10mg
653166|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653167|NCT00395486|O2|Outcome|Atorvastatin|10mg
653168|NCT00395486|O1|Outcome|Rosuvastatin|10mg
653169|NCT00395486|E2|Reported Event|Atorvastatin|10mg
653170|NCT00395486|E1|Reported Event|Rosuvastatin|10mg
653171|NCT00395460|B3|Baseline|Total|Total of all reporting groups
653172|NCT00395460|B2|Baseline|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653173|NCT00395460|B1|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653174|NCT00395460|P2|Participant Flow|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653175|NCT00395460|P1|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653176|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653177|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653178|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653179|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653180|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653181|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653182|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653284|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653183|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653184|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653185|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653186|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653187|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653188|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653189|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653190|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653191|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653192|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653193|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653194|NCT00395460|E2|Reported Event|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
653195|NCT00395460|E1|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
653196|NCT00395447|B3|Baseline|Total|Total of all reporting groups
653197|NCT00395447|B2|Baseline|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
653198|NCT00395447|B1|Baseline|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
653199|NCT00395447|P2|Participant Flow|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
653200|NCT00395447|P1|Participant Flow|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
653201|NCT00395447|O2|Outcome|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
653202|NCT00395447|O1|Outcome|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
653203|NCT00395447|E2|Reported Event|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
653204|NCT00395447|E1|Reported Event|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
653205|NCT00395343|B3|Baseline|Total|Total of all reporting groups
653206|NCT00395343|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653207|NCT00395343|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653208|NCT00395343|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653209|NCT00395343|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653210|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653211|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653276|NCT00395291|P1|Participant Flow|MK-0677 First, Then Placebo|Subjects took 25mg of MK-0677 for at least 30 Days.
653277|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653212|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653213|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653214|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653215|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653216|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653217|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653218|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653219|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653220|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653221|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653222|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653223|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653224|NCT00395343|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653225|NCT00395343|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
653226|NCT00395304|B1|Baseline|All Participants|All participants randomized to the six crossover sequences
653227|NCT00395304|P6|Participant Flow|1xICS + LTRA, 1xICS + LABA, 2xICS|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653228|NCT00395304|P5|Participant Flow|1xICS + LTRA, 2xICS, 1xICS + LABA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653229|NCT00395304|P4|Participant Flow|1xICS + LABA, 1xICS + LTRA, 2xICS|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653230|NCT00395304|P3|Participant Flow|1xICS +LABA, 2xICS, 1xICS + LTRA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653278|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653279|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653231|NCT00395304|P2|Participant Flow|2xICS, 1xICS + LTRA, 1xICS + LABA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653232|NCT00395304|P1|Participant Flow|2xICS, 1xICS + LABA, 1xICS + LTRA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653233|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653234|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653235|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653236|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653237|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653238|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653239|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653240|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653241|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653242|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653243|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653244|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653245|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653246|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653247|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653248|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653249|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653250|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653251|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653252|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653253|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653254|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653255|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653256|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653257|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653258|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653259|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653260|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653261|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653262|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653263|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653264|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653265|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653266|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653267|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653268|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653269|NCT00395304|O3|Outcome|1xICS + LTRA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
653270|NCT00395304|O2|Outcome|1xICS + LABA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
653271|NCT00395304|O1|Outcome|2xICS|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
653272|NCT00395304|O1|Outcome|All Participants|All participants randomized to the six crossover sequences
653273|NCT00395304|E1|Reported Event|All Participants|All participants randomized to the six crossover sequences
653274|NCT00395291|B1|Baseline|Entire Study Population|Includes groups randomized to placebo first and MK-0677 first.
653285|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653286|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653287|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653288|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653289|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653290|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653291|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653292|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653293|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653294|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653295|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653296|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653297|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653298|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653299|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653300|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653301|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
653302|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653303|NCT00395291|E2|Reported Event|Placebo|Subjects took Placebo for at least 30 days.
653304|NCT00395291|E1|Reported Event|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
653305|NCT00395226|B3|Baseline|Total|Total of all reporting groups
653306|NCT00395226|B2|Baseline|Zinc Sulfate|
653307|NCT00395226|B1|Baseline|Placebo (Lactose)|
653308|NCT00395226|P2|Participant Flow|Zinc Sulfate|
653309|NCT00395226|P1|Participant Flow|Placebo (Lactose)|
653310|NCT00395226|O2|Outcome|Zinc Sulfate|
653311|NCT00395226|O1|Outcome|Placebo (Lactose)|
653312|NCT00395226|E2|Reported Event|Zinc Sulfate|
653313|NCT00395226|E1|Reported Event|Placebo (Lactose)|
653314|NCT00395161|B3|Baseline|Total|Total of all reporting groups
653315|NCT00395161|B2|Baseline|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
653316|NCT00395161|B1|Baseline|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
653317|NCT00395161|P2|Participant Flow|Enteral Whey Protein, IV Saline|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
653318|NCT00395161|P1|Participant Flow|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
653319|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
653320|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
653321|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
653322|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
653323|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
653324|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
653325|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
653326|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
653327|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
653328|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
653329|NCT00395161|E2|Reported Event|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
653330|NCT00395161|E1|Reported Event|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
653331|NCT00395135|B3|Baseline|Total|Total of all reporting groups
653332|NCT00395135|B2|Baseline|Year 1 - Matching Placebo BID|matching placebo tablets
653333|NCT00395135|B1|Baseline|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
653334|NCT00395135|P5|Participant Flow|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2.
653335|NCT00395135|P4|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
653336|NCT00395135|P3|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
653337|NCT00395135|P2|Participant Flow|Year 1 - Matching Placebo BID|matching placebo tablets
653338|NCT00395135|P1|Participant Flow|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
653339|NCT00395135|O3|Outcome|Placebo (Yr 1) / Placebo (Yr 2)|Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
653340|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
653341|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
653342|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
653343|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
653344|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 with a Responder status and randomized to placebo in Year 2."
653345|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 study with a Responder status and randomized to lorcaserin in Year 2."
653346|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
653347|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
653348|NCT00395135|E5|Reported Event|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|matching placebo tablets
653349|NCT00395135|E4|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|lorcaserin 10 mg BID tablets, matching placebo tablets
653350|NCT00395135|E3|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|lorcaserin 10 mg BID tablets
653351|NCT00395135|E2|Reported Event|Year 1 - Matching Placebo BID|matching placebo tablets
653352|NCT00395135|E1|Reported Event|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
653353|NCT00395083|B3|Baseline|Total|Total of all reporting groups
653354|NCT00395083|B2|Baseline|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
653355|NCT00395083|B1|Baseline|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
653356|NCT00395083|P2|Participant Flow|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
653357|NCT00395083|P1|Participant Flow|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
653358|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
653359|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
653360|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
653361|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
653362|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
653363|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
653364|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
653365|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
653433|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653434|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653435|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653366|NCT00395083|E2|Reported Event|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
653367|NCT00395083|E1|Reported Event|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
653368|NCT00395057|B5|Baseline|Total|Total of all reporting groups
653369|NCT00395057|B4|Baseline|Ranibizumab 500 ug|Ranibizumab 500 ug
653370|NCT00395057|B3|Baseline|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653371|NCT00395057|B2|Baseline|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653372|NCT00395057|B1|Baseline|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653373|NCT00395057|P4|Participant Flow|Ranibizumab 500 ug|Ranibizumab 500 ug
653374|NCT00395057|P3|Participant Flow|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653375|NCT00395057|P2|Participant Flow|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653376|NCT00395057|P1|Participant Flow|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653377|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
653378|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653379|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653380|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653381|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
653382|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653383|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653384|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653385|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
653386|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653387|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653388|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653389|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
653390|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653391|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653392|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653393|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
653394|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653395|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653396|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653397|NCT00395057|E4|Reported Event|Ranibizumab 500 ug|Ranibizumab 500 ug
653398|NCT00395057|E3|Reported Event|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
653399|NCT00395057|E2|Reported Event|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
653400|NCT00395057|E1|Reported Event|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
653401|NCT00395044|B3|Baseline|Total|Total of all reporting groups
653402|NCT00395044|B2|Baseline|Placebo|1200mg/d of Placebo
653403|NCT00395044|B1|Baseline|Gabapentin|1200 mg/daily of Gabapentin
653404|NCT00395044|P2|Participant Flow|Placebo|Matched Placebo
653405|NCT00395044|P1|Participant Flow|Gabapentin|1200 mg/daily of Gabapentin
653406|NCT00395044|O2|Outcome|Placebo|Matched Placebo
653407|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
653408|NCT00395044|O2|Outcome|Placebo|Matched Placebo
653409|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
653410|NCT00395044|O2|Outcome|Placebo|Matched Placebo
653411|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
653412|NCT00395044|O2|Outcome|Placebo|Matched Placebo
653413|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
653414|NCT00395044|O2|Outcome|Placebo|Matched Placebo
653415|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
653416|NCT00395044|O2|Outcome|Placebo|Matched Placebo
653417|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
653418|NCT00395044|O2|Outcome|Placebo|Matched Placebo
653419|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
653420|NCT00395044|E2|Reported Event|Placebo|1200mg/d of Placebo
653421|NCT00395044|E1|Reported Event|Gabapentin|1200 mg/daily of Gabapentin
653422|NCT00395018|B1|Baseline|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653423|NCT00395018|P1|Participant Flow|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653424|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653425|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653426|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653427|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653428|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653429|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653430|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653431|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653432|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653436|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653437|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653438|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653439|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653440|NCT00395018|E1|Reported Event|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
653441|NCT00394953|B3|Baseline|Total|Total of all reporting groups
653442|NCT00394953|B2|Baseline|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653443|NCT00394953|B1|Baseline|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653444|NCT00394953|P2|Participant Flow|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
653445|NCT00394953|P1|Participant Flow|MIRCERA|Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653446|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653447|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653448|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653449|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653450|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653451|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653452|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653453|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653454|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653455|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653456|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653457|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653458|NCT00394953|E2|Reported Event|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
653459|NCT00394953|E1|Reported Event|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
653460|NCT00394914|B3|Baseline|Total|Total of all reporting groups
653461|NCT00394914|B2|Baseline|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653500|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653462|NCT00394914|B1|Baseline|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653463|NCT00394914|P3|Participant Flow|Placebo|Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653464|NCT00394914|P2|Participant Flow|Pleconaril|Participants were randomized to receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653465|NCT00394914|P1|Participant Flow|All Participants (Pre-randomization)|All participants on study prior to randomization.
653466|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653467|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653468|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653469|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653470|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653471|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653472|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653473|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653474|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653475|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653476|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653477|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653478|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653479|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653480|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653481|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653482|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653483|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653484|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653485|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653486|NCT00394914|E2|Reported Event|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
653487|NCT00394914|E1|Reported Event|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
653488|NCT00394901|B5|Baseline|Total|Total of all reporting groups
653489|NCT00394901|B4|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653490|NCT00394901|B3|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653491|NCT00394901|B2|Baseline|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653492|NCT00394901|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653493|NCT00394901|P4|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653494|NCT00394901|P3|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653495|NCT00394901|P2|Participant Flow|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653496|NCT00394901|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653497|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653498|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653499|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653501|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653502|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653503|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653504|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653505|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653506|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653507|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653508|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653509|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653510|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653511|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653512|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653513|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653514|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653515|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653516|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653517|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653518|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653519|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653520|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653521|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653522|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653523|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653524|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653525|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653526|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653527|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653528|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653529|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653530|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653531|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653532|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653533|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653534|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653535|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653536|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653537|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653538|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653539|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653540|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653541|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653542|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653543|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653544|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653545|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653546|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653547|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653548|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653549|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653550|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653551|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653552|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653553|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653554|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653555|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653556|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653557|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653558|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653559|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653560|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653561|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653562|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653563|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653564|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653565|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653566|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653567|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653568|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653569|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653570|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653571|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653572|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653573|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653574|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653575|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653576|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653577|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653578|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653579|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653580|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653581|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653582|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
656792|NCT00386334|O1|Outcome|Placebo|Placebo tablets
653583|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653584|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653585|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653586|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653587|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653588|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653589|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653590|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653591|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653592|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653593|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653594|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653595|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653596|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653597|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653598|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653599|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653600|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653601|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653602|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653603|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653604|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653605|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653606|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653607|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653608|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653609|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653610|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653611|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653612|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653613|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653614|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653615|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653616|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653617|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653618|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653619|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653620|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653621|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653622|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653623|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653624|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653625|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653626|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653627|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653628|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653629|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653630|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653631|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653632|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653633|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653634|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653635|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653636|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653637|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653638|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653639|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653640|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653641|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653642|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653643|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653644|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653645|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653646|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653647|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653648|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653649|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653650|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653651|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653652|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653653|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653654|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653655|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653656|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653657|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653658|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653659|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653660|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653661|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653662|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653663|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653664|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653665|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653666|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653667|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653668|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653669|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653670|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653671|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653672|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653673|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653674|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653675|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653676|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653677|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653678|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653679|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653680|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653681|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653682|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653683|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653684|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653685|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653686|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653687|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653688|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653689|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653690|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653691|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653692|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653693|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653694|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653695|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653696|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653697|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653698|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653699|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653700|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653701|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653702|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653703|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653704|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653705|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653706|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
656793|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
653707|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653708|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653709|NCT00394901|O3|Outcome|Expected Pregabalin Exposure of 600 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 300 mg/day and subjects who received pregabalin 600 mg/day.
653710|NCT00394901|O2|Outcome|Expected Pregabalin Exposure of 300 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 150 mg/day and subjects with normal CLcr (> 60 mL/min) who received pregabalin 300 mg/day.
653711|NCT00394901|O1|Outcome|Placebo|Subjects who received matching placebo during a 13-week double-blind treatment phase.
653712|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653713|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653714|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653715|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653716|NCT00394901|E4|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
653717|NCT00394901|E3|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
653718|NCT00394901|E2|Reported Event|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
653719|NCT00394901|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
653720|NCT00394888|B4|Baseline|Total|Total of all reporting groups
653721|NCT00394888|B3|Baseline|Multiple Hemangiomas|Patients with multiple hemangiomas
653722|NCT00394888|B2|Baseline|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
653723|NCT00394888|B1|Baseline|Facial Hemangioma|Patients with large facial hemangioma.
653724|NCT00394888|P3|Participant Flow|Multiple Hemangiomas|Patients with multiple hemangiomas
653725|NCT00394888|P2|Participant Flow|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
653726|NCT00394888|P1|Participant Flow|Facial Hemangioma|Patients with large facial hemangioma.
653727|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
653728|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
653729|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
653730|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
653731|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
653732|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
653733|NCT00394888|E3|Reported Event|Multiple Hemangiomas|Patients with multiple hemangiomas
653734|NCT00394888|E2|Reported Event|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
653735|NCT00394888|E1|Reported Event|Facial Hemangioma|Patients with large facial hemangioma.
653736|NCT00394836|B3|Baseline|Total|Total of all reporting groups
653737|NCT00394836|B2|Baseline|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653738|NCT00394836|B1|Baseline|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653739|NCT00394836|P2|Participant Flow|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
653740|NCT00394836|P1|Participant Flow|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
653741|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653742|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653743|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653744|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653745|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653746|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653747|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653748|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653749|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653750|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
656794|NCT00386334|O1|Outcome|Placebo|Placebo tablets
653751|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653752|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653753|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653754|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653755|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653756|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653757|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653758|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653759|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653760|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653761|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653762|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653763|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653764|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653765|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653766|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653767|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653768|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653769|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653770|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653771|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653772|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653773|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653774|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653775|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653776|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653777|NCT00394836|E4|Reported Event|Ofatumumab 1000 mg: Extended Follow-up Phase|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
653778|NCT00394836|E3|Reported Event|Ofatumumab 500 mg: Extended Follow-up Phase|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
653779|NCT00394836|E2|Reported Event|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
653780|NCT00394836|E1|Reported Event|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
653781|NCT00394771|B5|Baseline|Total|Total of all reporting groups
653782|NCT00394771|B4|Baseline|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653783|NCT00394771|B3|Baseline|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653784|NCT00394771|B2|Baseline|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653892|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653785|NCT00394771|B1|Baseline|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653786|NCT00394771|P4|Participant Flow|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653787|NCT00394771|P3|Participant Flow|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653788|NCT00394771|P2|Participant Flow|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653789|NCT00394771|P1|Participant Flow|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653790|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653791|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653792|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653793|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653794|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653795|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653796|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653797|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653798|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653799|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653800|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653801|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653802|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653803|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653804|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653805|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653806|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653807|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653808|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653809|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653810|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653811|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653893|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653894|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653812|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653813|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653814|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653815|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653816|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653817|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653818|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653819|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653820|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653821|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653822|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653823|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653824|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653825|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653826|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653827|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653828|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653829|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653830|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653831|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653832|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653833|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653834|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653835|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653836|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653837|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653838|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653895|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653896|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653839|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653840|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653841|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653842|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653843|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653844|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653845|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653846|NCT00394771|E4|Reported Event|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
653847|NCT00394771|E3|Reported Event|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653848|NCT00394771|E2|Reported Event|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653849|NCT00394771|E1|Reported Event|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
653850|NCT00394706|B9|Baseline|Total|Total of all reporting groups
653851|NCT00394706|B8|Baseline|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
653852|NCT00394706|B7|Baseline|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
653853|NCT00394706|B6|Baseline|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
653854|NCT00394706|B5|Baseline|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
653855|NCT00394706|B4|Baseline|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
653856|NCT00394706|B3|Baseline|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
653857|NCT00394706|B2|Baseline|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
653858|NCT00394706|B1|Baseline|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
653859|NCT00394706|P8|Participant Flow|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
653860|NCT00394706|P7|Participant Flow|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
653861|NCT00394706|P6|Participant Flow|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
653862|NCT00394706|P5|Participant Flow|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
653863|NCT00394706|P4|Participant Flow|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
653864|NCT00394706|P3|Participant Flow|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
653865|NCT00394706|P2|Participant Flow|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
653866|NCT00394706|P1|Participant Flow|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
653867|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
653868|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
653869|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
653870|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
653871|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
653872|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
653873|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
653874|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
653875|NCT00394706|E8|Reported Event|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
653876|NCT00394706|E7|Reported Event|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
653877|NCT00394706|E6|Reported Event|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
653878|NCT00394706|E5|Reported Event|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
653879|NCT00394706|E4|Reported Event|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
653880|NCT00394706|E3|Reported Event|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
653881|NCT00394706|E2|Reported Event|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
653882|NCT00394706|E1|Reported Event|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
653883|NCT00394654|B3|Baseline|Total|Total of all reporting groups
653884|NCT00394654|B2|Baseline|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653885|NCT00394654|B1|Baseline|PLACEBO|
653886|NCT00394654|P2|Participant Flow|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653887|NCT00394654|P1|Participant Flow|PLACEBO|
653888|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653889|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653890|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653891|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653897|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653898|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653899|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653900|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653901|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653902|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653903|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653904|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653905|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653906|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653907|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653908|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653909|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653910|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653911|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653912|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653913|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653914|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653915|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653916|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653917|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653918|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653919|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653920|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653921|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653922|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653923|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653924|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653925|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653926|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653927|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653928|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653929|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653930|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653931|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653932|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653933|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653934|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653935|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653936|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653937|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653938|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653939|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653940|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653941|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653942|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653943|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653944|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653945|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
653946|NCT00394654|E2|Reported Event|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
653947|NCT00394654|E1|Reported Event|PLACEBO|
653948|NCT00394589|B4|Baseline|Total|Total of all reporting groups
653949|NCT00394589|B3|Baseline|Control|Continuation of infliximab 3 mg/kg every 8 weeks
653950|NCT00394589|B2|Baseline|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
653951|NCT00394589|B1|Baseline|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
653952|NCT00394589|P3|Participant Flow|Control|Continuation of infliximab 3 mg/kg every 8 weeks
653953|NCT00394589|P2|Participant Flow|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
653954|NCT00394589|P1|Participant Flow|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
653955|NCT00394589|O3|Outcome|Control|Continuation of infliximab 3 mg/kg every 8 weeks
653956|NCT00394589|O2|Outcome|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
653957|NCT00394589|O1|Outcome|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
653958|NCT00394589|E3|Reported Event|Control*Infliximab*3mg/kg Q8W|
653962|NCT00394524|B2|Baseline|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
653963|NCT00394524|B1|Baseline|Glucommander|insulin infusion per Glucommander
653964|NCT00394524|P2|Participant Flow|Standard Insulin Infusion|standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm
653965|NCT00394524|P1|Participant Flow|Glucommander|continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm
653966|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
653967|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
653968|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
653969|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
653970|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
653971|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
653972|NCT00394524|E2|Reported Event|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
653973|NCT00394524|E1|Reported Event|Glucommander|insulin infusion per Glucommander
653974|NCT00394472|B3|Baseline|Total|Total of all reporting groups
653975|NCT00394472|B2|Baseline|Placebo|Placebo capsules bid
653976|NCT00394472|B1|Baseline|AZD3355|AZD3355 capsules 65 mg bid
653977|NCT00394472|P2|Participant Flow|Placebo|Placebo capsules bid
653978|NCT00394472|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg bid
653979|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
653980|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
653981|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
653982|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
653983|NCT00394472|E2|Reported Event|Placebo|Placebo capsules bid
653984|NCT00394472|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg bid
653985|NCT00394433|B1|Baseline|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
653986|NCT00394433|P1|Participant Flow|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
653987|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
653988|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
653989|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
653990|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
653991|NCT00394433|E1|Reported Event|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
653992|NCT00394355|B5|Baseline|Total|Total of all reporting groups
653993|NCT00394355|B4|Baseline|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
653994|NCT00394355|B3|Baseline|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
653995|NCT00394355|B2|Baseline|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
653996|NCT00394355|B1|Baseline|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
653997|NCT00394355|P4|Participant Flow|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
653998|NCT00394355|P3|Participant Flow|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
653999|NCT00394355|P2|Participant Flow|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
654000|NCT00394355|P1|Participant Flow|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
654001|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
654002|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
654003|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
654004|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
654005|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
654006|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
654007|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
654008|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
654009|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
654010|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
654011|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
654012|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
654013|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
654014|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
654015|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
654016|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
654017|NCT00394355|E4|Reported Event|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
654018|NCT00394355|E3|Reported Event|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
654019|NCT00394355|E2|Reported Event|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
654020|NCT00394355|E1|Reported Event|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
654021|NCT00394329|B5|Baseline|Total|Total of all reporting groups
654022|NCT00394329|B4|Baseline|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654023|NCT00394329|B3|Baseline|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654024|NCT00394329|B2|Baseline|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654025|NCT00394329|B1|Baseline|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654026|NCT00394329|P4|Participant Flow|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654027|NCT00394329|P3|Participant Flow|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654028|NCT00394329|P2|Participant Flow|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654029|NCT00394329|P1|Participant Flow|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
656795|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
654030|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654031|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654032|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654033|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654034|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654035|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654036|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654037|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654038|NCT00394329|O4|Outcome|Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654039|NCT00394329|O3|Outcome|Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654040|NCT00394329|O2|Outcome|Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654041|NCT00394329|O1|Outcome|Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654042|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654043|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654044|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654060|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654133|NCT00394212|B2|Baseline|Sham Endoscopy|Sham Endoscopy (suturing not performed)
656796|NCT00386334|O1|Outcome|Placebo|Placebo tablets
654045|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654046|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654047|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654048|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654049|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654050|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654051|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654052|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654053|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654054|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654055|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654056|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654057|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654058|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654059|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654098|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654134|NCT00394212|B1|Baseline|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
654061|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654062|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654063|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654064|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654065|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654066|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654067|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654068|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654069|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654070|NCT00394329|E4|Reported Event|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654071|NCT00394329|E3|Reported Event|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654072|NCT00394329|E2|Reported Event|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
654073|NCT00394329|E1|Reported Event|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
654074|NCT00394277|B5|Baseline|Total|Total of all reporting groups
654075|NCT00394277|B4|Baseline|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654076|NCT00394277|B3|Baseline|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654131|NCT00394251|E1|Reported Event|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654132|NCT00394212|B3|Baseline|Total|Total of all reporting groups
654077|NCT00394277|B2|Baseline|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654078|NCT00394277|B1|Baseline|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654079|NCT00394277|P4|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654080|NCT00394277|P3|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654081|NCT00394277|P2|Participant Flow|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654082|NCT00394277|P1|Participant Flow|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654083|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654084|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654085|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654086|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654087|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654088|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654089|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654090|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654091|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654092|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654093|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654094|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654095|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654096|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654097|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654099|NCT00394277|E4|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654100|NCT00394277|E3|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654101|NCT00394277|E2|Reported Event|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
654102|NCT00394277|E1|Reported Event|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
654103|NCT00394251|B3|Baseline|Total|Total of all reporting groups
654104|NCT00394251|B2|Baseline|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654105|NCT00394251|B1|Baseline|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654106|NCT00394251|P2|Participant Flow|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654107|NCT00394251|P1|Participant Flow|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654108|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654109|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
654110|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654111|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
654112|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654113|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654114|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654115|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654116|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654117|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654118|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654119|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654120|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654121|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654122|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654123|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
654124|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654125|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
654126|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654127|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654128|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654129|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654130|NCT00394251|E2|Reported Event|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
654135|NCT00394212|P2|Participant Flow|Sham Endoscopy|Sham Endoscopy (suturing not performed)
654136|NCT00394212|P1|Participant Flow|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
654137|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
654138|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
654139|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
654140|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
654141|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
654142|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
654143|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
654144|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
654145|NCT00394212|E2|Reported Event|Sham Endoscopy|Sham Endoscopy (suturing not performed)
654146|NCT00394212|E1|Reported Event|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
654147|NCT00394095|B3|Baseline|Total|Total of all reporting groups
654148|NCT00394095|B2|Baseline|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
654149|NCT00394095|B1|Baseline|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
654150|NCT00394095|P2|Participant Flow|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
654151|NCT00394095|P1|Participant Flow|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
654152|NCT00394095|O2|Outcome|Comparator Group: Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
654153|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
654154|NCT00394095|O2|Outcome|Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
654155|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
654156|NCT00394095|E2|Reported Event|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
654157|NCT00394095|E1|Reported Event|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
654158|NCT00394082|B1|Baseline|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654159|NCT00394082|P1|Participant Flow|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654160|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654161|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654162|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654163|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654164|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654165|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654236|NCT00393861|B1|Baseline|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
654279|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654166|NCT00394082|E1|Reported Event|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
654167|NCT00393978|B3|Baseline|Total|Total of all reporting groups
654168|NCT00393978|B2|Baseline|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
654169|NCT00393978|B1|Baseline|Quitiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
654170|NCT00393978|P2|Participant Flow|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
654171|NCT00393978|P1|Participant Flow|Quitiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
654172|NCT00393978|O2|Outcome|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
654173|NCT00393978|O1|Outcome|Quitiapine and Placebo|"Quetiapine and Placebo~Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
654174|NCT00393978|O2|Outcome|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine and Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
654175|NCT00393978|O1|Outcome|Quitiapine and Placebo|"Quetiapine and Placebo~Quetiapine and placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
654176|NCT00393978|E2|Reported Event|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day)."
654177|NCT00393978|E1|Reported Event|Quitiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day)."
654178|NCT00393939|B3|Baseline|Total|Total of all reporting groups
654179|NCT00393939|B2|Baseline|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654180|NCT00393939|B1|Baseline|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654181|NCT00393939|P2|Participant Flow|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654182|NCT00393939|P1|Participant Flow|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654183|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654184|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654185|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654186|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654187|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654188|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654189|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654190|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654191|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654192|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654193|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654194|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654195|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654196|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654197|NCT00393939|E2|Reported Event|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
654237|NCT00393861|P1|Participant Flow|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
654198|NCT00393939|E1|Reported Event|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
654199|NCT00393913|B1|Baseline|Sleep Apnea Assessment|All participants were assigned to a single Arm (and received the intervention based on whether they had sleep apnea). Participants with sleep apnea used the CPAP machine for 4 to 6 weeks every night and then returned to the sleep laboratory for assessment of daytime function. Those without sleep apnea will have the initial assessment but then will not receive the intervention.
654200|NCT00393913|P1|Participant Flow|CPAP|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
654201|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
654202|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
654203|NCT00393913|O1|Outcome|Sleep Apnea|All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
654204|NCT00393913|E1|Reported Event|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
654205|NCT00393887|B3|Baseline|Total|Total of all reporting groups
654206|NCT00393887|B2|Baseline|Polypropylene Mesh|Synthetic polypropylene mesh
654207|NCT00393887|B1|Baseline|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
654208|NCT00393887|P2|Participant Flow|Polypropylene Mesh|Synthetic polypropylene mesh
654209|NCT00393887|P1|Participant Flow|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
654210|NCT00393887|O2|Outcome|Polypropylene Mesh|Inguinal hernia repair with Polypropylene mesh
654211|NCT00393887|O1|Outcome|Biodesign IHM Graft|Inguinal hernia repair with Biodesign Inguinal Hernia Matrix (IHM)
654212|NCT00393887|E2|Reported Event|Polypropylene Mesh|Synthetic polypropylene mesh
654213|NCT00393887|E1|Reported Event|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
654214|NCT00393874|B4|Baseline|Total|Total of all reporting groups
654215|NCT00393874|B3|Baseline|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
654216|NCT00393874|B2|Baseline|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
654217|NCT00393874|B1|Baseline|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
654218|NCT00393874|P3|Participant Flow|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
654219|NCT00393874|P2|Participant Flow|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
654238|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
654280|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654220|NCT00393874|P1|Participant Flow|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
654221|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medicat"
654222|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
654223|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal"
654224|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
654225|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
654226|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
654227|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
656797|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
654228|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
654229|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
654230|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
654231|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
654232|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
654233|NCT00393874|E3|Reported Event|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA took 4 capsules each night for eight weeks, all capsules were identical to prazosin capsules. They received a one-week medication."
654234|NCT00393874|E2|Reported Event|Behavioral|"Participants randomized to BSI received the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment was administered over 8 weeks. The intervention sessions consisted of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session was conducted on Week 5. Thirty-minute face-to-face contacts were scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that had occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
654235|NCT00393874|E1|Reported Event|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ took 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin was 10 mg. Some individuals required doses up to 15 mg."
654278|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654239|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
654240|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
654241|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
654242|NCT00393861|E1|Reported Event|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
654243|NCT00393848|B5|Baseline|Total|Total of all reporting groups
654244|NCT00393848|B4|Baseline|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
654245|NCT00393848|B3|Baseline|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
654246|NCT00393848|B2|Baseline|Experiment 1 - Standard of Care|Usual clinical care - no dietary intervention.
654247|NCT00393848|B1|Baseline|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
654248|NCT00393848|P4|Participant Flow|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
654249|NCT00393848|P3|Participant Flow|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
654250|NCT00393848|P2|Participant Flow|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
654251|NCT00393848|P1|Participant Flow|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
654252|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
654253|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
654254|NCT00393848|O4|Outcome|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
654255|NCT00393848|O3|Outcome|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
654256|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care without dietary intervention
654257|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
654258|NCT00393848|E4|Reported Event|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
654259|NCT00393848|E3|Reported Event|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
654260|NCT00393848|E2|Reported Event|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
654261|NCT00393848|E1|Reported Event|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
654262|NCT00393796|B3|Baseline|Total|Total of all reporting groups
654263|NCT00393796|B2|Baseline|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
654264|NCT00393796|B1|Baseline|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
654265|NCT00393796|P2|Participant Flow|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
654266|NCT00393796|P1|Participant Flow|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
654267|NCT00393796|O2|Outcome|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
654268|NCT00393796|O1|Outcome|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
654269|NCT00393796|E2|Reported Event|Placebo Only|"Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT."
654270|NCT00393796|E1|Reported Event|SUTENT|"Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT."
654271|NCT00393718|B3|Baseline|Total|Total of all reporting groups
654272|NCT00393718|B2|Baseline|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654273|NCT00393718|B1|Baseline|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654274|NCT00393718|P2|Participant Flow|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654275|NCT00393718|P1|Participant Flow|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654276|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654277|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654281|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654282|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654283|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654284|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654285|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654286|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654287|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654288|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654289|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654290|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654291|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654292|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654293|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654294|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654295|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654296|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654297|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654298|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654299|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654300|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654301|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654302|NCT00393718|E2|Reported Event|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
654303|NCT00393718|E1|Reported Event|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
654304|NCT00393705|B3|Baseline|Total|Total of all reporting groups
654305|NCT00393705|B2|Baseline|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654306|NCT00393705|B1|Baseline|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654307|NCT00393705|P2|Participant Flow|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654308|NCT00393705|P1|Participant Flow|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654309|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654310|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654311|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654312|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654313|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654314|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654332|NCT00393523|B5|Baseline|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
656798|NCT00386334|O1|Outcome|Placebo|Placebo tablets
654315|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654316|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654317|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654318|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654319|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654320|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654321|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654322|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654323|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654324|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654325|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654326|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654327|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654328|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654329|NCT00393705|E2|Reported Event|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
654330|NCT00393705|E1|Reported Event|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
654331|NCT00393523|B6|Baseline|Total|Total of all reporting groups
654439|NCT00393367|P1|Participant Flow|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
654333|NCT00393523|B4|Baseline|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654334|NCT00393523|B3|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654335|NCT00393523|B2|Baseline|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654336|NCT00393523|B1|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654337|NCT00393523|P5|Participant Flow|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
654338|NCT00393523|P4|Participant Flow|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654339|NCT00393523|P3|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654340|NCT00393523|P2|Participant Flow|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654341|NCT00393523|P1|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654342|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654343|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654344|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654345|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654346|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654347|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654348|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654349|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654350|NCT00393523|E5|Reported Event|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
654351|NCT00393523|E4|Reported Event|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654352|NCT00393523|E3|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654440|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
656799|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
654353|NCT00393523|E2|Reported Event|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
654354|NCT00393523|E1|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
654355|NCT00393510|B3|Baseline|Total|Total of all reporting groups
654356|NCT00393510|B2|Baseline|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
654357|NCT00393510|B1|Baseline|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
654358|NCT00393510|P2|Participant Flow|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
654359|NCT00393510|P1|Participant Flow|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
654360|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
654361|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
654362|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
654363|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
654364|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
654365|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
654366|NCT00393510|E2|Reported Event|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
654367|NCT00393510|E1|Reported Event|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
654368|NCT00393484|B3|Baseline|Total|Total of all reporting groups
654369|NCT00393484|B2|Baseline|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654370|NCT00393484|B1|Baseline|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654371|NCT00393484|P2|Participant Flow|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654372|NCT00393484|P1|Participant Flow|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654373|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654374|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654375|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654376|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654377|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654378|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654379|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654380|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654381|NCT00393484|O2|Outcome|Lamivudine, 100 mg|Participants received lamivudine, 100 mg, once daily for up to 240 weeks
654382|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654521|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
654383|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654384|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654385|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654386|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654387|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654388|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654389|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654390|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654391|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654392|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654393|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654394|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654395|NCT00393484|O2|Outcome|Lamivudine, 100 mg+ Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654396|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654397|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654398|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654399|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654400|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654401|NCT00393484|E2|Reported Event|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654402|NCT00393484|E1|Reported Event|Entecavir , 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
654403|NCT00393458|B5|Baseline|Total|Total of all reporting groups
654404|NCT00393458|B4|Baseline|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654405|NCT00393458|B3|Baseline|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654406|NCT00393458|B2|Baseline|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654407|NCT00393458|B1|Baseline|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654408|NCT00393458|P4|Participant Flow|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654409|NCT00393458|P3|Participant Flow|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654410|NCT00393458|P2|Participant Flow|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654411|NCT00393458|P1|Participant Flow|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654412|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654413|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654414|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654415|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654522|NCT00393042|O6|Outcome|Focalin XR - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
654416|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654417|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654418|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654419|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654420|NCT00393458|E4|Reported Event|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654421|NCT00393458|E3|Reported Event|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654422|NCT00393458|E2|Reported Event|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654423|NCT00393458|E1|Reported Event|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
654424|NCT00393380|B1|Baseline|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654425|NCT00393380|P1|Participant Flow|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654426|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654427|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654428|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654429|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654430|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654431|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654432|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654433|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654434|NCT00393380|E1|Reported Event|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
654435|NCT00393367|B3|Baseline|Total|Total of all reporting groups
654436|NCT00393367|B2|Baseline|Placebo (Saline)|standardized treatment with nebulized saline
654437|NCT00393367|B1|Baseline|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
654438|NCT00393367|P2|Participant Flow|Placebo (Saline)|standardized treatment with nebulized saline
656800|NCT00386334|O1|Outcome|Placebo|Placebo tablets
654441|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
654442|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654443|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654444|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654445|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654446|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654447|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654448|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654449|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654450|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654451|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654452|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654453|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654454|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654455|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654456|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654457|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654458|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654459|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654460|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
654461|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
654462|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
654463|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
654464|NCT00393367|E2|Reported Event|Placebo (Saline)|standardized treatment with nebulized saline
654465|NCT00393367|E1|Reported Event|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
654466|NCT00393094|B1|Baseline|Enrollment Until Prior to Treatment|
654467|NCT00393094|P1|Participant Flow|Enrollment Until Prior to Treatment|
654468|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Glioblastoma Multiforme: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Glioblastoma multiforme- is a fast growing type of central nervous system tumor that forms from glial (supportive) tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma multiforme usually occurs in adults and affects the brain more often than the spinal cord. Also called GBM, glioblastoma, and grade IV astrocytoma.
654469|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Anaplastic Glioma Pts: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Anaplastic gliomas are classified by the World Health Organization (WHO) as grade 3 malignant tumors and include the anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma or mixed glioma.
654470|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
654471|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
654472|NCT00393094|E1|Reported Event|Enrollment Until Prior to Treatment|
654473|NCT00393068|B1|Baseline|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
654474|NCT00393068|P1|Participant Flow|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
654475|NCT00393068|O1|Outcome|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
654476|NCT00393068|E1|Reported Event|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
654523|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the placebo dosage week for the Focalin XR medication.
654524|NCT00393042|O4|Outcome|Adderall XR - 25/30mg|This is the 25/30 mg dosage week for the Adderall XR medication.
654525|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
654526|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
654477|NCT00393042|B1|Baseline|Overall Study|Participants either Adderall XR or Focalin XR for four weeks (3 dose levels and placebo) followed by four weeks (3 dose levels and placebo) of the opposite medication they received the first four weeks. Baseline Measures are based off all participants that were randomized regardless of the order they received the medication. Since we were interested in evaluating efficacy and adverse events at all dose conditions, participants were included in analysis if they received at least 2 weeks of study drug to insure that all participants had been exposed to at least one week of active drug
654478|NCT00393042|P2|Participant Flow|Adderall XR Then Focalin XR|Adderall XR first for 4 weeks (3 dose levels and placebo) then Focalin XR for 4 weeks (3 dose levels and placebo).
654479|NCT00393042|P1|Participant Flow|Focalin XR Then Adderall XR|Focalin XR first for 4 weeks (3 dose levels and placebo) then Adderall XR for 4 weeks (3 dose levels and placebo).
654480|NCT00393042|O8|Outcome|Focalin XR - 25/30mg|This is the 25/30 mg dosage week for the Focalin XR medication.
654481|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
654482|NCT00393042|O6|Outcome|Focalin XR - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
654483|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the Placebo dosage week for the Focalin XR medication.
654484|NCT00393042|O4|Outcome|Adderall XR - 25/30mg|This is the 25/30 mg dosage week for the Adderall XR medication.
654485|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
654486|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
654487|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
654488|NCT00393042|O8|Outcome|Focalin XR - 25/30 mg|This is the 25/30 mg dosage week for the Focalin XR medication.
654489|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
654490|NCT00393042|O6|Outcome|Focalin - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
654491|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the placebo dosage week for the Focalin XR medication.
654492|NCT00393042|O4|Outcome|Adderall XR - 25/30 mg|This is the 25/30 mg dosage week for the Adderall XR medication.
654493|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
654494|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
654495|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
654496|NCT00393042|O24|Outcome|10/10 Allele: 25/30mg of Focaling XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
654497|NCT00393042|O23|Outcome|10/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
654498|NCT00393042|O22|Outcome|10/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
654499|NCT00393042|O21|Outcome|10/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele
654500|NCT00393042|O20|Outcome|10/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
654501|NCT00393042|O19|Outcome|10/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
654502|NCT00393042|O18|Outcome|10/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
654503|NCT00393042|O17|Outcome|10/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele
654504|NCT00393042|O16|Outcome|9/10 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
654505|NCT00393042|O15|Outcome|9/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
654506|NCT00393042|O14|Outcome|9/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
654507|NCT00393042|O13|Outcome|9/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele
654508|NCT00393042|O12|Outcome|9/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
654509|NCT00393042|O11|Outcome|9/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
654510|NCT00393042|O10|Outcome|9/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
654511|NCT00393042|O9|Outcome|9/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele
654512|NCT00393042|O8|Outcome|9/9 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
654513|NCT00393042|O7|Outcome|9/9 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
654514|NCT00393042|O6|Outcome|9/9 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
654515|NCT00393042|O5|Outcome|9/9 Allele: Placebo of Focalin XR|This is the placebo dosage of Focalin XR medication phase for the participants with the 9/9 allele
654516|NCT00393042|O4|Outcome|9/9 Allele: 25/30mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
654517|NCT00393042|O3|Outcome|9/9 Allele: 20 mg Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
654518|NCT00393042|O2|Outcome|9/9 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
654519|NCT00393042|O1|Outcome|9/9 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/9 allele
654520|NCT00393042|O8|Outcome|Focalin XR - 25/30mg|This is the 25/30 mg dosage week for the Focalin XR medication.
654527|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
654528|NCT00393042|O6|Outcome|Focalin XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
654529|NCT00393042|O5|Outcome|Adderall XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
654530|NCT00393042|O4|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25/30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
654531|NCT00393042|O3|Outcome|20 mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
654532|NCT00393042|O2|Outcome|10mg of Either Focalin XR or Adderall XR|Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
654533|NCT00393042|O1|Outcome|Placebo|Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
654534|NCT00393042|O6|Outcome|Focalin XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
654535|NCT00393042|O5|Outcome|Adderall XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
654536|NCT00393042|O4|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
654537|NCT00393042|O3|Outcome|20mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
654538|NCT00393042|O2|Outcome|10mg of Either Focalin XR or Adderall XR|Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
654539|NCT00393042|O1|Outcome|Placebo|Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
654540|NCT00393042|E8|Reported Event|25/30mg of Adderall XR|Each participant recieved 25/30 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
654541|NCT00393042|E7|Reported Event|20 mg of Adderall XR|Each participant recieved 20 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
654542|NCT00393042|E6|Reported Event|10mg of Adderall XR|Each participant recieved 10 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
654543|NCT00393042|E5|Reported Event|Placebo of Adderall XR|Each participant recieved placebo of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
654544|NCT00393042|E4|Reported Event|25/30mg of Focalin XR|Each participant recieved 25/30 mg (depending on weight) of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
654545|NCT00393042|E3|Reported Event|20 mg of Focalin XR|Each participant recieved 20 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
654546|NCT00393042|E2|Reported Event|10mg of Focalin XR|Each participant recieved 10 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
654547|NCT00393042|E1|Reported Event|Placebo of Focalin XR|Each participant recieved placebo of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
654548|NCT00393029|B3|Baseline|Total|Total of all reporting groups
654549|NCT00393029|B2|Baseline|Other Metastatic Cancers|
654550|NCT00393029|B1|Baseline|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
654551|NCT00393029|P2|Participant Flow|Other Metastatic Cancers|
654552|NCT00393029|P1|Participant Flow|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
654553|NCT00393029|O2|Outcome|Other Metastatic Cancers|
654554|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
654555|NCT00393029|O2|Outcome|Other Metastatic Cancers|
654556|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
654557|NCT00393029|O1|Outcome|Metastatic Melanoma & Other Metastatic Cancers|"Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).~There are no statistical differences between the arms, therefore, they can be combined for this outcome measure."
654558|NCT00393029|E2|Reported Event|Other Metastatic Cancers|
654559|NCT00393029|E1|Reported Event|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
654560|NCT00392951|B1|Baseline|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654561|NCT00392951|P1|Participant Flow|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654562|NCT00392951|O1|Outcome|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654955|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654563|NCT00392951|O1|Outcome|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654564|NCT00392951|O1|Outcome|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654565|NCT00392951|O1|Outcome|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654566|NCT00392951|O1|Outcome|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654567|NCT00392951|E1|Reported Event|Sirolimus Treatment|"Sirolimus treatment~sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)"
654568|NCT00392925|B5|Baseline|Total|Total of all reporting groups
654569|NCT00392925|B4|Baseline|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
654570|NCT00392925|B3|Baseline|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654571|NCT00392925|B2|Baseline|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654572|NCT00392925|B1|Baseline|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654573|NCT00392925|P4|Participant Flow|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654574|NCT00392925|P3|Participant Flow|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654575|NCT00392925|P2|Participant Flow|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 milligram (mg) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654576|NCT00392925|P1|Participant Flow|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
654577|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654578|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654579|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654580|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654581|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654582|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654602|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654603|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654583|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
654584|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654585|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654586|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654587|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
654588|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654589|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654590|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654591|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
654592|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654593|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654594|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654595|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
654596|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654597|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654598|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654599|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654600|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654601|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654604|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654605|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654606|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654607|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654608|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654609|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654610|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654611|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654612|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654613|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654614|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654615|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654616|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654617|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654618|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654619|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654620|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654621|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654622|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654623|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654624|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654625|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654626|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654627|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654956|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654628|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654629|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654630|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654631|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654632|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654633|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654634|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654635|NCT00392925|O1|Outcome|Lead-In Participants Randomized to Treatment on Day 1|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to a treatment group.
654636|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654637|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654638|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654639|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654640|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654641|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654642|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654643|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654644|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654645|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654646|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654647|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654648|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654649|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654650|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654698|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
654651|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654652|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654653|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654654|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654655|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654656|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654657|NCT00392925|E4|Reported Event|Participants Not Randomized to Group After Lead-In Period|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
654658|NCT00392925|E3|Reported Event|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654659|NCT00392925|E2|Reported Event|Pramlintide + Placebo|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654660|NCT00392925|E1|Reported Event|Placebo + Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
654661|NCT00392860|B3|Baseline|Total|Total of all reporting groups
654662|NCT00392860|B2|Baseline|Control Group|Participants will be given a new standard handrim.
654663|NCT00392860|B1|Baseline|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
654664|NCT00392860|P3|Participant Flow|Handrim Control Group|Participants will be given a new standard handrim.
654665|NCT00392860|P2|Participant Flow|PalmRim Experiment|"Participants will have a PalmRim handrim installed on their wheelchair. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.~Participants were to use the PalmRim handrim for a four month trial period, before returning for follow up evaluations."
654666|NCT00392860|P1|Participant Flow|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair. The Natural-Fit device was designed to directly address the shortcomings of standard handrims and to improve the standard round-tube handrims which were designed over 50 years ago.~Participants used the Natural-Fit Handrim for a four month trial period, before returning for follow up evaluations.~Natural-Fit : Ergonomic handrim for wheelchairs"
654667|NCT00392860|O2|Outcome|Handrim Control Group|Participants will be given a new standard handrim.
654668|NCT00392860|O1|Outcome|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
654669|NCT00392860|E2|Reported Event|Control Group|Participants will be given a new standard handrim.
654670|NCT00392860|E1|Reported Event|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
654671|NCT00392834|B3|Baseline|Total|Total of all reporting groups
654672|NCT00392834|B2|Baseline|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
654673|NCT00392834|B1|Baseline|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
654699|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
654700|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
654674|NCT00392834|P2|Participant Flow|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
654675|NCT00392834|P1|Participant Flow|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
654676|NCT00392834|O2|Outcome|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
654677|NCT00392834|O1|Outcome|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
654678|NCT00392834|E2|Reported Event|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
654679|NCT00392834|E1|Reported Event|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
654680|NCT00392821|B1|Baseline|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
654681|NCT00392821|P1|Participant Flow|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
654682|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
654683|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
654684|NCT00392821|E1|Reported Event|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
654685|NCT00392808|B5|Baseline|Total|Total of all reporting groups
654686|NCT00392808|B4|Baseline|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
654687|NCT00392808|B3|Baseline|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
654688|NCT00392808|B2|Baseline|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
654689|NCT00392808|B1|Baseline|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
654690|NCT00392808|P4|Participant Flow|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
654691|NCT00392808|P3|Participant Flow|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
654692|NCT00392808|P2|Participant Flow|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
654693|NCT00392808|P1|Participant Flow|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
654694|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
654695|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
654696|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
654697|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
654701|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
654702|NCT00392808|E4|Reported Event|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
654703|NCT00392808|E3|Reported Event|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
654704|NCT00392808|E2|Reported Event|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
654705|NCT00392808|E1|Reported Event|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
654706|NCT00392782|B1|Baseline|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654707|NCT00392782|P1|Participant Flow|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654708|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654709|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654710|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654711|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654712|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654713|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654714|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654715|NCT00392782|E1|Reported Event|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
654716|NCT00392769|B1|Baseline|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
654717|NCT00392769|P1|Participant Flow|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
654718|NCT00392769|O1|Outcome|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
654719|NCT00392769|E1|Reported Event|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
654720|NCT00392704|B1|Baseline|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
654772|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
656801|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
654721|NCT00392704|P1|Participant Flow|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
654722|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
654723|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
654724|NCT00392704|E1|Reported Event|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
654725|NCT00392678|B5|Baseline|Total|Total of all reporting groups
654726|NCT00392678|B4|Baseline|Placebo|
654727|NCT00392678|B3|Baseline|Salsalate 4.0 g/d|
654728|NCT00392678|B2|Baseline|Salsalate 3.5 g/d|
654729|NCT00392678|B1|Baseline|Salsalate 3.0 g/d|
654730|NCT00392678|P4|Participant Flow|Placebo|
654731|NCT00392678|P3|Participant Flow|Salsalate 4.0 g/d|
654732|NCT00392678|P2|Participant Flow|Salsalate 3.5 g/d|
654733|NCT00392678|P1|Participant Flow|Salsalate 3.0 g/d|
654734|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
654735|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
654736|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
654737|NCT00392678|O1|Outcome|Placebo|Placebo
654738|NCT00392678|O4|Outcome|Placebo|Placebo
654739|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
654740|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
654741|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
654742|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
654743|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
654744|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
654745|NCT00392678|O1|Outcome|Placebo|Placebo
654746|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
654747|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
654748|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
654749|NCT00392678|O1|Outcome|Placebo|Placebo
654750|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
654751|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
654752|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
654753|NCT00392678|O1|Outcome|Placebo|Placebo
654754|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
654755|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
654756|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
654757|NCT00392678|O1|Outcome|Placebo|Placebo
654758|NCT00392678|O4|Outcome|Placebo|Placebo
654759|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
654760|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
654761|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
654762|NCT00392678|E4|Reported Event|Placebo|
654763|NCT00392678|E3|Reported Event|Salsalate 4.0 g/d|
654764|NCT00392678|E2|Reported Event|Salsalate 3.5 g/d|
654765|NCT00392678|E1|Reported Event|Salsalate 3.0 g/d|
654766|NCT00392665|B3|Baseline|Total|Total of all reporting groups
654767|NCT00392665|B2|Baseline|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
654768|NCT00392665|B1|Baseline|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
654769|NCT00392665|P2|Participant Flow|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
654770|NCT00392665|P1|Participant Flow|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
654771|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
654773|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
654774|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
654775|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
654776|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
654777|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
654778|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
654779|NCT00392665|E2|Reported Event|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
654780|NCT00392665|E1|Reported Event|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
654781|NCT00392496|B1|Baseline|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
654782|NCT00392496|P1|Participant Flow|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
654783|NCT00392496|O1|Outcome|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
654784|NCT00392496|E1|Reported Event|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
654785|NCT00392444|B1|Baseline|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
654786|NCT00392444|P1|Participant Flow|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
654787|NCT00392444|O1|Outcome|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
654788|NCT00392444|E1|Reported Event|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
654789|NCT00392392|B1|Baseline|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
654790|NCT00392392|P1|Participant Flow|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
654791|NCT00392392|O1|Outcome|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
654792|NCT00392392|E1|Reported Event|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
654793|NCT00392379|B3|Baseline|Total|Total of all reporting groups
654794|NCT00392379|B2|Baseline|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654795|NCT00392379|B1|Baseline|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654821|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
654822|NCT00392288|E3|Reported Event|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
656802|NCT00386334|O1|Outcome|Placebo|Placebo tablets
654796|NCT00392379|P2|Participant Flow|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654797|NCT00392379|P1|Participant Flow|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654798|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654799|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654800|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654801|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654802|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654803|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654804|NCT00392379|E2|Reported Event|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654805|NCT00392379|E1|Reported Event|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
654806|NCT00392288|B4|Baseline|Total|Total of all reporting groups
654807|NCT00392288|B3|Baseline|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
654808|NCT00392288|B2|Baseline|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
654809|NCT00392288|B1|Baseline|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
654810|NCT00392288|P3|Participant Flow|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
654811|NCT00392288|P2|Participant Flow|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
654812|NCT00392288|P1|Participant Flow|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
654813|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
654814|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
654815|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
654816|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
654817|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
654818|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
654819|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
654820|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
654823|NCT00392288|E2|Reported Event|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
654824|NCT00392288|E1|Reported Event|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
654825|NCT00392236|B3|Baseline|Total|Total of all reporting groups
654826|NCT00392236|B2|Baseline|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
654827|NCT00392236|B1|Baseline|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
654828|NCT00392236|P2|Participant Flow|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual means that study participation does not affect the treatment participants receive in any way. Participants receive whatever treatment they and the clinical team decide upon."
654829|NCT00392236|P1|Participant Flow|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
654830|NCT00392236|O2|Outcome|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
654831|NCT00392236|O1|Outcome|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
654832|NCT00392236|E2|Reported Event|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
654833|NCT00392236|E1|Reported Event|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
654834|NCT00392223|B3|Baseline|Total|Total of all reporting groups
654835|NCT00392223|B2|Baseline|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654836|NCT00392223|B1|Baseline|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654837|NCT00392223|P2|Participant Flow|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654838|NCT00392223|P1|Participant Flow|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654839|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654840|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654841|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654842|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654843|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654844|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654845|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654846|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654847|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654848|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654849|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654850|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654851|NCT00392223|E2|Reported Event|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
654852|NCT00392223|E1|Reported Event|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
654853|NCT00392210|B3|Baseline|Total|Total of all reporting groups
654854|NCT00392210|B2|Baseline|Back Fill Followed by Auto Fill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
654855|NCT00392210|B1|Baseline|Auto Fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
654856|NCT00392210|P2|Participant Flow|Back Fill Followed by Autofill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
654857|NCT00392210|P1|Participant Flow|Auto-fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
654858|NCT00392210|O2|Outcome|Back Fill Intervention|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
654859|NCT00392210|O1|Outcome|Auto Fill Intervention|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
654860|NCT00392210|E2|Reported Event|Back Fill|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
654861|NCT00392210|E1|Reported Event|Auto Fill|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
654862|NCT00392197|B3|Baseline|Total|Total of all reporting groups
654863|NCT00392197|B2|Baseline|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
654864|NCT00392197|B1|Baseline|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
654865|NCT00392197|P2|Participant Flow|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
654866|NCT00392197|P1|Participant Flow|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
654867|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
654868|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
654869|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
654870|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
654871|NCT00392197|E2|Reported Event|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
654872|NCT00392197|E1|Reported Event|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
654873|NCT00392171|B1|Baseline|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
654874|NCT00392171|P1|Participant Flow|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
654875|NCT00392171|O1|Outcome|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
654876|NCT00392171|E1|Reported Event|Temozolomide|
654877|NCT00391989|B1|Baseline|Dasatinib|All patients registered in the study.
654878|NCT00391989|P1|Participant Flow|Study Group|All patients registered in the study.
654879|NCT00391989|O1|Outcome|Study Group|All patients registered in the study.
654880|NCT00391989|E1|Reported Event|Dasatinib|All patients registered in the study.
654881|NCT00391976|B4|Baseline|Total|Total of all reporting groups
654882|NCT00391976|B3|Baseline|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
654883|NCT00391976|B2|Baseline|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654884|NCT00391976|B1|Baseline|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654885|NCT00391976|P3|Participant Flow|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
654886|NCT00391976|P2|Participant Flow|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654887|NCT00391976|P1|Participant Flow|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654888|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
654951|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654952|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654889|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654890|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654891|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
654892|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654893|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654894|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
654895|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654896|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654897|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
654898|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654899|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654900|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
654901|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654902|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654903|NCT00391976|E5|Reported Event|Tobramycin 56 Days After Month 3|Patients received tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
654904|NCT00391976|E4|Reported Event|Tobramycin 28 Days After Month 3|Patients who received tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
654905|NCT00391976|E3|Reported Event|Non-randomized Patients up to Month 3|Patients who started the study and received tobramycin 300 mg twice a day for 28 days but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups.
654906|NCT00391976|E2|Reported Event|Tobramycin 56 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654907|NCT00391976|E1|Reported Event|Tobramycin 28 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
654908|NCT00391898|B3|Baseline|Total|Total of all reporting groups
654909|NCT00391898|B2|Baseline|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654910|NCT00391898|B1|Baseline|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654911|NCT00391898|P2|Participant Flow|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654912|NCT00391898|P1|Participant Flow|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654953|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654954|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
656803|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
654913|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654914|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654915|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654916|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654917|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654918|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654919|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654920|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654921|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654922|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654923|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654924|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654925|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654926|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654927|NCT00391898|E2|Reported Event|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
654928|NCT00391898|E1|Reported Event|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
654929|NCT00391872|B3|Baseline|Total|Total of all reporting groups
654930|NCT00391872|B2|Baseline|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654931|NCT00391872|B1|Baseline|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654932|NCT00391872|P2|Participant Flow|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654933|NCT00391872|P1|Participant Flow|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654934|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654935|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654936|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654937|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654938|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654939|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654940|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654941|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654942|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654943|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654944|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654945|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654946|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654947|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654948|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654949|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654950|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654957|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654958|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654959|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654960|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654961|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654962|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654963|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654964|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654965|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654966|NCT00391872|E2|Reported Event|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
654967|NCT00391872|E1|Reported Event|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
654968|NCT00391846|B3|Baseline|Total|Total of all reporting groups
654969|NCT00391846|B2|Baseline|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654970|NCT00391846|B1|Baseline|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654971|NCT00391846|P2|Participant Flow|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654972|NCT00391846|P1|Participant Flow|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654973|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654974|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654975|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654976|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654977|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654978|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654979|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654980|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654981|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654982|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654983|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654984|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654985|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654986|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654987|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654988|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654989|NCT00391846|E2|Reported Event|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
654990|NCT00391846|E1|Reported Event|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
654991|NCT00391807|B1|Baseline|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654992|NCT00391807|P1|Participant Flow|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654993|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654994|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654995|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654996|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654997|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654998|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
654999|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655000|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655001|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655002|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655003|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655004|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655005|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655006|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655007|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655008|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655009|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655010|NCT00391807|E1|Reported Event|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
655011|NCT00391768|B8|Baseline|Total|Total of all reporting groups
655012|NCT00391768|B7|Baseline|Cohort V|0 to 2 months of age, 3 mg/kg body weight
655013|NCT00391768|B6|Baseline|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
655014|NCT00391768|B5|Baseline|Cohort III|6 to 8 months of age, 3 mg/kg body weight
655015|NCT00391768|B4|Baseline|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
655016|NCT00391768|B3|Baseline|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
655017|NCT00391768|B2|Baseline|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
655018|NCT00391768|B1|Baseline|Cohort IA|12 - 23 months of age, 30 mg
655019|NCT00391768|P7|Participant Flow|Cohort V|0 to 2 months of age, 3 mg/kg body weight
655020|NCT00391768|P6|Participant Flow|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
655021|NCT00391768|P5|Participant Flow|Cohort III|6 to 8 months of age, 3 mg/kg body weight
655022|NCT00391768|P4|Participant Flow|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
655023|NCT00391768|P3|Participant Flow|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
655024|NCT00391768|P2|Participant Flow|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
655025|NCT00391768|P1|Participant Flow|Cohort IA|12 - 23 months of age, 30 mg
655026|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
655027|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
655028|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
655029|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
655030|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
655031|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
655032|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
655033|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655034|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655035|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655036|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655037|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655038|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
655039|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
655040|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
655041|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
655042|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
655043|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
655044|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
655045|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
655046|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
655047|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
655048|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
655049|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
655050|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
655051|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
655052|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
655053|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
655054|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
655055|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
655056|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
655057|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
655058|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
655059|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
655060|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
655061|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
655062|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
655063|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
655064|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
655065|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
655066|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days
655067|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days
655068|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
655069|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
655070|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
655071|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
655072|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
655073|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
655074|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days.
655075|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655076|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655077|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655078|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655079|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
655080|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
655081|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
655082|NCT00391768|E7|Reported Event|Cohort V|0 to 2 months of age, 3 mg/kg body weight
655083|NCT00391768|E6|Reported Event|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
655084|NCT00391768|E5|Reported Event|Cohort III|6 to 8 months of age, 3 mg/kg body weight
655085|NCT00391768|E4|Reported Event|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
655086|NCT00391768|E3|Reported Event|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
655087|NCT00391768|E2|Reported Event|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
655088|NCT00391768|E1|Reported Event|Cohort IA|12 - 23 months of age, 30 mg
655089|NCT00391716|B4|Baseline|Total|Total of all reporting groups
655090|NCT00391716|B3|Baseline|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
655091|NCT00391716|B2|Baseline|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
655092|NCT00391716|B1|Baseline|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
655093|NCT00391716|P3|Participant Flow|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
655094|NCT00391716|P2|Participant Flow|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
655120|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
655095|NCT00391716|P1|Participant Flow|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
655096|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
655097|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
655098|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
655099|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
655100|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
655101|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
655102|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
655103|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
655104|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
655105|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
655106|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
655107|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
655108|NCT00391716|E3|Reported Event|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
655109|NCT00391716|E2|Reported Event|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
655110|NCT00391716|E1|Reported Event|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
655111|NCT00391625|B1|Baseline|GA-GCB|15-60 U/kg every other week via intravenous infusion
655112|NCT00391625|P1|Participant Flow|GA-GCB|15-60 U/kg every other week via intravenous infusion
655113|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
655114|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
655115|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
655116|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
655117|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
655118|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
655119|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
656804|NCT00386334|O1|Outcome|Placebo|Placebo tablets
655121|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
655122|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
655123|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
655124|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
655125|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
655126|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
655127|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
655128|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
655129|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
655130|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
655131|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
655132|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
655133|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
655134|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
655135|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
655136|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
655137|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
655138|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
655139|NCT00391625|O11|Outcome|# Deaths|
655140|NCT00391625|O10|Outcome|# Discontinued Due to an AE|15-60 U/kg, every other week Intravenously
655141|NCT00391625|O9|Outcome|# Experienced at Least 1 Drug-related Serious AE|15-60 U/kg, every other week Intravenously
655142|NCT00391625|O8|Outcome|# Experienced at Least 1 Serious AE|15-60 U/kg, every other week Intravenously
655143|NCT00391625|O7|Outcome|# Experienced at Least 1 Life-threatening AE|15-60 U/kg, every other week Intravenously
655144|NCT00391625|O6|Outcome|# Experienced at Least 1 Drug-related Severe AE|15-60 U/kg, every other week Intravenously
655145|NCT00391625|O5|Outcome|# Experienced at Least 1 Severe AE|15-60 U/kg, every other week Intravenously
655146|NCT00391625|O4|Outcome|# Experienced at Least 1 Infusion-related AE|15-60 U/kg, every other week Intravenously
655147|NCT00391625|O3|Outcome|# Experienced at Least 1 Drug-related AE|15-60 U/kg, every other week Intravenously
655148|NCT00391625|O2|Outcome|# Experienced at Least 1 AE|15-60 U/kg, every other week Intravenously
655149|NCT00391625|O1|Outcome|Number (#) Experienced no Adverse Event (AE)|15-60 U/kg every other week via intravenous infusion
655150|NCT00391625|E1|Reported Event|GA-GCB|
655151|NCT00391599|B3|Baseline|Total|Total of all reporting groups
655152|NCT00391599|B2|Baseline|Control Group|no preoperative intestinal preparation.
655153|NCT00391599|B1|Baseline|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
655154|NCT00391599|P2|Participant Flow|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
655155|NCT00391599|P1|Participant Flow|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
655156|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
655157|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
655158|NCT00391599|O2|Outcome|Control Group|"no preoperative intestinal preparation.~enema"
655159|NCT00391599|O1|Outcome|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
655160|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
655161|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
655162|NCT00391599|E2|Reported Event|Control Group|"no preoperative intestinal preparation.~the night before cesarean section"
655163|NCT00391599|E1|Reported Event|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema~the night before cesarean section"
655164|NCT00391586|B1|Baseline|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
655165|NCT00391586|P1|Participant Flow|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
655166|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
655167|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
655168|NCT00391586|E1|Reported Event|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
655169|NCT00391469|B5|Baseline|Total|Total of all reporting groups
655201|NCT00391391|B1|Baseline|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655170|NCT00391469|B4|Baseline|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655171|NCT00391469|B3|Baseline|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
655172|NCT00391469|B2|Baseline|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655173|NCT00391469|B1|Baseline|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
655174|NCT00391469|P2|Participant Flow|Control|standard of care
655175|NCT00391469|P1|Participant Flow|Intervention|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655176|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655177|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
655178|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655179|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
655180|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655181|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
655182|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655183|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
655184|NCT00391469|E2|Reported Event|Control-standard Care|standard care
655185|NCT00391469|E1|Reported Event|Intervention-hypo|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
655186|NCT00391443|B3|Baseline|Total|Total of all reporting groups
655187|NCT00391443|B2|Baseline|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655188|NCT00391443|B1|Baseline|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655189|NCT00391443|P2|Participant Flow|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655190|NCT00391443|P1|Participant Flow|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655191|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655192|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655193|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655194|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655195|NCT00391443|E2|Reported Event|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655196|NCT00391443|E1|Reported Event|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
655197|NCT00391391|B5|Baseline|Total|Total of all reporting groups
655198|NCT00391391|B4|Baseline|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655199|NCT00391391|B3|Baseline|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655200|NCT00391391|B2|Baseline|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655279|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655202|NCT00391391|P4|Participant Flow|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655203|NCT00391391|P3|Participant Flow|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655204|NCT00391391|P2|Participant Flow|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655205|NCT00391391|P1|Participant Flow|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655206|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655207|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655208|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655209|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655210|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655211|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655212|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655213|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655214|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655215|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655216|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655217|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655218|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655219|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655220|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655221|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655222|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655223|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655224|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655225|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655226|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655227|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655228|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655229|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655230|NCT00391391|E4|Reported Event|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
655231|NCT00391391|E3|Reported Event|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
655232|NCT00391391|E2|Reported Event|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
655233|NCT00391391|E1|Reported Event|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
655234|NCT00391365|B3|Baseline|Total|Total of all reporting groups
655235|NCT00391365|B2|Baseline|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
655236|NCT00391365|B1|Baseline|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
655237|NCT00391365|P2|Participant Flow|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
655277|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655238|NCT00391365|P1|Participant Flow|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
655239|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
655240|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
655241|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
655242|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
655243|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
655244|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
655245|NCT00391365|E2|Reported Event|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
655246|NCT00391365|E1|Reported Event|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
655247|NCT00391274|B3|Baseline|Total|Total of all reporting groups
655248|NCT00391274|B2|Baseline|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655249|NCT00391274|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655250|NCT00391274|P2|Participant Flow|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655251|NCT00391274|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655252|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655253|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655254|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655255|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655256|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655257|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655258|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655259|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655260|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655261|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655262|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655263|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655264|NCT00391274|E2|Reported Event|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
655265|NCT00391274|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
655266|NCT00391222|B4|Baseline|Total|Total of all reporting groups
655267|NCT00391222|B3|Baseline|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day
655268|NCT00391222|B2|Baseline|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655269|NCT00391222|B1|Baseline|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily
655270|NCT00391222|P4|Participant Flow|Open-label Risperidone LAI|Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days
655271|NCT00391222|P3|Participant Flow|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655272|NCT00391222|P2|Participant Flow|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655273|NCT00391222|P1|Participant Flow|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655274|NCT00391222|O1|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655275|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655276|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655278|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655280|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655281|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655282|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655283|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655284|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655285|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655286|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655287|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655288|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655289|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655290|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655291|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655292|NCT00391222|E4|Reported Event|Open-label Risperidone LAI|risperidone 25, 37.5, or 50 mg intramuscular every 14 days
655293|NCT00391222|E3|Reported Event|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
655294|NCT00391222|E2|Reported Event|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
655295|NCT00391222|E1|Reported Event|Risperidone LAI|Double-blind Period III: risperidone LAI 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
655296|NCT00391092|B3|Baseline|Total|Total of all reporting groups
655297|NCT00391092|B2|Baseline|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655298|NCT00391092|B1|Baseline|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655299|NCT00391092|P2|Participant Flow|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655300|NCT00391092|P1|Participant Flow|Trastuzumab + Docetaxel|Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655301|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655302|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655303|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655304|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655305|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655328|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
655363|NCT00391053|E4|Reported Event|Standad Dose Inactivated, Split-Virion Influenza Vaccine|
655306|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655307|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655308|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655309|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655310|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655311|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655312|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655313|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655314|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655315|NCT00391092|E2|Reported Event|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
655316|NCT00391092|E1|Reported Event|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
655317|NCT00391079|B3|Baseline|Total|Total of all reporting groups
655318|NCT00391079|B2|Baseline|Placebo|Range of 8-12 sprays per day of placebo spray.
655319|NCT00391079|B1|Baseline|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655320|NCT00391079|P2|Participant Flow|Placebo|Range of 8-12 sprays per day of placebo spray.
655321|NCT00391079|P1|Participant Flow|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655322|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
655323|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655324|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
655325|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655326|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
655327|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655329|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655330|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
655331|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655332|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
655333|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655334|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
655335|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655336|NCT00391079|E2|Reported Event|Placebo|Range of 8-12 sprays of placebo per day
655337|NCT00391079|E1|Reported Event|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
655338|NCT00391053|B5|Baseline|Total|Total of all reporting groups
655339|NCT00391053|B4|Baseline|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
655340|NCT00391053|B3|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
655341|NCT00391053|B2|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
655342|NCT00391053|B1|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
655343|NCT00391053|P4|Participant Flow|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
655344|NCT00391053|P3|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
655345|NCT00391053|P2|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
655346|NCT00391053|P1|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
655347|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
655348|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
655349|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
655350|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
655351|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
655352|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
655353|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
655354|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
655355|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
655356|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
655357|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
655358|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
655359|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
655360|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
655361|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
655362|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
655364|NCT00391053|E3|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|
655365|NCT00391053|E2|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|
655366|NCT00391053|E1|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|
655367|NCT00391027|B3|Baseline|Total|Total of all reporting groups
655368|NCT00391027|B2|Baseline|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655369|NCT00391027|B1|Baseline|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655370|NCT00391027|P2|Participant Flow|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655371|NCT00391027|P1|Participant Flow|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655372|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655373|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655374|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655375|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655376|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655377|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655378|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655379|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655380|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655381|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655382|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655383|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655384|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655385|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655386|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655387|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655388|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655389|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655390|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655391|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655426|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655392|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655393|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655394|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655395|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655396|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655397|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655398|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655399|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655400|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655401|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655402|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655403|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655427|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655404|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655405|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655406|NCT00391027|E2|Reported Event|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
655407|NCT00391027|E1|Reported Event|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
655408|NCT00390884|B3|Baseline|Total|Total of all reporting groups
655409|NCT00390884|B2|Baseline|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655410|NCT00390884|B1|Baseline|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655411|NCT00390884|P2|Participant Flow|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655412|NCT00390884|P1|Participant Flow|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655413|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655414|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655415|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655416|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655417|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655418|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655419|NCT00390884|E2|Reported Event|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655420|NCT00390884|E1|Reported Event|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
655421|NCT00390858|B3|Baseline|Total|Total of all reporting groups
655422|NCT00390858|B2|Baseline|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655423|NCT00390858|B1|Baseline|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655424|NCT00390858|P2|Participant Flow|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655425|NCT00390858|P1|Participant Flow|Children ( < 12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655638|NCT00390559|O1|Outcome|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
655428|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655429|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655430|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655431|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655432|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655433|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
655434|NCT00390858|E2|Reported Event|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
655435|NCT00390858|E1|Reported Event|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
655436|NCT00390806|B3|Baseline|Total|Total of all reporting groups
655437|NCT00390806|B2|Baseline|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655438|NCT00390806|B1|Baseline|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655439|NCT00390806|P2|Participant Flow|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655440|NCT00390806|P1|Participant Flow|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655441|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655442|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655443|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655444|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655445|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655446|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655447|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655448|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655449|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655450|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655451|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655452|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655453|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655454|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655455|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655456|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655457|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655458|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655459|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655639|NCT00390559|E4|Reported Event|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
655640|NCT00390559|E3|Reported Event|Active P/PlaceboC|21 mg patch/no nicotine cigarette
655460|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655461|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655462|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655463|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655464|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655465|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655466|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655467|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655468|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655469|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655470|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655471|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655472|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655473|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655641|NCT00390559|E2|Reported Event|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
655642|NCT00390559|E1|Reported Event|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
655643|NCT00390546|B3|Baseline|Total|Total of all reporting groups
655784|NCT00389831|B1|Baseline|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
655474|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655475|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655476|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655477|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655478|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655479|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655480|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655481|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655482|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655483|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655484|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655485|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655486|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655487|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655644|NCT00390546|B2|Baseline|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
655830|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655488|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655489|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655490|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655491|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655492|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655493|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655494|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655495|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655496|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655497|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655498|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655499|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655500|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655501|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655645|NCT00390546|B1|Baseline|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
655831|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655502|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655503|NCT00390806|E2|Reported Event|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
655504|NCT00390806|E1|Reported Event|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
655505|NCT00390780|B3|Baseline|Total|Total of all reporting groups
655506|NCT00390780|B2|Baseline|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655507|NCT00390780|B1|Baseline|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655508|NCT00390780|P2|Participant Flow|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day, for 14 days
655509|NCT00390780|P1|Participant Flow|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655510|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655511|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655512|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655513|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655514|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655515|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655516|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655517|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655518|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655519|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655520|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655521|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655522|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655523|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655524|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655525|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655526|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655527|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655528|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655529|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655530|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655531|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655532|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655533|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655534|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655535|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655536|NCT00390780|E2|Reported Event|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
655537|NCT00390780|E1|Reported Event|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
655538|NCT00390689|B4|Baseline|Total|Total of all reporting groups
655539|NCT00390689|B3|Baseline|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655540|NCT00390689|B2|Baseline|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655541|NCT00390689|B1|Baseline|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655542|NCT00390689|P3|Participant Flow|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655543|NCT00390689|P2|Participant Flow|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655544|NCT00390689|P1|Participant Flow|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655545|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655546|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655547|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655548|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
656805|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
655549|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655550|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655551|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655552|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655553|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655554|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655555|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655556|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655557|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655558|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655559|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655832|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655560|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655561|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655562|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655563|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655564|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655565|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655566|NCT00390689|O3|Outcome|Pramipexole 0.50mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655567|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655568|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655569|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655570|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655833|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655571|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655572|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655573|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655574|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655575|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655576|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655577|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655578|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655646|NCT00390546|P2|Participant Flow|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
655834|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655835|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655579|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655580|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655581|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655582|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655583|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655584|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655585|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655586|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
656806|NCT00386334|O1|Outcome|Placebo|Placebo tablets
655587|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655588|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655589|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655590|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655591|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655592|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655593|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655594|NCT00390689|E7|Reported Event|Pramipexole 0.75mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655716|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
655595|NCT00390689|E6|Reported Event|Pramipexole 0.50mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655596|NCT00390689|E5|Reported Event|Pramipexole 0.25mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655597|NCT00390689|E4|Reported Event|Pramipexole 0.125mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
655598|NCT00390689|E3|Reported Event|Pramipexole 0.75mg (Double-blind)|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily"
655599|NCT00390689|E2|Reported Event|Pramipexole 0.50mg (Double-blind)|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily"
655600|NCT00390689|E1|Reported Event|Pramipexole 0.25mg (Double-blind)|"Double-blind period: 0.25 mg randomised group.~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily"
655601|NCT00390611|B3|Baseline|Total|Total of all reporting groups
655602|NCT00390611|B2|Baseline|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
655603|NCT00390611|B1|Baseline|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
655604|NCT00390611|P2|Participant Flow|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
655605|NCT00390611|P1|Participant Flow|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
655606|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
655607|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
655608|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
655609|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
655610|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
655611|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
655612|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
655613|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
655614|NCT00390611|E2|Reported Event|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
655615|NCT00390611|E1|Reported Event|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
655616|NCT00390572|B3|Baseline|Total|Total of all reporting groups
655617|NCT00390572|B2|Baseline|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
655618|NCT00390572|B1|Baseline|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
655619|NCT00390572|P2|Participant Flow|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
656807|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
655620|NCT00390572|P1|Participant Flow|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers."
655621|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
655622|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
655623|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
655624|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
655625|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
655626|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
655627|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
655628|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
655629|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
655630|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
655631|NCT00390572|E2|Reported Event|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
655632|NCT00390572|E1|Reported Event|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
655633|NCT00390559|B1|Baseline|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
655634|NCT00390559|P1|Participant Flow|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
655635|NCT00390559|O4|Outcome|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
655636|NCT00390559|O3|Outcome|Active P/PlaceboC|21 mg patch/no nicotine cigarette
655637|NCT00390559|O2|Outcome|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
655647|NCT00390546|P1|Participant Flow|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
655648|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
655649|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
655650|NCT00390546|O2|Outcome|Propranolol|Single dose administered orally at 0.5/kg per dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
655651|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
655652|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
655653|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
655654|NCT00390546|E2|Reported Event|Propranolol|
655655|NCT00390546|E1|Reported Event|Digoxin|
655656|NCT00390468|B1|Baseline|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
655657|NCT00390468|P1|Participant Flow|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
655658|NCT00390468|O1|Outcome|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
655659|NCT00390468|E1|Reported Event|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
655660|NCT00390455|B3|Baseline|Total|Total of all reporting groups
655661|NCT00390455|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655662|NCT00390455|B1|Baseline|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655663|NCT00390455|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655664|NCT00390455|P1|Participant Flow|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655665|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655666|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655667|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655668|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655669|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655670|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655671|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655672|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655673|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655674|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655675|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655676|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655677|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655678|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655679|NCT00390455|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
655680|NCT00390455|E1|Reported Event|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
655681|NCT00390429|B4|Baseline|Total|Total of all reporting groups
655717|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
655836|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655682|NCT00390429|B3|Baseline|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655683|NCT00390429|B2|Baseline|Phase I, Arm B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655684|NCT00390429|B1|Baseline|Phase I, Arm A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655685|NCT00390429|P4|Participant Flow|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
655686|NCT00390429|P3|Participant Flow|Phase I, Group B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
655687|NCT00390429|P2|Participant Flow|Phase I, Group A (600 mg Erlotinib + 70mg/m2 Docetaxel)|"Patients receive docetaxel IV over 1 hour on day 1 and oral Erlotinib hydrochloride once on days 2, 9, and 16 and Docetaxel on days 1 and 22. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~Docetaxel: Given IV Erlotinib hydrochloride: Given orally"
655688|NCT00390429|P1|Participant Flow|Phase I, Group A (1200 mg Erlotinib + 70mg/m2 Docetaxel)|"Original Dose Level~Patients receive docetaxel IV over 1 hour on day 1 and oral Erlotinib hydrochloride once on days 2, 9, and 16 and Docetaxel on days 1 and 22. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~Docetaxel: Given IV Erlotinib hydrochloride: Given orally"
655689|NCT00390429|O1|Outcome|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655690|NCT00390429|O1|Outcome|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655691|NCT00390429|O1|Outcome|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655692|NCT00390429|O2|Outcome|Phase I, Group B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
655693|NCT00390429|O1|Outcome|Phase I, Group A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
655694|NCT00390429|O2|Outcome|Phase I, Group B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
655695|NCT00390429|O1|Outcome|Phase I, Group A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV erlotinib hydrochloride: Given orally"
655696|NCT00390429|O1|Outcome|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655718|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
655697|NCT00390429|O3|Outcome|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655698|NCT00390429|O2|Outcome|Phase I, Arm B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655699|NCT00390429|O1|Outcome|Phase I, Arm A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655700|NCT00390429|E3|Reported Event|Phase II|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655701|NCT00390429|E2|Reported Event|Phase I, Arm B (Completed)|"Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655702|NCT00390429|E1|Reported Event|Phase I, Arm A (Completed)|"Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.~docetaxel: Given IV~erlotinib hydrochloride: Given orally"
655703|NCT00390416|B1|Baseline|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
655704|NCT00390416|P1|Participant Flow|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|"Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin~Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes"
655705|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
655706|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
655707|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
655708|NCT00390416|E1|Reported Event|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
655709|NCT00390364|B1|Baseline|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
655710|NCT00390364|P1|Participant Flow|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
655711|NCT00390364|O1|Outcome|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
655712|NCT00390364|E1|Reported Event|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
655713|NCT00390234|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
655714|NCT00390234|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
655715|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
655719|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
655720|NCT00390234|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
655721|NCT00390221|B4|Baseline|Total|Total of all reporting groups
655722|NCT00390221|B3|Baseline|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655723|NCT00390221|B2|Baseline|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655724|NCT00390221|B1|Baseline|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
655725|NCT00390221|P3|Participant Flow|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655726|NCT00390221|P2|Participant Flow|150 mg DAC HYP|150 mg Daclizumab High Yield Process (DAC HYP) administered as 3 SC injections every 4 weeks for up to 52 weeks
655727|NCT00390221|P1|Participant Flow|Placebo|Placebo administered as 3 subcutaneous (SC) injections every 4 weeks for up to 52 weeks
655728|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655729|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655730|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
655731|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655732|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655733|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
655734|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655735|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655736|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
655737|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655738|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655739|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
655740|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655741|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655742|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
655743|NCT00390221|E4|Reported Event|Total Active|150 mg or 300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655744|NCT00390221|E3|Reported Event|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655745|NCT00390221|E2|Reported Event|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
655746|NCT00390221|E1|Reported Event|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
655747|NCT00390182|B1|Baseline|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
655748|NCT00390182|P1|Participant Flow|Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9)|4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9.
655749|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
655750|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
655751|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
655752|NCT00390182|E1|Reported Event|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
655753|NCT00390013|B4|Baseline|Total|Total of all reporting groups
655754|NCT00390013|B3|Baseline|Placebo (Phase 1)|
655755|NCT00390013|B2|Baseline|Gabapentin (Phase 1)|
655756|NCT00390013|B1|Baseline|All Cross Over Participants|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)~Gabapentin: 300 mg. capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of study treatment you will titrate off study drug over a weeks time.~Placebo:~Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (Gabapentin)."
655757|NCT00390013|P4|Participant Flow|Placebo Control Arm|1 phase Placebo
655758|NCT00390013|P3|Participant Flow|Treatment Only (Gabapentin)|1st phase (placebo controlled study) gabapentin 1800 mg max dose
655759|NCT00390013|P2|Participant Flow|Placebo Oral Capsule First Then Gabapentin Crossover|"Placebo titration and dosing for total of 8 weeks (Cross over)~Placebo oral capsule: Placebo capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2.~at completion of study treatment (week 11) you will titrate off study drug over a weeks time.~Gabapentin: 300 mg. capsules Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (placebo)."
655760|NCT00390013|P1|Participant Flow|Gabapentin First Then Placebo Crossover|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)~Gabapentin: 300 mg. capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of cross-over period 1 you will titrate off study drug over a weeks time.~Placebo:~Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (gabapentin)."
655761|NCT00390013|O2|Outcome|Placebo|
655762|NCT00390013|O1|Outcome|Gabapentin|
655763|NCT00390013|E2|Reported Event|Placebo Oral Capsule|"Placebo titration and dosing for total of 8 weeks (Cross over)~Placebo oral capsule: Placebo capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of study treatment you will titrate off study drug over a weeks time."
655764|NCT00390013|E1|Reported Event|Gabapentin|"Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)~Gabapentin: 300 mg. capsules~Dosage schedule for weeks 1 and 2 and weeks 12 and 13:~day 1 you will take 1 capsule for the day~day 2 you will take 1 capsule 2 times for that day~days 3-6 you will take 1 capsule 3 times for those days~days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day~days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day~days 13-14 you will take 2 capsules 3 times each day~continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.~at completion of study treatment you will titrate off study drug over a weeks time."
655765|NCT00389974|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
655766|NCT00389974|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
655767|NCT00389974|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
655768|NCT00389974|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
655769|NCT00389857|B3|Baseline|Total|Total of all reporting groups
655770|NCT00389857|B2|Baseline|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
655771|NCT00389857|B1|Baseline|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
655772|NCT00389857|P2|Participant Flow|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
655773|NCT00389857|P1|Participant Flow|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
655774|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
655775|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
655776|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
655777|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
655778|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
655779|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
655780|NCT00389857|E2|Reported Event|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
655781|NCT00389857|E1|Reported Event|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
655782|NCT00389831|B3|Baseline|Total|Total of all reporting groups
655783|NCT00389831|B2|Baseline|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
655837|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655785|NCT00389831|P2|Participant Flow|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
655786|NCT00389831|P1|Participant Flow|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
655787|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
655788|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
655789|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
655790|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
655791|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
655792|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
655793|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
655794|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
655795|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
655796|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
655797|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
655798|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
655799|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
655800|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
655801|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
655802|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
655803|NCT00389831|E8|Reported Event|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
655804|NCT00389831|E7|Reported Event|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
655805|NCT00389831|E6|Reported Event|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
655806|NCT00389831|E5|Reported Event|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
655807|NCT00389831|E4|Reported Event|Placebo - Day 4|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 4.
655808|NCT00389831|E3|Reported Event|Placebo - Day 3|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 3.
655809|NCT00389831|E2|Reported Event|Placebo - Day 2|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 2.
655810|NCT00389831|E1|Reported Event|Placebo - Day 1|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 1.
655811|NCT00389818|B1|Baseline|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
655812|NCT00389818|P1|Participant Flow|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
655813|NCT00389818|O1|Outcome|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
655814|NCT00389818|E1|Reported Event|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
655815|NCT00389805|B3|Baseline|Total|Total of all reporting groups
655816|NCT00389805|B2|Baseline|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655817|NCT00389805|B1|Baseline|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655818|NCT00389805|P2|Participant Flow|Arm B|Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m2) on days 1 and 8 every 21 days
655819|NCT00389805|P1|Participant Flow|Arm A|Pemetrexed on day 1 (500 -600 mg/m2 IV) and bortezomib twice weekly (0.7-1.3mg/m3) on days 1, 4, 8, and 11 every 21 days
655820|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655821|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655822|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655823|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655824|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655825|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655826|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655827|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655828|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655829|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655838|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655839|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655840|NCT00389805|O2|Outcome|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655841|NCT00389805|O1|Outcome|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655842|NCT00389805|E2|Reported Event|Arm B|Pemetrexed on day 1 and bortezomib days 1 and 8 every 21 days
655843|NCT00389805|E1|Reported Event|Arm A|Pemetrexed on day 1 and bortezomib days 1, 4, 8, and 11 every 21 days
655844|NCT00389597|B5|Baseline|Total|Total of all reporting groups
655845|NCT00389597|B4|Baseline|2 Level ACDF|2 level control procedure (ACDF)
655846|NCT00389597|B3|Baseline|2 Level TDR|Cervical artificial disc (investigational device) at 2 levels
655847|NCT00389597|B2|Baseline|1 Level ACDF|1 level control procedure (ACDF)
655848|NCT00389597|B1|Baseline|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
655849|NCT00389597|P4|Participant Flow|2 Level ACDF|2 level control procedure (ACDF)
655850|NCT00389597|P3|Participant Flow|2 Level TDR|Cervical artificial disc (investigational device) at 2 levels
655851|NCT00389597|P2|Participant Flow|1 Level ACDF|1 level control procedure (ACDF)
655852|NCT00389597|P1|Participant Flow|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
655853|NCT00389597|O4|Outcome|2 Level TDR|control procedure (ACDF) at two levels
655854|NCT00389597|O3|Outcome|2 Level ACDF|Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
655855|NCT00389597|O2|Outcome|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
655856|NCT00389597|O1|Outcome|1 Level ACDF|control procedure (ACDF) at one level
655857|NCT00389597|E4|Reported Event|2 Level ACDF Arm|
655858|NCT00389597|E3|Reported Event|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
655859|NCT00389597|E2|Reported Event|1 Level ACDF Arm|
655860|NCT00389597|E1|Reported Event|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
655861|NCT00389532|B3|Baseline|Total|Total of all reporting groups
655862|NCT00389532|B2|Baseline|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
655863|NCT00389532|B1|Baseline|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
655864|NCT00389532|P2|Participant Flow|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
655865|NCT00389532|P1|Participant Flow|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
655866|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
655867|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
655868|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
655869|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
655870|NCT00389532|E2|Reported Event|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
655871|NCT00389532|E1|Reported Event|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
655872|NCT00389519|B5|Baseline|Total|Total of all reporting groups
655873|NCT00389519|B4|Baseline|Ramipril High Dose|
655874|NCT00389519|B3|Baseline|Ramipril Mid Dose|
655875|NCT00389519|B2|Baseline|Ramipril Low Dose|
655876|NCT00389519|B1|Baseline|Placebo|
655877|NCT00389519|P4|Participant Flow|Ramipril High Dose|
655878|NCT00389519|P3|Participant Flow|Ramipril Mid Dose|
655879|NCT00389519|P2|Participant Flow|Ramipril Low Dose|
655880|NCT00389519|P1|Participant Flow|Placebo|
655881|NCT00389519|O4|Outcome|Ramipril High Dose|
655882|NCT00389519|O3|Outcome|Ramipril Mid Dose|
655883|NCT00389519|O2|Outcome|Ramipril Low Dose|
655884|NCT00389519|O1|Outcome|Placebo|
655885|NCT00389519|O4|Outcome|Ramipril High Dose|
655886|NCT00389519|O3|Outcome|Ramipril Mid Dose|
655887|NCT00389519|O2|Outcome|Ramipril Low Dose|
655888|NCT00389519|O1|Outcome|Placebo|
655889|NCT00389519|O4|Outcome|Ramipril High Dose|
655890|NCT00389519|O3|Outcome|Ramipril Mid Dose|
655891|NCT00389519|O2|Outcome|Ramipril Low Dose|
655892|NCT00389519|O1|Outcome|Placebo|
655893|NCT00389519|O4|Outcome|Ramipril High Dose|
655894|NCT00389519|O3|Outcome|Ramipril Mid Dose|
655895|NCT00389519|O2|Outcome|Ramipril Low Dose|
655896|NCT00389519|O1|Outcome|Placebo|
655897|NCT00389519|O4|Outcome|Ramipril High Dose|
655898|NCT00389519|O3|Outcome|Ramipril Mid Dose|
655899|NCT00389519|O2|Outcome|Ramipril Low Dose|
655900|NCT00389519|O1|Outcome|Placebo|
655901|NCT00389519|E4|Reported Event|Ramipril High Dose|
655902|NCT00389519|E3|Reported Event|Ramipril Mid Dose|
655903|NCT00389519|E2|Reported Event|Ramipril Low Dose|
655904|NCT00389519|E1|Reported Event|Placebo|
655905|NCT00389493|B4|Baseline|Total|Total of all reporting groups
655906|NCT00389493|B3|Baseline|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
655907|NCT00389493|B2|Baseline|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
655908|NCT00389493|B1|Baseline|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
655909|NCT00389493|P3|Participant Flow|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
655983|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655910|NCT00389493|P2|Participant Flow|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
655911|NCT00389493|P1|Participant Flow|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
655912|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
655913|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
655914|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
655915|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
655916|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
655917|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
655918|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
655919|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
655920|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
655921|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
655922|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
655923|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
655924|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
655925|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
655926|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
655927|NCT00389493|E3|Reported Event|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
655928|NCT00389493|E2|Reported Event|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
655929|NCT00389493|E1|Reported Event|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
655930|NCT00389467|B5|Baseline|Total|Total of all reporting groups
655931|NCT00389467|B4|Baseline|Standard Care, Nonpenumbral|Treatment assignment = standard medical care, imaging pattern = nonpenumbral
655932|NCT00389467|B3|Baseline|Embolectomy, Nonpenumbral|Treatment assignment = embolectomy, imaging pattern = nonpenumbral
655933|NCT00389467|B2|Baseline|Standard Care, Penumbral|Treatment assignment = standard medical care, imaging pattern = penumbral
655934|NCT00389467|B1|Baseline|Embolectomy, Penumbral|Treatment assignment = embolectomy, imaging pattern = penumbral
655935|NCT00389467|P4|Participant Flow|Standard Care, Nonpenumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
655984|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
655985|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655936|NCT00389467|P3|Participant Flow|Embolectomy, Nonpenumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
655937|NCT00389467|P2|Participant Flow|Standard Care, Penumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
655938|NCT00389467|P1|Participant Flow|Embolectomy, Penumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
655939|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
655940|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
655941|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655942|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655943|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
655944|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
655945|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655946|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655947|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
655948|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
655949|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655950|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655951|NCT00389467|E5|Reported Event|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
655952|NCT00389467|E4|Reported Event|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
656808|NCT00386334|O1|Outcome|Placebo|Placebo tablets
655953|NCT00389467|E3|Reported Event|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655954|NCT00389467|E2|Reported Event|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
655955|NCT00389467|E1|Reported Event|Total Cohort|
655956|NCT00389441|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655957|NCT00389441|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655958|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655959|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655960|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655961|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655962|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655963|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655964|NCT00389441|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
655965|NCT00389324|B1|Baseline|Safety Population|The safety population included all subjects who received any amount of study medication (IGIV-C) via intravenous (IV) and/or subcutaneous (SC) routes of administration. As such, the safety population included all study participants combined (who received any dose), whether they entered the study in the Run-In or Intravenous Phase.
655966|NCT00389324|P1|Participant Flow|IGIV-C|"21 subjects were required to enter a Run-In Phase (3 to 4 months) and received IGIV-C between 200 and 600 mg/kg by intravenous infusion every 3 or 4 weeks. 18 subjects completed the Run-In Phase and entered the Intravenous Phase.~A total of 32 subjects entered the IV Phase: 14 subjects who had received IV IGIV-C prior to screening directly entered the IV Phase and 18 subjects who had completed the Run-in Phase continued in the study to enter the IV Phase. Subjects in the IV Phase received two IV infusions at the same dose (200-600 mg/kg) and frequency (every 3 or 4 weeks) as their regular dose at screening or during the Run-In Phase. All 32 subjects completed the IV Phase and entered the SC Phase.~A total of 32 subjects who completed the IV Phase entered the SC Phase. Subjects in the SC Phase received IGIV-C via weekly SC administration for 24 weeks total at a dose that was calculated using a conversion factor and their established IV dose. 25 subjects completed the SC Phase."
655967|NCT00389324|O2|Outcome|Gamunex Subcutaneous (SC) Administration|Subjects who received Gamunex via SC administration.
655968|NCT00389324|O1|Outcome|Gamunex Intravenous (IV) Administration|Subjects who received Gamunex via IV administration.
655969|NCT00389324|E3|Reported Event|Subcutaneous Phase|All subjects who participated in the Subcutaneous Phase.
655970|NCT00389324|E2|Reported Event|Intravenous Phase|All subjects who participated in the Intravenous Phase.
655971|NCT00389324|E1|Reported Event|Run-In Phase|All subjects who participated in the Run-In Phase.
655972|NCT00389207|B4|Baseline|Total|Total of all reporting groups
655973|NCT00389207|B3|Baseline|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655974|NCT00389207|B2|Baseline|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655975|NCT00389207|B1|Baseline|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
655976|NCT00389207|P3|Participant Flow|Atazanvir/Ritonavir|Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
655977|NCT00389207|P2|Participant Flow|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655978|NCT00389207|P1|Participant Flow|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
655979|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655980|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655981|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
655982|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655986|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655987|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
655988|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655989|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655990|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
655991|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655992|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655993|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
655994|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655995|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655996|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
655997|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
655998|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
655999|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
656000|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656001|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656002|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
656003|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656004|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656005|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
656006|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656007|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656008|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656009|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656010|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656011|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656012|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656013|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656014|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656015|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656016|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656017|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656018|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656019|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656020|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656021|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656022|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656023|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656024|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656025|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656026|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656027|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656028|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656029|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656030|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656031|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656032|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656033|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656034|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656035|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656036|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656037|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656038|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656039|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656652|NCT00386477|P2|Participant Flow|Control|No vaginal cleansing or sham wash performed.
656040|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656041|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656042|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656043|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656044|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656045|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656046|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656047|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656048|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656049|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656050|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656051|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656052|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656053|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656054|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656055|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656056|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656057|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656058|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656059|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656060|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656061|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656062|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656063|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656064|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656065|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656066|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656067|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656068|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656069|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656070|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656071|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656072|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656073|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
656074|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656075|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
656076|NCT00389207|E3|Reported Event|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
656077|NCT00389207|E2|Reported Event|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
656078|NCT00389207|E1|Reported Event|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
656079|NCT00389168|B3|Baseline|Total|Total of all reporting groups
656080|NCT00389168|B2|Baseline|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656081|NCT00389168|B1|Baseline|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656082|NCT00389168|P2|Participant Flow|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
656083|NCT00389168|P1|Participant Flow|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
656084|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656085|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656086|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656087|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656088|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656089|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656090|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656091|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656092|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656093|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656094|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656095|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656096|NCT00389168|E2|Reported Event|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656097|NCT00389168|E1|Reported Event|Irbesratan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
656098|NCT00389064|B3|Baseline|Total|Total of all reporting groups
656099|NCT00389064|B2|Baseline|Placebo|
656100|NCT00389064|B1|Baseline|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656101|NCT00389064|P2|Participant Flow|Placebo|
656102|NCT00389064|P1|Participant Flow|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656103|NCT00389064|O2|Outcome|Placebo|
656104|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656105|NCT00389064|O2|Outcome|Placebo|
656106|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656107|NCT00389064|O2|Outcome|Placebo|
656108|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656109|NCT00389064|O2|Outcome|Placebo|
656110|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656111|NCT00389064|O2|Outcome|Placebo|
656112|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656113|NCT00389064|O2|Outcome|Placebo|
656114|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656115|NCT00389064|O2|Outcome|Placebo|
656116|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656117|NCT00389064|O2|Outcome|Placebo|
656118|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656119|NCT00389064|O2|Outcome|Placebo|
656120|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656121|NCT00389064|O2|Outcome|Placebo|
656122|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656123|NCT00389064|O2|Outcome|Placebo|
656124|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656125|NCT00389064|E2|Reported Event|Placebo|
656126|NCT00389064|E1|Reported Event|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
656127|NCT00388973|B3|Baseline|Total|Total of all reporting groups
656128|NCT00388973|B2|Baseline|Placebo|Placebo
656129|NCT00388973|B1|Baseline|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656130|NCT00388973|P2|Participant Flow|Placebo|Placebo
656131|NCT00388973|P1|Participant Flow|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656132|NCT00388973|O2|Outcome|Placebo|Placebo
656133|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656134|NCT00388973|O2|Outcome|Placebo|Placebo
656135|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656136|NCT00388973|O2|Outcome|Placebo|Placebo
656137|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656138|NCT00388973|O2|Outcome|Placebo|Placebo
656139|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656140|NCT00388973|O2|Outcome|Placebo|Placebo
656141|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656142|NCT00388973|O2|Outcome|Placebo|Placebo
656143|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656144|NCT00388973|O2|Outcome|Placebo|Placebo
656145|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656146|NCT00388973|O2|Outcome|Placebo|Placebo
656147|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656148|NCT00388973|E2|Reported Event|Placebo|Placebo
656149|NCT00388973|E1|Reported Event|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
656150|NCT00388947|B1|Baseline|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
656151|NCT00388947|P1|Participant Flow|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
656152|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
656153|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
656154|NCT00388947|E1|Reported Event|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
656155|NCT00388804|B3|Baseline|Total|Total of all reporting groups
656156|NCT00388804|B2|Baseline|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
656157|NCT00388804|B1|Baseline|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
656158|NCT00388804|P2|Participant Flow|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
656159|NCT00388804|P1|Participant Flow|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
656160|NCT00388804|O2|Outcome|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
656161|NCT00388804|O1|Outcome|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
656162|NCT00388804|E2|Reported Event|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
656163|NCT00388804|E1|Reported Event|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
656164|NCT00388726|B3|Baseline|Total|Total of all reporting groups
656165|NCT00388726|B2|Baseline|Treatment of Physician's Choice|Treatment of Physician's Choice
656166|NCT00388726|B1|Baseline|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
656167|NCT00388726|P2|Participant Flow|Treatment of Physician's Choice|Treatment of Physician's Choice
656168|NCT00388726|P1|Participant Flow|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
656169|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
656170|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
656171|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
656172|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
656173|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
656174|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
656175|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
656176|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
656177|NCT00388726|E2|Reported Event|Treatment of Physician's Choice|Treatment of Physician's Choice
656178|NCT00388726|E1|Reported Event|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
656179|NCT00388583|B3|Baseline|Total|Total of all reporting groups
656180|NCT00388583|B2|Baseline|Fluzone IM Vaccine Group|Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
656181|NCT00388583|B1|Baseline|Fluzone ID Vaccine Group|Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
656182|NCT00388583|P2|Participant Flow|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
656183|NCT00388583|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
656184|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
656185|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
656186|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
656187|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
656188|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
656189|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
656190|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
656191|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
656192|NCT00388583|E2|Reported Event|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
656193|NCT00388583|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
656194|NCT00388505|B3|Baseline|Total|Total of all reporting groups
656195|NCT00388505|B2|Baseline|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656196|NCT00388505|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656197|NCT00388505|P2|Participant Flow|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656198|NCT00388505|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656199|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656654|NCT00386477|O2|Outcome|Control|No vaginal cleansing or sham wash performed.
656200|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656201|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656202|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656203|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656204|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656205|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656206|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656207|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656208|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656209|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656210|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656211|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656212|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656213|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656214|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656215|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656216|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656217|NCT00388505|E2|Reported Event|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656218|NCT00388505|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
656219|NCT00388453|B4|Baseline|Total|Total of all reporting groups
656220|NCT00388453|B3|Baseline|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing,and hoarseness.
656221|NCT00388453|B2|Baseline|Volunteers With Gastroesophageal Reflux Disaese (GERD)|History of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy
656222|NCT00388453|B1|Baseline|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
656223|NCT00388453|P3|Participant Flow|Volunteers With Laryngopharangeal Reflux (LPR)|Patients suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing and hoarseness. This group included non-smokers with unremarkable chest radiographs who had undergone extensive testing and exclusion of other common causes for their laryngeal symptoms by the Vanderbilt Allergy, Sinus and Asthma Program (ASAP), and Vanderbilt Voice Center (spirometry, methacholine challenge, sputum eosinophil count, otolaryngology exam, high-resolution computerized tomography scan of the thorax and sinuses and sinus testing).
656224|NCT00388453|P2|Participant Flow|Volunteers With History of Gastroesophageal Reflux Disease|Patients with a history of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of their symptoms with PPI use and if they had erosive esophagitis by Los Angeles classification at endoscopy.
656329|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656225|NCT00388453|P1|Participant Flow|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
656226|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
656227|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
656228|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
656229|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
656230|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
656231|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
656232|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
656233|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
656234|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
656235|NCT00388453|O3|Outcome|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
656236|NCT00388453|O2|Outcome|Volunteers With History of Gastroesophageal Reflux Disease|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy.
656237|NCT00388453|O1|Outcome|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
656238|NCT00388453|E3|Reported Event|Volunteers With Laryngopharangeal Reflux (LPR)|Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness.
656239|NCT00388453|E2|Reported Event|Volunteers With Gastroesphageal Reflux Disease (GERD)|GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at time of endoscopy.
656240|NCT00388453|E1|Reported Event|Healthy Volunteers With no History of GERD or EERD or PPI Use|"Healthy volunteers with no history of GERD or EERD or PPI use~Dx-pH Probe: 24 hour ph monitoring~Manometry: procedure to measure LES and UES"
656241|NCT00388414|B3|Baseline|Total|Total of all reporting groups
656242|NCT00388414|B2|Baseline|Duloxetine Then Placebo|In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks.
656243|NCT00388414|B1|Baseline|Placebo Then Duloxetine|In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week).
656244|NCT00388414|P2|Participant Flow|Duloxetine Then Placebo|In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks.
656245|NCT00388414|P1|Participant Flow|Placebo Then Duloxetine|In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week).
656246|NCT00388414|O3|Outcome|Duloxetine|duloxetine: 30-60mg of duloxetine daily
656247|NCT00388414|O2|Outcome|Placebo - Sugar Pill|Placebo: Placebo pill once daily
656248|NCT00388414|O1|Outcome|Baseline|Pre-treatment
656249|NCT00388414|O2|Outcome|Duloxetine|duloxetine: 30-60mg of duloxetine daily
656250|NCT00388414|O1|Outcome|Placebo - Sugar Pill|Placebo: Placebo pill once daily
656251|NCT00388414|E1|Reported Event|All Participants|"Includes all participants.~Placebo: Placebo pill once daily Duloxetine: 30-60mg of duloxetine daily"
656252|NCT00388362|B1|Baseline|Sirolimus|Administration of Sirolimus and Prednisone
656253|NCT00388362|P1|Participant Flow|Sirolimus Therapy|Administration of Sirolimus and Prednisone
656254|NCT00388362|O1|Outcome|Sirolimus Therapy|Administration of Sirolimus and Prednisone
656255|NCT00388362|O1|Outcome|Sirolimus Therapy|Administration of Sirolimus and Prednisone
656256|NCT00388362|E1|Reported Event|Sirolimus Therapy|Administration of Sirolimus and Prednisone
656257|NCT00388349|B1|Baseline|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656258|NCT00388349|P2|Participant Flow|1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656259|NCT00388349|P1|Participant Flow|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656260|NCT00388349|O1|Outcome|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine 1250 mg/m2 administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656261|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656262|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656263|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656264|NCT00388349|O2|Outcome|1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656265|NCT00388349|O1|Outcome|1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656266|NCT00388349|E1|Reported Event|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
656267|NCT00388154|B1|Baseline|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
656268|NCT00388154|P1|Participant Flow|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
656269|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
656270|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
656271|NCT00388154|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
656272|NCT00388037|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
656273|NCT00388037|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
656274|NCT00388037|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
656275|NCT00388037|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
656276|NCT00387959|B1|Baseline|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
656277|NCT00387959|P1|Participant Flow|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
656278|NCT00387959|O1|Outcome|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
656279|NCT00387959|E1|Reported Event|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
656280|NCT00387894|B1|Baseline|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
656281|NCT00387894|P1|Participant Flow|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
656282|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
656283|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
656284|NCT00387894|E1|Reported Event|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
656285|NCT00387881|B3|Baseline|Total|Total of all reporting groups
656780|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656286|NCT00387881|B2|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population
656287|NCT00387881|B1|Baseline|Placebo|Baseline Characteristics used the Safety Population. Not the Randomised Population
656288|NCT00387881|P2|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656289|NCT00387881|P1|Participant Flow|Placebo|
656290|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656291|NCT00387881|O1|Outcome|Placebo|
656292|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656293|NCT00387881|O1|Outcome|Placebo|
656294|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656295|NCT00387881|O1|Outcome|Placebo|
656296|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656297|NCT00387881|O1|Outcome|Placebo|
656298|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656299|NCT00387881|O1|Outcome|Placebo|
656300|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656301|NCT00387881|O1|Outcome|Placebo|
656302|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656303|NCT00387881|O1|Outcome|Placebo|
656304|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656305|NCT00387881|O1|Outcome|Placebo|
656306|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656307|NCT00387881|O1|Outcome|Placebo|
656308|NCT00387881|E2|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
656309|NCT00387881|E1|Reported Event|Placebo|
656310|NCT00387829|B3|Baseline|Total|Total of all reporting groups
656311|NCT00387829|B2|Baseline|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
656312|NCT00387829|B1|Baseline|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
656313|NCT00387829|P2|Participant Flow|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
656314|NCT00387829|P1|Participant Flow|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
656315|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
656316|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
656317|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
656318|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
656319|NCT00387829|E2|Reported Event|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
656320|NCT00387829|E1|Reported Event|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
656321|NCT00387790|B1|Baseline|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
656322|NCT00387790|P1|Participant Flow|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
656323|NCT00387790|O1|Outcome|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
656324|NCT00387790|O1|Outcome|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
656325|NCT00387790|O1|Outcome|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
656326|NCT00387790|E1|Reported Event|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
656327|NCT00387764|B1|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656328|NCT00387764|P1|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656330|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656331|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656332|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656333|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656334|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656335|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656336|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656337|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656338|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656339|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656340|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656341|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656342|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656343|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656344|NCT00387764|E1|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
656345|NCT00387751|B1|Baseline|Bevacizumab and Sorafenib|
656346|NCT00387751|P1|Participant Flow|Bevacizumab and Sorafenib|
656347|NCT00387751|O1|Outcome|Survival|No data collected
656348|NCT00387751|O1|Outcome|Safety and Tolerability|No data collected
656349|NCT00387751|O1|Outcome|Bevacizumab and Sorafenib|"Bevacizumab was administered as a 5 mg/kg intravenous dose every 2 weeks. The dose was based on the patient's actual body weight; the dose recalculated if there was a weight change of >10% from baseline.~Sorafenib was administered as a 200 mg oral dose twice daily, for 5 days every 7 days. Courses will be defined as 28-day treatment periods and will be repeated without interruption until development of progressive disease or development of serious drug related toxicities."
656350|NCT00387751|E1|Reported Event|Bevacizumab and Sorafenib|
656351|NCT00387725|B5|Baseline|Total|Total of all reporting groups
656352|NCT00387725|B4|Baseline|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
656353|NCT00387725|B3|Baseline|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
656354|NCT00387725|B2|Baseline|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
656355|NCT00387725|B1|Baseline|Twinrix|Given on a 0, 1-, 6- month schedule
656356|NCT00387725|P4|Participant Flow|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
656357|NCT00387725|P3|Participant Flow|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
656358|NCT00387725|P2|Participant Flow|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
656359|NCT00387725|P1|Participant Flow|Twinrix|Given on a 0, 1-, 6- month schedule
656360|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
656361|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
656362|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
656363|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
656364|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
656365|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
656366|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
656367|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
656368|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
656369|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
656370|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
656371|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
656372|NCT00387725|E4|Reported Event|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
656373|NCT00387725|E3|Reported Event|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
656374|NCT00387725|E2|Reported Event|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
656375|NCT00387725|E1|Reported Event|Twinrix|Given on a 0, 1-, 6- month schedule
656376|NCT00387712|B3|Baseline|Total|Total of all reporting groups
656377|NCT00387712|B2|Baseline|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
656378|NCT00387712|B1|Baseline|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
656379|NCT00387712|P2|Participant Flow|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
656380|NCT00387712|P1|Participant Flow|Velocity Based Treadmill Training|6-month treadmill exercise progressed on speed based on individual participant's tolerance, abilities and safety.
656381|NCT00387712|O2|Outcome|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
656382|NCT00387712|O1|Outcome|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
656383|NCT00387712|O2|Outcome|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
656384|NCT00387712|O1|Outcome|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
656405|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656385|NCT00387712|O2|Outcome|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
656386|NCT00387712|O1|Outcome|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
656387|NCT00387712|E2|Reported Event|Duration Based Treadmill Training|6-month treadmill exercise at self-selected speed progressed only on training duration.
656388|NCT00387712|E1|Reported Event|Velocity Based Treadmill Training|6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
656389|NCT00387673|B1|Baseline|Effect of Prolonged Electrical Stimulation on Neural Plastici|
656390|NCT00387673|P3|Participant Flow|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
656391|NCT00387673|P2|Participant Flow|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
656392|NCT00387673|P1|Participant Flow|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
656393|NCT00387673|O3|Outcome|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
656394|NCT00387673|O2|Outcome|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
656395|NCT00387673|O1|Outcome|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
656396|NCT00387673|E1|Reported Event|Project Closed|
656397|NCT00387660|B3|Baseline|Total|Total of all reporting groups
656398|NCT00387660|B2|Baseline|Arm B|Relapsed small cell lung cancer with previous chemotherapy
656399|NCT00387660|B1|Baseline|Arm A|Metastatic small cell lung cancer with no previous chemotherapy
656400|NCT00387660|P2|Participant Flow|Arm B - Relapsed SCLC (Previous Chemo)|Relapsed small cell lung cancer with previous chemotherapy
656401|NCT00387660|P1|Participant Flow|Arm A - Metastatic SCLC (no Previous Chemo)|Extensive small cell lung cancer with no previous chemotherapy
656402|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656403|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656404|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656406|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656407|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656408|NCT00387660|E2|Reported Event|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656409|NCT00387660|E1|Reported Event|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
656410|NCT00387647|B1|Baseline|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
656411|NCT00387647|P1|Participant Flow|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
656412|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
656413|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
656414|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
656415|NCT00387647|E1|Reported Event|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
656416|NCT00387621|B4|Baseline|Total|Total of all reporting groups
656417|NCT00387621|B3|Baseline|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
656418|NCT00387621|B2|Baseline|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
656419|NCT00387621|B1|Baseline|Control Group (Normals)|Healthy volunteers without heart disease
656420|NCT00387621|P2|Participant Flow|Nesiritide First, Then Placebo (Arm B)|In the first intervention period the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
656421|NCT00387621|P1|Participant Flow|Placebo First, Then Nesiritide (Arm A)|In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
656422|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
656423|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
656424|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
656425|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
656426|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
656427|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
656428|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
656429|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
656430|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
656431|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
656432|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
656433|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
656434|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656435|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656436|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656437|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656466|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
656653|NCT00386477|P1|Participant Flow|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
656438|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656439|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656440|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656441|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656442|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656443|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656444|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656445|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656446|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) and Nesiritide First, then Placebo (Arm B).
656447|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
656448|NCT00387621|E2|Reported Event|Nesiritide|The first 10 subjects in each group received a dose of 5 ug/kg and the next 10 subjects received a dose of 10 ug/kg. As this was a cross over study, all participants received placebo and nesiritide.
656449|NCT00387621|E1|Reported Event|Placebo|The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. As this was a cross over study, all participants received placebo and nesiritide.
656450|NCT00387426|B1|Baseline|Sunitinib|37.5 mg orally daily for 6-week cycle
656451|NCT00387426|P1|Participant Flow|Sunitinib|37.5 mg orally daily for 6-week cycle
656452|NCT00387426|O1|Outcome|Sunitinib|37.5 mg orally daily for 6-week cycle
656453|NCT00387426|E1|Reported Event|Sunitinib|37.5 mg orally daily for 6-week cycle
656454|NCT00387348|B4|Baseline|Total|Total of all reporting groups
656455|NCT00387348|B3|Baseline|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
656456|NCT00387348|B2|Baseline|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
656457|NCT00387348|B1|Baseline|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
656458|NCT00387348|P3|Participant Flow|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
656459|NCT00387348|P2|Participant Flow|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
656460|NCT00387348|P1|Participant Flow|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.
656461|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
656462|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
656463|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
656464|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
656465|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
656535|NCT00387088|B3|Baseline|Total|Total of all reporting groups
656467|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
656468|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
656469|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks
656470|NCT00387348|E3|Reported Event|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
656471|NCT00387348|E2|Reported Event|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
656472|NCT00387348|E1|Reported Event|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
656473|NCT00387335|B3|Baseline|Total|Total of all reporting groups
656474|NCT00387335|B2|Baseline|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
656475|NCT00387335|B1|Baseline|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
656476|NCT00387335|P2|Participant Flow|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.ECOG Performance Status 2.
656477|NCT00387335|P1|Participant Flow|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
656478|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656479|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656480|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656481|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656482|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656483|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656484|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656485|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
656486|NCT00387335|E2|Reported Event|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
656487|NCT00387335|E1|Reported Event|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
656488|NCT00387153|B1|Baseline|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
656489|NCT00387153|P1|Participant Flow|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
656490|NCT00387153|O1|Outcome|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
656491|NCT00387153|E1|Reported Event|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
656492|NCT00387127|B3|Baseline|Total|Total of all reporting groups
656493|NCT00387127|B2|Baseline|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656494|NCT00387127|B1|Baseline|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656536|NCT00387088|B2|Baseline|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656537|NCT00387088|B1|Baseline|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656538|NCT00387088|P2|Participant Flow|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656495|NCT00387127|P2|Participant Flow|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656496|NCT00387127|P1|Participant Flow|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656497|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656498|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656499|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656500|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656501|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656502|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656503|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656504|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656505|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656506|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656507|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656508|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656509|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656510|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656511|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656512|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656513|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656514|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656515|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656516|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656517|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656518|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656519|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656520|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656521|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656522|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656523|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656524|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656525|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656526|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656527|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656528|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656529|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656530|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656531|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction &lt;2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656532|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656533|NCT00387127|E2|Reported Event|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
656534|NCT00387127|E1|Reported Event|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
656539|NCT00387088|P1|Participant Flow|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656540|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656541|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656542|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656543|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656544|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656545|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656546|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656547|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656548|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656549|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656550|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656551|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656552|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656553|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656554|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656555|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656556|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656557|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656558|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656559|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656560|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656561|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656562|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656563|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656564|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656565|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656566|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656567|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656568|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656569|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656570|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656571|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656572|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656573|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656574|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656575|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656576|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656577|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656578|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656579|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656580|NCT00387088|E2|Reported Event|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656581|NCT00387088|E1|Reported Event|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
656582|NCT00387036|B1|Baseline|Entire Study Population|
656583|NCT00387036|P2|Participant Flow|Placebo Then Fluticasone Propionate|Following 1 week Placebo run-in period (Period I), patients were randomized to receive placebo 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week fluticasone propionate 250 mcg HFA 2 inhalations twice daily (Period IV).
656584|NCT00387036|P1|Participant Flow|Fluticasone Propionate Then Placebo|Following 1 week Placebo run-in period (Period I), patients were randomized to receive fluticasone propionate 250 mcg Hydrofluoroalkane (HFA) 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week placebo 2 inhalations twice daily (Period IV).
656585|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
656586|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
656587|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
656588|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
656589|NCT00387036|E2|Reported Event|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
656590|NCT00387036|E1|Reported Event|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
656591|NCT00387023|B1|Baseline|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
656592|NCT00387023|P1|Participant Flow|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
656593|NCT00387023|O1|Outcome|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
656594|NCT00387023|E1|Reported Event|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
656595|NCT00387010|B1|Baseline|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656596|NCT00387010|P1|Participant Flow|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656597|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656598|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656599|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656600|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656601|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656602|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656603|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656604|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656605|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656646|NCT00386607|E3|Reported Event|Core Period: Aliskiren / Valsartan|Core Period: Aliskiren/Valsartan
656606|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656607|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656608|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656609|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656610|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656611|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656612|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656613|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656614|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656615|NCT00387010|E1|Reported Event|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
656616|NCT00386880|B1|Baseline|Subjects With Episodic Migraine|Subjects with less than 8 distict migraine episodes per month.
656617|NCT00386880|P2|Participant Flow|Subjects With Episodic Migraine Without Allodynia|These are the subjects with episodic migraine without allodynia.
656618|NCT00386880|P1|Participant Flow|Subjects With Episodic Migraine With Allodynia|These are the subjects with episodic migraine with allodynia.
656619|NCT00386880|O2|Outcome|Subjects With Episodic Migraine Without Allodynia|These are subjects with episodic migraine without allodynia
656620|NCT00386880|O1|Outcome|Subjects With Episodic Migraine With Allodynia|These are subjects with episodic migraine with allodynia
656621|NCT00386880|E1|Reported Event|Subjects With Episodic Migraine|
656622|NCT00386776|B1|Baseline|Experimental|The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
656623|NCT00386776|P1|Participant Flow|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
656624|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
656625|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
656626|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
656647|NCT00386607|E2|Reported Event|Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone|Core Period: Aliskiren 300 mg /Valsartan 320 mg alone
656648|NCT00386607|E1|Reported Event|Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone|Core Period: Aliskiren 150 mg /Valsartan 160 mg alone
656649|NCT00386477|B3|Baseline|Total|Total of all reporting groups
656650|NCT00386477|B2|Baseline|Control|No vaginal cleansing or sham wash performed.
656651|NCT00386477|B1|Baseline|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
656627|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
656628|NCT00386776|O1|Outcome|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
656629|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
656630|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
656631|NCT00386776|E1|Reported Event|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
656632|NCT00386607|B1|Baseline|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
656633|NCT00386607|P2|Participant Flow|Extension Treatment|"For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.~Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.~The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits."
656634|NCT00386607|P1|Participant Flow|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
656635|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
656636|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
656637|NCT00386607|O1|Outcome|Core and Extension Treatment - Aliskiren/Valsartan/HCTZ|All patients receiving aliskiren / valsartan / HCTZ during either core or extension study.
656638|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
656639|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
656640|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
656641|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
656642|NCT00386607|O1|Outcome|Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
656643|NCT00386607|E6|Reported Event|Core and Extension: Total|Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
656644|NCT00386607|E5|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg|Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
656645|NCT00386607|E4|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
656781|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656655|NCT00386477|O1|Outcome|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
656656|NCT00386477|E2|Reported Event|Control|No vaginal cleansing or sham wash performed.
656657|NCT00386477|E1|Reported Event|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
656658|NCT00386425|B4|Baseline|Total|Total of all reporting groups
656659|NCT00386425|B3|Baseline|Randomized Non-ITT Population|
656660|NCT00386425|B2|Baseline|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656661|NCT00386425|B1|Baseline|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656662|NCT00386425|P3|Participant Flow|Randomized Non-ITT Population|Participants were randomized to either the Standard or Alternative Therapy and received 24 mcg/kg/hr during the first 24 hours (common therapy period); however, they did not continue on to receive the actual randomized therapy.
656663|NCT00386425|P2|Participant Flow|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656664|NCT00386425|P1|Participant Flow|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656665|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656666|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656667|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656668|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656669|NCT00386425|O2|Outcome|Did Not Normalize Protein C|
656670|NCT00386425|O1|Outcome|Normalized Protein C|
656671|NCT00386425|O4|Outcome|Alternative Therapy - Moderate Deficiency|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
656672|NCT00386425|O3|Outcome|Alternative Therapy - Severe Deficiency|Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656673|NCT00386425|O2|Outcome|Standard Therapy - Moderate Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656674|NCT00386425|O1|Outcome|Standard Therapy - Severe Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656675|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656676|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656677|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656678|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656679|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656680|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656681|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656682|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656683|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
656684|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
656685|NCT00386425|E2|Reported Event|Alternative Therapy|Participants assigned to alternative therapy (Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours) who received any amount of study drug.
656686|NCT00386425|E1|Reported Event|Standard Therapy|Participants assigned to standard therapy (24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours) who received any amount of study drug.
656687|NCT00386360|B3|Baseline|Total|Total of all reporting groups
656688|NCT00386360|B2|Baseline|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656689|NCT00386360|B1|Baseline|Placebo|Placebo, 1 tablet weekly on the same day
656690|NCT00386360|P2|Participant Flow|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656691|NCT00386360|P1|Participant Flow|Placebo|Placebo, 1 tablet weekly on the same day
656692|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656693|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656694|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656695|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656696|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656697|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656698|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656699|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656700|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656701|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656702|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656703|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656704|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656705|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656706|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656707|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656708|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656709|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656710|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656711|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656712|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656713|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656714|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656715|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656716|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656717|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656718|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656719|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
656720|NCT00386360|E2|Reported Event|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
656721|NCT00386360|E1|Reported Event|Placebo|Placebo, 1 tablet weekly on the same day
656722|NCT00386334|B3|Baseline|Total|Total of all reporting groups
656723|NCT00386334|B2|Baseline|Eszopiclone|Eszopiclone 2 mg tablets
656724|NCT00386334|B1|Baseline|Placebo|Placebo tablets
656725|NCT00386334|P2|Participant Flow|Eszopiclone|Eszopiclone 2 mg tablets
656726|NCT00386334|P1|Participant Flow|Placebo|Placebo tablets
656727|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656728|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656729|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656730|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656731|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656732|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656733|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656734|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656735|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656736|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656737|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656738|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656739|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656740|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656741|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656742|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656743|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656744|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656745|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656746|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656747|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656748|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656749|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656750|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656751|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656752|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656753|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656754|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656755|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656756|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656757|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656758|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656759|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656760|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656761|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656762|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656763|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656764|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656765|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656766|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656767|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656768|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656769|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656770|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656771|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656772|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656773|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656774|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656775|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656776|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656777|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656778|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656779|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656809|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656810|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656811|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656812|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656813|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656814|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656815|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656816|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656817|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656818|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656819|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656820|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656821|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656822|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656823|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656824|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656825|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656826|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656827|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656828|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656829|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656830|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656831|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656832|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656833|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656834|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656835|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656836|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656837|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656838|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656839|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656840|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656841|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656842|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656843|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656844|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656845|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656846|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656847|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656848|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656849|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656850|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656851|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656852|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656853|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656854|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656855|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656856|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656857|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656858|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656859|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656860|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656861|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656862|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656863|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
656864|NCT00386334|O1|Outcome|Placebo|Placebo tablets
656865|NCT00386334|E2|Reported Event|Eszopiclone|Eszopiclone 2 mg tablets
656866|NCT00386334|E1|Reported Event|Placebo|Placebo tablets
656867|NCT00386308|B3|Baseline|Total|Total of all reporting groups
656868|NCT00386308|B2|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
656869|NCT00386308|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
656870|NCT00386308|P2|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
656871|NCT00386308|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
656872|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
656873|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
656874|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
656875|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
656876|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
656877|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
656878|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
656879|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
656880|NCT00386308|E2|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
656881|NCT00386308|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
656882|NCT00386256|B5|Baseline|Total|Total of all reporting groups
656883|NCT00386256|B4|Baseline|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
656884|NCT00386256|B3|Baseline|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
656885|NCT00386256|B2|Baseline|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
656886|NCT00386256|B1|Baseline|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
656887|NCT00386256|P4|Participant Flow|Telephone Inpatient|
656888|NCT00386256|P3|Participant Flow|Health Buddy Inpatient|
656889|NCT00386256|P2|Participant Flow|Telephone Outpatient|
656890|NCT00386256|P1|Participant Flow|Health Buddy Outpatient|Health Buddy(R), Home telehealth technology : Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
656891|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
656892|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
656893|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
656894|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
656895|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
656896|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
656897|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
656898|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
656899|NCT00386256|E4|Reported Event|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
656900|NCT00386256|E3|Reported Event|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
656901|NCT00386256|E2|Reported Event|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
656902|NCT00386256|E1|Reported Event|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
656903|NCT00386243|B3|Baseline|Total|Total of all reporting groups
656904|NCT00386243|B2|Baseline|Arm 2|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
656905|NCT00386243|B1|Baseline|Arm 1|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
656906|NCT00386243|P2|Participant Flow|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
656907|NCT00386243|P1|Participant Flow|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
656908|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
656909|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
656910|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
656911|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
656954|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656955|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
660038|NCT00379639|B6|Baseline|Total|Total of all reporting groups
656912|NCT00386243|E2|Reported Event|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
656913|NCT00386243|E1|Reported Event|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
656914|NCT00386152|B4|Baseline|Total|Total of all reporting groups
656915|NCT00386152|B3|Baseline|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
656916|NCT00386152|B2|Baseline|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
656917|NCT00386152|B1|Baseline|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
656918|NCT00386152|P3|Participant Flow|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
656919|NCT00386152|P2|Participant Flow|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
656920|NCT00386152|P1|Participant Flow|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
656921|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
656922|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
656923|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
656924|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
656925|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
656926|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
656927|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
656928|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
656929|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
656930|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
656931|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
656932|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
656933|NCT00386152|E3|Reported Event|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
656934|NCT00386152|E2|Reported Event|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
656935|NCT00386152|E1|Reported Event|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
656936|NCT00386100|B3|Baseline|Total|Total of all reporting groups
656937|NCT00386100|B2|Baseline|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656938|NCT00386100|B1|Baseline|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656939|NCT00386100|P2|Participant Flow|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656940|NCT00386100|P1|Participant Flow|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656941|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656942|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656943|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656944|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656945|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656946|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656947|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656948|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656949|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656950|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656951|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656952|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656953|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656956|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656957|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656958|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656959|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656960|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656961|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656962|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656963|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656964|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656965|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656966|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656967|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656968|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656969|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656970|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656971|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656972|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656973|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656974|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656975|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656976|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656977|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656978|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656979|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656980|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656981|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656982|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656983|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656984|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656985|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656986|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656987|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656988|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656989|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656990|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656991|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656992|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656993|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656994|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656995|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
656996|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656997|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
660790|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
656998|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
656999|NCT00386100|E2|Reported Event|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
657000|NCT00386100|E1|Reported Event|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
657001|NCT00386022|B3|Baseline|Total|Total of all reporting groups
657002|NCT00386022|B2|Baseline|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
657003|NCT00386022|B1|Baseline|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
657004|NCT00386022|P2|Participant Flow|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
657005|NCT00386022|P1|Participant Flow|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
657006|NCT00386022|O2|Outcome|Older Postmenopausal Women|"Postmenopausal women aged 70-80 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
657007|NCT00386022|O1|Outcome|Young Postmenopausal Women|"Postmenopausal women aged 45-55 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
657008|NCT00386022|O2|Outcome|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
657009|NCT00386022|O1|Outcome|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
657010|NCT00386022|E2|Reported Event|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
657011|NCT00386022|E1|Reported Event|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
657012|NCT00386009|B3|Baseline|Total|Total of all reporting groups
657013|NCT00386009|B2|Baseline|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657014|NCT00386009|B1|Baseline|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657015|NCT00386009|P2|Participant Flow|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657016|NCT00386009|P1|Participant Flow|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657017|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657018|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657019|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657020|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657021|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657022|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657023|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657024|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657025|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657026|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657027|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657028|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657029|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657030|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657031|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657032|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657033|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657034|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657035|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657036|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657037|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657038|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657039|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657040|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657041|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657042|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657043|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657044|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657045|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657046|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657047|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657048|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657049|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657050|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657051|NCT00386009|E2|Reported Event|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
657052|NCT00386009|E1|Reported Event|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657053|NCT00385996|B1|Baseline|Erlotinib|Erlotinib 150 mg po daily
657054|NCT00385996|P1|Participant Flow|Erlotinib|Erlotinib 150 mg po daily.
657055|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
657056|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
657057|NCT00385996|E1|Reported Event|Erlotinib|Erlotinib 150 mg po daily.
657058|NCT00385944|B3|Baseline|Total|Total of all reporting groups
657059|NCT00385944|B2|Baseline|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
657060|NCT00385944|B1|Baseline|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
657061|NCT00385944|P3|Participant Flow|Loading Dose|Clopidogrel 900-mg Loading Dose (a single or cumulative dose)
657062|NCT00385944|P2|Participant Flow|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
657063|NCT00385944|P1|Participant Flow|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
657064|NCT00385944|O1|Outcome|Intent-to-treat Population|Both clopidogrel and prasugrel combined population
657065|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657066|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657067|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657068|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657069|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
657070|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
657071|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
657072|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
657073|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD)or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
657074|NCT00385944|O1|Outcome|Prasugrel/Clopidgrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
657075|NCT00385944|O1|Outcome|Clopidogrel 900 mg|Clopidogrel 900 mg LD (a single or cumulative dose)
657076|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657077|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657078|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657079|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657080|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657081|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657082|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657083|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657084|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657085|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
667114|NCT00360529|E1|Reported Event|Placebo|placebo at bedtime
657086|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657087|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657088|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657089|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657090|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657091|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657092|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657093|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657094|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657095|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657096|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
657097|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
657098|NCT00385944|E5|Reported Event|Prasugrel 10 mg - Crossover From Clopidogrel 150 mg|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.
657099|NCT00385944|E4|Reported Event|Clopidogrel 150 mg - Crossover From Prasugrel 10 mg|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.
657100|NCT00385944|E3|Reported Event|Clopidogrel 150 mg - 1st MD|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.
657101|NCT00385944|E2|Reported Event|Prasugrel 10 mg - 1st MD|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.
657102|NCT00385944|E1|Reported Event|Clopidogrel 900 mg LD|One time oral loading dose (LD) of 900-mg clopidogrel
657103|NCT00385918|B3|Baseline|Total|Total of all reporting groups
657104|NCT00385918|B2|Baseline|Home Stretching Then Lokomat Exercise|"Patients will participate in a home stretching program for 3 months. They will then be crossed over to Lokomat treatment for an additional 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm."
657105|NCT00385918|B1|Baseline|Lokomat Exercise|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657106|NCT00385918|P3|Participant Flow|Baseline and Feasibility Testing|All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
657107|NCT00385918|P2|Participant Flow|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~After 3 months the participants will be switched to a 3 month period of Lokomat training the same as that offered to the patients randomized to the Lokomat Training arm of the study."
657108|NCT00385918|P1|Participant Flow|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657109|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657110|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657111|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657206|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
657112|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657113|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657114|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657115|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657116|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657117|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657118|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657119|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657120|NCT00385918|O1|Outcome|Lokomat Treatment|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657121|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657122|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657123|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657124|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657125|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
657307|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657126|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657127|NCT00385918|E2|Reported Event|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program."
657128|NCT00385918|E1|Reported Event|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
657129|NCT00385840|B3|Baseline|Total|Total of all reporting groups
657130|NCT00385840|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657131|NCT00385840|B1|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657132|NCT00385840|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657133|NCT00385840|P1|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657134|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657135|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657136|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657137|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657138|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657139|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657140|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657141|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657142|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657143|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657144|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657145|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657146|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657207|NCT00385762|E1|Reported Event|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
657147|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657148|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657149|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657150|NCT00385840|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657151|NCT00385840|E1|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
657152|NCT00385827|B4|Baseline|Total|Total of all reporting groups
657153|NCT00385827|B3|Baseline|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657154|NCT00385827|B2|Baseline|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657155|NCT00385827|B1|Baseline|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657156|NCT00385827|P3|Participant Flow|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657157|NCT00385827|P2|Participant Flow|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657158|NCT00385827|P1|Participant Flow|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657159|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657160|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657161|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657162|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657208|NCT00385736|B4|Baseline|Total|Total of all reporting groups
667115|NCT00360490|B3|Baseline|Total|Total of all reporting groups
657163|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657164|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657165|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657166|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657167|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657168|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657169|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657170|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657171|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657172|NCT00385827|O1|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657173|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657174|NCT00385827|E3|Reported Event|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657175|NCT00385827|E2|Reported Event|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
657209|NCT00385736|B3|Baseline|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657210|NCT00385736|B2|Baseline|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657446|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657176|NCT00385827|E1|Reported Event|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
657177|NCT00385801|B3|Baseline|Total|Total of all reporting groups
657178|NCT00385801|B2|Baseline|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
657179|NCT00385801|B1|Baseline|Placebo|Identical placebo tablets and injections
657180|NCT00385801|P2|Participant Flow|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
657181|NCT00385801|P1|Participant Flow|Placebo|Identical placebo tablets and injections
657182|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
657183|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
657184|NCT00385801|O2|Outcome|Risperidone|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
657185|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
657186|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
657187|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
657188|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
657189|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
657190|NCT00385801|E2|Reported Event|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
657191|NCT00385801|E1|Reported Event|Placebo|Identical placebo tablets and injections
657192|NCT00385788|B3|Baseline|Total|Total of all reporting groups
657193|NCT00385788|B2|Baseline|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657194|NCT00385788|B1|Baseline|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657195|NCT00385788|P2|Participant Flow|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657196|NCT00385788|P1|Participant Flow|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657197|NCT00385788|O2|Outcome|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657198|NCT00385788|O1|Outcome|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657199|NCT00385788|E2|Reported Event|Gemcitabine + Fludarabine + Melphalan|Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657200|NCT00385788|E1|Reported Event|Fludarabine + Melphalan|Fludarabine 33 mg/m^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
657201|NCT00385762|B1|Baseline|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
657202|NCT00385762|P1|Participant Flow|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
657203|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
657204|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
657205|NCT00385762|O1|Outcome|Paroxetine|Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
657211|NCT00385736|B1|Baseline|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657212|NCT00385736|P3|Participant Flow|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657213|NCT00385736|P2|Participant Flow|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657214|NCT00385736|P1|Participant Flow|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657215|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657216|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657217|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657218|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657219|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657220|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657221|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657222|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657223|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
657224|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657225|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657226|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657227|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657228|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657229|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657230|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657231|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657232|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657233|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657234|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657235|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657236|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657237|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657238|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657239|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657240|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657241|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657242|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657243|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657244|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657245|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657246|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657304|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657247|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657248|NCT00385736|O3|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
657249|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
657250|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
657251|NCT00385736|E4|Reported Event|Any Adalimumab|Treatment group received at least 1 dose of adalimumab during the study. Adverse events include those reported from the first dose of adalimumab during the double-blind or open-label period.
657252|NCT00385736|E3|Reported Event|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
657253|NCT00385736|E2|Reported Event|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
657254|NCT00385736|E1|Reported Event|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6. Adverse events include those reported prior to dosing at Week 8.
657255|NCT00385723|B4|Baseline|Total|Total of all reporting groups
657256|NCT00385723|B3|Baseline|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
657257|NCT00385723|B2|Baseline|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
657258|NCT00385723|B1|Baseline|Placebo|Placebo : matching placebo capsule daily for 4 months
657259|NCT00385723|P3|Participant Flow|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
657260|NCT00385723|P2|Participant Flow|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
657261|NCT00385723|P1|Participant Flow|Placebo|Placebo : matching placebo capsule daily for 4 months
657262|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
657263|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
657264|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
657265|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
657266|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
657267|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
657268|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
657269|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
657270|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
657271|NCT00385723|E3|Reported Event|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
657272|NCT00385723|E2|Reported Event|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
657273|NCT00385723|E1|Reported Event|Placebo|Placebo : matching placebo capsule daily for 4 months
657274|NCT00385684|B1|Baseline|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
657275|NCT00385684|P2|Participant Flow|A2 THEN A1 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
657276|NCT00385684|P1|Participant Flow|A1 and Then A2 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
657277|NCT00385684|O1|Outcome|Phase B: Open Label|Those participants for whom the study medication was tolerated during Phase A (i.e., the closed label, double-blind phase of the trial) entered a six-week open-label phase.
657305|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657306|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657278|NCT00385684|O2|Outcome|Placebo Comparator: A2|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
657279|NCT00385684|O1|Outcome|Experimental: A1|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
657280|NCT00385684|E1|Reported Event|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
657281|NCT00385671|B4|Baseline|Total|Total of all reporting groups
657282|NCT00385671|B3|Baseline|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657283|NCT00385671|B2|Baseline|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657284|NCT00385671|B1|Baseline|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657285|NCT00385671|P3|Participant Flow|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657286|NCT00385671|P2|Participant Flow|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657287|NCT00385671|P1|Participant Flow|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657288|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657289|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657290|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657291|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657292|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657293|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657294|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657295|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657296|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657297|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657298|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657299|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657300|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657301|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657302|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657303|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657308|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657309|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657310|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657311|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657312|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657313|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657314|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657315|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657316|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657317|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657318|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657319|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657320|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657321|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657322|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657323|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657324|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657325|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657326|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657327|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657328|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657329|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657330|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657331|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657332|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657333|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657334|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657335|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657336|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657337|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657338|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657339|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657340|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657341|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657561|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657342|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657343|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657344|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657345|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657346|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657347|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657348|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657349|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657350|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657351|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657352|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657353|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657354|NCT00385671|O1|Outcome|Ordinary Coefficient|Beta-coefficient from regression analyses estimating direct and indirect treatment effects expressed in the observed scale of measurement of the dependent variable.
657355|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657356|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657357|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657358|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657359|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657360|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657361|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657362|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657363|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657364|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657365|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657366|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657367|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657368|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657369|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657370|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657371|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657372|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657373|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657374|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657375|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657562|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657376|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657377|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657378|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657379|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657380|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657381|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657382|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657383|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657384|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657385|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657386|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657387|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657388|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657389|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657390|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657391|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657392|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657393|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657394|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657395|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657396|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657397|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657398|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657399|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657400|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657401|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657402|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657403|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657404|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657405|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657406|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657407|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657408|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657409|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657410|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657411|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657412|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657413|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657414|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657415|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657416|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657417|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657418|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657419|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657420|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657421|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657422|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657423|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657424|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657425|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657426|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657427|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657428|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657429|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657430|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657431|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657432|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657433|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657434|NCT00385671|O1|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657435|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657436|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657437|NCT00385671|E3|Reported Event|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
657438|NCT00385671|E2|Reported Event|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
657439|NCT00385671|E1|Reported Event|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
657440|NCT00385593|B3|Baseline|Total|Total of all reporting groups
657441|NCT00385593|B2|Baseline|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657442|NCT00385593|B1|Baseline|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657443|NCT00385593|P2|Participant Flow|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657444|NCT00385593|P1|Participant Flow|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657445|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657447|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657448|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657449|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657450|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657451|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657452|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657453|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657454|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657455|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657456|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657457|NCT00385593|E2|Reported Event|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
657458|NCT00385593|E1|Reported Event|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
657459|NCT00385580|B3|Baseline|Total|Total of all reporting groups
657460|NCT00385580|B2|Baseline|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657461|NCT00385580|B1|Baseline|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657462|NCT00385580|P2|Participant Flow|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657463|NCT00385580|P1|Participant Flow|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657464|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (X dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657465|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (X dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657466|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657467|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (50 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657563|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657468|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (50 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657469|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657470|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657471|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657472|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657473|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657474|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657475|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657476|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657477|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657478|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657479|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657564|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657565|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657566|NCT00385541|E2|Reported Event|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657567|NCT00385541|E1|Reported Event|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657480|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657481|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657482|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657483|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657484|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657485|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657486|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657487|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657488|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657489|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657490|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657491|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657568|NCT00385515|B3|Baseline|Total|Total of all reporting groups
657569|NCT00385515|B2|Baseline|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
657570|NCT00385515|B1|Baseline|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
657745|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657492|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657493|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657494|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657495|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657496|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657497|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657498|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657499|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657500|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657501|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657502|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657503|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657571|NCT00385515|P2|Participant Flow|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
657572|NCT00385515|P1|Participant Flow|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
658116|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
657504|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657505|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657506|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657507|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657508|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657509|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657510|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657511|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657512|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657513|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657514|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657515|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657573|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
657574|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
658117|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
657516|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657517|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657518|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657519|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657520|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657521|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657522|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657523|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657524|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657525|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657526|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657527|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657575|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
657576|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
657577|NCT00385268|B3|Baseline|Total|Total of all reporting groups
657528|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657529|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657530|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657531|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657532|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657533|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657534|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657535|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657536|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657537|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657538|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657539|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657578|NCT00385268|B2|Baseline|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
657579|NCT00385268|B1|Baseline|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
667518|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
657540|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657541|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657542|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657543|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657544|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657545|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657546|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657547|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657548|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657549|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
657550|NCT00385580|E1|Reported Event|Dasatinib|All treated participants
657551|NCT00385541|B3|Baseline|Total|Total of all reporting groups
657552|NCT00385541|B2|Baseline|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657553|NCT00385541|B1|Baseline|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657554|NCT00385541|P2|Participant Flow|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657555|NCT00385541|P1|Participant Flow|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657556|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657557|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657558|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657559|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
657560|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
657735|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657580|NCT00385268|P2|Participant Flow|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
657581|NCT00385268|P1|Participant Flow|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
657582|NCT00385268|O2|Outcome|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
657583|NCT00385268|O1|Outcome|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
657584|NCT00385268|E2|Reported Event|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
657585|NCT00385268|E1|Reported Event|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
657586|NCT00385216|B1|Baseline|Entire Study Population|The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical.
657587|NCT00385216|P2|Participant Flow|Placebo Spray First, Then Nicotine|At the first intervention, the subject will receive a placebo nasal spray, 0 mg, one application. At the second intervention, the subject will receive a nicotine nasal spray, 3 mg, one application.
657588|NCT00385216|P1|Participant Flow|Nicotine Nasal Spray First, Then Placebo|At the first intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. At the second intervention, the subject will receive a placebo nasal spray, 0 mg, one application.
657589|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657590|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657591|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657592|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657593|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657594|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657595|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657596|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657597|NCT00385216|E2|Reported Event|Placebo|Sterile saline nasal spray was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657598|NCT00385216|E1|Reported Event|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
657599|NCT00385203|B3|Baseline|Total|Total of all reporting groups
657600|NCT00385203|B2|Baseline|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day: 10 patients with Soft Tissue Sarcomas (STS) randomised
657601|NCT00385203|B1|Baseline|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day: 25 patients with Gastrointestinal Stromal Tumour (GIST) randomised
657602|NCT00385203|P2|Participant Flow|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
657603|NCT00385203|P1|Participant Flow|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657604|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
657605|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657606|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
657607|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657608|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
657609|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657610|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
657611|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657612|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
657613|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657614|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
657736|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657737|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657615|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657616|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment
657617|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
657618|NCT00385203|E2|Reported Event|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment.
657619|NCT00385203|E1|Reported Event|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day patients with Gastrointestinal Stromal Tumour (GIST): 24 patients randomised and received at least one dose of treatment (1 patient was not randomised or dosed and a further 1 patient was randomised but not dosed due to Incorrect enrolmentCediranib)
657620|NCT00385138|B3|Baseline|Total|Total of all reporting groups
657621|NCT00385138|B2|Baseline|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657622|NCT00385138|B1|Baseline|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657623|NCT00385138|P2|Participant Flow|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657624|NCT00385138|P1|Participant Flow|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657625|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657626|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657627|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657628|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657629|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657630|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657631|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657632|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657633|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657634|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657635|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657636|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657637|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657638|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657639|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657640|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657641|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657738|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657642|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657643|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657644|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657645|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657646|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657647|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657648|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657649|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657650|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657651|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657652|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657653|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657654|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657655|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657656|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657657|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657658|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657659|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657660|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657661|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657662|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657663|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657664|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657665|NCT00385138|E2|Reported Event|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
657666|NCT00385138|E1|Reported Event|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
657667|NCT00385008|B3|Baseline|Total|Total of all reporting groups
657739|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657668|NCT00385008|B2|Baseline|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657669|NCT00385008|B1|Baseline|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657670|NCT00385008|P2|Participant Flow|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657671|NCT00385008|P1|Participant Flow|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 milliliter (mL) of water.
657672|NCT00385008|O2|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657673|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657674|NCT00385008|O2|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657675|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657676|NCT00385008|O2|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657677|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657678|NCT00385008|O2|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657679|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657740|NCT00384930|O3|Outcome|5.0 mg Tadalafil|5.0 mg tadalafil tablet by mouth once a day for twelve weeks
657741|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657680|NCT00385008|O1|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657681|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657682|NCT00385008|O1|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657683|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657684|NCT00385008|O1|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657685|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657686|NCT00385008|O2|Outcome|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657687|NCT00385008|O1|Outcome|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657688|NCT00385008|E2|Reported Event|Relpax (Eletriptan 40 mg)|Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657689|NCT00385008|E1|Reported Event|TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)|Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
657690|NCT00384956|B1|Baseline|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657691|NCT00384956|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657692|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657742|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657743|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657744|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657693|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657694|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657695|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657696|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657697|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657698|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657699|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657700|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657701|NCT00384956|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
657702|NCT00384930|B6|Baseline|Total|Total of all reporting groups
657703|NCT00384930|B5|Baseline|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657704|NCT00384930|B4|Baseline|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657705|NCT00384930|B3|Baseline|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657706|NCT00384930|B2|Baseline|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657707|NCT00384930|B1|Baseline|Placebo|placebo tablet by mouth once a day for twelve weeks
657708|NCT00384930|P5|Participant Flow|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657709|NCT00384930|P4|Participant Flow|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657710|NCT00384930|P3|Participant Flow|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657711|NCT00384930|P2|Participant Flow|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657712|NCT00384930|P1|Participant Flow|Placebo|placebo tablet by mouth once a day for twelve weeks
657713|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657714|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657715|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657716|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657717|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657718|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657719|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657720|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657721|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657722|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657723|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657724|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657725|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657726|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657727|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657728|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657729|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657730|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657731|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657732|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657733|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657734|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657746|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657747|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657748|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657749|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657750|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657751|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657752|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657753|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657754|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657755|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657756|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657757|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
657758|NCT00384930|O2|Outcome|5 mg Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
657759|NCT00384930|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
657760|NCT00384930|E5|Reported Event|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
657761|NCT00384930|E4|Reported Event|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
657762|NCT00384930|E3|Reported Event|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
657763|NCT00384930|E2|Reported Event|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
657764|NCT00384930|E1|Reported Event|Placebo|placebo tablet by mouth once a day for twelve weeks
657765|NCT00384865|B5|Baseline|Total|Total of all reporting groups
657766|NCT00384865|B4|Baseline|Placebo + Placebo|Placebo: Placebo, taken orally, once a day for 6 months
657767|NCT00384865|B3|Baseline|Placebo + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
657768|NCT00384865|B2|Baseline|Aspirin 81 mg + Placebo|"Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
657769|NCT00384865|B1|Baseline|Aspirin 81 mg + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months"
657770|NCT00384865|P4|Participant Flow|Placebo + Placebo|Placebo: Placebo, taken orally, once a day for 6 months
657771|NCT00384865|P3|Participant Flow|Placebo + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
657772|NCT00384865|P2|Participant Flow|Aspirin 81 mg + Placebo|"Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months~Placebo: Placebo, taken orally, once a day for 6 months"
657773|NCT00384865|P1|Participant Flow|Aspirin 81 mg + Simvastatin 40 mg|"Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months~Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months"
657774|NCT00384865|O4|Outcome|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
657775|NCT00384865|O3|Outcome|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
657776|NCT00384865|O2|Outcome|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
657777|NCT00384865|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
657778|NCT00384865|O4|Outcome|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
657779|NCT00384865|O3|Outcome|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
657780|NCT00384865|O2|Outcome|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
657781|NCT00384865|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
657782|NCT00384865|O4|Outcome|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
657783|NCT00384865|O3|Outcome|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
657784|NCT00384865|O2|Outcome|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
657785|NCT00384865|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
657786|NCT00384865|E4|Reported Event|Simvastatin Placebo|Placebo, taken orally, once a day for 6 months
657787|NCT00384865|E3|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg, taken orally, once a day for 6 months
657788|NCT00384865|E2|Reported Event|Aspirin Placebo|Placebo, taken orally, once a day for 6 months
657789|NCT00384865|E1|Reported Event|Aspirin 81 mg|Aspirin 81 mg, taken orally, once a day for 6 months
657790|NCT00384813|B3|Baseline|Total|Total of all reporting groups
657791|NCT00384813|B2|Baseline|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
657792|NCT00384813|B1|Baseline|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
657793|NCT00384813|P2|Participant Flow|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
657794|NCT00384813|P1|Participant Flow|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
657795|NCT00384813|O2|Outcome|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
657836|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
657796|NCT00384813|O1|Outcome|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
657797|NCT00384813|E2|Reported Event|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
657798|NCT00384813|E1|Reported Event|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
657799|NCT00384748|B3|Baseline|Total|Total of all reporting groups
657800|NCT00384748|B2|Baseline|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
657801|NCT00384748|B1|Baseline|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
657802|NCT00384748|P2|Participant Flow|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
657803|NCT00384748|P1|Participant Flow|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
657804|NCT00384748|O2|Outcome|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
657805|NCT00384748|O1|Outcome|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
657806|NCT00384748|E2|Reported Event|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
658118|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
657807|NCT00384748|E1|Reported Event|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
657808|NCT00384670|B1|Baseline|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657809|NCT00384670|P1|Participant Flow|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657810|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657811|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657812|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657813|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657814|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657815|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657816|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657817|NCT00384670|E1|Reported Event|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
657818|NCT00384397|B4|Baseline|Total|Total of all reporting groups
657819|NCT00384397|B3|Baseline|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
657820|NCT00384397|B2|Baseline|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
657821|NCT00384397|B1|Baseline|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
657822|NCT00384397|P3|Participant Flow|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
657823|NCT00384397|P2|Participant Flow|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
657824|NCT00384397|P1|Participant Flow|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
657825|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
657826|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
657827|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
657828|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
657829|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
657830|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
657831|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
657832|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
657833|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
657834|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
657835|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
667519|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
657837|NCT00384397|E3|Reported Event|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
657838|NCT00384397|E2|Reported Event|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
657839|NCT00384397|E1|Reported Event|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
657840|NCT00384332|B3|Baseline|Total|Total of all reporting groups
657841|NCT00384332|B2|Baseline|Arm 2|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
657842|NCT00384332|B1|Baseline|Arm 1|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
657843|NCT00384332|P2|Participant Flow|Arm 2- SOT|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
657844|NCT00384332|P1|Participant Flow|Arm 1- ODT|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
657845|NCT00384332|O2|Outcome|Arm 2|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
657846|NCT00384332|O1|Outcome|Arm 1|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
657847|NCT00384332|O2|Outcome|Arm 2- SOT|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
657848|NCT00384332|O1|Outcome|Arm 1- ODT|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
657849|NCT00384332|E2|Reported Event|Arm 2- SOT|"regular olanzapine~regular olanzapine: 5-20 mg. olanzapine daily for approximately 8 weeks."
657850|NCT00384332|E1|Reported Event|Arm 1- ODT|"Orally disintegrating olanzapine~orally-disintegrating olanzapine: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks."
657851|NCT00384293|B3|Baseline|Total|Total of all reporting groups
657852|NCT00384293|B2|Baseline|Placebo (Postrandomization Period)|Patients who were randomized to placebo
657853|NCT00384293|B1|Baseline|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
657854|NCT00384293|P3|Participant Flow|Placebo (Postrandomization Period)|Patients who were randomized to placebo
657855|NCT00384293|P2|Participant Flow|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
657856|NCT00384293|P1|Participant Flow|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
657857|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
657858|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
657859|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
657860|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
657861|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
657862|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
657863|NCT00384293|E3|Reported Event|Placebo (Postrandomization Period)|Patients who were randomized to placebo
657864|NCT00384293|E2|Reported Event|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
657865|NCT00384293|E1|Reported Event|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
657866|NCT00384241|B3|Baseline|Total|Total of all reporting groups
657867|NCT00384241|B2|Baseline|Parents|African American and Caucasian parents, age 18-65.
657868|NCT00384241|B1|Baseline|Children|African American and Caucasian children age 15-19.
657869|NCT00384241|P2|Participant Flow|Parents|Buccal swabs from the Parents of 500 subjects in the children arm were collected and analyzed for genetic variations. Some parents submitted duplicate swabs if more than 1 child was represented in the 500 subjects.
657870|NCT00384241|P1|Participant Flow|Children|Genotyping and IL-6 levels of 500 children enrolled in two previous studies were collected in the current study. Other phenotype data: Baseline blood pressure, stress blood pressure, and recovery blood pressure; Baseline stress and recovery urinary sodium excretion that were collected in two previous studies were utilized in the current study.
657871|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
657872|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
657873|NCT00384241|E2|Reported Event|Parents|African American and Caucasian parents age 18 - 65
657874|NCT00384241|E1|Reported Event|Children|African American and Caucasian children age 15 - 19.
657875|NCT00384189|B5|Baseline|Total|Total of all reporting groups
658055|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
657876|NCT00384189|B4|Baseline|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657877|NCT00384189|B3|Baseline|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657878|NCT00384189|B2|Baseline|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657879|NCT00384189|B1|Baseline|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657880|NCT00384189|P4|Participant Flow|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657881|NCT00384189|P3|Participant Flow|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657882|NCT00384189|P2|Participant Flow|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657883|NCT00384189|P1|Participant Flow|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657884|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657885|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657886|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657887|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657888|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657889|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657890|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657891|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657892|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657893|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
658119|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
667520|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
657894|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657895|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657896|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657897|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657898|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657899|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657900|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657901|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657902|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657903|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657904|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657905|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657906|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657907|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657908|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657909|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657910|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657911|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
658120|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
667521|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
657912|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657913|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657914|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657915|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657916|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657917|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657918|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657919|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657920|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657921|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657922|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657923|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657924|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657925|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657926|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657927|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657928|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657929|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
658121|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
658122|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
657930|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657931|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657932|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657933|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657934|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657935|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657936|NCT00384189|E4|Reported Event|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657937|NCT00384189|E3|Reported Event|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657938|NCT00384189|E2|Reported Event|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657939|NCT00384189|E1|Reported Event|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
657940|NCT00384176|B4|Baseline|Total|Total of all reporting groups
657941|NCT00384176|B3|Baseline|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657942|NCT00384176|B2|Baseline|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657943|NCT00384176|B1|Baseline|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657944|NCT00384176|P3|Participant Flow|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657945|NCT00384176|P2|Participant Flow|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657946|NCT00384176|P1|Participant Flow|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
658057|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658272|NCT00383552|E3|Reported Event|MF MDI 100 MCG BID|
657947|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657948|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657949|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657950|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657951|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657952|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657953|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657954|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657955|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657956|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657957|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657958|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657959|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657960|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657961|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
658113|NCT00383760|B1|Baseline|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: 1.4mg/m2 given IV weekly day 1,8 every 21 days (1 cycle)."
657962|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657963|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657964|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657965|NCT00384176|E3|Reported Event|1Bevacizumab 5mg/kg|Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
657966|NCT00384176|E2|Reported Event|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657967|NCT00384176|E1|Reported Event|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
657968|NCT00384085|B4|Baseline|Total|Total of all reporting groups
657969|NCT00384085|B3|Baseline|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657970|NCT00384085|B2|Baseline|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657971|NCT00384085|B1|Baseline|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657972|NCT00384085|P3|Participant Flow|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657973|NCT00384085|P2|Participant Flow|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657974|NCT00384085|P1|Participant Flow|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657975|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657976|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657977|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657978|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657979|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657980|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657981|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657982|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657983|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657984|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657985|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657986|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657987|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657988|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657989|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657990|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657991|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657992|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657993|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657994|NCT00384085|E3|Reported Event|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
657995|NCT00384085|E2|Reported Event|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
657996|NCT00384085|E1|Reported Event|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
657997|NCT00384059|B3|Baseline|Total|Total of all reporting groups
658056|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658114|NCT00383760|P1|Participant Flow|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
657998|NCT00384059|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
657999|NCT00384059|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658000|NCT00384059|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658001|NCT00384059|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658002|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658003|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658004|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
658005|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
658006|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
658007|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
658008|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
658009|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
658010|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
658011|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
658012|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
658013|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
658014|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
658015|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
658016|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
658017|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
658018|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
658019|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
658020|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
658021|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
658022|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658023|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658024|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658025|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658026|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658027|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658028|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658029|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658030|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658031|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658032|NCT00384059|O4|Outcome|7vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
658033|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
658034|NCT00384059|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
658035|NCT00384059|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
658036|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658037|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658038|NCT00384059|E8|Reported Event|7vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
658039|NCT00384059|E7|Reported Event|13vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) & Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
658040|NCT00384059|E6|Reported Event|7vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658041|NCT00384059|E5|Reported Event|13vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
658042|NCT00384059|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
658043|NCT00384059|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
658044|NCT00384059|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
658045|NCT00384059|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
658046|NCT00384033|B5|Baseline|Total|Total of all reporting groups
658047|NCT00384033|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658048|NCT00384033|B3|Baseline|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658049|NCT00384033|B2|Baseline|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658050|NCT00384033|B1|Baseline|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658051|NCT00384033|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658052|NCT00384033|P3|Participant Flow|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658053|NCT00384033|P2|Participant Flow|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658054|NCT00384033|P1|Participant Flow|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658058|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658059|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658060|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658061|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658062|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658063|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658064|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658065|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658066|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658067|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658068|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658069|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658070|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658071|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658072|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658073|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658074|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658075|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658076|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658077|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658078|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658079|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658080|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658081|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658082|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658083|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658084|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658085|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658086|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658087|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658088|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658089|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658090|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658091|NCT00384033|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
658092|NCT00384033|E3|Reported Event|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658093|NCT00384033|E2|Reported Event|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658094|NCT00384033|E1|Reported Event|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
658095|NCT00383942|B3|Baseline|Total|Total of all reporting groups
658096|NCT00383942|B2|Baseline|EASI|Patients randomized to this arm receive extra amniotic saline infusion via a catheter that is placed in the uterus
658097|NCT00383942|B1|Baseline|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
658098|NCT00383942|P2|Participant Flow|EASI|Patients randomized to this arm receive an extra amniotic saline infusion via catheter that is placed in the uterus
658099|NCT00383942|P1|Participant Flow|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
658100|NCT00383942|O2|Outcome|EASI|Patients randomized to this arm recieve extra amniotic saline infusion (EASI) via a catheter that is placed in the uterus
658101|NCT00383942|O1|Outcome|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
658102|NCT00383942|E2|Reported Event|EASI|Patients assigned to this arm received extra amniotic saline infusion via a catheter that is placed in the uterus
658103|NCT00383942|E1|Reported Event|Misoprostol|Patients assigned to this arm received 25 micrograms of misoprostol every 4 hours
658104|NCT00383786|B3|Baseline|Total|Total of all reporting groups
658105|NCT00383786|B2|Baseline|Placebo|sugar pill
658106|NCT00383786|B1|Baseline|GR205171|selective neurokinin-1 receptor antagonist
658107|NCT00383786|P2|Participant Flow|Placebo|sugar pill administered daily for a period of 8 weeks
658108|NCT00383786|P1|Participant Flow|GR205171|selective neurokinin-1 receptor antagonist, 5mg/day for a period of 8 weeks
658109|NCT00383786|O2|Outcome|Placebo|
658110|NCT00383786|O1|Outcome|GR205171|
658111|NCT00383786|E2|Reported Event|Placebo|sugar pill
658112|NCT00383786|E1|Reported Event|GR205171|selective neurokinin-1 receptor antagonist
658115|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
658123|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
658124|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
658125|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
658126|NCT00383760|E1|Reported Event|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
658127|NCT00383747|B3|Baseline|Total|Total of all reporting groups
658128|NCT00383747|B2|Baseline|Controls|
658129|NCT00383747|B1|Baseline|Non Smokers With Schizophrenia|
658130|NCT00383747|P4|Participant Flow|Controls: Placebo (V1) Then Nicotine Patch (V2)|Non-smoking adults without psychiatric illness received placebo patch then nicotine patch 14mg transdermal nicotine application
658131|NCT00383747|P3|Participant Flow|Controls: Nicotine Patch (V1) Then Placebo (V2)|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
658132|NCT00383747|P2|Participant Flow|Nonsmokers w/Schizophr: Placebo (V1) Then Nicotine Patch (V2)|Non smokers with schizophrenia received Placebo patch application then Nicotine patch: 14mg transdermal nicotine
658133|NCT00383747|P1|Participant Flow|Non-smokers w/Schizophr: Nicotine Patch (V1) Then Placebo (V2)|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
658134|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
658135|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
658136|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia + Placebo|Non smokers with schizophrenia received Placebo patch application
658137|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
658138|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
658139|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
658140|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia + Placebo|Non smokers with schizophrenia received Placebo patch application
658141|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
658142|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
658143|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
658144|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia +, Placebo|Non smokers with schizophrenia received Placebo patch application
658145|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
658146|NCT00383747|O4|Outcome|Controls + Placebo Nicotine Patch|Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
658147|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
658148|NCT00383747|O2|Outcome|Non Smokers With Schizophrenia + Placebo Nicotine Patch|Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
658149|NCT00383747|O1|Outcome|Non Smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
658150|NCT00383747|E2|Reported Event|Controls|
658151|NCT00383747|E1|Reported Event|Non Smokers With Schizophrenia|
658152|NCT00383721|B6|Baseline|Total|Total of all reporting groups
658153|NCT00383721|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks.
658154|NCT00383721|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658155|NCT00383721|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658156|NCT00383721|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658157|NCT00383721|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658158|NCT00383721|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks.
658159|NCT00383721|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658160|NCT00383721|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658161|NCT00383721|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658162|NCT00383721|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658163|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
658164|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658165|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658166|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658167|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658168|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
658169|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658170|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658171|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658172|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658173|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
658174|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658175|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658176|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658177|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658178|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
658179|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658180|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658181|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658182|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658183|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
658184|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658185|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658186|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658187|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658188|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
658189|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658190|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658191|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658192|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658193|NCT00383721|E5|Reported Event|Placebo|Placebo MDI BID for 26 weeks.
658194|NCT00383721|E4|Reported Event|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
658195|NCT00383721|E3|Reported Event|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
658196|NCT00383721|E2|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
658197|NCT00383721|E1|Reported Event|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
658198|NCT00383643|B4|Baseline|Total|Total of all reporting groups
658199|NCT00383643|B3|Baseline|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658200|NCT00383643|B2|Baseline|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658201|NCT00383643|B1|Baseline|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658202|NCT00383643|P3|Participant Flow|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658203|NCT00383643|P2|Participant Flow|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658204|NCT00383643|P1|Participant Flow|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658205|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658206|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658207|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658208|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658209|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658210|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658211|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658212|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658213|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658214|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658215|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658216|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658217|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658273|NCT00383552|E2|Reported Event|MF/F MDI 100/10 MCG BID|
658218|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658219|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658220|NCT00383643|E3|Reported Event|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
658221|NCT00383643|E2|Reported Event|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
658222|NCT00383643|E1|Reported Event|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
658223|NCT00383565|B1|Baseline|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
658224|NCT00383565|P1|Participant Flow|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
658225|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
658226|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
658227|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
658228|NCT00383565|E1|Reported Event|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
658229|NCT00383552|B5|Baseline|Total|Total of all reporting groups
658230|NCT00383552|B4|Baseline|Placebo BID|Placebo twice daily (BID)
658231|NCT00383552|B3|Baseline|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658232|NCT00383552|B2|Baseline|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658233|NCT00383552|B1|Baseline|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658234|NCT00383552|P4|Participant Flow|Placebo BID|Placebo twice daily (BID)
658235|NCT00383552|P3|Participant Flow|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658236|NCT00383552|P2|Participant Flow|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658237|NCT00383552|P1|Participant Flow|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658238|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
658239|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658240|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658241|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658242|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
658243|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658244|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658245|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658246|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
658247|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658248|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658249|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658250|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
658251|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658252|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658253|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658254|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
658255|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658256|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658257|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658258|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID).
658259|NCT00383552|O3|Outcome|F MDI 10 Mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID).
658260|NCT00383552|O2|Outcome|MF MDI 100 Mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID).
658261|NCT00383552|O1|Outcome|MF/F MDI 100/10 Mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID).
658262|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
658263|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658264|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658265|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658266|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
658267|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
658268|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
658269|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
658270|NCT00383552|E5|Reported Event|PLACEBO|
658271|NCT00383552|E4|Reported Event|F MDI 10 MCG BID|
658274|NCT00383552|E1|Reported Event|OL MF MDI 100 MCG BID|Open-label (OL) mometasone furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID). Participants received 2- to 3-weeks (approximately) of open-label run-in with MF MDI 100 mcg BID prior to the 26-week double-blind Treatment Period.
658275|NCT00383500|B4|Baseline|Total|Total of all reporting groups
658276|NCT00383500|B3|Baseline|Group III|This is the control group; they will receive no treatment
658277|NCT00383500|B2|Baseline|Group II|This group of patients will receive prophylactic MLD
658278|NCT00383500|B1|Baseline|Group I|This group of patients will receive the device.
658279|NCT00383500|P3|Participant Flow|No Intervention Control|No intervention observational control
658280|NCT00383500|P2|Participant Flow|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
658281|NCT00383500|P1|Participant Flow|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
658282|NCT00383500|O3|Outcome|No Intervention Control|No intervention observational control
658283|NCT00383500|O2|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
658284|NCT00383500|O1|Outcome|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
658285|NCT00383500|O3|Outcome|No Intervention Control|No intervention observational control
658286|NCT00383500|O2|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic drainage therapy
658287|NCT00383500|O1|Outcome|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
658288|NCT00383500|E3|Reported Event|Observational Control (no Intervention)|Control group, no intervention. No Flexitouch or manual massage therapy
658289|NCT00383500|E2|Reported Event|Manual Lymphatic Drainage (MLD)|Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment.
658290|NCT00383500|E1|Reported Event|Flexitouch Device|Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
658291|NCT00383435|B6|Baseline|Total|Total of all reporting groups
658292|NCT00383435|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks
658293|NCT00383435|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658294|NCT00383435|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658295|NCT00383435|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658296|NCT00383435|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658297|NCT00383435|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks
658298|NCT00383435|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658299|NCT00383435|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658300|NCT00383435|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658301|NCT00383435|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658302|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
658303|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658304|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658305|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658306|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658307|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
658308|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658309|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658310|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658311|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658312|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
658313|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658314|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658315|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658316|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658317|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
658318|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658319|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658320|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658321|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658322|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
658323|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658324|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658325|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658326|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658327|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
658328|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
658329|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
658330|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
658331|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
658332|NCT00383435|E5|Reported Event|PLACEBO|
658333|NCT00383435|E4|Reported Event|F MDI 10 MCG BID|
658334|NCT00383435|E3|Reported Event|MF MDI 400 MCG BID|
658335|NCT00383435|E2|Reported Event|MF/F MDI 400/10 MCG BID|
658336|NCT00383435|E1|Reported Event|MF/F MDI 200/10 MCG BID|
658337|NCT00383331|B3|Baseline|Total|Total of all reporting groups
658338|NCT00383331|B2|Baseline|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658339|NCT00383331|B1|Baseline|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658340|NCT00383331|P2|Participant Flow|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658341|NCT00383331|P1|Participant Flow|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658342|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658343|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658344|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658345|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658346|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658347|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658348|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658349|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658350|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658351|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658352|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658353|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658354|NCT00383331|E2|Reported Event|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
658355|NCT00383331|E1|Reported Event|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
658356|NCT00383266|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658357|NCT00383266|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658358|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658359|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658360|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658361|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658362|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658363|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658364|NCT00383266|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
658365|NCT00383240|B5|Baseline|Total|Total of all reporting groups
658366|NCT00383240|B4|Baseline|Placebo BID|Placebo MDI BID for 26 weeks
658367|NCT00383240|B3|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658368|NCT00383240|B2|Baseline|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658369|NCT00383240|B1|Baseline|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658370|NCT00383240|P4|Participant Flow|Placebo BID|Placebo MDI BID for 26 weeks
658371|NCT00383240|P3|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658372|NCT00383240|P2|Participant Flow|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658373|NCT00383240|P1|Participant Flow|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658374|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
658375|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658376|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658377|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658378|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
658379|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658380|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658381|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658382|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
658383|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658384|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658385|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658386|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
658387|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658388|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658389|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658390|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
658391|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658392|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658393|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658394|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
658395|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
658396|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
658397|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
658398|NCT00383240|E5|Reported Event|PLACEBO|
658399|NCT00383240|E4|Reported Event|F MDI 10 MCG BID|
658400|NCT00383240|E3|Reported Event|MF MDI 200 MCG BID|
658401|NCT00383240|E2|Reported Event|MF/F MDI 200/10 MCG BID|
658402|NCT00383240|E1|Reported Event|OL MF MDI 200 MCG BID|Participants received 2 to 3 weeks (approximately) of open-label (OL), run-in medication with MF MDI 200 mcg BID prior to the 26-week double-blind treatment period.
658403|NCT00383162|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
658404|NCT00383162|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
658405|NCT00383162|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
658406|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658407|NCT00383162|O1|Outcome|Placebo|
658408|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658409|NCT00383162|O1|Outcome|Placebo|
658410|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658411|NCT00383162|O1|Outcome|Placebo|
658412|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658413|NCT00383162|O1|Outcome|Placebo|
658414|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658415|NCT00383162|O1|Outcome|Placebo|
658416|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658417|NCT00383162|O1|Outcome|Placebo|
658418|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658419|NCT00383162|O1|Outcome|Placebo|
658420|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658421|NCT00383162|O1|Outcome|Placebo|
658422|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658423|NCT00383162|O1|Outcome|Placebo|
658424|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658425|NCT00383162|O1|Outcome|Placebo|
658426|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658427|NCT00383162|O1|Outcome|Placebo|
658428|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658429|NCT00383162|O1|Outcome|Placebo|
658430|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658431|NCT00383162|O1|Outcome|Placebo|
658432|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658433|NCT00383162|O1|Outcome|Placebo|
658434|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658435|NCT00383162|O1|Outcome|Placebo|
658436|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658437|NCT00383162|O1|Outcome|Placebo|
658438|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658439|NCT00383162|O1|Outcome|Placebo|
658440|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658441|NCT00383162|O1|Outcome|Placebo|
658442|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
658443|NCT00383162|O1|Outcome|Placebo|
658444|NCT00383162|E2|Reported Event|Sumatriptan-Naproxen Sodium|Subjects who were randomized to take Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 1, then a one week wash-out period without any drugs, and then given Placebo during Migraine period 2.
658445|NCT00383162|E1|Reported Event|Placebo|Subjects who were randomized to take Placebo during Migraine period 1, then a one week wash-out period without any drugs, and then given Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 2.
658446|NCT00383149|B1|Baseline|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658447|NCT00383149|P1|Participant Flow|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658448|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658449|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658450|NCT00383149|O2|Outcome|Cetuximab|All participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658451|NCT00383149|O1|Outcome|Ixabepilone|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks.
658452|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658453|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658454|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658455|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658456|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658457|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658458|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658459|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658460|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658461|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658462|NCT00383149|E1|Reported Event|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
658463|NCT00383123|B3|Baseline|Total|Total of all reporting groups
658464|NCT00383123|B2|Baseline|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658465|NCT00383123|B1|Baseline|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658466|NCT00383123|P2|Participant Flow|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658467|NCT00383123|P1|Participant Flow|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658468|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658469|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658470|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658471|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658472|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658473|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658474|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658475|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658476|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658477|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658478|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658479|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658480|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658481|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658482|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658483|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658484|NCT00383123|E2|Reported Event|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658485|NCT00383123|E1|Reported Event|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
658486|NCT00383110|B3|Baseline|Total|Total of all reporting groups
658487|NCT00383110|B2|Baseline|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
658488|NCT00383110|B1|Baseline|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658489|NCT00383110|P2|Participant Flow|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
658490|NCT00383110|P1|Participant Flow|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658491|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658492|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658493|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658494|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658495|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658496|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658497|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658498|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658499|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
658500|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658501|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
658502|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658503|NCT00383110|E2|Reported Event|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
658504|NCT00383110|E1|Reported Event|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
658505|NCT00383084|B3|Baseline|Total|Total of all reporting groups
658506|NCT00383084|B2|Baseline|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
658507|NCT00383084|B1|Baseline|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
658508|NCT00383084|P2|Participant Flow|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
658509|NCT00383084|P1|Participant Flow|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
658510|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
658511|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
658512|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
658554|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658681|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658513|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
658514|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
658515|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
658516|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
658517|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
658518|NCT00383084|E2|Reported Event|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
658519|NCT00383084|E1|Reported Event|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
658520|NCT00383071|B5|Baseline|Total|Total of all reporting groups
658521|NCT00383071|B4|Baseline|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
658522|NCT00383071|B3|Baseline|180 mcg Cohort 4|180 mcg IM every 4 weeks for 2 vaccinations
658523|NCT00383071|B2|Baseline|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
658524|NCT00383071|B1|Baseline|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
658525|NCT00383071|P4|Participant Flow|Cohort 1: 90 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
658526|NCT00383071|P3|Participant Flow|Cohort 4: 180 mcg|120 mcg every 28 days x 2 doses. Subjects randomized to receive vaccination in arm or buttock.
658527|NCT00383071|P2|Participant Flow|Cohort 3: 180 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
658528|NCT00383071|P1|Participant Flow|Cohort 2: 120 mcg|120 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
658529|NCT00383071|O4|Outcome|180 mcg Cohort 4|120 mcg IM every 4 weeks for 2 vaccinations
658530|NCT00383071|O3|Outcome|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
658531|NCT00383071|O2|Outcome|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
658532|NCT00383071|O1|Outcome|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
658533|NCT00383071|E4|Reported Event|90 mcg|90 mcg every 28 days x 4 doses
658534|NCT00383071|E3|Reported Event|180 mcg Cohort 4|180 mcg every 28 days x 2 doses
658535|NCT00383071|E2|Reported Event|180 mcg|180 mcg every 28 days x 4 doses
658536|NCT00383071|E1|Reported Event|120 mcg|120 mcg every 28 days x 4 doses
658537|NCT00383019|B3|Baseline|Total|Total of all reporting groups
658538|NCT00383019|B2|Baseline|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658539|NCT00383019|B1|Baseline|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658540|NCT00383019|P2|Participant Flow|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658541|NCT00383019|P1|Participant Flow|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658542|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658543|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658544|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658545|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658546|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658547|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658548|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658549|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658550|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658551|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658552|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658553|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658682|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658555|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658556|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658557|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658558|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658559|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658560|NCT00383019|E2|Reported Event|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
658561|NCT00383019|E1|Reported Event|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
658562|NCT00382993|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
658563|NCT00382993|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
658564|NCT00382993|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
658565|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658566|NCT00382993|O1|Outcome|Placebo|
658567|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658568|NCT00382993|O1|Outcome|Placebo|
658569|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658570|NCT00382993|O1|Outcome|Placebo|
658571|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658572|NCT00382993|O1|Outcome|Placebo|
658573|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658574|NCT00382993|O1|Outcome|Placebo|
658575|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658576|NCT00382993|O1|Outcome|Placebo|
658577|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658578|NCT00382993|O1|Outcome|Placebo|
658579|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658580|NCT00382993|O1|Outcome|Placebo|
658581|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658582|NCT00382993|O1|Outcome|Placebo|
658583|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658584|NCT00382993|O1|Outcome|Placebo|
658585|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658586|NCT00382993|O1|Outcome|Placebo|
658587|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658588|NCT00382993|O1|Outcome|Placebo|
658589|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658590|NCT00382993|O1|Outcome|Placebo|
658591|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658592|NCT00382993|O1|Outcome|Placebo|
658593|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658594|NCT00382993|O1|Outcome|Placebo|
658595|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658596|NCT00382993|O1|Outcome|Placebo|
658597|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658598|NCT00382993|O1|Outcome|Placebo|
658599|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658600|NCT00382993|O1|Outcome|Placebo|
658601|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
658602|NCT00382993|O1|Outcome|Placebo|
658603|NCT00382993|E2|Reported Event|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
658604|NCT00382993|E1|Reported Event|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
658605|NCT00382967|B3|Baseline|Total|Total of all reporting groups
658606|NCT00382967|B2|Baseline|Control Arm|No (Injection) Intervention
658607|NCT00382967|B1|Baseline|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
658608|NCT00382967|P2|Participant Flow|Control Arm|No (Injection) Intervention
658609|NCT00382967|P1|Participant Flow|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
658610|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
658611|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
658612|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
658613|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
658614|NCT00382967|E2|Reported Event|Control Arm|No (Injection) Intervention
658615|NCT00382967|E1|Reported Event|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
658616|NCT00382928|B3|Baseline|Total|Total of all reporting groups
658617|NCT00382928|B2|Baseline|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
658618|NCT00382928|B1|Baseline|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
658679|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658680|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658619|NCT00382928|P2|Participant Flow|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
658620|NCT00382928|P1|Participant Flow|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention
658621|NCT00382928|O2|Outcome|Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
658622|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
658623|NCT00382928|O2|Outcome|No Intervention: Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
658624|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
658625|NCT00382928|O2|Outcome|Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
658626|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
658627|NCT00382928|O2|Outcome|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
658628|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Stand of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
658629|NCT00382928|E2|Reported Event|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
658630|NCT00382928|E1|Reported Event|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
658631|NCT00382863|B3|Baseline|Total|Total of all reporting groups
658632|NCT00382863|B2|Baseline|Control|Optimal Medical/Device Therapy alone
658633|NCT00382863|B1|Baseline|Treatment|HeartNet and Optimal Medical/Device Therapy
658634|NCT00382863|P2|Participant Flow|Control|Optimal Medical/Device Therapy alone
658635|NCT00382863|P1|Participant Flow|Treatment|HeartNet and Optimal Medical/Device Therapy
658636|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658637|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658638|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658639|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658640|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658641|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658642|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658643|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658644|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658645|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658646|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658647|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658648|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658649|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658650|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658651|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658652|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658653|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658654|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658655|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658656|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658657|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658658|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658659|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658660|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658661|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658662|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658663|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658664|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658665|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658666|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658667|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658668|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658669|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658670|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658671|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658672|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658673|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658674|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658675|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658676|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658677|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658678|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658683|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658684|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
658685|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
658686|NCT00382863|E2|Reported Event|Control|Optimal Medical/Device Therapy alone
658687|NCT00382863|E1|Reported Event|Treatment|HeartNet and Optimal Medical/Device Therapy
658688|NCT00382785|B3|Baseline|Total|Total of all reporting groups
658689|NCT00382785|B2|Baseline|Non-facilitated (Peer-led)|12-week online support in a peer-led format
658690|NCT00382785|B1|Baseline|Moderated Group|one 12-week online support group led by a professional healthcare provider
658691|NCT00382785|P2|Participant Flow|Non-facilitated (Peer-led)|12-week online support in a peer-led format
658692|NCT00382785|P1|Participant Flow|Moderated Group|one 12-week online support group led by a professional healthcare provider
658693|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
658694|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
658695|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
658696|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
658697|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
658698|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
658699|NCT00382785|E2|Reported Event|Peer-led|peer-led group
658700|NCT00382785|E1|Reported Event|Moderated|
658701|NCT00382733|B1|Baseline|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
658702|NCT00382733|P5|Participant Flow|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
658703|NCT00382733|P4|Participant Flow|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
658704|NCT00382733|P3|Participant Flow|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
658705|NCT00382733|P2|Participant Flow|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
658706|NCT00382733|P1|Participant Flow|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
658707|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
658708|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
658709|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
658710|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
658711|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
658712|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
658713|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
658714|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
658715|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
658716|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
658717|NCT00382733|O1|Outcome|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
658718|NCT00382733|E5|Reported Event|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
658719|NCT00382733|E4|Reported Event|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
658720|NCT00382733|E3|Reported Event|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
658721|NCT00382733|E2|Reported Event|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
658722|NCT00382733|E1|Reported Event|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
658723|NCT00382720|B4|Baseline|Total|Total of all reporting groups
658724|NCT00382720|B3|Baseline|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
658725|NCT00382720|B2|Baseline|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
658726|NCT00382720|B1|Baseline|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
658727|NCT00382720|P3|Participant Flow|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
667522|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
658728|NCT00382720|P2|Participant Flow|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
658729|NCT00382720|P1|Participant Flow|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
658730|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
658731|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
658732|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
658733|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
658734|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
658735|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
658736|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
658737|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
658738|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
658739|NCT00382720|E3|Reported Event|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
658740|NCT00382720|E2|Reported Event|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
658741|NCT00382720|E1|Reported Event|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
658742|NCT00382590|B3|Baseline|Total|Total of all reporting groups
658743|NCT00382590|B2|Baseline|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
658744|NCT00382590|B1|Baseline|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
658745|NCT00382590|P2|Participant Flow|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
658746|NCT00382590|P1|Participant Flow|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
658747|NCT00382590|O2|Outcome|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
658748|NCT00382590|O1|Outcome|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
658749|NCT00382590|E2|Reported Event|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
658750|NCT00382590|E1|Reported Event|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
658751|NCT00382408|B3|Baseline|Total|Total of all reporting groups
658752|NCT00382408|B2|Baseline|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658753|NCT00382408|B1|Baseline|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658754|NCT00382408|P2|Participant Flow|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658755|NCT00382408|P1|Participant Flow|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658756|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658757|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658758|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658759|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658804|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
658760|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658761|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658762|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658763|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658764|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658765|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658766|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658767|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658768|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658769|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658770|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658771|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658772|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658773|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658774|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658775|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658776|NCT00382408|E2|Reported Event|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658777|NCT00382408|E1|Reported Event|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
658778|NCT00382291|B4|Baseline|Total|Total of all reporting groups
658779|NCT00382291|B3|Baseline|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
658780|NCT00382291|B2|Baseline|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
658781|NCT00382291|B1|Baseline|Placebo|Placebo plus cognitive behavior therapy.
658782|NCT00382291|P3|Participant Flow|Slow Sertraline Titration Plus CBT|Slow titration of sertraline (SloSert)plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
658783|NCT00382291|P2|Participant Flow|Regular Sertraline Titration Plus CBT|Regular titration of sertraline (RegSert) plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
658784|NCT00382291|P1|Participant Flow|Placebo Plus CBT|Placebo plus cognitive behavior therapy (CBT).
658785|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
658786|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
658787|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
658788|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
658789|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
658790|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
658791|NCT00382291|E3|Reported Event|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
658792|NCT00382291|E2|Reported Event|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
658793|NCT00382291|E1|Reported Event|Placebo|Placebo plus cognitive behavior therapy.
658794|NCT00382174|B3|Baseline|Total|Total of all reporting groups
658795|NCT00382174|B2|Baseline|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
658796|NCT00382174|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
658797|NCT00382174|P3|Participant Flow|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
658798|NCT00382174|P2|Participant Flow|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
658799|NCT00382174|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
658800|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
658801|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
658802|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
658803|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
658805|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
658806|NCT00382174|E3|Reported Event|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
658807|NCT00382174|E2|Reported Event|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
658808|NCT00382174|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
658809|NCT00382148|B3|Baseline|Total|Total of all reporting groups
658810|NCT00382148|B2|Baseline|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658811|NCT00382148|B1|Baseline|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658812|NCT00382148|P2|Participant Flow|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658813|NCT00382148|P1|Participant Flow|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658814|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658815|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658816|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658817|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658818|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658819|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658820|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658821|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658822|NCT00382148|E2|Reported Event|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658823|NCT00382148|E1|Reported Event|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
658824|NCT00382109|B3|Baseline|Total|Total of all reporting groups
658825|NCT00382109|B2|Baseline|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
658826|NCT00382109|B1|Baseline|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
658827|NCT00382109|P2|Participant Flow|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
658828|NCT00382109|P1|Participant Flow|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
658829|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
658830|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
658831|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse pre transplantation (MRD)
658832|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse post transplantation (correlating development of aGVHD with relapse).
658833|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
658834|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
658835|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
658836|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
658837|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
658838|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
658839|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
658840|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
658841|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
658842|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
658843|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
658844|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
658845|NCT00382109|E2|Reported Event|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
658846|NCT00382109|E1|Reported Event|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
658847|NCT00382031|B3|Baseline|Total|Total of all reporting groups
658848|NCT00382031|B2|Baseline|Control|Best Supportive Care
658849|NCT00382031|B1|Baseline|Zalutumumab|Zalutumumab in combination with Best Supportive Care
658850|NCT00382031|P2|Participant Flow|Control|Best Supportive Care
658851|NCT00382031|P1|Participant Flow|Zalutumumab|Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed.
658852|NCT00382031|O2|Outcome|Control|Best Supportive Care
658853|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
658854|NCT00382031|O2|Outcome|Control|Best Supportive Care
658855|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
658856|NCT00382031|O2|Outcome|Control|Best Supportive Care
658857|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
658858|NCT00382031|O2|Outcome|Control|Best Supportive Care
658859|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
658860|NCT00382031|E2|Reported Event|Control|Best Supportive Care
658861|NCT00382031|E1|Reported Event|Zalutumumab|Zalutumumab in combination with Best Supportive Care
658862|NCT00382018|B5|Baseline|Total|Total of all reporting groups
658863|NCT00382018|B4|Baseline|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
658864|NCT00382018|B3|Baseline|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
658865|NCT00382018|B2|Baseline|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
658866|NCT00382018|B1|Baseline|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
658867|NCT00382018|P4|Participant Flow|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
658868|NCT00382018|P3|Participant Flow|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
658869|NCT00382018|P2|Participant Flow|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
658891|NCT00381888|B1|Baseline|Patients Enrolled and Consented|This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.
658870|NCT00382018|P1|Participant Flow|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
658871|NCT00382018|O3|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
658872|NCT00382018|O2|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
658873|NCT00382018|O1|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
658874|NCT00382018|O3|Outcome|Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
658875|NCT00382018|O2|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
658876|NCT00382018|O1|Outcome|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
658877|NCT00382018|O3|Outcome|Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
658878|NCT00382018|O2|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
658879|NCT00382018|O1|Outcome|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
658880|NCT00382018|O2|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
658881|NCT00382018|O1|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
658882|NCT00382018|O2|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
658883|NCT00382018|O1|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
658884|NCT00382018|E3|Reported Event|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
658885|NCT00382018|E2|Reported Event|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
658886|NCT00382018|E1|Reported Event|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
658887|NCT00381940|B1|Baseline|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
658888|NCT00381940|P1|Participant Flow|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
658889|NCT00381940|O1|Outcome|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
658890|NCT00381940|E1|Reported Event|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
658892|NCT00381888|P1|Participant Flow|Patients Enrolled and Consented|This number includes all patients consented and enrolled in this study.
658893|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
658894|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
658895|NCT00381888|E1|Reported Event|All Patients Who Received at Least One Dose of Fondaparinux|This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
658896|NCT00381862|B1|Baseline|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
658897|NCT00381862|P1|Participant Flow|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
658898|NCT00381862|O1|Outcome|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
658899|NCT00381862|E1|Reported Event|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
658900|NCT00381849|B3|Baseline|Total|Total of all reporting groups
658901|NCT00381849|B2|Baseline|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658902|NCT00381849|B1|Baseline|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658903|NCT00381849|P2|Participant Flow|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658904|NCT00381849|P1|Participant Flow|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658905|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658906|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658907|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658908|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658909|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658910|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658911|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658912|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658913|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658914|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658915|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658916|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658917|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658918|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658919|NCT00381849|E2|Reported Event|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
658920|NCT00381849|E1|Reported Event|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
658921|NCT00381810|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
658922|NCT00381810|P1|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
658923|NCT00381810|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
658924|NCT00381810|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
658925|NCT00381797|B6|Baseline|Total|Total of all reporting groups
658926|NCT00381797|B5|Baseline|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658927|NCT00381797|B4|Baseline|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659513|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
658928|NCT00381797|B3|Baseline|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658929|NCT00381797|B2|Baseline|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658930|NCT00381797|B1|Baseline|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658931|NCT00381797|P5|Participant Flow|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658932|NCT00381797|P4|Participant Flow|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658933|NCT00381797|P3|Participant Flow|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658934|NCT00381797|P2|Participant Flow|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658935|NCT00381797|P1|Participant Flow|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659060|NCT00381641|B2|Baseline|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
658936|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658937|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658938|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658939|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658940|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658941|NCT00381797|O2|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658942|NCT00381797|O1|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658943|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659061|NCT00381641|B1|Baseline|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659174|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
658944|NCT00381797|O2|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658945|NCT00381797|O1|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658946|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658947|NCT00381797|O2|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658948|NCT00381797|O1|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658949|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658950|NCT00381797|O2|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658951|NCT00381797|O1|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659062|NCT00381641|P2|Participant Flow|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659170|NCT00381485|P1|Participant Flow|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
658952|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658953|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658954|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658955|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658956|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658957|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658958|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658959|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659171|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
659172|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
658960|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658961|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658962|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658963|NCT00381797|O1|Outcome|Combined All Strata|High-grade Gliomas(stratum A), Medulloblastoma (stratum B), Brain Stem Tumors (stratum C), Ependymoma (stratum D), and Low Grade Glioma (stratum E) were combined for this secondary objective.
658964|NCT00381797|O1|Outcome|Combined All Strata|High-grade Gliomas(stratum A), Medulloblastoma (stratum B), Brain Stem Tumors (stratum C), Ependymoma (stratum D), and Low Grade Glioma (stratum E) were combined for this secondary objective.
658965|NCT00381797|O1|Outcome|Combined All Strata|High-grade Gliomas(stratum A), Medulloblastoma (stratum B), Brain Stem Tumors (stratum C), Ependymoma (stratum D), and Low Grade Glioma (stratum E) were combined for this secondary objective.
658966|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658967|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658968|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658969|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659063|NCT00381641|P1|Participant Flow|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
667523|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
658970|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658971|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658972|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent,progressive or refractory instrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658973|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658974|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658975|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658976|NCT00381797|O4|Outcome|Low Grade Glioma|Recurrent low grade glioma(Stratum E):The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658977|NCT00381797|O3|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659064|NCT00381641|O2|Outcome|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
658978|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658979|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658980|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658981|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory Brain Stem Tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658982|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658983|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent, progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658984|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with Recurrent or progressive Medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658985|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659065|NCT00381641|O1|Outcome|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
658986|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658987|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E): The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658988|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658989|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with Recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658990|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658991|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658992|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658993|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659066|NCT00381641|O2|Outcome|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659514|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
658994|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658995|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658996|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658997|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658998|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
658999|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659000|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659001|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
659002|NCT00381797|E1|Reported Event|PBTC-022|Children with recurrent,progressive,or refractory malignant gliomas, diffuse/intrinsic brain stem gliomas, medulloblastomas and low grade gliomas
659003|NCT00381706|B7|Baseline|Total|Total of all reporting groups
659254|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659004|NCT00381706|B6|Baseline|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659005|NCT00381706|B5|Baseline|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659006|NCT00381706|B4|Baseline|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659007|NCT00381706|B3|Baseline|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659008|NCT00381706|B2|Baseline|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659009|NCT00381706|B1|Baseline|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659010|NCT00381706|P3|Participant Flow|ARM C (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659011|NCT00381706|P2|Participant Flow|Arm B (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659012|NCT00381706|P1|Participant Flow|Arm A (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659013|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659014|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659015|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659067|NCT00381641|O1|Outcome|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659627|NCT00379912|O1|Outcome|Responders|Responders
659016|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659017|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659018|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659019|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659020|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659021|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659022|NCT00381706|O3|Outcome|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659023|NCT00381706|O2|Outcome|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659024|NCT00381706|O1|Outcome|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659025|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659026|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659027|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659068|NCT00381641|O2|Outcome|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
667524|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
659028|NCT00381706|E6|Reported Event|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659029|NCT00381706|E5|Reported Event|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659030|NCT00381706|E4|Reported Event|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659031|NCT00381706|E3|Reported Event|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
659032|NCT00381706|E2|Reported Event|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659033|NCT00381706|E1|Reported Event|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
659034|NCT00381693|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
659035|NCT00381693|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
659036|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
659037|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
659038|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
659039|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
659040|NCT00381693|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
659041|NCT00381680|B3|Baseline|Total|Total of all reporting groups
659042|NCT00381680|B2|Baseline|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
659043|NCT00381680|B1|Baseline|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
659044|NCT00381680|P2|Participant Flow|Regimen B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
659045|NCT00381680|P1|Participant Flow|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
659046|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
659047|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
659048|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2mg)
659049|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
659050|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2mg)
659051|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
659052|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
659053|NCT00381680|O2|Outcome|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
659054|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
659055|NCT00381680|O1|Outcome|All Patients|This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).
659056|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
659057|NCT00381680|E2|Reported Event|Arm B: Randomized High Dose Vincristine Regimen|"See detailed description. Closed to accrual as of 09/2010).~vincristine sulfate: Given IV~prednisone: Given PO~doxorubicin hydrochloride: Given IV~pegaspargase: Given IM~cytarabine: Given IT or IV~methotrexate: Given IT or IV~dexamethasone: Given PO~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV or PO~filgrastim: Given IV or SC~asparaginase: Given IM~mercaptopurine: Given PO"
659058|NCT00381680|E1|Reported Event|Regimen A: Standard Vincristine Dosing|"See detailed description.~vincristine sulfate: Given IV~prednisone: Given PO~doxorubicin hydrochloride: Given IV~pegaspargase: Given IM~cytarabine: Given IT or IV~methotrexate: Given IT or IV~dexamethasone: Given PO~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV or PO~filgrastim: Given IV or SC~asparaginase: Given IM~mercaptopurine: Given PO"
659059|NCT00381641|B3|Baseline|Total|Total of all reporting groups
659173|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659069|NCT00381641|O1|Outcome|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659070|NCT00381641|O2|Outcome|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659071|NCT00381641|O1|Outcome|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659072|NCT00381641|E2|Reported Event|Sunitinib Malate-Metastatic Medullary Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Metastatic Medullary Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659073|NCT00381641|E1|Reported Event|Sunitinib Malate-Radioactive Iodine Refractory Subgroup|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity~This arm contains results for the Radioactive Iodine Refractory Thyroid Cancer Subgroup~Sunitinib Malate: Given PO"
659074|NCT00381628|B5|Baseline|Total|Total of all reporting groups
659075|NCT00381628|B4|Baseline|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659076|NCT00381628|B3|Baseline|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659077|NCT00381628|B2|Baseline|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659078|NCT00381628|B1|Baseline|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659079|NCT00381628|P4|Participant Flow|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659080|NCT00381628|P3|Participant Flow|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659081|NCT00381628|P2|Participant Flow|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659082|NCT00381628|P1|Participant Flow|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659098|NCT00381615|P2|Participant Flow|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
667525|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
659083|NCT00381628|O4|Outcome|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659084|NCT00381628|O3|Outcome|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659085|NCT00381628|O2|Outcome|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659086|NCT00381628|O1|Outcome|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659087|NCT00381628|E4|Reported Event|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659088|NCT00381628|E3|Reported Event|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659089|NCT00381628|E2|Reported Event|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659090|NCT00381628|E1|Reported Event|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
659091|NCT00381615|B5|Baseline|Total|Total of all reporting groups
659092|NCT00381615|B4|Baseline|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
659093|NCT00381615|B3|Baseline|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659094|NCT00381615|B2|Baseline|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659095|NCT00381615|B1|Baseline|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659096|NCT00381615|P4|Participant Flow|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
659097|NCT00381615|P3|Participant Flow|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659099|NCT00381615|P1|Participant Flow|rMenB|"Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months)."
659100|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659101|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659102|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659103|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659104|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
659105|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
659106|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659107|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659108|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659109|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659110|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
659111|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659112|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659113|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659114|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
659115|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659116|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659117|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659118|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
667526|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
659119|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659120|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659121|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659122|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
659123|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659124|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659125|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659126|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
659127|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659128|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659129|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659130|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
659131|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
659132|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659133|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659134|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
659135|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
659136|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659137|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659138|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659169|NCT00381485|P2|Participant Flow|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
667527|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
659139|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659140|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
659141|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
659142|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659143|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659144|NCT00381615|E4|Reported Event|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
659145|NCT00381615|E3|Reported Event|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
659146|NCT00381615|E2|Reported Event|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659147|NCT00381615|E1|Reported Event|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
659148|NCT00381563|B3|Baseline|Total|Total of all reporting groups
659149|NCT00381563|B2|Baseline|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
659150|NCT00381563|B1|Baseline|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
659151|NCT00381563|P2|Participant Flow|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
659152|NCT00381563|P1|Participant Flow|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
659153|NCT00381563|O1|Outcome|Intervention Brace|"All participants who completed the trial (n=67) are re-grouped into the intervention brace group."
659154|NCT00381563|O1|Outcome|Intervention Brace|"All participants who completed the trial (n=67) are re-grouped into the intervention brace group."
659155|NCT00381563|O1|Outcome|Intervention Brace|"All participants who completed the trial (n=67) are re-grouped into the intervention brace group."
659156|NCT00381563|E2|Reported Event|Placebo to Intervention|Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
659157|NCT00381563|E1|Reported Event|Intervention to Placebo|Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.
659158|NCT00381550|B1|Baseline|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
659159|NCT00381550|P1|Participant Flow|Triapine and Fludarabine Phosphate|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
659160|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
659161|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
659162|NCT00381550|E1|Reported Event|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
659163|NCT00381485|B4|Baseline|Total|Total of all reporting groups
659164|NCT00381485|B3|Baseline|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
659165|NCT00381485|B2|Baseline|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659166|NCT00381485|B1|Baseline|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659167|NCT00381485|P4|Participant Flow|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
659168|NCT00381485|P3|Participant Flow|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
667528|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
659175|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659176|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659177|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
659178|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659179|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659180|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
659181|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659182|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659183|NCT00381485|E4|Reported Event|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
659184|NCT00381485|E3|Reported Event|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
659185|NCT00381485|E2|Reported Event|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659186|NCT00381485|E1|Reported Event|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
659187|NCT00381381|B1|Baseline|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
659188|NCT00381381|P1|Participant Flow|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
659189|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
659190|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
659191|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
659192|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
659193|NCT00381381|E1|Reported Event|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
659194|NCT00381303|B3|Baseline|Total|Total of all reporting groups
659195|NCT00381303|B2|Baseline|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659196|NCT00381303|B1|Baseline|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659197|NCT00381303|P2|Participant Flow|Male|darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659198|NCT00381303|P1|Participant Flow|Female|darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659199|NCT00381303|O7|Outcome|Other|
659200|NCT00381303|O6|Outcome|Asian|
659201|NCT00381303|O5|Outcome|Hispanic|
659202|NCT00381303|O4|Outcome|Caucasian|
659203|NCT00381303|O3|Outcome|Black|
659204|NCT00381303|O2|Outcome|Male|
659205|NCT00381303|O1|Outcome|Female|
659206|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659207|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659208|NCT00381303|O7|Outcome|Other|
659209|NCT00381303|O6|Outcome|Asian|
659210|NCT00381303|O5|Outcome|Hispanic|
659211|NCT00381303|O4|Outcome|Caucasian|
659212|NCT00381303|O3|Outcome|Black|
659213|NCT00381303|O2|Outcome|Male|
659214|NCT00381303|O1|Outcome|Female|
659215|NCT00381303|O7|Outcome|Other|
659216|NCT00381303|O6|Outcome|Asian|
659217|NCT00381303|O5|Outcome|Hispanic|
659218|NCT00381303|O4|Outcome|Caucasian|
659219|NCT00381303|O3|Outcome|Black|
659220|NCT00381303|O2|Outcome|Male|
659221|NCT00381303|O1|Outcome|Female|
659222|NCT00381303|O7|Outcome|Other|
659223|NCT00381303|O6|Outcome|Asian|
659224|NCT00381303|O5|Outcome|Hispanic|
659225|NCT00381303|O4|Outcome|Caucasian|
659226|NCT00381303|O3|Outcome|Black|
659227|NCT00381303|O2|Outcome|Male|
659228|NCT00381303|O1|Outcome|Female|
659229|NCT00381303|O7|Outcome|Other|
659230|NCT00381303|O6|Outcome|Asian|
659231|NCT00381303|O5|Outcome|Hispanic|
659232|NCT00381303|O4|Outcome|Caucasian|
659233|NCT00381303|O3|Outcome|Black|
659234|NCT00381303|O2|Outcome|Male|
659235|NCT00381303|O1|Outcome|Female|
659236|NCT00381303|O5|Outcome|Other|
659237|NCT00381303|O4|Outcome|Asian|
659238|NCT00381303|O3|Outcome|Hispanic|
659239|NCT00381303|O2|Outcome|Caucasian|
659240|NCT00381303|O1|Outcome|Black|
659241|NCT00381303|O7|Outcome|Other|
659242|NCT00381303|O6|Outcome|Asian|
659243|NCT00381303|O5|Outcome|Hispanic|
659244|NCT00381303|O4|Outcome|Caucasian|
659245|NCT00381303|O3|Outcome|Black|
659246|NCT00381303|O2|Outcome|Male|
659247|NCT00381303|O1|Outcome|Female|
659248|NCT00381303|O5|Outcome|Other|
659249|NCT00381303|O4|Outcome|Asian|
659250|NCT00381303|O3|Outcome|Hispanic|
659251|NCT00381303|O2|Outcome|Caucasian|
659252|NCT00381303|O1|Outcome|Black|
659253|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659255|NCT00381303|E2|Reported Event|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659256|NCT00381303|E1|Reported Event|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
659257|NCT00381238|B1|Baseline|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659258|NCT00381238|P1|Participant Flow|RSG XR, 8 mg|The study duration was of 50-week (Wk), which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received Rosiglitazone (RSG) extended release (XR), 4 milligram (mg) tablets once daily (od), orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659259|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659260|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659261|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659262|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659263|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659264|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659265|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659266|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659267|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659268|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659269|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659270|NCT00381238|E1|Reported Event|RSG XR, 8 MG|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
659271|NCT00381095|B3|Baseline|Total|Total of all reporting groups
659272|NCT00381095|B2|Baseline|Placebo|Matching placebo capsules orally twice per day
659273|NCT00381095|B1|Baseline|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659274|NCT00381095|P2|Participant Flow|Placebo|Matching placebo capsules orally twice per day
659275|NCT00381095|P1|Participant Flow|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659276|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659277|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659278|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659279|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659280|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659281|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659282|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659283|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659284|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659285|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659286|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659287|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659288|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659289|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659290|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659291|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659292|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659293|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659294|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659295|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659296|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659297|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659298|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659299|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659300|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
659301|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659302|NCT00381095|E2|Reported Event|Placebo|Matching placebo capsules orally twice per day
659303|NCT00381095|E1|Reported Event|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
659304|NCT00381043|B3|Baseline|Total|Total of all reporting groups
659305|NCT00381043|B2|Baseline|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659306|NCT00381043|B1|Baseline|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659307|NCT00381043|P2|Participant Flow|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659308|NCT00381043|P1|Participant Flow|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659309|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659310|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659311|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659312|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659510|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
667529|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
659313|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659314|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659315|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659316|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659317|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659318|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659319|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659320|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659321|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659322|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659323|NCT00381043|E2|Reported Event|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659324|NCT00381043|E1|Reported Event|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
659325|NCT00381004|B1|Baseline|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
659326|NCT00381004|P1|Participant Flow|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
659327|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
659328|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
659329|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
659330|NCT00381004|E1|Reported Event|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
659331|NCT00380978|B3|Baseline|Total|Total of all reporting groups
659332|NCT00380978|B2|Baseline|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659333|NCT00380978|B1|Baseline|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
667530|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
659334|NCT00380978|P2|Participant Flow|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659335|NCT00380978|P1|Participant Flow|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659336|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659337|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659338|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659339|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659340|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659341|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659342|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659343|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659344|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659345|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659346|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659347|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659348|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659349|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659350|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659351|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659352|NCT00380978|E2|Reported Event|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
659353|NCT00380978|E1|Reported Event|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
659354|NCT00380874|B3|Baseline|Total|Total of all reporting groups
659355|NCT00380874|B2|Baseline|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659356|NCT00380874|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659357|NCT00380874|P2|Participant Flow|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659358|NCT00380874|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659359|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659511|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659360|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659361|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659362|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659363|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659364|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659365|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659366|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659367|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659368|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659369|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659370|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659371|NCT00380874|E2|Reported Event|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
659372|NCT00380874|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
659373|NCT00380861|B3|Baseline|Total|Total of all reporting groups
659374|NCT00380861|B2|Baseline|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
659375|NCT00380861|B1|Baseline|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
659376|NCT00380861|P2|Participant Flow|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
659377|NCT00380861|P1|Participant Flow|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
659378|NCT00380861|O2|Outcome|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
659379|NCT00380861|O1|Outcome|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
659380|NCT00380861|E2|Reported Event|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
659381|NCT00380861|E1|Reported Event|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
659382|NCT00380718|B1|Baseline|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659383|NCT00380718|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659384|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659385|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659386|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659387|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659388|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659389|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659390|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659391|NCT00380718|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
659392|NCT00380692|B3|Baseline|Total|Total of all reporting groups
659393|NCT00380692|B2|Baseline|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659394|NCT00380692|B1|Baseline|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659395|NCT00380692|P2|Participant Flow|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659396|NCT00380692|P1|Participant Flow|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659397|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659398|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659399|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659400|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659401|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659402|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659403|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659404|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659405|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659406|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659407|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659408|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659409|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659410|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659411|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659412|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659413|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659414|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659415|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659416|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659417|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659418|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659419|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659420|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659421|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659422|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659423|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659424|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659425|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659512|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659426|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659427|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659428|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659429|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659430|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659431|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659432|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659433|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659434|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659435|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659436|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659437|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659438|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659439|NCT00380692|E2|Reported Event|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
659440|NCT00380692|E1|Reported Event|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
659441|NCT00380588|B3|Baseline|Total|Total of all reporting groups
659442|NCT00380588|B2|Baseline|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
659443|NCT00380588|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
659444|NCT00380588|P2|Participant Flow|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
659445|NCT00380588|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
659446|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
659447|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
659448|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
659449|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
659450|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
659451|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
659452|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
659453|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
667531|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
659454|NCT00380588|E2|Reported Event|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
659455|NCT00380588|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
659456|NCT00380367|B1|Baseline|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
659457|NCT00380367|P1|Participant Flow|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
659458|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
659459|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
659460|NCT00380367|E1|Reported Event|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
659461|NCT00380250|B3|Baseline|Total|Total of all reporting groups
659462|NCT00380250|B2|Baseline|Placebo Study Period I|Subjects who received placebo
659463|NCT00380250|B1|Baseline|Lubiprostone Study Period I|Subjects who received active drug
659464|NCT00380250|P2|Participant Flow|Placebo Study Period I|Subjects who received placebo
659465|NCT00380250|P1|Participant Flow|Lubiprostone Study Period I|Subjects who received active drug
659466|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659467|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659468|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659469|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659470|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659471|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659472|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659473|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659474|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659475|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659476|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659477|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659478|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659479|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659480|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659481|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659482|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659483|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659484|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659485|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659486|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659487|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659488|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659489|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659490|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659491|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659492|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659493|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659494|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659495|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659496|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659497|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659498|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659499|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659500|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659501|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659502|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659503|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659504|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659505|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659506|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659507|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659508|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659509|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659515|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659516|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659517|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659518|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659519|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659520|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659521|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659522|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
659523|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
659524|NCT00380250|E2|Reported Event|Placebo Study Period I|Matching placebo capsules twice daily (BID)
659525|NCT00380250|E1|Reported Event|Lubiprostone Study Period I|8 mcg capsules twice daily (BID)
659526|NCT00380081|B7|Baseline|Total|Total of all reporting groups
659527|NCT00380081|B6|Baseline|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
659528|NCT00380081|B5|Baseline|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
659529|NCT00380081|B4|Baseline|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
659530|NCT00380081|B3|Baseline|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
659531|NCT00380081|B2|Baseline|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
659532|NCT00380081|B1|Baseline|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
659533|NCT00380081|P6|Participant Flow|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
659534|NCT00380081|P5|Participant Flow|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
659535|NCT00380081|P4|Participant Flow|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
659536|NCT00380081|P3|Participant Flow|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
659537|NCT00380081|P2|Participant Flow|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
659538|NCT00380081|P1|Participant Flow|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
659539|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659540|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659541|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659542|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659543|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659544|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659545|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659546|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659547|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659548|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659549|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659550|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659551|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659552|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659553|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659554|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659555|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659746|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659556|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659557|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659558|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659559|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659560|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659561|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659562|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659563|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659564|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659565|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659566|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659567|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659568|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659569|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659570|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659571|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659572|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659573|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659574|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659575|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659576|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659577|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659578|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659579|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659580|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659581|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659582|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659583|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659584|NCT00380081|E3|Reported Event|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659628|NCT00379912|O2|Outcome|Investigational Arm B|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659585|NCT00380081|E2|Reported Event|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659586|NCT00380081|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
659587|NCT00380068|B1|Baseline|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659588|NCT00380068|P1|Participant Flow|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659589|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659590|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659591|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659592|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659593|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659594|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659595|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659596|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659597|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659598|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659599|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659600|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659601|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659602|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
660039|NCT00379639|B5|Baseline|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
659603|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659604|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659605|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659606|NCT00380068|E1|Reported Event|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
659607|NCT00380029|B1|Baseline|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
659608|NCT00380029|P1|Participant Flow|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
659609|NCT00380029|O2|Outcome|Adjuvant Erlotinib|Patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression.
659610|NCT00380029|O1|Outcome|Neoadjuvant Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
659611|NCT00380029|O1|Outcome|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
659612|NCT00380029|O1|Outcome|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
659613|NCT00380029|O1|Outcome|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
659614|NCT00380029|O2|Outcome|Not-downstaged|transurethral resection of a bladder tumor, (TURBT) tumors resected from participants treated with neo-adjuvant erlotinib which were considered to be not-downstaged ( pathologic stage at cystectomy >=pT2 or node positive (N1 or N2))
659615|NCT00380029|O1|Outcome|Downstaged Tumors|transurethral resection of a bladder tumor, (TURBT) tumors resected from participants treated with neo-adjuvant erlotinib which were considered to be downstaged ( pathologic tumor stage at cystectomy <pT2 and N0)
659616|NCT00380029|E1|Reported Event|Erlotinib|"erlotinib given before and after transurethral resection of a bladder tumor, TURBT~Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression~Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib"
659617|NCT00379912|B3|Baseline|Total|Total of all reporting groups
659618|NCT00379912|B2|Baseline|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659619|NCT00379912|B1|Baseline|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659620|NCT00379912|P2|Participant Flow|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659621|NCT00379912|P1|Participant Flow|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659622|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
659623|NCT00379912|O1|Outcome|Responders|Responders
659624|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
659625|NCT00379912|O1|Outcome|Responders|Responders
659626|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
659629|NCT00379912|O1|Outcome|Investigational Arm A|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659630|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659631|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659632|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659633|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659634|NCT00379912|O2|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659635|NCT00379912|O1|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659636|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659637|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659638|NCT00379912|E2|Reported Event|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
659639|NCT00379912|E1|Reported Event|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
659640|NCT00379899|B3|Baseline|Total|Total of all reporting groups
659641|NCT00379899|B2|Baseline|Control|Flexible vitamin D dosing
659642|NCT00379899|B1|Baseline|Cinacalcet|Cinacalcet plus low dose vitamin D
659643|NCT00379899|P2|Participant Flow|Control|Flexible vitamin D dosing
659644|NCT00379899|P1|Participant Flow|Cinacalcet|Cinacalcet plus low dose vitamin D
659645|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659646|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659647|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659648|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659649|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659650|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659651|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659652|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659653|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659654|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659655|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659656|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659657|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659658|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659659|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659660|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659661|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659662|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659663|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659664|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659665|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659666|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659667|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
659668|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
659669|NCT00379899|E2|Reported Event|Control Group|
659670|NCT00379899|E1|Reported Event|Cinacalcet|
659671|NCT00379834|B1|Baseline|Cosopt|Cosopt BID OU
659672|NCT00379834|P1|Participant Flow|Cosopt|Cosopt BID OU
659673|NCT00379834|O1|Outcome|Cosopt|Cosopt twice daily in both eyes
659674|NCT00379834|E1|Reported Event|Cosopt|Cosopt twice daily in both eyes
659675|NCT00379821|B5|Baseline|Total|Total of all reporting groups
659676|NCT00379821|B4|Baseline|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659677|NCT00379821|B3|Baseline|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659678|NCT00379821|B2|Baseline|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659679|NCT00379821|B1|Baseline|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659680|NCT00379821|P4|Participant Flow|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659681|NCT00379821|P3|Participant Flow|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659714|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659682|NCT00379821|P2|Participant Flow|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659683|NCT00379821|P1|Participant Flow|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659684|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659685|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659686|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659687|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659688|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659689|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659690|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659691|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659692|NCT00379821|O1|Outcome|All Groups|Participants Receiving Any Treatment in the Study
659693|NCT00379821|O2|Outcome|Participants Who Did Not Travel and Sleep Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated no.
659694|NCT00379821|O1|Outcome|Participants Who Traveled and Slept Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated yes.
659695|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659696|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659697|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659698|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659699|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659700|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659701|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659702|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659703|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659704|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659705|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659706|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659707|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659708|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659709|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659710|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659711|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659712|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659713|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659715|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659716|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659717|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659718|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659719|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659720|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659721|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659722|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659723|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659724|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659725|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659726|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659727|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659728|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659729|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659730|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659731|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659732|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659733|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659734|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659735|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659736|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659737|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659738|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659739|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659740|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659741|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659742|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659743|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659744|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659745|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
667532|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
659747|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659748|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659749|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659750|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659751|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659752|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659753|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659754|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659755|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659756|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659757|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659758|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659759|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659760|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659761|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659762|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659763|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659764|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659765|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659766|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659767|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659768|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659769|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659770|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659771|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659772|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659773|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659774|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659775|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659776|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659777|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
667533|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
659778|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659779|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659780|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659781|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659782|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659783|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659784|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659785|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659786|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659787|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659788|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659789|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659790|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659791|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659792|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659793|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659794|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659795|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659796|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659797|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659798|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659799|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659800|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659801|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659802|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659803|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659804|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659805|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659806|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659807|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659808|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
660040|NCT00379639|B4|Baseline|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
667534|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
659809|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659810|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659811|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659812|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659813|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659814|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659815|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659816|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659817|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659818|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659819|NCT00379821|E4|Reported Event|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
659820|NCT00379821|E3|Reported Event|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
659821|NCT00379821|E2|Reported Event|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
659822|NCT00379821|E1|Reported Event|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
659823|NCT00379808|B1|Baseline|All Participants|Patients were randomized in a crossover design, but baseline characteristics were presented for all participants. Likewise data are not separated by order of treatment because there were no order effects
659824|NCT00379808|P2|Participant Flow|Montelukast Then Placebo|Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
659825|NCT00379808|P1|Participant Flow|Placebo Then Montelukast|Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover
659826|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
659827|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
659828|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
659829|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
659830|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
659831|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
659832|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
659833|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
659834|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
659835|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
659836|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
659837|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
659838|NCT00379808|E2|Reported Event|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
659839|NCT00379808|E1|Reported Event|Placebo|This is all participants who received placebo, whether in first or second intervention
659840|NCT00379795|B6|Baseline|Total|Total of all reporting groups
659841|NCT00379795|B5|Baseline|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).
659842|NCT00379795|B4|Baseline|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.
659843|NCT00379795|B3|Baseline|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.
659844|NCT00379795|B2|Baseline|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.
659845|NCT00379795|B1|Baseline|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
659846|NCT00379795|P5|Participant Flow|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).
659847|NCT00379795|P4|Participant Flow|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.
659848|NCT00379795|P3|Participant Flow|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.
659849|NCT00379795|P2|Participant Flow|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g
659850|NCT00379795|P1|Participant Flow|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
659851|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
659852|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
659853|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
659854|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
659855|NCT00379795|O4|Outcome|Total|All enrolled subjects
659856|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
660041|NCT00379639|B3|Baseline|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
659857|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.
659858|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
659859|NCT00379795|O4|Outcome|Total|All enrolled subjects
659860|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
659861|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.
659862|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
659863|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
659864|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
659865|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
659866|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
659867|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
659868|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
659869|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
659870|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
667535|NCT00359801|E2|Reported Event|Non-Exubera®|Usual diabetes care
659871|NCT00379795|E4|Reported Event|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
659872|NCT00379795|E3|Reported Event|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study.
659873|NCT00379795|E2|Reported Event|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
659874|NCT00379795|E1|Reported Event|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
659875|NCT00379769|B5|Baseline|Total|Total of all reporting groups
659876|NCT00379769|B4|Baseline|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659877|NCT00379769|B3|Baseline|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659878|NCT00379769|B2|Baseline|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659879|NCT00379769|B1|Baseline|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659880|NCT00379769|P6|Participant Flow|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659881|NCT00379769|P5|Participant Flow|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659882|NCT00379769|P4|Participant Flow|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659883|NCT00379769|P3|Participant Flow|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659884|NCT00379769|P2|Participant Flow|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659885|NCT00379769|P1|Participant Flow|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659886|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659887|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659888|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
660096|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
659889|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659890|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659891|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659892|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659893|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659894|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659895|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659896|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659897|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659898|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659899|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659900|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659901|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659902|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659903|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659904|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659905|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659906|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659907|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659908|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659909|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
660042|NCT00379639|B2|Baseline|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
667619|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
659910|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659911|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659912|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659913|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659914|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659915|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659916|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659917|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659918|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659919|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659920|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659921|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659922|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659923|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659924|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
659925|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
659926|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659927|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659928|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660043|NCT00379639|B1|Baseline|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660097|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
659929|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659930|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659931|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659932|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659933|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659934|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659935|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659936|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659937|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659938|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659939|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659940|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659941|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659942|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660044|NCT00379639|P5|Participant Flow|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
659943|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
659944|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659945|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659946|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659947|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659948|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659949|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659950|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659951|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659952|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659953|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659954|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659955|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659956|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659957|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659958|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659959|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659960|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659961|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659962|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
667701|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
659963|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659964|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659965|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659966|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659967|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659968|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659969|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659970|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659971|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659972|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659973|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659974|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659975|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659976|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659977|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659978|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659979|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659980|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659981|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660001|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660098|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
659982|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659983|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659984|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659985|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659986|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659987|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659988|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659989|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659990|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659991|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659992|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659993|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659994|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659995|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659996|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659997|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659998|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
659999|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660000|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660045|NCT00379639|P4|Participant Flow|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
660002|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660003|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660004|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660005|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660006|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660007|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660008|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660009|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660010|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660011|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660012|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660013|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660014|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660015|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660016|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660017|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660018|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660019|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660036|NCT00379769|E2|Reported Event|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660020|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660021|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660022|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660023|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660024|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660025|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660026|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660027|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660028|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660029|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660030|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660031|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660032|NCT00379769|E6|Reported Event|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
660033|NCT00379769|E5|Reported Event|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
660034|NCT00379769|E4|Reported Event|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660035|NCT00379769|E3|Reported Event|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660037|NCT00379769|E1|Reported Event|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
660046|NCT00379639|P3|Participant Flow|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660047|NCT00379639|P2|Participant Flow|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660048|NCT00379639|P1|Participant Flow|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660049|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660050|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
660051|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660052|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660053|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660054|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660055|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
660056|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660057|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660058|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660059|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660060|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
660061|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660062|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660063|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660064|NCT00379639|E5|Reported Event|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660065|NCT00379639|E4|Reported Event|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
660066|NCT00379639|E3|Reported Event|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
660067|NCT00379639|E2|Reported Event|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660068|NCT00379639|E1|Reported Event|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
660069|NCT00379587|B1|Baseline|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
660070|NCT00379587|P1|Participant Flow|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
660071|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
660072|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
660073|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
660074|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
660075|NCT00379587|E1|Reported Event|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
660076|NCT00379574|B1|Baseline|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
660077|NCT00379574|P1|Participant Flow|Bortezomib + CHOP Every 2 Weeks|"Phase I Bortezomib 1.0, 1/3, and 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5~Phase II Bortezomib 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5"
660078|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
660079|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
660080|NCT00379574|E1|Reported Event|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
660081|NCT00379353|B3|Baseline|Total|Total of all reporting groups
660082|NCT00379353|B2|Baseline|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660083|NCT00379353|B1|Baseline|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660084|NCT00379353|P2|Participant Flow|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660085|NCT00379353|P1|Participant Flow|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660086|NCT00379353|O4|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
660087|NCT00379353|O3|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
660088|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days
660089|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days
660090|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
660091|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
660092|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
660093|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
660094|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
660095|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
660099|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
660100|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
660101|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
660102|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660103|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660104|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660105|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660106|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660107|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660108|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660109|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660110|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660111|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660112|NCT00379353|E2|Reported Event|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
660113|NCT00379353|E1|Reported Event|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
660114|NCT00379340|B6|Baseline|Total|Total of all reporting groups
660115|NCT00379340|B5|Baseline|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
660116|NCT00379340|B4|Baseline|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
660117|NCT00379340|B3|Baseline|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
660118|NCT00379340|B2|Baseline|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
660119|NCT00379340|B1|Baseline|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
660120|NCT00379340|P5|Participant Flow|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
660121|NCT00379340|P4|Participant Flow|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
660122|NCT00379340|P3|Participant Flow|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
660123|NCT00379340|P2|Participant Flow|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
660124|NCT00379340|P1|Participant Flow|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
660125|NCT00379340|O2|Outcome|Lung Mets > 1cm|Lung mets > 1cm
660126|NCT00379340|O1|Outcome|Lung Mets <= 1cm|Lung mets <= 1cm
660127|NCT00379340|O2|Outcome|Stage IV With Non-lung Disease Treated With Regimen M|"Stage IV with non-lung disease treated with Regimen M~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
660128|NCT00379340|O1|Outcome|Stage III/IV With LOH 1p and 16q Treated With Regimen M|"Stage III/IV with LOH 1p and 16q treated with Regimen M~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~3-dimensional conformal radiation therapy~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
660129|NCT00379340|O1|Outcome|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|"Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~3-dimensional conformal radiation therapy~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
660130|NCT00379340|O1|Outcome|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
660131|NCT00379340|E5|Reported Event|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
660132|NCT00379340|E4|Reported Event|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
660133|NCT00379340|E3|Reported Event|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
660134|NCT00379340|E2|Reported Event|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
660135|NCT00379340|E1|Reported Event|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
660136|NCT00379288|B5|Baseline|Total|Total of all reporting groups
660137|NCT00379288|B4|Baseline|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
660138|NCT00379288|B3|Baseline|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
660139|NCT00379288|B2|Baseline|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660140|NCT00379288|B1|Baseline|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660141|NCT00379288|P4|Participant Flow|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
660142|NCT00379288|P3|Participant Flow|F/SC 250/50 mcg BID|fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
660143|NCT00379288|P2|Participant Flow|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660144|NCT00379288|P1|Participant Flow|MF/F 200/10 mcg BID|mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660145|NCT00379288|O4|Outcome|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
660146|NCT00379288|O3|Outcome|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
660147|NCT00379288|O2|Outcome|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660148|NCT00379288|O1|Outcome|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660149|NCT00379288|E4|Reported Event|F/SC MDI 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
660150|NCT00379288|E3|Reported Event|F/SC MDI 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
660151|NCT00379288|E2|Reported Event|MF/F MDI 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660152|NCT00379288|E1|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
660153|NCT00379236|B3|Baseline|Total|Total of all reporting groups
660154|NCT00379236|B2|Baseline|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660155|NCT00379236|B1|Baseline|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660156|NCT00379236|P3|Participant Flow|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660157|NCT00379236|P2|Participant Flow|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660158|NCT00379236|P1|Participant Flow|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660159|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660160|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660161|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660162|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660163|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660164|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660165|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660166|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660167|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660168|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660169|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660170|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660171|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660172|NCT00379236|O1|Outcome|EUFLEXXA™ Double Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660173|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660174|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660175|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660176|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660177|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660178|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660179|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660180|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660181|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660182|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660183|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660184|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660185|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660186|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660187|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660188|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660189|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660190|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660191|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660192|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660193|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660194|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660195|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660196|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660197|NCT00379236|E3|Reported Event|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
660198|NCT00379236|E2|Reported Event|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660199|NCT00379236|E1|Reported Event|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
660200|NCT00379210|B3|Baseline|Total|Total of all reporting groups
660201|NCT00379210|B2|Baseline|Nutrition Education Group|Nutrition education group - received information about nutrition
660391|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
660202|NCT00379210|B1|Baseline|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
660203|NCT00379210|P2|Participant Flow|Nutrition Education Group|Nutrition education group - received information about nutrition
660204|NCT00379210|P1|Participant Flow|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
660205|NCT00379210|O2|Outcome|Nutrition Education Group|Nutrition education group - received information about nutrition
660206|NCT00379210|O1|Outcome|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
660207|NCT00379210|E2|Reported Event|Nutrition Education Group|Nutrition education group - received information about nutrition
660208|NCT00379210|E1|Reported Event|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
660209|NCT00379197|B1|Baseline|Naltrexone|"Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG).~naltrexone hydrochloride: Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.~Positron-emission tomography (PET) / computed tomography (CT): Given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
660210|NCT00379197|P1|Participant Flow|Naltrexone|Naltrexone 50 mg taken orally once daily for 2 28-day cycles with an option to continue on Naltrexone at the discretion of the treating physician.
660211|NCT00379197|O1|Outcome|Naltrexone|"Naltrexone 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.~naltrexone: Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.~PET scan: Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
660212|NCT00379197|O1|Outcome|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.
660213|NCT00379197|E1|Reported Event|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.
660214|NCT00379145|B1|Baseline|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
660215|NCT00379145|P1|Participant Flow|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
660216|NCT00379145|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
660217|NCT00379145|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
660218|NCT00379145|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
660219|NCT00379145|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
660220|NCT00379145|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
660221|NCT00379145|O1|Outcome|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
660222|NCT00379145|E1|Reported Event|Trabectidin|Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
660223|NCT00379080|B4|Baseline|Total|Total of all reporting groups
660224|NCT00379080|B3|Baseline|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660225|NCT00379080|B2|Baseline|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~pharmacological study: Correlative studies"
660226|NCT00379080|B1|Baseline|Arm 1 - Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples"
660227|NCT00379080|P3|Participant Flow|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660228|NCT00379080|P2|Participant Flow|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~pharmacological study: Correlative studies"
660229|NCT00379080|P1|Participant Flow|Arm 1- Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples"
660230|NCT00379080|O10|Outcome|Association Between PFS Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660231|NCT00379080|O9|Outcome|Association Between OS and Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660232|NCT00379080|O8|Outcome|Association Between PFS Biomarker Day 10 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660233|NCT00379080|O7|Outcome|Association Between OS and Biomarker Day 10 /BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660234|NCT00379080|O6|Outcome|Association Between PFS Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660235|NCT00379080|O5|Outcome|Association Between OS and Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660236|NCT00379080|O4|Outcome|Association Between PFS Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660237|NCT00379080|O3|Outcome|Association Between OS and Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660238|NCT00379080|O2|Outcome|Baseline (BL) - Progression Free Survival (PFS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660239|NCT00379080|O1|Outcome|Baseline (BL) - Overall Survival (OS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
660240|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660241|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660242|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660243|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660244|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660245|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660246|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660247|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660248|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660274|NCT00378898|P2|Participant Flow|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
660249|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660250|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660251|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660252|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660253|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660254|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660255|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660256|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660257|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660258|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660275|NCT00378898|P1|Participant Flow|EGD With BRAVO Capsule|"Bravo PH capsule:egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
660276|NCT00378898|O2|Outcome|EGD With Sham BRAVO Capsule Placement|"Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.~sham BRAVO capsule placement"
660392|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
660259|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660260|NCT00379080|O2|Outcome|Level 2 - 600mg BID (Phase 1 & Phase 2)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660261|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660262|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660263|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660264|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660265|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660266|NCT00379080|O1|Outcome|Arm I - Feasibility|"Participants receive oral tandutinib 500 mg twice daily for 7 days prior to surgery. Patients then undergo biopsy or surgery to remove the tumor. Tissue collected for tumor/plasma ratio.~Post surgery, within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (not necessary for feasibility)~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples~conventional surgery: Undergo surgery~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660267|NCT00379080|O1|Outcome|Reporting Group - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. All dose Levels~tandutinib: Given orally~pharmacological study: Correlative studies"
660268|NCT00379080|E3|Reported Event|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660269|NCT00379080|E2|Reported Event|Arm 2 - Dose Escalation (Phase 1)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~the starting dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660270|NCT00379080|E1|Reported Event|Arm I - Feasibility|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples~conventional surgery: Undergo surgery~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
660271|NCT00378898|B3|Baseline|Total|Total of all reporting groups
660272|NCT00378898|B2|Baseline|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
660273|NCT00378898|B1|Baseline|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
660277|NCT00378898|O1|Outcome|EGD With Proximal BRAVO Capsule|"Subjects have a second BRAVO capsule placed 10cm proximal to prior BRAVO capsule placement. Fluoroscopy is used to confirm detachment of the monitor 7 days after investigational deployment.~BRAVO capsule~Fluoroscopy: one time xray to determine evacuation of bravo"
660278|NCT00378898|O2|Outcome|Sham Comparator: EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
660279|NCT00378898|O1|Outcome|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
660280|NCT00378898|E2|Reported Event|EGS With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. Analysis is for participants who completed the study.
660281|NCT00378898|E1|Reported Event|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement. Analysis is for participants who completed the study.~Fluoroscopy: one time xray to determine evacuation of bravo"
660282|NCT00378703|B5|Baseline|Total|Total of all reporting groups
660283|NCT00378703|B4|Baseline|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
660284|NCT00378703|B3|Baseline|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
660285|NCT00378703|B2|Baseline|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
660286|NCT00378703|B1|Baseline|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
660287|NCT00378703|P4|Participant Flow|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
660288|NCT00378703|P3|Participant Flow|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
660289|NCT00378703|P2|Participant Flow|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
660290|NCT00378703|P1|Participant Flow|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
660291|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
660292|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
660293|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
660294|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
660295|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
660296|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
660297|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
660298|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
660299|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
660300|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
660301|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
660302|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
660303|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
660304|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
660305|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
660306|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
660307|NCT00378703|E4|Reported Event|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
660308|NCT00378703|E3|Reported Event|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
660309|NCT00378703|E2|Reported Event|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
668862|NCT00357110|B2|Baseline|Anastrozole|anastrozole 1 mg
660310|NCT00378703|E1|Reported Event|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
660311|NCT00378599|B1|Baseline|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
660312|NCT00378599|P1|Participant Flow|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
660313|NCT00378599|O1|Outcome|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
660314|NCT00378599|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
660315|NCT00378573|B1|Baseline|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
660316|NCT00378573|P1|Participant Flow|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
660317|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
660318|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
660319|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
660320|NCT00378573|E1|Reported Event|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
660321|NCT00378560|B3|Baseline|Total|Total of all reporting groups
660322|NCT00378560|B2|Baseline|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660323|NCT00378560|B1|Baseline|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660324|NCT00378560|P2|Participant Flow|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660325|NCT00378560|P1|Participant Flow|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660326|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660327|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660328|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660329|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660330|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660331|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660332|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660333|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660334|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660335|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660336|NCT00378560|E2|Reported Event|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660337|NCT00378560|E1|Reported Event|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
660338|NCT00378534|B1|Baseline|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
660339|NCT00378534|P1|Participant Flow|CD34 Selection|"T cell depletion~Miltenyi Clinimax CD34 Reagent System: T cell depletion"
660340|NCT00378534|O1|Outcome|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
660341|NCT00378534|E1|Reported Event|Transplant Recipients|"T cell depletion~Miltenyi Clinimax CD34 Reagent System: T cell depletion"
660342|NCT00378508|B3|Baseline|Total|Total of all reporting groups
660343|NCT00378508|B2|Baseline|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660344|NCT00378508|B1|Baseline|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660389|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
660345|NCT00378508|P2|Participant Flow|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660346|NCT00378508|P1|Participant Flow|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660347|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660348|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660349|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660350|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660351|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660352|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660353|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660354|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660355|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660356|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660357|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660358|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660359|NCT00378508|E2|Reported Event|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660360|NCT00378508|E1|Reported Event|Saline Infusions (Placebo)|The course of a saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
660361|NCT00378378|B4|Baseline|Total|Total of all reporting groups
660362|NCT00378378|B3|Baseline|Pooled Placebo|All placebo groups were combined
660363|NCT00378378|B2|Baseline|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
660364|NCT00378378|B1|Baseline|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
660365|NCT00378378|P3|Participant Flow|Pooled Placebo|All placebo groups were combined
660366|NCT00378378|P2|Participant Flow|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
660367|NCT00378378|P1|Participant Flow|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
660368|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
660369|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
660370|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
660371|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
660372|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
660373|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
660374|NCT00378378|E3|Reported Event|Placebo|
660375|NCT00378378|E2|Reported Event|MFNS 100 or 200 mcg BID|
660376|NCT00378378|E1|Reported Event|MFNS 100 or 200 mcg QD|
660377|NCT00378352|B3|Baseline|Total|Total of all reporting groups
660378|NCT00378352|B2|Baseline|Placebo|Dose escalation and efficacy phases
660379|NCT00378352|B1|Baseline|Epoetin Alfa|Dose escalation and efficacy phases
660380|NCT00378352|P6|Participant Flow|Efficacy Phase Placebo|Single dose placebo
660381|NCT00378352|P5|Participant Flow|Efficacy Phase 60,000 Units Epoetin Alfa|Prospective, randomized, double-blind, placebo-controlled trial Single dose 60000 U of epoetin alfa
660382|NCT00378352|P4|Participant Flow|Dose Escalation Placebo|
660383|NCT00378352|P3|Participant Flow|Dose Escalation 60,000 Units Epoetin Alfa|
660384|NCT00378352|P2|Participant Flow|Dose Escalation 30,000 Units Epoetin Alfa|
660385|NCT00378352|P1|Participant Flow|Dose Escalation 15,000 Units Epoetin Alfa|
660386|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
660387|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
660388|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
660390|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
660393|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
660394|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
660395|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
660396|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
660397|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
660398|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
660399|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
660400|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
660401|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
660402|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
660403|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
660404|NCT00378352|E2|Reported Event|Placebo|Patients who received placebo
660405|NCT00378352|E1|Reported Event|Epoetin Alfa|Patients who received active study medication
660406|NCT00378326|B1|Baseline|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
660407|NCT00378326|P1|Participant Flow|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
660408|NCT00378326|O1|Outcome|Tacrolimus|Tacrolimus at doses of 0.15-0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
660409|NCT00378326|O2|Outcome|Post-treatment|White blood cell (WBC) count in CSF post-treatment
660410|NCT00378326|O1|Outcome|Pre-treatment|White blood cell (WBC) count in CSF pre-treatment
660411|NCT00378326|E1|Reported Event|All Patients|All patients enrolled
660412|NCT00378209|B1|Baseline|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
660413|NCT00378209|P1|Participant Flow|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
660414|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|
660415|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
660416|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
660417|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
660449|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660450|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660451|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660418|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
660419|NCT00378209|E1|Reported Event|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
660420|NCT00378105|B3|Baseline|Total|Total of all reporting groups
660421|NCT00378105|B2|Baseline|Phase 2 Population|
660422|NCT00378105|B1|Baseline|Phase 1 Population|
660423|NCT00378105|P2|Participant Flow|Phase 2 Pupulation|Each subject received the maximum planned dose of 1.3 mg/m2/IV bortezomib daily Days 1, 4, 8 and 11 followed by a 10-day rest period, 20 mg PO dexamethasone single daily oral dose Days 1, 2, 4, 5, 8, 9, 11, 12 and25 mg/PO/QD (every day)lenalidomide daily Days 1-14 followed by 7-day rest every 21 days x 4 cycles and then at 10 mg/day on the same schedule for cycles 5 – 8. Each cycle of treatment consisted of 21 days.
660424|NCT00378105|P1|Participant Flow|Phase 1 Population|"Four levels of dose were evaluated and a standard 3+3 dose escalation schema was used to determine the MTD and additional patients were evaluated on the MTD level.~Level 1 1 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 2 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 3 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 20 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 4 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 25 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days"
660425|NCT00378105|O1|Outcome|All Patients|
660426|NCT00378105|O1|Outcome|All Patients|
660427|NCT00378105|O1|Outcome|All Patients|
660428|NCT00378105|O3|Outcome|Total|
660429|NCT00378105|O2|Outcome|Phase II Population|
660430|NCT00378105|O1|Outcome|Phase 1 Population|
660431|NCT00378105|E1|Reported Event|All Patients|
660432|NCT00378079|B4|Baseline|Total|Total of all reporting groups
660433|NCT00378079|B3|Baseline|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660434|NCT00378079|B2|Baseline|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660435|NCT00378079|B1|Baseline|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660436|NCT00378079|P3|Participant Flow|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660437|NCT00378079|P2|Participant Flow|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660438|NCT00378079|P1|Participant Flow|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660439|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660440|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660441|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660442|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660443|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660444|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660445|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660446|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660447|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660448|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660452|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660453|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660454|NCT00378079|E3|Reported Event|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
660455|NCT00378079|E2|Reported Event|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
660456|NCT00378079|E1|Reported Event|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
660457|NCT00378014|B3|Baseline|Total|Total of all reporting groups
660458|NCT00378014|B2|Baseline|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660459|NCT00378014|B1|Baseline|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660460|NCT00378014|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660461|NCT00378014|P1|Participant Flow|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660462|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660463|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660464|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660465|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660466|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660467|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660468|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660469|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660470|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660471|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660472|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660473|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660474|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660475|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660476|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660477|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660478|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660479|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660480|NCT00378014|E4|Reported Event|Extension Period - CNI|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660481|NCT00378014|E3|Reported Event|Extension Period - Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660482|NCT00378014|E2|Reported Event|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
660483|NCT00378014|E1|Reported Event|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
660484|NCT00377962|B3|Baseline|Total|Total of all reporting groups
660485|NCT00377962|B2|Baseline|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660721|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660486|NCT00377962|B1|Baseline|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660487|NCT00377962|P2|Participant Flow|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660488|NCT00377962|P1|Participant Flow|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660489|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660490|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660491|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660492|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660493|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660494|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660495|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660496|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660497|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660498|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660499|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660500|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660501|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660502|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660503|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660577|NCT00377819|B1|Baseline|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
660504|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660505|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660506|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660507|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660508|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660509|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660510|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660511|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
660512|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
660513|NCT00377962|E8|Reported Event|Everolimus + CNI Reduction: 24 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
660514|NCT00377962|E7|Reported Event|Control: 24 Month Lung|"Subgroup of Control group with lung patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
660515|NCT00377962|E6|Reported Event|Everolimus + CNI Reduction: 24 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
660516|NCT00377962|E5|Reported Event|Control: 24 Month Heart|"Subgroup of Control group with heart patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
660517|NCT00377962|E4|Reported Event|Everolimus+CNI Reduction: 12 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
660518|NCT00377962|E3|Reported Event|Control: 12 Month Lung|"Subgroup of control group with lung patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
660519|NCT00377962|E2|Reported Event|Everolimus + CNI Reduction: 12 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
660709|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
660520|NCT00377962|E1|Reported Event|Control: 12 Month Heart|"Subgroup of Control group with heart patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
660521|NCT00377858|B3|Baseline|Total|Total of all reporting groups
660522|NCT00377858|B2|Baseline|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660523|NCT00377858|B1|Baseline|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660524|NCT00377858|P2|Participant Flow|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660525|NCT00377858|P1|Participant Flow|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660526|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660527|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660528|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660529|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660530|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660531|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660532|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660533|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660534|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660535|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660536|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660537|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660538|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660539|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660540|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660541|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660542|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660543|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660544|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660545|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660546|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660547|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660548|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660549|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660550|NCT00377858|E2|Reported Event|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
660551|NCT00377858|E1|Reported Event|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
660552|NCT00377832|B3|Baseline|Total|Total of all reporting groups
660553|NCT00377832|B2|Baseline|Acetaminophen 975 mg Once|
660554|NCT00377832|B1|Baseline|No Medication|
660555|NCT00377832|P2|Participant Flow|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660556|NCT00377832|P1|Participant Flow|In Labor With a Fever Will Give no Medication|
660557|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660558|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
660559|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660560|NCT00377832|O1|Outcome|In Labor With a Fever Will Get no Medication|
660561|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660562|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
660563|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660564|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
660565|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660566|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
660567|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660568|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
660569|NCT00377832|O2|Outcome|Acetaminophen 975 mg Once|
660570|NCT00377832|O1|Outcome|No Medication|
660571|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
660572|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
660573|NCT00377832|E2|Reported Event|Acetaminophen 975 mg Once|In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.
660574|NCT00377832|E1|Reported Event|No Medication|In labor, fever is identified, consent and randomization occurs, then no medication is given.
660575|NCT00377819|B3|Baseline|Total|Total of all reporting groups
660576|NCT00377819|B2|Baseline|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
660578|NCT00377819|P2|Participant Flow|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
660579|NCT00377819|P1|Participant Flow|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
660580|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
660581|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
660582|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
660583|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
660584|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
660585|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
660586|NCT00377819|E2|Reported Event|Denosumab 60 mg Q6M|
660587|NCT00377819|E1|Reported Event|Alendronate 70 mg QW|
660588|NCT00377741|B3|Baseline|Total|Total of all reporting groups
660589|NCT00377741|B2|Baseline|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660590|NCT00377741|B1|Baseline|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660591|NCT00377741|P2|Participant Flow|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660592|NCT00377741|P1|Participant Flow|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660593|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660594|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660595|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660596|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660597|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660598|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660599|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660600|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660601|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660602|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660603|NCT00377741|E2|Reported Event|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
660604|NCT00377741|E1|Reported Event|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
660605|NCT00377676|B3|Baseline|Total|Total of all reporting groups
660606|NCT00377676|B2|Baseline|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660607|NCT00377676|B1|Baseline|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660608|NCT00377676|P2|Participant Flow|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660609|NCT00377676|P1|Participant Flow|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660610|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660611|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660612|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660613|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660614|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660615|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660616|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660617|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660618|NCT00377676|E2|Reported Event|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660619|NCT00377676|E1|Reported Event|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
660620|NCT00377637|B5|Baseline|Total|Total of all reporting groups
660621|NCT00377637|B4|Baseline|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660622|NCT00377637|B3|Baseline|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660623|NCT00377637|B2|Baseline|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660624|NCT00377637|B1|Baseline|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660625|NCT00377637|P4|Participant Flow|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660626|NCT00377637|P3|Participant Flow|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660627|NCT00377637|P2|Participant Flow|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660628|NCT00377637|P1|Participant Flow|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660629|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660630|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660631|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660632|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660633|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660634|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660635|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660636|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660637|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2.0 mg/kg/day along with placebo matching MMF (1.0 g BID), plus corticosteroid for 36 months of therapy
660638|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g twice daily (BID) along with placebo matching AZA (2.0 mg/kg/day), plus corticosteroid, until 36 months of therapy.
660639|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2 mg/kg/day orally once a day + Placebo to MMF orally twice a day + Corticosteroid for 36 months.
660640|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g orally twice a day + Placebo to Azathioprine orally once a day + Corticosteroid for 36 months
660641|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660642|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660643|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660644|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660645|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660646|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660647|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660648|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660649|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660650|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660651|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660652|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660653|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660654|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660655|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660656|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660657|NCT00377637|E4|Reported Event|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
660658|NCT00377637|E3|Reported Event|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
660659|NCT00377637|E2|Reported Event|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
660660|NCT00377637|E1|Reported Event|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
660661|NCT00377572|B3|Baseline|Total|Total of all reporting groups
660662|NCT00377572|B2|Baseline|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660663|NCT00377572|B1|Baseline|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660710|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
660711|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
660712|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
660713|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
660664|NCT00377572|P2|Participant Flow|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660665|NCT00377572|P1|Participant Flow|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660666|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660667|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660668|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660669|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660670|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660671|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660672|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660673|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660674|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660675|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660676|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660714|NCT00377455|E1|Reported Event|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
660715|NCT00377429|B1|Baseline|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660716|NCT00377429|P1|Participant Flow|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660677|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660678|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660679|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660680|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660681|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660682|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660683|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660684|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660685|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660686|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660687|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660688|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660689|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660717|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660718|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660719|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660720|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660690|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660691|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660692|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660693|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660694|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660695|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660696|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660697|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660698|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660699|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660700|NCT00377572|E2|Reported Event|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660701|NCT00377572|E1|Reported Event|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
660702|NCT00377520|B1|Baseline|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
660703|NCT00377520|P1|Participant Flow|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
660704|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
660705|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
660706|NCT00377520|E1|Reported Event|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
660707|NCT00377455|B1|Baseline|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
660708|NCT00377455|P1|Participant Flow|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
660722|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660723|NCT00377429|E1|Reported Event|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
660724|NCT00377403|B3|Baseline|Total|Total of all reporting groups
660725|NCT00377403|B2|Baseline|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
660726|NCT00377403|B1|Baseline|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
660727|NCT00377403|P2|Participant Flow|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
660728|NCT00377403|P1|Participant Flow|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
660729|NCT00377403|O2|Outcome|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
660730|NCT00377403|O1|Outcome|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
660731|NCT00377403|E2|Reported Event|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
660732|NCT00377403|E1|Reported Event|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
660733|NCT00377364|B3|Baseline|Total|Total of all reporting groups
660734|NCT00377364|B2|Baseline|Placebo|Matching Placebo.
660735|NCT00377364|B1|Baseline|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
660736|NCT00377364|P2|Participant Flow|Placebo|Matching Placebo.
660737|NCT00377364|P1|Participant Flow|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
660738|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660739|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660740|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660741|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660742|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660743|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
660744|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660745|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660746|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660747|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
660748|NCT00377364|O2|Outcome|Placebo|Matching placebo.
660749|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660750|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660751|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660752|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660753|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660754|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660755|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660756|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
660757|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
660758|NCT00377364|E2|Reported Event|Placebo|Matching Placebo.
660759|NCT00377364|E1|Reported Event|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
660760|NCT00377312|B3|Baseline|Total|Total of all reporting groups
660761|NCT00377312|B2|Baseline|Parathyroid Hormone(1-34) - 4 Picomoles/kg/hr|Subjects received Parathyroid Hormone (1-34)intravenously at 4 picomoles/kg/hr.
660762|NCT00377312|B1|Baseline|Parathyroid Hormone - 2 Picomoles/kg/hr.|Subjects initially entering the study receive study drug Parathyroid Hormone (1-34) in intravenous doses beginning at 2 picomoles/kg/hr. Doses will be slowly and safely escalated in groups of 3 subjects.
660763|NCT00377312|P2|Participant Flow|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
660764|NCT00377312|P1|Participant Flow|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
660765|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660766|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660767|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660768|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660769|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660770|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660771|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660772|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660773|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660774|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660775|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660776|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660777|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660778|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660779|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660780|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660781|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660782|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660783|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660784|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660785|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660786|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660787|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660788|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
660789|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
660791|NCT00377312|E2|Reported Event|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
660792|NCT00377312|E1|Reported Event|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
660793|NCT00377299|B3|Baseline|Total|Total of all reporting groups
660794|NCT00377299|B2|Baseline|Placebo|
660795|NCT00377299|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
660796|NCT00377299|P2|Participant Flow|Placebo|Placebo identical in appearance to the medication was given beginning at one tablet with an increase to two tablets at week 2, three tablets at week 4 and four tablets at week 6. Patients remained on four tables throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
660797|NCT00377299|P1|Participant Flow|Citicoline|Citicoline add-on therapy was given beginning at one tablet(500mg/day) with an increase to two tablets(1000mg/day) at week 2, three tablets(1500mg/day)at week 4 and four tablets (2000mg/day) at week 6. Patients remained on 2000mg/day throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
660798|NCT00377299|O2|Outcome|Placebo|Placebo.
660799|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
660800|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
660801|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
660802|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
660803|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
660804|NCT00377299|O2|Outcome|Placebo|Placebo.
660805|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
660806|NCT00377299|O2|Outcome|Placebo|Placebo.
660807|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
660808|NCT00377299|E2|Reported Event|Placebo|
660809|NCT00377299|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
660810|NCT00377260|B3|Baseline|Total|Total of all reporting groups
660811|NCT00377260|B2|Baseline|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660812|NCT00377260|B1|Baseline|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660813|NCT00377260|P2|Participant Flow|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660814|NCT00377260|P1|Participant Flow|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660815|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660816|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660817|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660818|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660819|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660820|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660821|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660822|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660823|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660824|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660825|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660826|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660827|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660828|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660829|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660830|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660831|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660832|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660833|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660834|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660835|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660836|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660837|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660838|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660839|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660840|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660841|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660842|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660843|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660986|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660844|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660845|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660846|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660847|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660848|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660849|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660850|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660851|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660852|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660853|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660854|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660855|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660856|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660857|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660858|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660859|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660860|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660861|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660862|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660863|NCT00377260|E2|Reported Event|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
660864|NCT00377260|E1|Reported Event|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
660865|NCT00377234|B3|Baseline|Total|Total of all reporting groups
660866|NCT00377234|B2|Baseline|Sequence B|Risedronate followed by ibandronate
660867|NCT00377234|B1|Baseline|Sequence A|Ibandronate followed by risedronate
660868|NCT00377234|P2|Participant Flow|Sequence B|Risedronate followed by ibandronate
660869|NCT00377234|P1|Participant Flow|Sequence A|Ibandronate followed by risedronate
660870|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
660871|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
660872|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
660873|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
660874|NCT00377234|O2|Outcome|Risedronate|While being treated with risendronate
660875|NCT00377234|O1|Outcome|Ibandronate|While being treated with ibandronate
660876|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
660877|NCT00377234|O2|Outcome|During Sequence B|Risedronate followed by ibandronate
660878|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
660879|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
660880|NCT00377234|O2|Outcome|During Sequence B|Risendronate followed by ibandronate
660881|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
660882|NCT00377234|E2|Reported Event|Risedronate|Risendronate adverse events
660883|NCT00377234|E1|Reported Event|Ibandronate|Ibandronate adverse events
660884|NCT00377156|B3|Baseline|Total|Total of all reporting groups
660885|NCT00377156|B2|Baseline|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
660886|NCT00377156|B1|Baseline|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660887|NCT00377156|P2|Participant Flow|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
660888|NCT00377156|P1|Participant Flow|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660889|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >>~>> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
660890|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660891|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
660987|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
669257|NCT00356148|B3|Baseline|Total|Total of all reporting groups
660892|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660893|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >~> >~> > Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
660894|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660895|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
660896|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660897|NCT00377156|O2|Outcome|Arm II (SRS+WBRT)|"Patients undergo stereotactic radiosurgery (SRS) plus whole-brain radiotherapy (WBRT) received 22 Gy in a single fraction if lesions were less than 2.0cm or 18 Gy if lesions were 2 to 2.9 cm in maximum diameter. >~> Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS."
660898|NCT00377156|O1|Outcome|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660899|NCT00377156|E2|Reported Event|Arm II (SRS+WBRT)|Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS.
660900|NCT00377156|E1|Reported Event|Arm I (SRS)|Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter.
660901|NCT00376961|B1|Baseline|Rituximab-CHOP-Bortezomib (R-CHOP-V)|R-CHOP-V will be administered for 6 cycles (one cycle is defined as a single 21-day course of treatment).
660902|NCT00376961|P2|Participant Flow|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
660903|NCT00376961|P1|Participant Flow|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
660904|NCT00376961|O2|Outcome|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
660905|NCT00376961|O1|Outcome|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
660906|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 dyas). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
660907|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
660908|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
660909|NCT00376961|E2|Reported Event|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
660910|NCT00376961|E1|Reported Event|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle= 21 days)
660911|NCT00376948|B1|Baseline|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
660912|NCT00376948|P1|Participant Flow|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
660913|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
660914|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
660915|NCT00376948|E1|Reported Event|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
660916|NCT00376935|B5|Baseline|Total|Total of all reporting groups
660917|NCT00376935|B4|Baseline|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660988|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660918|NCT00376935|B3|Baseline|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660919|NCT00376935|B2|Baseline|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660920|NCT00376935|B1|Baseline|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660921|NCT00376935|P4|Participant Flow|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660922|NCT00376935|P3|Participant Flow|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660923|NCT00376935|P2|Participant Flow|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660924|NCT00376935|P1|Participant Flow|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660925|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660926|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660927|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660928|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660929|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660930|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660931|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660932|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660933|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660934|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660935|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660936|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660937|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660938|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660939|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660940|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660941|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660942|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660943|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660944|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660945|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660946|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660947|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660948|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660949|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660950|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660951|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660952|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660953|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660954|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660955|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660956|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660957|NCT00376935|E4|Reported Event|Palifermin (60 Mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660958|NCT00376935|E3|Reported Event|Palifermin (40 Mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660959|NCT00376935|E2|Reported Event|Palifermin (20 Mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660960|NCT00376935|E1|Reported Event|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
660961|NCT00376805|B1|Baseline|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
660962|NCT00376805|P1|Participant Flow|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
660963|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
660964|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
660965|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
660966|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
660967|NCT00376805|E1|Reported Event|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
660968|NCT00376688|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
660969|NCT00376688|P1|Participant Flow|Temsirolimus|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
660970|NCT00376688|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
660971|NCT00376688|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
660972|NCT00376675|B3|Baseline|Total|Total of all reporting groups
660973|NCT00376675|B2|Baseline|Placebo|Patients receive oral placebo daily on days 1-28.
660974|NCT00376675|B1|Baseline|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660975|NCT00376675|P2|Participant Flow|Placebo|Patients receive oral placebo daily on days 1-28.
660976|NCT00376675|P1|Participant Flow|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660977|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660978|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660979|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660980|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660981|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660982|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660983|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660984|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660985|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660989|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660990|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660991|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660992|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660993|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
660994|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660995|NCT00376675|E2|Reported Event|Placebo|Patients receive oral placebo daily on days 1-28.
660996|NCT00376675|E1|Reported Event|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
660997|NCT00376597|B3|Baseline|Total|Total of all reporting groups
660998|NCT00376597|B2|Baseline|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
660999|NCT00376597|B1|Baseline|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
661000|NCT00376597|P2|Participant Flow|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
661001|NCT00376597|P1|Participant Flow|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
661002|NCT00376597|O1|Outcome|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
661003|NCT00376597|O2|Outcome|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
661004|NCT00376597|O1|Outcome|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
661005|NCT00376597|O1|Outcome|All Treated Patients|This Arm consists of both Arm I and Arm II.
661006|NCT00376597|O2|Outcome|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
661007|NCT00376597|O1|Outcome|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
661008|NCT00376597|O2|Outcome|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
661009|NCT00376597|O1|Outcome|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
661010|NCT00376597|E2|Reported Event|Arm II (Lymphedema Education, Physical Therapy)|Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
661011|NCT00376597|E1|Reported Event|Arm I (Lymphedema Education)|Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
661012|NCT00376558|B3|Baseline|Total|Total of all reporting groups
661013|NCT00376558|B2|Baseline|Control Subjects|Healthy controls who undergo scans
661014|NCT00376558|B1|Baseline|Cocaine Users|Cocaine users receiving CRA
661015|NCT00376558|P2|Participant Flow|Control Subjects|Healthy controls who undergo scans
661016|NCT00376558|P1|Participant Flow|Cocaine Users|Cocaine users receiving CRA
661017|NCT00376558|O1|Outcome|Cocaine Abuser Undergoing CM With CRA Treatment|Participants receive voucher points for each urine sample that tested negative for benzoylecgonine. Failure to submit a scheduled sample was treated as cocaine +. Voucher points have a monetary value that can be redeemed for goods/services that are approved by the therapist. Points ($0.25) were acquired on an escalating schedule that started at 10 points for the 1st cocaine-free sample, and each subsequent cocaine-free sample increased the value by 5 points. A bonus of 40 points ($10.00) for every 3 consecutive negative sample. Abstinence was confirmed by onsite urine test (Abuscreen On-Trak system, Roche Diagnostics). Missed clinic visits and urine samples that are considered + reset the points to the initial $2.50 value and the escalation schedule resume. Submission of 5 consecutive - samples after a + urine returns the voucher points to the value prior to reset. Points earned are never lost. A maximum of $997.50 is earned for submitting negative samples at all treatment visits.
661018|NCT00376558|O2|Outcome|Control Subjects|Healthy controls who undergo scans
661019|NCT00376558|O1|Outcome|Cocaine Users|Cocaine users receiving CRA
661020|NCT00376558|E2|Reported Event|Control Subjects|Healthy controls who undergo scans
661021|NCT00376558|E1|Reported Event|Cocaine Users|Cocaine users receiving CRA
661022|NCT00376532|B3|Baseline|Total|Total of all reporting groups
661023|NCT00376532|B2|Baseline|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
661024|NCT00376532|B1|Baseline|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
661025|NCT00376532|P2|Participant Flow|No ICD Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
661026|NCT00376532|P1|Participant Flow|ICD Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
661027|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
661028|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
661029|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
661030|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
661031|NCT00376532|E2|Reported Event|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
661032|NCT00376532|E1|Reported Event|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
661033|NCT00376506|B3|Baseline|Total|Total of all reporting groups
661034|NCT00376506|B2|Baseline|Intramuscular|An implanted neurostimulator device used for swallowing retraining
661035|NCT00376506|B1|Baseline|Vibrotactile|An external vibrotactile device used for swallowing retraining
661036|NCT00376506|P2|Participant Flow|Intramuscular|An implanted neurostimulator device used for swallowing retraining
661037|NCT00376506|P1|Participant Flow|Vibrotactile|An external vibrotactile device used for swallowing retraining
661038|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661039|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661040|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661041|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661042|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661043|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661044|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661045|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661046|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.retraining
661047|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661048|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661049|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
661050|NCT00376506|E2|Reported Event|Intramuscular|An implanted neurostimulator device used for swallowing retraining
661051|NCT00376506|E1|Reported Event|Vibrotactile|An external vibrotactile device used for swallowing retraining
661052|NCT00376363|B3|Baseline|Total|Total of all reporting groups
661053|NCT00376363|B2|Baseline|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
661054|NCT00376363|B1|Baseline|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
669958|NCT00354029|B1|Baseline|S (+) Ketamine|
661055|NCT00376363|P2|Participant Flow|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
661056|NCT00376363|P1|Participant Flow|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
661057|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
661058|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
661059|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
661060|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
661061|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
661062|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
661063|NCT00376363|E2|Reported Event|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
661064|NCT00376363|E1|Reported Event|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
661065|NCT00376259|B3|Baseline|Total|Total of all reporting groups
661066|NCT00376259|B2|Baseline|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
661067|NCT00376259|B1|Baseline|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
661068|NCT00376259|P2|Participant Flow|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
661069|NCT00376259|P1|Participant Flow|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
661070|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
661071|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
661072|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
661073|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
661074|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
661075|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
661076|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
661077|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
661078|NCT00376259|E2|Reported Event|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
661079|NCT00376259|E1|Reported Event|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
661080|NCT00376220|B3|Baseline|Total|Total of all reporting groups
661081|NCT00376220|B2|Baseline|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661082|NCT00376220|B1|Baseline|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661083|NCT00376220|P2|Participant Flow|Inactive/ Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661117|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661118|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661119|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661120|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661121|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661084|NCT00376220|P1|Participant Flow|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take twice daily (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID [two capsules in the morning (qAM), two capsules in the evening (qHS)]. If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661085|NCT00376220|O2|Outcome|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661086|NCT00376220|O1|Outcome|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661087|NCT00376220|E2|Reported Event|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661088|NCT00376220|E1|Reported Event|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
661089|NCT00376168|B3|Baseline|Total|Total of all reporting groups
661090|NCT00376168|B2|Baseline|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661091|NCT00376168|B1|Baseline|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661092|NCT00376168|P2|Participant Flow|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661093|NCT00376168|P1|Participant Flow|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661094|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661095|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661096|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661097|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661098|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661099|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661100|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661101|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661102|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661103|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661104|NCT00376168|E2|Reported Event|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
661105|NCT00376168|E1|Reported Event|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
661106|NCT00375999|B1|Baseline|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
661107|NCT00375999|P1|Participant Flow|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
661108|NCT00375999|O1|Outcome|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
661109|NCT00375999|E1|Reported Event|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
661110|NCT00375973|B3|Baseline|Total|Total of all reporting groups
661111|NCT00375973|B2|Baseline|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661112|NCT00375973|B1|Baseline|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661113|NCT00375973|P2|Participant Flow|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661114|NCT00375973|P1|Participant Flow|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661115|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661116|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661122|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661123|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661124|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661125|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661126|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661127|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661128|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661129|NCT00375973|E2|Reported Event|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
661130|NCT00375973|E1|Reported Event|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
661131|NCT00375934|B3|Baseline|Total|Total of all reporting groups
661132|NCT00375934|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
661133|NCT00375934|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661134|NCT00375934|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
661135|NCT00375934|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661136|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661137|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661138|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661139|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661140|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661141|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661142|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661143|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661144|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661145|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661146|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661147|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661148|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661149|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661150|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661151|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661152|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661153|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661154|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661155|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661156|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
661157|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661158|NCT00375934|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
661159|NCT00375934|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
661160|NCT00375752|B3|Baseline|Total|Total of all reporting groups
661161|NCT00375752|B2|Baseline|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661162|NCT00375752|B1|Baseline|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661163|NCT00375752|P2|Participant Flow|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661164|NCT00375752|P1|Participant Flow|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661165|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661166|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661167|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661168|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661169|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661170|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661171|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661172|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661173|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661174|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661175|NCT00375752|E2|Reported Event|Letrozole Plus Zoledronic Acid|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
661176|NCT00375752|E1|Reported Event|Letrozole|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
661177|NCT00375713|B3|Baseline|Total|Total of all reporting groups
661178|NCT00375713|B2|Baseline|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
661179|NCT00375713|B1|Baseline|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
661180|NCT00375713|P2|Participant Flow|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
661181|NCT00375713|P1|Participant Flow|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
661182|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
661183|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
661184|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
661185|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
661186|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
661187|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
661188|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
661189|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
661190|NCT00375713|E2|Reported Event|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
661191|NCT00375713|E1|Reported Event|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
661192|NCT00375674|B3|Baseline|Total|Total of all reporting groups
661193|NCT00375674|B2|Baseline|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661194|NCT00375674|B1|Baseline|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661195|NCT00375674|P2|Participant Flow|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661196|NCT00375674|P1|Participant Flow|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661197|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661198|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661199|NCT00375674|O2|Outcome|Placebo|"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.~Note: n= number of participants with observation of interest"
661200|NCT00375674|O1|Outcome|Sunitinib|"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.~Note: n= number of participants with observation of interest"
661201|NCT00375674|O2|Outcome|Placebo|"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.~Note: n = number of participants with observation of interest"
661202|NCT00375674|O1|Outcome|Sunitinib|"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.~Note: n = number of participants with observation of interest"
661203|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661204|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661205|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661206|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661207|NCT00375674|O2|Outcome|Placebo|"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.~Note: n = number of participants with observation of interest"
661208|NCT00375674|O1|Outcome|Sunitinib|"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.~Note: n = number of participants with observation of interest"
661209|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661210|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661211|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661212|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661213|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661214|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661215|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661216|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661217|NCT00375674|O2|Outcome|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661218|NCT00375674|O1|Outcome|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661219|NCT00375674|E2|Reported Event|Placebo|Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661220|NCT00375674|E1|Reported Event|Sunitinib|Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
661221|NCT00375609|B4|Baseline|Total|Total of all reporting groups
661222|NCT00375609|B3|Baseline|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
661223|NCT00375609|B2|Baseline|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
661224|NCT00375609|B1|Baseline|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
661225|NCT00375609|P3|Participant Flow|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
661226|NCT00375609|P2|Participant Flow|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
661227|NCT00375609|P1|Participant Flow|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
661228|NCT00375609|O3|Outcome|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
661229|NCT00375609|O2|Outcome|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
661230|NCT00375609|O1|Outcome|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
661231|NCT00375609|O3|Outcome|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
661232|NCT00375609|O2|Outcome|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
661233|NCT00375609|O1|Outcome|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
661234|NCT00375609|O3|Outcome|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
661235|NCT00375609|O2|Outcome|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
661236|NCT00375609|O1|Outcome|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
661237|NCT00375609|E3|Reported Event|Enoxaparin|Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days
661238|NCT00375609|E2|Reported Event|Betrixaban 40 mg|Betrixaban 40 mg oral twice daily for 10 to 14 days
661239|NCT00375609|E1|Reported Event|Betrixaban 15 mg|Betrixaban 15 mg oral twice daily for 10 to 14 days
661240|NCT00375518|B3|Baseline|Total|Total of all reporting groups
661241|NCT00375518|B2|Baseline|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661242|NCT00375518|B1|Baseline|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661243|NCT00375518|P2|Participant Flow|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661244|NCT00375518|P1|Participant Flow|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661245|NCT00375518|O2|Outcome|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661246|NCT00375518|O1|Outcome|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661247|NCT00375518|E2|Reported Event|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661248|NCT00375518|E1|Reported Event|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
661249|NCT00375505|B3|Baseline|Total|Total of all reporting groups
661250|NCT00375505|B2|Baseline|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661251|NCT00375505|B1|Baseline|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661252|NCT00375505|P2|Participant Flow|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661253|NCT00375505|P1|Participant Flow|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661254|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661255|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661256|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661257|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661258|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661259|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661260|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661261|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661262|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661263|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661264|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661265|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661266|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661626|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661267|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661268|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661269|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661270|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661271|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661272|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661273|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661274|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661275|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661276|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661277|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661278|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661279|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661280|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661281|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661282|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661283|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661284|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661285|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661286|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661287|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661288|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661289|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661290|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661291|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661292|NCT00375505|E2|Reported Event|Zometa|Zometa
661293|NCT00375505|E1|Reported Event|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
661294|NCT00375492|B3|Baseline|Total|Total of all reporting groups
661295|NCT00375492|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661296|NCT00375492|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661297|NCT00375492|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661298|NCT00375492|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661299|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661300|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661301|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661302|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661303|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661304|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661305|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661306|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661307|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661308|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661309|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661310|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661311|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661312|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661313|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661314|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661315|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661316|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661317|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661318|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661319|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661320|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661321|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661322|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661323|NCT00375492|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
661324|NCT00375492|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
661325|NCT00375427|B3|Baseline|Total|Total of all reporting groups
661326|NCT00375427|B2|Baseline|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661327|NCT00375427|B1|Baseline|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661328|NCT00375427|P2|Participant Flow|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661329|NCT00375427|P1|Participant Flow|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661330|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661331|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661332|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661333|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661334|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661335|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661336|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661337|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661338|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661339|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661340|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661341|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661533|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661342|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661343|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661344|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661345|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661346|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
661347|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661348|NCT00375427|E2|Reported Event|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions
661349|NCT00375427|E1|Reported Event|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
661350|NCT00375219|B4|Baseline|Total|Total of all reporting groups
661351|NCT00375219|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661352|NCT00375219|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661353|NCT00375219|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661354|NCT00375219|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661355|NCT00375219|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661356|NCT00375219|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661357|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661358|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661462|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661359|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661360|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661361|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661362|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661363|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661364|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661365|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661366|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661367|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661368|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661369|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661370|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661371|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661372|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661373|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661374|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661375|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661376|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661377|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661378|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661379|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661380|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661381|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661382|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661383|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661384|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661385|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661386|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661463|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661387|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661388|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661389|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661390|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661391|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661392|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661393|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661394|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661395|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661396|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661397|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661398|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661399|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661400|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661530|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661622|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661401|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661402|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661403|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661404|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661405|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661406|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661407|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661408|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661409|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661410|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661411|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661412|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661413|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661414|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661531|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661623|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661415|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661416|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661417|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661418|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661419|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
661420|NCT00375219|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
661421|NCT00374907|B3|Baseline|Total|Total of all reporting groups
661422|NCT00374907|B2|Baseline|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
661423|NCT00374907|B1|Baseline|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
661424|NCT00374907|P2|Participant Flow|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
661425|NCT00374907|P1|Participant Flow|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
661426|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
661427|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
661428|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
661429|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
661430|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
661431|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
661432|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
661433|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
661434|NCT00374907|E2|Reported Event|SAXAGLIPTIN 5 MG|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
661435|NCT00374907|E1|Reported Event|PLACEBO/METFORMIN|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term)
661436|NCT00374868|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661437|NCT00374868|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661438|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661439|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661532|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661440|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661441|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661442|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661443|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661444|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661445|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661446|NCT00374868|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
661447|NCT00374842|B4|Baseline|Total|Total of all reporting groups
661448|NCT00374842|B3|Baseline|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661449|NCT00374842|B2|Baseline|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661450|NCT00374842|B1|Baseline|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661451|NCT00374842|P3|Participant Flow|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661452|NCT00374842|P2|Participant Flow|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661453|NCT00374842|P1|Participant Flow|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661454|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661455|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661456|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661457|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661458|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661459|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661460|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661461|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661624|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661464|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661465|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661466|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661467|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661468|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661469|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661470|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661471|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661472|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661473|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661474|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661475|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661476|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661477|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661478|NCT00374842|E3|Reported Event|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
661479|NCT00374842|E2|Reported Event|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661480|NCT00374842|E1|Reported Event|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
661481|NCT00374803|B3|Baseline|Total|Total of all reporting groups
661482|NCT00374803|B2|Baseline|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
661483|NCT00374803|B1|Baseline|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
661484|NCT00374803|P2|Participant Flow|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
661485|NCT00374803|P1|Participant Flow|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
661486|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
661487|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
661488|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
661489|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
661490|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
669959|NCT00354029|P2|Participant Flow|Placebo|
661491|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
661492|NCT00374803|O2|Outcome|Mycophenolic Acid (Myfortic) Standard|"Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
661493|NCT00374803|O1|Outcome|Mycophenolic Acid (Myfortic) Preload|"Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
661494|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
661495|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
661496|NCT00374803|E2|Reported Event|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
661497|NCT00374803|E1|Reported Event|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
661498|NCT00374556|B3|Baseline|Total|Total of all reporting groups
661499|NCT00374556|B2|Baseline|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661500|NCT00374556|B1|Baseline|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661501|NCT00374556|P2|Participant Flow|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661502|NCT00374556|P1|Participant Flow|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661503|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661504|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661505|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661506|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661507|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661508|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661509|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661510|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661511|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661512|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661513|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661514|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661515|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661516|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661517|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661518|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661519|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661520|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661521|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661522|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661523|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661524|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661525|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661526|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661527|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661528|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661529|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661534|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661535|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661536|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661537|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661538|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661539|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661540|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661541|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661542|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661543|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661544|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661545|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661546|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661547|NCT00374556|O2|Outcome|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661548|NCT00374556|O1|Outcome|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661549|NCT00374556|E2|Reported Event|Eszoplicone|"Eszoplicone 3mg capsules, once daily at bedtime for 12 weeks~Eszopiclone: 3mg capsule, once daily at bedtime"
661550|NCT00374556|E1|Reported Event|Placebo|"3mg placebo capsule, once daily at bedtime for 12 weeks~Placebo: 3mg placebo capsule, once daily at bedtime"
661551|NCT00374543|B3|Baseline|Total|Total of all reporting groups
661552|NCT00374543|B2|Baseline|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661553|NCT00374543|B1|Baseline|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661554|NCT00374543|P2|Participant Flow|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661555|NCT00374543|P1|Participant Flow|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661556|NCT00374543|O2|Outcome|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661557|NCT00374543|O1|Outcome|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661558|NCT00374543|E2|Reported Event|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661559|NCT00374543|E1|Reported Event|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
661560|NCT00374452|B3|Baseline|Total|Total of all reporting groups
661561|NCT00374452|B2|Baseline|ATHENA-CDS-HTN|"ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.~ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care."
661562|NCT00374452|B1|Baseline|Guideline Link Only|"Link to JNC7 and to VA-DoD hypertension guidelines~Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines."
661563|NCT00374452|P2|Participant Flow|ATHENA-CDS-HTN|"ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.~ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care."
661564|NCT00374452|P1|Participant Flow|Guideline Link Only|"Link to The Seventh Report of the Joint National Committee on Prevention Detection Evaluation and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines~Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA-DoD and JNC7 hypertension guidelines."
661565|NCT00374452|O2|Outcome|ATHENA-CDS-HTN|"ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines.~ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care."
661625|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
669960|NCT00354029|P1|Participant Flow|S (+) Ketamine|
661566|NCT00374452|O1|Outcome|Guideline Link Only|"Link to JNC7 and to VA-DoD hypertension guidelines~Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC hypertension guidelines."
661567|NCT00374452|E2|Reported Event|ATHENA-CDS-HTN Plus Guideline Link|"ATHENA-Clinical Decision Support (CDS)-HTN plus Guideline Link. ATHENA-CDS-HTN display on the cover sheet of electronic health record, plus link to the guidelines~ATHENA-CDS-HTN plus Guideline Link: ATHENA-CDS-HTN display provides guideline-based recommendations to clinicians at the time of patient care."
661568|NCT00374452|E1|Reported Event|Guideline Link Only|"Guideline Link Only. Link to JNC7 and to VA-DoD hypertension guidelines~Guideline Link Only: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC hypertension guidelines."
661569|NCT00374335|B1|Baseline|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
661570|NCT00374335|P1|Participant Flow|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
661571|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
661572|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
661573|NCT00374335|E1|Reported Event|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
661574|NCT00374322|B3|Baseline|Total|Total of all reporting groups
661575|NCT00374322|B2|Baseline|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661576|NCT00374322|B1|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661577|NCT00374322|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661578|NCT00374322|P1|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661579|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661580|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661581|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661582|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661583|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661584|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661585|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661586|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661587|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661588|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661589|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661590|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661591|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661592|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
669961|NCT00354029|O2|Outcome|Placebo|
661593|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal
661594|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661595|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661596|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661597|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661598|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661599|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661600|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661601|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661602|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661603|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661604|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661605|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661606|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661607|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661608|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661609|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661610|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661611|NCT00374322|E2|Reported Event|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661612|NCT00374322|E1|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
661613|NCT00374244|B3|Baseline|Total|Total of all reporting groups
661614|NCT00374244|B2|Baseline|Active Pimozide|Half of the subjects are randomized to the active drug.
661615|NCT00374244|B1|Baseline|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661616|NCT00374244|P2|Participant Flow|Active Pimozide|Half of the subjects are randomized to the active drug.
661617|NCT00374244|P1|Participant Flow|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661618|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661619|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661620|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661621|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661627|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661628|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661629|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661630|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661631|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661632|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661633|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661634|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661635|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661636|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661637|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661638|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661639|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661640|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661641|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661642|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661643|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661644|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661645|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661646|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661647|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661648|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661649|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661650|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661651|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661652|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661653|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661654|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661655|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661656|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661657|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661658|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
661659|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661660|NCT00374244|E2|Reported Event|Active Pimozide|Half of the subjects are randomized to the active drug.
661661|NCT00374244|E1|Reported Event|Placebo Pimozide|Half of the subjects were randomized to placebo group.
661662|NCT00374231|B1|Baseline|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
661663|NCT00374231|P1|Participant Flow|Corticosteroid Withdrawal|Discontinue prednisone at 90 days or longer post liver transplant if rejection free previous 30 days.
661664|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
661665|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
661666|NCT00374231|O1|Outcome|Corticosteroid Withdrawa.|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
661706|NCT00374127|O1|Outcome|Marijuana Blunt 0% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
661707|NCT00374127|E2|Reported Event|Marijuana Cigarette|"marijuana cigarette (0%, 1.8%, or 3.6% THC)~marijuana cigarette"
661667|NCT00374231|E1|Reported Event|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
661668|NCT00374140|B1|Baseline|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
661669|NCT00374140|P1|Participant Flow|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
661670|NCT00374140|O1|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
661671|NCT00374140|O1|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
661672|NCT00374140|O1|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
661673|NCT00374140|O1|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
661674|NCT00374140|E1|Reported Event|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
661675|NCT00374127|B1|Baseline|Marijuana|marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)
661676|NCT00374127|P1|Participant Flow|Marijuana|marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)
661677|NCT00374127|O6|Outcome|Marijuana Cigarette 3.6% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
661678|NCT00374127|O5|Outcome|Marijuana Cigarette 1.8% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
661679|NCT00374127|O4|Outcome|Marijuana Cigarette 0% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
661680|NCT00374127|O3|Outcome|Marijuana Blunt 3.6% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
661681|NCT00374127|O2|Outcome|Marijuana Blunt 1.8% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
661682|NCT00374127|O1|Outcome|Marijuana Blunt 0% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
661683|NCT00374127|O6|Outcome|Marijuana Cigarette 3.6% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
661684|NCT00374127|O5|Outcome|Marijuana Cigarette 1.8% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
661685|NCT00374127|O4|Outcome|Marijuana Cigarette 0% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
661686|NCT00374127|O3|Outcome|Marijuana Blunt 3.6% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
661687|NCT00374127|O2|Outcome|Marijuana Blunt 1.8% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
661688|NCT00374127|O1|Outcome|Marijuana Blunt 0% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
661689|NCT00374127|O6|Outcome|Marijuana Cigarette 3.6% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
661690|NCT00374127|O5|Outcome|Marijuana Cigarette 1.8% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
661691|NCT00374127|O4|Outcome|Marijuana Cigarette 0% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
661692|NCT00374127|O3|Outcome|Marijuana Blunt 3.6% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
661693|NCT00374127|O2|Outcome|Marijuana Blunt 1.8% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
661694|NCT00374127|O1|Outcome|Marijuana Blunt 0% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
661695|NCT00374127|O6|Outcome|Marijuana Cigarette 3.6% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
661696|NCT00374127|O5|Outcome|Marijuana Cigarette 1.8% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
661697|NCT00374127|O4|Outcome|Marijuana Cigarette 0% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
661698|NCT00374127|O3|Outcome|Marijuana Blunt 3.6% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
661699|NCT00374127|O2|Outcome|Marijuana Blunt 1.8% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
661700|NCT00374127|O1|Outcome|Marijuana Blunt 0% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
661701|NCT00374127|O6|Outcome|Marijuana Cigarette 3.6% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
661702|NCT00374127|O5|Outcome|Marijuana Cigarette 1.8% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
661703|NCT00374127|O4|Outcome|Marijuana Cigarette 0% THC|One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
661704|NCT00374127|O3|Outcome|Marijuana Blunt 3.6% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
661705|NCT00374127|O2|Outcome|Marijuana Blunt 1.8% THC|One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
661708|NCT00374127|E1|Reported Event|Marijuana Blunt|"marijuana blunt (0%, 1.8%, or 3.6% THC)~Marijuana blunt"
661709|NCT00374088|B3|Baseline|Total|Total of all reporting groups
661710|NCT00374088|B2|Baseline|N-acetylcysteine|Patients treated with N-acetylcysteine
661711|NCT00374088|B1|Baseline|Placebo|Patients not treated with N-acetylcysteine
661712|NCT00374088|P2|Participant Flow|N-acetylcysteine|Patients treated with N-acetylcysteine
661713|NCT00374088|P1|Participant Flow|Placebo|Patients not treated with N-acetylcysteine
661714|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
661715|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
661716|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
661717|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
661718|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
661719|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
661720|NCT00374088|E2|Reported Event|N-acetylcysteine|Patients treated with N-acetylcysteine
661721|NCT00374088|E1|Reported Event|Placebo|Patients not treated with N-acetylcysteine
661722|NCT00373958|B3|Baseline|Total|Total of all reporting groups
661723|NCT00373958|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661724|NCT00373958|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661725|NCT00373958|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661726|NCT00373958|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661727|NCT00373958|O4|Outcome|7vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661728|NCT00373958|O3|Outcome|13vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661729|NCT00373958|O2|Outcome|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661730|NCT00373958|O1|Outcome|13vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661731|NCT00373958|O4|Outcome|7vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661732|NCT00373958|O3|Outcome|13vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661733|NCT00373958|O2|Outcome|7vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661734|NCT00373958|O1|Outcome|13vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661735|NCT00373958|O8|Outcome|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661736|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661737|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
661952|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661738|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
661739|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
661740|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
661741|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
661742|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
661743|NCT00373958|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661744|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661745|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
661746|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
661747|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
661748|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
661749|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
661750|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
661751|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661752|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661753|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661766|NCT00373958|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661767|NCT00373958|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661754|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661755|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661756|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661757|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661758|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661759|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661760|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661761|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661762|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661763|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661764|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661765|NCT00373958|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661768|NCT00373958|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
661769|NCT00373958|E4|Reported Event|7vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661770|NCT00373958|E3|Reported Event|13vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
661771|NCT00373958|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
661772|NCT00373958|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
661773|NCT00373880|B1|Baseline|Aripiprazole vs. Placebo|Aripiprazole + Cocaine: Participants received aripiprazole (15mg/day) or placebo (o mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
661774|NCT00373880|P1|Participant Flow|Aripiprazole/Placebo, Cocaine|aripiprazole (15 mg/day) or placebo (0mg/day) + smoked cocaine dose–response curve (0, 12, 25, 50 mg)
661775|NCT00373880|O8|Outcome|Aripiprazole + 50mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
661776|NCT00373880|O7|Outcome|Aripiprazole + 25mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.
661777|NCT00373880|O6|Outcome|Aripiprazole + 12mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.
661778|NCT00373880|O5|Outcome|Aripiprazole + 0 mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.
661779|NCT00373880|O4|Outcome|Placebo + 50mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.
661780|NCT00373880|O3|Outcome|Placebo + 25mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.
661781|NCT00373880|O2|Outcome|Placebo + 12mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.
661782|NCT00373880|O1|Outcome|Placebo + 0mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.
661783|NCT00373880|O8|Outcome|Aripiprazole + 50mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
661784|NCT00373880|O7|Outcome|Aripiprazole + 25mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.
661785|NCT00373880|O6|Outcome|Aripiprazole + 12mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.
661786|NCT00373880|O5|Outcome|Aripiprazole + 0 mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.
661787|NCT00373880|O4|Outcome|Placebo + 50mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.
661788|NCT00373880|O3|Outcome|Placebo + 25mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.
661789|NCT00373880|O2|Outcome|Placebo + 12mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.
661790|NCT00373880|O1|Outcome|Placebo + 0mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.
661791|NCT00373880|O8|Outcome|Aripiprazole + 50mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
661792|NCT00373880|O7|Outcome|Aripiprazole + 25mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.
661793|NCT00373880|O6|Outcome|Aripiprazole + 12mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.
661794|NCT00373880|O5|Outcome|Aripiprazole + 0 mg Cocaine|Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.
661795|NCT00373880|O4|Outcome|Placebo + 50mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.
661796|NCT00373880|O3|Outcome|Placebo + 25mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.
661797|NCT00373880|O2|Outcome|Placebo + 12mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.
661798|NCT00373880|O1|Outcome|Placebo + 0mg Cocaine|Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.
661799|NCT00373880|E2|Reported Event|Placebo|Placebo + Cocaine: Participants received placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
661800|NCT00373880|E1|Reported Event|Aripiprazole vs. Placebo|Aripiprazole + Cocaine: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
661801|NCT00373698|B3|Baseline|Total|Total of all reporting groups
661802|NCT00373698|B2|Baseline|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
661803|NCT00373698|B1|Baseline|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
661804|NCT00373698|P2|Participant Flow|Usual Care|"Participants randomized to Usual Care received care at the VA provider's discretion and could include referral to mental health specialty care."
661844|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661845|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661846|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661847|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661848|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661805|NCT00373698|P1|Participant Flow|Three Component Model of Collaborative Care and Usual Care|"Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's Usual Care is at the VA provider's discretion and could include referral to mental health specialty care.specialty care."
661806|NCT00373698|O2|Outcome|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
661807|NCT00373698|O1|Outcome|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
661808|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
661809|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
661810|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
661811|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
661812|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
661813|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
661814|NCT00373698|E2|Reported Event|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
661815|NCT00373698|E1|Reported Event|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
661816|NCT00373685|B3|Baseline|Total|Total of all reporting groups
661817|NCT00373685|B2|Baseline|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661818|NCT00373685|B1|Baseline|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661819|NCT00373685|P2|Participant Flow|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661820|NCT00373685|P1|Participant Flow|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661821|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661822|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661823|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661824|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661825|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661826|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661827|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661828|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661829|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661830|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661831|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661832|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661833|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661834|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661835|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661836|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661837|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661838|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661839|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661840|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661841|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661842|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661843|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
662086|NCT00372970|E1|Reported Event|Botox|Botox injection into pylorus
661849|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661850|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661851|NCT00373685|E2|Reported Event|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
661852|NCT00373685|E1|Reported Event|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
661853|NCT00373529|B1|Baseline|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661854|NCT00373529|P1|Participant Flow|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661855|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661856|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661857|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661858|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661859|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661860|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661861|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661862|NCT00373529|E1|Reported Event|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
661863|NCT00373490|B3|Baseline|Total|Total of all reporting groups
661864|NCT00373490|B2|Baseline|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661865|NCT00373490|B1|Baseline|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661866|NCT00373490|P2|Participant Flow|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661867|NCT00373490|P1|Participant Flow|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661868|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661869|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661870|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661871|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661872|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661873|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661874|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661875|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661876|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661877|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661878|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661879|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661880|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661881|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661882|NCT00373490|E2|Reported Event|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
661883|NCT00373490|E1|Reported Event|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
661884|NCT00373425|B6|Baseline|Total|Total of all reporting groups
662087|NCT00372957|B4|Baseline|Total|Total of all reporting groups
661885|NCT00373425|B5|Baseline|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
661886|NCT00373425|B4|Baseline|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
661887|NCT00373425|B3|Baseline|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
661888|NCT00373425|B2|Baseline|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661889|NCT00373425|B1|Baseline|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661890|NCT00373425|P5|Participant Flow|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
661891|NCT00373425|P4|Participant Flow|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
661892|NCT00373425|P3|Participant Flow|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
661893|NCT00373425|P2|Participant Flow|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661894|NCT00373425|P1|Participant Flow|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661895|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661896|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661897|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661898|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661899|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661900|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661901|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661902|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661903|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661904|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661905|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661906|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661907|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661908|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661909|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661910|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661911|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661951|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661912|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661913|NCT00373425|E5|Reported Event|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
661914|NCT00373425|E4|Reported Event|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
661915|NCT00373425|E3|Reported Event|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
661916|NCT00373425|E2|Reported Event|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661917|NCT00373425|E1|Reported Event|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
661918|NCT00373386|B1|Baseline|Growth Hormone Treatment|
661919|NCT00373386|P1|Participant Flow|Growth Hormone Treatment|Growth hormone 0.3 mg/kg/week given 6 days per week
661920|NCT00373386|O1|Outcome|Growth Hormone Treatment|9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
661921|NCT00373386|O1|Outcome|Growth Hormone Treatment|9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
661922|NCT00373386|O1|Outcome|Growth Hormone Treatment|9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
661923|NCT00373386|O1|Outcome|Growth Hormone Treatment|9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
661924|NCT00373386|O1|Outcome|Growth Hormone|"Growth hormone treatment 0.3 mg/kg/min~growth hormone: Growth Hormone treatment"
661925|NCT00373386|O1|Outcome|Growth Hormone Treatment|"9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests)~1 with panhypopitutarism on cortisol and thyroxine replacement"
661926|NCT00373386|O1|Outcome|Growth Hormone Treatment|"9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests)~1 with panhypopitutarism on cortisol and thyroxine replacement"
661927|NCT00373386|E1|Reported Event|Growth Hormone Treatment|9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies.
661928|NCT00373360|B1|Baseline|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661929|NCT00373360|P1|Participant Flow|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661930|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661931|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661932|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661933|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661934|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661935|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661936|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661937|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661938|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661939|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661940|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661941|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661942|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661943|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661944|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661945|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661946|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661947|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661948|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661949|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661950|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661953|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661954|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661955|NCT00373360|E1|Reported Event|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
661956|NCT00373334|B4|Baseline|Total|Total of all reporting groups
661957|NCT00373334|B3|Baseline|Conservative Measures Only|
661958|NCT00373334|B2|Baseline|Nizatidine 5.0 mg/kg b.i.d.|
661959|NCT00373334|B1|Baseline|Nizatidine 2.5 mg/kg b.i.d.|
661960|NCT00373334|P3|Participant Flow|Placebo|"Placebo plus Conservative Measures~Conservative Measures included:~Hypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure"
661961|NCT00373334|P2|Participant Flow|Nizatidine 5.0 mg/kg Twice Daily|high dose nizatidine plus Conservative Measures
661962|NCT00373334|P1|Participant Flow|Nizatidine 2.5 mg/kg Twice Daily|low dose nizatidine plus Conservative Measures
661963|NCT00373334|O3|Outcome|Conservative Measures Only|
661964|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
661965|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
661966|NCT00373334|O3|Outcome|Conservative Measures Only|
661967|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
661968|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
661969|NCT00373334|O3|Outcome|Conservative Measures Only|
661970|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
661971|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
661972|NCT00373334|E3|Reported Event|Conservative Measures Only|
661973|NCT00373334|E2|Reported Event|Nizatidine 5.0 mg/kg b.i.d.|
661974|NCT00373334|E1|Reported Event|Nizatidine 2.5 mg/kg b.i.d.|
661975|NCT00373295|B1|Baseline|All Study Participants|Participants received placebo, baclofen (60mg) and baclofen (90mg) and smoked Marijuana (5.3% THC).
661976|NCT00373295|P6|Participant Flow|Placebo, Baclofen 60 mg, Baclofen 90 mg|participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days.
661977|NCT00373295|P5|Participant Flow|Placebo, Baclofen 90 mg, Baclofen 60 mg|participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days.
661978|NCT00373295|P4|Participant Flow|Baclofen 90 mg, Baclofen 60 mg, Placebo|participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days.
661979|NCT00373295|P3|Participant Flow|Baclofen 60 mg, Baclofen 90 mg, Placebo|participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days.
661980|NCT00373295|P2|Participant Flow|Baclofen 90 mg, Placebo, Baclofen 60 mg|participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days.
661981|NCT00373295|P1|Participant Flow|Baclofen 60 mg, Placebo, Baclofen 90 mg|participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days.
661982|NCT00373295|O3|Outcome|Baclofen 90, Marijuana|"baclofen (90 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
661983|NCT00373295|O2|Outcome|Placebo, Marijuana|
661984|NCT00373295|O1|Outcome|Baclofen 60, Marijuana|"baclofen (60 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
661985|NCT00373295|E3|Reported Event|Placebo, Marijuana|Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
661986|NCT00373295|E2|Reported Event|Baclofen 90, Marijuana|"baclofen (90 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
661987|NCT00373295|E1|Reported Event|Baclofen 60, Marijuana|"baclofen (60 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
661988|NCT00373269|B3|Baseline|Total|Total of all reporting groups
661989|NCT00373269|B2|Baseline|Hyperglycemic|Subjects with acute ischemic stroke and hyperglycemia.
661990|NCT00373269|B1|Baseline|Normoglycemic|Subjects with acute ischemic stroke and normal blood glucose.
661991|NCT00373269|P2|Participant Flow|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
661992|NCT00373269|P1|Participant Flow|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
661993|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
661994|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
661995|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
661996|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
661997|NCT00373269|E2|Reported Event|Normoglycemic Control|Subjects with acute stroke and normal blood glucose.
661998|NCT00373269|E1|Reported Event|Diabetic Subject|Subjects with acute stroke, hyperglycemia and history of diabetes.
661999|NCT00373256|B3|Baseline|Total|Total of all reporting groups
662000|NCT00373256|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662001|NCT00373256|B1|Baseline|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662002|NCT00373256|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662003|NCT00373256|P1|Participant Flow|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662004|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662005|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662006|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662007|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662008|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662009|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662010|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662011|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662012|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662013|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662014|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662015|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662016|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662017|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662018|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662019|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662020|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662021|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662917|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662022|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662023|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662024|NCT00373256|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662025|NCT00373256|E1|Reported Event|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
662026|NCT00373113|B3|Baseline|Total|Total of all reporting groups
662027|NCT00373113|B2|Baseline|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662028|NCT00373113|B1|Baseline|Sunitinib|37.5 mg daily, continuous dosing
662029|NCT00373113|P2|Participant Flow|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662030|NCT00373113|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) daily, continuous dosing
662031|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662032|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662033|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662034|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662035|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662036|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662037|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662038|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662039|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662040|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662041|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662042|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662043|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662044|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662045|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662046|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
662047|NCT00373113|E2|Reported Event|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
662048|NCT00373113|E1|Reported Event|Sunitinib|37.5 mg daily, continuous dosing
662049|NCT00372996|B3|Baseline|Total|Total of all reporting groups
662050|NCT00372996|B2|Baseline|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
662051|NCT00372996|B1|Baseline|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
662052|NCT00372996|P4|Participant Flow|Exemestane/CP-751,871 + Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
662053|NCT00372996|P3|Participant Flow|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662088|NCT00372957|B3|Baseline|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662089|NCT00372957|B2|Baseline|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662054|NCT00372996|P2|Participant Flow|CP-751,871 + Exemestane/CP-751,871 + Fulvestrant|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
662055|NCT00372996|P1|Participant Flow|CP-751,871 Plus (+) Exemestane|Participants received CP-751,871 20 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle as an intravenous (IV) infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662056|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662057|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662058|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662059|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662060|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662061|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662062|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662063|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662064|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662065|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662066|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662067|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662068|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662069|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662070|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662071|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662072|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662073|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662074|NCT00372996|E4|Reported Event|CP-751,871 + Exemestane (After Exemestane)|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
662075|NCT00372996|E3|Reported Event|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662076|NCT00372996|E2|Reported Event|CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
662077|NCT00372996|E1|Reported Event|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
662078|NCT00372970|B3|Baseline|Total|Total of all reporting groups
662079|NCT00372970|B2|Baseline|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
662080|NCT00372970|B1|Baseline|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
662081|NCT00372970|P2|Participant Flow|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
662082|NCT00372970|P1|Participant Flow|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
662083|NCT00372970|O2|Outcome|Placebo|saline Injection into pylorus
662084|NCT00372970|O1|Outcome|Botox|Botox injection into pylorus
662085|NCT00372970|E2|Reported Event|Placebo|saline Injection into pylorus
662090|NCT00372957|B1|Baseline|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662091|NCT00372957|P3|Participant Flow|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662092|NCT00372957|P2|Participant Flow|GW823093C 15 mg|Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662093|NCT00372957|P1|Participant Flow|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days.
662094|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662095|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662096|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662097|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662098|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662099|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662100|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662101|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662102|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662103|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662104|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662105|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662106|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662107|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662108|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662109|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662110|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662111|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662112|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662113|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662114|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662115|NCT00372957|O3|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662116|NCT00372957|O2|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662117|NCT00372957|O1|Outcome|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662118|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662119|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662120|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662121|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662122|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662123|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662124|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662125|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662126|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662127|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662128|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662129|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662130|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662131|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662132|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662133|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662134|NCT00372957|O2|Outcome|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662135|NCT00372957|O1|Outcome|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662136|NCT00372957|E3|Reported Event|GW823093C 30 mg|Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662137|NCT00372957|E2|Reported Event|GW823093C 15 mg|Participants received one 15 mg of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662138|NCT00372957|E1|Reported Event|Placebo|Participants received two capsules of matching placebo orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
662139|NCT00372775|B1|Baseline|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662140|NCT00372775|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662141|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662142|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662143|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662144|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662145|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662146|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662147|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662148|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662149|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662150|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662151|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662152|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662153|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662154|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662155|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662156|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662157|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662158|NCT00372775|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg oral capsule daily
662159|NCT00372697|B3|Baseline|Total|Total of all reporting groups
662160|NCT00372697|B2|Baseline|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662161|NCT00372697|B1|Baseline|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662266|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662267|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662162|NCT00372697|P2|Participant Flow|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662163|NCT00372697|P1|Participant Flow|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662164|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662165|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662166|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662167|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662168|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662169|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662170|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662171|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662172|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662173|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662174|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662175|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662176|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662177|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662178|NCT00372697|E2|Reported Event|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662179|NCT00372697|E1|Reported Event|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
662180|NCT00372619|B8|Baseline|Total|Total of all reporting groups
662181|NCT00372619|B7|Baseline|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662182|NCT00372619|B6|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662183|NCT00372619|B5|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662184|NCT00372619|B4|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662185|NCT00372619|B3|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662186|NCT00372619|B2|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662187|NCT00372619|B1|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662188|NCT00372619|P7|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662189|NCT00372619|P6|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662190|NCT00372619|P5|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662191|NCT00372619|P4|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662192|NCT00372619|P3|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
663089|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
662193|NCT00372619|P2|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662194|NCT00372619|P1|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662195|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662196|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662197|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662198|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662199|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662200|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662329|NCT00372411|E3|Reported Event|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662201|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662202|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662203|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662204|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662205|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662206|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662207|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662208|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662997|NCT00371267|B2|Baseline|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
662209|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662210|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662211|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662212|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662213|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662214|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662215|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662216|NCT00372619|E7|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
663077|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
662217|NCT00372619|E6|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662218|NCT00372619|E5|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662219|NCT00372619|E4|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662220|NCT00372619|E3|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662221|NCT00372619|E2|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662222|NCT00372619|E1|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
662223|NCT00372593|B4|Baseline|Total|Total of all reporting groups
662224|NCT00372593|B3|Baseline|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662232|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662225|NCT00372593|B2|Baseline|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662226|NCT00372593|B1|Baseline|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662227|NCT00372593|P3|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662228|NCT00372593|P2|Participant Flow|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662229|NCT00372593|P1|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662230|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662231|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662258|NCT00372567|P3|Participant Flow|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
662259|NCT00372567|P2|Participant Flow|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662260|NCT00372567|P1|Participant Flow|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662233|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662234|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662235|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662236|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662237|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662238|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662239|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662261|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662262|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662263|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
669962|NCT00354029|O1|Outcome|S (+) Ketamine|
662240|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662241|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662242|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662243|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662244|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662245|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662246|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662264|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662265|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
663078|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
669963|NCT00354029|E2|Reported Event|Placebo|
662247|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662248|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662249|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662250|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662251|NCT00372593|E3|Reported Event|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662252|NCT00372593|E2|Reported Event|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662253|NCT00372593|E1|Reported Event|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
662254|NCT00372567|B4|Baseline|Total|Total of all reporting groups
662255|NCT00372567|B3|Baseline|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
662256|NCT00372567|B2|Baseline|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662257|NCT00372567|B1|Baseline|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662268|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662269|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662270|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662271|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662272|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662273|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662274|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662275|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662276|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662277|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662278|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662279|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662280|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662281|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662282|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662283|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
662284|NCT00372567|O1|Outcome|Sunitinib|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
662285|NCT00372567|E2|Reported Event|Imatinib|All participants who received Imatinib
662286|NCT00372567|E1|Reported Event|All Participants Who Received Sunitinib|Participants in Phase 1 sub- study and Phase 3 study
662287|NCT00372528|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
662288|NCT00372528|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
662289|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
662290|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
662291|NCT00372528|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
662292|NCT00372489|B1|Baseline|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
662293|NCT00372489|P1|Participant Flow|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
662294|NCT00372489|O1|Outcome|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
662295|NCT00372489|E1|Reported Event|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
662535|NCT00371865|B1|Baseline|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662296|NCT00372424|B1|Baseline|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662297|NCT00372424|P1|Participant Flow|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662298|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662299|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662300|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662301|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662302|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662303|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662304|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662305|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
669964|NCT00354029|E1|Reported Event|S (+) Ketamine|
662306|NCT00372424|E1|Reported Event|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
662307|NCT00372411|B4|Baseline|Total|Total of all reporting groups
662308|NCT00372411|B3|Baseline|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662309|NCT00372411|B2|Baseline|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662310|NCT00372411|B1|Baseline|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
662311|NCT00372411|P3|Participant Flow|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662312|NCT00372411|P2|Participant Flow|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662313|NCT00372411|P1|Participant Flow|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
662314|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662315|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662316|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
662317|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662318|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662319|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
662320|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662321|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662322|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
662323|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662324|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662325|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
662326|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
662327|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662328|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
663079|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
662330|NCT00372411|E2|Reported Event|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
662331|NCT00372411|E1|Reported Event|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
662332|NCT00372385|B5|Baseline|Total|Total of all reporting groups
662333|NCT00372385|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662334|NCT00372385|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662335|NCT00372385|B2|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662336|NCT00372385|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662337|NCT00372385|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662338|NCT00372385|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662339|NCT00372385|P2|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662340|NCT00372385|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662341|NCT00372385|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” and “Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
662342|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662343|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662344|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662345|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662346|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662347|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662348|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662536|NCT00371865|P2|Participant Flow|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662349|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662350|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662351|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662352|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662353|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662354|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662355|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662356|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662357|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662358|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662359|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662360|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662361|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662362|NCT00372385|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
662363|NCT00372385|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
662364|NCT00372385|E2|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
662365|NCT00372385|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
662366|NCT00372190|B3|Baseline|Total|Total of all reporting groups
662367|NCT00372190|B2|Baseline|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
662368|NCT00372190|B1|Baseline|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
662369|NCT00372190|P2|Participant Flow|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse~99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery"
662370|NCT00372190|P1|Participant Flow|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit.~95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion"
662371|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
662372|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
662373|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
662374|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
662375|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
662376|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
662377|NCT00372190|O2|Outcome|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse~99 randomized to conventional surgery, 1 refused surgery for comorbidity, 1 died prior to surgery; 97 underwent conventional surgery"
662378|NCT00372190|O1|Outcome|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit.~95 randomized for mesh, 2 refused surgery; 93 underwent mesh insertion"
662379|NCT00372190|E2|Reported Event|Conventional|"Classical vaginal prolapse surgery (fascia plication)~classic vaginal prolapse surgery (fascia plication): classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse"
662380|NCT00372190|E1|Reported Event|Mesh|"Insertion of Tensionfree vaginal mesh (Prolift)~Tensionfree vaginal mesh kit (Prolift): Insertion of a tension free vaginal mesh using a Prolift mesh kit"
662381|NCT00372112|B5|Baseline|Total|Total of all reporting groups
662382|NCT00372112|B4|Baseline|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662383|NCT00372112|B3|Baseline|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662384|NCT00372112|B2|Baseline|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662385|NCT00372112|B1|Baseline|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662386|NCT00372112|P4|Participant Flow|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662387|NCT00372112|P3|Participant Flow|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662388|NCT00372112|P2|Participant Flow|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662537|NCT00371865|P1|Participant Flow|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662389|NCT00372112|P1|Participant Flow|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662390|NCT00372112|O1|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662391|NCT00372112|O1|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662392|NCT00372112|O1|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662393|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662394|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662395|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662396|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662397|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662398|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662399|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662400|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662401|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
663080|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
662402|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662403|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662404|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662405|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662406|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662407|NCT00372112|O2|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662408|NCT00372112|O1|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662409|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662410|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662411|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662412|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662413|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662414|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
663081|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
662415|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662416|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662417|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662418|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662419|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662420|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662421|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662422|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662423|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662424|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662425|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662426|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662427|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662538|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662428|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662429|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662430|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662431|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662432|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662433|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662434|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662435|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662436|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662437|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662438|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662439|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662440|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662539|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662441|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662442|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662443|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662444|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662445|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662446|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662447|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662448|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662449|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662450|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662451|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662452|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662453|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662540|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662454|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662455|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662456|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662457|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662458|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662459|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662460|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662461|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662462|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662463|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662464|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662465|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662466|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662541|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662467|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662468|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662469|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662470|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662471|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662472|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662473|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662474|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662475|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662476|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662477|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662478|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662479|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662542|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662480|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662481|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662482|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662483|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662484|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662485|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662486|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662487|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662488|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662489|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662490|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662491|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662492|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662543|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662493|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662494|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662495|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662496|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662497|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662498|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662499|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662500|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662501|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662502|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662503|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662504|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662505|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662544|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662506|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662507|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662508|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662509|NCT00372112|O4|Outcome|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662510|NCT00372112|O3|Outcome|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662511|NCT00372112|O2|Outcome|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662512|NCT00372112|O1|Outcome|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662513|NCT00372112|E4|Reported Event|Salmeterol 50 mcg BD|Participants received oral inhalations of salmeterol 50 mcg via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of salmeterol 50 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of salmeterol 50 mcg from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662514|NCT00372112|E3|Reported Event|GW642444 400 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of GW642444 100 mcg (3 inhalations x GW642444 100 mcg) from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662515|NCT00372112|E2|Reported Event|GW642444 100 mcg Once Daily|Participants received oral inhalations of GW642444 100 mcg via DISKUS DPI, once daily for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of GW642444 100 mcg from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662516|NCT00372112|E1|Reported Event|Placebo|Participants received oral inhalations of matching placebo via DISKUS DPI, BD for 2 weeks of treatment period. Participants were provided with 3 inhalers (Inhaler A, B and C) to maintain the blinding. Participants received morning dose of 1 inhalation of placebo from Inhaler A and 3 inhalations of placebo from Inhaler B and evening dose of 1 inhalation of placebo from Inhaler C. Inhaled short acting beta-agonists, ipratropium bromide was provided as rescue medication throughout the study.
662517|NCT00372060|B3|Baseline|Total|Total of all reporting groups
662518|NCT00372060|B2|Baseline|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662519|NCT00372060|B1|Baseline|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662520|NCT00372060|P2|Participant Flow|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662521|NCT00372060|P1|Participant Flow|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662522|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily and who received at least one dose of sitagliptin and were in the CP. This column of data reflects the change from Week 12 at Week 52.
662523|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) orally once daily who were in the CP. This column of data reflects the change from Week 0 at Week 52.
662524|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662525|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662526|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662527|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662528|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662529|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
662530|NCT00372060|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all patients who took sitagliptin in either treatment group. Includes data from Week 0 to Week 52 for patients in the Sitagliptin/Sitagliptin group and data from Week 12 to Week 52 for patients in the Placebo/Sitagliptin group. Includes patients (from either group) who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
662531|NCT00372060|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily. This column of data includes only Weeks 0-12.
662532|NCT00372060|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin orally once daily (Weeks 0-52). This column of data includes only Weeks 0-12.
662533|NCT00371865|B3|Baseline|Total|Total of all reporting groups
662534|NCT00371865|B2|Baseline|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662545|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662546|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662547|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662548|NCT00371865|E2|Reported Event|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
662549|NCT00371865|E1|Reported Event|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
662550|NCT00371839|B4|Baseline|Total|Total of all reporting groups
662551|NCT00371839|B3|Baseline|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662552|NCT00371839|B2|Baseline|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662553|NCT00371839|B1|Baseline|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662554|NCT00371839|P3|Participant Flow|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662555|NCT00371839|P2|Participant Flow|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662556|NCT00371839|P1|Participant Flow|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662557|NCT00371839|O3|Outcome|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662558|NCT00371839|O2|Outcome|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662559|NCT00371839|O1|Outcome|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662560|NCT00371839|E1|Reported Event|Arm 1|"Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
662561|NCT00371826|B4|Baseline|Total|Total of all reporting groups
662562|NCT00371826|B3|Baseline|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662563|NCT00371826|B2|Baseline|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662564|NCT00371826|B1|Baseline|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662565|NCT00371826|P3|Participant Flow|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662566|NCT00371826|P2|Participant Flow|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662754|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662567|NCT00371826|P1|Participant Flow|Calcineurin Inhibitor (CNI) Withdrawal|Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day
662568|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662569|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662570|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662571|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662572|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662573|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662574|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662575|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662755|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
662756|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662576|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662577|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662578|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662579|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662580|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662581|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662582|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662583|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662584|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662757|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662758|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662585|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662586|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662587|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662588|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662589|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662590|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662591|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662592|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662593|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662759|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
662760|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662594|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662595|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662596|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662597|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662598|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662599|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662600|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662601|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662602|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662761|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus placebo tablets BID for 12 days, ± 2 days.
662762|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662603|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662604|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662605|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662606|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662607|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662608|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662609|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662610|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662611|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662763|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
662764|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, ± 2 days.
662612|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662613|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662614|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662615|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662616|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662617|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662618|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662619|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662620|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662780|NCT00371631|E1|Reported Event|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
662621|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662622|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662623|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662624|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662625|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662626|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662627|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662628|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662629|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662781|NCT00371566|B3|Baseline|Total|Total of all reporting groups
662782|NCT00371566|B2|Baseline|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662630|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662631|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662632|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662633|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662634|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662635|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662636|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662637|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662638|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662783|NCT00371566|B1|Baseline|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
670257|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
662639|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662640|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662641|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662642|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662643|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662644|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662645|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662646|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662647|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662784|NCT00371566|P2|Participant Flow|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662648|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662649|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662650|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662651|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662652|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662653|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662654|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662655|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662656|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662785|NCT00371566|P1|Participant Flow|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
670258|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
662657|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662658|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662659|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662660|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662661|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662662|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662663|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662664|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662665|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662786|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662666|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662667|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662668|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662669|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662670|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662671|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662672|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662673|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662674|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662787|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
670259|NCT00352417|E2|Reported Event|Matching Placebo|Placebo Dose
662675|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662676|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662677|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662678|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662679|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662680|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662681|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662682|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662683|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662788|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662684|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662685|NCT00371826|E3|Reported Event|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
662686|NCT00371826|E2|Reported Event|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
662687|NCT00371826|E1|Reported Event|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
662688|NCT00371787|B3|Baseline|Total|Total of all reporting groups
662689|NCT00371787|B2|Baseline|Control Group|normal non-lens wearers
662690|NCT00371787|B1|Baseline|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
662691|NCT00371787|P2|Participant Flow|Control Group|normal non-lens wearers
662692|NCT00371787|P1|Participant Flow|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
662693|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
662694|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
662695|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
662696|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
662697|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
662698|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
662699|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
662700|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
662701|NCT00371787|E2|Reported Event|Control Group|normal non-lens wearers
662702|NCT00371787|E1|Reported Event|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
662703|NCT00371761|B3|Baseline|Total|Total of all reporting groups
662704|NCT00371761|B2|Baseline|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
662705|NCT00371761|B1|Baseline|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
662706|NCT00371761|P2|Participant Flow|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
662707|NCT00371761|P1|Participant Flow|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
662708|NCT00371761|O2|Outcome|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
662709|NCT00371761|O1|Outcome|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
662710|NCT00371761|E2|Reported Event|Adefovir|
662711|NCT00371761|E1|Reported Event|PegIntron|
662712|NCT00371683|B3|Baseline|Total|Total of all reporting groups
662713|NCT00371683|B2|Baseline|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
662714|NCT00371683|B1|Baseline|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
662789|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662715|NCT00371683|P2|Participant Flow|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug(day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
662716|NCT00371683|P1|Participant Flow|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug (day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
662717|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
662718|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662719|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
662720|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
662721|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662722|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662723|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
662724|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
662725|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
662726|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
662727|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
662728|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
662729|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
662730|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
662731|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
662732|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
662733|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662734|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662735|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
662736|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662737|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662738|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662739|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662740|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662741|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662742|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662743|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662744|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662745|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662746|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662747|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662748|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662749|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days,± 2 days.
662750|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662751|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662752|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
662753|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
662765|NCT00371683|E2|Reported Event|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
662766|NCT00371683|E1|Reported Event|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
662767|NCT00371644|B3|Baseline|Total|Total of all reporting groups
662768|NCT00371644|B2|Baseline|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
662769|NCT00371644|B1|Baseline|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
662770|NCT00371644|P2|Participant Flow|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
662771|NCT00371644|P1|Participant Flow|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
662772|NCT00371644|O2|Outcome|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
662773|NCT00371644|O1|Outcome|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
662774|NCT00371644|E2|Reported Event|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
662775|NCT00371644|E1|Reported Event|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
662776|NCT00371631|B1|Baseline|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
662777|NCT00371631|P1|Participant Flow|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
662778|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
662779|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
662790|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662791|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662792|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662793|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662794|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662795|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662796|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662797|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662798|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662799|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662800|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662801|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662802|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662803|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662804|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662805|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662806|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662807|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662808|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662809|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662810|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662811|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662812|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662813|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662814|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662874|NCT00371462|E2|Reported Event|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
662815|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662816|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662817|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662818|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662819|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662820|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662821|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662822|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662823|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662824|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662825|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662826|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662827|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662828|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662829|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662830|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662831|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662832|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662833|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662834|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662835|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662836|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662837|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662838|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662839|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662916|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
670260|NCT00352417|E1|Reported Event|VIA-2291|100-mg dose
662840|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662841|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662842|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662843|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662844|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662845|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662846|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662847|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662848|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662849|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662850|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662851|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662852|NCT00371566|E2|Reported Event|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
662853|NCT00371566|E1|Reported Event|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
662854|NCT00371540|B3|Baseline|Total|Total of all reporting groups
662855|NCT00371540|B2|Baseline|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
662856|NCT00371540|B1|Baseline|I Routine Care|Routine care in the clinic
662857|NCT00371540|P2|Participant Flow|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
662858|NCT00371540|P1|Participant Flow|I Routine Care|Routine care in the clinic
662859|NCT00371540|O2|Outcome|II Home Visits|
662860|NCT00371540|O1|Outcome|I Rountine Care|
662861|NCT00371540|O2|Outcome|II Home Visits|
662862|NCT00371540|O1|Outcome|I Rountine Care|
662863|NCT00371540|O2|Outcome|II Home Visits|
662864|NCT00371540|O1|Outcome|I Rountine Care|
662865|NCT00371540|E2|Reported Event|II Home Visits|
662866|NCT00371540|E1|Reported Event|I Rountine Care|
662867|NCT00371462|B3|Baseline|Total|Total of all reporting groups
662868|NCT00371462|B2|Baseline|Arm 2|"MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)~MOVE! level 2 group weight loss counseling: Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months."
662869|NCT00371462|B1|Baseline|Arm 1|"MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);~Use of PDA + support to reduce weight and pain: participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months."
662870|NCT00371462|P2|Participant Flow|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
662871|NCT00371462|P1|Participant Flow|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
662872|NCT00371462|O2|Outcome|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
662873|NCT00371462|O1|Outcome|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
662875|NCT00371462|E1|Reported Event|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
662876|NCT00371449|B1|Baseline|Hearing Aid Users|Hearing aid users
662877|NCT00371449|P1|Participant Flow|Hearing-Aid Users|Individuals who wore hearing aids for > 3 months and at their current setting for at least 1 month
662878|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
662879|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
662880|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
662881|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
662882|NCT00371449|O1|Outcome|Hearing-aid Users|hearing aid users
662883|NCT00371449|O1|Outcome|Group 1|hearing aid users
662884|NCT00371449|E1|Reported Event|Hearing-aid Users|
662885|NCT00371436|B3|Baseline|Total|Total of all reporting groups
662886|NCT00371436|B2|Baseline|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
662887|NCT00371436|B1|Baseline|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
662888|NCT00371436|P2|Participant Flow|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
662889|NCT00371436|P1|Participant Flow|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
662890|NCT00371436|O2|Outcome|Arm 2|"Usual Care~Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic."
662891|NCT00371436|O1|Outcome|Arm 1|"Tinnitus Progressive Management~Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
662892|NCT00371436|E2|Reported Event|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
662893|NCT00371436|E1|Reported Event|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
662894|NCT00371397|B1|Baseline|Overall Study|Women were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. The order of the visits was randomized per participant. 52 total participants enrolled.
662895|NCT00371397|P12|Participant Flow|Novice: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
662896|NCT00371397|P11|Participant Flow|Novice: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity."
662897|NCT00371397|P10|Participant Flow|Novice: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
662898|NCT00371397|P9|Participant Flow|Novice: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
662899|NCT00371397|P8|Participant Flow|Novice: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
662900|NCT00371397|P7|Participant Flow|Novice: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
662901|NCT00371397|P6|Participant Flow|Expert: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
662902|NCT00371397|P5|Participant Flow|Expert: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
662903|NCT00371397|P4|Participant Flow|Expert: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
662904|NCT00371397|P3|Participant Flow|Expert: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning."
662905|NCT00371397|P2|Participant Flow|Expert: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
662906|NCT00371397|P1|Participant Flow|Expert: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
662907|NCT00371397|O2|Outcome|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
662908|NCT00371397|O1|Outcome|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
662909|NCT00371397|E2|Reported Event|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
662910|NCT00371397|E1|Reported Event|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
662911|NCT00371345|B3|Baseline|Total|Total of all reporting groups
662912|NCT00371345|B2|Baseline|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662913|NCT00371345|B1|Baseline|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662914|NCT00371345|P2|Participant Flow|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662915|NCT00371345|P1|Participant Flow|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
663082|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
662918|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662919|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662920|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662921|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662922|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662923|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662924|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662925|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662926|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662927|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662928|NCT00371345|O3|Outcome|Dasatinib 50 mg|Dasatinib was administered orally at a starting dose of 70 mg BID. Dose adjustment was made according to tolerance, with reduction to 50 mg BID. Participants continued study treatment until PD or unacceptable toxicity. Dasatinib dose was adjusted so that drug-related toxicities were either Grade 0 - 1 or were Grade 2 toxicities that were adequately managed with outpatient therapy or deemed clinically acceptable.
662929|NCT00371345|O2|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662930|NCT00371345|O1|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662931|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662932|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662933|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662934|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662935|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662936|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662937|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662938|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662939|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
662940|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
662941|NCT00371345|O3|Outcome|Participant CA180088-29-88085, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 70 mg dasatinib BID
662942|NCT00371345|O2|Outcome|Participant CA180088-16-88002, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 100 mg dasatinib BID
662943|NCT00371345|O1|Outcome|Participant CA180088-18-88009, HER-2 Group|Participant with Human epidermal growth factor (Her2/neu)–amplified tumor type (also positive for ER and PgR) who received 100 mg dasatinib BID.
662944|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662945|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662946|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662947|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662948|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
662949|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
662950|NCT00371345|O3|Outcome|All Participants|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
663083|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
662951|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
662952|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
662953|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662954|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662955|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662956|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662957|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662958|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662959|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662960|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662961|NCT00371345|O5|Outcome|All Response-evaluable Participants|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).
662962|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662963|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662964|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662965|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662966|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662967|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662968|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
662969|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
662970|NCT00371345|E1|Reported Event|Dasatinib|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
662971|NCT00371293|B4|Baseline|Total|Total of all reporting groups
663084|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
662972|NCT00371293|B3|Baseline|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662973|NCT00371293|B2|Baseline|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662974|NCT00371293|B1|Baseline|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662975|NCT00371293|P3|Participant Flow|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662976|NCT00371293|P2|Participant Flow|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662977|NCT00371293|P1|Participant Flow|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662978|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662979|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662980|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662981|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662982|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662983|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662984|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662985|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662986|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662987|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662988|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will receive take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662989|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662990|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662991|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662992|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662993|NCT00371293|E3|Reported Event|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
662994|NCT00371293|E2|Reported Event|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662995|NCT00371293|E1|Reported Event|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
662996|NCT00371267|B3|Baseline|Total|Total of all reporting groups
663085|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
662998|NCT00371267|B1|Baseline|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
662999|NCT00371267|P2|Participant Flow|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
663000|NCT00371267|P1|Participant Flow|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
663001|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
663002|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
663003|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
663004|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
663005|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
663006|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
663007|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
663008|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
663009|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
663010|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
663011|NCT00371267|E2|Reported Event|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
663012|NCT00371267|E1|Reported Event|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
663013|NCT00371254|B3|Baseline|Total|Total of all reporting groups
663014|NCT00371254|B2|Baseline|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663015|NCT00371254|B1|Baseline|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663016|NCT00371254|P2|Participant Flow|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663017|NCT00371254|P1|Participant Flow|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663018|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663019|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663020|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663021|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663086|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663087|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663088|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663022|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663023|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663024|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663025|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663026|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663027|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663028|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663029|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663030|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663031|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663032|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663033|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663034|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663035|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663036|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663037|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663038|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663039|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663040|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663041|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663042|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663043|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663044|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663045|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663046|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663047|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663048|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663049|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663050|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663051|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663052|NCT00371254|O3|Outcome|Dasatinib 50 mg BID|Participants were administered an oral dose of 50 mg dasatinib tablet twice daily for a total daily dose (TDD) of 100 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663053|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663054|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663055|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663056|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663057|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663058|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663059|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663060|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663061|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663062|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663063|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663064|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663065|NCT00371254|E1|Reported Event|All Participants|All treated participants who were administered a twice-daily oral dose of either 100 mg (TDD 200 mg) or 70 mg (TDD 140 mg) dasatinib tablet. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
663066|NCT00371176|B3|Baseline|Total|Total of all reporting groups
663067|NCT00371176|B2|Baseline|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663068|NCT00371176|B1|Baseline|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663069|NCT00371176|P2|Participant Flow|Placebo Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a placebo pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
663070|NCT00371176|P1|Participant Flow|D-Cycloserine Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a 50 mg DCS pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
663071|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663072|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663073|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663074|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663075|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663076|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663090|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663091|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663092|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663093|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663094|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663095|NCT00371176|E2|Reported Event|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
663096|NCT00371176|E1|Reported Event|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
663097|NCT00371150|B3|Baseline|Total|Total of all reporting groups
663098|NCT00371150|B2|Baseline|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663099|NCT00371150|B1|Baseline|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663100|NCT00371150|P2|Participant Flow|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663101|NCT00371150|P1|Participant Flow|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663102|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663103|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663104|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663105|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663106|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663107|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663108|NCT00371150|O3|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663109|NCT00371150|O2|Outcome|Hispanic|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663110|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663111|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663112|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663113|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663114|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663115|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663116|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663117|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663118|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663119|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663120|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663121|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663122|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663123|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663124|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663125|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663126|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663127|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663128|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663129|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
663130|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
663131|NCT00371150|E1|Reported Event|Entecavir (ETV)|Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)
663132|NCT00371137|B4|Baseline|Total|Total of all reporting groups
663133|NCT00371137|B3|Baseline|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
663134|NCT00371137|B2|Baseline|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
663135|NCT00371137|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
663136|NCT00371137|P3|Participant Flow|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
663137|NCT00371137|P2|Participant Flow|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
663138|NCT00371137|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
663139|NCT00371137|O3|Outcome|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
663140|NCT00371137|O2|Outcome|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
663141|NCT00371137|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
663142|NCT00371137|E3|Reported Event|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
663143|NCT00371137|E2|Reported Event|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
663144|NCT00371137|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
663145|NCT00370994|B3|Baseline|Total|Total of all reporting groups
663146|NCT00370994|B2|Baseline|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
663147|NCT00370994|B1|Baseline|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
663148|NCT00370994|P2|Participant Flow|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
663149|NCT00370994|P1|Participant Flow|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.
663150|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
663151|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
663152|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
663153|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
663154|NCT00370994|E2|Reported Event|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
663155|NCT00370994|E1|Reported Event|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
663156|NCT00370838|B3|Baseline|Total|Total of all reporting groups
663157|NCT00370838|B2|Baseline|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
663158|NCT00370838|B1|Baseline|Levetiracetam First, Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
663159|NCT00370838|P2|Participant Flow|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
663160|NCT00370838|P1|Participant Flow|First Levetiracetam Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
663161|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663162|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663365|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663366|NCT00369967|O2|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663163|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663164|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663165|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663166|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663167|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663168|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663169|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663170|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663171|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663172|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663173|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663174|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663175|NCT00370838|E2|Reported Event|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663176|NCT00370838|E1|Reported Event|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
663177|NCT00370682|B4|Baseline|Total|Total of all reporting groups
671523|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
663178|NCT00370682|B3|Baseline|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663179|NCT00370682|B2|Baseline|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663180|NCT00370682|B1|Baseline|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663181|NCT00370682|P3|Participant Flow|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663182|NCT00370682|P2|Participant Flow|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663183|NCT00370682|P1|Participant Flow|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663184|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663185|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663186|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663187|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663188|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663189|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663190|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663191|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663192|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663193|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663194|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663195|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663196|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663197|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663198|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663199|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663200|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663201|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663202|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
671524|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
663203|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663204|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663205|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663206|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663207|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663208|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663209|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663210|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663211|NCT00370682|O4|Outcome|PII (M9)|Post dose 2, Month 9
663212|NCT00370682|O3|Outcome|PII (M7)|Post dose 2, Month 7
663213|NCT00370682|O2|Outcome|PI (M1)|Post dose1 , Month 1
663214|NCT00370682|O1|Outcome|PRE Dose|Pre-dose 1
663215|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663216|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663217|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663218|NCT00370682|E3|Reported Event|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663219|NCT00370682|E2|Reported Event|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663220|NCT00370682|E1|Reported Event|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
663221|NCT00370552|B4|Baseline|Total|Total of all reporting groups
663222|NCT00370552|B3|Baseline|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663223|NCT00370552|B2|Baseline|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663224|NCT00370552|B1|Baseline|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663225|NCT00370552|P3|Participant Flow|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663226|NCT00370552|P2|Participant Flow|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663535|NCT00369928|E3|Reported Event|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
663227|NCT00370552|P1|Participant Flow|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663228|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663229|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663230|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663231|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663232|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663233|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663234|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663235|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663236|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663237|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663238|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663308|NCT00370149|P1|Participant Flow|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to M/R had the catheter impregnated with minocycline and rifampin (M/R) inserted intraoperatively. The specific Central Venous Catheters are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
663239|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663240|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663241|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663242|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663243|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663244|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663245|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663246|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663247|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663248|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663249|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663250|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663309|NCT00370149|O2|Outcome|Conventional Non-impegnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J) 5 Fr.,12 cm long, (C-UDLM-501J-RSC).
671525|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
663251|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663252|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663253|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663254|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663255|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663256|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663257|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663258|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663259|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663260|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663261|NCT00370552|E3|Reported Event|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663262|NCT00370552|E2|Reported Event|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity. After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone, as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663310|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
663263|NCT00370552|E1|Reported Event|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone, as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
663264|NCT00370331|B3|Baseline|Total|Total of all reporting groups
663265|NCT00370331|B2|Baseline|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663266|NCT00370331|B1|Baseline|Placebo|Matching placebo tablets taken once a day
663267|NCT00370331|P2|Participant Flow|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663268|NCT00370331|P1|Participant Flow|Placebo|Matching placebo tablets taken once a day
663269|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663270|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663271|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663272|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663273|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663274|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663275|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663276|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663277|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663278|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663279|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663280|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663281|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663282|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663283|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663284|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663285|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663286|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663287|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663288|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
663289|NCT00370331|E2|Reported Event|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
663290|NCT00370331|E1|Reported Event|Placebo|Matching placebo tablets taken once a day
663291|NCT00370292|B3|Baseline|Total|Total of all reporting groups
663292|NCT00370292|B2|Baseline|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
663293|NCT00370292|B1|Baseline|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
663294|NCT00370292|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
663295|NCT00370292|O3|Outcome|hENT - Cycle 3|Mean hENT expression evaluated at Cycle 3.
663296|NCT00370292|O2|Outcome|hENT - Cycle 2|Mean hENT expression evaluated at Cycle 2.
663297|NCT00370292|O1|Outcome|hENT - Cycle 1|Mean hENT expression evaluated at Cycle 1.
663298|NCT00370292|O2|Outcome|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
663299|NCT00370292|O1|Outcome|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
663300|NCT00370292|O3|Outcome|dCK - Cycle 3|Mean dCK expression evaluated at Cycle 3.
663301|NCT00370292|O2|Outcome|dCK - Cycle 2|Mean dCK expression evaluated at Cycle 2.
663302|NCT00370292|O1|Outcome|dCK - Cycle 1|Mean dCK expression evaluated at Cycle 1.
663303|NCT00370292|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
663304|NCT00370149|B3|Baseline|Total|Total of all reporting groups
663305|NCT00370149|B2|Baseline|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J RSC).
663306|NCT00370149|B1|Baseline|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were sized to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM) and C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC).
663307|NCT00370149|P2|Participant Flow|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to this arm had the conventional Central Venous Catheter (C/S) with no antibiotic coating inserted intraoperatively. The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
663536|NCT00369928|E2|Reported Event|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
663311|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
663312|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
663313|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
663314|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
663315|NCT00370149|E2|Reported Event|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if there was a therapeutic difference between the M/R and C/S catheters. Patients randomized to this arm had the C/S inserted intra-operatively. Patients receiving this catheter were enrolled in the study.The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC). Patients were followed for adverse device affects and adverse events through their hospitalization stay
663316|NCT00370149|E1|Reported Event|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if a therapeutic difference existed between M/R and C/S catheters. Patients randomized to this Arm had the M/R catheter inserted intra-operatively. Patients receiving this Catheter were enrolled in the study. The specific CVCs are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). Patients were followed for adverse device affects and adverse events through their hospitalization stay.
663317|NCT00370071|B1|Baseline|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 micrograms (8 MIU [million international units]) subcutaneously every other day.
663318|NCT00370071|P1|Participant Flow|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663319|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663320|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663321|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663322|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663323|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663324|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663325|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663326|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663327|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663328|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663329|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663330|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663331|NCT00370071|E1|Reported Event|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
663332|NCT00370032|B3|Baseline|Total|Total of all reporting groups
663333|NCT00370032|B2|Baseline|Healthy Volunteers|Volunteers without clinical disease. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
663334|NCT00370032|B1|Baseline|d-IBS|Diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
663335|NCT00370032|P2|Participant Flow|Healthy Volunteers|Subjects with no clinical disease. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by flexible sigmoidoscopy then had a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
663363|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663364|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663336|NCT00370032|P1|Participant Flow|d-IBS (Diarrhea Predominant - Irritable Bowel Syndrome)|Subjects with diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by a flexible sigmoidoscopy then had a 7 day follow up period.
663337|NCT00370032|O4|Outcome|Healthy Volunteers Placebo - Rectal|Subjects without clinical disease. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
663338|NCT00370032|O3|Outcome|Healthy Volunteers Placebo - Left Colon|Subjects without Clinical disease. Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
663339|NCT00370032|O2|Outcome|d-IBS Placebo - Rectal|Subjects with diarrhea-predominant irritable bowel syndrome. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
663340|NCT00370032|O1|Outcome|d-IBS Placebo - Left Colon|Subjects with diarrhea-predominant irritable bowel syndrome . Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
663341|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
663342|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
663343|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
663344|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
663345|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
663346|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
663347|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1, this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
663348|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
663349|NCT00370032|E4|Reported Event|Healthy Volunteers Alosetron|Volunteers without clinical disease. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
663350|NCT00370032|E3|Reported Event|Healthy Volunteers Placebo|Volunteers without clinical disease. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
663351|NCT00370032|E2|Reported Event|d-IBS Alosetron|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
663352|NCT00370032|E1|Reported Event|d-IBS Placebo|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
663353|NCT00369967|B3|Baseline|Total|Total of all reporting groups
663354|NCT00369967|B2|Baseline|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663355|NCT00369967|B1|Baseline|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663356|NCT00369967|P2|Participant Flow|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663357|NCT00369967|P1|Participant Flow|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663358|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663359|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663360|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663361|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663362|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663367|NCT00369967|O1|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663368|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception
663369|NCT00369967|O1|Outcome|Quick Start|"Start method day of enrollment~NuvaRing: Initiation of NuvaRing for contraception"
663370|NCT00369967|E2|Reported Event|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
663371|NCT00369967|E1|Reported Event|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
663372|NCT00369941|B3|Baseline|Total|Total of all reporting groups
663373|NCT00369941|B2|Baseline|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663374|NCT00369941|B1|Baseline|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663375|NCT00369941|P2|Participant Flow|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663376|NCT00369941|P1|Participant Flow|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663377|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663378|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663379|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663380|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663381|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663382|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663383|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663384|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663385|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663537|NCT00369928|E1|Reported Event|Placebo|Placebo, oral dose, BID
663538|NCT00369915|B3|Baseline|Total|Total of all reporting groups
671526|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
663386|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663387|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663388|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663389|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663390|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663391|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663392|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663393|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663394|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663395|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663396|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663397|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663398|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663399|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663539|NCT00369915|B2|Baseline|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
663540|NCT00369915|B1|Baseline|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
671527|NCT00349908|O1|Outcome|Group 1|Atherosclerosis Arm
663400|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663401|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663402|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663403|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663404|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663405|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663406|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663407|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663408|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663409|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663410|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663411|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663412|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663413|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663541|NCT00369915|P2|Participant Flow|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
663542|NCT00369915|P1|Participant Flow|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
671985|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
663414|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663415|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663416|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663417|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663418|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663419|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663420|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663421|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663422|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663423|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663424|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663425|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663426|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663427|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663543|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
663544|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
671986|NCT00348283|O1|Outcome|Placebo|
663428|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663429|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663430|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663431|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663432|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663433|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663434|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663435|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663436|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663437|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663438|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663439|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663440|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663441|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663545|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
663546|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
674921|NCT00335452|B3|Baseline|Clopidogrel 600/150/75 mg + ASA Low Dose|
663442|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663443|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663444|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663445|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663446|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663447|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663448|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663449|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663450|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663451|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663452|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663453|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663454|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663455|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663547|NCT00369915|E2|Reported Event|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
663548|NCT00369915|E1|Reported Event|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
663549|NCT00369824|B7|Baseline|Total|Total of all reporting groups
663456|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663457|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663458|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663459|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663460|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663461|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663462|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663463|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663464|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663465|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663466|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663467|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663468|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663469|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663550|NCT00369824|B6|Baseline|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663551|NCT00369824|B5|Baseline|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663552|NCT00369824|B4|Baseline|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
674922|NCT00335452|B2|Baseline|Clopidogrel 300/75/75 mg + ASA High Dose|
663470|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663471|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663472|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663473|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663474|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663475|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663476|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663477|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663478|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663479|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663480|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663481|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663482|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663483|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663553|NCT00369824|B3|Baseline|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663554|NCT00369824|B2|Baseline|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663962|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
663484|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663485|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663486|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663487|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663488|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663489|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663490|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663491|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663492|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663493|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663494|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663495|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663496|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663497|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663555|NCT00369824|B1|Baseline|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663556|NCT00369824|P6|Participant Flow|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663557|NCT00369824|P5|Participant Flow|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663498|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663499|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663500|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663501|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663502|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663503|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663504|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663505|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663506|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663507|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663508|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663509|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663510|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663511|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663558|NCT00369824|P4|Participant Flow|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663559|NCT00369824|P3|Participant Flow|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663606|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663512|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663513|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663514|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663515|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663516|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663517|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663518|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663519|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663520|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663521|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663522|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663523|NCT00369941|E2|Reported Event|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg taken by mouth on an empty stomach preferably at bedtime (q.h.s.), and placebo to MK-0518 taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663524|NCT00369941|E1|Reported Event|MK-0518 400 mg b.i.d.|MK-0518 400 mg taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, taken PO (q.h.s.) on an empty stomach preferably at bedtime (q.h.s.). All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily with food with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
663525|NCT00369928|B4|Baseline|Total|Total of all reporting groups
663526|NCT00369928|B3|Baseline|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
663527|NCT00369928|B2|Baseline|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
663528|NCT00369928|B1|Baseline|Placebo|Placebo, oral dose, BID
663529|NCT00369928|P3|Participant Flow|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
663530|NCT00369928|P2|Participant Flow|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
663531|NCT00369928|P1|Participant Flow|Placebo|Placebo, oral dose, BID
663532|NCT00369928|O3|Outcome|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
663533|NCT00369928|O2|Outcome|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
663534|NCT00369928|O1|Outcome|Placebo|Placebo, oral dose, BID
663560|NCT00369824|P2|Participant Flow|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663561|NCT00369824|P1|Participant Flow|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663562|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663563|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663564|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663565|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663566|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663567|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663568|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663569|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663570|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663571|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663572|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663573|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663574|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663575|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663576|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663577|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663578|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663579|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663580|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663581|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663582|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663583|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663584|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663585|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663586|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663587|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663588|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663589|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663590|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663591|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663592|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663593|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663594|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663595|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663596|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663597|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663598|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663599|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663600|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663601|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663602|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663603|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663604|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663605|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663607|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663608|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663609|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663610|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663611|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663612|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663613|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663614|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663615|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663616|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663617|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663618|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663619|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663620|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663621|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663622|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663623|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663624|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663625|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663626|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663627|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663628|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663629|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663630|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663631|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663632|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663633|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663634|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663635|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663636|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663637|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663638|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663639|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663640|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663641|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663642|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663643|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663644|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663645|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663646|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663647|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663648|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663649|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663650|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663651|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663652|NCT00369824|E6|Reported Event|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
663653|NCT00369824|E5|Reported Event|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
663654|NCT00369824|E4|Reported Event|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
663655|NCT00369824|E3|Reported Event|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
663656|NCT00369824|E2|Reported Event|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
663657|NCT00369824|E1|Reported Event|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
663658|NCT00369785|B3|Baseline|Total|Total of all reporting groups
663659|NCT00369785|B2|Baseline|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
663660|NCT00369785|B1|Baseline|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
663661|NCT00369785|P2|Participant Flow|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
663662|NCT00369785|P1|Participant Flow|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
663663|NCT00369785|O2|Outcome|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
663664|NCT00369785|O1|Outcome|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
663665|NCT00369785|O2|Outcome|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
663666|NCT00369785|O1|Outcome|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
663667|NCT00369785|E2|Reported Event|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
663668|NCT00369785|E1|Reported Event|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
663669|NCT00369746|B3|Baseline|Total|Total of all reporting groups
663670|NCT00369746|B2|Baseline|Major Depression Only|Major Depression without alcohol abuse disorder
663671|NCT00369746|B1|Baseline|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
663672|NCT00369746|P2|Participant Flow|Major Depression Only|Major Depression without alcohol abuse disorder
663673|NCT00369746|P1|Participant Flow|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence and Major Depression
663674|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
663675|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
663676|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
663677|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
663678|NCT00369746|O2|Outcome|Major Depression Only|citalopram (Non alcoholic)
663679|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
663680|NCT00369746|E2|Reported Event|Major Depression Only|Major Depression without alcohol abuse disorder
663681|NCT00369746|E1|Reported Event|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
663682|NCT00369681|B1|Baseline|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
663683|NCT00369681|P1|Participant Flow|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
663684|NCT00369681|O1|Outcome|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
663685|NCT00369681|O2|Outcome|Re-emergence of Clone|Participants who did have re-emergence of clonal CD27(+) ALDH(+) B cells
663686|NCT00369681|O1|Outcome|No Clone|Participants who did not have re-emergence of clonal CD27(+) ALDH(+) B cells
663687|NCT00369681|E1|Reported Event|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
663688|NCT00369668|B4|Baseline|Total|Total of all reporting groups
663689|NCT00369668|B3|Baseline|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
663690|NCT00369668|B2|Baseline|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
663691|NCT00369668|B1|Baseline|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
663692|NCT00369668|P3|Participant Flow|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
663693|NCT00369668|P2|Participant Flow|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
663694|NCT00369668|P1|Participant Flow|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
663695|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
663696|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
663697|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
663698|NCT00369668|O3|Outcome|Control|Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks.
663699|NCT00369668|O2|Outcome|Low Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks.
663700|NCT00369668|O1|Outcome|High Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks.
663701|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
663702|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
663703|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
663704|NCT00369668|E3|Reported Event|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
663705|NCT00369668|E2|Reported Event|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
663706|NCT00369668|E1|Reported Event|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
663707|NCT00369655|B1|Baseline|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663708|NCT00369655|P1|Participant Flow|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663709|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663710|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663711|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663712|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663713|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663714|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663715|NCT00369655|E1|Reported Event|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
663716|NCT00369590|B3|Baseline|Total|Total of all reporting groups
663717|NCT00369590|B2|Baseline|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663718|NCT00369590|B1|Baseline|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663719|NCT00369590|P2|Participant Flow|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663720|NCT00369590|P1|Participant Flow|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663721|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663722|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663723|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663724|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663795|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
664085|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
663725|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663726|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663727|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663728|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663729|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663730|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663731|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663732|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663733|NCT00369590|E1|Reported Event|All Study Patients|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
663734|NCT00369577|B4|Baseline|Total|Total of all reporting groups
663735|NCT00369577|B3|Baseline|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
663736|NCT00369577|B2|Baseline|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
663737|NCT00369577|B1|Baseline|Inhaled Placebo|Inhaled Staccato Placebo, single dose
663738|NCT00369577|P3|Participant Flow|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
663739|NCT00369577|P2|Participant Flow|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
663740|NCT00369577|P1|Participant Flow|Inhaled Placebo|Inhaled Staccato Placebo, single dose
663741|NCT00369577|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
663742|NCT00369577|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
663743|NCT00369577|O1|Outcome|Inhaled Placebo|Inhaled Staccato Placebo, single dose
663744|NCT00369577|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
663745|NCT00369577|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
663746|NCT00369577|O1|Outcome|Inhaled Placebo|Inhaled Staccato Placebo, single dose
663747|NCT00369577|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
663748|NCT00369577|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
663749|NCT00369577|O1|Outcome|Inhaled Placebo|Inhaled Staccato Placebo, single dose
663750|NCT00369577|O3|Outcome|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
663751|NCT00369577|O2|Outcome|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
663752|NCT00369577|O1|Outcome|Inhaled Placebo|Inhaled Staccato Placebo, single dose
663753|NCT00369577|E3|Reported Event|Inhaled Loxapine 10 mg|Inhaled Staccato Loxapine 10 mg, single dose
663754|NCT00369577|E2|Reported Event|Inhaled Loxapine 5 mg|Inhaled Staccato Loxapine 5 mg, single dose
663755|NCT00369577|E1|Reported Event|Inhaled Placebo|Inhaled Staccato Placebo, single dose
663756|NCT00369564|B3|Baseline|Total|Total of all reporting groups
663757|NCT00369564|B2|Baseline|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
663758|NCT00369564|B1|Baseline|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
663759|NCT00369564|P2|Participant Flow|Arm II Placebo|"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent.~Patients with a body surface area (BSA) less than 1.0 m^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). ."
664874|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
663760|NCT00369564|P1|Participant Flow|Arm I Glutamic Acid|Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a total of 1500 mg/day of oral glutamic acid .
663761|NCT00369564|O2|Outcome|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
663762|NCT00369564|O1|Outcome|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
663763|NCT00369564|E2|Reported Event|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
663764|NCT00369564|E1|Reported Event|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
663765|NCT00369512|B1|Baseline|Erlotinib|Erlotinib therapy for 2 weeks (150 mg once per day)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg once per day).
663766|NCT00369512|P1|Participant Flow|Erlotinib|Erlotinib therapy for 2 weeks (150 mg by mouth (PO) every day(QD))(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
663767|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
663768|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
663769|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
663770|NCT00369512|E1|Reported Event|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
663771|NCT00369486|B6|Baseline|Total|Total of all reporting groups
663772|NCT00369486|B5|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663773|NCT00369486|B4|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663774|NCT00369486|B3|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663775|NCT00369486|B2|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663776|NCT00369486|B1|Baseline|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663777|NCT00369486|P5|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663778|NCT00369486|P4|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663779|NCT00369486|P3|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663780|NCT00369486|P2|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663781|NCT00369486|P1|Participant Flow|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663782|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663783|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663784|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663785|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663786|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663787|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663788|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663789|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663790|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663791|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663792|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663793|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663794|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663796|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663797|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663798|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663799|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663800|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663801|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663802|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663803|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663804|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663805|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663806|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663807|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663808|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663809|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663810|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663811|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663812|NCT00369486|E5|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
663813|NCT00369486|E4|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
663814|NCT00369486|E3|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
663815|NCT00369486|E2|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
663816|NCT00369486|E1|Reported Event|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
663817|NCT00369382|B3|Baseline|Total|Total of all reporting groups
663818|NCT00369382|B2|Baseline|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663819|NCT00369382|B1|Baseline|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663820|NCT00369382|P2|Participant Flow|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663821|NCT00369382|P1|Participant Flow|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663822|NCT00369382|O1|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663823|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663824|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663825|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
664920|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
663826|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663827|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663828|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663829|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663830|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663831|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663832|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663833|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663834|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663835|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663836|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663837|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663838|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663839|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663840|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663841|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663842|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663843|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663870|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
664086|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
663844|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663845|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663846|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663847|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663848|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663849|NCT00369382|E2|Reported Event|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
663850|NCT00369382|E1|Reported Event|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
663851|NCT00369343|B3|Baseline|Total|Total of all reporting groups
663852|NCT00369343|B2|Baseline|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663853|NCT00369343|B1|Baseline|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663854|NCT00369343|P2|Participant Flow|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663855|NCT00369343|P1|Participant Flow|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663856|NCT00369343|O3|Outcome|200 mg|DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
663857|NCT00369343|O2|Outcome|100 mg|DVS SR 100mg dosage was reduced to DVS SR 50mg for 7 days.
663858|NCT00369343|O1|Outcome|0 mg|Placebo
663859|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
663860|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
663861|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
663862|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
663863|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
663864|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
663865|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
663866|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
663867|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
663868|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
663869|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
663871|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663872|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663873|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663874|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663875|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663876|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663877|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663878|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663879|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663880|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663881|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663882|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
663883|NCT00369343|E4|Reported Event|Open-label Placebo/DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
663884|NCT00369343|E3|Reported Event|Open-label DVS SR/ DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
663885|NCT00369343|E2|Reported Event|Double-blind Placebo|Placebo administered daily for 8 weeks
663886|NCT00369343|E1|Reported Event|Double-blind DVS SR|"Days 1 to 7:~Patients will be instructed to take 1-50mg tablet per day~Days 8 to 14:~Patients will be instructed to take 1-100mg tablet per day~Days 15 to 56:~At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day"
663887|NCT00369317|B1|Baseline|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
663888|NCT00369317|P1|Participant Flow|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
663889|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663890|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
663891|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
663892|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663893|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663905|NCT00369278|P1|Participant Flow|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663894|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663895|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663896|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663897|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663898|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663899|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4.~COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies"
663900|NCT00369317|E1|Reported Event|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
663901|NCT00369278|B3|Baseline|Total|Total of all reporting groups
663902|NCT00369278|B2|Baseline|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
663903|NCT00369278|B1|Baseline|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663904|NCT00369278|P2|Participant Flow|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
664921|NCT00365859|O4|Outcome|Total|
663906|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
663907|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663908|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
663909|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663910|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
663911|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663912|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
663913|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663914|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
663915|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663916|NCT00369278|E2|Reported Event|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study (month 6): 1440 mg/day (2 x 720 mg)
663917|NCT00369278|E1|Reported Event|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
663918|NCT00369265|B3|Baseline|Total|Total of all reporting groups
663919|NCT00369265|B2|Baseline|Lansoprazole|Lansoprazole 30 mg twice daily
663920|NCT00369265|B1|Baseline|Sugar Pill|Placebo for Lansoprazole twice daily
663921|NCT00369265|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg twice daily
663922|NCT00369265|P1|Participant Flow|Sugar Pill|Placebo for Lansoprazole twice daily
663923|NCT00369265|O2|Outcome|Lansoprazole|Lansoprazole 30 mg twice daily
663924|NCT00369265|O1|Outcome|Sugar Pill|Placebo for Lansoprazole twice daily
663925|NCT00369265|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg twice daily
663926|NCT00369265|E1|Reported Event|Sugar Pill|Placebo for Lansoprazole twice daily
663927|NCT00369226|B3|Baseline|Total|Total of all reporting groups
663928|NCT00369226|B2|Baseline|Phase II|
663929|NCT00369226|B1|Baseline|Phase I|
663930|NCT00369226|P2|Participant Flow|Phase II (45 Days)|
663931|NCT00369226|P1|Participant Flow|Phase I (45 Days)|Bortezomib plus tacrolimus and methotrexate after mismatched allogeneic non-myeloablative hematopoietic stem cell transplantation (HSCT).
663932|NCT00369226|O2|Outcome|Overall Survival (OS)|This reports on all treated patients across both phase I and phase II (n=45)
663933|NCT00369226|O1|Outcome|Progression-free Survival (PFS)|This reports on all treated patients across both phase I and phase II (n=45)
663934|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
663935|NCT00369226|O1|Outcome|Phase I and Phase II|Engraftment is determined for all treated patients across both phase I and phase II (n=45) who are evaluable for this endpoint (n=35)
663936|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
663937|NCT00369226|O1|Outcome|Combined Phase I Plus Phase II|This reports on the total phase I plus phase II patients who were evaluable for chimerism endpoint (37 of the 45 patients).
663938|NCT00369226|O1|Outcome|Phase I|
663939|NCT00369226|E1|Reported Event|Phase I-II|
663940|NCT00369161|B3|Baseline|Total|Total of all reporting groups
663941|NCT00369161|B2|Baseline|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663959|NCT00369122|E1|Reported Event|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.~Data is reported for all patients who received study treatment, which is 59 patients."
663960|NCT00368992|B1|Baseline|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
663942|NCT00369161|B1|Baseline|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663943|NCT00369161|P2|Participant Flow|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663944|NCT00369161|P1|Participant Flow|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663945|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663946|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663947|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663948|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663961|NCT00368992|P1|Participant Flow|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|"This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
663949|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663950|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663951|NCT00369161|E2|Reported Event|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663952|NCT00369161|E1|Reported Event|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
663953|NCT00369122|B1|Baseline|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
663954|NCT00369122|P1|Participant Flow|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
663955|NCT00369122|O1|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
663956|NCT00369122|O1|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
663957|NCT00369122|O1|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
663958|NCT00369122|O1|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
663963|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
663964|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
663965|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
663966|NCT00368992|E1|Reported Event|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
663967|NCT00368979|B3|Baseline|Total|Total of all reporting groups
663968|NCT00368979|B2|Baseline|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663969|NCT00368979|B1|Baseline|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663970|NCT00368979|P2|Participant Flow|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663971|NCT00368979|P1|Participant Flow|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663972|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663973|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663974|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663975|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663976|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663977|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663978|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663979|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663980|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663981|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663982|NCT00368979|E2|Reported Event|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663983|NCT00368979|E1|Reported Event|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
663984|NCT00368966|B3|Baseline|Total|Total of all reporting groups
663985|NCT00368966|B2|Baseline|7vPnC|Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.
663986|NCT00368966|B1|Baseline|13vPnC|Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.
663987|NCT00368966|P2|Participant Flow|7vPnC|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
663988|NCT00368966|P1|Participant Flow|13vPnC|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
663989|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
663990|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
663991|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
663992|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
663993|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
663994|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
674923|NCT00335452|B1|Baseline|Clopidogrel 300/75/75 mg + ASA Low Dose|
663995|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
663996|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
663997|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
663998|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
663999|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
664000|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664001|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664002|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
664003|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
664004|NCT00368966|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months.
664005|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664006|NCT00368966|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
664007|NCT00368966|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
664008|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664009|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
664010|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).
664011|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664012|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664013|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
664014|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
664015|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
664016|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
664017|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
664018|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
664019|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664020|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664021|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
664022|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
664023|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
664024|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
664025|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
664026|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
664027|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664028|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664029|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664030|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months(toddler dose).
664031|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664032|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
664033|NCT00368966|E8|Reported Event|7vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.
664034|NCT00368966|E7|Reported Event|13vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.
664035|NCT00368966|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
664036|NCT00368966|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
664037|NCT00368966|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.
664038|NCT00368966|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.
664039|NCT00368966|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
664040|NCT00368966|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
664041|NCT00368940|B3|Baseline|Total|Total of all reporting groups
664042|NCT00368940|B2|Baseline|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
664043|NCT00368940|B1|Baseline|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
664044|NCT00368940|P2|Participant Flow|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
664045|NCT00368940|P1|Participant Flow|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
664046|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
664047|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
664048|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
664049|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
664050|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
664051|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
664052|NCT00368940|O2|Outcome|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
664053|NCT00368940|O1|Outcome|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
664054|NCT00368940|E2|Reported Event|ST-CI|"Participants will receive ST-CI for 12 weeks~ST-CI: Supportive therapy focuses on the use of nonspecific or common factors of therapy, including facilitation of affect, helping the person feel understood, empathy, the treatment ritual, success experiences, and therapeutic optimism. In working with the participant, the therapist creates a supportive relationship and encourages the participant to consider his/her strengths and abilities rather than focusing on negative aspects of his/her character."
664055|NCT00368940|E1|Reported Event|PATH|"Participants will receive PATH for 12 weeks~PATH: PATH aims to improve emotion regulation and reduce the negative impact of behavioral and functional limitations. The strategies of PATH are consistent with the process model of emotion regulation. PATH utilizes a problem solving approach based on Problem Solving Therapy (PST) and identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies and environmental adaptations that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment. PATH also incorporates caregiver involvement to help patient reduce depression and improve functioning."
664056|NCT00368927|B3|Baseline|Total|Total of all reporting groups
664057|NCT00368927|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
664058|NCT00368927|B1|Baseline|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
664059|NCT00368927|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
664060|NCT00368927|P1|Participant Flow|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
664061|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
664062|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
664063|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
664064|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
664065|NCT00368927|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
664066|NCT00368927|E1|Reported Event|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
664087|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
664088|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine
664089|NCT00368849|E2|Reported Event|Matching Placebo|Individuals in this arm received twice a day matching placebo.
664090|NCT00368849|E1|Reported Event|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
664091|NCT00368745|B3|Baseline|Total|Total of all reporting groups
664067|NCT00368875|B1|Baseline|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
664068|NCT00368875|P2|Participant Flow|Phase II|"Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
664069|NCT00368875|P1|Participant Flow|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
664070|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
664071|NCT00368875|O1|Outcome|Vorinostat, Paclitaxel, Bevacizumab|"Vorinostat BID on days 1-3, 8-10, and 15-17, paclitaxel IV over 1 hour on days 2, 9, and 16, bevacizumab IV over 30-90 minutes on days 2 and 16, repeat every 28 days.~vorinostat: Given orally~paclitaxel: Given IV~bevacizumab: Given IV"
664072|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
664073|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
664074|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
664075|NCT00368875|E1|Reported Event|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
664076|NCT00368849|B1|Baseline|All Participants|Age, sex, and region of enrollment were available for all 20 participants.
664077|NCT00368849|P2|Participant Flow|Placebo (4 Weeks) Then Atomoxetine (4 Weeks)|Participants received twice a day matching placebo for four weeks. After a two week washout, they then received 40 milligram twice a day atomoxetine for four weeks.
664078|NCT00368849|P1|Participant Flow|Atomoxetine (4 Weeks) Then Placebo (4 Weeks)|Participants received 40 milligram twice a day atomoxetine for four weeks. After a two week wash out, they then received twice a day matching placebo for four weeks.
664079|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
664080|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
664081|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
664082|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
664083|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
664084|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
664133|NCT00368550|B3|Baseline|Total|Total of all reporting groups
664092|NCT00368745|B2|Baseline|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664093|NCT00368745|B1|Baseline|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664094|NCT00368745|P2|Participant Flow|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664095|NCT00368745|P1|Participant Flow|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664096|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664097|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664098|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664099|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664100|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664101|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664102|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664134|NCT00368550|B2|Baseline|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664103|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664104|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664105|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664106|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664107|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664108|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664109|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664110|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664111|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664112|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664113|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664166|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
664114|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664115|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664116|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664117|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664118|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664119|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664120|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664121|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664122|NCT00368745|E2|Reported Event|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
664123|NCT00368745|E1|Reported Event|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
664124|NCT00368641|B3|Baseline|Total|Total of all reporting groups
664125|NCT00368641|B2|Baseline|Standard Therapy|Standard therapy for CHF
664126|NCT00368641|B1|Baseline|Intervention Group|Addition of peritoneal ultrafiltration
664127|NCT00368641|P2|Participant Flow|Standard Therapy|Standard therapy for CHF
664128|NCT00368641|P1|Participant Flow|Intervention Group|Addition of peritoneal ultrafiltration
664129|NCT00368641|O2|Outcome|Standard Therapy|Standard therapy for CHF
664130|NCT00368641|O1|Outcome|Intervention Group|Addition of peritoneal ultrafiltration
664131|NCT00368641|E2|Reported Event|Standard Therapy|Standard therapy for CHF
664132|NCT00368641|E1|Reported Event|Intervention Group|Addition of peritoneal ultrafiltration
664135|NCT00368550|B1|Baseline|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664136|NCT00368550|P2|Participant Flow|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664137|NCT00368550|P1|Participant Flow|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664138|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664139|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664140|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664141|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664142|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664143|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664144|NCT00368550|E2|Reported Event|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664145|NCT00368550|E1|Reported Event|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
664146|NCT00368537|B3|Baseline|Total|Total of all reporting groups
664147|NCT00368537|B2|Baseline|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664148|NCT00368537|B1|Baseline|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664149|NCT00368537|P2|Participant Flow|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664150|NCT00368537|P1|Participant Flow|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664151|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664152|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664153|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664154|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664155|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664156|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664157|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664158|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664159|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664160|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664161|NCT00368537|E2|Reported Event|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
664162|NCT00368537|E1|Reported Event|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
664163|NCT00368472|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
664164|NCT00368472|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
664165|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
664245|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664167|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
664168|NCT00368472|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
664169|NCT00368459|B3|Baseline|Total|Total of all reporting groups
664170|NCT00368459|B2|Baseline|Placebo|identical appearing oral placebo
664171|NCT00368459|B1|Baseline|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664172|NCT00368459|P2|Participant Flow|Placebo|identical appearing oral placebo
664173|NCT00368459|P1|Participant Flow|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664174|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664175|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664176|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664177|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664178|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664179|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664180|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664181|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664182|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664183|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664184|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664185|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664186|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664187|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664188|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664189|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664190|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664191|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664192|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
664193|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664194|NCT00368459|E2|Reported Event|Placebo|identical appearing oral placebo
664195|NCT00368459|E1|Reported Event|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
664196|NCT00368316|B3|Baseline|Total|Total of all reporting groups
664197|NCT00368316|B2|Baseline|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664198|NCT00368316|B1|Baseline|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664199|NCT00368316|P2|Participant Flow|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664200|NCT00368316|P1|Participant Flow|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664201|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664202|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664203|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664204|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664205|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664206|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664207|NCT00368316|E2|Reported Event|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664208|NCT00368316|E1|Reported Event|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
664209|NCT00368290|B3|Baseline|Total|Total of all reporting groups
664210|NCT00368290|B2|Baseline|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664211|NCT00368290|B1|Baseline|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664212|NCT00368290|P2|Participant Flow|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664246|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664213|NCT00368290|P1|Participant Flow|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664214|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664215|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664216|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664217|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664218|NCT00368290|E2|Reported Event|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664219|NCT00368290|E1|Reported Event|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
664220|NCT00368277|B3|Baseline|Total|Total of all reporting groups
664221|NCT00368277|B2|Baseline|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
664222|NCT00368277|B1|Baseline|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
664223|NCT00368277|P2|Participant Flow|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
664224|NCT00368277|P1|Participant Flow|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
664225|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
664226|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
664227|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
664228|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
664229|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
664230|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
664231|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
664232|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
664233|NCT00368277|E2|Reported Event|Ramipril|Ramipril based regimen
664234|NCT00368277|E1|Reported Event|Aliskiren|Aliskiren based regimen
664235|NCT00368251|B4|Baseline|Total Title|
664236|NCT00368251|B3|Baseline|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664237|NCT00368251|B2|Baseline|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664238|NCT00368251|B1|Baseline|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664239|NCT00368251|P3|Participant Flow|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664240|NCT00368251|P2|Participant Flow|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664241|NCT00368251|P1|Participant Flow|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664242|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664243|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664244|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664247|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664248|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664249|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664250|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664251|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664252|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664253|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664254|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664255|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664256|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664257|NCT00368251|E3|Reported Event|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
664258|NCT00368251|E2|Reported Event|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
664259|NCT00368251|E1|Reported Event|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
664260|NCT00368108|B4|Baseline|Total|Total of all reporting groups
664261|NCT00368108|B3|Baseline|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
664262|NCT00368108|B2|Baseline|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
664263|NCT00368108|B1|Baseline|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
664264|NCT00368108|P3|Participant Flow|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
664265|NCT00368108|P2|Participant Flow|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
664266|NCT00368108|P1|Participant Flow|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
664267|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
664268|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
664269|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
664270|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
664271|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
664272|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
664273|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
664274|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
664275|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
664276|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
664277|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
664278|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
664404|NCT00367601|O1|Outcome|Single Arm|Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
664279|NCT00368108|E3|Reported Event|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
664280|NCT00368108|E2|Reported Event|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
664281|NCT00368108|E1|Reported Event|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
664282|NCT00368069|B3|Baseline|Total|Total of all reporting groups
664283|NCT00368069|B2|Baseline|Placebo|placebo
664284|NCT00368069|B1|Baseline|Keppra®|Keppra® extended release formulation (XR)
664285|NCT00368069|P2|Participant Flow|Placebo|placebo
664286|NCT00368069|P1|Participant Flow|Keppra®|Keppra® extended release formulation (XR)
664287|NCT00368069|O2|Outcome|Placebo|placebo
664288|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
664289|NCT00368069|O2|Outcome|Placebo|placebo
664290|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
664291|NCT00368069|O2|Outcome|Placebo|placebo
664292|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
664293|NCT00368069|O2|Outcome|Placebo|placebo
664294|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
664295|NCT00368069|O2|Outcome|Placebo|placebo
664296|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
664297|NCT00368069|O2|Outcome|Placebo|placebo
664298|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
664299|NCT00368069|E2|Reported Event|Placebo|placebo
664300|NCT00368069|E1|Reported Event|Keppra®|Keppra® extended release formulation (XR)
664301|NCT00367991|B3|Baseline|Total|Total of all reporting groups
664302|NCT00367991|B2|Baseline|Placebo|Normal saline volume to match active treatment IV daily for 3 days
664303|NCT00367991|B1|Baseline|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
664304|NCT00367991|P2|Participant Flow|Placebo|Normal saline volume to match active treatment IV daily for 3 days
664305|NCT00367991|P1|Participant Flow|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
664306|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
664307|NCT00367991|O1|Outcome|Placebo|normal saline
664308|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
664309|NCT00367991|O1|Outcome|Placebo|normal saline
664310|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
664311|NCT00367991|O1|Outcome|Placebo|normal saline
664312|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
664313|NCT00367991|O1|Outcome|Placebo|normal saline
664314|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
664315|NCT00367991|O1|Outcome|Placebo|normal saline
664316|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
664317|NCT00367991|O1|Outcome|Placebo|normal saline
664318|NCT00367991|E2|Reported Event|Placebo|Normal saline volume to match active treatment IV daily for 3 days
664319|NCT00367991|E1|Reported Event|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
664320|NCT00367835|B3|Baseline|Total|Total of all reporting groups
664321|NCT00367835|B2|Baseline|Placebo|
664322|NCT00367835|B1|Baseline|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664323|NCT00367835|P2|Participant Flow|Placebo|
664324|NCT00367835|P1|Participant Flow|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664325|NCT00367835|O2|Outcome|Placebo|
664326|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664327|NCT00367835|O2|Outcome|Placebo|
664328|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664329|NCT00367835|O2|Outcome|Placebo|
664330|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664331|NCT00367835|O2|Outcome|Placebo|
664332|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664333|NCT00367835|O2|Outcome|Placebo|
664334|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664335|NCT00367835|O2|Outcome|Placebo|
664336|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664337|NCT00367835|O2|Outcome|Placebo|
664338|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664339|NCT00367835|O2|Outcome|Placebo|
664340|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664341|NCT00367835|O2|Outcome|Placebo|
664342|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664343|NCT00367835|O2|Outcome|Placebo|
664344|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664345|NCT00367835|O2|Outcome|Placebo|
664346|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664347|NCT00367835|E2|Reported Event|Placebo|
664348|NCT00367835|E1|Reported Event|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
664349|NCT00367770|B1|Baseline|Overall Study Arm|
664350|NCT00367770|P1|Participant Flow|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
664351|NCT00367770|O1|Outcome|Overall Study Arm|
664352|NCT00367770|O1|Outcome|Overall Study Arm|
664353|NCT00367770|O1|Outcome|Overall Study Arm|
664354|NCT00367770|E1|Reported Event|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
664355|NCT00367744|B3|Baseline|Total|Total of all reporting groups
664356|NCT00367744|B2|Baseline|Placebo|Placebo arm
664357|NCT00367744|B1|Baseline|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks)
664358|NCT00367744|P2|Participant Flow|Placebo|Placebo arm for the whole duration of the study
664359|NCT00367744|P1|Participant Flow|Rosiglitazone|Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
664360|NCT00367744|O2|Outcome|Placebo|Placebo arm
664361|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
664362|NCT00367744|O2|Outcome|Placebo|Placebo arm
664363|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then BID for 44 weeks
664364|NCT00367744|E2|Reported Event|Placebo|Placebo arm
664365|NCT00367744|E1|Reported Event|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
664366|NCT00367679|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664367|NCT00367679|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664368|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664369|NCT00367679|O1|Outcome|Overall Study Arm|
664370|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664371|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664372|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664373|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664374|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
664375|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664376|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
664377|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
664378|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
664379|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664380|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664381|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664382|NCT00367679|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
664383|NCT00367640|B5|Baseline|Total|Total of all reporting groups
664384|NCT00367640|B4|Baseline|Placebo|Placebo tablet
664385|NCT00367640|B3|Baseline|500 IR|500 IR grass pollen allergen extract tablet
664386|NCT00367640|B2|Baseline|300 IR|300 IR grass pollen allergen extract tablet
664387|NCT00367640|B1|Baseline|100 IR|100 IR grass pollen allergen extract tablet
664388|NCT00367640|P4|Participant Flow|Placebo|Placebo tablet
664389|NCT00367640|P3|Participant Flow|500 IR|500 IR grass pollen allergen extract tablet
664390|NCT00367640|P2|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
664391|NCT00367640|P1|Participant Flow|100 IR|100 IR grass pollen allergen extract tablet
664392|NCT00367640|O4|Outcome|Placebo|Placebo tablet
664393|NCT00367640|O3|Outcome|500 IR|500 IR grass pollen allergen extract tablet
664394|NCT00367640|O2|Outcome|300 IR|300 IR grass pollen allergen extract tablet
664395|NCT00367640|O1|Outcome|100 IR|100 IR grass pollen allergen extract tablet
664396|NCT00367640|E4|Reported Event|Placebo|Placebo tablet
664397|NCT00367640|E3|Reported Event|100 IR|100 IR grass pollen allergen extract tablet
664398|NCT00367640|E2|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
664399|NCT00367640|E1|Reported Event|500 IR|500 IR grass pollen allergen extract tablet
664400|NCT00367601|B1|Baseline|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
664401|NCT00367601|P1|Participant Flow|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
664402|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
664403|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
664405|NCT00367601|E1|Reported Event|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
664406|NCT00367484|B1|Baseline|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
664407|NCT00367484|P1|Participant Flow|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
664408|NCT00367484|O1|Outcome|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
664409|NCT00367484|E1|Reported Event|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
664410|NCT00367432|B1|Baseline|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664411|NCT00367432|P2|Participant Flow|Levetiracetam N01020 [NCT00160615]|N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
664412|NCT00367432|P1|Participant Flow|Levetiracetam N01221 [NCT00280696]|N01221 [NCT00280696] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
664413|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664414|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664415|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664416|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664417|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664418|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664419|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664420|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664421|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664422|NCT00367432|E1|Reported Event|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
664423|NCT00367380|B4|Baseline|Total|Total of all reporting groups
664424|NCT00367380|B3|Baseline|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
664425|NCT00367380|B2|Baseline|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
664426|NCT00367380|B1|Baseline|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
664427|NCT00367380|P3|Participant Flow|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
664428|NCT00367380|P2|Participant Flow|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
664429|NCT00367380|P1|Participant Flow|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
664430|NCT00367380|O3|Outcome|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
664431|NCT00367380|O2|Outcome|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
664432|NCT00367380|O1|Outcome|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
664433|NCT00367380|E3|Reported Event|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
664434|NCT00367380|E2|Reported Event|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
664435|NCT00367380|E1|Reported Event|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
664436|NCT00367341|B3|Baseline|Total|Total of all reporting groups
664437|NCT00367341|B2|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
664438|NCT00367341|B1|Baseline|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
664439|NCT00367341|P2|Participant Flow|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
664440|NCT00367341|P1|Participant Flow|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
664441|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
664442|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
664443|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
664444|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
664445|NCT00367341|E2|Reported Event|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
664446|NCT00367341|E1|Reported Event|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
664447|NCT00367237|B3|Baseline|Total|Total of all reporting groups
664448|NCT00367237|B2|Baseline|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
664449|NCT00367237|B1|Baseline|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
664450|NCT00367237|P2|Participant Flow|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
664451|NCT00367237|P1|Participant Flow|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
664452|NCT00367237|O2|Outcome|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
664453|NCT00367237|O1|Outcome|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
664454|NCT00367237|E2|Reported Event|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
664455|NCT00367237|E1|Reported Event|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
664456|NCT00367133|B4|Baseline|Total|Total of all reporting groups
664457|NCT00367133|B3|Baseline|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664458|NCT00367133|B2|Baseline|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664459|NCT00367133|B1|Baseline|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664460|NCT00367133|P3|Participant Flow|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664461|NCT00367133|P2|Participant Flow|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664462|NCT00367133|P1|Participant Flow|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664463|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664464|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664465|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664466|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664467|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664468|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664469|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664470|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664471|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664472|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664473|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664474|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664475|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664476|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664477|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664478|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664479|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664480|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664481|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664482|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664483|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664484|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664485|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664486|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664487|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664488|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664489|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664490|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664491|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664492|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664493|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664494|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664495|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664496|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664497|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664498|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664499|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664500|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664501|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664502|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664503|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664504|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664505|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664506|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664507|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664508|NCT00367133|E3|Reported Event|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
664509|NCT00367133|E2|Reported Event|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
664510|NCT00367133|E1|Reported Event|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
664511|NCT00367055|B3|Baseline|Total|Total of all reporting groups
664512|NCT00367055|B2|Baseline|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664513|NCT00367055|B1|Baseline|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664514|NCT00367055|P2|Participant Flow|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664515|NCT00367055|P1|Participant Flow|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664516|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664517|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664518|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664519|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664520|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664521|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664522|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664523|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664524|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664525|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664526|NCT00367055|E2|Reported Event|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
664527|NCT00367055|E1|Reported Event|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
664528|NCT00366899|B3|Baseline|Total|Total of all reporting groups
664529|NCT00366899|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
664530|NCT00366899|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
664531|NCT00366899|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
664532|NCT00366899|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
664533|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
664534|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
664535|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664536|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664537|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664538|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664539|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664540|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664541|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664542|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664543|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664544|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664545|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664546|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664547|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664548|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664549|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664550|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664551|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664552|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664553|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664554|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664555|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664556|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664557|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664558|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664559|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664560|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664561|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664562|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664563|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664564|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664565|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664566|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
664567|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664568|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
664569|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
664570|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
664571|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
664572|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
664573|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
664574|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
664575|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
664576|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
664577|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
664578|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
664579|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
664580|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
664581|NCT00366899|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
664582|NCT00366899|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
664583|NCT00366899|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
664584|NCT00366899|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
664585|NCT00366899|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
664586|NCT00366899|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
664587|NCT00366899|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
664588|NCT00366899|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
664589|NCT00366678|B3|Baseline|Total|Total of all reporting groups
664590|NCT00366678|B2|Baseline|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664591|NCT00366678|B1|Baseline|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664592|NCT00366678|P3|Participant Flow|7vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
664593|NCT00366678|P2|Participant Flow|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664594|NCT00366678|P1|Participant Flow|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664595|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
664596|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
664597|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
664598|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
664599|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
664600|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
664601|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
664602|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
664603|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
664604|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
664605|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
664606|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
664607|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
664608|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
664609|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
664610|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
664611|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
664612|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
664613|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
664614|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
664615|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664616|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664617|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664618|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664619|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664620|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664621|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664622|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664623|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664624|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664625|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664626|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664627|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
664628|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
664869|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664629|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
664630|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
664631|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
664632|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, 4, and 12 months of age.
664633|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
664634|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664635|NCT00366678|O6|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
664636|NCT00366678|O5|Outcome|7vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
664637|NCT00366678|O4|Outcome|7vPnC/7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
664638|NCT00366678|O3|Outcome|7vPnC/7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664639|NCT00366678|O2|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
664640|NCT00366678|O1|Outcome|13vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664641|NCT00366678|O3|Outcome|7vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
664642|NCT00366678|O2|Outcome|7vPnC Infant Series / 7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664643|NCT00366678|O1|Outcome|13vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664644|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664645|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664646|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664647|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
664648|NCT00366678|E10|Reported Event|7vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
664649|NCT00366678|E9|Reported Event|7vPnC / 7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
664650|NCT00366678|E8|Reported Event|13vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
664651|NCT00366678|E7|Reported Event|7vPnC/ 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
664652|NCT00366678|E6|Reported Event|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
664653|NCT00366678|E5|Reported Event|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
664654|NCT00366678|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
664655|NCT00366678|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
664656|NCT00366678|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
664657|NCT00366678|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
664658|NCT00366626|B3|Baseline|Total|Total of all reporting groups
664659|NCT00366626|B2|Baseline|Placebo|
664660|NCT00366626|B1|Baseline|Naltrexone|
664661|NCT00366626|P2|Participant Flow|Placebo|
664662|NCT00366626|P1|Participant Flow|Naltrexone|
664663|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
664664|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
664665|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
664666|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
664667|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
664668|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
664669|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
664670|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
664671|NCT00366626|E2|Reported Event|Placebo|
664672|NCT00366626|E1|Reported Event|Naltrexone|
664673|NCT00366548|B3|Baseline|Total|Total of all reporting groups
664674|NCT00366548|B2|Baseline|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
664675|NCT00366548|B1|Baseline|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
664676|NCT00366548|P2|Participant Flow|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
664677|NCT00366548|P1|Participant Flow|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
664678|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
664679|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
664680|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664681|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664682|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664683|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664684|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
664685|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
664686|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
664687|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
664688|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
664689|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
664690|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
664691|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
664692|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
664693|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
664694|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
664695|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
664696|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
664697|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
664698|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
664699|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
664700|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664701|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664702|NCT00366548|E8|Reported Event|13vPnC - P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664703|NCT00366548|E7|Reported Event|13vPnC + P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664704|NCT00366548|E6|Reported Event|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664705|NCT00366548|E5|Reported Event|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664706|NCT00366548|E4|Reported Event|13vPnC - P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664707|NCT00366548|E3|Reported Event|13vPnC + P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664708|NCT00366548|E2|Reported Event|13vPnC - P 80 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664709|NCT00366548|E1|Reported Event|13vPnC + P80 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
664710|NCT00366457|B1|Baseline|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
664711|NCT00366457|P1|Participant Flow|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
664870|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664712|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
664713|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
664714|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
664715|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
664716|NCT00366457|E1|Reported Event|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
664717|NCT00366444|B3|Baseline|Total|Total of all reporting groups
664718|NCT00366444|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
664719|NCT00366444|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664720|NCT00366444|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
664721|NCT00366444|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664722|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664723|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664724|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664725|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664726|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664727|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664728|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664729|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664730|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664731|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664732|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664733|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664734|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664735|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664736|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664737|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664738|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664739|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664740|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664741|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664742|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
664743|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664744|NCT00366444|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
664745|NCT00366444|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
664746|NCT00366340|B3|Baseline|Total|Total of all reporting groups
664747|NCT00366340|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
664748|NCT00366340|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
664871|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664872|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664749|NCT00366340|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
664750|NCT00366340|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
664751|NCT00366340|O2|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
664752|NCT00366340|O1|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
664753|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
664754|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
664755|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
664756|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
664757|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
664758|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
664759|NCT00366340|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
664760|NCT00366340|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
664761|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
664762|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
664763|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
664764|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
664765|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
664766|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
664767|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
664768|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
664769|NCT00366340|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664770|NCT00366340|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
675577|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
664771|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
664772|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
664773|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664774|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664775|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
664776|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
664777|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664778|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664779|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
664780|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
664781|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664782|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664783|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
664784|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
664785|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664786|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
664787|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
664788|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
664789|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
664790|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
664791|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
664922|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664792|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
664793|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
664794|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
664795|NCT00366340|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
664796|NCT00366340|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
664797|NCT00366340|E6|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
664798|NCT00366340|E5|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
664799|NCT00366340|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
664800|NCT00366340|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
664801|NCT00366340|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
664802|NCT00366340|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
664803|NCT00366301|B5|Baseline|Total|Total of all reporting groups
664804|NCT00366301|B4|Baseline|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
664805|NCT00366301|B3|Baseline|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
664806|NCT00366301|B2|Baseline|Metformin Pill|Metformin pill
664807|NCT00366301|B1|Baseline|Placebo Pill|Placebo pill
664808|NCT00366301|P4|Participant Flow|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
664809|NCT00366301|P3|Participant Flow|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
664810|NCT00366301|P2|Participant Flow|Metformin Pill|Metformin pill
664811|NCT00366301|P1|Participant Flow|Placebo Pill|Placebo pill
664812|NCT00366301|O4|Outcome|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
664813|NCT00366301|O3|Outcome|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
664814|NCT00366301|O2|Outcome|Metformin Pill|Metformin pill
664815|NCT00366301|O1|Outcome|Placebo Pill|Placebo pill
664816|NCT00366301|E4|Reported Event|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
664817|NCT00366301|E3|Reported Event|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
664818|NCT00366301|E2|Reported Event|Metformin Pill|Metformin pill
664819|NCT00366301|E1|Reported Event|Placebo Pill|Placebo pill
664820|NCT00366275|B1|Baseline|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
664821|NCT00366275|P1|Participant Flow|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
664822|NCT00366275|O1|Outcome|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
664823|NCT00366275|E1|Reported Event|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
664824|NCT00366249|B3|Baseline|Total|Total of all reporting groups
664825|NCT00366249|B2|Baseline|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664826|NCT00366249|B1|Baseline|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664827|NCT00366249|P2|Participant Flow|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664828|NCT00366249|P1|Participant Flow|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664829|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664830|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664831|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664832|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664833|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664834|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664835|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664836|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664837|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664838|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664839|NCT00366249|E2|Reported Event|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
664840|NCT00366249|E1|Reported Event|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
664841|NCT00366106|B1|Baseline|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
664842|NCT00366106|P1|Participant Flow|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
664843|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
664844|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
664845|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
664846|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
664873|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664847|NCT00366106|E1|Reported Event|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
664848|NCT00366028|B3|Baseline|Total|Total of all reporting groups
664849|NCT00366028|B2|Baseline|Data Feedback|"Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Only Model: The research team will periodically interview the facilities and provide them with reported hand hygiene data."
664850|NCT00366028|B1|Baseline|Organizational Model|"Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
664851|NCT00366028|P2|Participant Flow|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
664852|NCT00366028|P1|Participant Flow|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two."
664853|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 9 study sites (medical centers) in total. Only 5 of the study sites are included in analysis of this outcome measure due to incomplete hand hygiene data at 4 of the study sites. Of the 5 study sites included, there were 2 sites with high fidelity to the Organization Model and 3 sites with low fidelity to the Organizational model, even though the model was not specifically introduced to the control arm."
664854|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 7 study sites (medical centers). Of the 7 sites there were 4 with high fidelity to the Organizational Model and 3 with low fidelity to the Organizational Model."
664855|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites."
664856|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 889 individual participants across 7 study sites (medical centers)."
664857|NCT00366028|E2|Reported Event|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
664858|NCT00366028|E1|Reported Event|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
664859|NCT00365976|B3|Baseline|Total|Total of all reporting groups
664860|NCT00365976|B2|Baseline|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664861|NCT00365976|B1|Baseline|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664862|NCT00365976|P2|Participant Flow|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664863|NCT00365976|P1|Participant Flow|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664864|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664865|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664866|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664867|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664868|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
676024|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
664875|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664876|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664877|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664878|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664879|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664880|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664881|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664882|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664883|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664884|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664885|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664886|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664887|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664888|NCT00365976|E2|Reported Event|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
664889|NCT00365976|E1|Reported Event|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
664890|NCT00365872|B4|Baseline|Total|Total of all reporting groups
664891|NCT00365872|B3|Baseline|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664892|NCT00365872|B2|Baseline|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664893|NCT00365872|B1|Baseline|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664894|NCT00365872|P3|Participant Flow|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664895|NCT00365872|P2|Participant Flow|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664896|NCT00365872|P1|Participant Flow|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664897|NCT00365872|O3|Outcome|Single Arm - Cohort 3|DC injection # 4 given 72 hours prior to surgery
664898|NCT00365872|O2|Outcome|Single Arm - Cohort 2|DC injection # 4 given 48 hours prior to surgery
664899|NCT00365872|O1|Outcome|Single Arm - Cohort 1|DC injection # 4 given 24 hours prior to surgery
664923|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664900|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664901|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664902|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664903|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664904|NCT00365872|E1|Reported Event|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
664905|NCT00365859|B4|Baseline|Total|Total of all reporting groups
664906|NCT00365859|B3|Baseline|Rollover Aripiprazole|As previously described in Participant Flow
664907|NCT00365859|B2|Baseline|Rollover Placebo|As previously described in Participant Flow
664908|NCT00365859|B1|Baseline|De Novo|As previously described in Participant Flow
664909|NCT00365859|P4|Participant Flow|Total|
664910|NCT00365859|P3|Participant Flow|Rollover Aripiprazole|Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
664911|NCT00365859|P2|Participant Flow|Rollover Placebo|Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
664912|NCT00365859|P1|Participant Flow|De Novo|De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
664913|NCT00365859|O4|Outcome|Total|
664914|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664915|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664916|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664917|NCT00365859|O4|Outcome|Total|
664918|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664919|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664924|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664925|NCT00365859|O4|Outcome|Total|
664926|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664927|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664928|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664929|NCT00365859|O4|Outcome|Total|
664930|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664931|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664932|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664933|NCT00365859|O4|Outcome|Total|
664934|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664935|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664936|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664937|NCT00365859|O4|Outcome|Total|
664938|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664939|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664940|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664941|NCT00365859|O4|Outcome|Total|
664942|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664943|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664944|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664945|NCT00365859|O4|Outcome|Total|
664946|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664947|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664948|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664949|NCT00365859|O4|Outcome|Total|
664950|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664951|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664952|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664953|NCT00365859|O4|Outcome|Total|
664954|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664955|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664956|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664957|NCT00365859|O4|Outcome|Total|
664958|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664959|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664960|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664961|NCT00365859|O4|Outcome|Total|
664962|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664963|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664964|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664965|NCT00365859|O4|Outcome|Total|
664966|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664967|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664968|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664969|NCT00365859|O4|Outcome|Total|
664970|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664971|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664972|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664973|NCT00365859|O4|Outcome|Total|
664974|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664975|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664976|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664977|NCT00365859|O4|Outcome|Total|
664978|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664979|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664980|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664981|NCT00365859|O4|Outcome|Total|
664982|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664983|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664984|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664985|NCT00365859|O4|Outcome|Total|
664986|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664987|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664988|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664989|NCT00365859|O4|Outcome|Total|
664990|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664991|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664992|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664993|NCT00365859|O4|Outcome|Total|
664994|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
664995|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
664996|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
664997|NCT00365859|E3|Reported Event|Roll Over Placebo|
664998|NCT00365859|E2|Reported Event|Roll Over Aripiprazole|
664999|NCT00365859|E1|Reported Event|De Novo|
665000|NCT00365846|B1|Baseline|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
665001|NCT00365846|P1|Participant Flow|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
665002|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
665003|NCT00365846|O1|Outcome|Group 1Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction w/ Sirolimus immunosuppression
665004|NCT00365846|O1|Outcome|Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction on Day -1 and 0 of renal transplant followed w/ Sirolimus maintenance immunosuppression
665005|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
665006|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
665007|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
665008|NCT00365846|E1|Reported Event|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
665009|NCT00365768|B3|Baseline|Total|Total of all reporting groups
665010|NCT00365768|B2|Baseline|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
665011|NCT00365768|B1|Baseline|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
665012|NCT00365768|P2|Participant Flow|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
665013|NCT00365768|P1|Participant Flow|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
665014|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
665015|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
665016|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
665017|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
665018|NCT00365768|E2|Reported Event|Arm II|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
665019|NCT00365768|E1|Reported Event|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
665020|NCT00365716|B6|Baseline|Total|Total of all reporting groups
665021|NCT00365716|B5|Baseline|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665022|NCT00365716|B4|Baseline|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665023|NCT00365716|B3|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665024|NCT00365716|B2|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665025|NCT00365716|B1|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665026|NCT00365716|P7|Participant Flow|Extension 2|This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
665027|NCT00365716|P6|Participant Flow|Extension 1|This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
665063|NCT00365508|P2|Participant Flow|Nicotine Lozenge|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
665327|NCT00364858|B1|Baseline|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
665028|NCT00365716|P5|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665029|NCT00365716|P4|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665030|NCT00365716|P3|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665031|NCT00365716|P2|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665032|NCT00365716|P1|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665033|NCT00365716|O2|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225 or 450 Combined|For the purposes of this outcome measure, the placebo groups (225 mcg and 450 mcg) were combined.
665034|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665035|NCT00365716|O5|Outcome|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665036|NCT00365716|O4|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665037|NCT00365716|O3|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665038|NCT00365716|O2|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665039|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665040|NCT00365716|E6|Reported Event|Extensions|"This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.~Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table."
665041|NCT00365716|E5|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665042|NCT00365716|E4|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665043|NCT00365716|E3|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
665044|NCT00365716|E2|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table."
665045|NCT00365716|E1|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.~There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table."
665046|NCT00365599|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
665047|NCT00365599|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
665048|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
665049|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
665050|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
665051|NCT00365599|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
665052|NCT00365547|B1|Baseline|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
665053|NCT00365547|P1|Participant Flow|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
665054|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
665055|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
665056|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
665057|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Only patients that remained in the study for at least 2 months and had the tumor measurements necessary to meet RECIST criteria are included.
665058|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab) given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
665059|NCT00365547|E1|Reported Event|Safety Population|Patients who received treatment with weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
665060|NCT00365508|B3|Baseline|Total|Total of all reporting groups
665061|NCT00365508|B2|Baseline|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
665062|NCT00365508|B1|Baseline|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
665064|NCT00365508|P1|Participant Flow|Nicotine Patch|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
665065|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
665066|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
665067|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
665068|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
665069|NCT00365508|E2|Reported Event|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
665070|NCT00365508|E1|Reported Event|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
665071|NCT00365456|B1|Baseline|PTH(1-84) or Risedronate|"PTH(1-84) received by 405 participants in Trial Period I~of those 405 participants, 282 received Risedronate in Trial Period II~of those 282 participants, 268 participant remained and 136 received PTH(1-84) and 132 received Risedronate in Trial Period III"
665072|NCT00365456|P2|Participant Flow|Risedronate|
665073|NCT00365456|P1|Participant Flow|PTH (1-84)|
665074|NCT00365456|O2|Outcome|Risedronate|Regimen 2 = PTH (1-84) → Risedronate → Risedronate
665075|NCT00365456|O1|Outcome|PTH (1-84)|Regimen 1 = PTH (1-84) → Risedronate → PTH (1-84)
665076|NCT00365456|E2|Reported Event|Risedronate|Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
665077|NCT00365456|E1|Reported Event|PTH (1-84)|Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
665078|NCT00365417|B1|Baseline|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
665079|NCT00365417|P1|Participant Flow|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
665080|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
665081|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
665082|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
665083|NCT00365417|E1|Reported Event|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
665084|NCT00365391|B1|Baseline|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665085|NCT00365391|P1|Participant Flow|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine epidermal growth factor receptor (EGFR) and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by immuno-histochemistry (IHC) for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, mitogen-activated protein kinase (MAPK), and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665086|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665100|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
665324|NCT00364923|E1|Reported Event|Full Population|All patients who received at least one dose of pralatrexate
665087|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665088|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665089|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665090|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665091|NCT00365391|E1|Reported Event|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
665092|NCT00365378|B3|Baseline|Total|Total of all reporting groups
665093|NCT00365378|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
665094|NCT00365378|B1|Baseline|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
665095|NCT00365378|P3|Participant Flow|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
665096|NCT00365378|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
665097|NCT00365378|P1|Participant Flow|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
665098|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
665099|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
665186|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665101|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
665102|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
665103|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
665104|NCT00365378|E3|Reported Event|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
665105|NCT00365378|E2|Reported Event|Placebo (Group 2)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
665106|NCT00365378|E1|Reported Event|HPV 16 L1 VLP (Group 1)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
665107|NCT00365365|B4|Baseline|Total|Total of all reporting groups
665108|NCT00365365|B3|Baseline|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665109|NCT00365365|B2|Baseline|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665110|NCT00365365|B1|Baseline|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665111|NCT00365365|P3|Participant Flow|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665112|NCT00365365|P2|Participant Flow|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665113|NCT00365365|P1|Participant Flow|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665114|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665115|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665116|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665117|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665118|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665240|NCT00365261|E2|Reported Event|Placebo|receipt of placebo
665241|NCT00365261|E1|Reported Event|Eszopiclone|receipt of active drug
665325|NCT00364858|B3|Baseline|Total|Total of all reporting groups
676025|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
665119|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665120|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665121|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665122|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665123|NCT00365365|E3|Reported Event|TCH + Bevacizumab|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665124|NCT00365365|E2|Reported Event|TAC + Bevacizumab|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665125|NCT00365365|E1|Reported Event|AC->T + Bevacizumab|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
665126|NCT00365352|B4|Baseline|Total|Total of all reporting groups
665127|NCT00365352|B3|Baseline|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665128|NCT00365352|B2|Baseline|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665129|NCT00365352|B1|Baseline|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665130|NCT00365352|P3|Participant Flow|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665131|NCT00365352|P2|Participant Flow|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665132|NCT00365352|P1|Participant Flow|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665133|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665134|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665135|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665136|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665137|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665138|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665139|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665140|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665141|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
676026|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
665142|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665143|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665144|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665145|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665146|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665147|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665148|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665149|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665150|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665151|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665152|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665153|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665154|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665155|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665156|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665157|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665158|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665159|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665160|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665161|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665162|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665163|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665275|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
665164|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665165|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665166|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665167|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665168|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665169|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665170|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665171|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665172|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665173|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665174|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665175|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665176|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665177|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665178|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665179|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665180|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665181|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665182|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665183|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665184|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665185|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665326|NCT00364858|B2|Baseline|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
676027|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
665187|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665188|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665189|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665190|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665191|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665192|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665193|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665194|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665195|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665196|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665197|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665198|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665199|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665200|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665201|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665202|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665203|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665204|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665205|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665206|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665207|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665208|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665209|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
676028|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
665210|NCT00365352|E3|Reported Event|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
665211|NCT00365352|E2|Reported Event|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665212|NCT00365352|E1|Reported Event|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
665213|NCT00365300|B3|Baseline|Total|Total of all reporting groups
665214|NCT00365300|B2|Baseline|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
665215|NCT00365300|B1|Baseline|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
665216|NCT00365300|P2|Participant Flow|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
665217|NCT00365300|P1|Participant Flow|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
665218|NCT00365300|O2|Outcome|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
665219|NCT00365300|O1|Outcome|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
665220|NCT00365300|E5|Reported Event|Follow-up|
665221|NCT00365300|E4|Reported Event|Placebo (Double-blind Phase)|
665222|NCT00365300|E3|Reported Event|Pantoprazole Sodium Granules (Double-blind Phase)|
665223|NCT00365300|E2|Reported Event|Pantoprazole Sodium Granules (Open-Label Phase)|
665224|NCT00365300|E1|Reported Event|Screening|
665225|NCT00365274|B1|Baseline|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
665226|NCT00365274|P1|Participant Flow|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
665227|NCT00365274|O1|Outcome|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
665228|NCT00365274|E1|Reported Event|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
665229|NCT00365261|B3|Baseline|Total|Total of all reporting groups
665230|NCT00365261|B2|Baseline|Placebo|receipt of placebo
665231|NCT00365261|B1|Baseline|Eszopiclone|receipt of active drug
665232|NCT00365261|P2|Participant Flow|Placebo|receipt of placebo
665233|NCT00365261|P1|Participant Flow|Eszopiclone|receipt of active drug
665234|NCT00365261|O2|Outcome|Placebo|placebo
665235|NCT00365261|O1|Outcome|Eszopiclone|active drug
665236|NCT00365261|O2|Outcome|Placebo|"placebo~Placebo: placebo 2 to 3 mg po at bedtime"
665237|NCT00365261|O1|Outcome|Eszopiclone|"active drug~Eszopiclone: eszopiclone 2 to 3 mg po at bedtime"
665238|NCT00365261|O2|Outcome|Placebo|placebo
665239|NCT00365261|O1|Outcome|Eszopiclone|active drug
665242|NCT00365209|B1|Baseline|Curcumin|"Stage 1: Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665243|NCT00365209|P1|Participant Flow|Curcumin|"Stage 1: Particpants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Particpants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665244|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665245|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665246|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665247|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665248|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665249|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665250|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665251|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665252|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665253|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665254|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665255|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665256|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665276|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
665257|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665258|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665259|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665260|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665261|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665262|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665263|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665264|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665265|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665266|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665267|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665268|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665269|NCT00365209|E2|Reported Event|Stage2 4 g Curcumin|"Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665270|NCT00365209|E1|Reported Event|Stage1 2 g Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
665271|NCT00365144|B1|Baseline|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
665272|NCT00365144|P1|Participant Flow|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
665273|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib Hydrochloride|"A treatment cycle is 21 days:~bevacizumab 15 mg/kg as a 60–90 min infusion once every 21 days, with erlotinib hydrochloride 150 mg by mouth daily~bevacizumab~erlotinib hydrochloride~laboratory biomarker analysis"
665274|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
665277|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
665278|NCT00365144|E1|Reported Event|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
665279|NCT00365105|B3|Baseline|Total|Total of all reporting groups
665280|NCT00365105|B2|Baseline|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
665281|NCT00365105|B1|Baseline|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
665282|NCT00365105|P2|Participant Flow|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
665283|NCT00365105|P1|Participant Flow|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
665284|NCT00365105|O2|Outcome|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
665285|NCT00365105|O1|Outcome|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
665286|NCT00365105|E2|Reported Event|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
665287|NCT00365105|E1|Reported Event|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
665288|NCT00365053|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665289|NCT00365053|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665290|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665291|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665292|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665293|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665294|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665295|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665296|NCT00365053|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
665297|NCT00364949|B3|Baseline|Total|Total of all reporting groups
665298|NCT00364949|B2|Baseline|PCOS|Polycystic Ovary Syndrome
665299|NCT00364949|B1|Baseline|Control|Control
665300|NCT00364949|P2|Participant Flow|PCOS|Polycystic Ovary Syndrome
665301|NCT00364949|P1|Participant Flow|Control|Control
665302|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
665303|NCT00364949|O1|Outcome|Control|Control
665304|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
665305|NCT00364949|O1|Outcome|Control|Control
665306|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
665307|NCT00364949|O1|Outcome|Control|Control
665308|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
665309|NCT00364949|O1|Outcome|Control|Control
665310|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
665311|NCT00364949|O1|Outcome|Control|Control
665312|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
665313|NCT00364949|O1|Outcome|Control|Control
665314|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
665315|NCT00364949|O1|Outcome|Control|Control
665316|NCT00364949|E2|Reported Event|PCOS|Polycystic Ovary Syndrome
665317|NCT00364949|E1|Reported Event|Control|Control
665318|NCT00364923|B1|Baseline|Full Population|All patients who received at least one dose of pralatrexate
665319|NCT00364923|P1|Participant Flow|Full Population|All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
665320|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
665321|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
665322|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
665323|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
665328|NCT00364858|P2|Participant Flow|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
665329|NCT00364858|P1|Participant Flow|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
665330|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
665331|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
665332|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
665333|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
665334|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
665335|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
665336|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
665337|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
665338|NCT00364858|E3|Reported Event|Total|
665339|NCT00364858|E2|Reported Event|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
665340|NCT00364858|E1|Reported Event|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
665341|NCT00364845|B3|Baseline|Total|Total of all reporting groups
665342|NCT00364845|B2|Baseline|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
665343|NCT00364845|B1|Baseline|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
665344|NCT00364845|P2|Participant Flow|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
665345|NCT00364845|P1|Participant Flow|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
665346|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
665347|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
665348|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
665349|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
665350|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
665351|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
665352|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
665353|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
665354|NCT00364845|E2|Reported Event|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
665355|NCT00364845|E1|Reported Event|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
665356|NCT00364832|B10|Baseline|Total|Total of all reporting groups
665357|NCT00364832|B9|Baseline|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665358|NCT00364832|B8|Baseline|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665359|NCT00364832|B7|Baseline|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665360|NCT00364832|B6|Baseline|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665361|NCT00364832|B5|Baseline|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665362|NCT00364832|B4|Baseline|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
676029|NCT00330460|E2|Reported Event|Denosumab 60 mg Q6M|
665363|NCT00364832|B3|Baseline|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665364|NCT00364832|B2|Baseline|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665365|NCT00364832|B1|Baseline|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665366|NCT00364832|P12|Participant Flow|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered SC RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665367|NCT00364832|P11|Participant Flow|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered SC RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665368|NCT00364832|P10|Participant Flow|RO0503821 (1x/ Week)|Eligible participants were administered SC RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kilogram of the previous weekly ESA dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665369|NCT00364832|P9|Participant Flow|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665370|NCT00364832|P8|Participant Flow|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665371|NCT00364832|P7|Participant Flow|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665372|NCT00364832|P6|Participant Flow|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665373|NCT00364832|P5|Participant Flow|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665374|NCT00364832|P4|Participant Flow|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665375|NCT00364832|P3|Participant Flow|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665376|NCT00364832|P2|Participant Flow|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665377|NCT00364832|P1|Participant Flow|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneous (SC) using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665378|NCT00364832|O3|Outcome|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665605|NCT00364533|P5|Participant Flow|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
665379|NCT00364832|O2|Outcome|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665380|NCT00364832|O1|Outcome|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665381|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665382|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665383|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665384|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665385|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665386|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665387|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665388|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665389|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665390|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665391|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665392|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665393|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665394|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665395|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665434|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
676030|NCT00330460|E1|Reported Event|Alendronate 70 mg QW|
665396|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665397|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665398|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665399|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665400|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665401|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665402|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665403|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665404|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665405|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665406|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665407|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665408|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665409|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665410|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665411|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665412|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665413|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665435|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
679770|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
665414|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665415|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665416|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665417|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665418|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665419|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665420|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665421|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665422|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665423|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665424|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665425|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665426|NCT00364832|E3|Reported Event|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665427|NCT00364832|E2|Reported Event|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665428|NCT00364832|E1|Reported Event|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
665429|NCT00364819|B1|Baseline|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
665430|NCT00364819|P1|Participant Flow|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
665431|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
665432|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
665433|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
665436|NCT00364819|E1|Reported Event|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
665437|NCT00364793|B5|Baseline|Total|Total of all reporting groups
665438|NCT00364793|B4|Baseline|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665439|NCT00364793|B3|Baseline|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665440|NCT00364793|B2|Baseline|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665441|NCT00364793|B1|Baseline|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665442|NCT00364793|P4|Participant Flow|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665443|NCT00364793|P3|Participant Flow|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665444|NCT00364793|P2|Participant Flow|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665445|NCT00364793|P1|Participant Flow|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665446|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665447|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665448|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665449|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665450|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665451|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665452|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665453|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665454|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665455|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665456|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665457|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665458|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665980|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400/100mg once a day (QD)
665459|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665460|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665461|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665462|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665463|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665464|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665465|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665466|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665467|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665468|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665469|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665981|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665470|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665471|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665472|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665473|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665474|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665475|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665476|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665477|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665478|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665597|NCT00364611|E2|Reported Event|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
679780|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
665479|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665480|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665481|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665482|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665483|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665484|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665485|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665486|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665487|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665606|NCT00364533|P4|Participant Flow|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
680071|NCT00323635|B1|Baseline|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
665488|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665489|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665490|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665491|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665492|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665493|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665494|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665495|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665496|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665497|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665598|NCT00364611|E1|Reported Event|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665498|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665499|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665500|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665501|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665502|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665503|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665504|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665505|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665506|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665507|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665508|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665599|NCT00364533|B6|Baseline|Total|Total of all reporting groups
665509|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665510|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665511|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665512|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665513|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665514|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665515|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665516|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665517|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665518|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665519|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665982|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665520|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665521|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665522|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665523|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665524|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665525|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665526|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665527|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665528|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665529|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665530|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665600|NCT00364533|B5|Baseline|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
680079|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
665531|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665532|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665533|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665534|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665535|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665536|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665537|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665538|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665539|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665540|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665541|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665601|NCT00364533|B4|Baseline|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
680273|NCT00323414|O1|Outcome|PUFA|Active treatment with PUFA
665542|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665543|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665544|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665545|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665546|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665547|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665548|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665549|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665550|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665551|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665552|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665983|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665553|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665554|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665555|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665556|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665557|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665558|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665559|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665560|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665561|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665562|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665563|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665564|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665565|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665566|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665567|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665568|NCT00364793|O5|Outcome|Total Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
665569|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665570|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665571|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665572|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665573|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665574|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665575|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665602|NCT00364533|B3|Baseline|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665576|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665577|NCT00364793|E1|Reported Event|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
665578|NCT00364611|B3|Baseline|Total|Total of all reporting groups
665579|NCT00364611|B2|Baseline|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665580|NCT00364611|B1|Baseline|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665581|NCT00364611|P2|Participant Flow|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665582|NCT00364611|P1|Participant Flow|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665583|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665584|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665585|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665586|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665587|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665588|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665589|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665590|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665591|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665592|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665593|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665594|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665595|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665596|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
665603|NCT00364533|B2|Baseline|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665604|NCT00364533|B1|Baseline|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665607|NCT00364533|P3|Participant Flow|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665608|NCT00364533|P2|Participant Flow|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665609|NCT00364533|P1|Participant Flow|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665610|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
665611|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
665612|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665613|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665614|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665615|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
665616|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
665617|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665618|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665619|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665620|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
665621|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
665622|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665623|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665624|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665625|NCT00364533|E5|Reported Event|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
665626|NCT00364533|E4|Reported Event|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
665627|NCT00364533|E3|Reported Event|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665628|NCT00364533|E2|Reported Event|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665629|NCT00364533|E1|Reported Event|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
665630|NCT00364377|B3|Baseline|Total|Total of all reporting groups
665631|NCT00364377|B2|Baseline|Placebo|People with impaired fasting glucose treated with placebo once daily.
665632|NCT00364377|B1|Baseline|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
665633|NCT00364377|P2|Participant Flow|Placebo|People with impaired fasting glucose treated with placebo once daily.
665634|NCT00364377|P1|Participant Flow|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
665635|NCT00364377|O2|Outcome|Placebo|People with impaired fasting glucose treated with placebo once daily.
665636|NCT00364377|O1|Outcome|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
665637|NCT00364377|E2|Reported Event|Placebo|People with impaired fasting glucose treated with placebo once daily.
665638|NCT00364377|E1|Reported Event|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
665639|NCT00364351|B3|Baseline|Total|Total of all reporting groups
665640|NCT00364351|B2|Baseline|Erlotinib|Erlotinib
665641|NCT00364351|B1|Baseline|Vandetanib|Vandetanib 300 mg
665642|NCT00364351|P2|Participant Flow|Erlotinib|Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib
665643|NCT00364351|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib
665644|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
665645|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
665646|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
665647|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
665648|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
665649|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
665650|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
665651|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
665652|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
665653|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
665654|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
665655|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
665656|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
665657|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
665658|NCT00364351|E2|Reported Event|Erlotinib|Erlotinib.
665659|NCT00364351|E1|Reported Event|Vandetanib|Vandetanib 300 mg.
665660|NCT00364286|B1|Baseline|Dasatinib|Dasatinib 50mg Orally twice daily.
665661|NCT00364286|P1|Participant Flow|Dasatinib|Dasatinib 50mg Orally twice daily.
665662|NCT00364286|O1|Outcome|Dasatinib|Dasatinib 50mg Orally twice daily.
665663|NCT00364286|E1|Reported Event|Dasatinib|Dasatinib 50mg Orally twice daily.
665664|NCT00364182|B4|Baseline|Total|Total of all reporting groups
665665|NCT00364182|B3|Baseline|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
665666|NCT00364182|B2|Baseline|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
665667|NCT00364182|B1|Baseline|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
680274|NCT00323414|O2|Outcome|Placebo|Placebo arm of therapy
665668|NCT00364182|P3|Participant Flow|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
665669|NCT00364182|P2|Participant Flow|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
665670|NCT00364182|P1|Participant Flow|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
665671|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665672|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665673|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
665674|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
665675|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665676|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665677|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
665678|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
665679|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665680|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665681|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
665682|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
665683|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665684|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665685|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
665686|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
665687|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665688|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665689|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
665690|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
665691|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665692|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665693|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
665694|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665695|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665696|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
665697|NCT00364182|E4|Reported Event|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
665698|NCT00364182|E3|Reported Event|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
665699|NCT00364182|E2|Reported Event|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
665700|NCT00364182|E1|Reported Event|BeneFIX OD1|BeneFIX in an on-demand IV bolus infusion for 16 weeks (first intervention)
665701|NCT00364156|B3|Baseline|Total|Total of all reporting groups
665702|NCT00364156|B2|Baseline|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
665703|NCT00364156|B1|Baseline|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
665704|NCT00364156|P2|Participant Flow|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
665705|NCT00364156|P1|Participant Flow|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
665706|NCT00364156|O2|Outcome|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
665707|NCT00364156|O1|Outcome|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
665708|NCT00364156|E2|Reported Event|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
665709|NCT00364156|E1|Reported Event|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
665710|NCT00364130|B3|Baseline|Total|Total of all reporting groups
665711|NCT00364130|B2|Baseline|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665712|NCT00364130|B1|Baseline|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665713|NCT00364130|P2|Participant Flow|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665714|NCT00364130|P1|Participant Flow|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665715|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665716|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665717|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665718|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665719|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665720|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665721|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665722|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665723|NCT00364130|O2|Outcome|Inactive Low Magnitude Mechanical Stimulus|"Inactive, or placebo low magnitude mechanical stimulus~Placebo (inactive) low magnitude mechanical stimulus: 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device"
665724|NCT00364130|O1|Outcome|Active Low Magnitude Mechanical Stimulus|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus: 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665725|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665726|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665727|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665728|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665729|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665730|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665731|NCT00364130|E2|Reported Event|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
665732|NCT00364130|E1|Reported Event|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
665733|NCT00364013|B3|Baseline|Total|Total of all reporting groups
665734|NCT00364013|B2|Baseline|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665735|NCT00364013|B1|Baseline|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665736|NCT00364013|P2|Participant Flow|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665737|NCT00364013|P1|Participant Flow|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665738|NCT00364013|O2|Outcome|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665739|NCT00364013|O1|Outcome|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665740|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665741|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665742|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665743|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665744|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665745|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665746|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665747|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665787|NCT00363805|P3|Participant Flow|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
665748|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665749|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665750|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665751|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665752|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665753|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665754|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665755|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665756|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665757|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665758|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665759|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665760|NCT00364013|E2|Reported Event|FOLFOX Alone|Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
665761|NCT00364013|E1|Reported Event|Panitumumab Plus FOLFOX|Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
665762|NCT00363896|B3|Baseline|Total|Total of all reporting groups
665763|NCT00363896|B2|Baseline|Placebo|Placebo by inhalation
665764|NCT00363896|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
665765|NCT00363896|P2|Participant Flow|Placebo|Placebo by inhalation
665766|NCT00363896|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
665767|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
665768|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
665769|NCT00363896|O2|Outcome|Placebo|Placebo by inhalation
665770|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
665771|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
665772|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
665773|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
665774|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
665775|NCT00363896|E2|Reported Event|Placebo|Placebo by inhalation
665776|NCT00363896|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
665777|NCT00363883|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
665778|NCT00363883|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
665779|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
665780|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
665781|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
665782|NCT00363883|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
665783|NCT00363805|B4|Baseline|Total|Total of all reporting groups
665784|NCT00363805|B3|Baseline|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
665785|NCT00363805|B2|Baseline|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
665786|NCT00363805|B1|Baseline|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
665788|NCT00363805|P2|Participant Flow|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
665789|NCT00363805|P1|Participant Flow|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
665790|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
665791|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
665792|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
665793|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
665794|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
665795|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
665796|NCT00363805|E3|Reported Event|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
665797|NCT00363805|E2|Reported Event|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
665798|NCT00363805|E1|Reported Event|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
665799|NCT00363779|B1|Baseline|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
665800|NCT00363779|P1|Participant Flow|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
665801|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
665802|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
665803|NCT00363779|E1|Reported Event|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
665804|NCT00363675|B1|Baseline|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
665805|NCT00363675|P1|Participant Flow|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
665806|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
665807|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
665808|NCT00363675|O1|Outcome|Normal as Defined by Hand Therapist.|Children were administered hand assessments to measure function after hand burns by a trained therapist.
665809|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
665810|NCT00363675|E1|Reported Event|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
665811|NCT00363545|B3|Baseline|Total|Total of all reporting groups
665812|NCT00363545|B2|Baseline|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665813|NCT00363545|B1|Baseline|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665814|NCT00363545|P2|Participant Flow|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665815|NCT00363545|P1|Participant Flow|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665816|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665817|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665818|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665819|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665820|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665821|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665884|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665822|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665823|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665824|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665825|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665826|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665827|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665828|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665829|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665830|NCT00363545|E2|Reported Event|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665831|NCT00363545|E1|Reported Event|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
665832|NCT00363480|B1|Baseline|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665833|NCT00363480|P1|Participant Flow|SFC 50/250 mcg|Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665834|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665835|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665836|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665837|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665838|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665885|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665886|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665839|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665840|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665841|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665842|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665843|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665844|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665845|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665846|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665847|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665848|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665849|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665887|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665888|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665889|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665850|NCT00363480|O1|Outcome|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665851|NCT00363480|E1|Reported Event|SFC 50/250 mcg|Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant’s asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
665852|NCT00363467|B1|Baseline|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665853|NCT00363467|P1|Participant Flow|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665854|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665855|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665856|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665857|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665858|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665859|NCT00363467|E1|Reported Event|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
665860|NCT00363415|B3|Baseline|Total|Total of all reporting groups
665861|NCT00363415|B2|Baseline|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665862|NCT00363415|B1|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665863|NCT00363415|P2|Participant Flow|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665864|NCT00363415|P1|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665865|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665866|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665867|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665868|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665869|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665870|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665871|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665872|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665873|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665874|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665875|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665876|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
665877|NCT00363415|E2|Reported Event|Etoposide + Carboplatin|"Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.~(Participants who received at least one dose of study drug)"
665878|NCT00363415|E1|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)
665879|NCT00363311|B3|Baseline|Total|Total of all reporting groups
665880|NCT00363311|B2|Baseline|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665881|NCT00363311|B1|Baseline|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665882|NCT00363311|P2|Participant Flow|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665883|NCT00363311|P1|Participant Flow|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
665890|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665891|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665892|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665893|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665894|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665895|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665896|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665897|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665898|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665899|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665900|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665901|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665902|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665903|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665904|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665905|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665906|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665907|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665908|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665909|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665910|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665911|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665912|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665913|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665914|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665915|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665916|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665917|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665918|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665919|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665920|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665921|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665922|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665923|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665924|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665925|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665926|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665927|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665928|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665929|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665930|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665931|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665932|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665933|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665934|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665935|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665936|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665937|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665938|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665939|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665940|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665941|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665942|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665943|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665944|NCT00363311|E2|Reported Event|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
665945|NCT00363311|E1|Reported Event|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
665946|NCT00363298|B3|Baseline|Total|Total of all reporting groups
665947|NCT00363298|B2|Baseline|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
665948|NCT00363298|B1|Baseline|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
665949|NCT00363298|P2|Participant Flow|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
665950|NCT00363298|P1|Participant Flow|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
665951|NCT00363298|O2|Outcome|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
665952|NCT00363298|O1|Outcome|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
665953|NCT00363298|O2|Outcome|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
665954|NCT00363298|O1|Outcome|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
665955|NCT00363298|E2|Reported Event|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
665956|NCT00363298|E1|Reported Event|D-amphetamine|Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
665957|NCT00363246|B1|Baseline|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
665958|NCT00363246|P1|Participant Flow|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
665959|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older Veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
665960|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
665961|NCT00363246|E1|Reported Event|Elderly Veterans Using Wheelchairs for Mobility|Older veterans who use a wheelchair for their primary means of mobility. This was an observational study. There was no intervention and thus no adverse events were collected as part of the study. Sometimes we learned of a death from a relative when we called monthly.
665962|NCT00363168|B3|Baseline|Total|Total of all reporting groups
665963|NCT00363168|B2|Baseline|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
665964|NCT00363168|B1|Baseline|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
665965|NCT00363168|P2|Participant Flow|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
665966|NCT00363168|P1|Participant Flow|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
665967|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
665968|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
665969|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
665970|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
665971|NCT00363168|E2|Reported Event|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
665972|NCT00363168|E1|Reported Event|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
665973|NCT00363142|B3|Baseline|Total|Total of all reporting groups
665974|NCT00363142|B2|Baseline|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665975|NCT00363142|B1|Baseline|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665976|NCT00363142|P2|Participant Flow|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665977|NCT00363142|P1|Participant Flow|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665978|NCT00363142|O3|Outcome|FPV/RTV 700/100 mg BID|Twice daily FPV regimen boosted with a reduced dose of RTV 100 mg
665979|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700/100mg twice a day [BID] or 1400/200mg QD)
665984|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665985|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665986|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665987|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665988|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665989|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665990|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665991|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665992|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665993|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665994|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665995|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665996|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665997|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
665998|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
665999|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
666000|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
666001|NCT00363142|E2|Reported Event|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
666002|NCT00363142|E1|Reported Event|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
666003|NCT00363129|B3|Baseline|Total|Total of all reporting groups
666004|NCT00363129|B2|Baseline|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666005|NCT00363129|B1|Baseline|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666006|NCT00363129|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666007|NCT00363129|P1|Participant Flow|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666008|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666009|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666010|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666011|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666012|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666013|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666014|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666015|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666016|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666017|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666018|NCT00363129|E2|Reported Event|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666019|NCT00363129|E1|Reported Event|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
666020|NCT00363077|B3|Baseline|Total|Total of all reporting groups
666021|NCT00363077|B2|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666022|NCT00363077|B1|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666023|NCT00363077|P2|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666024|NCT00363077|P1|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666025|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666599|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666026|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666027|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666028|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666029|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666030|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666031|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666032|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666033|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666034|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666035|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666036|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666037|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666038|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666039|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666040|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666041|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666042|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666043|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666044|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666045|NCT00363077|E2|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666046|NCT00363077|E1|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
666047|NCT00363051|B3|Baseline|Total|Total of all reporting groups
666048|NCT00363051|B2|Baseline|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
666049|NCT00363051|B1|Baseline|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666050|NCT00363051|P2|Participant Flow|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
666051|NCT00363051|P1|Participant Flow|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666113|NCT00362648|E5|Reported Event|RotaTeq™ - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
666052|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
666053|NCT00363051|O2|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
666054|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666055|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
666056|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666057|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
666058|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666059|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
666060|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666061|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
666062|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
666063|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666064|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666065|NCT00363051|E2|Reported Event|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
666066|NCT00363051|E1|Reported Event|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
666067|NCT00363038|B1|Baseline|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
666068|NCT00363038|P1|Participant Flow|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum United States Pharmacopeia (USP) as placebo.
666162|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
680275|NCT00323414|O1|Outcome|PUFA|Active treatment with PUFA
666069|NCT00363038|O1|Outcome|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
666070|NCT00363038|E1|Reported Event|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
666071|NCT00362882|B3|Baseline|Total|Total of all reporting groups
666072|NCT00362882|B2|Baseline|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666073|NCT00362882|B1|Baseline|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666074|NCT00362882|P2|Participant Flow|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666075|NCT00362882|P1|Participant Flow|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666076|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666077|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666078|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666079|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666080|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666081|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666082|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666083|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666084|NCT00362882|E2|Reported Event|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666085|NCT00362882|E1|Reported Event|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
666086|NCT00362817|B1|Baseline|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666087|NCT00362817|P1|Participant Flow|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666088|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666420|NCT00362115|P2|Participant Flow|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666089|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666090|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666091|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~carboplatin: IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.~temozolomide: 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks."
666092|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666093|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666094|NCT00362817|E1|Reported Event|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
666095|NCT00362648|B5|Baseline|Total|Total of all reporting groups
666096|NCT00362648|B4|Baseline|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666097|NCT00362648|B3|Baseline|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666098|NCT00362648|B2|Baseline|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666099|NCT00362648|B1|Baseline|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666100|NCT00362648|P4|Participant Flow|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666101|NCT00362648|P3|Participant Flow|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666102|NCT00362648|P2|Participant Flow|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666103|NCT00362648|P1|Participant Flow|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666104|NCT00362648|O2|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666105|NCT00362648|O1|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666106|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666107|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666108|NCT00362648|O4|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666109|NCT00362648|O3|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666110|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666111|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
666112|NCT00362648|E6|Reported Event|Placebo - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
666598|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666114|NCT00362648|E4|Reported Event|Placebo, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
666115|NCT00362648|E3|Reported Event|RotaTeq™, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
666116|NCT00362648|E2|Reported Event|Placebo|"Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
666117|NCT00362648|E1|Reported Event|RotaTeq™|"Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
666118|NCT00362609|B3|Baseline|Total|Total of all reporting groups
666119|NCT00362609|B2|Baseline|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
666120|NCT00362609|B1|Baseline|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
666121|NCT00362609|P2|Participant Flow|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
666122|NCT00362609|P1|Participant Flow|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
666123|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
666124|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
666125|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
666126|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
666127|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
666128|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
666129|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
666130|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
666131|NCT00362609|E2|Reported Event|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
666132|NCT00362609|E1|Reported Event|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
666133|NCT00362466|B3|Baseline|Total|Total of all reporting groups
666134|NCT00362466|B2|Baseline|Imatinib|600 mg QD
666135|NCT00362466|B1|Baseline|Dasatinib|100 mg QD
666136|NCT00362466|P2|Participant Flow|Imatinib|600 mg QD
666137|NCT00362466|P1|Participant Flow|Dasatinib|100 mg once daily (QD)
666138|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666139|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666140|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666141|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666142|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666143|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666144|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666145|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666146|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666147|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666148|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666149|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666150|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666151|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666152|NCT00362466|O2|Outcome|Imatinib|600 mg QD
666153|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
666154|NCT00362466|E2|Reported Event|Imatinib|600 mg QD
666155|NCT00362466|E1|Reported Event|Dasatinib|100 mg once daily (QD)
666156|NCT00362453|B3|Baseline|Total|Total of all reporting groups
666157|NCT00362453|B2|Baseline|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666158|NCT00362453|B1|Baseline|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666159|NCT00362453|P2|Participant Flow|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666160|NCT00362453|P1|Participant Flow|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666161|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666163|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666164|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666165|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666166|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666167|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666168|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666169|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666170|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666171|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666172|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666173|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666174|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666175|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666176|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666177|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666178|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666179|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666180|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666181|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666182|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666183|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666184|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666185|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666186|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666187|NCT00362453|E2|Reported Event|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
666188|NCT00362453|E1|Reported Event|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
666189|NCT00362440|B3|Baseline|Total|Total of all reporting groups
666190|NCT00362440|B2|Baseline|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
666191|NCT00362440|B1|Baseline|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
666192|NCT00362440|P2|Participant Flow|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
666193|NCT00362440|P1|Participant Flow|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
666194|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
666195|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
666196|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
666197|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
666198|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
666199|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
666200|NCT00362440|E2|Reported Event|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
666201|NCT00362440|E1|Reported Event|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
680276|NCT00323414|O2|Outcome|Placebo|Placebo arm of therapy
666202|NCT00362414|B1|Baseline|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
666203|NCT00362414|P1|Participant Flow|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
666204|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666205|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666206|NCT00362414|O1|Outcome|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
666207|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666208|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666209|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666210|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666211|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666212|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666213|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666214|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
666215|NCT00362414|O1|Outcome|Two Growth Factors|double growth factors
666216|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.~Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
666217|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.~Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
666218|NCT00362414|E1|Reported Event|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
666219|NCT00362401|B4|Baseline|Total|Total of all reporting groups
666220|NCT00362401|B3|Baseline|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666221|NCT00362401|B2|Baseline|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666222|NCT00362401|B1|Baseline|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666223|NCT00362401|P3|Participant Flow|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666224|NCT00362401|P2|Participant Flow|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666225|NCT00362401|P1|Participant Flow|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666226|NCT00362401|O3|Outcome|Group 3 - St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666227|NCT00362401|O2|Outcome|Group 2- Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666228|NCT00362401|O1|Outcome|Group 1 - ATS|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
666229|NCT00362375|B3|Baseline|Total|Total of all reporting groups
666230|NCT00362375|B2|Baseline|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666231|NCT00362375|B1|Baseline|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666232|NCT00362375|P2|Participant Flow|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666233|NCT00362375|P1|Participant Flow|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666287|NCT00362232|B2|Baseline|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666234|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666235|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666236|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666237|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666238|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666239|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666240|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666241|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666242|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666243|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666244|NCT00362375|E2|Reported Event|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
666245|NCT00362375|E1|Reported Event|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
666246|NCT00362336|B4|Baseline|Total|Total of all reporting groups
666247|NCT00362336|B3|Baseline|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666248|NCT00362336|B2|Baseline|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666249|NCT00362336|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666250|NCT00362336|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666251|NCT00362336|P2|Participant Flow|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666252|NCT00362336|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666253|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666254|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666255|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666256|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666257|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666258|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666259|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666260|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666261|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666262|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666263|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666264|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666265|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666266|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666267|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666268|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666269|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666270|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666271|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666272|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666273|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666274|NCT00362336|E3|Reported Event|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666275|NCT00362336|E2|Reported Event|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666276|NCT00362336|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
666277|NCT00362297|B3|Baseline|Total|Total of all reporting groups
666278|NCT00362297|B2|Baseline|High-dose|
666279|NCT00362297|B1|Baseline|Standard Dose|
666280|NCT00362297|P2|Participant Flow|High-dose|
666281|NCT00362297|P1|Participant Flow|Standard Dose|
666282|NCT00362297|O2|Outcome|High Dose Acyclovir|
666283|NCT00362297|O1|Outcome|Standardy Dose Valacyclovir|
666284|NCT00362297|E2|Reported Event|High-dose|
666285|NCT00362297|E1|Reported Event|Standard Dose|
666286|NCT00362232|B3|Baseline|Total|Total of all reporting groups
666418|NCT00362115|P4|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666288|NCT00362232|B1|Baseline|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666289|NCT00362232|P2|Participant Flow|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666290|NCT00362232|P1|Participant Flow|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666291|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666292|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666293|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666294|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666295|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666296|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666297|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666298|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666299|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666300|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666301|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666302|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666303|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666304|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666305|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666306|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666307|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666308|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666309|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666310|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666311|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666312|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666313|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666751|NCT00361270|P3|Participant Flow|Hypnosis Practice 2|2 sessions of hypnosis with practice cds
666314|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666315|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666316|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666317|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666318|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666319|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666320|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666321|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666322|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666323|NCT00362232|E2|Reported Event|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
666324|NCT00362232|E1|Reported Event|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
666325|NCT00362180|B10|Baseline|Total|Total of all reporting groups
666326|NCT00362180|B9|Baseline|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666327|NCT00362180|B8|Baseline|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666328|NCT00362180|B7|Baseline|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
666329|NCT00362180|B6|Baseline|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666330|NCT00362180|B5|Baseline|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666331|NCT00362180|B4|Baseline|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
666332|NCT00362180|B3|Baseline|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666333|NCT00362180|B2|Baseline|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666334|NCT00362180|B1|Baseline|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666335|NCT00362180|P9|Participant Flow|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666336|NCT00362180|P8|Participant Flow|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666337|NCT00362180|P7|Participant Flow|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
666338|NCT00362180|P6|Participant Flow|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666339|NCT00362180|P5|Participant Flow|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666340|NCT00362180|P4|Participant Flow|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
666341|NCT00362180|P3|Participant Flow|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666342|NCT00362180|P2|Participant Flow|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666343|NCT00362180|P1|Participant Flow|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666419|NCT00362115|P3|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666344|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666345|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666346|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
666347|NCT00362180|O5|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666348|NCT00362180|O4|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666349|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666350|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666351|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666352|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666353|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666354|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
666355|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666356|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666357|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666358|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666359|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666360|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666361|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666362|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
666363|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666364|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666365|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666366|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666367|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666368|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666369|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666370|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
666371|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666372|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666373|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666374|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666375|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666376|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
680277|NCT00323414|O1|Outcome|PUFA|Active treatment with PUFA
666377|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666378|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
666379|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666380|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666381|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666382|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666383|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666384|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666385|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666386|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
666387|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666388|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666389|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666390|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666391|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666392|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666393|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
666394|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
666395|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
666396|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
666397|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666398|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
666399|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
666400|NCT00362180|E3|Reported Event|Not Treated|Not Treated
666401|NCT00362180|E2|Reported Event|Mipomersen|Mipomersen
666402|NCT00362180|E1|Reported Event|Placebo|Placebo
666403|NCT00362128|B1|Baseline|Observational|The study design was a cross-sectional observational cohort design.
666404|NCT00362128|P1|Participant Flow|Observational|The study design was a cross-sectional observational cohort design.
666405|NCT00362128|O1|Outcome|Observational|The study design was a cross-sectional observational cohort design.
666406|NCT00362128|E1|Reported Event|Observational|The study design was a cross-sectional observational cohort design.
666407|NCT00362115|B8|Baseline|Total|Total of all reporting groups
666408|NCT00362115|B7|Baseline|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666409|NCT00362115|B6|Baseline|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666410|NCT00362115|B5|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666411|NCT00362115|B4|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666412|NCT00362115|B3|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666413|NCT00362115|B2|Baseline|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666414|NCT00362115|B1|Baseline|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666415|NCT00362115|P7|Participant Flow|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666416|NCT00362115|P6|Participant Flow|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666417|NCT00362115|P5|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666421|NCT00362115|P1|Participant Flow|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666422|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666423|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666424|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666425|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666426|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666427|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666428|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666429|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666430|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666431|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666432|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666433|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666434|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666435|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666436|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666437|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666438|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666439|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666440|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666441|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666442|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666443|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666444|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666445|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666446|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666447|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666448|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666449|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666450|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666451|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666452|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666453|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666454|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666455|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666456|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666457|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666458|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666459|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666460|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666461|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666462|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666463|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666464|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
681035|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
666465|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666466|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666467|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666468|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666469|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666470|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666471|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666472|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666473|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666474|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666475|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666476|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666477|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666478|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666479|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666480|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666481|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666482|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666483|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666484|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666485|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666486|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666487|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666488|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666489|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666490|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666491|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666492|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666493|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666494|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666495|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666496|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666497|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666498|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666499|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666500|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666501|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666502|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666503|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666504|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666505|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666506|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666507|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666508|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666509|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666510|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666511|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666512|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666513|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666514|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666515|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666516|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666517|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666518|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666519|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666520|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666521|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666522|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666523|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666524|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666525|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666526|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666527|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666528|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666529|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666530|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666531|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666532|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666533|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666534|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666535|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666536|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666537|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666538|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666539|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666540|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666541|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666542|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666543|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666544|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666545|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666546|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666547|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666548|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666549|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666550|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666551|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666552|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666553|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666554|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666555|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666556|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666557|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666558|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666559|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666560|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666561|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666562|NCT00362115|E7|Reported Event|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
666563|NCT00362115|E6|Reported Event|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666564|NCT00362115|E5|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666565|NCT00362115|E4|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666566|NCT00362115|E3|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666567|NCT00362115|E2|Reported Event|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666568|NCT00362115|E1|Reported Event|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
666569|NCT00361972|B3|Baseline|Total|Total of all reporting groups
666570|NCT00361972|B2|Baseline|Placebo|placebo comparator to lansoprazole 30 mg twice daily for 6 weeks
666571|NCT00361972|B1|Baseline|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
666572|NCT00361972|P2|Participant Flow|Placebo|placebo comparator to lansoprazole, 30 mg, twice a day for 6 weeks
666573|NCT00361972|P1|Participant Flow|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
666574|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
666575|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
666576|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
666577|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole: 30 mg lansoprazole twice daily for 6 weeks
666578|NCT00361972|E2|Reported Event|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
666579|NCT00361972|E1|Reported Event|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
666580|NCT00361712|B3|Baseline|Total|Total of all reporting groups
666581|NCT00361712|B2|Baseline|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
666582|NCT00361712|B1|Baseline|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
666583|NCT00361712|P2|Participant Flow|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
666584|NCT00361712|P1|Participant Flow|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
666585|NCT00361712|O2|Outcome|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
666586|NCT00361712|O1|Outcome|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
666587|NCT00361712|O2|Outcome|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
666588|NCT00361712|O1|Outcome|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
666589|NCT00361712|O2|Outcome|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
666590|NCT00361712|O1|Outcome|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
666591|NCT00361712|E2|Reported Event|Randomized to Epidural Analgesia Upon Request|Parturient's pain was monitored every 15 min until it reached a level of >50 on the VAS and then epidural analgesia was initiated.
666592|NCT00361712|E1|Reported Event|Randomized to Early Epidural Analgesia|Parturients were allocated to receive epidural analgesia immediately on admission, before the onset of painful contractions
666593|NCT00361634|B1|Baseline|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666594|NCT00361634|P1|Participant Flow|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666595|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666596|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666597|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666600|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666601|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666602|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666603|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666604|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666605|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666606|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666607|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666608|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666609|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666610|NCT00361634|E1|Reported Event|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
666611|NCT00361595|B1|Baseline|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
666612|NCT00361595|P1|Participant Flow|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
666613|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
666614|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
666615|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
666616|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
666617|NCT00361595|E1|Reported Event|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
666618|NCT00361569|B5|Baseline|Total|Total of all reporting groups
666619|NCT00361569|B4|Baseline|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666620|NCT00361569|B3|Baseline|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666621|NCT00361569|B2|Baseline|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666622|NCT00361569|B1|Baseline|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666623|NCT00361569|P4|Participant Flow|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666624|NCT00361569|P3|Participant Flow|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666625|NCT00361569|P2|Participant Flow|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666626|NCT00361569|P1|Participant Flow|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666627|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666628|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666629|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666630|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666631|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666632|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666633|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666634|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666635|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666636|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666637|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666638|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666639|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666640|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666641|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666642|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666643|NCT00361569|E4|Reported Event|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666644|NCT00361569|E3|Reported Event|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666645|NCT00361569|E2|Reported Event|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
666646|NCT00361569|E1|Reported Event|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
666647|NCT00361504|B3|Baseline|Total|Total of all reporting groups
666648|NCT00361504|B2|Baseline|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
666752|NCT00361270|P2|Participant Flow|Hypnosis-Practice 8|8 sessions hypnosis with practice cds
666649|NCT00361504|B1|Baseline|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
666650|NCT00361504|P2|Participant Flow|Oxycodone|Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
666651|NCT00361504|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
666652|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
666653|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
666654|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
666655|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
666656|NCT00361504|E2|Reported Event|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
666657|NCT00361504|E1|Reported Event|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
666658|NCT00361439|B3|Baseline|Total|Total of all reporting groups
666659|NCT00361439|B2|Baseline|Placebo|2 puffs of placebo spray once daily
666660|NCT00361439|B1|Baseline|Mometasone|Active intranasal steroid therapy daily for 2 weeks
666661|NCT00361439|P2|Participant Flow|Placebo|2 puffs of placebo spray once daily
666662|NCT00361439|P1|Participant Flow|Mometasone|Active intranasal steroid therapy daily for 2 weeks
666663|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
666664|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
666665|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
666666|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
666667|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
666668|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
666669|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
666670|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
666671|NCT00361439|E2|Reported Event|Placebo|2 puffs of placebo spray once daily
666672|NCT00361439|E1|Reported Event|Mometasone|Active intranasal steroid therapy daily for 2 weeks
666673|NCT00361374|B4|Baseline|Total|Total of all reporting groups
666674|NCT00361374|B3|Baseline|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
666675|NCT00361374|B2|Baseline|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
666676|NCT00361374|B1|Baseline|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
666677|NCT00361374|P3|Participant Flow|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
666678|NCT00361374|P2|Participant Flow|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
666679|NCT00361374|P1|Participant Flow|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
666680|NCT00361374|O3|Outcome|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
666681|NCT00361374|O2|Outcome|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
666682|NCT00361374|O1|Outcome|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
666683|NCT00361374|E3|Reported Event|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
666684|NCT00361374|E2|Reported Event|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
666685|NCT00361374|E1|Reported Event|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
666686|NCT00361335|B6|Baseline|Total|Total of all reporting groups
666687|NCT00361335|B5|Baseline|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
666688|NCT00361335|B4|Baseline|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
666689|NCT00361335|B3|Baseline|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
666690|NCT00361335|B2|Baseline|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
666691|NCT00361335|B1|Baseline|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
666717|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
666753|NCT00361270|P1|Participant Flow|Hypnosis-8|8 sessions of hypnosis with no practice cds
666754|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback no recordings
666692|NCT00361335|P7|Participant Flow|EE/DRA -> 4mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
666693|NCT00361335|P6|Participant Flow|EE/DRA -> 2mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
666694|NCT00361335|P5|Participant Flow|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
666695|NCT00361335|P4|Participant Flow|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
666696|NCT00361335|P3|Participant Flow|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
666697|NCT00361335|P2|Participant Flow|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
666698|NCT00361335|P1|Participant Flow|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
666699|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
666700|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
666701|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
666702|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666703|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
666704|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666705|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
666706|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
666707|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
666708|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
666709|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666710|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
666711|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666712|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
666713|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
666714|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
666715|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
666716|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666718|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666719|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
666720|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
666721|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
666722|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
666723|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666724|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
666725|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666726|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
666727|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
666728|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
666729|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
666730|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666731|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
666732|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
666733|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
666734|NCT00361335|E7|Reported Event|SC Period: 50mg Golimumab Only|Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
666735|NCT00361335|E6|Reported Event|SC Period: 50mg Golimumab + MTX|Participants who received 50mg SC golimumab and MTX.
666736|NCT00361335|E5|Reported Event|IV Period: Placebo + MTX|Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
666737|NCT00361335|E4|Reported Event|IV Period: 4mg/kg Golimumab Only|Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
666738|NCT00361335|E3|Reported Event|IV Period: 4mg/kg Golimumab + MTX|Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
666739|NCT00361335|E2|Reported Event|IV Period: 2mg/kg Golimumab Only|Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
666740|NCT00361335|E1|Reported Event|IV Period: 2mg/kg Golimumab+ MTX|Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
666741|NCT00361283|B1|Baseline|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
666742|NCT00361283|P1|Participant Flow|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
666743|NCT00361283|O1|Outcome|Atorvastatin 80 MG/Day|Atorvastatin 80 MG/day
666744|NCT00361283|E1|Reported Event|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
666745|NCT00361270|B5|Baseline|Total|Total of all reporting groups
666746|NCT00361270|B4|Baseline|Arm 4|"Single-site study at MEDVA-Houston~EMG Biofeedback without hypnotic suggestion: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion"
666747|NCT00361270|B3|Baseline|Arm 3|"Single-site study at MEDVA-Houston~Home practice with hypnosis CDs: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs"
666748|NCT00361270|B2|Baseline|Arm 2|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis with home practice with hypnosis CDs"
666749|NCT00361270|B1|Baseline|Arm 1|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis"
666750|NCT00361270|P4|Participant Flow|Biofeedback - 8|8 sessions biofeedback
666755|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist and audio recordings
666756|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist and audio recordings
666757|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
666758|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
666759|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
666760|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapists with audio recordings
666761|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis with hypnotherapist without recordings
666762|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback
666763|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions of hypnosis with audio recordings
666764|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions of hypnosis with audio recordings
666765|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
666766|NCT00361270|E4|Reported Event|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
666767|NCT00361270|E3|Reported Event|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
666768|NCT00361270|E2|Reported Event|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist with audio recordings
666769|NCT00361270|E1|Reported Event|Hypnosis-8|8 1-hour sessions with hypnotherapist
666770|NCT00361257|B3|Baseline|Total|Total of all reporting groups
666771|NCT00361257|B2|Baseline|Matching Placebo|Placebo taken orally every 12 hours
666772|NCT00361257|B1|Baseline|Minocycline|100 mg orally every 12 hours
666773|NCT00361257|P2|Participant Flow|Matching Placebo|Placebo taken orally every 12 hours
666774|NCT00361257|P1|Participant Flow|Minocycline|100 mg orally every 12 hours
666775|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666776|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666777|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666778|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666779|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666780|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666781|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
666782|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
666783|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
666784|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
666785|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
666786|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
666787|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
666788|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
666789|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666790|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666791|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666792|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666793|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666794|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666795|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666796|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666797|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666798|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666799|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666800|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666801|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666802|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666803|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666804|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666805|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666806|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666807|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666808|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666809|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666810|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666811|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666812|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666813|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666814|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666815|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666816|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666817|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666818|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666819|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666820|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666821|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
666822|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
666823|NCT00361257|E2|Reported Event|Matching Placebo|Placebo taken orally every 12 hours
666824|NCT00361257|E1|Reported Event|Minocycline|100 mg orally every 12 hours
666825|NCT00361231|B1|Baseline|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
666826|NCT00361231|P1|Participant Flow|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
666827|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Oxaliplatin"
666828|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Oxaliplatin"
666829|NCT00361231|E1|Reported Event|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side eff"
666830|NCT00361218|B1|Baseline|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
666831|NCT00361218|P1|Participant Flow|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
666832|NCT00361218|O1|Outcome|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
666833|NCT00361218|O1|Outcome|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
666834|NCT00361218|E1|Reported Event|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
666835|NCT00361140|B4|Baseline|Total|Total of all reporting groups
666836|NCT00361140|B3|Baseline|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
666837|NCT00361140|B2|Baseline|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
666838|NCT00361140|B1|Baseline|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
666839|NCT00361140|P3|Participant Flow|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
666840|NCT00361140|P2|Participant Flow|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
666841|NCT00361140|P1|Participant Flow|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
666842|NCT00361140|O3|Outcome|AUC 9000|Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
666843|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
666844|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
666845|NCT00361140|O3|Outcome|AUC 9000|Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
666846|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
666847|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
666848|NCT00361140|E3|Reported Event|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
666849|NCT00361140|E2|Reported Event|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
666850|NCT00361140|E1|Reported Event|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
666851|NCT00360971|B3|Baseline|Total|Total of all reporting groups
666852|NCT00360971|B2|Baseline|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666853|NCT00360971|B1|Baseline|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666854|NCT00360971|P2|Participant Flow|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666855|NCT00360971|P1|Participant Flow|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666856|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666857|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666858|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666859|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666860|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666861|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666862|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666863|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666864|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666865|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666866|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666867|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666868|NCT00360971|E2|Reported Event|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
666869|NCT00360971|E1|Reported Event|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
666870|NCT00360828|B1|Baseline|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
666871|NCT00360828|P1|Participant Flow|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
666872|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
666873|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
667097|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
666874|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
666875|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
666876|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
666877|NCT00360828|E1|Reported Event|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
666878|NCT00360724|B3|Baseline|Total|Total of all reporting groups
666879|NCT00360724|B2|Baseline|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666880|NCT00360724|B1|Baseline|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666881|NCT00360724|P2|Participant Flow|Placebo Treatment|placebo treatment, treatment with matching capsules of placebo
666882|NCT00360724|P1|Participant Flow|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666883|NCT00360724|O2|Outcome|Placebo Treatment|"placebo treatment: treatment with placebo capsules that match active medication capsules~Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
666884|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|"Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine~Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
666885|NCT00360724|O2|Outcome|Placebo Treatment|"placebo treatment: treatment with placebo capsules that match active medication capsules~Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
666886|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|"Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine~Duloxetine (Cymbalta): duloxetine medication up to dose of 120 mg/day"
666887|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666888|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666889|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666890|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666891|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666892|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666893|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666894|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666895|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666896|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666897|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666898|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666899|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666900|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666901|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
666902|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666903|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
666904|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666905|NCT00360724|E2|Reported Event|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
666906|NCT00360724|E1|Reported Event|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
666907|NCT00360698|B3|Baseline|Total|Total of all reporting groups
666908|NCT00360698|B2|Baseline|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
667098|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
667099|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
666909|NCT00360698|B1|Baseline|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666910|NCT00360698|P2|Participant Flow|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666911|NCT00360698|P1|Participant Flow|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666912|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666913|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666914|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666915|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666916|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666917|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666918|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666919|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666920|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666921|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666922|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666923|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666924|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666925|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666926|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666927|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666928|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666929|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666930|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666931|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666932|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666933|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666934|NCT00360698|E2|Reported Event|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
667100|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667101|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
666935|NCT00360698|E1|Reported Event|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
666936|NCT00360685|B3|Baseline|Total|Total of all reporting groups
666937|NCT00360685|B2|Baseline|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
666938|NCT00360685|B1|Baseline|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
666939|NCT00360685|P2|Participant Flow|Tacrolimus And Mycophenolate Mofetil|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MMF 30 mg/kg/day IV in 2 divided doses beginning day 0. Dosing should be based on the lesser of adjusted ideal body weight or actual body weight. The IV dose will be converted to the oral formulation when spatient is able to tolerate oral medications. Oral dosing may be capped at 1 gram twice daily. In the absence of GVHD a tapering schedule will begin on day +240 (+14) and be completed on day +360 (+14)."
666940|NCT00360685|P1|Participant Flow|Tacrolimus And Methotrexate|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3 (day 0 being the anticipated day of hematopoietic stem cell infusion). Tacrolimus dosing should be based on ideal body weight. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing at a 1:3 (IV:PO) ratio. The daily oral dose will be divided into twice daily dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MTX 15 mg/m2 IV day +1 then 10 mg/m2 IV on days +3, +6, and +11."
666941|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
666942|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
666943|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
666944|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
666945|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
666946|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus And Methotrexate
666947|NCT00360685|E2|Reported Event|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
666948|NCT00360685|E1|Reported Event|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
666949|NCT00360672|B1|Baseline|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
666950|NCT00360672|P1|Participant Flow|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
666951|NCT00360672|O1|Outcome|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
666952|NCT00360672|E1|Reported Event|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
666953|NCT00360568|B3|Baseline|Total|Total of all reporting groups
666954|NCT00360568|B2|Baseline|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666955|NCT00360568|B1|Baseline|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666956|NCT00360568|P2|Participant Flow|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666957|NCT00360568|P1|Participant Flow|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667102|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
666958|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666959|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666960|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666961|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666962|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666963|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666964|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666965|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666966|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666967|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667103|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667104|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
666968|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666969|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666970|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666971|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666972|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666973|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666974|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666975|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666976|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666977|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666978|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666979|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666980|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666981|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666982|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666983|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666984|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666985|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666986|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666987|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667105|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
666988|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666989|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666990|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666991|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666992|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666993|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666994|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
666995|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666996|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
666997|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667106|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667107|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
666998|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
666999|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667000|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667001|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667002|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667003|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667004|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667005|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667006|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667007|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667008|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667009|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667010|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667011|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667012|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667013|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667014|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667015|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667016|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667017|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667108|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
667018|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667019|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667020|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667021|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667022|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667023|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667024|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667025|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667026|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667027|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667109|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667110|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
667028|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667029|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667030|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667031|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667032|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667033|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667034|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667035|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667036|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667037|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667038|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667039|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667040|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667041|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667042|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667043|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667044|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667045|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667046|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667047|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667111|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
667048|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667049|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667050|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667051|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667052|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667053|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667054|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667055|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667056|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667057|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667112|NCT00360529|E3|Reported Event|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667113|NCT00360529|E2|Reported Event|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
667058|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667059|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667060|NCT00360568|E3|Reported Event|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
667061|NCT00360568|E2|Reported Event|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
667062|NCT00360568|E1|Reported Event|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
667063|NCT00360555|B5|Baseline|Total|Total of all reporting groups
667064|NCT00360555|B4|Baseline|Placebo|flibanserin: placebo
667065|NCT00360555|B3|Baseline|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
667066|NCT00360555|B2|Baseline|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
667067|NCT00360555|B1|Baseline|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
667068|NCT00360555|P4|Participant Flow|Placebo|flibanserin: placebo
667069|NCT00360555|P3|Participant Flow|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
667070|NCT00360555|P2|Participant Flow|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
667071|NCT00360555|P1|Participant Flow|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
667072|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
667073|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
667074|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
667075|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
667076|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
667077|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
667078|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
667079|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
667080|NCT00360555|E4|Reported Event|Placebo|flibanserin: placebo
667081|NCT00360555|E3|Reported Event|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
667082|NCT00360555|E2|Reported Event|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
667083|NCT00360555|E1|Reported Event|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
667084|NCT00360529|B4|Baseline|Total|Total of all reporting groups
667085|NCT00360529|B3|Baseline|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667086|NCT00360529|B2|Baseline|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
667087|NCT00360529|B1|Baseline|Placebo|placebo at bedtime
667088|NCT00360529|P3|Participant Flow|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667089|NCT00360529|P2|Participant Flow|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
667090|NCT00360529|P1|Participant Flow|Placebo|placebo at bedtime
667091|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667092|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
667093|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
667094|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
667095|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
667096|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
667116|NCT00360490|B2|Baseline|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667117|NCT00360490|B1|Baseline|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667118|NCT00360490|P2|Participant Flow|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667119|NCT00360490|P1|Participant Flow|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667120|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667121|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667122|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667123|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667124|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667125|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667126|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667127|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667128|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667129|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667130|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667131|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667132|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667133|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667134|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667135|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667136|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667137|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667138|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667139|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667140|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667141|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667142|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667143|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667144|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667145|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667146|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667147|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667148|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667149|NCT00360490|E2|Reported Event|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
667150|NCT00360490|E1|Reported Event|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
667151|NCT00360412|B3|Baseline|Total|Total of all reporting groups
667152|NCT00360412|B2|Baseline|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667153|NCT00360412|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667154|NCT00360412|P2|Participant Flow|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667155|NCT00360412|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667156|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667157|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667158|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667159|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667160|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667161|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667162|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667163|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667164|NCT00360412|E2|Reported Event|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667165|NCT00360412|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
667166|NCT00360399|B4|Baseline|Total|Total of all reporting groups
667167|NCT00360399|B3|Baseline|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667168|NCT00360399|B2|Baseline|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667169|NCT00360399|B1|Baseline|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667170|NCT00360399|P3|Participant Flow|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667171|NCT00360399|P2|Participant Flow|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667172|NCT00360399|P1|Participant Flow|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667173|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667174|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667175|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667176|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667177|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667178|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667179|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667180|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667181|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667182|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667183|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667184|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667185|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667186|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667187|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667188|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667189|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667190|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667191|NCT00360399|E3|Reported Event|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
667192|NCT00360399|E2|Reported Event|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
667193|NCT00360399|E1|Reported Event|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
667194|NCT00360360|B1|Baseline|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
667195|NCT00360360|P1|Participant Flow|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
667196|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
667197|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
667198|NCT00360360|E1|Reported Event|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
667199|NCT00360334|B3|Baseline|Total|Total of all reporting groups
667200|NCT00360334|B2|Baseline|Insulin Glargine|dosing based on treat to target protocol
667201|NCT00360334|B1|Baseline|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667202|NCT00360334|P2|Participant Flow|Insulin Glargine|dosing based on treat to target protocol
667203|NCT00360334|P1|Participant Flow|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667204|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667205|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667206|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667207|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667208|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667209|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667210|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667211|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667212|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667213|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667214|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667215|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667216|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667217|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667218|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667219|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667220|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667221|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667222|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667223|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667224|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667225|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667226|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667227|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667228|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667229|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667230|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667231|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667232|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667233|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667234|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667235|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667236|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667237|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667238|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667239|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667240|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667241|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667242|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667243|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667244|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667245|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667246|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667247|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667248|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667249|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667250|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667251|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667252|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667253|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667254|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667255|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667256|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667257|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667258|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
667259|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667260|NCT00360334|E2|Reported Event|Insulin Glargine|dosing based on treat to target protocol
667261|NCT00360334|E1|Reported Event|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
667262|NCT00360308|B4|Baseline|Total|Total of all reporting groups
667263|NCT00360308|B3|Baseline|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667264|NCT00360308|B2|Baseline|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
667265|NCT00360308|B1|Baseline|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667266|NCT00360308|P3|Participant Flow|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667267|NCT00360308|P2|Participant Flow|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
667268|NCT00360308|P1|Participant Flow|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667269|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667270|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
667271|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667272|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667273|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
667274|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 1 fewer subject due to inavailability of the data
667275|NCT00360308|O3|Outcome|Perampanel|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
667276|NCT00360308|O2|Outcome|Entacapone|The total number of subjects reflects 5 fewer subjects due to inavailability of the data
667277|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
667278|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667279|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
667280|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667281|NCT00360308|E3|Reported Event|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667282|NCT00360308|E2|Reported Event|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
667283|NCT00360308|E1|Reported Event|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
667284|NCT00360282|B1|Baseline|All Study Participants|Includes participants (migraineurs) with and without vertigo
667285|NCT00360282|P4|Participant Flow|Without Vertigo; Rizatriptan - Placebo|These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
667286|NCT00360282|P3|Participant Flow|With Vertigo; Rizatriptan - Placebo|These participants suffered from migraine and had associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
667287|NCT00360282|P2|Participant Flow|Without Vertigo; Placebo - Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. This group received placebo on visit 1 and Rizatriptan on visit 2.
667288|NCT00360282|P1|Participant Flow|With Vertigo; Placebo-Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They were given placebo on visit one and Rizatriptan on visit 2.
667289|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
667290|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
667291|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
667292|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
667293|NCT00360282|E4|Reported Event|With Vertigo; Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They received Rizatriptan on one of the visits.
667294|NCT00360282|E3|Reported Event|With Vertigo; Placebo|These participants suffered from migraines with associated dizziness/vertigo. They received Placebo on one of the visits.
667295|NCT00360282|E2|Reported Event|Without Vertigo; Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Rizatriptan on one of the visits.
667296|NCT00360282|E1|Reported Event|Without Vertigo; Placebo|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Placebo on one of the visits.
667297|NCT00360269|B3|Baseline|Total|Total of all reporting groups
667298|NCT00360269|B2|Baseline|Placebo|Flexible dose up to 100mg/day
667299|NCT00360269|B1|Baseline|Atomoxetine|Flexible dose up to 100mg/day
667300|NCT00360269|P2|Participant Flow|Placebo|Flexible dose up to 100mg/day
667301|NCT00360269|P1|Participant Flow|Atomoxetine|Flexible dose up to 100mg/day
667302|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
667303|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
667304|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
667305|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
667306|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
667307|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
667308|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
667309|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
667310|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
667311|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
667312|NCT00360269|E2|Reported Event|Placebo|Flexible dose up to 100mg/day
667313|NCT00360269|E1|Reported Event|Atomoxetine|Flexible dose up to 100mg/day
667314|NCT00360243|B5|Baseline|Total|Total of all reporting groups
667315|NCT00360243|B4|Baseline|Placebo|"twice daily for 24 weeks~placebo: placebo"
667316|NCT00360243|B3|Baseline|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
667317|NCT00360243|B2|Baseline|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
667318|NCT00360243|B1|Baseline|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
667319|NCT00360243|P4|Participant Flow|Placebo|"twice daily for 24 weeks~placebo: placebo"
667320|NCT00360243|P3|Participant Flow|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
667321|NCT00360243|P2|Participant Flow|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
667322|NCT00360243|P1|Participant Flow|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
667323|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks~placebo: placebo"
667324|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
667325|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
667326|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
667327|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks~placebo: placebo"
667328|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
667329|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
667330|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
667331|NCT00360243|E4|Reported Event|Placebo|"twice daily for 24 weeks~placebo: placebo"
667332|NCT00360243|E3|Reported Event|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
667333|NCT00360243|E2|Reported Event|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
667334|NCT00360243|E1|Reported Event|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
667335|NCT00360230|B8|Baseline|Total|Total of all reporting groups
667336|NCT00360230|B7|Baseline|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667337|NCT00360230|B6|Baseline|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667338|NCT00360230|B5|Baseline|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667339|NCT00360230|B4|Baseline|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667340|NCT00360230|B3|Baseline|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667341|NCT00360230|B2|Baseline|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667342|NCT00360230|B1|Baseline|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667343|NCT00360230|P7|Participant Flow|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667344|NCT00360230|P6|Participant Flow|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667345|NCT00360230|P5|Participant Flow|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667346|NCT00360230|P4|Participant Flow|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667347|NCT00360230|P3|Participant Flow|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667348|NCT00360230|P2|Participant Flow|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667349|NCT00360230|P1|Participant Flow|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667350|NCT00360230|O7|Outcome|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667351|NCT00360230|O6|Outcome|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667352|NCT00360230|O5|Outcome|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667353|NCT00360230|O4|Outcome|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667354|NCT00360230|O3|Outcome|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667355|NCT00360230|O2|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667356|NCT00360230|O1|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667357|NCT00360230|O7|Outcome|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667358|NCT00360230|O6|Outcome|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667359|NCT00360230|O5|Outcome|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667360|NCT00360230|O4|Outcome|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667361|NCT00360230|O3|Outcome|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667362|NCT00360230|O2|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667363|NCT00360230|O1|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667364|NCT00360230|O7|Outcome|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667365|NCT00360230|O6|Outcome|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667366|NCT00360230|O5|Outcome|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667367|NCT00360230|O4|Outcome|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667368|NCT00360230|O3|Outcome|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667369|NCT00360230|O2|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667370|NCT00360230|O1|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667371|NCT00360230|O7|Outcome|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667372|NCT00360230|O6|Outcome|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667373|NCT00360230|O5|Outcome|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667374|NCT00360230|O4|Outcome|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667375|NCT00360230|O3|Outcome|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667376|NCT00360230|O2|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667377|NCT00360230|O1|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667536|NCT00359801|E1|Reported Event|Exubera®|Exubera® plus usual diabetes care
667378|NCT00360230|O7|Outcome|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667379|NCT00360230|O6|Outcome|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667380|NCT00360230|O5|Outcome|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667381|NCT00360230|O4|Outcome|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667382|NCT00360230|O3|Outcome|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667383|NCT00360230|O2|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667384|NCT00360230|O1|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667385|NCT00360230|O7|Outcome|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667386|NCT00360230|O6|Outcome|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667387|NCT00360230|O5|Outcome|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667388|NCT00360230|O4|Outcome|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667389|NCT00360230|O3|Outcome|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667390|NCT00360230|O2|Outcome|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667391|NCT00360230|O1|Outcome|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667392|NCT00360230|E7|Reported Event|SB257049 F1 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667393|NCT00360230|E6|Reported Event|SB257049 F2 0-1-7 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667394|NCT00360230|E5|Reported Event|Rabipur 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667395|NCT00360230|E4|Reported Event|SB257049 F1 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667396|NCT00360230|E3|Reported Event|SB257049 F2 0-1-2 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667397|NCT00360230|E2|Reported Event|SB257049 F1 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667398|NCT00360230|E1|Reported Event|SB257049 F2 0-1 M Group|Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
667399|NCT00360126|B1|Baseline|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
667400|NCT00360126|P1|Participant Flow|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
667401|NCT00360126|O1|Outcome|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
667402|NCT00360126|E1|Reported Event|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
667403|NCT00360009|B4|Baseline|Total|Total of all reporting groups
667537|NCT00359788|B3|Baseline|Total|Total of all reporting groups
667404|NCT00360009|B3|Baseline|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667405|NCT00360009|B2|Baseline|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667406|NCT00360009|B1|Baseline|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667407|NCT00360009|P3|Participant Flow|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667408|NCT00360009|P2|Participant Flow|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667409|NCT00360009|P1|Participant Flow|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667410|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667411|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667412|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667413|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667414|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667415|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667416|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667417|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667418|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667419|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667420|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667421|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667422|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667423|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667424|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667425|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667426|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667427|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667428|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667429|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667430|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667431|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667432|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667433|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667434|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667435|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667436|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667437|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667438|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667439|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667440|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667441|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667442|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667443|NCT00360009|E3|Reported Event|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
667444|NCT00360009|E2|Reported Event|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
667445|NCT00360009|E1|Reported Event|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
667446|NCT00359983|B4|Baseline|Total|Total of all reporting groups
667447|NCT00359983|B3|Baseline|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667448|NCT00359983|B2|Baseline|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667449|NCT00359983|B1|Baseline|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667450|NCT00359983|P3|Participant Flow|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667451|NCT00359983|P2|Participant Flow|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667452|NCT00359983|P1|Participant Flow|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667453|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667454|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667455|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667456|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667457|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667458|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667459|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667460|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667461|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667462|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667463|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667464|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667465|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667466|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667467|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667468|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667469|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667470|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667471|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667472|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667473|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667474|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667475|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667476|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667477|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667478|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667479|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667480|NCT00359983|E3|Reported Event|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667481|NCT00359983|E2|Reported Event|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667482|NCT00359983|E1|Reported Event|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
667483|NCT00359944|B4|Baseline|Total|Total of all reporting groups
667484|NCT00359944|B3|Baseline|Placebo|Sugar Pill twice daily
667485|NCT00359944|B2|Baseline|AC-3933, 20 mg|AC-3933, 20 mg twice daily
667486|NCT00359944|B1|Baseline|AC-3933|AC-3933, 5mg twice daily
667487|NCT00359944|P3|Participant Flow|Placebo|Sugar Pill twice daily
667488|NCT00359944|P2|Participant Flow|AC-3933, 20 mg|AC-3933, 20 mg twice daily
667489|NCT00359944|P1|Participant Flow|AC-3933, 5 mg|AC-3933, 5mg twice daily
667490|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
667491|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
667492|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
667493|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
667494|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
667495|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
667496|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
667497|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
667498|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
667499|NCT00359944|E3|Reported Event|Placebo|Sugar Pill twice daily
667500|NCT00359944|E2|Reported Event|AC-3933, 20 mg|AC-3933, 20 mg twice daily
667501|NCT00359944|E1|Reported Event|AC-3933, 5 mg|AC-3933, 5mg twice daily
667502|NCT00359801|B3|Baseline|Total|Total of all reporting groups
667503|NCT00359801|B2|Baseline|Non-Exubera®|Usual diabetes care
667504|NCT00359801|B1|Baseline|Exubera®|Exubera® plus usual diabetes care
667505|NCT00359801|P2|Participant Flow|Non-Exubera®|Usual diabetes care
667506|NCT00359801|P1|Participant Flow|Exubera®|Exubera® plus usual diabetes care
667507|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
667508|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
667509|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
667510|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
667511|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
667512|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
667513|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
667514|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
667515|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
667516|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
667517|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
667538|NCT00359788|B2|Baseline|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667539|NCT00359788|B1|Baseline|Tiotropium|18 mcg once daily
667540|NCT00359788|P2|Participant Flow|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667541|NCT00359788|P1|Participant Flow|Tiotropium|18 mcg once daily
667542|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667543|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667544|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667545|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667546|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667547|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667548|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667549|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667550|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667551|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667552|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667553|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667554|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667555|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667556|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667557|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667558|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667559|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667560|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667561|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667562|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667563|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667564|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667565|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667566|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667567|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667568|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667569|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667570|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667571|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667572|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667573|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667574|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667575|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667576|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667577|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667578|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667579|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667580|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667581|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667582|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667583|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667584|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667585|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667586|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667587|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667588|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667589|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667590|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667591|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667592|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667593|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667594|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667595|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667596|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667597|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667598|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667599|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667600|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667601|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667602|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667603|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667604|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667605|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667606|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667607|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667608|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667609|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667610|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667611|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667612|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667613|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667614|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667615|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667616|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667617|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667618|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667620|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667621|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667622|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667623|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667624|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667625|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667626|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667627|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667628|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667629|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667630|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667631|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667632|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667633|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667634|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667635|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667636|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667637|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667638|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667639|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667640|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667641|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667642|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667643|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667644|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667645|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667646|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667647|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667648|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667649|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667650|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667651|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667652|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667653|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667654|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667655|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667656|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667657|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667658|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667659|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667660|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667661|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667662|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667663|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667664|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667665|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667666|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667667|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667668|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667669|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667670|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667671|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667672|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667673|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667674|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667675|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667676|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667677|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667678|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667679|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667680|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667681|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667682|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667683|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667684|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667685|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667686|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667687|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667688|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667689|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667690|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667691|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667692|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667693|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667694|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667695|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667696|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667697|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667698|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667699|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667700|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667702|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667703|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667704|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667705|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667706|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667707|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667708|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667709|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667710|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667711|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667712|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667713|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667714|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667715|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667716|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667717|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667718|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667719|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667720|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667721|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667722|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667723|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667724|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667725|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667726|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667727|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667728|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667729|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667730|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667731|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667732|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667733|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667734|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667735|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667736|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667737|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667738|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667739|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667740|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667741|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667742|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667743|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667744|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667745|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667746|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667747|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667748|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667749|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667750|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667751|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667752|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667753|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667754|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667755|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667756|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667757|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667758|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667759|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667760|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667761|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667762|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667763|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667764|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667765|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667766|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667767|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667768|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667769|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
667770|NCT00359788|E2|Reported Event|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
667771|NCT00359788|E1|Reported Event|Tiotropium|18 mcg once daily
667772|NCT00359762|B3|Baseline|Total|Total of all reporting groups
667773|NCT00359762|B2|Baseline|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667774|NCT00359762|B1|Baseline|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667775|NCT00359762|P5|Participant Flow|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667806|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667776|NCT00359762|P4|Participant Flow|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
667777|NCT00359762|P3|Participant Flow|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667778|NCT00359762|P2|Participant Flow|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667779|NCT00359762|P1|Participant Flow|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667780|NCT00359762|O3|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
667781|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667782|NCT00359762|O1|Outcome|Exen + Metformin + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667783|NCT00359762|O1|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
667784|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667785|NCT00359762|O1|Outcome|Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667786|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667787|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667788|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667789|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667790|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667791|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667792|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667793|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667794|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667795|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667796|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667797|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667798|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667799|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667800|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667801|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667802|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667803|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667804|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667805|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667807|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667808|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667809|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667810|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667811|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667812|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667813|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667814|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667815|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667816|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667817|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667818|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667819|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667820|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667821|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667822|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667823|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667824|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667825|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667826|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667827|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667828|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667829|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667830|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667831|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667832|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667833|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667834|NCT00359762|E5|Reported Event|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
667835|NCT00359762|E4|Reported Event|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
667836|NCT00359762|E3|Reported Event|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667837|NCT00359762|E2|Reported Event|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
667838|NCT00359762|E1|Reported Event|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
667839|NCT00359736|B3|Baseline|Total|Total of all reporting groups
667840|NCT00359736|B2|Baseline|Placebo|Identical Placebo: 20 mg TID orally
667841|NCT00359736|B1|Baseline|Sildenafil|Sildenafil 20 mg TID orally: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
667842|NCT00359736|P2|Participant Flow|Placebo|Control group: Identical Placebo 20 mg TID orally
667843|NCT00359736|P1|Participant Flow|Sildenafil|Sildenafil 20 mg TID orally : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
667844|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20mg tid orally
667845|NCT00359736|O1|Outcome|Sildenafil|Sildenafil 20 mg tid orally
667846|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20 mg tid
667847|NCT00359736|O1|Outcome|Sildenafil|"Sildenafil 20 mg tid~sildenafil: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients."
667848|NCT00359736|E2|Reported Event|Sildenafil|sildenafil : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
667849|NCT00359736|E1|Reported Event|Placebo|Control group
667850|NCT00359632|B3|Baseline|Total|Total of all reporting groups
667851|NCT00359632|B2|Baseline|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
667852|NCT00359632|B1|Baseline|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
667853|NCT00359632|P2|Participant Flow|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
667854|NCT00359632|P1|Participant Flow|Linezolid|Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
667855|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
667856|NCT00359632|O2|Outcome|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
667857|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
667858|NCT00359632|E2|Reported Event|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
667859|NCT00359632|E1|Reported Event|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
667860|NCT00359619|B8|Baseline|Total|Total of all reporting groups
667861|NCT00359619|B7|Baseline|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667862|NCT00359619|B6|Baseline|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667863|NCT00359619|B5|Baseline|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667864|NCT00359619|B4|Baseline|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667865|NCT00359619|B3|Baseline|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667866|NCT00359619|B2|Baseline|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667867|NCT00359619|B1|Baseline|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667868|NCT00359619|P7|Participant Flow|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667869|NCT00359619|P6|Participant Flow|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667870|NCT00359619|P5|Participant Flow|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667871|NCT00359619|P4|Participant Flow|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667872|NCT00359619|P3|Participant Flow|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667873|NCT00359619|P2|Participant Flow|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667874|NCT00359619|P1|Participant Flow|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667875|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667876|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667877|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667878|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667879|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667880|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667881|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667882|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667883|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667884|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667885|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667886|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667887|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667888|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667889|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667890|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667891|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667892|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
668116|NCT00359073|P1|Participant Flow|Montelukast|subjects received study drug montelukast, 10 mg once per day
667893|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667894|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667895|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667896|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667897|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667898|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667899|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667900|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667901|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667902|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667903|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667904|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667905|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667906|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667907|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667908|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667909|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667910|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667911|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667912|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667913|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667914|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667915|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667916|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667917|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667918|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667919|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667920|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667921|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667922|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667923|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667924|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667925|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667926|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667927|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667928|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667929|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667930|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667931|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667932|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667933|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667934|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667935|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667936|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667937|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667938|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667939|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667940|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667941|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667942|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667943|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667944|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667945|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667946|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667947|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667948|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667949|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667950|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667951|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667952|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667953|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667954|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667955|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667956|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667957|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667958|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667959|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667960|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667961|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667962|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667963|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667964|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667965|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667966|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667967|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667968|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667969|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667970|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667971|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667972|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667973|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667974|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667975|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667976|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667977|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667978|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667979|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667980|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667981|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667982|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667983|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667984|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667985|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667986|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667987|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667988|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667989|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667990|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667991|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667992|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667993|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667994|NCT00359619|E7|Reported Event|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667995|NCT00359619|E6|Reported Event|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
668044|NCT00359281|P9|Participant Flow|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
667996|NCT00359619|E5|Reported Event|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667997|NCT00359619|E4|Reported Event|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667998|NCT00359619|E3|Reported Event|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
667999|NCT00359619|E2|Reported Event|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
668000|NCT00359619|E1|Reported Event|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
668001|NCT00359424|B3|Baseline|Total|Total of all reporting groups
668002|NCT00359424|B2|Baseline|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668003|NCT00359424|B1|Baseline|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668004|NCT00359424|P2|Participant Flow|IV Rt-PA Alone|IV rt-PA alone (group one) received the standard dose (.9mg per kilogram with 10% as a bolus and the remainder as an infusion over 1 hour -maximum dose 90mg) of intravenous (IV) rt-PA alone.
668005|NCT00359424|P1|Participant Flow|Endovascular Therapy|Endovascular therapy (group two) received a lower dose (0.09mg per kg bolus and 0.54mg/kilogram infusion over 40 minutes, maximum dose 53.6mg) or after Amendment #5, a standard dose of IV rt-PA (.9mg/kg with 10% as a bolus and the remainder over one hour) and then underwent an angiogram test (cerebral angiography) right after the medicine was given to check for blood clots. If a clot was not seen, then no more treatment was given. If a clot was seen, the neurointerventionalist chose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that would be most effective in reopening the blocked artery.
668006|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668007|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668008|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668009|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668010|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668011|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668012|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668013|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668014|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668015|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668016|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668017|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668018|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668019|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668020|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668021|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668022|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668023|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668024|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668025|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668026|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668027|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668028|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668029|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668030|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668031|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
668032|NCT00359424|E2|Reported Event|IV Only|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
668033|NCT00359424|E1|Reported Event|Endovascular|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) rightafter the medicine is given to check for blood clots. If a clot is not seenthen no more treatment will be given. If a clot is seen, theneurointerventionalist will then choose (based on the location andextent of the blood clot) a protocol approved endovascular treatmentgiven directly in the brain artery that will be most effective inreopening the blocked artery.
668034|NCT00359281|B10|Baseline|Total|Total of all reporting groups
668035|NCT00359281|B9|Baseline|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
668036|NCT00359281|B8|Baseline|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
668037|NCT00359281|B7|Baseline|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
668038|NCT00359281|B6|Baseline|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
668039|NCT00359281|B5|Baseline|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
668040|NCT00359281|B4|Baseline|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
668041|NCT00359281|B3|Baseline|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
668042|NCT00359281|B2|Baseline|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
668043|NCT00359281|B1|Baseline|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
668115|NCT00359073|P2|Participant Flow|Placebo|subjects received placebo, once per day
668045|NCT00359281|P8|Participant Flow|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
668046|NCT00359281|P7|Participant Flow|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
668047|NCT00359281|P6|Participant Flow|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
668048|NCT00359281|P5|Participant Flow|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
668049|NCT00359281|P4|Participant Flow|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
668050|NCT00359281|P3|Participant Flow|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
668051|NCT00359281|P2|Participant Flow|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
668052|NCT00359281|P1|Participant Flow|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
668053|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
668054|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
668055|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
668056|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
668057|NCT00359281|O1|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
668058|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
668059|NCT00359281|O1|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
668060|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
668061|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
668062|NCT00359281|O9|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
668063|NCT00359281|O8|Outcome|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
668064|NCT00359281|O7|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
668065|NCT00359281|O6|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
668066|NCT00359281|O5|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
668067|NCT00359281|O4|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
668068|NCT00359281|O3|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
668069|NCT00359281|O2|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
668070|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
668071|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
668072|NCT00359281|E9|Reported Event|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
668073|NCT00359281|E8|Reported Event|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
668074|NCT00359281|E7|Reported Event|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
668075|NCT00359281|E6|Reported Event|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
668076|NCT00359281|E5|Reported Event|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
668077|NCT00359281|E4|Reported Event|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
668078|NCT00359281|E3|Reported Event|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
668079|NCT00359281|E2|Reported Event|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
668080|NCT00359281|E1|Reported Event|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
668081|NCT00359216|B3|Baseline|Total|Total of all reporting groups
668082|NCT00359216|B2|Baseline|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
668083|NCT00359216|B1|Baseline|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
668084|NCT00359216|P2|Participant Flow|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
668085|NCT00359216|P1|Participant Flow|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
668086|NCT00359216|O2|Outcome|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
668087|NCT00359216|O1|Outcome|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
668088|NCT00359216|E2|Reported Event|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
668089|NCT00359216|E1|Reported Event|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
668090|NCT00359203|B3|Baseline|Total|Total of all reporting groups
668091|NCT00359203|B2|Baseline|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
668092|NCT00359203|B1|Baseline|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
668093|NCT00359203|P2|Participant Flow|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
668094|NCT00359203|P1|Participant Flow|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
668095|NCT00359203|O2|Outcome|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
668096|NCT00359203|O1|Outcome|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
668097|NCT00359203|E2|Reported Event|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
668098|NCT00359203|E1|Reported Event|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
668099|NCT00359138|B4|Baseline|Total|Total of all reporting groups
668100|NCT00359138|B3|Baseline|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668101|NCT00359138|B2|Baseline|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668102|NCT00359138|B1|Baseline|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668103|NCT00359138|P3|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668104|NCT00359138|P2|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668105|NCT00359138|P1|Participant Flow|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668106|NCT00359138|O3|Outcome|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668107|NCT00359138|O2|Outcome|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668108|NCT00359138|O1|Outcome|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668109|NCT00359138|E3|Reported Event|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668110|NCT00359138|E2|Reported Event|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668111|NCT00359138|E1|Reported Event|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
668112|NCT00359073|B3|Baseline|Total|Total of all reporting groups
668113|NCT00359073|B2|Baseline|Placebo|subjects received placebo, once per day
668114|NCT00359073|B1|Baseline|Montelukast|subjects received study drug montelukast, 10 mg once per day
668117|NCT00359073|O2|Outcome|Placebo|subjects received placebo, once per day
668118|NCT00359073|O1|Outcome|Montelukast|subjects received study drug montelukast, 10 mg once per day
668119|NCT00359073|O2|Outcome|Placebo|"Placebo comparator~placebo: like placebo"
668120|NCT00359073|O1|Outcome|Montelukast|"montelukast (10 mg everyday)~montelukast: 10 mg everyday"
668121|NCT00359073|O2|Outcome|Placebo|subjects received placebo, once per day
668122|NCT00359073|O1|Outcome|Montelukast|subjects received study drug montelukast, 10 mg once per day
668123|NCT00359073|E2|Reported Event|Placebo|subjects received placebo, once per day
668124|NCT00359073|E1|Reported Event|Montelukast|subjects received study drug montelukast, 10 mg once per day
668125|NCT00359021|B3|Baseline|Total|Total of all reporting groups
668126|NCT00359021|B2|Baseline|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
668127|NCT00359021|B1|Baseline|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
668128|NCT00359021|P2|Participant Flow|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
668129|NCT00359021|P1|Participant Flow|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
668130|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
668131|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
668132|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
668133|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
668134|NCT00359021|O3|Outcome|All Participants|DUET Placebo + DUET TMC125
668135|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
668136|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
668137|NCT00359021|E3|Reported Event|All Participants|Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).
668138|NCT00359021|E2|Reported Event|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
668139|NCT00359021|E1|Reported Event|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
668140|NCT00358956|B1|Baseline|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668141|NCT00358956|P1|Participant Flow|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668142|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668143|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668144|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668145|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668146|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668147|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668148|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668149|NCT00358956|E1|Reported Event|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
668150|NCT00358917|B3|Baseline|Total|Total of all reporting groups
668151|NCT00358917|B2|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
668152|NCT00358917|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
668153|NCT00358917|P2|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet
668154|NCT00358917|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet
668155|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
668156|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
668157|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet; 81% NNRTI-experienced, 45% PI-experienced (20% nelfinavir, 17% indinavir, 13% atazanavir).
668158|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet; 88% NNRTI-experienced, 47% PI-experienced (24% nelfinavir, 19% indinavir, 13% atazanavir).
668159|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
668160|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
668161|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
668162|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
668163|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
668164|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
668165|NCT00358917|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
668166|NCT00358917|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
668167|NCT00358826|B5|Baseline|Total|Total of all reporting groups
668168|NCT00358826|B4|Baseline|Placebo|Matching Placebo, oral dosing, 12 weeks
668169|NCT00358826|B3|Baseline|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668170|NCT00358826|B2|Baseline|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668171|NCT00358826|B1|Baseline|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668172|NCT00358826|P8|Participant Flow|Placebo MDCT Substudy|Matching Placebo, 24 weeks
668173|NCT00358826|P7|Participant Flow|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
668174|NCT00358826|P6|Participant Flow|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
668175|NCT00358826|P5|Participant Flow|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
668176|NCT00358826|P4|Participant Flow|Placebo|Matching Placebo, 12 weeks
668177|NCT00358826|P3|Participant Flow|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668178|NCT00358826|P2|Participant Flow|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668179|NCT00358826|P1|Participant Flow|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668180|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
668181|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668182|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668183|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668184|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
668185|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668186|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668187|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668188|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
668189|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
668190|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
668191|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
668192|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
668193|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
668194|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
668195|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
668196|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
668197|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668198|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668199|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668200|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
668201|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668202|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668203|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668204|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
668205|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668206|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668207|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668208|NCT00358826|E4|Reported Event|Placebo|Matching Placebo, oral dosing, 12 weeks
668209|NCT00358826|E3|Reported Event|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
668210|NCT00358826|E2|Reported Event|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
668211|NCT00358826|E1|Reported Event|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
668212|NCT00358735|B3|Baseline|Total|Total of all reporting groups
668213|NCT00358735|B2|Baseline|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668214|NCT00358735|B1|Baseline|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668215|NCT00358735|P2|Participant Flow|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668216|NCT00358735|P1|Participant Flow|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668217|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668218|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668219|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668220|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668221|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668222|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668223|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668224|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668225|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668226|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668227|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668228|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668229|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668230|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668231|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668232|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668233|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668234|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668235|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668236|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668237|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668238|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668239|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668240|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668749|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
668241|NCT00358735|E2|Reported Event|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
668242|NCT00358735|E1|Reported Event|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
668243|NCT00358670|B3|Baseline|Total|Total of all reporting groups
668244|NCT00358670|B2|Baseline|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
668245|NCT00358670|B1|Baseline|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
668246|NCT00358670|P2|Participant Flow|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 (NCT00251641) Baseline
668247|NCT00358670|P1|Participant Flow|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
668248|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
668249|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
668250|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
668251|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
668252|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
668253|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
668254|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
668255|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
668256|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
668257|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
668258|NCT00358670|E2|Reported Event|Intermittent Infliximab|
668259|NCT00358670|E1|Reported Event|Maintenance Infliximab|
668260|NCT00358644|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
668261|NCT00358644|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
668262|NCT00358644|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
668263|NCT00358644|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
668264|NCT00358579|B3|Baseline|Total|Total of all reporting groups
668265|NCT00358579|B2|Baseline|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668266|NCT00358579|B1|Baseline|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668267|NCT00358579|P2|Participant Flow|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668268|NCT00358579|P1|Participant Flow|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668269|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668270|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668271|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668272|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668273|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668274|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668275|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668276|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668277|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668278|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668279|NCT00358579|E2|Reported Event|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668280|NCT00358579|E1|Reported Event|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
668281|NCT00358527|B3|Baseline|Total|Total of all reporting groups
668282|NCT00358527|B2|Baseline|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
668283|NCT00358527|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
668284|NCT00358527|P2|Participant Flow|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
668285|NCT00358527|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
668286|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
668287|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
668288|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
668289|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
668290|NCT00358527|E2|Reported Event|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
668291|NCT00358527|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
668292|NCT00358501|B3|Baseline|Total|Total of all reporting groups
668293|NCT00358501|B2|Baseline|Historical Control|The control group was selected from the historical medical charts of patients undergoing hematopoietic stem cell transplant (HSCT).
668294|NCT00358501|B1|Baseline|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
668295|NCT00358501|P2|Participant Flow|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
668296|NCT00358501|P1|Participant Flow|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
668297|NCT00358501|O1|Outcome|Historical Control|
668298|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
668299|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
668300|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
668301|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
668302|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
668303|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
668304|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
668305|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
668306|NCT00358501|E2|Reported Event|Historical Control|
668307|NCT00358501|E1|Reported Event|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
668308|NCT00358462|B3|Baseline|Total|Total of all reporting groups
668309|NCT00358462|B2|Baseline|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
668310|NCT00358462|B1|Baseline|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
668311|NCT00358462|P2|Participant Flow|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
668312|NCT00358462|P1|Participant Flow|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
668313|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
668314|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
668315|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
668316|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
668317|NCT00358462|E2|Reported Event|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
668318|NCT00358462|E1|Reported Event|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
668319|NCT00358449|B4|Baseline|Total|Total of all reporting groups
668320|NCT00358449|B3|Baseline|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668321|NCT00358449|B2|Baseline|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668322|NCT00358449|B1|Baseline|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
668323|NCT00358449|P3|Participant Flow|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668324|NCT00358449|P2|Participant Flow|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668325|NCT00358449|P1|Participant Flow|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
668326|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668327|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668328|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668329|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668330|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668331|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668332|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668333|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668334|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668335|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668336|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668337|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668338|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668339|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668340|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668341|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668342|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668343|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668344|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668345|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668346|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668347|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668348|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668349|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668350|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668351|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668352|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668353|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668354|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668355|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668356|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668357|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668358|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668359|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668360|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668361|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668362|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668363|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668364|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668365|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668366|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668367|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668368|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668369|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668370|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668371|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668372|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668863|NCT00357110|B1|Baseline|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
668373|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668374|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668375|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668376|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668377|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668378|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668379|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668380|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668381|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668382|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668383|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668384|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668385|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668386|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668387|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668388|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668389|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668390|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668391|NCT00358449|O1|Outcome|Mepolizumab 0.55/ 2.5/ 10 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668392|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668393|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668394|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668395|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668396|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668397|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668398|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668399|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668400|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668401|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668402|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668403|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668404|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668405|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668406|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668407|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668408|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668409|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668410|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668411|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668412|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668413|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668414|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668415|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668416|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668864|NCT00357110|P2|Participant Flow|Anastrozole|anastrozole 1 mg
668417|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668418|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668419|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668420|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668421|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
668422|NCT00358449|E3|Reported Event|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668423|NCT00358449|E2|Reported Event|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
668424|NCT00358449|E1|Reported Event|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
668425|NCT00358436|B3|Baseline|Total|Total of all reporting groups
668426|NCT00358436|B2|Baseline|Placebo|Placebo by inhalation
668427|NCT00358436|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
668428|NCT00358436|P2|Participant Flow|Placebo|Placebo by inhalation
668429|NCT00358436|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
668430|NCT00358436|O2|Outcome|Placebo|Once daily administered via inhalation
668431|NCT00358436|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
668432|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
668433|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
668434|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
668435|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
668436|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
668437|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
668438|NCT00358436|E2|Reported Event|Placebo|Placebo by inhalation
668439|NCT00358436|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
668440|NCT00358332|B5|Baseline|Total|Total of all reporting groups
668441|NCT00358332|B4|Baseline|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668442|NCT00358332|B3|Baseline|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668443|NCT00358332|B2|Baseline|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668444|NCT00358332|B1|Baseline|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668445|NCT00358332|P4|Participant Flow|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668446|NCT00358332|P3|Participant Flow|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668447|NCT00358332|P2|Participant Flow|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668448|NCT00358332|P1|Participant Flow|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668449|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668450|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668451|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668452|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668453|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668454|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668455|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668456|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668457|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668458|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668750|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
668459|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668460|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668461|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668462|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668463|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668464|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668465|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668466|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668467|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668468|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668469|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668470|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668471|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668472|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668473|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668474|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668475|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668476|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668477|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668478|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668479|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668480|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668481|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668482|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668483|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668484|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668485|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668486|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668487|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668488|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668489|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668490|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668751|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
668491|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668492|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668493|NCT00358332|E4|Reported Event|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
668494|NCT00358332|E3|Reported Event|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668495|NCT00358332|E2|Reported Event|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668496|NCT00358332|E1|Reported Event|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
668497|NCT00358215|B3|Baseline|Total|Total of all reporting groups
668498|NCT00358215|B2|Baseline|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668499|NCT00358215|B1|Baseline|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668500|NCT00358215|P2|Participant Flow|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668501|NCT00358215|P1|Participant Flow|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668502|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668503|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668504|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668505|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668506|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668507|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668508|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668509|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668510|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668511|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668512|NCT00358215|E2|Reported Event|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
668513|NCT00358215|E1|Reported Event|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
668514|NCT00358150|B1|Baseline|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668515|NCT00358150|P1|Participant Flow|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 milligram (mg) dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 nanogram per milliliter [ng/mL] on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme), and if all other causes for lack of treatment effect had been evaluated and ruled out).
668516|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668517|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668518|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 8. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668519|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668520|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668521|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668522|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668523|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668524|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668525|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668526|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668527|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668528|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668529|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668530|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668531|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668532|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
668533|NCT00358150|E3|Reported Event|Eliglustat|Participants who received eliglustat capsule as a single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID or eliglustat 100 mg BID from Day 20 to Year 9. Participants who discontinued prior to Day 20 dose had their dose group set to missing and are only included in the all participants group. The Eliglustat group contains all participants who were treated with Eliglustat, including 2 participants dosed with 50 mg QD and 1 participant dosed with 150 mg BID for majority of study. Participants who had dose adjustment will be presented in dose group they received for majority of study.
668534|NCT00358150|E2|Reported Event|Eliglustat 100 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg capsule BID from Day 2 to Day 19 and then eliglustat 100 mg capsule BID from Day 20 to Year 9.
668535|NCT00358150|E1|Reported Event|Eliglustat 50 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg BID from Day 2 to Year 9.
668536|NCT00358007|B1|Baseline|Cone Beam CT|Undergo a cone beam CT scan
668537|NCT00358007|P1|Participant Flow|Cone Beam CT|Undergo a cone beam CT scan
668538|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
668539|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
668540|NCT00358007|E1|Reported Event|Cone Beam CT|Undergo a cone beam CT scan
668541|NCT00357994|B3|Baseline|Total|Total of all reporting groups
668542|NCT00357994|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668543|NCT00357994|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668544|NCT00357994|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668545|NCT00357994|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668546|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668547|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668548|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668549|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668550|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668551|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668552|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668553|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668554|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668555|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668556|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668557|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668558|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668559|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668560|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668561|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668562|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668563|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668564|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668565|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668566|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668567|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668568|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668569|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668570|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668571|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668572|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668573|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668574|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668575|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668576|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668577|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668578|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668579|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668580|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668581|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668582|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668583|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668584|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668585|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668586|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668587|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668588|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668589|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668590|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668591|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668592|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668593|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668594|NCT00357994|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
668595|NCT00357994|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
668596|NCT00357968|B3|Baseline|Total|Total of all reporting groups
668668|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668951|NCT00356915|O2|Outcome|Placebo Tablets|
668597|NCT00357968|B2|Baseline|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for 14 days. Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
668598|NCT00357968|B1|Baseline|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days. Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
668599|NCT00357968|P2|Participant Flow|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
668600|NCT00357968|P1|Participant Flow|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
668601|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
668602|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
668603|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
668604|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668605|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
668606|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
668607|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668608|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668609|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (52 from the first maintenance dose period and 51 from the second maintenance dose period).
668610|NCT00357968|O1|Outcome|Prasugrel|Includes the total number of evaluable samples from patients who received prasugrel in each maintenance dose period (50 from the first maintenance dose period and 50 from the second maintenance dose period)
668611|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
668612|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
668613|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
668614|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose
668615|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
668616|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668617|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
668752|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
668618|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
668619|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
668620|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
668621|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
668622|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668623|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) for the next 14 days.
668624|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for the next 14 days.
668625|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
668626|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
668627|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
668628|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
668629|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
668630|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
668631|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668632|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668633|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (46 from the first maintenance dose period and 40 from the second maintenance dose period).
668634|NCT00357968|O1|Outcome|Prasugrel|Includes total number of evaluable samples from patients who received prasugrel in each maintenance dose period (40 in the first maintenance period and 45 in the second maintenance period).
668635|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
668636|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
668637|NCT00357968|E4|Reported Event|Clopidogrel After Cross-over|Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
668669|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668753|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of rAHF-PFM
668638|NCT00357968|E3|Reported Event|Prasugrel After Cross-over|Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days
668639|NCT00357968|E2|Reported Event|Clopidogrel Before Cross-over|One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days.
668640|NCT00357968|E1|Reported Event|Prasugrel Before Cross-over|One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
668641|NCT00357955|B3|Baseline|Total|Total of all reporting groups
668642|NCT00357955|B2|Baseline|Usual Care|usual care
668643|NCT00357955|B1|Baseline|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
668644|NCT00357955|P2|Participant Flow|Usual Care|usual care
668645|NCT00357955|P1|Participant Flow|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
668646|NCT00357955|O2|Outcome|Usual Care|The standard of care to patients with type 2 diabetes is provided by primary care providers at the VA Medical Center through individual clinic visits. The frequency of these visits for patients with diabetes averages approximately 4 months.usual care
668647|NCT00357955|O1|Outcome|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
668648|NCT00357955|E2|Reported Event|Usual Care|usual care
668649|NCT00357955|E1|Reported Event|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
668650|NCT00357903|B3|Baseline|Total|Total of all reporting groups
668651|NCT00357903|B2|Baseline|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668652|NCT00357903|B1|Baseline|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668653|NCT00357903|P2|Participant Flow|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668654|NCT00357903|P1|Participant Flow|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668655|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668656|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668657|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668658|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668659|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668660|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668661|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668662|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668663|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668664|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668665|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668666|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668667|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668754|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of rAHF-PFM
668670|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668671|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668672|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668673|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668674|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668675|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668676|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668677|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668678|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668679|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668680|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668681|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668682|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668683|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668684|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668685|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668686|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668687|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
668688|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
668689|NCT00357903|E2|Reported Event|Pediatric Subjects|
668690|NCT00357903|E1|Reported Event|Total Adults|
668691|NCT00357877|B3|Baseline|Total|Total of all reporting groups
668692|NCT00357877|B2|Baseline|Active Dental Coating|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
668693|NCT00357877|B1|Baseline|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
668694|NCT00357877|P2|Participant Flow|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
668695|NCT00357877|P1|Participant Flow|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
668696|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
668697|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
668698|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
668699|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
668700|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
668701|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
668702|NCT00357877|O2|Outcome|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
668703|NCT00357877|O1|Outcome|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
668704|NCT00357877|E2|Reported Event|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
668705|NCT00357877|E1|Reported Event|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
668706|NCT00357760|B3|Baseline|Total|Total of all reporting groups
668707|NCT00357760|B2|Baseline|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
668708|NCT00357760|B1|Baseline|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
668709|NCT00357760|P2|Participant Flow|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
668710|NCT00357760|P1|Participant Flow|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
668711|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
668712|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
668713|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
668714|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
668715|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
668716|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
668717|NCT00357760|E2|Reported Event|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
668718|NCT00357760|E1|Reported Event|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
668719|NCT00357734|B1|Baseline|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668720|NCT00357734|P1|Participant Flow|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668721|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668722|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668723|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668724|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668725|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668726|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668727|NCT00357734|E1|Reported Event|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
668728|NCT00357656|B3|Baseline|Total|Total of all reporting groups
668729|NCT00357656|B2|Baseline|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668730|NCT00357656|B1|Baseline|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668731|NCT00357656|P2|Participant Flow|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668732|NCT00357656|P1|Participant Flow|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668733|NCT00357656|O3|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose
668734|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668735|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668736|NCT00357656|O3|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose.
668737|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668738|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668739|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
668740|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
668741|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
668742|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
668743|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
668744|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
668745|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668746|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668747|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
668748|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
668755|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
668756|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
668757|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
668758|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
668759|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
668760|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
668761|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668762|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668763|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
668764|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
668765|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
668766|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
668767|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
668768|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
668769|NCT00357656|O2|Outcome|Contiuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668770|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668771|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
668772|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
668773|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
668774|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
668775|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
668776|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
668777|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
668778|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
668779|NCT00357656|E3|Reported Event|Not Assigned Participants|All participants who were not assigned to either bolus infusion or continuous infusion but received at least one ADVATE (rAHF-PFM) dose during pharmacokinetic evaluation. A total of 9 participants received only the pharmacokinetic infusion and were not randomized.
668780|NCT00357656|E2|Reported Event|Continuous Infusion|All participants who were randomized to receive continuous infusion (CI) of ADVATE (rAHF-PFM). At total of 32 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
668781|NCT00357656|E1|Reported Event|Bolus Infusion|All participants who were randomized to receive bolus infusion (BI) of ADVATE (rAHF-PFM). At total of 31 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
668782|NCT00357552|B1|Baseline|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668783|NCT00357552|P1|Participant Flow|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668784|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668785|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668786|NCT00357552|O1|Outcome|LPV/r Monotherapy|"Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once a day will be added to their regimen.~Emtricitabine/Tenofovir disoproxil fumarate: Once daily~Lopinavir/Ritonavir: Twice daily"
668787|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668788|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668789|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen. The study is ongoing. Results from entry to week 24 are posted. They will be updated upon completion of study duration of 104 weeks.
668790|NCT00357552|O1|Outcome|Virologic Failures by Week 24.|Subjects who met virologic failure criteria by week 24, for whom a sequence could be obtained.
668791|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668792|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668793|NCT00357552|O1|Outcome|All Screened Subjects With Available Sequences|All screened individuals, for whom a sequence could be obtained, regardless of whether they enrolled or not.
668794|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668795|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668796|NCT00357552|E1|Reported Event|LPV/r|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
668797|NCT00357500|B1|Baseline|5-drug Metronmic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
668798|NCT00357500|P1|Participant Flow|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
668799|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
668800|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
668801|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
668802|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
668803|NCT00357500|E1|Reported Event|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
668804|NCT00357396|B3|Baseline|Total|Total of all reporting groups
668861|NCT00357110|B3|Baseline|Total|Total of all reporting groups
668805|NCT00357396|B2|Baseline|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
668806|NCT00357396|B1|Baseline|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
668807|NCT00357396|P2|Participant Flow|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
668808|NCT00357396|P1|Participant Flow|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
668809|NCT00357396|O1|Outcome|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
668810|NCT00357396|E2|Reported Event|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
668811|NCT00357396|E1|Reported Event|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
668812|NCT00357370|B4|Baseline|Total|Total of all reporting groups
668813|NCT00357370|B3|Baseline|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668814|NCT00357370|B2|Baseline|Placebo|Tablets, oral, once daily for 12 weeks
668815|NCT00357370|B1|Baseline|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668816|NCT00357370|P3|Participant Flow|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668817|NCT00357370|P2|Participant Flow|Placebo|Tablets, oral, once daily for 12 weeks
668818|NCT00357370|P1|Participant Flow|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668819|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668820|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668821|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
668822|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668823|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668824|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
668825|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668826|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668827|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
668828|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668829|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668830|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
668831|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668832|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668833|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
668834|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668835|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668836|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
668837|NCT00357370|E3|Reported Event|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
668838|NCT00357370|E2|Reported Event|Placebo|Tablets, oral, once daily for 12 weeks
668839|NCT00357370|E1|Reported Event|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
668840|NCT00357331|B3|Baseline|Total|Total of all reporting groups
668841|NCT00357331|B2|Baseline|Potassium Citrate|
668842|NCT00357331|B1|Baseline|Placebo|
668843|NCT00357331|P2|Participant Flow|Placebo|"Placebo~Placebo 20 meq by mouth in capsule form twice daily"
668844|NCT00357331|P1|Participant Flow|Potassium Citrate|"Potassium Citrate 20 meq twice daily~potassium citrate: 20 meq by mouth in capsule form twice daily"
668845|NCT00357331|O2|Outcome|Potassium Citrate|
668846|NCT00357331|O1|Outcome|Placebo|
668847|NCT00357331|O2|Outcome|Potassium Citrate|
668848|NCT00357331|O1|Outcome|Placebo|
668849|NCT00357331|O2|Outcome|Potassium Citrate|
668850|NCT00357331|O1|Outcome|Placebo|
668851|NCT00357331|E2|Reported Event|Placebo|"Placebo~potassium citrate: 20 meq by mouth in capsule form twice daily"
668852|NCT00357331|E1|Reported Event|Potassium Citrate|"Potassium Citrate 20 meq twice daily~potassium citrate: 20 meq by mouth in capsule form twice daily"
668853|NCT00357162|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668854|NCT00357162|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668855|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668856|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668857|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668858|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668859|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668860|NCT00357162|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
668865|NCT00357110|P1|Participant Flow|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
668866|NCT00357110|O2|Outcome|Anastrozole|anastrozole 1 mg
668867|NCT00357110|O1|Outcome|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
668868|NCT00357110|E2|Reported Event|Anastrozole|anastrozole 1 mg
668869|NCT00357110|E1|Reported Event|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
668870|NCT00357097|B3|Baseline|Total|Total of all reporting groups
668871|NCT00357097|B2|Baseline|Placebo|Subjects who took no investigational product.
668872|NCT00357097|B1|Baseline|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668873|NCT00357097|P2|Participant Flow|Placebo|Subjects who took no investigational product.
668874|NCT00357097|P1|Participant Flow|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668875|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668876|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668877|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668878|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668879|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668880|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668881|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668882|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668883|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668884|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668885|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668886|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668887|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668888|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668889|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668890|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668891|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668892|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668893|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668894|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668895|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668896|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668897|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668898|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668899|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668900|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668901|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668902|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668903|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668904|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668905|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668906|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668907|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668952|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
668908|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668909|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668910|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668911|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668912|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668913|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
668914|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668915|NCT00357097|E2|Reported Event|Placebo|Subjects who took no investigational product.
668916|NCT00357097|E1|Reported Event|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
668917|NCT00357032|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
668918|NCT00357032|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
668919|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
668920|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
668921|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
668922|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
668923|NCT00357032|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
668924|NCT00357006|B4|Baseline|Total|Total of all reporting groups
668925|NCT00357006|B3|Baseline|Placebo|
668926|NCT00357006|B2|Baseline|Adjunctive 100 mcg Transdermal Estradiol|
668927|NCT00357006|B1|Baseline|Adjunctive 200 mcg Transdermal Estradiol|
668928|NCT00357006|P3|Participant Flow|Placebo|Participants received daily transdermal placebo for 56 days.
668929|NCT00357006|P2|Participant Flow|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 56 days.
668930|NCT00357006|P1|Participant Flow|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 56 days.
668931|NCT00357006|O3|Outcome|Placebo|Participants received daily transdermal placebo for 56 days.
668932|NCT00357006|O2|Outcome|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100 mcg transdermal estradiol for 56 days.
668933|NCT00357006|O1|Outcome|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200 mcg transdermal estradiol for 56 days.
668934|NCT00357006|E3|Reported Event|Placebo|Participants received daily transdermal placebo for 8 weeks (56 days).
668935|NCT00357006|E2|Reported Event|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 8 weeks (56 days).
668936|NCT00357006|E1|Reported Event|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 8 weeks (56 days).
668937|NCT00356915|B4|Baseline|Total|Total of all reporting groups
668938|NCT00356915|B3|Baseline|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
668939|NCT00356915|B2|Baseline|Itraconazole Capsules|Itraconazole 100 mg capsules
668940|NCT00356915|B1|Baseline|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
668941|NCT00356915|P3|Participant Flow|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
668942|NCT00356915|P2|Participant Flow|Itraconazole Capsules|Itraconazole 100 mg capsules
668943|NCT00356915|P1|Participant Flow|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
668944|NCT00356915|O2|Outcome|Placebo Tablets|
668945|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
668946|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100mg capsules
668947|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
668948|NCT00356915|O3|Outcome|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
668949|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100 mg capsules
668950|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
668953|NCT00356915|E6|Reported Event|Placebo Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
668954|NCT00356915|E5|Reported Event|Itraconazole Capsules - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
668955|NCT00356915|E4|Reported Event|Itraconazole Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
668956|NCT00356915|E3|Reported Event|Placebo Tablets|Adverse events that occurred during the Treatment Period are reported here.
668957|NCT00356915|E2|Reported Event|Itraconazole Capsules|Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.
668958|NCT00356915|E1|Reported Event|Itraconazole Tablets - Treatment Period|Itraconazole 200mg tablets Adverse events that occurred during the Treatment Period are reported here.
668959|NCT00356889|B1|Baseline|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
668960|NCT00356889|P1|Participant Flow|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
668961|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
668962|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
668963|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
668964|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
668965|NCT00356889|E1|Reported Event|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
668966|NCT00356863|B3|Baseline|Total|Total of all reporting groups
668967|NCT00356863|B2|Baseline|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668968|NCT00356863|B1|Baseline|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668969|NCT00356863|P2|Participant Flow|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668970|NCT00356863|P1|Participant Flow|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668971|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668972|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
669250|NCT00356187|O1|Outcome|Propranol Treatment|Propranolol
669251|NCT00356187|O2|Outcome|Standard of Care|
668973|NCT00356863|O2|Outcome|No Education (Control) About Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668974|NCT00356863|O1|Outcome|Educational (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668975|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668976|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668977|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668978|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668979|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668980|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668981|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668982|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668983|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668984|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668985|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668986|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668987|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668988|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668989|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668990|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668991|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about CR and were giving the usual care.
668992|NCT00356863|O1|Outcome|Education (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668993|NCT00356863|E2|Reported Event|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
668994|NCT00356863|E1|Reported Event|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
668995|NCT00356811|B1|Baseline|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
668996|NCT00356811|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
668997|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
668998|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
668999|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669000|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669001|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669002|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669003|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669004|NCT00356811|O1|Outcome|Overall Study Arm|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669005|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669006|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669007|NCT00356811|E1|Reported Event|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
669008|NCT00356603|B3|Baseline|Total|Total of all reporting groups
669009|NCT00356603|B2|Baseline|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669010|NCT00356603|B1|Baseline|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669011|NCT00356603|P2|Participant Flow|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669012|NCT00356603|P1|Participant Flow|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 milligrams (mg) kit product (0.5 milliliter [mL] containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669013|NCT00356603|O3|Outcome|Migraine + Cluster Headache|Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669014|NCT00356603|O2|Outcome|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669015|NCT00356603|O1|Outcome|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669016|NCT00356603|O3|Outcome|Migraine + Cluster Headache|Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669017|NCT00356603|O2|Outcome|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669018|NCT00356603|O1|Outcome|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669019|NCT00356603|O3|Outcome|Migraine + Cluster Headache|Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669020|NCT00356603|O2|Outcome|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669021|NCT00356603|O1|Outcome|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669022|NCT00356603|E3|Reported Event|Migraine + Cluster Headache|Participants with migraine and cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669023|NCT00356603|E2|Reported Event|Cluster Headache|Participants with cluster headache administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669024|NCT00356603|E1|Reported Event|Migraine|Participants with migraine administered one subcutaneous dose of Sumatriptan Succinate Injection 3 mg kit product (0.5 mL containing 4.2 mg of sumatriptan succinate) by self-injection. The recommended injection site was the thigh.
669025|NCT00356590|B1|Baseline|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669026|NCT00356590|P1|Participant Flow|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669027|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669028|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669029|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669030|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669031|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669032|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669033|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669034|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669035|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669036|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669037|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669038|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669039|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669040|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669041|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669042|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669043|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669044|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669045|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669046|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669047|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669048|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669049|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669050|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669051|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669052|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669053|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669054|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669055|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
669056|NCT00356590|E1|Reported Event|Enbrel|
669057|NCT00356525|B5|Baseline|Total|Total of all reporting groups
669058|NCT00356525|B4|Baseline|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669059|NCT00356525|B3|Baseline|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669252|NCT00356187|O1|Outcome|Propranol Treatment|Propranolol
669060|NCT00356525|B2|Baseline|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669061|NCT00356525|B1|Baseline|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669062|NCT00356525|P4|Participant Flow|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669063|NCT00356525|P3|Participant Flow|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669064|NCT00356525|P2|Participant Flow|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669065|NCT00356525|P1|Participant Flow|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669066|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669067|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669068|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669069|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669070|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669071|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669072|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669073|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669074|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669075|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669076|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669077|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669078|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669079|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669080|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669081|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669082|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669083|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669084|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669085|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669086|NCT00356525|E4|Reported Event|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669087|NCT00356525|E3|Reported Event|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
669088|NCT00356525|E2|Reported Event|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
669089|NCT00356525|E1|Reported Event|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
669090|NCT00356434|B3|Baseline|Total|Total of all reporting groups
669091|NCT00356434|B2|Baseline|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669092|NCT00356434|B1|Baseline|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669093|NCT00356434|P2|Participant Flow|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669094|NCT00356434|P1|Participant Flow|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669095|NCT00356434|O2|Outcome|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669096|NCT00356434|O1|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669097|NCT00356434|O2|Outcome|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669098|NCT00356434|O1|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent Deep Vein Thrombosis (DVT)~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669099|NCT00356434|O2|Outcome|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669100|NCT00356434|O1|Outcome|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669101|NCT00356434|E2|Reported Event|Sequential Compression Device|"Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT~Kendall sequential compression device, model 9525: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669102|NCT00356434|E1|Reported Event|Foot Pump|"Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT~Kendall A-V foot impulse pump, model 6060: Will wear device for DVT prevention and receive questionnaire about compliance and comfort. Will also undergo random checks to confirm compliance with instructions and use"
669103|NCT00356421|B3|Baseline|Total|Total of all reporting groups
669104|NCT00356421|B2|Baseline|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669105|NCT00356421|B1|Baseline|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669106|NCT00356421|P2|Participant Flow|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669107|NCT00356421|P1|Participant Flow|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669108|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669109|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669110|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669111|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669112|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669113|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669114|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669115|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669116|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669117|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669118|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669119|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669120|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669121|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669122|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669123|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669124|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669125|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669126|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669127|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669128|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669129|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669130|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669131|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669132|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669133|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669134|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669135|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669136|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669137|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669138|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669139|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669140|NCT00356421|E2|Reported Event|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
669141|NCT00356421|E1|Reported Event|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
669142|NCT00356408|B5|Baseline|Total|Total of all reporting groups
669143|NCT00356408|B4|Baseline|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669144|NCT00356408|B3|Baseline|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669145|NCT00356408|B2|Baseline|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
669146|NCT00356408|B1|Baseline|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
669147|NCT00356408|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
669148|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669149|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669150|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
669151|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
669152|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669153|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669154|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
669155|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
669156|NCT00356408|E5|Reported Event|CDP870 400 mg (Overall)|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
669157|NCT00356408|E4|Reported Event|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669158|NCT00356408|E3|Reported Event|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
669159|NCT00356408|E2|Reported Event|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
669160|NCT00356408|E1|Reported Event|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
669161|NCT00356304|B3|Baseline|Total|Total of all reporting groups
669162|NCT00356304|B2|Baseline|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
669163|NCT00356304|B1|Baseline|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
669164|NCT00356304|P2|Participant Flow|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
669165|NCT00356304|P1|Participant Flow|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
669166|NCT00356304|O2|Outcome|Treatment as Usual|
669167|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
669168|NCT00356304|O2|Outcome|Treatment as Usual|
669169|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
669170|NCT00356304|E2|Reported Event|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
669171|NCT00356304|E1|Reported Event|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
669172|NCT00356278|B4|Baseline|Total|Total of all reporting groups
669173|NCT00356278|B3|Baseline|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669174|NCT00356278|B2|Baseline|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669175|NCT00356278|B1|Baseline|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669258|NCT00356148|B2|Baseline|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
669176|NCT00356278|P3|Participant Flow|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669177|NCT00356278|P2|Participant Flow|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669178|NCT00356278|P1|Participant Flow|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669179|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669180|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669181|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669182|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669183|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669184|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669185|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669186|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669187|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669188|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669189|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669190|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669191|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669253|NCT00356187|O2|Outcome|Standard of Care|Results: 0 Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.
669254|NCT00356187|O1|Outcome|Propranol Treatment|Propranolol
669533|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
669192|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669193|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669194|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669195|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669196|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669197|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669198|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669199|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669200|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669201|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669202|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669203|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669204|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669205|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669206|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669207|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669255|NCT00356187|E2|Reported Event|Standard of Care|Results: 0 Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.
669256|NCT00356187|E1|Reported Event|Propranol Treatment|Propranolol
669208|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669209|NCT00356278|E3|Reported Event|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
669210|NCT00356278|E2|Reported Event|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669211|NCT00356278|E1|Reported Event|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
669212|NCT00356265|B4|Baseline|Total|Total of all reporting groups
669213|NCT00356265|B3|Baseline|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
669214|NCT00356265|B2|Baseline|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
669215|NCT00356265|B1|Baseline|Chronic Kidney Disease|Procedure: Regional phenylephrine arterial infusion
669216|NCT00356265|P3|Participant Flow|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
669217|NCT00356265|P2|Participant Flow|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
669218|NCT00356265|P1|Participant Flow|Chronic Kidney Disease (CKD)|Procedure: Regional phenylephrine arterial infusion
669219|NCT00356265|O3|Outcome|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
669220|NCT00356265|O2|Outcome|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
669221|NCT00356265|O1|Outcome|Chronic Kidney Disease|Procedure: Regional phenylephrine arterial infusion
669222|NCT00356265|O2|Outcome|Normotensive Group|
669223|NCT00356265|O1|Outcome|Chronic Kidney Disease|Procedure: Regional phenylephrine arterial infusion
669224|NCT00356265|E3|Reported Event|Normotensive Group|Procedure: Regional phenylephrine arterial infusion
669225|NCT00356265|E2|Reported Event|Hypertension Group|Procedure: Regional phenylephrine arterial infusion
669226|NCT00356265|E1|Reported Event|Chronic Kidney Disease|Procedure: Regional phenylephrine arterial infusion
669227|NCT00356200|B3|Baseline|Total|Total of all reporting groups
669228|NCT00356200|B2|Baseline|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
669229|NCT00356200|B1|Baseline|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
669230|NCT00356200|P2|Participant Flow|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
669231|NCT00356200|P1|Participant Flow|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
669232|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|Cohort 2 lesion treated with placebo
669233|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|Cohort 2 100 ug/ml Fluphenazine decanoate treated lesion
669234|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|Cohort 1 lesion treated with placebo
669235|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|Cohort 1 10 ug/ml Fluphenazine decanoate treated lesion
669236|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|lesion treated with placebo (Cohort 2)
669237|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
669238|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|lesion treated with placebo (Cohort 1)
669239|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
669240|NCT00356200|E2|Reported Event|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
669241|NCT00356200|E1|Reported Event|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
669242|NCT00356187|B3|Baseline|Total|Total of all reporting groups
669243|NCT00356187|B2|Baseline|Standard of Care|"Results: 0~Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data."
669244|NCT00356187|B1|Baseline|Propranol Treatment|Propranolol
669245|NCT00356187|P2|Participant Flow|Standard of Care|"Results: 0~Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data."
669246|NCT00356187|P1|Participant Flow|Propranol Treatment|Propranolol
669247|NCT00356187|O2|Outcome|Standard of Care|"Results: 0~Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data."
669248|NCT00356187|O1|Outcome|Propranol Treatment|Propranolol
669249|NCT00356187|O2|Outcome|Standard of Care|"Results: 0~Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data."
669259|NCT00356148|B1|Baseline|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
669260|NCT00356148|P2|Participant Flow|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
669261|NCT00356148|P1|Participant Flow|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
669262|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receiving antibiotic prophylaxis
669263|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
669264|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receive antibiotic prophylaxis
669265|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
669266|NCT00356148|E2|Reported Event|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
669267|NCT00356148|E1|Reported Event|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
669268|NCT00356135|B4|Baseline|Total|Total of all reporting groups
669269|NCT00356135|B3|Baseline|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669270|NCT00356135|B2|Baseline|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669271|NCT00356135|B1|Baseline|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669272|NCT00356135|P3|Participant Flow|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669273|NCT00356135|P2|Participant Flow|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669274|NCT00356135|P1|Participant Flow|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669275|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669276|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669277|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669278|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669279|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669280|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669281|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669282|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669283|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669284|NCT00356135|O2|Outcome|No Clopidogrel Use|Patients with no clopidogrel use at the time of qualifying ACS event.
669285|NCT00356135|O1|Outcome|Clopidogrel Use|Patients with clopidogrel use at the time of qualifying ACS event.
669286|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669287|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669288|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669289|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669290|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669291|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669292|NCT00356135|E3|Reported Event|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669293|NCT00356135|E2|Reported Event|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
669294|NCT00356135|E1|Reported Event|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
669295|NCT00356122|B1|Baseline|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669296|NCT00356122|P1|Participant Flow|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669297|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669298|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669299|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669300|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669301|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669302|NCT00356122|E1|Reported Event|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
669303|NCT00356057|B4|Baseline|Total|Total of all reporting groups
669304|NCT00356057|B3|Baseline|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
669305|NCT00356057|B2|Baseline|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
669306|NCT00356057|B1|Baseline|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
669307|NCT00356057|P3|Participant Flow|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
669308|NCT00356057|P2|Participant Flow|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
669309|NCT00356057|P1|Participant Flow|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
669310|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669311|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669312|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669313|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669314|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669534|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
669315|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669316|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669317|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669318|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669319|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669320|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669321|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669322|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669323|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669324|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with CLS rate adaptation (Protos CLS device)
669325|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669326|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669327|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669328|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669329|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669330|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669331|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669332|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669333|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669334|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669335|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669336|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669337|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669338|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
669339|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
669340|NCT00356057|O1|Outcome|Stratos LV System|Stratos LV (biV or RV pacing groups with accelerometer based rate adaptation)
669341|NCT00356057|O1|Outcome|Protos DR/CLS System|Protos DR/CLS (biV pacing with CLS rate adaptation)
669342|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
669343|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
669344|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
669345|NCT00356057|E1|Reported Event|All Groups|
669346|NCT00356031|B1|Baseline|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669396|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669397|NCT00355797|E3|Reported Event|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669535|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
669347|NCT00356031|P1|Participant Flow|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669348|NCT00356031|O1|Outcome|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669349|NCT00356031|O1|Outcome|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669350|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669351|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy."
669352|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669353|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669398|NCT00355797|E2|Reported Event|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669399|NCT00355797|E1|Reported Event|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669400|NCT00355784|B4|Baseline|Total|Total of all reporting groups
669401|NCT00355784|B3|Baseline|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone.
669354|NCT00356031|E1|Reported Event|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
669355|NCT00355914|B3|Baseline|Total|Total of all reporting groups
669356|NCT00355914|B2|Baseline|Group II With Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic with steroids
669357|NCT00355914|B1|Baseline|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
669358|NCT00355914|P2|Participant Flow|Group II With Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and Steroids (0.15 mg of non-particulate betamethasone)
669359|NCT00355914|P1|Participant Flow|Group 1 Without Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
669360|NCT00355914|O2|Outcome|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
669361|NCT00355914|O1|Outcome|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
669362|NCT00355914|O2|Outcome|Group II|Local anesthetic with steroids
669363|NCT00355914|O1|Outcome|Group I|Local anesthetic without steroids
669364|NCT00355914|E2|Reported Event|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
669365|NCT00355914|E1|Reported Event|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
669366|NCT00355797|B4|Baseline|Total|Total of all reporting groups
669367|NCT00355797|B3|Baseline|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669368|NCT00355797|B2|Baseline|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669369|NCT00355797|B1|Baseline|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669370|NCT00355797|P3|Participant Flow|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669371|NCT00355797|P2|Participant Flow|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669372|NCT00355797|P1|Participant Flow|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669373|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669374|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669375|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669376|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669377|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669378|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669379|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669380|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669381|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669382|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669383|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669384|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669385|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669386|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669387|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669388|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669389|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669390|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669391|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669392|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669393|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
669394|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
669395|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
669402|NCT00355784|B2|Baseline|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669403|NCT00355784|B1|Baseline|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669404|NCT00355784|P3|Participant Flow|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
669405|NCT00355784|P2|Participant Flow|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669406|NCT00355784|P1|Participant Flow|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669407|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
669408|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669409|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669410|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
669411|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669412|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669413|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
669414|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669415|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669416|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
669417|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669418|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669419|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
669420|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669447|NCT00355706|O1|Outcome|Group I Without Steroids|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
669448|NCT00355706|E2|Reported Event|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
669421|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669422|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
669423|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669424|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669425|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
669426|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669427|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669428|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
669429|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669430|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669431|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
669432|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669433|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669434|NCT00355784|E3|Reported Event|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
669435|NCT00355784|E2|Reported Event|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
669436|NCT00355784|E1|Reported Event|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
669437|NCT00355706|B3|Baseline|Total|Total of all reporting groups
669438|NCT00355706|B2|Baseline|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
669439|NCT00355706|B1|Baseline|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
669440|NCT00355706|P2|Participant Flow|Group II - With Steroids|Group II - Thoracic medial branch blocks with bupivacaine and steroid
669441|NCT00355706|P1|Participant Flow|Group I - Without Steroids|Group I - Thoracic medial branch blocks with local anesthetics
669442|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
669443|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
669444|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
669445|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
669446|NCT00355706|O2|Outcome|Group II With Steroid|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
669449|NCT00355706|E1|Reported Event|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
669450|NCT00355615|B5|Baseline|Total|Total of all reporting groups
669451|NCT00355615|B4|Baseline|Placebo|placebo
669452|NCT00355615|B3|Baseline|Rosuva 20|rosuvastatin 20 mg
669453|NCT00355615|B2|Baseline|Rosuva 10|rosuvastatin 10 mg
669454|NCT00355615|B1|Baseline|Rosuva 5|rosuvastatin 5 mg
669455|NCT00355615|P5|Participant Flow|Rosuva ol|rosuvastatin open label
669456|NCT00355615|P4|Participant Flow|Placebo|placebo
669457|NCT00355615|P3|Participant Flow|Rosuva 20|rosuvastatin 20 mg
669458|NCT00355615|P2|Participant Flow|Rosuva 10|rosuvastatin 10 mg
669459|NCT00355615|P1|Participant Flow|Rosuva 5|rosuvastatin 5 mg
669460|NCT00355615|O4|Outcome|Placebo|placebo
669461|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669462|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669463|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669464|NCT00355615|O4|Outcome|Placebo|placebo
669465|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669466|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669467|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669468|NCT00355615|O4|Outcome|Placebo|placebo
669469|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669470|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669471|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669472|NCT00355615|O4|Outcome|Placebo|placebo
669473|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669474|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669475|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669476|NCT00355615|O4|Outcome|Placebo|placebo
669477|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669478|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669479|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669480|NCT00355615|O4|Outcome|Placebo|placebo
669481|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669482|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669483|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669484|NCT00355615|O4|Outcome|Placebo|placebo
669485|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669486|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669487|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669488|NCT00355615|O4|Outcome|Placebo|placebo
669489|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669490|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669491|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669492|NCT00355615|O4|Outcome|Placebo|placebo
669493|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669494|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669495|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669496|NCT00355615|O4|Outcome|Placebo|placebo
669497|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669498|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669499|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669500|NCT00355615|O4|Outcome|Placebo|placebo
669501|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669502|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669503|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669504|NCT00355615|O4|Outcome|Placebo|placebo
669505|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669506|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669507|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669508|NCT00355615|O4|Outcome|Placebo|placebo
669509|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
669510|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
669511|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
669512|NCT00355615|E5|Reported Event|Rosuva ol|rosuvastatin open label
669513|NCT00355615|E4|Reported Event|Placebo|placebo
669514|NCT00355615|E3|Reported Event|Rosuva 20|rosuvastatin 20 mg
669515|NCT00355615|E2|Reported Event|Rosuva 10|rosuvastatin 10 mg
669516|NCT00355615|E1|Reported Event|Rosuva 5|rosuvastatin 5 mg
669517|NCT00355472|B1|Baseline|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
669518|NCT00355472|P1|Participant Flow|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CC chemokine 4 receptor (CCR4) positive Adult T-Cell Leukemia-Lymphoma (ATL) or CCR4 positive Peripheral T-Cell Lymphoma (PTCL)
669519|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL.
669520|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
669521|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
669522|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
669523|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
669524|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
669525|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
669526|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
669527|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
669528|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
669529|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
669530|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
669531|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
669532|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
669536|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
669537|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
669538|NCT00355472|E4|Reported Event|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
669539|NCT00355472|E3|Reported Event|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
669540|NCT00355472|E2|Reported Event|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
669541|NCT00355472|E1|Reported Event|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
669542|NCT00355394|B3|Baseline|Total|Total of all reporting groups
669543|NCT00355394|B2|Baseline|Metoclopramide|Metoclopramide group received standard care including IVF AND metoclopramide.
669544|NCT00355394|B1|Baseline|Placebo|Placebo group received standard care including IVF but not metoclopramide.
669545|NCT00355394|P2|Participant Flow|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
669546|NCT00355394|P1|Participant Flow|Placebo|Placebo group received standard care including IVF but not metoclopramide.
669547|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
669548|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
669549|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
669550|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
669551|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
669552|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
669553|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
669554|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
669555|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
669556|NCT00355394|O1|Outcome|Placebo|Placebo
669557|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
669558|NCT00355394|O1|Outcome|Placebo|Placebo
669559|NCT00355394|E2|Reported Event|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
669560|NCT00355394|E1|Reported Event|Placebo|Placebo group received standard care including IVF but not metoclopramide.
669561|NCT00355368|B3|Baseline|Total|Total of all reporting groups
669562|NCT00355368|B2|Baseline|Rocuronium|0.6mg/kg
669563|NCT00355368|B1|Baseline|Succinylcholine|1mg/kg
669564|NCT00355368|P2|Participant Flow|Rocuronium|0.6mg/kg
669565|NCT00355368|P1|Participant Flow|Succinylcholine|1mg/kg
669566|NCT00355368|O2|Outcome|Rocuronium|
669567|NCT00355368|O1|Outcome|Succinylcholine|
669568|NCT00355368|O2|Outcome|Rocuronium|
669569|NCT00355368|O1|Outcome|Succinylcholine|
669570|NCT00355368|O2|Outcome|Rocuronium|
669571|NCT00355368|O1|Outcome|Succinylcholine|
669572|NCT00355368|O2|Outcome|Rocuronium|
669573|NCT00355368|O1|Outcome|Succinylcholine|
669574|NCT00355368|E2|Reported Event|Rocuronium|0.6mg/kg
669575|NCT00355368|E1|Reported Event|Succinylcholine|1mg/kg
669576|NCT00355342|B3|Baseline|Total|Total of all reporting groups
669577|NCT00355342|B2|Baseline|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669578|NCT00355342|B1|Baseline|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669579|NCT00355342|P2|Participant Flow|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669580|NCT00355342|P1|Participant Flow|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.
669581|NCT00355342|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669582|NCT00355342|O1|Outcome|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669583|NCT00355342|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669584|NCT00355342|O1|Outcome|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669585|NCT00355342|E2|Reported Event|Fluticasone Propionate/Salmeterol 250/50 mcg BID|Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669586|NCT00355342|E1|Reported Event|Salmeterol 50 mcg BID|Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
669587|NCT00355199|B3|Baseline|Total|Total of all reporting groups
669588|NCT00355199|B2|Baseline|R-CHOP|"Rituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).~Rituximab-CHOP: Rituximab-CHOP"
669589|NCT00355199|B1|Baseline|R-HDS|"R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.~Rituximab-HDS: Rituximab-HDS"
669590|NCT00355199|P2|Participant Flow|R-CHOP 14|Patients enrolled into the control arm R-CHOP (rituximab 375 mg/m2 i.v., cyclophosphamide 750 mg/m2 i.v., doxorubicin 50 mg/m2 i.v., vincristine 1.4 mg/m2 i.v. given on day 1 and 100 mg/d of prednisone p.o. on days 1–5), given every 14 days x 8 cycles. The neutropenic phase was supported by G-CSF (filgrastrim 5μg/kg s.c. daily or Pegfilgrastim s.c. given once on day +1 of each cycle). CNS prophylaxis with intrathecal chemotherapy (MTX, ARAC, steroids) was given to high risk patients who, at diagnosis, had infiltration of the bone marrow, testes, Waldeyer ring, cranial air sinuses (including nasal), salivary glands and epidural space. In R-CHOP, 33 patients (27%) received intrathecal prophylaxis. Patients with initial bulky or residual lesions received IFRT within 2-3 months after chemotherapy program.
669591|NCT00355199|P1|Participant Flow|R-HDS|R-HDS: 3 APO: first Doxorubicin at 50 mg/m2 iv, then at 75 mg/m2 iv days 14, 28; Vincristine 1.4 mg/m2 iv days 1,14,28; Prednisone p.o 40 mg/m2 days1-28). Subsequently:high-dose (hd) Cyclophosphamide 7 g/m2 iv, day 1+ Rituximab 375 mg/m2 iv days +3;+11, harvest of peripheral blood progenitor cells (PBPC); hd-Cytarabine 2 g/m2 iv bid for 6 days. Day 7:infusion 1.5-2x10^6 autologous CD34+ cells/kg, Rituximab 375 mg/m2 iv day+8;+16; hd-Etoposide 2.4 g/m2 iv day +1, Cisplatin 100 mg/m2 iv day+2; PBPC (2x10^6 CD34+ cells/Kg) reinfused following etoposide/cisplatin. ASCT conditioned with mitoxantrone 60 mg/m2 iv day -5 and melphalan 180 mg/m2 iv day –2 or BEAM (BCNU 300 mg/m2 iv day -6, Etoposide 200 mg/m2 iv days -5 to –2, Ara-C 200 mg/m2 iv every 12 h x8 doses, days from -5 to -2, Melphalan 140 mg/m2 iv day-1),supported by PBPC autograft day 0. Two Rituximab days +14;+24 after ASCT. Patients with initial bulky or residual lesions received IFRT within 2-3 months after chemotherapy program.
669592|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
669593|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
669594|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
669595|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
669596|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
669597|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
669598|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
669599|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
669600|NCT00355199|O2|Outcome|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
669601|NCT00355199|O1|Outcome|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
669602|NCT00355199|E2|Reported Event|R-CHOP 14|Patients treated with R-CHOP-14 (8 cycles)
669603|NCT00355199|E1|Reported Event|R-HDS|Patients treated with high dose sequential chemotherapy program (R-HDS) with ASCT.
669604|NCT00355147|B3|Baseline|Total|Total of all reporting groups
669605|NCT00355147|B2|Baseline|Attention Control Group|Received Phone Calls from Staff to Control for Attention
669606|NCT00355147|B1|Baseline|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
669607|NCT00355147|P2|Participant Flow|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
669608|NCT00355147|P1|Participant Flow|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
669609|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
669610|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
669611|NCT00355147|O2|Outcome|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
669612|NCT00355147|O1|Outcome|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
669613|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
669614|NCT00355147|O1|Outcome|Arm 1 Secondary Risk Factor Management|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Stroke Self Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
669615|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
669616|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
669617|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
669618|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
669619|NCT00355147|E2|Reported Event|Attention Control Group|Received Phone Calls from Staff to Control for Attention
669620|NCT00355147|E1|Reported Event|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
669621|NCT00355134|B6|Baseline|Total|Total of all reporting groups
669622|NCT00355134|B5|Baseline|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
669623|NCT00355134|B4|Baseline|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669624|NCT00355134|B3|Baseline|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669625|NCT00355134|B2|Baseline|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669626|NCT00355134|B1|Baseline|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669627|NCT00355134|P5|Participant Flow|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
669628|NCT00355134|P4|Participant Flow|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669629|NCT00355134|P3|Participant Flow|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669630|NCT00355134|P2|Participant Flow|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669631|NCT00355134|P1|Participant Flow|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669632|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669633|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669634|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669635|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669636|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669637|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669638|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669639|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669640|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669641|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669642|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669643|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669644|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669645|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669646|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669647|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669648|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669649|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669650|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669651|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669652|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669653|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669654|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669655|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669656|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669657|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669658|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669659|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669660|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669661|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669662|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669663|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
669664|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669665|NCT00355134|E5|Reported Event|Extension: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day in the Extension phase.
669666|NCT00355134|E4|Reported Event|Extension: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669667|NCT00355134|E3|Reported Event|Core: Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
669668|NCT00355134|E2|Reported Event|Core: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase.
669669|NCT00355134|E1|Reported Event|Core: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
669670|NCT00355121|B4|Baseline|Total|Total of all reporting groups
669671|NCT00355121|B3|Baseline|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669672|NCT00355121|B2|Baseline|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669673|NCT00355121|B1|Baseline|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669674|NCT00355121|P3|Participant Flow|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669675|NCT00355121|P2|Participant Flow|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669676|NCT00355121|P1|Participant Flow|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669840|NCT00354484|O2|Outcome|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
669965|NCT00353977|B1|Baseline|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
669677|NCT00355121|O3|Outcome|Group 3: DAPTACEL on Day 30 (Visit 2)|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669678|NCT00355121|O2|Outcome|Group 2: IPOL on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669679|NCT00355121|O1|Outcome|Group 1: Menactra on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669680|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669681|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669682|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669683|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669684|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669685|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669686|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669687|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669688|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669689|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669690|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669691|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669692|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669693|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669694|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669695|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669696|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669847|NCT00354432|B2|Baseline|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
669697|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669698|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669699|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669700|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669701|NCT00355121|E3|Reported Event|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
669702|NCT00355121|E2|Reported Event|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
669703|NCT00355121|E1|Reported Event|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
669704|NCT00355082|B3|Baseline|Total|Total of all reporting groups
669705|NCT00355082|B2|Baseline|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
669706|NCT00355082|B1|Baseline|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
669707|NCT00355082|P3|Participant Flow|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
669708|NCT00355082|P2|Participant Flow|LTG XR, 250 mg|LTG XR, 250 mg/day
669709|NCT00355082|P1|Participant Flow|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
669710|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
669711|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
669712|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
669713|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
669714|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
669715|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
669716|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
669717|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
669718|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
669719|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
669720|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
669721|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
669722|NCT00355082|O1|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
669723|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
669724|NCT00355082|E4|Reported Event|Continuation Phase: Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
669725|NCT00355082|E3|Reported Event|Continuation Phase: LTG XR, 300 mg|Treatment phase participants; LTG XR, 300 mg/day
669726|NCT00355082|E2|Reported Event|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
669727|NCT00355082|E1|Reported Event|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
669728|NCT00355030|B3|Baseline|Total|Total of all reporting groups
669729|NCT00355030|B2|Baseline|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669730|NCT00355030|B1|Baseline|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669731|NCT00355030|P2|Participant Flow|Somatropin: Experimental Arm 2|0.05mg/kg/day subcutaneous somatropin only
669732|NCT00355030|P1|Participant Flow|Somatropin and Leuprorelin: Experimental Arm 1|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669733|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669734|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669735|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669736|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669737|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669738|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669739|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669740|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669741|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669742|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669743|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669744|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669745|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669746|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669747|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669748|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669749|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
669750|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
669751|NCT00355030|E2|Reported Event|Somatropin|Somatropin n=45
669752|NCT00355030|E1|Reported Event|Somatropin and Leuprorelin|Somatropin and leuprorelin n=46
669753|NCT00354978|B1|Baseline|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
669754|NCT00354978|P1|Participant Flow|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
669755|NCT00354978|O1|Outcome|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
669756|NCT00354978|E1|Reported Event|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
669757|NCT00354913|B1|Baseline|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
669758|NCT00354913|P1|Participant Flow|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
669759|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
669760|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
669761|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
669762|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
669763|NCT00354913|E1|Reported Event|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
669764|NCT00354887|B1|Baseline|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
669765|NCT00354887|P1|Participant Flow|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
669766|NCT00354887|O1|Outcome|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
669767|NCT00354887|E1|Reported Event|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
669768|NCT00354835|B3|Baseline|Total|Total of all reporting groups
669845|NCT00354432|B4|Baseline|Arm IV - Soy + Venlafaxine|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
669769|NCT00354835|B2|Baseline|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669770|NCT00354835|B1|Baseline|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669771|NCT00354835|P2|Participant Flow|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669772|NCT00354835|P1|Participant Flow|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies"
669773|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669774|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669775|NCT00354835|O2|Outcome|PAX7|Fusion positive with PAX7 partner
669776|NCT00354835|O1|Outcome|PAX3|Fusion positive with PAX3 partner
669777|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|
669778|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669779|NCT00354835|O3|Outcome|UGT1A1 Genotype 7/7|
669780|NCT00354835|O2|Outcome|UGT1A1 Genotype 6/7|
669781|NCT00354835|O1|Outcome|UGT1A1 Genotype 6/6|
669782|NCT00354835|O2|Outcome|% Change in SUVmax From Baseline to Week 15 >= 40%|
669783|NCT00354835|O1|Outcome|% Change in SUVmax From Baseline to Week 15 < 40%|
669784|NCT00354835|O2|Outcome|% Change in SUVmax From Baseline to Week 4 >= 40%|
669785|NCT00354835|O1|Outcome|% Change in SUVmax From Baseline to Week 4 < 40%|
669786|NCT00354835|O2|Outcome|VAC (Weeks 31 - 43)|Reporting period 3 (late)
669787|NCT00354835|O1|Outcome|VAC (Weeks 1-15)|Reporting period 1 (acute)
669788|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669789|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669790|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669791|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669841|NCT00354484|O1|Outcome|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
669842|NCT00354484|E2|Reported Event|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
669792|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669793|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669794|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669795|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669796|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669797|NCT00354835|O2|Outcome|VAC Alternating With Vincristine, Irinotecan (VI)|Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
669798|NCT00354835|O1|Outcome|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies"
669799|NCT00354835|E2|Reported Event|VAC Alternating With VI|"Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Irinotecan Hydrochloride: Given IV~Dactinomycin: Given IV~Cyclophosphamide: Given IV~Vincristine Sulfate: Given IV~Radiation Therapy: Undergo radiotherapy~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
669800|NCT00354835|E1|Reported Event|Vincristine, Dactinomycin, Cyclophosphamide (VAC)|"Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.~Dactinomycin: Given IV~Cyclophosphamide: Given IV~Vincristine Sulfate: Given IV~Radiation Therapy: Undergo radiotherapy~Laboratory Biomarker Analysis: Correlative studies~Questionnaire Administration: Ancillary studies"
669801|NCT00354770|B3|Baseline|Total|Total of all reporting groups
669802|NCT00354770|B2|Baseline|Placebo|Placebo pills
669803|NCT00354770|B1|Baseline|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
669804|NCT00354770|P2|Participant Flow|Placebo|Placebo pills
669805|NCT00354770|P1|Participant Flow|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
669806|NCT00354770|O2|Outcome|Placebo|Placebo pills
669807|NCT00354770|O1|Outcome|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
669808|NCT00354770|E2|Reported Event|Placebo|Placebo pills
669809|NCT00354770|E1|Reported Event|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
669810|NCT00354744|B1|Baseline|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
669843|NCT00354484|E1|Reported Event|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
669844|NCT00354432|B5|Baseline|Total|Total of all reporting groups
669846|NCT00354432|B3|Baseline|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
669811|NCT00354744|P1|Participant Flow|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
669812|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Patients with parameningeal (without intracranial extension) and paraspinal tumors should receive chemotherapy beginning Week 1 and begin radiation therapy at Week 20. Weeks 1-6 vincristine sulfate (VCR) & irinotecan hydrochloride (IRIN), Weeks 7-34 vincristine sulfate (VCR), Cyclophosphamide (CPM) with MESNA, Doxorubicin hydrochloride (DOX), Etoposide (ETOP), Ifosfamide (IFOS) with MESNA. Weeks 35-54 vincristine sulfate (VCR), Dactinomycin (DACT) and Cyclophosphamide (CPM) with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
669813|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
669814|NCT00354744|E1|Reported Event|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
669815|NCT00354679|B1|Baseline|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
669816|NCT00354679|P1|Participant Flow|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
669817|NCT00354679|O1|Outcome|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
669818|NCT00354679|E1|Reported Event|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
669819|NCT00354640|B1|Baseline|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
669820|NCT00354640|P1|Participant Flow|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
669821|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
669822|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
669823|NCT00354640|E1|Reported Event|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
669824|NCT00354614|B1|Baseline|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
669825|NCT00354614|P1|Participant Flow|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
669826|NCT00354614|O1|Outcome|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
669827|NCT00354614|E1|Reported Event|Suspicion of Obstructive Sleep Apnea|Patients referred to a sleep clinic because of suspicion of obstructive sleep apnea underwent simultaneous polysomnography and ApneaLink testing
669828|NCT00354601|B1|Baseline|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
669829|NCT00354601|P1|Participant Flow|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
669830|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
669831|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
669832|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
669833|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
669834|NCT00354601|E1|Reported Event|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
669835|NCT00354484|B3|Baseline|Total|Total of all reporting groups
669836|NCT00354484|B2|Baseline|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
669837|NCT00354484|B1|Baseline|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
669838|NCT00354484|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
669839|NCT00354484|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
669848|NCT00354432|B1|Baseline|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
669849|NCT00354432|P4|Participant Flow|Arm IV - Soy + Venlafaxin|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
669850|NCT00354432|P3|Participant Flow|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
669851|NCT00354432|P2|Participant Flow|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
669852|NCT00354432|P1|Participant Flow|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
669853|NCT00354432|O4|Outcome|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
669854|NCT00354432|O3|Outcome|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
669855|NCT00354432|O2|Outcome|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
669856|NCT00354432|O1|Outcome|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
669857|NCT00354432|O4|Outcome|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
669858|NCT00354432|O3|Outcome|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
669859|NCT00354432|O2|Outcome|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
669860|NCT00354432|O1|Outcome|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
669861|NCT00354432|E4|Reported Event|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
669862|NCT00354432|E3|Reported Event|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
669863|NCT00354432|E2|Reported Event|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
669864|NCT00354432|E1|Reported Event|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
669865|NCT00354341|B3|Baseline|Total|Total of all reporting groups
669866|NCT00354341|B2|Baseline|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669867|NCT00354341|B1|Baseline|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669868|NCT00354341|P2|Participant Flow|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669869|NCT00354341|P1|Participant Flow|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669870|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669871|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669872|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669873|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669874|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669875|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669901|NCT00354172|E1|Reported Event|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669902|NCT00354159|B3|Baseline|Total|Total of all reporting groups
669876|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669877|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669878|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669879|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669880|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669881|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669882|NCT00354341|E2|Reported Event|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
669883|NCT00354341|E1|Reported Event|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
669884|NCT00354172|B1|Baseline|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669885|NCT00354172|P1|Participant Flow|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669886|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669887|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669888|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669889|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669890|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669891|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669892|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669893|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669894|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669895|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669896|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669897|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669898|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669899|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669900|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
669956|NCT00354029|B3|Baseline|Total|Total of all reporting groups
669903|NCT00354159|B2|Baseline|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669904|NCT00354159|B1|Baseline|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669905|NCT00354159|P2|Participant Flow|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669906|NCT00354159|P1|Participant Flow|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669907|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669908|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669909|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669910|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669911|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
669912|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
669913|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669914|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669915|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669916|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669917|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669918|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669919|NCT00354159|O2|Outcome|Heart Failure Event Control Subjects|Subjects randomized to the Control Arm that had a heart failure event during the 12-month randomized period
669920|NCT00354159|O1|Outcome|Heart Failure Event Free Control Subjects|Subjects randomized to the Control Arm that did not have a heart failure related event during the 12-month randomized period
669921|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669922|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669923|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669924|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669925|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669926|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669927|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669928|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669929|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669930|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669931|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
669932|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669933|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
669934|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669935|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
669936|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669937|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
669938|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669939|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
669940|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669941|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669942|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669943|NCT00354159|O1|Outcome|Chronicle IHM Implanted Subjects|Analysis cohort includes the one subject with a Chronicle IHM implant attempt
669944|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.
669945|NCT00354159|E3|Reported Event|Enrolled, Not Randomized|42 subjects were enrolled but exited the study prior to randomization
669946|NCT00354159|E2|Reported Event|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
669947|NCT00354159|E1|Reported Event|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
669957|NCT00354029|B2|Baseline|Placebo|
669948|NCT00354107|B1|Baseline|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669949|NCT00354107|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669950|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669951|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669952|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669953|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669954|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669955|NCT00354107|E1|Reported Event|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
669966|NCT00353977|P1|Participant Flow|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
669967|NCT00353977|O1|Outcome|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
669968|NCT00353977|E1|Reported Event|Alvac pp65 Vaccine|Subjects received 1, 2 or 3 doses of the vaccine
669969|NCT00353873|B3|Baseline|Total|Total of all reporting groups
669970|NCT00353873|B2|Baseline|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669971|NCT00353873|B1|Baseline|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669972|NCT00353873|P2|Participant Flow|Salmeterol/Fluticasone Propionate (SFC) 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669973|NCT00353873|P1|Participant Flow|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669974|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669975|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669976|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669977|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669978|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669979|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669980|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669981|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669982|NCT00353873|E2|Reported Event|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669983|NCT00353873|E1|Reported Event|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
669984|NCT00353834|B3|Baseline|Total|Total of all reporting groups
669985|NCT00353834|B2|Baseline|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
669986|NCT00353834|B1|Baseline|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
669987|NCT00353834|P2|Participant Flow|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
669988|NCT00353834|P1|Participant Flow|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
669989|NCT00353834|O2|Outcome|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
669990|NCT00353834|O1|Outcome|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
669991|NCT00353834|O2|Outcome|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
669992|NCT00353834|O1|Outcome|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
669993|NCT00353834|E2|Reported Event|Exenatide|"Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.~Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks"
669994|NCT00353834|E1|Reported Event|Glargine Insulin|"Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.~Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia."
669995|NCT00353795|B1|Baseline|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
669996|NCT00353795|P1|Participant Flow|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
669997|NCT00353795|O1|Outcome|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
669998|NCT00353795|E1|Reported Event|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
669999|NCT00353704|B3|Baseline|Total|Total of all reporting groups
670000|NCT00353704|B2|Baseline|Placebo|
670001|NCT00353704|B1|Baseline|Pregabalin|
670002|NCT00353704|P2|Participant Flow|Placebo|
670003|NCT00353704|P1|Participant Flow|Pregabalin|
670004|NCT00353704|O2|Outcome|Placebo|
670005|NCT00353704|O1|Outcome|Pregabalin|
670006|NCT00353704|O2|Outcome|Placebo|
670007|NCT00353704|O1|Outcome|Pregabalin|
670008|NCT00353704|E2|Reported Event|Placebo|
670009|NCT00353704|E1|Reported Event|Pregabalin|
670010|NCT00353652|B7|Baseline|Total|Total of all reporting groups
670011|NCT00353652|B6|Baseline|Spironolactone|Spironolactone: 25-75 mg taken orally, once daily
670012|NCT00353652|B5|Baseline|Chlorthalidone|Chlorthalidone: 12.5-25 mg taken orally, once daily
670013|NCT00353652|B4|Baseline|Irbesartan|"Drug: Irbesartan~150 mg taken orally, once daily"
670014|NCT00353652|B3|Baseline|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
670015|NCT00353652|B2|Baseline|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
670016|NCT00353652|B1|Baseline|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
670017|NCT00353652|P6|Participant Flow|Spironolactone|Spironolactone 25-75 mg taken orally daily
670018|NCT00353652|P5|Participant Flow|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
670019|NCT00353652|P4|Participant Flow|Irbesartan|"Drug: Irbesartan~150 mg taken orally, once daily"
670020|NCT00353652|P3|Participant Flow|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
670021|NCT00353652|P2|Participant Flow|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
670022|NCT00353652|P1|Participant Flow|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
670023|NCT00353652|O6|Outcome|Irbesartan|Irbesartan 150 mg taken orally once a day
670024|NCT00353652|O5|Outcome|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally
670025|NCT00353652|O4|Outcome|Spironolactone|Spironolactone 25-50 mg taken orally daily
670026|NCT00353652|O3|Outcome|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
670027|NCT00353652|O2|Outcome|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
670028|NCT00353652|O1|Outcome|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
670029|NCT00353652|E6|Reported Event|Spironolactone|Spironolactone 25-75 mg taken orally daily
670030|NCT00353652|E5|Reported Event|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
670031|NCT00353652|E4|Reported Event|Irbesartan|Drug: Irbesartan 150 mg taken orally, once daily
670032|NCT00353652|E3|Reported Event|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
670033|NCT00353652|E2|Reported Event|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
670034|NCT00353652|E1|Reported Event|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
670035|NCT00353496|B3|Baseline|Total|Total of all reporting groups
670036|NCT00353496|B2|Baseline|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
670037|NCT00353496|B1|Baseline|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
670038|NCT00353496|P2|Participant Flow|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
670039|NCT00353496|P1|Participant Flow|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
670040|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670041|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670042|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670043|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670044|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670045|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670046|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
670047|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670048|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670049|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670050|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
670051|NCT00353496|E2|Reported Event|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
670052|NCT00353496|E1|Reported Event|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
670053|NCT00353431|B3|Baseline|Total|Total of all reporting groups
670054|NCT00353431|B2|Baseline|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670055|NCT00353431|B1|Baseline|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670056|NCT00353431|P2|Participant Flow|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670057|NCT00353431|P1|Participant Flow|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670058|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670059|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670060|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670061|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670062|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670063|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670064|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670107|NCT00353275|P1|Participant Flow|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
670065|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670066|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670067|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670068|NCT00353431|E2|Reported Event|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
670069|NCT00353431|E1|Reported Event|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
670070|NCT00353418|B3|Baseline|Total|Total of all reporting groups
670071|NCT00353418|B2|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670072|NCT00353418|B1|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670073|NCT00353418|P2|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670074|NCT00353418|P1|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670075|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670076|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670077|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670078|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670079|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670080|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670081|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670082|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670083|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670084|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670085|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670086|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670087|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670088|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670089|NCT00353418|E2|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
670090|NCT00353418|E1|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
670091|NCT00353366|B1|Baseline|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
670092|NCT00353366|P1|Participant Flow|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
670093|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
670094|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
670095|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
670096|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
670097|NCT00353366|E1|Reported Event|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
670098|NCT00353301|B1|Baseline|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
670099|NCT00353301|P1|Participant Flow|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
670100|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
670101|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
670102|NCT00353301|E1|Reported Event|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
670103|NCT00353275|B3|Baseline|Total|Total of all reporting groups
670104|NCT00353275|B2|Baseline|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
670105|NCT00353275|B1|Baseline|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
670106|NCT00353275|P2|Participant Flow|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
670108|NCT00353275|O2|Outcome|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
670109|NCT00353275|O1|Outcome|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
670110|NCT00353275|E2|Reported Event|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
670111|NCT00353275|E1|Reported Event|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
670112|NCT00353262|B1|Baseline|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670113|NCT00353262|P1|Participant Flow|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670114|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670115|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670116|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670117|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670118|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670163|NCT00352846|P2|Participant Flow|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
670164|NCT00352846|P1|Participant Flow|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
670261|NCT00352365|B1|Baseline|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
670119|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670120|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670121|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670122|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670123|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670124|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670125|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670126|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670127|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670128|NCT00353262|E1|Reported Event|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
670129|NCT00353119|B3|Baseline|Total|Total of all reporting groups
670130|NCT00353119|B2|Baseline|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
670131|NCT00353119|B1|Baseline|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
670132|NCT00353119|P2|Participant Flow|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
670133|NCT00353119|P1|Participant Flow|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
670134|NCT00353119|O1|Outcome|Etanercept After Placebo|Group 1 patients that crossed over to etanercept 50mg twice weekly for weeks 12 to 24 after having initiated the study with placebo for the first 12 weeks
670135|NCT00353119|O1|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
670136|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND Patients that crossed over to etanercept 50 mg subcutanously twice weekly after taking placebo for the first 12 weeks.
670137|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
670138|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
670139|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
670140|NCT00353119|E2|Reported Event|Etanercept|Patients randomized to etanercept who received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND patients who crossed over to etanercept 50 mg subcutaneously twice a week for 12 weeks.
670141|NCT00353119|E1|Reported Event|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks
670142|NCT00352911|B3|Baseline|Total|Total of all reporting groups
670143|NCT00352911|B2|Baseline|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670144|NCT00352911|B1|Baseline|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670145|NCT00352911|P2|Participant Flow|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670146|NCT00352911|P1|Participant Flow|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670147|NCT00352911|O2|Outcome|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670148|NCT00352911|O1|Outcome|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670149|NCT00352911|E2|Reported Event|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670150|NCT00352911|E1|Reported Event|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
670151|NCT00352885|B3|Baseline|Total|Total of all reporting groups
670152|NCT00352885|B2|Baseline|Placebo|Participants will receive placebo and IL-2 treatment
670153|NCT00352885|B1|Baseline|Escitalopram|Participants will receive escitalopram and IL-2 treatment
670154|NCT00352885|P2|Participant Flow|Placebo|Participants will receive placebo 2 weeks before and during IL-2 treatment
670155|NCT00352885|P1|Participant Flow|Escitalopram|Participants will receive escitalopram 10-20 mg/day 2 weeks before and during IL-2 treatment
670156|NCT00352885|O2|Outcome|Placebo|Participants will receive placebo and IL-2 treatment
670157|NCT00352885|O1|Outcome|Escitalopram|Participants will receive escitalopram and IL-2 treatment
670158|NCT00352885|E2|Reported Event|Placebo|Participants will receive placebo and IL-2 treatment
670159|NCT00352885|E1|Reported Event|Escitalopram|Participants will receive escitalopram and IL-2 treatment
670160|NCT00352846|B3|Baseline|Total|Total of all reporting groups
670161|NCT00352846|B2|Baseline|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
670162|NCT00352846|B1|Baseline|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
670251|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
670252|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
670165|NCT00352846|O2|Outcome|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
670166|NCT00352846|O1|Outcome|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
670167|NCT00352846|E2|Reported Event|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
670168|NCT00352846|E1|Reported Event|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
670169|NCT00352781|B1|Baseline|Nicotine Replacement Therapy (NRT)|Open-label Nicotine Replacement Therapy + counseling
670170|NCT00352781|P1|Participant Flow|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy (as per product monograph) + counseling
670171|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
670172|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
670173|NCT00352781|E1|Reported Event|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy + counseling
670174|NCT00352755|B1|Baseline|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670175|NCT00352755|P1|Participant Flow|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670176|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670177|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670178|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670179|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670180|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670181|NCT00352755|E1|Reported Event|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m2 over 2 hours with leucovorin at 400 mg/m2 and IV 5-FU at 2400 mg/m2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
670182|NCT00352690|B3|Baseline|Total|Total of all reporting groups
670183|NCT00352690|B2|Baseline|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670184|NCT00352690|B1|Baseline|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670185|NCT00352690|P2|Participant Flow|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670186|NCT00352690|P1|Participant Flow|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670187|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670188|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670189|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670190|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670191|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670192|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670193|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670194|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670195|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670196|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670197|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670198|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670253|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
670254|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
670255|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
670256|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
670199|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670200|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670201|NCT00352690|E2|Reported Event|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670202|NCT00352690|E1|Reported Event|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
670203|NCT00352664|B3|Baseline|Total|Total of all reporting groups
670204|NCT00352664|B2|Baseline|Placebo|Oral Placebo tablet daily x 7 days
670205|NCT00352664|B1|Baseline|Donepezil|Oral Donepezil 5 mg daily x 7 days
670206|NCT00352664|P2|Participant Flow|Placebo|Oral Placebo tablet daily x 7 days
670207|NCT00352664|P1|Participant Flow|Donepezil|Oral Donepezil 5 mg daily x 7 days
670208|NCT00352664|O2|Outcome|Placebo|Oral Placebo tablet daily x 7 days
670209|NCT00352664|O1|Outcome|Donepezil|Oral Donepezil 5 mg daily x 7 days
670210|NCT00352664|E2|Reported Event|Placebo|Oral Placebo tablet daily x 7 days
670211|NCT00352664|E1|Reported Event|Donepezil|Oral Donepezil 5 mg daily x 7 days
670212|NCT00352612|B3|Baseline|Total|Total of all reporting groups
670213|NCT00352612|B2|Baseline|Group 2|clindamycin arm
670214|NCT00352612|B1|Baseline|Group 1|cephalexin arm
670215|NCT00352612|P2|Participant Flow|Clindamycin|those who received clindamycin
670216|NCT00352612|P1|Participant Flow|Cephalexin|patients who received cephalexin
670217|NCT00352612|O2|Outcome|Clindamycin|those patients who received clindamycin
670218|NCT00352612|O1|Outcome|Cephalexin|those patients who received cephalexin
670219|NCT00352612|E2|Reported Event|Clindamycin|
670220|NCT00352612|E1|Reported Event|Cephalexin|
670221|NCT00352534|B3|Baseline|Total|Total of all reporting groups
670222|NCT00352534|B2|Baseline|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
670223|NCT00352534|B1|Baseline|Stage I or II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment.
670224|NCT00352534|P7|Participant Flow|High Risk|Treatment arm. High risk.
670225|NCT00352534|P6|Participant Flow|Standard Risk, Stage III|Treatment arm. Standard Risk, Stage III.
670226|NCT00352534|P5|Participant Flow|Standard Risk, Stage I or II With LOH|Treatment arm. Standard Risk, Stage I or II with LOH.
670227|NCT00352534|P4|Participant Flow|Low Risk, Stage I or II, no LOH|Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).
670228|NCT00352534|P3|Participant Flow|Very Low Risk Disease|Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.
670229|NCT00352534|P2|Participant Flow|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
670230|NCT00352534|P1|Participant Flow|Stage I/II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment
670231|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
670232|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
670233|NCT00352534|O3|Outcome|Standard Risk, Stage III|Standard Risk, Stage III
670234|NCT00352534|O2|Outcome|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with LOH
670235|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
670236|NCT00352534|O3|Outcome|Standard Risk, Stage III|Standard Risk, Stage III
670237|NCT00352534|O2|Outcome|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with LOH
670238|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
670239|NCT00352534|E5|Reported Event|High Risk|High risk.
670240|NCT00352534|E4|Reported Event|Standard Risk, Stage III|Nephrectomy/Biopsy, Chemotherapy
670241|NCT00352534|E3|Reported Event|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with loss of heterozygosity (LOH).
670242|NCT00352534|E2|Reported Event|Low Risk, Stage I or II, no LOH|Low risk, stage I or II, no loss of heterozygosity (LOH).
670243|NCT00352534|E1|Reported Event|Very Low Risk Disease|Nephrectomy and Re-evaluation
670244|NCT00352417|B3|Baseline|Total|Total of all reporting groups
670245|NCT00352417|B2|Baseline|Matching Placebo|Placebo Dose
670246|NCT00352417|B1|Baseline|VIA-2291|100-mg dose
670247|NCT00352417|P2|Participant Flow|Matching Placebo|Placebo Dose
670248|NCT00352417|P1|Participant Flow|VIA-2291|100-mg dose
670249|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
670250|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
670262|NCT00352365|P1|Participant Flow|Lenalidomide|Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
670263|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
670264|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
670265|NCT00352365|O2|Outcome|Nonresponders|Eligible and evaluable patients who did not achieve CR/CRi/PR
670266|NCT00352365|O1|Outcome|Responders|Eligible and evaluable patients who achieved CR/CRi/PR
670267|NCT00352365|O2|Outcome|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
670268|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
670269|NCT00352365|E2|Reported Event|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
670270|NCT00352365|E1|Reported Event|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
670271|NCT00352118|B1|Baseline|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670272|NCT00352118|P1|Participant Flow|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670273|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670274|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670275|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670276|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670277|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670278|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670279|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670280|NCT00352118|E1|Reported Event|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
670281|NCT00352105|B1|Baseline|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670282|NCT00352105|P1|Participant Flow|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670283|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670284|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670285|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670286|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670287|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670288|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670289|NCT00352105|E1|Reported Event|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
670290|NCT00352053|B3|Baseline|Total|Total of all reporting groups
670291|NCT00352053|B2|Baseline|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
670292|NCT00352053|B1|Baseline|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
670293|NCT00352053|P2|Participant Flow|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
670294|NCT00352053|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablets plus a genotype-guided optimized background regimen (OBR; 3 minimum (min.)/5 maximum (max.) antiretroviral agents (ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
670295|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670296|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670297|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670298|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670299|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670300|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670301|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670302|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670303|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670304|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670305|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670306|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670307|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670308|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670309|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670310|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670311|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670312|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670313|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670314|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670683|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670315|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670316|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670317|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670318|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670319|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670320|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670321|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670322|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670323|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670324|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670325|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670326|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670327|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670328|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670329|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670330|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670331|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670332|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670333|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670334|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670335|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670518|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670336|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670337|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670338|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670339|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670340|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670341|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670342|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670343|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670344|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670345|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670346|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670347|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670348|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670349|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670350|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670351|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670352|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670353|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670354|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670355|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670356|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670622|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670357|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670358|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670359|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670360|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670361|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670362|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670363|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670364|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670365|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670366|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670367|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670368|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670369|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670370|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670371|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670372|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670373|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670374|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670375|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670376|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670377|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670507|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670378|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670379|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670380|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670381|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670382|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670383|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670384|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670385|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670386|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670387|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670388|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670389|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670390|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670391|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670392|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670393|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670394|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670395|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670396|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670397|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670398|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670508|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670399|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670400|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670401|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670402|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670403|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670404|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670405|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670406|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670407|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670408|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670409|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670410|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670411|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670412|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670413|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670414|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670415|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670416|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670417|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670418|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670419|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670509|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670623|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670420|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670421|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670422|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670423|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670424|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670425|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670426|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670427|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670428|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670429|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670430|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670431|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670432|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670433|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670434|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670435|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670436|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670437|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670438|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670439|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670440|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670510|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670441|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670442|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670443|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670444|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
670445|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670446|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670447|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670448|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670449|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670450|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
670451|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670452|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670453|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670454|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670455|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670456|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
670457|NCT00352053|E3|Reported Event|All TDF|"Adverse events reported for the All TDF group include those reported during the double-blind phase and/or extension phase for subjects who were randomized to TDF group plus adverse events reported during the extension phase only for subjects who switched from placebo to open-label TDF.~Tenofovir DF 300-mg tablets in participants initially randomized to the Tenofovir DF group, and in those initially randomized to the Placebo group who later switched to open-label TDF 300 mg."
670458|NCT00352053|E2|Reported Event|Placebo|"Adverse events occurring in the double-blind phase are presented for this reporting group.~Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
670459|NCT00352053|E1|Reported Event|Tenofovir DF|"Adverse events occurring in the double-blind phase are presented for this reporting group.~TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
670511|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670512|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670513|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670460|NCT00352027|B1|Baseline|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670461|NCT00352027|P1|Participant Flow|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670462|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670463|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670464|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670465|NCT00352027|O8|Outcome|HOD99 - Grade 5|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
670466|NCT00352027|O7|Outcome|HOD99 - Grade 4|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
670467|NCT00352027|O6|Outcome|HOD99 - Grade 3|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
670468|NCT00352027|O5|Outcome|HOD99 - Grade 2|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
670469|NCT00352027|O4|Outcome|HOD05 - Grade 5|Participants in current study.
670470|NCT00352027|O3|Outcome|HOD05 - Grade 4|Participants in current study.
670471|NCT00352027|O2|Outcome|HOD05 - Grade 3|Participants in current study.
670472|NCT00352027|O1|Outcome|HOD05 - Grade 2|Participants in current study.
670473|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
670474|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670475|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
670514|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670515|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670516|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670517|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670476|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670477|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
670478|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670479|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670480|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670481|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670482|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670483|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670484|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670485|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670486|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670487|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670488|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670489|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670490|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670491|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670492|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670493|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
670494|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670495|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670496|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670497|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670498|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670499|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670500|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670501|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670502|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670503|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670504|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670505|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670506|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670519|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670520|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670521|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670522|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670523|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670524|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670525|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670526|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670527|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670528|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670529|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670530|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670531|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670532|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670533|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670534|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670535|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670536|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670537|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670538|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670539|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670540|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670541|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670542|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670543|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670544|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670545|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670546|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670547|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670548|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670549|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670550|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670551|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670552|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670553|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670554|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670555|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670556|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670557|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670558|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670559|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670560|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670561|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670562|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670563|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670564|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670565|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
670624|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670566|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670567|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670568|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
670569|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670570|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670571|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670572|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670573|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670574|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670575|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670576|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670577|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670578|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670579|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670580|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670581|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670582|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670583|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670584|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670585|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670586|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670587|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670588|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670589|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670590|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670591|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670592|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670593|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670594|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670595|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670596|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670597|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670598|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670599|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670600|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670601|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670602|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670603|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670604|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670605|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670606|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670607|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670608|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670609|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670610|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670611|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670612|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670613|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670614|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670615|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670616|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670617|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670618|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670619|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670620|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670621|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670625|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670626|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670627|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670628|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670629|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670630|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670631|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670632|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670633|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670634|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670635|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670636|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670637|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670638|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670639|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670640|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670641|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670642|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670643|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670644|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670645|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670646|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670647|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670648|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670649|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670650|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670651|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670652|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670653|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670654|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670655|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670656|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670657|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670658|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670659|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670660|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670661|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670662|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670663|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670664|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670665|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670666|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670667|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670668|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670669|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670670|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670671|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670672|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670673|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670674|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670675|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670676|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670677|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670678|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670679|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670680|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670681|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670682|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670684|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670685|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670686|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670687|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670688|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670689|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670690|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670691|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670692|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670693|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670694|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670695|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670696|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670697|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670698|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670699|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670700|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670701|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670702|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670703|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670704|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670705|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670706|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670707|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670708|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670709|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670710|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670711|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670712|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670713|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670714|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670715|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670716|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670717|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670718|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670719|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
670720|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
670721|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
670722|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
670723|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
670724|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670725|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670726|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670758|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670759|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670727|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670728|NCT00352027|E1|Reported Event|Stanford V Chemotherapy|"Intermediate risk single arm study defined as~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
670729|NCT00351936|B1|Baseline|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
670730|NCT00351936|P1|Participant Flow|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
670731|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
670732|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
670733|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
670734|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
670735|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
670736|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
670737|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
670738|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
670739|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
670740|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
670741|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
670742|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
670743|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
670744|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
670745|NCT00351936|E1|Reported Event|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
670746|NCT00351819|B3|Baseline|Total|Total of all reporting groups
670747|NCT00351819|B2|Baseline|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670748|NCT00351819|B1|Baseline|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670749|NCT00351819|P2|Participant Flow|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670750|NCT00351819|P1|Participant Flow|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670751|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670752|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670753|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670754|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670755|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670756|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670757|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670760|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670761|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670762|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670763|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670764|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670765|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670766|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670767|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670768|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670769|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670770|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670771|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670772|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670773|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670774|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670775|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670776|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670777|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670778|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670779|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670780|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670781|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670782|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670783|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670784|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670785|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670786|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670787|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670788|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670789|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670790|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670791|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670792|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670793|NCT00351819|O2|Outcome|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670794|NCT00351819|O1|Outcome|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670795|NCT00351819|E2|Reported Event|Placebo|"Placebo gel~Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders."
670796|NCT00351819|E1|Reported Event|Androgel (Testosterone Gel)|"Testosterone replacement therapy~Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders."
670797|NCT00351741|B3|Baseline|Total|Total of all reporting groups
670798|NCT00351741|B2|Baseline|Conventional|Low-tidal volume ventilation
670799|NCT00351741|B1|Baseline|High Frequency|Intervention with high frequency percussive ventilation
670800|NCT00351741|P2|Participant Flow|Conventional|Low-tidal volume ventilation
670801|NCT00351741|P1|Participant Flow|High Frequency|Intervention with high frequency percussive ventilation
670802|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
670803|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
670804|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
670805|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
670806|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
670807|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
670808|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
670809|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
670810|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
670811|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
670812|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
670813|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
670814|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
670815|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
670816|NCT00351741|E2|Reported Event|Conventional|Low-tidal volume ventilation
670817|NCT00351741|E1|Reported Event|High Frequency|Intervention with high frequency percussive ventilation
670818|NCT00351533|B3|Baseline|Total|Total of all reporting groups
670819|NCT00351533|B2|Baseline|Enteral Saline|7.5cc 0.9% saline every 6 hours
670820|NCT00351533|B1|Baseline|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670821|NCT00351533|P2|Participant Flow|Enteral Saline|7.5cc 0.9% saline every 6 hours
670822|NCT00351533|P1|Participant Flow|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670823|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670824|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670825|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670826|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670827|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670828|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670829|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670830|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670831|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670832|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670833|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670834|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670835|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670836|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670837|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670838|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670839|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670840|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670841|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670842|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670843|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670844|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670845|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670846|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670847|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670848|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670849|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670850|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670851|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670852|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670853|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670854|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670855|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670856|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670857|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670858|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670859|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670860|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670861|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670862|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670863|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670864|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670865|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670866|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670867|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670868|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670869|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670870|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670871|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670872|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670873|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670874|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670875|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670876|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670877|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
670878|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670879|NCT00351533|E2|Reported Event|Enteral Saline|7.5cc 0.9% saline every 6 hours
670880|NCT00351533|E1|Reported Event|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
670881|NCT00351468|B1|Baseline|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670882|NCT00351468|P1|Participant Flow|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670883|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670884|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670885|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670886|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670887|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670888|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670889|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670890|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670891|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670892|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670893|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
670894|NCT00351468|E2|Reported Event|Eltrombopag, >1 to 30 Days Post-Therapy|Eltrombopag, >1 to 30 Days Post-Therapy
670895|NCT00351468|E1|Reported Event|Eltrombopag, Treatment + 1 Day|Eltrombopag, Treatment + 1 day
670896|NCT00351416|B3|Baseline|Total|Total of all reporting groups
670897|NCT00351416|B2|Baseline|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670898|NCT00351416|B1|Baseline|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670899|NCT00351416|P2|Participant Flow|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670900|NCT00351416|P1|Participant Flow|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670901|NCT00351416|O2|Outcome|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670902|NCT00351416|O1|Outcome|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670903|NCT00351416|E2|Reported Event|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670904|NCT00351416|E1|Reported Event|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
670905|NCT00351377|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670906|NCT00351377|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670907|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670908|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670909|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670910|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670911|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670912|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670913|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670914|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670915|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670916|NCT00351377|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
670917|NCT00351351|B3|Baseline|Total|Total of all reporting groups
670918|NCT00351351|B2|Baseline|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
670919|NCT00351351|B1|Baseline|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
671083|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
670920|NCT00351351|P2|Participant Flow|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
670921|NCT00351351|P1|Participant Flow|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
670922|NCT00351351|O2|Outcome|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
670923|NCT00351351|O1|Outcome|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
670924|NCT00351351|E2|Reported Event|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
670925|NCT00351351|E1|Reported Event|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
670926|NCT00351299|B3|Baseline|Total|Total of all reporting groups
670927|NCT00351299|B2|Baseline|Standard of Care|Standard of care per treating physician preference
670928|NCT00351299|B1|Baseline|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670929|NCT00351299|P2|Participant Flow|Standard of Care|Standard of care per treating physician preference
670930|NCT00351299|P1|Participant Flow|Infusion of Dexmedetomidine|"infusion 0.2-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670931|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating physician's preference
670932|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670933|NCT00351299|O2|Outcome|Standard of Care|Standard of care per attending physician's preference
670934|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670935|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per attending physician preference
670936|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670937|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating physician preference
670938|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670939|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating attending physician preference
670940|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670941|NCT00351299|E2|Reported Event|Standard of Care|Standard of care per treating physician preference
670942|NCT00351299|E1|Reported Event|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
670943|NCT00351273|B4|Baseline|Total|Total of all reporting groups
670944|NCT00351273|B3|Baseline|Placebo|Participants will receive placebo
670945|NCT00351273|B2|Baseline|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
670946|NCT00351273|B1|Baseline|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
670947|NCT00351273|P3|Participant Flow|Placebo|Participants will receive placebo
670948|NCT00351273|P2|Participant Flow|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
670949|NCT00351273|P1|Participant Flow|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
670950|NCT00351273|O3|Outcome|Placebo|Participants will receive placebo
670951|NCT00351273|O2|Outcome|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
670952|NCT00351273|O1|Outcome|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
670953|NCT00351273|E3|Reported Event|Placebo|Participants will receive placebo
670954|NCT00351273|E2|Reported Event|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
670955|NCT00351273|E1|Reported Event|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
670956|NCT00351039|B1|Baseline|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
670957|NCT00351039|P1|Participant Flow|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
670958|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
670959|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
670960|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
670961|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
670962|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
670963|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
670964|NCT00351039|E1|Reported Event|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
670965|NCT00351000|B1|Baseline|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
670966|NCT00351000|P1|Participant Flow|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
670967|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
670968|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
670969|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's olanzapine dosage will be unchanged during the trial.
670970|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dosage will be unchanged during the trial.
670971|NCT00351000|E1|Reported Event|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
670972|NCT00350870|B5|Baseline|Total|Total of all reporting groups
670973|NCT00350870|B4|Baseline|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
670974|NCT00350870|B3|Baseline|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
670975|NCT00350870|B2|Baseline|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
670976|NCT00350870|B1|Baseline|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
670977|NCT00350870|P4|Participant Flow|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
670978|NCT00350870|P3|Participant Flow|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
670979|NCT00350870|P2|Participant Flow|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
670980|NCT00350870|P1|Participant Flow|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
670981|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
670982|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
670983|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
670984|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
670985|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
670986|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
670987|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
670988|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
670989|NCT00350870|E4|Reported Event|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
670990|NCT00350870|E3|Reported Event|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
670991|NCT00350870|E2|Reported Event|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
670992|NCT00350870|E1|Reported Event|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
670993|NCT00350844|B1|Baseline|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
670994|NCT00350844|P1|Participant Flow|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
670995|NCT00350844|O1|Outcome|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
670996|NCT00350844|E1|Reported Event|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
670997|NCT00350792|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
670998|NCT00350792|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
670999|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
671000|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
671001|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
671002|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
671003|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
671004|NCT00350792|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
671005|NCT00350779|B3|Baseline|Total|Total of all reporting groups
671006|NCT00350779|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671007|NCT00350779|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671008|NCT00350779|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671009|NCT00350779|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671010|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671035|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671011|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671012|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671013|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671014|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671015|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671016|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671017|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671018|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671019|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671020|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671021|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671022|NCT00350779|E4|Reported Event|Placebo Data Through Week 54|
671023|NCT00350779|E3|Reported Event|Sitagliptin 100 mg Data Through Week 54|
671024|NCT00350779|E2|Reported Event|Placebo Data Through Week 18|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671025|NCT00350779|E1|Reported Event|Sitagliptin 100 mg Data Through Week 18|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
671026|NCT00350727|B4|Baseline|Total|Total of all reporting groups
671027|NCT00350727|B3|Baseline|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671028|NCT00350727|B2|Baseline|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671029|NCT00350727|B1|Baseline|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
671030|NCT00350727|P3|Participant Flow|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671031|NCT00350727|P2|Participant Flow|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671032|NCT00350727|P1|Participant Flow|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
671033|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671034|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671036|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
671037|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671038|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671039|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671040|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671041|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671042|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671043|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671044|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
671045|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671046|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671047|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671048|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671049|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671050|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671051|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671052|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671053|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671054|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671055|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671056|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671057|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671058|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671059|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671060|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671061|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671062|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671063|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671064|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671065|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671066|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671067|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671068|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671069|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671070|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671071|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671072|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671073|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671074|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671075|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671076|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671077|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671078|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671079|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671080|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671081|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671082|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671084|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671085|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671086|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671087|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671088|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671089|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671090|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671091|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671092|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671093|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671094|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671095|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671096|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671097|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671098|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671099|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671100|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671101|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671102|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671103|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671104|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671105|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671106|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671107|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671108|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671109|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671110|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671111|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671112|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671113|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671114|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671115|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671116|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671117|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671118|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671119|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671120|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671121|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671122|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671123|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671124|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671125|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671126|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671127|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671128|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671129|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
671130|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
671131|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
671132|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
671133|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
671134|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
671135|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671136|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671137|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671138|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671139|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671140|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671141|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671142|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671143|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671144|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671145|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671146|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671147|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671148|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671149|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671150|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671151|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671152|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671153|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671154|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671155|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671156|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671157|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671158|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671159|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671160|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671161|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671162|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671163|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
671164|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671165|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671166|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
671167|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671168|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671169|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
671170|NCT00350727|E3|Reported Event|Phase II: Biomarker Negative|All participants received pazopanib 400 mg QD and lapatinib 1000 mg QD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
671171|NCT00350727|E2|Reported Event|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (QD) and lapatinib 1000 mg QD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
671172|NCT00350727|E1|Reported Event|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
671173|NCT00350636|B3|Baseline|Total|Total of all reporting groups
671174|NCT00350636|B2|Baseline|Placebo Topical Gel|1 g placebo topical gel
671175|NCT00350636|B1|Baseline|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671176|NCT00350636|P2|Participant Flow|Placebo Topical Gel|1 g placebo topical gel
671177|NCT00350636|P1|Participant Flow|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671178|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
671179|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671180|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
671181|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671182|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
671183|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671184|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
671185|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671186|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
671187|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671188|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
671189|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671190|NCT00350636|E2|Reported Event|Placebo Topical Gel|1 g placebo topical gel
671191|NCT00350636|E1|Reported Event|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
671192|NCT00350623|B4|Baseline|Total|Total of all reporting groups
671193|NCT00350623|B3|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671194|NCT00350623|B2|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671195|NCT00350623|B1|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671196|NCT00350623|P3|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671197|NCT00350623|P2|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671198|NCT00350623|P1|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671199|NCT00350623|O3|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671200|NCT00350623|O2|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671201|NCT00350623|O1|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671202|NCT00350623|E3|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671203|NCT00350623|E2|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671204|NCT00350623|E1|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
671205|NCT00350545|B1|Baseline|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
671206|NCT00350545|P1|Participant Flow|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
671207|NCT00350545|O1|Outcome|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
671208|NCT00350545|O1|Outcome|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
671209|NCT00350545|O1|Outcome|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
671210|NCT00350545|O1|Outcome|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
671211|NCT00350545|O1|Outcome|Rituximab + Prednisone Arm|To determine the efficacy of Rituximab as first line of treatment of chronic GVHD.
671212|NCT00350545|E1|Reported Event|Rituximab + Prednisone Arm|"Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered.~Rituximab: 375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9~Prednisone: 1 mg/kg; po per day with taper~Cyclosporine A: trough 200-300 or lower; po~tacrolimus: trough 5-10 or lower; po"
671213|NCT00350532|B3|Baseline|Total|Total of all reporting groups
671214|NCT00350532|B2|Baseline|Healthy Subjects|Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
671215|NCT00350532|B1|Baseline|Neuropathic Pain Subjects|Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
671216|NCT00350532|P2|Participant Flow|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
671217|NCT00350532|P1|Participant Flow|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
671218|NCT00350532|O2|Outcome|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
671219|NCT00350532|O1|Outcome|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
671220|NCT00350532|E2|Reported Event|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
671221|NCT00350532|E1|Reported Event|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
671222|NCT00350519|B3|Baseline|Total|Total of all reporting groups
671223|NCT00350519|B2|Baseline|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
671224|NCT00350519|B1|Baseline|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
671225|NCT00350519|P2|Participant Flow|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
671226|NCT00350519|P1|Participant Flow|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
671227|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
671228|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
671229|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
671230|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
671231|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
671232|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
671233|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
671234|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
671235|NCT00350519|E2|Reported Event|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
671325|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671236|NCT00350519|E1|Reported Event|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
671237|NCT00350402|B3|Baseline|Total|Total of all reporting groups
671238|NCT00350402|B2|Baseline|Sham MST|Low intensity muscle strength training (5% MIP)
671239|NCT00350402|B1|Baseline|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
671240|NCT00350402|P2|Participant Flow|Sham MST|Low intensity muscle strength training (5% MIP)
671241|NCT00350402|P1|Participant Flow|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
671242|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"This intervention is identical in all ways to real treatment, except that training device requires less inspiratory effort. The training device is set at 5% MIP. )"
671243|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|Same as previously described. This intervention involves high intensity respiratory muscle strength training over 4 week period, 5 days a week, with training device set at 75% maximal inspiratory pressure (MIP). The MIP is determined weekly and the training device recalibrated to take into account changes.
671244|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|Low intensity muscle strength training (5% MIP)
671245|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|high intensity respiratory muscle strength training, 75% MIP
671246|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"Same as previously described. The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
671247|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"Same as previously described. High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
671248|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
671249|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
671250|NCT00350402|E2|Reported Event|Sham MST|Low intensity muscle strength training (5% MIP)
671251|NCT00350402|E1|Reported Event|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
671252|NCT00350363|B1|Baseline|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
671253|NCT00350363|P1|Participant Flow|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
671254|NCT00350363|O1|Outcome|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
671255|NCT00350363|E1|Reported Event|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
671256|NCT00350272|B3|Baseline|Total|Total of all reporting groups
671257|NCT00350272|B2|Baseline|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671258|NCT00350272|B1|Baseline|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671259|NCT00350272|P2|Participant Flow|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671260|NCT00350272|P1|Participant Flow|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671261|NCT00350272|O2|Outcome|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671262|NCT00350272|O1|Outcome|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671263|NCT00350272|O2|Outcome|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671264|NCT00350272|O1|Outcome|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671326|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671327|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671265|NCT00350272|E2|Reported Event|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671266|NCT00350272|E1|Reported Event|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
671267|NCT00350220|B3|Baseline|Total|Total of all reporting groups
671268|NCT00350220|B2|Baseline|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
671269|NCT00350220|B1|Baseline|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
671270|NCT00350220|P2|Participant Flow|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
671271|NCT00350220|P1|Participant Flow|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
671272|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
671273|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
671274|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
671275|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
671276|NCT00350220|E2|Reported Event|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
671277|NCT00350220|E1|Reported Event|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
671278|NCT00350207|B4|Baseline|Total|Total of all reporting groups
671279|NCT00350207|B3|Baseline|Placebo|Matching Placebo
671280|NCT00350207|B2|Baseline|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671281|NCT00350207|B1|Baseline|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671282|NCT00350207|P3|Participant Flow|Placebo|Matching Placebo
671283|NCT00350207|P2|Participant Flow|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671284|NCT00350207|P1|Participant Flow|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671285|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671286|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671287|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671288|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671289|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671290|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671291|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671292|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671293|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671294|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671295|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671296|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671297|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671298|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671299|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671300|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671301|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671302|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671303|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671304|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671305|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671306|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671307|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671308|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671309|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671310|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671311|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671312|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671313|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671314|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671315|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671316|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671317|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671318|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671319|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671320|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671321|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671322|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671323|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671324|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671328|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671329|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671330|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671331|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671332|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671333|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671334|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671335|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671336|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671337|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671338|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671339|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671340|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671341|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671342|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671343|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671344|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671345|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671346|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671347|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671348|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671349|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671350|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671351|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671352|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671353|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671354|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671355|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671356|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671357|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671358|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671359|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671360|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671361|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671362|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671363|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671364|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671365|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671366|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671367|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671368|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671369|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671370|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671371|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671372|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671373|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671374|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671375|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671376|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671377|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671378|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671379|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671380|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671381|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671382|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671383|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671384|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671385|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671386|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671387|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671388|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671389|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671390|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671391|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671392|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671393|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671394|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671395|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671396|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671397|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671398|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671399|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671400|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671401|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671402|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671403|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671404|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671405|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671406|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671407|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671408|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671409|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671410|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671411|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671412|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671413|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671414|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671415|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671416|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671417|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671418|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671419|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671420|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671421|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671422|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671423|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671424|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671425|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671426|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671427|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671428|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671429|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671430|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671431|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671432|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671433|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671434|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671435|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671436|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671437|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671438|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671439|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671440|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671441|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671442|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671443|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671444|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671445|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671446|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671447|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671448|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671449|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671450|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671451|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671452|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671453|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671454|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671455|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671456|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671457|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671458|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671459|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671460|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671461|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671462|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671463|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671464|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671465|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671466|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671467|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671468|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671469|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671470|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671471|NCT00350207|O3|Outcome|Placebo|Matching Placebo
671472|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671473|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671474|NCT00350207|E3|Reported Event|Placebo|Matching Placebo
671475|NCT00350207|E2|Reported Event|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
671476|NCT00350207|E1|Reported Event|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
671477|NCT00350142|B1|Baseline|SBRT|25 Gy single fraction dose using Trilogy linear accelerator
671478|NCT00350142|P1|Participant Flow|Stereotactic Body Radiotherapy|"patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes.~Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months."
671479|NCT00350142|O1|Outcome|Stereotactic Body Radiotherapy|"single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine~Stereotactic Body Radiotherapy: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator~Gemcitabine: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes"
671480|NCT00350142|O1|Outcome|Stereotactic Radiosurgery|patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine
671481|NCT00350142|E1|Reported Event|SBRT With Gem|patient with locally advanced pancreas cancer receiving Gem + SBRT
671482|NCT00350025|B3|Baseline|Total|Total of all reporting groups
671483|NCT00350025|B2|Baseline|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
671484|NCT00350025|B1|Baseline|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
671485|NCT00350025|P2|Participant Flow|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
671486|NCT00350025|P1|Participant Flow|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
671487|NCT00350025|O2|Outcome|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
671488|NCT00350025|O1|Outcome|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
671489|NCT00350025|O2|Outcome|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
671490|NCT00350025|O1|Outcome|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
671491|NCT00350025|E2|Reported Event|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
671492|NCT00350025|E1|Reported Event|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
671493|NCT00349921|B5|Baseline|Total|Total of all reporting groups
671494|NCT00349921|B4|Baseline|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
671495|NCT00349921|B3|Baseline|Clonidine Given First, Then Placebo|clonidine given first placebo given in second injection
671496|NCT00349921|B2|Baseline|Adenosine Given First, Then Clonidine|adenosine given in first injection clonidine given in second injection
671497|NCT00349921|B1|Baseline|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
671498|NCT00349921|P4|Participant Flow|Adenosine First, Then Placebo|Adenosine given during the first period and placebo given during the second
671499|NCT00349921|P3|Participant Flow|Clonidine First, Then Placebo|Clonidine given as during the first period, then placebo during the second
671500|NCT00349921|P2|Participant Flow|Adenosine First, Then Clonidine|Adenosine given during the first period and adenosine given during the second
671501|NCT00349921|P1|Participant Flow|Clonidine First, Then Adenosine|Clonidine given during the first period and adenosine given during the second period
671502|NCT00349921|O3|Outcome|Placebo|Placebo received as either first or second injection
671503|NCT00349921|O2|Outcome|Adenosine|Adenosine received as either first or second injection
671504|NCT00349921|O1|Outcome|Clonidine|clonidine received as either first or second injection
671505|NCT00349921|E4|Reported Event|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
671506|NCT00349921|E3|Reported Event|Clonidine First, Then Placebo|clonidine given first placebo given in second injection
671507|NCT00349921|E2|Reported Event|Adenosine First, Then Clonidine|adenosine given in first injection clonidine given in second injection
671508|NCT00349921|E1|Reported Event|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
671509|NCT00349908|B3|Baseline|Total|Total of all reporting groups
671510|NCT00349908|B2|Baseline|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
671511|NCT00349908|B1|Baseline|Aneurysm Arm|Intracranial wide-necked aneurysms
671512|NCT00349908|P2|Participant Flow|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
671513|NCT00349908|P1|Participant Flow|Aneurysm Arm|Intracranial wide-necked aneurysms
671514|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
671515|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
671516|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
671517|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
671518|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
671519|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
671520|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
671521|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
671522|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
671528|NCT00349908|E2|Reported Event|Group 2: Aneurysm Arm|This is the events from the Aneurysm Arm
671529|NCT00349908|E1|Reported Event|Group 1: Atherosclerosis Arm|This is the events from the Atherosclerosis Arm
671530|NCT00349778|B1|Baseline|High-Dose Sequential Therapy|Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
671531|NCT00349778|P1|Participant Flow|High-Dose Sequential Therapy|Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
671532|NCT00349778|O1|Outcome|High-Dose Sequential Therapy|Cyclophosphamide + etoposide + melphalan + carmustine with filgrastim
671533|NCT00349778|O1|Outcome|High-Dose Sequential Therapy|Cyclophosphamide + etoposide + melphalan + carmustine with filgrastim
671534|NCT00349778|O1|Outcome|High-Dose Sequential Therapy|Cyclophosphamide + etoposide + melphalan + carmustine with filgrastim
671535|NCT00349778|E1|Reported Event|High-Dose Sequential Therapy|Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
671536|NCT00349752|B3|Baseline|Total|Total of all reporting groups
671537|NCT00349752|B2|Baseline|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671538|NCT00349752|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671539|NCT00349752|P2|Participant Flow|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671540|NCT00349752|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671541|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671542|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671543|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671544|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671545|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671546|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671547|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671548|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671549|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671550|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671551|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671552|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671553|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671554|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671555|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671556|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671557|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671558|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671559|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671560|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671561|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671562|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671563|NCT00349752|E2|Reported Event|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671734|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
671564|NCT00349752|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
671565|NCT00349713|B4|Baseline|Total|Total of all reporting groups
671566|NCT00349713|B3|Baseline|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
671567|NCT00349713|B2|Baseline|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671568|NCT00349713|B1|Baseline|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671569|NCT00349713|P3|Participant Flow|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
671570|NCT00349713|P2|Participant Flow|Cohort 2: FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671571|NCT00349713|P1|Participant Flow|Cohort 1: FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671572|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
671573|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671574|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671575|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
671576|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671577|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671578|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
671579|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671580|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671581|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
671582|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671583|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671584|NCT00349713|O3|Outcome|Cohorts 1 and 2: Rabies Vaccine (RabAvert)|"20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2~Rabies vaccine (RabAvert): RabAvert Rabies vaccine"
671585|NCT00349713|O2|Outcome|Cohort 2: 50ug FMP2.1 / AS02A|"20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671586|NCT00349713|O1|Outcome|Cohort 1: 25ug FMP2.1 / AS02A|"20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A~FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A"
671587|NCT00349713|E3|Reported Event|Cohort 3: Rabies Vaccine (RabAvert)|Rabies vaccine, All events reports instead of AE's per vaccination group 20 subjects (10 from Cohort 1 and 10 from Cohort 2)
671588|NCT00349713|E2|Reported Event|Cohort 2: 50 ug FMP2.1 / AS02A|50 ug FMP2.1 / AS02A
671589|NCT00349713|E1|Reported Event|Cohort 1: 25 ug FMP2.1 / AS02|25 ug FMPs.1 / AS02
671590|NCT00349622|B3|Baseline|Total|Total of all reporting groups
671591|NCT00349622|B2|Baseline|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671592|NCT00349622|B1|Baseline|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671593|NCT00349622|P2|Participant Flow|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671594|NCT00349622|P1|Participant Flow|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671595|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
672154|NCT00347776|E2|Reported Event|Intervention|"The two azithromycin groups combined~Antibiotic: Oral Azithromycin"
671596|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671597|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671598|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671599|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671600|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671601|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671602|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671603|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671604|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671605|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671606|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671607|NCT00349622|E2|Reported Event|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
671608|NCT00349622|E1|Reported Event|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
671609|NCT00349466|B3|Baseline|Total|Total of all reporting groups
671610|NCT00349466|B2|Baseline|Placebo|Placebo tablets q12 hours for 12 weeks
671611|NCT00349466|B1|Baseline|CF101 1 mg|CF101 1 mg q12 hours
671612|NCT00349466|P2|Participant Flow|Placebo|Placebo tablets q12 hours for 12 weeks
671613|NCT00349466|P1|Participant Flow|CF101 1 mg|CF101 1 mg q12 hours
671614|NCT00349466|O2|Outcome|Placebo BID|Oral tablets given every 12 hours for 12 weeks
671615|NCT00349466|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
671616|NCT00349466|E2|Reported Event|Placebo|Placebo tablets q12 hours for 12 weeks
671617|NCT00349466|E1|Reported Event|CF101 1 mg|CF101 1 mg q12 hours
671618|NCT00349388|B3|Baseline|Total|Total of all reporting groups
671619|NCT00349388|B2|Baseline|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
671620|NCT00349388|B1|Baseline|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
671621|NCT00349388|P2|Participant Flow|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
671622|NCT00349388|P1|Participant Flow|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
671623|NCT00349388|O2|Outcome|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
671624|NCT00349388|O1|Outcome|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
671625|NCT00349388|E2|Reported Event|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
671626|NCT00349388|E1|Reported Event|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
671627|NCT00349349|B4|Baseline|Total|Total of all reporting groups
671987|NCT00348283|E2|Reported Event|Adalimumab|All subjects (135 subjects) enrolled in the study received adalimumab 160 mg at Baseline followed by adalimumab 80 mg at Week 2 (Induction dose).
671628|NCT00349349|B3|Baseline|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671629|NCT00349349|B2|Baseline|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671630|NCT00349349|B1|Baseline|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671631|NCT00349349|P3|Participant Flow|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671632|NCT00349349|P2|Participant Flow|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671633|NCT00349349|P1|Participant Flow|2000 mg Ofatumumab + DR|Ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The independent endpoint review committee (IRC) classified these participants as double refractory (DR), defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671634|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
671635|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
671636|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
671637|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined
671638|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
671639|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671640|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671641|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671642|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671643|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671644|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671645|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671646|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671647|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671735|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
671648|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671649|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671650|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671651|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671652|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671653|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671654|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671655|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671656|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671657|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671658|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671659|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671660|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671661|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671662|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671663|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671664|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671665|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671666|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671667|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671668|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671669|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671670|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671671|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671672|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671673|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671674|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671675|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671676|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671677|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671678|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671679|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671680|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671681|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671682|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671683|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671684|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671685|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671686|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671687|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671688|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671689|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671690|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671691|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671692|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671693|NCT00349349|E3|Reported Event|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
671694|NCT00349349|E2|Reported Event|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
671695|NCT00349349|E1|Reported Event|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
671696|NCT00349336|B3|Baseline|Total|Total of all reporting groups
671697|NCT00349336|B2|Baseline|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671698|NCT00349336|B1|Baseline|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671699|NCT00349336|P2|Participant Flow|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671700|NCT00349336|P1|Participant Flow|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671701|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671702|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671703|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671704|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671705|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671706|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671707|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671988|NCT00348283|E1|Reported Event|Placebo|
671989|NCT00348140|B4|Baseline|Total|Total of all reporting groups
671708|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671709|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671710|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671711|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671712|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671713|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671714|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671715|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671716|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671717|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671718|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671719|NCT00349336|E2|Reported Event|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
671720|NCT00349336|E1|Reported Event|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
671721|NCT00348933|B1|Baseline|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
671722|NCT00348933|P1|Participant Flow|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
671723|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
671724|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betain/B12)|All participants received treatment. Compared to a placebo group from a previous study.
671725|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
671726|NCT00348933|E1|Reported Event|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
671727|NCT00348881|B3|Baseline|Total|Total of all reporting groups
671728|NCT00348881|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
671729|NCT00348881|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
671730|NCT00348881|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
671731|NCT00348881|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
671732|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
671733|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
672155|NCT00347776|E1|Reported Event|Control|"Topical tetracycline~Antibiotic:Topical tetracycline"
671736|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/Hib™ Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
671737|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
671738|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
671739|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
671740|NCT00348881|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
671741|NCT00348881|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
671742|NCT00348816|B1|Baseline|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
671743|NCT00348816|P1|Participant Flow|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
671744|NCT00348816|O1|Outcome|Correlation Between Velocity of Subsequent PSA Failure and Sur|All study completers
671745|NCT00348816|O1|Outcome|Overall Survival|N/A, no data for overall survival recorded
671746|NCT00348816|O1|Outcome|Docetaxel (Single Arm)|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
671747|NCT00348816|O1|Outcome|Docetaxel (Single Arm)|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
671748|NCT00348816|E1|Reported Event|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
671749|NCT00348790|B1|Baseline|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
671750|NCT00348790|P1|Participant Flow|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
671751|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
671752|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
671753|NCT00348790|E1|Reported Event|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months.~vatalanib"
671754|NCT00348686|B1|Baseline|Candesartan|
671755|NCT00348686|P1|Participant Flow|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
671756|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
671757|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
672328|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
671758|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
671759|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
671760|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
671761|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
671762|NCT00348686|E1|Reported Event|Candesartan|
671763|NCT00348673|B9|Baseline|Total|Total of all reporting groups
671764|NCT00348673|B8|Baseline|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671765|NCT00348673|B7|Baseline|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
671766|NCT00348673|B6|Baseline|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671767|NCT00348673|B5|Baseline|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671768|NCT00348673|B4|Baseline|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671769|NCT00348673|B3|Baseline|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671770|NCT00348673|B2|Baseline|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671771|NCT00348673|B1|Baseline|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671772|NCT00348673|P9|Participant Flow|Placebo Once/Twice Daily (Stage 2)|Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671773|NCT00348673|P8|Participant Flow|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
671774|NCT00348673|P7|Participant Flow|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671775|NCT00348673|P6|Participant Flow|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671776|NCT00348673|P5|Participant Flow|Placebo Once/Twice Daily (Stage 1)|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671777|NCT00348673|P4|Participant Flow|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671778|NCT00348673|P3|Participant Flow|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671779|NCT00348673|P2|Participant Flow|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671780|NCT00348673|P1|Participant Flow|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671781|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
671782|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671783|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671784|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671785|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671786|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671787|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671788|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
672101|NCT00347932|B1|Baseline|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
671789|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671790|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671791|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671792|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671793|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671794|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671795|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
671796|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671797|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671798|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671799|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671800|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671801|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671802|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671803|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
671804|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671805|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671806|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671807|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671808|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671809|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671810|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671811|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
671812|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671813|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671814|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671815|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671816|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671817|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671818|NCT00348673|E8|Reported Event|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671819|NCT00348673|E7|Reported Event|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
672156|NCT00347438|B1|Baseline|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
671820|NCT00348673|E6|Reported Event|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
671821|NCT00348673|E5|Reported Event|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
671822|NCT00348673|E4|Reported Event|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
671823|NCT00348673|E3|Reported Event|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671824|NCT00348673|E2|Reported Event|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671825|NCT00348673|E1|Reported Event|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
671826|NCT00348556|B1|Baseline|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
671827|NCT00348556|P1|Participant Flow|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
671828|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
671829|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
671830|NCT00348556|E1|Reported Event|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
671831|NCT00348374|B3|Baseline|Total|Total of all reporting groups
671832|NCT00348374|B2|Baseline|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671833|NCT00348374|B1|Baseline|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671834|NCT00348374|P2|Participant Flow|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671835|NCT00348374|P1|Participant Flow|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671836|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671837|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671838|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671839|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671840|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671841|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671911|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671842|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671843|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671844|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671845|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671846|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671847|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671848|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671849|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671850|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671851|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671852|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
671853|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671854|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671855|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671856|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671857|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671858|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671859|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671860|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671861|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671862|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671863|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671864|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671865|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671866|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671867|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671868|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671869|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671870|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671871|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671872|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671873|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671874|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671912|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671875|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671876|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671877|NCT00348374|E2|Reported Event|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
671878|NCT00348374|E1|Reported Event|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
671879|NCT00348348|B3|Baseline|Total|Total of all reporting groups
671880|NCT00348348|B2|Baseline|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
671881|NCT00348348|B1|Baseline|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
671882|NCT00348348|P2|Participant Flow|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
671883|NCT00348348|P1|Participant Flow|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
671884|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
671885|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
671886|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
671887|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
671888|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
671889|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
671890|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
671891|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
671892|NCT00348348|E2|Reported Event|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
671893|NCT00348348|E1|Reported Event|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
671894|NCT00348309|B4|Baseline|Total|Total of all reporting groups
671895|NCT00348309|B3|Baseline|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671896|NCT00348309|B2|Baseline|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671897|NCT00348309|B1|Baseline|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671898|NCT00348309|P3|Participant Flow|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671899|NCT00348309|P2|Participant Flow|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671900|NCT00348309|P1|Participant Flow|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671901|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671902|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671903|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671904|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671905|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671906|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671907|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671908|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671909|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671910|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671913|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671914|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671915|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671916|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671917|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671918|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671919|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671920|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671921|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671922|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671923|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671924|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671925|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671926|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671927|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671928|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671929|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671930|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671931|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671932|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671933|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671934|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671935|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671936|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671937|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671938|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671939|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671940|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671941|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671942|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671943|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671983|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
671984|NCT00348283|O1|Outcome|Placebo|
671944|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671945|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671946|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671947|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671948|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671949|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671950|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671951|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671952|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671953|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671954|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671955|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671956|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671957|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671958|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671959|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671960|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671961|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671962|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671963|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671964|NCT00348309|O3|Outcome|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671965|NCT00348309|O2|Outcome|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671966|NCT00348309|O1|Outcome|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671967|NCT00348309|E3|Reported Event|8mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
671968|NCT00348309|E2|Reported Event|2mg Rosiglitazone Extended Release|Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
671969|NCT00348309|E1|Reported Event|Placebo|Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
671970|NCT00348283|B3|Baseline|Total|Total of all reporting groups
671971|NCT00348283|B2|Baseline|Adalimumab 40 mg Every Other Week|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
671972|NCT00348283|B1|Baseline|Placebo|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
671973|NCT00348283|P2|Participant Flow|Adalimumab|40 mg SC eow
671974|NCT00348283|P1|Participant Flow|Placebo|SC dosing eow
671975|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
671976|NCT00348283|O1|Outcome|Placebo|
671977|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
671978|NCT00348283|O1|Outcome|Placebo|
671979|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
671980|NCT00348283|O1|Outcome|Placebo|
671981|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
671982|NCT00348283|O1|Outcome|Placebo|
671990|NCT00348140|B3|Baseline|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
671991|NCT00348140|B2|Baseline|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
671992|NCT00348140|B1|Baseline|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
671993|NCT00348140|P3|Participant Flow|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
671994|NCT00348140|P2|Participant Flow|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 milligrams (mg) once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
671995|NCT00348140|P1|Participant Flow|Placebo|Participants randomized to this arm received matching Rosiglitazone extended release (RSG XR) placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
671996|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
671997|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
671998|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
671999|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672000|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672001|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672002|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672003|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received Rosiglitazone 2 mg in the form of extended release (XR) once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672004|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672005|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672006|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672007|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672008|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672009|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672010|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672102|NCT00347932|P2|Participant Flow|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672011|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672012|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672013|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672014|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672015|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672016|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672017|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672018|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672019|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672020|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672021|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672022|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672023|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672024|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672025|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672026|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672027|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672028|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672029|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672030|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672031|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672097|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
672032|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672033|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672034|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672035|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672036|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672037|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672038|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672039|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672040|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672041|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672042|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672043|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672044|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672045|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672046|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672047|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672048|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672049|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672050|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672051|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672052|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672098|NCT00347958|E1|Reported Event|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
672099|NCT00347932|B3|Baseline|Total|Total of all reporting groups
672053|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672054|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672055|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672056|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672057|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672058|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672059|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672060|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672061|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672062|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672063|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672064|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672065|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672066|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672067|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672068|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672069|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672070|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672071|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672072|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672073|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672100|NCT00347932|B2|Baseline|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672152|NCT00347776|O2|Outcome|Intervention|"The two azithromycin groups combined~Antibiotic: Oral Azithromycin"
672074|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672075|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672076|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672077|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672078|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672079|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672080|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672081|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672082|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672083|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672084|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672085|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672086|NCT00348140|O3|Outcome|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672087|NCT00348140|O2|Outcome|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672088|NCT00348140|O1|Outcome|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672089|NCT00348140|E3|Reported Event|RSG XR 8mg|Participants randomized to this arm received RSG XR 8 mg one 4mg tablet once daily for the first 4 weeks of treatment. From Visit 3 (Week 4) onwards, these participants received one 8mg tablet once daily for the remaining 44 weeks of double-blind treatment. From Week 48 all participants received single-blind placebo treatment as one tablet daily, until Visit 10 (Week 54)
672090|NCT00348140|E2|Reported Event|RSG XR 2mg|Participants randomized to this arm received RSG XR 2 mg once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672091|NCT00348140|E1|Reported Event|Placebo|Participants randomized to this arm received matching RSG XR placebo tablets once daily which remained constant throughout the 48 Week treatment period. From Week 48 all the participants received single-blind placebo treatment as one tablet daily until Visit 10 (Week 54)
672092|NCT00347958|B1|Baseline|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
672093|NCT00347958|P1|Participant Flow|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
672094|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
672095|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
672096|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
672153|NCT00347776|O1|Outcome|Control|"Topical tetracycline~Antibiotic:Topical tetracycline"
672103|NCT00347932|P1|Participant Flow|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672104|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672105|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672106|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672107|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672108|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672109|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672110|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672111|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672112|NCT00347932|E2|Reported Event|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672113|NCT00347932|E1|Reported Event|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
672114|NCT00347919|B4|Baseline|Total|Total of all reporting groups
672115|NCT00347919|B3|Baseline|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672116|NCT00347919|B2|Baseline|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672117|NCT00347919|B1|Baseline|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672118|NCT00347919|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672119|NCT00347919|P2|Participant Flow|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672120|NCT00347919|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672121|NCT00347919|O1|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672122|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672123|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672124|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672125|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/ Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672126|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672127|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672128|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672129|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672130|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672131|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672132|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672133|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672134|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672135|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672136|NCT00347919|E3|Reported Event|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
672137|NCT00347919|E2|Reported Event|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
672138|NCT00347919|E1|Reported Event|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
672139|NCT00347776|B4|Baseline|Total|Total of all reporting groups
672140|NCT00347776|B3|Baseline|Intervention2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
672141|NCT00347776|B2|Baseline|Intervention1|Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
672142|NCT00347776|B1|Baseline|Control|Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
672143|NCT00347776|P3|Participant Flow|Intervention 2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
672144|NCT00347776|P2|Participant Flow|Intervention 1|Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g)
672145|NCT00347776|P1|Participant Flow|Control|Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
672146|NCT00347776|O2|Outcome|Intervention|"The two azithromycin groups combined~Antibiotic: Oral Azithromycin"
672147|NCT00347776|O1|Outcome|Control|"Topical tetracycline~Antibiotic:Topical tetracycline"
672148|NCT00347776|O2|Outcome|Intervention|"The two azithromycin groups combined~Antibiotic: Oral Azithromycin"
672149|NCT00347776|O1|Outcome|Control|"Topical tetracycline~Antibiotic:Topical tetracycline"
672150|NCT00347776|O2|Outcome|Intervention2|Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
672151|NCT00347776|O1|Outcome|Intervention1|Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
672157|NCT00347438|P1|Participant Flow|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
672158|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
672159|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
672160|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
672161|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
672162|NCT00347438|E1|Reported Event|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
672163|NCT00347360|B16|Baseline|Total|Total of all reporting groups
672164|NCT00347360|B15|Baseline|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672165|NCT00347360|B14|Baseline|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672166|NCT00347360|B13|Baseline|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672167|NCT00347360|B12|Baseline|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672168|NCT00347360|B11|Baseline|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672169|NCT00347360|B10|Baseline|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672170|NCT00347360|B9|Baseline|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672171|NCT00347360|B8|Baseline|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672172|NCT00347360|B7|Baseline|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672173|NCT00347360|B6|Baseline|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672174|NCT00347360|B5|Baseline|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672175|NCT00347360|B4|Baseline|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672176|NCT00347360|B3|Baseline|Lisinopril 40|lisinopril 40 mg once daily
672177|NCT00347360|B2|Baseline|Lisinopril 20|lisinopril 20 mg once daily
672178|NCT00347360|B1|Baseline|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672179|NCT00347360|P15|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672180|NCT00347360|P14|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672181|NCT00347360|P13|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672182|NCT00347360|P12|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672183|NCT00347360|P11|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672184|NCT00347360|P10|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672185|NCT00347360|P9|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672186|NCT00347360|P8|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672187|NCT00347360|P7|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672188|NCT00347360|P6|Participant Flow|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672189|NCT00347360|P5|Participant Flow|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672190|NCT00347360|P4|Participant Flow|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672191|NCT00347360|P3|Participant Flow|Lisinopril 40|lisinopril 40 mg once daily
672192|NCT00347360|P2|Participant Flow|Lisinopril 20|lisinopril 20 mg once daily
672193|NCT00347360|P1|Participant Flow|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672194|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672195|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672196|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672197|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672198|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672199|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672200|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672201|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672202|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672203|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672204|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672205|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672206|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672207|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672208|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672209|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672210|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672211|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672212|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672213|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672214|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672215|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672216|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672217|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672218|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672219|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672220|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672221|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672222|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672223|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672224|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672225|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672226|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672227|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672228|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672229|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672230|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672231|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672232|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672233|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672234|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672235|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672236|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672237|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672238|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672239|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672240|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672241|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672242|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672243|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672244|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672245|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672246|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672247|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672248|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672249|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672250|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672251|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672252|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672253|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672254|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672255|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672256|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672257|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672258|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672259|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672260|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672261|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672262|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672263|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672264|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672265|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672266|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672267|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672268|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672269|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672270|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672271|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672272|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672273|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672274|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672275|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672276|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672277|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672278|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672279|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672280|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672281|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672282|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672283|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672284|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672285|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672286|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672287|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672288|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672289|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672290|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672291|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672292|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672293|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672294|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672295|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672296|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672297|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672298|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672299|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672300|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672301|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672302|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672303|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672304|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672305|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672306|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672307|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672308|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672309|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672310|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672311|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672312|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672313|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672314|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672315|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672316|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672317|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672318|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672319|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672320|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672321|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672322|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672323|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672324|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672325|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672326|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672327|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672329|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672330|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672331|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672332|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672333|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672334|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672335|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672336|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672337|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672338|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672339|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672340|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672341|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672342|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672343|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672344|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672345|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672346|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672347|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672348|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672349|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672350|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672351|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672352|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672353|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672354|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672355|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672356|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
672357|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
672358|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672359|NCT00347360|E15|Reported Event|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
672360|NCT00347360|E14|Reported Event|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
672361|NCT00347360|E13|Reported Event|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
672362|NCT00347360|E12|Reported Event|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
672363|NCT00347360|E11|Reported Event|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
672364|NCT00347360|E10|Reported Event|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
672365|NCT00347360|E9|Reported Event|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
672366|NCT00347360|E8|Reported Event|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
672367|NCT00347360|E7|Reported Event|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
672368|NCT00347360|E6|Reported Event|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
672369|NCT00347360|E5|Reported Event|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
672370|NCT00347360|E4|Reported Event|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
672371|NCT00347360|E3|Reported Event|Lisinopril 40|lisinopril 40 mg once daily
672372|NCT00347360|E2|Reported Event|Lisinopril 20|lisinopril 20 mg once daily
672373|NCT00347360|E1|Reported Event|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
672374|NCT00347308|B1|Baseline|Group 1|All patients entered into the study
672375|NCT00347308|P1|Participant Flow|Group 1|All patients entered into the study
672376|NCT00347308|O1|Outcome|Group 1|All patients entered into the study
672377|NCT00347308|E1|Reported Event|Group 1|All patients entered into the study
672378|NCT00347269|B3|Baseline|Total|Total of all reporting groups
672379|NCT00347269|B2|Baseline|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
672380|NCT00347269|B1|Baseline|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
672519|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
672381|NCT00347269|P2|Participant Flow|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
672382|NCT00347269|P1|Participant Flow|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
672383|NCT00347269|O2|Outcome|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
672384|NCT00347269|O1|Outcome|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
672385|NCT00347269|E2|Reported Event|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
672386|NCT00347269|E1|Reported Event|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
672387|NCT00347022|B3|Baseline|Total|Total of all reporting groups
672388|NCT00347022|B2|Baseline|Visipaque|Patient will be injected with Visipaque 270
672389|NCT00347022|B1|Baseline|Xenetix|Patient will be injected with Xenetix 300
672390|NCT00347022|P2|Participant Flow|Visipaque|Patient will receive one injection of Visipaque 270
672391|NCT00347022|P1|Participant Flow|Xenetix|Patient will receive one injection of Xenetix 300
672392|NCT00347022|O2|Outcome|Visipaque|Patient will receive one injection of Visipaque 270
672393|NCT00347022|O1|Outcome|Xenetix|Patient will receive one injection of Xenetix 300
672394|NCT00347022|E2|Reported Event|Vispaque|Patient will be injected with Visipaque 270
672395|NCT00347022|E1|Reported Event|Xenetix|Patient will be injected with Xenetix 300
672396|NCT00347009|B1|Baseline|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672397|NCT00347009|P1|Participant Flow|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672398|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672399|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672400|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672401|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672402|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672403|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672404|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672405|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672406|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672407|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672408|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672409|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672410|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672411|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672412|NCT00347009|E1|Reported Event|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
672413|NCT00346905|B1|Baseline|Group 1|Patients experiencing moderate GERD
672414|NCT00346905|P1|Participant Flow|Group 1|Patients that are GERD responsive and requiring daily PPI therapy
672415|NCT00346905|O1|Outcome|Enteryx Treatment|"Those receiving Enteryx treatment~Enteryx"
672416|NCT00346905|E1|Reported Event|Group 1 - Single Arm|Those experiencing GERD
672417|NCT00346775|B1|Baseline|Beconase + Nasarel|Participants were administered 168 µg Beconase AQ or 116 µg Nasarel metered dose nasal spray twice daily for 1 week in a sequence of Beconase /Nasarel or Nasarel/Beconase according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
672418|NCT00346775|P2|Participant Flow|Nasarel Then Beconase|Participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week. After a washout period of 7 days, participants were administered 168 µg Beconase AQ, metered dose nasal spray twice daily for 1 week.
672419|NCT00346775|P1|Participant Flow|Beconase Then Nasarel|Participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week. After a washout period of 7 days, participants were administered 116 µg Nasarel, metered dose nasal spray twice daily for 1 week.
672520|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
672420|NCT00346775|O2|Outcome|Nasarel|In each period of the study, participants were administered 116 μg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
672421|NCT00346775|O1|Outcome|Beconase|In each period of the study, participants were administered 168 μg Beconase AQ metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
672422|NCT00346775|O2|Outcome|Nasarel|In each period of the study, participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
672423|NCT00346775|O1|Outcome|Beconase|In each period of the study, participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
672424|NCT00346775|O1|Outcome|Beconase + Nasarel|Participants were administered 168 µg Beconase AQ or 116 µg Nasarel metered dose nasal spray twice daily for 1 week in a sequence of Beconase /Nasarel or Nasarel/Beconase according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. After completing TP2, at Visit 5 (Day 22), participants were administered the Preference Module of the EARNS-Q. The Experience Module of EARNS-Q questionnaire was administered on Visit 2 (Day 1) of each TP. The validity of the Preference Module of the EARNS-Q was assessed by the correlation analysis with change scores (score of TP2 minus scores of TP1) of the Experience Module of EARNS-Q questionnaire. Because study medication was changed only once, there was only one assessment of the Preference Module of the EARNS-Q.
672425|NCT00346775|O1|Outcome|Beconase + Nasarel|Participants were administered 168 µg Beconase AQ or 116 µg Nasarel metered dose nasal spray twice daily for 1 week in a sequence of Beconase /Nasarel or Nasarel/Beconase according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days. After completing TP2, at Visit 5 (Day 22), participants were administered the Preference Module of the EARNS-Q. The TSQM questionnaire was administered to participants at Visits 3 (Day 8) after completion of TP1 and on Visit 5 (Day 22), after completion of TP2. The validity of the Preference Module of the EARNS-Q was assessed by the correlation analysis with change scores (score of TP2 minus scores of TP1) of TSQM questionnaire and rTNSS. Because study medication was changed only once, there was only one assessment of the Preference Module of the EARNS-Q.
672426|NCT00346775|E2|Reported Event|Nasarel|In each period of the study, participants were administered 116 µg Nasarel metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
672427|NCT00346775|E1|Reported Event|Beconase|In each period of the study, participants were administered 168 µg Beconase AQ metered dose nasal spray twice daily for 1 week according to a plan of randomization. The two treatment periods were separated by a washout period of 7 days.
672428|NCT00346697|B3|Baseline|Total|Total of all reporting groups
672429|NCT00346697|B2|Baseline|Placebo|Corn oil placebo, plus dietary counselling
672430|NCT00346697|B1|Baseline|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672431|NCT00346697|P2|Participant Flow|Placebo|Corn oil placebo, plus dietary counselling
672432|NCT00346697|P1|Participant Flow|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672433|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672434|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672435|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672436|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672437|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672438|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672439|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672440|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672441|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672442|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672443|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672444|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672445|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672446|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672447|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672448|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672449|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672450|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672451|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672452|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672453|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672454|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672455|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672456|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672457|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672458|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672459|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672460|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672461|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
672462|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
672463|NCT00346697|E2|Reported Event|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672464|NCT00346697|E1|Reported Event|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
672465|NCT00346632|B3|Baseline|Total|Total of all reporting groups
672466|NCT00346632|B2|Baseline|Arm B: KW-2449 28-day Regimen|Sequential ascending oral doses of KW-2449 given for 28-day cycles
672467|NCT00346632|B1|Baseline|Arm A: KW-2449 14-day Regimen|Sequential ascending oral doses of KW-2449 given for 14-day cycles
672468|NCT00346632|P10|Participant Flow|100 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
672469|NCT00346632|P9|Participant Flow|50 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
672470|NCT00346632|P8|Participant Flow|25 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
672471|NCT00346632|P7|Participant Flow|500 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
672472|NCT00346632|P6|Participant Flow|400 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
672473|NCT00346632|P5|Participant Flow|300 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
672474|NCT00346632|P4|Participant Flow|200 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
672475|NCT00346632|P3|Participant Flow|100 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
672476|NCT00346632|P2|Participant Flow|50 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
672477|NCT00346632|P1|Participant Flow|25 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
672478|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
672479|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
672480|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
672481|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
672482|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
672483|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
672484|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
672485|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
672486|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
672487|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
672488|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
672489|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
672490|NCT00346632|O13|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
672491|NCT00346632|O12|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
672492|NCT00346632|O11|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
672493|NCT00346632|O10|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
672494|NCT00346632|O9|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
672495|NCT00346632|O8|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
672496|NCT00346632|O7|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
672497|NCT00346632|O6|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
672498|NCT00346632|O5|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
672499|NCT00346632|O4|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
672500|NCT00346632|O3|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
672501|NCT00346632|O2|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
672502|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
672503|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
672504|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
672505|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672506|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
672507|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
672508|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
672509|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
672510|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
672511|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
672512|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
672513|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
672514|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
672515|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
672516|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
672517|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
672518|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
672521|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672522|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
672523|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
672524|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
672525|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
672526|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
672527|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
672528|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672529|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
672530|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
672531|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
672532|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
672533|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
672534|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
672535|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
672536|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
672537|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
672538|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
672539|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
672540|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
672541|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
672542|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
672543|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
672544|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672545|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
672546|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
672547|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
672548|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
672549|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
672550|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
672551|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672552|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
672553|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
672554|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
672555|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
672556|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
672557|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
672558|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
672559|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
672560|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
672561|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
672562|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
672563|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
672564|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
672565|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
672566|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
672567|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672568|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
672569|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
672570|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
672571|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
672572|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
672573|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
672574|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672575|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
672576|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
672577|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
672578|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
672579|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
672580|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
672581|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
672582|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
672583|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
672584|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
672585|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
672586|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
672587|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
672588|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
672589|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
672590|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
672591|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
672592|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
672593|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
672594|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
672595|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
672596|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
672597|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
672598|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
672599|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
672600|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
672601|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
672602|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
672603|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
672604|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
672605|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
672606|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
672607|NCT00346632|E12|Reported Event|Arm B - Total|Total Patients in Treatment Arm B
672608|NCT00346632|E11|Reported Event|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
672609|NCT00346632|E10|Reported Event|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
672610|NCT00346632|E9|Reported Event|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
672611|NCT00346632|E8|Reported Event|Arm A - Total|Total Patients in Treatment Arm A
672612|NCT00346632|E7|Reported Event|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
672613|NCT00346632|E6|Reported Event|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
672614|NCT00346632|E5|Reported Event|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
672615|NCT00346632|E4|Reported Event|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
672616|NCT00346632|E3|Reported Event|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
672617|NCT00346632|E2|Reported Event|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
672618|NCT00346632|E1|Reported Event|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
672619|NCT00346476|B1|Baseline|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
672620|NCT00346476|P1|Participant Flow|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
672621|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
672622|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
672623|NCT00346476|E1|Reported Event|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
672624|NCT00346398|B3|Baseline|Total|Total of all reporting groups
672625|NCT00346398|B2|Baseline|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672626|NCT00346398|B1|Baseline|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672627|NCT00346398|P2|Participant Flow|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672628|NCT00346398|P1|Participant Flow|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672629|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672630|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
673232|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
672631|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672632|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672633|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672634|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672635|NCT00346398|E2|Reported Event|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672636|NCT00346398|E1|Reported Event|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
672637|NCT00346333|B3|Baseline|Total|Total of all reporting groups
672638|NCT00346333|B2|Baseline|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A palmitate daily
672639|NCT00346333|B1|Baseline|Control Plus Vitamin A|cornstarch control plus 15,000IU Vitamin A palmitate daily
672640|NCT00346333|P2|Participant Flow|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
672641|NCT00346333|P1|Participant Flow|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
672642|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
672643|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
672644|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
672645|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
672646|NCT00346333|O2|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
672647|NCT00346333|O1|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
672648|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
672649|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
672650|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
672651|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
672652|NCT00346333|E2|Reported Event|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A daily.
672653|NCT00346333|E1|Reported Event|Control Plus Vitamin A|Daily intake of cornstarch control plus 15,000IU Vitamin A palmitate
672654|NCT00346268|B3|Baseline|Total|Total of all reporting groups
672655|NCT00346268|B2|Baseline|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672656|NCT00346268|B1|Baseline|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672657|NCT00346268|P2|Participant Flow|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672658|NCT00346268|P1|Participant Flow|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672659|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672660|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672661|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
673233|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
672662|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672663|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672664|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672665|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672666|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672667|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672668|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672669|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672670|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672671|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672672|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672673|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672674|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672675|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672676|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672677|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672678|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672679|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672680|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672681|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672682|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672880|NCT00345631|B2|Baseline|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672683|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672684|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672685|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672686|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672687|NCT00346268|E2|Reported Event|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672688|NCT00346268|E1|Reported Event|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
672689|NCT00346216|B4|Baseline|Total|Total of all reporting groups
672690|NCT00346216|B3|Baseline|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
672691|NCT00346216|B2|Baseline|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
672692|NCT00346216|B1|Baseline|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
672693|NCT00346216|P3|Participant Flow|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
672694|NCT00346216|P2|Participant Flow|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
672695|NCT00346216|P1|Participant Flow|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
672696|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
672697|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
672698|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
672699|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
672700|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
672701|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
672702|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
672703|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
672704|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
672705|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
672706|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
672707|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
672708|NCT00346216|E3|Reported Event|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
672709|NCT00346216|E2|Reported Event|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
672710|NCT00346216|E1|Reported Event|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
672711|NCT00346164|B5|Baseline|Total|Total of all reporting groups
672712|NCT00346164|B4|Baseline|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672881|NCT00345631|B1|Baseline|Roll-In|Roll-In patients were device training patients
673581|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
672713|NCT00346164|B3|Baseline|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672714|NCT00346164|B2|Baseline|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
672715|NCT00346164|B1|Baseline|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
672716|NCT00346164|P4|Participant Flow|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672717|NCT00346164|P3|Participant Flow|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672718|NCT00346164|P2|Participant Flow|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
672719|NCT00346164|P1|Participant Flow|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
672720|NCT00346164|O3|Outcome|Histologic Grade 3 by FNCLCC|
672721|NCT00346164|O2|Outcome|Histologic Grade 2 by FNCLCC|
672722|NCT00346164|O1|Outcome|Histologic Grade 1 by FNCLCC|
672723|NCT00346164|O3|Outcome|Histologic Grade 3 by Enrolling Institution|
672724|NCT00346164|O2|Outcome|Histologic Grade 2 by Enrolling Institution|
672725|NCT00346164|O1|Outcome|Histologic Grade 1 by Enrolling Institution|
672726|NCT00346164|O1|Outcome|All Patients|All patients
672727|NCT00346164|O3|Outcome|Histologic Grade 3|
672728|NCT00346164|O2|Outcome|Histologic Grade 2|
672729|NCT00346164|O1|Outcome|Histologic Grade 1|
672730|NCT00346164|O2|Outcome|Metastatic|
672731|NCT00346164|O1|Outcome|Non-metastatic|
672732|NCT00346164|O3|Outcome|Positive Margins|
672733|NCT00346164|O2|Outcome|Negative Margins|
672734|NCT00346164|O1|Outcome|Less Than Total Resection|
672735|NCT00346164|O2|Outcome|Metastatic|
672736|NCT00346164|O1|Outcome|Non-metastatic|
672737|NCT00346164|O3|Outcome|Histologic Grade 3|
672738|NCT00346164|O2|Outcome|Histologic Grade 2|
672739|NCT00346164|O1|Outcome|Histologic Grade 1|
672740|NCT00346164|O2|Outcome|Metastatic|
672741|NCT00346164|O1|Outcome|Non-metastatic|
672742|NCT00346164|O1|Outcome|Arm D|Intermediate & High Risk; Neoadjuvant chemoradiotherapy
672743|NCT00346164|O1|Outcome|Arm D|Intermediate & High Risk; Neoadjuvant chemoradiotherapy
672744|NCT00346164|O1|Outcome|Arm D|Intermediate & High Risk; Neoadjuvant chemoradiotherapy
672745|NCT00346164|O4|Outcome|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672746|NCT00346164|O3|Outcome|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672797|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672747|NCT00346164|O2|Outcome|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
672748|NCT00346164|O1|Outcome|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
672749|NCT00346164|E4|Reported Event|Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672750|NCT00346164|E3|Reported Event|Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy|"High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.~doxorubicin hydrochloride: Given IV~clinical observation: Patients undergo observation~3-dimensional conformal radiation therapy: Patients undergo radiotherapy~ifosfamide: Given IV"
672751|NCT00346164|E2|Reported Event|Arm B: Low Risk; Adjuvant Radiotherapy|"Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery~3-dimensional conformal radiation therapy: Patients undergo radiotherapy"
672752|NCT00346164|E1|Reported Event|Arm A: No Adjuvant Treatment|"Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).~clinical observation: Patients undergo observation~therapeutic conventional surgery: Patients undergo surgery"
672753|NCT00346151|B1|Baseline|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672754|NCT00346151|P1|Participant Flow|Belatacept|Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
672755|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672756|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672757|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672758|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672759|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672760|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672761|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672762|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672763|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672764|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672765|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672766|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672767|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672768|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672769|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672770|NCT00346151|E1|Reported Event|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
672771|NCT00346034|B1|Baseline|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
672798|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
673234|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
672772|NCT00346034|P1|Participant Flow|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
672773|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
672774|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
672775|NCT00346034|E1|Reported Event|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
672776|NCT00345969|B3|Baseline|Total|Total of all reporting groups
672777|NCT00345969|B2|Baseline|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672778|NCT00345969|B1|Baseline|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672779|NCT00345969|P2|Participant Flow|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672780|NCT00345969|P1|Participant Flow|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672781|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672782|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672783|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672784|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672785|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672786|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672787|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672788|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672789|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672790|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672791|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672792|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672793|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672794|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672795|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672796|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672839|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672799|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672800|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672801|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672802|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672803|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672804|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672805|NCT00345969|O2|Outcome|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672806|NCT00345969|O1|Outcome|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672807|NCT00345969|E2|Reported Event|Exercise + Testosterone|Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
672808|NCT00345969|E1|Reported Event|Exercise + Placebo|Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
672809|NCT00345878|B3|Baseline|Total|Total of all reporting groups
672810|NCT00345878|B2|Baseline|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672811|NCT00345878|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672812|NCT00345878|P2|Participant Flow|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672813|NCT00345878|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672814|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672815|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672816|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672817|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672818|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672819|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672820|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672821|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672822|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672823|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672824|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672825|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672826|NCT00345878|E2|Reported Event|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
672827|NCT00345878|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
672828|NCT00345839|B3|Baseline|Total|Total of all reporting groups
672829|NCT00345839|B2|Baseline|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672830|NCT00345839|B1|Baseline|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672831|NCT00345839|P2|Participant Flow|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672832|NCT00345839|P1|Participant Flow|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672833|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672834|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672835|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672836|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672837|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672838|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672840|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672841|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672842|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672843|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672844|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672845|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672846|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672847|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672848|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672849|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672850|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672851|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
672852|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672853|NCT00345839|E2|Reported Event|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
672854|NCT00345839|E1|Reported Event|Placebo|
672855|NCT00345683|B3|Baseline|Total|Total of all reporting groups
672856|NCT00345683|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672857|NCT00345683|B1|Baseline|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672858|NCT00345683|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672859|NCT00345683|P1|Participant Flow|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672860|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672861|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672862|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672863|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672879|NCT00345631|B3|Baseline|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672864|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672865|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672866|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672867|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672868|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672869|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672870|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672871|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672872|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672873|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672874|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672875|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672876|NCT00345683|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672877|NCT00345683|E1|Reported Event|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672878|NCT00345631|B4|Baseline|Total|Total of all reporting groups
673235|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
672882|NCT00345631|P3|Participant Flow|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672883|NCT00345631|P2|Participant Flow|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672884|NCT00345631|P1|Participant Flow|Roll-In|Roll-In patients were device training patients
672885|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672886|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672887|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672888|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672889|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672890|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672891|NCT00345631|O3|Outcome|Manual Compression (Not Applicable for Device Success)|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672892|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672893|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672894|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672895|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672896|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672897|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672898|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672899|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672900|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672901|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672902|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672903|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672904|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672905|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672906|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672907|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672908|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
672909|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672910|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672911|NCT00345631|O1|Outcome|Roll-In|patients were device training patients
672912|NCT00345631|E3|Reported Event|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
672913|NCT00345631|E2|Reported Event|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
672914|NCT00345631|E1|Reported Event|Roll-In|Roll-In patients were device training patients
672915|NCT00345605|B1|Baseline|High-dose Arginine vs Low-dose Arginine Plus Buphenyl|
672916|NCT00345605|P2|Participant Flow|Low Dose First|low dose arm 3 day wash-out followed by 7 days of: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA interval then: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA
672917|NCT00345605|P1|Participant Flow|High Dose First|High dose arm 3 day wash-out followed by 7 days of: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA interval then: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA
673236|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
672918|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
672919|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
672920|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
672921|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
672922|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
672923|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
672924|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
672925|NCT00345605|O1|Outcome|High-dose Arginine Alone|
672926|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
672927|NCT00345605|O1|Outcome|High-dose Arginine Alone|
672928|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
672929|NCT00345605|O1|Outcome|High-dose Arginine Alone|
672930|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
672931|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
672932|NCT00345605|E2|Reported Event|Low-dose Arginine Plus Buphenyl|
672933|NCT00345605|E1|Reported Event|High-dose Arginine Alone|
672934|NCT00345592|B3|Baseline|Total|Total of all reporting groups
672935|NCT00345592|B2|Baseline|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
672936|NCT00345592|B1|Baseline|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
672937|NCT00345592|P2|Participant Flow|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
672938|NCT00345592|P1|Participant Flow|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
672939|NCT00345592|O2|Outcome|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
672940|NCT00345592|O1|Outcome|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
672941|NCT00345592|E2|Reported Event|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
672942|NCT00345592|E1|Reported Event|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
672943|NCT00345579|B3|Baseline|Total|Total of all reporting groups
672989|NCT00345371|B2|Baseline|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
672990|NCT00345371|B1|Baseline|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
672944|NCT00345579|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672945|NCT00345579|B1|Baseline|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672946|NCT00345579|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672947|NCT00345579|P1|Participant Flow|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672948|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672949|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672950|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672951|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672952|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672953|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672954|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672955|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672956|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672957|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672958|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
673237|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
672959|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672960|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672961|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672962|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672963|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672964|NCT00345579|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672965|NCT00345579|E1|Reported Event|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
672966|NCT00345540|B1|Baseline|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
672967|NCT00345540|P1|Participant Flow|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
672968|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
672969|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
672970|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
672971|NCT00345540|E1|Reported Event|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
672972|NCT00345397|B1|Baseline|Subjects Receiving Percutaneous Endoscopic Colostomy (PEC)|Quality of Life (QOL) evaluation before and after device placement
672973|NCT00345397|P1|Participant Flow|Subjects Receiving PEC Tube|All Enrolled Subjects receiving PEC Placement
672974|NCT00345397|O2|Outcome|SCI-Specific QoL Evaluation in Subjects Receiving PEC Tube|SCI-Specific QoL evaluation before and after device placement
672975|NCT00345397|O1|Outcome|Global SCI-QoL Score in Subjects Receiving PEC Tube|Global SCI-QoL Score before and after device placement
672976|NCT00345397|E1|Reported Event|Subjects Receiving PEC Tube|QoL evaluation before and after device placement
672977|NCT00345384|B3|Baseline|Total|Total of all reporting groups
672978|NCT00345384|B2|Baseline|Dexmedetomidine|titrated IV for 24 hours post ICU
672979|NCT00345384|B1|Baseline|Normal Saline|Standard of care
672980|NCT00345384|P2|Participant Flow|Dexmedetomidine|Received Dexmedetomidine for 24 hours
672981|NCT00345384|P1|Participant Flow|Normal Saline|Blinded Normal saline infusion titrated as if study drug
672982|NCT00345384|O2|Outcome|Dexmedetomidine|"Study group to receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 30 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU~Dexmedetomidine: Dexmedetomidine titrated over 24 hours"
672983|NCT00345384|O1|Outcome|Placebo|Control group to receive a normal saline infusion, set at a rate as if it were the active drug.
672984|NCT00345384|O2|Outcome|Dexmedetomidine|Patient group to receive Dexmedetomidine.
672985|NCT00345384|O1|Outcome|Placebo|Patient group to receive placebo (saline).
672986|NCT00345384|E2|Reported Event|Study Drug Group|Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU
672987|NCT00345384|E1|Reported Event|Normal Saline Group|Normal saline infused at calculated rate as if it were study drug
672988|NCT00345371|B3|Baseline|Total|Total of all reporting groups
673060|NCT00345046|P1|Participant Flow|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
672991|NCT00345371|P2|Participant Flow|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
672992|NCT00345371|P1|Participant Flow|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
672993|NCT00345371|O2|Outcome|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
672994|NCT00345371|O1|Outcome|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
672995|NCT00345371|O2|Outcome|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
672996|NCT00345371|O1|Outcome|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
672997|NCT00345371|E2|Reported Event|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
672998|NCT00345371|E1|Reported Event|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
672999|NCT00345332|B3|Baseline|Total|Total of all reporting groups
673000|NCT00345332|B2|Baseline|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
673001|NCT00345332|B1|Baseline|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
673002|NCT00345332|P2|Participant Flow|Botox Group|Botox (BTX) was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
673003|NCT00345332|P1|Participant Flow|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
673004|NCT00345332|O2|Outcome|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
673005|NCT00345332|O1|Outcome|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
673006|NCT00345332|O2|Outcome|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
673007|NCT00345332|O1|Outcome|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
673008|NCT00345332|E2|Reported Event|Botox Group|BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
673009|NCT00345332|E1|Reported Event|Placebo Group|6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
673010|NCT00345293|B1|Baseline|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
673011|NCT00345293|P2|Participant Flow|DC/PC3- Adherent|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using the adherence method.
673012|NCT00345293|P1|Participant Flow|DC/PC3 Vaccine-selected|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using antibodies.
673013|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
673014|NCT00345293|O2|Outcome|DC/PC3- Adherent|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from the adherent subset of peripheral blood mononuclear cells."
673015|NCT00345293|O1|Outcome|DC/PC3 Vaccine- Selected|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from antibody selected cells."
673124|NCT00344500|B2|Baseline|Lifestyle Balance|Weight management education and counseling
673016|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
673017|NCT00345293|E1|Reported Event|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
673018|NCT00345254|B3|Baseline|Total|Total of all reporting groups
673019|NCT00345254|B2|Baseline|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
673020|NCT00345254|B1|Baseline|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
673021|NCT00345254|P2|Participant Flow|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
673022|NCT00345254|P1|Participant Flow|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
673023|NCT00345254|O2|Outcome|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
673024|NCT00345254|O1|Outcome|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
673025|NCT00345254|E2|Reported Event|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
673026|NCT00345254|E1|Reported Event|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
673027|NCT00345176|B5|Baseline|Total|Total of all reporting groups
673028|NCT00345176|B4|Baseline|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
673029|NCT00345176|B3|Baseline|DHA/EPA|DHA (350 mg)/EPA (650 mg)
673030|NCT00345176|B2|Baseline|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
673031|NCT00345176|B1|Baseline|Placebo/Control|Considered control because all participants received the AREDS formulation
673032|NCT00345176|P4|Participant Flow|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
673033|NCT00345176|P3|Participant Flow|DHA/EPA|DHA (350 mg)/EPA (650 mg)
673034|NCT00345176|P2|Participant Flow|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
673035|NCT00345176|P1|Participant Flow|Placebo/Control|Considered control because all participants received the AREDS formulation
673036|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|Lutein main effect - includes all participants who received Lutein/Zeaxanthin
673037|NCT00345176|O1|Outcome|No Lutein/Zeaxanthin|Lutein main effect - includes participants who did not receive Lutein/Zeaxanthin
673038|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
673039|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
673040|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
673041|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
673042|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
673043|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
673044|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
673045|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
673046|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
673047|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
673048|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
673049|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
673050|NCT00345176|E4|Reported Event|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
673051|NCT00345176|E3|Reported Event|DHA/EPA|DHA (350 mg)/EPA (650 mg)
673052|NCT00345176|E2|Reported Event|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
673053|NCT00345176|E1|Reported Event|Placebo/Control|Considered control because all participants received the AREDS formulation
673054|NCT00345046|B4|Baseline|Total|Total of all reporting groups
673055|NCT00345046|B3|Baseline|Prednisolone Acetate|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
673056|NCT00345046|B2|Baseline|EconoPred Plus|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
673057|NCT00345046|B1|Baseline|Pred Forte|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
673058|NCT00345046|P3|Participant Flow|Prednisolone Acetate 1%|Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
673059|NCT00345046|P2|Participant Flow|EconPred Plus 1%|EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
673061|NCT00345046|O3|Outcome|Predisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
673062|NCT00345046|O2|Outcome|Econo Pred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
673063|NCT00345046|O1|Outcome|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
673064|NCT00345046|E3|Reported Event|Prednisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
673065|NCT00345046|E2|Reported Event|EconoPred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
673066|NCT00345046|E1|Reported Event|Pred Forte 1%|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
673067|NCT00345033|B3|Baseline|Total|Total of all reporting groups
673068|NCT00345033|B2|Baseline|Placebo|Participants will take placebo for 8 weeks.
673069|NCT00345033|B1|Baseline|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673070|NCT00345033|P2|Participant Flow|Placebo|Participants will take placebo for 8 weeks.
673071|NCT00345033|P1|Participant Flow|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673072|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
673073|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673074|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
673075|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673076|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
673077|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673078|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
673079|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673080|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
673081|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673082|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
673083|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673084|NCT00345033|E2|Reported Event|Placebo|Participants will take placebo for 8 weeks.
673085|NCT00345033|E1|Reported Event|Aripiprazole|Participants will take aripiprazole for 8 weeks.
673086|NCT00344968|B4|Baseline|Total|Total of all reporting groups
673087|NCT00344968|B3|Baseline|0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
673088|NCT00344968|B2|Baseline|0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
673089|NCT00344968|B1|Baseline|Sham Comparator|Procedure: Standard of care laser photocoagulation
673090|NCT00344968|P3|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
673091|NCT00344968|P2|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
673092|NCT00344968|P1|Participant Flow|Sham Comparator|Procedure: Standard of care laser photocoagulation
673093|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
673094|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
673095|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
673096|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
673097|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
673098|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
673099|NCT00344968|E3|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
673100|NCT00344968|E2|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
673101|NCT00344968|E1|Reported Event|Sham Comparator|Standard of care laser photocoagulation
673102|NCT00344773|B1|Baseline|Gefitinib|Gefitinib 250mg tablet
673103|NCT00344773|P1|Participant Flow|Gefitinib|Gefitinib 250mg tablet
673104|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
673105|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
673106|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
673107|NCT00344773|E1|Reported Event|Gefitinib|Gefitinib 250mg tablet
673108|NCT00344682|B3|Baseline|Total|Total of all reporting groups
673109|NCT00344682|B2|Baseline|Memantine|memantine : memantine 5mg - 20mg PO daily
673110|NCT00344682|B1|Baseline|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
673111|NCT00344682|P2|Participant Flow|Memantine|memantine : memantine 5mg - 20mg PO daily
673112|NCT00344682|P1|Participant Flow|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
673113|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
673114|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
673115|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
673116|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
673117|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
673118|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
673119|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
673120|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
673121|NCT00344682|E2|Reported Event|Memantine|memantine : memantine 5mg - 20mg PO daily
673122|NCT00344682|E1|Reported Event|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
673123|NCT00344500|B3|Baseline|Total|Total of all reporting groups
673125|NCT00344500|B1|Baseline|Usual Care|Usual Care control group
673126|NCT00344500|P3|Participant Flow|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
673127|NCT00344500|P2|Participant Flow|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
673128|NCT00344500|P1|Participant Flow|Usual Care|Usual Care control group
673129|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
673130|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
673131|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
673132|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
673133|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
673134|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
673135|NCT00344500|E3|Reported Event|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
673136|NCT00344500|E2|Reported Event|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
673137|NCT00344500|E1|Reported Event|Usual Care|Usual Care control group
673138|NCT00344487|B1|Baseline|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks
673139|NCT00344487|P1|Participant Flow|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
673140|NCT00344487|O1|Outcome|Kaletra|lopinavir/ritonavir 400/100mg tablets by mouth twice a day for 48 weeks
673141|NCT00344487|E1|Reported Event|Kaletra|lopinavir/ritonavir 400/100mg tablets by mouth twice a day for 48 weeks
673142|NCT00344461|B1|Baseline|TDF, FTC & NVP|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
673143|NCT00344461|P1|Participant Flow|Single Group (TDF/FTC & NVP)|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
673144|NCT00344461|O1|Outcome|Nevirapine, FTC, Tenofovir|"Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.~Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d."
673145|NCT00344461|O1|Outcome|Nevirapine, FTC, Tenofovir|"Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.~Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d."
673146|NCT00344461|O1|Outcome|Nevirapine, FTC, Tenofovir|"Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.~Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d."
673147|NCT00344461|O1|Outcome|Single Group (TDF/FTC & NVP)|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
673148|NCT00344461|O1|Outcome|Nevirapine, FTC, Tenofovir|"Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks.~Nevirapine, FTC, and Tenofovir: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d."
673149|NCT00344461|O1|Outcome|Single Group (TDF/FTC & NVP)|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
673150|NCT00344461|E1|Reported Event|FTC, TDF, & NVP|To evaluate the long-term antiviral activity of a three cell cycle independent reverse transcriptase regimen consisting of Nevirapine 200mg twice-a-day, Tenofovir 300mg and Emtricitabine 200mg once-a-day in the treatment of patients with chronic HIV infection.
673151|NCT00344448|B3|Baseline|Total|Total of all reporting groups
673152|NCT00344448|B2|Baseline|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
673153|NCT00344448|B1|Baseline|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
673154|NCT00344448|P2|Participant Flow|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
673155|NCT00344448|P1|Participant Flow|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
673156|NCT00344448|O2|Outcome|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
673228|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
673229|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
673157|NCT00344448|O1|Outcome|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
673158|NCT00344448|E2|Reported Event|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
673159|NCT00344448|E1|Reported Event|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
673160|NCT00344370|B3|Baseline|Total|Total of all reporting groups
673161|NCT00344370|B2|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
673162|NCT00344370|B1|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
673163|NCT00344370|P2|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
673164|NCT00344370|P1|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
673165|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
673166|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
673167|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
673168|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
673169|NCT00344370|E2|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
673170|NCT00344370|E1|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
673171|NCT00344305|B3|Baseline|Total|Total of all reporting groups
673172|NCT00344305|B2|Baseline|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673173|NCT00344305|B1|Baseline|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673174|NCT00344305|P2|Participant Flow|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673175|NCT00344305|P1|Participant Flow|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673176|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673177|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673178|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673179|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673180|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673181|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673182|NCT00344305|O1|Outcome|All Participants|Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673582|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
673183|NCT00344305|O1|Outcome|All Participants|Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673184|NCT00344305|O1|Outcome|All Participants|Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673185|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673186|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673187|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673188|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673189|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673190|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673191|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673192|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673193|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673194|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673195|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673196|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673197|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673230|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
673231|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
673583|NCT00342628|E3|Reported Event|DTP Vaccines|DTP at 2, 4, and 6 months of age
673198|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673199|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673200|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673201|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673202|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673203|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673204|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673205|NCT00344305|O2|Outcome|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673206|NCT00344305|O1|Outcome|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673207|NCT00344305|E2|Reported Event|Cohort 2: Participants Between 24 to < 60 Months Age|Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673208|NCT00344305|E1|Reported Event|Cohort 1: Participants Between 6 to < 24 Months Age|Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
673209|NCT00344175|B3|Baseline|Total|Total of all reporting groups
673210|NCT00344175|B2|Baseline|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
673211|NCT00344175|B1|Baseline|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
673212|NCT00344175|P2|Participant Flow|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
673213|NCT00344175|P1|Participant Flow|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
673214|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
673215|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
673216|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
673217|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
673218|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
673219|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
673220|NCT00344175|E2|Reported Event|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
673221|NCT00344175|E1|Reported Event|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
673222|NCT00344032|B3|Baseline|Total|Total of all reporting groups
673223|NCT00344032|B2|Baseline|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
673224|NCT00344032|B1|Baseline|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
673225|NCT00344032|P2|Participant Flow|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
673226|NCT00344032|P1|Participant Flow|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
673227|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
673238|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
673239|NCT00344032|E2|Reported Event|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
673240|NCT00344032|E1|Reported Event|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
673241|NCT00344019|B4|Baseline|Total|Total of all reporting groups
673242|NCT00344019|B3|Baseline|Screening|# patients who signed consent form prior to angiography. 74 did not continue, 23 completed the study. It is believed that most of the 74 did not continue due to the fact that no PCI was indicated at time of angiography
673243|NCT00344019|B2|Baseline|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
673244|NCT00344019|B1|Baseline|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
673245|NCT00344019|P3|Participant Flow|Screening|Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
673246|NCT00344019|P2|Participant Flow|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
673247|NCT00344019|P1|Participant Flow|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
673248|NCT00344019|O3|Outcome|Screening|Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
673249|NCT00344019|O2|Outcome|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
673250|NCT00344019|O1|Outcome|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
673251|NCT00344019|O3|Outcome|Screening|Patients that signed consent to participate. Of 97 patients that consented, only 23 completed the study. 74 patients did not continue likely due to no PCI indicated at time of angiogram. Individual subject data no longer available.
673252|NCT00344019|O2|Outcome|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
673253|NCT00344019|O1|Outcome|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
673254|NCT00344019|O3|Outcome|Screening|Patients signed consent if willing to participate. Patients will continue onto randomization if appropriate per inc/exc (i.e. stent placement) otherwise screen fail
673255|NCT00344019|O2|Outcome|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS~Screening: Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)"
673256|NCT00344019|O1|Outcome|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI~Screening: Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)"
673257|NCT00344019|O2|Outcome|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
673258|NCT00344019|O1|Outcome|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
673259|NCT00344019|E3|Reported Event|Screening|97 patients screened 23 patients completed study in 1:1 randomization scheme. Randomization assignment not known. Data no longer available. No data analyzed
673260|NCT00344019|E2|Reported Event|Placebo Oral Tablet|"placebo on average of 2-4 hours pre angio/PCI for ACS~Placebo Oral Tablet: placebo pre-PCI for ACS"
673261|NCT00344019|E1|Reported Event|Atorvastatin 80 mg|"80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS~Atorvastatin 80mg: atorvastatin 80 mg pre-angio/PCI"
673262|NCT00343915|B3|Baseline|Total|Total of all reporting groups
673263|NCT00343915|B2|Baseline|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673264|NCT00343915|B1|Baseline|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673265|NCT00343915|P2|Participant Flow|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673266|NCT00343915|P1|Participant Flow|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673267|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673268|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673269|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673270|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673271|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
673272|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673273|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673274|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673275|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673384|NCT00343460|B4|Baseline|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673276|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673277|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673278|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673279|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673280|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673281|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
673282|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673283|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673284|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673285|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673286|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673287|NCT00343915|E2|Reported Event|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
673288|NCT00343915|E1|Reported Event|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
673289|NCT00343889|B3|Baseline|Total|Total of all reporting groups
673290|NCT00343889|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673291|NCT00343889|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673292|NCT00343889|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673293|NCT00343889|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673294|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673295|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673296|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673297|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673298|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673299|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673300|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673301|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673302|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673303|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673304|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673305|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673306|NCT00343889|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
673307|NCT00343889|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
673308|NCT00343863|B3|Baseline|Total|Total of all reporting groups
673309|NCT00343863|B2|Baseline|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673310|NCT00343863|B1|Baseline|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673311|NCT00343863|P2|Participant Flow|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673312|NCT00343863|P1|Participant Flow|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673313|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
673314|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
673315|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673316|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673317|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673318|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673319|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673320|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673321|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673322|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673323|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673324|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673325|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673326|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673327|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673328|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673329|NCT00343863|O2|Outcome|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673330|NCT00343863|O1|Outcome|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673331|NCT00343863|E2|Reported Event|Dexamethasone + Palonosetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673332|NCT00343863|E1|Reported Event|Dexamethasone + Ondansetron IV|"All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.~Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)."
673333|NCT00343785|B1|Baseline|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
673334|NCT00343785|P1|Participant Flow|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
673335|NCT00343785|O1|Outcome|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
673336|NCT00343785|O1|Outcome|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
673337|NCT00343785|O1|Outcome|Patients Receive a Conditioning Regimen Comprising Cyclophosph|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
673338|NCT00343785|E1|Reported Event|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
673339|NCT00343564|B12|Baseline|Total|Total of all reporting groups
673340|NCT00343564|B11|Baseline|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
673341|NCT00343564|B10|Baseline|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
673342|NCT00343564|B9|Baseline|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
673343|NCT00343564|B8|Baseline|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
673344|NCT00343564|B7|Baseline|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
673345|NCT00343564|B6|Baseline|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
673346|NCT00343564|B5|Baseline|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
673347|NCT00343564|B4|Baseline|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
673348|NCT00343564|B3|Baseline|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
673349|NCT00343564|B2|Baseline|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
673350|NCT00343564|B1|Baseline|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
673351|NCT00343564|P11|Participant Flow|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
673352|NCT00343564|P10|Participant Flow|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
673353|NCT00343564|P9|Participant Flow|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
673354|NCT00343564|P8|Participant Flow|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
673355|NCT00343564|P7|Participant Flow|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
673356|NCT00343564|P6|Participant Flow|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
673357|NCT00343564|P5|Participant Flow|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
673358|NCT00343564|P4|Participant Flow|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
673359|NCT00343564|P3|Participant Flow|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
673360|NCT00343564|P2|Participant Flow|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
673361|NCT00343564|P1|Participant Flow|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
673362|NCT00343564|O2|Outcome|Dose Escalation Cohorts 7-11 (w/ GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support (cohorts 7,8,9,10 and 11)
673363|NCT00343564|O1|Outcome|Dose Escalation Cohorts 1-6 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support (cohorts 1,2,3,4,5 and 6).
673364|NCT00343564|E11|Reported Event|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
673365|NCT00343564|E10|Reported Event|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
673366|NCT00343564|E9|Reported Event|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
673367|NCT00343564|E8|Reported Event|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
673368|NCT00343564|E7|Reported Event|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
673369|NCT00343564|E6|Reported Event|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
673370|NCT00343564|E5|Reported Event|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
673371|NCT00343564|E4|Reported Event|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
673372|NCT00343564|E3|Reported Event|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
673373|NCT00343564|E2|Reported Event|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
673374|NCT00343564|E1|Reported Event|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
673375|NCT00343512|B1|Baseline|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
673376|NCT00343512|P1|Participant Flow|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
673377|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
673378|NCT00343512|O1|Outcome|Therapeutic Intervention|
673379|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
673380|NCT00343512|E1|Reported Event|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
673381|NCT00343460|B7|Baseline|Total|Total of all reporting groups
673382|NCT00343460|B6|Baseline|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673383|NCT00343460|B5|Baseline|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673385|NCT00343460|B3|Baseline|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673386|NCT00343460|B2|Baseline|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673387|NCT00343460|B1|Baseline|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673388|NCT00343460|P3|Participant Flow|Aloxi 0.25 mg|Aloxi 0.25 mg - Safety Population
673389|NCT00343460|P2|Participant Flow|APF530 10 mg|APF530 10 mg - Safety Population
673390|NCT00343460|P1|Participant Flow|APF530 5 mg|APF530 5 mg - Safety Population
673391|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673392|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673393|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673394|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673395|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673396|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673397|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673398|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673399|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673400|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673401|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673402|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673403|NCT00343460|O4|Outcome|Cycles 1, 2, 3, and 4 - Highly|APF530 10 mg
673404|NCT00343460|O3|Outcome|Cycles 1, 2, 3 and 4 - Highly|APF530 5 mg
673405|NCT00343460|O2|Outcome|Cycles 1, 2, 3, and 4 - Moderately|APF530 10 mg
673406|NCT00343460|O1|Outcome|Cycles 1, 2, 3 and 4 - Moderately|APF530 5 mg
673407|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673408|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673409|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673410|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673411|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673412|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673413|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673414|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673415|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673416|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673417|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673418|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673419|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673420|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673421|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673422|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673423|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673424|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673425|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673426|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673427|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673428|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673429|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673430|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673431|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673432|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673433|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673434|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673435|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673436|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673437|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673438|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673439|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673440|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673441|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673442|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673443|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673444|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673445|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673446|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673447|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673448|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673449|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673450|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673451|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
673452|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673453|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673454|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
673455|NCT00343460|E5|Reported Event|Cycle 2-4 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
673456|NCT00343460|E4|Reported Event|Cycles 2-4 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
673457|NCT00343460|E3|Reported Event|Cycle 1 Aloxi 0.25 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
673458|NCT00343460|E2|Reported Event|Cycle 1 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
673459|NCT00343460|E1|Reported Event|Cycle 1 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
673460|NCT00343382|B4|Baseline|Total|Total of all reporting groups
673461|NCT00343382|B3|Baseline|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
673462|NCT00343382|B2|Baseline|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
673463|NCT00343382|B1|Baseline|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
673464|NCT00343382|P3|Participant Flow|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
673465|NCT00343382|P2|Participant Flow|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
673466|NCT00343382|P1|Participant Flow|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
673467|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
673468|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
673469|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
673470|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
673471|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
673472|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
673473|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
673474|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
673475|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
673476|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
673477|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
673478|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
673479|NCT00343382|E3|Reported Event|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
673480|NCT00343382|E2|Reported Event|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
673481|NCT00343382|E1|Reported Event|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
673482|NCT00343291|B3|Baseline|Total|Total of all reporting groups
673533|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673534|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673535|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673483|NCT00343291|B2|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673484|NCT00343291|B1|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673485|NCT00343291|P2|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673486|NCT00343291|P1|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673487|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673488|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673489|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673490|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673491|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673492|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673493|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673494|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673536|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673537|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673538|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
674979|NCT00335257|B1|Baseline|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen )
673495|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673496|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673497|NCT00343291|E2|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673498|NCT00343291|E1|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
673499|NCT00343252|B3|Baseline|Total|Total of all reporting groups
673500|NCT00343252|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673501|NCT00343252|B1|Baseline|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673502|NCT00343252|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673503|NCT00343252|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673504|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673505|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673506|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673507|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673508|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673509|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673510|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673511|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673512|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673513|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673514|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673515|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673516|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673517|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673518|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673519|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673520|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673521|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673522|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673523|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673524|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673525|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673526|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673527|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673528|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673529|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673530|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673531|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673532|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673539|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673540|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673541|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673542|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673543|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673544|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673545|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673546|NCT00343252|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
673547|NCT00343252|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
673548|NCT00343083|B1|Baseline|Cetuximab (ERBITUX) and Concurrent Carboplatin|
673549|NCT00343083|P1|Participant Flow|Cetuximab (ERBITUX) and Concurrent Carboplatin|". Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week.~The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV."
673550|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
673551|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
673552|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
673553|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
673554|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
673555|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
673556|NCT00343083|E1|Reported Event|Cetuximab (ERBITUX) and Concurrent Carboplatin|
673557|NCT00343044|B1|Baseline|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
673558|NCT00343044|P1|Participant Flow|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
673559|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
673560|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
673561|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
673562|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
673563|NCT00343044|E1|Reported Event|Arm 1|Patients (N=40)
673564|NCT00342628|B4|Baseline|Total|Total of all reporting groups
673565|NCT00342628|B3|Baseline|DTP Vaccines|DTP at 2, 4, and 6 months of age
673566|NCT00342628|B2|Baseline|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
673567|NCT00342628|B1|Baseline|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
673568|NCT00342628|P3|Participant Flow|DTP Vaccines|DTP at 2, 4, and 6 months of age
673569|NCT00342628|P2|Participant Flow|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
673570|NCT00342628|P1|Participant Flow|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
673571|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
673572|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
673573|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
673574|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
673575|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
673576|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
673577|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
673578|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
673579|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
673580|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
673584|NCT00342628|E2|Reported Event|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
673585|NCT00342628|E1|Reported Event|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
673586|NCT00342563|B5|Baseline|Total|Total of all reporting groups
673587|NCT00342563|B4|Baseline|Placebo- Non-Smoker|
673588|NCT00342563|B3|Baseline|Placebo-Smoker|Placebo: Placebo
673589|NCT00342563|B2|Baseline|Mecamylamine-Non-Smoker|
673590|NCT00342563|B1|Baseline|Mecamylamine-Smoker|mecamylamine: mecamylamine 10mg/day
673591|NCT00342563|P4|Participant Flow|Placebo Non-Smoker|
673592|NCT00342563|P3|Participant Flow|Placebo Smoker|
673593|NCT00342563|P2|Participant Flow|Mecamylamine Non-Smoker|
673594|NCT00342563|P1|Participant Flow|Mecamylamine- Smoker|mecamylamine: mecamylamine 10mg/day
673595|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
673596|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
673597|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
673598|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
673599|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
673600|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
673601|NCT00342563|O4|Outcome|Placebo- Non-Smoker|
673602|NCT00342563|O3|Outcome|Placebo-Smoker|Placebo
673603|NCT00342563|O2|Outcome|Mecamylamine- Non-Smoker|mecamylamine: mecamylamine 10mg/day
673604|NCT00342563|O1|Outcome|Mecamylamine- Smokers|mecamylamine: mecamylamine 10mg/day
673605|NCT00342563|E4|Reported Event|Placebo Non-Smoker|Placebo: Placebo
673606|NCT00342563|E3|Reported Event|Placebo Smoker|Placebo: Placebo
673607|NCT00342563|E2|Reported Event|Mecamylamine Non-Smoker|mecamylamine: mecamylamine 10mg/day
673608|NCT00342563|E1|Reported Event|Mecamylamine Smoker|mecamylamine: mecamylamine 10mg/day
673609|NCT00342355|B5|Baseline|Total|Total of all reporting groups
673610|NCT00342355|B4|Baseline|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
673611|NCT00342355|B3|Baseline|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
673612|NCT00342355|B2|Baseline|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
673613|NCT00342355|B1|Baseline|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
673614|NCT00342355|P4|Participant Flow|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
673615|NCT00342355|P3|Participant Flow|d4T + 3TC + EFV|Stavudine + Lamivudine + Efavirenz
673616|NCT00342355|P2|Participant Flow|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
673617|NCT00342355|P1|Participant Flow|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
673618|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
673619|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
673620|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
673621|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
673622|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
673623|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
673624|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
673625|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
673626|NCT00342355|E4|Reported Event|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
673627|NCT00342355|E3|Reported Event|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
673628|NCT00342355|E2|Reported Event|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
673629|NCT00342355|E1|Reported Event|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
673630|NCT00340834|B6|Baseline|Total|Total of all reporting groups
673631|NCT00340834|B5|Baseline|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
673632|NCT00340834|B4|Baseline|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
673633|NCT00340834|B3|Baseline|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
673634|NCT00340834|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673635|NCT00340834|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673636|NCT00340834|P5|Participant Flow|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
673637|NCT00340834|P4|Participant Flow|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
673638|NCT00340834|P3|Participant Flow|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
673639|NCT00340834|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673640|NCT00340834|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673805|NCT00340379|P2|Participant Flow|Sertraline/Haloperidol|Target dosage of 150-200mg/day for sertraline and 6-8mg/day for haloperidol.
673641|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
673642|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673643|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673644|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
673645|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673646|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673647|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
673648|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673649|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673650|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
673651|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673652|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673653|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
673654|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673655|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673656|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
673657|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673658|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
673659|NCT00340834|E5|Reported Event|EXT FTY720 0.5 mg|EXT FTY720 0.5 mg
673660|NCT00340834|E4|Reported Event|EXT FTY720 1.25 mg|EXT FTY720 1.25 mg
673661|NCT00340834|E3|Reported Event|COR Interferon Beta-1a|COR Interferon beta-1a
673662|NCT00340834|E2|Reported Event|COR FTY720 0.5 mg|COR FTY720 0.5 mg
673663|NCT00340834|E1|Reported Event|COR FTY720 1.25 mg|COR FTY720 1.25 mg
673664|NCT00340704|B10|Baseline|Total|Total of all reporting groups
673665|NCT00340704|B9|Baseline|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673666|NCT00340704|B8|Baseline|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673806|NCT00340379|P1|Participant Flow|Ziprasidone|Target dosage of 120-160mg/day based on tolerance.
673807|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
673667|NCT00340704|B7|Baseline|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673668|NCT00340704|B6|Baseline|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673669|NCT00340704|B5|Baseline|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673670|NCT00340704|B4|Baseline|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673671|NCT00340704|B3|Baseline|Tamsulosin - High Dose Level (PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673672|NCT00340704|B2|Baseline|Tamsulosin - Medium Dose Level (PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673673|NCT00340704|B1|Baseline|Tamsulosin - Low Dose Level (PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673674|NCT00340704|P9|Participant Flow|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673808|NCT00340379|O1|Outcome|Ziprasidone|
673809|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
673810|NCT00340379|O1|Outcome|Ziprasidone|
673811|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
673812|NCT00340379|O1|Outcome|Ziprasidone|
673675|NCT00340704|P8|Participant Flow|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673676|NCT00340704|P7|Participant Flow|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673677|NCT00340704|P6|Participant Flow|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673678|NCT00340704|P5|Participant Flow|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673679|NCT00340704|P4|Participant Flow|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673680|NCT00340704|P3|Participant Flow|Tamsulosin - High Dose Level (PK Study)|"Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.~In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673681|NCT00340704|P2|Participant Flow|Tamsulosin - Medium Dose Level (PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673682|NCT00340704|P1|Participant Flow|Tamsulosin - Low Dose Level (PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673813|NCT00340379|E2|Reported Event|Sertraline/Haloperidol|
673814|NCT00340379|E1|Reported Event|Ziprasidone|
673815|NCT00339833|B3|Baseline|Total|Total of all reporting groups
673683|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673684|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673685|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673686|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673687|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673688|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673689|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673690|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673691|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673692|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673693|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673694|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673695|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673696|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673697|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673698|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673816|NCT00339833|B2|Baseline|Placebo|Identical placebo for 7 days
673817|NCT00339833|B1|Baseline|Salsalate|Salsalate (3g/day) for 7 days
673699|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673700|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673701|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673702|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673703|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673704|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673705|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673706|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673707|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673708|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673709|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673710|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673711|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673712|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673713|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673714|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673715|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673716|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673717|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
673718|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673719|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673720|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
673721|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
673722|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
673818|NCT00339833|P2|Participant Flow|Placebo|Placebo for 7 days.
673819|NCT00339833|P1|Participant Flow|Salsalate|The intervention was salsalate (3g/day) for 7 days
673820|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
673821|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
673822|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
673823|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
673824|NCT00339833|E2|Reported Event|Placebo|Identical placebo for 7 days
673825|NCT00339833|E1|Reported Event|Salsalate|Salsalate (3g/day) for 7 days
673826|NCT00339183|B3|Baseline|Total|Total of all reporting groups
673723|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673724|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673725|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673726|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673727|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673728|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673729|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673730|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673731|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673732|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673733|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673734|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673735|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673736|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673737|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673738|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
674980|NCT00335257|P3|Participant Flow|OCs Non-DRSP|Users of OCs containing other progestins
673739|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673740|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673741|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673742|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673743|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673744|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673745|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673746|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673747|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673748|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673749|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673750|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673751|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673752|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673753|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673754|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673755|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673756|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673757|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673758|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673759|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673760|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673761|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673762|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673763|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673764|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673765|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673766|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673767|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673768|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673769|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673770|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673771|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673772|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
673773|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
673774|NCT00340704|E9|Reported Event|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673775|NCT00340704|E8|Reported Event|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673776|NCT00340704|E7|Reported Event|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673777|NCT00340704|E6|Reported Event|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673778|NCT00340704|E5|Reported Event|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673779|NCT00340704|E4|Reported Event|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673780|NCT00340704|E3|Reported Event|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673781|NCT00340704|E2|Reported Event|Tamsulosin - Medium Dose Level (Steady State - PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
673782|NCT00340704|E1|Reported Event|Tamsulosin - Low Dose Level (Steady State - PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
673783|NCT00340678|B5|Baseline|Total|Total of all reporting groups
673784|NCT00340678|B4|Baseline|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
673785|NCT00340678|B3|Baseline|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673786|NCT00340678|B2|Baseline|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
673787|NCT00340678|B1|Baseline|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673788|NCT00340678|P4|Participant Flow|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
673789|NCT00340678|P3|Participant Flow|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673790|NCT00340678|P2|Participant Flow|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
673791|NCT00340678|P1|Participant Flow|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673792|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
673793|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673794|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
673795|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673796|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
673797|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673798|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
673799|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
673800|NCT00340678|E2|Reported Event|Placebo|Subjects received placebo
673801|NCT00340678|E1|Reported Event|Losartan|Subjects received losartan
673802|NCT00340379|B3|Baseline|Total|Total of all reporting groups
673803|NCT00340379|B2|Baseline|Sertraline/Haloperidol|
673804|NCT00340379|B1|Baseline|Ziprasidone|
673827|NCT00339183|B2|Baseline|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
673828|NCT00339183|B1|Baseline|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
673829|NCT00339183|P2|Participant Flow|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
673830|NCT00339183|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
673831|NCT00339183|O2|Outcome|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673832|NCT00339183|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
673833|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673834|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673835|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673836|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673837|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673838|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673839|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673840|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673841|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673842|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673843|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673844|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673845|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673846|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673847|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673848|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673849|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673850|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673851|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673852|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673853|NCT00339183|E2|Reported Event|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
673854|NCT00339183|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
673855|NCT00339144|B4|Baseline|Total|Total of all reporting groups
673856|NCT00339144|B3|Baseline|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673857|NCT00339144|B2|Baseline|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673969|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673858|NCT00339144|B1|Baseline|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673859|NCT00339144|P3|Participant Flow|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673860|NCT00339144|P2|Participant Flow|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673861|NCT00339144|P1|Participant Flow|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673862|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673863|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673864|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673865|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673866|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673867|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673868|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
673869|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
673947|NCT00339079|P4|Participant Flow|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
674032|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
673870|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673871|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673872|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673873|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673874|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673875|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673876|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673877|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673878|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673879|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673880|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673881|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673882|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673883|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673884|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673885|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673886|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673887|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673888|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673889|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673890|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673891|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673892|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673893|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673894|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673948|NCT00339079|P3|Participant Flow|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
673895|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673896|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673897|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673898|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673899|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673900|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673901|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673902|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673903|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673904|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673905|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673906|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673949|NCT00339079|P2|Participant Flow|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
673950|NCT00339079|P1|Participant Flow|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
673907|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673908|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673909|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673910|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673911|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673912|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673913|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673914|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673915|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673916|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673917|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673918|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673965|NCT00339040|B1|Baseline|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673966|NCT00339040|P2|Participant Flow|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673919|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673920|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673921|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673922|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673923|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673924|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673925|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673926|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673927|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673928|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673929|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673930|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673967|NCT00339040|P1|Participant Flow|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673968|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673931|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673932|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673933|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673934|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673935|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673936|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673937|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673938|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673939|NCT00339144|E3|Reported Event|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
673940|NCT00339144|E2|Reported Event|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673941|NCT00339144|E1|Reported Event|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
673942|NCT00339079|B5|Baseline|Total|Total of all reporting groups
673943|NCT00339079|B4|Baseline|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when administered alone in the other arms.
673944|NCT00339079|B3|Baseline|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter.
673945|NCT00339079|B2|Baseline|Placebo|Patients only received placebo pills
673946|NCT00339079|B1|Baseline|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
673951|NCT00339079|O4|Outcome|Combined CBT and Fluoxetine|"Patients arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.~Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes wi"
673952|NCT00339079|O3|Outcome|Fluoxetine|"Patients received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.~Supportiv"
673953|NCT00339079|O2|Outcome|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.~Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
673954|NCT00339079|O1|Outcome|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
673955|NCT00339079|O4|Outcome|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
673956|NCT00339079|O3|Outcome|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
673957|NCT00339079|O2|Outcome|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
673958|NCT00339079|O1|Outcome|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
673959|NCT00339079|E4|Reported Event|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
673960|NCT00339079|E3|Reported Event|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
673961|NCT00339079|E2|Reported Event|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.~Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
673962|NCT00339079|E1|Reported Event|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
673963|NCT00339040|B3|Baseline|Total|Total of all reporting groups
673964|NCT00339040|B2|Baseline|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673970|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673971|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673972|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673973|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673974|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673975|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673976|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673977|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673978|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673979|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673980|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673981|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673982|NCT00339040|E2|Reported Event|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
673983|NCT00339040|E1|Reported Event|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
673984|NCT00338988|B1|Baseline|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
673985|NCT00338988|P1|Participant Flow|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
673986|NCT00338988|O1|Outcome|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
673987|NCT00338988|E2|Reported Event|Stratum 2: No Prior Therapy|Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
673988|NCT00338988|E1|Reported Event|Stratum: 1 Prior Regimen|Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
673989|NCT00338962|B5|Baseline|Total|Total of all reporting groups
673990|NCT00338962|B4|Baseline|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
673991|NCT00338962|B3|Baseline|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
673992|NCT00338962|B2|Baseline|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
673993|NCT00338962|B1|Baseline|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
673994|NCT00338962|P4|Participant Flow|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
673995|NCT00338962|P3|Participant Flow|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
673996|NCT00338962|P2|Participant Flow|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
673997|NCT00338962|P1|Participant Flow|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
673998|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
673999|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
674033|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674000|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
674001|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
674002|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
674003|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
674004|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
674005|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
674006|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
674007|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
674008|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
674009|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
674010|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
674011|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
674012|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
674013|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
674014|NCT00338962|E4|Reported Event|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
674015|NCT00338962|E3|Reported Event|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
674016|NCT00338962|E2|Reported Event|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
674017|NCT00338962|E1|Reported Event|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
674018|NCT00338884|B1|Baseline|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674019|NCT00338884|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674020|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674021|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674022|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674023|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674024|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674025|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674026|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674027|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674028|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674029|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674030|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674031|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674342|NCT00337610|B3|Baseline|Total|Total of all reporting groups
674034|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674035|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674036|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674037|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674038|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674039|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674040|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674041|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674042|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674043|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674044|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674045|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674046|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674047|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674048|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674049|NCT00338884|E1|Reported Event|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
674050|NCT00338806|B3|Baseline|Total|Total of all reporting groups
674051|NCT00338806|B2|Baseline|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674052|NCT00338806|B1|Baseline|IPT- Prevention for Adolescents|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674053|NCT00338806|P2|Participant Flow|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674054|NCT00338806|P1|Participant Flow|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674055|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674056|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674057|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674058|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674059|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674060|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674061|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674062|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674063|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674064|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674065|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674066|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674067|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674068|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674069|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674070|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674071|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674072|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674073|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674074|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674075|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674076|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674077|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674078|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674079|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674080|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674081|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674082|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674083|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674084|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674085|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674086|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674087|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674088|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674089|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674090|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674091|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674092|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674093|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674094|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674095|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674096|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674097|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674098|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674099|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674100|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674101|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674102|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674103|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674104|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674105|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674106|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674107|NCT00338806|O2|Outcome|Educational and Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674108|NCT00338806|O1|Outcome|Interpersonal Psychotherapy-Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674109|NCT00338806|O2|Outcome|Educational Clinical Monitoring|Participants will receive educational clinical monitoring consisting of sessions of psychoeducation about mood disorders and monthly visits with a study therapist.
674110|NCT00338806|O1|Outcome|Interpersonal Psychotherapy for Prevention|Participants will receive 12 sessions of interpersonal psychotherapy for prevention of a mood disorder
674111|NCT00338806|E2|Reported Event|Educational Clinical Monitoring|"Participants will receive educational clinical monitoring~Educational clinical monitoring: Educational clinical monitoring will include two individual sessions of psychoeducation on mood disorders with the adolescent followed by monthly (and if needed bimonthly) meetings with therapist. If more sessions are required, a referral will be made."
674112|NCT00338806|E1|Reported Event|Interpersonal Psychotherapy for Prevention|"Participants will receive interpersonal psychotherapy for prevention with adolescents~Interpersonal psychotherapy for prevention with adolescents: Individual interpersonal psychotherapy with the adolescents will be conducted over 12 weeks and will include a family psychoeducation component."
674113|NCT00338741|B3|Baseline|Total|Total of all reporting groups
674114|NCT00338741|B2|Baseline|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
674115|NCT00338741|B1|Baseline|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
674116|NCT00338741|P2|Participant Flow|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
674117|NCT00338741|P1|Participant Flow|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
674118|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
674119|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
674120|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
674121|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
674122|NCT00338741|E2|Reported Event|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
674123|NCT00338741|E1|Reported Event|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
674124|NCT00338598|B3|Baseline|Total|Total of all reporting groups
674125|NCT00338598|B2|Baseline|Placebo|"placebo will be administered.~placebo"
674126|NCT00338598|B1|Baseline|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674127|NCT00338598|P2|Participant Flow|Placebo|"placebo will be administered.~placebo"
674128|NCT00338598|P1|Participant Flow|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674129|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
674130|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674131|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
674132|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674133|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
674134|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674135|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
674136|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674137|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
674138|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674139|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
674140|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674141|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
674142|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674143|NCT00338598|E2|Reported Event|Placebo|"placebo will be administered.~placebo"
674144|NCT00338598|E1|Reported Event|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
674145|NCT00338455|B3|Baseline|Total|Total of all reporting groups
674146|NCT00338455|B2|Baseline|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674147|NCT00338455|B1|Baseline|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674148|NCT00338455|P2|Participant Flow|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674149|NCT00338455|P1|Participant Flow|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674150|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674151|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674152|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674153|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674154|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674155|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674156|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674157|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674158|NCT00338455|E2|Reported Event|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674159|NCT00338455|E1|Reported Event|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
674160|NCT00338286|B3|Baseline|Total|Total of all reporting groups
674161|NCT00338286|B2|Baseline|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674162|NCT00338286|B1|Baseline|Standard Supportive Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion
674163|NCT00338286|P2|Participant Flow|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674164|NCT00338286|P1|Participant Flow|Standard Supportive Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion
674165|NCT00338286|O2|Outcome|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674166|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
674167|NCT00338286|O2|Outcome|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674168|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
674169|NCT00338286|O2|Outcome|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674170|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
674171|NCT00338286|O2|Outcome|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674172|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
674173|NCT00338286|O2|Outcome|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674174|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
674175|NCT00338286|E2|Reported Event|Epoetin Alfa|Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
674176|NCT00338286|E1|Reported Event|Standard Supportive Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion
674177|NCT00338104|B4|Baseline|Total|Total of all reporting groups
674178|NCT00338104|B3|Baseline|80% Group|Glargine at 80% of insulin drip rate
674179|NCT00338104|B2|Baseline|60% Group|Glargine at 60% of insulin drip rate
674180|NCT00338104|B1|Baseline|40% Group|Glargine at 40% of insulin drip rate
674181|NCT00338104|P3|Participant Flow|80% Group|Glargine at 80% of insulin drip rate
674182|NCT00338104|P2|Participant Flow|60% Group|Glargine at 60% of insulin drip rate
674183|NCT00338104|P1|Participant Flow|40% Group|Glargine at 40% of insulin drip rate
674184|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
674185|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
674186|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
674187|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
674188|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
674189|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
674190|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
674191|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
674192|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
674193|NCT00338039|B1|Baseline|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
674194|NCT00338039|P1|Participant Flow|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Grey delivered in 28 fractions.
674195|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
674196|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
674197|NCT00338039|E1|Reported Event|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
674198|NCT00337987|B1|Baseline|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
674199|NCT00337987|P1|Participant Flow|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
674200|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
674201|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
674202|NCT00337987|E1|Reported Event|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
674203|NCT00337935|B3|Baseline|Total|Total of all reporting groups
674204|NCT00337935|B2|Baseline|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
674205|NCT00337935|B1|Baseline|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
674206|NCT00337935|P2|Participant Flow|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
674207|NCT00337935|P1|Participant Flow|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
674208|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
674209|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs). Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.
674210|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
674211|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
674212|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
674213|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
674214|NCT00337935|E2|Reported Event|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
674215|NCT00337935|E1|Reported Event|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
674216|NCT00337818|B4|Baseline|Total|Total of all reporting groups
674217|NCT00337818|B3|Baseline|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674218|NCT00337818|B2|Baseline|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674219|NCT00337818|B1|Baseline|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674220|NCT00337818|P3|Participant Flow|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674221|NCT00337818|P2|Participant Flow|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674222|NCT00337818|P1|Participant Flow|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674223|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674224|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674225|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674226|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674227|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674228|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674229|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674230|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674231|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674232|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674981|NCT00335257|P2|Participant Flow|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
674233|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674234|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674235|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674236|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674237|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674238|NCT00337818|E3|Reported Event|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674239|NCT00337818|E2|Reported Event|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
674240|NCT00337818|E1|Reported Event|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
674241|NCT00337779|B3|Baseline|Total|Total of all reporting groups
674242|NCT00337779|B2|Baseline|Glatiramer Acetate 40 mg|
674243|NCT00337779|B1|Baseline|Glatiramer Acetate 20 mg|
674244|NCT00337779|P2|Participant Flow|Glatiramer Acetate 40 mg|
674245|NCT00337779|P1|Participant Flow|Glatiramer Acetate 20 mg|
674246|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
674247|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
674248|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
674249|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
674250|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
674251|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
674252|NCT00337779|E2|Reported Event|Glatiramer Acetate 40 mg|
674253|NCT00337779|E1|Reported Event|Glatiramer Acetate 20 mg|
674254|NCT00337727|B3|Baseline|Total|Total of all reporting groups
674255|NCT00337727|B2|Baseline|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
674256|NCT00337727|B1|Baseline|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
674257|NCT00337727|P2|Participant Flow|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
674258|NCT00337727|P1|Participant Flow|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
674259|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
674260|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
674261|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
674262|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
674263|NCT00337727|E2|Reported Event|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
674264|NCT00337727|E1|Reported Event|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
674265|NCT00337675|B4|Baseline|Total|Total of all reporting groups
674266|NCT00337675|B3|Baseline|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674267|NCT00337675|B2|Baseline|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674268|NCT00337675|B1|Baseline|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674269|NCT00337675|P3|Participant Flow|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674270|NCT00337675|P2|Participant Flow|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674982|NCT00335257|P1|Participant Flow|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen)
674271|NCT00337675|P1|Participant Flow|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674272|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674273|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674274|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674275|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674276|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674277|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674278|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674279|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674280|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674281|NCT00337675|E3|Reported Event|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674282|NCT00337675|E2|Reported Event|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674283|NCT00337675|E1|Reported Event|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
674284|NCT00337662|B4|Baseline|Total|Total of all reporting groups
674285|NCT00337662|B3|Baseline|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674286|NCT00337662|B2|Baseline|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674287|NCT00337662|B1|Baseline|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674288|NCT00337662|P4|Participant Flow|Risperiodone Open-Label Lead-In|"All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II.~Risperidone: 2-6 mg, oral, daily"
674289|NCT00337662|P3|Participant Flow|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674290|NCT00337662|P2|Participant Flow|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674291|NCT00337662|P1|Participant Flow|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674292|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674293|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674983|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception
674294|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674295|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674296|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674297|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674298|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674299|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674300|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674301|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674302|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674303|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674304|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674305|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674306|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674307|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674308|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674309|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674310|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674311|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674312|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674313|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674314|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674315|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674316|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674317|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674318|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674319|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674320|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674321|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674322|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674323|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674324|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674325|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674326|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674327|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674328|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674329|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674330|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674331|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674332|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674333|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674334|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674335|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
674336|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674337|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674338|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
674339|NCT00337662|E3|Reported Event|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
674340|NCT00337662|E2|Reported Event|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
674341|NCT00337662|E1|Reported Event|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks.
674343|NCT00337610|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674344|NCT00337610|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674345|NCT00337610|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674346|NCT00337610|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674347|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674348|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674349|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674350|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674351|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674352|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674353|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674354|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674355|NCT00337610|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674356|NCT00337610|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
674357|NCT00337571|B5|Baseline|Total|Total of all reporting groups
674358|NCT00337571|B4|Baseline|Aripiprazole 15 mg|
674359|NCT00337571|B3|Baseline|Aripiprazole 10 mg|
674360|NCT00337571|B2|Baseline|Aripiprazole 5 mg|
674361|NCT00337571|B1|Baseline|Placebo|
674362|NCT00337571|P4|Participant Flow|Aripiprazole 15 mg|
674363|NCT00337571|P3|Participant Flow|Aripiprazole 10 mg|
674364|NCT00337571|P2|Participant Flow|Aripiprazole 5 mg|
674365|NCT00337571|P1|Participant Flow|Placebo|
674366|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674367|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674368|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674369|NCT00337571|O1|Outcome|Placebo|
674370|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674371|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674372|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674373|NCT00337571|O1|Outcome|Placebo|
674374|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674375|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674376|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674377|NCT00337571|O1|Outcome|Placebo|
674378|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674379|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674380|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674381|NCT00337571|O1|Outcome|Placebo|
674382|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674383|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674384|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674385|NCT00337571|O1|Outcome|Placebo|
674386|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674387|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674388|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674389|NCT00337571|O1|Outcome|Placebo|
674390|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674391|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674392|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674393|NCT00337571|O1|Outcome|Placebo|
674394|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
674395|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
674396|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
674397|NCT00337571|O1|Outcome|Placebo|
674398|NCT00337571|E4|Reported Event|Placebo|
674399|NCT00337571|E3|Reported Event|Aripiprazole 5 mg|
674400|NCT00337571|E2|Reported Event|Aripiprazole 15 mg|
674401|NCT00337571|E1|Reported Event|Aripiprazole 10 mg|
674402|NCT00337467|B1|Baseline|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674403|NCT00337467|P1|Participant Flow|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674404|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674405|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674406|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674407|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674408|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674409|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674410|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674411|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674412|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without virologic rebound at the end of interval
674413|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without treatment failure at the end of interval
674414|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674415|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674416|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674417|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674418|NCT00337467|E1|Reported Event|ATV/RTV Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
674419|NCT00337428|B3|Baseline|Total|Total of all reporting groups
674420|NCT00337428|B2|Baseline|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674421|NCT00337428|B1|Baseline|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674422|NCT00337428|P2|Participant Flow|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674423|NCT00337428|P1|Participant Flow|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674424|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674425|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674426|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674427|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674428|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674429|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674430|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674431|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674432|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674433|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674434|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
675113|NCT00334633|E3|Reported Event|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
674435|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674436|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674437|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674438|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674439|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674440|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674441|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674442|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674443|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674444|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674445|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674446|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674447|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674448|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674449|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674450|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674451|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674452|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674453|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674454|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674455|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674456|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674457|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674458|NCT00337428|E2|Reported Event|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
674459|NCT00337428|E1|Reported Event|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
674460|NCT00337350|B3|Baseline|Total|Total of all reporting groups
674461|NCT00337350|B2|Baseline|Placebo|matched placebo for rosiglitazone 4mg/day
674462|NCT00337350|B1|Baseline|Rosiglitazone|rosiglitazone 4mg/day
674463|NCT00337350|P2|Participant Flow|Placebo|matched placebo for rosiglitazone 4mg/day
674464|NCT00337350|P1|Participant Flow|Rosiglitazone|rosiglitazone 4mg/day
674465|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
674466|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
674467|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
674468|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
674469|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
674470|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
674471|NCT00337350|E2|Reported Event|Placebo|matched placebo for rosiglitazone 4mg/day
674472|NCT00337350|E1|Reported Event|Rosiglitazone|rosiglitazone 4mg/day
674473|NCT00337285|B1|Baseline|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
674474|NCT00337285|P1|Participant Flow|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
674475|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
674476|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
674477|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
674478|NCT00337285|E1|Reported Event|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
674479|NCT00337272|B3|Baseline|Total|Total of all reporting groups
674480|NCT00337272|B2|Baseline|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674481|NCT00337272|B1|Baseline|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674482|NCT00337272|P2|Participant Flow|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674483|NCT00337272|P1|Participant Flow|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674484|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674485|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674486|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674487|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674488|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674489|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674490|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674491|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674492|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674493|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674494|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674495|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674496|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674497|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674498|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674499|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674500|NCT00337272|E2|Reported Event|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
674501|NCT00337272|E1|Reported Event|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
674502|NCT00337207|B1|Baseline|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
674503|NCT00337207|P1|Participant Flow|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
674504|NCT00337207|O1|Outcome|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
674505|NCT00337207|E1|Reported Event|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
674506|NCT00337194|B3|Baseline|Total|Total of all reporting groups
674507|NCT00337194|B2|Baseline|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674508|NCT00337194|B1|Baseline|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674509|NCT00337194|P2|Participant Flow|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674557|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674510|NCT00337194|P1|Participant Flow|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674511|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
674512|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
674513|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
674514|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
674515|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674516|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674517|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674518|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674519|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674520|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674521|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674558|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674591|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674522|NCT00337194|E2|Reported Event|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharma"
674523|NCT00337194|E1|Reported Event|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
674524|NCT00337168|B1|Baseline|Induction|
674525|NCT00337168|P1|Participant Flow|Induction|Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
674526|NCT00337168|O1|Outcome|Induction|Up to two induction cycles with clofarabine and cytarabine
674527|NCT00337168|O1|Outcome|Induction|
674528|NCT00337168|O1|Outcome|Induction|
674529|NCT00337168|O1|Outcome|Induction|
674530|NCT00337168|E1|Reported Event|Induction|Up to two induction cycles with clofarabine and cytarabine
674531|NCT00337129|B1|Baseline|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
674532|NCT00337129|P1|Participant Flow|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
674533|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
674534|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
674535|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
674536|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
674537|NCT00337129|E1|Reported Event|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
674538|NCT00337103|B3|Baseline|Total|Total of all reporting groups
674539|NCT00337103|B2|Baseline|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
674540|NCT00337103|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
674541|NCT00337103|P2|Participant Flow|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
674542|NCT00337103|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
674543|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
674544|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
674545|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
674546|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
674547|NCT00337103|E2|Reported Event|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
674548|NCT00337103|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
674549|NCT00337077|B4|Baseline|Total|Total of all reporting groups
674550|NCT00337077|B3|Baseline|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674551|NCT00337077|B2|Baseline|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674552|NCT00337077|B1|Baseline|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674553|NCT00337077|P3|Participant Flow|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674554|NCT00337077|P2|Participant Flow|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674555|NCT00337077|P1|Participant Flow|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674556|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
675114|NCT00334633|E2|Reported Event|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
674559|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674560|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674561|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
674562|NCT00337077|E1|Reported Event|Eribulin Mesylate|All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
674563|NCT00336973|B1|Baseline|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
674564|NCT00336973|P1|Participant Flow|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
674565|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
674566|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
674567|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
674568|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
674569|NCT00336895|B1|Baseline|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
674570|NCT00336895|P1|Participant Flow|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
674571|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
674572|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
674573|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
674574|NCT00336895|E1|Reported Event|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
674575|NCT00336856|B1|Baseline|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC who received Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV), followed by 500 mg/m2 every 2 weeks IV
674576|NCT00336856|P1|Participant Flow|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC
674577|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
674578|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
674579|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
674580|NCT00336856|E1|Reported Event|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
674581|NCT00336817|B3|Baseline|Total|Total of all reporting groups
674582|NCT00336817|B2|Baseline|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674583|NCT00336817|B1|Baseline|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674584|NCT00336817|P2|Participant Flow|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674585|NCT00336817|P1|Participant Flow|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674586|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674587|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674588|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674589|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674590|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674592|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days~Results: 2 participants in the CellCept group discontinued drug use"
674593|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days~Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis"
674594|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days~Results: 2 participants in the CellCept group discontinued drug use"
674595|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days~Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis"
674596|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674597|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674598|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674599|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674600|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674601|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674602|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674603|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674604|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674605|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674606|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674607|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674608|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674609|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674610|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674611|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674612|NCT00336817|E2|Reported Event|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
674613|NCT00336817|E1|Reported Event|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
674614|NCT00336700|B1|Baseline|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674615|NCT00336700|P1|Participant Flow|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674616|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674617|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674618|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674619|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674620|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674621|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
674622|NCT00336700|E1|Reported Event|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|
674713|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674623|NCT00336583|B1|Baseline|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
674624|NCT00336583|P1|Participant Flow|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
674625|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
674626|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
674627|NCT00336583|E1|Reported Event|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
674628|NCT00336544|B3|Baseline|Total|Total of all reporting groups
674629|NCT00336544|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674630|NCT00336544|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674631|NCT00336544|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674632|NCT00336544|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674633|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674634|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674635|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674636|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674637|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674638|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674639|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674640|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674641|NCT00336544|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674642|NCT00336544|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674643|NCT00336505|B3|Baseline|Total|Total of all reporting groups
674644|NCT00336505|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674645|NCT00336505|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674646|NCT00336505|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674647|NCT00336505|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674648|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674649|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674650|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674651|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674652|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674653|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674654|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674655|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674656|NCT00336505|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
674657|NCT00336505|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
674658|NCT00336492|B4|Baseline|Total|Total of all reporting groups
674659|NCT00336492|B3|Baseline|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
674660|NCT00336492|B2|Baseline|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
674661|NCT00336492|B1|Baseline|Not Randomized Group|Participants who were not randomized at Week 8
674662|NCT00336492|P3|Participant Flow|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
674663|NCT00336492|P2|Participant Flow|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
674664|NCT00336492|P1|Participant Flow|Not Randomized Group|Participants who were not randomized at Week 8
674665|NCT00336492|O2|Outcome|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
674666|NCT00336492|O1|Outcome|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
674667|NCT00336492|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg group
674668|NCT00336492|E3|Reported Event|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
674669|NCT00336492|E2|Reported Event|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
674670|NCT00336492|E1|Reported Event|Not Randomized Group|Participants who were not randomized at Week 8
674671|NCT00336479|B5|Baseline|Total|Total of all reporting groups
674714|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674715|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674672|NCT00336479|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
674673|NCT00336479|B3|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
674674|NCT00336479|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
674675|NCT00336479|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
674676|NCT00336479|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
674677|NCT00336479|P3|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
674678|NCT00336479|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
674679|NCT00336479|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
674680|NCT00336479|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week”, “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, and “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
674681|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
674682|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
674683|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
674684|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
674685|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
674686|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
674687|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
674688|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
674689|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
674690|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
674691|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
674692|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
674693|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
674694|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
674695|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
674696|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
674697|NCT00336479|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
674698|NCT00336479|E3|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
674699|NCT00336479|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
674700|NCT00336479|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
674701|NCT00336323|B6|Baseline|Total|Total of all reporting groups
674702|NCT00336323|B5|Baseline|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
674703|NCT00336323|B4|Baseline|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
674704|NCT00336323|B3|Baseline|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674705|NCT00336323|B2|Baseline|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674706|NCT00336323|B1|Baseline|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
674707|NCT00336323|P5|Participant Flow|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
674708|NCT00336323|P4|Participant Flow|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
674709|NCT00336323|P3|Participant Flow|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674710|NCT00336323|P2|Participant Flow|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674711|NCT00336323|P1|Participant Flow|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
674712|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674716|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674717|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674718|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674719|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674720|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674721|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
674722|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
674723|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
674724|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674725|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674726|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674727|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674728|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674729|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674730|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674731|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674732|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674733|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674734|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674735|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674736|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674737|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674738|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674739|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
674740|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
674741|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
674742|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674743|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674744|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
674745|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
674746|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
674747|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674748|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674749|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
674750|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
674751|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
674752|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674753|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674754|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
674755|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
674756|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
674757|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674758|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674759|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
674760|NCT00336323|E5|Reported Event|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
674761|NCT00336323|E4|Reported Event|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
674762|NCT00336323|E3|Reported Event|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674763|NCT00336323|E2|Reported Event|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
674764|NCT00336323|E1|Reported Event|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
674765|NCT00336284|B3|Baseline|Total|Total of all reporting groups
674766|NCT00336284|B2|Baseline|Conventional|Home Monitoring programmed OFF
674767|NCT00336284|B1|Baseline|Home Monitoring|Home Monitoring programmed ON
674768|NCT00336284|P2|Participant Flow|Conventional|Home Monitoring programmed OFF
674769|NCT00336284|P1|Participant Flow|Home Monitoring|Home Monitoring programmed ON
674770|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
674771|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
674772|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
674773|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
674774|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
674775|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
674776|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
674777|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
674778|NCT00336284|E2|Reported Event|Conventional|Home Monitoring programmed OFF
674779|NCT00336284|E1|Reported Event|Home Monitoring|Home Monitoring programmed ON
674780|NCT00336232|B1|Baseline|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
674781|NCT00336232|P1|Participant Flow|Vitamin K Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
674782|NCT00336232|O1|Outcome|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
674783|NCT00336232|E1|Reported Event|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
674784|NCT00335972|B3|Baseline|Total|Total of all reporting groups
674785|NCT00335972|B2|Baseline|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
674786|NCT00335972|B1|Baseline|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
674787|NCT00335972|P2|Participant Flow|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
674788|NCT00335972|P1|Participant Flow|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
674789|NCT00335972|O2|Outcome|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
674790|NCT00335972|O1|Outcome|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
674791|NCT00335972|O2|Outcome|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
674792|NCT00335972|O1|Outcome|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
674793|NCT00335972|O2|Outcome|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
674794|NCT00335972|O1|Outcome|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
674795|NCT00335972|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.~Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical."
674796|NCT00335972|E1|Reported Event|Remifentanil|"Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical~Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical"
674797|NCT00335959|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
674798|NCT00335959|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
674799|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
674800|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
674801|NCT00335959|E1|Reported Event|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
674802|NCT00335829|B1|Baseline|Single Arm, Received Bevacizumab and TACE|"bevacizumab~chemotherapy~embolization therapy~hepatic artery infusion"
674803|NCT00335829|P1|Participant Flow|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674804|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674805|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674806|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674807|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674808|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674809|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674810|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674811|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674812|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674813|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674814|NCT00335829|O1|Outcome|Single Arm, Received Bevacizumab and TACE|Patients received intravenous bevacizumab (10mg/kg) and chemoembolization for up to 3 cycles over 6 months. After completion of last treatment cycle, follow-up including clinic visits and imaging was performed every 8 to 12 weeks.
674815|NCT00335829|E1|Reported Event|Single Arm, Received Bevacizumab and TACE|"bevacizumab~chemotherapy~embolization therapy~hepatic artery infusion"
674816|NCT00335777|B1|Baseline|Migranal: All Subjects|All subjects enrolled in study
674817|NCT00335777|P1|Participant Flow|Migranal: All Subjects|All subjects enrolled in study
674818|NCT00335777|O2|Outcome|Migranal Late Treatment|Treated a headache at greater or equal to 3.5 hours after onset of throbbing
674819|NCT00335777|O1|Outcome|Migranal: Early Treatment|Treated headache within 1.25 hours of onset of throbbing
674820|NCT00335777|E1|Reported Event|Migranal: All Subjects|All subjects enrolled in study
674821|NCT00335738|B3|Baseline|Total|Total of all reporting groups
674822|NCT00335738|B2|Baseline|Group 2 (Not High Risk)|Patients undergo observation periodically for at least 5 years.
674823|NCT00335738|B1|Baseline|Group 1 (High Risk)|"Patients receive liposomal vincristine sulfate IV aged based dosage (Pts < 36 mos: 0.05 mg/kg, Pts > 36 mos: 1.5 mg/m2, max dose 2 MG) given IV or infusion on day 1, carboplatin aged based dosage (Pts < 36 mos: 18.6 mg/kg Pts > 36 mos: 560 mg/m2) IV on day 1, and Etoposide aged based dosage (Pts < 36 mos: 5 mg/kg, Pts > 36 mos: 150 mg/m2) IV on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~liposomal vincristine sulfate: Given IV~carboplatin: Given IV~etoposide: Given IV"
674824|NCT00335738|P2|Participant Flow|Group 2 (Identified by Central Review as Not High Risk)|Patients undergo observation periodically for at least 5 years.
674865|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674866|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide;x 30 weeks; XRT.
674825|NCT00335738|P1|Participant Flow|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
674826|NCT00335738|O1|Outcome|All Patients|This outcome measure is calculated by combining all groups as defined in the trials record.
674827|NCT00335738|O1|Outcome|All Patients|This outcome measure is calculated by combining all groups as defined in the trials record.
674828|NCT00335738|O1|Outcome|All Patients|This outcome measure is calculated by combining all groups as defined in the trials record.
674829|NCT00335738|O1|Outcome|All Patients|This outcome measure is calculated by combining all groups as defined in the trials record.
674830|NCT00335738|O1|Outcome|All Patients|This outcome measure is calculated by combining all groups as defined in the trials record.
674831|NCT00335738|O1|Outcome|All Patients|This outcome measure is calculated by combining all groups as defined in the trials record.
674832|NCT00335738|O1|Outcome|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
674833|NCT00335738|O2|Outcome|Group 2 (Identified by Central Review as Not High Risk)|Patients undergo observation periodically for at least 5 years.
674834|NCT00335738|O1|Outcome|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
674835|NCT00335738|O2|Outcome|Group 2 (Identified by Central Review as Not High Risk)|Patients undergo observation periodically for at least 5 years.
674836|NCT00335738|O1|Outcome|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
674837|NCT00335738|E2|Reported Event|Group 2 (Identified by Central Review as Not High Risk)|Patients undergo observation periodically for at least 5 years.
674838|NCT00335738|E1|Reported Event|Group 1 (Identified by Central Review as High Risk)|Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
674839|NCT00335725|B3|Baseline|Total|Total of all reporting groups
674840|NCT00335725|B2|Baseline|Gonal-f|
674841|NCT00335725|B1|Baseline|Fostimon|
674842|NCT00335725|P2|Participant Flow|Gonal-f|Recombinant FSH
674843|NCT00335725|P1|Participant Flow|Fostimon|Highly purified FSH
674844|NCT00335725|O2|Outcome|Gonal-F|
674845|NCT00335725|O1|Outcome|Fostimon|
674846|NCT00335725|O2|Outcome|Gonal-f|
674847|NCT00335725|O1|Outcome|Fostimon|
674848|NCT00335725|E2|Reported Event|Gonal-F|
674849|NCT00335725|E1|Reported Event|Fostimon|
674850|NCT00335556|B7|Baseline|Total|Total of all reporting groups
674851|NCT00335556|B6|Baseline|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
674852|NCT00335556|B5|Baseline|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
674853|NCT00335556|B4|Baseline|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
674854|NCT00335556|B3|Baseline|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674855|NCT00335556|B2|Baseline|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674856|NCT00335556|B1|Baseline|Surgery|Surgery Only
674857|NCT00335556|P6|Participant Flow|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
674858|NCT00335556|P5|Participant Flow|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
674859|NCT00335556|P4|Participant Flow|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
674860|NCT00335556|P3|Participant Flow|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674861|NCT00335556|P2|Participant Flow|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674862|NCT00335556|P1|Participant Flow|Surgery|Surgery Only
674863|NCT00335556|O4|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
674864|NCT00335556|O3|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
674920|NCT00335452|B4|Baseline|Clopidogrel 600/150/75 mg + ASA High Dose|
674867|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674868|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674869|NCT00335556|O1|Outcome|Combined UH-2, UH-1, Window/UH-1|Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring
674870|NCT00335556|O1|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
674871|NCT00335556|O1|Outcome|Combined Window/UH-1 and UH-2|Combine window/UH-1 and UH-2 for response rate monitoring for window therapy.
674872|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphamide; x 30 weeks; XRT.
674873|NCT00335556|O3|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
674874|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674875|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
674876|NCT00335556|E6|Reported Event|Regimen DD-4A|"Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
674877|NCT00335556|E5|Reported Event|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT
674878|NCT00335556|E4|Reported Event|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
674879|NCT00335556|E3|Reported Event|Window/UH-1|"Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"
674880|NCT00335556|E2|Reported Event|UH-1|Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT
674881|NCT00335556|E1|Reported Event|Surgery|Surgery Only
674882|NCT00335517|B1|Baseline|Injection|DepoDur Injection
674883|NCT00335517|P1|Participant Flow|Injection|DepoDur Injection
674884|NCT00335517|O1|Outcome|Injection|DepoDur Injection
674885|NCT00335517|E1|Reported Event|Injection|DepoDur Injection
674886|NCT00335504|B5|Baseline|Total|Total of all reporting groups
674887|NCT00335504|B4|Baseline|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
674888|NCT00335504|B3|Baseline|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
674889|NCT00335504|B2|Baseline|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
674890|NCT00335504|B1|Baseline|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
674891|NCT00335504|P4|Participant Flow|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
674892|NCT00335504|P3|Participant Flow|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
674893|NCT00335504|P2|Participant Flow|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
674894|NCT00335504|P1|Participant Flow|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
674895|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
674896|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
674897|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
674898|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
674899|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
674900|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
674901|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
674902|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
674903|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
674904|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
674905|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
674906|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
674907|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
674908|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
674909|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
674910|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
674911|NCT00335504|E4|Reported Event|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
674912|NCT00335504|E3|Reported Event|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
674913|NCT00335504|E2|Reported Event|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
674914|NCT00335504|E1|Reported Event|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
674915|NCT00335478|B1|Baseline|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
674916|NCT00335478|P1|Participant Flow|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
674917|NCT00335478|O1|Outcome|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
674918|NCT00335478|E1|Reported Event|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
674919|NCT00335452|B5|Baseline|Total|Total of all reporting groups
674924|NCT00335452|P4|Participant Flow|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
674925|NCT00335452|P3|Participant Flow|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
674926|NCT00335452|P2|Participant Flow|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
674927|NCT00335452|P1|Participant Flow|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
674928|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
674929|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
674930|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
674931|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
674932|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
674933|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
674934|NCT00335452|O4|Outcome|Clopidogrel 600/150/75 mg + ASA High Dose|
674935|NCT00335452|O3|Outcome|Clopidogrel 600/150/75 mg + ASA Low Dose|
674936|NCT00335452|O2|Outcome|Clopidogrel 300/75/75 mg + ASA High Dose|
674937|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA Low Dose|
674938|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
674939|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
674940|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose.
674941|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
674942|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
674943|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
674944|NCT00335452|E4|Reported Event|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
674945|NCT00335452|E3|Reported Event|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
674946|NCT00335452|E2|Reported Event|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
674947|NCT00335452|E1|Reported Event|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
674948|NCT00335322|B4|Baseline|Total|Total of all reporting groups
674949|NCT00335322|B3|Baseline|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
674950|NCT00335322|B2|Baseline|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
674951|NCT00335322|B1|Baseline|TDF/FTC+EFV|
674952|NCT00335322|P3|Participant Flow|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
674953|NCT00335322|P2|Participant Flow|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
674954|NCT00335322|P1|Participant Flow|TDF/FTC+EFV|
674955|NCT00335322|O3|Outcome|TDF/FTC+AZT+ABC|
674956|NCT00335322|O2|Outcome|TDF/FTC+r/ATV|
674957|NCT00335322|O1|Outcome|TDF/FTC+EFV|
674958|NCT00335322|E3|Reported Event|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
674959|NCT00335322|E2|Reported Event|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
674960|NCT00335322|E1|Reported Event|TDF/FTC+EFV|
674961|NCT00335283|B3|Baseline|Total|Total of all reporting groups
674962|NCT00335283|B2|Baseline|Placebo (Sugar Pill)|one tablet twice a day
674963|NCT00335283|B1|Baseline|Lansoprazole|40 mg twice a day
674964|NCT00335283|P2|Participant Flow|Placebo (Sugar Pill)|one tablet twice a day
674965|NCT00335283|P1|Participant Flow|Lansoprazole|40 mg twice a day
674966|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
674967|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
674968|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
674969|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
674970|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
674971|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
674972|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
674973|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
674974|NCT00335283|E2|Reported Event|Placebo (Sugar Pill)|one tablet twice a day
674975|NCT00335283|E1|Reported Event|Lansoprazole|40 mg twice a day
674976|NCT00335257|B4|Baseline|Total|Total of all reporting groups
674977|NCT00335257|B3|Baseline|OCs Non-DRSP|Users of OCs containing other progestins
674978|NCT00335257|B2|Baseline|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
674984|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
674985|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins
674986|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
674987|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
674988|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception at last contact
674989|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
674990|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins than DRSP
674991|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
674992|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
674993|NCT00335257|E5|Reported Event|No Use|No (hormonal) contraception)
674994|NCT00335257|E4|Reported Event|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches)
674995|NCT00335257|E3|Reported Event|OCs Non-DRSP|Users of OCs containing other progestins
674996|NCT00335257|E2|Reported Event|DRSP-21d|21-day regimen of DRSP/EE
674997|NCT00335257|E1|Reported Event|DRSP-24d|24-day regimen of DRSP/EE
674998|NCT00335153|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
674999|NCT00335153|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675000|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675001|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675002|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675003|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675004|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675005|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675115|NCT00334633|E1|Reported Event|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
675116|NCT00334542|B1|Baseline|Simvastatin|Simvastatin 40 mg for 24-28 weeks
675006|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675007|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675008|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675009|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675010|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675011|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675012|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675013|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675014|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675015|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675117|NCT00334542|P1|Participant Flow|Simvastatin|Simvastatin 40 mg for 24-28 weeks
675118|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
675119|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
675120|NCT00334542|E1|Reported Event|Simvastatin|Simvastatin 40 mg for 24-28 weeks
675354|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675016|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675017|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675018|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675019|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675020|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675021|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675022|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675023|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675024|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675025|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675121|NCT00334295|B1|Baseline|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675122|NCT00334295|P1|Participant Flow|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675680|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
675026|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675027|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675028|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675029|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675030|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675031|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675032|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675033|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675034|NCT00335153|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
675035|NCT00335140|B1|Baseline|Rituximab + Standard Chemotherapy|"rituximab~cytarabine~dexamethasone~leucovorin calcium~methotrexate~procarbazine hydrochloride~vincristine sulfate"
675036|NCT00335140|P1|Participant Flow|Rituximab + Standard Chemotherapy|"rituximab~cytarabine~dexamethasone~leucovorin calcium~methotrexate~procarbazine hydrochloride~vincristine sulfate"
675037|NCT00335140|O1|Outcome|Rituximab + Standard Chemotherapy|"rituximab~cytarabine~dexamethasone~leucovorin calcium~methotrexate~procarbazine hydrochloride~vincristine sulfate"
675038|NCT00335140|E1|Reported Event|Rituximab + Standard Chemotherapy|Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
675039|NCT00334958|B3|Baseline|Total|Total of all reporting groups
675123|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675040|NCT00334958|B2|Baseline|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
675041|NCT00334958|B1|Baseline|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
675042|NCT00334958|P2|Participant Flow|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
675043|NCT00334958|P1|Participant Flow|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
675044|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
675045|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
675046|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
675047|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
675048|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
675049|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
675050|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
675051|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
675052|NCT00334958|E2|Reported Event|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
675355|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675053|NCT00334958|E1|Reported Event|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
675054|NCT00334893|B3|Baseline|Total|Total of all reporting groups
675055|NCT00334893|B2|Baseline|Platinum-Sensitive Cohort|Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
675056|NCT00334893|B1|Baseline|Platinum-Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675057|NCT00334893|P2|Participant Flow|Platinum Sensitive Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675058|NCT00334893|P1|Participant Flow|Platinum Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675059|NCT00334893|O2|Outcome|Platinum-Sensitive Cohort|Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
675060|NCT00334893|O1|Outcome|Platinum-Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675061|NCT00334893|O2|Outcome|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675062|NCT00334893|O1|Outcome|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675063|NCT00334893|E2|Reported Event|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675064|NCT00334893|E1|Reported Event|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
675065|NCT00334815|B3|Baseline|Total|Total of all reporting groups
675066|NCT00334815|B2|Baseline|High Risk Patient Stratum|
675067|NCT00334815|B1|Baseline|Low Risk Patient Stratum|
675068|NCT00334815|P2|Participant Flow|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675069|NCT00334815|P1|Participant Flow|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675070|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675071|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675072|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675073|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675124|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675356|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675074|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675075|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
675076|NCT00334815|O2|Outcome|Consolidation Therapy With Docetaxel and Bevacizumab.|
675077|NCT00334815|O1|Outcome|Concurrent Chemotherapy and Radiotherapy|
675078|NCT00334815|E2|Reported Event|Consolidation Therapy With Docetaxel and Bevacizumab|All eligible patients, both low-risk and high-risk strata combined, who received consolidation therapy with Docetaxel and Bevacizumab.
675079|NCT00334815|E1|Reported Event|Concurrent Chemotherapy and Radiotherapy|All eligible patients, both low-risk and high-risk strata combined, who received concurrent chemotherapy and radiotherapy.
675080|NCT00334802|B3|Baseline|Total|Total of all reporting groups
675081|NCT00334802|B2|Baseline|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675082|NCT00334802|B1|Baseline|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675083|NCT00334802|P2|Participant Flow|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675084|NCT00334802|P1|Participant Flow|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675085|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
675086|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
675087|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
675088|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
675089|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
675090|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
675091|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675092|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675093|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675094|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675095|NCT00334802|O1|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675096|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675097|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675098|NCT00334802|E2|Reported Event|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675099|NCT00334802|E1|Reported Event|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
675100|NCT00334633|B4|Baseline|Total|Total of all reporting groups
675101|NCT00334633|B3|Baseline|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
675102|NCT00334633|B2|Baseline|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
675103|NCT00334633|B1|Baseline|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
675104|NCT00334633|P3|Participant Flow|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
675105|NCT00334633|P2|Participant Flow|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
675106|NCT00334633|P1|Participant Flow|Metronidazole|metronidazole 500 twice a day (BID) for 7 days; 197 participants
675107|NCT00334633|O3|Outcome|Tinidazole 1 gm|"tinidazole 1 gm BID for 7 days~tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid"
675108|NCT00334633|O2|Outcome|Tinidazole 500|"tinidazole 500 BID for 7 days~tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid"
675109|NCT00334633|O1|Outcome|Control|"metronidazole 500 BID for 7 days~tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid"
675110|NCT00334633|O3|Outcome|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
675111|NCT00334633|O2|Outcome|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
675112|NCT00334633|O1|Outcome|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
675125|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675126|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675127|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675128|NCT00334295|E1|Reported Event|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
675129|NCT00334282|B3|Baseline|Total|Total of all reporting groups
675130|NCT00334282|B2|Baseline|Placebo|Matching Placebo administered once a day
675131|NCT00334282|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675132|NCT00334282|P2|Participant Flow|Placebo|Matching Placebo administered orally once a day
675133|NCT00334282|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675134|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
675135|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675136|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered once daily
675137|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
675138|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675139|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
675140|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675141|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
675142|NCT00334282|O1|Outcome|Pazopanib|Pazopanib 800 mg (tablets) administered orally once a day
675143|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675144|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675145|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
675146|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675147|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
675148|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675149|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
675150|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675151|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered once a day
675152|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675153|NCT00334282|E2|Reported Event|Placebo|Matching Placebo administered orally once a day
675154|NCT00334282|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
675155|NCT00334204|B1|Baseline|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
675156|NCT00334204|P1|Participant Flow|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
675157|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
675158|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
675159|NCT00334204|O1|Outcome|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
675160|NCT00334204|E1|Reported Event|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
675161|NCT00334113|B3|Baseline|Total|Total of all reporting groups
675162|NCT00334113|B2|Baseline|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
675163|NCT00334113|B1|Baseline|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
675164|NCT00334113|P2|Participant Flow|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
675165|NCT00334113|P1|Participant Flow|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
675347|NCT00333788|P1|Participant Flow|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675681|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
675166|NCT00334113|O2|Outcome|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
675167|NCT00334113|O1|Outcome|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
675168|NCT00334113|E2|Reported Event|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
675169|NCT00334113|E1|Reported Event|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
675170|NCT00334074|B1|Baseline|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
675171|NCT00334074|P1|Participant Flow|Clofarabine and Cytarabine|5 consecutive days of Clofarabine 40 mg/m^2 intravenous infusion over 1 hour followed 4 hours later by cytarabine 1000mg/m^2 intravenous infusion over 2 hours.Next cycle will start approximately 4 weeks after Day 1 of previous cycle. Patients will receive a maximum of 4 cycles of study treatment.
675172|NCT00334074|O1|Outcome|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
675173|NCT00334074|O1|Outcome|Clofarabine Plus Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Four hours post clofarabine infusion,Give cytarabine 1000 mg/m2 IV infusion over 2 hours.Patients will receive a maximum upto 4 cycles of study treatment.Next cycle will start approximately 4 weeks after Day 1 of previous cycle.
675174|NCT00334074|E1|Reported Event|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 intravenous infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 intravenous infusion 4 hours post clofarabine IVI.
675175|NCT00334061|B1|Baseline|Penumbra System|
675176|NCT00334061|P1|Participant Flow|Penumbra System|
675177|NCT00334061|O1|Outcome|Penumbra System|
675178|NCT00334061|O1|Outcome|Penumbra System|
675179|NCT00334061|O1|Outcome|Penumbra System|
675180|NCT00334061|O1|Outcome|Penumbra System|
675181|NCT00334061|O1|Outcome|Penumbra System|
675182|NCT00334061|O1|Outcome|Penumbra System|
675183|NCT00334061|E1|Reported Event|Penumbra System|
675184|NCT00333983|B4|Baseline|Total|Total of all reporting groups
675185|NCT00333983|B3|Baseline|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
675186|NCT00333983|B2|Baseline|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes.
675187|NCT00333983|B1|Baseline|Planar Robot|Robot-assisted planar reaching x 60 minutes.
675188|NCT00333983|P3|Participant Flow|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
675189|NCT00333983|P2|Participant Flow|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes
675190|NCT00333983|P1|Participant Flow|Planar Robot|Robot-assisted planar reaching x 60 minutes
675191|NCT00333983|O3|Outcome|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
675192|NCT00333983|O2|Outcome|Planar + Vertical|Planar + Vertical Robot Exercise x 60 minutes.
675193|NCT00333983|O1|Outcome|Planar Robot|Planar Robot Exercise x 60 minutes.
675194|NCT00333983|E3|Reported Event|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training.
675195|NCT00333983|E2|Reported Event|Planar + Vertical Robot|Planar + Vertical Robot Exercise Group
675196|NCT00333983|E1|Reported Event|Planar Robot|Planar Robot Exercise Group
675197|NCT00333970|B3|Baseline|Total|Total of all reporting groups
675198|NCT00333970|B2|Baseline|Arm 2|treatment as usual
675199|NCT00333970|B1|Baseline|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
675200|NCT00333970|P2|Participant Flow|Arm 2|treatment as usual
675201|NCT00333970|P1|Participant Flow|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
675202|NCT00333970|O2|Outcome|Arm 2|treatment as usual
675203|NCT00333970|O1|Outcome|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
675204|NCT00333970|E2|Reported Event|Arm 2|treatment as usual
675205|NCT00333970|E1|Reported Event|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
675206|NCT00333879|B1|Baseline|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
675207|NCT00333879|P1|Participant Flow|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
675208|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
675209|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
675210|NCT00333879|E1|Reported Event|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
675211|NCT00333866|B5|Baseline|Total|Total of all reporting groups
675212|NCT00333866|B4|Baseline|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675348|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675213|NCT00333866|B3|Baseline|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675214|NCT00333866|B2|Baseline|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675215|NCT00333866|B1|Baseline|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675216|NCT00333866|P4|Participant Flow|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675217|NCT00333866|P3|Participant Flow|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675218|NCT00333866|P2|Participant Flow|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675219|NCT00333866|P1|Participant Flow|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675220|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675221|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675222|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675223|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675224|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675225|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675226|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675227|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675228|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675229|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675230|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675231|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675232|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675233|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675234|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675235|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675236|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675237|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675238|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675239|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675240|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675349|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675241|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675242|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675243|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675244|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675245|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675246|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675247|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675248|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675249|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675250|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675251|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675252|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675253|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675254|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675255|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675256|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675257|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675258|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675259|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675260|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675261|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675262|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675263|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675264|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675265|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675266|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675267|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675268|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675350|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675269|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675270|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675271|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675272|NCT00333866|E4|Reported Event|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
675273|NCT00333866|E3|Reported Event|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
675274|NCT00333866|E2|Reported Event|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
675275|NCT00333866|E1|Reported Event|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
675276|NCT00333840|B3|Baseline|Total|Total of all reporting groups
675277|NCT00333840|B2|Baseline|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675278|NCT00333840|B1|Baseline|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675279|NCT00333840|P4|Participant Flow|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
675280|NCT00333840|P3|Participant Flow|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
675281|NCT00333840|P2|Participant Flow|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675282|NCT00333840|P1|Participant Flow|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675283|NCT00333840|O1|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
675284|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675285|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675351|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675286|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
675287|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 mu/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injection for 10 days every month in the second-line treatment period.
675288|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675289|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675290|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
675291|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
675292|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675293|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675294|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675295|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
675296|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675297|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675352|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675298|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675299|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675300|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675301|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
675302|NCT00333840|E4|Reported Event|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
675303|NCT00333840|E3|Reported Event|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
675304|NCT00333840|E2|Reported Event|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
675305|NCT00333840|E1|Reported Event|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
675306|NCT00333814|B4|Baseline|Total|Total of all reporting groups
675307|NCT00333814|B3|Baseline|Sham|Sham
675308|NCT00333814|B2|Baseline|Dexamethasone 700 µg|Dexamethasone 700 µg
675309|NCT00333814|B1|Baseline|Dexamethasone 350 µg|Dexamethasone 350 µg
675310|NCT00333814|P3|Participant Flow|Sham|Sham
675311|NCT00333814|P2|Participant Flow|Dexamethasone 700 µg|Dexamethasone 700 µg
675312|NCT00333814|P1|Participant Flow|Dexamethasone 350 µg|Dexamethasone 350 µg
675313|NCT00333814|O3|Outcome|Sham|Sham
675314|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
675315|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
675316|NCT00333814|O3|Outcome|Sham|Sham
675317|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
675318|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
675319|NCT00333814|O3|Outcome|Sham|Sham
675320|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
675321|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
675322|NCT00333814|E3|Reported Event|Sham|Sham
675323|NCT00333814|E2|Reported Event|Dexamethasone 700 µg|Dexamethasone 700 µg
675324|NCT00333814|E1|Reported Event|Dexamethasone 350 µg|Dexamethasone 350 µg
675325|NCT00333801|B3|Baseline|Total|Total of all reporting groups
675326|NCT00333801|B2|Baseline|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675327|NCT00333801|B1|Baseline|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675353|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675328|NCT00333801|P2|Participant Flow|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675329|NCT00333801|P1|Participant Flow|Vocational Rehabilitation Program (VRP)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
675330|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675331|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675332|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675333|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675334|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675335|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675336|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675337|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675338|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675339|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675340|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675341|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675342|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675343|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675344|NCT00333801|E2|Reported Event|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
675345|NCT00333801|E1|Reported Event|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
675346|NCT00333788|B1|Baseline|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675357|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675358|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675359|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675360|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675361|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675362|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675363|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675364|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675365|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675366|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675367|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675368|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675369|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675370|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675371|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675372|NCT00333788|E1|Reported Event|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
675373|NCT00333775|B4|Baseline|Total|Total of all reporting groups
675374|NCT00333775|B3|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675375|NCT00333775|B2|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675376|NCT00333775|B1|Baseline|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675377|NCT00333775|P3|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675378|NCT00333775|P2|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675379|NCT00333775|P1|Participant Flow|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675380|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675381|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675382|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675383|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675384|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675385|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675386|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675387|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675388|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675389|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675390|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675391|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675392|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675393|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675394|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675395|NCT00333775|E3|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675396|NCT00333775|E2|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675397|NCT00333775|E1|Reported Event|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
675398|NCT00333762|B1|Baseline|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
675399|NCT00333762|P1|Participant Flow|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
675400|NCT00333762|O1|Outcome|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
675401|NCT00333762|E1|Reported Event|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
675402|NCT00333710|B4|Baseline|Total|Total of all reporting groups
675403|NCT00333710|B3|Baseline|Control Condition/Treatment as Usual|"Control condition/treatment as usual.~No active treatment"
675404|NCT00333710|B2|Baseline|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
675405|NCT00333710|B1|Baseline|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
675406|NCT00333710|P3|Participant Flow|Control Condition/Treatment as Usual|Control condition/treatment as usual
675407|NCT00333710|P2|Participant Flow|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
675408|NCT00333710|P1|Participant Flow|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
675409|NCT00333710|O3|Outcome|Control Condition/Treatment as Usual|Control condition/treatment as usual
675410|NCT00333710|O2|Outcome|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
675411|NCT00333710|O1|Outcome|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
675412|NCT00333710|E3|Reported Event|Control Condition/Treatment as Usual|Control condition/treatment as usual
675413|NCT00333710|E2|Reported Event|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
675414|NCT00333710|E1|Reported Event|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
675415|NCT00333619|B3|Baseline|Total|Total of all reporting groups
675416|NCT00333619|B2|Baseline|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
675417|NCT00333619|B1|Baseline|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
675418|NCT00333619|P2|Participant Flow|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
675419|NCT00333619|P1|Participant Flow|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
675420|NCT00333619|O2|Outcome|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
675421|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
675422|NCT00333619|O2|Outcome|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
675423|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
675424|NCT00333619|E2|Reported Event|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
675425|NCT00333619|E1|Reported Event|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
675426|NCT00333437|B1|Baseline|Treatment|Study subjects receive standard mycophenolate dosing.
675427|NCT00333437|P1|Participant Flow|Single-group Study Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
675428|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
675429|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
675430|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
675431|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
675432|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
675433|NCT00333437|E1|Reported Event|Treatment|Study subjects receive standard mycophenolate dosing.
675434|NCT00333359|B3|Baseline|Total|Total of all reporting groups
675435|NCT00333359|B2|Baseline|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675436|NCT00333359|B1|Baseline|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675437|NCT00333359|P2|Participant Flow|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675438|NCT00333359|P1|Participant Flow|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675439|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675440|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675441|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675572|NCT00332709|P2|Participant Flow|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675442|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675443|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675444|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675445|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675446|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675447|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675448|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675449|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675450|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675451|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675452|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675453|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675454|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675455|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675456|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675457|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675458|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675459|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675460|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675461|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675462|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675463|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675464|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675465|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675466|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675467|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675573|NCT00332709|P1|Participant Flow|Letrozole|Letrozole 2.5 mg/day for 3 years
675468|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675469|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675470|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675471|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675472|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675473|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675474|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675475|NCT00333359|E3|Reported Event|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675476|NCT00333359|E2|Reported Event|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675477|NCT00333359|E1|Reported Event|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
675478|NCT00333229|B3|Baseline|Total|Total of all reporting groups
675479|NCT00333229|B2|Baseline|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675480|NCT00333229|B1|Baseline|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675481|NCT00333229|P2|Participant Flow|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675482|NCT00333229|P1|Participant Flow|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675483|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675484|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675485|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675486|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675487|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675488|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675489|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675490|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675491|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675492|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675493|NCT00333229|E2|Reported Event|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675494|NCT00333229|E1|Reported Event|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
675495|NCT00333138|B4|Baseline|Total|Total of all reporting groups
675496|NCT00333138|B3|Baseline|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675497|NCT00333138|B2|Baseline|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675498|NCT00333138|B1|Baseline|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675499|NCT00333138|P3|Participant Flow|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675500|NCT00333138|P2|Participant Flow|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675501|NCT00333138|P1|Participant Flow|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675502|NCT00333138|O2|Outcome|FTY720 5.0 mg/Day|Patients randomized to fingolimod 5.0 mg/d in the core study who received fingolimod 5.0 mg/d in the dose-blind period of the extension study. All patients received fingolimod 1.25 mg/d initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
675503|NCT00333138|O1|Outcome|FTY720 1.25 mg/Day|Patients randomized to fingolimod 1.25 mg/d in the core study who received fingolimod 1.25 mg/d in the dose-blind period of the extension study and initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
675504|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675505|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675506|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675507|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675508|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675509|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675510|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675511|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675512|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675513|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675514|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675515|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675516|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675574|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675575|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675517|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675518|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675519|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675520|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675521|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675522|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675523|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675524|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675525|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675526|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675527|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675528|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675529|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675530|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675531|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675532|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675533|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675534|NCT00333138|E3|Reported Event|Fingolimod (FTY720) 5.0 mg|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675535|NCT00333138|E2|Reported Event|Fingolimod (FTY720) 1.25 mg|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675576|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675536|NCT00333138|E1|Reported Event|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
675537|NCT00332839|B3|Baseline|Total|Total of all reporting groups
675538|NCT00332839|B2|Baseline|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675539|NCT00332839|B1|Baseline|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675540|NCT00332839|P2|Participant Flow|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675541|NCT00332839|P1|Participant Flow|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675542|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675543|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675544|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675545|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675546|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675547|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675548|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675549|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675550|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675551|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675552|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675553|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675554|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675555|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675556|NCT00332839|E2|Reported Event|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
675557|NCT00332839|E1|Reported Event|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
675558|NCT00332722|B3|Baseline|Total|Total of all reporting groups
675559|NCT00332722|B2|Baseline|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
675560|NCT00332722|B1|Baseline|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
675561|NCT00332722|P2|Participant Flow|Group 2 With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
675562|NCT00332722|P1|Participant Flow|Group 1 Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
675563|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
675564|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
675565|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
675566|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
675567|NCT00332722|E2|Reported Event|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
675568|NCT00332722|E1|Reported Event|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
675569|NCT00332709|B3|Baseline|Total|Total of all reporting groups
675570|NCT00332709|B2|Baseline|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675571|NCT00332709|B1|Baseline|Letrozole|Letrozole 2.5 mg/day for 3 years
675578|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675579|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675580|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675581|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675582|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675583|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675584|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675585|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675586|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675587|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675588|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675589|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675590|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675591|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
675592|NCT00332709|E2|Reported Event|Letrozole + Zolendronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
675593|NCT00332709|E1|Reported Event|Letrozole|Letrozole orally 2.5 mg/day for 3 years
675594|NCT00332696|B3|Baseline|Total|Total of all reporting groups
675595|NCT00332696|B2|Baseline|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675596|NCT00332696|B1|Baseline|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675597|NCT00332696|P2|Participant Flow|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675598|NCT00332696|P1|Participant Flow|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675599|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675600|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675601|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675602|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675603|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675604|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675605|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675682|NCT00332488|O2|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
675683|NCT00332488|O1|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
675684|NCT00332488|E3|Reported Event|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
675606|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675607|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675608|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675609|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675610|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675611|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675612|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675613|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675614|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675615|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675616|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675617|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675618|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675619|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675620|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675621|NCT00332696|E2|Reported Event|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675622|NCT00332696|E1|Reported Event|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
675623|NCT00332644|B7|Baseline|Total|Total of all reporting groups
675624|NCT00332644|B6|Baseline|Placebo Control|placebo control (no active medication) treatment
675625|NCT00332644|B5|Baseline|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
675626|NCT00332644|B4|Baseline|Bupropion|bupropion alone treatment
675627|NCT00332644|B3|Baseline|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
675628|NCT00332644|B2|Baseline|Nicotine Lozenge|nicotine lozenge alone treatment
675629|NCT00332644|B1|Baseline|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
675630|NCT00332644|P6|Participant Flow|Placebo Control|placebo control (no active medication) treatment
675631|NCT00332644|P5|Participant Flow|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
675632|NCT00332644|P4|Participant Flow|Bupropion|bupropion alone treatment
675633|NCT00332644|P3|Participant Flow|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
675634|NCT00332644|P2|Participant Flow|Nicotine Lozenge|nicotine lozenge alone treatment
675635|NCT00332644|P1|Participant Flow|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
675636|NCT00332644|O6|Outcome|Placebo Control|placebo control (no active medication) treatment
675637|NCT00332644|O5|Outcome|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
675638|NCT00332644|O4|Outcome|Bupropion|bupropion alone treatment
675639|NCT00332644|O3|Outcome|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
675640|NCT00332644|O2|Outcome|Nicotine Lozenge|nicotine lozenge alone treatment
675641|NCT00332644|O1|Outcome|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
675642|NCT00332644|E6|Reported Event|Placebo Control|placebo control (no active medication) treatment
675643|NCT00332644|E5|Reported Event|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
675644|NCT00332644|E4|Reported Event|Bupropion|bupropion alone treatment
675645|NCT00332644|E3|Reported Event|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
675646|NCT00332644|E2|Reported Event|Nicotine Lozenge|nicotine lozenge alone treatment
675647|NCT00332644|E1|Reported Event|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
675648|NCT00332605|B4|Baseline|Total|Total of all reporting groups
675649|NCT00332605|B3|Baseline|Placebo|
675650|NCT00332605|B2|Baseline|N-Acetyl Cysteine|600mg tablets taken by mouth daily
675651|NCT00332605|B1|Baseline|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
675652|NCT00332605|P3|Participant Flow|Placebo|
675653|NCT00332605|P2|Participant Flow|N-Acetyl Cysteine|600mg tablets taken by mouth daily
675654|NCT00332605|P1|Participant Flow|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
675655|NCT00332605|O3|Outcome|Placebo|Placebo capsules
675656|NCT00332605|O2|Outcome|N-Acetyl Cysteine|600mg tablets, daily
675657|NCT00332605|O1|Outcome|Naltrexone|Naltrexone tablets
675658|NCT00332605|E3|Reported Event|Placebo|
675659|NCT00332605|E2|Reported Event|N-Acetyl Cysteine|600mg tablets taken by mouth daily
675660|NCT00332605|E1|Reported Event|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
675661|NCT00332579|B3|Baseline|Total|Total of all reporting groups
675662|NCT00332579|B2|Baseline|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
675663|NCT00332579|B1|Baseline|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
675664|NCT00332579|P2|Participant Flow|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
675665|NCT00332579|P1|Participant Flow|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
675666|NCT00332579|O2|Outcome|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
675667|NCT00332579|O1|Outcome|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
675668|NCT00332579|E2|Reported Event|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
675669|NCT00332579|E1|Reported Event|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
675670|NCT00332488|B4|Baseline|Total|Total of all reporting groups
675671|NCT00332488|B3|Baseline|TI Inhalation Powder + Metformin|
675672|NCT00332488|B2|Baseline|Metformin & Secretagogues|
675673|NCT00332488|B1|Baseline|TI Inhalation Powder Alone|
675674|NCT00332488|P3|Participant Flow|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder administered prior to each meal (dose individualized for each subject) & Metformin (>= 1,000 mg/day or maximum tolerate dose)
675675|NCT00332488|P2|Participant Flow|Metformin & Secretagogues|Metformin (>= 1,000 mg/day or maximum tolerate dose) & Secretagogue (Sulfonylurea or meglitinide at >= half maximum manufacturer recommended dose or maximum tolerated dose)
675676|NCT00332488|P1|Participant Flow|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder administered prior to each meal without any other anti-diabetic treatment; dose individualized for each subject
675677|NCT00332488|O3|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
675678|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
675679|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
675685|NCT00332488|E2|Reported Event|Metformin & Secretagogues|Metformin & Secretagogues
675686|NCT00332488|E1|Reported Event|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
675687|NCT00332462|B1|Baseline|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
675688|NCT00332462|P1|Participant Flow|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
675689|NCT00332462|O2|Outcome|6 Months After Transplantation|
675690|NCT00332462|O1|Outcome|3 Months After Transplantation|
675691|NCT00332462|O1|Outcome|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
675692|NCT00332462|E2|Reported Event|Cyclosporine (Sandimmun® Optoral)|Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
675693|NCT00332462|E1|Reported Event|Cyclosporine (Sandimmun® i.v.)|Cyclosporine (Sandimmun®) intravenous (i.v) given 2 times daily as an infusion over a four hour period staring at a dose of 2 X 200 mg/day and continuing for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
675694|NCT00332332|B1|Baseline|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
675695|NCT00332332|P1|Participant Flow|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
675696|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
675697|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
675698|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
675699|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
675700|NCT00332332|E1|Reported Event|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
675701|NCT00332241|B3|Baseline|Total|Total of all reporting groups
675702|NCT00332241|B2|Baseline|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675703|NCT00332241|B1|Baseline|Placebo|oral placebo once daily (QD)
675704|NCT00332241|P2|Participant Flow|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675705|NCT00332241|P1|Participant Flow|Placebo|oral placebo once daily (QD)
675706|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675707|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675708|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675709|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675710|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675711|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675712|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675713|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675714|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675715|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675716|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675717|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675718|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675719|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675720|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
675721|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
675722|NCT00332241|E2|Reported Event|Placebo|
675723|NCT00332241|E1|Reported Event|Aripiprazole|
675724|NCT00332189|B1|Baseline|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
675725|NCT00332189|P1|Participant Flow|Total Patient Population|Phenoptin will be taken orally once daily as the number of tablets equivalent to that of the last prescribed dose of the previous study (PKU-004 NCT00225615 or PKU-006 NCT00272792). Subjects who participated in PKU-006 NCT00272792 will receive Phenoptin as the number of tablets equivalent to 20 mg/kg/day at enrollment. The Phenoptin dose may be adjusted up or down as needed at the discretion of the investigator in increments of approximately 5 mg/kg/day within a range of 5 mg/kg/day to 20 mg/kg/day to control blood Phe to levels consistent with local clinical site recommendations for blood Phe control.
675726|NCT00332189|O1|Outcome|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
675727|NCT00332189|O1|Outcome|Total Patient Population|The safety analysis population includes all subjects who received at least one dose of study drug during the study.
675728|NCT00332189|E1|Reported Event|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
675729|NCT00332163|B3|Baseline|Total|Total of all reporting groups
675730|NCT00332163|B2|Baseline|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675731|NCT00332163|B1|Baseline|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675732|NCT00332163|P2|Participant Flow|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675733|NCT00332163|P1|Participant Flow|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675734|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675735|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675736|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675737|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675738|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675739|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675740|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675741|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675742|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675743|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675744|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675745|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675746|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675810|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675747|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675748|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675749|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675750|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675751|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675752|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675753|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675754|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675755|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675756|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675757|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675758|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675759|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675760|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675761|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675762|NCT00332163|E2|Reported Event|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
675763|NCT00332163|E1|Reported Event|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
675764|NCT00331864|B3|Baseline|Total|Total of all reporting groups
675765|NCT00331864|B2|Baseline|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675840|NCT00331552|O1|Outcome|Heavily Pre-treated|1 or more regimens for advanced disease
675766|NCT00331864|B1|Baseline|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675767|NCT00331864|P2|Participant Flow|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675768|NCT00331864|P1|Participant Flow|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675769|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675770|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675771|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675772|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675773|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675774|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675775|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675776|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675777|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675778|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675779|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675780|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675811|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675909|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
675781|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675782|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675783|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675784|NCT00331864|E2|Reported Event|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675785|NCT00331864|E1|Reported Event|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
675786|NCT00331799|B1|Baseline|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
675787|NCT00331799|P1|Participant Flow|Open Label Treatment With Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg / day .
675788|NCT00331799|O1|Outcome|Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
675789|NCT00331799|E1|Reported Event|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
675790|NCT00331773|B3|Baseline|Total|Total of all reporting groups
675791|NCT00331773|B2|Baseline|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675792|NCT00331773|B1|Baseline|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675793|NCT00331773|P2|Participant Flow|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675794|NCT00331773|P1|Participant Flow|Conventional 3D-CRT|Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675795|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675796|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675797|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675798|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675799|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675800|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675801|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675802|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675803|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675804|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675805|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675806|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675807|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675808|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675809|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675812|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675813|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675814|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675815|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675816|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675817|NCT00331773|E2|Reported Event|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
675818|NCT00331773|E1|Reported Event|Conventional 3D-CRT|CConventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
675819|NCT00331760|B3|Baseline|Total|Total of all reporting groups
675820|NCT00331760|B2|Baseline|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
675821|NCT00331760|B1|Baseline|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
675822|NCT00331760|P2|Participant Flow|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
675823|NCT00331760|P1|Participant Flow|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
675824|NCT00331760|O2|Outcome|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
675825|NCT00331760|O1|Outcome|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
675826|NCT00331760|E2|Reported Event|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
675827|NCT00331760|E1|Reported Event|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
675828|NCT00331682|B1|Baseline|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
675829|NCT00331682|P1|Participant Flow|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~alvocidib: Given IV~docetaxel: Given IV"
675830|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
675831|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
675832|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
675833|NCT00331682|E1|Reported Event|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
675834|NCT00331552|B3|Baseline|Total|Total of all reporting groups
675835|NCT00331552|B2|Baseline|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675836|NCT00331552|B1|Baseline|Phase I: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675837|NCT00331552|P2|Participant Flow|Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675838|NCT00331552|P1|Participant Flow|Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675839|NCT00331552|O2|Outcome|Less Heavily Pre-treated|no regimens for advanced disease
675841|NCT00331552|O1|Outcome|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675842|NCT00331552|O1|Outcome|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675843|NCT00331552|O1|Outcome|Phase II: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675844|NCT00331552|O2|Outcome|Doxil 35 mg/m^2|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675845|NCT00331552|O1|Outcome|Doxil 30 mg/m^2|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675846|NCT00331552|O1|Outcome|Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675847|NCT00331552|O1|Outcome|Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675848|NCT00331552|O1|Outcome|Phase I: Cyclophosphamide, Doxil, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675849|NCT00331552|E2|Reported Event|Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675850|NCT00331552|E1|Reported Event|Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab|"Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.~pegylated liposomal doxorubicin hydrochloride: Given IV~cyclophosphamide: Given orally~trastuzumab: Given IV"
675851|NCT00331422|B1|Baseline|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675852|NCT00331422|P1|Participant Flow|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675853|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675854|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675855|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675856|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675910|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
675857|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675858|NCT00331422|O1|Outcome|Evaluable Patients (Received 4 Cycles of Therapy and Surgery)|Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
675859|NCT00331422|E1|Reported Event|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
675860|NCT00331409|B1|Baseline|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675861|NCT00331409|P1|Participant Flow|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675862|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675863|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675864|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675865|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675866|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675867|NCT00331409|E1|Reported Event|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
675868|NCT00331344|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive mitoxantrone hydrochloride IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675869|NCT00331344|P9|Participant Flow|Phase II|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675870|NCT00331344|P8|Participant Flow|Phase I Group VIa|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675871|NCT00331344|P7|Participant Flow|Phase I Group Va|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675872|NCT00331344|P6|Participant Flow|Phase I Group VI|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675873|NCT00331344|P5|Participant Flow|Phase I Group V|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675874|NCT00331344|P4|Participant Flow|Phase I Group IV|"Patients receive mitoxantrone hydrochloride 10mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675875|NCT00331344|P3|Participant Flow|Phase I Group III|"Patients receive mitoxantrone hydrochloride 10mg/m2 IV over 30 minutes and ixabepilone 25mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675876|NCT00331344|P2|Participant Flow|Phase I Group II|"Patients receive mitoxantrone hydrochloride 8mg/m2 IV over 30 minutes and ixabepilone 25mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675877|NCT00331344|P1|Participant Flow|Phase I Group I|"Patients receive mitoxantrone hydrochloride 8mg/m2 IV over 30 minutes and ixabepilone 20mg/m2 IV over 3 hours on day 1 and oral prednisone 5mg twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675878|NCT00331344|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675879|NCT00331344|O8|Outcome|Phase I Group VIa|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675911|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
675880|NCT00331344|O7|Outcome|Phase I Group Va|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675881|NCT00331344|O6|Outcome|Phase I Group VI|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675882|NCT00331344|O5|Outcome|Phase I Group V|"Patients receive mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675883|NCT00331344|O4|Outcome|Phase I Group IV|"Patients receive mitoxantrone hydrochloride 10 mg/m2 IV over 30 minutes and ixabepilone 30mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675884|NCT00331344|O3|Outcome|Phase I Group III|"Patients receive mitoxantrone hydrochloride 10 mg/m2 IV over 30 minutes and ixabepilone 25 mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675885|NCT00331344|O2|Outcome|Phase Group II|"Patients receive mitoxantrone hydrochloride 8 mg/m2 IV over 30 minutes and ixabepilone 25mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675886|NCT00331344|O1|Outcome|Phase I Group I|"Patients receive mitoxantrone hydrochloride 8 mg/m2 IV over 30 minutes and ixabepilone 20mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~prednisone: Given orally"
675887|NCT00331344|O1|Outcome|Phase I Treatment (Groups I-VIa)|"Patients receive mitoxantrone hydrochloride 8-12mg/m2 IV over 30 minutes and ixabepilone 20-35mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Patients in groups Va and VIa also received pegfilgrastim 6mg SC on day 2. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675888|NCT00331344|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675889|NCT00331344|E1|Reported Event|Phase I and Phase II (Cumulative)|"Patients in the Phase I period receive mitoxantrone hydrochloride 8-12mg/m2 IV over 30 minutes and ixabepilone 20-35mg/m2 IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Patients in groups Va and VIa also received pegfilgrastim 6mg SC on day 2. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~Patients in Phase II receive mitoxantrone hydrochloride 12mg/m2 IV over 30 minutes and ixabepilone 35mg/m2 IV over 3 hours on day 1 and pegfilgrastim 6mg SC on day 2 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.~Adverse Events below are reported cumulatively for the entire study.~mitoxantrone hydrochloride: Given IV~ixabepilone: Given IV~pegfilgrastim: Given SC~prednisone: Given orally"
675890|NCT00331006|B1|Baseline|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675891|NCT00331006|P1|Participant Flow|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675892|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675893|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675894|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675895|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675896|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675897|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675898|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675899|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675900|NCT00331006|E1|Reported Event|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
675901|NCT00330967|B3|Baseline|Total|Total of all reporting groups
675902|NCT00330967|B2|Baseline|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
675903|NCT00330967|B1|Baseline|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
675904|NCT00330967|P2|Participant Flow|Group 2|"Femoral arterial Intralipid infusion subjects~20% Intralipid: lipid infusion"
675905|NCT00330967|P1|Participant Flow|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
675906|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
675907|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
675908|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
675912|NCT00330967|O1|Outcome|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
675913|NCT00330967|E2|Reported Event|Group 2|"Femoral Intralipid infusion group~20% Intralipid: lipid infusion"
675914|NCT00330967|E1|Reported Event|Group 1|"Systemic Intralipid infusion group~20% Intralipid: lipid infusion"
675915|NCT00330928|B1|Baseline|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
675916|NCT00330928|P1|Participant Flow|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
675917|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
675918|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
675919|NCT00330928|E1|Reported Event|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
675920|NCT00330915|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
675921|NCT00330915|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
675922|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
675923|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
675924|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
675925|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
675926|NCT00330915|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
675927|NCT00330876|B1|Baseline|Safety Population|Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily
675928|NCT00330876|P2|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
675929|NCT00330876|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
675930|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
675931|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
675932|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
675933|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
675934|NCT00330876|E2|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
675935|NCT00330876|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
675936|NCT00330759|B3|Baseline|Total|Total of all reporting groups
675937|NCT00330759|B2|Baseline|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
675938|NCT00330759|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
675939|NCT00330759|P2|Participant Flow|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
675940|NCT00330759|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
675941|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
675942|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
675943|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
675944|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
675945|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
675946|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
675947|NCT00330759|E2|Reported Event|Denosumab 120 mg Q4W|
675948|NCT00330759|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
675949|NCT00330733|B3|Baseline|Total|Total of all reporting groups
675950|NCT00330733|B2|Baseline|Arm 2|"Salsalate~Salsalate: Salsalate therapy, double-masked"
675951|NCT00330733|B1|Baseline|Arm 1|"Matching placebo~Placebo: Matching placebo"
675952|NCT00330733|P2|Participant Flow|Arm 2|"Salsalate~Salsalate: Salsalate therapy"
675953|NCT00330733|P1|Participant Flow|Arm 1|"Matching placebo~Placebo: Matching placebo~Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication"
675954|NCT00330733|O2|Outcome|Arm 2|"Salsalate~Salsalate: Salsalate therapy"
675955|NCT00330733|O1|Outcome|Arm 1|"Matching placebo~Placebo: Matching placebo"
675956|NCT00330733|E2|Reported Event|Arm 2|"Salsalate~Salsalate: Salsalate therapy The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
675957|NCT00330733|E1|Reported Event|Arm 1|"Matching placebo~Placebo: Matching placebo The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
675958|NCT00330681|B3|Baseline|Total|Total of all reporting groups
675959|NCT00330681|B2|Baseline|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675960|NCT00330681|B1|Baseline|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675961|NCT00330681|P2|Participant Flow|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675962|NCT00330681|P1|Participant Flow|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675963|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675964|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675965|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675966|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675967|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675968|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675969|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675970|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675971|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675972|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675973|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675974|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675975|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675976|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675977|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675978|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675979|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675980|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675981|NCT00330681|E2|Reported Event|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
675982|NCT00330681|E1|Reported Event|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
675983|NCT00330668|B1|Baseline|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
675984|NCT00330668|P1|Participant Flow|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
675985|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
675986|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
675987|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
675988|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
675989|NCT00330668|E1|Reported Event|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
675990|NCT00330616|B1|Baseline|Bupropion SR|
675991|NCT00330616|P1|Participant Flow|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
675992|NCT00330616|O1|Outcome|Bupropion SR|
675993|NCT00330616|O1|Outcome|Bupropion SR|
675994|NCT00330616|O1|Outcome|Bupropion SR|
675995|NCT00330616|O1|Outcome|Bupropion SR|
675996|NCT00330616|O1|Outcome|Bupropion SR|
675997|NCT00330616|O1|Outcome|Bupropion SR|
675998|NCT00330616|O1|Outcome|Bupropion SR|
675999|NCT00330616|O1|Outcome|Bupropion SR|
676000|NCT00330616|O1|Outcome|Bupropion SR|
676001|NCT00330616|O1|Outcome|Bupropion SR|
676002|NCT00330616|O1|Outcome|Bupropion SR|
676003|NCT00330616|O1|Outcome|Bupropion SR|
676004|NCT00330616|O1|Outcome|Bupropion SR|
676005|NCT00330616|O1|Outcome|Bupropion SR|
676006|NCT00330616|O1|Outcome|Bupropion SR|
676007|NCT00330616|O1|Outcome|Bupropion SR|
676008|NCT00330616|E1|Reported Event|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
676009|NCT00330564|B1|Baseline|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
676010|NCT00330564|P1|Participant Flow|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
676011|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
676012|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
676013|NCT00330564|E1|Reported Event|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
676014|NCT00330460|B3|Baseline|Total|Total of all reporting groups
676015|NCT00330460|B2|Baseline|Denosumab 60 mg Q6M|
676016|NCT00330460|B1|Baseline|Alendronate 70 mg QW|
676017|NCT00330460|P2|Participant Flow|Denosumab 60 mg Q6M|
676018|NCT00330460|P1|Participant Flow|Alendronate 70 mg QW|
676019|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
676020|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
676021|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
676022|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
676023|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
676031|NCT00330421|B1|Baseline|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
676032|NCT00330421|P2|Participant Flow|Group I (Sarcomas of Extremity)|Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
676033|NCT00330421|P1|Participant Flow|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
676034|NCT00330421|O1|Outcome|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
676035|NCT00330421|E1|Reported Event|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
676036|NCT00330382|B3|Baseline|Total|Total of all reporting groups
676037|NCT00330382|B2|Baseline|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676038|NCT00330382|B1|Baseline|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676039|NCT00330382|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676040|NCT00330382|P1|Participant Flow|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676041|NCT00330382|O1|Outcome|Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups|"Patients receive oral Bowman-Birk inhibitor concentrate or Placebo twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally Placebo: Given orally laboratory biomarker analysis: Correlative studies"
676042|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676043|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676044|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676045|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676046|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676047|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676048|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676049|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676050|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676051|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676052|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676053|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676280|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676054|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676055|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676056|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676057|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676058|NCT00330382|E2|Reported Event|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
676059|NCT00330382|E1|Reported Event|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
676060|NCT00330343|B1|Baseline|Group 1|
676061|NCT00330343|P1|Participant Flow|Naloxone|
676062|NCT00330343|O1|Outcome|Naloxone|
676063|NCT00330343|E1|Reported Event|Group 1|
676064|NCT00330174|B3|Baseline|Total|Total of all reporting groups
676065|NCT00330174|B2|Baseline|Placebo|Matching placebo tablets
676066|NCT00330174|B1|Baseline|Acamprosate|Acamprosate tablets
676067|NCT00330174|P2|Participant Flow|Placebo|Matching placebo tablets
676068|NCT00330174|P1|Participant Flow|Acamprosate|Acamprosate tablets
676069|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
676070|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
676071|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
676072|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
676073|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
676074|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
676075|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
676076|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
676077|NCT00330174|E2|Reported Event|Placebo|Matching placebo tablets
676078|NCT00330174|E1|Reported Event|Acamprosate|Acamprosate tablets
676079|NCT00330161|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676080|NCT00330161|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676081|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676082|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676083|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676084|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676085|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
677235|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
676086|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676087|NCT00330161|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
676088|NCT00329901|B4|Baseline|Total|Total of all reporting groups
676089|NCT00329901|B3|Baseline|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676090|NCT00329901|B2|Baseline|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
676091|NCT00329901|B1|Baseline|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676092|NCT00329901|P3|Participant Flow|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676093|NCT00329901|P2|Participant Flow|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
676094|NCT00329901|P1|Participant Flow|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676095|NCT00329901|O3|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676096|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
676097|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676098|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
676099|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676100|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676101|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676102|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676103|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676104|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676105|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676106|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676107|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676108|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676109|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676110|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
676111|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676112|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
676113|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676114|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
676115|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676116|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
676117|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
676118|NCT00329901|E3|Reported Event|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
676119|NCT00329901|E2|Reported Event|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
676120|NCT00329901|E1|Reported Event|Tdap + MenACWY-CRM|Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
676121|NCT00329849|B3|Baseline|Total|Total of all reporting groups
676122|NCT00329849|B2|Baseline|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676123|NCT00329849|B1|Baseline|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676124|NCT00329849|P2|Participant Flow|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676125|NCT00329849|P1|Participant Flow|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676126|NCT00329849|O4|Outcome|MenACWY-PS_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676127|NCT00329849|O3|Outcome|MenACWY-CRM_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676128|NCT00329849|O2|Outcome|MenACWY-PS_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676129|NCT00329849|O1|Outcome|MenACWY-CRM_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676130|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676131|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676132|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676133|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676134|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676135|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676136|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676137|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676138|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676139|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676140|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676141|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676142|NCT00329849|E2|Reported Event|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
676143|NCT00329849|E1|Reported Event|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
676144|NCT00329836|B1|Baseline|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
676145|NCT00329836|P1|Participant Flow|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
676146|NCT00329836|O1|Outcome|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
676147|NCT00329836|E1|Reported Event|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
676148|NCT00329797|B3|Baseline|Total|Total of all reporting groups
676149|NCT00329797|B2|Baseline|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676150|NCT00329797|B1|Baseline|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676151|NCT00329797|P2|Participant Flow|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676152|NCT00329797|P1|Participant Flow|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and luteinizing hormone-releasing hormone (LHRH) therapy.
676153|NCT00329797|O2|Outcome|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676154|NCT00329797|O1|Outcome|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676155|NCT00329797|O2|Outcome|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676156|NCT00329797|O1|Outcome|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676157|NCT00329797|O2|Outcome|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676158|NCT00329797|O1|Outcome|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676159|NCT00329797|O2|Outcome|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676160|NCT00329797|O1|Outcome|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676161|NCT00329797|E2|Reported Event|Control|Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676162|NCT00329797|E1|Reported Event|Zoledronic Acid|Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
676163|NCT00329784|B5|Baseline|Total|Total of all reporting groups
676164|NCT00329784|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676165|NCT00329784|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676347|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676166|NCT00329784|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676167|NCT00329784|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676168|NCT00329784|P4|Participant Flow|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676169|NCT00329784|P3|Participant Flow|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676170|NCT00329784|P2|Participant Flow|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676171|NCT00329784|P1|Participant Flow|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676172|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676173|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
676174|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676175|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
676176|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676177|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
676178|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676179|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
676180|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676181|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
676182|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676183|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
676184|NCT00329784|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676185|NCT00329784|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676186|NCT00329784|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676187|NCT00329784|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676188|NCT00329784|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676189|NCT00329784|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676190|NCT00329784|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
676191|NCT00329784|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
676192|NCT00329771|B1|Baseline|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
676193|NCT00329771|P1|Participant Flow|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
676194|NCT00329771|O1|Outcome|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
676195|NCT00329771|E1|Reported Event|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
676196|NCT00329745|B3|Baseline|Total|Total of all reporting groups
676197|NCT00329745|B2|Baseline|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
676198|NCT00329745|B1|Baseline|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
676199|NCT00329745|P2|Participant Flow|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
676200|NCT00329745|P1|Participant Flow|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
676201|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
676202|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
676203|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
676204|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
676205|NCT00329745|E2|Reported Event|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
676206|NCT00329745|E1|Reported Event|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
676207|NCT00329732|B3|Baseline|Total|Total of all reporting groups
676208|NCT00329732|B2|Baseline|Saline (Placebo)|
676209|NCT00329732|B1|Baseline|Lidocaine/Bupivicaine|
676210|NCT00329732|P2|Participant Flow|Saline (Placebo)|
676211|NCT00329732|P1|Participant Flow|Lidocaine/Bupivicaine|
676212|NCT00329732|O1|Outcome|Lidocaine/Bupivicaine|
676213|NCT00329732|E2|Reported Event|Saline (Placebo)|
676214|NCT00329732|E1|Reported Event|Lidocaine/Bupivicaine|
676215|NCT00329719|B5|Baseline|Total|Total of all reporting groups
676216|NCT00329719|B4|Baseline|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676217|NCT00329719|B3|Baseline|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
676218|NCT00329719|B2|Baseline|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676219|NCT00329719|B1|Baseline|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676220|NCT00329719|P4|Participant Flow|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676221|NCT00329719|P3|Participant Flow|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
676222|NCT00329719|P2|Participant Flow|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676281|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676223|NCT00329719|P1|Participant Flow|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676224|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676225|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
676226|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676227|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676228|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676229|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
676230|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676231|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676232|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676233|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
676234|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676235|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676236|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676237|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
676238|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676239|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676240|NCT00329719|E4|Reported Event|Phase II, Arm D|"Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676282|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676978|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676241|NCT00329719|E3|Reported Event|Phase II, Arm C|"Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
676242|NCT00329719|E2|Reported Event|Phase II, Arm B|"Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676243|NCT00329719|E1|Reported Event|Phase I, Arm A|"Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
676244|NCT00329641|B1|Baseline|Sorafenib, Carboplatin, Paclitaxel|
676245|NCT00329641|P1|Participant Flow|Sorafenib, Carboplatin, Paclitaxel|Standard carboplatin and paclitaxel doses with the addition of sorafenib (800 mg daily)
676246|NCT00329641|O1|Outcome|Intervention|Sorafenib, Carboplatin, Paclitaxel
676247|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
676248|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
676249|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
676250|NCT00329641|E1|Reported Event|Intervention|Sorafenib, Carboplatin, Paclitaxel
676251|NCT00329602|B3|Baseline|Total|Total of all reporting groups
676252|NCT00329602|B2|Baseline|Double-Blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676253|NCT00329602|B1|Baseline|Double-Blind Placebo|Matching placebo tablets
676254|NCT00329602|P3|Participant Flow|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676255|NCT00329602|P2|Participant Flow|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676256|NCT00329602|P1|Participant Flow|Double-blind Placebo|Matching placebo tablets
676257|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not excluded from the IRLS post-hoc analysis
676258|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not excluded from the IRLS post-hoc analysis
676259|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not in the center groups with the highest or lowest treatment effects
676260|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not in the center groups with the highest or lowest treatment effects
676261|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676262|NCT00329602|O4|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676263|NCT00329602|O3|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676264|NCT00329602|O2|Outcome|Double-blind Placebo|Matching placebo tablets
676265|NCT00329602|O1|Outcome|Overall Study|
676266|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676267|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676268|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676269|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676270|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676271|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676272|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676273|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676274|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676275|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676276|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676277|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676278|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676279|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676283|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676284|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676285|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676286|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
676287|NCT00329602|E3|Reported Event|Open-Label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676288|NCT00329602|E2|Reported Event|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
676289|NCT00329602|E1|Reported Event|Double-blind Placebo|Matching placebo tablets
676290|NCT00329550|B4|Baseline|Total|Total of all reporting groups
676291|NCT00329550|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676292|NCT00329550|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676293|NCT00329550|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676294|NCT00329550|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676295|NCT00329550|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676296|NCT00329550|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676297|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676298|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676299|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676300|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676301|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676302|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676303|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676304|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676305|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676306|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676307|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676308|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676309|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676310|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676311|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676312|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676313|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676314|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676315|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676979|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676316|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676317|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676318|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676319|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676320|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676321|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676322|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676323|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676324|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676325|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676326|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676327|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676328|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676329|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676330|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676331|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676332|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676333|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676334|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676335|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676336|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676337|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676338|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676339|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676340|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676341|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676342|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676343|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676344|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676345|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676346|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676980|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676348|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676349|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676350|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676351|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676352|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676353|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676354|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676355|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676356|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676357|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676358|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676359|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676360|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676361|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676362|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676363|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676364|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676365|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676366|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676367|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676368|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676369|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676370|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676371|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676372|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676373|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676374|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676375|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676376|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676377|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676378|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676981|NCT00329238|E4|Reported Event|Post Warfarin|
676982|NCT00329238|E3|Reported Event|Post Dabigatran|
676379|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676380|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676381|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676382|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676383|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676384|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676385|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676386|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676387|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676388|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676389|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676390|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676391|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676392|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676393|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676394|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676395|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676396|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676397|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676398|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676399|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676400|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676401|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676402|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676403|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676404|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676405|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676406|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676407|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676408|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676409|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676983|NCT00329238|E2|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676410|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676411|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676412|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676413|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676414|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676415|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676416|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676417|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676418|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676419|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676420|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676421|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676422|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676423|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676424|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676425|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676426|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676427|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676428|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676429|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676430|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676431|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676432|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676433|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676434|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676435|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676436|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676437|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676438|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676439|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676440|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676984|NCT00329238|E1|Reported Event|Dabigatran|150 mg twice daily, total daily dose 300 mg
676441|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676442|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676443|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676444|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676445|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676446|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676447|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676448|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676449|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676450|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676451|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676452|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676453|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676454|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676455|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676456|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676457|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676458|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676459|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676460|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676461|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676462|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676463|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676464|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676465|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676466|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676467|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676468|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676469|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676470|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676471|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677025|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677026|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
676472|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676473|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676474|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676475|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676476|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676477|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676478|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676479|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676480|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676481|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676482|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676483|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676484|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676485|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676486|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676487|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676488|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676489|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676490|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676491|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676492|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676493|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676494|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676495|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676496|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676497|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676498|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676499|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676500|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676501|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676502|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677027|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677028|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
676503|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676504|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676505|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676506|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676507|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676508|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676509|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676510|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676511|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676512|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676513|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676514|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676515|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676516|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676517|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676518|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676519|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676520|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676521|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676522|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676523|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676524|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676525|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676526|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676527|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676528|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676529|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676530|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676531|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676532|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676533|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677029|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677030|NCT00329030|E2|Reported Event|R-BEAM|Rituxan/BEAM
676534|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676535|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676536|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676537|NCT00329550|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (NCT00291668) and this extension study for all 40 subjects who entered this extension study, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
676538|NCT00329550|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 40 subjects who entered this extension study.
676539|NCT00329550|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676540|NCT00329550|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676541|NCT00329550|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676542|NCT00329524|B1|Baseline|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
676543|NCT00329524|P1|Participant Flow|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
676544|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
676545|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
676546|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
676547|NCT00329524|E1|Reported Event|Active Versus Sham Treatment|"Subjects randomly assigned to active and sham TMS separated by one week interval.~Repetitive Transcranial Magnetic Stimulation (rTMS): TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectiv"
676548|NCT00329433|B3|Baseline|Total|Total of all reporting groups
676549|NCT00329433|B2|Baseline|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
676550|NCT00329433|B1|Baseline|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
676551|NCT00329433|P2|Participant Flow|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
676552|NCT00329433|P1|Participant Flow|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
676553|NCT00329433|O2|Outcome|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
676554|NCT00329433|O1|Outcome|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
676555|NCT00329433|E2|Reported Event|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
676556|NCT00329433|E1|Reported Event|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
676557|NCT00329420|B4|Baseline|Total|Total of all reporting groups
676558|NCT00329420|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677031|NCT00329030|E1|Reported Event|B-BEAM|Bexxar/BEAM
676559|NCT00329420|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676560|NCT00329420|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676561|NCT00329420|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676562|NCT00329420|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676563|NCT00329420|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676564|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676565|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676566|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676567|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676568|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676569|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676570|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676571|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676572|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676573|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676574|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676575|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676576|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676577|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676578|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676579|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676580|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676581|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676582|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676583|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676584|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676585|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676586|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677032|NCT00328926|B4|Baseline|Total|Total of all reporting groups
679771|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
676587|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676588|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676589|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676590|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676591|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676592|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676593|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676594|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676595|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676596|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676597|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676598|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676599|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676600|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676601|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676602|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676603|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676604|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676605|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676606|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676607|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676608|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676609|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676610|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676611|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676612|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676613|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676614|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676615|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676616|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676617|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676618|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676619|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676620|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676621|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676622|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676623|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676624|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676625|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676626|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676627|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676628|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676629|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676630|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676631|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676632|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676633|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676634|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676635|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676636|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676637|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676638|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676639|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676640|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676641|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676642|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676643|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676644|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676645|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676646|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676647|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676648|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676649|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676650|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676651|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676652|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676653|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676654|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676655|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676656|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676657|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676658|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676659|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676660|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676661|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676662|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676663|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676664|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676665|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676666|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676667|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676668|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676669|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676670|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676671|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676672|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677076|NCT00328627|B13|Baseline|Total|Total of all reporting groups
677505|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
676673|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676674|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676675|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676676|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676677|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676678|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676679|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676680|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676681|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676682|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676683|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676684|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676685|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676686|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676687|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676688|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676689|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676690|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676691|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676692|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676693|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676694|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676695|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676696|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676697|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676698|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676699|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676700|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676701|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676702|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676703|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676704|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676705|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676706|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676707|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676708|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676709|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676710|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676711|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676712|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676713|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676714|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676715|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676716|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676717|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676718|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676719|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676720|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676721|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676722|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676723|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676724|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676725|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676726|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676727|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676728|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676729|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677077|NCT00328627|B12|Baseline|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
676730|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676731|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676732|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676733|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676734|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676735|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676736|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676737|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676738|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676739|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676740|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676741|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676742|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676743|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676744|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676745|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676746|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676747|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676748|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676749|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676750|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676751|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676752|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676753|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676754|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676755|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676756|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676757|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676758|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676759|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676760|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676761|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676762|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676763|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676764|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676765|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676766|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676767|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676768|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676769|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676770|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676771|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676772|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676773|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676774|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676775|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676776|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676777|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676778|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676779|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676780|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676781|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676782|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676783|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676784|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676785|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676786|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677078|NCT00328627|B11|Baseline|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
676787|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676788|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676789|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676790|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676791|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676792|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676793|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676794|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676795|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676796|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676797|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676798|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676799|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676800|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676801|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676802|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676803|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676804|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676805|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676806|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676807|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676808|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676809|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676810|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676811|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676812|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676813|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676814|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676815|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676816|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676817|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676818|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676819|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676820|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676821|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676822|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676823|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676824|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676825|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676826|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676827|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676828|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676829|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676830|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676831|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676832|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676833|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676834|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676835|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676836|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676837|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676838|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676839|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676840|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676841|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676842|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676843|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677079|NCT00328627|B10|Baseline|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
676844|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676845|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676846|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676847|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676848|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676849|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676850|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676851|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676852|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676853|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676854|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676855|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676856|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676857|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676858|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676859|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676860|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676861|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676862|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676863|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676864|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676865|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676866|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676867|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676868|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676869|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676870|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676871|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676872|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676873|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676874|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676875|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676876|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676877|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676878|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676879|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676880|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676881|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676882|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676883|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676884|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676885|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676886|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676887|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676888|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676889|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676890|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676891|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676892|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676893|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676894|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676895|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676896|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676897|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676898|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676899|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676900|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
677080|NCT00328627|B9|Baseline|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
676901|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676902|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676903|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676904|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676905|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676906|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676907|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676908|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676909|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676910|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676911|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676912|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676913|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676914|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676915|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676916|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676917|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676918|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676919|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676920|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676921|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676922|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676923|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676924|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676925|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676926|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676927|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676928|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676929|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676930|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676931|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676932|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676933|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676934|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676935|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676936|NCT00329420|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (N00291668) and this extension study for all 46 subjects who entered this extension study C87048, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
676937|NCT00329420|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study.
676938|NCT00329420|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676939|NCT00329420|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676940|NCT00329420|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
676941|NCT00329407|B1|Baseline|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
676942|NCT00329407|P1|Participant Flow|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
676943|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
676944|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
676945|NCT00329407|E1|Reported Event|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
676946|NCT00329238|B3|Baseline|Total|Total of all reporting groups
676947|NCT00329238|B2|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676948|NCT00329238|B1|Baseline|Dabigatran|150 mg twice daily, total daily dose 300 mg
676949|NCT00329238|P2|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676950|NCT00329238|P1|Participant Flow|Dabigatran|150 mg twice daily, total daily dose 300 mg
676951|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676952|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676953|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676954|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676955|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676956|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676957|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676958|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676959|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676960|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676961|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676962|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676963|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676964|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676965|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676966|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676967|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676968|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676969|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676970|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676971|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676972|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676973|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676974|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676975|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676976|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
676977|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
676985|NCT00329160|B1|Baseline|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
676986|NCT00329160|P1|Participant Flow|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
676987|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
676988|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
676989|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
676990|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
676991|NCT00329160|E1|Reported Event|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
676992|NCT00329108|B3|Baseline|Total|Total of all reporting groups
676993|NCT00329108|B2|Baseline|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
676994|NCT00329108|B1|Baseline|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
676995|NCT00329108|P2|Participant Flow|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
676996|NCT00329108|P1|Participant Flow|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
676997|NCT00329108|O2|Outcome|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
676998|NCT00329108|O1|Outcome|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
676999|NCT00329108|E2|Reported Event|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
677000|NCT00329108|E1|Reported Event|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
677001|NCT00329030|B3|Baseline|Total|Total of all reporting groups
677002|NCT00329030|B2|Baseline|R-BEAM|Rituxan/BEAM
677003|NCT00329030|B1|Baseline|B-BEAM|Bexxar/BEAM
677004|NCT00329030|P2|Participant Flow|R-BEAM|Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
677005|NCT00329030|P1|Participant Flow|B-BEAM|Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
677006|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677007|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677008|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677009|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677010|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677011|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677012|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677013|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677014|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677015|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677016|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677017|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677018|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677019|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677020|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677021|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677022|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677023|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
677024|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
677033|NCT00328926|B3|Baseline|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677034|NCT00328926|B2|Baseline|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677035|NCT00328926|B1|Baseline|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677036|NCT00328926|P3|Participant Flow|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677037|NCT00328926|P2|Participant Flow|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677038|NCT00328926|P1|Participant Flow|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677039|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677040|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677041|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
679772|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
677042|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677043|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677044|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677045|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677046|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677047|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677048|NCT00328926|E3|Reported Event|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677049|NCT00328926|E2|Reported Event|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677050|NCT00328926|E1|Reported Event|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
677051|NCT00328861|B3|Baseline|Total|Total of all reporting groups
677052|NCT00328861|B2|Baseline|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677053|NCT00328861|B1|Baseline|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677054|NCT00328861|P2|Participant Flow|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677055|NCT00328861|P1|Participant Flow|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677056|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677057|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677058|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677059|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677060|NCT00328861|E2|Reported Event|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677061|NCT00328861|E1|Reported Event|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
677062|NCT00328783|B1|Baseline|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
677063|NCT00328783|P1|Participant Flow|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
677064|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
677065|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
677066|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.~Radiation Therapy"
677067|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
677068|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
677069|NCT00328783|E1|Reported Event|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
677070|NCT00328770|B1|Baseline|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
677071|NCT00328770|P1|Participant Flow|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
677072|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
677073|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
677074|NCT00328770|O1|Outcome|Patient Survival|1 and 4 year patient survival
677075|NCT00328770|E1|Reported Event|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
677081|NCT00328627|B8|Baseline|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677082|NCT00328627|B7|Baseline|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677083|NCT00328627|B6|Baseline|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677084|NCT00328627|B5|Baseline|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677085|NCT00328627|B4|Baseline|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677086|NCT00328627|B3|Baseline|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677087|NCT00328627|B2|Baseline|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677088|NCT00328627|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677089|NCT00328627|P12|Participant Flow|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677090|NCT00328627|P11|Participant Flow|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677091|NCT00328627|P10|Participant Flow|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677092|NCT00328627|P9|Participant Flow|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677093|NCT00328627|P8|Participant Flow|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677094|NCT00328627|P7|Participant Flow|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677095|NCT00328627|P6|Participant Flow|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677096|NCT00328627|P5|Participant Flow|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677097|NCT00328627|P4|Participant Flow|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677098|NCT00328627|P3|Participant Flow|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677099|NCT00328627|P2|Participant Flow|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677100|NCT00328627|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677101|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677102|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677103|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677104|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677105|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677106|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677107|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677108|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677109|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677110|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677111|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677112|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677113|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677114|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677115|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677116|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677117|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
679773|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
677118|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677119|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677120|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677121|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677122|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677123|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677124|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677125|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677126|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677127|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677128|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677129|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677130|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677131|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677132|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677133|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677134|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677135|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677136|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677137|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677138|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677139|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677140|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677141|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677142|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677143|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677144|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677145|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677146|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677147|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677148|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677149|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677150|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677151|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677152|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677153|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677154|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677155|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677156|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
679774|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
677157|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677158|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677159|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677160|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677161|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677162|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677163|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677164|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677165|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677166|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677167|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677168|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677169|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677170|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677171|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677172|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677173|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677174|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677175|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677176|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677177|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677178|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677179|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677180|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677181|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677182|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677183|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677184|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677185|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677186|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677187|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677188|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677189|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677190|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677191|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677192|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677193|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677194|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677234|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677195|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677196|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677197|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677198|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677199|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677200|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677201|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677202|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677203|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677204|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677205|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677206|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677207|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677208|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677209|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677210|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677211|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677212|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677213|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677214|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677215|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677216|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677217|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677218|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677219|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677220|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677221|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677222|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677223|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677224|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677225|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677226|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677227|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677228|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677229|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677230|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677231|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677232|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677233|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677236|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677237|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677238|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677239|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677240|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677241|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677242|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677243|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677244|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677245|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677246|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677247|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677248|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677249|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677250|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677251|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677252|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677253|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677254|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677255|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677256|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677257|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677258|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677259|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677260|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677261|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677262|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677263|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677264|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677265|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677266|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677267|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677268|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677269|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677270|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677271|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677272|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677273|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677582|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677274|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677275|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677276|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677277|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677278|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677279|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677280|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677281|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677282|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677283|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677284|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677285|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677286|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677287|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677288|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677289|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677290|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677291|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677292|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677293|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677294|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677295|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677296|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677297|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677298|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677299|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677300|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677301|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677302|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677303|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677304|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677305|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677306|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677307|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677308|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677309|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677310|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677311|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677583|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677312|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677313|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677314|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677315|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677316|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677317|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677318|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677319|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677320|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677321|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677322|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677323|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677324|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677325|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677326|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677327|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677328|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677329|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677330|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677331|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677332|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677333|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677334|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677335|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677336|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677337|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677338|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677339|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677340|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677341|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677342|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677343|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677344|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677345|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677346|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677347|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677348|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677349|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677350|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
679775|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
677351|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677352|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677353|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677354|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677355|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677356|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677357|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677358|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677359|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677360|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677361|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677362|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677363|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677364|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677365|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677366|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677367|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677368|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677369|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677370|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677371|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677372|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677373|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677374|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677375|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677376|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677377|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677378|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677379|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677380|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677381|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677382|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677383|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677384|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677385|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677386|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677387|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677388|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678347|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677389|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677390|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677391|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677392|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677393|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677394|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677395|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677396|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677397|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677398|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677399|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677400|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677401|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677402|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677403|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677404|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677405|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677406|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677407|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677408|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677409|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677410|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677411|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677412|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677413|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677414|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677415|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677416|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677417|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677418|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677419|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677420|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677421|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677422|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677423|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677424|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677425|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677426|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677427|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
679776|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
677428|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677429|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677430|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677431|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677432|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677433|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677434|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677435|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677436|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677437|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677438|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677439|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677440|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677441|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677442|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677443|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677444|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677445|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677446|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677447|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677448|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677449|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677450|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677451|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677452|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677453|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677454|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677455|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677456|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677457|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677458|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677459|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677460|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677461|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677462|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677463|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677464|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677465|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678348|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677466|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677467|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677468|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677469|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677470|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677471|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677472|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677473|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677474|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677475|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677476|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677477|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677478|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677479|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677480|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677481|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677482|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677483|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677484|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677485|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677486|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677487|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677488|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677489|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677490|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677491|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677492|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677493|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677494|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677495|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677496|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677497|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677498|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677499|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677500|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677501|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677502|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677503|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677504|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677506|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677507|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677508|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677509|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677510|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677511|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677512|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677513|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677514|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677515|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677516|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677517|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677518|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677519|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677520|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677521|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677522|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677523|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677524|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677525|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677526|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677527|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677528|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677529|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677530|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677531|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677532|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677533|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677534|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677535|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677536|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677537|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677538|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677539|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677540|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677541|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677542|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677543|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678656|NCT00328263|P1|Participant Flow|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
677544|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677545|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677546|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677547|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677548|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677549|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677550|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677551|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677552|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677553|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677554|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677555|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677556|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677557|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677558|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677559|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677560|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677561|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677562|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677563|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677564|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677565|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677566|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677567|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677568|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677569|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677570|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677571|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677572|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677573|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677574|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677575|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677576|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677577|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677578|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677579|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677580|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677581|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677584|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677585|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677586|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677587|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677588|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677589|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677590|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677591|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677592|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677593|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677594|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677595|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677596|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677597|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677598|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677599|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677600|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677601|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677602|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677603|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677604|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677605|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677606|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677607|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677608|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677609|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677610|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677611|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677612|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677613|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677614|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677615|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677616|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677617|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677618|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677619|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677620|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677621|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678657|NCT00328263|O2|Outcome|Placebo|98g/day of placebo (devoid of microorganisms)
677622|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677623|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677624|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677625|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677626|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677627|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677628|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677629|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677630|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677631|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677632|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677633|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677634|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677635|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677636|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677637|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677638|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677639|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677640|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677641|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677642|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677643|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677644|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677645|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677646|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677647|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677648|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677649|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677650|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677651|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677652|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677653|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677654|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677655|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677656|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677657|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677658|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677659|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678658|NCT00328263|O1|Outcome|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
677660|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677661|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677662|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677663|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677664|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677665|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677666|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677667|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677668|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677669|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677670|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677671|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677672|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677673|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677674|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677675|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677676|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677677|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677678|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677679|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677680|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677681|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677682|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677683|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677684|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677685|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677686|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677687|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677688|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677689|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677690|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677691|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677692|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677693|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677694|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677695|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677696|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677697|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677698|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678659|NCT00328263|E2|Reported Event|Placebo|98g/day of placebo (devoid of microorganisms)
677699|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677700|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677701|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677702|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677703|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677704|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677705|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677706|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677707|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677708|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677709|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677710|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677711|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677712|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677713|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677714|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677715|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677716|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677717|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677718|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677719|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677720|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677721|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677722|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677723|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677724|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677725|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677726|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677727|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677728|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677729|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677730|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677731|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677732|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677733|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677734|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677735|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677736|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677737|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677738|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677739|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677740|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677741|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677742|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677743|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677744|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677745|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677746|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677747|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677748|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677749|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677750|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677751|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677752|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677753|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677754|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677755|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677756|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677757|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677758|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677759|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677760|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677761|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677762|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677763|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677764|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677765|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677766|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677767|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677768|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677769|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677770|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677771|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677772|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677773|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677774|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678660|NCT00328263|E1|Reported Event|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
677775|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677776|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677777|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677778|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677779|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677780|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677781|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677782|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677783|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677784|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677785|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677786|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677787|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677788|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677789|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677790|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677791|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677792|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677793|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677794|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677795|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677796|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677797|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677798|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677799|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677800|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677801|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677802|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677803|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677804|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677805|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677806|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677807|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677808|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677809|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677810|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677811|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677812|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677813|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677814|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677815|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677816|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677817|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677818|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677819|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677820|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677821|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677822|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677823|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677824|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677825|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677826|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677827|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677828|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677829|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677830|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677831|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677832|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677833|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677834|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677835|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677836|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677837|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677838|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677839|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677840|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677841|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677842|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677843|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677844|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677845|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677846|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677847|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677848|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677849|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677850|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678702|NCT00328094|B3|Baseline|Total|Total of all reporting groups
677851|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677852|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677853|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677854|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677855|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677856|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677857|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677858|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677859|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677860|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677861|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677862|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677863|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677864|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677865|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677866|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677867|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677868|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677869|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677870|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677871|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677872|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677873|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677874|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677875|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677876|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677877|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677878|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677879|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677880|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677881|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677882|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677883|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677884|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677885|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677886|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677887|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677888|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677889|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677890|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677891|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677892|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677893|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677894|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677895|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677896|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677897|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677898|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677899|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677900|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677901|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677902|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677903|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677904|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677905|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677906|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677907|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677908|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677909|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677910|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677911|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677912|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677913|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677914|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677915|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677916|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677917|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677918|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677919|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677920|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677921|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677922|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677923|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677924|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677925|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677926|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678703|NCT00328094|B2|Baseline|Intermittent Insulin Bolus|Intermittent insulin boluses group
677927|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677928|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677929|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677930|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677931|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677932|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677933|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677934|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677935|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677936|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677937|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677938|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677939|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677940|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677941|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677942|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677943|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677944|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677945|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677946|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677947|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677948|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677949|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677950|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677951|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677952|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677953|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677954|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677955|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677956|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677957|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677958|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677959|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677960|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677961|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677962|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677963|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677964|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677965|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677966|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677967|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677968|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677969|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677970|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677971|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677972|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677973|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677974|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677975|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677976|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677977|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677978|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677979|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677980|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677981|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677982|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677983|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677984|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677985|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677986|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677987|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677988|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
677989|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
677990|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
677991|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
677992|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677993|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677994|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
677995|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677996|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677997|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
677998|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
677999|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678000|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678001|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678002|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678704|NCT00328094|B1|Baseline|Continuous Insulin Infusion|Tight glucose group with insulin infusion
678003|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678004|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678005|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678006|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678007|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678008|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678009|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678010|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678011|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678012|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678013|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678014|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678015|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678016|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678017|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678018|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678019|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678020|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678021|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678022|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678023|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678024|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678025|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678026|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678027|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678028|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678029|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678030|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678031|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678032|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678033|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678034|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678035|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678036|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678037|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678038|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678039|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678040|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678041|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678042|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678043|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678044|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678045|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678046|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678047|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678048|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678049|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678050|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678051|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678052|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678053|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678054|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678055|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678056|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678057|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678058|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678059|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678060|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678061|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678062|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678063|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678064|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678065|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678066|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678067|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678068|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678069|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678070|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678071|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678072|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678073|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678074|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678075|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678076|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678077|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678078|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678705|NCT00328094|P2|Participant Flow|Intermittent Insulin Bolus|Intermittent insulin boluses group
678079|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678080|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678081|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678082|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678083|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678084|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678085|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678086|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678087|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678088|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678089|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678090|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678091|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678092|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678093|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678094|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678095|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678096|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678097|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678098|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678099|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678100|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678101|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678102|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678103|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678104|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678105|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678106|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678107|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678108|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678109|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678110|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678111|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678112|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678113|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678114|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678115|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678116|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678117|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678118|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678119|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678120|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678121|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678122|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678123|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678124|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678125|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678126|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678127|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678128|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678129|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678130|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678131|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678132|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678133|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678134|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678135|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678136|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678137|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678138|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678139|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678140|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678141|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678142|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678143|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678144|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678145|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678146|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678147|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678148|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678149|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678150|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678151|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678152|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678153|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678154|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678706|NCT00328094|P1|Participant Flow|Continuous Insulin Infusion|Tight glucose group with insulin infusion
678155|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678156|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678157|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678158|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678159|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678160|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678161|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678162|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678163|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678164|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678165|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678166|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678167|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678168|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678169|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678170|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678171|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678172|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678173|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678174|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678175|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678176|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678177|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678178|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678179|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678180|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678181|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678182|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678183|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678184|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678185|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678186|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678187|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678188|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678189|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678190|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678191|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678192|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678193|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678194|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678195|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678196|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678197|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678198|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678199|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678200|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678201|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678202|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678203|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678204|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678205|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678206|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678207|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678208|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678209|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678210|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678211|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678212|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678213|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678214|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678215|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678216|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678217|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678218|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678219|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678220|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678221|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678222|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678223|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678224|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678225|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678226|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678227|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678228|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678229|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678230|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678707|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
678231|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678232|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678233|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678234|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678235|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678236|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678237|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678238|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678239|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678240|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678241|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678242|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678243|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678244|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678245|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678246|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678247|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678248|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678249|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678250|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678251|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678252|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678253|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678254|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678255|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678256|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678257|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678258|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678259|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678260|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678261|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678262|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678263|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678264|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678265|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678266|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678267|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678268|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678269|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678270|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678271|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678272|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678273|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678274|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678275|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678276|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678277|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678278|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678279|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678280|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678281|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678282|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678283|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678284|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678285|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678286|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678287|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678288|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678289|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678290|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678291|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678292|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678293|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678294|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678295|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678296|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678297|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678298|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678299|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678300|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678301|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678302|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678303|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678304|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678305|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678306|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678307|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678708|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
678308|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678309|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678310|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678311|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678312|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678313|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678314|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678315|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678316|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678317|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678318|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678319|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678320|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678321|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678322|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678323|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678324|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678325|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678326|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678327|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678328|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678329|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678330|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678331|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678332|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678333|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678334|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678335|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678336|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678337|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678338|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678339|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678340|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678341|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678342|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678343|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678344|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678345|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678346|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678349|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678350|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678351|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678352|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678353|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678354|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678355|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678356|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678357|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678358|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678359|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678360|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678361|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678362|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678363|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678364|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678365|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678366|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678367|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678368|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678369|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678370|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678371|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678372|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678373|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678374|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678375|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678376|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678377|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678378|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678379|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678380|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678381|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678382|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678383|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678384|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678385|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678386|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678387|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678709|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
678388|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678389|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678390|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678391|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678392|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678393|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678394|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678395|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678396|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678397|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678398|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678399|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678400|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678401|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678402|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678403|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678404|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678405|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678406|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678407|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678408|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678409|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678410|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678411|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678412|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678413|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678414|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678415|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678416|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678417|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678418|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678419|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678420|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678421|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678422|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678423|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678424|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678425|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678426|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678427|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678428|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678429|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678430|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678431|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678432|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678433|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678434|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678435|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678436|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678437|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678438|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678439|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678440|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678441|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678442|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678443|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678444|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678445|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678446|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678447|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678448|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678449|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678450|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678451|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678452|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678453|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678454|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678455|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678456|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678457|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678458|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678459|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678460|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678461|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678462|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678463|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678464|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678465|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678710|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
678466|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678467|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678468|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678469|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678470|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678471|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678472|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678473|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678474|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678475|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678476|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678477|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678478|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678479|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678480|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678481|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678482|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678483|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678484|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678485|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678486|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678487|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678488|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678489|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678490|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678491|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678492|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678493|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678494|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678495|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678496|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678497|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678498|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678499|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678500|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678501|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678502|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678503|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678504|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678505|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678506|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678507|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678508|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678509|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678510|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678511|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678512|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678513|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678514|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678515|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678516|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678517|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678518|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678519|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678520|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678521|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678522|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678523|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678524|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678525|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678526|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678527|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678528|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678529|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678530|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678531|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678532|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678533|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678534|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678535|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678536|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678537|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678538|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678539|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678540|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678541|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678711|NCT00328094|E2|Reported Event|Intermittent Insulin Bolus|Intermittent insulin boluses group
678542|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678543|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678544|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678545|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678546|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678547|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678548|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678549|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678550|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678551|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678552|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678553|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678554|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678555|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678556|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678557|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678558|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678559|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678560|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678561|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678562|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678563|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678564|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678565|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678566|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678567|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678568|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678569|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678570|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678571|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678572|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678573|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678574|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678575|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678576|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678577|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678578|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678712|NCT00328094|E1|Reported Event|Continuous Insulin Infusion|Tight glucose group with insulin infusion
678579|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678580|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678581|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678582|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678583|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678584|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678585|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678586|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678587|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678588|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678589|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678590|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678591|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678592|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678593|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678594|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678595|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678596|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678597|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678598|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
678599|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
678600|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
678601|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|"Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 25 mg + Pioglitazone 15 mg~Alogliptin 25 mg + Pioglitazone 30 mg~Alogliptin 25 mg + Pioglitazone 45 mg"
678602|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|"Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 12.5 mg + Pioglitazone 15 mg~Alogliptin 12.5 mg + Pioglitazone 30 mg~Alogliptin 12.5 mg + Pioglitazone 45 mg"
678603|NCT00328627|O1|Outcome|Pioglitazone Alone|"Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Placebo + Pioglitazone 15 mg~Placebo + Pioglitazone 30 mg~Placebo + Pioglitazone 45 mg"
678604|NCT00328627|E12|Reported Event|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678605|NCT00328627|E11|Reported Event|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678606|NCT00328627|E10|Reported Event|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
678607|NCT00328627|E9|Reported Event|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678608|NCT00328627|E8|Reported Event|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678609|NCT00328627|E7|Reported Event|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
678610|NCT00328627|E6|Reported Event|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678611|NCT00328627|E5|Reported Event|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678612|NCT00328627|E4|Reported Event|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
678613|NCT00328627|E3|Reported Event|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678614|NCT00328627|E2|Reported Event|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678713|NCT00328042|B3|Baseline|Total|Total of all reporting groups
678615|NCT00328627|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
678616|NCT00328614|B7|Baseline|Total|Total of all reporting groups
678617|NCT00328614|B6|Baseline|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678618|NCT00328614|B5|Baseline|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678619|NCT00328614|B4|Baseline|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678620|NCT00328614|B3|Baseline|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678621|NCT00328614|B2|Baseline|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678622|NCT00328614|B1|Baseline|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678623|NCT00328614|P6|Participant Flow|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678624|NCT00328614|P5|Participant Flow|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678625|NCT00328614|P4|Participant Flow|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678626|NCT00328614|P3|Participant Flow|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678627|NCT00328614|P2|Participant Flow|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678628|NCT00328614|P1|Participant Flow|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678629|NCT00328614|O1|Outcome|Samarium-153|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678630|NCT00328614|E6|Reported Event|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678631|NCT00328614|E5|Reported Event|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678632|NCT00328614|E4|Reported Event|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678633|NCT00328614|E3|Reported Event|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678634|NCT00328614|E2|Reported Event|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678635|NCT00328614|E1|Reported Event|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
678636|NCT00328562|B1|Baseline|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
678637|NCT00328562|P1|Participant Flow|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy"
678638|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
678639|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
678640|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
678641|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
678642|NCT00328562|E1|Reported Event|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
678643|NCT00328510|B3|Baseline|Total|Total of all reporting groups
678644|NCT00328510|B2|Baseline|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
678645|NCT00328510|B1|Baseline|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
678646|NCT00328510|P2|Participant Flow|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
678647|NCT00328510|P1|Participant Flow|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
678648|NCT00328510|O2|Outcome|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
678649|NCT00328510|O1|Outcome|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
678650|NCT00328510|E2|Reported Event|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
678651|NCT00328510|E1|Reported Event|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
678652|NCT00328263|B3|Baseline|Total|Total of all reporting groups
678653|NCT00328263|B2|Baseline|Placebo|98g/day of placebo (devoid of microorganisms)
678654|NCT00328263|B1|Baseline|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
678655|NCT00328263|P2|Participant Flow|Placebo|98g/day of placebo (devoid of microorganisms)
678661|NCT00328198|B1|Baseline|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678662|NCT00328198|P1|Participant Flow|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678663|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678664|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678665|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678666|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678667|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678668|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678669|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678670|NCT00328198|E1|Reported Event|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
678671|NCT00328172|B6|Baseline|Total|Total of all reporting groups
678672|NCT00328172|B5|Baseline|Metformin|Patients randomized to receive treatment with metformin
678673|NCT00328172|B4|Baseline|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
678674|NCT00328172|B3|Baseline|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
678675|NCT00328172|B2|Baseline|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
678676|NCT00328172|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
678677|NCT00328172|P5|Participant Flow|Metformin|Patients randomized to receive treatment with metformin
678678|NCT00328172|P4|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
678679|NCT00328172|P3|Participant Flow|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
678680|NCT00328172|P2|Participant Flow|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
678681|NCT00328172|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
678682|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
678683|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
678684|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
678685|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
678686|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
678687|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
678688|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
678689|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
678690|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
678691|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
678692|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
678693|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
678694|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
678695|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
678696|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
678697|NCT00328172|E5|Reported Event|Metformin|Patients randomized to receive treatment with metformin
678698|NCT00328172|E4|Reported Event|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
678699|NCT00328172|E3|Reported Event|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
678700|NCT00328172|E2|Reported Event|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
678701|NCT00328172|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
678714|NCT00328042|B2|Baseline|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
678715|NCT00328042|B1|Baseline|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
678716|NCT00328042|P2|Participant Flow|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
678717|NCT00328042|P1|Participant Flow|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
678718|NCT00328042|O2|Outcome|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
678719|NCT00328042|O1|Outcome|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
678720|NCT00328042|O2|Outcome|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
678721|NCT00328042|O1|Outcome|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
678722|NCT00328042|E2|Reported Event|Information-Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
678723|NCT00328042|E1|Reported Event|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
678724|NCT00328016|B3|Baseline|Total|Total of all reporting groups
678725|NCT00328016|B2|Baseline|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery period.
678726|NCT00328016|B1|Baseline|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period.
678727|NCT00328016|P2|Participant Flow|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery period.
678728|NCT00328016|P1|Participant Flow|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period.
678729|NCT00328016|O2|Outcome|Control Group|Practiced passive attention to breathing
678730|NCT00328016|O1|Outcome|Device Guided Breathing|Practiced slow breathing using guided breathing device
678731|NCT00328016|O2|Outcome|Control Group|Practiced passive attention to breathing
678732|NCT00328016|O1|Outcome|Device Guided Breathing|Practiced slow breathing using guided breathing device
678733|NCT00328016|O2|Outcome|Control Group|Practiced passive attention to breathing
678734|NCT00328016|O1|Outcome|Device Guided Breathing|Practiced slow breathing using Guided Breathing Device
678735|NCT00328016|E2|Reported Event|Control Group|The Control Group were instructed to sit in the same matter, passively attend to their breathing, and silently repeat 'one' during each exhalation. If thoughts came to mind, they were instructed to calmly refocus attention on breathing. Following two sessions of practice of passive attention to breathing, blood pressure and breathing parameters of each subject were also monitored during a 10 min baseline, 15 min passive attention to breathing and 10 min recovery.
678736|NCT00328016|E1|Reported Event|Device Guided Breathing|The Device Guided Breathing (DGB) group were instructed to sit comfortably with eyes closed and arms and legs uncrossed. Individual breathing rate was initially determined from an expandable band around the torso connected to a commercially available device (RESPeRATE, Lod, Israel) that presented distinctive tones via earphone. Each subject was instructed to inspire during ascending tones and expire during descending tones, following two training sessions, respiration, blood pressure and breathing parameters were monitored during a 10 min rest period, a 15 min guided breathing task period, and a 10 min recovery period during an experimental session on a subsequent day.
678737|NCT00327717|B3|Baseline|Total|Total of all reporting groups
678738|NCT00327717|B2|Baseline|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678739|NCT00327717|B1|Baseline|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678740|NCT00327717|P2|Participant Flow|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678841|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678842|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678741|NCT00327717|P1|Participant Flow|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678742|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678743|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678744|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678745|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678746|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678747|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678748|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678749|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678750|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678751|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678752|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678753|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678754|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678755|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678756|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678757|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678758|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678759|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678760|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678761|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678762|NCT00327717|E2|Reported Event|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
678763|NCT00327717|E1|Reported Event|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
678764|NCT00327470|B3|Baseline|Total|Total of all reporting groups
678843|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678844|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678765|NCT00327470|B2|Baseline|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678766|NCT00327470|B1|Baseline|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678767|NCT00327470|P2|Participant Flow|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678768|NCT00327470|P1|Participant Flow|Early Age-related Macular Degeneration (AMD)|Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678769|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678770|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678771|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678772|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678773|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678774|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678775|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678776|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678777|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678778|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678779|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678805|NCT00327340|B2|Baseline|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
678780|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678781|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678782|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678783|NCT00327470|E2|Reported Event|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678784|NCT00327470|E1|Reported Event|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
678785|NCT00327444|B3|Baseline|Total|Total of all reporting groups
678786|NCT00327444|B2|Baseline|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
678787|NCT00327444|B1|Baseline|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
678788|NCT00327444|P2|Participant Flow|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
678789|NCT00327444|P1|Participant Flow|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
678790|NCT00327444|O2|Outcome|Open-Label (OL) Period|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
678791|NCT00327444|O1|Outcome|Double Blind (DB) Period|Participants with advanced ovarian cancer administered placebo or 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period.
678792|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
678793|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
678794|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
678795|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
678796|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
678797|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
678798|NCT00327444|E2|Reported Event|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
678799|NCT00327444|E1|Reported Event|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
678800|NCT00327392|B1|Baseline|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
678801|NCT00327392|P1|Participant Flow|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
678802|NCT00327392|O1|Outcome|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
678803|NCT00327392|E1|Reported Event|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
678804|NCT00327340|B3|Baseline|Total|Total of all reporting groups
678839|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678840|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678806|NCT00327340|B1|Baseline|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
678807|NCT00327340|P2|Participant Flow|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
678808|NCT00327340|P1|Participant Flow|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
678809|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
678810|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
678811|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
678812|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
678813|NCT00327340|O2|Outcome|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
678814|NCT00327340|O1|Outcome|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
678815|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
678816|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
678817|NCT00327340|E2|Reported Event|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
678818|NCT00327340|E1|Reported Event|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
678819|NCT00327171|B3|Baseline|Total|Total of all reporting groups
678820|NCT00327171|B2|Baseline|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678821|NCT00327171|B1|Baseline|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678822|NCT00327171|P2|Participant Flow|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678823|NCT00327171|P1|Participant Flow|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678824|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678825|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678826|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678827|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678828|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678829|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678830|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678831|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678832|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678833|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678834|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678835|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678836|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678837|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678838|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678845|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678846|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678847|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678848|NCT00327171|E2|Reported Event|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
678849|NCT00327171|E1|Reported Event|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
678850|NCT00327015|B5|Baseline|Total|Total of all reporting groups
678851|NCT00327015|B4|Baseline|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678852|NCT00327015|B3|Baseline|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678853|NCT00327015|B2|Baseline|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678854|NCT00327015|B1|Baseline|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678855|NCT00327015|P4|Participant Flow|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678856|NCT00327015|P3|Participant Flow|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678857|NCT00327015|P2|Participant Flow|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678858|NCT00327015|P1|Participant Flow|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678859|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678860|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678861|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678862|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678863|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678864|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678865|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678866|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678867|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678868|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678869|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
679001|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
678870|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678871|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678872|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678873|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678874|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678875|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678876|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678877|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678878|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678879|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678880|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678881|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678882|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678883|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678884|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678885|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678886|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678887|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678888|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678889|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678890|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678891|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678892|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678893|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678894|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678895|NCT00327015|E4|Reported Event|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678896|NCT00327015|E3|Reported Event|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
678897|NCT00327015|E2|Reported Event|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
678898|NCT00327015|E1|Reported Event|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
678899|NCT00326963|B1|Baseline|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678900|NCT00326963|P1|Participant Flow|Enfuvirtide+PI+ARV’s|Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½” needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
678901|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678902|NCT00326963|O1|Outcome|Enfuride+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678903|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678904|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678905|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678906|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678907|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678908|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678909|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678910|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678911|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678912|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678913|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678914|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678915|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678916|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678917|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678918|NCT00326963|E1|Reported Event|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
678919|NCT00326950|B1|Baseline|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
678920|NCT00326950|P1|Participant Flow|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
678921|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
678922|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
678923|NCT00326950|E1|Reported Event|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
678924|NCT00326924|B3|Baseline|Total|Total of all reporting groups
678925|NCT00326924|B2|Baseline|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
678926|NCT00326924|B1|Baseline|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
678927|NCT00326924|P2|Participant Flow|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
678928|NCT00326924|P1|Participant Flow|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
678929|NCT00326924|O2|Outcome|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
678930|NCT00326924|O1|Outcome|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
678931|NCT00326924|O2|Outcome|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
678932|NCT00326924|O1|Outcome|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
678933|NCT00326924|O2|Outcome|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
678934|NCT00326924|O1|Outcome|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
678935|NCT00326924|O2|Outcome|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
678936|NCT00326924|O1|Outcome|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
678937|NCT00326924|E2|Reported Event|Standard PRBCs|"PRBCs 'stored' as per hospital policy.~Transfusion: PRBC blood transfusions."
678938|NCT00326924|E1|Reported Event|Biological|"PRBCs that are less than 7 days old are considered 'fresh'.~Transfusion: PRBC blood transfusions."
678939|NCT00326911|B3|Baseline|Total|Total of all reporting groups
678940|NCT00326911|B2|Baseline|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678941|NCT00326911|B1|Baseline|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678942|NCT00326911|P2|Participant Flow|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678943|NCT00326911|P1|Participant Flow|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
679777|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
678944|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678945|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678946|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678947|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678948|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678949|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678950|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678951|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678952|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678953|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678954|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678955|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678956|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
679002|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
678957|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678958|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678959|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678960|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678961|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678962|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678963|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678964|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678965|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678966|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678967|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678968|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678969|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
679116|NCT00326716|E2|Reported Event|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
678970|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678971|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678972|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678973|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678974|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678975|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678976|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678977|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678978|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678979|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678980|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678981|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678982|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
679117|NCT00326716|E1|Reported Event|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
679118|NCT00326612|B3|Baseline|Total|Total of all reporting groups
678983|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678984|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678985|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678986|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678987|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678988|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678989|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678990|NCT00326911|E2|Reported Event|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678991|NCT00326911|E1|Reported Event|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
678992|NCT00326898|B4|Baseline|Total|Total of all reporting groups
678993|NCT00326898|B3|Baseline|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
678994|NCT00326898|B2|Baseline|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
678995|NCT00326898|B1|Baseline|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
678996|NCT00326898|P3|Participant Flow|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
678997|NCT00326898|P2|Participant Flow|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
678998|NCT00326898|P1|Participant Flow|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
678999|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
679000|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
679119|NCT00326612|B2|Baseline|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
679003|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
679004|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
679005|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
679006|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
679007|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
679008|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
679009|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
679010|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
679011|NCT00326898|E3|Reported Event|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
679012|NCT00326898|E2|Reported Event|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
679013|NCT00326898|E1|Reported Event|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
679014|NCT00326885|B1|Baseline|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679015|NCT00326885|P1|Participant Flow|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679016|NCT00326885|O1|Outcome|Full Analysis Set|
679017|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679018|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679019|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679020|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679021|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679022|NCT00326885|E1|Reported Event|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
679023|NCT00326872|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679024|NCT00326872|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679025|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679026|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679120|NCT00326612|B1|Baseline|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
679121|NCT00326612|P2|Participant Flow|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
679027|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679028|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679029|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679030|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679031|NCT00326872|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
679032|NCT00326781|B3|Baseline|Total|Total of all reporting groups
679033|NCT00326781|B2|Baseline|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
679034|NCT00326781|B1|Baseline|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
679035|NCT00326781|P2|Participant Flow|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
679036|NCT00326781|P1|Participant Flow|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
679037|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
679038|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
679039|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
679040|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
679041|NCT00326781|E2|Reported Event|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
679042|NCT00326781|E1|Reported Event|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
679043|NCT00326716|B3|Baseline|Total|Total of all reporting groups
679044|NCT00326716|B2|Baseline|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679045|NCT00326716|B1|Baseline|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679046|NCT00326716|P4|Participant Flow|Infants ATV 400 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.
679047|NCT00326716|P3|Participant Flow|Infants ATV 300 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy.
679048|NCT00326716|P2|Participant Flow|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679049|NCT00326716|P1|Participant Flow|Mother ATV 300 mg / RTV 100 mg|Mothers receiving atazanavir (ATV) / ritonavir (RTV) 300/100 mg once daily (QD) + lamivudine (ZDV) / zidovudine (3TC) 300/150 mg twice daily (BID) during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679050|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679051|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679052|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679053|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679054|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679055|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679056|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679057|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679058|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679059|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679060|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679061|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679062|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679063|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infansts of mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679064|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679065|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Infants born to mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679066|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679067|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679068|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679069|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679122|NCT00326612|P1|Participant Flow|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
679123|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
679778|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679070|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679071|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679072|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679073|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679074|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679075|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679076|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679077|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679078|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679079|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679080|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679081|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679082|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679083|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679084|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679085|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679086|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679087|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679088|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679089|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679090|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679091|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679092|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679093|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679094|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
679095|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
679096|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679097|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679098|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
679099|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
679100|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
679101|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
679102|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|
679103|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|
679104|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679105|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679106|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679107|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679108|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679109|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679110|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679111|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679112|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679113|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679114|NCT00326716|E4|Reported Event|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679115|NCT00326716|E3|Reported Event|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
679124|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
679125|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
679126|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
679127|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
679128|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
679129|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
679130|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
679131|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
679132|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
679133|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
679134|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
679135|NCT00326612|O2|Outcome|Rectal Diazepam|Median time to seizure cessation from medication administration to seizures stop time.
679136|NCT00326612|O1|Outcome|Intranasal Midazolam|Median time to seizure cessation from medication administration to seizures stop time.
679137|NCT00326612|E2|Reported Event|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
679138|NCT00326612|E1|Reported Event|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
679139|NCT00326599|B5|Baseline|Total|Total of all reporting groups
679140|NCT00326599|B4|Baseline|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679141|NCT00326599|B3|Baseline|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679142|NCT00326599|B2|Baseline|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679143|NCT00326599|B1|Baseline|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679144|NCT00326599|P4|Participant Flow|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679145|NCT00326599|P3|Participant Flow|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679146|NCT00326599|P2|Participant Flow|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679147|NCT00326599|P1|Participant Flow|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679148|NCT00326599|O1|Outcome|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679149|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679150|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679151|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679152|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679153|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679154|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679155|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679156|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679157|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679158|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679159|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679160|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679161|NCT00326599|E4|Reported Event|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679162|NCT00326599|E3|Reported Event|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679163|NCT00326599|E2|Reported Event|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679164|NCT00326599|E1|Reported Event|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
679165|NCT00326495|B1|Baseline|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
679166|NCT00326495|P1|Participant Flow|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
679167|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
679168|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
679169|NCT00326495|E1|Reported Event|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
679170|NCT00326417|B3|Baseline|Total|Total of all reporting groups
679171|NCT00326417|B2|Baseline|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679172|NCT00326417|B1|Baseline|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679173|NCT00326417|P4|Participant Flow|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
679174|NCT00326417|P3|Participant Flow|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679175|NCT00326417|P2|Participant Flow|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679176|NCT00326417|P1|Participant Flow|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
679177|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679178|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679179|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679180|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679181|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679182|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679183|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679184|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679185|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679186|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679187|NCT00326417|E4|Reported Event|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
679188|NCT00326417|E3|Reported Event|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
679189|NCT00326417|E2|Reported Event|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
679190|NCT00326417|E1|Reported Event|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
679191|NCT00326196|B3|Baseline|Total|Total of all reporting groups
679192|NCT00326196|B2|Baseline|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
679193|NCT00326196|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous coronary intervention
679194|NCT00326196|P2|Participant Flow|Coronary Artery Bypass Graft|Initial revascularization with Coronary artery bypass graft (CABG). Multiple arterial conduits for suitable target vessels will be encouraged in the surgical treatment.
679195|NCT00326196|P1|Participant Flow|Percutaneous Coronary Intervention|"Initial revascularization with Percutaneous coronary intervention. Whenever possible, drug-eluting stents will be used in the percutaneous treatment. The use of multiple stents to achieve a complete revascularization will be encouraged in the PCI treatment"
679196|NCT00326196|O2|Outcome|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
679197|NCT00326196|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous coronary intervention
679198|NCT00326196|E2|Reported Event|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
679199|NCT00326196|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous coronary intervention
679200|NCT00326183|B3|Baseline|Total|Total of all reporting groups
679201|NCT00326183|B2|Baseline|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679202|NCT00326183|B1|Baseline|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679203|NCT00326183|P2|Participant Flow|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679204|NCT00326183|P1|Participant Flow|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679205|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679206|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679207|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679208|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679209|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679210|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679211|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679212|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679213|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679214|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679215|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679216|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679217|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679218|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679219|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679220|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679221|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679222|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679223|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679224|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679225|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679226|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679227|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
679228|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
679276|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
679229|NCT00326170|B1|Baseline|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
679230|NCT00326170|P1|Participant Flow|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
679231|NCT00326170|O1|Outcome|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
679232|NCT00326170|E1|Reported Event|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
679233|NCT00326118|B3|Baseline|Total|Total of all reporting groups
679234|NCT00326118|B2|Baseline|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679235|NCT00326118|B1|Baseline|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679236|NCT00326118|P2|Participant Flow|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679237|NCT00326118|P1|Participant Flow|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679238|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679239|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679240|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679241|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679242|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679243|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679244|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679245|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679246|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679247|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679248|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679249|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679250|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679251|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679252|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679253|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679254|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679255|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679256|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679257|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679258|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679259|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679260|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm
679261|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679262|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679263|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679264|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679265|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679266|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679267|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679268|NCT00326118|E2|Reported Event|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679269|NCT00326118|E1|Reported Event|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
679270|NCT00326001|B3|Baseline|Total|Total of all reporting groups
679271|NCT00326001|B2|Baseline|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
679272|NCT00326001|B1|Baseline|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
679273|NCT00326001|P2|Participant Flow|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
679274|NCT00326001|P1|Participant Flow|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
679275|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
679277|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
679278|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
679279|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
679280|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
679281|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
679282|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
679283|NCT00326001|E2|Reported Event|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
679284|NCT00326001|E1|Reported Event|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
679285|NCT00325897|B3|Baseline|Total|Total of all reporting groups
679286|NCT00325897|B2|Baseline|Placebo|Inactive sugar pill
679287|NCT00325897|B1|Baseline|Azithromycin|Azithromycin, 250 mg
679288|NCT00325897|P2|Participant Flow|Placebo|Inactive sugar pill
679289|NCT00325897|P1|Participant Flow|Azithromycin|Azithromycin, 250 mg
679290|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
679291|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
679292|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
679293|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
679294|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
679295|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
679296|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
679297|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
679298|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
679299|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
679300|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
679301|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
679302|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
679303|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
679304|NCT00325897|E2|Reported Event|Placebo|Inactive sugar pill
679305|NCT00325897|E1|Reported Event|Azithromycin|Azithromycin, 250 mg
679306|NCT00325819|B3|Baseline|Total|Total of all reporting groups
679307|NCT00325819|B2|Baseline|Placebo|Subjects who were randomized to receive placebo
679308|NCT00325819|B1|Baseline|Acetaminophen|Subjects who were randomized to receive acetaminophen
679309|NCT00325819|P2|Participant Flow|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
679310|NCT00325819|P1|Participant Flow|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
679311|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
679312|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
679313|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
679314|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
679315|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
679316|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
679317|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
679318|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
679319|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
679320|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
679321|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
679322|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
679323|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
679324|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
679325|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
679326|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
679327|NCT00325819|E2|Reported Event|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
679328|NCT00325819|E1|Reported Event|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
679329|NCT00325780|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
679330|NCT00325780|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
679331|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
679332|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
679333|NCT00325780|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
679334|NCT00325754|B3|Baseline|Total|Total of all reporting groups
679335|NCT00325754|B2|Baseline|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679336|NCT00325754|B1|Baseline|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679337|NCT00325754|P2|Participant Flow|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679338|NCT00325754|P1|Participant Flow|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679339|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679340|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679341|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679342|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679343|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679344|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679345|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679346|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679347|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679348|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679349|NCT00325754|E2|Reported Event|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
679350|NCT00325754|E1|Reported Event|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
679351|NCT00325598|B3|Baseline|Total|Total of all reporting groups
679352|NCT00325598|B2|Baseline|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
679353|NCT00325598|B1|Baseline|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
679354|NCT00325598|P2|Participant Flow|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
679355|NCT00325598|P1|Participant Flow|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
679356|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
679357|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
679358|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
679359|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
679360|NCT00325598|E4|Reported Event|Cohort 2 (40 Gy) Late Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
679361|NCT00325598|E3|Reported Event|Cohort 2 (40 Gy) Acute Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
679362|NCT00325598|E2|Reported Event|Cohort 1 (36 Gy) Late Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
679363|NCT00325598|E1|Reported Event|Cohort 1 (36 Gy) Acute Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
679364|NCT00325468|B6|Baseline|Total|Total of all reporting groups
679365|NCT00325468|B5|Baseline|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
679366|NCT00325468|B4|Baseline|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679367|NCT00325468|B3|Baseline|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679368|NCT00325468|B2|Baseline|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679369|NCT00325468|B1|Baseline|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679370|NCT00325468|P5|Participant Flow|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
679371|NCT00325468|P4|Participant Flow|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679372|NCT00325468|P3|Participant Flow|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679373|NCT00325468|P2|Participant Flow|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679374|NCT00325468|P1|Participant Flow|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679375|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
679376|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679377|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679378|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679379|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679380|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
679381|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679382|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679383|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679384|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679385|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
679386|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679422|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679387|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679388|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679389|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679390|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
679391|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679392|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679393|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679394|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679395|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
679396|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679397|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679398|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679399|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679400|NCT00325468|E6|Reported Event|All Participants|
679401|NCT00325468|E5|Reported Event|Alendronate 70 mg QW|
679402|NCT00325468|E4|Reported Event|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
679403|NCT00325468|E3|Reported Event|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
679404|NCT00325468|E2|Reported Event|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
679405|NCT00325468|E1|Reported Event|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
679406|NCT00325442|B3|Baseline|Total|Total of all reporting groups
679407|NCT00325442|B2|Baseline|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679408|NCT00325442|B1|Baseline|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679409|NCT00325442|P2|Participant Flow|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679410|NCT00325442|P1|Participant Flow|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679411|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679412|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679413|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679414|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679415|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679416|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679417|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679418|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679419|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679420|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679421|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679779|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679423|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679424|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679425|NCT00325442|O3|Outcome|3.5 - 16 mg|Subjects in this group received 3.5 to 16 mg oral treprostinil twice daily.
679426|NCT00325442|O2|Outcome|1.25 - 3.25 mg|Subjects in this group recieved 1.25 to 3.25 mg oral treprostinil twice daily.
679427|NCT00325442|O1|Outcome|Less Than 1 mg or Discontinuation Due to Adverse Events|Subjects in this group received less than or equal to 1 mg oral treprostinil twice daily or discontinued treatment due to adverse events.
679428|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679429|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679430|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679431|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679432|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679433|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679434|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679435|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679436|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679437|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679438|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679439|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679440|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679441|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679442|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679443|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679444|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679445|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679446|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679447|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679448|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679449|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679450|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679451|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679452|NCT00325442|E2|Reported Event|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
679453|NCT00325442|E1|Reported Event|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
679454|NCT00325416|B3|Baseline|Total|Total of all reporting groups
679455|NCT00325416|B2|Baseline|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679456|NCT00325416|B1|Baseline|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679457|NCT00325416|P2|Participant Flow|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679458|NCT00325416|P1|Participant Flow|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679459|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679482|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679460|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679461|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679462|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679463|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679464|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679465|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679466|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679467|NCT00325416|E2|Reported Event|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679468|NCT00325416|E1|Reported Event|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
679469|NCT00325403|B3|Baseline|Total|Total of all reporting groups
679470|NCT00325403|B2|Baseline|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population
679471|NCT00325403|B1|Baseline|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679472|NCT00325403|P2|Participant Flow|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
679473|NCT00325403|P1|Participant Flow|Placebo|These subjects were randomly allocated to receive matching oral placebo twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
679474|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
679475|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
679476|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
679477|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
679478|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
679479|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
679480|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
679481|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
679705|NCT00324857|E1|Reported Event|Arm 1/Attention Control|Attention Control
679483|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679484|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679485|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679486|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679487|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679488|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679489|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679490|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679491|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679492|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679493|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679494|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679495|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679496|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679497|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679498|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679499|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679500|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679501|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679502|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679503|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679504|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679505|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679506|NCT00325403|E2|Reported Event|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
679507|NCT00325403|E1|Reported Event|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
679508|NCT00325234|B3|Baseline|Total|Total of all reporting groups
679509|NCT00325234|B2|Baseline|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679510|NCT00325234|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679511|NCT00325234|P2|Participant Flow|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679512|NCT00325234|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679513|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679514|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679515|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679516|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679517|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679518|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679519|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679520|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679521|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679522|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679523|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
679524|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
679525|NCT00325234|E2|Reported Event|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
679526|NCT00325234|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
679527|NCT00325195|B4|Baseline|Total|Total of all reporting groups
679528|NCT00325195|B3|Baseline|Placebo|placebo infusion every 2 weeks
679529|NCT00325195|B2|Baseline|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679530|NCT00325195|B1|Baseline|q2 Wks|8 mg pegloticase every 2 weeks
679531|NCT00325195|P3|Participant Flow|Placebo|placebo infusion every 2 weeks
679532|NCT00325195|P2|Participant Flow|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679533|NCT00325195|P1|Participant Flow|q2 Wks|8 mg pegloticase every 2 weeks
679534|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
679535|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679536|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
679537|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
679538|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679539|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
679540|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
679541|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679542|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
679543|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
679544|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679545|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
679546|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
679547|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679548|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
679549|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
679550|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679551|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
679552|NCT00325195|E3|Reported Event|Placebo|placebo infusion every 2 weeks
679553|NCT00325195|E2|Reported Event|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
679554|NCT00325195|E1|Reported Event|q2 Wks|8 mg pegloticase every 2 weeks
679555|NCT00325156|B1|Baseline|Infanrix-IPV+ Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
679556|NCT00325156|P1|Participant Flow|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
679706|NCT00324805|B3|Baseline|Total|Total of all reporting groups
679557|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
679558|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
679559|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
679560|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
679561|NCT00325156|E1|Reported Event|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
679562|NCT00325143|B1|Baseline|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
679563|NCT00325143|P1|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
679564|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
679565|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
679566|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
679567|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
679568|NCT00325143|E1|Reported Event|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
679569|NCT00325130|B3|Baseline|Total|Total of all reporting groups
679570|NCT00325130|B2|Baseline|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679571|NCT00325130|B1|Baseline|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679572|NCT00325130|P2|Participant Flow|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679573|NCT00325130|P1|Participant Flow|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679574|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679575|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679576|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679577|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679578|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679579|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679580|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679581|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679582|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679583|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679584|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679585|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679586|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679587|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679588|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679589|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679590|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679591|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679592|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679593|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679594|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679595|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679596|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679597|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679598|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679599|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679600|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679601|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679602|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679603|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679604|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679605|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679606|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679607|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679608|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679609|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679610|NCT00325130|E2|Reported Event|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679611|NCT00325130|E1|Reported Event|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
679612|NCT00325078|B4|Baseline|Total|Total of all reporting groups
679613|NCT00325078|B3|Baseline|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
679614|NCT00325078|B2|Baseline|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
679615|NCT00325078|B1|Baseline|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
679616|NCT00325078|P3|Participant Flow|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
679617|NCT00325078|P2|Participant Flow|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
679618|NCT00325078|P1|Participant Flow|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
679619|NCT00325078|O2|Outcome|Observation|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
679620|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
679621|NCT00325078|O3|Outcome|Control Volunteers|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
679622|NCT00325078|O2|Outcome|Observation|Subjects with IBD without TNFa inhibitor treatment
679623|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
679624|NCT00325078|E3|Reported Event|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
679625|NCT00325078|E2|Reported Event|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
679626|NCT00325078|E1|Reported Event|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
679627|NCT00325039|B3|Baseline|Total|Total of all reporting groups
679628|NCT00325039|B2|Baseline|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679629|NCT00325039|B1|Baseline|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679630|NCT00325039|P2|Participant Flow|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679631|NCT00325039|P1|Participant Flow|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679632|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679633|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679634|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679635|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679636|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679637|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679638|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679639|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679640|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679641|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679642|NCT00325039|E2|Reported Event|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
679643|NCT00325039|E1|Reported Event|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
679644|NCT00324987|B3|Baseline|Total|Total of all reporting groups
679645|NCT00324987|B2|Baseline|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679763|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679764|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679646|NCT00324987|B1|Baseline|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679647|NCT00324987|P2|Participant Flow|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679648|NCT00324987|P1|Participant Flow|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679649|NCT00324987|O2|Outcome|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679650|NCT00324987|O1|Outcome|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679651|NCT00324987|O2|Outcome|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679652|NCT00324987|O1|Outcome|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679653|NCT00324987|O2|Outcome|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679654|NCT00324987|O1|Outcome|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679655|NCT00324987|O2|Outcome|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679656|NCT00324987|O1|Outcome|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679657|NCT00324987|O2|Outcome|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679658|NCT00324987|O1|Outcome|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679659|NCT00324987|E2|Reported Event|Imatinib|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679660|NCT00324987|E1|Reported Event|Imatinib + Bevacizumab|Patients receive 400 or 800mg imatinib mesylate PO QD on days 1-21 and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
679661|NCT00324961|B1|Baseline|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
679662|NCT00324961|P1|Participant Flow|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
679663|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
679664|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV|10 mg ADV tablets once daily for 104 weeks
679665|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
679666|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
679667|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
679668|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
679669|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
679670|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
679671|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
679672|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
679673|NCT00324961|E1|Reported Event|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
679674|NCT00324896|B3|Baseline|Total|Total of all reporting groups
679675|NCT00324896|B2|Baseline|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
679676|NCT00324896|B1|Baseline|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
679677|NCT00324896|P2|Participant Flow|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
679678|NCT00324896|P1|Participant Flow|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
679679|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
679680|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
679681|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
679682|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
679683|NCT00324896|E2|Reported Event|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
679684|NCT00324896|E1|Reported Event|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
679685|NCT00324870|B1|Baseline|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
679686|NCT00324870|P1|Participant Flow|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
679687|NCT00324870|O1|Outcome|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
679688|NCT00324870|E1|Reported Event|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
679689|NCT00324857|B5|Baseline|Total|Total of all reporting groups
679690|NCT00324857|B4|Baseline|Arm 4/ DA and MI|Decision aid and MI
679691|NCT00324857|B3|Baseline|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
679692|NCT00324857|B2|Baseline|Arm 2/Decision Aid (DA)|Decision Aid video
679693|NCT00324857|B1|Baseline|Arm 1/Attention Control|Attention control
679694|NCT00324857|P4|Participant Flow|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
679695|NCT00324857|P3|Participant Flow|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
679696|NCT00324857|P2|Participant Flow|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
679697|NCT00324857|P1|Participant Flow|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
679698|NCT00324857|O4|Outcome|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
679699|NCT00324857|O3|Outcome|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
679700|NCT00324857|O2|Outcome|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
679701|NCT00324857|O1|Outcome|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
679702|NCT00324857|E4|Reported Event|Arm 4/ DA and MI|Decision Aid and MI
679703|NCT00324857|E3|Reported Event|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
679704|NCT00324857|E2|Reported Event|Arm 2/Decision Aid (DA)|Decision Aid
679707|NCT00324805|B2|Baseline|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679708|NCT00324805|B1|Baseline|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679709|NCT00324805|P2|Participant Flow|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679710|NCT00324805|P1|Participant Flow|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 intravenously (IV) on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679711|NCT00324805|O2|Outcome|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679712|NCT00324805|O1|Outcome|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679713|NCT00324805|O2|Outcome|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679714|NCT00324805|O1|Outcome|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679715|NCT00324805|O2|Outcome|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679716|NCT00324805|O1|Outcome|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679717|NCT00324805|O2|Outcome|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679718|NCT00324805|O1|Outcome|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679719|NCT00324805|E2|Reported Event|Arm II (Chemotherapy, Bevacizumab)|"Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.~Bevacizumab: Given IV~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679765|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679766|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679767|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679768|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679769|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679720|NCT00324805|E1|Reported Event|Arm I (Chemotherapy)|"Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1~Cisplatin: Given IV~Docetaxel: Given IV~Gemcitabine Hydrochloride: Given IV~Pemetrexed Disodium: Given IV~Vinorelbine: Given IV"
679721|NCT00324740|B1|Baseline|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679722|NCT00324740|P3|Participant Flow|Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.5 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679723|NCT00324740|P2|Participant Flow|Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.375 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679724|NCT00324740|P1|Participant Flow|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.25 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679725|NCT00324740|O1|Outcome|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679726|NCT00324740|O3|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679727|NCT00324740|O2|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679728|NCT00324740|O1|Outcome|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679729|NCT00324740|E1|Reported Event|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
679730|NCT00324701|B3|Baseline|Total|Total of all reporting groups
679731|NCT00324701|B2|Baseline|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
679732|NCT00324701|B1|Baseline|Telepsychology|therapy done at patients house using in-home video conferencing technology
679733|NCT00324701|P2|Participant Flow|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
679734|NCT00324701|P1|Participant Flow|Telepsychology|therapy done at patients house using in-home video conferencing technology
679735|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
679736|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
679737|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
679738|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
679739|NCT00324701|E2|Reported Event|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
679740|NCT00324701|E1|Reported Event|Telepsychology|therapy done at patients house using in-home video conferencing technology
679741|NCT00324675|B3|Baseline|Total|Total of all reporting groups
679742|NCT00324675|B2|Baseline|Placebo|
679743|NCT00324675|B1|Baseline|Rosiglitazone|
679744|NCT00324675|P2|Participant Flow|Placebo|
679745|NCT00324675|P1|Participant Flow|Rosiglitazone|
679746|NCT00324675|O2|Outcome|Placebo|
679747|NCT00324675|O1|Outcome|Rosiglitazone|
679748|NCT00324675|E2|Reported Event|Placebo|
679749|NCT00324675|E1|Reported Event|Rosiglitazone|
679750|NCT00324649|B3|Baseline|Total|Total of all reporting groups
679751|NCT00324649|B2|Baseline|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679752|NCT00324649|B1|Baseline|Truvada|Truvada + NNRTI or PI.
679753|NCT00324649|P2|Participant Flow|Zidovudine/Lamivudine|Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
679754|NCT00324649|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
679755|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679756|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679757|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679758|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679759|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679760|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679761|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679762|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679781|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679782|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679783|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679784|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679785|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679786|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679787|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679788|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679789|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679790|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
679791|NCT00324649|E2|Reported Event|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
679792|NCT00324649|E1|Reported Event|Truvada|Truvada + NNRTI or PI.
679793|NCT00324415|B1|Baseline|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
679794|NCT00324415|P1|Participant Flow|Combined Modality Therapy|Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab
679795|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
679796|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
679797|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
679798|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
679799|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
679800|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
679801|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
679802|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
679803|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
679804|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
679805|NCT00324415|E1|Reported Event|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
679806|NCT00324350|B3|Baseline|Total|Total of all reporting groups
679807|NCT00324350|B2|Baseline|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679808|NCT00324350|B1|Baseline|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679809|NCT00324350|P2|Participant Flow|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679810|NCT00324350|P1|Participant Flow|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679811|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679812|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679813|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679814|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%) in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679815|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679816|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679817|NCT00324350|E2|Reported Event|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679818|NCT00324350|E1|Reported Event|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
679819|NCT00324272|B5|Baseline|Total|Total of all reporting groups
679820|NCT00324272|B4|Baseline|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679889|NCT00324233|E2|Reported Event|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
679890|NCT00324233|E1|Reported Event|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
679891|NCT00324168|B3|Baseline|Total|Total of all reporting groups
679821|NCT00324272|B3|Baseline|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679822|NCT00324272|B2|Baseline|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679823|NCT00324272|B1|Baseline|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679824|NCT00324272|P4|Participant Flow|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679825|NCT00324272|P3|Participant Flow|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679826|NCT00324272|P2|Participant Flow|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679827|NCT00324272|P1|Participant Flow|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679828|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679829|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679830|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679831|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679832|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679833|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679834|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679835|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679836|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679837|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679838|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679839|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679840|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679841|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679842|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
680055|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
679843|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679844|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679845|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679846|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679847|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679848|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679849|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679850|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679851|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679852|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679853|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679854|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679855|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679856|NCT00324272|E4|Reported Event|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679857|NCT00324272|E3|Reported Event|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679858|NCT00324272|E2|Reported Event|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679859|NCT00324272|E1|Reported Event|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
679860|NCT00324259|B3|Baseline|Total|Total of all reporting groups
679861|NCT00324259|B2|Baseline|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679862|NCT00324259|B1|Baseline|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679863|NCT00324259|P2|Participant Flow|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679864|NCT00324259|P1|Participant Flow|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679865|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol) and Arm 2 (30 mg Estradiol)|"Arm 1 = 6 mg of estradiol daily (2 mg tid).~Arm 2 = 30 mg of estradiol. (10 mg tid)"
679866|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679867|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679868|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679869|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679870|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679871|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679872|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679873|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679874|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679875|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679876|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679877|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679878|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679879|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679880|NCT00324259|E2|Reported Event|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
679881|NCT00324259|E1|Reported Event|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
679882|NCT00324233|B3|Baseline|Total|Total of all reporting groups
679883|NCT00324233|B2|Baseline|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
679884|NCT00324233|B1|Baseline|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
679885|NCT00324233|P2|Participant Flow|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
679886|NCT00324233|P1|Participant Flow|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
679887|NCT00324233|O2|Outcome|SpediCath Compact Male|
679888|NCT00324233|O1|Outcome|SpeediCath|
680076|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
679892|NCT00324168|B2|Baseline|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679893|NCT00324168|B1|Baseline|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679894|NCT00324168|P2|Participant Flow|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679895|NCT00324168|P1|Participant Flow|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679896|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679897|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679898|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679899|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679900|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679901|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679902|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679903|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679904|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679905|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679906|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679907|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679908|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679909|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679910|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679911|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679912|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679913|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679914|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679915|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679916|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
680072|NCT00323635|P2|Participant Flow|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
679917|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679918|NCT00324168|E2|Reported Event|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679919|NCT00324168|E1|Reported Event|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
679920|NCT00324155|B3|Baseline|Total|Total of all reporting groups
679921|NCT00324155|B2|Baseline|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679922|NCT00324155|B1|Baseline|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679923|NCT00324155|P2|Participant Flow|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679924|NCT00324155|P1|Participant Flow|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679925|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679926|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679927|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679928|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679929|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679930|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10m g/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679931|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679932|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679933|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
679934|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679935|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679936|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In maintenance phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679937|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679938|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression, (PD) unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679939|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679940|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679941|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
679942|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1e dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679943|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679944|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679945|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
679946|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
680056|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680077|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
679947|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679948|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679949|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
679950|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
679951|NCT00324155|E2|Reported Event|Placebo + Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679952|NCT00324155|E1|Reported Event|10 mg/kg Ipilimumab + Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 wks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
679953|NCT00324116|B1|Baseline|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679954|NCT00324116|P1|Participant Flow|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679955|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679956|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679957|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679958|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679959|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679960|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679961|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679962|NCT00324116|E1|Reported Event|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
679963|NCT00324038|B3|Baseline|Total|Total of all reporting groups
679964|NCT00324038|B2|Baseline|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
679965|NCT00324038|B1|Baseline|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
679966|NCT00324038|P2|Participant Flow|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
679967|NCT00324038|P1|Participant Flow|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
679968|NCT00324038|O2|Outcome|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
679969|NCT00324038|O1|Outcome|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
679970|NCT00324038|E2|Reported Event|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
679971|NCT00324038|E1|Reported Event|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
679972|NCT00323882|B6|Baseline|Total|Total of all reporting groups
680057|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680058|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680059|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
679973|NCT00323882|B5|Baseline|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679974|NCT00323882|B4|Baseline|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679975|NCT00323882|B3|Baseline|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679976|NCT00323882|B2|Baseline|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679977|NCT00323882|B1|Baseline|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679978|NCT00323882|P5|Participant Flow|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679979|NCT00323882|P4|Participant Flow|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to Response Evaluation Criteria in Solid Tumors (RECIST), target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679980|NCT00323882|P3|Participant Flow|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679981|NCT00323882|P2|Participant Flow|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses (maintenance). The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679982|NCT00323882|P1|Participant Flow|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of the induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680060|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680073|NCT00323635|P1|Participant Flow|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
679983|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679984|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679985|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679986|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679987|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679988|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679989|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679990|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679991|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679992|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680061|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680062|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680078|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
679993|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679994|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679995|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679996|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679997|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679998|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
679999|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680000|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680001|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680002|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680003|NCT00323882|O6|Outcome|All Treated Participants|All treatment groups are combined to show total overall survival at completion of Follow Up.
680063|NCT00323869|E1|Reported Event|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680074|NCT00323635|O2|Outcome|Placebo|"A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine~tolterodine: tablet, 4 mg, daily, 1 month"
680004|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680005|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680006|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680007|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680008|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680009|NCT00323882|O6|Outcome|All Treated Participants|All participants in all treatment arms combined.
680010|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680011|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680012|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680013|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680014|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680064|NCT00323739|B1|Baseline|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
680015|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680016|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680017|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680018|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680019|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680020|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants with no prior chemotherapy, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680021|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680022|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680023|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants who had received no chemotherapy prior to the study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680065|NCT00323739|P1|Participant Flow|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
680024|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680025|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680026|NCT00323882|O6|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680027|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680028|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680029|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680030|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680031|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680032|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680066|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
680075|NCT00323635|O1|Outcome|Tolterodine|"Tolterodine 4 mg q.d. X 8 weeks~tolterodine: tablet, 4 mg, daily, 1 month"
680033|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680034|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680035|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680036|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680037|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680038|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680039|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680040|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680041|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680042|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680067|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
680068|NCT00323739|E1|Reported Event|Bevacizumab + Everolimus|
680069|NCT00323635|B3|Baseline|Total|Total of all reporting groups
680043|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680044|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680045|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680046|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680047|NCT00323882|E5|Reported Event|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680048|NCT00323882|E4|Reported Event|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680049|NCT00323882|E3|Reported Event|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680050|NCT00323882|E2|Reported Event|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680051|NCT00323882|E1|Reported Event|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
680052|NCT00323869|B1|Baseline|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680053|NCT00323869|P1|Participant Flow|Bevacizumab + Carboplatin + Gemcitabine|"Bevacizumab in combination with carboplatin and gemcitabine~Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity Gemcitabine, administered 1000 mg/m2 IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles~Carboplatin was administered before gemcitabine infusion.~Bevacizumab was administered 1 hour after end of all chemotherapy infusions.~Bevacizumab: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody~Gemcitabine: Nucleoside analog~Carboplatin: Alkylating agent"
680054|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
680070|NCT00323635|B2|Baseline|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
680080|NCT00323635|O2|Outcome|Placebo|"A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine~tolterodine: tablet, 4 mg, daily, 1 month"
680081|NCT00323635|O1|Outcome|Tolterodine|"Tolterodine 4 mg q.d. X 8 weeks~tolterodine: tablet, 4 mg, daily, 1 month"
680082|NCT00323635|O2|Outcome|Placebo|"A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine~tolterodine: tablet, 4 mg, daily, 1 month"
680083|NCT00323635|O1|Outcome|Tolterodine|"Tolterodine 4 mg q.d. X 8 weeks~tolterodine: tablet, 4 mg, daily, 1 month"
680084|NCT00323635|O2|Outcome|Placebo|"A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine~tolterodine: tablet, 4 mg, daily, 1 month"
680085|NCT00323635|O1|Outcome|Tolterodine|"Tolterodine 4 mg q.d. X 8 weeks~tolterodine: tablet, 4 mg, daily, 1 month"
680086|NCT00323635|O2|Outcome|Placebo|"A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine~tolterodine: tablet, 4 mg, daily, 1 month"
680087|NCT00323635|O1|Outcome|Tolterodine|"Tolterodine 4 mg q.d. X 8 weeks~tolterodine: tablet, 4 mg, daily, 1 month"
680088|NCT00323635|O2|Outcome|Placebo|"A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine~tolterodine: tablet, 4 mg, daily, 1 month"
680089|NCT00323635|O1|Outcome|Tolterodine|"Tolterodine 4 mg q.d. X 8 weeks~tolterodine: tablet, 4 mg, daily, 1 month"
680090|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
680091|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
680092|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
680093|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
680094|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
680095|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
680096|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
680097|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
680098|NCT00323635|E2|Reported Event|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
680099|NCT00323635|E1|Reported Event|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
680100|NCT00323622|B9|Baseline|Total|Total of all reporting groups
680101|NCT00323622|B8|Baseline|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680102|NCT00323622|B7|Baseline|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680103|NCT00323622|B6|Baseline|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680104|NCT00323622|B5|Baseline|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680105|NCT00323622|B4|Baseline|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680106|NCT00323622|B3|Baseline|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680107|NCT00323622|B2|Baseline|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680158|NCT00323609|P4|Participant Flow|Vertebroplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
680108|NCT00323622|B1|Baseline|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680109|NCT00323622|P8|Participant Flow|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study
680110|NCT00323622|P7|Participant Flow|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680111|NCT00323622|P6|Participant Flow|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680112|NCT00323622|P5|Participant Flow|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680113|NCT00323622|P4|Participant Flow|Cohort 2-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680114|NCT00323622|P3|Participant Flow|Cohort 2-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680115|NCT00323622|P2|Participant Flow|Cohort 1-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680116|NCT00323622|P1|Participant Flow|Cohort 1-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection
680117|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680118|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680119|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680159|NCT00323609|P3|Participant Flow|Kyphoplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
680120|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680121|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680122|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680123|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680124|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680125|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680126|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680127|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680128|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680129|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680130|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680141|NCT00323622|O6|Outcome|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680131|NCT00323622|O4|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680132|NCT00323622|O3|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680133|NCT00323622|O2|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680134|NCT00323622|O1|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680135|NCT00323622|O4|Outcome|Cohort 2-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-Engerix-B ≥24M and Cohort 2-Prevnar-Hiberix <24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680136|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-RTS,S/AS02A <24M and Cohort 2-RTS,S/AS02A ≥24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680137|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
680138|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
680139|NCT00323622|O8|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680140|NCT00323622|O7|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680156|NCT00323609|B2|Baseline|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680157|NCT00323609|B1|Baseline|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680142|NCT00323622|O5|Outcome|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680143|NCT00323622|O4|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680144|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680145|NCT00323622|O2|Outcome|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680146|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680147|NCT00323622|E8|Reported Event|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680148|NCT00323622|E7|Reported Event|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680149|NCT00323622|E6|Reported Event|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680150|NCT00323622|E5|Reported Event|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680151|NCT00323622|E4|Reported Event|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680152|NCT00323622|E3|Reported Event|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
680153|NCT00323622|E2|Reported Event|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680154|NCT00323622|E1|Reported Event|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
680155|NCT00323609|B3|Baseline|Total|Total of all reporting groups
680160|NCT00323609|P2|Participant Flow|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680161|NCT00323609|P1|Participant Flow|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680162|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680163|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680164|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680165|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680166|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680167|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680168|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680169|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680170|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680171|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680172|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680173|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680174|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680175|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680176|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680177|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680178|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680179|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680180|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680181|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680182|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680183|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680184|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680185|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680186|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680187|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680188|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680189|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680190|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680191|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680192|NCT00323609|E2|Reported Event|Vertebroplasty|This group of patients has received vertebroplasty procedure.
680193|NCT00323609|E1|Reported Event|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
680194|NCT00323557|B3|Baseline|Total|Total of all reporting groups
680195|NCT00323557|B2|Baseline|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
680196|NCT00323557|B1|Baseline|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
680197|NCT00323557|P2|Participant Flow|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
680198|NCT00323557|P1|Participant Flow|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
680199|NCT00323557|O3|Outcome|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0. No CM-CSF.
680200|NCT00323557|O2|Outcome|Pneumococcal Vaccine + Post Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.
680201|NCT00323557|O1|Outcome|Pneumococcal Vaccine + Pre Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).
680202|NCT00323557|E2|Reported Event|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
680203|NCT00323557|E1|Reported Event|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
680204|NCT00323492|B3|Baseline|Total|Total of all reporting groups
680205|NCT00323492|B2|Baseline|Maintain Baseline Regimen|Maintain baseline regimen.
680206|NCT00323492|B1|Baseline|Truvada|Truvada + NNRTI or PI.
680207|NCT00323492|P3|Participant Flow|Delayed Truvada|Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).
680208|NCT00323492|P2|Participant Flow|Maintain Baseline Regimen|Maintain baseline regimen.
680209|NCT00323492|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
680210|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680211|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680212|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680213|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680214|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680215|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680216|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680217|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680218|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680219|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680220|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680221|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680222|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680223|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680224|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680225|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680226|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680227|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680228|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680229|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680230|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680231|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680232|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680233|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680234|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
680235|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
680236|NCT00323492|E3|Reported Event|All Truvada|"Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the maintain baseline regimen group in Study Phase 2)."
680237|NCT00323492|E2|Reported Event|Maintain Baseline Regimen|Maintain baseline regimen. The number of participants at risk is the number who started the study by maintaining their baseline regimen. Per protocol, participants in this group were allowed to switch to Truvada after Week 12 (Delayed TVD group), therefore the number of participants at risk declines over time (from 45 at baseline to 17 who completed Study Phase 2; with most participants switching to Truvada at Week 12).
680238|NCT00323492|E1|Reported Event|Truvada|Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2).
680239|NCT00323479|B1|Baseline|Anastrozole 1 mg|Anastrozole 1 mg once daily
680240|NCT00323479|P1|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg once daily
680241|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
680242|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
680243|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
680244|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
680245|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
680246|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
680247|NCT00323479|E1|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg once daily
680248|NCT00323427|B3|Baseline|Total|Total of all reporting groups
680249|NCT00323427|B2|Baseline|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
680250|NCT00323427|B1|Baseline|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
680251|NCT00323427|P2|Participant Flow|Hearing Aids|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
680252|NCT00323427|P1|Participant Flow|Group Aural Rehabilitation|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
680253|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
680254|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
680255|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
680256|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
680257|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
680258|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
680259|NCT00323427|E2|Reported Event|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
680260|NCT00323427|E1|Reported Event|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
680261|NCT00323414|B3|Baseline|Total|Total of all reporting groups
680262|NCT00323414|B2|Baseline|Placebo|Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
680263|NCT00323414|B1|Baseline|PUFA|Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
680264|NCT00323414|P2|Participant Flow|Placebo|Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
680265|NCT00323414|P1|Participant Flow|PUFA|Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
680266|NCT00323414|O2|Outcome|Placebo|Placebo arm of therapy
680267|NCT00323414|O1|Outcome|PUFA|Active treatment with PUFA
680268|NCT00323414|O2|Outcome|Placebo|Placebo arm of therapy
680269|NCT00323414|O1|Outcome|PUFA|Active treatment with PUFA
680270|NCT00323414|O2|Outcome|Placebo|Placebo arm of therapy
680271|NCT00323414|O1|Outcome|PUFA|Active treatment with PUFA
680272|NCT00323414|O2|Outcome|Placebo|Placebo arm of therapy
680278|NCT00323414|E2|Reported Event|Placebo|Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
680279|NCT00323414|E1|Reported Event|PUFA|Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks
680280|NCT00323362|B1|Baseline|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
680281|NCT00323362|P1|Participant Flow|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
680282|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
680283|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
680284|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
680285|NCT00323362|E1|Reported Event|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
680286|NCT00323310|B1|Baseline|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680287|NCT00323310|P1|Participant Flow|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680288|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680289|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680290|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680291|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680292|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680293|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680294|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680295|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680296|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680297|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680298|NCT00323310|E1|Reported Event|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
680299|NCT00323297|B3|Baseline|Total|Total of all reporting groups
680300|NCT00323297|B2|Baseline|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680301|NCT00323297|B1|Baseline|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
680302|NCT00323297|P2|Participant Flow|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680303|NCT00323297|P1|Participant Flow|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680304|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680305|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
680306|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680307|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
680308|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680309|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
680310|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680311|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
680312|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680313|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
680314|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680315|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
680316|NCT00323297|E2|Reported Event|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680317|NCT00323297|E1|Reported Event|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
680318|NCT00323284|B3|Baseline|Total|Total of all reporting groups
680319|NCT00323284|B2|Baseline|B--Cataract Surgery Only|Cataract Surgery only
680320|NCT00323284|B1|Baseline|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
680321|NCT00323284|P2|Participant Flow|B--Cataract Surgery Only|Cataract Surgery only
680322|NCT00323284|P1|Participant Flow|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
680323|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
680324|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
680325|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
680326|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
680327|NCT00323284|E2|Reported Event|B--Cataract Surgery Only|Cataract Surgery only
680328|NCT00323284|E1|Reported Event|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
680329|NCT00323271|B3|Baseline|Total|Total of all reporting groups
680330|NCT00323271|B2|Baseline|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
680331|NCT00323271|B1|Baseline|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
680332|NCT00323271|P2|Participant Flow|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
680333|NCT00323271|P1|Participant Flow|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
680334|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
680348|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
680335|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
680336|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
680337|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
680338|NCT00323271|E2|Reported Event|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
680339|NCT00323271|E1|Reported Event|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
680340|NCT00323258|B3|Baseline|Total|Total of all reporting groups
680341|NCT00323258|B2|Baseline|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
680342|NCT00323258|B1|Baseline|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
680343|NCT00323258|P2|Participant Flow|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
680344|NCT00323258|P1|Participant Flow|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
680345|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
680346|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
680347|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
680373|NCT00323063|B3|Baseline|Total|Total of all reporting groups
680349|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
680350|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
680351|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
680352|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
680353|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
680354|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
680355|NCT00323258|E2|Reported Event|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
680356|NCT00323258|E1|Reported Event|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
680357|NCT00323193|B3|Baseline|Total|Total of all reporting groups
680358|NCT00323193|B2|Baseline|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
680359|NCT00323193|B1|Baseline|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
680360|NCT00323193|P2|Participant Flow|Control Group|The control group offers basic information about diet and exercise every month for six months.
680361|NCT00323193|P1|Participant Flow|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
680362|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
680363|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
680364|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
680365|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
680366|NCT00323193|E2|Reported Event|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
680367|NCT00323193|E1|Reported Event|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
680368|NCT00323115|B1|Baseline|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
680369|NCT00323115|P1|Participant Flow|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
680370|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
680371|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
680372|NCT00323115|E1|Reported Event|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
680374|NCT00323063|B2|Baseline|Arm II|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
680375|NCT00323063|B1|Baseline|Arm I|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.~gemcitabine hydrochloride: Given IV"
680376|NCT00323063|P2|Participant Flow|Gemcitabine Hydrochloride + Imatinib|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
680377|NCT00323063|P1|Participant Flow|Gemcitabine Hydrochloride|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.~gemcitabine hydrochloride: Given IV"
680378|NCT00323063|O2|Outcome|Arm II (Gemcitabine Hydrochloride + Imatinib)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
680379|NCT00323063|O1|Outcome|Arm I (Gemcitabine Hydrochloride)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10.~gemcitabine hydrochloride: Given IV"
680380|NCT00323063|O2|Outcome|Arm II (Gemcitabine Hydrochloride + Imatinib)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
680381|NCT00323063|O1|Outcome|Arm I (Gemcitabine Hydrochloride)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10.~gemcitabine hydrochloride: Given IV"
680382|NCT00323063|O2|Outcome|Arm II (Gemcitabine Hydrochloride + Imatinib)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
680383|NCT00323063|O1|Outcome|Arm I (Gemcitabine Hydrochloride)|"Patients receive gemcitabine hydrochloride IV on days 3 and 10.~gemcitabine hydrochloride: Given IV"
680384|NCT00323063|E2|Reported Event|Arm II (Gemcitabine Hydrochloride + Imatinib)|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10 and oral imatinib mesylate 400 mg orally once daily on days 1-5 and 8-12.~gemcitabine hydrochloride: Given IV~imatinib mesylate: Given orally"
680385|NCT00323063|E1|Reported Event|Arm I (Gemcitabine Hydrochloride)|"Patients receive gemcitabine hydrochloride 1250 mg/m2 intravenously on days 3 and 10.~gemcitabine hydrochloride: Given IV"
680386|NCT00323037|B3|Baseline|Total|Total of all reporting groups
680387|NCT00323037|B2|Baseline|Coreg Controlled Release|
680388|NCT00323037|B1|Baseline|Coreg Immediate Release|
680389|NCT00323037|P2|Participant Flow|Coreg Controlled Release|
680390|NCT00323037|P1|Participant Flow|Coreg Immediate Release|
680391|NCT00323037|O2|Outcome|Coreg Controlled Release|
680392|NCT00323037|O1|Outcome|Coreg Immediate Release|
680393|NCT00322881|B1|Baseline|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
680394|NCT00322881|P1|Participant Flow|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
680395|NCT00322881|O1|Outcome|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
680396|NCT00322881|E1|Reported Event|Carboplatin/Paclitaxel|"Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)~Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)"
680397|NCT00322868|B1|Baseline|Pioglitazone (30 mg)|After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days
680398|NCT00322868|P1|Participant Flow|Pioglitazone (30 mg)|After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days
680399|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680400|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680401|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680402|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680403|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680404|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680405|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680406|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680407|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680408|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680409|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680410|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680411|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680412|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680413|NCT00322868|O2|Outcome|Post-Treatment|Results following 28 days of Pioglitazone (oral, 30mg, once daily)
680414|NCT00322868|O1|Outcome|Baseline|Results pre-Pioglitazone dosing
680415|NCT00322868|E1|Reported Event|Pioglitazone (30 mg)|After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally,30 mg, once daily for 28 days
680416|NCT00322855|B1|Baseline|Chart Review|patients diagnosed with soft tissue sarcoma
680417|NCT00322855|P1|Participant Flow|Chart Review|patients diagnosed with soft tissue sarcoma
680418|NCT00322855|O1|Outcome|Chart Review|patients diagnosed with soft tissue sarcoma
680419|NCT00322855|E1|Reported Event|Chart Review|patients diagnosed with soft tissue sarcoma
680420|NCT00322842|B3|Baseline|Total|Total of all reporting groups
680421|NCT00322842|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680422|NCT00322842|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680423|NCT00322842|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680424|NCT00322842|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680425|NCT00322842|O3|Outcome|All Participants|
680426|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680427|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680428|NCT00322842|O3|Outcome|All Participants|
680429|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680430|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680431|NCT00322842|O3|Outcome|All Participants|
680432|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680433|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680434|NCT00322842|O3|Outcome|All Participants|
680435|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680436|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680437|NCT00322842|O3|Outcome|All Participants|
680438|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680439|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680440|NCT00322842|O3|Outcome|All Participants|
680441|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680466|NCT00322621|P3|Participant Flow|Rescue Arm|Duloxetine: 120 milligrams once daily.
680442|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680443|NCT00322842|O3|Outcome|All Participants|
680444|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680445|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680446|NCT00322842|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680447|NCT00322842|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680448|NCT00322777|B3|Baseline|Total|Total of all reporting groups
680449|NCT00322777|B2|Baseline|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
680450|NCT00322777|B1|Baseline|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
680451|NCT00322777|P2|Participant Flow|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
680452|NCT00322777|P1|Participant Flow|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
680453|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
680454|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
680455|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
680456|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
680457|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
680458|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
680459|NCT00322777|E2|Reported Event|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
680460|NCT00322777|E1|Reported Event|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
680461|NCT00322712|B1|Baseline|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
680462|NCT00322712|P1|Participant Flow|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
680463|NCT00322712|O1|Outcome|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
680464|NCT00322712|E1|Reported Event|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
680465|NCT00322621|B1|Baseline|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
680467|NCT00322621|P2|Participant Flow|Maintenance Arm|Duloxetine: 60 milligrams once daily.
680468|NCT00322621|P1|Participant Flow|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months.
680469|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
680470|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
680471|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
680472|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
680473|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
680474|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
680475|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
680476|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
680477|NCT00322621|O4|Outcome|Rescue Arm|duloxetine 120 mg once daily
680478|NCT00322621|O3|Outcome|Maintenance Arm (Later Dose Increase)|duloxetine 60 mg once daily and then increasing to 120 mg once daily
680479|NCT00322621|O2|Outcome|Maintenance Arm (No Dose Increase)|duloxetine 60 mg once daily
680480|NCT00322621|O1|Outcome|All Maintenance / Rescue Participants|Total of the Maintenance (No Dose Increase), Maintenance (Later Dose Increase) and Rescue arms. Depending on the group the patient was in, they either received duloxetine 60 mg once daily; 60 mg once daily and then increased to 120 mg once daily; or 120 mg once daily.
680481|NCT00322621|O1|Outcome|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
680482|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680483|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680484|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680485|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680486|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680487|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680488|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680489|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680490|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680491|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680492|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680493|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680494|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680495|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680496|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680497|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680498|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680499|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680500|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680501|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680502|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680503|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680504|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680505|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680506|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680507|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680508|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680509|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680510|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680511|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680512|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680513|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680514|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
680515|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680516|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
680517|NCT00322621|E2|Reported Event|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
680518|NCT00322621|E1|Reported Event|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
680519|NCT00322556|B1|Baseline|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680520|NCT00322556|P1|Participant Flow|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680521|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680522|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680523|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680524|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680525|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680526|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680527|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680528|NCT00322556|O3|Outcome|IgPro10 (> 8 to ≤ 12 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (> 8 and ≤ 12 mg/kg/min) for old subjects.
680529|NCT00322556|O2|Outcome|IgPro10 (≤ 8 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.
680530|NCT00322556|O1|Outcome|IgPro10 (≤ 4 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the maximum infusion rate (≤ 4 mg/kg/min) for new subjects.
680531|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680532|NCT00322556|E1|Reported Event|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
680533|NCT00322491|B3|Baseline|Total|Total of all reporting groups
680534|NCT00322491|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680535|NCT00322491|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680536|NCT00322491|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680537|NCT00322491|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680538|NCT00322491|O3|Outcome|All Participants|
680539|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680540|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680541|NCT00322491|O3|Outcome|All Participants|
680542|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680543|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680544|NCT00322491|O3|Outcome|All Participants|
680545|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680546|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680547|NCT00322491|O3|Outcome|All Participants|
680575|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680661|NCT00322452|E2|Reported Event|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680548|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680549|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680550|NCT00322491|O3|Outcome|All Participants|
680551|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680552|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680553|NCT00322491|O3|Outcome|All Participants|
680554|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680555|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680556|NCT00322491|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680557|NCT00322491|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
680558|NCT00322465|B5|Baseline|Total|Total of all reporting groups
680559|NCT00322465|B4|Baseline|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680560|NCT00322465|B3|Baseline|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680561|NCT00322465|B2|Baseline|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680562|NCT00322465|B1|Baseline|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680563|NCT00322465|P4|Participant Flow|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680564|NCT00322465|P3|Participant Flow|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680565|NCT00322465|P2|Participant Flow|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680566|NCT00322465|P1|Participant Flow|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680567|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680568|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680569|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680570|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680571|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680572|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680573|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680574|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680662|NCT00322452|E1|Reported Event|Gefitinib|Gefitinib 250mg daily
680576|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680577|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680578|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680579|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680580|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680581|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680582|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680583|NCT00322465|O1|Outcome|All Participants Analyzed|
680584|NCT00322465|O1|Outcome|All Participants Analyzed|
680585|NCT00322465|O1|Outcome|All Participants Analyzed|
680586|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680587|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680588|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680589|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680590|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680591|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680592|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680593|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680594|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680595|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680596|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680597|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680598|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680599|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680600|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680601|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680602|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680603|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680604|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680605|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680606|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680607|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680608|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680609|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680610|NCT00322465|O2|Outcome|Azithromycin + (Azithromycin + Tinidazole)|Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
681036|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
680611|NCT00322465|O1|Outcome|Doxycycline + (Doxycycline + Tinidazole)|Doxycycline 100 mg PO BID (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin PO single dose and placebo tinidazole + (Doxycycline 100 mg PO BID for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm PO single dose (4 tablets at 500 mg each)).
680612|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680613|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680614|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680615|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680616|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680617|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680618|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680619|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680620|NCT00322465|E4|Reported Event|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
680621|NCT00322465|E3|Reported Event|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
680622|NCT00322465|E2|Reported Event|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
680623|NCT00322465|E1|Reported Event|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
680624|NCT00322452|B3|Baseline|Total|Total of all reporting groups
680625|NCT00322452|B2|Baseline|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680626|NCT00322452|B1|Baseline|Gefitinib|Gefitinib 250mg daily
680627|NCT00322452|P2|Participant Flow|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680628|NCT00322452|P1|Participant Flow|Gefitinib|Gefitinib 250mg daily
680629|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680630|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680631|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680632|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680633|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680634|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680635|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680636|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680637|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680638|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680639|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680640|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680641|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680642|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680643|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680644|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680645|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680646|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680647|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680648|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680649|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680650|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680651|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680652|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680653|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680654|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680655|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680656|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680657|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680658|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680659|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
680660|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
680663|NCT00322439|B1|Baseline|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680664|NCT00322439|P1|Participant Flow|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680665|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680666|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680667|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680668|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680669|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680670|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680671|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680672|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680673|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680674|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680675|NCT00322439|E1|Reported Event|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
680676|NCT00322387|B3|Baseline|Total|Total of all reporting groups
680677|NCT00322387|B2|Baseline|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
680678|NCT00322387|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
680679|NCT00322387|P2|Participant Flow|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
680680|NCT00322387|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
680729|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680730|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
681037|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
680681|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680682|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
680683|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680684|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680685|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680686|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680687|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680688|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680689|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
680690|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680691|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680731|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680732|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680692|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680693|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680694|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680695|NCT00322387|O8|Outcome|All Participants|
680696|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680697|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
680698|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680699|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680700|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680701|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680702|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680703|NCT00322387|E7|Reported Event|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680733|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680734|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680704|NCT00322387|E6|Reported Event|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|"Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen.~Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days."
680705|NCT00322387|E5|Reported Event|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680706|NCT00322387|E4|Reported Event|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680707|NCT00322387|E3|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
680708|NCT00322387|E2|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
680709|NCT00322387|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
680710|NCT00322374|B4|Baseline|Total|Total of all reporting groups
680711|NCT00322374|B3|Baseline|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680712|NCT00322374|B2|Baseline|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680713|NCT00322374|B1|Baseline|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680714|NCT00322374|P4|Participant Flow|All Participants|
680715|NCT00322374|P3|Participant Flow|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680716|NCT00322374|P2|Participant Flow|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680717|NCT00322374|P1|Participant Flow|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680718|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
680719|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
680720|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
680721|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
680722|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with measurable disease at baseline per RECIST
680723|NCT00322374|O1|Outcome|All Participants With Measurable Disease|Participants with measurable disease at baseline per RECIST
680724|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680725|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680726|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680727|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680728|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680735|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680736|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680737|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680738|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680739|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680740|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680741|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680742|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680743|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680744|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680745|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680746|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680747|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680748|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680749|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680750|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680751|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680752|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680753|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680754|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680755|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680756|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680757|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants received Ixabepilone administered as a 3-hour IV infusion following a 3- to 5-minute IV infusion of Epirubicin every 21 days.
680758|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680759|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680760|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680761|NCT00322374|E3|Reported Event|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680762|NCT00322374|E2|Reported Event|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680763|NCT00322374|E1|Reported Event|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
680764|NCT00322348|B3|Baseline|Total|Total of all reporting groups
680765|NCT00322348|B2|Baseline|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680766|NCT00322348|B1|Baseline|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680767|NCT00322348|P2|Participant Flow|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680768|NCT00322348|P1|Participant Flow|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680769|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680770|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680771|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680772|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680773|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680774|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680775|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680776|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680777|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680778|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680779|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680780|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680781|NCT00322348|E2|Reported Event|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
680782|NCT00322348|E1|Reported Event|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
680783|NCT00322335|B4|Baseline|Total|Total of all reporting groups
680784|NCT00322335|B3|Baseline|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680785|NCT00322335|B2|Baseline|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680786|NCT00322335|B1|Baseline|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680787|NCT00322335|P3|Participant Flow|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680788|NCT00322335|P2|Participant Flow|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680789|NCT00322335|P1|Participant Flow|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680790|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680791|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680838|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680839|NCT00322309|O2|Outcome|Placebo|Subjects received matched placebo capsules
680840|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680792|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680793|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680794|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680795|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680796|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680797|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680798|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680799|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680800|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680801|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680802|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680803|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680841|NCT00322309|E2|Reported Event|Placebo|Matched placebo
681038|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
680804|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680805|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680806|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680807|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680808|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680809|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680810|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680811|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680812|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680813|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680814|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680815|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680842|NCT00322309|E1|Reported Event|Mirtazapine Daily: Days 1-4 15mg Days 5-9 30mg Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680816|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680817|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680818|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680819|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680820|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680821|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680822|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680823|NCT00322335|E3|Reported Event|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
680824|NCT00322335|E2|Reported Event|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680825|NCT00322335|E1|Reported Event|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
680826|NCT00322309|B3|Baseline|Total|Total of all reporting groups
680827|NCT00322309|B2|Baseline|Placebo|Subjects received matched placebo capsules
680828|NCT00322309|B1|Baseline|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680829|NCT00322309|P2|Participant Flow|Placebo|Matched placebo given daily days 1-84
680830|NCT00322309|P1|Participant Flow|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680831|NCT00322309|O2|Outcome|Placebo|Matched placebo given daily days 1-84
680832|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680833|NCT00322309|O2|Outcome|Placebo|Matched placebo given daily days 1-84
680834|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680835|NCT00322309|O2|Outcome|Placebo|Matched placebo capsules
680836|NCT00322309|O1|Outcome|Mirtazepine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
680837|NCT00322309|O2|Outcome|Placebo|Subjects received matched placebo capsules
680843|NCT00322231|B3|Baseline|Total|Total of all reporting groups
680844|NCT00322231|B2|Baseline|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
680845|NCT00322231|B1|Baseline|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
680846|NCT00322231|P2|Participant Flow|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
680847|NCT00322231|P1|Participant Flow|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
680848|NCT00322231|O2|Outcome|Placebo|Participants included in this analysis were those who received Placebo in Placebo /ZOSTAVAX™ group (on Day 1). Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group were excluded in order to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
680849|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group are included. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
680850|NCT00322231|O2|Outcome|Placebo|Participants who received placebo (at Day 1) in Placebo / ZOSTAVAX™ group. Participants who received ZOSTAVAX™ at (Day 1) in the ZOSTAVAX™ / Placebo group were excluded to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements.
680851|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included.
680852|NCT00322231|O2|Outcome|Placebo|Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
680853|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
680854|NCT00322231|E2|Reported Event|Placebo|All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis.
680855|NCT00322231|E1|Reported Event|ZOSTAVAX™|All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis.
680856|NCT00322153|B3|Baseline|Total|Total of all reporting groups
680857|NCT00322153|B2|Baseline|Memantine ER|28mg once daily oral administration for 24 weeks.
680858|NCT00322153|B1|Baseline|Placebo|Matching placebo oral administration once daily for 24 weeks.
680859|NCT00322153|P2|Participant Flow|Memantine ER|28mg once daily oral administration for 24 weeks.
680860|NCT00322153|P1|Participant Flow|Placebo|Matching placebo oral administration once daily for 24 weeks.
680861|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
680862|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
680863|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
680864|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
680865|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
680866|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
680867|NCT00322153|E2|Reported Event|Memantine ER|28mg once daily oral administration for 24 weeks.
680868|NCT00322153|E1|Reported Event|Placebo|Matching placebo oral administration once daily for 24 weeks.
680869|NCT00322101|B3|Baseline|Total|Total of all reporting groups
680870|NCT00322101|B2|Baseline|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680871|NCT00322101|B1|Baseline|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680872|NCT00322101|P2|Participant Flow|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680873|NCT00322101|P1|Participant Flow|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
681039|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
680874|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680875|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680876|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680877|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680878|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680879|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680880|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680881|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680882|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680883|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680884|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680917|NCT00322049|O1|Outcome|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680918|NCT00322049|O3|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
681040|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
681041|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
680885|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680886|NCT00322101|E2|Reported Event|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
680887|NCT00322101|E1|Reported Event|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
680888|NCT00322049|B5|Baseline|Total|Total of all reporting groups
680889|NCT00322049|B4|Baseline|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680890|NCT00322049|B3|Baseline|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680891|NCT00322049|B2|Baseline|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680892|NCT00322049|B1|Baseline|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680893|NCT00322049|P4|Participant Flow|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680894|NCT00322049|P3|Participant Flow|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680895|NCT00322049|P2|Participant Flow|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680896|NCT00322049|P1|Participant Flow|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680897|NCT00322049|O2|Outcome|Subject With Viremia Measured by: Nested PCR|Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia
680898|NCT00322049|O1|Outcome|Subject With Viremia Measured by: RT-PCR|Scheduled phlebotomy and unscheduled phlebotomy when a subject was ill during the study revealed dengue viremia
680899|NCT00322049|O5|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
680900|NCT00322049|O4|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680901|NCT00322049|O3|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680902|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680903|NCT00322049|O1|Outcome|Control Group|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680904|NCT00322049|O3|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680905|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680906|NCT00322049|O1|Outcome|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680907|NCT00322049|O4|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
680908|NCT00322049|O3|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680909|NCT00322049|O2|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680910|NCT00322049|O1|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680911|NCT00322049|O4|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full dose dengue vaccine at study months 0 and 6
680912|NCT00322049|O3|Outcome|Cohort C - Full Dose Dengue Vaccine|Full-dose dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680913|NCT00322049|O2|Outcome|Cohort B - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680914|NCT00322049|O1|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680915|NCT00322049|O3|Outcome|Cohorts B & C - Full Dose Dengue Vaccine|Full-dose of dengue vaccine at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680916|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680919|NCT00322049|O2|Outcome|Cohort A - 1/10th Dose Dengue Vaccine|1/10th full dose at study months 0 and 6 or control vaccines (varicells vaccine at study month 0 and Hib vaccine at study month 6)
680920|NCT00322049|O1|Outcome|Control Group - Hib Vaccine|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680921|NCT00322049|E4|Reported Event|Control Group|Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680922|NCT00322049|E3|Reported Event|Cohort C: Dengue Vaccine - Full Dose (T-DEN F17 )|Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years
680923|NCT00322049|E2|Reported Event|Cohort B: Full Dose (T-DEN F17 )|Control vaccines: Hemophilus influenza type b (Hib) vaccine and varicella vaccine
680924|NCT00322049|E1|Reported Event|Cohort A: Dengue Vaccine- 1/10 Dose (T-DEN F17 )|Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years;
680925|NCT00321984|B4|Baseline|Total|Total of all reporting groups
680926|NCT00321984|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
680927|NCT00321984|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
680928|NCT00321984|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
680929|NCT00321984|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
680930|NCT00321984|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
680931|NCT00321984|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
680932|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
680933|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
680934|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
680935|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
680936|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
680937|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
680938|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
680939|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
680940|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
680941|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
680942|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
680943|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
680944|NCT00321984|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
680945|NCT00321984|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
680946|NCT00321984|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
680947|NCT00321971|B3|Baseline|Total|Total of all reporting groups
680948|NCT00321971|B2|Baseline|Nutritional Training (NT)|"The comparison Intervention (Nutritional Training (NT-MCI/AD caregiving) was based on the United States Department of Health and Human Services (USDHHS) 2005 My Pyramid Dietary Guidelines for Americans over Age 50. We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions. Participants were asked to keep a record of menu planning, eating habits between session, and any questions they had related to the application of NT. These records were used as a basis for discussion during both phases of the intervention"
680949|NCT00321971|B1|Baseline|Problem Solving Training (PST)|The experimental Intervention focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressors. During the first session, participants received written and verbal education about the family caregiving role, the link between problems, overwhelming stress, symptoms of depression or anxiety, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST. Participants were asked to keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during both phases of the intervention.
680950|NCT00321971|P2|Participant Flow|NT-MCI/AD Caregiving|"The comparison Intervention (Nutritional Training (NT-MCI/AD caregiving) was based on the United States Department of Health and Human Services (USDHHS) 2005 My Pyramid Dietary Guidelines for Americans over Age 50. We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions."
680951|NCT00321971|P1|Participant Flow|PST-AD/MCI Caregiving|The experimental Intervention focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressors. During the first session, participants received written and verbal education about the family caregiving role, the link between problems, overwhelming stress, symptoms of depression or anxiety, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST. Participants were asked to keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during both phases of the intervention.
680973|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680952|NCT00321971|O2|Outcome|Nutritional Intervention|"The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) was based on the United States Department of Health and Human Services (USDHHS) 2005 My Pyramid Dietary Guidelines for Americans over Age 50. We chose a nutrition-based comparison intervention because information about dietary practices is not likely to affect mental health outcomes. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.~Nutritional education program: The nutritional education program will be based on the new USDA dietary recommendations. All participants attend weekly individual training sessions, either in their home or another convenient location for a total of 6 weeks."
680953|NCT00321971|O1|Outcome|Problem Solving Intervention|"The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). It was adapted from the work of Areán and colleagues, who developed a manualized protocol for PST use in primary care. Our adaptation sought to enhance problem-solving skill levels of family caregivers as they began to face a variety of potential caregiving stressor.~Problem-solving therapy: The self-management intervention will train participants to effectively use problem-solving skills with the aim of strengthening their ability to cope and preventing the onset or worsening of depressive and anxiety disorders. All participants attend weekly individual training sessions, either in their home, another convenient location, or by telephone for a total of 9 weeks."
680954|NCT00321971|E2|Reported Event|Comparison/Control Intervention|"The comparison Intervention (Caregiver Nutritional Training (NT-MCI/AD) was based on the USDHHS My Pyramid Dietary Guidelines for Americans over Age 50. The NT intervention was matched to the PST-based intervention in terms of number and duration of sessions.~During the first session, participants received written and verbal education about the structure of the sessions, MCI or dementia, and an overview of USDA Dietary Guidelines. Participants also completed a questionnaire about their current eating practices and activity level. In subsequent training sessions, the interventionist provided education related to the major food categories, discretionary calories, and tips and resources for menu planning. Participants were asked to keep a record of menu planning, eating habits between session, and any questions they had related to the application of NT. These records were used as a basis for discussion during both phases of the intervention."
680955|NCT00321971|E1|Reported Event|Experimental Intervention|"The experimental Intervention (PST-MCI/AD Caregiving) focuses on training in adaptive problem-solving attitudes and skills (Problem-Solving Therapy or PST). Participants received 2 phases of treatment; the first phase involved 6 sessions conducted in the caregiver’s home approximately 2 weeks apart, each lasting approximately 1.5 hours. The second phase included three telephone contacts (approximately 2 weeks apart) to reinforce principles taught during the first phase, each lasting approximately 45 minutes.~During the first session, participants received written and verbal education about the structure of sessions, MCI or dementia and the family caregiving role, the link between problems, overwhelming stress, and symptoms of depression, the relationship between low mood and reduced pleasurable activities, and the rationale for problem-solving training. In subsequent sessions, participants received written instructions and coaching in the systematic application of PST."
680956|NCT00321932|B3|Baseline|Total|Total of all reporting groups
680957|NCT00321932|B2|Baseline|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680958|NCT00321932|B1|Baseline|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680959|NCT00321932|P2|Participant Flow|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680960|NCT00321932|P1|Participant Flow|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680961|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680962|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680963|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680964|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680965|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680966|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680967|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680968|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680969|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680970|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680971|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680972|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680974|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680975|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV)( over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680976|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680977|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680978|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680979|NCT00321932|E2|Reported Event|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
680980|NCT00321932|E1|Reported Event|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
680981|NCT00321919|B3|Baseline|Total|Total of all reporting groups
680982|NCT00321919|B2|Baseline|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680983|NCT00321919|B1|Baseline|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680984|NCT00321919|P2|Participant Flow|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL has occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680985|NCT00321919|P1|Participant Flow|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hemoglobin (Hb) level of 13-15 gram/decilitre (g/dL) with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680986|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680987|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680988|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680989|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680990|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680991|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680992|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680993|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680994|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680995|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680996|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680997|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
680998|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
680999|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681000|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681001|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681034|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
681002|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681003|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681004|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681005|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months
681006|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681007|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681008|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681009|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681010|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681011|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681012|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681013|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681014|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681015|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681016|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681017|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681018|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681019|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681020|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681021|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681022|NCT00321919|E2|Reported Event|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
681023|NCT00321919|E1|Reported Event|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
681024|NCT00321906|B3|Baseline|Total|Total of all reporting groups
681025|NCT00321906|B2|Baseline|Sirolimus|tacrolimus/sirolimus/prednisone
681026|NCT00321906|B1|Baseline|Azathioprine|(tacrolimus,azathioprine/prednisone)
681027|NCT00321906|P2|Participant Flow|Sirolimus|tacrolimus/sirolimus/prednisone
681028|NCT00321906|P1|Participant Flow|Azathioprine|(tacrolimus,azathioprine/prednisone)
681029|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
681030|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
681031|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
681032|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
681033|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
681042|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
681043|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
681044|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
681045|NCT00321906|E2|Reported Event|Sirolimus|tacrolimus/sirolimus/prednisone
681046|NCT00321906|E1|Reported Event|Azathioprine|(tacrolimus,azathioprine/prednisone)
681047|NCT00321893|B3|Baseline|Total|Total of all reporting groups
681048|NCT00321893|B2|Baseline|Arm II: Placebo|Inhaled placebo twice daily for 1 year
681049|NCT00321893|B1|Baseline|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
681050|NCT00321893|P2|Participant Flow|Arm II: Placebo|Inhaled placebo twice daily for 1 year
681051|NCT00321893|P1|Participant Flow|Arm I: Budesonide|Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
681052|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
681053|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
681054|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
681055|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
681056|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
681057|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
681058|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
681059|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
681060|NCT00321893|E2|Reported Event|Arm II: Placebo|Inhaled placebo twice daily for 1 year
681061|NCT00321893|E1|Reported Event|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
681062|NCT00321854|B3|Baseline|Total|Total of all reporting groups
681063|NCT00321854|B2|Baseline|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681064|NCT00321854|B1|Baseline|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681065|NCT00321854|P2|Participant Flow|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
681066|NCT00321854|P1|Participant Flow|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
681067|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
681068|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
681069|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
681070|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
681071|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
681072|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
681073|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
681074|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
681075|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681076|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681077|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681078|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681079|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681080|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681081|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681082|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681083|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681084|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681085|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681086|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681087|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681088|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681089|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681090|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681091|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681092|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681093|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681094|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681095|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681096|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681097|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681098|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681099|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681100|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681101|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681102|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681103|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681104|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681105|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681106|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681107|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681108|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681109|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681110|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681111|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681112|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681113|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681114|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681115|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681116|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681117|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681118|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681119|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681120|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681121|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681122|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681123|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681124|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681125|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681126|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681127|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681128|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681129|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681130|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681131|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681132|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681133|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681134|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681135|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681136|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681137|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681138|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
682058|NCT00320190|E2|Reported Event|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily
681139|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681140|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681141|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681142|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681143|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681144|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681145|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681146|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681147|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681148|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681149|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681150|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681151|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681152|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681153|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681154|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681155|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681156|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681157|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681158|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681159|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681160|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681161|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681162|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681163|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681164|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681165|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681166|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681167|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681168|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681169|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681170|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681171|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681172|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681173|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681174|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681175|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681176|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681177|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681178|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681179|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681180|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681181|NCT00321854|E2|Reported Event|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
681182|NCT00321854|E1|Reported Event|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
681183|NCT00321828|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
681184|NCT00321828|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
681185|NCT00321828|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
681186|NCT00321828|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
681187|NCT00321789|B3|Baseline|Total|Total of all reporting groups
681188|NCT00321789|B2|Baseline|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681233|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681189|NCT00321789|B1|Baseline|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681190|NCT00321789|P2|Participant Flow|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681191|NCT00321789|P1|Participant Flow|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681192|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681193|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681194|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681195|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681196|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681197|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681198|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681199|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681200|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681201|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681202|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681203|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681204|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681205|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681206|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681207|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681208|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681234|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681209|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681210|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681211|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681212|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681213|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681214|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681215|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681216|NCT00321789|E2|Reported Event|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
681217|NCT00321789|E1|Reported Event|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
681218|NCT00321763|B5|Baseline|Total|Total of all reporting groups
681219|NCT00321763|B4|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681220|NCT00321763|B3|Baseline|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681221|NCT00321763|B2|Baseline|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681222|NCT00321763|B1|Baseline|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681223|NCT00321763|P4|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681224|NCT00321763|P3|Participant Flow|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681225|NCT00321763|P2|Participant Flow|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681226|NCT00321763|P1|Participant Flow|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681227|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681228|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681229|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681230|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681231|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681232|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681235|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681236|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681237|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681238|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681239|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681240|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681241|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681242|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681243|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681244|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681245|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681246|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681247|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681248|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681249|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681250|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681251|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681252|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681253|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681254|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681255|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681256|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681257|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681258|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681259|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681290|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681291|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681260|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681261|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681262|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681263|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681264|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681265|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681266|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681267|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681268|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681269|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681270|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681271|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681272|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681273|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681274|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681275|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681276|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681277|NCT00321763|E5|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681278|NCT00321763|E4|Reported Event|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
681279|NCT00321763|E3|Reported Event|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681280|NCT00321763|E2|Reported Event|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681281|NCT00321763|E1|Reported Event|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
681282|NCT00321737|B4|Baseline|Total|Total of all reporting groups
681283|NCT00321737|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681284|NCT00321737|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681285|NCT00321737|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681286|NCT00321737|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681287|NCT00321737|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681288|NCT00321737|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681289|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681292|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681293|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681294|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681295|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681296|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681297|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681298|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681299|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681300|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681301|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681302|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681303|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681304|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681305|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681306|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681307|NCT00321737|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
681308|NCT00321737|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
681309|NCT00321737|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
681310|NCT00321711|B6|Baseline|Total|Total of all reporting groups
681311|NCT00321711|B5|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681312|NCT00321711|B4|Baseline|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681313|NCT00321711|B3|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681314|NCT00321711|B2|Baseline|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681315|NCT00321711|B1|Baseline|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681316|NCT00321711|P5|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681317|NCT00321711|P4|Participant Flow|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681318|NCT00321711|P3|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681319|NCT00321711|P2|Participant Flow|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681320|NCT00321711|P1|Participant Flow|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681321|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681322|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681323|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681324|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681325|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681326|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681327|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681328|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681329|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681330|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681331|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681332|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681333|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681334|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681335|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681336|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681337|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
681338|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681339|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681340|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
681341|NCT00321711|E5|Reported Event|Part B Romiplostim 750 µg|
681342|NCT00321711|E4|Reported Event|Part B Placebo|
681343|NCT00321711|E3|Reported Event|Part A Romiplostim 750 µg|
681344|NCT00321711|E2|Reported Event|Part A Romiplostim 500 µg|
681345|NCT00321711|E1|Reported Event|Part A Placebo|
681346|NCT00321698|B6|Baseline|Total|Total of all reporting groups
681347|NCT00321698|B5|Baseline|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681348|NCT00321698|B4|Baseline|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681349|NCT00321698|B3|Baseline|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681350|NCT00321698|B2|Baseline|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681351|NCT00321698|B1|Baseline|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681352|NCT00321698|P5|Participant Flow|Phase II, MTD Dose|"MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681353|NCT00321698|P4|Participant Flow|Phase I, Dose 3|"Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
681354|NCT00321698|P3|Participant Flow|Phase I, Dose 2|"Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
681355|NCT00321698|P2|Participant Flow|Phase I, Dose 1|"Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
681356|NCT00321698|P1|Participant Flow|Phase I, Radiation Only|"Group 1=radiation only;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681357|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
681878|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
681358|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
681359|NCT00321698|O2|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681360|NCT00321698|O1|Outcome|Phase I Dose 1-4|"Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681361|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
681362|NCT00321698|O1|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681363|NCT00321698|O1|Outcome|Phase I Dose 1-4|"4 groups of men in phase I study.~Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation."
681364|NCT00321698|E5|Reported Event|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681365|NCT00321698|E4|Reported Event|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681366|NCT00321698|E3|Reported Event|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681367|NCT00321698|E2|Reported Event|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681368|NCT00321698|E1|Reported Event|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
681369|NCT00321685|B1|Baseline|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
681370|NCT00321685|P1|Participant Flow|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.~radiation therapy: Patients undergo 3-dimensional conformal radiation therapy once daily 5 days"
681371|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
681372|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
681373|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
681374|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
681375|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
681376|NCT00321685|E1|Reported Event|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
681377|NCT00321672|B5|Baseline|Total|Total of all reporting groups
681378|NCT00321672|B4|Baseline|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681379|NCT00321672|B3|Baseline|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
681380|NCT00321672|B2|Baseline|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681381|NCT00321672|B1|Baseline|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
681382|NCT00321672|P4|Participant Flow|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681383|NCT00321672|P3|Participant Flow|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
681384|NCT00321672|P2|Participant Flow|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681385|NCT00321672|P1|Participant Flow|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
681386|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681387|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
681388|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681389|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
681390|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681391|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
681392|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681393|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
681394|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681395|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
681396|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681397|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
681398|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681399|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
681400|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681401|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
681402|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681403|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
681404|NCT00321672|E6|Reported Event|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681405|NCT00321672|E5|Reported Event|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
681533|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
681534|NCT00320788|O6|Outcome|Total|
681406|NCT00321672|E4|Reported Event|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681407|NCT00321672|E3|Reported Event|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
681408|NCT00321672|E2|Reported Event|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
681409|NCT00321672|E1|Reported Event|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
681410|NCT00321646|B1|Baseline|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
681411|NCT00321646|P1|Participant Flow|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
681412|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
681413|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
681414|NCT00321646|E1|Reported Event|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
681415|NCT00321620|B3|Baseline|Total|Total of all reporting groups
681416|NCT00321620|B2|Baseline|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
681417|NCT00321620|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
681418|NCT00321620|P2|Participant Flow|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
681419|NCT00321620|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
681420|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
681421|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
681422|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
681423|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
681424|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
681425|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
681426|NCT00321620|E2|Reported Event|Denosumab 120 mg Q4W|
681427|NCT00321620|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
681428|NCT00321594|B3|Baseline|Total|Total of all reporting groups
681429|NCT00321594|B2|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV Dose: 1400mg/m2/day"
681535|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
681430|NCT00321594|B1|Baseline|Phase I|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV Level 1: Dose: 600mg/m2/day Level 2: Dose: 900mg/m2/day Level 3: Dose: 1200mg/m2/day"
681431|NCT00321594|P5|Participant Flow|Phase II, MTD Dose|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 1400 mg/m2/day"
681432|NCT00321594|P4|Participant Flow|Phase I, Level 4|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 1400 mg/m2/day"
681433|NCT00321594|P3|Participant Flow|Phase I, Level 3|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 1200 mg/m2/day"
681434|NCT00321594|P2|Participant Flow|Phase I, Level 2|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 900 mg/m2/day"
681435|NCT00321594|P1|Participant Flow|Phase I, Level 1|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose level: 600 mg/m2/day"
681436|NCT00321594|O1|Outcome|Phase II, MTD|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1400mg/m2/day"
681437|NCT00321594|O4|Outcome|Phase I, Level 4|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1400mg/m2/day"
681438|NCT00321594|O3|Outcome|Phase I, Level 3|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1200mg/m2/day"
681439|NCT00321594|O2|Outcome|Phase I, Level 2|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 900 mg/m2/day"
681440|NCT00321594|O1|Outcome|Phase I, Level 1|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 600 mg/m2/day"
681441|NCT00321594|E5|Reported Event|Phase II, MTD|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1400mg/m2/day"
681442|NCT00321594|E4|Reported Event|Phase I, Level 4|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 600 to 1400mg/m2/day"
681443|NCT00321594|E3|Reported Event|Phase I, Level 3|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 1200mg/m2/day"
681444|NCT00321594|E2|Reported Event|Phase 1, Level 2|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 900mg/m2/day"
681445|NCT00321594|E1|Reported Event|Phase I, Level 1|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~Dose: 600 mg/m2/day"
681446|NCT00321464|B3|Baseline|Total|Total of all reporting groups
681447|NCT00321464|B2|Baseline|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
681448|NCT00321464|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
681449|NCT00321464|P2|Participant Flow|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
681450|NCT00321464|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
681451|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
681452|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
681453|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
681454|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
681455|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
681456|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
681457|NCT00321464|E2|Reported Event|Denosumab 120 mg Q4W|
681458|NCT00321464|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
681459|NCT00321373|B4|Baseline|Total|Total of all reporting groups
681460|NCT00321373|B3|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681461|NCT00321373|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681462|NCT00321373|B1|Baseline|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681463|NCT00321373|P3|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681464|NCT00321373|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681465|NCT00321373|P1|Participant Flow|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681466|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681467|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681468|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681469|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681470|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681471|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681472|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681473|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681474|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681475|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681476|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681477|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681478|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681479|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681480|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681481|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681482|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681483|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681484|NCT00321373|E3|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681485|NCT00321373|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681486|NCT00321373|E1|Reported Event|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
681487|NCT00321321|B1|Baseline|Sulfonylurea|
681488|NCT00321321|P1|Participant Flow|Sulfonylurea|
681489|NCT00321321|O1|Outcome|Sulfonylurea|
681490|NCT00321321|E1|Reported Event|Sulfonylurea|Sulfonylurea-treated patients
681491|NCT00321269|B3|Baseline|Total|Total of all reporting groups
681492|NCT00321269|B2|Baseline|8-Week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
681493|NCT00321269|B1|Baseline|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
681494|NCT00321269|P2|Participant Flow|8-week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
681536|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
681495|NCT00321269|P1|Participant Flow|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
681496|NCT00321269|O2|Outcome|8-Week Phone-Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
681497|NCT00321269|O1|Outcome|8-Week Phone-Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
681498|NCT00321269|O2|Outcome|8-week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
681499|NCT00321269|O1|Outcome|8-week Phone-based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
681500|NCT00321269|E2|Reported Event|8-Week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
681501|NCT00321269|E1|Reported Event|8-week Telephone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
681502|NCT00320801|B3|Baseline|Total|Total of all reporting groups
681503|NCT00320801|B2|Baseline|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
681504|NCT00320801|B1|Baseline|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
681505|NCT00320801|P4|Participant Flow|Extension Phase|Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
681506|NCT00320801|P3|Participant Flow|Double-blind BTDS 20|Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
681507|NCT00320801|P2|Participant Flow|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
681508|NCT00320801|P1|Participant Flow|Run-in Period|(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
681509|NCT00320801|O4|Outcome|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
681510|NCT00320801|O3|Outcome|Run-in Period|The run-in period was designed to determine tolerability of BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
681511|NCT00320801|O2|Outcome|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
681512|NCT00320801|O1|Outcome|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
681513|NCT00320801|E4|Reported Event|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
681514|NCT00320801|E3|Reported Event|Open-label Run-in Period|The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase.
681515|NCT00320801|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
681516|NCT00320801|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
681517|NCT00320788|B6|Baseline|Total|Total of all reporting groups
681518|NCT00320788|B5|Baseline|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
681519|NCT00320788|B4|Baseline|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
681520|NCT00320788|B3|Baseline|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
681521|NCT00320788|B2|Baseline|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
681522|NCT00320788|B1|Baseline|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
681523|NCT00320788|P5|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12|Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
681524|NCT00320788|P4|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
681525|NCT00320788|P3|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
681526|NCT00320788|P2|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
681527|NCT00320788|P1|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
681528|NCT00320788|O6|Outcome|Total|
681529|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
681530|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
681531|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
681532|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
681537|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
681538|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
681539|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
681540|NCT00320788|O6|Outcome|Total|
681541|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
681542|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
681543|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
681544|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
681545|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
681546|NCT00320788|O6|Outcome|Total|
681547|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
681548|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
681549|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
681550|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
681551|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
681552|NCT00320788|O6|Outcome|Total|
681553|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
681554|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
681555|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
681556|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5mg of aflibercept injection at 12 week intervals through Week 12.
681557|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5mg of aflibercept injection at 4 week intervals through Week 12.
681558|NCT00320788|O6|Outcome|Total|
681559|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
681560|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
681561|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
681562|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
681563|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
681564|NCT00320788|E5|Reported Event|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
681565|NCT00320788|E4|Reported Event|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
681566|NCT00320788|E3|Reported Event|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
681567|NCT00320788|E2|Reported Event|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
681568|NCT00320788|E1|Reported Event|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
681569|NCT00320749|B1|Baseline|Capecitabine, Gemcitabine and Docetaxel|Docetaxel i.v. over 30 min on days 1 and 8; Capecitabine p.o. in split doses bid on days 8-21, Gemcitabine i.v. over 75 min on days 8 and 15.
681570|NCT00320749|P3|Participant Flow|Dose Level 3|Docetaxel at 36 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
681571|NCT00320749|P2|Participant Flow|Dose Level 2|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
681572|NCT00320749|P1|Participant Flow|Dose Level 1|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
681573|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
681574|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
681575|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|"Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.~Capecitabine: Will be give on days 8-21~Docetaxel: Will be given on days 1 and 8,~Gemcitabine: A fixed dose rate will be give on days 8 and 15."
681647|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681576|NCT00320749|E1|Reported Event|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
681577|NCT00320710|B4|Baseline|Total|Total of all reporting groups
681578|NCT00320710|B3|Baseline|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
681579|NCT00320710|B2|Baseline|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681580|NCT00320710|B1|Baseline|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681581|NCT00320710|P3|Participant Flow|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
681582|NCT00320710|P2|Participant Flow|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681583|NCT00320710|P1|Participant Flow|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681584|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681585|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681586|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681587|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681588|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681589|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681590|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681591|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681592|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681593|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681594|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681595|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681596|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681597|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681598|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681599|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681600|NCT00320710|E3|Reported Event|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
681601|NCT00320710|E2|Reported Event|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
681602|NCT00320710|E1|Reported Event|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
681603|NCT00320671|B3|Baseline|Total|Total of all reporting groups
681604|NCT00320671|B2|Baseline|Participants Will Take Risperidone|"Participants will take risperidone~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end."
681605|NCT00320671|B1|Baseline|Participants Will Take Aripiprazole|"Participants will take aripiprazole~Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end."
681606|NCT00320671|P2|Participant Flow|Participants Will Take Risperidone Arm 2|-96 participants were randomized to to Arm 2
681607|NCT00320671|P1|Participant Flow|Participants Will Take Aripiprazole Arm 1|-102 were allocated to Arm 1.
681671|NCT00320528|B1|Baseline|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681608|NCT00320671|O2|Outcome|Percentage of Participants That Reposonded to Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
681609|NCT00320671|O1|Outcome|Percentage of Participants That Reposonded to Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
681610|NCT00320671|E2|Reported Event|Participants Will Take Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
681611|NCT00320671|E1|Reported Event|Participants Will Take Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
681612|NCT00320606|B1|Baseline|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
681613|NCT00320606|P1|Participant Flow|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
681614|NCT00320606|O1|Outcome|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
681615|NCT00320606|E1|Reported Event|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
681616|NCT00320593|B3|Baseline|Total|Total of all reporting groups
681617|NCT00320593|B2|Baseline|Single Vision Lenses (SVLs)|Standard single vision lenses
681618|NCT00320593|B1|Baseline|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681619|NCT00320593|P2|Participant Flow|Single Vision Lenses (SVLs)|Standard single vision lenses
681620|NCT00320593|P1|Participant Flow|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681621|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681622|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681623|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681624|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681625|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681626|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681627|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681628|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681629|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681630|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681631|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681632|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681633|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681634|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681635|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681636|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681637|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
681638|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681639|NCT00320593|E2|Reported Event|Single Vision Lenses (SVLs)|Standard single vision lenses
681640|NCT00320593|E1|Reported Event|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
681641|NCT00320541|B3|Baseline|Total|Total of all reporting groups
681642|NCT00320541|B2|Baseline|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681643|NCT00320541|B1|Baseline|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681644|NCT00320541|P2|Participant Flow|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681645|NCT00320541|P1|Participant Flow|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681646|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681872|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
681648|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681649|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681650|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681651|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681652|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681653|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681654|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681655|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681656|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681657|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681658|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681659|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681660|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681661|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681662|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681663|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681664|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681665|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681666|NCT00320541|E2|Reported Event|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681667|NCT00320541|E1|Reported Event|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
681668|NCT00320528|B4|Baseline|Total|Total of all reporting groups
681669|NCT00320528|B3|Baseline|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681670|NCT00320528|B2|Baseline|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681672|NCT00320528|P3|Participant Flow|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681673|NCT00320528|P2|Participant Flow|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681674|NCT00320528|P1|Participant Flow|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681675|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681676|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681677|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681678|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681679|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681680|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681681|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681682|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681683|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681684|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681685|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681686|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681687|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681688|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681689|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681690|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681691|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681692|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681693|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681694|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681695|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681696|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681697|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681698|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681699|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681700|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681701|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681702|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681703|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681704|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681705|NCT00320528|E3|Reported Event|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681706|NCT00320528|E2|Reported Event|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681707|NCT00320528|E1|Reported Event|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
681708|NCT00320515|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
681709|NCT00320515|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
681710|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
681711|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
681712|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
681713|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
681714|NCT00320515|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
681715|NCT00320489|B3|Baseline|Total|Total of all reporting groups
681716|NCT00320489|B2|Baseline|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681717|NCT00320489|B1|Baseline|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681718|NCT00320489|P2|Participant Flow|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681719|NCT00320489|P1|Participant Flow|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681720|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681721|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
682059|NCT00320190|E1|Reported Event|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
681722|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681723|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681724|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681725|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681726|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681727|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681728|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681729|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681730|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681731|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681732|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681733|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681734|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681735|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681736|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681737|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681738|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681739|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681740|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681741|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681742|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681743|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681744|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681745|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681746|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681747|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681748|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681749|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681750|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681751|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681752|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681753|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681754|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681755|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681756|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681757|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681758|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681759|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681760|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681761|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681762|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681763|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681764|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681765|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681766|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681767|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681768|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681769|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681770|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681771|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681772|NCT00320489|E2|Reported Event|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
681773|NCT00320489|E1|Reported Event|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
681774|NCT00320424|B1|Baseline|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681775|NCT00320424|P1|Participant Flow|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 milligrams (mg) by subcutaneous (s.c.) injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681776|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681777|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681778|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681873|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
681779|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681780|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681781|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681782|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681783|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681784|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681785|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681786|NCT00320424|O1|Outcome|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681787|NCT00320424|E1|Reported Event|Fondaparinux Sodium 2.5 mg s.c.|Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681788|NCT00320411|B1|Baseline|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681789|NCT00320411|P1|Participant Flow|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681790|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681791|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681792|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681793|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681794|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681795|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681796|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681797|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681798|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681799|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681800|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681801|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681802|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681803|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681804|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681805|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681806|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681807|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681808|NCT00320411|E1|Reported Event|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
681809|NCT00320398|B3|Baseline|Total|Total of all reporting groups
681810|NCT00320398|B2|Baseline|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681874|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
681875|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
681811|NCT00320398|B1|Baseline|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681812|NCT00320398|P2|Participant Flow|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681813|NCT00320398|P1|Participant Flow|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 milligram (mg) administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681814|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681815|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681816|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681817|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681818|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681819|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681820|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681821|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681822|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681823|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681824|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681876|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
681877|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
681825|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681826|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681827|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681828|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681829|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681830|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681831|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681832|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681833|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681834|NCT00320398|O2|Outcome|Fondaparinux 2.5 mg|Eligible participants in this arm received fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681835|NCT00320398|O1|Outcome|Fondaparinux 1.5 mg|Eligible participants in this arm received fondaparinux at 1.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681836|NCT00320398|E2|Reported Event|Fondaparinux 2.5 mg|Eligible participants in this arm received Fondaparinux at 2.5 mg, administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681837|NCT00320398|E1|Reported Event|Fondaparinux 1.5 mg|Eligible participants in this arm received Fondaparinux at 1.5 milligram (mg) administered as a subcutaneous injection once daily for 10 to 14 days (between Day 2 and Day 11– 15), (where Day 1 was the day of surgery). The first injection of the study drug was given 24 + or – 2 hours after the surgical closure. From Day 3 onwards the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2).
681838|NCT00320385|B3|Baseline|Total|Total of all reporting groups
681839|NCT00320385|B2|Baseline|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681840|NCT00320385|B1|Baseline|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681841|NCT00320385|P2|Participant Flow|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681842|NCT00320385|P1|Participant Flow|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681843|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681844|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681845|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681846|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681847|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681848|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681849|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681850|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681851|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681852|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681853|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681854|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681855|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681856|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681857|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681858|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681859|NCT00320385|E2|Reported Event|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
681860|NCT00320385|E1|Reported Event|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
681861|NCT00320372|B4|Baseline|Total|Total of all reporting groups
681862|NCT00320372|B3|Baseline|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy. Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
681863|NCT00320372|B2|Baseline|VNS Therapy D-21 Rollover|Subjects that entered the TRD Registry, having previously participated in the D-21 study and still being treated with VNS Therapy treatment were included within the VNS Therapy group. Based on the duration from initial implant to enrollment date, the D-21 rollover patients entered at the appropriate D-23 follow-up interval (i.e., patient enrolls at 24 months post implant for their first D-23 follow up visit. This 24 month visit corresponds to the 24 month follow up in the TRD Registry). Starting with the first TRD Registry visit, the D-21 long-term patients were to follow the same data collection schedule as other Original VNS and TAU Registry patients.
681864|NCT00320372|B1|Baseline|VNS Therapy D-23 Original|Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm.
681865|NCT00320372|P2|Participant Flow|Treatment as Usual (TAU)|Disposition of study patients from baseline to the end of the study. The TAU arm were subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
681866|NCT00320372|P1|Participant Flow|VNS Therapy|Disposition of study patients from baseline to the end of the study. The VNS Therapy arm, was comprised of D-23 Original patients (Patients that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm) and D-21 Rollover patients (Patients that entered the TRD Registry, having previously participated in the D-21 study-NCT00305565 and still being treated with VNS Therapy).
681867|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
681868|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
681869|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
681870|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Change from Baseline Score
681871|NCT00320372|O1|Outcome|VNS Therapy|Change from Baseline Score
681879|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
681880|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
681881|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
681882|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
681883|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Remitters (Percentage of Subjects in Remission)
681884|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Remitters (Percentage of Subjects in Remission)
681885|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Time until recurrence based on the MADRS
681886|NCT00320372|O1|Outcome|VNS Therapy|Time until recurrence based on the MADRS
681887|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Responders (Percentage of Responders)
681888|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Responders (Percentage of Responders)
681889|NCT00320372|E1|Reported Event|Safety Events|N/A (not collected)
681890|NCT00320281|B3|Baseline|Total|Total of all reporting groups
681891|NCT00320281|B2|Baseline|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
681892|NCT00320281|B1|Baseline|Group 1-Botox A Group|This group received the active drug, botox a injections.
681893|NCT00320281|P2|Participant Flow|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
681894|NCT00320281|P1|Participant Flow|Group 1-Botox A Group|This group received the active drug, botox a injections.
681895|NCT00320281|O2|Outcome|Group 2-saline Group|Those randomized to this treatment group received injections based on treatment plan devised by study PI and study physical therapist. 25 cc of saline were used for these injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
681896|NCT00320281|O1|Outcome|Group 1-Botox A Group|Those randomized to this treatment group received injections based on treatment plan designed by PI and study physical therapist. Botulism toxin A was diluted in 25 cc of saline for the injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
681897|NCT00320281|E2|Reported Event|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
681898|NCT00320281|E1|Reported Event|Group 1-Botox A Group|This group received the active drug, botox a injections.
681899|NCT00320255|B7|Baseline|Total|Total of all reporting groups
681900|NCT00320255|B6|Baseline|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681901|NCT00320255|B5|Baseline|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681902|NCT00320255|B4|Baseline|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681903|NCT00320255|B3|Baseline|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681904|NCT00320255|B2|Baseline|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681905|NCT00320255|B1|Baseline|Cohort 1: Placebo|Participants received placebo tablets once daily
681906|NCT00320255|P6|Participant Flow|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681907|NCT00320255|P5|Participant Flow|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681908|NCT00320255|P4|Participant Flow|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681909|NCT00320255|P3|Participant Flow|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681910|NCT00320255|P2|Participant Flow|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681911|NCT00320255|P1|Participant Flow|Cohort 1: Placebo|Participants received placebo tablets once daily
681912|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681913|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681914|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681915|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681916|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681917|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681918|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
682060|NCT00320112|B3|Baseline|Total|Total of all reporting groups
681919|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681920|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681921|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681922|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681923|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681924|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681925|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681926|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681927|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681928|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681929|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681930|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681931|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681932|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681933|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681934|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681935|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681936|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681937|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681938|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681939|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681940|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681941|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681942|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681943|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681944|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681945|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681946|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681947|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681948|NCT00320255|O6|Outcome|Cohort 2: Apixiban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681949|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681950|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681951|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681952|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681953|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681954|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
682092|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
681955|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681956|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681957|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681958|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681959|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681960|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681961|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681962|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681963|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681964|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681965|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681966|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681967|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681968|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681969|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681970|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681971|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681972|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681973|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681974|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681975|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681976|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681977|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681978|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681979|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681980|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681981|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681982|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681983|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
681984|NCT00320255|E6|Reported Event|Cohort : Apixaban, 5 mg|:Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
681985|NCT00320255|E5|Reported Event|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
681986|NCT00320255|E4|Reported Event|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
681987|NCT00320255|E3|Reported Event|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
681988|NCT00320255|E2|Reported Event|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
681989|NCT00320255|E1|Reported Event|Cohort 1: Placebo|Participants received placebo tablets once daily
681990|NCT00320242|B1|Baseline|All Study Participants Who Completed Protocol|This analysis includes all study participants who completed the protocol (n = 26)
682018|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
681991|NCT00320242|P2|Participant Flow|2 Month Baseline Before Visual Cue|2 month baseline using the laserlight visual cue, followed by 1 additional month using the laserlight visual cue. This group served as an active comparator control for comparison with Group 1during the 2nd month, when group 1 did use the visual cue but group 2 continued without the visual cue.
681992|NCT00320242|P1|Participant Flow|1 mo Baseline Before Visual Cue|1 mo baseline using the cane/walker without the laserlight visual cue, followed by additional time using the visual cue
681993|NCT00320242|O1|Outcome|1 or 2 Month Baseline Before Use of Laserlight Visual Cue|subjects had a 1 month baseline before use of laserlight visual cue
681994|NCT00320242|O1|Outcome|All Study Participants Who Completed Protocol|All 26 Study Participants who completed protocol. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue.
681995|NCT00320242|O1|Outcome|All Study Participants Who Completed Protocol|All 26 subjects who entered the study and completed the study protocol.
681996|NCT00320242|O1|Outcome|1 Month Baseline Before Use of Laserlight Visual Cue|subjects had a 1 month baseline before use of laserlight visual cue
681997|NCT00320242|E1|Reported Event|All Study Participants|
681998|NCT00320216|B6|Baseline|Total|Total of all reporting groups
681999|NCT00320216|B5|Baseline|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682000|NCT00320216|B4|Baseline|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682001|NCT00320216|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682002|NCT00320216|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682003|NCT00320216|B1|Baseline|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
682004|NCT00320216|P5|Participant Flow|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
682005|NCT00320216|P4|Participant Flow|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
682006|NCT00320216|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
682007|NCT00320216|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
682008|NCT00320216|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
682009|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682010|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682011|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682012|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682013|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
682014|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682015|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682016|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682017|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682056|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682057|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682019|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682020|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682021|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682022|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682023|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
682024|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682025|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682026|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682027|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
682028|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
682029|NCT00320216|E10|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
682030|NCT00320216|E9|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
682031|NCT00320216|E8|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
682032|NCT00320216|E7|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
682033|NCT00320216|E6|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -> receiving ustekinumab 90 mg at Week 20.
682034|NCT00320216|E5|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
682035|NCT00320216|E4|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
682036|NCT00320216|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
682037|NCT00320216|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
682038|NCT00320216|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
682039|NCT00320190|B3|Baseline|Total|Total of all reporting groups
682040|NCT00320190|B2|Baseline|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682041|NCT00320190|B1|Baseline|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682042|NCT00320190|P2|Participant Flow|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682043|NCT00320190|P1|Participant Flow|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682044|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682045|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682046|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682047|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682048|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682049|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682050|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682051|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682052|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682053|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682054|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
682055|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
682061|NCT00320112|B2|Baseline|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
682062|NCT00320112|B1|Baseline|Receiprocal Peer Support|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
682063|NCT00320112|P2|Participant Flow|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts. particpants were also provided information about nurse case managements services and encouraged to use the service regularly.
682064|NCT00320112|P1|Participant Flow|Reciprocal Diabetes Peer Support Program (RPS)|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
682065|NCT00320112|O2|Outcome|Nurse Case Management Grouop|patients were provided an educational session and discussed nurse case management services. participants were encouraged to meet wit their case manager regularly.
682066|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|patients were age-matched and assigned to a peer. they were asked to make weekly calls using a telephone support system to check in and discuss their diabetes
682067|NCT00320112|O2|Outcome|Nurse Case Management Group|participants in the nurse case management group receive initial educational session on diabetes and information bout case management services. they are encouraged to contact their nurse case manager regularly.
682068|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|participants are age-matched with a peer and asked to talk with each other weekly using a telephone support sytem
682069|NCT00320112|O2|Outcome|Change in Systsolic at 6 Months for Nurse Mgt Group|change in systolic blood pressure from baseline to six months in the nurse case management group
682070|NCT00320112|O1|Outcome|Change in Systolic BP at 6 Months for Peer Support Group|change in systolic blood pressure from baseline to six months among participants in the peer support group
682071|NCT00320112|O2|Outcome|Nurse Case Management Group|Nurse Case Management group was offered an educational session with nurse case managers on diabetes and informed of case management services. they were encouraged to utilize this service regularly.
682072|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
682073|NCT00320112|E2|Reported Event|Nurse Case Management Intervention|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
682074|NCT00320112|E1|Reported Event|Reciprocal Peer Support Intervention|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
682075|NCT00319982|B3|Baseline|Total|Total of all reporting groups
682076|NCT00319982|B2|Baseline|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682077|NCT00319982|B1|Baseline|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682078|NCT00319982|P2|Participant Flow|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682079|NCT00319982|P1|Participant Flow|I- Diltiazem (Active Arm)|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682080|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682081|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682082|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682083|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682084|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682085|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682086|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682087|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682088|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682089|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682090|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682091|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682093|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682094|NCT00319982|E2|Reported Event|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
682095|NCT00319982|E1|Reported Event|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
682096|NCT00319839|B1|Baseline|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
682097|NCT00319839|P1|Participant Flow|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
682098|NCT00319839|O1|Outcome|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
682099|NCT00319839|O1|Outcome|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
682100|NCT00319839|O1|Outcome|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
682101|NCT00319839|E1|Reported Event|Abraxane Plus Cetuximab|Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
682102|NCT00319748|B1|Baseline|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
682103|NCT00319748|P1|Participant Flow|Patients Treated With 852A|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
682104|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of TNF-a in patients treated with 852A.
682105|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of sCD40L in patients treated with 852A.
682106|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of MIP-1b in patients treated with 852A.
682107|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for Macrophage Inflammatory Protein-1 Alpha (cytokine) level in patients treated with 852A.
682108|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IP-10 in patients treated with 852A.
682109|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IL1ra in patients treated with 852A.
682110|NCT00319748|O1|Outcome|Patients With Ovarian Cancer|Participants with ovarian cancer who received all 24 doses of 852A.
682111|NCT00319748|E1|Reported Event|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
682112|NCT00319735|B1|Baseline|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682113|NCT00319735|P1|Participant Flow|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682114|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682163|NCT00319592|P2|Participant Flow|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682164|NCT00319592|P1|Participant Flow|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682115|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682116|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682117|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682118|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682119|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682120|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682121|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682122|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682165|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682166|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682167|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682168|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682169|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682123|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682124|NCT00319735|E1|Reported Event|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
682125|NCT00319696|B1|Baseline|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682126|NCT00319696|P1|Participant Flow|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682127|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682128|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682129|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682130|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682131|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682132|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682133|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682134|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682135|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682136|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682137|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682138|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682139|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682140|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682141|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682142|NCT00319696|O6|Outcome|At Least 5 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
682143|NCT00319696|O5|Outcome|At Least 4 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
682144|NCT00319696|O4|Outcome|At Least 3 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
682145|NCT00319696|O3|Outcome|At Least 2 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
682146|NCT00319696|O2|Outcome|At Least 1 New Ulcer|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
682147|NCT00319696|O1|Outcome|0 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
682148|NCT00319696|E1|Reported Event|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
682149|NCT00319644|B3|Baseline|Total|Total of all reporting groups
682150|NCT00319644|B2|Baseline|Tracheal Aspirates|No intervention. Standard of care in ICU.
682151|NCT00319644|B1|Baseline|Minibal Arm|Using Mini bronchoalveolar lavage
682152|NCT00319644|P2|Participant Flow|Minibal Arm|Using Mini bronchoalveolar lavage
682153|NCT00319644|P1|Participant Flow|Tracheal Aspirates|No intervention. Standard of care in ICU.
682154|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
682155|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
682156|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
682157|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
682158|NCT00319644|E2|Reported Event|Tracheal Aspirates|No intervention. Standard of care in ICU.
682159|NCT00319644|E1|Reported Event|Minibal Arm|Using Mini bronchoalveolar lavage
682160|NCT00319592|B3|Baseline|Total|Total of all reporting groups
682161|NCT00319592|B2|Baseline|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682162|NCT00319592|B1|Baseline|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682170|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682171|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682172|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682173|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682174|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682175|NCT00319592|E2|Reported Event|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
682176|NCT00319592|E1|Reported Event|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
682177|NCT00319553|B3|Baseline|Total|Total of all reporting groups
682178|NCT00319553|B2|Baseline|Boostrix® Vaccine Group|
682179|NCT00319553|B1|Baseline|Adacel® Vaccine Group|
682180|NCT00319553|P2|Participant Flow|Boostrix® Vaccine Group|
682181|NCT00319553|P1|Participant Flow|Adacel® Vaccine Group|
682182|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
682183|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
682184|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
682185|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
682186|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
682187|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
682188|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
682189|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
682190|NCT00319553|E2|Reported Event|Boostrix® Vaccine Group|
682191|NCT00319553|E1|Reported Event|Adacel® Vaccine Group|
682192|NCT00319501|B3|Baseline|Total|Total of all reporting groups
682193|NCT00319501|B2|Baseline|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682194|NCT00319501|B1|Baseline|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
682195|NCT00319501|P2|Participant Flow|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682196|NCT00319501|P1|Participant Flow|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
682197|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
682198|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
682199|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
682200|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
682201|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
682202|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682203|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682231|NCT00319449|E1|Reported Event|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682232|NCT00319436|B3|Baseline|Total|Total of all reporting groups
682204|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682205|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682206|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682207|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682208|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682209|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682210|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682211|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682212|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682213|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682214|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
682215|NCT00319501|E4|Reported Event|Placebo (Double-blind Period)|Participants received a single dose of diazepam-matching solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682216|NCT00319501|E3|Reported Event|Diazepam (Open-label Extension)|Participants continued to receive diazepam in an age- and weight-appropriate dose of administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed at the onset of an ARS episode. Participants were to continue until drug became marketed.
682217|NCT00319501|E2|Reported Event|Diazepam (Open-label Period)|Participants received an age- and weight-appropriate dose of placebo solution administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed.
682218|NCT00319501|E1|Reported Event|Diazepam (Double-blind Period)|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
682219|NCT00319449|B3|Baseline|Total|Total of all reporting groups
682220|NCT00319449|B2|Baseline|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682221|NCT00319449|B1|Baseline|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682222|NCT00319449|P2|Participant Flow|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682223|NCT00319449|P1|Participant Flow|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682224|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682225|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682226|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682227|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682228|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682229|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682230|NCT00319449|E2|Reported Event|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
682233|NCT00319436|B2|Baseline|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682234|NCT00319436|B1|Baseline|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
682235|NCT00319436|P2|Participant Flow|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682236|NCT00319436|P1|Participant Flow|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682237|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682238|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682239|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682260|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682261|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682262|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682240|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682241|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682242|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682243|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682244|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682245|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682246|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682263|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682264|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682265|NCT00319254|E1|Reported Event|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682247|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682248|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682249|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682250|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
682251|NCT00319436|E2|Reported Event|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
682252|NCT00319436|E1|Reported Event|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
682253|NCT00319254|B1|Baseline|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682254|NCT00319254|P1|Participant Flow|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682255|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682256|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682257|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682258|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682259|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
682266|NCT00319111|B1|Baseline|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682267|NCT00319111|P1|Participant Flow|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682268|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682269|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682270|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682271|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682272|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682273|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682274|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682275|NCT00319111|E1|Reported Event|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
682276|NCT00319098|B5|Baseline|Total|Total of all reporting groups
682277|NCT00319098|B4|Baseline|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682278|NCT00319098|B3|Baseline|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682279|NCT00319098|B2|Baseline|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682280|NCT00319098|B1|Baseline|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682281|NCT00319098|P2|Participant Flow|Fluarix+Placebo Group|Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.
682282|NCT00319098|P1|Participant Flow|GSK1562902A Group|Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.
682283|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682284|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682285|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682286|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682287|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682288|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682289|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682290|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682291|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682292|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682293|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682294|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682295|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682296|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682297|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682298|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682299|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682300|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682301|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682302|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682303|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682304|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682305|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682306|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682307|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682308|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682309|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682310|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682311|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682312|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682313|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682314|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682315|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682316|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682317|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682318|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682319|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682320|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682321|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682322|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682323|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682324|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682325|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682326|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682327|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682328|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682329|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682330|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682331|NCT00319098|O4|Outcome|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682332|NCT00319098|O3|Outcome|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682333|NCT00319098|O2|Outcome|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682334|NCT00319098|O1|Outcome|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682335|NCT00319098|E4|Reported Event|Fluarix+Placebo >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682336|NCT00319098|E3|Reported Event|Fluarix+Placebo 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm.
682337|NCT00319098|E2|Reported Event|GSK1562902A >60 YOA Group|Male and female subjects over (>) 60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682338|NCT00319098|E1|Reported Event|GSK1562902A 18-60 YOA Group|Male and female subjects 18-60 years of age (YOA) received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm.
682339|NCT00319046|B1|Baseline|Miglustat|miglustat oral capsules 100mg three times a day
682340|NCT00319046|P1|Participant Flow|Miglustat|miglustat oral capsules 100mg three times a day
682341|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
682342|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
682343|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
682344|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
682345|NCT00319046|E1|Reported Event|Miglustat|miglustat oral capsules 100mg three times a day
682346|NCT00319020|B3|Baseline|Total|Total of all reporting groups
682347|NCT00319020|B2|Baseline|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682348|NCT00319020|B1|Baseline|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682349|NCT00319020|P2|Participant Flow|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682350|NCT00319020|P1|Participant Flow|Patients With Previous Bosentan|"This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiatied at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682351|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682352|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682353|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682354|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682355|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682356|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682357|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682358|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682359|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682360|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682361|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682362|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682363|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682364|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682365|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682366|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682367|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682368|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682369|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682370|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682669|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682371|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682372|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
682373|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
682374|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
682375|NCT00319020|E3|Reported Event|Single Arm Bosentan_Total|All patients included in Future 1 / FUTURE 2 whether they received bosentan or not bosentan before enrollment in FUTURE 1
682376|NCT00319020|E2|Reported Event|Bosentan_naive Patients|Patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
682377|NCT00319020|E1|Reported Event|Patients With Previous Bosentan|Patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
682378|NCT00318929|B1|Baseline|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
682379|NCT00318929|P1|Participant Flow|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
682380|NCT00318929|O1|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
682381|NCT00318929|O1|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
682382|NCT00318929|O1|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
682383|NCT00318929|O1|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
682384|NCT00318929|E1|Reported Event|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
682385|NCT00318812|B3|Baseline|Total|Total of all reporting groups
682386|NCT00318812|B2|Baseline|Iron Sucrose|Iron Sucrose q month IV x 6 months
682387|NCT00318812|B1|Baseline|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
682388|NCT00318812|P2|Participant Flow|Iron Sucrose|Iron Sucrose q month IV x 6 months
682389|NCT00318812|P1|Participant Flow|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
682390|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
682391|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
682392|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
682393|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
682394|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
682395|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
682396|NCT00318812|E2|Reported Event|Iron Sucrose|Iron Sucrose q month IV x 6 months
682397|NCT00318812|E1|Reported Event|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
682398|NCT00318708|B3|Baseline|Total|Total of all reporting groups
682399|NCT00318708|B2|Baseline|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
682400|NCT00318708|B1|Baseline|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
682401|NCT00318708|P2|Participant Flow|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682402|NCT00318708|P1|Participant Flow|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682403|NCT00318708|O2|Outcome|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
682404|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
682405|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682406|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682407|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682408|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682409|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682410|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682411|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682412|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682413|NCT00318708|O2|Outcome|Placebo + Fluticasone|"placebo clarithromycin twice daily + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)~fluticasone propionate: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)~placebo clarithromycin: placebo clarithromycin twice daily"
682414|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|"clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)~clarithromycin: clarithromycin 500 mg twice daily (Biaxin)~fluticasone propionate: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)"
682415|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682416|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
682417|NCT00318708|E2|Reported Event|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
682418|NCT00318708|E1|Reported Event|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
682419|NCT00318656|B3|Baseline|Total|Total of all reporting groups
682420|NCT00318656|B2|Baseline|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682421|NCT00318656|B1|Baseline|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682422|NCT00318656|P2|Participant Flow|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682423|NCT00318656|P1|Participant Flow|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682424|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682425|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682426|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682427|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682428|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682429|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682443|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682430|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682431|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682432|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682433|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682434|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682435|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682436|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682437|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682438|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682439|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682440|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682441|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682442|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682444|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682445|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682446|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682447|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682448|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682449|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682450|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682451|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682452|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682453|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682454|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682455|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682456|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
682457|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
682458|NCT00318591|B3|Baseline|Total|Total of all reporting groups
682459|NCT00318591|B2|Baseline|Conveen Uncoated|Uncoated intermittent catheter
682460|NCT00318591|B1|Baseline|SpeediCath|Hydrophilic coated intermittent catheter
682461|NCT00318591|P2|Participant Flow|Conveen Uncoated|Uncoated intermittent catheter
682462|NCT00318591|P1|Participant Flow|SpeediCath|Hydrophilic coated intermittent catheter
682463|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
682464|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
682465|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
682466|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
682467|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
682468|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
682469|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
682470|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
682471|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
682472|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
682473|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
682474|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
682475|NCT00318591|O2|Outcome|Conveen Uncoated|uncoated intermittent catheter
682476|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
682477|NCT00318591|E2|Reported Event|Conveen Uncoated|Uncoated intermittent catheter
682478|NCT00318591|E1|Reported Event|SpeediCath|Hydrophilic coated intermittent catheter
682479|NCT00318565|B1|Baseline|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
682480|NCT00318565|P1|Participant Flow|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
682481|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
682482|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
682483|NCT00318565|E1|Reported Event|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
682484|NCT00318474|B3|Baseline|Total|Total of all reporting groups
682485|NCT00318474|B2|Baseline|Placebo|Subjects receive ACEi and FOS and placebo.
682486|NCT00318474|B1|Baseline|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
682487|NCT00318474|P2|Participant Flow|Placebo|Subjects receive ACEi and FOS and placebo.
682488|NCT00318474|P1|Participant Flow|Mycophenolate Mofetil (MMF)|"Subjects receive angiotensin-converting enzyme inhibitors (ACEi), fish oil supplements (FOS), and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
682489|NCT00318474|O2|Outcome|Placebo|Subjects receive ACEi and FOS and placebo.
682490|NCT00318474|O1|Outcome|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
682491|NCT00318474|E2|Reported Event|Placebo|Subjects receive ACEi and FOS and placebo.
682492|NCT00318474|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
682493|NCT00318461|B6|Baseline|Total|Total of all reporting groups
682494|NCT00318461|B5|Baseline|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682495|NCT00318461|B4|Baseline|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682496|NCT00318461|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682497|NCT00318461|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682498|NCT00318461|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682499|NCT00318461|P5|Participant Flow|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682500|NCT00318461|P4|Participant Flow|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682501|NCT00318461|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682502|NCT00318461|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682503|NCT00318461|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682504|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682505|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682506|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682507|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682508|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682509|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682510|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682511|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682512|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682513|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682514|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682515|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682516|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682517|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682518|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682519|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682520|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682521|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682522|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682523|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682524|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682525|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682526|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682527|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682528|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682529|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682530|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682531|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682532|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682533|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682534|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682535|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682536|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682537|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682538|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682539|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682540|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682541|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682542|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682543|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682544|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682545|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682546|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682547|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682548|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682549|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682550|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682551|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682552|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682553|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682554|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682555|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682556|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682667|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682557|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682558|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682559|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682560|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682561|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682562|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682563|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682564|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682565|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682566|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682567|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682568|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682569|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682570|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682571|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682572|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682573|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682574|NCT00318461|E5|Reported Event|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682575|NCT00318461|E4|Reported Event|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682576|NCT00318461|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682577|NCT00318461|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682578|NCT00318461|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
682579|NCT00318409|B3|Baseline|Total|Total of all reporting groups
682580|NCT00318409|B2|Baseline|Placebo|Placebo 300mg daily
682581|NCT00318409|B1|Baseline|Bupropion|Bupropion XL 300mg daily
682582|NCT00318409|P2|Participant Flow|Placebo|Placebo 300mg daily
682583|NCT00318409|P1|Participant Flow|Bupropion|Bupropion XL 300mg daily
682584|NCT00318409|O2|Outcome|Placebo|
682585|NCT00318409|O1|Outcome|Bupropion|
682586|NCT00318409|O2|Outcome|Placebo|
682587|NCT00318409|O1|Outcome|Bupropion|
682588|NCT00318409|O2|Outcome|Placebo|
682589|NCT00318409|O1|Outcome|Bupropion|
682590|NCT00318409|O2|Outcome|Placebo|
682591|NCT00318409|O1|Outcome|Bupropion|
682592|NCT00318409|O2|Outcome|Placebo|
682593|NCT00318409|O1|Outcome|Bupropion|
682594|NCT00318409|O2|Outcome|Placebo|
682595|NCT00318409|O1|Outcome|Bupropion|
682596|NCT00318409|O2|Outcome|Placebo|
682597|NCT00318409|O1|Outcome|Bupropion|
682598|NCT00318409|O1|Outcome|Persons Screened|
682599|NCT00318409|E2|Reported Event|Placebo|
682600|NCT00318409|E1|Reported Event|Bupropion|
682668|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682601|NCT00318370|B1|Baseline|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
682602|NCT00318370|P3|Participant Flow|Maintenance Far Only|Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
682603|NCT00318370|P2|Participant Flow|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
682604|NCT00318370|P1|Participant Flow|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
682605|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.~Maintenace Far Only: farletuzumab, 100 mg/m2"
682606|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.~Maintenace Far Only: farletuzumab, 100 mg/m2"
682607|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
682608|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
682609|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
682610|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
682611|NCT00318370|O1|Outcome|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
682612|NCT00318370|E1|Reported Event|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
682613|NCT00318292|B3|Baseline|Total|Total of all reporting groups
682614|NCT00318292|B2|Baseline|Placebo|Placebo for preemptive local analgesia.
682615|NCT00318292|B1|Baseline|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
682616|NCT00318292|P2|Participant Flow|Placebo|Placebo for preemptive local analgesia.
682617|NCT00318292|P1|Participant Flow|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
682618|NCT00318292|O2|Outcome|Placebo|Placebo for preemptive local analgesia.
682619|NCT00318292|O1|Outcome|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
682620|NCT00318292|E2|Reported Event|Placebo|Placebo for preemptive local analgesia.
682621|NCT00318292|E1|Reported Event|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
682622|NCT00318136|B1|Baseline|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
682623|NCT00318136|P1|Participant Flow|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
682624|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
682625|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
682626|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
682627|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
682628|NCT00318136|E1|Reported Event|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
682629|NCT00317941|B3|Baseline|Total|Total of all reporting groups
682630|NCT00317941|B2|Baseline|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682631|NCT00317941|B1|Baseline|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682632|NCT00317941|P3|Participant Flow|Group C: IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682633|NCT00317941|P2|Participant Flow|Group B: IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
682634|NCT00317941|P1|Participant Flow|Group A: IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
682635|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682636|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682637|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682638|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682639|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682640|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
682641|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682642|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
682643|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682644|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
682645|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682646|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
682647|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682648|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682649|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682650|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682651|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682652|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682653|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682654|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682655|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682656|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682657|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682658|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682659|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682660|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682661|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682662|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682663|NCT00317941|O3|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682664|NCT00317941|O2|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
682665|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
682666|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682670|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
682671|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
682672|NCT00317941|E2|Reported Event|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow.
682673|NCT00317941|E1|Reported Event|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow.
682674|NCT00317720|B1|Baseline|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg given orally daily.
682675|NCT00317720|P2|Participant Flow|BIDMC/DFCI Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 5 or 10 mg by mouth daily.~Phase II: RAD001 10 mg/kg daily~ClinicalTrials.gov ID NCT00458237"
682676|NCT00317720|P1|Participant Flow|MDACC Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 (Everolimus) 10 mg orally (PO) daily.~Phase II: RAD001 10 mg/kg daily + Trastuzumab 6 mg/kg maintenance dose~ClinicalTrials.gov ID: NCT00317720"
682677|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
682678|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
682679|NCT00317720|E1|Reported Event|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
682680|NCT00317642|B3|Baseline|Total|Total of all reporting groups
682681|NCT00317642|B2|Baseline|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682682|NCT00317642|B1|Baseline|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682683|NCT00317642|P2|Participant Flow|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682684|NCT00317642|P1|Participant Flow|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682685|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682686|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682687|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682688|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682689|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682690|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682691|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682692|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682693|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682694|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682695|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682696|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682697|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682698|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682699|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682700|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682701|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682702|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682703|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682704|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682705|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682706|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682707|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682708|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682709|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682710|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682711|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682712|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682713|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682714|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682715|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682716|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682717|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682718|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682719|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682720|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682721|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682722|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682723|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682724|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682725|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682726|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682727|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682728|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682729|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682730|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682731|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682732|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682733|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682734|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682735|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682736|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682737|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682738|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682739|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682740|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682741|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682742|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682743|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682744|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682745|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682746|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682747|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682748|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682749|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682750|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682751|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682793|NCT00317239|B1|Baseline|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
682794|NCT00317239|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
682752|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682753|NCT00317642|E3|Reported Event|Overall|Combined total for the two Arms/Groups
682754|NCT00317642|E2|Reported Event|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
682755|NCT00317642|E1|Reported Event|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
682756|NCT00317473|B7|Baseline|Total|Total of all reporting groups
682757|NCT00317473|B6|Baseline|Imovax (Cohort C)|"Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days~Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days"
682758|NCT00317473|B5|Baseline|FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)|"Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682759|NCT00317473|B4|Baseline|Imovax (Cohort B)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
682760|NCT00317473|B3|Baseline|FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)|"Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682761|NCT00317473|B2|Baseline|Imovax (Cohort A)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
682762|NCT00317473|B1|Baseline|FMP1/AS02A Malaria Vaccine 10ug (Cohort A)|"Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682763|NCT00317473|P6|Participant Flow|Imovax (Cohort C)|"Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days~Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days"
682764|NCT00317473|P5|Participant Flow|FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)|"Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682765|NCT00317473|P4|Participant Flow|Imovax (Cohort B)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
682766|NCT00317473|P3|Participant Flow|FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)|"Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682767|NCT00317473|P2|Participant Flow|Imovax (Cohort A)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
682768|NCT00317473|P1|Participant Flow|FMP1/AS02A Malaria Vaccine 10ug (Cohort A)|"Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682769|NCT00317473|O6|Outcome|Imovax (Cohort C)|"Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days~Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days"
682770|NCT00317473|O5|Outcome|FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)|"Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682771|NCT00317473|O4|Outcome|Imovax (Cohort B)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
682772|NCT00317473|O3|Outcome|FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)|"Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682773|NCT00317473|O2|Outcome|Imovax (Cohort A)|Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
682774|NCT00317473|O1|Outcome|FMP1/AS02A Malaria Vaccine 10ug (Cohort A)|"Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57~FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine"
682775|NCT00317473|O3|Outcome|Overall|Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine
682776|NCT00317473|O2|Outcome|Imovax Rabies Vaccine|Subject vaccinated with Imovax Rabies Vaccine
682777|NCT00317473|O1|Outcome|FMP1/AS02A Malaria Vaccine|Subject vaccinated with FMP1/AS02A
682778|NCT00317473|O8|Outcome|Imovax Any Imm|Subjects vaccinated within all immunization cycles
682779|NCT00317473|O7|Outcome|Imovax Imm 3|Subjects 3rd vaccination with Imovax Rabies Vaccine
682780|NCT00317473|O6|Outcome|Imovax Imm 2|Subjects 2nd vaccination with Imovax Rabies Vaccine
682781|NCT00317473|O5|Outcome|Imovax Imm 1|Subjects 1st vaccination with Imovax Rabies Vaccine
682782|NCT00317473|O4|Outcome|FMP1/AS02A Any Imm|Subjects vaccinated within all immunization cycles
682783|NCT00317473|O3|Outcome|FMP1/AS02A Imm 3|Subjects 3rd vaccination with FMP1/AS02A
682784|NCT00317473|O2|Outcome|FMP1/AS02A Imm 2|Subjects 2nd vaccination with FMP1/AS02A
682785|NCT00317473|O1|Outcome|FMP1/AS02A Imm 1|Subjects 1st vaccination with FMP1/AS02A
682786|NCT00317473|O3|Outcome|Overall|Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine (cohorts A, B, and C)
682787|NCT00317473|O2|Outcome|Imovax Rabies Vaccine|Subject vaccinated with Imovax Rabies Vaccine (cohorts A, B, and C)
682788|NCT00317473|O1|Outcome|FMP1/AS02A Malaria Vaccine|Subject vaccinated with FMP1/AS02A (cohorts A, B, and C)
682789|NCT00317473|E2|Reported Event|Imovax|Subject vaccinated with Imovax Rabies Vaccine
682790|NCT00317473|E1|Reported Event|FMP1/AS02A Malaria Vaccine|Subject vaccinated with FMP1/AS02A
682791|NCT00317239|B3|Baseline|Total|Total of all reporting groups
682792|NCT00317239|B2|Baseline|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
682795|NCT00317239|P1|Participant Flow|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
682796|NCT00317239|O2|Outcome|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
682797|NCT00317239|O1|Outcome|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
682798|NCT00317239|E2|Reported Event|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
682799|NCT00317239|E1|Reported Event|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
682800|NCT00317226|B1|Baseline|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
682801|NCT00317226|P1|Participant Flow|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
682802|NCT00317226|O1|Outcome|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
682803|NCT00317226|E1|Reported Event|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
682804|NCT00317109|B3|Baseline|Total|Total of all reporting groups
682805|NCT00317109|B2|Baseline|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682806|NCT00317109|B1|Baseline|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682807|NCT00317109|P2|Participant Flow|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682808|NCT00317109|P1|Participant Flow|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682809|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682810|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682811|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682812|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682813|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682814|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682845|NCT00317044|P3|Participant Flow|Placebo|Placebo
682846|NCT00317044|P2|Participant Flow|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682815|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682816|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682817|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682818|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682819|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682820|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682821|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682822|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682823|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682824|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682825|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682826|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682827|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682847|NCT00317044|P1|Participant Flow|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682848|NCT00317044|O3|Outcome|Placebo|Placebo
682849|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
694931|NCT00282672|O2|Outcome|LGD to IMC|
682828|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682829|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682830|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682831|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682832|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682833|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682834|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682835|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682836|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682837|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682838|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682839|NCT00317109|E2|Reported Event|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682840|NCT00317109|E1|Reported Event|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
682841|NCT00317044|B4|Baseline|Total|Total of all reporting groups
682842|NCT00317044|B3|Baseline|Placebo|Placebo
682843|NCT00317044|B2|Baseline|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682844|NCT00317044|B1|Baseline|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682850|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682851|NCT00317044|O3|Outcome|Placebo|Placebo
682852|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682853|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682854|NCT00317044|O3|Outcome|Placebo|Placebo
682855|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682856|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682857|NCT00317044|O3|Outcome|Placebo|Placebo
682858|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682859|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682860|NCT00317044|O3|Outcome|Placebo|Placebo
682861|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682862|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682863|NCT00317044|O3|Outcome|Placebo|Placebo
682864|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682865|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682866|NCT00317044|O3|Outcome|Placebo|Placebo
682867|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682868|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682869|NCT00317044|O3|Outcome|Placebo|Placebo
682870|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682871|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682872|NCT00317044|O3|Outcome|Placebo|Placebo
682873|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682874|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682875|NCT00317044|O3|Outcome|Placebo|Placebo
682876|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682877|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682878|NCT00317044|O3|Outcome|Placebo|Placebo
682879|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682880|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682881|NCT00317044|O3|Outcome|Placebo|Placebo
682882|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682883|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682884|NCT00317044|O3|Outcome|Placebo|Placebo
682885|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682886|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682887|NCT00317044|E3|Reported Event|Placebo|Placebo
682888|NCT00317044|E2|Reported Event|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
682889|NCT00317044|E1|Reported Event|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
682890|NCT00316914|B3|Baseline|Total|Total of all reporting groups
682891|NCT00316914|B2|Baseline|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682892|NCT00316914|B1|Baseline|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682893|NCT00316914|P2|Participant Flow|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682894|NCT00316914|P1|Participant Flow|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682895|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682896|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682897|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682898|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682899|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682900|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682901|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682902|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682903|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682904|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682905|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682906|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682907|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682908|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682909|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682910|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682911|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682912|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682913|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682914|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682915|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682916|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682917|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682918|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682919|NCT00316914|E2|Reported Event|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682920|NCT00316914|E1|Reported Event|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
682921|NCT00316888|B3|Baseline|Total|Total of all reporting groups
682922|NCT00316888|B2|Baseline|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682923|NCT00316888|B1|Baseline|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682924|NCT00316888|P2|Participant Flow|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682925|NCT00316888|P1|Participant Flow|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682966|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682967|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682926|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682927|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682928|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682929|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682930|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682931|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682932|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682933|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682934|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682935|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682936|NCT00316888|E2|Reported Event|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682937|NCT00316888|E1|Reported Event|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
682968|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682938|NCT00316862|B1|Baseline|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
682939|NCT00316862|P1|Participant Flow|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
682940|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
682941|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
682942|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
682943|NCT00316862|E1|Reported Event|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
682944|NCT00316719|B3|Baseline|Total|Total of all reporting groups
682945|NCT00316719|B2|Baseline|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682946|NCT00316719|B1|Baseline|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682947|NCT00316719|P2|Participant Flow|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682948|NCT00316719|P1|Participant Flow|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682949|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682950|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682951|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682952|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682953|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682954|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682955|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682956|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682957|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682958|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682959|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682960|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682961|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682962|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682963|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682964|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682965|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682969|NCT00316719|E2|Reported Event|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
682970|NCT00316719|E1|Reported Event|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
682971|NCT00316706|B3|Baseline|Total|Total of all reporting groups
682972|NCT00316706|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682973|NCT00316706|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682974|NCT00316706|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682975|NCT00316706|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682976|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682977|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682978|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682979|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682980|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682981|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682982|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682983|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682984|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682985|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682986|NCT00316706|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
682987|NCT00316706|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
682988|NCT00316693|B3|Baseline|Total|Total of all reporting groups
682989|NCT00316693|B2|Baseline|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
682990|NCT00316693|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
682991|NCT00316693|P2|Participant Flow|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
682992|NCT00316693|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
682993|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
682994|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
682995|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
682996|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
682997|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
682998|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
682999|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683000|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683001|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683002|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683003|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683004|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683005|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683006|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683007|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683008|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683009|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683010|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683011|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683012|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683013|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683014|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683015|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683016|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683017|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683018|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683019|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683020|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683021|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683022|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683023|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683024|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683025|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683026|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683027|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683028|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683029|NCT00316693|E2|Reported Event|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
683030|NCT00316693|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
683031|NCT00316355|B3|Baseline|Total|Total of all reporting groups
683032|NCT00316355|B2|Baseline|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
683033|NCT00316355|B1|Baseline|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Traditional CBT: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
683034|NCT00316355|P2|Participant Flow|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
683035|NCT00316355|P1|Participant Flow|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
683036|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
683037|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
683038|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
683039|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
683094|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683888|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
683040|NCT00316355|E2|Reported Event|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
683041|NCT00316355|E1|Reported Event|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
683042|NCT00316303|B3|Baseline|Total|Total of all reporting groups
683043|NCT00316303|B2|Baseline|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
683044|NCT00316303|B1|Baseline|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683045|NCT00316303|P2|Participant Flow|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
683046|NCT00316303|P1|Participant Flow|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683047|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
683048|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683049|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
683050|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683051|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
683052|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683053|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A and hepatitis B immunizations, and any necessary treatments.
683054|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683055|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
683056|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683057|NCT00316303|E2|Reported Event|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
683058|NCT00316303|E1|Reported Event|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
683059|NCT00316277|B3|Baseline|Total|Total of all reporting groups
683060|NCT00316277|B2|Baseline|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
683061|NCT00316277|B1|Baseline|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
683062|NCT00316277|P2|Participant Flow|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
683063|NCT00316277|P1|Participant Flow|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
683064|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
683065|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
683066|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Heroin Use|
683067|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Heroin Use|
683068|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Heroin Use|
683069|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Heroin Use|
683070|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Chronic Pain|
683071|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
683072|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Chronic Pain|
683073|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
683074|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
683075|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
683076|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
683077|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
683078|NCT00316277|E2|Reported Event|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
683079|NCT00316277|E1|Reported Event|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
683080|NCT00316264|B4|Baseline|Total|Total of all reporting groups
683081|NCT00316264|B3|Baseline|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683082|NCT00316264|B2|Baseline|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683083|NCT00316264|B1|Baseline|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683084|NCT00316264|P3|Participant Flow|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683085|NCT00316264|P2|Participant Flow|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683086|NCT00316264|P1|Participant Flow|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683087|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683088|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683089|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683090|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683091|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683092|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683093|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683095|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683096|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683097|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683098|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683099|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683100|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683101|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683102|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683103|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683104|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683105|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683106|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683107|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683108|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683109|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683110|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683111|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683112|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683113|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683114|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683115|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683116|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683117|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683118|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683119|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683120|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683121|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683122|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683123|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683124|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683125|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
694932|NCT00282672|O1|Outcome|LGD to HGD|
683126|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683127|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683128|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683129|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683130|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683131|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683132|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683133|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683134|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683135|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683136|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683137|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683138|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683139|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683140|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683141|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683142|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683143|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683144|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683145|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683146|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683147|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683148|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683149|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683150|NCT00316264|E3|Reported Event|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683151|NCT00316264|E2|Reported Event|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
683152|NCT00316264|E1|Reported Event|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
683153|NCT00316225|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683154|NCT00316225|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683155|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683156|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683157|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683158|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683159|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683160|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683161|NCT00316225|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
683162|NCT00316199|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683163|NCT00316199|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683164|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683165|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683166|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683167|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683168|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683169|NCT00316199|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
683170|NCT00316186|B1|Baseline|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683171|NCT00316186|P1|Participant Flow|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683172|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683173|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683174|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683175|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683176|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683177|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683178|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683179|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683180|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683181|NCT00316186|E1|Reported Event|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
683182|NCT00316173|B3|Baseline|Total|Total of all reporting groups
683183|NCT00316173|B2|Baseline|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683184|NCT00316173|B1|Baseline|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
683185|NCT00316173|P2|Participant Flow|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683186|NCT00316173|P1|Participant Flow|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
683187|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683188|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683189|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683190|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683191|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683192|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683193|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683889|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
683194|NCT00316173|E2|Reported Event|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
683195|NCT00316173|E1|Reported Event|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
683196|NCT00316121|B3|Baseline|Total|Total of all reporting groups
683197|NCT00316121|B2|Baseline|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
683198|NCT00316121|B1|Baseline|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
683199|NCT00316121|P2|Participant Flow|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
683200|NCT00316121|P1|Participant Flow|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
683201|NCT00316121|O2|Outcome|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
683202|NCT00316121|O1|Outcome|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
683203|NCT00316121|E2|Reported Event|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
683204|NCT00316121|E1|Reported Event|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
683205|NCT00316082|B6|Baseline|Total|Total of all reporting groups
683206|NCT00316082|B5|Baseline|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683207|NCT00316082|B4|Baseline|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
683208|NCT00316082|B3|Baseline|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
683209|NCT00316082|B2|Baseline|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
683210|NCT00316082|B1|Baseline|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
683211|NCT00316082|P5|Participant Flow|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683212|NCT00316082|P4|Participant Flow|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
683213|NCT00316082|P3|Participant Flow|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
683214|NCT00316082|P2|Participant Flow|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
683215|NCT00316082|P1|Participant Flow|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
683216|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683217|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
683218|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
683219|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
683220|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
683221|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683222|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
683223|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
683224|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
683225|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
683226|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683227|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
683228|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
683229|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
683230|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
683231|NCT00316082|O2|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683232|NCT00316082|O1|Outcome|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
683233|NCT00316082|O4|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683234|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
683235|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
683236|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
683237|NCT00316082|E5|Reported Event|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
683238|NCT00316082|E4|Reported Event|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
683239|NCT00316082|E3|Reported Event|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
683240|NCT00316082|E2|Reported Event|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
683241|NCT00316082|E1|Reported Event|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
683242|NCT00316017|B4|Baseline|Total|Total of all reporting groups
683243|NCT00316017|B3|Baseline|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683244|NCT00316017|B2|Baseline|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683245|NCT00316017|B1|Baseline|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683246|NCT00316017|P3|Participant Flow|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683247|NCT00316017|P2|Participant Flow|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683248|NCT00316017|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683249|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683250|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683251|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683252|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683253|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683254|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683255|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683256|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683257|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683258|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683259|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683260|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683261|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683262|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683263|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683264|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683265|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683266|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683267|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683268|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683269|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683270|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683271|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683272|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683273|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683274|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683275|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683276|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683277|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683278|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683279|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683280|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683281|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683282|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683283|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683284|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683285|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683286|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683287|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683288|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683289|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683290|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683291|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683292|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683293|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683294|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683295|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683296|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683297|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683298|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683299|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683300|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683301|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683302|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683303|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683304|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683305|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683306|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683307|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683308|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683309|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683310|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683311|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683312|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683313|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683314|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683315|NCT00316017|E3|Reported Event|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
683316|NCT00316017|E2|Reported Event|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
683317|NCT00316017|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
683318|NCT00316004|B4|Baseline|Total|Total of all reporting groups
683319|NCT00316004|B3|Baseline|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683320|NCT00316004|B2|Baseline|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683321|NCT00316004|B1|Baseline|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683322|NCT00316004|P3|Participant Flow|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683323|NCT00316004|P2|Participant Flow|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683324|NCT00316004|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683325|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683326|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683327|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683328|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683329|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683330|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683331|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683332|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683333|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683334|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683335|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683336|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683337|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683338|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683339|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683340|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683341|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683342|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683343|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683344|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683464|NCT00315627|O1|Outcome|Islet Transplantation|Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
683345|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683346|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683347|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683348|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683349|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683350|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683351|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683352|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683353|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683354|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683355|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683356|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683357|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683358|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683359|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683360|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683361|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683362|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683363|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683364|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683365|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683366|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683367|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683368|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683369|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683370|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683371|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683388|NCT00315822|P2|Participant Flow|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
703829|NCT00252967|O1|Outcome|Placebo|
683372|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683373|NCT00316004|E3|Reported Event|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683374|NCT00316004|E2|Reported Event|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683375|NCT00316004|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
683376|NCT00315939|B3|Baseline|Total|Total of all reporting groups
683377|NCT00315939|B2|Baseline|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months.
683378|NCT00315939|B1|Baseline|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months.
683379|NCT00315939|P2|Participant Flow|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
683380|NCT00315939|P1|Participant Flow|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
683381|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.~Each level continued for 3 months.~IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.~IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
683382|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.~Each level continued for 3 months.~IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.~IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
683383|NCT00315939|E2|Reported Event|IBMF-2|IBMF-2 retains level 2, but the HHC asks subjects to provide symptom ratings when BG (blood glucose) is low and at an equal number of matching euglycemic readings. From these data, the HHC estimates a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
683384|NCT00315939|E1|Reported Event|IBMF-1|IBMF-1 will use the OneTouch® UltraSmart® glucometer (LifeScan, Milpitas, CA) to collect routine SMBG data and the subject transfers the blood glucose (BG) value into a hand-held computer (HHC) for processing. As the subject checks BG on a daily basis, the IBMF-1 software calculates an estimate of HbA1c, acute risk for hypoglycemia and chronic risk for hypoglycemia. This information will be presented back to the subject. Specifically, (i) alarms for immediate action if BG<50 mg/dL is registered; (ii) a running HbA1c estimate (71); (iii) a warning to be more careful and measure BG more frequently over the next 24 hours if elevated acute risk for hypoglycemia is found, and (iv) an indication of the subject's chronic risk for hypoglycemia in one of 4 categories (minimal, low, moderate, and high). At moderate and high risk the subject will be prompted to consider altering his/her behavior. HbA1c and chronic risk change slowly (2-3 weeks), while acute risk can change daily.
683385|NCT00315822|B3|Baseline|Total|Total of all reporting groups
683386|NCT00315822|B2|Baseline|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
683387|NCT00315822|B1|Baseline|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
683389|NCT00315822|P1|Participant Flow|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
683390|NCT00315822|O2|Outcome|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
683391|NCT00315822|O1|Outcome|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
683392|NCT00315822|E2|Reported Event|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
683393|NCT00315822|E1|Reported Event|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
683394|NCT00315731|B1|Baseline|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683395|NCT00315731|P1|Participant Flow|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683396|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683397|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683398|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683399|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683400|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683401|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683423|NCT00315705|P1|Participant Flow|Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2. > Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
683462|NCT00315627|O1|Outcome|Islet Transplantation|"Islet Alone Transplantation under Alentuzumab (Campath1H) induction.~Islet transplantation: Islet transplantation"
683402|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683403|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683404|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683405|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683406|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683407|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683408|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683409|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683410|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683424|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
683463|NCT00315627|O1|Outcome|Islet Transplantation|Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
707773|NCT00236184|O1|Outcome|Placebo|
683411|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683412|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683413|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683414|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683415|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683416|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683417|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683418|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683419|NCT00315731|E1|Reported Event|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
683420|NCT00315705|B3|Baseline|Total|Total of all reporting groups
683421|NCT00315705|B2|Baseline|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
683422|NCT00315705|B1|Baseline|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
683425|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
683890|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
683426|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
683427|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
683428|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
683429|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
683430|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
683431|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
683432|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
683433|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
683434|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
683435|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
683436|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
683437|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683438|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683439|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683440|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
683441|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
683442|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683443|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683444|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683445|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
683446|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
683447|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683448|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683449|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683450|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
683451|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
683452|NCT00315705|E7|Reported Event|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
683453|NCT00315705|E6|Reported Event|Phase 1 - Total|All participants from Cohorts 1-5 in Phase 1
683454|NCT00315705|E5|Reported Event|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683455|NCT00315705|E4|Reported Event|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683456|NCT00315705|E3|Reported Event|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
683457|NCT00315705|E2|Reported Event|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
683458|NCT00315705|E1|Reported Event|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
683459|NCT00315627|B1|Baseline|Islet Transplantation|Islet transplantation: Islet transplantation
683460|NCT00315627|P1|Participant Flow|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
683461|NCT00315627|O1|Outcome|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
683465|NCT00315627|O1|Outcome|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
683466|NCT00315627|E1|Reported Event|Islet Transplantation|Islet transplantation alone under alentuzumab (Campath1H) induction.
683467|NCT00315614|B1|Baseline|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
683468|NCT00315614|P1|Participant Flow|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
683469|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
683470|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
683471|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
683472|NCT00315614|O1|Outcome|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
683473|NCT00315614|E1|Reported Event|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
683474|NCT00315588|B1|Baseline|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
683475|NCT00315588|P1|Participant Flow|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
683476|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant
683477|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
683478|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant.
683479|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
683480|NCT00315588|E1|Reported Event|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
683481|NCT00315458|B3|Baseline|Total|Total of all reporting groups
683482|NCT00315458|B2|Baseline|Double-blind BTDS|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
683483|NCT00315458|B1|Baseline|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
683484|NCT00315458|P4|Participant Flow|Extension Phase BTDS 5/10/20|Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed.
683485|NCT00315458|P3|Participant Flow|Run-in Period BTDS 5/10/20|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
683486|NCT00315458|P2|Participant Flow|Double-blind BTDS 10/20|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
683487|NCT00315458|P1|Participant Flow|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
683488|NCT00315458|O4|Outcome|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
683489|NCT00315458|O3|Outcome|Run-in Period|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
683490|NCT00315458|O2|Outcome|Double-blind BTDS|Test treatment buprenoprhine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
683491|NCT00315458|O1|Outcome|Double-blind Placebo|Reference treatment placebo 10 or 20 applied for 7-day wear
683492|NCT00315458|E4|Reported Event|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
683493|NCT00315458|E3|Reported Event|Run-in Period|Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear
683494|NCT00315458|E2|Reported Event|Double-blind BTDS 10/20|Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
683495|NCT00315458|E1|Reported Event|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
683496|NCT00315445|B4|Baseline|Total|Total of all reporting groups
683497|NCT00315445|B3|Baseline|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683498|NCT00315445|B2|Baseline|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683499|NCT00315445|B1|Baseline|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683500|NCT00315445|P3|Participant Flow|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683501|NCT00315445|P2|Participant Flow|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683502|NCT00315445|P1|Participant Flow|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683503|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683504|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683505|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683506|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683507|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683508|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683891|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
683509|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683510|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683511|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683512|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683513|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683514|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683515|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683516|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683517|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683518|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683519|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683520|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683521|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683522|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683523|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683524|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683525|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683526|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683527|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683528|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683529|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683530|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683531|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683532|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683533|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683534|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683535|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683536|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683537|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683538|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683539|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683540|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683541|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683542|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683543|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683544|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683545|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683546|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683547|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683548|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683549|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683550|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683551|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683552|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683553|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683554|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683555|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683556|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683557|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683558|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683559|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683560|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683561|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683562|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683563|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683564|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683565|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683566|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683567|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683568|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683569|NCT00315445|E3|Reported Event|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
683570|NCT00315445|E2|Reported Event|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
683571|NCT00315445|E1|Reported Event|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
683572|NCT00315341|B3|Baseline|Total|Total of all reporting groups
683573|NCT00315341|B2|Baseline|Methadone|
683574|NCT00315341|B1|Baseline|Buprenorphine/Nx|
683575|NCT00315341|P2|Participant Flow|Methadone|The mean dose of methadone was 93.2 mg.
683576|NCT00315341|P1|Participant Flow|Buprenorphine/Nx|Participants received medication for 24 weeks in the active phase of the study. The mean dose of buprenorphine was 22.3 mg. Blood samples for measurement of liver function were taken at baseline and at Weeks 1, 2, 4 8, 12, 16, 20, and 24 with follow-up at Week 32.
683577|NCT00315341|O2|Outcome|Methadone|
683578|NCT00315341|O1|Outcome|Buprenorphine/Nx|
683579|NCT00315341|E2|Reported Event|Methadone|For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant’s clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
683580|NCT00315341|E1|Reported Event|Buprenorphine/Nx|For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant’s clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
683581|NCT00315328|B5|Baseline|Total|Total of all reporting groups
683582|NCT00315328|B4|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683583|NCT00315328|B3|Baseline|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683584|NCT00315328|B2|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683585|NCT00315328|B1|Baseline|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683586|NCT00315328|P4|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683587|NCT00315328|P3|Participant Flow|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683588|NCT00315328|P2|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683589|NCT00315328|P1|Participant Flow|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683590|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683591|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683592|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683593|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683594|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683595|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683881|NCT00314353|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab|
683596|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683597|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683598|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683599|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683600|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683601|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683602|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683603|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683604|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683605|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683606|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683607|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683608|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683609|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683610|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683611|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683612|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683613|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683614|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683615|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683616|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683617|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683618|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683619|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683620|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683621|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683622|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683623|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683624|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683625|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683626|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683627|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683628|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683629|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683882|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
683630|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683631|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683632|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683633|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683634|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683635|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683636|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683637|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683638|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683639|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683640|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683641|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683642|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683643|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683644|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683645|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683646|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683647|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683648|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683649|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683650|NCT00315328|E4|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
683651|NCT00315328|E3|Reported Event|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
683652|NCT00315328|E2|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
683653|NCT00315328|E1|Reported Event|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
683654|NCT00315302|B5|Baseline|Total|Total of all reporting groups
683655|NCT00315302|B4|Baseline|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683656|NCT00315302|B3|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683657|NCT00315302|B2|Baseline|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683658|NCT00315302|B1|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683659|NCT00315302|P4|Participant Flow|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683660|NCT00315302|P3|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683661|NCT00315302|P2|Participant Flow|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683662|NCT00315302|P1|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683663|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683664|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683883|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
683884|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
683665|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683666|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683667|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683668|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683669|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683670|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683671|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683672|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683673|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683674|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683675|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683676|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683677|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683678|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683679|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683680|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683681|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683682|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683683|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683684|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683685|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683686|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683687|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683688|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683689|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683690|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683691|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683692|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683693|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683694|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683695|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683696|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683697|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683698|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683699|NCT00315302|E4|Reported Event|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
683700|NCT00315302|E3|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
683701|NCT00315302|E2|Reported Event|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683885|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
683702|NCT00315302|E1|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
683703|NCT00315146|B5|Baseline|Total|Total of all reporting groups
683704|NCT00315146|B4|Baseline|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
683705|NCT00315146|B3|Baseline|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
683706|NCT00315146|B2|Baseline|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
683707|NCT00315146|B1|Baseline|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
683708|NCT00315146|P4|Participant Flow|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
683709|NCT00315146|P3|Participant Flow|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
683710|NCT00315146|P2|Participant Flow|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
683711|NCT00315146|P1|Participant Flow|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
683712|NCT00315146|O4|Outcome|Hypocaloric Diet,Resistance Training, Pioglitazone/Actos™|"Pioglitazone~Resistance exercise training to maximize muscle power~Hypocaloric diet"
683713|NCT00315146|O3|Outcome|Hypocaloric Diet and a PPAR- γ Agonist (Pioglitazone/Actos™)|"Pioglitazone~Hypocaloric diet"
683714|NCT00315146|O2|Outcome|Hypocaloric Diet, Resist. Training to Maximize Power, Placebo|"Resistance exercise training to maximize muscle power~Hypocaloric diet~Placebo"
683715|NCT00315146|O1|Outcome|Hypocaloric Diet (and Placebo)|"Hypocaloric diet~Placebo"
683716|NCT00315146|O4|Outcome|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
683717|NCT00315146|O3|Outcome|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
683718|NCT00315146|O2|Outcome|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
683719|NCT00315146|O1|Outcome|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
683720|NCT00315146|E4|Reported Event|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
683721|NCT00315146|E3|Reported Event|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
683722|NCT00315146|E2|Reported Event|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
683821|NCT00314808|B1|Baseline|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683886|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
683723|NCT00315146|E1|Reported Event|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
683724|NCT00315120|B5|Baseline|Total|Total of all reporting groups
683725|NCT00315120|B4|Baseline|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
683726|NCT00315120|B3|Baseline|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
683727|NCT00315120|B2|Baseline|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
683728|NCT00315120|B1|Baseline|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
683729|NCT00315120|P4|Participant Flow|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
683730|NCT00315120|P3|Participant Flow|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
683731|NCT00315120|P2|Participant Flow|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
683732|NCT00315120|P1|Participant Flow|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
683733|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683734|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683735|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683736|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683737|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683738|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683739|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683740|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683741|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683742|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683743|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683744|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683745|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683746|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683747|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683748|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683749|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683750|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683751|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683752|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683753|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683754|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683755|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683756|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683757|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683758|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683759|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683760|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683761|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683762|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683763|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683764|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683765|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683766|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683767|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683768|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683769|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683770|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683771|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683772|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683773|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound therapy
683774|NCT00315120|O1|Outcome|Active UST|Active ultrasound therapy
683775|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
683776|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
683777|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683778|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683779|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683780|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683781|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683782|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683783|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
683784|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
683785|NCT00315120|E4|Reported Event|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound therapy
683786|NCT00315120|E3|Reported Event|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound therapy
683787|NCT00315120|E2|Reported Event|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound therapy
683788|NCT00315120|E1|Reported Event|OMT + UST|Active osteopathic manipulation and active ultrasound therapy
683789|NCT00315055|B3|Baseline|Total|Total of all reporting groups
683790|NCT00315055|B2|Baseline|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683791|NCT00315055|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683792|NCT00315055|P2|Participant Flow|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683793|NCT00315055|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683794|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683795|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683796|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683797|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683798|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683799|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683800|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683801|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683802|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683803|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683804|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX® PEDIATRIC|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683805|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683806|NCT00315055|E2|Reported Event|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683807|NCT00315055|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
683808|NCT00314951|B3|Baseline|Total|Total of all reporting groups
683809|NCT00314951|B2|Baseline|Fidaxomicin|200 mg administered twice daily (q12hr)
683810|NCT00314951|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
683811|NCT00314951|P2|Participant Flow|Fidaxomicin|200 mg administered twice daily (q12hr)
683812|NCT00314951|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
683813|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
683814|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
683815|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
683816|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
683817|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
683818|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
683819|NCT00314951|E2|Reported Event|Fidaxomicin|200 mg administered twice daily (q12hr)
683820|NCT00314951|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
683887|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
683822|NCT00314808|P1|Participant Flow|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683823|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683824|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683825|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683826|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683827|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683828|NCT00314808|E1|Reported Event|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
683829|NCT00314574|B3|Baseline|Total|Total of all reporting groups
683830|NCT00314574|B2|Baseline|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683831|NCT00314574|B1|Baseline|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683832|NCT00314574|P2|Participant Flow|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683833|NCT00314574|P1|Participant Flow|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683834|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683835|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683836|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683837|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683838|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683839|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683857|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683840|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683841|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683842|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683843|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683844|NCT00314574|E2|Reported Event|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683845|NCT00314574|E1|Reported Event|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
683846|NCT00314366|B3|Baseline|Total|Total of all reporting groups
683847|NCT00314366|B2|Baseline|Control|"Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683848|NCT00314366|B1|Baseline|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683849|NCT00314366|P2|Participant Flow|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683850|NCT00314366|P1|Participant Flow|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683851|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683852|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683853|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683854|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683855|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683856|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683879|NCT00314353|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab|
683880|NCT00314353|P2|Participant Flow|Capecitabine, Irinotecan, Bevacizumab|
742882|NCT00092677|O2|Outcome|Placebo|
683858|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683859|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683860|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683861|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683862|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683863|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683864|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683865|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683866|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683867|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683868|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683869|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683870|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683871|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683872|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683873|NCT00314366|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
683874|NCT00314366|O1|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683875|NCT00314366|E2|Reported Event|Control|"Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
683876|NCT00314366|E1|Reported Event|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
683877|NCT00314353|B3|Baseline|Total|Total of all reporting groups
683878|NCT00314353|B2|Baseline|Capecitabine, Irinotecan, Bevacizumab|
683892|NCT00314353|E2|Reported Event|Capecitabine, Irinotecan, Bevacizumab|
683893|NCT00314353|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab|
683894|NCT00314340|B1|Baseline|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
683895|NCT00314340|P1|Participant Flow|All Participants|All participants were randomized to receive the ER morphine tablets, 45 mg, hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg, or placebo in a 3 way cross over design.
683896|NCT00314340|O3|Outcome|Placebo|
683897|NCT00314340|O2|Outcome|Hydrocodone 30 mg Plus N-acetyl-para-aminophenol 975 mg|These findings all argue against the hypothesis that the hydrocodone product induced a greater euphoric or reinforcing effect than that of ER morphine.
683898|NCT00314340|O1|Outcome|ER Morphine Tablets, 45mg|Scores of the 5 Addiction Research Center Inventory dimensions did not change significantly between baseline and 300 min under any treatment condition.
683899|NCT00314340|E1|Reported Event|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
683900|NCT00314327|B1|Baseline|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
683901|NCT00314327|P1|Participant Flow|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
683902|NCT00314327|O1|Outcome|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
683903|NCT00314327|O1|Outcome|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
683904|NCT00314327|E1|Reported Event|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
683905|NCT00314262|B1|Baseline|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
683906|NCT00314262|P1|Participant Flow|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
683907|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
683908|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
683909|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
683910|NCT00314262|E1|Reported Event|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
683911|NCT00314249|B3|Baseline|Total|Total of all reporting groups
683912|NCT00314249|B2|Baseline|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683913|NCT00314249|B1|Baseline|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683914|NCT00314249|P2|Participant Flow|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683915|NCT00314249|P1|Participant Flow|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683916|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683917|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683918|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683919|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683920|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683921|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683922|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683923|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683924|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683925|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683926|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683927|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683928|NCT00314249|E2|Reported Event|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
683929|NCT00314249|E1|Reported Event|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
683930|NCT00314236|B3|Baseline|Total|Total of all reporting groups
683931|NCT00314236|B2|Baseline|Control|Microfracture alone
683932|NCT00314236|B1|Baseline|Experimental|BST-CarGel applied to a Microfractured lesion
683933|NCT00314236|P2|Participant Flow|Control|Microfracture alone
683934|NCT00314236|P1|Participant Flow|Experimental|BST-CarGel applied to a Microfractured lesion
683935|NCT00314236|O2|Outcome|Control|Microfracture alone
683936|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
683937|NCT00314236|O2|Outcome|Control|Microfracture alone
683938|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
683939|NCT00314236|O2|Outcome|Control|Microfracture alone
683940|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
683941|NCT00314236|O2|Outcome|Control|Microfracture alone
683942|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
683943|NCT00314236|E2|Reported Event|Control|Microfracture alone
683944|NCT00314236|E1|Reported Event|Experimental|BST-CarGel applied to a Microfractured lesion
683945|NCT00314145|B3|Baseline|Total|Total of all reporting groups
683946|NCT00314145|B2|Baseline|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
683947|NCT00314145|B1|Baseline|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
683948|NCT00314145|P2|Participant Flow|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
683949|NCT00314145|P1|Participant Flow|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
683950|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
683951|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
683952|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
683953|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
683954|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
683955|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
683956|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
683957|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
683958|NCT00314145|E2|Reported Event|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
683959|NCT00314145|E1|Reported Event|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
683960|NCT00314132|B3|Baseline|Total|Total of all reporting groups
683961|NCT00314132|B2|Baseline|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
683962|NCT00314132|B1|Baseline|Placebo|Participants received a single injection of placebo on Day 0.
683963|NCT00314132|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
683964|NCT00314132|P1|Participant Flow|Placebo|Participants received a single injection of placebo on Day 0.
683965|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
683966|NCT00314132|O1|Outcome|Placebo|Participants received a single injection of placebo on Day 0.
683967|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
683968|NCT00314132|O1|Outcome|Placebo|All subjects received a single injection of placebo on Day 0.
683969|NCT00314132|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
683970|NCT00314132|E1|Reported Event|Placebo|Participants received a single injection of placebo on Day 0.
683971|NCT00314106|B3|Baseline|Total|Total of all reporting groups
683972|NCT00314106|B2|Baseline|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
683973|NCT00314106|B1|Baseline|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
683974|NCT00314106|P2|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
683975|NCT00314106|P1|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
683976|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
683977|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
684000|NCT00313846|P2|Participant Flow|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
684001|NCT00313846|P1|Participant Flow|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
684002|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
683978|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
683979|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
683980|NCT00314106|E2|Reported Event|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
683981|NCT00314106|E1|Reported Event|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
683982|NCT00313911|B3|Baseline|Total|Total of all reporting groups
683983|NCT00313911|B2|Baseline|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683984|NCT00313911|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683985|NCT00313911|P2|Participant Flow|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683986|NCT00313911|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683987|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683988|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683989|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683990|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683991|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683992|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683993|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683994|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683995|NCT00313911|E2|Reported Event|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683996|NCT00313911|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
683997|NCT00313846|B3|Baseline|Total|Total of all reporting groups
683998|NCT00313846|B2|Baseline|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
683999|NCT00313846|B1|Baseline|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
684003|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
684004|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
684005|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
684006|NCT00313846|E3|Reported Event|Open-label Run-in Period BTDS 5, 10, or 20|Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase.
684007|NCT00313846|E2|Reported Event|Double-blind BTDS 5, 10, or 20|Test treatments in the double-blind phase
684008|NCT00313846|E1|Reported Event|Double-blind Placebo Patch 5, 10, or 20|Reference treatment in the double-blind phase
684009|NCT00313820|B3|Baseline|Total|Total of all reporting groups
684010|NCT00313820|B2|Baseline|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684011|NCT00313820|B1|Baseline|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684012|NCT00313820|P2|Participant Flow|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684013|NCT00313820|P1|Participant Flow|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684014|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684015|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684016|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684017|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684018|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684019|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684020|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684312|NCT00313144|O1|Outcome|Year Prior to Baseline|
684313|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
684021|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684022|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684023|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684024|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684025|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684026|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684027|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684028|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684029|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684030|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684031|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684032|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684033|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684034|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684035|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684036|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684037|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684038|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684039|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684040|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684041|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684042|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684043|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684044|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684045|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684046|NCT00313820|E2|Reported Event|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684047|NCT00313820|E1|Reported Event|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
684048|NCT00313781|B3|Baseline|Total|Total of all reporting groups
684049|NCT00313781|B2|Baseline|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684073|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684050|NCT00313781|B1|Baseline|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684051|NCT00313781|P3|Participant Flow|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684052|NCT00313781|P2|Participant Flow|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684053|NCT00313781|P1|Participant Flow|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.
684054|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684055|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684056|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684057|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684058|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684059|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684060|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684061|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684062|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684063|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684064|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684065|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684066|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684067|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684068|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684069|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684070|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684071|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684072|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684314|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
684074|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684075|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684076|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684077|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684078|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684079|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684080|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684081|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684082|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684083|NCT00313781|E3|Reported Event|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
684084|NCT00313781|E2|Reported Event|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
684085|NCT00313781|E1|Reported Event|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
684086|NCT00313716|B7|Baseline|Total|Total of all reporting groups
684087|NCT00313716|B6|Baseline|Placebo/TT10 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl
684088|NCT00313716|B5|Baseline|Epo2/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl
684089|NCT00313716|B4|Baseline|Epo1/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl
684090|NCT00313716|B3|Baseline|Placebo/TT7 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl
684091|NCT00313716|B2|Baseline|Epo2/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
684092|NCT00313716|B1|Baseline|Epo1/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl
684093|NCT00313716|P6|Participant Flow|Placebo/TT10 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl
684094|NCT00313716|P5|Participant Flow|Epo2/TT10 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
684095|NCT00313716|P4|Participant Flow|Epo1/TT10 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
684096|NCT00313716|P3|Participant Flow|Placebo/TT7 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
684097|NCT00313716|P2|Participant Flow|Epo2/TT7 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
684098|NCT00313716|P1|Participant Flow|Epo1/TT7 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
684099|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 group, Epo2/TT10 group, and Placebo/TT10 group combined)
684100|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
684101|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
684102|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
684103|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
684104|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
684105|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
684106|NCT00313716|O2|Outcome|Epo2 Group|Patients received 500 IU/kg within 6 hrs after injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
684107|NCT00313716|O1|Outcome|Epo1 Group|Patients received 500 IU/kg erythropoietin within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
684108|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
684109|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
684110|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
684111|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
684112|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
684113|NCT00313716|O2|Outcome|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
684114|NCT00313716|O1|Outcome|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
684115|NCT00313716|E5|Reported Event|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
684116|NCT00313716|E4|Reported Event|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
684117|NCT00313716|E3|Reported Event|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
684118|NCT00313716|E2|Reported Event|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
684119|NCT00313716|E1|Reported Event|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
684120|NCT00313703|B5|Baseline|Total|Total of all reporting groups
684121|NCT00313703|B4|Baseline|Other|Met other International Headache Society criteria
684122|NCT00313703|B3|Baseline|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
684123|NCT00313703|B2|Baseline|Tension-type Headache|met International Headache Society tension-type headache criteria
684124|NCT00313703|B1|Baseline|Migraine|met International Headache Society migraine criteria
684125|NCT00313703|P4|Participant Flow|Other|Met other International Headache Society criteria
684126|NCT00313703|P3|Participant Flow|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
684127|NCT00313703|P2|Participant Flow|Tension-type Headache|met International Headache Society tension-type headache criteria
684128|NCT00313703|P1|Participant Flow|Migraine|met International Headache Society migraine criteria
684129|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
684130|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
684131|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
684132|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
684133|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
684134|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
684135|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
684136|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
684137|NCT00313703|E4|Reported Event|Other|Met other International Headache Society criteria
684138|NCT00313703|E3|Reported Event|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
684139|NCT00313703|E2|Reported Event|Tension-type Headache|met International Headache Society tension-type headache criteria
684140|NCT00313703|E1|Reported Event|Migraine|met International Headache Society migraine criteria
684141|NCT00313612|B3|Baseline|Total|Total of all reporting groups
684142|NCT00313612|B2|Baseline|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684143|NCT00313612|B1|Baseline|Treatment Stratum I: (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684144|NCT00313612|P2|Participant Flow|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684145|NCT00313612|P1|Participant Flow|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684146|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684147|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684148|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684149|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684150|NCT00313612|E2|Reported Event|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684151|NCT00313612|E1|Reported Event|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
684152|NCT00313586|B5|Baseline|Total|Total of all reporting groups
684153|NCT00313586|B4|Baseline|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
684154|NCT00313586|B3|Baseline|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
684155|NCT00313586|B2|Baseline|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
684156|NCT00313586|B1|Baseline|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
684157|NCT00313586|P4|Participant Flow|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
684158|NCT00313586|P3|Participant Flow|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
684159|NCT00313586|P2|Participant Flow|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
684160|NCT00313586|P1|Participant Flow|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
684161|NCT00313586|O4|Outcome|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
684162|NCT00313586|O3|Outcome|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
684163|NCT00313586|O2|Outcome|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
684164|NCT00313586|O1|Outcome|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
684165|NCT00313586|E2|Reported Event|Arm B (Azacitidine + Entinostat)|Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
684166|NCT00313586|E1|Reported Event|Arm A (Azacitidine)|Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
684167|NCT00313443|B1|Baseline|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684168|NCT00313443|P1|Participant Flow|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684169|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684170|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684171|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684172|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684173|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684174|NCT00313443|E1|Reported Event|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
684175|NCT00313313|B4|Baseline|Total|Total of all reporting groups
684192|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684176|NCT00313313|B3|Baseline|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
684177|NCT00313313|B2|Baseline|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684178|NCT00313313|B1|Baseline|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684179|NCT00313313|P3|Participant Flow|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
684180|NCT00313313|P2|Participant Flow|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684181|NCT00313313|P1|Participant Flow|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684182|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
684183|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684184|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684185|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
684186|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684187|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684188|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
684189|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684190|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684191|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
684214|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684193|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684194|NCT00313313|E3|Reported Event|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684195|NCT00313313|E2|Reported Event|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
684196|NCT00313313|E1|Reported Event|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
684197|NCT00313300|B6|Baseline|Total|Total of all reporting groups
684198|NCT00313300|B5|Baseline|Apixaban 20 mg QD|"Tablet of apixaban, oral, for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated."
684199|NCT00313300|B4|Baseline|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated"
684200|NCT00313300|B3|Baseline|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684201|NCT00313300|B2|Baseline|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684202|NCT00313300|B1|Baseline|Placebo|Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684203|NCT00313300|P5|Participant Flow|Apixaban 20 mg QD|"Phase B of the Study: Tablet of Apixaban 20 mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the apixaban 20 mg QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
684204|NCT00313300|P4|Participant Flow|Apixaban 10mg BID|"Phase B of the Study: Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the 10 mg BID QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the 10 mg BID apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
684205|NCT00313300|P3|Participant Flow|Apixaban 10mg QD|In both Phase A and Phase B of the study: Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
684206|NCT00313300|P2|Participant Flow|Apixaban 2.5mg BID|In both Phase A and Phase B of the study: Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
684207|NCT00313300|P1|Participant Flow|Placebo|Study was conducted in 2 Phases (A and B). A tablet of Placebo along with ≤ 165 mg of aspirin was given daily for 26 weeks. 75 mg of clopidogrel once a day (QD) was allowed at the investigator’s discretion. After 547 subjects were randomized to Phase A, an independent Data and Safety Monitoring Board (DSMB) recommended expanding the randomization to 2 higher doses of apixaban (10 mg BID and 20 mg QD) in Phase B of the study. Approximately 6 months after the start of Phase B, the DSMB recommended apixaban high dose groups be terminated due to excess bleeding in those participants receiving aspirin and clopidogrel concomitantly with high dose apixaban. Treatment and any new randomization into these 2 groups was halted, while randomization and treatment in the placebo and lower dose apixaban groups continued. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
684208|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684209|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684210|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684211|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684212|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684213|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684309|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
684310|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684215|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684216|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684217|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684218|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684219|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684220|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684221|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684222|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684223|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684224|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684225|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684226|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684227|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo, oral, for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684228|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684229|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
684230|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684231|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684232|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684233|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684234|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684235|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684236|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684237|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684238|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684239|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684240|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684241|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684242|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684243|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684244|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684245|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684246|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684247|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
684311|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684248|NCT00313300|E8|Reported Event|Phase B Placebo|Participants treated with at least one dose of Placebo during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
684249|NCT00313300|E7|Reported Event|Phase B Apixaban 2.5mg BID|Participants treated with at least one dose of 2.5 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
684250|NCT00313300|E6|Reported Event|Phase B Apixaban 20mg QD|Participants treated with at least one dose of 20 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
684251|NCT00313300|E5|Reported Event|Phase B Apixaban 10mg QD|Participants treated with at least one dose of 10 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
684252|NCT00313300|E4|Reported Event|Phase B Apixaban 10mg BID|Participants treated with at least one dose of 10 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
684253|NCT00313300|E3|Reported Event|Phase A+B Placebo|Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
684254|NCT00313300|E2|Reported Event|Phase A+B Apixaban 2.5mg BID|Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
684255|NCT00313300|E1|Reported Event|Phase A+B Apixaban 10mg QD|Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
684256|NCT00313209|B3|Baseline|Total|Total of all reporting groups
684257|NCT00313209|B2|Baseline|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684258|NCT00313209|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684259|NCT00313209|P2|Participant Flow|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684260|NCT00313209|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684261|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684262|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684263|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684264|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684265|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684266|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684267|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684268|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684269|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684270|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684271|NCT00313209|E2|Reported Event|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684272|NCT00313209|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
684273|NCT00313170|B4|Baseline|Total|Total of all reporting groups
684274|NCT00313170|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
684275|NCT00313170|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
684276|NCT00313170|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
684277|NCT00313170|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
684278|NCT00313170|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
684279|NCT00313170|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
684280|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
684281|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
684282|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
684283|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
684284|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
684285|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
684286|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
684287|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
684288|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
684289|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
684290|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
684291|NCT00313170|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
684292|NCT00313170|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
684293|NCT00313170|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
684294|NCT00313144|B1|Baseline|Overall Study|
684295|NCT00313144|P1|Participant Flow|Overall Study|Participants were treated with ARALAST according to dose and frequency of infusions recommended by their physician.
684296|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
684297|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
684298|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
684299|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
684300|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
684301|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
684302|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
684303|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
684304|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
684305|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
684306|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
684307|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
684308|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
684315|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684316|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684317|NCT00313144|O1|Outcome|Year Prior to Baseline|
684318|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
684319|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
684320|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684321|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684322|NCT00313144|O1|Outcome|Year Prior to Baseline|
684323|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
684324|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
684325|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684326|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684327|NCT00313144|O1|Outcome|Year Prior to Baseline|
684328|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
684329|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
684330|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
684331|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
684332|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
684333|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
684334|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
684335|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
684336|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
684337|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
684338|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684339|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684340|NCT00313144|O1|Outcome|Year Prior to Baseline|
684341|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
684342|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
684343|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
684344|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
684345|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
684346|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
684347|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684348|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684349|NCT00313144|O1|Outcome|Baseline|
684350|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
684351|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684352|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684353|NCT00313144|O1|Outcome|Baseline|
684354|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
684355|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684356|NCT00313144|O1|Outcome|Baseline|
684357|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684358|NCT00313144|O1|Outcome|Baseline|
684359|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684360|NCT00313144|O1|Outcome|Baseline|
684361|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684362|NCT00313144|O1|Outcome|Baseline|
684363|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684364|NCT00313144|O1|Outcome|Baseline|
684365|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684366|NCT00313144|O1|Outcome|Baseline|
684367|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684368|NCT00313144|O1|Outcome|Baseline|
684369|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684370|NCT00313144|O1|Outcome|Baseline|
684371|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684372|NCT00313144|O1|Outcome|Baseline|
684373|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684374|NCT00313144|O1|Outcome|Baseline|
684375|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
684376|NCT00313144|O1|Outcome|Baseline|
684377|NCT00313144|E1|Reported Event|Overall Study|
684378|NCT00313014|B4|Baseline|Total|Total of all reporting groups
684379|NCT00313014|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
684380|NCT00313014|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684381|NCT00313014|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684382|NCT00313014|P3|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
684383|NCT00313014|P2|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684384|NCT00313014|P1|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684385|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
684386|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684387|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684388|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
684389|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684390|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684391|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
684392|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684393|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684394|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
684395|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684396|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684397|NCT00313014|E4|Reported Event|Open-label Run-in Period, BTDS 10/20|Open-label BTDS 10 or 20 mcg/h applied for 7-day wear
684398|NCT00313014|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
684399|NCT00313014|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684400|NCT00313014|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684401|NCT00312923|B3|Baseline|Total|Total of all reporting groups
684402|NCT00312923|B2|Baseline|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
684403|NCT00312923|B1|Baseline|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
684404|NCT00312923|P2|Participant Flow|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
684405|NCT00312923|P1|Participant Flow|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
684406|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
684407|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
684408|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
684409|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
684410|NCT00312923|E2|Reported Event|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
684411|NCT00312923|E1|Reported Event|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
684412|NCT00312897|B3|Baseline|Total|Total of all reporting groups
684413|NCT00312897|B2|Baseline|Omega 3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
684414|NCT00312897|B1|Baseline|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
684415|NCT00312897|P2|Participant Flow|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. Acids: 10 wk treatment period"
684416|NCT00312897|P1|Participant Flow|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
684417|NCT00312897|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
684418|NCT00312897|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
684419|NCT00312897|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
684420|NCT00312897|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
684421|NCT00312897|E2|Reported Event|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
684422|NCT00312897|E1|Reported Event|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
684423|NCT00312884|B3|Baseline|Total|Total of all reporting groups
684424|NCT00312884|B2|Baseline|Intervention Arm|Received daily home monitoring
684425|NCT00312884|B1|Baseline|Usual Care|Recieved usual follow-up care
684426|NCT00312884|P2|Participant Flow|Usual Care|Received usual hospital care with no Telemonitoring
684575|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684576|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684427|NCT00312884|P1|Participant Flow|Intervention Arm|Recieved home telemonitoring daily HomMed Telemonitoring System: The HomeMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
684428|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684429|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684430|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684431|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684432|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684433|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684434|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684435|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
684436|NCT00312884|E2|Reported Event|Intervention Arm|Recieved telemonitoring daily via the HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
684437|NCT00312884|E1|Reported Event|Usual Care|Recieved usual hospital care
684438|NCT00312858|B3|Baseline|Total|Total of all reporting groups
684439|NCT00312858|B2|Baseline|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684440|NCT00312858|B1|Baseline|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684441|NCT00312858|P2|Participant Flow|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684442|NCT00312858|P1|Participant Flow|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684443|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684444|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684445|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684446|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684447|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684448|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684449|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684450|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684451|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684452|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684453|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684454|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684455|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684456|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684457|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684458|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684459|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684460|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684461|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684462|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684463|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684464|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684465|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684466|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684467|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684468|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684469|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684470|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684577|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684471|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684472|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684473|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684474|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684475|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684476|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684477|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684478|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684479|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684480|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684481|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684482|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684483|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684484|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684485|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684486|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684487|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684488|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684489|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684490|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684578|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684491|NCT00312858|E2|Reported Event|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
684492|NCT00312858|E1|Reported Event|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
684493|NCT00312845|B3|Baseline|Total|Total of all reporting groups
684494|NCT00312845|B2|Baseline|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
684495|NCT00312845|B1|Baseline|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
684496|NCT00312845|P2|Participant Flow|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
684497|NCT00312845|P1|Participant Flow|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
684498|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
684499|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
684500|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
684501|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
684502|NCT00312845|E2|Reported Event|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
684503|NCT00312845|E1|Reported Event|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
684504|NCT00312728|B1|Baseline|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684505|NCT00312728|P1|Participant Flow|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684506|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684507|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684508|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684509|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684510|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684511|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684512|NCT00312728|E1|Reported Event|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
684513|NCT00312572|B3|Baseline|Total|Total of all reporting groups
684514|NCT00312572|B2|Baseline|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684515|NCT00312572|B1|Baseline|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684516|NCT00312572|P2|Participant Flow|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684517|NCT00312572|P1|Participant Flow|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684518|NCT00312572|O3|Outcome|Combined Total|Combined percentages from BTDS 10/20 and BTDS 20
684519|NCT00312572|O2|Outcome|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684520|NCT00312572|O1|Outcome|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684579|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684521|NCT00312572|E3|Reported Event|Open-label Run-in Period - Vicodin|N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily “average pain over the last 24 hours” score of 0 = none or 1 = mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.
684522|NCT00312572|E2|Reported Event|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684523|NCT00312572|E1|Reported Event|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
684524|NCT00312494|B4|Baseline|Total|Total of all reporting groups
684525|NCT00312494|B3|Baseline|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684526|NCT00312494|B2|Baseline|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684527|NCT00312494|B1|Baseline|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684528|NCT00312494|P3|Participant Flow|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684529|NCT00312494|P2|Participant Flow|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684530|NCT00312494|P1|Participant Flow|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684531|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684532|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684533|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684534|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684535|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684536|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684537|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684538|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684539|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684540|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684541|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684542|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684543|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684544|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684545|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684546|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684547|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684548|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684549|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684550|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684551|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684552|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684553|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684554|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684555|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684556|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684557|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684558|NCT00312494|E3|Reported Event|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
684559|NCT00312494|E2|Reported Event|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
684560|NCT00312494|E1|Reported Event|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
684561|NCT00312377|B3|Baseline|Total|Total of all reporting groups
684562|NCT00312377|B2|Baseline|Placebo Plus Docetaxel|Placebo plus docetaxel
684563|NCT00312377|B1|Baseline|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684564|NCT00312377|P2|Participant Flow|Placebo Plus Docetaxel|Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
684565|NCT00312377|P1|Participant Flow|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
684566|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684567|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684568|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684569|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684570|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684571|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684572|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684573|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684574|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684580|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684581|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684582|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
684583|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684584|NCT00312377|E2|Reported Event|Placebo Plus Docetaxel|Placebo plus docetaxel
684585|NCT00312377|E1|Reported Event|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
684586|NCT00312338|B3|Baseline|Total|Total of all reporting groups
684587|NCT00312338|B2|Baseline|Healthy Subjects|Healthy Subjects
684588|NCT00312338|B1|Baseline|Infected Patients|Infected Patients
684589|NCT00312338|P2|Participant Flow|Healthy Subjects|Healthy Subjects
684590|NCT00312338|P1|Participant Flow|Infected Patients|Infected Patients
684591|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
684592|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
684593|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
684594|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
684595|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
684596|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
684597|NCT00312338|E2|Reported Event|Healthy Subjects|Healthy Subjects
684598|NCT00312338|E1|Reported Event|Infected Patients|Infected Patients
684599|NCT00312221|B4|Baseline|Total|Total of all reporting groups
684600|NCT00312221|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
684601|NCT00312221|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684602|NCT00312221|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684603|NCT00312221|P4|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
684604|NCT00312221|P3|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684605|NCT00312221|P2|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684606|NCT00312221|P1|Participant Flow|Run-in Period|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
684607|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
684608|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684609|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684610|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
684611|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684612|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684613|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
684614|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684615|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684616|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
684617|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
684618|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
684619|NCT00312221|E4|Reported Event|Run-in, Open-label BTDS 10 and 20|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
684620|NCT00312221|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours) during the 12-week double-blind phase.
684621|NCT00312221|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
684622|NCT00312221|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear during the 12-week double-blind phase
684623|NCT00312208|B3|Baseline|Total|Total of all reporting groups
684624|NCT00312208|B2|Baseline|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
684625|NCT00312208|B1|Baseline|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
684626|NCT00312208|P2|Participant Flow|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
684627|NCT00312208|P1|Participant Flow|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
684628|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
684700|NCT00311376|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
684701|NCT00311376|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
684629|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
684630|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
684631|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
684632|NCT00312208|E2|Reported Event|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
684633|NCT00312208|E1|Reported Event|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
684634|NCT00312195|B3|Baseline|Total|Total of all reporting groups
684635|NCT00312195|B2|Baseline|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
684636|NCT00312195|B1|Baseline|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
684637|NCT00312195|P2|Participant Flow|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
684638|NCT00312195|P1|Participant Flow|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
684639|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
684640|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
684641|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
684642|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
684643|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
684644|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
684645|NCT00312195|O3|Outcome|Total|Placebo and BTDS combined.
684646|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
684647|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
684648|NCT00312195|E3|Reported Event|Open-label Run-in Period BTDS 5, 10 or 20|Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
684649|NCT00312195|E2|Reported Event|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
684650|NCT00312195|E1|Reported Event|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
684651|NCT00311766|B3|Baseline|Total|Total of all reporting groups
684652|NCT00311766|B2|Baseline|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
684653|NCT00311766|B1|Baseline|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
684654|NCT00311766|P2|Participant Flow|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
684655|NCT00311766|P1|Participant Flow|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
684656|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
684657|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
684658|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
684659|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
684660|NCT00311766|E2|Reported Event|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
684661|NCT00311766|E1|Reported Event|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
684662|NCT00311584|B3|Baseline|Total|Total of all reporting groups
684663|NCT00311584|B2|Baseline|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684702|NCT00311376|P3|Participant Flow|Placebo|Normal saline (placebo)
684703|NCT00311376|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
684704|NCT00311376|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
684705|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
684664|NCT00311584|B1|Baseline|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684665|NCT00311584|P2|Participant Flow|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684666|NCT00311584|P1|Participant Flow|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684667|NCT00311584|O2|Outcome|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684668|NCT00311584|O1|Outcome|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684669|NCT00311584|E2|Reported Event|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684670|NCT00311584|E1|Reported Event|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
684671|NCT00311402|B3|Baseline|Total|Total of all reporting groups
684672|NCT00311402|B2|Baseline|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684673|NCT00311402|B1|Baseline|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684674|NCT00311402|P2|Participant Flow|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684675|NCT00311402|P1|Participant Flow|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684676|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684677|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684678|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684679|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684680|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684681|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684682|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684683|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684684|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684685|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684686|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684687|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684688|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684689|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684690|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684691|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684692|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684693|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684694|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684695|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684696|NCT00311402|E2|Reported Event|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
684697|NCT00311402|E1|Reported Event|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
684698|NCT00311376|B4|Baseline|Total|Total of all reporting groups
684699|NCT00311376|B3|Baseline|Placebo|Normal saline (placebo)
686957|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
684706|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
684707|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
684708|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
684709|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
684710|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
684711|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
684712|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
684713|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
684714|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
684715|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
684716|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
684717|NCT00311376|E3|Reported Event|Placebo|Normal saline (placebo)
684718|NCT00311376|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
684719|NCT00311376|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
684720|NCT00311363|B4|Baseline|Total|Total of all reporting groups
684721|NCT00311363|B3|Baseline|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
684722|NCT00311363|B2|Baseline|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
684723|NCT00311363|B1|Baseline|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
684724|NCT00311363|P3|Participant Flow|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
684725|NCT00311363|P2|Participant Flow|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
684726|NCT00311363|P1|Participant Flow|Single-blind (SB) GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
684727|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684728|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684729|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684730|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684731|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684732|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684733|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684734|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684735|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684736|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684737|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684738|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684739|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684740|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684741|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684742|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684743|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684744|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
688045|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
684745|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684746|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684747|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684748|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684749|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684750|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684751|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684752|NCT00311363|O2|Outcome|DB GEn 1200mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684753|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684754|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684755|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684756|NCT00311363|O2|Outcome|GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684757|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684758|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684759|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684760|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684761|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684762|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684763|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684764|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684765|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684766|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684767|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684768|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684769|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684770|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684771|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684772|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684773|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684774|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684775|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684776|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684777|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684778|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684779|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684780|NCT00311363|E3|Reported Event|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
684781|NCT00311363|E2|Reported Event|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
684782|NCT00311363|E1|Reported Event|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
684783|NCT00311311|B3|Baseline|Total|Total of all reporting groups
684784|NCT00311311|B2|Baseline|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684785|NCT00311311|B1|Baseline|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684786|NCT00311311|P2|Participant Flow|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to cyclosporine (CsA) (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684787|NCT00311311|P1|Participant Flow|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter [ng/mL] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to [>=] 500 milligram per day [mg/day]) or mycophenolate sodium (MPS) (>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684788|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684789|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684790|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684791|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684792|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684804|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684793|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684794|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684795|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684796|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684797|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684798|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684799|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684800|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684801|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684802|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684803|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684894|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684805|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684806|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684807|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684808|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684809|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684810|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684811|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684812|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684813|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684814|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684815|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684895|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684816|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684817|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684818|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684819|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684820|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684821|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684822|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684823|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684824|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684825|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684826|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684861|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684896|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684827|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684828|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684829|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684830|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684831|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684832|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684833|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684834|NCT00311311|E2|Reported Event|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
684835|NCT00311311|E1|Reported Event|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
684836|NCT00311181|B1|Baseline|Group 1|
684837|NCT00311181|P1|Participant Flow|Group 1|
684838|NCT00311181|O1|Outcome|Group 1|
684839|NCT00311181|O1|Outcome|Group 1|
684840|NCT00311181|O1|Outcome|Group 1|
684841|NCT00311181|E1|Reported Event|Group 1|
684842|NCT00311155|B1|Baseline|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
684843|NCT00311155|P1|Participant Flow|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
684862|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684844|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
684845|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
684846|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
684847|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
684848|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
684849|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
684850|NCT00311155|E1|Reported Event|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
684851|NCT00310856|B4|Baseline|Total|Total of all reporting groups
684852|NCT00310856|B3|Baseline|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684853|NCT00310856|B2|Baseline|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684854|NCT00310856|B1|Baseline|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684855|NCT00310856|P3|Participant Flow|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).~Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684856|NCT00310856|P2|Participant Flow|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
684857|NCT00310856|P1|Participant Flow|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
684858|NCT00310856|O3|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684859|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684860|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
685021|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
684863|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684864|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684865|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684866|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
684867|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684868|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684869|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684870|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684871|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684872|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
684873|NCT00310856|E3|Reported Event|MenC-CRM_12M_MenACWY-CRM_18M|Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)
684874|NCT00310856|E2|Reported Event|MenACWY-CRM_12M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
684875|NCT00310856|E1|Reported Event|MenACWY-CRM_6-12M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
684876|NCT00310817|B5|Baseline|Total|Total of all reporting groups
684877|NCT00310817|B4|Baseline|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
684878|NCT00310817|B3|Baseline|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
684879|NCT00310817|B2|Baseline|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
684880|NCT00310817|B1|Baseline|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684881|NCT00310817|P4|Participant Flow|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
684882|NCT00310817|P3|Participant Flow|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
684883|NCT00310817|P2|Participant Flow|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
684884|NCT00310817|P1|Participant Flow|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684885|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
684886|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
684887|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
684888|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684889|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
684890|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
684891|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
684892|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684893|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
688046|NCT00301262|O3|Outcome|DB Placebo Week 8|
684897|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684898|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684899|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
684900|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
684901|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
684902|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
684903|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MEnACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
684904|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MEnACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
684905|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
684906|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
684907|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
684908|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
684909|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
684910|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
684911|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
684912|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
684913|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
684914|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
684915|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) (12-35M12- )|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
684916|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
684917|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
684918|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
684919|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
684920|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
684921|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
684922|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
684923|NCT00310817|O2|Outcome|MenACWY-CRM (Ad-)12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684924|NCT00310817|O1|Outcome|MenACWY-CRM (Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684925|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684926|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684927|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684928|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
684929|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
684930|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine with on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684931|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
684932|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684933|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
685022|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
684934|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684935|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
684936|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
684937|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
684938|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
684939|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
684940|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) on day 169 (6 months after first vaccination).
684941|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
684942|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
684943|NCT00310817|O4|Outcome|MeMenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
684944|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
684945|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
684946|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
684947|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
684948|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
684949|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
684950|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
684951|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
684952|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
684953|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
684954|NCT00310817|O1|Outcome|MenACWY-CRM(Ad)- (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
684955|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
684956|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
684957|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
684958|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
684959|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
684960|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
684961|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
684962|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337
684963|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.
684964|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
684965|NCT00310817|E4|Reported Event|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
684966|NCT00310817|E3|Reported Event|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 169 or day 337.
684967|NCT00310817|E2|Reported Event|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
684968|NCT00310817|E1|Reported Event|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+)vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
684969|NCT00310804|B3|Baseline|Total|Total of all reporting groups
684970|NCT00310804|B2|Baseline|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
685023|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
684971|NCT00310804|B1|Baseline|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
684972|NCT00310804|P2|Participant Flow|TIV Group|Subjects in this group received one dose of Egg derived Trivalent Subunit Influenza Vaccine (TIV).
684973|NCT00310804|P1|Participant Flow|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
684974|NCT00310804|O4|Outcome|TIV Group Day 23 to Day 181|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
684975|NCT00310804|O3|Outcome|TIV Group Day 1 to Day 22|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
684976|NCT00310804|O2|Outcome|cTIV (Combined) Day 23 to Day 181|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
684977|NCT00310804|O1|Outcome|cTIV (Combined) Day 1 to Day 22|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot 1, Lot2 or Lot3).
684978|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
684979|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
684980|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
684981|NCT00310804|O2|Outcome|cTIV_lot2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
684982|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
684983|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
684984|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
684985|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from lot 3.
684986|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
684987|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
684988|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
684989|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
684990|NCT00310804|O3|Outcome|cTIV_lot 3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
684991|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
684992|NCT00310804|O1|Outcome|cTIV_lot 1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
684993|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg-Derived Trivalent Subunit Influenza Vaccine(TIV).
684994|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
684995|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
684996|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
684997|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
684998|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
684999|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
685000|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
685001|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
685002|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
685003|NCT00310804|E2|Reported Event|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
685004|NCT00310804|E1|Reported Event|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
685005|NCT00310791|B3|Baseline|Total|Total of all reporting groups
685006|NCT00310791|B2|Baseline|Active|
685007|NCT00310791|B1|Baseline|Placebo|
685008|NCT00310791|P2|Participant Flow|Active|
685009|NCT00310791|P1|Participant Flow|Placebo|
685010|NCT00310791|O2|Outcome|Active|DHEA+HRT
685011|NCT00310791|O1|Outcome|Placebo|Sugar Pill
685012|NCT00310791|E2|Reported Event|Active|
685013|NCT00310791|E1|Reported Event|Placebo|
685014|NCT00310466|B3|Baseline|Total|Total of all reporting groups
685015|NCT00310466|B2|Baseline|Placebo|Corresponding placebo for sublingual administration
685016|NCT00310466|B1|Baseline|SLITone Birch|Birch pollen extract for sublingual administration
685017|NCT00310466|P2|Participant Flow|Placebo|Corresponding placebo for sublingual administration
685018|NCT00310466|P1|Participant Flow|SLITone Birch|Birch pollen extract for sublingual administration
685019|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
685020|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
685024|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
685025|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
685026|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
685027|NCT00310466|E2|Reported Event|Placebo|Corresponding placebo for sublingual administration
685028|NCT00310466|E1|Reported Event|SLITone Birch|Birch pollen extract for sublingual administration
685029|NCT00310440|B3|Baseline|Total|Total of all reporting groups
685030|NCT00310440|B2|Baseline|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685031|NCT00310440|B1|Baseline|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685032|NCT00310440|P2|Participant Flow|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685033|NCT00310440|P1|Participant Flow|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685034|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685035|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685036|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685037|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685038|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685039|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685040|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685041|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685042|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685043|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685044|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685045|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685086|NCT00310401|O2|Outcome|Saline|Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
685087|NCT00310401|O1|Outcome|Albuterol|Albuterol: 5 mg nebulized q4h
685046|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685047|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685048|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685049|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685050|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685051|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685052|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685053|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685054|NCT00310440|E2|Reported Event|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
685055|NCT00310440|E1|Reported Event|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
685056|NCT00310427|B3|Baseline|Total|Total of all reporting groups
685057|NCT00310427|B2|Baseline|Placebo|Subjects received placebo orally on a daily basis.
685058|NCT00310427|B1|Baseline|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685059|NCT00310427|P2|Participant Flow|Placebo|Subjects received placebo orally on a daily basis.
685060|NCT00310427|P1|Participant Flow|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685061|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685062|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685063|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685064|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685065|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685066|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685067|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685068|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685069|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685070|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685071|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685072|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685073|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685074|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685075|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
685076|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685077|NCT00310427|E2|Reported Event|Placebo|Subjects received placebo orally on a daily basis.
685078|NCT00310427|E1|Reported Event|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
685079|NCT00310401|B3|Baseline|Total|Total of all reporting groups
685080|NCT00310401|B2|Baseline|Saline|
685081|NCT00310401|B1|Baseline|Albuterol|
685082|NCT00310401|P2|Participant Flow|Saline|
685083|NCT00310401|P1|Participant Flow|Albuterol|
685084|NCT00310401|O2|Outcome|Saline|Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
685085|NCT00310401|O1|Outcome|Albuterol|Albuterol: 5 mg nebulized q4h
685088|NCT00310401|O2|Outcome|Saline|Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
685089|NCT00310401|O1|Outcome|Albuterol|Albuterol: 5 mg nebulized q4h
685090|NCT00310401|O2|Outcome|Saline|Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
685091|NCT00310401|O1|Outcome|Albuterol|Albuterol: 5 mg nebulized q4h
685092|NCT00310401|O2|Outcome|Saline|Saline every 4 hours by nebulization
685093|NCT00310401|O1|Outcome|Albuterol|Albuterol 5 mg every 4 hour by nebulization
685094|NCT00310401|E2|Reported Event|Saline|
685095|NCT00310401|E1|Reported Event|Albuterol|
685096|NCT00310375|B3|Baseline|Total|Total of all reporting groups
685097|NCT00310375|B2|Baseline|Retigabine in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.
685098|NCT00310375|B1|Baseline|Placebo in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.
685099|NCT00310375|P3|Participant Flow|Safety Follow-up Continuation Phase (SFUCP)|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
685100|NCT00310375|P2|Participant Flow|Retigabine in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.
685101|NCT00310375|P1|Participant Flow|Placebo in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.
685102|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685103|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685104|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685105|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685106|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685107|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685108|NCT00310375|O1|Outcome|Retigabine SFUCP|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
685109|NCT00310375|O1|Outcome|Retigabine SFUCP|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
685128|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
688047|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
685110|NCT00310375|O1|Outcome|Retigabine SFUCP|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
685111|NCT00310375|O1|Outcome|Retigabine SFUCP|Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
685112|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685113|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685114|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685115|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685116|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685117|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685118|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685119|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685120|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685121|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685122|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685123|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685124|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685125|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685126|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685127|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685261|NCT00309738|E2|Reported Event|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
685262|NCT00309738|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685263|NCT00309608|B6|Baseline|Total|Total of all reporting groups
685129|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685130|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685131|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685132|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685133|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685134|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685135|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685136|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685137|NCT00310375|O1|Outcome|Overall Study|
685138|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685139|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685140|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685141|NCT00310375|E1|Reported Event|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
685142|NCT00310362|B4|Baseline|Total|Total of all reporting groups
685143|NCT00310362|B3|Baseline|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
685144|NCT00310362|B2|Baseline|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures..
685145|NCT00310362|B1|Baseline|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
685146|NCT00310362|P3|Participant Flow|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
685147|NCT00310362|P2|Participant Flow|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
685148|NCT00310362|P1|Participant Flow|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
685149|NCT00310362|O3|Outcome|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
685150|NCT00310362|O2|Outcome|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
685151|NCT00310362|O1|Outcome|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
685152|NCT00310362|E3|Reported Event|IVR7|Arm 2 (IVR3) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
685264|NCT00309608|B5|Baseline|Glimepiride|Patients randomized to receive treatment with Glimepiride
688048|NCT00301262|O1|Outcome|DB Viagra Week 8|
685153|NCT00310362|E2|Reported Event|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
685154|NCT00310362|E1|Reported Event|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
685155|NCT00310310|B3|Baseline|Total|Total of all reporting groups
685156|NCT00310310|B2|Baseline|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685157|NCT00310310|B1|Baseline|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685158|NCT00310310|P2|Participant Flow|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685159|NCT00310310|P1|Participant Flow|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685160|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685161|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685162|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685163|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685164|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685165|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685166|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685167|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685168|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685169|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685170|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685171|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685172|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685173|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685174|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685175|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685176|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685177|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685178|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685179|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685180|NCT00310310|E2|Reported Event|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
685181|NCT00310310|E1|Reported Event|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
685182|NCT00310076|B1|Baseline|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
685183|NCT00310076|P1|Participant Flow|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
685184|NCT00310076|O1|Outcome|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
685185|NCT00310076|E1|Reported Event|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
685186|NCT00309985|B3|Baseline|Total|Total of all reporting groups
685187|NCT00309985|B2|Baseline|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685188|NCT00309985|B1|Baseline|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685189|NCT00309985|P2|Participant Flow|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685268|NCT00309608|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
685190|NCT00309985|P1|Participant Flow|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685191|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685192|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685193|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685194|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685195|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685196|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685197|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685198|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685199|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685200|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685201|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685202|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685203|NCT00309985|E2|Reported Event|Arm B|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
685204|NCT00309985|E1|Reported Event|Arm A|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
685205|NCT00309946|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
685206|NCT00309946|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
685207|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
685208|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
685209|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
685210|NCT00309946|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
685265|NCT00309608|B4|Baseline|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
685266|NCT00309608|B3|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
685267|NCT00309608|B2|Baseline|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
685211|NCT00309907|B1|Baseline|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
685212|NCT00309907|P1|Participant Flow|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
685213|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|Regimen A
685214|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|Regimen A
685215|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|Regimen A
685216|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|Regimen A
685217|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|Regimen A
685218|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
685219|NCT00309907|E1|Reported Event|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
685220|NCT00309777|B5|Baseline|Total|Total of all reporting groups
685221|NCT00309777|B4|Baseline|Simvastatin 40 mg|Simvastatn 40 mg once daily
685222|NCT00309777|B3|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
685223|NCT00309777|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg once daily
685224|NCT00309777|B1|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
685225|NCT00309777|P4|Participant Flow|Simvastatin 40 mg|Simvastatn 40 mg once daily
685226|NCT00309777|P3|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
685227|NCT00309777|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg once daily
685228|NCT00309777|P1|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
685229|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
685230|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
685231|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
685232|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
685233|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
685234|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
685235|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
685236|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
685237|NCT00309777|E4|Reported Event|Simvastatin 40 mg|Simvastatn 40 mg once daily
685238|NCT00309777|E3|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
685239|NCT00309777|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg once daily
685240|NCT00309777|E1|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
685241|NCT00309751|B3|Baseline|Total|Total of all reporting groups
685242|NCT00309751|B2|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
685243|NCT00309751|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685244|NCT00309751|P2|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
685245|NCT00309751|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685246|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
685247|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685248|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
685249|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685250|NCT00309751|E2|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
685251|NCT00309751|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685252|NCT00309738|B3|Baseline|Total|Total of all reporting groups
685253|NCT00309738|B2|Baseline|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
685254|NCT00309738|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685255|NCT00309738|P2|Participant Flow|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
685256|NCT00309738|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685257|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
685258|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685259|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
685260|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
685269|NCT00309608|P5|Participant Flow|Glimepiride|Patients randomized to receive treatment with Glimepiride
685270|NCT00309608|P4|Participant Flow|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
685271|NCT00309608|P3|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
685272|NCT00309608|P2|Participant Flow|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
685273|NCT00309608|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
685274|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
685275|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
685276|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
685277|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
685278|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
685279|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
685280|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
685281|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
685282|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
685283|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
685284|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
685285|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
685286|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
685287|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
685288|NCT00309608|E5|Reported Event|Glimepiride|Patients randomized to receive treatment with Glimepiride
685289|NCT00309608|E4|Reported Event|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
685290|NCT00309608|E3|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
685291|NCT00309608|E2|Reported Event|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
685292|NCT00309608|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
685293|NCT00309465|B7|Baseline|Total|Total of all reporting groups
685294|NCT00309465|B6|Baseline|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
685295|NCT00309465|B5|Baseline|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
685296|NCT00309465|B4|Baseline|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
685297|NCT00309465|B3|Baseline|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual fasting blood glucose range was > or = 150 mg/dl.
685298|NCT00309465|B2|Baseline|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery.
685299|NCT00309465|B1|Baseline|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
685300|NCT00309465|P6|Participant Flow|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose value was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
685301|NCT00309465|P5|Participant Flow|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
685302|NCT00309465|P4|Participant Flow|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
685303|NCT00309465|P3|Participant Flow|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose value was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was > or = 150 mg/dl.
685304|NCT00309465|P2|Participant Flow|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
685305|NCT00309465|P1|Participant Flow|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
685306|NCT00309465|O6|Outcome|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of their usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of their usual insulin glargine dose if midpoint of self-reported usual fasting blood glucose ragne was > or = 150 mg/dl
685307|NCT00309465|O5|Outcome|Call Physician (Insulin Glargine Plus Bolus Group|Subjects called their own physicians for the insulin glargine dose to administer on the evening before surgery
685308|NCT00309465|O4|Outcome|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects self-administered 80% of the usual insulin glargine dose on the evening before surgery
685309|NCT00309465|O3|Outcome|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of their usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was > or = 150 mg/dl
685310|NCT00309465|O2|Outcome|Call Physician (Insulin Glargine Only Group)|Subjects called their own physicians for insulin glargine dose on the evening before surgery
685311|NCT00309465|O1|Outcome|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
685312|NCT00309465|E6|Reported Event|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was <150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was < or =150 mg/dl.
685313|NCT00309465|E5|Reported Event|Call Physician (Insulin Glargine Plus Bolus Group)|Subjects called physician for the insulin glargine dose to administer on the evening before surgery.
685314|NCT00309465|E4|Reported Event|Take 80% (Insuling Glargine Plus Bolus Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
685315|NCT00309465|E3|Reported Event|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose > or =150 mg/dl
685316|NCT00309465|E2|Reported Event|Call Physician (Insulin Glargine Only Group)|Subjects called physician for the insulin glargine dose on the evening before surgery.
685317|NCT00309465|E1|Reported Event|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
685318|NCT00309452|B3|Baseline|Total|Total of all reporting groups
685319|NCT00309452|B2|Baseline|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685320|NCT00309452|B1|Baseline|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685321|NCT00309452|P2|Participant Flow|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685322|NCT00309452|P1|Participant Flow|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685323|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685324|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685325|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685326|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685327|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685328|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685329|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685330|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685331|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685332|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685333|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685334|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685335|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685336|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685337|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685338|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685339|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685380|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685381|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685340|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685341|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685342|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685343|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685344|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685345|NCT00309452|E2|Reported Event|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
685346|NCT00309452|E1|Reported Event|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
685347|NCT00309387|B3|Baseline|Total|Total of all reporting groups
685348|NCT00309387|B2|Baseline|Placebo|
685349|NCT00309387|B1|Baseline|Treatment|
685350|NCT00309387|P2|Participant Flow|Placebo|
685351|NCT00309387|P1|Participant Flow|Treatment|
685352|NCT00309387|O2|Outcome|Placebo|Placebo
685353|NCT00309387|O1|Outcome|Treatment|Centrum
685354|NCT00309387|O2|Outcome|Placebo|Placebo
685355|NCT00309387|O1|Outcome|Treatment|Centrum
685356|NCT00309387|O2|Outcome|Placebo|Placebo
685357|NCT00309387|O1|Outcome|Treatment|Centrum
685358|NCT00309387|O2|Outcome|Placebo|placebo
685359|NCT00309387|O1|Outcome|Treatment|Centrum
685360|NCT00309387|O2|Outcome|Placebo|Placebo
685361|NCT00309387|O1|Outcome|Treatment|Centrum
685362|NCT00309387|O2|Outcome|Placebo|Placebo
685363|NCT00309387|O1|Outcome|Treatment|Centrum
685364|NCT00309387|E2|Reported Event|Placebo|
685365|NCT00309387|E1|Reported Event|Treatment|
685366|NCT00309244|B3|Baseline|Total|Total of all reporting groups
685367|NCT00309244|B2|Baseline|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685368|NCT00309244|B1|Baseline|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685369|NCT00309244|P2|Participant Flow|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.
685370|NCT00309244|P1|Participant Flow|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
685371|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685372|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685373|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685374|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685375|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685376|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685377|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685378|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685379|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685382|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685383|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685384|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685385|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685386|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685387|NCT00309244|E2|Reported Event|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
685388|NCT00309244|E1|Reported Event|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
685389|NCT00308997|B3|Baseline|Total|Total of all reporting groups
685390|NCT00308997|B2|Baseline|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685391|NCT00308997|B1|Baseline|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685392|NCT00308997|P2|Participant Flow|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685393|NCT00308997|P1|Participant Flow|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685394|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685395|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685396|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685397|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685398|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685399|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685400|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685401|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685402|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685457|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685458|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685459|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685403|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685404|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685405|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685406|NCT00308997|E2|Reported Event|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685407|NCT00308997|E1|Reported Event|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
685408|NCT00308737|B4|Baseline|Total|Total of all reporting groups
685409|NCT00308737|B3|Baseline|Non-diabetes|Subjects without abnormalities in glucose control
685410|NCT00308737|B2|Baseline|Usual Care|Usual care
685411|NCT00308737|B1|Baseline|Technosphere® Insulin|Technosphere Insulin
685412|NCT00308737|P3|Participant Flow|Non-diabetes|Subjects without abnormalities in glucose control
685413|NCT00308737|P2|Participant Flow|Usual Care|Usual care may consist of oral anti-diabetic medications, basal insulin, subcutaneous prandial insulin, or any combination of the previous.
685414|NCT00308737|P1|Participant Flow|Technosphere® Insulin|Technosphere Insulin with or without basal insulin, or oral anti-diabetic medications, or any combination of the previous.
685415|NCT00308737|O2|Outcome|Usual Care|Usual care
685416|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685417|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685418|NCT00308737|O2|Outcome|Usual Care|Usual care
685419|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685420|NCT00308737|O2|Outcome|Usual Care|Usual care
685421|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685422|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685423|NCT00308737|O2|Outcome|Usual Care|Usual care
685424|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685425|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685426|NCT00308737|O2|Outcome|Usual Care|Usual care
685427|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685428|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685429|NCT00308737|O2|Outcome|Usual Care|Usual care
685430|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685431|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685432|NCT00308737|O2|Outcome|Usual Care|Usual care
685433|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685434|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685435|NCT00308737|O2|Outcome|Usual Care|Usual care
685436|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685437|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685438|NCT00308737|O2|Outcome|Usual Care|Usual care
685439|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685440|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
685441|NCT00308737|O2|Outcome|Usual Care|Usual care
685442|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685443|NCT00308737|O2|Outcome|Usual Care|Usual care
685444|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685445|NCT00308737|O2|Outcome|Usual Care|Usual care
685446|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
685447|NCT00308737|E3|Reported Event|Non-diabetes|Subjects without abnormalities in glucose control
685448|NCT00308737|E2|Reported Event|Usual Care|Usual care (taking insulin)
685449|NCT00308737|E1|Reported Event|Technosphere® Insulin|Technosphere Insulin
685450|NCT00308711|B4|Baseline|Total|Total of all reporting groups
685451|NCT00308711|B3|Baseline|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685452|NCT00308711|B2|Baseline|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685453|NCT00308711|B1|Baseline|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685454|NCT00308711|P3|Participant Flow|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685455|NCT00308711|P2|Participant Flow|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685456|NCT00308711|P1|Participant Flow|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685460|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685461|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685462|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685463|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685464|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685465|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685466|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685467|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685468|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685469|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685470|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685471|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685472|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685473|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685474|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685475|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685476|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685477|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685478|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685479|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685480|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685481|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685482|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685483|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685484|NCT00308711|E3|Reported Event|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
685485|NCT00308711|E2|Reported Event|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
685486|NCT00308711|E1|Reported Event|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
685487|NCT00308620|B4|Baseline|Total|Total of all reporting groups
685488|NCT00308620|B3|Baseline|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
685489|NCT00308620|B2|Baseline|Placebo|Placebo once daily for 8 weeks
685490|NCT00308620|B1|Baseline|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
685491|NCT00308620|P3|Participant Flow|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
685492|NCT00308620|P2|Participant Flow|Placebo|Placebo once daily for 8 weeks
685493|NCT00308620|P1|Participant Flow|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
685494|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
685495|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 500mg orally once daily x 8 weeks
685496|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
685497|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
685498|NCT00308620|E3|Reported Event|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
685499|NCT00308620|E2|Reported Event|Placebo|Placebo once daily for 8 weeks
685500|NCT00308620|E1|Reported Event|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
685501|NCT00308581|B1|Baseline|Overall|Overall Induction
685502|NCT00308581|P3|Participant Flow|Overall|Overall Induction
685503|NCT00308581|P2|Participant Flow|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685504|NCT00308581|P1|Participant Flow|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685505|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685506|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685507|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685508|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685509|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685510|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685511|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685512|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685513|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685514|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685515|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685516|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685517|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685518|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685519|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685520|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685521|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685522|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685523|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685524|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685525|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685526|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685527|NCT00308581|O1|Outcome|Overall|Overall Induction
685528|NCT00308581|O1|Outcome|Overall|Overall Induction
685529|NCT00308581|O1|Outcome|Overall|Overall Induction
685530|NCT00308581|O1|Outcome|Overall|Overall Induction
685531|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685532|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685533|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685534|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685535|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685536|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685537|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685538|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685539|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685540|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685541|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685542|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685543|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685544|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685545|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685546|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685547|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685548|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685549|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685550|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685551|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685552|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685553|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685554|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685555|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685556|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685557|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685558|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685559|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685560|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685561|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685562|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685563|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685564|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685565|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685566|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685567|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685568|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685569|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685570|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685571|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685572|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685573|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685574|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685575|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685576|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685577|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685578|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685579|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685580|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685581|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685582|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685583|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685584|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685585|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685586|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685587|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685588|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685589|NCT00308581|O1|Outcome|Overall|Overall Induction
685590|NCT00308581|O1|Outcome|Overall|Overall Induction
685591|NCT00308581|O1|Outcome|Overall|Overall Induction
685592|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685593|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685594|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685595|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685596|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685597|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685598|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685599|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685600|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685601|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685602|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685603|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685604|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685605|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685606|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685607|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685608|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685609|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685610|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685611|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685612|NCT00308581|O1|Outcome|Overall|Overall Induction
685613|NCT00308581|O1|Outcome|Overall|Overall Induction
685614|NCT00308581|O1|Outcome|Overall|Overall Induction
685615|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685616|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685617|NCT00308581|O1|Outcome|Overall|Overall Induction
685618|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685619|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685620|NCT00308581|O1|Outcome|Overall|Overall Induction
685621|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
685622|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
685623|NCT00308581|O1|Outcome|Overall|Overall Induction
685624|NCT00308581|E3|Reported Event|Induction Phase|Overall population in the Induction phase + safety follow-up period following induction phase.
685625|NCT00308581|E2|Reported Event|Q2W Regimen|Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
685626|NCT00308581|E1|Reported Event|Q4W Regimen|Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
685627|NCT00308555|B3|Baseline|Total|Total of all reporting groups
685628|NCT00308555|B2|Baseline|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for chronic pain
685629|NCT00308555|B1|Baseline|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain
685630|NCT00308555|P2|Participant Flow|Oxycontin|Patients using oxycodone hydrochloride (OxyContin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
685631|NCT00308555|P1|Participant Flow|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
685632|NCT00308555|O2|Outcome|Oxycodone|Participants on oxycodone treatment
685633|NCT00308555|O1|Outcome|MS Contin|Participants on morphine treatment
685634|NCT00308555|E2|Reported Event|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for cancer pain
685635|NCT00308555|E1|Reported Event|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for cancer pain
685636|NCT00308516|B3|Baseline|Total|Total of all reporting groups
685637|NCT00308516|B2|Baseline|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685669|NCT00308230|B3|Baseline|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
685670|NCT00308230|B2|Baseline|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
685671|NCT00308230|B1|Baseline|Control|Structurally normal heart without heart disease
685672|NCT00308230|P3|Participant Flow|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
686092|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
685638|NCT00308516|B1|Baseline|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685639|NCT00308516|P2|Participant Flow|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685640|NCT00308516|P1|Participant Flow|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685641|NCT00308516|O2|Outcome|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685642|NCT00308516|O1|Outcome|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685643|NCT00308516|E2|Reported Event|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685644|NCT00308516|E1|Reported Event|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
685645|NCT00308308|B3|Baseline|Total|Total of all reporting groups
685646|NCT00308308|B2|Baseline|Insulin Aspart + Insulin Glargine|Comparator
685647|NCT00308308|B1|Baseline|TI + Insulin Glargine|TI + Insulin glargine
685648|NCT00308308|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Comparator
685649|NCT00308308|P1|Participant Flow|TI + Insulin Glargine|TI + Insulin glargine
685650|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685651|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685652|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685653|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685654|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685655|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685656|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685657|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685658|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685659|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685660|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685661|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685662|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685663|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685664|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
685665|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
685666|NCT00308308|E2|Reported Event|Insulin Aspart + Insulin Glargine|Comparator
685667|NCT00308308|E1|Reported Event|TI + Insulin Glargine|TI + Insulin glargine
685668|NCT00308230|B4|Baseline|Total|Total of all reporting groups
688049|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
685673|NCT00308230|P2|Participant Flow|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
685674|NCT00308230|P1|Participant Flow|Control Group|Structurally normal heart without heart disease.
685675|NCT00308230|O3|Outcome|Heart Failure|Left ventricular failure
685676|NCT00308230|O2|Outcome|Congenital Heart Disease|TOF, DTGA, CCTGA-tetralogy of Fallot, the transposition of the great arteries, congenitally corrected transposition
685677|NCT00308230|O1|Outcome|Control Group|Structurally normal hearts
685678|NCT00308230|E3|Reported Event|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
685679|NCT00308230|E2|Reported Event|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
685680|NCT00308230|E1|Reported Event|Control Group|Structurally normal heart without heart disease
685681|NCT00308139|B3|Baseline|Total|Total of all reporting groups
685682|NCT00308139|B2|Baseline|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685683|NCT00308139|B1|Baseline|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685684|NCT00308139|P2|Participant Flow|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685685|NCT00308139|P1|Participant Flow|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685686|NCT00308139|O5|Outcome|Exenatide Once Weekly With Non-SU|Subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
685687|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364.
685688|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364
685689|NCT00308139|O2|Outcome|Exenatide Twice Daily With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) not using concomitant SU at screening. Week 0 to week 30.
685690|NCT00308139|O1|Outcome|Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 0 to week 30.
685691|NCT00308139|O5|Outcome|Exenatide Once Weekly With SU|Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
685692|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
685693|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364
685694|NCT00308139|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) using concomitant SU at screening. Week 0 to week 30.
685695|NCT00308139|O1|Outcome|Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 0 to week 30.
685696|NCT00308139|O3|Outcome|All Treatment|
685697|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685698|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685699|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685700|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685701|NCT00308139|O3|Outcome|All Treatment|
685702|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685703|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685704|NCT00308139|O3|Outcome|All Treatment|
685705|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685706|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685707|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685708|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685709|NCT00308139|O3|Outcome|All Treatment|
685710|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685711|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685712|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685713|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685714|NCT00308139|O3|Outcome|All Treatment|
685715|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once WeeklyEdit|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685716|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685717|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685718|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685719|NCT00308139|O3|Outcome|All Treatment|
685720|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685721|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685722|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685723|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685724|NCT00308139|O3|Outcome|All Treatment|
685725|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685726|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685727|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 week).
685728|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685729|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685730|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685731|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685732|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685733|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685734|NCT00308139|O3|Outcome|All Treatmeat|
685735|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685736|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685737|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685738|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685739|NCT00308139|O3|Outcome|All Treatment|
685740|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685741|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685742|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685743|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685744|NCT00308139|O3|Outcome|All Treatment|
685745|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685746|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685747|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685748|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
685749|NCT00308139|E5|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
685750|NCT00308139|E4|Reported Event|Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
685751|NCT00308139|E3|Reported Event|Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of 2 mg exenatide, once a week.
685752|NCT00308139|E2|Reported Event|Exenatide Twice Daily (WK 0-30)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
685753|NCT00308139|E1|Reported Event|Exenatide Once Weekly (WK 0-30)|Subcutaneous injection of 2 mg exenatide, once a week.
685754|NCT00308113|B5|Baseline|Total|Total of all reporting groups
685755|NCT00308113|B4|Baseline|Enhanced Standard of Care|Enhanced standard of care.
686093|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
685756|NCT00308113|B3|Baseline|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
685757|NCT00308113|B2|Baseline|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
685758|NCT00308113|B1|Baseline|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
685759|NCT00308113|P4|Participant Flow|Enhanced Standard of Care|Enhanced standard of care.
685760|NCT00308113|P3|Participant Flow|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
685761|NCT00308113|P2|Participant Flow|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
685762|NCT00308113|P1|Participant Flow|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
685763|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
685764|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
685765|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
685766|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
685767|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
685768|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
685769|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
685770|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
685771|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
685772|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
685773|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
685774|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
685775|NCT00308113|E4|Reported Event|Enhanced Standard of Care|Enhanced standard of care.
685776|NCT00308113|E3|Reported Event|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
685777|NCT00308113|E2|Reported Event|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
685778|NCT00308113|E1|Reported Event|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
685779|NCT00308087|B3|Baseline|Total|Total of all reporting groups
685780|NCT00308087|B2|Baseline|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685781|NCT00308087|B1|Baseline|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685782|NCT00308087|P2|Participant Flow|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685783|NCT00308087|P1|Participant Flow|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685784|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685785|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685786|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685787|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685788|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685789|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685790|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685791|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685792|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685793|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685827|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685794|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685795|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685796|NCT00308087|E2|Reported Event|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
685797|NCT00308087|E1|Reported Event|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
685798|NCT00308074|B1|Baseline|Aripiprazole|aripiprazole monotherapy
685799|NCT00308074|P1|Participant Flow|Aripiprazole|"aripiprazole monotherapy~Aripiprazole will be started at 2.5 or 5mg depending on clinical impression and severity of aggression and agitation. The dose will be evaluated weekly, according to clinical impression and adjusted if deemed appropriate, in not more than 5mg increments . The lowest effective dose will be used."
685800|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
685801|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
685802|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
685803|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
685804|NCT00308074|E1|Reported Event|Aripiprazole|aripiprazole monotherapy
685805|NCT00308061|B3|Baseline|Total|Total of all reporting groups
685806|NCT00308061|B2|Baseline|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
685807|NCT00308061|B1|Baseline|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
685808|NCT00308061|P2|Participant Flow|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
685809|NCT00308061|P1|Participant Flow|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
685810|NCT00308061|O1|Outcome|Geometric Mean Titer|Geometric Mean Titer (GMT)
685811|NCT00308061|O2|Outcome|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
685812|NCT00308061|O1|Outcome|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
685813|NCT00308061|E2|Reported Event|FMP1/AS02A Vaccine|"500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid."
685814|NCT00308061|E1|Reported Event|Imovax Rabies Vaccine|"1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle~Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen."
685815|NCT00307931|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685816|NCT00307931|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685817|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685818|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685819|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685820|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685821|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685822|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685823|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685824|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685825|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685826|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685828|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685829|NCT00307931|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
685830|NCT00307801|B3|Baseline|Total|Total of all reporting groups
685831|NCT00307801|B2|Baseline|Placebo|Matching placebo to be taken orally daily.
685832|NCT00307801|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685833|NCT00307801|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
685834|NCT00307801|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685835|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
685836|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685837|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
685838|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685839|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685840|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685841|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685842|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685843|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685844|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685845|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685846|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685847|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685848|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685849|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685850|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685851|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685852|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685853|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685854|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685855|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685856|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685857|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685858|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685859|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685860|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685861|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685862|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685863|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
686011|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686094|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
685864|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685865|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685866|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685867|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685868|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685869|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685870|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685871|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685872|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685873|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685874|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685875|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685876|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685877|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685878|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685879|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685880|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685881|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685882|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685883|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685884|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685885|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685886|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685887|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685888|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685889|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685890|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685891|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685892|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685893|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685894|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685895|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685896|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685897|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
686012|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686013|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
685898|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685899|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685900|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685901|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685902|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685903|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685904|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685905|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685906|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685907|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685908|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685909|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685910|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685911|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685912|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685913|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685914|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685915|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685916|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685917|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685918|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685919|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685920|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685921|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685922|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685923|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685924|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685925|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685926|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685927|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685928|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685929|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685930|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685931|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
686014|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686015|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
685932|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685933|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685934|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685935|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685936|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685937|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685938|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685939|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
685940|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685941|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
685942|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685943|NCT00307801|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
685944|NCT00307801|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
685945|NCT00307736|B1|Baseline|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib.
685946|NCT00307736|P4|Participant Flow|Phase II (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685947|NCT00307736|P3|Participant Flow|Phase 1 (150mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685948|NCT00307736|P2|Participant Flow|Phase 1 (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685949|NCT00307736|P1|Participant Flow|Phase 1 (Erlotinib 50mg)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685950|NCT00307736|O3|Outcome|Treated at MTD|"Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.~All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib."
685951|NCT00307736|O2|Outcome|Underwent Resection|"Patients who underwent R0 resection following study therapy~All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
685952|NCT00307736|O1|Outcome|Completed Study Therapy|"Patients who had pathologic complete response following completion of study therapy.~All patients receive chemo-radiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
685953|NCT00307736|O1|Outcome|Surgery, 5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Patients undergoing R0 resection following chemotherapy and radiation.~Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685954|NCT00307736|O1|Outcome|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
686016|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686017|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
688050|NCT00301262|O3|Outcome|DB Placebo Week 8|
685955|NCT00307736|O2|Outcome|Grade 4|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685956|NCT00307736|O1|Outcome|Grade 3|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685957|NCT00307736|O1|Outcome|5-FU, Bevacizumab, Erlotinib and Radiation|All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
685958|NCT00307736|E1|Reported Event|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
685959|NCT00307684|B1|Baseline|Overall Study Population|Prolonged release (PR) Osmotic Release Oral Systems (OROS) MPH 18 to 90 mg once daily during the OL phase. Subjects who had received at 52 weeks of uninterrupted treatment with PR OROS MPH and provided consent for the DB phase were randomly assigned to placebo or their previous dose of PR OROS MPH (18 to 90 mg once daily)
685960|NCT00307684|P3|Participant Flow|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685961|NCT00307684|P2|Participant Flow|Placebo|matching placebo
685962|NCT00307684|P1|Participant Flow|Active|PR OROS MPH 18 to 90 mg once daily
685963|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685964|NCT00307684|O2|Outcome|Placebo|matching placebo
685965|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
685966|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685967|NCT00307684|O2|Outcome|Placebo|matching placebo
685968|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
685969|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685970|NCT00307684|O2|Outcome|Placebo|matching placebo
685971|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
685972|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685973|NCT00307684|O2|Outcome|Placebo|matching placebo
685974|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
685975|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685976|NCT00307684|O2|Outcome|Placebo|matching placebo
685977|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
685978|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685979|NCT00307684|O2|Outcome|Placebo|matching placebo
685980|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
685981|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685982|NCT00307684|O2|Outcome|Placebo|matching placebo
685983|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
685984|NCT00307684|E3|Reported Event|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
685985|NCT00307684|E2|Reported Event|Placebo|matching placebo
685986|NCT00307684|E1|Reported Event|Active|PR OROS MPH 18 to 90 mg once daily
685987|NCT00307489|B3|Baseline|Total|Total of all reporting groups
685988|NCT00307489|B2|Baseline|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
685989|NCT00307489|B1|Baseline|Tenofovir DF|tenofovir DF 300 mg QD
685990|NCT00307489|P2|Participant Flow|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
685991|NCT00307489|P1|Participant Flow|Tenofovir DF|tenofovir DF 300 mg QD
685992|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
685993|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
685994|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
685995|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
685996|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
685997|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
685998|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
685999|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686000|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686001|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686002|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686003|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686004|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686005|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686006|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686007|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686008|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686009|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686010|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686018|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686019|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686020|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686021|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686022|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686023|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686024|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686025|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686026|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686027|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686028|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686029|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
686030|NCT00307489|E2|Reported Event|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
686031|NCT00307489|E1|Reported Event|Tenofovir DF|tenofovir DF 300 mg QD
686032|NCT00307437|B4|Baseline|Total|Total of all reporting groups
686033|NCT00307437|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
686034|NCT00307437|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
686035|NCT00307437|B1|Baseline|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
686036|NCT00307437|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
686037|NCT00307437|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
686038|NCT00307437|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
686039|NCT00307437|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
686040|NCT00307437|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
686041|NCT00307437|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
686042|NCT00307437|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
686043|NCT00307437|O6|Outcome|Group 6: Combined (12 Week Dosing)|Combined Groups 2 and 4 (dosing every 12 weeks)
686044|NCT00307437|O5|Outcome|Group 5: Combined (8 Week Dosing)|Combined Groups 1 and 3 (dosing every 8 weeks)
686045|NCT00307437|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
686046|NCT00307437|O3|Outcome|Group 3: Ustekinumab 90 mg Every 8 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16., 28, 36 and 44.
686047|NCT00307437|O2|Outcome|Group 2: Ustekinumab 45mg Every 12 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
686048|NCT00307437|O1|Outcome|Group 1: Ustekinumab 45mg Every 8 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28, 36 and 44.
686049|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
686050|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
686051|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
686052|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
686053|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
686054|NCT00307437|O1|Outcome|Group I: Placebo|Placebo partcipants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
686091|NCT00307164|P1|Participant Flow|NucleomaxX|Participants received NucleomaxX for uridine through week 48
688051|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
686055|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
686056|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
686057|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
686058|NCT00307437|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
686059|NCT00307437|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
686060|NCT00307437|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
686061|NCT00307437|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
686062|NCT00307437|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
686063|NCT00307437|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
686064|NCT00307437|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
686065|NCT00307333|B3|Baseline|Total|Total of all reporting groups
686066|NCT00307333|B2|Baseline|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
686067|NCT00307333|B1|Baseline|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
686068|NCT00307333|P2|Participant Flow|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
686069|NCT00307333|P1|Participant Flow|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
686070|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
686071|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
686072|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
686073|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
686074|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
686075|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
686076|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
686077|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
686078|NCT00307333|E2|Reported Event|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
686079|NCT00307333|E1|Reported Event|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
686080|NCT00307294|B1|Baseline|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
686081|NCT00307294|P1|Participant Flow|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
686082|NCT00307294|O1|Outcome|Thalidomide and Doxil|"Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
686083|NCT00307294|O1|Outcome|Thalidomide and Doxil|"Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
686084|NCT00307294|O1|Outcome|Thalidomide and Doxil|"Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
686085|NCT00307294|O1|Outcome|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
686086|NCT00307294|E1|Reported Event|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
686087|NCT00307164|B3|Baseline|Total|Total of all reporting groups
686088|NCT00307164|B2|Baseline|Placebo|Participants received NucleomaxX placebo through week 48
686089|NCT00307164|B1|Baseline|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686090|NCT00307164|P2|Participant Flow|Placebo|Participants received NucleomaxX placebo through week 48
686095|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686096|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686097|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686098|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686099|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686100|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686101|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686102|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686103|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686104|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686105|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686106|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686107|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686108|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686109|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686110|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686111|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686112|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686113|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686114|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686115|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686116|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686117|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686118|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686119|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686120|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686121|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686122|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
686123|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686124|NCT00307164|E2|Reported Event|Placebo|Participants received NucleomaxX placebo through week 48
686125|NCT00307164|E1|Reported Event|NucleomaxX|Participants received NucleomaxX for uridine through week 48
686126|NCT00307151|B5|Baseline|Total|Total of all reporting groups
686127|NCT00307151|B4|Baseline|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686128|NCT00307151|B3|Baseline|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686129|NCT00307151|B2|Baseline|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686130|NCT00307151|B1|Baseline|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686131|NCT00307151|P4|Participant Flow|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686132|NCT00307151|P3|Participant Flow|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686133|NCT00307151|P2|Participant Flow|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686134|NCT00307151|P1|Participant Flow|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686135|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686136|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686137|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686138|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686139|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686140|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686141|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686142|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686143|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686144|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686145|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686146|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686147|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686148|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686149|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686214|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686150|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686151|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686152|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686153|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686154|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686155|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686156|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686157|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686158|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686159|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686160|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686161|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686162|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686163|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686164|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686165|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686166|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686167|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
686168|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
686169|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686170|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686171|NCT00307151|E4|Reported Event|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
686172|NCT00307151|E3|Reported Event|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.
686173|NCT00307151|E2|Reported Event|Coh I: LPV/r|Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
686174|NCT00307151|E1|Reported Event|Coh I: NVP|Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
686175|NCT00307125|B3|Baseline|Total|Total of all reporting groups
686176|NCT00307125|B2|Baseline|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686177|NCT00307125|B1|Baseline|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686178|NCT00307125|P3|Participant Flow|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686179|NCT00307125|P2|Participant Flow|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686180|NCT00307125|P1|Participant Flow|Screening Phase|Kidney (renal) transplant recipients with no detectable anti-human leukocyte antigen (HLA) antibodies prior to transplant. Participants were screened for the development of anti-HLA antibodies once every 3 months up to 36 months post-transplantation and yearly thereafter until Month 60.
686181|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686182|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686183|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686184|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686185|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686215|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686216|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686186|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686187|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686188|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686189|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686190|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686191|NCT00307125|O2|Outcome|Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression is site-specific."
686192|NCT00307125|O1|Outcome|Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686193|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686194|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686195|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686196|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686197|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase of the study
686198|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase/stage of the study
686199|NCT00307125|E2|Reported Event|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686200|NCT00307125|E1|Reported Event|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
686201|NCT00307086|B1|Baseline|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
686202|NCT00307086|P1|Participant Flow|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
686203|NCT00307086|O1|Outcome|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
686204|NCT00307086|E1|Reported Event|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
686205|NCT00307047|B3|Baseline|Total|Total of all reporting groups
686206|NCT00307047|B2|Baseline|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686207|NCT00307047|B1|Baseline|XIENCE V®|Patients recieving the XIENCE V® stent
686208|NCT00307047|P2|Participant Flow|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686209|NCT00307047|P1|Participant Flow|XIENCE V®|Patients recieving the XIENCE V® stent
686210|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686211|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686212|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686213|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686217|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686218|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686219|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686220|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686221|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686222|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686223|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686224|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686225|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686226|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686227|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686228|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686229|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686230|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686231|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686232|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686233|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686234|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686235|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686236|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686237|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686238|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686239|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686240|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686241|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686242|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686243|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686244|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686245|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686246|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686247|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686248|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686249|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686250|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686251|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686252|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686253|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686254|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686255|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686256|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686257|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686258|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686259|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686260|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686261|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686262|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686263|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686264|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686265|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686266|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686267|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686268|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686269|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686270|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686271|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686272|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686273|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686274|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686275|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686276|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686277|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686278|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686279|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686280|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686281|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686282|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686283|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686284|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686285|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686286|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686287|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686288|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686289|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686290|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686291|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686292|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686293|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686294|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686295|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686296|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686297|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686298|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686299|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686300|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686301|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686302|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686303|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686304|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686305|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686306|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686307|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686308|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686309|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686310|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686311|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686312|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686313|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686314|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686315|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686316|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686317|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686318|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686319|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686320|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686321|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686322|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686323|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686324|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686325|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686326|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686327|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686328|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686329|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686330|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686331|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686332|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686333|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686334|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686335|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686336|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686337|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686338|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686339|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686340|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686341|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
686342|NCT00307047|E2|Reported Event|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
686343|NCT00307047|E1|Reported Event|XIENCE V®|Patients recieving the XIENCE V® stent
686344|NCT00307034|B3|Baseline|Total|Total of all reporting groups
686345|NCT00307034|B2|Baseline|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686419|NCT00306891|E3|Reported Event|Cediranib 30 - 90 mg Dose Escalation|Cediranib 30 - 90 mg Dose Escalation
686346|NCT00307034|B1|Baseline|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686347|NCT00307034|P2|Participant Flow|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686348|NCT00307034|P1|Participant Flow|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686349|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686350|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686351|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686352|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686353|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686354|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686355|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686420|NCT00306891|E2|Reported Event|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
686421|NCT00306891|E1|Reported Event|Cediranib 45 mg Part A|Part A: Cediranib 45 mg
686422|NCT00306852|B3|Baseline|Total|Total of all reporting groups
686356|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686357|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686358|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686359|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686360|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686361|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686362|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686363|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686364|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686365|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686423|NCT00306852|B2|Baseline|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686366|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686367|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686368|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686369|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686370|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686371|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686372|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686373|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686374|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686375|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686424|NCT00306852|B1|Baseline|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686376|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686377|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686378|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686379|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686380|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686381|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686382|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686383|NCT00307034|E2|Reported Event|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686384|NCT00307034|E1|Reported Event|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
686385|NCT00306917|B3|Baseline|Total|Total of all reporting groups
686386|NCT00306917|B2|Baseline|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686425|NCT00306852|P2|Participant Flow|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686958|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686959|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686387|NCT00306917|B1|Baseline|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686388|NCT00306917|P2|Participant Flow|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686389|NCT00306917|P1|Participant Flow|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686390|NCT00306917|O2|Outcome|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686391|NCT00306917|O1|Outcome|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686392|NCT00306917|E2|Reported Event|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686393|NCT00306917|E1|Reported Event|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
686394|NCT00306891|B5|Baseline|Total|Total of all reporting groups
686395|NCT00306891|B4|Baseline|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
686396|NCT00306891|B3|Baseline|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
686397|NCT00306891|B2|Baseline|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686398|NCT00306891|B1|Baseline|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686399|NCT00306891|P4|Participant Flow|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
686400|NCT00306891|P3|Participant Flow|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
686401|NCT00306891|P2|Participant Flow|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686402|NCT00306891|P1|Participant Flow|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686403|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
686404|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
686405|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
686406|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
686407|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686408|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686409|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686410|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686411|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686412|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686413|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686414|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686415|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686416|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686417|NCT00306891|O2|Outcome|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
686418|NCT00306891|O1|Outcome|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
686960|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686426|NCT00306852|P1|Participant Flow|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686427|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686428|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686429|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686430|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686431|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686432|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686433|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686434|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686435|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686436|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686437|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686438|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686439|NCT00306852|E2|Reported Event|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
686440|NCT00306852|E1|Reported Event|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
686441|NCT00306787|B3|Baseline|Total|Total of all reporting groups
686442|NCT00306787|B2|Baseline|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686443|NCT00306787|B1|Baseline|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686444|NCT00306787|P2|Participant Flow|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686445|NCT00306787|P1|Participant Flow|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686446|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686447|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686448|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686449|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686450|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686451|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686452|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686453|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686454|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686455|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686456|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686457|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686458|NCT00306787|E2|Reported Event|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
686459|NCT00306787|E1|Reported Event|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
686460|NCT00306670|B3|Baseline|Total|Total of all reporting groups
686461|NCT00306670|B2|Baseline|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
686462|NCT00306670|B1|Baseline|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
686463|NCT00306670|P2|Participant Flow|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
686464|NCT00306670|P1|Participant Flow|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
686465|NCT00306670|O2|Outcome|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
686466|NCT00306670|O1|Outcome|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
686467|NCT00306670|E2|Reported Event|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
686468|NCT00306670|E1|Reported Event|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
686469|NCT00306592|B1|Baseline|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
686470|NCT00306592|P2|Participant Flow|Natalizumab Study 101-MS-321 (NCT00297232)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).
686471|NCT00306592|P1|Participant Flow|Natalizumab Study 101-MS-322 (NCT00306592)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
686472|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
686567|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686473|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
686474|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
686475|NCT00306592|E1|Reported Event|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
686476|NCT00306527|B5|Baseline|Total|Total of all reporting groups
686477|NCT00306527|B4|Baseline|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
686478|NCT00306527|B3|Baseline|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
686479|NCT00306527|B2|Baseline|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
686480|NCT00306527|B1|Baseline|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
686481|NCT00306527|P4|Participant Flow|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
686482|NCT00306527|P3|Participant Flow|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
686483|NCT00306527|P2|Participant Flow|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
686484|NCT00306527|P1|Participant Flow|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
686485|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686486|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686487|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686488|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686489|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686490|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686491|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686492|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686493|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686494|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686495|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686496|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686497|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686498|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686499|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686500|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686501|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686502|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686503|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686504|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686505|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686506|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686507|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686508|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686509|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686510|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686511|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686512|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686513|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686514|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686515|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686516|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686517|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686518|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686519|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686520|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686521|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686522|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686523|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686524|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686525|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686526|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686527|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
686528|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686568|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686529|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686530|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686531|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
686532|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
686533|NCT00306527|E4|Reported Event|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
686534|NCT00306527|E3|Reported Event|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
686535|NCT00306527|E2|Reported Event|Adults (cTIV/TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
686536|NCT00306527|E1|Reported Event|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
686537|NCT00306488|B1|Baseline|Participant Information|
686538|NCT00306488|P2|Participant Flow|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
686539|NCT00306488|P1|Participant Flow|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
686540|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
686541|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
686542|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
686543|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
686544|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
686545|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
686546|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
686547|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
686548|NCT00306488|E1|Reported Event|Participant Adverse Event Information|
686549|NCT00306384|B4|Baseline|Total|Total of all reporting groups
686550|NCT00306384|B3|Baseline|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686551|NCT00306384|B2|Baseline|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686552|NCT00306384|B1|Baseline|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686553|NCT00306384|P3|Participant Flow|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686554|NCT00306384|P2|Participant Flow|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686555|NCT00306384|P1|Participant Flow|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686556|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686557|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686558|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686559|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686560|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686561|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686562|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686563|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686564|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686565|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686566|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686569|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686570|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686571|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686572|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686573|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686574|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686575|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686576|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686577|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686578|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686579|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686580|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686581|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686582|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686583|NCT00306384|E3|Reported Event|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
686584|NCT00306384|E2|Reported Event|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
686585|NCT00306384|E1|Reported Event|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
686586|NCT00306293|B1|Baseline|Overall Study|Participants received VALTREX 1 g (2 x500 mg caplets) and matching placebo 2 caplets, orally, OD, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686587|NCT00306293|P2|Participant Flow|Placebo First Then VALTREX 1 g|Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
686588|NCT00306293|P1|Participant Flow|VALTREX 1 g First Then Placebo|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days.
686589|NCT00306293|O2|Outcome|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686590|NCT00306293|O1|Outcome|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686591|NCT00306293|O2|Outcome|Placebo First Then VALTREX 1 g|Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
686592|NCT00306293|O1|Outcome|VALTREX 1 g First Then Placebo|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days.
686593|NCT00306293|O2|Outcome|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686594|NCT00306293|O1|Outcome|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686595|NCT00306293|O2|Outcome|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686596|NCT00306293|O1|Outcome|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686597|NCT00306293|O2|Outcome|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686598|NCT00306293|O1|Outcome|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686599|NCT00306293|O2|Outcome|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
688052|NCT00301262|O1|Outcome|DB Viagra Week 8|
686600|NCT00306293|O1|Outcome|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686601|NCT00306293|O2|Outcome|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686602|NCT00306293|O1|Outcome|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686603|NCT00306293|E2|Reported Event|Placebo|Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686604|NCT00306293|E1|Reported Event|VALTREX 1 g, OD|Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
686605|NCT00306202|B4|Baseline|Total|Total of all reporting groups
686606|NCT00306202|B3|Baseline|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686607|NCT00306202|B2|Baseline|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686608|NCT00306202|B1|Baseline|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686609|NCT00306202|P3|Participant Flow|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686610|NCT00306202|P2|Participant Flow|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686611|NCT00306202|P1|Participant Flow|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686612|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686613|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686614|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686615|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686616|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686617|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686618|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686619|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686643|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
688100|NCT00301262|O1|Outcome|DB Viagra Week 8|
686620|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686621|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686622|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686623|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686624|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686625|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686626|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686627|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686628|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686629|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686630|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686631|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686632|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686633|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686634|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686635|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686636|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686637|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686638|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686639|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686640|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686641|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686642|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686787|NCT00306163|P1|Participant Flow|Ciclesonide|160 µg, once daily
686644|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686645|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686646|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686647|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686648|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686649|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686650|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686651|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686652|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686653|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686654|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686655|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686656|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686657|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686658|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686659|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
686660|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
686661|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686662|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686663|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
686664|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
686665|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
686788|NCT00306163|O2|Outcome|Fluticasone|100 µg, twice daily
686789|NCT00306163|O1|Outcome|Ciclesonide|160 µg, once daily
686790|NCT00306163|E2|Reported Event|Fluticasone|100 µg, twice daily
686791|NCT00306163|E1|Reported Event|Ciclesonide|160 µg, once daily
686666|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
686667|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
686668|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686669|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686670|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686671|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2.~QD, as long as clinical benefit was maintained."
686672|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686673|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686674|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686675|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686676|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686677|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686678|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686679|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686680|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686681|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686682|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686683|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
686684|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
686685|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
686686|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
686687|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
686688|NCT00306202|O2|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
686689|NCT00306202|O1|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686690|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686691|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686692|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686693|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686694|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686695|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686696|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
686697|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
686698|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
686699|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686700|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686701|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686702|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686703|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686961|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686704|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686705|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 1 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686706|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686707|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686708|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686709|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686710|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686711|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686712|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686713|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686714|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686715|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686716|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686717|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686718|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686719|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686720|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
686721|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
686722|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
686723|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686724|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686962|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686963|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686725|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686726|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
686727|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686728|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
686729|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
686730|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
686731|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686732|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686733|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686734|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
686735|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686736|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
686737|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
686738|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
686739|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686740|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686741|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686742|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686743|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686744|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
686745|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
686746|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
686747|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686748|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686792|NCT00305942|B1|Baseline|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
686749|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686750|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686751|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686752|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
686753|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
686754|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
686755|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
686756|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686757|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686758|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
686759|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
686760|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2, escalated/dose level 3 of 100 mg/m^2, escalated/dose level 3 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686761|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686762|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686763|NCT00306202|E3|Reported Event|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
686764|NCT00306202|E2|Reported Event|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
686765|NCT00306202|E1|Reported Event|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
686766|NCT00306189|B5|Baseline|Total|Total of all reporting groups
686767|NCT00306189|B4|Baseline|Placebo|
686768|NCT00306189|B3|Baseline|Denosumab 100 mg Q6M|
686769|NCT00306189|B2|Baseline|Denosumab 60 mg Q6M|
686770|NCT00306189|B1|Baseline|Denosumab 14 mg Q6M|
686771|NCT00306189|P4|Participant Flow|Placebo|
686772|NCT00306189|P3|Participant Flow|Denosumab 100 mg Q6M|
686773|NCT00306189|P2|Participant Flow|Denosumab 60 mg Q6M|
686774|NCT00306189|P1|Participant Flow|Denosumab 14 mg Q6M|
686775|NCT00306189|O4|Outcome|Denosumab 100 mg Q6M|
686776|NCT00306189|O3|Outcome|Denosumab 60 mg Q6M|
686777|NCT00306189|O2|Outcome|Denosumab 14 mg Q6M|
686778|NCT00306189|O1|Outcome|Placebo|
686779|NCT00306189|E4|Reported Event|Denosumab 100 mg Q6M|
686780|NCT00306189|E3|Reported Event|Denosumab 60 mg Q6M|
686781|NCT00306189|E2|Reported Event|Denosumab 14 mg Q6M|
686782|NCT00306189|E1|Reported Event|Placebo|
686783|NCT00306163|B3|Baseline|Total|Total of all reporting groups
686784|NCT00306163|B2|Baseline|Fluticasone|100 µg, twice daily
686785|NCT00306163|B1|Baseline|Ciclesonide|160 µg, once daily
686786|NCT00306163|P2|Participant Flow|Fluticasone|100 µg, twice daily
686793|NCT00305942|P1|Participant Flow|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
686794|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
686795|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
686796|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
686797|NCT00305942|E1|Reported Event|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
686798|NCT00305877|B3|Baseline|Total|Total of all reporting groups
686799|NCT00305877|B2|Baseline|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
686800|NCT00305877|B1|Baseline|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
686801|NCT00305877|P2|Participant Flow|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
686802|NCT00305877|P1|Participant Flow|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
686803|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
686804|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
686805|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
686806|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
686807|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
686808|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
686809|NCT00305877|E2|Reported Event|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
686810|NCT00305877|E1|Reported Event|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
686811|NCT00305864|B5|Baseline|Total|Total of all reporting groups
686812|NCT00305864|B4|Baseline|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686842|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686964|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686965|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686813|NCT00305864|B3|Baseline|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686814|NCT00305864|B2|Baseline|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686815|NCT00305864|B1|Baseline|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686816|NCT00305864|P4|Participant Flow|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686817|NCT00305864|P3|Participant Flow|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686818|NCT00305864|P2|Participant Flow|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686819|NCT00305864|P1|Participant Flow|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686820|NCT00305864|O1|Outcome|All MGd 5mg/kg Patients (Phase I and II Arms Combined)|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686821|NCT00305864|O1|Outcome|All MGd 5mg/kg Patients (Phase I and II Arms Combined)|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686822|NCT00305864|O3|Outcome|Phase I: 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686843|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686966|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686823|NCT00305864|O2|Outcome|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686824|NCT00305864|O1|Outcome|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686825|NCT00305864|E4|Reported Event|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686826|NCT00305864|E3|Reported Event|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686827|NCT00305864|E2|Reported Event|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686828|NCT00305864|E1|Reported Event|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
686829|NCT00305773|B3|Baseline|Total|Total of all reporting groups
686830|NCT00305773|B2|Baseline|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686831|NCT00305773|B1|Baseline|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686832|NCT00305773|P2|Participant Flow|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686833|NCT00305773|P1|Participant Flow|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686834|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686835|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686836|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686837|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686838|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686839|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686840|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686841|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686953|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686844|NCT00305773|E2|Reported Event|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686845|NCT00305773|E1|Reported Event|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
686846|NCT00305760|B1|Baseline|Group 1|
686847|NCT00305760|P1|Participant Flow|Group 1|
686848|NCT00305760|O1|Outcome|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|
686849|NCT00305760|E1|Reported Event|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|"Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.~Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.~Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles."
686850|NCT00305643|B3|Baseline|Total|Total of all reporting groups
686851|NCT00305643|B2|Baseline|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686852|NCT00305643|B1|Baseline|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686853|NCT00305643|P2|Participant Flow|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686854|NCT00305643|P1|Participant Flow|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686855|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686856|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686857|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686858|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686859|NCT00305643|E2|Reported Event|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686860|NCT00305643|E1|Reported Event|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
686861|NCT00305604|B3|Baseline|Total|Total of all reporting groups
686862|NCT00305604|B2|Baseline|Placebo|Sitagliptin-matching placebo tablets.
686863|NCT00305604|B1|Baseline|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
686864|NCT00305604|P2|Participant Flow|Placebo|Sitagliptin-matching placebo tablets.
686865|NCT00305604|P1|Participant Flow|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
686866|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
686867|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
686868|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
686869|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
686870|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
686871|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
686872|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
686873|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
686874|NCT00305604|E2|Reported Event|Placebo|Sitagliptin-matching placebo tablets.
686875|NCT00305604|E1|Reported Event|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
686876|NCT00305578|B3|Baseline|Total|Total of all reporting groups
686877|NCT00305578|B2|Baseline|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
686878|NCT00305578|B1|Baseline|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
686879|NCT00305578|P2|Participant Flow|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
686880|NCT00305578|P1|Participant Flow|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
686954|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686955|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686956|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686881|NCT00305578|O2|Outcome|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
686882|NCT00305578|O1|Outcome|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
686883|NCT00305578|E2|Reported Event|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
686884|NCT00305578|E1|Reported Event|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
686885|NCT00305565|B4|Baseline|Total|Total of all reporting groups
686886|NCT00305565|B3|Baseline|High Dose|Received output current 1.0-1.5 mA
686887|NCT00305565|B2|Baseline|Medium Dose|Received output current 0.5-1.0 mA
686888|NCT00305565|B1|Baseline|Low Dose|Received output current 0.25 mA
686889|NCT00305565|P3|Participant Flow|High Dose|Received output current 1.0-1.5 mA
686890|NCT00305565|P2|Participant Flow|Medium Dose|Received output current 0.5-1.0 mA
686891|NCT00305565|P1|Participant Flow|Low Dose|Received output current 0.25 milliamps (mA)
686892|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686893|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686894|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686895|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686896|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686897|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686898|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686899|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686900|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686901|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686902|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686903|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686904|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686905|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686906|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686907|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686908|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686909|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686910|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686911|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686912|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686913|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686914|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686915|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686916|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686917|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686918|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686919|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686920|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686921|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686922|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686923|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686924|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686925|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686926|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686927|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686928|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686929|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686930|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686931|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686932|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686933|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686934|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686935|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686936|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686937|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
686938|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
686939|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686940|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686941|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686942|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686943|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686944|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686945|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686946|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686947|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686948|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686949|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686950|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686951|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686952|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686967|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686968|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686969|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686970|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686971|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686972|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686973|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686974|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686975|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686976|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686977|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686978|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686979|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686980|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686981|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686982|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686983|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686984|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686985|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686986|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686987|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686988|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686989|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686990|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686991|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686992|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686993|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686994|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686995|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686996|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
686997|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
686998|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
686999|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
687000|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
687001|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
687002|NCT00305565|E3|Reported Event|High Dose|Received output current 1.0-1.5 mA
687003|NCT00305565|E2|Reported Event|Medium Dose|Received output current 0.5-1.0 mA
687004|NCT00305565|E1|Reported Event|Low Dose|Received output current 0.25 mA
687005|NCT00305448|B4|Baseline|Total|Total of all reporting groups
687006|NCT00305448|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
687007|NCT00305448|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
687008|NCT00305448|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
687009|NCT00305448|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
687010|NCT00305448|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
687011|NCT00305448|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
687012|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
687013|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
687014|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
687015|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
687016|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
687017|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
687018|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
687019|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
687020|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
687021|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
687022|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
687023|NCT00305448|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
687024|NCT00305448|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
687025|NCT00305448|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
687026|NCT00305344|B1|Baseline|Cord Blood Recipient|Umbilical Cord Recipient
687027|NCT00305344|P1|Participant Flow|Cord Blood Recipient|Umbilical Cord Recipient
687028|NCT00305344|O1|Outcome|Recipients Receiving Cord Blood|Children with type 1 diabetes who underwent an autologous cord blood infusion
687029|NCT00305344|E1|Reported Event|Cord Blood Recipients|Children with type 1 diabetes who underwent an autologous cord blood infusion
687030|NCT00305253|B3|Baseline|Total|Total of all reporting groups
687031|NCT00305253|B2|Baseline|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
687032|NCT00305253|B1|Baseline|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
687033|NCT00305253|P2|Participant Flow|Post-Intervention|Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.
687034|NCT00305253|P1|Participant Flow|Pre-Intervention|Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.
687035|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
687036|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
688101|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
687037|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
687038|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
687039|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
687040|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
687041|NCT00305253|E2|Reported Event|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
687042|NCT00305253|E1|Reported Event|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
687043|NCT00305227|B3|Baseline|Total|Total of all reporting groups
687044|NCT00305227|B2|Baseline|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687045|NCT00305227|B1|Baseline|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687046|NCT00305227|P2|Participant Flow|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687047|NCT00305227|P1|Participant Flow|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687048|NCT00305227|O2|Outcome|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687049|NCT00305227|O1|Outcome|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687050|NCT00305227|E2|Reported Event|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687051|NCT00305227|E1|Reported Event|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
687052|NCT00305162|B3|Baseline|Total|Total of all reporting groups
687053|NCT00305162|B2|Baseline|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687054|NCT00305162|B1|Baseline|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
687055|NCT00305162|P2|Participant Flow|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion followed by placebo capsules post infusion
687056|NCT00305162|P1|Participant Flow|Cangrelor Arm|cangrelor arm: placebo capsules at PCI start + cangrelor bolus(30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
687057|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687058|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687059|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687060|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687061|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687062|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687063|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687064|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687065|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687066|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687067|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687068|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687069|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687344|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687070|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687071|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687072|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687073|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687074|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687075|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687076|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687077|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687078|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687079|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687080|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687081|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687082|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687083|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687084|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687085|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687086|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687087|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687088|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687089|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687090|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
687091|NCT00305162|E2|Reported Event|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
687092|NCT00305162|E1|Reported Event|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
687093|NCT00304954|B5|Baseline|Total|Total of all reporting groups
687094|NCT00304954|B4|Baseline|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
687095|NCT00304954|B3|Baseline|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
687096|NCT00304954|B2|Baseline|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
687097|NCT00304954|B1|Baseline|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
687345|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687098|NCT00304954|P4|Participant Flow|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
687099|NCT00304954|P3|Participant Flow|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
687100|NCT00304954|P2|Participant Flow|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
687101|NCT00304954|P1|Participant Flow|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
687102|NCT00304954|O4|Outcome|Sixth-Month OCT - Fellow Eye|
687103|NCT00304954|O3|Outcome|Baseline OCT - Fellow Eye|
687104|NCT00304954|O2|Outcome|Sixth-Month OCT - Study Eye|
687105|NCT00304954|O1|Outcome|Baseline OCT - Study Eye|
687106|NCT00304954|O4|Outcome|Sixth-Month Vision - Fellow Eye|
687107|NCT00304954|O3|Outcome|Baseline Vision - Fellow Eye|
687108|NCT00304954|O2|Outcome|Sixth-Month Vision - Study Eye|
687109|NCT00304954|O1|Outcome|Baseline Vision - Study Eye|
687110|NCT00304954|O4|Outcome|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
687111|NCT00304954|O3|Outcome|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
687112|NCT00304954|O2|Outcome|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
687113|NCT00304954|O1|Outcome|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
687114|NCT00304954|E4|Reported Event|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
687115|NCT00304954|E3|Reported Event|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
687116|NCT00304954|E2|Reported Event|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
687117|NCT00304954|E1|Reported Event|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
687118|NCT00304915|B3|Baseline|Total|Total of all reporting groups
687119|NCT00304915|B2|Baseline|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
687120|NCT00304915|B1|Baseline|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
687121|NCT00304915|P2|Participant Flow|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
687122|NCT00304915|P1|Participant Flow|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
687123|NCT00304915|O2|Outcome|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
687124|NCT00304915|O1|Outcome|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
687125|NCT00304915|E2|Reported Event|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
687160|NCT00304265|P1|Participant Flow|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
687346|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687126|NCT00304915|E1|Reported Event|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
687127|NCT00304746|B3|Baseline|Total|Total of all reporting groups
687128|NCT00304746|B2|Baseline|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
687129|NCT00304746|B1|Baseline|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
687130|NCT00304746|P2|Participant Flow|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
687131|NCT00304746|P1|Participant Flow|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
687132|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
687133|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
687134|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
687135|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
687136|NCT00304746|E2|Reported Event|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
687137|NCT00304746|E1|Reported Event|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
687138|NCT00304707|B3|Baseline|Total|Total of all reporting groups
687139|NCT00304707|B2|Baseline|Placebo|"placebo~placebo: placebo"
687140|NCT00304707|B1|Baseline|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
687141|NCT00304707|P2|Participant Flow|Placebo|"placebo~placebo: placebo"
687142|NCT00304707|P1|Participant Flow|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
687143|NCT00304707|O2|Outcome|Placebo|"placebo~placebo: placebo"
687144|NCT00304707|O1|Outcome|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
687145|NCT00304707|E2|Reported Event|Placebo|"placebo~placebo: placebo"
687146|NCT00304707|E1|Reported Event|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
687147|NCT00304356|B1|Baseline|Nitazoxanide|Patients with C. difficle who exhibit diarrhea and received nitazoxanide.
687148|NCT00304356|P1|Participant Flow|Nitazoxanide|
687149|NCT00304356|O1|Outcome|Nitazoxanide|time diarrhea from C. difficile stopped.
687150|NCT00304356|E1|Reported Event|Nitazoxanide|
687151|NCT00304278|B1|Baseline|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
687152|NCT00304278|P1|Participant Flow|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
687153|NCT00304278|O1|Outcome|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
687154|NCT00304278|O1|Outcome|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
687155|NCT00304278|E1|Reported Event|RADPLAT and Tarceva|"All patients will receive RADPLAT and Tarceva:~Drug: Erlotinib (Tarceva)~150 mg daily X 7 weeks~Other Names:~Tarceva~Drug: Intra-arterial Cisplatin (PLAT)~1 dose (150 mg/sq) per week X 4 weeks~Other Names:~Cisplatin~Radiation: Radiation Therapy (RAD)~5 days per week X 7 weeks~Erlotinib (Tarceva): 150 mg daily X 7 weeks~Intra-arterial Cisplatin (PLAT): 1 dose (150 mg/sq) per week X 4 weeks~Radiation Therapy (RAD): 5 days per week X 7 weeks"
687156|NCT00304265|B3|Baseline|Total|Total of all reporting groups
687157|NCT00304265|B2|Baseline|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
687158|NCT00304265|B1|Baseline|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
687159|NCT00304265|P2|Participant Flow|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
688102|NCT00301262|O3|Outcome|DB Placebo Week 8|
687161|NCT00304265|O2|Outcome|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
687162|NCT00304265|O1|Outcome|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
687163|NCT00304265|E2|Reported Event|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
687164|NCT00304265|E1|Reported Event|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
687165|NCT00304187|B3|Baseline|Total|Total of all reporting groups
687166|NCT00304187|B2|Baseline|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
687167|NCT00304187|B1|Baseline|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
687168|NCT00304187|P2|Participant Flow|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
687169|NCT00304187|P1|Participant Flow|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
687170|NCT00304187|O2|Outcome|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
687171|NCT00304187|O1|Outcome|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
687172|NCT00304187|E2|Reported Event|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
687173|NCT00304187|E1|Reported Event|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
687174|NCT00304161|B3|Baseline|Total|Total of all reporting groups
687175|NCT00304161|B2|Baseline|Placebo|Participants will receive placebo treatment
687176|NCT00304161|B1|Baseline|Atomoxetine|Participants will receive atomoxetine treatment
687177|NCT00304161|P2|Participant Flow|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
687178|NCT00304161|P1|Participant Flow|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
687179|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
687180|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
687181|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
687182|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
687183|NCT00304161|E2|Reported Event|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
687184|NCT00304161|E1|Reported Event|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
687185|NCT00304096|B3|Baseline|Total|Total of all reporting groups
687186|NCT00304096|B2|Baseline|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
687187|NCT00304096|B1|Baseline|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
687188|NCT00304096|P2|Participant Flow|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
687189|NCT00304096|P1|Participant Flow|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
687190|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
687191|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
687192|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
687193|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
687194|NCT00304096|E2|Reported Event|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
687195|NCT00304096|E1|Reported Event|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
687196|NCT00304083|B3|Baseline|Total|Total of all reporting groups
687197|NCT00304083|B2|Baseline|Sporadic Malignant Peripheral Nerve Sheath Tumors (MPNST)|Patients received 2 cycles of doxorubicin and ifosfamide followed by 2 cycles of ifosfamide and etoposide.
687198|NCT00304083|B1|Baseline|Neurofibromatosis Type 1- (NF1-) Associated|Patients received 2 cycles of doxorubicin and ifosfamide followed by 2 cycles of ifosfamide and etoposide.
687263|NCT00303901|B1|Baseline|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
687347|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687199|NCT00304083|P2|Participant Flow|Sporadic MPNST|"2 cycles of ifosfamide + doxorubicin (‘IA’) followed by 2 cycles of ifosfamide + etoposide (‘IE’) prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of ‘IA’ followed by 2 cycles of ‘IE’ beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of ‘IE’ during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of ‘IA’ after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
687200|NCT00304083|P1|Participant Flow|NF1 MPNST|"2 cycles of ifosfamide + doxorubicin (‘IA’) followed by 2 cycles of ifosfamide + etoposide (‘IE’) prior to local control measures (surgery and/or radiation therapy).~Local control with surgery and/or radiation will commence after recovery from toxicities. Patients, who undergo surgery only, will receive 2 more cycles of ‘IA’ followed by 2 cycles of ‘IE’ beginning after recovery from surgery. Patients, who receive radiation therapy in addition to surgery, will receive 2 cycles of ‘IE’ during radiation treatment, as doxorubicin cannot be concurrently administered with radiation therapy, and 2 cycles of ‘IA’ after completion of radiation treatment.~1 cycle = 21 days Doxo = Doxorubicin 37.5 mg/m2/dose IV over 15 minutes on days 1, 2 Ifos = Ifosfamide 1,800 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5 Etop = Etoposide 100 mg/m2/dose IV over 60 minutes on days 1, 2, 3, 4, 5"
687201|NCT00304083|O2|Outcome|Sporadic MPNST|Sporadic MPNST
687202|NCT00304083|O1|Outcome|Neurofibromatosis Type-1 Associated|NF1 associated MPNST
687203|NCT00304083|E1|Reported Event|NF-1 and Sporadic MPNST|NF-1 Associated and Sporadic MPNST combined
687204|NCT00304070|B4|Baseline|Total|Total of all reporting groups
687205|NCT00304070|B3|Baseline|Stratum 3|Stage III OR IV Disease (chemotherapy)
687206|NCT00304070|B2|Baseline|Stratum 2|Stage II Disease (surgery, observation)
687207|NCT00304070|B1|Baseline|Stratum 1|Stage I Disease (surgery, observation)
687208|NCT00304070|P3|Participant Flow|Stratum 3|Stage III OR IV Disease (chemotherapy)
687209|NCT00304070|P2|Participant Flow|Stratum 2|Stage II Disease (surgery, observation)
687210|NCT00304070|P1|Participant Flow|Stratum 1|Stage I Disease (surgery, observation)
687211|NCT00304070|O1|Outcome|All Patients|The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.
687212|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients who had surgery at study enrollment and have A43 del33bp mutation of (beta)-catenins.
687213|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients from whom blood was obtained as well as the frequency of the relevant mutation in each group.
687214|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the frequency reflects the total number of patients who had lymph node involvement by imaging at study enrollment.
687215|NCT00304070|O1|Outcome|All Patients|The complication rate is estimated as the proportion of evaluable patients that have a complication as it relates to surgery.
687216|NCT00304070|O1|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
687217|NCT00304070|O3|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
687218|NCT00304070|O2|Outcome|Stratum 2|Stage II Disease (surgery, observation)
687219|NCT00304070|O1|Outcome|Stratum 1|Stage I Disease (surgery, observation)
687220|NCT00304070|E1|Reported Event|Stratum 3|Stage III OR IV Disease (chemotherapy)
687221|NCT00304031|B4|Baseline|Total|Total of all reporting groups
687222|NCT00304031|B3|Baseline|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
687223|NCT00304031|B2|Baseline|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
687224|NCT00304031|B1|Baseline|No Adjuvant TMZ (Not Randomized )|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
687225|NCT00304031|P3|Participant Flow|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
687226|NCT00304031|P2|Participant Flow|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
687227|NCT00304031|P1|Participant Flow|No Adjuvant TMZ (Not Randomized)|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
687228|NCT00304031|O2|Outcome|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
687229|NCT00304031|O1|Outcome|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
687230|NCT00304031|E3|Reported Event|Dose-dense Adjuvant TMZ|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions~75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle: Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
687342|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
688103|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
687231|NCT00304031|E2|Reported Event|Conventional Adjuvant TMZ|"Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions~100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle: Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
687232|NCT00304031|E1|Reported Event|No Adjuvant TMZ (Not Randomized)|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions"
687233|NCT00303979|B4|Baseline|Total|Total of all reporting groups
687234|NCT00303979|B3|Baseline|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
687235|NCT00303979|B2|Baseline|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
687236|NCT00303979|B1|Baseline|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
687237|NCT00303979|P3|Participant Flow|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
687238|NCT00303979|P2|Participant Flow|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
687239|NCT00303979|P1|Participant Flow|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
687240|NCT00303979|O1|Outcome|Cohort C (18 Month)|The number of sites in Cohort C.
687241|NCT00303979|O1|Outcome|Cohort B (6 Month)|Number of sites in Cohort B (6 Month).
687242|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
687243|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
687244|NCT00303979|O1|Outcome|Cohort A (Longitudinal)|"For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. There will be two analysis sets from this cohort:~All Patients: All patients with baseline data Completers: Patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months."
687245|NCT00303979|E3|Reported Event|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
687246|NCT00303979|E2|Reported Event|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
687247|NCT00303979|E1|Reported Event|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
687248|NCT00303966|B1|Baseline|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687249|NCT00303966|P1|Participant Flow|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687250|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687251|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687252|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687253|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687254|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687255|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687256|NCT00303966|E1|Reported Event|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
687257|NCT00303953|B1|Baseline|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
687258|NCT00303953|P1|Participant Flow|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
687259|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
687260|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
687261|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
687262|NCT00303953|E1|Reported Event|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
687493|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687264|NCT00303901|P1|Participant Flow|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
687265|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
687266|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
687267|NCT00303901|E1|Reported Event|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
687268|NCT00303862|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
687269|NCT00303862|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
687270|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
687271|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
687272|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
687273|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
687274|NCT00303862|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
687275|NCT00303823|B3|Baseline|Total|Total of all reporting groups
687276|NCT00303823|B2|Baseline|Placebo|
687277|NCT00303823|B1|Baseline|Polyphenon E|
687278|NCT00303823|P2|Participant Flow|Placebo|Patients receive oral placebo once daily for 16 weeks
687279|NCT00303823|P1|Participant Flow|Polyphenon E (Defined Green Tea Catechin Extract)|Patients receive oral Polyphenon E daily for 16 weeks
687280|NCT00303823|O2|Outcome|Placebo|
687281|NCT00303823|O1|Outcome|Polyphenon E|
687282|NCT00303823|O2|Outcome|Placebo|
687283|NCT00303823|O1|Outcome|Polyphenon E|
687284|NCT00303823|O2|Outcome|Placebo|
687285|NCT00303823|O1|Outcome|Polyphenon E|
687286|NCT00303823|O2|Outcome|Placebo|
687287|NCT00303823|O1|Outcome|Polyphenon E|
687288|NCT00303823|E2|Reported Event|Placebo|
687289|NCT00303823|E1|Reported Event|Polyphenon E|
687290|NCT00303667|B3|Baseline|Total|Total of all reporting groups
687291|NCT00303667|B2|Baseline|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687292|NCT00303667|B1|Baseline|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687293|NCT00303667|P2|Participant Flow|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687294|NCT00303667|P1|Participant Flow|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687295|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687296|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687297|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687343|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687298|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687299|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687300|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687301|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687302|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687303|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687304|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687305|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687306|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687307|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687308|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687309|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687310|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687311|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687312|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687313|NCT00303667|E2|Reported Event|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687314|NCT00303667|E1|Reported Event|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
687315|NCT00303628|B3|Baseline|Total|Total of all reporting groups
687316|NCT00303628|B2|Baseline|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687317|NCT00303628|B1|Baseline|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687318|NCT00303628|P2|Participant Flow|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687319|NCT00303628|P1|Participant Flow|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687320|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687321|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687322|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687323|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687324|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687325|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687326|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687327|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687328|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687329|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687330|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
687331|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
687332|NCT00303628|E2|Reported Event|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I
687333|NCT00303628|E1|Reported Event|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence of disease progression or unacceptable toxicity.
687334|NCT00303602|B3|Baseline|Total|Total of all reporting groups
687335|NCT00303602|B2|Baseline|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687336|NCT00303602|B1|Baseline|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687337|NCT00303602|P2|Participant Flow|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687338|NCT00303602|P1|Participant Flow|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687339|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687340|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687341|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687494|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687639|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
687348|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687349|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687350|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687351|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687352|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687353|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687354|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687355|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687356|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687357|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687358|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687359|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687360|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687361|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687362|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687363|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687364|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687365|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687366|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687367|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687368|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687369|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687370|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687371|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687372|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687373|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687374|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687375|NCT00303602|E2|Reported Event|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
687376|NCT00303602|E1|Reported Event|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
687377|NCT00303511|B1|Baseline|ACHD With Pacemaker|
687378|NCT00303511|P1|Participant Flow|ACHD With Pacemaker|
687379|NCT00303511|O1|Outcome|Cohort|
687380|NCT00303511|E1|Reported Event|ACHD With Pacemaker|
687381|NCT00303485|B3|Baseline|Total|Total of all reporting groups
687382|NCT00303485|B2|Baseline|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687383|NCT00303485|B1|Baseline|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687384|NCT00303485|P2|Participant Flow|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
688104|NCT00301262|O1|Outcome|DB Viagra Week 8|
687385|NCT00303485|P1|Participant Flow|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687386|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687387|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687388|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687389|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687390|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687391|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687392|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687393|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687394|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687395|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687396|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687397|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687398|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687399|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687400|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687401|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687402|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687403|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687404|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687405|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687406|NCT00303485|E2|Reported Event|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
687407|NCT00303485|E1|Reported Event|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
687408|NCT00303472|B8|Baseline|Total|Total of all reporting groups
687409|NCT00303472|B7|Baseline|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687410|NCT00303472|B6|Baseline|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687411|NCT00303472|B5|Baseline|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687412|NCT00303472|B4|Baseline|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687413|NCT00303472|B3|Baseline|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687414|NCT00303472|B2|Baseline|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687415|NCT00303472|B1|Baseline|Part A: 300 µg Romiplostim|Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687416|NCT00303472|P7|Participant Flow|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687417|NCT00303472|P6|Participant Flow|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687418|NCT00303472|P5|Participant Flow|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687419|NCT00303472|P4|Participant Flow|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687420|NCT00303472|P3|Participant Flow|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687421|NCT00303472|P2|Participant Flow|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687422|NCT00303472|P1|Participant Flow|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687423|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687424|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687425|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687426|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687427|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687428|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687429|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687430|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687431|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687432|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687433|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687434|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687435|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687436|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687437|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687438|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687439|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687440|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687441|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687442|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687443|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687444|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687445|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687446|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687447|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687448|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687449|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687450|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687451|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687452|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687453|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687454|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687455|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687456|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687457|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687458|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687459|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687460|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687495|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687461|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687462|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687463|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687464|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687465|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687466|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687467|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687468|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687469|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687470|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687471|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687472|NCT00303472|E7|Reported Event|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
687473|NCT00303472|E6|Reported Event|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
687474|NCT00303472|E5|Reported Event|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687475|NCT00303472|E4|Reported Event|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687476|NCT00303472|E3|Reported Event|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687477|NCT00303472|E2|Reported Event|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687478|NCT00303472|E1|Reported Event|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
687479|NCT00303459|B3|Baseline|Total|Total of all reporting groups
687480|NCT00303459|B2|Baseline|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687481|NCT00303459|B1|Baseline|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687482|NCT00303459|P2|Participant Flow|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687483|NCT00303459|P1|Participant Flow|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d."
687484|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687485|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687486|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687487|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687488|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687489|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687490|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687491|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687492|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687496|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687497|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687498|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687499|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687500|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687501|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687502|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687503|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687504|NCT00303459|E2|Reported Event|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
687505|NCT00303459|E1|Reported Event|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
687506|NCT00303446|B3|Baseline|Total|Total of all reporting groups
687507|NCT00303446|B2|Baseline|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687508|NCT00303446|B1|Baseline|Placebo|Matched placebo, one tablet daily
687509|NCT00303446|P2|Participant Flow|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687510|NCT00303446|P1|Participant Flow|Placebo|Matched placebo, one tablet daily
687511|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687512|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687513|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687514|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687515|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687516|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687517|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687518|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687519|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687520|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687521|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687522|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687523|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687524|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687525|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687526|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687527|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687528|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687529|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687530|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687531|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687532|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687533|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687534|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687535|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687536|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687537|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687538|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687539|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687540|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
687541|NCT00303446|E2|Reported Event|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
687542|NCT00303446|E1|Reported Event|Placebo|Matched placebo, one tablet daily
687543|NCT00303329|B3|Baseline|Total|Total of all reporting groups
687544|NCT00303329|B2|Baseline|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
687545|NCT00303329|B1|Baseline|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
687546|NCT00303329|P2|Participant Flow|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
687547|NCT00303329|P1|Participant Flow|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
687548|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
687549|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
687550|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
687551|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
687552|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
687553|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
687554|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
687555|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
687556|NCT00303329|E2|Reported Event|Rare Anemias|Deferasirox (5-40 mg/kg/day)
687557|NCT00303329|E1|Reported Event|Beta-thalassemia|Deferasirox (5-40 mg/kg/day)
687558|NCT00303316|B3|Baseline|Total|Total of all reporting groups
687559|NCT00303316|B2|Baseline|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687560|NCT00303316|B1|Baseline|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687636|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
687637|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
687561|NCT00303316|P2|Participant Flow|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687562|NCT00303316|P1|Participant Flow|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687563|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687564|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687565|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687566|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687567|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687568|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687569|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687570|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687571|NCT00303316|E2|Reported Event|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687572|NCT00303316|E1|Reported Event|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
687573|NCT00303186|B1|Baseline|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687574|NCT00303186|P1|Participant Flow|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687575|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687576|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687577|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687578|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687579|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687638|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
687580|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687581|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687582|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687583|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687584|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687585|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687586|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687587|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687588|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687589|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687590|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687591|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687592|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687593|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687594|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687595|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687596|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687597|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687598|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687599|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687600|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687601|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687602|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687603|NCT00303186|E1|Reported Event|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
687604|NCT00303108|B4|Baseline|Total|Total of all reporting groups
687605|NCT00303108|B3|Baseline|D+C+H|Doxil, Carboplatin, and Herceptin
687606|NCT00303108|B2|Baseline|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
687607|NCT00303108|B1|Baseline|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
687608|NCT00303108|P3|Participant Flow|D+C+H|Doxil, Carboplatin, and Herceptin
687609|NCT00303108|P2|Participant Flow|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
687610|NCT00303108|P1|Participant Flow|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
687611|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
687612|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
687613|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
687614|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
687615|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
687616|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
687617|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
687618|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
687619|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
687620|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
687621|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
687622|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
687623|NCT00303108|E2|Reported Event|D+C+H|Doxil, Carboplatin, and Herceptin
687624|NCT00303108|E1|Reported Event|D+C and Taxane Naive or Pretreated|Doxil, Carboplatin and Taxane naive or pretreated.
687625|NCT00303069|B5|Baseline|Total|Total of all reporting groups
687626|NCT00303069|B4|Baseline|Placebo|Saline placebo single dose at baseline.
687627|NCT00303069|B3|Baseline|V710 90 μg|V710 90 μg single dose at baseline.
687628|NCT00303069|B2|Baseline|V710 30 μg|V710 30 μg single dose at baseline.
687629|NCT00303069|B1|Baseline|V710 5 μg|V710 5 μg single dose at baseline.
687630|NCT00303069|P4|Participant Flow|Placebo|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
687631|NCT00303069|P3|Participant Flow|V710 90 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
687632|NCT00303069|P2|Participant Flow|V710 30 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
687633|NCT00303069|P1|Participant Flow|V710 5 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
687634|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
687635|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
687640|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
687641|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
687642|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
687643|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
687644|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
687645|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
687646|NCT00303069|E4|Reported Event|Placebo|Saline placebo single dose at baseline.
687647|NCT00303069|E3|Reported Event|V710 90 μg|V710 90 μg single dose at baseline.
687648|NCT00303069|E2|Reported Event|V710 30 μg|V710 30 μg single dose at baseline.
687649|NCT00303069|E1|Reported Event|V710 5 μg|V710 5 μg single dose at baseline.
687650|NCT00302952|B3|Baseline|Total|Total of all reporting groups
687651|NCT00302952|B2|Baseline|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687652|NCT00302952|B1|Baseline|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687653|NCT00302952|P2|Participant Flow|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687654|NCT00302952|P1|Participant Flow|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687655|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687656|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687657|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687658|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687659|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687660|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687661|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687662|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687663|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687664|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687665|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687666|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687667|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687668|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687669|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687670|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687671|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687672|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687673|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687674|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687675|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687676|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687677|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687678|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687679|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687680|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687811|NCT00302211|E2|Reported Event|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
687681|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687682|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687683|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687684|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687685|NCT00302952|E2|Reported Event|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
687686|NCT00302952|E1|Reported Event|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
687687|NCT00302848|B4|Baseline|Total|Total of all reporting groups
687688|NCT00302848|B3|Baseline|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
687689|NCT00302848|B2|Baseline|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
687690|NCT00302848|B1|Baseline|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
687691|NCT00302848|P3|Participant Flow|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
687692|NCT00302848|P2|Participant Flow|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
687693|NCT00302848|P1|Participant Flow|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
687694|NCT00302848|O2|Outcome|Users of LNG|Women who use authorized oral contraceptives containing LNG prescribed by their gynecologist
687695|NCT00302848|O1|Outcome|Users of DRSP|Women who use authorized oral contraceptives containing DRSP prescribed by their gynecologist
687696|NCT00302848|E3|Reported Event|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
687697|NCT00302848|E2|Reported Event|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
687698|NCT00302848|E1|Reported Event|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
687699|NCT00302731|B5|Baseline|Total|Total of all reporting groups
687700|NCT00302731|B4|Baseline|Study Arm 4|"estradiol,progesterone~estradiol,progesterone: estradiol,progesterone"
687701|NCT00302731|B3|Baseline|Study Arm 3|"estriol 2.5mg, progesterone 100mg~estriol, progesterone: estriol 2.5mg, progesterone 100mg"
687702|NCT00302731|B2|Baseline|Study Arm 2|"Estradiol .5mg, estriol 210mg, progesterone 100mg~Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg"
687703|NCT00302731|B1|Baseline|Study Arm 1|"Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate~Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate"
687704|NCT00302731|P4|Participant Flow|Participants Randomized to Arm 4|"estradiol,progesterone~estradiol,progesterone: estradiol,progesterone"
687705|NCT00302731|P3|Participant Flow|Participants Randomized to Arm 3|"Participants in Arm 3 received compounded estriol 2.5mg, progesterone 100mg~estriol, progesterone: estriol 2.5mg, progesterone 100mg"
687706|NCT00302731|P2|Participant Flow|Participants Randomized to Arm 2|"Participants in Arm 2 received compounded Estradiol .5mg, estriol 210mg, progesterone 100mg~Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg"
687707|NCT00302731|P1|Participant Flow|Participants Randomized to Arm 1|Participants in Arm 1 received Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate
687708|NCT00302731|O4|Outcome|Study Arm 4|Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687709|NCT00302731|O3|Outcome|Study Arm 3|Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687710|NCT00302731|O2|Outcome|Study Arm 2|Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687711|NCT00302731|O1|Outcome|Study Arm 1|Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687712|NCT00302731|O4|Outcome|Study Arm 4|Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687713|NCT00302731|O3|Outcome|Study Arm 3|Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687714|NCT00302731|O2|Outcome|Study Arm 2|Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687715|NCT00302731|O1|Outcome|Study Arm 1|Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687716|NCT00302731|O4|Outcome|Study Arm 4|Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687717|NCT00302731|O3|Outcome|Study Arm 3|Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687718|NCT00302731|O2|Outcome|Study Arm 2|Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687719|NCT00302731|O1|Outcome|Study Arm 1|Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687720|NCT00302731|O4|Outcome|Study Arm 4|Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687721|NCT00302731|O3|Outcome|Study Arm 3|Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687722|NCT00302731|O2|Outcome|Study Arm 2|Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687723|NCT00302731|O1|Outcome|Study Arm 1|Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
687724|NCT00302731|E4|Reported Event|Study Arm 4|"estradiol,progesterone~estradiol,progesterone: estradiol,progesterone"
687725|NCT00302731|E3|Reported Event|Study Arm 3|"estriol 2.5mg, progesterone 100mg~estriol, progesterone: estriol 2.5mg, progesterone 100mg"
687726|NCT00302731|E2|Reported Event|Study Arm 2|"Estradiol .5mg, estriol 210mg, progesterone 100mg~Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg"
687727|NCT00302731|E1|Reported Event|Study Arm 1|"Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate~Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate"
687728|NCT00302718|B5|Baseline|Total|Total of all reporting groups
687729|NCT00302718|B4|Baseline|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687730|NCT00302718|B3|Baseline|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687731|NCT00302718|B2|Baseline|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687732|NCT00302718|B1|Baseline|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687733|NCT00302718|P4|Participant Flow|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687734|NCT00302718|P3|Participant Flow|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687735|NCT00302718|P2|Participant Flow|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687736|NCT00302718|P1|Participant Flow|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687737|NCT00302718|O2|Outcome|Intervention Group|This group is a combination of the physician and non-physician participants and the patients on the panels of the physician participants from the three intervention arms: physician-level, practice-level, and physician- and practice-level financial incentives.
687738|NCT00302718|O1|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687739|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687740|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687741|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687742|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687743|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687744|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687812|NCT00302211|E1|Reported Event|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
687745|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687746|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687747|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687748|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687749|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687750|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687751|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687752|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687753|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687754|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687755|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687756|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687757|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687758|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687759|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687760|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687761|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687762|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687763|NCT00302718|E4|Reported Event|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
687764|NCT00302718|E3|Reported Event|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
687765|NCT00302718|E2|Reported Event|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
687766|NCT00302718|E1|Reported Event|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
687767|NCT00302458|B1|Baseline|Healthy Volunteers|Healthy volunteers each received IR-MPH, OROS-MPH, and matched placebo (in four separate visits) in a four way crossover design.
687768|NCT00302458|P1|Participant Flow|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
687769|NCT00302458|O5|Outcome|OROS-MPH+ IR-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
687770|NCT00302458|O4|Outcome|OROS-MPH+OROS-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
687771|NCT00302458|O3|Outcome|IR-MPH +IR-MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
687772|NCT00302458|O2|Outcome|IR-MPH + OROS MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
687773|NCT00302458|O1|Outcome|Placebo- Placebo|Healthy volunteers received a placebo, followed by a placebo four hours later
687774|NCT00302458|E1|Reported Event|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
687775|NCT00302328|B4|Baseline|Total|Total of all reporting groups
687776|NCT00302328|B3|Baseline|tb Peeling|trypan blue (tb) peeling
687777|NCT00302328|B2|Baseline|ICG Peeling|indocyanine green (ICG) peeling
687778|NCT00302328|B1|Baseline|no Peeling|no peeling used
687779|NCT00302328|P3|Participant Flow|tb Peeling|trypan blue (tb) peeling
687780|NCT00302328|P2|Participant Flow|ICG Peeling|indocyanine (ICG) peeling
687781|NCT00302328|P1|Participant Flow|no Peeling|no peeling used
687782|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
687783|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
687784|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
687785|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assited ilm peeling
687786|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
687787|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
687788|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
687789|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg-assisted ilm peeling
687790|NCT00302328|O1|Outcome|no Peeling|Vitrectomy without peeling
687791|NCT00302328|E3|Reported Event|tb Peeling|vitrectomy with trypan blue assited ilm peeling
687792|NCT00302328|E2|Reported Event|ICG Peeling|vitrectomy with icg assited ilm peeling
687793|NCT00302328|E1|Reported Event|no Peeling|vitrectomy without ilm peeling
687794|NCT00302211|B4|Baseline|Total|Total of all reporting groups
687795|NCT00302211|B3|Baseline|Placebo 6×/Day + Sildenafil +/- Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
687796|NCT00302211|B2|Baseline|Iloprost 4×/Day + Placebo 2x/Day + Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
687797|NCT00302211|B1|Baseline|Iloprost(5 μg) 6×/Day Plus Sildenafil +/- Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
687798|NCT00302211|P5|Participant Flow|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
687799|NCT00302211|P4|Participant Flow|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
687800|NCT00302211|P3|Participant Flow|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
687801|NCT00302211|P2|Participant Flow|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
687802|NCT00302211|P1|Participant Flow|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
687803|NCT00302211|O5|Outcome|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
687804|NCT00302211|O4|Outcome|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
687805|NCT00302211|O3|Outcome|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
687806|NCT00302211|O2|Outcome|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
687807|NCT00302211|O1|Outcome|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
687808|NCT00302211|E5|Reported Event|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
687809|NCT00302211|E4|Reported Event|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
687810|NCT00302211|E3|Reported Event|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
687849|NCT00302081|O3|Outcome|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
687813|NCT00302159|B1|Baseline|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687814|NCT00302159|P1|Participant Flow|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687815|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687816|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687817|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687818|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687819|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687820|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687821|NCT00302159|E1|Reported Event|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
687822|NCT00302133|B3|Baseline|Total|Total of all reporting groups
687823|NCT00302133|B2|Baseline|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
687824|NCT00302133|B1|Baseline|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
687825|NCT00302133|P2|Participant Flow|Placebo|"Placebo add on to valproate open label~Placebo one capsule daily for 12 weeks"
687826|NCT00302133|P1|Participant Flow|Naltrexone|"Naltrexone add on to valproate open label~Naltrexone Hydrochloride 50 mg daily for 12 weeks"
687827|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
687828|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
687829|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
687830|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
687831|NCT00302133|E2|Reported Event|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
687832|NCT00302133|E1|Reported Event|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
687833|NCT00302107|B3|Baseline|Total|Total of all reporting groups
687834|NCT00302107|B2|Baseline|Placebo|Placebo up to three tablets qhs
687835|NCT00302107|B1|Baseline|Mirtazapine|Mirtazapine up to 45 mg/qhs as tolerated
687836|NCT00302107|P2|Participant Flow|Placebo|Placebo up to three pills qhs
687837|NCT00302107|P1|Participant Flow|Mirtazapine|Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.
687838|NCT00302107|O2|Outcome|Placebo|Placebo up to 3 tablets qhs
687839|NCT00302107|O1|Outcome|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
687840|NCT00302107|E2|Reported Event|Placebo|Placebo up to 3 tablets qhs
687841|NCT00302107|E1|Reported Event|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
687842|NCT00302081|B4|Baseline|Total|Total of all reporting groups
687843|NCT00302081|B3|Baseline|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
687844|NCT00302081|B2|Baseline|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
687845|NCT00302081|B1|Baseline|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
687846|NCT00302081|P3|Participant Flow|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
687847|NCT00302081|P2|Participant Flow|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
687848|NCT00302081|P1|Participant Flow|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
687850|NCT00302081|O2|Outcome|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
687851|NCT00302081|O1|Outcome|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
687852|NCT00302081|E3|Reported Event|PEG2b 1.5/R*(16 Weeks)|
687853|NCT00302081|E2|Reported Event|PEG2b 1.0/R*(24 Weeks)|
687854|NCT00302081|E1|Reported Event|PEG2b 1.5/R*(24 Weeks)|
687855|NCT00302068|B4|Baseline|Total|Total of all reporting groups
687856|NCT00302068|B3|Baseline|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687857|NCT00302068|B2|Baseline|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687858|NCT00302068|B1|Baseline|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687859|NCT00302068|P3|Participant Flow|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687860|NCT00302068|P2|Participant Flow|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687861|NCT00302068|P1|Participant Flow|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687862|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687863|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687864|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687865|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687866|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687867|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687868|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687869|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687870|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687871|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687872|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
688105|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
687873|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687874|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687875|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687876|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687877|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects..
687878|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687879|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687880|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687881|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687882|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687883|NCT00302068|E3|Reported Event|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687884|NCT00302068|E2|Reported Event|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
687885|NCT00302068|E1|Reported Event|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
687886|NCT00302055|B3|Baseline|Total|Total of all reporting groups
687887|NCT00302055|B2|Baseline|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
687888|NCT00302055|B1|Baseline|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
687889|NCT00302055|P2|Participant Flow|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
687890|NCT00302055|P1|Participant Flow|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
687891|NCT00302055|O2|Outcome|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
687892|NCT00302055|O1|Outcome|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
687893|NCT00302055|E2|Reported Event|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
687894|NCT00302055|E1|Reported Event|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
687895|NCT00302042|B3|Baseline|Total|Total of all reporting groups
687896|NCT00302042|B2|Baseline|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
687897|NCT00302042|B1|Baseline|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
687898|NCT00302042|P2|Participant Flow|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
687927|NCT00301873|P1|Participant Flow|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
687899|NCT00302042|P1|Participant Flow|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
687900|NCT00302042|O2|Outcome|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
687901|NCT00302042|O1|Outcome|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
687902|NCT00302042|E2|Reported Event|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
687903|NCT00302042|E1|Reported Event|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
687904|NCT00302003|B1|Baseline|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
687905|NCT00302003|P1|Participant Flow|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
687906|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
687907|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
687908|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
687909|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
687910|NCT00302003|E1|Reported Event|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
687911|NCT00301964|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687912|NCT00301964|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687913|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687914|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687915|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687916|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687917|NCT00301964|O6|Outcome|Grade 5 (CTCAE v 3.0)|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
687918|NCT00301964|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
687919|NCT00301964|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
687920|NCT00301964|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
687921|NCT00301964|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
687922|NCT00301964|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
687923|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687924|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687925|NCT00301964|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
687926|NCT00301873|B1|Baseline|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
687928|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
687929|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
687930|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
687931|NCT00301873|E1|Reported Event|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
687932|NCT00301834|B1|Baseline|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
687933|NCT00301834|P1|Participant Flow|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
687934|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
687935|NCT00301834|O2|Outcome|CMV Seropositive Participants|"seropositivity means the presence of anti-CMV IgG, indicating past infection by the virus"
687936|NCT00301834|O1|Outcome|CMV Seronegative Participants|"seronegativity means no detected presence of anti-CMV IgG, indicating no past infection by the virus"
687937|NCT00301834|O1|Outcome|Single Arm|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
687938|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
687939|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
687940|NCT00301834|E1|Reported Event|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
687941|NCT00301821|B1|Baseline|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
687942|NCT00301821|P1|Participant Flow|Epratuzumab + Rituximab + CHOP|One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
687943|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
687944|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
687945|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
687946|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
687947|NCT00301821|E1|Reported Event|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
687948|NCT00301808|B1|Baseline|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
687949|NCT00301808|P1|Participant Flow|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
687950|NCT00301808|O1|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
687951|NCT00301808|O1|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
687970|NCT00301366|B1|Baseline|Entered Study|
687971|NCT00301366|P1|Participant Flow|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
687972|NCT00301366|O1|Outcome|Alpha-1 MP Treatment Group|
687952|NCT00301808|O1|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
687953|NCT00301808|O1|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
687954|NCT00301808|E1|Reported Event|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
687955|NCT00301756|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
687956|NCT00301756|P1|Participant Flow|Treatment (Belinostat / Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
687957|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
687958|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
687959|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
687960|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
687961|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
687962|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
687963|NCT00301756|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
687964|NCT00301418|B1|Baseline|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
687965|NCT00301418|P1|Participant Flow|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
687966|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
687967|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
687968|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
687969|NCT00301418|E1|Reported Event|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
687973|NCT00301366|E1|Reported Event|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
687974|NCT00301262|B3|Baseline|Total|Total of all reporting groups
687975|NCT00301262|B2|Baseline|Start : DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
687976|NCT00301262|B1|Baseline|Start : DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).
687977|NCT00301262|P2|Participant Flow|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
687978|NCT00301262|P1|Participant Flow|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
687979|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
687980|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
687981|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
687982|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
687983|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
687984|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
687985|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
687986|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
687987|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
687988|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
687989|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
687990|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
687991|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
687992|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
687993|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
687994|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
687995|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
687996|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
687997|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
687998|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
687999|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688000|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688001|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
688002|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688003|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688004|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688005|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
688006|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688007|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688008|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688009|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
688010|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688011|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688012|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688013|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
688014|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688015|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688016|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688017|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
688018|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688019|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688020|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688021|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
688022|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688023|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688024|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688025|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
688026|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688027|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
688028|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
688029|NCT00301262|O2|Outcome|DB Placebo Baseline to < Week 8|
688030|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
688031|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
688032|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
688033|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
688034|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
688035|NCT00301262|O2|Outcome|DB Placebo/ OL Viagra|
688036|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
688037|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688038|NCT00301262|O3|Outcome|DB Placebo Week 8|
688039|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688040|NCT00301262|O1|Outcome|DB Viagra Week 8|
688041|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688042|NCT00301262|O3|Outcome|DB Placebo Week 8|
688043|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688044|NCT00301262|O1|Outcome|DB Viagra Week 8|
688053|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
688054|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
688055|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
688056|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
688057|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
688058|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
688059|NCT00301262|O2|Outcome|DB Placebo|
688060|NCT00301262|O1|Outcome|DB Viagra|
688061|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
688062|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
688063|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
688064|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
688065|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
688066|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
688067|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
688068|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
688069|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
688070|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
688071|NCT00301262|O2|Outcome|Week 8 DB Placebo|
688072|NCT00301262|O1|Outcome|Week 8 DB Viagra|
688073|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
688074|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
688075|NCT00301262|O2|Outcome|Week 8 DB Placebo|
688076|NCT00301262|O1|Outcome|Week 8 DB Viagra|
688077|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
688078|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
688079|NCT00301262|O2|Outcome|Week 8 DB Placebo|
688080|NCT00301262|O1|Outcome|Week 8 DB Viagra|
688081|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688082|NCT00301262|O3|Outcome|DB Placebo Week 8|
688083|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688084|NCT00301262|O1|Outcome|DB Viagra Week 8|
688085|NCT00301262|O2|Outcome|DB Placebo|
688086|NCT00301262|O1|Outcome|DB Viagra|
688087|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688088|NCT00301262|O3|Outcome|DB Placebo Week 8|
688089|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688090|NCT00301262|O1|Outcome|DB Viagra Week 8|
688091|NCT00301262|O2|Outcome|DB Placebo|
688092|NCT00301262|O1|Outcome|DB Viagra|
688093|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688094|NCT00301262|O3|Outcome|DB Placebo Week 8|
688095|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688096|NCT00301262|O1|Outcome|DB Viagra Week 8|
688097|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688098|NCT00301262|O3|Outcome|DB Placebo Week 8|
688099|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688106|NCT00301262|O3|Outcome|DB Placebo Week 8|
688107|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688108|NCT00301262|O1|Outcome|DB Viagra Week 8|
688109|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688110|NCT00301262|O3|Outcome|DB Placebo Week 8|
688111|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688112|NCT00301262|O1|Outcome|DB Viagra Week 8|
688113|NCT00301262|O2|Outcome|DB Placebo|
688114|NCT00301262|O1|Outcome|DB Viagra|
688115|NCT00301262|O2|Outcome|DB Placebo|
688116|NCT00301262|O1|Outcome|DB Viagra|
688117|NCT00301262|O2|Outcome|DB Placebo|
688118|NCT00301262|O1|Outcome|DB Viagra|
688119|NCT00301262|O2|Outcome|DB Placebo|
688120|NCT00301262|O1|Outcome|DB Viagra|
688121|NCT00301262|O2|Outcome|DB Placebo|
688122|NCT00301262|O1|Outcome|DB Viagra|
688123|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688124|NCT00301262|O3|Outcome|DB Placebo Week 8|
688125|NCT00301262|O2|Outcome|DB Viagra /OL Viagra Week 14|
688126|NCT00301262|O1|Outcome|DB Viagra Week 8|
688127|NCT00301262|O2|Outcome|DB Placebo|
688128|NCT00301262|O1|Outcome|DB Viagra|
688129|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
688130|NCT00301262|O3|Outcome|DB Placebo Week 8|
688131|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
688132|NCT00301262|O1|Outcome|DB Viagra Week 8|
688133|NCT00301262|O2|Outcome|DB Placebo|
688134|NCT00301262|O1|Outcome|DB Viagra|
688135|NCT00301080|B1|Baseline|All Participants (Original Version)|All 7 patients enrolled were during the original version of the study design (2 arms: d-cycloserine 250mg vs. placebo - twice daily for 4 weeks). Since the study went on to change design and then terminate prior to completing accrual, it is not useful to report baseline measures by the original arms/groups.
688136|NCT00301080|P5|Participant Flow|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 12 weeks.
688137|NCT00301080|P4|Participant Flow|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
688138|NCT00301080|P3|Participant Flow|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
688139|NCT00301080|P2|Participant Flow|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688140|NCT00301080|P1|Participant Flow|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
688141|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688142|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
688143|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
688144|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688145|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
688146|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688147|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
688148|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
688149|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688150|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
688151|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688152|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
688153|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
688154|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688155|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
688156|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688157|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
688158|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
688159|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688160|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
688161|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688162|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
688163|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
688164|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
688165|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
688166|NCT00301080|E2|Reported Event|D-cycloserine 250mg|
688167|NCT00301080|E1|Reported Event|Placebo (Original Version)|
689576|NCT00297102|P2|Participant Flow|Placebo|once daily
688168|NCT00301028|B1|Baseline|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
688169|NCT00301028|P1|Participant Flow|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin Area Under the Curve (AUC) 2 and Paclitaxel 135 mg/m^2 for 6 courses.
688170|NCT00301028|O1|Outcome|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
688171|NCT00301028|E1|Reported Event|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
688172|NCT00300885|B3|Baseline|Total|Total of all reporting groups
688173|NCT00300885|B2|Baseline|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688174|NCT00300885|B1|Baseline|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688175|NCT00300885|P2|Participant Flow|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688176|NCT00300885|P1|Participant Flow|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688177|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688178|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688179|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688180|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688181|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688182|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688183|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688184|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688185|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688186|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688187|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688250|NCT00300495|O2|Outcome|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
688188|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688189|NCT00300885|E2|Reported Event|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
688190|NCT00300885|E1|Reported Event|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
688191|NCT00300781|B3|Baseline|Total|Total of all reporting groups
688192|NCT00300781|B2|Baseline|Neratinib 240, No Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688193|NCT00300781|B1|Baseline|Neratinib 240, Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer with prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688194|NCT00300781|P2|Participant Flow|Neratinib 240, No Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688195|NCT00300781|P1|Participant Flow|Neratinib 240, Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer with prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688196|NCT00300781|O2|Outcome|Neratinib 240, No Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688197|NCT00300781|O1|Outcome|Neratinib 240, Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer with prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688198|NCT00300781|O2|Outcome|Neratinib 240, No Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688199|NCT00300781|O1|Outcome|Neratinib 240, Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer with prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688200|NCT00300781|O2|Outcome|Neratinib 240, No Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688201|NCT00300781|O1|Outcome|Neratinib 240, Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer with prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688202|NCT00300781|O2|Outcome|Neratinib 240, No Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688203|NCT00300781|O1|Outcome|Neratinib 240, Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer with prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688204|NCT00300781|E2|Reported Event|Neratinib 240, No Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer, with no prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688205|NCT00300781|E1|Reported Event|Neratinib 240, Prior Trastuzumab|"Patients with confirmed HER2+ breast cancer with prior trastuzumab treatment.~HKI-272 (neratinib): 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen."
688206|NCT00300755|B4|Baseline|Total|Total of all reporting groups
688207|NCT00300755|B3|Baseline|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
688208|NCT00300755|B2|Baseline|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
688209|NCT00300755|B1|Baseline|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
688210|NCT00300755|P3|Participant Flow|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
688211|NCT00300755|P2|Participant Flow|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
688212|NCT00300755|P1|Participant Flow|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
688313|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688213|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
688214|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
688215|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
688216|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
688217|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
688218|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
688219|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
688220|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
688221|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
688222|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
688223|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
688224|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
688225|NCT00300755|E3|Reported Event|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
688226|NCT00300755|E2|Reported Event|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
688227|NCT00300755|E1|Reported Event|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
688228|NCT00300742|B1|Baseline|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
688229|NCT00300742|P1|Participant Flow|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
688230|NCT00300742|O1|Outcome|Topiramate/BBCET|Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
688231|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
688232|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
688233|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
688234|NCT00300742|O1|Outcome|Topiramate/BBCET|Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
688235|NCT00300742|E1|Reported Event|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
688236|NCT00300677|B1|Baseline|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
688237|NCT00300677|P1|Participant Flow|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
688238|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
688239|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
688240|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
688241|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
688242|NCT00300677|E1|Reported Event|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
688243|NCT00300495|B3|Baseline|Total|Total of all reporting groups
688244|NCT00300495|B2|Baseline|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
688245|NCT00300495|B1|Baseline|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered"
688246|NCT00300495|P2|Participant Flow|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
688247|NCT00300495|P1|Participant Flow|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
688248|NCT00300495|O2|Outcome|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
688249|NCT00300495|O1|Outcome|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
688251|NCT00300495|O1|Outcome|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
688252|NCT00300495|E2|Reported Event|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
688253|NCT00300495|E1|Reported Event|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
688254|NCT00300482|B7|Baseline|Total|Total of all reporting groups
688255|NCT00300482|B6|Baseline|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688256|NCT00300482|B5|Baseline|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688257|NCT00300482|B4|Baseline|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688258|NCT00300482|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
688259|NCT00300482|B2|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688260|NCT00300482|B1|Baseline|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688261|NCT00300482|P6|Participant Flow|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688262|NCT00300482|P5|Participant Flow|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688263|NCT00300482|P4|Participant Flow|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688264|NCT00300482|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
688265|NCT00300482|P2|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688266|NCT00300482|P1|Participant Flow|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688267|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688268|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688269|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688270|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688271|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688272|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688273|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688274|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688275|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688276|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688277|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688278|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688279|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688280|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688281|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688282|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688283|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688284|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688285|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688286|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688287|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688288|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688289|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688290|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688291|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688292|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688293|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688294|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688295|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688296|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688297|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688298|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688299|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688300|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688301|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688302|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688303|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688304|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688305|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688306|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688307|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688308|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688309|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688310|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688311|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688312|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688314|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688315|NCT00300482|E6|Reported Event|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
688316|NCT00300482|E5|Reported Event|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
688317|NCT00300482|E4|Reported Event|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
688318|NCT00300482|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
688319|NCT00300482|E2|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
688320|NCT00300482|E1|Reported Event|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
688321|NCT00300469|B7|Baseline|Total|Total of all reporting groups
688322|NCT00300469|B6|Baseline|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688323|NCT00300469|B5|Baseline|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688324|NCT00300469|B4|Baseline|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688325|NCT00300469|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
688326|NCT00300469|B2|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688327|NCT00300469|B1|Baseline|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688328|NCT00300469|P6|Participant Flow|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688329|NCT00300469|P5|Participant Flow|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688330|NCT00300469|P4|Participant Flow|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688331|NCT00300469|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
688332|NCT00300469|P2|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688333|NCT00300469|P1|Participant Flow|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688334|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688335|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688336|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688337|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688338|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688339|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688340|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688341|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688342|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688343|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688344|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688345|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688346|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688347|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688348|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688349|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688350|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688351|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688352|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688353|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688354|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688355|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688356|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688357|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688358|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688359|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688360|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688361|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688362|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688363|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688364|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688365|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688366|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688367|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688368|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688369|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688370|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688371|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688372|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688373|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688374|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688375|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688376|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688377|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
689840|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
688378|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688379|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688380|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688381|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688382|NCT00300469|E6|Reported Event|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
688383|NCT00300469|E5|Reported Event|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
688384|NCT00300469|E4|Reported Event|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
688385|NCT00300469|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
688386|NCT00300469|E2|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
688387|NCT00300469|E1|Reported Event|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
688388|NCT00300456|B7|Baseline|Total|Total of all reporting groups
688389|NCT00300456|B6|Baseline|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688390|NCT00300456|B5|Baseline|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688391|NCT00300456|B4|Baseline|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688392|NCT00300456|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
688393|NCT00300456|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688394|NCT00300456|B1|Baseline|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688395|NCT00300456|P6|Participant Flow|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688396|NCT00300456|P5|Participant Flow|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688397|NCT00300456|P4|Participant Flow|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688398|NCT00300456|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
688399|NCT00300456|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688400|NCT00300456|P1|Participant Flow|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688401|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688402|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688403|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688404|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688405|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688406|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688407|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688408|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688409|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688410|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688411|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688412|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688413|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688414|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688415|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688416|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688417|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688418|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688419|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688420|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688421|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688422|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688423|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688424|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688425|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688426|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688427|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688428|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688429|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688430|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688431|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688432|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688433|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688434|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688435|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688436|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688437|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688438|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688439|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688440|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688441|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688442|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688443|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688444|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688445|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688446|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
688447|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688448|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688449|NCT00300456|E6|Reported Event|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
688450|NCT00300456|E5|Reported Event|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
688451|NCT00300456|E4|Reported Event|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
688452|NCT00300456|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
688453|NCT00300456|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
688454|NCT00300456|E1|Reported Event|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
688455|NCT00300430|B4|Baseline|Total|Total of all reporting groups
688456|NCT00300430|B3|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688457|NCT00300430|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688458|NCT00300430|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688459|NCT00300430|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688460|NCT00300430|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688461|NCT00300430|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688462|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688463|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688464|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688465|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688466|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688467|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688468|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688469|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688470|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688471|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688472|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688473|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688474|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688475|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688476|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688477|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688478|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688479|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688480|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688481|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688482|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688483|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688484|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688485|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688486|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688487|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688488|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688489|NCT00300430|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
688490|NCT00300430|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
688491|NCT00300430|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
688492|NCT00300391|B3|Baseline|Total|Total of all reporting groups
688493|NCT00300391|B2|Baseline|Placebo|Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
688494|NCT00300391|B1|Baseline|Haloperidol|Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
688495|NCT00300391|P2|Participant Flow|Placebo|Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
688496|NCT00300391|P1|Participant Flow|Haloperidol|Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
688497|NCT00300391|O3|Outcome|No Delirium|
688498|NCT00300391|O2|Outcome|Persistent Coma|
688580|NCT00300235|E1|Reported Event|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
688499|NCT00300391|O1|Outcome|Delirium|"Once diagnosed as delirious, randomized to haloperidol 5 mg IV~haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay."
688500|NCT00300391|O3|Outcome|No Delirium|
688501|NCT00300391|O2|Outcome|Persistent Coma|
688502|NCT00300391|O1|Outcome|Delirium|"Once diagnosed as delirious, randomized to haloperidol 5 mg IV~haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay."
688503|NCT00300391|O3|Outcome|No Delirium|
688504|NCT00300391|O2|Outcome|Persistent Coma|
688505|NCT00300391|O1|Outcome|Delirium|"Once diagnosed as delirious, randomized to haloperidol 5 mg IV~haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay."
688506|NCT00300391|O3|Outcome|No Delirium|
688507|NCT00300391|O2|Outcome|Persistent Coma|
688508|NCT00300391|O1|Outcome|Delirium|"Once diagnosed as delirious, randomized to haloperidol 5 mg IV~haloperidol: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay."
688509|NCT00300391|E2|Reported Event|Placebo|Once delirium was diagnosed, subjects were randomized to identical placebo, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
688510|NCT00300391|E1|Reported Event|Haloperidol|Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
688511|NCT00300365|B3|Baseline|Total|Total of all reporting groups
688512|NCT00300365|B2|Baseline|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
688513|NCT00300365|B1|Baseline|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
688514|NCT00300365|P2|Participant Flow|Active Pioglitazone + Open-Label Niacin + Aspirin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and aspirin 325 mg. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
688515|NCT00300365|P1|Participant Flow|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and aspirin 325 mg
688516|NCT00300365|O2|Outcome|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
688517|NCT00300365|O1|Outcome|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
688518|NCT00300365|E2|Reported Event|Active Pioglitazone + Open-Label Niacin + Asprin|Subjects receiving 45 mg/day active pioglitazone in combination with niacin ER 2.0 g/daily and 325 mg aspirin. Subjects received 30mg/day pioglitazone for 6 weeks, followed by 45 mg/day for another 6 weeks
688519|NCT00300365|E1|Reported Event|Pioglitazone Placebo + Open-Label Niacin + Aspirin|Subjects receiving pioglitazone placebo in combination with niacin ER 2.0 g/daily and 325 mg aspirin
688520|NCT00300274|B4|Baseline|Total|Total of all reporting groups
688521|NCT00300274|B3|Baseline|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688522|NCT00300274|B2|Baseline|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688523|NCT00300274|B1|Baseline|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688524|NCT00300274|P3|Participant Flow|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688525|NCT00300274|P2|Participant Flow|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688526|NCT00300274|P1|Participant Flow|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688527|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688528|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688529|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688530|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688531|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688532|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688533|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688534|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688535|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688536|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688537|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688538|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688539|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688540|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688541|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688542|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688543|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688544|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688545|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688581|NCT00299975|B4|Baseline|Total|Total of all reporting groups
688582|NCT00299975|B3|Baseline|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688546|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688547|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688548|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688549|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688550|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688551|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688552|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688553|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688554|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688555|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688556|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688557|NCT00300274|E3|Reported Event|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
688558|NCT00300274|E2|Reported Event|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
688559|NCT00300274|E1|Reported Event|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
688560|NCT00300235|B6|Baseline|Total|Total of all reporting groups
688561|NCT00300235|B5|Baseline|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
688562|NCT00300235|B4|Baseline|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
688563|NCT00300235|B3|Baseline|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
688564|NCT00300235|B2|Baseline|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
688565|NCT00300235|B1|Baseline|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
688566|NCT00300235|P5|Participant Flow|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
688567|NCT00300235|P4|Participant Flow|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
688568|NCT00300235|P3|Participant Flow|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
688569|NCT00300235|P2|Participant Flow|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
688570|NCT00300235|P1|Participant Flow|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
688571|NCT00300235|O5|Outcome|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
688572|NCT00300235|O4|Outcome|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
688573|NCT00300235|O3|Outcome|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
688574|NCT00300235|O2|Outcome|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
688575|NCT00300235|O1|Outcome|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
688576|NCT00300235|E5|Reported Event|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
688577|NCT00300235|E4|Reported Event|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
688578|NCT00300235|E3|Reported Event|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
688579|NCT00300235|E2|Reported Event|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
688583|NCT00299975|B2|Baseline|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688584|NCT00299975|B1|Baseline|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688585|NCT00299975|P3|Participant Flow|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688586|NCT00299975|P2|Participant Flow|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688587|NCT00299975|P1|Participant Flow|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688588|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688589|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688590|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688591|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688592|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688593|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688594|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688595|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688596|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688597|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688598|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688599|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688600|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688601|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688602|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688603|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688604|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688605|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688606|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688607|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688608|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688609|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688610|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688611|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688612|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688613|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688614|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688615|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688616|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688617|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688618|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688619|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688620|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688621|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688622|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688623|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688624|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688625|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688626|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688627|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688628|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688629|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688630|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688631|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688632|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688633|NCT00299975|E3|Reported Event|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688634|NCT00299975|E2|Reported Event|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688635|NCT00299975|E1|Reported Event|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
688636|NCT00299741|B1|Baseline|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
688637|NCT00299741|P1|Participant Flow|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib administered orally at a dosage of 37.5 mg once daily
688638|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
688639|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
688640|NCT00299741|E1|Reported Event|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
688641|NCT00299702|B3|Baseline|Total|Total of all reporting groups
688642|NCT00299702|B2|Baseline|Abilify|10-30 mg once daily oral for 104 weeks
688643|NCT00299702|B1|Baseline|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
688644|NCT00299702|P2|Participant Flow|Abilify|10-30 mg once daily oral for 104 weeks
688645|NCT00299702|P1|Participant Flow|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
688646|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
688647|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
688648|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
688649|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
688650|NCT00299702|E2|Reported Event|Abilify|10-30 mg once daily oral for 104 weeks
688651|NCT00299702|E1|Reported Event|RISPERDAL CONSTA|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
688652|NCT00299689|B1|Baseline|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
688653|NCT00299689|P1|Participant Flow|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
688654|NCT00299689|O1|Outcome|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
688655|NCT00299689|E1|Reported Event|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
688656|NCT00299546|B4|Baseline|Total|Total of all reporting groups
689139|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
688657|NCT00299546|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
688658|NCT00299546|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
688659|NCT00299546|B1|Baseline|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
688660|NCT00299546|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
688661|NCT00299546|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
688662|NCT00299546|P1|Participant Flow|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
688663|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
688664|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
688665|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688666|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688667|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
688668|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
688669|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688670|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688671|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
688672|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
688673|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688674|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688675|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
688676|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
688677|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688678|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688679|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
688680|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
688681|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688682|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
688683|NCT00299546|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.
688684|NCT00299546|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
688685|NCT00299546|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
688686|NCT00299494|B7|Baseline|Total|Total of all reporting groups
688687|NCT00299494|B6|Baseline|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688688|NCT00299494|B5|Baseline|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688689|NCT00299494|B4|Baseline|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688690|NCT00299494|B3|Baseline|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688691|NCT00299494|B2|Baseline|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688692|NCT00299494|B1|Baseline|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688693|NCT00299494|P6|Participant Flow|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with either refractory aggressive or intermediate B-cell non-Hodgkin's lymphoma (NHL) received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688694|NCT00299494|P5|Participant Flow|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with diffuse large B-cell lymphoma (DLBCL) received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688695|NCT00299494|P4|Participant Flow|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the maximum tolerated dose (MTD) determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688696|NCT00299494|P3|Participant Flow|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688697|NCT00299494|P2|Participant Flow|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
689140|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689841|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
688698|NCT00299494|P1|Participant Flow|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via intravenous (IV) infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688699|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688700|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688701|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688702|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688703|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688704|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688705|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688706|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688707|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688708|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688709|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688819|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
689842|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
688710|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688711|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688712|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688713|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the first cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688714|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688715|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688716|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688717|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688718|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688719|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688720|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688721|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
689141|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
688722|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688723|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688724|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688725|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688726|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688727|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688728|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688729|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688730|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688731|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688732|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688733|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
689142|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
688734|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688735|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688736|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688737|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688738|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma, DLBCL, and refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688739|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688740|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688741|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688742|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688743|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688744|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688745|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688746|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688778|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
689482|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
688747|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688748|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688749|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688750|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688751|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688752|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688753|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688754|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688755|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688756|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688757|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688758|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688759|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688760|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688761|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688762|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
689143|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
688763|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688764|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688765|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688766|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688767|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688768|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688769|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688770|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688771|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688772|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688773|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688774|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688775|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688776|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688777|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
689483|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
688779|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688780|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688781|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688782|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688783|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688784|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688785|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688786|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688787|NCT00299494|O6|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688788|NCT00299494|O5|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688789|NCT00299494|O4|Outcome|INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688790|NCT00299494|O3|Outcome|INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688791|NCT00299494|O2|Outcome|INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688792|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688793|NCT00299494|O1|Outcome|INOTUZUMAB OZOGAMICIN + RITUXIMAB 375 MG/M^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin (0.8 mg/m^2, 1.3 mg/m^2, or 1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the participant refused further treatment.
688794|NCT00299494|E6|Reported Event|Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Refractory|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with either refractory aggressive or intermediate B-cell NHL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
689843|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
688795|NCT00299494|E5|Reported Event|Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 DLBCL|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with DLBCL received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688796|NCT00299494|E4|Reported Event|Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Follicular|Participants received the MTD determined in the dose escalation phase; MTD determination in the dose escalation phase was based on toxicities during the 1st cycle. Participants with follicular lymphoma received rituximab 375 mg/m^2 via IV infusion on Day 1 and the MTD of inotuzumab ozogamicin (1.8 mg/m^2) via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688797|NCT00299494|E3|Reported Event|Inotuzumab Ozogamicin 1.8 mg/m^2+ Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688798|NCT00299494|E2|Reported Event|Inotuzumab Ozogamicin 1.3 mg/m^2+ Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.3 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688799|NCT00299494|E1|Reported Event|Inotuzumab Ozogamicin 0.8 mg/m^2+ Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 via IV infusion on Day 1 and inotuzumab ozogamicin 0.8 mg/m^2 via IV infusion on Day 2 of each 28-day cycle for up to 8 cycles unless there was evidence of progressive disease, unacceptable toxicity, or the subject refused further treatment.
688800|NCT00299416|B1|Baseline|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
688801|NCT00299416|P1|Participant Flow|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
688802|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
688803|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
688804|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
688805|NCT00299416|E1|Reported Event|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
688806|NCT00299221|B3|Baseline|Total|Total of all reporting groups
688807|NCT00299221|B2|Baseline|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
688808|NCT00299221|B1|Baseline|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
688809|NCT00299221|P2|Participant Flow|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
688810|NCT00299221|P1|Participant Flow|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
688811|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
688812|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
688813|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
688814|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
688815|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
688816|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
688817|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
688818|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
689144|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
688820|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
688821|NCT00299221|E2|Reported Event|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
688822|NCT00299221|E1|Reported Event|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
688823|NCT00299156|B4|Baseline|Total|Total of all reporting groups
688824|NCT00299156|B3|Baseline|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688825|NCT00299156|B2|Baseline|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688826|NCT00299156|B1|Baseline|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688827|NCT00299156|P3|Participant Flow|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688828|NCT00299156|P2|Participant Flow|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688829|NCT00299156|P1|Participant Flow|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688830|NCT00299156|O3|Outcome|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688831|NCT00299156|O2|Outcome|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688832|NCT00299156|O1|Outcome|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688833|NCT00299156|E3|Reported Event|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688834|NCT00299156|E2|Reported Event|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688835|NCT00299156|E1|Reported Event|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
688836|NCT00299130|B4|Baseline|Total|Total of all reporting groups
688837|NCT00299130|B3|Baseline|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688838|NCT00299130|B2|Baseline|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688839|NCT00299130|B1|Baseline|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688840|NCT00299130|P3|Participant Flow|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688841|NCT00299130|P2|Participant Flow|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688842|NCT00299130|P1|Participant Flow|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
689100|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689484|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
688843|NCT00299130|O1|Outcome|Rituximab + MTX|"Participants received 0.5 g or 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688844|NCT00299130|O2|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688845|NCT00299130|O1|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688846|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688847|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688848|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688849|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688850|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688851|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688852|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688853|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688954|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689485|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
688854|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688855|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688856|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688857|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688858|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688859|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688860|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688861|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688862|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688863|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688864|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688887|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688865|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688866|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688867|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688868|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688869|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688870|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688871|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688872|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688873|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688874|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688875|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688899|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688876|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688877|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688878|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688879|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688880|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688881|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688882|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688883|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688884|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688885|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688886|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688949|NCT00299104|P1|Participant Flow|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689145|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
688888|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688889|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688890|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688891|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688892|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688893|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688894|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688895|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688896|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688897|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688898|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688950|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689486|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
688900|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688901|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688902|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688903|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688904|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688905|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688906|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688907|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688908|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688909|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688910|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688951|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689487|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
688911|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688912|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688913|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688914|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688915|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688916|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688917|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688918|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688919|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688920|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688921|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688952|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689146|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
688922|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688923|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688924|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688925|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688926|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688927|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688928|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688929|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688930|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688931|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688932|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688953|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689396|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
688933|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688934|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688935|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688936|NCT00299130|E7|Reported Event|Rituximab 2 x 1.0 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
688937|NCT00299130|E6|Reported Event|Rituximab 2 x 0.5 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
688938|NCT00299130|E5|Reported Event|Switch Population: Rituximab|Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab.
688939|NCT00299130|E4|Reported Event|Switch Population: Placebo + MTX|Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24.
688940|NCT00299130|E3|Reported Event|Rituximab 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688941|NCT00299130|E2|Reported Event|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688942|NCT00299130|E1|Reported Event|Placebo + MTX|"Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab.~Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
688943|NCT00299104|B4|Baseline|Total|Total of all reporting groups
688944|NCT00299104|B3|Baseline|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688945|NCT00299104|B2|Baseline|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688946|NCT00299104|B1|Baseline|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688947|NCT00299104|P3|Participant Flow|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688948|NCT00299104|P2|Participant Flow|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689101|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
688955|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688956|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688957|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688958|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688959|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688960|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688961|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688962|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688963|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688964|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688965|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688966|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688967|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688968|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688969|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688970|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689003|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689844|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
688971|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688972|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688973|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688974|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688975|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688976|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688977|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688978|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688979|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688980|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688981|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688982|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688983|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688984|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688985|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688986|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689095|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
688987|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688988|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688989|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688990|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688991|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688992|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688993|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688994|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688995|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688996|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688997|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
688998|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
688999|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689000|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689001|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689002|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689096|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689845|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689004|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689005|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689006|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689007|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689008|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689009|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689010|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689011|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689012|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689013|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689014|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689015|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689016|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689017|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689018|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689019|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689097|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689020|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689021|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689022|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689023|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689024|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689025|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689026|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689027|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689028|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689029|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689030|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689031|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689032|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689033|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689034|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689035|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689098|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
689102|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
689846|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689036|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689037|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689038|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689039|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689040|NCT00299104|E3|Reported Event|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689041|NCT00299104|E2|Reported Event|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
689042|NCT00299104|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
689043|NCT00299000|B3|Baseline|Total|Total of all reporting groups
689044|NCT00299000|B2|Baseline|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
689045|NCT00299000|B1|Baseline|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
689046|NCT00299000|P2|Participant Flow|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
689047|NCT00299000|P1|Participant Flow|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
689048|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
689049|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
689050|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
689051|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
689052|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
689053|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
689054|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
689055|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
689056|NCT00299000|E2|Reported Event|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
689057|NCT00299000|E1|Reported Event|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
689058|NCT00298766|B1|Baseline|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689059|NCT00298766|P1|Participant Flow|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689060|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689061|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689062|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689063|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689064|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689065|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689066|NCT00298766|E1|Reported Event|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
689067|NCT00298740|B1|Baseline|Aventis U-400 Insulin|Aventis U-400 Insulin
689068|NCT00298740|P1|Participant Flow|Aventis U-400 Insulin|Aventis U-400 Insulin
689069|NCT00298740|O1|Outcome|Aventis U-400 Insulin|Aventis U-400 Insulin
689070|NCT00298740|E1|Reported Event|Aventis U-400 Insulin|Aventis U-400 Insulin
689099|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689847|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689071|NCT00298610|B1|Baseline|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689072|NCT00298610|P1|Participant Flow|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689073|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689074|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689075|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689076|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689077|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689078|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689079|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689080|NCT00298610|E1|Reported Event|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
689081|NCT00298558|B5|Baseline|Total|Total of all reporting groups
689082|NCT00298558|B4|Baseline|Control|This group did not complete any cognitive training interventions
689083|NCT00298558|B3|Baseline|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689084|NCT00298558|B2|Baseline|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689085|NCT00298558|B1|Baseline|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689086|NCT00298558|P4|Participant Flow|Control|This group did not complete any cognitive training interventions
689087|NCT00298558|P3|Participant Flow|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689088|NCT00298558|P2|Participant Flow|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689089|NCT00298558|P1|Participant Flow|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689090|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
689091|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689092|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689093|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689094|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
689138|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689103|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689104|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689105|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689106|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
689107|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689108|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689109|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689110|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
689111|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689112|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689113|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689114|NCT00298558|E4|Reported Event|Control|This group did not complete any cognitive training interventions
689115|NCT00298558|E3|Reported Event|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
689116|NCT00298558|E2|Reported Event|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
689117|NCT00298558|E1|Reported Event|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
689118|NCT00298363|B4|Baseline|Total|Total of all reporting groups
689119|NCT00298363|B3|Baseline|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689120|NCT00298363|B2|Baseline|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689121|NCT00298363|B1|Baseline|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689122|NCT00298363|P3|Participant Flow|Entecavir|Participants in this group were randomized to receive DB ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
689123|NCT00298363|P2|Participant Flow|FTC/TDF|Participants in this group were randomized to receive DB FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
689124|NCT00298363|P1|Participant Flow|Tenofovir DF|Participants in this group were randomized to receive double-blind (DB) TDF 300 mg + FTC)/TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to open-label (OL) FTC/TDF (this study enrolled participants with decompensated liver disease, and early intervention strategies were provided if profound viral suppression was not achieved quickly).
689125|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689126|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689127|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689128|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689129|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689130|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689131|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689132|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689133|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689134|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689135|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689136|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689137|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689147|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689148|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689149|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689150|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689151|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689152|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689153|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689154|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689155|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689156|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689157|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689158|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689159|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689160|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689161|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689162|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689163|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689164|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689165|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689166|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689167|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689168|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689169|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689170|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689171|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689172|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689173|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689174|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689175|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689176|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689177|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689178|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689179|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689180|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689181|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689182|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689183|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689184|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689185|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689186|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689187|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689188|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689189|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689190|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689191|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689192|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689193|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689194|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689195|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689196|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689197|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689198|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689199|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689200|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689201|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689202|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689203|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689204|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689205|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689206|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689207|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689208|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689209|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689210|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689211|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689212|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689213|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689214|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689215|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689216|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689217|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689218|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689219|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689220|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689221|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689222|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689223|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689224|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689225|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689226|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689227|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689228|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689229|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689230|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689231|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689232|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689233|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689234|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689235|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689236|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689237|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689238|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689239|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689240|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689241|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689242|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689243|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689244|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689245|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689246|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689247|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689248|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689249|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689250|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689251|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689252|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689253|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689254|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689255|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689256|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689257|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689258|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689259|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689260|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689261|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689262|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689263|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689264|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689265|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689266|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
689267|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689268|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689269|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689270|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
689271|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
689272|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
689273|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
689274|NCT00298363|E5|Reported Event|All TDF|Participants in this group received a TDF-containing treatment (all double-blind TDF, FTC/TDF, or open-label FTC/TDF) during the study.
689275|NCT00298363|E4|Reported Event|Open Label FTC/TDF|Participants in this group were randomized to receive TDF, FTC/TDF, or ETV at the beginning of the study, but switched to open label FTC/TDF during the study.
689276|NCT00298363|E3|Reported Event|Double Blind ETV|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo
689277|NCT00298363|E2|Reported Event|Double Blind FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo
689278|NCT00298363|E1|Reported Event|Double Blind TDF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo
689279|NCT00298272|B3|Baseline|Total|Total of all reporting groups
689280|NCT00298272|B2|Baseline|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689469|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689470|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689281|NCT00298272|B1|Baseline|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689282|NCT00298272|P2|Participant Flow|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689283|NCT00298272|P1|Participant Flow|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689284|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689285|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689286|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689287|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689288|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689289|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689290|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689291|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
689292|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689293|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689294|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689471|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
689295|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689296|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689297|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689298|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689299|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689300|NCT00298272|E3|Reported Event|Cumulative Rituximab|The cumulative rituximab treatment group included all participants who received rituximab at any time during the study, including participants who received rituximab in the double-blind period and did not participate in the OL period, those who received placebo in the double-blind period and rituximab in the OL, and those who received rituximab in the double-blind and OL periods. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689301|NCT00298272|E2|Reported Event|Double-Blind Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689302|NCT00298272|E1|Reported Event|Double-Blind Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
689303|NCT00298233|B3|Baseline|Total|Total of all reporting groups
689304|NCT00298233|B2|Baseline|Double Dose Oseltamivir|All participants that were randomized and received doubledose oseltamivir
689305|NCT00298233|B1|Baseline|Standarad Dose Oseltamivir|All participants that were randomized and received standard dose oseltamivir
689306|NCT00298233|P4|Participant Flow|Double Dose Oseltamivir Child Cohort|All Participants <15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
689307|NCT00298233|P3|Participant Flow|Standard Dose Oseltamivir Child Cohort|All participants <15 years received standard dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
689308|NCT00298233|P2|Participant Flow|Double Dose Oseltamivir Adult Cohort|All Participants >= 15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
689309|NCT00298233|P1|Participant Flow|Standard Dose Oseltamivir Adult Cohort|All participants >= 15 years received standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
689310|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
689311|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
689312|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
689313|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
689314|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
689315|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
689316|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
689317|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
689318|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
689319|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
689320|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
689321|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
689322|NCT00298233|E2|Reported Event|Standard Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
689323|NCT00298233|E1|Reported Event|Double Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
689324|NCT00298155|B4|Baseline|Total|Total of all reporting groups
689325|NCT00298155|B3|Baseline|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
689326|NCT00298155|B2|Baseline|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
689327|NCT00298155|B1|Baseline|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
689848|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689328|NCT00298155|P3|Participant Flow|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
689329|NCT00298155|P2|Participant Flow|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
689330|NCT00298155|P1|Participant Flow|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
689331|NCT00298155|O3|Outcome|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
689332|NCT00298155|O2|Outcome|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
689333|NCT00298155|O1|Outcome|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
689334|NCT00298155|O3|Outcome|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
689335|NCT00298155|O2|Outcome|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
689336|NCT00298155|O1|Outcome|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
689337|NCT00298155|E3|Reported Event|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
689338|NCT00298155|E2|Reported Event|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
689339|NCT00298155|E1|Reported Event|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
689340|NCT00298090|B1|Baseline|StO2 Values|StO2 values pre and post arterial line placement.
689341|NCT00298090|P1|Participant Flow|StO2 Values Pre and Post Arterial Line Placement|single arm study of StO2 in subjects undergoing placement of arterial line. Measurements of StO2 will be taken before and after arterial line placement.
689342|NCT00298090|O1|Outcome|StO2 Values|StO2 pre and post catheter placement
689343|NCT00298090|E1|Reported Event|StO2|StO2 measurements pre and post arterial line catheter placement.
689344|NCT00297830|B4|Baseline|Total|Total of all reporting groups
689345|NCT00297830|B3|Baseline|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
689346|NCT00297830|B2|Baseline|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
689347|NCT00297830|B1|Baseline|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
689348|NCT00297830|P3|Participant Flow|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
689349|NCT00297830|P2|Participant Flow|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
689350|NCT00297830|P1|Participant Flow|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
689351|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
689352|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
689353|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
689354|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
689355|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
689472|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice a week for 6 weeks
689849|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689356|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
689357|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
689358|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
689359|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
689360|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
689361|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
689362|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
689363|NCT00297830|E3|Reported Event|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
689364|NCT00297830|E2|Reported Event|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.https://register.clinicaltrials.gov/prs/html/results_definitions.html#Result_ParticipantFlow_Period_title
689365|NCT00297830|E1|Reported Event|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
689366|NCT00297778|B3|Baseline|Total|Total of all reporting groups
689367|NCT00297778|B2|Baseline|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689368|NCT00297778|B1|Baseline|Placebo|Placebo tablet matching active treatment
689369|NCT00297778|P2|Participant Flow|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689370|NCT00297778|P1|Participant Flow|Placebo|Placebo tablet matching active treatment
689371|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689372|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689373|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689374|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689375|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689376|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689377|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689378|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689379|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689380|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689381|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689382|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689383|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689384|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689385|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689386|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689387|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689388|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689389|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689390|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689391|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689392|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689393|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689394|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689395|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689397|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689398|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689399|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689400|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
689401|NCT00297778|E2|Reported Event|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
689402|NCT00297778|E1|Reported Event|Placebo|Placebo tablet matching active treatment
689403|NCT00297648|B1|Baseline|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689404|NCT00297648|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689405|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689406|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689407|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689408|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689409|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689410|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689411|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689412|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689413|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689473|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: True acupuncture twice weekly for 6 weeks
689474|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
689475|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
689850|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689414|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689415|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689416|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689417|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689418|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689419|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689420|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689421|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689422|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689423|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689424|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689425|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689426|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689476|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
689477|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
689478|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689427|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689428|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689429|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689430|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689431|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689432|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689433|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689434|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689435|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689436|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689437|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689438|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689439|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689479|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
689480|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689481|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
689440|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689441|NCT00297648|E1|Reported Event|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
689442|NCT00297596|B1|Baseline|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
689443|NCT00297596|P1|Participant Flow|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
689444|NCT00297596|O1|Outcome|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
689445|NCT00297596|E1|Reported Event|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
689446|NCT00297492|B4|Baseline|Total|Total of all reporting groups
689447|NCT00297492|B3|Baseline|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
689448|NCT00297492|B2|Baseline|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
689449|NCT00297492|B1|Baseline|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
689450|NCT00297492|P3|Participant Flow|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
689451|NCT00297492|P2|Participant Flow|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
689452|NCT00297492|P1|Participant Flow|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
689453|NCT00297492|O3|Outcome|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
689454|NCT00297492|O2|Outcome|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.
689455|NCT00297492|O1|Outcome|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.
689456|NCT00297492|E3|Reported Event|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
689457|NCT00297492|E2|Reported Event|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
689458|NCT00297492|E1|Reported Event|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
689459|NCT00297427|B3|Baseline|Total|Total of all reporting groups
689460|NCT00297427|B2|Baseline|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689461|NCT00297427|B1|Baseline|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689462|NCT00297427|P2|Participant Flow|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689463|NCT00297427|P1|Participant Flow|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689464|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689465|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
689466|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689467|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
689468|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689488|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689489|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689490|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689491|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice weekly for 6 weeks
689492|NCT00297427|O1|Outcome|True Acupuncture|True Acupuncture twice weekly for 6 weeks.
689493|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689494|NCT00297427|O1|Outcome|Acupuncture|Ture acupuncture twice a week for 6 weeks
689495|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689496|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
689497|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689498|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689499|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689500|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689501|NCT00297427|E2|Reported Event|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
689502|NCT00297427|E1|Reported Event|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
689503|NCT00297258|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
689504|NCT00297258|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
689505|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
689506|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689507|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689508|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
689509|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
689510|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689511|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689512|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
689513|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
689514|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689515|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689516|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
689517|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
689518|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689519|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
689520|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
689521|NCT00297258|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
689522|NCT00297232|B1|Baseline|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
689523|NCT00297232|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
689524|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
689525|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
689526|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
689527|NCT00297232|E1|Reported Event|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
689528|NCT00297167|B1|Baseline|Entire Study Population|Includes participants who received EUR-1008 (APT-1008) in open-label dose titration and stabilization phase; and EUR-1008 (APT-1008) first and placebo first after randomization to study treatment.
689529|NCT00297167|P3|Participant Flow|EUR-1008 (APT-1008) (Open-label)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.
689530|NCT00297167|P2|Participant Flow|EUR-1008 (APT-1008) First, Then Placebo|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689544|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689577|NCT00297102|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
689578|NCT00297102|O2|Outcome|Placebo|once daily
689579|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689580|NCT00297102|O2|Outcome|Placebo|once daily
689531|NCT00297167|P1|Participant Flow|Placebo First, Then EUR-1008 (APT-1008)|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day).
689532|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689533|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689534|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689535|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689536|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689537|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689538|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689539|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689540|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689541|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689542|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689543|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689545|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689546|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689547|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689548|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689549|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689550|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689551|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
689552|NCT00297167|E2|Reported Event|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
689553|NCT00297167|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).
689554|NCT00297115|B3|Baseline|Total|Total of all reporting groups
689555|NCT00297115|B2|Baseline|Placebo|once daily
689556|NCT00297115|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
689557|NCT00297115|P2|Participant Flow|Placebo|once daily
689558|NCT00297115|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
689559|NCT00297115|O2|Outcome|Placebo|once daily
689560|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689561|NCT00297115|O2|Outcome|Placebo|once daily
689562|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689563|NCT00297115|O2|Outcome|Placebo|once daily
689564|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689565|NCT00297115|O2|Outcome|Placebo|once daily
689566|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689567|NCT00297115|O2|Outcome|Placebo|once daily
689568|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689569|NCT00297115|O2|Outcome|Placebo|once daily
689570|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689571|NCT00297115|E2|Reported Event|Placebo|once daily
689572|NCT00297115|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
689573|NCT00297102|B3|Baseline|Total|Total of all reporting groups
689574|NCT00297102|B2|Baseline|Placebo|once daily
689575|NCT00297102|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
689581|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689582|NCT00297102|O2|Outcome|Placebo|once daily
689583|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689584|NCT00297102|O2|Outcome|Placebo|once daily
689585|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689586|NCT00297102|O2|Outcome|Placebo|once daily
689587|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689588|NCT00297102|O2|Outcome|Placebo|once daily
689589|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
689590|NCT00297102|E2|Reported Event|Placebo|once daily
689591|NCT00297102|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
689592|NCT00297037|B3|Baseline|Total|Total of all reporting groups
689593|NCT00297037|B2|Baseline|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
689594|NCT00297037|B1|Baseline|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
689595|NCT00297037|P2|Participant Flow|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
689596|NCT00297037|P1|Participant Flow|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
689597|NCT00297037|O2|Outcome|Vehicle|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
689598|NCT00297037|O1|Outcome|Pimecrolimus Cream|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
689599|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
689600|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
689601|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
689602|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
689603|NCT00297037|E2|Reported Event|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
689604|NCT00297037|E1|Reported Event|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
689605|NCT00296816|B3|Baseline|Total|Total of all reporting groups
689606|NCT00296816|B2|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
689607|NCT00296816|B1|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
689608|NCT00296816|P1|Participant Flow|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689609|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689610|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689611|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689727|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689612|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689613|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689614|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689615|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689616|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689617|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689618|NCT00296816|E1|Reported Event|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
689619|NCT00296647|B6|Baseline|Total|Total of all reporting groups
689620|NCT00296647|B5|Baseline|Buproion + Lozenge|
689621|NCT00296647|B4|Baseline|Patch + Lozenge|
689622|NCT00296647|B3|Baseline|Bupropion|
689623|NCT00296647|B2|Baseline|Nicotine Lozenge|
689624|NCT00296647|B1|Baseline|Patch|
689625|NCT00296647|P5|Participant Flow|Buproion + Lozenge|
689626|NCT00296647|P4|Participant Flow|Patch + Lozenge|
689627|NCT00296647|P3|Participant Flow|Bupropion|
689628|NCT00296647|P2|Participant Flow|Nicotine Lozenge|
689629|NCT00296647|P1|Participant Flow|Patch|
689630|NCT00296647|O5|Outcome|Buproion + Lozenge|
689631|NCT00296647|O4|Outcome|Patch + Lozenge|
689632|NCT00296647|O3|Outcome|Bupropion|
689633|NCT00296647|O2|Outcome|Lozenge|
689634|NCT00296647|O1|Outcome|Patch|
689635|NCT00296647|E5|Reported Event|Buproion + Lozenge|
689636|NCT00296647|E4|Reported Event|Patch + Lozenge|
689637|NCT00296647|E3|Reported Event|Bupropion|
689638|NCT00296647|E2|Reported Event|Nicotine Lozenge|
689639|NCT00296647|E1|Reported Event|Patch|
689640|NCT00296517|B3|Baseline|Total|Total of all reporting groups
689641|NCT00296517|B2|Baseline|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689642|NCT00296517|B1|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689643|NCT00296517|P2|Participant Flow|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689644|NCT00296517|P1|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689645|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689646|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689647|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689648|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689649|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689650|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689651|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689652|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689726|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689653|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689654|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689655|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689656|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689657|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689658|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689659|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689660|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689661|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689662|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689663|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689664|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689665|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689666|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689667|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689668|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689669|NCT00296517|E2|Reported Event|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
689670|NCT00296517|E1|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
689671|NCT00296504|B9|Baseline|Total|Total of all reporting groups
689672|NCT00296504|B8|Baseline|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689673|NCT00296504|B7|Baseline|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689674|NCT00296504|B6|Baseline|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689675|NCT00296504|B5|Baseline|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689676|NCT00296504|B4|Baseline|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689677|NCT00296504|B3|Baseline|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689678|NCT00296504|B2|Baseline|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689679|NCT00296504|B1|Baseline|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689680|NCT00296504|P9|Participant Flow|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689681|NCT00296504|P8|Participant Flow|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689682|NCT00296504|P7|Participant Flow|Protease Inhibitor (PI)-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689838|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689683|NCT00296504|P6|Participant Flow|FPV/RTV Twice Daily (BID) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689684|NCT00296504|P5|Participant Flow|FPV/RTV Once Daily (QD) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689685|NCT00296504|P4|Participant Flow|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689686|NCT00296504|P3|Participant Flow|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689687|NCT00296504|P2|Participant Flow|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
689688|NCT00296504|P1|Participant Flow|FPV Population (APV30001)|Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689689|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689690|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689691|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689692|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689693|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689694|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689695|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689696|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689697|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689698|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689699|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689700|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689701|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689702|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689703|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689704|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689705|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689706|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689707|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689708|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689709|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689710|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689711|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689712|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689713|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689714|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689715|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FFPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689716|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689717|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689718|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689719|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689720|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689721|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689722|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689723|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689724|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689725|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689728|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689729|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689730|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689731|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689732|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689733|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689734|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689735|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689736|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689737|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689738|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689739|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689740|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689741|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689742|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689743|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689744|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689745|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689746|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689747|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689748|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689749|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689750|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689751|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689752|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689753|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689754|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689755|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689756|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689757|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689758|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689759|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689760|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689761|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689762|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689763|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689764|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689765|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689766|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689767|NCT00296504|E9|Reported Event|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
689768|NCT00296504|E8|Reported Event|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
689769|NCT00296504|E7|Reported Event|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
689770|NCT00296504|E6|Reported Event|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
689839|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689771|NCT00296504|E5|Reported Event|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
689772|NCT00296504|E4|Reported Event|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
689773|NCT00296504|E3|Reported Event|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
689774|NCT00296504|E2|Reported Event|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
689775|NCT00296504|E1|Reported Event|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
689776|NCT00296491|B5|Baseline|Total|Total of all reporting groups
689777|NCT00296491|B4|Baseline|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
689778|NCT00296491|B3|Baseline|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
689779|NCT00296491|B2|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
689780|NCT00296491|B1|Baseline|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
689781|NCT00296491|P4|Participant Flow|Montelukast (MON)|
689782|NCT00296491|P3|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|
689783|NCT00296491|P2|Participant Flow|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
689784|NCT00296491|P1|Participant Flow|Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Flut Prop = Fluticasone Propionate.
689785|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
689786|NCT00296491|O1|Outcome|Fluticasone Propionate + Salmeterol & Montelukast (FSC+MON)|
689787|NCT00296491|O2|Outcome|Montelukast (MON)|
689788|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
689789|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
689790|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
689791|NCT00296491|O2|Outcome|Montelukast (MON)|
689792|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
689793|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
689794|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
689795|NCT00296491|O2|Outcome|Montelukast (MON)|
689796|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
689797|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
689798|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
689799|NCT00296491|O2|Outcome|Fluticasone Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
689800|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol/Montelukast (FSC+MON)|
689801|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
689802|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Montelukast (FSC+MON)|
689803|NCT00296491|O2|Outcome|Montelukast (MON)|
689804|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol (FSC)|
689805|NCT00296491|E4|Reported Event|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
689806|NCT00296491|E3|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
689807|NCT00296491|E2|Reported Event|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
689808|NCT00296491|E1|Reported Event|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
689809|NCT00296400|B4|Baseline|Total|Total of all reporting groups
689810|NCT00296400|B3|Baseline|Atorvastatin 80 mg|
689811|NCT00296400|B2|Baseline|Rosuvastatin 40 mg|
689812|NCT00296400|B1|Baseline|Rosuvastatin 10 mg|
689813|NCT00296400|P3|Participant Flow|Atorvastatin 80 mg|
689814|NCT00296400|P2|Participant Flow|Rosuvastatin 40 mg|
689815|NCT00296400|P1|Participant Flow|Rosuvastatin 10 mg|
689816|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689817|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689818|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689819|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689820|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689821|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689822|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689823|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689824|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689825|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689826|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689827|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689828|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689829|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689830|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689831|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689832|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689833|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689834|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689835|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689836|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689837|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689851|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689852|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689853|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689854|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689855|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689856|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689857|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689858|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689859|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689860|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689861|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689862|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689863|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689864|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689865|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689866|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689867|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689868|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689869|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689870|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689871|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689872|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689873|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689874|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689875|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689876|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689877|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689878|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689879|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689880|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689881|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689882|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689883|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689884|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689885|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689886|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689887|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689888|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689889|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689890|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689891|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689892|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689893|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689894|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689895|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689896|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689897|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689898|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689899|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689900|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689901|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689902|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689903|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689904|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689905|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689906|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689907|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689908|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689909|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689910|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689911|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689912|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689913|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689914|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689915|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689916|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689917|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689918|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689919|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689920|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689921|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689922|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689923|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689924|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689925|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689926|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689927|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689928|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689929|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689930|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689931|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689932|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689933|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689934|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689935|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689936|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689937|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689938|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689939|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689940|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689941|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689942|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689943|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689944|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689945|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689946|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689947|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689948|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689949|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689950|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689951|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689952|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689953|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689954|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689955|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689956|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689957|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689958|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689959|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689960|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689961|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689962|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689963|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689964|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689965|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689966|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689967|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689968|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689969|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689970|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689971|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689972|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689973|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689974|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689975|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689976|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689977|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689978|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689979|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689980|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689981|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689982|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689983|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689984|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689985|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689986|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689987|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689988|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689989|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689990|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689991|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689992|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689993|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689994|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689995|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689996|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
689997|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
689998|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
689999|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
690000|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690001|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690002|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
690003|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690004|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690005|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
690006|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690007|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690008|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
690009|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690010|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690011|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
690012|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690013|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690014|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
690015|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
690016|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
690017|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
690018|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
690019|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
690020|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
690021|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
690022|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
690023|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
690024|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
690025|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
690026|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
690027|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
690028|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
690029|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
690030|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
690031|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
690032|NCT00296400|E3|Reported Event|Atorvastatin 80 mg|
690033|NCT00296400|E2|Reported Event|Rosuvastatin 40 mg|
690034|NCT00296400|E1|Reported Event|Rosuvastatin 10 mg|
690035|NCT00296374|B4|Baseline|Total|Total of all reporting groups
690036|NCT00296374|B3|Baseline|Atorvastatin 80mg|
690037|NCT00296374|B2|Baseline|Rosuvastatin 40mg|
690038|NCT00296374|B1|Baseline|Rosuvastatin 10mg|
690039|NCT00296374|P3|Participant Flow|Atorvastatin 80mg|
690040|NCT00296374|P2|Participant Flow|Rosuvastatin 40mg|
690041|NCT00296374|P1|Participant Flow|Rosuvastatin 10mg|
690042|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690043|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690044|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690045|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690046|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690047|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690048|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690049|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690050|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690051|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690052|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690053|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690054|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690055|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690056|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690057|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690058|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690059|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690060|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690061|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690062|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690063|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690064|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690065|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690066|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690067|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690068|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690069|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690070|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690071|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690072|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690073|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690074|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690075|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690076|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690077|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690078|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690079|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690080|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690081|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690082|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690083|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690084|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690085|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690086|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690087|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690088|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690089|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690090|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690091|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690092|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690093|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690094|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690095|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690096|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690097|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690098|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690099|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690100|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690101|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690102|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690103|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690104|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690105|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690106|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690107|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690108|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690109|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690110|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690111|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690112|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690113|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690114|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690115|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690116|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690117|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690118|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690119|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690120|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690121|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690122|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690123|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690124|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690125|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690126|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690127|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690128|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690129|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690130|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690131|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690132|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690133|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690134|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690135|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690136|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690137|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690138|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690139|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690140|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690141|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690142|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690143|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690144|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690145|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690146|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690147|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690148|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690149|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690150|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690151|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690152|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690153|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690154|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690155|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690156|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690157|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690158|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690159|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690160|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690161|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690162|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690163|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690164|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690165|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690166|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690167|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690168|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690169|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690170|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690171|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690172|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690173|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690174|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690175|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690176|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690177|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690178|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690179|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690180|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690181|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690182|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690183|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690184|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690185|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690186|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690187|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690188|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690189|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690190|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690191|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690192|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690193|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690194|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690195|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690196|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690197|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690198|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690199|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690200|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690201|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690202|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690203|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690204|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690205|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690206|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690207|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690208|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690209|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690210|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690211|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690212|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690213|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690214|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690215|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690216|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690217|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690218|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690219|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690220|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690221|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690222|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690223|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690224|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690225|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690226|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690227|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690228|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690229|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690230|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690231|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690232|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690233|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690234|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690235|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690236|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690237|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
690238|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
690239|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
690240|NCT00296374|O3|Outcome|Atorvastatin 80 mg|
690241|NCT00296374|O2|Outcome|Rosuvastatin 40 mg|
690242|NCT00296374|O1|Outcome|Rosuvastatin 10 mg|
690243|NCT00296374|O3|Outcome|Atorvastatin 80mg|
690244|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
690245|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
690246|NCT00296374|O3|Outcome|Atorvastatin 80mg|
690247|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
690248|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
690249|NCT00296374|O3|Outcome|Atorvastatin 80mg|
690250|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
690251|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
690252|NCT00296374|O3|Outcome|Atorvastatin 80mg|
690253|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
690254|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
690255|NCT00296374|O3|Outcome|Atorvastatin 80mg|
690256|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
690257|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
690258|NCT00296374|E3|Reported Event|Atorvastatin 80mg|
690259|NCT00296374|E2|Reported Event|Rosuvastatin 40mg|
690260|NCT00296374|E1|Reported Event|Rosuvastatin 10mg|
690261|NCT00296335|B3|Baseline|Total|Total of all reporting groups
690262|NCT00296335|B2|Baseline|Mitomycin, Doxifluridine and Cisplatin|Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
690263|NCT00296335|B1|Baseline|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
690264|NCT00296335|P2|Participant Flow|Mitomycin, Doxifluridine and Cisplatin|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
690265|NCT00296335|P1|Participant Flow|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
690266|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
690267|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
690268|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
690269|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
690270|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
690271|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
690272|NCT00296335|E2|Reported Event|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
690273|NCT00296335|E1|Reported Event|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
690274|NCT00296322|B3|Baseline|Total|Total of all reporting groups
690275|NCT00296322|B2|Baseline|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
690276|NCT00296322|B1|Baseline|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
690277|NCT00296322|P2|Participant Flow|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
690278|NCT00296322|P1|Participant Flow|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
690279|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
690280|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
690281|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
690282|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
690283|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
690284|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
690285|NCT00296322|E2|Reported Event|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
690286|NCT00296322|E1|Reported Event|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
690287|NCT00296296|B3|Baseline|Total|Total of all reporting groups
690288|NCT00296296|B2|Baseline|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690289|NCT00296296|B1|Baseline|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690290|NCT00296296|P2|Participant Flow|Tacrolimus|Patients receive tacrolimus (Prograf; dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690291|NCT00296296|P1|Participant Flow|Cyclosporin|Patients receive cyclosporin (Neoral; dose-adjusted to pre-established targets) as immunosuppressive calcineurin inhibitor (CNI) and Diabetes Education / Management (therapeutic adjustment to target American Diabetes Association (ADA) criteria)
690292|NCT00296296|O2|Outcome|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690293|NCT00296296|O1|Outcome|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690294|NCT00296296|O2|Outcome|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690295|NCT00296296|O1|Outcome|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690296|NCT00296296|O2|Outcome|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690297|NCT00296296|O1|Outcome|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690298|NCT00296296|O2|Outcome|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690299|NCT00296296|O1|Outcome|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690300|NCT00296296|E2|Reported Event|Tacrolimus|Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690301|NCT00296296|E1|Reported Event|Cyclosporin|Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
690302|NCT00296244|B3|Baseline|Total|Total of all reporting groups
690303|NCT00296244|B2|Baseline|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
690304|NCT00296244|B1|Baseline|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
690305|NCT00296244|P2|Participant Flow|Study Group|Study group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)
690306|NCT00296244|P1|Participant Flow|Control Group|Control group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)with steroids
690307|NCT00296244|O2|Outcome|Study Group|Study group - basiliximab, tacrolimus, EC-MPA
690308|NCT00296244|O1|Outcome|Control Group|Control group- basiliximab, tacrolimus, EC-MPA, steroids
690309|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
690310|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
690311|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
690312|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
690313|NCT00296244|O2|Outcome|Study Group|Study group -basiliximab, tacrolimus, EC-MPA
690314|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
690315|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
690316|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
690317|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
690318|NCT00296244|O1|Outcome|Control Group|Control group-basiliximab, tacrolimus, EC-MPA, steroids
690319|NCT00296244|E2|Reported Event|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
690320|NCT00296244|E1|Reported Event|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
691125|NCT00293267|O2|Outcome|Placebo + OBT|
690321|NCT00296231|B1|Baseline|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
690322|NCT00296231|P1|Participant Flow|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
690323|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
690324|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
690325|NCT00296231|E1|Reported Event|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
690326|NCT00296192|B6|Baseline|Total|Total of all reporting groups
690327|NCT00296192|B5|Baseline|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690328|NCT00296192|B4|Baseline|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690329|NCT00296192|B3|Baseline|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690330|NCT00296192|B2|Baseline|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690331|NCT00296192|B1|Baseline|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690332|NCT00296192|P5|Participant Flow|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690333|NCT00296192|P4|Participant Flow|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690334|NCT00296192|P3|Participant Flow|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690335|NCT00296192|P2|Participant Flow|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690336|NCT00296192|P1|Participant Flow|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690337|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690338|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690339|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690340|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690341|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690342|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690343|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690344|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690345|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690346|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690347|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690348|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690349|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690350|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690351|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690352|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690353|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690354|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690355|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690356|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690357|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690358|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690359|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690360|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690361|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690362|NCT00296192|E5|Reported Event|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
690363|NCT00296192|E4|Reported Event|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
690364|NCT00296192|E3|Reported Event|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
690365|NCT00296192|E2|Reported Event|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
690366|NCT00296192|E1|Reported Event|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
690367|NCT00296036|B3|Baseline|Total|Total of all reporting groups
690368|NCT00296036|B2|Baseline|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
690369|NCT00296036|B1|Baseline|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
690370|NCT00296036|P6|Participant Flow|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
690371|NCT00296036|P5|Participant Flow|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
690372|NCT00296036|P4|Participant Flow|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
690373|NCT00296036|P3|Participant Flow|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
690374|NCT00296036|P2|Participant Flow|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
690375|NCT00296036|P1|Participant Flow|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
690376|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
690377|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
690378|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
690379|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
690380|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|"Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.~urea/lactic acid-based topical cream: Applied topically~placebo: Given orally or applied topically"
690381|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
690382|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
690383|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
690384|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II.
690385|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I.
690386|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
690387|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
690388|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
690389|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
690390|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
690391|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
690392|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
690393|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
690394|NCT00296036|O2|Outcome|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily.
690395|NCT00296036|O1|Outcome|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
690396|NCT00296036|O2|Outcome|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily.
690397|NCT00296036|O1|Outcome|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
690398|NCT00296036|E2|Reported Event|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
690399|NCT00296036|E1|Reported Event|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
690400|NCT00295880|B1|Baseline|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690401|NCT00295880|P1|Participant Flow|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690402|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690403|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690404|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690405|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690406|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690407|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690408|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690409|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690410|NCT00295880|E1|Reported Event|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
690411|NCT00295854|B4|Baseline|Total|Total of all reporting groups
690412|NCT00295854|B3|Baseline|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690461|NCT00295750|E3|Reported Event|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690462|NCT00295750|E2|Reported Event|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690413|NCT00295854|B2|Baseline|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690414|NCT00295854|B1|Baseline|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690415|NCT00295854|P3|Participant Flow|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690416|NCT00295854|P2|Participant Flow|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690417|NCT00295854|P1|Participant Flow|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690418|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690419|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690420|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690421|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690422|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690423|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690424|NCT00295854|E3|Reported Event|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690463|NCT00295750|E1|Reported Event|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690464|NCT00295633|B4|Baseline|Total|Total of all reporting groups
690425|NCT00295854|E2|Reported Event|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690426|NCT00295854|E1|Reported Event|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
690427|NCT00295750|B4|Baseline|Total|Total of all reporting groups
690428|NCT00295750|B3|Baseline|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690429|NCT00295750|B2|Baseline|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690430|NCT00295750|B1|Baseline|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690431|NCT00295750|P3|Participant Flow|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690432|NCT00295750|P2|Participant Flow|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690433|NCT00295750|P1|Participant Flow|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690434|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690435|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690436|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690437|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690438|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690439|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690440|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690441|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690442|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690443|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690444|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690445|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690446|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690447|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690448|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690449|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690450|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690451|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690452|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690453|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690454|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690455|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690456|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690457|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690458|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
690459|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
690460|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
690465|NCT00295633|B3|Baseline|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690466|NCT00295633|B2|Baseline|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690467|NCT00295633|B1|Baseline|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690468|NCT00295633|P3|Participant Flow|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690469|NCT00295633|P2|Participant Flow|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690470|NCT00295633|P1|Participant Flow|Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690471|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690472|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690473|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690474|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690475|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690476|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690477|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690478|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690479|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690480|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690481|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690482|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
690483|NCT00295633|E3|Reported Event|SAXA 5MG + TZD|
690484|NCT00295633|E2|Reported Event|SAXA 2.5MG + TZD|
690485|NCT00295633|E1|Reported Event|PLA + TZD|
690486|NCT00295503|B1|Baseline|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks
690487|NCT00295503|P1|Participant Flow|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
690488|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
690489|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
690490|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
690491|NCT00295503|E1|Reported Event|Experimental Arm|cisplatin, pemetrexed, and bevacizumab
690492|NCT00295490|B5|Baseline|Total|Total of all reporting groups
691126|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
690493|NCT00295490|B4|Baseline|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690494|NCT00295490|B3|Baseline|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690495|NCT00295490|B2|Baseline|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690496|NCT00295490|B1|Baseline|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690497|NCT00295490|P4|Participant Flow|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690498|NCT00295490|P3|Participant Flow|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690499|NCT00295490|P2|Participant Flow|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690500|NCT00295490|P1|Participant Flow|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690501|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690502|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690503|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690504|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690505|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690506|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690507|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690508|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690509|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690510|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690511|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690512|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690513|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690514|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690538|NCT00295061|B2|Baseline|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
690515|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690516|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690517|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690518|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690519|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690520|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690521|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690522|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690523|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690524|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690525|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690526|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690527|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690528|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690529|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690530|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690531|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690532|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690533|NCT00295490|E4|Reported Event|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
690534|NCT00295490|E3|Reported Event|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
690535|NCT00295490|E2|Reported Event|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
690536|NCT00295490|E1|Reported Event|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
690537|NCT00295061|B3|Baseline|Total|Total of all reporting groups
693014|NCT00288574|O2|Outcome|Placebo|Placebo
690539|NCT00295061|B1|Baseline|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
690540|NCT00295061|P2|Participant Flow|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
690541|NCT00295061|P1|Participant Flow|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 modified process (MP) (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
690542|NCT00295061|O2|Outcome|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
690543|NCT00295061|O1|Outcome|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
690544|NCT00295061|E2|Reported Event|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
690545|NCT00295061|E1|Reported Event|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
690546|NCT00295009|B7|Baseline|Total|Total of all reporting groups
690547|NCT00295009|B6|Baseline|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
690548|NCT00295009|B5|Baseline|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
690549|NCT00295009|B4|Baseline|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
690550|NCT00295009|B3|Baseline|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690551|NCT00295009|B2|Baseline|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690552|NCT00295009|B1|Baseline|1-Level Fusion|Circumferential fusion at a single lumbar level.
690553|NCT00295009|P6|Participant Flow|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
690554|NCT00295009|P5|Participant Flow|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
690555|NCT00295009|P4|Participant Flow|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
690556|NCT00295009|P3|Participant Flow|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690557|NCT00295009|P2|Participant Flow|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690558|NCT00295009|P1|Participant Flow|1-Level Fusion|Circumferential fusion at a single lumbar level.
690559|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
690560|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
690561|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
690562|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690563|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690564|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
690565|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
690566|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
690567|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
690568|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690569|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690570|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
690571|NCT00295009|E6|Reported Event|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
690572|NCT00295009|E5|Reported Event|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
690573|NCT00295009|E4|Reported Event|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
690574|NCT00295009|E3|Reported Event|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690575|NCT00295009|E2|Reported Event|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
690576|NCT00295009|E1|Reported Event|1-Level Fusion|Circumferential fusion at a single lumbar level.
690577|NCT00294762|B3|Baseline|Total|Total of all reporting groups
690578|NCT00294762|B2|Baseline|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690579|NCT00294762|B1|Baseline|Erlotinib|150 mg erlotinib daily
690580|NCT00294762|P2|Participant Flow|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690581|NCT00294762|P1|Participant Flow|Erlotinib|150 mg erlotinib daily
690582|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690583|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
690584|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690585|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
690586|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690587|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
690588|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690589|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
690590|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690591|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
690592|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690593|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
690594|NCT00294762|E2|Reported Event|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
690595|NCT00294762|E1|Reported Event|Erlotinib|150 mg erlotinib daily
690596|NCT00294723|B4|Baseline|Total|Total of all reporting groups
690597|NCT00294723|B3|Baseline|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690598|NCT00294723|B2|Baseline|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690599|NCT00294723|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690600|NCT00294723|P3|Participant Flow|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690601|NCT00294723|P2|Participant Flow|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690602|NCT00294723|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690603|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690604|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690605|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690606|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690607|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690608|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690609|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690610|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690611|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690612|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690613|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690614|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690615|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690616|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690812|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690617|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690618|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690619|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690620|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690621|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690622|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690623|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690624|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690625|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690626|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690627|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690628|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690629|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690630|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690631|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690632|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690633|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690634|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690635|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690636|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690637|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690638|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690639|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690640|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690641|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690642|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690643|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690644|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690645|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690646|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
693015|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
690647|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690648|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690649|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690650|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690651|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
690652|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
690653|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
690654|NCT00294723|E6|Reported Event|Glimepiride (Weeks 104-195)|Open-label glimepiride 8 mg once daily in the additional extension period (weeks 104-195)
690655|NCT00294723|E5|Reported Event|Lira 1.2 (Weeks 104-195)|Open-label liraglutide 1.2 mg once daily in the additional extension period (weeks 104-195)
690656|NCT00294723|E4|Reported Event|Lira 1.8 (Weeks 104-195)|Open-label liraglutide 1.8 mg once daily in the additional extension period (weeks 104-195)
690657|NCT00294723|E3|Reported Event|Glimepiride (Weeks 0-104)|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension period (weeks 52-104)
690658|NCT00294723|E2|Reported Event|Lira 1.2 (Weeks 0-104)|Liraglutide 1.2 mg once daily + glimepiride placebo 8mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension period (weeks 52-104)
690659|NCT00294723|E1|Reported Event|Lira 1.8 (Weeks 0-104)|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension period (weeks 52-104)
690660|NCT00294684|B3|Baseline|Total|Total of all reporting groups
690661|NCT00294684|B2|Baseline|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690662|NCT00294684|B1|Baseline|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690663|NCT00294684|P2|Participant Flow|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690664|NCT00294684|P1|Participant Flow|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690665|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690666|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690730|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690667|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690668|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690669|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690670|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690671|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690672|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690673|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690674|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690675|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690676|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690731|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690732|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
691176|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
690677|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690678|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690679|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690680|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690681|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690682|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690683|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690684|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690685|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690686|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690733|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690734|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
691177|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
690687|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690688|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690689|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690690|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690691|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690692|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690693|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690694|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690695|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690696|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690735|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690736|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
691178|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
690697|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690698|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690699|NCT00294684|E2|Reported Event|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
690700|NCT00294684|E1|Reported Event|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
690701|NCT00294671|B3|Baseline|Total|Total of all reporting groups
690702|NCT00294671|B2|Baseline|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690703|NCT00294671|B1|Baseline|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690704|NCT00294671|P2|Participant Flow|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690705|NCT00294671|P1|Participant Flow|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690706|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690707|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690708|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690709|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690710|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690711|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690712|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690713|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690714|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690715|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690716|NCT00294671|E2|Reported Event|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
690717|NCT00294671|E1|Reported Event|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
690718|NCT00294658|B3|Baseline|Total|Total of all reporting groups
690719|NCT00294658|B2|Baseline|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690720|NCT00294658|B1|Baseline|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690721|NCT00294658|P2|Participant Flow|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen had been taken every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690722|NCT00294658|P1|Participant Flow|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy had been performed as soon as possible after randomization."
690723|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690724|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690725|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690726|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690727|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690728|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690729|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690737|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690738|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690739|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690740|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690741|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690742|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690743|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690744|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690745|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690746|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690747|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690748|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690749|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690750|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690751|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690752|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690753|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690754|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690755|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690756|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690757|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690758|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690759|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690760|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690761|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690762|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690763|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690764|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690765|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690766|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690767|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690768|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690769|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
693016|NCT00288574|O2|Outcome|Placebo|Placebo group
690770|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690771|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690772|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690773|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690774|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690775|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690776|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690777|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690778|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690779|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690780|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690781|NCT00294658|E2|Reported Event|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
690782|NCT00294658|E1|Reported Event|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
690783|NCT00294645|B3|Baseline|Total|Total of all reporting groups
690784|NCT00294645|B2|Baseline|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690785|NCT00294645|B1|Baseline|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690786|NCT00294645|P2|Participant Flow|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690787|NCT00294645|P1|Participant Flow|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690788|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690789|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690790|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690791|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690792|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690793|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690794|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690795|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690796|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690797|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690798|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690799|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690800|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690801|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690802|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690803|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690804|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690805|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690806|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690807|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690808|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690809|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690810|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690811|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690813|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690814|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690815|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690816|NCT00294645|E2|Reported Event|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
690817|NCT00294645|E1|Reported Event|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
690818|NCT00294554|B3|Baseline|Total|Total of all reporting groups
690819|NCT00294554|B2|Baseline|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690820|NCT00294554|B1|Baseline|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690821|NCT00294554|P2|Participant Flow|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690822|NCT00294554|P1|Participant Flow|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690823|NCT00294554|O2|Outcome|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690824|NCT00294554|O1|Outcome|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690825|NCT00294554|O2|Outcome|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690826|NCT00294554|O1|Outcome|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690827|NCT00294554|E2|Reported Event|Placebo Oral Tablet|"Placebo tablets were formulated to match active 5mg memantine tablets. Dosing same as the active comparator with initiation at 5 mg daily and advancing by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Placebo Oral Tablet: Placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690828|NCT00294554|E1|Reported Event|Active Memantine|"Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of 5 mg to a minimum dose of 5mg/day in the event of intolerance.~Memantine: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed."
690829|NCT00294515|B3|Baseline|Total|Total of all reporting groups
690830|NCT00294515|B2|Baseline|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690831|NCT00294515|B1|Baseline|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690832|NCT00294515|P2|Participant Flow|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690833|NCT00294515|P1|Participant Flow|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690834|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690835|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690836|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690837|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690838|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690839|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690840|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690841|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690842|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690843|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690844|NCT00294515|E2|Reported Event|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
690845|NCT00294515|E1|Reported Event|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
690846|NCT00294398|B3|Baseline|Total|Total of all reporting groups
690847|NCT00294398|B2|Baseline|ICS Prescription + Standard ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
690848|NCT00294398|B1|Baseline|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed.
690849|NCT00294398|P2|Participant Flow|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
690850|NCT00294398|P1|Participant Flow|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.
690851|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
690852|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
690853|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
690854|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
690855|NCT00294398|E2|Reported Event|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
690856|NCT00294398|E1|Reported Event|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
690857|NCT00294060|B1|Baseline|Pacing Patients|Patients implanted with a pacemaker.
690858|NCT00294060|P1|Participant Flow|Pacing Patients|Patients implanted with a pacemaker.
690859|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
690860|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
690861|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
690862|NCT00294060|E1|Reported Event|Pacing Patients|Patients implanted with a pacemaker.
690863|NCT00294047|B3|Baseline|Total|Total of all reporting groups
690864|NCT00294047|B2|Baseline|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690865|NCT00294047|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690866|NCT00294047|P2|Participant Flow|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
691179|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
690867|NCT00294047|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690868|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690869|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690870|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690871|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690872|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690873|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690874|NCT00294047|O2|Outcome|Aluminium Hydroxide|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690875|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690876|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690877|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690878|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690879|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690880|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690881|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690882|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690883|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690884|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690885|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690886|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690887|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690888|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690889|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690890|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690891|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690892|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690893|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690894|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690895|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690896|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690897|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690898|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690899|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690900|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690901|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690902|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690903|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690904|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690905|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690906|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690907|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690908|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690909|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690910|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690911|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690912|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690913|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690914|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690915|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690916|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690917|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690918|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690919|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690920|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690921|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690922|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690923|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690924|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690925|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690926|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690927|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690928|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690929|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690930|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690931|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690932|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690933|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690934|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690935|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690936|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690937|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690938|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690939|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690940|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690941|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690942|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690943|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690944|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690945|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690946|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690947|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690948|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690949|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690950|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690951|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690952|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690953|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690954|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690955|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690956|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690957|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690958|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690959|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690960|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690961|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690962|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690963|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690964|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690965|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690966|NCT00294047|E2|Reported Event|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690967|NCT00294047|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
690968|NCT00293813|B4|Baseline|Total|Total of all reporting groups
690969|NCT00293813|B3|Baseline|Placebo|Placebo
690970|NCT00293813|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
690971|NCT00293813|B1|Baseline|Alendronate 70 mg QW|Alendronate 70 mg QW
690972|NCT00293813|P3|Participant Flow|Placebo|Placebo
690973|NCT00293813|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
690974|NCT00293813|P1|Participant Flow|Alendronate 70 mg QW|Alendronate 70 mg QW
690975|NCT00293813|O3|Outcome|Placebo|Placebo
690976|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
690977|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
690978|NCT00293813|O3|Outcome|Placebo|Placebo
690979|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
690980|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
690981|NCT00293813|E3|Reported Event|Denosumab 60 mg Q6M|
690982|NCT00293813|E2|Reported Event|Alendronate 70 mg QW|
690983|NCT00293813|E1|Reported Event|Placebo|
690984|NCT00293722|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690985|NCT00293722|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690986|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690987|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690988|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690989|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690990|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690991|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690992|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691180|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
690993|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690994|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690995|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690996|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690997|NCT00293722|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690998|NCT00293709|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
690999|NCT00293709|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691000|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691001|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691002|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691003|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691004|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691005|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691006|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691007|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691008|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691009|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691010|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691011|NCT00293709|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
691012|NCT00293579|B1|Baseline|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
691013|NCT00293579|P1|Participant Flow|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
691014|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
691015|NCT00293579|O1|Outcome|Pemetrexed|"pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles~Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles"
691016|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
691017|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
691018|NCT00293579|E1|Reported Event|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
691019|NCT00293540|B3|Baseline|Total|Total of all reporting groups
691020|NCT00293540|B2|Baseline|B Mid-follicular Surgery|
691021|NCT00293540|B1|Baseline|A Mid-luteal Surgery|
691022|NCT00293540|P2|Participant Flow|B Mid-follicular Surgery|
691023|NCT00293540|P1|Participant Flow|A Mid-luteal Surgery|
691024|NCT00293540|O2|Outcome|B Mid-follicular Surgery|
691025|NCT00293540|O1|Outcome|A Mid-luteal Surgery|
691026|NCT00293540|E2|Reported Event|B Mid-follicular Surgery|
691027|NCT00293540|E1|Reported Event|A Mid-luteal Surgery|
691028|NCT00293462|B4|Baseline|Total|Total of all reporting groups
691029|NCT00293462|B3|Baseline|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
691030|NCT00293462|B2|Baseline|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691181|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691031|NCT00293462|B1|Baseline|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691032|NCT00293462|P3|Participant Flow|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691033|NCT00293462|P2|Participant Flow|Arm II: Salt & Soda Group (SS)|Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691034|NCT00293462|P1|Participant Flow|Arm I: GM-CSF Group (GG)|Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691035|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
691036|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691037|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691038|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
691039|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691040|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691041|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
691042|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691043|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691044|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
691045|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691046|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691047|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691048|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691049|NCT00293462|E3|Reported Event|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
691050|NCT00293462|E2|Reported Event|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691051|NCT00293462|E1|Reported Event|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
691052|NCT00293384|B1|Baseline|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
691053|NCT00293384|P1|Participant Flow|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
691077|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691182|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691183|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691054|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
691055|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
691056|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
691057|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
691058|NCT00293384|E1|Reported Event|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
691059|NCT00293293|B3|Baseline|Total|Total of all reporting groups
691060|NCT00293293|B2|Baseline|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691061|NCT00293293|B1|Baseline|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691062|NCT00293293|P2|Participant Flow|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691063|NCT00293293|P1|Participant Flow|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691064|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691065|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691066|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691067|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691068|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691069|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691070|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691071|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691072|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691073|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691074|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691075|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691076|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691078|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691079|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691080|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691081|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691082|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691083|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691084|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691085|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691086|NCT00293293|E2|Reported Event|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
691087|NCT00293293|E1|Reported Event|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
691088|NCT00293267|B3|Baseline|Total|Total of all reporting groups
691089|NCT00293267|B2|Baseline|Placebo + OBT|
691090|NCT00293267|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
691091|NCT00293267|P2|Participant Flow|Placebo + OBT|
691092|NCT00293267|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
691093|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691094|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691095|NCT00293267|O2|Outcome|Placebo + OBT|
691096|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691097|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691098|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691099|NCT00293267|O2|Outcome|Placebo + OBT|
691100|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691101|NCT00293267|O2|Outcome|Placebo + OBT|
691102|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691103|NCT00293267|O2|Outcome|Placebo + OBT|
691104|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691105|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691106|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691107|NCT00293267|O2|Outcome|Placebo + OBT|
691108|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691109|NCT00293267|O2|Outcome|Placebo + OBT|
691110|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691111|NCT00293267|O2|Outcome|Placebo + OBT|
691112|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691113|NCT00293267|O2|Outcome|Placebo + OBT|
691114|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691115|NCT00293267|O2|Outcome|Placebo + OBT|
691116|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691117|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691118|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691119|NCT00293267|O2|Outcome|Placebo + OBT|
691120|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691121|NCT00293267|O2|Outcome|Placebo + OBT|
691122|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691123|NCT00293267|O2|Outcome|Placebo + OBT|
691124|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691127|NCT00293267|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
691128|NCT00293267|E1|Reported Event|Raltegravir 400 mg b.i.d Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
691129|NCT00293254|B3|Baseline|Total|Total of all reporting groups
691130|NCT00293254|B2|Baseline|Placebo + OBT|
691131|NCT00293254|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
691132|NCT00293254|P2|Participant Flow|Placebo + OBT|
691133|NCT00293254|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
691134|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691135|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691136|NCT00293254|O2|Outcome|Placebo + OBT|
691137|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691138|NCT00293254|O2|Outcome|Placebo + OBT|
691139|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691140|NCT00293254|O2|Outcome|Placebo + OBT|
691141|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691142|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691143|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691144|NCT00293254|O2|Outcome|Placebo + OBT|
691145|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691146|NCT00293254|O2|Outcome|Placebo + OBT|
691147|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691148|NCT00293254|O2|Outcome|Placebo + OBT|
691149|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691150|NCT00293254|O2|Outcome|Placebo + OBT|
691151|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691152|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691153|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691154|NCT00293254|O2|Outcome|Placebo + OBT|
691155|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691156|NCT00293254|O2|Outcome|Placebo + OBT|
691157|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691158|NCT00293254|O2|Outcome|Placebo + OBT|
691159|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691160|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
691161|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
691162|NCT00293254|O2|Outcome|Placebo + OBT|
691163|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691164|NCT00293254|O2|Outcome|Placebo + OBT|
691165|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691166|NCT00293254|O2|Outcome|Placebo + OBT|
691167|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
691168|NCT00293254|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
691169|NCT00293254|E1|Reported Event|Raltegravir 400 mg b.i.d. Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
691170|NCT00293241|B3|Baseline|Total|Total of all reporting groups
691171|NCT00293241|B2|Baseline|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691172|NCT00293241|B1|Baseline|MVP ON|Managed Ventricular Pacing programmed on
691173|NCT00293241|P2|Participant Flow|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691174|NCT00293241|P1|Participant Flow|MVP ON|Managed Ventricular Pacing programmed on
691175|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691184|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691185|NCT00293241|O2|Outcome|MVP OFF|"Managed Ventricular Pacing programmed off: conventional pacing~Managed Ventricular Pacing programmed ON/OFF: Device programming"
691186|NCT00293241|O1|Outcome|MVP ON|"Managed Ventricular Pacing programmed on~Managed Ventricular Pacing programmed ON/OFF: Device programming"
691187|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691188|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691189|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691190|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691191|NCT00293241|O2|Outcome|MVP Off|Managed Ventricular Pacing programmed off: conventional pacing
691192|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691193|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691194|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691195|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691196|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691197|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691198|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691199|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691200|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691201|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691202|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691203|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691204|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691205|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691206|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691207|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691208|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691209|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691210|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691211|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691212|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
691213|NCT00293241|E2|Reported Event|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
691214|NCT00293241|E1|Reported Event|MVP ON|Managed Ventricular Pacing programmed on
691215|NCT00293059|B3|Baseline|Total|Total of all reporting groups
691216|NCT00293059|B2|Baseline|Placebo|Matching placebo to be taken orally daily
691217|NCT00293059|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691218|NCT00293059|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
691219|NCT00293059|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691220|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691221|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691222|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691223|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691224|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691225|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691226|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691227|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691228|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691229|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691230|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691231|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691232|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691233|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691234|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691235|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691236|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691237|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691238|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691239|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691240|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691241|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691242|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691243|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691244|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691245|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691246|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691247|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691248|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691249|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691250|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691251|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691252|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691253|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691254|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691255|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691256|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691257|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691258|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691259|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691260|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691261|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691262|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691263|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691264|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691265|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691266|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691267|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691268|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691400|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691269|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691270|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691271|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691272|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691273|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691274|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691275|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691276|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691277|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691278|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691279|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691280|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691281|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691282|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691283|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691284|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691285|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691286|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691287|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691288|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691289|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691290|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691291|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691292|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691293|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691294|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691295|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691296|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691297|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691298|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691299|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691300|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691301|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691302|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691399|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
696437|NCT00279201|E6|Reported Event|Basal Bolus Prior Glargine Addendum|
691303|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691304|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691305|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691306|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691307|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691308|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691309|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691310|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691311|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691312|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691313|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691314|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691315|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691316|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691317|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691318|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691319|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691320|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691321|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691322|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691323|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691324|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691325|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691326|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
691327|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691328|NCT00293059|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
691329|NCT00293059|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
691330|NCT00293020|B1|Baseline|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
691331|NCT00293020|P1|Participant Flow|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
691332|NCT00293020|O1|Outcome|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
691333|NCT00293020|E1|Reported Event|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
691334|NCT00292981|B1|Baseline|C1 Esterase Inhibitor|
691335|NCT00292981|P1|Participant Flow|C1 Esterase Inhibitor|
691336|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
691337|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
691338|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
691339|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
691340|NCT00292981|E1|Reported Event|C1 Esterase Inhibitor|
691341|NCT00292591|B4|Baseline|Total|Total of all reporting groups
691342|NCT00292591|B3|Baseline|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691584|NCT00291694|O1|Outcome|Celecoxib|Randomized to receive celecoxib daily for 12 months
691343|NCT00292591|B2|Baseline|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691344|NCT00292591|B1|Baseline|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691345|NCT00292591|P3|Participant Flow|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691346|NCT00292591|P2|Participant Flow|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691347|NCT00292591|P1|Participant Flow|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691348|NCT00292591|O3|Outcome|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691349|NCT00292591|O2|Outcome|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691350|NCT00292591|O1|Outcome|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691351|NCT00292591|E3|Reported Event|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691352|NCT00292591|E2|Reported Event|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691353|NCT00292591|E1|Reported Event|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
691354|NCT00292461|B3|Baseline|Total|Total of all reporting groups
691355|NCT00292461|B2|Baseline|Lamotrigine|once daily orally for 16 weeks
691356|NCT00292461|B1|Baseline|Zonegran|once or twice daily orally for 16 weeks
691357|NCT00292461|P2|Participant Flow|Lamotrigine|once daily orally for 16 weeks
691358|NCT00292461|P1|Participant Flow|Zonegran|once or twice daily orally for 16 weeks
691359|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
691360|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
691361|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
691362|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
691363|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
691364|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
691365|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
691366|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
691367|NCT00292461|E2|Reported Event|Lamotrigine|once daily orally for 16 weeks
691368|NCT00292461|E1|Reported Event|Zonegran|once or twice daily orally for 16 weeks
691369|NCT00292370|B4|Baseline|Total|Total of all reporting groups
691370|NCT00292370|B3|Baseline|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II: Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine in a double-blind fashion."
691371|NCT00292370|B2|Baseline|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II: Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
691372|NCT00292370|B1|Baseline|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
691373|NCT00292370|P3|Participant Flow|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II : Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine for 8 weeks in a double-blind fashion."
691374|NCT00292370|P2|Participant Flow|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II : Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
691375|NCT00292370|P1|Participant Flow|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
696438|NCT00279201|E5|Reported Event|Basal Bolus Prior Lispro LM Addendum|
691376|NCT00292370|O2|Outcome|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
691377|NCT00292370|O1|Outcome|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
691378|NCT00292370|E3|Reported Event|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
691379|NCT00292370|E2|Reported Event|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
691380|NCT00292370|E1|Reported Event|Arm 1: Open Label (OL) Paroxetine|"In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.~Open Label (OL) Paroxetine: Open-label Paroxetine"
691381|NCT00292318|B3|Baseline|Total|Total of all reporting groups
691382|NCT00292318|B2|Baseline|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
691383|NCT00292318|B1|Baseline|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
691384|NCT00292318|P2|Participant Flow|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
691385|NCT00292318|P1|Participant Flow|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
691386|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
691387|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
691388|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
691389|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
691390|NCT00292318|E2|Reported Event|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
691391|NCT00292318|E1|Reported Event|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
691392|NCT00292227|B3|Baseline|Total|Total of all reporting groups
691393|NCT00292227|B2|Baseline|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691394|NCT00292227|B1|Baseline|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691395|NCT00292227|P3|Participant Flow|Placebo Patch (Infusion: Placebo-Moxifloxacin)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.
691396|NCT00292227|P2|Participant Flow|Placebo Patch (Infusion: Moxifloxacin-Placebo)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.
691397|NCT00292227|P1|Participant Flow|Rotigotine Patch (Infusion: Placebo-Placebo)|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.
691398|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691401|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691402|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691403|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691404|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691405|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691406|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691407|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691408|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691409|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691410|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691411|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691412|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691413|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691414|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691415|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691416|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691417|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691418|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691419|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691420|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691421|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691422|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
691423|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
691424|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691425|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691426|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691427|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691428|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691429|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691430|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691431|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691432|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691433|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691434|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691435|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691436|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691437|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691438|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691439|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691440|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691441|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691442|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691443|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691585|NCT00291694|E2|Reported Event|Placebo|Randomized to receive palcebo daily for 12 months
691444|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691445|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691446|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691447|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691448|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691449|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691450|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691451|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691452|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691453|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691454|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691455|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691456|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691457|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691458|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691459|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691460|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691461|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691462|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691463|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691464|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691465|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691466|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691467|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691468|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691469|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691470|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691471|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691472|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691473|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691474|NCT00292227|E2|Reported Event|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691475|NCT00292227|E1|Reported Event|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
691476|NCT00292188|B3|Baseline|Total|Total of all reporting groups
691477|NCT00292188|B2|Baseline|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691478|NCT00292188|B1|Baseline|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691479|NCT00292188|P3|Participant Flow|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691502|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691586|NCT00291694|E1|Reported Event|Celecoxib|Randomized to receive celecoxib daily for 12 months
691480|NCT00292188|P2|Participant Flow|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691481|NCT00292188|P1|Participant Flow|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
691482|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691483|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691484|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691485|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691486|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691487|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691488|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691489|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691490|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691491|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691492|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691493|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691494|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691495|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691496|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691497|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691498|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691499|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691500|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691501|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691503|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691504|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691505|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691506|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691507|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691508|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691509|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691510|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691511|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691512|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691513|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691514|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691515|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691516|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691517|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691518|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691519|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691520|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691521|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691522|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691523|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691524|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691525|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691526|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691527|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691528|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691529|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691530|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691531|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691532|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691533|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691534|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691535|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691536|NCT00292188|E3|Reported Event|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
691537|NCT00292188|E2|Reported Event|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
691538|NCT00292188|E1|Reported Event|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
691539|NCT00292162|B3|Baseline|Total|Total of all reporting groups
691540|NCT00292162|B2|Baseline|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691541|NCT00292162|B1|Baseline|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691542|NCT00292162|P2|Participant Flow|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691543|NCT00292162|P1|Participant Flow|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691544|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691545|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691546|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691583|NCT00291694|O2|Outcome|Placebo|Randomized to receive placebo daily for 12 months
691547|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691548|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691549|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691550|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691551|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691552|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691553|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691554|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691555|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691556|NCT00292162|E2|Reported Event|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
691557|NCT00292162|E1|Reported Event|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
691558|NCT00291876|B1|Baseline|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691559|NCT00291876|P1|Participant Flow|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691560|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691561|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691562|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691563|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691564|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691565|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691566|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691567|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691568|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691569|NCT00291876|E1|Reported Event|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
691570|NCT00291694|B3|Baseline|Total|Total of all reporting groups
691571|NCT00291694|B2|Baseline|Placebo|Placebo for six months
691572|NCT00291694|B1|Baseline|Celecoxib|Celecoxib for six months
691573|NCT00291694|P2|Participant Flow|Celecoxib|Celecoxib for 12 months
691574|NCT00291694|P1|Participant Flow|Placebo|Placebo for 12 months
691575|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
691576|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
691577|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
691578|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
691579|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
691580|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
691581|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
691582|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
691587|NCT00291655|B1|Baseline|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
691588|NCT00291655|P1|Participant Flow|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
691589|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
691590|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
691591|NCT00291655|E1|Reported Event|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
691592|NCT00291577|B1|Baseline|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691593|NCT00291577|P1|Participant Flow|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691594|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691595|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691596|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691597|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691598|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691599|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691600|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691601|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691602|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691603|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691604|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691605|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691771|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691772|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691606|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691607|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691608|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691609|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691610|NCT00291577|E1|Reported Event|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
691611|NCT00291551|B1|Baseline|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691612|NCT00291551|P1|Participant Flow|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691613|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691614|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691615|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691616|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691617|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691618|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
691619|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
691620|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
691621|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691622|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691623|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691624|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
691625|NCT00291551|E1|Reported Event|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
691626|NCT00291343|B3|Baseline|Total|Total of all reporting groups
691627|NCT00291343|B2|Baseline|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691628|NCT00291343|B1|Baseline|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691629|NCT00291343|P2|Participant Flow|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691773|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691630|NCT00291343|P1|Participant Flow|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691631|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691632|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691633|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691634|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691635|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691636|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691637|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691638|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691639|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691640|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691641|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691642|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691643|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691644|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691645|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
693017|NCT00288574|O1|Outcome|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
691646|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691647|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691648|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691649|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691650|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691651|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691652|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691653|NCT00291343|O2|Outcome|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691654|NCT00291343|O1|Outcome|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691655|NCT00291343|E2|Reported Event|Tritanrix™-HepB/Hiberix™+Mencevax™ ACWY Group|Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691656|NCT00291343|E1|Reported Event|Tritanrix™-HepB/Hib-MenAC +Mencevax™ ACWY Group|Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
691657|NCT00291330|B3|Baseline|Total|Total of all reporting groups
691658|NCT00291330|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
691659|NCT00291330|B1|Baseline|Dabigatran 150 mg|bid (twice daily) oral
691660|NCT00291330|P2|Participant Flow|Warfarin|PRN to maintain an INR of 2.0-3.0
691661|NCT00291330|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
691662|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691663|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691664|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691665|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691666|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691667|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691668|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691669|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691670|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691671|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691672|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691673|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691674|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691675|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691676|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691677|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691678|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
691679|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
691680|NCT00291330|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
691681|NCT00291330|E1|Reported Event|Dabigatran 150 mg|bid (twice daily) oral
693018|NCT00288574|E2|Reported Event|Placebo|Placebo Medication
691682|NCT00291317|B1|Baseline|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
691683|NCT00291317|P1|Participant Flow|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
691684|NCT00291317|O1|Outcome|DEXA|
691685|NCT00291317|O1|Outcome|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
691686|NCT00291317|E1|Reported Event|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
691687|NCT00291226|B3|Baseline|Total|Total of all reporting groups
691688|NCT00291226|B2|Baseline|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
691689|NCT00291226|B1|Baseline|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
691690|NCT00291226|P2|Participant Flow|Placebo Group|Glycine and placebo dosing group.
691691|NCT00291226|P1|Participant Flow|Glycine|Glycine dosing group.
691692|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
691693|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
691774|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691775|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691694|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
691695|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
691696|NCT00291226|E2|Reported Event|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
691697|NCT00291226|E1|Reported Event|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
691698|NCT00291187|B5|Baseline|Total|Total of all reporting groups
691699|NCT00291187|B4|Baseline|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
691700|NCT00291187|B3|Baseline|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
691701|NCT00291187|B2|Baseline|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
691702|NCT00291187|B1|Baseline|Placebo|Taken orally 30 minutes prior to bedtime.
691703|NCT00291187|P4|Participant Flow|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
691704|NCT00291187|P3|Participant Flow|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
691705|NCT00291187|P2|Participant Flow|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
691706|NCT00291187|P1|Participant Flow|Placebo|taken orally 30 minutes prior to bedtime
691707|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
691708|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
691709|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
691710|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime
691711|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
691712|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
691713|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
691714|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
691715|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
691716|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
691717|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
691718|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
691719|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
691720|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
691721|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
691722|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
691723|NCT00291187|E4|Reported Event|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
691724|NCT00291187|E3|Reported Event|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
691725|NCT00291187|E2|Reported Event|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
691726|NCT00291187|E1|Reported Event|Placebo|Taken orally 30 minutes prior to bedtime.
691727|NCT00291161|B5|Baseline|Total|Total of all reporting groups
691728|NCT00291161|B4|Baseline|Caregivers-Usual Care Comparison Group|Caregivers to veterans with diagnosed dementia receiving educational materials and usual care
691729|NCT00291161|B3|Baseline|Caregivers-PDC Group|Caregivers to veterans with diagnosed dementia receiving the PDC Intervention
691730|NCT00291161|B2|Baseline|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
691731|NCT00291161|B1|Baseline|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
691732|NCT00291161|P4|Participant Flow|Caregivers: Usual Care Comparison|Caregivers of the Veterans assigned to the Usual Care Comparison
691733|NCT00291161|P3|Participant Flow|Caregivers: Partners in Dementia Care Intervention|Caregivers for Veterans assigned to the Partners in Dementia Care Intervention
691734|NCT00291161|P2|Participant Flow|Veterans: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
692015|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
691735|NCT00291161|P1|Participant Flow|Veterans: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
691736|NCT00291161|O2|Outcome|Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
691737|NCT00291161|O1|Outcome|Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
691738|NCT00291161|O2|Outcome|Caregivers: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
691739|NCT00291161|O1|Outcome|Caregivers: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
691740|NCT00291161|E2|Reported Event|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
691741|NCT00291161|E1|Reported Event|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
691742|NCT00291135|B1|Baseline|Letrozole|Letrozole, 2.5 mg daily for six months
691743|NCT00291135|P1|Participant Flow|Letrozole|Letrozole, 2.5 mg daily for six months
691744|NCT00291135|O1|Outcome|Letrozole|Letrozole, 2.5 mg daily for six months
691745|NCT00291135|E1|Reported Event|Letrozole|Letrozole, 2.5 mg daily for six months
691746|NCT00291018|B4|Baseline|Total|Total of all reporting groups
691747|NCT00291018|B3|Baseline|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
691748|NCT00291018|B2|Baseline|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized
691749|NCT00291018|B1|Baseline|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized
691750|NCT00291018|P3|Participant Flow|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691751|NCT00291018|P2|Participant Flow|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691752|NCT00291018|P1|Participant Flow|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691753|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691754|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691755|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691756|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691757|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691758|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691759|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691760|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691761|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691762|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691763|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691764|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691765|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691766|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691767|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691768|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691769|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691770|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
693019|NCT00288574|E1|Reported Event|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
691776|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691777|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691778|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691779|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691780|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691781|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691782|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691783|NCT00291018|O3|Outcome|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
691784|NCT00291018|O2|Outcome|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized
691785|NCT00291018|O1|Outcome|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized
691786|NCT00291018|E3|Reported Event|ProDisc-C Continued Access|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
691787|NCT00291018|E2|Reported Event|Control|Anterior Cervical Discectomy and Fusion ACDF Randomized Group
691788|NCT00291018|E1|Reported Event|ProDisc-C|ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
691789|NCT00290888|B3|Baseline|Total|Total of all reporting groups
691790|NCT00290888|B2|Baseline|Arthroscopic Rotator Cuff Repair With Acromioplasty|Arthroscopic rotator cuff repair with acromioplasty (ACR-A)
691791|NCT00290888|B1|Baseline|Arthroscopic Rotator Cuff Repair Without Acromioplasty|Arthroscopic rotator cuff repair without acromioplasty (ACR)
691792|NCT00290888|P2|Participant Flow|Arthorscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
691793|NCT00290888|P1|Participant Flow|Arthroscopic Rotator Cuff Repair Without Acromioplasty|"ACR~Acromioplasty"
691794|NCT00290888|O2|Outcome|Arthorscopic Rotator Cuff Repair With Acromioplasty|ACR-A Acromioplasty
691795|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
691796|NCT00290888|O2|Outcome|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
691797|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
691798|NCT00290888|E2|Reported Event|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
691799|NCT00290888|E1|Reported Event|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
691800|NCT00290810|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
691801|NCT00290810|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
691802|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
691803|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
691804|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
691805|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
691806|NCT00290810|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
691807|NCT00290771|B3|Baseline|Total|Total of all reporting groups
691808|NCT00290771|B2|Baseline|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691809|NCT00290771|B1|Baseline|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691810|NCT00290771|P2|Participant Flow|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691811|NCT00290771|P1|Participant Flow|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691812|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
691813|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691814|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691815|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
691816|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691817|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691818|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
691819|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691820|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691821|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
691822|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691823|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691824|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
691825|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691826|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691827|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
691828|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691829|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691830|NCT00290771|E2|Reported Event|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691831|NCT00290771|E1|Reported Event|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
691832|NCT00290758|B3|Baseline|Total|Total of all reporting groups
691833|NCT00290758|B2|Baseline|Arm B|Patients receive oral placebo once daily for up to 6 months.
691834|NCT00290758|B1|Baseline|Arm A|Patients receive oral genistein once daily for up to 6 months.
691835|NCT00290758|P2|Participant Flow|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
691836|NCT00290758|P1|Participant Flow|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
691837|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
691838|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
691839|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
691840|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
691841|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
691842|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
691843|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
691844|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
691845|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
691846|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
691847|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
691848|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
691849|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
691850|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
691851|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
691852|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
691853|NCT00290758|E2|Reported Event|Arm B (Placebo)|Patients take oral placebo once daily for up to 6 months.
691854|NCT00290758|E1|Reported Event|Arm A (Genistein)|Patients take oral genistein once daily for up to 6 months.
691855|NCT00290732|B3|Baseline|Total|Total of all reporting groups
691856|NCT00290732|B2|Baseline|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
691857|NCT00290732|B1|Baseline|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
691858|NCT00290732|P5|Participant Flow|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
691859|NCT00290732|P4|Participant Flow|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
691860|NCT00290732|P3|Participant Flow|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
691861|NCT00290732|P2|Participant Flow|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
691862|NCT00290732|P1|Participant Flow|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
691863|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
691864|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
693020|NCT00288509|B1|Baseline|Dysport|250-1000 units
691865|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
691866|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
691867|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
691868|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
691869|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
691870|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
691871|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
691872|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
691873|NCT00290732|O1|Outcome|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
691874|NCT00290732|E5|Reported Event|Intravenous Arm|Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.
691875|NCT00290732|E4|Reported Event|Intraductal Arm- 10 mg PLD|
691876|NCT00290732|E3|Reported Event|Intraductal Arm- 5 mg PLD|
691877|NCT00290732|E2|Reported Event|Intraductal Arm- 2 mg PLD|
691878|NCT00290732|E1|Reported Event|Intraductal Arm- 0 mg PLD|
691879|NCT00290693|B1|Baseline|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691880|NCT00290693|P1|Participant Flow|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691881|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691882|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691883|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691884|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691885|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691886|NCT00290693|E1|Reported Event|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
691887|NCT00290654|B1|Baseline|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
691888|NCT00290654|P1|Participant Flow|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
691889|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691890|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691891|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691892|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691893|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691894|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691895|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691896|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
691897|NCT00290654|E1|Reported Event|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
692016|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
691898|NCT00290615|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
691899|NCT00290615|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
691900|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
691901|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
691902|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
691903|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
691904|NCT00290615|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
691905|NCT00290537|B1|Baseline|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
691906|NCT00290537|P2|Participant Flow|Part Two: ZD6474 + Carboplatin + Paclitaxel|Second part of two part treatment, Part One /Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks.
691907|NCT00290537|P1|Participant Flow|Part One: ZD6474|First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks
691908|NCT00290537|O2|Outcome|ZD6474 + Carboplatin + Paclitaxel|Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
691909|NCT00290537|O1|Outcome|ZD6474|First part of treatment: three 3-week cycles 300 mg of ZD6474 daily. Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
691910|NCT00290537|E1|Reported Event|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
691911|NCT00290472|B4|Baseline|Total|Total of all reporting groups
691912|NCT00290472|B3|Baseline|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
691913|NCT00290472|B2|Baseline|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
691914|NCT00290472|B1|Baseline|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
691915|NCT00290472|P3|Participant Flow|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
691916|NCT00290472|P2|Participant Flow|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
691917|NCT00290472|P1|Participant Flow|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
692017|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
691918|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
691919|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
691920|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
691921|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
691922|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
691923|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
691924|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
691925|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
691926|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
691927|NCT00290472|E1|Reported Event|Temsirolimus|All patients
691928|NCT00290407|B1|Baseline|RITUXIMAB PLUS ORAL Β-GLUCAN|
691929|NCT00290407|P1|Participant Flow|RITUXIMAB PLUS ORAL Β-GLUCAN|
691930|NCT00290407|O1|Outcome|RITUXIMAB PLUS ORAL Β-GLUCAN|
691931|NCT00290407|O1|Outcome|RITUXIMAB PLUS ORAL Β-GLUCAN|
691932|NCT00290407|E1|Reported Event|RITUXIMAB PLUS ORAL Β-GLUCAN|
691933|NCT00290329|B4|Baseline|Total|Total of all reporting groups
691934|NCT00290329|B3|Baseline|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691935|NCT00290329|B2|Baseline|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691936|NCT00290329|B1|Baseline|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691937|NCT00290329|P3|Participant Flow|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691938|NCT00290329|P2|Participant Flow|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691939|NCT00290329|P1|Participant Flow|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691940|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691941|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691942|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691943|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691944|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
692084|NCT00289978|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
691945|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691946|NCT00290329|O2|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691947|NCT00290329|O1|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691948|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691949|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691950|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691951|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691952|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691953|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691954|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691955|NCT00290329|E3|Reported Event|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691956|NCT00290329|E2|Reported Event|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691957|NCT00290329|E1|Reported Event|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
691958|NCT00290290|B3|Baseline|Total|Total of all reporting groups
691959|NCT00290290|B2|Baseline|Chlorhexidine-alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
691960|NCT00290290|B1|Baseline|Povidone-iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
691961|NCT00290290|P2|Participant Flow|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
691962|NCT00290290|P1|Participant Flow|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
691963|NCT00290290|O2|Outcome|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
691964|NCT00290290|O1|Outcome|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
691965|NCT00290290|E2|Reported Event|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
691966|NCT00290290|E1|Reported Event|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
691967|NCT00290251|B1|Baseline|Eligible Women|All women who consented and were eligible
691968|NCT00290251|P3|Participant Flow|Placebo (PLC)|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
691969|NCT00290251|P2|Participant Flow|Ulipristal Acetate- 10 mg|Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
691970|NCT00290251|P1|Participant Flow|Ulipristal Acetate - 20 mg|Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
691971|NCT00290251|O2|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
691972|NCT00290251|O1|Outcome|Ulipristal Acetate -10 and 20mg|Women received ulipristal acetate at a daily dose of 10 or 20 mg for 90 - 102 days or three menstrual cycles.
691973|NCT00290251|O3|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
691974|NCT00290251|O2|Outcome|Ulipristal Acetate - 10 mg|Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.
691975|NCT00290251|O1|Outcome|Ulipristal Acetate -20mg|Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.
691976|NCT00290251|E3|Reported Event|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
691977|NCT00290251|E2|Reported Event|CDB-2914 - 10 mg|Women received CDB-2914 at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
691978|NCT00290251|E1|Reported Event|CDB-2914 -20mg|Women received CDB-2914 at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
691979|NCT00290238|B3|Baseline|Total|Total of all reporting groups
691980|NCT00290238|B2|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
692018|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
693021|NCT00288509|P1|Participant Flow|Dysport|250-1000 units
691981|NCT00290238|B1|Baseline|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
691982|NCT00290238|P2|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
691983|NCT00290238|P1|Participant Flow|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
691984|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
691985|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
691986|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
691987|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
691988|NCT00290238|E2|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
691989|NCT00290238|E1|Reported Event|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
691990|NCT00290199|B3|Baseline|Total|Total of all reporting groups
691991|NCT00290199|B2|Baseline|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691992|NCT00290199|B1|Baseline|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691993|NCT00290199|P2|Participant Flow|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691994|NCT00290199|P1|Participant Flow|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691995|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691996|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691997|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691998|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
691999|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
692000|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
692001|NCT00290199|O2|Outcome|No Foley|No transcervical foley catheter inserted to induce labor
692002|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a a transcervical foley catheter to induce labor
692003|NCT00290199|E2|Reported Event|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
692004|NCT00290199|E1|Reported Event|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
692005|NCT00290186|B3|Baseline|Total|Total of all reporting groups
692006|NCT00290186|B2|Baseline|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692007|NCT00290186|B1|Baseline|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692008|NCT00290186|P2|Participant Flow|Hyperbaric Air Treatment (HBA)|"Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~24 Were allocated to HBA 22 Completed all 40 treatments~1 Withdrew prior to treatments~1 Withdrawn during treatments for seizures due to shunt malfunction 22 Completed post treatment testing~1 Study terminated prior to 3-month followup testing 21 Completed 3-month followup testing~1 Did not return for 6-month followup testing~1 Missed 6-month followup testing due to illness not related to study 19 Completed 6-month followup testing 22 Included in pre and post treatment analyses 21 Included in pre, post, and 3-month analyses 19 Included in pre, post, 3-month and 6-month analyses"
692009|NCT00290186|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBO)|"Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~25 Were allocated to HBO 24 Completed all 40 treatments~1 Withdrawn during treatments due to right ear problems and rectal bleeding 24 Completed post treatment testing~Study terminated prior to 3-month followup testing~Did not return for 3- or 6-month followup testing~1 Missed 3-month followup due to illness not related to study but returned for 6-month followup testing 20 Completed 3-month followup testing 20 Completed 6-month testing 24 Included in pre and post treatment analyses 20 Included in pre, post, and 3-month analyses 20 Included in pre, post, 3-month and 6-month analyses"
692010|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692011|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692012|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692013|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692014|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692019|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692020|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692021|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692022|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692023|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692024|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692025|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692026|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692027|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692028|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692029|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692030|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692031|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692032|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692033|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692034|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692035|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692036|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692037|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692038|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692039|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692040|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|"14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
692041|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|"100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
692042|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692043|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692044|NCT00290186|E2|Reported Event|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692045|NCT00290186|E1|Reported Event|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
692046|NCT00290147|B3|Baseline|Total|Total of all reporting groups
692047|NCT00290147|B2|Baseline|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692048|NCT00290147|B1|Baseline|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692049|NCT00290147|P2|Participant Flow|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692050|NCT00290147|P1|Participant Flow|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692051|NCT00290147|O2|Outcome|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692052|NCT00290147|O1|Outcome|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692053|NCT00290147|O2|Outcome|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692054|NCT00290147|O1|Outcome|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692055|NCT00290147|E2|Reported Event|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692056|NCT00290147|E1|Reported Event|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
692057|NCT00289991|B3|Baseline|Total|Total of all reporting groups
693022|NCT00288509|O1|Outcome|Dysport|250-1000 units
692058|NCT00289991|B2|Baseline|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692059|NCT00289991|B1|Baseline|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692060|NCT00289991|P2|Participant Flow|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692061|NCT00289991|P1|Participant Flow|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).
692062|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692063|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692064|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692065|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692066|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692067|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692068|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692069|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692070|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692071|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692072|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692073|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692074|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692075|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692076|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692077|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692078|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692079|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692080|NCT00289991|E2|Reported Event|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
692081|NCT00289991|E1|Reported Event|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
692082|NCT00289978|B4|Baseline|Total|Total of all reporting groups
692083|NCT00289978|B3|Baseline|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
693023|NCT00288509|O1|Outcome|Dysport|250-1000 units
692085|NCT00289978|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
692086|NCT00289978|P3|Participant Flow|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
692087|NCT00289978|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
692088|NCT00289978|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
692089|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
692090|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
692091|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
692092|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
692093|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
692094|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
692095|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
692096|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
692097|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
692098|NCT00289978|E3|Reported Event|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
692099|NCT00289978|E2|Reported Event|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
692100|NCT00289978|E1|Reported Event|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
692101|NCT00289913|B6|Baseline|Total|Total of all reporting groups
692102|NCT00289913|B5|Baseline|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
692103|NCT00289913|B4|Baseline|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692104|NCT00289913|B3|Baseline|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692105|NCT00289913|B2|Baseline|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692106|NCT00289913|B1|Baseline|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692107|NCT00289913|P5|Participant Flow|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
692108|NCT00289913|P4|Participant Flow|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692109|NCT00289913|P3|Participant Flow|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692110|NCT00289913|P2|Participant Flow|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692111|NCT00289913|P1|Participant Flow|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692112|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
692113|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692114|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692115|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692116|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692117|NCT00289913|O3|Outcome|VAQTA™/VAQTA™|All participants receiving VAQTA™ alone (from Stage II) on Day 1 and Day 24.
692118|NCT00289913|O2|Outcome|Non-concomitant VAQTA™ Separate From Infanrix™ and PedvaxHIB™|All participants receiving VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 2: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1); and Group 4: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1).
692119|NCT00289913|O1|Outcome|Concomitant VAQTA™ With Infanrix™ and PedvaxHIB™ or PedvaxHIB™|All participants receiving VAQTA™ Concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 1: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1); and Group 3: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1).
692120|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
692121|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
693024|NCT00288509|O1|Outcome|Dysport|250-1000 units
692122|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692123|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692124|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692125|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
692126|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692127|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692128|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692129|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692130|NCT00289913|E5|Reported Event|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
692131|NCT00289913|E4|Reported Event|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692132|NCT00289913|E3|Reported Event|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692133|NCT00289913|E2|Reported Event|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
692134|NCT00289913|E1|Reported Event|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
692135|NCT00289900|B7|Baseline|Total|Total of all reporting groups
692136|NCT00289900|B6|Baseline|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692137|NCT00289900|B5|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692138|NCT00289900|B4|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692139|NCT00289900|B3|Baseline|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692140|NCT00289900|B2|Baseline|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692141|NCT00289900|B1|Baseline|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692142|NCT00289900|P6|Participant Flow|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692143|NCT00289900|P5|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692144|NCT00289900|P4|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692145|NCT00289900|P3|Participant Flow|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692146|NCT00289900|P2|Participant Flow|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692147|NCT00289900|P1|Participant Flow|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692148|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692149|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692150|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692151|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692152|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692153|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692154|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692155|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692156|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692157|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692158|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692570|NCT00289536|E1|Reported Event|Safety Population (26 Participants)|Participants who received at least 1 infusion of rAHF-PFM
692159|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692160|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692161|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692162|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692163|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692164|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692165|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692166|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692167|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692168|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692169|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692170|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692171|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692172|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692173|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692174|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
692175|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
692176|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692177|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692178|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692179|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692180|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692181|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692182|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692183|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692184|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692185|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692186|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692187|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692188|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692189|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692190|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692191|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692192|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692193|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692194|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692195|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692196|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692197|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692198|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692199|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692200|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692201|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692202|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692203|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692668|NCT00289211|E2|Reported Event|Placebo|
692204|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692205|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692206|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692207|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692208|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692209|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692210|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692211|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692212|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692213|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692214|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692215|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692216|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692217|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692218|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692219|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692220|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692221|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692222|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692223|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692224|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692225|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692226|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692227|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692228|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692229|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692230|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692231|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692232|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692233|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692234|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692235|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692236|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692237|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692238|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692239|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692240|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692241|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692242|NCT00289900|E6|Reported Event|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
692243|NCT00289900|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
692244|NCT00289900|E4|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
692245|NCT00289900|E3|Reported Event|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
692246|NCT00289900|E2|Reported Event|MK-0524B 2g/40 mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
692511|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
692247|NCT00289900|E1|Reported Event|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
692248|NCT00289887|B3|Baseline|Total|Total of all reporting groups
692249|NCT00289887|B2|Baseline|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692250|NCT00289887|B1|Baseline|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692251|NCT00289887|P2|Participant Flow|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692252|NCT00289887|P1|Participant Flow|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692253|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692254|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692255|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692256|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692257|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692258|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692259|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692260|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692261|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692262|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692263|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692264|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692265|NCT00289887|E2|Reported Event|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
692266|NCT00289887|E1|Reported Event|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
692267|NCT00289874|B3|Baseline|Total|Total of all reporting groups
692268|NCT00289874|B2|Baseline|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
692269|NCT00289874|B1|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
692270|NCT00289874|P2|Participant Flow|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
692271|NCT00289874|P1|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
692272|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
692273|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
692274|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
692275|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
692276|NCT00289874|E2|Reported Event|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
692277|NCT00289874|E1|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
692278|NCT00289848|B3|Baseline|Total|Total of all reporting groups
692279|NCT00289848|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
692280|NCT00289848|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
692281|NCT00289848|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
692282|NCT00289848|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
692283|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
692284|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
692285|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
692286|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
692287|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
692288|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
692289|NCT00289848|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
692290|NCT00289848|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
692291|NCT00289783|B3|Baseline|Total|Total of all reporting groups
692292|NCT00289783|B2|Baseline|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692293|NCT00289783|B1|Baseline|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692294|NCT00289783|P2|Participant Flow|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692295|NCT00289783|P1|Participant Flow|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692296|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692297|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692298|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692299|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692300|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692301|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692302|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692565|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692303|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692304|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692305|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692306|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692307|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692308|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692309|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692310|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692311|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692312|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692313|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692314|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692315|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692473|NCT00289770|P1|Participant Flow|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692316|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692317|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692318|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692319|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692320|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692321|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692322|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692323|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692324|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692325|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692326|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692327|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692328|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692474|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692566|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692329|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692330|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692331|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692332|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692333|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692334|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692335|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692336|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692337|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692338|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692339|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692340|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692341|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692475|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692342|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692343|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692344|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692345|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692346|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692347|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692348|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692349|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692350|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692351|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692352|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692353|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692354|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692476|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692567|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692355|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692356|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692357|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692358|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692359|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692360|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692361|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692362|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692363|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692364|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692365|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692366|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692367|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692477|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692368|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692369|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692370|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692371|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692372|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692373|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692374|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692375|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692376|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692377|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692378|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692379|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692380|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692478|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692381|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692382|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692383|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692384|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692385|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692386|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692387|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692388|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692389|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692390|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692391|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692392|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692393|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692479|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692394|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692395|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692396|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692397|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692398|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692399|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692400|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692401|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692402|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692403|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692404|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692405|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692406|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692480|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692407|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692408|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692409|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692410|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692411|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692412|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692413|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692414|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692415|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692416|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692417|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692418|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692419|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692481|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692420|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692421|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692422|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692423|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692424|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692425|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692426|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692427|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692428|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692429|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692430|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692431|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692432|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692482|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692568|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692433|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692434|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692435|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692436|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692437|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692438|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692439|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692440|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692441|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692442|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692443|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692444|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692445|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692483|NCT00289770|E1|Reported Event|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692446|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692447|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692448|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692449|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692450|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692451|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692452|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692453|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692454|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692455|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692456|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692457|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692458|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692510|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
692459|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692460|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692461|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692462|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692463|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692464|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692465|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692466|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692467|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692468|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692469|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692470|NCT00289783|E2|Reported Event|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692471|NCT00289783|E1|Reported Event|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
692472|NCT00289770|B1|Baseline|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
692484|NCT00289757|B1|Baseline|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692485|NCT00289757|P1|Participant Flow|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692486|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692487|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692488|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692489|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692490|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692491|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692492|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692493|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692494|NCT00289757|E1|Reported Event|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
692495|NCT00289744|B1|Baseline|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
692496|NCT00289744|P3|Participant Flow|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
692497|NCT00289744|P2|Participant Flow|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
692498|NCT00289744|P1|Participant Flow|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
692499|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
692500|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
692501|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
692502|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
692503|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
692504|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
692505|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
692506|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
692507|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
692508|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
692509|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
692569|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692512|NCT00289744|E3|Reported Event|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
692513|NCT00289744|E2|Reported Event|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
692514|NCT00289744|E1|Reported Event|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
692515|NCT00289718|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
692516|NCT00289718|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
692517|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
692518|NCT00289718|O1|Outcome|Twinrix Group|Subjects who received 2 doses of Twinrix™ (lot A) in the primary study.
692519|NCT00289718|O1|Outcome|Twinrix Group|Subjects who received 2 doses of Twinrix™ (lot A) in the primary study.
692520|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
692521|NCT00289718|O2|Outcome|Twinrix Group (Lot B)|Subjects who received 2 doses of Twinrix™ (lot B) in the primary study.
692522|NCT00289718|O1|Outcome|Twinrix Group (Lot A)|Subjects who received 2 doses of Twinrix™ (lot A) in the primary study.
692523|NCT00289718|O1|Outcome|TWINRIX GROUP|Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up
692524|NCT00289718|O1|Outcome|TWINRIX GROUP|Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up
692525|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
692526|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
692527|NCT00289718|O1|Outcome|Twinrix Group|Subjects who received 2 doses of Twinrix™ (lot A) in the primary study.
692528|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups~(lot A, B or C) were pooled into the Twinrix Group for data analyses during~the long term follow-up"
692529|NCT00289718|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
692530|NCT00289536|B1|Baseline|Treated Participants|Participants who received at least 1 infusion of rAHF-PFM.
692531|NCT00289536|P3|Participant Flow|High Dose|50 IU/kg rAHF-PFM
692532|NCT00289536|P2|Participant Flow|Medium Dose|30 IU/kg rAHF-PFM
692533|NCT00289536|P1|Participant Flow|Low Dose|15 IU/kg rAHF-PFM
692534|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692535|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692536|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692537|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692538|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692539|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692540|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692541|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692542|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692543|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692544|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692545|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692546|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692547|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692548|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692549|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692550|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692551|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692552|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692553|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692554|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692555|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692556|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692557|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692558|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692559|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692560|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692561|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692562|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
692563|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
692564|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
692571|NCT00289471|B1|Baseline|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
692572|NCT00289471|P1|Participant Flow|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
692573|NCT00289471|O1|Outcome|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
692574|NCT00289471|E1|Reported Event|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
692575|NCT00289458|B4|Baseline|Total|Total of all reporting groups
692576|NCT00289458|B3|Baseline|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692577|NCT00289458|B2|Baseline|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692578|NCT00289458|B1|Baseline|Control Group|Continued with usual activity and care, no intervention
692579|NCT00289458|P3|Participant Flow|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692580|NCT00289458|P2|Participant Flow|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692581|NCT00289458|P1|Participant Flow|Control Group|Continued with usual activity and care, no intervention
692582|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692583|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692584|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
692585|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692586|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692587|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
692588|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692589|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692590|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
692591|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692592|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692593|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
692594|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692595|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692596|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
692597|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692598|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692599|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
692600|NCT00289458|E3|Reported Event|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
692601|NCT00289458|E2|Reported Event|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
692602|NCT00289458|E1|Reported Event|Control Group|Continued with usual activity and care, no intervention
692603|NCT00289341|B3|Baseline|Total|Total of all reporting groups
692604|NCT00289341|B2|Baseline|Placebo|
692605|NCT00289341|B1|Baseline|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
692606|NCT00289341|P2|Participant Flow|Placebo|
692607|NCT00289341|P1|Participant Flow|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
692608|NCT00289341|O1|Outcome|Pre-vs Post-vaccination PSA Slope|
692609|NCT00289341|O1|Outcome|Median Difference, Post-Pre Vaccination|For each antigen group, the difference between the post and pre-vaccination T cell proliferation response was calculated.
692610|NCT00289341|O2|Outcome|Placebo|12 patients receiving vehicle only
692669|NCT00289211|E1|Reported Event|C1INH-nf|
692670|NCT00289198|B3|Baseline|Total|Total of all reporting groups
693025|NCT00288509|O1|Outcome|Dysport|250-1000 units
692611|NCT00289341|O1|Outcome|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
692612|NCT00289341|E4|Reported Event|Arm 1 and 2 Post-Vaccination Phase|unblinded
692613|NCT00289341|E3|Reported Event|Arm 2 Vaccine Phase|Unblinded
692614|NCT00289341|E2|Reported Event|Arm 1 Vaccine Phase|Single blind
692615|NCT00289341|E1|Reported Event|Arm 2 Placebo Phase|Single-blind
692616|NCT00289289|B4|Baseline|Total|Total of all reporting groups
692617|NCT00289289|B3|Baseline|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
692618|NCT00289289|B2|Baseline|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
692619|NCT00289289|B1|Baseline|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
692620|NCT00289289|P3|Participant Flow|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
692621|NCT00289289|P2|Participant Flow|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
692622|NCT00289289|P1|Participant Flow|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
692623|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
692624|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
692625|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
692626|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
692627|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
692628|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
692629|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
692630|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
692631|NCT00289289|E3|Reported Event|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
692632|NCT00289289|E2|Reported Event|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
692633|NCT00289289|E1|Reported Event|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
692634|NCT00289276|B3|Baseline|Total|Total of all reporting groups
692635|NCT00289276|B2|Baseline|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
692636|NCT00289276|B1|Baseline|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
692637|NCT00289276|P2|Participant Flow|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
692638|NCT00289276|P1|Participant Flow|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
692639|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
692796|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
692640|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
692641|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
692642|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
692643|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
692644|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
692645|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
692646|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
692647|NCT00289276|E2|Reported Event|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
692648|NCT00289276|E1|Reported Event|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
692649|NCT00289211|B4|Baseline|Total|Total of all reporting groups
692650|NCT00289211|B3|Baseline|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
692651|NCT00289211|B2|Baseline|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692652|NCT00289211|B1|Baseline|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692653|NCT00289211|P3|Participant Flow|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
692654|NCT00289211|P2|Participant Flow|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692655|NCT00289211|P1|Participant Flow|C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692656|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692657|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692658|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692659|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692660|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692661|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692662|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692663|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692664|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692665|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692666|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
692667|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
692671|NCT00289198|B2|Baseline|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692672|NCT00289198|B1|Baseline|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692673|NCT00289198|P2|Participant Flow|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray (27.5 mcg per spray) into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692674|NCT00289198|P1|Participant Flow|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692675|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692676|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692677|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692678|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692679|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692680|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692681|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692682|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692683|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692684|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692685|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692686|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692687|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692688|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692797|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
692798|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
692689|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692690|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692691|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692692|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692693|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692694|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692695|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692696|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692697|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692698|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692699|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692700|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692701|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692702|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692703|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692704|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692705|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692706|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692799|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
692800|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
692707|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692708|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692709|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692710|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692711|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692712|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692713|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692714|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692715|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692716|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692717|NCT00289198|O2|Outcome|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692718|NCT00289198|O1|Outcome|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692719|NCT00289198|E2|Reported Event|Fluticasone Furoate|Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692720|NCT00289198|E1|Reported Event|Placebo|Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
692721|NCT00289185|B3|Baseline|Total|Total of all reporting groups
692722|NCT00289185|B2|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692723|NCT00289185|B1|Baseline|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692724|NCT00289185|P2|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692725|NCT00289185|P1|Participant Flow|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
693026|NCT00288509|E1|Reported Event|Dysport|250-1000 units
692726|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692727|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692728|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692729|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692730|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692731|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692732|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692733|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692734|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692735|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692736|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692737|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692738|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692739|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692740|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692741|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692742|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
693027|NCT00288080|B3|Baseline|Total|Total of all reporting groups
692743|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692744|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692745|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692746|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692747|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692748|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692749|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692750|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692751|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692752|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692753|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692754|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692755|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692756|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692757|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692758|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692759|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
694161|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
692760|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692761|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
692762|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692763|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692764|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692765|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692766|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692767|NCT00289185|E2|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
692768|NCT00289185|E1|Reported Event|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
692769|NCT00289133|B3|Baseline|Total|Total of all reporting groups
692770|NCT00289133|B2|Baseline|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
692771|NCT00289133|B1|Baseline|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
692772|NCT00289133|P2|Participant Flow|XLK Poly|Cross-linked polyethylene tibial component
692773|NCT00289133|P1|Participant Flow|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
692774|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
692775|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
692776|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
692777|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
692778|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
692779|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
692780|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
692781|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
692782|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
692783|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
692784|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
692785|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
692786|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene tibial component
692787|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
692788|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
692789|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
692790|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
692791|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
692792|NCT00289133|E2|Reported Event|XLK Poly|Cross-linked polyethylene tibial component
692793|NCT00289133|E1|Reported Event|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
692794|NCT00289120|B1|Baseline|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a 3-week wash out period before subjects enter phase 2 of the study.~Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
692795|NCT00289120|P1|Participant Flow|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks wash-out period before patients entere phase 2 of thre study.~Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
694218|NCT00285467|B3|Baseline|Total|Total of all reporting groups
692801|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
692802|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
692803|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
692804|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
692805|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
692806|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
692807|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
692808|NCT00289120|E2|Reported Event|Deionized Water Drinking Phase|"Subjects were given 500cc of regular deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~No adverse event reported."
692809|NCT00289120|E1|Reported Event|Cola Beverage Phase|"Subjects were given 500cc of Cola twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks interval (wash out period) before crossover to the other treatment arm.~No adverse event reported."
692810|NCT00289107|B3|Baseline|Total|Total of all reporting groups
692811|NCT00289107|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692812|NCT00289107|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692813|NCT00289107|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692814|NCT00289107|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692815|NCT00289107|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692816|NCT00289107|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692817|NCT00289107|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692818|NCT00289107|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692819|NCT00289094|B3|Baseline|Total|Total of all reporting groups
692820|NCT00289094|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692821|NCT00289094|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692822|NCT00289094|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692823|NCT00289094|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692824|NCT00289094|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692825|NCT00289094|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692826|NCT00289094|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
692827|NCT00289094|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
692828|NCT00289016|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692829|NCT00289016|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692830|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692855|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
693086|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
692831|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692832|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692833|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692834|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692835|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692836|NCT00289016|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
692837|NCT00288912|B4|Baseline|Total|Total of all reporting groups
692838|NCT00288912|B3|Baseline|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
692839|NCT00288912|B2|Baseline|Arm 2|Usual Medical Care
692840|NCT00288912|B1|Baseline|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
692841|NCT00288912|P3|Participant Flow|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
692842|NCT00288912|P2|Participant Flow|Arm 2|Usual Medical Care
692843|NCT00288912|P1|Participant Flow|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
692844|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
692845|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
692846|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
692847|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
692848|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
692849|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
692850|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
692851|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
692852|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
692853|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
692854|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
692916|NCT00288704|O1|Outcome|Placebo|
692917|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692856|NCT00288912|E3|Reported Event|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
692857|NCT00288912|E2|Reported Event|Arm 2|Usual Medical Care
692858|NCT00288912|E1|Reported Event|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
692859|NCT00288886|B3|Baseline|Total|Total of all reporting groups
692860|NCT00288886|B2|Baseline|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692861|NCT00288886|B1|Baseline|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692862|NCT00288886|P2|Participant Flow|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692863|NCT00288886|P1|Participant Flow|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692864|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692865|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692866|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692867|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692918|NCT00288704|O1|Outcome|Placebo|
692919|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692920|NCT00288704|O1|Outcome|Placebo|
692921|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692922|NCT00288704|O1|Outcome|Placebo|
692923|NCT00288704|E2|Reported Event|Placebo|
692924|NCT00288704|E1|Reported Event|Rilonacept 160 mg|
693087|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693088|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693089|NCT00287729|E2|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
692868|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692869|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692870|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692871|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692872|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692873|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692874|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692875|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692876|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692877|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692992|NCT00288574|B2|Baseline|Placebo|Placebo group
692993|NCT00288574|B1|Baseline|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
692994|NCT00288574|P2|Participant Flow|Placebo|Placebo group
692878|NCT00288886|E2|Reported Event|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
692879|NCT00288886|E1|Reported Event|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
692880|NCT00288860|B3|Baseline|Total|Total of all reporting groups
692881|NCT00288860|B2|Baseline|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
692882|NCT00288860|B1|Baseline|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
692883|NCT00288860|P2|Participant Flow|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
692884|NCT00288860|P1|Participant Flow|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
692885|NCT00288860|O2|Outcome|Treatment-As-Usual|"Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
692886|NCT00288860|O1|Outcome|Telephone Monitoring|"Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.~Telephone monitoring: Three months of biweekly telephone monitoring and support~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
692887|NCT00288860|O2|Outcome|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
692888|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
692889|NCT00288860|O2|Outcome|Treatment as Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
692890|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
692891|NCT00288860|E2|Reported Event|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
692892|NCT00288860|E1|Reported Event|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
692893|NCT00288704|B4|Baseline|Total|Total of all reporting groups
692894|NCT00288704|B3|Baseline|Open-Label Rilonacept 160 mg|57 new subjects entered the study directly into the OLE. This was not part of the double blind or randomized withdrawal portion of the results. The 44 subjects who completed Parts A and B were not included in this category for baseline characteristics. Pediatric subjects , age 7 or older, received rilonacept dosed 2.2 mg/kg weekly up to 160 mg during the OLE.
692895|NCT00288704|B2|Baseline|Rilonacept 160 mg|
692896|NCT00288704|B1|Baseline|Placebo|
692897|NCT00288704|P3|Participant Flow|Open-Label Extension (OLE) Rilonacept 160 mg|"After week 24 of study, all subjects received weekly injections of rilonacept 160 mg until the end of the study. This was not part of the double blind (Part A) or randomized withdrawal (Part B) portion of the results. Pediatric subjects received rilonacept dosed 2.2 mg/kg weekly up to 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week."
692898|NCT00288704|P2|Participant Flow|Rilonacept 160 mg|"If assigned, subjects received rilonacept 160 mg during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). Note: Between weeks 6 and 15 (Parts A and B), all subjects received rilonacept 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week. At baseline (week 0) subjects receive a loading dose of rilonacept 320 mg."
692899|NCT00288704|P1|Participant Flow|Placebo|If assigned, subjects received Placebo during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). No subject received Placebo during the open-label extension (after week 24). The drug is administered subcutaneously on a weekly basis.
692900|NCT00288704|O1|Outcome|Rilonacept 160 mg|
692901|NCT00288704|O1|Outcome|Rilonacept 160 mg|
692902|NCT00288704|O1|Outcome|Rilonacept 160 mg|
692903|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692904|NCT00288704|O1|Outcome|Placebo|
692905|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692906|NCT00288704|O1|Outcome|Placebo|
692907|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692908|NCT00288704|O1|Outcome|Placebo|
692909|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692910|NCT00288704|O1|Outcome|Placebo|
692911|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692912|NCT00288704|O1|Outcome|Placebo|
692913|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692914|NCT00288704|O1|Outcome|Placebo|
692915|NCT00288704|O2|Outcome|Rilonacept 160 mg|
692925|NCT00288639|B1|Baseline|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692926|NCT00288639|P1|Participant Flow|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692927|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692928|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692929|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692930|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692931|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692932|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692933|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692934|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692935|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692936|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692937|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692938|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692939|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692995|NCT00288574|P1|Participant Flow|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
692940|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692941|NCT00288639|E1|Reported Event|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
692942|NCT00288626|B1|Baseline|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692943|NCT00288626|P1|Participant Flow|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692944|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692945|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692946|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692947|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692996|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
692997|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
692998|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
692999|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
693000|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
693001|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
692948|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692949|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692950|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692951|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692952|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692953|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692954|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
693002|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
693003|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
693004|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
693005|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
693006|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
693007|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
692955|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692956|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692957|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692958|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692959|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692960|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692961|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
693008|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
693009|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
693010|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
693011|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
693012|NCT00288574|O2|Outcome|Placebo|placebo to match fluoxetine
693013|NCT00288574|O1|Outcome|Fluoxetine|fluoxetine up to 80 mg per day
692962|NCT00288626|O1|Outcome|HDIT and HCT|Participants received Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692963|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692964|NCT00288626|E1|Reported Event|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until > 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
692965|NCT00288600|B3|Baseline|Total|Total of all reporting groups
692966|NCT00288600|B2|Baseline|Control Group- Normal Saline|"Normal Saline solution and Phototherapy~Normal saline solution: Normal saline solution 10 ml/Kg"
692967|NCT00288600|B1|Baseline|Experimental Group - Immunoglobulin|"Intravenous Immunoglobulin and Phototherapy~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
692968|NCT00288600|P2|Participant Flow|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
692969|NCT00288600|P1|Participant Flow|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
692970|NCT00288600|O2|Outcome|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
692971|NCT00288600|O1|Outcome|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
692972|NCT00288600|E2|Reported Event|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
692973|NCT00288600|E1|Reported Event|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
692974|NCT00288587|B3|Baseline|Total|Total of all reporting groups
692975|NCT00288587|B2|Baseline|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692976|NCT00288587|B1|Baseline|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692977|NCT00288587|P2|Participant Flow|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692978|NCT00288587|P1|Participant Flow|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692979|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692980|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692981|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692982|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692983|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692984|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692985|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692986|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692987|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692988|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692989|NCT00288587|E2|Reported Event|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
692990|NCT00288587|E1|Reported Event|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
692991|NCT00288574|B3|Baseline|Total|Total of all reporting groups
693028|NCT00288080|B2|Baseline|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693029|NCT00288080|B1|Baseline|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693030|NCT00288080|P2|Participant Flow|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693031|NCT00288080|P1|Participant Flow|Androgen Suppression + Radiation Therapy (RT)|Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693032|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693033|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693034|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693035|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693036|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693037|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693038|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693039|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693040|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693041|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693042|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693043|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693044|NCT00288080|E2|Reported Event|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
693045|NCT00288080|E1|Reported Event|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
693090|NCT00287729|E1|Reported Event|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693091|NCT00287716|B4|Baseline|Total|Total of all reporting groups
693092|NCT00287716|B3|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693046|NCT00288067|B1|Baseline|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
693047|NCT00288067|P1|Participant Flow|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
693048|NCT00288067|O2|Outcome|Fenretinide and Rituximab (Rituximab Pre Treated)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
693049|NCT00288067|O1|Outcome|Fenretinide and Rituximab (Rituximab Naive)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
693050|NCT00288067|O1|Outcome|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
693051|NCT00288067|E1|Reported Event|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
693052|NCT00288054|B1|Baseline|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
693053|NCT00288054|P1|Participant Flow|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
693054|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
693055|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
693056|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
693057|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
693058|NCT00288054|O1|Outcome|Cetuximab + Chest Radiation Therapy|
693059|NCT00288054|E1|Reported Event|Cetuximab + Chest Radiation Therapy|
693060|NCT00287872|B1|Baseline|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
693061|NCT00287872|P1|Participant Flow|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
693062|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
693063|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib thalidomide"
693064|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
693065|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
693066|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
693067|NCT00287872|E1|Reported Event|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
693068|NCT00287729|B3|Baseline|Total|Total of all reporting groups
693069|NCT00287729|B2|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693070|NCT00287729|B1|Baseline|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693071|NCT00287729|P2|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693072|NCT00287729|P1|Participant Flow|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693073|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693074|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693075|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693076|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693077|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693078|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693079|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693080|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693081|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693082|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693083|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693084|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693085|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693093|NCT00287716|B2|Baseline|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693094|NCT00287716|B1|Baseline|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693095|NCT00287716|P3|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693096|NCT00287716|P2|Participant Flow|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693097|NCT00287716|P1|Participant Flow|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693098|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693099|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693100|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693101|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693102|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693103|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693104|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693105|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693106|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693107|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693108|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693109|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693110|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693111|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693112|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693113|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693114|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693115|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693116|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693117|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693118|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693119|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693120|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693121|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693122|NCT00287716|E3|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
693123|NCT00287716|E2|Reported Event|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
693124|NCT00287716|E1|Reported Event|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
693125|NCT00287586|B3|Baseline|Total|Total of all reporting groups
693126|NCT00287586|B2|Baseline|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693127|NCT00287586|B1|Baseline|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693128|NCT00287586|P2|Participant Flow|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693129|NCT00287586|P1|Participant Flow|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693130|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693131|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693132|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693133|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693134|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693158|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
696439|NCT00279201|E4|Reported Event|Lispro LM Prior Glargine Addendum|
693135|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693136|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693137|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693138|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693139|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693140|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693141|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693142|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693143|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693144|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693145|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693146|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693147|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693148|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693149|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693150|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693151|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693152|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693153|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693154|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693155|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693156|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693157|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693159|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693160|NCT00287586|O2|Outcome|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693161|NCT00287586|O1|Outcome|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693162|NCT00287586|E2|Reported Event|Placebo|Participants received placebo-matching testosterone gel daily for 3 years.
693163|NCT00287586|E1|Reported Event|Testosterone|Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
693164|NCT00287365|B1|Baseline|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
693165|NCT00287365|P1|Participant Flow|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
693166|NCT00287365|O2|Outcome|GSTM1 Sufficient|GSTM1 sufficient mild asthmatics
693167|NCT00287365|O1|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
693168|NCT00287365|O2|Outcome|GSTM1 Sufficient|GSTM1 sufficient mild asthmatics
693169|NCT00287365|O1|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
693170|NCT00287365|O2|Outcome|GSTM1 Sufficient|GSTM1 sufficient mild asthmatics
693171|NCT00287365|O1|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
693172|NCT00287365|E1|Reported Event|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
693173|NCT00287339|B3|Baseline|Total|Total of all reporting groups
693174|NCT00287339|B2|Baseline|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
693175|NCT00287339|B1|Baseline|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
693176|NCT00287339|P2|Participant Flow|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
693177|NCT00287339|P1|Participant Flow|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
693178|NCT00287339|O2|Outcome|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
693179|NCT00287339|O1|Outcome|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
693180|NCT00287339|E2|Reported Event|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
693181|NCT00287339|E1|Reported Event|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
693182|NCT00287222|B1|Baseline|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
693183|NCT00287222|P1|Participant Flow|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
693184|NCT00287222|O1|Outcome|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
693185|NCT00287222|E1|Reported Event|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
693186|NCT00287118|B1|Baseline|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
693187|NCT00287118|P1|Participant Flow|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
693188|NCT00287118|O1|Outcome|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
693189|NCT00287118|E1|Reported Event|Efalizumab|Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
693190|NCT00287079|B3|Baseline|Total|Total of all reporting groups
693191|NCT00287079|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
693192|NCT00287079|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
693193|NCT00287079|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
693194|NCT00287079|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
693195|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
693196|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
693197|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
693198|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
693199|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
693200|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
693201|NCT00287079|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
693202|NCT00287079|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
693203|NCT00287053|B3|Baseline|Total|Total of all reporting groups
693204|NCT00287053|B2|Baseline|2. Active Medication|Active medication
693205|NCT00287053|B1|Baseline|1. Inactive Placebo Pill|Inactive placebo pill
693206|NCT00287053|P2|Participant Flow|2. Active Medication|Active medication
693207|NCT00287053|P1|Participant Flow|1. Inactive Placebo Pill|Inactive placebo pill
693208|NCT00287053|O2|Outcome|2. Active Medication|Active medication
693209|NCT00287053|O1|Outcome|1. Inactive Placebo Pill|Inactive placebo pill
693210|NCT00287053|E2|Reported Event|2. Active Medication|Active medication
693211|NCT00287053|E1|Reported Event|1. Inactive Placebo Pill|Inactive placebo pill
693212|NCT00286949|B1|Baseline|Atomoxetine|Atomoxetine (Strattera): Open label, no comparator
693213|NCT00286949|P1|Participant Flow|Atomoxetine Open Label|This open-label, uncontrolled, single arm, flexible dose trial consisted of atomoxetine (Strattera) in 25 mg capsules initiated at 25 mg/day in the morning (Week 1) and advancing to 50mg/at (weeks 2-4), 75 mg/day (Week 5), and 100 mg/day (Weeks 6-8). Dose reductions were allowed to a minimum of 2.5 mg/day for intolerance.
693214|NCT00286949|O1|Outcome|Atomoxetine|"Active open label drug, no comparator~Atomoxetine (Strattera)"
693215|NCT00286949|O1|Outcome|Atomoxetine (Strattera)|"Open-Label Uncontrolled Active Drug Intervention, No comparator~Atomoxetine: Open Label uncontrolled active Drug intervention"
693216|NCT00286949|O1|Outcome|Atomoxetine Open Label|Active open label drug, no comparator; Atomoxetine (Strattera)
693217|NCT00286949|E1|Reported Event|Atomoxetine|"Open label, no comparator~Atomoxetine (Strattera)"
693218|NCT00286754|B4|Baseline|Total|Total of all reporting groups
693219|NCT00286754|B3|Baseline|Usual Care (UC)|treatment as usual for hypertension
693220|NCT00286754|B2|Baseline|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
693221|NCT00286754|B1|Baseline|Stage-Matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693222|NCT00286754|P3|Participant Flow|Usual Care (UC)|treatment as usual with no additional counseling
693223|NCT00286754|P2|Participant Flow|Health Education Intervention (HEI)|6 monthly phone calls of non-tailored counseling for diet, medication and exercise
693224|NCT00286754|P1|Participant Flow|Stage-matched Intervention (SM)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693225|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
693226|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
693227|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693228|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
693229|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
693230|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693231|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual
693232|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
693233|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693234|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
693235|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 months of non-tailored counseling for diet, medication and exercise
693236|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693237|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
693238|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
693239|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693240|NCT00286754|O3|Outcome|Usual Care (UC)|Treatment as usual for hypertension with no counseling
693241|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of non-tailored education about diet, medication and exercise recommendations
693242|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly calls targeting diet, medication and exercise adherence tailored using the Transtheoretical Model
693243|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
693244|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
693245|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693246|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
693247|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
693248|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693249|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
693250|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
693251|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693252|NCT00286754|E3|Reported Event|Usual Care (UC)|treatment as usual for hypertension
693253|NCT00286754|E2|Reported Event|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
693254|NCT00286754|E1|Reported Event|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
693255|NCT00286741|B3|Baseline|Total|Total of all reporting groups
693256|NCT00286741|B2|Baseline|Arm 2|control
693257|NCT00286741|B1|Baseline|Arm 1|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
693258|NCT00286741|P2|Participant Flow|Control|control
693259|NCT00286741|P1|Participant Flow|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
693260|NCT00286741|O2|Outcome|Treatment as Usual Control|control
693261|NCT00286741|O1|Outcome|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
693262|NCT00286741|O2|Outcome|Control|Treatment as Usual Control
693263|NCT00286741|O1|Outcome|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
693264|NCT00286741|E2|Reported Event|Control|Treatment as Usual Control
693265|NCT00286741|E1|Reported Event|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
693266|NCT00286728|B3|Baseline|Total|Total of all reporting groups
693267|NCT00286728|B2|Baseline|Arm 2 Usual Care|Usual care
693268|NCT00286728|B1|Baseline|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
693269|NCT00286728|P2|Participant Flow|Arm 2 Usual Care|Usual care
693270|NCT00286728|P1|Participant Flow|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
693271|NCT00286728|O2|Outcome|Arm 2 Usual Care|Usual care
693272|NCT00286728|O1|Outcome|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
693273|NCT00286728|E2|Reported Event|Arm 2 Usual Care|Usual care
693274|NCT00286728|E1|Reported Event|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
693275|NCT00286494|B4|Baseline|Total|Total of all reporting groups
693276|NCT00286494|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693277|NCT00286494|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693278|NCT00286494|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693279|NCT00286494|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693280|NCT00286494|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693281|NCT00286494|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693282|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693283|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693284|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693285|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693286|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693287|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693288|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693289|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693290|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693291|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693292|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693293|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693294|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693295|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693296|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693297|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693298|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693299|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693300|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693301|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693302|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693303|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693304|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693305|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693306|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693307|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693308|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693309|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693310|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693311|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693312|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693313|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693314|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693315|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693316|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693317|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693318|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693319|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693320|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693321|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693322|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693323|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693324|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
696948|NCT00275834|B3|Baseline|Zonisamide 400 mg|
693325|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693326|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693327|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693328|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693329|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693330|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693331|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693332|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693333|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693334|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693335|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693336|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693337|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693338|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693339|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693340|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693341|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693342|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693343|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693344|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693345|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693346|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693347|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693348|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693349|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693350|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693351|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693352|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693353|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693354|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693355|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693356|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693357|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693358|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693359|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693360|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693361|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693362|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693363|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
696949|NCT00275834|B2|Baseline|Zonisamide 200 mg|
693364|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693365|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693366|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693367|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693368|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693369|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693370|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693371|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693372|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693373|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693374|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693375|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693376|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693377|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693378|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693379|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693380|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693381|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693382|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693383|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693384|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693385|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693386|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693387|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693388|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693389|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693390|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693391|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693392|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693393|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693394|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693395|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693396|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693397|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693398|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693399|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693400|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693401|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693402|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
696950|NCT00275834|B1|Baseline|Placebo|
693403|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693404|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693405|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693406|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693407|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693408|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693409|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693410|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693411|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693412|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693413|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693414|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693415|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693416|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693417|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693418|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693419|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693420|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693421|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693422|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693423|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693424|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693425|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693426|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693427|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693428|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693429|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693430|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693431|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693432|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693433|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693434|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693435|NCT00286494|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693436|NCT00286494|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693437|NCT00286494|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
693438|NCT00286468|B4|Baseline|Total|Total of all reporting groups
693439|NCT00286468|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693440|NCT00286468|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693441|NCT00286468|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693442|NCT00286468|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693443|NCT00286468|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693444|NCT00286468|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693445|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693446|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693447|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693448|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693449|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693450|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693451|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693452|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693453|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693454|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693455|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693456|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693457|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693458|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693459|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693460|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693461|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693462|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693463|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693464|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693465|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693466|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693467|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693468|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693469|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693470|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693471|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693472|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693473|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693474|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693475|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693476|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693477|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693478|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693479|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693480|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693481|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693482|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693483|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693484|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693485|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693486|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693487|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693488|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693489|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693490|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693491|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693492|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693493|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693494|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693495|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693496|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693497|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693498|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693499|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693500|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693501|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693502|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693503|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693504|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693505|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693506|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693507|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693508|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693509|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693510|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693511|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693512|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693513|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693514|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693515|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693516|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693517|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693518|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693519|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693520|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693521|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693522|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693523|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693524|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693525|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693526|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693527|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693528|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693529|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693530|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693531|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693532|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693533|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693534|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693535|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693536|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693537|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693538|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693539|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693540|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693541|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693542|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693543|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693544|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693545|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693546|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693547|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693548|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693549|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693550|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693551|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693552|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693553|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693554|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693555|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693556|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693557|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693558|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693559|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693560|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693561|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693562|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693563|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693564|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693565|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693566|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693567|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693568|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693569|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693570|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693571|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693572|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693573|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693574|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693575|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693576|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693577|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693578|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693579|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693580|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693581|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693582|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693583|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693584|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693585|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693586|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693587|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693588|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693589|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693590|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693591|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693592|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693593|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693594|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693595|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693596|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693597|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693598|NCT00286468|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693599|NCT00286468|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
693600|NCT00286468|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
693601|NCT00286455|B4|Baseline|Total|Total of all reporting groups
693602|NCT00286455|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693603|NCT00286455|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693604|NCT00286455|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693605|NCT00286455|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693606|NCT00286455|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693607|NCT00286455|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693608|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693609|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693610|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693611|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693612|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693613|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693614|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693615|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693616|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693617|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693618|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693619|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693620|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693621|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693622|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693623|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693624|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693625|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693626|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693627|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693628|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693629|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693630|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693631|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693632|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693633|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693634|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693635|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693636|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693637|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693638|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693639|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693640|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693641|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693642|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693643|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693644|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693645|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693646|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693647|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693648|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693649|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693650|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
694088|NCT00286182|O2|Outcome|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
693651|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693652|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693653|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693654|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693655|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693656|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693657|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693658|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693659|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693660|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693661|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693662|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693663|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693664|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693665|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693666|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693667|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693668|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693669|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693670|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693671|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693672|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693673|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693674|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693675|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693676|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693677|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693678|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693679|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693680|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693681|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693682|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693683|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693684|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693685|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693686|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693687|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693688|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693689|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693690|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693691|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693692|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693693|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693694|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693695|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693696|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693697|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693698|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693699|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693700|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693701|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693702|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693703|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693704|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693705|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693706|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693707|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693708|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693709|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693710|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693711|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693712|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693713|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693714|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693715|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693716|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693717|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693718|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693719|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693720|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693721|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693722|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693723|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693724|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693725|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693726|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693727|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693728|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693729|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693730|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693731|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693732|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693733|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693734|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693735|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693736|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693737|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693738|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693739|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693740|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693741|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693742|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693743|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693744|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693745|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693746|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693747|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693748|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693749|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693750|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693751|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693752|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693753|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693754|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693755|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693756|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693757|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693758|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693759|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693760|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693761|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693762|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693763|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693764|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693765|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693766|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693767|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693768|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693769|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693770|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693771|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693772|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693773|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693774|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693775|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693776|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693777|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693778|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693779|NCT00286455|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
693780|NCT00286455|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
693781|NCT00286455|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
693782|NCT00286442|B4|Baseline|Total|Total of all reporting groups
693783|NCT00286442|B3|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693784|NCT00286442|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693785|NCT00286442|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693786|NCT00286442|P3|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693787|NCT00286442|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693788|NCT00286442|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693789|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693790|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693791|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693792|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693793|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693794|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693795|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693796|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693797|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693798|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693799|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693800|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693801|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693802|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693803|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693804|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693805|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693806|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693807|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693808|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693809|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693810|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693811|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693812|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693813|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693814|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693815|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693816|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693817|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693818|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693819|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693820|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693821|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693822|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693823|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693824|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693825|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693826|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693827|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693828|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693829|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693830|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693831|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693832|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693833|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693834|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693835|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693836|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693837|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693838|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693839|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693840|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693841|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693842|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693843|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693844|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693845|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693846|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693847|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693848|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693849|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693850|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693851|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693852|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693853|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693854|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693855|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693856|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693857|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693858|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693859|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693860|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693861|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693862|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693863|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693864|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693865|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693866|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693867|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693868|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693869|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693870|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693871|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693872|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693873|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693874|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693875|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693876|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693877|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693878|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693879|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693880|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693881|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693882|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693883|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693884|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693885|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693886|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693887|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693888|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693889|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693890|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693891|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693892|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693893|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693894|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693895|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693896|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693897|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693898|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693899|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693900|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693901|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693902|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693903|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693904|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693905|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693906|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693907|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693908|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693909|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693910|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693911|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693912|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693913|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693914|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693915|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693916|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693917|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693918|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693919|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693920|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693921|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693922|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693923|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693924|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693925|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693926|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693927|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693928|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693929|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693930|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693931|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693932|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693933|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693934|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693935|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693936|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693937|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693938|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693939|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693940|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693941|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693942|NCT00286442|E3|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
693943|NCT00286442|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693944|NCT00286442|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
693945|NCT00286429|B4|Baseline|Total|Total of all reporting groups
693946|NCT00286429|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693947|NCT00286429|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693948|NCT00286429|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693949|NCT00286429|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693950|NCT00286429|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693951|NCT00286429|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693952|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693953|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693954|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693955|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693956|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693957|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693958|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693959|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693960|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693961|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693962|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693963|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693964|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693965|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693966|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693967|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693968|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693969|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693970|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693971|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693972|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693973|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693974|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693975|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693976|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693977|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693978|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693979|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693980|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693981|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693982|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693983|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693984|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693985|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693986|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693987|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693988|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693989|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693990|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693991|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693992|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693993|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693994|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693995|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693996|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
693997|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693998|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
693999|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694000|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694001|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694002|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694003|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694004|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694005|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694006|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694007|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694008|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694009|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694010|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694011|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694012|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694013|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694014|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694015|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694016|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694017|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694018|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694019|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694020|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694021|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694022|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694023|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694024|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694025|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694026|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694027|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694028|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694029|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694030|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694031|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694032|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694033|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694034|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694035|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694036|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694037|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694038|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694039|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694040|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694041|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694042|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694043|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694044|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694045|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694046|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694047|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694048|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694049|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694050|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694051|NCT00286429|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694052|NCT00286429|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
694053|NCT00286429|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
694054|NCT00286325|B1|Baseline|Treated|Open label study subjects all treated with rituximab
694055|NCT00286325|P1|Participant Flow|Treated|Open label study subjects all treated with rituximab
694056|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
694057|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
694058|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
694059|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
694060|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
694061|NCT00286325|E1|Reported Event|Treated|Open label study subjects all treated with rituximab
694062|NCT00286221|B5|Baseline|Total|Total of all reporting groups
694063|NCT00286221|B4|Baseline|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694064|NCT00286221|B3|Baseline|Infratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694065|NCT00286221|B2|Baseline|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes pro re nata (PRN) (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694116|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
696951|NCT00275834|P3|Participant Flow|Zonisamide 400 mg|
694066|NCT00286221|B1|Baseline|Supratentorial PCA Fentanyl|PCA fentanyl: Patient controlled analgesia (PC fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694067|NCT00286221|P4|Participant Flow|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694068|NCT00286221|P3|Participant Flow|Infratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694069|NCT00286221|P2|Participant Flow|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694070|NCT00286221|P1|Participant Flow|Supratentorial PCA Fentanyl|PCA fentanyl: Patient controlled analgesia (PCA) fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694071|NCT00286221|O4|Outcome|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694072|NCT00286221|O3|Outcome|Infratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694073|NCT00286221|O2|Outcome|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694074|NCT00286221|O1|Outcome|Supratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694075|NCT00286221|O4|Outcome|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694076|NCT00286221|O3|Outcome|Infratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694077|NCT00286221|O2|Outcome|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694078|NCT00286221|O1|Outcome|Supratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694079|NCT00286221|E4|Reported Event|Infratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694080|NCT00286221|E3|Reported Event|Infratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694081|NCT00286221|E2|Reported Event|Supratentorial PRN Fentanyl|PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
694082|NCT00286221|E1|Reported Event|Supratentorial PCA Fentanyl|PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (“lockout”) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
694083|NCT00286182|B3|Baseline|Total|Total of all reporting groups
694084|NCT00286182|B2|Baseline|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
694085|NCT00286182|B1|Baseline|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
694086|NCT00286182|P2|Participant Flow|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
694087|NCT00286182|P1|Participant Flow|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
694089|NCT00286182|O1|Outcome|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
694090|NCT00286182|E2|Reported Event|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
694091|NCT00286182|E1|Reported Event|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
694092|NCT00286156|B4|Baseline|Total|Total of all reporting groups
694093|NCT00286156|B3|Baseline|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
694094|NCT00286156|B2|Baseline|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
694095|NCT00286156|B1|Baseline|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
694096|NCT00286156|P3|Participant Flow|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
694097|NCT00286156|P2|Participant Flow|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
694098|NCT00286156|P1|Participant Flow|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
694099|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
694100|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
694101|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
694102|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
694103|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
694104|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
694105|NCT00286156|E3|Reported Event|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
694106|NCT00286156|E2|Reported Event|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
694107|NCT00286156|E1|Reported Event|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
694108|NCT00286091|B3|Baseline|Total|Total of all reporting groups
694109|NCT00286091|B2|Baseline|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694110|NCT00286091|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694111|NCT00286091|P2|Participant Flow|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694112|NCT00286091|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694113|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694114|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694115|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694159|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694160|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694117|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694118|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694119|NCT00286091|E4|Reported Event|OLE: Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
694120|NCT00286091|E3|Reported Event|OLE: Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension (OLE) phase.
694121|NCT00286091|E2|Reported Event|DB: Denosumab 120 mg Q4W|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase.
694122|NCT00286091|E1|Reported Event|DB: Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
694123|NCT00286078|B3|Baseline|Total|Total of all reporting groups
694124|NCT00286078|B2|Baseline|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
694125|NCT00286078|B1|Baseline|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
694126|NCT00286078|P2|Participant Flow|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
694127|NCT00286078|P1|Participant Flow|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
694128|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
694129|NCT00286078|O1|Outcome|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
694130|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
694131|NCT00286078|O1|Outcome|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
694132|NCT00286078|E2|Reported Event|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
694133|NCT00286078|E1|Reported Event|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
694134|NCT00285857|B1|Baseline|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
694135|NCT00285857|P1|Participant Flow|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
694136|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
694137|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
694138|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
694139|NCT00285857|O5|Outcome|Baseline Biopsy Acellular|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) generated a sample that was acellular
694140|NCT00285857|O4|Outcome|Baseline Carcinoma in Situ or Invasive Cancer (CIS/IC)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of carcinoma in situ or invasive cancer
694141|NCT00285857|O3|Outcome|Baseline Proliferative Breast Disease With Atypia (PBD+A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease with atypia
694142|NCT00285857|O2|Outcome|Baseline Proliferative Breast Disease Without Atypia (PBD-A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease without atypia
694143|NCT00285857|O1|Outcome|Baseline Non-proliferative Breast Disease (NPBD)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of non-proliferative breast disease
694144|NCT00285857|E1|Reported Event|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
694145|NCT00285818|B3|Baseline|Total|Total of all reporting groups
694146|NCT00285818|B2|Baseline|Placebo|"Patients receive a placebo pill one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
694147|NCT00285818|B1|Baseline|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
694148|NCT00285818|P2|Participant Flow|Placebo|"Patients receive a placebo capsule one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
694149|NCT00285818|P1|Participant Flow|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
694150|NCT00285818|O2|Outcome|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
694151|NCT00285818|O1|Outcome|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
694152|NCT00285818|E2|Reported Event|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
694153|NCT00285818|E1|Reported Event|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
694154|NCT00285779|B3|Baseline|Total|Total of all reporting groups
694155|NCT00285779|B2|Baseline|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694156|NCT00285779|B1|Baseline|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694157|NCT00285779|P2|Participant Flow|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694158|NCT00285779|P1|Participant Flow|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694162|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694163|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694164|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694165|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694166|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694167|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694168|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694169|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694170|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694171|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694172|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694173|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694174|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694175|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694176|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694177|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694178|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694179|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694180|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694181|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694182|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694183|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694184|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694185|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694186|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694187|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694188|NCT00285779|E2|Reported Event|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
694189|NCT00285779|E1|Reported Event|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
694190|NCT00285649|B4|Baseline|Total|Total of all reporting groups
694191|NCT00285649|B3|Baseline|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
694192|NCT00285649|B2|Baseline|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
694193|NCT00285649|B1|Baseline|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
694194|NCT00285649|P3|Participant Flow|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
694195|NCT00285649|P2|Participant Flow|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
694196|NCT00285649|P1|Participant Flow|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
694197|NCT00285649|O3|Outcome|Usual Medical Care|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
694198|NCT00285649|O2|Outcome|LVVA-SM|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
694199|NCT00285649|O1|Outcome|HVLA-SM|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
694200|NCT00285649|E3|Reported Event|Usual Medical Care*|"Usual Medical Care, Active Comparator, advice, exercises and medications~Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)"
694201|NCT00285649|E2|Reported Event|LVVA-SM*|"LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation~LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation"
694202|NCT00285649|E1|Reported Event|HVLA-SM*|"HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation~HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation"
694203|NCT00285584|B3|Baseline|Total|Total of all reporting groups
694204|NCT00285584|B2|Baseline|Placebo|Participants in this arm received placebo.
694205|NCT00285584|B1|Baseline|Bupropion|Participants in this arm received bupropion.
694206|NCT00285584|P2|Participant Flow|Placebo|Participants in this arm received placebo.
694207|NCT00285584|P1|Participant Flow|Bupropion|Participants in this arm received bupropion.
694208|NCT00285584|O2|Outcome|Placebo|
694209|NCT00285584|O1|Outcome|Bupropion|
694210|NCT00285584|O2|Outcome|Placebo|Participants in this arm received placebo.
694211|NCT00285584|O1|Outcome|Bupropion|Participants in this arm received bupropion.
694212|NCT00285584|O2|Outcome|Placebo|
694213|NCT00285584|O1|Outcome|Bupropion|
694214|NCT00285584|O2|Outcome|Placebo|6 months
694215|NCT00285584|O1|Outcome|Bupropion|6 months
694216|NCT00285584|E2|Reported Event|Placebo|Participants in this arm received placebo.
694217|NCT00285584|E1|Reported Event|Bupropion|Participants in this arm received bupropion.
694219|NCT00285467|B2|Baseline|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
694220|NCT00285467|B1|Baseline|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
694221|NCT00285467|P2|Participant Flow|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
694222|NCT00285467|P1|Participant Flow|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
694223|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
694224|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
694225|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
694226|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
694227|NCT00285467|E2|Reported Event|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
694228|NCT00285467|E1|Reported Event|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
694229|NCT00285246|B1|Baseline|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
694230|NCT00285246|P1|Participant Flow|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
694231|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
694232|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
694233|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
694234|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
694235|NCT00285246|E1|Reported Event|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
694236|NCT00285207|B3|Baseline|Total|Total of all reporting groups
694237|NCT00285207|B2|Baseline|A007|Experimental A007
694238|NCT00285207|B1|Baseline|Placebo|Placebo (no treatment)
694239|NCT00285207|P2|Participant Flow|A007|Experimental A007
694240|NCT00285207|P1|Participant Flow|Placebo|Placebo (no treatment)
694241|NCT00285207|O2|Outcome|A007|Experimental A007
694242|NCT00285207|O1|Outcome|Placebo|Placebo (no treatment)
694243|NCT00285207|E2|Reported Event|A007|Experimental A007
694244|NCT00285207|E1|Reported Event|Placebo|Placebo (no treatment)
694245|NCT00285012|B3|Baseline|Total|Total of all reporting groups
694246|NCT00285012|B2|Baseline|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694247|NCT00285012|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694248|NCT00285012|P2|Participant Flow|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694249|NCT00285012|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694250|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694251|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694252|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694253|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694254|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694255|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694256|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694257|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694258|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694259|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694260|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694261|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694262|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694263|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694264|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694351|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694265|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694266|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694267|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694268|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694269|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694270|NCT00285012|E2|Reported Event|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694271|NCT00285012|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
694272|NCT00284934|B3|Baseline|Total|Total of all reporting groups
694273|NCT00284934|B2|Baseline|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694274|NCT00284934|B1|Baseline|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694275|NCT00284934|P2|Participant Flow|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694276|NCT00284934|P1|Participant Flow|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694277|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694278|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694279|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694280|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694281|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694282|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694283|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694352|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694609|NCT00283686|E1|Reported Event|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694284|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694285|NCT00284934|E2|Reported Event|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694286|NCT00284934|E1|Reported Event|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
694287|NCT00284856|B4|Baseline|Total|Total of all reporting groups
694288|NCT00284856|B3|Baseline|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694289|NCT00284856|B2|Baseline|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
694290|NCT00284856|B1|Baseline|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694291|NCT00284856|P3|Participant Flow|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694292|NCT00284856|P2|Participant Flow|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
694293|NCT00284856|P1|Participant Flow|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694294|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694295|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
694296|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694297|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694298|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
694299|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694300|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694301|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
694302|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694303|NCT00284856|E3|Reported Event|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694304|NCT00284856|E2|Reported Event|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
694305|NCT00284856|E1|Reported Event|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
694306|NCT00284739|B3|Baseline|Total|Total of all reporting groups
694307|NCT00284739|B2|Baseline|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
694308|NCT00284739|B1|Baseline|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
694309|NCT00284739|P2|Participant Flow|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
694310|NCT00284739|P1|Participant Flow|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
694311|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
694312|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
694313|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
694314|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
694315|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
694316|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
694317|NCT00284739|E2|Reported Event|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
694318|NCT00284739|E1|Reported Event|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
694319|NCT00284557|B3|Baseline|Total|Total of all reporting groups
694353|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694354|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694355|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694610|NCT00283595|B3|Baseline|Total|Total of all reporting groups
694320|NCT00284557|B2|Baseline|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
694321|NCT00284557|B1|Baseline|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
694322|NCT00284557|P2|Participant Flow|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
694323|NCT00284557|P1|Participant Flow|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
694324|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
694325|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
694326|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
694327|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
694328|NCT00284557|E2|Reported Event|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
694329|NCT00284557|E1|Reported Event|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
694330|NCT00284518|B5|Baseline|Total|Total of all reporting groups
694331|NCT00284518|B4|Baseline|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694332|NCT00284518|B3|Baseline|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694333|NCT00284518|B2|Baseline|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694334|NCT00284518|B1|Baseline|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694335|NCT00284518|P4|Participant Flow|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694336|NCT00284518|P3|Participant Flow|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694337|NCT00284518|P2|Participant Flow|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694338|NCT00284518|P1|Participant Flow|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694339|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694340|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694341|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694342|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694343|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694344|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694345|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694346|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694347|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694348|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694349|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694350|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694356|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694357|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694358|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694359|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694360|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694361|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694362|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694363|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694364|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694365|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694366|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694367|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694368|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694369|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694370|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694371|NCT00284518|E4|Reported Event|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
694372|NCT00284518|E3|Reported Event|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
694373|NCT00284518|E2|Reported Event|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
694374|NCT00284518|E1|Reported Event|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
694375|NCT00284180|B3|Baseline|Total|Total of all reporting groups
694376|NCT00284180|B2|Baseline|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
694377|NCT00284180|B1|Baseline|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
694378|NCT00284180|P2|Participant Flow|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
694379|NCT00284180|P1|Participant Flow|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
694380|NCT00284180|O2|Outcome|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2
694381|NCT00284180|O1|Outcome|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
694382|NCT00284180|E2|Reported Event|Vinflunine/Trastuzumab|
694383|NCT00284180|E1|Reported Event|Vinflunine|
694384|NCT00284154|B1|Baseline|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
694385|NCT00284154|P1|Participant Flow|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
694386|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
694387|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
694388|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
694389|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
694390|NCT00284154|E1|Reported Event|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
694391|NCT00284141|B1|Baseline|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694392|NCT00284141|P1|Participant Flow|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694393|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694394|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
694395|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
694396|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694397|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694611|NCT00283595|B2|Baseline|Placebo Group|Treatment with Placebo
694398|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694399|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694400|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694401|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694402|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
694403|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
694404|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
694405|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
694406|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694407|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
694408|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
694409|NCT00284141|E1|Reported Event|4 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
694410|NCT00284089|B5|Baseline|Total|Total of all reporting groups
694411|NCT00284089|B4|Baseline|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
694412|NCT00284089|B3|Baseline|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
694413|NCT00284089|B2|Baseline|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
694414|NCT00284089|B1|Baseline|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
694415|NCT00284089|P4|Participant Flow|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
694416|NCT00284089|P3|Participant Flow|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
694438|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694480|NCT00283842|B3|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694612|NCT00283595|B1|Baseline|Recombinant Human Growth Hormone Group|Treatment with rHGH
694417|NCT00284089|P2|Participant Flow|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
694418|NCT00284089|P1|Participant Flow|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
694419|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694420|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694421|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694422|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694423|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694424|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694425|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694426|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694427|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694428|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694429|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
694430|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
694431|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
694432|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
694433|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694434|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694435|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694436|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694437|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
694605|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694439|NCT00284089|E4|Reported Event|Extension Group A+B: Ranibizumab 0.5 mg|In the extension phase, all patients received an intravitreal injection of 0.5 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
694440|NCT00284089|E3|Reported Event|Extension Group A+B: Ranibizumab 0.3 mg|In the extension phase, enrolled patients received an intravitreal injection of 0.3 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
694441|NCT00284089|E2|Reported Event|Core Group A+B: Ranibizumab 0.5 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.5 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye.
694442|NCT00284089|E1|Reported Event|Core Group A+B: Ranibizumab 0.3 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.3 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye.
694443|NCT00284050|B4|Baseline|Total|Total of all reporting groups
694444|NCT00284050|B3|Baseline|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694445|NCT00284050|B2|Baseline|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694446|NCT00284050|B1|Baseline|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694447|NCT00284050|P3|Participant Flow|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694448|NCT00284050|P2|Participant Flow|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694449|NCT00284050|P1|Participant Flow|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694450|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694451|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694452|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694453|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694479|NCT00283842|B4|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694454|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694455|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694456|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694457|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694458|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694459|NCT00284050|E3|Reported Event|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694460|NCT00284050|E2|Reported Event|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694461|NCT00284050|E1|Reported Event|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
694462|NCT00283868|B3|Baseline|Total|Total of all reporting groups
694463|NCT00283868|B2|Baseline|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
694464|NCT00283868|B1|Baseline|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
694465|NCT00283868|P2|Participant Flow|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
694466|NCT00283868|P1|Participant Flow|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
694467|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
694468|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
694469|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
694470|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
694471|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
694472|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
694473|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
694474|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
694475|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
694476|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
694477|NCT00283842|B6|Baseline|Total|Total of all reporting groups
694478|NCT00283842|B5|Baseline|Placebo|
694481|NCT00283842|B2|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694482|NCT00283842|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694483|NCT00283842|P5|Participant Flow|Placebo|
694484|NCT00283842|P4|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694485|NCT00283842|P3|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694486|NCT00283842|P2|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694487|NCT00283842|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694488|NCT00283842|O5|Outcome|Placebo|
694489|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694490|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694491|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694492|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694493|NCT00283842|O5|Outcome|Placebo|
694494|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694495|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694496|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694497|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694498|NCT00283842|E5|Reported Event|Placebo|
694499|NCT00283842|E4|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694500|NCT00283842|E3|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694501|NCT00283842|E2|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694502|NCT00283842|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
694503|NCT00283816|B3|Baseline|Total|Total of all reporting groups
694504|NCT00283816|B2|Baseline|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
694505|NCT00283816|B1|Baseline|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
694506|NCT00283816|P2|Participant Flow|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
694507|NCT00283816|P1|Participant Flow|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
694508|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
694509|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
694510|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
694511|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
694512|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive
694513|NCT00283816|O1|Outcome|Metformin|metformin 2000mg in addition to oral contraceptive
694514|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
694515|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
694516|NCT00283816|E2|Reported Event|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
694517|NCT00283816|E1|Reported Event|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
694518|NCT00283803|B1|Baseline|IAS and Exisulind|Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.
694519|NCT00283803|P1|Participant Flow|Exisulind|"Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.~Exisulind: Exisulind 125 mg"
694520|NCT00283803|O1|Outcome|IAS and Exisulind|Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.
694521|NCT00283803|O1|Outcome|IAS and Exisulind|Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.
694606|NCT00283686|E4|Reported Event|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
703193|NCT00255840|B3|Baseline|Total|Total of all reporting groups
694522|NCT00283803|O1|Outcome|IAS and Exisulind|Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.
694523|NCT00283803|E1|Reported Event|Exisulind|"Patients will receive intermittent dosing of hormone therapy with commercially supplied LHRH agonist and antiandrogen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will continue treatment with Exisulind beyond the completion of the second cycle of hormone therapy until they meet criteria for discontinuation.~Exisulind: Exisulind 125 mg"
694524|NCT00283712|B3|Baseline|Total|Total of all reporting groups
694525|NCT00283712|B2|Baseline|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694526|NCT00283712|B1|Baseline|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694527|NCT00283712|P2|Participant Flow|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694528|NCT00283712|P1|Participant Flow|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694529|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694530|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694531|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694532|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694533|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694534|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694535|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694536|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694537|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694538|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694539|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694607|NCT00283686|E3|Reported Event|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694608|NCT00283686|E2|Reported Event|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694540|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694541|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694542|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694543|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694544|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694545|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694546|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694547|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694548|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694549|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694550|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694551|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694552|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694553|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694554|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694555|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694556|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694557|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694558|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
694559|NCT00283712|E2|Reported Event|Placebo|Subjects randomized to the Placebo group
694560|NCT00283712|E1|Reported Event|Infliximab|Subjects randomized to the Infliximab group
694561|NCT00283686|B5|Baseline|Total|Total of all reporting groups
694562|NCT00283686|B4|Baseline|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
694563|NCT00283686|B3|Baseline|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
694564|NCT00283686|B2|Baseline|ACE-I/ARB and Low BP|"ACE-I + ARB and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
694565|NCT00283686|B1|Baseline|ACE-I/ARB and Standard BP|"ACE-I + ARB and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
694566|NCT00283686|P4|Participant Flow|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
694567|NCT00283686|P3|Participant Flow|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
694568|NCT00283686|P2|Participant Flow|ACE-I/ARB and Low BP|"ACE-I + angiotensin-receptor blocker (ARB) and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
694569|NCT00283686|P1|Participant Flow|ACE-I/ARB and Standard BP|"ACE-I + angiotensin-receptor blocker (ARB) and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
694570|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694571|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694572|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694573|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694574|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694575|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694576|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694577|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694578|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694579|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694580|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694581|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694582|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694583|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694584|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694585|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694586|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694587|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694588|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694589|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694590|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694591|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694592|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694593|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694594|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694595|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694596|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694597|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694598|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694599|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694600|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694601|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
694602|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
694603|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
694604|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
694613|NCT00283595|P2|Participant Flow|Placebo (Subcutaneous Daily Injection)|Treatment with Placebo
694614|NCT00283595|P1|Participant Flow|Recombinant Human Growth Hormone(Subcutaneous Daily Injection)|Treatment with rHGH
694615|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
694616|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
694617|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
694618|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
694619|NCT00283595|E2|Reported Event|Placebo Group|Treatment with Placebo
694620|NCT00283595|E1|Reported Event|Recombinant Human Growth Hormone Group|Treatment with rHGH
694621|NCT00283504|B3|Baseline|Total|Total of all reporting groups
694622|NCT00283504|B2|Baseline|Non Eosinophilic Phenotype|participants received Xolair per standard clinical practice
694623|NCT00283504|B1|Baseline|Eosinophilic Phenotype|participants received Xolair per standard clinical practice
694624|NCT00283504|P2|Participant Flow|Non Eosinophilic Phenotype|participants received Xolair per standard clinical practice
694625|NCT00283504|P1|Participant Flow|Eosinophilic Phenotype|participants received Xolair per standard clinical practice
694626|NCT00283504|O2|Outcome|Non Eosinophilic Phenotype|participants received Xolair per standard clinical practice
694627|NCT00283504|O1|Outcome|Eosinophilic Phenotype|participants received Xolair per standard clinical practice
694628|NCT00283504|O2|Outcome|Non Eosinophilic Phenotype|participants received xolair per standard practice
694629|NCT00283504|O1|Outcome|Eosinophilic Phenotype|participants received xolair per standard practice
694630|NCT00283504|O2|Outcome|Non Eosinophilic Phenotype|participants received xolair per standard practice
694631|NCT00283504|O1|Outcome|Eosinophilic Phenotype|participants received xolair per standard practice
694632|NCT00283504|E2|Reported Event|Non Eosinophilic Phenotype|participants received xolair per standard practice
694633|NCT00283504|E1|Reported Event|Eosinophilic Phenotype|participants received xolair per standard practice
694634|NCT00283439|B5|Baseline|Total|Total of all reporting groups
694635|NCT00283439|B4|Baseline|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
694636|NCT00283439|B3|Baseline|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
694637|NCT00283439|B2|Baseline|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
694638|NCT00283439|B1|Baseline|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
694639|NCT00283439|P4|Participant Flow|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
694640|NCT00283439|P3|Participant Flow|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
694641|NCT00283439|P2|Participant Flow|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
694642|NCT00283439|P1|Participant Flow|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
694643|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
694644|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
694645|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
694646|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
694647|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
694648|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
694649|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
694650|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
694651|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
694652|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
694653|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
694654|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
694655|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
694656|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
694657|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
694658|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
694659|NCT00283439|E4|Reported Event|Romiplostim 1000 µg|
694660|NCT00283439|E3|Reported Event|Romiplostim 700 µg|
694661|NCT00283439|E2|Reported Event|Romiplostim 300 µg|
694662|NCT00283439|E1|Reported Event|Romiplostim 100 µg|
694663|NCT00283400|B5|Baseline|Total|Total of all reporting groups
694664|NCT00283400|B4|Baseline|Dosage Tier 4|25% human albumin 2.5 g/kg
694665|NCT00283400|B3|Baseline|Dosage Tier 3|25% human albumin 1.875 g/kg
694666|NCT00283400|B2|Baseline|Dosage Tier 2|25% human albumin 1.25 g/kg
694667|NCT00283400|B1|Baseline|Dosage Tier 1|25% human albumin 0.625 g/kg
694668|NCT00283400|P4|Participant Flow|Dosage Tier 4|25% human albumin2.5 g/kg
694669|NCT00283400|P3|Participant Flow|Dosage Tier 3|25% human albumin 1.875 g/kg
694670|NCT00283400|P2|Participant Flow|Dosage Tier 2|25% human albumin 1.25 g/kg
694671|NCT00283400|P1|Participant Flow|Dosage Tier 1|25% human albumin 0.625 g/kg
694672|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
694673|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
694674|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
694675|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
694676|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
694677|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
694678|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
694679|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
694680|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
694681|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
694682|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
694683|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
694684|NCT00283400|E4|Reported Event|Dosage Tier 4|25% human albumin 2.5 g/kg
694685|NCT00283400|E3|Reported Event|Dosage Tier 3|25% human albumin 1.875 g/kg
694686|NCT00283400|E2|Reported Event|Dosage Tier 2|25% human albumin 1.25 g/kg
694687|NCT00283400|E1|Reported Event|Dosage Tier 1|25% human albumin 0.625 g/kg
694688|NCT00283387|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and betaine first.
694689|NCT00283387|P2|Participant Flow|Placebo First, Then Betaine|Subjects received oral lactose placebo divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
694690|NCT00283387|P1|Participant Flow|Betaine First, Then Placebo|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old) divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral lactose placebo divided in two doses daily, for 2 months.
694691|NCT00283387|O2|Outcome|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
694692|NCT00283387|O1|Outcome|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
694693|NCT00283387|E2|Reported Event|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
694694|NCT00283387|E1|Reported Event|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
694695|NCT00283296|B1|Baseline|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
694696|NCT00283296|P1|Participant Flow|Endeavor Wheelchair|All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
694697|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
694698|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
694699|NCT00283296|O1|Outcome|Endeavor Wheelchair|All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
694700|NCT00283296|E1|Reported Event|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
694701|NCT00283244|B4|Baseline|Total|Total of all reporting groups
694702|NCT00283244|B3|Baseline|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694703|NCT00283244|B2|Baseline|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
694704|NCT00283244|B1|Baseline|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
694705|NCT00283244|P3|Participant Flow|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694706|NCT00283244|P2|Participant Flow|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
694707|NCT00283244|P1|Participant Flow|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
694708|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694709|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
694710|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
694711|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694712|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
694713|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
694714|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694715|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
694716|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
703687|NCT00253890|B1|Baseline|Trazodone|50-150mg at bedtime
694717|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694718|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
694719|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
694720|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694721|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21
694722|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
694723|NCT00283244|E3|Reported Event|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
694724|NCT00283244|E2|Reported Event|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
694725|NCT00283244|E1|Reported Event|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
694726|NCT00283075|B1|Baseline|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
694727|NCT00283075|P2|Participant Flow|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
694728|NCT00283075|P1|Participant Flow|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
694729|NCT00283075|O2|Outcome|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
694730|NCT00283075|O1|Outcome|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
694731|NCT00283075|O4|Outcome|Day 28|Tumor marker response at Day 28 after the first implantation.
694732|NCT00283075|O3|Outcome|Day 21|Tumor marker response at Day 21 after the first implantation.
694733|NCT00283075|O2|Outcome|Day 14|Tumor marker response at Day 14 after the first implantation.
694734|NCT00283075|O1|Outcome|Day 7|Tumor marker response at Day 7 after the first implantation.
694735|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
694736|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
694737|NCT00283075|E1|Reported Event|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
694738|NCT00283062|B5|Baseline|Total|Total of all reporting groups
694739|NCT00283062|B4|Baseline|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694740|NCT00283062|B3|Baseline|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694741|NCT00283062|B2|Baseline|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694742|NCT00283062|B1|Baseline|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694743|NCT00283062|P4|Participant Flow|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694744|NCT00283062|P3|Participant Flow|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694745|NCT00283062|P2|Participant Flow|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694746|NCT00283062|P1|Participant Flow|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694747|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694748|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694749|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694773|NCT00283062|E2|Reported Event|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694750|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694751|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694752|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694753|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694754|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694755|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694756|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694757|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694758|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694759|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694760|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694761|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694762|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694763|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694764|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694765|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694766|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694767|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694768|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
694769|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694770|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694771|NCT00283062|E4|Reported Event|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
694772|NCT00283062|E3|Reported Event|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
703688|NCT00253890|P2|Participant Flow|Placebo|1-3 capsules at bedtime
694774|NCT00283062|E1|Reported Event|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
694775|NCT00283049|B4|Baseline|Total|Total of all reporting groups
694776|NCT00283049|B3|Baseline|MET+SU + IG|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
694777|NCT00283049|B2|Baseline|MET + TZD + IG|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
694778|NCT00283049|B1|Baseline|SU + TZD + IG|Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
694779|NCT00283049|P3|Participant Flow|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694780|NCT00283049|P2|Participant Flow|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694781|NCT00283049|P1|Participant Flow|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694782|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694783|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694784|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694785|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694786|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694787|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694788|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694789|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694790|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694791|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694792|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694793|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694794|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694795|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694796|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694797|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694861|NCT00282867|B1|Baseline|Tight Control Group|target glucose level 70-110 mg/dL
694862|NCT00282867|P3|Participant Flow|Usual Care Group|target level 70 - 300 mg/dL
694798|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694799|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694800|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694801|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694802|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694803|NCT00283049|E3|Reported Event|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694804|NCT00283049|E2|Reported Event|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694805|NCT00283049|E1|Reported Event|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
694806|NCT00282984|B3|Baseline|Total|Total of all reporting groups
694807|NCT00282984|B2|Baseline|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694808|NCT00282984|B1|Baseline|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694809|NCT00282984|P2|Participant Flow|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694810|NCT00282984|P1|Participant Flow|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694811|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694812|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694813|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694814|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694815|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694816|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694817|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694818|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694819|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694820|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694821|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694822|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694823|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694863|NCT00282867|P2|Participant Flow|Loose Control Group|target glucose level 70 – 200 mg/dL
694824|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694825|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694826|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694827|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694828|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694829|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694830|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694831|NCT00282984|E2|Reported Event|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694832|NCT00282984|E1|Reported Event|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
694833|NCT00282971|B3|Baseline|Total|Total of all reporting groups
694834|NCT00282971|B2|Baseline|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
694835|NCT00282971|B1|Baseline|Inhaled Insulin|Inhaled insulin plus oral therapy
694836|NCT00282971|P2|Participant Flow|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
694837|NCT00282971|P1|Participant Flow|Inhaled Insulin|Inhaled insulin plus oral therapy
694838|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
694839|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
694840|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
694841|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
694842|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
694843|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
694844|NCT00282971|E2|Reported Event|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
694845|NCT00282971|E1|Reported Event|Inhaled Insulin|Inhaled insulin plus oral therapy
694846|NCT00282919|B1|Baseline|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694847|NCT00282919|P1|Participant Flow|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694848|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694849|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694850|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694851|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694852|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694853|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694854|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694855|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694856|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694857|NCT00282919|E1|Reported Event|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
694858|NCT00282867|B4|Baseline|Total|Total of all reporting groups
694859|NCT00282867|B3|Baseline|Usual Care Group|target level 70 - 300 mg/dL
694860|NCT00282867|B2|Baseline|Loose Control Group|target glucose level 70 – 200 mg/dL
694864|NCT00282867|P1|Participant Flow|Tight Control Group|target glucose level 70-110 mg/dL
694865|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
694866|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
694867|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
694868|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
694869|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
694870|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
694871|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
694872|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
694873|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
694874|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
694875|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
694876|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
694877|NCT00282828|B4|Baseline|Total|Total of all reporting groups
694878|NCT00282828|B3|Baseline|Sertraline and Placebo|Participants will take both sertraline and placebo
694879|NCT00282828|B2|Baseline|Venlafaxine|Participants will take venlafaxine only
694880|NCT00282828|B1|Baseline|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
694881|NCT00282828|P3|Participant Flow|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
694882|NCT00282828|P2|Participant Flow|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
694883|NCT00282828|P1|Participant Flow|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
694884|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
694885|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
694886|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
694887|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
694888|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
694889|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
694890|NCT00282828|E3|Reported Event|Sertraline and Placebo|Participants will take both sertraline and placebo
694891|NCT00282828|E2|Reported Event|Venlafaxine|Participants will take venlafaxine only
694892|NCT00282828|E1|Reported Event|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
694893|NCT00282815|B3|Baseline|Total|Total of all reporting groups
694894|NCT00282815|B2|Baseline|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
694895|NCT00282815|B1|Baseline|Active Continuous Positive Airway Pressure (CPAP)|
694896|NCT00282815|P2|Participant Flow|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
694897|NCT00282815|P1|Participant Flow|Active Continuous Positive Airway Pressure (CPAP)|
694898|NCT00282815|O2|Outcome|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
694899|NCT00282815|O1|Outcome|Active Continuous Positive Airway Pressure (CPAP)|
694900|NCT00282815|O1|Outcome|After Randomization|
694901|NCT00282815|O2|Outcome|Sham CPAP|
694902|NCT00282815|O1|Outcome|Active CPAP|
694903|NCT00282815|E2|Reported Event|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
694904|NCT00282815|E1|Reported Event|Active Continuous Positive Airway Pressure (CPAP)|
694905|NCT00282672|B5|Baseline|Total|Total of all reporting groups
694906|NCT00282672|B4|Baseline|HGD Radiofrequency Ablation|
694907|NCT00282672|B3|Baseline|HGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
694908|NCT00282672|B2|Baseline|LGD Radiofrequency Ablation|
694909|NCT00282672|B1|Baseline|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
694910|NCT00282672|P4|Participant Flow|HGD Radiofrequency Ablation|
694911|NCT00282672|P3|Participant Flow|HGD Sham Procedure First Then HGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
694912|NCT00282672|P2|Participant Flow|LGD Radiofrequency Ablation|
694913|NCT00282672|P1|Participant Flow|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
694914|NCT00282672|O1|Outcome|All Groups|
694915|NCT00282672|O1|Outcome|All Study Participants|
694916|NCT00282672|O1|Outcome|All Groups|
694917|NCT00282672|O1|Outcome|All Groups|
694918|NCT00282672|O1|Outcome|All Groups|
694919|NCT00282672|O1|Outcome|All Groups|
694920|NCT00282672|O1|Outcome|All Groups|
694921|NCT00282672|O1|Outcome|All Groups|
694922|NCT00282672|O1|Outcome|All Groups|
694923|NCT00282672|O2|Outcome|Treatment Patients|Patients randomized to Radiofrequency Ablation at start of study and underwent RFA treatment at randomization.
694924|NCT00282672|O1|Outcome|Sham Patients|Patients randomized to Sham Procedure arm.
694925|NCT00282672|O1|Outcome|All Groups|
694926|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
694927|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
694928|NCT00282672|O2|Outcome|LGD Radiofrequency Ablation|
694929|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
694930|NCT00282672|O3|Outcome|HGD to IMC|
694933|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
694934|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
694935|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
694936|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
694937|NCT00282672|O2|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
694938|NCT00282672|O1|Outcome|HGD Radiofrequency Ablation|
694939|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
694940|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
694941|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
694942|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
694943|NCT00282672|O2|Outcome|All HGD Patients|
694944|NCT00282672|O1|Outcome|All LGD Patients|
694945|NCT00282672|O1|Outcome|All Groups|
694946|NCT00282672|O2|Outcome|All HGD Patients|HGD: Sham procedure group crossed over to HGD: Radiofrequency group at 12 month
694947|NCT00282672|O1|Outcome|All LGD Patients|LGD: Sham procedure group crossed over to LGD: Radiofrequency group at 12 month
694948|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
694949|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|Crossed over to HGD: Radiofrequency
694950|NCT00282672|O2|Outcome|LGD:Radiofrequency|
694951|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|Crossed over to LGD:Radiofrequency
694952|NCT00282672|O2|Outcome|HGD:Radiofrequency|
694953|NCT00282672|O1|Outcome|LGD:Radiofrequency|
694954|NCT00282672|O2|Outcome|HGD:Radiofrequency Ablation|
694955|NCT00282672|O1|Outcome|LGD:Radiofrequency Ablation|
694956|NCT00282672|E4|Reported Event|HGD Radiofrequency Ablation|
694957|NCT00282672|E3|Reported Event|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
694958|NCT00282672|E2|Reported Event|LGD Radiofrequency Ablation|
694959|NCT00282672|E1|Reported Event|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
694960|NCT00282568|B1|Baseline|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694961|NCT00282568|P1|Participant Flow|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694962|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694963|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694964|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694965|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694992|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
694993|NCT00282464|O2|Outcome|Placebo|
695089|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
694966|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694967|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694968|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694969|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694970|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694971|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694972|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694973|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694974|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694975|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
695053|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
694976|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694977|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694978|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694979|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694980|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694981|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694982|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694983|NCT00282568|E1|Reported Event|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
694984|NCT00282464|B3|Baseline|Total|Total of all reporting groups
694985|NCT00282464|B2|Baseline|Placebo|
694986|NCT00282464|B1|Baseline|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
694987|NCT00282464|P2|Participant Flow|Placebo|
694988|NCT00282464|P1|Participant Flow|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
694989|NCT00282464|O2|Outcome|Placebo|
694990|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
694991|NCT00282464|O2|Outcome|Placebo|
695425|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
694994|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
694995|NCT00282464|O2|Outcome|Placebo|
694996|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
694997|NCT00282464|O2|Outcome|Placebo|
694998|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
694999|NCT00282464|O2|Outcome|Placebo|
695000|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695001|NCT00282464|O2|Outcome|Placebo|
695002|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695003|NCT00282464|O2|Outcome|Placebo|
695004|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695005|NCT00282464|O2|Outcome|Placebo|
695006|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695007|NCT00282464|O2|Outcome|Placebo|
695008|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695009|NCT00282464|O2|Outcome|Placebo|
695010|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695011|NCT00282464|O2|Outcome|Placebo|
695012|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695013|NCT00282464|O2|Outcome|Placebo|
695014|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695015|NCT00282464|O2|Outcome|Placebo|
695016|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695017|NCT00282464|O2|Outcome|Placebo|
695018|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695019|NCT00282464|O2|Outcome|Placebo|
695020|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695021|NCT00282464|O2|Outcome|Placebo|
695022|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695023|NCT00282464|O2|Outcome|Placebo|
695054|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695024|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695025|NCT00282464|O2|Outcome|Placebo|
695026|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695027|NCT00282464|O2|Outcome|Placebo|
695028|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695029|NCT00282464|O2|Outcome|Placebo|
695030|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695031|NCT00282464|O2|Outcome|Placebo|
695032|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695033|NCT00282464|E2|Reported Event|Placebo|
695034|NCT00282464|E1|Reported Event|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
695035|NCT00282438|B3|Baseline|Total|Total of all reporting groups
695036|NCT00282438|B2|Baseline|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
695037|NCT00282438|B1|Baseline|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
695038|NCT00282438|P2|Participant Flow|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
695039|NCT00282438|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
695040|NCT00282438|O2|Outcome|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
695041|NCT00282438|O1|Outcome|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
695042|NCT00282438|E2|Reported Event|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
695043|NCT00282438|E1|Reported Event|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
695044|NCT00282347|B3|Baseline|Total|Total of all reporting groups
695045|NCT00282347|B2|Baseline|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695046|NCT00282347|B1|Baseline|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695047|NCT00282347|P2|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695048|NCT00282347|P1|Participant Flow|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695049|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695050|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695051|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695052|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695426|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695055|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695056|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695057|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695058|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695059|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695060|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695061|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695062|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695063|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695064|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695065|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695066|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695067|NCT00282347|E4|Reported Event|Placebo - B Cell Follow-up Period|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695068|NCT00282347|E3|Reported Event|Rituximab - B Cell Follow-up Period|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695069|NCT00282347|E2|Reported Event|Placebo - Treatment and Safety Follow-up Periods|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695070|NCT00282347|E1|Reported Event|Rituximab - Treatment and Safety Follow-up Periods|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
695071|NCT00282334|B3|Baseline|Total|Total of all reporting groups
695072|NCT00282334|B2|Baseline|Telemonitoring of Home Blood Press|
695073|NCT00282334|B1|Baseline|Conventional Blood Pressure Monitoring|
695074|NCT00282334|P2|Participant Flow|Conventional|Conventional blood pressure monitoring
695075|NCT00282334|P1|Participant Flow|Telemonitoring|Telemonitoring of home blood pressure
695076|NCT00282334|O2|Outcome|Telemonitoring of Home Blood Press|
695077|NCT00282334|O1|Outcome|Conventional Blood Pressure Monitoring|
695078|NCT00282334|E2|Reported Event|Telemonitoring of Home Blood Press|
695079|NCT00282334|E1|Reported Event|Conventional Blood Pressure Monitoring|
695080|NCT00282308|B3|Baseline|Total|Total of all reporting groups
695081|NCT00282308|B2|Baseline|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695082|NCT00282308|B1|Baseline|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695083|NCT00282308|P3|Participant Flow|All Patients (Combined Groups A and B)|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
695084|NCT00282308|P2|Participant Flow|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695085|NCT00282308|P1|Participant Flow|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695086|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695087|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695088|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695090|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695091|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695092|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695093|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695094|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695095|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695096|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695097|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695098|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695099|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695100|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695101|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695102|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695103|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695104|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695105|NCT00282308|E6|Reported Event|Group B - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
695106|NCT00282308|E5|Reported Event|Group A - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
695107|NCT00282308|E4|Reported Event|Group B - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
695108|NCT00282308|E3|Reported Event|Group A - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
695109|NCT00282308|E2|Reported Event|Methotrexate (Group B) - Treatment Period|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695110|NCT00282308|E1|Reported Event|Rituximab + Methotrexate (Group A) - Treatment Period|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
695111|NCT00282295|B4|Baseline|Total|Total of all reporting groups
695112|NCT00282295|B3|Baseline|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695113|NCT00282295|B2|Baseline|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695114|NCT00282295|B1|Baseline|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695115|NCT00282295|P3|Participant Flow|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695116|NCT00282295|P2|Participant Flow|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695117|NCT00282295|P1|Participant Flow|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695118|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695119|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695120|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695427|NCT00281632|O3|Outcome|Pazopanib 800 mg All|800 milligrams (mg) pazopanib administered orally once daily All participants
695121|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695122|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695123|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695124|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695125|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695126|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695127|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695128|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695129|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695130|NCT00282295|O1|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695131|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695132|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695133|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695134|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695135|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695136|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695137|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695138|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695139|NCT00282295|O2|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695140|NCT00282295|O1|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695141|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695142|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695143|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695144|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695145|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695146|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695147|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695148|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695149|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695150|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695151|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695152|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695153|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695154|NCT00282295|O2|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695155|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695156|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695157|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695158|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695159|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695160|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695161|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695162|NCT00282295|E3|Reported Event|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695163|NCT00282295|E2|Reported Event|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
695164|NCT00282295|E1|Reported Event|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
695165|NCT00282282|B1|Baseline|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
695166|NCT00282282|P1|Participant Flow|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
695167|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus GVHD Prophylaxis|
695168|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
695169|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
695170|NCT00282282|E1|Reported Event|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
695171|NCT00282256|B1|Baseline|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695172|NCT00282256|P1|Participant Flow|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695173|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695174|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695175|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695176|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695177|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695178|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695179|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695180|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695181|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695428|NCT00281632|O2|Outcome|Pazopanib 800 mg Non-Responders|800 milligrams (mg) pazopanib administered orally once daily Non-Responders
695182|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695183|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695184|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695185|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695186|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695187|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695188|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695189|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695190|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695191|NCT00282256|E1|Reported Event|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
695192|NCT00282243|B1|Baseline|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695222|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695276|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695193|NCT00282243|P1|Participant Flow|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695194|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695195|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695196|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695197|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695198|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695199|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695200|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695201|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695268|NCT00282087|E1|Reported Event|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695269|NCT00282048|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695429|NCT00281632|O1|Outcome|Pazopanib 800 mg Responders|800 milligrams (mg) pazopanib administered orally once daily Responders
695202|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695203|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695204|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695205|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695206|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695207|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695208|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695209|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695210|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695270|NCT00282048|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695271|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695589|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695211|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695212|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695213|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695214|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695215|NCT00282243|E1|Reported Event|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
695216|NCT00282152|B3|Baseline|Total|Total of all reporting groups
695217|NCT00282152|B2|Baseline|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
695218|NCT00282152|B1|Baseline|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695219|NCT00282152|P2|Participant Flow|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
695220|NCT00282152|P1|Participant Flow|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695221|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
695223|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
695224|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695225|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
695226|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695227|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
695228|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695229|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
695230|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695231|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
695232|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695272|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695273|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695274|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695275|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695233|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
695234|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695235|NCT00282152|E2|Reported Event|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
695236|NCT00282152|E1|Reported Event|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
695237|NCT00282113|B4|Baseline|Total|Total of all reporting groups
695238|NCT00282113|B3|Baseline|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
695239|NCT00282113|B2|Baseline|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
695240|NCT00282113|B1|Baseline|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
695241|NCT00282113|P3|Participant Flow|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
695242|NCT00282113|P2|Participant Flow|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
695243|NCT00282113|P1|Participant Flow|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
695244|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
695245|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
695246|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
695247|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
695248|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
695249|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
695250|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
695251|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
695252|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
695253|NCT00282113|E3|Reported Event|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
695254|NCT00282113|E2|Reported Event|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
695255|NCT00282113|E1|Reported Event|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
695256|NCT00282087|B1|Baseline|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695257|NCT00282087|P1|Participant Flow|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
695258|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695259|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695260|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695261|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695262|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695263|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695264|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695265|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695266|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Number of major toxicity events
695267|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
695277|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695278|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695279|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695280|NCT00282048|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
695281|NCT00281957|B3|Baseline|Total|Total of all reporting groups
695282|NCT00281957|B2|Baseline|Arm II: Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
695283|NCT00281957|B1|Baseline|Arm I: Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
695284|NCT00281957|P2|Participant Flow|Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
695285|NCT00281957|P1|Participant Flow|Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
695286|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Sorafenib and Tipifarnib
695287|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Sorafenib and Temsirolimus
695288|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
695289|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
695290|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
695291|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
695292|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
695293|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
695294|NCT00281957|E2|Reported Event|Arm II|Sorafenib and Tipifarnib
695295|NCT00281957|E1|Reported Event|Arm I|Sorafenib and Temsirolimu
695296|NCT00281918|B3|Baseline|Total|Total of all reporting groups
695297|NCT00281918|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695298|NCT00281918|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695299|NCT00281918|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695300|NCT00281918|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695301|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695302|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695303|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695304|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695305|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695306|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695307|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695430|NCT00281632|O3|Outcome|Pazopanib 800 mg All|All participants administered 800 milligrams (mg) pazopanib administered orally once daily
695308|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695309|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695310|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695311|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695312|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695313|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695314|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695315|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695316|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695317|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695318|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695319|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695320|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695321|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695322|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695323|NCT00281918|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
695324|NCT00281918|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
695325|NCT00281879|B9|Baseline|Total|Total of all reporting groups
695326|NCT00281879|B8|Baseline|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
695383|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695327|NCT00281879|B7|Baseline|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
695328|NCT00281879|B6|Baseline|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
695329|NCT00281879|B5|Baseline|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
695330|NCT00281879|B4|Baseline|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
695331|NCT00281879|B3|Baseline|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
695332|NCT00281879|B2|Baseline|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
695333|NCT00281879|B1|Baseline|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
695334|NCT00281879|P8|Participant Flow|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
695335|NCT00281879|P7|Participant Flow|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
695336|NCT00281879|P6|Participant Flow|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
695384|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695431|NCT00281632|O2|Outcome|Pazopanib 800 mg Without Measurable Disease|Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
695337|NCT00281879|P5|Participant Flow|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
695338|NCT00281879|P4|Participant Flow|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
695339|NCT00281879|P3|Participant Flow|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
695340|NCT00281879|P2|Participant Flow|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
695341|NCT00281879|P1|Participant Flow|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
695342|NCT00281879|O8|Outcome|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
695343|NCT00281879|O7|Outcome|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
695344|NCT00281879|O6|Outcome|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
695345|NCT00281879|O5|Outcome|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
695346|NCT00281879|O4|Outcome|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
695424|NCT00281632|O1|Outcome|Pazopanib 800 mg|: 800 milligrams (mg) pazopanib administered orally once daily
695347|NCT00281879|O3|Outcome|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
695348|NCT00281879|O2|Outcome|Busulfan and Cyclophosphamide (Cytoxan)|
695349|NCT00281879|O1|Outcome|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|
695350|NCT00281879|E8|Reported Event|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
695351|NCT00281879|E7|Reported Event|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
695352|NCT00281879|E6|Reported Event|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
695353|NCT00281879|E5|Reported Event|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
695354|NCT00281879|E4|Reported Event|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
695355|NCT00281879|E3|Reported Event|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
695356|NCT00281879|E2|Reported Event|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
695357|NCT00281879|E1|Reported Event|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
695358|NCT00281840|B1|Baseline|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
695359|NCT00281840|P1|Participant Flow|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
695360|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|"bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.~docetaxel: docetaxel IV over 1 hour once a week for 8 weeks~conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection~radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks"
695361|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
695362|NCT00281840|E1|Reported Event|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
695363|NCT00281827|B1|Baseline|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695364|NCT00281827|P1|Participant Flow|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695365|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695366|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695367|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695368|NCT00281827|O1|Outcome|Intent-To-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695369|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695370|NCT00281827|O1|Outcome|Evaluable Patients|Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
695371|NCT00281827|E1|Reported Event|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
695372|NCT00281697|B3|Baseline|Total|Total of all reporting groups
695373|NCT00281697|B2|Baseline|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695374|NCT00281697|B1|Baseline|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695375|NCT00281697|P2|Participant Flow|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695376|NCT00281697|P1|Participant Flow|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695377|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695378|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695379|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695380|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695381|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695382|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695587|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695385|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695386|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695387|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695388|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695389|NCT00281697|E2|Reported Event|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
695390|NCT00281697|E1|Reported Event|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
695391|NCT00281658|B3|Baseline|Total|Total of all reporting groups
695392|NCT00281658|B2|Baseline|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695393|NCT00281658|B1|Baseline|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695394|NCT00281658|P3|Participant Flow|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily
695395|NCT00281658|P2|Participant Flow|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695396|NCT00281658|P1|Participant Flow|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695397|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695398|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695399|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695400|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695401|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695402|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695403|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695404|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695405|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695406|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695407|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695408|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695409|NCT00281658|E3|Reported Event|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily. This is not a comparative treatment arm.
695410|NCT00281658|E2|Reported Event|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
695411|NCT00281658|E1|Reported Event|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
695412|NCT00281632|B1|Baseline|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695413|NCT00281632|P1|Participant Flow|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695414|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695415|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695416|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695417|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695418|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695419|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695420|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695421|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695422|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695423|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695432|NCT00281632|O1|Outcome|Pazopanib 800 mg With Measurable Disease|Participants with measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily
695433|NCT00281632|O1|Outcome|Overall Study Arm|
695434|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695435|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695436|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695437|NCT00281632|E1|Reported Event|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
695438|NCT00281580|B17|Baseline|Total|Total of all reporting groups
695439|NCT00281580|B16|Baseline|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695440|NCT00281580|B15|Baseline|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695441|NCT00281580|B14|Baseline|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695442|NCT00281580|B13|Baseline|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695443|NCT00281580|B12|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695444|NCT00281580|B11|Baseline|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695445|NCT00281580|B10|Baseline|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695446|NCT00281580|B9|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695447|NCT00281580|B8|Baseline|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695448|NCT00281580|B7|Baseline|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695449|NCT00281580|B6|Baseline|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695450|NCT00281580|B5|Baseline|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695451|NCT00281580|B4|Baseline|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695452|NCT00281580|B3|Baseline|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695453|NCT00281580|B2|Baseline|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695454|NCT00281580|B1|Baseline|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695455|NCT00281580|P16|Participant Flow|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695456|NCT00281580|P15|Participant Flow|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695457|NCT00281580|P14|Participant Flow|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695458|NCT00281580|P13|Participant Flow|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695459|NCT00281580|P12|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695460|NCT00281580|P11|Participant Flow|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695461|NCT00281580|P10|Participant Flow|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695462|NCT00281580|P9|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695463|NCT00281580|P8|Participant Flow|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695464|NCT00281580|P7|Participant Flow|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695465|NCT00281580|P6|Participant Flow|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695466|NCT00281580|P5|Participant Flow|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695467|NCT00281580|P4|Participant Flow|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695468|NCT00281580|P3|Participant Flow|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695469|NCT00281580|P2|Participant Flow|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695470|NCT00281580|P1|Participant Flow|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695471|NCT00281580|O4|Outcome|Combination Therapy|Telmisartan 20/40/80mg tablet plus 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
695472|NCT00281580|O3|Outcome|Amlodipine Monotherapy|encapsulated Amlodipine 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
695473|NCT00281580|O2|Outcome|Telmisartan Monotherapy|Telmisartan 20/40/80mg tablet, QD in morning
695474|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695475|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695476|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695477|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695478|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695479|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695480|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695481|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695482|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695483|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695588|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695484|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695485|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695486|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695487|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695488|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695489|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695490|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695491|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695492|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695493|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695494|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695495|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695496|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695497|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695498|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695499|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695500|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695501|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695502|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695503|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695504|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695505|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695506|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695507|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695508|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695509|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695510|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695511|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695512|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695513|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695514|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695515|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695516|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695517|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695518|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695519|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695520|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695521|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695522|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695523|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695524|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695525|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695526|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695527|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695528|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695529|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695530|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695531|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695532|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695533|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695534|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695535|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695536|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695537|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695538|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695539|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695540|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695541|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695542|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695543|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695544|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695545|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
695546|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695547|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695548|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695549|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695550|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695551|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695552|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695553|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695554|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695555|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695556|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695557|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695558|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695559|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695560|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695561|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695562|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695563|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695564|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695565|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695566|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695567|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695568|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695569|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695570|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695571|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695572|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695573|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695574|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695575|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695576|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695577|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695578|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695579|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695580|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695581|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695582|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695583|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695584|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695585|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695586|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
703689|NCT00253890|P1|Participant Flow|Trazodone|50-150mg at bedtime
695590|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695591|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695592|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695593|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695594|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695595|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695596|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695597|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695598|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695599|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695600|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695601|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695602|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695603|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695604|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695605|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695606|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695607|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695608|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695609|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695610|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695611|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695612|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695613|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695614|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695615|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695616|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695617|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695618|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695619|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695620|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695621|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695622|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
695623|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
695624|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
695625|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
695626|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
695627|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
695628|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
695629|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
695630|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
695631|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695632|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695633|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695634|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
695635|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
695636|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
695637|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
695638|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695639|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695640|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695641|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695642|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695643|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695644|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695645|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695646|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695647|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695648|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695649|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695650|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695651|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695652|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695653|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695654|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695655|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695656|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695657|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695658|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695659|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695660|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695661|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695662|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695663|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695664|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695665|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695666|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695667|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695668|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695669|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695670|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695671|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695672|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695673|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695674|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695675|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695676|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695677|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695678|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695679|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695680|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695681|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695682|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695683|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695684|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695685|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695686|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695687|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695688|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695689|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695690|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695691|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695692|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695693|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695694|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695695|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695696|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695697|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695698|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695699|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695700|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695701|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695702|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695703|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695704|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695705|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695706|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695707|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695708|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695709|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695710|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695711|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695712|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695713|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695714|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695715|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695716|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695717|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695718|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695719|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695720|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695721|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695722|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695723|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695724|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695725|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695726|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695727|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695728|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695729|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695730|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695731|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695732|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695733|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695734|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695735|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695736|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695737|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695738|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695739|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695740|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695741|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695742|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695743|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695744|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695745|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695746|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
703690|NCT00253890|O2|Outcome|Placebo|1-3 capsules at bedtime
695747|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695748|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695749|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695750|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695751|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695752|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695753|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695754|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695755|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695756|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695757|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695758|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695759|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695760|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695761|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695762|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695763|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695764|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695765|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
695766|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695767|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695768|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
695769|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
695770|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
695771|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
695772|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
695773|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
695774|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
695775|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
695776|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
695777|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
695778|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
695779|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
695780|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695781|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
695782|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695783|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695784|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695785|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
695786|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
695787|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
695788|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
695789|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
695790|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
695791|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
695792|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
695793|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
695794|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
695795|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
695796|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
695797|NCT00281580|E16|Reported Event|Amlodipine 10 mg (A10)|
695798|NCT00281580|E15|Reported Event|Amlodipine 5 mg (A5)|
695799|NCT00281580|E14|Reported Event|Amlodipine 2.5 mg (A2.5)|
695800|NCT00281580|E13|Reported Event|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|
695801|NCT00281580|E12|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|
695802|NCT00281580|E11|Reported Event|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|
695803|NCT00281580|E10|Reported Event|Telmisartan 80 mg (T80)|
695804|NCT00281580|E9|Reported Event|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|
695805|NCT00281580|E8|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|
695806|NCT00281580|E7|Reported Event|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|
695807|NCT00281580|E6|Reported Event|Telmisartan 40 mg (T40)|
695808|NCT00281580|E5|Reported Event|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|
695809|NCT00281580|E4|Reported Event|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|
695810|NCT00281580|E3|Reported Event|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|
695811|NCT00281580|E2|Reported Event|Telmisartan 20 mg (T20)|
695812|NCT00281580|E1|Reported Event|PLACEBO|
695813|NCT00281528|B4|Baseline|Total|Total of all reporting groups
695814|NCT00281528|B3|Baseline|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695815|NCT00281528|B2|Baseline|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695816|NCT00281528|B1|Baseline|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695817|NCT00281528|P3|Participant Flow|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695818|NCT00281528|P2|Participant Flow|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695819|NCT00281528|P1|Participant Flow|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695820|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695821|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695822|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695823|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695824|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695825|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695826|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695827|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695828|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695829|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695830|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695831|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695832|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695833|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695834|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695835|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695836|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695837|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695838|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695839|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695840|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695841|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695842|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695843|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695844|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695845|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695846|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695847|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695848|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695849|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695850|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695851|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695852|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695853|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695854|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695855|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695856|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
696440|NCT00279201|E3|Reported Event|Lispro Mid Mix Prior Lispro LM Addendum|
695857|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695858|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695859|NCT00281528|E3|Reported Event|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
695860|NCT00281528|E2|Reported Event|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
695861|NCT00281528|E1|Reported Event|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
695862|NCT00281463|B1|Baseline|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
695863|NCT00281463|P1|Participant Flow|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
695864|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
695865|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
695866|NCT00281463|E1|Reported Event|Pushrim Activated Power Assist Wheelchair|"Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
695867|NCT00281320|B3|Baseline|Total|Total of all reporting groups
695868|NCT00281320|B2|Baseline|Asenapine 5-10 mg BID|Asenapine 5 mg twice daily (BID) on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
695869|NCT00281320|B1|Baseline|Asenapine 2-10 mg BID|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
695870|NCT00281320|P2|Participant Flow|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
695871|NCT00281320|P1|Participant Flow|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
695872|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
695873|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
695874|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
695875|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
695876|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameters of asepanine for Day 8.
695877|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameters of asepanine for Day 4.
695878|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
695879|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
695880|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
695881|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
695882|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
695883|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
695884|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
695885|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
695886|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
695887|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
695888|NCT00281320|E2|Reported Event|Asenapine 5-10mg BID|
695889|NCT00281320|E1|Reported Event|Asenapine 2-10mg BID|
695890|NCT00281099|B3|Baseline|Total|Total of all reporting groups
695891|NCT00281099|B2|Baseline|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695892|NCT00281099|B1|Baseline|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
695893|NCT00281099|P2|Participant Flow|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695894|NCT00281099|P1|Participant Flow|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
695895|NCT00281099|O1|Outcome|All Screened Patients|All Patients Screened for Possible Enrollment
695896|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695897|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695898|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695899|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695900|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695901|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695902|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695903|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695904|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695905|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695906|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695907|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695908|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695909|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695910|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695911|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695912|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695913|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695914|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695915|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695916|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695917|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695918|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695919|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695920|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695921|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695922|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695923|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695924|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695925|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695926|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695927|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695928|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695929|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695930|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695931|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
695932|NCT00281099|E2|Reported Event|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
695933|NCT00281099|E1|Reported Event|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
695934|NCT00281021|B1|Baseline|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
695935|NCT00281021|P1|Participant Flow|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
695936|NCT00281021|O1|Outcome|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
695937|NCT00281021|E1|Reported Event|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
695938|NCT00280917|B5|Baseline|Total|Total of all reporting groups
695939|NCT00280917|B4|Baseline|Placebo|Matching Placebo q12 hours for 12 weeks
695940|NCT00280917|B3|Baseline|CF101 4mg|CF101 4 mg q12 hours for 12 weeks
695941|NCT00280917|B2|Baseline|CF101 1mg|CF101 1 mg q12 hours for 12 weeks
695942|NCT00280917|B1|Baseline|CF101 0.1mg|CF101 0.1 mg q12 hours for 12 weeks
695943|NCT00280917|P4|Participant Flow|Placebo|Matching placebo q12 hours orally
695944|NCT00280917|P3|Participant Flow|CF101 4mg|CF101 4mg q12 hours orally
695945|NCT00280917|P2|Participant Flow|CF101 1mg|CF101 1mg q12 hours orally
695946|NCT00280917|P1|Participant Flow|CF101 0.1mg|CF101 0.1 mg q12 hours orally
695947|NCT00280917|O4|Outcome|Placebo|Matching placebo q12 hours for 12 weeks
695948|NCT00280917|O3|Outcome|CF101 4 mg|CF101 4 mg q12 hours for 12 weeks
695949|NCT00280917|O2|Outcome|CF101 1 mg|CF101 1 mg q12 hours for 12 weeks
695950|NCT00280917|O1|Outcome|CF101 0.1 mg|CF101 0.1 mg q12 hours for 12 weeks
695951|NCT00280917|E4|Reported Event|Placebo|Matching placebo
695952|NCT00280917|E3|Reported Event|CF101 4mg|CF101 4 mg given orally q12h for 12 weeks
695953|NCT00280917|E2|Reported Event|CF101 1mg|CF101 1 mg given orally q12h for 12 weeks
695954|NCT00280917|E1|Reported Event|CF101 0.1mg|CF101 0.1 mg given orally q12h for 12 weeks
695955|NCT00280904|B1|Baseline|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
696441|NCT00279201|E2|Reported Event|Lispro LM Initiation|
695956|NCT00280904|P1|Participant Flow|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
695957|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated (AI) or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
695958|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
695959|NCT00280904|E1|Reported Event|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
695960|NCT00280826|B1|Baseline|Efalizumab|Treatment of cystoid macular edema due to uveitis
695961|NCT00280826|P1|Participant Flow|Efalizumab|Treatment of cystoid macular edema due to uveitis
695962|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
695963|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
695964|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
695965|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
695966|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
695967|NCT00280826|E1|Reported Event|Efalizumab|Treatment of cystoid macular edema due to uveitis
695968|NCT00280748|B1|Baseline|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695969|NCT00280748|P1|Participant Flow|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695970|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695971|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695972|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695973|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695974|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695975|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695976|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695977|NCT00280748|E1|Reported Event|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
695978|NCT00280735|B1|Baseline|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
695979|NCT00280735|P1|Participant Flow|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
695980|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
695981|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
695982|NCT00280735|O3|Outcome|Grade 3/4 %|Percentage of patients receiving treatment who developed this toxicity
695983|NCT00280735|O2|Outcome|Grade 4 %|Percentage of patients receiving treatment who developed this toxicity
695984|NCT00280735|O1|Outcome|Grade 3 %|Percentage of patients receiving treatment who developed this toxicity
695985|NCT00280735|O1|Outcome|Single Arm Trial|Patients who relapsed
695986|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
695987|NCT00280735|E1|Reported Event|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
695988|NCT00280683|B3|Baseline|Total|Total of all reporting groups
695989|NCT00280683|B2|Baseline|Placebo|Placebo intervention
695990|NCT00280683|B1|Baseline|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
695991|NCT00280683|P2|Participant Flow|Placebo|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
695992|NCT00280683|P1|Participant Flow|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
695993|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were disbursed by the Investigational Drug Service.
695994|NCT00280683|O1|Outcome|Arginine|L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
695995|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were made by Jarrow Formulas.
695996|NCT00280683|O1|Outcome|Arginine|The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.
695997|NCT00280683|E2|Reported Event|Placebo|Matching placebo tablets were purchased from Jarrow Formulas.
695998|NCT00280683|E1|Reported Event|Arginine|L-arginine 1 g tablets were made by Jarrow Formulas.
695999|NCT00280566|B3|Baseline|Total|Total of all reporting groups
696000|NCT00280566|B2|Baseline|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
696001|NCT00280566|B1|Baseline|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
696002|NCT00280566|P3|Participant Flow|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
696003|NCT00280566|P2|Participant Flow|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
696004|NCT00280566|P1|Participant Flow|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
696005|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696006|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696007|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696008|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696009|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696010|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696011|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696012|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696013|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696014|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696015|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696016|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696017|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696018|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696019|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696020|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696021|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696022|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696023|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
696024|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
696025|NCT00280566|E3|Reported Event|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
696026|NCT00280566|E2|Reported Event|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
696027|NCT00280566|E1|Reported Event|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
696028|NCT00280397|B1|Baseline|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
696029|NCT00280397|P1|Participant Flow|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
696030|NCT00280397|O2|Outcome|E7080 - 20 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
696031|NCT00280397|O1|Outcome|E7080 - 16 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
696032|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
696033|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
696034|NCT00280397|E1|Reported Event|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
696035|NCT00280384|B9|Baseline|Total|Total of all reporting groups
696036|NCT00280384|B8|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696037|NCT00280384|B7|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696038|NCT00280384|B6|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696039|NCT00280384|B5|Baseline|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696040|NCT00280384|B4|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696041|NCT00280384|B3|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696042|NCT00280384|B2|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696043|NCT00280384|B1|Baseline|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696044|NCT00280384|P8|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696045|NCT00280384|P7|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696046|NCT00280384|P6|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696047|NCT00280384|P5|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696048|NCT00280384|P4|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696049|NCT00280384|P3|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696050|NCT00280384|P2|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696051|NCT00280384|P1|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696052|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696053|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696054|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696055|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696056|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696057|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696058|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696272|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696059|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696060|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696061|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696062|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696063|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696064|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696065|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696066|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696067|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696068|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696069|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696070|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696071|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696072|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696073|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696074|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696075|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696076|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696077|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696078|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696079|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696080|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696081|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696082|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696083|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696084|NCT00280384|E8|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696085|NCT00280384|E7|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696086|NCT00280384|E6|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696273|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696442|NCT00279201|E1|Reported Event|Insulin Glargine Initiation|
696087|NCT00280384|E5|Reported Event|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
696088|NCT00280384|E4|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696089|NCT00280384|E3|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696090|NCT00280384|E2|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696091|NCT00280384|E1|Reported Event|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
696092|NCT00280293|B3|Baseline|Total|Total of all reporting groups
696093|NCT00280293|B2|Baseline|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696094|NCT00280293|B1|Baseline|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696095|NCT00280293|P2|Participant Flow|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696096|NCT00280293|P1|Participant Flow|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696097|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696098|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696099|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696100|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696101|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696102|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696103|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696104|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696105|NCT00280293|E2|Reported Event|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696106|NCT00280293|E1|Reported Event|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
696107|NCT00280241|B1|Baseline|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
696274|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696443|NCT00278993|B1|Baseline|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696108|NCT00280241|P1|Participant Flow|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
696109|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
696110|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
696111|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
696112|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
696113|NCT00280241|E1|Reported Event|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
696114|NCT00280150|B5|Baseline|Total|Total of all reporting groups
696115|NCT00280150|B4|Baseline|Phase II|Bevacizumab + Erlotinib100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
696116|NCT00280150|B3|Baseline|Cohort 3|Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
696117|NCT00280150|B2|Baseline|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
696118|NCT00280150|B1|Baseline|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
696119|NCT00280150|P4|Participant Flow|Phase II|Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
696120|NCT00280150|P3|Participant Flow|Cohort 3|Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
696121|NCT00280150|P2|Participant Flow|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
696122|NCT00280150|P1|Participant Flow|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy
696123|NCT00280150|O1|Outcome|Overall Study|This includes patients from all cohorts.
696124|NCT00280150|O1|Outcome|Overall Study|All 45 patients were included in the summary of efficacy outcomes.
696125|NCT00280150|O1|Outcome|Overall Study|This includes patients from all cohorts.
696126|NCT00280150|O1|Outcome|Overall Study|This includes patients from all cohorts.
696127|NCT00280150|O2|Outcome|Concurrent Therapy|Percentage of all patients receiving concurrent therapy
696128|NCT00280150|O1|Outcome|Induction Therapy|Percentage of all patients receiving induction therapy
696129|NCT00280150|O4|Outcome|Phase II|Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
696130|NCT00280150|O3|Outcome|Cohort 3|Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
696131|NCT00280150|O2|Outcome|Cohort 2|Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
696132|NCT00280150|O1|Outcome|Cohort 1|Bevacizumab 10 mg + Chemoradiotherapy
696133|NCT00280150|E1|Reported Event|Overall Study|Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. This includes patients from all cohorts.
696134|NCT00280059|B3|Baseline|Total|Total of all reporting groups
696135|NCT00280059|B2|Baseline|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696136|NCT00280059|B1|Baseline|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696137|NCT00280059|P2|Participant Flow|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696275|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696276|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696138|NCT00280059|P1|Participant Flow|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696139|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696140|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696141|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696142|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696143|NCT00280059|O8|Outcome|Lamotrigine 500 mg/Day|Lamotrigine 500 mg/day administered BID
696144|NCT00280059|O7|Outcome|Lamotrigine 400 mg/Day|Lamotrigine 400 mg/day administered BID
696145|NCT00280059|O6|Outcome|Lamotrigine 200 mg/Day|Lamotrigine 200 mg/day administered BID
696146|NCT00280059|O5|Outcome|Lamotrigine 100 mg/Day|Lamotrigine 100 mg/day administered BID
696147|NCT00280059|O4|Outcome|Pregabalin 600 mg/Day|Pregabalin 600 mg/day administered BID
696148|NCT00280059|O3|Outcome|Pregabalin 450 mg/Day|Pregabalin 450 mg/day administered BID
696149|NCT00280059|O2|Outcome|Pregabalin 300 mg/Day|Pregabalin 300 mg/day administered BID
696150|NCT00280059|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 150 mg/day administered twice daily (BID)
696151|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696152|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696153|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696154|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696155|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696156|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696157|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696158|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696159|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696160|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696161|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696162|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
703691|NCT00253890|O1|Outcome|Trazodone|50-150mg at bedtime
696163|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696164|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696165|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696166|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696167|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696168|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696169|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696170|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696171|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696172|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696173|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696174|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696175|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696176|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696177|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696178|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696179|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696180|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696181|NCT00280059|E2|Reported Event|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696277|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
703692|NCT00253890|E2|Reported Event|Placebo|1-3 at bedtime
696182|NCT00280059|E1|Reported Event|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
696183|NCT00279955|B4|Baseline|Total|Total of all reporting groups
696184|NCT00279955|B3|Baseline|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
696185|NCT00279955|B2|Baseline|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696186|NCT00279955|B1|Baseline|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696187|NCT00279955|P3|Participant Flow|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
696188|NCT00279955|P2|Participant Flow|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696189|NCT00279955|P1|Participant Flow|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696190|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696191|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696192|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696193|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696194|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696195|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696196|NCT00279955|E3|Reported Event|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
696197|NCT00279955|E2|Reported Event|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696198|NCT00279955|E1|Reported Event|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
696199|NCT00279916|B3|Baseline|Total|Total of all reporting groups
696200|NCT00279916|B2|Baseline|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696201|NCT00279916|B1|Baseline|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696202|NCT00279916|P2|Participant Flow|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696203|NCT00279916|P1|Participant Flow|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696204|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696205|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696206|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696207|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696208|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696209|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696210|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696211|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696212|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696213|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696214|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696215|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696216|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696217|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696218|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696219|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696220|NCT00279916|E2|Reported Event|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
696221|NCT00279916|E1|Reported Event|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
696222|NCT00279708|B3|Baseline|Total|Total of all reporting groups
696223|NCT00279708|B2|Baseline|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
696224|NCT00279708|B1|Baseline|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
696225|NCT00279708|P2|Participant Flow|Control Group (Placebo)|Placebo In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
696278|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696279|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696226|NCT00279708|P1|Participant Flow|Intervention Group (Atorvastatin)|Atorvastatin Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
696227|NCT00279708|O2|Outcome|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study: Placebo vs. Atorvastatin
696228|NCT00279708|O1|Outcome|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
696229|NCT00279708|E2|Reported Event|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
696230|NCT00279708|E1|Reported Event|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
696231|NCT00279591|B3|Baseline|Total|Total of all reporting groups
696232|NCT00279591|B2|Baseline|Intervention Group|Near Continuous Blood Pressure Monitoring
696233|NCT00279591|B1|Baseline|Control Group|Oscillometric Blood Pressure Monitoring
696234|NCT00279591|P2|Participant Flow|Intervention Group|Near Continuous Blood Pressure Monitoring
696235|NCT00279591|P1|Participant Flow|Control Group|Oscillometric Blood Pressure Monitoring
696236|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
696237|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
696238|NCT00279591|O2|Outcome|Control Group|
696239|NCT00279591|O1|Outcome|Intervention Group|
696240|NCT00279591|O2|Outcome|Control Group|
696241|NCT00279591|O1|Outcome|Intervention Group|
696242|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
696243|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
696244|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
696245|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
696246|NCT00279591|E2|Reported Event|Intervention Group|Near Continuous Blood Pressure Monitoring
696247|NCT00279591|E1|Reported Event|Control Group|Oscillometric Blood Pressure Monitoring
696248|NCT00279500|B1|Baseline|Treatment Arm|Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
696249|NCT00279500|P1|Participant Flow|Argus 16 Retinal Stimulation System|Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
696250|NCT00279500|O1|Outcome|Argus 16 Retinal Stimulation System|Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
696251|NCT00279500|E1|Reported Event|Argus 16 Retinal Stimulation System|Single arm study in which all patients receive a device to stimulate retinal (eye) cells. The treatment is intended to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
696252|NCT00279305|B3|Baseline|Total|Total of all reporting groups
696253|NCT00279305|B2|Baseline|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
696254|NCT00279305|B1|Baseline|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
696255|NCT00279305|P2|Participant Flow|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
696256|NCT00279305|P1|Participant Flow|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
696257|NCT00279305|O2|Outcome|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
696258|NCT00279305|O1|Outcome|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
696259|NCT00279305|E2|Reported Event|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
696260|NCT00279305|E1|Reported Event|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
696261|NCT00279214|B3|Baseline|Total|Total of all reporting groups
696262|NCT00279214|B2|Baseline|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696263|NCT00279214|B1|Baseline|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696264|NCT00279214|P2|Participant Flow|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696265|NCT00279214|P1|Participant Flow|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696266|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696267|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696268|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696269|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696270|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696271|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696433|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696280|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696281|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696282|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696283|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696284|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696285|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696286|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696287|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696288|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696289|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696290|NCT00279214|E2|Reported Event|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
696291|NCT00279214|E1|Reported Event|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
696292|NCT00279201|B3|Baseline|Total|Total of all reporting groups
696293|NCT00279201|B2|Baseline|Lispro LM|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696294|NCT00279201|B1|Baseline|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696295|NCT00279201|P6|Participant Flow|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696296|NCT00279201|P5|Participant Flow|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696297|NCT00279201|P4|Participant Flow|Lispro Low Mix Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
696298|NCT00279201|P3|Participant Flow|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696299|NCT00279201|P2|Participant Flow|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696300|NCT00279201|P1|Participant Flow|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696301|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696302|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696303|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
696304|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696305|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696306|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696307|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696308|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696309|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696310|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696311|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
696312|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696313|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696314|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696315|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696316|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696317|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696318|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696319|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696320|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696321|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696322|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696323|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696324|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696325|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696326|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696327|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696328|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696329|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696330|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696331|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696332|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696434|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696333|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696334|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696335|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
696336|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696337|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696338|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696339|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
696340|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696341|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
696342|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
696343|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
696344|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
696345|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
696346|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
696347|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
696348|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
696349|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
696350|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
696351|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
696352|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
696353|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
696354|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
696355|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
696356|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
696357|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
696358|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
696359|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
696360|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
696361|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
696362|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
696363|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
696364|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
696365|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
696366|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
696367|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
696368|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
696369|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696370|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696371|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696372|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696373|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696374|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696375|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696376|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696377|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696435|NCT00279201|E8|Reported Event|Lispro LM Maintenance|
696436|NCT00279201|E7|Reported Event|Insulin Glargine Maintenance|
696378|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696379|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696380|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696381|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696382|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696383|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696384|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696385|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696386|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696387|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696388|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696389|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696390|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696391|NCT00279201|O2|Outcome|Did Not Meet Goal|
696392|NCT00279201|O1|Outcome|Met Goal|
696393|NCT00279201|O2|Outcome|Did Not Meet Goal|
696394|NCT00279201|O1|Outcome|Met Goal|
696395|NCT00279201|O2|Outcome|Did Not Meet Goal|
696396|NCT00279201|O1|Outcome|Met Goal|
696397|NCT00279201|O2|Outcome|Did Not Meet Goal|
696398|NCT00279201|O1|Outcome|Met Goal|
696399|NCT00279201|O2|Outcome|Did Not Meet Goal|
696400|NCT00279201|O1|Outcome|Met Goal|
696401|NCT00279201|O2|Outcome|Did Not Meet Goal|
696402|NCT00279201|O1|Outcome|Met Goal|
696403|NCT00279201|O2|Outcome|Did Not Meet Goal|
696404|NCT00279201|O1|Outcome|Met Goal|
696405|NCT00279201|O2|Outcome|Did Not Meet Goal|
696406|NCT00279201|O1|Outcome|Met Goal|
696407|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696408|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696409|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696410|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696411|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696412|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696413|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696414|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696415|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696416|NCT00279201|O1|Outcome|Insulin Gargine|Insulin glargine for 24 weeks.
696417|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696418|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696419|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696420|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696421|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696422|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696423|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696424|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696425|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
696426|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
696427|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696428|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
696429|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
696430|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
696431|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
696432|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
696444|NCT00278993|P1|Participant Flow|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696445|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696446|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696447|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696448|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696449|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696450|NCT00278993|E1|Reported Event|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
696451|NCT00278954|B1|Baseline|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696452|NCT00278954|P1|Participant Flow|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696453|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696454|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696455|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696456|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696457|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696458|NCT00278954|E1|Reported Event|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
696459|NCT00278915|B1|Baseline|Fulvestrant|Fulvestrant (4 mg / kg)
696460|NCT00278915|P1|Participant Flow|Fulvestrant|Fulvestrant (4 mg / kg)
696461|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696462|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696463|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696464|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696465|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696466|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696467|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696468|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696469|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696470|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696471|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696472|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696473|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696474|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696475|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696476|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696477|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696478|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696479|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696480|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696481|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696482|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696483|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696484|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696485|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696486|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696487|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696488|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696489|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696490|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
696491|NCT00278915|E1|Reported Event|Fulvestrant|Fulvestrant (4 mg / kg)
696492|NCT00278889|B4|Baseline|Total|Total of all reporting groups
696493|NCT00278889|B3|Baseline|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696494|NCT00278889|B2|Baseline|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696495|NCT00278889|B1|Baseline|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696496|NCT00278889|P3|Participant Flow|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696497|NCT00278889|P2|Participant Flow|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696498|NCT00278889|P1|Participant Flow|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696499|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696500|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696501|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696502|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696503|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696504|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696505|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696506|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696507|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696508|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696509|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696510|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696511|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696512|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696513|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696514|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696515|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696516|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696517|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696518|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696519|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696520|NCT00278889|E3|Reported Event|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
696521|NCT00278889|E2|Reported Event|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
696522|NCT00278889|E1|Reported Event|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
696523|NCT00278876|B1|Baseline|Imatinib Mesylate|patients receiving adjuvant imatinib mesylate
696524|NCT00278876|P1|Participant Flow|Imatinib Mesylate|imatinib mesylate 400 mg daily for 2 years
696525|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
696526|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
696527|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
696528|NCT00278876|E1|Reported Event|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
696529|NCT00278863|B3|Baseline|Total|Total of all reporting groups
696530|NCT00278863|B2|Baseline|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
696531|NCT00278863|B1|Baseline|S-1 for 2 Weeks on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
696532|NCT00278863|P2|Participant Flow|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
696533|NCT00278863|P1|Participant Flow|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
696534|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
696535|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
696536|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
696537|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
696538|NCT00278863|E2|Reported Event|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
696539|NCT00278863|E1|Reported Event|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
696540|NCT00278655|B1|Baseline|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
696541|NCT00278655|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and granulocyte colony-stimulating factor (G-CSF) (5-10mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
696542|NCT00278655|O1|Outcome|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and G-CSF (5-10 mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
696543|NCT00278655|O1|Outcome|Stem Cell Transplantation|Autologous hematopoietic stem cell transplantation Peripheral blood stem cells were mobilised with 2g per square m intravenous (IV) cyclophosphamide (CY) followed by 10 µg per kg subcutaneous filgrastim daily from day 5. After neutrophil recovery, the mobilised cells were collected by apheresis. The recovered cells were unselected and cryopreserved. There was at least three weeks between mobilisation and the conditioning regimen. The conditioning regimen used was 200 mg per kg intravenous CY , given in four equal fractions between day -5 and day -2 with IV mesna, and one 20mg dose of IV alemtuzumab (CAMPATH-1H) given on day -2 with 250 mg intravenous methyl-prednisolone as premedication. Alemtuzumab was changed to rabbit antithymocyte globulin rATG) in the last 4 patients, who received 6 mg per kg rATG over 5 days instead of alemtuzumab . Stem cells wer reinfused 36 h after completion of CY. 5 µg/kg/day filgrastim was given from day 5 until neutrophil recovery.
696544|NCT00278655|E1|Reported Event|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
696545|NCT00278525|B3|Baseline|Total|Total of all reporting groups
696546|NCT00278525|B2|Baseline|Standard of Care|medication as standard of care will be given
696547|NCT00278525|B1|Baseline|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
696626|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
696548|NCT00278525|P2|Participant Flow|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
696549|NCT00278525|P1|Participant Flow|Standard of Care|Cyclophosphamide will be given as approved immunosuppressive therapy
696550|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
696551|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
696552|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
696553|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
696554|NCT00278525|E2|Reported Event|Standard of Care|medication as standard of care will be given
696555|NCT00278525|E1|Reported Event|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
696556|NCT00278473|B3|Baseline|Total|Total of all reporting groups
696557|NCT00278473|B2|Baseline|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696558|NCT00278473|B1|Baseline|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696559|NCT00278473|P2|Participant Flow|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696560|NCT00278473|P1|Participant Flow|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696561|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696562|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696563|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696564|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696565|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696566|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696567|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696568|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696569|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696570|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696571|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696572|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696573|NCT00278473|E2|Reported Event|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696574|NCT00278473|E1|Reported Event|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
696575|NCT00278395|B1|Baseline|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
696576|NCT00278395|P1|Participant Flow|Vorinostat|The oral dose of vorinostat capsules was 300 mg two times a day for 3 consecutive days every week for 4 weeks, which constitutes on cycle of treatment. Treatment will be administered on an outpatient basis.
696577|NCT00278395|O1|Outcome|Safety and Tolerability|No participants measured
696578|NCT00278395|O1|Outcome|Overall Survival (OS) and Median OS|No measurement reported
696579|NCT00278395|O1|Outcome|Progression Free Survival|No measurement reported
696580|NCT00278395|O1|Outcome|Vorinostat|The dose of Vorinostat was 300 mg BID on the first 3 days of every week on a 4-week cycle. Dose reduction was allowed for adverse events (AE). Treatment was planned until disease progression (PD), death, unacceptable toxicity, or consent withdrawal.
696581|NCT00278395|E1|Reported Event|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
696582|NCT00278343|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
696583|NCT00278343|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
696584|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: 30mg given PO, daily"
696585|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
696586|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
696587|NCT00278343|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
696588|NCT00278343|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO~laboratory biomarker analysis: Correlative studies"
696589|NCT00277524|B1|Baseline|Overall|All patients enrolled in OMNI.
696590|NCT00277524|P4|Participant Flow|Subjects With CRT-D|Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
696591|NCT00277524|P3|Participant Flow|Subjects With Dual Chamber ICD|Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD).
696592|NCT00277524|P2|Participant Flow|Subjects With Single Chamber ICD|Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD).
696593|NCT00277524|P1|Participant Flow|Subjects With IPG|Subjects implanted with an implantable pulse generator (IPG).
696594|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy-Defibrillator (ICD/CRT-D).
696595|NCT00277524|O4|Outcome|48-month Follow-up|Total subjects with disease progressed at 48 months
696596|NCT00277524|O3|Outcome|36-month Follow-up|Total subjects with disease progressed at 36 months
696597|NCT00277524|O2|Outcome|24-month Follow-up|Total subjects with disease progressed at 24 months
696598|NCT00277524|O1|Outcome|12-month Follow-up|Total subjects with disease progressed at 12 months
696599|NCT00277524|O2|Outcome|"SCD-HeFT Programming"|OMNI “SCD-HeFT” definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms.
696600|NCT00277524|O1|Outcome|"PainFREE Programming"|OMNI “PainFREE” definition: programming combinations that result in ATP therapy for VT at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.
696601|NCT00277524|O1|Outcome|ATP During Charging|Patients who had an episode and were programmed with the ATP during charging feature.
696602|NCT00277524|O2|Outcome|Patients With History of AV Block|Patients with MVP enabled and follow up data available
696603|NCT00277524|O1|Outcome|Patients Without History of AV Block|Patients with MVP enabled and follow up data available
696604|NCT00277524|O2|Outcome|ICD (N=1029)|ICD Patients with MVP enabled and follow up data available
696605|NCT00277524|O1|Outcome|IPG (N=610)|IPG Patients with MVP enabled and follow up data available
696606|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with ICD/CRT-D
696607|NCT00277524|O1|Outcome|IPG Group|Subjects implanted with IPG
696608|NCT00277524|O1|Outcome|Implanted Subjects|All patients enrolled in OMNI.
696609|NCT00277524|E1|Reported Event||The Medtronic OMNI Study is a post-market observational study conducted in the United States (US). Adverse events were not collected as a part of the OMNI study. Sites were instructed to report applicable events in the same manner as required for any commercially available device, through the Medical Device Reporting (MDR) process.
696610|NCT00277446|B1|Baseline|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
696611|NCT00277446|P1|Participant Flow|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
696612|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
696613|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
696614|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
696615|NCT00277446|E1|Reported Event|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
696616|NCT00277394|B3|Baseline|Total|Total of all reporting groups
696617|NCT00277394|B2|Baseline|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
696618|NCT00277394|B1|Baseline|Innohep®|innohep® 175 anti-Xa IU/kg once daily
696619|NCT00277394|P2|Participant Flow|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
696620|NCT00277394|P1|Participant Flow|Innohep®|innohep® 175 anti-Xa IU/kg once daily
696621|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
696622|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
696623|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
696624|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
696625|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
703693|NCT00253890|E1|Reported Event|Trazodone|50-150mg at bedtime
696627|NCT00277394|E2|Reported Event|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
696628|NCT00277394|E1|Reported Event|Innohep®|innohep® 175 anti-Xa IU/kg once daily
696629|NCT00277355|B3|Baseline|Total|Total of all reporting groups
696630|NCT00277355|B2|Baseline|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
696631|NCT00277355|B1|Baseline|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
696632|NCT00277355|P2|Participant Flow|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
696633|NCT00277355|P1|Participant Flow|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
696634|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
696635|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
696636|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
696637|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
696638|NCT00277355|E2|Reported Event|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
696639|NCT00277355|E1|Reported Event|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
696640|NCT00277212|B1|Baseline|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
696641|NCT00277212|P3|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696642|NCT00277212|P2|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696643|NCT00277212|P1|Participant Flow|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
696644|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696645|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696646|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696647|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696648|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696649|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696650|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696651|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696652|NCT00277212|O1|Outcome|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
696653|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696654|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696655|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696656|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696657|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696658|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696659|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696660|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696661|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696662|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696663|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696664|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696665|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696666|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696667|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696668|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696669|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696670|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696671|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696672|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696673|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696674|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696675|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696676|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696677|NCT00277212|E3|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
696678|NCT00277212|E2|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
696679|NCT00277212|E1|Reported Event|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
696680|NCT00277095|B1|Baseline|ProACT|Implantable device
696681|NCT00277095|P1|Participant Flow|Implantable Device|ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.
696682|NCT00277095|O1|Outcome|Urine Loss ( in Grams)|24 hour pad weight(in grams) demonstrating 50% reduction in urine loss (in grams)over 18th month
696683|NCT00277095|E1|Reported Event|ProACT|Implantable device
696684|NCT00276861|B1|Baseline|Single Arm|
696685|NCT00276861|P1|Participant Flow|Oxaliplatin + Gemcitabine|
696686|NCT00276861|O1|Outcome|Oxaliplatin + Gemcitabine|
696687|NCT00276861|O1|Outcome|Single Arm|
696688|NCT00276861|E1|Reported Event|Single Arm|
696689|NCT00276614|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
696690|NCT00276614|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
696691|NCT00276614|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
696692|NCT00276614|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
696693|NCT00276549|B1|Baseline|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
696694|NCT00276549|P1|Participant Flow|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
696695|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
696696|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
696697|NCT00276549|E1|Reported Event|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
696698|NCT00276484|B3|Baseline|Total|Total of all reporting groups
696699|NCT00276484|B2|Baseline|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696700|NCT00276484|B1|Baseline|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696701|NCT00276484|P2|Participant Flow|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696702|NCT00276484|P1|Participant Flow|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696703|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696704|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696705|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696706|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696707|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696708|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696709|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696710|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696711|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696712|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696713|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696714|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696715|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696716|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696717|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696718|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696719|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696720|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696721|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696722|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696723|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696724|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696725|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696726|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696727|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696728|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696729|NCT00276484|E2|Reported Event|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
696730|NCT00276484|E1|Reported Event|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
696731|NCT00276458|B3|Baseline|Total|Total of all reporting groups
696732|NCT00276458|B2|Baseline|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696733|NCT00276458|B1|Baseline|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696734|NCT00276458|P2|Participant Flow|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696735|NCT00276458|P1|Participant Flow|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696736|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696737|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696738|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696739|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696740|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696741|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696742|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696743|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696744|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696745|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696746|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696747|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696748|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696749|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696750|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696751|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696752|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696753|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696754|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696755|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696756|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696757|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696758|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696759|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696760|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696761|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696762|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696763|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696764|NCT00276458|E2|Reported Event|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
696765|NCT00276458|E1|Reported Event|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
696766|NCT00276419|B3|Baseline|Total|Total of all reporting groups
696767|NCT00276419|B2|Baseline|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
696768|NCT00276419|B1|Baseline|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
696769|NCT00276419|P2|Participant Flow|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
696770|NCT00276419|P1|Participant Flow|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
696952|NCT00275834|P2|Participant Flow|Zonisamide 200 mg|Dosing of matching placebo was identical.
697994|NCT00271570|P1|Participant Flow|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
696771|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
696772|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
696773|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
696774|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
696775|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
696776|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
696777|NCT00276419|E2|Reported Event|Diclofenac|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
696778|NCT00276419|E1|Reported Event|Placebo|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
696779|NCT00276406|B3|Baseline|Total|Total of all reporting groups
696780|NCT00276406|B2|Baseline|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696781|NCT00276406|B1|Baseline|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696782|NCT00276406|P2|Participant Flow|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696783|NCT00276406|P1|Participant Flow|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696784|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696785|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696786|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696787|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696788|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696789|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696790|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696791|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696792|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696793|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696794|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696795|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696796|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696797|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696798|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696799|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696800|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696801|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696802|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696803|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696804|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696805|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696806|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696807|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696808|NCT00276406|E2|Reported Event|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
696809|NCT00276406|E1|Reported Event|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
696810|NCT00276380|B3|Baseline|Total|Total of all reporting groups
696811|NCT00276380|B2|Baseline|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch"
696812|NCT00276380|B1|Baseline|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696813|NCT00276380|P2|Participant Flow|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696814|NCT00276380|P1|Participant Flow|EGb761®|"Subjects received EGb761® 240 milligrams (mg)/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696815|NCT00276380|O2|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696816|NCT00276380|O1|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696817|NCT00276380|O2|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696818|NCT00276380|O1|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696819|NCT00276380|O2|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696820|NCT00276380|O1|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696821|NCT00276380|O2|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696822|NCT00276380|O1|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696823|NCT00276380|O2|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696824|NCT00276380|O1|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696825|NCT00276380|O2|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696826|NCT00276380|O1|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch"
697019|NCT00275509|P2|Participant Flow|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
696827|NCT00276380|O2|Outcome|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696828|NCT00276380|O1|Outcome|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch"
696829|NCT00276380|E2|Reported Event|Placebo|"Subjects received placebo for 6 months, administered orally, in association with acetylsalicylic acid (325 mg/day).~The placebo consisted of 6 tablets/day. 2 tablets were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch."
696830|NCT00276380|E1|Reported Event|EGb761®|"Subjects received EGb761® 240 mg/day for 6 months administered orally, in association with acetylsalicylic acid (325 mg/day).~The test treatment consisted of 6 tablets/day. 2 tablets (each containing 40 mg EGb761®) were taken orally with half a glass of water during the 3 main meals. Subjects also took 1 tablet/day of acetylsalicylic acid during lunch"
696831|NCT00276250|B4|Baseline|Total|Total of all reporting groups
696832|NCT00276250|B3|Baseline|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696833|NCT00276250|B2|Baseline|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696834|NCT00276250|B1|Baseline|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696835|NCT00276250|P3|Participant Flow|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696836|NCT00276250|P2|Participant Flow|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696837|NCT00276250|P1|Participant Flow|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696838|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696839|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696840|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696841|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696842|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696843|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696844|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696845|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696846|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696847|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696848|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696876|NCT00276094|B3|Baseline|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
703694|NCT00253747|B3|Baseline|Total|Total of all reporting groups
696849|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696850|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696851|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696852|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696853|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696854|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696855|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696856|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696857|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696858|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696859|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696860|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696861|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696862|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696863|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696864|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696865|NCT00276250|E3|Reported Event|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
696866|NCT00276250|E2|Reported Event|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
696867|NCT00276250|E1|Reported Event|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
696868|NCT00276159|B1|Baseline|852A Treatment|Patients receiving at least 12 doses of 852A.
696869|NCT00276159|P1|Participant Flow|852A Treatment|Patients receiving at least 12 doses of 852A.
696870|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
696871|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
696872|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
696873|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
696874|NCT00276159|E1|Reported Event|852A Treatment|Patients receiving at least 12 doses of 852A.
696875|NCT00276094|B4|Baseline|Total|Total of all reporting groups
696946|NCT00276016|E1|Reported Event|Phenylephrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration.
696947|NCT00275834|B4|Baseline|Total|Total of all reporting groups
696877|NCT00276094|B2|Baseline|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696878|NCT00276094|B1|Baseline|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696879|NCT00276094|P3|Participant Flow|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696880|NCT00276094|P2|Participant Flow|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696881|NCT00276094|P1|Participant Flow|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696882|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696883|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696884|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696885|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696886|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696887|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696888|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696889|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696890|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696891|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696892|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696893|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696894|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696895|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696896|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696897|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696898|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696899|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696900|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696901|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696902|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696903|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696904|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696905|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696906|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696907|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696908|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696909|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696910|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696911|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696912|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696913|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696914|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696915|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696916|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696917|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696918|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696919|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696920|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696921|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696922|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696923|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696924|NCT00276094|E3|Reported Event|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696925|NCT00276094|E2|Reported Event|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696926|NCT00276094|E1|Reported Event|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
696927|NCT00276016|B7|Baseline|Total|Total of all reporting groups
696928|NCT00276016|B6|Baseline|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
696929|NCT00276016|B5|Baseline|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
696930|NCT00276016|B4|Baseline|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
696931|NCT00276016|B3|Baseline|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
696932|NCT00276016|B2|Baseline|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
696933|NCT00276016|B1|Baseline|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
696934|NCT00276016|P6|Participant Flow|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
696935|NCT00276016|P5|Participant Flow|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
696936|NCT00276016|P4|Participant Flow|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
696937|NCT00276016|P3|Participant Flow|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
696938|NCT00276016|P2|Participant Flow|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
696939|NCT00276016|P1|Participant Flow|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
696940|NCT00276016|O2|Outcome|Placebo|
696941|NCT00276016|O1|Outcome|Pseudoephedrine|
696942|NCT00276016|O2|Outcome|Phenylephrine|
696943|NCT00276016|O1|Outcome|Placebo|
696944|NCT00276016|E3|Reported Event|Placebo|Placebo: Placebo capsules.
696945|NCT00276016|E2|Reported Event|Pseudoephedrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
696953|NCT00275834|P1|Participant Flow|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
696954|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696955|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
696956|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
696957|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696958|NCT00275834|O2|Outcome|Zonisamide 200 mg|
696959|NCT00275834|O1|Outcome|Placebo|
696960|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696961|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
696962|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
696963|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696964|NCT00275834|O2|Outcome|Zonisamide 200 mg|
696965|NCT00275834|O1|Outcome|Placebo|
696966|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696967|NCT00275834|O2|Outcome|Zonisamide 200 mg|
696968|NCT00275834|O1|Outcome|Placebo|
696969|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696970|NCT00275834|O2|Outcome|Zonisamide 200 mg|
696971|NCT00275834|O1|Outcome|Placebo|
696972|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696973|NCT00275834|O2|Outcome|Zonisamide 200 mg|
696974|NCT00275834|O1|Outcome|Placebo|
696975|NCT00275834|O3|Outcome|Zonisamide 400 mg|
696976|NCT00275834|O2|Outcome|Zonisamide 200 mg|
696977|NCT00275834|O1|Outcome|Placebo|
696978|NCT00275834|E3|Reported Event|Zonisamide 400 mg|
696979|NCT00275834|E2|Reported Event|Zonisamide 200 mg|
696980|NCT00275834|E1|Reported Event|Placebo|
696981|NCT00275821|B4|Baseline|Total|Total of all reporting groups
696982|NCT00275821|B3|Baseline|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696983|NCT00275821|B2|Baseline|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696984|NCT00275821|B1|Baseline|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696985|NCT00275821|P3|Participant Flow|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696986|NCT00275821|P2|Participant Flow|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696987|NCT00275821|P1|Participant Flow|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696988|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
697020|NCT00275509|P1|Participant Flow|Thymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6.
697021|NCT00275509|O2|Outcome|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
696989|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696990|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696991|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696992|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696993|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696994|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696995|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696996|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696997|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696998|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
696999|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
697000|NCT00275821|E3|Reported Event|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
697001|NCT00275821|E2|Reported Event|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
697002|NCT00275821|E1|Reported Event|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
697003|NCT00275561|B3|Baseline|Total|Total of all reporting groups
697004|NCT00275561|B2|Baseline|Placebo|Placebo inhaler swallowed bid for 6 weeks
697005|NCT00275561|B1|Baseline|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
697006|NCT00275561|P2|Participant Flow|Placebo|Placebo inhaler swallowed bid for 6 weeks
697007|NCT00275561|P1|Participant Flow|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
697008|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
697009|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
697010|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
697011|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
697012|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
697013|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
697014|NCT00275561|E2|Reported Event|Placebo|Placebo inhaler swallowed bid for 6 weeks
697015|NCT00275561|E1|Reported Event|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
697016|NCT00275509|B3|Baseline|Total|Total of all reporting groups
697017|NCT00275509|B2|Baseline|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
697018|NCT00275509|B1|Baseline|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
697022|NCT00275509|O1|Outcome|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
697023|NCT00275509|O2|Outcome|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
697024|NCT00275509|O1|Outcome|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
697025|NCT00275509|O2|Outcome|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
697026|NCT00275509|O1|Outcome|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
697027|NCT00275509|E2|Reported Event|Daclizumab|Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
697028|NCT00275509|E1|Reported Event|Tymoglobulin|Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6
697029|NCT00275392|B3|Baseline|Total|Total of all reporting groups
697030|NCT00275392|B2|Baseline|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
697031|NCT00275392|B1|Baseline|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
697032|NCT00275392|P2|Participant Flow|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
697033|NCT00275392|P1|Participant Flow|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
697034|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
697035|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
697036|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
697037|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
697038|NCT00275392|E2|Reported Event|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
697039|NCT00275392|E1|Reported Event|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
697040|NCT00275340|B3|Baseline|Total|Total of all reporting groups
697041|NCT00275340|B2|Baseline|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
697042|NCT00275340|B1|Baseline|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
697043|NCT00275340|P2|Participant Flow|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
697044|NCT00275340|P1|Participant Flow|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
697045|NCT00275340|O2|Outcome|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
697046|NCT00275340|O1|Outcome|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
697047|NCT00275301|B1|Baseline|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
697048|NCT00275301|P1|Participant Flow|All Subjects Took Open-label Olanzapine.|All subjects took open-label olanzapine. Subjects tritrated to up to 10mg
697049|NCT00275301|O1|Outcome|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
697050|NCT00275301|E1|Reported Event|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
697051|NCT00275275|B4|Baseline|Total|Total of all reporting groups
697052|NCT00275275|B3|Baseline|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
697053|NCT00275275|B2|Baseline|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
697054|NCT00275275|B1|Baseline|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
697055|NCT00275275|P3|Participant Flow|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
697056|NCT00275275|P2|Participant Flow|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
697057|NCT00275275|P1|Participant Flow|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
697058|NCT00275275|O2|Outcome|Preferred Mirapex|This is the group that preferred Mirapex to Requip PR
697059|NCT00275275|O1|Outcome|Preferred Requip PR|This is the group of subjects that preferred Requip PR to Mirapex
697060|NCT00275275|O2|Outcome|Preferred Mirapex|This group refers to the subjects that preferred Mirapex
697061|NCT00275275|O1|Outcome|Preferred Requip PR|This group refers to the subjects that preferred Requip PR to Mirapex
697062|NCT00275275|E2|Reported Event|Preferred Mirapex|These are the subjects that preferred Mirapex to Requip PR at the end of the study
697063|NCT00275275|E1|Reported Event|Preferred Requip PR|These are the subjects that preferred Requip PR to Mirapex at the end of the study
697064|NCT00275262|B3|Baseline|Total|Total of all reporting groups
697065|NCT00275262|B2|Baseline|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697066|NCT00275262|B1|Baseline|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697067|NCT00275262|P2|Participant Flow|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697068|NCT00275262|P1|Participant Flow|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697069|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697070|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697071|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697072|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697073|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697074|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697075|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697076|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697077|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697078|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697079|NCT00275262|E2|Reported Event|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
697080|NCT00275262|E1|Reported Event|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
697081|NCT00275028|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
697082|NCT00275028|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
697083|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
697084|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
697085|NCT00275028|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
697086|NCT00275002|B3|Baseline|Total|Total of all reporting groups
697087|NCT00275002|B2|Baseline|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697088|NCT00275002|B1|Baseline|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697089|NCT00275002|P2|Participant Flow|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697090|NCT00275002|P1|Participant Flow|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697091|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697092|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697093|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697094|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697095|NCT00275002|E2|Reported Event|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697096|NCT00275002|E1|Reported Event|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
697097|NCT00274937|B1|Baseline|Stratum II|AJCC Stage IIb - IV
697098|NCT00274937|P1|Participant Flow|Stratum II|AJCC Stage IIb - IV
697099|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
697100|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
697101|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
697102|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
697103|NCT00274937|E1|Reported Event|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.~amifostine trihydrate: Given subcutaneously~fluorouracil: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies~radiation therapy: Undergo radiotherapy"
697104|NCT00274924|B4|Baseline|Total|Total of all reporting groups
697105|NCT00274924|B3|Baseline|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
697106|NCT00274924|B2|Baseline|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
697107|NCT00274924|B1|Baseline|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
697108|NCT00274924|P3|Participant Flow|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
697109|NCT00274924|P2|Participant Flow|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
697110|NCT00274924|P1|Participant Flow|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
697111|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
697112|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
697113|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
697114|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
697115|NCT00274924|E3|Reported Event|Step 2 - Mid-treatment PET Negative|Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
697216|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
697116|NCT00274924|E2|Reported Event|Step 2 - Mid-treatment PET Positive|Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
697117|NCT00274924|E1|Reported Event|Step 1 - All Treated Patients|All treated patients regardless of eligibility.
697118|NCT00274846|B1|Baseline|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
697119|NCT00274846|P1|Participant Flow|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
697120|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
697121|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
697122|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
697123|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
697124|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
697125|NCT00274846|E1|Reported Event|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
697126|NCT00274781|B1|Baseline|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
697127|NCT00274781|P1|Participant Flow|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
697128|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
697129|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
697130|NCT00274781|O1|Outcome|ATO + GO|"Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m^2 D8 for 1 or 2 Cycles of 12 Weeks each~arsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).~gemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion"
697131|NCT00274781|E1|Reported Event|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
697132|NCT00274768|B1|Baseline|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
697133|NCT00274768|P1|Participant Flow|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
697134|NCT00274768|O1|Outcome|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
697135|NCT00274768|E1|Reported Event|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
697136|NCT00274742|B7|Baseline|Total|Total of all reporting groups
697137|NCT00274742|B6|Baseline|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697138|NCT00274742|B5|Baseline|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
697139|NCT00274742|B4|Baseline|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697140|NCT00274742|B3|Baseline|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697141|NCT00274742|B2|Baseline|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697142|NCT00274742|B1|Baseline|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697217|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
697143|NCT00274742|P6|Participant Flow|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697144|NCT00274742|P5|Participant Flow|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
697145|NCT00274742|P4|Participant Flow|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697146|NCT00274742|P3|Participant Flow|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697147|NCT00274742|P2|Participant Flow|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697148|NCT00274742|P1|Participant Flow|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697149|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697150|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
697151|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697152|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697153|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697154|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697155|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697156|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
697157|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697158|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697159|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697160|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697161|NCT00274742|O5|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
697162|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d|Participants received blinatumomab 60 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
697163|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion in hte first treatment cycle.
697164|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants who received blinatumomab 15 µg/m²/day as continuous intravenous infusion in the first treatment cyle.
697165|NCT00274742|O1|Outcome|Blinatumomab 5 µg/m²/d|Participants who received blinatumomab 5 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
697166|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697167|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
697168|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697169|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697170|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697171|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697172|NCT00274742|E7|Reported Event|Blinatumomab Overall|All participants who received any dose of blinatumomab
697173|NCT00274742|E6|Reported Event|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697174|NCT00274742|E5|Reported Event|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
697175|NCT00274742|E4|Reported Event|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697176|NCT00274742|E3|Reported Event|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697218|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
697177|NCT00274742|E2|Reported Event|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697178|NCT00274742|E1|Reported Event|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
697179|NCT00274716|B7|Baseline|Total|Total of all reporting groups
697180|NCT00274716|B6|Baseline|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697181|NCT00274716|B5|Baseline|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697182|NCT00274716|B4|Baseline|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697183|NCT00274716|B3|Baseline|High BMI:MK-0916 6mg→MK-0916 6mg|Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B
697184|NCT00274716|B2|Baseline|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697185|NCT00274716|B1|Baseline|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697186|NCT00274716|P6|Participant Flow|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697187|NCT00274716|P5|Participant Flow|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697188|NCT00274716|P4|Participant Flow|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697189|NCT00274716|P3|Participant Flow|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697190|NCT00274716|P2|Participant Flow|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697191|NCT00274716|P1|Participant Flow|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697192|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697193|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697194|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697195|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697196|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697197|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697198|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697199|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697200|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697201|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697202|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697203|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697204|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697205|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697206|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697207|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697208|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697209|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697210|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697211|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697212|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697213|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697214|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697215|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
703830|NCT00252967|O2|Outcome|Atorvastatin|
697219|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
697220|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
697221|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
697222|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
697223|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
697224|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
697225|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
697226|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
697227|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
697228|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
697229|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
697230|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
697231|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
697232|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
697233|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
697234|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
697235|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
697236|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
697237|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
697238|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
697239|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
697240|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
697241|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
697242|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
697243|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
697244|NCT00274716|E6|Reported Event|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697245|NCT00274716|E5|Reported Event|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697246|NCT00274716|E4|Reported Event|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697247|NCT00274716|E3|Reported Event|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
697248|NCT00274716|E2|Reported Event|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697249|NCT00274716|E1|Reported Event|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
697250|NCT00274651|B3|Baseline|Total|Total of all reporting groups
697251|NCT00274651|B2|Baseline|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697252|NCT00274651|B1|Baseline|CTCL (ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697253|NCT00274651|P2|Participant Flow|Arm B (PTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
697254|NCT00274651|P1|Participant Flow|Arm A (CTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
697255|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697256|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697257|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697258|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697259|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697260|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697261|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697262|NCT00274651|O1|Outcome|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697263|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697264|NCT00274651|E2|Reported Event|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697265|NCT00274651|E1|Reported Event|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
697266|NCT00274625|B3|Baseline|Total|Total of all reporting groups
697995|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
697267|NCT00274625|B2|Baseline|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
697268|NCT00274625|B1|Baseline|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
697269|NCT00274625|P2|Participant Flow|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
697270|NCT00274625|P1|Participant Flow|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
697271|NCT00274625|O2|Outcome|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
697272|NCT00274625|O1|Outcome|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
697273|NCT00274625|E2|Reported Event|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
697274|NCT00274625|E1|Reported Event|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
697275|NCT00274469|B3|Baseline|Total|Total of all reporting groups
697276|NCT00274469|B2|Baseline|Anastrozole 1 mg|Anastrozole 1 mg
697277|NCT00274469|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
697278|NCT00274469|P2|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg
697279|NCT00274469|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
697280|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
697281|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
697282|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
697283|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
697284|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
697285|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
697286|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
697287|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
697288|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
697289|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
697290|NCT00274469|E2|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg
697291|NCT00274469|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
697292|NCT00274456|B5|Baseline|Total|Total of all reporting groups
697293|NCT00274456|B4|Baseline|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697294|NCT00274456|B3|Baseline|ABI-007 150 mg/m^2|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest.
697295|NCT00274456|B2|Baseline|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697296|NCT00274456|B1|Baseline|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697297|NCT00274456|P4|Participant Flow|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697298|NCT00274456|P3|Participant Flow|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697299|NCT00274456|P2|Participant Flow|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697300|NCT00274456|P1|Participant Flow|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697301|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697302|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697303|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697304|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697305|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697306|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697307|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697308|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697309|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697310|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697311|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697312|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697313|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697314|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697315|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697316|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697317|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697318|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697319|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697320|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697321|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697322|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697323|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697324|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697325|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697326|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697327|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697328|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697329|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697330|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697331|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697332|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697333|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697334|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697335|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697336|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697337|NCT00274456|E4|Reported Event|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
697338|NCT00274456|E3|Reported Event|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697339|NCT00274456|E2|Reported Event|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
697340|NCT00274456|E1|Reported Event|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
697341|NCT00274287|B1|Baseline|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
697342|NCT00274287|P1|Participant Flow|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
697343|NCT00274287|O1|Outcome|GM-CSF (Leukine)|Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
697344|NCT00274287|E1|Reported Event|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
697345|NCT00274261|B3|Baseline|Total|Total of all reporting groups
697346|NCT00274261|B2|Baseline|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
697347|NCT00274261|B1|Baseline|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
697348|NCT00274261|P2|Participant Flow|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
697349|NCT00274261|P1|Participant Flow|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
697350|NCT00274261|O2|Outcome|Conceptrol® Vaginal Gel|"Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.~nonoxynol-9 (N-9): The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study."
697351|NCT00274261|O1|Outcome|C31G Vaginal Gel|"C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel~C31G: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study."
697352|NCT00274261|O2|Outcome|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
697353|NCT00274261|O1|Outcome|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
697354|NCT00274261|E2|Reported Event|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
697355|NCT00274261|E1|Reported Event|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
697356|NCT00273910|B7|Baseline|Total|Total of all reporting groups
697357|NCT00273910|B6|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697358|NCT00273910|B5|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697359|NCT00273910|B4|Baseline|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
697360|NCT00273910|B3|Baseline|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697361|NCT00273910|B2|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697362|NCT00273910|B1|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697363|NCT00273910|P6|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697364|NCT00273910|P5|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697365|NCT00273910|P4|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
697366|NCT00273910|P3|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697367|NCT00273910|P2|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697368|NCT00273910|P1|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697369|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697370|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697371|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
697372|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697373|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697374|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697375|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697376|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697377|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
697378|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697379|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697380|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697381|NCT00273910|E6|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697382|NCT00273910|E5|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697383|NCT00273910|E4|Reported Event|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
697384|NCT00273910|E3|Reported Event|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697385|NCT00273910|E2|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
697386|NCT00273910|E1|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
697387|NCT00273858|B1|Baseline|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697388|NCT00273858|P1|Participant Flow|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
703831|NCT00252967|O1|Outcome|Placebo|
697389|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697390|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697391|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697392|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697393|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697394|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697395|NCT00273858|E1|Reported Event|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
697396|NCT00273793|B7|Baseline|Total|Total of all reporting groups
697397|NCT00273793|B6|Baseline|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
697398|NCT00273793|B5|Baseline|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
697399|NCT00273793|B4|Baseline|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
697400|NCT00273793|B3|Baseline|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
697401|NCT00273793|B2|Baseline|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
697402|NCT00273793|B1|Baseline|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
697403|NCT00273793|P6|Participant Flow|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
697404|NCT00273793|P5|Participant Flow|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
697405|NCT00273793|P4|Participant Flow|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
697406|NCT00273793|P3|Participant Flow|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
697407|NCT00273793|P2|Participant Flow|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
697408|NCT00273793|P1|Participant Flow|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
697409|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
697410|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
697411|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
697412|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
697413|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
697414|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
697415|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
697416|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
697417|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
697418|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
697419|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
697420|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
697421|NCT00273793|E6|Reported Event|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
697422|NCT00273793|E5|Reported Event|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
697423|NCT00273793|E4|Reported Event|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
697996|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
697424|NCT00273793|E3|Reported Event|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
697425|NCT00273793|E2|Reported Event|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
697426|NCT00273793|E1|Reported Event|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
697427|NCT00273754|B3|Baseline|Total|Total of all reporting groups
697428|NCT00273754|B2|Baseline|Caffeine|Caffeine benzoate
697429|NCT00273754|B1|Baseline|Placebo|Normal Saline
697430|NCT00273754|P2|Participant Flow|Caffeine|Caffeine benzoate
697431|NCT00273754|P1|Participant Flow|Placebo|Normal Saline
697432|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
697433|NCT00273754|O1|Outcome|Placebo|Normal Saline
697434|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
697435|NCT00273754|O1|Outcome|Placebo|Normal Saline
697436|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
697437|NCT00273754|O1|Outcome|Placebo|Normal Saline
697438|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
697439|NCT00273754|O1|Outcome|Placebo|Normal Saline
697440|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
697441|NCT00273754|O1|Outcome|Placebo|Normal Saline
697442|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
697443|NCT00273754|O1|Outcome|Placebo|Normal Saline
697444|NCT00273754|E2|Reported Event|Caffeine|Caffeine benzoate
697445|NCT00273754|E1|Reported Event|Placebo|Normal Saline
697446|NCT00273182|B1|Baseline|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
697447|NCT00273182|P1|Participant Flow|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
697448|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
697449|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
697450|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
697451|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
697452|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
697453|NCT00273182|E1|Reported Event|All Patients|The analysis included data from all subjects enrolled in the InSync Registry study.
697454|NCT00273052|B3|Baseline|Total|Total of all reporting groups
697455|NCT00273052|B2|Baseline|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697456|NCT00273052|B1|Baseline|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697457|NCT00273052|P2|Participant Flow|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697458|NCT00273052|P1|Participant Flow|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697459|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697460|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697461|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697462|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697463|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697464|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697465|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697466|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697467|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697468|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697469|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697470|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697471|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697472|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697473|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697474|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697475|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697476|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697477|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697478|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697479|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697480|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697481|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697482|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697483|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697484|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697485|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
697486|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
697487|NCT00273052|E2|Reported Event|Toprol XL|Results include only treatment emergent events.
697488|NCT00273052|E1|Reported Event|Coreg CR|Results include only treatment emergent events.
697489|NCT00272987|B4|Baseline|Total|Total of all reporting groups
697490|NCT00272987|B3|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697491|NCT00272987|B2|Baseline|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697492|NCT00272987|B1|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697493|NCT00272987|P3|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697494|NCT00272987|P2|Participant Flow|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697495|NCT00272987|P1|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697496|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697497|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697498|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697499|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697500|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697501|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697502|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697503|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697504|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697505|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697506|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697507|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697508|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697509|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697510|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697511|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697512|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697603|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697513|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697514|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697515|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697516|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697517|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697518|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697519|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697520|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697521|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697522|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697523|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697524|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697525|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697526|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697894|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
697527|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697528|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697529|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697530|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697531|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697532|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697533|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697534|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697535|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697536|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697537|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697538|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697539|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697540|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697895|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
697997|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
697541|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697542|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697543|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697544|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697545|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697546|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697547|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697548|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697549|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697550|NCT00272987|E3|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
697551|NCT00272987|E2|Reported Event|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
697552|NCT00272987|E1|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
697553|NCT00272961|B6|Baseline|Total|Total of all reporting groups
697554|NCT00272961|B5|Baseline|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697555|NCT00272961|B4|Baseline|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697556|NCT00272961|B3|Baseline|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697557|NCT00272961|B2|Baseline|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697558|NCT00272961|B1|Baseline|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697559|NCT00272961|P5|Participant Flow|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697560|NCT00272961|P4|Participant Flow|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697561|NCT00272961|P3|Participant Flow|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697562|NCT00272961|P2|Participant Flow|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697563|NCT00272961|P1|Participant Flow|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697564|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697565|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697566|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697567|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697568|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697569|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697570|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697571|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697572|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697573|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697574|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697575|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697576|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697577|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697578|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697579|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697998|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
697580|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697581|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697582|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697583|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697584|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697585|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697586|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697587|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697588|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697589|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697590|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697591|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697592|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697593|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697594|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697595|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697596|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697597|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697598|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697599|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697600|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697601|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697602|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697999|NCT00271570|E2|Reported Event|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
697604|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697605|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697606|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697607|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697608|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697609|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697610|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697611|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697612|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697613|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697614|NCT00272961|E5|Reported Event|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
697615|NCT00272961|E4|Reported Event|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
697616|NCT00272961|E3|Reported Event|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697617|NCT00272961|E2|Reported Event|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
697618|NCT00272961|E1|Reported Event|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
697619|NCT00272844|B1|Baseline|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
697620|NCT00272844|P1|Participant Flow|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
697621|NCT00272844|O1|Outcome|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
697622|NCT00272844|O1|Outcome|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
697623|NCT00272844|O1|Outcome|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
697624|NCT00272844|E1|Reported Event|Cholesterol Supplementation|crystalline cholesterol oil-based suspension : 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges.
697625|NCT00272792|B3|Baseline|Total|Total of all reporting groups
697626|NCT00272792|B2|Baseline|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
698000|NCT00271570|E1|Reported Event|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
697627|NCT00272792|B1|Baseline|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697628|NCT00272792|P2|Participant Flow|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697629|NCT00272792|P1|Participant Flow|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697630|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697631|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697632|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697633|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697634|NCT00272792|E2|Reported Event|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697635|NCT00272792|E1|Reported Event|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
697636|NCT00272779|B3|Baseline|Total|Total of all reporting groups
697637|NCT00272779|B2|Baseline|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697638|NCT00272779|B1|Baseline|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697639|NCT00272779|P2|Participant Flow|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697640|NCT00272779|P1|Participant Flow|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697641|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697642|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697643|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697644|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697645|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697896|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
703832|NCT00252967|O2|Outcome|Atorvastatin|
697646|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697647|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697648|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697649|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697650|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697651|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697652|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697653|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697654|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697655|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697656|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697657|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697658|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697659|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697660|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697661|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697662|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697663|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697664|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697897|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
698306|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
697665|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697666|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697667|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697668|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697669|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697670|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697671|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697672|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697673|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697674|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697675|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697676|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697677|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697678|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697679|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697680|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697681|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697682|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697683|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697898|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
697684|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697685|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697686|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697687|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697688|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697689|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697690|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697691|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697692|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697693|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697694|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697695|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697696|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697697|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697698|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697699|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697700|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697701|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697702|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697899|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
698307|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
697703|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697704|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697705|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697706|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697707|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697708|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697709|NCT00272779|O1|Outcome|All Participants With Pharmacogenetic Blood Samples|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697710|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697711|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697712|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697713|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697714|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697715|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697716|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697717|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697718|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697719|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697720|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697721|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697900|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
698337|NCT00270257|B3|Baseline|Total|Total of all reporting groups
697722|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697723|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697724|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697725|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697726|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697727|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697728|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697729|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697730|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697731|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697732|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697733|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697734|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697735|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697736|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697737|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697738|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697739|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697740|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697901|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
703833|NCT00252967|O1|Outcome|Placebo|
697741|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697742|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697743|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697744|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697745|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697746|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697747|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697748|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697749|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697750|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697751|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697752|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697753|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697754|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697755|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697756|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697757|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697758|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697759|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697902|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
697760|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697761|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697762|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697763|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697764|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697765|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697766|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697767|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697768|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697769|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697770|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697771|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697772|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697773|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697774|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697775|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697776|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697777|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697778|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697903|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
697779|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697780|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697781|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697782|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697783|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697784|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697785|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697786|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697787|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697788|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697789|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697790|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697791|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697792|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697793|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697794|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697795|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697796|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697797|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697904|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
697798|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697799|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697800|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697801|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697802|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697803|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697804|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697805|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697806|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697807|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697808|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697809|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697810|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697811|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697812|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697813|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697814|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697815|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697816|NCT00272779|E2|Reported Event|LPV/RTV/Tenofovir/Emtricitabine|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
697905|NCT00271856|E2|Reported Event|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
703834|NCT00252967|O2|Outcome|Atorvastatin|
697817|NCT00272779|E1|Reported Event|ATV/RTV/Tenofovir/Emtricitabine|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
697818|NCT00272337|B6|Baseline|Total|Total of all reporting groups
697819|NCT00272337|B5|Baseline|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697820|NCT00272337|B4|Baseline|4 of 5 Randomized Treatment Arms|650 mg Aspirin
697821|NCT00272337|B3|Baseline|3 of 5 Randomized Treatment Arms|325 mg Aspirin
697822|NCT00272337|B2|Baseline|2 of 5 Randomized Treatment Arms|162 mg Aspirin
697823|NCT00272337|B1|Baseline|1 of 5 Randomized Treatment Arms|81 mg Aspirin
697824|NCT00272337|P5|Participant Flow|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697825|NCT00272337|P4|Participant Flow|4 of 5 Randomized Treatment Arms|650 mg Aspirin
697826|NCT00272337|P3|Participant Flow|3 of 5 Randomized Treatment Arms|325 mg Aspirin
697827|NCT00272337|P2|Participant Flow|2 of 5 Randomized Treatment Arms|162 mg Aspirin
697828|NCT00272337|P1|Participant Flow|1 of 5 Randomized Treatment Arms|81 mg Aspirin
697829|NCT00272337|O5|Outcome|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697830|NCT00272337|O4|Outcome|4 of 5 Randomized Treatment Arms|650 mg Aspirin
697831|NCT00272337|O3|Outcome|3 of 5 Randomized Treatment Arms|325 mg Aspirin
697832|NCT00272337|O2|Outcome|2 of 5 Randomized Treatment Arms|162 mg Aspirin
697833|NCT00272337|O1|Outcome|1 of 5 Randomized Treatment Arms|81 mg Aspirin
697834|NCT00272337|E5|Reported Event|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697835|NCT00272337|E4|Reported Event|4 of 5 Randomized Treatment Arms|650 mg Aspirin
697836|NCT00272337|E3|Reported Event|3 of 5 Randomized Treatment Arms|325 mg Aspirin
697837|NCT00272337|E2|Reported Event|2 of 5 Randomized Treatment Arms|162 mg Aspirin
697838|NCT00272337|E1|Reported Event|1 of 5 Randomized Treatment Arms|81 mg Aspirin
697839|NCT00272311|B6|Baseline|Total|Total of all reporting groups
697840|NCT00272311|B5|Baseline|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697841|NCT00272311|B4|Baseline|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
697842|NCT00272311|B3|Baseline|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
697843|NCT00272311|B2|Baseline|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
697844|NCT00272311|B1|Baseline|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
697845|NCT00272311|P5|Participant Flow|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697846|NCT00272311|P4|Participant Flow|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
697847|NCT00272311|P3|Participant Flow|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
697848|NCT00272311|P2|Participant Flow|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
697849|NCT00272311|P1|Participant Flow|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
697850|NCT00272311|O5|Outcome|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697851|NCT00272311|O4|Outcome|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
697852|NCT00272311|O3|Outcome|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
697853|NCT00272311|O2|Outcome|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
697854|NCT00272311|O1|Outcome|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
697855|NCT00272311|E5|Reported Event|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
697856|NCT00272311|E4|Reported Event|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
697857|NCT00272311|E3|Reported Event|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
697858|NCT00272311|E2|Reported Event|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
697859|NCT00272311|E1|Reported Event|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
697860|NCT00272168|B3|Baseline|Total|Total of all reporting groups
697861|NCT00272168|B2|Baseline|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697862|NCT00272168|B1|Baseline|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697863|NCT00272168|P2|Participant Flow|Arm 2: Control|"Supportive Treatment for Serious Mental Illness (control)~Supportive Treatment for Serious Mental Illness (SMI): Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697864|NCT00272168|P1|Participant Flow|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697865|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697866|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697867|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697868|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697869|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697870|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697871|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697872|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697873|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697874|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697875|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697876|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697877|NCT00272168|E2|Reported Event|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
697878|NCT00272168|E1|Reported Event|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
697879|NCT00272038|B1|Baseline|Tarceva|Tarceva 150 mg QD
697880|NCT00272038|P1|Participant Flow|Tarceva|Tarceva 150 mg orally every day
697881|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
697882|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
697883|NCT00272038|E1|Reported Event|Tarceva|Tarceva 150 mg QD
697884|NCT00271947|B1|Baseline|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
697885|NCT00271947|P1|Participant Flow|Autologous Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
697886|NCT00271947|O1|Outcome|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
697887|NCT00271947|E1|Reported Event|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
697888|NCT00271856|B3|Baseline|Total|Total of all reporting groups
697889|NCT00271856|B2|Baseline|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
697890|NCT00271856|B1|Baseline|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
697891|NCT00271856|P2|Participant Flow|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
697892|NCT00271856|P1|Participant Flow|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
697893|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
697906|NCT00271856|E1|Reported Event|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
697907|NCT00271817|B4|Baseline|Total|Total of all reporting groups
697908|NCT00271817|B3|Baseline|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
697909|NCT00271817|B2|Baseline|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
697910|NCT00271817|B1|Baseline|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.
697911|NCT00271817|P3|Participant Flow|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
697912|NCT00271817|P2|Participant Flow|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
697913|NCT00271817|P1|Participant Flow|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone.
697914|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
697915|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
697916|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
697917|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
697918|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697919|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697920|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697921|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697922|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697923|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697924|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697925|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
697926|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
697927|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
697928|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
697929|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
697930|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
697931|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
697932|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
697933|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
697934|NCT00271817|E5|Reported Event|Ezetimibe/Simvastatin + Niacin - Part 2|Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population
697935|NCT00271817|E4|Reported Event|Ezetimibe/Simvastatin - Part 2|EZ/Simva group from Part 2 All-Treated Patient as Treated Population
697936|NCT00271817|E3|Reported Event|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin + Niacin group from Part 1
697937|NCT00271817|E2|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin group from Part 1
697938|NCT00271817|E1|Reported Event|Niacin|Niacin group from Part 1
697939|NCT00271739|B3|Baseline|Total|Total of all reporting groups
697993|NCT00271570|P2|Participant Flow|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
697940|NCT00271739|B2|Baseline|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
697941|NCT00271739|B1|Baseline|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
697942|NCT00271739|P2|Participant Flow|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
697943|NCT00271739|P1|Participant Flow|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
697944|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
697945|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
697946|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
697947|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
697948|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
697949|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
697950|NCT00271739|E2|Reported Event|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
697951|NCT00271739|E1|Reported Event|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
697952|NCT00271609|B3|Baseline|Total|Total of all reporting groups
697953|NCT00271609|B2|Baseline|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
697954|NCT00271609|B1|Baseline|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
697955|NCT00271609|P2|Participant Flow|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
697956|NCT00271609|P1|Participant Flow|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
697957|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
697958|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
697959|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
697960|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
697961|NCT00271609|E2|Reported Event|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
697962|NCT00271609|E1|Reported Event|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
697963|NCT00271596|B3|Baseline|Total|Total of all reporting groups
697964|NCT00271596|B2|Baseline|Placebo|Matching daily placebo
697965|NCT00271596|B1|Baseline|Citalopram|20mg daily citalopram
697966|NCT00271596|P2|Participant Flow|Placebo|Matching daily placebo
697967|NCT00271596|P1|Participant Flow|Citalopram|20mg daily citalopram
697968|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697969|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697970|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697971|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697972|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697973|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697974|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697975|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697976|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697977|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697978|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697979|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697980|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697981|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697982|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697983|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697984|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697985|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697986|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
697987|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
697988|NCT00271596|E2|Reported Event|Placebo|Matching daily placebo
697989|NCT00271596|E1|Reported Event|Citalopram|20mg daily citalopram
697990|NCT00271570|B3|Baseline|Total|Total of all reporting groups
697991|NCT00271570|B2|Baseline|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
697992|NCT00271570|B1|Baseline|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
698001|NCT00271544|B1|Baseline|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
698002|NCT00271544|P1|Participant Flow|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
698003|NCT00271544|O1|Outcome|4196 Lead|All enrolled subjects
698004|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode pacing impedance at 12-month
698005|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 12-month
698006|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode R-wave amplitude at implant
698007|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode pacing impedance at 12-month
698008|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold captured at 0.5ms at 12-month
698009|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode R-wave amplitude at 12-month
698010|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
698011|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
698012|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
698013|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
698014|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
698015|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
698016|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
698017|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt with successful CS cannulation
698018|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month
698019|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold capture at 0.5ms at 1-month
698020|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 LV lead implant attempt
698021|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
698022|NCT00271375|B4|Baseline|Total|Total of all reporting groups
698023|NCT00271375|B3|Baseline|Control Group Usual Care|Control: Control group usual care
698024|NCT00271375|B2|Baseline|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698025|NCT00271375|B1|Baseline|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698026|NCT00271375|P3|Participant Flow|Control Group Usual Care|Control: Control group usual care
698027|NCT00271375|P2|Participant Flow|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698028|NCT00271375|P1|Participant Flow|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698029|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698030|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698031|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698032|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698033|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698034|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698035|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698036|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698037|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698038|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698039|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698040|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698041|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698042|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698043|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698044|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698045|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698046|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698047|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698048|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698049|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698050|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698051|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698052|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698053|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698054|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698055|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698056|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
698057|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698058|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698059|NCT00271375|O1|Outcome|Overall Evaluation|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698060|NCT00271375|E3|Reported Event|Arm 3: Control Group Usual Care|Control: Control group usual care
698061|NCT00271375|E2|Reported Event|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
698062|NCT00271375|E1|Reported Event|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
698063|NCT00271219|B3|Baseline|Total|Total of all reporting groups
698064|NCT00271219|B2|Baseline|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698065|NCT00271219|B1|Baseline|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698066|NCT00271219|P2|Participant Flow|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698067|NCT00271219|P1|Participant Flow|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698068|NCT00271219|O2|Outcome|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698069|NCT00271219|O1|Outcome|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698070|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698071|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698072|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698073|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698074|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698075|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698076|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698077|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698078|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698079|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698080|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698081|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698082|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698083|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698084|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698085|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
698086|NCT00271219|E4|Reported Event|Buprenorphine: Neonates|Neonates born to mothers maintained on buprenorphine
698087|NCT00271219|E3|Reported Event|Methadone: Neonates|Neonates born to mothers maintained on methadone
698088|NCT00271219|E2|Reported Event|Buprenorphine: Mothers|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
698089|NCT00271219|E1|Reported Event|Methadone: Mothers|"Methadone~Methadone : daily oral dosing 20-140 mg"
698090|NCT00271154|B3|Baseline|Total|Total of all reporting groups
698091|NCT00271154|B2|Baseline|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
698092|NCT00271154|B1|Baseline|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
698093|NCT00271154|P2|Participant Flow|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
698094|NCT00271154|P1|Participant Flow|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
698095|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
698096|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
698097|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
698098|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
698099|NCT00271154|E3|Reported Event|Not Randomized|These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
698100|NCT00271154|E2|Reported Event|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
703835|NCT00252967|O1|Outcome|Placebo|
698101|NCT00271154|E1|Reported Event|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
698102|NCT00271024|B5|Baseline|Total|Total of all reporting groups
698103|NCT00271024|B4|Baseline|Placebo - FEMALE|Females receiving placebo as part of the trial
698104|NCT00271024|B3|Baseline|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698105|NCT00271024|B2|Baseline|Placebo - MALE|Males receiving placebo as part of the trial
698106|NCT00271024|B1|Baseline|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698107|NCT00271024|P4|Participant Flow|Placebo - FEMALE|Females receiving placebo as part of the trial
698108|NCT00271024|P3|Participant Flow|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698109|NCT00271024|P2|Participant Flow|Placebo - MALE|Males receiving placebo as part of the trial
698110|NCT00271024|P1|Participant Flow|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698111|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698112|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698113|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698114|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698115|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698116|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698117|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698118|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698119|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698120|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698121|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698122|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698123|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698124|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698125|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698126|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698127|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698128|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698129|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698130|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698131|NCT00271024|O2|Outcome|Naltrexone|Participants receiving Naltrexone as part of the trial
698132|NCT00271024|O1|Outcome|Placebo|Participants receiving Placebo as part of the trial
698133|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698134|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698135|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698136|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698137|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698138|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698139|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698140|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698141|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698142|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698143|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698144|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698145|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
698146|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
698147|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
698148|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
698149|NCT00271024|E2|Reported Event|Naltrexone|Participants receiving Naltrexone as part of the trial
698150|NCT00271024|E1|Reported Event|Placebo|Participants receiving Placebo as part of the trial
698151|NCT00271011|B1|Baseline|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
698152|NCT00271011|P1|Participant Flow|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
698153|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
698154|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
698155|NCT00271011|E1|Reported Event|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
698156|NCT00270998|B4|Baseline|Total|Total of all reporting groups
698157|NCT00270998|B3|Baseline|Combination of Pessary and Behavioral Therapy|Treatment includes a combination of both pessary and pelvic muscle exercises
698158|NCT00270998|B2|Baseline|Behavioral Therapy|Pelvic muscle training and exercises
698159|NCT00270998|B1|Baseline|Pessary|Intravaginal pessary
698160|NCT00270998|P3|Participant Flow|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698161|NCT00270998|P2|Participant Flow|Behavioral Therapy|Pelvic muscle training and exercises
698162|NCT00270998|P1|Participant Flow|Pessary|Intravaginal incontinence pessary
698163|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698164|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698165|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
698166|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698167|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698168|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
698169|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698170|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698171|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
698172|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698173|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698174|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
698175|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698176|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698177|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
698178|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698179|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698180|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
698181|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698182|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698183|NCT00270998|O1|Outcome|Pessary|Intravaginal incontinence pessary
698184|NCT00270998|O3|Outcome|Combination of Pessary and Behavioral Therapy|Treatment includes a combination of both pessary and pelvic muscle exercises
698185|NCT00270998|O2|Outcome|Behavioral Therapy|Pelvic muscle training and exercises
698186|NCT00270998|O1|Outcome|Pessary|Intravaginal pessary
698187|NCT00270998|E3|Reported Event|Combination of Pessary and Behavioral Therapy|Treatment is a combination of both pessary and pelvic muscle exercises
698188|NCT00270998|E2|Reported Event|Behavioral Therapy|Pelvic muscle training and exercises
698189|NCT00270998|E1|Reported Event|Pessary|Intravaginal incontinence pessary
698190|NCT00270894|B1|Baseline|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698191|NCT00270894|P1|Participant Flow|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698192|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698193|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698194|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698195|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
703836|NCT00252967|O2|Outcome|Atorvastatin|
698196|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698197|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698198|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698199|NCT00270894|E1|Reported Event|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
698200|NCT00270855|B3|Baseline|Total|Total of all reporting groups
698201|NCT00270855|B2|Baseline|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698202|NCT00270855|B1|Baseline|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698203|NCT00270855|P2|Participant Flow|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698204|NCT00270855|P1|Participant Flow|Arm Crank Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698205|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698206|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698207|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698208|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698209|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698210|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698211|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698212|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698213|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698214|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698215|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698216|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698217|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698218|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698219|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698220|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698221|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698222|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698223|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698224|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698225|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698226|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698227|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698228|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698229|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698230|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698231|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698232|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698233|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
703837|NCT00252967|O1|Outcome|Placebo|
698234|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698235|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698236|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698237|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698238|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698239|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698240|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698241|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698242|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698243|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698244|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698245|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698246|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698247|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Leg Cycle Ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698248|NCT00270855|O1|Outcome|Arm Crank Ergometer|"Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698249|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Leg Cycle Ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698250|NCT00270855|O1|Outcome|Arm Crank Ergometer|"Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698251|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698252|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698253|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698254|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698255|NCT00270855|O2|Outcome|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698256|NCT00270855|O1|Outcome|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698257|NCT00270855|E2|Reported Event|FESLCE|"Functional Electrical Stimulation Cycle Ergometer for Lower body~FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise"
698258|NCT00270855|E1|Reported Event|Arm Cycling Ergometer|"Upper body Cycle ergometer~Arm Crank Ergometry: Use of an upper body cycle to perform exercise."
698259|NCT00270842|B4|Baseline|Total|Total of all reporting groups
698260|NCT00270842|B3|Baseline|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698261|NCT00270842|B2|Baseline|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698262|NCT00270842|B1|Baseline|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
698263|NCT00270842|P3|Participant Flow|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698264|NCT00270842|P2|Participant Flow|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698265|NCT00270842|P1|Participant Flow|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
698266|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698267|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698268|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
698269|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698270|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698271|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
698272|NCT00270842|E3|Reported Event|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698273|NCT00270842|E2|Reported Event|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
698274|NCT00270842|E1|Reported Event|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
698275|NCT00270790|B1|Baseline|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
698276|NCT00270790|P1|Participant Flow|AMIFOSTINE +2 Chemo Lines +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
698277|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
698278|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
698279|NCT00270790|E1|Reported Event|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
698280|NCT00270634|B5|Baseline|Total|Total of all reporting groups
698281|NCT00270634|B4|Baseline|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698282|NCT00270634|B3|Baseline|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698283|NCT00270634|B2|Baseline|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698284|NCT00270634|B1|Baseline|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698285|NCT00270634|P4|Participant Flow|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698286|NCT00270634|P3|Participant Flow|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698287|NCT00270634|P2|Participant Flow|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698288|NCT00270634|P1|Participant Flow|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698289|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698290|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698291|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698292|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698293|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698294|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698295|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698296|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698297|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698298|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698299|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698300|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698301|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698302|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698303|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698304|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698305|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698308|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698309|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698310|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698311|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698312|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698313|NCT00270634|O4|Outcome|Tacrolimus|Standard dose
698314|NCT00270634|O3|Outcome|Low Dose Voclosporin|Starting dose of 0.4 mg/kg
698315|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Starting dose of 0.6 mg/kg
698316|NCT00270634|O1|Outcome|High Dose Voclosporin|Starting dose of 0.8 mg/kg
698317|NCT00270634|E4|Reported Event|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
698318|NCT00270634|E3|Reported Event|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
698319|NCT00270634|E2|Reported Event|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
698320|NCT00270634|E1|Reported Event|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
698321|NCT00270296|B4|Baseline|Total|Total of all reporting groups
698322|NCT00270296|B3|Baseline|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
698323|NCT00270296|B2|Baseline|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
698324|NCT00270296|B1|Baseline|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
698325|NCT00270296|P3|Participant Flow|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
698326|NCT00270296|P2|Participant Flow|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
698327|NCT00270296|P1|Participant Flow|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
698328|NCT00270296|O3|Outcome|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
698329|NCT00270296|O2|Outcome|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
698330|NCT00270296|O1|Outcome|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
698331|NCT00270296|O3|Outcome|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
698332|NCT00270296|O2|Outcome|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
698333|NCT00270296|O1|Outcome|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
698334|NCT00270296|E3|Reported Event|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
698335|NCT00270296|E2|Reported Event|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
698336|NCT00270296|E1|Reported Event|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
698338|NCT00270257|B2|Baseline|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698339|NCT00270257|B1|Baseline|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698340|NCT00270257|P2|Participant Flow|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698341|NCT00270257|P1|Participant Flow|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698342|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
698343|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
698344|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
698345|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
698346|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698347|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698348|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698349|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698350|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698351|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698352|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698353|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698354|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698355|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698356|NCT00270257|E2|Reported Event|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
698357|NCT00270257|E1|Reported Event|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
698358|NCT00270231|B1|Baseline|Entire Study Population|Includes subjects with both OPRM1 genotypes (Asp40 (A/G or G/G allele vs. Asn40 (A/A) allele) who started Intervention Period 1.
698359|NCT00270231|P2|Participant Flow|Placebo, Then Naltrexone|"These participants took placebo (sugar pill) during their first 4-day study period.~They received active naltrexone during the second 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg."
698360|NCT00270231|P1|Participant Flow|Naltrexone, Then Placebo|"These participants took active naltrexone during their first 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg.~They received placebo (sugar pill) during the second 4-day study period."
698361|NCT00270231|O2|Outcome|OPRM1 Genotype - A/G or G/G|Participants who have the Asp40 OPRM1=A/G or G/G
698362|NCT00270231|O1|Outcome|OPRM1 Genotype - A/A|Participants who have the Asn40 OPRM1=A/A
698363|NCT00270231|E2|Reported Event|Placebo Only|Placebo (sugar pill) recipients (taken for four days).
698364|NCT00270231|E1|Reported Event|Naltrexone Only|Active medication recipients (Naltrexone taken for 4 days).
698365|NCT00270205|B5|Baseline|Total|Total of all reporting groups
698366|NCT00270205|B4|Baseline|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698367|NCT00270205|B3|Baseline|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698368|NCT00270205|B2|Baseline|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698369|NCT00270205|B1|Baseline|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698370|NCT00270205|P4|Participant Flow|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698371|NCT00270205|P3|Participant Flow|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698372|NCT00270205|P2|Participant Flow|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698373|NCT00270205|P1|Participant Flow|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698374|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698375|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698376|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698377|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698378|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698379|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698380|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698381|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698382|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698383|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698384|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698385|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698386|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698387|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698434|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698388|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698389|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698390|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698391|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698392|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698393|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698394|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698395|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698396|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698397|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698398|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698399|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698400|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698401|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698402|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698403|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698404|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698405|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698406|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698407|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698408|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698409|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698410|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698458|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
701535|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
698411|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698412|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698413|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698414|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698415|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698416|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698417|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698418|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698419|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698420|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698421|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698422|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698423|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698424|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698425|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698426|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698427|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698428|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698429|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698430|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698431|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698432|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698433|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698516|NCT00269477|B5|Baseline|Total|Total of all reporting groups
698435|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698436|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698437|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698438|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698439|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698440|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698441|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698442|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698443|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698444|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698445|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698446|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698447|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698448|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698449|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698450|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698451|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698452|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698453|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698454|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698455|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698456|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698457|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
699002|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698459|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698460|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698461|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698462|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698463|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698464|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698465|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698466|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698467|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698468|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698469|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698470|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698471|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698472|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698473|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698474|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698475|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698476|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698477|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698478|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698479|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698480|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698481|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
699003|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698482|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698483|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698484|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698485|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698486|NCT00270205|E4|Reported Event|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
698487|NCT00270205|E3|Reported Event|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
698488|NCT00270205|E2|Reported Event|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
698489|NCT00270205|E1|Reported Event|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
698490|NCT00269919|B1|Baseline|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698491|NCT00269919|P1|Participant Flow|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator’s discretion every 2 weeks for 2 years.
698492|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698493|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698494|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg had been administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698495|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698496|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698497|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698498|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698499|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698500|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698501|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698502|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698503|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698504|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698505|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698506|NCT00269919|E1|Reported Event|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
698507|NCT00269633|B3|Baseline|Total|Total of all reporting groups
698508|NCT00269633|B2|Baseline|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
698509|NCT00269633|B1|Baseline|Red Light Box|"657 nm~Red Light Box: 657 nm Red LED Light"
698510|NCT00269633|P2|Participant Flow|Blue Light Box 467 nm|LED Blue Light Box 467 nm
698511|NCT00269633|P1|Participant Flow|Red Light Box 657 nm|LED Red Light Box 657 nm
698512|NCT00269633|O2|Outcome|Blue Light Box 467 nm|LED Blue Light Box 467 nm
698513|NCT00269633|O1|Outcome|Red Light Box 657 nm|LED Red Light Box 657 nm
698514|NCT00269633|E2|Reported Event|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
698515|NCT00269633|E1|Reported Event|Red Light Box|Red Light Box: 657 nm Blue LED Light
698517|NCT00269477|B4|Baseline|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698518|NCT00269477|B3|Baseline|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
698519|NCT00269477|B2|Baseline|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698520|NCT00269477|B1|Baseline|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
698521|NCT00269477|P4|Participant Flow|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698522|NCT00269477|P3|Participant Flow|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
698523|NCT00269477|P2|Participant Flow|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698524|NCT00269477|P1|Participant Flow|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
698525|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698526|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
698527|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698528|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
698529|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698530|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
698531|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698532|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
698533|NCT00269477|E4|Reported Event|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698534|NCT00269477|E3|Reported Event|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
698535|NCT00269477|E2|Reported Event|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
698536|NCT00269477|E1|Reported Event|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
698537|NCT00269152|B3|Baseline|Total|Total of all reporting groups
698538|NCT00269152|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
701536|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
698539|NCT00269152|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698540|NCT00269152|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
698541|NCT00269152|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698542|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
698543|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698544|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
698545|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698546|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
698547|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698548|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
698549|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698550|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
698551|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698552|NCT00269152|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
698553|NCT00269152|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
698554|NCT00269113|B3|Baseline|Total|Total of all reporting groups
698555|NCT00269113|B2|Baseline|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698556|NCT00269113|B1|Baseline|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698557|NCT00269113|P2|Participant Flow|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698558|NCT00269113|P1|Participant Flow|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1 and 2, chlorambucil 3 times (x) 3 mg/m^2, by mouth (PO), every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a complete remission (CR) or partial remission (PR) following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with interferon (IFN) alpha 3 x 4.5 million international units (IU) per week, subcutaneously (SC), until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698578|NCT00268996|P2|Participant Flow|Darapladib 160mg EC Tablet|Eligible participants received SB-480848 (darapladib) 160 milligram (mg) enteric coated (EC) tablets once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
699004|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698559|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698560|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698561|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698562|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698563|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698564|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698565|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698566|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698579|NCT00268996|P1|Participant Flow|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698580|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
699005|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698567|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698568|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698569|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698570|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698571|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698572|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698573|NCT00269113|E2|Reported Event|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698574|NCT00269113|E1|Reported Event|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
698575|NCT00268996|B3|Baseline|Total|Total of all reporting groups
698576|NCT00268996|B2|Baseline|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698577|NCT00268996|B1|Baseline|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698581|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698582|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet one daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698583|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698584|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698585|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698586|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698587|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698588|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698589|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698590|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698591|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698592|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698593|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698594|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698595|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698596|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698597|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698598|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698599|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698600|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698601|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698602|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698603|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698604|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698605|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698606|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698607|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698608|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698609|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698610|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698611|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698612|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698613|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698614|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698615|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698616|NCT00268996|O2|Outcome|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698617|NCT00268996|O1|Outcome|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698618|NCT00268996|E2|Reported Event|Darapladib 160 mg EC Tablet|Eligible participants received darapladib 160 mg EC tablet once daily for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698619|NCT00268996|E1|Reported Event|Placebo|Eligible participants received the matching placebo for 52 weeks. Participants were instructed to administer one tablet (swallowed intact and not chewed) in the morning each day with food.
698620|NCT00268983|B3|Baseline|Total|Total of all reporting groups
698621|NCT00268983|B2|Baseline|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698622|NCT00268983|B1|Baseline|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698623|NCT00268983|P2|Participant Flow|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698624|NCT00268983|P1|Participant Flow|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698625|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698626|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698627|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698628|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698629|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698630|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698631|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698632|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698633|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698634|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698635|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698636|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698637|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698638|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698639|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698640|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698641|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698642|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698643|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698644|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698645|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698646|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698647|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698648|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698649|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698650|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698651|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698652|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698653|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698654|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698655|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698656|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698657|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698658|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698659|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698660|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698763|NCT00267969|O1|Outcome|Group 1: Ustekinumab 45 mg Withdrawal Group|Patients received ustekinumab 45 mg at Weeks 0, 4, 16 and 28.
698829|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698661|NCT00268983|E2|Reported Event|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
698662|NCT00268983|E1|Reported Event|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
698663|NCT00268905|B4|Baseline|Total|Total of all reporting groups
698664|NCT00268905|B3|Baseline|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
698665|NCT00268905|B2|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
698666|NCT00268905|B1|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
698667|NCT00268905|P3|Participant Flow|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
698668|NCT00268905|P2|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
698669|NCT00268905|P1|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
698670|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
698671|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
698672|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
698673|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
698674|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
698675|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
698676|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
698677|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
698678|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
698679|NCT00268905|E3|Reported Event|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
698680|NCT00268905|E2|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
698681|NCT00268905|E1|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
698682|NCT00268892|B4|Baseline|Total|Total of all reporting groups
698683|NCT00268892|B3|Baseline|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698684|NCT00268892|B2|Baseline|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698685|NCT00268892|B1|Baseline|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698686|NCT00268892|P3|Participant Flow|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698687|NCT00268892|P2|Participant Flow|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698688|NCT00268892|P1|Participant Flow|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698689|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698690|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698830|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698691|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698692|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698693|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698694|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698695|NCT00268892|E3|Reported Event|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698696|NCT00268892|E2|Reported Event|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698697|NCT00268892|E1|Reported Event|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
698698|NCT00268762|B1|Baseline|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
698699|NCT00268762|P1|Participant Flow|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target partial thromboplastin time (PTT) of 1.75 times the patient's baseline.
698700|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
698701|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
698702|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
698703|NCT00268762|E1|Reported Event|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
698704|NCT00268463|B3|Baseline|Total|Total of all reporting groups
698705|NCT00268463|B2|Baseline|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
698706|NCT00268463|B1|Baseline|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
698707|NCT00268463|P2|Participant Flow|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
698708|NCT00268463|P1|Participant Flow|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
698709|NCT00268463|O2|Outcome|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
698710|NCT00268463|O1|Outcome|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
698711|NCT00268463|E2|Reported Event|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
698712|NCT00268463|E1|Reported Event|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
698713|NCT00268437|B1|Baseline|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation >~> carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >~> Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >~> conventional surgery >~> neoadjuvant therapy >~> radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field)."
698714|NCT00268437|P1|Participant Flow|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
698715|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
698764|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
703838|NCT00252967|O2|Outcome|Atorvastatin|
698716|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~conventional surgery"
698717|NCT00268437|E1|Reported Event|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
698718|NCT00268346|B3|Baseline|Total|Total of all reporting groups
698719|NCT00268346|B2|Baseline|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
698720|NCT00268346|B1|Baseline|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
698721|NCT00268346|P2|Participant Flow|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
698722|NCT00268346|P1|Participant Flow|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
698723|NCT00268346|O2|Outcome|Prior Chemotherapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
698724|NCT00268346|O1|Outcome|No Prior Therapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
698725|NCT00268346|E2|Reported Event|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
698726|NCT00268346|E1|Reported Event|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
698727|NCT00268242|B1|Baseline|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698728|NCT00268242|P1|Participant Flow|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698729|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698730|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698731|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698732|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698733|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698734|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698735|NCT00268242|E1|Reported Event|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
698831|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
703839|NCT00252967|O1|Outcome|Placebo|
698736|NCT00268203|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698737|NCT00268203|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698738|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698739|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698740|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698741|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698742|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698765|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
698766|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
703840|NCT00252967|O2|Outcome|Atorvastatin|
698743|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698744|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698745|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698746|NCT00268203|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
698747|NCT00267969|B4|Baseline|Total|Total of all reporting groups
698748|NCT00267969|B3|Baseline|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
698749|NCT00267969|B2|Baseline|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
698750|NCT00267969|B1|Baseline|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
698751|NCT00267969|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
698752|NCT00267969|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
698753|NCT00267969|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
698754|NCT00267969|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
698755|NCT00267969|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
698756|NCT00267969|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
698757|NCT00267969|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
698758|NCT00267969|O6|Outcome|Group 6: Combined Ustekinumab Every 12 Weeks|Groups 2 and 4 (Combined Ustekinumab every 12 weeks)
698759|NCT00267969|O5|Outcome|Group 5: Withdrawal Combined Group|Groups 1 and 3 (Withdrawal Combined)
698760|NCT00267969|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Patients received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
698761|NCT00267969|O3|Outcome|Group 3: Ustekinumab 90 mg Withdrawal|Patients received ustekinumab 90 mg at Weeks 0, 4, 16 and 28.
698762|NCT00267969|O2|Outcome|Group 2: Ustekinumab 45 mg Every 12 Weeks|Patients received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
703841|NCT00252967|O1|Outcome|Placebo|
698767|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
698768|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
698769|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
698770|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
698771|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
698772|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
698773|NCT00267969|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
698774|NCT00267969|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
698775|NCT00267969|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
698776|NCT00267969|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
698777|NCT00267969|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
698778|NCT00267969|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
698779|NCT00267969|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
698780|NCT00267956|B3|Baseline|Total|Total of all reporting groups
698781|NCT00267956|B2|Baseline|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
698782|NCT00267956|B1|Baseline|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
698783|NCT00267956|P4|Participant Flow|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
698784|NCT00267956|P3|Participant Flow|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
698785|NCT00267956|P2|Participant Flow|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab x 4 Group
698786|NCT00267956|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
698787|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
698788|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
698789|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
698790|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
698791|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
698792|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
703842|NCT00252967|O2|Outcome|Atorvastatin|
698793|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
698794|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
698795|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
698796|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
698797|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
698798|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
698799|NCT00267956|E4|Reported Event|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
698800|NCT00267956|E3|Reported Event|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
698801|NCT00267956|E2|Reported Event|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group
698802|NCT00267956|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
698803|NCT00267774|B3|Baseline|Total|Total of all reporting groups
698804|NCT00267774|B2|Baseline|Angio-guided PCI|Angio-guided PCI
698805|NCT00267774|B1|Baseline|FFR Guided PCI|Fractional flow reserve
698806|NCT00267774|P2|Participant Flow|Angio-guided PCI|Angio-guided PCI
698807|NCT00267774|P1|Participant Flow|FFR Guided PCI|Fractional flow reserve
698808|NCT00267774|O2|Outcome|Angio-guided PCI|Angio-guided PCI
698809|NCT00267774|O1|Outcome|FFR Guided PCI|Fractional flow reserve
698810|NCT00267774|O2|Outcome|Angio-guided PCI|Angio-guided PCI
698811|NCT00267774|O1|Outcome|FFR Guided PCI|Fractional flow reserve
698812|NCT00267774|E2|Reported Event|Angio-guided PCI|Angio-guided PCI
698813|NCT00267774|E1|Reported Event|FFR Guided PCI|Fractional flow reserve
698814|NCT00267748|B4|Baseline|Total|Total of all reporting groups
698815|NCT00267748|B3|Baseline|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698816|NCT00267748|B2|Baseline|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698817|NCT00267748|B1|Baseline|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
698818|NCT00267748|P3|Participant Flow|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698819|NCT00267748|P2|Participant Flow|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698820|NCT00267748|P1|Participant Flow|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
698821|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698822|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698823|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698824|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698825|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698826|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698827|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698828|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
703843|NCT00252967|O1|Outcome|Placebo|
698832|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698833|NCT00267748|E3|Reported Event|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
698834|NCT00267748|E2|Reported Event|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
698835|NCT00267748|E1|Reported Event|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
698836|NCT00267696|B1|Baseline|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle~Carboplatin"
698837|NCT00267696|P1|Participant Flow|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
698838|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
698839|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
698840|NCT00267696|E1|Reported Event|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
698841|NCT00267670|B3|Baseline|Total|Total of all reporting groups
698842|NCT00267670|B2|Baseline|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
698843|NCT00267670|B1|Baseline|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
698844|NCT00267670|P2|Participant Flow|Placebo|This group was given a capsule identical to pentoxifylline that contained sucrose.
698845|NCT00267670|P1|Participant Flow|Pentoxifylline|This group was given pentoxifylline 400mg thrice daily (tid) for 1 year
698846|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
698847|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
698848|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
698849|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
698850|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
698851|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
698852|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
698853|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
698854|NCT00267670|E2|Reported Event|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
698855|NCT00267670|E1|Reported Event|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
698856|NCT00267644|B3|Baseline|Total|Total of all reporting groups
698857|NCT00267644|B2|Baseline|Controls|
698858|NCT00267644|B1|Baseline|Cases|
698859|NCT00267644|P2|Participant Flow|Controls|Hydrated Pediatric Patients
698860|NCT00267644|P1|Participant Flow|Cases|Dehydrated Pediatric Patients
698861|NCT00267644|O2|Outcome|Controls|Hydrated Pediatric Patients
698862|NCT00267644|O1|Outcome|Cases|Dehydrated Pediatric Patients
698863|NCT00267644|O2|Outcome|Controls|Pediatric Patients that were hydrated
698864|NCT00267644|O1|Outcome|Cases|Pediatric Patients who were dehydrated
698865|NCT00267644|E2|Reported Event|Controls|
698866|NCT00267644|E1|Reported Event|Cases|
698867|NCT00267631|B3|Baseline|Total|Total of all reporting groups
698868|NCT00267631|B2|Baseline|Normal Body Weight|Children with a BMI of 25 to 75%
698869|NCT00267631|B1|Baseline|At Risk Body Weight|Children with BMI greater adn equal to 85%
698870|NCT00267631|P2|Participant Flow|NOrmal Body Weight|Children with BMI of 25-75%
698871|NCT00267631|P1|Participant Flow|At Risk Body Weight|Children with BMI greater and equal to 85%
698872|NCT00267631|O2|Outcome|Normal Body Weight|Children with BMI of 25-75%
698873|NCT00267631|O1|Outcome|At Risk Body Weight|Children with BMI greater and equal to 85%
698874|NCT00267631|E2|Reported Event|Normal Body Weight|Children with a BMI of 25 to 75%
698875|NCT00267631|E1|Reported Event|At Risk Body Weight|Children with a BMI greater and equal to 85%
698952|NCT00267098|B6|Baseline|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
698876|NCT00267488|B1|Baseline|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698877|NCT00267488|P1|Participant Flow|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698878|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698879|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698880|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698881|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698882|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698883|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698884|NCT00267488|E1|Reported Event|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
698885|NCT00267293|B4|Baseline|Total|Total of all reporting groups
698886|NCT00267293|B3|Baseline|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
698887|NCT00267293|B2|Baseline|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
698888|NCT00267293|B1|Baseline|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
698889|NCT00267293|P3|Participant Flow|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
698890|NCT00267293|P2|Participant Flow|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
698891|NCT00267293|P1|Participant Flow|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
698892|NCT00267293|O3|Outcome|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
698893|NCT00267293|O2|Outcome|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
698894|NCT00267293|O1|Outcome|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
698895|NCT00267293|E3|Reported Event|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
698896|NCT00267293|E2|Reported Event|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
698897|NCT00267293|E1|Reported Event|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
698898|NCT00267202|B3|Baseline|Total|Total of all reporting groups
698899|NCT00267202|B2|Baseline|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698900|NCT00267202|B1|Baseline|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698901|NCT00267202|P2|Participant Flow|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698902|NCT00267202|P1|Participant Flow|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698903|NCT00267202|O3|Outcome|All Patients|
698904|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698905|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698906|NCT00267202|O3|Outcome|All Patients|
698907|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698953|NCT00267098|B5|Baseline|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
703844|NCT00252967|E2|Reported Event|Atorvastatin|
698908|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698909|NCT00267202|O3|Outcome|All Patients|
698910|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698911|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698912|NCT00267202|O3|Outcome|All Patients|
698913|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698914|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698915|NCT00267202|O3|Outcome|All Patients|
698916|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698917|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698918|NCT00267202|E2|Reported Event|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698919|NCT00267202|E1|Reported Event|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
698920|NCT00267189|B3|Baseline|Total|Total of all reporting groups
698921|NCT00267189|B2|Baseline|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
698922|NCT00267189|B1|Baseline|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
698923|NCT00267189|P2|Participant Flow|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
698924|NCT00267189|P1|Participant Flow|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
698925|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
698926|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
698927|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
698928|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
698929|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
698930|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
698931|NCT00267189|E2|Reported Event|Group 2 (Control)|Standard calcineurin inhibitor dose ± mycophenolate acid/azathioprine ± steroids
698932|NCT00267189|E1|Reported Event|Group 1 (Everolimus)|Reduced calcineurin inhibitor dose + everolimus (1.5 mg twice daily) ± steroids
698933|NCT00267150|B1|Baseline|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
698934|NCT00267150|P1|Participant Flow|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
698935|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
698936|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
698937|NCT00267150|E1|Reported Event|All Patients|All patients
698938|NCT00267111|B3|Baseline|Total|Total of all reporting groups
698939|NCT00267111|B2|Baseline|Placebo Group|1 g Eucerin plus was used as a placebo.
698940|NCT00267111|B1|Baseline|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
698941|NCT00267111|P2|Participant Flow|Placebo Group|1 g Eucerin plus was used as a placebo.
698942|NCT00267111|P1|Participant Flow|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
698943|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
698944|NCT00267111|O1|Outcome|Amethocaine Gel 4% Group|1 g Amethocaine gel 4% was used as the active drug
698945|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
698946|NCT00267111|O1|Outcome|1 g Amethocaine Gel 4%|1 g Amethocaine gel 4% was used as the active drug
698947|NCT00267111|E2|Reported Event|Placebo Group|1 g Eucerin plus was used as a placebo.
698948|NCT00267111|E1|Reported Event|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
698949|NCT00267098|B9|Baseline|Total|Total of all reporting groups
698950|NCT00267098|B8|Baseline|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
698951|NCT00267098|B7|Baseline|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
698954|NCT00267098|B4|Baseline|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
698955|NCT00267098|B3|Baseline|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
698956|NCT00267098|B2|Baseline|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
698957|NCT00267098|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
698958|NCT00267098|P8|Participant Flow|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
698959|NCT00267098|P7|Participant Flow|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
698960|NCT00267098|P6|Participant Flow|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
698961|NCT00267098|P5|Participant Flow|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
698962|NCT00267098|P4|Participant Flow|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
698963|NCT00267098|P3|Participant Flow|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
698964|NCT00267098|P2|Participant Flow|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
698965|NCT00267098|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
698966|NCT00267098|O2|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
698967|NCT00267098|O1|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
698968|NCT00267098|O2|Outcome|Subjects With a CRT-D Implant Attempt|Subjects who underwent an implant attempt for a CRT-D device
698969|NCT00267098|O1|Outcome|Subjects With a CRT-P Implant Attempt|Subjects who underwent an implant attempt for a CRT-P device
698970|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
698971|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
698972|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
698973|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
698974|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
698975|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
698976|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698977|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698978|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698979|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698980|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698981|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698982|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698983|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698984|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698985|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698986|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698987|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698988|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698989|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698990|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698991|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698992|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698993|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698994|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698995|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698996|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698997|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
698998|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
698999|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699000|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699001|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
703845|NCT00252967|E1|Reported Event|Placebo|
699006|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699007|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699008|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699009|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699010|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699011|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699012|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699013|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699014|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699015|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699016|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699017|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699018|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699019|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699020|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699021|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699022|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699023|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699024|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699025|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699026|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699027|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699028|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699029|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699030|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699031|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699032|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699033|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699034|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699035|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699036|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699037|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699038|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699039|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699040|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699041|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699042|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699043|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699044|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699045|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699046|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699047|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699048|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699049|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699050|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699051|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699052|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699053|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699054|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699055|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699056|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699057|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699058|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699059|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699060|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699061|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699062|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699063|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699064|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699065|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699066|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699067|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699068|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
699069|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
699070|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
699071|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
699072|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
699073|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
699074|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
699075|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
699076|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699077|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699078|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699079|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699080|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699081|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699082|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699083|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699084|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699085|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699086|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699087|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699088|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699089|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699090|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
699091|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
699092|NCT00267098|E5|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
699093|NCT00267098|E4|Reported Event|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
699094|NCT00267098|E3|Reported Event|CRT: Not Randomized|Subjects successfully implanted with a CRT device who were not randomized
699095|NCT00267098|E2|Reported Event|Right Ventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive right ventricular pacing
699096|NCT00267098|E1|Reported Event|Biventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive biventricular pacing
699097|NCT00267085|B1|Baseline|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
699098|NCT00267085|P1|Participant Flow|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
699099|NCT00267085|O1|Outcome|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
699100|NCT00267085|E1|Reported Event|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
699101|NCT00267059|B1|Baseline|Lenalidomide|10 mg/day, orally once a day for 28 days
699102|NCT00267059|P1|Participant Flow|Lenalidomide|10 mg/day, orally once a day for 28 days
699103|NCT00267059|O1|Outcome|Lenalidomide|10 mg/day, orally once a day for 28 days
699104|NCT00267059|E1|Reported Event|Lenalidomide|10 mg/day, orally once a day for 28 days
699105|NCT00267046|B3|Baseline|Total|Total of all reporting groups
699106|NCT00267046|B2|Baseline|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699107|NCT00267046|B1|Baseline|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699150|NCT00266864|B2|Baseline|No Intervention|Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
699151|NCT00266864|B1|Baseline|Testosterone Replacement Therapy|Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
699108|NCT00267046|P2|Participant Flow|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699109|NCT00267046|P1|Participant Flow|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699110|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699111|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699112|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699113|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699114|NCT00267046|E2|Reported Event|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699115|NCT00267046|E1|Reported Event|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
699116|NCT00267007|B3|Baseline|Total|Total of all reporting groups
699117|NCT00267007|B2|Baseline|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
699118|NCT00267007|B1|Baseline|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
699119|NCT00267007|P2|Participant Flow|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
699120|NCT00267007|P1|Participant Flow|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
699121|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
699122|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
699123|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
699124|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
699125|NCT00267007|E2|Reported Event|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
699126|NCT00267007|E1|Reported Event|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
699127|NCT00266877|B4|Baseline|Total|Total of all reporting groups
699128|NCT00266877|B3|Baseline|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699129|NCT00266877|B2|Baseline|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699130|NCT00266877|B1|Baseline|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699131|NCT00266877|P3|Participant Flow|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699132|NCT00266877|P2|Participant Flow|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699133|NCT00266877|P1|Participant Flow|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699134|NCT00266877|O3|Outcome|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699135|NCT00266877|O2|Outcome|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699136|NCT00266877|O1|Outcome|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699137|NCT00266877|O3|Outcome|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699138|NCT00266877|O2|Outcome|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699139|NCT00266877|O1|Outcome|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699140|NCT00266877|O3|Outcome|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699141|NCT00266877|O2|Outcome|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699142|NCT00266877|O1|Outcome|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699143|NCT00266877|O3|Outcome|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699144|NCT00266877|O2|Outcome|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699145|NCT00266877|O1|Outcome|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699146|NCT00266877|E3|Reported Event|No Prior EGFR Tyrosine Kinase Inhibitor Treatment|"Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699147|NCT00266877|E2|Reported Event|Prior Tarceva or Iressa w/o EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699148|NCT00266877|E1|Reported Event|Prior Tarceva or Iressa With EGFR Mutation|"Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening~HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability."
699149|NCT00266864|B3|Baseline|Total|Total of all reporting groups
699152|NCT00266864|P2|Participant Flow|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
699153|NCT00266864|P1|Participant Flow|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
699154|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
699155|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Testosterone Replacement Therapy Patch 5 or 10 mg daily
699156|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
699157|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
699158|NCT00266864|E1|Reported Event|Testosterone Replacement Therapy|A prospective, open-label, controlled drug intervention trial was performed in healthy hypogonadal and eugonadal outpatient men with chronic spinal cord injury (Treatment: serum testosterone concentration <4.0 mg/dL and Control: serum testosterone concentration ≥4.0 mg/dL). Treatment subjects received a transdermal testosterone patch (5 or 10 mg; Androderm, Watson Pharma Inc.) daily for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. Only outcome measures were assessed for the no intervention arm; no adverse events were collected.
699159|NCT00266825|B3|Baseline|Total|Total of all reporting groups
699160|NCT00266825|B2|Baseline|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699161|NCT00266825|B1|Baseline|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699162|NCT00266825|P2|Participant Flow|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699163|NCT00266825|P1|Participant Flow|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699164|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699165|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699166|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699167|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699168|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699169|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699170|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699171|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699172|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699173|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699174|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699175|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699176|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699177|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699178|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699179|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699180|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
699181|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
699182|NCT00266825|E4|Reported Event|DHA Capsule - Infant|Infants born from Mothers in the DHA capsule group
699183|NCT00266825|E3|Reported Event|DHA Capsule - Mother|"DHA capsule~DHA: 600 mg DHA"
699184|NCT00266825|E2|Reported Event|Placebo Capsule - Infant|Infants born from Mothers in the Placebo capsule group
699185|NCT00266825|E1|Reported Event|Placebo Capsule - Mother|"Placebo capsule~Placebo capsule: Placebo capsule"
699186|NCT00266812|B3|Baseline|Total|Total of all reporting groups
699187|NCT00266812|B2|Baseline|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
699188|NCT00266812|B1|Baseline|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
699189|NCT00266812|P2|Participant Flow|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
699190|NCT00266812|P1|Participant Flow|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
699191|NCT00266812|O2|Outcome|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
699192|NCT00266812|O1|Outcome|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
699193|NCT00266812|E2|Reported Event|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
699194|NCT00266812|E1|Reported Event|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
699195|NCT00266799|B3|Baseline|Total|Total of all reporting groups
699196|NCT00266799|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699197|NCT00266799|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699198|NCT00266799|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699199|NCT00266799|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699200|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699201|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699202|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699203|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699204|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699205|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699206|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699207|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699208|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699209|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699210|NCT00266799|E2|Reported Event|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
699211|NCT00266799|E1|Reported Event|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
699212|NCT00266695|B1|Baseline|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699213|NCT00266695|P1|Participant Flow|Ruboxistaurin|32 milligrams (mg) given once daily as an oral tablet for 2 years.
699214|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699215|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699216|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699217|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699218|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699219|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699220|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699221|NCT00266695|E1|Reported Event|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
699222|NCT00266656|B3|Baseline|Total|Total of all reporting groups
699223|NCT00266656|B2|Baseline|Early Untreated|Early untreated n=33
699224|NCT00266656|B1|Baseline|Early Treated|Early treated n=36
699225|NCT00266656|P2|Participant Flow|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699226|NCT00266656|P1|Participant Flow|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699227|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699228|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699229|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699230|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699231|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699232|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699297|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699233|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699234|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699235|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699236|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699237|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699238|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699239|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699240|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699241|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699242|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699243|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699244|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699245|NCT00266656|E2|Reported Event|Early Untreated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
699246|NCT00266656|E1|Reported Event|Early Treated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
699247|NCT00266630|B3|Baseline|Total|Total of all reporting groups
699248|NCT00266630|B2|Baseline|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699249|NCT00266630|B1|Baseline|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699250|NCT00266630|P2|Participant Flow|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699251|NCT00266630|P1|Participant Flow|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699252|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699253|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699254|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699255|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699256|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699257|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699258|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699259|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699260|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699261|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699262|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699263|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699264|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699265|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699266|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699267|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699268|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699269|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699270|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699271|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699272|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699273|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699274|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699275|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699276|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699277|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699278|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699279|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699280|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699281|NCT00266630|O1|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699282|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699283|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699284|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699285|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
699286|NCT00266630|E2|Reported Event|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
699287|NCT00266630|E1|Reported Event|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
699288|NCT00266409|B5|Baseline|Total|Total of all reporting groups
699289|NCT00266409|B4|Baseline|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699290|NCT00266409|B3|Baseline|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699291|NCT00266409|B2|Baseline|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699292|NCT00266409|B1|Baseline|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699293|NCT00266409|P4|Participant Flow|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699294|NCT00266409|P3|Participant Flow|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699295|NCT00266409|P2|Participant Flow|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699296|NCT00266409|P1|Participant Flow|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699298|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699299|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699300|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699301|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699302|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699303|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699304|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699305|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699306|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699307|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699308|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699309|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699310|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699311|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699312|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699313|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699314|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699315|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699316|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699317|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699318|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699319|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699320|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699321|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699322|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699323|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699324|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699325|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699326|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699327|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699328|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699329|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699330|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699331|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699332|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699333|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699334|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699335|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699336|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699337|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699338|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699339|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699340|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699341|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699342|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699343|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699344|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699345|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699346|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699347|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699348|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699349|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699350|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699351|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699352|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699463|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699353|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699354|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699355|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699356|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699357|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699358|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699359|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699360|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699361|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699362|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699363|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699364|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699365|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699366|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699367|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699368|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699369|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699370|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699371|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699372|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699373|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699374|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699375|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699376|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699377|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699378|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699379|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699380|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699381|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699382|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699383|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699384|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699385|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699386|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699387|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699388|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699389|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699390|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699391|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699392|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699393|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699394|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699395|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699396|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699397|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699398|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699399|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699400|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699401|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699402|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699403|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699404|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699405|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699406|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699407|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699519|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699408|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699409|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699410|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699411|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699412|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699413|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699414|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699415|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699416|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699417|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699418|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699419|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699420|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699421|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699422|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699423|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699424|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699425|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699426|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699427|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699428|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699429|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699430|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699431|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699432|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699433|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699434|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699435|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699436|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699437|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699438|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699439|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699440|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699441|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699442|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699443|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699444|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699445|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699446|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699447|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699448|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699449|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699450|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699451|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699452|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699453|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699454|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699455|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699456|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699457|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699458|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699459|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699460|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699461|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699462|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
703846|NCT00252733|B3|Baseline|Total|Total of all reporting groups
699464|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699465|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699466|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699467|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699468|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699469|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699470|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699471|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699472|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699473|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699474|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699475|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699476|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699477|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699478|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699479|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699480|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699481|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699482|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699483|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699484|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699485|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699486|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699487|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699488|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699489|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699490|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699491|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699492|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699493|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699494|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699495|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699496|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699497|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699498|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699499|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699500|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699501|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699502|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699503|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699504|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699505|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699506|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699507|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699508|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699509|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699510|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699511|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699512|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699513|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699514|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699515|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699516|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699517|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699518|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
703847|NCT00252733|B2|Baseline|Placebo|Placebo Comparator
699520|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699521|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699522|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699523|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699524|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699525|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699526|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699527|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699528|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699529|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699530|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699531|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699532|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699533|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699534|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699535|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699536|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699537|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699538|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699539|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699540|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699541|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699542|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699543|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699544|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699545|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699546|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699547|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699548|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699549|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699550|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699551|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699552|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699553|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699554|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699555|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699556|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699557|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699558|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699559|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699560|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699561|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699562|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699563|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699564|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699565|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699566|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699567|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699568|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699569|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699570|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
699571|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699572|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699573|NCT00266409|E4|Reported Event|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
699574|NCT00266409|E3|Reported Event|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
703866|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
699575|NCT00266409|E2|Reported Event|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
699576|NCT00266409|E1|Reported Event|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
699577|NCT00266279|B1|Baseline|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
699578|NCT00266279|P1|Participant Flow|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
699579|NCT00266279|O1|Outcome|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
699580|NCT00266279|E1|Reported Event|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
699581|NCT00266227|B3|Baseline|Total|Total of all reporting groups
699582|NCT00266227|B2|Baseline|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699583|NCT00266227|B1|Baseline|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699584|NCT00266227|P3|Participant Flow|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
699585|NCT00266227|P2|Participant Flow|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
699586|NCT00266227|P1|Participant Flow|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699587|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699588|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699589|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699590|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699591|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699592|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699593|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699594|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699595|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699596|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699597|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699598|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699599|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699600|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699601|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699602|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699603|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699604|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699605|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699606|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699607|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699608|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699609|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699610|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699611|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699612|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699613|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699614|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699615|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699616|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699617|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699618|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699619|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699620|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699621|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699622|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699623|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699624|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699625|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
699626|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
701537|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
699627|NCT00266227|E3|Reported Event|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
699628|NCT00266227|E2|Reported Event|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
699629|NCT00266227|E1|Reported Event|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
699630|NCT00266110|B1|Baseline|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
699631|NCT00266110|P1|Participant Flow|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~Sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~Therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed dendritic cells (DCs) given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~Trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
699632|NCT00266110|O1|Outcome|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
699633|NCT00266110|E1|Reported Event|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
699634|NCT00266032|B4|Baseline|Total|Total of all reporting groups
699635|NCT00266032|B3|Baseline|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
699636|NCT00266032|B2|Baseline|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699637|NCT00266032|B1|Baseline|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699638|NCT00266032|P3|Participant Flow|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
699639|NCT00266032|P2|Participant Flow|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699654|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
701538|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
699640|NCT00266032|P1|Participant Flow|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699641|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699642|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699643|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699644|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699645|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
699646|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699647|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699648|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
699649|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699650|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699651|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
699652|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699653|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699655|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699656|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699657|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699658|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699659|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699660|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699661|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
699662|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699663|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699664|NCT00266032|E3|Reported Event|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
699665|NCT00266032|E2|Reported Event|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
699666|NCT00266032|E1|Reported Event|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
699667|NCT00265941|B3|Baseline|Total|Total of all reporting groups
699668|NCT00265941|B2|Baseline|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699669|NCT00265941|B1|Baseline|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699670|NCT00265941|P2|Participant Flow|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699671|NCT00265941|P1|Participant Flow|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699672|NCT00265941|O4|Outcome|No Clinical CR + Positive PET|No clinical nodal complete response; positive post-treatment PET/CT scan
699673|NCT00265941|O3|Outcome|Clinical CR + Positive PET|Clinical nodal complete response; positive post-treatment PET/CT scan
699674|NCT00265941|O2|Outcome|No Clinical CR + Negative PET|Did not have clinical nodal complete response; negative post-treatment PET/CT scan
699675|NCT00265941|O1|Outcome|Clinical CR + Negative PET|Clinical nodal complete response; negative post-treatment PET/CT scan
699676|NCT00265941|O2|Outcome|High PET SUVmax|Greater than median pretreatment PET SUVmax
699677|NCT00265941|O1|Outcome|Low PET SUVmax|Less than or equal to median pretreatment PET SUVmax
699678|NCT00265941|O2|Outcome|High EGFR|Greater than or equal to 80% EGFR
699679|NCT00265941|O1|Outcome|Low EGFR|Less than 80% EGFR
699680|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699681|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699682|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699683|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699684|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699685|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699686|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699687|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699688|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699689|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699690|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699691|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699692|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699693|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699694|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699695|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699696|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699697|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699698|NCT00265941|O2|Outcome|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699699|NCT00265941|O1|Outcome|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699700|NCT00265941|E2|Reported Event|RT + Cisplatin + Cetuximab|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
699701|NCT00265941|E1|Reported Event|RT + Cisplatin|Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
699702|NCT00265889|B1|Baseline|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
699703|NCT00265889|P1|Participant Flow|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
699704|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
699705|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
699706|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
699707|NCT00265889|E1|Reported Event|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
699708|NCT00265850|B4|Baseline|Total|Total of all reporting groups
699731|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
699757|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699709|NCT00265850|B3|Baseline|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699710|NCT00265850|B2|Baseline|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699711|NCT00265850|B1|Baseline|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699712|NCT00265850|P3|Participant Flow|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699713|NCT00265850|P2|Participant Flow|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699714|NCT00265850|P1|Participant Flow|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699715|NCT00265850|O3|Outcome|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699716|NCT00265850|O2|Outcome|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699755|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699793|NCT00265512|B3|Baseline|Total|Total of all reporting groups
699717|NCT00265850|O1|Outcome|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699718|NCT00265850|O3|Outcome|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699719|NCT00265850|O2|Outcome|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699720|NCT00265850|O1|Outcome|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699721|NCT00265850|E2|Reported Event|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699722|NCT00265850|E1|Reported Event|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
699723|NCT00265798|B1|Baseline|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
699724|NCT00265798|P1|Participant Flow|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
699725|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
699726|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
699727|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
699728|NCT00265798|E1|Reported Event|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
699729|NCT00265785|B1|Baseline|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
699730|NCT00265785|P1|Participant Flow|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
699756|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699732|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
699733|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
699734|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
699735|NCT00265785|E1|Reported Event|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
699736|NCT00265759|B7|Baseline|Total|Total of all reporting groups
699737|NCT00265759|B6|Baseline|Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
699738|NCT00265759|B5|Baseline|Cohort B Arm II: Week 2 Ki67 >10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
699739|NCT00265759|B4|Baseline|Cohort B Arm I: Week 2 Ki67 <=10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
699740|NCT00265759|B3|Baseline|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699741|NCT00265759|B2|Baseline|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699742|NCT00265759|B1|Baseline|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699743|NCT00265759|P4|Participant Flow|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
699744|NCT00265759|P3|Participant Flow|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
699745|NCT00265759|P2|Participant Flow|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
699746|NCT00265759|P1|Participant Flow|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
699747|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699748|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699749|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699750|NCT00265759|O1|Outcome|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
699751|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699752|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699753|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699754|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699758|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699759|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699760|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699761|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699762|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699763|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699764|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699765|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699766|NCT00265759|O1|Outcome|Cohort B Arm II: Week 2 Ki67 > 10%|Patients who after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy had a tumor Ki67 level of greater than 10% and switched to neoadjuvant chemotherapy.
699767|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699768|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699769|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699770|NCT00265759|E4|Reported Event|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
699771|NCT00265759|E3|Reported Event|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699772|NCT00265759|E2|Reported Event|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699773|NCT00265759|E1|Reported Event|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
699774|NCT00265616|B3|Baseline|Total|Total of all reporting groups
699775|NCT00265616|B2|Baseline|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699776|NCT00265616|B1|Baseline|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699777|NCT00265616|P2|Participant Flow|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG); no maximum doses defined.
699778|NCT00265616|P1|Participant Flow|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG);no maximum doses defined.
699779|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699780|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699781|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699782|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699783|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699784|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699785|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699786|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699787|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699788|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699789|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699790|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699791|NCT00265616|E2|Reported Event|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699792|NCT00265616|E1|Reported Event|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
699794|NCT00265512|B2|Baseline|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
699795|NCT00265512|B1|Baseline|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
699796|NCT00265512|P2|Participant Flow|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
699797|NCT00265512|P1|Participant Flow|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
699798|NCT00265512|O2|Outcome|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
699799|NCT00265512|O1|Outcome|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
699800|NCT00265512|E2|Reported Event|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.~SAEs were tracked, but AEs were not tracked."
699801|NCT00265512|E1|Reported Event|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.~SAEs were tracked, but AEs were not tracked."
699802|NCT00265473|B1|Baseline|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
699803|NCT00265473|P1|Participant Flow|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
699804|NCT00265473|O1|Outcome|Experimental|Islet infusion
699805|NCT00265473|O1|Outcome|Experimental|Islet infusion
699806|NCT00265473|O1|Outcome|Experimental|Islet infusion
699807|NCT00265473|O1|Outcome|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
699808|NCT00265473|O1|Outcome|Experimental|Islet infusion
699809|NCT00265473|E1|Reported Event|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
699810|NCT00265395|B3|Baseline|Total|Total of all reporting groups
699811|NCT00265395|B2|Baseline|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
699812|NCT00265395|B1|Baseline|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
699813|NCT00265395|P2|Participant Flow|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
699814|NCT00265395|P1|Participant Flow|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
699815|NCT00265395|O2|Outcome|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
699816|NCT00265395|O1|Outcome|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
699817|NCT00265395|E1|Reported Event|Standard Therapy (48-week Treatment)|
699818|NCT00265382|B1|Baseline|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699819|NCT00265382|P1|Participant Flow|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699820|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699821|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699822|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699823|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
704425|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
699824|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699825|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699826|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699827|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699828|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699829|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699830|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699831|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699832|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699833|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699834|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699835|NCT00265382|E1|Reported Event|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
699836|NCT00265343|B3|Baseline|Total|Total of all reporting groups
699837|NCT00265343|B2|Baseline|Olanzapine|5-20 mg daily (QD) orally (PO)
699838|NCT00265343|B1|Baseline|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
699839|NCT00265343|P2|Participant Flow|Olanzapine|5-20 mg daily (QD) orally (PO)
699840|NCT00265343|P1|Participant Flow|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
699841|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
699842|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
699843|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
699844|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
699845|NCT00265343|E2|Reported Event|Olanzapine|
699846|NCT00265343|E1|Reported Event|Asenapine|
699847|NCT00265330|B1|Baseline|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699848|NCT00265330|P1|Participant Flow|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699849|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699896|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699850|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699851|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699852|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699853|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699854|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699855|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699856|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699857|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699858|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699859|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699860|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699861|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699862|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699863|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699864|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699865|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699866|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699994|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
704426|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
699867|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699868|NCT00265330|E1|Reported Event|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
699869|NCT00265317|B5|Baseline|Total|Total of all reporting groups
699870|NCT00265317|B4|Baseline|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699871|NCT00265317|B3|Baseline|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
699872|NCT00265317|B2|Baseline|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
699873|NCT00265317|B1|Baseline|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
699874|NCT00265317|P4|Participant Flow|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699875|NCT00265317|P3|Participant Flow|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
699876|NCT00265317|P2|Participant Flow|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
699877|NCT00265317|P1|Participant Flow|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
699878|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699879|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699880|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699881|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699882|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699883|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699884|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699885|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699886|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699887|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699888|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699889|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699890|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699891|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699892|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699893|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699894|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699895|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
701539|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
699897|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699898|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699899|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699900|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699901|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699902|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699903|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699904|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699905|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699906|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699907|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699908|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699909|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699910|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
699911|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699912|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699913|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699914|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699915|NCT00265317|O1|Outcome|All Participants|All participants in all phases
699916|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699917|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699918|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699919|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699920|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
699921|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699922|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699923|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699924|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699925|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699926|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699927|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699928|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699929|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699930|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699931|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699932|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699933|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699934|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699935|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699936|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699937|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699938|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699939|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699940|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699941|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699942|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699943|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699944|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699945|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
699946|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
699947|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
699948|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
699949|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
699950|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
699951|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699952|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699953|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699954|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
699955|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699956|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days)and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
699957|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
699958|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
699959|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699960|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
700080|NCT00265083|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
699961|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699962|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699963|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699964|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
699965|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699966|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699967|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699968|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
699969|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699970|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699971|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
699972|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
699973|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699974|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699975|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699976|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699977|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699978|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699979|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699980|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699981|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699982|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699983|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699984|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
699985|NCT00265317|E4|Reported Event|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
699986|NCT00265317|E3|Reported Event|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
699987|NCT00265317|E2|Reported Event|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
699988|NCT00265317|E1|Reported Event|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
699989|NCT00265239|B3|Baseline|Total|Total of all reporting groups
699990|NCT00265239|B2|Baseline|Placebo Group|Placebo Group
699991|NCT00265239|B1|Baseline|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
699992|NCT00265239|P2|Participant Flow|Placebo Group|Placebo Group
699993|NCT00265239|P1|Participant Flow|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
699995|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
699996|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
699997|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
699998|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
699999|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
700000|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
700001|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
700002|NCT00265239|E2|Reported Event|Placebo Group|Placebo Group
700003|NCT00265239|E1|Reported Event|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
700004|NCT00265200|B1|Baseline|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
700005|NCT00265200|P1|Participant Flow|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
700006|NCT00265200|O1|Outcome|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
700007|NCT00265200|E1|Reported Event|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
700008|NCT00265122|B7|Baseline|Total|Total of all reporting groups
700009|NCT00265122|B6|Baseline|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
700010|NCT00265122|B5|Baseline|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
700011|NCT00265122|B4|Baseline|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
700012|NCT00265122|B3|Baseline|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
700013|NCT00265122|B2|Baseline|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700014|NCT00265122|B1|Baseline|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700015|NCT00265122|P6|Participant Flow|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
700016|NCT00265122|P5|Participant Flow|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
700017|NCT00265122|P4|Participant Flow|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
700018|NCT00265122|P3|Participant Flow|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
700019|NCT00265122|P2|Participant Flow|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700020|NCT00265122|P1|Participant Flow|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700021|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab SC and Ustekinumab IV
700022|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All participants who received Placebo SC and Placebo IV
700023|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
700024|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
700025|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700026|NCT00265122|O1|Outcome|Population 1:Placebo SC Followed by Ustekinumab 90 mg SC|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 1, 2, 3 (Intervention Period 1: Weeks 0-8), and 90 mg ustekinumab SC at Weeks 8, 9, 10 and 11 (Intervention Period 2: Weeks 8-28)
700027|NCT00265122|O2|Outcome|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
700028|NCT00265122|O1|Outcome|Population 2: Ustekinumab 90 SC|Paticipants received ustekinumab 90 mg subcutaneously (SC) at Weeks 0, 1, 2, and 3 (Intervention Period 1: Weeks 0-8), and did not receive any study agent from Week 8 onward (Intervention Period 2: Weeks 8-28)
700029|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
700030|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All particpants who received Placebo SC and Placebo IV
700076|NCT00265096|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
700031|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
700032|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
700033|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700034|NCT00265122|O1|Outcome|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700035|NCT00265122|E6|Reported Event|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
700036|NCT00265122|E5|Reported Event|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
700037|NCT00265122|E4|Reported Event|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|"Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 26 participants randomized to this treatment group + 1 participant randomized to treatment with Placebo IV followed by Ustekinumab 4.5 mg/kg IV who received ustekinumab IV at Week 0 was included in the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
700038|NCT00265122|E3|Reported Event|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|"Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 8 of 27 participants randomized to this treatment group were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below for the following reasons: 7 participants received placebo only were excluded from the analysis of adverse events and 1 participant received ustekinumab IV at Week 0 and was included in the analysis of adverse events in the treatment group labelled Ustekinumab 4.5 mg/kg IV followed by Placebo IV."
700039|NCT00265122|E2|Reported Event|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
700040|NCT00265122|E1|Reported Event|Population 1: Placebo SC Followed by Ustekinumab SC|"Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. NOTE: 4 of 26 participants randomized to this treatment group received placebo only and were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
700041|NCT00265109|B1|Baseline|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
700042|NCT00265109|P1|Participant Flow|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
700043|NCT00265109|O1|Outcome|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
700044|NCT00265109|E1|Reported Event|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
700045|NCT00265096|B4|Baseline|Total|Total of all reporting groups
700046|NCT00265096|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
700047|NCT00265096|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700048|NCT00265096|B1|Baseline|Group 1: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700049|NCT00265096|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
700050|NCT00265096|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700077|NCT00265096|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
700078|NCT00265096|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
700051|NCT00265096|P1|Participant Flow|Group 1: Placebo|Group 1: Placebo Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700052|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700053|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
700054|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700055|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700056|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700057|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
700058|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700059|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700060|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700061|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700062|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700063|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700064|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700065|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700066|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700067|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700068|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700069|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700070|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700071|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700072|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700073|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
700074|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700075|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
700079|NCT00265083|B4|Baseline|Total|Total of all reporting groups
700081|NCT00265083|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700082|NCT00265083|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700083|NCT00265083|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700084|NCT00265083|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700085|NCT00265083|P1|Participant Flow|Group 1: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700086|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700087|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700088|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700089|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700090|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700091|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700092|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700093|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700094|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700095|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700096|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700097|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700098|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
700099|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
700100|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700101|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
700102|NCT00265083|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
700103|NCT00265083|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
700104|NCT00265083|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
700105|NCT00264875|B1|Baseline|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
700106|NCT00264875|P1|Participant Flow|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
700107|NCT00264875|O1|Outcome|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
700108|NCT00264875|E1|Reported Event|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
700109|NCT00264849|B3|Baseline|Total|Total of all reporting groups
700189|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700110|NCT00264849|B2|Baseline|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700111|NCT00264849|B1|Baseline|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700112|NCT00264849|P2|Participant Flow|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700113|NCT00264849|P1|Participant Flow|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700114|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700115|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700116|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700117|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700118|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700119|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700120|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700121|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700122|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700123|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700124|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700125|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700126|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700127|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
704427|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
700128|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700129|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700130|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700131|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700132|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700133|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700134|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700135|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700136|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700137|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700138|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700139|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700140|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700141|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700142|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700143|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700144|NCT00264849|E2|Reported Event|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
700145|NCT00264849|E1|Reported Event|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
700146|NCT00264810|B3|Baseline|Total|Total of all reporting groups
700147|NCT00264810|B2|Baseline|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
700148|NCT00264810|B1|Baseline|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
700149|NCT00264810|P2|Participant Flow|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
700150|NCT00264810|P1|Participant Flow|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
700151|NCT00264810|O2|Outcome|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
700152|NCT00264810|O1|Outcome|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
700153|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System.
700154|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System
700155|NCT00264810|E2|Reported Event|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
700156|NCT00264810|E1|Reported Event|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
700157|NCT00264797|B3|Baseline|Total|Total of all reporting groups
700158|NCT00264797|B2|Baseline|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700159|NCT00264797|B1|Baseline|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700160|NCT00264797|P2|Participant Flow|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700161|NCT00264797|P1|Participant Flow|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700162|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700163|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700188|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700164|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700165|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700166|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700167|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700168|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700169|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700170|NCT00264797|E2|Reported Event|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700171|NCT00264797|E1|Reported Event|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
700172|NCT00264641|B3|Baseline|Total|Total of all reporting groups
700173|NCT00264641|B2|Baseline|Low RAS Activity|Low RAS activity is defined in the protocol
700174|NCT00264641|B1|Baseline|High RAS Activity|High RAS activity is defined in the protocol
700175|NCT00264641|P2|Participant Flow|Low RAS Activity|Low RAS was defined as serum ACE and plasma angiotensinogen concentration in the lowest quartiles in the population combined with AT2 receptor genotype G
700176|NCT00264641|P1|Participant Flow|High RAS Activity|High RAS was defined as serum ACE and plasma angiotensinogen concentration in the highest quartiles in the population combined with AT2 receptor genotype A
700177|NCT00264641|O1|Outcome|All Study Participants|From a screening population ten subjects with high RAS activity – defined as serum ACE and plasma angiotensinogen concentrations in the highest quartile in the population combined with presence of AT2 receptor genotype A corresponding to low expression of the receptor (maximum stimulation via the AT1 receptor) – were selected And 10 males with low RAS activity – defined as serum ACE and plasma angiotensinogen concentrations in the lowest quartile in the population combined with the presence of AT2 receptor genotype G corresponding to high expression of the receptor (58) (minimum stimulation via the AT1 receptor) were selected
700178|NCT00264641|E2|Reported Event|Low RAS Activity|Low RAS activity is described in the protocol
700179|NCT00264641|E1|Reported Event|High RAS Activity|High RAS activity is described in the protocol
700180|NCT00264576|B3|Baseline|Total|Total of all reporting groups
700181|NCT00264576|B2|Baseline|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700182|NCT00264576|B1|Baseline|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700183|NCT00264576|P2|Participant Flow|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700184|NCT00264576|P1|Participant Flow|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700185|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700186|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700187|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700190|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700191|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700192|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell- culture-derived trivalent influenza vaccine (cTIV).
700193|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700194|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700195|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700196|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700197|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700198|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700199|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700200|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700201|NCT00264576|E2|Reported Event|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
700202|NCT00264576|E1|Reported Event|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
700203|NCT00264550|B5|Baseline|Total|Total of all reporting groups
700204|NCT00264550|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700205|NCT00264550|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700206|NCT00264550|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700207|NCT00264550|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700208|NCT00264550|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700209|NCT00264550|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700210|NCT00264550|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700211|NCT00264550|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700212|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700213|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700214|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
704428|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
700215|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700216|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700217|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700218|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700219|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700220|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700221|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700222|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700223|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700224|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700225|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700226|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700227|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700228|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700229|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700230|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700328|NCT00264290|P2|Participant Flow|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone."
700231|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700232|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700233|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700234|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700235|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700236|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700237|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700238|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700239|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700240|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700241|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700242|NCT00264550|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study.
700243|NCT00264550|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study.
700244|NCT00264550|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study.
700245|NCT00264537|B5|Baseline|Total|Total of all reporting groups
700246|NCT00264537|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700247|NCT00264537|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700279|NCT00264537|E3|Reported Event|Group C: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2, Group 3 and Group 4, who received Golimumab 50 mg and 100 mg SC Injections.
704429|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
700248|NCT00264537|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700249|NCT00264537|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700250|NCT00264537|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700251|NCT00264537|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700252|NCT00264537|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700253|NCT00264537|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700254|NCT00264537|O5|Outcome|Combined: Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700255|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700256|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700257|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700258|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700259|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700260|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700261|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700262|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700326|NCT00264290|B2|Baseline|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
700327|NCT00264290|B1|Baseline|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
700263|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700264|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700265|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate (MTX)|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700266|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700267|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700268|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700269|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700270|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700271|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700272|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700273|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700274|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
700275|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700276|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700277|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700278|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
700384|NCT00264147|E6|Reported Event|Etoricoxib 90 mg Treatment II Period|Treatment II: Etoricoxib 90 mg orally once daily
700280|NCT00264537|E2|Reported Event|Group B: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2 and Group 4, who received only Golimumab 100 mg SC Injections.
700281|NCT00264537|E1|Reported Event|Group A: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. Participants were included from Group 1 and Group 3, who received only Golimumab 50 mg SC Injections.
700282|NCT00264498|B3|Baseline|Total|Total of all reporting groups
700283|NCT00264498|B2|Baseline|Experimental|Gefitinib
700284|NCT00264498|B1|Baseline|Active Comparator|Gemcitabine + Carboplatin
700285|NCT00264498|P2|Participant Flow|Experimental|Gefitinib
700286|NCT00264498|P1|Participant Flow|Active Comparator|Gemcitabine + Carboplatin
700287|NCT00264498|O2|Outcome|Experimental|Gefitinib
700288|NCT00264498|O1|Outcome|Active Comparator|Gemcitabine + Carboplatin
700289|NCT00264498|E2|Reported Event|Experimental|Gefitinib
700290|NCT00264498|E1|Reported Event|Active Comparator|Gemcitabine + Carboplatin
700291|NCT00264381|B3|Baseline|Total|Total of all reporting groups
700292|NCT00264381|B2|Baseline|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
700293|NCT00264381|B1|Baseline|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
700294|NCT00264381|P2|Participant Flow|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
700295|NCT00264381|P1|Participant Flow|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
700296|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
700297|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
700298|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
700299|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
700300|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
700301|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
700302|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
700303|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
700304|NCT00264381|E2|Reported Event|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
700305|NCT00264381|E1|Reported Event|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
700306|NCT00264303|B3|Baseline|Total|Total of all reporting groups
700307|NCT00264303|B2|Baseline|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700308|NCT00264303|B1|Baseline|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700309|NCT00264303|P2|Participant Flow|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700310|NCT00264303|P1|Participant Flow|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700311|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700312|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700313|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700314|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700315|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700316|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700317|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700318|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700319|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700320|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700321|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700322|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700323|NCT00264303|E2|Reported Event|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
700324|NCT00264303|E1|Reported Event|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
700325|NCT00264290|B3|Baseline|Total|Total of all reporting groups
700329|NCT00264290|P1|Participant Flow|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
700330|NCT00264290|O2|Outcome|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
700331|NCT00264290|O1|Outcome|Placebo|placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
700332|NCT00264290|E2|Reported Event|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
700333|NCT00264290|E1|Reported Event|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
700334|NCT00264238|B1|Baseline|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
700335|NCT00264238|P1|Participant Flow|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
700336|NCT00264238|O2|Outcome|Non-Responders: Memantine Open Label|Participants who did not respond to memantine as adjunctive therapy
700337|NCT00264238|O1|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy; that is, Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI0I rating of much or very much improved."
700338|NCT00264238|O2|Outcome|Non-Responders: Memantine Open Label|Participants who did not respond to memantine as adjunctive therapy
700339|NCT00264238|O1|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy defined as Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI-I rating of much or very much improved."
700340|NCT00264238|E1|Reported Event|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
700341|NCT00264147|B6|Baseline|Total|Total of all reporting groups
700342|NCT00264147|B5|Baseline|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
700343|NCT00264147|B4|Baseline|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700344|NCT00264147|B3|Baseline|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700345|NCT00264147|B2|Baseline|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700346|NCT00264147|B1|Baseline|Placebo|Treatment I: Placebo orally once daily
700347|NCT00264147|P6|Participant Flow|Diclofenac 150 mg (Treatment II)|Treatment II: Diclofenac 75 mg orally twice daily
700348|NCT00264147|P5|Participant Flow|Etoricoxib 90 mg|Treatment I and II: Etoricoxib 90 mg orally once daily
700349|NCT00264147|P4|Participant Flow|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700350|NCT00264147|P3|Participant Flow|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700351|NCT00264147|P2|Participant Flow|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700352|NCT00264147|P1|Participant Flow|Placebo|Treatment I: Placebo orally once daily
700353|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
700354|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700355|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700356|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700357|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
700358|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
700359|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700360|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700361|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700362|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
700363|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
700364|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700365|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700366|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700367|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
700368|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
700369|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700370|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700371|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700372|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
700373|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
700374|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700375|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700376|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700377|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
700378|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
700379|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
700380|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
700381|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
700382|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
700383|NCT00264147|E7|Reported Event|Diclofenac 150 mg Treatment II Period|Treatment II: Diclofenac 75 mg orally twice daily
700385|NCT00264147|E5|Reported Event|Etoricoxib 90 mg Treatment I Period|Treatment I: Etoricoxib 90 mg orally once daily
700386|NCT00264147|E4|Reported Event|Etoricoxib 60 mg Treatment I Period|Treatment I: Etoricoxib 60 mg orally once daily
700387|NCT00264147|E3|Reported Event|Etoricoxib 30 mg Treatment I Period|Treatment I: Etoricoxib 30 mg orally once daily
700388|NCT00264147|E2|Reported Event|Etoricoxib 10 mg Treatment I Period|Treatment I: Etoricoxib 10 mg orally once daily
700389|NCT00264147|E1|Reported Event|Placebo Treatment I Period|Treatment I: Placebo orally once daily
700390|NCT00264004|B5|Baseline|Total|Total of all reporting groups
700391|NCT00264004|B4|Baseline|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700392|NCT00264004|B3|Baseline|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700393|NCT00264004|B2|Baseline|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700394|NCT00264004|B1|Baseline|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700395|NCT00264004|P4|Participant Flow|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700396|NCT00264004|P3|Participant Flow|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700397|NCT00264004|P2|Participant Flow|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700398|NCT00264004|P1|Participant Flow|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700399|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700400|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700401|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700402|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700403|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700404|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700405|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700406|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700407|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700408|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700409|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700410|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700411|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700412|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700413|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700414|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700415|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700416|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700417|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700418|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700419|NCT00264004|E4|Reported Event|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
700420|NCT00264004|E3|Reported Event|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
700421|NCT00264004|E2|Reported Event|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
700422|NCT00264004|E1|Reported Event|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
700423|NCT00263887|B3|Baseline|Total|Total of all reporting groups
700424|NCT00263887|B2|Baseline|Placebo|
700425|NCT00263887|B1|Baseline|Prolastin (60 mg/kg Body Weight)|
700426|NCT00263887|P2|Participant Flow|Placebo|
700427|NCT00263887|P1|Participant Flow|Prolastin (60 mg/kg Body Weight)|
700428|NCT00263887|O2|Outcome|Placebo|
700429|NCT00263887|O1|Outcome|Prolastin (60 mg/kg Body Weight)|
700430|NCT00263887|E2|Reported Event|Placebo|
700431|NCT00263887|E1|Reported Event|Prolastin (60 mg/kg Body Weight)|
700432|NCT00263757|B3|Baseline|Total|Total of all reporting groups
700433|NCT00263757|B2|Baseline|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
700434|NCT00263757|B1|Baseline|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
700435|NCT00263757|P2|Participant Flow|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
700436|NCT00263757|P1|Participant Flow|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
700437|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
700438|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
700439|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
700440|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
700441|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
700442|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
700443|NCT00263757|E2|Reported Event|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
700444|NCT00263757|E1|Reported Event|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
700445|NCT00263666|B3|Baseline|Total|Total of all reporting groups
700446|NCT00263666|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
704430|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
700447|NCT00263666|B1|Baseline|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700448|NCT00263666|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700449|NCT00263666|P1|Participant Flow|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700450|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700451|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700452|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700453|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700454|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700455|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700456|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700457|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700458|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700459|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700460|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700461|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700462|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700463|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700464|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700465|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700466|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700467|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700468|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700469|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700470|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700471|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700472|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700473|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700474|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700475|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700476|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700477|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700478|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700479|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700480|NCT00263666|O1|Outcome|Rotarix Group 1|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700481|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700482|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700483|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700484|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700485|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700486|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700487|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700488|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700489|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700490|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700491|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700492|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700493|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700494|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700495|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700496|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700497|NCT00263666|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700498|NCT00263666|E1|Reported Event|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
700499|NCT00263328|B4|Baseline|Total|Total of all reporting groups
700500|NCT00263328|B3|Baseline|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700501|NCT00263328|B2|Baseline|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700502|NCT00263328|B1|Baseline|Tofacitinib|Participants received tacrolimus BID, administered according to standard institutional practice. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700503|NCT00263328|P3|Participant Flow|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700504|NCT00263328|P2|Participant Flow|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700505|NCT00263328|P1|Participant Flow|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months posttransplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
700506|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700731|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700879|NCT00262522|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
700507|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700508|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700509|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700510|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700511|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700512|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700513|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700514|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700515|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700588|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700516|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700517|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700518|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700519|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700520|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700521|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700522|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700523|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700524|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700666|NCT00263211|O1|Outcome|Plavix and Aspirin|"Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.~Plavix"
700667|NCT00263211|O2|Outcome|Observation Only|
700668|NCT00263211|O1|Outcome|Plavix and Aspirin|
700669|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
701540|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
700525|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700526|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700527|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700528|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700529|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
700530|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700531|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700532|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700533|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700670|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
700671|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
700732|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700534|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700535|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700536|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700537|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700538|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700539|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700540|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700541|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700542|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700672|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
700673|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
700733|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700543|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700544|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700545|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700546|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700547|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700548|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700549|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700550|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700551|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700674|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
700675|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
700734|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700552|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700553|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700554|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700555|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700556|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700557|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700558|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700559|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700560|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700676|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
700677|NCT00263211|E2|Reported Event|Observation Only|Observation by treating physician
700880|NCT00262522|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
700881|NCT00262509|B3|Baseline|Total|Total of all reporting groups
700561|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700562|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700563|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700564|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700565|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700566|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700567|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700568|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700569|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700678|NCT00263211|E1|Reported Event|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
700679|NCT00262964|B3|Baseline|Total|Total of all reporting groups
700735|NCT00262873|E1|Reported Event|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700570|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700571|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700572|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700573|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700574|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700575|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700576|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700577|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700578|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700680|NCT00262964|B2|Baseline|NAFLD|Subjects diagnosed with Non-Alcoholic Fatty Liver Disease(NAFLD). Determination of NAFLD was by magnetic resonance spectroscopy of intra-hepatic triglyceride content (defined by greater than 10% lipid to water signal). This group included subjects later randomized into the NAFLD-Niacin, NAFLD-Fenofibrate, and NAFLD-no intervention arms.
700681|NCT00262964|B1|Baseline|Controls|Subjects with normal intra-hepatic triglyceride content (defined by less than 10% lipid to water signal in magnetic resonance spectroscopy).
700875|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
700579|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700580|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700581|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700582|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700583|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700584|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700585|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700586|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700587|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700682|NCT00262964|P4|Participant Flow|NAFLD - no Drug|Subjects with elevated intrahepatic triglyceride (IHTG) levels (>10%) who were measured only once (baseline). These subjects did not undergo drug therapy, in contrast to the NAFLD-niacin and NAFLD-fenofibrate group subjects. IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
700876|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
700589|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700590|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700591|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700592|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700593|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700594|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700595|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700596|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700597|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700683|NCT00262964|P3|Participant Flow|Controls|Subjects with normal intrahepatic fat triglyceride(IHTG) levels (<10%). IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
700684|NCT00262964|P2|Participant Flow|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
700685|NCT00262964|P1|Participant Flow|NAFLD - Niacin|subjects diagnosed with NAFLD were randomized to a sixteen week regimen of niacin.
700686|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin.
700598|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700599|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700600|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700601|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700602|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700603|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700604|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700605|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700606|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700687|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with elevated intrahepatic triglyceride given an eight week course of fenofibrate
700688|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
700689|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
700690|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
700691|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
700692|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
700607|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700608|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700609|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700610|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700611|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700612|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700613|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700614|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700615|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700693|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
700694|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride (>10% signal by MR spectroscopy) given a 16 week course of niacin
700695|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy receiving fenofibrate for eight weeks.
700696|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin
700954|NCT00262080|B4|Baseline|Total|Total of all reporting groups
700616|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700617|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700618|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700619|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700620|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700621|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700622|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700623|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700624|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700697|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy given an eight week course of fenofibrate
700698|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
700699|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
700700|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
700701|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
700702|NCT00262964|O2|Outcome|Controls|subjects with normal intrahepatic triglyceride levels
700625|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700626|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700627|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700628|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700629|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700630|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700631|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700632|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700633|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700703|NCT00262964|O1|Outcome|NAFLD|Subjects with elevated intrahepatic triglyceride (>10% signal compared to H2O) measured by MR Spectroscopy.
700704|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
700705|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy
700706|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
700707|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride content greater than 10% per Magnetic Resonance Spectroscopy
700708|NCT00262964|O2|Outcome|Controls|subjects with normal intra-hepatic triglyceride levels
700634|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700635|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700636|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700637|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700638|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700639|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700640|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700641|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700642|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700709|NCT00262964|O1|Outcome|NAFLD|subjects with intra-hepatic triglyceride content greater than 10%.
700710|NCT00262964|E4|Reported Event|Controls|subjects with normal hepatic triglyceride.
700711|NCT00262964|E3|Reported Event|NAFLD - no Drug|subjects with elevated hepatic triglyceride who did not receive any drug intervention
700712|NCT00262964|E2|Reported Event|NAFLD - Niacin|subjects with intra-hepatic triglyceride signal greater than 10% placed on daily niacin for 16 weeks. The dose of medication will be gradually increased according to the protocol of most clinical trials (59): 500 mg/day during wk 1, 1000 mg/day during wk 2, 1500 mg/day during wks 3, and 2000mg/day during wks 4-16.
700643|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700644|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700645|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700646|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700647|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700648|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700649|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700650|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700651|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700713|NCT00262964|E1|Reported Event|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an weight week regimen of fenofibrate
700714|NCT00262951|B1|Baseline|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
700652|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700653|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700654|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700655|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700656|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700657|NCT00263328|E3|Reported Event|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700658|NCT00263328|E2|Reported Event|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700659|NCT00263328|E1|Reported Event|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
700660|NCT00263211|B3|Baseline|Total|Total of all reporting groups
700661|NCT00263211|B2|Baseline|Observation Only|Observation by treating physician
700662|NCT00263211|B1|Baseline|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
700663|NCT00263211|P2|Participant Flow|Observation Only|Observation by treating physician
700664|NCT00263211|P1|Participant Flow|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
700665|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
700877|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
700715|NCT00262951|P1|Participant Flow|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
700716|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
700717|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
700718|NCT00262951|E1|Reported Event|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
700719|NCT00262925|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
700720|NCT00262925|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
700721|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"Detailed Description Section~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.~alemtuzumab: Given subcutaneously~asparaginase: Given IM~methotrexate: Given IV or orally~dexamethasone: Given orally~leucovorin calcium: Given IV~mercaptopurine tablet: Given orally~vincristine sulfate: Given IV~laboratory biomarker analysis: Correlative studies"
700722|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
700723|NCT00262925|E2|Reported Event|MOAD+Campath-Step 2|"Campath 10 mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
700724|NCT00262925|E1|Reported Event|MOAD+Campath-Step 1|"Campath 5mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
700725|NCT00262873|B1|Baseline|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700726|NCT00262873|P1|Participant Flow|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700727|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700728|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700729|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
700730|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
704431|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
700736|NCT00262860|B1|Baseline|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
700737|NCT00262860|P1|Participant Flow|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
700738|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
700739|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
700740|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
700741|NCT00262860|E1|Reported Event|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
700742|NCT00262847|B4|Baseline|Total|Total of all reporting groups
700743|NCT00262847|B3|Baseline|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
700744|NCT00262847|B2|Baseline|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700745|NCT00262847|B1|Baseline|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700746|NCT00262847|P3|Participant Flow|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
700747|NCT00262847|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700748|NCT00262847|P1|Participant Flow|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700749|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
700750|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700751|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700752|NCT00262847|O3|Outcome|Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
700753|NCT00262847|O2|Outcome|Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700754|NCT00262847|O1|Outcome|Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700755|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
700756|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700757|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700758|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
700759|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700760|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700761|NCT00262847|E3|Reported Event|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
700762|NCT00262847|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700763|NCT00262847|E1|Reported Event|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
700764|NCT00262834|B3|Baseline|Total|Total of all reporting groups
700765|NCT00262834|B2|Baseline|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
700766|NCT00262834|B1|Baseline|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
700767|NCT00262834|P2|Participant Flow|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
700768|NCT00262834|P1|Participant Flow|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
700769|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
700770|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
700771|NCT00262834|O1|Outcome|Arm I|"Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgery of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.~vorinostat: Given orally, conventional surgery to follow.~conventional surgery: Undergo conventional surgery"
700772|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
700773|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
700774|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
700775|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
700776|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
700777|NCT00262834|E1|Reported Event|Vorinostat|"Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).~Only vortinostat group adverse events were reported or collected to assess association of events with the agent in question."
700778|NCT00262821|B3|Baseline|Total|Total of all reporting groups
700779|NCT00262821|B2|Baseline|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700780|NCT00262821|B1|Baseline|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700781|NCT00262821|P2|Participant Flow|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700782|NCT00262821|P1|Participant Flow|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700783|NCT00262821|O2|Outcome|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700784|NCT00262821|O1|Outcome|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700785|NCT00262821|O2|Outcome|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700786|NCT00262821|O1|Outcome|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700787|NCT00262821|O2|Outcome|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700878|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
704432|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
700788|NCT00262821|O1|Outcome|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700789|NCT00262821|E2|Reported Event|Concurrent Cisplatin, Tirapazamine and Radiation|Cisplatin, 60 mg/m2 IV on days 1, 15 and 29; Tirapazamine,220 mg/m2 (max=385 mg) on days 1, 8, 10, 12, 15, 22, 24, 26 and 29; Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700790|NCT00262821|E1|Reported Event|Concurrent Cisplatin and Radiation|Cisplatin, 40 mg/m2 (max = 70 mg) IV on days 1, 8, 15, 22, 29 and 36). Radiation, Pelvic (41.4-45.0 Gy / 23-25 daily fractions) brachytherapy (LDR or HDR) / boost (5.4-9.0 Gy /3-5 daily fractions) to involved parametrium
700791|NCT00262743|B3|Baseline|Total|Total of all reporting groups
700792|NCT00262743|B2|Baseline|Phase II Polyphenon E|2000mg twice daily for 6 months
700793|NCT00262743|B1|Baseline|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice daily for 6 months
700794|NCT00262743|P2|Participant Flow|Phase II Polyphenon E|2000mg orally twice daily for 6 months
700795|NCT00262743|P1|Participant Flow|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice a day for 6 months
700796|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
700797|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
700798|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
700799|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
700800|NCT00262743|E1|Reported Event|Phase II Polyphenon E|2000mg orally twice daily for 6 months
700801|NCT00262730|B1|Baseline|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
700802|NCT00262730|P1|Participant Flow|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
700803|NCT00262730|O1|Outcome|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
700804|NCT00262730|E1|Reported Event|Treatment Arm All Subjects|"poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy~AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI"
700805|NCT00262639|B5|Baseline|Total|Total of all reporting groups
700806|NCT00262639|B4|Baseline|High CIWAar Flumazenil/Gabapentin|
700807|NCT00262639|B3|Baseline|High CIWAar Placebo|
700808|NCT00262639|B2|Baseline|Low CIWAar Flumazenil/Gabapentin|
700809|NCT00262639|B1|Baseline|Low CIWAar Placebo|
700810|NCT00262639|P4|Participant Flow|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700811|NCT00262639|P3|Participant Flow|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700812|NCT00262639|P2|Participant Flow|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700813|NCT00262639|P1|Participant Flow|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700814|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700815|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700816|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700817|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700818|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700819|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700820|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700821|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700822|NCT00262639|E4|Reported Event|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700823|NCT00262639|E3|Reported Event|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700824|NCT00262639|E2|Reported Event|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
700825|NCT00262639|E1|Reported Event|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
700826|NCT00262600|B4|Baseline|Total|Total of all reporting groups
700827|NCT00262600|B3|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700828|NCT00262600|B2|Baseline|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700829|NCT00262600|B1|Baseline|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700830|NCT00262600|P3|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700831|NCT00262600|P2|Participant Flow|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700832|NCT00262600|P1|Participant Flow|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700833|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700834|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700835|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700836|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700837|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700838|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700839|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700840|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700841|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700842|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700843|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700844|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700845|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700846|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700847|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700848|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700849|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700850|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700851|NCT00262600|E3|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
700852|NCT00262600|E2|Reported Event|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
700853|NCT00262600|E1|Reported Event|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
700854|NCT00262522|B5|Baseline|Total|Total of all reporting groups
700855|NCT00262522|B4|Baseline|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
700856|NCT00262522|B3|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
700857|NCT00262522|B2|Baseline|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
700858|NCT00262522|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
700859|NCT00262522|P4|Participant Flow|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
700860|NCT00262522|P3|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
700861|NCT00262522|P2|Participant Flow|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
700862|NCT00262522|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
700863|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
700864|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
700865|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
700866|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
700867|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
700868|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
700869|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
700870|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
700871|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
700872|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
700873|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
700874|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
701541|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
700882|NCT00262509|B2|Baseline|First Intervention, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes."
700883|NCT00262509|B1|Baseline|First Baseline, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes."
700884|NCT00262509|P2|Participant Flow|Intervention First, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes."
700885|NCT00262509|P1|Participant Flow|Baseline First, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes."
700886|NCT00262509|O2|Outcome|Baseline|All Blind Participants, in two separate trials, are walked into a building to a specific location, and then are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is calculated as the average of the trial times.
700887|NCT00262509|O1|Outcome|Intervention|All Blind Participants are trained for 15 minutes in the use of the egress device, then for two separate trials are walked into a building to a specific location, and are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is obtained by averaging the two trial times
700888|NCT00262509|E2|Reported Event|Baseline Egress|Blind subjects are walked into a building to different locations in two separate trials and then asked to find their way out of the building.
700889|NCT00262509|E1|Reported Event|Egress Badge Intervention|Blind Participants are trained for 15 minutes in the use of the egress badge, then for two separate trials they are walked into a building to a different locations, and are asked to find their way out of the building.
700890|NCT00262314|B1|Baseline|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700891|NCT00262314|P1|Participant Flow|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700892|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700893|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700894|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700895|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700896|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700897|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700898|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700899|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700900|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700901|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700902|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700903|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700904|NCT00262314|E1|Reported Event|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
700905|NCT00262301|B4|Baseline|Total|Total of all reporting groups
700906|NCT00262301|B3|Baseline|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
700907|NCT00262301|B2|Baseline|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
700908|NCT00262301|B1|Baseline|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
700909|NCT00262301|P3|Participant Flow|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received, 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase. Patients received 1 vial initially and could receive an additional 1-2 vials within 4 hours at the investigator's discretion."
700910|NCT00262301|P2|Participant Flow|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
700911|NCT00262301|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
700912|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
700913|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
700914|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
700915|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
700916|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
700917|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
700918|NCT00262301|E3|Reported Event|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
700919|NCT00262301|E2|Reported Event|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
700920|NCT00262301|E1|Reported Event|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
700921|NCT00262223|B3|Baseline|Total|Total of all reporting groups
700922|NCT00262223|B2|Baseline|2) Seeking Safety + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo
700923|NCT00262223|B1|Baseline|1) Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
700924|NCT00262223|P2|Participant Flow|2) Seeking Safety + Placebo|"Seeking Safety + Placebo;~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
700925|NCT00262223|P1|Participant Flow|1) Seeking Safety + Sertraline|"Seeking Safety + Sertraline~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
700926|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo;
700927|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
700928|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo
700929|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
700930|NCT00262223|E2|Reported Event|Seeking Seeking + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill Placebo
700931|NCT00262223|E1|Reported Event|Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders, + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
700932|NCT00262119|B4|Baseline|Total|Total of all reporting groups
700933|NCT00262119|B3|Baseline|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700934|NCT00262119|B2|Baseline|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700935|NCT00262119|B1|Baseline|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700936|NCT00262119|P3|Participant Flow|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700937|NCT00262119|P2|Participant Flow|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700938|NCT00262119|P1|Participant Flow|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700939|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700940|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700941|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700942|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700943|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700944|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700945|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700946|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700947|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700948|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700949|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700950|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700951|NCT00262119|E3|Reported Event|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700952|NCT00262119|E2|Reported Event|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700953|NCT00262119|E1|Reported Event|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
700955|NCT00262080|B3|Baseline|Ecallantide (Repeat-Dosing Part Only)|"Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.~One patient was omitted from analysis in the intent-to-treat and per-protocol populations due to the loss of the data for the 4-hour post-dose assessments during treatment episode 1."
700956|NCT00262080|B2|Baseline|Placebo / Ecallantide|Patients treated with placebo in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
700957|NCT00262080|B1|Baseline|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
700958|NCT00262080|P3|Participant Flow|Ecallantide (Repeat Dose Only)|Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.
700959|NCT00262080|P2|Participant Flow|Placebo / Ecallantide|Patients treated with placebo in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
700960|NCT00262080|P1|Participant Flow|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
700961|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
700962|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
700963|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
700964|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
700965|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
700966|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
700967|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
700968|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
700969|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
700970|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
700971|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
700972|NCT00262080|E3|Reported Event|Repeat-Dosing Ecallantide|All patients treated with ecallantide in the repeat-dosing part, regardless of whether they were treated previously in the double-blind part or not. All adverse events reported in all repeat-dosing episodes are included. Patients reporting more than 1 AE with the same preferred term are counted only once for that preferred term.
700973|NCT00262080|E2|Reported Event|Double-Blind Placebo|Patients treated with placebo in the double-blind part only.
700974|NCT00262080|E1|Reported Event|Double Blind - Ecallantide|Patients treated with ecallantide in the double-blind part only.
700975|NCT00262067|B5|Baseline|Total|Total of all reporting groups
700976|NCT00262067|B4|Baseline|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700977|NCT00262067|B3|Baseline|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700978|NCT00262067|B2|Baseline|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700979|NCT00262067|B1|Baseline|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700980|NCT00262067|P4|Participant Flow|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700981|NCT00262067|P3|Participant Flow|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700982|NCT00262067|P2|Participant Flow|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700983|NCT00262067|P1|Participant Flow|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700984|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700985|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700986|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700987|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700988|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700989|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
703848|NCT00252733|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
700990|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700991|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700992|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700993|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700994|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700995|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700996|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700997|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
700998|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
700999|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
701000|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
701001|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
701002|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
701003|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
701004|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
701005|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
701006|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
701007|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
701008|NCT00262067|E4|Reported Event|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
701009|NCT00262067|E3|Reported Event|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
701010|NCT00262067|E2|Reported Event|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
701011|NCT00262067|E1|Reported Event|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
701012|NCT00262041|B5|Baseline|Total|Total of all reporting groups
701013|NCT00262041|B4|Baseline|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
701014|NCT00262041|B3|Baseline|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
701015|NCT00262041|B2|Baseline|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701016|NCT00262041|B1|Baseline|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
701017|NCT00262041|P3|Participant Flow|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
701018|NCT00262041|P2|Participant Flow|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701019|NCT00262041|P1|Participant Flow|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
701020|NCT00262041|O4|Outcome|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
701021|NCT00262041|O3|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701022|NCT00262041|O2|Outcome|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1)
703849|NCT00252733|P2|Participant Flow|Placebo|Placebo Comparator
701023|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
701024|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
701025|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701026|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
701027|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701028|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
701029|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701030|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
701031|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
701032|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701033|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
701034|NCT00262041|E4|Reported Event|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
701035|NCT00262041|E3|Reported Event|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
701036|NCT00262041|E2|Reported Event|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
701037|NCT00262041|E1|Reported Event|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
701038|NCT00262028|B10|Baseline|Total|Total of all reporting groups
701039|NCT00262028|B9|Baseline|MenACWY+PS (3-5 YearsOld)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
701040|NCT00262028|B8|Baseline|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
701041|NCT00262028|B7|Baseline|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701042|NCT00262028|B6|Baseline|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
701043|NCT00262028|B5|Baseline|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701044|NCT00262028|B4|Baseline|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
701045|NCT00262028|B3|Baseline|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701046|NCT00262028|B2|Baseline|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
701047|NCT00262028|B1|Baseline|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701048|NCT00262028|P9|Participant Flow|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
701049|NCT00262028|P8|Participant Flow|MenACWY+DTaP (16-23 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
701050|NCT00262028|P7|Participant Flow|MenACWY (16-23 Months)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701051|NCT00262028|P6|Participant Flow|MenACWY+PnC (12-15 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
701052|NCT00262028|P5|Participant Flow|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701053|NCT00262028|P4|Participant Flow|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
701054|NCT00262028|P3|Participant Flow|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701055|NCT00262028|P2|Participant Flow|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
701056|NCT00262028|P1|Participant Flow|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
701057|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP
701058|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701059|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC
701060|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701061|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
701062|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701063|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
701064|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701065|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP
701066|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701067|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC
701068|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701069|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
701070|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701071|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
701072|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
701073|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
701074|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701075|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
701076|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701077|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
701078|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701079|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
701080|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701081|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
701082|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701083|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
701084|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701085|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine.
701086|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701087|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of MenACWY-PS vaccine
701088|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of MenACWY-CRM conjugate vaccine
701089|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the MenACWY-PS vaccine
701090|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701091|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
701092|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701093|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine
701094|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701095|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
701096|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM vaccine
701097|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
701098|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701099|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
701100|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
701101|NCT00262028|E9|Reported Event|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
701102|NCT00262028|E8|Reported Event|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
701103|NCT00262028|E7|Reported Event|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701104|NCT00262028|E6|Reported Event|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
701105|NCT00262028|E5|Reported Event|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701106|NCT00262028|E4|Reported Event|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
701107|NCT00262028|E3|Reported Event|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701108|NCT00262028|E2|Reported Event|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
701109|NCT00262028|E1|Reported Event|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
701110|NCT00262002|B8|Baseline|Total|Total of all reporting groups
701111|NCT00262002|B7|Baseline|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701112|NCT00262002|B6|Baseline|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701113|NCT00262002|B5|Baseline|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701114|NCT00262002|B4|Baseline|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701115|NCT00262002|B3|Baseline|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
701116|NCT00262002|B2|Baseline|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701117|NCT00262002|B1|Baseline|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701118|NCT00262002|P7|Participant Flow|CA24- (MenACWY Ad- at 2,4m)|"Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701119|NCT00262002|P6|Participant Flow|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701120|NCT00262002|P5|Participant Flow|CA24+ (MenACWY Ad+ at 2,4m)|"Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701121|NCT00262002|P4|Participant Flow|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701122|NCT00262002|P3|Participant Flow|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
701123|NCT00262002|P2|Participant Flow|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701124|NCT00262002|P1|Participant Flow|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701125|NCT00262002|O10|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701126|NCT00262002|O9|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701127|NCT00262002|O8|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701128|NCT00262002|O7|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701129|NCT00262002|O6|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701130|NCT00262002|O5|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701131|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701132|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
701133|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701134|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701135|NCT00262002|O7|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701136|NCT00262002|O6|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701137|NCT00262002|O5|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701138|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701139|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
701140|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701141|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701142|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701143|NCT00262002|O4|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701144|NCT00262002|O3|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701145|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701146|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
701147|NCT00262002|O6|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701148|NCT00262002|O5|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701149|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701150|NCT00262002|O3|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701151|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701152|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701153|NCT00262002|O6|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701154|NCT00262002|O5|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701155|NCT00262002|O4|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701156|NCT00262002|O3|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701157|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701158|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701159|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701160|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701161|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701162|NCT00262002|O3|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701163|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701164|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701165|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701166|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701167|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701168|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701169|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701170|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2,4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701171|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701172|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701173|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701174|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
701175|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701350|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701176|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701177|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701178|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701179|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
701180|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701181|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose ( of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701182|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701183|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701184|NCT00262002|O1|Outcome|UKMenC (Menjugate 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
701185|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701186|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701187|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701188|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701189|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701190|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701191|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701192|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701193|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701194|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701195|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701196|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701197|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701198|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701351|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701199|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701200|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
701201|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
701202|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
701203|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701204|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701205|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701206|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701207|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701208|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
701209|NCT00262002|E7|Reported Event|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701210|NCT00262002|E6|Reported Event|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
701211|NCT00262002|E5|Reported Event|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
701212|NCT00262002|E4|Reported Event|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
701213|NCT00262002|E3|Reported Event|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
701214|NCT00262002|E2|Reported Event|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
701215|NCT00262002|E1|Reported Event|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
701216|NCT00261950|B1|Baseline|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701217|NCT00261950|P1|Participant Flow|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701218|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701219|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701529|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701220|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701221|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701222|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701223|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701224|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701225|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701226|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701227|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701228|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701229|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701230|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701231|NCT00261950|E1|Reported Event|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
701232|NCT00261846|B10|Baseline|Total|Total of all reporting groups
701233|NCT00261846|B9|Baseline|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701234|NCT00261846|B8|Baseline|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701235|NCT00261846|B7|Baseline|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701236|NCT00261846|B6|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701237|NCT00261846|B5|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701238|NCT00261846|B4|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701239|NCT00261846|B3|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701240|NCT00261846|B2|Baseline|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701241|NCT00261846|B1|Baseline|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701242|NCT00261846|P12|Participant Flow|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701243|NCT00261846|P11|Participant Flow|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701244|NCT00261846|P10|Participant Flow|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701245|NCT00261846|P9|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701246|NCT00261846|P8|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701247|NCT00261846|P7|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701248|NCT00261846|P6|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701249|NCT00261846|P5|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701530|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701250|NCT00261846|P4|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701251|NCT00261846|P3|Participant Flow|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase (AP) CML Part 2 of the study.
701252|NCT00261846|P2|Participant Flow|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701253|NCT00261846|P1|Participant Flow|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML) Part 2 of the study.
701254|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701255|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701256|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701257|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701258|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701259|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701260|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701261|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701262|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701263|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701264|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701265|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701266|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701267|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701268|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701269|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701270|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701271|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701272|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701273|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701274|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701275|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701276|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701277|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701278|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701279|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701280|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701281|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701531|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701282|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701283|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701284|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701285|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701286|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701287|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701288|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701289|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701290|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701291|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701292|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701293|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701294|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701295|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701296|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701297|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701298|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701299|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701300|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701301|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701302|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701303|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701304|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701305|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701306|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701307|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701308|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701309|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701310|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701311|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701312|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701313|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701314|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701315|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701316|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701317|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701318|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701319|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701320|NCT00261846|O8|Outcome|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701321|NCT00261846|O7|Outcome|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701322|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701323|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701324|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701325|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701326|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701327|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701328|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701329|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701330|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701331|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701332|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701333|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701334|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701335|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701336|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701337|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701338|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701339|NCT00261846|O5|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701340|NCT00261846|O4|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701341|NCT00261846|O3|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701342|NCT00261846|O2|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701343|NCT00261846|O1|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701344|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701345|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701346|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701347|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701348|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701349|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701532|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701352|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701353|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701354|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701355|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701356|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701357|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701358|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701359|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701360|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701361|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701362|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701363|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701364|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701365|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701366|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701367|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701368|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701369|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701370|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701371|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701372|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701373|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701374|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701375|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701376|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701377|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701378|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701379|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701380|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701381|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701382|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701383|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701384|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701533|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701385|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701386|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701387|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701388|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701389|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701390|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701391|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701392|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701393|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701394|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701395|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701396|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701397|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701398|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701399|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701400|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701401|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701402|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701403|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701404|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701405|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701406|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701407|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701408|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701409|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701410|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701411|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701412|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701413|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701414|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701415|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701416|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701417|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701534|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701418|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701419|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701420|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701421|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701422|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
701423|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701424|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
701425|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701426|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701427|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701428|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701429|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701430|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701431|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701432|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701433|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701434|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701435|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701436|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701437|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701438|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701439|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701440|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701441|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701442|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701443|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701444|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701445|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701446|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701447|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701448|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701449|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701450|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701451|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701452|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701453|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701454|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701455|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701456|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701457|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701458|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701459|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701460|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701461|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701462|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701463|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701464|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701465|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701466|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701467|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701468|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701469|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701470|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701471|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701472|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701473|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701474|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701475|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701476|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701477|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701478|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701479|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701480|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701481|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701482|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701483|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701484|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701485|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701486|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701487|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701488|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701489|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701490|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701491|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701492|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701493|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701494|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701495|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701496|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701497|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
701498|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701499|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
701500|NCT00261846|E9|Reported Event|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
701501|NCT00261846|E8|Reported Event|BP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
701502|NCT00261846|E7|Reported Event|AP-CML Total (Part 2)|All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
701503|NCT00261846|E6|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
701504|NCT00261846|E5|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
701505|NCT00261846|E4|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
701506|NCT00261846|E3|Reported Event|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
701507|NCT00261846|E2|Reported Event|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701508|NCT00261846|E1|Reported Event|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
701509|NCT00261833|B3|Baseline|Total|Total of all reporting groups
701510|NCT00261833|B2|Baseline|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701511|NCT00261833|B1|Baseline|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701512|NCT00261833|P2|Participant Flow|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701513|NCT00261833|P1|Participant Flow|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701514|NCT00261833|O2|Outcome|Placebo|Placebo: Lyophilized preparation: 60 mg/kg body weight/week intravenous
701515|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701516|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701517|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701518|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701519|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701520|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701521|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701522|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701523|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701524|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701525|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701526|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701527|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701528|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701542|NCT00261833|E2|Reported Event|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
701543|NCT00261833|E1|Reported Event|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
701544|NCT00261716|B3|Baseline|Total|Total of all reporting groups
701545|NCT00261716|B2|Baseline|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
701546|NCT00261716|B1|Baseline|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
701547|NCT00261716|P2|Participant Flow|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
701548|NCT00261716|P1|Participant Flow|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
701549|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
701550|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
701551|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
701552|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
701553|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
701554|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
701555|NCT00261716|O2|Outcome|IPS and IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~IE: Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
701556|NCT00261716|O1|Outcome|IPS and VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~VOMI: Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
701557|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
701558|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
701559|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
701560|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
701561|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
701562|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
702584|NCT00257894|B2|Baseline|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
701563|NCT00261716|E2|Reported Event|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
701564|NCT00261716|E1|Reported Event|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
701565|NCT00261495|B3|Baseline|Total|Total of all reporting groups
701566|NCT00261495|B2|Baseline|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701567|NCT00261495|B1|Baseline|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701568|NCT00261495|P2|Participant Flow|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701569|NCT00261495|P1|Participant Flow|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701570|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701571|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701572|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701573|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701574|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701575|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701576|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701577|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701578|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701579|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701580|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701581|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701582|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701583|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701584|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701585|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701586|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701587|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701588|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701589|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701590|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701591|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
702704|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
701592|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701593|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701594|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701595|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701596|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701597|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701598|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701599|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701600|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701601|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701602|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701603|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701604|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701605|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701606|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701607|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701608|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701609|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701610|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701611|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701612|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701613|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701614|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701615|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701616|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701617|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701618|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701619|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701620|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701621|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701622|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
704433|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
701623|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701624|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701625|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701626|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701627|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701628|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701629|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701630|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701631|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701632|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701633|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701634|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701635|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701636|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701637|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701638|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701639|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701640|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701641|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701642|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701643|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701644|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701645|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701646|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701647|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701648|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701649|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701650|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701651|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701652|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701653|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
704434|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
701654|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701655|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701656|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701657|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701658|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701659|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701660|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701661|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701662|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701663|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701664|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701665|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701666|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701667|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701668|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701669|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701670|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701671|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701672|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701673|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701674|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701675|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701676|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701677|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701678|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701679|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701680|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701681|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701682|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701683|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701684|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
704435|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
701685|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701686|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701687|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701688|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701689|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701690|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701691|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701692|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701693|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701694|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701695|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701696|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701697|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701698|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701699|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701700|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701701|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701702|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701703|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701704|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701705|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701706|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701707|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701708|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701709|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701710|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701711|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701712|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701713|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701714|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701715|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
704436|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
701716|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701717|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701718|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701719|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701720|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701721|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701722|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701723|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701724|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701725|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701726|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701727|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701728|NCT00261495|E2|Reported Event|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
701729|NCT00261495|E1|Reported Event|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
701730|NCT00261443|B3|Baseline|Total|Total of all reporting groups
701731|NCT00261443|B2|Baseline|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701732|NCT00261443|B1|Baseline|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701733|NCT00261443|P3|Participant Flow|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701734|NCT00261443|P2|Participant Flow|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701735|NCT00261443|P1|Participant Flow|Pre-Randomized Participants|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701736|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701737|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701738|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701739|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701740|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701741|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701742|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701743|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701744|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701745|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701746|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701747|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
703850|NCT00252733|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
701748|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701749|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701750|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701751|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701752|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701753|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701754|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701755|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701756|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701757|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701758|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701759|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701760|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701761|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701762|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701763|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701764|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701765|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701766|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701767|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701768|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701769|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701770|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701771|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701772|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701773|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701774|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701775|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701776|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701777|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701778|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701779|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701780|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
703851|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
701781|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701782|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701783|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701784|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701785|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701786|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701787|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701788|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701789|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701790|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701791|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701792|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701793|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701794|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701795|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701796|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701797|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701798|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701799|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701800|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701801|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701802|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701803|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701804|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701805|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701806|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701807|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701808|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701809|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701810|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701811|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701812|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701813|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
703852|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
701814|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701815|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701816|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701817|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701818|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701819|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701820|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701821|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701822|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701823|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701824|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701825|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701826|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701827|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701828|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701829|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701830|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701831|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701832|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701833|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701834|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701835|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701836|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701837|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701838|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701839|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701840|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701841|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701842|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701843|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701844|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701845|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701846|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
703853|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
701847|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701848|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701849|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701850|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701851|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701852|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701853|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701854|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701855|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701856|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701857|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701858|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701859|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701860|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701861|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701862|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701863|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701864|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701865|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701866|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701867|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701868|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701869|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701870|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701871|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701872|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701873|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701874|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701875|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701876|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701877|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701878|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701879|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701880|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701881|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701882|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701883|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701884|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701885|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701886|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701887|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701888|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701889|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701890|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701891|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701892|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701893|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701894|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701895|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701896|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701897|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701898|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701899|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701900|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701901|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701902|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701903|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701904|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701905|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701906|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701907|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701908|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701909|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701910|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701911|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701912|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701913|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701914|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701915|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701916|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701917|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701918|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701919|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701920|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701921|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701922|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701923|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701924|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701925|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701926|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701927|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701928|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701929|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701930|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701931|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701932|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701933|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701934|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701935|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701936|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701937|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701938|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701939|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701940|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701941|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701942|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701943|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701944|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701945|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701946|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701947|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701948|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701949|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
702043|NCT00260429|O1|Outcome|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
701950|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701951|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701952|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701953|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701954|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701955|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701956|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701957|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701958|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701959|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701960|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701961|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701962|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701963|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701964|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701965|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701966|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701967|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701968|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701969|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701970|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701971|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701972|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701973|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701974|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
701975|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
701976|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701977|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701978|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701979|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701980|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701981|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701982|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701983|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
701984|NCT00261443|E5|Reported Event|Extension Phase Aripiprazole|Phase 4 (Extension Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701985|NCT00261443|E4|Reported Event|Extension Phase Placebo|Phase 4 (Extension Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701986|NCT00261443|E3|Reported Event|Double-Blind Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701987|NCT00261443|E2|Reported Event|Double-Blind Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701988|NCT00261443|E1|Reported Event|Single-Blind Aripiprazole|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
701989|NCT00260962|B3|Baseline|Total|Total of all reporting groups
701990|NCT00260962|B2|Baseline|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701991|NCT00260962|B1|Baseline|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701992|NCT00260962|P2|Participant Flow|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701993|NCT00260962|P1|Participant Flow|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701994|NCT00260962|O2|Outcome|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701995|NCT00260962|O1|Outcome|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701996|NCT00260962|O2|Outcome|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701997|NCT00260962|O1|Outcome|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
702044|NCT00260429|E2|Reported Event|Placebo|
702045|NCT00260429|E1|Reported Event|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
702046|NCT00260208|B3|Baseline|Total|Total of all reporting groups
702105|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702182|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
701998|NCT00260962|E2|Reported Event|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
701999|NCT00260962|E1|Reported Event|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
702000|NCT00260832|B3|Baseline|Total|Total of all reporting groups
702001|NCT00260832|B2|Baseline|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
702002|NCT00260832|B1|Baseline|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
702003|NCT00260832|P2|Participant Flow|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
702004|NCT00260832|P1|Participant Flow|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
702005|NCT00260832|O2|Outcome|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
702006|NCT00260832|O1|Outcome|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
702007|NCT00260832|E2|Reported Event|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
702008|NCT00260832|E1|Reported Event|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
702009|NCT00260689|B4|Baseline|Total|Total of all reporting groups
702010|NCT00260689|B3|Baseline|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
702011|NCT00260689|B2|Baseline|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
702012|NCT00260689|B1|Baseline|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
702013|NCT00260689|P3|Participant Flow|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
702014|NCT00260689|P2|Participant Flow|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
702015|NCT00260689|P1|Participant Flow|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
702016|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
702017|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
702018|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
702019|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
702020|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
702021|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
702022|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
702023|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
702024|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
702025|NCT00260689|E3|Reported Event|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
702026|NCT00260689|E2|Reported Event|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
702027|NCT00260689|E1|Reported Event|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
702028|NCT00260533|B3|Baseline|Total|Total of all reporting groups
702029|NCT00260533|B2|Baseline|Placebo|Placebo
702030|NCT00260533|B1|Baseline|Atomoxetine|Atomoxetine
702031|NCT00260533|P2|Participant Flow|Placebo|Placebo (matched capsules to atomoxetine)
702032|NCT00260533|P1|Participant Flow|Atomoxetine|Atomoxetine 40-100 mg per day
702033|NCT00260533|O2|Outcome|Placebo|Placebo
702034|NCT00260533|O1|Outcome|Atomoxetine|Atomoxetine
702035|NCT00260533|E2|Reported Event|Placebo|Placebo
702036|NCT00260533|E1|Reported Event|Atomoxetine|Atomoxetine
702037|NCT00260429|B3|Baseline|Total|Total of all reporting groups
702038|NCT00260429|B2|Baseline|Placebo|
702039|NCT00260429|B1|Baseline|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
702040|NCT00260429|P2|Participant Flow|Placebo|
702041|NCT00260429|P1|Participant Flow|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
702042|NCT00260429|O2|Outcome|Placebo|
702047|NCT00260208|B2|Baseline|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702048|NCT00260208|B1|Baseline|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702049|NCT00260208|P2|Participant Flow|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702050|NCT00260208|P1|Participant Flow|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702051|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702052|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702053|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702054|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702055|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702056|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702057|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702058|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702059|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702060|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
703854|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
702061|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702062|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702063|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702064|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702065|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702066|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702067|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702068|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702069|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702070|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702071|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702072|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702073|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702074|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
703855|NCT00252733|E2|Reported Event|Placebo|Placebo Comparator
702075|NCT00260208|E2|Reported Event|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
702076|NCT00260208|E1|Reported Event|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
702077|NCT00260195|B3|Baseline|Total|Total of all reporting groups
702078|NCT00260195|B2|Baseline|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
702079|NCT00260195|B1|Baseline|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
702080|NCT00260195|P2|Participant Flow|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
702081|NCT00260195|P1|Participant Flow|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
702082|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
702083|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
702084|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
702085|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
702086|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
702087|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
702088|NCT00260195|O2|Outcome|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
702089|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
702090|NCT00260195|E2|Reported Event|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
702091|NCT00260195|E1|Reported Event|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
702092|NCT00260065|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
702093|NCT00260065|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
702094|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
702095|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
702096|NCT00260065|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
702097|NCT00259857|B3|Baseline|Total|Total of all reporting groups
702098|NCT00259857|B2|Baseline|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702099|NCT00259857|B1|Baseline|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702100|NCT00259857|P2|Participant Flow|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702101|NCT00259857|P1|Participant Flow|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702102|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702103|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702104|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702106|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702107|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702108|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702109|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702110|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702111|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702112|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702113|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702114|NCT00259857|E2|Reported Event|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
702115|NCT00259857|E1|Reported Event|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
702116|NCT00259740|B3|Baseline|Total|Total of all reporting groups
702117|NCT00259740|B2|Baseline|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
702118|NCT00259740|B1|Baseline|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
702119|NCT00259740|P2|Participant Flow|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
702120|NCT00259740|P1|Participant Flow|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
702121|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
702122|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
702123|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
702124|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
702125|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
702126|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
702127|NCT00259740|E2|Reported Event|Denosumab 120 mg Q4W - Plateau-Phase|
702128|NCT00259740|E1|Reported Event|Denosumab 120 mg Q4W - Relapsed|
702129|NCT00259649|B1|Baseline|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
702130|NCT00259649|P1|Participant Flow|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
702131|NCT00259649|O1|Outcome|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
702132|NCT00259649|E1|Reported Event|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
702133|NCT00259610|B5|Baseline|Total|Total of all reporting groups
702134|NCT00259610|B4|Baseline|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702135|NCT00259610|B3|Baseline|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
702136|NCT00259610|B2|Baseline|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702137|NCT00259610|B1|Baseline|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
703856|NCT00252733|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
702138|NCT00259610|P4|Participant Flow|MTX + Placebo SSZ + HCQ(ST)|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
702139|NCT00259610|P3|Participant Flow|MTX + Placebo Entaneracept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection
702140|NCT00259610|P2|Participant Flow|MTX+ Active SSZ +HCQ|methotrexate (MTX)20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
702141|NCT00259610|P1|Participant Flow|MTX + Active Etanercept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection
702142|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702143|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
702144|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702145|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
702146|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702147|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
702148|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702149|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
702150|NCT00259610|E4|Reported Event|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702151|NCT00259610|E3|Reported Event|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
702152|NCT00259610|E2|Reported Event|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
702153|NCT00259610|E1|Reported Event|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
702154|NCT00259298|B1|Baseline|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702155|NCT00259298|P1|Participant Flow|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702156|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702157|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702158|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702159|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702160|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702161|NCT00259298|E1|Reported Event|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
702162|NCT00259285|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
702163|NCT00259285|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
702164|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
702165|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
702166|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
702167|NCT00259285|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
702168|NCT00259272|B5|Baseline|Total|Total of all reporting groups
702169|NCT00259272|B4|Baseline|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702170|NCT00259272|B3|Baseline|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702171|NCT00259272|B2|Baseline|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702172|NCT00259272|B1|Baseline|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702173|NCT00259272|P4|Participant Flow|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702174|NCT00259272|P3|Participant Flow|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702175|NCT00259272|P2|Participant Flow|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702176|NCT00259272|P1|Participant Flow|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702177|NCT00259272|O3|Outcome|Cumulative|
702178|NCT00259272|O2|Outcome|Proportion|
702179|NCT00259272|O1|Outcome|Eigen Value|
702180|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702181|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
703220|NCT00255190|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
702183|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702184|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702185|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702186|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702187|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702188|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702189|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702190|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702191|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702192|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702193|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702194|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702195|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702196|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
702197|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
702198|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
702199|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
702200|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
702201|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
702202|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
702203|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
702204|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
702205|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
702206|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
702207|NCT00259272|O1|Outcome|Thymic Hypo-Reactive|As assessed by the investigator according to his clinical experience.
702208|NCT00259272|O1|Outcome|Weight Gain Subgroup|Patients who gained more than 7% of body weight during the study.
702209|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702210|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702211|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702212|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702213|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702214|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702215|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702216|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702217|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702218|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702219|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702220|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702221|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702222|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702223|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702224|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702225|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
703857|NCT00252720|B3|Baseline|Total|Total of all reporting groups
702226|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702227|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702228|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702229|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702230|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702231|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702232|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702233|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702234|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702235|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702236|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702237|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702238|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702239|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702240|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702241|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702242|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702243|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702244|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702245|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
702246|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702247|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
702248|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
702249|NCT00259272|E1|Reported Event|Olanzapine|Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
702250|NCT00259090|B4|Baseline|Total|Total of all reporting groups
702251|NCT00259090|B3|Baseline|Anastrozole|Anastrozole 1 mg once daily tablet
702252|NCT00259090|B2|Baseline|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
702253|NCT00259090|B1|Baseline|Fulvestrant|Fulvestrant 500 mg once monthly injection
702254|NCT00259090|P3|Participant Flow|Anastrozole|Anastrozole 1 mg once daily tablet
702255|NCT00259090|P2|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
702256|NCT00259090|P1|Participant Flow|Fulvestrant|Fulvestrant 500 mg once monthly injection
702257|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
702258|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
702259|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
702260|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
702261|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
702262|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
702263|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
702264|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
702265|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
702266|NCT00259090|E3|Reported Event|Anastrozole|Anastrozole 1 mg once daily tablet
702267|NCT00259090|E2|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
702268|NCT00259090|E1|Reported Event|Fulvestrant|Fulvestrant 500 mg once monthly injection
702269|NCT00259012|B3|Baseline|Total|Total of all reporting groups
702270|NCT00259012|B2|Baseline|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702271|NCT00259012|B1|Baseline|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702272|NCT00259012|P2|Participant Flow|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702273|NCT00259012|P1|Participant Flow|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702274|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702275|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702276|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702277|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702278|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702279|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702280|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702281|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702282|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702283|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702284|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702285|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702286|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702287|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702288|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702289|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702290|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702291|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702292|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702324|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702293|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702294|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702295|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702296|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702297|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702298|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702299|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702300|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702301|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702302|NCT00259012|E2|Reported Event|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
702303|NCT00259012|E1|Reported Event|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
702304|NCT00258908|B1|Baseline|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
702305|NCT00258908|P1|Participant Flow|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
702306|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
702307|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
702308|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
702309|NCT00258908|E1|Reported Event|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
702310|NCT00258895|B3|Baseline|Total|Total of all reporting groups
702311|NCT00258895|B2|Baseline|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702312|NCT00258895|B1|Baseline|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702313|NCT00258895|P2|Participant Flow|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702314|NCT00258895|P1|Participant Flow|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702315|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702316|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702317|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702318|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702319|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702320|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702321|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702322|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702323|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702325|NCT00258895|E2|Reported Event|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
702326|NCT00258895|E1|Reported Event|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
702327|NCT00258882|B3|Baseline|Total|Total of all reporting groups
702328|NCT00258882|B2|Baseline|Control Groups|Non-pregnant individuals matched by age to individuals who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
702329|NCT00258882|B1|Baseline|Adacel Vaccine Group|"Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.~Each non-pregnant recipient served as their own control for evaluation of acute events. Rates of events occurring during Day 0 to 60 following vaccination were compared to rates of events occurring during Day 61 to 120 following vaccination (Short-term surveillance)"
702330|NCT00258882|P2|Participant Flow|Control Groups|For each pregnant individual receiving Adacel vaccine, 3 control individuals not given Adacel vaccine were matched on age and month of their first positive pregnancy test. For non-pregnant individuals, age-matched individuals were identified who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
702331|NCT00258882|P1|Participant Flow|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.
702332|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
702333|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination
702334|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
702335|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination.
702336|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
702337|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
702338|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
702339|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
702340|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
702341|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
702342|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
702343|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
702344|NCT00258882|E1|Reported Event|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period. They are sub-grouped as those pregnant at the time of vaccination with Adacel or who became pregnant within 28 days after vaccination and other recipients are classified by age at vaccination.
702345|NCT00258856|B5|Baseline|Total|Total of all reporting groups
702346|NCT00258856|B4|Baseline|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
702347|NCT00258856|B3|Baseline|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
702348|NCT00258856|B2|Baseline|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
702349|NCT00258856|B1|Baseline|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
702350|NCT00258856|P4|Participant Flow|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
702351|NCT00258856|P3|Participant Flow|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
702352|NCT00258856|P2|Participant Flow|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
702353|NCT00258856|P1|Participant Flow|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
702354|NCT00258856|O4|Outcome|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
702355|NCT00258856|O3|Outcome|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
702356|NCT00258856|O2|Outcome|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
703858|NCT00252720|B2|Baseline|Placebo|Placebo Comparator
702357|NCT00258856|O1|Outcome|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
702358|NCT00258856|E4|Reported Event|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
702359|NCT00258856|E3|Reported Event|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
702360|NCT00258856|E2|Reported Event|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
702361|NCT00258856|E1|Reported Event|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
702362|NCT00258830|B3|Baseline|Total|Total of all reporting groups
702363|NCT00258830|B2|Baseline|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702364|NCT00258830|B1|Baseline|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702365|NCT00258830|P2|Participant Flow|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702366|NCT00258830|P1|Participant Flow|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702367|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702368|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702369|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702370|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702371|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702372|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702373|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702374|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702375|NCT00258830|E2|Reported Event|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702376|NCT00258830|E1|Reported Event|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
702377|NCT00258817|B3|Baseline|Total|Total of all reporting groups
702378|NCT00258817|B2|Baseline|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
702379|NCT00258817|B1|Baseline|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
702380|NCT00258817|P2|Participant Flow|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
702381|NCT00258817|P1|Participant Flow|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
702382|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
702383|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
702384|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
702385|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
702386|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
702387|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
702388|NCT00258817|E2|Reported Event|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
702389|NCT00258817|E1|Reported Event|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
702390|NCT00258674|B4|Baseline|Total|Total of all reporting groups
702391|NCT00258674|B3|Baseline|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702392|NCT00258674|B2|Baseline|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702393|NCT00258674|B1|Baseline|Claims|Physician feedback of patient process measures using Medicare claims data
702394|NCT00258674|P3|Participant Flow|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702395|NCT00258674|P2|Participant Flow|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702396|NCT00258674|P1|Participant Flow|Claims|Physician feedback of patient process measures using Medicare claims data
703859|NCT00252720|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
702397|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702398|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702399|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702400|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702401|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702402|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702403|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702404|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702405|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702406|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702407|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702408|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702409|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702410|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702411|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702412|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702413|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702414|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702415|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702416|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702417|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702418|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702419|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702420|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702421|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702422|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702423|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702424|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702425|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702426|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702427|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702428|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702429|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702430|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702431|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702432|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702433|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702434|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702435|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702436|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
703860|NCT00252720|P2|Participant Flow|Placebo|Placebo Comparator
702437|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702438|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702439|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702440|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702441|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702442|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702443|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702444|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702445|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702446|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702447|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
702448|NCT00258674|E3|Reported Event|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
702449|NCT00258674|E2|Reported Event|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
702450|NCT00258674|E1|Reported Event|Claims|Physician feedback of patient process measures using Medicare claims data
702451|NCT00258440|B4|Baseline|Total|Total of all reporting groups
702452|NCT00258440|B3|Baseline|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
702453|NCT00258440|B2|Baseline|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
702454|NCT00258440|B1|Baseline|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
702455|NCT00258440|P3|Participant Flow|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
702456|NCT00258440|P2|Participant Flow|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
702457|NCT00258440|P1|Participant Flow|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
702458|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
702459|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
702460|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
702461|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
702462|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
702463|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
702464|NCT00258440|E3|Reported Event|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
702465|NCT00258440|E2|Reported Event|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
702466|NCT00258440|E1|Reported Event|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
702467|NCT00258362|B1|Baseline|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.
702582|NCT00257920|E1|Reported Event|Zemplar|6mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2.
702468|NCT00258362|P1|Participant Flow|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
702469|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
702470|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
702471|NCT00258362|E1|Reported Event|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
702472|NCT00258349|B1|Baseline|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
702473|NCT00258349|P1|Participant Flow|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
702474|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
702475|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
702476|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|"Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;~Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle"
702477|NCT00258349|E2|Reported Event|Vorinostat +Trastuzumab (Phase I)|phase I patients for identify maximum tolerated dose
702478|NCT00258349|E1|Reported Event|Vorinostat +Trastuzumab (Phase II)|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
702479|NCT00258310|B1|Baseline|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
702480|NCT00258310|P1|Participant Flow|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
702481|NCT00258310|O1|Outcome|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
702482|NCT00258310|E1|Reported Event|Capcitabine|"Caoecutabube 1000mg/day for one year~capecitabine~adjuvant therapy"
702483|NCT00258206|B1|Baseline|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
702484|NCT00258206|P1|Participant Flow|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
702485|NCT00258206|O1|Outcome|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
702486|NCT00258206|E1|Reported Event|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
702487|NCT00258154|B3|Baseline|Total|Total of all reporting groups
702488|NCT00258154|B2|Baseline|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702489|NCT00258154|B1|Baseline|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702490|NCT00258154|P2|Participant Flow|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702491|NCT00258154|P1|Participant Flow|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702492|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702493|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702494|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702495|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702496|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702497|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702498|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702499|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702500|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702501|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702583|NCT00257894|B3|Baseline|Total|Total of all reporting groups
702502|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702503|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702504|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702505|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702506|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702507|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702508|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702509|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702510|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702511|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702512|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702513|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702514|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702515|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702516|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702517|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702518|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702519|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702520|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702521|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702522|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702523|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702524|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702525|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702526|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702527|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702528|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702529|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702530|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702531|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702532|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702533|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702534|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702535|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702536|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702537|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702538|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702539|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
704437|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
702540|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702541|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702542|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702543|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702544|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702545|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702546|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702547|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702548|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702549|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702550|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702551|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702552|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702553|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702554|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702555|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702556|NCT00258154|E2|Reported Event|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
702557|NCT00258154|E1|Reported Event|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
702558|NCT00258011|B1|Baseline|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
702559|NCT00258011|P1|Participant Flow|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
702560|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
702561|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
702562|NCT00258011|E1|Reported Event|Aldurazyme|Aldurazyme
702563|NCT00257933|B3|Baseline|Total|Total of all reporting groups
702564|NCT00257933|B2|Baseline|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
702565|NCT00257933|B1|Baseline|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
702566|NCT00257933|P2|Participant Flow|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
702567|NCT00257933|P1|Participant Flow|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
702568|NCT00257933|O2|Outcome|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
702569|NCT00257933|O1|Outcome|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
702570|NCT00257933|E2|Reported Event|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
702571|NCT00257933|E1|Reported Event|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
702572|NCT00257920|B3|Baseline|Total|Total of all reporting groups
702573|NCT00257920|B2|Baseline|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
702574|NCT00257920|B1|Baseline|Zemplar First|6 mcg Zemplar Injection QOD for 6 doses in Period 1 and 3.6 mcg Hectorol Injection QOD for 6 doses in Period 2
702575|NCT00257920|P2|Participant Flow|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
702576|NCT00257920|P1|Participant Flow|Zemplar First|6 mcg Zemplar Injection every other day (QOD) for 6 doses in Period 1 and 3.6 mcg Hectorol Injection for 6 doses in Period 2
702577|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
702578|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
702579|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2.
702580|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
702581|NCT00257920|E2|Reported Event|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
703861|NCT00252720|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
702585|NCT00257894|B1|Baseline|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
702586|NCT00257894|P2|Participant Flow|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
702587|NCT00257894|P1|Participant Flow|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
702588|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
702589|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
702590|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
702591|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
702592|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
702593|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
702594|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
702595|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
702596|NCT00257894|E2|Reported Event|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
702597|NCT00257894|E1|Reported Event|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
702598|NCT00257686|B7|Baseline|Total|Total of all reporting groups
702599|NCT00257686|B6|Baseline|Pravastatin 40 mg|Pravastatin 40 mg once daily
702600|NCT00257686|B5|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
702601|NCT00257686|B4|Baseline|Pravastatin 20 mg|Pravastatin 20 mg once daily
702602|NCT00257686|B3|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
702603|NCT00257686|B2|Baseline|Pravastatin 10 mg|Pravastatin 10 mg once daily
702604|NCT00257686|B1|Baseline|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
702605|NCT00257686|P6|Participant Flow|Pravastatin 40 mg|Pravastatin 40 mg once daily
702606|NCT00257686|P5|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
702607|NCT00257686|P4|Participant Flow|Pravastatin 20 mg|Pravastatin 20 mg once daily
702608|NCT00257686|P3|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
702609|NCT00257686|P2|Participant Flow|Pravastatin 10 mg|Pravastatin 10 mg once daily
702610|NCT00257686|P1|Participant Flow|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
702611|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
702612|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
702613|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
702614|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
702615|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
702616|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
702617|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
702618|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
702619|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
702620|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
702621|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
702622|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
702623|NCT00257686|E6|Reported Event|Pravastatin 40 mg|Pravastatin 40 mg once daily
702624|NCT00257686|E5|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
702625|NCT00257686|E4|Reported Event|Pravastatin 20 mg|Pravastatin 20 mg once daily
702626|NCT00257686|E3|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
702627|NCT00257686|E2|Reported Event|Pravastatin 10 mg|Pravastatin 10 mg once daily
702628|NCT00257686|E1|Reported Event|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
702629|NCT00257660|B3|Baseline|Total|Total of all reporting groups
702630|NCT00257660|B2|Baseline|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702631|NCT00257660|B1|Baseline|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702632|NCT00257660|P2|Participant Flow|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
703862|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
702633|NCT00257660|P1|Participant Flow|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702634|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702635|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702636|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702637|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702638|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702639|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702640|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702641|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702642|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702643|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702644|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702645|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702646|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702647|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702648|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702649|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702650|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702651|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702652|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702653|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702654|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702655|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702656|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702657|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702658|NCT00257660|E2|Reported Event|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702659|NCT00257660|E1|Reported Event|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
702660|NCT00257608|B3|Baseline|Total|Total of all reporting groups
702661|NCT00257608|B2|Baseline|Bevacizumab + Erlotinib|Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily
702662|NCT00257608|B1|Baseline|Bevacizumab + Placebo|Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily
702663|NCT00257608|P3|Participant Flow|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
702664|NCT00257608|P2|Participant Flow|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
702665|NCT00257608|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.
702666|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
702667|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
702668|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
702669|NCT00257608|O1|Outcome|Bevacizumab + Placebo|"Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib.~orally daily."
703221|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
702670|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
702671|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
702672|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
702673|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
702674|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
702675|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
702676|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
702677|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
702678|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
702679|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
702680|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
702681|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
702682|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
702683|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration-time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
702684|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
702685|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
702686|NCT00257608|E2|Reported Event|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
702687|NCT00257608|E1|Reported Event|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
702688|NCT00257556|B3|Baseline|Total|Total of all reporting groups
702689|NCT00257556|B2|Baseline|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702690|NCT00257556|B1|Baseline|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702691|NCT00257556|P2|Participant Flow|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702692|NCT00257556|P1|Participant Flow|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702693|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702694|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702695|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702696|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702697|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702698|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702699|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702700|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702701|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702702|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702703|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702705|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702706|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702707|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702708|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702709|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702710|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702711|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702712|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702713|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702714|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702715|NCT00257556|E2|Reported Event|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
702716|NCT00257556|E1|Reported Event|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
702717|NCT00257322|B1|Baseline|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
702718|NCT00257322|P1|Participant Flow|Chemo Therapy and GM-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
702719|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
702720|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
702721|NCT00257322|E1|Reported Event|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
702722|NCT00257309|B3|Baseline|Total|Total of all reporting groups
702723|NCT00257309|B2|Baseline|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
702724|NCT00257309|B1|Baseline|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
702725|NCT00257309|P2|Participant Flow|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
702726|NCT00257309|P1|Participant Flow|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
702727|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
702728|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
702729|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
702730|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
702731|NCT00257309|E2|Reported Event|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
702732|NCT00257309|E1|Reported Event|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
702733|NCT00257192|B3|Baseline|Total|Total of all reporting groups
702734|NCT00257192|B2|Baseline|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702735|NCT00257192|B1|Baseline|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702736|NCT00257192|P2|Participant Flow|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702737|NCT00257192|P1|Participant Flow|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702738|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702739|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702799|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702740|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702741|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702742|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702743|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702744|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702745|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702746|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702747|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702748|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702749|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702750|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702751|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702752|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702800|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702801|NCT00257010|E1|Reported Event|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702753|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702754|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702755|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702756|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702757|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702758|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702759|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702760|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702761|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702762|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702763|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702764|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702765|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702802|NCT00256997|B3|Baseline|Total|Total of all reporting groups
702803|NCT00256997|B2|Baseline|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702766|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702767|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702768|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702769|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702770|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702771|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702772|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702773|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702774|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702775|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702776|NCT00257192|E2|Reported Event|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702777|NCT00257192|E1|Reported Event|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
702778|NCT00257166|B3|Baseline|Total|Total of all reporting groups
702779|NCT00257166|B2|Baseline|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
702804|NCT00256997|B1|Baseline|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702805|NCT00256997|P2|Participant Flow|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702780|NCT00257166|B1|Baseline|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
702781|NCT00257166|P2|Participant Flow|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
702782|NCT00257166|P1|Participant Flow|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
702783|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
702784|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
702785|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
702786|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
702787|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
702788|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
702789|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
702790|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
702791|NCT00257166|E2|Reported Event|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
702792|NCT00257166|E1|Reported Event|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
702793|NCT00257010|B1|Baseline|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702794|NCT00257010|P1|Participant Flow|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702795|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702796|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702797|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702798|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
702806|NCT00256997|P1|Participant Flow|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702807|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702808|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702809|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702810|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702811|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702812|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702813|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702814|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702815|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702816|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702817|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702818|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702819|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702820|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702821|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702822|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702823|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702824|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702825|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702826|NCT00256997|O1|Outcome|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
702827|NCT00256997|E2|Reported Event|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
702828|NCT00256997|E1|Reported Event|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
703184|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
704438|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
702829|NCT00256984|B1|Baseline|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702830|NCT00256984|P1|Participant Flow|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702831|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702832|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702833|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702834|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702835|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702836|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702837|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702838|NCT00256984|E1|Reported Event|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
702839|NCT00256867|B9|Baseline|Total|Total of all reporting groups
702840|NCT00256867|B8|Baseline|SIMV 80mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702841|NCT00256867|B7|Baseline|SIMV 40mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702842|NCT00256867|B6|Baseline|RSG 8mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702843|NCT00256867|B5|Baseline|RSG 4mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702844|NCT00256867|B4|Baseline|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702845|NCT00256867|B3|Baseline|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702846|NCT00256867|B2|Baseline|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702847|NCT00256867|B1|Baseline|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702848|NCT00256867|P8|Participant Flow|SIMV 80mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702849|NCT00256867|P7|Participant Flow|SIMV 40mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702850|NCT00256867|P6|Participant Flow|RSG 8mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702851|NCT00256867|P5|Participant Flow|RSG 4mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702852|NCT00256867|P4|Participant Flow|FDC 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702853|NCT00256867|P3|Participant Flow|FDC 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg from Week 6 till Week 16.
702854|NCT00256867|P2|Participant Flow|FDC 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702855|NCT00256867|P1|Participant Flow|Fixed Dose Combination (FDC) 4/40 Milligram (mg)|Participants received FDC of rosiglitazone (RSG) 4.0 mg and simvastatin (SIMV) 40 mg (FDC 4/40) and matching placebo once a day for 16 weeks. In case of the participants who had Low Density Lipoprotein-cholesterol (LDL-c) > 130 milligram per deciliter (mg/dL) at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg from Week 6 till Week 16.
702856|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702857|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702858|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702859|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702860|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702861|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702862|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702863|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702864|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702865|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702866|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702867|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702868|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702869|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702870|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702871|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702872|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702873|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702874|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702875|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702876|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702877|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702878|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702879|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702880|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702881|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702882|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702883|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702884|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702885|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702886|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
703185|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703186|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
702887|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702888|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702889|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702890|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702891|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702892|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702893|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702894|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702895|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702896|NCT00256867|O2|Outcome|All FDC RSG/SIMV Groups|In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702897|NCT00256867|O1|Outcome|All SIM Monotherapy Groups|In this arm, all the participants were pooled who received SIM 40 and 80 mg, and matching placebo once a day for 16 weeks.
702898|NCT00256867|O2|Outcome|All FDC RSG/SIMV Groups|In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702899|NCT00256867|O1|Outcome|All SIM Monotherapy Groups|In this arm, all the participants were pooled who received SIM 40 and 80 mg, and matching placebo once a day for 16 weeks.
702900|NCT00256867|O2|Outcome|All FDC RSG/SIMV Groups|In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702901|NCT00256867|O1|Outcome|All RSG Monotherapy Groups|In this arm, all the participants were pooled who received RSG 4 and 8mg, and matching placebo once a day for 16 weeks.
702902|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702903|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702904|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702905|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702906|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702907|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702908|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702909|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702910|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702911|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702912|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702913|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702914|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702915|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702916|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
703863|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
702917|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702918|NCT00256867|O8|Outcome|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702919|NCT00256867|O7|Outcome|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702920|NCT00256867|O6|Outcome|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702921|NCT00256867|O5|Outcome|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702922|NCT00256867|O4|Outcome|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702923|NCT00256867|O3|Outcome|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702924|NCT00256867|O2|Outcome|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702925|NCT00256867|O1|Outcome|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702926|NCT00256867|O2|Outcome|All FDC RSG/SIMV Groups|In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702927|NCT00256867|O1|Outcome|All SIM Monotherapy Groups|In this arm, all the participants were pooled who received SIM 40 and 80 mg, and matching placebo once a day for 16 weeks.
702928|NCT00256867|O2|Outcome|All RSG Monotherapy Groups|In this arm, all the participants were pooled who received RSG 4 and 8mg, and matching placebo once a day for 16 weeks.
702929|NCT00256867|O1|Outcome|All FDC RSG/SIMV Groups|In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702930|NCT00256867|E8|Reported Event|SIMV 80 mg|Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.
702931|NCT00256867|E7|Reported Event|SIMV 40 mg|Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.
702932|NCT00256867|E6|Reported Event|RSG 8 mg|Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.
702933|NCT00256867|E5|Reported Event|RSG 4 mg|Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.
702934|NCT00256867|E4|Reported Event|FDC RSG/SIMV 8/80 mg|Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.
702935|NCT00256867|E3|Reported Event|FDC RSG/SIMV 8/40 mg|Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702936|NCT00256867|E2|Reported Event|FDC RSG/SIMV 4/80 mg|Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.
702937|NCT00256867|E1|Reported Event|FDC RSG/SIMV 4/40 mg|Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c >130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.
702938|NCT00256750|B4|Baseline|Total|Total of all reporting groups
702939|NCT00256750|B3|Baseline|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702940|NCT00256750|B2|Baseline|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702941|NCT00256750|B1|Baseline|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702942|NCT00256750|P3|Participant Flow|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702943|NCT00256750|P2|Participant Flow|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702944|NCT00256750|P1|Participant Flow|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702945|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703864|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
702946|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702947|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702948|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702949|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702950|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702951|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702952|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702953|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702954|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702955|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702956|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702957|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702958|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702959|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702960|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702961|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702962|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702963|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702964|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702965|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702966|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702967|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702968|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702969|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702970|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702971|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702972|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702973|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702974|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702975|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702976|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702977|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702978|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702979|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702980|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702981|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702982|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702983|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702984|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702985|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702986|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702987|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702988|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702989|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702990|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702991|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702992|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702993|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702994|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702995|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702996|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
702997|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
704439|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
702998|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
702999|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703000|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703001|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703002|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703003|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703004|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703005|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703006|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703007|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703008|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703009|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703010|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703011|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703012|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703013|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703014|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703015|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703016|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703017|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703018|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703019|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703020|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703021|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703022|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703023|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703187|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703024|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703025|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703026|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703027|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703028|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703029|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703030|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703031|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703032|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703033|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703034|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703035|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703036|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703037|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703038|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703039|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703040|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703041|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703042|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703043|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703044|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703045|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703046|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703047|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703048|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703049|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703188|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
703189|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703050|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703051|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703052|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703053|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703054|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703055|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703056|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703057|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703058|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703059|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703060|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703061|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703062|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703063|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703064|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703065|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703066|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703067|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703068|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703069|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703070|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703071|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703072|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703073|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703074|NCT00256750|E3|Reported Event|Belatacept - MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703075|NCT00256750|E2|Reported Event|Belatacept - LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
703190|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
703191|NCT00255970|E2|Reported Event|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703076|NCT00256750|E1|Reported Event|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
703077|NCT00256724|B3|Baseline|Total|Total of all reporting groups
703078|NCT00256724|B2|Baseline|Active ITD|active impedance threshold device
703079|NCT00256724|B1|Baseline|Sham ITD|sham Impedance Threshold Device
703080|NCT00256724|P2|Participant Flow|Active ITD|active impedance threshold device
703081|NCT00256724|P1|Participant Flow|Sham ITD|sham Impedance Threshold Device
703082|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
703083|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
703084|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
703085|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
703086|NCT00256724|E2|Reported Event|Active ITD|active impedance threshold device
703087|NCT00256724|E1|Reported Event|Sham ITD|sham Impedance Threshold Device
703088|NCT00256698|B3|Baseline|Total|Total of all reporting groups
703089|NCT00256698|B2|Baseline|Anastrozole|Anastrozole 1 mg
703090|NCT00256698|B1|Baseline|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703091|NCT00256698|P2|Participant Flow|Anastrozole|Anastrozole 1 mg
703092|NCT00256698|P1|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703093|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
703094|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703095|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
703096|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703097|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
703098|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703099|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
703100|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703101|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
703102|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703103|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
703104|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703105|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
703106|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703107|NCT00256698|E2|Reported Event|Anastrozole|Anastrozole 1 mg
703108|NCT00256698|E1|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
703109|NCT00256308|B1|Baseline|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703110|NCT00256308|P1|Participant Flow|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703111|NCT00256308|O1|Outcome|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703112|NCT00256308|O1|Outcome|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703113|NCT00256308|O1|Outcome|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703114|NCT00256308|O1|Outcome|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703115|NCT00256308|O1|Outcome|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703116|NCT00256308|E1|Reported Event|Oxaliplatin|Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
703117|NCT00256295|B1|Baseline|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
703118|NCT00256295|P1|Participant Flow|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
703119|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
703120|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
703121|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
703192|NCT00255970|E1|Reported Event|Regenafil|Regenafil graft
703122|NCT00256295|E1|Reported Event|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
703123|NCT00256282|B1|Baseline|Docetaxel and Vinorelbine Plus Sargramostim|The DVS regimen consisted of docetaxel 40 mg/m2 IV over 1 hour, vinorelbine 30 mg/m2 IV over 6 to 10 minutes on day 1, every 14 days, and GM-CSF, 250 mg/m2 SC on days 2 to 12. Patients received a cycle of this regimen every two weeks.
703124|NCT00256282|P1|Participant Flow|Docetaxel and Vinorelbine Plus Sargramostim|"Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ)~Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days~Docetaxel: 40mg/m2 IV over 1 hour every 14 days~Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days"
703125|NCT00256282|O1|Outcome|Docetaxel and Vinorelbine Plus Sargramostim|"Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ)~Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days~Docetaxel: 40mg/m2 IV over 1 hour every 14 days~Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days"
703126|NCT00256282|O1|Outcome|Docetaxel and Vinorelbine Plus Sargramostim|"Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ)~Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days~Docetaxel: 40mg/m2 IV over 1 hour every 14 days~Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days"
703127|NCT00256282|E1|Reported Event|Docetaxel and Vinorelbine Plus Sargramostim|"Docetaxel (40 mg.m2 IV), Vinorelbine (30 mg/m2 IV), and Sargramostim 250 mcg/m2 subcutaneous (SQ)~Vinorelbine: 30 mg/m2 IV over 6-10 min every 14 days~Docetaxel: 40mg/m2 IV over 1 hour every 14 days~Sargramostim: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days"
703128|NCT00256243|B1|Baseline|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
703129|NCT00256243|P1|Participant Flow|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
703130|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
703131|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
703132|NCT00256243|E1|Reported Event|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
703133|NCT00256204|B5|Baseline|Total|Total of all reporting groups
703134|NCT00256204|B4|Baseline|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
703135|NCT00256204|B3|Baseline|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
703136|NCT00256204|B2|Baseline|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
703137|NCT00256204|B1|Baseline|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
703138|NCT00256204|P4|Participant Flow|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
703139|NCT00256204|P3|Participant Flow|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
703140|NCT00256204|P2|Participant Flow|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
703141|NCT00256204|P1|Participant Flow|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
703142|NCT00256204|O4|Outcome|2mg Delayed Start|+1mg Delayed Start: see 1st column
703143|NCT00256204|O3|Outcome|2mg Early Start|2mg early start active treatment arm (72 weeks active)
703144|NCT00256204|O2|Outcome|1mg Early Start|1mg early start active treatment arm (72 weeks active)
703145|NCT00256204|O1|Outcome|1mg Delayed Start|+ 2 mg Delayed Start: 36 week combined placebo group.
703146|NCT00256204|O4|Outcome|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
703147|NCT00256204|O3|Outcome|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
703148|NCT00256204|O2|Outcome|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
703149|NCT00256204|O1|Outcome|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
703150|NCT00256204|E3|Reported Event|2mg Active Treatment|2mg Active & 2mg Delayed. This group includes those patients who received 2mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 2mg Delayed start treatment arm (36 weeks active treatment)
703151|NCT00256204|E2|Reported Event|1mg Active Treatment|1mg Active & 1mg Delayed. This group includes those patients who received 1mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 1mg Delayed start treatment arm (36 weeks active treatment)
703152|NCT00256204|E1|Reported Event|Placebo Combined Group|1mg & 2mg combined placebo group includes those patients in 1mg Delayed start and the 2mg Delayed start arms who received placebo for the first 36 weeks.
703153|NCT00256126|B3|Baseline|Total|Total of all reporting groups
703154|NCT00256126|B2|Baseline|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703155|NCT00256126|B1|Baseline|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703156|NCT00256126|P2|Participant Flow|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703157|NCT00256126|P1|Participant Flow|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703158|NCT00256126|O2|Outcome|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703159|NCT00256126|O1|Outcome|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703160|NCT00256126|O2|Outcome|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703161|NCT00256126|O1|Outcome|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703162|NCT00256126|O2|Outcome|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703163|NCT00256126|O1|Outcome|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703164|NCT00256126|O2|Outcome|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703165|NCT00256126|O1|Outcome|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703166|NCT00256126|O2|Outcome|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703167|NCT00256126|O1|Outcome|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703168|NCT00256126|O2|Outcome|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703169|NCT00256126|O1|Outcome|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703170|NCT00256126|E2|Reported Event|Growth Hormone Deficiency (GHD)|Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
703171|NCT00256126|E1|Reported Event|Turner Syndrome (TS)|Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month.
703172|NCT00255970|B3|Baseline|Total|Total of all reporting groups
703173|NCT00255970|B2|Baseline|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703174|NCT00255970|B1|Baseline|Regenafil|Regenafil graft
703175|NCT00255970|P2|Participant Flow|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703176|NCT00255970|P1|Participant Flow|Regenafil|Regenafil graft
703177|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703178|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
703179|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703180|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
703181|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703182|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
703183|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
703194|NCT00255840|B2|Baseline|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703195|NCT00255840|B1|Baseline|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703196|NCT00255840|P2|Participant Flow|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703197|NCT00255840|P1|Participant Flow|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703198|NCT00255840|O2|Outcome|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703199|NCT00255840|O1|Outcome|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703200|NCT00255840|E2|Reported Event|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703201|NCT00255840|E1|Reported Event|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
703202|NCT00255723|B3|Baseline|Total|Total of all reporting groups
703203|NCT00255723|B2|Baseline|Arm B|Augmented ICE x 2 cycles (2 risk factors)
703204|NCT00255723|B1|Baseline|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
703205|NCT00255723|P2|Participant Flow|Arm B|Augmented ICE x 2 cycles (2 risk factors)
703206|NCT00255723|P1|Participant Flow|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
703207|NCT00255723|O2|Outcome|Arm B|Augmented ICE x 2 cycles (2 risk factors)
703208|NCT00255723|O1|Outcome|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
703209|NCT00255723|E2|Reported Event|Arm B|Augmented ICE x 2 cycles (2 risk factors)
703210|NCT00255723|E1|Reported Event|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
703211|NCT00255684|B1|Baseline|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
703212|NCT00255684|P1|Participant Flow|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
703213|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
703214|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
703215|NCT00255684|E1|Reported Event|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
703216|NCT00255190|B3|Baseline|Total|Total of all reporting groups
703217|NCT00255190|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703218|NCT00255190|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703219|NCT00255190|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703222|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703223|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703224|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703225|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703226|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703227|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703228|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703229|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703230|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703231|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703232|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703233|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703234|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703235|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703236|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703237|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703238|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703239|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703240|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703241|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703242|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703243|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703244|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703245|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703246|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703247|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703248|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703249|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703250|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703251|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703252|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703253|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703254|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703255|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703256|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703257|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703258|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703259|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703260|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703261|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703262|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703263|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703264|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703265|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703266|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703267|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703268|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703269|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703270|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703271|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703272|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703273|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703274|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703275|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703276|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703277|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703278|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703279|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703280|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703281|NCT00255190|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
703282|NCT00255190|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
703283|NCT00255177|B5|Baseline|Total|Total of all reporting groups
703284|NCT00255177|B4|Baseline|VGX-410 300mg Twice Daily|
703285|NCT00255177|B3|Baseline|VGX-410 300mg Daily|
703286|NCT00255177|B2|Baseline|VGX-410 150mg Daily|
703287|NCT00255177|B1|Baseline|Placebo|
703288|NCT00255177|P4|Participant Flow|VGX-410 300mg Twice Daily|
703289|NCT00255177|P3|Participant Flow|VGX-410 300mg Daily|
703290|NCT00255177|P2|Participant Flow|VGX-410 150mg Daily|
703291|NCT00255177|P1|Participant Flow|Placebo|
703292|NCT00255177|O4|Outcome|VGX-410 300mg Twice Daily|
703293|NCT00255177|O3|Outcome|VGX-410 300mg Daily|
703294|NCT00255177|O2|Outcome|VGX-410 150mg Daily|
703295|NCT00255177|O1|Outcome|Placebo|
703296|NCT00255177|E4|Reported Event|VGX-410 300mg Twice Daily|
703297|NCT00255177|E3|Reported Event|VGX-410 300mg Daily|
703298|NCT00255177|E2|Reported Event|VGX-410 150mg Daily|
703299|NCT00255177|E1|Reported Event|Placebo|
703300|NCT00255164|B4|Baseline|Total|Total of all reporting groups
703301|NCT00255164|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703302|NCT00255164|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703303|NCT00255164|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703304|NCT00255164|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703305|NCT00255164|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703306|NCT00255164|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703307|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703308|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703309|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703310|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703311|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703312|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703313|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703314|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703315|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703316|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703317|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703318|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703319|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703320|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703321|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703322|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703323|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703324|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703325|NCT00255164|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703326|NCT00255164|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703327|NCT00255164|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703328|NCT00255151|B4|Baseline|Total|Total of all reporting groups
703329|NCT00255151|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703330|NCT00255151|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703331|NCT00255151|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703332|NCT00255151|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703333|NCT00255151|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703334|NCT00255151|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703335|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703336|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703337|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703338|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703339|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703340|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703341|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703342|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703343|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703344|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703345|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703346|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703347|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703348|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703349|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703350|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703351|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703352|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703353|NCT00255151|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
703354|NCT00255151|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
703355|NCT00255151|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
703356|NCT00255125|B3|Baseline|Total|Total of all reporting groups
703357|NCT00255125|B2|Baseline|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703358|NCT00255125|B1|Baseline|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703359|NCT00255125|P2|Participant Flow|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703360|NCT00255125|P1|Participant Flow|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703361|NCT00255125|O2|Outcome|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703362|NCT00255125|O1|Outcome|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703363|NCT00255125|E2|Reported Event|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703364|NCT00255125|E1|Reported Event|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
703365|NCT00255086|B3|Baseline|Total|Total of all reporting groups
703366|NCT00255086|B2|Baseline|Control|10mg Placebo pill
703367|NCT00255086|B1|Baseline|Memantine|"10mg Memantine~Memantine"
703368|NCT00255086|P2|Participant Flow|Control|Participants were given Placebo
703369|NCT00255086|P1|Participant Flow|Memantine|"10mg Memantine~Memantine"
703370|NCT00255086|O2|Outcome|Control|10mg Placebo pill
703371|NCT00255086|O1|Outcome|Memantine|"10mg Memantine~Memantine"
703372|NCT00255086|O2|Outcome|Control|Participants were given Placebo
703373|NCT00255086|O1|Outcome|Memantine|"10mg Memantine~Memantine"
703374|NCT00255086|E2|Reported Event|Control|Participants were given matching placebo
703375|NCT00255086|E1|Reported Event|Memantine|10mg Memantine
703376|NCT00255047|B5|Baseline|Total|Total of all reporting groups
703377|NCT00255047|B4|Baseline|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703378|NCT00255047|B3|Baseline|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
703379|NCT00255047|B2|Baseline|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703380|NCT00255047|B1|Baseline|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
703381|NCT00255047|P4|Participant Flow|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703382|NCT00255047|P3|Participant Flow|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
703383|NCT00255047|P2|Participant Flow|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703384|NCT00255047|P1|Participant Flow|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
703385|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703386|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
703387|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703388|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
703389|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703390|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
703391|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703392|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
703393|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703394|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
703395|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703396|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
703397|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703398|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
703399|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703400|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
703401|NCT00255047|E4|Reported Event|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703402|NCT00255047|E3|Reported Event|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
703403|NCT00255047|E2|Reported Event|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
703404|NCT00255047|E1|Reported Event|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
703405|NCT00255034|B3|Baseline|Total|Total of all reporting groups
703406|NCT00255034|B2|Baseline|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
703407|NCT00255034|B1|Baseline|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
703408|NCT00255034|P2|Participant Flow|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
703409|NCT00255034|P1|Participant Flow|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
703410|NCT00255034|O2|Outcome|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
703411|NCT00255034|O1|Outcome|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
703412|NCT00255034|E2|Reported Event|48 Weeks of Therapy|
703413|NCT00255034|E1|Reported Event|24 Weeks of Therapy|
703414|NCT00255008|B5|Baseline|Total|Total of all reporting groups
703415|NCT00255008|B4|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703416|NCT00255008|B3|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703417|NCT00255008|B2|Baseline|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703418|NCT00255008|B1|Baseline|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
703419|NCT00255008|P4|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703420|NCT00255008|P3|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703421|NCT00255008|P2|Participant Flow|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703422|NCT00255008|P1|Participant Flow|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
703423|NCT00255008|O4|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703477|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703424|NCT00255008|O3|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703425|NCT00255008|O2|Outcome|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
703426|NCT00255008|O1|Outcome|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
703427|NCT00255008|E4|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w|
703428|NCT00255008|E3|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w|
703429|NCT00255008|E2|Reported Event|Genotype 1 Caucasian PEG-IFN/RIB 48w|
703430|NCT00255008|E1|Reported Event|Genotype 1 SEA PEG-IFN/RIB 48w|
703431|NCT00254995|B3|Baseline|Total|Total of all reporting groups
703432|NCT00254995|B2|Baseline|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
703433|NCT00254995|B1|Baseline|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
703434|NCT00254995|P2|Participant Flow|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice."
703435|NCT00254995|P1|Participant Flow|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice."
703436|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
703437|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703438|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
703439|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703440|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
703441|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703442|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
703443|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703444|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
703445|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703446|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
703447|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703448|NCT00254995|O2|Outcome|Control Group|Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.
703478|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703449|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703450|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
703451|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703452|NCT00254995|O2|Outcome|Control Group|"The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.~The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals."
703453|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703454|NCT00254995|E1|Reported Event|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
703455|NCT00254982|B3|Baseline|Total|Total of all reporting groups
703456|NCT00254982|B2|Baseline|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
703457|NCT00254982|B1|Baseline|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
703458|NCT00254982|P2|Participant Flow|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
703459|NCT00254982|P1|Participant Flow|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
703460|NCT00254982|O2|Outcome|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
703461|NCT00254982|O1|Outcome|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
703462|NCT00254982|E2|Reported Event|Group 2 (Low-need)|
703463|NCT00254982|E1|Reported Event|Group 1 (High-need)|
703464|NCT00254592|B1|Baseline|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
703465|NCT00254592|P1|Participant Flow|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
703466|NCT00254592|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
703467|NCT00254592|E1|Reported Event|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
703468|NCT00254566|B3|Baseline|Total|Total of all reporting groups
703469|NCT00254566|B2|Baseline|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703470|NCT00254566|B1|Baseline|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703471|NCT00254566|P2|Participant Flow|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703472|NCT00254566|P1|Participant Flow|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703473|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703474|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703475|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703476|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
704440|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
703479|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703480|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703481|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703482|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703483|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703484|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703485|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703486|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703487|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703488|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703489|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703490|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703491|NCT00254566|E2|Reported Event|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
703492|NCT00254566|E1|Reported Event|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
703493|NCT00254540|B3|Baseline|Total|Total of all reporting groups
703494|NCT00254540|B2|Baseline|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703495|NCT00254540|B1|Baseline|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703496|NCT00254540|P2|Participant Flow|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703497|NCT00254540|P1|Participant Flow|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703498|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
703499|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
703500|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703501|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703502|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703503|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703504|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703505|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703506|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703507|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703508|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703509|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703510|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703511|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703512|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703513|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703514|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703515|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703516|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703517|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703518|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703519|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703520|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703521|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
703522|NCT00254540|E1|Reported Event|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
703523|NCT00254501|B3|Baseline|Total|Total of all reporting groups
703524|NCT00254501|B2|Baseline|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
703525|NCT00254501|B1|Baseline|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
703526|NCT00254501|P2|Participant Flow|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
703527|NCT00254501|P1|Participant Flow|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
703528|NCT00254501|O2|Outcome|EMPOWER|Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
703570|NCT00254293|O1|Outcome|All Treated Participants|ECG Heart Rate change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period
703865|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
703529|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
703530|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
703531|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
703532|NCT00254501|O2|Outcome|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
703533|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
703534|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
703535|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
703536|NCT00254501|E2|Reported Event|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
703537|NCT00254501|E1|Reported Event|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
703538|NCT00254462|B3|Baseline|Total|Total of all reporting groups
703539|NCT00254462|B2|Baseline|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
703540|NCT00254462|B1|Baseline|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
703541|NCT00254462|P2|Participant Flow|Placebo|Recommended dosing of once per day, with divided dosing allowed at investigators discretion.
703542|NCT00254462|P1|Participant Flow|Atomoxetine|Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day.
703543|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, divided dose at investigator discretion.
703544|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, divided dose at investigator discretion. Maximum daily dose of 1.8 mg/kg/day.
703545|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
703546|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.
703547|NCT00254462|E2|Reported Event|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
703548|NCT00254462|E1|Reported Event|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
703549|NCT00254293|B7|Baseline|Total|Total of all reporting groups
703550|NCT00254293|B6|Baseline|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants were rolled over to a variable dose of abatacept SC administered weekly following an IV loading dose of abatacept on Day 85.
703551|NCT00254293|B5|Baseline|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703552|NCT00254293|B4|Baseline|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
703553|NCT00254293|B3|Baseline|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
703554|NCT00254293|B2|Baseline|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703597|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703555|NCT00254293|B1|Baseline|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703556|NCT00254293|P7|Participant Flow|Fixed Dose 125 mg Abatacept|Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
703557|NCT00254293|P6|Participant Flow|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703558|NCT00254293|P5|Participant Flow|Group 5: 1000 mg IV/200 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight > 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703559|NCT00254293|P4|Participant Flow|Group 4: 1000mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight > 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight <60 to >100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703560|NCT00254293|P3|Participant Flow|Group 3 : 750 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703561|NCT00254293|P2|Participant Flow|Group 2: 500 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight < 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703562|NCT00254293|P1|Participant Flow|Group 1: 500 mg IV/75 mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight < 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703563|NCT00254293|O6|Outcome|LTE (Variable and Fixed Dosing Abatacept)|Long term extension (LTE) consisted of 2 periods: variable dosing of abatacept combined with DMARDS and fixed dosing abatacept combined with DMARDS. Participants were weighed prior to starting LTE (variable dosing) and dosing was assigned per body weight category. Variable dosing period required an IV loading dose prior to starting SC dosing (if participant had been randomized to placebo in the short term period). Variable dosing: 500 mg IV/75 mg SC and 500 mg IV/125 mg SC in participants less than (<)60 kg body weight; 750 mg IV/125 mg SC in participants between 60 and 100 kg body weight; 1000 mg IV/125 mg SC and 1000 mg IV/200 mg SC in participants greater than (>) 100 kg body weight. Participants were rolled over into a fixed SC dose of 125 mg per week in the fixed dosing period prior to their Year 2 anniversary visit for the study (as early as Day 533).
703564|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
703565|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
703566|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
703567|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
703568|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks)
703569|NCT00254293|O1|Outcome|SC Abatacept|Overall summary of all participants in the LTE. LTE Period consisted of a variable dose (75 mg, 125 mg, 200 mg abatacept) phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight.
703571|NCT00254293|O3|Outcome|200 mg SC Abatacept|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight >100kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703572|NCT00254293|O2|Outcome|125 mg SC Abatacept|125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703573|NCT00254293|O1|Outcome|75 mg SC Abatacept|variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight <60kg. At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703574|NCT00254293|O1|Outcome|All Treated Participants|ECG change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period.
703575|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
703576|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703577|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703578|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703579|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703580|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703581|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
703582|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703583|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703584|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703585|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703586|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703587|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
703588|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703589|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703590|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703591|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703592|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703593|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
703594|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703595|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703596|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703598|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703599|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
703600|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
703601|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
703602|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
703603|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
703604|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks).
703605|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
703606|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 200 mg SC (once weekly for 12 weeks).
703607|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
703608|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an IV loading dose of abatacept on Day 1 of 750 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
703609|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
703610|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 75 mg SC (once weekly for 12 weeks).
703611|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
703612|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703613|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703614|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703615|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703616|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703617|NCT00254293|O3|Outcome|200 mg SC Abatacept (Body Weight > 100 kg)|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (1000 mg IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703618|NCT00254293|O2|Outcome|125 mg SC Abatacept (Body Weight <60 to >100 kg)|Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703619|NCT00254293|O1|Outcome|75 mg SC Abatacept (Body Weight < 60 kg)|Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly), or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
703620|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703681|NCT00253981|O2|Outcome|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
703682|NCT00253981|O1|Outcome|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
703621|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
703622|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
703623|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703624|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703625|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703626|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
703627|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
703628|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703629|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
703630|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703631|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703632|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703633|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703634|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
703635|NCT00254293|E7|Reported Event|Placebo (ST)|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703636|NCT00254293|E6|Reported Event|Abatacept (LT) 125 mg SC|Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
703683|NCT00253981|E2|Reported Event|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
703684|NCT00253981|E1|Reported Event|Experimental|The experimental group received the monochromatic light infrared red energy treatment (MIRE).
703685|NCT00253890|B3|Baseline|Total|Total of all reporting groups
703686|NCT00253890|B2|Baseline|Placebo|1-3 at bedtime
703637|NCT00254293|E5|Reported Event|Abatacept 750mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703638|NCT00254293|E4|Reported Event|Abatacept 500mg IV/75mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703639|NCT00254293|E3|Reported Event|Abatacept 500mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703640|NCT00254293|E2|Reported Event|Abatacept 1000mg IV/200mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703641|NCT00254293|E1|Reported Event|Abatacept 1000mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
703642|NCT00254163|B3|Baseline|Total|Total of all reporting groups
703643|NCT00254163|B2|Baseline|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703644|NCT00254163|B1|Baseline|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703645|NCT00254163|P2|Participant Flow|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703646|NCT00254163|P1|Participant Flow|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703647|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703648|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703649|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703650|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703651|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703652|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703653|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703654|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703655|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703656|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703657|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703658|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703659|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703660|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703661|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703662|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703663|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703664|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703665|NCT00254163|E2|Reported Event|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
703666|NCT00254163|E1|Reported Event|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
703667|NCT00254072|B3|Baseline|Total|Total of all reporting groups
703668|NCT00254072|B2|Baseline|Larger Stapler|4.8 mm Circular Stapler
703669|NCT00254072|B1|Baseline|Smaller Stapler|3.5 mm Circular Stapler
703670|NCT00254072|P2|Participant Flow|Larger Stapler|4.8 mm Circular Stapler
703671|NCT00254072|P1|Participant Flow|Smaller Stapler|3.5 mm Circular Stapler
703672|NCT00254072|O2|Outcome|Larger Stapler|4.8 mm Circular Stapler
703673|NCT00254072|O1|Outcome|Smaller Stapler|3.5 mm Circular Stapler
703674|NCT00254072|E2|Reported Event|Larger Stapler|4.8 mm Circular Stapler
703675|NCT00254072|E1|Reported Event|Smaller Stapler|3.5 mm Circular Stapler
703676|NCT00253981|B3|Baseline|Total|Total of all reporting groups
703677|NCT00253981|B2|Baseline|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
703678|NCT00253981|B1|Baseline|Experimental|The experimental group received the monochromatic light infrared energy treatment (MIRE).
703679|NCT00253981|P2|Participant Flow|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
703680|NCT00253981|P1|Participant Flow|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
703695|NCT00253747|B2|Baseline|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
703696|NCT00253747|B1|Baseline|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
703697|NCT00253747|P2|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703698|NCT00253747|P1|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703699|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703700|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703701|NCT00253747|O10|Outcome|Methylphenidate (OROS-MPH) - Placebo-Week 9|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703702|NCT00253747|O9|Outcome|Release Methylphenidate (OROS-MPH)-Week 9|OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703703|NCT00253747|O8|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703704|NCT00253747|O7|Outcome|Release Methylphenidate (OROS-MPH)-Week 7|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703705|NCT00253747|O6|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703706|NCT00253747|O5|Outcome|Release Methylphenidate (OROS-MPH)-Week 4|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703707|NCT00253747|O4|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703708|NCT00253747|O3|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Week 11|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703709|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Baseline|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703710|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Baseline|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703711|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703712|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
703713|NCT00253747|E2|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
703784|NCT00253448|P1|Participant Flow|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
703714|NCT00253747|E1|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
703715|NCT00253708|B4|Baseline|Total|Total of all reporting groups
703716|NCT00253708|B3|Baseline|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703717|NCT00253708|B2|Baseline|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703718|NCT00253708|B1|Baseline|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703719|NCT00253708|P3|Participant Flow|Usual Care (Control)|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703720|NCT00253708|P2|Participant Flow|No Touch Intervention (Control)|The authors wanted to separate out the effect of interacting with a massage therapist from massage itself, so the therapists performed no-touch control interventions, which had no healing intention. Although most of the therapists had experience with energy healing, the therapists were trained to avoid ‘‘healing intention’’ in the no-touch group by using distraction if necessary, created by counting backwards. For the no-touch control intervention, therapists were instructed to be with the patients between 15 and 45 minutes, depending on the patient’s tolerance, and to hold their hands about 12 inches over the patient’s body. In the usual-care control group, patients completed the same questionnaires but did not receive any visits from the massage therapists.
703721|NCT00253708|P1|Participant Flow|Touch Intervention (Massage Therapy)|Patients received three visits by the professional massage therapists over the first week after the enrollment. Massage treatments were scheduled based on patient preferences, and the duration was between 15 and 45 minutes; both the duration and the amount of pressure was modified depending on patient comfort. A limited scope of practice was provided to the massage therapists that specified the allowed and disallowed massage modalities and techniques. Allowed techniques were both Swedish and non-Swedish massage including gliding/effleurage, gentle kneading/petrissage, compression, gentle stretching, rocking, light myofascial release, active and/or passive range of motion, warm or cool applications, and use of acupressure points as well as craniosacral holds thought to have calming and centering effects. No forms of friction, deep-tissue massage, or bodywork forms that required movement by the patients were allowed.
703722|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703723|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703724|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703725|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703726|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703727|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703728|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703729|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703730|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703731|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703822|NCT00252967|B2|Baseline|Atorvastatin|
703823|NCT00252967|B1|Baseline|Placebo|
703824|NCT00252967|P2|Participant Flow|Atorvastatin|
703825|NCT00252967|P1|Participant Flow|Placebo|
703732|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703733|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703734|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703735|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703736|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703737|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703738|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703739|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703740|NCT00253708|O3|Outcome|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703741|NCT00253708|O2|Outcome|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703742|NCT00253708|O1|Outcome|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703743|NCT00253708|E3|Reported Event|Usual Care|Patients did not receive visits from massage therapists. Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment
703744|NCT00253708|E2|Reported Event|No-touch Control|"Patients received 3 no-touch therapy visits from massage therapists who provided no-touch without healing intention.Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703745|NCT00253708|E1|Reported Event|Massage|"Patients received 3 massage therapy visits from massage therapists in initial week with a duration of 15-45 minutes.NOTE: Intervention 'management of therapy complications' has not been included in any Arm/Group Descriptions.~Patients were intended to receive pain therapy, psychosocial assessment and care, and quality-of-life assessment~management of therapy complications~massage therapy~pain therapy~psychosocial assessment and care~quality-of-life assessment"
703746|NCT00253643|B5|Baseline|Total|Total of all reporting groups
703747|NCT00253643|B4|Baseline|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
703748|NCT00253643|B3|Baseline|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
703749|NCT00253643|B2|Baseline|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
703750|NCT00253643|B1|Baseline|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
703751|NCT00253643|P4|Participant Flow|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
703752|NCT00253643|P3|Participant Flow|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
703826|NCT00252967|O2|Outcome|Atorvastatin|
703827|NCT00252967|O1|Outcome|Placebo|
703828|NCT00252967|O2|Outcome|Atorvastatin|
703753|NCT00253643|P2|Participant Flow|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
703754|NCT00253643|P1|Participant Flow|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
703755|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
703756|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
703757|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
703758|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
703759|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
703760|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
703761|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
703762|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
703763|NCT00253643|E4|Reported Event|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
703764|NCT00253643|E3|Reported Event|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
703765|NCT00253643|E2|Reported Event|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
703766|NCT00253643|E1|Reported Event|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
703767|NCT00253630|B1|Baseline|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703768|NCT00253630|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703769|NCT00253630|O1|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703770|NCT00253630|O1|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703771|NCT00253630|O1|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703772|NCT00253630|O1|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703773|NCT00253630|O1|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703774|NCT00253630|O1|Outcome|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703775|NCT00253630|E1|Reported Event|Treatment (Vorinostat)|"Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Vorinostat: Given PO"
703776|NCT00253513|B1|Baseline|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
703777|NCT00253513|P1|Participant Flow|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
703778|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
703779|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
703780|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
703781|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
703782|NCT00253513|E1|Reported Event|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
703783|NCT00253448|B1|Baseline|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
703785|NCT00253448|O1|Outcome|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
703786|NCT00253448|E1|Reported Event|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
703787|NCT00253435|B3|Baseline|Total|Total of all reporting groups
703788|NCT00253435|B2|Baseline|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
703789|NCT00253435|B1|Baseline|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
703790|NCT00253435|P2|Participant Flow|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
703791|NCT00253435|P1|Participant Flow|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
703792|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
703793|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
703794|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
703795|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
703796|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
703797|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
703798|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
703799|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
703800|NCT00253435|E2|Reported Event|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
703801|NCT00253435|E1|Reported Event|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
703802|NCT00253370|B1|Baseline|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
703803|NCT00253370|P1|Participant Flow|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
703804|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
703805|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
703806|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
703807|NCT00253370|E1|Reported Event|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
703808|NCT00253019|B4|Baseline|Total|Total of all reporting groups
703809|NCT00253019|B3|Baseline|Ortho Evra|Participants self-selected to receive Ortho Evra.
703810|NCT00253019|B2|Baseline|Depo Provera|Participants self-selected to receive Depo Provera
703811|NCT00253019|B1|Baseline|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
703812|NCT00253019|P3|Participant Flow|Ortho Evra|Participants self-selected to receive Ortho Evra.
703813|NCT00253019|P2|Participant Flow|Depo Provera|Participants self-selected to receive Depo Provera
703814|NCT00253019|P1|Participant Flow|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
703815|NCT00253019|O3|Outcome|Ortho Evra|Participants self-selected to receive Ortho Evra.
703816|NCT00253019|O2|Outcome|Depo Provera|Participants self-selected to receive Depo Provera
703817|NCT00253019|O1|Outcome|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
703818|NCT00253019|E3|Reported Event|Ortho Evra|participants self-selected to receive ortho evra
703819|NCT00253019|E2|Reported Event|Depo Provera|Participants self-selected to use depo provera
703820|NCT00253019|E1|Reported Event|Oral Contraceptives|participants self-selected to take oral contraceptives
703821|NCT00252967|B3|Baseline|Total|Total of all reporting groups
703867|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
703868|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
703869|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
703870|NCT00252720|E2|Reported Event|Placebo|Placebo Comparator
703871|NCT00252720|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
703872|NCT00252694|B3|Baseline|Total|Total of all reporting groups
703873|NCT00252694|B2|Baseline|Placebo|Placebo Comparator
703874|NCT00252694|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
703875|NCT00252694|P2|Participant Flow|Placebo|Placebo Comparator
703876|NCT00252694|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
703877|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
703878|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
703879|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
703880|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
703881|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
703882|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
703883|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
703884|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
703885|NCT00252694|E2|Reported Event|Placebo|Placebo Comparator
703886|NCT00252694|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
703887|NCT00252629|B4|Baseline|Total|Total of all reporting groups
703888|NCT00252629|B3|Baseline|Healthy Asymptomatic Control|"Eleven male veterans of first gulf war were screened for fatigue, pain and cognitive dysfunction by self report instrument.~They all score below the clinical thershold and assigned as healthy asymptomatic"
703889|NCT00252629|B2|Baseline|Sham Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
703890|NCT00252629|B1|Baseline|Therapeutic Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
703891|NCT00252629|P3|Participant Flow|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 18 male veterans with GWS (same group that were randomized to receive CPAP treatment) and 11 asymptomatic male veterans of the first Gulf war.~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
703892|NCT00252629|P2|Participant Flow|Sham Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with sham nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on sham nasal CPAP."
703893|NCT00252629|P1|Participant Flow|Therapeutic Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with therapeutic nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on therapeutic nasal CPAP."
703894|NCT00252629|O2|Outcome|Asymptomatic Male Veterans of Gulf War.|"A group of 11 asymptomatic male veterans of gulf war were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
703895|NCT00252629|O1|Outcome|GWS Male Group|"A group of18 male veterans with GWS were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
703896|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment on sham nasal CPAP
703897|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment of therapeutic nasal CPAP
703898|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of pain complaint before and after treatment of 3 weeks on sham nasal CPAP
703899|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of pain complaint before and after 3 weeks treatment of therapeutic nasal CPAP
703900|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
703901|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP
703932|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
703902|NCT00252629|E3|Reported Event|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 11 asymptomatic male veterans of the first Gulf war. In addition to our 18 male veterans with GWS (same group that were randomized to receive CPAP treatment).~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
703903|NCT00252629|E2|Reported Event|Sham Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on sham nasal CPAP with change of symptoms on therapeutic nasal CPAP
703904|NCT00252629|E1|Reported Event|Therapeutic Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on therapeutic nasal CPAP with change of symptoms on sham nasal CPAP
703905|NCT00252590|B4|Baseline|Total|Total of all reporting groups
703906|NCT00252590|B3|Baseline|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
703907|NCT00252590|B2|Baseline|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
703908|NCT00252590|B1|Baseline|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
703909|NCT00252590|P3|Participant Flow|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
703910|NCT00252590|P2|Participant Flow|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use provided in four once monthly 45-minute sessions. Topics for sessions include sleep, pain, cardiovascular health, and gastrointestinal health."
703911|NCT00252590|P1|Participant Flow|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status provided in four once monthly 45 minute sessions. Information for feedback was attained with assessments and blood serum testing."
703912|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
703913|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
703914|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
703915|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
703916|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
703917|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
703918|NCT00252590|E3|Reported Event|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
703919|NCT00252590|E2|Reported Event|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
703920|NCT00252590|E1|Reported Event|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
703921|NCT00252564|B3|Baseline|Total|Total of all reporting groups
703922|NCT00252564|B2|Baseline|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
703923|NCT00252564|B1|Baseline|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
703924|NCT00252564|P2|Participant Flow|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
703925|NCT00252564|P1|Participant Flow|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
703926|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
703927|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
703928|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
703929|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
703930|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
703931|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
703933|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
703934|NCT00252564|E2|Reported Event|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
703935|NCT00252564|E1|Reported Event|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
703936|NCT00252538|B1|Baseline|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
703937|NCT00252538|P2|Participant Flow|Group 2 Non MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
703938|NCT00252538|P1|Participant Flow|Group 1 MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
703939|NCT00252538|O2|Outcome|Group 2- no MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
703940|NCT00252538|O1|Outcome|Group 1- MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
703941|NCT00252538|E1|Reported Event|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
703942|NCT00252512|B3|Baseline|Total|Total of all reporting groups
703943|NCT00252512|B2|Baseline|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
703944|NCT00252512|B1|Baseline|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
703945|NCT00252512|P2|Participant Flow|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
703946|NCT00252512|P1|Participant Flow|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
703947|NCT00252512|O2|Outcome|Arm 2|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
703995|NCT00252239|O2|Outcome|TNK 0.25 mg/kg|Medium dose tenecteplase
703996|NCT00252239|O1|Outcome|TNK 0.1 mg/kg|Lowest dose tenecteplase
703997|NCT00252239|E4|Reported Event|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
703998|NCT00252239|E3|Reported Event|TNK 0.4 mg/kg|Highest dose tenecteplase
703948|NCT00252512|O1|Outcome|Arm 1|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
703949|NCT00252512|E2|Reported Event|Baseline|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
703950|NCT00252512|E1|Reported Event|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
703951|NCT00252499|B4|Baseline|Total|Total of all reporting groups
703952|NCT00252499|B3|Baseline|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703953|NCT00252499|B2|Baseline|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703954|NCT00252499|B1|Baseline|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703955|NCT00252499|P3|Participant Flow|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703956|NCT00252499|P2|Participant Flow|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703957|NCT00252499|P1|Participant Flow|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703958|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703959|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703960|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703961|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703962|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703963|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703964|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703965|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703966|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703967|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703968|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703969|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703970|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703971|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703972|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703973|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703974|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703975|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703976|NCT00252499|E3|Reported Event|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
703977|NCT00252499|E2|Reported Event|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
703978|NCT00252499|E1|Reported Event|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
703979|NCT00252382|B1|Baseline|Total|Open label administration of SNS-595 48 mg/m2 treatment on day one of 21 day cycles, up to 6 cycles.
703980|NCT00252382|P1|Participant Flow|Treatment With 48 mg/m2 of SNS-595|"Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)~SNS-595 Injection: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis."
703981|NCT00252382|O1|Outcome|Total|SNS-595 48 mg/m2
703982|NCT00252382|O1|Outcome|Total|SNS-595 48 mg/m2
703983|NCT00252382|E1|Reported Event|Total|SNS-595 48 mg/m2
703984|NCT00252239|B5|Baseline|Total|Total of all reporting groups
703985|NCT00252239|B4|Baseline|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
703986|NCT00252239|B3|Baseline|TNK 0.4 mg/kg|Highest dose tenecteplase
703987|NCT00252239|B2|Baseline|TNK 0.25 mg/kg|Medium dose tenecteplase
703988|NCT00252239|B1|Baseline|TNK 0.1 mg/kg|Lowest dose tenecteplase
703989|NCT00252239|P4|Participant Flow|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
703990|NCT00252239|P3|Participant Flow|TNK 0.4 mg/kg|Highest dose tenecteplase
703991|NCT00252239|P2|Participant Flow|TNK 0.25 mg/kg|Medium dose tenecteplase
703992|NCT00252239|P1|Participant Flow|TNK 0.1 mg/kg|Lowest dose tenecteplase
703993|NCT00252239|O4|Outcome|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
703994|NCT00252239|O3|Outcome|TNK 0.4 mg/kg|Highest dose tenecteplase
703999|NCT00252239|E2|Reported Event|TNK 0.25 mg/kg|Medium dose tenecteplase
704000|NCT00252239|E1|Reported Event|TNK 0.1 mg/kg|Lowest dose tenecteplase
704001|NCT00252187|B3|Baseline|Total|Total of all reporting groups
704002|NCT00252187|B2|Baseline|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704003|NCT00252187|B1|Baseline|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704004|NCT00252187|P2|Participant Flow|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704005|NCT00252187|P1|Participant Flow|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704006|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704007|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704008|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704009|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704010|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704011|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704012|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704013|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704014|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704015|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704016|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704017|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704018|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704019|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704020|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
704021|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704022|NCT00252187|E2|Reported Event|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks
704023|NCT00252187|E1|Reported Event|BPN Group|BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
704024|NCT00252174|B4|Baseline|Total|Total of all reporting groups
704025|NCT00252174|B3|Baseline|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704026|NCT00252174|B2|Baseline|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704027|NCT00252174|B1|Baseline|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704028|NCT00252174|P3|Participant Flow|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704029|NCT00252174|P2|Participant Flow|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704030|NCT00252174|P1|Participant Flow|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704044|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704441|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704031|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704032|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704033|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704034|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704035|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704036|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704037|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704038|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704039|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704040|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704041|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704042|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704043|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704081|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704082|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704045|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704046|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704047|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704048|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704049|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704050|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704051|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704052|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704053|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704054|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704055|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704056|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704057|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704083|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704084|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704442|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704058|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704059|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704060|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704061|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704062|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704063|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704064|NCT00252174|E3|Reported Event|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704065|NCT00252174|E2|Reported Event|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
704066|NCT00252174|E1|Reported Event|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
704067|NCT00252057|B3|Baseline|Total|Total of all reporting groups
704068|NCT00252057|B2|Baseline|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
704069|NCT00252057|B1|Baseline|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
704070|NCT00252057|P2|Participant Flow|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
704071|NCT00252057|P1|Participant Flow|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
704072|NCT00252057|O2|Outcome|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
704073|NCT00252057|O1|Outcome|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
704074|NCT00252057|E2|Reported Event|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
704075|NCT00252057|E1|Reported Event|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
704076|NCT00251979|B3|Baseline|Total|Total of all reporting groups
704077|NCT00251979|B2|Baseline|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704078|NCT00251979|B1|Baseline|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704079|NCT00251979|P2|Participant Flow|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704080|NCT00251979|P1|Participant Flow|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704085|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704086|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704087|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704088|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704089|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704090|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704091|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704092|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704093|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704094|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704095|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704096|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704097|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704098|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704099|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704100|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704101|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704102|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704103|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704104|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704105|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704106|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704107|NCT00251979|E2|Reported Event|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704108|NCT00251979|E1|Reported Event|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
704109|NCT00251927|B3|Baseline|Total|Total of all reporting groups
704110|NCT00251927|B2|Baseline|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704111|NCT00251927|B1|Baseline|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704112|NCT00251927|P2|Participant Flow|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704113|NCT00251927|P1|Participant Flow|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704114|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704115|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704116|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704117|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704118|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704119|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704120|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704121|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704122|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704123|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704124|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704125|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704126|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704127|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704128|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704129|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704130|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704131|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704132|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704133|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704134|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704135|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704136|NCT00251927|E3|Reported Event|Non-Surgical Arm|This group of patients was randomized to receive surgery but were on operated on and were followed for safety purposes
704137|NCT00251927|E2|Reported Event|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
704138|NCT00251927|E1|Reported Event|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
704139|NCT00251862|B4|Baseline|Total|Total of all reporting groups
704140|NCT00251862|B3|Baseline|Control|Standard Care
704141|NCT00251862|B2|Baseline|DA Alone|Decision aid alone
704142|NCT00251862|B1|Baseline|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
704143|NCT00251862|P3|Participant Flow|Control|Standard Care
704144|NCT00251862|P2|Participant Flow|DA Alone|Decision aid alone
704145|NCT00251862|P1|Participant Flow|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
704146|NCT00251862|O3|Outcome|Control|Standard Care
704147|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
704148|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
704149|NCT00251862|O3|Outcome|Control|Standard Care
704150|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
704151|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
704152|NCT00251862|O3|Outcome|Control|Standard Care
704153|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
704154|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
704155|NCT00251862|O3|Outcome|Control|Standard Care
704156|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
704157|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
704158|NCT00251862|E3|Reported Event|Control|Standard Care
704159|NCT00251862|E2|Reported Event|DA Alone|Decision aid alone
704160|NCT00251862|E1|Reported Event|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
704161|NCT00251758|B4|Baseline|Total|Total of all reporting groups
704162|NCT00251758|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704163|NCT00251758|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704164|NCT00251758|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704165|NCT00251758|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704166|NCT00251758|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704167|NCT00251758|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704168|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704169|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704170|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704171|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704172|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704173|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704174|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704175|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704176|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704177|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704178|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704179|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704180|NCT00251758|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704181|NCT00251758|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704182|NCT00251758|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704183|NCT00251745|B4|Baseline|Total|Total of all reporting groups
704443|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704184|NCT00251745|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704185|NCT00251745|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704186|NCT00251745|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704187|NCT00251745|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704188|NCT00251745|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704189|NCT00251745|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704190|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704191|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704192|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704193|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704194|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704195|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704196|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704197|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704198|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704199|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704200|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704201|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704202|NCT00251745|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
704203|NCT00251745|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
704204|NCT00251745|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
704205|NCT00251719|B4|Baseline|Total|Total of all reporting groups
704206|NCT00251719|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704207|NCT00251719|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704208|NCT00251719|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704209|NCT00251719|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704210|NCT00251719|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704211|NCT00251719|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704212|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704213|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704214|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704215|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704216|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704217|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704218|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704219|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704220|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704221|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704222|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704223|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704224|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704225|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704226|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704227|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704228|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704229|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704230|NCT00251719|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704231|NCT00251719|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704232|NCT00251719|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704233|NCT00251693|B4|Baseline|Total|Total of all reporting groups
704234|NCT00251693|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704235|NCT00251693|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704444|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704236|NCT00251693|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704237|NCT00251693|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704238|NCT00251693|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704239|NCT00251693|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704240|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704241|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704242|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704243|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704244|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704245|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704246|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704247|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704248|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704249|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704250|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704251|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704252|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704253|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704254|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704255|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704256|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704257|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704258|NCT00251693|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
704259|NCT00251693|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
704260|NCT00251693|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
704261|NCT00251641|B3|Baseline|Total|Total of all reporting groups
704262|NCT00251641|B2|Baseline|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
704263|NCT00251641|B1|Baseline|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
704264|NCT00251641|P2|Participant Flow|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
704265|NCT00251641|P1|Participant Flow|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
704266|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
704267|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
704268|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
704269|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
704445|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704446|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704447|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704448|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704270|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
704271|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
704272|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
704273|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
704274|NCT00251641|E4|Reported Event|Participants Who Switched From Methotrexate to Infliximab|Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
704275|NCT00251641|E3|Reported Event|Participants Who Switched From Infliximab to Methotrexate|Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
704276|NCT00251641|E2|Reported Event|Methotrexate|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
704277|NCT00251641|E1|Reported Event|Infliximab|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
704278|NCT00251589|B5|Baseline|Total|Total of all reporting groups
704279|NCT00251589|B4|Baseline|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704280|NCT00251589|B3|Baseline|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704281|NCT00251589|B2|Baseline|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704282|NCT00251589|B1|Baseline|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704283|NCT00251589|P4|Participant Flow|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704284|NCT00251589|P3|Participant Flow|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704285|NCT00251589|P2|Participant Flow|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704286|NCT00251589|P1|Participant Flow|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704287|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704288|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704289|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704449|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704450|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704451|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704452|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704290|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704291|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704292|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704293|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704294|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704295|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704296|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704297|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704298|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704299|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704300|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704301|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704302|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704303|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704304|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704305|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704306|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704307|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704308|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704309|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704310|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704311|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704312|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704313|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704314|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704315|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704316|NCT00251589|E4|Reported Event|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
704317|NCT00251589|E3|Reported Event|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704318|NCT00251589|E2|Reported Event|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
704319|NCT00251589|E1|Reported Event|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
704320|NCT00251316|B3|Baseline|Total|Total of all reporting groups
704321|NCT00251316|B2|Baseline|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
704322|NCT00251316|B1|Baseline|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
704323|NCT00251316|P2|Participant Flow|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
704324|NCT00251316|P1|Participant Flow|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
704325|NCT00251316|O2|Outcome|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
704326|NCT00251316|O1|Outcome|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
704327|NCT00251316|E2|Reported Event|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
704328|NCT00251316|E1|Reported Event|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
704329|NCT00251303|B3|Baseline|Total|Total of all reporting groups
704330|NCT00251303|B2|Baseline|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
704331|NCT00251303|B1|Baseline|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
704332|NCT00251303|P2|Participant Flow|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
704333|NCT00251303|P1|Participant Flow|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
704334|NCT00251303|O2|Outcome|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
704335|NCT00251303|O1|Outcome|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
704336|NCT00251303|O2|Outcome|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
704337|NCT00251303|O1|Outcome|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
704338|NCT00251303|E2|Reported Event|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
704339|NCT00251303|E1|Reported Event|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
704340|NCT00251238|B3|Baseline|Total|Total of all reporting groups
704341|NCT00251238|B2|Baseline|Control Group|Receiving matching placebo
704342|NCT00251238|B1|Baseline|Intervention Group|active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks
704343|NCT00251238|P2|Participant Flow|Placebo Group|receiving matching placebo
704344|NCT00251238|P1|Participant Flow|Intervention Group|active treatment group, receiving oral film-coated tablet of 120-mg Ginkgo Biloba special extract (EGb 761) 2 times a day for 10 weeks, after an initial 2-week run-in phase
704345|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
704346|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
704347|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
704348|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
704349|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
704350|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
704351|NCT00251238|E2|Reported Event|Placebo Group|receiving placebo
704352|NCT00251238|E1|Reported Event|Intervention Group|active treatment group (EGb 761)
704353|NCT00251225|B1|Baseline|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
704354|NCT00251225|P1|Participant Flow|Hormone Refractory Prostate Cancer Patients|Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
704355|NCT00251225|O1|Outcome|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
704356|NCT00251225|O1|Outcome|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
704357|NCT00251225|O1|Outcome|Hormone Refractory Prostate Cancer Patients|Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
704358|NCT00251225|E1|Reported Event|Hormone Refractory Prostate Cancer Patients|Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days
704359|NCT00251004|B4|Baseline|Total|Total of all reporting groups
704360|NCT00251004|B3|Baseline|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704361|NCT00251004|B2|Baseline|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704362|NCT00251004|B1|Baseline|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704363|NCT00251004|P3|Participant Flow|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704364|NCT00251004|P2|Participant Flow|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704365|NCT00251004|P1|Participant Flow|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704366|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704367|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704368|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704369|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704370|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704371|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704372|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704373|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704374|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704375|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704376|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704377|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704378|NCT00251004|E3|Reported Event|Control Group|"1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704379|NCT00251004|E2|Reported Event|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704380|NCT00251004|E1|Reported Event|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
704381|NCT00250926|B1|Baseline|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
704382|NCT00250926|P1|Participant Flow|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
704383|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.~Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
704397|NCT00250718|B1|Baseline|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
704384|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.~Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
704385|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
704386|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
704387|NCT00250926|E1|Reported Event|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
704388|NCT00250835|B1|Baseline|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704389|NCT00250835|P1|Participant Flow|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704390|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704391|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704392|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704393|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704394|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704395|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704396|NCT00250835|E1|Reported Event|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
704422|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704423|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704424|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704398|NCT00250718|P1|Participant Flow|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
704399|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
704400|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
704401|NCT00250718|E1|Reported Event|Arm 1 Combination Treatment|"VP-16 50mg/d PO x14 days q 28 days + Chlorambucil 0.1mg/kg/d PO x14 days q 28 days + Vincristine 2mg IV x14 days + Dexamethasone 200mg IV q 24 days + Rituxan (rituximab) 375 mg/m2 IVI x14 days + Levofloxacin 500 mg PO qd + Diflucan 200 mg PO qd~Vincristine: should be administered intravenously through a freely-running IV at 2mg q 14 days.~VP-16: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x14 days q 28 days.~Rituximab: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.~Dexamethasone: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.~Levofloxacin: Levofloxacin will be administ"
704402|NCT00250705|B1|Baseline|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
704403|NCT00250705|P1|Participant Flow|Aripiprazole Treatment of Conduct Disorde|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.
704404|NCT00250705|O1|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
704405|NCT00250705|O1|Outcome|Adolescent Conduct Disorder Males|"All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.~Aripiprazole: The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. The dose was individualized based on response and tolerance with a maximum of 20 mg per day."
704406|NCT00250705|O1|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
704407|NCT00250705|O1|Outcome|Adolescent Conduct Disorder Males|"All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole.~Aripiprazole: The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. The dose was individualized based on response and tolerance with a maximum of 20 mg per day."
704408|NCT00250705|O1|Outcome|Aripiprazole Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 10 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000). The initial aripiprazole dose depending on the weight of the patient was: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose was individualized based on the response and tolerance to the drug with a maximum aripiprazole dose of 20 mg/d. Current psychotropic medications were not washed out of the patients at the beginning of the study due to the exploratory stage of use of the drug for the conduct disorder indication.
704409|NCT00250705|E1|Reported Event|Aripiprazole in the Treatment of Conduct Disorder|The study was a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder (American Psychiatric Association 2000).
704410|NCT00250679|B4|Baseline|Total|Total of all reporting groups
704411|NCT00250679|B3|Baseline|Arformoterol 25 Mcg 2x/Day|
704412|NCT00250679|B2|Baseline|Arformoterol 15 Mcg 2x/Day|
704413|NCT00250679|B1|Baseline|Formoterol 12 Mcg 2x/Day|
704414|NCT00250679|P3|Participant Flow|Arformoterol 25 Mcg 2x/Day|
704415|NCT00250679|P2|Participant Flow|Arformoterol 15 Mcg 2x/Day|
704416|NCT00250679|P1|Participant Flow|Formoterol 12 Mcg 2x/Day|
704417|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704418|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704419|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704420|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704421|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704453|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704454|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704455|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704456|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704457|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704458|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704459|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704460|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704461|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704462|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704463|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704464|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704465|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704466|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704467|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704468|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704469|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704470|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704471|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704472|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704473|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704474|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704475|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704476|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704477|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704478|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704479|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704480|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704481|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704482|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704483|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704484|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704485|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704486|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704487|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704488|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704489|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704490|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704491|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704492|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704493|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704494|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704495|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704496|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704497|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704498|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704499|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704500|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704501|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704502|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704503|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704504|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704505|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704506|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704507|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
704508|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
704509|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
704510|NCT00250679|E3|Reported Event|Arformoterol 25 Mcg 2x/Day|
704511|NCT00250679|E2|Reported Event|Arformoterol 15 Mcg 2x/Day|
704512|NCT00250679|E1|Reported Event|Formoterol 12 Mcg 2x/Day|
704513|NCT00250588|B4|Baseline|Total|Total of all reporting groups
704514|NCT00250588|B3|Baseline|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
704515|NCT00250588|B2|Baseline|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework – identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework – defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework – implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
704516|NCT00250588|B1|Baseline|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor’s level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
704517|NCT00250588|P3|Participant Flow|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
704557|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704518|NCT00250588|P2|Participant Flow|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
704519|NCT00250588|P1|Participant Flow|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
704520|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
704521|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
704522|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
704523|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
704524|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
704525|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
704526|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
704558|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704559|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704560|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
705959|NCT00245518|O1|Outcome|Placebo|Placebo
704527|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
704528|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
704529|NCT00250588|E3|Reported Event|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
704530|NCT00250588|E2|Reported Event|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
704531|NCT00250588|E1|Reported Event|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
704532|NCT00250497|B3|Baseline|Total|Total of all reporting groups
704533|NCT00250497|B2|Baseline|Control Group|All Girls PE Control Group
704534|NCT00250497|B1|Baseline|Intervention Group|New Moves Intervention
704535|NCT00250497|P2|Participant Flow|Control Group|All Girls PE Control group
704536|NCT00250497|P1|Participant Flow|Intervention Group|New Moves Intervention
704537|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
704538|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
704539|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
704540|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
704541|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
704542|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
704543|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
704544|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
704545|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
704546|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
704547|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
704548|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
704549|NCT00250497|E2|Reported Event|Control Group|All Girls PE Control Group
704550|NCT00250497|E1|Reported Event|Intervention Group|New Moves Intervention Group
704551|NCT00250484|B3|Baseline|Total|Total of all reporting groups
704552|NCT00250484|B2|Baseline|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704553|NCT00250484|B1|Baseline|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704554|NCT00250484|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704555|NCT00250484|P1|Participant Flow|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704556|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704873|NCT00249288|O2|Outcome|Not Deficit Syndrome|Participants without deficit syndrome
704561|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704562|NCT00250484|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704563|NCT00250484|E1|Reported Event|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
704564|NCT00250458|B3|Baseline|Total|Total of all reporting groups
704565|NCT00250458|B2|Baseline|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
704566|NCT00250458|B1|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
704567|NCT00250458|P2|Participant Flow|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
704568|NCT00250458|P1|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
704569|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
704570|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
704571|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
704572|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
704573|NCT00250458|E2|Reported Event|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
704574|NCT00250458|E1|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
704575|NCT00250432|B3|Baseline|Total|Total of all reporting groups
704576|NCT00250432|B2|Baseline|Caspofungin 150 mg|Caspofungin 150 mg IV daily
704577|NCT00250432|B1|Baseline|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
704578|NCT00250432|P2|Participant Flow|Caspofungin 150 mg|Caspofungin 150 mg IV daily
704579|NCT00250432|P1|Participant Flow|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
704580|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
704581|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
704582|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
704583|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
704584|NCT00250432|E2|Reported Event|Caspofungin 150 mg|Caspofungin 150 mg IV daily
704585|NCT00250432|E1|Reported Event|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
704586|NCT00250276|B5|Baseline|Total|Total of all reporting groups
704587|NCT00250276|B4|Baseline|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704588|NCT00250276|B3|Baseline|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704589|NCT00250276|B2|Baseline|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704590|NCT00250276|B1|Baseline|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704591|NCT00250276|P4|Participant Flow|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704592|NCT00250276|P3|Participant Flow|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704593|NCT00250276|P2|Participant Flow|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704594|NCT00250276|P1|Participant Flow|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704874|NCT00249288|O1|Outcome|Deficit Syndrome|Study participants with deficit syndrome
704875|NCT00249288|O2|Outcome|Not Deficit Syndrome|Participants without deficit syndrome
704595|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704596|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704597|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704598|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704599|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704600|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704601|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704602|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704603|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704604|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704605|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704606|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704607|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704608|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704609|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704610|NCT00250276|O2|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704611|NCT00250276|O1|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704612|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704613|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704774|NCT00249808|O1|Outcome|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
704614|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704615|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704616|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704617|NCT00250276|O2|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704618|NCT00250276|O1|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704619|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704620|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704621|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704622|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704623|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704624|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704625|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704626|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704627|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704628|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704629|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704630|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704631|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704632|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704950|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704633|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704634|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704635|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704636|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704637|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704638|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704639|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704640|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704641|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704642|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704643|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704644|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704645|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704646|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704647|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704648|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704649|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704650|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704864|NCT00249379|E2|Reported Event|Control|No specific intervention, monitored for outcomes
704865|NCT00249379|E1|Reported Event|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
704651|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704652|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704653|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704654|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704655|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704656|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704657|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704658|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704659|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704660|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704661|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704662|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704663|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704664|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704665|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704666|NCT00250276|E5|Reported Event|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704667|NCT00250276|E4|Reported Event|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
704668|NCT00250276|E3|Reported Event|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704669|NCT00250276|E2|Reported Event|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704670|NCT00250276|E1|Reported Event|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
704671|NCT00249873|B3|Baseline|Total|Total of all reporting groups
704672|NCT00249873|B2|Baseline|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
704673|NCT00249873|B1|Baseline|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
704674|NCT00249873|P2|Participant Flow|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
704675|NCT00249873|P1|Participant Flow|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
704676|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
704677|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
704678|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
704679|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
704680|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
704681|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
704682|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
704683|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
704684|NCT00249873|E2|Reported Event|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
704685|NCT00249873|E1|Reported Event|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
704686|NCT00249834|B9|Baseline|Total|Total of all reporting groups
704687|NCT00249834|B8|Baseline|Gonal-f 300 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704688|NCT00249834|B7|Baseline|Gonal-f 262.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704689|NCT00249834|B6|Baseline|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704690|NCT00249834|B5|Baseline|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704691|NCT00249834|B4|Baseline|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704692|NCT00249834|B3|Baseline|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704693|NCT00249834|B2|Baseline|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704694|NCT00249834|B1|Baseline|Gonal-f 37.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704866|NCT00249288|B3|Baseline|Total|Total of all reporting groups
704867|NCT00249288|B2|Baseline|Folate|Patients underwent a 12 week trial of folate 2 mg/d
704695|NCT00249834|P8|Participant Flow|Gonal-f 300 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704696|NCT00249834|P7|Participant Flow|Gonal-f 262.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704697|NCT00249834|P6|Participant Flow|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704698|NCT00249834|P5|Participant Flow|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704699|NCT00249834|P4|Participant Flow|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704700|NCT00249834|P3|Participant Flow|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704701|NCT00249834|P2|Participant Flow|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704702|NCT00249834|P1|Participant Flow|Gonal-f 37.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 International Units (IU) per day based on assisted reproductive technology (ART) treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter were developed, a single injection of 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) was administered.
704703|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704704|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704705|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704706|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704707|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704708|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704709|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704710|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704868|NCT00249288|B1|Baseline|Placebo|Participants received 2 mg/daily of placebo, for 12 weeks
704711|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704712|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704713|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704714|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704715|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704716|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704717|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704718|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704719|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704720|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704721|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704722|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704723|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704724|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704725|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704726|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704772|NCT00249808|P1|Participant Flow|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
704727|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704728|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704729|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704730|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704731|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704732|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704733|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704734|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704735|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704736|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704737|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704738|NCT00249834|O5|Outcome|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704739|NCT00249834|O4|Outcome|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704740|NCT00249834|O3|Outcome|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704741|NCT00249834|O2|Outcome|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704742|NCT00249834|O1|Outcome|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704773|NCT00249808|O1|Outcome|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
704743|NCT00249834|E5|Reported Event|Gonal-f 225 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704744|NCT00249834|E4|Reported Event|Gonal-f 187.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704745|NCT00249834|E3|Reported Event|Gonal-f 150 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704746|NCT00249834|E2|Reported Event|Gonal-f 112.5 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704747|NCT00249834|E1|Reported Event|Gonal-f 75 IU|GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
704748|NCT00249821|B3|Baseline|Total|Total of all reporting groups
704749|NCT00249821|B2|Baseline|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704750|NCT00249821|B1|Baseline|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704751|NCT00249821|P2|Participant Flow|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704752|NCT00249821|P1|Participant Flow|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704753|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704754|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704755|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704756|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704757|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704758|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704759|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704760|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704761|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704762|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704763|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704764|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704765|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704766|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704767|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704768|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704769|NCT00249821|E2|Reported Event|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
704770|NCT00249821|E1|Reported Event|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
704771|NCT00249808|B1|Baseline|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
704775|NCT00249808|O1|Outcome|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
704776|NCT00249808|E1|Reported Event|Efalizumab|Participants received efalizumab 1.0 mg/kg (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (FT). Depending on the response at Week 12, participants could have received additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.
704777|NCT00249795|B3|Baseline|Total|Total of all reporting groups
704778|NCT00249795|B2|Baseline|Placebo|matching placebo up to final follow-up visit
704779|NCT00249795|B1|Baseline|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704780|NCT00249795|P2|Participant Flow|Placebo|matching placebo up to final follow-up visit
704781|NCT00249795|P1|Participant Flow|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704782|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
704783|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704784|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
704785|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704786|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
704787|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704788|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
704789|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704790|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
704791|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704792|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
704793|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704794|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
704795|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704796|NCT00249795|E2|Reported Event|Placebo|matching placebo up to final follow-up visit
704797|NCT00249795|E1|Reported Event|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
704798|NCT00249613|B3|Baseline|Total|Total of all reporting groups
704799|NCT00249613|B2|Baseline|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment for women and men
704800|NCT00249613|B1|Baseline|Women-Only Treatment 152 Subjects|Out-patient gender-responsive substance abuse treatment for women only
704801|NCT00249613|P2|Participant Flow|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment that included both women and men
704802|NCT00249613|P1|Participant Flow|Women-Only Treatment 152 Subjects|Out patient gender-responsive substance abuse treatment for women only
704803|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender|Comparison of outcome in Women-Only vs. Mixed-Gender treatment
704804|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender)|Outpatient gender-responsive substance abuse treatment for women only vs. outpatient mixed-gender substance abuse treatment
704805|NCT00249613|O1|Outcome|Women-Only Compared to Mixed-Gender|Outpatient gender-responsive substance abuse treatment for women only compared to outpatient substance abuse treatment for women and men
704806|NCT00249613|O2|Outcome|Mixed-Gender|Substance abuse treatment program for both women and men
704807|NCT00249613|O1|Outcome|Women-Only|"Substance abuse treatment program for women only~Women-Only: Gender-responsive treatment for women only"
704808|NCT00249613|E2|Reported Event|Mixed-Gender|Outpatient mixed-gender substance abuse treatment
704809|NCT00249613|E1|Reported Event|Women-Only|Outpatient gender-responsive substance abuse treatment for women only
704810|NCT00249496|B3|Baseline|Total|Total of all reporting groups
704811|NCT00249496|B2|Baseline|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
704812|NCT00249496|B1|Baseline|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
704813|NCT00249496|P2|Participant Flow|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
704814|NCT00249496|P1|Participant Flow|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
704815|NCT00249496|O2|Outcome|Contingency Management|Participants in the Contingency Management group were employed for one year in a Therapeutic Workplace business and had to provide drug-free urine samples to work and earn salary.
704816|NCT00249496|O1|Outcome|Employment Only|Employment Only participants were offered employment for one year, but these participants did not have to provide drug-free urine samples to work.
704869|NCT00249288|P2|Participant Flow|Placebo|
704870|NCT00249288|P1|Participant Flow|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
704871|NCT00249288|O2|Outcome|Not Deficit Syndrome|Participants without deficit syndrome
704872|NCT00249288|O1|Outcome|Deficit Syndrome|Study participants with deficit syndrome
704817|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
704818|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
704819|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
704820|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
704821|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
704822|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
704823|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
704824|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
704825|NCT00249496|E2|Reported Event|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
704826|NCT00249496|E1|Reported Event|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
704827|NCT00249470|B3|Baseline|Total|Total of all reporting groups
704828|NCT00249470|B2|Baseline|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
704829|NCT00249470|B1|Baseline|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
704830|NCT00249470|P2|Participant Flow|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
704831|NCT00249470|P1|Participant Flow|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
704832|NCT00249470|O2|Outcome|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
704833|NCT00249470|O1|Outcome|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
704834|NCT00249470|O2|Outcome|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
704835|NCT00249470|O1|Outcome|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
704836|NCT00249470|O2|Outcome|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
704837|NCT00249470|O1|Outcome|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
704838|NCT00249470|E2|Reported Event|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
704839|NCT00249470|E1|Reported Event|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
704840|NCT00249444|B3|Baseline|Total|Total of all reporting groups
704841|NCT00249444|B2|Baseline|Placebo|"placebo~Placebo: placebo"
704842|NCT00249444|B1|Baseline|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
704843|NCT00249444|P2|Participant Flow|Placebo|"placebo~Placebo: placebo"
704844|NCT00249444|P1|Participant Flow|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
704845|NCT00249444|O2|Outcome|Placebo|"placebo~Placebo: placebo"
704846|NCT00249444|O1|Outcome|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
704847|NCT00249444|O2|Outcome|Placebo|"placebo~Placebo: placebo"
704848|NCT00249444|O1|Outcome|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
704849|NCT00249444|E2|Reported Event|Placebo|"placebo~Placebo: placebo"
704850|NCT00249444|E1|Reported Event|Mirtazapine|"Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose.~Mirtazapine: Mirtazapine"
704851|NCT00249379|B3|Baseline|Total|Total of all reporting groups
704852|NCT00249379|B2|Baseline|Control|No specific intervention, monitored for outcomes
704853|NCT00249379|B1|Baseline|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
704854|NCT00249379|P2|Participant Flow|Control|No specific intervention, received standard Drug Court counseling, monitored for outcomes
704855|NCT00249379|P1|Participant Flow|Acamprosate|Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period
704856|NCT00249379|O2|Outcome|Control|
704857|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
704858|NCT00249379|O2|Outcome|Control|
704859|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
704860|NCT00249379|O2|Outcome|Control|
704861|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
704862|NCT00249379|O2|Outcome|Control|
704863|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
704876|NCT00249288|O1|Outcome|Deficit Syndrome|Study participants with deficit syndrome
704877|NCT00249288|O1|Outcome|Overall|All study participants at baseline
704878|NCT00249288|O1|Outcome|Overall|All study participants at baseline
704879|NCT00249288|O1|Outcome|Overall|All study participants at baseline
704880|NCT00249288|O2|Outcome|T- Genotype|Participants with MTHFR genotype T (T allele carrier)
704881|NCT00249288|O1|Outcome|CC Genotype|Study participants with MTHFR genotype CC
704882|NCT00249288|O2|Outcome|T- Genotype|Participants with MTHFR genotype T (T allele carrier)
704883|NCT00249288|O1|Outcome|CC Genotype|Study participants with MTHFR genotype CC
704884|NCT00249288|O3|Outcome|Never Smoker|Participants with never smoker status
704885|NCT00249288|O2|Outcome|Past Smoker|Participants with past smoker status
704886|NCT00249288|O1|Outcome|Current Smoker|Study participants with current smoker status
704887|NCT00249288|O3|Outcome|Never Smoker|Participants with never smoker status
704888|NCT00249288|O2|Outcome|Past Smoker|Participants with past smoker status
704889|NCT00249288|O1|Outcome|Current Smoker|Study participants with current smoker status
704890|NCT00249288|O2|Outcome|Placebo|"Participants will receive a 2 mg/ day dose of placebo, for 12 weeks~Placebo: Placebo taken by mouth daily as 2, 1mg capsule daily for 12 weeks"
704891|NCT00249288|O1|Outcome|Folate|"Participants will receive a 2 mg/ day dose of folate, for 12 weeks~Folate: Folic acid taken as 2, 1mg capsule daily for 12 weeks"
704892|NCT00249288|O1|Outcome|Overall|All study participants at baseline
704893|NCT00249288|O2|Outcome|T- Genotype|Participants with MTHFR genotype T (T allele carrier)
704894|NCT00249288|O1|Outcome|CC Genotype|Study participants with MTHFR genotype CC
704895|NCT00249288|O3|Outcome|Never Smoker|Participants with never smoker status
704896|NCT00249288|O2|Outcome|Past Smoker|Participants with past smoker status
704897|NCT00249288|O1|Outcome|Current Smoker|Study participants with current smoker status
704898|NCT00249288|E2|Reported Event|Placebo|Participants receiving 2mg/daily of placebo, for 12 weeks
704899|NCT00249288|E1|Reported Event|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
704900|NCT00249249|B5|Baseline|Total|Total of all reporting groups
704901|NCT00249249|B4|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704902|NCT00249249|B3|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704903|NCT00249249|B2|Baseline|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704904|NCT00249249|B1|Baseline|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704905|NCT00249249|P4|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704906|NCT00249249|P3|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704907|NCT00249249|P2|Participant Flow|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704908|NCT00249249|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704909|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704910|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704911|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704912|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704913|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704914|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704915|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704916|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704917|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704918|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704919|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704920|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704921|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704922|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704923|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704924|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704925|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704926|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704927|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704928|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704929|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704930|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704931|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704932|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704933|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704934|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704935|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704936|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704937|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704938|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704939|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704940|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704941|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704942|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704943|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704944|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704945|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704946|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704947|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704948|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704949|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704951|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704952|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704953|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704954|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704955|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704956|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704957|NCT00249249|E4|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
704958|NCT00249249|E3|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
704959|NCT00249249|E2|Reported Event|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
704960|NCT00249249|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
704961|NCT00249002|B1|Baseline|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704962|NCT00249002|P1|Participant Flow|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704963|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704964|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704965|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704966|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704967|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704968|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704969|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704970|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704971|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704972|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704973|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704974|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704975|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704976|NCT00249002|E1|Reported Event|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
704977|NCT00248807|B3|Baseline|Total|Total of all reporting groups
704978|NCT00248807|B2|Baseline|Non-spinal Cord Injured Subjects|Non-spinal cord injured subjects underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
704979|NCT00248807|B1|Baseline|Subjects With Spinal Cord Injury|Subjects with spinal cord injury underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
704980|NCT00248807|P2|Participant Flow|Subjects Without SCI (Non-SCI)|Subjects without SCI (non-SCI) underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
704981|NCT00248807|P1|Participant Flow|Subjects With Spinal Cord Injury (SCI)|Subjects with SCI underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
704982|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
704983|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
704984|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug.
704985|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug.
704986|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
704987|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
705021|NCT00248781|B1|Baseline|Arm 1|Telecommunications system for exercise
704988|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug
704989|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug
704990|NCT00248807|E4|Reported Event|ARM 4|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
704991|NCT00248807|E3|Reported Event|ARM 3|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
704992|NCT00248807|E2|Reported Event|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
704993|NCT00248807|E1|Reported Event|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
704994|NCT00248794|B4|Baseline|Total|Total of all reporting groups
704995|NCT00248794|B3|Baseline|Skills Group Only|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
704996|NCT00248794|B2|Baseline|ICBCR + Skills Group|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
704997|NCT00248794|B1|Baseline|CRT +Skills Group|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
704998|NCT00248794|P3|Participant Flow|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
704999|NCT00248794|P2|Participant Flow|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
705000|NCT00248794|P1|Participant Flow|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
705001|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
705002|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705003|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705004|NCT00248794|O3|Outcome|Skills Group Control|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
705005|NCT00248794|O2|Outcome|ICBCR and Skills Training|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
705006|NCT00248794|O1|Outcome|CRT + Skills Training|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
705007|NCT00248794|O3|Outcome|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
705008|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
705009|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
705010|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
705011|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705012|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705013|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
705014|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705015|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705016|NCT00248794|E3|Reported Event|Skills Group + Generic Contact|Life skills group + up to five individual contacts with research staff without active cognitive training
705017|NCT00248794|E2|Reported Event|ICBCR + Skills Group|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705018|NCT00248794|E1|Reported Event|CRT+Skills Group|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
705019|NCT00248781|B3|Baseline|Total|Total of all reporting groups
705020|NCT00248781|B2|Baseline|Arm 2|attention control (health education)
705022|NCT00248781|P2|Participant Flow|Attention Control Group|attention control (health education)
705023|NCT00248781|P1|Participant Flow|Automated Exercise Group|Telecommunications system for exercise
705024|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705025|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705026|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705027|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705028|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705029|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705030|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705031|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705032|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705033|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705034|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705035|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705036|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705037|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705038|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705039|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705040|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705041|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705042|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
705043|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
705044|NCT00248781|E2|Reported Event|Attention Control Group|attention control (health education)
705045|NCT00248781|E1|Reported Event|Automated Exercise Group|Telecommunications system for exercise
705046|NCT00248651|B4|Baseline|Total|Total of all reporting groups
705047|NCT00248651|B3|Baseline|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
705048|NCT00248651|B2|Baseline|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
705049|NCT00248651|B1|Baseline|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
705050|NCT00248651|P3|Participant Flow|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
705051|NCT00248651|P2|Participant Flow|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
705052|NCT00248651|P1|Participant Flow|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
705053|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
705054|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
705055|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
705056|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
705057|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
705058|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
705059|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
705060|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
705061|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
705062|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
705063|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
705064|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
705376|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705065|NCT00248651|E3|Reported Event|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
705066|NCT00248651|E2|Reported Event|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
705067|NCT00248651|E1|Reported Event|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
705068|NCT00248638|B3|Baseline|Total|Total of all reporting groups
705069|NCT00248638|B2|Baseline|Standard|Participants given standard nutrition without glutamine dipeptide
705070|NCT00248638|B1|Baseline|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
705071|NCT00248638|P2|Participant Flow|Standard|Participants given standard nutrition without glutamine dipeptide
705072|NCT00248638|P1|Participant Flow|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
705073|NCT00248638|O2|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705074|NCT00248638|O1|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705075|NCT00248638|O2|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705076|NCT00248638|O1|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705077|NCT00248638|O2|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705078|NCT00248638|O1|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705096|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705314|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705079|NCT00248638|O2|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705080|NCT00248638|O1|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
705081|NCT00248638|O2|Outcome|Standard|Participants given standard nutrition without glutamine dipeptide
705082|NCT00248638|O1|Outcome|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
705083|NCT00248638|E2|Reported Event|Standard|Participants given standard nutrition without glutamine dipeptide
705084|NCT00248638|E1|Reported Event|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
705085|NCT00248625|B3|Baseline|Total|Total of all reporting groups
705086|NCT00248625|B2|Baseline|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705087|NCT00248625|B1|Baseline|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705088|NCT00248625|P2|Participant Flow|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
705089|NCT00248625|P1|Participant Flow|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to placebo consisting of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications."
705090|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705091|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705092|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705093|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705094|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705095|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705960|NCT00245518|E2|Reported Event|Placebo|Placebos
705097|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705098|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705099|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705100|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705101|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705102|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705103|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705104|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
705105|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
705106|NCT00248625|E2|Reported Event|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization."
705107|NCT00248625|E1|Reported Event|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
705108|NCT00248612|B5|Baseline|Total|Total of all reporting groups
705109|NCT00248612|B4|Baseline|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705110|NCT00248612|B3|Baseline|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705111|NCT00248612|B2|Baseline|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705112|NCT00248612|B1|Baseline|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705113|NCT00248612|P4|Participant Flow|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705114|NCT00248612|P3|Participant Flow|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705115|NCT00248612|P2|Participant Flow|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705116|NCT00248612|P1|Participant Flow|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper. They will also receive tailored cognitive behavioral training (CBT)
705117|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705118|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705150|NCT00248612|O3|Outcome|Venlafaxine & PMR|Placebo medication and PMR (progressive muscle relaxation therapy).
705119|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705120|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705121|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705122|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705123|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705124|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705125|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705126|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705127|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705128|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705129|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705130|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705131|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705132|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705133|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705134|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705135|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705136|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705137|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705138|NCT00248612|O3|Outcome|Venlafaxine & PMR|Venlafaxine and PMR (progressive muscle relaxation therapy).
705139|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705140|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR) and CBT (Cognitive Behavioral therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705141|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705142|NCT00248612|O3|Outcome|Venlafaxine & PMR|Placebo medication and PMR (progressive muscle relaxation therapy).
705143|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705144|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705145|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705146|NCT00248612|O3|Outcome|Venlafaxine & PMR|Placebo medication and PMR (progressive muscle relaxation therapy).
705147|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705148|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705149|NCT00248612|O4|Outcome|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705151|NCT00248612|O2|Outcome|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705152|NCT00248612|O1|Outcome|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705153|NCT00248612|E4|Reported Event|Placebo & PMR|Placebo medication and PMR (progressive muscle relaxation therapy)
705154|NCT00248612|E3|Reported Event|Venlafaxine & PMR|Venlafaxine medication and PMR (progressive muscle relaxation therapy).
705155|NCT00248612|E2|Reported Event|Placebo & CBT|Placebo and CBT (Cognitive Behavioral Therapy): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.
705156|NCT00248612|E1|Reported Event|Venlafaxine & CBT|Venlafaxine (Effexor XR): Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.
705157|NCT00248560|B1|Baseline|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
705158|NCT00248560|P1|Participant Flow|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
705159|NCT00248560|O1|Outcome|Gemcitabine Hydrochloride, Docetaxel|Gemcitabine hydrochloride given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine hydrochloride.
705160|NCT00248560|E1|Reported Event|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
705161|NCT00248547|B3|Baseline|Total|Total of all reporting groups
705162|NCT00248547|B2|Baseline|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705163|NCT00248547|B1|Baseline|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705164|NCT00248547|P2|Participant Flow|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705165|NCT00248547|P1|Participant Flow|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705166|NCT00248547|O2|Outcome|Placebo (Sugar Pill)|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705167|NCT00248547|O1|Outcome|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705168|NCT00248547|E2|Reported Event|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705169|NCT00248547|E1|Reported Event|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
705170|NCT00248495|B1|Baseline|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705171|NCT00248495|P1|Participant Flow|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705172|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705173|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705174|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705175|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705176|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705177|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705236|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705315|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705178|NCT00248495|E1|Reported Event|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
705179|NCT00248287|B3|Baseline|Total|Total of all reporting groups
705180|NCT00248287|B2|Baseline|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
705181|NCT00248287|B1|Baseline|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
705182|NCT00248287|P2|Participant Flow|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
705183|NCT00248287|P1|Participant Flow|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
705184|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
705185|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
705186|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
705187|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
705188|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
705189|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
705190|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
705191|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
705192|NCT00248287|E2|Reported Event|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
705193|NCT00248287|E1|Reported Event|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
705194|NCT00248170|B3|Baseline|Total|Total of all reporting groups
705195|NCT00248170|B2|Baseline|Anastrozole|1 mg p.o. once daily
705196|NCT00248170|B1|Baseline|Letrozole|2.5 mg by mouth (p.o.) once daily
705197|NCT00248170|P2|Participant Flow|Anastrozole|1 mg p.o. once daily
705198|NCT00248170|P1|Participant Flow|Letrozole|2.5 mg by mouth (p.o.) once daily
705199|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705200|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705201|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705202|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705203|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705204|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705205|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705206|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705207|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705208|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705209|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705210|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705211|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705212|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705213|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
705214|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
705215|NCT00248170|E2|Reported Event|Anastrozole|Anastrozole
705216|NCT00248170|E1|Reported Event|Letrozole|Letrozole
705217|NCT00247962|B3|Baseline|Total|Total of all reporting groups
705218|NCT00247962|B2|Baseline|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
705219|NCT00247962|B1|Baseline|Etanercept|etanercept 50 mg once weekly
705220|NCT00247962|P2|Participant Flow|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
705221|NCT00247962|P1|Participant Flow|Etanercept|etanercept 50 mg once weekly
705222|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
705223|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
705224|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
705225|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
705226|NCT00247962|E2|Reported Event|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
705227|NCT00247962|E1|Reported Event|Etanercept|etanercept 50 mg once weekly
705228|NCT00247676|B1|Baseline|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705229|NCT00247676|P1|Participant Flow|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705230|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705231|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705232|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705233|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705234|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705235|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705237|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705238|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705239|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705240|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705241|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705242|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705243|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705244|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705245|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705246|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705247|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705248|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705249|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705250|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705251|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705252|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705253|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705254|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705255|NCT00247676|E1|Reported Event|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
705256|NCT00247624|B3|Baseline|Total|Total of all reporting groups
705257|NCT00247624|B2|Baseline|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
705258|NCT00247624|B1|Baseline|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
705259|NCT00247624|P2|Participant Flow|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
705260|NCT00247624|P1|Participant Flow|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
705261|NCT00247624|O2|Outcome|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
705262|NCT00247624|O1|Outcome|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
705263|NCT00247624|O2|Outcome|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
705264|NCT00247624|O1|Outcome|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
705265|NCT00247624|O2|Outcome|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
705266|NCT00247624|O1|Outcome|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
705267|NCT00247624|O2|Outcome|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
705268|NCT00247624|O1|Outcome|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
705269|NCT00247624|E2|Reported Event|FLX Plus Placebo|Participants will receive treatment with placebo and fluoxetine
705270|NCT00247624|E1|Reported Event|Fluoxetine (FLX) Plus Eszopiclone (ESZ)|Participants will receive treatment with eszopiclone and fluoxetine
705271|NCT00247611|B3|Baseline|Total|Total of all reporting groups
705272|NCT00247611|B2|Baseline|Intervention|Participants will receive the LifeWindows Intervention sessions
705273|NCT00247611|B1|Baseline|Control|Participants will receive the control condition
705274|NCT00247611|P2|Participant Flow|Intervention|Participants will receive the LifeWindows Intervention sessions
705275|NCT00247611|P1|Participant Flow|Control|Participants will receive the control condition
705312|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705276|NCT00247611|O2|Outcome|Total Excluded From OP Sample|ITT sample excluded from the post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions (ITT - OP sample)
705277|NCT00247611|O1|Outcome|On Protocol (OP) Sample|Post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions
705278|NCT00247611|O4|Outcome|Intervention (On Protocol Sample)|152 (55%) of the ITT included intervention arm participants
705279|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
705280|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
705281|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
705282|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
705283|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
705284|NCT00247611|O4|Outcome|Intervention (On Protocol)|152 (55%) of the ITT included intervention arm participants
705285|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
705286|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
705287|NCT00247611|O1|Outcome|Control (ITT Sample %)|287 (94%) of the 304 randomized to control
705288|NCT00247611|E2|Reported Event|Intervention|Participants will receive the LifeWindows Intervention sessions
705289|NCT00247611|E1|Reported Event|Control|Participants will receive the control condition
705290|NCT00247416|B3|Baseline|Total|Total of all reporting groups
705291|NCT00247416|B2|Baseline|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
705292|NCT00247416|B1|Baseline|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
705293|NCT00247416|P2|Participant Flow|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
705294|NCT00247416|P1|Participant Flow|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
705295|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
705296|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
705297|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
705298|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
705299|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
705300|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
705301|NCT00247416|O2|Outcome|2 Dex|"Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
705302|NCT00247416|O1|Outcome|1 No Dex|"No Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
705303|NCT00247416|E2|Reported Event|2 Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
705304|NCT00247416|E1|Reported Event|1 No Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
705305|NCT00247377|B3|Baseline|Total|Total of all reporting groups
705306|NCT00247377|B2|Baseline|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705307|NCT00247377|B1|Baseline|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705308|NCT00247377|P2|Participant Flow|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705309|NCT00247377|P1|Participant Flow|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705310|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705311|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705313|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705316|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705317|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705318|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705319|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705320|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705321|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705322|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705323|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705324|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705325|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705326|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705327|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705328|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705329|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705330|NCT00247377|E2|Reported Event|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
705331|NCT00247377|E1|Reported Event|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
705332|NCT00247273|B3|Baseline|Total|Total of all reporting groups
705333|NCT00247273|B2|Baseline|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705334|NCT00247273|B1|Baseline|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705335|NCT00247273|P2|Participant Flow|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705336|NCT00247273|P1|Participant Flow|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705337|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705338|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705339|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705340|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705341|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705342|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705343|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705344|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705345|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705346|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705347|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705348|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705349|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705350|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705351|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705352|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705353|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705354|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705355|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705356|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705357|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705358|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705359|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705360|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705361|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705362|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705363|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705364|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705365|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705366|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705367|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705368|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705369|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705370|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705371|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705372|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705373|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705374|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705375|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705377|NCT00247273|E2|Reported Event|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
705378|NCT00247273|E1|Reported Event|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
705379|NCT00246805|B3|Baseline|Total|Total of all reporting groups
705380|NCT00246805|B2|Baseline|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705381|NCT00246805|B1|Baseline|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705382|NCT00246805|P2|Participant Flow|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705383|NCT00246805|P1|Participant Flow|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705384|NCT00246805|O2|Outcome|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705385|NCT00246805|O1|Outcome|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705386|NCT00246805|E2|Reported Event|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705387|NCT00246805|E1|Reported Event|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
705388|NCT00246753|B1|Baseline|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
705389|NCT00246753|P1|Participant Flow|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
705390|NCT00246753|O1|Outcome|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
705391|NCT00246753|O1|Outcome|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
705392|NCT00246753|O1|Outcome|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
705393|NCT00246753|E1|Reported Event|Single Arm Trial|"Single Arm Trial~lapatinib ditosylate: 1500 mg, daily until disease progression"
705394|NCT00246740|B3|Baseline|Total|Total of all reporting groups
705395|NCT00246740|B2|Baseline|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705396|NCT00246740|B1|Baseline|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705397|NCT00246740|P2|Participant Flow|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705398|NCT00246740|P1|Participant Flow|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705399|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705400|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705401|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705402|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705403|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705404|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705405|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705406|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705407|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705408|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705409|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705410|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705411|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705412|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705413|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705414|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705415|NCT00246740|O2|Outcome|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705416|NCT00246740|O1|Outcome|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705417|NCT00246740|E2|Reported Event|Periostat|"Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705418|NCT00246740|E1|Reported Event|Placebo Oral Tablet|"Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).~Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3."
705419|NCT00246571|B3|Baseline|Total|Total of all reporting groups
705465|NCT00246519|O2|Outcome|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
705420|NCT00246571|B2|Baseline|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705421|NCT00246571|B1|Baseline|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705422|NCT00246571|P2|Participant Flow|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705423|NCT00246571|P1|Participant Flow|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705424|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705425|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705426|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705427|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705428|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705429|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705430|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705431|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705432|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705466|NCT00246519|O1|Outcome|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
705433|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705434|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705435|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705436|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705437|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705438|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705439|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705440|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705441|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705442|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705443|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705444|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705445|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705446|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705447|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705467|NCT00246519|E2|Reported Event|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
705468|NCT00246519|E1|Reported Event|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
705469|NCT00246376|B6|Baseline|Total|Total of all reporting groups
705470|NCT00246376|B5|Baseline|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
705448|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705449|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705450|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705451|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705452|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705453|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705454|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705455|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705456|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705457|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705458|NCT00246571|E2|Reported Event|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
705459|NCT00246571|E1|Reported Event|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
705460|NCT00246519|B3|Baseline|Total|Total of all reporting groups
705461|NCT00246519|B2|Baseline|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
705462|NCT00246519|B1|Baseline|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
705463|NCT00246519|P2|Participant Flow|Hydrochlorothiazide (HCTZ) + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
705464|NCT00246519|P1|Participant Flow|Atenolol + Hydroclorothiazide (HCTZ) Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
705961|NCT00245518|E1|Reported Event|Isoflavone|"Isoflavone~Isoflavone"
705471|NCT00246376|B4|Baseline|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
705472|NCT00246376|B3|Baseline|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
705473|NCT00246376|B2|Baseline|Group 2: Diet / Exercise|Diet, exercise, and two placebos
705474|NCT00246376|B1|Baseline|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
705475|NCT00246376|P5|Participant Flow|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
705476|NCT00246376|P4|Participant Flow|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
705477|NCT00246376|P3|Participant Flow|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
705478|NCT00246376|P2|Participant Flow|Group 2: Diet / Exercise|Diet, exercise, and two placebos
705479|NCT00246376|P1|Participant Flow|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
705480|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
705481|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
705482|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
705483|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
705484|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
705485|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
705486|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
705487|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
705488|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
705489|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
705490|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
705491|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
705492|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
705493|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
705494|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
705495|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
705496|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
705497|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
705498|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
705499|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
705500|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
705501|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
705502|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
705503|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise|
705504|NCT00246376|O1|Outcome|Group 1 - Usual Care|
705505|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
705506|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
705507|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
705508|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|
705509|NCT00246376|O1|Outcome|Group 1 - Usual Care|
705510|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
705511|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
705512|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
705513|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
705514|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
705515|NCT00246376|E5|Reported Event|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
705516|NCT00246376|E4|Reported Event|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
705517|NCT00246376|E3|Reported Event|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
705518|NCT00246376|E2|Reported Event|Group 2: Diet / Exercise|Diet, exercise, and two placebos
705519|NCT00246376|E1|Reported Event|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
705520|NCT00246337|B10|Baseline|Total|Total of all reporting groups
705521|NCT00246337|B9|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705643|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705522|NCT00246337|B8|Baseline|MK0974 600 mg|"MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705523|NCT00246337|B7|Baseline|MK0974 400 mg|"MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705524|NCT00246337|B6|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705525|NCT00246337|B5|Baseline|MK0974 200 mg|"MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705526|NCT00246337|B4|Baseline|MK0974 100 mg|"MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705527|NCT00246337|B3|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705528|NCT00246337|B2|Baseline|MK0974 25 mg|"MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705529|NCT00246337|B1|Baseline|Placebo|"Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
705530|NCT00246337|P9|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705531|NCT00246337|P8|Participant Flow|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705532|NCT00246337|P7|Participant Flow|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705533|NCT00246337|P6|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705534|NCT00246337|P5|Participant Flow|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705535|NCT00246337|P4|Participant Flow|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705536|NCT00246337|P3|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705537|NCT00246337|P2|Participant Flow|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705538|NCT00246337|P1|Participant Flow|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
705539|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705540|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705541|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705542|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705543|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705544|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705545|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705546|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705547|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
705548|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705549|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705550|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705551|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705552|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705553|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705554|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705555|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705556|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
705557|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705558|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705559|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705560|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705561|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705562|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705563|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705564|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705565|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
705566|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705567|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705568|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705569|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705570|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705571|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705572|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705573|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705574|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
705575|NCT00246337|E9|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705576|NCT00246337|E8|Reported Event|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705577|NCT00246337|E7|Reported Event|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705578|NCT00246337|E6|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705579|NCT00246337|E5|Reported Event|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705580|NCT00246337|E4|Reported Event|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705581|NCT00246337|E3|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705582|NCT00246337|E2|Reported Event|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
705583|NCT00246337|E1|Reported Event|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
705584|NCT00246324|B1|Baseline|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
705585|NCT00246324|P1|Participant Flow|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
705586|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
705587|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
705962|NCT00245466|B4|Baseline|Total|Total of all reporting groups
705588|NCT00246324|E1|Reported Event|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
705589|NCT00246259|B3|Baseline|Total|Total of all reporting groups
705590|NCT00246259|B2|Baseline|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705591|NCT00246259|B1|Baseline|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705592|NCT00246259|P2|Participant Flow|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705593|NCT00246259|P1|Participant Flow|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705594|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705595|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705596|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705597|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705598|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705599|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705600|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705601|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705602|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705603|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705604|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705605|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705606|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705607|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705608|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705609|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705610|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705644|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705611|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705612|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705613|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705614|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705615|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705616|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705617|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705618|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705619|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705620|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705621|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705622|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705623|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705624|NCT00246259|E2|Reported Event|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
705625|NCT00246259|E1|Reported Event|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
705626|NCT00246090|B1|Baseline|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
705627|NCT00246090|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
705628|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
705629|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
705630|NCT00246090|E1|Reported Event|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
705631|NCT00246025|B5|Baseline|Total|Total of all reporting groups
705632|NCT00246025|B4|Baseline|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705633|NCT00246025|B3|Baseline|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705634|NCT00246025|B2|Baseline|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705635|NCT00246025|B1|Baseline|Treatment Group With Placebo|Patients were treated with matching Placebo.
705636|NCT00246025|P4|Participant Flow|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705637|NCT00246025|P3|Participant Flow|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705638|NCT00246025|P2|Participant Flow|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705639|NCT00246025|P1|Participant Flow|Treatment Group With Placebo|Patients were treated with matching Placebo.
705640|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705641|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705642|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705645|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705646|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705647|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705648|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705649|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705650|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705651|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705652|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705653|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705654|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705655|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705656|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705657|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705658|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705659|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705660|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705661|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705662|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705663|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705664|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705665|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705666|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705667|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705668|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705669|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705670|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705671|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705672|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705673|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705674|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705675|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705676|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705677|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705678|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705679|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705680|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705681|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705682|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705683|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
705684|NCT00246025|E4|Reported Event|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
705685|NCT00246025|E3|Reported Event|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
705686|NCT00246025|E2|Reported Event|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
705687|NCT00246025|E1|Reported Event|Treatment Group With Placebo|Patients were treated with matching Placebo.
705688|NCT00246012|B10|Baseline|Total|Total of all reporting groups
705689|NCT00246012|B9|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705690|NCT00246012|B8|Baseline|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705691|NCT00246012|B7|Baseline|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705692|NCT00246012|B6|Baseline|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705693|NCT00246012|B5|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705694|NCT00246012|B4|Baseline|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705695|NCT00246012|B3|Baseline|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705696|NCT00246012|B2|Baseline|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705697|NCT00246012|B1|Baseline|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705698|NCT00246012|P9|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705699|NCT00246012|P8|Participant Flow|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705700|NCT00246012|P7|Participant Flow|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705701|NCT00246012|P6|Participant Flow|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705702|NCT00246012|P5|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705703|NCT00246012|P4|Participant Flow|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705704|NCT00246012|P3|Participant Flow|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705705|NCT00246012|P2|Participant Flow|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705732|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705706|NCT00246012|P1|Participant Flow|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705707|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705708|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705709|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705710|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705711|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705712|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705713|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705714|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705715|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705716|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705717|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705718|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705733|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705719|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705720|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705721|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705722|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705723|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705724|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705725|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705726|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705727|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705728|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705729|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705730|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705731|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705766|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
707766|NCT00236197|E1|Reported Event|Placebo|
705734|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705735|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705736|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705737|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705738|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705739|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705740|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705741|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705742|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705743|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705744|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705745|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705746|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705747|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705748|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705749|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705750|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705751|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705752|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705753|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705754|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705755|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705756|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705757|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705758|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705759|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705760|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705761|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705762|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705763|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705764|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705765|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705767|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705768|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705769|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705770|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705771|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705772|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705773|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705774|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705775|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705776|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705777|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705778|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705779|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705780|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705781|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705849|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705850|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705851|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705782|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705783|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705784|NCT00246012|O5|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705785|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705786|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705787|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705788|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705789|NCT00246012|E9|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705790|NCT00246012|E8|Reported Event|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705791|NCT00246012|E7|Reported Event|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
705792|NCT00246012|E6|Reported Event|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
705793|NCT00246012|E5|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705794|NCT00246012|E4|Reported Event|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
705795|NCT00246012|E3|Reported Event|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
705852|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705853|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705796|NCT00246012|E2|Reported Event|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705797|NCT00246012|E1|Reported Event|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
705798|NCT00245960|B3|Baseline|Total|Total of all reporting groups
705799|NCT00245960|B2|Baseline|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705800|NCT00245960|B1|Baseline|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705801|NCT00245960|P2|Participant Flow|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705802|NCT00245960|P1|Participant Flow|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705803|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705804|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705805|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705806|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705807|NCT00245960|E2|Reported Event|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705808|NCT00245960|E1|Reported Event|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
705809|NCT00245856|B1|Baseline|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
705810|NCT00245856|P2|Participant Flow|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
705811|NCT00245856|P1|Participant Flow|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
705812|NCT00245856|O1|Outcome|Dalteparin + Warfarin/Dalteparin Alone|Major bleeding rates
705813|NCT00245856|O1|Outcome|Dalteparin + Warfarin or Dalteparin Alone|Patients with arm DVT who received either 3 months of dalteparin + warfarin (INR 2-3) or Dalteparin alone
705814|NCT00245856|O1|Outcome|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
705815|NCT00245856|E2|Reported Event|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
705816|NCT00245856|E1|Reported Event|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
705817|NCT00245635|B3|Baseline|Total|Total of all reporting groups
705818|NCT00245635|B2|Baseline|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
705819|NCT00245635|B1|Baseline|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
705820|NCT00245635|P2|Participant Flow|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
705821|NCT00245635|P1|Participant Flow|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
705822|NCT00245635|O2|Outcome|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
705823|NCT00245635|O1|Outcome|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
705824|NCT00245635|E2|Reported Event|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
705825|NCT00245635|E1|Reported Event|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
705826|NCT00245570|B1|Baseline|Overall Study Population|All randomized patients
705827|NCT00245570|P6|Participant Flow|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
705828|NCT00245570|P5|Participant Flow|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
705829|NCT00245570|P4|Participant Flow|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
705830|NCT00245570|P3|Participant Flow|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
705831|NCT00245570|P2|Participant Flow|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
705832|NCT00245570|P1|Participant Flow|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
705833|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705834|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705835|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705836|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705837|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705838|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705839|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705840|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705841|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705842|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705843|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705844|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705845|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705846|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705847|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705848|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705854|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705855|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705856|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705857|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705858|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705859|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705860|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705861|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705862|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705863|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705864|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705865|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705866|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
705867|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
705868|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
705869|NCT00245570|E6|Reported Event|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
705870|NCT00245570|E5|Reported Event|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
705871|NCT00245570|E4|Reported Event|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
705872|NCT00245570|E3|Reported Event|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
705873|NCT00245570|E2|Reported Event|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
705874|NCT00245570|E1|Reported Event|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
705875|NCT00245557|B3|Baseline|Total|Total of all reporting groups
705958|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705876|NCT00245557|B2|Baseline|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
705877|NCT00245557|B1|Baseline|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
705878|NCT00245557|P2|Participant Flow|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
705879|NCT00245557|P1|Participant Flow|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
705880|NCT00245557|O3|Outcome|Post-treatment Depressed|
705881|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
705882|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
705883|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
705884|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
705885|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
705886|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
705887|NCT00245557|E2|Reported Event|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
705888|NCT00245557|E1|Reported Event|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
705889|NCT00245518|B3|Baseline|Total|Total of all reporting groups
705890|NCT00245518|B2|Baseline|Placebo|Placebos
705891|NCT00245518|B1|Baseline|Isoflavone|"Isoflavone~Isoflavone"
705892|NCT00245518|P2|Participant Flow|Placebo|Placebos
705893|NCT00245518|P1|Participant Flow|Isoflavone|"Isoflavone~Isoflavone"
705894|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705895|NCT00245518|O1|Outcome|Placebo|Placebo
705896|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705897|NCT00245518|O1|Outcome|Placebo|Placebo
705898|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705899|NCT00245518|O1|Outcome|Placebo|Placebo
705900|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705901|NCT00245518|O1|Outcome|Placebo|Placebo
705902|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705903|NCT00245518|O1|Outcome|Placebo|Placebo
705904|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705905|NCT00245518|O1|Outcome|Placebo|Placebo
705906|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705907|NCT00245518|O1|Outcome|Placebo|Placebo
705908|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705909|NCT00245518|O1|Outcome|Placebo|Placebo
705910|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705911|NCT00245518|O1|Outcome|Placebo|Placebo
705912|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705913|NCT00245518|O1|Outcome|Placebo|Placebo
705914|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705915|NCT00245518|O1|Outcome|Placebo|Placebo
705916|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705917|NCT00245518|O1|Outcome|Placebo|Placebo
705918|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705919|NCT00245518|O1|Outcome|Placebo|Placebo
705920|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705921|NCT00245518|O1|Outcome|Placebo|Placebo
705922|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705923|NCT00245518|O1|Outcome|Placebo|Placebo
705924|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705925|NCT00245518|O1|Outcome|Placebo|Placebo
705926|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705927|NCT00245518|O1|Outcome|Placebo|Placebo
705928|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705929|NCT00245518|O1|Outcome|Placebo|Placebo
705930|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705931|NCT00245518|O1|Outcome|Placebo|Placebo
705932|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705933|NCT00245518|O1|Outcome|Placebo|Placebo
705934|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705935|NCT00245518|O1|Outcome|Placebo|Placebo
705936|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705937|NCT00245518|O1|Outcome|Placebo|Placebo
705938|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705939|NCT00245518|O1|Outcome|Placebo|Placebo
705940|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705941|NCT00245518|O1|Outcome|Placebo|Placebo
705942|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705943|NCT00245518|O1|Outcome|Placebo|Placebo
705944|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705945|NCT00245518|O1|Outcome|Placebo|Placebo
705946|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705947|NCT00245518|O1|Outcome|Placebo|Placebo
705948|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705949|NCT00245518|O1|Outcome|Placebo|Placebo
705950|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705951|NCT00245518|O1|Outcome|Placebo|Placebo
705952|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705953|NCT00245518|O1|Outcome|Placebo|Placebo
705954|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705955|NCT00245518|O1|Outcome|Placebo|Placebo
705956|NCT00245518|O2|Outcome|Isoflavone|"Isoflavone~Isoflavone"
705957|NCT00245518|O1|Outcome|Placebo|Placebo
705963|NCT00245466|B3|Baseline|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705964|NCT00245466|B2|Baseline|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705965|NCT00245466|B1|Baseline|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705966|NCT00245466|P3|Participant Flow|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705967|NCT00245466|P2|Participant Flow|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705968|NCT00245466|P1|Participant Flow|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705969|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705970|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705971|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705972|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705973|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705974|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705975|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705976|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705977|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705978|NCT00245466|E3|Reported Event|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705979|NCT00245466|E2|Reported Event|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705980|NCT00245466|E1|Reported Event|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
705981|NCT00245219|B4|Baseline|Total|Total of all reporting groups
705982|NCT00245219|B3|Baseline|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
705983|NCT00245219|B2|Baseline|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
705984|NCT00245219|B1|Baseline|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
705985|NCT00245219|P3|Participant Flow|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
705986|NCT00245219|P2|Participant Flow|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
705987|NCT00245219|P1|Participant Flow|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
705988|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
705989|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
705990|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
705991|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
705992|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
705993|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
705994|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
705995|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
705996|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
705997|NCT00245219|E3|Reported Event|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
705998|NCT00245219|E2|Reported Event|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
705999|NCT00245219|E1|Reported Event|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
706000|NCT00245128|B1|Baseline|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
706001|NCT00245128|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
706002|NCT00245128|O1|Outcome|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
706003|NCT00245128|E1|Reported Event|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
706004|NCT00245102|B7|Baseline|Total|Total of all reporting groups
706005|NCT00245102|B6|Baseline|Other Histology|Sorafenib 400 mg PO BID
706006|NCT00245102|B5|Baseline|Fibrosarcoma|Sorafenib 400 mg PO BID
706007|NCT00245102|B4|Baseline|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
706008|NCT00245102|B3|Baseline|Leiomyosarcoma|Sorafenib 400 mg PO BID
706009|NCT00245102|B2|Baseline|MPNST|Sorafenib 400 mg PO BID
706010|NCT00245102|B1|Baseline|Angiosarcoma|Sorafenib 400 mg PO BID
706011|NCT00245102|P6|Participant Flow|Other Histology|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
706012|NCT00245102|P5|Participant Flow|Fibrosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
706013|NCT00245102|P4|Participant Flow|Undifferentiated Pleomorphic Sarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
706014|NCT00245102|P3|Participant Flow|Leiomyosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
706015|NCT00245102|P2|Participant Flow|MPNST|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
706016|NCT00245102|P1|Participant Flow|Angiosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
706017|NCT00245102|O6|Outcome|Other Histology|Sorafenib 400 mg PO BID
706018|NCT00245102|O5|Outcome|Fibrosarcoma|Sorafenib 400 mg PO BID
706019|NCT00245102|O4|Outcome|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
706020|NCT00245102|O3|Outcome|Leiomyosarcoma|Sorafenib 400 mg PO BID
706021|NCT00245102|O2|Outcome|MPNST|Sorafenib 400 mg PO BID
706022|NCT00245102|O1|Outcome|Angiosarcoma|Sorafenib 400 mg PO BID
706023|NCT00245102|E6|Reported Event|Other Histology|Sorafenib 400 mg PO BID
706024|NCT00245102|E5|Reported Event|Fibrosarcoma|Sorafenib 400 mg PO BID
706025|NCT00245102|E4|Reported Event|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
706026|NCT00245102|E3|Reported Event|Leiomyosarcoma|Sorafenib 400 mg PO BID
706027|NCT00245102|E2|Reported Event|MPNST|Sorafenib 400 mg PO BID
706028|NCT00245102|E1|Reported Event|Angiosarcoma|Sorafenib 400 mg PO BID
706029|NCT00245063|B3|Baseline|Total|Total of all reporting groups
706030|NCT00245063|B2|Baseline|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706031|NCT00245063|B1|Baseline|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706032|NCT00245063|P2|Participant Flow|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706033|NCT00245063|P1|Participant Flow|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706034|NCT00245063|O2|Outcome|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706035|NCT00245063|O1|Outcome|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706036|NCT00245063|E2|Reported Event|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706037|NCT00245063|E1|Reported Event|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
706038|NCT00245050|B3|Baseline|Total|Total of all reporting groups
706039|NCT00245050|B2|Baseline|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
706040|NCT00245050|B1|Baseline|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
706041|NCT00245050|P2|Participant Flow|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
706042|NCT00245050|P1|Participant Flow|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
706043|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
706044|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
706045|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
706046|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
706047|NCT00245050|E2|Reported Event|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
706048|NCT00245050|E1|Reported Event|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
707767|NCT00236184|B3|Baseline|Total|Total of all reporting groups
706049|NCT00245037|B1|Baseline|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706050|NCT00245037|P1|Participant Flow|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706051|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706052|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706053|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706054|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706055|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706065|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
707774|NCT00236184|E2|Reported Event|Rabeprazole 10 mg|
706056|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706057|NCT00245037|O1|Outcome|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706058|NCT00245037|E1|Reported Event|Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)|"Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0~Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.~Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.~IV Busulfan is available and diluted and administered per package insert guidelines.~Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including"
706059|NCT00245011|B1|Baseline|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell collection. Samarium Sm153 Lexidronam Pentasodium is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of Samarium-153 is given, followed in 14 days by stem cell infusion.~Filgrastim: Filgrastim will be administered every day til count recovery Ifosfamide: Ifosfamide will be administered as part of Stem Cell transplant prep.~Peripheral blood stem cell transplantation: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium Sm 153 lexidronam pentasodium: First dose of Sm-EDTMP administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered 7 days later."
706060|NCT00245011|P1|Participant Flow|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.~Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion."
706061|NCT00245011|O1|Outcome|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. ^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of ^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.~filgrastim: Filgrastim is administered every day til count recovery.~ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.~peripheral blood stem cell harvesting: completed before administration of ^153Sm-EDTMP, collection of autologous hematopoietic stem cells.~radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of ^153Sm-EDTMP.~^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later."
706062|NCT00245011|E1|Reported Event|Samarium-153|"Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.~filgrastim: Filgrastim will be administered post post chemotherapy until target WBC count is achieved.~ifosfamide: Ifosfamide administered IV.~peripheral blood stem cell transplantation: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered~Sm-EDTMP (low dose): Sm-EDTMP (low dose) administered after autologous stem cell collection~sm-EDTMP (higher dose): Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation."
706063|NCT00244985|B1|Baseline|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
706064|NCT00244985|P1|Participant Flow|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
706316|NCT00244621|E3|Reported Event|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
706066|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
706067|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
706068|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
706069|NCT00244985|O1|Outcome|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
706070|NCT00244985|E1|Reported Event|Arm 1: Rituximab and Doxorubicin HCI Liposome|"Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3~rituximab: IV~pegylated liposomal doxorubicin hydrochloride: IV"
706071|NCT00244933|B1|Baseline|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
706072|NCT00244933|P1|Participant Flow|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
706073|NCT00244933|O1|Outcome|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
706074|NCT00244933|E1|Reported Event|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
706075|NCT00244881|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
706076|NCT00244881|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
706077|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
706078|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
706079|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
706080|NCT00244881|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
706081|NCT00244855|B3|Baseline|Total|Total of all reporting groups
706082|NCT00244855|B2|Baseline|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706083|NCT00244855|B1|Baseline|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706084|NCT00244855|P2|Participant Flow|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706085|NCT00244855|P1|Participant Flow|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706086|NCT00244855|O2|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706087|NCT00244855|O1|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706088|NCT00244855|O2|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706089|NCT00244855|O1|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706090|NCT00244855|E2|Reported Event|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706091|NCT00244855|E1|Reported Event|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
706092|NCT00244764|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
706093|NCT00244764|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
706094|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
706095|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
706096|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
706097|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
706098|NCT00244764|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
706099|NCT00244751|B4|Baseline|Total|Total of all reporting groups
706100|NCT00244751|B3|Baseline|GI262570 1.0 mg|Participants received GI262570 1.0 mg once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706101|NCT00244751|B2|Baseline|GI262570 0.5 mg|Participants received GI262570 0.5 mg. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706102|NCT00244751|B1|Baseline|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706103|NCT00244751|P3|Participant Flow|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706104|NCT00244751|P2|Participant Flow|GI262570 0.5 mg|Participants received GI262570 0.5 milligrams (mg) tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706105|NCT00244751|P1|Participant Flow|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706106|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706107|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706108|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706109|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706110|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706111|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706112|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706113|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706114|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706115|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706116|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706117|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706118|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706119|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started it receiving once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706120|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706121|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started it receiving once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706122|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706123|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706124|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706125|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706126|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706127|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706128|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706129|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706130|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706131|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started it receiving once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706132|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706133|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started it receiving once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706134|NCT00244751|O4|Outcome|GI262570 1.0 mg Once Daily|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706135|NCT00244751|O3|Outcome|GI262570 1.0 mg Twice Daily|Participants in this arm received GI262570 1.0 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706136|NCT00244751|O2|Outcome|GI262570 0.5 mg Once Daily|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706137|NCT00244751|O1|Outcome|GI262570 0.5 mg Twice Daily|Participants in this arm received GI262570 0.5 mg tablet twice daily as per protocol amendment 3. After implementation of protocol 4, they started receiving it once daily. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706138|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706139|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706140|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706141|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706142|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706143|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706144|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706145|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706317|NCT00244621|E2|Reported Event|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
706146|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706147|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706148|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706149|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706150|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706151|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706152|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706153|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706154|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706155|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706156|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706157|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706158|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706159|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706160|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706161|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706162|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706163|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706164|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706165|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706166|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706167|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706168|NCT00244751|O3|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706169|NCT00244751|O2|Outcome|GI262570 0.5mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706170|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706171|NCT00244751|O3|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706172|NCT00244751|O2|Outcome|GI262570 0.5mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706173|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706174|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706175|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706176|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706177|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706178|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706179|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706180|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706181|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706182|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706183|NCT00244751|O3|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706184|NCT00244751|O2|Outcome|GI262570 0.5mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706185|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706186|NCT00244751|O3|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706187|NCT00244751|O2|Outcome|GI262570 0.5mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706188|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706189|NCT00244751|O3|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706190|NCT00244751|O2|Outcome|GI262570 0.5mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706191|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706192|NCT00244751|O3|Outcome|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706193|NCT00244751|O2|Outcome|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706194|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706195|NCT00244751|O3|Outcome|GI262570 1.0mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706196|NCT00244751|O2|Outcome|GI262570 0.5mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706197|NCT00244751|O1|Outcome|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706198|NCT00244751|E3|Reported Event|GI262570 1.0 mg|Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706199|NCT00244751|E2|Reported Event|GI262570 0.5 mg|Participants received GI262570 0.5 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706200|NCT00244751|E1|Reported Event|Placebo|Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
706201|NCT00244725|B5|Baseline|Total|Total of all reporting groups
706202|NCT00244725|B4|Baseline|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706203|NCT00244725|B3|Baseline|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706204|NCT00244725|B2|Baseline|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706793|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706205|NCT00244725|B1|Baseline|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706206|NCT00244725|P4|Participant Flow|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target International Normalized Ratio (INR) of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706207|NCT00244725|P3|Participant Flow|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706208|NCT00244725|P2|Participant Flow|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706209|NCT00244725|P1|Participant Flow|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil modified release (MR) 250 mg tablet at every 12 hours interval (Q12h)for the duration of 10 ± 2 days of double-blind treatment period.
706210|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706211|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706212|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706213|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706214|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706215|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706216|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706217|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706218|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706219|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706220|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706221|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706222|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706223|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706224|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706225|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706226|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706227|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706228|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706229|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706230|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706231|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706232|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706233|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706234|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706235|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706236|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706237|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706238|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706239|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706240|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706241|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706242|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706243|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706244|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706245|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706246|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706247|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706248|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706249|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706250|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706251|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706252|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706253|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706254|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706255|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706256|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706257|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706258|NCT00244725|E4|Reported Event|WARFARIN INR 2.0 TO 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
706259|NCT00244725|E3|Reported Event|ODIPARCIL MR 500 MG TABLET|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706260|NCT00244725|E2|Reported Event|ODIPARCIL MR 375 MG TABLET|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706261|NCT00244725|E1|Reported Event|ODIPARCIL MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
706262|NCT00244712|B3|Baseline|Total|Total of all reporting groups
706263|NCT00244712|B2|Baseline|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706264|NCT00244712|B1|Baseline|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706265|NCT00244712|P2|Participant Flow|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706266|NCT00244712|P1|Participant Flow|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706267|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706268|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706269|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706270|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706271|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706272|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706273|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706274|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706275|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706276|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706277|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706278|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706279|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706280|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706281|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706282|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706283|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706284|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706285|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706286|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706287|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706288|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706289|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706290|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706291|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706292|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706293|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706294|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706295|NCT00244712|E2|Reported Event|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
706296|NCT00244712|E1|Reported Event|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
706297|NCT00244621|B4|Baseline|Total|Total of all reporting groups
706298|NCT00244621|B3|Baseline|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
706299|NCT00244621|B2|Baseline|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
706300|NCT00244621|B1|Baseline|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
706301|NCT00244621|P3|Participant Flow|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
706302|NCT00244621|P2|Participant Flow|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
706303|NCT00244621|P1|Participant Flow|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
706304|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
706305|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
706306|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
706307|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
706308|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
706309|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
706310|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
706311|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
706312|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
706313|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
706314|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
706315|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
706318|NCT00244621|E1|Reported Event|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
706319|NCT00244374|B1|Baseline|All Participants|Participants in pre-randomization cross-sectional study
706320|NCT00244374|P5|Participant Flow|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
706321|NCT00244374|P4|Participant Flow|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
706322|NCT00244374|P3|Participant Flow|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
706323|NCT00244374|P2|Participant Flow|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
706324|NCT00244374|P1|Participant Flow|Cross-sectional/Screening|Cross-sectional screening to determine eligibility for vaccine adherence trial
706325|NCT00244374|O1|Outcome|Screening Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
706326|NCT00244374|O1|Outcome|Cross-sectional Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
706327|NCT00244374|O2|Outcome|Did Not Travel in the Prior 3 Months|"Participants who answered no when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, or whose last 3 travel destinations within 30 miles of San Francisco"
706328|NCT00244374|O1|Outcome|Traveled in the Prior 3 Months|"Participants who answered yes when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, and whose last 3 travel destinations were at least 30 miles from San Francisco"
706329|NCT00244374|O2|Outcome|Anti-HCV Negative|Participants tested negative for Hepatitis C Virus (HCV) antibody
706330|NCT00244374|O1|Outcome|Anti-HCV Positive|Participants tested positive for Hepatitis C Virus (HCV) antibody
706331|NCT00244374|O4|Outcome|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
706332|NCT00244374|O3|Outcome|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
706333|NCT00244374|O2|Outcome|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
706334|NCT00244374|O1|Outcome|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
706335|NCT00244374|E4|Reported Event|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
706336|NCT00244374|E3|Reported Event|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
706337|NCT00244374|E2|Reported Event|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
706338|NCT00244374|E1|Reported Event|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
706339|NCT00244140|B3|Baseline|Total|Total of all reporting groups
706340|NCT00244140|B2|Baseline|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
706341|NCT00244140|B1|Baseline|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
706342|NCT00244140|P2|Participant Flow|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
706343|NCT00244140|P1|Participant Flow|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
706344|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
706345|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
706346|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
706347|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
706348|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
706349|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
706350|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
706351|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
706352|NCT00244140|E2|Reported Event|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
706353|NCT00244140|E1|Reported Event|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
706354|NCT00244101|B4|Baseline|Total|Total of all reporting groups
706355|NCT00244101|B3|Baseline|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
706356|NCT00244101|B2|Baseline|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
706794|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706357|NCT00244101|B1|Baseline|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
706358|NCT00244101|P3|Participant Flow|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
706359|NCT00244101|P2|Participant Flow|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
706360|NCT00244101|P1|Participant Flow|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
706361|NCT00244101|O3|Outcome|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
706362|NCT00244101|O2|Outcome|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
706363|NCT00244101|O1|Outcome|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
706364|NCT00244101|E3|Reported Event|NCPAP|initial management with bubble nCPAP and selective surfactant treatment
706365|NCT00244101|E2|Reported Event|Surfactant Extubated to nCPAP|prophylactic surfactant with rapid extubation to bubble nCPAP
706366|NCT00244101|E1|Reported Event|Prophylactic Surfactant|Prophylactic surfactant followed by mechanical ventilation
706367|NCT00244010|B3|Baseline|Total|Total of all reporting groups
706368|NCT00244010|B2|Baseline|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
706369|NCT00244010|B1|Baseline|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
706370|NCT00244010|P2|Participant Flow|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
706371|NCT00244010|P1|Participant Flow|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
706372|NCT00244010|O2|Outcome|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
706373|NCT00244010|O1|Outcome|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
706374|NCT00244010|E2|Reported Event|Donor|Donors were not assessed for adverse events.
706375|NCT00244010|E1|Reported Event|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
706376|NCT00243932|B4|Baseline|Total|Total of all reporting groups
706377|NCT00243932|B3|Baseline|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
706378|NCT00243932|B2|Baseline|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
706379|NCT00243932|B1|Baseline|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
706380|NCT00243932|P3|Participant Flow|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
706381|NCT00243932|P2|Participant Flow|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
706382|NCT00243932|P1|Participant Flow|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
706383|NCT00243932|O3|Outcome|1,800 mg CoQ10|35 patients. Mean and SD are presented but this group was not included in the efficacy analysis because the 1,800 mg dose was discontinued after stage 1.
706384|NCT00243932|O2|Outcome|Placebo|40 new subjects plus 35 subjects from stage 1 receiving placebo - total 75.
706385|NCT00243932|O1|Outcome|2700mg CoQ10|"40 new subjects and 35 subjects from stage 1 all taking 2,700mg CoQ10 - total 75.~Stage 1 - 35 participants per group compared CoQ10 doses of 1,800mg and 2,700 mg/day and placebo."
706386|NCT00243932|E3|Reported Event|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
706387|NCT00243932|E2|Reported Event|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
706388|NCT00243932|E1|Reported Event|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
706389|NCT00243919|B4|Baseline|Total|Total of all reporting groups
706390|NCT00243919|B3|Baseline|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706391|NCT00243919|B2|Baseline|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706392|NCT00243919|B1|Baseline|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706393|NCT00243919|P3|Participant Flow|Home Exercise Program|Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706394|NCT00243919|P2|Participant Flow|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706395|NCT00243919|P1|Participant Flow|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706396|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706397|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706398|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706399|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706400|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706401|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706402|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706403|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706404|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706405|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706406|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706407|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706408|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706409|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706410|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706411|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706412|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706413|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706414|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706415|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706416|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706417|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706418|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706419|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706420|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706421|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706422|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706423|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706424|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706425|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706426|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706427|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706428|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706429|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706430|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706431|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706432|NCT00243919|E3|Reported Event|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
706433|NCT00243919|E2|Reported Event|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
706434|NCT00243919|E1|Reported Event|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
706435|NCT00243659|B3|Baseline|Total|Total of all reporting groups
706436|NCT00243659|B2|Baseline|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
706437|NCT00243659|B1|Baseline|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
706438|NCT00243659|P2|Participant Flow|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
706439|NCT00243659|P1|Participant Flow|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
706440|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
706441|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
706442|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
706443|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
706444|NCT00243659|E2|Reported Event|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
706445|NCT00243659|E1|Reported Event|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
706446|NCT00243503|B1|Baseline|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706447|NCT00243503|P1|Participant Flow|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706448|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706795|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706449|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706450|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706451|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706452|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706453|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706454|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706455|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706456|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706457|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706458|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles
706459|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706460|NCT00243503|E1|Reported Event|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
706461|NCT00243412|B3|Baseline|Total|Total of all reporting groups
706462|NCT00243412|B2|Baseline|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706463|NCT00243412|B1|Baseline|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706464|NCT00243412|P2|Participant Flow|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion, For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706465|NCT00243412|P1|Participant Flow|Arm A: 500 mg Rituximab|Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706466|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706467|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706616|NCT00243022|B2|Baseline|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
707775|NCT00236184|E1|Reported Event|Placebo|
706468|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706469|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706470|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706471|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706472|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706473|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706474|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706475|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706476|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706477|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706478|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706479|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706480|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706481|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706482|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706796|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706797|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706483|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706484|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706485|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706486|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706487|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706488|NCT00243412|E2|Reported Event|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706489|NCT00243412|E1|Reported Event|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
706490|NCT00243386|B1|Baseline|All Study Participants|Participants first underwent an open-label evaluation of rAHF-PFM PK. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
706491|NCT00243386|P3|Participant Flow|Standard Prophylaxis|The standard prophylactic regimen was dosed at 20 to 40 IU/kg of rAHF-PFM every 48 ±6 hours
706492|NCT00243386|P2|Participant Flow|PK-Driven Prophylaxis|The PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg of rAHF-PFM every 72 ±6 hours
706493|NCT00243386|P1|Participant Flow|All Study Participants|Participants first underwent an open-label pharmacokinetic (PK) evaluation of rAHF-PFM. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
706494|NCT00243386|O4|Outcome|Any Prophylaxis|Either Standard or PK-driven Prophylaxis
706495|NCT00243386|O3|Outcome|PK-driven Prophylaxis|Dosed at 20 to 80 IU/kg every 72 ±6 hours for 12 months (Part 2)
706496|NCT00243386|O2|Outcome|Standard Prophylaxis|Dosed at 20 to 40 IU/kg every 48 ±6 hours for 12 months (Part 2)
706497|NCT00243386|O1|Outcome|On-Demand Regimen|After the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1)
706498|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
706499|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
706500|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
706501|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
706502|NCT00243386|O3|Outcome|On-Demand to Any Prophylaxis Treatment|
706503|NCT00243386|O2|Outcome|On-Demand to PK-Driven Prophylaxis|
706504|NCT00243386|O1|Outcome|On-Demand to Standard Prophylaxis|
706505|NCT00243386|O4|Outcome|Any Prophylaxis Treatment|Any Prophylaxis Treatment (either Standard Prophylaxis or PK-Driven Prophylaxis) Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator PK-Driven Prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
706506|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
706507|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
706617|NCT00243022|B1|Baseline|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706508|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
706509|NCT00243386|O1|Outcome|Assessed Before Treatment|
706510|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
706511|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
706512|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
706513|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to investigational product (IP)
706514|NCT00243386|O4|Outcome|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
706515|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
706516|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
706517|NCT00243386|O1|Outcome|On-Demand|
706518|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
706519|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
706520|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
706521|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
706522|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
706523|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to Investigational Product (IP)
706524|NCT00243386|O2|Outcome|<14 Years of Age|
706525|NCT00243386|O1|Outcome|≥14 Years of Age|
706526|NCT00243386|O2|Outcome|<14 Years of Age|
706527|NCT00243386|O1|Outcome|≥14 Years of Age|
706528|NCT00243386|O2|Outcome|<14 Years of Age|
706529|NCT00243386|O1|Outcome|≥14 Years of Age|
706530|NCT00243386|O2|Outcome|<14 Years of Age|
706531|NCT00243386|O1|Outcome|≥14 Years of Age|
706532|NCT00243386|O2|Outcome|<14 Years of Age|
706533|NCT00243386|O1|Outcome|≥14 Years of Age|
706534|NCT00243386|O2|Outcome|<14 Years of Age|
706535|NCT00243386|O1|Outcome|≥14 Years of Age|
706536|NCT00243386|O2|Outcome|<14 Years of Age|
706537|NCT00243386|O1|Outcome|≥14 Years of Age|
706538|NCT00243386|O2|Outcome|<14 Years of Age|
706539|NCT00243386|O1|Outcome|≥14 Years of Age|
706540|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
706541|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
706542|NCT00243386|O1|Outcome|On-Demand Regimen|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
706543|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
706544|NCT00243386|O2|Outcome|Standard Prophylaxis Treatment|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
706545|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
706546|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
706547|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
706548|NCT00243386|O1|Outcome|On-Demand Versus Any Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)~Prophylaxis:~Standard prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator~PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
706549|NCT00243386|O1|Outcome|On-Demand Versus PK-Driven Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)~PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
706550|NCT00243386|O1|Outcome|On-Demand Versus Standard Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, Gastrointestinal (GI), and intracranial (60-100 IU/kg every 8-12 hours)~Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator"
706551|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
706552|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
706553|NCT00243386|E4|Reported Event|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
706554|NCT00243386|E3|Reported Event|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg (every 72 ±6 hours) exact regimen to be determined by the sponsor
706555|NCT00243386|E2|Reported Event|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg (every 48 ±6 hours), exact regimen to be determined by the investigator
706556|NCT00243386|E1|Reported Event|On-Demand|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
706557|NCT00243347|B1|Baseline|Cediranib 30 mg|Cediranib 30mg/Day
706558|NCT00243347|P1|Participant Flow|Cediranib 30 mg|Cediranib 30mg/Day
706559|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
706560|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
706561|NCT00243347|E1|Reported Event|Cediranib 30 mg|Cediranib 30mg/Day
706562|NCT00243269|B5|Baseline|Total|Total of all reporting groups
706563|NCT00243269|B4|Baseline|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
706564|NCT00243269|B3|Baseline|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
706565|NCT00243269|B2|Baseline|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
706566|NCT00243269|B1|Baseline|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
706567|NCT00243269|P4|Participant Flow|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
706568|NCT00243269|P3|Participant Flow|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
706569|NCT00243269|P2|Participant Flow|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
706798|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706570|NCT00243269|P1|Participant Flow|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
706571|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
706572|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
706573|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
706574|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
706575|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
706576|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
706577|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
706578|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
706579|NCT00243269|E4|Reported Event|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
706618|NCT00243022|P2|Participant Flow|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/day given orally"
706799|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706800|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706801|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706580|NCT00243269|E3|Reported Event|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
706581|NCT00243269|E2|Reported Event|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
706582|NCT00243269|E1|Reported Event|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
706583|NCT00243243|B3|Baseline|Total|Total of all reporting groups
706584|NCT00243243|B2|Baseline|Control|
706585|NCT00243243|B1|Baseline|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
706586|NCT00243243|P2|Participant Flow|Control- Placebo|Intravenous infusion of a placebo
706587|NCT00243243|P1|Participant Flow|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
706588|NCT00243243|O2|Outcome|Control- Placebo|Intravenous infusion of a placebo
706589|NCT00243243|O1|Outcome|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
706590|NCT00243243|E2|Reported Event|Control|
706591|NCT00243243|E1|Reported Event|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
706592|NCT00243191|B1|Baseline|Imatinib|
706593|NCT00243191|P1|Participant Flow|Imatinib|
706594|NCT00243191|O1|Outcome|Imatinib|
706595|NCT00243191|E1|Reported Event|Imatinib|
706596|NCT00243074|B1|Baseline|AZD2171|
706597|NCT00243074|P1|Participant Flow|AZD2171 (Cediranib Maleate)|
706598|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
706599|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
706600|NCT00243074|O1|Outcome|AZD2171|
706601|NCT00243074|O1|Outcome|AZD2171|
706602|NCT00243074|O1|Outcome|AZD2171|
706603|NCT00243074|O1|Outcome|AZD2171|
706604|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
706605|NCT00243074|E1|Reported Event|AZD2171|
706606|NCT00243061|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
706607|NCT00243061|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
706608|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
706609|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
706610|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
706611|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
706612|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
706613|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
706614|NCT00243061|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
706615|NCT00243022|B3|Baseline|Total|Total of all reporting groups
706694|NCT00242684|P1|Participant Flow|Transitional Care Unit Veterans|older patients admitted to a TCU unit
706619|NCT00243022|P1|Participant Flow|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706620|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706621|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706622|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706623|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706624|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706625|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706626|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706627|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706628|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706629|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706630|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706631|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706632|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706633|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706634|NCT00243022|E2|Reported Event|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
706635|NCT00243022|E1|Reported Event|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
706636|NCT00242710|B5|Baseline|Total|Total of all reporting groups
706637|NCT00242710|B4|Baseline|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706638|NCT00242710|B3|Baseline|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706639|NCT00242710|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706640|NCT00242710|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706641|NCT00242710|P4|Participant Flow|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706695|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
706696|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
706642|NCT00242710|P3|Participant Flow|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706643|NCT00242710|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706644|NCT00242710|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706645|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706646|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706647|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706648|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706649|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706650|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706651|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706652|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706653|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706654|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706655|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706656|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706657|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706658|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706697|NCT00242684|E1|Reported Event|Transitional Care Unit Veterans|older patients admitted to a TCU unit
706698|NCT00242658|B3|Baseline|Total|Total of all reporting groups
706659|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706660|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706661|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706662|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706663|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706664|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706665|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706666|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706667|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706668|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706669|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706670|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706671|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706672|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706673|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706674|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706675|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706699|NCT00242658|B2|Baseline|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
706676|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706677|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706678|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706679|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706680|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706681|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706682|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706683|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706684|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706685|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706686|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706687|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706688|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706689|NCT00242710|E4|Reported Event|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706690|NCT00242710|E3|Reported Event|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706691|NCT00242710|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
706692|NCT00242710|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
706693|NCT00242684|B1|Baseline|Transitional Care Unit Veterans|older patients admitted to a TCU unit
707776|NCT00236080|B6|Baseline|Total|Total of all reporting groups
706700|NCT00242658|B1|Baseline|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
706701|NCT00242658|P2|Participant Flow|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
706702|NCT00242658|P1|Participant Flow|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
706703|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
706704|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
706705|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
706706|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
706707|NCT00242658|E2|Reported Event|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
706708|NCT00242658|E1|Reported Event|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
706709|NCT00242632|B3|Baseline|Total|Total of all reporting groups
706710|NCT00242632|B2|Baseline|apoE-e4+|Subjects with the apoE-e4 allele
706711|NCT00242632|B1|Baseline|apoE-e4-|Subjects without the apoE-e4 allele
706712|NCT00242632|P2|Participant Flow|apoE-e4+|Subjects with the apoE-e4 allele
706713|NCT00242632|P1|Participant Flow|apoE-e4-|Subjects without the apoE-e4 allele
706714|NCT00242632|O1|Outcome|T1-T2|This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
706715|NCT00242632|O1|Outcome|T1-T2|This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
706716|NCT00242632|E2|Reported Event|ApoE-e4-|This includes the 11 subjects who were non-carriers of the ApoE-e4 allele.
706717|NCT00242632|E1|Reported Event|ApoE-e4+|This includes the 11 subjects who were carriers of the ApoE-e4 allele.
706718|NCT00242619|B3|Baseline|Total|Total of all reporting groups
706719|NCT00242619|B2|Baseline|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
706720|NCT00242619|B1|Baseline|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
706721|NCT00242619|P2|Participant Flow|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
706722|NCT00242619|P1|Participant Flow|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
706723|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
706724|NCT00242619|O1|Outcome|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
706725|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out of the study.
706726|NCT00242619|O1|Outcome|Completers|Subjects who completed the study.
706727|NCT00242619|E2|Reported Event|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
706728|NCT00242619|E1|Reported Event|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
706729|NCT00242580|B4|Baseline|Total|Total of all reporting groups
706730|NCT00242580|B3|Baseline|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706731|NCT00242580|B2|Baseline|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706783|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706784|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706785|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706786|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
709317|NCT00227903|O1|Outcome|Brief Advice|Advice and education
706732|NCT00242580|B1|Baseline|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706733|NCT00242580|P3|Participant Flow|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706734|NCT00242580|P2|Participant Flow|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706735|NCT00242580|P1|Participant Flow|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706736|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706737|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706738|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706739|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706740|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706741|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706742|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706787|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706788|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706789|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706743|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706744|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706745|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706746|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706747|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706748|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706749|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706750|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706751|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706752|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706753|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706790|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706791|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
706792|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706754|NCT00242580|E3|Reported Event|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
706755|NCT00242580|E2|Reported Event|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706756|NCT00242580|E1|Reported Event|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
706757|NCT00242567|B3|Baseline|Total|Total of all reporting groups
706758|NCT00242567|B2|Baseline|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
706759|NCT00242567|B1|Baseline|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
706760|NCT00242567|P2|Participant Flow|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
706761|NCT00242567|P1|Participant Flow|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
706762|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
706763|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
706764|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
706765|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
706766|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
706767|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
706768|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
706769|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
706770|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
706771|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
706772|NCT00242567|E4|Reported Event|Delayed Group (Zometa)|Delayed Group (Zometa)
706773|NCT00242567|E3|Reported Event|Delayed Group (No Zometa)|Delayed Group (No Zometa)
706774|NCT00242567|E2|Reported Event|Delayed Group (Overall)|Delayed Group (Overall)
706775|NCT00242567|E1|Reported Event|Early Group|Early Group
706776|NCT00242502|B1|Baseline|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
706777|NCT00242502|P1|Participant Flow|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
706778|NCT00242502|O1|Outcome|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
706779|NCT00242502|E1|Reported Event|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
706780|NCT00242385|B1|Baseline|Subjects With Severe Congenital α1-PI Deficiency|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
706781|NCT00242385|P2|Participant Flow|ARALAST Then ARALAST Fr. IV-1|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
706782|NCT00242385|P1|Participant Flow|ARALAST Fr. IV-1 Then Aralast|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
706802|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
706803|NCT00242385|E2|Reported Event|ARALAST|Subjects received a single dose of ARALAST 60 mg/kg at 0.2 mL/kg/min
706804|NCT00242385|E1|Reported Event|ARALAST Fr. IV-1|Subjects received a single dose of ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min
706805|NCT00242216|B3|Baseline|Total|Total of all reporting groups
706806|NCT00242216|B2|Baseline|Fosamprenavir|
706807|NCT00242216|B1|Baseline|Atazanavir|
706808|NCT00242216|P2|Participant Flow|Fosamprenavir|Fosamprenavir/ritonavir (1400mg/100mg) once daily
706809|NCT00242216|P1|Participant Flow|Atazanavir|Atazanavir/ritonavir (300mg/100mg) once daily
706810|NCT00242216|O2|Outcome|Fosamprenavir|
706811|NCT00242216|O1|Outcome|Atazanavir|
706812|NCT00242216|O2|Outcome|Fosamprenavir|
706813|NCT00242216|O1|Outcome|Atazanavir|
706814|NCT00242216|E2|Reported Event|Fosamprenavir|
706815|NCT00242216|E1|Reported Event|Atazanavir|
706816|NCT00241969|B3|Baseline|Total|Total of all reporting groups
706817|NCT00241969|B2|Baseline|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
706818|NCT00241969|B1|Baseline|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
706819|NCT00241969|P2|Participant Flow|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
706820|NCT00241969|P1|Participant Flow|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
706821|NCT00241969|O2|Outcome|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
706822|NCT00241969|O1|Outcome|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
706823|NCT00241969|O2|Outcome|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
706824|NCT00241969|O1|Outcome|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
706825|NCT00241969|O2|Outcome|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
706826|NCT00241969|O1|Outcome|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
706827|NCT00241969|E2|Reported Event|Education and Attention Control Treatment|"Education and Attention Control Treatment~Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers."
706828|NCT00241969|E1|Reported Event|Behavioral and Nutrition Treatment|"Behavioral and Nutrition Treatment~Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills."
706829|NCT00241904|B3|Baseline|Total|Total of all reporting groups
706830|NCT00241904|B2|Baseline|Less Intensive Intervention|LI Arm: Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.
706831|NCT00241904|B1|Baseline|Comprehensive Intervention|CI intervention will receive Behavioral: Lifestyle Changes, Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercises, as well as pharmacologic agents
706832|NCT00241904|P2|Participant Flow|Less Intensive Intervention (Usual Care) Group|Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.
706833|NCT00241904|P1|Participant Flow|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms.Participants will receive a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians.~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706834|NCT00241904|O2|Outcome|Less Intensive Intervention Group|"Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706876|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
707278|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
706835|NCT00241904|O1|Outcome|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706836|NCT00241904|O2|Outcome|Less Intensive Intervention Group|"Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706837|NCT00241904|O1|Outcome|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors:Oral medications, received 1-2 times per day"
706838|NCT00241904|O2|Outcome|Less Intensive Intervention Group|"Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706839|NCT00241904|O1|Outcome|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706840|NCT00241904|O2|Outcome|Less Intensive Intervention Group|"Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians.~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706841|NCT00241904|O1|Outcome|Comprehensive Intervention Group|"Participants will receive a Comprehensive Intervention (CI) delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes in diet, exercise and medication adherence as well as the prescription and titration of medications prescribed according to study algorithms for antiplatelet agents, beta blockers, ace inhibitors..~Lifestyle Changes: Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise~Antiplatelet Agents: Aspirin 81 mg q day~Beta Blocker: Oral medication~ACE Inhibitors: Oral medications, received 1-2 times per day"
706842|NCT00241904|E2|Reported Event|Less Intensive Intervention|
706843|NCT00241904|E1|Reported Event|Comprehensive Intervention Group|
706844|NCT00241839|B3|Baseline|Total|Total of all reporting groups
706845|NCT00241839|B2|Baseline|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706846|NCT00241839|B1|Baseline|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706847|NCT00241839|P2|Participant Flow|B(Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706848|NCT00241839|P1|Participant Flow|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706849|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706877|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706878|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706850|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706851|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706852|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706853|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706854|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706855|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706856|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706857|NCT00241839|E2|Reported Event|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706858|NCT00241839|E1|Reported Event|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
706859|NCT00241644|B5|Baseline|Total|Total of all reporting groups
706860|NCT00241644|B4|Baseline|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
706861|NCT00241644|B3|Baseline|Placebo Group|Subjects received 3 doses of placebo.
706862|NCT00241644|B2|Baseline|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706863|NCT00241644|B1|Baseline|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706864|NCT00241644|P4|Participant Flow|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
706865|NCT00241644|P3|Participant Flow|Placebo Group|Subjects received 3 doses of placebo.
706866|NCT00241644|P2|Participant Flow|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706867|NCT00241644|P1|Participant Flow|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706868|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706869|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706870|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706871|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706872|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706873|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706874|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706875|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706879|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706880|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706881|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706882|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706883|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706884|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706885|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706886|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706887|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706888|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706889|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706890|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706891|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706892|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706893|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706894|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706895|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706896|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706897|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706898|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706899|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706900|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706901|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706902|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706903|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706904|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706905|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706906|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706907|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706908|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706909|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706910|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706911|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706912|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706913|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706914|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706915|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706916|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706917|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706918|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706919|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706920|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706921|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706922|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706923|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706924|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706925|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706926|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706927|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706928|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
707023|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
706929|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706930|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706931|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706932|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706933|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706934|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706935|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706936|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706937|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706938|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706939|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706940|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
706941|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706942|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706943|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706944|NCT00241644|E4|Reported Event|Placebo Group|Subjects received 3 doses of placebo.
706945|NCT00241644|E3|Reported Event|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
706946|NCT00241644|E2|Reported Event|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
706947|NCT00241644|E1|Reported Event|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
706948|NCT00241358|B4|Baseline|Total|Total of all reporting groups
706949|NCT00241358|B3|Baseline|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706950|NCT00241358|B2|Baseline|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706951|NCT00241358|B1|Baseline|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706952|NCT00241358|P3|Participant Flow|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706953|NCT00241358|P2|Participant Flow|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706954|NCT00241358|P1|Participant Flow|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706955|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706956|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706957|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706958|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706959|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706960|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706961|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706962|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706963|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
707058|NCT00240526|B5|Baseline|Total|Total of all reporting groups
706964|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706965|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706966|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706967|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706968|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706969|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706970|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706971|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706972|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706973|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706974|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706975|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706976|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706977|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706978|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706979|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706980|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
706981|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
706982|NCT00241358|E2|Reported Event|Recipients|Stem Cell Transplantation Day 0
706983|NCT00241358|E1|Reported Event|Donors|AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3
706984|NCT00241280|B3|Baseline|Total|Total of all reporting groups
706985|NCT00241280|B2|Baseline|Test: Galyfilcon A|Subjects that were randomized to receive the Test lens galyfilcon A
706986|NCT00241280|B1|Baseline|Control: Etafilcon A|Subjects that were randomized to receive the Control lens etafilcon A
706987|NCT00241280|P2|Participant Flow|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
706988|NCT00241280|P1|Participant Flow|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
706989|NCT00241280|O2|Outcome|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
706990|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
706991|NCT00241280|O2|Outcome|Test: Galyfilcon A|"Subjects that were randomly assigned to wear the Test lens.~It was reported that for one subject eye, that the contact lens was dirty during the visual acuity testing."
706992|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
706993|NCT00241280|E2|Reported Event|Test: Galyfilcon A|Subjects that were randomly assigned to wear Test lens.
706994|NCT00241280|E1|Reported Event|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
706995|NCT00241176|B1|Baseline|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
707059|NCT00240526|B4|Baseline|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707060|NCT00240526|B3|Baseline|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
706996|NCT00241176|P1|Participant Flow|Aripiprazole|Subjects received initial dose based on body weight at Visit 2: Subjects between 25-50 kg were started on 1.25 mg/day, Subjects between 50-70 kg were started on 2.5 mg/day, Subjects greater than 70 kg were started on 5 mg/day. Dosage was titrated at Visit 3, 5, 6, or 7 based on YGTSS and CGI-TS ratings at the discretion of the investigator. Subjects who showed evidence of response (reduction in CGI-TS by 1-2 points)remained on the same dose. Subjects who did not show evidence of response could be increased: Subjects between 25-50 kg were could be increased 1.25 mg/day at each titration visit, Subjects between 50-70 kg could be increased 2.5 mg/day at each titration visit, and Subjects greater than 70 kg could be increased 5 mg/day at each titration visit.
706997|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
706998|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
706999|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
707000|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
707001|NCT00241176|E1|Reported Event|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
707002|NCT00240994|B1|Baseline|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
707003|NCT00240994|P1|Participant Flow|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
707004|NCT00240994|O1|Outcome|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
707005|NCT00240994|E1|Reported Event|Alemtuzumab (Campath)|In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
707006|NCT00240981|B3|Baseline|Total|Total of all reporting groups
707007|NCT00240981|B2|Baseline|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707008|NCT00240981|B1|Baseline|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707009|NCT00240981|P2|Participant Flow|Placebo|
707010|NCT00240981|P1|Participant Flow|Treatment|
707011|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707012|NCT00240981|O1|Outcome|Testosterone|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707013|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707014|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707015|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707016|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707017|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707018|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707019|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707020|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707021|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707022|NCT00240981|O1|Outcome|Testosterone|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707024|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707025|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707026|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707027|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707028|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707029|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707030|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707031|NCT00240981|E2|Reported Event|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
707032|NCT00240981|E1|Reported Event|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
707033|NCT00240539|B5|Baseline|Total|Total of all reporting groups
707034|NCT00240539|B4|Baseline|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
707035|NCT00240539|B3|Baseline|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
707036|NCT00240539|B2|Baseline|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
707037|NCT00240539|B1|Baseline|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
707038|NCT00240539|P4|Participant Flow|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
707039|NCT00240539|P3|Participant Flow|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
707040|NCT00240539|P2|Participant Flow|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
707041|NCT00240539|P1|Participant Flow|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
707042|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
707043|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
707044|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
707045|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
707046|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
707047|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
707048|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
707049|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
707050|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
707051|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
707052|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
707053|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
707054|NCT00240539|E4|Reported Event|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
707055|NCT00240539|E3|Reported Event|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
707056|NCT00240539|E2|Reported Event|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
707057|NCT00240539|E1|Reported Event|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
707061|NCT00240526|B2|Baseline|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707062|NCT00240526|B1|Baseline|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707063|NCT00240526|P4|Participant Flow|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707064|NCT00240526|P3|Participant Flow|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707065|NCT00240526|P2|Participant Flow|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707066|NCT00240526|P1|Participant Flow|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707067|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707068|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707069|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707070|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707071|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707072|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707073|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707074|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707075|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707076|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707077|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707078|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707079|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707080|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707081|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707082|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707083|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707084|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707085|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707086|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707087|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707088|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707089|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707090|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707091|NCT00240526|E4|Reported Event|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
707092|NCT00240526|E3|Reported Event|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
707093|NCT00240526|E2|Reported Event|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707094|NCT00240526|E1|Reported Event|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
707095|NCT00240500|B7|Baseline|Total|Total of all reporting groups
707096|NCT00240500|B6|Baseline|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707097|NCT00240500|B5|Baseline|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707098|NCT00240500|B4|Baseline|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
709857|NCT00224029|B1|Baseline|Oxybutynin Transdermal System|
707099|NCT00240500|B3|Baseline|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707100|NCT00240500|B2|Baseline|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707101|NCT00240500|B1|Baseline|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707102|NCT00240500|P6|Participant Flow|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707103|NCT00240500|P5|Participant Flow|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707104|NCT00240500|P4|Participant Flow|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707105|NCT00240500|P3|Participant Flow|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707106|NCT00240500|P2|Participant Flow|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707107|NCT00240500|P1|Participant Flow|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707108|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707109|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707110|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707111|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707112|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707113|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707114|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707115|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707116|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707117|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707118|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707119|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707120|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707121|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707122|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707123|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707124|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
707125|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
707126|NCT00240487|B3|Baseline|Total|Total of all reporting groups
707127|NCT00240487|B2|Baseline|Delayed Nitric Oxide|Subjects received no intervention (no nitric oxide) for the first 4 hours of study participation. After which, they received 10 ppm nitric oxide for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
707188|NCT00240097|E2|Reported Event|Regimen B First Cycle|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
709858|NCT00224029|P1|Participant Flow|Oxybutynin Transdermal System|
707128|NCT00240487|B1|Baseline|Nitric Oxide First|Subjects received 10 ppm nitric oxide for the first 4 hours of study participation After which, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
707129|NCT00240487|P2|Participant Flow|Delayed Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
707130|NCT00240487|P1|Participant Flow|Nitric Oxide First|Subjects who were randomized to receive Nitric Oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the initial 8 hours of study participation, subjects remained on whichever intervention (no intervention versus 10 ppm nitric oxide) they responded best to.
707131|NCT00240487|O2|Outcome|Delayed Nitric Oxide Treatment|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
707132|NCT00240487|O1|Outcome|Immediate Nitric Oxide Treatment|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received treatment standard clinical care. Blood gases were monitored once an hour for 4 hours.
707133|NCT00240487|E2|Reported Event|Delayed Treatment With Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
707134|NCT00240487|E1|Reported Event|Immediate Treatment With Nitric Oxide|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours.
707135|NCT00240331|B3|Baseline|Total|Total of all reporting groups
707136|NCT00240331|B2|Baseline|Placebo|Matching placebo
707137|NCT00240331|B1|Baseline|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707138|NCT00240331|P2|Participant Flow|Placebo|Matching placebo
707139|NCT00240331|P1|Participant Flow|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707140|NCT00240331|O2|Outcome|Placebo|Matching placebo
707141|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707142|NCT00240331|O2|Outcome|Placebo|Matching placebo
707143|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707144|NCT00240331|O2|Outcome|Placebo|Matching placebo
707145|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707146|NCT00240331|O2|Outcome|Placebo|Matching placebo
707147|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707148|NCT00240331|O2|Outcome|Placebo|Matching placebo
707149|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707150|NCT00240331|O2|Outcome|Placebo|Matching placebo
707151|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707152|NCT00240331|O2|Outcome|Placebo|Matching placebo
707153|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707154|NCT00240331|E2|Reported Event|Placebo|Matching placebo
707155|NCT00240331|E1|Reported Event|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
707156|NCT00240227|B1|Baseline|All Study Paricipants|"Placebo no active medication~placebo~Prazosin~FDA approved medication for hypertension"
707157|NCT00240227|P1|Participant Flow|All Study Participants|"Placebo no active medication~placebo~Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
707158|NCT00240227|O2|Outcome|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
707159|NCT00240227|O1|Outcome|Placebo|"Placebo no active medication~placebo"
707160|NCT00240227|E2|Reported Event|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
707161|NCT00240227|E1|Reported Event|Placebo|"Placebo no active medication~placebo"
707162|NCT00240162|B1|Baseline|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
707189|NCT00240097|E1|Reported Event|Regimen A First Cycle|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
707163|NCT00240162|P1|Participant Flow|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
707164|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
707165|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
707166|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
707167|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
707168|NCT00240162|E1|Reported Event|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
707169|NCT00240110|B3|Baseline|Total|Total of all reporting groups
707170|NCT00240110|B2|Baseline|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
707171|NCT00240110|B1|Baseline|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
707172|NCT00240110|P2|Participant Flow|Lithium Carbonate Add on Valproate|Lithium carbonate started and participants randomized to valproate
707173|NCT00240110|P1|Participant Flow|Lithium Carbonate Add on Placebo|Lithium started and then participants randomized to placebo
707174|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Open label lithium carbonate as standard treatment and double blinded valproate
707175|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Open label lithium carbonate as standard treatment and double blinded placebo
707176|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
707177|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
707178|NCT00240110|E2|Reported Event|Lithium Carbonate Add on Valproate|Lithium carbonate as standard treatment add on double blind valproate
707179|NCT00240110|E1|Reported Event|Lithium Carbonate Add on Placebo|Lithium carbonate as standard treatment add on double blind placebo
707180|NCT00240097|B1|Baseline|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks.
707181|NCT00240097|P1|Participant Flow|Regimen A and B|"Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)~Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)"
707182|NCT00240097|O1|Outcome|Part II - After Relapse|Study dosing with A and B based on relapse
707183|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
707184|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
707185|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
707186|NCT00240097|E4|Reported Event|Regimen B Overall Toxicity|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
707187|NCT00240097|E3|Reported Event|Regimen A Overall Toxicity|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
709859|NCT00224029|O1|Outcome|Oxybutynin Transdermal System|
707190|NCT00240071|B1|Baseline|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
707191|NCT00240071|P1|Participant Flow|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
707192|NCT00240071|O1|Outcome|Avastin|"The patient will continue the same hormonal therapy used prior to study enrollment but will combine it with Avastin.~Avastin: All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken off study.~Hormonal therapy: aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or SERM (tamoxifen 20mg/d PO)"
707193|NCT00240071|O1|Outcome|Avastin (Bevacizumab) Plus Hormone|All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
707194|NCT00240071|E1|Reported Event|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
707195|NCT00239928|B1|Baseline|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707196|NCT00239928|P1|Participant Flow|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707197|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707198|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707199|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707200|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707201|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707202|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707203|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707204|NCT00239928|E1|Reported Event|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
707205|NCT00239837|B3|Baseline|Total|Total of all reporting groups
707206|NCT00239837|B2|Baseline|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707207|NCT00239837|B1|Baseline|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707208|NCT00239837|P2|Participant Flow|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707209|NCT00239837|P1|Participant Flow|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707210|NCT00239837|O2|Outcome|Foster Care Services as Usual|Foster Care Services as Usual: Participants continue with usual foster care
707272|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707273|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707274|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707275|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707211|NCT00239837|O1|Outcome|Middle School Success Intervention (MSS)|"Middle School Success Intervention (MSS): Participants receive the preventative intervention~Middle School Success Intervention (MSS): This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school."
707212|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707213|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707214|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707215|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707216|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707217|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707218|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707276|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707277|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707219|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707220|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707221|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707222|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707223|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707224|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707225|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707226|NCT00239837|E2|Reported Event|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
707227|NCT00239837|E1|Reported Event|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
707228|NCT00239733|B1|Baseline|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
707229|NCT00239733|P1|Participant Flow|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
707230|NCT00239733|O1|Outcome|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
707231|NCT00239733|O1|Outcome|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
707232|NCT00239733|E1|Reported Event|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
707233|NCT00239720|B3|Baseline|Total|Total of all reporting groups
707234|NCT00239720|B2|Baseline|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
707235|NCT00239720|B1|Baseline|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
707236|NCT00239720|P2|Participant Flow|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
707237|NCT00239720|P1|Participant Flow|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
707238|NCT00239720|O2|Outcome|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
707239|NCT00239720|O1|Outcome|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
707240|NCT00239720|E2|Reported Event|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
707241|NCT00239720|E1|Reported Event|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
707242|NCT00239681|B3|Baseline|Total|Total of all reporting groups
707243|NCT00239681|B2|Baseline|Placebo|Placebo once daily
707244|NCT00239681|B1|Baseline|Rosuvastatin|Rosuvastatin 20 mg once daily
707245|NCT00239681|P2|Participant Flow|Placebo|Placebo once daily
707246|NCT00239681|P1|Participant Flow|Rosuvastatin|Rosuvastatin 20 mg once daily
707247|NCT00239681|O2|Outcome|Placebo|Placebo once daily
707248|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
707249|NCT00239681|O2|Outcome|Placebo|Placebo once daily
707250|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
707251|NCT00239681|O2|Outcome|Placebo|Placebo once daily
707252|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
707253|NCT00239681|O2|Outcome|Placebo|Placebo once daily
707254|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
707255|NCT00239681|O2|Outcome|Placebo|Placebo once daily
707256|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
707257|NCT00239681|O2|Outcome|Placebo|Placebo once daily
707258|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
707259|NCT00239681|E2|Reported Event|ROSUVASTATIN 20 MG|
707260|NCT00239681|E1|Reported Event|PLACEBO|
707261|NCT00239642|B4|Baseline|Total|Total of all reporting groups
707262|NCT00239642|B3|Baseline|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707263|NCT00239642|B2|Baseline|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707264|NCT00239642|B1|Baseline|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707265|NCT00239642|P3|Participant Flow|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707266|NCT00239642|P2|Participant Flow|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707267|NCT00239642|P1|Participant Flow|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707268|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707269|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707270|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707271|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
709860|NCT00224029|E1|Reported Event|Oxybutynin Transdermal System|
707279|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707280|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707281|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707282|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707283|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707284|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707285|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707286|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707287|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707288|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707289|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707290|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707291|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707292|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707293|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707294|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707295|NCT00239642|E3|Reported Event|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707296|NCT00239642|E2|Reported Event|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707297|NCT00239642|E1|Reported Event|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
707298|NCT00239356|B3|Baseline|Total|Total of all reporting groups
707299|NCT00239356|B2|Baseline|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707300|NCT00239356|B1|Baseline|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707301|NCT00239356|P2|Participant Flow|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707302|NCT00239356|P1|Participant Flow|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707303|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707304|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707305|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707306|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707307|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707308|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707309|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707310|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707311|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707312|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707313|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707314|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707315|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707316|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707317|NCT00239356|E2|Reported Event|Schizophrenia 10 - 30 mg QD|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707318|NCT00239356|E1|Reported Event|Bipolar I Disorder 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
707319|NCT00239226|B5|Baseline|Total|Total of all reporting groups
707320|NCT00239226|B4|Baseline|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
707321|NCT00239226|B3|Baseline|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
707322|NCT00239226|B2|Baseline|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
707323|NCT00239226|B1|Baseline|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
707324|NCT00239226|P4|Participant Flow|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
707325|NCT00239226|P3|Participant Flow|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
707326|NCT00239226|P2|Participant Flow|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
707327|NCT00239226|P1|Participant Flow|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
707328|NCT00239226|O4|Outcome|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
707329|NCT00239226|O3|Outcome|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
707330|NCT00239226|O2|Outcome|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
707331|NCT00239226|O1|Outcome|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
707332|NCT00239226|E4|Reported Event|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
707333|NCT00239226|E3|Reported Event|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
707334|NCT00239226|E2|Reported Event|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
707335|NCT00239226|E1|Reported Event|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
707336|NCT00239005|B3|Baseline|Total|Total of all reporting groups
707337|NCT00239005|B2|Baseline|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
707338|NCT00239005|B1|Baseline|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
707339|NCT00239005|P2|Participant Flow|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
707340|NCT00239005|P1|Participant Flow|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
707341|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
707342|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
707343|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
707344|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
707345|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
707346|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
707347|NCT00239005|E2|Reported Event|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
707348|NCT00239005|E1|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
707349|NCT00238615|B1|Baseline|Group 1|
707350|NCT00238615|P1|Participant Flow|Docetaxel / Carboplatin / XRT + Surgical Resection|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.
707351|NCT00238615|O1|Outcome|Docetaxel+Carboplatin +Radiation+Surgery|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival and progression free survival outcomes.These results are published PMID: 21752720.
707352|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|This planned analysis of gene expression patterns was not performed.
707353|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|"All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint.~Results were published PMID 21774104"
707354|NCT00238615|E1|Reported Event|Docetaxel / Carboplatin / XRT + Surgical Resection|Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720
707355|NCT00238433|B1|Baseline|Busulfan/Melphalan/Thiotepa|"Treatment Plan:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
707356|NCT00238433|P1|Participant Flow|Busulfan/Melphalan/Thiotepa|"Treatment:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) > 1500 for 2 consecutive days."
707357|NCT00238433|O1|Outcome|Busulfan/Melphalan/Thiotepa|"Treatment Plan:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
707358|NCT00238433|O1|Outcome|Busulfan/Melphalan/Thiotepa|"Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Thiotepa: 250 mg/m2/day/iv on days -3 and -2~Procedure/Surgery: bone marrow ablation with stem cell support~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~Growth factor administration: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
707359|NCT00238433|E1|Reported Event|BuMelTT|"*For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.~TREATMENT PLAN:~Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Thiotepa: 250 mg/m2/day/iv on days -3 and -2~Procedure/Surgery: bone marrow ablation with stem cell support~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~Growth factor administration: Filgrastim"
707360|NCT00238420|B3|Baseline|Total|Total of all reporting groups
707361|NCT00238420|B2|Baseline|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
707362|NCT00238420|B1|Baseline|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
707363|NCT00238420|P2|Participant Flow|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
707364|NCT00238420|P1|Participant Flow|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
707365|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
707366|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
707367|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
707368|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
707369|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
707370|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
707371|NCT00238420|E2|Reported Event|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
707372|NCT00238420|E1|Reported Event|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
707373|NCT00238355|B1|Baseline|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
707374|NCT00238355|P1|Participant Flow|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
707375|NCT00238355|O1|Outcome|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
707376|NCT00238355|E1|Reported Event|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
707377|NCT00238303|B4|Baseline|Total|Total of all reporting groups
707378|NCT00238303|B3|Baseline|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707379|NCT00238303|B2|Baseline|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
707380|NCT00238303|B1|Baseline|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707381|NCT00238303|P3|Participant Flow|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707382|NCT00238303|P2|Participant Flow|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
707383|NCT00238303|P1|Participant Flow|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707384|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707385|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
707386|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707387|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707388|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
707389|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707390|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707421|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
709861|NCT00224016|B3|Baseline|Total|Total of all reporting groups
707391|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
707392|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707393|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707394|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
707395|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
707396|NCT00238303|E3|Reported Event|Stratum 3 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
707397|NCT00238303|E2|Reported Event|Stratum 2 (Undergoing Surgery)|surgery : Patients undergo surgery to remove tumor
707398|NCT00238303|E1|Reported Event|Stratum 1 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
707399|NCT00238264|B1|Baseline|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
707400|NCT00238264|P1|Participant Flow|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
707401|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
707402|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
707403|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
707404|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
707405|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
707406|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
707407|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
707408|NCT00238264|E1|Reported Event|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
707409|NCT00238238|B4|Baseline|Total|Total of all reporting groups
707410|NCT00238238|B3|Baseline|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
707411|NCT00238238|B2|Baseline|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
707412|NCT00238238|B1|Baseline|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
707413|NCT00238238|P3|Participant Flow|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
707414|NCT00238238|P2|Participant Flow|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
707415|NCT00238238|P1|Participant Flow|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
707416|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
707417|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
707418|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
707419|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
707420|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
707422|NCT00238238|E3|Reported Event|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
707423|NCT00238238|E2|Reported Event|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
707424|NCT00238238|E1|Reported Event|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
707425|NCT00238121|B3|Baseline|Total|Total of all reporting groups
707426|NCT00238121|B2|Baseline|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707427|NCT00238121|B1|Baseline|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707428|NCT00238121|P2|Participant Flow|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707429|NCT00238121|P1|Participant Flow|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707430|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707431|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707432|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707433|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707434|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707435|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707436|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707437|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
707438|NCT00238121|E1|Reported Event|Sorafenib|
707439|NCT00238108|B3|Baseline|Total|Total of all reporting groups
707440|NCT00238108|B2|Baseline|Placebo|Placebo
707441|NCT00238108|B1|Baseline|Melatonin|Melatonin
707442|NCT00238108|P2|Participant Flow|Placebo|Placebo
707443|NCT00238108|P1|Participant Flow|Melatonin|Melatonin
707444|NCT00238108|O2|Outcome|Placebo|Placebo
707445|NCT00238108|O1|Outcome|Melatonin|Melatonin
707446|NCT00238108|O2|Outcome|Placebo|Placebo
707447|NCT00238108|O1|Outcome|Melatonin|Melatonin
707448|NCT00238108|E2|Reported Event|Placebo|Placebo
707449|NCT00238108|E1|Reported Event|Melatonin|Melatonin
707450|NCT00237809|B5|Baseline|Total|Total of all reporting groups
707451|NCT00237809|B4|Baseline|Placebo/Control|"Placebo/control~Cognitive retraining : Cog rehab"
707452|NCT00237809|B3|Baseline|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707453|NCT00237809|B2|Baseline|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707454|NCT00237809|B1|Baseline|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707455|NCT00237809|P4|Participant Flow|Placebo Drug/ Placebo CRT|Placebo/control
707456|NCT00237809|P3|Participant Flow|D-serine Drug/CRT|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707457|NCT00237809|P2|Participant Flow|Placebo Drug /CRT|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707458|NCT00237809|P1|Participant Flow|D-serine Drug /CRT Placebo|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707459|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707460|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707461|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707462|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707463|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707464|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707465|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707466|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707467|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707468|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707469|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707470|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707471|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707472|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707473|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707474|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707475|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707476|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707477|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707478|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707479|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707480|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707481|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707482|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707483|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707484|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707485|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707486|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707487|NCT00237809|E4|Reported Event|Placebo/Control|"Placebo/control~Cognitive retraining : video"
707488|NCT00237809|E3|Reported Event|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
707489|NCT00237809|E2|Reported Event|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
707490|NCT00237809|E1|Reported Event|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
707491|NCT00237796|B3|Baseline|Total|Total of all reporting groups
707492|NCT00237796|B2|Baseline|Goal Focused Supportive Contact (GFSC)|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707493|NCT00237796|B1|Baseline|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707494|NCT00237796|P2|Participant Flow|Goal Focused Supportive Contact (GFSC)|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707495|NCT00237796|P1|Participant Flow|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707496|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707497|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707498|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707499|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707500|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707501|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707502|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707503|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707504|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707505|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707506|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707507|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707508|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|"Goal Focused Supportive Contact~Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months."
707509|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707510|NCT00237796|E2|Reported Event|Goal Directed Supportive Care|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
707511|NCT00237796|E1|Reported Event|CBSST|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
707512|NCT00237770|B3|Baseline|Total|Total of all reporting groups
707513|NCT00237770|B2|Baseline|Able-bodied Controls|Systolic blood pressure responses to head-up tilt were determined in able-bodied controls following placebo administration
707514|NCT00237770|B1|Baseline|Individuals With Tetraplegia|Systolic blood pressure responses to head-up tilt were determined after placebo, L-NAME (1.0 mg/kg) and L-NAME administration (2.0 mg/kg) administration.
707515|NCT00237770|P2|Participant Flow|Control Subjects|Systolic blood pressure responses to head-up tilt were determined in non-spinal cord injured control subjects following placebo administration. Control subjects visited the laboratory for 1 visit.
707768|NCT00236184|B2|Baseline|Rabeprazole 10 mg|oral enteric-coated tablet
707516|NCT00237770|P1|Participant Flow|Tetraplegic Subjects|All tetraplegic subjects underwent a head-up tilt maneuver to determine systolic blood pressure responses to placebo L-NAME 1.0 mg/kg and L-NAME 2.0 mg/kg. Subjects with tetraplegia visited the laboratory on 3 separate occasions.
707517|NCT00237770|O4|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
707518|NCT00237770|O3|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
707519|NCT00237770|O2|Outcome|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
707520|NCT00237770|O1|Outcome|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
707521|NCT00237770|E4|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
707522|NCT00237770|E3|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
707523|NCT00237770|E2|Reported Event|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
707524|NCT00237770|E1|Reported Event|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
707525|NCT00237744|B4|Baseline|Total|Total of all reporting groups
707526|NCT00237744|B3|Baseline|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand
707527|NCT00237744|B2|Baseline|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand >shoulder/elbow
707528|NCT00237744|B1|Baseline|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
707529|NCT00237744|P3|Participant Flow|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
707530|NCT00237744|P2|Participant Flow|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
707531|NCT00237744|P1|Participant Flow|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
707532|NCT00237744|O3|Outcome|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
707533|NCT00237744|O2|Outcome|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
707534|NCT00237744|O1|Outcome|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
707535|NCT00237744|O3|Outcome|Whole Arm Motor Learning Group|Interventions included whole arm motor learning, FES and Robotics.
707536|NCT00237744|O2|Outcome|Wrist/Hand FES+Whole Arm Motor Learning|The intervention provided in this group included surface FES and whole are motor learning.
707537|NCT00237744|O1|Outcome|Shoulder/Elbow Robotics+Whole Arm Motor Learning|Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
707538|NCT00237744|E3|Reported Event|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow = wrist hand.
707539|NCT00237744|E2|Reported Event|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
707540|NCT00237744|E1|Reported Event|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist/hand> shoulder/elbow.)
707541|NCT00237718|B3|Baseline|Total|Total of all reporting groups
707542|NCT00237718|B2|Baseline|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
707543|NCT00237718|B1|Baseline|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
707544|NCT00237718|P2|Participant Flow|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
707545|NCT00237718|P1|Participant Flow|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
707546|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
707547|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
707548|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
707549|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
707769|NCT00236184|B1|Baseline|Placebo|oral placebo tablet
707550|NCT00237718|E2|Reported Event|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
707551|NCT00237718|E1|Reported Event|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
707552|NCT00237692|B5|Baseline|Total|Total of all reporting groups
707553|NCT00237692|B4|Baseline|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707554|NCT00237692|B3|Baseline|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707555|NCT00237692|B2|Baseline|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707556|NCT00237692|B1|Baseline|Arm 1- Control|A group of hypertensive patients who receive usual care
707557|NCT00237692|P4|Participant Flow|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707558|NCT00237692|P3|Participant Flow|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707559|NCT00237692|P2|Participant Flow|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707560|NCT00237692|P1|Participant Flow|Arm 1- Control|A group of hypertensive patients who receive usual care
707561|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707562|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707563|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707564|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
707565|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707566|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707567|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707568|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
707569|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707570|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707571|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707572|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
707573|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707574|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707575|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707576|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
707577|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707578|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707579|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707580|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
707581|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707582|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707583|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707584|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
707585|NCT00237692|E4|Reported Event|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
707586|NCT00237692|E3|Reported Event|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
707587|NCT00237692|E2|Reported Event|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
707588|NCT00237692|E1|Reported Event|Arm 1- Control|A group of hypertensive patients who receive usual care
707589|NCT00237666|B1|Baseline|Ziprasidone|
707687|NCT00236977|E2|Reported Event|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707590|NCT00237666|P1|Participant Flow|Ziprasidone|Patients will receive 8 weeks of active treatment with ziprasidone, initiated at 20mg BID. Depending on tolerability and clinical response, the dosage can be titrated up to a maximum of 60mg BID per day. Dosage can be lowered or temporarily stopped if necessary because of adverse events.
707591|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
707592|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
707593|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
707594|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
707595|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
707596|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
707597|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
707598|NCT00237666|E1|Reported Event|Ziprasidone|
707599|NCT00237458|B1|Baseline|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707600|NCT00237458|P1|Participant Flow|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707601|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707602|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707603|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707604|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707605|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707606|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707607|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707608|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707609|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707610|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707611|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707612|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707613|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707614|NCT00237458|E1|Reported Event|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
707615|NCT00237185|B3|Baseline|Total|Total of all reporting groups
707616|NCT00237185|B2|Baseline|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707617|NCT00237185|B1|Baseline|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707618|NCT00237185|P2|Participant Flow|Imatinib Mesylate 600 mg|imatinib mesylate 600 mg once daily
707619|NCT00237185|P1|Participant Flow|Imatinib Mesylate 400 mg|imatinib mesylate 400 mg once daily
707620|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707621|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707622|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707623|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707624|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707625|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707626|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707627|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707628|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707629|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707630|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707631|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707632|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707633|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707634|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707635|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707636|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707637|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707638|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707639|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707640|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707641|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707642|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
707643|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
707644|NCT00237185|E2|Reported Event|Imatinib Mesylate 600 mg|600 mg
707645|NCT00237185|E1|Reported Event|Imatinib Mesylate 400 mg|400 mg
707646|NCT00237042|B4|Baseline|Total|Total of all reporting groups
707647|NCT00237042|B3|Baseline|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
707648|NCT00237042|B2|Baseline|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
707649|NCT00237042|B1|Baseline|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
707650|NCT00237042|P3|Participant Flow|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
707651|NCT00237042|P2|Participant Flow|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
707652|NCT00237042|P1|Participant Flow|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
707653|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
707654|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
707655|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
707656|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
707657|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
707658|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
707659|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
707660|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
707688|NCT00236977|E1|Reported Event|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707689|NCT00236951|B5|Baseline|Total|Total of all reporting groups
707690|NCT00236951|B4|Baseline|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
707770|NCT00236184|P2|Participant Flow|Rabeprazole 10 mg|
707771|NCT00236184|P1|Participant Flow|Placebo|
707772|NCT00236184|O2|Outcome|Rabeprazole 10 mg|
707661|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
707662|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
707663|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
707664|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
707665|NCT00237042|E3|Reported Event|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
707666|NCT00237042|E2|Reported Event|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
707667|NCT00237042|E1|Reported Event|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
707668|NCT00236977|B3|Baseline|Total|Total of all reporting groups
707669|NCT00236977|B2|Baseline|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707670|NCT00236977|B1|Baseline|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707671|NCT00236977|P2|Participant Flow|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707672|NCT00236977|P1|Participant Flow|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707673|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707674|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707675|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707676|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707677|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707678|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707679|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707680|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707681|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707682|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707683|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707684|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707685|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
707686|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
707691|NCT00236951|B3|Baseline|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707692|NCT00236951|B2|Baseline|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
707693|NCT00236951|B1|Baseline|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707694|NCT00236951|P4|Participant Flow|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
707695|NCT00236951|P3|Participant Flow|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707696|NCT00236951|P2|Participant Flow|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
707697|NCT00236951|P1|Participant Flow|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707698|NCT00236951|O4|Outcome|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
707699|NCT00236951|O3|Outcome|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707700|NCT00236951|O2|Outcome|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
707701|NCT00236951|O1|Outcome|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707702|NCT00236951|E4|Reported Event|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
707703|NCT00236951|E3|Reported Event|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707704|NCT00236951|E2|Reported Event|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
707705|NCT00236951|E1|Reported Event|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
707706|NCT00236938|B3|Baseline|Total|Total of all reporting groups
707707|NCT00236938|B2|Baseline|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
707708|NCT00236938|B1|Baseline|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
707709|NCT00236938|P2|Participant Flow|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
707710|NCT00236938|P1|Participant Flow|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
707711|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
707712|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
707713|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
707714|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
707715|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
707716|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
707717|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
707758|NCT00236197|B3|Baseline|Total|Total of all reporting groups
707718|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
707719|NCT00236938|E2|Reported Event|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
707720|NCT00236938|E1|Reported Event|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
707721|NCT00236899|B5|Baseline|Total|Total of all reporting groups
707722|NCT00236899|B4|Baseline|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707723|NCT00236899|B3|Baseline|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707724|NCT00236899|B2|Baseline|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707725|NCT00236899|B1|Baseline|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707726|NCT00236899|P4|Participant Flow|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707727|NCT00236899|P3|Participant Flow|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707728|NCT00236899|P2|Participant Flow|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707729|NCT00236899|P1|Participant Flow|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707730|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707731|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707732|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707733|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707734|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707759|NCT00236197|B2|Baseline|Rabeprazole 10 mg|
707760|NCT00236197|B1|Baseline|Placebo|
707761|NCT00236197|P2|Participant Flow|Rabeprazole 10 mg|
707762|NCT00236197|P1|Participant Flow|Placebo|
707735|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707736|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707737|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707738|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707739|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707740|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707741|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707742|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
707743|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707744|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
707745|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707746|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707763|NCT00236197|O2|Outcome|Rabeprazole 10 mg|
707764|NCT00236197|O1|Outcome|Placebo|
707765|NCT00236197|E2|Reported Event|Rabeprazole 10 mg|
707747|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707748|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
707749|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707750|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707751|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707752|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707753|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707754|NCT00236899|E4|Reported Event|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707755|NCT00236899|E3|Reported Event|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707756|NCT00236899|E2|Reported Event|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707757|NCT00236899|E1|Reported Event|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
707777|NCT00236080|B5|Baseline|Placebo|Matching placebo tablets once daily only on nights worked
707778|NCT00236080|B4|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
707779|NCT00236080|B3|Baseline|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
707780|NCT00236080|B2|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
707781|NCT00236080|B1|Baseline|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
707782|NCT00236080|P5|Participant Flow|Placebo|Matching placebo tablets once daily only on nights worked
707783|NCT00236080|P4|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
707784|NCT00236080|P3|Participant Flow|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
707785|NCT00236080|P2|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
707786|NCT00236080|P1|Participant Flow|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
707787|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
707788|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
707789|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
707790|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
707791|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
707792|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
707793|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
707794|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
707795|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
707796|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
707797|NCT00236080|E5|Reported Event|Placebo|Matching placebo tablets once daily only on nights worked
707798|NCT00236080|E4|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
707799|NCT00236080|E3|Reported Event|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
707800|NCT00236080|E2|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
707801|NCT00236080|E1|Reported Event|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
707802|NCT00235989|B5|Baseline|Total|Total of all reporting groups
707803|NCT00235989|B4|Baseline|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
707804|NCT00235989|B3|Baseline|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
707805|NCT00235989|B2|Baseline|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
707806|NCT00235989|B1|Baseline|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
707807|NCT00235989|P6|Participant Flow|CT: IFNB-1b 500mcg|Core Treatment 500 mcg
707808|NCT00235989|P5|Participant Flow|CT: IFNB-1b 250mcg|Core Treatment 250 mcg
707809|NCT00235989|P4|Participant Flow|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
707810|NCT00235989|P3|Participant Flow|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
707811|NCT00235989|P2|Participant Flow|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
707812|NCT00235989|P1|Participant Flow|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
707813|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
707814|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
707815|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
707816|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
707817|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
707818|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
707819|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
707820|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
707821|NCT00235989|E4|Reported Event|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
707822|NCT00235989|E3|Reported Event|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
707823|NCT00235989|E2|Reported Event|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
707824|NCT00235989|E1|Reported Event|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
707825|NCT00235872|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707826|NCT00235872|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707827|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707828|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707829|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707830|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707831|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707832|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707833|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
709862|NCT00224016|B2|Baseline|Oral Oxybutynin|Oxybutynin tablets
707834|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707835|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707836|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707837|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707838|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707839|NCT00235872|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
707840|NCT00235833|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707841|NCT00235833|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707842|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707843|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707844|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707845|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707846|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707847|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707848|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707849|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707850|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707851|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707852|NCT00235833|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
707853|NCT00235755|B4|Baseline|Total|Total of all reporting groups
707854|NCT00235755|B3|Baseline|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707855|NCT00235755|B2|Baseline|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707856|NCT00235755|B1|Baseline|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
707857|NCT00235755|P3|Participant Flow|Retigabine 300 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase.
707858|NCT00235755|P2|Participant Flow|Retigabine 200 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase.
707859|NCT00235755|P1|Participant Flow|Placebo|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase. Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase.
707860|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707861|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707862|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707863|NCT00235755|O3|Outcome|Retigabine 300 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase
707864|NCT00235755|O2|Outcome|Retigabine 200 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase
707865|NCT00235755|O1|Outcome|Placebo: Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase
707866|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
707867|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
707868|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
707869|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707870|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707871|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707872|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
707873|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
707874|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
707875|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707876|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707877|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707878|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707879|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707880|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707881|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707882|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707949|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
708565|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
707883|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707884|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707885|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707886|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707887|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707888|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707889|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707890|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707891|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707892|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707893|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707894|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707895|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707896|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707897|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707898|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707899|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707900|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707901|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707950|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
709312|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
707902|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707903|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707904|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707905|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707906|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707907|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707908|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707909|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707910|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707911|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707912|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707913|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707914|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707915|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707916|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707917|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707918|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707919|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
707920|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707921|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707922|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12 week Maintenance Phase
707923|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707924|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707925|NCT00235755|O1|Outcome|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
707926|NCT00235755|E6|Reported Event|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
707927|NCT00235755|E5|Reported Event|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
707928|NCT00235755|E4|Reported Event|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
707929|NCT00235755|E3|Reported Event|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
707930|NCT00235755|E2|Reported Event|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
707931|NCT00235755|E1|Reported Event|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
707932|NCT00235716|B5|Baseline|Total|Total of all reporting groups
707933|NCT00235716|B4|Baseline|Placebo|Matching placebo pills for vitamin E and memantine
707934|NCT00235716|B3|Baseline|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707935|NCT00235716|B2|Baseline|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707936|NCT00235716|B1|Baseline|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707937|NCT00235716|P4|Participant Flow|Placebo|Matching placebo pills for vitamin E and memantine
707938|NCT00235716|P3|Participant Flow|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707939|NCT00235716|P2|Participant Flow|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707940|NCT00235716|P1|Participant Flow|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707941|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
707942|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707943|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707944|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707945|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
707946|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707947|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707948|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707951|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707952|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707953|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
707954|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707955|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707956|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707957|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
707958|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707959|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707960|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707961|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
707962|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707963|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707964|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707965|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
707966|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707967|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707968|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707969|NCT00235716|E4|Reported Event|Placebo|Matching placebo pills for vitamin E and memantine
707970|NCT00235716|E3|Reported Event|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
707971|NCT00235716|E2|Reported Event|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
707972|NCT00235716|E1|Reported Event|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
707973|NCT00235573|B1|Baseline|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
707974|NCT00235573|P1|Participant Flow|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
707975|NCT00235573|O1|Outcome|Vitamin B12 Group|All subjects received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
707976|NCT00235573|E1|Reported Event|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
707977|NCT00235456|B3|Baseline|Total|Total of all reporting groups
707978|NCT00235456|B2|Baseline|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707979|NCT00235456|B1|Baseline|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707980|NCT00235456|P2|Participant Flow|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707981|NCT00235456|P1|Participant Flow|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707982|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
708003|NCT00235443|P6|Participant Flow|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
707983|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707984|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707985|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707986|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707987|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707988|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707989|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707990|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707991|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707992|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707993|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707994|NCT00235456|E2|Reported Event|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707995|NCT00235456|E1|Reported Event|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
707996|NCT00235443|B7|Baseline|Total|Total of all reporting groups
707997|NCT00235443|B6|Baseline|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
707998|NCT00235443|B5|Baseline|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
707999|NCT00235443|B4|Baseline|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708000|NCT00235443|B3|Baseline|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708001|NCT00235443|B2|Baseline|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708002|NCT00235443|B1|Baseline|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708264|NCT00234104|O2|Outcome|15 mg of OPC-41061|OPC-41061 15 mg/day
708004|NCT00235443|P5|Participant Flow|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708005|NCT00235443|P4|Participant Flow|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708006|NCT00235443|P3|Participant Flow|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708007|NCT00235443|P2|Participant Flow|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708008|NCT00235443|P1|Participant Flow|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708009|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708010|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708011|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708012|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708013|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708014|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708015|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708016|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708017|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708018|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708019|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708020|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708021|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708022|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708023|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708024|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708025|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708026|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708027|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708028|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708029|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708030|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708031|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708032|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708033|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708034|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708035|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708036|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708037|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708038|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708039|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708040|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708041|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708042|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708043|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708044|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708045|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708046|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708047|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708048|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708049|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708050|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708051|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708052|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708053|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708054|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708055|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708056|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708057|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708058|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708059|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708060|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708061|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708062|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708063|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708064|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708065|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708066|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708067|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708068|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708069|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708070|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708071|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708072|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708073|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708074|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708075|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708076|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708077|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708078|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708079|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708080|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708081|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708082|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708083|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708084|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708085|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708086|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708087|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708088|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708089|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708090|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708091|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708092|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708093|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708094|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708095|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708096|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708097|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708098|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708099|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708100|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708101|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708102|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708103|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708104|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708105|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708106|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708107|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708108|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708109|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708110|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708111|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708112|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708113|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708114|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708115|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708116|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708117|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708118|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708119|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708120|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708121|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708122|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708123|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708124|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708125|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708126|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708127|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708128|NCT00235443|O7|Outcome|Total|All modal dose groups combined
708129|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708130|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708131|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708132|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708133|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708134|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708135|NCT00235443|E7|Reported Event|Total|All modal dose groups combined
708136|NCT00235443|E6|Reported Event|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708137|NCT00235443|E5|Reported Event|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708138|NCT00235443|E4|Reported Event|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708139|NCT00235443|E3|Reported Event|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708140|NCT00235443|E2|Reported Event|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708141|NCT00235443|E1|Reported Event|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
708142|NCT00235391|B7|Baseline|Total|Total of all reporting groups
708143|NCT00235391|B6|Baseline|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708144|NCT00235391|B5|Baseline|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708145|NCT00235391|B4|Baseline|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708146|NCT00235391|B3|Baseline|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708147|NCT00235391|B2|Baseline|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708148|NCT00235391|B1|Baseline|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708149|NCT00235391|P6|Participant Flow|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708150|NCT00235391|P5|Participant Flow|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708151|NCT00235391|P4|Participant Flow|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708152|NCT00235391|P3|Participant Flow|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708153|NCT00235391|P2|Participant Flow|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708154|NCT00235391|P1|Participant Flow|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708155|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708156|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708157|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708158|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708159|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708160|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708161|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708162|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708163|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708164|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708165|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708265|NCT00234104|O1|Outcome|Placebo|OPC-41061 0 mg/day
708266|NCT00234104|E4|Reported Event|45 mg of OPC-41061|OPC-41061 45 mg/day
708166|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708167|NCT00235391|E1|Reported Event|All Participants|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
708168|NCT00235326|B3|Baseline|Total|Total of all reporting groups
708169|NCT00235326|B2|Baseline|Exposed to Gastroenteritis|
708170|NCT00235326|B1|Baseline|Unexposed to Gastroenteritis|
708171|NCT00235326|P2|Participant Flow|Exposed to Gastroenteritis|
708172|NCT00235326|P1|Participant Flow|Unexposed to Gastroenteritis|
708173|NCT00235326|O2|Outcome|Exposed to Gastroenteritis|
708174|NCT00235326|O1|Outcome|Unexposed to Gastroenteritis|
708175|NCT00234884|B1|Baseline|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708176|NCT00234884|P1|Participant Flow|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708177|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708178|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708179|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708180|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708181|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708182|NCT00234884|E1|Reported Event|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
708183|NCT00234832|B3|Baseline|Total|Total of all reporting groups
708184|NCT00234832|B2|Baseline|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708185|NCT00234832|B1|Baseline|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708186|NCT00234832|P2|Participant Flow|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708187|NCT00234832|P1|Participant Flow|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708188|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708189|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708190|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708191|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708192|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708193|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708194|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708195|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708196|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708197|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708267|NCT00234104|E3|Reported Event|30 mg of OPC-41061|OPC-41061 30 mg/day
708198|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708199|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708200|NCT00234832|O8|Outcome|CV + DM Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
708201|NCT00234832|O7|Outcome|CV + DM Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
708202|NCT00234832|O6|Outcome|CV Only Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
708203|NCT00234832|O5|Outcome|CV Only Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
708204|NCT00234832|O4|Outcome|DM Only Randomized to Placebo|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
708205|NCT00234832|O3|Outcome|DM Only Randomized to Sibutramine|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
708206|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708207|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
708208|NCT00234832|E3|Reported Event|Randomized Placebo|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
708209|NCT00234832|E2|Reported Event|Randomized Sibutramine|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
708210|NCT00234832|E1|Reported Event|Lead-in Period Sibutramine|Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.
708211|NCT00234494|B1|Baseline|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
708212|NCT00234494|P1|Participant Flow|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
708213|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
708214|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
708215|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
708216|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
708217|NCT00234494|E1|Reported Event|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
708218|NCT00234286|B1|Baseline|Arm 1|"Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials"
708268|NCT00234104|E2|Reported Event|15 mg of OPC-41061|OPC-41061 15 mg/day
708269|NCT00234104|E1|Reported Event|Placebo|OPC-41061 0 mg/day
708270|NCT00234078|B5|Baseline|Total|Total of all reporting groups
708219|NCT00234286|P1|Participant Flow|BEACON Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
708220|NCT00234286|O2|Outcome|Post-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
708221|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
708222|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Advanced Directive post-intervention based on abstraction of medical record
708223|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Advanced Directive pre-intervention based on abstraction of medical record
708224|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Pastoral Care visit post-intervention based on abstraction of medical record
708225|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Pastoral Care Visit pre-intervention based on abstraction of medical record
708226|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Sublingual administration of medication during post-intervention based on abstraction of medical record
708227|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Sublingual administration of medication during pre-intervention based on abstraction of medical record
708228|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of scopolamine (for death rattle) during post -intervention based on abstraction of medical record
708229|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of scopolamine (for death rattle) during pre-intervention based on abstraction of medical record
708230|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of benzodiazepine medication during post-intervention based on abstraction of medical record
708231|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of benzodiazepine medication during pre-intervention based on abstraction of medical record
708232|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Order for benzodiazepine medication during post-intervention period based on abstraction of medical record
708233|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Order for benzodiazepine medication during pre-intervention period based on abstraction of medical record
708234|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of antipsychotic medication post-intervention
708235|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of antipsychotic medication pre-intervention
708236|NCT00234286|O2|Outcome|Post-Intervention|Individuals with antipsychotic medication ordered post-intervention
708237|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with antipsychotic medication ordered pre-intervention
708238|NCT00234286|O2|Outcome|Post-intervention|Individuals who received opioid medication post-intervention
708239|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who received opioid medication pre-intervention
708240|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with restraints during post-intervention
708241|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with restraints during pre-intervention
708242|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with an intravenous line post-intervention
708243|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with an intravenous line pre-intervention
708244|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with a nasogastric tube post-intervention
708245|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with a nasogastric tube pre-intervention
708246|NCT00234286|O2|Outcome|Post-Intervention|Number of Patients who died in ICU Post-Intervention
708247|NCT00234286|O1|Outcome|Pre-Intervention|Number of Individuals who died in ICU Pre-Intervention
708248|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
708249|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
708250|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
708251|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
708252|NCT00234286|E1|Reported Event|Arm 1|Arm 1: Comfort care education intervention, consisting of intensive, on-site staff training
708253|NCT00234104|B5|Baseline|Total|Total of all reporting groups
708254|NCT00234104|B4|Baseline|45 mg of OPC-41061|OPC-41061 45 mg/day
708255|NCT00234104|B3|Baseline|30 mg of OPC-41061|OPC-41061 30 mg/day
708256|NCT00234104|B2|Baseline|15 mg of OPC-41061|OPC-41061 15 mg/day
708257|NCT00234104|B1|Baseline|Placebo|OPC-41061 0 mg/day
708258|NCT00234104|P4|Participant Flow|45 mg of OPC-41061|OPC-41061 45 mg/day
708259|NCT00234104|P3|Participant Flow|30 mg of OPC-41061|OPC-41061 30 mg/day
708260|NCT00234104|P2|Participant Flow|15 mg of OPC-41061|OPC-41061 15 mg/day
708261|NCT00234104|P1|Participant Flow|Placebo|OPC-41061 0 mg/day
708262|NCT00234104|O4|Outcome|45 mg of OPC-41061|OPC-41061 45 mg/day
708263|NCT00234104|O3|Outcome|30 mg of OPC-41061|OPC-41061 30 mg/day
708271|NCT00234078|B4|Baseline|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708272|NCT00234078|B3|Baseline|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708273|NCT00234078|B2|Baseline|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708274|NCT00234078|B1|Baseline|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708275|NCT00234078|P4|Participant Flow|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708276|NCT00234078|P3|Participant Flow|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708277|NCT00234078|P2|Participant Flow|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708278|NCT00234078|P1|Participant Flow|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708279|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708280|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708281|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708282|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708283|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708284|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708285|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708286|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708287|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708288|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708289|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708290|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708291|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708292|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708293|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708294|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708295|NCT00234078|E4|Reported Event|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708296|NCT00234078|E3|Reported Event|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708297|NCT00234078|E2|Reported Event|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708298|NCT00234078|E1|Reported Event|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
708299|NCT00234065|B3|Baseline|Total|Total of all reporting groups
708300|NCT00234065|B2|Baseline|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708301|NCT00234065|B1|Baseline|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708302|NCT00234065|P2|Participant Flow|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708303|NCT00234065|P1|Participant Flow|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708304|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708305|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708306|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708307|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708308|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708309|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708310|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708311|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708312|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708313|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708314|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708315|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708316|NCT00234065|E2|Reported Event|Aspirin|Aspirin, oral tablet, 81 mg aspirin
708317|NCT00234065|E1|Reported Event|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
708318|NCT00234039|B1|Baseline|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
708319|NCT00234039|P1|Participant Flow|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
708320|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
708321|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
708322|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
708323|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
708324|NCT00234039|E1|Reported Event|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
708325|NCT00233987|B1|Baseline|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
708326|NCT00233987|P1|Participant Flow|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells.
708327|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
708328|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
708329|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
708330|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
708331|NCT00233987|E1|Reported Event|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
708332|NCT00233948|B3|Baseline|Total|Total of all reporting groups
708333|NCT00233948|B2|Baseline|Phase II|Oral Nelfinavir at 3000 mg bid
708334|NCT00233948|B1|Baseline|Phase I|Phase I dose escalation portion of the study. Initial dose of oral Nelfinavir was 1250 mg bid with escalation to the MTD at 4250 mg bid using a standard 3+3 dose escalation scheme.
708335|NCT00233948|P6|Participant Flow|Phase II|Oral Nelfinavir at 3000mg bid
708336|NCT00233948|P5|Participant Flow|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
708337|NCT00233948|P4|Participant Flow|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
708338|NCT00233948|P3|Participant Flow|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
708339|NCT00233948|P2|Participant Flow|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
708340|NCT00233948|P1|Participant Flow|Phase I: Dose Level 1|Oral Nelfinavir at 1250mg bid.
708341|NCT00233948|O1|Outcome|Phase II|Oral Nelfinavir at 3000 mg bid
708342|NCT00233948|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
708343|NCT00233948|O5|Outcome|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
708344|NCT00233948|O4|Outcome|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
708345|NCT00233948|O3|Outcome|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
708346|NCT00233948|O2|Outcome|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
708347|NCT00233948|O1|Outcome|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
708348|NCT00233948|E6|Reported Event|Phase II|Oral Nelfinavir at 3000 mg bid
708349|NCT00233948|E5|Reported Event|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
708350|NCT00233948|E4|Reported Event|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
708351|NCT00233948|E3|Reported Event|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
708352|NCT00233948|E2|Reported Event|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
708353|NCT00233948|E1|Reported Event|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
708354|NCT00233519|B3|Baseline|Total|Total of all reporting groups
708355|NCT00233519|B2|Baseline|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
708356|NCT00233519|B1|Baseline|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
709313|NCT00227903|O1|Outcome|Brief Advice|Advice and education
708357|NCT00233519|P2|Participant Flow|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
708358|NCT00233519|P1|Participant Flow|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
708359|NCT00233519|O2|Outcome|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
708360|NCT00233519|O1|Outcome|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
708361|NCT00233519|E2|Reported Event|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
708362|NCT00233519|E1|Reported Event|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
708363|NCT00233454|B1|Baseline|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
708364|NCT00233454|P1|Participant Flow|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
708365|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
708366|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
708367|NCT00233454|E1|Reported Event|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
708368|NCT00233402|B3|Baseline|Total|Total of all reporting groups
708369|NCT00233402|B2|Baseline|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
708370|NCT00233402|B1|Baseline|Comparator|Standard White Light Cystoscopy
708371|NCT00233402|P2|Participant Flow|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
708372|NCT00233402|P1|Participant Flow|Comparator|Standard White Light Cystoscopy
708373|NCT00233402|O1|Outcome|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
708374|NCT00233402|O2|Outcome|White Light Group|
708375|NCT00233402|O1|Outcome|Hexvix Group|
708376|NCT00233402|O2|Outcome|White Light Group|
708377|NCT00233402|O1|Outcome|Hexvix Group|
708378|NCT00233402|O2|Outcome|White Light Group|
708379|NCT00233402|O1|Outcome|Hexvix Group|The primary endpoint was assessed from patients randomized to the Hexvix group only
708380|NCT00233402|E2|Reported Event|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
708381|NCT00233402|E1|Reported Event|Comparator|Standard White Light Cystoscopy
708382|NCT00233324|B5|Baseline|Total|Total of all reporting groups
708383|NCT00233324|B4|Baseline|Early Surfactant and Higher Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)
708384|NCT00233324|B3|Baseline|Early Surfactant and Lower Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)
708385|NCT00233324|B2|Baseline|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%)
708386|NCT00233324|B1|Baseline|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%)
708387|NCT00233324|P4|Participant Flow|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
708388|NCT00233324|P3|Participant Flow|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
708389|NCT00233324|P2|Participant Flow|Early Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
708390|NCT00233324|P1|Participant Flow|Early Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
708391|NCT00233324|O4|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
708392|NCT00233324|O3|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
708393|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
708394|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
708395|NCT00233324|O2|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
708396|NCT00233324|O1|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
708397|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
708398|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
708399|NCT00233324|E4|Reported Event|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
708400|NCT00233324|E3|Reported Event|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
708401|NCT00233324|E2|Reported Event|Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
708402|NCT00233324|E1|Reported Event|Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
708403|NCT00233103|B3|Baseline|Total|Total of all reporting groups
708404|NCT00233103|B2|Baseline|Placebo|Placebo for 10 weeks
708405|NCT00233103|B1|Baseline|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
708406|NCT00233103|P2|Participant Flow|Placebo|Placebo for 10 weeks
708407|NCT00233103|P1|Participant Flow|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) for 10 weeks
708408|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
708409|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
708410|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
708411|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
708412|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
708413|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
708414|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
708415|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
708416|NCT00233103|E2|Reported Event|Placebo|Placebo for 10 weeks
708417|NCT00233103|E1|Reported Event|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
708418|NCT00233090|B3|Baseline|Total|Total of all reporting groups
708419|NCT00233090|B2|Baseline|Placebo|daily dose of placebo for four weeks
708420|NCT00233090|B1|Baseline|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708421|NCT00233090|P2|Participant Flow|Placebo|daily dose of placebo for four weeks
708422|NCT00233090|P1|Participant Flow|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708423|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708424|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708425|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708426|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708427|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708428|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708429|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708430|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708431|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708432|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708433|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708434|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708435|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708436|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708437|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
708438|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708439|NCT00233090|E2|Reported Event|Placebo|daily dose of placebo for four weeks
708440|NCT00233090|E1|Reported Event|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
708441|NCT00233064|B3|Baseline|Total|Total of all reporting groups
708442|NCT00233064|B2|Baseline|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
708443|NCT00233064|B1|Baseline|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
708444|NCT00233064|P2|Participant Flow|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
708445|NCT00233064|P1|Participant Flow|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
708446|NCT00233064|O3|Outcome|Combined Liquid/Lyophilized Palivizumab|
708447|NCT00233064|O2|Outcome|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
708448|NCT00233064|O1|Outcome|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
708449|NCT00233064|E2|Reported Event|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
708450|NCT00233064|E1|Reported Event|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
708451|NCT00232739|B1|Baseline|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708452|NCT00232739|P1|Participant Flow|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708453|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708454|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708455|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708456|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708457|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708458|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708459|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708460|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708461|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708462|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708463|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708464|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708465|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708466|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708467|NCT00232739|E1|Reported Event|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
708468|NCT00232596|B3|Baseline|Total|Total of all reporting groups
708469|NCT00232596|B2|Baseline|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708470|NCT00232596|B1|Baseline|Placebo - Double-blind (DB) Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708471|NCT00232596|P2|Participant Flow|Retigabine|Titration Phase: retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID with a starting daily dose of 300 mg/day (in 3 equally divided doses). The dose increased weekly by 150 mg/day (50 mg TID) for the 6 weeks of the Titration Phase to a target daily dose of 1200 mg/day (400 mg TID) by the beginning of Week 7 of treatment. Maintenance Phase: Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks in participants who tolerated this dose. Participants who could not tolerate the 1200 mg/day dose were allowed to reduce the dose to 1050 mg/day (350 mg TID) at the end of the first week and then maintain this dose for the remainder of the 12 weeks.
708472|NCT00232596|P1|Participant Flow|Placebo|Titration Phase: matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 6 weeks. Maintenance Phase: matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks.
708473|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708474|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708475|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708476|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708477|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
708478|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708479|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
708480|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708481|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
708482|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708483|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
708484|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708485|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708486|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708487|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708488|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708489|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708490|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708491|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708492|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708493|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708494|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708495|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708496|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708497|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708498|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708499|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708500|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708501|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708502|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708503|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708504|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708505|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708862|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708506|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708507|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708508|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708509|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID), for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708510|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708511|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708512|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708513|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708514|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
708515|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708516|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708517|NCT00232596|E4|Reported Event|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
708518|NCT00232596|E3|Reported Event|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
708519|NCT00232596|E2|Reported Event|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
708520|NCT00232596|E1|Reported Event|Placebo - Double-blind (DB) Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
708521|NCT00232583|B3|Baseline|Total|Total of all reporting groups
708522|NCT00232583|B2|Baseline|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708523|NCT00232583|B1|Baseline|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708524|NCT00232583|P2|Participant Flow|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708525|NCT00232583|P1|Participant Flow|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708526|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708527|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708528|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708529|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708530|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708531|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708564|NCT00232557|P1|Participant Flow|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
708532|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708533|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708534|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708535|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708536|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708537|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708538|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708539|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708540|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708541|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708542|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708543|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708544|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708545|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708546|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708547|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708548|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708549|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708550|NCT00232583|O2|Outcome|Metformin, Pioglitazone and Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708551|NCT00232583|O1|Outcome|Metfomin and Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708552|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708553|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708554|NCT00232583|O2|Outcome|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708555|NCT00232583|O1|Outcome|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708556|NCT00232583|O2|Outcome|Metformin, GLyburide & Pioglitazone|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708557|NCT00232583|O1|Outcome|Metformin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708558|NCT00232583|E2|Reported Event|Metfomin, Pioglitazone & Glyburide|Metformin 2,000 mg (or maximum tolerated dose); glyburide 1.25 mg BID and 15 mg daily pioglitazone (pioglitazone was titrated monthly to a final dose of 45 mg daily).
708559|NCT00232583|E1|Reported Event|Metfomin & Insulin|Insulin NovoLog 70/30 BID adjusted to target fasting blood glucose level of 70 to 110 mg/dL and postprandial blood sugar < 140 mg/dL and Metformin 2,000 mg/day (or maximum tolerated dose).
708560|NCT00232557|B3|Baseline|Total|Total of all reporting groups
708561|NCT00232557|B2|Baseline|TLC-health Education|A TLC system for providing general health education
708562|NCT00232557|B1|Baseline|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
708563|NCT00232557|P2|Participant Flow|TLC-health Education|A TLC system for providing general health education
708566|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
708567|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
708568|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
708569|NCT00232557|E2|Reported Event|Arm 2|A TLC system for providing general health education
708570|NCT00232557|E1|Reported Event|Arm 1|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
708571|NCT00232544|B3|Baseline|Total|Total of all reporting groups
708572|NCT00232544|B2|Baseline|TLC-Control|A TLC system for providing general health education
708573|NCT00232544|B1|Baseline|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
708574|NCT00232544|P2|Participant Flow|TLC-Control|A TLC system for providing general health education
708575|NCT00232544|P1|Participant Flow|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
708576|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
708577|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
708578|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
708579|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
708580|NCT00232544|E2|Reported Event|TLC-Control|A TLC system for providing general health education
708581|NCT00232544|E1|Reported Event|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
708582|NCT00232505|B3|Baseline|Total|Total of all reporting groups
708583|NCT00232505|B2|Baseline|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
708584|NCT00232505|B1|Baseline|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
708585|NCT00232505|P2|Participant Flow|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
708586|NCT00232505|P1|Participant Flow|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
708587|NCT00232505|O2|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
708588|NCT00232505|O1|Outcome|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
708589|NCT00232505|O2|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
708590|NCT00232505|O1|Outcome|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
708591|NCT00232505|O4|Outcome|Cetuximab and Carboplatin Subset|patients receiving cetuximab and carboplatin who had confirmed basal-like disease by quantitative realtime polymerase chain reaction–based intrinsic subtype assay
708592|NCT00232505|O3|Outcome|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
708593|NCT00232505|O2|Outcome|Cetuximab and Carboplatin After Cetuximab Alone|Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin
708594|NCT00232505|O1|Outcome|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
708595|NCT00232505|E3|Reported Event|Cetuximab and Carboplatin|"Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~carboplatin: Given IV"
708596|NCT00232505|E2|Reported Event|Cetuximab and Carboplatin After Cetuximab Alone|Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin
708597|NCT00232505|E1|Reported Event|Cetuximab|"Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.~cetuximab: Given IV"
708598|NCT00232479|B1|Baseline|Group 1|treat with taxotere, herceptin, carboplatin in dose dense fashion
708599|NCT00232479|P1|Participant Flow|Group 1|study group receives taxotere, herceptin and carboplatin in dose dense fashion
708600|NCT00232479|O1|Outcome|Group 1|patients received herceptin, carboplatin and taxotere in a dose dense fashion.
708601|NCT00232479|O1|Outcome|Group 1|patients received dose dense herceptin, carboplatin and taxotere
708602|NCT00232479|E1|Reported Event|Group 1|patients received herceptin, carboplatin, taxotere in dose dense fashion
708603|NCT00232180|B3|Baseline|Total|Total of all reporting groups
708604|NCT00232180|B2|Baseline|Placebo|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
709869|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
708605|NCT00232180|B1|Baseline|Eplerenone|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708606|NCT00232180|P3|Participant Flow|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
708607|NCT00232180|P2|Participant Flow|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708608|NCT00232180|P1|Participant Flow|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708609|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708610|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708611|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708612|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708613|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708614|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708615|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708616|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708617|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708618|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708619|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708620|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708621|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708622|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708623|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708624|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708625|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708863|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708626|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708627|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708628|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708629|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708630|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708631|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708632|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708633|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708634|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708635|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708636|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708637|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708638|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708639|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708640|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708641|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708642|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708643|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708644|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708645|NCT00232180|E5|Reported Event|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
708646|NCT00232180|E4|Reported Event|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708864|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708647|NCT00232180|E3|Reported Event|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heartfailure therapy. Dose might have been increased at Week 4 to 50 mg once daily.For participants with an estimated glomerular filtration rate (eGFR) between 30 to49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initialdose was 25 mg orally once every other day; at Week 4, dose might have beenincreased to a maximum of 25 mg once daily based on serum potassium level.
708648|NCT00232180|E2|Reported Event|Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
708649|NCT00232180|E1|Reported Event|Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
708650|NCT00232141|B3|Baseline|Total|Total of all reporting groups
708651|NCT00232141|B2|Baseline|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708652|NCT00232141|B1|Baseline|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708653|NCT00232141|P2|Participant Flow|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708654|NCT00232141|P1|Participant Flow|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708655|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708656|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708657|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708658|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708659|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708660|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708661|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708662|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708663|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708664|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708665|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708666|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708667|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708668|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708669|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708670|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708671|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708672|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708673|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708674|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708675|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708676|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708677|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708678|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708679|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708680|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708681|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708682|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708683|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708684|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708685|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708686|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708687|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708688|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708689|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708690|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708691|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708757|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL SC injection administered comcomitantly with 0.5 mL IM influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
708865|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708692|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708693|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708694|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708695|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708696|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708697|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708698|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708699|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708700|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708701|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708702|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708703|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708704|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708705|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708706|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708707|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708708|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708709|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708710|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708711|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708712|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708713|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708758|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
708866|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708714|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708715|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708716|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708717|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708718|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708719|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
708720|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
708721|NCT00231894|B3|Baseline|Total|Total of all reporting groups
708722|NCT00231894|B2|Baseline|Placebo|placebo
708723|NCT00231894|B1|Baseline|Pioglitazone|pioglitazone
708724|NCT00231894|P2|Participant Flow|Placebo|Placebo capsules daily plus life-style diet education group
708725|NCT00231894|P1|Participant Flow|Pioglitazone|Pioglitazone (30-45 mg/daily) plus life-style diet education group
708726|NCT00231894|O2|Outcome|Placebo|Placebo capsules daily plus life-style diet education group
708727|NCT00231894|O1|Outcome|Pioglitazone|Pioglitazone (30-45 mg/daily) plus life-style diet education group
708728|NCT00231894|O2|Outcome|Placebo|Placebo capsules daily plus life-style diet education group
708729|NCT00231894|O1|Outcome|Pioglitazone|Pioglitazone (30-45 mg/daily) plus life-style diet education group
708730|NCT00231894|O2|Outcome|Placebo|Placebo capsules daily plus life-style diet education group
708731|NCT00231894|O1|Outcome|Pioglitazone|Pioglitazone (30-45 mg/daily) plus life-style diet education group
708732|NCT00231894|O2|Outcome|Placebo|Placebo capsules daily plus life-style diet education group
708733|NCT00231894|O1|Outcome|Pioglitazone|Pioglitazone (30-45 mg/daily) plus life-style diet education group
708734|NCT00231894|O2|Outcome|Placebo|placebo
708735|NCT00231894|O1|Outcome|Pioglitazone|pioglitazone
708736|NCT00231894|O2|Outcome|Placebo|placebo and life-style diet group
708737|NCT00231894|O1|Outcome|Pioglitazone|pioglitazone and life-style diet group
708738|NCT00231894|O2|Outcome|Placebo|placebo
708739|NCT00231894|O1|Outcome|Pioglitazone|pioglitazone
708740|NCT00231894|O2|Outcome|Placebo|"placebo and life-style diet group~Life style diet group: life style diet education group 1x/week~placebo: placebo comparator"
708741|NCT00231894|O1|Outcome|Piogltiazone|"pioglitazone and life-style diet group~Pioglitazone: pioglitazone 15-45 mg/day~Life style diet group: life style diet education group 1x/week"
708742|NCT00231894|O2|Outcome|Placebo|placebo and life-style diet group
708743|NCT00231894|O1|Outcome|Pioglitazone|pioglitazone and life-style diet group
708744|NCT00231894|E2|Reported Event|Placebo|placebo
708745|NCT00231894|E1|Reported Event|Pioglitazone|pioglitazone
708746|NCT00231816|B3|Baseline|Total|Total of all reporting groups
708747|NCT00231816|B2|Baseline|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
708748|NCT00231816|B1|Baseline|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
708749|NCT00231816|P2|Participant Flow|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
708750|NCT00231816|P1|Participant Flow|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
708751|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
708752|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
708753|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
708754|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
708755|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
708756|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
709314|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
708759|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
708760|NCT00231816|E2|Reported Event|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
708761|NCT00231816|E1|Reported Event|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
708762|NCT00231777|B3|Baseline|Total|Total of all reporting groups
708763|NCT00231777|B2|Baseline|Ondansetron IV 4 mg|"On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.~The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use.~Data Reported is for all all participants who received active study therapy."
708764|NCT00231777|B1|Baseline|MK0517 Intravenous (IV) 40 mg|"On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.~Data Reported is for all all participants who received active study therapy."
708765|NCT00231777|P2|Participant Flow|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
708766|NCT00231777|P1|Participant Flow|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
708767|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
708768|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
708769|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
708770|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
708771|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
708772|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
708773|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
708774|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
708775|NCT00231777|E2|Reported Event|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
708776|NCT00231777|E1|Reported Event|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
708777|NCT00231478|B3|Baseline|Total|Total of all reporting groups
708778|NCT00231478|B2|Baseline|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
708779|NCT00231478|B1|Baseline|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
708780|NCT00231478|P2|Participant Flow|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
708781|NCT00231478|P1|Participant Flow|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
708782|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
708783|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
708784|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
708785|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
708786|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
708787|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
708788|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
708789|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
708790|NCT00231478|E2|Reported Event|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
708791|NCT00231478|E1|Reported Event|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
708792|NCT00231465|B1|Baseline|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
708793|NCT00231465|P1|Participant Flow|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).
708794|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
708795|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
708796|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
708797|NCT00231465|E1|Reported Event|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
708798|NCT00231309|B1|Baseline|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
708799|NCT00231309|P1|Participant Flow|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
708800|NCT00231309|O1|Outcome|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
708801|NCT00231309|O1|Outcome|Granulocyte-stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
708802|NCT00231309|E1|Reported Event|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
708803|NCT00231283|B1|Baseline|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
708804|NCT00231283|P1|Participant Flow|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
708805|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
708806|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
708807|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
708808|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
708809|NCT00231283|E1|Reported Event|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
708810|NCT00231179|B3|Baseline|Total|Total of all reporting groups
708811|NCT00231179|B2|Baseline|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708812|NCT00231179|B1|Baseline|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
708813|NCT00231179|P2|Participant Flow|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708814|NCT00231179|P1|Participant Flow|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
708815|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708816|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
708817|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708818|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
708819|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708820|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
709315|NCT00227903|O1|Outcome|Brief Advice|Advice and education
708821|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708822|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
708823|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708824|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
708825|NCT00231179|E2|Reported Event|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
708826|NCT00231179|E1|Reported Event|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
708827|NCT00231153|B3|Baseline|Total|Total of all reporting groups
708828|NCT00231153|B2|Baseline|Povidone-Iodine|
708829|NCT00231153|B1|Baseline|Omiganan 1% Gel|
708830|NCT00231153|P2|Participant Flow|Povidone-Iodine|"All treated patients: Properly consented patients who received 1 or more doses of Povidone-Iodine with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
708831|NCT00231153|P1|Participant Flow|Omiganan 1% Gel|"All treated patients: Properly consented patients who received 1 or more doses of omiganan 1% gel with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
708832|NCT00231153|O2|Outcome|Povidone-Iodine|
708833|NCT00231153|O1|Outcome|Omiganan 1% Gel|
708834|NCT00231153|O2|Outcome|Povidone-Iodine|
708835|NCT00231153|O1|Outcome|Omiganan 1% Gel|
708836|NCT00231153|O2|Outcome|Povidone-Iodine|
708837|NCT00231153|O1|Outcome|Omiganan 1% Gel|
708838|NCT00231114|B3|Baseline|Total|Total of all reporting groups
708839|NCT00231114|B2|Baseline|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708840|NCT00231114|B1|Baseline|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708841|NCT00231114|P2|Participant Flow|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708842|NCT00231114|P1|Participant Flow|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708843|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708844|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708845|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708846|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708847|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708848|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708849|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708850|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708851|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708852|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708853|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708854|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708855|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708856|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708857|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708858|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708859|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708860|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708861|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708867|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708868|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708869|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708870|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708871|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708872|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
708873|NCT00231114|E4|Reported Event|Sham (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
708874|NCT00231114|E3|Reported Event|Alair (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System.
708875|NCT00231114|E2|Reported Event|Sham (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment.
708876|NCT00231114|E1|Reported Event|Alair (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System.
708877|NCT00231062|B1|Baseline|Balloon Dilation of Sinus Ostia|
708878|NCT00231062|P1|Participant Flow|Balloon Dilation of Sinus Ostia|
708879|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
708880|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
708881|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
708882|NCT00231062|E1|Reported Event|Balloon Dilation of Sinus Ostia|
708883|NCT00230971|B3|Baseline|Total|Total of all reporting groups
708884|NCT00230971|B2|Baseline|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
708885|NCT00230971|B1|Baseline|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
708886|NCT00230971|P2|Participant Flow|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
708887|NCT00230971|P1|Participant Flow|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
708888|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
708889|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
708890|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
708891|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
708892|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
708893|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
708894|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
708895|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
708896|NCT00230971|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
708897|NCT00230971|E1|Reported Event|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
708898|NCT00230802|B3|Baseline|Total|Total of all reporting groups
708899|NCT00230802|B2|Baseline|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
708900|NCT00230802|B1|Baseline|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
708901|NCT00230802|P2|Participant Flow|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
708902|NCT00230802|P1|Participant Flow|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
708903|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
708904|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
708905|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
708906|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
708907|NCT00230802|O2|Outcome|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
708908|NCT00230802|O1|Outcome|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
708909|NCT00230802|E2|Reported Event|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
708910|NCT00230802|E1|Reported Event|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
708911|NCT00230737|B4|Baseline|Total|Total of all reporting groups
708912|NCT00230737|B3|Baseline|C: Control|Placebo
708913|NCT00230737|B2|Baseline|B: High Dose|Melatonin 4.0 mg
708914|NCT00230737|B1|Baseline|A: Low Dose|Melatonin 0.4 mg
708915|NCT00230737|P3|Participant Flow|C: Control|Placebo
708916|NCT00230737|P2|Participant Flow|B: High Dose|Melatonin 4.0 mg
708917|NCT00230737|P1|Participant Flow|A: Low Dose|Melatonin 0.4 mg
708918|NCT00230737|O3|Outcome|C: Control|Placebo
708919|NCT00230737|O2|Outcome|B: High Dose|Melatonin 4.0 mg
708920|NCT00230737|O1|Outcome|A: Low Dose|Melatonin 0.4 mg
708921|NCT00230737|E3|Reported Event|C: Control|Placebo
708922|NCT00230737|E2|Reported Event|B: High Dose|Melatonin 4.0 mg
708923|NCT00230737|E1|Reported Event|A: Low Dose|Melatonin 0.4 mg
708924|NCT00230282|B1|Baseline|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
708925|NCT00230282|P1|Participant Flow|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
708926|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
708927|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
708928|NCT00230282|E1|Reported Event|Fludarabine, Cytoxan, Then Alemtuzumab|"Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.~Alemtuzumab: 3 to 30 mg, IV~Fludarabine: [(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl]methoxyphosphonic acid~Cytoxan: (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide"
708929|NCT00230178|B4|Baseline|Total|Total of all reporting groups
708930|NCT00230178|B3|Baseline|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
708931|NCT00230178|B2|Baseline|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
708932|NCT00230178|B1|Baseline|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
708933|NCT00230178|P3|Participant Flow|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
708934|NCT00230178|P2|Participant Flow|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
708935|NCT00230178|P1|Participant Flow|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
708936|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
708937|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
708938|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
708939|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
708940|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
708941|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
708942|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
708943|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
708944|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
708945|NCT00230178|E3|Reported Event|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
708946|NCT00230178|E2|Reported Event|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
708947|NCT00230178|E1|Reported Event|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
708948|NCT00230126|B3|Baseline|Total|Total of all reporting groups
708949|NCT00230126|B2|Baseline|Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708988|NCT00230048|P1|Participant Flow|Assessment Only|This arm answered questions only, but received no intervention.
708950|NCT00230126|B1|Baseline|Arm A: 150 mg/Day|"150 mg/day~erlotinib: Arm A: 150 mg/day Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708951|NCT00230126|P2|Participant Flow|Arm B: Erlotinib 150 to 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708952|NCT00230126|P1|Participant Flow|Arm A: Erlotinib 150 mg/Day|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708953|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708954|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708955|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708956|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708957|NCT00230126|O2|Outcome|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708958|NCT00230126|O1|Outcome|Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3.|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708959|NCT00230126|E2|Reported Event|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708960|NCT00230126|E1|Reported Event|Arm A: 150 mg/Day Cycles 1 - 3|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
708961|NCT00230100|B3|Baseline|Total|Total of all reporting groups
708962|NCT00230100|B2|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708963|NCT00230100|B1|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708964|NCT00230100|P2|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708965|NCT00230100|P1|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708966|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708967|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708968|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708969|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708970|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708971|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708972|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708973|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708974|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708989|NCT00230048|O2|Outcome|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
708990|NCT00230048|O1|Outcome|Assessment Only|This arm answered questions only, but received no intervention.
708991|NCT00230048|O2|Outcome|Brief Intervention|Assessment plus 20-minute interactive session with computer, designed to be maximally similar to a therapist-delivered motivational session.
708992|NCT00230048|O1|Outcome|Assessment Only|Assessment only, via computer.
709870|NCT00224016|E2|Reported Event|Oral Oxybutynin|Oxybutynin tablets
708975|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708976|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708977|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708978|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708979|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708980|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
708981|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
708982|NCT00230100|E2|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance dependence; 3) increase patients’ self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
708983|NCT00230100|E1|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
708984|NCT00230048|B3|Baseline|Total|Total of all reporting groups
708985|NCT00230048|B2|Baseline|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
708986|NCT00230048|B1|Baseline|Assessment Only|This arm answered questions only, but received no intervention.
708987|NCT00230048|P2|Participant Flow|Brief Intervention|Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.
708993|NCT00230048|E2|Reported Event|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
708994|NCT00230048|E1|Reported Event|Assessment Only|This arm answered questions only, but received no intervention.
708995|NCT00230022|B3|Baseline|Total|Total of all reporting groups
708996|NCT00230022|B2|Baseline|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
708997|NCT00230022|B1|Baseline|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
708998|NCT00230022|P2|Participant Flow|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
708999|NCT00230022|P1|Participant Flow|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
709000|NCT00230022|O2|Outcome|Assessment Only|Only assessment measures with no subsequent intervention.
709001|NCT00230022|O1|Outcome|Brief Computer-delivered Motivational Intervention|A brief assessment, plus a brief (20-minute) motivational intervention delivered solely by computer. The software was synchronously interactive and followed a traditional motivational interviewing approach.
709002|NCT00230022|E2|Reported Event|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
709003|NCT00230022|E1|Reported Event|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
709004|NCT00230009|B3|Baseline|Total|Total of all reporting groups
709005|NCT00230009|B2|Baseline|Brief Intervention Session|
709006|NCT00230009|B1|Baseline|Assessment Only|
709007|NCT00230009|P2|Participant Flow|Brief Intervention Session|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data. Plus brief therapist-delivered motivational intervention, which was tied to the results of the A-CASI assessment (results from which were viewable immediately by the therapist).
709008|NCT00230009|P1|Participant Flow|Assessment Only|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data only.
709009|NCT00230009|O2|Outcome|Brief Intervention Session|
709010|NCT00230009|O1|Outcome|Assessment Only|
709011|NCT00230009|O2|Outcome|Brief Intervention Session|
709012|NCT00230009|O1|Outcome|Assessment Only|
709013|NCT00230009|O2|Outcome|Brief Intervention Session|
709014|NCT00230009|O1|Outcome|Assessment Only|
709015|NCT00230009|O2|Outcome|Brief Intervention Session|
709016|NCT00230009|O1|Outcome|Assessment Only|
709017|NCT00230009|O2|Outcome|Brief Intervention Session|
709018|NCT00230009|O1|Outcome|Assessment Only|
709019|NCT00230009|E2|Reported Event|Brief Intervention Session|
709020|NCT00230009|E1|Reported Event|Assessment Only|
709021|NCT00229970|B4|Baseline|Total|Total of all reporting groups
709022|NCT00229970|B3|Baseline|Placebo|Placebo Intravenous Administration
709023|NCT00229970|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
709024|NCT00229970|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
709025|NCT00229970|P3|Participant Flow|Placebo|Placebo Intravenous Administration
709026|NCT00229970|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
709027|NCT00229970|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
709028|NCT00229970|O3|Outcome|Placebo|Placebo Intravenous Administration
709029|NCT00229970|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
709030|NCT00229970|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
709031|NCT00229970|E3|Reported Event|Placebo|Placebo Intravenous Administration
709032|NCT00229970|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
709033|NCT00229970|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
709034|NCT00229957|B3|Baseline|Total|Total of all reporting groups
709035|NCT00229957|B2|Baseline|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
709036|NCT00229957|B1|Baseline|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
709037|NCT00229957|P2|Participant Flow|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
709038|NCT00229957|P1|Participant Flow|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
709039|NCT00229957|O2|Outcome|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
709040|NCT00229957|O1|Outcome|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
709041|NCT00229957|E2|Reported Event|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
709042|NCT00229957|E1|Reported Event|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
709043|NCT00229931|B3|Baseline|Total|Total of all reporting groups
709070|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709044|NCT00229931|B2|Baseline|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
709045|NCT00229931|B1|Baseline|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
709046|NCT00229931|P2|Participant Flow|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
709047|NCT00229931|P1|Participant Flow|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
709048|NCT00229931|O2|Outcome|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
709049|NCT00229931|O1|Outcome|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
709050|NCT00229931|O2|Outcome|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
709051|NCT00229931|O1|Outcome|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
709052|NCT00229931|E2|Reported Event|Triamcinolone Therapy|"At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.~Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response"
709053|NCT00229931|E1|Reported Event|Laser Therapy|"If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.~laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement."
709054|NCT00229723|B8|Baseline|Total|Total of all reporting groups
709055|NCT00229723|B7|Baseline|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709056|NCT00229723|B6|Baseline|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709057|NCT00229723|B5|Baseline|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709058|NCT00229723|B4|Baseline|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709059|NCT00229723|B3|Baseline|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709060|NCT00229723|B2|Baseline|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709061|NCT00229723|B1|Baseline|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709062|NCT00229723|P7|Participant Flow|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709063|NCT00229723|P6|Participant Flow|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709064|NCT00229723|P5|Participant Flow|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709065|NCT00229723|P4|Participant Flow|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709066|NCT00229723|P3|Participant Flow|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709067|NCT00229723|P2|Participant Flow|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709068|NCT00229723|P1|Participant Flow|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709069|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709253|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709071|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709072|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709073|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709074|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709075|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709076|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709077|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709078|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709079|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709080|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709081|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709082|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709083|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709084|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709085|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709086|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709087|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709088|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709089|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709090|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709091|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709092|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709093|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709094|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709095|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709096|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709097|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709098|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709099|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709100|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709101|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709102|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709103|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709104|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709105|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709106|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709107|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709108|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709109|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709110|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709111|NCT00229723|E7|Reported Event|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709112|NCT00229723|E6|Reported Event|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709113|NCT00229723|E5|Reported Event|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
709114|NCT00229723|E4|Reported Event|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
709316|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709115|NCT00229723|E3|Reported Event|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709116|NCT00229723|E2|Reported Event|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709117|NCT00229723|E1|Reported Event|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
709118|NCT00229658|B3|Baseline|Total|Total of all reporting groups
709119|NCT00229658|B2|Baseline|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709120|NCT00229658|B1|Baseline|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709121|NCT00229658|P2|Participant Flow|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709122|NCT00229658|P1|Participant Flow|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709123|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709124|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709125|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709126|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709127|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709128|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709129|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709130|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709131|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709132|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709133|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709134|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709135|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709136|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709137|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709138|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709139|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709140|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709141|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709142|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709143|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709144|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709145|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709146|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709147|NCT00229658|E2|Reported Event|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
709148|NCT00229658|E1|Reported Event|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
709149|NCT00229619|B1|Baseline|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
709150|NCT00229619|P1|Participant Flow|Rituximab Treated Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
709151|NCT00229619|O1|Outcome|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
709152|NCT00229619|E1|Reported Event|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
709153|NCT00229203|B3|Baseline|Total|Total of all reporting groups
709154|NCT00229203|B2|Baseline|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
709155|NCT00229203|B1|Baseline|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
709156|NCT00229203|P2|Participant Flow|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
709157|NCT00229203|P1|Participant Flow|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
709158|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
709159|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
709160|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
709161|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
709254|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709162|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
709163|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
709164|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
709165|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
709166|NCT00229203|E2|Reported Event|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
709167|NCT00229203|E1|Reported Event|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
709168|NCT00228943|B1|Baseline|Entire Sample|"Consented subjects in the entire sample were randomized to one of two groups for the cross-over design study. One group of subjects received a full-strength tryptophan depletion drink during week 1 followed by a half-strength (control) drink week 2. The other group of subjects received a half-strength tryptophan depletion (control) drink during week 1 followed by a full-strength drink week 2.~The final analysis combined groups to compare full strength versus control."
709169|NCT00228943|P1|Participant Flow|Full Strength Acute Tryptophan Depletion and Control|Subjects were randomized to receive both a full-strength acute tryptophan depletion drink and half-strength tryptophan depletion drink (control). Some participants received the full-strength drink first for week 1 and then crossed-over to the half-strength (control) drink for week 2; the other participants received the half-strength (control) drink for week 1 and then crossed over to the full-strength drink for week 2.
709170|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
709171|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
709172|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
709173|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
709174|NCT00228943|E2|Reported Event|Half-Strength Tryptophan Depletion - Control|No adverse events
709175|NCT00228943|E1|Reported Event|Full Strength Acute Tryptophan Depletion|No adverse events
709176|NCT00228917|B5|Baseline|Total|Total of all reporting groups
709177|NCT00228917|B4|Baseline|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709178|NCT00228917|B3|Baseline|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709179|NCT00228917|B2|Baseline|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709180|NCT00228917|B1|Baseline|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
709181|NCT00228917|P4|Participant Flow|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709182|NCT00228917|P3|Participant Flow|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709183|NCT00228917|P2|Participant Flow|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709184|NCT00228917|P1|Participant Flow|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
709185|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709186|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709187|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709188|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
709189|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709190|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709191|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709192|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
709193|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709194|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709195|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709196|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
709197|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709255|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709198|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709199|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709200|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
709201|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709202|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709203|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709204|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
709205|NCT00228917|E4|Reported Event|TRITANRIX-HEPB/ TRITANRIX-HEPB GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709206|NCT00228917|E3|Reported Event|TRITANRIX-HEPB/ HIBERIX GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709207|NCT00228917|E2|Reported Event|HIBERIX/TRITANRIX-HEPB GROUP|Subjects vaccinated with 3 doses of Mencevax™ ACW vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709208|NCT00228917|E1|Reported Event|HIBERIX/ HIBERIX GROUP|Subjects vaccinated with 3 doses of Mencevax™ ACW vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
709209|NCT00228813|B1|Baseline|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
709210|NCT00228813|P1|Participant Flow|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
709211|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
709311|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709212|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
709213|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
709214|NCT00228813|E1|Reported Event|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
709215|NCT00228566|B1|Baseline|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
709216|NCT00228566|P1|Participant Flow|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
709217|NCT00228566|O1|Outcome|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
709218|NCT00228566|E1|Reported Event|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
709219|NCT00228553|B1|Baseline|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
709220|NCT00228553|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
709221|NCT00228553|O1|Outcome|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
709222|NCT00228553|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
709223|NCT00228384|B3|Baseline|Total|Total of all reporting groups
709224|NCT00228384|B2|Baseline|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709225|NCT00228384|B1|Baseline|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709226|NCT00228384|P2|Participant Flow|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709227|NCT00228384|P1|Participant Flow|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709228|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709229|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709230|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709231|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709232|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709233|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709234|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709235|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709236|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709237|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709238|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709239|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709240|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709241|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709242|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709243|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709244|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709245|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709246|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709247|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709248|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709249|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709250|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709251|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709252|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709256|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709257|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709258|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709259|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709260|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
709261|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
709262|NCT00228384|E2|Reported Event|Bare Nitinol Stent|Bare Nitinol Stent
709263|NCT00228384|E1|Reported Event|GORE VIABAHN Endoprosthesis|GORE VIABAHN Endoprosthesis
709264|NCT00227994|B3|Baseline|Total|Total of all reporting groups
709265|NCT00227994|B2|Baseline|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
709266|NCT00227994|B1|Baseline|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
709267|NCT00227994|P2|Participant Flow|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
709268|NCT00227994|P1|Participant Flow|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
709269|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
709270|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
709271|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
709272|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
709273|NCT00227994|E2|Reported Event|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
709274|NCT00227994|E1|Reported Event|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
709275|NCT00227903|B3|Baseline|Total|Total of all reporting groups
709276|NCT00227903|B2|Baseline|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709277|NCT00227903|B1|Baseline|Brief Advice|Advice and education
709278|NCT00227903|P2|Participant Flow|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709279|NCT00227903|P1|Participant Flow|Brief Advice|Advice and education
709280|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709281|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709282|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709283|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709284|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709285|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709286|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709287|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709288|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709289|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709290|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709291|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709292|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709293|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709294|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709295|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709296|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709297|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709298|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709299|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709300|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709301|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709302|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709303|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709304|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709305|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709306|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709307|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709308|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709309|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709310|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709318|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709319|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709320|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709321|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709322|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709323|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709324|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709325|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709326|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709327|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709328|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709329|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709330|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709331|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709332|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709333|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709334|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709335|NCT00227903|O1|Outcome|Brief Advice|Advice and education
709336|NCT00227903|E2|Reported Event|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
709337|NCT00227903|E1|Reported Event|Brief Advice|Advice and education
709338|NCT00227760|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
709339|NCT00227760|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
709340|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
709341|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
709342|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
709343|NCT00227760|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
709344|NCT00227721|B1|Baseline|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
709345|NCT00227721|P1|Participant Flow|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
709346|NCT00227721|O1|Outcome|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
709347|NCT00227721|E1|Reported Event|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
709348|NCT00227591|B1|Baseline|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
709349|NCT00227591|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
709350|NCT00227591|O1|Outcome|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
709351|NCT00227591|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
709352|NCT00227539|B1|Baseline|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
709353|NCT00227539|P1|Participant Flow|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
709354|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
709355|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
709402|NCT00227305|B1|Baseline|Quetiapine|Quetiapine 400mg/day to 800mg/day
709356|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
709357|NCT00227539|E1|Reported Event|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
709358|NCT00227370|B3|Baseline|Total|Total of all reporting groups
709359|NCT00227370|B2|Baseline|Treatment Group|Upon randomisation at 3 months, patients remained on Valganciclovir for 9 additional months.
709360|NCT00227370|B1|Baseline|Placebo Group|Upon randomisation at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis
709361|NCT00227370|P2|Participant Flow|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709362|NCT00227370|P1|Participant Flow|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis). 3 months of Valganciclovir was the standard of care for CMV prevention at the time of study initiation. This was the prespecified placebo group/intervention arm.
709363|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709364|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709365|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709366|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709367|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709368|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709369|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709370|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709371|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709372|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709373|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709374|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709375|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709376|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709377|NCT00227370|E2|Reported Event|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
709378|NCT00227370|E1|Reported Event|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
709379|NCT00227344|B3|Baseline|Total|Total of all reporting groups
709380|NCT00227344|B2|Baseline|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709381|NCT00227344|B1|Baseline|Catheter Ablation|Catheter Ablation
709382|NCT00227344|P2|Participant Flow|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709383|NCT00227344|P1|Participant Flow|Catheter Ablation|Catheter Ablation
709384|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709385|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709386|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709387|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709388|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709389|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709390|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709391|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709392|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709393|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709394|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709395|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709396|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709397|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709398|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709399|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
709400|NCT00227344|E2|Reported Event|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
709401|NCT00227344|E1|Reported Event|Catheter Ablation|Catheter Ablation
710377|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
709403|NCT00227305|P1|Participant Flow|Quetiapine|Quetiapine 400mg/day to 800mg/day
709404|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709405|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709406|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709407|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709408|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709409|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709410|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709411|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709412|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709413|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709414|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
709415|NCT00227305|E1|Reported Event|Quetiapine|Quetiapine 400mg/day to 800mg/day
709416|NCT00227266|B4|Baseline|Total|Total of all reporting groups
709417|NCT00227266|B3|Baseline|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709418|NCT00227266|B2|Baseline|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709419|NCT00227266|B1|Baseline|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
709420|NCT00227266|P3|Participant Flow|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709421|NCT00227266|P2|Participant Flow|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709422|NCT00227266|P1|Participant Flow|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
709423|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709424|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709425|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
709426|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709427|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709428|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
709429|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|
709430|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|
709614|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
709431|NCT00227266|O1|Outcome|Cohort 2 Experimental|"Patients in cohort 2 (SMA standers and walkers) will receive VPA + Carnitine treatment for the entire 12 month time period."
709432|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709433|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709434|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
709435|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709436|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709437|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
709438|NCT00227266|E3|Reported Event|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709439|NCT00227266|E2|Reported Event|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
709440|NCT00227266|E1|Reported Event|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
709441|NCT00227019|B1|Baseline|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
709442|NCT00227019|P1|Participant Flow|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
709443|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
709444|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
709445|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
709446|NCT00227019|E1|Reported Event|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
709447|NCT00226941|B5|Baseline|Total|Total of all reporting groups
709448|NCT00226941|B4|Baseline|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709449|NCT00226941|B3|Baseline|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709450|NCT00226941|B2|Baseline|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709528|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
709451|NCT00226941|B1|Baseline|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709452|NCT00226941|P4|Participant Flow|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709453|NCT00226941|P3|Participant Flow|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709454|NCT00226941|P2|Participant Flow|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85mg/m², Days 2 and 23"
709455|NCT00226941|P1|Participant Flow|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709456|NCT00226941|O4|Outcome|Group B - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709457|NCT00226941|O3|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709458|NCT00226941|O2|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 850 mg/m², Days 2 and 23"
709459|NCT00226941|O1|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709460|NCT00226941|O4|Outcome|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709461|NCT00226941|O3|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709462|NCT00226941|O2|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709463|NCT00226941|O1|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709464|NCT00226941|O4|Outcome|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709465|NCT00226941|O3|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709466|NCT00226941|O2|Outcome|Group 2 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709467|NCT00226941|O1|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709468|NCT00226941|O4|Outcome|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709469|NCT00226941|O3|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709470|NCT00226941|O2|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709471|NCT00226941|O1|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709472|NCT00226941|O4|Outcome|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709473|NCT00226941|O3|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709474|NCT00226941|O2|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709475|NCT00226941|O1|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709476|NCT00226941|O4|Outcome|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709477|NCT00226941|O3|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709478|NCT00226941|O2|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85mg/m², Days 2 and 23"
709479|NCT00226941|O1|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709480|NCT00226941|O4|Outcome|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709481|NCT00226941|O3|Outcome|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709482|NCT00226941|O2|Outcome|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709483|NCT00226941|O1|Outcome|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709484|NCT00226941|E4|Reported Event|Group B - Cetuximab + Capecitabine-1000 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 1000 mg/m²~Radiotherapy (XRT)"
709485|NCT00226941|E3|Reported Event|Group A - Cetuximab + Capecitabine-800 + XRT|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)"
709486|NCT00226941|E2|Reported Event|Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85|"Cetuximab 250 mg/m² / week~Capecitabine 700 mg/m²~Radiotherapy (XRT)~Oxaliplatin 85 mg/m², Days 2 and 23"
709487|NCT00226941|E1|Reported Event|Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100|"Cetuximab 250 mg/m² / week~Capecitabine 800 mg/m²~Radiotherapy (XRT)~Oxaliplatin 100 mg/m², Days 2 and 23"
709488|NCT00226811|B1|Baseline|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709489|NCT00226811|P1|Participant Flow|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709490|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709491|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709492|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709493|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709494|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709495|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709496|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709497|NCT00226811|E1|Reported Event|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
709498|NCT00226655|B1|Baseline|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
709499|NCT00226655|P1|Participant Flow|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
709500|NCT00226655|O1|Outcome|hCRF|hCRF administered 1mg bid subcutaneously
709501|NCT00226655|E1|Reported Event|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
709502|NCT00226590|B1|Baseline|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
709503|NCT00226590|P1|Participant Flow|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
709504|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
709505|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
709506|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
709507|NCT00226590|O1|Outcome|Induction Therapy|Tolerance of Induction Therapy prior to Chemoradiation
709508|NCT00226590|E1|Reported Event|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
709509|NCT00226577|B1|Baseline|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709510|NCT00226577|P1|Participant Flow|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709529|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
709863|NCT00224016|B1|Baseline|Oxybutynin TDS|Oxybutynin Transdermal System
709511|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709512|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709513|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709514|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709515|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709516|NCT00226577|E1|Reported Event|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
709517|NCT00226239|B1|Baseline|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709518|NCT00226239|P1|Participant Flow|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709519|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709520|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709521|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709522|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709523|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709524|NCT00226239|O1|Outcome|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles
709525|NCT00226239|E1|Reported Event|Head and Neck Cancer Patients|Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
709526|NCT00225784|B1|Baseline|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
709527|NCT00225784|P1|Participant Flow|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
709530|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
709531|NCT00225784|O2|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
709532|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (-) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR negative tumors.
709533|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
709534|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
709535|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.
709536|NCT00225784|E1|Reported Event|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
709537|NCT00225732|B3|Baseline|Total|Total of all reporting groups
709538|NCT00225732|B2|Baseline|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709539|NCT00225732|B1|Baseline|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709540|NCT00225732|P2|Participant Flow|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709541|NCT00225732|P1|Participant Flow|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709542|NCT00225732|O2|Outcome|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709543|NCT00225732|O1|Outcome|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709544|NCT00225732|E2|Reported Event|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709569|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709570|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709571|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709545|NCT00225732|E1|Reported Event|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
709546|NCT00225498|B1|Baseline|All Participants|Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.
709547|NCT00225498|P1|Participant Flow|Ziprasidone|ziprasidone target dose is 160 mg/day
709548|NCT00225498|O1|Outcome|Ziprasidone|ziprasidone target dose is 160 mg/day
709549|NCT00225498|E1|Reported Event|Ziprasidone|
709550|NCT00225420|B1|Baseline|Overall Study|"Single Arm Docetaxel: Docetaxel will be administered per the designated cohort starting at 10, 15 or 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
709551|NCT00225420|P3|Participant Flow|Docetaxel 20 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
709552|NCT00225420|P2|Participant Flow|Docetaxel 15 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
709553|NCT00225420|P1|Participant Flow|Docetaxel 10 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 centigray (cGy) in 200 cGy per fraction for a total of 39 treatments."
709554|NCT00225420|O1|Outcome|Single Arm|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
709555|NCT00225420|O3|Outcome|Docetaxel 20 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
709556|NCT00225420|O2|Outcome|Docetaxel 15 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
709557|NCT00225420|O1|Outcome|Docetaxel at 10 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
709558|NCT00225420|E1|Reported Event|Single Arm|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
709559|NCT00225277|B3|Baseline|Total|Total of all reporting groups
709560|NCT00225277|B2|Baseline|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709561|NCT00225277|B1|Baseline|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709562|NCT00225277|P2|Participant Flow|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709563|NCT00225277|P1|Participant Flow|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709564|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709565|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709566|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709567|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709568|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709572|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709573|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709574|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709575|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709576|NCT00225277|E2|Reported Event|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
709577|NCT00225277|E1|Reported Event|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
709578|NCT00225251|B3|Baseline|Total|Total of all reporting groups
709579|NCT00225251|B2|Baseline|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709580|NCT00225251|B1|Baseline|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709581|NCT00225251|P2|Participant Flow|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709582|NCT00225251|P1|Participant Flow|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709583|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709584|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709585|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709586|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709587|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709588|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709589|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709590|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709591|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709592|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709593|NCT00225251|E2|Reported Event|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
709594|NCT00225251|E1|Reported Event|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
709595|NCT00225212|B1|Baseline|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
709596|NCT00225212|P1|Participant Flow|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
709597|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
709598|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
709599|NCT00225212|E1|Reported Event|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
709600|NCT00225147|B5|Baseline|Total|Total of all reporting groups
709601|NCT00225147|B4|Baseline|"50 IU/kg Open-label rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT)analysis population, which included all subjects who received 50 IU/kg open-label rhC1INH."
709602|NCT00225147|B3|Baseline|Placebo|"Baseline characteristics were calculated for the modified intention to treat (mITT) analysis population, which included all subjects randomized to the placebo arm."
709603|NCT00225147|B2|Baseline|"50 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included subjects who received 50 IU/kg rhC1INH. One (1) subject was randomized to the 50 IU/kg rhC1INH arm, but did not receive study drug administration and was excluded from the mITT analysis population."
709604|NCT00225147|B1|Baseline|"100 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included all subjects who received 100 IU/kg rhC1INH."
709605|NCT00225147|P4|Participant Flow|"50 IU/kg Open-label rhC1INH"|"Includes all subjects treated with 50 IU/kg open-label rhC1INH in the open-label phase."
709606|NCT00225147|P3|Participant Flow|Placebo|Includes all subjects randomized and treated with Placebo in the double-blind phase
709607|NCT00225147|P2|Participant Flow|"50 IU/kg rhC1INH"|Includes all subjects randomized and treated with 50 IU/kg Recombinant human C1 inhibitor in the double-blind phase
709608|NCT00225147|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and treated with 100 IU/kg Recombinant human C1 inhibitor in the double-blind phase
709609|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
709610|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
709611|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg Recombinant human C1 inhibitor arm
709612|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg Recombinant human C1 inhibitor arm
709613|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
709615|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg body weight recombinant human C1 Inhibitor arm
709616|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg body weight recombinant human C1 Inhibitor arm
709617|NCT00225147|E4|Reported Event|"50 IU/kg Open-label rhC1INH"|"Includes all subjects receiving 50 IU/kg open-label recombinant human C1 inhibitor and subjects receiving an additional dose of 50 IU/kg rhC1INH within 4 hours after initial administration."
709618|NCT00225147|E3|Reported Event|Placebo|Includes all subjects receiving Saline solution
709619|NCT00225147|E2|Reported Event|50 IU/kg rhC1INH|Includes all subjects receiving 50 IU/kg Recombinant human C1 inhibitor
709620|NCT00225147|E1|Reported Event|100 IU/kg rhC1INH|Includes all subjects receiving 100 IU/kg Recombinant human C1 inhibitor
709621|NCT00225017|B3|Baseline|Total|Total of all reporting groups
709622|NCT00225017|B2|Baseline|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
709623|NCT00225017|B1|Baseline|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
709624|NCT00225017|P2|Participant Flow|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
709625|NCT00225017|P1|Participant Flow|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
709626|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
709627|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
709628|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
709629|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
709630|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
709631|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
709632|NCT00225017|E2|Reported Event|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
709633|NCT00225017|E1|Reported Event|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
709634|NCT00224952|B4|Baseline|Total|Total of all reporting groups
709635|NCT00224952|B3|Baseline|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
709636|NCT00224952|B2|Baseline|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709637|NCT00224952|B1|Baseline|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709638|NCT00224952|P3|Participant Flow|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
709639|NCT00224952|P2|Participant Flow|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709640|NCT00224952|P1|Participant Flow|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709641|NCT00224952|O3|Outcome|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
709642|NCT00224952|O2|Outcome|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709643|NCT00224952|O1|Outcome|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709644|NCT00224952|O3|Outcome|Valproic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
709645|NCT00224952|O2|Outcome|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709646|NCT00224952|O1|Outcome|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709647|NCT00224952|E3|Reported Event|Valporic Acid Phase 2|No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management
709648|NCT00224952|E2|Reported Event|Carbamazepine Phase 2|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709864|NCT00224016|P2|Participant Flow|Oral Oxybutynin|Oxybutynin tablets
709649|NCT00224952|E1|Reported Event|Carbamazepine Phase 1|No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management
709650|NCT00224874|B5|Baseline|Total|Total of all reporting groups
709651|NCT00224874|B4|Baseline|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709652|NCT00224874|B3|Baseline|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709653|NCT00224874|B2|Baseline|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709654|NCT00224874|B1|Baseline|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709655|NCT00224874|P4|Participant Flow|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709656|NCT00224874|P3|Participant Flow|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709657|NCT00224874|P2|Participant Flow|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709658|NCT00224874|P1|Participant Flow|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709659|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709660|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709661|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709662|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709663|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709664|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709665|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709666|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709667|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709668|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709669|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709670|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709671|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709672|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709673|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709674|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709675|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709676|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709677|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709678|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709679|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709680|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709681|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709682|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709683|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709684|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709685|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709686|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709687|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709688|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709865|NCT00224016|P1|Participant Flow|Oxybutynin TDS|Oxybutynin Transdermal System
709866|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
709689|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709690|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709691|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709692|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709693|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709694|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709695|NCT00224874|E4|Reported Event|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
709696|NCT00224874|E3|Reported Event|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
709697|NCT00224874|E2|Reported Event|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
709698|NCT00224874|E1|Reported Event|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
709699|NCT00224770|B4|Baseline|Total|Total of all reporting groups
709700|NCT00224770|B3|Baseline|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709701|NCT00224770|B2|Baseline|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709702|NCT00224770|B1|Baseline|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709703|NCT00224770|P3|Participant Flow|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709704|NCT00224770|P2|Participant Flow|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709705|NCT00224770|P1|Participant Flow|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709706|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709707|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709708|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709709|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709710|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709711|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709712|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709733|NCT00224770|E3|Reported Event|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709867|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
709868|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
709713|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709714|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709715|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709716|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709717|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709718|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709719|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709720|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709721|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting technique as the MISTIE arm. No rt-PA administered, and in addition to best medical care.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709722|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709723|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709724|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709725|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709726|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709727|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709728|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709729|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709730|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
709731|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709732|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709734|NCT00224770|E2|Reported Event|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
709735|NCT00224770|E1|Reported Event|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
709736|NCT00224484|B4|Baseline|Total|Total of all reporting groups
709737|NCT00224484|B3|Baseline|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709738|NCT00224484|B2|Baseline|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709739|NCT00224484|B1|Baseline|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709740|NCT00224484|P3|Participant Flow|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709741|NCT00224484|P2|Participant Flow|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709742|NCT00224484|P1|Participant Flow|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709743|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709744|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709745|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709746|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709747|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
709748|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709749|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
709750|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709751|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
709752|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709753|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709754|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709755|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709756|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709757|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709758|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709759|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709760|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709761|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709762|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709763|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709764|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709765|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709766|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709767|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709768|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709769|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709770|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709771|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709772|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709773|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709774|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709775|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709776|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709777|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709778|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709779|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709780|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709781|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709782|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709783|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709784|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709785|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709786|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709787|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709788|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709789|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709790|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709791|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709792|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709856|NCT00224042|E1|Reported Event|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
709793|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709794|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709795|NCT00224484|E5|Reported Event|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups, included in the Extended Safety Follow Up (ESFU) period.
709796|NCT00224484|E4|Reported Event|GD2-AS04 (ESFU) Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709797|NCT00224484|E3|Reported Event|Group Saline|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709798|NCT00224484|E2|Reported Event|Group Havrix|Female subjects aged 10-17 years, who received 3 doses of Havrix™ vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709799|NCT00224484|E1|Reported Event|Group GD2-AS04|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
709800|NCT00224289|B1|Baseline|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
709801|NCT00224289|P1|Participant Flow|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
709802|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
709803|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
709804|NCT00224289|E1|Reported Event|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
709805|NCT00224133|B1|Baseline|8 mg Silodosin Per Day With Food|
709806|NCT00224133|P1|Participant Flow|8 mg Silodosin Per Day With Food|
709807|NCT00224133|O1|Outcome|8 mg Silodosin Per Day With Food|
709808|NCT00224133|E1|Reported Event|8 mg Silodosin Per Day With Food|
709809|NCT00224120|B3|Baseline|Total|Total of all reporting groups
709810|NCT00224120|B2|Baseline|Placebo|Matching placebo capsule once daily with food
709811|NCT00224120|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
709812|NCT00224120|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
709813|NCT00224120|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
709814|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
709815|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
709816|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
709817|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
709818|NCT00224120|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
709819|NCT00224120|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
709820|NCT00224107|B3|Baseline|Total|Total of all reporting groups
709821|NCT00224107|B2|Baseline|Placebo|Matching placebo capsule once daily with food
709822|NCT00224107|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
709823|NCT00224107|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
709824|NCT00224107|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
709825|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
709826|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
709827|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
709828|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
709829|NCT00224107|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
709830|NCT00224107|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
709831|NCT00224055|B3|Baseline|Total|Total of all reporting groups
709832|NCT00224055|B2|Baseline|Oral Iron|
709833|NCT00224055|B1|Baseline|IV Iron|
709834|NCT00224055|P2|Participant Flow|Oral Iron|
709835|NCT00224055|P1|Participant Flow|IV Iron|
709836|NCT00224055|O2|Outcome|Oral Iron|
709837|NCT00224055|O1|Outcome|IV Iron|
709838|NCT00224055|O2|Outcome|Oral Iron|
709839|NCT00224055|O1|Outcome|IV Iron|
709840|NCT00224055|E2|Reported Event|Oral Iron|
709841|NCT00224055|E1|Reported Event|IV Iron|
709842|NCT00224042|B3|Baseline|Total|Total of all reporting groups
709843|NCT00224042|B2|Baseline|Oral Iron|
709844|NCT00224042|B1|Baseline|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
709845|NCT00224042|P2|Participant Flow|Oral Iron|
709846|NCT00224042|P1|Participant Flow|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
709847|NCT00224042|O2|Outcome|Oral Iron|
709848|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
709849|NCT00224042|O2|Outcome|Oral Iron|
709850|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
709851|NCT00224042|O2|Outcome|Oral Iron|
709852|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
709853|NCT00224042|O2|Outcome|Oral Iron|
709854|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
709855|NCT00224042|E2|Reported Event|Oral Iron|
709871|NCT00224016|E1|Reported Event|Oxybutynin TDS|Oxybutynin Transdermal System
709872|NCT00224003|B1|Baseline|Sodium Ferric Gluconate Complex|
709873|NCT00224003|P1|Participant Flow|Sodium Ferric Gluconate Complex|
709874|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
709875|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
709876|NCT00223977|B4|Baseline|Total|Total of all reporting groups
709877|NCT00223977|B3|Baseline|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709878|NCT00223977|B2|Baseline|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709879|NCT00223977|B1|Baseline|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709880|NCT00223977|P3|Participant Flow|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709881|NCT00223977|P2|Participant Flow|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709882|NCT00223977|P1|Participant Flow|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709883|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709884|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709885|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709886|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709887|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709888|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709889|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709890|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709891|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709892|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709893|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709894|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709895|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709896|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709897|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709898|NCT00223977|E3|Reported Event|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
709899|NCT00223977|E2|Reported Event|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
709900|NCT00223977|E1|Reported Event|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
709901|NCT00223821|B3|Baseline|Total|Total of all reporting groups
709902|NCT00223821|B2|Baseline|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
709903|NCT00223821|B1|Baseline|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
709904|NCT00223821|P2|Participant Flow|Drug Therapy + Behavioral Training|"drug therapy + behavioral training~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.~Behavior Training: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
709905|NCT00223821|P1|Participant Flow|Drug Therapy Alone|"drug therapy alone~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects."
709906|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
709907|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
709908|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
709909|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
709910|NCT00223821|E2|Reported Event|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
709911|NCT00223821|E1|Reported Event|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
709912|NCT00223808|B4|Baseline|Total|Total of all reporting groups
709913|NCT00223808|B3|Baseline|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
709914|NCT00223808|B2|Baseline|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
709915|NCT00223808|B1|Baseline|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
709916|NCT00223808|P3|Participant Flow|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
710378|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
709917|NCT00223808|P2|Participant Flow|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
709918|NCT00223808|P1|Participant Flow|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
709919|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
709920|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
709921|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
709922|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
709923|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
709924|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
709925|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
709926|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
709927|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
709928|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
709929|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
709930|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
709931|NCT00223808|E3|Reported Event|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
709932|NCT00223808|E2|Reported Event|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
709933|NCT00223808|E1|Reported Event|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
709934|NCT00223795|B1|Baseline|Baseline Characteristics All Subjects|Community-dwelling patients with unilateral knee pain on movement which they scored at >35 mm on a 100-mm visual analogue scale (VAS) for most days of the previous month. Other inclusion criteria included having a weight less than 300 pounds, no cane use for the past 30 days, fulfillment of the American College of Rheumatology criteria for knee OA , and radiographic Kellgren-Lawrence scale knee OA grade > 1. We excluded individuals who had knee trauma or surgery, including arthroscopic surgery, within the past six months, upper body weakness, injury or amputation to the lower extremity joints, symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee, poor health that would impair compliance or assessment such as shortness of breath with exertion, or neurological disease including vestibular dysfunction, or impaired vision.
709935|NCT00223795|P2|Participant Flow|Arm 2 - Cane|Single point cane first, then continue with single point cane
709936|NCT00223795|P1|Participant Flow|Arm 1 - Control/Crossover|No cane first, then single point cane
709937|NCT00223795|O2|Outcome|Arm 2- Cane Users|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants given a cane to use at home during the first intervention period and then for four months after the first intervention period.
709938|NCT00223795|O1|Outcome|Arm 1 - Waiting Control|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants not given a cane to use at home during the intervention period. They were given a cane to use for four months after the first intervention period
709939|NCT00223795|E3|Reported Event|Arm 2- Single Point Cane|single point cane for 8 weeks then single point cane for next 4 months
709940|NCT00223795|E2|Reported Event|Arm 1 - Intervention - Crossover to Cane|Given single point cane to use for 4 months following 8 weeks without a cane
709941|NCT00223795|E1|Reported Event|Arm 1: Intervention - no Cane for First 8 Weeks|No cane for first 8 weeks
709942|NCT00223704|B4|Baseline|Total|Total of all reporting groups
709943|NCT00223704|B3|Baseline|HOE 140 Group|Bradykinin B2 receptor antagonist
709944|NCT00223704|B2|Baseline|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
709945|NCT00223704|B1|Baseline|Placebo Group|Placebo was normal saline
709946|NCT00223704|P3|Participant Flow|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
709947|NCT00223704|P2|Participant Flow|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
710715|NCT00216476|B3|Baseline|Total|Total of all reporting groups
709948|NCT00223704|P1|Participant Flow|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
709949|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
709950|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
709951|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
709952|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
709953|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
709954|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
709955|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
709956|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
709957|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
709958|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
709959|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
709960|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
709961|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
709962|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
709963|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
709964|NCT00223704|E3|Reported Event|HOE 140 Group|Bradykinin B2 receptor antagonist
709965|NCT00223704|E2|Reported Event|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
709966|NCT00223704|E1|Reported Event|Placebo Group|Placebo was normal saline
709967|NCT00223678|B3|Baseline|Total|Total of all reporting groups
709968|NCT00223678|B2|Baseline|CYA/Prograf|Patient will remain on calcineurin inhibitor,CYA/Prograf
709969|NCT00223678|B1|Baseline|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin~Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
709970|NCT00223678|P2|Participant Flow|CYA/Prograf|Patient will remain on calcineurin inhibitor,CYA/Prograf
709971|NCT00223678|P1|Participant Flow|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin~Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
709972|NCT00223678|O2|Outcome|CNI Group|Patient will remain on calcineurin inhibitor with a low target serum levels 50ng/ml to 125ng/mg 12 hour trough
709973|NCT00223678|O1|Outcome|Rapamycin Group|pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin.Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
709974|NCT00223678|E2|Reported Event|CNI Group|
709975|NCT00223678|E1|Reported Event|Rapamycin Group|
710816|NCT00215943|B3|Baseline|Total|Total of all reporting groups
709976|NCT00223665|B1|Baseline|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709977|NCT00223665|P1|Participant Flow|Intermittent Androgen Suppression (IAS)|"Intermittent Androgen Suppression in 9 month cycles:~Flutamide, 250 mg by mouth 3 times daily for a total of two weeks~Leuprolide Acetate, 7.5mg intramuscular injections every 4 weeks for a total of nine months"
709978|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709979|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709980|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709981|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709982|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709983|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709984|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709985|NCT00223665|O1|Outcome|Combined Androgen Blockade|"Intermittent Hormone Therapy using Flutamide and Leuprolide acetate~Flutamide: 250mg three times a day by mouth~Leuprolide Acetate: 7.5mg once a month by intramuscular injection"
709986|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709987|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709988|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709989|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709990|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709991|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709992|NCT00223665|O1|Outcome|Intermittent Androgen Suppression (IAS)|Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
709993|NCT00223665|E1|Reported Event|Combined Androgen Blockade|"Intermittent Hormone Therapy using Flutamide and Leuprolide acetate~Flutamide: 250mg three times a day by mouth~Leuprolide Acetate: 7.5mg once a month by intramuscular injection"
709994|NCT00223652|B3|Baseline|Total|Total of all reporting groups
709995|NCT00223652|B2|Baseline|Treatment as Usual|Treatment as usual control.
709996|NCT00223652|B1|Baseline|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
709997|NCT00223652|P2|Participant Flow|Treatment as Usual|Treatment as usual control.
709998|NCT00223652|P1|Participant Flow|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
709999|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
710000|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
710001|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
710002|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
710003|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
710004|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
710005|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
710037|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
714098|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
710006|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
710007|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
710008|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
710009|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
710010|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
710011|NCT00223652|E2|Reported Event|Treatment as Usual|Treatment as usual control.
710012|NCT00223652|E1|Reported Event|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
710013|NCT00223496|B1|Baseline|Aripiprazole|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
710014|NCT00223496|P1|Participant Flow|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
710015|NCT00223496|O1|Outcome|Aripiprazole Plus Divalalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
710016|NCT00223496|E1|Reported Event|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
710017|NCT00223236|B3|Baseline|Total|Total of all reporting groups
710018|NCT00223236|B2|Baseline|Placebo|Inactive ingredient matching the active medication in appearance
710019|NCT00223236|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
710020|NCT00223236|P2|Participant Flow|Placebo|Inactive ingredient matching the active medication in appearance
710021|NCT00223236|P1|Participant Flow|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
710022|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
710023|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
710024|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
710025|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
710026|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
710027|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
710028|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
710029|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
710030|NCT00223236|E2|Reported Event|Placebo|Inactive ingredient matching the active medication in appearance
710031|NCT00223236|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
710032|NCT00222729|B1|Baseline|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
710033|NCT00222729|P1|Participant Flow|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
710034|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
710035|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
710036|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
710038|NCT00222729|E1|Reported Event|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
710039|NCT00222105|B1|Baseline|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
710040|NCT00222105|P1|Participant Flow|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
710041|NCT00222105|O1|Outcome|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
710042|NCT00222105|O1|Outcome|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
710043|NCT00222105|E1|Reported Event|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
710044|NCT00221299|B4|Baseline|Total|Total of all reporting groups
710045|NCT00221299|B3|Baseline|Parathyroid Hormone Placebo Injections and Risedronate Tables|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
710046|NCT00221299|B2|Baseline|Parathyroid Hormone Injections and Risedronate Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710047|NCT00221299|B1|Baseline|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710048|NCT00221299|P4|Participant Flow|Group3-rhPTH-Placebo&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710049|NCT00221299|P3|Participant Flow|Group2-rhPTH&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710050|NCT00221299|P2|Participant Flow|Group1b-rhPTH&RisendronatePlacebo|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710051|NCT00221299|P1|Participant Flow|Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for year 1. One 35mg tab of risedronate taken once a week for year 2.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710052|NCT00221299|O3|Outcome|Parathyroid Hormone Placebo&Risedronate|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
710053|NCT00221299|O2|Outcome|Parathyroid Hormone&Risedronate|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710054|NCT00221299|O1|Outcome|Parathyroid Hormone&Risedronate Placebo|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710055|NCT00221299|E3|Reported Event|Parathyroid Hormone Placebo Injections and Risedronate Tablets|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
710056|NCT00221299|E2|Reported Event|Parthyroid Hormone Injections and Risedronte Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710057|NCT00221299|E1|Reported Event|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
710058|NCT00221195|B3|Baseline|Total|Total of all reporting groups
714099|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
710059|NCT00221195|B2|Baseline|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
710060|NCT00221195|B1|Baseline|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
710061|NCT00221195|P2|Participant Flow|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
710062|NCT00221195|P1|Participant Flow|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
710063|NCT00221195|O2|Outcome|Bleeds During the Prophylaxis Period|
710064|NCT00221195|O1|Outcome|Bleeds During the On-demand Period|
710065|NCT00221195|E3|Reported Event|Washout Period|
710066|NCT00221195|E2|Reported Event|Prophylaxis Period|
710067|NCT00221195|E1|Reported Event|On-demand Period|
710068|NCT00221117|B3|Baseline|Total|Total of all reporting groups
710069|NCT00221117|B2|Baseline|Fes Therapy-Treatment Group|The FET began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes.
710070|NCT00221117|B1|Baseline|Conventional Occupational Therapy-Control Group|Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.
710071|NCT00221117|P2|Participant Flow|Fes Therapy-Treatment Group|The FET began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes.
710072|NCT00221117|P1|Participant Flow|Conventional Occupational Therapy-Control Group|Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.
710073|NCT00221117|O2|Outcome|Conventional Occupational Therapy|
710074|NCT00221117|O1|Outcome|FES Group|
710075|NCT00221117|O2|Outcome|Conventional Occupational Therapy|The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
710076|NCT00221117|O1|Outcome|FES Therapy|The Functional Independence Measure (FIM)15 was employed to measure the degree of disability for daily self-care.
710077|NCT00221117|E2|Reported Event|Fes Therapy-Treatment Group|The FET began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes.
710078|NCT00221117|E1|Reported Event|Control Group|Conventional Occupational Therapy
710079|NCT00221104|B3|Baseline|Total|Total of all reporting groups
710080|NCT00221104|B2|Baseline|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710081|NCT00221104|B1|Baseline|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710082|NCT00221104|P2|Participant Flow|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710083|NCT00221104|P1|Participant Flow|Pravastatin Group|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710084|NCT00221104|O2|Outcome|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710085|NCT00221104|O1|Outcome|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710086|NCT00221104|O2|Outcome|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710087|NCT00221104|O1|Outcome|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710088|NCT00221104|O2|Outcome|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710089|NCT00221104|O1|Outcome|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710090|NCT00221104|O2|Outcome|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710091|NCT00221104|O1|Outcome|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710092|NCT00221104|O2|Outcome|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710093|NCT00221104|O1|Outcome|Pravastatin|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710094|NCT00221104|E2|Reported Event|Control Group|The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
710095|NCT00221104|E1|Reported Event|Pravastatin Group|The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
710096|NCT00220961|B3|Baseline|Total|Total of all reporting groups
710097|NCT00220961|B2|Baseline|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
710098|NCT00220961|B1|Baseline|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
710099|NCT00220961|P2|Participant Flow|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets - 45mg/day tablet"
710100|NCT00220961|P1|Participant Flow|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day"
710101|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
710102|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
710103|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
710104|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
710105|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
710106|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
710107|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
710108|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
710109|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
710110|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
710111|NCT00220961|E2|Reported Event|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
710112|NCT00220961|E1|Reported Event|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
710113|NCT00220805|B3|Baseline|Total|Total of all reporting groups
710114|NCT00220805|B2|Baseline|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710115|NCT00220805|B1|Baseline|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710116|NCT00220805|P2|Participant Flow|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710117|NCT00220805|P1|Participant Flow|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710118|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710119|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710120|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710121|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710122|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710123|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710124|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710125|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710126|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710127|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710128|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710129|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710130|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710131|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710132|NCT00220805|E2|Reported Event|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
710133|NCT00220805|E1|Reported Event|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
710134|NCT00220779|B4|Baseline|Total|Total of all reporting groups
710135|NCT00220779|B3|Baseline|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
710136|NCT00220779|B2|Baseline|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
710137|NCT00220779|B1|Baseline|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
710138|NCT00220779|P3|Participant Flow|Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion|Immune globulin (intravenous) (IGIV)
710139|NCT00220779|P2|Participant Flow|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
710140|NCT00220779|P1|Participant Flow|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
710141|NCT00220779|O3|Outcome|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
710142|NCT00220779|O2|Outcome|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
710143|NCT00220779|O1|Outcome|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
710144|NCT00220779|E3|Reported Event|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
710145|NCT00220779|E2|Reported Event|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
710146|NCT00220779|E1|Reported Event|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
710147|NCT00220740|B3|Baseline|Total|Total of all reporting groups
710148|NCT00220740|B2|Baseline|Placebo|.1% albumin, 2 g/kg loading dose, followed by 1 g/kg maintenance dose
710149|NCT00220740|B1|Baseline|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
710150|NCT00220740|P2|Participant Flow|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
710151|NCT00220740|P1|Participant Flow|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
710152|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
710153|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
710154|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
710155|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
710156|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
710157|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
710158|NCT00220740|O2|Outcome|Placebo|
710159|NCT00220740|O1|Outcome|IGIV-C|
710160|NCT00220740|E2|Reported Event|Placebo|".1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose.~A total of 95 subjects were exposed to Placebo across all three treatments/periods."
710161|NCT00220740|E1|Reported Event|IGIV-C|"2 g/kg loading dose, followed by 1 g/kg maintenance dose.~A total of 113 subjects were exposed to IGIV-C across all three treatments/periods."
710162|NCT00220727|B3|Baseline|Total|Total of all reporting groups
710163|NCT00220727|B2|Baseline|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
710164|NCT00220727|B1|Baseline|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
710165|NCT00220727|P2|Participant Flow|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
710166|NCT00220727|P1|Participant Flow|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
710167|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
710168|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
710169|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
710170|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
710171|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
710172|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
710173|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
710174|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
710175|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
710176|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
710177|NCT00220727|E2|Reported Event|IGIV-C, 10% - 0.14 mL/kg/Min|IGIV-C (0.14 mL/kg/min);
710178|NCT00220727|E1|Reported Event|IGIV-C, 10% - 0.08 mL/kg/Min|IGIV-C (0.08 mL/kg/min);
710179|NCT00220701|B3|Baseline|Total|Total of all reporting groups
710180|NCT00220701|B2|Baseline|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710181|NCT00220701|B1|Baseline|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710379|NCT00218634|O2|Outcome|Enhanced Treatment as Usual|Enhanced treatment as usual (ETAU).
710182|NCT00220701|P2|Participant Flow|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710183|NCT00220701|P1|Participant Flow|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710184|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710185|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710186|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710187|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710188|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710189|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710190|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710191|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710192|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710193|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710194|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710195|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710196|NCT00220701|E2|Reported Event|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710197|NCT00220701|E1|Reported Event|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
710198|NCT00220636|B1|Baseline|Aripiprazole|aripiprazole augmentation treatment
710199|NCT00220636|P1|Participant Flow|Aripiprazole|aripiprazole augmentation treatment
710200|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
710201|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
710202|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment for treatment resistant depression
710203|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
710204|NCT00220636|E1|Reported Event|Aripiprazole|aripiprazole augmentation treatment
710205|NCT00219557|B4|Baseline|Total|Total of all reporting groups
710206|NCT00219557|B3|Baseline|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710207|NCT00219557|B2|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710208|NCT00219557|B1|Baseline|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710209|NCT00219557|P3|Participant Flow|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710210|NCT00219557|P2|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710211|NCT00219557|P1|Participant Flow|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710212|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710213|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710214|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710215|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710216|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710217|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710218|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710380|NCT00218634|O1|Outcome|Cognitive Behavioral Therapy for Adherence and Depression|Cognitive behavioral therapy focusing on treating depression and adherence to medication (CBT-AD).
710219|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710220|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710221|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710222|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710223|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710224|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710225|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710226|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710227|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710228|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710229|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710230|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710231|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710232|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710233|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710234|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710235|NCT00219557|E3|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710236|NCT00219557|E2|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally twice daily (BID) from Day 1 of Cycle 1 (28 days) and all subsequent cycles (28 days). Gemcitabine 1000 mg/m^2 30-minute infusion on Day 1, 8 and 15 of each cycle.
710237|NCT00219557|E1|Reported Event|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
710238|NCT00219544|B1|Baseline|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710239|NCT00219544|P2|Participant Flow|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710240|NCT00219544|P1|Participant Flow|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710241|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710242|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710381|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
710243|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710244|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710245|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710246|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710247|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710248|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710249|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710250|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710251|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710252|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710253|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710254|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710255|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710256|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710257|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
710258|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710259|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710260|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710261|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710382|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
710383|NCT00218634|E2|Reported Event|ETAU|Enhanced Treatment as Usual
710262|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710263|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710264|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
710265|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
710266|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
710267|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710268|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710269|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710270|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710271|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
710272|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710273|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
710274|NCT00219544|E3|Reported Event|Placebo Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
710275|NCT00219544|E2|Reported Event|Pregabalin Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatent phase.
710276|NCT00219544|E1|Reported Event|Pregabalin Single-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
710277|NCT00219349|B1|Baseline|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
710278|NCT00219349|P1|Participant Flow|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
710279|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710280|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710281|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710282|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710283|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710284|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710285|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710286|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
710287|NCT00219349|E1|Reported Event|Group 1|all subject entered
710288|NCT00219284|B3|Baseline|Total|Total of all reporting groups
710289|NCT00219284|B2|Baseline|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710290|NCT00219284|B1|Baseline|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710291|NCT00219284|P2|Participant Flow|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710292|NCT00219284|P1|Participant Flow|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710293|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710294|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710295|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710296|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710297|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710298|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710299|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710335|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710384|NCT00218634|E1|Reported Event|CBT-AD|Cognitive behavioral therapy for adherence and depression
710300|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710301|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710302|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710303|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710304|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710305|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710306|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710307|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710308|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710309|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710336|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710337|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710310|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710311|NCT00219284|E2|Reported Event|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710312|NCT00219284|E1|Reported Event|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
710313|NCT00219141|B4|Baseline|Total|Total of all reporting groups
710314|NCT00219141|B3|Baseline|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710315|NCT00219141|B2|Baseline|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710316|NCT00219141|B1|Baseline|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710317|NCT00219141|P3|Participant Flow|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710318|NCT00219141|P2|Participant Flow|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710319|NCT00219141|P1|Participant Flow|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710320|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710321|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710322|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710323|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710324|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710325|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710326|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710327|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710328|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710329|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710330|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710331|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710332|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710333|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710334|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710338|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710339|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710340|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710341|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710342|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710343|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710344|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710345|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710346|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710347|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710348|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710349|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710350|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710351|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710352|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710353|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710354|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710355|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710356|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710357|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710358|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710359|NCT00219141|E3|Reported Event|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
710360|NCT00219141|E2|Reported Event|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
710361|NCT00219141|E1|Reported Event|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
710362|NCT00218634|B3|Baseline|Total|Total of all reporting groups
710363|NCT00218634|B2|Baseline|ETAU|Enhanced Treatment as Usual
710364|NCT00218634|B1|Baseline|CBT-AD|Cognitive behavioral therapy for adherence and depression
710365|NCT00218634|P2|Participant Flow|ETAU|Enhanced Treatment as Usual
710366|NCT00218634|P1|Participant Flow|CBT-AD|Cognitive behavioral therapy for adherence and depression
710367|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
710368|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
710369|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
710370|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
710371|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
710372|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
710373|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
710374|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
710375|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
710376|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
710385|NCT00218543|B1|Baseline|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
710386|NCT00218543|P1|Participant Flow|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
710387|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
710388|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
710389|NCT00218543|E1|Reported Event|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
710390|NCT00218465|B3|Baseline|Total|Total of all reporting groups
710391|NCT00218465|B2|Baseline|Placebo|Placebo group for 5 week relapse prevention trial.
710392|NCT00218465|B1|Baseline|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
710393|NCT00218465|P2|Participant Flow|Placebo|Placebo group for 5 week relapse prevention trial.
710394|NCT00218465|P1|Participant Flow|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
710395|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
710396|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
710397|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
710398|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
710399|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
710400|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
710401|NCT00218465|E2|Reported Event|Placebo|Placebo group for 5 week relapse prevention trial.
710402|NCT00218465|E1|Reported Event|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
710403|NCT00218439|B3|Baseline|Total|Total of all reporting groups
710404|NCT00218439|B2|Baseline|Paroxetine First 4 Weeks, Then Placebo for 4 Weeks|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
710405|NCT00218439|B1|Baseline|Placebo First 4 Weeks, Then Paroxetine for 4 Weeks|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
710406|NCT00218439|P2|Participant Flow|Paroxetine (4 Weeks) the Placebo (4 Weeks)|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
710407|NCT00218439|P1|Participant Flow|Placebo (4 Weeks) Then Paroxetine (4 Weeks)|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
710408|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
710409|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
710410|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
714384|NCT00195507|B3|Baseline|Total|Total of all reporting groups
710411|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
710412|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
710413|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
710414|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
710415|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in diastolic blood pressure fom Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
710416|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
710417|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
710418|NCT00218439|E2|Reported Event|During 4 Weeks of Paroxetine|Participants received paroxetine 10 mg once daily for 1 week followed by 20 mg once daily for 3 weeks
710419|NCT00218439|E1|Reported Event|During 4 Weeks of Placebo|Participants receive placebo daily for 4 weeks
710420|NCT00218335|B5|Baseline|Total|Total of all reporting groups
710421|NCT00218335|B4|Baseline|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710422|NCT00218335|B3|Baseline|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710423|NCT00218335|B2|Baseline|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710424|NCT00218335|B1|Baseline|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710425|NCT00218335|P4|Participant Flow|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710426|NCT00218335|P3|Participant Flow|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710427|NCT00218335|P2|Participant Flow|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710428|NCT00218335|P1|Participant Flow|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710429|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710430|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710431|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710432|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710433|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710434|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710435|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710436|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710716|NCT00216476|B2|Baseline|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
710717|NCT00216476|B1|Baseline|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
710437|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710438|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710439|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710440|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710441|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710442|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710443|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710444|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710445|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710446|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710447|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710448|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710449|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710450|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710451|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710452|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710453|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710454|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710455|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710456|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710457|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710458|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710459|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710460|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710461|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710462|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710463|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710464|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710465|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710466|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710467|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710468|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710469|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710470|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710471|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710472|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710473|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710474|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710475|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710476|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710477|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710478|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710479|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710480|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710481|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710482|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710483|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710874|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
710484|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710485|NCT00218335|E4|Reported Event|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
710486|NCT00218335|E3|Reported Event|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
710487|NCT00218335|E2|Reported Event|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
710488|NCT00218335|E1|Reported Event|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
710489|NCT00218296|B3|Baseline|Total|Total of all reporting groups
710490|NCT00218296|B2|Baseline|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710491|NCT00218296|B1|Baseline|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710492|NCT00218296|P2|Participant Flow|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure.
710493|NCT00218296|P1|Participant Flow|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period.
710494|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710495|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710496|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710497|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710498|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710499|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710500|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710501|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710502|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710503|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710504|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710505|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710506|NCT00218296|E2|Reported Event|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
710507|NCT00218296|E1|Reported Event|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
710508|NCT00218062|B5|Baseline|Total|Total of all reporting groups
710509|NCT00218062|B4|Baseline|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710510|NCT00218062|B3|Baseline|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710511|NCT00218062|B2|Baseline|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710512|NCT00218062|B1|Baseline|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710513|NCT00218062|P4|Participant Flow|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710514|NCT00218062|P3|Participant Flow|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710515|NCT00218062|P2|Participant Flow|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710516|NCT00218062|P1|Participant Flow|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710517|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710518|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710519|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710520|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710619|NCT00217490|O4|Outcome|Physcial Activity-computer|"Physical activity counseling delivered by computer only~physical activity counseling via computer: An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan"
710718|NCT00216476|P3|Participant Flow|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
710521|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710522|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710523|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710524|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710525|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710526|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710527|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710528|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710529|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710530|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710531|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710532|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710533|NCT00218062|O4|Outcome|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710534|NCT00218062|O3|Outcome|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710535|NCT00218062|O2|Outcome|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710536|NCT00218062|O1|Outcome|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710537|NCT00218062|E4|Reported Event|Placebo + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710538|NCT00218062|E3|Reported Event|Modafinil 200mg + D-Amphetamine 30mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710539|NCT00218062|E2|Reported Event|Modafinil 400mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.~Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710540|NCT00218062|E1|Reported Event|D-Amphetamine 60mg + Therapy|"During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.~Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills."
710541|NCT00218023|B5|Baseline|Total|Total of all reporting groups
710542|NCT00218023|B4|Baseline|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710620|NCT00217490|O3|Outcome|Combined|"Dietary counseling delivered using computer program and nutritionist~combined computer and nutritionist: An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
710834|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
710543|NCT00218023|B3|Baseline|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710544|NCT00218023|B2|Baseline|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710545|NCT00218023|B1|Baseline|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710546|NCT00218023|P4|Participant Flow|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710547|NCT00218023|P3|Participant Flow|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710548|NCT00218023|P2|Participant Flow|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710549|NCT00218023|P1|Participant Flow|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710550|NCT00218023|O4|Outcome|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710551|NCT00218023|O3|Outcome|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710552|NCT00218023|O2|Outcome|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710553|NCT00218023|O1|Outcome|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710554|NCT00218023|O4|Outcome|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710555|NCT00218023|O3|Outcome|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710556|NCT00218023|O2|Outcome|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710557|NCT00218023|O1|Outcome|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710558|NCT00218023|E4|Reported Event|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710559|NCT00218023|E3|Reported Event|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710560|NCT00218023|E2|Reported Event|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710561|NCT00218023|E1|Reported Event|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
710562|NCT00217971|B3|Baseline|Total|Total of all reporting groups
710563|NCT00217971|B2|Baseline|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
710564|NCT00217971|B1|Baseline|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
710565|NCT00217971|P2|Participant Flow|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
710566|NCT00217971|P1|Participant Flow|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
710567|NCT00217971|O2|Outcome|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
710568|NCT00217971|O1|Outcome|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
710569|NCT00217971|E2|Reported Event|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
710570|NCT00217971|E1|Reported Event|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
710571|NCT00217724|B1|Baseline|Entire Study Population|Includes those randomized to Arms 1 and 2 in both course 1 and 2.
710572|NCT00217724|P2|Participant Flow|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
710573|NCT00217724|P1|Participant Flow|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
710574|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
710575|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
710576|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
710577|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
710578|NCT00217724|E2|Reported Event|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
710579|NCT00217724|E1|Reported Event|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
710621|NCT00217490|O2|Outcome|Counseling Only|"Dietary counseling delivered by nutritionist~dietary counseling via nutritionist: A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
710719|NCT00216476|P2|Participant Flow|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
710580|NCT00217672|B1|Baseline|Docetaxel + Bevacizumab|"docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.~A total of 104 participants were screened for the study. Twenty six participants did not meet eligibility criteria and 2 withdrew consent.~Seventy six participants were registered to the Treatment Period, 7 to arm A and 69 to arm B. Six out of 7 participants randomized to arm A elected to cross over to arm B once bevacizumab became available. Two out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. As a result, the efficacy analysis was performed on 67 patients."
710581|NCT00217672|P2|Participant Flow|Docetaxel|docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
710582|NCT00217672|P1|Participant Flow|Docetaxel+Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
710583|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
710584|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
710585|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
710586|NCT00217672|E1|Reported Event|Docetaxel and/or Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
710587|NCT00217620|B1|Baseline|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710588|NCT00217620|P1|Participant Flow|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710589|NCT00217620|O1|Outcome|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710590|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710591|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710592|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710593|NCT00217620|O4|Outcome|Total|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710594|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710595|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710596|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710597|NCT00217620|E1|Reported Event|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
710598|NCT00217581|B1|Baseline|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
710599|NCT00217581|P1|Participant Flow|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
710600|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
710601|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
710602|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
710603|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
710604|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
710605|NCT00217581|E1|Reported Event|Docetaxel, Oxaliplatin & Bevacizumab|"Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Bevacizumab: Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
710606|NCT00217490|B5|Baseline|Total|Total of all reporting groups
710607|NCT00217490|B4|Baseline|Physcial Activity-computer|Physical activity counseling delivered by computer only
710608|NCT00217490|B3|Baseline|Combined|Dietary counseling delivered using computer program and nutritionist
710609|NCT00217490|B2|Baseline|Counseling Only|Dietary counseling delivered by nutritionist
710610|NCT00217490|B1|Baseline|Computer Only|Dietary Counseling delivered by interactive computer
710611|NCT00217490|P4|Participant Flow|Physcial Activity-computer|Physical activity counseling delivered by computer only
710612|NCT00217490|P3|Participant Flow|Combined|Dietary counseling delivered using computer program and nutritionist
710613|NCT00217490|P2|Participant Flow|Counseling Only|Dietary counseling delivered by nutritionist
710614|NCT00217490|P1|Participant Flow|Computer Only|Dietary Counseling delivered by interactive computer
710615|NCT00217490|O4|Outcome|Physcial Activity-computer|Physical activity counseling delivered by computer only
710616|NCT00217490|O3|Outcome|Combined|Dietary counseling delivered using computer program and nutritionist
710617|NCT00217490|O2|Outcome|Counseling Only|Dietary counseling delivered by nutritionist
710618|NCT00217490|O1|Outcome|Computer Only|Dietary Counseling delivered by interactive computer
710720|NCT00216476|P1|Participant Flow|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
710622|NCT00217490|O1|Outcome|Computer Only|"Dietary Counseling delivered by interactive computer~dietary counseling via computer: An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
710623|NCT00217490|E4|Reported Event|Physcial Activity-computer|Physical activity counseling delivered by computer only
710624|NCT00217490|E3|Reported Event|Combined|Dietary counseling delivered using computer program and nutritionist
710625|NCT00217490|E2|Reported Event|Counseling Only|Dietary counseling delivered by nutritionist
710626|NCT00217490|E1|Reported Event|Computer Only|Dietary Counseling delivered by interactive computer
710627|NCT00217464|B1|Baseline|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
710628|NCT00217464|P1|Participant Flow|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
710629|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
710630|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
710631|NCT00217464|E1|Reported Event|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
710632|NCT00217438|B3|Baseline|Total|Total of all reporting groups
710633|NCT00217438|B2|Baseline|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710634|NCT00217438|B1|Baseline|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710635|NCT00217438|P2|Participant Flow|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710636|NCT00217438|P1|Participant Flow|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710637|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710638|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710721|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
710639|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710640|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710641|NCT00217438|E2|Reported Event|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710642|NCT00217438|E1|Reported Event|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
710643|NCT00217425|B1|Baseline|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
710644|NCT00217425|P1|Participant Flow|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
710645|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
710646|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
710722|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
710647|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
710648|NCT00217425|E1|Reported Event|Treatment (ACHOP Followed by MA)|Adverse events in all treated patients regardless of eligibility.
710649|NCT00217399|B1|Baseline|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
710650|NCT00217399|P1|Participant Flow|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
710651|NCT00217399|O1|Outcome|Circulating Endothelial Cells|All patients received sorafenib and anastrozole. Blood was drawn prior to beginning treatment and at set time points to analyze for circulating endothelial cells by flow cytometry
710652|NCT00217399|O1|Outcome|Sorefenib and Anastrozole|All patients receive sorafenib (400mg by mouth twice daily) and anastrazole (1 mg by mouth daily)
710653|NCT00217399|O1|Outcome|Sorafenib and Anastrozole|All patients receive sorafenib and anastrozole.
710654|NCT00217399|E1|Reported Event|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
710655|NCT00217087|B3|Baseline|Total|Total of all reporting groups
710656|NCT00217087|B2|Baseline|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
710657|NCT00217087|B1|Baseline|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
710658|NCT00217087|P2|Participant Flow|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
710659|NCT00217087|P1|Participant Flow|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
710660|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection and Photodynamic Therapy|Patients will have EMR (if indicated at time of endoscopy) followed by photodynamic therapy
710661|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo EMR at time of endoscopy if indicated.
710662|NCT00217087|O4|Outcome|Photodynamic Therapy FISH NEGATIVE|FISH cytology results prior to therapy were negative
710663|NCT00217087|O3|Outcome|Photodynamic Therapy FISH POSITIVE|FISH cytology results were positive prior to therapy
710664|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection FISH Positive Positive|FISH cytology results were positive prior to therapy
710665|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection FISH Polysomy Negative|FISH cytology results prior to therapy were negative
710666|NCT00217087|O2|Outcome|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
710667|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
710668|NCT00217087|E2|Reported Event|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
710669|NCT00217087|E1|Reported Event|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
710670|NCT00217022|B3|Baseline|Total|Total of all reporting groups
710671|NCT00217022|B2|Baseline|Placebo|three tablets daily
710672|NCT00217022|B1|Baseline|Budesonide|9 mg daily
710673|NCT00217022|P2|Participant Flow|Placebo|three tablets daily
710674|NCT00217022|P1|Participant Flow|Budesonide|9 mg daily
710675|NCT00217022|O2|Outcome|Placebo|three tablets daily
710676|NCT00217022|O1|Outcome|Budesonide|9 mg daily
710677|NCT00217022|O2|Outcome|Placebo|three tablets daily
710678|NCT00217022|O1|Outcome|Budesonide|9 mg daily
710679|NCT00217022|E2|Reported Event|Placebo|three tablets daily
710680|NCT00217022|E1|Reported Event|Budesonide|9 mg daily
710681|NCT00216736|B3|Baseline|Total|Total of all reporting groups
710682|NCT00216736|B2|Baseline|Dexamethasone|
710683|NCT00216736|B1|Baseline|Placebo|
710684|NCT00216736|P2|Participant Flow|Dexamethasone|
710685|NCT00216736|P1|Participant Flow|Placebo|
710686|NCT00216736|O2|Outcome|Dexamethasone|
710687|NCT00216736|O1|Outcome|Placebo|
710688|NCT00216736|O2|Outcome|Dexamethasone|
710689|NCT00216736|O1|Outcome|Placebo|
710690|NCT00216736|O2|Outcome|Dexamethasone|
710691|NCT00216736|O1|Outcome|Placebo|
710692|NCT00216736|O2|Outcome|Dexamethasone|
710693|NCT00216736|O1|Outcome|Placebo|
710694|NCT00216736|E2|Reported Event|Dexamethasone|
710695|NCT00216736|E1|Reported Event|Placebo|
710696|NCT00216671|B3|Baseline|Total|Total of all reporting groups
710697|NCT00216671|B2|Baseline|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
710714|NCT00216671|E1|Reported Event|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
710698|NCT00216671|B1|Baseline|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
710699|NCT00216671|P2|Participant Flow|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
710700|NCT00216671|P1|Participant Flow|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
710701|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
710702|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
710703|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
710704|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
710705|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
710706|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
710707|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
710708|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
710709|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
710710|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
710711|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
710712|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
710713|NCT00216671|E2|Reported Event|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
710723|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
710724|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
710725|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
710726|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
710727|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
710728|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
710729|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
710730|NCT00216476|O1|Outcome|Aripiprazole|oral, recommended maintenance dose of 10-30 mg q.d.
710731|NCT00216476|O2|Outcome|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
710732|NCT00216476|O1|Outcome|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
710733|NCT00216476|E3|Reported Event|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
710734|NCT00216476|E2|Reported Event|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
710735|NCT00216476|E1|Reported Event|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
710736|NCT00216320|B4|Baseline|Total|Total of all reporting groups
710737|NCT00216320|B3|Baseline|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
710738|NCT00216320|B2|Baseline|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
710739|NCT00216320|B1|Baseline|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
710740|NCT00216320|P3|Participant Flow|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
710741|NCT00216320|P2|Participant Flow|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
710742|NCT00216320|P1|Participant Flow|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
710743|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
710744|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
710745|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
710746|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
710747|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
710748|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
710749|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
710750|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
710751|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
710752|NCT00216320|O1|Outcome|Subjects Who Used Both WA and AFO|Subjects in arm 1 (wore WalkAide for 6 weeks followed by AFO for 6 weeks) and arm 2 (wore AFO for 6 weeks followed by WalkAide for 6 weeks)were given the option of continuing for 12 more weeks with their choice of device
710753|NCT00216320|E3|Reported Event|Arm 3|All subjects used AFO for all 12 weeks of study.
710754|NCT00216320|E2|Reported Event|Arm 2|All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.
710755|NCT00216320|E1|Reported Event|Arm 1|All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.
710756|NCT00216203|B1|Baseline|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710757|NCT00216203|P1|Participant Flow|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710758|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710759|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710760|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710761|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710762|NCT00216203|O1|Outcome|Investigational Treatment|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710811|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
710763|NCT00216203|E1|Reported Event|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
710764|NCT00216125|B1|Baseline|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
710765|NCT00216125|P3|Participant Flow|Observation Only|Patients were followed for Observation.
710766|NCT00216125|P2|Participant Flow|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
710767|NCT00216125|P1|Participant Flow|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
710768|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
710769|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
710770|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
710771|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
710772|NCT00216125|E3|Reported Event|Observation Only|Patients were followed for Observation.
710773|NCT00216125|E2|Reported Event|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
710774|NCT00216125|E1|Reported Event|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)~Adverse events reported in this arm consist only of participants that were not randomized into the Consolidation Docetaxel or Observation Only arms."
710775|NCT00216099|B1|Baseline|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710776|NCT00216099|P1|Participant Flow|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710777|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710778|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710779|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710780|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710781|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710782|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710783|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710784|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710785|NCT00216099|E1|Reported Event|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
710786|NCT00216086|B1|Baseline|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
710787|NCT00216086|P1|Participant Flow|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
710812|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
710813|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
710814|NCT00216060|E2|Reported Event|Risedronate|Daily oral risedronate combined with androgen deprivation
710788|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
710789|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
710790|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
710791|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
710792|NCT00216086|E1|Reported Event|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
710793|NCT00216060|B3|Baseline|Total|Total of all reporting groups
710794|NCT00216060|B2|Baseline|Placebo|daily oral placebo combined with androgen deprivation
710795|NCT00216060|B1|Baseline|Risedronate|Daily oral risedronate combined with androgen deprivation
710796|NCT00216060|P2|Participant Flow|Placebo|daily oral placebo combined with androgen deprivation
710797|NCT00216060|P1|Participant Flow|Risedronate|Daily oral risedronate combined with androgen deprivation
710798|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
710799|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
710800|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
710801|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
710802|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
710803|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
710804|NCT00216060|O2|Outcome|Placebo|daily oral placebo combined with androgen deprivation
710805|NCT00216060|O1|Outcome|Risedronate|Daily oral risedronate combined with androgen deprivation
710806|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
710807|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
710808|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
710809|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
710810|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
710815|NCT00216060|E1|Reported Event|Placebo|daily oral placebo combined with androgen deprivation
710817|NCT00215943|B2|Baseline|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
710818|NCT00215943|B1|Baseline|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
710819|NCT00215943|P2|Participant Flow|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
710820|NCT00215943|P1|Participant Flow|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
710821|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
710822|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
710823|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
710824|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
710825|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
710826|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
710827|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
710828|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
710829|NCT00215943|E2|Reported Event|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
710830|NCT00215943|E1|Reported Event|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
710831|NCT00215930|B1|Baseline|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
710832|NCT00215930|P1|Participant Flow|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of Ribonucleotide reductase subunit 1(ERCC1) and Excision repair cross-complementing group 1 gene (RRM1). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
710833|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
710835|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression. Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
710836|NCT00215930|E1|Reported Event|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
710837|NCT00215787|B1|Baseline|Lansoprazole|Lansoprazole 30mg BID for one year
710838|NCT00215787|P1|Participant Flow|Lansoprazole|Lansoprazole 30mg BID for one year
710839|NCT00215787|O1|Outcome|Lansoprazole|Lansoprazole 30mg BID for one year
710840|NCT00215787|E1|Reported Event|Lansoprazole|Lansoprazole 30mg BID for one year
710841|NCT00215683|B4|Baseline|Total|Total of all reporting groups
710842|NCT00215683|B3|Baseline|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710843|NCT00215683|B2|Baseline|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710844|NCT00215683|B1|Baseline|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710845|NCT00215683|P3|Participant Flow|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710846|NCT00215683|P2|Participant Flow|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710847|NCT00215683|P1|Participant Flow|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710848|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710849|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710850|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710851|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710852|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710853|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710854|NCT00215683|E3|Reported Event|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710855|NCT00215683|E2|Reported Event|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710856|NCT00215683|E1|Reported Event|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
710857|NCT00215657|B9|Baseline|Total|Total of all reporting groups
710858|NCT00215657|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
710859|NCT00215657|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
710860|NCT00215657|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
710861|NCT00215657|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
710862|NCT00215657|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
710863|NCT00215657|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
710864|NCT00215657|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
710865|NCT00215657|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
710866|NCT00215657|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
710867|NCT00215657|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
710868|NCT00215657|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
710869|NCT00215657|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
710870|NCT00215657|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
710871|NCT00215657|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
710872|NCT00215657|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
710873|NCT00215657|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
710875|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
710876|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
710877|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
710878|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
710879|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
710880|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
710881|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
710882|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
710883|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
710884|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
710885|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
710886|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
710887|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
710888|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
710889|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
710890|NCT00215657|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
710891|NCT00215657|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
710892|NCT00215657|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
710893|NCT00215657|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
710894|NCT00215657|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
710895|NCT00215657|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
710896|NCT00215657|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
710897|NCT00215657|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
710898|NCT00215553|B8|Baseline|Total|Total of all reporting groups
710899|NCT00215553|B7|Baseline|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
710900|NCT00215553|B6|Baseline|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710901|NCT00215553|B5|Baseline|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710902|NCT00215553|B4|Baseline|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710903|NCT00215553|B3|Baseline|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710904|NCT00215553|B2|Baseline|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710905|NCT00215553|B1|Baseline|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
710906|NCT00215553|P7|Participant Flow|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
710907|NCT00215553|P6|Participant Flow|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710908|NCT00215553|P5|Participant Flow|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710909|NCT00215553|P4|Participant Flow|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710910|NCT00215553|P3|Participant Flow|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710911|NCT00215553|P2|Participant Flow|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710912|NCT00215553|P1|Participant Flow|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
710913|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
710914|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710915|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710916|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710917|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710918|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710919|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
710920|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
710921|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710922|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710923|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710924|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710925|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710926|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
710927|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
710928|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710929|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710930|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710931|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710932|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710933|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
710934|NCT00215553|E7|Reported Event|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
710935|NCT00215553|E6|Reported Event|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710936|NCT00215553|E5|Reported Event|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710937|NCT00215553|E4|Reported Event|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
710938|NCT00215553|E3|Reported Event|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710939|NCT00215553|E2|Reported Event|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
710940|NCT00215553|E1|Reported Event|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
710941|NCT00215540|B4|Baseline|Total|Total of all reporting groups
710942|NCT00215540|B3|Baseline|Placebo|Sham air using 3.0 mL/kg volume of air
710943|NCT00215540|B2|Baseline|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710944|NCT00215540|B1|Baseline|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710945|NCT00215540|P3|Participant Flow|Placebo|Sham air using 3.0 mL/kg volume of air
710946|NCT00215540|P2|Participant Flow|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710947|NCT00215540|P1|Participant Flow|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710948|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710949|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710950|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710951|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710952|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710953|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710954|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710955|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710956|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710957|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710958|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710959|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710960|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710961|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710962|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710963|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710964|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710965|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710966|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710967|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710968|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710969|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710970|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710971|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710972|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710973|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710974|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710975|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
710976|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710977|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710978|NCT00215540|E3|Reported Event|Placebo|Sham air using 3.0 mL/kg volume of air
710979|NCT00215540|E2|Reported Event|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
710980|NCT00215540|E1|Reported Event|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
710981|NCT00215150|B1|Baseline|Study Treatment|8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects
710982|NCT00215150|P1|Participant Flow|Open Label Treatment|8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
710983|NCT00215150|O3|Outcome|Randomization Phase for Placebo Group|The group of subjects randomized to receive placebo for the second 8 weeks
710984|NCT00215150|O2|Outcome|Randomization Phase for Ziprasidone Group|The group of subjects randomized to receive Ziprasidone for the second 8 weeks
710985|NCT00215150|O1|Outcome|Open Label Phase|The open label treatment phase for the first 8 weeks
710986|NCT00215150|E3|Reported Event|Randomization Phase for Placebo|The second phase of treatment with subjects randomized to placebo augmentation.
710987|NCT00215150|E2|Reported Event|Randomization Phase for Ziprasidone|The second phase of treatment with subjects randomized to ziprasidone augmentation.
710988|NCT00215150|E1|Reported Event|Open Label Phase|The first 8 weeks of treatment on sertraline
710989|NCT00215137|B1|Baseline|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
710990|NCT00215137|P3|Participant Flow|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
710991|NCT00215137|P2|Participant Flow|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
710992|NCT00215137|P1|Participant Flow|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
710993|NCT00215137|O3|Outcome|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample.
710994|NCT00215137|O2|Outcome|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample.
710995|NCT00215137|O1|Outcome|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post baseline sample.
710996|NCT00215137|E3|Reported Event|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
710997|NCT00215137|E2|Reported Event|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
710998|NCT00215137|E1|Reported Event|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
710999|NCT00214903|B5|Baseline|Total|Total of all reporting groups
711000|NCT00214903|B4|Baseline|Non-oral HRT|Users of non-oral HRT preparations
711001|NCT00214903|B3|Baseline|ooHRT|Users of oral but not continuous combined HRT preparations
711002|NCT00214903|B2|Baseline|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
711003|NCT00214903|B1|Baseline|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
711004|NCT00214903|P4|Participant Flow|Non-oral HRT|Users of non-oral HRT preparations
711005|NCT00214903|P3|Participant Flow|ooHRT|Users of oral but not continuous combined HRT preparations
711006|NCT00214903|P2|Participant Flow|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
711007|NCT00214903|P1|Participant Flow|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
711008|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
711009|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
711010|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
711011|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
711012|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
711013|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
711014|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
711015|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
711016|NCT00214903|E4|Reported Event|Non-oral HRT|Users of non-oral HRT preparations
711017|NCT00214903|E3|Reported Event|ooHRT|Users of oral but not continuous combined HRT preparations
711018|NCT00214903|E2|Reported Event|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
711019|NCT00214903|E1|Reported Event|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
711020|NCT00214786|B1|Baseline|Islet Cell|Patients with allogeneic islet cell transplantation
711021|NCT00214786|P1|Participant Flow|Islet Cell Transplantation|Patients who received islet cell transplantation. The recipients will be given islet cell preparation with more than 4000 Islet Equivalent (IE)/kg for multiple times up to 3 infusions.
711022|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711023|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711024|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711025|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711026|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711027|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711028|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711029|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711030|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711031|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
711032|NCT00214786|E1|Reported Event|Islet Cell|Patients with allogeneic islet cell transplantation
711033|NCT00214539|B3|Baseline|Total|Total of all reporting groups
711034|NCT00214539|B2|Baseline|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711035|NCT00214539|B1|Baseline|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711036|NCT00214539|P2|Participant Flow|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711037|NCT00214539|P1|Participant Flow|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711038|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711039|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711040|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711041|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711042|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711043|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711044|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711045|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711046|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711047|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711048|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711049|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711050|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711051|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711052|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
711053|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
711054|NCT00214539|E6|Reported Event|Control (Steroid Wean and Reduced Steroid Phases)|
711055|NCT00214539|E5|Reported Event|Alair (Steroid Wean and Reduced Steroid Phases)|
711056|NCT00214539|E4|Reported Event|Control (Steroid Stable Phase)|
711057|NCT00214539|E3|Reported Event|Alair (Steroid Stable Phase)|
711058|NCT00214539|E2|Reported Event|Control (Treatment Period)|
711059|NCT00214539|E1|Reported Event|Alair (Treatment Period)|
711060|NCT00214526|B3|Baseline|Total|Total of all reporting groups
711061|NCT00214526|B2|Baseline|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711062|NCT00214526|B1|Baseline|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711063|NCT00214526|P2|Participant Flow|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711064|NCT00214526|P1|Participant Flow|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711065|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711066|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711067|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711068|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711069|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711070|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711071|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711072|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711073|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711074|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711075|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711076|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711077|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711078|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711079|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711080|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711081|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711082|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711125|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
711083|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711084|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
711085|NCT00214526|E4|Reported Event|Control (Post-Treatment Period)|From 6 weeks after last Control visit through 1 year.
711086|NCT00214526|E3|Reported Event|Alair (Post-Treatment Period)|From 6 weeks after last Treatment visit through 1 year.
711087|NCT00214526|E2|Reported Event|Control (Treatment Period)|From first Control visit through 6 weeks after last Control visit.
711088|NCT00214526|E1|Reported Event|Alair (Treatment Period)|From first Treatment visit through 6 weeks after last Treatment visit.
711089|NCT00214487|B3|Baseline|Total|Total of all reporting groups
711090|NCT00214487|B2|Baseline|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
711091|NCT00214487|B1|Baseline|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
711092|NCT00214487|P2|Participant Flow|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
711093|NCT00214487|P1|Participant Flow|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
711094|NCT00214487|O2|Outcome|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
711095|NCT00214487|O1|Outcome|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
711096|NCT00214487|E2|Reported Event|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
711097|NCT00214487|E1|Reported Event|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
711098|NCT00214461|B5|Baseline|Total|Total of all reporting groups
711099|NCT00214461|B4|Baseline|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
711100|NCT00214461|B3|Baseline|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711101|NCT00214461|B2|Baseline|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711102|NCT00214461|B1|Baseline|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
711103|NCT00214461|P4|Participant Flow|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
711104|NCT00214461|P3|Participant Flow|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711105|NCT00214461|P2|Participant Flow|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711106|NCT00214461|P1|Participant Flow|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
711107|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
711108|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711109|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711110|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
711111|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
711112|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711113|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711114|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
711115|NCT00214461|E4|Reported Event|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
711116|NCT00214461|E3|Reported Event|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711117|NCT00214461|E2|Reported Event|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
711118|NCT00214461|E1|Reported Event|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
711119|NCT00214383|B3|Baseline|Total|Total of all reporting groups
711120|NCT00214383|B2|Baseline|Control|Control-usual care
711121|NCT00214383|B1|Baseline|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
711122|NCT00214383|P2|Participant Flow|Control|Control-usual care
711123|NCT00214383|P1|Participant Flow|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
711124|NCT00214383|O2|Outcome|Control|Control-usual care
711126|NCT00214383|O2|Outcome|Control|Control-usual care
711127|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
711128|NCT00214383|O2|Outcome|Control|Control-usual care
711129|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
711130|NCT00214383|E2|Reported Event|Control|Control-usual care
711131|NCT00214383|E1|Reported Event|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
711132|NCT00214201|B3|Baseline|Total|Total of all reporting groups
711133|NCT00214201|B2|Baseline|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
711134|NCT00214201|B1|Baseline|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
711135|NCT00214201|P2|Participant Flow|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
711136|NCT00214201|P1|Participant Flow|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
711137|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
711138|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
711139|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
711140|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of care CNI Immunosuppression
711141|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
711142|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
711143|NCT00214201|E2|Reported Event|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
711144|NCT00214201|E1|Reported Event|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
711145|NCT00214136|B1|Baseline|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
711146|NCT00214136|P1|Participant Flow|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
711147|NCT00214136|O1|Outcome|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
711148|NCT00214136|O1|Outcome|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
711149|NCT00214136|E1|Reported Event|Experimental|Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
711150|NCT00214019|B1|Baseline|4 Way Cross Over|"Participants completed all 4 arms:~Placebo, Salmeterol diskus 40 mcg twice per day, Placebo then fluticasone, Salmeterol then Fluticasone,"
711151|NCT00214019|P1|Participant Flow|All Study Participants|All participants completed all 4 arms of the study. 28 days per arm.
711152|NCT00214019|O4|Outcome|Salmeterol/Fluticasone|Participants on Salmeterol/Fluticasone
711153|NCT00214019|O3|Outcome|Placebo/fFuticasone|Participants on Placebo/Fluticasone arm
711154|NCT00214019|O2|Outcome|Placebo/Salmeterol|Participants on Placebo/Salmeterol arm
711155|NCT00214019|O1|Outcome|Placebo/Placebo|Participants on Placebo/Placebo arm
711156|NCT00214019|E1|Reported Event|4 Way Cross Over|"Participants completed all 4 treatments:~Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone"
711157|NCT00213980|B3|Baseline|Total|Total of all reporting groups
711158|NCT00213980|B2|Baseline|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
711159|NCT00213980|B1|Baseline|Observation|Observation only for 12 months
711160|NCT00213980|P2|Participant Flow|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
711161|NCT00213980|P1|Participant Flow|Observation|Observation only for 12 months
711162|NCT00213980|O2|Outcome|Observation|Observation only for 12 months
711163|NCT00213980|O1|Outcome|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
711164|NCT00213980|O2|Outcome|Observation|Observation only for 12 months
711165|NCT00213980|O1|Outcome|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
711166|NCT00213980|O2|Outcome|Observation|Observation only for 12 months
711167|NCT00213980|O1|Outcome|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
711168|NCT00213980|O2|Outcome|Observation|Observation only for 12 months
711169|NCT00213980|O1|Outcome|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
711170|NCT00213980|E2|Reported Event|Zoledronic Acid (ZA)|"ZA~Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles"
711171|NCT00213980|E1|Reported Event|Observation|Observation only for 12 months
711172|NCT00213135|B4|Baseline|Total|Total of all reporting groups
711173|NCT00213135|B3|Baseline|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
711231|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711174|NCT00213135|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
711175|NCT00213135|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
711176|NCT00213135|P3|Participant Flow|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
711177|NCT00213135|P2|Participant Flow|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
711178|NCT00213135|P1|Participant Flow|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
711179|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
711180|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
711181|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
711182|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
711183|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
711184|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
711185|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
711186|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
711187|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
711188|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
711189|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
711190|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
711191|NCT00213135|E3|Reported Event|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
711192|NCT00213135|E2|Reported Event|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
711193|NCT00213135|E1|Reported Event|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
711194|NCT00212758|B1|Baseline|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
711195|NCT00212758|P2|Participant Flow|Standard- Low- Standard GH|This group was randomized to receive 0.05 mg/kg/day of growth hormone for 7 doses given subcutaneously followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the low dose of 0.025 mg/kg/day for 7 days.
711196|NCT00212758|P1|Participant Flow|Low-standard-standard GH|This group was randomized to receive 0.025 mg/kg/day of growth hormone for 7 doses given subcutaneously, followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the standard dose of 0.05 mg/kg/day for 7 days.
711197|NCT00212758|O1|Outcome|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
711198|NCT00212758|O2|Outcome|Standard Dose GH|Subjects will be randomized to either a low or standard arm. The Standard dose GH group will get 0.05 mg/kg/day of growth hormone therapy for 7 days followed by 2 week wash out and then another 7 days of GH therapy on the low dose of 0.025 mg/kg/dose given subcutaneously.
711199|NCT00212758|O1|Outcome|Low Dose GH|Subjects will be randomized to either a low or standard arm. The low dose GH group will get 0.025 mg/kg/day of growth hormone therapy for 7 days followed by 2 weeks of wash out and then another 7 days of GH therapy on the standard dose of 0.05 mg/kg/dose given subcutaneously.
711200|NCT00212758|E1|Reported Event|All Participants|There will be 2 arms in the study who will be randomized in a cross over design. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months.
711201|NCT00212355|B1|Baseline|NPC-02|"zinc acetate~NPC-02: zinc acetate"
711202|NCT00212355|P1|Participant Flow|NPC-02|"zinc acetate~NPC-02: zinc acetate"
711203|NCT00212355|O1|Outcome|NPC-02|"zinc acetate~NPC-02: zinc acetate"
711204|NCT00212355|E1|Reported Event|NPC-02|"zinc acetate~NPC-02: zinc acetate"
711205|NCT00212264|B4|Baseline|Total|Total of all reporting groups
711206|NCT00212264|B3|Baseline|Placebo Comparator|No treatment control
711207|NCT00212264|B2|Baseline|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
711208|NCT00212264|B1|Baseline|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
711209|NCT00212264|P3|Participant Flow|Placebo Comparator|No treatment control
711210|NCT00212264|P2|Participant Flow|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
711211|NCT00212264|P1|Participant Flow|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
711212|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
711213|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
711214|NCT00212264|O3|Outcome|Placebo Comparator|No treatment control
711215|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
711216|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
711217|NCT00212264|E3|Reported Event|Placebo Comparator|No treatment control
711218|NCT00212264|E2|Reported Event|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
711219|NCT00212264|E1|Reported Event|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
711220|NCT00212134|B3|Baseline|Total|Total of all reporting groups
711221|NCT00212134|B2|Baseline|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711222|NCT00212134|B1|Baseline|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711223|NCT00212134|P2|Participant Flow|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711224|NCT00212134|P1|Participant Flow|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711225|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711226|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711227|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711228|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711229|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711230|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711232|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711233|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.~primary implantation of aphakic intraocular lens: optical correction of surgical aphakia with intraocular lens"
711234|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.~hyperopic correction of infant surgical aphakia with Contact Lens: optical correction of infant surgical aphakia with Contact lens"
711235|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711236|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711237|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: The refractive error induced by surgical removal of the cataractous natural lens is partially corrected by the implantation of an intraocular lens (IOL) at the time of surgery. This is deemed a permanent correction as the IOL may only be removed in a subsequent surgery."
711238|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly."
711239|NCT00212134|E2|Reported Event|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
711240|NCT00212134|E1|Reported Event|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
711241|NCT00211887|B4|Baseline|Total|Total of all reporting groups
711242|NCT00211887|B3|Baseline|Glatiramer|glatiramer acetate
711243|NCT00211887|B2|Baseline|IFB-1a|Interferon beta-1a
711244|NCT00211887|B1|Baseline|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
711245|NCT00211887|P3|Participant Flow|Glatiramer Acetate|glatiramer acetate 20mg daily
711246|NCT00211887|P2|Participant Flow|Interferon Beta 1a|Interferon beta-1a 30µg intramuscularly weekly
711247|NCT00211887|P1|Participant Flow|IFN + GA|Interferon beta-1a 30µg intramuscularly weekly and glatiramer acetate (GA) 20mg daily
711248|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
711249|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
711250|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
711251|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
711252|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
711253|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
711254|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
711255|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
711256|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
711257|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
711258|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
711259|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
711260|NCT00211887|E3|Reported Event|Glatiramer|glatiramer acetate
711261|NCT00211887|E2|Reported Event|IFB-1a|Interferon beta-1a
711262|NCT00211887|E1|Reported Event|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
711263|NCT00211809|B1|Baseline|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
711264|NCT00211809|P1|Participant Flow|Body Dysmorphic Disorder|"Participants with body dysmorphic disorder~Standard Psychiatric Evaluation~Venlafaxine: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks."
711265|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
711266|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
711267|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
711268|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
711269|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
711270|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
711271|NCT00211809|O1|Outcome|Body Dysmorphic Disorder|Participants with body dysmorphic disorder after Venlafaxine treatment up to 16 weeks
711272|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
711273|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
711274|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
711275|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
711276|NCT00211809|E1|Reported Event|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
711277|NCT00211692|B3|Baseline|Total|Total of all reporting groups
711278|NCT00211692|B2|Baseline|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
711279|NCT00211692|B1|Baseline|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
711280|NCT00211692|P2|Participant Flow|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
714754|NCT00194129|B3|Baseline|Total|Total of all reporting groups
711281|NCT00211692|P1|Participant Flow|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
711282|NCT00211692|O1|Outcome|Overall|
711283|NCT00211692|O1|Outcome|Overall|
711284|NCT00211692|O1|Outcome|Overall|
711285|NCT00211692|O2|Outcome|B (Duration Based on Viral Response)|
711286|NCT00211692|O1|Outcome|A (52 Weeks Treatment)|
711287|NCT00211692|E1|Reported Event|Overall|
711288|NCT00211536|B3|Baseline|Total|Total of all reporting groups
711289|NCT00211536|B2|Baseline|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711290|NCT00211536|B1|Baseline|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711291|NCT00211536|P2|Participant Flow|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711292|NCT00211536|P1|Participant Flow|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711293|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711294|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711295|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711296|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
712347|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
711297|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711298|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711299|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711300|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711301|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711302|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
711303|NCT00211536|E2|Reported Event|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group. All randomized subjects were assessed for safety risk."
711304|NCT00211536|E1|Reported Event|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~Results were analyzed for subjects that completed beyond V5, which was the end of the first 90 day period of IP insulin therapy. These were considered to be the As Treated group.~All randomized subjects were assessed for safety risk."
711305|NCT00211510|B3|Baseline|Total|Total of all reporting groups
711306|NCT00211510|B2|Baseline|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
711307|NCT00211510|B1|Baseline|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711308|NCT00211510|P2|Participant Flow|Paradigm 715 Insulin Pump|subjects with use the Paradigm 715 insulin pump for insulin infusion
711309|NCT00211510|P1|Participant Flow|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711310|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
711311|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 711 sensor augmented pump for insulin infusion and continuous glucose monitoring
712348|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
711312|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
711313|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711314|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
711315|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects with use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711316|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
711317|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711318|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 pump for insulin infusion
711319|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711320|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
711321|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711322|NCT00211510|E2|Reported Event|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
711323|NCT00211510|E1|Reported Event|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
711324|NCT00211237|B3|Baseline|Total|Total of all reporting groups
711325|NCT00211237|B2|Baseline|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711326|NCT00211237|B1|Baseline|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711327|NCT00211237|P3|Participant Flow|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711328|NCT00211237|P2|Participant Flow|Non-surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711329|NCT00211237|P1|Participant Flow|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711330|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711331|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711332|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711333|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711334|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711335|NCT00211237|O4|Outcome|Crossover-(AEs Collected After BKP)|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711336|NCT00211237|O3|Outcome|Crossover (AEs Collected Before BKP)|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711337|NCT00211237|O2|Outcome|Non Surgical Management|The subjects were randomized to NSM without crossing over.
711338|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects were randomized to Balloon Kyphoplasty.
711339|NCT00211237|O2|Outcome|Non Surgical Management|The subjects were randomized to NSM.
711340|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects were randomized to the Balloon Kyphoplasty.
711341|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711342|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711343|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711344|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711345|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711346|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711347|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711348|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711349|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711350|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711351|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711590|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711352|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711353|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711354|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711355|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711356|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711357|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711358|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711359|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711360|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711361|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711362|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711363|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711364|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711365|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711366|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711367|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711368|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711369|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711370|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711371|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711372|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711373|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711374|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711375|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711376|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711377|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711378|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711379|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711380|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711381|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711382|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711383|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711384|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711385|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711386|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711387|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711951|NCT00208507|B3|Baseline|Total|Total of all reporting groups
711388|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711389|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711390|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711391|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711392|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711393|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711394|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711395|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711396|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711397|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711398|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711399|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711400|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711401|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711402|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711403|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711404|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711405|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711406|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711407|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711408|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711409|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711410|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711411|NCT00211237|O3|Outcome|Crossover|Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
711412|NCT00211237|O2|Outcome|Non-Surgical Management|The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711413|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
711414|NCT00211237|O2|Outcome|Non Surgical Management|The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711415|NCT00211237|O1|Outcome|Balloon Kyphoplasty|The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs.
711416|NCT00211237|E2|Reported Event|Non Surgical Management|The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
711417|NCT00211237|E1|Reported Event|Balloon Kyphoplasty|The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.
711418|NCT00211172|B3|Baseline|Total|Total of all reporting groups
711419|NCT00211172|B2|Baseline|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
711420|NCT00211172|B1|Baseline|Usual Care|Usual care patients were not contacted by the study.
711460|NCT00210470|E1|Reported Event|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
711461|NCT00209560|B3|Baseline|Total|Total of all reporting groups
714755|NCT00194129|B2|Baseline|Lithium Plus Placebo|
711421|NCT00211172|P2|Participant Flow|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
711422|NCT00211172|P1|Participant Flow|Usual Care|Usual care patients were not contacted by the study.
711423|NCT00211172|O2|Outcome|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
711424|NCT00211172|O1|Outcome|Usual Care|Usual care patients were not contacted by the study.
711425|NCT00211172|E2|Reported Event|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
711426|NCT00211172|E1|Reported Event|Usual Care|Usual care patients were not contacted by the study.
711427|NCT00211081|B1|Baseline|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711428|NCT00211081|P1|Participant Flow|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711429|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711430|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711431|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711432|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711433|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711434|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711435|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711436|NCT00211081|E1|Reported Event|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
711437|NCT00210639|B3|Baseline|Total|Total of all reporting groups
711438|NCT00210639|B2|Baseline|Comparator|Participants who received comparator in the previous studies.
711439|NCT00210639|B1|Baseline|Levofloxacin|Participants who received levofloxacin in the previous studies.
711440|NCT00210639|P2|Participant Flow|Comparator|Participants who received comparator in the previous studies.
711441|NCT00210639|P1|Participant Flow|Levofloxacin|Participants who received levofloxacin in the previous studies.
711442|NCT00210639|O2|Outcome|Comparator|Participants who received comparator in the previous studies.
711443|NCT00210639|O1|Outcome|Levofloxacin|Participants who received levofloxacin in the previous studies.
711444|NCT00210639|E2|Reported Event|Comparator|Participants who received comparator in the previous studies.
711445|NCT00210639|E1|Reported Event|Levofloxacin|Participants who received levofloxacin in the previous studies.
711446|NCT00210626|B3|Baseline|Total|Total of all reporting groups
711447|NCT00210626|B2|Baseline|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
711448|NCT00210626|B1|Baseline|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
711449|NCT00210626|P2|Participant Flow|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
711450|NCT00210626|P1|Participant Flow|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
711451|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
711452|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
711453|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
711454|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
711455|NCT00210626|E2|Reported Event|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
711456|NCT00210626|E1|Reported Event|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
711457|NCT00210470|B1|Baseline|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
711458|NCT00210470|P1|Participant Flow|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
711459|NCT00210470|O1|Outcome|IRX-2 Regimen|A 2-week course of IRX-2, an initial low dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation
714756|NCT00194129|B1|Baseline|Lithium Plus Divalproex|
711462|NCT00209560|B2|Baseline|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
711463|NCT00209560|B1|Baseline|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
711464|NCT00209560|P2|Participant Flow|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
711465|NCT00209560|P1|Participant Flow|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
711466|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
711467|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
711468|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
711469|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
711470|NCT00209560|E2|Reported Event|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
711471|NCT00209560|E1|Reported Event|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
711472|NCT00209417|B3|Baseline|Total|Total of all reporting groups
711473|NCT00209417|B2|Baseline|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
711474|NCT00209417|B1|Baseline|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
711475|NCT00209417|P2|Participant Flow|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
711476|NCT00209417|P1|Participant Flow|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
711477|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
711478|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
711479|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
711480|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
711481|NCT00209417|E2|Reported Event|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
711482|NCT00209417|E1|Reported Event|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
711483|NCT00209339|B1|Baseline|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711484|NCT00209339|P1|Participant Flow|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711485|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711486|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711487|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711488|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711489|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711490|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711491|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711492|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711493|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711494|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711495|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
712349|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
711496|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711497|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711498|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711499|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711500|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711501|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711502|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711503|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711504|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711505|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711506|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711507|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711508|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711509|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711510|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711511|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711512|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711513|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711514|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711515|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711516|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711517|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711518|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711519|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711520|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711521|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711522|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711523|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711524|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711525|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711526|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711527|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711528|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711529|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711530|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711531|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711532|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711533|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711534|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711535|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711536|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711537|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711538|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711539|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711540|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711541|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711542|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711543|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711544|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711545|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711546|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711547|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711548|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711549|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711550|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711551|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711552|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711553|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711554|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711555|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711556|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711557|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711558|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711559|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711560|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711561|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711562|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711563|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711564|NCT00209339|E1|Reported Event|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
711565|NCT00209274|B3|Baseline|Total|Total of all reporting groups
711566|NCT00209274|B2|Baseline|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711567|NCT00209274|B1|Baseline|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711568|NCT00209274|P2|Participant Flow|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711569|NCT00209274|P1|Participant Flow|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711570|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711571|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711572|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711573|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711574|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711575|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711576|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711577|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711578|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711579|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711580|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711581|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711582|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711583|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711584|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711585|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711586|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711587|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711588|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711589|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711591|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711592|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711593|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711594|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711595|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711596|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711597|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711598|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711599|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711600|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711601|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711602|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711603|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711604|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711605|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711606|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711607|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711608|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711609|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711610|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711611|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711612|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711613|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711614|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711615|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711616|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711617|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711618|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711619|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711620|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711621|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711622|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711623|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711624|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711625|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711626|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711627|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711628|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711629|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711630|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711631|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711632|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711633|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711634|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711635|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711636|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711637|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711638|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711639|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711640|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711641|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711642|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711643|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711644|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711645|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711646|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
715969|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
711647|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711648|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711649|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711650|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711651|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711652|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711653|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711654|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711655|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711656|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711657|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711658|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711659|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711660|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711661|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711662|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711663|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711664|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711665|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711666|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711667|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711668|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711669|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711670|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711671|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711672|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711673|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711674|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711675|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711676|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711677|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711678|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711679|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711680|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711681|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711682|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711683|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711684|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711685|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711686|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711687|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711688|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711689|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711690|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711691|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711692|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711693|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711694|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711695|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711696|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711697|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711698|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711699|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711700|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711701|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711702|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
716272|NCT00186043|O2|Outcome|Placebo|Placebo comparator
711703|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711704|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711705|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711706|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711707|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711708|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711709|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711710|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711711|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711712|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711713|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711714|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711715|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711716|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711717|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711718|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711719|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711720|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711721|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711722|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711723|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711724|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711725|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711726|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711727|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711728|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711729|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711730|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711731|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711732|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711733|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711734|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711735|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711736|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711737|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711738|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711739|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711740|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711741|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711742|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711743|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711744|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711745|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711746|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711747|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711748|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711749|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711750|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711751|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711752|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711753|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711754|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711755|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711756|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711757|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711758|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
716691|NCT00183625|O1|Outcome|Risperidone Treatment|
711759|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711760|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711761|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711762|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711763|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711764|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711765|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711766|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711767|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711768|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711769|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711770|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711771|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711772|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711773|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711774|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711775|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711776|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711777|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711778|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711779|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711780|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711781|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711782|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711783|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711784|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711785|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711786|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711787|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711788|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711789|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711790|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711791|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711792|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711793|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711794|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711795|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711796|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711797|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711798|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711799|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711800|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711801|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711802|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711803|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711804|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711805|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711806|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711807|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711808|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711809|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711810|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711811|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711812|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711813|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711814|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
719138|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
711815|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711816|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711817|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711818|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711819|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711820|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711821|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711822|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711823|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711824|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711825|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711826|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711827|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711828|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711829|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711830|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711831|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711832|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711833|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711834|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711835|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711836|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711837|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711838|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711839|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711840|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711841|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711842|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711843|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711844|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711845|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711846|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711847|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711848|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711849|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711850|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711851|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711852|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711853|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711854|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711855|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711856|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711857|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711858|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711859|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711860|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711861|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711862|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711863|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711864|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711865|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711866|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711867|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711868|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711869|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711870|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
719139|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
711871|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711872|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711873|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711874|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711875|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711876|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711877|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711878|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711879|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711880|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711881|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711882|NCT00209274|O2|Outcome|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711883|NCT00209274|O1|Outcome|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711884|NCT00209274|E2|Reported Event|Control Group (Mitral Valve Surgery)|Mitral valve repair or replacement surgery.
711885|NCT00209274|E1|Reported Event|Device Group (MitraClip Device)|Percutaneous mitral valve repair using MitraClip implant.
711886|NCT00209170|B3|Baseline|Total|Total of all reporting groups
711887|NCT00209170|B2|Baseline|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
711888|NCT00209170|B1|Baseline|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
711889|NCT00209170|P2|Participant Flow|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
711890|NCT00209170|P1|Participant Flow|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
711891|NCT00209170|O2|Outcome|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
711892|NCT00209170|O1|Outcome|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
711893|NCT00209170|E2|Reported Event|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
711894|NCT00209170|E1|Reported Event|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
711895|NCT00209131|B3|Baseline|Total|Total of all reporting groups
711896|NCT00209131|B2|Baseline|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
711897|NCT00209131|B1|Baseline|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
711898|NCT00209131|P2|Participant Flow|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
711899|NCT00209131|P1|Participant Flow|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
711900|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
711901|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
711902|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
711903|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
711904|NCT00209131|E2|Reported Event|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
711905|NCT00209131|E1|Reported Event|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
711906|NCT00209092|B3|Baseline|Total|Total of all reporting groups
711907|NCT00209092|B2|Baseline|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
711908|NCT00209092|B1|Baseline|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
711909|NCT00209092|P2|Participant Flow|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
711910|NCT00209092|P1|Participant Flow|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
711911|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
711912|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
711913|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
711914|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
711915|NCT00209092|E2|Reported Event|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
711916|NCT00209092|E1|Reported Event|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
711917|NCT00209027|B3|Baseline|Total|Total of all reporting groups
711918|NCT00209027|B2|Baseline|Controls|Baseline fMRI scan
711919|NCT00209027|B1|Baseline|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
711920|NCT00209027|P2|Participant Flow|Controls|Baseline fMRI scan
711921|NCT00209027|P1|Participant Flow|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
711922|NCT00209027|O2|Outcome|Controls|Healthy males without a psychiatric diagnosis
711923|NCT00209027|O1|Outcome|Schizophrenia Subjects|Males patients with schizophrenia
711924|NCT00209027|E2|Reported Event|Controls|Baseline fMRI scan
711925|NCT00209027|E1|Reported Event|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
711926|NCT00208975|B1|Baseline|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
711927|NCT00208975|P1|Participant Flow|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
711928|NCT00208975|O2|Outcome|Non Hodgkin Lymphoma|"Non-Hodgkin's lymphoma, also called non-Hodgkin lymphoma, is cancer that originates in your lymphatic system, the disease-fighting network spread throughout your body. In non-Hodgkin's lymphoma, tumors develop from lymphocytes — a type of white blood cell.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
711929|NCT00208975|O1|Outcome|Chronic Lymphocytic Leukemia|"Chronic Lymphocytic Leukemia (CLL) is a condition characterized by an accumulation of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
711930|NCT00208975|E1|Reported Event|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
711931|NCT00208949|B3|Baseline|Total|Total of all reporting groups
711932|NCT00208949|B2|Baseline|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
711933|NCT00208949|B1|Baseline|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
711934|NCT00208949|P2|Participant Flow|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
711935|NCT00208949|P1|Participant Flow|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
711936|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
711937|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
711938|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
711939|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
711940|NCT00208949|E2|Reported Event|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
711941|NCT00208949|E1|Reported Event|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
711942|NCT00208767|B3|Baseline|Total|Total of all reporting groups
711943|NCT00208767|B2|Baseline|Placebo|Patients received a placebo instead of Valsartan
711944|NCT00208767|B1|Baseline|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
711945|NCT00208767|P2|Participant Flow|Placebo|Patients received a placebo instead of Valsartan
711946|NCT00208767|P1|Participant Flow|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
711947|NCT00208767|O2|Outcome|Placebo|Patients received a placebo instead of Valsartan
711948|NCT00208767|O1|Outcome|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
711949|NCT00208767|E2|Reported Event|Placebo|Patients received a placebo instead of Valsartan
711950|NCT00208767|E1|Reported Event|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
711952|NCT00208507|B2|Baseline|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711953|NCT00208507|B1|Baseline|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711954|NCT00208507|P2|Participant Flow|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711955|NCT00208507|P1|Participant Flow|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711956|NCT00208507|O2|Outcome|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711957|NCT00208507|O1|Outcome|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711958|NCT00208507|E2|Reported Event|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711959|NCT00208507|E1|Reported Event|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
711960|NCT00208494|B3|Baseline|Total|Total of all reporting groups
711961|NCT00208494|B2|Baseline|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
711962|NCT00208494|B1|Baseline|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
711963|NCT00208494|P2|Participant Flow|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
711964|NCT00208494|P1|Participant Flow|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
711965|NCT00208494|O2|Outcome|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
711966|NCT00208494|O1|Outcome|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
711967|NCT00208494|E2|Reported Event|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
711968|NCT00208494|E1|Reported Event|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
711969|NCT00208325|B5|Baseline|Total|Total of all reporting groups
711970|NCT00208325|B4|Baseline|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711971|NCT00208325|B3|Baseline|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711972|NCT00208325|B2|Baseline|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711973|NCT00208325|B1|Baseline|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711974|NCT00208325|P4|Participant Flow|PFC Mobile Bearing PCL Retained|"Mobile bearing~P.F.C Sigma Mobile Bearing Total knee system: Orthopaedic implant for total knee replacement"
711975|NCT00208325|P3|Participant Flow|PFC Fixed Bearing PCL Retained|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
711976|NCT00208325|P2|Participant Flow|PFC Mobile Bearing PCL Sacrificed|"Mobile bearing~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711977|NCT00208325|P1|Participant Flow|PFC Fixed Bearing PCL Sacrificed|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
711978|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711979|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711980|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711981|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711982|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711983|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711984|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711985|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711986|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711987|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711988|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711989|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711990|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711991|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711992|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711993|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711994|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711995|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711996|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711997|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
711998|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
711999|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712000|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712001|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712002|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712003|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712004|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712005|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712006|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712007|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712008|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712009|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712010|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712153|NCT00207740|E2|Reported Event|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 wks to Wk 52
712011|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712012|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712013|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712014|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712015|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712016|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712017|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712018|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712019|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712020|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712021|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712022|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712023|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712024|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712025|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712026|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712027|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712028|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712029|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712030|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712031|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712032|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712033|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712034|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712035|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712036|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712037|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712038|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712039|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712040|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712041|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712042|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712154|NCT00207740|E1|Reported Event|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 wks from Wk 0 to Wk 52
712043|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712044|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712045|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712046|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712047|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712048|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712049|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712050|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712051|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712052|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712053|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712054|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712055|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712056|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712057|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712058|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712059|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712060|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712061|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712062|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712063|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712064|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712065|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712066|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712067|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712068|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712069|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712070|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712071|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712072|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712073|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712074|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712155|NCT00207727|B6|Baseline|Total|Total of all reporting groups
712350|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712075|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712076|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712077|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712078|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712079|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712080|NCT00208325|E4|Reported Event|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712081|NCT00208325|E3|Reported Event|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712082|NCT00208325|E2|Reported Event|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
712083|NCT00208325|E1|Reported Event|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
712084|NCT00208091|B1|Baseline|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
712085|NCT00208091|P1|Participant Flow|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
712086|NCT00208091|O1|Outcome|Post-injection Subjective Change|Subjective assessment 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
712087|NCT00208091|O2|Outcome|Note Errors, Post-injection|Note errors (related to errors in loudness) 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
712088|NCT00208091|O1|Outcome|Note Errors, Baseline|Note errors (related to errors in loudness) were calculated as a measure of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note loudness.
712089|NCT00208091|O2|Outcome|Note Errors (Related to Errors in Duration), Post-injection|Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
712090|NCT00208091|O1|Outcome|Note Errors (Related to Errors in Duration), Baseline|Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
712091|NCT00208091|E1|Reported Event|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
712092|NCT00208026|B1|Baseline|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
712093|NCT00208026|P1|Participant Flow|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
712094|NCT00208026|O1|Outcome|Pimecrolimus 1% Cream|"Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:~Pimecrolimus 1% Cream: Open label single arm"
712095|NCT00208026|E1|Reported Event|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
712096|NCT00207883|B3|Baseline|Total|Total of all reporting groups
712097|NCT00207883|B2|Baseline|Group 2 - US|ultra sound assisted CVC placement
712098|NCT00207883|B1|Baseline|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
712099|NCT00207883|P2|Participant Flow|Group 2 - Ultra Sound US|ultra sound assisted CVC placement
712100|NCT00207883|P1|Participant Flow|Group 1 - Traditional Anatomic Landmark- LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
712101|NCT00207883|O2|Outcome|Group 2 - US|ultra sound assisted CVC placement
712102|NCT00207883|O1|Outcome|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
712103|NCT00207883|O2|Outcome|Group 2 - US|ultra sound assisted CVC placement
712104|NCT00207883|O1|Outcome|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
712105|NCT00207883|E2|Reported Event|Group 2 - US|ultra sound assisted central line placement 10/118 (8.5%) had arterial puncture. None was considered serious.
712156|NCT00207727|B5|Baseline|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712106|NCT00207883|E1|Reported Event|Group 1 - LM|"traditional anatomic landmark central line placement utilizing palpation and the Seldinger technique.~18/93 (19.4%) had arterial puncture. None was considered serious."
712107|NCT00207740|B5|Baseline|Total|Total of all reporting groups
712108|NCT00207740|B4|Baseline|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712109|NCT00207740|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712110|NCT00207740|B2|Baseline|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712111|NCT00207740|B1|Baseline|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
712112|NCT00207740|P4|Participant Flow|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712113|NCT00207740|P3|Participant Flow|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712114|NCT00207740|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712115|NCT00207740|P1|Participant Flow|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
712116|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
712117|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712118|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712119|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712120|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
712121|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
712122|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712123|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712124|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712125|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
712126|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
712127|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712128|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712129|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712130|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
712131|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
712132|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712133|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712134|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712135|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
712136|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
712137|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712138|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712139|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712140|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
712141|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
712142|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712143|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712144|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712145|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
712146|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
712147|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
712148|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
712149|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
712150|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
712151|NCT00207740|E4|Reported Event|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 wks to Wk 52
712152|NCT00207740|E3|Reported Event|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 wks to Wk 52
712157|NCT00207727|B4|Baseline|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712158|NCT00207727|B3|Baseline|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
712159|NCT00207727|B2|Baseline|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712160|NCT00207727|B1|Baseline|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
712161|NCT00207727|P5|Participant Flow|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712162|NCT00207727|P4|Participant Flow|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712163|NCT00207727|P3|Participant Flow|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
712164|NCT00207727|P2|Participant Flow|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712165|NCT00207727|P1|Participant Flow|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
712166|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712167|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712168|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
712169|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712170|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
712171|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712172|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712173|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
712174|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712175|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
712176|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712177|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712178|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
712179|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712180|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
712181|NCT00207727|E5|Reported Event|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712182|NCT00207727|E4|Reported Event|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712183|NCT00207727|E3|Reported Event|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
712184|NCT00207727|E2|Reported Event|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
712185|NCT00207727|E1|Reported Event|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
712186|NCT00207714|B6|Baseline|Total|Total of all reporting groups
712187|NCT00207714|B5|Baseline|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
712188|NCT00207714|B4|Baseline|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
712189|NCT00207714|B3|Baseline|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
712190|NCT00207714|B2|Baseline|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
712239|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712191|NCT00207714|B1|Baseline|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
712192|NCT00207714|P5|Participant Flow|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
712193|NCT00207714|P4|Participant Flow|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
712194|NCT00207714|P3|Participant Flow|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
712195|NCT00207714|P2|Participant Flow|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
712196|NCT00207714|P1|Participant Flow|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
712197|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 wks).
712198|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
712199|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 wks thru Wk 18 plus MTX (Weeks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Weeks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
712200|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
712201|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
712202|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 wks from Wk 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 wks thru Wk 44. Continue stable dose of MTX throughout the study.
712203|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks).
712204|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
712205|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
712206|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
712207|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
712208|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
712209|NCT00207714|E5|Reported Event|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
712210|NCT00207714|E4|Reported Event|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
712211|NCT00207714|E3|Reported Event|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
712212|NCT00207714|E2|Reported Event|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
712213|NCT00207714|E1|Reported Event|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
712214|NCT00207142|B4|Baseline|Total|Total of all reporting groups
712215|NCT00207142|B3|Baseline|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712216|NCT00207142|B2|Baseline|Randomized Subjects: Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712217|NCT00207142|B1|Baseline|Randomized Subjects: Switch Regimen|ATV 400 mg QD + 2 NRTIs
712218|NCT00207142|P4|Participant Flow|Rescue Treatment|Participants without confirmed undetectable viral load at the end of Induction Phase were not randomized, but were offered to continue on ATV 300 mg + RTV 100 mg QD + 2 NRTIs for an additional 48 weeks (continued previous NRTI).
712219|NCT00207142|P3|Participant Flow|Maintenance Treatment: Continuation Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase) at the end of Induction Phase, who were then randomized to ATV 300 mg + RTV 100 mg QD for an additional 48 weeks (continued previous NRTI).
712220|NCT00207142|P2|Participant Flow|Maintenance Treatment: Switch Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase), at the end of Induction Phase, who were then randomized to ATV 400 mg QD for an additional 48 weeks (continued previous NRTI).
712221|NCT00207142|P1|Participant Flow|Induction Treatment|Atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg, given once daily (QD) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) during a 26- to 30-week Induction Phase
712222|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300mg + RTV 100mg QD + 2NRTIs
712223|NCT00207142|O1|Outcome|Switch Regimen|ATV 400mg QD + 2NRTIs
712224|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712225|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712226|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
712227|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712228|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712229|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712230|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
712231|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
712232|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
712233|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
712234|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712235|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712236|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712237|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712238|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712351|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712240|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712241|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712242|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712243|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
712244|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712245|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
712246|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712247|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
712248|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712249|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
712250|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712251|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
712252|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712253|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
712254|NCT00207142|E3|Reported Event|Non-Randomized Participants|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
712255|NCT00207142|E2|Reported Event|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
712256|NCT00207142|E1|Reported Event|Switch Regimen|ATV 400 mg QD + 2 NRTIs
712257|NCT00207090|B1|Baseline|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712258|NCT00207090|P1|Participant Flow|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712259|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712260|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
712261|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712262|NCT00207090|O1|Outcome|Ixabepilone + Rifampin|Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
712263|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712264|NCT00207090|O1|Outcome|All Participants|All participants who were enrolled into the study, 24 hours before ixabepilone administration on Day -1. Each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2 on Day 1 of Cycle 1. Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23 through 28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food during Cycle 2.
712265|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712266|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712267|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712268|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712269|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712270|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712271|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712272|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712273|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712274|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712352|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712353|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712275|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712276|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712277|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712278|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712279|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712280|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712281|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712282|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712283|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712284|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
712303|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
712285|NCT00207090|E1|Reported Event|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
712286|NCT00206726|B1|Baseline|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712287|NCT00206726|P1|Participant Flow|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712288|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712289|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712290|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712291|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712292|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712293|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712294|NCT00206726|E1|Reported Event|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
712295|NCT00206518|B3|Baseline|Total|Total of all reporting groups
712296|NCT00206518|B2|Baseline|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
712297|NCT00206518|B1|Baseline|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
712298|NCT00206518|P2|Participant Flow|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
712299|NCT00206518|P1|Participant Flow|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
712300|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
712301|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
712302|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
712304|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
712305|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
712306|NCT00206518|E2|Reported Event|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
712307|NCT00206518|E1|Reported Event|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
712308|NCT00206440|B3|Baseline|Total|Total of all reporting groups
712309|NCT00206440|B2|Baseline|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
712310|NCT00206440|B1|Baseline|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
712311|NCT00206440|P2|Participant Flow|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
712312|NCT00206440|P1|Participant Flow|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
712313|NCT00206440|O2|Outcome|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
712314|NCT00206440|O1|Outcome|Esomeprazole|The first dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
712315|NCT00206440|E2|Reported Event|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
712316|NCT00206440|E1|Reported Event|Esomeprazole|The frist dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
712317|NCT00206427|B1|Baseline|GW572016 1500mg|patients received GW572016 1500mg daily
712318|NCT00206427|P1|Participant Flow|GW572016 1500mg|The study had only 1 treatment group and all patient had GW572016 1500mg daily.
712319|NCT00206427|O1|Outcome|GW572016 1500mg|patients received GW572016 1500mg daily
712320|NCT00206427|E1|Reported Event|GW572016 1500mg|patients received GW572016 1500mg daily
712321|NCT00206336|B1|Baseline|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
712322|NCT00206336|P1|Participant Flow|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
712323|NCT00206336|O1|Outcome|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
712324|NCT00206336|E1|Reported Event|Topiramate|"Topiramate open label~Topiramate (drug): Topiramate 25 mg to 200 mg"
712325|NCT00206323|B3|Baseline|Total|Total of all reporting groups
712326|NCT00206323|B2|Baseline|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
712327|NCT00206323|B1|Baseline|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
712328|NCT00206323|P2|Participant Flow|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
712329|NCT00206323|P1|Participant Flow|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
712330|NCT00206323|O2|Outcome|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
712331|NCT00206323|O1|Outcome|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
712332|NCT00206323|E2|Reported Event|Topiramate|"Topiramate versus placebo~Topiramate (drug): Topiramate 25 mg titrated to 200 mg"
712333|NCT00206323|E1|Reported Event|Placebo/Sugar Pill|"Placebo or sugar pill~placebo/sugar pill: placebo"
712334|NCT00206102|B3|Baseline|Total|Total of all reporting groups
712335|NCT00206102|B2|Baseline|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712336|NCT00206102|B1|Baseline|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712337|NCT00206102|P2|Participant Flow|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712338|NCT00206102|P1|Participant Flow|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712339|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712340|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712341|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712342|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712343|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712344|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712345|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712346|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
719140|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
712354|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712355|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712356|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712357|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712358|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712359|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712360|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712361|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712362|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712363|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712364|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712365|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712366|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712367|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712368|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712369|NCT00206102|E2|Reported Event|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
712370|NCT00206102|E1|Reported Event|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
712371|NCT00206076|B3|Baseline|Total|Total of all reporting groups
712372|NCT00206076|B2|Baseline|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
712373|NCT00206076|B1|Baseline|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
712374|NCT00206076|P2|Participant Flow|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
712375|NCT00206076|P1|Participant Flow|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
712376|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
712377|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
712378|NCT00206076|O2|Outcome|CNI Reduction|calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment
712379|NCT00206076|O1|Outcome|CNI Discontinued|complete withdrawal of calcineurin inhibitors (CNI)
712380|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
712381|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
712382|NCT00206076|E2|Reported Event|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
712383|NCT00206076|E1|Reported Event|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
712384|NCT00205881|B1|Baseline|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
712385|NCT00205881|P1|Participant Flow|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
712386|NCT00205881|O2|Outcome|8 Months Post-device Activation|Testing conducted with bilateral implants.
712387|NCT00205881|O1|Outcome|Baseline|Testing with hearing aids in best-aided condition.
712388|NCT00205881|E1|Reported Event|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
712389|NCT00205855|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
712390|NCT00205855|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|"Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered trial durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System."
712391|NCT00205855|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
712392|NCT00205855|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
712393|NCT00205803|B3|Baseline|Total|Total of all reporting groups
712394|NCT00205803|B2|Baseline|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712395|NCT00205803|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712396|NCT00205803|P2|Participant Flow|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712397|NCT00205803|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
719141|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
712398|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712399|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712400|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712401|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712402|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712403|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712404|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712405|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712406|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712407|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712408|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
712409|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series).
712410|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712411|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712412|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712413|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712414|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712415|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712416|NCT00205803|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712417|NCT00205803|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712418|NCT00205803|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
712419|NCT00205803|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
712420|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712421|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712422|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712423|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712424|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712425|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712426|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
712427|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
712428|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
712429|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
712430|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
712431|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
712432|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
712433|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
712434|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
712435|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
712436|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
712437|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
712438|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
712439|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
712440|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
712441|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
712442|NCT00205803|E6|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712443|NCT00205803|E5|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
712444|NCT00205803|E4|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
712445|NCT00205803|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
712446|NCT00205803|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
712734|NCT00204932|O1|Outcome|Conjugated Linoleic Acid|3 grams per day for 7 months
712447|NCT00205803|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
712448|NCT00205777|B5|Baseline|Total|Total of all reporting groups
712449|NCT00205777|B4|Baseline|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712450|NCT00205777|B3|Baseline|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712451|NCT00205777|B2|Baseline|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712452|NCT00205777|B1|Baseline|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712453|NCT00205777|P6|Participant Flow|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712454|NCT00205777|P5|Participant Flow|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712455|NCT00205777|P4|Participant Flow|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712456|NCT00205777|P3|Participant Flow|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712457|NCT00205777|P2|Participant Flow|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712458|NCT00205777|P1|Participant Flow|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 milligram (mg) capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712459|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712460|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712461|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712462|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712463|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712464|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712465|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712466|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712467|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712468|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712469|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712470|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712471|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712735|NCT00204932|E2|Reported Event|Placebo|4 grams per day of sunflower oil for 6 months
712472|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712473|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712474|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712475|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712476|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712477|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712478|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712479|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712480|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712481|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712482|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712483|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712484|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712485|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712486|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712487|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712488|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712489|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712490|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712491|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712492|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712493|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712494|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712495|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712496|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712497|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712498|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712499|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712500|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712501|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712502|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712503|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712504|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712505|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712506|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712507|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712508|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712509|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712510|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712511|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712512|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712513|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712514|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712515|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712516|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712517|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712518|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712541|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712519|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712520|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712521|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712522|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712523|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712524|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712525|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712526|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712527|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712528|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712529|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712530|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712531|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712532|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712533|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712534|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712535|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712536|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712537|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712538|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712539|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712540|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712565|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712542|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712543|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712544|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712545|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712546|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712547|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712548|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712549|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712550|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712551|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712552|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712553|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712554|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712555|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712556|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712557|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712558|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712559|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712560|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712561|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712562|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712563|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712564|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712566|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712567|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712568|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712569|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712570|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712571|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712572|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712573|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712574|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712575|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712576|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712577|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712578|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712579|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712580|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712581|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712582|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712583|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712584|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712585|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712586|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712587|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712588|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712702|NCT00205504|E2|Reported Event|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
712589|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712590|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712591|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712592|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712593|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712594|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712595|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712596|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712597|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712598|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712599|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712600|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712601|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712602|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712603|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712604|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712605|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712606|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712607|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712608|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712609|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712610|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712732|NCT00204932|P1|Participant Flow|Conjugated Linoleic Acid|4 grams per day of 78% CLA for 6 months
712611|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712612|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712613|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712614|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712615|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712616|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712617|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712618|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712619|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712620|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712621|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712622|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712623|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712624|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712625|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712626|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712627|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712628|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712629|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712630|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712631|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712632|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712633|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
719142|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
712634|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712635|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712636|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712637|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712638|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712639|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712640|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712641|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712642|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712643|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712644|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712645|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712646|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712647|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712648|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712649|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712650|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712651|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712652|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712653|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712654|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712655|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712733|NCT00204932|O2|Outcome|Placebo|3 grams per day of sunflower oil for 7 months
712656|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712657|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712658|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712659|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
712660|NCT00205777|E4|Reported Event|Placebo|Matching placebo capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in the core study, study extension I and II.
712661|NCT00205777|E3|Reported Event|Raloxifene 60 mg (Core Study)|Raloxifene 60 mg capsule orally once daily in the core study along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712662|NCT00205777|E2|Reported Event|Bazedoxifene 40/ 20 mg|Bazedoxifene acetate 40 mg capsule orally once daily in the core study, in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, and II along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
712663|NCT00205777|E1|Reported Event|Bazedoxifene 20 mg|Bazedoxifene acetate 20 mg capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in core study, study extension I and II.
712664|NCT00205712|B3|Baseline|Total|Total of all reporting groups
712665|NCT00205712|B2|Baseline|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
712666|NCT00205712|B1|Baseline|Ketamine Alone|ketamine without dexmedetomidine
712667|NCT00205712|P2|Participant Flow|Ketamine Plus Dexmedetomidine|Ketamine infusion plus dexmedetomidine
712668|NCT00205712|P1|Participant Flow|Ketamine Alone|Ketamine without dexmedetomidine
712669|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
712670|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
712671|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
712672|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
712673|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
712674|NCT00205712|O1|Outcome|Ketamine Alone|ketamine without dexmedetomidine
712675|NCT00205712|E2|Reported Event|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
712676|NCT00205712|E1|Reported Event|Ketamine Alone|Ketamine without dexmedetomidine
712677|NCT00205504|B3|Baseline|Total|Total of all reporting groups
712678|NCT00205504|B2|Baseline|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
712679|NCT00205504|B1|Baseline|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
712680|NCT00205504|P2|Participant Flow|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
712681|NCT00205504|P1|Participant Flow|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
712682|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
712683|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
712684|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
712685|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
712686|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
712687|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
712688|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
712689|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
712690|NCT00205504|O2|Outcome|Lean Women|Women with BMI >25 kg/m²
712691|NCT00205504|O1|Outcome|Obese Women|Women with BMI >30 kg/m²
712692|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
712693|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
712694|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
712695|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
712696|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
712697|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
712698|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
712699|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
712700|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
712701|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
712703|NCT00205504|E1|Reported Event|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
712704|NCT00205374|B3|Baseline|Total|Total of all reporting groups
712705|NCT00205374|B2|Baseline|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712706|NCT00205374|B1|Baseline|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712707|NCT00205374|P2|Participant Flow|Placebo|The placebo treatment was injection of saline solution that had a color and viscosity identical to those of the active drug. Up to 6 injections per participant were given during the study.
712708|NCT00205374|P1|Participant Flow|Cidofovir|With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults. The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected. Because the volumes of cidofovir injected into the airway will be reasonably small (typically less than 2 mL), the total systemic dose of cidofovir administered per visit will be far below the FDA-approved systemic limit of 5 mg/kg for HIV-related CMV retinitis. No more than 6 treatments were performed per patient within the 12-month time interval of the study.
712709|NCT00205374|O2|Outcome|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712710|NCT00205374|O1|Outcome|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712711|NCT00205374|O2|Outcome|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712712|NCT00205374|O1|Outcome|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712713|NCT00205374|E2|Reported Event|Placebo|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712714|NCT00205374|E1|Reported Event|Cidofovir|On the baseline study day, patients will be randomized into either a treatment group (cidofovir injection) or a placebo group. A restricted randomization procedure, in groups of 4, will be used to encourage uniformity in sample sizes between groups.
712715|NCT00205348|B1|Baseline|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function."
712716|NCT00205348|P1|Participant Flow|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function."
712717|NCT00205348|O1|Outcome|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function. A score of 0 represents the least favorable state, and 100 the most favorable."
712718|NCT00205348|E1|Reported Event|SWAL-QOL Questionnaire|"Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.~Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function."
712719|NCT00205049|B3|Baseline|Total|Total of all reporting groups
712720|NCT00205049|B2|Baseline|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
712721|NCT00205049|B1|Baseline|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
712722|NCT00205049|P2|Participant Flow|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
712723|NCT00205049|P1|Participant Flow|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
712724|NCT00205049|O2|Outcome|Placebo|
712725|NCT00205049|O1|Outcome|Pentoxifylline|
712726|NCT00205049|E2|Reported Event|Placebo|
712727|NCT00205049|E1|Reported Event|Pentoxifylline|
712728|NCT00204932|B3|Baseline|Total|Total of all reporting groups
712729|NCT00204932|B2|Baseline|Placebo|3 grams per day of sunflower oil for 7 months
712730|NCT00204932|B1|Baseline|Conjugated Linoleic Acid|3 grams per day for 7 months
712731|NCT00204932|P2|Participant Flow|Placebo|4 grams per day of sunflower oil for 6 months
712736|NCT00204932|E1|Reported Event|Conjugated Linoleic Acid|4 grams of 78% active CLA per day for 6 months
712737|NCT00204373|B1|Baseline|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
712738|NCT00204373|P1|Participant Flow|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
712739|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
712740|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
712741|NCT00204373|E1|Reported Event|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
712742|NCT00203996|B7|Baseline|Total|Total of all reporting groups
712743|NCT00203996|B6|Baseline|Aim 3: All Participants|Includes groups randomized to any experimental ordering in Aim 3
712744|NCT00203996|B5|Baseline|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712745|NCT00203996|B4|Baseline|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712746|NCT00203996|B3|Baseline|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712747|NCT00203996|B2|Baseline|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712748|NCT00203996|B1|Baseline|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712749|NCT00203996|P10|Participant Flow|Aim 3: Baseline - SWS Supp - REM Frag|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed."
712750|NCT00203996|P9|Participant Flow|Aim 3: SWS Supp - REM Frag - Baseline|"Each subject was assessed under three experimental conditions in the following order.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
712751|NCT00203996|P8|Participant Flow|Aim 3: Baseline - REM Frag - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
712752|NCT00203996|P7|Participant Flow|Aim 3: REM Frag - Baseline - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
712753|NCT00203996|P6|Participant Flow|Aim 3: REM Frag - SWS Supp - Baseline|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
712754|NCT00203996|P5|Participant Flow|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712755|NCT00203996|P4|Participant Flow|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712756|NCT00203996|P3|Participant Flow|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712757|NCT00203996|P2|Participant Flow|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712758|NCT00203996|P1|Participant Flow|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712854|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
712759|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
712760|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
712761|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
712762|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
712763|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712764|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712765|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712766|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712767|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712768|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712769|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712770|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712771|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712772|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712773|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712774|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712775|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712776|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712777|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712778|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712779|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712780|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712781|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712782|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712783|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712784|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712785|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712786|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712787|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712788|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712789|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712790|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712791|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712792|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712793|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712794|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712795|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712796|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712797|NCT00203996|E7|Reported Event|Aim 3: SWS Suppression|SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
712798|NCT00203996|E6|Reported Event|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
712799|NCT00203996|E5|Reported Event|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
712800|NCT00203996|E4|Reported Event|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
712801|NCT00203996|E3|Reported Event|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
712802|NCT00203996|E2|Reported Event|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
712803|NCT00203996|E1|Reported Event|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
712804|NCT00203931|B3|Baseline|Total|Total of all reporting groups
712805|NCT00203931|B2|Baseline|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
712806|NCT00203931|B1|Baseline|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
712807|NCT00203931|P2|Participant Flow|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
712808|NCT00203931|P1|Participant Flow|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
712809|NCT00203931|O2|Outcome|Good Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
712810|NCT00203931|O1|Outcome|Poor Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
712811|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
712812|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
712813|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
712814|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
712815|NCT00203931|O2|Outcome|No Early Rash|Absence of rash (grade 1 or higher) by day 21 of cetuximab therapy
712816|NCT00203931|O1|Outcome|Early Rash|Presence of rash (grade 1 or higher) by day 21 of cetuximab therapy
712817|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
712818|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
712819|NCT00203931|E2|Reported Event|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
712820|NCT00203931|E1|Reported Event|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
712821|NCT00203892|B4|Baseline|Total|Total of all reporting groups
712822|NCT00203892|B3|Baseline|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712823|NCT00203892|B2|Baseline|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712824|NCT00203892|B1|Baseline|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712825|NCT00203892|P3|Participant Flow|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
719143|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
712826|NCT00203892|P2|Participant Flow|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712827|NCT00203892|P1|Participant Flow|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712828|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712829|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712830|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712831|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712832|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712833|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712834|NCT00203892|E3|Reported Event|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712835|NCT00203892|E2|Reported Event|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712836|NCT00203892|E1|Reported Event|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
712837|NCT00203502|B1|Baseline|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712838|NCT00203502|P1|Participant Flow|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712839|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712840|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712841|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712842|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712843|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712844|NCT00203502|E1|Reported Event|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
712845|NCT00203476|B4|Baseline|Total|Total of all reporting groups
712846|NCT00203476|B3|Baseline|Ezetimibe|Ezetimibe added to max tolerated dose statin
712847|NCT00203476|B2|Baseline|Colestipol|Colestipol added to max dose statin
712848|NCT00203476|B1|Baseline|Niacin|Niacin added to max tolerated dose of statin
712849|NCT00203476|P3|Participant Flow|Ezetimibe|Ezetimibe added to max tolerated dose statin
712850|NCT00203476|P2|Participant Flow|Colestipol|Colestipol added to max dose statin
712851|NCT00203476|P1|Participant Flow|Niacin|Niacin added to max tolerated dose of statin
712852|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
712853|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
712855|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
712856|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
712857|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
712858|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
712859|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
712860|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
712861|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
712862|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
712863|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
712864|NCT00203476|E3|Reported Event|Ezetimibe|Ezetimibe added to max tolerated dose statin
712865|NCT00203476|E2|Reported Event|Colestipol|Colestipol added to max dose statin
712866|NCT00203476|E1|Reported Event|Niacin|Niacin added to max tolerated dose of statin
712867|NCT00203424|B1|Baseline|Erlotinib + Bevacizumab|Participants that entered treatment period.
712868|NCT00203424|P1|Participant Flow|Erlotinib + Bevacizumab|27 participants were screened for the study. 4 did not meet eligibility criteria,23 were registered to treatment period. 1 withdrew consent a day after registration and did not initiate study treatment.22 participants entered treatment period. Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses. The protocol instructed that pts be treated for 6 cycles. Of the 22 pts that started treatment, 11 completed the 6 cycles and the other 11 had to stop treatment prior to administration of 6th cycle. Of the 11 pts that did not complete all 6 cycles, 5 stopped treatment due to adverse event and were entered into the follow-up period. The 6 that stopped treatment due to withdrawal of consent and progressive disease did not enter the follow-up period. So 11 pts that completed 6 cycles of treatment plus 5 pts that did not complete 6 cycles of treatment due to an adverse event gives a total of 16 patients who entered follow-up period.
712869|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
712870|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
712871|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
712872|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
712873|NCT00203424|E1|Reported Event|Erlotinib + Bevacizumab|Participants that entered treatment period.
712874|NCT00203411|B1|Baseline|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
712875|NCT00203411|P1|Participant Flow|Bevacizumab Plus Capecitabine|"Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.~Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period~Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks"
712876|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
712877|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
712878|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
712879|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
712880|NCT00203411|E1|Reported Event|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
712881|NCT00203307|B3|Baseline|Total|Total of all reporting groups
712882|NCT00203307|B2|Baseline|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
712883|NCT00203307|B1|Baseline|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
712884|NCT00203307|P2|Participant Flow|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
712885|NCT00203307|P1|Participant Flow|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
712886|NCT00203307|O2|Outcome|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
712887|NCT00203307|O1|Outcome|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
712888|NCT00203307|E2|Reported Event|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
712889|NCT00203307|E1|Reported Event|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
712890|NCT00203294|B3|Baseline|Total|Total of all reporting groups
719144|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
712891|NCT00203294|B2|Baseline|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
712892|NCT00203294|B1|Baseline|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
712893|NCT00203294|P2|Participant Flow|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
712894|NCT00203294|P1|Participant Flow|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
712895|NCT00203294|O2|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg.|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
712896|NCT00203294|O1|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Saline|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
712897|NCT00203294|E2|Reported Event|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
712898|NCT00203294|E1|Reported Event|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
712899|NCT00203268|B1|Baseline|Treatment Group|Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
712900|NCT00203268|P1|Participant Flow|Treatment Group|Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
712901|NCT00203268|O2|Outcome|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
712902|NCT00203268|O1|Outcome|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
712903|NCT00203268|E2|Reported Event|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
712904|NCT00203268|E1|Reported Event|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
712905|NCT00203242|B1|Baseline|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
712906|NCT00203242|P1|Participant Flow|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
712907|NCT00203242|O1|Outcome|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
712908|NCT00203242|E1|Reported Event|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
712909|NCT00203229|B3|Baseline|Total|Total of all reporting groups
712910|NCT00203229|B2|Baseline|Lamotrigine|The intervention type is 'drug' and this arm is the active drug created and supplied by the manufacturers of lamotrigine (Lamictal). This is an anti-seizure medication.
712911|NCT00203229|B1|Baseline|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
712912|NCT00203229|P2|Participant Flow|Lamotrigine|The intervention type is 'drug' and this arm is the active drug supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. This drug is an anti-seizure medication.
712913|NCT00203229|P1|Participant Flow|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
712914|NCT00203229|O2|Outcome|Lamotrigine|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
712915|NCT00203229|O1|Outcome|Placebo|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
712916|NCT00203229|E2|Reported Event|Lamotrigine|Subjects who received Lamotrigine
712917|NCT00203229|E1|Reported Event|Placebo|Subjects who received placebo
712918|NCT00203216|B1|Baseline|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
712919|NCT00203216|P1|Participant Flow|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
712920|NCT00203216|O1|Outcome|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
712921|NCT00203216|E1|Reported Event|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
712922|NCT00203203|B3|Baseline|Total|Total of all reporting groups
712923|NCT00203203|B2|Baseline|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712924|NCT00203203|B1|Baseline|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712925|NCT00203203|P2|Participant Flow|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712926|NCT00203203|P1|Participant Flow|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712927|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712928|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712929|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712930|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712931|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712932|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712933|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712934|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712935|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712936|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712937|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712938|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712939|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712940|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712941|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712942|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712943|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712944|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712945|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712946|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712947|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712948|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712949|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
713045|NCT00202449|E2|Reported Event|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
712950|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712951|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712952|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712953|NCT00203203|E2|Reported Event|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
712954|NCT00203203|E1|Reported Event|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
712955|NCT00203047|B3|Baseline|Total|Total of all reporting groups
712956|NCT00203047|B2|Baseline|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
712957|NCT00203047|B1|Baseline|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
712958|NCT00203047|P2|Participant Flow|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
712959|NCT00203047|P1|Participant Flow|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
712960|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
712961|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
712962|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
712963|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
712964|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
712965|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
712966|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
712967|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
712968|NCT00203047|E2|Reported Event|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
712969|NCT00203047|E1|Reported Event|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
712970|NCT00202878|B3|Baseline|Total|Total of all reporting groups
712971|NCT00202878|B2|Baseline|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
712972|NCT00202878|B1|Baseline|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
712973|NCT00202878|P2|Participant Flow|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
712974|NCT00202878|P1|Participant Flow|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
712975|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
712976|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
712977|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
712978|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
712979|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
712980|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
712981|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
712982|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
712983|NCT00202878|E2|Reported Event|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
712984|NCT00202878|E1|Reported Event|Ezetimide/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
712985|NCT00202839|B3|Baseline|Total|Total of all reporting groups
712986|NCT00202839|B2|Baseline|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
712987|NCT00202839|B1|Baseline|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
712988|NCT00202839|P2|Participant Flow|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
712989|NCT00202839|P1|Participant Flow|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
713334|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
712990|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
712991|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
712992|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
712993|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
712994|NCT00202839|E2|Reported Event|48-Week Treatment|
712995|NCT00202839|E1|Reported Event|24-Week Treatment|
712996|NCT00202722|B1|Baseline|Women in Labour Given Remifentanil Analgesia|Administration of remifentanil analgesia startet with cervical dilatation > 4 cm
712997|NCT00202722|P1|Participant Flow|Effect and Side Effects of Remifentanil|Analgesic efficacy and side offects of remifentanil during labour and delivery
712998|NCT00202722|O1|Outcome|Satisfaction With Remifentanil Analgesia|Patient satisfaction with remifentanil pain relief by use of questionnaire (within 24-hours after delivery)
712999|NCT00202722|O1|Outcome|Remifentanil|"Pain scores~Satisfaction"
713000|NCT00202722|E1|Reported Event|Maternal Oxygen Desaturation|Oxygen saturation lower than 92% during labour and delivery
713001|NCT00202644|B3|Baseline|Total|Total of all reporting groups
713002|NCT00202644|B2|Baseline|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713003|NCT00202644|B1|Baseline|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713004|NCT00202644|P2|Participant Flow|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713005|NCT00202644|P1|Participant Flow|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713006|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713007|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713008|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713009|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713010|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713011|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713012|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713013|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713014|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713015|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713016|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713017|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713018|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713019|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713020|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713021|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713022|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713023|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713024|NCT00202644|O2|Outcome|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713025|NCT00202644|O1|Outcome|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713026|NCT00202644|E2|Reported Event|Hydroxyurea|Participants received Hydroxyurea as 1000 mg per day administered orally as 500 mg capsule twice daily and dose titrated to effect to achieve a response. Participants followed for up to 3 years.
713027|NCT00202644|E1|Reported Event|Anagrelide|Participants received Anagrelide hydrochloride 1.0 milligram (mg) per day administered orally as 0.5 mg capsule twice daily (bid) for 1 week. Then the dose was titrated such that the total daily dose is incremented by no more than 0.5 mg in any 1 week and the recommended maximum single dose could not exceed 2.5 mg as required depending on platelet reduction versus adverse event profile. Total daily dosage was not exceed 10 mg. Participants followed for up to 3 years.
713028|NCT00202449|B4|Baseline|Total|Total of all reporting groups
713029|NCT00202449|B3|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
713030|NCT00202449|B2|Baseline|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
713031|NCT00202449|B1|Baseline|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
713032|NCT00202449|P3|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
713033|NCT00202449|P2|Participant Flow|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
713034|NCT00202449|P1|Participant Flow|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
713035|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
713036|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
713037|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
713038|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
713039|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
713040|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
713041|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
713042|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
713043|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
713044|NCT00202449|E3|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
713046|NCT00202449|E1|Reported Event|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
713047|NCT00201877|B1|Baseline|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
713048|NCT00201877|P1|Participant Flow|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
713049|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14~Velcade: Induction: 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13 & 14.~Maintenance: 1.3 mg/m2 IV day 1 weekly x 2 weeks beginning week 20 and continuing every 6 months until month 23.~Rituximab: Induction: 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13 and 14 prior to Velcade administration.~Maintenance: 375 mg/m2 day 1 weekly x 4 weeks."
713050|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
713051|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
713052|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
713053|NCT00201877|E1|Reported Event|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
713054|NCT00201864|B1|Baseline|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
713055|NCT00201864|P1|Participant Flow|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
713056|NCT00201864|O2|Outcome|IGFBP-3|IGFBP-3-insulin-like growth factor-binding
713057|NCT00201864|O1|Outcome|IGF-1|IGF-1-insulin-like growth factor
713058|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
713059|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
713060|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
713061|NCT00201864|E1|Reported Event|Single-arm Study|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
713062|NCT00201851|B4|Baseline|Total|Total of all reporting groups
713063|NCT00201851|B3|Baseline|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713064|NCT00201851|B2|Baseline|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713065|NCT00201851|B1|Baseline|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713066|NCT00201851|P3|Participant Flow|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713067|NCT00201851|P2|Participant Flow|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713068|NCT00201851|P1|Participant Flow|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713095|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
713335|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713069|NCT00201851|O3|Outcome|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713070|NCT00201851|O2|Outcome|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713071|NCT00201851|O1|Outcome|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713072|NCT00201851|E3|Reported Event|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713073|NCT00201851|E2|Reported Event|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713074|NCT00201851|E1|Reported Event|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
713075|NCT00201838|B3|Baseline|Total|Total of all reporting groups
713076|NCT00201838|B2|Baseline|Control Arm|Patients received Gemcitabine alone
713077|NCT00201838|B1|Baseline|Interventional Arm|Patients received Etanercept with gemcitabine
713078|NCT00201838|P2|Participant Flow|Control Group|Patients received gemcitabine alone
713079|NCT00201838|P1|Participant Flow|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
713080|NCT00201838|O2|Outcome|Non Responders|"Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
713081|NCT00201838|O1|Outcome|Responders|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
713082|NCT00201838|O2|Outcome|Control Group|gemcitabine alone
713083|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
713084|NCT00201838|O2|Outcome|Control Group|Gemcitabine alone
713085|NCT00201838|O1|Outcome|Experimental Group|Etanercept with gemcitabine
713086|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
713087|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
713088|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
713089|NCT00201838|O1|Outcome|Experimental Group|Patients received etanercept 25mg subcutaneously twice-weekly with gemcitabine
713090|NCT00201838|E2|Reported Event|Control Group|Patients in the control cohort received gemcitabine alone.
713091|NCT00201838|E1|Reported Event|Experimental Group|Patients in the experimental group received etancercept 25 mg subcutaneously twice-weekly with gemcitabine.
713092|NCT00201825|B1|Baseline|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
713093|NCT00201825|P1|Participant Flow|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
713094|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
713329|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713096|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
713097|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
713098|NCT00201825|E1|Reported Event|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
713099|NCT00201773|B1|Baseline|Exemestane & Celecoxib|"Patients will received exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day and instructed to take the drug with food.~Correlative studies"
713100|NCT00201773|P1|Participant Flow|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
713101|NCT00201773|O1|Outcome|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
713102|NCT00201773|O2|Outcome|Exemestane|Exemestane (8 weeks) vs. Baseline
713103|NCT00201773|O1|Outcome|Exemestane + Celecoxib|Exemestane + celecoxib (16 weeks) vs. Baseline
713104|NCT00201773|E2|Reported Event|Exemestane + Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
713105|NCT00201773|E1|Reported Event|Exemestane Alone|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
713106|NCT00201760|B3|Baseline|Total|Total of all reporting groups
713107|NCT00201760|B2|Baseline|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
713108|NCT00201760|B1|Baseline|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
713109|NCT00201760|P2|Participant Flow|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
713110|NCT00201760|P1|Participant Flow|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
713111|NCT00201760|O2|Outcome|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
713112|NCT00201760|O1|Outcome|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
713330|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713113|NCT00201760|O2|Outcome|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
713114|NCT00201760|O1|Outcome|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
713115|NCT00201760|O2|Outcome|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
713116|NCT00201760|O1|Outcome|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
713117|NCT00201760|E2|Reported Event|Arm 2 Gemcitabine / Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly."
713118|NCT00201760|E1|Reported Event|Arm 1 Gemcitabine/Cisplatin/Trastuzumab|"Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only).~Gemcitabine: 1000 mg/m2 IV over 30 minutes on Days 1 and 8.~Trastuzumab: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly.~Cisplatin: 30 mg/m2 IV on Day 1 and Day 8."
713119|NCT00201734|B3|Baseline|Total|Total of all reporting groups
713120|NCT00201734|B2|Baseline|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713121|NCT00201734|B1|Baseline|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713122|NCT00201734|P2|Participant Flow|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713123|NCT00201734|P1|Participant Flow|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713124|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713125|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713126|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713127|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713128|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713129|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713130|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713131|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713132|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713133|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713134|NCT00201734|O1|Outcome|Phase I Patients|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713135|NCT00201734|E2|Reported Event|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
713136|NCT00201734|E1|Reported Event|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
713137|NCT00201643|B3|Baseline|Total|Total of all reporting groups
713138|NCT00201643|B2|Baseline|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713139|NCT00201643|B1|Baseline|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713140|NCT00201643|P2|Participant Flow|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713141|NCT00201643|P1|Participant Flow|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713142|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713143|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713144|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713145|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713146|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713147|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713148|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713149|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713150|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713151|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713152|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713153|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713154|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713155|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
719145|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
713156|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713157|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713158|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713159|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713160|NCT00201643|E2|Reported Event|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
713161|NCT00201643|E1|Reported Event|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
713162|NCT00201448|B3|Baseline|Total|Total of all reporting groups
713163|NCT00201448|B2|Baseline|Towne CMV Vaccine|
713164|NCT00201448|B1|Baseline|Placebo (Hepatitis A)|
713165|NCT00201448|P2|Participant Flow|Towne CMV Vaccine|
713166|NCT00201448|P1|Participant Flow|Placebo (Hepatitis A)|
713167|NCT00201448|O2|Outcome|Towne Vaccine|"Towne vaccine given at 3000 pfu/subject~Towne CMV Vaccine: Single dose given subcutaneously"
713168|NCT00201448|O1|Outcome|Placebo (Hepatitis A)|"Placebo group~Hepatitis A Vaccine: Single dose give IM"
713169|NCT00201448|O2|Outcome|Towne CMV Vaccine|
713170|NCT00201448|O1|Outcome|(Placebo) Hepatitis a|This is the comparator group.
713171|NCT00201448|E2|Reported Event|Towne CMV Vaccine|
713172|NCT00201448|E1|Reported Event|Placebo (Hepatitis A)|
713173|NCT00201409|B3|Baseline|Total|Total of all reporting groups
713174|NCT00201409|B2|Baseline|Placebo Group|Participants will be randomized to receive placebo.
713175|NCT00201409|B1|Baseline|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
713176|NCT00201409|P2|Participant Flow|Placebo Group|Participants will be randomized to receive placebo.
713177|NCT00201409|P1|Participant Flow|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
713178|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
713179|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
713180|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
713181|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
713182|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
713183|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
713184|NCT00201409|E2|Reported Event|Placebo Group|Participants will be randomized to receive placebo.
713185|NCT00201409|E1|Reported Event|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
713186|NCT00201240|B1|Baseline|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713187|NCT00201240|P1|Participant Flow|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
713188|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713189|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
713190|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713191|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713192|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713193|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713194|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713195|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713196|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713197|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713198|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713199|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713200|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713201|NCT00201240|E1|Reported Event|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
713202|NCT00201201|B3|Baseline|Total|Total of all reporting groups
713203|NCT00201201|B2|Baseline|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713204|NCT00201201|B1|Baseline|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program."
713205|NCT00201201|P2|Participant Flow|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713206|NCT00201201|P1|Participant Flow|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
713207|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713208|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
713209|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713210|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
713211|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713212|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
713213|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713214|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
713215|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713216|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
713217|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
713331|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713218|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
713219|NCT00201201|E2|Reported Event|Control|Control group without education intervention.
713220|NCT00201201|E1|Reported Event|Education|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension will be randomized to usual care and intervention groups. Both groups will enter medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The intervention group will receive a tailored education program."
713221|NCT00201123|B4|Baseline|Total|Total of all reporting groups
713222|NCT00201123|B3|Baseline|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
713223|NCT00201123|B2|Baseline|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
713224|NCT00201123|B1|Baseline|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
713225|NCT00201123|P3|Participant Flow|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
713226|NCT00201123|P2|Participant Flow|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
713227|NCT00201123|P1|Participant Flow|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
713228|NCT00201123|O3|Outcome|Subcutaneous rlFN-y|
713229|NCT00201123|O2|Outcome|Nebulized rlFN-y|
713230|NCT00201123|O1|Outcome|DOTS|
713231|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
713232|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
713233|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
713234|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
713235|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
713236|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
713237|NCT00201123|E3|Reported Event|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
713238|NCT00201123|E2|Reported Event|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
713239|NCT00201123|E1|Reported Event|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
713240|NCT00201006|B4|Baseline|Total|Total of all reporting groups
713241|NCT00201006|B3|Baseline|Mail Contact|26 biweekly newsletters with weight management advice
713242|NCT00201006|B2|Baseline|Telephone Counseling|26 biweekly telephone counseling sessions
713243|NCT00201006|B1|Baseline|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
713244|NCT00201006|P3|Participant Flow|Mail Contact|26 biweekly newsletters with weight management advice
713245|NCT00201006|P2|Participant Flow|Telephone Counseling|26 biweekly telephone counseling sessions
713246|NCT00201006|P1|Participant Flow|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
713247|NCT00201006|O3|Outcome|Mail Contact|26 biweekly newsletters with weight management advice
713248|NCT00201006|O2|Outcome|Telephone Counseling|26 biweekly telephone counseling sessions
713249|NCT00201006|O1|Outcome|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
713250|NCT00201006|E3|Reported Event|Mail|received by mail 26 biweekly newsletters with weight management information
713251|NCT00201006|E2|Reported Event|Telephone|received 26 biweekly individual telephone counseling sessions
713252|NCT00201006|E1|Reported Event|Face-to-face|received 26 biweekly office-based, face-to-face group counseling sessions
713253|NCT00200967|B3|Baseline|Total|Total of all reporting groups
713254|NCT00200967|B2|Baseline|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713255|NCT00200967|B1|Baseline|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713256|NCT00200967|P2|Participant Flow|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713257|NCT00200967|P1|Participant Flow|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713258|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713259|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713260|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713261|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713262|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713263|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713264|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713265|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713266|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713267|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713268|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713269|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713270|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713271|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713272|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713273|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713274|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713275|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713276|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713277|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713278|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713279|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713280|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713332|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713333|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713281|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713282|NCT00200967|E2|Reported Event|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713283|NCT00200967|E1|Reported Event|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
713284|NCT00200785|B3|Baseline|Total|Total of all reporting groups
713285|NCT00200785|B2|Baseline|Garlic Powder: No Allicin|garlic powder in boiling water
713286|NCT00200785|B1|Baseline|Garlic Powder: High Allicin|garlic powder in ambient water
713287|NCT00200785|P2|Participant Flow|Garlic Powder: No Allicin|garlic powder in boiling water
713288|NCT00200785|P1|Participant Flow|Garlic Powder: High Allicin|garlic powder in ambient water
713289|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
713290|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
713291|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
713292|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
713293|NCT00200785|E2|Reported Event|Garlic Powder: No Allicin|garlic powder in boiling water
713294|NCT00200785|E1|Reported Event|Garlic Powder: High Allicin|garlic powder in ambient water
713295|NCT00200356|B3|Baseline|Total|Total of all reporting groups
713296|NCT00200356|B2|Baseline|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713297|NCT00200356|B1|Baseline|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713298|NCT00200356|P2|Participant Flow|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713299|NCT00200356|P1|Participant Flow|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713300|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713301|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713302|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713303|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713304|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713305|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713306|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713307|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713308|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713309|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713310|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713311|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713312|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713313|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713314|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713315|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713316|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713317|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713318|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713319|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713320|NCT00200356|E2|Reported Event|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
713321|NCT00200356|E1|Reported Event|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
713322|NCT00200343|B4|Baseline|Total|Total of all reporting groups
713323|NCT00200343|B3|Baseline|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713324|NCT00200343|B2|Baseline|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713325|NCT00200343|B1|Baseline|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713326|NCT00200343|P3|Participant Flow|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713327|NCT00200343|P2|Participant Flow|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713328|NCT00200343|P1|Participant Flow|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713336|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713337|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713338|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713339|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713340|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713341|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713342|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713343|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713344|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713345|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713346|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713347|NCT00200343|E3|Reported Event|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
713348|NCT00200343|E2|Reported Event|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
713349|NCT00200343|E1|Reported Event|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
713350|NCT00200161|B3|Baseline|Total|Total of all reporting groups
713351|NCT00200161|B2|Baseline|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713352|NCT00200161|B1|Baseline|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713353|NCT00200161|P2|Participant Flow|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713354|NCT00200161|P1|Participant Flow|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713355|NCT00200161|O2|Outcome|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713356|NCT00200161|O1|Outcome|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713357|NCT00200161|O2|Outcome|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713358|NCT00200161|O1|Outcome|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713359|NCT00200161|O2|Outcome|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713360|NCT00200161|O1|Outcome|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713400|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
713401|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
713361|NCT00200161|O2|Outcome|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713362|NCT00200161|O1|Outcome|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713363|NCT00200161|E2|Reported Event|Dose-Dense Therapy Cohort|"Concurrent temozolomide and radiotherapy plus high dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713364|NCT00200161|E1|Reported Event|Metronomic Therapy Cohort|"Concurrent temozolomide and radiotherapy plus lose dose of temozolomide~Temozolomide: Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression."
713365|NCT00200057|B1|Baseline|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713366|NCT00200057|P1|Participant Flow|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713367|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713368|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713369|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713370|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713371|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713372|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713373|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713374|NCT00200057|E1|Reported Event|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
713375|NCT00199914|B3|Baseline|Total|Total of all reporting groups
713376|NCT00199914|B2|Baseline|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713377|NCT00199914|B1|Baseline|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713378|NCT00199914|P2|Participant Flow|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713379|NCT00199914|P1|Participant Flow|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713380|NCT00199914|O2|Outcome|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713381|NCT00199914|O1|Outcome|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713382|NCT00199914|E2|Reported Event|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713383|NCT00199914|E1|Reported Event|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
713384|NCT00199381|B1|Baseline|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
713385|NCT00199381|P1|Participant Flow|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
713386|NCT00199381|O1|Outcome|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
713387|NCT00199381|E1|Reported Event|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
713388|NCT00198822|B4|Baseline|Total|Total of all reporting groups
713389|NCT00198822|B3|Baseline|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
713390|NCT00198822|B2|Baseline|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
713391|NCT00198822|B1|Baseline|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
713392|NCT00198822|P3|Participant Flow|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
713393|NCT00198822|P2|Participant Flow|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
713394|NCT00198822|P1|Participant Flow|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
713395|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
713396|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
713397|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
713398|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
713399|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
713402|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
713403|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
713404|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
713405|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
713406|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
713407|NCT00198822|E3|Reported Event|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
713408|NCT00198822|E2|Reported Event|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
713409|NCT00198822|E1|Reported Event|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
713410|NCT00198133|B3|Baseline|Total|Total of all reporting groups
713411|NCT00198133|B2|Baseline|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713412|NCT00198133|B1|Baseline|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713413|NCT00198133|P2|Participant Flow|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713414|NCT00198133|P1|Participant Flow|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713415|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713416|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713417|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713418|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713419|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713420|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713421|NCT00198133|E2|Reported Event|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713422|NCT00198133|E1|Reported Event|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
713423|NCT00198081|B3|Baseline|Total|Total of all reporting groups
713424|NCT00198081|B2|Baseline|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
713425|NCT00198081|B1|Baseline|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713426|NCT00198081|P2|Participant Flow|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
713427|NCT00198081|P1|Participant Flow|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713428|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713429|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713430|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713431|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713432|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713433|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713434|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713435|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713436|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713437|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713438|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713439|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713440|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713441|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713442|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713443|NCT00198081|O2|Outcome|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
713444|NCT00198081|O1|Outcome|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713445|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713446|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713447|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713448|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713449|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713450|NCT00198081|E2|Reported Event|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
713451|NCT00198081|E1|Reported Event|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
713452|NCT00198042|B1|Baseline|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
713453|NCT00198042|P1|Participant Flow|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
713454|NCT00198042|O1|Outcome|All Patients|Tunnel expansion after ACL-R occurs early and primarily at the tunnel apertures. Expansion may not affect clinical outcome. Younger age, male sex, and delay from injury to ACL-R may be potential risks for enlargement.
713455|NCT00198042|E1|Reported Event|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
713456|NCT00198029|B1|Baseline|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
713457|NCT00198029|P1|Participant Flow|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
713458|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
713459|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
713460|NCT00198029|E1|Reported Event|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
713461|NCT00197496|B3|Baseline|Total|Total of all reporting groups
713462|NCT00197496|B2|Baseline|Control|Usual care
713463|NCT00197496|B1|Baseline|BWSTT|Body weight supported treadmill training
713464|NCT00197496|P2|Participant Flow|Control|Usual care
713465|NCT00197496|P1|Participant Flow|BWSTT|Body weight supported treadmill training
713466|NCT00197496|O2|Outcome|Control|Usual care
713467|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
713468|NCT00197496|O2|Outcome|Control|Usual care
713469|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
713470|NCT00197496|O2|Outcome|Control|Usual care
713471|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
713472|NCT00197496|O2|Outcome|Control|Usual care
713473|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
713474|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
713475|NCT00197496|E2|Reported Event|Usual Care|Usual care rehabilitation
713476|NCT00197496|E1|Reported Event|BWSTT|Body weight supported treadmill training: hip fracture patients walk on a treadmill with body weight support
713477|NCT00197392|B3|Baseline|Total|Total of all reporting groups
713478|NCT00197392|B2|Baseline|Standard EVD|
713479|NCT00197392|B1|Baseline|Bactiseal EVD|
713480|NCT00197392|P2|Participant Flow|Conventional EVD Catheter|Subjects treated with Standard EVD catheter
713481|NCT00197392|P1|Participant Flow|Bactiseal EVD|Subjects treated with Bactiseal EVD catheter
713482|NCT00197392|O2|Outcome|Standard EVD|Subjects implanted with Standard EVD catheters.
713483|NCT00197392|O1|Outcome|Bactiseal EVD|Subjects implanted with Bactiseal EVD catheters.
713484|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
713485|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
713486|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
713487|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with the Bactiseal EVD Catheter
713488|NCT00197392|O2|Outcome|Standrad EVD Catheter|Subjects implanted with standard EVD catheter
713489|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
713490|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects treated with standard EVD catheter
713491|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects treated with Bactiseal EVD Catheter
713492|NCT00197392|O1|Outcome|Bactiseal EVD Catheter and Standard EVD Cathter|Patients implanted with Bactiseal EVD Catheter or Standard EVD Catheter.
713493|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with standard EVD catheter
713494|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
713495|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
713496|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
713497|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with standard EVD catheter
713498|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
713499|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
713500|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
713501|NCT00197392|O2|Outcome|Standard EVD Catheter|Patient treated with Standard EVD Catheter
713502|NCT00197392|O1|Outcome|Bactiseal - EVD Catheter|Patients treated with Bactiseal EVD catheter
713503|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients treated with standard EVD catheter.
713504|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
713505|NCT00197392|O2|Outcome|Standard EVD Cathter|Patients treated with Standard EVD Catheter
713506|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
713507|NCT00197392|E2|Reported Event|Bactiseal EVD|Subjects with Bactiseal EVD
713508|NCT00197392|E1|Reported Event|Standard EVD|Subjects with standard EVD
713509|NCT00197236|B4|Baseline|Total|Total of all reporting groups
713510|NCT00197236|B3|Baseline|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713511|NCT00197236|B2|Baseline|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713512|NCT00197236|B1|Baseline|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713513|NCT00197236|P3|Participant Flow|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713514|NCT00197236|P2|Participant Flow|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713515|NCT00197236|P1|Participant Flow|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713516|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713517|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713518|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713519|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713520|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713521|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713522|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713523|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713524|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713525|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713526|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713527|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713528|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713529|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713530|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713531|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713532|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713533|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713534|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713535|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713536|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713537|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713538|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713539|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713540|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713541|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713542|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713543|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713544|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713545|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713546|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713547|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713548|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713549|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713550|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713551|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713552|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713553|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713554|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713555|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713556|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713557|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713558|NCT00197236|E3|Reported Event|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
713559|NCT00197236|E2|Reported Event|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
713560|NCT00197236|E1|Reported Event|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
713561|NCT00197184|B3|Baseline|Total|Total of all reporting groups
713562|NCT00197184|B2|Baseline|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713563|NCT00197184|B1|Baseline|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713564|NCT00197184|P2|Participant Flow|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713565|NCT00197184|P1|Participant Flow|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713566|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713567|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713568|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713569|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713570|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713571|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713572|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713573|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713574|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713575|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713576|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713577|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713578|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713579|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713580|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713581|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713582|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713583|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713584|NCT00197184|E2|Reported Event|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
713585|NCT00197184|E1|Reported Event|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
713586|NCT00197119|B3|Baseline|Total|Total of all reporting groups
713587|NCT00197119|B2|Baseline|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
713588|NCT00197119|B1|Baseline|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
713589|NCT00197119|P2|Participant Flow|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
713590|NCT00197119|P1|Participant Flow|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
713591|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
713592|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
713593|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
713594|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
713595|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
713596|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
713597|NCT00197119|E2|Reported Event|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
713598|NCT00197119|E1|Reported Event|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
713599|NCT00197106|B3|Baseline|Total|Total of all reporting groups
713600|NCT00197106|B2|Baseline|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713601|NCT00197106|B1|Baseline|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713602|NCT00197106|P3|Participant Flow|FP 200 mcg|FP 200 mcg (delivered as two 100 mcg puffs) BID via DISKUS inhaler
713603|NCT00197106|P2|Participant Flow|Salmeterol/FP 50/100 mcg Plus Placebo|One puff Salmeterol/FP 50/100 mcg plus one puff placebo (matching one puff of FP in the 200 mcg group) BID via DISKUS inhaler
713604|NCT00197106|P1|Participant Flow|Fluticasone Propionate (FP) 100 mcg|Fluticasone propionate (FP) 100 mcg (micrograms) twice daily (BID) via DISKUS inhaler
713605|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713606|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713607|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713608|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713609|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713610|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713611|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713612|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713613|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713614|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713615|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713616|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713617|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713618|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713619|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713620|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713621|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713622|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713623|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713624|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713625|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713626|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713627|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713628|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713629|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713630|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713631|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713632|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713633|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713634|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713635|NCT00197106|E2|Reported Event|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
713636|NCT00197106|E1|Reported Event|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
713637|NCT00197028|B3|Baseline|Total|Total of all reporting groups
713638|NCT00197028|B2|Baseline|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713639|NCT00197028|B1|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713640|NCT00197028|P2|Participant Flow|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713641|NCT00197028|P1|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713642|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713643|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713644|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713645|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713646|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713647|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713648|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713649|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713650|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713651|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713652|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713653|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713654|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713655|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713704|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
714094|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
713656|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713657|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713658|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713659|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713660|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713661|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713662|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713663|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713664|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713665|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713666|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713667|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713668|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713669|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713670|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713671|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713672|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713705|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
714095|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
713673|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713674|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713675|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713676|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713677|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713678|NCT00197028|E2|Reported Event|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713679|NCT00197028|E1|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
713680|NCT00197015|B4|Baseline|Total|Total of all reporting groups
713681|NCT00197015|B3|Baseline|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713682|NCT00197015|B2|Baseline|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713683|NCT00197015|B1|Baseline|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713684|NCT00197015|P3|Participant Flow|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713685|NCT00197015|P2|Participant Flow|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713686|NCT00197015|P1|Participant Flow|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713687|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713688|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713689|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713690|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713691|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713692|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713693|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713694|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713695|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713696|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713697|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713698|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713699|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713700|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713701|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713702|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713703|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713706|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713707|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713708|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713709|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713710|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713711|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713712|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713713|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713714|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713715|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713716|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713717|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713718|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713719|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713720|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713721|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713722|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713723|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713724|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713725|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713726|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713727|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713728|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713729|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713730|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713731|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713732|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713733|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713734|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713735|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713736|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713737|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713738|NCT00197015|E3|Reported Event|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
713739|NCT00197015|E2|Reported Event|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
713740|NCT00197015|E1|Reported Event|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
713741|NCT00197002|B4|Baseline|Total|Total of all reporting groups
713742|NCT00197002|B3|Baseline|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713743|NCT00197002|B2|Baseline|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
714096|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
713744|NCT00197002|B1|Baseline|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713745|NCT00197002|P3|Participant Flow|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713746|NCT00197002|P2|Participant Flow|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713747|NCT00197002|P1|Participant Flow|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713748|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713749|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713750|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713751|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713752|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713753|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713754|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713755|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713756|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713757|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713758|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713759|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713760|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713761|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713762|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713763|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713764|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713765|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713766|NCT00197002|O1|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713767|NCT00197002|O1|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713855|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713768|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713769|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713770|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713771|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713772|NCT00197002|O2|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713773|NCT00197002|O1|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713774|NCT00197002|O2|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713775|NCT00197002|O1|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713776|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713777|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713778|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713779|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713780|NCT00197002|E3|Reported Event|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
713781|NCT00197002|E2|Reported Event|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
713782|NCT00197002|E1|Reported Event|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
713783|NCT00196976|B15|Baseline|Total|Total of all reporting groups
713784|NCT00196976|B14|Baseline|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713785|NCT00196976|B13|Baseline|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713786|NCT00196976|B12|Baseline|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713787|NCT00196976|B11|Baseline|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713788|NCT00196976|B10|Baseline|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713789|NCT00196976|B9|Baseline|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713790|NCT00196976|B8|Baseline|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713856|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713791|NCT00196976|B7|Baseline|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713792|NCT00196976|B6|Baseline|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713793|NCT00196976|B5|Baseline|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713794|NCT00196976|B4|Baseline|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713795|NCT00196976|B3|Baseline|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713796|NCT00196976|B2|Baseline|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713797|NCT00196976|B1|Baseline|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713798|NCT00196976|P14|Participant Flow|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713799|NCT00196976|P13|Participant Flow|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713800|NCT00196976|P12|Participant Flow|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713801|NCT00196976|P11|Participant Flow|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713802|NCT00196976|P10|Participant Flow|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713803|NCT00196976|P9|Participant Flow|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713804|NCT00196976|P8|Participant Flow|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713805|NCT00196976|P7|Participant Flow|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713806|NCT00196976|P6|Participant Flow|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713854|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713807|NCT00196976|P5|Participant Flow|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713808|NCT00196976|P4|Participant Flow|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713809|NCT00196976|P3|Participant Flow|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713810|NCT00196976|P2|Participant Flow|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713811|NCT00196976|P1|Participant Flow|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713812|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713813|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713814|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713815|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713816|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713817|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713818|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713819|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713820|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713821|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713822|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713823|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713824|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713825|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713826|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713827|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713828|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713829|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713830|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713831|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713832|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713833|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713834|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713835|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713836|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713837|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713838|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713839|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713840|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713841|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713842|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713843|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713844|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713845|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713846|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713847|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713848|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713849|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713850|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713851|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713852|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713853|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713857|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713858|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713859|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713860|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713861|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713862|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713863|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713864|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713865|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713866|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713867|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713868|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713869|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713870|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713871|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713872|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713873|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713874|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713875|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713876|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
714028|NCT00196937|O3|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
719146|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
713877|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713878|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713879|NCT00196976|O5|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713880|NCT00196976|O4|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713881|NCT00196976|O3|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713882|NCT00196976|O2|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713883|NCT00196976|O1|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713884|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713885|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713886|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713887|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713888|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713889|NCT00196976|O5|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713890|NCT00196976|O4|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713891|NCT00196976|O3|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713892|NCT00196976|O2|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713893|NCT00196976|O1|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713894|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713895|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713896|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713897|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713898|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713899|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713900|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713901|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713902|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713903|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713904|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713905|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713906|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713907|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714029|NCT00196937|O2|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule
713908|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713909|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713910|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713911|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713912|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713913|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713914|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713915|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713916|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713917|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713918|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713919|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713920|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713921|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713922|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713923|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
714030|NCT00196937|O1|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
713924|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713925|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713926|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713927|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713928|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713929|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713930|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713931|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713932|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713933|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713934|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713935|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713936|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713937|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714031|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
719147|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
713938|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713939|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713940|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713941|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713942|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713943|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713944|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713945|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713946|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713947|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713948|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713949|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713950|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713951|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713952|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713953|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
714032|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
713954|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713955|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713956|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713957|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713958|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713959|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713960|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713961|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713962|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713963|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713964|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713965|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713966|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713967|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714033|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
713968|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713969|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713970|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713971|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713972|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713973|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713974|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713975|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713976|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713977|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713978|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713979|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713980|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713981|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713982|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713983|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
714034|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
713984|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713985|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713986|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713987|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713988|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
713989|NCT00196976|E14|Reported Event|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
713990|NCT00196976|E13|Reported Event|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
713991|NCT00196976|E12|Reported Event|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713992|NCT00196976|E11|Reported Event|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
713993|NCT00196976|E10|Reported Event|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
713994|NCT00196976|E9|Reported Event|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713995|NCT00196976|E8|Reported Event|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713996|NCT00196976|E7|Reported Event|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713997|NCT00196976|E6|Reported Event|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
713998|NCT00196976|E5|Reported Event|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714035|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
714036|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
714097|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
713999|NCT00196976|E4|Reported Event|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714000|NCT00196976|E3|Reported Event|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714001|NCT00196976|E2|Reported Event|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714002|NCT00196976|E1|Reported Event|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
714003|NCT00196937|B4|Baseline|Total|Total of all reporting groups
714004|NCT00196937|B3|Baseline|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714005|NCT00196937|B2|Baseline|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714006|NCT00196937|B1|Baseline|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714007|NCT00196937|P3|Participant Flow|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714008|NCT00196937|P2|Participant Flow|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714009|NCT00196937|P1|Participant Flow|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714010|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714011|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714012|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714013|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714014|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714015|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714016|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714017|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714018|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714019|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714020|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714021|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714022|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714023|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714024|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714025|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714026|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714027|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714037|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714038|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714039|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714040|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
714041|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
714042|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
714043|NCT00196937|E3|Reported Event|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714044|NCT00196937|E2|Reported Event|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
714045|NCT00196937|E1|Reported Event|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
714046|NCT00196716|B1|Baseline|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
714047|NCT00196716|P1|Participant Flow|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
714048|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
714049|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
714050|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
714051|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
714052|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
714053|NCT00196716|E3|Reported Event|Total|
714054|NCT00196716|E2|Reported Event|0.3 mg/kg Fabrazyme|0.3 mg/kg Fabrazyme, Week 24 to Week 96.
714055|NCT00196716|E1|Reported Event|1.0 mg/kg Fabrazyme|1.0 mg/kg Fabrazyme, Week 0 to Week 24.
714056|NCT00196326|B1|Baseline|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
714057|NCT00196326|P1|Participant Flow|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
714058|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
714059|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
714060|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
714061|NCT00196326|E1|Reported Event|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
714062|NCT00196313|B3|Baseline|Total|Total of all reporting groups
714063|NCT00196313|B2|Baseline|Placebo|Placebo, 1 tablet daily
714064|NCT00196313|B1|Baseline|Seasonique|"Seasonique~, 1 tablet daily"
714065|NCT00196313|P2|Participant Flow|Placebo|Placebo, 1 tablet daily
714066|NCT00196313|P1|Participant Flow|Seasonique|"Seasonique~, 1 tablet daily"
714067|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
714068|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
714069|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
714070|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
714071|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
714072|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
714073|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
714074|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
714075|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
714076|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
714077|NCT00196313|E2|Reported Event|Placebo|Placebo, 1 tablet daily
714078|NCT00196313|E1|Reported Event|Seasonique|"Seasonique~, 1 tablet daily"
714079|NCT00196196|B1|Baseline|Codman VPV System|
714080|NCT00196196|P1|Participant Flow|Codman VPV System|
714081|NCT00196196|O1|Outcome|Codman VPV System|
714082|NCT00196196|O1|Outcome|Codman VPV System|
714083|NCT00196196|E1|Reported Event|Codman VPV System|
714084|NCT00196105|B4|Baseline|Total|Total of all reporting groups
714085|NCT00196105|B3|Baseline|10 mm Wallstent|10 mm Stainless Steel Wallstent
714086|NCT00196105|B2|Baseline|10 mm Zilver|10 mm Nitinol Zilver Stent
714087|NCT00196105|B1|Baseline|6 mm Zilver|6 mm Nitinol Zilver Stent
714088|NCT00196105|P3|Participant Flow|10 mm Wallstent|10 mm Stainless Steel Wallstent
714089|NCT00196105|P2|Participant Flow|10 mm Zilver|10 mm Nitinol Zilver Stent
714090|NCT00196105|P1|Participant Flow|6 mm Zilver|6 mm Nitinol Zilver Stent
714091|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
714092|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
714093|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
714100|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
714101|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
714102|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
714103|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
714104|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
714105|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
714106|NCT00196105|E3|Reported Event|10 mm Wallstent|10 mm Stainless Steel Wallstent
714107|NCT00196105|E2|Reported Event|10 mm Zilver|10 mm Nitinol Zilver Stent
714108|NCT00196105|E1|Reported Event|6 mm Zilver|6 mm Nitinol Zilver Stent
714109|NCT00195819|B1|Baseline|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714110|NCT00195819|P2|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
714111|NCT00195819|P1|Participant Flow|Placebo 40 mg Every Other Week (Eow), Subcutaneous (SC)|
714112|NCT00195819|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
714113|NCT00195819|O2|Outcome|Placebo|(Week 52 - placebo plus up to 40 weeks of adalimumab)
714114|NCT00195819|O1|Outcome|Adalimumab Exposure|Adalimumab 40 mg every other week (eow)
714115|NCT00195819|O2|Outcome|Placebo|(Week 52 - Placebo plus up to 40 weeks adalimumab)
714116|NCT00195819|O1|Outcome|Adalimumab|Adalimumab every other week (eow)
714117|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714118|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714119|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714120|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714121|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714122|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714123|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714124|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714125|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714126|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714127|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714128|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714129|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714130|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714131|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714132|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714133|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714134|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714135|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714136|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714137|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714138|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714139|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714140|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714141|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714142|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714143|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714144|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714145|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714146|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714147|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714148|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714149|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714150|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714151|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714152|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714153|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714154|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714155|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714156|NCT00195819|O1|Outcome|Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
714157|NCT00195819|O2|Outcome|Placebo|40 mg every other week, subcutaneous
714158|NCT00195819|O1|Outcome|Adalimumab|40 mg every other week, subcutaneous
714159|NCT00195819|E1|Reported Event|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
714160|NCT00195715|B1|Baseline|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714161|NCT00195715|P1|Participant Flow|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714162|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714163|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714164|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714165|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714166|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714167|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714168|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714169|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714170|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714171|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714172|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714173|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714174|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714175|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714176|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714177|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714178|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714179|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714180|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714181|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714182|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714183|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714184|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714185|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714186|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714187|NCT00195715|E1|Reported Event|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
714188|NCT00195702|B4|Baseline|Total|Total of all reporting groups
714189|NCT00195702|B3|Baseline|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714190|NCT00195702|B2|Baseline|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714191|NCT00195702|B1|Baseline|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714192|NCT00195702|P6|Participant Flow|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
714193|NCT00195702|P5|Participant Flow|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
714194|NCT00195702|P4|Participant Flow|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
714195|NCT00195702|P3|Participant Flow|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714196|NCT00195702|P2|Participant Flow|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714197|NCT00195702|P1|Participant Flow|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714198|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
714199|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
714200|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
714201|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
714202|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
714203|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
714204|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714999|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714205|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714206|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714207|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714208|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714209|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714210|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714211|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714212|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714213|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714214|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714215|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714216|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714217|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714218|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714219|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714220|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714221|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714222|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714223|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714224|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714225|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714226|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714227|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714228|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714229|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714230|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714231|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714232|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714233|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714234|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714235|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714236|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714237|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714238|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714239|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714240|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714241|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714242|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714243|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714244|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714245|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714246|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714247|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714248|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714249|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714250|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714251|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714252|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714253|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714254|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714255|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714256|NCT00195702|E4|Reported Event|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
714257|NCT00195702|E3|Reported Event|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714258|NCT00195702|E2|Reported Event|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
714259|NCT00195702|E1|Reported Event|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
714260|NCT00195676|B1|Baseline|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
714261|NCT00195676|P1|Participant Flow|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
714262|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Not Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had not relapsed (i.e., PGA not greater than or equal to 3) in Period W after adalimumab therapy was withdrawn.
714263|NCT00195676|O1|Outcome|Period R mITT Population Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had relapsed in Period W after adalimumab therapy was withdrawn.
714264|NCT00195676|O1|Outcome|Period W Modified Intent-to-treat Population|Participants from Period O who entered Period W with a PGA of 0 or 1 for the last 2 consecutive visits of Period O, at least 12 weeks apart, and received adalimumab 40 mg every other week for at least 12 weeks prior to entering Period W.
714265|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
714266|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
714267|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Population|Participants of the Period W Modified Intent-to-Treat(mITT) Population who received at least one retreatment dose of adalimumab 40 mg every other week in Period R. The Period W mITT Population had entered Period W from Period O with stable psoriasis control [i.e., had a PGA of 0 or 1 at the last 2 consecutive visits in Period O, at least 12 weeks apart, and were on adalimumab 40 mg every other week for the last 12 weeks of Period O).
714268|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
714269|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
714270|NCT00195676|E1|Reported Event|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
714271|NCT00195663|B4|Baseline|Total|Total of all reporting groups
714272|NCT00195663|B3|Baseline|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714273|NCT00195663|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
714274|NCT00195663|B1|Baseline|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714275|NCT00195663|P3|Participant Flow|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714276|NCT00195663|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
714277|NCT00195663|P1|Participant Flow|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714278|NCT00195663|O2|Outcome|Adalimumab: HAQ Decrease ≥ 0.5|Participants with a decrease of least 0.5 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
714279|NCT00195663|O1|Outcome|Adalimumab: HAQ Decrease ≥ 0.22|Participants with a decrease of least 0.22 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
714280|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
714281|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714282|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
714283|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714284|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714285|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
714286|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714287|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714288|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
714289|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
714290|NCT00195663|O2|Outcome|Adalimumab: DAS28 < 3.2|Participants with a DAS28 score less than 3.2, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
714291|NCT00195663|O1|Outcome|Adalimumab: DAS28 < 2.6|Participants with a DAS28 score less than 2.6, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
714292|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
714293|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
714417|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
714294|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
714295|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
714296|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
714297|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714298|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714299|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714300|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714301|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714302|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714303|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714304|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714305|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714306|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714307|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714308|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714309|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714310|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714311|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714312|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714313|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714314|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714315|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714316|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714317|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714318|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714319|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714320|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714321|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714322|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714323|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714324|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714325|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714326|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714327|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714328|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714329|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714330|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714331|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714332|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714333|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714334|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714335|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714336|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714337|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714338|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714339|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714340|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714341|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714342|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714343|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714344|NCT00195663|O1|Outcome|Methotrexate Weekly|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714345|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714346|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714347|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714348|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714349|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714350|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714351|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714352|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714353|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714354|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714355|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714356|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714357|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714358|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714359|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714360|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714361|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714362|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714363|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714364|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714365|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714366|NCT00195663|E4|Reported Event|Any Adalimumab|"Participants received either methotrexate, adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.~Adverse events reported include those that occurred at any time during adalimumab exposure (up to 10 years)."
714367|NCT00195663|E3|Reported Event|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714368|NCT00195663|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
714369|NCT00195663|E1|Reported Event|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
714370|NCT00195650|B1|Baseline|Adalimumab|Open-label adalimumab 40 mg
714371|NCT00195650|P1|Participant Flow|Adalimumab|Open-label adalimumab 40 mg
714372|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714373|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714374|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714375|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714376|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714377|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714378|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714379|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714380|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714381|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714382|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
714383|NCT00195650|E1|Reported Event|Adalimumab|Open-label adalimumab 40 mg
714385|NCT00195507|B2|Baseline|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
714386|NCT00195507|B1|Baseline|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
714387|NCT00195507|P2|Participant Flow|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
714388|NCT00195507|P1|Participant Flow|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
714389|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
714390|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
714391|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
714392|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
714393|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
714394|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
714395|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
714396|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
714397|NCT00195507|E2|Reported Event|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
714398|NCT00195507|E1|Reported Event|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
714399|NCT00195494|B3|Baseline|Total|Total of all reporting groups
714400|NCT00195494|B2|Baseline|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714401|NCT00195494|B1|Baseline|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714402|NCT00195494|P6|Participant Flow|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714403|NCT00195494|P5|Participant Flow|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714404|NCT00195494|P4|Participant Flow|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
714405|NCT00195494|P3|Participant Flow|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
714406|NCT00195494|P2|Participant Flow|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
714407|NCT00195494|P1|Participant Flow|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
714408|NCT00195494|O6|Outcome|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714409|NCT00195494|O5|Outcome|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714410|NCT00195494|O4|Outcome|Year 2 M / M|"Following a blinded transition from year one- MTX dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
714411|NCT00195494|O3|Outcome|Year 2 E+M / E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
714412|NCT00195494|O2|Outcome|Year 2 M / E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
714413|NCT00195494|O1|Outcome|Year 2 E+M / E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
714414|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
714415|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
714416|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
714418|NCT00195494|E6|Reported Event|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714419|NCT00195494|E5|Reported Event|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
714420|NCT00195494|E4|Reported Event|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
714421|NCT00195494|E3|Reported Event|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
714422|NCT00195494|E2|Reported Event|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
714423|NCT00195494|E1|Reported Event|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
714424|NCT00195442|B1|Baseline|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714425|NCT00195442|P1|Participant Flow|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714426|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714427|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714428|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714429|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714430|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714431|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714432|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714433|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714434|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714435|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714436|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714437|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714438|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714439|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714440|NCT00195442|E1|Reported Event|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
714441|NCT00195429|B3|Baseline|Total|Total of all reporting groups
714442|NCT00195429|B2|Baseline|Sirolimus + Prednisone|
714443|NCT00195429|B1|Baseline|Sirolimus + Tacrolimus|
714444|NCT00195429|P2|Participant Flow|Sirolimus + Prednisone|
714445|NCT00195429|P1|Participant Flow|Sirolimus + Tacrolimus|
714446|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
714447|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
714448|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
714449|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
714450|NCT00195429|E2|Reported Event|Sirolimus + Prednisone|
714451|NCT00195429|E1|Reported Event|Sirolimus + Tacrolimus|
714452|NCT00195403|B1|Baseline|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
714453|NCT00195403|P1|Participant Flow|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
714454|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
714455|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
715000|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714456|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
714457|NCT00195403|E1|Reported Event|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
714458|NCT00195351|B3|Baseline|Total|Total of all reporting groups
714459|NCT00195351|B2|Baseline|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
714460|NCT00195351|B1|Baseline|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
714461|NCT00195351|P2|Participant Flow|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
714462|NCT00195351|P1|Participant Flow|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
714463|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
714464|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
714465|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
714466|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
714467|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
714468|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
714469|NCT00195351|E2|Reported Event|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
714470|NCT00195351|E1|Reported Event|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
714471|NCT00195338|B1|Baseline|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714472|NCT00195338|P1|Participant Flow|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714473|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714474|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714475|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714476|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714477|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714478|NCT00195338|E1|Reported Event|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
714479|NCT00195273|B3|Baseline|Total|Total of all reporting groups
714480|NCT00195273|B2|Baseline|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714481|NCT00195273|B1|Baseline|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714482|NCT00195273|P2|Participant Flow|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714515|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714516|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
715001|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714483|NCT00195273|P1|Participant Flow|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714484|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714485|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714486|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714487|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714488|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714489|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714490|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714517|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714518|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
714491|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714492|NCT00195273|E2|Reported Event|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714493|NCT00195273|E1|Reported Event|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
714494|NCT00195260|B3|Baseline|Total|Total of all reporting groups
714495|NCT00195260|B2|Baseline|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714496|NCT00195260|B1|Baseline|Part 1|Participants received bosutinib capsule orally once daily continuously in 21-day cycles in dose escalation schemes of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in (500 mg) until disease progression, unacceptable toxicity, or consent withdrawal.
714497|NCT00195260|P11|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714498|NCT00195260|P10|Participant Flow|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714499|NCT00195260|P9|Participant Flow|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714500|NCT00195260|P8|Participant Flow|Maximum Tolerated Dose (MTD) lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714501|NCT00195260|P7|Participant Flow|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714502|NCT00195260|P6|Participant Flow|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714503|NCT00195260|P5|Participant Flow|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714504|NCT00195260|P4|Participant Flow|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714505|NCT00195260|P3|Participant Flow|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714506|NCT00195260|P2|Participant Flow|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714507|NCT00195260|P1|Participant Flow|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714508|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714509|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714510|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714511|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714512|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714513|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714514|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
715005|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714519|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714520|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714521|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714522|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714523|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714524|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714525|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
714526|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714527|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714528|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714529|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714530|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714531|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714532|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
714533|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714534|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714535|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714536|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714537|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714538|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714539|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
714540|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714541|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714542|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714543|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714544|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714545|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714546|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714547|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714548|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714549|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714550|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714551|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714552|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714553|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714554|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714555|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714556|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714557|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714558|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714559|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714560|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714561|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714562|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714563|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714564|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714565|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714566|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714567|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714568|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714569|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714570|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714571|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714572|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714573|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714574|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714575|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714576|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714577|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714578|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714579|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714580|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714581|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714582|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714583|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714584|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714585|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
715002|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714586|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714587|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714588|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714589|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714590|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714591|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714592|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714593|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714594|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714595|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714596|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714597|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714598|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714599|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714600|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714601|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714602|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714603|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714604|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714605|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714606|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714607|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714608|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714609|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714610|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714611|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714612|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714613|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714614|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714615|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714616|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714617|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714618|NCT00195260|O8|Outcome|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
719148|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
714619|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714620|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714621|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714622|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714623|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714624|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714625|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714626|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714627|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714628|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714629|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714630|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714631|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714632|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714633|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714634|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714635|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714636|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714637|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714638|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714639|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714640|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714641|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714642|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714643|NCT00195260|E9|Reported Event|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714644|NCT00195260|E8|Reported Event|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714645|NCT00195260|E7|Reported Event|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714646|NCT00195260|E6|Reported Event|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714647|NCT00195260|E5|Reported Event|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714648|NCT00195260|E4|Reported Event|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714649|NCT00195260|E3|Reported Event|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714650|NCT00195260|E2|Reported Event|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714651|NCT00195260|E1|Reported Event|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
714741|NCT00194610|E2|Reported Event|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
714742|NCT00194610|E1|Reported Event|Saline|Total 2 cc injected periurethrally
714652|NCT00195039|B1|Baseline|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714653|NCT00195039|P1|Participant Flow|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714654|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714655|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714656|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714657|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714658|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714659|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714660|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714743|NCT00194532|B3|Baseline|Total|Total of all reporting groups
714744|NCT00194532|B2|Baseline|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
714745|NCT00194532|B1|Baseline|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
714661|NCT00195039|O1|Outcome|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714662|NCT00195039|E1|Reported Event|All Patients|"Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (naked) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.~177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated (“naked”) J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min."
714663|NCT00195013|B3|Baseline|Total|Total of all reporting groups
714664|NCT00195013|B2|Baseline|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
714665|NCT00195013|B1|Baseline|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
714666|NCT00195013|P2|Participant Flow|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
714667|NCT00195013|P1|Participant Flow|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
714668|NCT00195013|O2|Outcome|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
714669|NCT00195013|O1|Outcome|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
714670|NCT00195013|E2|Reported Event|Placebo|"10 grams three times a day (orally) for four days and then stop~Placebo: 10 grams three times a day (orally) for four days and then stop"
714671|NCT00195013|E1|Reported Event|Glutamine|"10 grams three times a day (orally) for four days and then stop~glutamine: 10 grams three times a day (orally) for four days and then stop"
714672|NCT00194896|B5|Baseline|Total|Total of all reporting groups
714673|NCT00194896|B4|Baseline|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714674|NCT00194896|B3|Baseline|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
714675|NCT00194896|B2|Baseline|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714676|NCT00194896|B1|Baseline|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
714677|NCT00194896|P4|Participant Flow|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714678|NCT00194896|P3|Participant Flow|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
714679|NCT00194896|P2|Participant Flow|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714746|NCT00194532|P2|Participant Flow|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
714747|NCT00194532|P1|Participant Flow|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
714748|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
714680|NCT00194896|P1|Participant Flow|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
714681|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714682|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
714683|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714684|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
714685|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714686|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
714687|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714688|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
714689|NCT00194896|E4|Reported Event|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714690|NCT00194896|E3|Reported Event|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
714691|NCT00194896|E2|Reported Event|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
714692|NCT00194896|E1|Reported Event|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
714693|NCT00194792|B1|Baseline|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714694|NCT00194792|P1|Participant Flow|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714695|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714696|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714697|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714698|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714699|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714700|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714701|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714702|NCT00194792|E1|Reported Event|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
714703|NCT00194779|B1|Baseline|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714704|NCT00194779|P1|Participant Flow|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714705|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714706|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714707|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714708|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714749|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
714750|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
714751|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
714752|NCT00194532|E2|Reported Event|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
719149|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
714709|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714710|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714711|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714712|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714713|NCT00194779|O1|Outcome|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714714|NCT00194779|E1|Reported Event|Treatment (Neoadjuvant Therapy, Adjuvant Therapy)|"See Detailed Description.~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~paclitaxel: Given IV~filgrastim: Given SC~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~needle biopsy: Correlative studies~therapeutic conventional surgery: Undergo definitive breast surgery~immunohistochemistry staining method: Correlative studies~trastuzumab: Given IV~tamoxifen citrate: Given PO~letrozole: Given PO~laboratory biomarker analysis: Correlative studies"
714715|NCT00194675|B3|Baseline|Total|Total of all reporting groups
714716|NCT00194675|B2|Baseline|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
714717|NCT00194675|B1|Baseline|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
714718|NCT00194675|P2|Participant Flow|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
714719|NCT00194675|P1|Participant Flow|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
714720|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
714721|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
714722|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
714723|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
714724|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
714725|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
714726|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
714727|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
714728|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
714729|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
714730|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
714731|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
714732|NCT00194675|E2|Reported Event|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
714733|NCT00194675|E1|Reported Event|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
714734|NCT00194610|B3|Baseline|Total|Total of all reporting groups
714735|NCT00194610|B2|Baseline|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
714736|NCT00194610|B1|Baseline|Saline|Total 2 cc injected periurethrally
714737|NCT00194610|P2|Participant Flow|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
714738|NCT00194610|P1|Participant Flow|Saline|Total 2 cc injected periurethrally
714739|NCT00194610|O2|Outcome|Experimental Intervention: Botox|Botulinum toxin 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible, but not mandatory, injections of 25 IU in each of 2 trigger points.
714740|NCT00194610|O1|Outcome|Placebo : Saline|Saline 2 cc total injected periurethrally
714753|NCT00194532|E1|Reported Event|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
714757|NCT00194129|P2|Participant Flow|Lithium Plus Placebo|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to placebo arm, placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
714758|NCT00194129|P1|Participant Flow|Lithium Plus Divalproex|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to divalproex arm, divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.
714759|NCT00194129|O1|Outcome|Completers|This only includes subjects who had cocaine use disorder at study entry.
714760|NCT00194129|O1|Outcome|Completers|This only includes subjects who had a cannabis use disorder at study entry.
714761|NCT00194129|O1|Outcome|Completers|This analysis only includes subjects who had an alcohol use disorder at study entry.
714762|NCT00194129|O2|Outcome|Lithium Plus Placebo|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to placebo arm, placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
714763|NCT00194129|O1|Outcome|Lithium Plus Divalproex|Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to divalproex arm, divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.
714764|NCT00194129|O2|Outcome|Lithium Plus Placebo|"Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued.~Lithium: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3–6 weeks to minimum blood levels of 0.8 meq/L.~Placebo: Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily."
714765|NCT00194129|O1|Outcome|Lithium Plus Divalproex|"Patients assigned to the combination group were continued on lithium and blinded divalproex.~Lithium: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3–6 weeks to minimum blood levels of 0.8 meq/L.~Divalproex: Divalproex was then initiated at 250 mg twice daily and increased over 3–6 weeks to minimum blood levels of 50 ug/ml."
714766|NCT00194129|O2|Outcome|Lithium Plus Placebo|
714767|NCT00194129|O1|Outcome|Lithium Plus Divalproex|
714768|NCT00194129|E2|Reported Event|Lithium Plus Placebo|
714769|NCT00194129|E1|Reported Event|Lithium Plus Divalproex|
714770|NCT00194077|B3|Baseline|Total|Total of all reporting groups
714771|NCT00194077|B2|Baseline|Placebo|Placebo (Children with Symptoms of Mania Study)
714772|NCT00194077|B1|Baseline|Aripiprazole|Abilify (Children with Symptoms of Mania Study)
714773|NCT00194077|P2|Participant Flow|Placebo|Randomized assignment to placebo
714774|NCT00194077|P1|Participant Flow|Aripiprazole|Random assignment with titrated dosing
714775|NCT00194077|O2|Outcome|Placebo|Placebo dosing to mirror active treatment
714776|NCT00194077|O1|Outcome|Aripiprazole|Aripiprazole dosing dependent upon response
714777|NCT00194077|E2|Reported Event|Placebo|Placebo (Children With Symptoms of Mania Study)
714778|NCT00194077|E1|Reported Event|Aripiprazole|Abilify (Children With Symptoms of Mania Study)
714779|NCT00194025|B1|Baseline|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714780|NCT00194025|P1|Participant Flow|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714781|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714782|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714783|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714784|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714808|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
715003|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714785|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714786|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714787|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714788|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714789|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714790|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714791|NCT00194025|E1|Reported Event|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
714792|NCT00194012|B3|Baseline|Total|Total of all reporting groups
714793|NCT00194012|B2|Baseline|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714794|NCT00194012|B1|Baseline|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714795|NCT00194012|P2|Participant Flow|Placebo|placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714796|NCT00194012|P1|Participant Flow|Aripiprazole|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714797|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714798|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714799|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714800|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714801|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714802|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714803|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714804|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714805|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714806|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714807|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714809|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714810|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714811|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714812|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714813|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714814|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714815|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714816|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714817|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714818|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714819|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714820|NCT00194012|O1|Outcome|Aripiprazole Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714821|NCT00194012|O2|Outcome|Open-Label Extension (Placebo)|"Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714822|NCT00194012|O1|Outcome|Open-Label Extension (Abilify)|"Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.~All participants in the open-label extension were taking Abilify (aripiprazole)."
714823|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714824|NCT00194012|O1|Outcome|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714825|NCT00194012|O2|Outcome|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714826|NCT00194012|O1|Outcome|Abilify Randomized Phase|Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714827|NCT00194012|E4|Reported Event|Open Label Extension (Placebo)|Previously randomized to placebo group.
714828|NCT00194012|E3|Reported Event|Open Label Extension (Abilify)|Previously randomized to Abilify group.
714829|NCT00194012|E2|Reported Event|Placebo Randomized Phase|Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
714830|NCT00194012|E1|Reported Event|Abilify Randomized Phase|Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
714831|NCT00193609|B1|Baseline|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
714832|NCT00193609|P1|Participant Flow|Oxaliplatin/Capecitabine|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
714833|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
714834|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
714835|NCT00193609|E1|Reported Event|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
714836|NCT00193596|B3|Baseline|Total|Total of all reporting groups
714837|NCT00193596|B2|Baseline|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
714838|NCT00193596|B1|Baseline|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
714839|NCT00193596|P2|Participant Flow|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
714988|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
719150|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
714840|NCT00193596|P1|Participant Flow|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
714841|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
714842|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
714843|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
714844|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
714845|NCT00193596|E2|Reported Event|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
714846|NCT00193596|E1|Reported Event|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
714847|NCT00193492|B3|Baseline|Total|Total of all reporting groups
714848|NCT00193492|B2|Baseline|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
714849|NCT00193492|B1|Baseline|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
714850|NCT00193492|P2|Participant Flow|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
714851|NCT00193492|P1|Participant Flow|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
714852|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
714853|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
714854|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
714855|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
714856|NCT00193492|E2|Reported Event|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
714857|NCT00193492|E1|Reported Event|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
714858|NCT00193479|B1|Baseline|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
714859|NCT00193479|P1|Participant Flow|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
714989|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714860|NCT00193479|O1|Outcome|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
714861|NCT00193479|E1|Reported Event|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
714862|NCT00193453|B1|Baseline|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
714863|NCT00193453|P1|Participant Flow|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
714864|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
714865|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
714866|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
714867|NCT00193453|E1|Reported Event|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
714868|NCT00193427|B1|Baseline|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
714869|NCT00193427|P1|Participant Flow|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
714870|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
714871|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
714872|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered.
714873|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
714874|NCT00193427|E1|Reported Event|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
714875|NCT00193414|B1|Baseline|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
714876|NCT00193414|P1|Participant Flow|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
714877|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
714878|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
714879|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
714990|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714991|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714880|NCT00193414|E1|Reported Event|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
714881|NCT00193375|B1|Baseline|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
714882|NCT00193375|P1|Participant Flow|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
714883|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
714884|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
714885|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
714886|NCT00193375|E1|Reported Event|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
714887|NCT00193258|B1|Baseline|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
714888|NCT00193258|P1|Participant Flow|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
714889|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
714890|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
714891|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
714892|NCT00193258|E1|Reported Event|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
714893|NCT00193219|B1|Baseline|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
714894|NCT00193219|P1|Participant Flow|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
714895|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
714896|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
714992|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714993|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
715004|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714897|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
714898|NCT00193219|E1|Reported Event|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
714899|NCT00193206|B1|Baseline|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
714900|NCT00193206|P1|Participant Flow|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
714901|NCT00193206|O1|Outcome|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
714902|NCT00193206|E1|Reported Event|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
714903|NCT00193180|B1|Baseline|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
714904|NCT00193180|P1|Participant Flow|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
714905|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
714906|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
714907|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
714908|NCT00193180|E1|Reported Event|Docetaxel+Imatinib|Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose.
714909|NCT00193128|B3|Baseline|Total|Total of all reporting groups
714910|NCT00193128|B2|Baseline|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714911|NCT00193128|B1|Baseline|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714912|NCT00193128|P2|Participant Flow|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714913|NCT00193128|P1|Participant Flow|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714994|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714995|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
719151|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
714914|NCT00193128|O2|Outcome|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714915|NCT00193128|O1|Outcome|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714916|NCT00193128|E2|Reported Event|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714917|NCT00193128|E1|Reported Event|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
714918|NCT00193063|B1|Baseline|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
714919|NCT00193063|P1|Participant Flow|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
714920|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
714921|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
714922|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
714923|NCT00193063|E1|Reported Event|Intervention|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
714924|NCT00193050|B1|Baseline|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
714925|NCT00193050|P1|Participant Flow|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
714926|NCT00193050|O1|Outcome|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
714927|NCT00193050|E1|Reported Event|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
714928|NCT00193037|B3|Baseline|Total|Total of all reporting groups
714996|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714929|NCT00193037|B2|Baseline|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
714930|NCT00193037|B1|Baseline|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
714931|NCT00193037|P2|Participant Flow|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria."
714932|NCT00193037|P1|Participant Flow|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria."
714933|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
714934|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
714935|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
714936|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
714937|NCT00193037|E2|Reported Event|Arm B - Docetaxel Then Liposomal Doxorubicin|Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
714938|NCT00193037|E1|Reported Event|Arm A - Liposomal Doxorubicin Then Docetaxel|Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria.
714939|NCT00192647|B3|Baseline|Total|Total of all reporting groups
714940|NCT00192647|B2|Baseline|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714941|NCT00192647|B1|Baseline|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714942|NCT00192647|P2|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714943|NCT00192647|P1|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714944|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714945|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714946|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714997|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714998|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714947|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714948|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714949|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714950|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714951|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714952|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714953|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714954|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714955|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714956|NCT00192647|E2|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
714957|NCT00192647|E1|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
714958|NCT00192296|B5|Baseline|Total|Total of all reporting groups
714959|NCT00192296|B4|Baseline|MEDI-528 9 mg|
714960|NCT00192296|B3|Baseline|MEDI-528 3 mg|
714961|NCT00192296|B2|Baseline|MEDI-528 1 mg|
714962|NCT00192296|B1|Baseline|MEDI-528 0.3 mg|
714963|NCT00192296|P4|Participant Flow|MEDI-528 9 mg|
714964|NCT00192296|P3|Participant Flow|MEDI-528 3 mg|
714965|NCT00192296|P2|Participant Flow|MEDI-528 1 mg|
714966|NCT00192296|P1|Participant Flow|MEDI-528 0.3 mg|
714967|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714968|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714969|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714970|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714971|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714972|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714973|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714974|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714975|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714976|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714977|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714978|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714979|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714980|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714981|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714982|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714983|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
714984|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
714985|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
714986|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
714987|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
715006|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
715007|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
715008|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
715009|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
715010|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
715011|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
715012|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
715013|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
715014|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
715015|NCT00192296|E4|Reported Event|MEDI-528 9 mg|
715016|NCT00192296|E3|Reported Event|MEDI-528 3 mg|
715017|NCT00192296|E2|Reported Event|MEDI-528 1 mg|
715018|NCT00192296|E1|Reported Event|MEDI-528 0.3 mg|
715019|NCT00192075|B3|Baseline|Total|Total of all reporting groups
715020|NCT00192075|B2|Baseline|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715021|NCT00192075|B1|Baseline|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715022|NCT00192075|P2|Participant Flow|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715023|NCT00192075|P1|Participant Flow|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715024|NCT00192075|O1|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715025|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715026|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715027|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
715028|NCT00192075|O1|Outcome|A+FFG - Avastin Subgrouup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
715029|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
715030|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
715031|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
715032|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
715033|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
715034|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
715035|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
715036|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
715037|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715038|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715039|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715040|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715041|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715042|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715043|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715044|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715045|NCT00192075|E2|Reported Event|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
715046|NCT00192075|E1|Reported Event|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
715047|NCT00192036|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
715048|NCT00192036|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
715049|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
719152|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
715050|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
715051|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
715052|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
715053|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
715054|NCT00192036|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
715055|NCT00192023|B3|Baseline|Total|Total of all reporting groups
715056|NCT00192023|B2|Baseline|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715057|NCT00192023|B1|Baseline|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715058|NCT00192023|P2|Participant Flow|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715059|NCT00192023|P1|Participant Flow|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715060|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715061|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715062|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715063|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715064|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715065|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715066|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715067|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715068|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715069|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715070|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715071|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715072|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715073|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715074|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715075|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715076|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715108|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
715077|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715078|NCT00192023|E2|Reported Event|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715079|NCT00192023|E1|Reported Event|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
715080|NCT00191984|B1|Baseline|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715081|NCT00191984|P1|Participant Flow|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715082|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715083|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715084|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715085|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715086|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715087|NCT00191984|E1|Reported Event|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
715088|NCT00191945|B3|Baseline|Total|Total of all reporting groups
715089|NCT00191945|B2|Baseline|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715090|NCT00191945|B1|Baseline|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715091|NCT00191945|P2|Participant Flow|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715092|NCT00191945|P1|Participant Flow|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715093|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715094|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715095|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715096|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715097|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715098|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715099|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715100|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715101|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
715102|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715103|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715104|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715105|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715106|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715107|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715109|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715110|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715111|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715112|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715113|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715114|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715115|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715116|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715117|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715118|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715119|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715120|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715121|NCT00191945|E2|Reported Event|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715122|NCT00191945|E1|Reported Event|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
715123|NCT00191906|B5|Baseline|Total|Total of all reporting groups
715124|NCT00191906|B4|Baseline|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
715125|NCT00191906|B3|Baseline|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
715126|NCT00191906|B2|Baseline|Placebo First, Then Atomoxetine|Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
715127|NCT00191906|B1|Baseline|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
715128|NCT00191906|P4|Participant Flow|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
715129|NCT00191906|P3|Participant Flow|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
715130|NCT00191906|P2|Participant Flow|Placebo First, Then Atomoxetine|Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.
715131|NCT00191906|P1|Participant Flow|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
715132|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
715133|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
715134|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
715135|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
715136|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
715137|NCT00191906|O1|Outcome|ADHD-C+ RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
715138|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
715139|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
715140|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
715141|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
715142|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715143|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715144|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715145|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715146|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715147|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715148|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715149|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715150|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715151|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715152|NCT00191906|O2|Outcome|Placebo|
715153|NCT00191906|O1|Outcome|Atomoxetine|
715154|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715155|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715156|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715157|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715158|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715159|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715160|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
715161|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
715162|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
715163|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
715164|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
715165|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
715166|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
715167|NCT00191906|E3|Reported Event|Open Label Atomoxetine|Patients in the Open Label extension receiving Atomoxetine
715168|NCT00191906|E2|Reported Event|As Randomized Atomoxetine (Crossover)|Patients in either Crossover Period receiving Atomoxetine
715169|NCT00191906|E1|Reported Event|As Randomized Placebo (Crossover)|Patients in either Crossover Period receiving Placebo
715170|NCT00191854|B4|Baseline|Total|Total of all reporting groups
715171|NCT00191854|B3|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715172|NCT00191854|B2|Baseline|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715173|NCT00191854|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715174|NCT00191854|P3|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715175|NCT00191854|P2|Participant Flow|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715176|NCT00191854|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715177|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715178|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715179|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715180|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715181|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715182|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715183|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715184|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715185|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715186|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715187|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715188|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715189|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715190|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715191|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715192|NCT00191854|E3|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
715193|NCT00191854|E2|Reported Event|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
715194|NCT00191854|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
715195|NCT00191815|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715196|NCT00191815|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715197|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715198|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715199|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715200|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715201|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715202|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715203|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715204|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715205|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715206|NCT00191815|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
715207|NCT00191789|B1|Baseline|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715208|NCT00191789|P1|Participant Flow|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715209|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715210|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715211|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715212|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715235|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715449|NCT00191165|E2|Reported Event|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
715213|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715214|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715215|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715216|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715217|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715218|NCT00191789|E1|Reported Event|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
715219|NCT00191724|B6|Baseline|Total|Total of all reporting groups
715220|NCT00191724|B5|Baseline|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715221|NCT00191724|B4|Baseline|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715222|NCT00191724|B3|Baseline|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715223|NCT00191724|B2|Baseline|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715224|NCT00191724|B1|Baseline|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715225|NCT00191724|P5|Participant Flow|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715226|NCT00191724|P4|Participant Flow|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715227|NCT00191724|P3|Participant Flow|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715228|NCT00191724|P2|Participant Flow|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715229|NCT00191724|P1|Participant Flow|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715230|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715231|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715232|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715233|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715234|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715294|NCT00191477|E1|Reported Event|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
715236|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715237|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715238|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715239|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715240|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715241|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715242|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715243|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715244|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715245|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715246|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715247|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715248|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715249|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715250|NCT00191724|E5|Reported Event|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715251|NCT00191724|E4|Reported Event|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715252|NCT00191724|E3|Reported Event|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715253|NCT00191724|E2|Reported Event|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715254|NCT00191724|E1|Reported Event|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
715255|NCT00191646|B3|Baseline|Total|Total of all reporting groups
715256|NCT00191646|B2|Baseline|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
715257|NCT00191646|B1|Baseline|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
715258|NCT00191646|P2|Participant Flow|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
715259|NCT00191646|P1|Participant Flow|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
715295|NCT00191451|B4|Baseline|Total|Total of all reporting groups
715450|NCT00191165|E1|Reported Event|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
715260|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
715261|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
715262|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
715263|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
715264|NCT00191646|O4|Outcome|Paclitaxel (Crossover)|Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
715265|NCT00191646|O3|Outcome|Gemcitabine (Crossover)|Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
715266|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin (Induction)|Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21-day cycles
715267|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin (Induction)|Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1, Day 8, Carboplatin AUC 5 Day 1, six 21-day cycles
715268|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
715269|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
715270|NCT00191646|E6|Reported Event|Crossover (Gemcitabine to Paclitaxel)|Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
715271|NCT00191646|E5|Reported Event|Crossover (Paclitaxel to Gemcitabine)|Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
715272|NCT00191646|E4|Reported Event|Consolidation (Paclitaxel to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
715273|NCT00191646|E3|Reported Event|Consolidation (Gemcitabine to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
715274|NCT00191646|E2|Reported Event|Paclitaxel/Carboplatin Induction|Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
715275|NCT00191646|E1|Reported Event|Gemcitabine/Carboplatin Induction|Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
715276|NCT00191477|B3|Baseline|Total|Total of all reporting groups
715277|NCT00191477|B2|Baseline|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715278|NCT00191477|B1|Baseline|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715279|NCT00191477|P2|Participant Flow|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715280|NCT00191477|P1|Participant Flow|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715281|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715282|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715283|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715284|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715285|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715286|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715287|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715288|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715289|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715290|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715291|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715292|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
715293|NCT00191477|E2|Reported Event|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
715451|NCT00191152|B3|Baseline|Total|Total of all reporting groups
715296|NCT00191451|B3|Baseline|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715297|NCT00191451|B2|Baseline|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715298|NCT00191451|B1|Baseline|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715299|NCT00191451|P3|Participant Flow|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715300|NCT00191451|P2|Participant Flow|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715301|NCT00191451|P1|Participant Flow|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715302|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715303|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715304|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715305|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715306|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715307|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715308|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715309|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715310|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715444|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
715445|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
715311|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715312|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715313|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715314|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715315|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715316|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715317|NCT00191451|E3|Reported Event|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715318|NCT00191451|E2|Reported Event|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
715319|NCT00191451|E1|Reported Event|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
715320|NCT00191386|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
715321|NCT00191386|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
715322|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
715323|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
715324|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
715325|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
715326|NCT00191386|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
715327|NCT00191334|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715328|NCT00191334|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715329|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715330|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715331|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715332|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715333|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715334|NCT00191334|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
715335|NCT00191308|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715336|NCT00191308|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715337|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715338|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715339|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715340|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715341|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715342|NCT00191308|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
715343|NCT00191282|B3|Baseline|Total|Total of all reporting groups
715344|NCT00191282|B2|Baseline|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715345|NCT00191282|B1|Baseline|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715346|NCT00191282|P2|Participant Flow|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715347|NCT00191282|P1|Participant Flow|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715348|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715349|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715350|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715351|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715352|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715353|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715354|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715355|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715356|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715357|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715358|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715359|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715360|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715361|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715362|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715363|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715364|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715365|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715366|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715367|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715368|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715446|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
715369|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715370|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715371|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715372|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715373|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715374|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715375|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715376|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715377|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715378|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715379|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715380|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715381|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715382|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715383|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715384|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715447|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
715385|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715386|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715387|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715388|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715389|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715390|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715391|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715392|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715393|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715394|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715395|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715396|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715397|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715398|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715399|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715400|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715448|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
715401|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715402|NCT00191282|E2|Reported Event|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
715403|NCT00191282|E1|Reported Event|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
715404|NCT00191269|B3|Baseline|Total|Total of all reporting groups
715405|NCT00191269|B2|Baseline|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715406|NCT00191269|B1|Baseline|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715407|NCT00191269|P2|Participant Flow|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715408|NCT00191269|P1|Participant Flow|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715409|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
715410|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
715411|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715412|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715413|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715414|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715415|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715416|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715417|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715418|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715419|NCT00191269|E2|Reported Event|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715420|NCT00191269|E1|Reported Event|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
715421|NCT00191191|B3|Baseline|Total|Total of all reporting groups
715422|NCT00191191|B2|Baseline|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715423|NCT00191191|B1|Baseline|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715424|NCT00191191|P2|Participant Flow|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715425|NCT00191191|P1|Participant Flow|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715426|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715427|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715428|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715429|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715430|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715431|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715432|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715433|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715434|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715435|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715436|NCT00191191|E2|Reported Event|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
715437|NCT00191191|E1|Reported Event|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
715438|NCT00191165|B3|Baseline|Total|Total of all reporting groups
715439|NCT00191165|B2|Baseline|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
715440|NCT00191165|B1|Baseline|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
715441|NCT00191165|P2|Participant Flow|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
715442|NCT00191165|P1|Participant Flow|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
715443|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
715670|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715452|NCT00191152|B2|Baseline|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
715453|NCT00191152|B1|Baseline|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued."
715454|NCT00191152|P2|Participant Flow|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
715455|NCT00191152|P1|Participant Flow|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline."
715456|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
715457|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
715458|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
715459|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
715460|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days
715461|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days
715462|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
715463|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
715464|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
715465|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
715466|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
715467|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
715468|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
715469|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
715470|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
715471|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
715472|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
715473|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
715474|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.
715475|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|"gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.~Treatment continues until progression of disease at which time crossover treatment begins."
715476|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
715477|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
715478|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
715479|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
715480|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
715481|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
715482|NCT00191152|E2|Reported Event|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
715483|NCT00191152|E1|Reported Event|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued."
715484|NCT00191139|B3|Baseline|Total|Total of all reporting groups
715485|NCT00191139|B2|Baseline|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715486|NCT00191139|B1|Baseline|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715487|NCT00191139|P2|Participant Flow|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715488|NCT00191139|P1|Participant Flow|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715489|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715490|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715491|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715492|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715493|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715494|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715495|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715496|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715497|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715498|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715499|NCT00191139|E2|Reported Event|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
715500|NCT00191139|E1|Reported Event|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
715501|NCT00191113|B3|Baseline|Total|Total of all reporting groups
715502|NCT00191113|B2|Baseline|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
715671|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715503|NCT00191113|B1|Baseline|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
715504|NCT00191113|P2|Participant Flow|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
715505|NCT00191113|P1|Participant Flow|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
715506|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715507|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715508|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715509|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715510|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
715511|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
715512|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715513|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715514|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715515|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715516|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
715517|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715518|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715519|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715520|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
715521|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715522|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715523|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715524|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in As-Randomized Humatrope group who received Humatrope treatment
715525|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
715526|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715527|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715528|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715529|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715530|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715531|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715532|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715533|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715534|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
715535|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715536|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
715537|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715538|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
715539|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
715540|NCT00191113|O2|Outcome|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
715541|NCT00191113|O1|Outcome|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
715542|NCT00191113|E2|Reported Event|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
715543|NCT00191113|E1|Reported Event|Treated-As-Randomized Control|Patients in the As-Randomized Control group who at each observed time point remained untreated with growth hormone.
715544|NCT00191100|B3|Baseline|Total|Total of all reporting groups
715545|NCT00191100|B2|Baseline|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715546|NCT00191100|B1|Baseline|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
719153|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
715547|NCT00191100|P2|Participant Flow|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715548|NCT00191100|P1|Participant Flow|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715549|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715550|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715551|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715552|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715553|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715554|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715555|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715556|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715557|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715558|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715559|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715560|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715561|NCT00191100|E2|Reported Event|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
715562|NCT00191100|E1|Reported Event|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
715563|NCT00190983|B1|Baseline|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
715564|NCT00190983|P1|Participant Flow|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
715565|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
715566|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
715567|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
715568|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
715569|NCT00190983|E1|Reported Event|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
715570|NCT00190775|B3|Baseline|Total|Total of all reporting groups
715571|NCT00190775|B2|Baseline|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715672|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715572|NCT00190775|B1|Baseline|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715573|NCT00190775|P2|Participant Flow|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715574|NCT00190775|P1|Participant Flow|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715575|NCT00190775|O3|Outcome|Atomoxetine|Atomoxetine for 24 weeks
715576|NCT00190775|O2|Outcome|Placebo/Atomoxetine Group 2|Placebo for 24 weeks followed by atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
715577|NCT00190775|O1|Outcome|Placebo/Atomoxetine Group 1|Placebo for 24 Weeks followed by atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
715578|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
715579|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
715580|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
715581|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
715582|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
715583|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 4 days
715584|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715585|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715586|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715587|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715588|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715589|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715590|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715591|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715592|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715593|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715594|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715595|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715596|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715597|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715598|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715599|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715600|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715601|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715602|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715603|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715604|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715605|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715606|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715607|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715608|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715609|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715610|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715611|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715612|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715613|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715614|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715615|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715616|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715617|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715618|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715619|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715620|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715621|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715622|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715623|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715624|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715625|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715626|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715627|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715628|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715629|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715630|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715631|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715632|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715633|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715634|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715635|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715636|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715637|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715638|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715639|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715640|NCT00190775|E2|Reported Event|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
715641|NCT00190775|E1|Reported Event|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
715642|NCT00190749|B3|Baseline|Total|Total of all reporting groups
715643|NCT00190749|B2|Baseline|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715644|NCT00190749|B1|Baseline|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715645|NCT00190749|P2|Participant Flow|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715646|NCT00190749|P1|Participant Flow|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715647|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715648|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715649|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715650|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715651|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715652|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715653|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715654|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715655|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715656|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715657|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715658|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715659|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715660|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715661|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715662|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715663|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715664|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715665|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715666|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715667|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715668|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715669|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715749|NCT00189540|B3|Baseline|Total|Total of all reporting groups
715673|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715674|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715675|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715676|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715677|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715678|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715679|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715680|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715681|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715682|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715683|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715684|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715685|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715686|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715687|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715688|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715689|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715690|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715691|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715692|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715693|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715694|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715695|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715696|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715697|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715698|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715699|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715700|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715701|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715702|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715703|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715704|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715705|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715706|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715707|NCT00190749|E2|Reported Event|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
715708|NCT00190749|E1|Reported Event|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
715709|NCT00190684|B1|Baseline|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715710|NCT00190684|P1|Participant Flow|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715711|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715712|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715713|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715714|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715715|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715716|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715717|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715718|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715719|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715720|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715721|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715722|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715723|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715724|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715725|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715726|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715727|NCT00190684|E1|Reported Event|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
715728|NCT00190671|B3|Baseline|Total|Total of all reporting groups
715729|NCT00190671|B2|Baseline|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715730|NCT00190671|B1|Baseline|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715731|NCT00190671|P2|Participant Flow|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715732|NCT00190671|P1|Participant Flow|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715733|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715734|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715735|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715736|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715737|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715738|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715739|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715740|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715741|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715742|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715743|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715744|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715745|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715746|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715747|NCT00190671|E2|Reported Event|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715748|NCT00190671|E1|Reported Event|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
715750|NCT00189540|B2|Baseline|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715751|NCT00189540|B1|Baseline|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715752|NCT00189540|P2|Participant Flow|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715753|NCT00189540|P1|Participant Flow|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715754|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715755|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715756|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715757|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715758|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715759|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715760|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715761|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715762|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715763|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715764|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715765|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715766|NCT00189540|E2|Reported Event|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
715767|NCT00189540|E1|Reported Event|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
715768|NCT00189488|B3|Baseline|Total|Total of all reporting groups
715769|NCT00189488|B2|Baseline|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715770|NCT00189488|B1|Baseline|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715771|NCT00189488|P2|Participant Flow|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively
715772|NCT00189488|P1|Participant Flow|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.
715773|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715774|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715775|NCT00189488|O2|Outcome|Palifermin|PaPalifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715776|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715777|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715778|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715779|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715780|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715781|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715782|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715783|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715826|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
719154|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
715784|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715785|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715786|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715787|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715788|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715789|NCT00189488|E2|Reported Event|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
715790|NCT00189488|E1|Reported Event|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
715791|NCT00189475|B3|Baseline|Total|Total of all reporting groups
715792|NCT00189475|B2|Baseline|Placebo|Treated for 4 months with placebo
715793|NCT00189475|B1|Baseline|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
715794|NCT00189475|P2|Participant Flow|Placebo|Treated for 4 months with placebo
715795|NCT00189475|P1|Participant Flow|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
715796|NCT00189475|O2|Outcome|Placebo|Treated for 6 days with placebo
715797|NCT00189475|O1|Outcome|Montelukast|Montelukast 10mg per day for 6 days
715798|NCT00189475|E2|Reported Event|Placebo|Treated for 4 months with placebo
715799|NCT00189475|E1|Reported Event|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
715800|NCT00189462|B3|Baseline|Total|Total of all reporting groups
715801|NCT00189462|B2|Baseline|Placebo|Treatment with placebo for 4 months
715802|NCT00189462|B1|Baseline|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
715803|NCT00189462|P2|Participant Flow|Placebo|Treatment with placebo for 4 months
715804|NCT00189462|P1|Participant Flow|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
715805|NCT00189462|O2|Outcome|Placebo|Treatment with placebo for 4 months
715806|NCT00189462|O1|Outcome|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
715807|NCT00189462|E2|Reported Event|Placebo|Treatment with placebo for 4 months
715808|NCT00189462|E1|Reported Event|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
715809|NCT00189436|B3|Baseline|Total|Total of all reporting groups
715810|NCT00189436|B2|Baseline|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
715811|NCT00189436|B1|Baseline|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
715812|NCT00189436|P2|Participant Flow|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
715813|NCT00189436|P1|Participant Flow|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
715814|NCT00189436|O2|Outcome|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
715815|NCT00189436|O1|Outcome|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
715816|NCT00189436|E2|Reported Event|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
715817|NCT00189436|E1|Reported Event|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
715818|NCT00189423|B3|Baseline|Total|Total of all reporting groups
715819|NCT00189423|B2|Baseline|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715820|NCT00189423|B1|Baseline|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715821|NCT00189423|P2|Participant Flow|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715822|NCT00189423|P1|Participant Flow|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715823|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715824|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715825|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715827|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715828|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715829|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715830|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715831|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715832|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715833|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715834|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715835|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715836|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715837|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715838|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715839|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715840|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715841|NCT00189423|E2|Reported Event|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
715842|NCT00189423|E1|Reported Event|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
715843|NCT00189306|B1|Baseline|Aldara|Aldara (imiquimod) cream 5%
715844|NCT00189306|P1|Participant Flow|Aldara|Aldara (imiquimod) cream 5%
715845|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
715846|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
715847|NCT00189306|E1|Reported Event|Aldara|Aldara (imiquimod) cream 5%
715848|NCT00189202|B1|Baseline|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715849|NCT00189202|P1|Participant Flow|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715850|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715851|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715852|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715853|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715854|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715855|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715856|NCT00189202|E1|Reported Event|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
715857|NCT00189137|B3|Baseline|Total|Total of all reporting groups
715858|NCT00189137|B2|Baseline|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715859|NCT00189137|B1|Baseline|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715860|NCT00189137|P2|Participant Flow|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715861|NCT00189137|P1|Participant Flow|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715862|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715863|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715864|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715865|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715866|NCT00189137|E2|Reported Event|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715867|NCT00189137|E1|Reported Event|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
715868|NCT00189098|B3|Baseline|Total|Total of all reporting groups
715869|NCT00189098|B2|Baseline|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
715870|NCT00189098|B1|Baseline|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
715871|NCT00189098|P2|Participant Flow|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
715872|NCT00189098|P1|Participant Flow|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
715873|NCT00189098|O2|Outcome|Placebo|
715874|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
715875|NCT00189098|O2|Outcome|Placebo|
715876|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
715877|NCT00189098|O2|Outcome|Placebo|
715878|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
715879|NCT00189098|O2|Outcome|Placebo|
715880|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
715881|NCT00189098|O2|Outcome|Placebo|
715882|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
715883|NCT00189098|O2|Outcome|Placebo|The children in this group received placebo orally two times a day for 6 to 12 weeks.
715884|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.
715885|NCT00189098|E2|Reported Event|Placebo|
715886|NCT00189098|E1|Reported Event|Sulfamethoxazole-trimethoprim|
715887|NCT00187889|B3|Baseline|Total|Total of all reporting groups
715888|NCT00187889|B2|Baseline|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
715889|NCT00187889|B1|Baseline|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
715967|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
715890|NCT00187889|P2|Participant Flow|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
715891|NCT00187889|P1|Participant Flow|Eplerenone|Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
715892|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
715893|NCT00187889|O1|Outcome|EPLERENONE|Active Drug
715894|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
715895|NCT00187889|O1|Outcome|EPLERINONE|Active drug
715896|NCT00187889|E2|Reported Event|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
715897|NCT00187889|E1|Reported Event|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
715898|NCT00187876|B3|Baseline|Total|Total of all reporting groups
715899|NCT00187876|B2|Baseline|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
715900|NCT00187876|B1|Baseline|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
715901|NCT00187876|P2|Participant Flow|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
715902|NCT00187876|P1|Participant Flow|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that are non- irradiated aseptically, processed BTB allografts."
715903|NCT00187876|O2|Outcome|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
715904|NCT00187876|O1|Outcome|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
715905|NCT00187876|E2|Reported Event|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
715906|NCT00187876|E1|Reported Event|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using asceptic patellar tendon allografts."
715907|NCT00187720|B3|Baseline|Total|Total of all reporting groups
715908|NCT00187720|B2|Baseline|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
715909|NCT00187720|B1|Baseline|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
715910|NCT00187720|P2|Participant Flow|Organic Cation Transporter 2 (OCT2)-Reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
715911|NCT00187720|P1|Participant Flow|Organic Cation Transporter 2 (OCT2)-Variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
715912|NCT00187720|O2|Outcome|OCT2-reference Group|The renal clearance of metformin in subjects homozygous for the reference OCT2 genotype (808G/G) following a single oral dose of 850 mg of metformin.
715913|NCT00187720|O1|Outcome|OCT2-variant Group|The renal clearance of metformin in subjects heterozygous for the variant OCT2 genotype (808G/T, *3D) following a single oral dose of 850 mg of metformin.
715914|NCT00187720|E2|Reported Event|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
715915|NCT00187720|E1|Reported Event|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
715916|NCT00187681|B3|Baseline|Total|Total of all reporting groups
715917|NCT00187681|B2|Baseline|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
715918|NCT00187681|B1|Baseline|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
715919|NCT00187681|P2|Participant Flow|Organic Cation Transporter 1 (OCT1)-Reference Group|Subjects with OCT1-reference alleles to be dosed with 2 doses of Metformin (total 1850 mg).
715920|NCT00187681|P1|Participant Flow|Organic Cation Transporter 1 (OCT1)-Variant Group|Subjects with OCT1-variant alleles to be dosed with 2 doses of Metformin (total 1850 mg).
715921|NCT00187681|O2|Outcome|OCT1-reference Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying the reference OCT1 genotype at all the four positions in the OCT1 gene.
715922|NCT00187681|O1|Outcome|OCT1-variant Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying variant OCT1 genotypes (ie. carries at least one of four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
715923|NCT00187681|O2|Outcome|OCT1-reference Group|Metformin blood concentration-time profiles in subjects carrying the reference OCT1 allele at all the four positions in the OCT1 gene.
715924|NCT00187681|O1|Outcome|OCT1-variant Group|Metformin blood concentration-time profiles in subjects carrying the variant OCT1 genotypes (ie. carries at least one of the four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
715925|NCT00187681|E2|Reported Event|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
715968|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
715926|NCT00187681|E1|Reported Event|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
715927|NCT00187655|B1|Baseline|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
715928|NCT00187655|P1|Participant Flow|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
715929|NCT00187655|O2|Outcome|Homozygous for OAT3-Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as homozygous for the Ile305Phe variant and compared to volunteers that were heterozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
715930|NCT00187655|O1|Outcome|Heterozygous for the Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as heterozygous for the Ile305Phe variant and compared to volunteers that were homozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
715931|NCT00187655|E1|Reported Event|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
715932|NCT00187486|B1|Baseline|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
715933|NCT00187486|P1|Participant Flow|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
715934|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
715935|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
715936|NCT00187486|E1|Reported Event|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
715937|NCT00187226|B7|Baseline|Total|Total of all reporting groups
715938|NCT00187226|B6|Baseline|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
715939|NCT00187226|B5|Baseline|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
715940|NCT00187226|B4|Baseline|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
715941|NCT00187226|B3|Baseline|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
715942|NCT00187226|B2|Baseline|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
715943|NCT00187226|B1|Baseline|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
715944|NCT00187226|P6|Participant Flow|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
715945|NCT00187226|P5|Participant Flow|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
715946|NCT00187226|P4|Participant Flow|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
715947|NCT00187226|P3|Participant Flow|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
715948|NCT00187226|P2|Participant Flow|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
715949|NCT00187226|P1|Participant Flow|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
715950|NCT00187226|O6|Outcome|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
715951|NCT00187226|O5|Outcome|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
715952|NCT00187226|O4|Outcome|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
715953|NCT00187226|O3|Outcome|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
715954|NCT00187226|O2|Outcome|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
715955|NCT00187226|O1|Outcome|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
715956|NCT00187226|E6|Reported Event|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
715957|NCT00187226|E5|Reported Event|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
715958|NCT00187226|E4|Reported Event|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
715959|NCT00187226|E3|Reported Event|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
715960|NCT00187226|E2|Reported Event|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
715961|NCT00187226|E1|Reported Event|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
715962|NCT00187200|B3|Baseline|Total|Total of all reporting groups
715963|NCT00187200|B2|Baseline|Sequential VV Pacing|V-V delay was optimized
715964|NCT00187200|B1|Baseline|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
715965|NCT00187200|P2|Participant Flow|Sequential VV Pacing|V-V delay was optimized
715966|NCT00187200|P1|Participant Flow|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
715970|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
715971|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
715972|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
715973|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized per protocol
715974|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay per protocol
715975|NCT00187200|E2|Reported Event|Sequential VV Pacing|V-V delay was optimized
715976|NCT00187200|E1|Reported Event|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
715977|NCT00187135|B7|Baseline|Total|Total of all reporting groups
715978|NCT00187135|B6|Baseline|Fentanyl 1/Placebo/Fentanyl 0.5|
715979|NCT00187135|B5|Baseline|Fentanyl 1/Fentanyl 0.5/Placebo|
715980|NCT00187135|B4|Baseline|Placebo/Fentanyl 1/Fentanyl 0.5|
715981|NCT00187135|B3|Baseline|Placebo/Fentanyl 0.5/Fentanyl 1|
715982|NCT00187135|B2|Baseline|Fentanyl 0.5/Fentanyl 1/Placebo|
715983|NCT00187135|B1|Baseline|Fentanyl 0.5/Placebo/Fentanyl 1|
715984|NCT00187135|P6|Participant Flow|Fentanyl 1 / Placebo /Fentanyl 0.5|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
715985|NCT00187135|P5|Participant Flow|Fentanyl 1 / Fentanyl 0.5 / Placebo|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
715986|NCT00187135|P4|Participant Flow|Placebo /Fentanyl 1 / Fentanyl 0.5|Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
715987|NCT00187135|P3|Participant Flow|Placebo / Fentanyl 0.5 /Fentanyl 1|Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit.
715988|NCT00187135|P2|Participant Flow|Fentanyl 0.5 /Fentanyl 1 / Placebo|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
715989|NCT00187135|P1|Participant Flow|Fentanyl 0.5 / Placebo / Fentanyl 1|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit.
715990|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
715991|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
715992|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
715993|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
715994|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
715995|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
715996|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
715997|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
715998|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
715999|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
716000|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
716001|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
716002|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg vs Fentanyl 1mcg/kg|Patients who completed treatment with Fentanyl 0.5 mcg/kg and Fentanyl 1mcg/kg.
716003|NCT00187135|O2|Outcome|Fentanyl 0.5mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
716004|NCT00187135|O1|Outcome|Fentanyl 1mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
716005|NCT00187135|E3|Reported Event|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
719155|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
716006|NCT00187135|E2|Reported Event|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1.0 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
716007|NCT00187135|E1|Reported Event|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
716008|NCT00187096|B4|Baseline|Total|Total of all reporting groups
716009|NCT00187096|B3|Baseline|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716010|NCT00187096|B2|Baseline|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716011|NCT00187096|B1|Baseline|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716012|NCT00187096|P3|Participant Flow|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716013|NCT00187096|P2|Participant Flow|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716014|NCT00187096|P1|Participant Flow|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|Participants with AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716015|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716016|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716017|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716018|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716019|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716020|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716021|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716022|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716023|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716068|NCT00186901|O1|Outcome|Placebo - (QCT)|91 patients were assessed at 24 months using the QCT scan.
716024|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716025|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716026|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716027|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716028|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716029|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716030|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716031|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716032|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716033|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716034|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716035|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716036|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716037|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716038|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716069|NCT00186901|O4|Outcome|Supplement - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
716039|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716040|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716041|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716042|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716043|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716044|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716045|NCT00187096|E3|Reported Event|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
716046|NCT00187096|E2|Reported Event|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
716047|NCT00187096|E1|Reported Event|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
716048|NCT00186901|B4|Baseline|Total|Total of all reporting groups
716049|NCT00186901|B3|Baseline|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
716050|NCT00186901|B2|Baseline|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
716051|NCT00186901|B1|Baseline|Placebo Group|Nutritional counseling + placebo
716052|NCT00186901|P3|Participant Flow|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
716053|NCT00186901|P2|Participant Flow|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
716054|NCT00186901|P1|Participant Flow|Placebo Group|Nutritional counseling + placebo
716055|NCT00186901|O3|Outcome|Bsm - bb Genotype|The bb genotype was observed in 77 (18.47%) out of 417 participants, with a median BMD Z score of -0.17.
716056|NCT00186901|O2|Outcome|Bsm - Bb Genotype|The Bb genotype was observed in 65 (15.59%) out of 417 participants, with a median BMD Z score of -0.17.
716057|NCT00186901|O1|Outcome|Bsm - BB Genotype|The BB genotype was observed in 41 (09.83%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.5.
716058|NCT00186901|O3|Outcome|Apa 1 - aa Genotype|The aa genotype was present in 49 (11.75%) out of 417 participants, with a median BMD Z score of -0.57.
716059|NCT00186901|O2|Outcome|Apa 1 - Aa Genotype|The Aa genotype was observed in 104 (24.94%) out of 417 participants, with a median BMD Z score of -0.44.
716060|NCT00186901|O1|Outcome|Apa 1 - AA Genotype|The AA genotype was observed in 68 (16.31%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.56.
716061|NCT00186901|O4|Outcome|Supplement - (DXA)|53 of the 96 patients assessed at 36 months also had a DXA scan.
716062|NCT00186901|O3|Outcome|Supplement - (QCT)|96 patients were assessed at 36 months using the QCT scan.
716063|NCT00186901|O2|Outcome|Placebo - (DXA)|36 of the 84 patients assessed at 36 months also had a DXA scan.
716064|NCT00186901|O1|Outcome|Placebo - (QCT)|84 patients were assessed at 36 months using the QCT scan.
716065|NCT00186901|O4|Outcome|Supplement - (DXA)|51 of the 97 patients assessed at 24 months also had a DXA scan.
716066|NCT00186901|O3|Outcome|Supplement - (QCT)|97 patients were assessed at 24 months using the QCT scan.
716067|NCT00186901|O2|Outcome|Placebo - (DXA)|39 of the 91 patients assessed at 24 months also had a DXA scan.
716070|NCT00186901|O3|Outcome|Supplement - (QCT)|109 patients were assessed at 12 months using the QCT scan.
716071|NCT00186901|O2|Outcome|Placebo - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
716072|NCT00186901|O1|Outcome|Placebo - (QCT)|109 patients were assessed at 12 months using the QCT scan.
716073|NCT00186901|O4|Outcome|Supplement - (DXA)|61 of the 141 baseline patients also had a DXA scan.
716074|NCT00186901|O3|Outcome|Supplement - (QCT)|141 patients were assessed at baseline using the QCT scan.
716075|NCT00186901|O2|Outcome|Placebo - (DXA)|60 of the 134 baseline patients also had a DXA scan.
716076|NCT00186901|O1|Outcome|Placebo - (QCT)|134 patients were assessed at baseline using the QCT scan.
716077|NCT00186901|O4|Outcome|Above 22 Years|113 patients greater than 22 years of age were eligible for the study
716078|NCT00186901|O3|Outcome|18 to 22 Years|74 patients between the ages of 18 and 22 were eligible for the study
716079|NCT00186901|O2|Outcome|13 to 18 Years|139 patients between the ages of 13 and 18 were eligible for the study
716080|NCT00186901|O1|Outcome|9 to 13 Years|98 patients between the ages of 9 and 13 were eligible for the study
716081|NCT00186901|O2|Outcome|Non-white|59 non-white were eligible for the study
716082|NCT00186901|O1|Outcome|White|365 white patients were eligible for the study
716083|NCT00186901|O2|Outcome|Female|206 females were eligible for the study
716084|NCT00186901|O1|Outcome|Male|218 males were eligible for the study
716085|NCT00186901|O2|Outcome|Supplement|CVD Supplement Group (Experimental 1B): Patients who received calcium and vitamin D supplementation.
716086|NCT00186901|O1|Outcome|Placebo|Placebo Group (Placebo Comparator 1A): Patients who received placebo pills.
716087|NCT00186901|E3|Reported Event|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
716088|NCT00186901|E2|Reported Event|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
716089|NCT00186901|E1|Reported Event|Placebo Group|Nutritional counseling + placebo
716090|NCT00186888|B4|Baseline|Total|Total of all reporting groups
716091|NCT00186888|B3|Baseline|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
716092|NCT00186888|B2|Baseline|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716093|NCT00186888|B1|Baseline|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
716094|NCT00186888|P3|Participant Flow|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
716095|NCT00186888|P2|Participant Flow|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716096|NCT00186888|P1|Participant Flow|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
716097|NCT00186888|O3|Outcome|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
716098|NCT00186888|O2|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716099|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
716100|NCT00186888|O2|Outcome|Occupational Therapy Did Not Recommend Rehabilitation Services|Occupational therapy evaluation did not recommend rehabilitation services.
716101|NCT00186888|O1|Outcome|Occupational Therapy Recommended Rehabilitation Services|Occupational therapy evaluation recommended rehabilitation services.
716102|NCT00186888|O3|Outcome|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
716103|NCT00186888|O2|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716188|NCT00186628|P1|Participant Flow|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716104|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
716105|NCT00186888|O3|Outcome|Additional Evaluation|All Stratum B participants with non-missing observation values were included. Stratum B (Advanced Bilateral retinoblastoma) includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716106|NCT00186888|O2|Outcome|Interim Evaluation|All Stratum B participants with non-missing observation values were included. Stratum B (Advanced Bilateral retinoblastoma) includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716107|NCT00186888|O1|Outcome|Baseline|All Stratum B participants with non-missing observation values were included. Stratum B (Advanced Bilateral retinoblastoma) includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716108|NCT00186888|O1|Outcome|Participants With Bilateral Retinoblastoma|Results were analyzed for all participants regardless of stratum. All participants received chemotherapy (5 Stratum C, high risk; 11 Stratum A; 27 Stratum B).
716109|NCT00186888|O1|Outcome|Participants With Bilateral Retinoblastoma|Results were analyzed for all participants regardless of stratum. All participants received chemotherapy (5 Stratum C, high risk; 11 Stratum A; 27 Stratum B).
716110|NCT00186888|O1|Outcome|5 Years|Participant age was 5 years ±3 months.
716111|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
716112|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
716113|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
716114|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
716115|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
716116|NCT00186888|O1|Outcome|Baseline|At study entry.
716117|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
716118|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
716119|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
716120|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
716121|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
716122|NCT00186888|O1|Outcome|Baseline|At study entry.
716123|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
716124|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
716125|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
716126|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
716127|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
716128|NCT00186888|O1|Outcome|Baseline|At study entry.
716129|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
716130|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
716131|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
716132|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
716133|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
716134|NCT00186888|O1|Outcome|Baseline|At study entry.
716135|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716136|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716137|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716164|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716265|NCT00186043|B1|Baseline|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
716138|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716139|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716140|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716141|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716142|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716143|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716144|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716145|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC=A and B) and advanced (IC=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716146|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716147|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716148|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716187|NCT00186628|B1|Baseline|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716149|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716150|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
716151|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716152|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716153|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
716154|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
716155|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716156|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716157|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716158|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716159|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716160|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716161|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716162|NCT00186888|O1|Outcome|Stratum B|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~Two patients (3 eyes) in stratum B received external beam radiation therapy (EBRT), and the same 2 patients later required enucleation of the treated eye, thus the failure (event number) and censoring status were not changed for the 2 patients."
716163|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716266|NCT00186043|P2|Participant Flow|Placebo|Placebo
716267|NCT00186043|P1|Participant Flow|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
716165|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716166|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716167|NCT00186888|E3|Reported Event|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
716168|NCT00186888|E2|Reported Event|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
716169|NCT00186888|E1|Reported Event|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
716170|NCT00186875|B3|Baseline|Total|Total of all reporting groups
716171|NCT00186875|B2|Baseline|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
716172|NCT00186875|B1|Baseline|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
716173|NCT00186875|P2|Participant Flow|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
716174|NCT00186875|P1|Participant Flow|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
716175|NCT00186875|O3|Outcome|TOTXV Participants|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy. Participants received high-dose methotrexate infusion in upfront window treatment as described in NCT00137111.
716176|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
716177|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
716178|NCT00186875|O3|Outcome|TOTXV Participants|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy. Participants received high-dose methotrexate infusion in upfront window treatment as described in NCT00137111.
716179|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
716180|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
716181|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
716182|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
716183|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
716184|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
716185|NCT00186875|E2|Reported Event|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
716186|NCT00186875|E1|Reported Event|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
716268|NCT00186043|O2|Outcome|Placebo|Placebo comparator
716269|NCT00186043|O1|Outcome|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
716189|NCT00186628|O2|Outcome|Prophylactic Rituximab (MCL Patients)|MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716190|NCT00186628|O1|Outcome|Prophylactic Rituximab (CLL Patients)|CLL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716191|NCT00186628|O1|Outcome|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716192|NCT00186628|O1|Outcome|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716193|NCT00186628|O1|Outcome|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716194|NCT00186628|E1|Reported Event|Prophylactic Rituximab|Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
716195|NCT00186537|B4|Baseline|Total|Total of all reporting groups
716196|NCT00186537|B3|Baseline|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
716197|NCT00186537|B2|Baseline|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
716198|NCT00186537|B1|Baseline|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
716199|NCT00186537|P3|Participant Flow|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
716200|NCT00186537|P2|Participant Flow|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
716201|NCT00186537|P1|Participant Flow|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
716202|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
716203|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
716204|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
716205|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
716206|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
716207|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
716208|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
716209|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
716210|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
716211|NCT00186537|E3|Reported Event|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
716212|NCT00186537|E2|Reported Event|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
716213|NCT00186537|E1|Reported Event|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
716214|NCT00186485|B1|Baseline|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
716215|NCT00186485|P1|Participant Flow|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
716216|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
716217|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
716218|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
716219|NCT00186485|E1|Reported Event|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
716220|NCT00186446|B1|Baseline|Bupropion and Smoking Cessation Behavioral Intervention|
716221|NCT00186446|P1|Participant Flow|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
716222|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|bupropion and behavioral intervention
716223|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
716224|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|
716225|NCT00186446|E1|Reported Event|Bupropion and Smoking Cessation Behavioral Intervention|
716226|NCT00186186|B1|Baseline|Depakote ER|"Depakote ER up to 1500 mg/day~Depakote ER: Depakote ER"
716227|NCT00186186|P1|Participant Flow|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
716228|NCT00186186|O1|Outcome|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
716229|NCT00186186|O1|Outcome|Depakote ER|Depakote ER up to 1500 mg/day
716230|NCT00186186|E1|Reported Event|Depakote ER|Depakote ER up to 1500 mg/day
716270|NCT00186043|O2|Outcome|Placebo|Placebo comparator
716271|NCT00186043|O1|Outcome|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
716231|NCT00186121|B1|Baseline|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.
716232|NCT00186121|P1|Participant Flow|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.
716233|NCT00186121|O1|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716234|NCT00186121|O1|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716235|NCT00186121|O1|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716236|NCT00186121|O1|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716237|NCT00186121|O1|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716238|NCT00186121|O1|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716239|NCT00186121|O1|Outcome|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716240|NCT00186121|E1|Reported Event|Anastrozole + Goserelin|Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.
716241|NCT00186069|B3|Baseline|Total|Total of all reporting groups
716242|NCT00186069|B2|Baseline|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
716243|NCT00186069|B1|Baseline|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
716244|NCT00186069|P2|Participant Flow|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
716245|NCT00186069|P1|Participant Flow|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
716246|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
716247|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
716248|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
716249|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
716250|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
716251|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
716252|NCT00186069|E2|Reported Event|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
716253|NCT00186069|E1|Reported Event|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
716254|NCT00186056|B3|Baseline|Total|Total of all reporting groups
716255|NCT00186056|B2|Baseline|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
716256|NCT00186056|B1|Baseline|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
716257|NCT00186056|P2|Participant Flow|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
716258|NCT00186056|P1|Participant Flow|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
716259|NCT00186056|O2|Outcome|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
716260|NCT00186056|O1|Outcome|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
716261|NCT00186056|E2|Reported Event|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
716262|NCT00186056|E1|Reported Event|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
716263|NCT00186043|B3|Baseline|Total|Total of all reporting groups
716264|NCT00186043|B2|Baseline|Placebo|Placebo
716273|NCT00186043|O1|Outcome|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
716274|NCT00186043|E2|Reported Event|Placebo|"Placebo~Quetiapine/Seroquel: Quetiapine/Seroquel"
716275|NCT00186043|E1|Reported Event|Quetiapine/Seroquel|"Quetiapine/Seroquel up to 800 mg/day~Quetiapine/Seroquel: Quetiapine/Seroquel"
716276|NCT00186017|B3|Baseline|Total|Total of all reporting groups
716277|NCT00186017|B2|Baseline|Placebo|"Placebo~Olanzapine/Zyprexa"
716278|NCT00186017|B1|Baseline|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa"
716279|NCT00186017|P2|Participant Flow|Placebo|"Placebo~Olanzapine/Zyprexa"
716280|NCT00186017|P1|Participant Flow|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa"
716281|NCT00186017|O2|Outcome|Placebo|Placebo
716282|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
716283|NCT00186017|O2|Outcome|Placebo|Placebo
716284|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
716285|NCT00186017|O2|Outcome|Placebo|Placebo
716286|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
716287|NCT00186017|O2|Outcome|Placebo|Placebo up to 8 per day for 1 week
716288|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
716289|NCT00186017|E2|Reported Event|Placebo|Placebo taken in same manner as study drug up to 8 per day for 1 week
716290|NCT00186017|E1|Reported Event|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
716291|NCT00185965|B3|Baseline|Total|Total of all reporting groups
716292|NCT00185965|B2|Baseline|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716293|NCT00185965|B1|Baseline|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716294|NCT00185965|P2|Participant Flow|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716295|NCT00185965|P1|Participant Flow|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716296|NCT00185965|O2|Outcome|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716297|NCT00185965|O1|Outcome|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716298|NCT00185965|E2|Reported Event|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716299|NCT00185965|E1|Reported Event|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
716300|NCT00185731|B1|Baseline|Atorvastatin|Atorvastatin, 80mg tablet, orally once daily.
716301|NCT00185731|P1|Participant Flow|Atorvastatin|Atorvastatin, 80mg tablet, orally once daily.
716302|NCT00185731|O1|Outcome|80 mg Atorvastatin|"Atorvastatin, 80 mg tablet, was taken orally by the patient daily, beginning on study day 1.~Atorvastatin: 80 mg orally once daily"
716303|NCT00185731|O1|Outcome|80 mg|"Atorvastatin, 80 mg tablet, was taken orally by the patient daily, beginning on study day 1.~Atorvastatin: 80 mg orally once daily"
716304|NCT00185731|O1|Outcome|Atorvastatin|"Atorvastatin, 80mg tablet, was taken orally by the patient daily, beginning on study day 1.~Atorvastatin: 80 mg orally once daily"
716305|NCT00185731|E1|Reported Event|Atorvastatin|Atorvastatin, 80mg tablet, orally once daily.
716306|NCT00185692|B1|Baseline|Transplating of CD34+ Selected Hematopietic Cells|
716307|NCT00185692|P1|Participant Flow|Transplating of CD34+ Selected Hematopietic Cells|
716323|NCT00185640|O1|Outcome|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg BID; IV or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; SQ"
716324|NCT00185640|O1|Outcome|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg BID; IV or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; SQ"
716782|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
716308|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.~Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.~non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.~Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.~Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.~Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).~Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
716309|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.~Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.~non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.~Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.~Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.~Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).~Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
716310|NCT00185692|E1|Reported Event|Transplating of CD34+ Selected Hematopietic Cells|
716311|NCT00185679|B1|Baseline|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
716312|NCT00185679|P1|Participant Flow|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
716313|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
716314|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
716315|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
716316|NCT00185679|E1|Reported Event|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
716317|NCT00185640|B1|Baseline|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg BID; IV or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; SQ"
716318|NCT00185640|P1|Participant Flow|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg twice-a-day (BID); intravenous (IV) or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; subcutaneous (SQ)"
716319|NCT00185640|O1|Outcome|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg BID; IV or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; SQ"
716320|NCT00185640|O1|Outcome|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg BID; IV or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; SQ"
716321|NCT00185640|O1|Outcome|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg BID; IV or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; SQ"
716322|NCT00185640|O1|Outcome|Non-myeloablative Transplantation|"Cyclosporine: 3 to 5 mg/kg BID; IV or oral~Thymoglobulin: 7.5 to 10 mg/kg; IV~Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours~G-CSF: 16 mcg/kg; SQ"
716401|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716325|NCT00185640|E1|Reported Event|Non-myeloablative Transplantation|Per the Common Rule, adverse events other than death, secondary malignancy, or relapse were not collected.
716326|NCT00185614|B1|Baseline|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716327|NCT00185614|P1|Participant Flow|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716328|NCT00185614|O1|Outcome|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716329|NCT00185614|O1|Outcome|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716330|NCT00185614|O1|Outcome|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716331|NCT00185614|O1|Outcome|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716332|NCT00185614|O1|Outcome|Auto- Then Allo-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716402|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716644|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
716333|NCT00185614|E1|Reported Event|All Participants Receviing at Least Auto-HCT|Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
716334|NCT00185588|B5|Baseline|Total|Total of all reporting groups
716335|NCT00185588|B4|Baseline|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716336|NCT00185588|B3|Baseline|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716337|NCT00185588|B2|Baseline|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716338|NCT00185588|B1|Baseline|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716339|NCT00185588|P4|Participant Flow|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716340|NCT00185588|P3|Participant Flow|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716341|NCT00185588|P2|Participant Flow|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716342|NCT00185588|P1|Participant Flow|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716343|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716344|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716345|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716346|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716347|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716348|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716349|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716350|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716351|NCT00185588|E4|Reported Event|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716352|NCT00185588|E3|Reported Event|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716353|NCT00185588|E2|Reported Event|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716354|NCT00185588|E1|Reported Event|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
716355|NCT00185458|B1|Baseline|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
716446|NCT00185211|B3|Baseline|Total|Total of all reporting groups
716649|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|250 mg given on day 1, administered by IM Injection
716356|NCT00185458|P1|Participant Flow|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
716357|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716358|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716359|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716360|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716361|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716362|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716363|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716364|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716365|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716366|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716367|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716368|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716369|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716370|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716371|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716372|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716373|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716374|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716375|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716376|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716377|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716378|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716379|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716380|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716381|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716382|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716383|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716384|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716385|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716386|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716387|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716388|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716389|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716390|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716391|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716392|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716393|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716394|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716395|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716396|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716397|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
716398|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
716399|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
716400|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
716403|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
716404|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
716405|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
716406|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
716407|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
716408|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
716409|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
716410|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
716411|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
716412|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
716413|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
716414|NCT00185458|E1|Reported Event|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
716415|NCT00185380|B4|Baseline|Total|Total of all reporting groups
716416|NCT00185380|B3|Baseline|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716417|NCT00185380|B2|Baseline|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716418|NCT00185380|B1|Baseline|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716419|NCT00185380|P3|Participant Flow|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716420|NCT00185380|P2|Participant Flow|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716421|NCT00185380|P1|Participant Flow|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716422|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716423|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716424|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716425|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716426|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716427|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716428|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716429|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716430|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716431|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716432|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716433|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716434|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716435|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716436|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716437|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716438|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716439|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716440|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716441|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716442|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716443|NCT00185380|E3|Reported Event|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
716444|NCT00185380|E2|Reported Event|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
716445|NCT00185380|E1|Reported Event|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
716447|NCT00185211|B2|Baseline|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716448|NCT00185211|B1|Baseline|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716449|NCT00185211|P2|Participant Flow|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716450|NCT00185211|P1|Participant Flow|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716451|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716452|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716453|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716454|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716455|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716456|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716457|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716458|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716459|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716460|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716461|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716462|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716463|NCT00185211|O1|Outcome|All Subjects|All subjects part of Intention-To-Treat (ITT) Population
716464|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716465|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716466|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716467|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716468|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716469|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716470|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716471|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716472|NCT00185211|E2|Reported Event|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
716473|NCT00185211|E1|Reported Event|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
716474|NCT00184717|B4|Baseline|Total|Total of all reporting groups
716475|NCT00184717|B3|Baseline|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
716476|NCT00184717|B2|Baseline|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716477|NCT00184717|B1|Baseline|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716478|NCT00184717|P5|Participant Flow|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716479|NCT00184717|P4|Participant Flow|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716480|NCT00184717|P3|Participant Flow|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
716481|NCT00184717|P2|Participant Flow|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716482|NCT00184717|P1|Participant Flow|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716483|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716484|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716485|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716486|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716487|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716488|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716489|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716490|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716491|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716492|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716493|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716494|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716495|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716496|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716497|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716498|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716499|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716500|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716501|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716502|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716503|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716504|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716505|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716506|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716507|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716508|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716509|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716510|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716511|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716512|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
716513|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716514|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
716515|NCT00184717|E4|Reported Event|0.067 mg / No Treatment|
716516|NCT00184717|E3|Reported Event|0.033 mg / No Treatment|
716517|NCT00184717|E2|Reported Event|0.067 mg / NN-220|
716518|NCT00184717|E1|Reported Event|0.033 mg / NN-220|
716519|NCT00184600|B4|Baseline|Total|Total of all reporting groups
716520|NCT00184600|B3|Baseline|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716521|NCT00184600|B2|Baseline|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716522|NCT00184600|B1|Baseline|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716523|NCT00184600|P3|Participant Flow|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716614|NCT00184548|E1|Reported Event|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716650|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|20 mg given by mouth daily for 21 days
716524|NCT00184600|P2|Participant Flow|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716525|NCT00184600|P1|Participant Flow|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716526|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716527|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716528|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716529|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716530|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716531|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716615|NCT00184093|B1|Baseline|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
716645|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
716532|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716533|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716534|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716535|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716536|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716537|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716538|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716539|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716616|NCT00184093|P1|Participant Flow|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
716617|NCT00184093|O1|Outcome|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
716540|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716541|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716542|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716543|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716544|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716545|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716546|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716547|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716618|NCT00184093|O1|Outcome|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
716646|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
716548|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716549|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716550|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716551|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716552|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716553|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716554|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716555|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716619|NCT00184093|E1|Reported Event|Gemcitabine Weekly x 6 Wks With Concurrent External Radiation|"Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation~Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation"
716647|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
716651|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
716556|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716557|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716558|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716559|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716560|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716561|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716562|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716563|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716620|NCT00184054|B1|Baseline|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
716621|NCT00184054|P1|Participant Flow|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
716564|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716565|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716566|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716567|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716568|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716569|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716570|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716571|NCT00184600|E3|Reported Event|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
716622|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
716648|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|500 mg given on day 1, administered by IM Injection
716572|NCT00184600|E2|Reported Event|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
716573|NCT00184600|E1|Reported Event|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
716574|NCT00184548|B5|Baseline|Total|Total of all reporting groups
716575|NCT00184548|B4|Baseline|Placebo, Penetrating Trauma|
716576|NCT00184548|B3|Baseline|rFVIIa, Penetrating Trauma|
716577|NCT00184548|B2|Baseline|Placebo, Blunt Trauma|
716578|NCT00184548|B1|Baseline|rFVIIa, Blunt Trauma|
716579|NCT00184548|P4|Participant Flow|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716580|NCT00184548|P3|Participant Flow|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716581|NCT00184548|P2|Participant Flow|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716582|NCT00184548|P1|Participant Flow|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716583|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
716584|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
716585|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
716586|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
716587|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
716588|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
716589|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
716590|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
716591|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
716592|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
716593|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
716594|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
716595|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
716596|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
716597|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
716598|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
716599|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
716600|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
716601|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
716602|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
716603|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
716604|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
716605|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
716606|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
716607|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
716608|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
716609|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
716610|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
716611|NCT00184548|E4|Reported Event|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716612|NCT00184548|E3|Reported Event|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716613|NCT00184548|E2|Reported Event|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
716623|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
716624|NCT00184054|E1|Reported Event|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
716625|NCT00184028|B1|Baseline|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
716626|NCT00184028|P1|Participant Flow|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
716627|NCT00184028|O1|Outcome|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
716628|NCT00184028|O1|Outcome|Arm 1|Single arm study
716629|NCT00184028|E1|Reported Event|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
716630|NCT00184002|B1|Baseline|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).~Prednisone 100 mg po days 1-5.~Cycle 2 until study completion~Doxil 40 mg/m2 iv day 1~Rituxan 375 mg/m2 iv day 1~Cyclophosphamide 750 mg/m2 iv day 1"
716631|NCT00184002|P1|Participant Flow|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).~Prednisone 100 mg po days 1-5.~Cycle 2 until study completion~Doxil 40 mg/m2 iv day 1~Rituxan 375 mg/m2 iv day 1~Cyclophosphamide 750 mg/m2 iv day 1"
716632|NCT00184002|O1|Outcome|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).~Prednisone 100 mg po days 1-5.~Cycle 2 until study completion~Doxil 40 mg/m2 iv day 1~Rituxan 375 mg/m2 iv day 1~Cyclophosphamide 750 mg/m2 iv day 1"
716633|NCT00184002|O1|Outcome|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.~Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.~Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).~Prednisone 100 mg po days 1-5.~Cycle 2 until study completion~Doxil 40 mg/m2 iv day 1~Rituxan 375 mg/m2 iv day 1~Cyclophosphamide 750 mg/m2 iv day 1"
716634|NCT00184002|E1|Reported Event|DR-COP|"On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.~On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5~1 cycle = 21 days.~Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.~Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5.~Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1"
716635|NCT00183963|B5|Baseline|Total|Total of all reporting groups
716636|NCT00183963|B4|Baseline|Arm 4: High Dose Fulvestrant|
716637|NCT00183963|B3|Baseline|Arm 3: Low Dose Fulvestrant|
716638|NCT00183963|B2|Baseline|Arm 2: Tamoxifen Group|
716639|NCT00183963|B1|Baseline|Arm 1: Control Group|
716640|NCT00183963|P4|Participant Flow|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
716641|NCT00183963|P3|Participant Flow|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
716642|NCT00183963|P2|Participant Flow|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
716643|NCT00183963|P1|Participant Flow|Arm 1: Control Group|Placebo
716652|NCT00183963|E4|Reported Event|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
716653|NCT00183963|E3|Reported Event|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
716654|NCT00183963|E2|Reported Event|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
716655|NCT00183963|E1|Reported Event|Arm 1: Control Group|Placebo
716656|NCT00183872|B1|Baseline|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
716657|NCT00183872|P1|Participant Flow|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
716658|NCT00183872|O1|Outcome|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
716659|NCT00183872|O1|Outcome|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
716660|NCT00183872|E1|Reported Event|Arm 1 - Irinotecan and Docetaxel|"Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days~irinotecan, docetaxel: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8."
716661|NCT00183794|B1|Baseline|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
716662|NCT00183794|P1|Participant Flow|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
716663|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
716664|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
716665|NCT00183794|E1|Reported Event|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
716666|NCT00183729|B3|Baseline|Total|Total of all reporting groups
716667|NCT00183729|B2|Baseline|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
716668|NCT00183729|B1|Baseline|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
716669|NCT00183729|P2|Participant Flow|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
716670|NCT00183729|P1|Participant Flow|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
716671|NCT00183729|O2|Outcome|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
716672|NCT00183729|O1|Outcome|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
716673|NCT00183729|O2|Outcome|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
716674|NCT00183729|O1|Outcome|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
716675|NCT00183729|O2|Outcome|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
716676|NCT00183729|O1|Outcome|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
716677|NCT00183729|E2|Reported Event|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
716678|NCT00183729|E1|Reported Event|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
716679|NCT00183677|B1|Baseline|Open Label Escitalopram|Participants will receive treatment with escitalopram.
716680|NCT00183677|P1|Participant Flow|Open Label Escitalopram|Participants will receive treatment with escitalopram.
716681|NCT00183677|O1|Outcome|Open Label Escitalopram|Participants received open treatment with escitalopram.
716682|NCT00183677|E1|Reported Event|Open Label Escitalopram|Participants will receive treatment with escitalopram.
716683|NCT00183625|B3|Baseline|Total|Total of all reporting groups
716684|NCT00183625|B2|Baseline|Olanzapine Treatment|
716685|NCT00183625|B1|Baseline|Risperidone Treatment|
716686|NCT00183625|P4|Participant Flow|Olanzapine + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
716687|NCT00183625|P3|Participant Flow|Risperidone + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
716688|NCT00183625|P2|Participant Flow|Olanzapine Plus Supported Employment|Individual Placement and Support plus Olanzapine. Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
716689|NCT00183625|P1|Participant Flow|Risperidone Plus Supported Employment|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
716690|NCT00183625|O2|Outcome|Olanzapine Treatment|
716692|NCT00183625|O2|Outcome|Individual Placement and Support With Workplace Fundamentals|Olanzapine and Risperidone Patients included.
716693|NCT00183625|O1|Outcome|Individual Placement and Support (IPS)|IPS alone for risperidone and olanzapine subjects
716694|NCT00183625|E2|Reported Event|Olanzapine Treatment|
716695|NCT00183625|E1|Reported Event|Risperidone Treatment|
716696|NCT00183469|B3|Baseline|Total|Total of all reporting groups
716697|NCT00183469|B2|Baseline|Lamotrigine Plus Placebo Divalproex ER|
716698|NCT00183469|B1|Baseline|Lamotrigine Plus Divalproex ER|Enrolled subjects received lamotrigine and divalproex ER
716699|NCT00183469|P2|Participant Flow|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
716700|NCT00183469|P1|Participant Flow|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
716701|NCT00183469|O2|Outcome|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
716702|NCT00183469|O1|Outcome|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
716703|NCT00183469|E2|Reported Event|Lamotrigine Plus Placebo Divalproex ER|randomized subjects will take active lamotrigine and placebo divalproex ER
716704|NCT00183469|E1|Reported Event|Lamotrigine Plus Active Divalproex ER|randomized participants will take active lamotrigine and active divalproex Er
716705|NCT00183456|B5|Baseline|Total|Total of all reporting groups
716706|NCT00183456|B4|Baseline|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716707|NCT00183456|B3|Baseline|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716708|NCT00183456|B2|Baseline|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716709|NCT00183456|B1|Baseline|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716710|NCT00183456|P4|Participant Flow|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716711|NCT00183456|P3|Participant Flow|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716712|NCT00183456|P2|Participant Flow|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716713|NCT00183456|P1|Participant Flow|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716714|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716715|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716716|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716717|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716718|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716719|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716720|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716721|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716722|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716723|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716724|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716783|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
716725|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716726|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716727|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716728|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716729|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716730|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716731|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716732|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716733|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716734|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716735|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716736|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716737|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716738|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716739|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716740|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716741|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716742|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716743|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716744|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716745|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716746|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716747|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716748|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716749|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716784|NCT00183339|E2|Reported Event|Fluoxetine|participants who were treated with flexible dose fluoxetine solution, 2-20mg per day
716750|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716751|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716752|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716753|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716754|NCT00183456|E4|Reported Event|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
716755|NCT00183456|E3|Reported Event|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
716756|NCT00183456|E2|Reported Event|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
716757|NCT00183456|E1|Reported Event|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
716758|NCT00183430|B3|Baseline|Total|Total of all reporting groups
716759|NCT00183430|B2|Baseline|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716760|NCT00183430|B1|Baseline|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716761|NCT00183430|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716762|NCT00183430|P1|Participant Flow|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716763|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716764|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716765|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716766|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716767|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716768|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716769|NCT00183430|E2|Reported Event|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716770|NCT00183430|E1|Reported Event|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
716771|NCT00183339|B3|Baseline|Total|Total of all reporting groups
716772|NCT00183339|B2|Baseline|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
716773|NCT00183339|B1|Baseline|Placebo|Participants will take the placebo
716774|NCT00183339|P2|Participant Flow|Fluoxetine|Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule
716775|NCT00183339|P1|Participant Flow|Placebo|Participants who received placebo solution between .5ml and 5.0ml
716776|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
716777|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
716778|NCT00183339|O2|Outcome|Fluoxetine|participants who were treated with flexible dose (2-20mg/D) fluoxetine solution
716779|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
716780|NCT00183339|O2|Outcome|Fluoxetine|Participants treated with flexible dose fluoxetine solution
716781|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
716785|NCT00183339|E1|Reported Event|Placebo|participants who were treated with flexible dose placebo solution
716786|NCT00183274|B1|Baseline|Venlafaxine XR|"Venlafaxine XR flexible dose of 75 - 225 mg/d~Venlafaxine XR : All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine."
716787|NCT00183274|P6|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)|Patients administered placebo in Phase 2 continued to take placebo during Phase 3
716788|NCT00183274|P5|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Drug)|Patients administered venlafaxine XR in Phase 2 were given a placebo in Phase 3
716789|NCT00183274|P4|Participant Flow|Phase 3: Double-Blind Relapse Phase (Drug After Drug)|Patients administered venlafaxine XR in phase 2 continued to take the drug during phase 3
716790|NCT00183274|P3|Participant Flow|Phase 2: Double-Blind Placebo|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in a 60:40 ratio of drug to placebo
716791|NCT00183274|P2|Participant Flow|Phase 2: Double-Blind Venlafaxine XR|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in 60:40 ratio of drug to placebo
716792|NCT00183274|P1|Participant Flow|Phase 1: Open-Label|Patients received 75mg - 225 mg of open-label venlafaxine XR for 6 months.
716793|NCT00183274|O6|Outcome|Placebo After Placebo|after receiving drug in phases 1 and placebo in phase 2, patients received placebo in phase 3
716794|NCT00183274|O5|Outcome|Phase 3: Placebo After Drug|after receiving drug in phases 1 and 2, patients received placebo in phase 3
716795|NCT00183274|O4|Outcome|Phase 3: Double-Blind Drug After Drug|after receiving drug in phases 1 and 2, patients continued to receive drug in phase 3
716796|NCT00183274|O3|Outcome|Phase 2: Double-Blind Placebo|After receiving drug in Phase 1, patients began receiving placebo in phase 2
716797|NCT00183274|O2|Outcome|Phase 2: Double-Blind Venlafaxine XR|after receiving drug in phase 1, patients continued to receive drug in phase 2
716798|NCT00183274|O1|Outcome|Phase 1: Open-Label Venlafaxine XR|A 6-month administration of Venlafaxine XR that occurred between months 1 - 6 of study.
716799|NCT00183274|O6|Outcome|Double-Blind Placebo After Placebo|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
716800|NCT00183274|O5|Outcome|Double-Blind Relapse Placebo After Drug|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
716801|NCT00183274|O4|Outcome|Double-Blind Relapse Drug After Drug|A 6-month double-blind administration of Venlafaxine XR that occurred between months 13 - 18.
716802|NCT00183274|O3|Outcome|Double-Blind Placebo|A 6-month double-blind administration of placebo that occurred between months 7 - 12.
716803|NCT00183274|O2|Outcome|Double-Blind Venlafaxine XR|A 6-month double-blind administration of Venlafaxine XR that occurred between months 7 - 12.
716804|NCT00183274|O1|Outcome|Open-Label: Venlafaxine XR|A 6-month open label administration of flexible dose Venlafaxine XR that occurred between months 1 - 6 of study.
716805|NCT00183274|E1|Reported Event|Venlafaxine XR|Adverse events were expected with venlafaxine XR. AEs were reported at least once by at least 5% of the study population for all patients who entered treatment. None of the adverse events that were expected or that occurred were considered serious or life threatening.
716806|NCT00183248|B3|Baseline|Total|Total of all reporting groups
716807|NCT00183248|B2|Baseline|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
716808|NCT00183248|B1|Baseline|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
716809|NCT00183248|P2|Participant Flow|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
716810|NCT00183248|P1|Participant Flow|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
716811|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716812|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716813|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716836|NCT00183196|O1|Outcome|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
716837|NCT00183196|E3|Reported Event|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
716814|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716815|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716816|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716817|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716818|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716819|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716820|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716821|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716822|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716823|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716824|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
716825|NCT00183248|E2|Reported Event|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
716826|NCT00183248|E1|Reported Event|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
716827|NCT00183196|B4|Baseline|Total|Total of all reporting groups
716828|NCT00183196|B3|Baseline|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
716829|NCT00183196|B2|Baseline|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
716830|NCT00183196|B1|Baseline|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
716831|NCT00183196|P3|Participant Flow|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
716832|NCT00183196|P2|Participant Flow|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
716833|NCT00183196|P1|Participant Flow|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
716834|NCT00183196|O3|Outcome|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
716835|NCT00183196|O2|Outcome|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
716838|NCT00183196|E2|Reported Event|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
716839|NCT00183196|E1|Reported Event|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
716840|NCT00183092|B3|Baseline|Total|Total of all reporting groups
716841|NCT00183092|B2|Baseline|Quinacrine|Quinacrine : 100mg by mouth three times a day
716842|NCT00183092|B1|Baseline|Placebo|Placebo : 100mg by mouth three times a day
716843|NCT00183092|P4|Participant Flow|Study Drug (Placebo) During Open-Label Period|Participants received Placebo during Double-Blind period and opted to continue study drug during Open-Label period
716844|NCT00183092|P3|Participant Flow|Study Drug (Quinacrine) During Open-Label Period|Participants received Quinacrine during Double-Blind period and opted to continue study drug during Open-Label period
716845|NCT00183092|P2|Participant Flow|Placebo|Double Blind Period: 100mg Placebo by mouth three times a day. Open Label Period: Choice of study drug or Quinacrine 100mg by mouth three times a day.
716846|NCT00183092|P1|Participant Flow|Quinacrine|Double Blind Period: 100mg Quinacrine by mouth three times a day. Open Label Period: Choice of study drug or open-label Quinacrine 100mg by mouth three times a day.
716847|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716848|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716849|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716850|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716851|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716852|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716853|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716854|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716855|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716856|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716857|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716858|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716859|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716860|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716861|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
716862|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
716863|NCT00183092|E3|Reported Event|Quinacrine Open-label|Quinacrine: Month 2 until death = optional open-label Quinacrine 100mg by mouth three times a day
716864|NCT00183092|E2|Reported Event|Quinacrine Random Assignment|Quinacrine: 100mg by mouth three times a day. Baseline-Month 2 = random assignment (n=23), Month 2+ = optional continuation of assigned drug (n=1).
716865|NCT00183092|E1|Reported Event|Placebo Random Assignment|Placebo : 100mg by mouth three times a day, Baseline-Month 2 = random assignment (n=28), Month 2+ = optional continuation of assigned drug (n=1).
716866|NCT00182793|B1|Baseline|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
716867|NCT00182793|P1|Participant Flow|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
716868|NCT00182793|O1|Outcome|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
716869|NCT00182793|O1|Outcome|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
716898|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
716899|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
716900|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
716901|NCT00182754|E2|Reported Event|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
716870|NCT00182793|E1|Reported Event|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
716871|NCT00182767|B1|Baseline|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716872|NCT00182767|P5|Participant Flow|Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716873|NCT00182767|P4|Participant Flow|Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716874|NCT00182767|P3|Participant Flow|Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716875|NCT00182767|P2|Participant Flow|Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716876|NCT00182767|P1|Participant Flow|Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716877|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716878|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716879|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716880|NCT00182767|O5|Outcome|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716881|NCT00182767|O4|Outcome|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716882|NCT00182767|O3|Outcome|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716883|NCT00182767|O2|Outcome|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716884|NCT00182767|O1|Outcome|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716885|NCT00182767|E5|Reported Event|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716886|NCT00182767|E4|Reported Event|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716887|NCT00182767|E3|Reported Event|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716888|NCT00182767|E2|Reported Event|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716889|NCT00182767|E1|Reported Event|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
716890|NCT00182754|B3|Baseline|Total|Total of all reporting groups
716891|NCT00182754|B2|Baseline|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
716892|NCT00182754|B1|Baseline|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
716893|NCT00182754|P2|Participant Flow|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
716894|NCT00182754|P1|Participant Flow|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
716895|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
716896|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
716897|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
716902|NCT00182754|E1|Reported Event|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
716903|NCT00182728|B1|Baseline|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716904|NCT00182728|P1|Participant Flow|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716905|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716906|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716907|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716908|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716909|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716910|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716911|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716912|NCT00182728|E1|Reported Event|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
716913|NCT00182689|B3|Baseline|Total|Total of all reporting groups
716914|NCT00182689|B2|Baseline|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
716915|NCT00182689|B1|Baseline|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
716916|NCT00182689|P2|Participant Flow|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
716917|NCT00182689|P1|Participant Flow|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
716918|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
716919|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
716920|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
716921|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
716922|NCT00182689|O2|Outcome|Platinum Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
716923|NCT00182689|O1|Outcome|Platinum Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
716924|NCT00182689|E2|Reported Event|Platinum Refractory|
716925|NCT00182689|E1|Reported Event|Platinum Sensitive|
716926|NCT00182637|B1|Baseline|Bortezomib|administration of bortezomib
716927|NCT00182637|P1|Participant Flow|Bortezomib|administration of bortezomib
716928|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
716929|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
716930|NCT00182637|O1|Outcome|Bortezomib|bortezomib
716931|NCT00182637|E1|Reported Event|Bortezomib|administration of bortezomib
716932|NCT00182091|B5|Baseline|Total|Total of all reporting groups
716933|NCT00182091|B4|Baseline|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
716934|NCT00182091|B3|Baseline|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
716935|NCT00182091|B2|Baseline|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
716936|NCT00182091|B1|Baseline|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
716937|NCT00182091|P4|Participant Flow|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
716938|NCT00182091|P3|Participant Flow|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
716939|NCT00182091|P2|Participant Flow|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
716940|NCT00182091|P1|Participant Flow|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
716941|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
716942|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
716943|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
716944|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
716945|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
716946|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
716947|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
716948|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
716949|NCT00182091|E4|Reported Event|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
716950|NCT00182091|E3|Reported Event|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
716951|NCT00182091|E2|Reported Event|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
716952|NCT00182091|E1|Reported Event|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
716953|NCT00182078|B3|Baseline|Total|Total of all reporting groups
716954|NCT00182078|B2|Baseline|Sertraline|Sertraline group received study medication every day for 12 weeks.
716955|NCT00182078|B1|Baseline|Placebo|Placebo group who received no study medication.
716956|NCT00182078|P2|Participant Flow|Sertraline - Received Study Medication|The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
716957|NCT00182078|P1|Participant Flow|Placebo - Received Placebo|The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
716958|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
716959|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
716960|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
716961|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
716962|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
716963|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
716964|NCT00182078|E2|Reported Event|Sertraline|Sertraline group received study medication every day for 12 weeks.
716965|NCT00182078|E1|Reported Event|Placebo|Placebo group who received no study medication.
716966|NCT00182000|B3|Baseline|Total|Total of all reporting groups
716967|NCT00182000|B2|Baseline|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
716968|NCT00182000|B1|Baseline|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
716969|NCT00182000|P2|Participant Flow|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
716970|NCT00182000|P1|Participant Flow|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
716971|NCT00182000|O2|Outcome|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
716972|NCT00182000|O1|Outcome|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
716973|NCT00182000|E2|Reported Event|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
716974|NCT00182000|E1|Reported Event|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
716975|NCT00181883|B1|Baseline|Quetiapine|
716976|NCT00181883|P1|Participant Flow|Quetiapine|
716977|NCT00181883|O1|Outcome|Quetiapine|
716978|NCT00181883|E1|Reported Event|Quetiapine|
716979|NCT00181844|B1|Baseline|Lamotrigine|
716980|NCT00181844|P1|Participant Flow|Lamotrigine|
716981|NCT00181844|O1|Outcome|Lamotrigine|
716982|NCT00181844|E1|Reported Event|Lamotrigine|
716983|NCT00181766|B1|Baseline|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
716984|NCT00181766|P1|Participant Flow|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
716985|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
716986|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
716987|NCT00181766|E1|Reported Event|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
716988|NCT00181714|B1|Baseline|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
716989|NCT00181714|P1|Participant Flow|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
716990|NCT00181714|O1|Outcome|OROS-Methylphenidate|
716991|NCT00181714|E1|Reported Event|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
717113|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
716992|NCT00181623|B1|Baseline|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
716993|NCT00181623|P1|Participant Flow|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin 60 mcg/kg~Recombinant Human Prolactin :"
716994|NCT00181623|O1|Outcome|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin 60 mcg/kg~Recombinant Human Prolactin :"
716995|NCT00181623|O1|Outcome|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
716996|NCT00181623|E1|Reported Event|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
716997|NCT00181610|B4|Baseline|Total|Total of all reporting groups
716998|NCT00181610|B3|Baseline|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
716999|NCT00181610|B2|Baseline|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
717000|NCT00181610|B1|Baseline|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
717001|NCT00181610|P3|Participant Flow|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours"
717002|NCT00181610|P2|Participant Flow|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
717003|NCT00181610|P1|Participant Flow|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
717004|NCT00181610|O3|Outcome|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours"
717005|NCT00181610|O2|Outcome|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
717006|NCT00181610|O1|Outcome|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
717007|NCT00181610|O3|Outcome|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours Placebo given every 24 hours"
717008|NCT00181610|O2|Outcome|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
717009|NCT00181610|O1|Outcome|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
717010|NCT00181610|E3|Reported Event|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
717011|NCT00181610|E2|Reported Event|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
717012|NCT00181610|E1|Reported Event|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
717013|NCT00181155|B1|Baseline|Intravenous Allopurinol|We randomized patients with nonischemic cardiomyopathy in a double-blind fashion to allopurinol (300 mg intravenously) or placebo infusion, 4-to-1, the latter for purposes of blinding only. The myocardial concentrations of ATP and creatine phosphate (PCr) and the rate of adenosine triphosphate (ATP) synthesis through CK (CK flux) were determined by 31-Phosphorus (31P) magnetic resonance spectroscopy.
717014|NCT00181155|P2|Participant Flow|Placebo|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
717015|NCT00181155|P1|Participant Flow|Allopurinol|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
717016|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc of 5% dextrose. Post infusion MRS data acquired on each subject.
717017|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc 5% dextrose. Post MRS data acquired on each subject.
717018|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
717019|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
717020|NCT00181155|E2|Reported Event|Arm 2 - Placebo|Each participant received pre and post MRS images following infusion of 50 cc of 5% Dextrose (equivalent volume to active treatment arm).
717021|NCT00181155|E1|Reported Event|Arm 1 - Intravenous Allopurinol|Each participant received pre and post MRS images following infusion of 50 cc of Aloprim 300mg in 5% Dextrose.
717022|NCT00180687|B5|Baseline|Total|Total of all reporting groups
717023|NCT00180687|B4|Baseline|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
717024|NCT00180687|B3|Baseline|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
717025|NCT00180687|B2|Baseline|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
717026|NCT00180687|B1|Baseline|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
717027|NCT00180687|P4|Participant Flow|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
717028|NCT00180687|P3|Participant Flow|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
717029|NCT00180687|P2|Participant Flow|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
717030|NCT00180687|P1|Participant Flow|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
717031|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
717032|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
717033|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
717034|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
717035|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
717036|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
717037|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
717038|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
717039|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
717040|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
717041|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
717042|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
717043|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
717044|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
717045|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
717046|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
717047|NCT00180687|E4|Reported Event|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
717048|NCT00180687|E3|Reported Event|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
717049|NCT00180687|E2|Reported Event|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
717050|NCT00180687|E1|Reported Event|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
717051|NCT00180479|B3|Baseline|Total|Total of all reporting groups
717052|NCT00180479|B2|Baseline|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717053|NCT00180479|B1|Baseline|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717054|NCT00180479|P2|Participant Flow|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717055|NCT00180479|P1|Participant Flow|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717056|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717057|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717058|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717059|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717060|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717061|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717062|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717063|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717064|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717065|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717066|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717067|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717068|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717069|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717070|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717071|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717072|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717073|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717074|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717075|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717076|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717077|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717078|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717079|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717080|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717081|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717082|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717083|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717084|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717085|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717086|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717087|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717088|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717089|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717090|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717091|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717092|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717093|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717094|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717095|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717096|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717097|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717098|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717099|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717100|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717101|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717102|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717103|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717104|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717105|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717106|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717107|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717108|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717109|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717110|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717111|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717112|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717114|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717115|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717116|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717117|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717118|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717119|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717120|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717121|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717122|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717123|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717124|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717125|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717126|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717127|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717128|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717129|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717130|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717131|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717132|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717133|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717134|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717135|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717136|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717137|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717138|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717139|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717140|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717141|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717142|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717143|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717144|NCT00180479|E2|Reported Event|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
717145|NCT00180479|E1|Reported Event|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
717146|NCT00180323|B1|Baseline|Group 1|
717147|NCT00180323|P1|Participant Flow|Group 1|
717148|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
717149|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|6 minute walktest (6 MWT) was performed before implant (baseline ), 3months and 6 months Follow-up.
717150|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
717151|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
717152|NCT00180323|E1|Reported Event|Group 1|
717153|NCT00180271|B3|Baseline|Total|Total of all reporting groups
717154|NCT00180271|B2|Baseline|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
717225|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717226|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717155|NCT00180271|B1|Baseline|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
717156|NCT00180271|P2|Participant Flow|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
717157|NCT00180271|P1|Participant Flow|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
717158|NCT00180271|O2|Outcome|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
717159|NCT00180271|O1|Outcome|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
717160|NCT00180271|E2|Reported Event|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
717161|NCT00180271|E1|Reported Event|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
717162|NCT00179959|B3|Baseline|Total|Total of all reporting groups
717163|NCT00179959|B2|Baseline|Placebo|Intranasal petrolatum ointment treatment and plain water baths
717164|NCT00179959|B1|Baseline|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
717165|NCT00179959|P2|Participant Flow|Placebo|Intranasal petrolatum ointment treatment and plain water baths
717166|NCT00179959|P1|Participant Flow|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
717167|NCT00179959|O2|Outcome|Placebo|Intranasal petrolatum ointment treatment and plain water baths
717168|NCT00179959|O1|Outcome|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
717169|NCT00179959|E2|Reported Event|Placebo|Intranasal petrolatum ointment treatment and plain water baths
717170|NCT00179959|E1|Reported Event|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
717171|NCT00179673|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717172|NCT00179673|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717173|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717174|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717175|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717176|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717177|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717178|NCT00179673|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717179|NCT00179660|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717180|NCT00179660|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717181|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717182|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717183|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717184|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717185|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717186|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717187|NCT00179660|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
717188|NCT00179647|B1|Baseline|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
717189|NCT00179647|P1|Participant Flow|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
717190|NCT00179647|O1|Outcome|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
717191|NCT00179647|E1|Reported Event|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
717192|NCT00179621|B4|Baseline|Total|Total of all reporting groups
717193|NCT00179621|B3|Baseline|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717194|NCT00179621|B2|Baseline|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717195|NCT00179621|B1|Baseline|Placebo|Placebo matching to active study arms.
717196|NCT00179621|P4|Participant Flow|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
717197|NCT00179621|P3|Participant Flow|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717198|NCT00179621|P2|Participant Flow|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717199|NCT00179621|P1|Participant Flow|Placebo|Placebo matching to active study arms.
717200|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717201|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717202|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717203|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717204|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717205|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717206|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717207|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717208|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717209|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717210|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717211|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717212|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717213|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717214|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717215|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717216|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717217|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717218|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717219|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717220|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717221|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717222|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717223|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717224|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717227|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717228|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717229|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717230|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717231|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717232|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717233|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717234|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717235|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717236|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717237|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717238|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717239|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717240|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717241|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717242|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717243|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717244|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
717245|NCT00179621|E4|Reported Event|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
717246|NCT00179621|E3|Reported Event|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
717247|NCT00179621|E2|Reported Event|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
717248|NCT00179621|E1|Reported Event|Placebo|Placebo matching to active study arms.
717249|NCT00179517|B3|Baseline|Total|Total of all reporting groups
717250|NCT00179517|B2|Baseline|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717251|NCT00179517|B1|Baseline|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717252|NCT00179517|P2|Participant Flow|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717253|NCT00179517|P1|Participant Flow|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717254|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717255|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717256|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717257|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717258|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717259|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717260|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717261|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717262|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717263|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717264|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717265|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717266|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717267|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717268|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717269|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717270|NCT00179517|O2|Outcome|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717271|NCT00179517|O1|Outcome|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717272|NCT00179517|E2|Reported Event|Depotestosterone Plus Placebo (T–P)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.~Placebo Oral Tablet"
717273|NCT00179517|E1|Reported Event|Depotestosterone Plus Anastrozole (T–A)|"Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.~Anastrozole 1mg"
717274|NCT00179478|B3|Baseline|Total|Total of all reporting groups
717275|NCT00179478|B2|Baseline|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717276|NCT00179478|B1|Baseline|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717277|NCT00179478|P2|Participant Flow|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717278|NCT00179478|P1|Participant Flow|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717279|NCT00179478|O2|Outcome|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717280|NCT00179478|O1|Outcome|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717281|NCT00179478|O2|Outcome|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717282|NCT00179478|O1|Outcome|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717283|NCT00179478|O2|Outcome|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
719156|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
717284|NCT00179478|O1|Outcome|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717285|NCT00179478|O2|Outcome|Delayed Treatment Group|"Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717286|NCT00179478|O1|Outcome|Immediate Treatment Group|"Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals~interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date."
717287|NCT00179478|E1|Reported Event|All Study Participants|All patients in the study were receiving the same FDA approved treatment, interferon beta 1a IM once weekly (AVONEX), which they received commercially through their insurance coverage. No AEs were collected and any serious AEs that occurred, would have been reported to the manufacturer (Biogen). We collected information on all cause mortality on the cohort of 155 patients who continued in the 10 year extension study. This was done as an additional outcome measure since we anticipated that there may be deaths due to the primary disease (MS) over a period of observation as long as 10 years.
717288|NCT00179413|B3|Baseline|Total|Total of all reporting groups
717289|NCT00179413|B2|Baseline|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
717290|NCT00179413|B1|Baseline|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
717291|NCT00179413|P2|Participant Flow|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
717292|NCT00179413|P1|Participant Flow|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
717293|NCT00179413|O2|Outcome|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
717294|NCT00179413|O1|Outcome|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
717295|NCT00179413|O2|Outcome|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
717296|NCT00179413|O1|Outcome|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
717297|NCT00179413|O2|Outcome|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
717298|NCT00179413|O1|Outcome|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
717299|NCT00179413|E2|Reported Event|Colchicine|"0.6mg twice a day~Colchicine: 0.6mg twice a day"
717300|NCT00179413|E1|Reported Event|PEG-Intron|"PEG-Intron 0.5mcg/kg once a week SC~PEG -Intron"
717301|NCT00179309|B3|Baseline|Total|Total of all reporting groups
717302|NCT00179309|B2|Baseline|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
717303|NCT00179309|B1|Baseline|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
717304|NCT00179309|P2|Participant Flow|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
717305|NCT00179309|P1|Participant Flow|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V: given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
717325|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
717306|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
717307|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
717308|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
717309|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
717310|NCT00179309|E2|Reported Event|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
717311|NCT00179309|E1|Reported Event|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
717312|NCT00178919|B3|Baseline|Total|Total of all reporting groups
717313|NCT00178919|B2|Baseline|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
717314|NCT00178919|B1|Baseline|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
717315|NCT00178919|P2|Participant Flow|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
717316|NCT00178919|P1|Participant Flow|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
717317|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
717318|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
717319|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
717320|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
717321|NCT00178919|E2|Reported Event|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
717322|NCT00178919|E1|Reported Event|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
717323|NCT00178841|B1|Baseline|Single Arm Study|All enrolled patients received rosiglitazone in addition to oral bexarotene
717324|NCT00178841|P1|Participant Flow|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
719157|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
717326|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
717327|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
717328|NCT00178841|E1|Reported Event|Rosiglitazone and Bexarotene|All enrolled patients received rosiglitazone in addition to oral bexarotene.
717329|NCT00178711|B3|Baseline|Total|Total of all reporting groups
717330|NCT00178711|B2|Baseline|Control|Treated at normothermia
717331|NCT00178711|B1|Baseline|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
717332|NCT00178711|P2|Participant Flow|Control|45 patients who had none of the second set of exclusion criteria and who has been randomized to normothermia served as the control group
717333|NCT00178711|P1|Participant Flow|Hypothermia|"There were two sets of exclusion criteria-one in the field; the other after resuscitation in the ER. In the field, patients were excluded for suspected pregnancy, systolic blood pressure <110 mm Hg, diastolic blood pressure <60 mm Hg, sustained heart rate >120 beats per minute, or failure to be reached by study-affiliated personnel within 2.5 hours of injury.~Those that did not have any of the first set of exclusion criteria were further assessed for the presence of Glasgow Coma Scale 3-8 without life-threatening associated injuries. The second set of exclusion criteria were GCS 3 with nonreactive pupils, GCS 7-8 with normal brain CT scan, inability to obtain an accurate GCS, Abbreviated Injury Severity Score >4 for organs other than brain4, systolic blood pressure <110 mm Hg or diastolic blood pressure <60 mm Hg, persistent hypoxia, (oxygen saturation < 94%), or positive pregnancy test."
717334|NCT00178711|O2|Outcome|Control|treated at normothermia
717335|NCT00178711|O1|Outcome|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
717336|NCT00178711|E4|Reported Event|Randomized to Normothermia Then Excluded|Maintenance of normothermia before trauma evaluation in ED and then excluded by second set of criteria
717337|NCT00178711|E3|Reported Event|Randomized to Hypothermia and Then Excluded|Induction and maintenance of moderate hypothermia before trauma evaluation in ED and then excluded by second set of criteria
717338|NCT00178711|E2|Reported Event|Randomized to Normothermia and Normothermia Maintained|Induction and maintenance of normothermia and not excluded by second set of exclusion criteria
717339|NCT00178711|E1|Reported Event|Randomized to Hypothermia and Hypothermia Maintained|Induction and maintenance of moderate hypothermia and not excluded by second set of exclusion criteria
717340|NCT00178685|B4|Baseline|Total|Total of all reporting groups
717341|NCT00178685|B3|Baseline|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
717342|NCT00178685|B2|Baseline|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
717343|NCT00178685|B1|Baseline|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
717344|NCT00178685|P3|Participant Flow|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
717345|NCT00178685|P2|Participant Flow|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
717346|NCT00178685|P1|Participant Flow|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
717347|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
717926|NCT00174941|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717348|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
717349|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
717350|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
717351|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
717352|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
717353|NCT00178685|E3|Reported Event|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
717354|NCT00178685|E2|Reported Event|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
717355|NCT00178685|E1|Reported Event|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
717356|NCT00178633|B1|Baseline|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
717357|NCT00178633|P1|Participant Flow|Bariatric Surgery|
717358|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
717359|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
717360|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
717361|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
717362|NCT00178633|E2|Reported Event|Bariatric Surgery, Follow up at 2 Years|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
717363|NCT00178633|E1|Reported Event|Bariatric Surgery, Follow up at 9 Months|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
717364|NCT00178503|B1|Baseline|MPH Trial|24 Participants with ASD-ADHD underwent 1 week of placebo, 1 week of Low dose, 1 week of Medium dose, and 1 week of High dose in the MPH treatment phase
717365|NCT00178503|P1|Participant Flow|MPH Trial|24 participants with autism spectrum disorder and ADHD underwent a randomized, placebo-controlled, cross-over designed trial, which included: 1 week of placebo, 1 week of low dose methylphenidate, 1 week of medium dose methylphenidate, 1 week of high dose methylphenidate.
717366|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717367|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717368|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717369|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
717370|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717371|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717372|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717373|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
717374|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
717375|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717376|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717377|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
717378|NCT00178503|E4|Reported Event|MPH Trial: High Dose|Participants with ASD-ADHD who will undergo 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717379|NCT00178503|E3|Reported Event|MPH Trial: Med Dose|Participants with ASD-ADHD who will undergo 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717380|NCT00178503|E2|Reported Event|MPH Trial: Low Dose|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
717381|NCT00178503|E1|Reported Event|MPH Trial-Placebo|Participants with ASD-ADHD who will undergo 1 week of placebo in the MPH treatment phase
717382|NCT00178477|B1|Baseline|Group 1|MRI with Breath Hold
717383|NCT00178477|P1|Participant Flow|Breath Hold|MRI with Breath Hold
717384|NCT00178477|O1|Outcome|Group 1|MRI with Breath Hold
717385|NCT00178477|E1|Reported Event|Group 1|MRI with Breath Hold
717386|NCT00178464|B1|Baseline|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
717387|NCT00178464|P1|Participant Flow|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
717388|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
717389|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
717390|NCT00178464|E1|Reported Event|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
717391|NCT00178256|B1|Baseline|Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
717392|NCT00178256|P4|Participant Flow|Phase II Group (20mg/m2 Taxol)|"Once the MTD has been determined and confirmed with a total of six patients, up to 19 additional patients with measurable disease will be enrolled at that dose in order to obtain estimates of response rate and more information about toxicity Phase II enrollment will be in two stages. Initially 9 or 12 patients (depending on how many were tested at the MTD dose in the Phase I study) will be tested, for a total of 15 patients at the MTD. If fewer than 4 responses are observed, the study will end with 90% confidence that the true response rate is no greater than 40%, which is the minimum clinically interesting response rate.~If four or more responses are observed, additional patients will be enrolled to obtain 25 evaluable patients at the MTD. This will allow estimation of the true response rate and toxicity rates with standard errors of no more than 0.1."
717393|NCT00178256|P3|Participant Flow|Third Dose Cohort (25mg/m2 Taxol) MWF and Daily RT|"A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
717422|NCT00178178|P1|Participant Flow|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717423|NCT00178178|O4|Outcome|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717927|NCT00174941|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717394|NCT00178256|P2|Participant Flow|Second Dose Cohort (20mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
717395|NCT00178256|P1|Participant Flow|First Dose Cohort (15mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
717396|NCT00178256|O1|Outcome|All Pts Enrolled Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
717397|NCT00178256|O3|Outcome|3rd Dose Cohort --25mg/m2 Taxol Plus RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
717398|NCT00178256|O2|Outcome|2nd Dose cohort20 mg/m2 Taxol Plus Daily RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
717399|NCT00178256|O1|Outcome|1st Dose Cohort 15mg/m2 Taxol Plus RT|"15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
717400|NCT00178256|E1|Reported Event|All Subjects Enrolled|
717401|NCT00178191|B4|Baseline|Total|Total of all reporting groups
717402|NCT00178191|B3|Baseline|Placebo|Placebo
717403|NCT00178191|B2|Baseline|300 Units Botox|300 units Botulinum-A toxin
717404|NCT00178191|B1|Baseline|200 Units Botox|200 units Botulinum-A toxin
717405|NCT00178191|P3|Participant Flow|Placebo|Placebo
717406|NCT00178191|P2|Participant Flow|300 Units Botox|300 units Botulinum-A toxin
717407|NCT00178191|P1|Participant Flow|200 Units Botox|200 units Botulinum-A toxin
717408|NCT00178191|O3|Outcome|Placebo|Placebo
717409|NCT00178191|O2|Outcome|300 Units Botox|300 units Botulinum-A toxin
717410|NCT00178191|O1|Outcome|200 Units Botox|200 units Botulinum-A toxin
717411|NCT00178191|E3|Reported Event|Placebo|Placebo
717412|NCT00178191|E2|Reported Event|300 Units Botox|300 units Botulinum-A toxin
717413|NCT00178191|E1|Reported Event|200 Units Botox|200 units Botulinum-A toxin
717414|NCT00178178|B5|Baseline|Total|Total of all reporting groups
717415|NCT00178178|B4|Baseline|Placebo Comparator|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717416|NCT00178178|B3|Baseline|Drug: Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717417|NCT00178178|B2|Baseline|Drug: Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717418|NCT00178178|B1|Baseline|Drug: Intraarticularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717419|NCT00178178|P4|Participant Flow|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717420|NCT00178178|P3|Participant Flow|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717421|NCT00178178|P2|Participant Flow|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717464|NCT00177866|B2|Baseline|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
719158|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
717424|NCT00178178|O3|Outcome|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717425|NCT00178178|O2|Outcome|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717426|NCT00178178|O1|Outcome|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717427|NCT00178178|E4|Reported Event|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717428|NCT00178178|E3|Reported Event|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717429|NCT00178178|E2|Reported Event|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717430|NCT00178178|E1|Reported Event|Intraartciularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
717431|NCT00178126|B3|Baseline|Total|Total of all reporting groups
717432|NCT00178126|B2|Baseline|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
717433|NCT00178126|B1|Baseline|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
717434|NCT00178126|P2|Participant Flow|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
717435|NCT00178126|P1|Participant Flow|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
717436|NCT00178126|O2|Outcome|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
717437|NCT00178126|O1|Outcome|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
717438|NCT00178126|E2|Reported Event|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
717439|NCT00178126|E1|Reported Event|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
717440|NCT00177970|B3|Baseline|Total|Total of all reporting groups
717441|NCT00177970|B2|Baseline|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717442|NCT00177970|B1|Baseline|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717443|NCT00177970|P2|Participant Flow|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717444|NCT00177970|P1|Participant Flow|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717445|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717446|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717447|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717448|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717449|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717450|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717451|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717452|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717453|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717454|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717455|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717456|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717457|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717458|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717459|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717460|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717461|NCT00177970|E2|Reported Event|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
717462|NCT00177970|E1|Reported Event|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
717463|NCT00177866|B3|Baseline|Total|Total of all reporting groups
717465|NCT00177866|B1|Baseline|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
717466|NCT00177866|P2|Participant Flow|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
717467|NCT00177866|P1|Participant Flow|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
717468|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
717469|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
717470|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
717471|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
717472|NCT00177866|E2|Reported Event|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
717473|NCT00177866|E1|Reported Event|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
717474|NCT00177671|B3|Baseline|Total|Total of all reporting groups
717475|NCT00177671|B2|Baseline|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
717476|NCT00177671|B1|Baseline|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
717477|NCT00177671|P2|Participant Flow|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
717478|NCT00177671|P1|Participant Flow|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
717479|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
717480|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
717481|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
717482|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
717483|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
717484|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
717485|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
717486|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
717487|NCT00177671|E2|Reported Event|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
717488|NCT00177671|E1|Reported Event|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
717489|NCT00177307|B1|Baseline|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
717490|NCT00177307|P1|Participant Flow|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
717528|NCT00177216|E1|Reported Event|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
717529|NCT00177164|B3|Baseline|Total|Total of all reporting groups
717928|NCT00174941|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717929|NCT00174941|O4|Outcome|Total Febuxostat|
717491|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
717492|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
717493|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
717494|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
717495|NCT00177307|E1|Reported Event|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
717496|NCT00177294|B3|Baseline|Total|Total of all reporting groups
717497|NCT00177294|B2|Baseline|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
717498|NCT00177294|B1|Baseline|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
717499|NCT00177294|P2|Participant Flow|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
717500|NCT00177294|P1|Participant Flow|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
717501|NCT00177294|O2|Outcome|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
717502|NCT00177294|O1|Outcome|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
717503|NCT00177294|E2|Reported Event|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
717504|NCT00177294|E1|Reported Event|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
717505|NCT00177255|B1|Baseline|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
717930|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717506|NCT00177255|P1|Participant Flow|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
717507|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
717508|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
717509|NCT00177255|E1|Reported Event|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
717510|NCT00177216|B4|Baseline|Total|Total of all reporting groups
717511|NCT00177216|B3|Baseline|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
717512|NCT00177216|B2|Baseline|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
717513|NCT00177216|B1|Baseline|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
717514|NCT00177216|P3|Participant Flow|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
717515|NCT00177216|P2|Participant Flow|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
717516|NCT00177216|P1|Participant Flow|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
717517|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
717518|NCT00177216|O2|Outcome|Escitalopram|Participants receiving an antidepressant, escitalopram
717519|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
717520|NCT00177216|O3|Outcome|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
717521|NCT00177216|O2|Outcome|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
717522|NCT00177216|O1|Outcome|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
717523|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
717524|NCT00177216|O2|Outcome|Escitalpram|Participants receiving an antidepressant, escitalopram
717525|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
717526|NCT00177216|E3|Reported Event|Placebo|Participants receiving a placebo
717527|NCT00177216|E2|Reported Event|Escitalopram|Participants receiving an antidepressant, escitalopram
717530|NCT00177164|B2|Baseline|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
717531|NCT00177164|B1|Baseline|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
717532|NCT00177164|P2|Participant Flow|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
717533|NCT00177164|P1|Participant Flow|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
717534|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
717535|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
717536|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
717537|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
717538|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
717539|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
717540|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
717541|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
717542|NCT00177164|E2|Reported Event|Oral AAP|
717543|NCT00177164|E1|Reported Event|Risperidone LAI|
717544|NCT00176917|B1|Baseline|Transplant Patients|Patients that received hematopoietic stem cell transplant.
717545|NCT00176917|P1|Participant Flow|Transplant Patients|Patients that received hematopoietic stem cell transplant.
717546|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
717547|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
717548|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
717549|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
717550|NCT00176917|E1|Reported Event|Transplant Patients|Patients that received hematopoietic stem cell transplant.
717551|NCT00176904|B1|Baseline|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717552|NCT00176904|P1|Participant Flow|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717553|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717554|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717555|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717556|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717557|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717558|NCT00176904|E1|Reported Event|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
717559|NCT00176878|B1|Baseline|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717560|NCT00176878|P1|Participant Flow|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717561|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717562|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717563|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717564|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717565|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717566|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717567|NCT00176878|E1|Reported Event|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
717568|NCT00176865|B4|Baseline|Total|Total of all reporting groups
717569|NCT00176865|B3|Baseline|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717570|NCT00176865|B2|Baseline|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717571|NCT00176865|B1|Baseline|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717572|NCT00176865|P3|Participant Flow|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717573|NCT00176865|P2|Participant Flow|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717574|NCT00176865|P1|Participant Flow|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717575|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717576|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717577|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717578|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717579|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717580|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717581|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717582|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717583|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717584|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717585|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717586|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717587|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717588|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717589|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717590|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717591|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717592|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717593|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717594|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717595|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717596|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717597|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717598|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717599|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717600|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717601|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717602|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717603|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717604|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717605|NCT00176865|E3|Reported Event|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717606|NCT00176865|E2|Reported Event|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717607|NCT00176865|E1|Reported Event|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
717608|NCT00176852|B4|Baseline|Total|Total of all reporting groups
717931|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717609|NCT00176852|B3|Baseline|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717610|NCT00176852|B2|Baseline|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717611|NCT00176852|B1|Baseline|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717612|NCT00176852|P3|Participant Flow|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717613|NCT00176852|P2|Participant Flow|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717614|NCT00176852|P1|Participant Flow|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717615|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717616|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717617|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717618|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717619|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717620|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717735|NCT00176462|E2|Reported Event|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
719159|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
717621|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717622|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717623|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717624|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717625|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717626|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717627|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717628|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717629|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717630|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717631|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717632|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717736|NCT00176462|E1|Reported Event|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
717737|NCT00176436|B3|Baseline|Total|Total of all reporting groups
717738|NCT00176436|B2|Baseline|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
717633|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717634|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717635|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717636|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717637|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717638|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717639|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717640|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717641|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717642|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717643|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717644|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717739|NCT00176436|B1|Baseline|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
717740|NCT00176436|P2|Participant Flow|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
719160|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
717645|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717646|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717647|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717648|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717649|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717650|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717651|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717652|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717653|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717654|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717655|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717656|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717741|NCT00176436|P1|Participant Flow|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
717742|NCT00176436|O2|Outcome|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
717743|NCT00176436|O1|Outcome|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
717657|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717658|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717659|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717660|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717661|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717662|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717663|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717664|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717665|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717666|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717667|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717668|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717744|NCT00176436|E2|Reported Event|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
717745|NCT00176436|E1|Reported Event|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
717746|NCT00176306|B1|Baseline|Levofloxacin Arm|patients receiving levofloxacin
717669|NCT00176852|E3|Reported Event|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717670|NCT00176852|E2|Reported Event|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
717671|NCT00176852|E1|Reported Event|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
717672|NCT00176839|B1|Baseline|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717673|NCT00176839|P1|Participant Flow|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717674|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717675|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717676|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717677|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717678|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717679|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717680|NCT00176839|E1|Reported Event|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
717681|NCT00176826|B1|Baseline|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717682|NCT00176826|P1|Participant Flow|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717683|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717684|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717685|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717686|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717687|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717688|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717689|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717690|NCT00176826|E1|Reported Event|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
717747|NCT00176306|P1|Participant Flow|Levofloxacin Arm|Patients receive commercially available levofloxacin 750mg solution for intravnous use
717748|NCT00176306|O1|Outcome|Levofloxacin Arm|Subjects receiving levofloxacin
717749|NCT00176306|E1|Reported Event|Levofloxacin Arm|patients receiving levofloxacin
717691|NCT00176800|B1|Baseline|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
717692|NCT00176800|P1|Participant Flow|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
717693|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
717694|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
717695|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
717696|NCT00176800|E1|Reported Event|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
717697|NCT00176644|B1|Baseline|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717698|NCT00176644|P1|Participant Flow|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717699|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717700|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717701|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717750|NCT00176254|B1|Baseline|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717932|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717933|NCT00174941|O4|Outcome|Total Febuxostat|
717702|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717703|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717704|NCT00176644|E1|Reported Event|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
717705|NCT00176631|B1|Baseline|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
717706|NCT00176631|P1|Participant Flow|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
717707|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
717708|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
717709|NCT00176631|E1|Reported Event|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
717710|NCT00176605|B1|Baseline|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
717711|NCT00176605|P1|Participant Flow|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
717712|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
717713|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
717714|NCT00176605|E1|Reported Event|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
717715|NCT00176501|B1|Baseline|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
717716|NCT00176501|P1|Participant Flow|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
717717|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
717718|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
717719|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
717720|NCT00176501|E1|Reported Event|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
717721|NCT00176488|B1|Baseline|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
717722|NCT00176488|P1|Participant Flow|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.~Beginning on cycle 1, patients will receive G-CSF (Neupogen) at a dose of 5 mcg/kg on Day 4 of treatment for 10 days OR pegfilgrastim (Neulasta) 6 mg on Day 4 of treatment."
717723|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
717724|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
717725|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
717726|NCT00176488|E1|Reported Event|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
717727|NCT00176462|B3|Baseline|Total|Total of all reporting groups
717728|NCT00176462|B2|Baseline|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
717729|NCT00176462|B1|Baseline|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
717730|NCT00176462|P2|Participant Flow|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
717731|NCT00176462|P1|Participant Flow|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
717732|NCT00176462|O2|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
717733|NCT00176462|O1|Outcome|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
717734|NCT00176462|O1|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
717751|NCT00176254|P1|Participant Flow|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m^2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717752|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717753|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717754|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717755|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717756|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717757|NCT00176254|E1|Reported Event|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
717758|NCT00176228|B1|Baseline|Lamotrigine|upto 200 mg
717759|NCT00176228|P1|Participant Flow|Lamotrigine|upto 200 mg
717760|NCT00176228|O1|Outcome|Lamotrigine|Lamotrigine: Response on CDRS-R
717761|NCT00176228|O1|Outcome|Lamotrigine Effectiveness on YMRS (Mania Measure)|
717762|NCT00176228|E1|Reported Event|Lamotrigine|upto 200 mg
717763|NCT00176202|B3|Baseline|Total|Total of all reporting groups
717764|NCT00176202|B2|Baseline|Divalproex|Divalproex sodium, also referred to as divalproex is an antiepileptic medication used for mania and is referred to as mood stabilizer. Its trade name is Depakote.
717765|NCT00176202|B1|Baseline|Risperidone|"Risperidone is an antipsychotic medication and is used to treat mania. Its trade name is Risperdal.~Aim of the study is to cross compare the relative efficacy and safety of risperidone and divalproex sodium in treating/stabilizing mania in pediatric bipolar disorder."
717766|NCT00176202|P2|Participant Flow|Divalproex Sodium|This is antiepileptic medication and is a comparator drug to see if it is as efficacious as risperidone assumption is both have equal efficacy with no difference between the two.
717767|NCT00176202|P1|Participant Flow|Risperidone|The study aimed to compare the antipsychotic medication i.e., risperidone's efficacy with that of divalproex sodium (which is an antiepileptic medication) in treating/stabilizing pediatric bipolar disorder.
717768|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
717769|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
717770|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
717771|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
717772|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
717773|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
717774|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
717775|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
717776|NCT00176202|E2|Reported Event|Depakote or Divalproex Sodium|"Likely side effects include gastrointestinal side effects such as stomach discomfort, weight gain, agitation and sedation, fatigue or tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
717777|NCT00176202|E1|Reported Event|Risperidone|"Likely side effects include weight gain, muscle stiffness, sedation and tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
717778|NCT00175877|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717779|NCT00175877|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717780|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717781|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717782|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717783|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717784|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717785|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717786|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717787|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717788|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717789|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717790|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717791|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717792|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717858|NCT00175006|B1|Baseline|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
717934|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717793|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717794|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717795|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717796|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717797|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717798|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717799|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717800|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717801|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717802|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717803|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717804|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717805|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717859|NCT00175006|P1|Participant Flow|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
717935|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717806|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717807|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717808|NCT00175877|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
717809|NCT00175019|B4|Baseline|Total|Total of all reporting groups
717810|NCT00175019|B3|Baseline|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717811|NCT00175019|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717812|NCT00175019|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717813|NCT00175019|P3|Participant Flow|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717814|NCT00175019|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717815|NCT00175019|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717816|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717817|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717818|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717819|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717820|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717821|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717822|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717823|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717824|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717825|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717826|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717827|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717828|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717829|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717830|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717831|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717832|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717833|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717834|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717835|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717836|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717837|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717838|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717839|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717840|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717841|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717842|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717843|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717844|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717845|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717846|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717847|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717848|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717849|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717850|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717851|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717852|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717853|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717854|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717855|NCT00175019|E3|Reported Event|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
717856|NCT00175019|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
717857|NCT00175019|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
717998|NCT00174915|B5|Baseline|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
717860|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
717861|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
717862|NCT00175006|E1|Reported Event|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
717863|NCT00174967|B5|Baseline|Total|Total of all reporting groups
717864|NCT00174967|B4|Baseline|Placebo QD|Placebo, orally, once daily
717865|NCT00174967|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717866|NCT00174967|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717867|NCT00174967|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717868|NCT00174967|P4|Participant Flow|Placebo QD|Placebo, orally, once daily
717869|NCT00174967|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717870|NCT00174967|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717871|NCT00174967|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717872|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717873|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717874|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717875|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717876|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717877|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717878|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717879|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717880|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717881|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717882|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717883|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717884|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717885|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717886|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717887|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717888|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717889|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717890|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717891|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717892|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717893|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717894|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717895|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717896|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717897|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717898|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717899|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717900|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717901|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717902|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717903|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717904|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717905|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717906|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717907|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717908|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
717909|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717910|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717911|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717912|NCT00174967|E4|Reported Event|Placebo QD|Placebo, orally, once daily
717913|NCT00174967|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
717914|NCT00174967|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
717915|NCT00174967|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
717916|NCT00174954|B1|Baseline|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
717917|NCT00174954|P1|Participant Flow|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
717918|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
717919|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
717920|NCT00174954|E1|Reported Event|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
717921|NCT00174941|B4|Baseline|Total|Total of all reporting groups
717922|NCT00174941|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level
717923|NCT00174941|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level
717924|NCT00174941|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg orally, once daily, based on serum urate level.
717925|NCT00174941|P4|Participant Flow|Total Febuxostat|
719161|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
717936|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717937|NCT00174941|O4|Outcome|Total Febuxostat|
717938|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717939|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717940|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717941|NCT00174941|O4|Outcome|Total Febuxostat|
717942|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717943|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717944|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717945|NCT00174941|O4|Outcome|Total Febuxostat|
717946|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717947|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717948|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717949|NCT00174941|O4|Outcome|Total Febuxostat|
717950|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717951|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717952|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717953|NCT00174941|O4|Outcome|Total Febuxostat|
717954|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717955|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717956|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717957|NCT00174941|O4|Outcome|Total Febuxostat|
717958|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717959|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717960|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717961|NCT00174941|O4|Outcome|Total Febuxostat|
717962|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717963|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717964|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717965|NCT00174941|O4|Outcome|Total Febuxostat|
717966|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717967|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717968|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717969|NCT00174941|O4|Outcome|Total Febuxostat|
717970|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717971|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717972|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717973|NCT00174941|O4|Outcome|Total Febuxostat|
717974|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717975|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717976|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717977|NCT00174941|O4|Outcome|Total Febuxostat|
717978|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717979|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717980|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717981|NCT00174941|O4|Outcome|Total Febuxostat|
717982|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717983|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717984|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717985|NCT00174941|O4|Outcome|Total Febuxostat|
717986|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717987|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717988|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717989|NCT00174941|O4|Outcome|Total Febuxostat|
717990|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
717991|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
717992|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
717993|NCT00174941|E4|Reported Event|Febuxostat Total|
717994|NCT00174941|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily, based on serum urate level
717995|NCT00174941|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily, based on serum urate level
717996|NCT00174941|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg taken orally, once daily, based on serum urate level.
717997|NCT00174915|B6|Baseline|Total|Total of all reporting groups
717999|NCT00174915|B4|Baseline|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718000|NCT00174915|B3|Baseline|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718001|NCT00174915|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718002|NCT00174915|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718003|NCT00174915|P5|Participant Flow|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718004|NCT00174915|P4|Participant Flow|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718005|NCT00174915|P3|Participant Flow|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718006|NCT00174915|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718007|NCT00174915|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718008|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718009|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718010|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718011|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718012|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718013|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718014|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718015|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718016|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718017|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718018|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718019|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718020|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718021|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718022|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718023|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718024|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718025|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718026|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718027|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718028|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718029|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718030|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718031|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718032|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718033|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718034|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718035|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718036|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718037|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718038|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718039|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718040|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718041|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718042|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718043|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718219|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718044|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718045|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718046|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718047|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718048|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718049|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718050|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718051|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718052|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718053|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718054|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718055|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718056|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718057|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718058|NCT00174915|E5|Reported Event|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
718059|NCT00174915|E4|Reported Event|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
718060|NCT00174915|E3|Reported Event|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
718061|NCT00174915|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
718062|NCT00174915|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
718063|NCT00174785|B3|Baseline|Total|Total of all reporting groups
718064|NCT00174785|B2|Baseline|Placebo|matching placebo tablets
718065|NCT00174785|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718066|NCT00174785|P2|Participant Flow|Placebo|matching placebo tablets
718067|NCT00174785|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718068|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
718069|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718070|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
718071|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718072|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
718073|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718074|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
718075|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718076|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
718077|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718078|NCT00174785|E2|Reported Event|Placebo|matching placebo tablets
718079|NCT00174785|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
718080|NCT00174460|B3|Baseline|Total|Total of all reporting groups
718081|NCT00174460|B2|Baseline|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718082|NCT00174460|B1|Baseline|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718083|NCT00174460|P2|Participant Flow|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718084|NCT00174460|P1|Participant Flow|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718085|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718086|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718087|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718088|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718089|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718090|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718091|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718092|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718093|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718094|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718095|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718096|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718097|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718098|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718099|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718100|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718101|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718102|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718103|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718104|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718105|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718106|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718107|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718108|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718109|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718110|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718111|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
719162|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
718112|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718113|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718114|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718115|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718116|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718117|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718118|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718119|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718120|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718121|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718122|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718123|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718124|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718125|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718126|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718127|NCT00174460|E2|Reported Event|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
718128|NCT00174460|E1|Reported Event|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
718129|NCT00174447|B1|Baseline|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718130|NCT00174447|P1|Participant Flow|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718131|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718132|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718133|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718134|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718135|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718136|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718137|NCT00174447|E1|Reported Event|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
718138|NCT00174382|B1|Baseline|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718139|NCT00174382|P1|Participant Flow|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718140|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718141|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718142|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718143|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718144|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718145|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718146|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718147|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718148|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718149|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718150|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718151|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718152|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718153|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718154|NCT00174382|E1|Reported Event|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
718155|NCT00174291|B3|Baseline|Total|Total of all reporting groups
718156|NCT00174291|B2|Baseline|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718157|NCT00174291|B1|Baseline|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718158|NCT00174291|P2|Participant Flow|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718220|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718221|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718222|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718159|NCT00174291|P1|Participant Flow|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718160|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718161|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718162|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718163|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718164|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718165|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718166|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
719163|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
718167|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718168|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718169|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718170|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718171|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718172|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718173|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718174|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
719164|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
718175|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718176|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718177|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718178|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718179|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718180|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718181|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718182|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
719165|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
718183|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718184|NCT00174291|E2|Reported Event|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718185|NCT00174291|E1|Reported Event|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718186|NCT00174265|B3|Baseline|Total|Total of all reporting groups
718187|NCT00174265|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for 26 weeks
718188|NCT00174265|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for 26 weeks
718189|NCT00174265|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for 26 weeks
718190|NCT00174265|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for 26 weeks
718191|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
718192|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
718193|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
718194|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
718195|NCT00174265|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for 26 weeks
718196|NCT00174265|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for 26 weeks
718197|NCT00174252|B1|Baseline|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718198|NCT00174252|P1|Participant Flow|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718199|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718200|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718201|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718202|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718203|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718204|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718205|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718206|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
718207|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
718208|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
718209|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
718210|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
718211|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
718212|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
718213|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
718214|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718215|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718216|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718217|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718218|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718223|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718224|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718225|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718226|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718227|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718228|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718229|NCT00174252|E1|Reported Event|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
718230|NCT00174187|B3|Baseline|Total|Total of all reporting groups
718231|NCT00174187|B2|Baseline|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718232|NCT00174187|B1|Baseline|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718233|NCT00174187|P3|Participant Flow|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718234|NCT00174187|P2|Participant Flow|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718235|NCT00174187|P1|Participant Flow|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718236|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718237|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718238|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718239|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718240|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718241|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718242|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718243|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718244|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718245|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718246|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718247|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718248|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718249|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718250|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718251|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718252|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718253|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718254|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718255|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718256|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718257|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718258|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718259|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718260|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718261|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718262|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718263|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718264|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718265|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718266|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718267|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718268|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718269|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718270|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718271|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718272|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718273|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718274|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718275|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718276|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718277|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718278|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718279|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718280|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718281|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718282|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718283|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718284|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718285|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718286|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718287|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718288|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718289|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718290|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718291|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718292|NCT00174187|E3|Reported Event|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
718293|NCT00174187|E2|Reported Event|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718294|NCT00174187|E1|Reported Event|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
718295|NCT00172185|B5|Baseline|Total|Total of all reporting groups
718296|NCT00172185|B4|Baseline|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
718297|NCT00172185|B3|Baseline|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
718298|NCT00172185|B2|Baseline|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
718299|NCT00172185|B1|Baseline|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
718300|NCT00172185|P4|Participant Flow|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
718301|NCT00172185|P3|Participant Flow|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
718302|NCT00172185|P2|Participant Flow|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
718303|NCT00172185|P1|Participant Flow|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
718304|NCT00172185|O4|Outcome|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
718305|NCT00172185|O3|Outcome|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
718306|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
718307|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
718308|NCT00172185|O4|Outcome|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
718309|NCT00172185|O3|Outcome|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
718310|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
718311|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
718312|NCT00172185|E4|Reported Event|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
718313|NCT00172185|E3|Reported Event|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
718314|NCT00172185|E2|Reported Event|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
718315|NCT00172185|E1|Reported Event|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
718316|NCT00172042|B3|Baseline|Total|Total of all reporting groups
718317|NCT00172042|B2|Baseline|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718318|NCT00172042|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718319|NCT00172042|P2|Participant Flow|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718320|NCT00172042|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718321|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718322|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718323|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718324|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718325|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718326|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718327|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718328|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718329|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718330|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718331|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718332|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718498|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718333|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718334|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718335|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718336|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718337|NCT00172042|E2|Reported Event|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
718338|NCT00172042|E1|Reported Event|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
718339|NCT00171925|B3|Baseline|Total|Total of all reporting groups
718340|NCT00171925|B2|Baseline|Control|No Treatment with study medication.
718341|NCT00171925|B1|Baseline|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
718342|NCT00171925|P2|Participant Flow|Control|No Treatment with study medication.
718343|NCT00171925|P1|Participant Flow|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
718344|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
718345|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
718346|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
718347|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
718348|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
718349|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
718350|NCT00171925|E2|Reported Event|Control|No treatment with study medication.
718351|NCT00171925|E1|Reported Event|Zoledronic Acid|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
718352|NCT00171873|B3|Baseline|Total|Total of all reporting groups
718353|NCT00171873|B2|Baseline|Placebo|Sodium chloride intramuscularly every 28 days
718354|NCT00171873|B1|Baseline|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
718355|NCT00171873|P2|Participant Flow|Placebo|Sodium chloride intramuscularly every 28 days
718356|NCT00171873|P1|Participant Flow|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
718357|NCT00171873|O2|Outcome|Placebo|Sodium chloride intramuscularly every 28 days
718358|NCT00171873|O1|Outcome|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
718359|NCT00171873|E2|Reported Event|Placebo|Sodium chloride intramuscularly every 28 days
718360|NCT00171873|E1|Reported Event|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
718361|NCT00171834|B8|Baseline|Total|Total of all reporting groups
718362|NCT00171834|B7|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
718363|NCT00171834|B6|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
718364|NCT00171834|B5|Baseline|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718365|NCT00171834|B4|Baseline|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718366|NCT00171834|B3|Baseline|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718367|NCT00171834|B2|Baseline|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718368|NCT00171834|B1|Baseline|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718369|NCT00171834|P7|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
718370|NCT00171834|P6|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
718371|NCT00171834|P5|Participant Flow|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718372|NCT00171834|P4|Participant Flow|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718562|NCT00170846|B2|Baseline|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
718373|NCT00171834|P3|Participant Flow|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718374|NCT00171834|P2|Participant Flow|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718375|NCT00171834|P1|Participant Flow|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718376|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
718377|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
718378|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
718379|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
718380|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
718381|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
718382|NCT00171834|O1|Outcome|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
718383|NCT00171834|O13|Outcome|Patupilone 13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718384|NCT00171834|O12|Outcome|Patupilone 12.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718385|NCT00171834|O11|Outcome|Patupilone 11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718386|NCT00171834|O10|Outcome|Patupilone 11.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718387|NCT00171834|O9|Outcome|Patupilone 10.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718388|NCT00171834|O8|Outcome|Patupilone 10.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718389|NCT00171834|O7|Outcome|Patupilone 9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718390|NCT00171834|O6|Outcome|Patupilone 9.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718391|NCT00171834|O5|Outcome|Patupilone 8.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718392|NCT00171834|O4|Outcome|Patupilone 8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718393|NCT00171834|O3|Outcome|Patupilone 7.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718394|NCT00171834|O2|Outcome|Patupilone 7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718395|NCT00171834|O1|Outcome|Patupilone 6.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718396|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
718397|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
718398|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
718399|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
718400|NCT00171834|O5|Outcome|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718401|NCT00171834|O4|Outcome|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718402|NCT00171834|O3|Outcome|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718403|NCT00171834|O2|Outcome|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718404|NCT00171834|O1|Outcome|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718405|NCT00171834|E7|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
718406|NCT00171834|E6|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
718407|NCT00171834|E5|Reported Event|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718408|NCT00171834|E4|Reported Event|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718409|NCT00171834|E3|Reported Event|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718410|NCT00171834|E2|Reported Event|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718411|NCT00171834|E1|Reported Event|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
718412|NCT00171704|B3|Baseline|Total|Total of all reporting groups
718413|NCT00171704|B2|Baseline|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718414|NCT00171704|B1|Baseline|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718415|NCT00171704|P2|Participant Flow|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718416|NCT00171704|P1|Participant Flow|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718417|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718418|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718419|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718420|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718421|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718422|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718423|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718424|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718425|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718426|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718427|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718428|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718429|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718430|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718431|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718432|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
718433|NCT00171704|E2|Reported Event|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
718434|NCT00171704|E1|Reported Event|Letrozole|2.5 mg once daily q.d. orally for 5 years
718435|NCT00171340|B3|Baseline|Total|Total of all reporting groups
718436|NCT00171340|B2|Baseline|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718437|NCT00171340|B1|Baseline|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718438|NCT00171340|P2|Participant Flow|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718439|NCT00171340|P1|Participant Flow|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718440|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718441|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718442|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
718443|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
718444|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
718445|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
718446|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
718447|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
718448|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718449|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718450|NCT00171340|E2|Reported Event|Zolendronic Acid 4mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718451|NCT00171340|E1|Reported Event|Zoledronic Acid 4mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1 and Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718452|NCT00171314|B3|Baseline|Total|Total of all reporting groups
718453|NCT00171314|B2|Baseline|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718454|NCT00171314|B1|Baseline|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718455|NCT00171314|P2|Participant Flow|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718456|NCT00171314|P1|Participant Flow|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718457|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718458|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718459|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718460|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718461|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718462|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718463|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718464|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718465|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718466|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718467|NCT00171314|E2|Reported Event|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
718468|NCT00171314|E1|Reported Event|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
718469|NCT00171301|B3|Baseline|Total|Total of all reporting groups
718470|NCT00171301|B2|Baseline|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
718471|NCT00171301|B1|Baseline|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
718472|NCT00171301|P2|Participant Flow|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
718473|NCT00171301|P1|Participant Flow|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
718474|NCT00171301|O1|Outcome|Deferasirox (All Participants)|Participants received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
718475|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
718476|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
718477|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
718478|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
718479|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
718480|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
718481|NCT00171301|E2|Reported Event|Deferasirox (16 Years or Older)|Participants age 16 years and older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
718482|NCT00171301|E1|Reported Event|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
718483|NCT00171210|B3|Baseline|Total|Total of all reporting groups
718484|NCT00171210|B2|Baseline|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718485|NCT00171210|B1|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718486|NCT00171210|P2|Participant Flow|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718487|NCT00171210|P1|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718488|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718489|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718490|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718491|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718492|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718493|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718494|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718495|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718496|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718497|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
719166|NCT00168805|E3|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
718499|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718500|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718501|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718502|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718503|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718504|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718505|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718506|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718507|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718508|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718509|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718510|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
718511|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718512|NCT00171210|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
718513|NCT00171210|E1|Reported Event|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study continued this treatment in the extension study. Dosage based on body weight.
718514|NCT00171054|B3|Baseline|Total|Total of all reporting groups
718515|NCT00171054|B2|Baseline|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718516|NCT00171054|B1|Baseline|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718517|NCT00171054|P2|Participant Flow|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718518|NCT00171054|P1|Participant Flow|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718519|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718520|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718521|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718522|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718523|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718524|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718525|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718526|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718527|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718528|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718529|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718530|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718531|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
719167|NCT00168805|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
718532|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718533|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718534|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718535|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718536|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718537|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718538|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718539|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718540|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718541|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718542|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718543|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718544|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718545|NCT00171054|E2|Reported Event|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718546|NCT00171054|E1|Reported Event|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
718547|NCT00170950|B3|Baseline|Total|Total of all reporting groups
718548|NCT00170950|B2|Baseline|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718549|NCT00170950|B1|Baseline|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718550|NCT00170950|P2|Participant Flow|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718551|NCT00170950|P1|Participant Flow|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718552|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718553|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718554|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718555|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718556|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718557|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
718558|NCT00170950|E2|Reported Event|Benazepril / HCTZ|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily
718559|NCT00170950|E1|Reported Event|Benazepril / Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily
718560|NCT00170846|B4|Baseline|Total|Total of all reporting groups
718561|NCT00170846|B3|Baseline|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
718563|NCT00170846|B1|Baseline|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
718564|NCT00170846|P3|Participant Flow|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
718565|NCT00170846|P2|Participant Flow|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
718566|NCT00170846|P1|Participant Flow|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
718567|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
718568|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
718569|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
718570|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
718571|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
718572|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
718573|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
718574|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
718575|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
718576|NCT00170846|E3|Reported Event|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
718577|NCT00170846|E2|Reported Event|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
718578|NCT00170846|E1|Reported Event|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
718579|NCT00170625|B1|Baseline|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
718580|NCT00170625|P1|Participant Flow|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21 Carboplatin AUC 5 on day 3, q 21
718581|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
718582|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
718583|NCT00170625|E1|Reported Event|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
718584|NCT00170157|B1|Baseline|Entire Study Population|All participants initially randomized.
718585|NCT00170157|P2|Participant Flow|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily."
718586|NCT00170157|P1|Participant Flow|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.~MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
718587|NCT00170157|O2|Outcome|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily"
718588|NCT00170157|O1|Outcome|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.~MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
718589|NCT00170157|O1|Outcome|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.
718590|NCT00170157|E1|Reported Event|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.
718591|NCT00169442|B7|Baseline|Total|Total of all reporting groups
718592|NCT00169442|B6|Baseline|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718638|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718593|NCT00169442|B5|Baseline|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718594|NCT00169442|B4|Baseline|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718595|NCT00169442|B3|Baseline|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718596|NCT00169442|B2|Baseline|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718597|NCT00169442|B1|Baseline|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718598|NCT00169442|P6|Participant Flow|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718599|NCT00169442|P5|Participant Flow|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718600|NCT00169442|P4|Participant Flow|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718601|NCT00169442|P3|Participant Flow|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718602|NCT00169442|P2|Participant Flow|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718603|NCT00169442|P1|Participant Flow|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718604|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718605|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
718606|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
718607|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718608|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
718609|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
718610|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718611|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
718612|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
718613|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718614|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
718615|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
718616|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718617|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718618|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718619|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718620|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718621|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718622|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718623|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718624|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718625|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718626|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718627|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718628|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718629|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718630|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718631|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718632|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718633|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718634|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718635|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718636|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718637|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
719168|NCT00168805|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
718639|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718640|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718641|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718642|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718643|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718644|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718645|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718646|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718647|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718648|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718649|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718650|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718651|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718652|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718653|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718654|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718655|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718656|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718657|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718658|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718659|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718660|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718661|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718662|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718663|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718664|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718665|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718666|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718667|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718668|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718669|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718670|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718671|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718672|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718673|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718674|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718675|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718676|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718677|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718678|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718679|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718680|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718681|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718682|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718683|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718684|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718685|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718686|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718687|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718688|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718689|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718690|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718691|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718692|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718693|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718694|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718695|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718696|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718697|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718698|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718699|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718700|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718701|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718702|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718703|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
718749|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718750|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719169|NCT00168454|B7|Baseline|Total|Total of all reporting groups
718704|NCT00169442|E5|Reported Event|PRP TRITANRIX-HEPB KFT. REF GROUP|Healthy male and female infants who were primed with Tritanrix ™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
718705|NCT00169442|E4|Reported Event|PRP TRITANRIX-HEPB KFT. MIX GROUP|Healthy male and female infants who were primed with Tritanrix ™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
718706|NCT00169442|E3|Reported Event|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
718707|NCT00169442|E2|Reported Event|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
718708|NCT00169442|E1|Reported Event|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
718709|NCT00168844|B4|Baseline|Total|Total of all reporting groups
718710|NCT00168844|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718711|NCT00168844|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718712|NCT00168844|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718713|NCT00168844|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718714|NCT00168844|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718715|NCT00168844|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718716|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718717|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718718|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718719|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718720|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718721|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718722|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718723|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718724|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718725|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718726|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718727|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718728|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718729|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718730|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718731|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718732|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718733|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718734|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718735|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718736|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718737|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718738|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718739|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718740|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718741|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718742|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718743|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718744|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718745|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718746|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718747|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718748|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719137|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
718751|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718752|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718753|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718754|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718755|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718756|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718757|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718758|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718759|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718760|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718761|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718762|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718763|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718764|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718765|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718766|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718767|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718768|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718769|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718770|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718771|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718772|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718773|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718774|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718775|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718776|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718777|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718778|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718779|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718780|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718781|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718782|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718783|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718784|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718785|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718786|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718787|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718788|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718789|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718790|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718791|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718792|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718793|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718794|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718795|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718796|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718797|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718798|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718799|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718800|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718801|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718802|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718803|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718804|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718805|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718806|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718807|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718808|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718809|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718810|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718811|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718812|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718813|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718814|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718815|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718816|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718817|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718818|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718819|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718820|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718821|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718822|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718823|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718824|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718825|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718826|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718827|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718828|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718829|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718830|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718831|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718832|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718833|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718834|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718835|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718836|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718837|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718838|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718839|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718840|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718841|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718842|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718843|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718844|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718845|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718846|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718847|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718848|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718849|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718850|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718851|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718852|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718853|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718854|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718855|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718856|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718857|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718858|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718859|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718860|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718861|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718862|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718863|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718864|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718865|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718866|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718867|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718868|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718869|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718870|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718871|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718872|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718873|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718874|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718875|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718876|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718877|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718878|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718879|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718880|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718881|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718882|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718883|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718884|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718885|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718886|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718887|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718888|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718889|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718890|NCT00168844|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718891|NCT00168844|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718892|NCT00168844|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718893|NCT00168831|B4|Baseline|Total|Total of all reporting groups
718894|NCT00168831|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718895|NCT00168831|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718896|NCT00168831|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718897|NCT00168831|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718898|NCT00168831|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718899|NCT00168831|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718900|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718901|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718902|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718903|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718904|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718905|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718906|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718907|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718908|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718909|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718910|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718911|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718912|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718913|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718914|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718915|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718916|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718917|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718918|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718919|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718920|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718921|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718922|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718923|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718924|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718925|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718926|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718927|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718928|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718929|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718930|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718931|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718932|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718933|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718934|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718935|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718936|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718937|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718938|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718939|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718940|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718941|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718942|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718943|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718944|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718945|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718946|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718947|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718948|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718949|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718950|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718951|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718952|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718953|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718954|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718955|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718956|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718957|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718958|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718959|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718960|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718961|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718962|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718963|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718964|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718965|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718966|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718967|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718968|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718969|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718970|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718971|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718972|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718973|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718974|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718975|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718976|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718977|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718978|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718979|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718980|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718981|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718982|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718983|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718984|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718985|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718986|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718987|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718988|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718989|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718990|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718991|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718992|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718993|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718994|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718995|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718996|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
718997|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
718998|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
718999|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719000|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719001|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719002|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719003|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719004|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719005|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719006|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719007|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719008|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719009|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719010|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719011|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719012|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719013|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719014|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719015|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719016|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719017|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719018|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719019|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719020|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719021|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719022|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719023|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719024|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719025|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719026|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719027|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719028|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719029|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719030|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719031|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719032|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719033|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719034|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719035|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719036|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719037|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719038|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719039|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719040|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719041|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719042|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719043|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719044|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719045|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719046|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719047|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719048|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719049|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719050|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719051|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719052|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719053|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719054|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719055|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719056|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719057|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719058|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719059|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719060|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719061|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719062|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719063|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719064|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719065|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719066|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719067|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719068|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719069|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719070|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719071|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719072|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719073|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719074|NCT00168831|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
719075|NCT00168831|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
719076|NCT00168831|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
719077|NCT00168818|B4|Baseline|Total|Total of all reporting groups
719078|NCT00168818|B3|Baseline|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719079|NCT00168818|B2|Baseline|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719080|NCT00168818|B1|Baseline|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719081|NCT00168818|P3|Participant Flow|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719082|NCT00168818|P2|Participant Flow|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719083|NCT00168818|P1|Participant Flow|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719084|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719085|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719086|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719087|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719088|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719089|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719090|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719091|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719092|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719093|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719094|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719095|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719096|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719097|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719098|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719099|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719100|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719101|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719102|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719103|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719104|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719105|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719106|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719107|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719108|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719109|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719110|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719111|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719112|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719113|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719114|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719115|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719116|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719117|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719118|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719119|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719120|NCT00168818|E3|Reported Event|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
719121|NCT00168818|E2|Reported Event|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719122|NCT00168818|E1|Reported Event|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
719123|NCT00168805|B4|Baseline|Total|Total of all reporting groups
719124|NCT00168805|B3|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
719125|NCT00168805|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
719126|NCT00168805|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
719127|NCT00168805|P3|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
719128|NCT00168805|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
719129|NCT00168805|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
719130|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
719131|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
719132|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
719133|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
719134|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
719135|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
719136|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
719170|NCT00168454|B6|Baseline|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719171|NCT00168454|B5|Baseline|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719172|NCT00168454|B4|Baseline|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719173|NCT00168454|B3|Baseline|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719174|NCT00168454|B2|Baseline|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719175|NCT00168454|B1|Baseline|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719176|NCT00168454|P6|Participant Flow|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719177|NCT00168454|P5|Participant Flow|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719178|NCT00168454|P4|Participant Flow|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719179|NCT00168454|P3|Participant Flow|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719180|NCT00168454|P2|Participant Flow|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719181|NCT00168454|P1|Participant Flow|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719182|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719183|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719184|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719185|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719186|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719187|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719188|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719189|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719190|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719191|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719192|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719193|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719194|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719195|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719196|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719197|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719198|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719199|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719200|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719201|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719202|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719203|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719204|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719205|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719206|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719207|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719208|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719209|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719210|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719211|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719212|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719213|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719214|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719215|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719216|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719217|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719218|NCT00168454|E6|Reported Event|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
719219|NCT00168454|E5|Reported Event|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
719220|NCT00168454|E4|Reported Event|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
719221|NCT00168454|E3|Reported Event|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
719222|NCT00168454|E2|Reported Event|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
719223|NCT00168454|E1|Reported Event|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
719224|NCT00168428|B3|Baseline|Total|Total of all reporting groups
719225|NCT00168428|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719226|NCT00168428|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719337|NCT00168311|E2|Reported Event|Sham Treatment|Sham bilateral rTMS treatment
719338|NCT00168311|E1|Reported Event|Active Treatment|Bilateral high frequency (10Hz) rTMS
719227|NCT00168428|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719228|NCT00168428|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719229|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719230|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719231|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719232|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719233|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719234|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719235|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719236|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719237|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719238|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719239|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719240|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719241|NCT00168428|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
719242|NCT00168428|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
719243|NCT00168389|B4|Baseline|Total|Total of all reporting groups
719244|NCT00168389|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719245|NCT00168389|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719246|NCT00168389|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719247|NCT00168389|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719248|NCT00168389|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719249|NCT00168389|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719250|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719251|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719252|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719253|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719339|NCT00168298|B4|Baseline|Total|Total of all reporting groups
719593|NCT00166504|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
719254|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719255|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719256|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719257|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719258|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719259|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719260|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719261|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719262|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719263|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719264|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719265|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719266|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719267|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719268|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719269|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719270|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719271|NCT00168389|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719272|NCT00168389|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719273|NCT00168389|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719274|NCT00168337|B4|Baseline|Total|Total of all reporting groups
719275|NCT00168337|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719276|NCT00168337|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719277|NCT00168337|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719278|NCT00168337|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719279|NCT00168337|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719280|NCT00168337|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719281|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719282|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719283|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719284|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719285|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719286|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719287|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719288|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719517|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
719289|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719290|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719291|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719292|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719293|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719294|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719295|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719296|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719297|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719298|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719299|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719300|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719301|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719302|NCT00168337|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
719303|NCT00168337|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719304|NCT00168337|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
719305|NCT00168324|B4|Baseline|Total|Total of all reporting groups
719306|NCT00168324|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719307|NCT00168324|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719308|NCT00168324|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
719309|NCT00168324|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719310|NCT00168324|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719311|NCT00168324|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
719312|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
719313|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719314|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
719315|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
719316|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719317|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
719318|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
719319|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719320|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
719321|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
719322|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719323|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
719324|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
719325|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719326|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
719327|NCT00168324|E3|Reported Event|Sham Injection|Sham injection on Day 0.
719328|NCT00168324|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719329|NCT00168324|E1|Reported Event|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
719330|NCT00168311|B3|Baseline|Total|Total of all reporting groups
719331|NCT00168311|B2|Baseline|Sham Treatment|Sham bilateral rTMS treatment
719332|NCT00168311|B1|Baseline|Active Treatment|Bilateral high frequency (10Hz) rTMS
719333|NCT00168311|P2|Participant Flow|Sham Treatment|Sham bilateral rTMS treatment
719334|NCT00168311|P1|Participant Flow|Active Treatment|Bilateral high frequency (10Hz) rTMS
719335|NCT00168311|O2|Outcome|Sham Treatment|Sham bilateral rTMS treatment
719336|NCT00168311|O1|Outcome|Active Treatment|Bilateral high frequency (10Hz) rTMS
719340|NCT00168298|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719341|NCT00168298|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719342|NCT00168298|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
719343|NCT00168298|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719344|NCT00168298|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
719345|NCT00168298|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
719346|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
719347|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719348|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
719349|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
719350|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719351|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
719352|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
719353|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719354|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
719355|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
719356|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719357|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
719358|NCT00168298|E3|Reported Event|Sham Injection|Sham injection on Day 0.
719359|NCT00168298|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
719360|NCT00168298|E1|Reported Event|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
719361|NCT00168103|B4|Baseline|Total|Total of all reporting groups
719362|NCT00168103|B3|Baseline|Placebo|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the Placebo arm were included in the ITT analysis population.
719363|NCT00168103|B2|Baseline|C1-INH 20 U/kg bw|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the C1-INH 20 U/kg bw arm were included in the ITT analysis population.
719364|NCT00168103|B1|Baseline|C1-INH 10 U/kg bw|Baseline characteristics were calculated only for the intention to treat (ITT) and per protocol (PP) analysis populations, not for all enrolled subjects. Baseline data presented here are for subjects included in the ITT population. One (1) subject enrolled and randomized to the C1-INH 10 U/kg bw group was excluded from the ITT analysis population.
719365|NCT00168103|P4|Participant Flow|Not Randomized|Includes one subject enrolled who was not randomized but received treatment with 20 U/kg bw C1-INH.
719366|NCT00168103|P3|Participant Flow|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
719367|NCT00168103|P2|Participant Flow|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
719368|NCT00168103|P1|Participant Flow|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1 Esterase Inhibitor (C1-INH) 10 Units (U)/kg body weight (bw) arm.
719369|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
719370|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
719371|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
719372|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
719373|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
719374|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
719375|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
719376|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
719377|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
719378|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
719379|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
719380|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
719381|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
719382|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
719383|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
719384|NCT00168103|E3|Reported Event|Placebo|Includes subjects receiving Placebo and no rescue study medication within 4 hours after the start of the initial treatment.
719385|NCT00168103|E2|Reported Event|C1-INH 20 U/kg bw|Includes subjects receiving 20 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment (n=43). An additional 3 subjects not randomized to but treated with 20 U/kg bw C1-INH in this time period were also included in this group for the safety analysis.
719386|NCT00168103|E1|Reported Event|C1-INH 10 U/kg bw|Includes subjects receiving 10 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment.
719387|NCT00168064|B3|Baseline|Total|Total of all reporting groups
719831|NCT00165672|B3|Baseline|Total|Total of all reporting groups
719388|NCT00168064|B2|Baseline|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
719389|NCT00168064|B1|Baseline|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
719390|NCT00168064|P2|Participant Flow|AP- Mechlorethamine 0.02% Compounded in Aquaphor|Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
719391|NCT00168064|P1|Participant Flow|PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel|Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
719392|NCT00168064|O2|Outcome|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
719393|NCT00168064|O1|Outcome|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
719394|NCT00168064|O2|Outcome|AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%|Mechlorethamine-MCH (Nitrogen Mustard) compounded in Aquaphor 0.02%
719395|NCT00168064|O1|Outcome|PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
719396|NCT00168064|E2|Reported Event|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
719397|NCT00168064|E1|Reported Event|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
719398|NCT00168038|B1|Baseline|IgPro10|All subjects treated with IgPro10
719399|NCT00168038|P1|Participant Flow|IgPro10|All subjects treated with IgPro10
719400|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719401|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719402|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719403|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719404|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719405|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719406|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719407|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719408|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
719409|NCT00168038|E1|Reported Event|IgPro10|All subjects treated with IgPro10
719410|NCT00167778|B1|Baseline|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
719411|NCT00167778|P1|Participant Flow|Amputee|This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4.
719412|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719413|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719414|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719415|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719416|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719417|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719418|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719419|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719420|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719421|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719422|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719423|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719424|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719425|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719426|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719427|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719994|NCT00163020|B3|Baseline|Total|Total of all reporting groups
719428|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719429|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719430|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719431|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719432|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719433|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719434|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719435|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719436|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719437|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719438|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719439|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719440|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719441|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719442|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719443|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719444|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719445|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719446|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719447|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719448|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719449|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719450|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719451|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719452|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719453|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719454|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719455|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719456|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
719457|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
719458|NCT00167778|E1|Reported Event|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
719459|NCT00167544|B3|Baseline|Total|Total of all reporting groups
719460|NCT00167544|B2|Baseline|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719461|NCT00167544|B1|Baseline|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719518|NCT00167245|O1|Outcome|Topirmate|"topiramate~Topiramate : 300mg/day for 13 weeks"
719519|NCT00167245|E2|Reported Event|Placebo|placebo : placebo pills
719462|NCT00167544|P2|Participant Flow|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719463|NCT00167544|P1|Participant Flow|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719464|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719465|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719466|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719467|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719468|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719469|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719470|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719471|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719472|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719473|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719474|NCT00167544|E2|Reported Event|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
719475|NCT00167544|E1|Reported Event|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
719476|NCT00167414|B1|Baseline|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719477|NCT00167414|P1|Participant Flow|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719478|NCT00167414|O1|Outcome|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719479|NCT00167414|O1|Outcome|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719480|NCT00167414|O1|Outcome|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719481|NCT00167414|O1|Outcome|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719520|NCT00167245|E1|Reported Event|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
719521|NCT00167206|B1|Baseline|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719482|NCT00167414|O1|Outcome|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719483|NCT00167414|E1|Reported Event|Hypofractionated Stereotactic Body Radiation Therapy|"Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy~Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary."
719484|NCT00167388|B5|Baseline|Total|Total of all reporting groups
719485|NCT00167388|B4|Baseline|Group 4|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight >1250 at time of study and randomized to not feeding during the PRBC transfusion"
719486|NCT00167388|B3|Baseline|Group 3|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight >1250 at time of study and randomized to feeding during the PRBC transfusion"
719487|NCT00167388|B2|Baseline|Group 2|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight <1250 at time of study and randomized to not feeding during the PRBC transfusion"
719488|NCT00167388|B1|Baseline|Group 1|"Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.~Weight <1250 at time of study and randomized to feeding during the PRBC transfusion"
719489|NCT00167388|P4|Participant Flow|Group 4|>1250 gm at time of study, Not fed during PRBC transfusion
719490|NCT00167388|P3|Participant Flow|Group 3|>1250 gm at time of study, Fed during PRBC transfusion
719491|NCT00167388|P2|Participant Flow|Group 2|<1250 gm at time of study, Not fed during PRBC transfusion
719492|NCT00167388|P1|Participant Flow|Group 1|<1250 gm at time of study, Fed during PRBC transfusion
719493|NCT00167388|O2|Outcome|Groups 3 and 4|Infants >1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
719494|NCT00167388|O1|Outcome|Groups 1 and 2|Infants <1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
719495|NCT00167388|E4|Reported Event|Group 4|>1250 gm, not fed during the study
719496|NCT00167388|E3|Reported Event|Group 3|>1250 gm, fed during the study
719497|NCT00167388|E2|Reported Event|Group 2|<1250 gm, not fed during the study
719498|NCT00167388|E1|Reported Event|Group 1|< 1250 gm Fed during the study
719499|NCT00167310|B3|Baseline|Total|Total of all reporting groups
719500|NCT00167310|B2|Baseline|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719501|NCT00167310|B1|Baseline|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719502|NCT00167310|P2|Participant Flow|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719503|NCT00167310|P1|Participant Flow|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719504|NCT00167310|O2|Outcome|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719505|NCT00167310|O1|Outcome|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719506|NCT00167310|O2|Outcome|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719507|NCT00167310|O1|Outcome|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719508|NCT00167310|E2|Reported Event|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719509|NCT00167310|E1|Reported Event|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
719510|NCT00167245|B3|Baseline|Total|Total of all reporting groups
719511|NCT00167245|B2|Baseline|Group 2|placebo : placebo pills
719512|NCT00167245|B1|Baseline|Group 1|"topiramate~Topiramate : 300mg/day for 13 weeks"
719513|NCT00167245|P2|Participant Flow|Placebo|placebo : placebo pills
719514|NCT00167245|P1|Participant Flow|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
719515|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
719516|NCT00167245|O1|Outcome|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
719522|NCT00167206|P1|Participant Flow|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719523|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719524|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719525|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719526|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719527|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719528|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719529|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719530|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719531|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719532|NCT00167206|E1|Reported Event|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
719533|NCT00167180|B3|Baseline|Total|Total of all reporting groups
719534|NCT00167180|B2|Baseline|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
719535|NCT00167180|B1|Baseline|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
719536|NCT00167180|P2|Participant Flow|Non-CML or CML Failing Donor Lymphocyte Infusion|"Patients with non-CML or CML who have failed DLI and will receive Induction Chemotherapy + DLI.~Induction Chemotherapy + DLI: Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV Donor Lymphocyte Infusion (DLI)"
719537|NCT00167180|P1|Participant Flow|Chronic Myelogenous Leukemia (CML)|"Patients who have failed or refused Gleevec (TM) therapy and will receive Donor Lymphocyte Infusion.~Donor Lymphocyte Infusion: donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg"
719538|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
719539|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
719540|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
719541|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
719542|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
719543|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
719544|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
719545|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
719546|NCT00167180|O2|Outcome|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
719547|NCT00167180|O1|Outcome|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
719548|NCT00167180|E2|Reported Event|DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg|
719549|NCT00167180|E1|Reported Event|DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg|
719550|NCT00167102|B3|Baseline|Total|Total of all reporting groups
719551|NCT00167102|B2|Baseline|Placebo|
719552|NCT00167102|B1|Baseline|Alefacept|
719553|NCT00167102|P2|Participant Flow|Placebo|Weekly IM administration of placebo, for 12 weeks, followed by a 12-week, posttreatment observation period.
719554|NCT00167102|P1|Participant Flow|Alefacept|Weekly IM administration of alefacept,15 mg, for 12 weeks, followed by a 12-week, posttreatment observation period.
719555|NCT00167102|O2|Outcome|Placebo|
719556|NCT00167102|O1|Outcome|Alefacept|
719557|NCT00167102|O2|Outcome|Placebo|Weekly intramuscular administration of placebo 15 mg for 12 weeks
719558|NCT00167102|O1|Outcome|Alefacept|Weekly intramuscular administration of alefacept 15mg for 12 weeks
719559|NCT00167102|E2|Reported Event|Placebo|
719560|NCT00167102|E1|Reported Event|Alefacept|
719561|NCT00166712|B3|Baseline|Total|Total of all reporting groups
719562|NCT00166712|B2|Baseline|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
719563|NCT00166712|B1|Baseline|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC (Prograf) started on the 1st day after surgery, and then taken by mouth twice daily.
719564|NCT00166712|P2|Participant Flow|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
719565|NCT00166712|P1|Participant Flow|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
719591|NCT00166504|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
719592|NCT00166504|B1|Baseline|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
719566|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
719567|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
719568|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
719569|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
719570|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
719571|NCT00166712|O1|Outcome|Group 1|Evaluated for rejection of their transplanted kidney with a biopsy.
719572|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
719573|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
719574|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
719575|NCT00166712|O1|Outcome|Groups|Evaluated for rejection of their transplanted kidney with a biopsy.
719576|NCT00166712|E3|Reported Event|Group 1: Post-conversion to Sirolimus|After conversion to Sirolimus, if no rejection of transplanted kidney within 9 months post-transplant, will be weaned off Sirolimus.
719577|NCT00166712|E2|Reported Event|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
719578|NCT00166712|E1|Reported Event|Group 1: Alemtuzumab + TAC + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
719579|NCT00166517|B3|Baseline|Total|Total of all reporting groups
719580|NCT00166517|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719581|NCT00166517|B1|Baseline|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719582|NCT00166517|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719583|NCT00166517|P1|Participant Flow|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719584|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719585|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719586|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719587|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719588|NCT00166517|E2|Reported Event|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719589|NCT00166517|E1|Reported Event|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
719590|NCT00166504|B3|Baseline|Total|Total of all reporting groups
719594|NCT00166504|P1|Participant Flow|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
719595|NCT00166504|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
719596|NCT00166504|O1|Outcome|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
719597|NCT00166504|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
719598|NCT00166504|E1|Reported Event|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
719599|NCT00166361|B3|Baseline|Total|Total of all reporting groups
719600|NCT00166361|B2|Baseline|JJ Stent|Subjects assigned to this arm received a JJ stent.
719601|NCT00166361|B1|Baseline|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
719602|NCT00166361|P2|Participant Flow|JJ Stent|Subjects assigned to this arm received a JJ stent.
719603|NCT00166361|P1|Participant Flow|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
719604|NCT00166361|O2|Outcome|JJ Stent|Subjects assigned to this arm received a JJ stent.
719605|NCT00166361|O1|Outcome|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
719606|NCT00166361|E2|Reported Event|JJ Stent|Subjects assigned to this arm received a JJ stent.
719607|NCT00166361|E1|Reported Event|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
719608|NCT00166296|B3|Baseline|Total|Total of all reporting groups
719609|NCT00166296|B2|Baseline|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719610|NCT00166296|B1|Baseline|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719611|NCT00166296|P2|Participant Flow|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719612|NCT00166296|P1|Participant Flow|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719613|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719614|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719615|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719616|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719617|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719618|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719619|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719620|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719621|NCT00166296|E2|Reported Event|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719622|NCT00166296|E1|Reported Event|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
719623|NCT00166205|B1|Baseline|Swedish Adjustable Gastric Band (SAGB)|
719624|NCT00166205|P1|Participant Flow|Swedish Adjustable Gastric Band (SAGB)|
719625|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719626|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719627|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719628|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719629|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719630|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719631|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719632|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719633|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719634|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719635|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
719636|NCT00166205|E1|Reported Event|Swedish Adjustable Gastric Band (SAGB)|
719637|NCT00166166|B3|Baseline|Total|Total of all reporting groups
719638|NCT00166166|B2|Baseline|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
719639|NCT00166166|B1|Baseline|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
719640|NCT00166166|P2|Participant Flow|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
719641|NCT00166166|P1|Participant Flow|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
719642|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin, fluconazole and tetraethylammonium (TEA)
719643|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and fluconazole
719644|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and Tetraethylammonium (TEA)
719645|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin
719646|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
719647|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
719648|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of fluconazole and Tetraethylammonium (TEA)
719649|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA) and fluconazole
719650|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA), and fluconazole
719651|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole
719652|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole.
719653|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
719654|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
719655|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
719656|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
719657|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA)
719658|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA).
719659|NCT00166166|E2|Reported Event|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
719660|NCT00166166|E1|Reported Event|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
719661|NCT00166114|B3|Baseline|Total|Total of all reporting groups
719662|NCT00166114|B2|Baseline|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
719663|NCT00166114|B1|Baseline|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56
719664|NCT00166114|P2|Participant Flow|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
719665|NCT00166114|P1|Participant Flow|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
719666|NCT00166114|O2|Outcome|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
719667|NCT00166114|O1|Outcome|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
719668|NCT00166114|E2|Reported Event|Desipramine|25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
719669|NCT00166114|E1|Reported Event|Escitalopram|10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
719670|NCT00166036|B3|Baseline|Total|Total of all reporting groups
719671|NCT00166036|B2|Baseline|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
719672|NCT00166036|B1|Baseline|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
719673|NCT00166036|P2|Participant Flow|Pravastatin 80 mg|Once Daily for 12 Weeks
719674|NCT00166036|P1|Participant Flow|Atorvastatin 10 mg|Once Daily for 12 Weeks
719675|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
719676|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg daily
719677|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
719678|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg taken daily
719679|NCT00166036|E2|Reported Event|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
719680|NCT00166036|E1|Reported Event|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
719681|NCT00165984|B1|Baseline|Single Ventricle Patients|Patients born with single ventricle heart disease
719682|NCT00165984|P1|Participant Flow|Single Ventricle Patients|Patients born with single ventricle heart disease
719683|NCT00165984|O3|Outcome|Heterozygotes|Transplant-free survival for patients heterozygous (G/T) at nucleotide 5665 at 7 years.
719684|NCT00165984|O2|Outcome|Homozygous for Wild-type ppET1 5665|Transplant-free survival for patients homozygous for G at nucleotide 5665 at 7 years.
721349|NCT00157755|B3|Baseline|Total|Total of all reporting groups
719685|NCT00165984|O1|Outcome|Preproendothelin-1 (ppET1) 5665 Polymorphism Homozygotes|Transplant-free survival for patients homozygous for T at nucleotide 5665 at 7 years.
719686|NCT00165984|O1|Outcome|Incidence of Preproendothelin-1 5665 Polymorphism|Incidence of Homozygosity for mutation at nucleotide 5665
719687|NCT00165984|E1|Reported Event|Single Ventricle Patients|Patients born with single ventricle heart disease
719688|NCT00165958|B3|Baseline|Total|Total of all reporting groups
719689|NCT00165958|B2|Baseline|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
719690|NCT00165958|B1|Baseline|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
719691|NCT00165958|P2|Participant Flow|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
719692|NCT00165958|P1|Participant Flow|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
719693|NCT00165958|O2|Outcome|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
719694|NCT00165958|O1|Outcome|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
719695|NCT00165958|E2|Reported Event|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
719696|NCT00165958|E1|Reported Event|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
719697|NCT00165841|B3|Baseline|Total|Total of all reporting groups
719698|NCT00165841|B2|Baseline|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
719699|NCT00165841|B1|Baseline|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
719700|NCT00165841|P2|Participant Flow|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
719701|NCT00165841|P1|Participant Flow|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
719702|NCT00165841|O2|Outcome|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
719703|NCT00165841|O1|Outcome|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
719704|NCT00165841|E2|Reported Event|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
719705|NCT00165841|E1|Reported Event|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
719706|NCT00165789|B5|Baseline|Total|Total of all reporting groups
719707|NCT00165789|B4|Baseline|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719708|NCT00165789|B3|Baseline|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719709|NCT00165789|B2|Baseline|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719710|NCT00165789|B1|Baseline|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719711|NCT00165789|P4|Participant Flow|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719712|NCT00165789|P3|Participant Flow|Cohort 2- Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719713|NCT00165789|P2|Participant Flow|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719714|NCT00165789|P1|Participant Flow|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719715|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719716|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719717|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719718|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719719|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719720|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719721|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719722|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719723|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719724|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719725|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719726|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719727|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719728|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719729|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719730|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719731|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719732|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719733|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719734|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719735|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719736|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719737|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719738|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719739|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719740|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719741|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719742|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719743|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719744|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719745|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719746|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719747|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719748|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719749|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719750|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719751|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719752|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719753|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719754|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719755|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719756|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719757|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719758|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719759|NCT00165789|E4|Reported Event|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
719760|NCT00165789|E3|Reported Event|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719761|NCT00165789|E2|Reported Event|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
719762|NCT00165789|E1|Reported Event|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
719763|NCT00165776|B5|Baseline|Total|Total of all reporting groups
719764|NCT00165776|B4|Baseline|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719765|NCT00165776|B3|Baseline|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose. One subject from the 5,000 U/2 mL did not receive treatment after randomization.
719766|NCT00165776|B2|Baseline|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719767|NCT00165776|B1|Baseline|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose. Two subjects from the placebo group did not receive treatment after randomization.
719768|NCT00165776|P4|Participant Flow|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719769|NCT00165776|P3|Participant Flow|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
721345|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
719770|NCT00165776|P2|Participant Flow|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719771|NCT00165776|P1|Participant Flow|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719772|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719773|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719774|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719775|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719776|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719777|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719778|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719779|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719780|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719781|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719782|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719783|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719784|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719785|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719786|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719787|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719788|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719789|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719790|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719791|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719792|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719793|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719794|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719795|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719796|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719797|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719798|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719799|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719800|NCT00165776|E4|Reported Event|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719801|NCT00165776|E3|Reported Event|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719802|NCT00165776|E2|Reported Event|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
719803|NCT00165776|E1|Reported Event|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
719804|NCT00165698|B3|Baseline|Total|Total of all reporting groups
719805|NCT00165698|B2|Baseline|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719806|NCT00165698|B1|Baseline|Menatetrenone|15 mg t.i.d. orally for 12 months
719807|NCT00165698|P2|Participant Flow|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719808|NCT00165698|P1|Participant Flow|Menatetrenone|15 mg t.i.d. orally for 12 months
719809|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719810|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719811|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719812|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719813|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719814|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719815|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719816|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719817|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719818|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719819|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719820|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719821|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719822|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719823|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719824|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719825|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719826|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719827|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719828|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
719829|NCT00165698|E2|Reported Event|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
719830|NCT00165698|E1|Reported Event|Menatetrenone|15 mg t.i.d. orally for 12 months
719832|NCT00165672|B2|Baseline|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
719833|NCT00165672|B1|Baseline|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
719834|NCT00165672|P2|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
719835|NCT00165672|P1|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
719836|NCT00165672|O2|Outcome|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
719837|NCT00165672|O1|Outcome|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
719838|NCT00165672|E2|Reported Event|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
719839|NCT00165672|E1|Reported Event|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
719840|NCT00165646|B4|Baseline|Total|Total of all reporting groups
719841|NCT00165646|B3|Baseline|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
719842|NCT00165646|B2|Baseline|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
719843|NCT00165646|B1|Baseline|Placebo|once daily orally for 4 weeks
719844|NCT00165646|P3|Participant Flow|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
719845|NCT00165646|P2|Participant Flow|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
719846|NCT00165646|P1|Participant Flow|Placebo|once daily orally for 4 weeks
719847|NCT00165646|O3|Outcome|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
719848|NCT00165646|O2|Outcome|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
719849|NCT00165646|O1|Outcome|Placebo|once daily orally for 4 weeks
719850|NCT00165646|E3|Reported Event|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
719851|NCT00165646|E2|Reported Event|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
719852|NCT00165646|E1|Reported Event|Placebo|once daily orally for 4 weeks
719853|NCT00165503|B1|Baseline|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
719854|NCT00165503|P1|Participant Flow|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
719855|NCT00165503|O1|Outcome|Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
719856|NCT00165503|E1|Reported Event|Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.
719857|NCT00163657|B4|Baseline|Total|Total of all reporting groups
719858|NCT00163657|B3|Baseline|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
719859|NCT00163657|B2|Baseline|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
719860|NCT00163657|B1|Baseline|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
719861|NCT00163657|P3|Participant Flow|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
719862|NCT00163657|P2|Participant Flow|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
719863|NCT00163657|P1|Participant Flow|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
719864|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
719865|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
719866|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
719867|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
719868|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
719869|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
719870|NCT00163657|E3|Reported Event|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
719871|NCT00163657|E2|Reported Event|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
719872|NCT00163657|E1|Reported Event|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
719873|NCT00163293|B4|Baseline|Total|Total of all reporting groups
719874|NCT00163293|B3|Baseline|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719875|NCT00163293|B2|Baseline|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719876|NCT00163293|B1|Baseline|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719877|NCT00163293|P3|Participant Flow|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
720042|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
719878|NCT00163293|P2|Participant Flow|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719879|NCT00163293|P1|Participant Flow|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719880|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719881|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719882|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719883|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719884|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719885|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719886|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719887|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719888|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719889|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719890|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719891|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719892|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719893|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719894|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719895|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719896|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719897|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719898|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719899|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719900|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719901|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719902|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719903|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719904|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719905|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719906|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719907|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719908|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719909|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719910|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719911|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719912|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719913|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719914|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719915|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719916|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719917|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719918|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719919|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719920|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719921|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719922|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719923|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719924|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719925|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719926|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719927|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719928|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719929|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719930|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719931|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719932|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719933|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719934|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719935|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719936|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719937|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719938|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719939|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719940|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719941|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719942|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719943|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719944|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719945|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719946|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719947|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719948|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719949|NCT00163293|E3|Reported Event|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719950|NCT00163293|E2|Reported Event|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719951|NCT00163293|E1|Reported Event|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
719952|NCT00163215|B1|Baseline|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719953|NCT00163215|P1|Participant Flow|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719954|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719955|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719956|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719957|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719958|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719959|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719960|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719961|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719962|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719963|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719964|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719965|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719966|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719967|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719968|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719969|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719970|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719971|NCT00163215|E1|Reported Event|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
719972|NCT00163189|B1|Baseline|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719973|NCT00163189|P1|Participant Flow|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719974|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719975|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719976|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719977|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719978|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719979|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719980|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719981|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719982|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719983|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719984|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719985|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719986|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719987|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719988|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719989|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719990|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719991|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719992|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719993|NCT00163189|E1|Reported Event|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
719995|NCT00163020|B2|Baseline|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
719996|NCT00163020|B1|Baseline|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
719997|NCT00163020|P2|Participant Flow|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
719998|NCT00163020|P1|Participant Flow|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
719999|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720000|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720001|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720002|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720003|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720004|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720005|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720006|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720007|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720008|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720009|NCT00163020|O2|Outcome|Triplet Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Triplet Pregnancies
720010|NCT00163020|O1|Outcome|Triplet Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Triplet Pregnancies
720011|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720012|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720013|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720014|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720015|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720016|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720017|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720018|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720019|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720020|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720021|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720022|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720023|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720024|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720025|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720026|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720027|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720028|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720029|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720030|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720031|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
720032|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
720033|NCT00163020|E2|Reported Event|Control (Castor Oil)|Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
720034|NCT00163020|E1|Reported Event|Test Group (170HP)|Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
720035|NCT00162981|B3|Baseline|Total|Total of all reporting groups
720036|NCT00162981|B2|Baseline|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
720037|NCT00162981|B1|Baseline|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
720038|NCT00162981|P2|Participant Flow|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
720039|NCT00162981|P1|Participant Flow|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
720040|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
720041|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
722592|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
720043|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
720044|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
720045|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
720046|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
720047|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
720048|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
720049|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
720050|NCT00162981|E2|Reported Event|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
720051|NCT00162981|E1|Reported Event|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
720052|NCT00162942|B3|Baseline|Total|Total of all reporting groups
720053|NCT00162942|B2|Baseline|Sham|Sham, ten apheresis sessions within 9 weeks
720054|NCT00162942|B1|Baseline|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720055|NCT00162942|P2|Participant Flow|Sham|Sham, ten apheresis sessions within 9 weeks
720056|NCT00162942|P1|Participant Flow|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720057|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720058|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720059|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720060|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720061|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720062|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720063|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720064|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720065|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720066|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720067|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720068|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720069|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720070|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720071|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720072|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720073|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720074|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720075|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720076|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720077|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720078|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720079|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720080|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720081|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720082|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720083|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720084|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720085|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720086|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720087|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720088|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720089|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720090|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720091|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720092|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720093|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720094|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720095|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720096|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720097|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720098|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720099|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720100|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720101|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
720102|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
720103|NCT00162773|B1|Baseline|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Other Names:~Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
720104|NCT00162773|P1|Participant Flow|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Other Names:~Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks"
720105|NCT00162773|O1|Outcome|All Participants|"water injection~Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Other Names:~Xolair 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.~omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
720106|NCT00162773|E1|Reported Event|All Participants|"water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE.~OR~Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE."
720107|NCT00162370|B1|Baseline|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
720108|NCT00162370|P1|Participant Flow|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
720109|NCT00162370|O1|Outcome|Definity|"All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
720110|NCT00162370|O1|Outcome|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
720111|NCT00162370|E1|Reported Event|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
720112|NCT00162266|B4|Baseline|Total|Total of all reporting groups
720113|NCT00162266|B3|Baseline|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720114|NCT00162266|B2|Baseline|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720115|NCT00162266|B1|Baseline|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720116|NCT00162266|P4|Participant Flow|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
720117|NCT00162266|P3|Participant Flow|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720118|NCT00162266|P2|Participant Flow|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720119|NCT00162266|P1|Participant Flow|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720120|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720121|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720778|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720122|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720123|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720124|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720125|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720126|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720127|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DBperiod received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately weight-tiered dose of abatacept 10 mg/kg.
720128|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720129|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720130|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720131|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720132|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720133|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720134|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720135|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720136|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720137|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720138|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720139|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720140|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg /kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720141|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720142|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720143|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720144|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720145|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720146|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720147|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720148|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720149|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720150|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720151|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720152|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720153|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720154|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720155|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720156|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720157|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720158|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720159|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720160|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720161|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720162|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
721032|NCT00159783|B4|Baseline|Total|Total of all reporting groups
720163|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720164|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720165|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720166|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720167|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720168|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720169|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720170|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720171|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720172|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720173|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720174|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720175|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720176|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720177|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720178|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720179|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720180|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720181|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720182|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720183|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720184|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720185|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720186|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720187|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720188|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720189|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by I) infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
720190|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720191|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg /kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720192|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720193|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
720194|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
720195|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
720196|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720197|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720198|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by intravenous IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720199|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720200|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720201|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720202|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720203|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720583|NCT00160563|E1|Reported Event|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
720204|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720205|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an on OL weight-tiered dose of abatacept 10 mg/kg.
720206|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720207|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720208|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720209|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720210|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720211|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720212|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720213|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DBperiod received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720214|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720215|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720216|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720217|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720218|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720219|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720220|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720584|NCT00160524|B1|Baseline|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720221|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720222|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720223|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720224|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720225|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720226|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720227|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720228|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720229|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720230|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720231|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720232|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720233|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720265|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
720234|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720235|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720236|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720237|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720238|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720239|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720240|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720241|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720242|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720243|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720244|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720245|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
720246|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720247|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720248|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720249|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720707|NCT00159965|P1|Participant Flow|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720250|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720251|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720252|NCT00162266|O4|Outcome|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
720253|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720254|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720255|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720256|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720257|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720258|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720259|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720260|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720261|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720262|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720263|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720264|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720708|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720266|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
720267|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720268|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720269|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
720270|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720271|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720272|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720273|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720274|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720275|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720276|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720277|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720278|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720279|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720307|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
720280|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720281|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720282|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720283|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720284|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720285|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720286|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720287|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720288|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720289|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720290|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720291|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720292|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720354|NCT00162123|P6|Participant Flow|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720293|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720294|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720295|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720296|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720297|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720298|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720299|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720300|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720301|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720302|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720303|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720304|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720305|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept administered monthly IV plus methotrexateParticipants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720306|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo that was administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
720308|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants received a weight-tiered dose of 10 mg/kg of abatacept, administered intravenously(IV) monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
720309|NCT00162266|E4|Reported Event|Placebo+MTX|
720310|NCT00162266|E3|Reported Event|Abatacept (LT)|
720311|NCT00162266|E2|Reported Event|Aba 2mg/kg+MTX|
720312|NCT00162266|E1|Reported Event|Aba 10mg/kg+MTX|
720313|NCT00162136|B7|Baseline|Total|Total of all reporting groups
720314|NCT00162136|B6|Baseline|45 mg/m2|Ixabepilone
720315|NCT00162136|B5|Baseline|40 mg/m2|Ixabepilone
720316|NCT00162136|B4|Baseline|35 mg/m2|Ixabepilone
720317|NCT00162136|B3|Baseline|30 mg/m2|Ixabepilone
720318|NCT00162136|B2|Baseline|20 mg/m2|Ixabepilone
720319|NCT00162136|B1|Baseline|10 mg/m2|Ixabepilone
720320|NCT00162136|P1|Participant Flow|Ixabepilone|Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
720321|NCT00162136|O1|Outcome|All Treated Participants|
720322|NCT00162136|O1|Outcome|Treated Subjects|All treated subjects with measurement at timepoint
720323|NCT00162136|O5|Outcome|Grade 4|Life-threatening or disabling
720324|NCT00162136|O4|Outcome|Grade 3|Severe
720325|NCT00162136|O3|Outcome|Grade 2|Moderate
720326|NCT00162136|O2|Outcome|Grade 1|Mild
720327|NCT00162136|O1|Outcome|Grade 0|Absent
720328|NCT00162136|O3|Outcome|All Grades|Grades 1-4
720329|NCT00162136|O2|Outcome|Grade 3/4|Grade 3=Severe, Grade 4=Life-threatening or disabling
720330|NCT00162136|O1|Outcome|Grade 1/2|Grade 1=Mild, Grade 2=Moderate
720331|NCT00162136|O6|Outcome|45 mg/m2|Ixabepilone
720332|NCT00162136|O5|Outcome|40 mg/m2|Ixabepilone
720333|NCT00162136|O4|Outcome|35 mg/m2|Ixabepilone
720334|NCT00162136|O3|Outcome|30 mg/m2|Ixabepilone
720335|NCT00162136|O2|Outcome|20 mg/m2|Ixabepilone
720336|NCT00162136|O1|Outcome|10 mg/m2|Ixabepilone
720337|NCT00162136|E6|Reported Event|Ixa 45 mg/m2|
720338|NCT00162136|E5|Reported Event|Ixa 40 mg/m2|
720339|NCT00162136|E4|Reported Event|Ixa 35 mg/m2|
720340|NCT00162136|E3|Reported Event|Ixa 30 mg/m2|
720341|NCT00162136|E2|Reported Event|Ixa 20 mg/m2|
720342|NCT00162136|E1|Reported Event|Ixa 10 mg/m2|
720343|NCT00162123|B9|Baseline|Total|Total of all reporting groups
720344|NCT00162123|B8|Baseline|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
720345|NCT00162123|B7|Baseline|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720346|NCT00162123|B6|Baseline|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720347|NCT00162123|B5|Baseline|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720348|NCT00162123|B4|Baseline|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
720349|NCT00162123|B3|Baseline|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720350|NCT00162123|B2|Baseline|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720351|NCT00162123|B1|Baseline|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720352|NCT00162123|P8|Participant Flow|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
720353|NCT00162123|P7|Participant Flow|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720585|NCT00160524|P1|Participant Flow|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720355|NCT00162123|P5|Participant Flow|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720356|NCT00162123|P4|Participant Flow|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
720357|NCT00162123|P3|Participant Flow|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720358|NCT00162123|P2|Participant Flow|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720359|NCT00162123|P1|Participant Flow|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720360|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720361|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720362|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720363|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720364|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720365|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720366|NCT00162123|O7|Outcome|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
720367|NCT00162123|O6|Outcome|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720368|NCT00162123|O5|Outcome|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720369|NCT00162123|O4|Outcome|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720398|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720370|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 0.3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720371|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720372|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720373|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720374|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720375|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720376|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720377|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720378|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720379|NCT00162123|E8|Reported Event|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
720380|NCT00162123|E7|Reported Event|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720381|NCT00162123|E6|Reported Event|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720382|NCT00162123|E5|Reported Event|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
720383|NCT00162123|E4|Reported Event|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
720384|NCT00162123|E3|Reported Event|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720490|NCT00161473|E1|Reported Event|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
720491|NCT00161382|B3|Baseline|Total|Total of all reporting groups
720385|NCT00162123|E2|Reported Event|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720386|NCT00162123|E1|Reported Event|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
720387|NCT00162097|B5|Baseline|Total|Total of all reporting groups
720388|NCT00162097|B4|Baseline|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720389|NCT00162097|B3|Baseline|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720390|NCT00162097|B2|Baseline|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720391|NCT00162097|B1|Baseline|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720392|NCT00162097|P4|Participant Flow|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720393|NCT00162097|P3|Participant Flow|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720394|NCT00162097|P2|Participant Flow|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720395|NCT00162097|P1|Participant Flow|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720396|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720397|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720492|NCT00161382|B2|Baseline|Control Group|No intervention: Control curriculum consists of standard sexual education.
720702|NCT00160199|E1|Reported Event|Prometrium 300 mg/Day|
720703|NCT00159965|B3|Baseline|Total|Total of all reporting groups
721033|NCT00159783|B3|Baseline|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
720399|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720400|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720401|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720402|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720403|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720404|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720405|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720406|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720407|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720408|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720409|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720410|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720512|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720411|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720412|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720413|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720414|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720415|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720416|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720417|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720418|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720419|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720420|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720421|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720422|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720513|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720423|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720424|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720425|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720426|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720427|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720428|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720429|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720430|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720431|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720432|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720433|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720434|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720514|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720435|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720436|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720437|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720438|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720439|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720440|NCT00162097|O5|Outcome|Participants Not Dosed|Participants were enrolled in the study and discontinued prior to study drug administration
720441|NCT00162097|O4|Outcome|Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720442|NCT00162097|O3|Outcome|Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720443|NCT00162097|O2|Outcome|Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720444|NCT00162097|O1|Outcome|Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720445|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
720446|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
720447|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
720578|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
720579|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
720448|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
720449|NCT00162097|E5|Reported Event|Not Dosed|
720450|NCT00162097|E4|Reported Event|EFV600mg Participants With Normal Hepatic Function|
720451|NCT00162097|E3|Reported Event|EFV600mg Participants With Severe Hepatic Impairment|
720452|NCT00162097|E2|Reported Event|EFV600mg Participants With Moderate Hepatic Impairment|
720453|NCT00162097|E1|Reported Event|EFV600mg Participants With Mild Hepatic Impairment|
720454|NCT00162032|B3|Baseline|Total|Total of all reporting groups
720455|NCT00162032|B2|Baseline|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
720456|NCT00162032|B1|Baseline|Children (Ages 4-11)|Arm A children 4-11 years of age
720457|NCT00162032|P2|Participant Flow|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
720458|NCT00162032|P1|Participant Flow|Children (Ages 4-11)|Arm A children 4-11 years of age
720459|NCT00162032|O4|Outcome|Adolescents (12-16 Years) Abnormal|sss (summed stress score >4, high risk
720460|NCT00162032|O3|Outcome|Children (4-11 Years) Abnormal|SSS (summed stress score)>4, high risk
720461|NCT00162032|O2|Outcome|Adolescents (12-16 Years) Normal|SSS (summed stress score) <4, low risk
720462|NCT00162032|O1|Outcome|Children (4 -11 Years) Normal|SSS (summed stress score) <=4, low risk
720463|NCT00162032|E2|Reported Event|Adolescents (Ages 12-16)|Arm B adolescents 12-16 years of age
720464|NCT00162032|E1|Reported Event|Children (Ages 4-11)|Arm A children 4-11 years of age
720465|NCT00161616|B3|Baseline|Total|Total of all reporting groups
720466|NCT00161616|B2|Baseline|Standard of Care|Standard of Care: Surgical fixation only
720467|NCT00161616|B1|Baseline|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
720468|NCT00161616|P2|Participant Flow|Standard of Care|Standard of Care: Surgical fixation only
720469|NCT00161616|P1|Participant Flow|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
720470|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
720471|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
720472|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
720473|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
720474|NCT00161616|E2|Reported Event|Standard of Care|Standard of Care: Surgical fixation only
720475|NCT00161616|E1|Reported Event|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
720476|NCT00161473|B3|Baseline|Total|Total of all reporting groups
720477|NCT00161473|B2|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
720478|NCT00161473|B1|Baseline|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
720479|NCT00161473|P2|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
720480|NCT00161473|P1|Participant Flow|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
720481|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
720482|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
720483|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
720484|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
720485|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
720486|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
720487|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
720488|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
720489|NCT00161473|E2|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
722593|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
720493|NCT00161382|B1|Baseline|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
720494|NCT00161382|P2|Participant Flow|Control Group|No intervention: Control curriculum consists of standard sexual education.
720495|NCT00161382|P1|Participant Flow|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
720496|NCT00161382|O2|Outcome|Control Group|No intervention: Control curriculum consists of standard sexual education.
720497|NCT00161382|O1|Outcome|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
720498|NCT00161382|E2|Reported Event|Control Group|No intervention: Control curriculum consists of standard sexual education.
720499|NCT00161382|E1|Reported Event|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
720500|NCT00161213|B1|Baseline|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
720501|NCT00161213|P1|Participant Flow|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
720502|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
720503|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
720504|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
720505|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
720506|NCT00161213|E1|Reported Event|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
720507|NCT00160706|B1|Baseline|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720508|NCT00160706|P1|Participant Flow|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720509|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720510|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720511|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
722594|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
720515|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720516|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720517|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720518|NCT00160706|E1|Reported Event|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
720519|NCT00160693|B1|Baseline|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720520|NCT00160693|P1|Participant Flow|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720521|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720522|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720523|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720524|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720525|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720526|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720527|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720528|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720529|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720530|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720531|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720532|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720533|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720534|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720535|NCT00160693|E1|Reported Event|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
720536|NCT00160641|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720537|NCT00160641|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720538|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720539|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720540|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720541|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720580|NCT00160563|E4|Reported Event|PLC-LCTZ|Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
720581|NCT00160563|E3|Reported Event|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
720582|NCT00160563|E2|Reported Event|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
720542|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720543|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720544|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720545|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720546|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720547|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720548|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720549|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720550|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720551|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720552|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720553|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720554|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720555|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720556|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720557|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720558|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720559|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720560|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720561|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720562|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720563|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720564|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720565|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720566|NCT00160641|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
720567|NCT00160563|B4|Baseline|Total|Total of all reporting groups
720568|NCT00160563|B3|Baseline|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
720569|NCT00160563|B2|Baseline|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
720570|NCT00160563|B1|Baseline|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
720571|NCT00160563|P3|Participant Flow|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
720572|NCT00160563|P2|Participant Flow|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
720573|NCT00160563|P1|Participant Flow|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
720574|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
720575|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
720576|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
720577|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
720586|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720587|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720588|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720589|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720590|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720591|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720592|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720593|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720594|NCT00160524|E1|Reported Event|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
720595|NCT00160251|B7|Baseline|Total|Total of all reporting groups
720596|NCT00160251|B6|Baseline|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720597|NCT00160251|B5|Baseline|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720598|NCT00160251|B4|Baseline|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720599|NCT00160251|B3|Baseline|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720600|NCT00160251|B2|Baseline|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720601|NCT00160251|B1|Baseline|Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
720602|NCT00160251|P8|Participant Flow|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
720603|NCT00160251|P7|Participant Flow|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720604|NCT00160251|P6|Participant Flow|ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720605|NCT00160251|P5|Participant Flow|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720606|NCT00160251|P4|Participant Flow|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720607|NCT00160251|P3|Participant Flow|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720608|NCT00160251|P2|Participant Flow|Arm 1B: PEG + RBV + BOC|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720609|NCT00160251|P1|Participant Flow|Arm 1A: PEG + RBV|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720610|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720704|NCT00159965|B2|Baseline|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720611|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720612|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720613|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720614|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720615|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720616|NCT00160251|O8|Outcome|Missing Data|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720617|NCT00160251|O7|Outcome|Log Drop ≥5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720618|NCT00160251|O6|Outcome|Log Drop 4 to <5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720619|NCT00160251|O5|Outcome|Log Drop 3 to <4|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720620|NCT00160251|O4|Outcome|Log Drop 2 to <3|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720621|NCT00160251|O3|Outcome|Log Drop 1 to <2|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720622|NCT00160251|O2|Outcome|Log Drop 0 to <1|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720623|NCT00160251|O1|Outcome|Log Drop <0|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
720624|NCT00160251|O5|Outcome|Log Drop ≥5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
720625|NCT00160251|O4|Outcome|Log Drop 4 to <5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
720626|NCT00160251|O3|Outcome|Log Drop 3 to <4|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
720627|NCT00160251|O2|Outcome|Log Drop 2 to <3|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
720628|NCT00160251|O1|Outcome|Log Drop 1 to <2|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
720629|NCT00160251|O6|Outcome|Log Drop ≥5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
720630|NCT00160251|O5|Outcome|Log Drop 4 to <5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
720631|NCT00160251|O4|Outcome|Log Drop 3 to <4|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
720632|NCT00160251|O3|Outcome|Log Drop 2 to <3|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
720633|NCT00160251|O2|Outcome|Log Drop 1 to <2|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
720777|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720634|NCT00160251|O1|Outcome|Log Drop 0 to <1|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
720635|NCT00160251|O8|Outcome|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
720636|NCT00160251|O7|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720637|NCT00160251|O6|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720638|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720639|NCT00160251|O4|Outcome|Arm 3: PEG + BOC 200|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720640|NCT00160251|O3|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720641|NCT00160251|O2|Outcome|Arm 1B: PEG + RBV + BOC 400|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720642|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
720643|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720644|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720645|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720646|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720647|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720648|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720649|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720650|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720651|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720652|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720653|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720654|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720655|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720656|NCT00160251|O5|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720657|NCT00160251|O4|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720658|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720659|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720705|NCT00159965|B1|Baseline|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720706|NCT00159965|P2|Participant Flow|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
722595|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
720660|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
720661|NCT00160251|O3|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720662|NCT00160251|O2|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720663|NCT00160251|O1|Outcome|Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400|A single dose of PEG was given first, followed 1 week later by PEG + BOC. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720664|NCT00160251|O4|Outcome|>12 to 36 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 12 to 36.
720665|NCT00160251|O3|Outcome|>8 to 12 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 8 to 12.
720666|NCT00160251|O2|Outcome|>4 to 8 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 4 to 8.
720667|NCT00160251|O1|Outcome|0 to ≤ 4 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA within the first 4 weeks of treatment.
720668|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720669|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720670|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720671|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720672|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720673|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720674|NCT00160251|E8|Reported Event|PEG + RBV + BOC 800|Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
720675|NCT00160251|E7|Reported Event|PEG + BOC 800 (24 Weeks)|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720676|NCT00160251|E6|Reported Event|PEG + BOC 400 (24 + 48 Weeks)|Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720677|NCT00160251|E5|Reported Event|PEG + RBV + BOC 400 (48 Weeks)|Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720678|NCT00160251|E4|Reported Event|PEG + BOC 200 (48 Weeks)|Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720679|NCT00160251|E3|Reported Event|PEG + BOC 100 (48 Weeks)|Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720680|NCT00160251|E2|Reported Event|PEG + RBV + BOC 400 (24 Weeks)|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
720681|NCT00160251|E1|Reported Event|PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
720682|NCT00160199|B3|Baseline|Total|Total of all reporting groups
720683|NCT00160199|B2|Baseline|Prometrium 400 mg/Day|
720684|NCT00160199|B1|Baseline|Prometrium 300 mg/Day|
720685|NCT00160199|P2|Participant Flow|Prometrium 400 mg/Day|
720686|NCT00160199|P1|Participant Flow|Prometrium 300 mg/Day|
720687|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
720688|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
720689|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
720690|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
720691|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
720692|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
720693|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
720694|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
720695|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
720696|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
720697|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
720698|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
720699|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
720700|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
720701|NCT00160199|E2|Reported Event|Prometrium 400 mg/Day|
720709|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720710|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720711|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720712|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720713|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720714|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720715|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720716|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720717|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720718|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720719|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720720|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720721|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720722|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720723|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720724|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720725|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720726|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720727|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720728|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720729|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720730|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720731|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720732|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720733|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720734|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720735|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720736|NCT00159965|E2|Reported Event|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720737|NCT00159965|E1|Reported Event|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
720738|NCT00159913|B5|Baseline|Total|Total of all reporting groups
720739|NCT00159913|B4|Baseline|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720740|NCT00159913|B3|Baseline|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720741|NCT00159913|B2|Baseline|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720742|NCT00159913|B1|Baseline|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720743|NCT00159913|P4|Participant Flow|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720744|NCT00159913|P3|Participant Flow|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720745|NCT00159913|P2|Participant Flow|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
722370|NCT00151892|P2|Participant Flow|Asacol|1.6g/day administered 800 mg twice daily (BID)
720746|NCT00159913|P1|Participant Flow|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720747|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720748|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720749|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720750|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720751|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720752|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720753|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720754|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720755|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720756|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720757|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720758|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720759|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720760|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720761|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720762|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720763|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720764|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720765|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720766|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720767|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720768|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720769|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720770|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720771|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720772|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720773|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720774|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720775|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720776|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
722371|NCT00151892|P1|Participant Flow|SPD476|2.4 g/day once daily (QD)
720779|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720780|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720781|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720782|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720783|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720784|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720785|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720786|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720787|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720788|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720789|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720790|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720791|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720792|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720793|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720794|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720795|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720796|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720797|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720798|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720799|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720800|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720801|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720802|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720803|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720804|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720805|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720806|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720807|NCT00159913|E5|Reported Event|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
720808|NCT00159913|E4|Reported Event|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
720809|NCT00159913|E3|Reported Event|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
720810|NCT00159913|E2|Reported Event|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
721264|NCT00158223|E1|Reported Event|Placebo|Participants received encapsulated placebo made to match active drug
720811|NCT00159913|E1|Reported Event|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
720812|NCT00159874|B8|Baseline|Total|Total of all reporting groups
720813|NCT00159874|B7|Baseline|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720814|NCT00159874|B6|Baseline|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720815|NCT00159874|B5|Baseline|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720816|NCT00159874|B4|Baseline|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720817|NCT00159874|B3|Baseline|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720818|NCT00159874|B2|Baseline|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720819|NCT00159874|B1|Baseline|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720820|NCT00159874|P7|Participant Flow|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720821|NCT00159874|P6|Participant Flow|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720822|NCT00159874|P5|Participant Flow|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720823|NCT00159874|P4|Participant Flow|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720824|NCT00159874|P3|Participant Flow|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720825|NCT00159874|P2|Participant Flow|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720826|NCT00159874|P1|Participant Flow|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720827|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720828|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720829|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720830|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720831|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720832|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720833|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720834|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720835|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720836|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720837|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720838|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720839|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720840|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720841|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720842|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720843|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720844|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720845|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720846|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720847|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720848|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720849|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720850|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720851|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720852|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720853|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720854|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720855|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720856|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720857|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720858|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720859|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720860|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720861|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720862|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720863|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720864|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720865|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720866|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720867|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720868|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720869|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
721265|NCT00158197|B5|Baseline|Total|Total of all reporting groups
720870|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720871|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720872|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720873|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720874|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720875|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720876|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720877|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720878|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720879|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720880|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720881|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720882|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720883|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720884|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720885|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720886|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720887|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720888|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720889|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720890|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720891|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720892|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720893|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720894|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720895|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720896|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720897|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720898|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720899|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
722372|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
720900|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720901|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720902|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720903|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720904|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720905|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720906|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720907|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720908|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720909|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720910|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720911|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720912|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720913|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720914|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720915|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720916|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720917|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720918|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720919|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720920|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720921|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720922|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720923|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720924|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720925|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720926|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720927|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720928|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720929|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720930|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720931|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720932|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720933|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720934|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720935|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720936|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720937|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720938|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720939|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720940|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720941|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720942|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720943|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720944|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720945|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720946|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720947|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720948|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720949|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720950|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720951|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720952|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720953|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720954|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720955|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720956|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720957|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720958|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720959|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720960|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720961|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720962|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720963|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720964|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720965|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
722373|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
720966|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720967|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720968|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720969|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720970|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720971|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720972|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720973|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720974|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720975|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720976|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720977|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720978|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720979|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720980|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720981|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720982|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720983|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
720984|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
720985|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
720986|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
720987|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
720988|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
720989|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
720990|NCT00159874|E3|Reported Event|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
720991|NCT00159874|E2|Reported Event|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
720992|NCT00159874|E1|Reported Event|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
720993|NCT00159861|B3|Baseline|Total|Total of all reporting groups
720994|NCT00159861|B2|Baseline|Sildenafil/Sildenafil|Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
720995|NCT00159861|B1|Baseline|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
720996|NCT00159861|P2|Participant Flow|Sildenafil: Core Study / Sildenafil: Extension Study|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
720997|NCT00159861|P1|Participant Flow|Placebo: Core Study / Sildenafil: Extension Study|Core Study: Placebo (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration); Extension Study: Sildenafil (until last enrolled subject completed 3 years of treatment) - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
722374|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
720998|NCT00159861|O2|Outcome|Sldenafil/Sildenafil|Core Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
720999|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study A1481141: Placebo TID (3 times daily); Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721000|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721001|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721002|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721003|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721004|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721005|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721006|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721007|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721008|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721009|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721010|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721011|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721012|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator.
721013|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721014|NCT00159861|E3|Reported Event|Placebo/Discontinued|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Discontinued
721015|NCT00159861|E2|Reported Event|Sildenafil/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721016|NCT00159861|E1|Reported Event|Placebo/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
721017|NCT00159822|B1|Baseline|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721018|NCT00159822|P1|Participant Flow|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721019|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721034|NCT00159783|B2|Baseline|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721020|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721021|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721022|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721023|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721024|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721025|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721026|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721027|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721028|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721029|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721030|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721031|NCT00159822|E1|Reported Event|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
721035|NCT00159783|B1|Baseline|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721036|NCT00159783|P3|Participant Flow|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721037|NCT00159783|P2|Participant Flow|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721038|NCT00159783|P1|Participant Flow|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721039|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721040|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721041|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721042|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721043|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721044|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721045|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721046|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721047|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721048|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721049|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721050|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721051|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721052|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721053|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721054|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721055|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721056|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721057|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721058|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721059|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721060|NCT00159783|O1|Outcome|All Treatment Groups|Asenapine 5-10 mg twice daily for 40 weeks or Olanzapine 5-20 mg daily for 40 weeks
721061|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721062|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721063|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721064|NCT00159783|E3|Reported Event|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
721065|NCT00159783|E2|Reported Event|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
721066|NCT00159783|E1|Reported Event|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
721067|NCT00159432|B1|Baseline|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
721068|NCT00159432|P1|Participant Flow|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
721069|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
721070|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
721071|NCT00159432|E1|Reported Event|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
721072|NCT00159419|B3|Baseline|Total|Total of all reporting groups
721073|NCT00159419|B2|Baseline|Alendronate Treatment|
721074|NCT00159419|B1|Baseline|Pamidronate Treatment|
721075|NCT00159419|P2|Participant Flow|Alendronate Treatment|
721076|NCT00159419|P1|Participant Flow|Pamidronate Treatment|
721077|NCT00159419|O2|Outcome|Alendronate|
721078|NCT00159419|O1|Outcome|Pamidronate Treatment|
721079|NCT00159419|E2|Reported Event|Alendronate Treatment|
721080|NCT00159419|E1|Reported Event|Pamidronate Treatment|Acute phase reaction with infusion
721081|NCT00158925|B1|Baseline|EASYTRAK EPI Lead|"Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.~EASYTRAK EPI lead: EASYTRAK EPI lead"
721082|NCT00158925|P1|Participant Flow|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
721083|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
721084|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
721085|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
721258|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
721086|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
721087|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
721088|NCT00158925|E1|Reported Event|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
721089|NCT00158756|B6|Baseline|Total|Total of all reporting groups
721090|NCT00158756|B5|Baseline|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721091|NCT00158756|B4|Baseline|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721092|NCT00158756|B3|Baseline|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721093|NCT00158756|B2|Baseline|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721094|NCT00158756|B1|Baseline|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721095|NCT00158756|P5|Participant Flow|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721096|NCT00158756|P4|Participant Flow|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721097|NCT00158756|P3|Participant Flow|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721098|NCT00158756|P2|Participant Flow|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721099|NCT00158756|P1|Participant Flow|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721100|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721101|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721102|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721103|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721104|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721105|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721106|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721107|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721108|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721109|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721110|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721111|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721112|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721113|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721114|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721115|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721116|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721117|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721118|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721119|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721120|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721121|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721122|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721123|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721124|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721125|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721126|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721127|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721128|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721129|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721130|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721131|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721132|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721133|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721134|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721135|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721136|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721137|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721138|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721139|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721259|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
721140|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721141|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721142|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721143|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721144|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721145|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721146|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721147|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721148|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721149|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721150|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721151|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721152|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721153|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721154|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721155|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721156|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721157|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721158|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721159|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721160|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721161|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721162|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721163|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721164|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721165|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721260|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
721166|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721167|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721168|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721169|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721170|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721171|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721172|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721173|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721174|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721175|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721176|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721177|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721178|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721179|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721180|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721181|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721182|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721183|NCT00158756|O5|Outcome|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721184|NCT00158756|O4|Outcome|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721185|NCT00158756|O3|Outcome|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721186|NCT00158756|O2|Outcome|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721187|NCT00158756|O1|Outcome|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721188|NCT00158756|E5|Reported Event|Triple Antigen™+Engerix™-B Group|Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
721189|NCT00158756|E4|Reported Event|Zilbrix™+Placebo Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721190|NCT00158756|E3|Reported Event|Zilbrix™+Rotarix™ Group|Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721191|NCT00158756|E2|Reported Event|Tritanrix™-HepB+Placebo Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
721261|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
721192|NCT00158756|E1|Reported Event|Tritanrix™-HepB+Rotarix™ Group|Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
721193|NCT00158743|B3|Baseline|Total|Total of all reporting groups
721194|NCT00158743|B2|Baseline|Placebo|sodium chloride placebo
721195|NCT00158743|B1|Baseline|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
721196|NCT00158743|P2|Participant Flow|Placebo|sodium chloride placebo
721197|NCT00158743|P1|Participant Flow|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
721198|NCT00158743|O2|Outcome|Placebo|sodium chloride placebo
721199|NCT00158743|O1|Outcome|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
721200|NCT00158743|E2|Reported Event|Placebo|sodium chloride placebo
721201|NCT00158743|E1|Reported Event|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
721202|NCT00158600|B3|Baseline|Total|Total of all reporting groups
721203|NCT00158600|B2|Baseline|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721204|NCT00158600|B1|Baseline|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721205|NCT00158600|P2|Participant Flow|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721206|NCT00158600|P1|Participant Flow|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721207|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721208|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721209|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721210|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721211|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721212|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721213|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721214|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721215|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721216|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721217|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721218|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721219|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721220|NCT00158600|E3|Reported Event|Overall|
721221|NCT00158600|E2|Reported Event|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
721222|NCT00158600|E1|Reported Event|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
721223|NCT00158379|B1|Baseline|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
721224|NCT00158379|P1|Participant Flow|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
721225|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
721226|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
721227|NCT00158379|E1|Reported Event|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
721228|NCT00158262|B3|Baseline|Total|Total of all reporting groups
721229|NCT00158262|B2|Baseline|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721230|NCT00158262|B1|Baseline|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721262|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
721263|NCT00158223|E2|Reported Event|Pimozide|Participants received pimozide flexible dosing
722375|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
721231|NCT00158262|P2|Participant Flow|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721232|NCT00158262|P1|Participant Flow|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721233|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721234|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721235|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721236|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721237|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721238|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721239|NCT00158262|E2|Reported Event|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721240|NCT00158262|E1|Reported Event|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
721241|NCT00158249|B3|Baseline|Total|Total of all reporting groups
721242|NCT00158249|B2|Baseline|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
721243|NCT00158249|B1|Baseline|Placebo|"matched capsules~placebo: matched for physical appearance"
721244|NCT00158249|P2|Participant Flow|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
721245|NCT00158249|P1|Participant Flow|Placebo|"matched capsules~placebo: matched for physical appearance"
721246|NCT00158249|O2|Outcome|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
721247|NCT00158249|O1|Outcome|Placebo|"matched capsules~placebo: matched for physical appearance"
721248|NCT00158249|O2|Outcome|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
721249|NCT00158249|O1|Outcome|Placebo|"matched capsules~placebo: matched for physical appearance"
721250|NCT00158249|E2|Reported Event|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
721251|NCT00158249|E1|Reported Event|Placebo|"matched capsules~placebo: matched for physical appearance"
721252|NCT00158223|B3|Baseline|Total|Total of all reporting groups
721253|NCT00158223|B2|Baseline|Pimozide|Participants received pimozide flexible dosing
721254|NCT00158223|B1|Baseline|Placebo|Participants received encapsulated placebo made to match active drug
721255|NCT00158223|P2|Participant Flow|Pimozide|Participants received pimozide flexible dosing
721256|NCT00158223|P1|Participant Flow|Placebo|Participants received encapsulated placebo made to match active drug
721257|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
722376|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
721266|NCT00158197|B4|Baseline|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
721267|NCT00158197|B3|Baseline|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721268|NCT00158197|B2|Baseline|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721269|NCT00158197|B1|Baseline|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721270|NCT00158197|P4|Participant Flow|Standard|Participants assigned to the standard condition did not receive vouchers for the provision of clean urines.
721271|NCT00158197|P3|Participant Flow|Intermittent Unpredictable Schedule|"Participants in the unpredictable intermittent condition earned vouchers of the same magnitude as those in the predictable intermittent condition and at approximately the same rate (i.e., $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second week of methamphetamine-negative urines, etc). More specifically, participants in this group received a voucher for $22.00 following their first three methamphetamine-negative urine tests. Following that they were eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. This date was randomly determined and they did not know in advance what day it was.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721272|NCT00158197|P2|Participant Flow|Continuous Schedule|"Those in the continuous condition received a voucher each time they tested negative for methamphetamine. The initial voucher value was $2.50. Each consecutive instance of abstinence increased the magnitude of the voucher by $1.50. Three consecutive abstinences resulted in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression could begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721273|NCT00158197|P1|Participant Flow|Intermittent Predictable Schedule|"Those in the intermittent predictable condition earned a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition received $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There were no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721274|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
721275|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721286|NCT00158197|E4|Reported Event|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
721346|NCT00157820|E3|Reported Event|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
721347|NCT00157820|E2|Reported Event|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated
721348|NCT00157820|E1|Reported Event|SC True|Allocated to Single Chamber ICD (SC true arm)
721276|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721277|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721278|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
721279|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721280|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721281|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721282|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
721283|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721284|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721285|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
721341|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
721287|NCT00158197|E3|Reported Event|Intermittent Unpredictable Schedule|Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week. Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests. They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test. All participants will provide observed urine samples M, W, & F for 12 wks and complete measures 1x/wk.
721288|NCT00158197|E2|Reported Event|Intermittent Predictable Schedule|Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
721289|NCT00158197|E1|Reported Event|Continuous Voucher Schedule|Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
721290|NCT00158184|B3|Baseline|Total|Total of all reporting groups
721291|NCT00158184|B2|Baseline|Rx Opioid Medical Users|Prescription Opioids users without abusive patterns of use.
721292|NCT00158184|B1|Baseline|Rx Opioid Abusers|Prescription Opioids users with abusive patterns of use.
721293|NCT00158184|P2|Participant Flow|Rx Opioid Non-Abusers|The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of participants with no history of opioid abuse.
721294|NCT00158184|P1|Participant Flow|Rx Opioid Abusers|The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of recreational prescription opioid (Rx) users.
721295|NCT00158184|O2|Outcome|Rx Opioid Non-Abusers|Medical users
721296|NCT00158184|O1|Outcome|Rx Opioid Abusers|Recreation users
721297|NCT00158184|O2|Outcome|Rx Opioid Non-Abusers|Medical prescription opioid users.
721298|NCT00158184|O1|Outcome|Rx Opioid Abusers|Recreational prescription opioid users.
721299|NCT00158184|E2|Reported Event|Rx Opioid Non-Abusers|
721300|NCT00158184|E1|Reported Event|Rx Opioid Abusers|
721301|NCT00158054|B3|Baseline|Total|Total of all reporting groups
721302|NCT00158054|B2|Baseline|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
721303|NCT00158054|B1|Baseline|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
721304|NCT00158054|P2|Participant Flow|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
721305|NCT00158054|P1|Participant Flow|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
721306|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
721307|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
721342|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
721343|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm"
721344|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
721308|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
721309|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
721310|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
721311|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
721312|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
721313|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
721314|NCT00158054|E2|Reported Event|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
721315|NCT00158054|E1|Reported Event|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
721316|NCT00157950|B3|Baseline|Total|Total of all reporting groups
721317|NCT00157950|B2|Baseline|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721318|NCT00157950|B1|Baseline|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721319|NCT00157950|P2|Participant Flow|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721320|NCT00157950|P1|Participant Flow|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721321|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721322|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721323|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721324|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721325|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721326|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721327|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721328|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721329|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721330|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721331|NCT00157950|E2|Reported Event|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
721332|NCT00157950|E1|Reported Event|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
721333|NCT00157820|B4|Baseline|Total|Total of all reporting groups
721334|NCT00157820|B3|Baseline|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
721335|NCT00157820|B2|Baseline|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
721336|NCT00157820|B1|Baseline|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
721337|NCT00157820|P3|Participant Flow|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
721338|NCT00157820|P2|Participant Flow|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
721339|NCT00157820|P1|Participant Flow|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
721340|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
721350|NCT00157755|B2|Baseline|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721351|NCT00157755|B1|Baseline|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721352|NCT00157755|P6|Participant Flow|Idiopathic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.
721353|NCT00157755|P5|Participant Flow|Idiopathic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
721354|NCT00157755|P4|Participant Flow|Idiopathic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
721355|NCT00157755|P3|Participant Flow|Diabetic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.
721356|NCT00157755|P2|Participant Flow|Diabetic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
721357|NCT00157755|P1|Participant Flow|Diabetic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
721358|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721359|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721360|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721361|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721362|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721363|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721364|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721365|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721366|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721367|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721368|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721369|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721370|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721371|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721372|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721373|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721374|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721375|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721376|NCT00157755|E2|Reported Event|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
721377|NCT00157755|E1|Reported Event|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
721378|NCT00157573|B1|Baseline|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
721379|NCT00157573|P2|Participant Flow|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and the white blood cell count.
721380|NCT00157573|P1|Participant Flow|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
721381|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
721417|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721418|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721419|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721382|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
721383|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
721384|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
721385|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
721386|NCT00157573|E2|Reported Event|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count.
721387|NCT00157573|E1|Reported Event|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
721388|NCT00157248|B5|Baseline|Total|Total of all reporting groups
721389|NCT00157248|B4|Baseline|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
721390|NCT00157248|B3|Baseline|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
721391|NCT00157248|B2|Baseline|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
721392|NCT00157248|B1|Baseline|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
721393|NCT00157248|P4|Participant Flow|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
721394|NCT00157248|P3|Participant Flow|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
721395|NCT00157248|P2|Participant Flow|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
721396|NCT00157248|P1|Participant Flow|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
721397|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721398|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721399|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721400|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721401|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721402|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721403|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721404|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721405|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721406|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721407|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721408|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721409|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721410|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721411|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721412|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721413|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721414|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721415|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721416|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721535|NCT00157157|O2|Outcome|PUPs -Termination Visit|Incremental recovery at the Termination Study Visit
721420|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721421|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721422|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721423|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721424|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721425|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721426|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721427|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721428|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721429|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721430|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721431|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721432|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721433|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721434|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721435|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721436|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721437|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721438|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721439|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721440|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721441|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721442|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721443|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721444|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721445|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721446|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721447|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721448|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721449|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721450|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721451|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721452|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721453|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721454|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721455|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721456|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721457|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721458|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721459|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721460|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721461|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721462|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721463|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721464|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721465|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721466|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721467|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721468|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721469|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721470|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721471|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721472|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721473|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721474|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721475|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721476|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721477|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721478|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721479|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721480|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721481|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721482|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721483|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721484|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721485|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721486|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721487|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721488|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721489|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721490|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721491|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721492|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721493|NCT00157248|E6|Reported Event|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
721494|NCT00157248|E5|Reported Event|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
721495|NCT00157248|E4|Reported Event|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
721496|NCT00157248|E3|Reported Event|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
721497|NCT00157248|E2|Reported Event|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
721498|NCT00157248|E1|Reported Event|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
721499|NCT00157209|B3|Baseline|Total|Total of all reporting groups
721500|NCT00157209|B2|Baseline|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721501|NCT00157209|B1|Baseline|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721502|NCT00157209|P2|Participant Flow|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721503|NCT00157209|P1|Participant Flow|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
722377|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
721504|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721505|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721506|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721507|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721508|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721509|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721510|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721511|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721512|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721513|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721514|NCT00157209|E2|Reported Event|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721536|NCT00157157|O1|Outcome|PUPs -Initial Visit|Incremental recovery at the Initial Study Visit
721537|NCT00157157|O3|Outcome|PUPs -During Perioperative Management|rAHF-PFM was administered intravenously via bolus infusion, or continuous infusion. The dosing regimen used was at the discretion of the investigator and in accordance with the institution’s standard of care.
721515|NCT00157209|E1|Reported Event|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
721516|NCT00157196|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
721517|NCT00157196|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
721518|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
721519|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
721520|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
721521|NCT00157196|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
721522|NCT00157157|B1|Baseline|PUPs|
721523|NCT00157157|P1|Participant Flow|Previously Untreated Patients (PUPs)|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). The dosing regimen used to treat bleeding episodes (BEs) was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episodes diagnosed.
721524|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
721525|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
721526|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
721527|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
721528|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
721529|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
721530|NCT00157157|O1|Outcome|PUPs|
721531|NCT00157157|O1|Outcome|PUPs|
721532|NCT00157157|O1|Outcome|PUPs|
721533|NCT00157157|O1|Outcome|PUPs|
721534|NCT00157157|O1|Outcome|PUPs|
721538|NCT00157157|O2|Outcome|PUPs -During On-Demand Treatment|The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of BE diagnosed.
721539|NCT00157157|O1|Outcome|PUPs -During Prophylaxis|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator]. The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episode (BE) diagnosed.
721540|NCT00157157|O1|Outcome|PUPs|
721541|NCT00157157|O1|Outcome|PUPs|
721542|NCT00157157|O1|Outcome|PUPs|
721543|NCT00157157|O1|Outcome|PUPs|
721544|NCT00157157|E1|Reported Event|PUPs|
721545|NCT00157014|B5|Baseline|Total|Total of all reporting groups
721546|NCT00157014|B4|Baseline|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721547|NCT00157014|B3|Baseline|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721548|NCT00157014|B2|Baseline|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721549|NCT00157014|B1|Baseline|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721550|NCT00157014|P4|Participant Flow|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721551|NCT00157014|P3|Participant Flow|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721552|NCT00157014|P2|Participant Flow|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721553|NCT00157014|P1|Participant Flow|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721554|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721555|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721556|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721557|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721558|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721559|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721560|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721561|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721562|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721563|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721564|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721565|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721566|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721567|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721568|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721569|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721570|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721571|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721572|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721573|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721574|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721575|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721576|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721577|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721578|NCT00157014|O2|Outcome|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721579|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721580|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721581|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721582|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721583|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721584|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721585|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721586|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721587|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721588|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721589|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721590|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721591|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721592|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721593|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721594|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721595|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721596|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721597|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721598|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721599|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721600|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721601|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721602|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721603|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721604|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721605|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721606|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721607|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721608|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721609|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721610|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721611|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721612|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721613|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721614|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721615|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721616|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721617|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721618|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721619|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721620|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721621|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721622|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721623|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721624|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721625|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721626|NCT00157014|E4|Reported Event|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721627|NCT00157014|E3|Reported Event|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
721628|NCT00157014|E2|Reported Event|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721629|NCT00157014|E1|Reported Event|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
721630|NCT00156936|B3|Baseline|Total|Total of all reporting groups
721631|NCT00156936|B2|Baseline|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
722378|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
721632|NCT00156936|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
721633|NCT00156936|P2|Participant Flow|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
721634|NCT00156936|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
721635|NCT00156936|O2|Outcome|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
721636|NCT00156936|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
721637|NCT00156936|E2|Reported Event|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
721638|NCT00156936|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
721639|NCT00156923|B3|Baseline|Total|Total of all reporting groups
721640|NCT00156923|B2|Baseline|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
721641|NCT00156923|B1|Baseline|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
721642|NCT00156923|P2|Participant Flow|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
721643|NCT00156923|P1|Participant Flow|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
721644|NCT00156923|O2|Outcome|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
721645|NCT00156923|O1|Outcome|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
721646|NCT00156923|E2|Reported Event|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
721647|NCT00156923|E1|Reported Event|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
721648|NCT00156910|B3|Baseline|Total|Total of all reporting groups
721649|NCT00156910|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721650|NCT00156910|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721651|NCT00156910|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721652|NCT00156910|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721653|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721654|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721655|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721656|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721657|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721658|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721659|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721660|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721661|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721662|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721663|NCT00156910|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
721664|NCT00156910|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
721665|NCT00156819|B4|Baseline|Total|Total of all reporting groups
721666|NCT00156819|B3|Baseline|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721667|NCT00156819|B2|Baseline|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721668|NCT00156819|B1|Baseline|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721669|NCT00156819|P3|Participant Flow|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721670|NCT00156819|P2|Participant Flow|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721671|NCT00156819|P1|Participant Flow|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721672|NCT00156819|O3|Outcome|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721673|NCT00156819|O2|Outcome|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721674|NCT00156819|O1|Outcome|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721675|NCT00156819|E3|Reported Event|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721676|NCT00156819|E2|Reported Event|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721677|NCT00156819|E1|Reported Event|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
721678|NCT00156715|B1|Baseline|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
721679|NCT00156715|P1|Participant Flow|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
721680|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
721725|NCT00156065|P3|Participant Flow|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
721726|NCT00156065|P2|Participant Flow|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
722023|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
721681|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
721682|NCT00156715|E1|Reported Event|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
721683|NCT00156533|B5|Baseline|Total|Total of all reporting groups
721684|NCT00156533|B4|Baseline|CTRL|Monitor only condition.
721685|NCT00156533|B3|Baseline|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
721686|NCT00156533|B2|Baseline|QHS Zolpidem|QHS dosing with 10mg of zolpidem
721687|NCT00156533|B1|Baseline|Placebo|QHS dosing with placebo
721688|NCT00156533|P4|Participant Flow|CTRL|Monitor only condition.
721689|NCT00156533|P3|Participant Flow|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
721690|NCT00156533|P2|Participant Flow|QHS (Nightly) Zolpidem|Once nightly (QHS) dosing with 10mg of zolpidem
721691|NCT00156533|P1|Participant Flow|Placebo|Once nightly dosing (quaque hora somni [QHS])with placebo
721692|NCT00156533|O4|Outcome|CTRL|Monitor only condition.
721693|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
721694|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
721695|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
721696|NCT00156533|O4|Outcome|CTRL|Monitor only condition (no placebo and no zolpidem).
721697|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
721698|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
721699|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
721700|NCT00156533|E4|Reported Event|CTRL|Monitor only condition.
721701|NCT00156533|E3|Reported Event|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
721702|NCT00156533|E2|Reported Event|QHS Zolpidem|QHS dosing with 10mg of zolpidem
721703|NCT00156533|E1|Reported Event|Placebo|QHS dosing with placebo
721704|NCT00156390|B3|Baseline|Total|Total of all reporting groups
721705|NCT00156390|B2|Baseline|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
721706|NCT00156390|B1|Baseline|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
721707|NCT00156390|P2|Participant Flow|LV Lead Placement as Per Standard of Care (Without Echo-guida|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
721708|NCT00156390|P1|Participant Flow|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
721709|NCT00156390|O2|Outcome|LV Lead Placement as Per Standard of Care (Without Echo-guida|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
721710|NCT00156390|O1|Outcome|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
721711|NCT00156390|O2|Outcome|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
721712|NCT00156390|O1|Outcome|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
721713|NCT00156390|E2|Reported Event|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
721714|NCT00156390|E1|Reported Event|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
721715|NCT00156247|B1|Baseline|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
721716|NCT00156247|P1|Participant Flow|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
721717|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
721718|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
721719|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
721720|NCT00156247|E1|Reported Event|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
721721|NCT00156065|B4|Baseline|Total|Total of all reporting groups
721722|NCT00156065|B3|Baseline|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
721723|NCT00156065|B2|Baseline|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
721724|NCT00156065|B1|Baseline|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
721727|NCT00156065|P1|Participant Flow|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
721728|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
721729|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
721730|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
721731|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
721732|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
721733|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
721734|NCT00156065|E3|Reported Event|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
721735|NCT00156065|E2|Reported Event|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
721736|NCT00156065|E1|Reported Event|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
721737|NCT00156013|B1|Baseline|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
721738|NCT00156013|P1|Participant Flow|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
721739|NCT00156013|O1|Outcome|Toxicity|Myelosuppresion
721740|NCT00156013|O1|Outcome|Open Label Trial of Clofarabine in Relapsed or Refractory NHL|"Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.~CLOFARABINE: 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles"
721741|NCT00156013|O1|Outcome|Clofarabine|During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
721742|NCT00156013|E1|Reported Event|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
721743|NCT00154466|B4|Baseline|Total|Total of all reporting groups
721744|NCT00154466|B3|Baseline|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721745|NCT00154466|B2|Baseline|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721746|NCT00154466|B1|Baseline|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721747|NCT00154466|P3|Participant Flow|Healthy Controls|For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.
721748|NCT00154466|P2|Participant Flow|Post-infarction Nontraining|in which patients continued their usual lifestyle.
721749|NCT00154466|P1|Participant Flow|Post-infarction Training|which underwent a 3-month cardiac rehabilitation program
721750|NCT00154466|O3|Outcome|Healthy Controls|19 age- and sex-matched healthy volunteers
721751|NCT00154466|O2|Outcome|Post-infarction Nontraining|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721752|NCT00154466|O1|Outcome|Post-infarction Training|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721753|NCT00154466|O2|Outcome|Post-infarction Nontraining|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
721754|NCT00154466|O1|Outcome|Post-infarction Training|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
721755|NCT00154466|E3|Reported Event|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721756|NCT00154466|E2|Reported Event|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721757|NCT00154466|E1|Reported Event|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
721758|NCT00154375|B3|Baseline|Total|Total of all reporting groups
721759|NCT00154375|B2|Baseline|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
721760|NCT00154375|B1|Baseline|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
721761|NCT00154375|P2|Participant Flow|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
721762|NCT00154375|P1|Participant Flow|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
721763|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
721764|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
721765|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
721766|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
721767|NCT00154375|E3|Reported Event|Period After Switch to Combination|After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
721768|NCT00154375|E2|Reported Event|Period With Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily.
721769|NCT00154375|E1|Reported Event|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
721770|NCT00154310|B3|Baseline|Total|Total of all reporting groups
721771|NCT00154310|B2|Baseline|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
721772|NCT00154310|B1|Baseline|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
721773|NCT00154310|P2|Participant Flow|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
721774|NCT00154310|P1|Participant Flow|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
721775|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
721776|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
721777|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
721802|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
722379|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
721778|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
721779|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
721780|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
721781|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
721782|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
721783|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
721784|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
721785|NCT00154310|E2|Reported Event|Sandimmun Optoral|Sandimmun Optoral
721786|NCT00154310|E1|Reported Event|Certican|Certican
721787|NCT00154297|B3|Baseline|Total|Total of all reporting groups
721788|NCT00154297|B2|Baseline|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721789|NCT00154297|B1|Baseline|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721790|NCT00154297|P2|Participant Flow|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721791|NCT00154297|P1|Participant Flow|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721792|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721793|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721794|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721795|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721796|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721797|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721798|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721799|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721800|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721801|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721803|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721804|NCT00154297|E2|Reported Event|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
721805|NCT00154297|E1|Reported Event|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
721806|NCT00154284|B3|Baseline|Total|Total of all reporting groups
721807|NCT00154284|B2|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721808|NCT00154284|B1|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721809|NCT00154284|P2|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721810|NCT00154284|P1|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721811|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721812|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721813|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721814|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721830|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721831|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721815|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721816|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721817|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721818|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721819|NCT00154284|E2|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721820|NCT00154284|E1|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
721821|NCT00154102|B3|Baseline|Total|Total of all reporting groups
721822|NCT00154102|B2|Baseline|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721823|NCT00154102|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721824|NCT00154102|P2|Participant Flow|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721825|NCT00154102|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721826|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721827|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721828|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721829|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721832|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721833|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721834|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721835|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721836|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721837|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721838|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721839|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721840|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721841|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721842|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721843|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721844|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721845|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721846|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721847|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721848|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721849|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721850|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721872|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721851|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721852|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721853|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721854|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721855|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
721856|NCT00154102|E2|Reported Event|FOLFIRI Alone|"Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects"
721857|NCT00154102|E1|Reported Event|Cetuximab Plus FOLFIRI|"Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects."
721858|NCT00154063|B3|Baseline|Total|Total of all reporting groups
721859|NCT00154063|B2|Baseline|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721860|NCT00154063|B1|Baseline|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721861|NCT00154063|P2|Participant Flow|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721862|NCT00154063|P1|Participant Flow|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721863|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721864|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721865|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721866|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721867|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721868|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721869|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721870|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721871|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
722016|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722017|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
721873|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721874|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721875|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721876|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721877|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721878|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721879|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721880|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721881|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721882|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721883|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721884|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721885|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721886|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721887|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721888|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721889|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721890|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721891|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721892|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721893|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721894|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
722018|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722019|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
721895|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721896|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721897|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721898|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721899|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721900|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721901|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721902|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721903|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721904|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721905|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721906|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721907|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721908|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721909|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721910|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721911|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721912|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721913|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721914|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721915|NCT00154063|E2|Reported Event|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
721916|NCT00154063|E1|Reported Event|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
722020|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
721917|NCT00153985|B1|Baseline|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
721918|NCT00153985|P1|Participant Flow|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
721919|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
721920|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
721921|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
721922|NCT00153985|E1|Reported Event|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
721923|NCT00153920|B1|Baseline|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721924|NCT00153920|P1|Participant Flow|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721925|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721926|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721927|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721928|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721929|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721930|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721931|NCT00153920|E1|Reported Event|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
721932|NCT00153816|B7|Baseline|Total|Total of all reporting groups
721933|NCT00153816|B6|Baseline|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721934|NCT00153816|B5|Baseline|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721935|NCT00153816|B4|Baseline|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721936|NCT00153816|B3|Baseline|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721937|NCT00153816|B2|Baseline|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721938|NCT00153816|B1|Baseline|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
721939|NCT00153816|P6|Participant Flow|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721940|NCT00153816|P5|Participant Flow|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
722021|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722022|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
721941|NCT00153816|P4|Participant Flow|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721942|NCT00153816|P3|Participant Flow|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721943|NCT00153816|P2|Participant Flow|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721944|NCT00153816|P1|Participant Flow|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
721945|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721946|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721947|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721948|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721949|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721950|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
721951|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721952|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721953|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721954|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721955|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721956|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
721957|NCT00153816|E6|Reported Event|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721958|NCT00153816|E5|Reported Event|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721959|NCT00153816|E4|Reported Event|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721960|NCT00153816|E3|Reported Event|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
721961|NCT00153816|E2|Reported Event|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
721962|NCT00153816|E1|Reported Event|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
721963|NCT00153179|B3|Baseline|Total|Total of all reporting groups
721964|NCT00153179|B2|Baseline|Metabolic Syndrome|
721965|NCT00153179|B1|Baseline|Healthy Controls|
721966|NCT00153179|P4|Participant Flow|Metabolic Syndrome, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
721967|NCT00153179|P3|Participant Flow|Metabolic Syndrome, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
721968|NCT00153179|P2|Participant Flow|Healthy Controls, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
721969|NCT00153179|P1|Participant Flow|Healthy Controls, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
721970|NCT00153179|O4|Outcome|Metabolic Syndrome, Acipimox Treatment|
721971|NCT00153179|O3|Outcome|Metabolic Syndrome, Placebo Treatment|
721972|NCT00153179|O2|Outcome|Healthy Controls, Acipimox Treatment|
721973|NCT00153179|O1|Outcome|Healthy Controls, Placebo Treatment|
721974|NCT00153179|E2|Reported Event|Metabolic Syndrome|
721975|NCT00153179|E1|Reported Event|Healthy Controls|
721976|NCT00153166|B4|Baseline|Total|Total of all reporting groups
721977|NCT00153166|B3|Baseline|PAD Without Diabetes|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
721978|NCT00153166|B2|Baseline|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
721979|NCT00153166|B1|Baseline|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
721980|NCT00153166|P3|Participant Flow|PAD (Excluding Patients With Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Excluding those patients with diabetes. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
721981|NCT00153166|P2|Participant Flow|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
721982|NCT00153166|P1|Participant Flow|Healthy Controls|Healthy individuals, non-smokers, normal CV examination. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
721983|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
721984|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
721985|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
721986|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
721987|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
721988|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
721989|NCT00153166|E4|Reported Event|Received Placebo/Placebo|Including healthy subjects and subjects with PAD
721990|NCT00153166|E3|Reported Event|Received Placebo/Pioglitazone|Including healthy subjects and subjects with PAD
721991|NCT00153166|E2|Reported Event|Received Atorvastatin/Placebo|Including healthy subjects and subjects with PAD
721992|NCT00153166|E1|Reported Event|Received Atorvastatin/Pioglitazone|Including healthy subjects and subjects with PAD
721993|NCT00153101|B6|Baseline|Total|Total of all reporting groups
721994|NCT00153101|B5|Baseline|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
721995|NCT00153101|B4|Baseline|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
721996|NCT00153101|B3|Baseline|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
721997|NCT00153101|B2|Baseline|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
721998|NCT00153101|B1|Baseline|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
721999|NCT00153101|P5|Participant Flow|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722000|NCT00153101|P4|Participant Flow|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722001|NCT00153101|P3|Participant Flow|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722002|NCT00153101|P2|Participant Flow|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722003|NCT00153101|P1|Participant Flow|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722004|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722005|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722006|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722007|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722008|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722009|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722010|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722011|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722012|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722013|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722014|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722015|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722380|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
722024|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722025|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722026|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722027|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722028|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722029|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722030|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722031|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722032|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722033|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722034|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722035|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722036|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722037|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722038|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722039|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722040|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722041|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722042|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722043|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722044|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722045|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722046|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722047|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722048|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722049|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722050|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722051|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722052|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722053|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722054|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722055|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722056|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722057|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722058|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722059|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722060|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722061|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722062|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722063|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722064|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722065|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722066|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722067|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722068|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722069|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722070|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722071|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722072|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722073|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722074|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722075|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722076|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722077|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722078|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722079|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722080|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722081|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722082|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722083|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722084|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722085|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722086|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722087|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722088|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722089|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722090|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722091|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722092|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722093|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722094|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722095|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722096|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722097|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722098|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722099|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722100|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722101|NCT00153101|E5|Reported Event|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
722102|NCT00153101|E4|Reported Event|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
722103|NCT00153101|E3|Reported Event|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
722104|NCT00153101|E2|Reported Event|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
722105|NCT00153101|E1|Reported Event|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
722106|NCT00153062|B5|Baseline|Total|Total of all reporting groups
722107|NCT00153062|B4|Baseline|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
722108|NCT00153062|B3|Baseline|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
722109|NCT00153062|B2|Baseline|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
722381|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
722110|NCT00153062|B1|Baseline|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
722111|NCT00153062|P4|Participant Flow|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
722112|NCT00153062|P3|Participant Flow|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
722113|NCT00153062|P2|Participant Flow|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
722114|NCT00153062|P1|Participant Flow|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
722115|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
722116|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
722117|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
722118|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
722119|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
722120|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
722121|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
722122|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
722123|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
722124|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
722125|NCT00153062|E4|Reported Event|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
722126|NCT00153062|E3|Reported Event|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
722127|NCT00153062|E2|Reported Event|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
722128|NCT00153062|E1|Reported Event|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
722129|NCT00152971|B4|Baseline|Total|Total of all reporting groups
722130|NCT00152971|B3|Baseline|Enoxaparin|30mg bid (twice daily) subcutaneous
722131|NCT00152971|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
722132|NCT00152971|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
722133|NCT00152971|P3|Participant Flow|Enoxaparin|30mg bid (twice daily) subcutaneous
722134|NCT00152971|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
722135|NCT00152971|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
722136|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722137|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722138|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722139|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722140|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722141|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722142|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722143|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722144|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722145|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722146|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722147|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722148|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722149|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722150|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722151|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722152|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722153|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722154|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722155|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722156|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722157|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722158|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722159|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722160|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
722161|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
722162|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
722163|NCT00152971|E3|Reported Event|Enoxaparin|30mg bid (twice daily) subcutaneous
722164|NCT00152971|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
722165|NCT00152971|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
722166|NCT00152763|B5|Baseline|Total|Total of all reporting groups
722167|NCT00152763|B4|Baseline|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722320|NCT00152009|P2|Participant Flow|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722321|NCT00152009|P1|Participant Flow|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722322|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
722168|NCT00152763|B3|Baseline|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722169|NCT00152763|B2|Baseline|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722170|NCT00152763|B1|Baseline|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722171|NCT00152763|P4|Participant Flow|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722172|NCT00152763|P3|Participant Flow|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722173|NCT00152763|P2|Participant Flow|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722174|NCT00152763|P1|Participant Flow|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722175|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet. These data are on men and women combined within CBT.
722176|NCT00152763|O1|Outcome|Usual Cardiac Care|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This includes all men and women who received UCC.
722177|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722178|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722179|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722180|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722181|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722182|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722183|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722184|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722185|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722186|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722187|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722188|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722189|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722190|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722191|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722192|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722193|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722194|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722195|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722196|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722197|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722198|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722199|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722200|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722201|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722202|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722203|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722204|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722205|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722206|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722207|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722323|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722208|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722209|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722210|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722211|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722212|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722213|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722214|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722215|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722216|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722217|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722218|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722219|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722220|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722221|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722222|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722223|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722224|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722225|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722226|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722227|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722324|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722228|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722229|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722230|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722231|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722232|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722233|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722234|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722235|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722236|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722237|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722238|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722239|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722240|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722241|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722242|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722243|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722244|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722245|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722246|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722247|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722325|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722248|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722249|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722250|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722251|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722252|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722253|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722254|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722255|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722256|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722257|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722258|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722259|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722260|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722261|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722262|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722263|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722264|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722265|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722266|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722267|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722326|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
722268|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722269|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722270|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722271|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722272|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722273|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722274|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722275|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722276|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722277|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722278|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722279|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722280|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722281|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722282|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722283|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722284|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722285|NCT00152763|E4|Reported Event|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
722286|NCT00152763|E3|Reported Event|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722287|NCT00152763|E2|Reported Event|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
722327|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722288|NCT00152763|E1|Reported Event|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
722289|NCT00152516|B1|Baseline|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722290|NCT00152516|P1|Participant Flow|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722291|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722292|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722293|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722294|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722295|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722296|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722297|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722298|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722299|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722300|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722301|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722302|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722303|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722304|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722305|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722306|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722307|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722308|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722309|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722310|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722311|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722312|NCT00152516|E1|Reported Event|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
722313|NCT00152009|B5|Baseline|Total|Total of all reporting groups
722314|NCT00152009|B4|Baseline|Placebo|Subjects were randomized to receive Placebo once-daily.
722315|NCT00152009|B3|Baseline|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722316|NCT00152009|B2|Baseline|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722317|NCT00152009|B1|Baseline|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722318|NCT00152009|P4|Participant Flow|Placebo|Subjects were randomized to receive Placebo once-daily.
722319|NCT00152009|P3|Participant Flow|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722369|NCT00151892|B1|Baseline|SPD476|2.4 g/day QD
722328|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722329|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722330|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
722331|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722332|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722333|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722334|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
722335|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722336|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722337|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722338|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
722339|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722340|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722341|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722342|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
722343|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722344|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722345|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722346|NCT00152009|E4|Reported Event|Placebo|Subjects were randomized to receive Placebo once-daily.
722347|NCT00152009|E3|Reported Event|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
722348|NCT00152009|E2|Reported Event|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
722349|NCT00152009|E1|Reported Event|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
722350|NCT00151996|B3|Baseline|Total|Total of all reporting groups
722351|NCT00151996|B2|Baseline|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722352|NCT00151996|B1|Baseline|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722353|NCT00151996|P2|Participant Flow|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722354|NCT00151996|P1|Participant Flow|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722355|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722356|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722357|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722358|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722359|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722360|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722361|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722362|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722363|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722364|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722365|NCT00151996|E2|Reported Event|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
722366|NCT00151996|E1|Reported Event|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
722367|NCT00151892|B3|Baseline|Total|Total of all reporting groups
722368|NCT00151892|B2|Baseline|Asacol|1.6g/day administered 800 mg BID
722382|NCT00151892|E2|Reported Event|Asacol|1.6g/day administered 800 mg BID
722383|NCT00151892|E1|Reported Event|SPD476|2.4 g/day QD
722384|NCT00151814|B4|Baseline|Total|Total of all reporting groups
722385|NCT00151814|B3|Baseline|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722386|NCT00151814|B2|Baseline|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722387|NCT00151814|B1|Baseline|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722388|NCT00151814|P3|Participant Flow|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722389|NCT00151814|P2|Participant Flow|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722390|NCT00151814|P1|Participant Flow|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722391|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722392|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722393|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722394|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722395|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722396|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722397|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722398|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722399|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722400|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722401|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722402|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722403|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722404|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722405|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722572|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722573|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722574|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722406|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722407|NCT00151814|E3|Reported Event|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722408|NCT00151814|E2|Reported Event|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722409|NCT00151814|E1|Reported Event|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
722410|NCT00151775|B6|Baseline|Total|Total of all reporting groups
722411|NCT00151775|B5|Baseline|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722412|NCT00151775|B4|Baseline|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722413|NCT00151775|B3|Baseline|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722414|NCT00151775|B2|Baseline|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722415|NCT00151775|B1|Baseline|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722416|NCT00151775|P12|Participant Flow|Cohort C: Placebo in Period 3 (From OM in Period 2)|Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
722417|NCT00151775|P11|Participant Flow|Cohort C: OM in Periods 2, 3, 4|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722418|NCT00151775|P10|Participant Flow|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722419|NCT00151775|P9|Participant Flow|Cohort B: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
722420|NCT00151775|P8|Participant Flow|Cohort B: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan.
722421|NCT00151775|P7|Participant Flow|Cohort B: Low Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
722422|NCT00151775|P6|Participant Flow|Cohort B: High Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
722423|NCT00151775|P5|Participant Flow|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722424|NCT00151775|P4|Participant Flow|Cohort A: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
722575|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722576|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722425|NCT00151775|P3|Participant Flow|Cohort A: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan
722426|NCT00151775|P2|Participant Flow|Cohort A: Low Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
722427|NCT00151775|P1|Participant Flow|Cohort A: High Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
722428|NCT00151775|O1|Outcome|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722429|NCT00151775|O3|Outcome|Cohorts A + B: Period 4 Open-label OM|All members of Cohorts A + B (6-16 years old) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722430|NCT00151775|O2|Outcome|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722431|NCT00151775|O1|Outcome|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722432|NCT00151775|O2|Outcome|Cohort C: Placebo Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.
722433|NCT00151775|O1|Outcome|Cohort C: OM Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.
722434|NCT00151775|O6|Outcome|Cohorts A + B: Placebo Period 3|Cohorts A + B participants were 6-16 years old. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
722435|NCT00151775|O5|Outcome|Cohorts A + B: OM Period 3|Cohort A + B participants were 6-16 years old. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
722436|NCT00151775|O4|Outcome|Cohort B: Placebo Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
722437|NCT00151775|O3|Outcome|Cohort B: OM Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
722438|NCT00151775|O2|Outcome|Cohort A: Placebo Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
722439|NCT00151775|O1|Outcome|Cohort A: OM Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
722440|NCT00151775|O6|Outcome|Cohorts A + B: High Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
722441|NCT00151775|O5|Outcome|Cohorts A + B: Low Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
722442|NCT00151775|O4|Outcome|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722443|NCT00151775|O3|Outcome|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722444|NCT00151775|O2|Outcome|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722445|NCT00151775|O1|Outcome|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
722446|NCT00151775|O3|Outcome|Cohorts A + B|Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
722447|NCT00151775|O2|Outcome|Cohort B|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
722448|NCT00151775|O1|Outcome|Cohort A|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
722449|NCT00151775|E18|Reported Event|Cohort C: Period 4 Open-label OM|Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722450|NCT00151775|E17|Reported Event|Cohort C: Period 3 Placebo|The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.
722451|NCT00151775|E16|Reported Event|Cohort C: Period 3 OM Dose Continued|The 0.3 mg/kg dose of OM was continued for these participants
722452|NCT00151775|E15|Reported Event|Cohort C: Period 2 Open-label OM|The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.
722453|NCT00151775|E14|Reported Event|Cohort B: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722454|NCT00151775|E13|Reported Event|Cohort B: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
722455|NCT00151775|E12|Reported Event|Cohort B: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
722456|NCT00151775|E11|Reported Event|Cohort B: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
722457|NCT00151775|E10|Reported Event|Cohort B: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
722458|NCT00151775|E9|Reported Event|Cohort B: Period 2 Low Dose OM|For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
722459|NCT00151775|E8|Reported Event|Cohort B: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
722460|NCT00151775|E7|Reported Event|Cohort A: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
722461|NCT00151775|E6|Reported Event|Cohort A: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
722462|NCT00151775|E5|Reported Event|Cohort A: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
722463|NCT00151775|E4|Reported Event|Cohort A: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
722464|NCT00151775|E3|Reported Event|Cohort A: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
722465|NCT00151775|E2|Reported Event|Cohort A: Period 2 Low Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
722466|NCT00151775|E1|Reported Event|Cohort A: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
722467|NCT00151476|B4|Baseline|Total|Total of all reporting groups
722468|NCT00151476|B3|Baseline|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722469|NCT00151476|B2|Baseline|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722470|NCT00151476|B1|Baseline|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722577|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722578|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722579|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722580|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722581|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722582|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722471|NCT00151476|P2|Participant Flow|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722472|NCT00151476|P1|Participant Flow|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722473|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722474|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722475|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722476|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722477|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722478|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722479|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722480|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722481|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722482|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722483|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722484|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722485|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722486|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722487|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722488|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722489|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722490|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722491|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722492|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722493|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722494|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722495|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722496|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722497|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722583|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722584|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722585|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722586|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722498|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722499|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722500|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722501|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722502|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722503|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722504|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722505|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722506|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722507|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722508|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722509|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722510|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722511|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722512|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722513|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722514|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722515|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722516|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722517|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722518|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722519|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722520|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722521|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722522|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722523|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722524|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722587|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722588|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
722589|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722590|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
722591|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722525|NCT00151476|E1|Reported Event|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
722526|NCT00151411|B3|Baseline|Total|Total of all reporting groups
722527|NCT00151411|B2|Baseline|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
722528|NCT00151411|B1|Baseline|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
722529|NCT00151411|P2|Participant Flow|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
722530|NCT00151411|P1|Participant Flow|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
722531|NCT00151411|O2|Outcome|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
722532|NCT00151411|O1|Outcome|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
722533|NCT00151411|O2|Outcome|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
722534|NCT00151411|O1|Outcome|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
722535|NCT00151411|O2|Outcome|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
722536|NCT00151411|O1|Outcome|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
722537|NCT00151411|E2|Reported Event|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
722538|NCT00151411|E1|Reported Event|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
722539|NCT00151372|B3|Baseline|Total|Total of all reporting groups
722540|NCT00151372|B2|Baseline|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
722541|NCT00151372|B1|Baseline|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
722542|NCT00151372|P2|Participant Flow|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
722543|NCT00151372|P1|Participant Flow|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
722544|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
722545|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
722546|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
722547|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
722548|NCT00151372|E2|Reported Event|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
722549|NCT00151372|E1|Reported Event|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
722550|NCT00151320|B3|Baseline|Total|Total of all reporting groups
722551|NCT00151320|B2|Baseline|Untreated MCL|with untreated mantle cell Non-Hodgkin’s Lymphoma
722552|NCT00151320|B1|Baseline|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
722553|NCT00151320|P1|Participant Flow|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles~Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.~Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
722554|NCT00151320|O2|Outcome|Untreated MCL|with untreated mantle cell Non-Hodgkin’s Lymphoma
722555|NCT00151320|O1|Outcome|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
722556|NCT00151320|E1|Reported Event|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles~Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.~Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
722557|NCT00151281|B1|Baseline|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
722558|NCT00151281|P1|Participant Flow|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
722559|NCT00151281|O1|Outcome|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
722560|NCT00151281|O1|Outcome|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
722561|NCT00151281|O1|Outcome|RT-PEPC Drug Therapy|"PEPC Induction phase PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis Maintenance phase PEPC QOD or fractionated weekly basis. Post-Month 12 Maintenance phase PEPC QOD or fractionated weekly basis Thalidomide Induction phase Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase Daily low dose thalidomide (50-100 mg/d) Post-Month 12 Maintenance phase Daily low dose thalidomide (50-100mg/d) Rituximab Induction phase Rituximab weekly x 4 (375 mg/m2/week) starting at week 1. Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months. Post-Month 12 Maintenance phase Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
722562|NCT00151281|O1|Outcome|Study Treatment Arm|"Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide: Induction phase (month 1-3)~PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.~Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.~Maintenance phase (month 4-12)~Daily low dose thalidomide (50-100 mg/d)~PEPC QOD or fractionated weekly basis.~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.~Post-Month 12 Maintenance phase (post-month 12 until disease progression)~Daily low dose thalidomide (50-100mg/d)~PEPC QOD or fractionated weekly basis~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
722563|NCT00151281|E1|Reported Event|Study Treatment Arm|"Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide: Induction phase (month 1-3)~PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.~Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.~Maintenance phase (month 4-12)~Daily low dose thalidomide (50-100 mg/d)~PEPC QOD or fractionated weekly basis.~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.~Post-Month 12 Maintenance phase (post-month 12 until disease progression)~Daily low dose thalidomide (50-100mg/d)~PEPC QOD or fractionated weekly basis~Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"
722564|NCT00150969|B3|Baseline|Total|Total of all reporting groups
722565|NCT00150969|B2|Baseline|Placebo|dummy pill identicle to vitamin k
722566|NCT00150969|B1|Baseline|Phyloquinone|5 mg Vitamin K1
722567|NCT00150969|P2|Participant Flow|Placebo|dummy pill identicle to vitamin k
722568|NCT00150969|P1|Participant Flow|Phyloquinone|5 mg Vitamin K1
722569|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722570|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722571|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
722596|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
722597|NCT00150969|E2|Reported Event|Placebo|dummy pill identicle to vitamin k
722598|NCT00150969|E1|Reported Event|Phyloquinone|5 mg Vitamin K1
722599|NCT00150618|B6|Baseline|Total|Total of all reporting groups
722600|NCT00150618|B5|Baseline|Placebo|once daily
722601|NCT00150618|B4|Baseline|SPD503 (4 mg)|Guanfacine HCl once daily
722602|NCT00150618|B3|Baseline|SPD503 (3 mg)|Guanfacine HCl once daily
722603|NCT00150618|B2|Baseline|SPD503 (2 mg)|Guanfacine HCl once daily
722604|NCT00150618|B1|Baseline|SPD503 (1 mg)|Guanfacine HCl once daily
722605|NCT00150618|P5|Participant Flow|Placebo|once daily
722606|NCT00150618|P4|Participant Flow|SPD503 (4 mg)|Guanfacine HCl once daily
722607|NCT00150618|P3|Participant Flow|SPD503 (3 mg)|Guanfacine HCl once daily
722608|NCT00150618|P2|Participant Flow|SPD503 (2 mg)|Guanfacine HCl once daily
722609|NCT00150618|P1|Participant Flow|SPD503 (1 mg)|Guanfacine HCl once daily
722610|NCT00150618|O5|Outcome|Placebo|once daily
722611|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
722612|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
722613|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
722614|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
722615|NCT00150618|O5|Outcome|Placebo|once daily
722616|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
722617|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
722618|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
722619|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
722620|NCT00150618|O5|Outcome|Placebo|once daily
722621|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
722622|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
722623|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
722624|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
722625|NCT00150618|O5|Outcome|Placebo|once daily
722626|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
722627|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
722628|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
722629|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
722630|NCT00150618|O5|Outcome|Placebo|once daily
722631|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
722632|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
722633|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
722634|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
722635|NCT00150618|E5|Reported Event|Placebo|once daily
722636|NCT00150618|E4|Reported Event|SPD503 (4 mg)|Guanfacine HCl once daily
722637|NCT00150618|E3|Reported Event|SPD503 (3 mg)|Guanfacine HCl once daily
722638|NCT00150618|E2|Reported Event|SPD503 (2 mg)|Guanfacine HCl once daily
722639|NCT00150618|E1|Reported Event|SPD503 (1 mg)|Guanfacine HCl once daily
722640|NCT00150592|B3|Baseline|Total|Total of all reporting groups
722641|NCT00150592|B2|Baseline|Placebo|
722642|NCT00150592|B1|Baseline|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722643|NCT00150592|P2|Participant Flow|Placebo|
722644|NCT00150592|P1|Participant Flow|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722645|NCT00150592|O2|Outcome|Placebo|
722646|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722647|NCT00150592|O2|Outcome|Placebo|
722648|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722649|NCT00150592|O2|Outcome|Placebo|
722650|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722651|NCT00150592|O2|Outcome|Placebo|
722652|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722653|NCT00150592|O2|Outcome|Placebo|
722654|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722655|NCT00150592|O2|Outcome|Placebo|
722656|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722657|NCT00150592|O2|Outcome|Placebo|
722658|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722659|NCT00150592|O2|Outcome|Placebo|
722660|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722661|NCT00150592|E2|Reported Event|Placebo|
722662|NCT00150592|E1|Reported Event|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
722663|NCT00150462|B12|Baseline|Total|Total of all reporting groups
722664|NCT00150462|B11|Baseline|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722665|NCT00150462|B10|Baseline|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722666|NCT00150462|B9|Baseline|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722667|NCT00150462|B8|Baseline|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722668|NCT00150462|B7|Baseline|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722669|NCT00150462|B6|Baseline|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722670|NCT00150462|B5|Baseline|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722671|NCT00150462|B4|Baseline|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722672|NCT00150462|B3|Baseline|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722673|NCT00150462|B2|Baseline|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722674|NCT00150462|B1|Baseline|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722675|NCT00150462|P11|Participant Flow|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722676|NCT00150462|P10|Participant Flow|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722677|NCT00150462|P9|Participant Flow|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722678|NCT00150462|P8|Participant Flow|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722679|NCT00150462|P7|Participant Flow|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722680|NCT00150462|P6|Participant Flow|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722681|NCT00150462|P5|Participant Flow|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722682|NCT00150462|P4|Participant Flow|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722683|NCT00150462|P3|Participant Flow|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722684|NCT00150462|P2|Participant Flow|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722685|NCT00150462|P1|Participant Flow|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722686|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722687|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722688|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722689|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722690|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722691|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722692|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722693|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722694|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722695|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722696|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722697|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722698|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722699|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
723019|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
722700|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722701|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722702|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722703|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722704|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722705|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722706|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722707|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722708|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722709|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722710|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722711|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722712|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722713|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722714|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722715|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722716|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722717|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722718|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722719|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722720|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722721|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722722|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722723|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722724|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722725|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722726|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722727|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722728|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722729|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722730|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722731|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
723020|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
722732|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722733|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722734|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722735|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722736|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722737|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722738|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722739|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722740|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722741|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722742|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722743|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722744|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722745|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722746|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722747|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722748|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722749|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722750|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722751|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722752|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722753|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722754|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722755|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722756|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722757|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722758|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722759|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722760|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722761|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722762|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722763|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
723021|NCT00149396|O2|Outcome|Stage 2|Optimal dose from Stage 1: 1x10^8 pfu
722764|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722765|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722766|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722767|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722768|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722769|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722770|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722771|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722772|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722773|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722774|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722775|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722776|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722777|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722778|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722779|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722780|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722781|NCT00150462|E11|Reported Event|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
722782|NCT00150462|E10|Reported Event|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
722783|NCT00150462|E9|Reported Event|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722784|NCT00150462|E8|Reported Event|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722785|NCT00150462|E7|Reported Event|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722786|NCT00150462|E6|Reported Event|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722787|NCT00150462|E5|Reported Event|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722788|NCT00150462|E4|Reported Event|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722789|NCT00150462|E3|Reported Event|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722790|NCT00150462|E2|Reported Event|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722791|NCT00150462|E1|Reported Event|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
722792|NCT00150345|B3|Baseline|Total|Total of all reporting groups
722793|NCT00150345|B2|Baseline|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722914|NCT00149799|P2|Participant Flow|Phase II: Double-blind Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
722794|NCT00150345|B1|Baseline|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722795|NCT00150345|P2|Participant Flow|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722796|NCT00150345|P1|Participant Flow|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722797|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722798|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722799|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722800|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722801|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722802|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722803|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722804|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722805|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722882|NCT00149890|P1|Participant Flow|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722806|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722807|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722808|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722809|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722810|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722811|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722812|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722813|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722814|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722815|NCT00150345|O2|Outcome|Deferred Voricoazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722816|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722817|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722883|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722818|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722819|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722820|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722821|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722822|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722823|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722824|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722825|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722826|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722827|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722828|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722829|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722884|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
723860|NCT00146172|O5|Outcome|Neratinib 240 mg|Neratinib 240 mg qd
722830|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722831|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722832|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722833|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722834|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722835|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722836|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722837|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722838|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722839|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722840|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722841|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722885|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722842|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722843|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722844|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722845|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722846|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722847|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722848|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722849|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722850|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722851|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722852|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722853|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722886|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
723861|NCT00146172|O4|Outcome|Neratinib 180 mg|Neratinib 180 mg qd
722854|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722855|NCT00150345|E2|Reported Event|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722856|NCT00150345|E1|Reported Event|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
722857|NCT00150176|B3|Baseline|Total|Total of all reporting groups
722858|NCT00150176|B2|Baseline|Placebo|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
722859|NCT00150176|B1|Baseline|Asenapine|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
722860|NCT00150176|P2|Participant Flow|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
722861|NCT00150176|P1|Participant Flow|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
722862|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
722863|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
722864|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
722865|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
722866|NCT00150176|E3|Reported Event|Asenapine During Open-Label Phase and Not Randomized|Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase & Not Randomized' Group includes subjects who received >= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
722867|NCT00150176|E2|Reported Event|Placebo|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
722868|NCT00150176|E1|Reported Event|Asenapine|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
722869|NCT00149994|B3|Baseline|Total|Total of all reporting groups
722870|NCT00149994|B2|Baseline|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
722871|NCT00149994|B1|Baseline|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
722872|NCT00149994|P2|Participant Flow|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
722873|NCT00149994|P1|Participant Flow|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
722874|NCT00149994|O2|Outcome|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
722875|NCT00149994|O1|Outcome|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
722876|NCT00149994|E2|Reported Event|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
722877|NCT00149994|E1|Reported Event|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
722878|NCT00149890|B3|Baseline|Total|Total of all reporting groups
722879|NCT00149890|B2|Baseline|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722880|NCT00149890|B1|Baseline|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722881|NCT00149890|P2|Participant Flow|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722913|NCT00149799|P3|Participant Flow|Phase II: Double-blind Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
722887|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722888|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722889|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722890|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722891|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722892|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722893|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722894|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722895|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722896|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722897|NCT00149890|E2|Reported Event|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
722898|NCT00149890|E1|Reported Event|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
722899|NCT00149825|B3|Baseline|Total|Total of all reporting groups
722900|NCT00149825|B2|Baseline|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
722901|NCT00149825|B1|Baseline|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
722902|NCT00149825|P2|Participant Flow|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
722903|NCT00149825|P1|Participant Flow|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
722904|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
722905|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
722906|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
722907|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
722908|NCT00149825|E2|Reported Event|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
722909|NCT00149825|E1|Reported Event|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
722910|NCT00149799|B3|Baseline|Total|Total of all reporting groups
722911|NCT00149799|B2|Baseline|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
722912|NCT00149799|B1|Baseline|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
723669|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
722915|NCT00149799|P1|Participant Flow|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
722916|NCT00149799|O2|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
722917|NCT00149799|O1|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
722918|NCT00149799|O2|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
722919|NCT00149799|O1|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
722920|NCT00149799|O2|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
722921|NCT00149799|O1|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
722922|NCT00149799|O1|Outcome|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
722923|NCT00149799|O2|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
722924|NCT00149799|O1|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
722925|NCT00149799|E3|Reported Event|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
722926|NCT00149799|E2|Reported Event|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
722927|NCT00149799|E1|Reported Event|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
722928|NCT00149747|B3|Baseline|Total|Total of all reporting groups
722929|NCT00149747|B2|Baseline|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
722930|NCT00149747|B1|Baseline|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
722931|NCT00149747|P2|Participant Flow|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
722932|NCT00149747|P1|Participant Flow|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
722933|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
722934|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
722935|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
722936|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
722937|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
722938|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
722939|NCT00149747|E2|Reported Event|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
722940|NCT00149747|E1|Reported Event|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
722941|NCT00149669|B3|Baseline|Total|Total of all reporting groups
722942|NCT00149669|B2|Baseline|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722963|NCT00149643|B2|Baseline|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
722964|NCT00149643|B1|Baseline|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
723862|NCT00146172|O3|Outcome|Neratinib 120 mg|Neratinib 120 mg qd
722943|NCT00149669|B1|Baseline|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722944|NCT00149669|P2|Participant Flow|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722945|NCT00149669|P1|Participant Flow|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722946|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
722947|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
722948|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
722949|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
722950|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
722951|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
722952|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
722953|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
722954|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
722955|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
722956|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
722957|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
722958|NCT00149669|O2|Outcome|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722959|NCT00149669|O1|Outcome|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722960|NCT00149669|E2|Reported Event|Work Plus Naltrexone Contingency|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722961|NCT00149669|E1|Reported Event|Work Plus Naltrexone Prescription|Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work.
722962|NCT00149643|B3|Baseline|Total|Total of all reporting groups
723018|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
722965|NCT00149643|P2|Participant Flow|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
722966|NCT00149643|P1|Participant Flow|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
722967|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
722968|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
722969|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
722970|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
722971|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
722972|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
722973|NCT00149643|E2|Reported Event|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
722974|NCT00149643|E1|Reported Event|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
722975|NCT00149630|B3|Baseline|Total|Total of all reporting groups
722976|NCT00149630|B2|Baseline|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
722977|NCT00149630|B1|Baseline|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
722978|NCT00149630|P2|Participant Flow|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
722979|NCT00149630|P1|Participant Flow|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
722980|NCT00149630|O2|Outcome|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
722981|NCT00149630|O1|Outcome|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
722982|NCT00149630|O4|Outcome|Disulfiram CT/TT|Subjects who received Disulfiram with genotype CT/TT.
722983|NCT00149630|O3|Outcome|Disulfiram CC|Subjects who received Disulfiram with genotype CC.
722984|NCT00149630|O2|Outcome|Placebo CT/TT|Subjects who received placebo with genotype CT/TT.
722985|NCT00149630|O1|Outcome|Placebo CC|Subjects who received placebo with a genotype of CC.
722986|NCT00149630|E2|Reported Event|Placebo|Inactive medicine (placebo)with methadone during study weeks 2-13. Inactive medicine discontinued during study weeks 14-15.
722987|NCT00149630|E1|Reported Event|Disulfarim|250 mg/day with methadone daily during study weeks 2-13. Study medicine discontinued during study weeks 14-15.
722988|NCT00149396|B1|Baseline|NV1020|Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
722989|NCT00149396|P1|Participant Flow|NV1020|Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
722990|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
722991|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
722992|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
722993|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
722994|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
722995|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
722996|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
722997|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
722998|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
722999|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
723000|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
723001|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
723002|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
723003|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
723004|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
723005|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
723006|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
723007|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
723008|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
723009|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
723010|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
723011|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
723012|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose: 1x10^7 pfu (Stage 1)
723013|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
723014|NCT00149396|O1|Outcome|All Patients|All patients in study
723015|NCT00149396|O2|Outcome|Stage 2|Optimal dose from Stage 1: 1x10^8 pfu
723016|NCT00149396|O1|Outcome|Stage 1|Escalating doses of NV1020: 3x10^6 pfu, 1x10^7 pfu, 3x10^7 pfu, 1x10^8 pfu
723017|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
723022|NCT00149396|O1|Outcome|Stage 1|Escalating doses of NV1020: 3x10^6 pfu, 1x10^7 pfu, 3x10^7 pfu, 1x10^8 pfu
723023|NCT00149396|O4|Outcome|Dose Cohort 4|NV1020 Dose 1x10^8 pfu (Stages 1 and 2)
723024|NCT00149396|O3|Outcome|Dose Cohort 3|NV1020 Dose 3x10^7 pfu (Stage 1)
723025|NCT00149396|O2|Outcome|Dose Cohort 2|NV1020 Dose 1x10^7 pfu (Stage 1)
723026|NCT00149396|O1|Outcome|Dose Cohort 1|NV1020 Dose 3x10^6 pfu (Stage 1)
723027|NCT00149396|O1|Outcome|All Patients|All patients in study
723028|NCT00149396|E1|Reported Event|NV1020|Escalating doses of NV1020: 3x10^6, 1x10^7, 3x10^7, 1x10^8
723029|NCT00149227|B3|Baseline|Total|Total of all reporting groups
723030|NCT00149227|B2|Baseline|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723031|NCT00149227|B1|Baseline|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723032|NCT00149227|P2|Participant Flow|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723033|NCT00149227|P1|Participant Flow|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723034|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723035|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723036|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723037|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723038|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723039|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723040|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723041|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723042|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723043|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723044|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723045|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723046|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723069|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723047|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723048|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723049|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723050|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723051|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723052|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723053|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723054|NCT00149227|E2|Reported Event|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
723055|NCT00149227|E1|Reported Event|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
723056|NCT00149214|B3|Baseline|Total|Total of all reporting groups
723057|NCT00149214|B2|Baseline|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723058|NCT00149214|B1|Baseline|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723059|NCT00149214|P2|Participant Flow|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723060|NCT00149214|P1|Participant Flow|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723061|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723062|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723063|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723064|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723065|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723066|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723067|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723068|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723070|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723071|NCT00149214|E2|Reported Event|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723072|NCT00149214|E1|Reported Event|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
723073|NCT00148954|B3|Baseline|Total|Total of all reporting groups
723074|NCT00148954|B2|Baseline|Medtronic Family|Selected Medtronic family devices
723075|NCT00148954|B1|Baseline|VITALITY 2|VITALITY 2 ICD
723076|NCT00148954|P2|Participant Flow|Medtronic Family|Selected Medtronic family devices
723077|NCT00148954|P1|Participant Flow|VITALITY 2|VITALITY 2 ICD
723078|NCT00148954|O2|Outcome|Medtronic Family|Selected Medtronic family devices
723079|NCT00148954|O1|Outcome|VITALITY 2|VITALITY 2 ICD
723080|NCT00148954|E2|Reported Event|Medtronic Family|This study did not collect serious adverse events
723081|NCT00148954|E1|Reported Event|VITALITY 2|This study did not collect serious adverse events
723082|NCT00148798|B3|Baseline|Total|Total of all reporting groups
723083|NCT00148798|B2|Baseline|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723084|NCT00148798|B1|Baseline|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723085|NCT00148798|P2|Participant Flow|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723086|NCT00148798|P1|Participant Flow|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723087|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723088|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723089|NCT00148798|O2|Outcome|Cetuximab Concentration Before Infusion Week 7|
723090|NCT00148798|O1|Outcome|Cetuximab Concentration at End of Infusion Week 1|
723091|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723092|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723093|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723094|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723095|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723096|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723097|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723098|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723099|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723100|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723101|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723102|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723103|NCT00148798|E2|Reported Event|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723104|NCT00148798|E1|Reported Event|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
723105|NCT00148759|B3|Baseline|Total|Total of all reporting groups
723106|NCT00148759|B2|Baseline|Group 2|Female subjects
723107|NCT00148759|B1|Baseline|Group 1|Male subjects
723108|NCT00148759|P2|Participant Flow|Female Arm|Female subjects
723109|NCT00148759|P1|Participant Flow|Male Arm|Male subjects
723110|NCT00148759|O2|Outcome|Group 2|Female subjects
723111|NCT00148759|O1|Outcome|Group 1|Male subjects
723112|NCT00148759|O2|Outcome|Group 2|Female subjects
723113|NCT00148759|O1|Outcome|Group 1|Male subjects
723114|NCT00148759|E2|Reported Event|Group 2|Female subjects
723115|NCT00148759|E1|Reported Event|Group 1|Male subjects
723116|NCT00148733|B3|Baseline|Total|Total of all reporting groups
723117|NCT00148733|B2|Baseline|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723118|NCT00148733|B1|Baseline|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723119|NCT00148733|P2|Participant Flow|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723120|NCT00148733|P1|Participant Flow|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723121|NCT00148733|O2|Outcome|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723122|NCT00148733|O1|Outcome|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723123|NCT00148733|E2|Reported Event|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723124|NCT00148733|E1|Reported Event|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
723125|NCT00148668|B3|Baseline|Total|Total of all reporting groups
723126|NCT00148668|B2|Baseline|Arm 2|Taxotere/carboplatin/herceptin
723127|NCT00148668|B1|Baseline|Arm 1|Herceptin/navelbine
723128|NCT00148668|P2|Participant Flow|Taxotere/Carboplatin/Herceptin|Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles
723129|NCT00148668|P1|Participant Flow|Herceptin/Navelbine|Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks
723130|NCT00148668|O2|Outcome|Arm 2|Taxotere/carboplatin/herceptin
723131|NCT00148668|O1|Outcome|Arm 1|Herceptin/navelbine
723132|NCT00148668|E2|Reported Event|Arm 2|Taxotere/carboplatin/herceptin
723133|NCT00148668|E1|Reported Event|Arm 1|Herceptin/navelbine
723134|NCT00148317|B1|Baseline|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
723135|NCT00148317|P1|Participant Flow|Overall Study|
723136|NCT00148317|O1|Outcome|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
723137|NCT00148317|O1|Outcome|Treatment Arm - Post Bortezomib-based Mobilization|Yield of stem cell collection for the group that underwent bortezomib-based Mobilization
723138|NCT00148317|O2|Outcome|Treatment Arm - Responses Prior to Mobilization|This is the overall best response rate (ORR, ≥PR, as measured by ≥50% reduction in M-protein) to DoVeD therapy from post-primary induction (pre-DoVeD).
723139|NCT00148317|O1|Outcome|Treatment Arm - Post Mobilization|This is the response rate assessed for patients after their bortezomib-based mobilization.
723140|NCT00148317|E1|Reported Event|Treatment Arm (All Patients)|Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
723141|NCT00148122|B1|Baseline|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
723174|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723175|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723863|NCT00146172|O2|Outcome|Neratinib 80 mg|Neratinib 80 mg qd
723142|NCT00148122|P1|Participant Flow|Docetaxel and Capecitabine|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
723143|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
723144|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
723145|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
723146|NCT00148122|E1|Reported Event|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
723147|NCT00148109|B3|Baseline|Total|Total of all reporting groups
723148|NCT00148109|B2|Baseline|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
723149|NCT00148109|B1|Baseline|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
723150|NCT00148109|P2|Participant Flow|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
723151|NCT00148109|P1|Participant Flow|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
723152|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
723153|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
723154|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
723155|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
723156|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
723157|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
723158|NCT00148109|E2|Reported Event|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
723159|NCT00148109|E1|Reported Event|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
723160|NCT00147966|B1|Baseline|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
723161|NCT00147966|P1|Participant Flow|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
723162|NCT00147966|O1|Outcome|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
723163|NCT00147966|E1|Reported Event|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
723164|NCT00147823|B3|Baseline|Total|Total of all reporting groups
723165|NCT00147823|B2|Baseline|Vitoss Only|Vitoss: Synthetic bone graft material alone
723166|NCT00147823|B1|Baseline|Vitoss Used With Bone Marrow Aspirate|Vitoss: Synthetic bone graft material mixed with Bone Marrow aspirate
723167|NCT00147823|P2|Participant Flow|Vitoss With Bone Marrow Aspirate|"Addition of Vitoss to the bone marrow aspirate~Vitoss : Synthetic bone graft material"
723168|NCT00147823|P1|Participant Flow|Vitoss Alone|No bone marrow aspirate used
723169|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723170|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723171|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723172|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723173|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723864|NCT00146172|O1|Outcome|Neratinib 40 mg|Neratinb 40 mg qd
723176|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723177|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723178|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723179|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723180|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723181|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723182|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723183|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723184|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723185|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723186|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723187|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723188|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723189|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723190|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723191|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
723192|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
723193|NCT00147823|E2|Reported Event|Vitoss With Bone Marrow Aspirate|subjects who received Vitoss with bone marrow aspirate
723194|NCT00147823|E1|Reported Event|Vitoss Without Bone Marrow Aspirate|subjects who received Vitoss without bone marrow aspirate
723195|NCT00147745|B4|Baseline|Total|Total of all reporting groups
723196|NCT00147745|B3|Baseline|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
723197|NCT00147745|B2|Baseline|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
723198|NCT00147745|B1|Baseline|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723199|NCT00147745|P3|Participant Flow|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
723200|NCT00147745|P2|Participant Flow|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
723201|NCT00147745|P1|Participant Flow|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723202|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723203|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
723204|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
723205|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723206|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
723207|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
723208|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723209|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
723210|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
723211|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723212|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
723213|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
723214|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723215|NCT00147745|E3|Reported Event|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
723216|NCT00147745|E2|Reported Event|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
723217|NCT00147745|E1|Reported Event|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
723218|NCT00147537|B5|Baseline|Total|Total of all reporting groups
723219|NCT00147537|B4|Baseline|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723220|NCT00147537|B3|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723221|NCT00147537|B2|Baseline|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723222|NCT00147537|B1|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723223|NCT00147537|P11|Participant Flow|Paclitaxel(P)+Carboplatin(C) (Phase 2)|Paclitaxel (P) 200 mg/square meter (m^2) IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723224|NCT00147537|P10|Participant Flow|CP-751,871(F)+Paclitaxel(P)+Carboplatin(C) (Phase 2)|Single intravenous (IV) dose of CP‑751,871 (F) 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel (P) 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723225|NCT00147537|P9|Participant Flow|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723226|NCT00147537|P8|Participant Flow|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723227|NCT00147537|P7|Participant Flow|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723228|NCT00147537|P6|Participant Flow|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723229|NCT00147537|P5|Participant Flow|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723230|NCT00147537|P4|Participant Flow|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723231|NCT00147537|P3|Participant Flow|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723232|NCT00147537|P2|Participant Flow|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723233|NCT00147537|P1|Participant Flow|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723234|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723235|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723236|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723237|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723449|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
724720|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
723238|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723239|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723240|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723241|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723242|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723243|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723244|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723245|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723246|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723247|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723248|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723249|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723250|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723251|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723252|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723253|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723254|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723400|NCT00147537|E11|Reported Event|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723255|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723256|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723257|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723258|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723259|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723260|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
723261|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723262|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723263|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723264|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723265|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723266|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723267|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723268|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723425|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723426|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723546|NCT00147225|B7|Baseline|Total|Total of all reporting groups
723269|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723270|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723271|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723272|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723273|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723274|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723275|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723276|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723277|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723278|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723279|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723280|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723281|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723427|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723428|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723665|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
723282|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723283|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723284|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723285|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723286|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723287|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723288|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723289|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723290|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723291|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723292|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723293|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter (mg/mL), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723294|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723429|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723430|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723666|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
723295|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723296|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723297|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723298|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723299|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723300|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723301|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723302|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723303|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723304|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723305|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723306|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723307|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723431|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723432|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723433|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723308|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723309|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723310|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723311|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723312|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723313|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723314|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723315|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723316|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723317|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723318|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723319|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723320|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723434|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723435|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
727062|NCT00134901|B1|Baseline|Memantine|Memantine 40mg/day
723321|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723322|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723323|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723324|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723325|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723326|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723327|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723328|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723329|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723330|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723331|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723332|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723333|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723436|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723437|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723438|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723334|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723335|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723336|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723337|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723338|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723339|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723340|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723341|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723342|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723343|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723344|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723345|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723346|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723439|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723440|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723854|NCT00146172|O1|Outcome|Breast Cancer Cohort|Subjects with Breast Cancer
723347|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723348|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723349|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723350|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723351|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723352|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723353|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723354|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723355|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723356|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723357|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723358|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723359|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723441|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723442|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723855|NCT00146172|O3|Outcome|All Subjects|Subjects with Cancer
723360|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723361|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723362|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723363|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723364|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723365|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723366|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723367|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723368|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723369|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723370|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723371|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723372|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723443|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723444|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723445|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723373|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723374|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723375|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723376|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723377|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723378|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723379|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723380|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723381|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723382|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723383|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723384|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723385|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723446|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723447|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723448|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723386|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723387|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723388|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723389|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723390|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723391|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723392|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723393|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723394|NCT00147537|O1|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723395|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723396|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723397|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723398|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723399|NCT00147537|E12|Reported Event|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
723401|NCT00147537|E10|Reported Event|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723402|NCT00147537|E9|Reported Event|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723403|NCT00147537|E8|Reported Event|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723404|NCT00147537|E7|Reported Event|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723405|NCT00147537|E6|Reported Event|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723406|NCT00147537|E5|Reported Event|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723407|NCT00147537|E4|Reported Event|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723408|NCT00147537|E3|Reported Event|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723409|NCT00147537|E2|Reported Event|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723410|NCT00147537|E1|Reported Event|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
723411|NCT00147498|B5|Baseline|Total|Total of all reporting groups
723412|NCT00147498|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723413|NCT00147498|B3|Baseline|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723414|NCT00147498|B2|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723415|NCT00147498|B1|Baseline|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723416|NCT00147498|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723417|NCT00147498|P3|Participant Flow|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723418|NCT00147498|P2|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723419|NCT00147498|P1|Participant Flow|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723420|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723421|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723422|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723423|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723424|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723450|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723451|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723452|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723453|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723454|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723455|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723456|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723457|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723458|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723459|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723460|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723461|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723462|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723463|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723464|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723465|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723466|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723467|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723468|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723469|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723470|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723471|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723472|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723473|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723474|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723475|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723476|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723477|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723478|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723479|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723480|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723481|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723482|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723483|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723484|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723485|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723486|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723487|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723488|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723489|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723490|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723491|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723492|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723493|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723494|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723495|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723496|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723497|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723498|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723499|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723500|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723501|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723502|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723503|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723504|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723505|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723506|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723507|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723508|NCT00147498|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
723509|NCT00147498|E3|Reported Event|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
723510|NCT00147498|E2|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
723511|NCT00147498|E1|Reported Event|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
723512|NCT00147446|B3|Baseline|Total|Total of all reporting groups
723513|NCT00147446|B2|Baseline|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
723514|NCT00147446|B1|Baseline|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for multiple sclerosis(SMT-MS)at baseline
723515|NCT00147446|P2|Participant Flow|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
723516|NCT00147446|P1|Participant Flow|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
723517|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
723518|NCT00147446|O1|Outcome|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
723519|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control(WLC) provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
723520|NCT00147446|O1|Outcome|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
723521|NCT00147446|E2|Reported Event|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
723522|NCT00147446|E1|Reported Event|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS, provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
723523|NCT00147316|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
723524|NCT00147316|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
723525|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
723526|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
723527|NCT00147316|E1|Reported Event|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
723528|NCT00147290|B3|Baseline|Total|Total of all reporting groups
723529|NCT00147290|B2|Baseline|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
723530|NCT00147290|B1|Baseline|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
723531|NCT00147290|P2|Participant Flow|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
723532|NCT00147290|P1|Participant Flow|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
723533|NCT00147290|O2|Outcome|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
723534|NCT00147290|O1|Outcome|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
723535|NCT00147277|B3|Baseline|Total|Total of all reporting groups
723536|NCT00147277|B2|Baseline|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
723537|NCT00147277|B1|Baseline|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
723538|NCT00147277|P2|Participant Flow|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
723539|NCT00147277|P1|Participant Flow|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
723540|NCT00147277|O2|Outcome|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
723541|NCT00147277|O1|Outcome|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
723542|NCT00147238|B1|Baseline|Ferumoxtran-10 MRI Contrast Agent|
723543|NCT00147238|P1|Participant Flow|Ferumoxtran-10 MRI Contrast Agent|
723544|NCT00147238|O1|Outcome|Ferumoxtran-10 MRI Contrast Agent|
723545|NCT00147238|E1|Reported Event|Ferumoxtran-10 MRI Contrast Agent|
723547|NCT00147225|B6|Baseline|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723548|NCT00147225|B5|Baseline|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723549|NCT00147225|B4|Baseline|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
723550|NCT00147225|B3|Baseline|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723551|NCT00147225|B2|Baseline|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723552|NCT00147225|B1|Baseline|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723553|NCT00147225|P6|Participant Flow|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
723554|NCT00147225|P5|Participant Flow|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
723555|NCT00147225|P4|Participant Flow|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
723556|NCT00147225|P3|Participant Flow|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
723557|NCT00147225|P2|Participant Flow|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
723558|NCT00147225|P1|Participant Flow|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~Adriamycin /Ifosfamide (AI) regimens [Adriamycin (Doxorubicin) 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2"
723559|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723560|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723561|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
723562|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723563|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723564|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723565|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723566|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723567|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
723568|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723569|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723570|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723571|NCT00147225|E6|Reported Event|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723572|NCT00147225|E5|Reported Event|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
723667|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
723573|NCT00147225|E4|Reported Event|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
723574|NCT00147225|E3|Reported Event|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723575|NCT00147225|E2|Reported Event|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723576|NCT00147225|E1|Reported Event|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
723577|NCT00147212|B1|Baseline|Trabectedin|Experimental arm treated with trabectedin (ET-743)
723578|NCT00147212|P1|Participant Flow|Trabectedin|Experimental arm treated with trabectedin (ET-743)
723579|NCT00147212|O1|Outcome|Trabectedin|Men with metastatic castration resistant prostate cancer (CRPC) treated with trabectedin
723580|NCT00147212|E1|Reported Event|Trabectedin|Experimental arm treated with trabectedin (ET-743)
723581|NCT00147199|B3|Baseline|Total|Total of all reporting groups
723582|NCT00147199|B2|Baseline|Placebo|Identical placebo inhalation solution
723583|NCT00147199|B1|Baseline|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723584|NCT00147199|P2|Participant Flow|Placebo|Identical placebo inhalation solution
723585|NCT00147199|P1|Participant Flow|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723586|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723587|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723588|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723589|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723590|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723591|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723592|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723593|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723594|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723595|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723596|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723597|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723598|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723599|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723600|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723601|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723602|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723603|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723604|NCT00147199|E2|Reported Event|Placebo|Identical placebo inhalation solution
723605|NCT00147199|E1|Reported Event|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
723606|NCT00147030|B3|Baseline|Total|Total of all reporting groups
723607|NCT00147030|B2|Baseline|Non-cooled|Standard intensive care
723608|NCT00147030|B1|Baseline|Cooled|Whole body mild induced hypothermia 72 hours, commencing by 6 hours of age followed by re-warming to normothermia.
723609|NCT00147030|P2|Participant Flow|Non-cooled|Standard intensive care at normothermia
723610|NCT00147030|P1|Participant Flow|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723611|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723612|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723613|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723614|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723615|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723616|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723617|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723618|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723619|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723668|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
723620|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723621|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723622|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723623|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723624|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723625|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723626|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723627|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723628|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723629|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723630|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723631|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723632|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
723633|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723634|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723635|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723636|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723637|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723638|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723639|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723640|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723641|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723642|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723643|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723644|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723645|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723646|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723647|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723648|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723649|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723650|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723651|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723652|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
723653|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
723654|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
723655|NCT00147030|E2|Reported Event|Non-cooled|Standard intensive care
723656|NCT00147030|E1|Reported Event|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
723657|NCT00146848|B4|Baseline|Total|Total of all reporting groups
723658|NCT00146848|B3|Baseline|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
723659|NCT00146848|B2|Baseline|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
723660|NCT00146848|B1|Baseline|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
723661|NCT00146848|P3|Participant Flow|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
723662|NCT00146848|P2|Participant Flow|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
723663|NCT00146848|P1|Participant Flow|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
723664|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
723670|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
723671|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
723672|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
723673|NCT00146848|E3|Reported Event|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
723674|NCT00146848|E2|Reported Event|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
723675|NCT00146848|E1|Reported Event|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
723676|NCT00146770|B3|Baseline|Total|Total of all reporting groups
723677|NCT00146770|B2|Baseline|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment.
723678|NCT00146770|B1|Baseline|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment.
723679|NCT00146770|P2|Participant Flow|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723680|NCT00146770|P1|Participant Flow|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723681|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723682|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723683|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723684|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723685|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723686|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723687|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723688|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723689|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723690|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723691|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723692|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723693|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
723694|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
723695|NCT00146770|E2|Reported Event|"Aldurazyme/|Aldurazyme***Check Title***"|"Aldurazyme/|Aldurazyme***Check Description***"
723696|NCT00146770|E1|Reported Event|"Placebo/|Aldurazyme***Check Title***"|"Placebo/|Aldurazyme***Check Description***"
723697|NCT00146757|B1|Baseline|Arms 1 and 2 Combined|
723698|NCT00146757|P2|Participant Flow|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
723699|NCT00146757|P1|Participant Flow|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
723700|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723701|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723702|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723703|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723704|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723705|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723706|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
723707|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
723708|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723709|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723710|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723711|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
723712|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
723713|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
723714|NCT00146757|E1|Reported Event|Aldurazyme ***Check Title***|Aldurazyme ***check title***
723715|NCT00146640|B3|Baseline|Total|Total of all reporting groups
723716|NCT00146640|B2|Baseline|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723717|NCT00146640|B1|Baseline|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723718|NCT00146640|P2|Participant Flow|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723719|NCT00146640|P1|Participant Flow|MR Prednisone|Participants received tablets containing modified-release (MR) prednisone (to achieve the appropriate dose of 3–10 milligrams [mg] prednisone per day) at bed time and placebo matching to immediate-release (IR) prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723720|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723721|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723722|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723723|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723724|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723725|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723726|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723727|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723728|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723729|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723856|NCT00146172|O2|Outcome|Lung Cancer Cohort|Subjects with Lung Cohort
723730|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723731|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723732|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723733|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723734|NCT00146640|O2|Outcome|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723735|NCT00146640|O1|Outcome|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723736|NCT00146640|E2|Reported Event|IR Prednisone|Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks.
723737|NCT00146640|E1|Reported Event|MR Prednisone|Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3–10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks.
723738|NCT00146328|B4|Baseline|Total|Total of all reporting groups
723739|NCT00146328|B3|Baseline|Group 3 (Tipranavir naïve Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 449 patients were categorized into Group 3. Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.
723740|NCT00146328|B2|Baseline|Group 2 (Highly Treatment Experienced Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 255 patients were categorized into Group 2. Group 2: Patients from 1182.51 who rolled over into 1182.17.
723741|NCT00146328|B1|Baseline|Group 1 (Patients With Varying Degrees of Treatment Experience|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 291 patients were categorized into Group 1. Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48.
723742|NCT00146328|P3|Participant Flow|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723743|NCT00146328|P2|Participant Flow|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723744|NCT00146328|P1|Participant Flow|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723745|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723746|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723747|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723748|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723749|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723750|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723751|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723752|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723753|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723754|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723857|NCT00146172|O1|Outcome|Breast Cancer Cohort|Subjects with Breast Cancer
723755|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723756|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723757|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723758|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723759|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723760|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723761|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723762|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723763|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723764|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723765|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723766|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723767|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723768|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723769|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723770|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723771|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723772|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723773|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723774|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723775|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723776|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723777|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723778|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723779|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723780|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723781|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723858|NCT00146172|O7|Outcome|Neratinib 400 mg|Neratinib 400 mg qd
723782|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723783|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723784|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723785|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723786|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723787|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723788|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723789|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723790|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723791|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723792|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723793|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723794|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723795|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723796|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723797|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723798|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723799|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723800|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723801|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723802|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723803|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723804|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723805|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723806|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723807|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723808|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723859|NCT00146172|O6|Outcome|Neratinib 320 mg|Neratinib 320 mg qd.
723809|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723810|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723811|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723812|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723813|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723814|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723815|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723816|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723817|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723818|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723819|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723820|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723821|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723822|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723823|NCT00146328|E3|Reported Event|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
723824|NCT00146328|E2|Reported Event|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
723825|NCT00146328|E1|Reported Event|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
723826|NCT00146172|B9|Baseline|Total|Total of all reporting groups
723827|NCT00146172|B8|Baseline|Neratinib MTD|Neratinib maximum tolerated dose (320 mg) from part 2.
723828|NCT00146172|B7|Baseline|Neratinib 400 mg|Neratinib 400 mg qd
723829|NCT00146172|B6|Baseline|Neratinib 320 mg|Neratinib 320 mg qd
723830|NCT00146172|B5|Baseline|Neratinib 240 mg|Neratinib 240 mg qd
723831|NCT00146172|B4|Baseline|Neratinib 180 mg|Neratinib 180 mg qd
723832|NCT00146172|B3|Baseline|Neratinib 120 mg|Neratinib 120 mg qd
723833|NCT00146172|B2|Baseline|Neratinib 80 mg|Neratinib 80 mg qd
723834|NCT00146172|B1|Baseline|Neratinib 40 mg|Neratinb 40 mg qd
723835|NCT00146172|P8|Participant Flow|Neratinib MTD|Neratinib maximum tolerated dose (320 mg).
723836|NCT00146172|P7|Participant Flow|Neratinib 400 mg|Neratinib 400 mg qd
723837|NCT00146172|P6|Participant Flow|Neratinib 320 mg|Neratinib 320 mg qd
723838|NCT00146172|P5|Participant Flow|Neratinib 240 mg|Neratinib 240 mg qd
723839|NCT00146172|P4|Participant Flow|Neratinib 180 mg|Neratinib 180 mg qd
723840|NCT00146172|P3|Participant Flow|Neratinib 120 mg|Neratinib 120 mg qd
723841|NCT00146172|P2|Participant Flow|Neratinib 80 mg|Neratinib 80 mg qd
723842|NCT00146172|P1|Participant Flow|Neratinib 40 mg|Neratinb 40 mg qd
723843|NCT00146172|O3|Outcome|All Solid Tumors|Subjects with solid tumors in all doses of Neratinib
723844|NCT00146172|O2|Outcome|Lung Cancer|Subjects with Lung cancer in all doses of Neratinib
723845|NCT00146172|O1|Outcome|Breast Cancer|Subjects with breast cancer in all doses of neratinib
723846|NCT00146172|O3|Outcome|All Solid Tumors|Subjects with solid tumors in all doses of Neratinib
723847|NCT00146172|O2|Outcome|Lung Cancer|Subjects with Lung cancer in all doses of Neratinib
723848|NCT00146172|O1|Outcome|Breast Cancer|Subjects with breast cancer in all doses of neratinib
723849|NCT00146172|O3|Outcome|All Subjects|Subjects with Cancer
723850|NCT00146172|O2|Outcome|Lung Cancer Cohort|Subjects with Lung Cohort
723851|NCT00146172|O1|Outcome|Breast Cancer Cohort|Subjects with Breast Cancer
723852|NCT00146172|O3|Outcome|All Subjects|Subjects with Cancer
723853|NCT00146172|O2|Outcome|Lung Cancer Cohort|Subjects with Lung Cohort
723865|NCT00146172|E8|Reported Event|Neratinib MTD|Neratinib maximum tolerated dose (320 mg).
723866|NCT00146172|E7|Reported Event|Neratinib 400 mg|Neratinib 400 mg qd
723867|NCT00146172|E6|Reported Event|Neratinib 320 mg|Neratinib 320 mg qd
723868|NCT00146172|E5|Reported Event|Neratinib 240 mg|Neratinib 240 mg qd
723869|NCT00146172|E4|Reported Event|Neratinib 180 mg|Neratinib 180 mg qd
723870|NCT00146172|E3|Reported Event|Neratinib 120 mg|Neratinib 120 mg qd
723871|NCT00146172|E2|Reported Event|Neratinib 80 mg|Neratinib 80 mg qd
723872|NCT00146172|E1|Reported Event|Neratinib 40 mg|Neratinb 40 mg qd
723873|NCT00145795|B3|Baseline|Total|Total of all reporting groups
723874|NCT00145795|B2|Baseline|Current Regimen|Patients in this study arm continued their current regimen.
723875|NCT00145795|B1|Baseline|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723876|NCT00145795|P2|Participant Flow|Current Regimen|Patients in this study arm continued their current regimen.
723877|NCT00145795|P1|Participant Flow|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723878|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723879|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723880|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723881|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723882|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723883|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723884|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723885|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723886|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723887|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723888|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723889|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723890|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723891|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723892|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723893|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723894|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723895|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723896|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
723897|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723898|NCT00145795|E2|Reported Event|Current Regimen|Patients in this study arm continued their current regimen.
723899|NCT00145795|E1|Reported Event|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
723900|NCT00145704|B3|Baseline|Total|Total of all reporting groups
723901|NCT00145704|B2|Baseline|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
723902|NCT00145704|B1|Baseline|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
723903|NCT00145704|P2|Participant Flow|Growth Hormone Only|Growth hormone only, no bisphosphonate will be used
723904|NCT00145704|P1|Participant Flow|Bisphosphonate and Growth Hormone|bisphosphonate use and growth hormone use
723905|NCT00145704|O2|Outcome|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
723906|NCT00145704|O1|Outcome|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
723907|NCT00145704|E2|Reported Event|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
723908|NCT00145704|E1|Reported Event|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
723909|NCT00145626|B3|Baseline|Total|Total of all reporting groups
723910|NCT00145626|B2|Baseline|Expired|"Those participants who did not survive to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723911|NCT00145626|B1|Baseline|Alive|"Group of participants who survived to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723912|NCT00145626|P1|Participant Flow|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723913|NCT00145626|O8|Outcome|4-5 Years After HSCT|Study participants as previously described.
723914|NCT00145626|O7|Outcome|3-4 Years After HSCT|Study participants as previously described.
723915|NCT00145626|O6|Outcome|2-3 Years After HSCT|Study participants as previously described.
723916|NCT00145626|O5|Outcome|1-2 Years After HSCT|Study participants as previously described.
723917|NCT00145626|O4|Outcome|9-12 Months After HSCT|Study participants as previously described.
723918|NCT00145626|O3|Outcome|6-9 Months After HSCT|Study participants as previously described.
723919|NCT00145626|O2|Outcome|3-6 Months After HSCT|Study participants as previously described.
723920|NCT00145626|O1|Outcome|0-3 Months After HSCT|Study participants as previously described.
723921|NCT00145626|O3|Outcome|Study Participants: 5 Years Post HSCT|All study participants as previously described.
723922|NCT00145626|O2|Outcome|Study Participants: 1 Year Post HSCT|All study participants as previously described.
723923|NCT00145626|O1|Outcome|Study Participants: Before HSCT|All study participants as previously described.
723924|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723925|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723926|NCT00145626|O3|Outcome|Study Participants|"MRD data were collected on four study participants. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723927|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
723928|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
723929|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723930|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
723931|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
723932|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723933|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
723934|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
723935|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723936|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
723937|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
723938|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723939|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
723940|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
723941|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723942|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
723943|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
724047|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
723944|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723945|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
723946|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
723947|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723948|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723949|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723950|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723951|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723952|NCT00145626|E1|Reported Event|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
723953|NCT00145600|B5|Baseline|Total|Total of all reporting groups
723954|NCT00145600|B4|Baseline|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
723955|NCT00145600|B3|Baseline|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
723956|NCT00145600|B2|Baseline|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
723957|NCT00145600|B1|Baseline|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
723958|NCT00145600|P4|Participant Flow|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
723959|NCT00145600|P3|Participant Flow|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
723960|NCT00145600|P2|Participant Flow|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
723961|NCT00145600|P1|Participant Flow|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
723962|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723963|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723964|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723965|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723966|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723967|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723968|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
727063|NCT00134901|P2|Participant Flow|Placebo|Placebo daily dose
723969|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723970|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723971|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723972|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723973|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723974|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723975|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723976|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723977|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723978|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723979|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723980|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723981|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723982|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723983|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723984|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723985|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723986|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723987|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723988|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723989|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723990|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723991|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723992|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723993|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723994|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723995|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
723996|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723997|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
723998|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
723999|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724000|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724001|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724002|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724003|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724004|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724005|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724006|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724007|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724008|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724009|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724010|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724011|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724012|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724013|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724014|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724015|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724016|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724017|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724018|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724019|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724020|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724021|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724022|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724023|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724024|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724025|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724026|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724027|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724028|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724029|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724030|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724031|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724032|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724033|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724034|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724035|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724036|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724037|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724038|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724039|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724040|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724041|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724042|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724043|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724044|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724045|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724046|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724048|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724049|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724050|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724051|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724052|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724053|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724054|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724055|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724056|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724057|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
724058|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724059|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
724060|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724061|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
724062|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724063|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
724064|NCT00145600|O4|Outcome|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
724065|NCT00145600|O3|Outcome|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
724066|NCT00145600|O2|Outcome|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
724067|NCT00145600|O1|Outcome|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
724068|NCT00145600|E4|Reported Event|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
724069|NCT00145600|E3|Reported Event|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
724070|NCT00145600|E2|Reported Event|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
724071|NCT00145600|E1|Reported Event|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
724072|NCT00145587|B3|Baseline|Total|Total of all reporting groups
724073|NCT00145587|B2|Baseline|Sibling|Genetic testing
724074|NCT00145587|B1|Baseline|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
724075|NCT00145587|P2|Participant Flow|Sibling|Genetic testing
724076|NCT00145587|P1|Participant Flow|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
724077|NCT00145587|O2|Outcome|Sibling|Genetic testing
724078|NCT00145587|O1|Outcome|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
724079|NCT00145587|E2|Reported Event|Sibling|Genetic testing
724080|NCT00145587|E1|Reported Event|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
724081|NCT00145574|B4|Baseline|Total|Total of all reporting groups
724082|NCT00145574|B3|Baseline|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724083|NCT00145574|B2|Baseline|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724084|NCT00145574|B1|Baseline|Placebo|Placebo similar to active
724085|NCT00145574|P3|Participant Flow|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724086|NCT00145574|P2|Participant Flow|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724087|NCT00145574|P1|Participant Flow|Placebo|Placebo similar to active
724088|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
724089|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
724090|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
724128|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724091|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
724092|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
724093|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
724094|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
724095|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
724096|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
724097|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
724098|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
724099|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
724100|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
724101|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
724102|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
724103|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
724104|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
724105|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
724106|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
724107|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
724108|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
724109|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
724110|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
724111|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
724112|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
724113|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
724114|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
724115|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
724116|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724117|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724118|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
724119|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724120|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724121|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
724122|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724123|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724124|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
724125|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724126|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724127|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
724129|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724130|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
724131|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724132|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724133|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
724134|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
724135|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
724136|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
724137|NCT00145574|E4|Reported Event|High Dose Colesevelam Open Label Extension|All participants of the Open Label Extension (weeks 8-26) took colesevelam 3.8 grams per day.
724138|NCT00145574|E3|Reported Event|High Dose Colesevelam Double Blind Period|High dose colesevelam 3.8 grams per day taken from day 1 to week 8.
724139|NCT00145574|E2|Reported Event|Low Dose Colesevelam Double Blind Period|Low dose colesevelam 1.9 grams per day taken from day 1 to week 8.
724140|NCT00145574|E1|Reported Event|Placebo Double Blind Period|Placebo taken from day 1 to week 8.
724141|NCT00145509|B3|Baseline|Total|Total of all reporting groups
724142|NCT00145509|B2|Baseline|Placebo|Placebo sublingually BID
724143|NCT00145509|B1|Baseline|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
724144|NCT00145509|P2|Participant Flow|Placebo|Placebo sublingually BID
724145|NCT00145509|P1|Participant Flow|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
724146|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
724147|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
724148|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
724149|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
724150|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
724151|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
724152|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
724153|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
724154|NCT00145509|E2|Reported Event|Placebo|Placebo sublingually BID
724155|NCT00145509|E1|Reported Event|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
724156|NCT00145496|B3|Baseline|Total|Total of all reporting groups
724157|NCT00145496|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
724158|NCT00145496|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
724159|NCT00145496|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
724160|NCT00145496|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
724161|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
724162|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
724163|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
724164|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
724165|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
724166|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
724167|NCT00145496|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
724168|NCT00145496|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
724169|NCT00145418|B1|Baseline|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
724170|NCT00145418|P1|Participant Flow|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. Oxaliplatin:85 mg/m2 on Days 1 and 15 every 28 days Docetaxel:30 mg/m2 on Days 1 and 8 every 28 days.Doses will be calculated using actual body weight unless in the investigators opinion it would be in the patient's best interest to use ideal body weight. Cycles will be repeated every 28 days for a maximum of 6 cycles.
724171|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
724172|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
724173|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
724174|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
724175|NCT00145418|E1|Reported Event|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
724176|NCT00145327|B4|Baseline|Total|Total of all reporting groups
724177|NCT00145327|B3|Baseline|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724178|NCT00145327|B2|Baseline|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724179|NCT00145327|B1|Baseline|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724180|NCT00145327|P3|Participant Flow|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724181|NCT00145327|P2|Participant Flow|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724234|NCT00145249|B4|Baseline|Total|Total of all reporting groups
724182|NCT00145327|P1|Participant Flow|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724183|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724184|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724185|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724186|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724187|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724188|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724189|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724190|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724191|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724192|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724193|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724194|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724195|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724196|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724197|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724198|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724199|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724200|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724201|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724202|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724203|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724204|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724205|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724206|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724207|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724208|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724209|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724210|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724211|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724212|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724213|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724214|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724215|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724216|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724217|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724218|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724219|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724220|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724221|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724222|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724223|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724224|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724225|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724226|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724227|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724228|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724229|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724230|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724231|NCT00145327|E3|Reported Event|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
724232|NCT00145327|E2|Reported Event|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
724233|NCT00145327|E1|Reported Event|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
724235|NCT00145249|B3|Baseline|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724236|NCT00145249|B2|Baseline|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724237|NCT00145249|B1|Baseline|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724238|NCT00145249|P3|Participant Flow|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724239|NCT00145249|P2|Participant Flow|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724240|NCT00145249|P1|Participant Flow|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724241|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724242|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724243|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724244|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724245|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724246|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724247|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724248|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724249|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724250|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724251|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724252|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724253|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724254|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724255|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724256|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724257|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724258|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724259|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724260|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724261|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724262|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724407|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724408|NCT00144339|O1|Outcome|Placebo|Once daily
724263|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724264|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724265|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724266|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724267|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724268|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724269|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724270|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724271|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724272|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724273|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724274|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724275|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724276|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724277|NCT00145249|E3|Reported Event|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
724278|NCT00145249|E2|Reported Event|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
724279|NCT00145249|E1|Reported Event|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
724280|NCT00145119|B1|Baseline|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
724281|NCT00145119|P1|Participant Flow|Patients|
724282|NCT00145119|O1|Outcome|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
724283|NCT00145119|E1|Reported Event|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction.
724284|NCT00145041|B1|Baseline|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
724285|NCT00145041|P1|Participant Flow|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
724286|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
724287|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
724288|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
724289|NCT00145041|E1|Reported Event|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
724290|NCT00144963|B1|Baseline|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
724291|NCT00144963|P1|Participant Flow|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
724292|NCT00144963|O1|Outcome|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
724293|NCT00144963|E1|Reported Event|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
724294|NCT00144781|B5|Baseline|Total|Total of all reporting groups
724295|NCT00144781|B4|Baseline|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724296|NCT00144781|B3|Baseline|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724297|NCT00144781|B2|Baseline|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
724298|NCT00144781|B1|Baseline|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
724299|NCT00144781|P4|Participant Flow|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724300|NCT00144781|P3|Participant Flow|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724301|NCT00144781|P2|Participant Flow|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
724302|NCT00144781|P1|Participant Flow|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
724303|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724304|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724305|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
724306|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
724307|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724308|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724309|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
724310|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
724311|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724312|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
724313|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
724314|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
724315|NCT00144781|E4|Reported Event|"Aldurazyme|Weekly|1.2 mg/kg***Check Title***"|"Aldurazyme|Weekly|1.2 mg/kg***Check Description***"
724316|NCT00144781|E3|Reported Event|"Aldurazyme|Weekly|0.58 mg/kg***Check Title***"|"Aldurazyme|Weekly|0.58 mg/kg***Check Description***"
724317|NCT00144781|E2|Reported Event|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Description***"
724318|NCT00144781|E1|Reported Event|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Description***"
724319|NCT00144391|B3|Baseline|Total|Total of all reporting groups
724320|NCT00144391|B2|Baseline|Placebo|"Placebo~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
724321|NCT00144391|B1|Baseline|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
724322|NCT00144391|P2|Participant Flow|Placebo|"Placebo~placebo gel- 2 pumps per thigh per day for 6 months"
724323|NCT00144391|P1|Participant Flow|Transdermal Testosterone Gel|Transdermal Testosterone gel- 2.0 mg per pump dose 2 pumps per thigh per day for 6 months
724324|NCT00144391|O2|Outcome|Placebo|"Placebo~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
724325|NCT00144391|O1|Outcome|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
724326|NCT00144391|E2|Reported Event|Placebo|"Placebo~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
724409|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724410|NCT00144339|O1|Outcome|Placebo|Once daily
724411|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724412|NCT00144339|O1|Outcome|Placebo|Once daily
724327|NCT00144391|E1|Reported Event|Transdermal Testosterone Gel|"2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months~Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months."
724328|NCT00144339|B3|Baseline|Total|Total of all reporting groups
724329|NCT00144339|B2|Baseline|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724330|NCT00144339|B1|Baseline|Placebo|Once daily
724331|NCT00144339|P2|Participant Flow|Tiotropium Bromide Inhalation Capsules 18 mcg|once daily
724332|NCT00144339|P1|Participant Flow|Placebo|once daily
724333|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724334|NCT00144339|O1|Outcome|Placebo|Once daily
724335|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724336|NCT00144339|O1|Outcome|Placebo|Once daily
724337|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724338|NCT00144339|O1|Outcome|Placebo|Once daily
724339|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724340|NCT00144339|O1|Outcome|Placebo|Once daily
724341|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724342|NCT00144339|O1|Outcome|Placebo|Once daily
724343|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724344|NCT00144339|O1|Outcome|Placebo|Once daily
724345|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724346|NCT00144339|O1|Outcome|Placebo|Once daily
724347|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724348|NCT00144339|O1|Outcome|Placebo|Once daily
724349|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724350|NCT00144339|O1|Outcome|Placebo|Once daily
724351|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724352|NCT00144339|O1|Outcome|Placebo|Once daily
724353|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724354|NCT00144339|O1|Outcome|Placebo|Once daily
724355|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724356|NCT00144339|O1|Outcome|Placebo|Once daily
724357|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724358|NCT00144339|O1|Outcome|Placebo|Once daily
724359|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724360|NCT00144339|O1|Outcome|Placebo|Once daily
724361|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724362|NCT00144339|O1|Outcome|Placebo|Once daily
724363|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724364|NCT00144339|O1|Outcome|Placebo|Once daily
724365|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724366|NCT00144339|O1|Outcome|Placebo|Once daily
724367|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724368|NCT00144339|O1|Outcome|Placebo|Once daily
724369|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724370|NCT00144339|O1|Outcome|Placebo|Once daily
724371|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724372|NCT00144339|O1|Outcome|Placebo|Once daily
724373|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724374|NCT00144339|O1|Outcome|Placebo|Once daily
724375|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724376|NCT00144339|O1|Outcome|Placebo|Once daily
724377|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724378|NCT00144339|O1|Outcome|Placebo|Once daily
724379|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724380|NCT00144339|O1|Outcome|Placebo|Once daily
724381|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724382|NCT00144339|O1|Outcome|Placebo|Once daily
724383|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724384|NCT00144339|O1|Outcome|Placebo|Once daily
724385|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724386|NCT00144339|O1|Outcome|Placebo|Once daily
724387|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724388|NCT00144339|O1|Outcome|Placebo|Once daily
724389|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724390|NCT00144339|O1|Outcome|Placebo|Once daily
724391|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724392|NCT00144339|O1|Outcome|Placebo|Once daily
724393|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724394|NCT00144339|O1|Outcome|Placebo|Once daily
724395|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724396|NCT00144339|O1|Outcome|Placebo|Once daily
724397|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724398|NCT00144339|O1|Outcome|Placebo|Once daily
724399|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724400|NCT00144339|O1|Outcome|Placebo|Once daily
724401|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724402|NCT00144339|O1|Outcome|Placebo|Once daily
724403|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724404|NCT00144339|O1|Outcome|Placebo|Once daily
724405|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724406|NCT00144339|O1|Outcome|Placebo|Once daily
724413|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724414|NCT00144339|O1|Outcome|Placebo|Once daily
724415|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724416|NCT00144339|O1|Outcome|Placebo|Once daily
724417|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724418|NCT00144339|O1|Outcome|Placebo|Once daily
724419|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724420|NCT00144339|O1|Outcome|Placebo|Once daily
724421|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724422|NCT00144339|O1|Outcome|Placebo|Once daily
724423|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724424|NCT00144339|O1|Outcome|Placebo|Once daily
724425|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724426|NCT00144339|O1|Outcome|Placebo|Once daily
724427|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724428|NCT00144339|O1|Outcome|Placebo|Once daily
724429|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724430|NCT00144339|O1|Outcome|Placebo|Once daily
724431|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724432|NCT00144339|O1|Outcome|Placebo|Once daily
724433|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724434|NCT00144339|O1|Outcome|Placebo|Once daily
724435|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724436|NCT00144339|O1|Outcome|Placebo|Once daily
724437|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724438|NCT00144339|O1|Outcome|Placebo|Once daily
724439|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724440|NCT00144339|O1|Outcome|Placebo|Once daily
724441|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724442|NCT00144339|O1|Outcome|Placebo|Once daily
724443|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724444|NCT00144339|O1|Outcome|Placebo|Once daily
724445|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724446|NCT00144339|O1|Outcome|Placebo|Once daily
724447|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724448|NCT00144339|O1|Outcome|Placebo|Once daily
724449|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724450|NCT00144339|O1|Outcome|Placebo|Once daily
724451|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724452|NCT00144339|O1|Outcome|Placebo|Once daily
724453|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724454|NCT00144339|O1|Outcome|Placebo|Once daily
724455|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724456|NCT00144339|O1|Outcome|Placebo|Once daily
724457|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724458|NCT00144339|O1|Outcome|Placebo|Once daily
724459|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724460|NCT00144339|O1|Outcome|Placebo|Once daily
724461|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724462|NCT00144339|O1|Outcome|Placebo|Once daily
724463|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724464|NCT00144339|O1|Outcome|Placebo|Once daily
724465|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724466|NCT00144339|O1|Outcome|Placebo|Once daily
724467|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724468|NCT00144339|O1|Outcome|Placebo|Once daily
724469|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724470|NCT00144339|O1|Outcome|Placebo|Once daily
724471|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724472|NCT00144339|O1|Outcome|Placebo|Once daily
724473|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724474|NCT00144339|O1|Outcome|Placebo|Once daily
724475|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724476|NCT00144339|O1|Outcome|Placebo|Once daily
724477|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724478|NCT00144339|O1|Outcome|Placebo|Once daily
724479|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724480|NCT00144339|O1|Outcome|Placebo|Once daily
724481|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724482|NCT00144339|O1|Outcome|Placebo|Once daily
724483|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724484|NCT00144339|O1|Outcome|Placebo|Once daily
724485|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724486|NCT00144339|O1|Outcome|Placebo|Once daily
724487|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724488|NCT00144339|O1|Outcome|Placebo|Once daily
724489|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724490|NCT00144339|O1|Outcome|Placebo|Once daily
724491|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724492|NCT00144339|O1|Outcome|Placebo|Once daily
724493|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724494|NCT00144339|O1|Outcome|Placebo|Once daily
724495|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724496|NCT00144339|O1|Outcome|Placebo|Once daily
724644|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724497|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724498|NCT00144339|O1|Outcome|Placebo|Once daily
724499|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724500|NCT00144339|O1|Outcome|Placebo|Once daily
724501|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724502|NCT00144339|O1|Outcome|Placebo|Once daily
724503|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724504|NCT00144339|O1|Outcome|Placebo|Once daily
724505|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724506|NCT00144339|O1|Outcome|Placebo|Once daily
724507|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724508|NCT00144339|O1|Outcome|Placebo|Once daily
724509|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724510|NCT00144339|O1|Outcome|Placebo|Once daily
724511|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724512|NCT00144339|O1|Outcome|Placebo|Once daily
724513|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724514|NCT00144339|O1|Outcome|Placebo|Once daily
724515|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724516|NCT00144339|O1|Outcome|Placebo|Once daily
724517|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724518|NCT00144339|O1|Outcome|Placebo|Once daily
724519|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724520|NCT00144339|O1|Outcome|Placebo|Once daily
724521|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724522|NCT00144339|O1|Outcome|Placebo|Once daily
724523|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724524|NCT00144339|O1|Outcome|Placebo|Once daily
724525|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724526|NCT00144339|O1|Outcome|Placebo|Once daily
724527|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724528|NCT00144339|O1|Outcome|Placebo|Once daily
724529|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724530|NCT00144339|O1|Outcome|Placebo|Once daily
724531|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724532|NCT00144339|O1|Outcome|Placebo|Once daily
724533|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724534|NCT00144339|O1|Outcome|Placebo|Once daily
724535|NCT00144339|E2|Reported Event|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
724536|NCT00144339|E1|Reported Event|Placebo|Once daily
724537|NCT00144300|B3|Baseline|Total|Total of all reporting groups
724538|NCT00144300|B2|Baseline|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724539|NCT00144300|B1|Baseline|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724540|NCT00144300|P2|Participant Flow|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724541|NCT00144300|P1|Participant Flow|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724542|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724543|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724544|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724545|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724546|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724547|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724548|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724549|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724550|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724551|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724552|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724553|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724554|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724555|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724556|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724557|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724558|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724559|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724560|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724561|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724562|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724563|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724564|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724565|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724566|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724567|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724568|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724569|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724570|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724571|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724572|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724573|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724574|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724575|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724576|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724577|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724578|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724579|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724580|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724581|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724582|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724583|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724584|NCT00144300|E2|Reported Event|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
724585|NCT00144300|E1|Reported Event|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
724586|NCT00144170|B3|Baseline|Total|Total of all reporting groups
724587|NCT00144170|B2|Baseline|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724588|NCT00144170|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724589|NCT00144170|P2|Participant Flow|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724590|NCT00144170|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724591|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724592|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724593|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724594|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724595|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724596|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724597|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724598|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724599|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724600|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724601|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724602|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724603|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724604|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724605|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724606|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724607|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724608|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724609|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724610|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724611|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724612|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724613|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724614|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724615|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724616|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724617|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724618|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724619|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724620|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724621|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724622|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724623|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724624|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724625|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724626|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724627|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724628|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724629|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724630|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724631|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724632|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724633|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724634|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724635|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724636|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724637|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724638|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724639|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724640|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724641|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724642|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724643|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724645|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724646|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724647|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724648|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724649|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724650|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724651|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724652|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724653|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724654|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724655|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724656|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724657|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724658|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724659|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724660|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724661|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724662|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724663|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724664|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724665|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724666|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724667|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724668|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724669|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724670|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724671|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724672|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724673|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724674|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724675|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724676|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724677|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724678|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724679|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724680|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724681|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724682|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724683|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724684|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724685|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724686|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724687|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724688|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724689|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724690|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724691|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724692|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724693|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724694|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724695|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724696|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724697|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724698|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724699|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724700|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724701|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724702|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724703|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724704|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724705|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724706|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724707|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724708|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724709|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724710|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724711|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724712|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724713|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724714|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724715|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724716|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724717|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724718|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724719|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724721|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724722|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724723|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724724|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724725|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724726|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724727|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724728|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724729|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724730|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724731|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724732|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724733|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724734|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724735|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724736|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724737|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724738|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724739|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724740|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724741|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724742|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724743|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724744|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724745|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724746|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724747|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724748|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724749|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724750|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724751|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724752|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724753|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724754|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724755|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724756|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724757|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724758|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724759|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724760|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724761|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724762|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724763|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724764|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724765|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724766|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724767|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724768|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724769|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724770|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724771|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724772|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724773|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724774|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724775|NCT00144170|E2|Reported Event|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
724776|NCT00144170|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|
724777|NCT00144027|B3|Baseline|Total|Total of all reporting groups
724778|NCT00144027|B2|Baseline|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
724779|NCT00144027|B1|Baseline|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
724780|NCT00144027|P2|Participant Flow|Antipsychotic Adherence Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
724781|NCT00144027|P1|Participant Flow|Control|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
724806|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724782|NCT00144027|O2|Outcome|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
724783|NCT00144027|O1|Outcome|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
724784|NCT00144027|E2|Reported Event|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
724785|NCT00144027|E1|Reported Event|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
724786|NCT00143845|B1|Baseline|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
724787|NCT00143845|P1|Participant Flow|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
724788|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
724789|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
724790|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
724791|NCT00143845|E1|Reported Event|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
724792|NCT00143819|B3|Baseline|Total|Total of all reporting groups
724793|NCT00143819|B2|Baseline|Bilateral Comparison Group 2|"bilateral comparison~Placebo Application: Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
724794|NCT00143819|B1|Baseline|Bilateral Comparison Group 1|"bilateral comparison~Neuroskin Forte: Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
724795|NCT00143819|P2|Participant Flow|2 (Left Side: Placebo; Right Side: Active)|"bilateral comparison~Subjects randomized to Group 2 applied placebo sprays to the left side of the body and Neuroskin Forte study drug sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
724796|NCT00143819|P1|Participant Flow|1 (Left Side: Active; Right Side: Placebo)|"bilateral comparison~Subjects randomized to Group 1 applied Neuroskin Forte study drug sprays to the left side of the body and placebo sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
724797|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724798|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724799|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724800|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724801|NCT00143819|O2|Outcome|Placebo Spray (Eczema Patients)|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
724802|NCT00143819|O1|Outcome|Neuroskin Forte Spray (Eczema Patients)|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724803|NCT00143819|O2|Outcome|Placebo Spray (Psoriasis Patients)|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724804|NCT00143819|O1|Outcome|Neuroskin Forte Spray (Psoriasis Patients)|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
724805|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
724854|NCT00143507|E2|Reported Event|Placebo|Patients received placebo twice daily.
724807|NCT00143819|E1|Reported Event|Bilateral Comparison: Neuroskin Forte Spray vs Placebo Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body and placebo spray to the other side of the body, 3 times a day (with optional 4th application), for 8 weeks."
724808|NCT00143598|B3|Baseline|Total|Total of all reporting groups
724809|NCT00143598|B2|Baseline|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
724810|NCT00143598|B1|Baseline|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
724811|NCT00143598|P2|Participant Flow|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
724812|NCT00143598|P1|Participant Flow|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
724813|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
724814|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
724815|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
724816|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
724817|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
724818|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
724819|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
724820|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
724821|NCT00143598|E2|Reported Event|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
724822|NCT00143598|E1|Reported Event|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
724823|NCT00143507|B3|Baseline|Total|Total of all reporting groups
724824|NCT00143507|B2|Baseline|Placebo|Patients received placebo twice daily.
724825|NCT00143507|B1|Baseline|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724826|NCT00143507|P2|Participant Flow|Placebo|Patients received placebo twice daily.
724827|NCT00143507|P1|Participant Flow|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724828|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724829|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724830|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724831|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724832|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724833|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724834|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724835|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724836|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724837|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724838|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724839|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724840|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724841|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724842|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724843|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724844|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724845|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724846|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724847|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724848|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724849|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724850|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724851|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724852|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
724853|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724855|NCT00143507|E1|Reported Event|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
724856|NCT00143455|B5|Baseline|Total|Total of all reporting groups
724857|NCT00143455|B4|Baseline|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724858|NCT00143455|B3|Baseline|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724859|NCT00143455|B2|Baseline|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724860|NCT00143455|B1|Baseline|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724861|NCT00143455|P4|Participant Flow|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724862|NCT00143455|P3|Participant Flow|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724863|NCT00143455|P2|Participant Flow|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724864|NCT00143455|P1|Participant Flow|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724865|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724866|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724867|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724868|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724869|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724870|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724871|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724872|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724873|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724874|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724875|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724876|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724877|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
725189|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
724878|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724879|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724880|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724881|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724882|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724883|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724884|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724885|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724886|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724887|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724888|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724889|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724890|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724891|NCT00143455|E4|Reported Event|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724892|NCT00143455|E3|Reported Event|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724893|NCT00143455|E2|Reported Event|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724894|NCT00143455|E1|Reported Event|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
724895|NCT00143403|B3|Baseline|Total|Total of all reporting groups
724896|NCT00143403|B2|Baseline|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724897|NCT00143403|B1|Baseline|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724898|NCT00143403|P2|Participant Flow|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724899|NCT00143403|P1|Participant Flow|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724900|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724901|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724902|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724903|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724904|NCT00143403|E2|Reported Event|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724905|NCT00143403|E1|Reported Event|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
724906|NCT00143390|B3|Baseline|Total|Total of all reporting groups
727064|NCT00134901|P1|Participant Flow|Memantine|Memantine 40mg/day
724907|NCT00143390|B2|Baseline|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724908|NCT00143390|B1|Baseline|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724909|NCT00143390|P2|Participant Flow|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724910|NCT00143390|P1|Participant Flow|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724911|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724912|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724913|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724914|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724915|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724916|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724917|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724918|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724919|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724920|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724921|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724922|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724923|NCT00143390|E2|Reported Event|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724924|NCT00143390|E1|Reported Event|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
724925|NCT00143312|B1|Baseline|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724926|NCT00143312|P1|Participant Flow|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724927|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724928|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724929|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724930|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724931|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724932|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724933|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724934|NCT00143312|E1|Reported Event|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
724935|NCT00143247|B1|Baseline|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724936|NCT00143247|P1|Participant Flow|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724937|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724938|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724939|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724940|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724941|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724942|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724943|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724944|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724945|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724946|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724947|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724948|NCT00143247|E1|Reported Event|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
724949|NCT00142935|B4|Baseline|Total|Total of all reporting groups
724950|NCT00142935|B3|Baseline|MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
724951|NCT00142935|B2|Baseline|MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
724952|NCT00142935|B1|Baseline|Pre-release MMT Initiation + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
724953|NCT00142935|P3|Participant Flow|MMT Referral Post Release|Participants assigned to this arm will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with Medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
724954|NCT00142935|P2|Participant Flow|MMT Referral Post Release + Payment|Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
724955|NCT00142935|P1|Participant Flow|Pre-release MMT Initiation + Referral Post Release + Payment|Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
724956|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
724957|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
724958|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
724959|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
724960|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
724961|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
724962|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
724963|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
724964|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
724965|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
724966|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
724967|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
724968|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
724969|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
724970|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
724971|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
724972|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
724973|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
724974|NCT00142935|E3|Reported Event|As Assigned: MMT Referral Post Release|"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.~Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews."
724975|NCT00142935|E2|Reported Event|As Assigned: MMT Referral Post Release + Payment|"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews."
724976|NCT00142935|E1|Reported Event|As Assigned: Pre-release MMT + Referral Post Release + Payment|"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews."
724977|NCT00142909|B3|Baseline|Total|Total of all reporting groups
724978|NCT00142909|B2|Baseline|Placebo|
724979|NCT00142909|B1|Baseline|Lofexidine|
724980|NCT00142909|P2|Participant Flow|Placebo|Participants will receive daily placebo and follow the same schedule as the active intervention for 12 weeks.
724981|NCT00142909|P1|Participant Flow|Lofexidine|"Lofexidine: Study medication~Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject."
724982|NCT00142909|O2|Outcome|Placebo|Placebo pill
724983|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
724984|NCT00142909|O2|Outcome|Placebo|Placebo pill
724985|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
724986|NCT00142909|O2|Outcome|Placebo|Placebo pill
724987|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
724988|NCT00142909|O2|Outcome|Placebo|Placebo pill
724989|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
724990|NCT00142909|O2|Outcome|Placebo|Placebo pill
724991|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
724992|NCT00142909|O2|Outcome|Placebo|Placebo pill
724993|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
724994|NCT00142909|E2|Reported Event|Placebo|Placebo pill
724995|NCT00142909|E1|Reported Event|Lofexidine|Lofexidine: Study medication
724996|NCT00142818|B5|Baseline|Total|Total of all reporting groups
724997|NCT00142818|B4|Baseline|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
724998|NCT00142818|B3|Baseline|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
724999|NCT00142818|B2|Baseline|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
725000|NCT00142818|B1|Baseline|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
725001|NCT00142818|P4|Participant Flow|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
725002|NCT00142818|P3|Participant Flow|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
725003|NCT00142818|P2|Participant Flow|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
725004|NCT00142818|P1|Participant Flow|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
725005|NCT00142818|O4|Outcome|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
725006|NCT00142818|O3|Outcome|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
725007|NCT00142818|O2|Outcome|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
725008|NCT00142818|O1|Outcome|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
725009|NCT00142818|E4|Reported Event|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
725010|NCT00142818|E3|Reported Event|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
725011|NCT00142818|E2|Reported Event|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
725012|NCT00142818|E1|Reported Event|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
725013|NCT00142792|B4|Baseline|Total|Total of all reporting groups
725014|NCT00142792|B3|Baseline|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725049|NCT00142415|B5|Baseline|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
725140|NCT00141921|P1|Participant Flow|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725015|NCT00142792|B2|Baseline|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725016|NCT00142792|B1|Baseline|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725017|NCT00142792|P3|Participant Flow|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725018|NCT00142792|P2|Participant Flow|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725019|NCT00142792|P1|Participant Flow|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725020|NCT00142792|O3|Outcome|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725021|NCT00142792|O2|Outcome|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725022|NCT00142792|O1|Outcome|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725023|NCT00142792|O3|Outcome|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725024|NCT00142792|O2|Outcome|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725050|NCT00142415|B4|Baseline|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
725051|NCT00142415|B3|Baseline|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
725025|NCT00142792|O1|Outcome|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725026|NCT00142792|E3|Reported Event|B. Sensory Stim|"Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725027|NCT00142792|E2|Reported Event|C. EMG-Triggered|"EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be rewarded with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level.~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725028|NCT00142792|E1|Reported Event|A. Cyclic Stim|"Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles."
725029|NCT00142597|B3|Baseline|Total|Total of all reporting groups
725030|NCT00142597|B2|Baseline|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725031|NCT00142597|B1|Baseline|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725032|NCT00142597|P2|Participant Flow|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725033|NCT00142597|P1|Participant Flow|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725034|NCT00142597|O2|Outcome|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725035|NCT00142597|O1|Outcome|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725036|NCT00142597|E2|Reported Event|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725037|NCT00142597|E1|Reported Event|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
725038|NCT00142506|B3|Baseline|Total|Total of all reporting groups
725039|NCT00142506|B2|Baseline|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
725052|NCT00142415|B2|Baseline|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
725186|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725040|NCT00142506|B1|Baseline|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
725041|NCT00142506|P2|Participant Flow|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
725042|NCT00142506|P1|Participant Flow|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
725043|NCT00142506|O2|Outcome|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
725044|NCT00142506|O1|Outcome|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
725045|NCT00142506|E2|Reported Event|Placebo With Radiotherapy|"radiotherapy without hormones, questionaire assessments~placebo tablets & questionaires: Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.~In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months.~Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherap"
725046|NCT00142506|E1|Reported Event|Prophylactic Sildenafil Citrate With Radiotherapy|"radiotherapy with hormones, questionaire assessments~sildenafil citrate and questionaires: Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months.~Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24."
725047|NCT00142415|B7|Baseline|Total|Total of all reporting groups
725048|NCT00142415|B6|Baseline|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
727065|NCT00134901|O2|Outcome|Placebo|"Placebo~placebo: placebo"
725053|NCT00142415|B1|Baseline|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
725054|NCT00142415|P6|Participant Flow|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
725055|NCT00142415|P5|Participant Flow|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
725056|NCT00142415|P4|Participant Flow|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
725057|NCT00142415|P3|Participant Flow|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
725058|NCT00142415|P2|Participant Flow|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
725059|NCT00142415|P1|Participant Flow|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
725060|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
725061|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
725062|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
725063|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
725064|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
725065|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
725066|NCT00142415|O1|Outcome|Dosimetry Evaluable Analysis Set|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
725067|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
725068|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
725069|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
725070|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
725071|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
725072|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
725073|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
725138|NCT00142116|E1|Reported Event|All WM Patients|Waldenstrom's Macroglobulinemia Patients
725187|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725074|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
725075|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
725076|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
725077|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
725078|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
725079|NCT00142415|E7|Reported Event|Total|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
725080|NCT00142415|E6|Reported Event|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
725081|NCT00142415|E5|Reported Event|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
725082|NCT00142415|E4|Reported Event|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
725083|NCT00142415|E3|Reported Event|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
725084|NCT00142415|E2|Reported Event|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
725085|NCT00142415|E1|Reported Event|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
725086|NCT00142298|B11|Baseline|Total|Total of all reporting groups
725087|NCT00142298|B10|Baseline|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725088|NCT00142298|B9|Baseline|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725089|NCT00142298|B8|Baseline|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725090|NCT00142298|B7|Baseline|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725091|NCT00142298|B6|Baseline|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725092|NCT00142298|B5|Baseline|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725093|NCT00142298|B4|Baseline|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725094|NCT00142298|B3|Baseline|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725139|NCT00141921|B1|Baseline|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
727066|NCT00134901|O1|Outcome|Memantine|"Memantine~Memantine: Memantine"
725095|NCT00142298|B2|Baseline|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725096|NCT00142298|B1|Baseline|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725097|NCT00142298|P10|Participant Flow|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725098|NCT00142298|P9|Participant Flow|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725099|NCT00142298|P8|Participant Flow|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725100|NCT00142298|P7|Participant Flow|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725101|NCT00142298|P6|Participant Flow|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725102|NCT00142298|P5|Participant Flow|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725103|NCT00142298|P4|Participant Flow|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725104|NCT00142298|P3|Participant Flow|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725105|NCT00142298|P2|Participant Flow|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725106|NCT00142298|P1|Participant Flow|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725107|NCT00142298|O1|Outcome|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725108|NCT00142298|O2|Outcome|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725109|NCT00142298|O1|Outcome|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725110|NCT00142298|O1|Outcome|Group B : LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725111|NCT00142298|O1|Outcome|Group B : LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725112|NCT00142298|O3|Outcome|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725113|NCT00142298|O2|Outcome|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725188|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725114|NCT00142298|O1|Outcome|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725115|NCT00142298|O1|Outcome|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725116|NCT00142298|O1|Outcome|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725117|NCT00142298|E10|Reported Event|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725118|NCT00142298|E9|Reported Event|Group C: Lam Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725119|NCT00142298|E8|Reported Event|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
725120|NCT00142298|E7|Reported Event|Group B: Lam 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725121|NCT00142298|E6|Reported Event|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725122|NCT00142298|E5|Reported Event|Group A: Feeder 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725123|NCT00142298|E4|Reported Event|Group A: Feeder 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725124|NCT00142298|E3|Reported Event|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725125|NCT00142298|E2|Reported Event|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
725126|NCT00142298|E1|Reported Event|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
725127|NCT00142168|B1|Baseline|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
725128|NCT00142168|P1|Participant Flow|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
725129|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
725130|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
725131|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
725132|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
725133|NCT00142168|E1|Reported Event|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
725134|NCT00142116|B1|Baseline|All WM Patients|Waldenstrom's Macroglobulinemia Patients
725135|NCT00142116|P1|Participant Flow|All WM Patients|Waldenstrom's Macroglobulinemia Patients
725136|NCT00142116|O1|Outcome|Thalidomide and Rituximab|"Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks~Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.~Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.~Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later."
725137|NCT00142116|O1|Outcome|All WM Patients|Waldenstrom's Macroglobulinemia Patients
727067|NCT00134901|O2|Outcome|Placebo|Placebo daily dose
725141|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725142|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725143|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725144|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725145|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725146|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725147|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725148|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725149|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725150|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725151|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725152|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725153|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725154|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725155|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725156|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725157|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725158|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725159|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725160|NCT00141921|E1|Reported Event|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
725161|NCT00141817|B5|Baseline|Total|Total of all reporting groups
725162|NCT00141817|B4|Baseline|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725163|NCT00141817|B3|Baseline|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725164|NCT00141817|B2|Baseline|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725165|NCT00141817|B1|Baseline|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725166|NCT00141817|P4|Participant Flow|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725167|NCT00141817|P3|Participant Flow|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725168|NCT00141817|P2|Participant Flow|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725169|NCT00141817|P1|Participant Flow|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725170|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725171|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725172|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725173|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725174|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725175|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725176|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725177|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725178|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725179|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725180|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725181|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725182|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725183|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725184|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725185|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725190|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725191|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725192|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725193|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725194|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725195|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725196|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725197|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725198|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725199|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725200|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725201|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725202|NCT00141817|E4|Reported Event|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
725203|NCT00141817|E3|Reported Event|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
725204|NCT00141817|E2|Reported Event|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
725205|NCT00141817|E1|Reported Event|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
725206|NCT00141778|B4|Baseline|Total|Total of all reporting groups
725207|NCT00141778|B3|Baseline|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725208|NCT00141778|B2|Baseline|Ramipril|Angiotensin-converting enzyme inhibitor group
725209|NCT00141778|B1|Baseline|Placebo|Placebo Group
725210|NCT00141778|P3|Participant Flow|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist Group.Spironolactone was given as 25 mg/day.
725211|NCT00141778|P2|Participant Flow|Ramipril|Angiotensin-Converting Enzyme Inhibitor Group. Ramipril was given as 2.5 mg the first 3 days followed by 5 mg/day, with the dose reduced to 2.5 mg/day on the first postoperative day only.
725212|NCT00141778|P1|Participant Flow|Placebo|Placebo Group
725213|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725214|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725215|NCT00141778|O1|Outcome|Placebo|Placebo Group
725216|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725217|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725218|NCT00141778|O1|Outcome|Placebo|Placebo Group
725219|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725220|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725221|NCT00141778|O1|Outcome|Placebo|Placebo Group
725222|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725223|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725224|NCT00141778|O1|Outcome|Placebo|Placebo Group
725225|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725226|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725227|NCT00141778|O1|Outcome|Placebo|Placebo Group
725228|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725229|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725230|NCT00141778|O1|Outcome|Placebo|Placebo Group
725231|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725232|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725233|NCT00141778|O1|Outcome|Placebo|Placebo Group
725234|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725235|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725236|NCT00141778|O1|Outcome|Placebo|Placebo Group
725237|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725238|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725239|NCT00141778|O1|Outcome|Placebo|Placebo Group
725240|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725241|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725242|NCT00141778|O1|Outcome|Placebo|Placebo Group
725243|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725244|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
725245|NCT00141778|O1|Outcome|Placebo|Placebo Group
725246|NCT00141778|E3|Reported Event|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
725247|NCT00141778|E2|Reported Event|Ramipril|Angiotensin-converting enzyme inhibitor group
725248|NCT00141778|E1|Reported Event|Placebo|Placebo Group
725249|NCT00141765|B1|Baseline|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
725250|NCT00141765|P1|Participant Flow|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
725251|NCT00141765|O1|Outcome|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
725252|NCT00141765|E1|Reported Event|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
725253|NCT00141739|B1|Baseline|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725254|NCT00141739|P1|Participant Flow|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725255|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725256|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725257|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725258|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725259|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725260|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725261|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725262|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725263|NCT00141739|E1|Reported Event|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
725264|NCT00141726|B1|Baseline|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
725265|NCT00141726|P1|Participant Flow|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
725266|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
725267|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
725268|NCT00141726|E1|Reported Event|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
725269|NCT00141518|B4|Baseline|Total|Total of all reporting groups
725270|NCT00141518|B3|Baseline|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725271|NCT00141518|B2|Baseline|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725767|NCT00141271|P2|Participant Flow|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725272|NCT00141518|B1|Baseline|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725273|NCT00141518|P3|Participant Flow|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725274|NCT00141518|P2|Participant Flow|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725275|NCT00141518|P1|Participant Flow|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725276|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725277|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725278|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725279|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725280|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725281|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725282|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725283|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725284|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725285|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725768|NCT00141271|P1|Participant Flow|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725286|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725287|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725288|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725289|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725290|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725291|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725292|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725293|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725294|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725295|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725296|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725297|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725298|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725299|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725769|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725770|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725300|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725301|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725302|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725303|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725304|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725305|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725306|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725307|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725308|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725309|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725310|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725311|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725312|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725313|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725771|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725314|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725315|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725316|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725317|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725318|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725319|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725320|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725321|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725322|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725323|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725324|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725325|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725326|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725327|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725772|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
726104|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
725328|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725329|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725330|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725331|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725332|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725333|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725334|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725335|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725336|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725337|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725338|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725339|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725340|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725341|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725773|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
727068|NCT00134901|O1|Outcome|Memantine|Memantine 40mg/day
725342|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725343|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725344|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725345|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725346|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725347|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725348|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725349|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725350|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725351|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725352|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725353|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725354|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725355|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725774|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725356|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725357|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725358|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725359|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725360|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725361|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725362|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725363|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725364|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725365|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725366|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725367|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725368|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725369|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725775|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
726105|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
725370|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725371|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725372|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725373|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725374|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725375|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725376|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725377|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725378|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725379|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725380|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725381|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725382|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725383|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725776|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
727069|NCT00134901|E2|Reported Event|Placebo|Placebo daily dose
725384|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725385|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725386|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725387|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725388|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725389|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725390|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725391|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725392|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725393|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725394|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725395|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725396|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725397|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725777|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725398|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725399|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725400|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725401|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725402|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725403|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725404|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725405|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725406|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725407|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725408|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725409|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725410|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725411|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725778|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
726106|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
725412|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725413|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725414|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725415|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725416|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725417|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725418|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725419|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725420|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725421|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725422|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725423|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725424|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725425|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725779|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
727070|NCT00134901|E1|Reported Event|Memantine|Memantine 40mg/day
725426|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725427|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725428|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725429|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725430|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725431|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725432|NCT00141518|O1|Outcome|Total|Duodopa-naïve participants, Duodopa non-naïve participants treated with Duodopa for < 2 years, and Duodopa non-naïve participants treated with Duodopa for ≥ 2 years received Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725433|NCT00141518|O4|Outcome|Total|All participants
725434|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725435|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725436|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725437|NCT00141518|O4|Outcome|Total|All participants
725438|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725439|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725440|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725441|NCT00141518|O4|Outcome|Total|All participants
725488|NCT00141297|P1|Participant Flow|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
727071|NCT00134784|B5|Baseline|Total|Total of all reporting groups
725442|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725443|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725444|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725445|NCT00141518|O4|Outcome|Total|All participants
725446|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725447|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725448|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725449|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725450|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725451|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725452|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725453|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725454|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725455|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725456|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
726107|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
725457|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725458|NCT00141518|E3|Reported Event|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725459|NCT00141518|E2|Reported Event|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725460|NCT00141518|E1|Reported Event|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
725461|NCT00141453|B3|Baseline|Total|Total of all reporting groups
725462|NCT00141453|B2|Baseline|Placebo Comparator|Matching placebo tablets
725463|NCT00141453|B1|Baseline|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
725464|NCT00141453|P2|Participant Flow|Placebo Comparator|Matching placebo tablets
725465|NCT00141453|P1|Participant Flow|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
725466|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
725467|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
725468|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
725469|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
725470|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
725471|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
725472|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
725473|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
725474|NCT00141453|E2|Reported Event|Placebo Comparator|Matching placebo tablets
725475|NCT00141453|E1|Reported Event|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
725476|NCT00141297|B3|Baseline|Total|Total of all reporting groups
725477|NCT00141297|B2|Baseline|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725478|NCT00141297|B1|Baseline|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725479|NCT00141297|P10|Participant Flow|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725480|NCT00141297|P9|Participant Flow|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725481|NCT00141297|P8|Participant Flow|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725482|NCT00141297|P7|Participant Flow|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725483|NCT00141297|P6|Participant Flow|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725484|NCT00141297|P5|Participant Flow|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725485|NCT00141297|P4|Participant Flow|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725486|NCT00141297|P3|Participant Flow|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725487|NCT00141297|P2|Participant Flow|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
734097|NCT00114517|B1|Baseline|Early Postmenopause 17B-estradiol|
725489|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725490|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725491|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725492|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725493|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725494|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725495|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725496|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725497|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725498|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725499|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725500|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725501|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725502|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725503|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725504|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725505|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725506|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725507|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725508|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725509|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725510|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725511|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725512|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
726432|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
725513|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725514|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725515|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725516|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725517|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725518|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725519|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725520|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725521|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725522|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725523|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725524|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725525|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725526|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725527|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725528|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725529|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725530|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725531|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725532|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725533|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725534|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725535|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725536|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
726433|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
725537|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725538|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725539|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725540|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725541|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725542|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725543|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725544|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725545|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725546|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725547|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725548|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725549|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725550|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725551|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725552|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725553|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725554|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725555|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725556|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725557|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725558|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
726434|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
725559|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725560|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725561|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725562|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725563|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725564|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725565|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725566|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725567|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725568|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725569|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725570|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725571|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725572|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725573|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725574|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725575|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725576|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725577|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725578|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725579|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725580|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
726435|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
725581|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725582|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725583|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725584|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725585|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725586|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725587|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725588|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725589|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725590|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725591|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725592|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725593|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725594|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725595|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725596|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725597|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725598|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725599|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725600|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725601|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725602|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725780|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725603|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725604|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725605|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725606|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725607|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725608|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725609|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725610|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725611|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725612|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725613|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725614|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725615|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725616|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725617|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725618|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725619|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725620|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725621|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725622|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725623|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725624|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725646|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725625|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725626|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725627|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725628|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725629|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725630|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725631|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725632|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725633|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725634|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725635|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725636|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725637|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725638|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725639|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725640|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725641|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725642|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725643|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725644|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725645|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725763|NCT00141271|B3|Baseline|Placebo|Subjects were assigned to placebo
725781|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725647|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725648|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725649|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725650|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725651|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725652|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725653|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725654|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725655|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725656|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725657|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725658|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725659|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725660|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725661|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725662|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725663|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725664|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725665|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725666|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725667|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725668|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725764|NCT00141271|B2|Baseline|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725669|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725670|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725671|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725672|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725673|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725674|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725675|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725676|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725677|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725678|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725679|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725680|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725681|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725682|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725683|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725684|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725685|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725686|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725687|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725688|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725689|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725690|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725765|NCT00141271|B1|Baseline|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725766|NCT00141271|P3|Participant Flow|Placebo|Subjects were assigned to placebo
725691|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725692|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725693|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725694|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725695|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725696|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725697|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725698|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725699|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725700|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725701|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725702|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725703|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725704|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725705|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725706|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725707|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725708|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725709|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725710|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725711|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725712|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725713|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725714|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725715|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725716|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725717|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725718|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725719|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725720|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725721|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725722|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725723|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725724|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725725|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725726|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725727|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725728|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725729|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725730|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725731|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725732|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725733|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725734|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725735|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725736|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725737|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725738|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725739|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725740|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725741|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725742|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725743|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725744|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725745|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725746|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725747|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725748|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725749|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725750|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725751|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725752|NCT00141297|E10|Reported Event|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725753|NCT00141297|E9|Reported Event|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725754|NCT00141297|E8|Reported Event|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725755|NCT00141297|E7|Reported Event|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725756|NCT00141297|E6|Reported Event|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725757|NCT00141297|E5|Reported Event|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725758|NCT00141297|E4|Reported Event|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725759|NCT00141297|E3|Reported Event|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725760|NCT00141297|E2|Reported Event|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725761|NCT00141297|E1|Reported Event|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
725762|NCT00141271|B4|Baseline|Total|Total of all reporting groups
725782|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725783|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725784|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725785|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725786|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725787|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725788|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725789|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725790|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725791|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725792|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725793|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725794|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725795|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725796|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725797|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725798|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725799|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725800|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725801|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725802|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725803|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725804|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725805|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725806|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725807|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725808|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725809|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725810|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725811|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725812|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725813|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725814|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725815|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725816|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725817|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725818|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725819|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725820|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725821|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725822|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725823|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725824|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725825|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725826|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725827|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725828|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725829|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725830|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725831|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725832|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725833|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725834|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725835|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725836|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725837|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725838|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725839|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725840|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725841|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725842|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725843|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725844|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725845|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725846|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725847|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725848|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725849|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725850|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725851|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725852|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725853|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725854|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725855|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725856|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725857|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725858|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725859|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725860|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725861|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725862|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725863|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725864|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725865|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725866|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725867|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725868|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725869|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725870|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725871|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725872|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725873|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725874|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725875|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725876|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725877|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725878|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725879|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725880|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
725881|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725882|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725883|NCT00141271|E3|Reported Event|Placebo|Subjects were assigned to placebo
725884|NCT00141271|E2|Reported Event|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
725885|NCT00141271|E1|Reported Event|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
725886|NCT00141219|B3|Baseline|Total|Total of all reporting groups
725887|NCT00141219|B2|Baseline|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725888|NCT00141219|B1|Baseline|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725889|NCT00141219|P2|Participant Flow|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725890|NCT00141219|P1|Participant Flow|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725891|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725892|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725893|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725894|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725895|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725896|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725897|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725898|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725899|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725900|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725901|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725902|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725903|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725904|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725905|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725906|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725907|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725908|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725909|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725910|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725911|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725912|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725913|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725914|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725915|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
735268|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
725916|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725917|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725918|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725919|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725920|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725921|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725922|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725923|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725924|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725925|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725926|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725927|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725928|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725929|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725930|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725931|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725932|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725933|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725934|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725935|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725936|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725937|NCT00141219|E2|Reported Event|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
725938|NCT00141219|E1|Reported Event|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
725939|NCT00141115|B1|Baseline|Levetiracetam|Levetiracetam 1500 mg BID
725940|NCT00141115|P1|Participant Flow|Levetiracetam|Levetiracetam 1500 mg BID
725941|NCT00141115|O1|Outcome|Levetiracetam 1500 mg Twice Daily|Levitiracetam 1500 mg administered twice daily under open-label conditions.
725942|NCT00141115|E1|Reported Event|Levetiracetam 1500 mg Twice Daily|Levitiracetam 1500 mg administered twice daily under open label conditions.
725943|NCT00141102|B3|Baseline|Total|Total of all reporting groups
725944|NCT00141102|B2|Baseline|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
725945|NCT00141102|B1|Baseline|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725946|NCT00141102|P2|Participant Flow|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725947|NCT00141102|P1|Participant Flow|Celecoxib|200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo
725948|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725949|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725950|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725951|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725952|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725953|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725954|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725955|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725956|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
725957|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725958|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725959|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725960|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
725961|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725962|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725963|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725964|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725965|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725966|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725967|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725968|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
725969|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725970|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725971|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725972|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725973|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725974|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725975|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725976|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725977|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725978|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725979|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725980|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725981|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725982|NCT00141102|E2|Reported Event|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
725983|NCT00141102|E1|Reported Event|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
725984|NCT00141037|B3|Baseline|Total|Total of all reporting groups
725985|NCT00141037|B2|Baseline|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725986|NCT00141037|B1|Baseline|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725987|NCT00141037|P2|Participant Flow|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725988|NCT00141037|P1|Participant Flow|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725989|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725990|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725991|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725992|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725993|NCT00141037|E2|Reported Event|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725994|NCT00141037|E1|Reported Event|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
725995|NCT00140842|B3|Baseline|Total|Total of all reporting groups
725996|NCT00140842|B2|Baseline|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
725997|NCT00140842|B1|Baseline|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
725998|NCT00140842|P2|Participant Flow|Obese Girls|Obese adolescents between 12–18 years old.
725999|NCT00140842|P1|Participant Flow|Normal-weight Girls|Normal weight girls 12-18 years old
726000|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
726001|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
726002|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
726003|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
726004|NCT00140842|E2|Reported Event|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
726005|NCT00140842|E1|Reported Event|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
726006|NCT00140621|B1|Baseline|Agalsidase Beta|Agalsidase beta 1 mg/kg intravenously once every 2 weeks up to 156 weeks.
726007|NCT00140621|P1|Participant Flow|Agalsidase Beta (Fabrazyme [Recombinant Form])|Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks.
726008|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726009|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726010|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726011|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726012|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726013|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726014|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726015|NCT00140621|E1|Reported Event|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
726016|NCT00140556|B1|Baseline|Entire Study Population|
726017|NCT00140556|P1|Participant Flow|Entire Study Population|
726018|NCT00140556|O1|Outcome|Entire Study Population|
726019|NCT00140556|E1|Reported Event|Entire Study Population|
726020|NCT00140426|B3|Baseline|Total|Total of all reporting groups
726021|NCT00140426|B2|Baseline|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726022|NCT00140426|B1|Baseline|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726023|NCT00140426|P2|Participant Flow|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726024|NCT00140426|P1|Participant Flow|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726025|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726026|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726027|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726028|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726029|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726030|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726031|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726032|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726033|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726034|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726035|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: this group of patients received the active study medication. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726036|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~This subject group received placebo tablets which appeared identical to risperidone"
726037|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726038|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726039|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726040|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726041|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726042|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726043|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726044|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726103|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
726045|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication.~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726046|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. This is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726047|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726048|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726049|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726050|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726051|NCT00140426|E2|Reported Event|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
726052|NCT00140426|E1|Reported Event|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
726053|NCT00140413|B4|Baseline|Total|Total of all reporting groups
726054|NCT00140413|B3|Baseline|Treatment Group 2: Control|Subjects with normal growth were randomized to treatment or to control (no intervention).
726055|NCT00140413|B2|Baseline|Treatment Group 1B: Randomized to GH|Subjects with normal growth were randomized to GH treatment or to control (no intervention).
726056|NCT00140413|B1|Baseline|Treatment Group 1A: Assigned to GH|Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care.
726057|NCT00140413|P2|Participant Flow|Treatment Group 2: Control|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however, control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.
726058|NCT00140413|P1|Participant Flow|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
726059|NCT00140413|O3|Outcome|Treatment Group 3: Control Crossed Over to Treatment|3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
726060|NCT00140413|O2|Outcome|Treatment Group 2: Control|"Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.~A total of 7 subjects were randomized to the control group, 3 of whom were crossed over to treatment due to growth deceleration. Outcome measures for these 3 who crossed over were analyzed separately, under Treatment Group 3."
726061|NCT00140413|O1|Outcome|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting daily dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
726062|NCT00140413|E2|Reported Event|Treatment Group 2: Control|The denominator below (# at risk) is based on the number of subjects in Group 2 who received at least one dose of growth hormone. Per protocol, control subjects received no intervention; however, 3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
726063|NCT00140413|E1|Reported Event|Treatment Group 1: Receiving Growth Hormone Treatment|The denominator below (# at risk) is based on the number of subjects in Group 1 who received at least one dose of growth hormone.
726064|NCT00140244|B1|Baseline|All Study Participants|"r-MetHuLeptin SubQ once daily~r-metHuLeptin/placebo then placebo/r-metHuLeptin"
726065|NCT00140244|P2|Participant Flow|Placebo First, Then r-metHuLeptin|Subcutaneously once daily Placebo first, then r-metHuLeptin both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726066|NCT00140244|P1|Participant Flow|r-MetHuLeptin First, Then Placebo|r-MetHuLeptin subcutaneously once daily first, then Placebo both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726067|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
736164|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
726068|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726069|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726070|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726071|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726072|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726073|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726074|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726075|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726076|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726077|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726078|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726079|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726080|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726081|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726082|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726083|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726084|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726085|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726086|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726087|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726088|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726089|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726090|NCT00140244|O1|Outcome|r-metHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726091|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726092|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
726093|NCT00140244|E2|Reported Event|Placebo|
726094|NCT00140244|E1|Reported Event|r-MetHuLeptin|
726095|NCT00140231|B3|Baseline|Total|Total of all reporting groups
726096|NCT00140231|B2|Baseline|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
726097|NCT00140231|B1|Baseline|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
726098|NCT00140231|P2|Participant Flow|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
726099|NCT00140231|P1|Participant Flow|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"Six young, healthy, and lean women (age, 22.8,; BMI,21.7kg/m2) who were eumenor- rheic were enrolled in a clinical researchcenter– based, randomized, cross-over interventional study involving three separate 5-day-long inpatient admissions (22). Six subjects with a cross-over design, enabling paired comparisons, would provide 80% power to detect a difference of 1.4 SD between different conditionsat the conventional~a=0.05 level. In thefirst admission, the subjects were studied in the isocaloric fed state, whereas in the following two admissions the subjects were studied in the prolonged fasting state for 72 h and were randomized to receive either placebo or metreleptin at replacement doses. A cross-over to the opposite arm took place in the later admission so that all six subjects received both placebo and metreleptin.~r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
726100|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
726101|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
726102|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
726108|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
726109|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
726110|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
726111|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
726112|NCT00140231|E2|Reported Event|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
726113|NCT00140231|E1|Reported Event|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
726114|NCT00140140|B4|Baseline|Total|Total of all reporting groups
726115|NCT00140140|B3|Baseline|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726116|NCT00140140|B2|Baseline|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726117|NCT00140140|B1|Baseline|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726118|NCT00140140|P3|Participant Flow|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726119|NCT00140140|P2|Participant Flow|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726120|NCT00140140|P1|Participant Flow|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726121|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726122|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726123|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726124|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726125|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726126|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726127|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726128|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726129|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726436|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726130|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726131|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726132|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726133|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726134|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726135|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726136|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726137|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726138|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726139|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726140|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726141|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726142|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726143|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726144|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726145|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726146|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726180|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
738740|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
726147|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726148|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726149|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726150|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726151|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726152|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
726153|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
726154|NCT00140140|E2|Reported Event|90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants are from study Part 2.
726155|NCT00140140|E1|Reported Event|80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants from study Parts 1 and 2 are combined.
726156|NCT00139997|B3|Baseline|Total|Total of all reporting groups
726157|NCT00139997|B2|Baseline|Inactive Intervention|Equivalent exposure to inactive negative ion generator
726158|NCT00139997|B1|Baseline|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
726159|NCT00139997|P2|Participant Flow|Inactive Intervention|Equivalent exposure to inactive negative ion generator
726160|NCT00139997|P1|Participant Flow|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
726161|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
726162|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
726163|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
726164|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
726165|NCT00139997|E2|Reported Event|Inactive Intervention|Equivalent exposure to inactive negative ion generator
726166|NCT00139997|E1|Reported Event|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
726167|NCT00139776|B3|Baseline|Total|Total of all reporting groups
726168|NCT00139776|B2|Baseline|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726169|NCT00139776|B1|Baseline|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726170|NCT00139776|P4|Participant Flow|Celecoxib 200mg Intermittent Use|Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726171|NCT00139776|P3|Participant Flow|Celecoxib 200mg Continuous Use|Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726172|NCT00139776|P2|Participant Flow|Open-Label Celecoxib Run-in Period|Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
726173|NCT00139776|P1|Participant Flow|Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories|Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
726174|NCT00139776|O1|Outcome|Celecoxib 200mg Open Label|Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS
726175|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726176|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726177|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726178|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726179|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726347|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726181|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726182|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726183|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726184|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726185|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726186|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726187|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726188|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726189|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726190|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726191|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726192|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726193|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726194|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726195|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726196|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726197|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726198|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726199|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726200|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726201|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726202|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726203|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726204|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726205|NCT00139776|E2|Reported Event|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
726206|NCT00139776|E1|Reported Event|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
726207|NCT00139737|B1|Baseline|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
726208|NCT00139737|P1|Participant Flow|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
726209|NCT00139737|O1|Outcome|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
726210|NCT00139737|E1|Reported Event|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
726211|NCT00139659|B3|Baseline|Total|Total of all reporting groups
726212|NCT00139659|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726213|NCT00139659|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726214|NCT00139659|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726215|NCT00139659|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726216|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726217|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726218|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726219|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726220|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726221|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726222|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726223|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726224|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726225|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726226|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726227|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726228|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726229|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726230|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726231|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726232|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726233|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726234|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726235|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726236|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726237|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726238|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726239|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726240|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726241|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726242|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726243|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726244|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726245|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726246|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726247|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726248|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726249|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726250|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726251|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726252|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726253|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726254|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726255|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726256|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726257|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726258|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726259|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726260|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726261|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726262|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726263|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726264|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726265|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726266|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726267|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726268|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726269|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726270|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726271|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726272|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726273|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726274|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726275|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726276|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726277|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726278|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726279|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726280|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726281|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726282|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726283|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726284|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726285|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726286|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726287|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726288|NCT00139659|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726289|NCT00139659|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726290|NCT00139477|B3|Baseline|Total|Total of all reporting groups
726291|NCT00139477|B2|Baseline|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
726292|NCT00139477|B1|Baseline|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
726293|NCT00139477|P2|Participant Flow|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
726294|NCT00139477|P1|Participant Flow|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
726295|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726296|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726297|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726298|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726299|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726300|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726301|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726302|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726303|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726304|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726305|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726306|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726307|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726308|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726309|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726310|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
726311|NCT00139477|E2|Reported Event|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
726312|NCT00139477|E1|Reported Event|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
726313|NCT00138671|B3|Baseline|Total|Total of all reporting groups
726314|NCT00138671|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726315|NCT00138671|B1|Baseline|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726316|NCT00138671|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726317|NCT00138671|P1|Participant Flow|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726318|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726319|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726320|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726321|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726322|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726323|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726324|NCT00138671|O2|Outcome|Subcutaneous Insulin|
726325|NCT00138671|O1|Outcome|Inhaled Insulin|
726326|NCT00138671|O2|Outcome|Subcutaneous Insulin|
726327|NCT00138671|O1|Outcome|Inhaled Insulin|
726328|NCT00138671|O2|Outcome|Subcutaneous Insulin|
726329|NCT00138671|O1|Outcome|Inhaled Insulin|
726330|NCT00138671|O2|Outcome|Subcutaneous Insulin|
726331|NCT00138671|O1|Outcome|Inhaled Insulin|
726332|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726333|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726334|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726335|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726336|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726337|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726338|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726339|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726340|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726341|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726342|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726343|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726344|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726345|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726346|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726429|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726348|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726349|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726350|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726351|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726352|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726353|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726354|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726355|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726356|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726357|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726358|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726359|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726360|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726361|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726362|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726363|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726364|NCT00138671|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726365|NCT00138671|E1|Reported Event|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726366|NCT00138658|B1|Baseline|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
726367|NCT00138658|P1|Participant Flow|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
726368|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
726369|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
726370|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
726371|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
726372|NCT00138658|O1|Outcome|Mean Reduction in Serum Clusterin From Baseline|The mean reduction in serum clusterin was calculated by determining the difference from baseline to the minimum post baseline level. The reduction in serum clusterin was determined for all subjects who had baseline and at least one post-baseline serum clusterin assessment (n=55).
726373|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
726430|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726431|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726374|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
726375|NCT00138658|E1|Reported Event|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
726376|NCT00138645|B3|Baseline|Total|Total of all reporting groups
726377|NCT00138645|B2|Baseline|Healthy Diet|Healthy Diet
726378|NCT00138645|B1|Baseline|MicroDiet|MicroDiet
726379|NCT00138645|P2|Participant Flow|Healthy Diet|Healthy Diet
726380|NCT00138645|P1|Participant Flow|MicroDiet|MicroDiet
726381|NCT00138645|O2|Outcome|Healthy Diet|Healthy Diet
726382|NCT00138645|O1|Outcome|MicroDiet|MicroDiet
726383|NCT00138645|E2|Reported Event|Healthy Diet|participants randomized to the low-calorie diet.
726384|NCT00138645|E1|Reported Event|MicroDiet|Participants randomized to the MicroDiet
726385|NCT00138424|B5|Baseline|Total|Total of all reporting groups
726386|NCT00138424|B4|Baseline|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726387|NCT00138424|B3|Baseline|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726388|NCT00138424|B2|Baseline|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726389|NCT00138424|B1|Baseline|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726390|NCT00138424|P4|Participant Flow|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726391|NCT00138424|P3|Participant Flow|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726392|NCT00138424|P2|Participant Flow|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726393|NCT00138424|P1|Participant Flow|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726394|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
726395|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
726396|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
726397|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
726398|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726399|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726400|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726401|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726402|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726403|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726404|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726405|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726406|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726407|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726408|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726409|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726410|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726411|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726412|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726413|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726414|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726415|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726416|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726417|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726418|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726419|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726420|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726421|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726422|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726423|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726424|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726425|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726426|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726427|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726428|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726437|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726438|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726439|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726440|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726441|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726442|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726443|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726444|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726445|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726446|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726447|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726448|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726449|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726450|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726451|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726452|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726453|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726454|NCT00138424|E4|Reported Event|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726455|NCT00138424|E3|Reported Event|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
726456|NCT00138424|E2|Reported Event|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726457|NCT00138424|E1|Reported Event|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
726458|NCT00138294|B1|Baseline|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
726459|NCT00138294|P1|Participant Flow|Intervention Cities|Eligible children 4 years of age and older whose parents provided consent (assent for children>7 years) in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
726460|NCT00138294|O1|Outcome|Influenza Vaccine|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Serious adverse events (SAEs) and MAARI adverse events within 42 days post-LAIV vaccination were captured in seasonal and pandemic LAIV vaccinated study subjects in the intervention area.
726461|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
726462|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
726463|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
726464|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
726465|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
726466|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
726467|NCT00138294|E1|Reported Event|All Enrolled Study Participants|Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers
726468|NCT00138203|B1|Baseline|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
726469|NCT00138203|P1|Participant Flow|SAHA|Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
726470|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
726471|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
726472|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
726473|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
726474|NCT00138203|E1|Reported Event|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
726672|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
727072|NCT00134784|B4|Baseline|Levodopa 600 mg/Day|Subjects on Levodopa 600 mg/day
726475|NCT00138151|B1|Baseline|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
726476|NCT00138151|P1|Participant Flow|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
726477|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
726478|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
726479|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
726480|NCT00138151|E1|Reported Event|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
726481|NCT00138125|B1|Baseline|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
726482|NCT00138125|P1|Participant Flow|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
726483|NCT00138125|O1|Outcome|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
726484|NCT00138125|E1|Reported Event|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
726485|NCT00138073|B1|Baseline|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
726486|NCT00138073|P1|Participant Flow|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
726487|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
726488|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
726489|NCT00138073|E1|Reported Event|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
726490|NCT00138034|B3|Baseline|Total|Total of all reporting groups
726491|NCT00138034|B2|Baseline|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
726492|NCT00138034|B1|Baseline|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
726493|NCT00138034|P2|Participant Flow|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
726494|NCT00138034|P1|Participant Flow|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
726495|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
726496|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
726497|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
726498|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
726499|NCT00138034|E2|Reported Event|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
726500|NCT00138034|E1|Reported Event|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
726501|NCT00137969|B3|Baseline|Total|Total of all reporting groups
726502|NCT00137969|B2|Baseline|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726503|NCT00137969|B1|Baseline|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726504|NCT00137969|P2|Participant Flow|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726572|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726505|NCT00137969|P1|Participant Flow|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726506|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726507|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726508|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726509|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726510|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726511|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726512|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726513|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726514|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726515|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726516|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726517|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726518|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726519|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726520|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726521|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726673|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726522|NCT00137969|E2|Reported Event|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726523|NCT00137969|E1|Reported Event|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
726524|NCT00137631|B3|Baseline|Total|Total of all reporting groups
726525|NCT00137631|B2|Baseline|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726526|NCT00137631|B1|Baseline|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726527|NCT00137631|P2|Participant Flow|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726528|NCT00137631|P1|Participant Flow|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726529|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726530|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726531|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726532|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726533|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726534|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726535|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726536|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726537|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726538|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726539|NCT00137631|E2|Reported Event|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
726540|NCT00137631|E1|Reported Event|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
726541|NCT00137449|B3|Baseline|Total|Total of all reporting groups
726542|NCT00137449|B2|Baseline|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726543|NCT00137449|B1|Baseline|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726544|NCT00137449|P2|Participant Flow|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726545|NCT00137449|P1|Participant Flow|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726546|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726547|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726548|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726549|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726550|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726551|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726619|NCT00137423|E2|Reported Event|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726552|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726553|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726554|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726555|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726556|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726557|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726558|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726559|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726560|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726561|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726562|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726563|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726564|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726565|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726566|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726567|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726568|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726569|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726570|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726571|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726674|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726573|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726574|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726575|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726576|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726577|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726578|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726579|NCT00137449|E2|Reported Event|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726580|NCT00137449|E1|Reported Event|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
726581|NCT00137436|B1|Baseline|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726582|NCT00137436|P1|Participant Flow|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m^2) + Prednisone 5 mg given twice daily
726583|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726584|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726585|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726586|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726587|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726588|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726589|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726590|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726591|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726592|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726593|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726594|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726595|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726596|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726597|NCT00137436|E1|Reported Event|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
726598|NCT00137423|B3|Baseline|Total|Total of all reporting groups
726599|NCT00137423|B2|Baseline|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726620|NCT00137423|E1|Reported Event|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726621|NCT00137280|B3|Baseline|Total|Total of all reporting groups
726622|NCT00137280|B2|Baseline|Usual Care|Continue with usual care
727073|NCT00134784|B3|Baseline|Levodopa 300 mg/Day|Subjects on 300 mg/day of Levodopa
726600|NCT00137423|B1|Baseline|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726601|NCT00137423|P2|Participant Flow|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726602|NCT00137423|P1|Participant Flow|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726603|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726604|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726605|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726606|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726607|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
726608|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726609|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726610|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726611|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726612|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726613|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726614|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726615|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726616|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726617|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726618|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
726623|NCT00137280|B1|Baseline|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
726624|NCT00137280|P2|Participant Flow|Usual Care|Continue with usual care
726625|NCT00137280|P1|Participant Flow|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
726626|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
726627|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
726628|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
726629|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
726630|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
726631|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
726632|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
726633|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
726634|NCT00137280|E2|Reported Event|Usual Care|Continue with usual care
726635|NCT00137280|E1|Reported Event|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
726636|NCT00137267|B3|Baseline|Total|Total of all reporting groups
726637|NCT00137267|B2|Baseline|Arm 2 - Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
726638|NCT00137267|B1|Baseline|Arm 1 - Time Limited Case Management (TLC)|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
726639|NCT00137267|P2|Participant Flow|Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group."
726640|NCT00137267|P1|Participant Flow|Time Limited Case Management|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
726641|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
726642|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
726643|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
726644|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
726645|NCT00137267|E2|Reported Event|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
726646|NCT00137267|E1|Reported Event|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
726647|NCT00137111|B5|Baseline|Total|Total of all reporting groups
726648|NCT00137111|B4|Baseline|Non Randomized|Patients not randomized for window study
726649|NCT00137111|B3|Baseline|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
726650|NCT00137111|B2|Baseline|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
726651|NCT00137111|B1|Baseline|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
726652|NCT00137111|P4|Participant Flow|Non Randomized|Patients not randomized for window study
726653|NCT00137111|P3|Participant Flow|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
726654|NCT00137111|P2|Participant Flow|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
726655|NCT00137111|P1|Participant Flow|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
726656|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
726657|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
726658|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
726659|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
726660|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
726661|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
726662|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
726663|NCT00137111|O1|Outcome|Patients With High Risk of CNS Relapse|This is a subset of all patients enrolled. It is not a specific treatment arm.
726664|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
726665|NCT00137111|E1|Reported Event|Total Therapy|Total therapy applies to all eligible patients.
726666|NCT00137046|B3|Baseline|Total|Total of all reporting groups
726667|NCT00137046|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726668|NCT00137046|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726669|NCT00137046|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726670|NCT00137046|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726671|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726675|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726676|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726677|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726678|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726679|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726680|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726681|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726682|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726683|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726684|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726685|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726686|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726687|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726688|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726689|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726690|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726691|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726692|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726693|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726694|NCT00137046|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726695|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726696|NCT00137046|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726697|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726698|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726699|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726700|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726701|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726702|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726703|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726704|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726705|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726706|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726707|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726708|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726709|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726710|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726711|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726712|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726713|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726714|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726715|NCT00137046|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
726716|NCT00137046|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
726717|NCT00136955|B1|Baseline|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
726718|NCT00136955|P1|Participant Flow|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
726891|NCT00135798|E1|Reported Event|Standard Clinical Care: Genotypes 1, 4, 6|Subjects who received no LADR treatment (Per Protocol analysis)
726719|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
726720|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
726721|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
726722|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
726723|NCT00136955|E1|Reported Event|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
726724|NCT00136916|B3|Baseline|Total|Total of all reporting groups
726725|NCT00136916|B2|Baseline|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726726|NCT00136916|B1|Baseline|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726727|NCT00136916|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726728|NCT00136916|P1|Participant Flow|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726729|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726730|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726731|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726732|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726733|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726734|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726735|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726736|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726737|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726738|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726739|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726740|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726741|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726742|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726743|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726744|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726892|NCT00135694|B4|Baseline|Total|Total of all reporting groups
742654|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
726745|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726746|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726747|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726748|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726749|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726750|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726751|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726752|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726753|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726754|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726755|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726756|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726757|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726758|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726759|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726760|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726761|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726762|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726763|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726764|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726765|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726766|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726767|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726768|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726986|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726769|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726770|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726771|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726772|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726773|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726774|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726775|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726776|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726777|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726778|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726779|NCT00136916|E2|Reported Event|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
726780|NCT00136916|E1|Reported Event|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
726781|NCT00136838|B1|Baseline|Study Participants|This is a within-group study design, all participant who completed the study completed 2 phases of treatment, done in random order, each lasting 5 days and separated by at least 2 weeks. During one of the phases participants were exposed to active cigarette cues (pack of cigarettes, smoke) and during the other phase they were exposed to sham control cues (water bottle and the glass)
726782|NCT00136838|P2|Participant Flow|Active Cue First, Then Neutral Cue|"Each participant receives two consecutive interventions in random order.~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue"
726783|NCT00136838|P1|Participant Flow|Neutral Cue First, Then Active Cue|"Participants receives two consecutive interventions in random order.~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue"
726784|NCT00136838|O2|Outcome|Neutral Cue Craving|intensity of craving following cue exposure
726785|NCT00136838|O1|Outcome|Active Cue Craving|intensity of craving following cue exposure
726786|NCT00136838|O2|Outcome|Neutral Cue|During this phase of study participants were exposed to a neutral (sham) cue: a bottle of water and a glass
726787|NCT00136838|O1|Outcome|Active Cue|During this phase participants were exposed to active cigarette cues: pack of cigarettes and a cigarette smoke
726788|NCT00136838|E2|Reported Event|Active Cue|1.Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
726789|NCT00136838|E1|Reported Event|Neutral Cue|Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
726790|NCT00136812|B3|Baseline|Total|Total of all reporting groups
726791|NCT00136812|B2|Baseline|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
726792|NCT00136812|B1|Baseline|Control|Usual care provided NRT during hospitalization with brief cessation advice.
726793|NCT00136812|P2|Participant Flow|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
726794|NCT00136812|P1|Participant Flow|Control|Usual care provided NRT during hospitalization with brief cessation advice.
726795|NCT00136812|O2|Outcome|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
726796|NCT00136812|O1|Outcome|Control|Usual care provided NRT during hospitalization with brief cessation advice.
726843|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
742655|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
726797|NCT00136812|E2|Reported Event|2: Intervention|"intervention~Tobacco Use Cessation: This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge."
726798|NCT00136812|E1|Reported Event|1: Enhanced Standard Care Control|enhanced standard care control
726799|NCT00136760|B5|Baseline|Total|Total of all reporting groups
726800|NCT00136760|B4|Baseline|NR + PLA|Non-contingent reinforcement plus placebo
726801|NCT00136760|B3|Baseline|NR + BUP|Non-contingent reinforcement plus bupropion
726802|NCT00136760|B2|Baseline|CM + PLA|Contingent reinforcement plus placebo
726803|NCT00136760|B1|Baseline|CM + BUP|Contingent reinforcement plus bupropion
726804|NCT00136760|P4|Participant Flow|NR + PLA|Non-contingent reinforcement plus placebo
726805|NCT00136760|P3|Participant Flow|NR + BUP|Non-contingent reinforcement plus bupropion
726806|NCT00136760|P2|Participant Flow|CM + PLA|Contingent reinforcement plus placebo
726807|NCT00136760|P1|Participant Flow|CM + BUP|Contingent reinforcement plus bupropion
726808|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
726809|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
726810|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
726811|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
726812|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
726813|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
726814|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
726815|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
726816|NCT00136760|E4|Reported Event|NR + PLA|Non-contingent reinforcement plus placebo
726817|NCT00136760|E3|Reported Event|NR + BUP|Non-contingent reinforcement plus bupropion
726818|NCT00136760|E2|Reported Event|CM + PLA|Contingent reinforcement plus placebo
726819|NCT00136760|E1|Reported Event|CM + BUP|Contingent reinforcement plus bupropion
726820|NCT00136695|B3|Baseline|Total|Total of all reporting groups
726821|NCT00136695|B2|Baseline|Placebo|"placebo~anastrozole: 1 mg QD"
726822|NCT00136695|B1|Baseline|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
726823|NCT00136695|P2|Participant Flow|Placebo|"placebo~anastrozole: 1 mg QD"
726824|NCT00136695|P1|Participant Flow|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
726825|NCT00136695|O2|Outcome|Placebo|"placebo~anastrozole: 1 mg QD"
726826|NCT00136695|O1|Outcome|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
726827|NCT00136695|E2|Reported Event|Placebo|"placebo~anastrozole: 1 mg QD"
726828|NCT00136695|E1|Reported Event|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
726829|NCT00136357|B3|Baseline|Total|Total of all reporting groups
726830|NCT00136357|B2|Baseline|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
726831|NCT00136357|B1|Baseline|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
726832|NCT00136357|P2|Participant Flow|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
726833|NCT00136357|P1|Participant Flow|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
726834|NCT00136357|O2|Outcome|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
726835|NCT00136357|O1|Outcome|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
726836|NCT00136357|E2|Reported Event|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
726837|NCT00136357|E1|Reported Event|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
726838|NCT00136318|B3|Baseline|Total|Total of all reporting groups
726839|NCT00136318|B2|Baseline|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
726840|NCT00136318|B1|Baseline|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
726841|NCT00136318|P2|Participant Flow|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
726842|NCT00136318|P1|Participant Flow|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
726890|NCT00135798|E2|Reported Event|LADR Treatment (All Genotypes)|This group combines all who received LADR treatment (Per Protocol analysis) for all Genotypes 1,4,6 and 2,3
742656|NCT00094172|E2|Reported Event|Placebo|Non-Active Comparator
726844|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
726845|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
726846|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
726847|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
726848|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
726849|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
726850|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
726851|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
726852|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period, patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
726853|NCT00136318|E2|Reported Event|Placebo|
726854|NCT00136318|E1|Reported Event|Escitalopram|
726855|NCT00136084|B3|Baseline|Total|Total of all reporting groups
726856|NCT00136084|B2|Baseline|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
726857|NCT00136084|B1|Baseline|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
726858|NCT00136084|P2|Participant Flow|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
726859|NCT00136084|P1|Participant Flow|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
726860|NCT00136084|O1|Outcome|Overall|17 of the 232 eligible patients
726861|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (Ara-C) (LDAC)
726862|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (Ara-C) (HDAC)
726863|NCT00136084|O1|Outcome|Overall|Evaluation of all study participants
726864|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
726865|NCT00136084|O1|Outcome|Overall|Patients who have no response to one course of induction therapy
726866|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
726867|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
726868|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
726869|NCT00136084|E2|Reported Event|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
726870|NCT00136084|E1|Reported Event|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
726871|NCT00135798|B4|Baseline|Total|Total of all reporting groups
726872|NCT00135798|B3|Baseline|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
726873|NCT00135798|B2|Baseline|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
726874|NCT00135798|B1|Baseline|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
726875|NCT00135798|P3|Participant Flow|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
726876|NCT00135798|P2|Participant Flow|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
726877|NCT00135798|P1|Participant Flow|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
726878|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
726879|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726880|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726881|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
726882|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726883|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726884|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
726885|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726886|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726887|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
726888|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726889|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
726893|NCT00135694|B3|Baseline|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726894|NCT00135694|B2|Baseline|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726895|NCT00135694|B1|Baseline|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
726896|NCT00135694|P3|Participant Flow|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726897|NCT00135694|P2|Participant Flow|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726898|NCT00135694|P1|Participant Flow|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
726899|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726900|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726901|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726902|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726903|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726904|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726905|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726906|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726907|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726908|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726909|NCT00135694|O1|Outcome|All Enrolled|Subjects who underwent liver transplantation in the trial.
726910|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726911|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726912|NCT00135694|E3|Reported Event|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
726913|NCT00135694|E2|Reported Event|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
726914|NCT00135694|E1|Reported Event|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
726915|NCT00135356|B3|Baseline|Total|Total of all reporting groups
726916|NCT00135356|B2|Baseline|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726917|NCT00135356|B1|Baseline|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726918|NCT00135356|P2|Participant Flow|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726919|NCT00135356|P1|Participant Flow|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726920|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726921|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726922|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726989|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726923|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726924|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726925|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726926|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726927|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726928|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726929|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726930|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726931|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726932|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726933|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726934|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726935|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726936|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726937|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726938|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726939|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726940|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726941|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726942|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726943|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726944|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726945|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726946|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726987|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726988|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726947|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726948|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726949|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726950|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726951|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726952|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726953|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726954|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
726955|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
726956|NCT00135356|E2|Reported Event|PI/RTV Control Arm|
726957|NCT00135356|E1|Reported Event|ATV/RTV Switch Arm|
726958|NCT00135330|B4|Baseline|Total|Total of all reporting groups
726959|NCT00135330|B3|Baseline|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726960|NCT00135330|B2|Baseline|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726961|NCT00135330|B1|Baseline|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726962|NCT00135330|P3|Participant Flow|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726963|NCT00135330|P2|Participant Flow|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726964|NCT00135330|P1|Participant Flow|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726965|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726966|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726967|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726968|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726969|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726970|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726971|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726972|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726973|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726974|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726975|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726976|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726977|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726978|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726979|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726980|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726981|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726982|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726983|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726984|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726985|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726990|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726991|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726992|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726993|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726994|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726995|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726996|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
726997|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
726998|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
726999|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727000|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727001|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727002|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727003|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727004|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727005|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727006|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727007|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727008|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727009|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727010|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727011|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727012|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727013|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727014|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727015|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727016|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727017|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727018|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727019|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727020|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727021|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727022|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727023|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727024|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727025|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727026|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727027|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727028|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727029|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727030|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727031|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727032|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727033|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727034|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727060|NCT00134901|B3|Baseline|Total|Total of all reporting groups
727061|NCT00134901|B2|Baseline|Placebo|Placebo daily dose
727035|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727036|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727037|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727038|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727039|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727040|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727041|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727042|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727043|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727044|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727045|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727046|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727047|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727048|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727049|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727050|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727051|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727052|NCT00135330|E3|Reported Event|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
727053|NCT00135330|E2|Reported Event|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
727054|NCT00135330|E1|Reported Event|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
727055|NCT00135200|B1|Baseline|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
727056|NCT00135200|P1|Participant Flow|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
727057|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
727058|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
727059|NCT00135200|E1|Reported Event|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
727074|NCT00134784|B2|Baseline|Levodopa 150mg/Day|Subjects on 150mg/day of Levodopa
727075|NCT00134784|B1|Baseline|Placebo Group|Subjects on placebo
727076|NCT00134784|P4|Participant Flow|Levodopa 600 mg/Day|Levodopa 600/day, [123I]ß-CIT and SPECT imaging
727077|NCT00134784|P3|Participant Flow|Levodopa 300 mg/Day|Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging
727078|NCT00134784|P2|Participant Flow|Levodopa 150mg/Day|Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging
727079|NCT00134784|P1|Participant Flow|Placebo|Placebo group
727080|NCT00134784|O4|Outcome|Levodopa 3|Subjects on 600 mg/day of Levodopa
727081|NCT00134784|O3|Outcome|Levodopa 2|Subjects on 300 mg/day of Levodopa
727082|NCT00134784|O2|Outcome|Levodopa|Subjects on 150 mg/day of Levodopa
727083|NCT00134784|O1|Outcome|Placebo Group|Participants receiving placebo
727084|NCT00134784|E1|Reported Event|I123BCIT|[123I]ß CIT and SPECT imaging' .
727085|NCT00134719|B4|Baseline|Total|Total of all reporting groups
727086|NCT00134719|B3|Baseline|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727087|NCT00134719|B2|Baseline|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727088|NCT00134719|B1|Baseline|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727089|NCT00134719|P3|Participant Flow|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727090|NCT00134719|P2|Participant Flow|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727091|NCT00134719|P1|Participant Flow|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727092|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727093|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727094|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727095|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727096|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727097|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727098|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727099|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727100|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727101|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727102|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727103|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727104|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727105|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727106|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727107|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727108|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727225|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727109|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727110|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727111|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727112|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727113|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727114|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727115|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727116|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727117|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727118|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727119|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727120|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727121|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727122|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727123|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727124|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727125|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727126|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727127|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727128|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727129|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727130|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727131|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727132|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727133|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727134|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727135|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727136|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727137|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727138|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727139|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727140|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727141|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727142|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727143|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727144|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727145|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727146|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727147|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727148|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727149|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727150|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727151|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727152|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727153|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727154|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727155|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727156|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727157|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727158|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727159|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727160|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727161|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727162|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727163|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727164|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727165|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727166|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727167|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727168|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727169|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727170|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727171|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727172|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727173|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727174|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727175|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727176|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727177|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727178|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727179|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727180|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727181|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727182|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727183|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727184|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727185|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727186|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727187|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727188|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727189|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727190|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727191|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727192|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727193|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727194|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727195|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727196|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727197|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727198|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727199|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727200|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727201|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727202|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727203|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727204|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727205|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727206|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727207|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727208|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727209|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727210|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727211|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727212|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727213|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727214|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727215|NCT00134719|E3|Reported Event|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
727216|NCT00134719|E2|Reported Event|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727217|NCT00134719|E1|Reported Event|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
727218|NCT00134563|B4|Baseline|Total|Total of all reporting groups
727219|NCT00134563|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727220|NCT00134563|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727221|NCT00134563|B1|Baseline|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727222|NCT00134563|P3|Participant Flow|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727223|NCT00134563|P2|Participant Flow|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727224|NCT00134563|P1|Participant Flow|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727226|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727227|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727228|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727229|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727230|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727231|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727232|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727233|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727234|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727235|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727236|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727237|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727238|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727239|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727240|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727241|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727242|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727243|NCT00134563|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
727244|NCT00134563|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
727245|NCT00134563|E1|Reported Event|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
727246|NCT00134381|B1|Baseline|Bilateral Comparison|In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body.
727247|NCT00134381|P6|Participant Flow|Caffeine in Cream Vehicle (R Side: Active; L Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body.
727248|NCT00134381|P5|Participant Flow|Caffeine in Cream Vehicle (L Side: Active; R Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body.
727249|NCT00134381|P4|Participant Flow|Caffeine in Acetone Vehicle (R Side: Active; L Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the right side of the body and placebo to a test site on the left side of the body.
727250|NCT00134381|P3|Participant Flow|Caffeine in Acetone Vehicle (L Side: Active; R Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of caffeine to a test site on the left side of the body and placebo to a test site on the right side of the body.
727251|NCT00134381|P2|Participant Flow|EGCG in Acetone Vehicle (R Side: Active; L Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the right side of the body and placebo to a test site on the left side of the body.
727252|NCT00134381|P1|Participant Flow|EGCG in Acetone Vehicle (L Side: Active; R Side: Placebo)|bilateral comparison Subjects randomized to this group received applications of EGCG to a test site on the left side of the body and placebo to a test site on the right side of the body.
727253|NCT00134381|O6|Outcome|Placebo Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727254|NCT00134381|O5|Outcome|Caffeine in Vehicle Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727255|NCT00134381|O4|Outcome|Placebo Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727256|NCT00134381|O3|Outcome|Caffeine in Vehicle Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727257|NCT00134381|O2|Outcome|Placebo Cream (0.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at 0.5 times the subjects' individual minimal erythema dose (MED).
727258|NCT00134381|O1|Outcome|Caffeine in Vehicle Cream (0.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at 0.5 times the subjects' individual minimal erythema dose (MED).
727259|NCT00134381|O4|Outcome|Placebo (Acetone Vehicle in Subjects Who Received Caffeine)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727260|NCT00134381|O3|Outcome|Caffeine in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727261|NCT00134381|O2|Outcome|Placebo (Acetone Vehicle in Subjects Who Received EGCG)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727262|NCT00134381|O1|Outcome|EGCG in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727369|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727370|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727263|NCT00134381|O4|Outcome|Placebo Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727264|NCT00134381|O3|Outcome|Caffeine in Vehicle Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727265|NCT00134381|O2|Outcome|Placebo Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727266|NCT00134381|O1|Outcome|Caffeine in Vehicle Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727267|NCT00134381|O4|Outcome|Placebo Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727268|NCT00134381|O3|Outcome|Caffeine in Vehicle Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727269|NCT00134381|O2|Outcome|Placebo Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727270|NCT00134381|O1|Outcome|Caffeine in Vehicle Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727271|NCT00134381|O4|Outcome|Placebo Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727272|NCT00134381|O3|Outcome|Caffeine in Vehicle Cream (1.5 MED Group)|bilateral comparison Subjects were randomized to receive applications of 4-6% caffeine (active drug) on the test site on one side of the body after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).
727273|NCT00134381|O2|Outcome|Placebo Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of cream vehicle (placebo) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727274|NCT00134381|O1|Outcome|Caffeine in Vehicle Cream (1.0 MED Group)|bilateral comparison Subjects were randomized to receive applications of 6% caffeine (active drug) on the test site on one side of the body after exposure to UVB at the subjects' individual minimal erythema dose (MED).
727275|NCT00134381|O4|Outcome|Placebo (Acetone Vehicle in Subjects Who Received Caffeine)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727276|NCT00134381|O3|Outcome|Caffeine in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727277|NCT00134381|O2|Outcome|Placebo (Acetone Vehicle in Subjects Who Received EGCG)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727278|NCT00134381|O1|Outcome|EGCG in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727279|NCT00134381|O4|Outcome|Placebo (Acetone Vehicle in Subjects Who Received Caffeine)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727280|NCT00134381|O3|Outcome|Caffeine in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of caffeine (12 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727281|NCT00134381|O2|Outcome|Placebo (Acetone Vehicle in Subjects Who Received EGCG)|bilateral comparison Subjects were randomized to receive applications of acetone vehicle (placebo) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727282|NCT00134381|O1|Outcome|EGCG in Acetone Vehicle|bilateral comparison Subjects were randomized to receive applications of EGCG (28.3 mg/mL; active drug) on the test site on one side of the body after exposure to UVB that was twice their individual minimal erythema dose (MED).
727283|NCT00134381|E1|Reported Event|Bilateral Comparison|In this bilateral comparison study, subjects were randomized to receive applications of green tea product or placebo to test sites on the left and right sides of the body after exposure of the test sites to UVB.
727284|NCT00134056|B3|Baseline|Total|Total of all reporting groups
727285|NCT00134056|B2|Baseline|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727286|NCT00134056|B1|Baseline|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727371|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727287|NCT00134056|P2|Participant Flow|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727288|NCT00134056|P1|Participant Flow|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727289|NCT00134056|O2|Outcome|Arm II: Atrasentan Hydrochloride|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727290|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727291|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727292|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727293|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727294|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727295|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727296|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727297|NCT00134056|O2|Outcome|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
727298|NCT00134056|O1|Outcome|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
727299|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727300|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727301|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727319|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
727302|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727303|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
727304|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
727305|NCT00134056|E2|Reported Event|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
727306|NCT00134056|E1|Reported Event|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
727307|NCT00134043|B3|Baseline|Total|Total of all reporting groups
727308|NCT00134043|B2|Baseline|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
727309|NCT00134043|B1|Baseline|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
727310|NCT00134043|P2|Participant Flow|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
727311|NCT00134043|P1|Participant Flow|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
727312|NCT00134043|O2|Outcome|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
727313|NCT00134043|O1|Outcome|DTCs (Well-differentiated Thyroid Carcinomas)|Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
727314|NCT00134043|E1|Reported Event|Arm I & Arm II|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
727315|NCT00134004|B1|Baseline|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
727316|NCT00134004|P1|Participant Flow|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
727317|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
727318|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
742657|NCT00094172|E1|Reported Event|Atorvastatin|Drug: Atorvastatin
727320|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
727321|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
727322|NCT00134004|E1|Reported Event|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
727323|NCT00133978|B5|Baseline|Total|Total of all reporting groups
727324|NCT00133978|B4|Baseline|Placebo|Non-isonitrogenic, iso-caloric placebo solution
727325|NCT00133978|B3|Baseline|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
727326|NCT00133978|B2|Baseline|Antioxidants|Antioxidant supplementation
727327|NCT00133978|B1|Baseline|Glutamine|Glutamine supplementation
727328|NCT00133978|P4|Participant Flow|Placebo|Non-isonitrogenic, iso-caloric placebo solution
727329|NCT00133978|P3|Participant Flow|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously , and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
727330|NCT00133978|P2|Participant Flow|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously, and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
727331|NCT00133978|P1|Participant Flow|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
727332|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
727333|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
727334|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
727335|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
727336|NCT00133978|O4|Outcome|No Antioxidants|Non-isonitrogenic, iso-caloric placebo solution
727337|NCT00133978|O3|Outcome|Antioxidants|500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
727338|NCT00133978|O2|Outcome|No Glutamine|Non-isonitrogenic, iso-caloric placebo solution
727339|NCT00133978|O1|Outcome|Glutamine|0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
727340|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
727341|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
727342|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
727343|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
727344|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
727345|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
727346|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
727347|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
727348|NCT00133978|E4|Reported Event|Placebo|Non-isonitrogenic, iso-caloric placebo solution
727349|NCT00133978|E3|Reported Event|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
727350|NCT00133978|E2|Reported Event|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
727351|NCT00133978|E1|Reported Event|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
727352|NCT00133952|B3|Baseline|Total|Total of all reporting groups
727353|NCT00133952|B2|Baseline|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727354|NCT00133952|B1|Baseline|Placebo|Taken orally daily for up to 48 months
727355|NCT00133952|P2|Participant Flow|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727356|NCT00133952|P1|Participant Flow|Placebo|Taken orally daily for up to 48 months
727357|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727358|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727359|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727360|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727361|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727362|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727363|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727364|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727365|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727366|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727367|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727368|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727372|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727373|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727374|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
727375|NCT00133952|E2|Reported Event|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
727376|NCT00133952|E1|Reported Event|Placebo|Taken orally daily for up to 48 months
727377|NCT00133809|B1|Baseline|Islet Transplant|"10 subjects were found eligible and were can be matched to an appropriate donor will receive/have received an islet transplant---1 INELIGIBLE WHILE ON WAITLIST.~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
727378|NCT00133809|P1|Participant Flow|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
727379|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
727380|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
727381|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
727382|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
727383|NCT00133809|E1|Reported Event|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
727384|NCT00133705|B3|Baseline|Total|Total of all reporting groups
727385|NCT00133705|B2|Baseline|Placebo|Twenty women received a placebo pill daily.
727386|NCT00133705|B1|Baseline|Mifepristone 5 mg.|Twenty-two women received 5 mg. mifepristone daily.
727387|NCT00133705|P2|Participant Flow|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
727388|NCT00133705|P1|Participant Flow|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
727389|NCT00133705|O2|Outcome|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
727390|NCT00133705|O1|Outcome|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
727391|NCT00133705|E2|Reported Event|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
727392|NCT00133705|E1|Reported Event|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
727393|NCT00133575|B8|Baseline|Total|Total of all reporting groups
727394|NCT00133575|B7|Baseline|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727395|NCT00133575|B6|Baseline|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727396|NCT00133575|B5|Baseline|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727397|NCT00133575|B4|Baseline|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727398|NCT00133575|B3|Baseline|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727399|NCT00133575|B2|Baseline|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727400|NCT00133575|B1|Baseline|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727401|NCT00133575|P7|Participant Flow|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727402|NCT00133575|P6|Participant Flow|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727403|NCT00133575|P5|Participant Flow|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727404|NCT00133575|P4|Participant Flow|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727405|NCT00133575|P3|Participant Flow|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727406|NCT00133575|P2|Participant Flow|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727407|NCT00133575|P1|Participant Flow|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727408|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727409|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727536|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727410|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727411|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727412|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727413|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727414|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727415|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727416|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727417|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727418|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727419|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727420|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727421|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727422|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727423|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727424|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727425|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727426|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727427|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727428|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727429|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727430|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727431|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727432|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727433|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727434|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727435|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727436|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727437|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727438|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727439|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727440|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727441|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727442|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727443|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727444|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727445|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727446|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727447|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727448|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
743028|NCT00092495|O1|Outcome|Girls 10-15 Years|
727449|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727450|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727451|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727452|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727453|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727454|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727455|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727456|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727457|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727458|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727459|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727460|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727461|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727462|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727463|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727464|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727465|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727466|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727467|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727468|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727469|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727470|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727471|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727472|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727473|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727474|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727475|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727476|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727477|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727478|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727479|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727480|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727481|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727482|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727483|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727484|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727485|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727486|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727487|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727537|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
727488|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727489|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727490|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727491|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727492|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727493|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727494|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727495|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727496|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727497|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727498|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727499|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727500|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727501|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727502|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727503|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727504|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727505|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727506|NCT00133575|E7|Reported Event|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
727507|NCT00133575|E6|Reported Event|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727508|NCT00133575|E5|Reported Event|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727509|NCT00133575|E4|Reported Event|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727510|NCT00133575|E3|Reported Event|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
727511|NCT00133575|E2|Reported Event|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
727512|NCT00133575|E1|Reported Event|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
727513|NCT00132873|B1|Baseline|Xyrem (Sodium Oxybate)|
727514|NCT00132873|P1|Participant Flow|Xyrem (Sodium Oxybate)|
727515|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
727516|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
727517|NCT00132873|E1|Reported Event|Xyrem (Sodium Oxybate)|
727518|NCT00132808|B4|Baseline|Total|Total of all reporting groups
727519|NCT00132808|B3|Baseline|Placebo|Placebo given at randomization and Month 12
727520|NCT00132808|B2|Baseline|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727521|NCT00132808|B1|Baseline|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727522|NCT00132808|P3|Participant Flow|Placebo|Placebo given at randomization and Month 12
727523|NCT00132808|P2|Participant Flow|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727524|NCT00132808|P1|Participant Flow|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727525|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
727526|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727527|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727528|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
727529|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727530|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727531|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
727532|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727533|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727534|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
727535|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727538|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727539|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727540|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
727541|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727542|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727543|NCT00132808|E3|Reported Event|Placebo|Placebo given at randomization and Month 12
727544|NCT00132808|E2|Reported Event|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
727545|NCT00132808|E1|Reported Event|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
727546|NCT00132769|B3|Baseline|Total|Total of all reporting groups
727547|NCT00132769|B2|Baseline|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727548|NCT00132769|B1|Baseline|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727549|NCT00132769|P2|Participant Flow|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727550|NCT00132769|P1|Participant Flow|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727551|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727552|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727553|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727554|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727555|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727556|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727557|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727558|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727559|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727560|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727561|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727562|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727563|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727564|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727565|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727566|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727567|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727568|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727569|NCT00132769|E2|Reported Event|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
727570|NCT00132769|E1|Reported Event|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
727571|NCT00132730|B5|Baseline|Total|Total of all reporting groups
727572|NCT00132730|B4|Baseline|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727573|NCT00132730|B3|Baseline|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727574|NCT00132730|B2|Baseline|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727575|NCT00132730|B1|Baseline|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727576|NCT00132730|P6|Participant Flow|Usual Care|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
727577|NCT00132730|P5|Participant Flow|MK-0873 2.5 mg + Usual Care|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
727578|NCT00132730|P4|Participant Flow|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727579|NCT00132730|P3|Participant Flow|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727580|NCT00132730|P2|Participant Flow|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
727581|NCT00132730|P1|Participant Flow|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
727582|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727583|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727584|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727585|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727586|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727587|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727588|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727589|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727590|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727591|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727592|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727593|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727594|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727595|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727596|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727597|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727598|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727599|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727600|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727601|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727602|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727603|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727604|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727605|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727606|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727607|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727608|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727609|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727610|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727611|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727612|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727613|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727614|NCT00132730|E8|Reported Event|Usual Care EXT2|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
727615|NCT00132730|E7|Reported Event|MK-0873 2.5 mg + Usual Care EXT 2|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
727616|NCT00132730|E6|Reported Event|Placebo EXT 1|Participants receive placebo tablets once daily for 12 weeks in Period III (EXT1)
727617|NCT00132730|E5|Reported Event|MK-0873 2.5 mg EXT 1|Participants receive MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727618|NCT00132730|E4|Reported Event|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
727619|NCT00132730|E3|Reported Event|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
727620|NCT00132730|E2|Reported Event|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
727621|NCT00132730|E1|Reported Event|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
727622|NCT00132691|B3|Baseline|Total|Total of all reporting groups
727623|NCT00132691|B2|Baseline|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
727624|NCT00132691|B1|Baseline|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
727625|NCT00132691|P2|Participant Flow|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
727626|NCT00132691|P1|Participant Flow|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
727627|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727628|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727629|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727630|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727631|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727632|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727633|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727634|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727635|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727636|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727637|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727638|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727639|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
727640|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
727641|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
727642|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
727643|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727644|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727645|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
727646|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy
727647|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
727648|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
727649|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
727650|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
727651|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727652|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727653|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727654|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727655|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
727656|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
727657|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
727658|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727659|NCT00132691|O2|Outcome|Systemic Therapy|Oral corticosteroids supplemented with immunosuppressive drugs if indicated were given according to published guidelines developed by an expert panel. For participants with active uveitis at baseline, 1 mg/kg/day up to 60 mg/day of prednisone was given until uveitis was controlled or 4 weeks had elapsed. When control was achieved, prednisone was tapered per study guidelines. Immunosuppressive drugs were added when uveitis was not initially controlled with prednisone alone, as corticosteroid-sparing agents when prednisone could not be tapered to 10 mg/day without reactivation of uveitis and for specific uveitis syndromes. Choice of immunosuppressant was made by the study ophthalmologist; immunosuppressant administration and monitoring for toxicity was conducted according to expert guidelines.
727660|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|A fluocinolone acetonide intravitreal implant (0.59 mg) was surgically placed by a study-certified surgeon was placed in each eligible eye. The first eye was implanted within 28 days of randomization and, if eligible, the second eye within the next 28 days. Prior to implant surgery, topical, periocular or systemic corticosteroids where used as needed to quiet the anterior chamber. Post-implant, systemic corticosteroids and immunosuppressive drugs were tapered and discontinued. If the second eye was not eligible for an implant initially but later became eligible, an implant was placed in the second eye at that time. The treatment algorithm included re-implantation upon reactivation and treatment per best medical judgment for failure to achieve inflammation control, treatment-limiting toxicity and systemic disease requiring systemic therapy.
727661|NCT00132691|E2|Reported Event|Systemic Therapy|Participants randomized to receive systemic therapy.
727662|NCT00132691|E1|Reported Event|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
727663|NCT00132678|B3|Baseline|Total|Total of all reporting groups
727664|NCT00132678|B2|Baseline|Placebo|IM injection every 2 weeks
727665|NCT00132678|B1|Baseline|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
727666|NCT00132678|P3|Participant Flow|Open-Label Oral Risperidone|(flexible dosage) 1 to 6 mg/day for the first 3 weeks
727667|NCT00132678|P2|Participant Flow|Placebo|intramuscular (IM) injection every 2 weeks
727668|NCT00132678|P1|Participant Flow|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks
727669|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
727670|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
727671|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
727672|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
727673|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
727674|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
727675|NCT00132678|E4|Reported Event|Open Label RISPERDAL CONSTA|Open-label Period III. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
727676|NCT00132678|E3|Reported Event|Open-Label Oral Risperidone|Open-label Period II. Flexible dosage. 1 to 6 mg/day for the first 3 weeks
727677|NCT00132678|E2|Reported Event|Placebo|Double-blind Period IV. Intramuscular (IM) injection every 2 weeks
727678|NCT00132678|E1|Reported Event|RISPERDAL CONSTA|Double-blind Period IV. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
727679|NCT00132496|B3|Baseline|Total|Total of all reporting groups
727680|NCT00132496|B2|Baseline|Rabeprazole 20 mg|once daily for 8 weeks
727681|NCT00132496|B1|Baseline|Rabeprazole 10 mg|once daily for 8 weeks
727682|NCT00132496|P2|Participant Flow|Rabeprazole 20 mg|once daily for 8 weeks
727683|NCT00132496|P1|Participant Flow|Rabeprazole 10 mg|once daily for 8 weeks
727684|NCT00132496|O2|Outcome|Rabeprazole 20 mg|once daily for 8 weeks
727685|NCT00132496|O1|Outcome|Rabeprazole 10 mg|once daily for 8 weeks
727686|NCT00132496|E2|Reported Event|Rabeprazole 20 mg|once daily for 8 weeks
727687|NCT00132496|E1|Reported Event|Rabeprazole 10 mg|once daily for 8 weeks
727688|NCT00132314|B3|Baseline|Total|Total of all reporting groups
727689|NCT00132314|B2|Baseline|Oral Antipsychotic|oral antipsychotic medication
727690|NCT00132314|B1|Baseline|Injectable Risperidone|long-acting injectable risperidone
727691|NCT00132314|P2|Participant Flow|Oral Antipsychotic|oral antipsychotic medication
727692|NCT00132314|P1|Participant Flow|Injectable Risperidone|long-acting injectable risperidone
727693|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
727694|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
727695|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
727696|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
727697|NCT00132314|E2|Reported Event|Oral Antipsychotic|oral antipsychotic medication
727698|NCT00132314|E1|Reported Event|Injectable Risperidone|long-acting injectable risperidone
727699|NCT00132132|B3|Baseline|Total|Total of all reporting groups
727700|NCT00132132|B2|Baseline|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
727701|NCT00132132|B1|Baseline|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
727702|NCT00132132|P2|Participant Flow|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
727737|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
728361|NCT00129285|O3|Outcome|3. Placebo|"Placebo~Placebo: placebo 400 mg/day"
727703|NCT00132132|P1|Participant Flow|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
727704|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
727705|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
727706|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
727707|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
727708|NCT00132132|E2|Reported Event|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
727709|NCT00132132|E1|Reported Event|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
727710|NCT00132028|B1|Baseline|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
727711|NCT00132028|P1|Participant Flow|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
727712|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
727713|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
727714|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
727715|NCT00132028|E1|Reported Event|SAHA (Vorinostat)|
727716|NCT00132002|B1|Baseline|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
727717|NCT00132002|P1|Participant Flow|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
727718|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
727719|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
727720|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
727721|NCT00132002|E1|Reported Event|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
727722|NCT00131937|B1|Baseline|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
727723|NCT00131937|P1|Participant Flow|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
727724|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
727725|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
727726|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
727727|NCT00131937|E1|Reported Event|Treatment (Sorafenib)|All patients who received Sorafenib treatment.
727728|NCT00131911|B3|Baseline|Total|Total of all reporting groups
727729|NCT00131911|B2|Baseline|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727730|NCT00131911|B1|Baseline|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727731|NCT00131911|P2|Participant Flow|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727732|NCT00131911|P1|Participant Flow|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727733|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727734|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727735|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727736|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727738|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727739|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727740|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727741|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727742|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727743|NCT00131911|E1|Reported Event|All Patients|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
727744|NCT00131885|B5|Baseline|Total|Total of all reporting groups
727745|NCT00131885|B4|Baseline|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727746|NCT00131885|B3|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727747|NCT00131885|B2|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727748|NCT00131885|B1|Baseline|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727749|NCT00131885|P4|Participant Flow|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727750|NCT00131885|P3|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727751|NCT00131885|P2|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727752|NCT00131885|P1|Participant Flow|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727753|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727754|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727755|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727756|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727757|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727758|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727759|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727760|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727761|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727762|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727763|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727799|NCT00131664|B3|Baseline|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727800|NCT00131664|B2|Baseline|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727764|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727765|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727766|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727767|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727768|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727769|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727770|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727771|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727772|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727773|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727774|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727775|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727776|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727777|NCT00131885|E4|Reported Event|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727778|NCT00131885|E3|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
727779|NCT00131885|E2|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727780|NCT00131885|E1|Reported Event|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
727781|NCT00131677|B3|Baseline|Total|Total of all reporting groups
727782|NCT00131677|B2|Baseline|Placebo|Placebo arm--received matching placebo
727783|NCT00131677|B1|Baseline|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
727784|NCT00131677|P2|Participant Flow|Placebo|Participants received matching placebo, to be taken daily.
727785|NCT00131677|P1|Participant Flow|Tenofovir Disoproxil Fumarate|Participants received TDF 300mg orally daily for 24 months (immediate arm) or 15 months (delayed arm).
727786|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
727787|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
727788|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
727789|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
727790|NCT00131677|O1|Outcome|All Enrolled Participants|
727791|NCT00131677|O1|Outcome|Treatment Emergent Cohort|Includes all who entered treatment emergent cohort (active and placebo arms)
727792|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
727793|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily.
727794|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
727795|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily
727796|NCT00131677|E2|Reported Event|Placebo|Matching placebo daily
727797|NCT00131677|E1|Reported Event|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
727798|NCT00131664|B4|Baseline|Total|Total of all reporting groups
727801|NCT00131664|B1|Baseline|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727802|NCT00131664|P6|Participant Flow|Metformin and Amaryl|Metformin Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months.
727803|NCT00131664|P5|Participant Flow|Avandamet and Amaryl|Avandamet™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months
727804|NCT00131664|P4|Participant Flow|Avandia, Amaryl and Metformin|Avandia™ + Amaryl™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Metformin was added and titrated up to 1000 mg twice daily (BID) maximum dose for an additional 6 months.
727805|NCT00131664|P3|Participant Flow|Metformin|Metformin Arm: initial dose of 500 mg twice daily (BID) was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID.
727806|NCT00131664|P2|Participant Flow|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg twice daily (BID) was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID.
727807|NCT00131664|P1|Participant Flow|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg + 1 mg once daily (OD) was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg + 2 mg OD.
727808|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727809|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727810|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727811|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727812|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727813|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727814|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727815|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727816|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727817|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727818|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727819|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727820|NCT00131664|O3|Outcome|Metformin|: 500 mg twice daily titration up to 1000 mg twice daily over 6 months
727821|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727822|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727823|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727824|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727825|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727826|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727827|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727828|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727829|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727830|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727831|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727832|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727833|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727834|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727835|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727836|NCT00131664|O2|Outcome|Avandamet|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727837|NCT00131664|O1|Outcome|Avandia and Amaryl|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727838|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727839|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727840|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727841|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727842|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727843|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727844|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727845|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727846|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727847|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727848|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727849|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727850|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727851|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727852|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727853|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727854|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727855|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727856|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727857|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727858|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727859|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
727860|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
727861|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
727862|NCT00131664|E3|Reported Event|Metformin|Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months.
727863|NCT00131664|E2|Reported Event|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg BID was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID. At month 6, patients not achieving target received additional specified drug therapy Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months
727864|NCT00131664|E1|Reported Event|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg +1 mg OD was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg / 2 mg OD. At month 6, patients not achieving target received additional specified drug therapy: Metformin was added and titrated up to 1000 mg BID maximum dose for an additional 6 months.
727865|NCT00131573|B3|Baseline|Total|Total of all reporting groups
727866|NCT00131573|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
727867|NCT00131573|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
727868|NCT00131573|P2|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
727869|NCT00131573|P1|Participant Flow|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
727870|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
727871|NCT00131573|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
727872|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
727873|NCT00131573|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
727874|NCT00131573|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
727875|NCT00131573|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
727876|NCT00131508|B3|Baseline|Total|Total of all reporting groups
727877|NCT00131508|B2|Baseline|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727878|NCT00131508|B1|Baseline|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727879|NCT00131508|P2|Participant Flow|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727880|NCT00131508|P1|Participant Flow|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727881|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727882|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727883|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727884|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727885|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727886|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727887|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727888|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727889|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727890|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727891|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727892|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727893|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727894|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727895|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727896|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727897|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727898|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727899|NCT00131508|E2|Reported Event|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
727900|NCT00131508|E1|Reported Event|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
727901|NCT00131456|B3|Baseline|Total|Total of all reporting groups
727902|NCT00131456|B2|Baseline|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
727903|NCT00131456|B1|Baseline|Placebo|Matched Placebo
727904|NCT00131456|P2|Participant Flow|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
727905|NCT00131456|P1|Participant Flow|Placebo|Matched Placebo
727906|NCT00131456|O2|Outcome|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
727907|NCT00131456|O1|Outcome|Placebo|Matched Placebo
727908|NCT00131456|E2|Reported Event|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
727909|NCT00131456|E1|Reported Event|Placebo|Matched Placebo
727910|NCT00131378|B5|Baseline|Total|Total of all reporting groups
727911|NCT00131378|B4|Baseline|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727912|NCT00131378|B3|Baseline|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727913|NCT00131378|B2|Baseline|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727914|NCT00131378|B1|Baseline|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727915|NCT00131378|P4|Participant Flow|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727916|NCT00131378|P3|Participant Flow|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727917|NCT00131378|P2|Participant Flow|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727918|NCT00131378|P1|Participant Flow|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727919|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727920|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727921|NCT00131378|O2|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727922|NCT00131378|O1|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727923|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727924|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727925|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727926|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727927|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727928|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727929|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727930|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727931|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727932|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727933|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727934|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727935|NCT00131378|E4|Reported Event|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727936|NCT00131378|E3|Reported Event|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727937|NCT00131378|E2|Reported Event|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
727938|NCT00131378|E1|Reported Event|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
727939|NCT00131352|B3|Baseline|Total|Total of all reporting groups
727940|NCT00131352|B2|Baseline|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727941|NCT00131352|B1|Baseline|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727942|NCT00131352|P2|Participant Flow|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
727943|NCT00131352|P1|Participant Flow|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
727944|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727945|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727946|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727947|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727948|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727949|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727950|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727951|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727952|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727953|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727954|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727955|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727956|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
727957|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727958|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
728224|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
727959|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
727960|NCT00131352|E4|Reported Event|Synvisc (From Saline Control) - Repeat Treatment Period|Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
727961|NCT00131352|E3|Reported Event|Synvisc - Repeat Treatment Period|Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
727962|NCT00131352|E2|Reported Event|Saline Control - Initial Treatment Period|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.
727963|NCT00131352|E1|Reported Event|Synvisc - Initial Treatment Period|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).
727964|NCT00131248|B1|Baseline|All Study Participants|
727965|NCT00131248|P2|Participant Flow|Placebo, Medications, Placebo (Group 2)|"received 3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
727966|NCT00131248|P1|Participant Flow|Medications, Placebo, Medications (Group 1)|"3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
727967|NCT00131248|O2|Outcome|Placebo|
727968|NCT00131248|O1|Outcome|Medications|
727969|NCT00131248|E2|Reported Event|Placebo|
727970|NCT00131248|E1|Reported Event|Medications|
727971|NCT00130923|B3|Baseline|Total|Total of all reporting groups
727972|NCT00130923|B2|Baseline|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
727973|NCT00130923|B1|Baseline|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
727974|NCT00130923|P2|Participant Flow|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
727975|NCT00130923|P1|Participant Flow|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
727976|NCT00130923|O2|Outcome|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
727977|NCT00130923|O1|Outcome|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
727978|NCT00130923|E2|Reported Event|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
727979|NCT00130923|E1|Reported Event|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
727980|NCT00130832|B3|Baseline|Total|Total of all reporting groups
727981|NCT00130832|B2|Baseline|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
727982|NCT00130832|B1|Baseline|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
727983|NCT00130832|P2|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
727984|NCT00130832|P1|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
727985|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
727986|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
727987|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
727988|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
727989|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
727990|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
727991|NCT00130832|E2|Reported Event|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
728410|NCT00129220|B3|Baseline|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
727992|NCT00130832|E1|Reported Event|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
727993|NCT00130793|B3|Baseline|Total|Total of all reporting groups
727994|NCT00130793|B2|Baseline|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
727995|NCT00130793|B1|Baseline|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
727996|NCT00130793|P2|Participant Flow|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
727997|NCT00130793|P1|Participant Flow|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
727998|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
727999|NCT00130793|O1|Outcome|ZOSTAVAX™With PGSU|ZOSTAVAX™with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
728000|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
728001|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
728002|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
728003|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
728004|NCT00130793|E2|Reported Event|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
728005|NCT00130793|E1|Reported Event|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
728006|NCT00130780|B3|Baseline|Total|Total of all reporting groups
728007|NCT00130780|B2|Baseline|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
728008|NCT00130780|B1|Baseline|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
728009|NCT00130780|P2|Participant Flow|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
728010|NCT00130780|P1|Participant Flow|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
728031|NCT00130689|P1|Participant Flow|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
728032|NCT00130689|O1|Outcome|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
728011|NCT00130780|O2|Outcome|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
728012|NCT00130780|O1|Outcome|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
728013|NCT00130780|E2|Reported Event|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
728014|NCT00130780|E1|Reported Event|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
728015|NCT00130728|B3|Baseline|Total|Total of all reporting groups
728016|NCT00130728|B2|Baseline|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
728017|NCT00130728|B1|Baseline|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
728018|NCT00130728|P2|Participant Flow|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
728019|NCT00130728|P1|Participant Flow|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
728020|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
728021|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
728022|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
728023|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
728024|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
728025|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
728026|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
728027|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
728028|NCT00130728|E2|Reported Event|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
728029|NCT00130728|E1|Reported Event|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
728030|NCT00130689|B1|Baseline|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
728033|NCT00130689|E1|Reported Event|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
728034|NCT00130637|B1|Baseline|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
728035|NCT00130637|P1|Participant Flow|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
728036|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
728037|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
728038|NCT00130637|E1|Reported Event|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
728039|NCT00130520|B1|Baseline|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
728040|NCT00130520|P1|Participant Flow|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
728041|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
728042|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
728043|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
728044|NCT00130520|E1|Reported Event|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
728045|NCT00130286|B5|Baseline|Total|Total of all reporting groups
728046|NCT00130286|B4|Baseline|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728047|NCT00130286|B3|Baseline|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728048|NCT00130286|B2|Baseline|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728049|NCT00130286|B1|Baseline|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728050|NCT00130286|P4|Participant Flow|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728051|NCT00130286|P3|Participant Flow|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728078|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728052|NCT00130286|P2|Participant Flow|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728053|NCT00130286|P1|Participant Flow|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728054|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728055|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728056|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728057|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728058|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728059|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728060|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728061|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728062|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728063|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728064|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728065|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728066|NCT00130286|E4|Reported Event|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728067|NCT00130286|E3|Reported Event|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728068|NCT00130286|E2|Reported Event|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728069|NCT00130286|E1|Reported Event|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
728070|NCT00130247|B3|Baseline|Total|Total of all reporting groups
728071|NCT00130247|B2|Baseline|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728072|NCT00130247|B1|Baseline|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728073|NCT00130247|P2|Participant Flow|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728074|NCT00130247|P1|Participant Flow|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728075|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728076|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728077|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728079|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728080|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728081|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728082|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728083|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728084|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728085|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728086|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728087|NCT00130247|E2|Reported Event|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
728088|NCT00130247|E1|Reported Event|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
728089|NCT00130208|B3|Baseline|Total|Total of all reporting groups
728090|NCT00130208|B2|Baseline|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
728091|NCT00130208|B1|Baseline|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
728092|NCT00130208|P2|Participant Flow|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
728093|NCT00130208|P1|Participant Flow|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
728094|NCT00130208|O2|Outcome|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
728095|NCT00130208|O1|Outcome|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
728096|NCT00130208|O2|Outcome|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
728097|NCT00130208|O1|Outcome|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
728098|NCT00130208|O2|Outcome|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
728099|NCT00130208|O1|Outcome|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
728100|NCT00130208|E2|Reported Event|Placebo|"All patients will be on standard of care ACE or ARBs.~Placebo: 0 mg gelcap"
728101|NCT00130208|E1|Reported Event|Sulodexide|"Also known as KRX-101. All patients will be on standard of care ACE or ARBs.~Sulodexide: 100 mg sulodexide gelcaps"
728102|NCT00130117|B3|Baseline|Total|Total of all reporting groups
728103|NCT00130117|B2|Baseline|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728104|NCT00130117|B1|Baseline|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728105|NCT00130117|P2|Participant Flow|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728106|NCT00130117|P1|Participant Flow|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728107|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728108|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728109|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728110|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728111|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728112|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728113|NCT00130117|O2|Outcome|Oral Contraceptive Pills (OCPs)|"PLACEBO~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728114|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728115|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728116|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728117|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728207|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728118|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728119|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728120|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728121|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728122|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728123|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728124|NCT00130117|E2|Reported Event|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
728125|NCT00130117|E1|Reported Event|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
728126|NCT00130039|B3|Baseline|Total|Total of all reporting groups
728127|NCT00130039|B2|Baseline|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728128|NCT00130039|B1|Baseline|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728129|NCT00130039|P2|Participant Flow|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728130|NCT00130039|P1|Participant Flow|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728131|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728132|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728133|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728134|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728135|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728136|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728137|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728138|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728139|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728140|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728141|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728142|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728143|NCT00130039|E2|Reported Event|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
728144|NCT00130039|E1|Reported Event|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
728145|NCT00129974|B1|Baseline|Arm 1|Pemetrexed and Gemcitabine
728146|NCT00129974|P1|Participant Flow|Arm 1|Pemetrexed and Gemcitabine
728147|NCT00129974|O1|Outcome|Arm 1|Pemetrexed and Gemcitabine
728148|NCT00129974|O1|Outcome|Arm 1|Pemetrexed and Gemcitabine
728149|NCT00129974|E1|Reported Event|Arm 1|
728150|NCT00129961|B3|Baseline|Total|Total of all reporting groups
728151|NCT00129961|B2|Baseline|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728152|NCT00129961|B1|Baseline|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728153|NCT00129961|P2|Participant Flow|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
743398|NCT00091507|B2|Baseline|Placebo|Dextrose 5%
728154|NCT00129961|P1|Participant Flow|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728155|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728156|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728157|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728158|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728159|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728160|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728208|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728209|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728210|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728211|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728161|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728162|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728163|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728164|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728165|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728166|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728167|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728212|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728213|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728214|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728215|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
743399|NCT00091507|B1|Baseline|GIK --|GIK = glucose-insulin-potassium
728168|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728169|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728170|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728171|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728172|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728173|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728174|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728216|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728217|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728218|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728219|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728175|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728176|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728177|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728178|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728179|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728180|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728181|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728220|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728221|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728222|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728223|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
743400|NCT00091507|P2|Participant Flow|Placebo|Dextrose 5%
728182|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728183|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728184|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728185|NCT00129961|E2|Reported Event|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
728186|NCT00129961|E1|Reported Event|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
728187|NCT00129766|B3|Baseline|Total|Total of all reporting groups
728188|NCT00129766|B2|Baseline|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728189|NCT00129766|B1|Baseline|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728190|NCT00129766|P2|Participant Flow|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728191|NCT00129766|P1|Participant Flow|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728192|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728193|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728194|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728195|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728196|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728197|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728198|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728199|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728200|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728201|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728202|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728203|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728204|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728205|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728206|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728225|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728226|NCT00129766|E2|Reported Event|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728227|NCT00129766|E1|Reported Event|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
728228|NCT00129727|B1|Baseline|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
728229|NCT00129727|P1|Participant Flow|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
728230|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
728231|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
728232|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
728233|NCT00129727|E1|Reported Event|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
728234|NCT00129623|B3|Baseline|Total|Total of all reporting groups
728235|NCT00129623|B2|Baseline|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728236|NCT00129623|B1|Baseline|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728237|NCT00129623|P2|Participant Flow|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728238|NCT00129623|P1|Participant Flow|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728239|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728240|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728241|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728242|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728243|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia who were administered 150 mg IBN tablet orally (PO) once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
728244|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia who were administered matching placebo tablet PO once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
728245|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728246|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728272|NCT00129545|E2|Reported Event|WATCHMAN|Randomized to receive implantation of the WATCHMAN LAA closure Device
728273|NCT00129545|E1|Reported Event|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
728247|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728248|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728249|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728250|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728251|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728252|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728253|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728254|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728255|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728256|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728257|NCT00129623|E2|Reported Event|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728258|NCT00129623|E1|Reported Event|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
728259|NCT00129545|B4|Baseline|Total|Total of all reporting groups
728260|NCT00129545|B3|Baseline|Roll-in|Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
728261|NCT00129545|B2|Baseline|Warfarin Control|Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
728262|NCT00129545|B1|Baseline|WATCHMAN|WATCHMAN Left Atrial Appendage Closure Technology:
728263|NCT00129545|P3|Participant Flow|WARFARIN|Randomized to receive Warfarin control
728264|NCT00129545|P2|Participant Flow|WATCHMAN|Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology
728265|NCT00129545|P1|Participant Flow|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
728266|NCT00129545|O1|Outcome|WATCHMAN|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~Implant of WATCHMAN Left Atrial Appendage Closure Technology"
728267|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin~Warfarin: Subjects receive warfarin"
728268|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
728269|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin~Warfarin: Subjects receive warfarin"
728270|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
728271|NCT00129545|E3|Reported Event|WARFARIN|Randomized to receive Warfarin control
728274|NCT00129480|B3|Baseline|Total|Total of all reporting groups
728275|NCT00129480|B2|Baseline|Treatment as Usual|Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services
728276|NCT00129480|B1|Baseline|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
728277|NCT00129480|P2|Participant Flow|Treatment as Usual|Treatment as usual
728278|NCT00129480|P1|Participant Flow|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
728279|NCT00129480|O2|Outcome|Treatment as Usual|Pain treatment as usual
728280|NCT00129480|O1|Outcome|Assistance With Pain Treatment (Intervention)|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
728281|NCT00129480|E2|Reported Event|Treatment as Usual|Treatment as usual, which includes standard pain care, clinician-generated referrals for additional consultation and ancillary services
728282|NCT00129480|E1|Reported Event|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
728283|NCT00129467|B3|Baseline|Total|Total of all reporting groups
728284|NCT00129467|B2|Baseline|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
728285|NCT00129467|B1|Baseline|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
728286|NCT00129467|P2|Participant Flow|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
728287|NCT00129467|P1|Participant Flow|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
728288|NCT00129467|O2|Outcome|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
728289|NCT00129467|O1|Outcome|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
728290|NCT00129467|E2|Reported Event|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
728291|NCT00129467|E1|Reported Event|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
728292|NCT00129441|B3|Baseline|Total|Total of all reporting groups
728293|NCT00129441|B2|Baseline|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728294|NCT00129441|B1|Baseline|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728295|NCT00129441|P2|Participant Flow|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728296|NCT00129441|P1|Participant Flow|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728297|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728298|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728299|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728300|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728301|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728302|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728303|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728304|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728305|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728306|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728307|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728308|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728309|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728310|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728311|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728312|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728313|NCT00129441|E2|Reported Event|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
728314|NCT00129441|E1|Reported Event|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
728315|NCT00129402|B3|Baseline|Total|Total of all reporting groups
728316|NCT00129402|B2|Baseline|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728317|NCT00129402|B1|Baseline|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728318|NCT00129402|P7|Participant Flow|Long-term Experience Ezetimbe/Simvastatin|Subjects who received long-term coadministration of ezetimibe with simvastatin once daily
728319|NCT00129402|P6|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 40|Subjects who received simvastatin monotherapy 40 mg once daily
728320|NCT00129402|P5|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 20|Subjects who received simvastatin monotherapy 20 mg once daily
728321|NCT00129402|P4|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 10|Subjects who received simvastatin monotherapy 10 mg once daily
728322|NCT00129402|P3|Participant Flow|Ezetimibe/Simvastatin 10/40|Subjects who received ezetimibe 10 mg plus simvastatin 40 mg once daily
728323|NCT00129402|P2|Participant Flow|Ezetimibe/Simvastatin 10/20|Subjects who received ezetimibe 10 mg with simvastatin 10 mg once daily
728324|NCT00129402|P1|Participant Flow|Ezetimibe/Simvastatin 10/10|Subjects who received ezetimibe 10 mg plus simvastatin 10 mg once daily
728325|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728326|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728327|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728328|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728329|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728360|NCT00129285|O1|Outcome|Low Dose Modafinil|"Low Dose Modafinil~Modafinil Low Dose: participants received modafinil 200 mg/day"
728330|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728331|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728332|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728333|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|pooled subjects who received simvastatin 10 mg monotherapy, simvastatin 20 mg monotherapy, or simvastatin 40 mg monotherapy
728334|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728335|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728336|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
728337|NCT00129402|E3|Reported Event|Long-term Coadministration of Ezetimibe With Simvastatin|"Column 3 provides the combined AE data collected for~all subjects that participated during Period 3. One subject who entered Period 3 did not receive study medication and was not included in the analysis."
728338|NCT00129402|E2|Reported Event|Simvastatin Monotherapy|"Column 2 provides the combined AE data collected for subjects in the simvastatin monotherapy treatment~groups during Period 1 and Period 2."
728339|NCT00129402|E1|Reported Event|Ezetimibe With Simvastatin|Column 1 provides the combined AE data collected for subjects in the ezetimibe with simvastatin treatment groups during Period 1 and Period 2
728340|NCT00129311|B3|Baseline|Total|Total of all reporting groups
728341|NCT00129311|B2|Baseline|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728342|NCT00129311|B1|Baseline|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728343|NCT00129311|P2|Participant Flow|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728344|NCT00129311|P1|Participant Flow|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728345|NCT00129311|O2|Outcome|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728346|NCT00129311|O1|Outcome|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728347|NCT00129311|O2|Outcome|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728348|NCT00129311|O1|Outcome|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728349|NCT00129311|E2|Reported Event|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728350|NCT00129311|E1|Reported Event|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
728351|NCT00129285|B4|Baseline|Total|Total of all reporting groups
728352|NCT00129285|B3|Baseline|Placebo|"Placebo~Placebo: placebo 400 mg/day"
728353|NCT00129285|B2|Baseline|High Dose Modafinil|"High Dose Modafinil~Modafinil High Dose: modafinil 400 mg/day"
728354|NCT00129285|B1|Baseline|Low Dose Modafinil|"Low Dose Modafinil~Modafinil Low Dose: modafinil 200 mg/day"
728355|NCT00129285|P3|Participant Flow|Placebo|"Placebo~Placebo: participants received placebo 400 mg/day"
728356|NCT00129285|P2|Participant Flow|High Dose Modafinil|"High Dose Modafinil~Modafinil High Dose: participants received modafinil 400 mg/day"
728357|NCT00129285|P1|Participant Flow|Low Dose Modafinil|"Low Dose Modafinil~Modafinil Low Dose: participants received modafinil 200 mg/day"
728358|NCT00129285|O3|Outcome|Placebo|received placebo
728359|NCT00129285|O2|Outcome|High Dose Modafinil|"High Dose Modafinil~Modafinil High Dose: participants received modafinil 400 mg/day"
728362|NCT00129285|O2|Outcome|2 High Dose Modafinil|"High Dose Modafinil 400 mg daily~Modafinil High Dose: modafinil 400 mg/day"
728363|NCT00129285|O1|Outcome|1Low Dose Modafinil|"Low Dose Modafinil 200 mg daily~Modafinil Low Dose: modafinil 200 mg/day"
728364|NCT00129285|O3|Outcome|Placebo|"Placebo~Placebo: participants received placebo 400 mg/day"
728365|NCT00129285|O2|Outcome|High Dose Modafinil|"High Dose Modafinil~Modafinil High Dose: participants received modafinil 400 mg/day"
728366|NCT00129285|O1|Outcome|Low Dose Modafinil|"Low Dose Modafinil~Modafinil Low Dose: participants received modafinil 200 mg/day"
728367|NCT00129285|E3|Reported Event|Modafinil Low Dose|modafinil 200 mg daily
728368|NCT00129285|E2|Reported Event|Placebo|Placebo daily
728369|NCT00129285|E1|Reported Event|Modafinil High Dose|Modafinil 400 mg daily
728370|NCT00129272|B3|Baseline|Total|Total of all reporting groups
728371|NCT00129272|B2|Baseline|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
728372|NCT00129272|B1|Baseline|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
728373|NCT00129272|P2|Participant Flow|Matching Placebo|"This arm included placebo treatment twice daily for 9 weeks. Drug and placebo were compounded to look identical, masking both drug type and dosage.~All participants (both drug and placebo groups) received a modified version of the brief office intervention program for adolescent smokers, developed by the American Medical Association. Subjects met with a research counselor for 10 consecutive weekly sessions. The initial session (baseline visit) was 60 min. while the remaining sessions were 20-30 min. Each session was individualized to the needs of the adolescent, based on information gathered at the baseline assessment. The brief office intervention materials include checklists and guidelines for each session to assist the counselor in tailoring the session to the needs of the youth. It involved motivational interviewing, incorporating stages of change, peer and parental and other social influences; negative affect and other psychological factors, addiction and self-efficacy."
728374|NCT00129272|P1|Participant Flow|Active Drug (Burpropion-SR)|"In total 172 participants were recruited, and 144 were randomized.~Using a double-blind, randomized, placebo-controlled design, participants were randomized to active drug or placebo using the modified Efron’s biased coin toss method to ensure that the drug/placebo cells are balanced with respect to severe depression, presence of nicotine dependence symptoms and gender.~Participants received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~The participants had weekly visits with the target quitting date set for Day 8. The medication checks lasted about 30-45 minutes. The focus was on elicitation of smoking status, nicotine craving and withdrawal symptoms, depressive symptoms and side effects. Body weight and vital signs were measured as well as expired air for CO and urine cotinine levels. Plasma drug levels were obtained at 5 and 9 weeks of treatment."
728375|NCT00129272|O2|Outcome|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
728376|NCT00129272|O1|Outcome|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
728377|NCT00129272|O2|Outcome|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
728378|NCT00129272|O1|Outcome|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
728379|NCT00129272|E2|Reported Event|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
728380|NCT00129272|E1|Reported Event|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
728381|NCT00129259|B3|Baseline|Total|Total of all reporting groups
728382|NCT00129259|B2|Baseline|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728383|NCT00129259|B1|Baseline|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728411|NCT00129220|B2|Baseline|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728384|NCT00129259|P2|Participant Flow|Diabetes Standard of Care Treatment|"Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
728385|NCT00129259|P1|Participant Flow|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|"Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
728386|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728387|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728388|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728389|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728390|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728391|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728392|NCT00129259|E2|Reported Event|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728393|NCT00129259|E1|Reported Event|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
728394|NCT00129246|B3|Baseline|Total|Total of all reporting groups
728395|NCT00129246|B2|Baseline|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728396|NCT00129246|B1|Baseline|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728397|NCT00129246|P2|Participant Flow|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728398|NCT00129246|P1|Participant Flow|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728399|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728400|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728401|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728402|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728403|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728404|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728405|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728406|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728407|NCT00129246|E2|Reported Event|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728408|NCT00129246|E1|Reported Event|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
728409|NCT00129220|B4|Baseline|Total|Total of all reporting groups
728412|NCT00129220|B1|Baseline|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728413|NCT00129220|P3|Participant Flow|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728414|NCT00129220|P2|Participant Flow|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728415|NCT00129220|P1|Participant Flow|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728416|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728417|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728418|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728419|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728420|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728421|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728422|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728423|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728424|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728425|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728426|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728427|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728428|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728429|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728430|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728431|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728432|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728433|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728434|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728435|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728436|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728437|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728438|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728439|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728440|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day
728441|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day
728442|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728443|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728444|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728445|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728446|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728447|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728448|NCT00129220|E3|Reported Event|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
728449|NCT00129220|E2|Reported Event|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
728450|NCT00129220|E1|Reported Event|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
728451|NCT00129129|B4|Baseline|Total|Total of all reporting groups
728452|NCT00129129|B3|Baseline|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728453|NCT00129129|B2|Baseline|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728454|NCT00129129|B1|Baseline|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh..
728455|NCT00129129|P5|Participant Flow|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728456|NCT00129129|P4|Participant Flow|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
728974|NCT00128713|P1|Participant Flow|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728457|NCT00129129|P3|Participant Flow|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728458|NCT00129129|P2|Participant Flow|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728459|NCT00129129|P1|Participant Flow|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728460|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728461|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728462|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728463|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728464|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728465|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728466|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728467|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728479|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728975|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728468|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728469|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728470|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728471|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728472|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728473|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728474|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728475|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728476|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728477|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728478|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728976|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728977|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
743402|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
728480|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728481|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728482|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728483|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728484|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
728485|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728486|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728487|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728488|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728489|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728490|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728491|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728492|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728493|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728494|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728495|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728496|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728497|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728498|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728499|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728500|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728501|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728502|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728978|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728979|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
743403|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
728503|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728504|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728505|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728506|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728507|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728508|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728509|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728510|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728511|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728512|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728513|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728980|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728981|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
743404|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
728514|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728515|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728516|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728517|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728518|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728519|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728520|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728521|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728522|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728523|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728524|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728548|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728982|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728983|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728525|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728526|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728527|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728528|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728529|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728530|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728531|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
728532|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728533|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728534|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728535|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
728536|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728984|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728537|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728538|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728539|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728540|NCT00129129|O1|Outcome|Menhibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728541|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728542|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728543|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728544|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728545|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728546|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728547|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728570|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
743405|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
728549|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728550|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728551|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728552|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728553|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
728554|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728555|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
728556|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728557|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728558|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728559|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728560|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728985|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728561|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728562|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728563|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728564|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728565|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728566|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728567|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728568|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728569|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728571|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728572|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728573|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728574|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728575|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728576|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728577|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728578|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728579|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728672|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728580|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728581|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728582|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728583|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728584|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728585|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728586|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728587|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728588|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
729710|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
728589|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728590|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728591|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728592|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728593|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728594|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728595|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728596|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728597|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728598|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728599|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728600|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728601|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728602|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728603|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728604|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728605|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728606|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
729711|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
728607|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728608|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728609|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728610|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728611|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728612|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728613|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728614|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728615|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728986|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
743406|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
728616|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728617|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728618|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728619|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728620|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728621|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728622|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728623|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728624|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728625|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728626|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728987|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728988|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728989|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728627|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728628|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728629|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728630|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728631|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728632|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728633|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728634|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728635|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728636|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728637|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728990|NCT00128713|E3|Reported Event|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728991|NCT00128713|E2|Reported Event|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728638|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728639|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728640|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728641|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728642|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728643|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728644|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728645|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728646|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728647|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728673|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728992|NCT00128713|E1|Reported Event|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728993|NCT00128661|B3|Baseline|Total|Total of all reporting groups
728648|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728649|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728650|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728651|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728652|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728653|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728654|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728655|NCT00129129|E5|Reported Event|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728656|NCT00129129|E4|Reported Event|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
728657|NCT00129129|E3|Reported Event|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
728658|NCT00129129|E2|Reported Event|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
728674|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728659|NCT00129129|E1|Reported Event|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
728660|NCT00129116|B6|Baseline|Total|Total of all reporting groups
728661|NCT00129116|B5|Baseline|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728662|NCT00129116|B4|Baseline|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728663|NCT00129116|B3|Baseline|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728664|NCT00129116|B2|Baseline|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728665|NCT00129116|B1|Baseline|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728666|NCT00129116|P5|Participant Flow|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728667|NCT00129116|P4|Participant Flow|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728668|NCT00129116|P3|Participant Flow|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728669|NCT00129116|P2|Participant Flow|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728670|NCT00129116|P1|Participant Flow|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728671|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728952|NCT00128921|E1|Reported Event|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
728953|NCT00128830|B1|Baseline|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
743407|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
728675|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728676|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728677|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728678|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728679|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728680|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728681|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728682|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728683|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728684|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728685|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728686|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728687|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728954|NCT00128830|P1|Participant Flow|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
743408|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
728688|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728689|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728690|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728691|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728692|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728693|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728694|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728695|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728696|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728697|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728698|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728699|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728700|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728955|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
728701|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728702|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728703|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728704|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728705|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728706|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728707|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728708|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728709|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728710|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728711|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728712|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728713|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728956|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
743409|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
728714|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728715|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728716|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728717|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728718|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728719|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728720|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728721|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728722|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728723|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728724|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728725|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728726|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728957|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
743410|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
728727|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728728|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728729|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728730|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728731|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728732|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728733|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728734|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728735|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728736|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728737|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728738|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728739|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728958|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
743411|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
728740|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728741|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728742|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728743|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728744|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728745|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728746|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728747|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728748|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728749|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728750|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728751|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728752|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728959|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
743412|NCT00091507|E2|Reported Event|Placebo|Dextrose 5%
728753|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728754|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728755|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728756|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728757|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728758|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728759|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728760|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728761|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728762|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728763|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728764|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728765|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728960|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
728766|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728767|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728768|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728769|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728770|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728771|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728772|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728773|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728774|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728775|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728776|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728777|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728778|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728961|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
744800|NCT00087672|E1|Reported Event|CC-5013|10 mg orally daily
728779|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728780|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728781|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728782|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728783|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728784|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728785|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728786|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728787|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728788|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728789|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728790|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728791|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728962|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
744801|NCT00087646|B5|Baseline|Total|Total of all reporting groups
728792|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728793|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728794|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728795|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728796|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728797|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728798|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728799|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728800|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728801|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728802|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728803|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728804|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728963|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
730184|NCT00125931|P1|Participant Flow|Treatment Group|Open label group with pentazocine treatment.
728805|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728806|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728807|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728808|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728809|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728810|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728811|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728812|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728813|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728814|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728815|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728816|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728817|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728964|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
730827|NCT00123955|O1|Outcome|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
728818|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728819|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728820|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728821|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728822|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728823|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728824|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728825|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728826|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728827|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728828|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728829|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728830|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728965|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
747208|NCT00077064|O2|Outcome|Captopril|Captopril: 50 mg t.i.d.
728831|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728832|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728833|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728834|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728835|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728836|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728837|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728838|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728839|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728840|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728841|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728842|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728843|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728966|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
730828|NCT00123955|O2|Outcome|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
728844|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728845|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728846|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728847|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728848|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728849|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728850|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728851|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728852|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728853|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728854|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728855|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728856|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728967|NCT00128830|E1|Reported Event|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
728968|NCT00128713|B4|Baseline|Total|Total of all reporting groups
728857|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728858|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728859|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728860|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728861|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728862|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728863|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728864|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728865|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728866|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728867|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728868|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728869|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728969|NCT00128713|B3|Baseline|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
747209|NCT00077064|O1|Outcome|Clinical Observation|Clinical observation
728870|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728871|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728872|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728873|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728874|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728875|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728876|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728877|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728878|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728879|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728880|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728881|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728882|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728970|NCT00128713|B2|Baseline|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
747210|NCT00077064|O2|Outcome|Captopril|Captopril: 50 mg t.i.d.
728883|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728884|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728885|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728886|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728887|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728888|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728889|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728890|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728891|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728892|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728893|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728894|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728895|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728971|NCT00128713|B1|Baseline|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
728896|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728897|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728898|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728899|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728900|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728901|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728902|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728903|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728904|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728905|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728906|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728907|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728908|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728972|NCT00128713|P3|Participant Flow|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
747211|NCT00077064|O1|Outcome|Clinical Observation|Clinical observation
728909|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728910|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728911|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728912|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728913|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728914|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728915|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728916|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728917|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728918|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728919|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728920|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728921|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728973|NCT00128713|P2|Participant Flow|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
747212|NCT00077064|O2|Outcome|Captopril|Captopril: 50 mg t.i.d.
728922|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728923|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728924|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728925|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728926|NCT00129116|E5|Reported Event|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728927|NCT00129116|E4|Reported Event|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728928|NCT00129116|E3|Reported Event|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728929|NCT00129116|E2|Reported Event|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728930|NCT00129116|E1|Reported Event|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
728931|NCT00128921|B4|Baseline|Total|Total of all reporting groups
728932|NCT00128921|B3|Baseline|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
728933|NCT00128921|B2|Baseline|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
728934|NCT00128921|B1|Baseline|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
728935|NCT00128921|P3|Participant Flow|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
728936|NCT00128921|P2|Participant Flow|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
728937|NCT00128921|P1|Participant Flow|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
728938|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
728939|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
728940|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
728941|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
728942|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
728943|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
728944|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11).
728945|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
728946|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
728947|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
728948|NCT00128921|O2|Outcome|Cohort B|Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
728949|NCT00128921|O1|Outcome|Cohort A|Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
728950|NCT00128921|E3|Reported Event|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
728951|NCT00128921|E2|Reported Event|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
728994|NCT00128661|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
728995|NCT00128661|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
728996|NCT00128661|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
728997|NCT00128661|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
728998|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
728999|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729000|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729001|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729002|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729003|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729004|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729005|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729006|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729007|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729008|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729009|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729010|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729011|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729012|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729013|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729014|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729015|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729016|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729017|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729018|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729019|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729020|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729021|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729022|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729023|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729024|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729025|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729026|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729027|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729028|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729029|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729030|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729031|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729032|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729033|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729034|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729035|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729036|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729037|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729038|NCT00128661|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729039|NCT00128661|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
729040|NCT00128492|B3|Baseline|Total|Total of all reporting groups
729041|NCT00128492|B2|Baseline|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729042|NCT00128492|B1|Baseline|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729043|NCT00128492|P2|Participant Flow|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729044|NCT00128492|P1|Participant Flow|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729045|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729046|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729047|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729048|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729049|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729050|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729051|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729052|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729053|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729712|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729054|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729055|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729056|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729057|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729058|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729059|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729060|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729061|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729062|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729063|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729064|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729065|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729066|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729067|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729068|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729069|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729070|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729071|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729072|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729073|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729074|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729075|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729076|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729077|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729141|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729078|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729079|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729080|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729081|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729082|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729083|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729084|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729085|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729086|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729087|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729088|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729089|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729090|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729091|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729092|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729093|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729094|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729095|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729096|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729097|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729098|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729099|NCT00128492|E2|Reported Event|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
729100|NCT00128492|E1|Reported Event|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
729101|NCT00128401|B3|Baseline|Total|Total of all reporting groups
729102|NCT00128401|B2|Baseline|Placebo|
729103|NCT00128401|B1|Baseline|D-cycloserine|
729142|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729713|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729104|NCT00128401|P2|Participant Flow|Placebo|"Subjects were randomized to receive cognitive behavioral therapy with augmentation of placebo administered on day of therapy session.~All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent."
729105|NCT00128401|P1|Participant Flow|D-cycloserine|Subjects were randomized to receive cognitive behavioral therapy with augmentation of D-cycloserine 50 mg administered on day of therapy session. All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent.
729106|NCT00128401|O2|Outcome|Placebo|
729107|NCT00128401|O1|Outcome|D-cycloserine|
729108|NCT00128401|O2|Outcome|Placebo|
729109|NCT00128401|O1|Outcome|D-cycloserine|
729110|NCT00128401|E3|Reported Event|Not Assigned|
729111|NCT00128401|E2|Reported Event|Placebo|
729112|NCT00128401|E1|Reported Event|D-cycloserine|
729113|NCT00128219|B3|Baseline|Total|Total of all reporting groups
729114|NCT00128219|B2|Baseline|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729115|NCT00128219|B1|Baseline|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729116|NCT00128219|P2|Participant Flow|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729117|NCT00128219|P1|Participant Flow|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729118|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729119|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729120|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729121|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729122|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729123|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729124|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729125|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729126|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729127|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729128|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729129|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729130|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729131|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729132|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729133|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729134|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729135|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729136|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729137|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729138|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729139|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729140|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729248|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729143|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729144|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729145|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729146|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729147|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729148|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729149|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729150|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729151|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729152|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729153|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729154|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729155|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729156|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729157|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729158|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729159|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729160|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729161|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729162|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729163|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729164|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729165|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729166|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729167|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729168|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729169|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729170|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729171|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729172|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729173|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729174|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729175|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729176|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729177|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729178|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
747213|NCT00077064|O1|Outcome|Observation|Clinical observation
729179|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729180|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729181|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729182|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729183|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729184|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729185|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729186|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729187|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729188|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729189|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729190|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729191|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729192|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729193|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729194|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
729195|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
729196|NCT00128219|E2|Reported Event|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
729197|NCT00128219|E1|Reported Event|GBS III-TT Vaccine|The experimental arm received a single dose of GBS III-TT vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
729198|NCT00128206|B3|Baseline|Total|Total of all reporting groups
729199|NCT00128206|B2|Baseline|Rifampin|rifampin (600 mg orally) given daily for 4 months
729200|NCT00128206|B1|Baseline|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
729201|NCT00128206|P2|Participant Flow|Rifampin|rifampin (600 mg orally) given daily for 4 months
729202|NCT00128206|P1|Participant Flow|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
729203|NCT00128206|O2|Outcome|Rifampin|rifampin (600 mg orally) given daily for 4 months
729204|NCT00128206|O1|Outcome|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
729205|NCT00128206|E2|Reported Event|Rifampin|rifampin (600 mg orally) given daily for 4 months
729206|NCT00128206|E1|Reported Event|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
729207|NCT00128193|B13|Baseline|Total|Total of all reporting groups
729208|NCT00128193|B12|Baseline|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729209|NCT00128193|B11|Baseline|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729210|NCT00128193|B10|Baseline|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729211|NCT00128193|B9|Baseline|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729212|NCT00128193|B8|Baseline|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729213|NCT00128193|B7|Baseline|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729214|NCT00128193|B6|Baseline|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729215|NCT00128193|B5|Baseline|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729216|NCT00128193|B4|Baseline|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729217|NCT00128193|B3|Baseline|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729218|NCT00128193|B2|Baseline|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729219|NCT00128193|B1|Baseline|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729220|NCT00128193|P12|Participant Flow|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729221|NCT00128193|P11|Participant Flow|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729222|NCT00128193|P10|Participant Flow|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729223|NCT00128193|P9|Participant Flow|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729224|NCT00128193|P8|Participant Flow|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729225|NCT00128193|P7|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729226|NCT00128193|P6|Participant Flow|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729227|NCT00128193|P5|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729228|NCT00128193|P4|Participant Flow|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729229|NCT00128193|P3|Participant Flow|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729230|NCT00128193|P2|Participant Flow|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729231|NCT00128193|P1|Participant Flow|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729232|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729233|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729234|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729235|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729236|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729237|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729238|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729239|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729240|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729241|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729242|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729243|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729244|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729245|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729246|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729247|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729788|NCT00127660|B1|Baseline|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
729249|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729250|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729251|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729252|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729253|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729254|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729255|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729256|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729257|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729258|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729259|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729260|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729261|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729262|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729263|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729264|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729265|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729266|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729267|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729268|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729269|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729270|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729271|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729272|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729273|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729274|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729275|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729276|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729277|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729278|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729279|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729280|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729281|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729282|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729283|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729284|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729285|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729286|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729287|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729288|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729289|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729290|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729291|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729292|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729293|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729294|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729295|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729296|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729297|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729298|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729299|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729300|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729301|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729302|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729303|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729304|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729305|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729306|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729307|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729308|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729309|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729310|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729311|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729312|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729313|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729314|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729315|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729316|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729317|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729318|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729319|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729320|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729321|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729322|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729323|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729324|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729325|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729326|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729327|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729328|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729329|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729330|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729331|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729332|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729333|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729334|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729335|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729336|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729337|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729338|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729339|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729340|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729341|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729342|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729343|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729344|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729345|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729346|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729347|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729348|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729349|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729350|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729351|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729352|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729353|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729354|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729355|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729356|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729357|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729358|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729359|NCT00128193|O3|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729360|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729361|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729362|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729363|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729364|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729365|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729366|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729367|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729368|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729369|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729370|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729371|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729372|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729373|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729374|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729375|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729376|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729377|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729378|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729379|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729380|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729381|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729382|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729383|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729384|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729385|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729386|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729387|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729388|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729389|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729390|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729391|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729392|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729393|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
729394|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729395|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729396|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729397|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729398|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729399|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729400|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729401|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729402|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729403|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729404|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729405|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729406|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729407|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729408|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729409|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729410|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729714|NCT00127842|E1|Reported Event|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729411|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729412|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729413|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729414|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729415|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729416|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729417|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729418|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729419|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729420|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729421|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729422|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729423|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729424|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729425|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729426|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729427|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729428|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729429|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729430|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729431|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729432|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729433|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729434|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729435|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729436|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729437|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729438|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729439|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729440|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729441|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729442|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729715|NCT00127803|B5|Baseline|Total|Total of all reporting groups
729443|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729444|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729445|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729446|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729447|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729448|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729449|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729450|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729451|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729452|NCT00128193|E12|Reported Event|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729453|NCT00128193|E11|Reported Event|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729454|NCT00128193|E10|Reported Event|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
729455|NCT00128193|E9|Reported Event|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
729456|NCT00128193|E8|Reported Event|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729457|NCT00128193|E7|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729458|NCT00128193|E6|Reported Event|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729459|NCT00128193|E5|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
729460|NCT00128193|E4|Reported Event|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729461|NCT00128193|E3|Reported Event|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729462|NCT00128193|E2|Reported Event|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
729463|NCT00128193|E1|Reported Event|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
729464|NCT00128180|B3|Baseline|Total|Total of all reporting groups
729465|NCT00128180|B2|Baseline|Placebo|Placebo group
729466|NCT00128180|B1|Baseline|Active|Active drug
729467|NCT00128180|P2|Participant Flow|Placebo|Placebo group
729468|NCT00128180|P1|Participant Flow|Active|Active drug
729469|NCT00128180|O2|Outcome|Placebo|Placebo group
729470|NCT00128180|O1|Outcome|Active|Active drug
729471|NCT00128180|O2|Outcome|Placebo|Placebo group
729472|NCT00128180|O1|Outcome|Active|Active drug
729473|NCT00128180|O2|Outcome|Placebo|Placebo group
729474|NCT00128180|O1|Outcome|Active|Active drug
729475|NCT00128180|O2|Outcome|Placebo|Placebo group
729476|NCT00128180|O1|Outcome|Active|Active drug
729477|NCT00128180|O2|Outcome|Placebo|Placebo group
729478|NCT00128180|O1|Outcome|Active|Active drug
729479|NCT00128180|O2|Outcome|Placebo|Placebo group
729480|NCT00128180|O1|Outcome|Active|Active drug
729481|NCT00128180|O2|Outcome|Placebo|Placebo group
729482|NCT00128180|O1|Outcome|Active|Active drug
729483|NCT00128180|O2|Outcome|Placebo|Placebo group
729484|NCT00128180|O1|Outcome|Active|Active drug
729485|NCT00128180|O2|Outcome|Placebo|Placebo group
729486|NCT00128180|O1|Outcome|Active|Active drug
729487|NCT00128180|O2|Outcome|Placebo|Placebo group
729488|NCT00128180|O1|Outcome|Active|Active drug
729489|NCT00128180|E2|Reported Event|Placebo|Placebo group
729490|NCT00128180|E1|Reported Event|Active|Active drug
729491|NCT00127933|B3|Baseline|Total|Total of all reporting groups
729536|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729492|NCT00127933|B2|Baseline|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729493|NCT00127933|B1|Baseline|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729494|NCT00127933|P2|Participant Flow|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729495|NCT00127933|P1|Participant Flow|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729496|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729497|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729498|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729499|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729500|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729501|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729502|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729503|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729504|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729505|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729506|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729507|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729508|NCT00127933|E2|Reported Event|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
729509|NCT00127933|E1|Reported Event|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
729510|NCT00127855|B6|Baseline|Total|Total of all reporting groups
729511|NCT00127855|B5|Baseline|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729512|NCT00127855|B4|Baseline|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729513|NCT00127855|B3|Baseline|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729514|NCT00127855|B2|Baseline|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729515|NCT00127855|B1|Baseline|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729516|NCT00127855|P5|Participant Flow|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729517|NCT00127855|P4|Participant Flow|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729518|NCT00127855|P3|Participant Flow|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729519|NCT00127855|P2|Participant Flow|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729520|NCT00127855|P1|Participant Flow|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729521|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729522|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729523|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729524|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729525|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729526|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729527|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729528|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729529|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729530|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729531|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729532|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729533|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729534|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729535|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729537|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729538|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729539|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729540|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729541|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729542|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729543|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729544|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729545|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729546|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729547|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729548|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729549|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729550|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729551|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729552|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729553|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729554|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729555|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729556|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729557|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
730829|NCT00123955|O1|Outcome|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
729558|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729559|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729560|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729561|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729562|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729563|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729564|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729565|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729566|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729567|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729568|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729569|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729570|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729571|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729572|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729573|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729574|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729575|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729576|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729577|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729578|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
747214|NCT00077064|E2|Reported Event|Captopril|Captopril: 50 mg t.i.d.
729579|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729580|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729581|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729582|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729583|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729584|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729585|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729586|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729587|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729588|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729589|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729590|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729591|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729592|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729593|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729594|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729595|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729596|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729597|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729598|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729599|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
747216|NCT00076999|B5|Baseline|Total|Total of all reporting groups
729600|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729601|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729602|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729603|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729604|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729605|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729606|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729607|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729608|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729609|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729610|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729611|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729612|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729613|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729614|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729615|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729616|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729617|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729618|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729619|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729620|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
747649|NCT00075803|B1|Baseline|Fluconazole|fluconazole prophylaxis
729621|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729622|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729623|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729624|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729625|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729626|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729627|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729628|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729629|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729630|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729631|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729632|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729633|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729634|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729635|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729636|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729637|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729638|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729639|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729640|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729641|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
730830|NCT00123955|O2|Outcome|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
729642|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729643|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729644|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729645|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729646|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729647|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729648|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729649|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729650|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729651|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729652|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729653|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729654|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729655|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729656|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729657|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729658|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729659|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729660|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729661|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729662|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
730831|NCT00123955|O1|Outcome|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
729663|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729664|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729665|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729666|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729667|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729668|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729669|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729670|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729671|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729672|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729673|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729674|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729675|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729676|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729677|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729678|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729679|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729680|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729681|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729682|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729683|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
747652|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
729684|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729685|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729686|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729687|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729688|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729689|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729690|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729691|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729692|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729693|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729694|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729695|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729696|NCT00127855|E5|Reported Event|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729697|NCT00127855|E4|Reported Event|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729698|NCT00127855|E3|Reported Event|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729699|NCT00127855|E2|Reported Event|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729700|NCT00127855|E1|Reported Event|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
729701|NCT00127842|B1|Baseline|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729702|NCT00127842|P1|Participant Flow|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729703|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729704|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729705|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729706|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729707|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729708|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
729709|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
747653|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
729716|NCT00127803|B4|Baseline|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
729717|NCT00127803|B3|Baseline|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
729718|NCT00127803|B2|Baseline|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
729719|NCT00127803|B1|Baseline|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
729720|NCT00127803|P4|Participant Flow|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
729721|NCT00127803|P3|Participant Flow|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
729722|NCT00127803|P2|Participant Flow|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
729723|NCT00127803|P1|Participant Flow|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
729724|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
729725|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
729726|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
729727|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
729728|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
729729|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
729730|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
729731|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
729732|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
729733|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
729734|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
729735|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
729736|NCT00127803|E4|Reported Event|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
729737|NCT00127803|E3|Reported Event|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
729738|NCT00127803|E2|Reported Event|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
729739|NCT00127803|E1|Reported Event|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
729740|NCT00127790|B5|Baseline|Total|Total of all reporting groups
729741|NCT00127790|B4|Baseline|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
729742|NCT00127790|B3|Baseline|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729743|NCT00127790|B2|Baseline|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729744|NCT00127790|B1|Baseline|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
729745|NCT00127790|P4|Participant Flow|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
729746|NCT00127790|P3|Participant Flow|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729747|NCT00127790|P2|Participant Flow|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729748|NCT00127790|P1|Participant Flow|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
729749|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
729750|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729751|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
747654|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
729752|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
729753|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
729754|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729755|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729756|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
729757|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
729758|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729759|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729760|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
729761|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
729762|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729763|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729764|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
729765|NCT00127790|E4|Reported Event|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
729766|NCT00127790|E3|Reported Event|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729767|NCT00127790|E2|Reported Event|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
729768|NCT00127790|E1|Reported Event|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
729769|NCT00127712|B3|Baseline|Total|Total of all reporting groups
729770|NCT00127712|B2|Baseline|Control|Control group
729771|NCT00127712|B1|Baseline|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
729772|NCT00127712|P2|Participant Flow|Control|Control group
729773|NCT00127712|P1|Participant Flow|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
729774|NCT00127712|O2|Outcome|Control|Control group
729775|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
729776|NCT00127712|O2|Outcome|Control|Control group
729777|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
729778|NCT00127712|O2|Outcome|Control|Control group
729779|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
729780|NCT00127712|O2|Outcome|Control|Control group
729781|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
729782|NCT00127712|E2|Reported Event|Control|Control group
729783|NCT00127712|E1|Reported Event|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
729784|NCT00127660|B5|Baseline|Total|Total of all reporting groups
729785|NCT00127660|B4|Baseline|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
729786|NCT00127660|B3|Baseline|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
729787|NCT00127660|B2|Baseline|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
729789|NCT00127660|P4|Participant Flow|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
729790|NCT00127660|P3|Participant Flow|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
729791|NCT00127660|P2|Participant Flow|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
729792|NCT00127660|P1|Participant Flow|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
729793|NCT00127660|O4|Outcome|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
729794|NCT00127660|O3|Outcome|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
729795|NCT00127660|O2|Outcome|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
729796|NCT00127660|O1|Outcome|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
729797|NCT00127660|E4|Reported Event|Menu: Calories=no, Value Pricing = Yes|CONTROL CONDITION: calories not listed on menu, value pricing in place.
729798|NCT00127660|E3|Reported Event|Menu: Calories=no, Value Pricing = no|Calories not listed on menu, value pricing not in place
729799|NCT00127660|E2|Reported Event|Menu: Calories=Yes, Value Pricing = Yes|Calories listed on menu, value pricing in place.
729800|NCT00127660|E1|Reported Event|Menu: Calories=Yes, Value Pricing=no|Calories listed on menu, but value pricing was not in place.
729801|NCT00127530|B3|Baseline|Total|Total of all reporting groups
729802|NCT00127530|B2|Baseline|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
729803|NCT00127530|B1|Baseline|Placebo- Sugar Pill|Placebo control group
729804|NCT00127530|P2|Participant Flow|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
729805|NCT00127530|P1|Participant Flow|Placebo- Sugar Pill|Placebo control group
729806|NCT00127530|O2|Outcome|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
729807|NCT00127530|O1|Outcome|Placebo- Sugar Pill|Placebo control group
729808|NCT00127530|E2|Reported Event|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
729809|NCT00127530|E1|Reported Event|Placebo- Sugar Pill|Placebo control group
729810|NCT00127439|B3|Baseline|Total|Total of all reporting groups
729811|NCT00127439|B2|Baseline|Manually Assisted Locomotor Training|Manually Assisted Locomotor Training: The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred on a treadmill with partial body weight support and manual assist from 3-4 trainers to produce stepping and standing kinematics.
729812|NCT00127439|B1|Baseline|Robotic Assisted Locomotor Training|Robotic Assisted Locomotor Training - The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred using a robotic device to provide assistance for stepping and standing kinematics with partial body weight support on a treadmill.
729813|NCT00127439|P2|Participant Flow|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729814|NCT00127439|P1|Participant Flow|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729815|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729816|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729817|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729818|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729819|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|"A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.~The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs."
729820|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729849|NCT00127413|E3|Reported Event|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
729850|NCT00127413|E2|Reported Event|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
729821|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729822|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729823|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729824|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729825|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729826|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729827|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729828|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729829|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
729830|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729831|NCT00127439|O2|Outcome|Manually Assisted Locomotor Training|Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
729832|NCT00127439|O1|Outcome|Robotic Assisted Locomotor Training|Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
729833|NCT00127439|E2|Reported Event|Manually Assisted Locomotor Training|A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The therapist and trainers manually provide the appropriate kinematics associated with standing and stepping.
729834|NCT00127439|E1|Reported Event|Robotic Assisted Locomotor Training|A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.
729835|NCT00127413|B5|Baseline|Total|Total of all reporting groups
729836|NCT00127413|B4|Baseline|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
729837|NCT00127413|B3|Baseline|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
729838|NCT00127413|B2|Baseline|Cognitive Processing Therapy-PTSD|Cognitive processing therapy for PTSD
729839|NCT00127413|B1|Baseline|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
729840|NCT00127413|P4|Participant Flow|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
729841|NCT00127413|P3|Participant Flow|Cognitive Behavioral Therapy - Integrated|Integrated treatment for comorbid chronic pain and PTSD
729842|NCT00127413|P2|Participant Flow|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
729843|NCT00127413|P1|Participant Flow|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
729844|NCT00127413|O4|Outcome|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider
729845|NCT00127413|O3|Outcome|Cognitive Behavioral Therapy - Integrated|Cognitive Behavioral Therapy - Integrated treatment for pain and PTSD
729846|NCT00127413|O2|Outcome|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
729847|NCT00127413|O1|Outcome|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
729848|NCT00127413|E4|Reported Event|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
729851|NCT00127413|E1|Reported Event|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
729852|NCT00127231|B3|Baseline|Total|Total of all reporting groups
729853|NCT00127231|B2|Baseline|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729854|NCT00127231|B1|Baseline|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729855|NCT00127231|P2|Participant Flow|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729856|NCT00127231|P1|Participant Flow|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729857|NCT00127231|O2|Outcome|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729858|NCT00127231|O1|Outcome|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729859|NCT00127231|O2|Outcome|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729860|NCT00127231|O1|Outcome|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729861|NCT00127231|O2|Outcome|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729862|NCT00127231|O1|Outcome|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729863|NCT00127231|O2|Outcome|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729864|NCT00127231|O1|Outcome|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729865|NCT00127231|O2|Outcome|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729866|NCT00127231|O1|Outcome|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729867|NCT00127231|E2|Reported Event|2 Standard Care Arm|Standard care: Hazardous/binge female drinkers will be identified in the Johns Hopkins Hospital HIV clinic and will be randomized to brief intervention or standard care. Outcome measures will include: alcohol/drug use, engagement in an on-site alcohol support group and other substance abuse treatment services, HIV-risk behaviors, HIV disease markers and treatment compliance, and psychiatric symptoms.
729868|NCT00127231|E1|Reported Event|1 Brief Intervention|"The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content.~Brief alcohol intervention based on Project Treat: The brief intervention will include two sessions that review drinking patterns and behavior change strategies as well as two telephone calls to reinforce session content."
729869|NCT00127218|B3|Baseline|Total|Total of all reporting groups
747655|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
729870|NCT00127218|B2|Baseline|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729871|NCT00127218|B1|Baseline|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729872|NCT00127218|P2|Participant Flow|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729873|NCT00127218|P1|Participant Flow|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729874|NCT00127218|O2|Outcome|Any Statin Plus Placebo|"any statin plus placebo~any statin: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months~Placebo: matching placebo pill daily for 18 months"
729875|NCT00127218|O1|Outcome|Any Statin Plus Niacin|"any statin plus niacin~any statin: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months~niacin: long-acting niacin daily for 18 months"
729876|NCT00127218|O2|Outcome|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729877|NCT00127218|O1|Outcome|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729878|NCT00127218|E2|Reported Event|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729879|NCT00127218|E1|Reported Event|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
729880|NCT00127192|B6|Baseline|Total|Total of all reporting groups
729881|NCT00127192|B5|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
729882|NCT00127192|B4|Baseline|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
729883|NCT00127192|B3|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
729884|NCT00127192|B2|Baseline|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
729885|NCT00127192|B1|Baseline|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
729886|NCT00127192|P5|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
729887|NCT00127192|P4|Participant Flow|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
729888|NCT00127192|P3|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
729889|NCT00127192|P2|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
729890|NCT00127192|P1|Participant Flow|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
729891|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
729892|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
729893|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
729894|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
729895|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
729896|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
729897|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
729898|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
729899|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
729900|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
729901|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
729902|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
729938|NCT00127101|P3|Participant Flow|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
729903|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
729904|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
729905|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
729906|NCT00127192|E5|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
729907|NCT00127192|E4|Reported Event|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
729908|NCT00127192|E3|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
729909|NCT00127192|E2|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
729910|NCT00127192|E1|Reported Event|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
729911|NCT00127166|B3|Baseline|Total|Total of all reporting groups
729912|NCT00127166|B2|Baseline|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
729913|NCT00127166|B1|Baseline|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
729914|NCT00127166|P2|Participant Flow|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
729915|NCT00127166|P1|Participant Flow|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
729916|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
729917|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
729918|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
729919|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
729920|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
729921|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
729922|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
729923|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
729924|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
729925|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
729926|NCT00127166|E2|Reported Event|Salmeterol|"Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.~Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
729927|NCT00127166|E1|Reported Event|Montelukast|"Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.~Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
729928|NCT00127101|B7|Baseline|Total|Total of all reporting groups
729929|NCT00127101|B6|Baseline|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
729930|NCT00127101|B5|Baseline|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
729931|NCT00127101|B4|Baseline|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
729932|NCT00127101|B3|Baseline|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
729933|NCT00127101|B2|Baseline|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729934|NCT00127101|B1|Baseline|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729935|NCT00127101|P6|Participant Flow|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
729936|NCT00127101|P5|Participant Flow|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
729937|NCT00127101|P4|Participant Flow|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
729939|NCT00127101|P2|Participant Flow|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729940|NCT00127101|P1|Participant Flow|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729941|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
729942|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
729943|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
729944|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
729945|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729946|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729947|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
729948|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
729949|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
729950|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
729951|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729952|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729953|NCT00127101|E6|Reported Event|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
729954|NCT00127101|E5|Reported Event|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
729955|NCT00127101|E4|Reported Event|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
729956|NCT00127101|E3|Reported Event|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
729957|NCT00127101|E2|Reported Event|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729958|NCT00127101|E1|Reported Event|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
729959|NCT00127036|B3|Baseline|Total|Total of all reporting groups
729960|NCT00127036|B2|Baseline|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729961|NCT00127036|B1|Baseline|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729962|NCT00127036|P2|Participant Flow|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729963|NCT00127036|P1|Participant Flow|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729964|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729965|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729966|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729967|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729968|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729969|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729970|NCT00127036|E2|Reported Event|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729971|NCT00127036|E1|Reported Event|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
729972|NCT00126776|B3|Baseline|Total|Total of all reporting groups
729973|NCT00126776|B2|Baseline|Usual Care|usual care
729974|NCT00126776|B1|Baseline|Disease Management for COPD|disease management for COPD
729975|NCT00126776|P2|Participant Flow|Usual Care|usual care
729976|NCT00126776|P1|Participant Flow|Disease Management for COPD|disease management for COPD
729977|NCT00126776|O2|Outcome|Usual Care|usual care
729978|NCT00126776|O1|Outcome|Disease Management for COPD|disease management for COPD
729979|NCT00126750|B3|Baseline|Total|Total of all reporting groups
729980|NCT00126750|B2|Baseline|Control Arm/Group|Providers from eligible clinics that were allocated to the control arm.
730832|NCT00123955|O2|Outcome|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
729981|NCT00126750|B1|Baseline|Intervention Arm/Group|Providers from eligible clinics that were allocated to the intervention arm.
729982|NCT00126750|P2|Participant Flow|Control Group|Providers in control clinics were sent a link to an existing VA Web site that contained links to a wide range of clinical guidelines for various medical conditions.
729983|NCT00126750|P1|Participant Flow|Intervention Group|The intervention included a multicomponent Web site and pushed e-mail cues with educational content.
729984|NCT00126750|O2|Outcome|Control|Control Providers received a link to VA practice guidelines.
729985|NCT00126750|O1|Outcome|Intervention|Intervention Providers received an interactive, educational website and motivational reminders.
729986|NCT00126750|E2|Reported Event|Control Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
729987|NCT00126750|E1|Reported Event|Intervention Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
729988|NCT00126737|B5|Baseline|Total|Total of all reporting groups
729989|NCT00126737|B4|Baseline|Usual Care|Usual care and non-specific health information (C). No intervention.
729990|NCT00126737|B3|Baseline|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
729991|NCT00126737|B2|Baseline|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
729992|NCT00126737|B1|Baseline|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise Program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
729993|NCT00126737|P4|Participant Flow|Usual Care|Usual care and non-specific health information (C). No intervention.
729994|NCT00126737|P3|Participant Flow|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
729995|NCT00126737|P2|Participant Flow|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
729996|NCT00126737|P1|Participant Flow|Weight Control Nutritional and Home-based Exercise Program|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises"
729997|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
729998|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
729999|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
730000|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730001|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
730002|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730003|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
730004|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730005|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
730006|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730007|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
730008|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise pr|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730009|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
730010|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730011|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
730012|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730013|NCT00126737|O4|Outcome|Usual Care|Usual care and non-specific health information (C). No intervention.
730014|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730015|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
730016|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730017|NCT00126737|E4|Reported Event|Usual Care|Usual Care and non-specific health information (C). No intervention.
730018|NCT00126737|E3|Reported Event|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730019|NCT00126737|E2|Reported Event|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
730020|NCT00126737|E1|Reported Event|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
730021|NCT00126659|B4|Baseline|Total|Total of all reporting groups
730022|NCT00126659|B3|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
730023|NCT00126659|B2|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
730024|NCT00126659|B1|Baseline|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
730025|NCT00126659|P3|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
730026|NCT00126659|P2|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
730027|NCT00126659|P1|Participant Flow|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
730028|NCT00126659|O3|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
730029|NCT00126659|O2|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
730030|NCT00126659|O1|Outcome|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
730031|NCT00126659|E1|Reported Event|Sorafenib + Cytoreductive Nephrectomy|All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
730032|NCT00126594|B3|Baseline|Total|Total of all reporting groups
730033|NCT00126594|B2|Baseline|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730034|NCT00126594|B1|Baseline|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730035|NCT00126594|P2|Participant Flow|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730036|NCT00126594|P1|Participant Flow|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730037|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730038|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730039|NCT00126594|O1|Outcome|Sorafenib Tosylate or Sorafenib Plus Interferon|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28 and Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730040|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730041|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730042|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730043|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730149|NCT00126126|P2|Participant Flow|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
730044|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730045|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730046|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730047|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730048|NCT00126594|E2|Reported Event|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
730049|NCT00126594|E1|Reported Event|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
730050|NCT00126581|B3|Baseline|Total|Total of all reporting groups
730051|NCT00126581|B2|Baseline|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730052|NCT00126581|B1|Baseline|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730053|NCT00126581|P2|Participant Flow|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730054|NCT00126581|P1|Participant Flow|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730055|NCT00126581|O2|Outcome|Wild Type|
730056|NCT00126581|O1|Outcome|Mutant|
730057|NCT00126581|O2|Outcome|Wild Type|
730058|NCT00126581|O1|Outcome|Mutant|
730059|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730060|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730061|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730062|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730063|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730064|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730065|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730066|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730067|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730068|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730069|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730070|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730071|NCT00126581|E2|Reported Event|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
730072|NCT00126581|E1|Reported Event|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
730073|NCT00126568|B1|Baseline|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
730150|NCT00126126|P1|Participant Flow|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
730074|NCT00126568|P1|Participant Flow|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
730075|NCT00126568|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
730076|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
730077|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
730078|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
730079|NCT00126568|E1|Reported Event|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
730080|NCT00126555|B1|Baseline|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
730081|NCT00126555|P1|Participant Flow|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
730082|NCT00126555|O4|Outcome|Maintenance Phase|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
730083|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
730084|NCT00126555|O2|Outcome|Induction Phase With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
730085|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
730086|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
730087|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
730088|NCT00126555|O4|Outcome|Maintenance|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
730089|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
730090|NCT00126555|O2|Outcome|Induction With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
730091|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
730111|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
730151|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
747656|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
730092|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
730093|NCT00126555|E1|Reported Event|Gefitinib, Radiotherapy, Surgery|"Resectable Strata: Induction Gefitinib (60 days), Surgery followed 3-6 weeks later by daily Radiotherapy 5 days a week for approximately 6-7 weeks then after 4 weeks restart Maintenance Gefitinib for up to additional 12 months post radiation.~Unresectable Strata: Concomitant Radiation/Gefitinib and post-radiation (or post-surgery if surgery is indicated) Gefitinib. Daily Radiotherapy 5 days a week for approximately 6-7 weeks concurrent with Maintenance Gefitinib dose daily up to 12 months.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
730094|NCT00126503|B3|Baseline|Total|Total of all reporting groups
730095|NCT00126503|B2|Baseline|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
730096|NCT00126503|B1|Baseline|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
730097|NCT00126503|P2|Participant Flow|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
730098|NCT00126503|P1|Participant Flow|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
730099|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1. No Phase II patients were in the Phase I cohort.
730100|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. No Phase I patients moved to the Phase II cohort.
730101|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
730102|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
730103|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
730104|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
730105|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
730106|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
730107|NCT00126503|E2|Reported Event|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
730108|NCT00126503|E1|Reported Event|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
730109|NCT00126490|B1|Baseline|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
730110|NCT00126490|P1|Participant Flow|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
730147|NCT00126126|B2|Baseline|Wait List Control Group|Those subjects who were randomized to the wait-list control group.
730148|NCT00126126|B1|Baseline|Intervention|Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program
730112|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
730113|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
730114|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
730115|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
730116|NCT00126490|E1|Reported Event|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
730117|NCT00126438|B3|Baseline|Total|Total of all reporting groups
730118|NCT00126438|B2|Baseline|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
730119|NCT00126438|B1|Baseline|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
730120|NCT00126438|P2|Participant Flow|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
730121|NCT00126438|P1|Participant Flow|AdreView - Heart Failure Group|AdreView (123I-mIBG [meta-iodobenzylguanidine]): 10 milliCurie (mCi) as a single intravenous dose.
730122|NCT00126438|O2|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6).
730123|NCT00126438|O1|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6).
730124|NCT00126438|E2|Reported Event|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
730125|NCT00126438|E1|Reported Event|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
730126|NCT00126425|B3|Baseline|Total|Total of all reporting groups
730127|NCT00126425|B2|Baseline|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at no risk of heart failure.
730128|NCT00126425|B1|Baseline|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at a high risk of heart failure.
730129|NCT00126425|P2|Participant Flow|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
730130|NCT00126425|P1|Participant Flow|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
730131|NCT00126425|O2|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6)
730132|NCT00126425|O1|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6)
730133|NCT00126425|E2|Reported Event|AdreView --Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
730134|NCT00126425|E1|Reported Event|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
730135|NCT00126191|B3|Baseline|Total|Total of all reporting groups
730136|NCT00126191|B2|Baseline|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
730137|NCT00126191|B1|Baseline|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
730138|NCT00126191|P2|Participant Flow|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
730139|NCT00126191|P1|Participant Flow|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
730140|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
730141|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
730142|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
730143|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
730144|NCT00126191|E2|Reported Event|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
730145|NCT00126191|E1|Reported Event|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
730146|NCT00126126|B3|Baseline|Total|Total of all reporting groups
730152|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
730153|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
730154|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
730155|NCT00126126|E2|Reported Event|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
730156|NCT00126126|E1|Reported Event|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
730157|NCT00126113|B3|Baseline|Total|Total of all reporting groups
730158|NCT00126113|B2|Baseline|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
730159|NCT00126113|B1|Baseline|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
730160|NCT00126113|P2|Participant Flow|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
730161|NCT00126113|P1|Participant Flow|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
730162|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
730163|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
730164|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
730165|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
730166|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
730167|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
730168|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
730169|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
730170|NCT00126113|E2|Reported Event|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
730171|NCT00126113|E1|Reported Event|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
730172|NCT00125957|B3|Baseline|Total|Total of all reporting groups
730173|NCT00125957|B2|Baseline|Placebo-Wellbutrin|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to Wellbutrin 100 mg twice daily (BID). At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
730174|NCT00125957|B1|Baseline|Wellbutrin-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg twice daily (BID) of Wellbutrin) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
730175|NCT00125957|P2|Participant Flow|Placebo First, Then Wellbutrin|Subjects randomly assigned to the Placebo first, then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.
730176|NCT00125957|P1|Participant Flow|Wellbutrin First, Then Placebo|Subjects randomly assigned to the Wellbutrin first, then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.
730177|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
730178|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
730179|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
730180|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
730181|NCT00125957|E2|Reported Event|Placebo-Bupropion|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to bupropion 100 mg BID. At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
730182|NCT00125957|E1|Reported Event|Bupropion-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg BID bupropion) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
730183|NCT00125931|B1|Baseline|Open Label|Open label treatment with pentazocine
730185|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
730186|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
730187|NCT00125931|E1|Reported Event|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
730188|NCT00125762|B1|Baseline|Single Arm Undergoing FibroScan|"Single arm active comparison of biopsy to vibration controlled elastography~FibroScan"
730189|NCT00125762|P1|Participant Flow|Active Arm|All patients received a liver biopsy and a FibroScan
730190|NCT00125762|O1|Outcome|Single Arm Undergoing FibroScan|"Single arm active comparison of biopsy to vibration controlled elastography~FibroScan"
730191|NCT00125762|O1|Outcome|Single Arm Undergoing FibroScan|"Single arm active comparison of biopsy to vibration controlled elastography~FibroScan"
730192|NCT00125762|E1|Reported Event|Active Arm|All patients received a liver biopsy and a FibroScan
730193|NCT00125658|B3|Baseline|Total|Total of all reporting groups
730194|NCT00125658|B2|Baseline|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730195|NCT00125658|B1|Baseline|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730196|NCT00125658|P2|Participant Flow|Order B (Power Prior to FTP)|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
730197|NCT00125658|P1|Participant Flow|Order A (FTP Prior to Power)|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
730198|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730199|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730200|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730201|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730202|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730203|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730204|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730205|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730206|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730207|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730208|NCT00125658|O2|Outcome|Order B|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
730209|NCT00125658|O1|Outcome|Order A|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
730210|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730211|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730212|NCT00125658|E2|Reported Event|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
730213|NCT00125658|E1|Reported Event|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
730214|NCT00125619|B3|Baseline|Total|Total of all reporting groups
730215|NCT00125619|B2|Baseline|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730216|NCT00125619|B1|Baseline|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730217|NCT00125619|P2|Participant Flow|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730218|NCT00125619|P1|Participant Flow|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730219|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730220|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730221|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730222|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730223|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730224|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730225|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730226|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730227|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730228|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730229|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730230|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730231|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730232|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730233|NCT00125619|E2|Reported Event|Arm 1|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
730234|NCT00125619|E1|Reported Event|ARM2|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
730235|NCT00125593|B3|Baseline|Total|Total of all reporting groups
730236|NCT00125593|B2|Baseline|Placebo|Once daily tablet
730237|NCT00125593|B1|Baseline|Simvastatin Plus Ezetimibe|Once daily tablet
730238|NCT00125593|P2|Participant Flow|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730239|NCT00125593|P1|Participant Flow|Simvastatin 20mg Plus Ezetimibe 10mg|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730240|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730241|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730242|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730243|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730244|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730245|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730289|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
730833|NCT00123955|O1|Outcome|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
730246|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730247|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730248|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730249|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730250|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730251|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730252|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
730253|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
730254|NCT00125593|E2|Reported Event|Placebo|Once daily tablet
730255|NCT00125593|E1|Reported Event|Simvastatin Plus Ezetimibe|Once daily tablet
730256|NCT00125528|B3|Baseline|Total|Total of all reporting groups
730257|NCT00125528|B2|Baseline|Placebo|placebo: placebo bid
730258|NCT00125528|B1|Baseline|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
730259|NCT00125528|P2|Participant Flow|Placebo|placebo: placebo bid
730260|NCT00125528|P1|Participant Flow|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
730261|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
730262|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
730263|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
730264|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
730265|NCT00125528|E2|Reported Event|Placebo|placebo: placebo bid
730266|NCT00125528|E1|Reported Event|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
730267|NCT00125515|B4|Baseline|Total|Total of all reporting groups
730268|NCT00125515|B3|Baseline|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
730269|NCT00125515|B2|Baseline|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
730270|NCT00125515|B1|Baseline|Placebo|Placebo plus oral naltrexone
730271|NCT00125515|P3|Participant Flow|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
730272|NCT00125515|P2|Participant Flow|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
730273|NCT00125515|P1|Participant Flow|Placebo|Placebo plus oral naltrexone
730274|NCT00125515|O3|Outcome|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
730275|NCT00125515|O2|Outcome|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
730276|NCT00125515|O1|Outcome|Placebo|Placebo plus oral naltrexone
730277|NCT00125515|E3|Reported Event|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
730278|NCT00125515|E2|Reported Event|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
730279|NCT00125515|E1|Reported Event|Placebo|Placebo plus oral naltrexone
730280|NCT00125268|B3|Baseline|Total|Total of all reporting groups
730281|NCT00125268|B2|Baseline|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
730282|NCT00125268|B1|Baseline|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
730283|NCT00125268|P2|Participant Flow|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
730284|NCT00125268|P1|Participant Flow|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
730285|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
730286|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
730287|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
730288|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
747657|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
730290|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
730291|NCT00125268|E2|Reported Event|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
730292|NCT00125268|E1|Reported Event|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
730293|NCT00125242|B3|Baseline|Total|Total of all reporting groups
730294|NCT00125242|B2|Baseline|Non Treatment Stimuli Development Participants|Participants for stimuli development provided normative data for stimuli development. e.g., Treatment items were grouped according to typicality of category membership (apple - typical fruit; coconut - atypical fruit). These participants provided the reponses that served as the basis for classifying/organizing stimuli. Because data from this group were used only for the purposes of stimuli development, no findings are reported for this group. See Cameron, R.M., Wambaugh, J.L., & Mauszycki, S. (2008). Effects of age, gender and education on semantic fluency for living and artifact categories. Aphasiology, 22(7/8), 790-801, doi: 10.1080/02687030701818018 for related findings.
730295|NCT00125242|B1|Baseline|SFA Treatment Participants|Semantic Feature Analysis (SFA) is a word-retrieval treatment for aphasia. SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, associated actions). For some participants, treatment items were grouped by typicality of category membership (e.g, robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in single-subject, multiple baseline designs. Thus, replication of treatment effects could be evaluated within and across participants. Treatment was administered by SLPs three times per week until prescribed accuracy levels were met during probes or a maximum number of treatment sessions was completed.
730296|NCT00125242|P2|Participant Flow|SFA Treatment Participants|Stroke survivors who received experimental therapy
730297|NCT00125242|P1|Participant Flow|Non Treatment Stimuli Development Participants|Non-brain-injured participants who were enrolled for the purpose of stimuli development
730298|NCT00125242|O1|Outcome|SFA Treatment Participants|Stroke survivors received Semantic Feature Analysis for the treatment of word-retrieval deficits. Each SFA treatment participant received word-retrieval therapy applied sequentially to experimental lists of items. Effect sizes were calculated for each participant for each list. An average effect size was calculated for each participant and an overall average was determined for all participants as a group.
730299|NCT00125242|E2|Reported Event|NonTreatment Stimuli Development Participants|Non-brain-injured participants who were utilized to develop treatment stimuli.
730300|NCT00125242|E1|Reported Event|SFA Treatment Participants|"Stroke-survivors who received Semantic Feature Analysis therapy for aphasic word-retrieval deficits~Semantic Feature Training: The treatment is designed to stimulate the semantic feature network so that it may serve as not only a mechanism for improving disrupted lexical semantic processing, but also as a compensatory strategy during word retrieval failures."
730301|NCT00125190|B1|Baseline|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730302|NCT00125190|P1|Participant Flow|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730303|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730304|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730305|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730306|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730307|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730308|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730309|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730310|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730311|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730312|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730444|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730313|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730314|NCT00125190|E1|Reported Event|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
730315|NCT00125164|B5|Baseline|Total|Total of all reporting groups
730316|NCT00125164|B4|Baseline|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730317|NCT00125164|B3|Baseline|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730318|NCT00125164|B2|Baseline|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730319|NCT00125164|B1|Baseline|Untreated|Observational Group
730320|NCT00125164|P4|Participant Flow|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730321|NCT00125164|P3|Participant Flow|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730322|NCT00125164|P2|Participant Flow|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730323|NCT00125164|P1|Participant Flow|Untreated|Observational Group
730324|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730325|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730326|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730327|NCT00125164|O1|Outcome|Untreated|Observational Group
730328|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730329|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730330|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730331|NCT00125164|O1|Outcome|Untreated|Observational Group
730332|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730333|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730334|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730335|NCT00125164|O1|Outcome|Untreated|Observational Group
730336|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730337|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730338|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730339|NCT00125164|O1|Outcome|Untreated|Observational Group
730340|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730341|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730342|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730343|NCT00125164|O1|Outcome|Untreated|Observational Group
730344|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730345|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730346|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730347|NCT00125164|O1|Outcome|Untreated|Observational Group
730348|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730349|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730350|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730351|NCT00125164|O1|Outcome|Untreated|Observational Group
730352|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730353|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730663|NCT00124709|B1|Baseline|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730354|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730355|NCT00125164|O1|Outcome|Untreated|Observational Group
730356|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730357|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730358|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730359|NCT00125164|O1|Outcome|Untreated|Observational Group
730360|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730361|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730362|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730363|NCT00125164|O1|Outcome|Untreated|Observational Group
730364|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730365|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730366|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730367|NCT00125164|O1|Outcome|Untreated|Observational Group
730368|NCT00125164|E4|Reported Event|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
730369|NCT00125164|E3|Reported Event|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
730370|NCT00125164|E2|Reported Event|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
730371|NCT00125164|E1|Reported Event|Untreated|Observational Group
730372|NCT00125138|B5|Baseline|Total|Total of all reporting groups
730373|NCT00125138|B4|Baseline|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
730374|NCT00125138|B3|Baseline|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
730375|NCT00125138|B2|Baseline|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
730376|NCT00125138|B1|Baseline|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
730377|NCT00125138|P4|Participant Flow|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
730378|NCT00125138|P3|Participant Flow|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
730379|NCT00125138|P2|Participant Flow|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
730380|NCT00125138|P1|Participant Flow|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
730381|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
730382|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
730383|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
730384|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
730385|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
730386|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
730387|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
730388|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
730389|NCT00125138|E4|Reported Event|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
730390|NCT00125138|E3|Reported Event|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
730391|NCT00125138|E2|Reported Event|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
730392|NCT00125138|E1|Reported Event|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
730393|NCT00125034|B3|Baseline|Total|Total of all reporting groups
730394|NCT00125034|B2|Baseline|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730395|NCT00125034|B1|Baseline|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730396|NCT00125034|P2|Participant Flow|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730445|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730397|NCT00125034|P1|Participant Flow|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730398|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730399|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730400|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730401|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730402|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730403|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730404|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730405|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730406|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730407|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730408|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730409|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730410|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730411|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730412|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730413|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730414|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730415|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730416|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730417|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730418|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730419|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730420|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730421|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730422|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730446|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730423|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730424|NCT00125034|E2|Reported Event|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730425|NCT00125034|E1|Reported Event|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
730426|NCT00124982|B3|Baseline|Total|Total of all reporting groups
730427|NCT00124982|B2|Baseline|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730428|NCT00124982|B1|Baseline|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730429|NCT00124982|P3|Participant Flow|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730430|NCT00124982|P2|Participant Flow|ST-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730431|NCT00124982|P1|Participant Flow|Short Term (ST) Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730432|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730433|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730434|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730435|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730436|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730437|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730438|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730439|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730440|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730441|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730442|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730443|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730661|NCT00124709|B3|Baseline|Total|Total of all reporting groups
730447|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730448|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730449|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730450|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730451|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730452|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730453|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730454|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730455|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730456|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730457|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730458|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730459|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730460|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730461|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730462|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730463|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730464|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730465|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730466|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730467|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730468|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730469|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730470|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730471|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730472|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730473|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730474|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
730662|NCT00124709|B2|Baseline|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
747658|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
730475|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730476|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730477|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730478|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730479|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730480|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730481|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730482|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730483|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730484|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730485|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730486|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730487|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730488|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730489|NCT00124982|O1|Outcome|All Treated Participants|Open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730834|NCT00123955|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
730490|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730491|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730492|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730493|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730494|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730495|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730496|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730497|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730498|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730499|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730500|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730501|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730502|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730503|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730504|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730505|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
730506|NCT00124982|E2|Reported Event|Abatacept (ST)|
730507|NCT00124982|E1|Reported Event|Abatacept (LT)|
730508|NCT00124943|B5|Baseline|Total|Total of all reporting groups
730509|NCT00124943|B4|Baseline|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730510|NCT00124943|B3|Baseline|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730511|NCT00124943|B2|Baseline|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730512|NCT00124943|B1|Baseline|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730513|NCT00124943|P4|Participant Flow|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730514|NCT00124943|P3|Participant Flow|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730515|NCT00124943|P2|Participant Flow|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730516|NCT00124943|P1|Participant Flow|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730517|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730518|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730519|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730520|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730521|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730522|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730523|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730524|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730525|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730526|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730527|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730528|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730529|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730530|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730531|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730532|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730533|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730534|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730535|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730536|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730537|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730538|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730539|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730540|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730541|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730542|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730543|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730544|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730545|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730546|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730547|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730548|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730549|NCT00124943|E4|Reported Event|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730550|NCT00124943|E3|Reported Event|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730901|NCT00123630|B3|Baseline|Total|Total of all reporting groups
730551|NCT00124943|E2|Reported Event|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
730552|NCT00124943|E1|Reported Event|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
730553|NCT00124748|B3|Baseline|Total|Total of all reporting groups
730554|NCT00124748|B2|Baseline|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730555|NCT00124748|B1|Baseline|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730556|NCT00124748|P2|Participant Flow|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730557|NCT00124748|P1|Participant Flow|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730558|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730559|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730560|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730561|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730562|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730563|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730564|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730565|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730566|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730567|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730568|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730569|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730570|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730571|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730572|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730573|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730574|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730575|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730576|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730577|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730578|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730579|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730580|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730581|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730582|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730583|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730584|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730585|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730586|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730587|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730588|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730589|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730590|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730591|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730592|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730593|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730594|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730595|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730596|NCT00124748|E2|Reported Event|Imatinib 800mg|Patients randomized to receive 800 mg imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
730597|NCT00124748|E1|Reported Event|Imatinib 400mg|Oral dose of 400mg imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
730598|NCT00124735|B11|Baseline|Total|Total of all reporting groups
730664|NCT00124709|P2|Participant Flow|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
730599|NCT00124735|B10|Baseline|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730600|NCT00124735|B9|Baseline|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730601|NCT00124735|B8|Baseline|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730602|NCT00124735|B7|Baseline|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730603|NCT00124735|B6|Baseline|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730604|NCT00124735|B5|Baseline|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730605|NCT00124735|B4|Baseline|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730606|NCT00124735|B3|Baseline|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730607|NCT00124735|B2|Baseline|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730608|NCT00124735|B1|Baseline|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730609|NCT00124735|P10|Participant Flow|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730610|NCT00124735|P9|Participant Flow|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730611|NCT00124735|P8|Participant Flow|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730612|NCT00124735|P7|Participant Flow|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730613|NCT00124735|P6|Participant Flow|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730614|NCT00124735|P5|Participant Flow|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730615|NCT00124735|P4|Participant Flow|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730616|NCT00124735|P3|Participant Flow|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730617|NCT00124735|P2|Participant Flow|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730618|NCT00124735|P1|Participant Flow|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730619|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730620|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730621|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730622|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730623|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730624|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730625|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730626|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730627|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730628|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730629|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730630|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730631|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730632|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730633|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730634|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730635|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730636|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730637|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730638|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730639|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730640|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730641|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730642|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730643|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730644|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730645|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730646|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730647|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730648|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730649|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730650|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730651|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730652|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730653|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
730654|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730655|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730656|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730657|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730658|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
730659|NCT00124735|E2|Reported Event|Rocuronium Continuous Infusion Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)
730660|NCT00124735|E1|Reported Event|Rocuronium Bolus Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).
730665|NCT00124709|P1|Participant Flow|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730666|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
730667|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730668|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
730669|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730670|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
730671|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730672|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
730673|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730674|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
730675|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730676|NCT00124709|E2|Reported Event|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
730677|NCT00124709|E1|Reported Event|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
730678|NCT00124657|B4|Baseline|Total|Total of all reporting groups
730679|NCT00124657|B3|Baseline|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
730680|NCT00124657|B2|Baseline|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
730681|NCT00124657|B1|Baseline|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
730682|NCT00124657|P3|Participant Flow|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
730683|NCT00124657|P2|Participant Flow|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
730684|NCT00124657|P1|Participant Flow|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
730685|NCT00124657|O2|Outcome|Grade 4 Toxicity|Grade 4 toxicity per CTCAE 3.0.
730686|NCT00124657|O1|Outcome|Grade 3 Toxicity|Grade 3 toxicity per CTCAE 3.0.
730687|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
730688|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride.~Erlotinib hydrochloride: This study had 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib was given at the MTD during and after RT for 2 years."
730689|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
730690|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
730691|NCT00124657|O4|Outcome|Phase II GBM|Participants with a diagnosis of intracranial glioblastoma multiforme (GBM) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
730692|NCT00124657|O3|Outcome|Phase II AA|Participants with a diagnosis of intracranial anaplastic astrocytoma (AA) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
730693|NCT00124657|O2|Outcome|Phase I GBM|All participants with a diagnosis of glioblastoma multiforme (GBM) and treated on Phase I.
730694|NCT00124657|O1|Outcome|Phase I AA|All participants with a diagnosis of anaplastic astrocytoma (AA) and treated on Phase I.
730695|NCT00124657|O1|Outcome|Phase I|22 participants were analyzed for MLT over 4 dose levels.
730696|NCT00124657|O1|Outcome|Phase I|Phase I participants
730697|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
730698|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
730699|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
730700|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
730701|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
730702|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
730703|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
730704|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
730705|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
730706|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
730707|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
730708|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
730709|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
730710|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
730711|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
730712|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
730713|NCT00124657|E5|Reported Event|Phase II|Phase II participants received 120 mg/m^2.
730714|NCT00124657|E4|Reported Event|160 mg/m^2 (Phase I)|Participants received dose of 160 mg/m^2, range of actual dose was 151.5-167 mg/m^2.
730715|NCT00124657|E3|Reported Event|120 mg/m^2 (Phase I)|Participants received dose of 120 mg/m^2, range of actual dose was 107-128 mg/m^2.
730716|NCT00124657|E2|Reported Event|90 mg/m^2 (Phase I)|Participants received dose of 90 mg/m^2, range of actual dose was 85-87.5 mg/m^2.
730717|NCT00124657|E1|Reported Event|70 mg/m^2 (Phase I)|Participants received dose of 70 mg/m^2, range of actual dose was 68-83 mg/m^2.
730718|NCT00124618|B1|Baseline|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
730719|NCT00124618|P1|Participant Flow|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
730720|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
730721|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
730722|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
730723|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
730724|NCT00124618|E1|Reported Event|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
730725|NCT00124579|B1|Baseline|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
730726|NCT00124579|P1|Participant Flow|Bortezomib With Thalidomide and Dexamethasone Induction|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
730727|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
730728|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
730729|NCT00124579|O1|Outcome|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
730730|NCT00124579|E1|Reported Event|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
730731|NCT00124462|B3|Baseline|Total|Total of all reporting groups
730732|NCT00124462|B2|Baseline|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.~Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
730733|NCT00124462|B1|Baseline|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
730734|NCT00124462|P2|Participant Flow|Placebo to Realignment|"Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.~Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear."
730735|NCT00124462|P1|Participant Flow|Realignment to Placebo|"Realignment/Experimental Knee Brace and Shoe Insert- A valgus brace, customized functional orthodic for neutral foot position and motion control footwear.~Placebo/Control Knee brace and Shoe Insert- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole"
730736|NCT00124462|O2|Outcome|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.~Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
730737|NCT00124462|O1|Outcome|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
730786|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730738|NCT00124462|O2|Outcome|Placebo to Realignment|"Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole.~Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
730739|NCT00124462|O1|Outcome|Realignment to Placebo|Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear Non realigning knee brace and flat orthodic: A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
730740|NCT00124462|E2|Reported Event|Placebo to Realignment|Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
730741|NCT00124462|E1|Reported Event|Realignment to Placebo|"Realigning knee brace and custom orthodic- A valgus brace, customized functional orthotic for neutral foot position and motion control footwear.~Realigning knee brace and custom orthodic: A valgus brace, customized functional orthotic for neutral foot position and motion control footwear"
730742|NCT00124449|B3|Baseline|Total|Total of all reporting groups
730743|NCT00124449|B2|Baseline|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730744|NCT00124449|B1|Baseline|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730745|NCT00124449|P2|Participant Flow|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730746|NCT00124449|P1|Participant Flow|Abatacept|Abatacept by intravenous (IV) infusion, dose based on participant’s body weight at the screening visit
730747|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730748|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730749|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730750|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730751|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730752|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730753|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730754|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730755|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730756|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730757|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
730758|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730759|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
730760|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730761|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730762|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730763|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730764|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730765|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730766|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730767|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730768|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730769|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
730770|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730771|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730772|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730773|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
730774|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
730775|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
730776|NCT00124449|E2|Reported Event|Placebo|
730777|NCT00124449|E1|Reported Event|BMS-188667|
730778|NCT00124176|B3|Baseline|Total|Total of all reporting groups
730779|NCT00124176|B2|Baseline|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730780|NCT00124176|B1|Baseline|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730781|NCT00124176|P2|Participant Flow|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730782|NCT00124176|P1|Participant Flow|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730783|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730784|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730785|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730787|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730788|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730789|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730790|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730791|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730792|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730793|NCT00124176|E2|Reported Event|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
730794|NCT00124176|E1|Reported Event|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
730795|NCT00124072|B5|Baseline|Total|Total of all reporting groups
730796|NCT00124072|B4|Baseline|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
730797|NCT00124072|B3|Baseline|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
730798|NCT00124072|B2|Baseline|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
730799|NCT00124072|B1|Baseline|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
730800|NCT00124072|P4|Participant Flow|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
730801|NCT00124072|P3|Participant Flow|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
730802|NCT00124072|P2|Participant Flow|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
730803|NCT00124072|P1|Participant Flow|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
730804|NCT00124072|O4|Outcome|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
730805|NCT00124072|O3|Outcome|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
730806|NCT00124072|O2|Outcome|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
730807|NCT00124072|O1|Outcome|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
730808|NCT00124072|E4|Reported Event|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
730809|NCT00124072|E3|Reported Event|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
730810|NCT00124072|E2|Reported Event|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
730811|NCT00124072|E1|Reported Event|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
730812|NCT00124020|B3|Baseline|Total|Total of all reporting groups
730813|NCT00124020|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
730814|NCT00124020|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
730815|NCT00124020|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
730816|NCT00124020|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
730817|NCT00124020|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
730818|NCT00124020|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
730819|NCT00124020|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
730820|NCT00124020|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
730821|NCT00123955|B3|Baseline|Total|Total of all reporting groups
730822|NCT00123955|B2|Baseline|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
730823|NCT00123955|B1|Baseline|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
730824|NCT00123955|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
730825|NCT00123955|P1|Participant Flow|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
730826|NCT00123955|O2|Outcome|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
730835|NCT00123955|E1|Reported Event|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
730836|NCT00123734|B1|Baseline|Group 1|
730837|NCT00123734|P1|Participant Flow|Group 1|
730838|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
730839|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
730840|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
730841|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
730842|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
730843|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
730844|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
730845|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
730846|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
730847|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
730848|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
730849|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
730850|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
730851|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
730852|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
730853|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
730854|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
730855|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
730856|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
730857|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
730858|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
730859|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
730860|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
730861|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
730862|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
730863|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
730864|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
730865|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
730866|NCT00123734|E1|Reported Event|Group 1|
730867|NCT00123682|B5|Baseline|Total|Total of all reporting groups
730868|NCT00123682|B4|Baseline|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
730869|NCT00123682|B3|Baseline|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
730870|NCT00123682|B2|Baseline|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
730871|NCT00123682|B1|Baseline|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
730872|NCT00123682|P4|Participant Flow|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
730873|NCT00123682|P3|Participant Flow|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
730874|NCT00123682|P2|Participant Flow|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
730875|NCT00123682|P1|Participant Flow|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
730876|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
730877|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
730878|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
730879|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
730880|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
730881|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
730882|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
730883|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
730884|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|
730885|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|
730886|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|
730887|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|
730888|NCT00123682|E4|Reported Event|Reactive Referral and Self-help Materials|
730889|NCT00123682|E3|Reported Event|Proactive Referral and Self-help Materials|
730890|NCT00123682|E2|Reported Event|Reactive Referral and Intensive Counseling|
730891|NCT00123682|E1|Reported Event|Proactive Referral and Intensive Telephone Counseling|
730892|NCT00123643|B3|Baseline|Total|Total of all reporting groups
730893|NCT00123643|B2|Baseline|Glyburide|
730894|NCT00123643|B1|Baseline|Rosiglitazone|
730895|NCT00123643|P2|Participant Flow|Glyburide|
730896|NCT00123643|P1|Participant Flow|Rosiglitazone|
730897|NCT00123643|O2|Outcome|Glyburide|
730898|NCT00123643|O1|Outcome|Rosiglitazone|
730899|NCT00123643|E2|Reported Event|Glyburide|
730900|NCT00123643|E1|Reported Event|Rosiglitazone|
730902|NCT00123630|B2|Baseline|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730903|NCT00123630|B1|Baseline|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730904|NCT00123630|P2|Participant Flow|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730905|NCT00123630|P1|Participant Flow|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730906|NCT00123630|O2|Outcome|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730907|NCT00123630|O1|Outcome|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730908|NCT00123630|E2|Reported Event|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730909|NCT00123630|E1|Reported Event|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
730910|NCT00123604|B3|Baseline|Total|Total of all reporting groups
730911|NCT00123604|B2|Baseline|Carvedilol|Carvedilol, orally, 25mg, twice daily for five months
730912|NCT00123604|B1|Baseline|Metoprolol|Metoprolol, orally, 200mg, twice daily for five months
730913|NCT00123604|P2|Participant Flow|Carvedilol|Carvedilol, orally, 25 mg, once daily
730914|NCT00123604|P1|Participant Flow|Metoprolol|Metoprolol, orally, 200 mg, once daily
730915|NCT00123604|O2|Outcome|Metoprolol|Metoprolol, orally, 200mg, once daily
730916|NCT00123604|O1|Outcome|Carvedilol|Carvedilol, orally, 25mg, once daily
730917|NCT00123604|E2|Reported Event|Carvedilol|Carvedilol, orally, 25 mg, once daily
730918|NCT00123604|E1|Reported Event|Metoprolol|Metoprolol, orally, 200mg, once daily
730919|NCT00123487|B3|Baseline|Total|Total of all reporting groups
730920|NCT00123487|B2|Baseline|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730921|NCT00123487|B1|Baseline|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730922|NCT00123487|P2|Participant Flow|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730923|NCT00123487|P1|Participant Flow|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730924|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730925|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730926|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730927|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730928|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730929|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730930|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730931|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730932|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
747659|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
730933|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730934|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730935|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730936|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730937|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730938|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730939|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730940|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730941|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730942|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730943|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730944|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730945|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730946|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730947|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730948|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730949|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730950|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730951|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730952|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730953|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730954|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730955|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730956|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
730957|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730958|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
731113|NCT00123123|E1|Reported Event|Placebo|Vehicle control twice a day (oral rinse)
731114|NCT00122980|B3|Baseline|Total|Total of all reporting groups
730959|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730960|NCT00123487|E2|Reported Event|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730961|NCT00123487|E1|Reported Event|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
730962|NCT00123474|B5|Baseline|Total|Total of all reporting groups
730963|NCT00123474|B4|Baseline|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730964|NCT00123474|B3|Baseline|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730965|NCT00123474|B2|Baseline|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730966|NCT00123474|B1|Baseline|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730967|NCT00123474|P4|Participant Flow|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730968|NCT00123474|P3|Participant Flow|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730969|NCT00123474|P2|Participant Flow|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730970|NCT00123474|P1|Participant Flow|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730971|NCT00123474|O3|Outcome|Total|Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730972|NCT00123474|O2|Outcome|Other Treatment Groups|Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
730973|NCT00123474|O1|Outcome|100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730974|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730975|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730976|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730977|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
730978|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730979|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730980|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730981|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
730982|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730983|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731957|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
730984|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
730985|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
730986|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730987|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730988|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730989|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730990|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730991|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730992|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730993|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
730994|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
730995|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
730996|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
730997|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
730998|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
730999|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
731000|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
731001|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731002|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731003|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731004|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731005|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731006|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731007|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731008|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731009|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731057|NCT00123474|E3|Reported Event|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
731010|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731011|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731012|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731013|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731014|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731015|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731016|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731017|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731018|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731019|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731020|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731021|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731022|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731023|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731024|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731025|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731026|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731027|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731028|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731029|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731030|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731031|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731032|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731033|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731034|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731035|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731036|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731037|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731038|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731039|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731040|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731041|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731042|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731043|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731044|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731045|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731046|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731047|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731048|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731049|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731050|NCT00123474|O4|Outcome|Dasatinib 140 mg Total Daily Dose|Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731051|NCT00123474|O3|Outcome|Dasatinib 100 mg Total Daily Dose|Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731052|NCT00123474|O2|Outcome|Dasatinib BID|Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
731053|NCT00123474|O1|Outcome|Dasatinib QD|Participants received either 100 mg QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731054|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731055|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
731056|NCT00123474|E4|Reported Event|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
731058|NCT00123474|E2|Reported Event|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
731059|NCT00123474|E1|Reported Event|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
731060|NCT00123422|B4|Baseline|Total|Total of all reporting groups
731061|NCT00123422|B3|Baseline|Exercise|"Exercise training~Exercise: exercise training"
731062|NCT00123422|B2|Baseline|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
731063|NCT00123422|B1|Baseline|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
731064|NCT00123422|P3|Participant Flow|Exercise|"Exercise training~Exercise: exercise training"
731065|NCT00123422|P2|Participant Flow|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
731066|NCT00123422|P1|Participant Flow|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
731067|NCT00123422|O3|Outcome|Exercise|"Exercise training~Exercise: exercise training"
731068|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
731069|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
731070|NCT00123422|O3|Outcome|Exercise|"Exercise training~Exercise: exercise training"
731071|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
731072|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
731073|NCT00123422|E3|Reported Event|Exercise|"Exercise training~Exercise: exercise training"
731074|NCT00123422|E2|Reported Event|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
731075|NCT00123422|E1|Reported Event|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
731076|NCT00123409|B3|Baseline|Total|Total of all reporting groups
731077|NCT00123409|B2|Baseline|Usual Care|"Usual Care~Usual Care: Usual care"
731078|NCT00123409|B1|Baseline|Telephone Disease Management|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
731079|NCT00123409|P2|Participant Flow|Arm 2|"Usual Care~Usual Care: Usual care"
731080|NCT00123409|P1|Participant Flow|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
731081|NCT00123409|O2|Outcome|Arm 2|"Usual Care~Usual Care: Usual care"
731082|NCT00123409|O1|Outcome|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
731083|NCT00123409|O2|Outcome|Usual Care|"Usual Care~Usual Care: Usual care"
731084|NCT00123409|O1|Outcome|Telephone Based Management|"Telephone Based Management used to reduce alcohol misuse~Telephone disease management: Telephone based care management"
731085|NCT00123409|E2|Reported Event|Arm 2|"Usual Care~Usual Care: Usual care"
731086|NCT00123409|E1|Reported Event|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
731087|NCT00123162|B3|Baseline|Total|Total of all reporting groups
731088|NCT00123162|B2|Baseline|Placebo|A single vaginal dose of placebo.
731089|NCT00123162|B1|Baseline|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
731090|NCT00123162|P2|Participant Flow|Placebo|A single vaginal dose of placebo.
731091|NCT00123162|P1|Participant Flow|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
731092|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
731093|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
731094|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
731095|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
731096|NCT00123162|E2|Reported Event|Placebo|A single vaginal dose of placebo.
731097|NCT00123162|E1|Reported Event|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
731098|NCT00123123|B4|Baseline|Total|Total of all reporting groups
731099|NCT00123123|B3|Baseline|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
731100|NCT00123123|B2|Baseline|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
731101|NCT00123123|B1|Baseline|Placebo|Vehicle control twice a day (oral rinse)
731102|NCT00123123|P3|Participant Flow|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
731103|NCT00123123|P2|Participant Flow|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
731104|NCT00123123|P1|Participant Flow|Placebo|Vehicle control twice a day (oral rinse)
731105|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
731106|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
731107|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
731108|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
731109|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
731110|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
731111|NCT00123123|E3|Reported Event|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
731112|NCT00123123|E2|Reported Event|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
731115|NCT00122980|B2|Baseline|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
731116|NCT00122980|B1|Baseline|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
731117|NCT00122980|P2|Participant Flow|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
731118|NCT00122980|P1|Participant Flow|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
731119|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731120|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731121|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731122|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731123|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731124|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731125|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731126|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731127|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731128|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731129|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731130|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731131|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731132|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731133|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731134|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731135|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731136|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731137|NCT00122980|E2|Reported Event|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
731138|NCT00122980|E1|Reported Event|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
731139|NCT00122954|B3|Baseline|Total|Total of all reporting groups
731140|NCT00122954|B2|Baseline|Fish Oil Concentrate|Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA)
731141|NCT00122954|B1|Baseline|Placebo|Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams.
731142|NCT00122954|P2|Participant Flow|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
731143|NCT00122954|P1|Participant Flow|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
731144|NCT00122954|O2|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
731145|NCT00122954|O1|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
731146|NCT00122954|O2|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
731958|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
731147|NCT00122954|O1|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
731148|NCT00122954|E2|Reported Event|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
731149|NCT00122954|E1|Reported Event|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
731150|NCT00122681|B3|Baseline|Total|Total of all reporting groups
731151|NCT00122681|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731152|NCT00122681|B1|Baseline|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731153|NCT00122681|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731154|NCT00122681|P1|Participant Flow|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731155|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 12-Month persistent infection with HPV-18.
731156|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 12-Month persistent infection with HPV-18.
731157|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 12-Month persistent infection with HPV-18.
731158|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 12-Month persistent infection with HPV-18.
731159|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-18.
731160|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-18.
731161|NCT00122681|O2|Outcome|Cervarix Group With HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-18.
731162|NCT00122681|O1|Outcome|Cervarix Group Without HPV-18 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-18.
731163|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, with 12 Month persistent infection with HPV-16.
731164|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, without 12 Month persistent infection with HPV-16.
731165|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, with 12 Month persistent infection with HPV-16.
731166|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 12-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, without 12 Month persistent infection with HPV-16.
731167|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-16.
731168|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-16.
731169|NCT00122681|O2|Outcome|Cervarix Group With HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-16.
731170|NCT00122681|O1|Outcome|Cervarix Group Without HPV-16 6-Month Persistent Infection|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-16.
731171|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731172|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731173|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731174|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731175|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731176|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731177|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731178|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731179|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731180|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731181|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731182|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731183|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731184|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731185|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731186|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731187|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731188|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731189|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731190|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731191|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731192|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731193|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731194|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731195|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731196|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731197|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731198|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731199|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731200|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731201|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731202|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731203|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731204|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731205|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731206|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731207|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731208|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731209|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731210|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731211|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731212|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731213|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731214|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731215|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731216|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731217|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731218|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731959|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731219|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731220|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731221|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731222|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731223|NCT00122681|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
731224|NCT00122681|E1|Reported Event|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
731225|NCT00122460|B3|Baseline|Total|Total of all reporting groups
731226|NCT00122460|B2|Baseline|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731227|NCT00122460|B1|Baseline|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731228|NCT00122460|P2|Participant Flow|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731229|NCT00122460|P1|Participant Flow|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731230|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731231|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731232|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731233|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731234|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731235|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731236|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731237|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731238|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731239|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731240|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731436|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
731241|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731242|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731243|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731244|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731245|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731246|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731247|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731248|NCT00122460|E2|Reported Event|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731249|NCT00122460|E1|Reported Event|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
731250|NCT00122447|B5|Baseline|Total|Total of all reporting groups
731251|NCT00122447|B4|Baseline|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
731252|NCT00122447|B3|Baseline|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
731253|NCT00122447|B2|Baseline|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
731254|NCT00122447|B1|Baseline|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
731255|NCT00122447|P4|Participant Flow|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
731256|NCT00122447|P3|Participant Flow|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
731257|NCT00122447|P2|Participant Flow|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
731258|NCT00122447|P1|Participant Flow|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
731259|NCT00122447|O3|Outcome|Diabetes|"After 75g OGTT:~Fasting glucose >=126 mg/dl and 2-hr glucose level >=200 mg/dl"
731260|NCT00122447|O2|Outcome|Impaired Glucose Tolerance (IGT)|"After 75g OGTT:~Fasting glucose <126 mg/dl and 2-hr glucose level 140-199 mg/dl"
731261|NCT00122447|O1|Outcome|Normal Glucose Tolerance (NGT)|Normal fasting glucose (<100 mg/dl) and normal 2-hr glucose level (<140 mg/dl) after 75g OGTT
731262|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
731263|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
731264|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
731265|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
731266|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
731267|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
731268|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
731269|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
731270|NCT00122447|E5|Reported Event|Enrolled, But Not Yet Randomized|Enrolled into study, but not yet randomized to study medication
731271|NCT00122447|E4|Reported Event|Placebo|Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day
731272|NCT00122447|E3|Reported Event|Alpha Lipoic Acid|Antioxidant
731273|NCT00122447|E2|Reported Event|Olmesartan|Angiotensin receptor blocker (ARB)
731274|NCT00122447|E1|Reported Event|Aspirin|Anti-inflammatory agent
731275|NCT00122382|B3|Baseline|Total|Total of all reporting groups
731276|NCT00122382|B2|Baseline|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731847|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731277|NCT00122382|B1|Baseline|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731278|NCT00122382|P3|Participant Flow|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with weekly oral MTX were administered every 28 days from Month 12 to Month 24 (open-label period).
731279|NCT00122382|P2|Participant Flow|Placebo (PLA) + Methotrexate (MTX) (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX) titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12 (end of double blind period).
731280|NCT00122382|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12 (end of double blind period).
731281|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731282|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731283|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731284|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731285|NCT00122382|O2|Outcome|Year 2 Change|Year 2 Change = Day 729 (Month 24) - Day 365 (Month 12)
731286|NCT00122382|O1|Outcome|Year 1 Change|Year 1 Change = Day 365 - Day 1
731287|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731288|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731289|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
731290|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
731291|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731292|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731293|NCT00122382|O1|Outcome|ABA + MTX (Open-label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731294|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731295|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731437|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
731296|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731297|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731298|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731299|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731300|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731301|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
731302|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
731303|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
731304|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
731305|NCT00122382|O2|Outcome|Anti-CTLA4-T Antibody Response|
731306|NCT00122382|O1|Outcome|Anti-Abatacept Antibody Response|
731307|NCT00122382|O1|Outcome|ABA + MTX (Open Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731308|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
731309|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731310|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731311|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731312|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731313|NCT00122382|O2|Outcome|ABA + MTX Post-discontinuation|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
747660|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
731314|NCT00122382|O1|Outcome|ABA+ MTX On-treatment|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731315|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731316|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731317|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731318|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731319|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731320|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731321|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731322|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731323|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731324|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731325|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731326|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731327|NCT00122382|E2|Reported Event|Placebo|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
731328|NCT00122382|E1|Reported Event|Abatacept|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
731329|NCT00122369|B4|Baseline|Total|Total of all reporting groups
731330|NCT00122369|B3|Baseline|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
731331|NCT00122369|B2|Baseline|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731332|NCT00122369|B1|Baseline|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731333|NCT00122369|P3|Participant Flow|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731334|NCT00122369|P2|Participant Flow|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731335|NCT00122369|P1|Participant Flow|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731336|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731337|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731338|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731339|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731340|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731341|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731342|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731343|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731344|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731345|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731346|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731347|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731348|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731349|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731350|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731351|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731352|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731353|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731354|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731355|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731356|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731357|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731358|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731359|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731360|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731361|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731362|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731363|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731364|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731365|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731366|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731367|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731368|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731369|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731370|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731371|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731372|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731373|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731374|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731375|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731376|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731377|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731378|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731379|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731380|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731381|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731382|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731383|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731384|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731385|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731386|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731387|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731388|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731389|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731390|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731391|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731392|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731393|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731394|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731395|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731396|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731397|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731398|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731399|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731400|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731401|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731402|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731403|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731404|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731405|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731438|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
731406|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731407|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731408|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731409|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731410|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731411|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731412|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731413|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731414|NCT00122369|O3|Outcome|Uncertain Diagnosis|"were in the uncertain diagnostic group, either because their result had not been communicated yet (n=54); their LCBB could not be performed for technical reasons and they were waiting for a surgical excision (n=14); or histology showed at risk lesions (n=4) or benign cells with surgery recommended for excision and final diagnosis (n=1)."
731415|NCT00122369|O2|Outcome|Known Malignant Disease|Women who were diagnosed to have malignant disease
731416|NCT00122369|O1|Outcome|Known Benign Disease|Women who were diagnosed to have benign disease
731417|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
731418|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731419|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731420|NCT00122369|E3|Reported Event|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
731421|NCT00122369|E2|Reported Event|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
731422|NCT00122369|E1|Reported Event|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
731423|NCT00122317|B1|Baseline|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
731424|NCT00122317|P1|Participant Flow|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
731425|NCT00122317|O1|Outcome|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
731426|NCT00122317|O1|Outcome|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
731427|NCT00122317|O1|Outcome|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
731428|NCT00122317|O1|Outcome|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
731429|NCT00122317|E1|Reported Event|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
731430|NCT00122187|B3|Baseline|Total|Total of all reporting groups
731431|NCT00122187|B2|Baseline|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
731432|NCT00122187|B1|Baseline|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
731433|NCT00122187|P2|Participant Flow|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
731434|NCT00122187|P1|Participant Flow|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
731435|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
731960|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
731439|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
731440|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
731441|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
731442|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
731443|NCT00122187|E2|Reported Event|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
731444|NCT00122187|E1|Reported Event|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
731445|NCT00122135|B3|Baseline|Total|Total of all reporting groups
731446|NCT00122135|B2|Baseline|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
731447|NCT00122135|B1|Baseline|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
731448|NCT00122135|P2|Participant Flow|Patients Without VI|Patients who did not receive the Values Inventory prior to their clinic visit
731449|NCT00122135|P1|Participant Flow|Patients With VI|"patients / surrogates who did receive the Values Inventory prior to their clinic appointment~Values history discussion w/physician & patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
731450|NCT00122135|O2|Outcome|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
731451|NCT00122135|O1|Outcome|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
731452|NCT00122135|E2|Reported Event|Patients Without VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
731453|NCT00122135|E1|Reported Event|Patients With VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
731454|NCT00122109|B3|Baseline|Total|Total of all reporting groups
731455|NCT00122109|B2|Baseline|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferncing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
731456|NCT00122109|B1|Baseline|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731457|NCT00122109|P2|Participant Flow|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention face-to-face traditional modality as compared to the experimental condition which is the via a videoteleconferencing modality .~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731458|NCT00122109|P1|Participant Flow|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731459|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
731460|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731461|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
731462|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
731463|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
731464|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
731465|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
731718|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731466|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731467|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
731468|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
731469|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
731470|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
731471|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
731472|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
731473|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
731474|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
731475|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via the traditional face to face modality as compared to the control condition which is the experimental videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731476|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731477|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
731478|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
731479|NCT00122109|E2|Reported Event|Face to Face AMT|"The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731480|NCT00122109|E1|Reported Event|Videoteleconferencing AMT|"The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
731481|NCT00121836|B1|Baseline|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
731482|NCT00121836|P1|Participant Flow|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
731483|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
731484|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
731719|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731720|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731485|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
731486|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
731487|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
731488|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
731489|NCT00121836|E1|Reported Event|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
731490|NCT00121810|B3|Baseline|Total|Total of all reporting groups
731491|NCT00121810|B2|Baseline|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731492|NCT00121810|B1|Baseline|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731493|NCT00121810|P2|Participant Flow|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731494|NCT00121810|P1|Participant Flow|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731495|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731496|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731497|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731498|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731499|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731500|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731501|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731502|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731503|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731504|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731505|NCT00121810|E2|Reported Event|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
731506|NCT00121810|E1|Reported Event|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
731507|NCT00121719|B15|Baseline|Total|Total of all reporting groups
731721|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731722|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731848|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731508|NCT00121719|B14|Baseline|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731509|NCT00121719|B13|Baseline|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731510|NCT00121719|B12|Baseline|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731511|NCT00121719|B11|Baseline|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731512|NCT00121719|B10|Baseline|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731513|NCT00121719|B9|Baseline|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731514|NCT00121719|B8|Baseline|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731515|NCT00121719|B7|Baseline|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731516|NCT00121719|B6|Baseline|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731723|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731961|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731517|NCT00121719|B5|Baseline|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731518|NCT00121719|B4|Baseline|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731519|NCT00121719|B3|Baseline|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731520|NCT00121719|B2|Baseline|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731521|NCT00121719|B1|Baseline|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731522|NCT00121719|P14|Participant Flow|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731523|NCT00121719|P13|Participant Flow|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731524|NCT00121719|P12|Participant Flow|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731525|NCT00121719|P11|Participant Flow|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731724|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731849|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731526|NCT00121719|P10|Participant Flow|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731527|NCT00121719|P9|Participant Flow|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731528|NCT00121719|P8|Participant Flow|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731529|NCT00121719|P7|Participant Flow|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731530|NCT00121719|P6|Participant Flow|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731531|NCT00121719|P5|Participant Flow|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731532|NCT00121719|P4|Participant Flow|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731533|NCT00121719|P3|Participant Flow|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731725|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731726|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731962|NCT00121485|E2|Reported Event|HeartMate XVE|Implantation of HeartMate XVE LVAS
731534|NCT00121719|P2|Participant Flow|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731535|NCT00121719|P1|Participant Flow|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731536|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731537|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731538|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731539|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731540|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731541|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731542|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731543|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731727|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731728|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731963|NCT00121485|E1|Reported Event|HeartMate II|Implantation of HeartMate II LVAS
731544|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731545|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731546|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731547|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731548|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731549|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731550|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731551|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731729|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731730|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731731|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731552|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731553|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731554|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731555|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731556|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731557|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731558|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731559|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731732|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731733|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731850|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731560|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731561|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731562|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731563|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731564|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731565|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731566|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731567|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731734|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731735|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
733348|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
731568|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731569|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731570|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731571|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731572|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731573|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731574|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731575|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731736|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731737|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731738|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731576|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731577|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731578|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731579|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731580|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731581|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731582|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731583|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731739|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731740|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731851|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731584|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731585|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731586|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731587|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731588|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731589|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731590|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731591|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731741|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731742|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
733349|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
731592|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731593|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731594|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731595|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731596|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731597|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731598|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731599|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731743|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731744|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731745|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731600|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731601|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731602|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731603|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731604|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731605|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731606|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731607|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731746|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731747|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
733350|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
731608|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731609|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731610|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731611|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731612|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731613|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731614|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731615|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731748|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731749|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731852|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731616|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731617|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731618|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731619|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731620|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731621|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731622|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731623|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731750|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731751|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731752|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731624|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731625|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731626|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731627|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731628|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731629|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731630|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731631|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731753|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731754|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
733351|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
731632|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731633|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731634|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731635|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731636|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731637|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731638|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731639|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731755|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731756|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731853|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731640|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731641|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731642|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731643|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731644|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731645|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731646|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731647|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731757|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731758|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731759|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731648|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731649|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731650|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731651|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731652|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731653|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731654|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731655|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731760|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731761|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731854|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731656|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731657|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731658|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731659|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731660|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731661|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731662|NCT00121719|O4|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
731663|NCT00121719|O3|Outcome|25 mg Lenvatinib|Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
731664|NCT00121719|O2|Outcome|12 - 20 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
731665|NCT00121719|O1|Outcome|0.2 - 6.4 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
731666|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
747661|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
731667|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731668|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731669|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731670|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731671|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731672|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731673|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731674|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731762|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731763|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731953|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731675|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731676|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731677|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731678|NCT00121719|O14|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731679|NCT00121719|O13|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731680|NCT00121719|O12|Outcome|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731681|NCT00121719|O11|Outcome|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731682|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731683|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731764|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731765|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731684|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731685|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731686|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731687|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731688|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731689|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731690|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731691|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731766|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731767|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731768|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
747662|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
731692|NCT00121719|O1|Outcome|Lenvatinib|"Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.~Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib."
731693|NCT00121719|E14|Reported Event|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731694|NCT00121719|E13|Reported Event|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731695|NCT00121719|E12|Reported Event|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731696|NCT00121719|E11|Reported Event|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
731697|NCT00121719|E10|Reported Event|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731698|NCT00121719|E9|Reported Event|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731699|NCT00121719|E8|Reported Event|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731700|NCT00121719|E7|Reported Event|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731769|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731954|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
731701|NCT00121719|E6|Reported Event|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.
731702|NCT00121719|E5|Reported Event|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731703|NCT00121719|E4|Reported Event|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731704|NCT00121719|E3|Reported Event|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731705|NCT00121719|E2|Reported Event|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
731706|NCT00121719|E1|Reported Event|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
731707|NCT00121667|B5|Baseline|Total|Total of all reporting groups
731708|NCT00121667|B4|Baseline|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731709|NCT00121667|B3|Baseline|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731710|NCT00121667|B2|Baseline|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731711|NCT00121667|B1|Baseline|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731712|NCT00121667|P4|Participant Flow|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731713|NCT00121667|P3|Participant Flow|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731714|NCT00121667|P2|Participant Flow|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731715|NCT00121667|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731716|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731717|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731955|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731770|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731771|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731772|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731773|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731774|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731775|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731776|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731777|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731778|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731779|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731780|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731781|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731782|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731783|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731784|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731785|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731786|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731787|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731788|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731789|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731790|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731791|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731792|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731793|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731794|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731795|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731796|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731797|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731798|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731799|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731800|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731801|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731802|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731803|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731804|NCT00121667|E4|Reported Event|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731805|NCT00121667|E3|Reported Event|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731806|NCT00121667|E2|Reported Event|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731807|NCT00121667|E1|Reported Event|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
731808|NCT00121641|B5|Baseline|Total|Total of all reporting groups
731809|NCT00121641|B4|Baseline|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731810|NCT00121641|B3|Baseline|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731811|NCT00121641|B2|Baseline|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731812|NCT00121641|B1|Baseline|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731813|NCT00121641|P5|Participant Flow|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731814|NCT00121641|P4|Participant Flow|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731815|NCT00121641|P3|Participant Flow|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731816|NCT00121641|P2|Participant Flow|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731817|NCT00121641|P1|Participant Flow|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Metformin 500-2000 mg (as needed for rescue).
731818|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731819|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731820|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731821|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731822|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731823|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731824|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731825|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731826|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731827|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731828|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731829|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731830|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731831|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731832|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731833|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731834|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731835|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731836|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731837|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731838|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731839|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731840|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731841|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731842|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731843|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731844|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731845|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731846|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731956|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
731855|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731856|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731857|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731858|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731859|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731860|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731861|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731862|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731863|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731864|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731865|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731866|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731867|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731868|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731869|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731870|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731871|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731872|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731873|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731874|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731875|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731876|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731877|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731878|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731879|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731880|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731881|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731882|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731883|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731884|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731885|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731886|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731887|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731888|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731889|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731890|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731891|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731892|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731893|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731894|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731895|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731896|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731897|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731898|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
747663|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
731899|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731900|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731901|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731902|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731903|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731904|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731905|NCT00121641|O1|Outcome|Open-Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731906|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731907|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731908|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731909|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731910|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731911|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731912|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731913|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731914|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731915|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731916|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731917|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731918|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731919|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731920|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731921|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731922|NCT00121641|E5|Reported Event|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731923|NCT00121641|E4|Reported Event|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731924|NCT00121641|E3|Reported Event|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731925|NCT00121641|E2|Reported Event|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
731926|NCT00121641|E1|Reported Event|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
731927|NCT00121485|B3|Baseline|Total|Total of all reporting groups
731928|NCT00121485|B2|Baseline|HeartMate XVE|Implantation of HeartMate XVE LVAS
731929|NCT00121485|B1|Baseline|HeartMate II|Implantation of HeartMate II LVAS
731930|NCT00121485|P2|Participant Flow|HeartMate XVE|Implantation of HeartMate XVE LVAS
731931|NCT00121485|P1|Participant Flow|HeartMate II|Implantation of HeartMate II LVAS
731932|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731933|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731934|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731935|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731936|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731937|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731938|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731939|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731940|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731941|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731942|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731943|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731944|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731945|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731946|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
731947|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731948|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
731949|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731950|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
731951|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
731952|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
731964|NCT00121472|B1|Baseline|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
731965|NCT00121472|P1|Participant Flow|HeartMate II (HMII)|HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).
731966|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
731967|NCT00121472|O1|Outcome|HMII Replacement|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
731968|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
731969|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
731970|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
731971|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
731972|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
731973|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
731974|NCT00121472|E1|Reported Event|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
731975|NCT00121238|B1|Baseline|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
731976|NCT00121238|P1|Participant Flow|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
731977|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
731978|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
731979|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
731980|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
731981|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
733352|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
731982|NCT00121238|E1|Reported Event|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
731983|NCT00121225|B1|Baseline|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
731984|NCT00121225|P1|Participant Flow|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
731985|NCT00121225|O1|Outcome|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
731986|NCT00121225|E1|Reported Event|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
731987|NCT00121199|B1|Baseline|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
731988|NCT00121199|P1|Participant Flow|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
731989|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
731990|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
731991|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
731992|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
731993|NCT00121199|E1|Reported Event|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
731994|NCT00121186|B1|Baseline|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
731995|NCT00121186|P1|Participant Flow|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
731996|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
731997|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
731998|NCT00121186|E1|Reported Event|Nonmyeloablative Allogeneic Stem Cell Transplant|
731999|NCT00121134|B5|Baseline|Total|Total of all reporting groups
732000|NCT00121134|B4|Baseline|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
732001|NCT00121134|B3|Baseline|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
732002|NCT00121134|B2|Baseline|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
732003|NCT00121134|B1|Baseline|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
732004|NCT00121134|P4|Participant Flow|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
732005|NCT00121134|P3|Participant Flow|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
732006|NCT00121134|P2|Participant Flow|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
732007|NCT00121134|P1|Participant Flow|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
732008|NCT00121134|O4|Outcome|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
732009|NCT00121134|O3|Outcome|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
732010|NCT00121134|O2|Outcome|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
732011|NCT00121134|O1|Outcome|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
732012|NCT00121134|E4|Reported Event|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
732013|NCT00121134|E3|Reported Event|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
732014|NCT00121134|E2|Reported Event|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
732015|NCT00121134|E1|Reported Event|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
732016|NCT00120874|B3|Baseline|Total|Total of all reporting groups
732017|NCT00120874|B2|Baseline|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732018|NCT00120874|B1|Baseline|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732019|NCT00120874|P2|Participant Flow|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732020|NCT00120874|P1|Participant Flow|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732021|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732022|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732023|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732024|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732025|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732026|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732027|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732028|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732029|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732030|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732031|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732032|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732033|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732315|NCT00118898|P1|Participant Flow|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732034|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732035|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732036|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732037|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732038|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732039|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732040|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732041|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732042|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732043|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732044|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732045|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732046|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732047|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732048|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732049|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732050|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732051|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732052|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732053|NCT00120874|E2|Reported Event|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
732054|NCT00120874|E1|Reported Event|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
732055|NCT00120627|B3|Baseline|Total|Total of all reporting groups
747664|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
732056|NCT00120627|B2|Baseline|Control Arm: Medication & Case Management Alone|"Usual care consisting of medication and case-management.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732057|NCT00120627|B1|Baseline|Treatment Arm: Mantram + Medication & Case Management|"Mantram Repetition Program (MRP) for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools were presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states."
732058|NCT00120627|P2|Participant Flow|Arm 2: Usual Care|"Usual care consisting of medication and case-management.~Usual care consisted of medication and case management: Case management consisted of provider meetings with Veterans at least once per month and monitoring medications, if prescribed."
732059|NCT00120627|P1|Participant Flow|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732060|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732061|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
732062|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732063|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
732064|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732065|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program (MRP) for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources."
732066|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732067|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732137|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
732068|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732069|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732070|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732071|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732072|NCT00120627|O2|Outcome|Arm 2: Meds & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732073|NCT00120627|O1|Outcome|Arm 1: Mantram + Meds & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732074|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732075|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting.."
732076|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732077|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732078|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
732079|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732080|NCT00120627|E2|Reported Event|Arm 2|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
747665|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
732081|NCT00120627|E1|Reported Event|Arm 1|"he MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
732082|NCT00120523|B3|Baseline|Total|Total of all reporting groups
732083|NCT00120523|B2|Baseline|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732084|NCT00120523|B1|Baseline|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732085|NCT00120523|P2|Participant Flow|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732086|NCT00120523|P1|Participant Flow|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732087|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732088|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732089|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732090|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732091|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732092|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732093|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732094|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732095|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732096|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732097|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732098|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732099|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732100|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732101|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732102|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732358|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732103|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732104|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732105|NCT00120523|E2|Reported Event|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
732106|NCT00120523|E1|Reported Event|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
732107|NCT00120406|B3|Baseline|Total|Total of all reporting groups
732108|NCT00120406|B2|Baseline|PTA (Control)|Percutaneous balloon angioplasty
732109|NCT00120406|B1|Baseline|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
732110|NCT00120406|P2|Participant Flow|PTA (Control)|Percutaneous balloon angioplasty
732111|NCT00120406|P1|Participant Flow|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
732112|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
732113|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
732114|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
732115|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
732116|NCT00120406|E2|Reported Event|PTA (Control)|Percutaneous balloon angioplasty
732117|NCT00120406|E1|Reported Event|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
732118|NCT00120289|B3|Baseline|Total|Total of all reporting groups
732119|NCT00120289|B2|Baseline|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732120|NCT00120289|B1|Baseline|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732121|NCT00120289|P2|Participant Flow|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732122|NCT00120289|P1|Participant Flow|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732123|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732124|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732125|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732126|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732127|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732128|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732129|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732130|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732131|NCT00120289|E2|Reported Event|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732132|NCT00120289|E1|Reported Event|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
732133|NCT00120250|B1|Baseline|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732134|NCT00120250|P2|Participant Flow|Placebo, Then Eszopiclone|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
732135|NCT00120250|P1|Participant Flow|Eszopiclone, Then Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
732136|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
732359|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732138|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732139|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732140|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732141|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732142|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732143|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732144|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732145|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732146|NCT00120250|E1|Reported Event|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
732147|NCT00120042|B4|Baseline|Total|Total of all reporting groups
732148|NCT00120042|B3|Baseline|3|Oral misoprostol to assist in placental delivery
732149|NCT00120042|B2|Baseline|2|Intramuscular oxytocin injection
732150|NCT00120042|B1|Baseline|1|No specific oxytocic to assist in placental delivery
732151|NCT00120042|P3|Participant Flow|3|Oral misoprostol to assist in placental delivery
732152|NCT00120042|P2|Participant Flow|2|Intramuscular oxytocin injection
732153|NCT00120042|P1|Participant Flow|1|No specific oxytocic to assist in placental delivery
732154|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
732155|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
732156|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
732157|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
732158|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
732159|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
732160|NCT00119678|B3|Baseline|Total|Total of all reporting groups
732161|NCT00119678|B2|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732162|NCT00119678|B1|Baseline|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732163|NCT00119678|P2|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732177|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732178|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732164|NCT00119678|P1|Participant Flow|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732165|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732166|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732167|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg). Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. BILAG A: presence of one or more serious features of lupus; BILAG B: more moderate features of the disease; BILAG C: mild symptomatic features; BILAG D: prior activity with no current symptoms due to active lupus; BILAG E: an organ that has never been involved."
732168|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732169|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732170|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732171|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732172|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732173|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732174|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732175|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732176|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
732253|NCT00119158|B3|Baseline|Total|Total of all reporting groups
733353|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
732179|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732180|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732181|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732182|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732183|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732184|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732185|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732186|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732311|NCT00118898|B1|Baseline|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732187|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732188|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732189|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732190|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732191|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732192|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732193|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732194|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732402|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732195|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732196|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732197|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732198|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732199|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732200|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732201|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732202|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732403|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732203|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732204|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732205|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732206|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732207|NCT00119678|E2|Reported Event|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
732208|NCT00119678|E1|Reported Event|Abatacept|"Participants were administered abatacept (10 mg/kg) IV over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
732209|NCT00119405|B1|Baseline|ARV Naive|ARV naive
732210|NCT00119405|P1|Participant Flow|ARV Naive|ARV naive
732211|NCT00119405|O1|Outcome|ARV Naive|ARV naive (have never been on antiretrovirals before)
732212|NCT00119405|E1|Reported Event|ARV Naive|ARV naive (have never been on antiretrovirals before)
732213|NCT00119392|B1|Baseline|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732214|NCT00119392|P1|Participant Flow|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732215|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732312|NCT00118898|P4|Participant Flow|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732216|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732217|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732218|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732219|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732220|NCT00119392|E1|Reported Event|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
732221|NCT00119379|B3|Baseline|Total|Total of all reporting groups
732222|NCT00119379|B2|Baseline|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732223|NCT00119379|B1|Baseline|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732224|NCT00119379|P2|Participant Flow|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732225|NCT00119379|P1|Participant Flow|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732226|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732227|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732228|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732229|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732230|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732231|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732232|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732233|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732234|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732235|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732236|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732237|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732238|NCT00119379|E2|Reported Event|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
732239|NCT00119379|E1|Reported Event|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
732240|NCT00119262|B3|Baseline|Total|Total of all reporting groups
732241|NCT00119262|B2|Baseline|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
732242|NCT00119262|B1|Baseline|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
732243|NCT00119262|P2|Participant Flow|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
732244|NCT00119262|P1|Participant Flow|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
732245|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
732246|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
732247|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
732248|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
732249|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
732250|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
732251|NCT00119262|E2|Reported Event|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
732252|NCT00119262|E1|Reported Event|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
732254|NCT00119158|B2|Baseline|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732255|NCT00119158|B1|Baseline|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732256|NCT00119158|P2|Participant Flow|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732257|NCT00119158|P1|Participant Flow|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732258|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732259|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732260|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732261|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732262|NCT00119158|E2|Reported Event|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732263|NCT00119158|E1|Reported Event|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
732264|NCT00119041|B4|Baseline|Total|Total of all reporting groups
732265|NCT00119041|B3|Baseline|Provider Interview|Qualitative interviews with providers
732266|NCT00119041|B2|Baseline|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
732267|NCT00119041|B1|Baseline|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.~We did not collect gender and age related data."
732268|NCT00119041|P3|Participant Flow|Provider Interview|Qualitative interviews with providers
732269|NCT00119041|P2|Participant Flow|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
732270|NCT00119041|P1|Participant Flow|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
732271|NCT00119041|O2|Outcome|Control|non intervention group
732272|NCT00119041|O1|Outcome|Telemedicine|Intervention group
732273|NCT00119041|O2|Outcome|Control CBOC|Received the questionnaires by mail and had no intervention of diabetes teleconference
732274|NCT00119041|O1|Outcome|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
732275|NCT00119041|E3|Reported Event|Provider Interviews|Qualitative interviews with providers.
732276|NCT00119041|E2|Reported Event|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
732313|NCT00118898|P3|Participant Flow|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732314|NCT00118898|P2|Participant Flow|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
733354|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
732277|NCT00119041|E1|Reported Event|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
732278|NCT00119015|B3|Baseline|Total|Total of all reporting groups
732279|NCT00119015|B2|Baseline|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
732280|NCT00119015|B1|Baseline|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
732281|NCT00119015|P3|Participant Flow|Fluticasone Propionate+Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Placebo - 10 mg po daily"
732282|NCT00119015|P2|Participant Flow|Fluticasone Propionate+Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Montelukast - 10 mg po daily"
732283|NCT00119015|P1|Participant Flow|Fluticasone Propionate Only|Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
732284|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
732285|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
732286|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
732287|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
732288|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
732289|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
732290|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
732291|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
732292|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
732293|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
732294|NCT00119015|E2|Reported Event|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
732295|NCT00119015|E1|Reported Event|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
732296|NCT00118911|B3|Baseline|Total|Total of all reporting groups
732297|NCT00118911|B2|Baseline|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
732298|NCT00118911|B1|Baseline|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
732299|NCT00118911|P2|Participant Flow|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
732300|NCT00118911|P1|Participant Flow|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
732301|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
732302|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
732303|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
732304|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
732305|NCT00118911|E2|Reported Event|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
732306|NCT00118911|E1|Reported Event|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
732307|NCT00118898|B5|Baseline|Total|Total of all reporting groups
732308|NCT00118898|B4|Baseline|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732309|NCT00118898|B3|Baseline|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732310|NCT00118898|B2|Baseline|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732316|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732317|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732318|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732319|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732320|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732321|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732322|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732323|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732324|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732325|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732326|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732327|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732328|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732329|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732330|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732331|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732332|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732333|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732334|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732335|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732336|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732337|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732338|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732339|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732340|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732341|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732342|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732343|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732344|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732345|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732346|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732347|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732348|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732349|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732350|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732351|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732352|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732353|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732354|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732355|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732356|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732357|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732360|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732361|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732362|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732363|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732364|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732365|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732366|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732367|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732368|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732369|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732370|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732371|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732372|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732373|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732374|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732375|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732376|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732377|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732378|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732379|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732380|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732381|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732382|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732383|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732384|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732385|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732386|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732387|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732388|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732389|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732390|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732391|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732392|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732393|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732394|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732395|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732396|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732397|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732398|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732399|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732400|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732401|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732404|NCT00118898|E4|Reported Event|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732405|NCT00118898|E3|Reported Event|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732406|NCT00118898|E2|Reported Event|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
732407|NCT00118898|E1|Reported Event|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
732408|NCT00118755|B3|Baseline|Total|Total of all reporting groups
732409|NCT00118755|B2|Baseline|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
732410|NCT00118755|B1|Baseline|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
732411|NCT00118755|P2|Participant Flow|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
732412|NCT00118755|P1|Participant Flow|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
732413|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
732414|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
732415|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
732416|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
732417|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
732418|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
732419|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
732420|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
732421|NCT00118755|E2|Reported Event|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
732422|NCT00118755|E1|Reported Event|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
732423|NCT00118742|B3|Baseline|Total|Total of all reporting groups
732424|NCT00118742|B2|Baseline|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
732425|NCT00118742|B1|Baseline|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
732426|NCT00118742|P2|Participant Flow|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
732427|NCT00118742|P1|Participant Flow|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
732428|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
732429|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
732430|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
732431|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
733355|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
732432|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
732433|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
732434|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
732435|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
732436|NCT00118742|E2|Reported Event|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
732437|NCT00118742|E1|Reported Event|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
732438|NCT00118703|B3|Baseline|Total|Total of all reporting groups
732439|NCT00118703|B2|Baseline|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732440|NCT00118703|B1|Baseline|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732441|NCT00118703|P2|Participant Flow|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732442|NCT00118703|P1|Participant Flow|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian [AM]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732443|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732444|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732445|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732446|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732447|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732448|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732449|NCT00118703|E2|Reported Event|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732450|NCT00118703|E1|Reported Event|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
732451|NCT00118534|B3|Baseline|Total|Total of all reporting groups
732452|NCT00118534|B2|Baseline|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732453|NCT00118534|B1|Baseline|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732454|NCT00118534|P2|Participant Flow|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732455|NCT00118534|P1|Participant Flow|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732456|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732457|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732458|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732459|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732460|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732461|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732462|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732463|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
733356|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
732464|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732465|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732466|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732467|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732468|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732469|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732470|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732471|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732472|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732473|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732474|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732475|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732476|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732477|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732478|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732479|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732480|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732481|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732482|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732483|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732484|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732485|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732486|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732487|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732488|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732489|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732490|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732491|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732492|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732493|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732494|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732495|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732496|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732497|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732498|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732499|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732500|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732501|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732502|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732503|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732504|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732505|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732506|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732507|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732508|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732509|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732510|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732511|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732512|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732513|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
733357|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
732514|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732515|NCT00118534|O1|Outcome|Integrated Care|Integration of Smoking Cessation therapy with PTSD therapy.
732516|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732517|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732518|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732519|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732520|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732521|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732522|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732523|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732524|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732525|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732526|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732527|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732528|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732529|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732530|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732531|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732532|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732533|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732534|NCT00118534|E2|Reported Event|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
732535|NCT00118534|E1|Reported Event|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
732536|NCT00118482|B3|Baseline|Total|Total of all reporting groups
732537|NCT00118482|B2|Baseline|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732538|NCT00118482|B1|Baseline|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732539|NCT00118482|P2|Participant Flow|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732540|NCT00118482|P1|Participant Flow|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732541|NCT00118482|O2|Outcome|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732542|NCT00118482|O1|Outcome|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732543|NCT00118482|O2|Outcome|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732544|NCT00118482|O1|Outcome|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732545|NCT00118482|E2|Reported Event|Placebo|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732546|NCT00118482|E1|Reported Event|Fludrocortisone Acetate|fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
732547|NCT00118430|B4|Baseline|Total|Total of all reporting groups
732548|NCT00118430|B3|Baseline|No Treatment|Participants without depression group
732549|NCT00118430|B2|Baseline|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
732550|NCT00118430|B1|Baseline|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
732551|NCT00118430|P3|Participant Flow|No Treatment|Participants without depression group
732552|NCT00118430|P2|Participant Flow|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
732568|NCT00118417|P2|Participant Flow|Sertraline / + Placebo / Cognitive Behavior Therapy Augment.|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)
732651|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732553|NCT00118430|P1|Participant Flow|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly with a physician-investigator to review cases, the physician-investigator will be available at all times to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response~Antidepressants: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg"
732554|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
732555|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
732556|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
732557|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
732558|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
732559|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
732560|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
732561|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
732562|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
732563|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
732564|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
732565|NCT00118430|E2|Reported Event|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
732566|NCT00118430|E1|Reported Event|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
732567|NCT00118417|B1|Baseline|All Participants|
732646|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
732647|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
732569|NCT00118417|P1|Participant Flow|Sertraline / Increased Dose / Medication Optimization|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam
732570|NCT00118417|O2|Outcome|Augmented Cognitive Behavior Therapy|This group will receive sertraline or escitalopram with cognitive behavioral therapy (CBT)
732571|NCT00118417|O1|Outcome|Medication Optimization|This group will receive medication optimization, which includes sertraline or escitalopram with clonazepam
732572|NCT00118417|O2|Outcome|Sertraline Plus Placebo|This group will receive sertraline or escitalopram with a placebo
732573|NCT00118417|O1|Outcome|Increased Sertraline|This group will receive an increased dosage of sertraline or escitalopram
732574|NCT00118417|O1|Outcome|Moderate Sertraline Treatment|This group will receive moderate sertraline or escitalopram treatment
732575|NCT00118417|E3|Reported Event|Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam|
732576|NCT00118417|E2|Reported Event|Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone|
732577|NCT00118417|E1|Reported Event|Phase I: Sertraline|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI).
732578|NCT00118404|B4|Baseline|Total|Total of all reporting groups
732579|NCT00118404|B3|Baseline|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
732580|NCT00118404|B2|Baseline|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
732581|NCT00118404|B1|Baseline|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
732582|NCT00118404|P3|Participant Flow|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
732583|NCT00118404|P2|Participant Flow|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
732584|NCT00118404|P1|Participant Flow|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
732585|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
732586|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
732587|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
732588|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
732589|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
732590|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
732591|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
732592|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
732593|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
732648|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
732649|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
732594|NCT00118404|E3|Reported Event|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
732595|NCT00118404|E2|Reported Event|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
732596|NCT00118404|E1|Reported Event|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
732597|NCT00118378|B3|Baseline|Total|Total of all reporting groups
732598|NCT00118378|B2|Baseline|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
732599|NCT00118378|B1|Baseline|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
732600|NCT00118378|P2|Participant Flow|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
732601|NCT00118378|P1|Participant Flow|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
732602|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
732603|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
732604|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
732605|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
732606|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
732607|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
732608|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
732609|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
732610|NCT00118378|E2|Reported Event|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
732611|NCT00118378|E1|Reported Event|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
732612|NCT00118365|B3|Baseline|Total|Total of all reporting groups
732613|NCT00118365|B2|Baseline|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732614|NCT00118365|B1|Baseline|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732615|NCT00118365|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732616|NCT00118365|P1|Participant Flow|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732617|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732618|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732619|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732620|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732621|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732622|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732623|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732650|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
732783|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732624|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732625|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732626|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732627|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732628|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732629|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732630|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732631|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732632|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732633|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732634|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732635|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732636|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732637|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732638|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732639|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732640|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732641|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732642|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732643|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732644|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732645|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
732652|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732653|NCT00118365|O4|Outcome|Placebo + Spd:Spm Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
732654|NCT00118365|O3|Outcome|Placebo + Spd:Spm Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~SpSpd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
732655|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Spd:Spm Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
732656|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Spd:Spm Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
732657|NCT00118365|O4|Outcome|Placebo + Putrescine Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
732658|NCT00118365|O3|Outcome|Placebo + Putrescine Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
732659|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Putrescine Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
732660|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Putrescine Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
732661|NCT00118365|O4|Outcome|Placebo + PGE2 Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
732662|NCT00118365|O3|Outcome|Placebo + PGE2 Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
732663|NCT00118365|O2|Outcome|Eflornithine and Sulindac + PGE2 Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
732664|NCT00118365|O1|Outcome|Eflornithine and Sulindac + PGE2 Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
732665|NCT00118365|O4|Outcome|Placebo + High Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above median"
732666|NCT00118365|O3|Outcome|Placebo + Low Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below median"
732667|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above the median"
732668|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below the median"
732897|NCT00117806|B2|Baseline|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
732669|NCT00118365|O4|Outcome|Placebo + High Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is above median"
732670|NCT00118365|O3|Outcome|Placebo + Low Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is below median"
732671|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is above the median"
732672|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is below the median"
732673|NCT00118365|O4|Outcome|Placebo + High PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is above median"
732674|NCT00118365|O3|Outcome|Placebo + Low PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is below median"
732675|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is above the median"
732676|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is below the median"
732677|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732678|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732679|NCT00118365|E2|Reported Event|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
732680|NCT00118365|E1|Reported Event|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
732681|NCT00118352|B4|Baseline|Total|Total of all reporting groups
732682|NCT00118352|B3|Baseline|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732683|NCT00118352|B2|Baseline|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732684|NCT00118352|B1|Baseline|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732685|NCT00118352|P3|Participant Flow|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation~NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
732686|NCT00118352|P2|Participant Flow|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation~NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
732687|NCT00118352|P1|Participant Flow|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732688|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732689|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732690|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732691|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732692|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732693|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732694|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732695|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732696|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732697|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732698|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732699|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732700|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
733358|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
732701|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732702|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732703|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732704|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732705|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732706|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732707|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732708|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732709|NCT00118352|E3|Reported Event|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732710|NCT00118352|E2|Reported Event|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732711|NCT00118352|E1|Reported Event|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
732712|NCT00118287|B1|Baseline|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
732713|NCT00118287|P1|Participant Flow|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
732714|NCT00118287|O1|Outcome|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
732715|NCT00118287|E1|Reported Event|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
732716|NCT00118248|B3|Baseline|Total|Total of all reporting groups
747666|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
732717|NCT00118248|B2|Baseline|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732718|NCT00118248|B1|Baseline|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732719|NCT00118248|P2|Participant Flow|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732720|NCT00118248|P1|Participant Flow|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732721|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732722|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732723|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732724|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732725|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732726|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732727|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732728|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732729|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732730|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732731|NCT00118248|E1|Reported Event|All Patients|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
732732|NCT00118157|B1|Baseline|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
732733|NCT00118157|P1|Participant Flow|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
732734|NCT00118157|O1|Outcome|Treatment (Lapatinib, Tamoxifen)|"Patients receive lapatinib ditosylate PO daily and tamoxifen citrate PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Lapatinib Ditosylate: Given PO~Tamoxifen Citrate: Given PO"
732735|NCT00118157|O1|Outcome|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
732736|NCT00118157|E1|Reported Event|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
732737|NCT00118144|B1|Baseline|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
732738|NCT00118144|P1|Participant Flow|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
732739|NCT00118144|O1|Outcome|Arm I|"Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.~bortezomib: Given IV"
732740|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
732741|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
732742|NCT00118144|E1|Reported Event|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
732743|NCT00118131|B1|Baseline|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
732744|NCT00118131|P1|Participant Flow|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
732745|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
732746|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
732958|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732747|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
732748|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
732749|NCT00118131|E1|Reported Event|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
732750|NCT00118092|B1|Baseline|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
732751|NCT00118092|P1|Participant Flow|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
732752|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|"Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.~> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
732753|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
732754|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
732755|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|"Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.~> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
732756|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
732757|NCT00118092|E1|Reported Event|Treatment (Tanespimycin)|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
732758|NCT00118053|B1|Baseline|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
732759|NCT00118053|P1|Participant Flow|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
732760|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
732761|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
732784|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732785|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
733209|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
732762|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
732763|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
732764|NCT00118053|E1|Reported Event|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
732765|NCT00118040|B4|Baseline|Total|Total of all reporting groups
732766|NCT00118040|B3|Baseline|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732767|NCT00118040|B2|Baseline|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732768|NCT00118040|B1|Baseline|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732769|NCT00118040|P3|Participant Flow|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732770|NCT00118040|P2|Participant Flow|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732771|NCT00118040|P1|Participant Flow|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732772|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732773|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732774|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732775|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732776|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732777|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732778|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732779|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732780|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732781|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732782|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
747667|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
732786|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732787|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732788|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732789|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732790|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732791|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732792|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732793|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732794|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732795|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732796|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732797|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732798|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732799|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732800|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732801|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732802|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732803|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732804|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732805|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732806|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732807|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732808|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732809|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732810|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732811|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732812|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732813|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732895|NCT00117845|E1|Reported Event|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
732814|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732815|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732816|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732817|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732818|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732819|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732820|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732821|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732822|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732823|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732824|NCT00118040|O4|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
732825|NCT00118040|O3|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732826|NCT00118040|O2|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732827|NCT00118040|O1|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
732828|NCT00118040|E3|Reported Event|Arm III (Placebo)|"Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~laboratory biomarker analysis: Correlative studies~placebo: Given orally~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
732829|NCT00118040|E2|Reported Event|Arm II (Higher Dose Genistein)|"Patients receive oral genistein as in arm I but at a higher dose. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
732830|NCT00118040|E1|Reported Event|Arm I (Lower Dose Genistein)|"Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
732831|NCT00117988|B1|Baseline|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
732832|NCT00117988|P1|Participant Flow|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
732833|NCT00117988|O1|Outcome|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
732834|NCT00117988|E1|Reported Event|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
732835|NCT00117962|B3|Baseline|Total|Total of all reporting groups
732836|NCT00117962|B2|Baseline|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
732837|NCT00117962|B1|Baseline|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
732838|NCT00117962|P2|Participant Flow|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
732839|NCT00117962|P1|Participant Flow|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
732840|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
732841|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
732842|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
732843|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
732844|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
732845|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
732846|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
732847|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
732848|NCT00117962|E2|Reported Event|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
732849|NCT00117962|E1|Reported Event|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
732850|NCT00117949|B5|Baseline|Total|Total of all reporting groups
732851|NCT00117949|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732852|NCT00117949|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732853|NCT00117949|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732854|NCT00117949|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732855|NCT00117949|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732856|NCT00117949|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732857|NCT00117949|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732858|NCT00117949|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732859|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732860|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732861|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732862|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732863|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732864|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732865|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732866|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732867|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732868|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732869|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732870|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732871|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732872|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732873|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732874|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732875|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732876|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732877|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732878|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732879|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732880|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732881|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732882|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732883|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732884|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732885|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732886|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732887|NCT00117949|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
732888|NCT00117949|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
732889|NCT00117949|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
732890|NCT00117949|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
732891|NCT00117845|B1|Baseline|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
732892|NCT00117845|P1|Participant Flow|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
732893|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
732894|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
732896|NCT00117806|B3|Baseline|Total|Total of all reporting groups
732898|NCT00117806|B1|Baseline|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
732899|NCT00117806|P2|Participant Flow|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
732900|NCT00117806|P1|Participant Flow|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
732901|NCT00117806|O2|Outcome|Arm 2|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
732902|NCT00117806|O1|Outcome|Arm 1|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
732903|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
732904|NCT00117806|O1|Outcome|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
732905|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
732906|NCT00117806|O1|Outcome|Supported Employment|Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
732907|NCT00117806|E2|Reported Event|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
732908|NCT00117806|E1|Reported Event|Supported Employment|"SCI-VIP: supported employment implemented for veterans with spinal cord injury~Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury."
732909|NCT00117793|B1|Baseline|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
732910|NCT00117793|P1|Participant Flow|Entire Study Population|"This is a randomized cross-over study. Each participant wore both study prostheses: (1) a total surface bearing socket with a vacuum-assisted suspension system (VASS) and (2) a modified patellar tendon bearing socket with a pin lock suspension system (PIN).~Subjects were randomized, provided with one of two study prostheses, and asked to wear it for three weeks. Data was then collected during laboratory visit one, and, following one more week of wearing the first study prosthesis, during laboratory visit two. Participants were then provided with the second study intervention and asked to wear it for three weeks. Data was then collected during laboratory visit three, and, following one more week of wearing the second study intervention, during laboratory visit four.~Data was not collected on the order in which participants received each study intervention"
732911|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
732912|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
732913|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
732914|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
732915|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
732916|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
732917|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
732918|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
732919|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
732920|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
732921|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
732922|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
732923|NCT00117793|E1|Reported Event|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
732924|NCT00117715|B1|Baseline|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
732925|NCT00117715|P1|Participant Flow|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
732926|NCT00117715|O1|Outcome|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
732927|NCT00117715|O1|Outcome|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
732928|NCT00117715|O1|Outcome|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
732929|NCT00117715|E1|Reported Event|Longitudinal Assessment Cohort|Normal healthy children approximately one year of age followed through five years of age to evaluate the ontogeny of CYP1A2, CYP2D6, CYP3A4.
732930|NCT00117676|B3|Baseline|Total|Total of all reporting groups
732931|NCT00117676|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733210|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
732932|NCT00117676|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732933|NCT00117676|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period.
732934|NCT00117676|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC; as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) to their treatment regimen in the open-label period.
732935|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732936|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732937|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732938|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732939|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732940|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732941|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732942|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732943|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732944|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732945|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732946|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732947|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732948|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732949|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732950|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732951|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732952|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732953|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732954|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732955|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732956|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732957|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732959|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732960|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732961|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732962|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732963|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732964|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732965|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732966|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732967|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732968|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732969|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
732970|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
732971|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732972|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732973|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732974|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732975|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732976|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732977|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732978|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732979|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732980|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732981|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732982|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732983|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732984|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733359|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
732985|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732986|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732987|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732988|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732989|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732990|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732991|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732992|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732993|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732994|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732995|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732996|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732997|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732998|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
732999|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733000|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733001|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733002|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733003|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733004|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733005|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733006|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733007|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733008|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733009|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733010|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733360|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733011|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733012|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733013|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733014|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733015|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733016|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733017|NCT00117676|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 384), regardless of which group they were randomized to in the double-blind period.~TDF 300 mg+ADV placebo or ADV 10 mg+TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period."
733018|NCT00117676|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period)."
733019|NCT00117676|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period)."
733020|NCT00117637|B3|Baseline|Total|Total of all reporting groups
733021|NCT00117637|B2|Baseline|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733022|NCT00117637|B1|Baseline|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733023|NCT00117637|P2|Participant Flow|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733024|NCT00117637|P1|Participant Flow|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733025|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733026|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733027|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733028|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733131|NCT00117585|P1|Participant Flow|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
733029|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733030|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733031|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733032|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733033|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733034|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733035|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733036|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733037|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733038|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733039|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733040|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733041|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733042|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733211|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733043|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733044|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733045|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733046|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733047|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733048|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733049|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733050|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733051|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733052|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733053|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733054|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733055|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733056|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733361|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733057|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733058|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733059|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733060|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733061|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733062|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733063|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733064|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733065|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733066|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733067|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733068|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733069|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733070|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733212|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733362|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733071|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733072|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733073|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733074|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733075|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733076|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733077|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733078|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733079|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733080|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733081|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733082|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733083|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733084|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733213|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733085|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733086|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733087|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733088|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733089|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733090|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733091|NCT00117637|E4|Reported Event|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733092|NCT00117637|E3|Reported Event|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733093|NCT00117637|E2|Reported Event|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
733094|NCT00117637|E1|Reported Event|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
733095|NCT00117598|B4|Baseline|Total|Total of all reporting groups
733096|NCT00117598|B3|Baseline|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733097|NCT00117598|B2|Baseline|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733098|NCT00117598|B1|Baseline|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733099|NCT00117598|P5|Participant Flow|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733100|NCT00117598|P4|Participant Flow|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733101|NCT00117598|P3|Participant Flow|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733102|NCT00117598|P2|Participant Flow|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733103|NCT00117598|P1|Participant Flow|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733104|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733105|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733106|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733107|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733108|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733109|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733110|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733111|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733112|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733113|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733114|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733115|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733132|NCT00117585|O1|Outcome|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
747668|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
733116|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733117|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733118|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733119|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733120|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733121|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733122|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733123|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733124|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733125|NCT00117598|E5|Reported Event|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. AEs presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733126|NCT00117598|E4|Reported Event|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Adverse events (AEs) presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733127|NCT00117598|E3|Reported Event|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
733128|NCT00117598|E2|Reported Event|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
733129|NCT00117598|E1|Reported Event|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Includes participants who received Temsirolimus 175/75 mg prior to crossover (Protocol Amendment 5).
733130|NCT00117585|B1|Baseline|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
733207|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733341|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733133|NCT00117585|E1|Reported Event|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
733134|NCT00117572|B3|Baseline|Total|Total of all reporting groups
733135|NCT00117572|B2|Baseline|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733136|NCT00117572|B1|Baseline|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733137|NCT00117572|P2|Participant Flow|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733138|NCT00117572|P1|Participant Flow|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733139|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733140|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733141|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733142|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733143|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733208|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733342|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
747669|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
733144|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733145|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733146|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733147|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733148|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733149|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733150|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733151|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733152|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733153|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
747670|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
733154|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733155|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733156|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733157|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733158|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733159|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733160|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733161|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733162|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733163|NCT00117572|O2|Outcome|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
747671|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
733164|NCT00117572|O1|Outcome|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733165|NCT00117572|E2|Reported Event|Chemoradiotherapy|"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733166|NCT00117572|E1|Reported Event|Induction Plus Chemoradiotherapy|"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.~Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.~docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)~cisplatin: 75 mg/m2 on day 1~hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)~fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)~chemotherapy: See protocol for details~radiotherapy: See protocol for details"
733167|NCT00117559|B3|Baseline|Total|Total of all reporting groups
733168|NCT00117559|B2|Baseline|Treatment as Usual|Control group
733169|NCT00117559|B1|Baseline|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
733170|NCT00117559|P2|Participant Flow|Treatment as Usual|Control group
733171|NCT00117559|P1|Participant Flow|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
733172|NCT00117559|O2|Outcome|Treatment as Usual|Control group
733173|NCT00117559|O1|Outcome|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
733174|NCT00117559|E2|Reported Event|Treatment as Ususal|Control group
733175|NCT00117559|E1|Reported Event|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
733176|NCT00117338|B3|Baseline|Total|Total of all reporting groups
733177|NCT00117338|B2|Baseline|Placebo|
733178|NCT00117338|B1|Baseline|Montelukast Intravenous (IV) 5.25 mg|
733179|NCT00117338|P2|Participant Flow|Placebo|
733180|NCT00117338|P1|Participant Flow|Montelukast Intravenous (IV) 5.25 mg|
733181|NCT00117338|O2|Outcome|Placebo|
733182|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
733183|NCT00117338|O2|Outcome|Placebo|
733184|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
733185|NCT00117338|O2|Outcome|Placebo|
733186|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
733187|NCT00117338|O2|Outcome|Placebo|
733188|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
733189|NCT00117338|O2|Outcome|Placebo|
733190|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
733191|NCT00117338|O2|Outcome|Placebo|
733192|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
733193|NCT00117338|O2|Outcome|Placebo|
733194|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
733195|NCT00117338|E2|Reported Event|Placebo|
733196|NCT00117338|E1|Reported Event|Montelukast Intravenous (IV) 5.25 mg|
733197|NCT00117325|B3|Baseline|Total|Total of all reporting groups
733198|NCT00117325|B2|Baseline|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733199|NCT00117325|B1|Baseline|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733200|NCT00117325|P2|Participant Flow|Fluticasone Furoate 110 mcg QD|Participants received Fluticasone Furoate (GW 685698X) aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733201|NCT00117325|P1|Participant Flow|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 microgram (mcg) administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733202|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733203|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733204|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733205|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733206|NCT00117325|O2|Outcome|Fluticasone Furoate 110mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733343|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733214|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733215|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733216|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733217|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733218|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733219|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733220|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733221|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733222|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733223|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733224|NCT00117325|O2|Outcome|Fluticasone Furoate 110 mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733225|NCT00117325|O1|Outcome|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733226|NCT00117325|E2|Reported Event|Fluticasone Furoate 110mcg QD|Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733227|NCT00117325|E1|Reported Event|Placebo|Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
733228|NCT00117312|B5|Baseline|Total|Total of all reporting groups
733229|NCT00117312|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
733230|NCT00117312|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
733231|NCT00117312|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
733232|NCT00117312|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
733233|NCT00117312|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
733234|NCT00117312|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
733235|NCT00117312|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
733236|NCT00117312|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
733237|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
733238|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
733239|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
733240|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
733241|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
733242|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
733243|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
733244|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
733245|NCT00117312|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
733246|NCT00117312|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
733247|NCT00117312|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
733248|NCT00117312|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
733249|NCT00117286|B3|Baseline|Total|Total of all reporting groups
733250|NCT00117286|B2|Baseline|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733251|NCT00117286|B1|Baseline|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733252|NCT00117286|P2|Participant Flow|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733253|NCT00117286|P1|Participant Flow|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733254|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733255|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733256|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733257|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733258|NCT00117286|E2|Reported Event|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733259|NCT00117286|E1|Reported Event|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
733260|NCT00117156|B1|Baseline|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733261|NCT00117156|P1|Participant Flow|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733262|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733263|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733264|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733265|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733266|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733267|NCT00117156|E1|Reported Event|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
733268|NCT00116857|B3|Baseline|Total|Total of all reporting groups
733269|NCT00116857|B2|Baseline|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
733270|NCT00116857|B1|Baseline|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
733271|NCT00116857|P2|Participant Flow|Sertraline/Corn Oil|Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.
733272|NCT00116857|P1|Participant Flow|Sertraline Plus Omega-3 Supplement|Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.
733273|NCT00116857|O2|Outcome|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
733274|NCT00116857|O1|Outcome|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
733275|NCT00116857|E2|Reported Event|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
733276|NCT00116857|E1|Reported Event|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
733277|NCT00116844|B3|Baseline|Total|Total of all reporting groups
733278|NCT00116844|B2|Baseline|Sequence 2: Placebo, VALTREX 1 g Once Daily|Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
733344|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733279|NCT00116844|B1|Baseline|Sequence 1: VALTREX 1 g Once Daily, Placebo|Participants randomized to this sequence received VALTREX 1 g once daily for 60 days, to be taken as two 500 mg caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
733280|NCT00116844|P2|Participant Flow|Sequence 2: Placebo, VALTREX 1 g Once Daily|Participants randomized to this sequence received matching placebo for 60 days, to be taken as two 500 mg caplets in Period 1 followed by VALTREX 1 g once daily for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
733281|NCT00116844|P1|Participant Flow|Sequence 1: VALTREX 1 g Once Daily, Placebo|Participants randomized to this sequence received VALTREX 1 gram (g) once daily for 60 days, to be taken as two 500 milligram (mg) caplets in Period 1 followed by matching placebo for 60 days in Period 2 with 7 days of washout period between 2 periods. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted.
733282|NCT00116844|O2|Outcome|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733283|NCT00116844|O1|Outcome|VALTREX 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733284|NCT00116844|O2|Outcome|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733285|NCT00116844|O1|Outcome|VALTREX 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733286|NCT00116844|O2|Outcome|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733287|NCT00116844|O1|Outcome|VALTREX 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733288|NCT00116844|O2|Outcome|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733289|NCT00116844|O1|Outcome|VALTREX 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733290|NCT00116844|O2|Outcome|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733291|NCT00116844|O1|Outcome|VALTREX 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733345|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733346|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733347|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733292|NCT00116844|O2|Outcome|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733293|NCT00116844|O1|Outcome|VALTREX 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733294|NCT00116844|E2|Reported Event|Placebo|Participants randomized to this arm received matching placebo once daily for 60 days, to be taken as two caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733295|NCT00116844|E1|Reported Event|Valtrex 1 g Once Daily|Participants randomized to this arm received VALTREX 1g once daily for 60 days, to be taken as two 500 mg caplets in a two-way crossover design. Participants were instructed to take caplets at approximately the same time of day each day, without regard to meals. If a dose was missed, the participants take the dose later that day provided they take it at least 2 hours before their next scheduled dose; otherwise the dose was omitted. There was a washout period of seven days between treatment periods.
733296|NCT00116831|B3|Baseline|Total|Total of all reporting groups
733297|NCT00116831|B2|Baseline|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733298|NCT00116831|B1|Baseline|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733299|NCT00116831|P2|Participant Flow|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733300|NCT00116831|P1|Participant Flow|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733301|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733302|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733303|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733304|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733305|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733306|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733307|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733308|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733309|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733310|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733311|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733312|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733313|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733314|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733315|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733316|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733317|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733318|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733319|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733320|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733321|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733322|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733323|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733324|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733325|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733326|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733327|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733328|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733329|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733330|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733331|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733332|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733333|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733334|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733335|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733336|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733337|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733338|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733339|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733340|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733363|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733364|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733365|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733366|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733367|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733368|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733369|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733370|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733371|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733372|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733373|NCT00116831|E2|Reported Event|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
733374|NCT00116831|E1|Reported Event|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
733375|NCT00116805|B3|Baseline|Total|Total of all reporting groups
733376|NCT00116805|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733377|NCT00116805|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733378|NCT00116805|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733379|NCT00116805|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) in the open-label period.
733380|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733381|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733382|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733383|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733384|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733385|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733386|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733387|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733388|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733389|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733390|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733391|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733392|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733393|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733394|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733395|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733503|NCT00116753|B3|Baseline|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733396|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733397|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733398|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733399|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733400|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733401|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733402|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733403|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733404|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733405|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733406|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733407|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733408|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733409|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733410|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733411|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733412|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733413|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733414|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
733415|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
733416|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733417|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733418|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733419|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733420|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733421|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733504|NCT00116753|B2|Baseline|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733422|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733423|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733424|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733425|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733426|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733427|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733428|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733429|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733430|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733431|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733432|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733433|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733434|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733435|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733436|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733437|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733438|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733439|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733440|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733441|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733442|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733443|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733444|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733445|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733446|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733447|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
734813|NCT00112437|P4|Participant Flow|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
733448|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733449|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733450|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733451|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733452|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733453|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733454|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733455|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period..
733456|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733457|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733458|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733459|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733460|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733461|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733462|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733463|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733464|NCT00116805|O2|Outcome|ADV 10 mg|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733465|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
733466|NCT00116805|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 480), regardless of which group they were randomized to in the double-blind period.~TDF 300 mg + ADV placebo or ADV 10 mg + TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period."
733467|NCT00116805|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period)."
733468|NCT00116805|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period)."
733469|NCT00116779|B3|Baseline|Total|Total of all reporting groups
733470|NCT00116779|B2|Baseline|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733471|NCT00116779|B1|Baseline|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733472|NCT00116779|P2|Participant Flow|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733473|NCT00116779|P1|Participant Flow|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733505|NCT00116753|B1|Baseline|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733474|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733475|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733476|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733477|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733478|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733479|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733480|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733481|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733482|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733483|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733484|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733485|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733486|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733487|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733488|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733489|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733490|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733491|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733492|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733493|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733494|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733495|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733496|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733497|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733498|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733499|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733500|NCT00116779|E2|Reported Event|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
733501|NCT00116779|E1|Reported Event|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
733502|NCT00116753|B4|Baseline|Total|Total of all reporting groups
747672|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
733506|NCT00116753|P3|Participant Flow|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733507|NCT00116753|P2|Participant Flow|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733508|NCT00116753|P1|Participant Flow|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733509|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733510|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733511|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733512|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733513|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733514|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733515|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733516|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733517|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733518|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733519|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733520|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733521|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733522|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733523|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733524|NCT00116753|E3|Reported Event|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
733525|NCT00116753|E2|Reported Event|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
733526|NCT00116753|E1|Reported Event|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
733527|NCT00116688|B3|Baseline|Total|Total of all reporting groups
733528|NCT00116688|B2|Baseline|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
733529|NCT00116688|B1|Baseline|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733530|NCT00116688|P2|Participant Flow|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
733531|NCT00116688|P1|Participant Flow|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733532|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733533|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733534|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733535|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733536|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733537|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
733538|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733539|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
733540|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733541|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
733542|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733543|NCT00116688|E2|Reported Event|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
733544|NCT00116688|E1|Reported Event|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
733545|NCT00116649|B1|Baseline|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
733546|NCT00116649|P1|Participant Flow|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
733547|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
733548|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
733549|NCT00116649|E1|Reported Event|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
733550|NCT00116428|B3|Baseline|Total|Total of all reporting groups
733551|NCT00116428|B2|Baseline|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
733552|NCT00116428|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733553|NCT00116428|P2|Participant Flow|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
733554|NCT00116428|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733555|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
733556|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.
733557|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733698|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733558|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
733559|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.
733560|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733561|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
733562|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733563|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
733564|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733565|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
733566|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733567|NCT00116428|E2|Reported Event|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
733568|NCT00116428|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
733569|NCT00116272|B3|Baseline|Total|Total of all reporting groups
733570|NCT00116272|B2|Baseline|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733571|NCT00116272|B1|Baseline|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733572|NCT00116272|P2|Participant Flow|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733573|NCT00116272|P1|Participant Flow|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733574|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733575|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733576|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733577|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
747673|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
733578|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733579|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733580|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733581|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733582|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733583|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733584|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733585|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733586|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733587|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733588|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733589|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733590|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733591|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733592|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733593|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733594|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733595|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733596|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733597|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733598|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733599|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733600|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733601|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733602|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733603|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733604|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733699|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733605|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733606|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733607|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733608|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733609|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733610|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733611|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733612|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733613|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733614|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733615|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733616|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733617|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733618|NCT00116272|E4|Reported Event|Infants Etanercept Exposed|Infants born to pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733619|NCT00116272|E3|Reported Event|Infants Diseased Control|Infants born to pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733620|NCT00116272|E2|Reported Event|Mothers Etanercept Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
733621|NCT00116272|E1|Reported Event|Mothers Diseased Control|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
733622|NCT00116207|B3|Baseline|Total|Total of all reporting groups
733623|NCT00116207|B2|Baseline|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733624|NCT00116207|B1|Baseline|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733625|NCT00116207|P2|Participant Flow|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733626|NCT00116207|P1|Participant Flow|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733627|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733628|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733629|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733630|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733631|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733632|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733633|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733634|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733635|NCT00116207|E2|Reported Event|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733700|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733636|NCT00116207|E1|Reported Event|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
733637|NCT00116168|B5|Baseline|Total|Total of all reporting groups
733638|NCT00116168|B4|Baseline|MEDI-528 9 mg|
733639|NCT00116168|B3|Baseline|MEDI-528 3 mg|
733640|NCT00116168|B2|Baseline|MEDI-528 1 mg|
733641|NCT00116168|B1|Baseline|MEDI-528 0.3 mg|
733642|NCT00116168|P4|Participant Flow|MEDI-528 9 mg|
733643|NCT00116168|P3|Participant Flow|MEDI-528 3 mg|
733644|NCT00116168|P2|Participant Flow|MEDI-528 1 mg|
733645|NCT00116168|P1|Participant Flow|MEDI-528 0.3 mg|
733646|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733647|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733648|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733649|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733650|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733651|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733652|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733653|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733654|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733655|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733656|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733657|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733658|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733659|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733660|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733661|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733662|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733663|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733664|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733665|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733666|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733667|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733668|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733669|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733670|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733671|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733672|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733673|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733674|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733675|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733676|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733677|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733678|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733679|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733680|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733681|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733682|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733683|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733684|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733685|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733686|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733687|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733688|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733689|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733690|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733691|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733692|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733693|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733694|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
733695|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
733696|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
733697|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733769|NCT00115765|B5|Baseline|Total|Total of all reporting groups
733701|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
733702|NCT00116168|E4|Reported Event|MEDI-528 9 mg|
733703|NCT00116168|E3|Reported Event|MEDI-528 3 mg|
733704|NCT00116168|E2|Reported Event|MEDI-528 1 mg|
733705|NCT00116168|E1|Reported Event|MEDI-528 0.3 mg|
733706|NCT00115934|B3|Baseline|Total|Total of all reporting groups
733707|NCT00115934|B2|Baseline|RVPAS|Right ventricular to pulmonary artery shunt
733708|NCT00115934|B1|Baseline|MBTS|Blalock-Taussig pulmonary artery shunt
733709|NCT00115934|P2|Participant Flow|RVPAS|Right ventricular to pulmonary artery shunt
733710|NCT00115934|P1|Participant Flow|MBTS|Blalock-Taussig pulmonary artery shunt
733711|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733712|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733713|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733714|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733715|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733716|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733717|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733718|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733719|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733720|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733721|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733722|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733723|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733724|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733725|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733726|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733727|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733728|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733729|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733730|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733731|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733732|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733733|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733734|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733735|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733736|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733737|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733738|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733739|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733740|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733741|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733742|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733743|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
733744|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
733745|NCT00115934|E2|Reported Event|RVPAS|Right ventricular to pulmonary artery shunt
733746|NCT00115934|E1|Reported Event|MBTS|Blalock-Taussig pulmonary artery shunt
733747|NCT00115869|B3|Baseline|Total|Total of all reporting groups
733748|NCT00115869|B2|Baseline|Social Influences School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
733749|NCT00115869|B1|Baseline|No-intervention Control|No-intervention control group
733750|NCT00115869|P2|Participant Flow|Grade 3-12 School-based Intervention|Grade 3-12 school-influences school-based smoking prevention intervention
733751|NCT00115869|P1|Participant Flow|No-intervention Control|No-intervention control group
733752|NCT00115869|O2|Outcome|School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
733753|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control group
733754|NCT00115869|O2|Outcome|Social Influences School-based Smoking Prevention Curriculum|School-based social-influences smoking prevention curriculum condition
733755|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control condition
733756|NCT00115869|E2|Reported Event|School-based Smoking Prevention Curriculum Group|school-based smoking prevention curriculum
733757|NCT00115869|E1|Reported Event|No-intervention Control Group|no-intervention control
733758|NCT00115804|B1|Baseline|Fluoxetine|All eligible patients were given fluoxetine
733759|NCT00115804|P1|Participant Flow|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
733760|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
733761|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
733762|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
733763|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
733764|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
733765|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
733766|NCT00115804|O1|Outcome|Fluoxetine|"All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily.~Fluoxetine: fluoxetine po 10-60 mg/day for 12 weeks~Fluoxetine: Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily."
733767|NCT00115804|O1|Outcome|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
733768|NCT00115804|E1|Reported Event|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
733770|NCT00115765|B4|Baseline|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733771|NCT00115765|B3|Baseline|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733772|NCT00115765|B2|Baseline|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733773|NCT00115765|B1|Baseline|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733774|NCT00115765|P4|Participant Flow|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733775|NCT00115765|P3|Participant Flow|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733776|NCT00115765|P2|Participant Flow|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733777|NCT00115765|P1|Participant Flow|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733778|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733779|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733780|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733781|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733782|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733783|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733784|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733785|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733786|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733787|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733788|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733789|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733790|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733791|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733792|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733793|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733794|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733795|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733796|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733797|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733798|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733799|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733800|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
733801|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733802|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733803|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733804|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733805|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733806|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733807|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733808|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733809|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733810|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
733811|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
733812|NCT00115765|E2|Reported Event|Bevacizumab With Chemotherapy|
733813|NCT00115765|E1|Reported Event|Panit. Plus Bevacizumab With Chemotherapy|
733814|NCT00115739|B1|Baseline|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
733815|NCT00115739|P1|Participant Flow|Imatinib (Gleevec) Tablets|4 (100 mg tablets) = 400 mg dose twice per day (morning and evening) for 16 weeks
733816|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
734814|NCT00112437|P3|Participant Flow|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
733817|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
733818|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|
733819|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|Subjects were administered oral Gleevec tablets, then tumor response was assessed
733820|NCT00115739|E1|Reported Event|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
733821|NCT00115349|B3|Baseline|Total|Total of all reporting groups
733822|NCT00115349|B2|Baseline|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
733823|NCT00115349|B1|Baseline|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
733824|NCT00115349|P2|Participant Flow|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
733825|NCT00115349|P1|Participant Flow|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
733826|NCT00115349|O2|Outcome|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
733827|NCT00115349|O1|Outcome|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
733828|NCT00115349|E2|Reported Event|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
733829|NCT00115349|E1|Reported Event|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
733830|NCT00115297|B3|Baseline|Total|Total of all reporting groups
733831|NCT00115297|B2|Baseline|Placebo|"Placebo (placebo tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old received placebo montelukast granules."
733832|NCT00115297|B1|Baseline|Montelukast|"5-mg montelukast tablets or 4 mg granules~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules."
733833|NCT00115297|P2|Participant Flow|Placebo|"Placebo (montelukast tablet or montelukast granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
733834|NCT00115297|P1|Participant Flow|Monteluksat|"5-mg montelukast tablets or 4 mg granules)~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old will receive 4-mg montelukast granules."
733835|NCT00115297|O2|Outcome|Placebo|"Placebo (tablets or granules)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
733836|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
733837|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
733838|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
733839|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
733840|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
733841|NCT00115297|E2|Reported Event|Placebo|"Placebo (tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
733842|NCT00115297|E1|Reported Event|Montelukast|"Montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
733843|NCT00115063|B3|Baseline|Total|Total of all reporting groups
733844|NCT00115063|B2|Baseline|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733845|NCT00115063|B1|Baseline|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733846|NCT00115063|P2|Participant Flow|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733847|NCT00115063|P1|Participant Flow|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733848|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733849|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733850|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733851|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733852|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733853|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733854|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733855|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733856|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733857|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733858|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733859|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733860|NCT00115063|E2|Reported Event|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
733861|NCT00115063|E1|Reported Event|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
733862|NCT00114972|B3|Baseline|Total|Total of all reporting groups
733863|NCT00114972|B2|Baseline|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733864|NCT00114972|B1|Baseline|CABG|Coronary Artery By-pass Graft (CABG)
733865|NCT00114972|P2|Participant Flow|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733866|NCT00114972|P1|Participant Flow|CABG|Coronary Artery By-pass Graft (CABG)
733867|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733868|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733869|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733870|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733871|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733872|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733873|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733874|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733875|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733876|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733877|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733878|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733879|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733880|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733881|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733882|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
733883|NCT00114972|E2|Reported Event|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
733884|NCT00114972|E1|Reported Event|CABG|Coronary Artery By-pass Graft (CABG)
733885|NCT00114959|B1|Baseline|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
733886|NCT00114959|P1|Participant Flow|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
733887|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
733888|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
733889|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
733914|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733890|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
733891|NCT00114959|E1|Reported Event|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
733892|NCT00114777|B4|Baseline|Total|Total of all reporting groups
733893|NCT00114777|B3|Baseline|Cyclosporin A (CsA)|Cyclosporine A 410 mg/kg was capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733894|NCT00114777|B2|Baseline|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733895|NCT00114777|B1|Baseline|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733896|NCT00114777|P3|Participant Flow|Cyclosporin A (CsA)|Cyclosporin A 4-10 mg/kg capsules orally in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.
733897|NCT00114777|P2|Participant Flow|Belatacept Less Intensive (LI) Regimen|Belatacept 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.
733898|NCT00114777|P1|Participant Flow|Belatacept More Intensive (MI) Regimen|Belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months
733899|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733900|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733901|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733902|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733903|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733904|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733905|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733906|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733907|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733908|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733909|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733910|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733911|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733912|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733913|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733915|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733916|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733917|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733918|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733919|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733920|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733921|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733922|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733923|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733924|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733925|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733926|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733927|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733928|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733929|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733930|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733931|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733932|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733933|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84months.
733934|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733935|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733936|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733937|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733938|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733939|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733940|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733941|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733942|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733943|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733944|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733945|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733946|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733947|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733948|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733949|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733950|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733951|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733952|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733953|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733954|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733955|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733956|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733957|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733958|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733959|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733960|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733961|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733962|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733963|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733964|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733965|NCT00114777|O3|Outcome|Cyclosporin A (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733966|NCT00114777|O2|Outcome|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733967|NCT00114777|O1|Outcome|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
734815|NCT00112437|P2|Participant Flow|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
733968|NCT00114777|E3|Reported Event|Cyclosporin (CsA)|Cyclosporin A 410 mg/kg capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
733969|NCT00114777|E2|Reported Event|Belatacept Less Intensive (LI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
733970|NCT00114777|E1|Reported Event|Belatacept More Intensive (MI) Regimen|Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
733971|NCT00114634|B1|Baseline|Egg Yolk or no Egg Yolk|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
733972|NCT00114634|P1|Participant Flow|Egg Yolk or no Egg Yolk|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
733973|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
733974|NCT00114634|O1|Outcome|Placebo|egg substitute
733975|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
733976|NCT00114634|O1|Outcome|Placebo|egg substitute
733977|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
733978|NCT00114634|O1|Outcome|Placebo|egg substitute
733979|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
733980|NCT00114634|O1|Outcome|Placebo|egg substitute
733981|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
733982|NCT00114634|O1|Outcome|Placebo|egg substitute
733983|NCT00114634|O1|Outcome|Crossover Study|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
733984|NCT00114634|E1|Reported Event|Group 1|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
733985|NCT00114530|B3|Baseline|Total|Total of all reporting groups
733986|NCT00114530|B2|Baseline|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
733987|NCT00114530|B1|Baseline|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
733988|NCT00114530|P2|Participant Flow|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
733989|NCT00114530|P1|Participant Flow|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
733990|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
733991|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
733992|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
733993|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734009|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
733994|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
733995|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
733996|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
733997|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
733998|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
733999|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734000|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734001|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734002|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734003|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734004|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734005|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734006|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734007|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734008|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734098|NCT00114517|P4|Participant Flow|Late Postmenopause Placebo|Late postmenopause >10 years-since-menopause
734010|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734011|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734012|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734013|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734014|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734015|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734016|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734017|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734018|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734019|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734020|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734021|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734022|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734023|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734024|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734025|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734026|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734027|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734028|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734029|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734030|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734031|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734099|NCT00114517|P3|Participant Flow|Late Postmenopause 17B-estradiol|Late postmenopause >10 years-since-menopause oral 17B-estradiol 1 mg daily
734032|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734033|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734034|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734035|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734036|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734037|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734038|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734039|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734040|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734041|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734042|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734043|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734044|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734045|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734046|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734047|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734048|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734049|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734050|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734051|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734052|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734053|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734054|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734055|NCT00114530|O4|Outcome|Cyclophosphamide- EFS Failure|Subjects in the Cyclophosphamide group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734056|NCT00114530|O3|Outcome|mHSCT- EFS Failure|Subjects in the mHSCT group who failed the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734057|NCT00114530|O2|Outcome|Cyclophosphamide-EFS Survivor|Subjects in the Cyclophosphamide group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734058|NCT00114530|O1|Outcome|mHSCT- EFS Survivor|Subjects in the mHSCT group who met the event-free survival (EFS) endpoint, defined as survival without significant organ damage or death.
734059|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734060|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734061|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734077|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734100|NCT00114517|P2|Participant Flow|Early Postmenopause Placebo|Early postmenopause <6 years-since-menopause
734101|NCT00114517|P1|Participant Flow|Early Postmenopause 17B-estradiol|Early postmenopause, <6 years-since-menopause oral 17B-estradiol 1 mg daily
734062|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734063|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734064|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734065|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734066|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734067|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734068|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734069|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734070|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734071|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734072|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734073|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734074|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734075|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734076|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734095|NCT00114517|B3|Baseline|Late Postmenopause 17B-estradiol|
734096|NCT00114517|B2|Baseline|Early Postmenopause Placebo|
734078|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734079|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734080|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734081|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734082|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734083|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734084|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734085|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734086|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734087|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734088|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734089|NCT00114530|O2|Outcome|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734090|NCT00114530|O1|Outcome|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734091|NCT00114530|E2|Reported Event|Cyclophosphamide|Participants received 12 monthly pulses of high-dose intravenous cyclophosphamide (an initial dose of 500 mg/m^2, followed by 11 doses of 750 mg/m^2).
734092|NCT00114530|E1|Reported Event|mHSCT|Participants were administered granulocyte colony stimulating factor (G-CSF) and had hematopoietic stem cells removed from their blood. They then underwent high-dose immunosuppressive therapy using a conditioning regimen of total body irradiation (800 cGy given over 2 days with lung and kidney shielding limiting exposure to 200cGy), cyclophosphamide (60 mg/kg/day for 2 days), IV Methylprednisolone (1 mg/kg/day for 3 days), and equine antithymocyte globulin (ATGAM) (15 mg/kg/day for 3 days). Purified autologous stem cell were infused at a dose of >2.5x106 CD34+ cells/kg. After transplantation, participants received additional doses of IV Methylprednisolone (1 mg/kg/day for 3 days) and ATGAM (15 mg/kg/day for 3 days.)
734093|NCT00114517|B5|Baseline|Total|Total of all reporting groups
734094|NCT00114517|B4|Baseline|Late Postmenopause Placebo|
734102|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
734103|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
734104|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
734105|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
734106|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
734107|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
734108|NCT00114517|E2|Reported Event|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
734109|NCT00114517|E1|Reported Event|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
734110|NCT00114504|B3|Baseline|Total|Total of all reporting groups
734111|NCT00114504|B2|Baseline|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
734112|NCT00114504|B1|Baseline|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
734113|NCT00114504|P2|Participant Flow|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
734114|NCT00114504|P1|Participant Flow|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
734115|NCT00114504|O4|Outcome|Control Group at 3 Months|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
734116|NCT00114504|O3|Outcome|Control Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline
734117|NCT00114504|O2|Outcome|Simvastatin Group at 3 Month|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
734118|NCT00114504|O1|Outcome|Simvastatin Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy at baseline
734119|NCT00114504|O2|Outcome|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months
734120|NCT00114504|O1|Outcome|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
734121|NCT00114504|E2|Reported Event|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
734122|NCT00114504|E1|Reported Event|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
734123|NCT00114244|B3|Baseline|Total|Total of all reporting groups
734124|NCT00114244|B2|Baseline|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
734125|NCT00114244|B1|Baseline|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
734126|NCT00114244|P2|Participant Flow|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
734127|NCT00114244|P1|Participant Flow|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
734128|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
734129|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
734130|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
734131|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
734132|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
734133|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
734134|NCT00114244|E2|Reported Event|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
734135|NCT00114244|E1|Reported Event|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
734136|NCT00114231|B3|Baseline|Total|Total of all reporting groups
734148|NCT00114166|B1|Baseline|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
734304|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
734137|NCT00114231|B2|Baseline|Revised Dose Group|The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
734138|NCT00114231|B1|Baseline|Original Dose Group|External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3–4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1–14 and 22–35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
734139|NCT00114231|P2|Participant Flow|Revised Dose Group|The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
734140|NCT00114231|P1|Participant Flow|Original Dose Group|External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3–4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1–14 and 22–35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
734141|NCT00114231|O1|Outcome|Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)|Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
734142|NCT00114231|O1|Outcome|Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)|Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
734143|NCT00114231|O1|Outcome|Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)|Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
734144|NCT00114231|O1|Outcome|Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)|Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
734145|NCT00114231|O1|Outcome|Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery)|Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
734146|NCT00114231|E2|Reported Event|Revised Dose Group|The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
734147|NCT00114231|E1|Reported Event|Original Dose Group|External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3–4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1–14 and 22–35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
734149|NCT00114166|P1|Participant Flow|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
734150|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
734151|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
734152|NCT00114166|E2|Reported Event|Regimen II|Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
734153|NCT00114166|E1|Reported Event|Regimen I|Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
734154|NCT00114140|B1|Baseline|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734155|NCT00114140|P1|Participant Flow|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734156|NCT00114140|O2|Outcome|Temozolomide + Radiation Therapy (RT) at 12 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734157|NCT00114140|O1|Outcome|Temozolomide + Radiation Therapy (RT) at 6 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734158|NCT00114140|O3|Outcome|Temozolomide + Radiation Therapy (RT) at 12 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734159|NCT00114140|O2|Outcome|Temozolomide + Radiation Therapy (RT) at 6 Months|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734160|NCT00114140|O1|Outcome|Temozolomide + Radiation Therapy (RT) at Baseline|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734161|NCT00114140|O2|Outcome|Temozolomide + Radiation Therapy (RT) - Unmethylated|Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with unmethylated status
734162|NCT00114140|O1|Outcome|Temozolomide + Radiation Therapy (RT) - Methylated|Daily temozolomide plus concurrent radiotherapy followed by temozolomide - Patients with methylated status
734163|NCT00114140|O1|Outcome|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734164|NCT00114140|O1|Outcome|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734165|NCT00114140|E1|Reported Event|Temozolomide + Radiation Therapy (RT)|Daily temozolomide plus concurrent radiotherapy followed by temozolomide
734166|NCT00114127|B3|Baseline|Total|Total of all reporting groups
734167|NCT00114127|B2|Baseline|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
734168|NCT00114127|B1|Baseline|Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
734169|NCT00114127|P2|Participant Flow|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
734170|NCT00114127|P1|Participant Flow|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
734171|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
734172|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
734173|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
734174|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
734175|NCT00114127|E2|Reported Event|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
734176|NCT00114127|E1|Reported Event|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
734177|NCT00114101|B3|Baseline|Total|Total of all reporting groups
734178|NCT00114101|B2|Baseline|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
734179|NCT00114101|B1|Baseline|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
734180|NCT00114101|P2|Participant Flow|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
734181|NCT00114101|P1|Participant Flow|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
734182|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
734183|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
734184|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
734185|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
734186|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily.~(closed as of 12/17/09)"
734187|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily.
734188|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
734189|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
734190|NCT00114101|E2|Reported Event|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
734191|NCT00114101|E1|Reported Event|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
734192|NCT00113919|B1|Baseline|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
734193|NCT00113919|P1|Participant Flow|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
734194|NCT00113919|O1|Outcome|Busulfex|
734195|NCT00113919|E1|Reported Event|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
734196|NCT00113880|B4|Baseline|Total|Total of all reporting groups
734197|NCT00113880|B3|Baseline|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734198|NCT00113880|B2|Baseline|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734199|NCT00113880|B1|Baseline|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734200|NCT00113880|P3|Participant Flow|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734201|NCT00113880|P2|Participant Flow|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734202|NCT00113880|P1|Participant Flow|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734203|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
734204|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
734205|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
734206|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
734207|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
734208|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
734209|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734210|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734211|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734212|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734213|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734214|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734215|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734216|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734217|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734218|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734219|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734220|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734221|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734222|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734223|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
747674|NCT00075803|E2|Reported Event|Voriconazole|voriconazole prophylaxis
734224|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734225|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734226|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734227|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734228|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734229|NCT00113880|O3|Outcome|Unvaccinated Controls|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734230|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734231|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734232|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734233|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734234|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734235|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734236|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734237|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734238|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734277|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734239|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734240|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734241|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734242|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734243|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734244|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734245|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734246|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734247|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734248|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734249|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734250|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734251|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734252|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734301|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734302|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
734816|NCT00112437|P1|Participant Flow|Placebo-Base|One placebo tablet once a week
734253|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
734254|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
734255|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
734256|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
734257|NCT00113880|E1|Reported Event|FluMist Recipients|
734258|NCT00113841|B3|Baseline|Total|Total of all reporting groups
734259|NCT00113841|B2|Baseline|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
734260|NCT00113841|B1|Baseline|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
734261|NCT00113841|P2|Participant Flow|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
734262|NCT00113841|P1|Participant Flow|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
734263|NCT00113841|O2|Outcome|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
734264|NCT00113841|O1|Outcome|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
734265|NCT00113841|E2|Reported Event|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
734266|NCT00113841|E1|Reported Event|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
734267|NCT00113763|B3|Baseline|Total|Total of all reporting groups
734268|NCT00113763|B2|Baseline|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734269|NCT00113763|B1|Baseline|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734270|NCT00113763|P2|Participant Flow|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734271|NCT00113763|P1|Participant Flow|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734272|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734273|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734274|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734275|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734276|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734303|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734278|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734279|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734280|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734281|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734282|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734283|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734284|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734285|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734286|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734287|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734288|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734289|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734290|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734291|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734292|NCT00113763|E2|Reported Event|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
734293|NCT00113763|E1|Reported Event|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
734294|NCT00113607|B3|Baseline|Total|Total of all reporting groups
734295|NCT00113607|B2|Baseline|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734296|NCT00113607|B1|Baseline|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
734297|NCT00113607|P2|Participant Flow|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734298|NCT00113607|P1|Participant Flow|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
734299|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734300|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734305|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734306|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
734307|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734308|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
734309|NCT00113607|E2|Reported Event|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
734310|NCT00113607|E1|Reported Event|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
734311|NCT00113568|B1|Baseline|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734312|NCT00113568|P1|Participant Flow|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734313|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734314|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734315|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734316|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734317|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734318|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734319|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734320|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734321|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734322|NCT00113568|E1|Reported Event|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
734323|NCT00113529|B1|Baseline|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734324|NCT00113529|P1|Participant Flow|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 milligrams (mg) or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734325|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734326|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734327|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734328|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734403|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734404|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734329|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734330|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734331|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734332|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734333|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734334|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734335|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734336|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734337|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734338|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734339|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734340|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734405|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734341|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734342|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734343|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734344|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734345|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734346|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734347|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734348|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734349|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734350|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734351|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734352|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734406|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734353|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734354|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734355|NCT00113529|E1|Reported Event|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
734356|NCT00113516|B1|Baseline|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734357|NCT00113516|P2|Participant Flow|Sunitinib|Sunitinib 50 mg
734358|NCT00113516|P1|Participant Flow|Carboplatin Plus Paclitaxel|Carboplatin Plus Paclitaxel 172-225 mg/m2
734359|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734360|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734361|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734362|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734363|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734364|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734365|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734366|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734367|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734368|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734369|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734370|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734371|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734372|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734373|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734374|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734375|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734376|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734377|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734378|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734379|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734380|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734381|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734382|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734383|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734384|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734385|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734386|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734387|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734388|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734389|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
734390|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734391|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734392|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734393|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734394|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734395|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
734396|NCT00113516|E2|Reported Event|Sunitinib 50 mg (Part 2)|
734397|NCT00113516|E1|Reported Event|Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1)|
734398|NCT00113490|B3|Baseline|Total|Total of all reporting groups
734399|NCT00113490|B2|Baseline|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734400|NCT00113490|B1|Baseline|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734401|NCT00113490|P2|Participant Flow|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734402|NCT00113490|P1|Participant Flow|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
735009|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
734407|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734408|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734409|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734410|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734411|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734412|NCT00113490|E2|Reported Event|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734413|NCT00113490|E1|Reported Event|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
734414|NCT00113425|B1|Baseline|Treated Group Pulsed Dye Laser Therapy and Untreated Group|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control.
734415|NCT00113425|P1|Participant Flow|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734416|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734417|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734418|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734419|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734420|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734421|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734422|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734423|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734424|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734425|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734426|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734427|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734428|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734429|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
734430|NCT00113425|E2|Reported Event|Untreated Group Control|The contralateral side of the face remained untreated, thus serving as an internal control.
734431|NCT00113425|E1|Reported Event|Treated Group Pulsed Dye Laser Therapy|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face.
734432|NCT00113399|B3|Baseline|Total|Total of all reporting groups
734433|NCT00113399|B2|Baseline|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with on-study information, which is 7 patients.]"
734434|NCT00113399|B1|Baseline|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with on-study information, which is 6 patients.]
734500|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734435|NCT00113399|P2|Participant Flow|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
734436|NCT00113399|P1|Participant Flow|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
734437|NCT00113399|O2|Outcome|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel"
734438|NCT00113399|O1|Outcome|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8
734439|NCT00113399|E2|Reported Event|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
734440|NCT00113399|E1|Reported Event|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
734441|NCT00113386|B3|Baseline|Total|Total of all reporting groups
734442|NCT00113386|B2|Baseline|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with on-study information, which is 7 patients.]
734443|NCT00113386|B1|Baseline|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery [Data is reported for eligible patients with on-study information, which is 8 patients.]
734444|NCT00113386|P2|Participant Flow|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative (induction) throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
734445|NCT00113386|P1|Participant Flow|Preoperative Cisplatin/Docetaxel|Preoperative (induction) cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
734446|NCT00113386|O2|Outcome|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
734447|NCT00113386|O1|Outcome|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
734448|NCT00113386|E2|Reported Event|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 7 patients.]
734449|NCT00113386|E1|Reported Event|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 9 patients.]
734450|NCT00113373|B1|Baseline|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
734451|NCT00113373|P1|Participant Flow|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
734452|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
734453|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
734454|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
734455|NCT00113373|E1|Reported Event|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
734456|NCT00113360|B1|Baseline|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
734457|NCT00113360|P1|Participant Flow|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
734458|NCT00113360|O1|Outcome|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
734459|NCT00113360|E1|Reported Event|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
734460|NCT00113334|B1|Baseline|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
734461|NCT00113334|P1|Participant Flow|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
734462|NCT00113334|O1|Outcome|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
734463|NCT00113334|E1|Reported Event|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
734464|NCT00113321|B1|Baseline|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
734465|NCT00113321|P1|Participant Flow|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
734466|NCT00113321|O1|Outcome|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
734467|NCT00113321|E1|Reported Event|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
734468|NCT00113295|B3|Baseline|Total|Total of all reporting groups
734469|NCT00113295|B2|Baseline|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
735010|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
734470|NCT00113295|B1|Baseline|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
734471|NCT00113295|P2|Participant Flow|Placebo Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
734472|NCT00113295|P1|Participant Flow|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
734473|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
734474|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
734475|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
734476|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
734477|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
734478|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
734479|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
734480|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
734481|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
734482|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
734483|NCT00113295|E3|Reported Event|Paroxetine|Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8.
734484|NCT00113295|E2|Reported Event|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
734485|NCT00113295|E1|Reported Event|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
734486|NCT00113269|B5|Baseline|Total|Total of all reporting groups
734487|NCT00113269|B4|Baseline|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734488|NCT00113269|B3|Baseline|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734489|NCT00113269|B2|Baseline|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734490|NCT00113269|B1|Baseline|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734491|NCT00113269|P4|Participant Flow|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734492|NCT00113269|P3|Participant Flow|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734493|NCT00113269|P2|Participant Flow|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734494|NCT00113269|P1|Participant Flow|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734495|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734496|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734497|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734498|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734499|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
747675|NCT00075803|E1|Reported Event|Fluconazole|fluconazole prophylaxis
734501|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734502|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734503|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734504|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734505|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734506|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734507|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734508|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734509|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734510|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734511|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734512|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734513|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734514|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734515|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734516|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734517|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734518|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734519|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734520|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734521|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734522|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734523|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734524|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734525|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734526|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734527|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734528|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734529|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734530|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734531|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734532|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
747676|NCT00075764|B3|Baseline|Total|Total of all reporting groups
734533|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734534|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734535|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734536|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734537|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734538|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734539|NCT00113269|E4|Reported Event|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734540|NCT00113269|E3|Reported Event|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
734541|NCT00113269|E2|Reported Event|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734542|NCT00113269|E1|Reported Event|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
734543|NCT00113230|B1|Baseline|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
734544|NCT00113230|P1|Participant Flow|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
734545|NCT00113230|O1|Outcome|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
734546|NCT00113230|E1|Reported Event|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
734547|NCT00113217|B1|Baseline|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
734548|NCT00113217|P1|Participant Flow|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
734549|NCT00113217|O1|Outcome|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
734550|NCT00113217|E1|Reported Event|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
734551|NCT00113087|B3|Baseline|Total|Total of all reporting groups
734552|NCT00113087|B2|Baseline|Placebo|Placebo suspension
734553|NCT00113087|B1|Baseline|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734554|NCT00113087|P2|Participant Flow|Placebo|Placebo suspension
734555|NCT00113087|P1|Participant Flow|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734556|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734557|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734558|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734559|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734560|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734561|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734562|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734563|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734564|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734565|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734566|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734567|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734568|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734569|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734570|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734571|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734572|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734573|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734574|NCT00113087|O2|Outcome|Placebo|Placebo suspension
749365|NCT00067990|O2|Outcome|Placebo|within 3 months of transplantation
734575|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734576|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734577|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734578|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734579|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734580|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734581|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734582|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734583|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734584|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734585|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734586|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734587|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734588|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734589|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734590|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734591|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734592|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734593|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734594|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734595|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734596|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734597|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734598|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734599|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734600|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734601|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734602|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734603|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734604|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734605|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734606|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734607|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734608|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734609|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734610|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734611|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734612|NCT00113087|O2|Outcome|Placebo|Placebo suspension
734613|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734614|NCT00113087|E2|Reported Event|Placebo|Placebo suspension
734615|NCT00113087|E1|Reported Event|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
734616|NCT00113022|B3|Baseline|Total|Total of all reporting groups
734617|NCT00113022|B2|Baseline|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
734618|NCT00113022|B1|Baseline|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
735011|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
734619|NCT00113022|P2|Participant Flow|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
734620|NCT00113022|P1|Participant Flow|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
734621|NCT00113022|O2|Outcome|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
734622|NCT00113022|O1|Outcome|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
734623|NCT00113022|E2|Reported Event|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
734624|NCT00113022|E1|Reported Event|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
734625|NCT00112957|B1|Baseline|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734626|NCT00112957|P1|Participant Flow|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734627|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734628|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734629|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734630|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734631|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734632|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734633|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734634|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734635|NCT00112957|O1|Outcome|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734636|NCT00112957|E1|Reported Event|rV- and rF-NY-ESO-1|Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
734637|NCT00112918|B4|Baseline|Total|Total of all reporting groups
735012|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735013|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
734638|NCT00112918|B3|Baseline|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734639|NCT00112918|B2|Baseline|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734640|NCT00112918|B1|Baseline|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734641|NCT00112918|P3|Participant Flow|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734642|NCT00112918|P2|Participant Flow|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734643|NCT00112918|P1|Participant Flow|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734644|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734645|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734646|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734647|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734648|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734649|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734650|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734651|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734652|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734653|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734654|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734655|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734656|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734657|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
735014|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
734658|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734659|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734660|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734661|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734662|NCT00112918|E3|Reported Event|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734663|NCT00112918|E2|Reported Event|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
734664|NCT00112918|E1|Reported Event|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
734665|NCT00112905|B1|Baseline|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
734666|NCT00112905|P1|Participant Flow|TCC (Transitional Cell Carcinoma) Cohort|Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.
734667|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
734668|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
735015|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735016|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
734669|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
734670|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
734671|NCT00112905|E1|Reported Event|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
734672|NCT00112866|B3|Baseline|Total|Total of all reporting groups
734673|NCT00112866|B2|Baseline|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose 2000mg cilengitide IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734674|NCT00112866|B1|Baseline|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose 500mg cilengitide IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734675|NCT00112866|P2|Participant Flow|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose cilengitide 2000mg IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734676|NCT00112866|P1|Participant Flow|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose cilengitide 500mg IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide 2000mg IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734677|NCT00112866|O1|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734678|NCT00112866|O2|Outcome|Group II (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734679|NCT00112866|O1|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734680|NCT00112866|O2|Outcome|Group II High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734681|NCT00112866|O1|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive 2000mg high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734682|NCT00112866|O2|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
734683|NCT00112866|O1|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
734684|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
734685|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
734686|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
734687|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
734688|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
734689|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
734690|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
734691|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
734692|NCT00112866|O1|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~pharmacological study: Correlative studies"
734693|NCT00112866|E1|Reported Event|Post-Operative 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
734694|NCT00112840|B4|Baseline|Total|Total of all reporting groups
734695|NCT00112840|B3|Baseline|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734696|NCT00112840|B2|Baseline|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734697|NCT00112840|B1|Baseline|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734698|NCT00112840|P3|Participant Flow|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734699|NCT00112840|P2|Participant Flow|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734700|NCT00112840|P1|Participant Flow|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734701|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734702|NCT00112840|O2|Outcome|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734703|NCT00112840|O1|Outcome|Phase 1, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734704|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734705|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734706|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734707|NCT00112840|O2|Outcome|Phase 1, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734708|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and escalating doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734709|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734710|NCT00112840|O2|Outcome|Phase 1 , Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734711|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734712|NCT00112840|E3|Reported Event|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
734713|NCT00112840|E2|Reported Event|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
735017|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
734714|NCT00112840|E1|Reported Event|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
734715|NCT00112736|B4|Baseline|Total|Total of all reporting groups
734716|NCT00112736|B3|Baseline|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
734717|NCT00112736|B2|Baseline|Phase II n=16|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Anaplastic Glioma~erlotinib: Given orally~temsirolimus: Given IV"
734718|NCT00112736|B1|Baseline|Phase I n=9|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
734719|NCT00112736|P2|Participant Flow|Phase II (Erlotinib & Temsirolimus)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
734720|NCT00112736|P1|Participant Flow|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
734721|NCT00112736|O1|Outcome|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
734722|NCT00112736|O3|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
734723|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
734724|NCT00112736|O1|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
734725|NCT00112736|O1|Outcome|Phase I 15mg Temsirolimus (MTD Dose)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
734726|NCT00112736|O3|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
734727|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
734728|NCT00112736|O1|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
734729|NCT00112736|O1|Outcome|Phase I - Dose Escalation|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity.~Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts"
734730|NCT00112736|E2|Reported Event|Phase II (Erlotinib & Erlotinib)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
734731|NCT00112736|E1|Reported Event|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
734732|NCT00112723|B1|Baseline|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
734733|NCT00112723|P3|Participant Flow|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
734734|NCT00112723|P2|Participant Flow|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
734735|NCT00112723|P1|Participant Flow|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
735018|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735019|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
734736|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
734737|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
734738|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
734739|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
734740|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
734741|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
734742|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
734743|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
734744|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
734745|NCT00112723|O3|Outcome|Cohort 4|Patients diagnosed with T Cell NHL
734746|NCT00112723|O2|Outcome|Cohort 2|Patients diagnosed with Mantle Cell NHL
734747|NCT00112723|O1|Outcome|Cohort 1|Patients diagnosed with Indolent B-cell NHL
734748|NCT00112723|O1|Outcome|Dose Levels 1, 2, 3|"Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2)~PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
734749|NCT00112723|O3|Outcome|Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
734750|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
734751|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
734752|NCT00112723|O3|Outcome|Level 3 (50+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
734753|NCT00112723|O2|Outcome|Level 2 (30+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
734754|NCT00112723|O1|Outcome|Dose Level 1 (30+30)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
734755|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
734756|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
735020|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735021|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
749366|NCT00067990|O1|Outcome|Losartan|within 3 months of transplantation
734757|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
734758|NCT00112723|E1|Reported Event|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
734759|NCT00112671|B1|Baseline|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
734760|NCT00112671|P1|Participant Flow|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
734761|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
734762|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
734763|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
734764|NCT00112671|E1|Reported Event|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
734765|NCT00112593|B1|Baseline|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734766|NCT00112593|P1|Participant Flow|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734767|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734768|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734782|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
734783|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
735022|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
734769|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734770|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734771|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734772|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734773|NCT00112593|E1|Reported Event|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
734774|NCT00112489|B1|Baseline|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
734775|NCT00112489|P1|Participant Flow|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
734776|NCT00112489|O1|Outcome|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
734777|NCT00112489|E1|Reported Event|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
734778|NCT00112463|B1|Baseline|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
734779|NCT00112463|P1|Participant Flow|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
734780|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
734781|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|"Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.~romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting."
749367|NCT00067990|O2|Outcome|Placebo|within 3 months of transplantation
734784|NCT00112463|E1|Reported Event|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
734785|NCT00112437|B6|Baseline|Total|Total of all reporting groups
734786|NCT00112437|B5|Baseline|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
734787|NCT00112437|B4|Baseline|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
734788|NCT00112437|B3|Baseline|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
734789|NCT00112437|B2|Baseline|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
734790|NCT00112437|B1|Baseline|Placebo-Base|One placebo tablet once a week
734791|NCT00112437|P26|Participant Flow|Group D: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet once a week. Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
734792|NCT00112437|P25|Participant Flow|Group C: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group C consisted of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
734793|NCT00112437|P24|Participant Flow|Group B: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group B consisted of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
734794|NCT00112437|P23|Participant Flow|Group A: Odanacatib 50 mg Once Weekly-Ext 4|During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group A consisted of a combination of participants who were treated with odanacatib 25 mg for 2 years,then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
734795|NCT00112437|P22|Participant Flow|Odanacatib 50 mg Once Weekly-Ext 3|During this 24-month extension (Years 4-5), participants in this treatment group received one odanacatib 50 mg tablet once a week.
734796|NCT00112437|P21|Participant Flow|Placebo Once Weekly-Ext 3|During this 24-month extension (Years 4-5), participants in this treatment group received one placebo tablet once a week.
734797|NCT00112437|P20|Participant Flow|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734798|NCT00112437|P19|Participant Flow|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734799|NCT00112437|P18|Participant Flow|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734800|NCT00112437|P17|Participant Flow|Odanacatib 25 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734801|NCT00112437|P16|Participant Flow|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734802|NCT00112437|P15|Participant Flow|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734803|NCT00112437|P14|Participant Flow|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734804|NCT00112437|P13|Participant Flow|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734805|NCT00112437|P12|Participant Flow|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734806|NCT00112437|P11|Participant Flow|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734807|NCT00112437|P10|Participant Flow|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
734808|NCT00112437|P9|Participant Flow|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
734809|NCT00112437|P8|Participant Flow|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734810|NCT00112437|P7|Participant Flow|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
734811|NCT00112437|P6|Participant Flow|Placebo-Ext 1|One placebo tablet once a week
734812|NCT00112437|P5|Participant Flow|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
734817|NCT00112437|O4|Outcome|Group D: Odanacatib 50 mg Once Weekly|Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
734818|NCT00112437|O3|Outcome|Group C: Odanacatib 50 mg Once Weekly|Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
734819|NCT00112437|O2|Outcome|Group B: Odanacatib 50 mg Once Weekly|Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years
734820|NCT00112437|O1|Outcome|Group A: Odanacatib 50 mg Once Weekly|Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
734821|NCT00112437|O4|Outcome|Group D: Odanacatib 50 mg Once Weekly|Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
734822|NCT00112437|O3|Outcome|Group C: Odanacatib 50 mg Once Weekly|Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
734823|NCT00112437|O2|Outcome|Group B: Odanacatib 50 mg Once Weekly|Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
734824|NCT00112437|O1|Outcome|Group A: Odanacatib 50 mg Once Weekly|Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
734825|NCT00112437|O4|Outcome|Group D: Odanacatib 50 mg Once Weekly|Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
734826|NCT00112437|O3|Outcome|Group C: Odanacatib 50 mg Once Weekly|Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
734827|NCT00112437|O2|Outcome|Group B: Odanacatib 50 mg Once Weekly|Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
734828|NCT00112437|O1|Outcome|Group A: Odanacatib 50 mg Once Weekly|Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
734829|NCT00112437|O2|Outcome|Odanacatib 50 mg Once Weekly|One odanacatib 50 mg tablet once a week
734830|NCT00112437|O1|Outcome|Placebo Once Weekly|One placebo tablet once a week
734831|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734832|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734833|NCT00112437|O8|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734834|NCT00112437|O7|Outcome|Odanacatib 25 mg / Placebo 50 Mg-Ext 2|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year."
734835|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734836|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734837|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734838|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
735023|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735024|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
734839|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734840|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734841|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734842|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734843|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734844|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734845|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734846|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734847|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734848|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734849|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734850|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734851|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734852|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734853|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734854|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734855|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734856|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734857|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734858|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734859|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734860|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734861|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
735025|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
734862|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734863|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734864|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734865|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734866|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734867|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734868|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734869|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734870|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734871|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734872|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734873|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734874|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734875|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734876|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734877|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734878|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734879|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734880|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734881|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734882|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734883|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734884|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734885|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734886|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734887|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734888|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734889|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734890|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734891|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734892|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734893|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734894|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734895|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734896|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734897|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734898|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734899|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734900|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734901|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734902|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734903|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734904|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734905|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734906|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734907|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
749368|NCT00067990|O1|Outcome|Losartan|within 3 months of transplantation
734908|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734909|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734910|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734911|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734912|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734913|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734914|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734915|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734916|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734917|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734918|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734919|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734920|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734921|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734922|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734923|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734924|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734925|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734926|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734927|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734928|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734929|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734930|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
735026|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
734931|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734932|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734933|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734934|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734935|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734936|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734937|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734938|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734939|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734940|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734941|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734942|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734943|NCT00112437|O8|Outcome|Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734944|NCT00112437|O7|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734945|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734946|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734947|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734948|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734949|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734950|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734951|NCT00112437|O10|Outcome|Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734952|NCT00112437|O9|Outcome|Odanacatib 50 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
734953|NCT00112437|O8|Outcome|Odanacatib 25 mg / 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734954|NCT00112437|O7|Outcome|Odanacatib 25 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
734955|NCT00112437|O6|Outcome|Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
734956|NCT00112437|O5|Outcome|Odanacatib 10 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
734957|NCT00112437|O4|Outcome|Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734958|NCT00112437|O3|Outcome|Odanacatib 3 mg / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
734959|NCT00112437|O2|Outcome|Placebo / Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734960|NCT00112437|O1|Outcome|Placebo / Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
734961|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
734962|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
734963|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734964|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
734965|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
734966|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
734967|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
734968|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734969|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
734970|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
734971|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
734972|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
734973|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734974|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
734975|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
734976|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
734977|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
734978|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734979|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
734980|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
734981|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
734982|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
734983|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734984|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
734985|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
734986|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
734987|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
734988|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734989|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
734990|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
734991|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
734992|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
734993|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734994|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
734995|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
734996|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
734997|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
734998|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
734999|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
735000|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
735001|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
735002|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
735003|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
735004|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
735005|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
735006|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
735007|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
735008|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
735027|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735028|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735029|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735030|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735031|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
735032|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735033|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735034|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735035|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735036|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
735037|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735038|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735039|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735040|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735041|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
735042|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735043|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735044|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735045|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735046|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
735047|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735048|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735049|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735050|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735051|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
735052|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735053|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735054|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735055|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735056|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
735057|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735058|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735059|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735060|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735061|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
735062|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
735063|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
735064|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
735065|NCT00112437|O1|Outcome|Placebo-Ext 1|One placebo tablet once a week
735066|NCT00112437|O5|Outcome|Odanacatib 50 Mg-Base|One odanacatib 50 mg tablet once a week
735067|NCT00112437|O4|Outcome|Odanacatib 25 Mg-Base|One odanacatib 25 mg tablet once a week
735068|NCT00112437|O3|Outcome|Odanacatib 10 Mg-Base|One odanacatib 10 mg tablet once a week
735069|NCT00112437|O2|Outcome|Odanacatib 3 Mg-Base|One odanacatib 3 mg tablet once a week
735070|NCT00112437|O1|Outcome|Placebo-Base|One placebo tablet once a week
735071|NCT00112437|E22|Reported Event|Years 6-10 Group D: Odanacatib 50 mg Once Weekly|Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
735072|NCT00112437|E21|Reported Event|Years 6-10 Group C: Odanacatib 50 mg Once Weekly|Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years
735073|NCT00112437|E20|Reported Event|Years 6-10 Group B: Odanacatib 50 mg Once Weekly|Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
735074|NCT00112437|E19|Reported Event|Years 6-10 Group A: Odanacatib 50 mg Once Weekly|Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
735075|NCT00112437|E18|Reported Event|Years 4-5 Combined Group A.3: Placebo|Combined Group A.3 consists of participants who, during this 24-month extension (Years 4-5), received placebo once a week.
735076|NCT00112437|E17|Reported Event|Years 4-5 Combined Group A.2: Odanacatib 50 mg|Combined Group A.2 consists of participants who received placebo or odanacatib 3 mg in Years 1, 2 and 3. During this 24-month extension (Years 4-5), these participants received odanacatib 50 mg once a week.
735077|NCT00112437|E16|Reported Event|Years 4-5 Combined Group A.1: Odanacatib 50 mg|"Combined Group A.1 consists of participants who received odanacatib 50 mg once a week during Year 3.~During this 24-month extension (Years 4-5), these participants continued to receive odanacatib 50 mg once a week."
735078|NCT00112437|E15|Reported Event|Year 3 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
735079|NCT00112437|E14|Reported Event|Year 3 Odanacatib 50 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
735080|NCT00112437|E13|Reported Event|Year 3 Odanacatib 25 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
735081|NCT00112437|E12|Reported Event|Year 3 Odanacatib 25 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
735082|NCT00112437|E11|Reported Event|Year 3 Odanacatib 10 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
735083|NCT00112437|E10|Reported Event|Year 3 Odanacatib 10 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
735084|NCT00112437|E9|Reported Event|Year 3 Odanacatib 3 mg/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
735085|NCT00112437|E8|Reported Event|Year 3 Odanacatib 3 mg/Placebo-Ext 2|During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
735086|NCT00112437|E7|Reported Event|Year 3 Placebo/Odanacatib 50 Mg-Ext 2|During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
735087|NCT00112437|E6|Reported Event|Year 3 Placebo/Placebo-Ext 2|During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
735088|NCT00112437|E5|Reported Event|Years 1-2 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 1|One odanacatib 50 mg tablet once a week
735089|NCT00112437|E4|Reported Event|Years 1-2 Odanacatib 25 mg/Odanacatib 25 Mg-Ext 1|One odanacatib 25 mg tablet once a week
735090|NCT00112437|E3|Reported Event|Years 1-2 Odanacatib 10 mg/Odanacatib 10 Mg-Ext 1|One odanacatib 10 mg tablet once a week
735091|NCT00112437|E2|Reported Event|Years 1-2 Odanacatib 3 mg/Odanacatib 3 Mg-Ext 1|One odanacatib 3 mg tablet once a week
735092|NCT00112437|E1|Reported Event|Years 1-2 Placebo/Placebo-Ext 1|One placebo tablet once a week
735093|NCT00112385|B3|Baseline|Total|Total of all reporting groups
735094|NCT00112385|B2|Baseline|Placebo|Subjects will be given syringes containing placebo
735095|NCT00112385|B1|Baseline|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735096|NCT00112385|P2|Participant Flow|Placebo|Subjects will be given syringes containing placebo
735097|NCT00112385|P1|Participant Flow|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735098|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735099|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735100|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735101|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735102|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735103|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735104|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735105|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735106|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735107|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735108|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735109|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735110|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735111|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735112|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735113|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735114|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735115|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735116|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735117|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735118|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735119|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735120|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735121|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735122|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735123|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735124|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735125|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735126|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735127|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735128|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735129|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735130|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735131|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735132|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735133|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735134|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735135|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735136|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735137|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735138|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735139|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735140|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735141|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735142|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735143|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735144|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735145|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735146|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735147|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735148|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735149|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735150|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735151|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735152|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735153|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735154|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735155|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735156|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735157|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735158|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735159|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735160|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735161|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735162|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735163|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735164|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735165|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735166|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735167|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735168|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735169|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735170|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735171|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735172|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735173|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735174|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735175|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735176|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735177|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735178|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735179|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735180|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
735181|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735182|NCT00112385|E2|Reported Event|Placebo|Subjects will be given syringes containing placebo
735183|NCT00112385|E1|Reported Event|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
735184|NCT00112359|B3|Baseline|Total|Total of all reporting groups
735185|NCT00112359|B2|Baseline|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735186|NCT00112359|B1|Baseline|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735187|NCT00112359|P2|Participant Flow|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735188|NCT00112359|P1|Participant Flow|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735189|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735190|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735191|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735192|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735193|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735194|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735195|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735196|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735197|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735198|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735199|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735200|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735201|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735202|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735203|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735204|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735205|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735206|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735207|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735208|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735209|NCT00112359|E2|Reported Event|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
735210|NCT00112359|E1|Reported Event|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
735211|NCT00112294|B3|Baseline|Total|Total of all reporting groups
735212|NCT00112294|B2|Baseline|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735213|NCT00112294|B1|Baseline|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735214|NCT00112294|P2|Participant Flow|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735215|NCT00112294|P1|Participant Flow|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735216|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735217|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735218|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735219|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735220|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735221|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735222|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735223|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735265|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
735224|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735225|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735226|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735227|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735228|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735229|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735230|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735231|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735232|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735233|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735234|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735235|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735236|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735237|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735238|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735239|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735266|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
750913|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
735240|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735241|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735242|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735243|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735244|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735245|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735246|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735247|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735248|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735249|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
735250|NCT00112294|E2|Reported Event|Taxane+Carboplatin|
735251|NCT00112294|E1|Reported Event|Cetuximab+Taxane+Carboplatin|
735252|NCT00112151|B7|Baseline|Total|Total of all reporting groups
735253|NCT00112151|B6|Baseline|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
735254|NCT00112151|B5|Baseline|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
735255|NCT00112151|B4|Baseline|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
735256|NCT00112151|B3|Baseline|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
735257|NCT00112151|B2|Baseline|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
735258|NCT00112151|B1|Baseline|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
735259|NCT00112151|P6|Participant Flow|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
735260|NCT00112151|P5|Participant Flow|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
735261|NCT00112151|P4|Participant Flow|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
735262|NCT00112151|P3|Participant Flow|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
735263|NCT00112151|P2|Participant Flow|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
735264|NCT00112151|P1|Participant Flow|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
735267|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
735269|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
735270|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
735271|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
735272|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
735273|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
735274|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
735275|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
735276|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
735277|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
735278|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
735279|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
735280|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
735281|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
735282|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
735283|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
735284|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
735285|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower or higher-range) plus progressive resistance training
735286|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower or higher-range); no exercise
735287|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
735288|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
735289|NCT00112151|E3|Reported Event|Higher-range T|T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training
735290|NCT00112151|E2|Reported Event|Lower-range T|T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training
735291|NCT00112151|E1|Reported Event|Placebo|Placebo gel with or without progressive resistance training
735292|NCT00112112|B3|Baseline|Total|Total of all reporting groups
735293|NCT00112112|B2|Baseline|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735294|NCT00112112|B1|Baseline|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735295|NCT00112112|P2|Participant Flow|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735296|NCT00112112|P1|Participant Flow|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735297|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735298|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735299|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735300|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735301|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735302|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735303|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735304|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735305|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735306|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
736080|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736081|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
735307|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735308|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735309|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735310|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735311|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735312|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735313|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735314|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735315|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735316|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735317|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735318|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735319|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735320|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735321|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735322|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735323|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735324|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735325|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735326|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735327|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735328|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735329|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735330|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
736082|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
735331|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735332|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735333|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735334|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735335|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735336|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735337|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735338|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735339|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735340|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735341|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735342|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735343|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735344|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735345|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735346|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735347|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735348|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735349|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735350|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735351|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735352|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735353|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735354|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
736083|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
735355|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735356|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735357|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735358|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735359|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735360|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735361|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735362|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735363|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735364|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735365|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735366|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735367|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735368|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735369|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735370|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735371|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735372|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735373|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735374|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735375|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735376|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735377|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735378|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
736084|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
735379|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735380|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735381|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735382|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735383|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735384|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735385|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735386|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735387|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735388|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735389|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735390|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735391|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735392|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735393|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735394|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735395|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735396|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735397|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735398|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735399|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735400|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735401|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735402|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
736085|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
735403|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735404|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735405|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735406|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735407|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735408|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735409|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735410|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735411|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735412|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735413|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735414|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735415|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735416|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735417|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735418|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735419|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735420|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735421|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735422|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735423|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735424|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735425|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735426|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
736086|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
735427|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735428|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735429|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735430|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735431|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735432|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735433|NCT00112112|E2|Reported Event|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
735434|NCT00112112|E1|Reported Event|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
735435|NCT00112047|B3|Baseline|Total|Total of all reporting groups
735436|NCT00112047|B2|Baseline|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735437|NCT00112047|B1|Baseline|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735438|NCT00112047|P2|Participant Flow|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735439|NCT00112047|P1|Participant Flow|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735440|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735441|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735442|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735443|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735444|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735445|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735446|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735447|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735448|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735449|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735450|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735451|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735452|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735453|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735454|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735455|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
736087|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
735456|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735457|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735458|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735459|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735460|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735461|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735462|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735463|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
735464|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735465|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735466|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735561|NCT00111839|O3|Outcome|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735467|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735468|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735469|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735470|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735471|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735472|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735473|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735474|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735562|NCT00111839|O2|Outcome|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735563|NCT00111839|O1|Outcome|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
735475|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735476|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735477|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735478|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735479|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735480|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735481|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735482|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735564|NCT00111839|O3|Outcome|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
736088|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
735483|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735484|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735485|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735486|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735487|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735488|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735489|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735490|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735565|NCT00111839|O2|Outcome|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735566|NCT00111839|O1|Outcome|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
735491|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735492|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735493|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735494|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735495|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735496|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735497|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735498|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735567|NCT00111839|O3|Outcome|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
736089|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
735499|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735500|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735501|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735502|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735503|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735504|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735505|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735506|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735568|NCT00111839|O2|Outcome|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735569|NCT00111839|O1|Outcome|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
735507|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735508|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735509|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735510|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735511|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735512|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735513|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735514|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735570|NCT00111839|O3|Outcome|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
736090|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
735515|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735516|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735517|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735518|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735519|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735520|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735521|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735522|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735571|NCT00111839|O2|Outcome|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735572|NCT00111839|O1|Outcome|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
735523|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735524|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735525|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735526|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735527|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735528|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735529|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735530|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735573|NCT00111839|E3|Reported Event|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
736091|NCT00110357|O2|Outcome|Group B (Ages 13-18 Years)|
736092|NCT00110357|O1|Outcome|Group A (Ages 1-12 Years)|
735531|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
735532|NCT00112047|E4|Reported Event|All Atripla (Week 144 to 240)|Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
735533|NCT00112047|E3|Reported Event|CBV+EFV (Baseline to 144 Weeks)|Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254.
735534|NCT00112047|E2|Reported Event|FTC+TDF+EFV/ATR (Baseline to 240 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160.
735535|NCT00112047|E1|Reported Event|FTC+TDF+EFV (Baseline to 144 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257.
735536|NCT00111917|B3|Baseline|Total|Total of all reporting groups
735537|NCT00111917|B2|Baseline|Control|CBD placed on placebo
735538|NCT00111917|B1|Baseline|Infliximab|patients who will be placed on infliximab and controls who will get placebo
735539|NCT00111917|P2|Participant Flow|Group 2 - Placebo|This group was given a placebo infusion
735540|NCT00111917|P1|Participant Flow|Group 1 - Infliximab|This group was given an infusion of inliximab
735541|NCT00111917|O2|Outcome|Group 2|Placebo received
735542|NCT00111917|O1|Outcome|Group 1|Infliximab
735543|NCT00111917|O2|Outcome|Placebo|Placebo received
735544|NCT00111917|O1|Outcome|Infliximab|Infliximab received
735545|NCT00111917|O2|Outcome|Placebo|Placebo infusion
735546|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
735547|NCT00111917|O2|Outcome|Placebo|Placebo infusion
735548|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
735549|NCT00111917|E2|Reported Event|Group 2 - Placebo|Placebo infusion received
735550|NCT00111917|E1|Reported Event|Group 1 - Infliximab|Infliximab infusion received
735551|NCT00111839|B4|Baseline|Total|Total of all reporting groups
735552|NCT00111839|B3|Baseline|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735553|NCT00111839|B2|Baseline|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735554|NCT00111839|B1|Baseline|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
735555|NCT00111839|P3|Participant Flow|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735556|NCT00111839|P2|Participant Flow|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735557|NCT00111839|P1|Participant Flow|Pemetrexed Alone|Participants received pemetrexed 50 milligrams per square meter (mg/m^2) intravenous (IV) infusion every 3 weeks until disease progression (PD) or the occurrence of unacceptable toxicity.
735558|NCT00111839|O3|Outcome|Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735559|NCT00111839|O2|Outcome|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735560|NCT00111839|O1|Outcome|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
736093|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
735574|NCT00111839|E2|Reported Event|Pemetrexed Plus Matuzumab 800 mg Per Week|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
735575|NCT00111839|E1|Reported Event|Pemetrexed Alone|Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
735576|NCT00111813|B1|Baseline|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
735577|NCT00111813|P6|Participant Flow|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735578|NCT00111813|P5|Participant Flow|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735579|NCT00111813|P4|Participant Flow|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735580|NCT00111813|P3|Participant Flow|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735581|NCT00111813|P2|Participant Flow|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735582|NCT00111813|P1|Participant Flow|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735583|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735584|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735585|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735586|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735587|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735588|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735589|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735590|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735591|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735592|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735593|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735594|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
736094|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
736163|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
735595|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735596|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735597|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735598|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735599|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735600|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735601|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735602|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735603|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735604|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735605|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735606|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735607|NCT00111813|O1|Outcome|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
735608|NCT00111813|E6|Reported Event|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735609|NCT00111813|E5|Reported Event|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735610|NCT00111813|E4|Reported Event|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735611|NCT00111813|E3|Reported Event|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
735612|NCT00111813|E2|Reported Event|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735613|NCT00111813|E1|Reported Event|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
735614|NCT00111800|B7|Baseline|Total|Total of all reporting groups
735615|NCT00111800|B6|Baseline|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735616|NCT00111800|B5|Baseline|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735617|NCT00111800|B4|Baseline|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735618|NCT00111800|B3|Baseline|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735619|NCT00111800|B2|Baseline|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735620|NCT00111800|B1|Baseline|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735621|NCT00111800|P6|Participant Flow|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735622|NCT00111800|P5|Participant Flow|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735623|NCT00111800|P4|Participant Flow|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735624|NCT00111800|P3|Participant Flow|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735625|NCT00111800|P2|Participant Flow|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735626|NCT00111800|P1|Participant Flow|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735627|NCT00111800|O5|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735628|NCT00111800|O4|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735629|NCT00111800|O3|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735630|NCT00111800|O2|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735631|NCT00111800|O1|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735632|NCT00111800|O5|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735633|NCT00111800|O4|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735634|NCT00111800|O3|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735635|NCT00111800|O2|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735636|NCT00111800|O1|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735637|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735638|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735639|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735640|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735641|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735642|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735643|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735644|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735645|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735646|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735647|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735648|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735649|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735650|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735651|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735652|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735653|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735654|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735655|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735656|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735657|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735658|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735659|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735660|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735661|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735662|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735663|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735869|NCT00110890|B1|Baseline|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
735664|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735665|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735666|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735667|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735668|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735669|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735670|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735671|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735672|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735673|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735674|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735675|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735676|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735677|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735678|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735983|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736095|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
735679|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735680|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735681|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735682|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735683|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735684|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735685|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735686|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735687|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735688|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735689|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735690|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735691|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735692|NCT00111800|O5|Outcome|DEN 15 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735693|NCT00111800|O4|Outcome|DEN 30 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
736062|NCT00110357|P1|Participant Flow|1- to 12-years-old|
736063|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
736158|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
735694|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735695|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735696|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735697|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735698|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735699|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735700|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735701|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735702|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735703|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735704|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735705|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735706|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735707|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735708|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
736064|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
736065|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
735709|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735710|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735711|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735712|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735713|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735714|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735715|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735716|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735717|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735718|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735719|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735720|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735721|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735722|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735723|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735724|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735725|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735726|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735727|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735728|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735729|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735730|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735731|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735732|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735733|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735734|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735735|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735736|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735737|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735738|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735739|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
736066|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736067|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
735740|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735741|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735742|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735743|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735744|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735745|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735746|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735747|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735748|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735749|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735750|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735751|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735752|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735753|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735754|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735755|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735756|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735757|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735758|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735759|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735760|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735761|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735762|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735763|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735764|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735765|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735766|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735767|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735768|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735769|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735770|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
736068|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
736069|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
735771|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735772|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735773|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735774|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735775|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735776|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735777|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735778|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735779|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735780|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735781|NCT00111800|O6|Outcome|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735782|NCT00111800|O5|Outcome|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735783|NCT00111800|O4|Outcome|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735784|NCT00111800|O3|Outcome|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735785|NCT00111800|O2|Outcome|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735818|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
736070|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
735786|NCT00111800|O1|Outcome|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735787|NCT00111800|E6|Reported Event|DEN 45 mg|Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
735788|NCT00111800|E5|Reported Event|DEN 30 mg|Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
735789|NCT00111800|E4|Reported Event|DEN 15 mg|Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
735790|NCT00111800|E3|Reported Event|DEN 7.5 mg|Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
735791|NCT00111800|E2|Reported Event|DEN 2.5 mg|Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
735792|NCT00111800|E1|Reported Event|Placebo|Participants received oral dose of matching placebo capsule to DEN once daily in the morning, 30 min prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mg once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
735793|NCT00111761|B3|Baseline|Total|Total of all reporting groups
735794|NCT00111761|B2|Baseline|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
735795|NCT00111761|B1|Baseline|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735796|NCT00111761|P2|Participant Flow|Panitumumab With IFL|Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735797|NCT00111761|P1|Participant Flow|Panitumumab With FOLFIRI|Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
735798|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735799|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735800|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735801|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735802|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735803|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735804|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
735805|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735806|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
735807|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
735808|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
735809|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
735810|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
735811|NCT00111761|E2|Reported Event|Panitumumab Plus FOLFIRI|
735812|NCT00111761|E1|Reported Event|Panitumumab Plus IFL|
735813|NCT00111657|B1|Baseline|Single Arm - Pegloticase|
735814|NCT00111657|P1|Participant Flow|Single Arm - Pegloticase|
735815|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
735816|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
735817|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
735819|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
735820|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
735821|NCT00111657|O1|Outcome|Single Arm|
735822|NCT00111657|E1|Reported Event|Single Arm - Pegloticase|
735823|NCT00111007|B3|Baseline|Total|Total of all reporting groups
735824|NCT00111007|B2|Baseline|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735825|NCT00111007|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735826|NCT00111007|P2|Participant Flow|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735827|NCT00111007|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735828|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735829|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735830|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735831|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735832|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735833|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735834|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735835|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735868|NCT00110890|B2|Baseline|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
736159|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
735836|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735837|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735838|NCT00111007|E2|Reported Event|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735839|NCT00111007|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735840|NCT00110994|B3|Baseline|Total|Total of all reporting groups
735841|NCT00110994|B2|Baseline|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735842|NCT00110994|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735843|NCT00110994|P2|Participant Flow|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735844|NCT00110994|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735845|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735846|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735847|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735848|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735849|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735850|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735851|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735852|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735853|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735854|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735855|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735856|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735857|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735858|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735859|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735860|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735861|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735862|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735863|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735864|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735865|NCT00110994|E2|Reported Event|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735866|NCT00110994|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
735867|NCT00110890|B3|Baseline|Total|Total of all reporting groups
736071|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
735870|NCT00110890|P2|Participant Flow|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
735871|NCT00110890|P1|Participant Flow|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
735872|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
735873|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
735874|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
735875|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
735876|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
735877|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
735878|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
735879|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
735880|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
735881|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
735882|NCT00110890|E2|Reported Event|Cinacalcet|
735883|NCT00110890|E1|Reported Event|Standard Care|
735884|NCT00110812|B4|Baseline|Total|Total of all reporting groups
735885|NCT00110812|B3|Baseline|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735886|NCT00110812|B2|Baseline|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735887|NCT00110812|B1|Baseline|No IL-2|Participants will receive no aldesleukin or HAART
735888|NCT00110812|P3|Participant Flow|IL-2 With Pericycle HAART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle). Patients did not receive aldesleukin during the extension phase.
735889|NCT00110812|P2|Participant Flow|IL-2 Without ART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Patients did not receive aldesleukin during the extension phase.
735890|NCT00110812|P1|Participant Flow|No IL-2|Participants will receive no aldesleukin or HAART during the main study or extension
735891|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
735892|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
735893|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
735894|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
735895|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
735896|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
735897|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
735898|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
736072|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
736160|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
735899|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735900|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735901|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735902|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735903|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735904|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735905|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735906|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735907|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735908|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735909|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735910|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735911|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735912|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735913|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735914|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735915|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735916|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735917|NCT00110812|O1|Outcome|IL-2 With Pericycle HAART|
735918|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735919|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735920|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735921|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735922|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735923|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735924|NCT00110812|O2|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735925|NCT00110812|O1|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
736161|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
735926|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
735927|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
735928|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
735929|NCT00110812|E3|Reported Event|No IL-2|
735930|NCT00110812|E2|Reported Event|IL-2 Without ART|
735931|NCT00110812|E1|Reported Event|IL-2 With Pericylce HAART|
735932|NCT00110617|B3|Baseline|Total|Total of all reporting groups
735933|NCT00110617|B2|Baseline|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
735934|NCT00110617|B1|Baseline|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
735935|NCT00110617|P2|Participant Flow|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
735936|NCT00110617|P1|Participant Flow|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
735937|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
735938|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
735939|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
735940|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
735941|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
735942|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
735943|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
735944|NCT00110617|E4|Reported Event|Period 2 Deferoxamine (DFO) Then ICL670|Period 2 (After 24 weeks) DFO group cross over to Deferasirox (ICL670) orally 20 mg/kg completing 52 weeks on therapy and then entering an extension period.
735945|NCT00110617|E3|Reported Event|Period 2 Deferasirox (ICL670)|Period 2 (after 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
735946|NCT00110617|E2|Reported Event|Period 1 Deferoxamine (DFO)|Period 1 (first 24 weeks) Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg.
735947|NCT00110617|E1|Reported Event|Period 1 Deferasirox (ICL670)|Period 1 (first 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
735948|NCT00110513|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
735949|NCT00110513|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
735950|NCT00110513|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level >80% and <120% of normal.
735951|NCT00110513|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
735952|NCT00110461|B4|Baseline|Total|Total of all reporting groups
735953|NCT00110461|B3|Baseline|Placebo|Participants were given a single pill administered once daily.
735954|NCT00110461|B2|Baseline|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735955|NCT00110461|B1|Baseline|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735956|NCT00110461|P3|Participant Flow|Placebo|Participants were given a single pill administered once daily.
735957|NCT00110461|P2|Participant Flow|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736073|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736162|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
735958|NCT00110461|P1|Participant Flow|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735959|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735960|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735961|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735962|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735963|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735964|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735965|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735966|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735967|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735968|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735969|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735970|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735971|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735972|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735973|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735974|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735975|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735976|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735977|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735978|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735979|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735980|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735981|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735982|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735984|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735985|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735986|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735987|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735988|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735989|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735990|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735991|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735992|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735993|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735994|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735995|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735996|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
735997|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
735998|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
735999|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736000|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736001|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736002|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736003|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736004|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736005|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736006|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736007|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736074|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736075|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
736076|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
736008|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736009|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736010|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736011|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736012|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736013|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736014|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736015|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736016|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736017|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736018|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736019|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736020|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736021|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736022|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736023|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736024|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736025|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736026|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736027|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736028|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736029|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736030|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736031|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736077|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
736078|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
736079|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
736032|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736033|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736034|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736035|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736036|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736037|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736038|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736039|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736040|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736041|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736042|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736043|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736044|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736045|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736046|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
736047|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736048|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736049|NCT00110461|E3|Reported Event|Placebo|Participants were given a single pill administered once daily.
736050|NCT00110461|E2|Reported Event|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
736051|NCT00110461|E1|Reported Event|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
736052|NCT00110396|B1|Baseline|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
736053|NCT00110396|P1|Participant Flow|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
736054|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
736055|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
736056|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
736057|NCT00110396|E1|Reported Event|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
736058|NCT00110357|B3|Baseline|Total|Total of all reporting groups
736059|NCT00110357|B2|Baseline|13- to 18-years-old|
736060|NCT00110357|B1|Baseline|1- to 12-years-old|
736061|NCT00110357|P2|Participant Flow|13- to 18-years-old|
736096|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736097|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736098|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
736099|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
736100|NCT00110357|O1|Outcome|Number of Participants|
736101|NCT00110357|O2|Outcome|Non-CNS Primary Tumor|
736102|NCT00110357|O1|Outcome|CNS Primary Tumor|
736103|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736104|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736105|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736106|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
736107|NCT00110357|O2|Outcome|Group A: 150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
736108|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
736109|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736110|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736111|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736112|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
736113|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
736114|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
736115|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736116|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736117|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736118|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
736119|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
736120|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
736121|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736122|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736123|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736124|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
736125|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
736126|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
736127|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736128|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736129|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
736130|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
736131|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
736132|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
736133|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
736134|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
736135|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
736136|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736137|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
736138|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
736139|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
736140|NCT00110357|E5|Reported Event|05 250 mg/m2 CET + 20 mg/m2 IRI|
736141|NCT00110357|E4|Reported Event|04 250 mg/m2 CET + 16 mg/m2 IRI|
736142|NCT00110357|E3|Reported Event|03 150 mg/m2 CET + 16 mg/m2 IRI|
736143|NCT00110357|E2|Reported Event|02 150 mg/m2 CET + 20 mg/m2 IRI|
736144|NCT00110357|E1|Reported Event|01 75 mg/m2 CET + 20 mg/m2 IRI|
736145|NCT00110305|B5|Baseline|Total|Total of all reporting groups
736146|NCT00110305|B4|Baseline|Efavirenz|Efavirenz 600 mg once daily
736147|NCT00110305|B3|Baseline|TMC 150 mg|TMC278 150 mg once daily
736148|NCT00110305|B2|Baseline|TMC278 75 mg|TMC278 75 mg once daily
736149|NCT00110305|B1|Baseline|TMC278 25 mg|TMC278 25 mg once daily
736150|NCT00110305|P2|Participant Flow|Efavirenz|Efavirenz 600 mg once daily
736151|NCT00110305|P1|Participant Flow|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736152|NCT00110305|O4|Outcome|AUC24h Quartile 4|TMC278 25 mg, 75 mg, and 150 mg once daily
736153|NCT00110305|O3|Outcome|AUC24h Quartile 3|TMC278 25 mg, 75 mg, and 150 mg once daily
736154|NCT00110305|O2|Outcome|AUC24h Quartile 2|TMC278 25 mg, 75 mg, and 150 mg once daily
736155|NCT00110305|O1|Outcome|AUC24h Quartile 1|TMC278 25 mg, 75 mg, and 150 mg once daily
736156|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
736157|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
736165|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736166|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
736167|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736168|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
736169|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736170|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
736171|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
736172|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
736173|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
736174|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736175|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
736176|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
736177|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
736178|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
736179|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736180|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
736181|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736182|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
736183|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736184|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
736185|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736186|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
736187|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
736188|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
736189|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
736190|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736191|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
736192|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
736193|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
736194|NCT00110305|O5|Outcome|Efavirenz|Efaviren 600 mg once daily
736195|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736196|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
736197|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
736198|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
736199|NCT00110305|E2|Reported Event|Efavirenz|Efavirenz 600 mg once daily
736200|NCT00110305|E1|Reported Event|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
736201|NCT00110214|B3|Baseline|Total|Total of all reporting groups
736202|NCT00110214|B2|Baseline|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
736203|NCT00110214|B1|Baseline|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
736204|NCT00110214|P2|Participant Flow|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
736205|NCT00110214|P1|Participant Flow|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
736206|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
736207|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
736208|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
736209|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
736210|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
736211|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
736212|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
736213|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
736214|NCT00110214|E2|Reported Event|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
736215|NCT00110214|E1|Reported Event|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
736216|NCT00110149|B1|Baseline|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
736217|NCT00110149|P1|Participant Flow|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
736218|NCT00110149|O1|Outcome|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
736219|NCT00110149|O1|Outcome|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|patient un treated NHL, who were then treated with the Rituximab and Y-90 Ibritumomab Tiuxetan.
736220|NCT00110149|E1|Reported Event|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan|Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
736221|NCT00110136|B1|Baseline|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736407|NCT00109577|O2|Outcome|Micronutrient Formula|nutritional supplement capsules
736222|NCT00110136|P1|Participant Flow|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736223|NCT00110136|O1|Outcome|St. John's Wort|"Patients given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736224|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736225|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736226|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736227|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736228|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736229|NCT00110136|E1|Reported Event|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
736230|NCT00110084|B1|Baseline|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
736231|NCT00110084|P1|Participant Flow|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
736232|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
736233|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
736234|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
736235|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
736236|NCT00110084|E1|Reported Event|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
736237|NCT00110019|B3|Baseline|Total|Total of all reporting groups
736238|NCT00110019|B2|Baseline|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
736239|NCT00110019|B1|Baseline|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
736240|NCT00110019|P2|Participant Flow|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
736241|NCT00110019|P1|Participant Flow|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
736242|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
736243|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
736244|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
736245|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
736246|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
736247|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
736248|NCT00110019|E2|Reported Event|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
736249|NCT00110019|E1|Reported Event|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
736250|NCT00109967|B3|Baseline|Total|Total of all reporting groups
736251|NCT00109967|B2|Baseline|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
736282|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736408|NCT00109577|O1|Outcome|Placebo Comparator|Placebo comparator capsules
750914|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
736252|NCT00109967|B1|Baseline|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
736253|NCT00109967|P2|Participant Flow|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736254|NCT00109967|P1|Participant Flow|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736255|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736256|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736257|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736258|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736259|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736260|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736261|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736262|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736263|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736264|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
736265|NCT00109967|E2|Reported Event|Group II: Rituximab Refractory|temsirolimus: 25 mg given IV
736266|NCT00109967|E1|Reported Event|Group I: Rituximab Sensitive|temsirolimus: 25 mg given IV
736267|NCT00109928|B1|Baseline|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
736268|NCT00109928|P1|Participant Flow|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
736269|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 6 cycles.)
736270|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
736271|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
736272|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
736273|NCT00109928|E1|Reported Event|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
736274|NCT00109876|B1|Baseline|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736275|NCT00109876|P1|Participant Flow|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736276|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736277|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736278|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736279|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736280|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736281|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736402|NCT00109577|B3|Baseline|Total|Total of all reporting groups
736283|NCT00109876|E1|Reported Event|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
736284|NCT00109850|B1|Baseline|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
736285|NCT00109850|P1|Participant Flow|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
736286|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
736287|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
736288|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
736289|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
736290|NCT00109850|E1|Reported Event|Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
736291|NCT00109837|B1|Baseline|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
736292|NCT00109837|P1|Participant Flow|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
736293|NCT00109837|O1|Outcome|Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
736294|NCT00109837|O1|Outcome|Treatment|Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
736295|NCT00109837|E4|Reported Event|Maintenance|Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate
736296|NCT00109837|E3|Reported Event|Consolidation|Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate
736297|NCT00109837|E2|Reported Event|Second Induction|A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone
736298|NCT00109837|E1|Reported Event|First Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
736299|NCT00109772|B3|Baseline|Total|Total of all reporting groups
736300|NCT00109772|B2|Baseline|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736301|NCT00109772|B1|Baseline|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736302|NCT00109772|P2|Participant Flow|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736303|NCT00109772|P1|Participant Flow|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736304|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736305|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736403|NCT00109577|B2|Baseline|Micronutrient Formula|nutritional supplement
736404|NCT00109577|B1|Baseline|Placebo Comparator|Placebo comparator
736306|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736307|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736308|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736309|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736310|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736311|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736312|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736313|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736314|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736315|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736316|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736317|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736318|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736319|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736320|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736321|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736322|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736323|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736324|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736325|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736326|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736327|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736328|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736329|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736330|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736331|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736332|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736333|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736334|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736335|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736336|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736337|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736338|NCT00109772|E2|Reported Event|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736339|NCT00109772|E1|Reported Event|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
736340|NCT00109733|B3|Baseline|Total|Total of all reporting groups
736341|NCT00109733|B2|Baseline|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736342|NCT00109733|B1|Baseline|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736343|NCT00109733|P2|Participant Flow|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736344|NCT00109733|P1|Participant Flow|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736345|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736346|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736347|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736348|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736349|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736350|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736351|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736352|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736353|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736354|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736355|NCT00109733|E2|Reported Event|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
736356|NCT00109733|E1|Reported Event|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
736357|NCT00109590|B4|Baseline|Total|Total of all reporting groups
736358|NCT00109590|B3|Baseline|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736359|NCT00109590|B2|Baseline|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736360|NCT00109590|B1|Baseline|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736361|NCT00109590|P3|Participant Flow|Arm C: LPV/r x 30d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736362|NCT00109590|P2|Participant Flow|Arm B : no LPV/r|Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally once daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736363|NCT00109590|P1|Participant Flow|Arm A : LPV/r x 7d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, > Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736364|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
736365|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
736366|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
736367|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
736368|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
736369|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
736370|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736371|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736372|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally QD (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736373|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736374|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736375|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736376|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736377|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736405|NCT00109577|P2|Participant Flow|Micronutrient Formula|nutritional supplement capsules containing 36-ingredients primarily vitamins and minerals; the supplement is referred to as MCN36, because it contains 36 nutrients.
736406|NCT00109577|P1|Participant Flow|Placebo Comparator|Placebo comparator capsules
736378|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736379|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736380|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736381|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736382|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736383|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736384|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736385|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736386|NCT00109590|O2|Outcome|Arm B: no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736387|NCT00109590|O1|Outcome|Arm A: LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7days postpartum.
736388|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
736389|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
736390|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736391|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736392|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736393|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
736394|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
736395|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
736396|NCT00109590|E6|Reported Event|Infant: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
736397|NCT00109590|E5|Reported Event|Infant: no LPV/r|ZDV & ddI x 30d
736398|NCT00109590|E4|Reported Event|Infant: LPV/r x 7d|NVP 200 mg orally, single dose at onset
736399|NCT00109590|E3|Reported Event|Mother: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
736400|NCT00109590|E2|Reported Event|Mother: no LPV/r|ZDV & ddI x 30d
736401|NCT00109590|E1|Reported Event|Mother: LPV/r x 7d|NVP 200 mg orally, single dose at onset
736409|NCT00109577|E2|Reported Event|Micronutrient Formula|nutritional supplement
736410|NCT00109577|E1|Reported Event|Placebo Comparator|Placebo comparator
736411|NCT00109473|B3|Baseline|Total|Total of all reporting groups
736412|NCT00109473|B2|Baseline|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736413|NCT00109473|B1|Baseline|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736414|NCT00109473|P2|Participant Flow|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736415|NCT00109473|P1|Participant Flow|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736416|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736417|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736418|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736419|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736420|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736421|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736422|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736423|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736424|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736425|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736426|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736427|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736428|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
736429|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736430|NCT00109473|E3|Reported Event|Extension Phase|Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
736431|NCT00109473|E2|Reported Event|Corticosteroid (CTX)|Subjects took corticosteroid as recommended by their physician
736432|NCT00109473|E1|Reported Event|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
736433|NCT00109343|B4|Baseline|Total|Total of all reporting groups
736434|NCT00109343|B3|Baseline|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736435|NCT00109343|B2|Baseline|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736436|NCT00109343|B1|Baseline|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736437|NCT00109343|P3|Participant Flow|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736438|NCT00109343|P2|Participant Flow|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736439|NCT00109343|P1|Participant Flow|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736440|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736441|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736442|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736443|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736444|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736870|NCT00107900|E4|Reported Event|60mg QD|60mg edoxaban administered once daily (QD)
736871|NCT00107900|E3|Reported Event|30mg BID|30mg edoxaban administered twice daily (BID)
736445|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736446|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736447|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736448|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736449|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736450|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736451|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736452|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736453|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736454|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736455|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736456|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736457|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736458|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736459|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736460|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736461|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736462|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736463|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736464|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736465|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736466|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
736467|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736468|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736469|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736470|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736471|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736472|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736473|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736474|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736475|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
736476|NCT00109343|E3|Reported Event|ProQuad™ (After Dose 2)|ProQuad™ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
736477|NCT00109343|E2|Reported Event|ProQuad™ Alone (After Dose 1)|ProQuad™ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2).
736478|NCT00109343|E1|Reported Event|ProQuad™ + Prevnar™ (After Dose 1)|ProQuad™ + Prevnar™ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 1)
736479|NCT00109031|B5|Baseline|Total|Total of all reporting groups
736480|NCT00109031|B4|Baseline|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736481|NCT00109031|B3|Baseline|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736482|NCT00109031|B2|Baseline|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736483|NCT00109031|B1|Baseline|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736484|NCT00109031|P4|Participant Flow|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
736485|NCT00109031|P3|Participant Flow|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
736486|NCT00109031|P2|Participant Flow|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and matched placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
736487|NCT00109031|P1|Participant Flow|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
736488|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736489|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736490|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
750915|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
736491|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736492|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736493|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736494|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736495|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736496|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736497|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736498|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736499|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736500|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736501|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736502|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736503|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736504|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736505|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736506|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736507|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736508|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736509|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736510|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736511|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736512|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736513|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736514|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736515|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736516|NCT00109031|E4|Reported Event|Palifermin 180 μg/kg on Day −3 (D)|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736517|NCT00109031|E3|Reported Event|Palifermin 180 μg/kg on Day −2 (C)|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736518|NCT00109031|E2|Reported Event|Palifermin 180 μg/kg on Day −1 (B)|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
736519|NCT00109031|E1|Reported Event|Palifermin 60 µg/kg for 3 Days (A)|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
736520|NCT00109005|B3|Baseline|Total|Total of all reporting groups
736521|NCT00109005|B2|Baseline|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736522|NCT00109005|B1|Baseline|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
736523|NCT00109005|P2|Participant Flow|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736524|NCT00109005|P1|Participant Flow|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
736525|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736526|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736527|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736528|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736529|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736530|NCT00109005|O2|Outcome|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736531|NCT00109005|O1|Outcome|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
736532|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736533|NCT00109005|E2|Reported Event|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
736534|NCT00109005|E1|Reported Event|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
736535|NCT00108953|B3|Baseline|Total|Total of all reporting groups
736536|NCT00108953|B2|Baseline|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736537|NCT00108953|B1|Baseline|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736538|NCT00108953|P2|Participant Flow|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736539|NCT00108953|P1|Participant Flow|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736540|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736541|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736542|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736543|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736544|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736545|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736546|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736547|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736548|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736549|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736550|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736551|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736552|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736553|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736554|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736872|NCT00107900|E2|Reported Event|30mg QD|30mg edoxaban administered once daily (QD)
750916|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
736555|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736556|NCT00108953|E2|Reported Event|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736557|NCT00108953|E1|Reported Event|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
736558|NCT00108862|B3|Baseline|Total|Total of all reporting groups
736559|NCT00108862|B2|Baseline|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736560|NCT00108862|B1|Baseline|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736561|NCT00108862|P2|Participant Flow|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736562|NCT00108862|P1|Participant Flow|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736563|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736564|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736565|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736614|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736566|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736567|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736568|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736569|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736570|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736571|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736572|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736573|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736681|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
750917|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
736574|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736575|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736576|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736577|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736578|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736579|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736580|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736581|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736682|NCT00108355|E2|Reported Event|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
736873|NCT00107900|E1|Reported Event|15mg BID|15mg edoxaban administered twice daily (BID)
736582|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736583|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736584|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736585|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736586|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736587|NCT00108862|E2|Reported Event|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
736588|NCT00108862|E1|Reported Event|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
736589|NCT00108732|B1|Baseline|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
736683|NCT00108355|E1|Reported Event|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
736684|NCT00108342|B3|Baseline|Total|Total of all reporting groups
736590|NCT00108732|P1|Participant Flow|Vaccinia/Fowlpox/GM-CSF|"There are two steps in this study. Patients receive vaccine treatment in Step 1. Patients with biochemical or clinical progression during Step 1 were eligible to continue on to androgen blockade in Step 2. This report includes information collected in Step 1 only.~Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start Step II androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
736591|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
736592|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
736593|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
736594|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
736595|NCT00108732|E1|Reported Event|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
736596|NCT00108628|B3|Baseline|Total|Total of all reporting groups
736597|NCT00108628|B2|Baseline|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736598|NCT00108628|B1|Baseline|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736599|NCT00108628|P2|Participant Flow|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736600|NCT00108628|P1|Participant Flow|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736662|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736874|NCT00107783|B3|Baseline|Total|Total of all reporting groups
736601|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736602|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736603|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736604|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736605|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736606|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736607|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736608|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736609|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736610|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736611|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736612|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736613|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736685|NCT00108342|B2|Baseline|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
736615|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736616|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736617|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736618|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736619|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736620|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736621|NCT00108628|E2|Reported Event|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
736622|NCT00108628|E1|Reported Event|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
736623|NCT00108550|B3|Baseline|Total|Total of all reporting groups
736624|NCT00108550|B2|Baseline|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
736625|NCT00108550|B1|Baseline|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
736626|NCT00108550|P2|Participant Flow|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
736627|NCT00108550|P1|Participant Flow|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
736628|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
736629|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
736630|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
736631|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
736632|NCT00108550|E2|Reported Event|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
736633|NCT00108550|E1|Reported Event|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
736634|NCT00108524|B3|Baseline|Total|Total of all reporting groups
736635|NCT00108524|B2|Baseline|Arm 2|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
736636|NCT00108524|B1|Baseline|Arm 1|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
736680|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
736637|NCT00108524|P2|Participant Flow|Low-Fat Diet Plus Orlistat|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
736638|NCT00108524|P1|Participant Flow|Low Carbohydrate Ketogenic Diet|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
736639|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
736640|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
736641|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
736642|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
736643|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
736644|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
736645|NCT00108524|E2|Reported Event|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
736646|NCT00108524|E1|Reported Event|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
736647|NCT00108485|B3|Baseline|Total|Total of all reporting groups
736648|NCT00108485|B2|Baseline|Placebo|Placebo tablets
736649|NCT00108485|B1|Baseline|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
736650|NCT00108485|P2|Participant Flow|Placebo|Placebo tablets
736651|NCT00108485|P1|Participant Flow|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
736652|NCT00108485|O2|Outcome|Placebo|Placebo tablets
736653|NCT00108485|O1|Outcome|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
736654|NCT00108485|E2|Reported Event|Placebo|Placebo tablets
736655|NCT00108485|E1|Reported Event|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
736656|NCT00108433|B3|Baseline|Total|Total of all reporting groups
736657|NCT00108433|B2|Baseline|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736658|NCT00108433|B1|Baseline|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736659|NCT00108433|P2|Participant Flow|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736660|NCT00108433|P1|Participant Flow|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736661|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736875|NCT00107783|B2|Baseline|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736663|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736664|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736665|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736666|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736667|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736668|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736669|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736670|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736671|NCT00108433|E2|Reported Event|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
736672|NCT00108433|E1|Reported Event|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
736673|NCT00108355|B3|Baseline|Total|Total of all reporting groups
736674|NCT00108355|B2|Baseline|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
736675|NCT00108355|B1|Baseline|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
736676|NCT00108355|P2|Participant Flow|Vasoconstrictors (Study Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
736677|NCT00108355|P1|Participant Flow|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
736678|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
736679|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
736876|NCT00107783|B1|Baseline|Control|No treatment
750918|NCT00056472|E2|Reported Event|Monotherapy|placebo plus olanzapine
736686|NCT00108342|B1|Baseline|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
736687|NCT00108342|P2|Participant Flow|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
736688|NCT00108342|P1|Participant Flow|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
736689|NCT00108342|O2|Outcome|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
736690|NCT00108342|O1|Outcome|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
736691|NCT00108342|E2|Reported Event|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
736692|NCT00108342|E1|Reported Event|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
736693|NCT00108303|B4|Baseline|Total|Total of all reporting groups
736694|NCT00108303|B3|Baseline|Controls|Persons who are not related to persons in Arm 2 and do not have schizophrenia themselves.
736695|NCT00108303|B2|Baseline|Schizophrenia Relatives|Persons who are first degree relatives of persons in Arm 1
736696|NCT00108303|B1|Baseline|Schizophrenia Probands|Persons who meet DSM-IV criteria for schizophrenia or schizoaffective disorder
736697|NCT00108303|P3|Participant Flow|Controls|Subjects who are unrelated to persons with schizophrenia and do not fulfill criteria for schizophrenia themselves.
736698|NCT00108303|P2|Participant Flow|Schizophrenia Relatives|Subjects who are first degree relatives of subjects in Arm 1.
736699|NCT00108303|P1|Participant Flow|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder.
736700|NCT00108303|O3|Outcome|Controls|Persons who are not relatives of persons with schizophrenia and do not have schizophrenia themselves.
736701|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are relatives of probands in Group 1.
736702|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia.
736703|NCT00108303|O3|Outcome|Controls|Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
736704|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are siblings or children of someone with schizophrenia
736705|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who have schizophrenia as determined by diagnosis
736706|NCT00108303|O1|Outcome|Group 1|Subjects who receive genetic study.
736707|NCT00108303|E3|Reported Event|Controls|Controls who do not have personal or family history of schizophrenia
736708|NCT00108303|E2|Reported Event|Schizophrenia Relatives|Schizophrenia relatives who siblings or children of persons with schizophrenia
736709|NCT00108303|E1|Reported Event|Schizophrenia Probands|Schizophrenia probands as diagnosed as having schizophrenia
736710|NCT00108277|B4|Baseline|Total|Total of all reporting groups
736711|NCT00108277|B3|Baseline|Waitlist|"Waitlist~Treatment as usual"
736712|NCT00108277|B2|Baseline|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
736713|NCT00108277|B1|Baseline|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
736714|NCT00108277|P3|Participant Flow|Waitlist|Waitlist Treatment as Usual
736715|NCT00108277|P2|Participant Flow|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
736716|NCT00108277|P1|Participant Flow|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
736717|NCT00108277|O3|Outcome|Waitlist|Waitlist Treatment as usual
736718|NCT00108277|O2|Outcome|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2"
736719|NCT00108277|O1|Outcome|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 breaths per minute, patients are instructed to raise CO2"
736720|NCT00108277|E3|Reported Event|Waitlist|Treatment as usual
736721|NCT00108277|E2|Reported Event|Lower CO2|Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2
736722|NCT00108277|E1|Reported Event|Raise CO2|Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2
736723|NCT00108160|B3|Baseline|Total|Total of all reporting groups
736724|NCT00108160|B2|Baseline|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Placebo Group).
736725|NCT00108160|B1|Baseline|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Treatment Group).
736726|NCT00108160|P2|Participant Flow|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736727|NCT00108160|P1|Participant Flow|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736728|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment [Placebo]|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736729|NCT00108160|O1|Outcome|Mupirocin Ointment [Treatment]|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736730|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736879|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736731|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736732|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736733|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736734|NCT00108160|E2|Reported Event|Polyethylene Glycol Ointment|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736735|NCT00108160|E1|Reported Event|Mupirocin Ointment|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
736736|NCT00108082|B4|Baseline|Total|Total of all reporting groups
736737|NCT00108082|B3|Baseline|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736738|NCT00108082|B2|Baseline|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736739|NCT00108082|B1|Baseline|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736740|NCT00108082|P3|Participant Flow|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736741|NCT00108082|P2|Participant Flow|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736742|NCT00108082|P1|Participant Flow|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736743|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736744|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736745|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736746|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736747|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736748|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736749|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736750|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736751|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736752|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736753|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736754|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736755|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736877|NCT00107783|P2|Participant Flow|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736756|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736757|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736758|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736759|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736760|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736761|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736762|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736763|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736764|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736765|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736766|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736767|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736768|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736769|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736770|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736771|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736772|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736773|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736774|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736775|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736776|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736777|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736815|NCT00107978|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
736878|NCT00107783|P1|Participant Flow|Control|No treatment
736778|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736779|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736780|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736781|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736782|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736783|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736784|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736785|NCT00108082|E3|Reported Event|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736786|NCT00108082|E2|Reported Event|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
736787|NCT00108082|E1|Reported Event|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
736788|NCT00108069|B3|Baseline|Total|Total of all reporting groups
736789|NCT00108069|B2|Baseline|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736790|NCT00108069|B1|Baseline|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736791|NCT00108069|P2|Participant Flow|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736792|NCT00108069|P1|Participant Flow|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736793|NCT00108069|O6|Outcome|Total|Total number of participants.
736794|NCT00108069|O5|Outcome|Grade 5|Death related to adverse event
736795|NCT00108069|O4|Outcome|Grade 4|Life-threatening or disabling adverse event
736796|NCT00108069|O3|Outcome|Grade 3|Severe adverse event
736797|NCT00108069|O2|Outcome|Grade 2|Moderate adverse event
736798|NCT00108069|O1|Outcome|Grade 1|Mild adverse event
736799|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736800|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736801|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736802|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736803|NCT00108069|E2|Reported Event|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736804|NCT00108069|E1|Reported Event|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
736805|NCT00107991|B1|Baseline|Etanercept|50 mg/week subcutaneously
736806|NCT00107991|P1|Participant Flow|Etanercept|50 mg/week subcutaneously
736807|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
736808|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
736809|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
736810|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
736811|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
736812|NCT00107991|E1|Reported Event|Etanercept|50 mg/week subcutaneously
736813|NCT00107978|B3|Baseline|Total|Total of all reporting groups
736814|NCT00107978|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
736880|NCT00107783|O1|Outcome|Control|No treatment
736816|NCT00107978|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
736817|NCT00107978|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
736818|NCT00107978|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
736819|NCT00107978|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
736820|NCT00107978|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
736821|NCT00107978|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
736822|NCT00107952|B3|Baseline|Total|Total of all reporting groups
736823|NCT00107952|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
736824|NCT00107952|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
736825|NCT00107952|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
736826|NCT00107952|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
736827|NCT00107952|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
736828|NCT00107952|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
736829|NCT00107952|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
736830|NCT00107952|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
736831|NCT00107900|B7|Baseline|Total|Total of all reporting groups
736832|NCT00107900|B6|Baseline|120mg QD|120mg edoxaban administered once daily (QD)
736833|NCT00107900|B5|Baseline|60mg BID|60mg edoxaban administered twice daily (BID)
736834|NCT00107900|B4|Baseline|60mg QD|60mg edoxaban administered once daily (QD)
736835|NCT00107900|B3|Baseline|30mg BID|30mg edoxaban administered twice daily (BID)
736836|NCT00107900|B2|Baseline|30mg QD|30mg edoxaban administered once daily (QD)
736837|NCT00107900|B1|Baseline|15mg BID|15mg edoxaban administered twice daily (BID)
736838|NCT00107900|P6|Participant Flow|120mg QD|120mg edoxaban administered once daily (QD)
736839|NCT00107900|P5|Participant Flow|60mg BID|60mg edoxaban administered twice daily (BID)
736840|NCT00107900|P4|Participant Flow|60mg QD|60mg edoxaban administered once daily (QD)
736841|NCT00107900|P3|Participant Flow|30mg BID|30mg edoxaban administered twice daily (BID)
736842|NCT00107900|P2|Participant Flow|30mg QD|30mg edoxaban administered once daily (QD)
736843|NCT00107900|P1|Participant Flow|15mg BID|15mg edoxaban administered twice daily (BID)
736844|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
736845|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
736846|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
736847|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
736848|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
736849|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
736850|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
736851|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
736852|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
736853|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
736854|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
736855|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
736856|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
736857|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
736858|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
736859|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
736860|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
736861|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
736862|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
736863|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
736864|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
736865|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
736866|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
736867|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
736868|NCT00107900|E6|Reported Event|120mg QD|120mg edoxaban administered once daily (QD)
736869|NCT00107900|E5|Reported Event|60mg BID|60mg edoxaban administered twice daily (BID)
736881|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736882|NCT00107783|O1|Outcome|Control|No treatment
736883|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736884|NCT00107783|O1|Outcome|Control|No treatment
736885|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736886|NCT00107783|O1|Outcome|Control|No treatment
736887|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736888|NCT00107783|O1|Outcome|Control|No treatment
736889|NCT00107783|E2|Reported Event|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
736890|NCT00107783|E1|Reported Event|Control|No treatment
736891|NCT00107653|B3|Baseline|Total|Total of all reporting groups
736892|NCT00107653|B2|Baseline|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736893|NCT00107653|B1|Baseline|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736894|NCT00107653|P2|Participant Flow|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736895|NCT00107653|P1|Participant Flow|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736896|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736897|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736898|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736899|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736900|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736901|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736902|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736903|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736904|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736905|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
737056|NCT00107042|O2|Outcome|Ever Used Drugs Not Prescribed: YES|Subjects who have used drugs that were not prescribed.
736906|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736907|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736908|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736909|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736910|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736911|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736912|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736913|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736914|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736915|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736916|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736917|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736918|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736919|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736920|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736921|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736968|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736922|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736923|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736924|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736925|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736926|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736927|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736928|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736929|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736930|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736931|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736932|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736933|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736934|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736935|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736936|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736937|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736969|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736938|NCT00107653|E2|Reported Event|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
736939|NCT00107653|E1|Reported Event|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
736940|NCT00107614|B1|Baseline|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
736941|NCT00107614|P1|Participant Flow|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
736942|NCT00107614|O1|Outcome|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
736943|NCT00107614|E1|Reported Event|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
736944|NCT00107575|B3|Baseline|Total|Total of all reporting groups
736945|NCT00107575|B2|Baseline|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736946|NCT00107575|B1|Baseline|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736947|NCT00107575|P2|Participant Flow|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736948|NCT00107575|P1|Participant Flow|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736949|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736950|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736951|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736952|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736953|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736954|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736955|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736956|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736957|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736958|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736959|NCT00107575|E2|Reported Event|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
736960|NCT00107575|E1|Reported Event|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
736961|NCT00107536|B1|Baseline|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736962|NCT00107536|P1|Participant Flow|Lapatinib|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736963|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736964|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736965|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736966|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736967|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
751899|NCT00046891|O2|Outcome|Plan Ahead|Self-report cognition
736970|NCT00107536|E1|Reported Event|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
736971|NCT00107380|B1|Baseline|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
736972|NCT00107380|P1|Participant Flow|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
736973|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
736974|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
736975|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
736976|NCT00107380|E1|Reported Event|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
736977|NCT00107315|B1|Baseline|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
736978|NCT00107315|P1|Participant Flow|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
736979|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
736980|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
736981|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
736982|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
736983|NCT00107315|E1|Reported Event|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
736984|NCT00107276|B1|Baseline|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
736985|NCT00107276|P1|Participant Flow|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
736986|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|
736987|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
736988|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
736989|NCT00107276|E1|Reported Event|Cyclophosphamide and Capecitabine|
736990|NCT00107198|B1|Baseline|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
737004|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737005|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737252|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
736991|NCT00107198|P1|Participant Flow|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
736992|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
736993|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
736994|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
736995|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
736996|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
736997|NCT00107198|E1|Reported Event|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
736998|NCT00107172|B3|Baseline|Total|Total of all reporting groups
736999|NCT00107172|B2|Baseline|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737000|NCT00107172|B1|Baseline|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737001|NCT00107172|P2|Participant Flow|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737002|NCT00107172|P1|Participant Flow|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737003|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737006|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737007|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737008|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737009|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737010|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737011|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737012|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737013|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737014|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737015|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737016|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737017|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737018|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737019|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737020|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737021|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737022|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737023|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737024|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737025|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737026|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737027|NCT00107172|E2|Reported Event|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
737028|NCT00107172|E1|Reported Event|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
737029|NCT00107120|B3|Baseline|Total|Total of all reporting groups
737030|NCT00107120|B2|Baseline|Placebo|Once daily oral administration of placebo tablets
737031|NCT00107120|B1|Baseline|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
737032|NCT00107120|P2|Participant Flow|Placebo|Once daily oral administration of placebo tablets
737033|NCT00107120|P1|Participant Flow|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
737034|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
737035|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
737036|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
737037|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
737038|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
737039|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
737040|NCT00107120|E2|Reported Event|Placebo|Once daily oral administration of placebo tablets
737041|NCT00107120|E1|Reported Event|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
737042|NCT00107042|B3|Baseline|Total|Total of all reporting groups
737043|NCT00107042|B2|Baseline|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737044|NCT00107042|B1|Baseline|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737045|NCT00107042|P2|Participant Flow|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737046|NCT00107042|P1|Participant Flow|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737047|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737048|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737049|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737050|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737051|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737052|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737053|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737054|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737055|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737057|NCT00107042|O1|Outcome|Ever Used Drugs Not Prescribed: NO|Subjects who have never used drugs that were not prescribed.
737058|NCT00107042|O2|Outcome|Ever Smoked Marijuana: YES|Subjects who have smoked marijuana
737059|NCT00107042|O1|Outcome|Ever Smoked Marijuana: NO|Subjects who have never smoked marijuana
737060|NCT00107042|O2|Outcome|Ever Drank Alcohol: YES|Subjects who have drank alcohol
737061|NCT00107042|O1|Outcome|Ever Drank Alcohol: NO|Subjects who have never drank alcohol
737062|NCT00107042|O3|Outcome|>= 6 Female Sex Partners|Male and female subjects who have had 6 or more lifetime female sex partners
737063|NCT00107042|O2|Outcome|1-5 Female Sex Partners|Male and female Subjects who have had 1 - 5 lifetime female sex partners
737064|NCT00107042|O1|Outcome|0 Female Sex Partners|Male and female subjects who have never had a female sex partner
737065|NCT00107042|O3|Outcome|>= 6 Male Sex Partners|Male and female subjects who have had 6 or more lifetime male sex partners
737066|NCT00107042|O2|Outcome|1-5 Male Sex Partners|Male and female subjects who have had 1 - 5 lifetime male sex partners
737067|NCT00107042|O1|Outcome|0 Male Sex Partners|Male and female subjects who have never had a male sex partner
737068|NCT00107042|O3|Outcome|>= 6 Sex Partners|Subjects who have had 6 or more lifetime sex partners
737069|NCT00107042|O2|Outcome|1 - 5 Sex Partners|Subjects who have had 1 - 5 lifetime sex partners
737070|NCT00107042|O1|Outcome|0 Sex Partners|Subjects who have never had a sex partner
737071|NCT00107042|O3|Outcome|15-17 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 15 and 17, inclusive
737072|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 12 and 14, inclusive
737073|NCT00107042|O1|Outcome|Never|Subjects who reported they never had anal or vaginal sex because they wanted to.
737074|NCT00107042|O2|Outcome|Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided|Subjects who were either gay (homosexual), bisexual, not sure or undecided.
737075|NCT00107042|O1|Outcome|Straight (Heterosexual)|Subjects who were straight (heterosexual)
737076|NCT00107042|O2|Outcome|Ever Smoked Cigarettes: YES|Subjects who have smoked cigarettes
737077|NCT00107042|O1|Outcome|Ever Smoked Cigarettes: NO|Subjects who have never smoked cigarettes
737078|NCT00107042|O2|Outcome|Overweight and Obese (>=25.0)|Subjects whose BMIs were >= 25.0
737079|NCT00107042|O1|Outcome|Normal and Underweight (< 25.0)|Subjects whose BMIs were normal to < 25.0
737080|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Males)|Males who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
737081|NCT00107042|O1|Outcome|Tanner Stage 5 (Males)|Males who were self-assessed and categorized to Tanner Stage 5.
737082|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Females)|Females who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
737083|NCT00107042|O1|Outcome|Tanner Stage 5 (Females)|Females who were self-assessed and categorized to Tanner Stage 5.
737084|NCT00107042|O3|Outcome|Black/African American|Subjects who reported their race to be black or African American
737085|NCT00107042|O2|Outcome|Other/Mixed Race|Subjects who reported their race to be other than white, black, or of mixed race.
737086|NCT00107042|O1|Outcome|White|Subjects who reported their race to be white.
737087|NCT00107042|O2|Outcome|Hispanic|Subjects who reported they were of Hispanic ethnicity.
737088|NCT00107042|O1|Outcome|Not Hispanic|Subjects who reported they were not of Hispanic ethnicity.
737089|NCT00107042|O2|Outcome|Male|Male Subjects
737090|NCT00107042|O1|Outcome|Female|Female Subjects
737091|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects between the ages of 12 and 14 years, inclusive
737092|NCT00107042|O1|Outcome|15-17 Years of Age|Subjects between the ages of 15 and 17 years, inclusive
737093|NCT00107042|O2|Outcome|Baltimore|Clinical site where subjects were enrolled.
737094|NCT00107042|O1|Outcome|Other Sites|All other clinical sites (besides the Baltimore site) where subjects were enrolled.
737095|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737096|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Wk 24
737097|NCT00107042|O1|Outcome|All Participants|All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.
737098|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737099|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737100|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737101|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737102|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737103|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737104|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737105|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737106|NCT00107042|E2|Reported Event|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
737107|NCT00107042|E1|Reported Event|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
737108|NCT00106964|B4|Baseline|Total|Total of all reporting groups
737109|NCT00106964|B3|Baseline|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737110|NCT00106964|B2|Baseline|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737111|NCT00106964|B1|Baseline|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737112|NCT00106964|P3|Participant Flow|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737113|NCT00106964|P2|Participant Flow|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
751900|NCT00046891|O1|Outcome|Solve Problems|Self-report cognition
737114|NCT00106964|P1|Participant Flow|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737115|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737116|NCT00106964|O2|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737117|NCT00106964|O1|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737118|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737119|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737120|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737121|NCT00106964|O3|Outcome|3: Twindrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737122|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737123|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737124|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
737125|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
737126|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
737127|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
737128|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
737129|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
737130|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737131|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737132|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737133|NCT00106964|E3|Reported Event|3. Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737134|NCT00106964|E2|Reported Event|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737135|NCT00106964|E1|Reported Event|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
737136|NCT00106938|B3|Baseline|Total|Total of all reporting groups
737137|NCT00106938|B2|Baseline|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737138|NCT00106938|B1|Baseline|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737139|NCT00106938|P2|Participant Flow|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737140|NCT00106938|P1|Participant Flow|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737141|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737142|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737143|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737144|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737145|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737146|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737147|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737148|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737149|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737253|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737150|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737151|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737152|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737153|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737154|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737155|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737156|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737157|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737158|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737159|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737160|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737161|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737162|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737163|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737164|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737165|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737166|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737167|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737168|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737169|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737170|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737171|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737172|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737173|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737174|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737175|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737176|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737177|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737251|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737178|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737179|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737180|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737181|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737182|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737183|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737184|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737185|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737186|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737187|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737188|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737189|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737190|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737191|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737192|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737193|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737194|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737195|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737196|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737197|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737198|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737199|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737200|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737201|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737202|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737203|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737204|NCT00106938|E2|Reported Event|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737205|NCT00106938|E1|Reported Event|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
737206|NCT00106704|B3|Baseline|Total|Total of all reporting groups
751901|NCT00046891|O3|Outcome|Balance Checkbook|Self-report cognition
737207|NCT00106704|B2|Baseline|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737208|NCT00106704|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737209|NCT00106704|P2|Participant Flow|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737210|NCT00106704|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737211|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737212|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737213|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737214|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737215|NCT00106704|E2|Reported Event|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737216|NCT00106704|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
737217|NCT00106639|B4|Baseline|Total|Total of all reporting groups
737218|NCT00106639|B3|Baseline|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737219|NCT00106639|B2|Baseline|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737220|NCT00106639|B1|Baseline|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737221|NCT00106639|P3|Participant Flow|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737222|NCT00106639|P2|Participant Flow|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737223|NCT00106639|P1|Participant Flow|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737224|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737225|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737226|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737227|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737228|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737229|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737230|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737231|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737232|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737233|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737234|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737235|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737236|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737237|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737238|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737239|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737240|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737241|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737242|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737243|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737244|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737245|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737246|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737247|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737248|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737249|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737250|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737254|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737255|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737256|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737257|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737258|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737259|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737260|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737261|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737262|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737263|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737264|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737265|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737266|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737267|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737268|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737269|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737270|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737271|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737272|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737273|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737274|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737275|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737276|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737277|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737278|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737279|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737280|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737281|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737282|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737283|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737284|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737285|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737286|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737287|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737288|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737289|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737290|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737291|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737292|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737293|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737294|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737295|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737296|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737297|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737298|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737299|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737300|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737301|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737302|NCT00106639|O1|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737303|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737304|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737305|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737306|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737307|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737308|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737309|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737310|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737311|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737312|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737313|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737314|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737315|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737316|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737317|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737318|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737319|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737320|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737321|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737322|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737323|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737324|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737325|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737326|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737327|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737328|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737329|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737330|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737331|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737332|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737333|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737334|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737335|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737336|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737337|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737338|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737339|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737340|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737341|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737342|NCT00106639|E3|Reported Event|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
737343|NCT00106639|E2|Reported Event|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
737344|NCT00106639|E1|Reported Event|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
737345|NCT00106626|B5|Baseline|Total|Total of all reporting groups
737346|NCT00106626|B4|Baseline|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
737347|NCT00106626|B3|Baseline|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
737348|NCT00106626|B2|Baseline|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
737349|NCT00106626|B1|Baseline|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
737350|NCT00106626|P4|Participant Flow|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
737351|NCT00106626|P3|Participant Flow|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
737352|NCT00106626|P2|Participant Flow|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
737353|NCT00106626|P1|Participant Flow|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
737354|NCT00106626|O4|Outcome|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
737355|NCT00106626|O3|Outcome|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
737356|NCT00106626|O2|Outcome|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
737357|NCT00106626|O1|Outcome|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
737358|NCT00106626|O9|Outcome|Dose Level D.2|(Cohort D) Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed
737359|NCT00106626|O8|Outcome|Dose Level D.1|(Cohort D) Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
737360|NCT00106626|O7|Outcome|Dose Level C.3|(Cohort C) Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed
737361|NCT00106626|O6|Outcome|Dose Level C.2|(Cohort C) Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
737362|NCT00106626|O5|Outcome|Dose Level C.1|(Cohort C) Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
737363|NCT00106626|O4|Outcome|Dose Level B.2|(Cohort B) Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
737364|NCT00106626|O3|Outcome|Dose Level B.1|(Cohort B) Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
737365|NCT00106626|O2|Outcome|Dose Level A.2|(Cohort A) Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin
737366|NCT00106626|O1|Outcome|Dose Level A.1|(Cohort A) Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
737367|NCT00106535|B4|Baseline|Total|Total of all reporting groups
737368|NCT00106535|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737369|NCT00106535|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737370|NCT00106535|B1|Baseline|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737371|NCT00106535|P4|Participant Flow|All Tocilizumab Exposure + MTX|All tocilizumab (TCZ) exposure + methotrexate (MTX) group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either Placebo, Tocilizumab 4 mg/kg or Tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received 8 mg/kg IV every 4 weeks.
737372|NCT00106535|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
737373|NCT00106535|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension (LTE) period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
737374|NCT00106535|P1|Participant Flow|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
737375|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737376|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737434|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737377|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737378|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737379|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737380|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737381|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737382|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737383|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737384|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737385|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737386|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737387|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737388|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737389|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737390|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737391|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737435|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
738741|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
737392|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
737393|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737394|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737395|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737396|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737397|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737398|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737399|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737400|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737401|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737402|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737403|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737404|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737405|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737406|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737407|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737408|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737409|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737410|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737411|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737412|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737413|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737414|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737415|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737416|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737417|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737418|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737419|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737420|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737421|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737422|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737423|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737424|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737425|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737426|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737427|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737428|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737429|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737430|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737431|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737432|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737433|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
738742|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
737436|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737437|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737438|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737439|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737440|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737441|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737442|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737443|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737444|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737445|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737446|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737447|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737448|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737449|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737450|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737451|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737452|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737453|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737454|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737455|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737456|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737457|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737458|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737459|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737460|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737461|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737462|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737463|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737464|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737465|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737466|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737467|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737468|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737469|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737470|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737471|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737472|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737473|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737474|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737475|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737476|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737477|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737478|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737479|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
751902|NCT00046891|O2|Outcome|Think Clearly|Self-report cognition
737480|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737481|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737482|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737483|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737484|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737485|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737486|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737487|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737488|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737489|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737490|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737491|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737492|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737493|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737494|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737495|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737496|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737497|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737498|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737499|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737500|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737501|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737502|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737503|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737504|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737505|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737506|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737507|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737508|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737509|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737510|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737511|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737512|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737513|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737514|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737515|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737516|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737517|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737518|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737519|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737520|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737521|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737522|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737523|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
738743|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
737524|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737525|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737526|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737527|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737528|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737529|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737530|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737531|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737532|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737533|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737534|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737535|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737536|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737537|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737538|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737539|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737540|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737541|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737542|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737543|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737544|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737545|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737546|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737547|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737548|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737549|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737550|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737551|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737552|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737553|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737554|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737555|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737556|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737557|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737558|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737559|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737560|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737561|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737562|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737563|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737564|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737565|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737566|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737567|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
738744|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
737568|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737569|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737570|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737571|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737572|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737573|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737574|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737575|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737576|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737577|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737578|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737579|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737580|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737581|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737582|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737583|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737584|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737585|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737586|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737587|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737588|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737589|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737590|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737591|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737592|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737593|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737594|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737595|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737596|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737597|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737598|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737599|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737600|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737601|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737602|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737603|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737604|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737605|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737606|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737607|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737608|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737609|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737610|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737611|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
751903|NCT00046891|O1|Outcome|Stay Focused|Self-report cognition
737612|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737613|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737614|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737615|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737616|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737617|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737618|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737619|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737620|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737621|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737622|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737623|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737624|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737625|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737626|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
737627|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737628|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737629|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
737630|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737631|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737632|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737633|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737634|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737635|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737636|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737637|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737638|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737639|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737640|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737641|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737642|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737643|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737644|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737645|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737646|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737647|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737648|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737649|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737650|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737651|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737652|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737653|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737654|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737655|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
738745|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
737656|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737657|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737658|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737659|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737660|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737661|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
737662|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
737663|NCT00106535|E3|Reported Event|All Tocilizumab 8 mg/kg + Methotrexate|"All participants who received tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 8mg + MTX = 3797.94 PY."
737664|NCT00106535|E2|Reported Event|All Tocilizumab 4 mg/kg + Methotrexate|"All participants who received tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 4mg + MTX = 580.99 PY."
737665|NCT00106535|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.~Total Exposure Placebo + MTX = 282.36 patient-years (PY)."
737666|NCT00106431|B1|Baseline|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737667|NCT00106431|P1|Participant Flow|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737668|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737669|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737670|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737671|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737672|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737673|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737674|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737675|NCT00106431|E1|Reported Event|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
737676|NCT00106392|B3|Baseline|Total|Total of all reporting groups
737677|NCT00106392|B2|Baseline|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737678|NCT00106392|B1|Baseline|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737679|NCT00106392|P2|Participant Flow|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737680|NCT00106392|P1|Participant Flow|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737681|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737682|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737901|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737683|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737684|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737685|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737686|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737687|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737688|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737689|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737690|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737691|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737692|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737693|NCT00106392|E2|Reported Event|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
737694|NCT00106392|E1|Reported Event|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
737695|NCT00106353|B3|Baseline|Total|Total of all reporting groups
737696|NCT00106353|B2|Baseline|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737697|NCT00106353|B1|Baseline|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
737698|NCT00106353|P7|Participant Flow|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737699|NCT00106353|P6|Participant Flow|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737700|NCT00106353|P5|Participant Flow|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737701|NCT00106353|P4|Participant Flow|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737702|NCT00106353|P3|Participant Flow|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737703|NCT00106353|P2|Participant Flow|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737704|NCT00106353|P1|Participant Flow|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligram per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737705|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737706|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
737707|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737708|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
737709|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737710|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737711|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737712|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737713|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737714|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
737715|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737716|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
738746|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
737717|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737718|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737719|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737720|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737721|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737722|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion..
737723|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737724|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737725|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737726|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737727|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737728|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737729|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737730|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737731|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737732|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737733|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737734|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737735|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737736|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737737|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737738|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737739|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737740|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737741|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737742|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737743|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737744|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737745|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737746|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737747|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737748|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737749|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737750|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737751|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737752|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737753|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
737754|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737755|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737756|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737757|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737758|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737759|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737760|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737761|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737762|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737763|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737764|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737765|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737766|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737767|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737768|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737769|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737770|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737771|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737772|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737773|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737774|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737775|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737776|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737777|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737778|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737779|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737780|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737781|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737782|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737783|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737784|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737785|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737786|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737787|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737788|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737789|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737790|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737791|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737792|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737793|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737794|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737795|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737796|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737797|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
738747|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
737798|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737799|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737800|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737801|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737802|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737803|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737804|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737805|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737806|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737807|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737808|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737809|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737810|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737811|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737812|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737813|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737814|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737815|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737816|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737817|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737818|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737819|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737820|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
737821|NCT00106353|E7|Reported Event|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737822|NCT00106353|E6|Reported Event|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737823|NCT00106353|E5|Reported Event|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
737824|NCT00106353|E4|Reported Event|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
737825|NCT00106353|E3|Reported Event|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
737826|NCT00106353|E2|Reported Event|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
737827|NCT00106353|E1|Reported Event|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
737828|NCT00106249|B3|Baseline|Total|Total of all reporting groups
737829|NCT00106249|B2|Baseline|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
737830|NCT00106249|B1|Baseline|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
737831|NCT00106249|P2|Participant Flow|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
737832|NCT00106249|P1|Participant Flow|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
737833|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
738748|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
737834|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
737835|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
737836|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
737837|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
737838|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
737839|NCT00106249|E2|Reported Event|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
737840|NCT00106249|E1|Reported Event|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
737841|NCT00106184|B3|Baseline|Total|Total of all reporting groups
737842|NCT00106184|B2|Baseline|Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
737843|NCT00106184|B1|Baseline|Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
737844|NCT00106184|P2|Participant Flow|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
737845|NCT00106184|P1|Participant Flow|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
737846|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
737847|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
737848|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
737849|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
737850|NCT00106184|O2|Outcome|Group B (Rituximab Wks 8 and 9)|"Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
737851|NCT00106184|O1|Outcome|Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
737852|NCT00106184|E2|Reported Event|Treatment Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
737853|NCT00106184|E1|Reported Event|Treatment Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
737854|NCT00106119|B1|Baseline|Entire Study Population|Includes groups randomized to receive Levothyroxine first and Liothyronine first.
737855|NCT00106119|P2|Participant Flow|Levothyroxine First, Then Liothyronine|Levothyroxine (dose of 5, 10, or 33 mcg) in first intervention period and Liothyronine (dose of 2.5, 10, or 16 mcg) in second intervention period (after washout period)
737856|NCT00106119|P1|Participant Flow|Liothyronine First, Then Levothyroxine|Liothyronine (dose of 2.5, 10, or 16 mcg) in first intervention period and Levothyroxine (dose of 5, 10, or 33 mcg) in second intervention period (after washout period)
738749|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
737857|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737858|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737859|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737860|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737861|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737862|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737863|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention ArmArm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737864|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737865|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737866|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737867|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737868|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737869|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737870|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
737871|NCT00106119|E2|Reported Event|Liothyronine Period|Patients at Liothyronine Period
737872|NCT00106119|E1|Reported Event|Levothyroxine Period|Patients at Levothyroxine Period
737873|NCT00106106|B3|Baseline|Total|Total of all reporting groups
737874|NCT00106106|B2|Baseline|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
737875|NCT00106106|B1|Baseline|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
737876|NCT00106106|P2|Participant Flow|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
737877|NCT00106106|P1|Participant Flow|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
737878|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
737879|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
737880|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
737881|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
737882|NCT00106106|E2|Reported Event|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
737883|NCT00106106|E1|Reported Event|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
737884|NCT00106080|B3|Baseline|Total|Total of all reporting groups
737885|NCT00106080|B2|Baseline|Control|Usual care
737886|NCT00106080|B1|Baseline|Intervention|Audit and feedback
737887|NCT00106080|P2|Participant Flow|Control (Usual Care)|We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers.
737888|NCT00106080|P1|Participant Flow|Intervention (Audit and Feedback)|We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers.
737889|NCT00106080|O2|Outcome|Control|Usual care
737890|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
737891|NCT00106080|O2|Outcome|Control|Usual care
737892|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
737893|NCT00106080|E2|Reported Event|Control|Usual care
737894|NCT00106080|E1|Reported Event|Intervention|Audit and Feedback
737895|NCT00106028|B3|Baseline|Total|Total of all reporting groups
737896|NCT00106028|B2|Baseline|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737897|NCT00106028|B1|Baseline|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737898|NCT00106028|P2|Participant Flow|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737899|NCT00106028|P1|Participant Flow|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737900|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737902|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737903|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737904|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737905|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737906|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737907|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737908|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737909|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737910|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737911|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737912|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737913|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737914|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737915|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737916|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737917|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737918|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737919|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737920|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737921|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737922|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737923|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737924|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737925|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737926|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737927|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737928|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737929|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737930|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737931|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737932|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737933|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737934|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737935|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737936|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737937|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737938|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737939|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737940|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737941|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737942|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737943|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737944|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737945|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737946|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737947|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737948|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737949|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737950|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
738750|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
737951|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737952|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737953|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737954|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737955|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737956|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737957|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737958|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737959|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737960|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737961|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737962|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737963|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737964|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737965|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737966|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737967|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737968|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737969|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737970|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737971|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737972|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737973|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737974|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737975|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737976|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737977|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737978|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737979|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737980|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737981|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737982|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737983|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737984|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737985|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737986|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737987|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737988|NCT00106028|E4|Reported Event|Years 2 & 3 Risedronate|Years 1-3 Risedronate, Double-Blind Year 1, Open-Label Years 2 & 3
737989|NCT00106028|E3|Reported Event|Years 2 & 3 Placebo-Risedronate|Year 1 Placebo Double-Blind, Years 2 & 3 Open-Label Risedronate
737990|NCT00106028|E2|Reported Event|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
737991|NCT00106028|E1|Reported Event|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
737992|NCT00106002|B1|Baseline|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
737993|NCT00106002|P1|Participant Flow|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
737994|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
737995|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
737996|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
737997|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
737998|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
737999|NCT00106002|E1|Reported Event|Pemetrexed|Pemetrexed
738000|NCT00105989|B1|Baseline|Duloxetine|duloxetine 60-120 mg QD
738751|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738001|NCT00105989|P2|Participant Flow|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738002|NCT00105989|P1|Participant Flow|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738003|NCT00105989|O3|Outcome|Duloxetine 120 mg|duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738004|NCT00105989|O2|Outcome|Duloxetine 90 mg|duloxetine 90 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738005|NCT00105989|O1|Outcome|Duloxetine 60 mg|duloxetine 60 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738006|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738007|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738008|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738009|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738010|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738011|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738012|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738013|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738014|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738015|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738016|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738017|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738018|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738019|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738020|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738021|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738022|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738023|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738024|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738025|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738026|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738027|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738028|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738029|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738030|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738031|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738032|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738033|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738034|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738035|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738036|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738037|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738038|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738039|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738040|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738041|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738042|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738043|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738044|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738045|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738046|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738047|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738048|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738049|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738050|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738051|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738052|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738053|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738054|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738055|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738056|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738057|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738058|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738059|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738060|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738061|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg QD
738062|NCT00105989|O1|Outcome|Duloxetine - Acute|duloxetine 60-120 mg QD
738063|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738064|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738065|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738066|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738067|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738068|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738069|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738070|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738071|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738072|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738073|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738074|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738075|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738076|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738077|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738078|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738079|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738080|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738081|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738082|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738083|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738084|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738085|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738086|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738087|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738088|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738089|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738090|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738091|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738092|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738093|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738094|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738095|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738096|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738097|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738098|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738099|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738100|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738101|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
738102|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
738103|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738104|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738105|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738106|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738107|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738108|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738109|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
738110|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
738111|NCT00105989|E4|Reported Event|Duloxetine 120 mg|Duloxetine 120 mg
738112|NCT00105989|E3|Reported Event|Duloxetine 90 mg|Duloxetine 90 mg
738113|NCT00105989|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg
738114|NCT00105989|E1|Reported Event|Placebo|Placebo
738115|NCT00105586|B3|Baseline|Total|Total of all reporting groups
738116|NCT00105586|B2|Baseline|Escitalopram|Participants will receive escitalopram.
738117|NCT00105586|B1|Baseline|Placebo|Participants will receive a placebo.
738118|NCT00105586|P2|Participant Flow|Escitalopram|Participants will receive escitalopram.
738119|NCT00105586|P1|Participant Flow|Placebo|Participants will receive a placebo.
738120|NCT00105586|O2|Outcome|Placebo (2)|"Placebo~Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
738121|NCT00105586|O1|Outcome|Escitalopram (1)|"Escitalopram~Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
738122|NCT00105586|O2|Outcome|Escitalopram|Participants will receive escitalopram.
738123|NCT00105586|O1|Outcome|Placebo|Participants will receive a placebo.
738124|NCT00105586|E2|Reported Event|Escitalopram|Participants will receive escitalopram.
738125|NCT00105586|E1|Reported Event|Placebo|Participants will receive a placebo.
738126|NCT00105560|B1|Baseline|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
738127|NCT00105560|P1|Participant Flow|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
738128|NCT00105560|O2|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
738129|NCT00105560|O1|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
738130|NCT00105560|O2|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
738131|NCT00105560|O1|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
738132|NCT00105560|O1|Outcome|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
738133|NCT00105560|O3|Outcome|Radiation Therapy - Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
738134|NCT00105560|O2|Outcome|Radiation Therapy - Standard Risk Group|radiation therapy: Radiation therapy with proton beam to standard doses
738135|NCT00105560|O1|Outcome|Radiation Therapy - Overall Study Population|radiation therapy: Radiation therapy with proton beam to standard doses
738136|NCT00105560|O3|Outcome|Radiation Therapy - Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
738137|NCT00105560|O2|Outcome|Radiation Therapy - Standard Risk Group|radiation therapy: Radiation therapy with proton beam to standard doses
738138|NCT00105560|O1|Outcome|Radiation Therapy - Overall Study Population|radiation therapy: Radiation therapy with proton beam to standard doses
738139|NCT00105560|O3|Outcome|Radiation Therapy Intermediate-High Risk|radiation therapy: Radiation therapy with proton beam to standard doses
738140|NCT00105560|O2|Outcome|Radiation Therapy - Standard Risk Group|radiation therapy: Radiation therapy with proton beam to standard doses
738141|NCT00105560|O1|Outcome|Radiation Therapy - Overall Study Population|radiation therapy: Radiation therapy with proton beam to standard doses
738142|NCT00105560|O3|Outcome|Radiation Therapy - 7 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
738143|NCT00105560|O2|Outcome|Radiation Therapy - 5 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
738752|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738144|NCT00105560|O1|Outcome|Radiation Therapy - 3 Years Follow-up|radiation therapy: Radiation therapy with proton beam to standard doses
738145|NCT00105560|E1|Reported Event|Radiation Therapy|radiation therapy: Radiation therapy with proton beam to standard doses
738146|NCT00105534|B3|Baseline|Total|Total of all reporting groups
738147|NCT00105534|B2|Baseline|Vehicle|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
738148|NCT00105534|B1|Baseline|AzaSite|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
738149|NCT00105534|P2|Participant Flow|Vehicle|
738150|NCT00105534|P1|Participant Flow|AzaSite|
738151|NCT00105534|O2|Outcome|Vehicle|
738152|NCT00105534|O1|Outcome|AzaSite|
738153|NCT00105534|O2|Outcome|Vehicle|
738154|NCT00105534|O1|Outcome|AzaSite|
738155|NCT00105534|E2|Reported Event|Vehicle|
738156|NCT00105534|E1|Reported Event|AzaSite|
738157|NCT00105521|B5|Baseline|Total|Total of all reporting groups
738158|NCT00105521|B4|Baseline|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
738159|NCT00105521|B3|Baseline|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
738160|NCT00105521|B2|Baseline|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
738161|NCT00105521|B1|Baseline|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
738162|NCT00105521|P4|Participant Flow|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
738163|NCT00105521|P3|Participant Flow|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
738164|NCT00105521|P2|Participant Flow|Sarizotan 2 mg/Day|Participants received sarizotan 2 milligrams per day (mg/day) (given in 2 divided daily doses) up to Week 12.
738165|NCT00105521|P1|Participant Flow|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
738166|NCT00105521|O4|Outcome|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
738167|NCT00105521|O3|Outcome|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
738168|NCT00105521|O2|Outcome|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
738169|NCT00105521|O1|Outcome|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
738170|NCT00105521|O4|Outcome|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
738171|NCT00105521|O3|Outcome|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
738172|NCT00105521|O2|Outcome|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
738173|NCT00105521|O1|Outcome|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
738174|NCT00105521|O4|Outcome|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
738175|NCT00105521|O3|Outcome|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
738176|NCT00105521|O2|Outcome|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
738177|NCT00105521|O1|Outcome|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
738178|NCT00105521|O4|Outcome|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
738179|NCT00105521|O3|Outcome|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
738180|NCT00105521|O2|Outcome|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
738181|NCT00105521|O1|Outcome|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
738182|NCT00105521|E4|Reported Event|Sarizotan 10 mg/Day|Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
738183|NCT00105521|E3|Reported Event|Sarizotan 4 mg/Day|Participants received sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
738184|NCT00105521|E2|Reported Event|Sarizotan 2 mg/Day|Participants received sarizotan 2 mg/day (given in 2 divided daily doses) up to Week 12.
738185|NCT00105521|E1|Reported Event|Placebo|Participants received placebo matched to sarizotan tablet orally twice daily up to Week 12.
738186|NCT00105482|B3|Baseline|Total|Total of all reporting groups
738187|NCT00105482|B2|Baseline|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738188|NCT00105482|B1|Baseline|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738320|NCT00105157|B2|Baseline|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738753|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738189|NCT00105482|P2|Participant Flow|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738190|NCT00105482|P1|Participant Flow|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738191|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738192|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738193|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738194|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738195|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738196|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738197|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738198|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738199|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738200|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738201|NCT00105482|E2|Reported Event|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738616|NCT00104650|P3|Participant Flow|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738202|NCT00105482|E1|Reported Event|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
738203|NCT00105469|B3|Baseline|Total|Total of all reporting groups
738204|NCT00105469|B2|Baseline|Tobramycin|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
738205|NCT00105469|B1|Baseline|AzaSite|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
738206|NCT00105469|P2|Participant Flow|Tobramycin|
738207|NCT00105469|P1|Participant Flow|AzaSite|
738208|NCT00105469|O2|Outcome|Tobramycin|
738209|NCT00105469|O1|Outcome|AzaSite|
738210|NCT00105469|O2|Outcome|Tobramycin|
738211|NCT00105469|O1|Outcome|AzaSite|
738212|NCT00105469|E2|Reported Event|Tobramycin|
738213|NCT00105469|E1|Reported Event|AzaSite|
738214|NCT00105443|B3|Baseline|Total|Total of all reporting groups
738215|NCT00105443|B2|Baseline|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738216|NCT00105443|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738217|NCT00105443|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section."
738218|NCT00105443|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section."
738219|NCT00105443|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
738220|NCT00105443|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
738221|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738222|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738223|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738224|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738225|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738226|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738227|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738735|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
738228|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738229|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738230|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738231|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738232|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738233|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738234|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738235|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738236|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738237|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738238|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738239|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
738240|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
738241|NCT00105443|E5|Reported Event|Subjects Switching From Placebo to Sorafenib (Open Label Only)|Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.
738242|NCT00105443|E4|Reported Event|Placebo Arm, Complete Double-Blind Phase|"Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
738243|NCT00105443|E3|Reported Event|Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)|Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
738244|NCT00105443|E2|Reported Event|Placebo Arm Double-Blind Phase (Interim Data Only)|"Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
738245|NCT00105443|E1|Reported Event|Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)|Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
738246|NCT00105235|B1|Baseline|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738247|NCT00105235|P1|Participant Flow|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738248|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738249|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738250|NCT00105235|O4|Outcome|Discontinued Immunosuppression Withdrawal|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738251|NCT00105235|O3|Outcome|Completed Withdrawal and Restarted Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738252|NCT00105235|O2|Outcome|Completed Withdrawal and Remains Off Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738269|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738344|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738253|NCT00105235|O1|Outcome|Withdrawal Never Started|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738254|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738255|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738256|NCT00105235|E1|Reported Event|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
738257|NCT00105196|B3|Baseline|Total|Total of all reporting groups
738258|NCT00105196|B2|Baseline|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738259|NCT00105196|B1|Baseline|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738260|NCT00105196|P2|Participant Flow|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738261|NCT00105196|P1|Participant Flow|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738262|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738263|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738264|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738265|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738266|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738267|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738268|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738918|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738270|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738271|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738272|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738273|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738274|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738275|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738276|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738277|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
738278|NCT00105196|E2|Reported Event|Placebo|
738279|NCT00105196|E1|Reported Event|Aripiprazole|
738280|NCT00105183|B4|Baseline|Total|Total of all reporting groups
738281|NCT00105183|B3|Baseline|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738282|NCT00105183|B2|Baseline|Placebo|USP 0.9% sodium chloride solution
738283|NCT00105183|B1|Baseline|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738284|NCT00105183|P3|Participant Flow|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738285|NCT00105183|P2|Participant Flow|Placebo|USP 0.9% sodium chloride solution
738286|NCT00105183|P1|Participant Flow|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738287|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738288|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738289|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738290|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738291|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738292|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738293|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738294|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738295|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738296|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738297|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738298|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738299|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738300|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738301|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738302|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738303|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738304|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738305|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738306|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738307|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738308|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738309|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738310|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738311|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738312|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
738313|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738314|NCT00105183|E3|Reported Event|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
738315|NCT00105183|E2|Reported Event|Placebo|USP 0.9% sodium chloride solution
738316|NCT00105183|E1|Reported Event|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
738317|NCT00105157|B5|Baseline|Total|Total of all reporting groups
738318|NCT00105157|B4|Baseline|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738319|NCT00105157|B3|Baseline|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738321|NCT00105157|B1|Baseline|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738322|NCT00105157|P4|Participant Flow|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738323|NCT00105157|P3|Participant Flow|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738324|NCT00105157|P2|Participant Flow|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738325|NCT00105157|P1|Participant Flow|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738326|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738327|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738328|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738329|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738330|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738331|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738332|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738333|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738334|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738335|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738336|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738337|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738338|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738339|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738340|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738341|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738342|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738343|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738919|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738345|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738346|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738347|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738348|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738349|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738350|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738351|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738352|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738353|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738354|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738355|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738356|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738357|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738358|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738359|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738360|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738361|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738362|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738363|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738364|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738365|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738366|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738367|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738736|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
738368|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738369|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738370|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738371|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738372|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738373|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738374|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738375|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738376|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738377|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738378|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738379|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738380|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738381|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738382|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738383|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738384|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738385|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738386|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738387|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738388|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738389|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738390|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738460|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738920|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738391|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738392|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738393|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738394|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738395|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738396|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738397|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738398|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738399|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738400|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738401|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738402|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738403|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738404|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738405|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738406|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738407|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738408|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738409|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738410|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738411|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738412|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738413|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738484|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738921|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738414|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738415|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738416|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738417|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738418|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738419|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738420|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738421|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738422|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738423|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738424|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738425|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738426|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738427|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738428|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738429|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738430|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738431|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738432|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738433|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738434|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738435|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738436|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738508|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738737|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
738437|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738438|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738439|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738440|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738441|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738442|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738443|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738444|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738445|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738446|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738447|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738448|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738449|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738450|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738451|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738452|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738453|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738454|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738455|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738456|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738457|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738458|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738459|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738545|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
738461|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738462|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738463|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738464|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738465|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738466|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738467|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738468|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738469|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738470|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738471|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738472|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738473|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738474|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738475|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738476|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738477|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738478|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738479|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738480|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738481|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738482|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738483|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738546|NCT00105066|E2|Reported Event|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
738485|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738486|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738487|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738488|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738489|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738490|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738491|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738492|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738493|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738494|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738495|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738496|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738497|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738498|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738499|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738500|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738501|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738502|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738503|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738504|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738505|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738506|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738507|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738547|NCT00105066|E1|Reported Event|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
738509|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738510|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738511|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738512|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
738513|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738514|NCT00105157|E2|Reported Event|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
738515|NCT00105157|E1|Reported Event|MK0518|Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d.
738516|NCT00105079|B3|Baseline|Total|Total of all reporting groups
738517|NCT00105079|B2|Baseline|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738518|NCT00105079|B1|Baseline|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738519|NCT00105079|P2|Participant Flow|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738520|NCT00105079|P1|Participant Flow|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738521|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738522|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738523|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738524|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738525|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738526|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738527|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738528|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738529|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738530|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738531|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738532|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738533|NCT00105079|E2|Reported Event|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738534|NCT00105079|E1|Reported Event|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
738535|NCT00105066|B3|Baseline|Total|Total of all reporting groups
738536|NCT00105066|B2|Baseline|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
738537|NCT00105066|B1|Baseline|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
738538|NCT00105066|P2|Participant Flow|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
738539|NCT00105066|P1|Participant Flow|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
738540|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
738541|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
738542|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
738543|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
738544|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
738548|NCT00105027|B7|Baseline|Total|Total of all reporting groups
738549|NCT00105027|B6|Baseline|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738550|NCT00105027|B5|Baseline|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738551|NCT00105027|B4|Baseline|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
738552|NCT00105027|B3|Baseline|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738553|NCT00105027|B2|Baseline|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738554|NCT00105027|B1|Baseline|CRVO Observation|Standard care consists of observation of the macular edema.
738555|NCT00105027|P6|Participant Flow|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738556|NCT00105027|P5|Participant Flow|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738557|NCT00105027|P4|Participant Flow|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
738558|NCT00105027|P3|Participant Flow|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738559|NCT00105027|P2|Participant Flow|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738560|NCT00105027|P1|Participant Flow|CRVO Observation|Standard care consists of observation of the macular edema.
738561|NCT00105027|O6|Outcome|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738562|NCT00105027|O5|Outcome|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738563|NCT00105027|O4|Outcome|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
738564|NCT00105027|O3|Outcome|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738565|NCT00105027|O2|Outcome|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738566|NCT00105027|O1|Outcome|CRVO Observation|Standard care consists of observation of the macular edema.
738738|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
738567|NCT00105027|E6|Reported Event|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738568|NCT00105027|E5|Reported Event|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738569|NCT00105027|E4|Reported Event|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
738570|NCT00105027|E3|Reported Event|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738571|NCT00105027|E2|Reported Event|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
738572|NCT00105027|E1|Reported Event|CRVO Observation|Standard care consists of observation of the macular edema.
738573|NCT00105001|B4|Baseline|Total|Total of all reporting groups
738574|NCT00105001|B3|Baseline|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738575|NCT00105001|B2|Baseline|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738576|NCT00105001|B1|Baseline|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738577|NCT00105001|P3|Participant Flow|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and Mycophenolate Mofetil [MMF] as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738578|NCT00105001|P2|Participant Flow|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738579|NCT00105001|P1|Participant Flow|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738580|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738611|NCT00104728|E1|Reported Event|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
738581|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738582|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738583|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738584|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738585|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738586|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738587|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738588|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738589|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738590|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738591|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738612|NCT00104650|B4|Baseline|Total|Total of all reporting groups
738613|NCT00104650|B3|Baseline|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738614|NCT00104650|B2|Baseline|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738592|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738593|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738594|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738595|NCT00105001|E3|Reported Event|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
738596|NCT00105001|E2|Reported Event|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738597|NCT00105001|E1|Reported Event|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
738598|NCT00104884|B1|Baseline|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
738599|NCT00104884|P1|Participant Flow|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
738600|NCT00104884|O1|Outcome|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
738601|NCT00104884|E1|Reported Event|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
738602|NCT00104871|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
738603|NCT00104871|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
738604|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
738605|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
738606|NCT00104871|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
738607|NCT00104728|B1|Baseline|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
738608|NCT00104728|P1|Participant Flow|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
738609|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
738610|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
738615|NCT00104650|B1|Baseline|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738617|NCT00104650|P2|Participant Flow|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738618|NCT00104650|P1|Participant Flow|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738619|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738620|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738621|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738622|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738623|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738624|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738625|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738626|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738627|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738628|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738629|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738630|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738631|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738632|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738633|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738634|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738635|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738636|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738637|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738638|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738639|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738640|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738641|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738642|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738643|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
738644|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
738645|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
738646|NCT00104650|E3|Reported Event|Denosumab 180 mg Q4W|
738647|NCT00104650|E2|Reported Event|Denosumab 180 mg Q12W|
738648|NCT00104650|E1|Reported Event|Bisphosphonate IV Q4W|
738649|NCT00104637|B1|Baseline|Randomized Participants|All enrolled and randomized participants who were administered 25 mg Sildenafil and 25mg placebo at 2 different time periods.
738650|NCT00104637|P2|Participant Flow|Placebo /Sildenafil|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
738651|NCT00104637|P1|Participant Flow|Sildenafil /Placebo|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
738652|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738653|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
738654|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738655|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
738656|NCT00104637|O2|Outcome|Placebo|Participants that received Placebo
738657|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
738658|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738659|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
738660|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738661|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
738662|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738663|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
738664|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738665|NCT00104637|O1|Outcome|Sildenafil|Group that received Sildenafil
738666|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738667|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
738668|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738669|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
738670|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738671|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
738672|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
738673|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
738674|NCT00104637|E2|Reported Event|Placebo|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
738675|NCT00104637|E1|Reported Event|Sildenafil|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
738676|NCT00104572|B4|Baseline|Total|Total of all reporting groups
738677|NCT00104572|B3|Baseline|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738678|NCT00104572|B2|Baseline|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738679|NCT00104572|B1|Baseline|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738680|NCT00104572|P3|Participant Flow|Placebo|"9 participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738681|NCT00104572|P2|Participant Flow|Aromatase Inhibitor|"13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738682|NCT00104572|P1|Participant Flow|Transdermal Testosterone|"13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738683|NCT00104572|O3|Outcome|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738684|NCT00104572|O2|Outcome|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738685|NCT00104572|O1|Outcome|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738686|NCT00104572|E3|Reported Event|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738687|NCT00104572|E2|Reported Event|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738688|NCT00104572|E1|Reported Event|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
738689|NCT00104520|B3|Baseline|Total|Total of all reporting groups
738690|NCT00104520|B2|Baseline|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738691|NCT00104520|B1|Baseline|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738692|NCT00104520|P2|Participant Flow|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738693|NCT00104520|P1|Participant Flow|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738694|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738695|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738696|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738697|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738698|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738739|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
738699|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738700|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738701|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738702|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738703|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738704|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738705|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738706|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738707|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738708|NCT00104520|E2|Reported Event|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738709|NCT00104520|E1|Reported Event|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
738710|NCT00104416|B3|Baseline|Total|Total of all reporting groups
738711|NCT00104416|B2|Baseline|Double-Blind Phase: LTG XR|LTG XR once daily
738712|NCT00104416|B1|Baseline|Double-Blind Phase: Placebo|Control - matching placebo once daily
738713|NCT00104416|P5|Participant Flow|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
738714|NCT00104416|P4|Participant Flow|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
738715|NCT00104416|P3|Participant Flow|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
738716|NCT00104416|P2|Participant Flow|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
738717|NCT00104416|P1|Participant Flow|Double-Blind Phase: Placebo|Control - matching placebo once daily
738718|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738719|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738720|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738721|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738722|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738723|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738724|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738725|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738726|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738727|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738728|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738729|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738730|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738731|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738732|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
738733|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
738734|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
738754|NCT00104416|E5|Reported Event|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
738755|NCT00104416|E4|Reported Event|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
738756|NCT00104416|E3|Reported Event|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
738757|NCT00104416|E2|Reported Event|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
738758|NCT00104416|E1|Reported Event|Double-Blind Phase: Placebo|Control - matching placebo once daily
738759|NCT00104299|B3|Baseline|Total|Total of all reporting groups
738760|NCT00104299|B2|Baseline|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738761|NCT00104299|B1|Baseline|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738762|NCT00104299|P2|Participant Flow|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738763|NCT00104299|P1|Participant Flow|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738764|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738765|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738766|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738767|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738768|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738769|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738770|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738771|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738772|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738773|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738774|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738775|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738776|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738777|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738778|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
738779|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
738922|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738780|NCT00104299|E2|Reported Event|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
738781|NCT00104299|E1|Reported Event|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
738782|NCT00104247|B3|Baseline|Total|Total of all reporting groups
738783|NCT00104247|B2|Baseline|Placebo|Placebo
738784|NCT00104247|B1|Baseline|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
738785|NCT00104247|P2|Participant Flow|Placebo|Placebo
738786|NCT00104247|P1|Participant Flow|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
738787|NCT00104247|O2|Outcome|Placebo|Placebo
738788|NCT00104247|O1|Outcome|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
738789|NCT00104247|E2|Reported Event|Placebo|Placebo
738790|NCT00104247|E1|Reported Event|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
738791|NCT00104234|B3|Baseline|Total|Total of all reporting groups
738792|NCT00104234|B2|Baseline|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
738793|NCT00104234|B1|Baseline|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
738794|NCT00104234|P2|Participant Flow|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
738795|NCT00104234|P1|Participant Flow|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
738796|NCT00104234|O1|Outcome|All Participants (N=37)|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
738797|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
738798|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
738799|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
738800|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
738801|NCT00104234|E1|Reported Event|All Participants|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
738802|NCT00104104|B3|Baseline|Total|Total of all reporting groups
738803|NCT00104104|B2|Baseline|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738804|NCT00104104|B1|Baseline|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738805|NCT00104104|P2|Participant Flow|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738806|NCT00104104|P1|Participant Flow|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738807|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738808|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738809|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738810|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738811|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738812|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738813|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738923|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738814|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738815|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738816|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738817|NCT00104104|E2|Reported Event|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
738818|NCT00104104|E1|Reported Event|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
738819|NCT00104052|B1|Baseline|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
738820|NCT00104052|P1|Participant Flow|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
738821|NCT00104052|O1|Outcome|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
738822|NCT00104052|E1|Reported Event|PEG-Intron Plus REBETOL|
738823|NCT00103857|B8|Baseline|Total|Total of all reporting groups
738824|NCT00103857|B7|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
738825|NCT00103857|B6|Baseline|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738826|NCT00103857|B5|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738827|NCT00103857|B4|Baseline|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738828|NCT00103857|B3|Baseline|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738924|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738925|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738926|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738927|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738829|NCT00103857|B2|Baseline|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738830|NCT00103857|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738831|NCT00103857|P7|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
738832|NCT00103857|P6|Participant Flow|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738833|NCT00103857|P5|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738834|NCT00103857|P4|Participant Flow|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738835|NCT00103857|P3|Participant Flow|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738836|NCT00103857|P2|Participant Flow|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738837|NCT00103857|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738928|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738929|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738930|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738931|NCT00103844|E2|Reported Event|IMATINIB|Imatinib 400 mg BID
738838|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738839|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738840|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738841|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738842|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738843|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738844|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738845|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738846|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738932|NCT00103844|E1|Reported Event|DASATINIB|Dasatinib 70 mg twice a day (BID)
738933|NCT00103740|B3|Baseline|Total|Total of all reporting groups
739087|NCT00103116|E1|Reported Event|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
738847|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738848|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738849|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738850|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738851|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738852|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738853|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738854|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738855|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738934|NCT00103740|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
739088|NCT00103012|B4|Baseline|Total|Total of all reporting groups
739234|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
738856|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738857|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738858|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738859|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738860|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738861|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738862|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738863|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738864|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738935|NCT00103740|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
739235|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
738865|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738866|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738867|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738868|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738869|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738870|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738871|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738872|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738873|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738936|NCT00103740|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
739116|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
738874|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738875|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738876|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738877|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738878|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738879|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738880|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738881|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738882|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738937|NCT00103740|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
739236|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
738883|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738884|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738885|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738886|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738887|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738888|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738889|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738890|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738891|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738938|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
739156|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
738892|NCT00103857|E7|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
738893|NCT00103857|E6|Reported Event|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
738894|NCT00103857|E5|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738895|NCT00103857|E4|Reported Event|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738896|NCT00103857|E3|Reported Event|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738897|NCT00103857|E2|Reported Event|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
738898|NCT00103857|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
738899|NCT00103844|B3|Baseline|Total|Total of all reporting groups
738900|NCT00103844|B2|Baseline|Imatinib|Imatinib 400 mg BID
738901|NCT00103844|B1|Baseline|Dasatinib|Dasatinib 70 mg twice a day (BID)
738902|NCT00103844|P2|Participant Flow|Imatinib First|Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).
738903|NCT00103844|P1|Participant Flow|Dasatinib First|Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period).
738904|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738905|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738906|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738907|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738908|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738909|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738910|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738911|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738912|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738913|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738914|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738915|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738916|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
738917|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
738939|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738940|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738941|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738942|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738943|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738944|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738945|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738946|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738947|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738948|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738949|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738950|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738951|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738952|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738953|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738954|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738955|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738956|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738957|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738958|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738959|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738960|NCT00103740|E2|Reported Event|Risedronate|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738961|NCT00103740|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
738962|NCT00103662|B3|Baseline|Total|Total of all reporting groups
738963|NCT00103662|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738964|NCT00103662|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738965|NCT00103662|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738966|NCT00103662|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738967|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738968|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738969|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738970|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738971|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738972|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738973|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738974|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738975|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738976|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738977|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738978|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738979|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
739157|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
752484|NCT00033293|B3|Baseline|Total|Total of all reporting groups
738980|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738981|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738982|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738983|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738984|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738985|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738986|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738987|NCT00103662|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738988|NCT00103662|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
738989|NCT00103610|B3|Baseline|Total|Total of all reporting groups
738990|NCT00103610|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738991|NCT00103610|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738992|NCT00103610|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738993|NCT00103610|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738994|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738995|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738996|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738997|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738998|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
738999|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
741054|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
739000|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739001|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739002|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739003|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739004|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739005|NCT00103610|O1|Outcome|G-CSF + Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739006|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739007|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739008|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739009|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739010|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739011|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739012|NCT00103610|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739013|NCT00103610|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
739014|NCT00103506|B3|Baseline|Total|Total of all reporting groups
739015|NCT00103506|B2|Baseline|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
739016|NCT00103506|B1|Baseline|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
739017|NCT00103506|P2|Participant Flow|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
739018|NCT00103506|P1|Participant Flow|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
739019|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
739020|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
741055|NCT00096031|E1|Reported Event|Cetuximab|
739021|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
739022|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
739023|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
739024|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
739025|NCT00103506|E2|Reported Event|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
739026|NCT00103506|E1|Reported Event|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
739027|NCT00103311|B3|Baseline|Total|Total of all reporting groups
739028|NCT00103311|B2|Baseline|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739029|NCT00103311|B1|Baseline|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739030|NCT00103311|P2|Participant Flow|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739031|NCT00103311|P1|Participant Flow|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739032|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739033|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739034|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739035|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739036|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739037|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739038|NCT00103311|E2|Reported Event|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739039|NCT00103311|E1|Reported Event|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
739040|NCT00103259|B3|Baseline|Total|Total of all reporting groups
739041|NCT00103259|B2|Baseline|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
739042|NCT00103259|B1|Baseline|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739043|NCT00103259|P2|Participant Flow|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
739044|NCT00103259|P1|Participant Flow|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739045|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
739046|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739047|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
739048|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739049|NCT00103259|O1|Outcome|Cross-over From Bortezomib to Combined Arm|Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.
739050|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
739051|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739052|NCT00103259|E3|Reported Event|Cross-over Patients|11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
739053|NCT00103259|E2|Reported Event|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
739054|NCT00103259|E1|Reported Event|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739055|NCT00103207|B1|Baseline|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
739056|NCT00103207|P1|Participant Flow|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
739057|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
739058|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
739059|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
739060|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
739061|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
739062|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
739063|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
739064|NCT00103207|E1|Reported Event|Cetuximab|All treated patients were evaluated for toxicities.
739065|NCT00103194|B1|Baseline|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
739066|NCT00103194|P1|Participant Flow|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
739067|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
739068|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
739069|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
739070|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
739071|NCT00103194|E1|Reported Event|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
739072|NCT00103142|B3|Baseline|Total|Total of all reporting groups
739073|NCT00103142|B2|Baseline|Experimental PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (Granulocyte-macrophage colony-stimulating factor or GM-CSF) subcutaneous (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
739074|NCT00103142|B1|Baseline|Experimental PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-Carcinoembryonic antigen (CEA)-Mucin 1 (MUC-1)-TRIad of COstimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneous (SC) and intradermally (ID) on days 28, 56, and 84.
739075|NCT00103142|P2|Participant Flow|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
739076|NCT00103142|P1|Participant Flow|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
739077|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
739078|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
739079|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
739080|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-carcinoembryonic antigen (CEA)- mucin 1 (MUC-1)-TRiad of Costimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
739081|NCT00103142|E2|Reported Event|Arm II|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
739082|NCT00103142|E1|Reported Event|Arm I|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
739083|NCT00103116|B1|Baseline|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
739084|NCT00103116|P1|Participant Flow|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
739085|NCT00103116|O1|Outcome|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
739086|NCT00103116|O1|Outcome|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
739089|NCT00103012|B3|Baseline|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
739090|NCT00103012|B2|Baseline|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
739091|NCT00103012|B1|Baseline|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
739092|NCT00103012|P3|Participant Flow|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
739093|NCT00103012|P2|Participant Flow|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
739094|NCT00103012|P1|Participant Flow|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
739095|NCT00103012|O3|Outcome|Influence of Panax Ginseng on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
739096|NCT00103012|O2|Outcome|Influence of Echinacea on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14 days of Echinacea purpurea administration (500 mg three times daily) to healthy human volunteers.
739097|NCT00103012|O1|Outcome|Influence of Ginkgo Biloba on Lopinavir Disposition|Lopinavir pharmacokinetics (administered as lopinavir-ritonavir X 2 weeks) determined before, and after 14 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
739098|NCT00103012|E3|Reported Event|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
739099|NCT00103012|E2|Reported Event|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
739100|NCT00103012|E1|Reported Event|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
739101|NCT00102804|B3|Baseline|Total|Total of all reporting groups
739102|NCT00102804|B2|Baseline|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739103|NCT00102804|B1|Baseline|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739104|NCT00102804|P2|Participant Flow|Placebo and BSC|"Placebo: IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739105|NCT00102804|P1|Participant Flow|Pemetrexed and BSC|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression.~Best Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739106|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739107|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739108|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739109|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739110|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739111|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739112|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739113|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739114|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739115|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
741056|NCT00096018|B3|Baseline|Total|Total of all reporting groups
739117|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739118|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739119|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739120|NCT00102804|E2|Reported Event|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739121|NCT00102804|E1|Reported Event|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
739122|NCT00102687|B4|Baseline|Total|Total of all reporting groups
739123|NCT00102687|B3|Baseline|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739124|NCT00102687|B2|Baseline|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739125|NCT00102687|B1|Baseline|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739126|NCT00102687|P5|Participant Flow|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
739127|NCT00102687|P4|Participant Flow|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
739128|NCT00102687|P3|Participant Flow|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739129|NCT00102687|P2|Participant Flow|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739130|NCT00102687|P1|Participant Flow|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739131|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
739132|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
739133|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
739134|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739135|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739136|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739137|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
739138|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
739139|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
739140|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
739141|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
739142|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
739143|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739144|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739145|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739146|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739147|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739148|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739149|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their treatment assigned during the initial study period through month 7 to month 23.
739150|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
739151|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
739152|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739153|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739154|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739155|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
753117|NCT00009945|B3|Baseline|Total|Total of all reporting groups
739158|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
739159|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
739160|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
739161|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739162|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739163|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739164|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739165|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739166|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739167|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
739168|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
739169|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
739170|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
739171|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
739172|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
739173|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739174|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739175|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739176|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739177|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739178|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739179|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739180|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739181|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739182|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739183|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739184|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739185|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739186|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739187|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739188|NCT00102687|E5|Reported Event|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
739189|NCT00102687|E4|Reported Event|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
739190|NCT00102687|E3|Reported Event|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
739191|NCT00102687|E2|Reported Event|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
739192|NCT00102687|E1|Reported Event|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
739193|NCT00102596|B1|Baseline|All Participants|Baseline is included for all participants who passed screening and received at least 1 dose of 1-octanol, whether in Part A, B or C
739194|NCT00102596|P2|Participant Flow|Part B Then C: Fixed Dose|"In Part B, subjects fasted overnight for 6 hours and received 64 mg/kg 1-octanol at 6AM of both formulations:~1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; or 2) a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).~At the completion of Parts A and B, an exploratory Part C was added in which subjects fasted overnight for 6 hours and received 128 mg/kg 1-octanol at 6AM of both formulations."
739231|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739232|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739233|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739195|NCT00102596|P1|Participant Flow|Part A: Dose Escalation|"Subjects fasted overnight for 6 hours and received 1, 4, 8, 16, 32 and 64 mg/kg 1-octanol at 6AM on different days. There were 2 formulations:~1) 2 participants received 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; and 2) two participants received a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA)."
739196|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
739197|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of the 1-octanol
739198|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
739199|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
739200|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
739201|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
739202|NCT00102596|E1|Reported Event|1-octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
739203|NCT00102531|B3|Baseline|Total|Total of all reporting groups
739204|NCT00102531|B2|Baseline|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2~Cisplatin liposomal"
739205|NCT00102531|B1|Baseline|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.~Cisplatin liposomal"
739206|NCT00102531|P2|Participant Flow|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2~Cisplatin liposomal"
739207|NCT00102531|P1|Participant Flow|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.~Cisplatin liposomal"
739208|NCT00102531|O2|Outcome|Cisplatin Liposomal 36 mg/m2|The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
739209|NCT00102531|O1|Outcome|Cisplatin Liposomal 24 mg/m2|Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation
739210|NCT00102531|E2|Reported Event|Cisplatin Liposomal 36 mg/m2|"The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2~Cisplatin liposomal"
739211|NCT00102531|E1|Reported Event|Cisplatin Liposomal 24 mg/m2|"Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.~Cisplatin liposomal"
739212|NCT00102518|B1|Baseline|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
739213|NCT00102518|P1|Participant Flow|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
739214|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
739215|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
739216|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
739217|NCT00102518|E1|Reported Event|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
739218|NCT00102440|B4|Baseline|Total|Total of all reporting groups
739219|NCT00102440|B3|Baseline|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739220|NCT00102440|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739221|NCT00102440|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739222|NCT00102440|P3|Participant Flow|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739223|NCT00102440|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739224|NCT00102440|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739225|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739226|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739227|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739228|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739229|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739230|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
753118|NCT00009945|B2|Baseline|Placebo|Placebo
739237|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739238|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739239|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739240|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739241|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739242|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739243|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739244|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739245|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739246|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739247|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739248|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739249|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739250|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739251|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739252|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739253|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739254|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739255|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739256|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739257|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739258|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739259|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739260|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739261|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739262|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739263|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739264|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739265|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739266|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739267|NCT00102440|E3|Reported Event|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
739268|NCT00102440|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
739269|NCT00102440|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
739270|NCT00102063|B4|Baseline|Total|Total of all reporting groups
739271|NCT00102063|B3|Baseline|Placebo Group|Participants were given a single pill administered once daily
739272|NCT00102063|B2|Baseline|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739273|NCT00102063|B1|Baseline|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739274|NCT00102063|P3|Participant Flow|Placebo Group|Participants were given a single pill administered once daily
739275|NCT00102063|P2|Participant Flow|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739276|NCT00102063|P1|Participant Flow|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739277|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739278|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739279|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739280|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739281|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739282|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739283|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739318|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
753119|NCT00009945|B1|Baseline|Clodronate|Clodronate
739284|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739285|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739286|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739287|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739288|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739289|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739290|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739291|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739292|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739293|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739294|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739295|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739296|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739297|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739298|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
739299|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739300|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739301|NCT00102063|E3|Reported Event|Placebo Group|Participants were given a single pill administered once daily
739302|NCT00102063|E2|Reported Event|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
739303|NCT00102063|E1|Reported Event|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
739304|NCT00101933|B3|Baseline|Total|Total of all reporting groups
739305|NCT00101933|B2|Baseline|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739306|NCT00101933|B1|Baseline|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739307|NCT00101933|P2|Participant Flow|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739308|NCT00101933|P1|Participant Flow|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739309|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739310|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739311|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739312|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739313|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739314|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739315|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739316|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739317|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739378|NCT00101868|B3|Baseline|Total|Total of all reporting groups
739319|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739320|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739321|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
739322|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
739323|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739324|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739325|NCT00101933|E2|Reported Event|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
739326|NCT00101933|E1|Reported Event|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
739327|NCT00101907|B7|Baseline|Total|Total of all reporting groups
739328|NCT00101907|B6|Baseline|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739329|NCT00101907|B5|Baseline|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739330|NCT00101907|B4|Baseline|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739331|NCT00101907|B3|Baseline|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739332|NCT00101907|B2|Baseline|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739333|NCT00101907|B1|Baseline|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
739334|NCT00101907|P6|Participant Flow|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739335|NCT00101907|P5|Participant Flow|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739336|NCT00101907|P4|Participant Flow|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739337|NCT00101907|P3|Participant Flow|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739338|NCT00101907|P2|Participant Flow|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739339|NCT00101907|P1|Participant Flow|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
739340|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739341|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739342|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739343|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739344|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739345|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
739346|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739347|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739348|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739349|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
755834|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
739350|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739351|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739352|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739353|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739354|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739355|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739356|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739357|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739358|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739359|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739360|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739361|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739362|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739363|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739364|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739365|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739366|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739367|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739368|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739369|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739370|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739371|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
739372|NCT00101907|E6|Reported Event|75 mg BID AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739373|NCT00101907|E5|Reported Event|125 mg QD AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739374|NCT00101907|E4|Reported Event|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739375|NCT00101907|E3|Reported Event|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739376|NCT00101907|E2|Reported Event|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
739377|NCT00101907|E1|Reported Event|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
739379|NCT00101868|B2|Baseline|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
739380|NCT00101868|B1|Baseline|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
739381|NCT00101868|P2|Participant Flow|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
739382|NCT00101868|P1|Participant Flow|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
739383|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
739384|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
739385|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
739386|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
739387|NCT00101868|O2|Outcome|Usual Care Discharge, Handwritten|The control intervention was the usual care discharge process. Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post-discharge activities and restrictions, post-discharge diet, post-discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, 1 page of which also included medication instructions and prescriptions.
739388|NCT00101868|O1|Outcome|Discharge Software|Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
739389|NCT00101868|E2|Reported Event|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
739390|NCT00101868|E1|Reported Event|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
739391|NCT00101816|B3|Baseline|Total|Total of all reporting groups
739453|NCT00101686|P9|Participant Flow|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
739392|NCT00101816|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739393|NCT00101816|B1|Baseline|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739394|NCT00101816|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739395|NCT00101816|P1|Participant Flow|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739396|NCT00101816|O3|Outcome|Total|
739397|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739398|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739399|NCT00101816|O2|Outcome|Study Day 8|
739400|NCT00101816|O1|Outcome|Study Day 1|
739401|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739402|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739403|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739454|NCT00101686|P8|Participant Flow|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
739404|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739405|NCT00101816|O2|Outcome|Study Day 8|
739406|NCT00101816|O1|Outcome|Study Day 1|
739407|NCT00101816|O2|Outcome|Study Day 8|
739408|NCT00101816|O1|Outcome|Study Day 1|
739409|NCT00101816|O2|Outcome|Study Day 8|
739410|NCT00101816|O1|Outcome|Study Day 1|
739411|NCT00101816|O2|Outcome|Study Day 8|
739412|NCT00101816|O1|Outcome|Study Day 1|
739413|NCT00101816|O2|Outcome|Study Day 8|
739414|NCT00101816|O1|Outcome|Study Day 1|
739415|NCT00101816|O3|Outcome|Total|
739416|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739417|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739418|NCT00101816|O3|Outcome|Total|
739419|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739420|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739421|NCT00101816|O2|Outcome|MCyR|Participants acheiving MCyR, defined as the rate of CCyR plus the rate of Partial Cytogenetic Response
739422|NCT00101816|O1|Outcome|MaHR|Participants acheiving MaHR, defined as best confirmed response of Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL) of Minore Hematologic Response (MiHR)
739423|NCT00101816|O3|Outcome|Total|
739424|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739425|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739426|NCT00101816|O3|Outcome|Total|
739427|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739629|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
739428|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739429|NCT00101816|O3|Outcome|Total|
739430|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739431|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739432|NCT00101816|O2|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response (MaHR or MiHR).
739433|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
739434|NCT00101816|O1|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response
739435|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
739436|NCT00101816|O3|Outcome|Total|
739437|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739438|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739439|NCT00101816|E2|Reported Event|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
739440|NCT00101816|E1|Reported Event|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
739441|NCT00101686|B11|Baseline|Total|Total of all reporting groups
739442|NCT00101686|B10|Baseline|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
739443|NCT00101686|B9|Baseline|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
739444|NCT00101686|B8|Baseline|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
739445|NCT00101686|B7|Baseline|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
739446|NCT00101686|B6|Baseline|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
739447|NCT00101686|B5|Baseline|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
739448|NCT00101686|B4|Baseline|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
739449|NCT00101686|B3|Baseline|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
739450|NCT00101686|B2|Baseline|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
739451|NCT00101686|B1|Baseline|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
739452|NCT00101686|P10|Participant Flow|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
739455|NCT00101686|P7|Participant Flow|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
739456|NCT00101686|P6|Participant Flow|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
739457|NCT00101686|P5|Participant Flow|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
739458|NCT00101686|P4|Participant Flow|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
739459|NCT00101686|P3|Participant Flow|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
739460|NCT00101686|P2|Participant Flow|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
739461|NCT00101686|P1|Participant Flow|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
739462|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
739463|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
739464|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
739465|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739466|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739467|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
739468|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
739469|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
739470|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739471|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739472|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
739473|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
739474|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
739475|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
739476|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
739477|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
739478|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
739479|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
739480|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
739481|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
739482|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
739483|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
739484|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
739485|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
739486|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
739487|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739488|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739489|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
739490|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739491|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739492|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
739493|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739494|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739495|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
739496|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739497|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739498|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739499|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739500|NCT00101686|E5|Reported Event|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
739501|NCT00101686|E4|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
739502|NCT00101686|E3|Reported Event|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
739503|NCT00101686|E2|Reported Event|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
739504|NCT00101686|E1|Reported Event|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
739505|NCT00101660|B3|Baseline|Total|Total of all reporting groups
739582|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739583|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739585|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739506|NCT00101660|B2|Baseline|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
739507|NCT00101660|B1|Baseline|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
739508|NCT00101660|P2|Participant Flow|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
739509|NCT00101660|P1|Participant Flow|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
739510|NCT00101660|O1|Outcome|Dasatinib|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739511|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|"Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.~a"
739512|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739513|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739514|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739515|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739516|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739517|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739518|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739519|NCT00101660|O1|Outcome|Dasatanib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739520|NCT00101660|O1|Outcome|Dastinib, 70 mg, BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739521|NCT00101660|O1|Outcome|Dasatinib, 70 mg, Twice Daily (BID)|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
739522|NCT00101660|E2|Reported Event|Resistant|
739523|NCT00101660|E1|Reported Event|Intolerant|
739524|NCT00101647|B3|Baseline|Total|Total of all reporting groups
739525|NCT00101647|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
739526|NCT00101647|B1|Baseline|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
739584|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739627|NCT00101413|P1|Participant Flow|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
739527|NCT00101647|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
739528|NCT00101647|P1|Participant Flow|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
739529|NCT00101647|O3|Outcome|Total|
739530|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739531|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739532|NCT00101647|O2|Outcome|Day 8|
739533|NCT00101647|O1|Outcome|Day 1|
739534|NCT00101647|O2|Outcome|Day 8|
739535|NCT00101647|O1|Outcome|Day 1|
739536|NCT00101647|O2|Outcome|Day 8|
739537|NCT00101647|O1|Outcome|Day 1|
739538|NCT00101647|O2|Outcome|Study Day 8|
739539|NCT00101647|O1|Outcome|Study Day 1|
739540|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739541|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
739542|NCT00101647|O3|Outcome|Total|
739543|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739544|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739545|NCT00101647|O2|Outcome|Participants Achieving MCyR|Percentage of participants achieving major cytogenetic response (MCyR), defined as the rate of complete cytogenetic response (CCyR) plus the rate of partial cytogenetic response (PCyR).
739546|NCT00101647|O1|Outcome|Participants Achieving MaHR|Percentage of participants achieving MaHR, defined as best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
739547|NCT00101647|O3|Outcome|Total|
739548|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739549|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739550|NCT00101647|O3|Outcome|Total|
739551|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739552|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739553|NCT00101647|O3|Outcome|Total|
739554|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739555|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739556|NCT00101647|O3|Outcome|Total|
739557|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739558|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739559|NCT00101647|O3|Outcome|Total|
739560|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739561|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739562|NCT00101647|O3|Outcome|Total|
739563|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739564|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739565|NCT00101647|O2|Outcome|Total|
739566|NCT00101647|O1|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739567|NCT00101647|O3|Outcome|Total|
739568|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739569|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
739570|NCT00101647|O3|Outcome|Total|
739571|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
739572|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
739573|NCT00101647|E2|Reported Event|Resistant|
739574|NCT00101647|E1|Reported Event|Intolerant|
739575|NCT00101582|B3|Baseline|Total|Total of all reporting groups
739576|NCT00101582|B2|Baseline|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739577|NCT00101582|B1|Baseline|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739578|NCT00101582|P2|Participant Flow|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
739579|NCT00101582|P1|Participant Flow|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
739580|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739581|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739628|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
739586|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739587|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739588|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739589|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739590|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739591|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739592|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739593|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739594|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739595|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739596|NCT00101582|E2|Reported Event|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
739597|NCT00101582|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
739598|NCT00101452|B4|Baseline|Total|Total of all reporting groups
739599|NCT00101452|B3|Baseline|3. Placebo|Sugar Pill- contains no active ingrediants
739600|NCT00101452|B2|Baseline|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
739601|NCT00101452|B1|Baseline|1. SAMe|a naturally occurring substance
739602|NCT00101452|P3|Participant Flow|3. Placebo|Placebo is a non-active treatment, sometimes called a sugar pill.
739603|NCT00101452|P2|Participant Flow|2. Escitalopram|Patients start with 10mg/day for the first 6 weeks. If they do not feel better after 6 weeks, they can increase to 20mg/day.
739604|NCT00101452|P1|Participant Flow|1. SAMe|Patients start with 1600mg/day for the first. If they do not feel better after 6 weeks, they may increase to 3200mg/day if their lab tests are normal.
739605|NCT00101452|O3|Outcome|3. Placebo|Sugar Pill- contains no active ingrediants
739606|NCT00101452|O2|Outcome|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
739607|NCT00101452|O1|Outcome|1. SAMe|a naturally occurring substance
739608|NCT00101452|E7|Reported Event|7. SAMe Plus Escitalopram (Weeks 12-24, Cross-over)|A naturally occurring substance (S-adenosyl methionine) plus a selective serotonin reuptake inhibitor (SSRI)
739609|NCT00101452|E6|Reported Event|6. Placebo (Weeks 12-24, Continuation)|Sugar Pill- contains no active ingredients
739610|NCT00101452|E5|Reported Event|5. Escitalopram (Weeks 12-24, Continuation)|A selective serotonin reuptake inhibitor (SSRI)
739611|NCT00101452|E4|Reported Event|4. SAMe (Weeks 12-24, Continuation)|A naturally occurring substance (S-adenosyl methionine)
739612|NCT00101452|E3|Reported Event|3. Placebo (Weeks 1-12)|Sugar Pill- contains no active ingredients
739613|NCT00101452|E2|Reported Event|2. Escitalopram (Weeks 1-12)|A selective serotonin reuptake inhibitor (SSRI)
739614|NCT00101452|E1|Reported Event|1. SAMe (Weeks 1-12)|A naturally occurring substance (S-adenosyl methionine)
739615|NCT00101439|B3|Baseline|Total|Total of all reporting groups
739616|NCT00101439|B2|Baseline|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
739617|NCT00101439|B1|Baseline|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
739618|NCT00101439|P2|Participant Flow|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
739619|NCT00101439|P1|Participant Flow|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
739620|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
739621|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
739622|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
739623|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
739624|NCT00101439|E2|Reported Event|Placebo|Participants received placebo once daily for 4 weeks
739625|NCT00101439|E1|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe once daily for 4 weeks
739626|NCT00101413|B1|Baseline|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
755835|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
739630|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
739631|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
739632|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
739633|NCT00101413|E1|Reported Event|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
739634|NCT00101400|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739635|NCT00101400|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739636|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739637|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739638|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739639|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739640|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739641|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739642|NCT00101400|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
739643|NCT00101361|B3|Baseline|Total|Total of all reporting groups
739644|NCT00101361|B2|Baseline|Placebo|placebo
739645|NCT00101361|B1|Baseline|Oxandrolone|Oxandrolone
739646|NCT00101361|P2|Participant Flow|2 Placebo|placebo - two capsules twice daily
739647|NCT00101361|P1|Participant Flow|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
739648|NCT00101361|O2|Outcome|2 Placebo|placebo - two capsules twice daily
739649|NCT00101361|O1|Outcome|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
739650|NCT00101361|E2|Reported Event|2 Placebo|placebo - two capsules twice daily
739651|NCT00101361|E1|Reported Event|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
739652|NCT00101283|B3|Baseline|Total|Total of all reporting groups
739653|NCT00101283|B2|Baseline|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
739654|NCT00101283|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
739655|NCT00101283|P2|Participant Flow|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
739656|NCT00101283|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
739657|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
739658|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
739659|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
739660|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
739661|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
739662|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
739663|NCT00101283|E2|Reported Event|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
739664|NCT00101283|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
739665|NCT00101192|B1|Baseline|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
739666|NCT00101192|P1|Participant Flow|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
739667|NCT00101192|O1|Outcome|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
739668|NCT00101192|E1|Reported Event|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
739669|NCT00101166|B1|Baseline|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
739670|NCT00101166|P1|Participant Flow|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
740317|NCT00098345|E1|Reported Event|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
739671|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
739672|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
739673|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
739674|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
739675|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
739676|NCT00101166|E1|Reported Event|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
739677|NCT00101101|B1|Baseline|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
739678|NCT00101101|P1|Participant Flow|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
739679|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
739680|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
739681|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
739717|NCT00100815|P1|Participant Flow|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
739718|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
740318|NCT00098306|B4|Baseline|Total|Total of all reporting groups
739682|NCT00101101|E1|Reported Event|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
739683|NCT00101036|B3|Baseline|Total|Total of all reporting groups
739684|NCT00101036|B2|Baseline|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
739685|NCT00101036|B1|Baseline|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
739686|NCT00101036|P2|Participant Flow|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
739687|NCT00101036|P1|Participant Flow|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
739688|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
739689|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
739690|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
739691|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
739692|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
739693|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
739694|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
739695|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
739696|NCT00101036|E2|Reported Event|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
739697|NCT00101036|E1|Reported Event|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
739698|NCT00100932|B3|Baseline|Total|Total of all reporting groups
739699|NCT00100932|B2|Baseline|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
739700|NCT00100932|B1|Baseline|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
739701|NCT00100932|P2|Participant Flow|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
739702|NCT00100932|P1|Participant Flow|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
739703|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
739704|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
739705|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
739706|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
739707|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
739708|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
739709|NCT00100932|E2|Reported Event|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
739710|NCT00100932|E1|Reported Event|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
739711|NCT00100841|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
739712|NCT00100841|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
739713|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
739714|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
739715|NCT00100841|E1|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
739716|NCT00100815|B1|Baseline|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
739893|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739719|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
739720|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
739721|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
739722|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
739723|NCT00100815|E1|Reported Event|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
739724|NCT00100802|B1|Baseline|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
739725|NCT00100802|P1|Participant Flow|Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
739726|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
739727|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
739728|NCT00100802|E1|Reported Event|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
739729|NCT00100789|B1|Baseline|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
739730|NCT00100789|P1|Participant Flow|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
739731|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
739732|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
739733|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
739734|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
739735|NCT00100789|E1|Reported Event|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
739736|NCT00100698|B3|Baseline|Total|Total of all reporting groups
739737|NCT00100698|B2|Baseline|Placebo|placebo subcutaneously once a day
739738|NCT00100698|B1|Baseline|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739739|NCT00100698|P2|Participant Flow|Placebo|placebo subcutaneously once a day
739740|NCT00100698|P1|Participant Flow|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739741|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739742|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739743|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739744|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739745|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739746|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739747|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739748|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739749|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739750|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739751|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739752|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739753|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739754|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739755|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739756|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739757|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739758|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739759|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739760|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739761|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739762|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739763|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739764|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739765|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739766|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739767|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739768|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739769|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739770|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739771|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739772|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739773|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739774|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739775|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
739776|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739777|NCT00100698|E2|Reported Event|Placebo|placebo subcutaneously once a day
739778|NCT00100698|E1|Reported Event|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
739779|NCT00100659|B3|Baseline|Total|Total of all reporting groups
739780|NCT00100659|B2|Baseline|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
739781|NCT00100659|B1|Baseline|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
739818|NCT00100048|B2|Baseline|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase (10 Days)~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine"
755836|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
739782|NCT00100659|P2|Participant Flow|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
739783|NCT00100659|P1|Participant Flow|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
739784|NCT00100659|O2|Outcome|PEG/Placebo|Pegylated interferon/placebo
739785|NCT00100659|O1|Outcome|PEG/RV|Pegylated interferon/ribavirin
739786|NCT00100659|E2|Reported Event|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
739787|NCT00100659|E1|Reported Event|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
739788|NCT00100230|B3|Baseline|Total|Total of all reporting groups
739789|NCT00100230|B2|Baseline|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
739790|NCT00100230|B1|Baseline|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
739791|NCT00100230|P2|Participant Flow|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
739792|NCT00100230|P1|Participant Flow|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
739793|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil) ARM|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
739794|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid) ARM|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
739795|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
739796|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
739797|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
739798|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
739799|NCT00100230|E2|Reported Event|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
739800|NCT00100230|E1|Reported Event|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
739801|NCT00100178|B4|Baseline|Total|Total of all reporting groups
739802|NCT00100178|B3|Baseline|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
739803|NCT00100178|B2|Baseline|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND saline intravenous infusions given at baseline and two weeks later
739804|NCT00100178|B1|Baseline|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later.
739805|NCT00100178|P3|Participant Flow|MMF-DZB Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
739806|NCT00100178|P2|Participant Flow|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
739807|NCT00100178|P1|Participant Flow|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
739808|NCT00100178|O3|Outcome|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
739809|NCT00100178|O2|Outcome|Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
739810|NCT00100178|O1|Outcome|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
739811|NCT00100178|E3|Reported Event|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
739812|NCT00100178|E2|Reported Event|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
739813|NCT00100178|E1|Reported Event|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later .
739814|NCT00100048|B6|Baseline|Total|Total of all reporting groups
739815|NCT00100048|B5|Baseline|Placebo / Efavirenz 600 mg Once Daily (q.d.)|"Cohort I-Monotherapy Phase (10 Days)~Placebo to MK0518 b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks)~Efavirenz + Tenofovir + Lamivudine"
739816|NCT00100048|B4|Baseline|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine"
739817|NCT00100048|B3|Baseline|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine"
739819|NCT00100048|B1|Baseline|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d"
739820|NCT00100048|P6|Participant Flow|Efavirenz 600 mg q.h.s.|"Cohort II Combined-Combination Therapy Phase~efavirenz 600 mg every night at bedtime (q.h.s.)"
739821|NCT00100048|P5|Participant Flow|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
739822|NCT00100048|P4|Participant Flow|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739823|NCT00100048|P3|Participant Flow|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739824|NCT00100048|P2|Participant Flow|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739825|NCT00100048|P1|Participant Flow|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739826|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739827|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739828|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739829|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739830|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739831|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739832|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739833|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739834|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739835|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739836|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739837|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739838|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739839|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739840|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739841|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739842|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739843|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
739844|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739845|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739846|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739847|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739848|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
739849|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739850|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739851|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739852|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739853|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739854|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739855|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739856|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739857|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
739858|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739859|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739860|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739861|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739862|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739863|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739864|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739865|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739866|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739867|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739868|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739869|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739870|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739871|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739872|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739873|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739874|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739875|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739876|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739877|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739878|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739879|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739880|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739881|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739882|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739883|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739884|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739885|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739886|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739887|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739888|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739889|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739890|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739891|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739892|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739894|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739895|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739896|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739897|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739898|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739899|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739900|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739901|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739902|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739903|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739904|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739905|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739906|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739907|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739908|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739909|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739910|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739911|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739912|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739913|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739914|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
739915|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
739916|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
739917|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
739918|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
739919|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
739920|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d."
739921|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d."
739922|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
739923|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)"
739924|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
739925|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d."
739926|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d."
739927|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
739928|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)"
739929|NCT00100048|E2|Reported Event|Efavirenz|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
739930|NCT00100048|E1|Reported Event|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
739931|NCT00099983|B3|Baseline|Total|Total of all reporting groups
739932|NCT00099983|B2|Baseline|Sugar Pill|"PTSD~Placebo : Placebo"
739933|NCT00099983|B1|Baseline|Risperidone|Risperidone : atypical antipsychotic
739934|NCT00099983|P2|Participant Flow|Sugar Pill|Placebo Sugar Pill 1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day).
739974|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
739975|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
755837|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
739935|NCT00099983|P1|Participant Flow|Risperidone|"an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette’s disorder, pervasive developmental disorder and autism.~(1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day)."
739936|NCT00099983|O2|Outcome|Sugar Pill|"Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Placebo: Placebo"
739937|NCT00099983|O1|Outcome|Risperidone|"1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Risperidone: Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time."
739938|NCT00099983|E2|Reported Event|Sugar Pill|"PTSD~Placebo : Placebo"
739939|NCT00099983|E1|Reported Event|Risperidone|Risperidone : atypical antipsychotic
739940|NCT00099632|B7|Baseline|Total|Total of all reporting groups
739941|NCT00099632|B6|Baseline|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739942|NCT00099632|B5|Baseline|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
739943|NCT00099632|B4|Baseline|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
739944|NCT00099632|B3|Baseline|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
739945|NCT00099632|B2|Baseline|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
739946|NCT00099632|B1|Baseline|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
739947|NCT00099632|P6|Participant Flow|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739948|NCT00099632|P5|Participant Flow|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
739949|NCT00099632|P4|Participant Flow|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
739950|NCT00099632|P3|Participant Flow|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
739951|NCT00099632|P2|Participant Flow|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
739952|NCT00099632|P1|Participant Flow|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
739953|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739954|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
739955|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
739956|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
739957|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
739958|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
739959|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739960|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
739961|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
739962|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
739963|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
739964|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
739965|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739966|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
739967|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
739968|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
739969|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
739970|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
739971|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739972|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
739973|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
755838|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
739976|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
739977|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739978|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
739979|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
739980|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
739981|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
739982|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
739983|NCT00099632|E6|Reported Event|21-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r
739984|NCT00099632|E5|Reported Event|7-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
739985|NCT00099632|E4|Reported Event|21-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF
739986|NCT00099632|E3|Reported Event|7-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF
739987|NCT00099632|E2|Reported Event|21-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV
739988|NCT00099632|E1|Reported Event|7-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV
739989|NCT00099437|B3|Baseline|Total|Total of all reporting groups
739990|NCT00099437|B2|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
739991|NCT00099437|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
739992|NCT00099437|P2|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
739993|NCT00099437|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
739994|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
739995|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
739996|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
739997|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
739998|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
739999|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
740000|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
740001|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
740002|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
740003|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
740004|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
740005|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
740006|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
740007|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
740008|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
740009|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
740010|NCT00099437|E2|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
740011|NCT00099437|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
740012|NCT00099359|B4|Baseline|Total|Total of all reporting groups
740013|NCT00099359|B3|Baseline|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
740014|NCT00099359|B2|Baseline|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
740015|NCT00099359|B1|Baseline|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
740016|NCT00099359|P3|Participant Flow|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
740017|NCT00099359|P2|Participant Flow|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
740018|NCT00099359|P1|Participant Flow|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
740019|NCT00099359|O1|Outcome|ARM B (ZDV + NVP)|NVP concentrations were measured in 14 infants immediately before the 3rd dose, 4 hours post dose, 1 day post dose, 3-5 days post dose and 7 days post dose.
740020|NCT00099359|O2|Outcome|Uninfected|Infants uninfected after birth
740021|NCT00099359|O1|Outcome|Infected|Infants infected after birth
740570|NCT00097773|B2|Baseline|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
740022|NCT00099359|O1|Outcome|ARM C (ZDV + 3TC/NFV)|Standard ZDV for 6 weeks combined with 2 weeks of 3TC and NFV. NFV and 3TC plasma concentrations were measured by validated HPLC assays with lower detection limit of 0.04 micrograms/mL.
740023|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
740024|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
740025|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
740026|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
740027|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
740028|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
740029|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC/NFV)|ZDV + 3TC/NFV
740030|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|ZDV + NVP
740031|NCT00099359|O1|Outcome|ARM A (ZDV Only)|ZDV only
740032|NCT00099359|O3|Outcome|ARM C (ZDV +3TC+NFV)|"ZDV (standard of care) plus 3TC, given for 2 weeks:~6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
740033|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams
740034|NCT00099359|O1|Outcome|ARM A (ZDV - Standard of Care)|"ZDV (standard of care), given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
740035|NCT00099359|E3|Reported Event|ARM C (ZDV + 3TC/NFV)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
740036|NCT00099359|E2|Reported Event|ARM B (ZDV + NVP)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams~AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
740037|NCT00099359|E1|Reported Event|ARM A (ZDV Alone)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
740038|NCT00099268|B3|Baseline|Total|Total of all reporting groups
740039|NCT00099268|B2|Baseline|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740040|NCT00099268|B1|Baseline|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740041|NCT00099268|P2|Participant Flow|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740042|NCT00099268|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740043|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740044|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740045|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740046|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740047|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740571|NCT00097773|B1|Baseline|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
740048|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740049|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740050|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740051|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740052|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740053|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740054|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740055|NCT00099268|E2|Reported Event|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740056|NCT00099268|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
740057|NCT00099047|B3|Baseline|Total|Total of all reporting groups
740058|NCT00099047|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740059|NCT00099047|B1|Baseline|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740060|NCT00099047|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740061|NCT00099047|P1|Participant Flow|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740062|NCT00099047|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740063|NCT00099047|O1|Outcome|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740064|NCT00099047|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740065|NCT00099047|E1|Reported Event|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
740066|NCT00099021|B1|Baseline|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
740067|NCT00099021|P1|Participant Flow|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
740068|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
740069|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
740070|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
740071|NCT00099021|E1|Reported Event|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
740072|NCT00098956|B1|Baseline|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
740073|NCT00098956|P1|Participant Flow|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
740074|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
740851|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
740075|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
740076|NCT00098956|E1|Reported Event|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
740077|NCT00098865|B1|Baseline|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
740078|NCT00098865|P1|Participant Flow|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression"
740079|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
740080|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
740081|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
740082|NCT00098865|E1|Reported Event|Thalidomide and Temzolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
740083|NCT00098839|B3|Baseline|Total|Total of all reporting groups
740084|NCT00098839|B2|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740085|NCT00098839|B1|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740086|NCT00098839|P2|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740087|NCT00098839|P1|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740088|NCT00098839|O1|Outcome|Twice Weekly Dosing Schedule|Epratuzumab 360 mg/m2 x 8 doses – Part B (Amendment 5)
740089|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740090|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740091|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740092|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740093|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740111|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
740112|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740094|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740095|NCT00098839|E2|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740096|NCT00098839|E1|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
740097|NCT00098813|B1|Baseline|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
740098|NCT00098813|P1|Participant Flow|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
740099|NCT00098813|O1|Outcome|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
740100|NCT00098813|E1|Reported Event|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
740101|NCT00098787|B4|Baseline|Total|Total of all reporting groups
740102|NCT00098787|B3|Baseline|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
740103|NCT00098787|B2|Baseline|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740104|NCT00098787|B1|Baseline|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740105|NCT00098787|P3|Participant Flow|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
740106|NCT00098787|P2|Participant Flow|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740107|NCT00098787|P1|Participant Flow|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740108|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
740109|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740110|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740155|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740113|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740114|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
740115|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740116|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740117|NCT00098787|E3|Reported Event|Low or Indeterminate TS: FOLFOX/Bev|Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
740118|NCT00098787|E2|Reported Event|High TS: FOLFOX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
740119|NCT00098787|E1|Reported Event|High TS: IROX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol.
740120|NCT00098774|B1|Baseline|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
740121|NCT00098774|P1|Participant Flow|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
740122|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
740123|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
740124|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
740125|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
740154|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740126|NCT00098774|E1|Reported Event|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
740127|NCT00098748|B4|Baseline|Total|Total of all reporting groups
740128|NCT00098748|B3|Baseline|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740129|NCT00098748|B2|Baseline|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740130|NCT00098748|B1|Baseline|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740131|NCT00098748|P3|Participant Flow|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740132|NCT00098748|P2|Participant Flow|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740133|NCT00098748|P1|Participant Flow|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740134|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740135|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740136|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740137|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740138|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740139|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740140|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740141|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740142|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740143|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740144|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740145|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740146|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740147|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740148|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740149|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740150|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740151|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740152|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740153|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740308|NCT00098345|B1|Baseline|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740156|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740157|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740158|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740159|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740160|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740161|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740162|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740163|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740164|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740165|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740166|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740167|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740168|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740169|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740170|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740171|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740172|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740173|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740174|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740175|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740176|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740177|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740178|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740179|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740180|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740181|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740182|NCT00098748|E3|Reported Event|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
740183|NCT00098748|E2|Reported Event|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
740184|NCT00098748|E1|Reported Event|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
740185|NCT00098722|B4|Baseline|Total|Total of all reporting groups
740186|NCT00098722|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740187|NCT00098722|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740188|NCT00098722|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740189|NCT00098722|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740190|NCT00098722|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740191|NCT00098722|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
740192|NCT00098722|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
740193|NCT00098722|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740194|NCT00098722|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740195|NCT00098722|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740196|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740197|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740198|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740199|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740200|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740201|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740202|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740203|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740204|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740205|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740309|NCT00098345|P1|Participant Flow|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
755839|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
740206|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740207|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740208|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740209|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740210|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740211|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740212|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740213|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740214|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740215|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740216|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740217|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740218|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740219|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740220|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740221|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740222|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740223|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740224|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740225|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740226|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740227|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740228|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740229|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740230|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740231|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740232|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740233|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740234|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740235|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740236|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740237|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740238|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740239|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740240|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740241|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740242|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740243|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740244|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740245|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740246|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740247|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740248|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740249|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740250|NCT00098722|E7|Reported Event|In Study-off Drug, Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740251|NCT00098722|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740252|NCT00098722|E5|Reported Event|In Study-off Drug, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
740253|NCT00098722|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
740254|NCT00098722|E3|Reported Event|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740255|NCT00098722|E2|Reported Event|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740256|NCT00098722|E1|Reported Event|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740257|NCT00098670|B1|Baseline|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
740258|NCT00098670|P1|Participant Flow|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
740259|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
740260|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
740261|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
740262|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
740263|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
740264|NCT00098670|E2|Reported Event|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction
740265|NCT00098670|E1|Reported Event|FR Induction|Fludarabine and rituximab induction in pts with B-cell CLL
740266|NCT00098475|B3|Baseline|Total|Total of all reporting groups
740267|NCT00098475|B2|Baseline|Arm II (Lenalidomide, Low-dose Dexamethasone)|"Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
740268|NCT00098475|B1|Baseline|Arm I (Lenalidomide, Dexamethasone)|"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
740269|NCT00098475|P4|Participant Flow|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
740310|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740311|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740312|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740270|NCT00098475|P3|Participant Flow|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
740271|NCT00098475|P2|Participant Flow|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
740272|NCT00098475|P1|Participant Flow|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
740273|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
740274|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
740275|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
740276|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
740277|NCT00098475|E6|Reported Event|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
740278|NCT00098475|E5|Reported Event|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
740279|NCT00098475|E4|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2|Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
740280|NCT00098475|E3|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 2|Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
740281|NCT00098475|E2|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
740282|NCT00098475|E1|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 1|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
740283|NCT00098371|B1|Baseline|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740313|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740314|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740315|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740316|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
740284|NCT00098371|P1|Participant Flow|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.To improve tolerability of treatment regimen, an amendment to the protocol was done to reduce the cycle length from 42 days to 28 days, reducing the number of treatments per cycle from four (days 1, 8, 15 & 22) to three (days 1, 8, and 15).
740285|NCT00098371|O2|Outcome|Non-Responders|Patients who had stable disease (SD) or progressive disease (PD)
740286|NCT00098371|O1|Outcome|Responders|Patients who achieved a partial response (PR)
740287|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740288|NCT00098371|O6|Outcome|Patients Without Complex Karyotype|Complex Karyotype defined as fewer than three cytogenetic aberrations.
740289|NCT00098371|O5|Outcome|Patients With Complex Karyotype|Complex Karyotype defined as three or more cytogenetic aberrations.
740290|NCT00098371|O4|Outcome|Patients Without Del(11q22.3)|
740291|NCT00098371|O3|Outcome|Patients With Del(11q22.3)|
740292|NCT00098371|O2|Outcome|Patients Without Del(17p13.1)|
740293|NCT00098371|O1|Outcome|Patients With Del(17p13.1)|
740294|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.~alvocidib"
740295|NCT00098371|O2|Outcome|Group 2|Patients with dexamethasone
740296|NCT00098371|O1|Outcome|Group 1|Patients without dexamethasone
740297|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740298|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740299|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740300|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.~alvocidib"
740301|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740302|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740303|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740304|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740305|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740306|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
740307|NCT00098371|E1|Reported Event|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
756537|NCT00029146|B3|Baseline|Total|Total of all reporting groups
740319|NCT00098306|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740320|NCT00098306|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740321|NCT00098306|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740322|NCT00098306|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740323|NCT00098306|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740324|NCT00098306|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
740325|NCT00098306|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
740326|NCT00098306|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740327|NCT00098306|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740328|NCT00098306|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740329|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740330|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740331|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740332|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740333|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740334|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740335|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740336|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740337|NCT00098306|O1|Outcome|Maraviroc QD|Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740338|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740568|NCT00097773|B4|Baseline|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
740339|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740340|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740341|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740342|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740343|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740344|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740345|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740346|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740347|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740348|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740349|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740350|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740351|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740352|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740353|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740354|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740355|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740356|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740357|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740358|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740359|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740360|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740361|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740362|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740363|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740364|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740365|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740366|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740367|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740368|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740369|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740370|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740371|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740372|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740373|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740374|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740375|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740376|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740377|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740378|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740379|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740380|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740381|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740382|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740383|NCT00098306|E7|Reported Event|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740384|NCT00098306|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
740385|NCT00098306|E5|Reported Event|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
740386|NCT00098306|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
740387|NCT00098306|E3|Reported Event|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740388|NCT00098306|E2|Reported Event|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
740389|NCT00098306|E1|Reported Event|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
740390|NCT00098293|B4|Baseline|Total|Total of all reporting groups
740391|NCT00098293|B3|Baseline|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.
740392|NCT00098293|B2|Baseline|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
740393|NCT00098293|B1|Baseline|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
740394|NCT00098293|P5|Participant Flow|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
740395|NCT00098293|P4|Participant Flow|Maraviroc Twice Daily + CBV (OL)|Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.
740396|NCT00098293|P3|Participant Flow|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
741738|NCT00095238|O1|Outcome|Placebo - Month 6|Placebo cohort with measurements at baseline and Month 6.
740397|NCT00098293|P2|Participant Flow|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
740398|NCT00098293|P1|Participant Flow|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
740399|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740400|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740401|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740402|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740403|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740404|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740405|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740406|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740407|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740408|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740409|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740410|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740411|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740412|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740464|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740852|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
740413|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740414|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740415|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740416|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740417|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740418|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740419|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740420|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740421|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740422|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740423|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740424|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740425|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740426|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740427|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740428|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
757153|NCT00021541|O1|Outcome|Phase A - Tipifarnib|Tipifarnib
740429|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740430|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740431|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740432|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740433|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740434|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740435|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740436|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740437|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740438|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740439|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740440|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740441|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740442|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740443|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
740444|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
757154|NCT00021541|O1|Outcome|Phase A - Tipifarnib|Tipifarnib
740445|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740446|NCT00098293|E4|Reported Event|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
740447|NCT00098293|E3|Reported Event|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
740448|NCT00098293|E2|Reported Event|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
740449|NCT00098293|E1|Reported Event|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
740450|NCT00098254|B1|Baseline|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740451|NCT00098254|P1|Participant Flow|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740452|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740453|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740454|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740455|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740456|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740457|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740458|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740459|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740460|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740461|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740462|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740463|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740569|NCT00097773|B3|Baseline|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
740465|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740466|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740467|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740468|NCT00098254|E1|Reported Event|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
740469|NCT00098059|B3|Baseline|Total|Total of all reporting groups
740470|NCT00098059|B2|Baseline|Part B (Multiple-dose of Famciclovir)|Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose.
740471|NCT00098059|B1|Baseline|Part A (Single-dose of Famciclovir)|Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
740472|NCT00098059|P2|Participant Flow|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
740473|NCT00098059|P1|Participant Flow|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
740474|NCT00098059|O4|Outcome|13 to <=18 Years|
740475|NCT00098059|O3|Outcome|6 to <13 Years|
740476|NCT00098059|O2|Outcome|2 to <6 Years|
740477|NCT00098059|O1|Outcome|1 to < 2 Years|
740478|NCT00098059|O4|Outcome|13 to <= 18 Years|
740479|NCT00098059|O3|Outcome|6 to <=12 Years|
740480|NCT00098059|O2|Outcome|2 to <6 Years|
740481|NCT00098059|O1|Outcome|1 to < 2 Years|
740482|NCT00098059|O4|Outcome|13 to <= 18 Years|
740483|NCT00098059|O3|Outcome|6 to <=12 Years|
740484|NCT00098059|O2|Outcome|2 to <6 Years|
740485|NCT00098059|O1|Outcome|1 to < 2 Years|
740486|NCT00098059|O4|Outcome|13 to <= 18 Years|
740487|NCT00098059|O3|Outcome|6 to <=12 Years|
740488|NCT00098059|O2|Outcome|2 to <6 Years|
740489|NCT00098059|O1|Outcome|1 to < 2 Years|
740490|NCT00098059|O4|Outcome|13 to < =18 Years|
740491|NCT00098059|O3|Outcome|6 to <=12 Years|
740492|NCT00098059|O2|Outcome|2 to <6 Years|
740493|NCT00098059|O1|Outcome|1 to < 2 Years|
740494|NCT00098059|O4|Outcome|13 to <= 18 Years|
740495|NCT00098059|O3|Outcome|6 to <=12 Years|
740496|NCT00098059|O2|Outcome|2 to <6 Years|
740497|NCT00098059|O1|Outcome|1 to < 2 Years|
740498|NCT00098059|O4|Outcome|13 to <= 18 Years|
740499|NCT00098059|O3|Outcome|6 to <=12 Years|
740500|NCT00098059|O2|Outcome|2 to <6 Years|
740501|NCT00098059|O1|Outcome|1 to < 2 Years|
740502|NCT00098059|O4|Outcome|13 to <=18 Years|
740503|NCT00098059|O3|Outcome|6 to <13 Years|
740504|NCT00098059|O2|Outcome|2 to <6 Years|
740505|NCT00098059|O1|Outcome|1 to < 2 Years|
740506|NCT00098059|O4|Outcome|13 to <=18 Years|
740507|NCT00098059|O3|Outcome|6 to <13 Years|
740508|NCT00098059|O2|Outcome|2 to <6 Years|
740509|NCT00098059|O1|Outcome|1 to < 2 Years|
740510|NCT00098059|O4|Outcome|13 to <=18 Years|
740511|NCT00098059|O3|Outcome|6 to <13 Years|
740512|NCT00098059|O2|Outcome|2 to <6 Years|
740513|NCT00098059|O1|Outcome|1 to < 2 Years|
740514|NCT00098059|E2|Reported Event|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
740515|NCT00098059|E1|Reported Event|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
740516|NCT00098020|B1|Baseline|Isotretinoin|subjects will be treated with iIsotretinoin.
740517|NCT00098020|P1|Participant Flow|Isotretinoin|"Subjects will be treated with isotretinoin initially at 1mg/kg for the first 4 weeks and then dose will escalate to a higher dose only if subjects have tolerated the lower dose.~In younger patients of 16 and 17 years of age, the dose will be started at 1 mg/kg and will remain at this dose without escalation."
740518|NCT00098020|O1|Outcome|Isotretinoin|oral isotretinoin
740519|NCT00098020|O1|Outcome|Isotretinoin|oral isotretinoin
740520|NCT00098020|E1|Reported Event|Isotretinoin|Subjects will be treated with isotretinoin .
740521|NCT00097981|B3|Baseline|Total|Total of all reporting groups
740522|NCT00097981|B2|Baseline|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740566|NCT00097786|E1|Reported Event|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
740523|NCT00097981|B1|Baseline|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740524|NCT00097981|P2|Participant Flow|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740525|NCT00097981|P1|Participant Flow|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740526|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740527|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740528|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740529|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740530|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740531|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740532|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740533|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740534|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740535|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740536|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740537|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740538|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740539|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740540|NCT00097981|E2|Reported Event|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740541|NCT00097981|E1|Reported Event|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
740542|NCT00097786|B5|Baseline|Total|Total of all reporting groups
740543|NCT00097786|B4|Baseline|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
740544|NCT00097786|B3|Baseline|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
740545|NCT00097786|B2|Baseline|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
740546|NCT00097786|B1|Baseline|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
740547|NCT00097786|P4|Participant Flow|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
740548|NCT00097786|P3|Participant Flow|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
740549|NCT00097786|P2|Participant Flow|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
740550|NCT00097786|P1|Participant Flow|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
740551|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
740552|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
740553|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
740554|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
740555|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
740556|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
740557|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
740558|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
740559|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
740560|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
740561|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
740562|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
740563|NCT00097786|E4|Reported Event|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
740564|NCT00097786|E3|Reported Event|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
740565|NCT00097786|E2|Reported Event|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
740567|NCT00097773|B5|Baseline|Total|Total of all reporting groups
740572|NCT00097773|P4|Participant Flow|Culture-Based TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
740573|NCT00097773|P3|Participant Flow|Culture-Based TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
740574|NCT00097773|P2|Participant Flow|Cycled TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
740575|NCT00097773|P1|Participant Flow|Cycled TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
740576|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
740577|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
740578|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
740579|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS therapy group
740580|NCT00097773|O4|Outcome|Oral Placebo|pooled oral placebo group
740581|NCT00097773|O3|Outcome|Oral Cipro|Pooled oral cipro group
740582|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS group
740583|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS group
740584|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
740585|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
740586|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
740587|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
740588|NCT00097773|E4|Reported Event|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
740589|NCT00097773|E3|Reported Event|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
740590|NCT00097773|E2|Reported Event|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
740591|NCT00097773|E1|Reported Event|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
740592|NCT00097721|B3|Baseline|Total|Total of all reporting groups
740593|NCT00097721|B2|Baseline|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740594|NCT00097721|B1|Baseline|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740595|NCT00097721|P2|Participant Flow|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740596|NCT00097721|P1|Participant Flow|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740597|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740598|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740599|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740600|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740601|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740602|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740603|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740604|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740605|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740606|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740607|NCT00097721|E2|Reported Event|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
740608|NCT00097721|E1|Reported Event|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
740609|NCT00097708|B4|Baseline|Total|Total of all reporting groups
740610|NCT00097708|B3|Baseline|Placebo|
740611|NCT00097708|B2|Baseline|IR Alprazolam|
740612|NCT00097708|B1|Baseline|OROS Alprazolam|
740613|NCT00097708|P3|Participant Flow|Placebo|OROS (osmotic [controlled] release oral [delivery] system) placebo administered orally once a day.
740614|NCT00097708|P2|Participant Flow|IR Alprazolam|IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
740615|NCT00097708|P1|Participant Flow|OROS Alprazolam|OROS (osmotic [controlled] release oral [delivery] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
740616|NCT00097708|O3|Outcome|Placebo|
740617|NCT00097708|O2|Outcome|IR Alprazolam|
740618|NCT00097708|O1|Outcome|OROS Alprazolam|
740619|NCT00097708|E3|Reported Event|Placebo|
740620|NCT00097708|E2|Reported Event|IR Alprazolam|
740621|NCT00097708|E1|Reported Event|OROS Alprazolam|
740622|NCT00097695|B5|Baseline|Total|Total of all reporting groups
740623|NCT00097695|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
740624|NCT00097695|B3|Baseline|Controlled Open-label / Laryngeal Attack|patients who received first treatment Open-Label due to laryngeal symptoms
740625|NCT00097695|B2|Baseline|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
740626|NCT00097695|B1|Baseline|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
740853|NCT00096681|E1|Reported Event|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
740627|NCT00097695|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
740628|NCT00097695|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
740629|NCT00097695|P2|Participant Flow|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
740630|NCT00097695|P1|Participant Flow|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
740631|NCT00097695|O2|Outcome|Randomized Control Trial-placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
740632|NCT00097695|O1|Outcome|Randomized Control Trial-icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
740633|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
740634|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
740635|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
740636|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
740637|NCT00097695|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline)|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
740638|NCT00097695|E5|Reported Event|Open Label Extension -Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase.
740639|NCT00097695|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant or placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
740640|NCT00097695|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
740641|NCT00097695|E2|Reported Event|Controlled Phase- Placebo (Randomized Subjects|Patients who were randomized to placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
740642|NCT00097695|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant in the controlled and experienced adverse events while participating in the controlled phase.
740643|NCT00097591|B3|Baseline|Total|Total of all reporting groups
740644|NCT00097591|B2|Baseline|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740645|NCT00097591|B1|Baseline|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740646|NCT00097591|P2|Participant Flow|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740647|NCT00097591|P1|Participant Flow|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740648|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740649|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740650|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740651|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740652|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740653|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740654|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740655|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740656|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
742883|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
740657|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740658|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740659|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740660|NCT00097591|E2|Reported Event|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
740661|NCT00097591|E1|Reported Event|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
740662|NCT00097539|B8|Baseline|Total|Total of all reporting groups
740663|NCT00097539|B7|Baseline|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740664|NCT00097539|B6|Baseline|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740665|NCT00097539|B5|Baseline|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740666|NCT00097539|B4|Baseline|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740667|NCT00097539|B3|Baseline|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740668|NCT00097539|B2|Baseline|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740669|NCT00097539|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
740670|NCT00097539|P7|Participant Flow|Undefined Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740671|NCT00097539|P6|Participant Flow|Other Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. The other etiology group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740672|NCT00097539|P5|Participant Flow|Renal Disease|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Renal etiology group included participants with chronic renal insufficiency (CRI) or End Stage Renal Disease (ESRD) prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740673|NCT00097539|P4|Participant Flow|Turner Syndrome|Participants with Turner Syndrome who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740674|NCT00097539|P3|Participant Flow|Idiopathic Short Stature (ISS)|Participants with ISS who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants must have had a stimulation result of greater than or equal to (>/=) 10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740693|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740694|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740675|NCT00097539|P2|Participant Flow|Organic Growth Hormone Deficiency (GHD)|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Organic GHD etiology group included participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, central nervous system (CNS) tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740676|NCT00097539|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD)|Participants with IGDH who initiated therapy with Growth Hormone (GH) products (somatrem for injection [Protropin], somatropin for injection [Nutropin, Nutropin AQ, and Nutropin Depot]) and who consented to participate in the National Cooperative Growth Study (NCGS) were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. IGDH etiology group included participants with: Documented IGHD (a maximum GH stimulation test result of less than 10 nanograms per milliliter [ng/mL], coupled with a specific diagnosis of IGHD or equivalent condition by the attending physician; Undocumented IGHD (a stimulation test results were not available, but had a physician diagnosis specifically stated as IGHD or equivalent condition in text); or Presumed IGHD (a stimulation result of less than 10 ng/mL, coupled with the absence of any identifiable criterion for assignation to another etiology grouping).
740677|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740678|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740679|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740680|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740681|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740682|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740683|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
740684|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740685|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740686|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740687|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740688|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740689|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740690|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
740691|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740692|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740751|NCT00097448|E2|Reported Event|IT Steroids|methylprednisolone
740695|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740696|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740697|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
740698|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740699|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740700|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740701|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740702|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740703|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740704|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
740705|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740706|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740707|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740708|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740709|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740710|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740711|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
740712|NCT00097539|E7|Reported Event|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
740713|NCT00097539|E6|Reported Event|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
740714|NCT00097539|E5|Reported Event|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
740715|NCT00097539|E4|Reported Event|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
740752|NCT00097448|E1|Reported Event|Oral Steroids|Prednisone
740716|NCT00097539|E3|Reported Event|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
740717|NCT00097539|E2|Reported Event|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
740718|NCT00097539|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
740719|NCT00097500|B3|Baseline|Total|Total of all reporting groups
740720|NCT00097500|B2|Baseline|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740721|NCT00097500|B1|Baseline|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740722|NCT00097500|P2|Participant Flow|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740723|NCT00097500|P1|Participant Flow|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740724|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740725|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740726|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740727|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740728|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740729|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740730|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740731|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740732|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740733|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740734|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740735|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740736|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740737|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740738|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740739|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740740|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740741|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740742|NCT00097500|E2|Reported Event|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
740743|NCT00097500|E1|Reported Event|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
740744|NCT00097448|B3|Baseline|Total|Total of all reporting groups
740745|NCT00097448|B2|Baseline|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
740746|NCT00097448|B1|Baseline|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
740747|NCT00097448|P2|Participant Flow|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
740748|NCT00097448|P1|Participant Flow|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
740749|NCT00097448|O2|Outcome|IT Steroids|methylprednisolone
740750|NCT00097448|O1|Outcome|Oral Steroids|Prednisone
740753|NCT00097370|B1|Baseline|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740754|NCT00097370|P1|Participant Flow|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by intravenous (IV) infusion monthly in Stage 1 along with concomitant hypereosinophilic syndrome (HES)-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740755|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740756|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740757|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740758|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740759|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740760|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740761|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740762|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740763|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740764|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740765|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740766|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740767|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
742884|NCT00092677|O2|Outcome|Placebo|
740768|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740769|NCT00097370|E1|Reported Event|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
740770|NCT00097253|B1|Baseline|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740771|NCT00097253|P1|Participant Flow|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740772|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740773|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740774|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740775|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740776|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740777|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740778|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740779|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740780|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740781|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740782|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740783|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740784|NCT00097253|E1|Reported Event|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
740785|NCT00096993|B3|Baseline|Total|Total of all reporting groups
740786|NCT00096993|B2|Baseline|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740787|NCT00096993|B1|Baseline|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740788|NCT00096993|P2|Participant Flow|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740789|NCT00096993|P1|Participant Flow|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740790|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740791|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740792|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740793|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740794|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740795|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740796|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740797|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740798|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740799|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740800|NCT00096993|E2|Reported Event|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
740801|NCT00096993|E1|Reported Event|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
740802|NCT00096954|B3|Baseline|Total|Total of all reporting groups
740803|NCT00096954|B2|Baseline|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
740804|NCT00096954|B1|Baseline|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
740805|NCT00096954|P2|Participant Flow|Placebo|The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
740850|NCT00096681|P1|Participant Flow|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
742885|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
740806|NCT00096954|P1|Participant Flow|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
740807|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
740808|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
740809|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
740810|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
740811|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
740812|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
740813|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
740814|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
740815|NCT00096954|E2|Reported Event|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
740816|NCT00096954|E1|Reported Event|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
740817|NCT00096941|B1|Baseline|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
740818|NCT00096941|P1|Participant Flow|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
740819|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
740820|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
740821|NCT00096941|E1|Reported Event|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
740822|NCT00096785|B3|Baseline|Total|Total of all reporting groups
740823|NCT00096785|B2|Baseline|Adefovir|ADV 10 mg QD
740824|NCT00096785|B1|Baseline|Entecavir|ETV 0.5 mg once daily (QD)
740825|NCT00096785|P2|Participant Flow|Adefovir|ADV 10 mg QD
740826|NCT00096785|P1|Participant Flow|Entecavir|ETV 0.5 mg once daily (QD)
740827|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740828|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740829|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740830|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740831|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740832|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740833|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740834|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740835|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740836|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740837|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740838|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740839|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740840|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740841|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740842|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740843|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740844|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740845|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
740846|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
740847|NCT00096785|E2|Reported Event|ETV 0.5 mg|
740848|NCT00096785|E1|Reported Event|ADV 10 mg|
740849|NCT00096681|B1|Baseline|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
740854|NCT00096538|B1|Baseline|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
740855|NCT00096538|P1|Participant Flow|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
740856|NCT00096538|O1|Outcome|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
740857|NCT00096538|E1|Reported Event|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
740858|NCT00096486|B5|Baseline|Total|Total of all reporting groups
740859|NCT00096486|B4|Baseline|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
740860|NCT00096486|B3|Baseline|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
740861|NCT00096486|B2|Baseline|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
740862|NCT00096486|B1|Baseline|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
740863|NCT00096486|P4|Participant Flow|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
740864|NCT00096486|P3|Participant Flow|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
740865|NCT00096486|P2|Participant Flow|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
740866|NCT00096486|P1|Participant Flow|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
740867|NCT00096486|O4|Outcome|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
740868|NCT00096486|O3|Outcome|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
740869|NCT00096486|O2|Outcome|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
740870|NCT00096486|O1|Outcome|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
740871|NCT00096486|E4|Reported Event|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
740872|NCT00096486|E3|Reported Event|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
740873|NCT00096486|E2|Reported Event|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
740874|NCT00096486|E1|Reported Event|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
740875|NCT00096460|B3|Baseline|Total|Total of all reporting groups
740876|NCT00096460|B2|Baseline|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
740877|NCT00096460|B1|Baseline|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
740878|NCT00096460|P2|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
740879|NCT00096460|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
740880|NCT00096460|O2|Outcome|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
740881|NCT00096460|O1|Outcome|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
740882|NCT00096460|E2|Reported Event|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
740883|NCT00096460|E1|Reported Event|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
740884|NCT00096447|B1|Baseline|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740885|NCT00096447|P1|Participant Flow|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740886|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740887|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740888|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740889|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740890|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740891|NCT00096447|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
740892|NCT00096447|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
740893|NCT00096447|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
740894|NCT00096447|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
740895|NCT00096447|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
740896|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740897|NCT00096447|E1|Reported Event|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
740898|NCT00096382|B3|Baseline|Total|Total of all reporting groups
740899|NCT00096382|B2|Baseline|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740900|NCT00096382|B1|Baseline|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740901|NCT00096382|P2|Participant Flow|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740902|NCT00096382|P1|Participant Flow|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740903|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740904|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740905|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740906|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740907|NCT00096382|E2|Reported Event|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740908|NCT00096382|E1|Reported Event|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
740909|NCT00096356|B3|Baseline|Total|Total of all reporting groups
740910|NCT00096356|B2|Baseline|Arm 2 - Placebo & Vitamin E|Placebo plus Vitamin E 100mg/day in 3 doses
740911|NCT00096356|B1|Baseline|Arm 1 - CoQ10 & Vitamin E|CoQ10 plus Vitamin E 100mg/day in 3 doses
740912|NCT00096356|P2|Participant Flow|Arm 2 - Placebo + Vitamin E|Placebo + Vitamin E 100mg/day in 3 doses
740913|NCT00096356|P1|Participant Flow|Arm 1 - CoQ10 + Vitamin E|CoQ10 + Vitamin E 100mg/day in 3 doses
740914|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
740915|NCT00096356|O1|Outcome|Arm 1- CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
740916|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
740917|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
740918|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
740919|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
740920|NCT00096356|E2|Reported Event|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
740921|NCT00096356|E1|Reported Event|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
740922|NCT00096278|B3|Baseline|Total|Total of all reporting groups
740923|NCT00096278|B2|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
740924|NCT00096278|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
740925|NCT00096278|P2|Participant Flow|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
740926|NCT00096278|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
740927|NCT00096278|O2|Outcome|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
740928|NCT00096278|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
740929|NCT00096278|E2|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
740930|NCT00096278|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
740931|NCT00096265|B4|Baseline|Total|Total of all reporting groups
740932|NCT00096265|B3|Baseline|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740933|NCT00096265|B2|Baseline|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740934|NCT00096265|B1|Baseline|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740935|NCT00096265|P3|Participant Flow|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740936|NCT00096265|P2|Participant Flow|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740937|NCT00096265|P1|Participant Flow|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740938|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740939|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740940|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740941|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740942|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740943|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740944|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740945|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740946|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740947|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740948|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740949|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740950|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740951|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740952|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740953|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
740954|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
740955|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740956|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
742886|NCT00092677|O2|Outcome|Placebo|
740957|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
740958|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
740959|NCT00096265|E3|Reported Event|Erlotinib+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. [Data is reported for eligible patients with adverse event information, which is 41 patients.]
740960|NCT00096265|E2|Reported Event|Temozolomide+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. [Data is reported for eligible patients with adverse event information, which is 39 patients.]
740961|NCT00096265|E1|Reported Event|WBRT+SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. [Data is reported for eligible patients with adverse event information, which is 44 patients.]
740962|NCT00096226|B1|Baseline|Chemoradiation, Surgery, Chemotherapy|"Chemoradiation, surgery, chemotherapy~carboplatin~paclitaxel~adjuvant therapy~conventional surgery~neoadjuvant therapy~radiation therapy"
740963|NCT00096226|P1|Participant Flow|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
740964|NCT00096226|O1|Outcome|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
740965|NCT00096226|E1|Reported Event|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
740966|NCT00096200|B4|Baseline|Total|Total of all reporting groups
740967|NCT00096200|B3|Baseline|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
740968|NCT00096200|B2|Baseline|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
740969|NCT00096200|B1|Baseline|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
740970|NCT00096200|P3|Participant Flow|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
740971|NCT00096200|P2|Participant Flow|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
740972|NCT00096200|P1|Participant Flow|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
740973|NCT00096200|O3|Outcome|Arm C: Crossover From Arm A to B|Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
740974|NCT00096200|O2|Outcome|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
740975|NCT00096200|O1|Outcome|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
740976|NCT00096200|E3|Reported Event|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
740977|NCT00096200|E2|Reported Event|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
740978|NCT00096200|E1|Reported Event|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
740994|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741057|NCT00096018|B2|Baseline|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
740979|NCT00096174|B1|Baseline|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
740980|NCT00096174|P1|Participant Flow|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
740981|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
740982|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
740983|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
740984|NCT00096174|E1|Reported Event|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
740985|NCT00096161|B5|Baseline|Total|Total of all reporting groups
740986|NCT00096161|B4|Baseline|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740987|NCT00096161|B3|Baseline|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740988|NCT00096161|B2|Baseline|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740989|NCT00096161|B1|Baseline|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740990|NCT00096161|P4|Participant Flow|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740991|NCT00096161|P3|Participant Flow|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740992|NCT00096161|P2|Participant Flow|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740993|NCT00096161|P1|Participant Flow|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740995|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740996|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740997|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740998|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
740999|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741000|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741001|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741002|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741003|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741004|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741005|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741006|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741007|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741008|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741009|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741010|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741050|NCT00096031|B1|Baseline|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
741051|NCT00096031|P1|Participant Flow|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
741011|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741012|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741013|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741014|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741015|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741016|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741017|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741018|NCT00096161|E4|Reported Event|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741019|NCT00096161|E3|Reported Event|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741020|NCT00096161|E2|Reported Event|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741021|NCT00096161|E1|Reported Event|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
741022|NCT00096135|B3|Baseline|Total|Total of all reporting groups
741023|NCT00096135|B2|Baseline|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741024|NCT00096135|B1|Baseline|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741025|NCT00096135|P2|Participant Flow|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741026|NCT00096135|P1|Participant Flow|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741052|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
741053|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
741027|NCT00096135|O2|Outcome|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741028|NCT00096135|O1|Outcome|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741029|NCT00096135|E2|Reported Event|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741030|NCT00096135|E1|Reported Event|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
741031|NCT00096122|B1|Baseline|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
741032|NCT00096122|P1|Participant Flow|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
741033|NCT00096122|O1|Outcome|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
741034|NCT00096122|E1|Reported Event|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
741035|NCT00096109|B1|Baseline|Treatment (Tanespimycin)|Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
741036|NCT00096109|P1|Participant Flow|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
741037|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
741038|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
741039|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
741040|NCT00096109|E1|Reported Event|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~tanespimycin: Given IV~laboratory biomarker analysis: Correlative studies"
741041|NCT00096044|B1|Baseline|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741042|NCT00096044|P1|Participant Flow|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741043|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741044|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741045|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741046|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741047|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741048|NCT00096044|O1|Outcome|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741049|NCT00096044|E1|Reported Event|Oral Lenalidomide|"Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity~rituximab: IV~lenalidomide: Oral"
741058|NCT00096018|B1|Baseline|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741059|NCT00096018|P2|Participant Flow|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741060|NCT00096018|P1|Participant Flow|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741061|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741062|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741063|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741064|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741065|NCT00096018|E2|Reported Event|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741066|NCT00096018|E1|Reported Event|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
741067|NCT00095979|B1|Baseline|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
741068|NCT00095979|P1|Participant Flow|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
741069|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
741070|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
741071|NCT00095979|O5|Outcome|Grade 5|Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
741072|NCT00095979|O4|Outcome|Grade 4|Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
741073|NCT00095979|O3|Outcome|Grade 3|Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
741074|NCT00095979|O2|Outcome|Grade 2|Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
741075|NCT00095979|O1|Outcome|Grade 1|Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
741076|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
741077|NCT00095979|E1|Reported Event|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
741078|NCT00095940|B8|Baseline|Total|Total of all reporting groups
741079|NCT00095940|B7|Baseline|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
741080|NCT00095940|B6|Baseline|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
741081|NCT00095940|B5|Baseline|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
741082|NCT00095940|B4|Baseline|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
741083|NCT00095940|B3|Baseline|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
741084|NCT00095940|B2|Baseline|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
741085|NCT00095940|B1|Baseline|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
741086|NCT00095940|P9|Participant Flow|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
741087|NCT00095940|P8|Participant Flow|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
741088|NCT00095940|P7|Participant Flow|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
741089|NCT00095940|P6|Participant Flow|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
741136|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741137|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741090|NCT00095940|P5|Participant Flow|High Grade Glioma: No Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
741091|NCT00095940|P4|Participant Flow|High Grade Glioma: Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
741092|NCT00095940|P3|Participant Flow|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
741093|NCT00095940|P2|Participant Flow|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
741094|NCT00095940|P1|Participant Flow|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
741095|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
741096|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
741097|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
741098|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
741099|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
741100|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
741101|NCT00095940|O1|Outcome|Lapatinib: No Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment
741102|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
741103|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
741104|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
741105|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
741106|NCT00095940|O2|Outcome|No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
741107|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
741108|NCT00095940|E7|Reported Event|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
741109|NCT00095940|E6|Reported Event|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
741110|NCT00095940|E5|Reported Event|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
741111|NCT00095940|E4|Reported Event|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment.
741112|NCT00095940|E3|Reported Event|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment.
741113|NCT00095940|E2|Reported Event|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery.
741114|NCT00095940|E1|Reported Event|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
741115|NCT00095875|B3|Baseline|Total|Total of all reporting groups
741116|NCT00095875|B2|Baseline|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
741138|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741139|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741117|NCT00095875|B1|Baseline|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
741118|NCT00095875|P2|Participant Flow|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
741119|NCT00095875|P1|Participant Flow|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
741120|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
741121|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
741122|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
741123|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
741124|NCT00095875|E2|Reported Event|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
741125|NCT00095875|E1|Reported Event|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
741126|NCT00095836|B1|Baseline|Gefitinib 250mg|Gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
741127|NCT00095836|P1|Participant Flow|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
741128|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
741129|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
741130|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
741131|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
741132|NCT00095836|E1|Reported Event|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
741133|NCT00095784|B1|Baseline|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741134|NCT00095784|P1|Participant Flow|Decitabine|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741135|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741140|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741141|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741142|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741143|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741144|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741145|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741146|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741147|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741148|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741149|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741150|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741151|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741152|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741153|NCT00095784|O1|Outcome|Arm I|"Patients receive decitabine subcutaneously on days 1-5 and 8-12.~decitabine: Given SC"
741154|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741155|NCT00095784|E1|Reported Event|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
741156|NCT00095628|B1|Baseline|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741157|NCT00095628|P1|Participant Flow|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741158|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741159|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741160|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741161|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741162|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741163|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741164|NCT00095628|E1|Reported Event|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
741165|NCT00095576|B3|Baseline|Total|Total of all reporting groups
741166|NCT00095576|B2|Baseline|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
741167|NCT00095576|B1|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
741168|NCT00095576|P2|Participant Flow|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
741169|NCT00095576|P1|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
741170|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
741171|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
741172|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
741208|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741209|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741173|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
741174|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
741175|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
741176|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
741177|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
741178|NCT00095576|E2|Reported Event|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
741179|NCT00095576|E1|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
741180|NCT00095563|B1|Baseline|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741181|NCT00095563|P1|Participant Flow|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741182|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741183|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741184|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741185|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741186|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741187|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741188|NCT00095563|E1|Reported Event|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
741189|NCT00095498|B4|Baseline|Total|Total of all reporting groups
741190|NCT00095498|B3|Baseline|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741191|NCT00095498|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741192|NCT00095498|B1|Baseline|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741193|NCT00095498|P3|Participant Flow|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741194|NCT00095498|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741195|NCT00095498|P1|Participant Flow|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741196|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741197|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741198|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741199|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741200|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741201|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741202|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741203|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741204|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741205|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741206|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741207|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741210|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741211|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741212|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741213|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741214|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741215|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741216|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741217|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741218|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741219|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741220|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741221|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741222|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741223|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741224|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741225|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741226|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741227|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741228|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741229|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741230|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741231|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741232|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741233|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741234|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741235|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741236|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741237|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741238|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741239|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741240|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741241|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741242|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741243|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741244|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741245|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741246|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741247|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741248|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741249|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741250|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741251|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741252|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741253|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741254|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741255|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741256|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741257|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741258|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741259|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741260|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741261|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741262|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741263|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741264|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741265|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741266|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741267|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741268|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741269|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741270|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741271|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741272|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741273|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741274|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741275|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741276|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741277|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741278|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741279|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741280|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741281|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741282|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741283|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741284|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741285|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741286|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741287|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741288|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741289|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741290|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741291|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741292|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741293|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741294|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741295|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741296|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741297|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741298|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741299|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741300|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741301|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741302|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741303|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741304|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741305|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741306|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741307|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741308|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741309|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741310|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741311|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741312|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741313|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741314|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741315|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741316|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741317|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741318|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741319|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741320|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741321|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741322|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741323|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741324|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741325|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741326|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741327|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741328|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741329|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741330|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741331|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741332|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741333|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741334|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741335|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741336|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741337|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741338|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741339|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741340|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741341|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741342|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741343|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741344|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741345|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741346|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741347|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741348|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741349|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741350|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741351|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741352|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741353|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741354|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741355|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741356|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741357|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741358|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741359|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741360|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741361|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741362|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741363|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741364|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741365|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741366|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741367|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741368|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741369|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741370|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741371|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741372|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741373|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741374|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741375|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741376|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741377|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741378|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741379|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741380|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741381|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741382|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741383|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741384|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741385|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741386|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741387|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741388|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741389|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741390|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741391|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741392|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741393|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741394|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741395|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741396|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741397|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741398|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741399|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741400|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741401|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741402|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741403|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741404|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741405|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741406|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741407|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741408|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741409|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741410|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741411|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741412|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741413|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741414|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741415|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741416|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741417|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741418|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741419|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741420|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741421|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741422|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741423|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741424|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741425|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741426|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741427|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741428|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741429|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741430|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741431|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741432|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741433|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741434|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741435|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741436|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741437|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741438|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741439|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741440|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741441|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741442|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741443|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741444|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741445|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741446|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741447|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741448|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741449|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741450|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741451|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741452|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741453|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741454|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741455|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741456|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741457|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741458|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741459|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741460|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741461|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741462|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741463|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741464|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741465|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741466|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741467|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741468|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741469|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741470|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741471|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741472|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741473|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741474|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741475|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741476|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741477|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741478|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741479|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741480|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741481|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741482|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741483|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741484|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741485|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741486|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741487|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741488|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741489|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741490|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741491|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741492|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741493|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741494|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741495|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741496|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741497|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741498|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741499|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741500|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741501|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741502|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741503|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741504|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741505|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741506|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741507|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741508|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741509|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741510|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741511|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741512|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741513|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741514|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741515|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741516|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741517|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741518|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741519|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741520|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741521|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741522|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741523|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741524|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741525|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741526|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741527|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741528|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741529|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741530|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741531|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741532|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741533|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741534|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741535|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741536|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741537|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741538|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741539|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741540|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741541|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741542|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741543|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741544|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741545|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741546|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741547|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741548|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741549|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741550|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741551|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741552|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741553|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741554|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741555|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741556|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741557|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741558|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741559|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741560|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741561|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741562|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741563|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741564|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741565|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741566|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741567|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741568|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741569|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741570|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741571|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741572|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741573|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741574|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741575|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741576|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741577|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741578|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741579|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741580|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741581|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741582|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741583|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741584|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741585|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741586|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741587|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741588|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741589|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741590|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741591|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741592|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741593|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741594|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741595|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741596|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741597|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741598|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741599|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741600|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741601|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741602|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741603|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741604|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741605|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741606|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741607|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741608|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741609|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741610|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741611|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741612|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741613|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741614|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741615|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741616|NCT00095498|E3|Reported Event|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741617|NCT00095498|E2|Reported Event|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
741618|NCT00095498|E1|Reported Event|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
741619|NCT00095303|B3|Baseline|Total|Total of all reporting groups
741620|NCT00095303|B2|Baseline|TAU- Treatment as Usual|TAU: Treatment As Usual. Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
741621|NCT00095303|B1|Baseline|BSFT|BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members
741622|NCT00095303|P2|Participant Flow|Treatment as Usual|Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
741623|NCT00095303|P1|Participant Flow|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers : BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
741624|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741625|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741626|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741627|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741628|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741629|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741630|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741631|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741632|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741633|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741634|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741635|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741636|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741637|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741638|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741639|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741640|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741641|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741642|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741643|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741644|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741645|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741646|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741647|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741648|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741649|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741650|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741651|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741652|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741653|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741654|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741655|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741656|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741657|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741658|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741659|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741660|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741661|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741662|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741663|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741664|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741665|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741666|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741667|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741668|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741669|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741670|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741671|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741672|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741673|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741674|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741675|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741676|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741677|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741678|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741679|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741680|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741681|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741682|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741683|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741684|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
741685|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
741686|NCT00095303|E2|Reported Event|Treatment as Usual|Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
741687|NCT00095303|E1|Reported Event|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
741688|NCT00095238|B3|Baseline|Total|Total of all reporting groups
741689|NCT00095238|B2|Baseline|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741690|NCT00095238|B1|Baseline|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741691|NCT00095238|P2|Participant Flow|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741692|NCT00095238|P1|Participant Flow|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741693|NCT00095238|O4|Outcome|Placebo no ACE-I Use|
741694|NCT00095238|O3|Outcome|Irbesartan no ACE-I Use|
741695|NCT00095238|O2|Outcome|Placebo + ACE-I Use|
741696|NCT00095238|O1|Outcome|Irbesartan + ACE-I Use|
741697|NCT00095238|O6|Outcome|Irbesartan - Month 66|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 66
741698|NCT00095238|O5|Outcome|Placebo - Month 66|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 66
741699|NCT00095238|O4|Outcome|Irbesartan - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
741700|NCT00095238|O3|Outcome|Placebo - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
741701|NCT00095238|O2|Outcome|Irbesartan - Month 42|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 42
741702|NCT00095238|O1|Outcome|Placebo - Month 42|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 42
741703|NCT00095238|O6|Outcome|Irbesartan - Month 30|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 30
741704|NCT00095238|O5|Outcome|Placebo - Month 30|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 30
741705|NCT00095238|O4|Outcome|Irbesartan - Month 18|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 18
741706|NCT00095238|O3|Outcome|Placebo - Month 18|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 18
741707|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 6
741708|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 6
741709|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741710|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741711|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741712|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741713|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741714|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741715|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741716|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741717|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741718|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741719|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741720|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741721|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741722|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741723|NCT00095238|O6|Outcome|Placebo Baseline All Classes Combined|
741724|NCT00095238|O5|Outcome|Placebo Class III or IV|
741725|NCT00095238|O4|Outcome|Placebo Baseline Class I or II|
741726|NCT00095238|O3|Outcome|Irbesartan Baseline All Classes Combined|
741727|NCT00095238|O2|Outcome|Irbesartan Class III or IV|Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
741728|NCT00095238|O1|Outcome|Irbesartan Baseline Class I or II|Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
741729|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741730|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741731|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741732|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741733|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741734|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741735|NCT00095238|O4|Outcome|Irbesartan - Month 14|Irbesartan cohort with measurements at Baseline and Month 14.
741736|NCT00095238|O3|Outcome|Placebo - Month 14|Placebo cohort with measurements at Baseline and Month 14.
741737|NCT00095238|O2|Outcome|Irbesartan - Month 6|Irbesartan cohort with measurements at Baseline and Month 6.
741739|NCT00095238|O2|Outcome|Irbesartan - Final Visit|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Final Visit
741740|NCT00095238|O1|Outcome|Placebo - Final Visit|Cohort of participants in Placebo group with MLwHF scores at Baseline and Final Visit
741741|NCT00095238|O4|Outcome|Irbesartan - Month 14|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 14
741742|NCT00095238|O3|Outcome|Placebo - Month 14|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 14
741743|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 6
741744|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 6
741745|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741746|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741747|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
741748|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
741749|NCT00095238|E2|Reported Event|PLACEBO|titration from 75 to 300 mg, once daily (QD), up to 6 years
741750|NCT00095238|E1|Reported Event|IRBESARTAN|titration from 75 to 300 mg, once daily (QD), up to 6 years
741751|NCT00095212|B3|Baseline|Total|Total of all reporting groups
741752|NCT00095212|B2|Baseline|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741753|NCT00095212|B1|Baseline|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741754|NCT00095212|P2|Participant Flow|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741755|NCT00095212|P1|Participant Flow|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741756|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741757|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741758|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741759|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741760|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741761|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741762|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741763|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741764|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741765|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741766|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741767|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741768|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741769|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741770|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741771|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741772|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741773|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741774|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741775|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741776|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741777|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741778|NCT00095212|E2|Reported Event|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
741779|NCT00095212|E1|Reported Event|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
741780|NCT00095199|B5|Baseline|Total|Total of all reporting groups
741781|NCT00095199|B4|Baseline|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741782|NCT00095199|B3|Baseline|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741783|NCT00095199|B2|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741784|NCT00095199|B1|Baseline|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741785|NCT00095199|P4|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741786|NCT00095199|P3|Participant Flow|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741787|NCT00095199|P2|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
742887|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
741788|NCT00095199|P1|Participant Flow|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741789|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741790|NCT00095199|O3|Outcome|Cetuximab + Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Day 1 of every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
741791|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741792|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week cycles) until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741793|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741794|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week cycles).
741795|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741796|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
741797|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741798|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week cycles), after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741799|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741800|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741801|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741802|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741803|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741804|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741805|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741806|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741807|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741808|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
741809|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741810|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741811|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741812|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741813|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741814|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741815|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741816|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741817|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741818|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741819|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741820|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
741821|NCT00095199|E4|Reported Event|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741822|NCT00095199|E3|Reported Event|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
741823|NCT00095199|E2|Reported Event|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
741824|NCT00095199|E1|Reported Event|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
741825|NCT00095173|B1|Baseline|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.
741826|NCT00095173|P6|Participant Flow|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741827|NCT00095173|P5|Participant Flow|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741828|NCT00095173|P4|Participant Flow|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) or once a month for up to 5 years (Period C).
741829|NCT00095173|P3|Participant Flow|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
741830|NCT00095173|P2|Participant Flow|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare (Period B).
741831|NCT00095173|P1|Participant Flow|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
741832|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741833|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741834|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
741835|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741836|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
741837|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
741838|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses.
741839|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
742052|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741840|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741841|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
741842|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741843|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
741844|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
741845|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
741846|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741847|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741848|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
741849|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
741850|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
741851|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741852|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
741853|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
741854|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
741855|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
741856|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
741857|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
741858|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
741859|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
741860|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
741861|NCT00095173|E4|Reported Event|Abatacept (Period A)/Placebo (Period B)|"All participants treated with Abatacept in Period A, placebo in Period B, who may or may not have entered Period C.~Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion. If participants entered Period C, they were treated with Abatacept,10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years."
741862|NCT00095173|E3|Reported Event|Abatacept (Period A/Period B)|"All participants treated with Abatacept in Periods A and B who may or may not have entered Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses, then once a month for 6 months. If participants entered Period C, treatment continued once a month for up to 5 years."
742888|NCT00092677|O2|Outcome|Placebo|
741863|NCT00095173|E2|Reported Event|Abatacept (Period A/Period C)|"Participants treated in Period A, not eligible to continue into Period B, but re-entered in Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C)."
741864|NCT00095173|E1|Reported Event|Abatacept (Only Period A)|"Participants treated in Period A but did not in Periods B or C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses."
741865|NCT00095147|B4|Baseline|Total|Total of all reporting groups
741866|NCT00095147|B3|Baseline|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741867|NCT00095147|B2|Baseline|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741868|NCT00095147|B1|Baseline|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741869|NCT00095147|P5|Participant Flow|ABA + MTX [Open-label (OL)]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
741870|NCT00095147|P4|Participant Flow|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
741871|NCT00095147|P3|Participant Flow|Placebo (PLA) + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741872|NCT00095147|P2|Participant Flow|Infliximab (INF) + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741873|NCT00095147|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741874|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
741875|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
741876|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
741877|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741878|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741879|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741880|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741881|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741882|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741883|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741884|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741885|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741886|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741887|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741888|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741889|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741890|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742053|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741891|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741892|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741893|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741894|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741895|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741896|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741897|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741898|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741899|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741900|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741901|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741902|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741903|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741904|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741905|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741906|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741907|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741908|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741909|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741910|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741911|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741912|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741913|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741914|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741915|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741916|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741917|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742106|NCT00095121|O2|Outcome|Placebo (PLB)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group.
742689|NCT00093847|P1|Participant Flow|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
741918|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741919|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741920|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741921|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741922|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741923|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741924|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741925|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741926|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741927|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741928|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741929|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741930|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741931|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741932|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741933|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741934|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741935|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741936|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741937|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741938|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741939|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741940|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741941|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741942|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741943|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
741944|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742690|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
741945|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741946|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741947|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741948|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741949|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
741950|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741951|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741952|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
741953|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741954|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741955|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741956|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741957|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741958|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741959|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741960|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741961|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741962|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741963|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741964|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741965|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741966|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741967|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741968|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741969|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741970|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741971|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741972|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741973|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741974|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741975|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741976|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741977|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741978|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741979|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741980|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741981|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741982|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741983|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741984|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741985|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741986|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741987|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741988|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741989|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741990|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741991|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
741992|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741993|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741994|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741995|NCT00095147|O2|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
741996|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
741997|NCT00095147|O3|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
741998|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
741999|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742000|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742001|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742002|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742003|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742004|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742005|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742006|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742007|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742008|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742009|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742010|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742011|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742012|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742013|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742014|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742015|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
742016|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
742017|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
742018|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
742019|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742020|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742021|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742022|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742023|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742024|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742025|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742026|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742027|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742028|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742029|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742030|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742031|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742032|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742033|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742034|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742035|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742036|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742037|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742038|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742039|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742040|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742041|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742042|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742043|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742044|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742045|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742046|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742047|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742048|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742049|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742050|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742051|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742054|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742055|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742056|NCT00095147|O1|Outcome|ABA + MTX [DB[|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742057|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742058|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
742059|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
742060|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742061|NCT00095147|E4|Reported Event|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, 104 participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
742062|NCT00095147|E3|Reported Event|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly).
742063|NCT00095147|E2|Reported Event|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
742064|NCT00095147|E1|Reported Event|ABA (DB)|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
742065|NCT00095121|B3|Baseline|Total|Total of all reporting groups
742066|NCT00095121|B2|Baseline|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742067|NCT00095121|B1|Baseline|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742068|NCT00095121|P2|Participant Flow|PLB - ADV|Placebo (PLB) was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of open-label (OL) ADV treatment (ADV Week 192). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
742069|NCT00095121|P1|Participant Flow|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The adefovir dipivoxil (ADV) baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind [DB] ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
742070|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742071|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742107|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet.
742072|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742073|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742074|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742075|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742076|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742077|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742078|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742079|NCT00095121|O2|Outcome|Placebo (PBL)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the double-blind treatment period. RAT included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
742080|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment during the double-blind treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Randomized and Treated Analysis Set (RAT) included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
742081|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742082|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742146|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742147|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742083|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742084|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742085|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742086|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742087|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742088|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742089|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742090|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742091|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742092|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742148|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742149|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742691|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
742093|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742094|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742095|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742096|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742097|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742098|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742099|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742100|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742101|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742102|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742103|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742104|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
742105|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
742692|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
742108|NCT00095121|E4|Reported Event|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 - 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
742109|NCT00095121|E3|Reported Event|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 - 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
742110|NCT00095121|E2|Reported Event|PLB (Double-Blind)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the DB treatment period. Treatment-emergent AEs for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
742111|NCT00095121|E1|Reported Event|ADV (Double-Blind)|Once daily treatment during the DB treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Treatment-emergent adverse events (AEs) for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
742112|NCT00095056|B3|Baseline|Total|Total of all reporting groups
742113|NCT00095056|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742114|NCT00095056|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742115|NCT00095056|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742116|NCT00095056|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742117|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742118|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742119|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742120|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742121|NCT00095056|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742122|NCT00095056|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
742123|NCT00094900|B1|Baseline|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742124|NCT00094900|P1|Participant Flow|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742125|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742126|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742127|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742128|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742129|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742130|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742131|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742132|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742133|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742134|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742135|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742136|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742137|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742138|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742139|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742140|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742141|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742142|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742143|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742144|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742145|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742150|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742151|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742152|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742153|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742154|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742155|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742156|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742157|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742158|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742159|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742160|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742161|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742162|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742163|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742164|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742165|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742166|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742167|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742168|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742169|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742170|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742171|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742172|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742173|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742174|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742175|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742176|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742177|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742178|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742179|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742180|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742181|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742182|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742183|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742184|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742185|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742186|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742187|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742188|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742189|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742190|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742191|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742192|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742193|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742194|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742195|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742196|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742197|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742198|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742199|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742200|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742201|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742202|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742203|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742204|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742205|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742206|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742207|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742208|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742209|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742210|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742211|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742212|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742213|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742214|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742215|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742216|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742217|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742218|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742219|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742220|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742221|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742222|NCT00094900|E1|Reported Event|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
742223|NCT00094887|B3|Baseline|Total|Total of all reporting groups
742224|NCT00094887|B2|Baseline|Placebo|Nitrogen gas
742225|NCT00094887|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
742226|NCT00094887|P2|Participant Flow|Placebo|Nitrogen gas
742227|NCT00094887|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
742228|NCT00094887|O2|Outcome|Placebo|Nitrogen gas
742229|NCT00094887|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
742230|NCT00094887|E2|Reported Event|Placebo|Nitrogen gas
742231|NCT00094887|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
742232|NCT00094861|B3|Baseline|Total|Total of all reporting groups
742233|NCT00094861|B2|Baseline|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742693|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
742234|NCT00094861|B1|Baseline|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742235|NCT00094861|P2|Participant Flow|Palifermin|"Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
742236|NCT00094861|P1|Participant Flow|Placebo|"Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, for a total of 7 doses. Concurrent radio/chemotherapy was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
742237|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742238|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742239|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742240|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742241|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742242|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742243|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742244|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742245|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742246|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742247|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742248|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742249|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742250|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742251|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742252|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742253|NCT00094861|E2|Reported Event|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742254|NCT00094861|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
742255|NCT00094835|B8|Baseline|Total|Total of all reporting groups
742256|NCT00094835|B7|Baseline|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742257|NCT00094835|B6|Baseline|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742258|NCT00094835|B5|Baseline|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742259|NCT00094835|B4|Baseline|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742260|NCT00094835|B3|Baseline|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742261|NCT00094835|B2|Baseline|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742262|NCT00094835|B1|Baseline|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742263|NCT00094835|P7|Participant Flow|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742264|NCT00094835|P6|Participant Flow|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742265|NCT00094835|P5|Participant Flow|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742266|NCT00094835|P4|Participant Flow|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742267|NCT00094835|P3|Participant Flow|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742268|NCT00094835|P2|Participant Flow|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742269|NCT00094835|P1|Participant Flow|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742270|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742271|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742272|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742273|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742274|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742275|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742276|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742277|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742694|NCT00093847|E2|Reported Event|Oral Adjunct Placebo|Participants receiving placebo
742278|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742279|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742280|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742281|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742282|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742283|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742284|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742285|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742286|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742287|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742288|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742289|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742290|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742291|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742292|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742293|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742294|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742295|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742296|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742297|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742695|NCT00093847|E1|Reported Event|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
742298|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742299|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742300|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742301|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742302|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742303|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742304|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742305|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742306|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742307|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742308|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742309|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742310|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742311|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742312|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742313|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742314|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742315|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742316|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742317|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742403|NCT00094757|B3|Baseline|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
742318|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742319|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742320|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742321|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742322|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742323|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742324|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742325|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742326|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742327|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742328|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742329|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742330|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742331|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742332|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742333|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742334|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742335|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742336|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742337|NCT00094835|E7|Reported Event|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742889|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742890|NCT00092677|O2|Outcome|Placebo|
742338|NCT00094835|E6|Reported Event|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742339|NCT00094835|E5|Reported Event|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742340|NCT00094835|E4|Reported Event|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742341|NCT00094835|E3|Reported Event|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742342|NCT00094835|E2|Reported Event|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742343|NCT00094835|E1|Reported Event|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
742344|NCT00094809|B3|Baseline|Total|Total of all reporting groups
742345|NCT00094809|B2|Baseline|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742346|NCT00094809|B1|Baseline|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742347|NCT00094809|P2|Participant Flow|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742348|NCT00094809|P1|Participant Flow|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742349|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742350|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742351|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742352|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742353|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742354|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742355|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742356|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742357|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742358|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742359|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742360|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742361|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742362|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742363|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742364|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742365|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742366|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742367|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742368|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
742369|NCT00094809|E2|Reported Event|Pegfilgrastim|
742370|NCT00094809|E1|Reported Event|Placebo|
742371|NCT00094770|B3|Baseline|Total|Total of all reporting groups
742372|NCT00094770|B2|Baseline|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742373|NCT00094770|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742404|NCT00094757|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742374|NCT00094770|P2|Participant Flow|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742375|NCT00094770|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742376|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742377|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742378|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742379|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742380|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742381|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742382|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742383|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742384|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742385|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742386|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742387|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742388|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742389|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742390|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742391|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742392|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742393|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742394|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742395|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742396|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742397|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742398|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742399|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742400|NCT00094770|E2|Reported Event|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
742401|NCT00094770|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
742402|NCT00094757|B4|Baseline|Total|Total of all reporting groups
742891|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742892|NCT00092677|O2|Outcome|Placebo|
742405|NCT00094757|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742406|NCT00094757|P3|Participant Flow|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
742407|NCT00094757|P2|Participant Flow|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742408|NCT00094757|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742409|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
742410|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742411|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742412|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
742413|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742414|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742415|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
742416|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742417|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742418|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
742419|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742420|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742421|NCT00094757|E3|Reported Event|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
742422|NCT00094757|E2|Reported Event|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742423|NCT00094757|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
742424|NCT00094653|B4|Baseline|Total|Total of all reporting groups
742425|NCT00094653|B3|Baseline|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742426|NCT00094653|B2|Baseline|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742427|NCT00094653|B1|Baseline|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742428|NCT00094653|P3|Participant Flow|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742429|NCT00094653|P2|Participant Flow|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742430|NCT00094653|P1|Participant Flow|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742431|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742432|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742433|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742434|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742435|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742436|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742437|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742438|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742439|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742440|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742441|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742442|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742443|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742444|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742445|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742446|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742447|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742448|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742449|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742450|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742451|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742452|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742453|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742454|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742455|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742456|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742457|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742527|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742458|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742459|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742460|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742461|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742462|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742463|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742464|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742465|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742466|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742467|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742468|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742469|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742470|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742471|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742472|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742473|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742474|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742475|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742476|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742477|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742478|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742479|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742480|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742481|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742482|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742483|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742484|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742528|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742485|NCT00094653|O2|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742486|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742487|NCT00094653|E3|Reported Event|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742488|NCT00094653|E2|Reported Event|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742489|NCT00094653|E1|Reported Event|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
742490|NCT00094575|B3|Baseline|Total|Total of all reporting groups
742491|NCT00094575|B2|Baseline|Open Repair|Standard Open Repair
742492|NCT00094575|B1|Baseline|Endovascular Repair|Endovascular Repair
742493|NCT00094575|P2|Participant Flow|Open Repair|Standard Open Repair
742494|NCT00094575|P1|Participant Flow|Endovascular Repair|Endovascular Repair
742495|NCT00094575|O2|Outcome|Standard Open Repair|
742496|NCT00094575|O1|Outcome|Endovascular Repair|
742497|NCT00094575|O2|Outcome|Standard Open Repair|
742498|NCT00094575|O1|Outcome|Endovascular Repair|
742499|NCT00094575|O2|Outcome|Standard Open Repair|
742500|NCT00094575|O1|Outcome|Endovascular Repair|
742501|NCT00094575|O2|Outcome|Standard Open Repair|
742502|NCT00094575|O1|Outcome|Endovascular Repair|
742503|NCT00094575|O2|Outcome|Standard Open Repair|
742504|NCT00094575|O1|Outcome|Endovascular Repair|
742505|NCT00094575|O2|Outcome|Standard Open Repair|
742506|NCT00094575|O1|Outcome|Endovascular Repair|
742507|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
742508|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
742509|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
742510|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
742511|NCT00094575|E2|Reported Event|Open Repair|Standard Open Repair
742512|NCT00094575|E1|Reported Event|Endovascular Repair|Endovascular Repair
742513|NCT00094536|B1|Baseline|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
742514|NCT00094536|P1|Participant Flow|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
742515|NCT00094536|O1|Outcome|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
742516|NCT00094536|E1|Reported Event|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
742517|NCT00094497|B3|Baseline|Total|Total of all reporting groups
742518|NCT00094497|B2|Baseline|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742519|NCT00094497|B1|Baseline|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742520|NCT00094497|P2|Participant Flow|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742521|NCT00094497|P1|Participant Flow|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742522|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742523|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742524|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742525|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742526|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742529|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742530|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742531|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742532|NCT00094497|E2|Reported Event|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
742533|NCT00094497|E1|Reported Event|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
742534|NCT00094458|B4|Baseline|Total|Total of all reporting groups
742535|NCT00094458|B3|Baseline|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742536|NCT00094458|B2|Baseline|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742537|NCT00094458|B1|Baseline|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742538|NCT00094458|P6|Participant Flow|Infliximab + Azathioprine/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
742539|NCT00094458|P5|Participant Flow|Infliximab + Placebo/Infliximab|Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
742540|NCT00094458|P4|Participant Flow|Azathioprine + Placebo/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.
742541|NCT00094458|P3|Participant Flow|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742542|NCT00094458|P2|Participant Flow|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742543|NCT00094458|P1|Participant Flow|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742544|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742545|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742546|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742577|NCT00094458|E3|Reported Event|W30-Infliximab + Azathioprine|Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.
742578|NCT00094458|E2|Reported Event|W30-Infliximab + Placebo|Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.
742547|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742548|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742549|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742550|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742551|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742552|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742553|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742554|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742555|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742556|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742557|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742558|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742559|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742579|NCT00094458|E1|Reported Event|W30-Azathioprine + Placebo|Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.
742560|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742561|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742562|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742563|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742564|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742565|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742566|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742567|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742568|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742569|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742570|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
742571|NCT00094458|E9|Reported Event|OLE-Infliximab + Azathioprine/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
742572|NCT00094458|E8|Reported Event|OLE-Infliximab + Placebo/Infliximab|Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
742573|NCT00094458|E7|Reported Event|OLE-Azathioprine + Placebo/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
742574|NCT00094458|E6|Reported Event|W50-Infliximab + Azathioprine|Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
742575|NCT00094458|E5|Reported Event|W50-Infliximab + Placebo|Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
742576|NCT00094458|E4|Reported Event|W50-Azathioprine + Placebo|(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.
742580|NCT00094328|B1|Baseline|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742581|NCT00094328|P1|Participant Flow|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742582|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742583|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742584|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742585|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742586|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742587|NCT00094328|E1|Reported Event|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
742588|NCT00094302|B3|Baseline|Total|Total of all reporting groups
742589|NCT00094302|B2|Baseline|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742590|NCT00094302|B1|Baseline|Placebo|Placebo of spironolactone
742591|NCT00094302|P2|Participant Flow|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742592|NCT00094302|P1|Participant Flow|Placebo|Placebo of spironolactone
742593|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742594|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742595|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742596|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742597|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742598|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742599|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742600|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742601|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742602|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742603|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742604|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742605|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742606|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742607|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742608|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742609|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742610|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742611|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742612|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742651|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
742652|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
742653|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
742613|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742614|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742615|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742616|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742617|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742618|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742619|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742620|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742621|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742622|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742623|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742624|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742625|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742626|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742627|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742628|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742629|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742630|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742631|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742632|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742633|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742634|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742635|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742636|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742637|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742638|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742639|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742640|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742641|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742642|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
742643|NCT00094302|E2|Reported Event|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
742644|NCT00094302|E1|Reported Event|Placebo|Placebo of spironolactone
742645|NCT00094172|B3|Baseline|Total|Total of all reporting groups
742646|NCT00094172|B2|Baseline|Placebo|Non-Active Comparator
742647|NCT00094172|B1|Baseline|Atorvastatin|Drug: Atorvastatin
742648|NCT00094172|P2|Participant Flow|Placebo|Non-Active Comparator
742649|NCT00094172|P1|Participant Flow|Atorvastatin|Drug: Atorvastatin
742650|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
742658|NCT00094107|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742659|NCT00094107|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742660|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742661|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742662|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742663|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742664|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742665|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742666|NCT00094107|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
742667|NCT00094094|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742668|NCT00094094|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742669|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742670|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742671|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742672|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742673|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742674|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742675|NCT00094094|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742676|NCT00094055|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742677|NCT00094055|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742678|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742679|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742680|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742681|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742682|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742683|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742684|NCT00094055|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
742685|NCT00093847|B3|Baseline|Total|Total of all reporting groups
742686|NCT00093847|B2|Baseline|Oral Adjunct Placebo|Participants receiving placebo
742687|NCT00093847|B1|Baseline|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
742688|NCT00093847|P2|Participant Flow|Oral Adjunct Placebo|Participants receiving placebo
742696|NCT00093808|B1|Baseline|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
742697|NCT00093808|P1|Participant Flow|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
742698|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
742699|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
742700|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
742701|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
742702|NCT00093808|E1|Reported Event|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
742703|NCT00093795|B4|Baseline|Total|Total of all reporting groups
742704|NCT00093795|B3|Baseline|AC X 4 Then PG X 4|Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
742705|NCT00093795|B2|Baseline|AC X 4 Then P X 4|Doxorubicin, cyclophosphamide, and paclitaxel Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
742706|NCT00093795|B1|Baseline|TAC X 6|Doxorubicin, cyclophosphamide, and docetaxel. Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
742707|NCT00093795|P3|Participant Flow|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742708|NCT00093795|P2|Participant Flow|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742709|NCT00093795|P1|Participant Flow|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742710|NCT00093795|O3|Outcome|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742711|NCT00093795|O2|Outcome|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742712|NCT00093795|O1|Outcome|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742893|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742894|NCT00092677|E2|Reported Event|Placebo|
742713|NCT00093795|O3|Outcome|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742714|NCT00093795|O2|Outcome|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742715|NCT00093795|O1|Outcome|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742716|NCT00093795|O3|Outcome|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742717|NCT00093795|O2|Outcome|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742718|NCT00093795|O1|Outcome|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742719|NCT00093795|O3|Outcome|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742720|NCT00093795|O2|Outcome|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742721|NCT00093795|O1|Outcome|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742722|NCT00093795|O3|Outcome|Group 3: AC X 4 Then PG X 4|"Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742723|NCT00093795|O2|Outcome|Group 2: AC X 4 Then P X 4|"Doxorubicin, cyclophosphamide, and paclitaxel~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742724|NCT00093795|O1|Outcome|Group 1: TAC X 6|"Doxorubicin, cyclophosphamide, and docetaxel.~Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles~Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles~Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles~Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles"
742725|NCT00093795|E3|Reported Event|AC X 4 Then PG X 4|AC X 4 then PG X 4
742726|NCT00093795|E2|Reported Event|AC X 4 Then P X 4|AC X 4 then P X 4
742727|NCT00093795|E1|Reported Event|TAC X 6|TAC X 6
742728|NCT00093782|B1|Baseline|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742729|NCT00093782|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742730|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742731|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742895|NCT00092677|E1|Reported Event|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742896|NCT00092547|B3|Baseline|Total|Total of all reporting groups
742732|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742733|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742734|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742735|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742736|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742737|NCT00093782|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
742738|NCT00093756|B3|Baseline|Total|Total of all reporting groups
742739|NCT00093756|B2|Baseline|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
742740|NCT00093756|B1|Baseline|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
742741|NCT00093756|P2|Participant Flow|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
742742|NCT00093756|P1|Participant Flow|Phase I|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
742743|NCT00093756|O1|Outcome|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
742744|NCT00093756|O1|Outcome|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
742745|NCT00093756|O1|Outcome|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
742746|NCT00093756|O1|Outcome|Phase II|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
742747|NCT00093756|O1|Outcome|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
742748|NCT00093756|O1|Outcome|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
742749|NCT00093756|E2|Reported Event|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
742750|NCT00093756|E1|Reported Event|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
742751|NCT00093496|B3|Baseline|Total|Total of all reporting groups
742752|NCT00093496|B2|Baseline|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742753|NCT00093496|B1|Baseline|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742754|NCT00093496|P2|Participant Flow|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
743401|NCT00091507|P1|Participant Flow|GIK --|GIK = glucose-insulin-potassium
742755|NCT00093496|P1|Participant Flow|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742756|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742757|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742758|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742759|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742760|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742761|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742762|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742763|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
742764|NCT00093496|E1|Reported Event|All Patients Receiving Gemcitabine|All patients receiving gemcitabine were combined to analyze toxicity.
742765|NCT00093470|B3|Baseline|Total|Total of all reporting groups
742766|NCT00093470|B2|Baseline|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
742767|NCT00093470|B1|Baseline|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
742768|NCT00093470|P2|Participant Flow|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
742769|NCT00093470|P1|Participant Flow|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
742770|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
742771|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
742772|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
742773|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
742774|NCT00093470|E2|Reported Event|Arm B (Clinical Observation)|Patients undergo observation only.
742775|NCT00093470|E1|Reported Event|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
742776|NCT00093379|B1|Baseline|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
742897|NCT00092547|B2|Baseline|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
742777|NCT00093379|P1|Participant Flow|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
742778|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
742779|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
742780|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
742781|NCT00093379|E1|Reported Event|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
742782|NCT00093145|B1|Baseline|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742783|NCT00093145|P1|Participant Flow|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742784|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742785|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742786|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742787|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742831|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742832|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742788|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742789|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742790|NCT00093145|E1|Reported Event|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
742791|NCT00093041|B7|Baseline|Total|Total of all reporting groups
742792|NCT00093041|B6|Baseline|Zalutumumab 8 mg/kg|
742793|NCT00093041|B5|Baseline|Zalutumumab 4 mg/kg|
742794|NCT00093041|B4|Baseline|Zalutumumab 2 mg/kg|
742795|NCT00093041|B3|Baseline|Zalutumumab 1 mg/kg|
742796|NCT00093041|B2|Baseline|Zalutumumab 0.5 mg/kg|
742797|NCT00093041|B1|Baseline|Zalutumumab 0.15 mg/kg|
742798|NCT00093041|P6|Participant Flow|Zalutumumab 8 mg/kg|
742799|NCT00093041|P5|Participant Flow|Zalutumumab 4 mg/kg|
742800|NCT00093041|P4|Participant Flow|Zalutumumab 2 mg/kg|
742801|NCT00093041|P3|Participant Flow|Zalutumumab 1 mg/kg|
742802|NCT00093041|P2|Participant Flow|Zalutumumab 0.5 mg/kg|
742803|NCT00093041|P1|Participant Flow|Zalutumumab 0.15 mg/kg|
742804|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
742805|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
742806|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
742807|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
742808|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
742809|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
742810|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
742811|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
742812|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
742813|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
742814|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
742815|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
742816|NCT00093041|E6|Reported Event|Zalutumumab 8 mg/kg|
742817|NCT00093041|E5|Reported Event|Zalutumumab 4 mg/kg|
742818|NCT00093041|E4|Reported Event|Zalutumumab 2 mg/kg|
742819|NCT00093041|E3|Reported Event|Zalutumumab 1 mg/kg|
742820|NCT00093041|E2|Reported Event|Zalutumumab 0.5 mg/kg|
742821|NCT00093041|E1|Reported Event|Zalutumumab 0.15 mg/kg|
742822|NCT00093015|B3|Baseline|Total|Total of all reporting groups
742823|NCT00093015|B2|Baseline|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742824|NCT00093015|B1|Baseline|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742825|NCT00093015|P2|Participant Flow|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742826|NCT00093015|P1|Participant Flow|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742827|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742828|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742829|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742830|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742879|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742880|NCT00092677|O2|Outcome|Placebo|
742881|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742833|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742834|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742835|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742836|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742837|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742838|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742839|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742840|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742841|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742842|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742843|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742844|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742845|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742846|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742847|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
742848|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
742849|NCT00093015|E2|Reported Event|Darbepoetin Alfa|
742850|NCT00093015|E1|Reported Event|Placebo|
742851|NCT00092677|B3|Baseline|Total|Total of all reporting groups
742852|NCT00092677|B2|Baseline|Placebo|
742853|NCT00092677|B1|Baseline|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742854|NCT00092677|P2|Participant Flow|Placebo|
742855|NCT00092677|P1|Participant Flow|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742856|NCT00092677|O2|Outcome|Placebo|
742857|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742858|NCT00092677|O2|Outcome|Placebo|
742859|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742860|NCT00092677|O2|Outcome|Placebo|
742861|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742862|NCT00092677|O2|Outcome|Placebo|
742863|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742864|NCT00092677|O2|Outcome|Placebo|
742865|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742866|NCT00092677|O2|Outcome|Placebo|
742867|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742868|NCT00092677|O2|Outcome|Placebo|
742869|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742870|NCT00092677|O2|Outcome|Placebo|
742871|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742872|NCT00092677|O2|Outcome|Placebo|
742873|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742874|NCT00092677|O2|Outcome|Placebo|
742875|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742876|NCT00092677|O2|Outcome|Placebo|
742877|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
742878|NCT00092677|O2|Outcome|Placebo|
742898|NCT00092547|B1|Baseline|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742899|NCT00092547|P3|Participant Flow|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742900|NCT00092547|P2|Participant Flow|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
742901|NCT00092547|P1|Participant Flow|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
742902|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742903|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742904|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742905|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742906|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742907|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742908|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742909|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represent participants randomized to the qHPV vaccine group
742910|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742911|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742912|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742913|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742914|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742915|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742916|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742917|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742918|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742919|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742920|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742921|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742922|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742923|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742924|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742925|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742926|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742927|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742928|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742929|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742930|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742931|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742932|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
742933|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742934|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
742935|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742936|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
742937|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
742938|NCT00092547|E4|Reported Event|qHPV Vaccine in Extension: Extension and Long-term Follow-up|Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
742939|NCT00092547|E3|Reported Event|qHPV Vaccine in Base: Extension and Long-term Follow-up|Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
742940|NCT00092547|E2|Reported Event|Placebo in Base: Vaccine Phase and Follow-up|"Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup.~Adverse events are reported for this group from Day 1 to Month 30."
742941|NCT00092547|E1|Reported Event|qHPV Vaccine in Base: Vaccine Phase and Follow-up|Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.
742942|NCT00092534|B3|Baseline|Total|Total of all reporting groups
742943|NCT00092534|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742944|NCT00092534|B1|Baseline|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742945|NCT00092534|P3|Participant Flow|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
742946|NCT00092534|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742947|NCT00092534|P1|Participant Flow|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742948|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742949|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742950|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742951|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742952|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742953|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742954|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742955|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742956|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742957|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742958|NCT00092534|E3|Reported Event|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.~Extension study includes subjects from Group 2-Base Study who were vaccinated with quadrivalent HPV vaccine.~No data on non-serious adverse events were collected on this group during the extension study, hence no data are entered for them in the table."
742959|NCT00092534|E2|Reported Event|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742960|NCT00092534|E1|Reported Event|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742961|NCT00092521|B4|Baseline|Total|Total of all reporting groups
742962|NCT00092521|B3|Baseline|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742963|NCT00092521|B2|Baseline|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742964|NCT00092521|B1|Baseline|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742981|NCT00092495|B1|Baseline|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743029|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743030|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
743031|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743170|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
742965|NCT00092521|P4|Participant Flow|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
742966|NCT00092521|P3|Participant Flow|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742967|NCT00092521|P2|Participant Flow|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.~Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."
742968|NCT00092521|P1|Participant Flow|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742969|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742970|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742971|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742972|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742973|NCT00092521|E4|Reported Event|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
742974|NCT00092521|E3|Reported Event|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742975|NCT00092521|E2|Reported Event|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742976|NCT00092521|E1|Reported Event|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
742977|NCT00092495|B5|Baseline|Total|Total of all reporting groups
742978|NCT00092495|B4|Baseline|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742979|NCT00092495|B3|Baseline|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
742980|NCT00092495|B2|Baseline|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742982|NCT00092495|P5|Participant Flow|Extension Study|"Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as Completed Period are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
742983|NCT00092495|P4|Participant Flow|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742984|NCT00092495|P3|Participant Flow|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
742985|NCT00092495|P2|Participant Flow|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742986|NCT00092495|P1|Participant Flow|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
742987|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742988|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
742989|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742990|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
742991|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742992|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
742993|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
742994|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
742995|NCT00092495|O3|Outcome|Women 16-23 Years|
742996|NCT00092495|O2|Outcome|Boys 10-15 Years|
742997|NCT00092495|O1|Outcome|Girls 10-15 Years|
742998|NCT00092495|O3|Outcome|Women 16-23 Years|
742999|NCT00092495|O2|Outcome|Boys 10-15 Years|
743000|NCT00092495|O1|Outcome|Girls 10-15 Years|
743001|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743002|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
743003|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743004|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743005|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743006|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
743007|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743008|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743009|NCT00092495|O3|Outcome|Women 16-23 Years|
743010|NCT00092495|O2|Outcome|Boys 10-15 Years|
743011|NCT00092495|O1|Outcome|Girls 10-15 Years|
743012|NCT00092495|O3|Outcome|Women 16-23 Years|
743013|NCT00092495|O2|Outcome|Boys 10-15 Years|
743014|NCT00092495|O1|Outcome|Girls 10-15 Years|
743015|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743016|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
743017|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743018|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743019|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743020|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
743021|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743022|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743023|NCT00092495|O3|Outcome|Women 16-23 Years|
743024|NCT00092495|O2|Outcome|Boys 10-15 Years|
743025|NCT00092495|O1|Outcome|Girls 10-15 Years|
743026|NCT00092495|O3|Outcome|Women 16-23 Years|
743027|NCT00092495|O2|Outcome|Boys 10-15 Years|
743032|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743033|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743034|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
743035|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
743036|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743037|NCT00092495|O3|Outcome|Women 16-23 Years|
743038|NCT00092495|O2|Outcome|Boys 10-15 Years|
743039|NCT00092495|O1|Outcome|Girls 10-15 Years|
743040|NCT00092495|O3|Outcome|Women 16-23 Years|
743041|NCT00092495|O2|Outcome|Boys 10-15 Years|
743042|NCT00092495|O1|Outcome|Girls 10-15 Years|
743043|NCT00092495|E4|Reported Event|100% Formulation|Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743044|NCT00092495|E3|Reported Event|60% Formulation|Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743045|NCT00092495|E2|Reported Event|40% Formulation|Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743046|NCT00092495|E1|Reported Event|20% Formulation|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
743047|NCT00092456|B5|Baseline|Total|Total of all reporting groups
743048|NCT00092456|B4|Baseline|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743049|NCT00092456|B3|Baseline|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743050|NCT00092456|B2|Baseline|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743051|NCT00092456|B1|Baseline|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743052|NCT00092456|P4|Participant Flow|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
743053|NCT00092456|P3|Participant Flow|RotaTeq™ Lot 3|Three oral doses (~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743054|NCT00092456|P2|Participant Flow|RotaTeq™ Lot 2|Three oral doses (~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743055|NCT00092456|P1|Participant Flow|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743056|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743057|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743058|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743059|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743060|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743061|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743062|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743063|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743064|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743065|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743171|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
743066|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743067|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743068|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743069|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743070|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743071|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743072|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743073|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743074|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743075|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743076|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743077|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743078|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743079|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743080|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743081|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743082|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743083|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743084|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743085|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743086|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743087|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743088|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743089|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743090|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743091|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743169|NCT00092118|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
743092|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743093|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743094|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743095|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743096|NCT00092456|E4|Reported Event|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743097|NCT00092456|E3|Reported Event|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743098|NCT00092456|E2|Reported Event|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743099|NCT00092456|E1|Reported Event|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
743100|NCT00092443|B3|Baseline|Total|Total of all reporting groups
743101|NCT00092443|B2|Baseline|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
743102|NCT00092443|B1|Baseline|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
743103|NCT00092443|P2|Participant Flow|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
743104|NCT00092443|P1|Participant Flow|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
743105|NCT00092443|O10|Outcome|Placebo Matching RotaTeq™ (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743106|NCT00092443|O9|Outcome|Placebo Matching RotaTeq™ (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743107|NCT00092443|O8|Outcome|Placebo Matching RotaTeq™ (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743108|NCT00092443|O7|Outcome|Placebo Matching RotaTeq™ (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743109|NCT00092443|O6|Outcome|Placebo Matching RotaTeq™ (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743110|NCT00092443|O5|Outcome|RotaTeq™ at Expiry Potency (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743111|NCT00092443|O4|Outcome|RotaTeq™ at Expiry Potency (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743112|NCT00092443|O3|Outcome|RotaTeq™ at Expiry Potency (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743113|NCT00092443|O2|Outcome|RotaTeq™ at Expiry Potency (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743114|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
743115|NCT00092443|O2|Outcome|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
743116|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
743117|NCT00092443|E2|Reported Event|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
743118|NCT00092443|E1|Reported Event|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
743119|NCT00092417|B3|Baseline|Total|Total of all reporting groups
743120|NCT00092417|B2|Baseline|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743121|NCT00092417|B1|Baseline|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743122|NCT00092417|P2|Participant Flow|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743123|NCT00092417|P1|Participant Flow|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743124|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743125|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743126|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743127|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743128|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743129|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743130|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743131|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743132|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743133|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743134|NCT00092417|E2|Reported Event|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
743135|NCT00092417|E1|Reported Event|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
743136|NCT00092131|B1|Baseline|Overall Study Population|All randomized patients
743137|NCT00092131|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
743138|NCT00092131|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
743139|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743140|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743141|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743142|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743143|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743144|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743145|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743146|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743147|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743148|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743149|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743150|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743151|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743152|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743153|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743154|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743155|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743156|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743157|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743158|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743159|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743160|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743161|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743162|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743163|NCT00092131|E2|Reported Event|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
743164|NCT00092131|E1|Reported Event|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
743165|NCT00092118|B3|Baseline|Total|Total of all reporting groups
743166|NCT00092118|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
743167|NCT00092118|B1|Baseline|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
743168|NCT00092118|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
743172|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
743173|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
743174|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
743175|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
743176|NCT00092118|E2|Reported Event|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
743177|NCT00092118|E1|Reported Event|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
743178|NCT00091962|B4|Baseline|Total|Total of all reporting groups
743179|NCT00091962|B3|Baseline|Non-Depressed Control|Observational only
743180|NCT00091962|B2|Baseline|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
743181|NCT00091962|B1|Baseline|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
743182|NCT00091962|P3|Participant Flow|Non-Depressed Control Group|
743183|NCT00091962|P2|Participant Flow|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
743184|NCT00091962|P1|Participant Flow|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
743185|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
743186|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
743187|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
743188|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
743189|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
743190|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
743191|NCT00091962|O3|Outcome|Non-Depressed Control Group|Non-depressed groups as Control to see the natural course of recovery after CABG
743192|NCT00091962|O2|Outcome|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
743193|NCT00091962|O1|Outcome|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
743194|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
743195|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
743196|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
743197|NCT00091962|E3|Reported Event|Non-Depressed Control|Non-depressed control group with no intervention
743198|NCT00091962|E2|Reported Event|Depressed Usual Care|"Usual care for depression by patients' PCP"
743199|NCT00091962|E1|Reported Event|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
743200|NCT00091949|B3|Baseline|Total|Total of all reporting groups
743201|NCT00091949|B2|Baseline|Placebo|placebo: an inactive substance
743202|NCT00091949|B1|Baseline|Pioglitazone|pioglitazone: a thiazolidinedione drug
743203|NCT00091949|P2|Participant Flow|Placebo|placebo: an inactive substance
743204|NCT00091949|P1|Participant Flow|Pioglitazone|pioglitazone: a thiazolidinedione drug
743205|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
743206|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
743207|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
743208|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
743209|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
743210|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
743211|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
743212|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
743213|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
743214|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
743215|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
743216|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
743217|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
743218|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
743219|NCT00091949|E2|Reported Event|Placebo|placebo: an inactive substance
743220|NCT00091949|E1|Reported Event|Pioglitazone|pioglitazone: a thiazolidinedione drug
743221|NCT00091832|B7|Baseline|Total|Total of all reporting groups
743222|NCT00091832|B6|Baseline|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743223|NCT00091832|B5|Baseline|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743224|NCT00091832|B4|Baseline|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743225|NCT00091832|B3|Baseline|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743226|NCT00091832|B2|Baseline|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743227|NCT00091832|B1|Baseline|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743228|NCT00091832|P6|Participant Flow|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743229|NCT00091832|P5|Participant Flow|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743230|NCT00091832|P4|Participant Flow|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743231|NCT00091832|P3|Participant Flow|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743232|NCT00091832|P2|Participant Flow|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743233|NCT00091832|P1|Participant Flow|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)
743234|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743235|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743236|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743237|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743238|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743239|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743240|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743241|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743242|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743243|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743244|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743245|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743246|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743247|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743248|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743249|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743250|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743251|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743252|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743253|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743254|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743255|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743256|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743257|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743258|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743259|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743260|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743261|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743262|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743263|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743264|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743265|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743266|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743267|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743268|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743269|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743270|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743271|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743272|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743273|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743274|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743275|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743276|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743277|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743278|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743397|NCT00091507|B3|Baseline|Total|Total of all reporting groups
743279|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743280|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743281|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743282|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743283|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743284|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743285|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743286|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743287|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743288|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743289|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743290|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743291|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743292|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743293|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743294|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743295|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743296|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743297|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743298|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743299|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743300|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743301|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743302|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743303|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743304|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743305|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743306|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743307|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743308|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743309|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743310|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743311|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743312|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743313|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743314|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743315|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743316|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743317|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743318|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743319|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743320|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743321|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743322|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743323|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743324|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743325|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743326|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743327|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743328|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743329|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743330|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743331|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743332|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743333|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743334|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743335|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743336|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743337|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743338|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743339|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743340|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743341|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
743342|NCT00091832|E6|Reported Event|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
743343|NCT00091832|E5|Reported Event|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
743344|NCT00091832|E4|Reported Event|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
743345|NCT00091832|E3|Reported Event|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
743346|NCT00091832|E2|Reported Event|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
743347|NCT00091832|E1|Reported Event|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.
743348|NCT00091819|B3|Baseline|Total|Total of all reporting groups
743349|NCT00091819|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
743350|NCT00091819|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
743351|NCT00091819|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
743352|NCT00091819|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
743353|NCT00091819|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
743354|NCT00091819|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
743355|NCT00091819|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
743356|NCT00091819|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
743357|NCT00091793|B3|Baseline|Total|Total of all reporting groups
743358|NCT00091793|B2|Baseline|Placebo|
743359|NCT00091793|B1|Baseline|Denosumab 60 mg Q6M|
743360|NCT00091793|P2|Participant Flow|Placebo|
743361|NCT00091793|P1|Participant Flow|Denosumab 60 mg Q6M|
743362|NCT00091793|O2|Outcome|Placebo|
743363|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743364|NCT00091793|O2|Outcome|Placebo|
743365|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743366|NCT00091793|O2|Outcome|Placebo|
743367|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743368|NCT00091793|O2|Outcome|Placebo|
743369|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743370|NCT00091793|O2|Outcome|Placebo|
743371|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743372|NCT00091793|O2|Outcome|Placebo|
743373|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743374|NCT00091793|O2|Outcome|Placebo|
743375|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743376|NCT00091793|O2|Outcome|Placebo|
743377|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743378|NCT00091793|O2|Outcome|Placebo|
743379|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
743380|NCT00091793|E2|Reported Event|Denosumab 60 mg Q6M|
743381|NCT00091793|E1|Reported Event|Placebo|
743382|NCT00091572|B3|Baseline|Total|Total of all reporting groups
743383|NCT00091572|B2|Baseline|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
743384|NCT00091572|B1|Baseline|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
743385|NCT00091572|P2|Participant Flow|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
743386|NCT00091572|P1|Participant Flow|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
743387|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
743388|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
743389|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
743390|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
743391|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
743392|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
743393|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
743394|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
743395|NCT00091572|E2|Reported Event|Dacarbazine|
743396|NCT00091572|E1|Reported Event|Temozolomide|
743413|NCT00091507|E1|Reported Event|GIK --|GIK = glucose-insulin-potassium
743414|NCT00091442|B3|Baseline|Total|Total of all reporting groups
743415|NCT00091442|B2|Baseline|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743416|NCT00091442|B1|Baseline|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743417|NCT00091442|P2|Participant Flow|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743418|NCT00091442|P1|Participant Flow|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743419|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743420|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743421|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743422|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743423|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743424|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743425|NCT00091442|E2|Reported Event|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743426|NCT00091442|E1|Reported Event|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
743427|NCT00091390|B1|Baseline|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
743428|NCT00091390|P1|Participant Flow|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
743429|NCT00091390|O1|Outcome|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
743430|NCT00091390|E1|Reported Event|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
743431|NCT00091273|B1|Baseline|Single Arm|
743432|NCT00091273|P1|Participant Flow|Single Arm|
743433|NCT00091273|O1|Outcome|Single Arm|
743434|NCT00091273|O1|Outcome|Single Arm|
743435|NCT00091273|O1|Outcome|Single Arm|
743436|NCT00091273|E1|Reported Event|Single Arm|
743437|NCT00091260|B1|Baseline|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
743438|NCT00091260|P1|Participant Flow|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
743439|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
743440|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
743441|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
743442|NCT00091260|E1|Reported Event|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
743443|NCT00091169|B3|Baseline|Total|Total of all reporting groups
743444|NCT00091169|B2|Baseline|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743445|NCT00091169|B1|Baseline|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743446|NCT00091169|P2|Participant Flow|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743447|NCT00091169|P1|Participant Flow|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743448|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743449|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743450|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743451|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743452|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743453|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743454|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743455|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743456|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743457|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743458|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
743459|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
743460|NCT00091169|E2|Reported Event|Placebo|Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
743461|NCT00091169|E1|Reported Event|Levocarnitine|Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally
743462|NCT00091026|B3|Baseline|Total|Total of all reporting groups
743463|NCT00091026|B2|Baseline|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
743464|NCT00091026|B1|Baseline|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
743465|NCT00091026|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
743466|NCT00091026|P1|Participant Flow|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
743467|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
743468|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
743469|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
743470|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
743471|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
743472|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
743473|NCT00091026|E2|Reported Event|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
743474|NCT00091026|E1|Reported Event|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
743475|NCT00090987|B1|Baseline|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
743476|NCT00090987|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
743477|NCT00090987|O1|Outcome|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
743478|NCT00090987|E1|Reported Event|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
743479|NCT00090857|B3|Baseline|Total|Total of all reporting groups
743480|NCT00090857|B2|Baseline|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743481|NCT00090857|B1|Baseline|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743482|NCT00090857|P2|Participant Flow|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743483|NCT00090857|P1|Participant Flow|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743540|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743484|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743485|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743486|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743487|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743488|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743489|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743490|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743491|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743492|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743493|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743494|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743495|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743496|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743497|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743498|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743499|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743500|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743501|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743502|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743503|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743541|NCT00090779|E2|Reported Event|DT Arm|DT arm participants received no Treatment
743542|NCT00090779|E1|Reported Event|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743543|NCT00090766|B4|Baseline|Total|Total of all reporting groups
743504|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743505|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743506|NCT00090857|O2|Outcome|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743507|NCT00090857|O1|Outcome|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743508|NCT00090857|E2|Reported Event|Placebo|Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743509|NCT00090857|E1|Reported Event|Letrozole|Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
743510|NCT00090844|B3|Baseline|Total|Total of all reporting groups
743511|NCT00090844|B2|Baseline|no Triptorelin|no GnRH analogue (triptorelin) during chemotherapy
743512|NCT00090844|B1|Baseline|Triptorelin|GnRH analogue (triptorelin) during chemotherapy
743513|NCT00090844|P2|Participant Flow|no Triptorelin|No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy
743514|NCT00090844|P1|Participant Flow|Triptorelin|"Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
743515|NCT00090844|O2|Outcome|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
743516|NCT00090844|O1|Outcome|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
743517|NCT00090844|E2|Reported Event|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
743518|NCT00090844|E1|Reported Event|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
743519|NCT00090779|B3|Baseline|Total|Total of all reporting groups
743520|NCT00090779|B2|Baseline|DT Arm|DT arm participants received no Treatment
743521|NCT00090779|B1|Baseline|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743522|NCT00090779|P2|Participant Flow|DT Arm|On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
743523|NCT00090779|P1|Participant Flow|IT Arm|On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
743524|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743525|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743526|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743527|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743528|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743529|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743530|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743531|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743532|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743533|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743534|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743535|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743536|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743537|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743538|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
743539|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
743544|NCT00090766|B3|Baseline|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743545|NCT00090766|B2|Baseline|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743546|NCT00090766|B1|Baseline|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743547|NCT00090766|P3|Participant Flow|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743548|NCT00090766|P2|Participant Flow|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743549|NCT00090766|P1|Participant Flow|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).
743550|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743551|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743552|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743553|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743554|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743555|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743556|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743557|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743558|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743559|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743560|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743561|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743562|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743563|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743564|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743603|NCT00090610|P1|Participant Flow|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
743565|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743566|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743567|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743568|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743569|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743570|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743571|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743572|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743573|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743574|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743575|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743576|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743577|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743578|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743579|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Participants aged >= 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose (in mg) was calculated using the algorithm (7 * body surface area * creatinine clearance).
743580|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743581|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743582|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743583|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743584|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743585|NCT00090766|E3|Reported Event|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743586|NCT00090766|E2|Reported Event|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743587|NCT00090766|E1|Reported Event|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
743588|NCT00090753|B3|Baseline|Total|Total of all reporting groups
743589|NCT00090753|B2|Baseline|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
743590|NCT00090753|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
743591|NCT00090753|P2|Participant Flow|Comparator ESA|Patients received the same comparator erythropoiesis stimulating agent (ESA) [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
743592|NCT00090753|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
743593|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
743594|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
743595|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
743596|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
743597|NCT00090753|E2|Reported Event|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
743598|NCT00090753|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
743599|NCT00090610|B3|Baseline|Total|Total of all reporting groups
743600|NCT00090610|B2|Baseline|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743601|NCT00090610|B1|Baseline|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
743602|NCT00090610|P2|Participant Flow|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743604|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743605|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
743606|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743607|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
743608|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743609|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
743610|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743611|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
743612|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743613|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
743614|NCT00090610|E2|Reported Event|Arm2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
743615|NCT00090610|E1|Reported Event|Arm 1|Docetaxel 30 mg/m2 intravenously (IV) on Days 1 and 8, combined with carboplatin area under the concentration versus time curve (AUC) 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression (DP) (whichever occurred first).
743616|NCT00090584|B3|Baseline|Total|Total of all reporting groups
743617|NCT00090584|B2|Baseline|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743618|NCT00090584|B1|Baseline|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743619|NCT00090584|P2|Participant Flow|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743620|NCT00090584|P1|Participant Flow|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743621|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743622|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743623|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743624|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743625|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743626|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743627|NCT00090584|O2|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
743628|NCT00090584|O1|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
743629|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
743630|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
743631|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
743632|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
743633|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
743634|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
743635|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
743636|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
743637|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
743638|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
743639|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
743640|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
743641|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743642|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743643|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743644|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743645|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743646|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743647|NCT00090584|E2|Reported Event|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
743691|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743648|NCT00090584|E1|Reported Event|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
743649|NCT00090519|B3|Baseline|Total|Total of all reporting groups
743650|NCT00090519|B2|Baseline|Placebo|QD oral for up to 36 months
743651|NCT00090519|B1|Baseline|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743652|NCT00090519|P2|Participant Flow|Placebo|QD oral for up to 36 months
743653|NCT00090519|P1|Participant Flow|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743654|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743655|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743656|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743657|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743658|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743659|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743660|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743661|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743662|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743663|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743664|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743665|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743666|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743667|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743668|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743669|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743670|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743671|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743672|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
743673|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743674|NCT00090519|E2|Reported Event|Placebo|QD oral for up to 36 months
743675|NCT00090519|E1|Reported Event|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
743676|NCT00090493|B1|Baseline|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|Treatment will consist of receiving peptide (small pieces of proteins) vaccinations as a shot just under the skin (subcutaneous). Purpose is to generate anti-myeloma T-cells with will kill only myeloma cells. Three injections of peptide will be given subcutaneously together with the adjuvant GM-CSF at 2-week intervals.
743677|NCT00090493|P1|Participant Flow|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
743678|NCT00090493|O1|Outcome|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
743679|NCT00090493|E1|Reported Event|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
743680|NCT00090363|B4|Baseline|Total|Total of all reporting groups
743681|NCT00090363|B3|Baseline|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743682|NCT00090363|B2|Baseline|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743683|NCT00090363|B1|Baseline|Placebo|Matching placebo oral tablet once daily, with best supportive care
743684|NCT00090363|P3|Participant Flow|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743685|NCT00090363|P2|Participant Flow|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743686|NCT00090363|P1|Participant Flow|Placebo|Matching placebo oral tablet once daily, with best supportive care
743687|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743688|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743689|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
743690|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743692|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
743693|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743694|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743695|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
743696|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743697|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743698|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
743699|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743700|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743701|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
743702|NCT00090363|E3|Reported Event|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
743703|NCT00090363|E2|Reported Event|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
743704|NCT00090363|E1|Reported Event|Placebo|Matching placebo oral tablet once daily, with best supportive care
743705|NCT00090545|B3|Baseline|Total|Total of all reporting groups
743706|NCT00090545|B2|Baseline|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles"
743707|NCT00090545|B1|Baseline|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743708|NCT00090545|P2|Participant Flow|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743709|NCT00090545|P1|Participant Flow|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743710|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743711|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743712|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743713|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743714|NCT00090545|E2|Reported Event|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743715|NCT00090545|E1|Reported Event|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
743716|NCT00090285|B3|Baseline|Total|Total of all reporting groups
743717|NCT00090285|B2|Baseline|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743718|NCT00090285|B1|Baseline|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743719|NCT00090285|P6|Participant Flow|LTFU (EXT2): Catch-up Vaccination Group|Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
743720|NCT00090285|P5|Participant Flow|LTFU (EXT2): Early Vaccination Group|Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
743721|NCT00090285|P4|Participant Flow|EXT1: Incomplete qHPV Regimen in Base Study|"Participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the Base Study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).~Participants were followed to EXT1 Month 7."
743722|NCT00090285|P3|Participant Flow|EXT1: Placebo in Base Study|"Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at Extension 1 (EXT1) Day 1, Month 2 and Month 6.~Participants were followed to EXT1 Month 7."
743723|NCT00090285|P2|Participant Flow|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743724|NCT00090285|P1|Participant Flow|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received quadrivalent human papillomavirus (qHPV) vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743725|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120."
743826|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
744224|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
743726|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120."
743727|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120."
743728|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120."
743729|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743730|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743731|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120."
743732|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study was through Month 36 and for LTFU (EXT2) was through Month 120."
743733|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743734|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743735|NCT00090285|O2|Outcome|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743736|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743737|NCT00090285|O2|Outcome|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743738|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743739|NCT00090285|O2|Outcome|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743740|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743741|NCT00090285|O2|Outcome|LTFU (EXT2): Catch-up Vaccination Group|Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
743742|NCT00090285|O1|Outcome|LTFU (EXT2): Early Vaccination Group|Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
743743|NCT00090285|O2|Outcome|LTFU (EXT2): Catch-up Vaccination Group|Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
743744|NCT00090285|O1|Outcome|LTFU (EXT2): Early Vaccination Group|Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
743745|NCT00090285|O2|Outcome|Placebo: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
743746|NCT00090285|O1|Outcome|qHPV Vaccine: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
743747|NCT00090285|O2|Outcome|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743748|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743749|NCT00090285|O1|Outcome|MSM qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743827|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743750|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743751|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
743752|NCT00090285|O2|Outcome|Placebo in Base Study|"The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743753|NCT00090285|O1|Outcome|qHPV Vaccine in Base Study|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the Base Study encompassed Month 7 through Month 36."
743754|NCT00090285|E4|Reported Event|LTFU (EXT2)|Participants received ≥1 dose of qHPV vaccine in Base Study, or received placebo in Base Study and qHPV vaccine in EXT1.
743755|NCT00090285|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).
743756|NCT00090285|E2|Reported Event|Placebo: Base Study|The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
743757|NCT00090285|E1|Reported Event|qHPV Vaccine: Base Study|The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
743758|NCT00090259|B3|Baseline|Total|Total of all reporting groups
743759|NCT00090259|B2|Baseline|Losartan 150 mg|
743760|NCT00090259|B1|Baseline|Losartan 50 mg|
743761|NCT00090259|P2|Participant Flow|Losartan 150 mg|
743762|NCT00090259|P1|Participant Flow|Losartan 50 mg|
743763|NCT00090259|O2|Outcome|Losartan 150 mg|
743764|NCT00090259|O1|Outcome|Losartan 50 mg|
743765|NCT00090259|O2|Outcome|Losartan 150 mg|
743766|NCT00090259|O1|Outcome|Losartan 50 mg|
743767|NCT00090259|O2|Outcome|Losartan 150 mg|
743768|NCT00090259|O1|Outcome|Losartan 50 mg|
743769|NCT00090259|O2|Outcome|Losartan 150 mg|
743770|NCT00090259|O1|Outcome|Losartan 50 mg|
743771|NCT00090259|O2|Outcome|Losartan 150 mg|
743772|NCT00090259|O1|Outcome|Losartan 50 mg|
743773|NCT00090259|E2|Reported Event|Losartan 150 mg|
743774|NCT00090259|E1|Reported Event|Losartan 50 mg|
743775|NCT00090233|B3|Baseline|Total|Total of all reporting groups
743776|NCT00090233|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743777|NCT00090233|B1|Baseline|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743778|NCT00090233|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
743779|NCT00090233|P1|Participant Flow|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
743780|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743781|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743782|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743783|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743784|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743785|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743786|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743787|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743788|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743789|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743790|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743791|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743828|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743792|NCT00090233|O2|Outcome|Placebo|The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
743793|NCT00090233|O1|Outcome|RotaTeq™|The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
743794|NCT00090233|O2|Outcome|Placebo|Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
743795|NCT00090233|O1|Outcome|RotaTeq™|Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
743796|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743797|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
743798|NCT00090233|E2|Reported Event|Placebo|"Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
743799|NCT00090233|E1|Reported Event|RotaTeq™|"Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
743800|NCT00090220|B3|Baseline|Total|Total of all reporting groups
743801|NCT00090220|B2|Baseline|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743802|NCT00090220|B1|Baseline|qHPV Vaccine in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743803|NCT00090220|P6|Participant Flow|Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)|Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.
743804|NCT00090220|P5|Participant Flow|qHPV Vaccine in Base Study: LTFU (EXT2)|Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study
743805|NCT00090220|P4|Participant Flow|Incomplete qHPV Regimen in Base Study: EXT1|Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
743806|NCT00090220|P3|Participant Flow|Placebo in Base Study: EXT1|Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
743807|NCT00090220|P2|Participant Flow|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6
743808|NCT00090220|P1|Participant Flow|qHPV Vaccine in Base Study|Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6
743809|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743810|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743811|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743812|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743813|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743814|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743815|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743816|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743817|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
743818|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743819|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
743820|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743821|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743822|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743823|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743824|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743825|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743829|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
743830|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743831|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743832|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743833|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743834|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743835|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743836|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743837|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743838|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743839|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743840|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743841|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743842|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743843|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743844|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743845|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743846|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743847|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743848|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743849|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743850|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743851|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743852|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743853|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743854|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743855|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743856|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743857|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743858|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743859|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743860|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743861|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743862|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 35 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743863|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743864|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743865|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743866|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743867|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
744225|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
743868|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743869|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743870|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743871|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743872|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743873|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743874|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743875|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743876|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743877|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743878|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743879|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743880|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743881|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743882|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743883|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743884|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743885|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743886|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743887|NCT00090220|O2|Outcome|Base Study: Placebo|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
743888|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743889|NCT00090220|O2|Outcome|Placebo in Base Study|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
743890|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743891|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
743892|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743893|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
743894|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
743895|NCT00090220|E4|Reported Event|Long-term Follow-up: EXT2|Participants at sites in Colombia who received qHPV vaccination in the Base Study or in EXT1 were followed from Month 72 up to approximately Month 120 in LTFU (EXT2)
743896|NCT00090220|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo or an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine starting at approximately Month 60 (EXT1) and were followed up to Month 67
743897|NCT00090220|E2|Reported Event|Placebo: Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
743898|NCT00090220|E1|Reported Event|qHPV Vaccine: Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
743899|NCT00090402|B4|Baseline|Total|Total of all reporting groups
743900|NCT00090402|B3|Baseline|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
743901|NCT00090402|B2|Baseline|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
743902|NCT00090402|B1|Baseline|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
743903|NCT00090402|P3|Participant Flow|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
743904|NCT00090402|P2|Participant Flow|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
743905|NCT00090402|P1|Participant Flow|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
743906|NCT00090402|O3|Outcome|Fish Oil and Lipoic Acid|"Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).~Fish Oil and Lipoic acid: Fish oil concentrate(daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) plus lipoic acid (daily dose 600 milligrams)taken for 12 months"
743949|NCT00090103|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744226|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
743907|NCT00090402|O2|Outcome|Fish Oil|"Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.~Fish Oil: Fish oil concentrate (daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) taken for 12 months."
743908|NCT00090402|O1|Outcome|Placebo|"Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.~Placebo: Soybean oil 3 grams a day and placebo lipoic acid 600 milligrams a day taken for 12 months."
743909|NCT00090402|O3|Outcome|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
743910|NCT00090402|O2|Outcome|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
743911|NCT00090402|O1|Outcome|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
743912|NCT00090402|O3|Outcome|Fish Oil Plus Lipoic Acid|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
743913|NCT00090402|O2|Outcome|Fish Oil|Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
743914|NCT00090402|O1|Outcome|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
743915|NCT00090402|E3|Reported Event|Fish Oil Plus Lipoic Acid|Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).
743916|NCT00090402|E2|Reported Event|Fish Oil|Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
743917|NCT00090402|E1|Reported Event|Placebo|Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate
743918|NCT00090142|B1|Baseline|Overall Study Population|All randomized patients
743919|NCT00090142|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|"A montelukast matching-image placebo tablet (Treatment Period I) was taken~orally in the morning as a single witnessed dose. This was followed by a 3-7 day washout and then a~montelukast 10-mg tablet (Treatment Period II) was taken orally in the morning as a single witnessed dose."
743920|NCT00090142|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|"A montelukast 10-mg tablet (Treatment Period I) was taken orally in the~morning as a single witnessed dose. This was followed by a 3-7 day washout period and then a montelukast~matching-image placebo tablet (Treatment Period II) was taken orally in the morning as a single witnessed~dose."
743921|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743922|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743923|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743924|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743925|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743926|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743927|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743928|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743929|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743930|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743931|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743932|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743933|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743934|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743935|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743936|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743937|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743938|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743939|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743940|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743941|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743942|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743943|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
743944|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
743945|NCT00090142|E2|Reported Event|Placebo|
743946|NCT00090142|E1|Reported Event|Montelukast 10 mg|
743947|NCT00090103|B4|Baseline|Total|Total of all reporting groups
743948|NCT00090103|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743950|NCT00090103|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743951|NCT00090103|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743952|NCT00090103|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743953|NCT00090103|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743954|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743955|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743956|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743957|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743958|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743959|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743960|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743961|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743962|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743963|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743964|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743965|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743966|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743967|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743968|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743969|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743970|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743971|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743972|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743973|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743974|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743975|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743976|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743977|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743978|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743979|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743980|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743981|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743982|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743983|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743984|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743985|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743986|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743987|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743988|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743989|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743990|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743991|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743992|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743993|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743994|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743995|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743996|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
743997|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
743998|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
743999|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744000|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744001|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744002|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744003|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744004|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744005|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744006|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744007|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744008|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744009|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744010|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744011|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744012|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744013|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744014|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744015|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744016|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744017|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744018|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744019|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744020|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744021|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744022|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744023|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744024|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744025|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744026|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744027|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744028|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744029|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744030|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744031|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744032|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744033|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744034|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744035|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744036|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744037|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744038|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744039|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744040|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744041|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744042|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744043|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744044|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
744045|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
744046|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
744047|NCT00090103|E3|Reported Event|Tamsulosin 0.4 mg|
744048|NCT00090103|E2|Reported Event|Dutasteride 0.5 mg|
744049|NCT00090103|E1|Reported Event|Combination|
744050|NCT00090051|B3|Baseline|Total|Total of all reporting groups
744051|NCT00090051|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744052|NCT00090051|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744053|NCT00090051|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744054|NCT00090051|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744055|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744056|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744057|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744058|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744059|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744060|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744061|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744062|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744063|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744064|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744065|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744066|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744067|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744068|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744069|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744070|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744071|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744099|NCT00003224|P1|Participant Flow|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744072|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744073|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744074|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744075|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744076|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744077|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744078|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744079|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744080|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744081|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744082|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744083|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744084|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744085|NCT00090051|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
744086|NCT00090051|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
744087|NCT00003224|B7|Baseline|Total|Total of all reporting groups
744088|NCT00003224|B6|Baseline|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744089|NCT00003224|B5|Baseline|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744090|NCT00003224|B4|Baseline|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744091|NCT00003224|B3|Baseline|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744092|NCT00003224|B2|Baseline|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744093|NCT00003224|B1|Baseline|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744094|NCT00003224|P6|Participant Flow|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744095|NCT00003224|P5|Participant Flow|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744096|NCT00003224|P4|Participant Flow|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744097|NCT00003224|P3|Participant Flow|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744098|NCT00003224|P2|Participant Flow|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744100|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744101|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744102|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744103|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744104|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744105|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744106|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744107|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744108|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744109|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744110|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
744111|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
744112|NCT00003224|O2|Outcome|All Montanide ISA-51|The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
744113|NCT00003224|O1|Outcome|All QS-21|The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
744114|NCT00003224|E2|Reported Event|Montanide ISA-51 Adjuvant|The combination of participants from Arms 2, 4, and 6, all treated with peptides plus Montanide ISA-51 adjuvant
744115|NCT00003224|E1|Reported Event|QS-21 Adjuvant|The combination of participants from Arms 1, 3, and 5, all treated with peptides plus QS-21 adjuvant
744116|NCT00089999|B3|Baseline|Total|Total of all reporting groups
744117|NCT00089999|B2|Baseline|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744118|NCT00089999|B1|Baseline|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744119|NCT00089999|P2|Participant Flow|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally twice daily (BID). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744120|NCT00089999|P1|Participant Flow|Lapatinib 1500 mg QD|Participants received lapatinib 1500 milligram (mg) orally once daily (QD). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744121|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744122|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744123|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744124|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744125|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744126|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744127|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744227|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
744128|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744129|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744130|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744131|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744132|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744133|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744134|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744135|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744136|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744137|NCT00089999|E2|Reported Event|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744138|NCT00089999|E1|Reported Event|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
744139|NCT00089986|B4|Baseline|Total|Total of all reporting groups
744140|NCT00089986|B3|Baseline|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
744141|NCT00089986|B2|Baseline|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
744142|NCT00089986|B1|Baseline|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
744143|NCT00089986|P3|Participant Flow|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
744177|NCT00089895|P2|Participant Flow|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744144|NCT00089986|P2|Participant Flow|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 milligrams per milliliter (mg/mL) lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 milligram (mg)/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
744145|NCT00089986|P1|Participant Flow|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, intravenously (IV) as a loading dose infused over 2 hours (h) followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 milliliters per kilogram per hour (mL/kg/h) for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
744146|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
744147|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
744148|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
744149|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
744150|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
744151|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
744152|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
744153|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
744154|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
744155|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
744156|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
744178|NCT00089895|P1|Participant Flow|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744157|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
744158|NCT00089986|E3|Reported Event|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
744159|NCT00089986|E2|Reported Event|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
744160|NCT00089986|E1|Reported Event|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
744161|NCT00089973|B1|Baseline|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744162|NCT00089973|P1|Participant Flow|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 milligram (mg)/ meter square (m^2). The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744163|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744164|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744165|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744166|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744167|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744168|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744169|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744170|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744171|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744172|NCT00089973|O1|Outcome|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744173|NCT00089973|E1|Reported Event|SB-715992|The eligible participants were administered Ispinesib, intravenously as a one-hour infusion on Day 1 of every 21-day treatment cycle, at a dose of 18 mg/m^2. The dosing was repeated for up to multiple cycles, until disease progression or removal from treatment due to an unacceptable toxicity or withdrawal of consent.
744174|NCT00089895|B3|Baseline|Total|Total of all reporting groups
744175|NCT00089895|B2|Baseline|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744176|NCT00089895|B1|Baseline|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744179|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744180|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744181|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744182|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744183|NCT00089895|E2|Reported Event|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744184|NCT00089895|E1|Reported Event|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
744185|NCT00089843|B5|Baseline|Total|Total of all reporting groups
744186|NCT00089843|B4|Baseline|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
744187|NCT00089843|B3|Baseline|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
744188|NCT00089843|B2|Baseline|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
744189|NCT00089843|B1|Baseline|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
744190|NCT00089843|P4|Participant Flow|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
744191|NCT00089843|P3|Participant Flow|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
744192|NCT00089843|P2|Participant Flow|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
744193|NCT00089843|P1|Participant Flow|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
744194|NCT00089843|O2|Outcome|Testosterone|Testosterone patch(starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
744195|NCT00089843|O1|Outcome|Actonel (Risedronate)|Actonel (risedronate) 35 mg tablet weekly
744196|NCT00089843|O2|Outcome|Testosterone|Testosterone, initial dose 150 mcg transdermal daily, increased to 300 mcg daily in women with free testosterone levels below the median (n=25 women)
744197|NCT00089843|O1|Outcome|Actonel (Risedronate) 35 mg Weekly|Actonel (risedronate) 35 mg, 1 tablet weekly
744198|NCT00089843|E4|Reported Event|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
744199|NCT00089843|E3|Reported Event|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
744200|NCT00089843|E2|Reported Event|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
744201|NCT00089843|E1|Reported Event|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
744202|NCT00089791|B3|Baseline|Total|Total of all reporting groups
744203|NCT00089791|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
744204|NCT00089791|B1|Baseline|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
744205|NCT00089791|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
744206|NCT00089791|P1|Participant Flow|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
744207|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
744208|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
744209|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
744210|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
744211|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
744212|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
744213|NCT00089791|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
744214|NCT00089791|E1|Reported Event|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
744215|NCT00089752|B3|Baseline|Total|Total of all reporting groups
744216|NCT00089752|B2|Baseline|Sham CPAP|Sham CPAP device
744217|NCT00089752|B1|Baseline|Active CPAP|CPAP device
744218|NCT00089752|P2|Participant Flow|Sham CPAP|A device that looks and sounds like an active continuous positive pressure device (CPAP) that delivers ineffective pressure, i.e.,less than 1 cm H20 pressure compared to greater than 5 cm H20 for active treatment. Like active CPAP treatment it is worn every night.
744219|NCT00089752|P1|Participant Flow|Active CPAP|Continuous positive pressure device that delivers therapeutic positive airway pressure to maintain airway patency worn continuously for each night of treatment.
744220|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
744221|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
744222|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
744223|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
744228|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
744229|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
744230|NCT00089752|O2|Outcome|Shame CPAP|Ineffective (placebo) Continuous Positive Airway Pressure device
744231|NCT00089752|O1|Outcome|CPAP|Active Continuous Positive Airway Pressure device
744232|NCT00089752|O2|Outcome|Sham CPAP|Sham CPAP device
744233|NCT00089752|O1|Outcome|Active CPAP|continuous positive airway pressure device
744234|NCT00089752|E2|Reported Event|Sham CPAP|A device worn continuously every night that looks and sounds like an active continuous positive pressure device (CPAP) that delivers ineffective pressure, i.e.,less than 1 cm H20 pressure for 8 wks.
744235|NCT00089752|E1|Reported Event|Active CPAP|Continuous positive pressure device that delivers therapeutic (prescribed > 5 CM H2O) positive airway pressure worn continuously for each night of treatment for 8 wks.
744236|NCT00089778|B4|Baseline|Total|Total of all reporting groups
744237|NCT00089778|B3|Baseline|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
744238|NCT00089778|B2|Baseline|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
744239|NCT00089778|B1|Baseline|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
744240|NCT00089778|P3|Participant Flow|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant).~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
744241|NCT00089778|P2|Participant Flow|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
744242|NCT00089778|P1|Participant Flow|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
744243|NCT00089778|O1|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
744244|NCT00089778|O3|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
744245|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
744246|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
744247|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
744302|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744303|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744304|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744305|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744248|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B)."
744249|NCT00089778|E3|Reported Event|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
744250|NCT00089778|E2|Reported Event|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
744251|NCT00089778|E1|Reported Event|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
744252|NCT00089674|B3|Baseline|Total|Total of all reporting groups
744253|NCT00089674|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744254|NCT00089674|B1|Baseline|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744255|NCT00089674|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744256|NCT00089674|P1|Participant Flow|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744257|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744258|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744259|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744260|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744261|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744262|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744263|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744264|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744265|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744266|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744267|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744268|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744269|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744270|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744271|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744272|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744273|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744274|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744275|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744276|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744277|NCT00089674|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
744278|NCT00089674|E1|Reported Event|Placebo|Placebo administered subcutaneous every 6 months for 3 years
744279|NCT00089661|B3|Baseline|Total|Total of all reporting groups
744280|NCT00089661|B2|Baseline|Placebo|
744281|NCT00089661|B1|Baseline|Denosumab 60 mg Q6M|
744282|NCT00089661|P2|Participant Flow|Placebo|
744283|NCT00089661|P1|Participant Flow|Denosumab 60 mg Q6M|
744284|NCT00089661|O2|Outcome|Placebo|
744285|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
744286|NCT00089661|O2|Outcome|Placebo|
744287|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
744288|NCT00089661|O2|Outcome|Placebo|
744289|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
744290|NCT00089661|O2|Outcome|Placebo|
744291|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
744292|NCT00089661|O2|Outcome|Placebo|
744293|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
744294|NCT00089661|O2|Outcome|Placebo|
744295|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
744296|NCT00089661|E2|Reported Event|Denosumab 60 mg Q6M|
744297|NCT00089661|E1|Reported Event|Placebo|
744298|NCT00089648|B1|Baseline|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744299|NCT00089648|P1|Participant Flow|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744300|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744301|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744717|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744306|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744307|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744308|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744309|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744310|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744311|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744312|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744313|NCT00089648|E1|Reported Event|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
744314|NCT00089635|B1|Baseline|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744315|NCT00089635|P1|Participant Flow|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744316|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744317|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744318|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744319|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744320|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744321|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744322|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744323|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744324|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744325|NCT00089635|E1|Reported Event|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
744326|NCT00089583|B3|Baseline|Total|Total of all reporting groups
744327|NCT00089583|B2|Baseline|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744328|NCT00089583|B1|Baseline|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744329|NCT00089583|P2|Participant Flow|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744330|NCT00089583|P1|Participant Flow|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744718|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744331|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744332|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744333|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744334|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744335|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744336|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744337|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744338|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
744339|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744340|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744341|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744342|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
744343|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744344|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744345|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744346|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
744347|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744348|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744349|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
744350|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
744351|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744529|NCT00089479|E1|Reported Event|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744530|NCT00089414|B4|Baseline|Total|Total of all reporting groups
744352|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744353|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744354|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744355|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744356|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744357|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744358|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744359|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744360|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744361|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744362|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744374|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744719|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744363|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744364|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744365|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744366|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744367|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744368|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744369|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744370|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744371|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744372|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744373|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744606|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744375|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744376|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744377|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744378|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744379|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744380|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744381|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744382|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744383|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744384|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744385|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744644|NCT00088907|E1|Reported Event|Step 1: Docetaxel+Placebo|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8,and 15 of a 28-day schedule~Placebo one tablet daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
744386|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744387|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744388|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744389|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744390|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744391|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744392|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744393|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744394|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744395|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744396|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744408|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744661|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
744662|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
744397|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744398|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744399|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744400|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744401|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744402|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744403|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744404|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744405|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744406|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744407|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744526|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744409|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744410|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744411|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744412|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744413|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744414|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744415|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744416|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744417|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744418|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744419|NCT00089583|E2|Reported Event|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
744527|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744663|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
744420|NCT00089583|E1|Reported Event|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
744421|NCT00089609|B3|Baseline|Total|Total of all reporting groups
744422|NCT00089609|B2|Baseline|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
744423|NCT00089609|B1|Baseline|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744424|NCT00089609|P2|Participant Flow|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
744425|NCT00089609|P1|Participant Flow|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744426|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744427|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744428|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744429|NCT00089609|O2|Outcome|Main Cohort - Particpants With <75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744430|NCT00089609|O1|Outcome|Main Cohort - Particpants With ≥75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744431|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744432|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744433|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744434|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744435|NCT00089609|O2|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
744436|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744437|NCT00089609|O1|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
744438|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744439|NCT00089609|E2|Reported Event|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
744440|NCT00089609|E1|Reported Event|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
744441|NCT00089544|B3|Baseline|Total|Total of all reporting groups
744442|NCT00089544|B2|Baseline|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
744664|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
744665|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
744443|NCT00089544|B1|Baseline|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
744444|NCT00089544|P2|Participant Flow|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
744445|NCT00089544|P1|Participant Flow|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
744446|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
744447|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
744448|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
744449|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
744450|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
744451|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
744452|NCT00089544|E2|Reported Event|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
744453|NCT00089544|E1|Reported Event|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
744454|NCT00089505|B5|Baseline|Total|Total of all reporting groups
744455|NCT00089505|B4|Baseline|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744456|NCT00089505|B3|Baseline|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744457|NCT00089505|B2|Baseline|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744458|NCT00089505|B1|Baseline|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744459|NCT00089505|P4|Participant Flow|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744460|NCT00089505|P3|Participant Flow|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744461|NCT00089505|P2|Participant Flow|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744462|NCT00089505|P1|Participant Flow|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744463|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744464|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744465|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744466|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744467|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744468|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744469|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744470|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744471|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744666|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
744472|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744473|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744474|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744475|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744476|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744477|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744478|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744479|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744480|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744481|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744482|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744483|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744484|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744485|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744528|NCT00089479|E2|Reported Event|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744486|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744487|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744488|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744489|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744490|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744491|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744492|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744493|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744494|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744495|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744496|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744497|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744498|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744499|NCT00089505|E4|Reported Event|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
744667|NCT00088634|E2|Reported Event|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
744500|NCT00089505|E3|Reported Event|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
744501|NCT00089505|E2|Reported Event|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
744502|NCT00089505|E1|Reported Event|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
744503|NCT00089479|B3|Baseline|Total|Total of all reporting groups
744504|NCT00089479|B2|Baseline|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744505|NCT00089479|B1|Baseline|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744506|NCT00089479|P2|Participant Flow|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744507|NCT00089479|P1|Participant Flow|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744508|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744509|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744510|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744511|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744512|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744513|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744514|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744515|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744516|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744517|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744518|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744519|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744520|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744521|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744522|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744523|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744524|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
744525|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
744668|NCT00088634|E1|Reported Event|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
744531|NCT00089414|B3|Baseline|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
744532|NCT00089414|B2|Baseline|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
744533|NCT00089414|B1|Baseline|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
744534|NCT00089414|P3|Participant Flow|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
744535|NCT00089414|P2|Participant Flow|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
744536|NCT00089414|P1|Participant Flow|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
744537|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
744538|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
744539|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
744540|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
744541|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
744542|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
744543|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
744544|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
744545|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
744641|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
744796|NCT00087685|E1|Reported Event|RAD001|10 mg orally daily/28-day cycles
744546|NCT00089414|E3|Reported Event|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
744547|NCT00089414|E2|Reported Event|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
744548|NCT00089414|E1|Reported Event|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
744549|NCT00089297|B1|Baseline|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
744550|NCT00089297|P1|Participant Flow|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
744551|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
744552|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
744553|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
744554|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
744642|NCT00088907|E3|Reported Event|Step 2: ZD1839|ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
744555|NCT00089297|E1|Reported Event|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
744556|NCT00089141|B3|Baseline|Total|Total of all reporting groups
744557|NCT00089141|B2|Baseline|Placebo|Patients receive oral placebo twice daily
744558|NCT00089141|B1|Baseline|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744559|NCT00089141|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily
744560|NCT00089141|P1|Participant Flow|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744561|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744562|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744563|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744564|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744565|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744566|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744567|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744568|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744569|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744570|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744571|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744572|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744573|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744574|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744575|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744576|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744577|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744578|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744579|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
744580|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
744581|NCT00089076|B1|Baseline|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744582|NCT00089076|P1|Participant Flow|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744583|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744584|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744585|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744586|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744587|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744588|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744589|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744590|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744591|NCT00089076|E1|Reported Event|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
744592|NCT00089011|B3|Baseline|Total|Total of all reporting groups
744643|NCT00088907|E2|Reported Event|Step 1: Docetaxel+ZD1839|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8, and 15 of a 28-day schedule.~ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
744593|NCT00089011|B2|Baseline|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744594|NCT00089011|B1|Baseline|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744595|NCT00089011|P2|Participant Flow|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744596|NCT00089011|P1|Participant Flow|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744597|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744598|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744599|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744600|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744601|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744602|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744603|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744604|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744605|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744797|NCT00087672|B1|Baseline|CC-5013|10 mg orally daily
744607|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744608|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744609|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744610|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744611|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744612|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744613|NCT00089011|E2|Reported Event|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
744614|NCT00089011|E1|Reported Event|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
744615|NCT00088985|B1|Baseline|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
744616|NCT00088985|P1|Participant Flow|Dendritic Cell Vaccine|"Dendritic Cells (DCs): Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250 μg/m2 sc each day for four days. G-CSF and/or GM-CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
744617|NCT00088985|O1|Outcome|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
744618|NCT00088985|O1|Outcome|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
744715|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744619|NCT00088985|E1|Reported Event|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
744620|NCT00088972|B3|Baseline|Total|Total of all reporting groups
744621|NCT00088972|B2|Baseline|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744622|NCT00088972|B1|Baseline|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744623|NCT00088972|P2|Participant Flow|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744624|NCT00088972|P1|Participant Flow|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744625|NCT00088972|O2|Outcome|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744626|NCT00088972|O1|Outcome|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744627|NCT00088972|O2|Outcome|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744628|NCT00088972|O1|Outcome|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744629|NCT00088972|E2|Reported Event|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744630|NCT00088972|E1|Reported Event|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
744631|NCT00088907|B3|Baseline|Total|Total of all reporting groups
744632|NCT00088907|B2|Baseline|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
744633|NCT00088907|B1|Baseline|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
744634|NCT00088907|P2|Participant Flow|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
744635|NCT00088907|P1|Participant Flow|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
744636|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
744637|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
744638|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
744639|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
744640|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
744716|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744798|NCT00087672|P1|Participant Flow|CC-5013|10 mg orally daily
744645|NCT00088881|B1|Baseline|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
744646|NCT00088881|P1|Participant Flow|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
744647|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
744648|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
744649|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
744650|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
744651|NCT00088881|E3|Reported Event|Step 3 - Radiation Therapy|Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
744652|NCT00088881|E2|Reported Event|Step 2 - Zevalin™ Radioimmunotherapy|Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
744653|NCT00088881|E1|Reported Event|Step 1 - R-CHOP|Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
744654|NCT00088634|B3|Baseline|Total|Total of all reporting groups
744655|NCT00088634|B2|Baseline|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
744656|NCT00088634|B1|Baseline|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
744657|NCT00088634|P2|Participant Flow|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
744658|NCT00088634|P1|Participant Flow|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
744659|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
744660|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
744669|NCT00088621|B1|Baseline|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
744670|NCT00088621|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.
744671|NCT00088621|O1|Outcome|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
744672|NCT00088621|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
744673|NCT00088595|B1|Baseline|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
744674|NCT00088595|P1|Participant Flow|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
744675|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
744676|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
744677|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
744678|NCT00088595|O3|Outcome|Pasireotide >1500-≤2400 μg|SOM230 (Pasireotide), more than 750µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
744679|NCT00088595|O2|Outcome|Pasireotide >900-≤1500 μg|SOM230 (Pasireotide), more than 450µg twice daily dose titration up to 750µg twice daily, subcutaneous injection.
744680|NCT00088595|O1|Outcome|Pasireotide 300-≤900 μg|SOM230 (Pasireotide), 150µg twice daily dose titration up to 450µg twice daily, subcutaneous injection.
744681|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 300 ug - 2400 ug / day
744682|NCT00088595|O3|Outcome|Pasireotide >1500 - ≤2400 μg|SOM230 (Pasireotide), >1500 - ≤2400 μg / day
744683|NCT00088595|O2|Outcome|Pasireotide >900 - ≤1500 μg|SOM230 (Pasireotide), >900 - ≤1500 μg / day
744684|NCT00088595|O1|Outcome|Pasireotide 300 - ≤900 μg|SOM230 (Pasireotide), 300 - ≤900 μg / day
744685|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
744686|NCT00088595|E3|Reported Event|Pasireotide > 1500 ≤ 2400 μg|Pasireotide > 1500 ≤ 2400 μg / day
744687|NCT00088595|E2|Reported Event|Pasireotide > 900 ≤ 1500 μg|Pasireotide > 900 ≤ 1500 μg / day
744688|NCT00088595|E1|Reported Event|Pasireotide 300 ≤ 900 μg|Pasireotide 300 ≤ 900 μg / day
744689|NCT00088530|B3|Baseline|Total|Total of all reporting groups
744690|NCT00088530|B2|Baseline|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
744691|NCT00088530|B1|Baseline|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
744692|NCT00088530|P2|Participant Flow|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
744693|NCT00088530|P1|Participant Flow|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle)
744694|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
744695|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
744696|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
744697|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
744698|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
744699|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
744700|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
744701|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
744702|NCT00088530|E2|Reported Event|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
744703|NCT00088530|E1|Reported Event|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
744704|NCT00088465|B1|Baseline|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744705|NCT00088465|P1|Participant Flow|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744706|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744707|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744708|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744709|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744710|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744711|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744712|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744713|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744714|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744720|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744721|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744722|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744723|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744724|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744725|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744726|NCT00088465|E1|Reported Event|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
744727|NCT00088374|B1|Baseline|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
744728|NCT00088374|P1|Participant Flow|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
744729|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
744730|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
744731|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
744732|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
744733|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
744734|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
744735|NCT00088374|E1|Reported Event|Participants With VHL Associated Renal Tumors|
744736|NCT00088218|B3|Baseline|Total|Total of all reporting groups
744737|NCT00088218|B2|Baseline|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
744738|NCT00088218|B1|Baseline|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
744739|NCT00088218|P2|Participant Flow|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
744740|NCT00088218|P1|Participant Flow|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
744741|NCT00088218|O2|Outcome|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
744742|NCT00088218|O1|Outcome|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
744743|NCT00088218|E2|Reported Event|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
744744|NCT00088218|E1|Reported Event|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
744745|NCT00088166|B3|Baseline|Total|Total of all reporting groups
744746|NCT00088166|B2|Baseline|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744747|NCT00088166|B1|Baseline|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744748|NCT00088166|P2|Participant Flow|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744749|NCT00088166|P1|Participant Flow|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744750|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744751|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744752|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744753|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744754|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744755|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744756|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744757|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744758|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744759|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744760|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744761|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744762|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744763|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744764|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744765|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744766|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744767|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744768|NCT00088166|E2|Reported Event|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
744769|NCT00088166|E1|Reported Event|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
744770|NCT00088153|B3|Baseline|Total|Total of all reporting groups
744799|NCT00087672|O1|Outcome|CC-5013|10 mg orally daily
744771|NCT00088153|B2|Baseline|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
744772|NCT00088153|B1|Baseline|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
744773|NCT00088153|P2|Participant Flow|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
744774|NCT00088153|P1|Participant Flow|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
744775|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
744776|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
744777|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
744778|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
744779|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
744780|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
744781|NCT00088153|E2|Reported Event|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
744782|NCT00088153|E1|Reported Event|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
744783|NCT00087698|B1|Baseline|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744784|NCT00087698|P1|Participant Flow|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744785|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744786|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744787|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744788|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744789|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744790|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
744791|NCT00087698|E1|Reported Event|Pemetrexed|pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 Gy
744792|NCT00087685|B1|Baseline|RAD001|10 mg orally daily/28-day cycles
744793|NCT00087685|P1|Participant Flow|RAD001|10 mg orally daily/28-day cycles
744794|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
744795|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
744802|NCT00087646|B4|Baseline|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744803|NCT00087646|B3|Baseline|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
744804|NCT00087646|B2|Baseline|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
744805|NCT00087646|B1|Baseline|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744806|NCT00087646|P4|Participant Flow|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744807|NCT00087646|P3|Participant Flow|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
744808|NCT00087646|P2|Participant Flow|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
744809|NCT00087646|P1|Participant Flow|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744810|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744811|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
744812|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
744813|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744814|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744815|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
744816|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
744817|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744818|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
744819|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
744820|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744821|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744822|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744823|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744824|NCT00087646|O2|Outcome|Group B + Group D|"Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
744825|NCT00087646|O1|Outcome|Group A + Group C|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks."
744826|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
744827|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
744828|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744829|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744830|NCT00087646|E4|Reported Event|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
744831|NCT00087646|E3|Reported Event|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
744832|NCT00087646|E2|Reported Event|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
744833|NCT00087646|E1|Reported Event|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
744834|NCT00087633|B3|Baseline|Total|Total of all reporting groups
744835|NCT00087633|B2|Baseline|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
744836|NCT00087633|B1|Baseline|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
744837|NCT00087633|P2|Participant Flow|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
744838|NCT00087633|P1|Participant Flow|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
744839|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
744840|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
744841|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
744842|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
744843|NCT00087633|E2|Reported Event|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
744844|NCT00087633|E1|Reported Event|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
744845|NCT00087607|B3|Baseline|Total|Total of all reporting groups
744846|NCT00087607|B2|Baseline|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744847|NCT00087607|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744848|NCT00087607|P2|Participant Flow|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b (12 kD) [PEG-Intron] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin [Rebetol] 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744849|NCT00087607|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a (40 kD) [Pegasys] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin [Copegus] 1000 or 1200 milligram (mg)/day), orally, [according to body weight, lesser than or greater than/equal to (< or >/=) 75 kilogram (kg), respectively] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744951|NCT00087555|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
745176|NCT00086411|P2|Participant Flow|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
744850|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744851|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744852|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744853|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744854|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744855|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744856|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744857|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744858|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744859|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744860|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744861|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744862|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744863|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744864|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744865|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744866|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744867|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744868|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744869|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744870|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744871|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744872|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744873|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744874|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744875|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744876|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744877|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744878|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744879|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744880|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744881|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744882|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744883|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744884|NCT00087607|E2|Reported Event|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744885|NCT00087607|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
744886|NCT00087594|B3|Baseline|Total|Total of all reporting groups
744887|NCT00087594|B2|Baseline|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744888|NCT00087594|B1|Baseline|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744889|NCT00087594|P2|Participant Flow|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744890|NCT00087594|P1|Participant Flow|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744891|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744892|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744893|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744894|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744895|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744896|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744897|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744898|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744899|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744952|NCT00087555|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
744953|NCT00087555|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
744900|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744901|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744902|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744903|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744904|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744905|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744906|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744907|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744908|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744909|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744910|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744911|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744912|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744913|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744914|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744915|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744916|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744917|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744918|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744954|NCT00087555|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
744919|NCT00087594|E2|Reported Event|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744920|NCT00087594|E1|Reported Event|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
744921|NCT00087568|B3|Baseline|Total|Total of all reporting groups
744922|NCT00087568|B2|Baseline|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744923|NCT00087568|B1|Baseline|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744924|NCT00087568|P2|Participant Flow|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744925|NCT00087568|P1|Participant Flow|Non-Responders|Participants received Pegasys 180 micrograms (µg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [mg/day (< or >=75 kg body weight, respectively)], orally in divided doses for 60 weeks.
744926|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744927|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744928|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744929|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744930|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744931|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744932|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744933|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744934|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744935|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744936|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744937|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744938|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744939|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744940|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744941|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744942|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744943|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744944|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744945|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744946|NCT00087568|E2|Reported Event|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
744947|NCT00087568|E1|Reported Event|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
744948|NCT00087555|B4|Baseline|Total|Total of all reporting groups
744949|NCT00087555|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
744950|NCT00087555|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
744955|NCT00087555|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
744956|NCT00087555|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
744957|NCT00087555|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
744958|NCT00087555|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
744959|NCT00087555|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
744960|NCT00087555|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
744961|NCT00087529|B3|Baseline|Total|Total of all reporting groups
744962|NCT00087529|B2|Baseline|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744963|NCT00087529|B1|Baseline|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744964|NCT00087529|P2|Participant Flow|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744965|NCT00087529|P1|Participant Flow|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744966|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744967|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744968|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744969|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744970|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744971|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744972|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744973|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744974|NCT00087529|E2|Reported Event|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744975|NCT00087529|E1|Reported Event|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
744976|NCT00087516|B4|Baseline|Total|Total of all reporting groups
744977|NCT00087516|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
744978|NCT00087516|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744979|NCT00087516|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744980|NCT00087516|P4|Participant Flow|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
745004|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744981|NCT00087516|P3|Participant Flow|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
744982|NCT00087516|P2|Participant Flow|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744983|NCT00087516|P1|Participant Flow|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744984|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
744985|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
744986|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744987|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744988|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
744989|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
744990|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744991|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744992|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
744993|NCT00087516|O3|Outcome|Placebo/ Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
744994|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744995|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744996|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
744997|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744998|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
744999|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
745000|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
745001|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
745002|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
745003|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
745005|NCT00087516|E4|Reported Event|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
745006|NCT00087516|E3|Reported Event|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
745007|NCT00087516|E2|Reported Event|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
745008|NCT00087516|E1|Reported Event|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
745009|NCT00087490|B3|Baseline|Total|Total of all reporting groups
745010|NCT00087490|B2|Baseline|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745011|NCT00087490|B1|Baseline|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745012|NCT00087490|P2|Participant Flow|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg per kilogram per dose (15 mg/kg/dose) over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745013|NCT00087490|P1|Participant Flow|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 milligram (mg). Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented methicillin-resistant Staphylococcus aureus (MRSA) bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745014|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745015|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745016|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745017|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745018|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745019|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745020|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745021|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745022|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745023|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745024|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745025|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745026|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745110|NCT00086684|E1|Reported Event|PLACEBO|
745027|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745028|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745029|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745030|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745031|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745032|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745033|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745034|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745035|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745036|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745037|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745038|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745039|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745040|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745041|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745042|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745043|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745044|NCT00087490|E2|Reported Event|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745045|NCT00087490|E1|Reported Event|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745046|NCT00087438|B1|Baseline|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
745047|NCT00087438|P1|Participant Flow|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
745048|NCT00087438|O1|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
745049|NCT00087438|E1|Reported Event|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
745111|NCT00086619|B3|Baseline|Total|Total of all reporting groups
745050|NCT00087152|B1|Baseline|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
745051|NCT00087152|P1|Participant Flow|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
745052|NCT00087152|O1|Outcome|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
745053|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
745054|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
745055|NCT00087152|E1|Reported Event|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
745056|NCT00087139|B4|Baseline|Total|Total of all reporting groups
745057|NCT00087139|B3|Baseline|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745058|NCT00087139|B2|Baseline|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745059|NCT00087139|B1|Baseline|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745060|NCT00087139|P3|Participant Flow|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745061|NCT00087139|P2|Participant Flow|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745062|NCT00087139|P1|Participant Flow|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745063|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745064|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745065|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745066|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745067|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745068|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745069|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745070|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745071|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745072|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745073|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745074|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
745075|NCT00087139|E1|Reported Event|Ixabepilone|All patients who received protocol therapy, regardless of eligibility, were evaluated for toxicities.
745076|NCT00086996|B1|Baseline|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
745077|NCT00086996|P1|Participant Flow|Chemo Plus RT, Surgery, Chemo|"Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and fluorouracil (5-FU) 180 mg/m^2/day infusion continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy at 180 centigray (cGy)/day, 5 days a week, for 5 weeks to a total dose of 4,500 cGy.~Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy. The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.~Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and 5-FU 180 mg/m^2/day by 24-hour infusion continuously on days 1-36."
745078|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
745079|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
745080|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
745081|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
745082|NCT00086996|E1|Reported Event|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
745083|NCT00086957|B1|Baseline|Dose Levels 1 & 2 - Docetaxel 60 & 75 mg/m^2|"trastuzumab: Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.~docetaxel: 75 mg/m^2 every three weeks, or 60 mg/m^2 every three weeks depending on study findings~gefitinib: 250 mg daily or 250 mg daily on days 2 through 14 depending on study findings"
745084|NCT00086957|P3|Participant Flow|Phase II - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
745085|NCT00086957|P2|Participant Flow|Phase I - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
745086|NCT00086957|P1|Participant Flow|Phase I - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
745087|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
745088|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
745089|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m2 intravenously every 3 weeks.
745090|NCT00086957|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
745091|NCT00086957|O2|Outcome|Phase I: Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
745092|NCT00086957|O1|Outcome|Phase I: Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
745093|NCT00086957|E2|Reported Event|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
745094|NCT00086957|E1|Reported Event|Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
745095|NCT00086684|B4|Baseline|Total|Total of all reporting groups
745096|NCT00086684|B3|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
745097|NCT00086684|B2|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
745098|NCT00086684|B1|Baseline|PLACEBO|
745099|NCT00086684|P3|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
745100|NCT00086684|P2|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
745101|NCT00086684|P1|Participant Flow|PLACEBO|
745102|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
745103|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
745104|NCT00086684|O1|Outcome|PLACEBO|
745105|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
745106|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
745107|NCT00086684|O1|Outcome|PLACEBO|
745108|NCT00086684|E3|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
745109|NCT00086684|E2|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
745112|NCT00086619|B2|Baseline|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
745113|NCT00086619|B1|Baseline|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
745114|NCT00086619|P2|Participant Flow|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
745115|NCT00086619|P1|Participant Flow|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
745116|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
745117|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
745118|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
745119|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
745120|NCT00086619|E2|Reported Event|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
745121|NCT00086619|E1|Reported Event|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
745122|NCT00086580|B3|Baseline|Total|Total of all reporting groups
745123|NCT00086580|B2|Baseline|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745124|NCT00086580|B1|Baseline|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745125|NCT00086580|P2|Participant Flow|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745126|NCT00086580|P1|Participant Flow|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745127|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745128|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745129|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745130|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745131|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745132|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745133|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745134|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745135|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745136|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745137|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745138|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745139|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745140|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745141|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745142|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745143|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745174|NCT00086411|P4|Participant Flow|4 Patch+Mayo|patch and Mayo counseling with placebo patch
745175|NCT00086411|P3|Participant Flow|3 Patch+MM|patch and MM with placebo pills
745144|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745145|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745146|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745147|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745148|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745149|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745150|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745151|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745152|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745153|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745154|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745155|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745156|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745157|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745158|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745159|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745160|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745161|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745162|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745163|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745164|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745165|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745166|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745167|NCT00086580|E2|Reported Event|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
745168|NCT00086580|E1|Reported Event|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
745169|NCT00086411|B5|Baseline|Total|Total of all reporting groups
745170|NCT00086411|B4|Baseline|4 Patch+Mayo|patch and Mayo counseling with placebo patch
745171|NCT00086411|B3|Baseline|3 Patch+MM|patch and MM with placebo pills
745172|NCT00086411|B2|Baseline|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
745173|NCT00086411|B1|Baseline|1: Bup+MM|bupropion and MM with placebo patch
745177|NCT00086411|P1|Participant Flow|1 Bup+MM|bupropion and MM with placebo patch
745178|NCT00086411|O4|Outcome|4 Patch+Mayo|patch and Mayo counseling with placebo patch
745179|NCT00086411|O3|Outcome|3 Patch+mm|patch and MM with placebo pills
745180|NCT00086411|O2|Outcome|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
745181|NCT00086411|O1|Outcome|1: Bup+MM|bupropion and MM with placebo patch
745182|NCT00086411|E4|Reported Event|4 Patch+Mayo|patch and Mayo counseling with placebo patch
745183|NCT00086411|E3|Reported Event|3 Patch+mm|patch and MM with placebo pills
745184|NCT00086411|E2|Reported Event|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
745185|NCT00086411|E1|Reported Event|1: Bup+MM|bupropion and MM with placebo patch
745186|NCT00086385|B5|Baseline|Total|Total of all reporting groups
745187|NCT00086385|B4|Baseline|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745188|NCT00086385|B3|Baseline|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745189|NCT00086385|B2|Baseline|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745190|NCT00086385|B1|Baseline|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745191|NCT00086385|P4|Participant Flow|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745192|NCT00086385|P3|Participant Flow|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745193|NCT00086385|P2|Participant Flow|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745194|NCT00086385|P1|Participant Flow|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745195|NCT00086385|O4|Outcome|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745196|NCT00086385|O3|Outcome|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745197|NCT00086385|O2|Outcome|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745198|NCT00086385|O1|Outcome|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745328|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745199|NCT00086385|E4|Reported Event|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745200|NCT00086385|E3|Reported Event|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745201|NCT00086385|E2|Reported Event|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745202|NCT00086385|E1|Reported Event|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
745203|NCT00086515|B3|Baseline|Total|Total of all reporting groups
745204|NCT00086515|B2|Baseline|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
745205|NCT00086515|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
745206|NCT00086515|P2|Participant Flow|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
745207|NCT00086515|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
745208|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
745209|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
745210|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
745211|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
745212|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
745213|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
745214|NCT00086515|E2|Reported Event|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
745215|NCT00086515|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
745216|NCT00086502|B3|Baseline|Total|Total of all reporting groups
745217|NCT00086502|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745218|NCT00086502|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745219|NCT00086502|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745220|NCT00086502|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745221|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745222|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745223|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745224|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745225|NCT00086502|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745226|NCT00086502|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
745227|NCT00086450|B3|Baseline|Total|Total of all reporting groups
745228|NCT00086450|B2|Baseline|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
745229|NCT00086450|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
745230|NCT00086450|P2|Participant Flow|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
745231|NCT00086450|P1|Participant Flow|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
745232|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
745233|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
745234|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
745235|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
745236|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
745237|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
745238|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
745239|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
745240|NCT00086450|E2|Reported Event|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
745241|NCT00086450|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
745242|NCT00086346|B3|Baseline|Total|Total of all reporting groups
745243|NCT00086346|B2|Baseline|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
745244|NCT00086346|B1|Baseline|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
745245|NCT00086346|P2|Participant Flow|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
745246|NCT00086346|P1|Participant Flow|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
745334|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745247|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
745248|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
745249|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
745250|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
745251|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
745252|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
745253|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
745254|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
745255|NCT00086346|E2|Reported Event|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
745256|NCT00086346|E1|Reported Event|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
745257|NCT00086281|B16|Baseline|Total|Total of all reporting groups
745258|NCT00086281|B15|Baseline|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745259|NCT00086281|B14|Baseline|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
745260|NCT00086281|B13|Baseline|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
745261|NCT00086281|B12|Baseline|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
745262|NCT00086281|B11|Baseline|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745263|NCT00086281|B10|Baseline|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745264|NCT00086281|B9|Baseline|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745265|NCT00086281|B8|Baseline|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745329|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745330|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745266|NCT00086281|B7|Baseline|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745267|NCT00086281|B6|Baseline|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
745268|NCT00086281|B5|Baseline|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745269|NCT00086281|B4|Baseline|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
745270|NCT00086281|B3|Baseline|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
745271|NCT00086281|B2|Baseline|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745272|NCT00086281|B1|Baseline|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745273|NCT00086281|P15|Participant Flow|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745274|NCT00086281|P14|Participant Flow|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
745275|NCT00086281|P13|Participant Flow|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
745276|NCT00086281|P12|Participant Flow|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
745277|NCT00086281|P11|Participant Flow|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745278|NCT00086281|P10|Participant Flow|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745279|NCT00086281|P9|Participant Flow|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745280|NCT00086281|P8|Participant Flow|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745281|NCT00086281|P7|Participant Flow|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745282|NCT00086281|P6|Participant Flow|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
745331|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745332|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745333|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745283|NCT00086281|P5|Participant Flow|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745284|NCT00086281|P4|Participant Flow|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
745285|NCT00086281|P3|Participant Flow|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
745286|NCT00086281|P2|Participant Flow|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
745287|NCT00086281|P1|Participant Flow|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
745288|NCT00086281|O4|Outcome|Zolpidem + Placebo|Zolpidem + Placebo
745289|NCT00086281|O3|Outcome|Xyrem + Modafinil|Xyrem + Modafinil
745290|NCT00086281|O2|Outcome|Xyrem|Xyrem
745291|NCT00086281|O1|Outcome|Placebo|Placebo
745292|NCT00086281|E4|Reported Event|Z + P|Zolpidem + Placebo
745293|NCT00086281|E3|Reported Event|X + M|Xyrem + Modafinil
745294|NCT00086281|E2|Reported Event|Xyrem|Xyrem
745295|NCT00086281|E1|Reported Event|Placebo|Placebo
745296|NCT00086307|B4|Baseline|Total|Total of all reporting groups
745297|NCT00086307|B3|Baseline|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
745298|NCT00086307|B2|Baseline|Escitalopram|Patients receive escitalopram and placebo.
745299|NCT00086307|B1|Baseline|Pramipexole|Patients receive pramipexole and placebo.
745300|NCT00086307|P3|Participant Flow|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
745301|NCT00086307|P2|Participant Flow|Escitalopram|Patients receive escitalopram and placebo.
745302|NCT00086307|P1|Participant Flow|Pramipexole|Patients receive pramipexole and placebo.
745303|NCT00086307|O3|Outcome|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
745304|NCT00086307|O2|Outcome|Escitalopram|Patients receive escitalopram and placebo.
745305|NCT00086307|O1|Outcome|Pramipexole|Patients receive pramipexole and placebo.
745306|NCT00086307|E3|Reported Event|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
745307|NCT00086307|E2|Reported Event|Escitalopram|Patients receive escitalopram and placebo.
745308|NCT00086307|E1|Reported Event|Pramipexole|Patients receive pramipexole and placebo.
745309|NCT00086190|B4|Baseline|Total|Total of all reporting groups
745310|NCT00086190|B3|Baseline|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
745311|NCT00086190|B2|Baseline|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
745312|NCT00086190|B1|Baseline|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
745313|NCT00086190|P3|Participant Flow|Placebo|Placebo was made to match treatment options.
745314|NCT00086190|P2|Participant Flow|Venlafaxine Extended Release|Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
745315|NCT00086190|P1|Participant Flow|Paroxetine|Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
745316|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745317|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745318|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745319|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745320|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745321|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745322|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745323|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745324|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745325|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745326|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745327|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745335|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745336|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745337|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745338|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745339|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745340|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745341|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745342|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745343|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745344|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745345|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745346|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745347|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745348|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745349|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745350|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745351|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745352|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745353|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745354|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745355|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745356|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745357|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745358|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745359|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745360|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745361|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745362|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745363|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745364|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
745365|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
745366|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
745367|NCT00086190|E3|Reported Event|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
745368|NCT00086190|E2|Reported Event|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
745369|NCT00086190|E1|Reported Event|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
745370|NCT00086138|B3|Baseline|Total|Total of all reporting groups
745371|NCT00086138|B2|Baseline|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
745372|NCT00086138|B1|Baseline|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
745373|NCT00086138|P2|Participant Flow|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
745374|NCT00086138|P1|Participant Flow|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
745375|NCT00086138|O2|Outcome|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
745376|NCT00086138|O1|Outcome|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
745377|NCT00086138|O2|Outcome|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
745378|NCT00086138|O1|Outcome|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
745379|NCT00086138|E2|Reported Event|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
745380|NCT00086138|E1|Reported Event|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
745381|NCT00086047|B3|Baseline|Total|Total of all reporting groups
745382|NCT00086047|B2|Baseline|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
745383|NCT00086047|B1|Baseline|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
745384|NCT00086047|P2|Participant Flow|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
745385|NCT00086047|P1|Participant Flow|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
745386|NCT00086047|O2|Outcome|Fibromyalgia Education|Consists of education about fibromyalgia and its management
745387|NCT00086047|O1|Outcome|Coping Skills Training|Consists of training in pain management skills using cognitive-behavioral therapy techniques
745388|NCT00086047|E2|Reported Event|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
745389|NCT00086047|E1|Reported Event|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
745390|NCT00085917|B3|Baseline|Total|Total of all reporting groups
745391|NCT00085917|B2|Baseline|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
745392|NCT00085917|B1|Baseline|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
745393|NCT00085917|P2|Participant Flow|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
745394|NCT00085917|P1|Participant Flow|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
745395|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
745396|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
745397|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
745398|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
745399|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
745400|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
745401|NCT00085917|E2|Reported Event|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
745402|NCT00085917|E1|Reported Event|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
745403|NCT00085839|B3|Baseline|Total|Total of all reporting groups
745404|NCT00085839|B2|Baseline|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
745405|NCT00085839|B1|Baseline|Erlotinib|Erlotinib 150 mg/day continuous therapy
745406|NCT00085839|P2|Participant Flow|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
745407|NCT00085839|P1|Participant Flow|Erlotinib|Erlotinib 150 mg/day continuous therapy
745408|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
745409|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
745410|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
745411|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
745412|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
745413|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
745414|NCT00085839|E2|Reported Event|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
745415|NCT00085839|E1|Reported Event|Erlotinib|Erlotinib 150 mg/day continuous therapy
745416|NCT00085735|B7|Baseline|Total|Total of all reporting groups
745417|NCT00085735|B6|Baseline|Arm VI (8-21 Years of Age, SDCSI, PFRT)|Eligible patients 8-21 yrs of age, SDCSI, PFRT
745418|NCT00085735|B5|Baseline|Arm V (8-21 Years of Age, SDCSI, IFRT)|Eligible patients 8-21 yrs of age, SDCSI, IFRT
745419|NCT00085735|B4|Baseline|Arm IV (3-7 Years of Age, SDCSI, PFRT)|Eligible patients 3-7 yrs of age, SDCSI, PFRT
745420|NCT00085735|B3|Baseline|Arm III (3-7 Years of Age, SDCSI, IFRT)|Eligible patients 3-7 yrs of age, SDCSI, IFRT
745421|NCT00085735|B2|Baseline|Arm II (3-7 Years of Age, LDCSI, PFRT)|Eligible patients 3-7 yrs of age, LDCSI, PFRT
745422|NCT00085735|B1|Baseline|Arm I (3-7 Years of Age, LDCSI, IFRT)|Eligible patients 3-7 yrs of age, LDCSI, IFRT
745423|NCT00085735|P6|Participant Flow|Arm VI (8-21 Yrs of Age, SDCSI, PFRT)|Patients 8-21 yrs of age, SDCSI, PFRT
745424|NCT00085735|P5|Participant Flow|Arm V (8-21 Yrs of Age, SDCSI, IFRT)|Patients 8-21 years of age, SDCSI, IFRT
745425|NCT00085735|P4|Participant Flow|Arm IV (3-7 Yrs of Age, SDCSI, PFRT)|Patients 3-7 years of age, SDCSI, PFRT
745426|NCT00085735|P3|Participant Flow|Arm III (3-7 Yrs of Age, SDCSI, IFRT)|Patients 3-7 years of age, SDCSI, IFRT
745427|NCT00085735|P2|Participant Flow|Arm II (3-7 Yrs of Age, LDCSI, PFRT)|Patients 3-7 years of age, LDCSI, PFRT
745428|NCT00085735|P1|Participant Flow|Arm I (3-7 Yrs of Age, LDCSI, IFRT)|Patients 3-7 years of age, LDCSI, IFRT
745429|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
745430|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
745431|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
745432|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
745433|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
745434|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
745435|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
745436|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
745437|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
745438|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
745439|NCT00085735|O4|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
745440|NCT00085735|O3|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
745441|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
745442|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
745443|NCT00085735|O4|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
745444|NCT00085735|O3|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
745445|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
745446|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
745447|NCT00085735|E6|Reported Event|Arm VI (8-21 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm VI)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
745448|NCT00085735|E5|Reported Event|Arm V (8-21 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm V)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
745449|NCT00085735|E4|Reported Event|Arm IV (3-7 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm IV)~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
745450|NCT00085735|E3|Reported Event|Arm III (3-7 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm III)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
745451|NCT00085735|E2|Reported Event|Arm II (3-7 Years of Age, LDCSI, PFRT)|"See Detailed Description (Arm II)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
745452|NCT00085735|E1|Reported Event|Arm I (3-7 Years of Age, LDCSI, IFRT)|"See Detailed Description (Arm I)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
745453|NCT00085709|B3|Baseline|Total|Total of all reporting groups
745454|NCT00085709|B2|Baseline|ARA-C+Daunomycin|ARA-C+Daunomycin
745455|NCT00085709|B1|Baseline|Ara-C+Daunomycin+Mylotarg|Ara-C+Daunomycin+Mylotarg
745456|NCT00085709|P2|Participant Flow|ARA-C+Daunomycin|Standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
745457|NCT00085709|P1|Participant Flow|Ara-C+Daunomycin+Mylotarg|Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
745458|NCT00085709|O4|Outcome|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
745459|NCT00085709|O3|Outcome|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
745460|NCT00085709|O2|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
745461|NCT00085709|O1|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
745462|NCT00085709|O2|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
745463|NCT00085709|O1|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
745464|NCT00085709|O2|Outcome|Post-consolidation Observation|Patients did not receive any post-consolidation therapy
745465|NCT00085709|O1|Outcome|Post-consolidation GO|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
745466|NCT00085709|E4|Reported Event|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
745467|NCT00085709|E3|Reported Event|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
745468|NCT00085709|E2|Reported Event|Induction 7 + 3|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
745469|NCT00085709|E1|Reported Event|Induction 7 + 3 + G.O.|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
745470|NCT00085644|B3|Baseline|Total|Total of all reporting groups
745471|NCT00085644|B2|Baseline|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
745472|NCT00085644|B1|Baseline|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
745473|NCT00085644|P3|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
745474|NCT00085644|P2|Participant Flow|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
745475|NCT00085644|P1|Participant Flow|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
745476|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745477|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745478|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745479|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745480|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745481|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745482|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745483|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745484|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745485|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745486|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745487|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745488|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745489|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745490|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745491|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745492|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745493|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745494|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745495|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745496|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745497|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745498|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745499|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745500|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745501|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745502|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745503|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745504|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745505|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745506|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745507|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745508|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745509|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745510|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
745511|NCT00085644|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
745512|NCT00085644|O2|Outcome|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
745513|NCT00085644|O1|Outcome|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
745514|NCT00085644|E1|Reported Event|Any Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
745515|NCT00085631|B1|Baseline|Overall Study|Due to integrity issues with the current data, baseline measurements of age and gender are reported for the entire cohort, rather than by treatment arm. Age and gender information were available in the current documentation for all 101 patients in this study.
745516|NCT00085631|P3|Participant Flow|Chemoradiation + Hyperthermia|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, together with hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
745517|NCT00085631|P2|Participant Flow|Chemoradiation|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, without hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
745518|NCT00085631|P1|Participant Flow|Unavailable|"Unavailable refers to patients who were randomized into one of the two treatment groups, but whose assignment could not be deduced from the current data. Completed patients were those who had documented response or follow-up data in the current dataset."
745519|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year overall survival rate in this study.
745520|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year local recurrence-free survival rate in this study.
745521|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year failure-free survival rate in this study.
745522|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the primary tumor response rate in this study.
745523|NCT00085631|E1|Reported Event|Overall Study|Patients from both arms were combined in adverse event reporting.
745524|NCT00085566|B4|Baseline|Total|Total of all reporting groups
745525|NCT00085566|B3|Baseline|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745526|NCT00085566|B2|Baseline|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745527|NCT00085566|B1|Baseline|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745528|NCT00085566|P3|Participant Flow|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745529|NCT00085566|P2|Participant Flow|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745530|NCT00085566|P1|Participant Flow|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745531|NCT00085566|O3|Outcome|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745532|NCT00085566|O2|Outcome|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745533|NCT00085566|O1|Outcome|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745534|NCT00085566|E3|Reported Event|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745535|NCT00085566|E2|Reported Event|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745536|NCT00085566|E1|Reported Event|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
745537|NCT00085540|B3|Baseline|Total|Total of all reporting groups
745538|NCT00085540|B2|Baseline|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
745570|NCT00085410|E1|Reported Event|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745539|NCT00085540|B1|Baseline|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
745540|NCT00085540|P2|Participant Flow|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
745541|NCT00085540|P1|Participant Flow|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
745542|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
745543|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
745544|NCT00085540|O1|Outcome|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
745545|NCT00085540|E2|Reported Event|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
745546|NCT00085540|E1|Reported Event|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
745547|NCT00085436|B1|Baseline|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
745548|NCT00085436|P1|Participant Flow|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
745549|NCT00085436|O1|Outcome|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
745550|NCT00085436|E1|Reported Event|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
745551|NCT00085423|B1|Baseline|Lymphodepleting Chemotherapy + High Dose IL-2|intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). GM-CSF (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
745552|NCT00085423|P1|Participant Flow|Lymphodepleting Chemotherapy + High Dose Interleukin-2|"Lymphodepleting chemotherapy + high dose interleukin-2:~Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery."
745553|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
745554|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
745555|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
745556|NCT00085423|E1|Reported Event|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
745557|NCT00085410|B1|Baseline|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745558|NCT00085410|P1|Participant Flow|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745559|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745560|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745561|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745562|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745563|NCT00085410|O1|Outcome|Arm I|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.~bortezomib: Given IV"
745564|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745565|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745566|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745567|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745568|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745569|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
745571|NCT00085293|B1|Baseline|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
745572|NCT00085293|P1|Participant Flow|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
745573|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
745574|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
745575|NCT00085293|E1|Reported Event|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
745576|NCT00085254|B4|Baseline|Total|Total of all reporting groups
745577|NCT00085254|B3|Baseline|Arm 3 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745578|NCT00085254|B2|Baseline|Arm 2 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745579|NCT00085254|B1|Baseline|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745580|NCT00085254|P3|Participant Flow|Arm 3 - Phase II (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (2000mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide,Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
746277|NCT00081458|O1|Outcome|Placebo|Placebo injected subcutaneously daily into the thigh or abdomen
745581|NCT00085254|P2|Participant Flow|Arm 2 - Phase II (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (500mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide, Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745582|NCT00085254|P1|Participant Flow|Arm 1 (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745583|NCT00085254|O1|Outcome|Arm 4 (Overall Study)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745584|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (2000mg)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745585|NCT00085254|O1|Outcome|Arm 1- Phase 2 (500mg)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745586|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745587|NCT00085254|O1|Outcome|Arm 1 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745588|NCT00085254|O1|Outcome|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745589|NCT00085254|O3|Outcome|Arm 3 2000mg (Safety Run-In)|"INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
745590|NCT00085254|O2|Outcome|ARM 2 1000mg (Safety run-in)|"INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 1000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
745591|NCT00085254|O1|Outcome|Arm 1 500mg (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 500mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
745592|NCT00085254|E3|Reported Event|Dose 2000|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745593|NCT00085254|E2|Reported Event|Dose 1000|"INITIATION COURSE: Patients receive cilengitide (1000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745594|NCT00085254|E1|Reported Event|Dose 500|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
745595|NCT00085202|B3|Baseline|Total|Total of all reporting groups
745596|NCT00085202|B2|Baseline|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
745597|NCT00085202|B1|Baseline|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
745598|NCT00085202|P2|Participant Flow|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
745599|NCT00085202|P1|Participant Flow|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
745600|NCT00085202|O8|Outcome|WNT Pathway - SNV Germline|Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV).
745601|NCT00085202|O7|Outcome|SHH Pathway - SNV Germline|Tissue from this subgroup of patients was analyzed for germline single nucleotide variation (SNV).
745602|NCT00085202|O6|Outcome|WNT Pathway - SNV Somatic|Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV).
745603|NCT00085202|O5|Outcome|SHH Pathway - SNV Somatic|Tissue from this subgroup of patients was analyzed for somatic single nucleotide variation (SNV).
745604|NCT00085202|O4|Outcome|WNT Pathway - In/Del Germline|Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).
745605|NCT00085202|O3|Outcome|SHH Pathway - In/Del Germline|Tissue from this subgroup of patients was analyzed for germline insertion/deletion (In/Del).
745606|NCT00085202|O2|Outcome|WNT Pathway - In/Del Somatic|Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).
745607|NCT00085202|O1|Outcome|SHH Pathway - In/Del Somatic|Tissue from this subgroup of patients was analyzed for somatic insertion/deletion (In/Del).
745608|NCT00085202|O4|Outcome|ERBB2 Negative & High Risk|14 participants who were ERBB2 negative and in the high risk group
745609|NCT00085202|O3|Outcome|ERBB2 Negative & Average Risk|31 participants who were ERBB2 negative and in the average risk group
745610|NCT00085202|O2|Outcome|ERBB2 Positive & High Risk|23 participants who were ERBB2 positive and in the high risk group
745611|NCT00085202|O1|Outcome|ERBB2 Positive & Average Risk|54 participants who were ERBB2 positive and in the average risk group.
745612|NCT00085202|O3|Outcome|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
745613|NCT00085202|O2|Outcome|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
745614|NCT00085202|O1|Outcome|Overall Study|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
745615|NCT00085202|E2|Reported Event|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
745616|NCT00085202|E1|Reported Event|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
745617|NCT00085098|B3|Baseline|Total|Total of all reporting groups
745618|NCT00085098|B2|Baseline|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
745619|NCT00085098|B1|Baseline|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
745620|NCT00085098|P2|Participant Flow|Regimen B (Chemotherapy Plus Radiotherapy)|Courses 1,2:Patients (PTS) receive carboplatin IV over 1 hour on days 1-2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Within 3 weeks of completing chemotherapy, PTS with complete response (CR) undergo low-dose radiation therapy 5 days a week for 5 weeks. PTS with minimal residual disease (MRD), a PR, or stable disease (SD) receive chemotherapy courses 3,4. Courses 3,4:PTS receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2-3 and filgrastim (G-CSF) subcutaneous (SC) or IV on day 4 continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. PTS achieving a CR or MRD proceed to reduced-dose radiotherapy. PTS with a partial response (PR), SD or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A.Reduced-dose radiation therapy: Within 6 weeks of starting course 4, PTS undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks.
745621|NCT00085098|P1|Participant Flow|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
745622|NCT00085098|O2|Outcome|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
745623|NCT00085098|O1|Outcome|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
745624|NCT00085098|E2|Reported Event|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
745625|NCT00085098|E1|Reported Event|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
745626|NCT00084864|B5|Baseline|Total|Total of all reporting groups
745627|NCT00084864|B4|Baseline|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745628|NCT00084864|B3|Baseline|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745629|NCT00084864|B2|Baseline|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745630|NCT00084864|B1|Baseline|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745631|NCT00084864|P4|Participant Flow|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745632|NCT00084864|P3|Participant Flow|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745633|NCT00084864|P2|Participant Flow|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745634|NCT00084864|P1|Participant Flow|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745635|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745636|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745637|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745638|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745639|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745640|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745641|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745642|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745643|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745644|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745645|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745646|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745647|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745648|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745649|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745650|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745651|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745652|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745653|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745654|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745655|NCT00084864|E4|Reported Event|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
745656|NCT00084864|E3|Reported Event|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
745657|NCT00084864|E2|Reported Event|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
745658|NCT00084864|E1|Reported Event|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
745659|NCT00084838|B1|Baseline|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
745660|NCT00084838|P1|Participant Flow|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
745687|NCT00084682|P1|Participant Flow|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
745661|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745662|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745663|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745664|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745665|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745666|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745667|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745688|NCT00084682|O1|Outcome|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
745668|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745669|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745670|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745671|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745672|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745673|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745674|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745689|NCT00084682|E1|Reported Event|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
745675|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745676|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
745677|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
745678|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
745679|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
745680|NCT00084838|E1|Reported Event|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
745681|NCT00084747|B1|Baseline|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
745682|NCT00084747|P1|Participant Flow|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
745683|NCT00084747|O1|Outcome|Bortezomib|bortezomib
745684|NCT00084747|O1|Outcome|Bortezomib|autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
745685|NCT00084747|E1|Reported Event|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
745686|NCT00084682|B1|Baseline|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
745720|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745690|NCT00084617|B1|Baseline|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
745691|NCT00084617|P1|Participant Flow|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
745692|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
745693|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
745694|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
745695|NCT00084617|E1|Reported Event|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
745696|NCT00084487|B1|Baseline|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745697|NCT00084487|P1|Participant Flow|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745698|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745699|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745700|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745701|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745702|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745703|NCT00084487|E1|Reported Event|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
745704|NCT00084409|B3|Baseline|Total|Total of all reporting groups
745705|NCT00084409|B2|Baseline|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745706|NCT00084409|B1|Baseline|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745707|NCT00084409|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745708|NCT00084409|P1|Participant Flow|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745709|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745710|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745711|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745712|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745713|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745714|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745715|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745716|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745717|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745718|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745719|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745721|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745722|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745723|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745724|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745725|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745726|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745727|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745728|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745729|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745730|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745731|NCT00084409|O2|Outcome|Placebo|
745732|NCT00084409|O1|Outcome|Iloprost|
745733|NCT00084409|E2|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745734|NCT00084409|E1|Reported Event|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
745735|NCT00084383|B1|Baseline|GVAX Pancreatic Cancer Vaccine|
745736|NCT00084383|P1|Participant Flow|GVAX Pancreatic Cancer Vaccine|
745737|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
745738|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
745739|NCT00084383|E1|Reported Event|GVAX Pancreatic Cancer Vaccine|
745740|NCT00084318|B3|Baseline|Total|Total of all reporting groups
745741|NCT00084318|B2|Baseline|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745742|NCT00084318|B1|Baseline|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745743|NCT00084318|P2|Participant Flow|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745744|NCT00084318|P1|Participant Flow|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745745|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745746|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745747|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745748|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745749|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745750|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745751|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745752|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745753|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745754|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745755|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745756|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745757|NCT00084318|E2|Reported Event|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
745758|NCT00084318|E1|Reported Event|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
745759|NCT00084266|B3|Baseline|Total|Total of all reporting groups
745760|NCT00084266|B2|Baseline|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745761|NCT00084266|B1|Baseline|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745762|NCT00084266|P2|Participant Flow|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745763|NCT00084266|P1|Participant Flow|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745764|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745765|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745766|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745767|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745768|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745769|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745770|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745771|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745772|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745773|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745774|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745775|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745776|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745777|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745778|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745779|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745780|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745781|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745782|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745783|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745784|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745785|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745819|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745786|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745787|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745788|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745789|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745790|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745791|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745792|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745793|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745794|NCT00084266|E2|Reported Event|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745795|NCT00084266|E1|Reported Event|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
745796|NCT00084136|B4|Baseline|Total|Total of all reporting groups
745797|NCT00084136|B3|Baseline|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745798|NCT00084136|B2|Baseline|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
745799|NCT00084136|B1|Baseline|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745800|NCT00084136|P3|Participant Flow|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745801|NCT00084136|P2|Participant Flow|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
745802|NCT00084136|P1|Participant Flow|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745803|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745804|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745805|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745806|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745807|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745808|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745809|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745810|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745811|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745812|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745813|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745814|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745815|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745816|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745817|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745818|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745820|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745821|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745822|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745823|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745824|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745825|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745826|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745827|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745828|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745829|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745830|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745831|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745832|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745833|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745834|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745835|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745836|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745837|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
745838|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745839|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745840|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745841|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745842|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745843|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
745844|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745845|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745846|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745847|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745848|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745849|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745850|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745851|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745852|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745853|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745854|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
745855|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
745856|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
745857|NCT00084136|E3|Reported Event|TDF/FTC+EFV|
745858|NCT00084136|E2|Reported Event|ddI+FTC+ATV|
745859|NCT00084136|E1|Reported Event|ZDV/3TC+EFV|
745860|NCT00084084|B1|Baseline|Agalsidase Alfa (Cohort 1)|0.2 mg/kg agalsidase alfa infused by IV over 40 (+/- 10) minutes every other week
745861|NCT00084084|P1|Participant Flow|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
745862|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
745863|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
745864|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
745993|NCT00082758|B4|Baseline|Total|Total of all reporting groups
745865|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
745866|NCT00084084|E2|Reported Event|Transition Safety Population|A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2.
745867|NCT00084084|E1|Reported Event|Safety Population RB|Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included.
745868|NCT00083915|B3|Baseline|Total|Total of all reporting groups
745869|NCT00083915|B2|Baseline|Mel-DT PACE|
745870|NCT00083915|B1|Baseline|High Dose Melphalan|
745871|NCT00083915|P2|Participant Flow|Mel-DT PACE|
745872|NCT00083915|P1|Participant Flow|High Dose Melphalan|
745873|NCT00083915|O2|Outcome|Mel-DT PACE|
745874|NCT00083915|O1|Outcome|High Dose Melphalan|
745875|NCT00083915|E2|Reported Event|Mel-DT PACE|
745876|NCT00083915|E1|Reported Event|High Dose Melphalan|
745877|NCT00083889|B3|Baseline|Total|Total of all reporting groups
745878|NCT00083889|B2|Baseline|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745879|NCT00083889|B1|Baseline|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745880|NCT00083889|P2|Participant Flow|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745881|NCT00083889|P1|Participant Flow|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745882|NCT00083889|O1|Outcome|Total Drug: SU011248 and SU012662|SU011248 and active metabolite SU012662
745883|NCT00083889|O1|Outcome|SU012662|Active metabolite of SU011248
745884|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle. Intra-subject dose reduction to 35.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745885|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745886|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745887|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745888|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745889|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745890|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745891|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745892|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745893|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745894|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745895|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745896|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745897|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745898|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745899|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745900|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745901|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745902|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745903|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745904|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745905|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745906|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745907|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745908|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745909|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745910|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745911|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745912|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745913|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745914|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745915|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745916|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745917|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745918|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745919|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745920|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745921|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745922|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745923|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745924|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745925|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745926|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
746053|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
745927|NCT00083889|E2|Reported Event|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
745928|NCT00083889|E1|Reported Event|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
745929|NCT00004146|B1|Baseline|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
745930|NCT00004146|P1|Participant Flow|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
745931|NCT00004146|O2|Outcome|CAI With RT Without Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
745932|NCT00004146|O1|Outcome|CAI With RT + Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
745933|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
745934|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
745935|NCT00004146|E1|Reported Event|Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
745936|NCT00083759|B3|Baseline|Total|Total of all reporting groups
745937|NCT00083759|B2|Baseline|Placebo|Placebo IV infusions + methotrexate (MTX)
745938|NCT00083759|B1|Baseline|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
745939|NCT00083759|P2|Participant Flow|Placebo|Placebo IV infusions + methotrexate (MTX)
745940|NCT00083759|P1|Participant Flow|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
745941|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
745942|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
745943|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
745944|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
745945|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
745946|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
745947|NCT00083720|B1|Baseline|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745948|NCT00083720|P1|Participant Flow|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745949|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745950|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745951|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745952|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745953|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745954|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745955|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745956|NCT00083720|E1|Reported Event|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
745957|NCT00083616|B1|Baseline|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745958|NCT00083616|P1|Participant Flow|Panitumumab (ABX-EGF)|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745959|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745960|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745961|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745962|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745963|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
746278|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
745964|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745965|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745966|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745967|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
745968|NCT00083616|E1|Reported Event|Panitumumab|
745969|NCT00083551|B3|Baseline|Total|Total of all reporting groups
745970|NCT00083551|B2|Baseline|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
745971|NCT00083551|B1|Baseline|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
745972|NCT00083551|P2|Participant Flow|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
745973|NCT00083551|P1|Participant Flow|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
745974|NCT00083551|O2|Outcome|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
745975|NCT00083551|O1|Outcome|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
745976|NCT00083551|E2|Reported Event|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
745977|NCT00083551|E1|Reported Event|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
745978|NCT00083382|B1|Baseline|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
745979|NCT00083382|P1|Participant Flow|Thalidomide + Bisphosphonate|"200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy~Thalidomide: All Patients will receive thalidomide 200 mg as an oral once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)~Pamidronate: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.~Zometa: Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Dise"
745980|NCT00083382|O1|Outcome|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
745981|NCT00083382|E1|Reported Event|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
745982|NCT00082888|B1|Baseline|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
745983|NCT00082888|P1|Participant Flow|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
745984|NCT00082888|O1|Outcome|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
745985|NCT00082888|E1|Reported Event|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
745986|NCT00082810|B1|Baseline|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
745987|NCT00082810|P1|Participant Flow|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
745988|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
745989|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
745990|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
745991|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
745992|NCT00082810|E1|Reported Event|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
745994|NCT00082758|B3|Baseline|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
745995|NCT00082758|B2|Baseline|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
745996|NCT00082758|B1|Baseline|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
745997|NCT00082758|P3|Participant Flow|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
745998|NCT00082758|P2|Participant Flow|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
745999|NCT00082758|P1|Participant Flow|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
746000|NCT00082758|O3|Outcome|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
746001|NCT00082758|O2|Outcome|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
746002|NCT00082758|O1|Outcome|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
746003|NCT00082758|E3|Reported Event|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
746004|NCT00082758|E2|Reported Event|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
746005|NCT00082758|E1|Reported Event|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
746006|NCT00083226|B1|Baseline|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
746007|NCT00083226|P1|Participant Flow|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
746008|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
746009|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
746093|NCT00082407|P2|Participant Flow|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746010|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
746011|NCT00083226|E1|Reported Event|Doxorubicin+Bortezomib|Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
746012|NCT00083174|B3|Baseline|Total|Total of all reporting groups
746013|NCT00083174|B2|Baseline|Randomization Period: Placebo|one tablet daily in am
746014|NCT00083174|B1|Baseline|Randomization Period: Exemestane|one 25 mg tablet daily in am
746015|NCT00083174|P3|Participant Flow|Open-label Extension: Exemestane|one 25 mg tablet daily in am
746016|NCT00083174|P2|Participant Flow|Randomization Period: Placebo|one tablet daily in am
746017|NCT00083174|P1|Participant Flow|Randomization Period: Exemestane|one 25 mg tablet daily in am
746018|NCT00083174|O2|Outcome|Randomization Period: Placebo|one tablet daily in am
746019|NCT00083174|O1|Outcome|Randomization Period: Exemestane|one 25 mg tablet daily in am
746020|NCT00083174|O2|Outcome|Randomization Period: Placebo|one tablet daily in am
746021|NCT00083174|O1|Outcome|Randomization Period: Exemestane|one 25 mg tablet daily in am
746022|NCT00083174|O2|Outcome|Randomization Period: Placebo|one tablet daily in am
746023|NCT00083174|O1|Outcome|Randomization Period: Exemestane|one 25 mg tablet daily in am
746024|NCT00083174|O2|Outcome|Randomization Period: Placebo|one tablet daily in am
746025|NCT00083174|O1|Outcome|Randomization Period: Exemestane|one 25 mg tablet daily in am
746026|NCT00083174|O2|Outcome|Randomization Period: Placebo|one tablet daily in am
746027|NCT00083174|O1|Outcome|Randomization Period: Exemestane|one 25 mg tablet daily in am
746028|NCT00083174|O2|Outcome|Randomization Period: Placebo|one tablet daily in am
746029|NCT00083174|O1|Outcome|Randomization Period: Exemestane|one 25 mg tablet daily in am
746030|NCT00083174|O2|Outcome|Randomization Period: Placebo|Placebo tablet daily
746031|NCT00083174|O1|Outcome|Randomization Period: Exemestane|25 mg of exemestane tablet daily
746032|NCT00083174|O1|Outcome|Open-label Extension: Exemestane|"one 25 mg tablet daily in am~exemestane: one 25 mg tablet daily in am"
746033|NCT00083174|E3|Reported Event|Open-label Extension: Exemestane|one 25 mg tablet daily in am
746034|NCT00083174|E2|Reported Event|Randomization Period: Placebo|one tablet daily in am
746035|NCT00083174|E1|Reported Event|Randomization Period: Exemestane|one 25 mg tablet daily in am
746036|NCT00083122|B3|Baseline|Total|Total of all reporting groups
746037|NCT00083122|B2|Baseline|Group 2 (Platin Sensitive)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746038|NCT00083122|B1|Baseline|Group 1 (Platin Resistant)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746039|NCT00083122|P2|Participant Flow|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746040|NCT00083122|P1|Participant Flow|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746041|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746042|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746043|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746044|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746045|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746046|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746047|NCT00083122|E1|Reported Event|Group 1 and Group 2 Combined|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
746048|NCT00082433|B3|Baseline|Total|Total of all reporting groups
746049|NCT00082433|B2|Baseline|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746050|NCT00082433|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746051|NCT00082433|P2|Participant Flow|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746052|NCT00082433|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746054|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746055|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746056|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746057|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746058|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746059|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746060|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746061|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746062|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746063|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746064|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746065|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746066|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746067|NCT00082433|E2|Reported Event|Ixabepilone + Capecitabine|
746068|NCT00082433|E1|Reported Event|Capecitabine|
746069|NCT00082381|B3|Baseline|Total|Total of all reporting groups
746070|NCT00082381|B2|Baseline|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746071|NCT00082381|B1|Baseline|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746072|NCT00082381|P2|Participant Flow|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746073|NCT00082381|P1|Participant Flow|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746074|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746075|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746076|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746077|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746078|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746079|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746080|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746081|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746082|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746083|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746084|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746085|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746086|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746087|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746088|NCT00082381|E2|Reported Event|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
746089|NCT00082381|E1|Reported Event|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
746090|NCT00082407|B3|Baseline|Total|Total of all reporting groups
746091|NCT00082407|B2|Baseline|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746092|NCT00082407|B1|Baseline|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746094|NCT00082407|P1|Participant Flow|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746095|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746096|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746097|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746098|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746099|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746100|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746101|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746102|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746103|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746104|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746105|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746106|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746107|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746108|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746109|NCT00082407|E2|Reported Event|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
746110|NCT00082407|E1|Reported Event|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
746111|NCT00082368|B1|Baseline|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
746112|NCT00082368|P1|Participant Flow|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
746113|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
746114|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
746115|NCT00082368|E1|Reported Event|PET Imaging With Tc-94m Sestamibi|"Positron Emission Tomography (PET) sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active National Cancer Institute (NCI) protocol for treatment of cancer will undergo a PET sestamibi scan"
746116|NCT00082355|B1|Baseline|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
746117|NCT00082355|P1|Participant Flow|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
746118|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
746119|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
746120|NCT00082355|E1|Reported Event|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
746121|NCT00082342|B3|Baseline|Total|Total of all reporting groups
746122|NCT00082342|B2|Baseline|Sham tDCS|Subjects received sham transcranial direct current stimulation
746123|NCT00082342|B1|Baseline|Real tDCS|Subjects received real transcranial direct current stimulation
746124|NCT00082342|P2|Participant Flow|Sham tDCS|"Subjects receiving sham transcranial direct current stimulation, had electrodes placed on the subjects head in a manner which caused a temporary tingling sensation without effects on the brain. Subjects receiving sham transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication."
746274|NCT00081458|P1|Participant Flow|Placebo|Placebo injected subcutaneously daily
746125|NCT00082342|P1|Participant Flow|Real tDCS|"Transcranial direct current stimulation (tDCS) is a method of non-invasive brain stimulation whereby a direct current is applied to the brain via surface electrodes on the head for a specified time period. It is a form of neurostimulation. Subjects receiving real transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication. A battery driven stimulator, Phoresor II Model PM850 delivered the tDCS through electrodes."
746126|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving sham tDCS.
746127|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving real tDCS.
746128|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving sham tDCS.
746129|NCT00082342|O1|Outcome|Real tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving real tDCS.
746130|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The motor UPDRS score off medication while receiving sham tDCS
746131|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The motor UPDRS score off medication while receiving real tDCS
746132|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The motor UPDRS score on medication while receiving sham tDCS
746133|NCT00082342|O1|Outcome|Real tDCS While on Medication|The motor UPDRS score on medication while receiving real tDCS
746134|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The total UPDRS score off medication while receiving sham tDCS
746135|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The total UPDRS score off medication while receiving real tDCS
746136|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The total UPDRS score on medication while receiving sham tDCS
746137|NCT00082342|O1|Outcome|Real tDCS While on Medication|The total UPDRS score on medication while receiving real tDCS
746138|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
746139|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
746140|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
746141|NCT00082342|O1|Outcome|Real tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
746142|NCT00082342|E2|Reported Event|Sham tDCS|Subjects received sham transcranial direct current stimulation
746143|NCT00082342|E1|Reported Event|Real tDCS|Subjects received real transcranial direct current stimulation
746144|NCT00082329|B1|Baseline|AMD 3100 (Mozobil Plerixafor)|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~AMD 3100 (Mozobil plerixafor) : Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis"
746145|NCT00082329|P1|Participant Flow|AMD 3100 (Mozobil Plerixafor)|Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
746146|NCT00082329|O1|Outcome|AMD 3100 and G-CSF Responders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
746147|NCT00082329|E1|Reported Event|AMD 3100 & G-CSF Respnders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
746148|NCT00082173|B3|Baseline|Total|Total of all reporting groups
746149|NCT00082173|B2|Baseline|Control Arm (EMB)|
746150|NCT00082173|B1|Baseline|Experimental Arm (Moxi)|
746151|NCT00082173|P2|Participant Flow|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
746152|NCT00082173|P1|Participant Flow|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
746153|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
746154|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
746155|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
746156|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
746157|NCT00082173|E2|Reported Event|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
746158|NCT00082173|E1|Reported Event|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
746159|NCT00003726|B1|Baseline|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
746160|NCT00003726|P1|Participant Flow|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
746275|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
746161|NCT00003726|O1|Outcome|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
746162|NCT00003726|E1|Reported Event|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
746163|NCT00081939|B1|Baseline|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
746164|NCT00081939|P1|Participant Flow|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
746165|NCT00081939|O1|Outcome|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
746166|NCT00081939|E1|Reported Event|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
746167|NCT00082017|B1|Baseline|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
746168|NCT00082017|P2|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|"Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
746169|NCT00082017|P1|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days."
746170|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
746171|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
746172|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
746173|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
746174|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
746175|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
746176|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
746177|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
746178|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
746179|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
746180|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
746181|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
746182|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
746183|NCT00082017|E1|Reported Event|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
746184|NCT00081861|B1|Baseline|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
746185|NCT00081861|P1|Participant Flow|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
746186|NCT00081861|O1|Outcome|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
746187|NCT00081861|E1|Reported Event|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
746188|NCT00081770|B4|Baseline|Total|Total of all reporting groups
746189|NCT00081770|B3|Baseline|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746190|NCT00081770|B2|Baseline|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746191|NCT00081770|B1|Baseline|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746192|NCT00081770|P3|Participant Flow|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746193|NCT00081770|P2|Participant Flow|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746194|NCT00081770|P1|Participant Flow|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746195|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746196|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746197|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746198|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746199|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746200|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746276|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
746201|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746202|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746203|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746204|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746205|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746206|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
746207|NCT00081770|E3|Reported Event|PEGASYS 180 ug/wk Plus COPEGUS|
746208|NCT00081770|E2|Reported Event|PegIntron 1.0 ug/kg/wk Plus REBETOL|
746209|NCT00081770|E1|Reported Event|PegIntron 1.5 ug/kg/wk Plus REBETOL|
746210|NCT00081731|B3|Baseline|Total|Total of all reporting groups
746211|NCT00081731|B2|Baseline|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746212|NCT00081731|B1|Baseline|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746213|NCT00081731|P2|Participant Flow|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746214|NCT00081731|P1|Participant Flow|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746215|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746216|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746217|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746218|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746219|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746220|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746221|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746222|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746223|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746224|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746225|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746226|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746227|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746228|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746229|NCT00081731|E2|Reported Event|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
746230|NCT00081731|E1|Reported Event|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
746231|NCT00081653|B3|Baseline|Total|Total of all reporting groups
746232|NCT00081653|B2|Baseline|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746233|NCT00081653|B1|Baseline|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746234|NCT00081653|P2|Participant Flow|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746235|NCT00081653|P1|Participant Flow|Ibandronate 100 Milligrams (mg)|100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746236|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746237|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandgronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746238|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746239|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746240|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746241|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746242|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746243|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746244|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746245|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746246|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746247|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746248|NCT00081653|E2|Reported Event|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
746249|NCT00081653|E1|Reported Event|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
746250|NCT00081497|B3|Baseline|Total|Total of all reporting groups
746251|NCT00081497|B2|Baseline|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
746252|NCT00081497|B1|Baseline|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
746253|NCT00081497|P2|Participant Flow|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
746254|NCT00081497|P1|Participant Flow|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
746255|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
746256|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
746257|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
746258|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
746259|NCT00081497|O4|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
746260|NCT00081497|O3|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
746261|NCT00081497|O2|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR >60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
746262|NCT00081497|O1|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR >60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
746263|NCT00081497|O2|Outcome|Fabrazyme Period - AGAL02503 (NCT00081497)|Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.
746264|NCT00081497|O1|Outcome|Placebo Period - AGAL-008-00 (NCT00074984)|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).
746265|NCT00081497|E3|Reported Event|Total|
746266|NCT00081497|E2|Reported Event|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
746267|NCT00081497|E1|Reported Event|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
746268|NCT00081458|B4|Baseline|Total|Total of all reporting groups
746269|NCT00081458|B3|Baseline|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
746270|NCT00081458|B2|Baseline|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
746271|NCT00081458|B1|Baseline|Placebo|Placebo injected subcutaneously daily
746272|NCT00081458|P3|Participant Flow|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
746273|NCT00081458|P2|Participant Flow|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
746279|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
746280|NCT00081458|O1|Outcome|Placebo|Placebo injectable subcutaneously daily into the thigh or abdomen
746281|NCT00081458|E3|Reported Event|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
746282|NCT00081458|E2|Reported Event|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
746283|NCT00081458|E1|Reported Event|Placebo|Placebo injected subcutaneously daily
746284|NCT00081328|B4|Baseline|Total|Total of all reporting groups
746285|NCT00081328|B3|Baseline|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746286|NCT00081328|B2|Baseline|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746287|NCT00081328|B1|Baseline|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746288|NCT00081328|P3|Participant Flow|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid, encapsulated, provided in weekly packets~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746289|NCT00081328|P2|Participant Flow|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid, provided encapsulated in weekly packets"
746290|NCT00081328|P1|Participant Flow|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid, provided encapsulated in weekly packets"
746291|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746292|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746293|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746294|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746295|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746296|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746297|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746298|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746299|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746300|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746301|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746302|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746303|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746304|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746305|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746306|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746307|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746308|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746337|NCT00081263|B2|Baseline|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
746338|NCT00081263|B1|Baseline|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
746309|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746310|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746311|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746312|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746313|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746314|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746315|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746316|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746317|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746318|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746319|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746320|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746321|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746322|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746323|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746324|NCT00081328|E3|Reported Event|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
746325|NCT00081328|E2|Reported Event|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
746326|NCT00081328|E1|Reported Event|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
746327|NCT00081289|B3|Baseline|Total|Total of all reporting groups
746328|NCT00081289|B2|Baseline|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746329|NCT00081289|B1|Baseline|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746330|NCT00081289|P2|Participant Flow|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746331|NCT00081289|P1|Participant Flow|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746332|NCT00081289|O2|Outcome|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746333|NCT00081289|O1|Outcome|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746334|NCT00081289|E2|Reported Event|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746335|NCT00081289|E1|Reported Event|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
746336|NCT00081263|B3|Baseline|Total|Total of all reporting groups
746339|NCT00081263|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
746340|NCT00081263|P1|Participant Flow|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
746341|NCT00081263|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
746342|NCT00081263|O1|Outcome|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
746343|NCT00081263|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
746344|NCT00081263|O1|Outcome|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
746345|NCT00081263|E2|Reported Event|Arm II (Placebo)|"Patients receive oral placebo once daily for 14-18 weeks.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given orally"
746346|NCT00081263|E1|Reported Event|Arm I (Celecoxib)|"Patients receive oral celecoxib once daily for 14-18 weeks.~Celecoxib: Given orally~Laboratory Biomarker Analysis: Correlative studies"
746347|NCT00081159|B3|Baseline|Total|Total of all reporting groups
746348|NCT00081159|B2|Baseline|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
746349|NCT00081159|B1|Baseline|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
746350|NCT00081159|P2|Participant Flow|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
746351|NCT00081159|P1|Participant Flow|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin intravenous (IV) on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
746352|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
746353|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
746354|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
746355|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
746356|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
746357|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
746358|NCT00081159|E2|Reported Event|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
746359|NCT00081159|E1|Reported Event|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
746360|NCT00080938|B1|Baseline|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
746361|NCT00080938|P1|Participant Flow|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
746362|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
746363|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
746364|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
746365|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
746366|NCT00080938|E1|Reported Event|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
746367|NCT00080912|B3|Baseline|Total|Total of all reporting groups
746368|NCT00080912|B2|Baseline|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
746369|NCT00080912|B1|Baseline|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
746370|NCT00080912|P2|Participant Flow|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
746371|NCT00080912|P1|Participant Flow|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
746372|NCT00080912|O2|Outcome|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
746373|NCT00080912|O1|Outcome|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
746374|NCT00080912|E2|Reported Event|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
746375|NCT00080912|E1|Reported Event|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
746376|NCT00080899|B1|Baseline|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
746377|NCT00080899|P1|Participant Flow|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
746378|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
746379|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
746380|NCT00080899|E1|Reported Event|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
746381|NCT00080535|B1|Baseline|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
746382|NCT00080535|P1|Participant Flow|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
746383|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
746744|NCT00078754|P1|Participant Flow|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
746384|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
746385|NCT00080535|E1|Reported Event|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
746386|NCT00080483|B3|Baseline|Total|Total of all reporting groups
746387|NCT00080483|B2|Baseline|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
746388|NCT00080483|B1|Baseline|1Testosterone Only|Testosterone transdermally 5 g a day
746389|NCT00080483|P2|Participant Flow|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
746390|NCT00080483|P1|Participant Flow|1Testosterone Only|Testosterone transdermally 5 g a day
746391|NCT00080483|O2|Outcome|2 The Effects of Testosterone Alone on Structural and Mechanic|"AndroGel transdermally 5 g a day for two years~testosterone: AndroGel transdermally 5 g a day for two years"
746392|NCT00080483|O1|Outcome|1 The Effects of Testosterone Combined With G|"AndroGel transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day~AndroGel plus somatropin: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years"
746393|NCT00080483|E2|Reported Event|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
746394|NCT00080483|E1|Reported Event|1Testosterone Only|Testosterone transdermally 5 g a day
746395|NCT00002525|B3|Baseline|Total|Total of all reporting groups
746396|NCT00002525|B2|Baseline|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746397|NCT00002525|B1|Baseline|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746398|NCT00002525|P2|Participant Flow|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746399|NCT00002525|P1|Participant Flow|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746400|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746401|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746402|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746403|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746404|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746491|NCT00002540|E1|Reported Event|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746405|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746406|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746407|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746408|NCT00002525|E4|Reported Event|Adjuvant Chemotherapy-- 5-FU+Leucovovin|"After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy:~Levamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months.~5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
746409|NCT00002525|E3|Reported Event|Adjuvant Chemotherapy-- 5-FU+Levamisolem|"Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy:~Leucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin~A cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
746410|NCT00002525|E2|Reported Event|Arm II (No Perioperative 5-FU)|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746411|NCT00002525|E1|Reported Event|Arm I (Perioperative 5-FU)|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
746412|NCT00080470|B3|Baseline|Total|Total of all reporting groups
746413|NCT00080470|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
746414|NCT00080470|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
746415|NCT00080470|P2|Participant Flow|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
746416|NCT00080470|P1|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
746417|NCT00080470|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
746418|NCT00080470|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
746419|NCT00080470|O2|Outcome|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
746420|NCT00080470|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
746421|NCT00080470|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
746422|NCT00080470|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
746423|NCT00080301|B3|Baseline|Total|Total of all reporting groups
746424|NCT00080301|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746425|NCT00080301|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746426|NCT00080301|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746427|NCT00080301|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746428|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746429|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746430|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746431|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
746432|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746433|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746434|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746435|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746436|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746437|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746438|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746439|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746440|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
746441|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
746442|NCT00080301|E2|Reported Event|Ixabepilone + Capecitabine|
746443|NCT00080301|E1|Reported Event|Capecitabine|
746444|NCT00080288|B3|Baseline|Total|Total of all reporting groups
746445|NCT00080288|B2|Baseline|Placebo|Matching placebo tablets once daily
746446|NCT00080288|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
746447|NCT00080288|P2|Participant Flow|Placebo|Matching placebo tablets once daily
746448|NCT00080288|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
746449|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
746450|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
746451|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
746452|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
746453|NCT00080288|E2|Reported Event|Placebo|Matching placebo tablets once daily
746454|NCT00080288|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
746455|NCT00080223|B1|Baseline|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746456|NCT00080223|P1|Participant Flow|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746457|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746458|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746459|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746460|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746492|NCT00080119|B5|Baseline|Total|Total of all reporting groups
746493|NCT00080119|B4|Baseline|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
746955|NCT00078286|B1|Baseline|Sertraline|Participants will take sertraline for 12 weeks
746461|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746462|NCT00080223|E1|Reported Event|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
746463|NCT00002540|B3|Baseline|Total|Total of all reporting groups
746464|NCT00002540|B2|Baseline|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746465|NCT00002540|B1|Baseline|Control|Participants receive standard medical care.
746466|NCT00002540|P2|Participant Flow|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746467|NCT00002540|P1|Participant Flow|Control|Participants receive standard medical care.
746468|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746469|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746470|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746471|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
746472|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746473|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746474|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746475|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746476|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746477|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746478|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746479|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746480|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746481|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746482|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
746483|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746484|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
746485|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746486|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
746487|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746488|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
746489|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
746490|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
746577|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
746494|NCT00080119|B3|Baseline|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
746495|NCT00080119|B2|Baseline|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
746496|NCT00080119|B1|Baseline|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
746497|NCT00080119|P4|Participant Flow|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
746498|NCT00080119|P3|Participant Flow|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
746499|NCT00080119|P2|Participant Flow|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
746500|NCT00080119|P1|Participant Flow|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
746501|NCT00080119|O4|Outcome|HIVpos/PL|
746502|NCT00080119|O3|Outcome|HIVpos/INH|
746503|NCT00080119|O2|Outcome|HIVneg/PL|
746504|NCT00080119|O1|Outcome|HIVneg/INH|
746505|NCT00080119|O4|Outcome|HIVpos/PL|
746506|NCT00080119|O3|Outcome|HIVpos/INH|
746507|NCT00080119|O2|Outcome|HIVneg/PL|
746508|NCT00080119|O1|Outcome|HIVneg/INH|
746509|NCT00080119|O4|Outcome|HIVpos/PL|
746510|NCT00080119|O3|Outcome|HIVpos/INH|
746511|NCT00080119|O2|Outcome|HIVneg/PL|
746512|NCT00080119|O1|Outcome|HIVneg/INH|
746513|NCT00080119|O4|Outcome|HIVpos/PL|
746514|NCT00080119|O3|Outcome|HIVpos/INH|
746515|NCT00080119|O2|Outcome|HIVneg/PL|
746516|NCT00080119|O1|Outcome|HIVneg/INH|
746517|NCT00080119|O2|Outcome|HIVneg/PL|
746518|NCT00080119|O1|Outcome|HIVneg/INH|
746519|NCT00080119|O2|Outcome|HIVpos/PL|
746520|NCT00080119|O1|Outcome|HIVpos/INH|
746521|NCT00080119|O2|Outcome|HIVpos/PL|
746522|NCT00080119|O1|Outcome|HIVpos/INH|
746523|NCT00080119|O2|Outcome|HIVneg/PL|
746524|NCT00080119|O1|Outcome|HIVneg/INH|
746525|NCT00080119|O2|Outcome|HIVpos/PL|
746526|NCT00080119|O1|Outcome|HIVpos/INH|
746527|NCT00080119|E4|Reported Event|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
746528|NCT00080119|E3|Reported Event|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
746529|NCT00080119|E2|Reported Event|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
746530|NCT00080119|E1|Reported Event|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
746531|NCT00079937|B3|Baseline|Total|Total of all reporting groups
746532|NCT00079937|B2|Baseline|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746533|NCT00079937|B1|Baseline|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746534|NCT00079937|P2|Participant Flow|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746535|NCT00079937|P1|Participant Flow|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746578|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
746536|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746537|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746538|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746539|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746540|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746541|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746542|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746543|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746544|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746545|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746546|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746547|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746548|NCT00079937|E2|Reported Event|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746549|NCT00079937|E1|Reported Event|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
746550|NCT00009737|B3|Baseline|Total|Total of all reporting groups
746956|NCT00078286|P2|Participant Flow|Placebo|Participants will take placebo for 12 weeks
746551|NCT00009737|B2|Baseline|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746552|NCT00009737|B1|Baseline|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746553|NCT00009737|P2|Participant Flow|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746554|NCT00009737|P1|Participant Flow|Capecitabine|Participants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746555|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746556|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746557|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746558|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746559|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746560|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746561|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746562|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746563|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746564|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746565|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746566|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746567|NCT00009737|E2|Reported Event|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
746568|NCT00009737|E1|Reported Event|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
746569|NCT00079781|B4|Baseline|Total|Total of all reporting groups
746570|NCT00079781|B3|Baseline|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
746571|NCT00079781|B2|Baseline|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
746572|NCT00079781|B1|Baseline|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
746573|NCT00079781|P3|Participant Flow|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
746574|NCT00079781|P2|Participant Flow|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
746575|NCT00079781|P1|Participant Flow|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
746576|NCT00079781|O1|Outcome|Treatment Population|Open Label Group and Treatment Group combined.
746579|NCT00079781|E2|Reported Event|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period). Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
746580|NCT00079781|E1|Reported Event|Treatment Population|Open Label Group and Treatment Group combined.
746581|NCT00079677|B3|Baseline|Total|Total of all reporting groups
746582|NCT00079677|B2|Baseline|Placebo|Matching placebo tablets once daily
746583|NCT00079677|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746584|NCT00079677|P2|Participant Flow|Placebo|Matching placebo tablets once daily
746585|NCT00079677|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746586|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
746587|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746588|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
746589|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746590|NCT00079677|E2|Reported Event|Placebo|Matching placebo tablets once daily
746591|NCT00079677|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746592|NCT00002601|B1|Baseline|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
746593|NCT00002601|P1|Participant Flow|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
746594|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
746595|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
746596|NCT00002601|O2|Outcome|Cycle 2|Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
746597|NCT00002601|O1|Outcome|Cycle 1|Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
746598|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
746599|NCT00002601|E1|Reported Event|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
746600|NCT00079417|B1|Baseline|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
746601|NCT00079417|P1|Participant Flow|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
746616|NCT00079339|B1|Baseline|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
746745|NCT00078754|O3|Outcome|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
746602|NCT00079417|O1|Outcome|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
746603|NCT00079417|E1|Reported Event|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
746604|NCT00079391|B1|Baseline|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746605|NCT00079391|P1|Participant Flow|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746606|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746607|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746608|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|"Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. Cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant."
746609|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746610|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746611|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746612|NCT00079391|E1|Reported Event|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
746613|NCT00079339|B4|Baseline|Total|Total of all reporting groups
746614|NCT00079339|B3|Baseline|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
746615|NCT00079339|B2|Baseline|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
746617|NCT00079339|P3|Participant Flow|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
746618|NCT00079339|P2|Participant Flow|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
746619|NCT00079339|P1|Participant Flow|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
746620|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
746621|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
746622|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI scan.
746623|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI diffusion scan.
746624|NCT00079339|O1|Outcome|Tipifarnib - Any Dose Level|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI perfusion scan.
746625|NCT00079339|O1|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
746626|NCT00079339|O3|Outcome|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
746627|NCT00079339|O2|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
746628|NCT00079339|O1|Outcome|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
746629|NCT00079339|E3|Reported Event|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
746699|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
746630|NCT00079339|E2|Reported Event|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
746631|NCT00079339|E1|Reported Event|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
746632|NCT00079326|B3|Baseline|Total|Total of all reporting groups
746633|NCT00079326|B2|Baseline|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746634|NCT00079326|B1|Baseline|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746635|NCT00079326|P2|Participant Flow|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746636|NCT00079326|P1|Participant Flow|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746637|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746638|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746639|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746640|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
746641|NCT00079326|E1|Reported Event|All Study Participants|All Adverse Events and Serious Adverse event data was pooled because all participants received the same treatment.
746642|NCT00079274|B8|Baseline|Total|Total of all reporting groups
746643|NCT00079274|B7|Baseline|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
746644|NCT00079274|B6|Baseline|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746645|NCT00079274|B5|Baseline|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746646|NCT00079274|B4|Baseline|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746647|NCT00079274|B3|Baseline|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746648|NCT00079274|B2|Baseline|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746649|NCT00079274|B1|Baseline|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746704|NCT00078949|B3|Baseline|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
746650|NCT00079274|P7|Participant Flow|Arm G (Locally Directed Therapy)|"Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
746651|NCT00079274|P6|Participant Flow|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746652|NCT00079274|P5|Participant Flow|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given I~cetuximab: Given IV"
746653|NCT00079274|P4|Participant Flow|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746654|NCT00079274|P3|Participant Flow|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746655|NCT00079274|P2|Participant Flow|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746656|NCT00079274|P1|Participant Flow|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746657|NCT00079274|O2|Outcome|Mutant KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm A patients.
746658|NCT00079274|O1|Outcome|Mutant KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm D patients.
746659|NCT00079274|O2|Outcome|Wild-type KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
746660|NCT00079274|O1|Outcome|Wild-type KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
746661|NCT00079274|E7|Reported Event|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists."
746662|NCT00079274|E6|Reported Event|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746663|NCT00079274|E5|Reported Event|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746664|NCT00079274|E4|Reported Event|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
746665|NCT00079274|E3|Reported Event|Arm C (Combination Chemotherapy)|"Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746666|NCT00079274|E2|Reported Event|Arm B (Combination Chemotherapy)|"Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746667|NCT00079274|E1|Reported Event|Arm A (Combination Chemotherapy)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
746700|NCT00079001|E2|Reported Event|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
746860|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
746861|NCT00076687|O1|Outcome|Placebo|Placebo
746668|NCT00079183|B1|Baseline|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746669|NCT00079183|P1|Participant Flow|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746670|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746671|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746672|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746673|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746674|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746675|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746676|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746677|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746678|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746701|NCT00079001|E1|Reported Event|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
746702|NCT00078949|B5|Baseline|Total|Total of all reporting groups
746703|NCT00078949|B4|Baseline|Observation|Patients undergo observation only.
746679|NCT00079183|O1|Outcome|Sirolimus|"Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.~sirolimus: Given PO~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
746680|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746681|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746682|NCT00079183|E1|Reported Event|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
746683|NCT00079040|B1|Baseline|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
746684|NCT00079040|P1|Participant Flow|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
746685|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
746686|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
746687|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
746688|NCT00079040|E1|Reported Event|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
746689|NCT00079001|B3|Baseline|Total|Total of all reporting groups
746690|NCT00079001|B2|Baseline|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
746691|NCT00079001|B1|Baseline|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
746692|NCT00079001|P2|Participant Flow|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
746693|NCT00079001|P1|Participant Flow|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
746694|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
746695|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
746696|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
746697|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
746698|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
746705|NCT00078949|B2|Baseline|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
746706|NCT00078949|B1|Baseline|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
746707|NCT00078949|P4|Participant Flow|Observation|Patients undergo observation only.
746708|NCT00078949|P3|Participant Flow|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
746709|NCT00078949|P2|Participant Flow|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
746710|NCT00078949|P1|Participant Flow|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
746711|NCT00078949|O2|Outcome|Observation|Patients undergo observation only.
746712|NCT00078949|O1|Outcome|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
746713|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
746714|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
746715|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
746716|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
746717|NCT00078949|E4|Reported Event|Observation|Patients undergo observation only.
746718|NCT00078949|E3|Reported Event|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
746719|NCT00078949|E2|Reported Event|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
746720|NCT00078949|E1|Reported Event|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
746721|NCT00078767|B3|Baseline|Total|Total of all reporting groups
746722|NCT00078767|B2|Baseline|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746723|NCT00078767|B1|Baseline|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746724|NCT00078767|P2|Participant Flow|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746725|NCT00078767|P1|Participant Flow|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746726|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746742|NCT00078754|P3|Participant Flow|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
746743|NCT00078754|P2|Participant Flow|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
746727|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746728|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746729|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746730|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746731|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746732|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746733|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746734|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746735|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746736|NCT00078767|E2|Reported Event|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
746737|NCT00078767|E1|Reported Event|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
746738|NCT00078754|B4|Baseline|Total|Total of all reporting groups
746739|NCT00078754|B3|Baseline|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
746740|NCT00078754|B2|Baseline|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
746741|NCT00078754|B1|Baseline|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
746862|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
746746|NCT00078754|O2|Outcome|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
746747|NCT00078754|O1|Outcome|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
746748|NCT00078754|E3|Reported Event|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
746749|NCT00078754|E2|Reported Event|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
746750|NCT00078754|E1|Reported Event|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
746751|NCT00078728|B3|Baseline|Total|Total of all reporting groups
746752|NCT00078728|B2|Baseline|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
746753|NCT00078728|B1|Baseline|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
746754|NCT00078728|P2|Participant Flow|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
746755|NCT00078728|P1|Participant Flow|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
746756|NCT00078728|O2|Outcome|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
746757|NCT00078728|O1|Outcome|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
746758|NCT00078728|O2|Outcome|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active intervention for 8 weeks but received an informational packet on anxiety disorders.
746759|NCT00078728|O1|Outcome|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
746760|NCT00078728|E2|Reported Event|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
746761|NCT00078728|E1|Reported Event|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
746762|NCT00078715|B1|Baseline|Overall Study|
746763|NCT00078715|P2|Participant Flow|Yohimbine Then Placebo|Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.
746764|NCT00078715|P1|Participant Flow|Placebo Then Yohimbine|Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same.
746765|NCT00078715|O2|Outcome|Yohimbine|Participants are randomized to blindly receive yohimbine for 8 days.
746766|NCT00078715|O1|Outcome|Placebo|Participants are randomized to blindly receive placebo for 8 days.
746767|NCT00078715|E2|Reported Event|Yohimbine|
746768|NCT00078715|E1|Reported Event|Placebo|
746769|NCT00005947|B3|Baseline|Total|Total of all reporting groups
746770|NCT00005947|B2|Baseline|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
746771|NCT00005947|B1|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
746772|NCT00005947|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
746773|NCT00005947|P1|Participant Flow|Sipuleucel-T|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
746774|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
746775|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
746776|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo
746777|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T.
746778|NCT00005947|E2|Reported Event|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
746779|NCT00005947|E1|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
746780|NCT00078559|B1|Baseline|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746863|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
746864|NCT00076687|O1|Outcome|Placebo|Placebo
746865|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
746781|NCT00078559|P1|Participant Flow|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746782|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746783|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746784|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746785|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746786|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746787|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746788|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746789|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746790|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746791|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746792|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746866|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
746867|NCT00076687|O1|Outcome|Placebo|Placebo
746868|NCT00076687|E3|Reported Event|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
746869|NCT00076687|E2|Reported Event|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
746793|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746794|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746795|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746796|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746797|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746798|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
746799|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746800|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746801|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746802|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746803|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746804|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746870|NCT00076687|E1|Reported Event|Placebo|Placebo
746871|NCT00078403|B4|Baseline|Total|Total of all reporting groups
746957|NCT00078286|P1|Participant Flow|Sertraline|Participants will take sertraline for 12 weeks
746958|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
746805|NCT00078559|E1|Reported Event|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
746806|NCT00002597|B3|Baseline|Total|Total of all reporting groups
746807|NCT00002597|B2|Baseline|Radiation Therapy Alone|Radiation therapy alone
746808|NCT00002597|B1|Baseline|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746809|NCT00002597|P2|Participant Flow|Radiation Therapy Alone|Radiation therapy alone
746810|NCT00002597|P1|Participant Flow|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746811|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746812|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746813|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746814|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746815|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746816|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746817|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746818|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746819|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746820|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746821|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746822|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746823|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746824|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746825|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746826|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746827|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
746828|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
746829|NCT00002597|E2|Reported Event|Radiation Therapy Alone|Radiation therapy alone
746830|NCT00002597|E1|Reported Event|Neoadjuvant TAS 2 Months Before and During RT|Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
746831|NCT00078377|B4|Baseline|Total|Total of all reporting groups
746832|NCT00078377|B3|Baseline|Placebo|Matching placebo tablets once daily in the morning
746833|NCT00078377|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746834|NCT00078377|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746835|NCT00078377|P3|Participant Flow|Placebo|Matching placebo tablets once daily in the morning
746836|NCT00078377|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746837|NCT00078377|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746838|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
746839|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
746840|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746841|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746842|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
746843|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
746844|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746845|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746846|NCT00078377|E3|Reported Event|Placebo|Matching placebo tablets once daily in the morning
746847|NCT00078377|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746848|NCT00078377|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746849|NCT00076687|B4|Baseline|Total|Total of all reporting groups
746850|NCT00076687|B3|Baseline|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
746851|NCT00076687|B2|Baseline|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
746852|NCT00076687|B1|Baseline|Placebo|Placebo
746853|NCT00076687|P3|Participant Flow|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
746854|NCT00076687|P2|Participant Flow|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
746855|NCT00076687|P1|Participant Flow|Placebo|Placebo
746856|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
746857|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
746858|NCT00076687|O1|Outcome|Placebo|Placebo
746859|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
746872|NCT00078403|B3|Baseline|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746873|NCT00078403|B2|Baseline|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746874|NCT00078403|B1|Baseline|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746875|NCT00078403|P3|Participant Flow|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746876|NCT00078403|P2|Participant Flow|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746877|NCT00078403|P1|Participant Flow|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746878|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746879|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746880|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746881|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746882|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746883|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746884|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation..
746885|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746886|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746887|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746950|NCT00078312|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
746888|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746889|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746890|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746891|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746892|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746893|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746894|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746895|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746896|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746897|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746898|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746899|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746900|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746901|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746902|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746903|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746904|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746951|NCT00078312|O1|Outcome|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
746905|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746906|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746907|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746908|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746909|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746910|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746911|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746912|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746913|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746914|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746915|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746916|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746917|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746918|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746919|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746920|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746952|NCT00078312|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
746953|NCT00078286|B3|Baseline|Total|Total of all reporting groups
746954|NCT00078286|B2|Baseline|Placebo|Participants will take placebo for 12 weeks
746921|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746922|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746923|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746924|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746925|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746926|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746927|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
746928|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
746929|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
746930|NCT00078403|E3|Reported Event|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & ribavirin [RBV] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.
746931|NCT00078403|E2|Reported Event|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
746932|NCT00078403|E1|Reported Event|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
746933|NCT00078325|B4|Baseline|Total|Total of all reporting groups
746934|NCT00078325|B3|Baseline|Placebo|Matching placebo tablets once daily
746935|NCT00078325|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746936|NCT00078325|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746937|NCT00078325|P3|Participant Flow|Placebo|Matching placebo tablets once daily
746938|NCT00078325|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746939|NCT00078325|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746940|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
746941|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746942|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746943|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
746944|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746945|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746946|NCT00078325|E3|Reported Event|Placebo|Matching placebo tablets once daily
746947|NCT00078325|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
746948|NCT00078325|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
746949|NCT00078312|B1|Baseline|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
746959|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
746960|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
746961|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
746962|NCT00078286|E2|Reported Event|Placebo|Serious adverse events in Placebo Arm
746963|NCT00078286|E1|Reported Event|Sertraline|Serious adverse events in Sertraline Arm
746964|NCT00077974|B1|Baseline|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746965|NCT00077974|P1|Participant Flow|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746966|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746967|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746968|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746969|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746970|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746971|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746972|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746973|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746974|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746975|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746976|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746977|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746978|NCT00077974|E1|Reported Event|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
746979|NCT00077857|B3|Baseline|Total|Total of all reporting groups
746980|NCT00077857|B2|Baseline|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746981|NCT00077857|B1|Baseline|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746982|NCT00077857|P2|Participant Flow|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746983|NCT00077857|P1|Participant Flow|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746984|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746985|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746986|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746987|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746988|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746989|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746990|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746991|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746992|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746993|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746994|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746995|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
747215|NCT00077064|E1|Reported Event|Clinical Observation|Clinical observation
746996|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746997|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746998|NCT00077857|E2|Reported Event|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
746999|NCT00077857|E1|Reported Event|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
747000|NCT00077766|B3|Baseline|Total|Total of all reporting groups
747001|NCT00077766|B2|Baseline|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747002|NCT00077766|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747003|NCT00077766|P2|Participant Flow|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747004|NCT00077766|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV), every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 microgram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747005|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747006|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747007|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747008|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747009|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747010|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747011|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747012|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747013|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747014|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747015|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747016|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747017|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747018|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747019|NCT00077766|E2|Reported Event|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
747020|NCT00077766|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
747021|NCT00077922|B1|Baseline|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
747022|NCT00077922|P1|Participant Flow|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
747023|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
747024|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
747025|NCT00077922|E1|Reported Event|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
747026|NCT00077675|B3|Baseline|Total|Total of all reporting groups
747027|NCT00077675|B2|Baseline|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
747028|NCT00077675|B1|Baseline|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
747029|NCT00077675|P2|Participant Flow|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
747030|NCT00077675|P1|Participant Flow|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
747031|NCT00077675|O2|Outcome|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
747032|NCT00077675|O1|Outcome|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
747033|NCT00077675|E2|Reported Event|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
747034|NCT00077675|E1|Reported Event|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
747035|NCT00077649|B5|Baseline|Total|Total of all reporting groups
747036|NCT00077649|B4|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747037|NCT00077649|B3|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks.
747038|NCT00077649|B2|Baseline|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747039|NCT00077649|B1|Baseline|PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks.
747040|NCT00077649|P4|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747041|NCT00077649|P3|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747042|NCT00077649|P2|Participant Flow|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747043|NCT00077649|P1|Participant Flow|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
747044|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747045|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747046|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747047|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747048|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747049|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747050|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747051|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747052|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747053|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747054|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747113|NCT00077623|P3|Participant Flow|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747055|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747056|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747057|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747058|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747059|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747060|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747061|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747062|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747063|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747064|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747065|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747066|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747067|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747068|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747069|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747070|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747071|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747072|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747073|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747074|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747075|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747076|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
747077|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747078|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747079|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747080|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747202|NCT00077064|B2|Baseline|Captopril|Captopril: 50 mg t.i.d.
747081|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747082|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747083|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747084|NCT00077649|E4|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747085|NCT00077649|E3|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
747086|NCT00077649|E2|Reported Event|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
747087|NCT00077649|E1|Reported Event|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered [subcutaneously] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
747088|NCT00077636|B3|Baseline|Total|Total of all reporting groups
747089|NCT00077636|B2|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747090|NCT00077636|B1|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747091|NCT00077636|P2|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747092|NCT00077636|P1|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747093|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747094|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 16 weeks.
747095|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747096|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747097|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747098|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747099|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747100|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747101|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747102|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747103|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747104|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747105|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747106|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747107|NCT00077636|E2|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
747108|NCT00077636|E1|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
747109|NCT00077623|B4|Baseline|Total|Total of all reporting groups
747110|NCT00077623|B3|Baseline|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747111|NCT00077623|B2|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of<8000, 8000-16000, or >16000 IU/Week administered during the week preceding the switch to the study drug.
747112|NCT00077623|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of<8000, 8000-16000,or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
747114|NCT00077623|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747115|NCT00077623|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.
747116|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747117|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747118|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747119|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747120|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747121|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747122|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747123|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747124|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747125|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747126|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747127|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747128|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747129|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747130|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747131|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747132|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747133|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747134|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747135|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747136|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747203|NCT00077064|B1|Baseline|Observation|Clinical observation
747137|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747138|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747139|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747140|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747141|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747142|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747143|NCT00077623|E3|Reported Event|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
747144|NCT00077623|E2|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
747145|NCT00077623|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
747146|NCT00077610|B4|Baseline|Total|Total of all reporting groups
747147|NCT00077610|B3|Baseline|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747148|NCT00077610|B2|Baseline|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747149|NCT00077610|B1|Baseline|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747150|NCT00077610|P3|Participant Flow|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747151|NCT00077610|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747152|NCT00077610|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
747153|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747154|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose administered during the week preceding the switch to the study drug.
747155|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747156|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747157|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747158|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747159|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747160|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747161|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747162|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747163|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747164|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747165|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747166|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747167|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747168|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks
747169|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747170|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747171|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747172|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747173|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747174|NCT00077610|O3|Outcome|Epoetin (1-3x/Week)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747175|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747176|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 120,180 mcg) that was based on the Epoetin dose administered (<8000, 8000-16000, >16000 IU/Week) during the week preceding the switch to the study drug.
747177|NCT00077610|E3|Reported Event|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
747178|NCT00077610|E2|Reported Event|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747179|NCT00077610|E1|Reported Event|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
747180|NCT00077376|B1|Baseline|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747181|NCT00077376|P1|Participant Flow|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747204|NCT00077064|P2|Participant Flow|Captopril|Captopril: 50 mg t.i.d.
747205|NCT00077064|P1|Participant Flow|Clinical Observation|Clinical observation
747206|NCT00077064|O2|Outcome|Captopril|Captopril: 50 mg t.i.d.
747207|NCT00077064|O1|Outcome|Clinical Observation|Clinical observation
747182|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747183|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747184|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747185|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747186|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747187|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747188|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747189|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747190|NCT00077376|E1|Reported Event|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
747191|NCT00077207|B1|Baseline|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747192|NCT00077207|P1|Participant Flow|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747193|NCT00077207|O1|Outcome|Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747194|NCT00077207|O1|Outcome|Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747195|NCT00077207|O1|Outcome|Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747196|NCT00077207|O1|Outcome|Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747197|NCT00077207|O1|Outcome|Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747198|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747199|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747200|NCT00077207|E1|Reported Event|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
747201|NCT00077064|B3|Baseline|Total|Total of all reporting groups
747217|NCT00076999|B4|Baseline|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747218|NCT00076999|B3|Baseline|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747219|NCT00076999|B2|Baseline|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747220|NCT00076999|B1|Baseline|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747221|NCT00076999|P5|Participant Flow|TPV SEDDS 12-18 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
747222|NCT00076999|P4|Participant Flow|TPV SEDDS 6-<12 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
747223|NCT00076999|P3|Participant Flow|TPV OS 12-18 Yrs|Tipranavir Oral Solution (TPV OS), ages 12-18
747224|NCT00076999|P2|Participant Flow|TPV OS 6-<12 Yrs|Tipranavir Oral Solution (TPV OS), ages 6-11
747225|NCT00076999|P1|Participant Flow|TPV OS 2-<6 Yrs|Tipranavir Oral Solution (TPV OS), ages 2-5
747226|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747227|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
747228|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747229|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747230|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747231|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747232|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
747233|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747234|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747235|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747236|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747237|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747238|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747239|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747240|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747241|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747242|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747243|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747244|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747245|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747246|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747247|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747248|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747249|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747250|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747251|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747252|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747253|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747254|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747255|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747256|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747257|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747258|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747259|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747260|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747261|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747262|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747263|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747264|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747265|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747266|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747267|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747268|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747269|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747270|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747271|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747272|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747273|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747274|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747275|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747276|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747277|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747278|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747279|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747280|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747281|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747282|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747283|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747284|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747285|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747286|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747287|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747288|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747289|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747290|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747291|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747292|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747293|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747294|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747295|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747296|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747297|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747298|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747299|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747300|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747301|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747302|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747303|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747304|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747305|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747306|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747307|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747308|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747309|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747310|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747311|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747312|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747313|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747314|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747315|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747316|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747317|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747318|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747319|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747320|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747321|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747322|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747323|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747324|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747325|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747326|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747327|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747328|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747329|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747330|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747331|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747332|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747333|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747334|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747335|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747336|NCT00076999|E5|Reported Event|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
747337|NCT00076999|E4|Reported Event|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
747338|NCT00076999|E3|Reported Event|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
747339|NCT00076999|E2|Reported Event|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
747340|NCT00076999|E1|Reported Event|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
747341|NCT00003222|B3|Baseline|Total|Total of all reporting groups
747342|NCT00003222|B2|Baseline|Peptides in GMCSF-in-adjuvant|
747343|NCT00003222|B1|Baseline|Peptides Pulsed on Dendritic Cells|
747344|NCT00003222|P2|Participant Flow|Peptides in Sargramostim (GMCSF)-In-Montanide ISA-51 Adjuvant|---Peptides were administered in an emulsion of sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's) adjuvant
747345|NCT00003222|P1|Participant Flow|Peptides Pulsed on Dendritic Cells|---peptides were pulsed on monocyte-derived dendritic cells cultures in GM-CSF and IL-4
747346|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
747347|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
747348|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
747349|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
747350|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
747351|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
747352|NCT00003222|E2|Reported Event|Peptides in GMCSF-in-adjuvant|
747353|NCT00003222|E1|Reported Event|Peptides Pulsed on Dendritic Cells|
747354|NCT00076804|B3|Baseline|Total|Total of all reporting groups
747355|NCT00076804|B2|Baseline|Self Administration|Self administration of ARVs
747356|NCT00076804|B1|Baseline|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
747357|NCT00076804|P2|Participant Flow|Self Administration|Self administration of ARVs
747358|NCT00076804|P1|Participant Flow|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
747359|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
747360|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
747361|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
747362|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
747363|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
747364|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
747365|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
747366|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
747367|NCT00076804|E2|Reported Event|Self Administration|Self administration of ARVs
747368|NCT00076804|E1|Reported Event|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
747369|NCT00076752|B1|Baseline|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747370|NCT00076752|P1|Participant Flow|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
747371|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747372|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747373|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747374|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747375|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747376|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747377|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747378|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747379|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747380|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747381|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747382|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747383|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747384|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747385|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
747386|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
747387|NCT00076752|E1|Reported Event|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
747388|NCT00076622|B5|Baseline|Total|Total of all reporting groups
747389|NCT00076622|B4|Baseline|Participant Preference to Discontinue Drug|"Chose to stop antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747650|NCT00075803|P2|Participant Flow|Voriconazole|voriconazole prophylaxis
747390|NCT00076622|B3|Baseline|Participant Preference to Continue Drug|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747391|NCT00076622|B2|Baseline|Randomized to Drug Discontinuation|"Participants assigned to discontinue current antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747392|NCT00076622|B1|Baseline|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747393|NCT00076622|P4|Participant Flow|Participant Preference to Discontinue Drug|"Chose to stop antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747394|NCT00076622|P3|Participant Flow|Participant Preference to Continue Drug|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747395|NCT00076622|P2|Participant Flow|Randomized to Drug Discontinuation|"Participants assigned to discontinue current antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747396|NCT00076622|P1|Participant Flow|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747397|NCT00076622|O4|Outcome|Participant Preference to Discontinue Drug|"Chose to discontinue antidepressant medication (no antidepressant medication)~No antidepressant medication: Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms."
747398|NCT00076622|O3|Outcome|Participant Preference to Continue Drug|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747399|NCT00076622|O2|Outcome|Randomized to Drug Discontinuation|"Participants assigned to discontinue current antidepressant medication (no antidepressant medication)~No antidepressant medication: Participants assigned to discontinue current medication (no antidepressant medication) will be monitored over a period of one year for recurrence of depression and related symptoms."
747400|NCT00076622|O1|Outcome|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747401|NCT00076622|O4|Outcome|Non-Randomized Preference-discontinue|Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
747402|NCT00076622|O3|Outcome|Non Randomized/Preference Arm-continue|Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.
747403|NCT00076622|O2|Outcome|Randomized Arm-discontinue|Those who were randomized to discontinue anti depressants
747404|NCT00076622|O1|Outcome|Randomized Arm-continue|Participants who agreed to be randomized were assigned to the continuation antidepressant
747405|NCT00076622|O4|Outcome|Non-Randomized Preference-discontinue|Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
747406|NCT00076622|O3|Outcome|Non Randomized/Preference Arm-continue|Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.
747407|NCT00076622|O2|Outcome|Randomized Arm-discontinue|Those who were randomized to discontinue anti depressants
747408|NCT00076622|O1|Outcome|Randomized Arm-continue|Participants who agreed to be randomized were assigned to the continuation antidepressant
747409|NCT00076622|E4|Reported Event|Participation Based Upon Preference (Discontinue)|"Chose to stop antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747410|NCT00076622|E3|Reported Event|Participation Based Upon Preference (Continue)|"Chose to continue antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747411|NCT00076622|E2|Reported Event|Randomized to Discontinuation|"Participants assigned to discontinue current antidepressant medication~No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747412|NCT00076622|E1|Reported Event|Randomized to Drug Continuation|"Participants assigned to continue current antidepressant medication~Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms."
747413|NCT00076570|B3|Baseline|Total|Total of all reporting groups
747414|NCT00076570|B2|Baseline|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
747415|NCT00076570|B1|Baseline|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
747416|NCT00076570|P2|Participant Flow|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
747417|NCT00076570|P1|Participant Flow|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
747651|NCT00075803|P1|Participant Flow|Fluconazole|fluconazole prophylaxis
747418|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
747419|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
747420|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
747421|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
747422|NCT00076570|E2|Reported Event|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
747423|NCT00076570|E1|Reported Event|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
747424|NCT00003298|B1|Baseline|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
747425|NCT00003298|P1|Participant Flow|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
747426|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
747427|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
747428|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
747429|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
747430|NCT00003298|E2|Reported Event|Step 2 (Adjuvant Therapy)|After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
747431|NCT00003298|E1|Reported Event|Step 1(Neoadjuvant Therapy)|Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.
747432|NCT00076336|B3|Baseline|Total|Total of all reporting groups
747433|NCT00076336|B2|Baseline|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747434|NCT00076336|B1|Baseline|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747435|NCT00076336|P2|Participant Flow|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747436|NCT00076336|P1|Participant Flow|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747437|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747438|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747439|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747440|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747441|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747442|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747443|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747444|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747445|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747446|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747447|NCT00076336|E2|Reported Event|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747448|NCT00076336|E1|Reported Event|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
747449|NCT00076258|B3|Baseline|Total|Total of all reporting groups
747450|NCT00076258|B2|Baseline|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747451|NCT00076258|B1|Baseline|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747452|NCT00076258|P2|Participant Flow|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747453|NCT00076258|P1|Participant Flow|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747454|NCT00076258|O2|Outcome|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747455|NCT00076258|O1|Outcome|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747487|NCT00076219|E1|Reported Event|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
747646|NCT00075816|E1|Reported Event|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747456|NCT00076258|E2|Reported Event|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747457|NCT00076258|E1|Reported Event|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
747458|NCT00076245|B5|Baseline|Total|Total of all reporting groups
747459|NCT00076245|B4|Baseline|4 Control|
747460|NCT00076245|B3|Baseline|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
747461|NCT00076245|B2|Baseline|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
747462|NCT00076245|B1|Baseline|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
747463|NCT00076245|P4|Participant Flow|4 Control|
747464|NCT00076245|P3|Participant Flow|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
747465|NCT00076245|P2|Participant Flow|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
747466|NCT00076245|P1|Participant Flow|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
747467|NCT00076245|O4|Outcome|4 Control|
747468|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
747469|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
747470|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
747471|NCT00076245|O4|Outcome|4 Control|
747472|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
747473|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
747474|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
747475|NCT00076245|E4|Reported Event|4 Control|
747476|NCT00076245|E3|Reported Event|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
747477|NCT00076245|E2|Reported Event|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
747478|NCT00076245|E1|Reported Event|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
747479|NCT00076219|B3|Baseline|Total|Total of all reporting groups
747480|NCT00076219|B2|Baseline|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
747481|NCT00076219|B1|Baseline|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
747482|NCT00076219|P2|Participant Flow|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
747483|NCT00076219|P1|Participant Flow|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
747484|NCT00076219|O2|Outcome|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
747485|NCT00076219|O1|Outcome|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
747486|NCT00076219|E2|Reported Event|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
747488|NCT00076102|B1|Baseline|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747489|NCT00076102|P1|Participant Flow|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747490|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747491|NCT00076102|O1|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m^2/day).
747492|NCT00076102|O1|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747493|NCT00076102|O1|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747494|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747495|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747496|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747497|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747498|NCT00076102|O1|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747499|NCT00076102|E1|Reported Event|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
747500|NCT00076050|B3|Baseline|Total|Total of all reporting groups
747501|NCT00076050|B2|Baseline|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
747502|NCT00076050|B1|Baseline|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
747503|NCT00076050|P2|Participant Flow|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
747504|NCT00076050|P1|Participant Flow|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
747505|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
747506|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
747507|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
747508|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
747509|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
747510|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
747511|NCT00076050|E2|Reported Event|Placebo|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
747512|NCT00076050|E1|Reported Event|Soy Isoflavones|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
747513|NCT00076024|B4|Baseline|Total|Total of all reporting groups
747514|NCT00076024|B3|Baseline|Docetaxel + Placebo (Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued with axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
747515|NCT00076024|B2|Baseline|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
747594|NCT00075829|O2|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747516|NCT00076024|B1|Baseline|Axitinib + Docetaxel (Phase 1, Lead-in)|Axitinib (AG-013736) 5 mg tablet orally twice daily BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
747517|NCT00076024|P4|Participant Flow|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
747518|NCT00076024|P3|Participant Flow|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
747519|NCT00076024|P2|Participant Flow|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
747520|NCT00076024|P1|Participant Flow|Axitinib + Docetaxel (Phase-1, Lead-in)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 milligram/square meter (mg/m^2) 1 hour (hr) intravenous (IV) infusion on Day 1 of each cycle, in cycles of 3 weeks.
747521|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
747522|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
747523|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
747524|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
747525|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
747526|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
747527|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
747528|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
747529|NCT00076024|E4|Reported Event|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
747530|NCT00076024|E3|Reported Event|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
747531|NCT00076024|E2|Reported Event|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
747532|NCT00076024|E1|Reported Event|Axitinib + Docetaxel (Phase-1 Lead-in)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
747533|NCT00076011|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747534|NCT00076011|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747535|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747536|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747537|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747538|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747595|NCT00075829|O1|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
747539|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747540|NCT00076011|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
747541|NCT00075946|B5|Baseline|Total|Total of all reporting groups
747542|NCT00075946|B4|Baseline|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747543|NCT00075946|B3|Baseline|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747544|NCT00075946|B2|Baseline|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747545|NCT00075946|B1|Baseline|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747546|NCT00075946|P5|Participant Flow|Enrolled But Not Randomized|Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
747547|NCT00075946|P4|Participant Flow|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747548|NCT00075946|P3|Participant Flow|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747549|NCT00075946|P2|Participant Flow|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747550|NCT00075946|P1|Participant Flow|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747551|NCT00075946|O2|Outcome|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
747552|NCT00075946|O1|Outcome|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
747553|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747554|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747555|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747556|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747557|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747558|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747559|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
747560|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
747561|NCT00075946|E3|Reported Event|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
747647|NCT00075803|B3|Baseline|Total|Total of all reporting groups
747562|NCT00075946|E2|Reported Event|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
747563|NCT00075946|E1|Reported Event|Arm I: Induction Rituximab|Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
747564|NCT00075881|B1|Baseline|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
747565|NCT00075881|P1|Participant Flow|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
747566|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
747567|NCT00075881|O1|Outcome|PS-341|Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose
747568|NCT00075881|O1|Outcome|PS-341|Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
747569|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
747570|NCT00075881|E1|Reported Event|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
747571|NCT00075829|B5|Baseline|Total|Total of all reporting groups
747572|NCT00075829|B4|Baseline|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747573|NCT00075829|B3|Baseline|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
747574|NCT00075829|B2|Baseline|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747575|NCT00075829|B1|Baseline|Auto-Auto Standard Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
747576|NCT00075829|P4|Participant Flow|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747577|NCT00075829|P3|Participant Flow|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
747578|NCT00075829|P2|Participant Flow|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747579|NCT00075829|P1|Participant Flow|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
747580|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747581|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747582|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747583|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
747584|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747585|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
747586|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747587|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
747588|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747589|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
747590|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747591|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
747592|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747593|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
747596|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747597|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
747598|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747599|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
747600|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747601|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
747602|NCT00075829|E4|Reported Event|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
747603|NCT00075829|E3|Reported Event|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
747604|NCT00075829|E2|Reported Event|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
747605|NCT00075829|E1|Reported Event|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
747606|NCT00075816|B3|Baseline|Total|Total of all reporting groups
747607|NCT00075816|B2|Baseline|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747608|NCT00075816|B1|Baseline|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747609|NCT00075816|P2|Participant Flow|Peripheral-Blood Stem Cells|Patients who underwent transplantation of peripheral-blood stem cells from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
747610|NCT00075816|P1|Participant Flow|Bone Marrow|Patients who underwent transplantation of bone marrow from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
747611|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
747612|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
747613|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747614|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747615|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747616|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747617|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747618|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747619|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
747620|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
747621|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
747622|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
747623|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747624|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747625|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747626|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747627|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747628|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747629|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747630|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747631|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747632|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747633|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747634|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747635|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
747636|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
747637|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747638|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747639|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747640|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747641|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747642|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747643|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747644|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
747645|NCT00075816|E2|Reported Event|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
747648|NCT00075803|B2|Baseline|Voriconazole|voriconazole prophylaxis
747677|NCT00075764|B2|Baseline|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
747678|NCT00075764|B1|Baseline|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
747679|NCT00075764|P2|Participant Flow|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
747680|NCT00075764|P1|Participant Flow|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
747681|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
747682|NCT00075764|O1|Outcome|Arm I Anastrozole|Patients receive oral anastrozole once daily on days 1-28
747683|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
747684|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
747685|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
747686|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
747687|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
747688|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
747689|NCT00075764|E2|Reported Event|Anastrozole & Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
747690|NCT00075764|E1|Reported Event|Anastrozole|Patients receive oral anastrozole once daily on days 1-28
747691|NCT00075725|B13|Baseline|Total|Total of all reporting groups
747692|NCT00075725|B12|Baseline|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
747693|NCT00075725|B11|Baseline|Dexamethasone, Capizzi Methotrexate Down Syndrome|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747694|NCT00075725|B10|Baseline|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747695|NCT00075725|B9|Baseline|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747696|NCT00075725|B8|Baseline|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
748751|NCT00070941|O3|Outcome|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
747697|NCT00075725|B7|Baseline|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747698|NCT00075725|B6|Baseline|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747699|NCT00075725|B5|Baseline|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747700|NCT00075725|B4|Baseline|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747701|NCT00075725|B3|Baseline|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747702|NCT00075725|B2|Baseline|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747703|NCT00075725|B1|Baseline|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747704|NCT00075725|P12|Participant Flow|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747705|NCT00075725|P11|Participant Flow|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747856|NCT00075400|B1|Baseline|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747706|NCT00075725|P10|Participant Flow|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747707|NCT00075725|P9|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747708|NCT00075725|P8|Participant Flow|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747709|NCT00075725|P7|Participant Flow|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH (Prednisone, High Dose MTX) regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747710|NCT00075725|P6|Participant Flow|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747711|NCT00075725|P5|Participant Flow|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC (Prednisone, Capizzi) will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747712|NCT00075725|P4|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747713|NCT00075725|P3|Participant Flow|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747714|NCT00075725|P2|Participant Flow|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH (High Dose) regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747984|NCT00074984|B2|Baseline|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
747715|NCT00075725|P1|Participant Flow|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747716|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747717|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747718|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747719|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747720|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747721|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747722|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747723|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747857|NCT00075400|P1|Participant Flow|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747985|NCT00074984|B1|Baseline|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
748752|NCT00070941|O2|Outcome|Escitalopram|oral Escitalopram 10mg or 20m
747724|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747725|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747726|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747727|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747728|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747729|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747730|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747731|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747732|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747858|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747733|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747734|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747735|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747736|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747737|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747738|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747739|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747740|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747741|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
748753|NCT00070941|O1|Outcome|SAM-e|SAM-e, 1200mg or 2400 mg
747742|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747743|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747744|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747745|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747746|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747747|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747748|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747749|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747750|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747859|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747986|NCT00074984|P2|Participant Flow|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
747751|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747752|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747753|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747754|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747755|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747756|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747757|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747758|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747759|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747860|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747760|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747761|NCT00075725|O10|Outcome|Prednisone, Capizzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747762|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747763|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747764|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747765|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747766|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747767|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747768|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747861|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747987|NCT00074984|P1|Participant Flow|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
747769|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747770|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747771|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747772|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747773|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747774|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747775|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747776|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747777|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747862|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747778|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747779|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747780|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747781|NCT00075725|O10|Outcome|Prenisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747782|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747783|NCT00075725|O8|Outcome|Prenisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747784|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747785|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747786|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747863|NCT00075400|O5|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
747864|NCT00075400|O4|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
747865|NCT00075400|O3|Outcome|Grade 2 (CTCAE v 3.0)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
748109|NCT00074269|O1|Outcome|Treatment|Patients Treated Per Protocol
747787|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747788|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747789|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747790|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747791|NCT00075725|E12|Reported Event|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747792|NCT00075725|E11|Reported Event|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747793|NCT00075725|E10|Reported Event|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747794|NCT00075725|E9|Reported Event|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747795|NCT00075725|E8|Reported Event|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747796|NCT00075725|E7|Reported Event|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747797|NCT00075725|E6|Reported Event|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747798|NCT00075725|E5|Reported Event|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
747799|NCT00075725|E4|Reported Event|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747800|NCT00075725|E3|Reported Event|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747801|NCT00075725|E2|Reported Event|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747802|NCT00075725|E1|Reported Event|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
747803|NCT00075608|B1|Baseline|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
747804|NCT00075608|P1|Participant Flow|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
747805|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
747806|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
747807|NCT00075608|O1|Outcome|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
747808|NCT00075608|E1|Reported Event|Second Transplant|Participants who received a second transplant
747809|NCT00075582|B3|Baseline|Total|Total of all reporting groups
747866|NCT00075400|O2|Outcome|Grade 1 (CTCAE v 3.0)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
747867|NCT00075400|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
748110|NCT00074269|O1|Outcome|Treatment|Patients treated on protocol
747810|NCT00075582|B2|Baseline|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747811|NCT00075582|B1|Baseline|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747812|NCT00075582|P2|Participant Flow|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747813|NCT00075582|P1|Participant Flow|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747814|NCT00075582|O1|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747815|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747816|NCT00075582|O2|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747817|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747818|NCT00075582|E2|Reported Event|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747868|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
748147|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
747819|NCT00075582|E1|Reported Event|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
747820|NCT00075504|B3|Baseline|Total|Total of all reporting groups
747821|NCT00075504|B2|Baseline|Stratum B Abnormal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747822|NCT00075504|B1|Baseline|Stratum A Normal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747823|NCT00075504|P2|Participant Flow|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747824|NCT00075504|P1|Participant Flow|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747825|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747826|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747827|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747828|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747829|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747830|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747831|NCT00075504|E2|Reported Event|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747832|NCT00075504|E1|Reported Event|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
747833|NCT00075478|B3|Baseline|Total|Total of all reporting groups
747834|NCT00075478|B2|Baseline|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747835|NCT00075478|B1|Baseline|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747836|NCT00075478|P2|Participant Flow|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747837|NCT00075478|P1|Participant Flow|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747978|NCT00075023|O2|Outcome|Placebo|Placebo Gel
747979|NCT00075023|O1|Outcome|Thalidomide Gel|Thalidomide Gel
748148|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
747838|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747839|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747840|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747841|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747842|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747843|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747844|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747845|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747846|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
748149|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
747847|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747848|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747849|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747850|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747851|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747852|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747853|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747854|NCT00075478|E2|Reported Event|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747855|NCT00075478|E1|Reported Event|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
747869|NCT00075400|E1|Reported Event|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
747870|NCT00075335|B1|Baseline|AMD 3100 (Mozobil Plerixafor ) Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
747871|NCT00075335|P1|Participant Flow|AMD 3100 (Mozobil Plerixafor ) Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers. AMD 3100 volunteer response to peripheral blood stem cell mobilization
747872|NCT00075335|O1|Outcome|AMD 3100 Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
747873|NCT00075335|O1|Outcome|AMD 3100 Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
747874|NCT00075335|E1|Reported Event|AMD 3100 (Mozobil Plerixafor ) Volunteers|Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
747875|NCT00075270|B3|Baseline|Total|Total of all reporting groups
747876|NCT00075270|B2|Baseline|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747877|NCT00075270|B1|Baseline|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747878|NCT00075270|P2|Participant Flow|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747879|NCT00075270|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747880|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747881|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747882|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747883|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747884|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747885|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747886|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747887|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747888|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747889|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747890|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747891|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747892|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747893|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747894|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747895|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747896|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747897|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747898|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747899|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747900|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747901|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747902|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747903|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747904|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747905|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747906|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747907|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747908|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747909|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747910|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747911|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747980|NCT00075023|E3|Reported Event|Adverse Events for All Participants|These are adverse events for participants as reported to the DSMB, without information related to treatment arm
747912|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747913|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747914|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747915|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747916|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747917|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747918|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747919|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747920|NCT00075270|E2|Reported Event|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747921|NCT00075270|E1|Reported Event|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
747922|NCT00075218|B3|Baseline|Total|Total of all reporting groups
747923|NCT00075218|B2|Baseline|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747924|NCT00075218|B1|Baseline|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747925|NCT00075218|P3|Participant Flow|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
747926|NCT00075218|P2|Participant Flow|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747927|NCT00075218|P1|Participant Flow|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747928|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747929|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747930|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747981|NCT00075023|E2|Reported Event|Placebo|Placebo Gel
747982|NCT00075023|E1|Reported Event|Thalidomide Gel|Thalidomide Gel
747983|NCT00074984|B3|Baseline|Total|Total of all reporting groups
747931|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747932|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747933|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747934|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747935|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747936|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747937|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747938|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747939|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747940|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747941|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747942|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747943|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747944|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747945|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747946|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747947|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747948|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747949|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747950|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747951|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747952|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747953|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747954|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747955|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747956|NCT00075218|E3|Reported Event|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
747957|NCT00075218|E2|Reported Event|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
747958|NCT00075218|E1|Reported Event|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
747959|NCT00075088|B3|Baseline|Total|Total of all reporting groups
747960|NCT00075088|B2|Baseline|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
747961|NCT00075088|B1|Baseline|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
747962|NCT00075088|P2|Participant Flow|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
747963|NCT00075088|P1|Participant Flow|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
747964|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
747965|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
747966|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
747967|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
747968|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
747969|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
747970|NCT00075088|E3|Reported Event|Prehospital|"At the start of the trial, the IRB requested every death in the pre-hospital period be reported because we put on the study electrocardiogram device in the field with waiver of consent so as not to cause a delay for patients reaching the hospital with possible heart attack. They were consented after they reached the hospital. However, IRB removed this requirement after 40 pre-consent/pre-hospital deaths were reported. The number of pre-hospital participants assessed before and after the IRB changed the reporting requirements cannot be determined from study data, but NA is not a valid entry in the At Risk field."
747971|NCT00075088|E2|Reported Event|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
747972|NCT00075088|E1|Reported Event|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
747973|NCT00075023|B3|Baseline|Total|Total of all reporting groups
747974|NCT00075023|B2|Baseline|Placebo|Placebo Gel
747975|NCT00075023|B1|Baseline|Thalidomide Gel|Thalidomide Gel
747976|NCT00075023|P2|Participant Flow|Placebo|Placebo Gel
747977|NCT00075023|P1|Participant Flow|Thalidomide Gel|Thalidomide Gel
747988|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
747989|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
747990|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
747991|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
747992|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
747993|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
747994|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
747995|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
747996|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
747997|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
747998|NCT00074984|E3|Reported Event|Total|All patients.
747999|NCT00074984|E2|Reported Event|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks
748000|NCT00074984|E1|Reported Event|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme(agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
748001|NCT00074958|B1|Baseline|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
748002|NCT00074958|P1|Participant Flow|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
748003|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
748004|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
748005|NCT00074958|E1|Reported Event|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
748006|NCT00074815|B4|Baseline|Total|Total of all reporting groups
748007|NCT00074815|B3|Baseline|MM Only|Participants will receive medication management only
748008|NCT00074815|B2|Baseline|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
748009|NCT00074815|B1|Baseline|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
748010|NCT00074815|P3|Participant Flow|MM Only|Participants will receive medication management only
748011|NCT00074815|P2|Participant Flow|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
748012|NCT00074815|P1|Participant Flow|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
748013|NCT00074815|O3|Outcome|MM Only|Participants will receive medication management only
748014|NCT00074815|O2|Outcome|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
748015|NCT00074815|O1|Outcome|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
748016|NCT00074815|E3|Reported Event|MM Only|Participants will receive medication management only
748017|NCT00074815|E2|Reported Event|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
748018|NCT00074815|E1|Reported Event|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
748019|NCT00074802|B3|Baseline|Total|Total of all reporting groups
748020|NCT00074802|B2|Baseline|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748021|NCT00074802|B1|Baseline|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748022|NCT00074802|P2|Participant Flow|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748023|NCT00074802|P1|Participant Flow|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748024|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748025|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748026|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748150|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
748027|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748028|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748029|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748030|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748031|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748032|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748033|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748034|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748035|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748036|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748037|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748038|NCT00074802|E2|Reported Event|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
748039|NCT00074802|E1|Reported Event|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
748040|NCT00074711|B3|Baseline|Total|Total of all reporting groups
748041|NCT00074711|B2|Baseline|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748042|NCT00074711|B1|Baseline|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748043|NCT00074711|P2|Participant Flow|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748044|NCT00074711|P1|Participant Flow|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748045|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748046|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748047|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748048|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748049|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748050|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748051|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748151|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
748052|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748053|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748054|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748055|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748056|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748057|NCT00074711|E2|Reported Event|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
748058|NCT00074711|E1|Reported Event|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
748059|NCT00074581|B3|Baseline|Total|Total of all reporting groups
748060|NCT00074581|B2|Baseline|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
748061|NCT00074581|B1|Baseline|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
748062|NCT00074581|P2|Participant Flow|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
748063|NCT00074581|P1|Participant Flow|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
748064|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
748065|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
748066|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
748067|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
748068|NCT00074581|E2|Reported Event|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
748069|NCT00074581|E1|Reported Event|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
748070|NCT00074412|B3|Baseline|Total|Total of all reporting groups
748071|NCT00074412|B2|Baseline|Placebo|For infants: extended treatment with NVP placebo
748072|NCT00074412|B1|Baseline|Nevirapine|For infants: extended treatment with NVP
748073|NCT00074412|P2|Participant Flow|Nevirapine|For infants: extended treatment with NVP
748074|NCT00074412|P1|Participant Flow|Placebo|For infants: extended treatment with NVP placebo
748075|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
748076|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
748077|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
748078|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
748079|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
748080|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
748081|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
748082|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
748083|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP Placebo
748084|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
748085|NCT00074412|E2|Reported Event|Placebo|For infants: extended treatment with NVP placebo
748086|NCT00074412|E1|Reported Event|Nevirapine|For infants: extended treatment with NVP
748087|NCT00074308|B3|Baseline|Total|Total of all reporting groups
748088|NCT00074308|B2|Baseline|Phase 2|Patients receive oral imatinib mesylate once or twice daily (400 mg/day) on days 1-28 and bevacizumab IV (10mg/kg) over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptance toxicity.
748089|NCT00074308|B1|Baseline|Phase 1|Patients receive oral imatinib mesylate once or twice daily (400-800 mg/day) on days 1-28 and bevacizumab IV (5-10mg/kg) over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
748090|NCT00074308|P5|Participant Flow|Phase 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
748091|NCT00074308|P4|Participant Flow|Phase 1 Dose 4|Bevacizumab (10 mg/kg) Imatinib (800 mg/day)
748092|NCT00074308|P3|Participant Flow|Phase 1 Dose 3|Bevacizumab (10 mg/kg) Imatinib (600 mg/day)
748093|NCT00074308|P2|Participant Flow|Phase 1 Dose 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
748094|NCT00074308|P1|Participant Flow|Phase 1 - Dose 1|Bevacizumab (5 mg/kg) Imatinib (400 mg/day)
748095|NCT00074308|O1|Outcome|Phase 2 = Dose Expansion|"Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~bevacizumab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
748096|NCT00074308|O1|Outcome|Phase 2 = Dose Expansion|"Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~bevacizumab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
748097|NCT00074308|O1|Outcome|Phase 1 = Dose Escalation|"Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~bevacizumab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
748098|NCT00074308|E5|Reported Event|Phase 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
748099|NCT00074308|E4|Reported Event|Phase 1 Dose 4|Bevacizumab (10 mg/kg) Imatinib (800 mg/day)
748100|NCT00074308|E3|Reported Event|Phase 1 Dose 3|Bevacizumab (10 mg/kg) Imatinib (600 mg/day)
748101|NCT00074308|E2|Reported Event|Phase 1 Dose 2|Bevacizumab (10 mg/kg) Imatinib (400 mg/day)
748102|NCT00074308|E1|Reported Event|Phase 1 - Dose 1|Bevacizumab (5 mg/kg) Imatinib (400 mg/day)
748103|NCT00074269|B1|Baseline|Pilot Study of Allogeneic Transplant for Metastatic Breast Can|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
748104|NCT00074269|P1|Participant Flow|Treatment|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
748105|NCT00074269|O1|Outcome|Treatment|Patients treated on protocol
748106|NCT00074269|O1|Outcome|Treatment|Patients treated on protocol
748107|NCT00074269|O1|Outcome|Treatment|patients treated on protocol
748108|NCT00074269|O1|Outcome|Treatment|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
748111|NCT00074269|O1|Outcome|Treatment|"Toxicity~anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
748112|NCT00074269|E1|Reported Event|Treatment|"The events monitored in the treatment arm of the protocol are listed below:~incidence of Toxicity~administration of filgrastim~Grade of GVHD~Initiation of graft-versus-tumor induction therapy~Disease Status"
748113|NCT00074165|B1|Baseline|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
748114|NCT00074165|P1|Participant Flow|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
748115|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
748116|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
748117|NCT00074165|E1|Reported Event|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
748118|NCT00074152|B3|Baseline|Total|Total of all reporting groups
748119|NCT00074152|B2|Baseline|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
748120|NCT00074152|B1|Baseline|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
748121|NCT00074152|P2|Participant Flow|Chemotherapy|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
748122|NCT00074152|P1|Participant Flow|Observation|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
748123|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
748124|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
748125|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
748126|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
748127|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
748128|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
748129|NCT00074152|E2|Reported Event|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
748130|NCT00074152|E1|Reported Event|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
748131|NCT00074035|B1|Baseline|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
748132|NCT00074035|P1|Participant Flow|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
748133|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
748134|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
748135|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
748136|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
748137|NCT00074035|E1|Reported Event|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
748138|NCT00073983|B1|Baseline|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
748139|NCT00073983|P1|Participant Flow|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
748140|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
748141|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
748142|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
748143|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
748144|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
748145|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
748146|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
748152|NCT00073983|E1|Reported Event|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
748153|NCT00073957|B1|Baseline|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
748154|NCT00073957|P1|Participant Flow|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
748155|NCT00073957|O1|Outcome|Yttrium Y 90 Ibritumomab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
748156|NCT00073957|O1|Outcome|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Y 90 Ibritumomab Tiuxetan and Rituximab
748157|NCT00073957|O1|Outcome|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
748158|NCT00073957|E1|Reported Event|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab|Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
748159|NCT00073918|B1|Baseline|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
748160|NCT00073918|P1|Participant Flow|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
748161|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
748162|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
748163|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
748164|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
748165|NCT00073918|E1|Reported Event|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
748166|NCT00073528|B3|Baseline|Total|Total of all reporting groups
748167|NCT00073528|B2|Baseline|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748168|NCT00073528|B1|Baseline|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748169|NCT00073528|P2|Participant Flow|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748170|NCT00073528|P1|Participant Flow|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748171|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748172|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748173|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748174|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748175|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748176|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748177|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748178|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748179|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748180|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748181|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748182|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748183|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748184|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748185|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748186|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748187|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748188|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748189|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748190|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748191|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748192|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748193|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748194|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748195|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748196|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748197|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748198|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748199|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748200|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748201|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748202|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748203|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748204|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748205|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748206|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748207|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748208|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748209|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748210|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748211|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748212|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748213|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748214|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748215|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748216|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748217|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748218|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748219|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748220|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748221|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748222|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748223|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748224|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748225|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748226|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748227|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748228|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748229|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748230|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748231|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748232|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748233|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748234|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748235|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748236|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748237|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748238|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748239|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748240|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748241|NCT00073528|E2|Reported Event|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748242|NCT00073528|E1|Reported Event|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
748243|NCT00073333|B4|Baseline|Total|Total of all reporting groups
748244|NCT00073333|B3|Baseline|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
748245|NCT00073333|B2|Baseline|2Imaginal and in Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
748246|NCT00073333|B1|Baseline|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
748247|NCT00073333|P3|Participant Flow|3Attention Placebo|Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact
748248|NCT00073333|P2|Participant Flow|2Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice
748249|NCT00073333|P1|Participant Flow|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly.
748250|NCT00073333|O3|Outcome|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
748251|NCT00073333|O2|Outcome|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
748252|NCT00073333|O1|Outcome|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
748253|NCT00073333|E3|Reported Event|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
748254|NCT00073333|E2|Reported Event|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
748255|NCT00073333|E1|Reported Event|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
748256|NCT00073307|B3|Baseline|Total|Total of all reporting groups
748257|NCT00073307|B2|Baseline|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
748258|NCT00073307|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
748864|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Standard dose imatinib A
748259|NCT00073307|P3|Participant Flow|Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only|Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).
748260|NCT00073307|P2|Participant Flow|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
748261|NCT00073307|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
748262|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
748263|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
748264|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
748265|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
748266|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
748267|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
748268|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
748269|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
748270|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
748271|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
748272|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
748273|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
748274|NCT00073307|E4|Reported Event|Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008|Sorafenib period only-30Jun2008: Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily). Open Label/Sorafenib only period-30Jun2008
748275|NCT00073307|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006)-30Jun2008|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind-30Jun2008. In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the open-label/Sorafenib only phase and was included in the safety population only. Participants affected may deviate from double-blind phase due to data update and cleaning.
748276|NCT00073307|E2|Reported Event|Placebo-31May2005 DB|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
748277|NCT00073307|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)-31May2005 DB|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind period-31May2005
748278|NCT00073073|B1|Baseline|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748279|NCT00073073|P1|Participant Flow|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748280|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748281|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748282|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748283|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748315|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748284|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748285|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748286|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748287|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748288|NCT00073073|E1|Reported Event|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
748289|NCT00073021|B3|Baseline|Total|Total of all reporting groups
748290|NCT00073021|B2|Baseline|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748291|NCT00073021|B1|Baseline|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748292|NCT00073021|P2|Participant Flow|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748293|NCT00073021|P1|Participant Flow|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748294|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748295|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748296|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748297|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748298|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748299|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748300|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748301|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748302|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748303|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748304|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748305|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748306|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748307|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748308|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748309|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748310|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748311|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748312|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748313|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748314|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748316|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748317|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748318|NCT00073021|E2|Reported Event|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
748319|NCT00073021|E1|Reported Event|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
748320|NCT00073008|B3|Baseline|Total|Total of all reporting groups
748321|NCT00073008|B2|Baseline|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748322|NCT00073008|B1|Baseline|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748323|NCT00073008|P2|Participant Flow|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748324|NCT00073008|P1|Participant Flow|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748325|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748326|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748327|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748328|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748329|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748330|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748331|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748332|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748333|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748334|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748335|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748336|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748337|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748338|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748339|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748340|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748341|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748342|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748343|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748344|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748345|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748346|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748347|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748348|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748349|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748350|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748351|NCT00073008|E2|Reported Event|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
748352|NCT00073008|E1|Reported Event|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
748353|NCT00072761|B3|Baseline|Total|Total of all reporting groups
748354|NCT00072761|B2|Baseline|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
748355|NCT00072761|B1|Baseline|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
748356|NCT00072761|P2|Participant Flow|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
748357|NCT00072761|P1|Participant Flow|Transfusion Group|The transfusion group received blood transfusion therapy every 4-6 weeks for 36 months.
748358|NCT00072761|O2|Outcome|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
748359|NCT00072761|O1|Outcome|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
748360|NCT00072761|E2|Reported Event|Observation Group|The observation Group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
748361|NCT00072761|E1|Reported Event|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
748362|NCT00072475|B1|Baseline|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
748363|NCT00072475|P1|Participant Flow|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
748364|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
748365|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
748366|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
748463|NCT00071812|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748367|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
748368|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
748369|NCT00072475|E1|Reported Event|Vatalanib|After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
748370|NCT00072449|B1|Baseline|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
748371|NCT00072449|P1|Participant Flow|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
748372|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
748373|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
748374|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
748375|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
748376|NCT00072449|E1|Reported Event|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
748377|NCT00072293|B3|Baseline|Total|Total of all reporting groups
748378|NCT00072293|B2|Baseline|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
748379|NCT00072293|B1|Baseline|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
748380|NCT00072293|P2|Participant Flow|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
748381|NCT00072293|P1|Participant Flow|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
748382|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
748383|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
748384|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
748385|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
748386|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
748387|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
748388|NCT00072293|E2|Reported Event|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
748389|NCT00072293|E1|Reported Event|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
748390|NCT00072280|B3|Baseline|Total|Total of all reporting groups
748391|NCT00072280|B2|Baseline|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
748392|NCT00072280|B1|Baseline|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
748393|NCT00072280|P2|Participant Flow|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
748394|NCT00072280|P1|Participant Flow|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
748464|NCT00071812|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748465|NCT00071812|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748395|NCT00072280|O1|Outcome|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
748396|NCT00072280|E2|Reported Event|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
748397|NCT00072280|E1|Reported Event|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
748398|NCT00072189|B1|Baseline|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
748399|NCT00072189|P1|Participant Flow|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
748400|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
748401|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
748402|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
748403|NCT00072189|E1|Reported Event|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
748404|NCT00072176|B3|Baseline|Total|Total of all reporting groups
748405|NCT00072176|B2|Baseline|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748406|NCT00072176|B1|Baseline|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748407|NCT00072176|P2|Participant Flow|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748408|NCT00072176|P1|Participant Flow|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748409|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748410|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748411|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748412|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748413|NCT00072176|E2|Reported Event|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748414|NCT00072176|E1|Reported Event|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
748415|NCT00071981|B5|Baseline|Total|Total of all reporting groups
748416|NCT00071981|B4|Baseline|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748417|NCT00071981|B3|Baseline|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748418|NCT00071981|B2|Baseline|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748419|NCT00071981|B1|Baseline|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748420|NCT00071981|P4|Participant Flow|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748421|NCT00071981|P3|Participant Flow|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748422|NCT00071981|P2|Participant Flow|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748423|NCT00071981|P1|Participant Flow|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748424|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748425|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748426|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748427|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748428|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748429|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748430|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748431|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748432|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748433|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748434|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748435|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748436|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748437|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748438|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748439|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748440|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748441|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748442|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748443|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748444|NCT00071981|E4|Reported Event|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748540|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748445|NCT00071981|E3|Reported Event|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
748446|NCT00071981|E2|Reported Event|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
748447|NCT00071981|E1|Reported Event|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
748448|NCT00072566|B1|Baseline|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
748449|NCT00072566|P1|Participant Flow|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
748450|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
748451|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
748452|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
748453|NCT00072566|E1|Reported Event|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
748454|NCT00072514|B1|Baseline|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
748455|NCT00072514|P1|Participant Flow|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
748456|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
748457|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
748458|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
748459|NCT00072514|O1|Outcome|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
748460|NCT00072514|E1|Reported Event|Treatment|Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
748461|NCT00071812|B5|Baseline|Total|Total of all reporting groups
748462|NCT00071812|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748466|NCT00071812|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 24-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
748467|NCT00071812|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
748468|NCT00071812|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
748469|NCT00071812|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study.
748470|NCT00071812|O5|Outcome|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
748471|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748472|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748473|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748474|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748475|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748476|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748477|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748478|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748479|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748480|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748481|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748482|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748483|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748484|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748485|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748486|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748487|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748488|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748489|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748490|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748491|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748492|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748493|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748494|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748495|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748496|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748497|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748498|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748499|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748500|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748501|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748502|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748541|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748503|NCT00071812|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double blind period and opted to continue in the 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
748504|NCT00071812|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748505|NCT00071812|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748506|NCT00071812|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748507|NCT00071812|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
748508|NCT00071799|B3|Baseline|Total|Total of all reporting groups
748509|NCT00071799|B2|Baseline|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748510|NCT00071799|B1|Baseline|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748511|NCT00071799|P2|Participant Flow|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748512|NCT00071799|P1|Participant Flow|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748513|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748514|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748515|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748516|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748517|NCT00071799|O4|Outcome|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles – 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
748518|NCT00071799|O3|Outcome|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
748519|NCT00071799|O2|Outcome|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
748520|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748521|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748522|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748523|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748524|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748525|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748526|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748527|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748528|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748529|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748530|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748531|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748532|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748533|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748534|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748535|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748536|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748537|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748538|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748539|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748977|NCT00069823|E2|Reported Event|Esomeprazole|40 mg of esomeprazole twice daily
748542|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748543|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748544|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748545|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
748546|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748547|NCT00071799|E4|Reported Event|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
748548|NCT00071799|E3|Reported Event|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
748549|NCT00071799|E2|Reported Event|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
748550|NCT00071799|E1|Reported Event|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
748551|NCT00071890|B3|Baseline|Total|Total of all reporting groups
748552|NCT00071890|B2|Baseline|Control Group|HAART alone (without Interleukin-2)
748553|NCT00071890|B1|Baseline|Interleukin-2 Group|HAART and tree cycles of IL-2
748554|NCT00071890|P2|Participant Flow|Control Group|HAART alone (without Interleukin-2)
748555|NCT00071890|P1|Participant Flow|Interleukin-2 Group|HAART and tree cycles of IL-2
748556|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
748557|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
748558|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
748559|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
748560|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
748561|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
748562|NCT00071890|E2|Reported Event|Control Group|HAART alone (without Interleukin-2)
748563|NCT00071890|E1|Reported Event|Interleukin-2 Group|HAART and tree cycles of IL-2
748564|NCT00071760|B1|Baseline|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748565|NCT00071760|P1|Participant Flow|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748566|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748567|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748568|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748636|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748637|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748569|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748570|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748571|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748572|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748573|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748574|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748575|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748576|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748577|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748578|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748638|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748678|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748579|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
748580|NCT00071760|O2|Outcome|ART-experienced, PI-naïve FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
748581|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
748582|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
748583|NCT00071760|O2|Outcome|PI-naïve, ART-experienced FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
748584|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
748585|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748586|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748639|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748587|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748588|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748589|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748590|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748591|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748592|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748593|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748594|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748595|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748596|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748614|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748748|NCT00070941|P3|Participant Flow|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
748597|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748598|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748599|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748600|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748601|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748602|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748603|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748615|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748604|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748605|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748606|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748607|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748608|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748609|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748610|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748611|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748612|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748613|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748616|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748617|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748618|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748619|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748620|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
748621|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748622|NCT00071760|E1|Reported Event|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
748623|NCT00071721|B3|Baseline|Total|Total of all reporting groups
748624|NCT00071721|B2|Baseline|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748625|NCT00071721|B1|Baseline|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748626|NCT00071721|P2|Participant Flow|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748627|NCT00071721|P1|Participant Flow|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748628|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748629|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748630|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748631|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748632|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748633|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748634|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748635|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748640|NCT00071721|E2|Reported Event|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
748641|NCT00071721|E1|Reported Event|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
748642|NCT00071513|B3|Baseline|Total|Total of all reporting groups
748643|NCT00071513|B2|Baseline|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
748644|NCT00071513|B1|Baseline|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
748645|NCT00071513|P2|Participant Flow|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
748646|NCT00071513|P1|Participant Flow|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTS leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
748647|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~Brief Intervention: Assessment of needs and referral to services as needed."
748648|NCT00071513|O1|Outcome|CAST-T/HSTS|"The CAST-T/HSTS condition combined the Brief Intervention and 12 school based small group sessions which taught skills to enhance personal control (to manage depression, anger, stress), self-esteem, decision making and interpersonal communications. HSTS skills groups were held in the spring of 8th grade with 4 one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents also participated in 4 sessions. HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST-T/HSTS: Skills training small group."
748649|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
748674|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748675|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748676|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748677|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748650|NCT00071513|O1|Outcome|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
748651|NCT00071513|E2|Reported Event|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
748652|NCT00071513|E1|Reported Event|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
748653|NCT00071487|B5|Baseline|Total|Total of all reporting groups
748654|NCT00071487|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748655|NCT00071487|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748656|NCT00071487|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748657|NCT00071487|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748658|NCT00071487|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 52-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
748659|NCT00071487|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
748660|NCT00071487|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
748661|NCT00071487|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748662|NCT00071487|O5|Outcome|Open-Label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to belimumab 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
748663|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748664|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748665|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748666|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748667|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748668|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748669|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748670|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748671|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748672|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748673|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748749|NCT00070941|P2|Participant Flow|Escitalopram|oral Escitalopram 10mg or 20m
748679|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748680|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748681|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748682|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748683|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748684|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748685|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748686|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748687|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748688|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748689|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748690|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748691|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748692|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748693|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748694|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748695|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748696|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748697|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748698|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
748699|NCT00071487|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
748700|NCT00071487|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
748701|NCT00071487|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
748702|NCT00071487|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
748703|NCT00071487|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
748704|NCT00071396|B1|Baseline|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
748705|NCT00071396|P1|Participant Flow|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
748706|NCT00071396|O1|Outcome|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
748707|NCT00071396|E1|Reported Event|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
748708|NCT00071110|B3|Baseline|Total|Total of all reporting groups
748709|NCT00071110|B2|Baseline|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
748710|NCT00071110|B1|Baseline|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
748711|NCT00071110|P2|Participant Flow|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
748712|NCT00071110|P1|Participant Flow|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
748713|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
748714|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
748715|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
748750|NCT00070941|P1|Participant Flow|SAM-e|SAM-e, 1200mg or 2400 mg
748716|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
748717|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
748718|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
748719|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
748720|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
748721|NCT00071110|E2|Reported Event|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
748722|NCT00071110|E1|Reported Event|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
748723|NCT00071032|B3|Baseline|Total|Total of all reporting groups
748724|NCT00071032|B2|Baseline|Restrictive Strategy|"Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.~Restrictive (Symptomatic) Transfusion Strategy: Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL."
748725|NCT00071032|B1|Baseline|Liberal (10 g/dL) Transfusion Strategy|"Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.~Liberal (10 g/dL) Transfusion Strategy: Maintains postoperative Hgb levels above 10 g/dL. This threshold strategy uses enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization."
748726|NCT00071032|P2|Participant Flow|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
748727|NCT00071032|P1|Participant Flow|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
748728|NCT00071032|O2|Outcome|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
748729|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
748730|NCT00071032|O2|Outcome|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
748731|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
748732|NCT00071032|E2|Reported Event|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
748733|NCT00071032|E1|Reported Event|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains post randomization Hgb levels >= 10 g/dL
748734|NCT00071006|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748735|NCT00071006|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748736|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748737|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748738|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748739|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748740|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748741|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748742|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748743|NCT00071006|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
748744|NCT00070941|B4|Baseline|Total|Total of all reporting groups
748745|NCT00070941|B3|Baseline|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
748746|NCT00070941|B2|Baseline|Escitalopram|oral Escitalopram 10mg or 20m
748747|NCT00070941|B1|Baseline|SAM-e|oral SAM-e, 1200mg or 2400 mg
748754|NCT00070941|E3|Reported Event|Placebo|Group C/Twenty patients receiving oral placebo Escitalopram an
748755|NCT00070941|E2|Reported Event|Oral Escitalopram|Group B/Forty patients receiving oral Escitalopram 10mg or 20m
748756|NCT00070941|E1|Reported Event|SAM-e|Group A/Forty patients receiving oral SAM-e, 1200mg or 2400 mg
748757|NCT00071058|B1|Baseline|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
748758|NCT00071058|P1|Participant Flow|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
748759|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
748760|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
748761|NCT00071058|E1|Reported Event|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
748762|NCT00003907|B3|Baseline|Total|Total of all reporting groups
748763|NCT00003907|B2|Baseline|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748764|NCT00003907|B1|Baseline|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748765|NCT00003907|P2|Participant Flow|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748766|NCT00003907|P1|Participant Flow|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748767|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748768|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748769|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748770|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748771|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748772|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748773|NCT00003907|E2|Reported Event|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748774|NCT00003907|E1|Reported Event|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
748775|NCT00070564|B7|Baseline|Total|Total of all reporting groups
748849|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
748850|NCT00070499|O3|Outcome|Dasatinib|
748851|NCT00070499|O2|Outcome|High Dose Imatinib|
748852|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
748776|NCT00070564|B6|Baseline|ARM VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
748777|NCT00070564|B5|Baseline|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
748778|NCT00070564|B4|Baseline|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748779|NCT00070564|B3|Baseline|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748780|NCT00070564|B2|Baseline|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748781|NCT00070564|B1|Baseline|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748782|NCT00070564|P6|Participant Flow|Arm VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
748783|NCT00070564|P5|Participant Flow|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
748784|NCT00070564|P4|Participant Flow|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748785|NCT00070564|P3|Participant Flow|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748786|NCT00070564|P2|Participant Flow|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748787|NCT00070564|P1|Participant Flow|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748788|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748789|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748790|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748853|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
748854|NCT00070499|O3|Outcome|Dasatinib|
748855|NCT00070499|O2|Outcome|High Dose Imatinib|
748856|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
748978|NCT00069823|E1|Reported Event|Placebo|40 mg of placebo twice daily
748791|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748792|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748793|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748794|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748795|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748796|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748797|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748798|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748799|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748800|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748801|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748802|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748803|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748804|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748805|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748806|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748857|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
748858|NCT00070499|O3|Outcome|Dasatinib|
748859|NCT00070499|O2|Outcome|High Dose Imatinib|
748807|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748808|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748809|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748810|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748811|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748812|NCT00070564|O6|Outcome|ARM VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
748813|NCT00070564|O5|Outcome|ARM V|"Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
748814|NCT00070564|O4|Outcome|ARM IV|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
748815|NCT00070564|O3|Outcome|ARM III|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
748816|NCT00070564|O2|Outcome|ARM II|(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
748817|NCT00070564|O1|Outcome|ARM I|(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
748818|NCT00070564|O6|Outcome|Arm VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
748819|NCT00070564|O5|Outcome|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
748820|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748821|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748822|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748860|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
748861|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Standard dose imatinib B
748862|NCT00070499|O3|Outcome|Dasatinib|Dasatinib
748863|NCT00070499|O2|Outcome|High Dose Imatinib|High dose imatinib
748823|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748824|NCT00070564|O6|Outcome|Arm VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
748825|NCT00070564|O5|Outcome|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
748826|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748827|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748828|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748829|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
748830|NCT00070564|E6|Reported Event|ARM VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
748831|NCT00070564|E5|Reported Event|ARM V|"Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
748832|NCT00070564|E4|Reported Event|ARM IV|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
748833|NCT00070564|E3|Reported Event|ARM III|(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
748834|NCT00070564|E2|Reported Event|ARM II|(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
748835|NCT00070564|E1|Reported Event|ARM I|(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
748836|NCT00070499|B5|Baseline|Total|Total of all reporting groups
748837|NCT00070499|B4|Baseline|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
748838|NCT00070499|B3|Baseline|Dasatinib|
748839|NCT00070499|B2|Baseline|High Dose Imatinib|
748840|NCT00070499|B1|Baseline|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
748841|NCT00070499|P4|Participant Flow|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
748842|NCT00070499|P3|Participant Flow|Dasatinib|Dasatinib dose was 100 mg daily
748843|NCT00070499|P2|Participant Flow|High Dose Imatinib|High dose imatinib was 800 mg daily.
748844|NCT00070499|P1|Participant Flow|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily.
748845|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib. patients received 400 mg imatinib daily
748846|NCT00070499|O3|Outcome|Dasatinib|Patients received 100 mg dasatinib daily
748847|NCT00070499|O2|Outcome|High Dose Imatinib|Patients received 800 mg imatinib daily
748848|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib. patients received 400 mg imatinib daily
748865|NCT00070499|E4|Reported Event|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
748866|NCT00070499|E3|Reported Event|Dasatinib|Patients received 100 mg dasatinib daily
748867|NCT00070499|E2|Reported Event|High Dose Imatinib|Patients received 800 mg imatinib daily
748868|NCT00070499|E1|Reported Event|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily
748869|NCT00070317|B1|Baseline|Diagnostic|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
748870|NCT00070317|P1|Participant Flow|Radionuclide and Isosulfan Blue Injection|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
748871|NCT00070317|O1|Outcome|Diagnostic|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
748872|NCT00070317|O1|Outcome|Diagnostic|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
748873|NCT00070317|E1|Reported Event|Diagnostic|"Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.~Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid"
748874|NCT00070291|B1|Baseline|Cyclosporine|
748875|NCT00070291|P1|Participant Flow|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
748876|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
748891|NCT00070109|P5|Participant Flow|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748979|NCT00069641|B4|Baseline|Total|Total of all reporting groups
748877|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
748878|NCT00070291|E1|Reported Event|Cyclosporine|High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
748879|NCT00070135|B1|Baseline|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
748880|NCT00070135|P1|Participant Flow|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
748881|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
748882|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
748883|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
748884|NCT00070135|E1|Reported Event|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover"
748885|NCT00070109|B6|Baseline|Total|Total of all reporting groups
748886|NCT00070109|B5|Baseline|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748887|NCT00070109|B4|Baseline|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748888|NCT00070109|B3|Baseline|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748889|NCT00070109|B2|Baseline|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748890|NCT00070109|B1|Baseline|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
748973|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748974|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748892|NCT00070109|P4|Participant Flow|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748893|NCT00070109|P3|Participant Flow|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748894|NCT00070109|P2|Participant Flow|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
748895|NCT00070109|P1|Participant Flow|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.~trabectedin: Given IV~pharmacological study: Correlative studies"
748896|NCT00070109|O2|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
748897|NCT00070109|O1|Outcome|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
748898|NCT00070109|O4|Outcome|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748899|NCT00070109|O3|Outcome|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748900|NCT00070109|O2|Outcome|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748901|NCT00070109|O1|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748902|NCT00070109|E5|Reported Event|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748903|NCT00070109|E4|Reported Event|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748904|NCT00070109|E3|Reported Event|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748905|NCT00070109|E2|Reported Event|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
748906|NCT00070109|E1|Reported Event|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
748907|NCT00070018|B1|Baseline|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
748908|NCT00070018|P1|Participant Flow|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
748909|NCT00070018|O1|Outcome|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
748910|NCT00070018|E1|Reported Event|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
748975|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748976|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748911|NCT00069953|B1|Baseline|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
748912|NCT00069953|P1|Participant Flow|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
748913|NCT00069953|O1|Outcome|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
748914|NCT00069953|E1|Reported Event|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
748915|NCT00069784|B3|Baseline|Total|Total of all reporting groups
748916|NCT00069784|B2|Baseline|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748917|NCT00069784|B1|Baseline|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748918|NCT00069784|P2|Participant Flow|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748919|NCT00069784|P1|Participant Flow|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748920|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748921|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748922|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748923|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748924|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748925|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748926|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748927|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748928|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748929|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748930|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748931|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748932|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748933|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748934|NCT00069784|E2|Reported Event|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
748935|NCT00069784|E1|Reported Event|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
748936|NCT00069823|B3|Baseline|Total|Total of all reporting groups
748937|NCT00069823|B2|Baseline|Esomeprazole|40 mg of esomeprazole twice daily
748938|NCT00069823|B1|Baseline|Placebo|40 mg of placebo twice daily
748939|NCT00069823|P2|Participant Flow|Esomeprazole|40 mg of esomeprazole twice daily
748940|NCT00069823|P1|Participant Flow|Placebo|40 mg of placebo twice daily
748941|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748942|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748943|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748944|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748945|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748946|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748947|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748948|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748949|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748950|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748951|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748952|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748953|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748954|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748955|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748956|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748957|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748958|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748959|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748960|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748961|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748962|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748963|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748964|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748965|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748966|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748967|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748968|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748969|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748970|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748971|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
748972|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
748980|NCT00069641|B3|Baseline|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
748981|NCT00069641|B2|Baseline|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
748982|NCT00069641|B1|Baseline|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
748983|NCT00069641|P3|Participant Flow|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
748984|NCT00069641|P2|Participant Flow|Idursulfase Every Other Week (EOW) (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
748985|NCT00069641|P1|Participant Flow|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered once-weekly by intravenous infusion for one year (52 infusions).
748986|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
748987|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
748988|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
748989|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
748990|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
748991|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
748992|NCT00069641|O2|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
748993|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
748994|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
748995|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
748996|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
748997|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
748998|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
748999|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
749000|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
749001|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
749002|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
749003|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
749004|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
749005|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
749006|NCT00069641|E3|Reported Event|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
749007|NCT00069641|E2|Reported Event|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
749008|NCT00069641|E1|Reported Event|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
749009|NCT00069277|B1|Baseline|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
749010|NCT00069277|P1|Participant Flow|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
749011|NCT00069277|O1|Outcome|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
749012|NCT00069277|E1|Reported Event|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
749013|NCT00069264|B1|Baseline|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
749014|NCT00069264|P1|Participant Flow|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
749015|NCT00069264|O1|Outcome|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
749016|NCT00069264|E1|Reported Event|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
749017|NCT00069329|B1|Baseline|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749018|NCT00069329|P1|Participant Flow|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749019|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749020|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749021|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749022|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749023|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749024|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749025|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749026|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749027|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749028|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749029|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749030|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749031|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749032|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749033|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749034|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749035|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749036|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749037|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749038|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749039|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749040|NCT00069329|E1|Reported Event|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
749041|NCT00069238|B1|Baseline|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
749042|NCT00069238|P3|Participant Flow|Alemtuzumab 90 mg|Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
749043|NCT00069238|P2|Participant Flow|Alemtuzumab 60 mg|Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
749044|NCT00069238|P1|Participant Flow|Alemtuzumab 30 mg|Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
749363|NCT00067990|P2|Participant Flow|Placebo|starting within 3 months of transplantation
749045|NCT00069238|O1|Outcome|All Participants|"All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.~The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level."
749046|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
749047|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
749048|NCT00069238|E1|Reported Event|All Participants|"All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.~The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level."
749049|NCT00069121|B3|Baseline|Total|Total of all reporting groups
749050|NCT00069121|B2|Baseline|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749051|NCT00069121|B1|Baseline|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749052|NCT00069121|P2|Participant Flow|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749053|NCT00069121|P1|Participant Flow|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749054|NCT00069121|O3|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749055|NCT00069121|O2|Outcome|5-FU/LV ROSWELL PARK|Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
749056|NCT00069121|O1|Outcome|5-FU/LV MAYO CLINIC|Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)
749057|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749058|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749059|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749060|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749364|NCT00067990|P1|Participant Flow|Losartan|100 mg/day starting within three months of transplantation
749061|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749062|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749063|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749064|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749065|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749066|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749067|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
749068|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
749069|NCT00069121|E3|Reported Event|XELOX|Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
749070|NCT00069121|E2|Reported Event|5-FU/LV ROSWELL PARK|5-fluorouracil/leucovorin
749071|NCT00069121|E1|Reported Event|5-FU/LV MAYO CLINIC|5-fluorouracil/leucovorin
749072|NCT00069108|B3|Baseline|Total|Total of all reporting groups
749073|NCT00069108|B2|Baseline|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749074|NCT00069108|B1|Baseline|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 IV infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749075|NCT00069108|P2|Participant Flow|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749179|NCT00069160|E1|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
749180|NCT00068822|B3|Baseline|Total|Total of all reporting groups
749181|NCT00068822|B2|Baseline|Control Group|Participants will receive partial vertebroplasty without PMMA
749076|NCT00069108|P1|Participant Flow|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749077|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749078|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749079|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749080|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749081|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749082|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749083|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749084|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749085|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749086|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749182|NCT00068822|B1|Baseline|Vertebroplasty|Participants will receive percutaneous vertebroplasty
749240|NCT00068588|E2|Reported Event|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749087|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749088|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749089|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749090|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749091|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749092|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749093|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749094|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749095|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749096|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749097|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749237|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749321|NCT00068341|O4|Outcome|Total|
749322|NCT00068341|O3|Outcome|HER2-|(Pre-Op TC)
749098|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749099|NCT00069108|E2|Reported Event|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
749100|NCT00069108|E1|Reported Event|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
749101|NCT00069095|B7|Baseline|Total|Total of all reporting groups
749102|NCT00069095|B6|Baseline|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749103|NCT00069095|B5|Baseline|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749104|NCT00069095|B4|Baseline|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749105|NCT00069095|B3|Baseline|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749106|NCT00069095|B2|Baseline|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749115|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749107|NCT00069095|B1|Baseline|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749108|NCT00069095|P6|Participant Flow|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749109|NCT00069095|P5|Participant Flow|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749110|NCT00069095|P4|Participant Flow|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749111|NCT00069095|P3|Participant Flow|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749112|NCT00069095|P2|Participant Flow|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749113|NCT00069095|P1|Participant Flow|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749114|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749323|NCT00068341|O2|Outcome|Arm II: HER2+|(Pre-Op TC, Post-Op Herceptin)
749116|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749117|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749118|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749119|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749120|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749121|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749122|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749123|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749172|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
749173|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
749174|NCT00069160|O2|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
749124|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749125|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749126|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749127|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749128|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749129|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749130|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749131|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749132|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749324|NCT00068341|O1|Outcome|Arm I: HER2+|(Pre-Op TCH)
749325|NCT00068341|E4|Reported Event|Total|
749133|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749134|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749135|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749136|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749137|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749138|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749139|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749140|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749141|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749175|NCT00069160|O1|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
749176|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
749142|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749143|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749144|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749145|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749146|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749147|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749148|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749149|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749150|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749177|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
749151|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749152|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749153|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
749154|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749155|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749156|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
749157|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
749158|NCT00069095|E6|Reported Event|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749178|NCT00069160|E2|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
749238|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749159|NCT00069095|E5|Reported Event|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749160|NCT00069095|E4|Reported Event|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749161|NCT00069095|E3|Reported Event|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749162|NCT00069095|E2|Reported Event|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749163|NCT00069095|E1|Reported Event|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
749164|NCT00069160|B3|Baseline|Total|Total of all reporting groups
749165|NCT00069160|B2|Baseline|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
749166|NCT00069160|B1|Baseline|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
749167|NCT00069160|P2|Participant Flow|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
749168|NCT00069160|P1|Participant Flow|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
749169|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
749170|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
749171|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
749183|NCT00068822|P2|Participant Flow|Control, Then Vertebroplasty|Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture).
749184|NCT00068822|P1|Participant Flow|Vertebroplasty, Then Control|Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.)
749185|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
749186|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
749187|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
749188|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
749189|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
749190|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
749191|NCT00068822|E2|Reported Event|Control Group|Participants will receive partial vertebroplasty without PMMA
749192|NCT00068822|E1|Reported Event|Vertebroplasty|Participants will receive percutaneous vertebroplasty
749193|NCT00068770|B3|Baseline|Total|Total of all reporting groups
749194|NCT00068770|B2|Baseline|nonp450 (-EIASD)|not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.
749195|NCT00068770|B1|Baseline|p450 ( +EIASD)|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
749196|NCT00068770|P2|Participant Flow|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
749197|NCT00068770|P1|Participant Flow|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
749198|NCT00068770|O2|Outcome|nonp450 (-EIASD)|"not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
749199|NCT00068770|O1|Outcome|p450 ( +EIASD)|"on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
749200|NCT00068770|O2|Outcome|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
749201|NCT00068770|O1|Outcome|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
749202|NCT00068770|E2|Reported Event|Non P450 ARM|NOT on p450 inhibitor *non P450 ARM (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate, Keppra.
749203|NCT00068770|E1|Reported Event|P450 ARM|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
749204|NCT00068718|B1|Baseline|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749205|NCT00068718|P1|Participant Flow|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749206|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749207|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749208|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749209|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749239|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749360|NCT00067990|B3|Baseline|Total|Total of all reporting groups
749210|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749211|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749212|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749213|NCT00068718|E1|Reported Event|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
749214|NCT00068601|B3|Baseline|Total|Total of all reporting groups
749215|NCT00068601|B2|Baseline|Arm 2|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
749216|NCT00068601|B1|Baseline|Arm 1|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
749217|NCT00068601|P2|Participant Flow|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
749218|NCT00068601|P1|Participant Flow|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
749219|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
749220|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
749221|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
749222|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
749223|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
749224|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
749225|NCT00068601|E2|Reported Event|Chemotherapy Plus Goserelin|Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen. goserelin acetate: Given subcutaneously
749226|NCT00068601|E1|Reported Event|Standard Chemotherapy|Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen
749227|NCT00068588|B4|Baseline|Total|Total of all reporting groups
749228|NCT00068588|B3|Baseline|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749229|NCT00068588|B2|Baseline|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749230|NCT00068588|B1|Baseline|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749231|NCT00068588|P3|Participant Flow|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749232|NCT00068588|P2|Participant Flow|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749233|NCT00068588|P1|Participant Flow|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749234|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749235|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749236|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749361|NCT00067990|B2|Baseline|Placebo|within 3 months of transplantation
749241|NCT00068588|E1|Reported Event|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
749242|NCT00068575|B1|Baseline|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
749243|NCT00068575|P1|Participant Flow|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
749244|NCT00068575|O1|Outcome|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
749245|NCT00068575|E1|Reported Event|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
749246|NCT00068445|B3|Baseline|Total|Total of all reporting groups
749247|NCT00068445|B2|Baseline|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749248|NCT00068445|B1|Baseline|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749249|NCT00068445|P2|Participant Flow|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749250|NCT00068445|P1|Participant Flow|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749251|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749252|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749253|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749254|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749255|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749256|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749257|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749258|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749259|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749260|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749261|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749262|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749263|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749264|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749265|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749266|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749267|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749268|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749269|NCT00068445|O2|Outcome|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749362|NCT00067990|B1|Baseline|Losartan|within 3 months of transplantation
749270|NCT00068445|O1|Outcome|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749271|NCT00068445|E2|Reported Event|Arm II - Placebo|Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749272|NCT00068445|E1|Reported Event|Arm I - Lamotrigine|Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
749273|NCT00068419|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
749274|NCT00068419|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
749275|NCT00068419|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
749276|NCT00068419|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
749277|NCT00068406|B1|Baseline|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
749278|NCT00068406|P1|Participant Flow|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
749279|NCT00068406|O1|Outcome|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
749280|NCT00068406|O1|Outcome|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
749281|NCT00068406|E1|Reported Event|Cisplatin + Radiation, Then Surgery|Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
749282|NCT00068393|B1|Baseline|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
749283|NCT00068393|P1|Participant Flow|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
749284|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
749285|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
749286|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
749287|NCT00068393|E1|Reported Event|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
749288|NCT00068380|B1|Baseline|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749289|NCT00068380|P1|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749290|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749291|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749292|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749293|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749294|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749295|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749296|NCT00068380|E1|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
749297|NCT00068367|B1|Baseline|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
749298|NCT00068367|P1|Participant Flow|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
749299|NCT00068367|O1|Outcome|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
749300|NCT00068367|O1|Outcome|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
749301|NCT00068367|O1|Outcome|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
749302|NCT00068367|E1|Reported Event|Arm I (OSI-774)|OSI-774 150 mg daily for 25 weeks
749303|NCT00068341|B4|Baseline|Total|Total of all reporting groups
749304|NCT00068341|B3|Baseline|HER2/Neu Negative Patients|"please see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
749305|NCT00068341|B2|Baseline|Arm II (Neoadjuvant Therapy)|"please see intervention description~trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
749306|NCT00068341|B1|Baseline|Arm I (Neoadjuvant Therapy)|"see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV~trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
749307|NCT00068341|P3|Participant Flow|HER2/Neu Negative Patients|"please see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
749308|NCT00068341|P2|Participant Flow|Arm II (Neoadjuvant Therapy)|"please see intervention description~trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
749309|NCT00068341|P1|Participant Flow|Arm I (Neoadjuvant Therapy)|"see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV (AUC = area under the curve, total drug exposure over time)~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV~trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
749310|NCT00068341|O3|Outcome|Her2- (Pre-op TC)|enrolled subjects
749311|NCT00068341|O2|Outcome|Her2+ (Pre-op TC, Post-op Herceptin)|enrolled subjects
749312|NCT00068341|O1|Outcome|Arm I (Pre-op TCH)|enrolled subjects
749313|NCT00068341|O2|Outcome|Pathologic CR - No|All enrolled subjects
749314|NCT00068341|O1|Outcome|Pathologic CR - Yes|All enrolled subjects
749315|NCT00068341|O3|Outcome|Arm III: Her -|all enrolled subjects
749316|NCT00068341|O2|Outcome|Arm II: Her2 +|all enrolled subjects
749317|NCT00068341|O1|Outcome|Arm I: Her2 +|all enrolled subjects
749318|NCT00068341|O3|Outcome|Arm III: Her2-|all evaluated subjects.
749319|NCT00068341|O2|Outcome|Arm II:Her2+|all evaluated subjects.
749320|NCT00068341|O1|Outcome|Arm I: Her2+|all evaluated subjects.
749326|NCT00068341|E3|Reported Event|Arm III: HER2- (Pre-Op TC)|HER2/neu negative patients carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
749327|NCT00068341|E2|Reported Event|Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin)|Arm II trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
749328|NCT00068341|E1|Reported Event|Arm I: HER+ (Pre-Op TCH)|Arm I carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
749329|NCT00068250|B4|Baseline|Total|Total of all reporting groups
749330|NCT00068250|B3|Baseline|Phase II: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749331|NCT00068250|B2|Baseline|Phase I: Temozolomide 150 mg|Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749332|NCT00068250|B1|Baseline|Phase I: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749333|NCT00068250|P4|Participant Flow|Phase II: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749334|NCT00068250|P3|Participant Flow|Phase I: Temozolomide 200 mg|Rituximab, methotrexate, temozolomide 200 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749335|NCT00068250|P2|Participant Flow|Phase I: Temozolomide 150 mg|Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749336|NCT00068250|P1|Participant Flow|Phase I: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749337|NCT00068250|O1|Outcome|Combined Temozolomide 100mg Arms|Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
749338|NCT00068250|O1|Outcome|Combined Temozolomide 100mg Arms|Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
749339|NCT00068250|O1|Outcome|Combined Temozolomide 100mg Arms|Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
749340|NCT00068250|O2|Outcome|Phase I: Temozolomide150 mg|Phase I: Temozolomide 150 mg
749341|NCT00068250|O1|Outcome|Phase I: Temozolomide 100mg|Phase I: Temozolomide 100mg
749342|NCT00068250|E3|Reported Event|Phase II: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749343|NCT00068250|E2|Reported Event|Phase I: Temozolomide 150 mg|Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749344|NCT00068250|E1|Reported Event|Phase I: Temozolomide 100 mg|Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
749345|NCT00068237|B1|Baseline|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
749346|NCT00068237|P1|Participant Flow|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
749347|NCT00068237|O1|Outcome|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
749348|NCT00068237|E1|Reported Event|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
749349|NCT00068107|B1|Baseline|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
749350|NCT00068107|P1|Participant Flow|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
749351|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
749352|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
749353|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
749354|NCT00068107|O2|Outcome|All Participants at Last Observation|
749355|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
749356|NCT00068107|O2|Outcome|All Participants at Last Observation|
749357|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
749358|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
749359|NCT00068107|E1|Reported Event|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
749369|NCT00067990|E2|Reported Event|Placebo|within 3 months of transplantation
749370|NCT00067990|E1|Reported Event|Losartan|within 3 months of transplantation
749371|NCT00067808|B4|Baseline|Total|Total of all reporting groups
749372|NCT00067808|B3|Baseline|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
749373|NCT00067808|B2|Baseline|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
749374|NCT00067808|B1|Baseline|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
749375|NCT00067808|P3|Participant Flow|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
749376|NCT00067808|P2|Participant Flow|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
749377|NCT00067808|P1|Participant Flow|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
749378|NCT00067808|O3|Outcome|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
749379|NCT00067808|O2|Outcome|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
749380|NCT00067808|O1|Outcome|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
749381|NCT00067808|E3|Reported Event|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
749382|NCT00067808|E2|Reported Event|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
749383|NCT00067808|E1|Reported Event|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
749384|NCT00067470|B3|Baseline|Total|Total of all reporting groups
749385|NCT00067470|B2|Baseline|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
749386|NCT00067470|B1|Baseline|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
749387|NCT00067470|P2|Participant Flow|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
749388|NCT00067470|P1|Participant Flow|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
749389|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
749390|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
749391|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
749392|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
749393|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
749394|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
749395|NCT00067470|E2|Reported Event|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
749396|NCT00067470|E1|Reported Event|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
749397|NCT00067236|B3|Baseline|Total|Total of all reporting groups
749398|NCT00067236|B2|Baseline|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
749399|NCT00067236|B1|Baseline|Placebo|Placebo tablet twice daily for 90 days
749400|NCT00067236|P2|Participant Flow|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
749401|NCT00067236|P1|Participant Flow|Placebo|Placebo tablet twice daily for 90 days
749402|NCT00067236|O2|Outcome|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
749403|NCT00067236|O1|Outcome|Placebo|Placebo tablet twice daily for 90 days
749404|NCT00067236|E2|Reported Event|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
749405|NCT00067236|E1|Reported Event|Placebo|Placebo tablet twice daily for 90 days
749406|NCT00066963|B4|Baseline|Total|Total of all reporting groups
749407|NCT00066963|B3|Baseline|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
749408|NCT00066963|B2|Baseline|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
749409|NCT00066963|B1|Baseline|No Intervention: Counseling Only|Counseling Only (0FV)
749410|NCT00066963|P3|Participant Flow|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
749411|NCT00066963|P2|Participant Flow|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
749412|NCT00066963|P1|Participant Flow|No Intervention: Counseling Only|Counseling Only (0FV)
749413|NCT00066963|O3|Outcome|FV 2x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months)
749414|NCT00066963|O2|Outcome|FV 1x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) once per year for 2 years (every 12 months) plus caregiver counseling
749415|NCT00066963|O1|Outcome|Counseling Only|caregiver counseling only (zero fluoride varnish)
749416|NCT00066963|E3|Reported Event|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
749417|NCT00066963|E2|Reported Event|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
749418|NCT00066963|E1|Reported Event|No Intervention: Counseling Only|Counseling Only (0FV)
749419|NCT00066937|B5|Baseline|Total|Total of all reporting groups
749420|NCT00066937|B4|Baseline|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
749421|NCT00066937|B3|Baseline|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
749422|NCT00066937|B2|Baseline|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
749423|NCT00066937|B1|Baseline|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
749679|NCT00065507|P1|Participant Flow|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749424|NCT00066937|P4|Participant Flow|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
749425|NCT00066937|P3|Participant Flow|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
749426|NCT00066937|P2|Participant Flow|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
749427|NCT00066937|P1|Participant Flow|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
749428|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
749429|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
749430|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
749431|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
749432|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
749433|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
749434|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
749435|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
749436|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
749437|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
749438|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
749439|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
749440|NCT00066937|O4|Outcome|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
749441|NCT00066937|O3|Outcome|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
749442|NCT00066937|O2|Outcome|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
749443|NCT00066937|O1|Outcome|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
749444|NCT00066937|E4|Reported Event|Benztropine Oral Product/Disease MGT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
749445|NCT00066937|E3|Reported Event|Nortriptyline Oral Capsule/Disease MGT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.
749446|NCT00066937|E2|Reported Event|Benztropine Oral Product/CBT|Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.
749447|NCT00066937|E1|Reported Event|Nortriptyline Oral Capsule/CBT|Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.
749448|NCT00066807|B3|Baseline|Total|Total of all reporting groups
749449|NCT00066807|B2|Baseline|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749450|NCT00066807|B1|Baseline|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749451|NCT00066807|P2|Participant Flow|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749452|NCT00066807|P1|Participant Flow|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749453|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749454|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749673|NCT00065611|E2|Reported Event|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
749455|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749456|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749457|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749458|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749459|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749460|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749461|NCT00066807|E2|Reported Event|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749462|NCT00066807|E1|Reported Event|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
749463|NCT00066781|B3|Baseline|Total|Total of all reporting groups
749464|NCT00066781|B2|Baseline|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
749465|NCT00066781|B1|Baseline|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
749466|NCT00066781|P2|Participant Flow|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
749467|NCT00066781|P1|Participant Flow|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
749468|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
749469|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
749470|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
749471|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
749472|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
749473|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
749474|NCT00066781|E2|Reported Event|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
749475|NCT00066781|E1|Reported Event|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
749476|NCT00066742|B1|Baseline|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
749477|NCT00066742|P1|Participant Flow|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
749478|NCT00066742|O1|Outcome|Evaluable Patients|
749479|NCT00066742|O1|Outcome|Evaluable Patients With Measurable Disease|Only eligible patients who received protocol treatment and who had measurable lesions (per RECIST) at baseline were included in this analysis.
749480|NCT00066742|O1|Outcome|Evaluable Patients|
749481|NCT00066742|E2|Reported Event|Consolidation Cisplatin + Etoposide|
749482|NCT00066742|E1|Reported Event|Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy|
749483|NCT00066703|B3|Baseline|Total|Total of all reporting groups
749484|NCT00066703|B2|Baseline|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749485|NCT00066703|B1|Baseline|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749486|NCT00066703|P2|Participant Flow|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749487|NCT00066703|P1|Participant Flow|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749488|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749489|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749490|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749491|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749492|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749493|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749494|NCT00066703|E2|Reported Event|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749495|NCT00066703|E1|Reported Event|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
749496|NCT00066690|B4|Baseline|Total|Total of all reporting groups
749497|NCT00066690|B3|Baseline|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749498|NCT00066690|B2|Baseline|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749499|NCT00066690|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
749500|NCT00066690|P3|Participant Flow|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749501|NCT00066690|P2|Participant Flow|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749502|NCT00066690|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
749503|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749504|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749505|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
749506|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749507|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749508|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
749509|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749510|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749511|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
749512|NCT00066690|E3|Reported Event|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749513|NCT00066690|E2|Reported Event|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
749514|NCT00066690|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
749515|NCT00066573|B3|Baseline|Total|Total of all reporting groups
749516|NCT00066573|B2|Baseline|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
749517|NCT00066573|B1|Baseline|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
749518|NCT00066573|P2|Participant Flow|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
749519|NCT00066573|P1|Participant Flow|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
749520|NCT00066573|O2|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
749521|NCT00066573|O1|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
749522|NCT00066573|O2|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
749523|NCT00066573|O1|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
749524|NCT00066573|O2|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
749525|NCT00066573|O1|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
749526|NCT00066573|O2|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
749527|NCT00066573|O1|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
749528|NCT00066573|E2|Reported Event|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
749529|NCT00066573|E1|Reported Event|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
749530|NCT00066469|B1|Baseline|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
749531|NCT00066469|P1|Participant Flow|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
749532|NCT00066469|O1|Outcome|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
749533|NCT00066469|E1|Reported Event|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
749534|NCT00066365|B3|Baseline|Total|Total of all reporting groups
749535|NCT00066365|B2|Baseline|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749536|NCT00066365|B1|Baseline|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749588|NCT00066170|E3|Reported Event|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749589|NCT00066170|E2|Reported Event|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749590|NCT00066170|E1|Reported Event|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749591|NCT00066066|B4|Baseline|Total|Total of all reporting groups
749674|NCT00065611|E1|Reported Event|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
749537|NCT00066365|P2|Participant Flow|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749538|NCT00066365|P1|Participant Flow|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749539|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749540|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749541|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749542|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749543|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749544|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749675|NCT00065507|B3|Baseline|Total|Total of all reporting groups
749545|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749546|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749547|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749548|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749549|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749550|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749551|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749552|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749676|NCT00065507|B2|Baseline|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749553|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749554|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749555|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749556|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749557|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms~conventional surgery: thoracotomy"
749558|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749559|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749560|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749677|NCT00065507|B1|Baseline|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749561|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749562|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
749563|NCT00066365|E2|Reported Event|Group 2 (Bilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
749564|NCT00066365|E1|Reported Event|Group 1 (Unilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
749565|NCT00066222|B1|Baseline|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749566|NCT00066222|P1|Participant Flow|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749567|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749568|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749569|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749570|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749571|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749572|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749573|NCT00066222|E1|Reported Event|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
749574|NCT00066170|B5|Baseline|Total|Total of all reporting groups
749575|NCT00066170|B4|Baseline|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749576|NCT00066170|B3|Baseline|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749577|NCT00066170|B2|Baseline|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749578|NCT00066170|B1|Baseline|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749579|NCT00066170|P4|Participant Flow|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749580|NCT00066170|P3|Participant Flow|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749581|NCT00066170|P2|Participant Flow|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749582|NCT00066170|P1|Participant Flow|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749583|NCT00066170|O4|Outcome|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749584|NCT00066170|O3|Outcome|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749585|NCT00066170|O2|Outcome|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749586|NCT00066170|O1|Outcome|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
749587|NCT00066170|E4|Reported Event|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
749592|NCT00066066|B3|Baseline|SRP and Amoxicillin, MET and Locally Delivered Tetracycline|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
749593|NCT00066066|B2|Baseline|SRP and Metronidazole (MET)|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
749594|NCT00066066|B1|Baseline|Scaling and Root Planing (SRP) Only|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
749595|NCT00066066|P6|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
749596|NCT00066066|P5|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
749597|NCT00066066|P4|Participant Flow|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
749598|NCT00066066|P3|Participant Flow|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
749599|NCT00066066|P2|Participant Flow|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
749600|NCT00066066|P1|Participant Flow|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
749601|NCT00066066|O6|Outcome|SRP + MET + Amoxicillin + Doxycycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
749602|NCT00066066|O5|Outcome|SRP + MET + Amoxicillin + Doxycycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
749603|NCT00066066|O4|Outcome|SRP + Metronidazole Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
749604|NCT00066066|O3|Outcome|SRP + Metronidazole NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
749605|NCT00066066|O2|Outcome|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
749606|NCT00066066|O1|Outcome|Scaling and Root Planing Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
749607|NCT00066066|E6|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
749661|NCT00014560|E1|Reported Event|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
749608|NCT00066066|E5|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
749609|NCT00066066|E4|Reported Event|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
749610|NCT00066066|E3|Reported Event|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
749611|NCT00066066|E2|Reported Event|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
749612|NCT00066066|E1|Reported Event|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
749613|NCT00065806|B3|Baseline|Total|Total of all reporting groups
749614|NCT00065806|B2|Baseline|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749615|NCT00065806|B1|Baseline|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749616|NCT00065806|P2|Participant Flow|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749617|NCT00065806|P1|Participant Flow|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749618|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749619|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749620|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749621|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749622|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749623|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749624|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749625|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749626|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749627|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749662|NCT00065611|B3|Baseline|Total|Total of all reporting groups
749663|NCT00065611|B2|Baseline|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
749628|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749629|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749630|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749631|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749632|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749633|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749634|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749635|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749664|NCT00065611|B1|Baseline|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
749665|NCT00065611|P2|Participant Flow|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
749636|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749637|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749638|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749639|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749640|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749641|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749642|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749643|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749666|NCT00065611|P1|Participant Flow|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
749667|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
749644|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749645|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749646|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749647|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749648|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749649|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749650|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749651|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749668|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
749669|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
749652|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749653|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749654|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749655|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749656|NCT00065806|E2|Reported Event|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749657|NCT00065806|E1|Reported Event|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
749658|NCT00014560|B1|Baseline|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
749659|NCT00014560|P1|Participant Flow|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
749660|NCT00014560|O1|Outcome|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
749670|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
749671|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
749672|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
749678|NCT00065507|P2|Participant Flow|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749680|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749681|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749682|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749683|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749684|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749685|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749686|NCT00065507|O4|Outcome|Cumulative - Adefovir (ADV) 10 mg|
749687|NCT00065507|O3|Outcome|Cumulative - Entecavir (ETV) 1.0 mg|
749688|NCT00065507|O2|Outcome|Week 48 - Adefovir (ADV) 10 mg|
749689|NCT00065507|O1|Outcome|Week 48 - Entecavir (ETV) 1.0 mg|
749690|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749691|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749692|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749693|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749694|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749695|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749696|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749697|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749698|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749699|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749700|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749701|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749702|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749703|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749704|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749705|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749706|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749707|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749708|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749709|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749710|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749711|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749712|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749713|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749714|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749715|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749716|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749717|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749718|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749719|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749720|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749721|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749722|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749723|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749724|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749725|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749726|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749727|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749728|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749729|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749730|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749731|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749732|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749733|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749734|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749735|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749736|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
749737|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
749738|NCT00065507|E2|Reported Event|ENTECAVIR|
749739|NCT00065507|E1|Reported Event|ADEFOVIR|
749740|NCT00065468|B4|Baseline|Total|Total of all reporting groups
749741|NCT00065468|B3|Baseline|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749742|NCT00065468|B2|Baseline|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749743|NCT00065468|B1|Baseline|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749744|NCT00065468|P3|Participant Flow|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749745|NCT00065468|P2|Participant Flow|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749994|NCT00064662|E2|Reported Event|Sling|Pubovaginal sling, using autologous rectus fascia
749995|NCT00064662|E1|Reported Event|Burch|The Burch colposuspension
749746|NCT00065468|P1|Participant Flow|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749747|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749748|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749749|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749750|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749751|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749752|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749753|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749754|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749755|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749756|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749757|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749758|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749759|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749760|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749761|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749762|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749763|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749764|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749765|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749766|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749767|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749768|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749769|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749770|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749771|NCT00065468|E3|Reported Event|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
749772|NCT00065468|E2|Reported Event|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
749773|NCT00065468|E1|Reported Event|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
749774|NCT00065442|B3|Baseline|Total|Total of all reporting groups
749775|NCT00065442|B2|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
749776|NCT00065442|B1|Baseline|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
749996|NCT00064350|B4|Baseline|Total|Total of all reporting groups
749777|NCT00065442|P2|Participant Flow|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
749778|NCT00065442|P1|Participant Flow|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
749779|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
749780|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
749781|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
749782|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
749783|NCT00065442|E2|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
749784|NCT00065442|E1|Reported Event|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
749785|NCT00065429|B8|Baseline|Total|Total of all reporting groups
749786|NCT00065429|B7|Baseline|IMGN 75 mg/m2|Arm 7, Phase 1
749787|NCT00065429|B6|Baseline|IMGN 67.5 mg/m2|Arm 6, Phase 1
749788|NCT00065429|B5|Baseline|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
749789|NCT00065429|B4|Baseline|IMGN 40 mg/m2|Arm 4, Phase 1
749790|NCT00065429|B3|Baseline|IMGN 20 mg/m2|Arm 3, Phase 1
749791|NCT00065429|B2|Baseline|IMGN 10 mg/m2|Arm 2, Phase 1
749792|NCT00065429|B1|Baseline|IMGN 5 mg/m2|Arm 1, Phase 1
749793|NCT00065429|P7|Participant Flow|IMGN 75 mg/m2|Arm 7, Phase 1
749794|NCT00065429|P6|Participant Flow|IMGN 67.5 mg/m2|Arm 6, Phase 1
749795|NCT00065429|P5|Participant Flow|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
749796|NCT00065429|P4|Participant Flow|IMGN 40 mg/m2|Arm 4, Phase 1
749797|NCT00065429|P3|Participant Flow|IMGN 20 mg/m2|Arm 3, Phase 1
749798|NCT00065429|P2|Participant Flow|IMGN 10 mg/m2|Arm 2, Phase 1
749799|NCT00065429|P1|Participant Flow|IMGN 5 mg/m2|Arm 1, Phase 1
749800|NCT00065429|O2|Outcome|Phase II|For Phase II, the planned design was to use a Gehan's two-stage design [4], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.
749801|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
749802|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
749803|NCT00065429|E7|Reported Event|IMGN 75 mg/m2|Arm 7, Phase 1
749804|NCT00065429|E6|Reported Event|IMGN 67.5 mg/m2|Arm 6, Phase 1
749805|NCT00065429|E5|Reported Event|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
749806|NCT00065429|E4|Reported Event|IMGN 40 mg/m2|Arm 4, Phase 1
749807|NCT00065429|E3|Reported Event|IMGN 20 mg/m2|Arm 3, Phase 1
749808|NCT00065429|E2|Reported Event|IMGN 10 mg/m2|Arm 2, Phase 1
749809|NCT00065429|E1|Reported Event|IMGN 5 mg/m2|Arm 1, Phase 1
749810|NCT00065260|B3|Baseline|Total|Total of all reporting groups
749811|NCT00065260|B2|Baseline|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
750057|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
749812|NCT00065260|B1|Baseline|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
749813|NCT00065260|P2|Participant Flow|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
749814|NCT00065260|P1|Participant Flow|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
749815|NCT00065260|O2|Outcome|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
749816|NCT00065260|O1|Outcome|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
749817|NCT00065260|E2|Reported Event|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
749818|NCT00065260|E1|Reported Event|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
749819|NCT00065156|B1|Baseline|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749820|NCT00065156|P1|Participant Flow|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749821|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749822|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749823|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
750143|NCT00063622|B3|Baseline|Placebo|Placebo Pioglitazone and Placebo Vitamin E
749824|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749825|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749826|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749827|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749828|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749829|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749830|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749831|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749832|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749833|NCT00065156|E1|Reported Event|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
749834|NCT00065065|B3|Baseline|Total|Total of all reporting groups
749835|NCT00065065|B2|Baseline|Placebo|Identical in appearance to study drug taken twice a day
749836|NCT00065065|B1|Baseline|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
749837|NCT00065065|P2|Participant Flow|Placebo|Placebo identical to study drug twice daily for 12 weeks
749838|NCT00065065|P1|Participant Flow|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks
749839|NCT00065065|O2|Outcome|Placebo|"Identical in appearance to study drug taken twice daily for 12 weeks.~Placebo: pill that looks identical to rosiglitazone"
749840|NCT00065065|O1|Outcome|Rosiglitazone|"4 mg of rosiglitazone taken twice daily for 12 weeks.~Rosiglitazone: 4mg orally twice daily for 12 weeks"
749841|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
749842|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
749843|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
749844|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
749845|NCT00065065|E2|Reported Event|Placebo|Identical in appearance to study drug taken twice a day
749846|NCT00065065|E1|Reported Event|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
749847|NCT00003895|B3|Baseline|Total|Total of all reporting groups
749848|NCT00003895|B2|Baseline|Arm B (Every 3 Weeks)|
749849|NCT00003895|B1|Baseline|Arm A (Every 2 Weeks)|
749850|NCT00003895|P2|Participant Flow|gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
750144|NCT00063622|B2|Baseline|Vitamin E|Vitamin E at a dose of 800 IU daily
749851|NCT00003895|P1|Participant Flow|gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
749852|NCT00003895|O2|Outcome|Arm B (Every 3 Weeks, gp100:209-217(210M) + HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
749853|NCT00003895|O1|Outcome|Arm A (Every 2 Weeks, gp100:209-217(210M) and HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
749854|NCT00003895|E2|Reported Event|Arm B (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
749855|NCT00003895|E1|Reported Event|Arm A (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
749856|NCT00064987|B3|Baseline|Total|Total of all reporting groups
749857|NCT00064987|B2|Baseline|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749858|NCT00064987|B1|Baseline|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749859|NCT00064987|P2|Participant Flow|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749860|NCT00064987|P1|Participant Flow|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749861|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749862|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749863|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749864|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749865|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749866|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749867|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749868|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749869|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749870|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749871|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749872|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749873|NCT00064987|O2|Outcome|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749874|NCT00064987|O1|Outcome|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749875|NCT00064987|E2|Reported Event|Group 2 (GnRH)|Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
749876|NCT00064987|E1|Reported Event|Group 1 (FSH)|Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
749877|NCT00064844|B3|Baseline|Total|Total of all reporting groups
749878|NCT00064844|B2|Baseline|Nicotine Patch Plus Placebo Gum|
749879|NCT00064844|B1|Baseline|Nicotine Patch Plus Active Gum|
749880|NCT00064844|P2|Participant Flow|Nicotine Patch Plus Placebo Gum|
749881|NCT00064844|P1|Participant Flow|Nicotine Patch Plus Active Gum|
749882|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
749883|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
749884|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
749885|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
749886|NCT00064844|E2|Reported Event|Nicotine Patch Plus Placebo Gum|
749887|NCT00064844|E1|Reported Event|Nicotine Patch Plus Active Gum|
749888|NCT00064753|B3|Baseline|Total|Total of all reporting groups
749889|NCT00064753|B2|Baseline|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749890|NCT00064753|B1|Baseline|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749891|NCT00064753|P2|Participant Flow|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with estimated average requirement (EAR) amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749892|NCT00064753|P1|Participant Flow|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749893|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749894|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749895|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749896|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749897|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749898|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749899|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749900|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
750058|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
750059|NCT00064025|O2|Outcome|PR Positive (>0.2)|
749901|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749902|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749903|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749904|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749905|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749906|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749907|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749908|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749909|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749910|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749911|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749912|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749913|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749914|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749915|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749916|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749917|NCT00064753|E2|Reported Event|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749918|NCT00064753|E1|Reported Event|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
749919|NCT00064792|B3|Baseline|Total|Total of all reporting groups
749920|NCT00064792|B2|Baseline|Simvastatin Followed by Placebo|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
749921|NCT00064792|B1|Baseline|Placebo Followed by Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
749922|NCT00064792|P2|Participant Flow|Simvastatin Followed by Placebo|Subjects first received Simvastatin (1mg/kg/day after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol 150mg/kg/day for 12 months. After a 2 month wash out period, they then continued with cholesterol supplementation only.
749923|NCT00064792|P1|Participant Flow|Placebo Followed by Simvastatin|Subjects maintained cholesterol intake of 150mg/kg/day for 12 months. After a 2 month wash out period, they then received Simvastatin 1mg/kg/day (after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol.
749924|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
749925|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
749926|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
749927|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
749928|NCT00064792|E2|Reported Event|Simvastatin Susp|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
749929|NCT00064792|E1|Reported Event|OraPlus|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
749930|NCT00064701|B4|Baseline|Total|Total of all reporting groups
749931|NCT00064701|B3|Baseline|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749932|NCT00064701|B2|Baseline|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749933|NCT00064701|B1|Baseline|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749934|NCT00064701|P3|Participant Flow|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749935|NCT00064701|P2|Participant Flow|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749936|NCT00064701|P1|Participant Flow|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749937|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749938|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749939|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749940|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749941|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749942|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749943|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749944|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749945|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749946|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749947|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749948|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749949|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749950|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749951|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749952|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749953|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749954|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749955|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
750012|NCT00064350|E4|Reported Event|Randomization (Step 2): Mixed|"After induction treatment, patients with stable disease were randomized to receive either sorafenib or placebo. Due to drug dispensing error, 10 patients from the sorafenib arm and 2 patients from the placebo arm (12 pts in total) received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities."
749956|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749957|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749958|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749959|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749960|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749961|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749962|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749963|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749964|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749965|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749966|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749967|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749968|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749969|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749970|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
750013|NCT00064350|E3|Reported Event|Randomization (Step 2): Placebo|"After induction treatment, 46 patients were randomized to the placebo arm. Among these, 40 received treatment. However, due to drug dispensing error, 2 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 38 treated patients were included in the randomization (step 2): placebo group."
749971|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749972|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749973|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749974|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749975|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749976|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749977|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749978|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749979|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749980|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749981|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749982|NCT00064701|E3|Reported Event|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749983|NCT00064701|E2|Reported Event|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749984|NCT00064701|E1|Reported Event|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
749985|NCT00064662|B3|Baseline|Total|Total of all reporting groups
749986|NCT00064662|B2|Baseline|Sling|Pubovaginal sling, using autologous rectus fascia
749987|NCT00064662|B1|Baseline|Burch|The Burch colposuspension
749988|NCT00064662|P2|Participant Flow|Sling|Pubovaginal sling, using autologous rectus fascia
749989|NCT00064662|P1|Participant Flow|Burch|The Burch colposuspension
749990|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
749991|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
749992|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
749993|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
749997|NCT00064350|B3|Baseline|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm.~To show baseline characteristics for eligible and treated patients in both the randomization phase (the most important part of this study) and the induction phase, this group contains the following patients:~eligible and treated patients who were not randomized (n=194)~randomized patients who were not eligible or did not start treatment in the randomization phase (n=24)~There were 218 patients in this group so the total number of patients is 299 and the entire cohort represents all eligible and treated patients in the induction phase."
749998|NCT00064350|B2|Baseline|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
749999|NCT00064350|B1|Baseline|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
750000|NCT00064350|P3|Participant Flow|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients in this group did not enter Step 2 (randomization part) after the induction phase."
750001|NCT00064350|P2|Participant Flow|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
750002|NCT00064350|P1|Participant Flow|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
750003|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
750004|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
750005|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
750006|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
750007|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
750008|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
750009|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
750010|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
750011|NCT00064350|E5|Reported Event|Crossover: Sorafenib|Patients on the placebo arm who develop progressive disease may cross over to receive sorafenib, and 27 patients from the placebo arm received sorafenib in Step 3 (crossover). Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them. In total, 37 patients registered to step 3 (crossover). Of these, 35 patients received treatment and were included in the toxicity analysis for the crossover (step 3) part.
750037|NCT00064259|P2|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
750060|NCT00064025|O1|Outcome|PR Negative (<=0.2)|
750014|NCT00064350|E2|Reported Event|Randomization (Step 2): Sorafenib|"After induction treatment, 59 patients were randomized to the sorafenib arm. Among these, 55 received treatment. However, due to drug dispensing error, 10 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 45 treated patients were included in the randomization (step 2): sorafenib group."
750015|NCT00064350|E1|Reported Event|Induction: Sorafenib|All patients who received induction treatment (333 patients), regardless of eligibility status, were included in the toxicity analysis.
750016|NCT00064337|B1|Baseline|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.~filgrastim~cyclophosphamide~dexamethasone~melphalan~thalidomide~peripheral blood"
750017|NCT00064337|P1|Participant Flow|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.~filgrastim~cyclophosphamide~dexamethasone~melphalan~thalidomide~peripheral blood"
750018|NCT00064337|O1|Outcome|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection:~MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year."
750019|NCT00064337|O1|Outcome|Treatment|"MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.~Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.~Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).~Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.~Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.~filgrastim~cyclophosphamide~dexamethasone~melphalan~thalidomide~peripheral blood"
750020|NCT00064337|E3|Reported Event|Dex/Thal|Dex/Thal - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition
750021|NCT00064337|E2|Reported Event|Autologous Transplants|Autologous Transplants � All patients
750022|NCT00064337|E1|Reported Event|PBSCC or Induction/PBSCC|Induction/PBSCC – High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition; PBSCC - Light Chain Amyloidosis/Light Chain Disposition
750023|NCT00064298|B3|Baseline|Total|Total of all reporting groups
750024|NCT00064298|B2|Baseline|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
750025|NCT00064298|B1|Baseline|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
750026|NCT00064298|P2|Participant Flow|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
750027|NCT00064298|P1|Participant Flow|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
750028|NCT00064298|O2|Outcome|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
750029|NCT00064298|O1|Outcome|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
750030|NCT00064298|O2|Outcome|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
750031|NCT00064298|O1|Outcome|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
750032|NCT00064298|E2|Reported Event|Arm II - Control|"Patients receive oral placebo twice daily.~placebo: Given orally"
750033|NCT00064298|E1|Reported Event|Arm I - JuicePlus|"Patients receive oral fruit and vegetable extracts twice daily.~fruit and vegetable extracts: Given orally"
750034|NCT00064259|B1|Baseline|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
750035|NCT00064259|P4|Participant Flow|Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 7 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
750036|NCT00064259|P3|Participant Flow|Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 5 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
750141|NCT00063635|E1|Reported Event|Metformin|Metformin, 500 mg, twice daily
750038|NCT00064259|P1|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 1000 mg/m2/d on days 4 to 7 and cisplatin 100 mg/m2 on day 4.
750039|NCT00064259|O1|Outcome|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
750040|NCT00064259|E1|Reported Event|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
750041|NCT00064038|B3|Baseline|Total|Total of all reporting groups
750042|NCT00064038|B2|Baseline|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
750043|NCT00064038|B1|Baseline|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
750044|NCT00064038|P3|Participant Flow|Crossover to Lenalidomide+Dexamethasone|"Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity.~Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
750045|NCT00064038|P2|Participant Flow|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
750046|NCT00064038|P1|Participant Flow|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
750047|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
750048|NCT00064038|O1|Outcome|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
750049|NCT00064038|O3|Outcome|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
750050|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
750051|NCT00064038|O1|Outcome|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
750052|NCT00064038|E3|Reported Event|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
750053|NCT00064038|E2|Reported Event|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
750054|NCT00064038|E1|Reported Event|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
750055|NCT00064025|B1|Baseline|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
750056|NCT00064025|P1|Participant Flow|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
750061|NCT00064025|E1|Reported Event|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
750062|NCT00063999|B3|Baseline|Total|Total of all reporting groups
750063|NCT00063999|B2|Baseline|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750064|NCT00063999|B1|Baseline|Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)|Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750065|NCT00063999|P2|Participant Flow|Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750066|NCT00063999|P1|Participant Flow|Doxorubicin, Cisplatin, Paclitaxel|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750067|NCT00063999|O2|Outcome|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750068|NCT00063999|O1|Outcome|Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)|Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750069|NCT00063999|O4|Outcome|Progesterone Receptor Negative|Patients with progesterone receptor negative tumors
750070|NCT00063999|O3|Outcome|Progesterone Receptor Positive|Patients with progesterone receptor positive tumors
750071|NCT00063999|O2|Outcome|Estrogen Receptor Negative|Patients with estrogen receptor negative tumors
750072|NCT00063999|O1|Outcome|Estrogen Receptor Positive|Patients with estrogen receptor positive tumors
750073|NCT00063999|O2|Outcome|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750074|NCT00063999|O1|Outcome|Arm I (Doxorubicin, Cisplatin, Paclitaxel)|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750075|NCT00063999|O2|Outcome|Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750076|NCT00063999|O1|Outcome|Doxorubicin, Cisplatin, Paclitaxel|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750077|NCT00063999|O2|Outcome|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750078|NCT00063999|O1|Outcome|Arm I (Doxorubicin, Cisplatin, Paclitaxel)|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750079|NCT00063999|E2|Reported Event|Arm II (Paclitaxel, Carboplatin)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750080|NCT00063999|E1|Reported Event|Arm I (Doxorubicin, Cisplatin, Paclitaxel)|Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
750081|NCT00063986|B1|Baseline|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750082|NCT00063986|P1|Participant Flow|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750083|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750084|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750085|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750142|NCT00063622|B4|Baseline|Total|Total of all reporting groups
750086|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750087|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750088|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750089|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750090|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750091|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750092|NCT00063986|E1|Reported Event|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
750093|NCT00063934|B1|Baseline|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
750094|NCT00063934|P1|Participant Flow|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
750095|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
750096|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
750097|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
750098|NCT00063934|E1|Reported Event|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
750099|NCT00063635|B4|Baseline|Total|Total of all reporting groups
750100|NCT00063635|B3|Baseline|Placebo|Matching placebo
750101|NCT00063635|B2|Baseline|Vitamin E|Vitamin E, 400 IU, twice daily
750102|NCT00063635|B1|Baseline|Metformin|Metformin, 500 mg, twice daily
750103|NCT00063635|P3|Participant Flow|Placebo|Matching placebo
750104|NCT00063635|P2|Participant Flow|Vitamin E|Vitamin E, 400 IU, twice daily
750105|NCT00063635|P1|Participant Flow|Metformin|Metformin, 500 mg, twice daily
750106|NCT00063635|O3|Outcome|Placebo|Matching placebo
750107|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750108|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750109|NCT00063635|O3|Outcome|Placebo|Matching placebo
750110|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750111|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750112|NCT00063635|O3|Outcome|Placebo|Matching placebo
750113|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750114|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750115|NCT00063635|O3|Outcome|Placebo|Matching placebo
750116|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750117|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750118|NCT00063635|O3|Outcome|Placebo|Matching placebo
750119|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750120|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750121|NCT00063635|O3|Outcome|Placebo|Matching placebo
750122|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750123|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750124|NCT00063635|O3|Outcome|Placebo|Matching placebo
750125|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750126|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750127|NCT00063635|O3|Outcome|Placebo|Matching placebo
750128|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750129|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750130|NCT00063635|O3|Outcome|Placebo|Matching placebo
750131|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750132|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750133|NCT00063635|O3|Outcome|Placebo|Matching placebo
750134|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750135|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750136|NCT00063635|O3|Outcome|Placebo|Matching placebo
750137|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
750138|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
750139|NCT00063635|E3|Reported Event|Placebo|Matching placebo
750140|NCT00063635|E2|Reported Event|Vitamin E|Vitamin E, 400 IU, twice daily
750145|NCT00063622|B1|Baseline|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750146|NCT00063622|P3|Participant Flow|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750147|NCT00063622|P2|Participant Flow|Vitamin E|Vitamin E at a dose of 800 IU daily
750148|NCT00063622|P1|Participant Flow|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750149|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750150|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
750151|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750152|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750153|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
750154|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750155|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750156|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
750157|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750158|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750159|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
750160|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750161|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750162|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
750163|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750164|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750165|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
750166|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750167|NCT00063622|E3|Reported Event|Placebo|Placebo Pioglitazone and Placebo Vitamin E
750168|NCT00063622|E2|Reported Event|Vitamin E|Vitamin E at a dose of 800 IU daily
750169|NCT00063622|E1|Reported Event|Pioglitazone|Pioglitazone at a dose of 30 mg daily
750170|NCT00063570|B3|Baseline|Total|Total of all reporting groups
750171|NCT00063570|B2|Baseline|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750172|NCT00063570|B1|Baseline|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750173|NCT00063570|P2|Participant Flow|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750174|NCT00063570|P1|Participant Flow|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750175|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750176|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750177|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750178|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750179|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750180|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750181|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750182|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750183|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750184|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750185|NCT00063570|E2|Reported Event|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
750186|NCT00063570|E1|Reported Event|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
750187|NCT00063362|B3|Baseline|Total|Total of all reporting groups
750188|NCT00063362|B2|Baseline|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
750211|NCT00063154|E1|Reported Event|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
750235|NCT00062751|P2|Participant Flow|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750189|NCT00063362|B1|Baseline|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
750190|NCT00063362|P2|Participant Flow|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
750191|NCT00063362|P1|Participant Flow|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent/L (mEq/L)."
750192|NCT00063362|O2|Outcome|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
750193|NCT00063362|O1|Outcome|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
750194|NCT00063362|E2|Reported Event|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
750195|NCT00063362|E1|Reported Event|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
750196|NCT00063258|B3|Baseline|Total|Total of all reporting groups
750197|NCT00063258|B2|Baseline|Chemotherapy Alone|
750198|NCT00063258|B1|Baseline|Chemotherapy + Tarceva|
750199|NCT00063258|P2|Participant Flow|Chemotherapy Alone|
750200|NCT00063258|P1|Participant Flow|Chemotherapy + Tarceva|
750201|NCT00063258|O2|Outcome|Chemotherapy Alone|
750202|NCT00063258|O1|Outcome|Chemotherapy + Tarceva|
750203|NCT00063258|E2|Reported Event|Chemotherapy Alone|
750204|NCT00063258|E1|Reported Event|Chemotherapy + Tarceva|
750205|NCT00063154|B1|Baseline|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
750206|NCT00063154|P1|Participant Flow|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
750207|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
750208|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
750209|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
750210|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
750212|NCT00063232|B1|Baseline|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
750213|NCT00063232|P1|Participant Flow|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
750214|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
750215|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
750216|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
750217|NCT00063232|E1|Reported Event|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
750218|NCT00062764|B1|Baseline|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750219|NCT00062764|P1|Participant Flow|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750220|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750221|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750222|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750223|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750224|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750225|NCT00062764|E1|Reported Event|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
750226|NCT00062751|B6|Baseline|Total|Total of all reporting groups
750227|NCT00062751|B5|Baseline|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750228|NCT00062751|B4|Baseline|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750229|NCT00062751|B3|Baseline|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750230|NCT00062751|B2|Baseline|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750231|NCT00062751|B1|Baseline|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750232|NCT00062751|P5|Participant Flow|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750233|NCT00062751|P4|Participant Flow|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750234|NCT00062751|P3|Participant Flow|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750236|NCT00062751|P1|Participant Flow|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750237|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750238|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750239|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750240|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750241|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750242|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750243|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750244|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750245|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750246|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750247|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750248|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750249|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750250|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750251|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750252|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750253|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750254|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750255|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750256|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750257|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750258|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750259|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750260|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750261|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750262|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750263|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750264|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750265|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750266|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750267|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750268|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750269|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750270|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750271|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750272|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750273|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750274|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750275|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750276|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750277|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750278|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750279|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750280|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750281|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750282|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750283|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750284|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750285|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750286|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750287|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750288|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750289|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750290|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750291|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750292|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750293|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750294|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750295|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750296|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750297|NCT00062751|E6|Reported Event|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750298|NCT00062751|E5|Reported Event|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
750299|NCT00062751|E4|Reported Event|After Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). Includes events reported after the cross-over date for cross-over participants.
750300|NCT00062751|E3|Reported Event|Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent (intermit)75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). Includes events reported prior to the cross-over date for cross-over participants.
750301|NCT00062751|E2|Reported Event|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
750302|NCT00062751|E1|Reported Event|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
750303|NCT00062738|B4|Baseline|Total|Total of all reporting groups
750304|NCT00062738|B3|Baseline|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
750305|NCT00062738|B2|Baseline|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
750306|NCT00062738|B1|Baseline|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
750307|NCT00062738|P3|Participant Flow|Placebo|Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion.
750308|NCT00062738|P2|Participant Flow|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. .
750309|NCT00062738|P1|Participant Flow|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
750310|NCT00062738|O3|Outcome|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
750311|NCT00062738|O2|Outcome|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
750312|NCT00062738|O1|Outcome|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
750313|NCT00062738|O3|Outcome|Placebo|
750314|NCT00062738|O2|Outcome|Paroxetine|
750315|NCT00062738|O1|Outcome|Nortriptyline|
750316|NCT00062738|E3|Reported Event|Placebo|
750317|NCT00062738|E2|Reported Event|Paroxetine|
750318|NCT00062738|E1|Reported Event|Nortriptyline|
750319|NCT00062647|B3|Baseline|Total|Total of all reporting groups
750320|NCT00062647|B2|Baseline|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
750321|NCT00062647|B1|Baseline|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
750322|NCT00062647|P2|Participant Flow|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
750323|NCT00062647|P1|Participant Flow|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
750324|NCT00062647|O2|Outcome|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
750325|NCT00062647|O1|Outcome|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
750326|NCT00062647|E2|Reported Event|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
750327|NCT00062647|E1|Reported Event|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
750328|NCT00062439|B1|Baseline|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
750329|NCT00062439|P1|Participant Flow|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
750330|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
750331|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
750332|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
750333|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
750334|NCT00062439|O3|Outcome|Consolidation Docetaxel|
750335|NCT00062439|O2|Outcome|Surgery|
750336|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT|
750337|NCT00062439|E3|Reported Event|Consolidation Docetaxel|
750338|NCT00062439|E2|Reported Event|Surgery|
750339|NCT00062439|E1|Reported Event|Induction Cisplatin/Etoposide + XRT|
750358|NCT00061945|O1|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
750359|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
750360|NCT00061945|E2|Reported Event|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
750919|NCT00056472|E1|Reported Event|Pharmacotherapy|sertraline plus olanzapine
750340|NCT00062374|B1|Baseline|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.~Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.~irinotecan hydrochloride: Given IV~cisplatin: Given IV~conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection~positron emission tomography/computed tomography: Undergo FDG-PET/CT~fludeoxyglucose F 18: Undergo FDG-PET/CT~positron emission tomography/computed tomography: Undergo FLT-PET/CT~fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
750341|NCT00062374|P1|Participant Flow|Arm I|Cisplatin + Irinotecan
750342|NCT00062374|O1|Outcome|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.~Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.~irinotecan hydrochloride: Given IV~cisplatin: Given IV~conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection~positron emission tomography/computed tomography: Undergo FDG-PET/CT~fludeoxyglucose F 18: Undergo FDG-PET/CT~positron emission tomography/computed tomography: Undergo FLT-PET/CT~fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
750343|NCT00062374|O1|Outcome|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.~Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.~irinotecan hydrochloride: Given IV~cisplatin: Given IV~conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection~positron emission tomography/computed tomography: Undergo FDG-PET/CT~fludeoxyglucose F 18: Undergo FDG-PET/CT~positron emission tomography/computed tomography: Undergo FLT-PET/CT~fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
750344|NCT00062374|E1|Reported Event|Arm I|"Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.~Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.~irinotecan hydrochloride: Given IV~cisplatin: Given IV~conventional surgery: Undergo radical subtotal or total gastrectomy with lymph node dissection~positron emission tomography/computed tomography: Undergo FDG-PET/CT~fludeoxyglucose F 18: Undergo FDG-PET/CT~positron emission tomography/computed tomography: Undergo FLT-PET/CT~fluorine F 18 fluorothymidine: Undergo FLT-PET/CT"
750345|NCT00062010|B1|Baseline|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
750346|NCT00062010|P1|Participant Flow|IFN Alpha, 13-Cis-RA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
750347|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
750348|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
750349|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
750350|NCT00062010|E1|Reported Event|IFN Alpha, 13-CRA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
750351|NCT00061945|B3|Baseline|Total|Total of all reporting groups
750352|NCT00061945|B2|Baseline|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
750353|NCT00061945|B1|Baseline|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
750354|NCT00061945|P2|Participant Flow|Phase II - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 & 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 & 29, MTX IV & IT d 1,15 & 19, MTX PO q6 hr d 1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d 3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 & 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
750355|NCT00061945|P1|Participant Flow|Phase I - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 & 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 & 29, MTX IV & IT d1,15 & 19, MTX PO q6 hr d1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 & 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
750356|NCT00061945|O2|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description
750357|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description
750920|NCT00056407|B3|Baseline|Total|Total of all reporting groups
750361|NCT00061945|E1|Reported Event|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
750362|NCT00061932|B3|Baseline|Total|Total of all reporting groups
750363|NCT00061932|B2|Baseline|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
750364|NCT00061932|B1|Baseline|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
750365|NCT00061932|P2|Participant Flow|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
750366|NCT00061932|P1|Participant Flow|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.~bortezomib: Given IV (1.3 mg/m2)~irinotecan: Given IV (125 mg/m2)"
750367|NCT00061932|O2|Outcome|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
750368|NCT00061932|O1|Outcome|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
750369|NCT00061932|E2|Reported Event|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
750370|NCT00061932|E1|Reported Event|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
750371|NCT00061893|B1|Baseline|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
750372|NCT00061893|P1|Participant Flow|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
750373|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
750374|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
750375|NCT00061893|E1|Reported Event|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
750376|NCT00061633|B3|Baseline|Total|Total of all reporting groups
750377|NCT00061633|B2|Baseline|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
750378|NCT00061633|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
750526|NCT00059475|O3|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
750379|NCT00061633|P2|Participant Flow|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
750380|NCT00061633|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
750381|NCT00061633|O2|Outcome|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
750382|NCT00061633|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
750383|NCT00061633|E2|Reported Event|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
750384|NCT00061633|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
750385|NCT00061373|B3|Baseline|Total|Total of all reporting groups
750386|NCT00061373|B2|Baseline|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750387|NCT00061373|B1|Baseline|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750388|NCT00061373|P2|Participant Flow|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750389|NCT00061373|P1|Participant Flow|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750390|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750391|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750392|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750393|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750394|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750395|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750396|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750397|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750398|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750422|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750399|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750400|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750401|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750402|NCT00061373|E2|Reported Event|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750403|NCT00061373|E1|Reported Event|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
750404|NCT00061048|B1|Baseline|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750405|NCT00061048|P1|Participant Flow|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750406|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750407|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750408|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750409|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750410|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750411|NCT00061048|E1|Reported Event|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
750412|NCT00060944|B3|Baseline|Total|Total of all reporting groups
750413|NCT00060944|B2|Baseline|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750414|NCT00060944|B1|Baseline|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750415|NCT00060944|P2|Participant Flow|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750416|NCT00060944|P1|Participant Flow|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750417|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750418|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750419|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750420|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750421|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750423|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750424|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750425|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750426|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750427|NCT00060944|E2|Reported Event|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
750428|NCT00060944|E1|Reported Event|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
750429|NCT00060840|B3|Baseline|Total|Total of all reporting groups
750430|NCT00060840|B2|Baseline|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
750431|NCT00060840|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
750432|NCT00060840|P2|Participant Flow|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
750433|NCT00060840|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
750434|NCT00060840|O2|Outcome|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
750435|NCT00060840|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
750436|NCT00060840|E2|Reported Event|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
750437|NCT00060840|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
750438|NCT00060528|B1|Baseline|Prostate Cancer Patients|Progressive Metastatic Castration Resistant Prostate Cancer
750439|NCT00060528|P4|Participant Flow|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
750440|NCT00060528|P3|Participant Flow|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
750441|NCT00060528|P2|Participant Flow|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
750442|NCT00060528|P1|Participant Flow|no GM|Vaccine subcutaneously with no GM
750443|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
750444|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
750445|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
750446|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms:e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
750447|NCT00060528|O4|Outcome|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
750448|NCT00060528|O3|Outcome|rF-GM (10^7pfu),|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
750449|NCT00060528|O2|Outcome|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
750450|NCT00060528|O1|Outcome|No GM|Vaccine subcutaneously with no GM
750451|NCT00060528|E4|Reported Event|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
750452|NCT00060528|E3|Reported Event|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
750453|NCT00060528|E2|Reported Event|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
750454|NCT00060528|E1|Reported Event|no GM|Vaccine subcutaneously with no GM
750455|NCT00060424|B1|Baseline|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750456|NCT00060424|P1|Participant Flow|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750457|NCT00060424|O1|Outcome|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750458|NCT00060424|O1|Outcome|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750459|NCT00060424|O1|Outcome|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750460|NCT00060424|O1|Outcome|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750461|NCT00060424|O1|Outcome|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750462|NCT00060424|E1|Reported Event|Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant~Total-Body Irradiation: Undergo TBI"
750463|NCT00060346|B1|Baseline|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
750464|NCT00060346|P1|Participant Flow|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
750465|NCT00060346|O1|Outcome|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
750466|NCT00060346|E1|Reported Event|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
750467|NCT00060333|B1|Baseline|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750468|NCT00060333|P1|Participant Flow|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750469|NCT00060333|O3|Outcome|Treatment (Adjuvant Radiation Therapy) Q03|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 3 (Q03) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during the past 24 hours.”
750522|NCT00059475|O7|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
750470|NCT00060333|O2|Outcome|Treatment (Adjuvant Radiation Therapy) Q02|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 2 (Q02) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your USUAL level of fatigue during the past 24 hours.”
750471|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy) Q01|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 1 (Q01) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your fatigue right NOW.”
750472|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750473|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750474|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750475|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750476|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750477|NCT00060333|E1|Reported Event|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
750478|NCT00060008|B1|Baseline|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
750479|NCT00060008|P1|Participant Flow|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
750480|NCT00060008|O2|Outcome|SUVmax >2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
750481|NCT00060008|O1|Outcome|SUVmax < 2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
750482|NCT00060008|E1|Reported Event|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
750483|NCT00059839|B3|Baseline|Total|Total of all reporting groups
750484|NCT00059839|B2|Baseline|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750485|NCT00059839|B1|Baseline|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750523|NCT00059475|O6|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
750486|NCT00059839|P2|Participant Flow|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750487|NCT00059839|P1|Participant Flow|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750488|NCT00059839|O2|Outcome|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750489|NCT00059839|O1|Outcome|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750490|NCT00059839|E2|Reported Event|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750491|NCT00059839|E1|Reported Event|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
750492|NCT00059787|B1|Baseline|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
750493|NCT00059787|P1|Participant Flow|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
750494|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
750524|NCT00059475|O5|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
750495|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
750496|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib~paclitaxel: Given IV~carboplatin: Given IV~erlotinib: Given PO"
750497|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib~paclitaxel: Given IV~carboplatin: Given IV~erlotinib: Given PO"
750498|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
750499|NCT00059787|E1|Reported Event|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
750500|NCT00059475|B9|Baseline|Total|Total of all reporting groups
750501|NCT00059475|B8|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
750502|NCT00059475|B7|Baseline|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
750503|NCT00059475|B6|Baseline|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
750504|NCT00059475|B5|Baseline|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
750505|NCT00059475|B4|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
750506|NCT00059475|B3|Baseline|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
750507|NCT00059475|B2|Baseline|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
750508|NCT00059475|B1|Baseline|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
750509|NCT00059475|P8|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
750510|NCT00059475|P7|Participant Flow|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
750511|NCT00059475|P6|Participant Flow|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
750512|NCT00059475|P5|Participant Flow|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
750513|NCT00059475|P4|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
750514|NCT00059475|P3|Participant Flow|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
750515|NCT00059475|P2|Participant Flow|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
750516|NCT00059475|P1|Participant Flow|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
750517|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
750518|NCT00059475|O3|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
750519|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
750520|NCT00059475|O1|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
750521|NCT00059475|O8|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
750525|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
750527|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
750528|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
750529|NCT00059475|O4|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
750530|NCT00059475|O3|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
750531|NCT00059475|O2|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
750532|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
750533|NCT00059475|E8|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
750534|NCT00059475|E7|Reported Event|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
750535|NCT00059475|E6|Reported Event|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
750536|NCT00059475|E5|Reported Event|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
750537|NCT00059475|E4|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
750538|NCT00059475|E3|Reported Event|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
750539|NCT00059475|E2|Reported Event|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
750540|NCT00059475|E1|Reported Event|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
750541|NCT00059332|B3|Baseline|Total|Total of all reporting groups
750542|NCT00059332|B2|Baseline|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750543|NCT00059332|B1|Baseline|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750544|NCT00059332|P2|Participant Flow|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750545|NCT00059332|P1|Participant Flow|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750546|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750547|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750548|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750549|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750550|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750551|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750552|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750553|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750554|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750555|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750556|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750557|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750594|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
750558|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750559|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750560|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750561|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750562|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750563|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750564|NCT00059332|E2|Reported Event|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
750565|NCT00059332|E1|Reported Event|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
750566|NCT00059215|B5|Baseline|Total|Total of all reporting groups
750567|NCT00059215|B4|Baseline|Clopidogrel|Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day
750568|NCT00059215|B3|Baseline|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
750569|NCT00059215|B2|Baseline|Prasugrel (CS-747) 60 mg LD/10 mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
750570|NCT00059215|B1|Baseline|Prasugrel (CS-747) 40 mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
750571|NCT00059215|P4|Participant Flow|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
750572|NCT00059215|P3|Participant Flow|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
750573|NCT00059215|P2|Participant Flow|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
750574|NCT00059215|P1|Participant Flow|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
750575|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
750576|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
750577|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
750578|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
750579|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
750580|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
750581|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
750582|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
750583|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
750584|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
750585|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
750586|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
750587|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
750588|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
750589|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
750590|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
750591|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
750592|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
750593|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
750595|NCT00059215|E4|Reported Event|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
750596|NCT00059215|E3|Reported Event|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
750597|NCT00059215|E2|Reported Event|Prasugrel (CS-747) 60-mg LD/10 mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
750598|NCT00059215|E1|Reported Event|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
750599|NCT00058825|B1|Baseline|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750600|NCT00058825|P1|Participant Flow|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750601|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
750602|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
750603|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
750604|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
750605|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750606|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750607|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750608|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750609|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750610|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750611|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750612|NCT00058825|E1|Reported Event|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
750613|NCT00058552|B3|Baseline|Total|Total of all reporting groups
750614|NCT00058552|B2|Baseline|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750615|NCT00058552|B1|Baseline|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750616|NCT00058552|P2|Participant Flow|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750617|NCT00058552|P1|Participant Flow|Pertuzumab 420 mg|Participants in this group received pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for Cycle 1 (1 Cycle equals to [=] 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750618|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750619|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab at a loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression (1 Cycle = 3 Weeks).
750620|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750621|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750622|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750623|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750624|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750625|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750626|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750627|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750628|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750629|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750630|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750631|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750632|NCT00058552|E2|Reported Event|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
750633|NCT00058552|E1|Reported Event|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
750634|NCT00058539|B1|Baseline|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750635|NCT00058539|P1|Participant Flow|Pertuzumab|All the participants received a loading dose of 840 milligrams (mg) of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an intravenous (IV) infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750636|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750637|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750658|NCT00058240|O1|Outcome|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
751200|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
750638|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750639|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750640|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750641|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750642|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750643|NCT00058539|E1|Reported Event|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
750644|NCT00058240|B5|Baseline|Total|Total of all reporting groups
750645|NCT00058240|B4|Baseline|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
750646|NCT00058240|B3|Baseline|Dose Level 3|Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
750647|NCT00058240|B2|Baseline|Dose Level 2|Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.
750648|NCT00058240|B1|Baseline|Dose Level 1|Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
750649|NCT00058240|P4|Participant Flow|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
750650|NCT00058240|P3|Participant Flow|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
750651|NCT00058240|P2|Participant Flow|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
750652|NCT00058240|P1|Participant Flow|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
750653|NCT00058240|O1|Outcome|Dose Level 1, 2, 3, 4|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.~Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
750654|NCT00058240|O1|Outcome|Dose Level 4|Flavopiridol was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour beginning Dose Level 2 Cycle 1 for 6 Cycles.
750655|NCT00058240|O4|Outcome|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
750656|NCT00058240|O3|Outcome|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
750657|NCT00058240|O2|Outcome|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
751498|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
750659|NCT00058240|E2|Reported Event|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
750660|NCT00058240|E1|Reported Event|Dose Levels 1-3|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles~Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles~Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
750661|NCT00058214|B1|Baseline|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
750662|NCT00058214|P1|Participant Flow|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
750663|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
750664|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
750665|NCT00058214|E1|Reported Event|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
750666|NCT00058019|B3|Baseline|Total|Total of all reporting groups
750667|NCT00058019|B2|Baseline|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
750668|NCT00058019|B1|Baseline|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
750669|NCT00058019|P2|Participant Flow|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
750670|NCT00058019|P1|Participant Flow|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
750671|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
750672|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
750673|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
750674|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
750675|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
750676|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
750677|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
750678|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
750824|NCT00057551|O3|Outcome|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
750679|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
750680|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
750681|NCT00058019|E1|Reported Event|Ixabeilone for Relapsed Aggressive NHL|
750682|NCT00057954|B1|Baseline|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
750683|NCT00057954|P1|Participant Flow|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
750684|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
750685|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
750686|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
750687|NCT00057954|E1|Reported Event|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
750688|NCT00057941|B3|Baseline|Total|Total of all reporting groups
750689|NCT00057941|B2|Baseline|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
750690|NCT00057941|B1|Baseline|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
750691|NCT00057941|P2|Participant Flow|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
750692|NCT00057941|P1|Participant Flow|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
750693|NCT00057941|O2|Outcome|Fulvestrant and ZD1839|
750694|NCT00057941|O1|Outcome|Anastrozole and ZD1839|
750695|NCT00057941|E2|Reported Event|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
750696|NCT00057941|E1|Reported Event|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
750697|NCT00057876|B3|Baseline|Total|Total of all reporting groups
750698|NCT00057876|B2|Baseline|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
750699|NCT00057876|B1|Baseline|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
750700|NCT00057876|P2|Participant Flow|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
750701|NCT00057876|P1|Participant Flow|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
750702|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
750703|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
750704|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
750705|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
750706|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
750707|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
750708|NCT00057876|E2|Reported Event|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
750709|NCT00057876|E1|Reported Event|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
750710|NCT00057863|B1|Baseline|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
750711|NCT00057863|P1|Participant Flow|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
750712|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
750713|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
750714|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
750715|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
750716|NCT00057863|E1|Reported Event|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
750717|NCT00057837|B3|Baseline|Total|Total of all reporting groups
750718|NCT00057837|B2|Baseline|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
750719|NCT00057837|B1|Baseline|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
750720|NCT00057837|P2|Participant Flow|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
750721|NCT00057837|P1|Participant Flow|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
750722|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
750723|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
750724|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
750725|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
750726|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
750727|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
750825|NCT00057551|O2|Outcome|Brief SP|Supportive Therapy
750728|NCT00057837|E2|Reported Event|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
750729|NCT00057837|E1|Reported Event|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
750730|NCT00057811|B3|Baseline|Total|Total of all reporting groups
750731|NCT00057811|B2|Baseline|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
750732|NCT00057811|B1|Baseline|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
750733|NCT00057811|P2|Participant Flow|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
750734|NCT00057811|P1|Participant Flow|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
750735|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
750736|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
750737|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
750738|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
750739|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
750740|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
750741|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
750742|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
750743|NCT00057811|E2|Reported Event|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
750744|NCT00057811|E1|Reported Event|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
750745|NCT00057785|B1|Baseline|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
750746|NCT00057785|P1|Participant Flow|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
750747|NCT00057785|O1|Outcome|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
750748|NCT00057785|E1|Reported Event|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
750749|NCT00057746|B4|Baseline|Total|Total of all reporting groups
750750|NCT00057746|B3|Baseline|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
750751|NCT00057746|B2|Baseline|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
750752|NCT00057746|B1|Baseline|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
750753|NCT00057746|P3|Participant Flow|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
750754|NCT00057746|P2|Participant Flow|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
750755|NCT00057746|P1|Participant Flow|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
750756|NCT00057746|O3|Outcome|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
750757|NCT00057746|O2|Outcome|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
750758|NCT00057746|O1|Outcome|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
750759|NCT00057746|E3|Reported Event|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
750760|NCT00057746|E2|Reported Event|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
750761|NCT00057746|E1|Reported Event|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
750762|NCT00023673|B4|Baseline|Total|Total of all reporting groups
750826|NCT00057551|O1|Outcome|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
751499|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
750763|NCT00023673|B3|Baseline|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750764|NCT00023673|B2|Baseline|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750765|NCT00023673|B1|Baseline|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750766|NCT00023673|P4|Participant Flow|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750767|NCT00023673|P3|Participant Flow|Phase I: 70 Gy/35 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750768|NCT00023673|P2|Participant Flow|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750769|NCT00023673|P1|Participant Flow|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750770|NCT00023673|O1|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750771|NCT00023673|O2|Outcome|High Grade Toxicity|For lung toxicity, high grade toxicity means >= Grade 3. For esophagitis toxicity, high grade toxicity means >= Grade 2. Therefore overall number of participants analyzed differs.
750772|NCT00023673|O1|Outcome|No High Grade Toxicity|For lung toxicity, no high grade toxicity means < Grade 3. For esophagitis toxicity, no high grade toxicity means < Grade 2. Therefore overall number of participants analyzed differs.
750773|NCT00023673|O2|Outcome|High Grade Toxicity|For lung toxicity, high grade toxicity means >= Grade 3. For esophagitis toxicity, high grade toxicity means >= Grade 2. Therefore overall number of participants analyzed differs.
750774|NCT00023673|O1|Outcome|No High Grade Toxicity|For lung toxicity, no high grade toxicity means < Grade 3. For esophagitis toxicity, no high grade toxicity means < Grade 2. Therefore overall number of participants analyzed differs.
750775|NCT00023673|O1|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750776|NCT00023673|O1|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.~carboplatin~paclitaxel~three-dimensional conformal radiation therapy"
750777|NCT00023673|O2|Outcome|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750778|NCT00023673|O1|Outcome|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750779|NCT00023673|E2|Reported Event|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750780|NCT00023673|E1|Reported Event|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
750781|NCT00057681|B4|Baseline|Total|Total of all reporting groups
750827|NCT00057551|E3|Reported Event|Medication|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
750828|NCT00057551|E2|Reported Event|BriefSP|Supportive Therapy
750829|NCT00057551|E1|Reported Event|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
750830|NCT00057330|B3|Baseline|Total|Total of all reporting groups
750782|NCT00057681|B3|Baseline|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
750783|NCT00057681|B2|Baseline|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
750784|NCT00057681|B1|Baseline|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
750785|NCT00057681|P3|Participant Flow|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
750786|NCT00057681|P2|Participant Flow|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
750787|NCT00057681|P1|Participant Flow|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
750788|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
750789|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
750790|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
750791|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
750792|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
750793|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
750794|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
751244|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
750795|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
750796|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
750797|NCT00057681|E3|Reported Event|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
750798|NCT00057681|E2|Reported Event|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
750799|NCT00057681|E1|Reported Event|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
750800|NCT00057577|B3|Baseline|Total|Total of all reporting groups
750801|NCT00057577|B2|Baseline|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750802|NCT00057577|B1|Baseline|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750803|NCT00057577|P2|Participant Flow|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750804|NCT00057577|P1|Participant Flow|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750805|NCT00057577|O2|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750831|NCT00057330|B2|Baseline|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750832|NCT00057330|B1|Baseline|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750921|NCT00056407|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750806|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750807|NCT00057577|O4|Outcome|Prior Meds Withdrawn|Patients who recovered on medication treatment were withdrawn from medications
750808|NCT00057577|O3|Outcome|Prioir Meds Maintained|Patients who recovered on medication treatment were maintained on medications
750809|NCT00057577|O2|Outcome|Prior CBT + Meds Withdrawn|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and withdrawn from medications
750810|NCT00057577|O1|Outcome|Prior CBT + Meds Maintained|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and maintained on medications
750811|NCT00057577|O2|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750812|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750813|NCT00057577|O2|Outcome|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750814|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750815|NCT00057577|E2|Reported Event|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750816|NCT00057577|E1|Reported Event|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
750817|NCT00057551|B4|Baseline|Total|Total of all reporting groups
750818|NCT00057551|B3|Baseline|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
750819|NCT00057551|B2|Baseline|Brief Supportive P|Brief Supportive Psychotherapyherapy
750820|NCT00057551|B1|Baseline|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
750821|NCT00057551|P3|Participant Flow|Medication Only|"An algorithm including Sertraline, Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
750822|NCT00057551|P2|Participant Flow|BriefSP|Brief Supportive Psychotherapy
750823|NCT00057551|P1|Participant Flow|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
750833|NCT00057330|P2|Participant Flow|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750834|NCT00057330|P1|Participant Flow|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750835|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750836|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750837|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750838|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750839|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750840|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750841|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750842|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750843|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750844|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750845|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750846|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750847|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750848|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750849|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750850|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750851|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750852|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750853|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750854|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750855|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750856|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750857|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750858|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750910|NCT00056472|P2|Participant Flow|Olanzapine Plus Placebo|5-20mg/day olanzapine plus placebo
750859|NCT00057330|E2|Reported Event|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750860|NCT00057330|E1|Reported Event|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
750861|NCT00056862|B3|Baseline|Total|Total of all reporting groups
750862|NCT00056862|B2|Baseline|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750863|NCT00056862|B1|Baseline|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750864|NCT00056862|P2|Participant Flow|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750865|NCT00056862|P1|Participant Flow|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750866|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750867|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750868|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750869|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750870|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750871|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750872|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750873|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750874|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750875|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750876|NCT00056862|E2|Reported Event|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
750877|NCT00056862|E1|Reported Event|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
750878|NCT00056563|B3|Baseline|Total|Total of all reporting groups
750911|NCT00056472|P1|Participant Flow|Sertraline Plus Olanzapine|50-200mg/day sertraline plus 5-20mg/day olanzapine
750912|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
750879|NCT00056563|B2|Baseline|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
750880|NCT00056563|B1|Baseline|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
750881|NCT00056563|P2|Participant Flow|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
750882|NCT00056563|P1|Participant Flow|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
750883|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
750884|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
750885|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
750886|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
750887|NCT00056563|E2|Reported Event|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
750888|NCT00056563|E1|Reported Event|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
750889|NCT00056550|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
750890|NCT00056550|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin(AT)deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with recombinant human antithrombin (rhAT) was individualized with an initial intravenous loading dose, followed by a continuous intravenous infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80% and <120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments were based on the results of AT activity level determinations performed prior to and during the treatment.
750891|NCT00056550|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal.
750892|NCT00056550|O1|Outcome|Recombinant Human Antithombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin (AT) deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80 and < 120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
750893|NCT00056550|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
750894|NCT00056498|B3|Baseline|Total|Total of all reporting groups
750895|NCT00056498|B2|Baseline|Placebo|Participants assigned to placebo
750896|NCT00056498|B1|Baseline|Risperidone|Participants assigned to risperidone
750897|NCT00056498|P2|Participant Flow|Placebo|Participants assigned to placebo
750898|NCT00056498|P1|Participant Flow|Risperidone|Participants assigned to risperidone
750899|NCT00056498|O2|Outcome|Placebo|Participants assigned to placebo
750900|NCT00056498|O1|Outcome|Risperidone|Participants assigned to risperidone
750901|NCT00056498|O2|Outcome|Placebo|Participants assigned to placebo
750902|NCT00056498|O1|Outcome|Risperidone|Participants assigned to risperidone
750903|NCT00056498|O2|Outcome|Placebo|Participants assigned to placebo
750904|NCT00056498|O1|Outcome|Risperidone|Participants assigned to risperidone
750905|NCT00056498|E2|Reported Event|Placebo|Participants assigned to placebo
750906|NCT00056498|E1|Reported Event|Risperidone|Participants assigned to risperidone
750907|NCT00056472|B3|Baseline|Total|Total of all reporting groups
750908|NCT00056472|B2|Baseline|Monotherapy|placebo plus olanzapine
750909|NCT00056472|B1|Baseline|Pharmacotherapy|sertraline plus olanzapine
750922|NCT00056407|B1|Baseline|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750923|NCT00056407|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750924|NCT00056407|P1|Participant Flow|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750925|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750926|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750927|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750928|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750929|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750930|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750931|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750932|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750933|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750934|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750935|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750936|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750937|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750938|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750939|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750940|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750941|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750942|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750943|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750944|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750945|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750946|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750947|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750948|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750949|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750950|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750951|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750952|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750953|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750954|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750955|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750956|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750957|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750958|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750959|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750960|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750961|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750962|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750963|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750964|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750965|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750966|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750967|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750968|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750969|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750970|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750971|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750972|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750973|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750974|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750975|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750976|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750977|NCT00056407|E2|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
750978|NCT00056407|E1|Reported Event|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
750979|NCT00056316|B3|Baseline|Total|Total of all reporting groups
750980|NCT00056316|B2|Baseline|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
750981|NCT00056316|B1|Baseline|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
750982|NCT00056316|P2|Participant Flow|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
750983|NCT00056316|P1|Participant Flow|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
750984|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
750985|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
750986|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
750987|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
750988|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
750989|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
750990|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
750991|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
750992|NCT00056316|E2|Reported Event|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
750993|NCT00056316|E1|Reported Event|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
750994|NCT00056160|B3|Baseline|Total|Total of all reporting groups
750995|NCT00056160|B2|Baseline|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
750996|NCT00056160|B1|Baseline|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
750997|NCT00056160|P2|Participant Flow|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
750998|NCT00056160|P1|Participant Flow|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
750999|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
751000|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
751001|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
751002|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
751003|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
751004|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
751005|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
751006|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
751007|NCT00056160|E2|Reported Event|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
751008|NCT00056160|E1|Reported Event|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
751156|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751009|NCT00055692|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751010|NCT00055692|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751011|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751012|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751013|NCT00055692|O2|Outcome|Treatment (Bevacizumab): 8 Weeks|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751014|NCT00055692|O1|Outcome|Treatment (Bevacizumab): Baseline|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751015|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751016|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751017|NCT00055692|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
751018|NCT00055601|B3|Baseline|Total|Total of all reporting groups
751019|NCT00055601|B2|Baseline|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751020|NCT00055601|B1|Baseline|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751021|NCT00055601|P2|Participant Flow|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751022|NCT00055601|P1|Participant Flow|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751023|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751024|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751025|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751026|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751027|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751028|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751029|NCT00055601|E2|Reported Event|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751030|NCT00055601|E1|Reported Event|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
751031|NCT00055497|B5|Baseline|Total|Total of all reporting groups
751032|NCT00055497|B4|Baseline|OL Adalimumab 40 mg Eow|Participants who did not continue at Week 4 are not included in Baseline summary.
751033|NCT00055497|B3|Baseline|DB Adalimumab 40 mg Every Week|
751034|NCT00055497|B2|Baseline|DB Adalimumab 40 mg Every Other Week (Eow)|
751035|NCT00055497|B1|Baseline|DB Placebo|
751036|NCT00055497|P4|Participant Flow|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week.
751037|NCT00055497|P3|Participant Flow|DB Adalimumab 40 mg Every Week (ew)|Double-blind adalimumab 40 mg every week.
751038|NCT00055497|P2|Participant Flow|DB Adalimumab 40 mg Every Other Week (Eow)|Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
751039|NCT00055497|P1|Participant Flow|DB Placebo|Double-blind adalimumab placebo every week.
751040|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
751041|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
751042|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
751043|NCT00055497|O1|Outcome|DB Placebo|
751044|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
751045|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
751046|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
751047|NCT00055497|O1|Outcome|DB Placebo|
751048|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
751049|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
751050|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
751051|NCT00055497|O1|Outcome|DB Placebo|
751052|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|
751053|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
751054|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
751055|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
751056|NCT00055497|O1|Outcome|DB Placebo|
751057|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
751058|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
751059|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
751060|NCT00055497|O1|Outcome|DB Placebo|
751061|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
751062|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
751063|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
751064|NCT00055497|O1|Outcome|DB Placebo|
751065|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
751066|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
751067|NCT00055497|O1|Outcome|DB Placebo|
751068|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
751069|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
751070|NCT00055497|O1|Outcome|Placebo|
751071|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week
751072|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
751073|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
751074|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
751075|NCT00055497|O1|Outcome|DB Placebo|
751076|NCT00055497|E4|Reported Event|OL Adalimumab 40 mg|
751077|NCT00055497|E3|Reported Event|DB Adalimumab 40 mg ew|
751078|NCT00055497|E2|Reported Event|DB Adalimumab 40 mg Eow|
751079|NCT00055497|E1|Reported Event|DB Placebo|
751080|NCT00055471|B4|Baseline|Total|Total of all reporting groups
751081|NCT00055471|B3|Baseline|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751082|NCT00055471|B2|Baseline|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751083|NCT00055471|B1|Baseline|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751084|NCT00055471|P3|Participant Flow|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751085|NCT00055471|P2|Participant Flow|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751086|NCT00055471|P1|Participant Flow|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751087|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751088|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751089|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751090|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751091|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751092|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751093|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751094|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751095|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751096|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751097|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751098|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751099|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751100|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751101|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751102|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751103|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751104|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751105|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751106|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751107|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751108|NCT00055471|E3|Reported Event|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
751109|NCT00055471|E2|Reported Event|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
751110|NCT00055471|E1|Reported Event|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
751111|NCT00055237|B3|Baseline|Total|Total of all reporting groups
751112|NCT00055237|B2|Baseline|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
751113|NCT00055237|B1|Baseline|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
751114|NCT00055237|P2|Participant Flow|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
751115|NCT00055237|P1|Participant Flow|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
751116|NCT00055237|O1|Outcome|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
751117|NCT00055237|O1|Outcome|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
751118|NCT00055237|E1|Reported Event|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
751119|NCT00054847|B3|Baseline|Total|Total of all reporting groups
751120|NCT00054847|B2|Baseline|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
751121|NCT00054847|B1|Baseline|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
751122|NCT00054847|P2|Participant Flow|Radial Artery Graft|"Radial Artery Graft~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
751123|NCT00054847|P1|Participant Flow|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
751124|NCT00054847|O2|Outcome|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
751125|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
751126|NCT00054847|O2|Outcome|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
751127|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
751128|NCT00054847|O2|Outcome|Radial Artery Grafts|"Radial Artery Grafts~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
751129|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
751130|NCT00054847|O2|Outcome|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
751131|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
751132|NCT00054847|E2|Reported Event|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
751133|NCT00054847|E1|Reported Event|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
751134|NCT00054717|B3|Baseline|Total|Total of all reporting groups
751135|NCT00054717|B2|Baseline|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751136|NCT00054717|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751137|NCT00054717|P2|Participant Flow|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751138|NCT00054717|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751139|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751140|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751141|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751142|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751143|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751144|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751145|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751146|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751147|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751148|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751149|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751150|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751151|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751152|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751153|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751154|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751155|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751157|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751158|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751159|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751160|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751161|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751162|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751163|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751164|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751165|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751166|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751167|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751168|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751169|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751170|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751171|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751172|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751173|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751174|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751175|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751176|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751177|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751178|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751179|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751180|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751181|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751182|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751183|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751184|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751185|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751186|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751187|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751188|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751189|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751190|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751191|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751192|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751193|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751194|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751195|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751196|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751197|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751198|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751199|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751201|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751202|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751203|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751204|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751205|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751206|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751207|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751208|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751209|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751210|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751211|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751212|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751213|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751214|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751215|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751216|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751217|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751218|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751219|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751220|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751221|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751222|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751223|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751224|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751225|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751226|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751227|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751228|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751229|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751230|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751231|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751232|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751233|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751234|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751235|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751236|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751237|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751238|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751239|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751240|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751241|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751242|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751243|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751245|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751246|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751247|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751248|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751249|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751250|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751251|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751252|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751253|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751254|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751255|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751256|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751257|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751258|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751259|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751260|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751261|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751262|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751263|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751264|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751265|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751266|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751267|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751268|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751269|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751270|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751271|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751272|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751273|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751274|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751275|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751276|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751277|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751278|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751279|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751280|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751281|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751282|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751283|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751284|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751285|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751286|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751287|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751288|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751289|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751290|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751291|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751292|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751293|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751294|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751295|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751296|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751297|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751298|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751299|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751300|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751301|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751302|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751303|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751304|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751305|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751306|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751307|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751308|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751309|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751310|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751311|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751312|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751313|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751314|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751315|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751316|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751317|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751318|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751319|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751320|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751321|NCT00054717|E2|Reported Event|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
751322|NCT00054717|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
751323|NCT00054704|B3|Baseline|Total|Total of all reporting groups
751324|NCT00054704|B2|Baseline|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751339|NCT00054665|P1|Participant Flow|Part A: PS-341 Alone|1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
751394|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751325|NCT00054704|B1|Baseline|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751326|NCT00054704|P2|Participant Flow|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751327|NCT00054704|P1|Participant Flow|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751328|NCT00054704|O2|Outcome|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751329|NCT00054704|O1|Outcome|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751330|NCT00054704|E2|Reported Event|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751331|NCT00054704|E1|Reported Event|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
751332|NCT00054691|B1|Baseline|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
751333|NCT00054691|P1|Participant Flow|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
751334|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
751335|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
751336|NCT00054691|E1|Reported Event|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
751337|NCT00054665|B1|Baseline|Arm A & B: PS-341 and PS-341 & EPOCH|"Part A: PS-341 Alone~1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 & EPOCH~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days"
751338|NCT00054665|P2|Participant Flow|Part B: PS-341 & EPOCH|PS-341 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m^2 intravenous bolus day 5, prednisone 60 mg/m^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery >/= 5000/mm^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
751494|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751340|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"Part B:~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
751341|NCT00054665|O1|Outcome|Part A: PS-341 Alone|Part A: 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
751342|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
751343|NCT00054665|O1|Outcome|Part A: PS-341 Alone|1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
751344|NCT00054665|E2|Reported Event|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days."
751345|NCT00054665|E1|Reported Event|Part A: PS-341 Alone|PS-341 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
751346|NCT00054639|B1|Baseline|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
751347|NCT00054639|P1|Participant Flow|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
751348|NCT00054639|O1|Outcome|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
751349|NCT00054639|E1|Reported Event|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
751350|NCT00054353|B3|Baseline|Total|Total of all reporting groups
751351|NCT00054353|B2|Baseline|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751352|NCT00054353|B1|Baseline|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751353|NCT00054353|P2|Participant Flow|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751385|NCT00054327|P1|Participant Flow|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751386|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751387|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751354|NCT00054353|P1|Participant Flow|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751355|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751356|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751357|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751358|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751359|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751360|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751388|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751389|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751390|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
751361|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751362|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751363|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751364|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751365|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751366|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751367|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative studies"
751391|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751392|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751393|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751368|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative studies"
751369|NCT00054353|O2|Outcome|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751370|NCT00054353|O1|Outcome|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~laboratory biomarker analysis: Correlative s"
751371|NCT00054353|E2|Reported Event|Unrelated Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s"
751372|NCT00054353|E1|Reported Event|Related Donor|"PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors).~fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT~peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s"
751373|NCT00054327|B7|Baseline|Total|Total of all reporting groups
751374|NCT00054327|B6|Baseline|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751375|NCT00054327|B5|Baseline|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751376|NCT00054327|B4|Baseline|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751377|NCT00054327|B3|Baseline|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751378|NCT00054327|B2|Baseline|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.
751379|NCT00054327|B1|Baseline|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751380|NCT00054327|P6|Participant Flow|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751381|NCT00054327|P5|Participant Flow|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751382|NCT00054327|P4|Participant Flow|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751383|NCT00054327|P3|Participant Flow|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751384|NCT00054327|P2|Participant Flow|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
751395|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751396|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
751397|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751398|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751399|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751400|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751401|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751402|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
751403|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751404|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751405|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751406|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751407|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751408|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
751409|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751410|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751411|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751412|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751413|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751414|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
751415|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751416|NCT00054327|E6|Reported Event|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
751417|NCT00054327|E5|Reported Event|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
751418|NCT00054327|E4|Reported Event|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
751419|NCT00054327|E3|Reported Event|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
751420|NCT00054327|E2|Reported Event|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
751421|NCT00054327|E1|Reported Event|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
751422|NCT00054275|B1|Baseline|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
751423|NCT00054275|P1|Participant Flow|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
751424|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
751425|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
751426|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
751427|NCT00054275|E1|Reported Event|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
751495|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751496|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751428|NCT00054132|B1|Baseline|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
751429|NCT00054132|P1|Participant Flow|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
751430|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|"Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
751431|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|"Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Erlotinib Hydrochloride: Given PO~Laboratory Biomarker Analysis: Correlative studies"
751432|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
751433|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
751434|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
751435|NCT00054132|O1|Outcome|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
751436|NCT00054132|E1|Reported Event|Treatment (Erlotinib Hydrochloride, Bevacizumab)|Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
751437|NCT00054028|B3|Baseline|Total|Total of all reporting groups
751438|NCT00054028|B2|Baseline|Suramin and Paclitaxel (Phase II)|Patients receive paclitaxel in combination with the target dose of suramin.
751439|NCT00054028|B1|Baseline|Suramin and Paclitaxel (Phase I)|Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.
751440|NCT00054028|P1|Participant Flow|Treatment (Suramin and Paclitaxel)|"PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.~PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above."
751441|NCT00054028|O1|Outcome|Treatment (Suramin and Paclitaxel)|PHASE II: Patients receive paclitaxel in combination with the target dose of suramin the same as Phase I.
751442|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
751443|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
751444|NCT00054028|E1|Reported Event|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
751445|NCT00053898|B3|Baseline|Total|Total of all reporting groups
751446|NCT00053898|B2|Baseline|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~Drug: anastrozole~1 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
751447|NCT00053898|B1|Baseline|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~Drug: tamoxifen citrate~20 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
751448|NCT00053898|P2|Participant Flow|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751449|NCT00053898|P1|Participant Flow|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751450|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751451|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751452|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751453|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751454|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751497|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751455|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751456|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751457|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751458|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751459|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751460|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751461|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751462|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751463|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751464|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751465|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751466|NCT00053898|O2|Outcome|Group 2: Anastrozole + Tamoxifen Placebo|"anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years~anastrozole: 1 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751467|NCT00053898|O1|Outcome|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~tamoxifen citrate: 20 mg/day and placebo for 5 years~Radiation Therapy: Adjuvant radiation therapy"
751468|NCT00053898|E2|Reported Event|Group 2: Anastrazole + Tamoxifen Placebo|"anastrozole, 1 mg/day and a tamoxifen look-alike placebo for 5 years~Drug: anastrozole~1 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
751469|NCT00053898|E1|Reported Event|Group 1: Tamoxifen + Anastrozole Placebo|"tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years~Drug: tamoxifen citrate~20 mg/day and placebo for 5 years~Radiation: Radiation Therapy~Adjuvant radiation therapy"
751470|NCT00053846|B3|Baseline|Total|Total of all reporting groups
751471|NCT00053846|B2|Baseline|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
751472|NCT00053846|B1|Baseline|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
751473|NCT00053846|P2|Participant Flow|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
751474|NCT00053846|P1|Participant Flow|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
751475|NCT00053846|O2|Outcome|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
751476|NCT00053846|O1|Outcome|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
751477|NCT00053846|E2|Reported Event|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
751478|NCT00053846|E1|Reported Event|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
751479|NCT00053703|B4|Baseline|Total|Total of all reporting groups
751480|NCT00053703|B3|Baseline|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751481|NCT00053703|B2|Baseline|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751482|NCT00053703|B1|Baseline|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751483|NCT00053703|P3|Participant Flow|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751484|NCT00053703|P2|Participant Flow|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751485|NCT00053703|P1|Participant Flow|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751486|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751487|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751488|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751489|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751490|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751491|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751492|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751493|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751500|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751501|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751502|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751503|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751504|NCT00053703|E3|Reported Event|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
751505|NCT00053703|E2|Reported Event|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
751506|NCT00053703|E1|Reported Event|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
751507|NCT00053677|B3|Baseline|Total|Total of all reporting groups
751508|NCT00053677|B2|Baseline|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
751509|NCT00053677|B1|Baseline|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
751510|NCT00053677|P2|Participant Flow|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
751511|NCT00053677|P1|Participant Flow|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
751512|NCT00053677|O2|Outcome|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
751513|NCT00053677|O1|Outcome|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
751514|NCT00053677|E2|Reported Event|Placebo|"Subjects who were assigned to placebo in the 17 week double-blind phase.~Placebo: For subjects who were randomly assigned to placebo."
751515|NCT00053677|E1|Reported Event|Naltrexone|"17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.~Naltrexone: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day."
751516|NCT00053495|B6|Baseline|Total|Total of all reporting groups
751517|NCT00053495|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751518|NCT00053495|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751519|NCT00053495|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751520|NCT00053495|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751521|NCT00053495|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751522|NCT00053495|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751523|NCT00053495|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751524|NCT00053495|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751525|NCT00053495|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751526|NCT00053495|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751527|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751528|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751529|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751530|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751531|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751532|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751533|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751534|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751895|NCT00046891|B1|Baseline|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
751535|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751536|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751537|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751538|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751539|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751540|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751541|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751542|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751543|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751544|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751545|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751546|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751547|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751548|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751549|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751550|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751551|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751552|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751553|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751554|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751555|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751556|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751557|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751558|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751559|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751560|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751561|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751562|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751563|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751564|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751565|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751566|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751567|NCT00053495|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751568|NCT00053495|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
751569|NCT00053495|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
751570|NCT00053495|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
751571|NCT00053495|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
751572|NCT00053482|B6|Baseline|Total|Total of all reporting groups
751573|NCT00053482|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751574|NCT00053482|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751575|NCT00053482|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751576|NCT00053482|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751577|NCT00053482|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751896|NCT00046891|P2|Participant Flow|Placebo|Placebo: Patients will take 1 tablet BID
751578|NCT00053482|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751579|NCT00053482|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751580|NCT00053482|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751581|NCT00053482|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751582|NCT00053482|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751583|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751584|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751585|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751586|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751587|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751588|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751589|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751590|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751591|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751592|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751593|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751594|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751595|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751596|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751597|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751598|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751599|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751600|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751601|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751602|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751603|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751604|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751605|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751606|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751607|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751608|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751609|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751610|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751611|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751612|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751613|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751614|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751615|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751616|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751617|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751618|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751619|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751620|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751621|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751622|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751623|NCT00053482|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751624|NCT00053482|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
751625|NCT00053482|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
751626|NCT00053482|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
751627|NCT00053482|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
751628|NCT00053417|B5|Baseline|Total|Total of all reporting groups
751629|NCT00053417|B4|Baseline|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
751630|NCT00053417|B3|Baseline|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
751631|NCT00053417|B2|Baseline|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
751632|NCT00053417|B1|Baseline|Placebo|Placebo control
751633|NCT00053417|P4|Participant Flow|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
751634|NCT00053417|P3|Participant Flow|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
751635|NCT00053417|P2|Participant Flow|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
751636|NCT00053417|P1|Participant Flow|Placebo|Placebo control
751637|NCT00053417|O4|Outcome|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
751638|NCT00053417|O3|Outcome|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
751639|NCT00053417|O2|Outcome|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
751640|NCT00053417|O1|Outcome|Placebo|Placebo control
751641|NCT00053417|E4|Reported Event|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
751642|NCT00053417|E3|Reported Event|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
751643|NCT00053417|E2|Reported Event|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
751644|NCT00053417|E1|Reported Event|Placebo|Placebo control
751645|NCT00053365|B1|Baseline|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
751646|NCT00053365|P1|Participant Flow|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
751647|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
751648|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
751649|NCT00053365|O2|Outcome|Grade 4 (CTCAE v 2.0)|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
751650|NCT00053365|O1|Outcome|Grade 3 (CTCAE v 2.0)|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
751651|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
751652|NCT00053365|E1|Reported Event|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
751653|NCT00053352|B3|Baseline|Total|Total of all reporting groups
751654|NCT00053352|B2|Baseline|Arm 2|No intervention
751655|NCT00053352|B1|Baseline|Arm I|Experimental
751656|NCT00053352|P2|Participant Flow|Arm 2|No intervention
751657|NCT00053352|P1|Participant Flow|Arm I|Experimental
751658|NCT00053352|O1|Outcome|Arm I|Experimental
751659|NCT00053352|O1|Outcome|Arm I|Experimental
751660|NCT00053352|O2|Outcome|Arm 2|No intervention
751661|NCT00053352|O1|Outcome|Arm I|Experimental
751662|NCT00053352|O1|Outcome|Arm 1|Experimental
751663|NCT00053352|E2|Reported Event|Arm I (Chemotherapy)|"Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes & etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 & 6).~After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (2nd-look) and/or 3 more courses of compressed consolidation chemotherapy.~After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.~Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, & 16.~con"
751664|NCT00053352|E1|Reported Event|Arm 2 (Observation)|"Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm.~Observation only for recurrence or development of an SMN"
751665|NCT00053014|B1|Baseline|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
751666|NCT00053014|P1|Participant Flow|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
751667|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
751668|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
751669|NCT00053014|E1|Reported Event|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
751670|NCT00003830|B3|Baseline|Total|Total of all reporting groups
751671|NCT00003830|B2|Baseline|Sentinel Node Resection Followed by Node Examination|Sentinel node resection followed by node examination
751672|NCT00003830|B1|Baseline|Conventional Axillary Dissection|Sentinel Node Resection Followed by Conventional Axillary Dissection
751673|NCT00003830|P2|Participant Flow|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751674|NCT00003830|P1|Participant Flow|Arm I: Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751675|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751676|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751677|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751678|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751679|NCT00003830|O2|Outcome|Group 2: Negative Node Patients With Occult Metastases|Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
751680|NCT00003830|O1|Outcome|Group 1: Negative Node Patients Without Occult Metastases|Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
751681|NCT00003830|O2|Outcome|Group 2: Negative Node Patients With Occult Metastases|Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
751682|NCT00003830|O1|Outcome|Group 1: Negative Node Patients Without Occult Metastases|Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
751683|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751684|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751685|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751686|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751687|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751688|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751689|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751690|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751691|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751692|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751693|NCT00003830|O2|Outcome|Arm II: Sentinel Node Resection Followed by Node Examination|"Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.~Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node."
751694|NCT00003830|O1|Outcome|Arm I:Sentinel Node Resection+Conventional Axillary Dissection|"Sentinel node resection immediately followed by axillary dissection~conventional surgery: Sentinel node resection immediately followed by axillary dissection."
751695|NCT00003830|E2|Reported Event|Sentinel Node Resection Followed by Node Examination|Sentinel node resection followed by node examination
751696|NCT00003830|E1|Reported Event|Conventional Axillary Dissection|Conventional axillary dissection
751697|NCT00052962|B3|Baseline|Total|Total of all reporting groups
751698|NCT00052962|B2|Baseline|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751699|NCT00052962|B1|Baseline|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751700|NCT00052962|P2|Participant Flow|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751701|NCT00052962|P1|Participant Flow|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751702|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751703|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751704|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751705|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751706|NCT00052962|E2|Reported Event|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751707|NCT00052962|E1|Reported Event|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
751708|NCT00052715|B1|Baseline|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
751709|NCT00052715|P1|Participant Flow|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
751710|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
751711|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
751712|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
751713|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
751714|NCT00052715|E1|Reported Event|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
751897|NCT00046891|P1|Participant Flow|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
751715|NCT00052429|B1|Baseline|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
751716|NCT00052429|P1|Participant Flow|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
751717|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
751718|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
751719|NCT00052429|E1|Reported Event|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
751720|NCT00049543|B3|Baseline|Total|Total of all reporting groups
751721|NCT00049543|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
751722|NCT00049543|B1|Baseline|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
751723|NCT00049543|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
751724|NCT00049543|P1|Participant Flow|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
751725|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
751726|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
751727|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
751728|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
751729|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
751730|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
751731|NCT00049543|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
751732|NCT00049543|E1|Reported Event|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
751782|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
751733|NCT00049530|B1|Baseline|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
751734|NCT00049530|P1|Participant Flow|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
751735|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
751736|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
751737|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
751738|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
751739|NCT00049530|E1|Reported Event|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
751740|NCT00049517|B3|Baseline|Total|Total of all reporting groups
751741|NCT00049517|B2|Baseline|High Dose Daunorubicin (Induction Therapy)|Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
751742|NCT00049517|B1|Baseline|Standard Daunorubicin (Induction Therapy)|"Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.~Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course."
751743|NCT00049517|P6|Participant Flow|High-dose Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
751744|NCT00049517|P5|Participant Flow|Standard Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
751745|NCT00049517|P4|Participant Flow|High-dose Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
751746|NCT00049517|P3|Participant Flow|Standard Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
751747|NCT00049517|P2|Participant Flow|High-dose Daunorubicin Then Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
751748|NCT00049517|P1|Participant Flow|Standard Daunorubicin Then Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
751749|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
751750|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
751751|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
751752|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
751753|NCT00049517|O2|Outcome|High-dose Daunorubicin|Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
751754|NCT00049517|O1|Outcome|Standard Daunorubicin|Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
751755|NCT00049517|E2|Reported Event|High Dose Daunorubicin (Induction Therapy)|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.~Conditioning/Transplant:~Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I."
751756|NCT00049517|E1|Reported Event|Standard Daunorubicin (Induction Therapy)|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Conditioning/Transplant:~Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover."
751757|NCT00049504|B1|Baseline|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
751758|NCT00049504|P1|Participant Flow|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
751759|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
751760|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
751898|NCT00046891|O3|Outcome|Make Decisions|Self-report cognition
751761|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
751762|NCT00049504|E1|Reported Event|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
751763|NCT00049322|B3|Baseline|Total|Total of all reporting groups
751764|NCT00049322|B2|Baseline|Arm II (TACE-O Arm )|Observation
751765|NCT00049322|B1|Baseline|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751766|NCT00049322|P2|Participant Flow|Arm II (TACE-O Arm )|Observation
751767|NCT00049322|P1|Participant Flow|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751768|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751769|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751770|NCT00049322|O2|Outcome|Arm II-chemoembolization|chemoembolization as part of standard of care
751771|NCT00049322|O1|Outcome|Arm I-bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751772|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
751773|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751774|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
751775|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751776|NCT00049322|E2|Reported Event|Arm II|Patients do not receive bevacizumab
751777|NCT00049322|E1|Reported Event|Arm I|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
751778|NCT00049257|B1|Baseline|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
751779|NCT00049257|P1|Participant Flow|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
751780|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
751781|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
751783|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
751784|NCT00049257|E1|Reported Event|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
751785|NCT00049127|B6|Baseline|Total|Total of all reporting groups
751786|NCT00049127|B5|Baseline|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
751787|NCT00049127|B4|Baseline|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
751788|NCT00049127|B3|Baseline|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
751789|NCT00049127|B2|Baseline|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
751790|NCT00049127|B1|Baseline|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
751791|NCT00049127|P5|Participant Flow|Study 3 Arm E|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at 300 mg b.i.d."
751792|NCT00049127|P4|Participant Flow|Study 3 Arm D|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
751793|NCT00049127|P3|Participant Flow|Study 2 Arm B|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at 300 mg b.i.d."
751794|NCT00049127|P2|Participant Flow|Study 2 Arm A|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
751795|NCT00049127|P1|Participant Flow|Study 1 Arm C|"Phase I patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses."
751796|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
751797|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
751798|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
751799|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
751800|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
751801|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
751802|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
751803|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
751804|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
751805|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
751806|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
751807|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
751808|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
751809|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
751810|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
751811|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
751812|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
751813|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
751814|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
751815|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
751816|NCT00049127|E5|Reported Event|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
751817|NCT00049127|E4|Reported Event|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
751818|NCT00049127|E3|Reported Event|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
751819|NCT00049127|E2|Reported Event|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
751820|NCT00049127|E1|Reported Event|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
751821|NCT00049036|B3|Baseline|Total|Total of all reporting groups
751822|NCT00049036|B2|Baseline|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
751823|NCT00049036|B1|Baseline|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
751824|NCT00049036|P2|Participant Flow|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
751825|NCT00049036|P1|Participant Flow|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
751826|NCT00049036|O2|Outcome|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
751827|NCT00049036|O1|Outcome|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
751828|NCT00049036|E2|Reported Event|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
751829|NCT00049036|E1|Reported Event|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
751830|NCT00048997|B3|Baseline|Total|Total of all reporting groups
751831|NCT00048997|B2|Baseline|Observation|Observation.
751832|NCT00048997|B1|Baseline|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
751833|NCT00048997|P2|Participant Flow|Observation|Observation
751834|NCT00048997|P1|Participant Flow|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
751835|NCT00048997|O2|Outcome|Observation|Observation
751836|NCT00048997|O1|Outcome|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
751837|NCT00048997|E1|Reported Event|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy..
751838|NCT00047385|B3|Baseline|Total|Total of all reporting groups
751839|NCT00047385|B2|Baseline|Chest X-ray|Participants undergo chest x-ray examination.
751840|NCT00047385|B1|Baseline|Low-Dose CT|Participants undergo low-dose helical CT examination.
751841|NCT00047385|P2|Participant Flow|Chest X-ray|Participants undergo chest x-ray examination.
751842|NCT00047385|P1|Participant Flow|Low-Dose CT|Participants undergo low-dose helical CT examination.
751843|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
751844|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
751845|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
751846|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
751847|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
751848|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
751849|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
751850|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
751851|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
751852|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
751853|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
751854|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
751855|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
751856|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
751857|NCT00047385|E2|Reported Event|Chest X-ray|Participants undergo chest x-ray examination.
751858|NCT00047385|E1|Reported Event|Low-Dose CT|Participants undergo low-dose helical CT examination.
751859|NCT00047320|B1|Baseline|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
751860|NCT00047320|P1|Participant Flow|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
751861|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
751862|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
751892|NCT00046930|E1|Reported Event|Zosuquidar Induction|Induction treatment with daunorubicin, cytarabine and zosuquidar
751893|NCT00046891|B3|Baseline|Total|Total of all reporting groups
751894|NCT00046891|B2|Baseline|Placebo|Placebo: Patients will take 1 tablet BID
751863|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
751864|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
751865|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
751866|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
751867|NCT00047320|E1|Reported Event|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
751868|NCT00047008|B3|Baseline|Total|Total of all reporting groups
751869|NCT00047008|B2|Baseline|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
751870|NCT00047008|B1|Baseline|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
751871|NCT00047008|P2|Participant Flow|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
751872|NCT00047008|P1|Participant Flow|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
751873|NCT00047008|O2|Outcome|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
751874|NCT00047008|O1|Outcome|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
751875|NCT00047008|E2|Reported Event|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
751876|NCT00047008|E1|Reported Event|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
751877|NCT00046930|B3|Baseline|Total|Total of all reporting groups
751878|NCT00046930|B2|Baseline|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
751879|NCT00046930|B1|Baseline|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
751880|NCT00046930|P2|Participant Flow|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
751881|NCT00046930|P1|Participant Flow|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
751882|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
751883|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
751884|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
751885|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
751886|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
751887|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
751888|NCT00046930|E5|Reported Event|Placebo Consolidation II|Consolidation with Daunorubicin, Cytarabine and Placebo
751889|NCT00046930|E4|Reported Event|Zosuquidar Consolidation II|Consolidation with Daunorubicin, Cytarabine and Zosuquidar
751890|NCT00046930|E3|Reported Event|Consolidation I|Cytarabine 1500 mg/m2 days 1-6
751891|NCT00046930|E2|Reported Event|Placebo Induction|Induction treatment with daunorubicin, cytarabine and placebo
751904|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
751905|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
751906|NCT00046891|O2|Outcome|Placebo|Median change from baseline to different time points.
751907|NCT00046891|O1|Outcome|Ginko Bibola|Median change from baseline to different time points.
751908|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
751909|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
751910|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
751911|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
751912|NCT00046891|E2|Reported Event|Placebo|Placebo: Patients will take 1 tablet BID
751913|NCT00046891|E1|Reported Event|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
751914|NCT00046839|B3|Baseline|Total|Total of all reporting groups
751915|NCT00046839|B2|Baseline|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
751916|NCT00046839|B1|Baseline|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
751917|NCT00046839|P2|Participant Flow|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
751918|NCT00046839|P1|Participant Flow|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
751919|NCT00046839|O1|Outcome|Experimental: Phase I/II: Celecoxib 200 or 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 or 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
751920|NCT00046839|O2|Outcome|Phase I: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
751921|NCT00046839|O1|Outcome|Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
751922|NCT00046839|E2|Reported Event|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
751923|NCT00046839|E1|Reported Event|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
751924|NCT00045734|B1|Baseline|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751925|NCT00045734|P1|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751926|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751927|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
752725|NCT00025233|O2|Outcome|Grade 1 (CTCAE v 2.0)|Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
751928|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751929|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751930|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751931|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751932|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751933|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751934|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751935|NCT00045734|E1|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
751936|NCT00045708|B4|Baseline|Total|Total of all reporting groups
751937|NCT00045708|B3|Baseline|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
751938|NCT00045708|B2|Baseline|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
751939|NCT00045708|B1|Baseline|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
751940|NCT00045708|P3|Participant Flow|Group 3 - MTD Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
751941|NCT00045708|P2|Participant Flow|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
751942|NCT00045708|P1|Participant Flow|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
751943|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
751944|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD (6.8mg/m2).
751945|NCT00045708|O3|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
751946|NCT00045708|O2|Outcome|Group B [No Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
752234|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
751947|NCT00045708|O1|Outcome|Group A [Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1"
751948|NCT00045708|O3|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
751949|NCT00045708|O2|Outcome|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
751950|NCT00045708|O1|Outcome|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
751951|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
751952|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751953|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751954|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751955|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751956|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751957|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751958|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751959|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
751960|NCT00045708|O3|Outcome|Group 3 - MTD (6.8mg/m2/Day) Phase 2|"Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~ixabepilone: Given IV~MTD for no anticonvulsant arm = 6.8mg/m2/day MTD for anticonvulsant arm = 9.6mg/m2/day~Only no anticonvulsant subjects at 6.8mg/m2/day treated in Phase 2"
751961|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
752726|NCT00025233|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
751962|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
751963|NCT00045708|E3|Reported Event|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
751964|NCT00045708|E2|Reported Event|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
751965|NCT00045708|E1|Reported Event|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
751966|NCT00045630|B1|Baseline|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
751967|NCT00045630|P1|Participant Flow|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
751968|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
751969|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
751970|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
751971|NCT00045630|E1|Reported Event|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
751972|NCT00045487|B1|Baseline|OSI-774|Once-daily oral administration for 4 weeks.
751973|NCT00045487|P1|Participant Flow|OSI-774|OSI-774, continuous daily oral administration of 150mg until disease progression or 52 weeks duration. Dose adjustment, reduction by increments of 50mg will be made for dose-limiting toxicity.
751974|NCT00045487|O1|Outcome|OSI-774|Once-daily oral administration for 4 weeks.
751975|NCT00045487|E1|Reported Event|OSI-774|Once-daily oral administration for 4 weeks.
751976|NCT00045435|B1|Baseline|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751977|NCT00045435|P1|Participant Flow|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751978|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751979|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751980|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751981|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751982|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751983|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751984|NCT00045435|E1|Reported Event|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
751985|NCT00045305|B1|Baseline|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
751986|NCT00045305|P1|Participant Flow|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
751987|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
751988|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
752013|NCT00045110|P3|Participant Flow|Phase 2 - Newly Diagnosed GBM Post RT|Patients with GBM with newly diagnosed disease following Radiation (RT) started erlotinib no more than 6 weeks from the completion of RT. Temozolomide or other adjuvant chemotherapy not allowed while on erotinib
751989|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
751990|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
751991|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
751992|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
751993|NCT00045305|E1|Reported Event|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
751994|NCT00045162|B3|Baseline|Total|Total of all reporting groups
751995|NCT00045162|B2|Baseline|Cisplatin + Etoposide|
751996|NCT00045162|B1|Baseline|Cisplatin + Irinotecan|
751997|NCT00045162|P2|Participant Flow|Cisplatin + Etoposide|
751998|NCT00045162|P1|Participant Flow|Cisplatin + Irinotecan|
751999|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
752000|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
752001|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
752002|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
752003|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
752004|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
752005|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
752006|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
752007|NCT00045162|E2|Reported Event|Cisplatin + Etoposide|
752008|NCT00045162|E1|Reported Event|Cisplatin + Irinotecan|
752009|NCT00045110|B4|Baseline|Total|Total of all reporting groups
752010|NCT00045110|B3|Baseline|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
752011|NCT00045110|B2|Baseline|Phase 2 w/ Recurrent Malignant Glioma|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib at a predetermined dose (150mg/day).~Patients requiring surgery were treated 7 days prior to tumor removal PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
752012|NCT00045110|B1|Baseline|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
753222|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
752014|NCT00045110|P2|Participant Flow|Phase 2 - Recurrent Malignant Glioma|"Phase II: Once the MTD is determined, additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose.~Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
752015|NCT00045110|P1|Participant Flow|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
752016|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
752017|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
752018|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752019|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752020|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752021|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752022|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752023|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752024|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752025|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752026|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752027|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752028|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
752106|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752029|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752030|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752031|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752032|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752033|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752034|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752035|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
752036|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752037|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752038|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752039|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752040|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752041|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752042|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
752043|NCT00045110|O7|Outcome|Phase 1 Dose Escalation - 775 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752044|NCT00045110|O6|Outcome|Phase 1 Dose Escalation - 650 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752045|NCT00045110|O5|Outcome|Phase 1 Dose Escalation - 525 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752046|NCT00045110|O4|Outcome|Phase 1 Dose Escalation - 400 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752047|NCT00045110|O3|Outcome|Phase 1 Dose Escalation - 275 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752048|NCT00045110|O2|Outcome|Phase 1 Dose Escalation - 200 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity."
752049|NCT00045110|O1|Outcome|Phase 1 Dose Escalation - 150 mg|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
752050|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas and Stable Disease Post RT|"Patients with recurrent malignant gliomas not concurrently receiving EIAEDs treated with erlotinib at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752051|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752052|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
752053|NCT00045110|O1|Outcome|Phase 2 Newly Diagnosed GBM Post RT|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis"
752054|NCT00045110|O1|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs (on Enzyme-inducing Antiepileptic Drugs) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis..~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752055|NCT00045110|O1|Outcome|Phase 2 Recurrent Malignant Gliomas|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal~PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis.~erlotinib hydrochloride: given orally~laboratory biomarker analysis: correlative studies~pharmacological study: correlative studies"
752056|NCT00045110|O1|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs ( on Enzyme-inducing Antiepileptic Drugs) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
752057|NCT00045110|O1|Outcome|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs ( on Enzyme-inducing Antiepileptic Drugs ) receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.~The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~Other: pharmacological study, laboratory biomarker analysis."
752058|NCT00045110|E2|Reported Event|Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm|"Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
752059|NCT00045110|E1|Reported Event|Phase 1 Dose Escalation|"Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis."
752060|NCT00045032|B4|Baseline|Total|Total of all reporting groups
752061|NCT00045032|B3|Baseline|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752062|NCT00045032|B2|Baseline|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752063|NCT00045032|B1|Baseline|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752064|NCT00045032|P3|Participant Flow|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752065|NCT00045032|P2|Participant Flow|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752066|NCT00045032|P1|Participant Flow|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752067|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752068|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752069|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752070|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752071|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752072|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752073|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752074|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752075|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752208|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
752076|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752077|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752078|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752079|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752080|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752081|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752082|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752083|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752084|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752085|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752086|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752087|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752088|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752089|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752090|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752091|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752092|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752093|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752094|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752095|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752096|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752097|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752098|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752099|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752100|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752101|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752102|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752103|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752104|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752105|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752235|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
752107|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752108|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752109|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752110|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752111|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752112|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752113|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752114|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752115|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752116|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752117|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752118|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752119|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752120|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752121|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752122|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752123|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752124|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752125|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752126|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752127|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752128|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752129|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752130|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752131|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752132|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752133|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752134|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752135|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752136|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752137|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752138|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752139|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752140|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752141|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752142|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752143|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752144|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752145|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752146|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752147|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752148|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752149|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752150|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752151|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752152|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752153|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752209|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
753223|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
752154|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752155|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752156|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752157|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752158|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752159|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752160|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752161|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752162|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752163|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752164|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752165|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752166|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752167|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752168|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752169|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
753120|NCT00009945|P2|Participant Flow|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
752170|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752171|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752172|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752173|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752174|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752175|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752176|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752177|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752178|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752179|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752180|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752181|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752182|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752183|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752184|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752185|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752186|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752187|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752188|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
752189|NCT00045032|E3|Reported Event|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752190|NCT00045032|E2|Reported Event|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
752191|NCT00045032|E1|Reported Event|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm.
752192|NCT00042991|B8|Baseline|Total|Total of all reporting groups
752193|NCT00042991|B7|Baseline|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752194|NCT00042991|B6|Baseline|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752195|NCT00042991|B5|Baseline|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752196|NCT00042991|B4|Baseline|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752197|NCT00042991|B3|Baseline|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752198|NCT00042991|B2|Baseline|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752199|NCT00042991|B1|Baseline|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752200|NCT00042991|P7|Participant Flow|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752201|NCT00042991|P6|Participant Flow|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752202|NCT00042991|P5|Participant Flow|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752203|NCT00042991|P4|Participant Flow|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752204|NCT00042991|P3|Participant Flow|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752205|NCT00042991|P2|Participant Flow|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752206|NCT00042991|P1|Participant Flow|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
752207|NCT00042991|O1|Outcome|Stratum IB and Stratum II|Activation and mutations of EGFR have been associated with many cancers. In this secondary objective, we identify how many patients have activated EGFR and this requires a tumor sample from patients, which is only available from supratentorial malignant glioma patients treated on Stratum IB and Stratum II.
753121|NCT00009945|P1|Participant Flow|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
752210|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
752211|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
752212|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
752213|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
752214|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
752215|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
752216|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
752217|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
752218|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
752219|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
752220|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
752221|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
752222|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
752223|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
752224|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
752225|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
752226|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
752227|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
752228|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
752229|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
752230|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
752231|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
752232|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
752233|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
753122|NCT00009945|O2|Outcome|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
752236|NCT00042991|O3|Outcome|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 375 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
752237|NCT00042991|O2|Outcome|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 250 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
752238|NCT00042991|O1|Outcome|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 100 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
752239|NCT00042991|E7|Reported Event|Stratum II at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2 who are receiving EIACD
752240|NCT00042991|E6|Reported Event|Stratum IB at Dose 375 mg/m^2|Patients with STMG treated at 375 mg/m2
752241|NCT00042991|E5|Reported Event|Stratum IB at Dose 250 mg/m^2|Patients with STMG treated at 250 mg/m2
752242|NCT00042991|E4|Reported Event|Stratum IB at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2
752243|NCT00042991|E3|Reported Event|Stratum IA at Dose 375 mg/m^2|Brain Stem Glioma patients treated at 375 mg/m2
752244|NCT00042991|E2|Reported Event|Stratum IA at Dose 250 mg/m^2|Brain Stem Glioma patients treated at 250 mg/m2
752245|NCT00042991|E1|Reported Event|Stratum IA at Dose 100 mg/m^2|Brain Stem Glioma patients treated at 100 mg/m2
752246|NCT00042939|B3|Baseline|Total|Total of all reporting groups
752247|NCT00042939|B2|Baseline|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
752248|NCT00042939|B1|Baseline|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752249|NCT00042939|P2|Participant Flow|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
752250|NCT00042939|P1|Participant Flow|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752251|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
752252|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752253|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
753123|NCT00009945|O1|Outcome|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
752254|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752255|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
752256|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752257|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
752258|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752259|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
752260|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752261|NCT00042939|E2|Reported Event|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
752262|NCT00042939|E1|Reported Event|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
752263|NCT00041132|B1|Baseline|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
752727|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752264|NCT00041132|P1|Participant Flow|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
752265|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
752266|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
752267|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
752268|NCT00041132|E1|Reported Event|Hyper-CVAD + MTX/Ara-C + Rituximab|
752269|NCT00041119|B5|Baseline|Total|Total of all reporting groups
752270|NCT00041119|B4|Baseline|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
752271|NCT00041119|B3|Baseline|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752272|NCT00041119|B2|Baseline|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
752273|NCT00041119|B1|Baseline|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752274|NCT00041119|P4|Participant Flow|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
752275|NCT00041119|P3|Participant Flow|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752276|NCT00041119|P2|Participant Flow|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
752277|NCT00041119|P1|Participant Flow|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752278|NCT00041119|O2|Outcome|4 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 4 cycles or Paclitaxel for 4 cycles
752279|NCT00041119|O1|Outcome|6 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 6 cycles or Paclitaxel for 6 cycles
752280|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
752281|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
752282|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
752283|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
752284|NCT00041119|O2|Outcome|4 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 4 cycles or Paclitaxel for 4 cycles
752285|NCT00041119|O1|Outcome|6 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 6 cycles or Paclitaxel for 6 cycles
752286|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
752287|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
752728|NCT00025233|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752288|NCT00041119|O2|Outcome|Arm VI (Arm III and Arm IV) Combined|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752289|NCT00041119|O1|Outcome|Arm V (Arm I and Arm II Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
752290|NCT00041119|O2|Outcome|6 Cycles (Arm II and Arm IV Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
752291|NCT00041119|O1|Outcome|4 Cycles (Arm I and Arm III Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752292|NCT00041119|E4|Reported Event|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
752293|NCT00041119|E3|Reported Event|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752294|NCT00041119|E2|Reported Event|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
752295|NCT00041119|E1|Reported Event|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
752296|NCT00041080|B3|Baseline|Total|Total of all reporting groups
752297|NCT00041080|B2|Baseline|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
752298|NCT00041080|B1|Baseline|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
752299|NCT00041080|P2|Participant Flow|Grp - 2|Tamoxifen 20mg orally twice daily for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
752300|NCT00041080|P1|Participant Flow|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
752301|NCT00041080|O2|Outcome|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
752302|NCT00041080|O1|Outcome|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
752303|NCT00041080|E2|Reported Event|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
752304|NCT00041080|E1|Reported Event|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
752305|NCT00041067|B1|Baseline|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
752306|NCT00041067|P1|Participant Flow|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
752307|NCT00041067|O1|Outcome|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
752308|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
752309|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
752310|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
752311|NCT00041067|E1|Reported Event|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
752312|NCT00040937|B1|Baseline|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
752313|NCT00040937|P1|Participant Flow|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
752314|NCT00040937|O1|Outcome|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
752315|NCT00040937|O1|Outcome|Induction/PBSC Mobilization|
752316|NCT00040937|E3|Reported Event|Prednisone + Thalidomide|
752317|NCT00040937|E2|Reported Event|Autologous PBSCT|
752318|NCT00040937|E1|Reported Event|Induction/PBSC Mobilization|
752319|NCT00040846|B7|Baseline|Total|Total of all reporting groups
752565|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
752320|NCT00040846|B6|Baseline|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752321|NCT00040846|B5|Baseline|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752322|NCT00040846|B4|Baseline|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752323|NCT00040846|B3|Baseline|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752324|NCT00040846|B2|Baseline|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752325|NCT00040846|B1|Baseline|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752326|NCT00040846|P6|Participant Flow|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752327|NCT00040846|P5|Participant Flow|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752328|NCT00040846|P4|Participant Flow|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752414|NCT00036738|B1|Baseline|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
752329|NCT00040846|P3|Participant Flow|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752330|NCT00040846|P2|Participant Flow|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752331|NCT00040846|P1|Participant Flow|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752332|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752333|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752334|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752335|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752336|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752337|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752415|NCT00036738|P1|Participant Flow|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
753224|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
752338|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752339|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752340|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752341|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752342|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752343|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752344|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752345|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752346|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752416|NCT00036738|O1|Outcome|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
752347|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752348|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752349|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752350|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752351|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752352|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752353|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752354|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752355|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752417|NCT00036738|O1|Outcome|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
753225|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
752356|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752357|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752358|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752359|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752360|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752361|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752362|NCT00040846|E6|Reported Event|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752363|NCT00040846|E5|Reported Event|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752364|NCT00040846|E4|Reported Event|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752418|NCT00036738|O1|Outcome|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
752365|NCT00040846|E3|Reported Event|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752366|NCT00040846|E2|Reported Event|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
752367|NCT00040846|E1|Reported Event|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
752368|NCT00040742|B5|Baseline|Total|Total of all reporting groups
752369|NCT00040742|B4|Baseline|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
752370|NCT00040742|B3|Baseline|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752371|NCT00040742|B2|Baseline|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752372|NCT00040742|B1|Baseline|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
752373|NCT00040742|P4|Participant Flow|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
752374|NCT00040742|P3|Participant Flow|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752375|NCT00040742|P2|Participant Flow|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752376|NCT00040742|P1|Participant Flow|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
752377|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
752378|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752379|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752380|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
752381|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
752382|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752383|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752384|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
752385|NCT00040742|E4|Reported Event|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
752386|NCT00040742|E3|Reported Event|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752387|NCT00040742|E2|Reported Event|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
752388|NCT00040742|E1|Reported Event|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
752389|NCT00039377|B1|Baseline|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
752390|NCT00039377|P4|Participant Flow|Patients Who Did Not Undergo Transplant for Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752482|NCT00033371|E2|Reported Event|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
752391|NCT00039377|P3|Participant Flow|Patients Without HLA-matched Sibling Donors in Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752392|NCT00039377|P2|Participant Flow|Patients With HLA-matched Sibling Donor in Course 5|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752393|NCT00039377|P1|Participant Flow|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
752394|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752395|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752396|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752397|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752398|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
752399|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
752400|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
752401|NCT00039377|E3|Reported Event|Patients Who Did Not Undergo Transplant|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752402|NCT00039377|E2|Reported Event|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752419|NCT00036738|E1|Reported Event|Treatment (Allogeneic Nonmyeloablative HSCT)|"See Detailed Description~Cyclosporine: Given IV or PO~Dasatinib: Given PO~Fludarabine Phosphate: Given IV~Imatinib Mesylate: Given PO~Mycophenolate Mofetil: Given PO~Nilotinib: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation~Therapeutic Allogeneic Lymphocytes: Given IV~Total-Body Irradiation: Undergo TBI"
752403|NCT00039377|E1|Reported Event|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
752404|NCT00039195|B1|Baseline|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
752405|NCT00039195|P1|Participant Flow|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
752406|NCT00039195|O1|Outcome|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
752407|NCT00039195|E1|Reported Event|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
752408|NCT00039130|B1|Baseline|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
752409|NCT00039130|P1|Participant Flow|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
752410|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
752411|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
752412|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
752413|NCT00039130|E1|Reported Event|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
752420|NCT00033657|B3|Baseline|Total|Total of all reporting groups
752421|NCT00033657|B2|Baseline|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
752422|NCT00033657|B1|Baseline|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
752423|NCT00033657|P2|Participant Flow|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
752424|NCT00033657|P1|Participant Flow|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
752425|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
752426|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
752427|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
752428|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
752429|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
752430|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
752431|NCT00033657|E4|Reported Event|Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B)|
752432|NCT00033657|E3|Reported Event|Adjuvant_Cisplatin / Irinotecan / RT ( Arm A)|Adjuvant chemotherapy toxicities in treated patients
752433|NCT00033657|E2|Reported Event|Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
752434|NCT00033657|E1|Reported Event|Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
752435|NCT00033631|B3|Baseline|Total|Total of all reporting groups
752436|NCT00033631|B2|Baseline|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
753124|NCT00009945|O2|Outcome|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
752437|NCT00033631|B1|Baseline|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752438|NCT00033631|P2|Participant Flow|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752439|NCT00033631|P1|Participant Flow|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752440|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752441|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752442|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752443|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752444|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752445|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752446|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752447|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752448|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752449|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752450|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752451|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752452|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752453|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752481|NCT00033371|O1|Outcome|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
752483|NCT00033371|E1|Reported Event|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
752454|NCT00033631|E2|Reported Event|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
752455|NCT00033631|E1|Reported Event|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
752456|NCT00033540|B1|Baseline|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752457|NCT00033540|P1|Participant Flow|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752458|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752459|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752460|NCT00033540|O1|Outcome|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752461|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752462|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752463|NCT00033540|E1|Reported Event|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
752464|NCT00033514|B3|Baseline|Total|Total of all reporting groups
752465|NCT00033514|B2|Baseline|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
752466|NCT00033514|B1|Baseline|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
752467|NCT00033514|P2|Participant Flow|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
752468|NCT00033514|P1|Participant Flow|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
752469|NCT00033514|O1|Outcome|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
752470|NCT00033514|O1|Outcome|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride:150 mg daily."
752471|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
752472|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 150 mg daily."
752473|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 150 mg daily."
752474|NCT00033514|E1|Reported Event|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
752475|NCT00033371|B3|Baseline|Total|Total of all reporting groups
752476|NCT00033371|B2|Baseline|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
752477|NCT00033371|B1|Baseline|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
752478|NCT00033371|P2|Participant Flow|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
752479|NCT00033371|P1|Participant Flow|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
752480|NCT00033371|O2|Outcome|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
752485|NCT00033293|B2|Baseline|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
752486|NCT00033293|B1|Baseline|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
752487|NCT00033293|P2|Participant Flow|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
752488|NCT00033293|P1|Participant Flow|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
752489|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
752490|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
752491|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
752492|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
752493|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
752494|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
752495|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
752496|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
752497|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
752498|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
752499|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
752500|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
752501|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
752502|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
752557|NCT00027846|E1|Reported Event|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
752872|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752503|NCT00033293|E2|Reported Event|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
752504|NCT00033293|E1|Reported Event|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
752505|NCT00031694|B1|Baseline|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
752506|NCT00031694|P1|Participant Flow|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
752507|NCT00031694|O1|Outcome|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
752508|NCT00031694|E1|Reported Event|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
752509|NCT00030901|B3|Baseline|Total|Total of all reporting groups
752510|NCT00030901|B2|Baseline|Placebo|Patients receive oral placebo once daily for 3 years
752511|NCT00030901|B1|Baseline|Selenium|Patients receive oral selenium once daily for 3 years
752512|NCT00030901|P3|Participant Flow|Placebo|Patients receive oral placebo once daily for 3 years
752513|NCT00030901|P2|Participant Flow|Selenium|Patients receive oral selenium once daily for 3 years
752514|NCT00030901|P1|Participant Flow|All Patients|
752515|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
752516|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
752517|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
752518|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
752519|NCT00030901|E2|Reported Event|Placebo|Patients receive oral placebo once daily for 3 years
752520|NCT00030901|E1|Reported Event|Selenium|Patients receive oral selenium once daily for 3 years
752521|NCT00030823|B1|Baseline|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
752522|NCT00030823|P1|Participant Flow|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
752523|NCT00030823|O1|Outcome|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
752524|NCT00030823|E1|Reported Event|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
752525|NCT00028769|B1|Baseline|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
752526|NCT00028769|P1|Participant Flow|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
752527|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
752558|NCT00027560|B1|Baseline|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
752528|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
752529|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
752530|NCT00028769|E1|Reported Event|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
752531|NCT00028002|B1|Baseline|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
752532|NCT00028002|P1|Participant Flow|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
752533|NCT00028002|O1|Outcome|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
752534|NCT00028002|E1|Reported Event|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
752535|NCT00027846|B4|Baseline|Total|Total of all reporting groups
752536|NCT00027846|B3|Baseline|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
752537|NCT00027846|B2|Baseline|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
752538|NCT00027846|B1|Baseline|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
752539|NCT00027846|P3|Participant Flow|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
752540|NCT00027846|P2|Participant Flow|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
752541|NCT00027846|P1|Participant Flow|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
752559|NCT00027560|P1|Participant Flow|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
752560|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
752561|NCT00027560|O1|Outcome|Matched Related Patients|
752562|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
752563|NCT00027560|O1|Outcome|Matched Related Patients|
752542|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
752543|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
752544|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
752545|NCT00027846|O2|Outcome|Anaplastic Ependymoma|Anaplastic ependymoma:tumor pathology by central review.
752546|NCT00027846|O1|Outcome|Differentiated Ependymoma|Differentiated ependymoma:tumor pathology by central review.
752547|NCT00027846|O2|Outcome|Anaplastic Ependymoma|Anaplastic ependymoma:tumor pathology by central review.
752548|NCT00027846|O1|Outcome|Differentiated Ependymoma|Differentiated ependymoma:tumor pathology by central review.
752549|NCT00027846|O1|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
752550|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
752551|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
752552|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
752553|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
752554|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
752555|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
752556|NCT00027846|E2|Reported Event|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
752564|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
752566|NCT00027560|E1|Reported Event|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
752567|NCT00026494|B5|Baseline|Total|Total of all reporting groups
752568|NCT00026494|B4|Baseline|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752569|NCT00026494|B3|Baseline|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752570|NCT00026494|B2|Baseline|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752571|NCT00026494|B1|Baseline|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752572|NCT00026494|P4|Participant Flow|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752573|NCT00026494|P3|Participant Flow|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752574|NCT00026494|P2|Participant Flow|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752575|NCT00026494|P1|Participant Flow|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752576|NCT00026494|O4|Outcome|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752577|NCT00026494|O3|Outcome|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752578|NCT00026494|O2|Outcome|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752579|NCT00026494|O1|Outcome|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752580|NCT00026494|E4|Reported Event|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752581|NCT00026494|E3|Reported Event|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752582|NCT00026494|E2|Reported Event|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752583|NCT00026494|E1|Reported Event|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
752584|NCT00026312|B3|Baseline|Total|Total of all reporting groups
752585|NCT00026312|B2|Baseline|Regimen B|Regimen B - RA + Immunotherapy
752586|NCT00026312|B1|Baseline|Regimen A|Randomized to Regimen A - RA Only
752587|NCT00026312|P2|Participant Flow|Regimen B|Regimen B – RA + Immunotherapy
752588|NCT00026312|P1|Participant Flow|Regimen A|Randomized to Regimen A – RA Only
752589|NCT00026312|O1|Outcome|Regimen B|Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
752590|NCT00026312|O2|Outcome|Regimen B|Randomized to Regimen B - RA + Immunotherapy
752591|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
752592|NCT00026312|O1|Outcome|Regimen B|Regimen B- RA + Immunotherapy
752593|NCT00026312|O2|Outcome|Regimen B|Patients that received RA + Immunotherapy before halting of randomization
752594|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
752595|NCT00026312|O1|Outcome|Regimen B|Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
752596|NCT00026312|O2|Outcome|Regimen B|Regimen B - RA + Immunotherapy
752597|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
752598|NCT00026312|O2|Outcome|Regimen B|Randomized to Regimen B - RA + Immunotherapy
752599|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
752600|NCT00026312|E2|Reported Event|Regimen B|Regimen B – RA + Immunotherapy
752601|NCT00026312|E1|Reported Event|Regimen A|Randomized to Regimen A - RA Only
752602|NCT00026221|B4|Baseline|Total|Total of all reporting groups
752603|NCT00026221|B3|Baseline|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752604|NCT00026221|B2|Baseline|Arm II (Monoclonal Antibody)|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
752605|NCT00026221|B1|Baseline|Arm I (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752606|NCT00026221|P3|Participant Flow|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752607|NCT00026221|P2|Participant Flow|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
752608|NCT00026221|P1|Participant Flow|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752609|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752610|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
752611|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752612|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752613|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
752873|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752614|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752615|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752616|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
752617|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752618|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752619|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
752620|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752621|NCT00026221|E3|Reported Event|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752622|NCT00026221|E2|Reported Event|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
752623|NCT00026221|E1|Reported Event|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
752624|NCT00026208|B3|Baseline|Total|Total of all reporting groups
752625|NCT00026208|B2|Baseline|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752626|NCT00026208|B1|Baseline|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752627|NCT00026208|P2|Participant Flow|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752628|NCT00026208|P1|Participant Flow|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752629|NCT00026208|O2|Outcome|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752630|NCT00026208|O1|Outcome|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752631|NCT00026208|O2|Outcome|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752643|NCT00025662|B1|Baseline|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
752751|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
752632|NCT00026208|O1|Outcome|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752633|NCT00026208|O2|Outcome|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752634|NCT00026208|O1|Outcome|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752635|NCT00026208|O2|Outcome|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752636|NCT00026208|O1|Outcome|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752637|NCT00026208|O2|Outcome|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752638|NCT00026208|O1|Outcome|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752639|NCT00026208|O2|Outcome|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752640|NCT00026208|O1|Outcome|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752641|NCT00026208|E2|Reported Event|Stanford V-C Only|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)"
752642|NCT00026208|E1|Reported Event|Stanford V-C + Low-dose Radiotherapy|"Stanford V-C = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.~Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8~Cyclophosphamide: 650 mg/m², on week 1 and 5~Doxorubicin: 25 mg/m², on week 1, 3, 5, 7~Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy~Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8~Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)~Low-dose radiotherapy (RT) = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen."
752705|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
752644|NCT00025662|P1|Participant Flow|"RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants"|"Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults"
752645|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
752646|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
752647|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
752648|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
752649|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
752650|NCT00025662|E1|Reported Event|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
752651|NCT00025506|B1|Baseline|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752652|NCT00025506|P1|Participant Flow|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752653|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752654|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752655|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752656|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752657|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752658|NCT00025506|O5|Outcome|Grade 4|Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
752659|NCT00025506|O4|Outcome|Grade 3|Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)
752660|NCT00025506|O3|Outcome|Grade 2|Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)
752661|NCT00025506|O2|Outcome|Grade 1|Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)
752662|NCT00025506|O1|Outcome|Grade 0|Number of patients who did not experience the adverse event.
752663|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752664|NCT00025506|E1|Reported Event|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
752665|NCT00025259|B8|Baseline|Total|Total of all reporting groups
752666|NCT00025259|B7|Baseline|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752706|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
752729|NCT00025155|B1|Baseline|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
752874|NCT00022659|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752667|NCT00025259|B6|Baseline|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
752668|NCT00025259|B5|Baseline|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752669|NCT00025259|B4|Baseline|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752670|NCT00025259|B3|Baseline|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752671|NCT00025259|B2|Baseline|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752672|NCT00025259|B1|Baseline|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752673|NCT00025259|P7|Participant Flow|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752674|NCT00025259|P6|Participant Flow|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
752722|NCT00025233|O5|Outcome|Grade 4 (CTCAE v 2.0)|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
752723|NCT00025233|O4|Outcome|Grade 3 (CTCAE v 2.0)|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
752724|NCT00025233|O3|Outcome|Grade 2 (CTCAE v 2.0)|Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
752675|NCT00025259|P5|Participant Flow|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752676|NCT00025259|P4|Participant Flow|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752677|NCT00025259|P3|Participant Flow|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752678|NCT00025259|P2|Participant Flow|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752679|NCT00025259|P1|Participant Flow|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752680|NCT00025259|O6|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
752681|NCT00025259|O5|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
752682|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
752683|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
752684|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
752685|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
752686|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
752687|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
752688|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
752689|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
752690|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
752691|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
752692|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
752693|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
752694|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
752695|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
752696|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
752697|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
752698|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
752699|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
752700|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
752701|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
752702|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
752703|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
752704|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT (Reduced Therapy Arm)
752707|NCT00025259|E7|Reported Event|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752708|NCT00025259|E6|Reported Event|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
752709|NCT00025259|E5|Reported Event|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752710|NCT00025259|E4|Reported Event|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752711|NCT00025259|E3|Reported Event|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752712|NCT00025259|E2|Reported Event|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752713|NCT00025259|E1|Reported Event|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
752714|NCT00025233|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752715|NCT00025233|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752716|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752717|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752718|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752719|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752720|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752721|NCT00025233|O6|Outcome|Grade 5 (CTCAE v 2.0)|Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
752730|NCT00025155|P1|Participant Flow|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
752731|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
752732|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
752733|NCT00025155|O5|Outcome|Grade 4|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
752734|NCT00025155|O4|Outcome|Grade 3|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
752735|NCT00025155|O3|Outcome|Grade 2|Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
752736|NCT00025155|O2|Outcome|Grade 1|Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
752737|NCT00025155|O1|Outcome|Grade 0|Number of patients who did not experience the specified AE.
752738|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
752739|NCT00025155|E1|Reported Event|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
752740|NCT00024258|B1|Baseline|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
752741|NCT00024258|P1|Participant Flow|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
752742|NCT00024258|O1|Outcome|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
752743|NCT00024258|E1|Reported Event|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
752744|NCT00024167|B4|Baseline|Total|Total of all reporting groups
752745|NCT00024167|B3|Baseline|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
752746|NCT00024167|B2|Baseline|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
752747|NCT00024167|B1|Baseline|Induction Treatment|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
752748|NCT00024167|P2|Participant Flow|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
752749|NCT00024167|P1|Participant Flow|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
752750|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
752875|NCT00022633|B3|Baseline|Total|Total of all reporting groups
752752|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
752753|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
752754|NCT00024167|E3|Reported Event|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
752755|NCT00024167|E2|Reported Event|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
752756|NCT00024167|E1|Reported Event|Induction Treatment|Induction treatment option 1 or induction treatment option 2.
752757|NCT00024102|B3|Baseline|Total|Total of all reporting groups
752758|NCT00024102|B2|Baseline|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
752759|NCT00024102|B1|Baseline|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
752760|NCT00024102|P2|Participant Flow|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
752761|NCT00024102|P1|Participant Flow|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles~OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
752762|NCT00024102|O3|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
752763|NCT00024102|O2|Outcome|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
752764|NCT00024102|O1|Outcome|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
752765|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
752766|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
752767|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
752768|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
752769|NCT00024102|E3|Reported Event|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
752770|NCT00024102|E2|Reported Event|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
752771|NCT00024102|E1|Reported Event|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
752772|NCT00023764|B1|Baseline|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
752773|NCT00023764|P1|Participant Flow|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
752774|NCT00023764|O2|Outcome|PS-341 (Bortezomib)-Refractory Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
752775|NCT00023764|O1|Outcome|PS-341 (Bortezomib)-Relapsed Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
752776|NCT00023764|E1|Reported Event|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
752777|NCT00023712|B3|Baseline|Total|Total of all reporting groups
752778|NCT00023712|B2|Baseline|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752779|NCT00023712|B1|Baseline|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752840|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752780|NCT00023712|P2|Participant Flow|Cohort 2 - Bortezomib (1.3 mg/m2)|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752781|NCT00023712|P1|Participant Flow|Cohort 1 - Bortezomib (1.5 mg/m2)|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752782|NCT00023712|O2|Outcome|Cohort 2 - Bortezomib (1.3 mg/m2)|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752783|NCT00023712|O1|Outcome|Cohort 1 - Bortezomib 1.5 (mg/m2)|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752784|NCT00023712|O2|Outcome|Cohort 2 - Bortezomib (1.3 mg/m2)|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752785|NCT00023712|O1|Outcome|Cohort 1 - Bortezomib 1.5 (mg/m2)|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752786|NCT00023712|O2|Outcome|Cohort 2 - Bortezomib (1.3 mg/m2)|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752787|NCT00023712|O1|Outcome|Cohort 1 - Bortezomib 1.5 (mg/m2)|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752788|NCT00023712|O10|Outcome|Grade 4 AEs (CTCAE v 2.0) Cohort 2- Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 2.
752789|NCT00023712|O9|Outcome|Grade 3 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 2.
752790|NCT00023712|O8|Outcome|Grade 2 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in cohort 2
752791|NCT00023712|O7|Outcome|Grade 1 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 2.
752792|NCT00023712|O6|Outcome|Grade 0 AEs Cohort 2 - Bortezomib (1.3 mg/m2)|Number of patients who did not experience the specified AE in cohort 2
752793|NCT00023712|O5|Outcome|Grade 4 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 1.
752794|NCT00023712|O4|Outcome|Grade 3 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 1
752795|NCT00023712|O3|Outcome|Grade 2 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in Cohort 1.
752796|NCT00023712|O2|Outcome|Grade 1 AEs (CTCAE v.2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 1
752797|NCT00023712|O1|Outcome|Grade 0 AEs Cohort 1 - Bortezomib 1.5 (mg/m2)|Number of patients who did not experience the specified AE in cohort 1.
752798|NCT00023712|O2|Outcome|Cohort 2 - Bortezomib (1.3 mg/m2)|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752799|NCT00023712|O1|Outcome|Cohort 1 - Bortezomib 1.5 (mg/m2)|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752800|NCT00023712|E2|Reported Event|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752801|NCT00023712|E1|Reported Event|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
752802|NCT00022698|B3|Baseline|Total|Total of all reporting groups
752841|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752876|NCT00022633|B2|Baseline|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752803|NCT00022698|B2|Baseline|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752804|NCT00022698|B1|Baseline|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752805|NCT00022698|P2|Participant Flow|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752806|NCT00022698|P1|Participant Flow|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752807|NCT00022698|O3|Outcome|Total Participants (Cohort 1 + Cohort 2)|Total of all reporting groups.
752808|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752809|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752810|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752811|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752812|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752842|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752877|NCT00022633|B1|Baseline|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752813|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752814|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752815|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752816|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752817|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752818|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752819|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752820|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752821|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752822|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752823|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752824|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752825|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen:(Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752826|NCT00022698|E2|Reported Event|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752827|NCT00022698|E1|Reported Event|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
752828|NCT00022672|B3|Baseline|Total|Total of all reporting groups
752829|NCT00022672|B2|Baseline|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752830|NCT00022672|B1|Baseline|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752831|NCT00022672|P2|Participant Flow|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752832|NCT00022672|P1|Participant Flow|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752833|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752834|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752835|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752836|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752837|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752838|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752839|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752871|NCT00022659|O1|Outcome|Grade 1 (CTCAE v 2.0)|Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
752843|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752844|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752845|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752846|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752847|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752848|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752849|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752850|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752851|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752852|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752853|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752854|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752855|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752856|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752857|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752858|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752859|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752860|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752861|NCT00022672|E3|Reported Event|Anastrozole (After Start of Trastuzumab)|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
752862|NCT00022672|E2|Reported Event|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase.
752863|NCT00022672|E1|Reported Event|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
752864|NCT00022659|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752865|NCT00022659|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752866|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752867|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
752868|NCT00022659|O4|Outcome|Grade 4 (CTCAE v 2.0)|Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
752869|NCT00022659|O3|Outcome|Grade 3 (CTCAE v 2.0)|Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
752870|NCT00022659|O2|Outcome|Grade 2 (CTCAE v 2.0)|Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
752878|NCT00022633|P2|Participant Flow|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752879|NCT00022633|P1|Participant Flow|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752880|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752881|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752882|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752883|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752884|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752885|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752886|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752887|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752888|NCT00022633|E1|Reported Event|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
752889|NCT00022516|B3|Baseline|Total|Total of all reporting groups
752890|NCT00022516|B2|Baseline|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
752891|NCT00022516|B1|Baseline|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
752892|NCT00022516|P2|Participant Flow|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
752893|NCT00022516|P1|Participant Flow|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
752894|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
752895|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
752896|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
752897|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
752898|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
752899|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
752900|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
752901|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
752902|NCT00022516|E2|Reported Event|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
752903|NCT00022516|E1|Reported Event|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
752904|NCT00022490|B1|Baseline|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
752905|NCT00022490|P1|Participant Flow|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
752906|NCT00022490|O1|Outcome|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
753226|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
752907|NCT00022490|E1|Reported Event|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
752908|NCT00021255|B4|Baseline|Total|Total of all reporting groups
752909|NCT00021255|B3|Baseline|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752910|NCT00021255|B2|Baseline|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752911|NCT00021255|B1|Baseline|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
752912|NCT00021255|P3|Participant Flow|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752913|NCT00021255|P2|Participant Flow|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752914|NCT00021255|P1|Participant Flow|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
752915|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752916|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752917|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
752918|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752919|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752920|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
752921|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
753125|NCT00009945|O1|Outcome|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
752922|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752923|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
752924|NCT00021255|E3|Reported Event|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752925|NCT00021255|E2|Reported Event|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
752926|NCT00021255|E1|Reported Event|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
752927|NCT00021229|B4|Baseline|Total|Total of all reporting groups
752928|NCT00021229|B3|Baseline|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752929|NCT00021229|B2|Baseline|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752930|NCT00021229|B1|Baseline|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752931|NCT00021229|P3|Participant Flow|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752932|NCT00021229|P2|Participant Flow|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752933|NCT00021229|P1|Participant Flow|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752934|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752935|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752936|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752937|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752938|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752939|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752940|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752941|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752942|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752992|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752943|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752944|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752945|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752946|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752947|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752948|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752949|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752950|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752976|NCT00019682|P1|Participant Flow|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
753027|NCT00014495|B5|Baseline|Total|Total of all reporting groups
752951|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752952|NCT00021229|O2|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752953|NCT00021229|O1|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752954|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752955|NCT00021229|E3|Reported Event|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
752956|NCT00021229|E2|Reported Event|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
752957|NCT00021229|E1|Reported Event|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
752958|NCT00020722|B1|Baseline|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 mins. prior to and then 3, 6, and 9 hrs after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
752977|NCT00019682|O2|Outcome|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752959|NCT00020722|P1|Participant Flow|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
752960|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 mg/m2.~Carboplatin at a dose of"
752961|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
752962|NCT00020722|E1|Reported Event|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
752963|NCT00019747|B3|Baseline|Total|Total of all reporting groups
752964|NCT00019747|B2|Baseline|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
752965|NCT00019747|B1|Baseline|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
752966|NCT00019747|P2|Participant Flow|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
752967|NCT00019747|P1|Participant Flow|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
752968|NCT00019747|O2|Outcome|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
752969|NCT00019747|O1|Outcome|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
752970|NCT00019747|E2|Reported Event|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
752971|NCT00019747|E1|Reported Event|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
752972|NCT00019682|B3|Baseline|Total|Total of all reporting groups
752973|NCT00019682|B2|Baseline|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752974|NCT00019682|B1|Baseline|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752975|NCT00019682|P2|Participant Flow|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
753126|NCT00009945|O2|Outcome|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
752978|NCT00019682|O1|Outcome|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752979|NCT00019682|O2|Outcome|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752980|NCT00019682|O1|Outcome|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752981|NCT00019682|O2|Outcome|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752982|NCT00019682|O1|Outcome|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752983|NCT00019682|O2|Outcome|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752984|NCT00019682|O1|Outcome|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752985|NCT00019682|E2|Reported Event|Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)|"Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~gp100 Antigen: Given SC~Montanide ISA 51 VG: Given SC~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752986|NCT00019682|E1|Reported Event|Arm I (Aldesleukin)|"Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.~Aldesleukin: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Laboratory Biomarker Analysis: Correlative studies"
752987|NCT00019604|B1|Baseline|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752988|NCT00019604|P1|Participant Flow|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752989|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752990|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752991|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752993|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752994|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752995|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752996|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752997|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752998|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
752999|NCT00019604|E1|Reported Event|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
753000|NCT00017563|B1|Baseline|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
753001|NCT00017563|P1|Participant Flow|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
753002|NCT00017563|O1|Outcome|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
753003|NCT00017563|E1|Reported Event|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
753004|NCT00016913|B1|Baseline|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
753005|NCT00016913|P1|Participant Flow|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
753006|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
753007|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
753008|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
753009|NCT00016913|E1|Reported Event|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.
753010|NCT00016354|B1|Baseline|Benzoylphenylurea|BPU, administered over a dose range of 5–320 mg
753011|NCT00016354|P8|Participant Flow|Benzoylphenylurea Dose Level of 150 mg|Benzoylphenylurea dose level of 150 mg; Dose level 8 (for this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.)
753012|NCT00016354|P7|Participant Flow|Benzoylphenylurea 320 mg|Benzoylphenylurea dose level of 320 mg; Dose level 7
753013|NCT00016354|P6|Participant Flow|Benzoylphenylurea 160 mg|Benzoylphenylurea dose level of 160 mg; Dose level 6
753014|NCT00016354|P5|Participant Flow|Benzoylphenylurea 80 mg|Benzoylphenylurea dose level of 80 mg; Dose level 5
753015|NCT00016354|P4|Participant Flow|Benzoylphenylurea 40 mg|Benzoylphenylurea dose level of 40 mg; Dose level 4
753016|NCT00016354|P3|Participant Flow|Benzoylphenylurea 20 mg|Benzoylphenylurea dose level of 20 mg; Dose level 3
753017|NCT00016354|P2|Participant Flow|Benzoylphenylurea 10 mg|Benzoylphenylurea dose level of 10 mg; Dose level 2
753018|NCT00016354|P1|Participant Flow|Benzoylphenylurea 5 mg|Benzoylphenylurea dose level of 5 mg; Dose level 1
753019|NCT00016354|O1|Outcome|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
753020|NCT00016354|E1|Reported Event|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
753021|NCT00015847|B1|Baseline|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
753022|NCT00015847|P1|Participant Flow|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
753023|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
753024|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
753025|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
753026|NCT00015847|E1|Reported Event|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
753028|NCT00014495|B4|Baseline|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753029|NCT00014495|B3|Baseline|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753030|NCT00014495|B2|Baseline|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753031|NCT00014495|B1|Baseline|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753032|NCT00014495|P4|Participant Flow|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753033|NCT00014495|P3|Participant Flow|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753034|NCT00014495|P2|Participant Flow|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753035|NCT00014495|P1|Participant Flow|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753036|NCT00014495|O1|Outcome|Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.~Patients are followed twice weekly for 4 weeks and then monthly for 3 months~filgrastim~cytarabine~bismuth Bi213 monoclonal antibody M195"
753048|NCT00012298|B1|Baseline|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
753037|NCT00014495|E4|Reported Event|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753038|NCT00014495|E3|Reported Event|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753039|NCT00014495|E2|Reported Event|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753040|NCT00014495|E1|Reported Event|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
753041|NCT00012298|B8|Baseline|Total|Total of all reporting groups
753042|NCT00012298|B7|Baseline|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753043|NCT00012298|B6|Baseline|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753044|NCT00012298|B5|Baseline|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753045|NCT00012298|B4|Baseline|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753046|NCT00012298|B3|Baseline|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753047|NCT00012298|B2|Baseline|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
753074|NCT00012298|E2|Reported Event|Treatment: Trial 1, Dose Level 2|0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
753049|NCT00012298|P7|Participant Flow|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753050|NCT00012298|P6|Participant Flow|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753051|NCT00012298|P5|Participant Flow|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753052|NCT00012298|P4|Participant Flow|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753053|NCT00012298|P3|Participant Flow|Treatment: Trial 2, Dose Level 3|"Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753054|NCT00012298|P2|Participant Flow|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
753055|NCT00012298|P1|Participant Flow|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
753056|NCT00012298|O1|Outcome|Treatment : Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753057|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753058|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753075|NCT00012298|E1|Reported Event|Treatment: Trial 1, Dose Level 1|0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
753076|NCT00012012|B3|Baseline|Total|Total of all reporting groups
753127|NCT00009945|O1|Outcome|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
753059|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753060|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753061|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
753062|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
753063|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753064|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
753065|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753066|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~50 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
753067|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
753068|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
753069|NCT00012298|E7|Reported Event|Treatment : Phase II (Dose Level 6)|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
753070|NCT00012298|E6|Reported Event|Treatment: Trial 3, Dose Level 6|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
753071|NCT00012298|E5|Reported Event|Treatment: Trial 3, Dose Level 5|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
753072|NCT00012298|E4|Reported Event|Treatment: Trial 2, Dose Level 4|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
753073|NCT00012298|E3|Reported Event|Treatment: Trial 2, Dose Level 3|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
753116|NCT00010257|E1|Reported Event|Thymoma|Patients with diagnosis of thymoma
753077|NCT00012012|B2|Baseline|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
753078|NCT00012012|B1|Baseline|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
753079|NCT00012012|P2|Participant Flow|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
753080|NCT00012012|P1|Participant Flow|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
753081|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin and Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
753082|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
753083|NCT00012012|E2|Reported Event|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
753084|NCT00012012|E1|Reported Event|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
753085|NCT00011986|B6|Baseline|Total|Total of all reporting groups
753086|NCT00011986|B5|Baseline|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753087|NCT00011986|B4|Baseline|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753088|NCT00011986|B3|Baseline|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
753089|NCT00011986|B2|Baseline|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
753090|NCT00011986|B1|Baseline|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
753091|NCT00011986|P5|Participant Flow|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753092|NCT00011986|P4|Participant Flow|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753093|NCT00011986|P3|Participant Flow|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
753094|NCT00011986|P2|Participant Flow|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
753095|NCT00011986|P1|Participant Flow|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
753096|NCT00011986|O5|Outcome|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753097|NCT00011986|O4|Outcome|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753098|NCT00011986|O3|Outcome|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
753099|NCT00011986|O2|Outcome|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
753100|NCT00011986|O1|Outcome|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
753101|NCT00011986|E5|Reported Event|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753102|NCT00011986|E4|Reported Event|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
753103|NCT00011986|E3|Reported Event|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
753104|NCT00011986|E2|Reported Event|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
753105|NCT00011986|E1|Reported Event|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
753106|NCT00010257|B3|Baseline|Total|Total of all reporting groups
753107|NCT00010257|B2|Baseline|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
753108|NCT00010257|B1|Baseline|Thymoma|Patients with diagnosis of thymoma
753109|NCT00010257|P2|Participant Flow|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
753110|NCT00010257|P1|Participant Flow|Thymoma|Patients with diagnosis of thymoma
753111|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
753112|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
753113|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
753114|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
753115|NCT00010257|E2|Reported Event|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
753128|NCT00009945|O2|Outcome|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
753129|NCT00009945|O1|Outcome|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
753130|NCT00009945|O2|Outcome|Arm 2: Placebo|"Patient receives 2 tablets once daily for 3 years.~placebo: 2 pills PO daily"
753131|NCT00009945|O1|Outcome|Arm 1: Clodronate|"Patient receives 2 tablets once daily for 3 years.~clodronate: 1600 mg PO daily"
753132|NCT00009945|E2|Reported Event|Placebo|Placebo
753133|NCT00009945|E1|Reported Event|Clodronate|Clodronate
753134|NCT00008385|B3|Baseline|Total|Total of all reporting groups
753135|NCT00008385|B2|Baseline|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
753136|NCT00008385|B1|Baseline|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
753137|NCT00008385|P2|Participant Flow|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
753138|NCT00008385|P1|Participant Flow|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
753139|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
753140|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
753141|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
753142|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
753143|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
753144|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
753145|NCT00008385|E2|Reported Event|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
753146|NCT00008385|E1|Reported Event|Arm I (Placebo)|Participants receive an oral yeast placebo as in arm II. placebo: Given orally
753147|NCT00008138|B1|Baseline|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
753148|NCT00008138|P1|Participant Flow|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
753149|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
753150|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
753151|NCT00008138|E2|Reported Event|Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)|post-surgery chemotherapy with IV and IP carboplatin and paclitaxel
753152|NCT00008138|E1|Reported Event|Neoadjuvant Paclitaxel (IV) + Carboplatin (V)|Pre-surgery IV chemotherapy with paclitaxel and carboplatin
753153|NCT00006916|B1|Baseline|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
753154|NCT00006916|P1|Participant Flow|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
753155|NCT00006916|O1|Outcome|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
753156|NCT00006916|E1|Reported Event|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
753157|NCT00006903|B3|Baseline|Total|Total of all reporting groups
753158|NCT00006903|B2|Baseline|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753217|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
753218|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
753159|NCT00006903|B1|Baseline|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753160|NCT00006903|P3|Participant Flow|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753161|NCT00006903|P2|Participant Flow|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753162|NCT00006903|P1|Participant Flow|Ineligible|Not eligible
753163|NCT00006903|O3|Outcome|Grade 5|Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
753164|NCT00006903|O2|Outcome|Grade 4 (CTCAE v 3.0)|Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
753165|NCT00006903|O1|Outcome|Grade 3 (CTCAE v 3.0)|Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
753166|NCT00006903|O2|Outcome|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753167|NCT00006903|O1|Outcome|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753168|NCT00006903|O2|Outcome|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753169|NCT00006903|O1|Outcome|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
753170|NCT00006903|E1|Reported Event|Faslodex|"Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy.~Includes both Estrogen Receptor Positive and Estrogen Receptor Negative participants."
753171|NCT00006721|B4|Baseline|Total|Total of all reporting groups
753172|NCT00006721|B3|Baseline|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
753173|NCT00006721|B2|Baseline|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753174|NCT00006721|B1|Baseline|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753175|NCT00006721|P3|Participant Flow|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753176|NCT00006721|P2|Participant Flow|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753177|NCT00006721|P1|Participant Flow|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
753178|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753179|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753180|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753181|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753182|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753219|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
753220|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
753221|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
753183|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753184|NCT00006721|O3|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753185|NCT00006721|O2|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753186|NCT00006721|O1|Outcome|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the abs ence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
753187|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753188|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753189|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753190|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753191|NCT00006721|E3|Reported Event|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
753192|NCT00006721|E2|Reported Event|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
753193|NCT00006721|E1|Reported Event|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
753194|NCT00006478|B1|Baseline|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
753195|NCT00006478|P1|Participant Flow|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
753196|NCT00006478|O1|Outcome|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
753197|NCT00006478|E1|Reported Event|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
753198|NCT00006392|B5|Baseline|Total|Total of all reporting groups
753199|NCT00006392|B4|Baseline|Placebo|Matching placebo for vitamin E + matching placebo for selenium
753200|NCT00006392|B3|Baseline|Combination|Vitamin E + selenium
753201|NCT00006392|B2|Baseline|Selenium|Selenium + matching placebo for vitamin E
753202|NCT00006392|B1|Baseline|Vitamin E|Vitamin E + matching placebo for selenium
753203|NCT00006392|P4|Participant Flow|Placebo|Matching placebo for vitamin E + matching placebo for selenium
753204|NCT00006392|P3|Participant Flow|Combination|Vitamin E + selenium
753205|NCT00006392|P2|Participant Flow|Selenium|Selenium + matching placebo for vitamin E
753206|NCT00006392|P1|Participant Flow|Vitamin E|Vitamin E + matching placebo for selenium
753207|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
753208|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
753209|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
753210|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
753211|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
753212|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
753213|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
753214|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
753215|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
753216|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
753227|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
753228|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
753229|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
753230|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
753231|NCT00006392|E4|Reported Event|Vitamin E Alone|Vitamin E + placebo for selenium
753232|NCT00006392|E3|Reported Event|Placebo|Placebo for selenium + placebo for vitamin E
753233|NCT00006392|E2|Reported Event|Combination|Selenium + vitamin E
753234|NCT00006392|E1|Reported Event|Selenium Alone|Selenium + placebo for vitamin E
753235|NCT00006389|B1|Baseline|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
753236|NCT00006389|P1|Participant Flow|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
753237|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
753238|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
753239|NCT00006389|O1|Outcome|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
753240|NCT00006389|E1|Reported Event|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
753241|NCT00006244|B1|Baseline|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753242|NCT00006244|P1|Participant Flow|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753243|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753244|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753245|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753273|NCT00006110|O3|Outcome|Herceptin Regimen at 1.5 Years|Patients in the adjuvant and neoadjuvant groups.
753274|NCT00006110|O2|Outcome|Herceptin Regimen After TP|Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.
753246|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753247|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753248|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753249|NCT00006244|E1|Reported Event|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
753250|NCT00006237|B3|Baseline|Total|Total of all reporting groups
753251|NCT00006237|B2|Baseline|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
753252|NCT00006237|B1|Baseline|Interferon|interferon alfa
753253|NCT00006237|P2|Participant Flow|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
753254|NCT00006237|P1|Participant Flow|Interferon|interferon alfa IV
753255|NCT00006237|O2|Outcome|Biochemotherapy|Biochemotherapy
753256|NCT00006237|O1|Outcome|Interferon|Interferon
753257|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
753258|NCT00006237|O1|Outcome|Interferon|interferon alfa
753259|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
753260|NCT00006237|O1|Outcome|Interferon|interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
753261|NCT00006237|E2|Reported Event|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
753262|NCT00006237|E1|Reported Event|Interferon|interferon alfa
753263|NCT00006110|B3|Baseline|Total|Total of all reporting groups
753264|NCT00006110|B2|Baseline|Experimental: Non-Herceptin With or Without Radiation|Patients with high-risk human epidermal growth factor receptor 2 (HER-2) non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional Adriamycin/Cytoxan (4AC) followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
753265|NCT00006110|B1|Baseline|Experimental: Herceptin With or Without Radiation|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
753266|NCT00006110|P2|Participant Flow|Experimental: Non-Herceptin With or Without Radiation|Patients with high-risk human epidermal growth factor receptor 2 (HER-2) non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional 4AC followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
753267|NCT00006110|P1|Participant Flow|Experimental: Herceptin With or Without Radiation|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
753268|NCT00006110|O2|Outcome|Experimental: Non-Herceptin With or Without Radiation|Patients treated with AC chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)
753269|NCT00006110|O1|Outcome|Experimental: Herceptin With or Without Radiation|Patients who were given [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide) followed by paclitaxel + herceptin in both the neoadjuvant and the adjuvant groups.
753270|NCT00006110|O2|Outcome|Patients Treated With AC-P (Without Herceptin)|Patients treated with AC chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)
753271|NCT00006110|O1|Outcome|Patients Treated Neoadjuvantly With AC-TP|Patients who were given [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide) followed by paclitaxel + herceptin followed by surgery followed by radiation or no radiation followed by herceptin.
753272|NCT00006110|O4|Outcome|Herceptin Regimen|Worst per-patient toxicity: represents the number of patients who had cardiac toxicity at any time during the study regardless of subsequent recovery of function.
753275|NCT00006110|O1|Outcome|Herceptin Regimen After AC|Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).
753276|NCT00006110|E2|Reported Event|Control: Non-Herceptin|Patients with high-risk HER-2 non-overexpressing tumors and those whose tumors overexpress the protein but who refuse or are ineligible for Herceptin® will be treated with conventional 4AC followed by Taxol® without Herceptin®. This will be followed by surgery then either radiation or no radiation.
753277|NCT00006110|E1|Reported Event|Chemotherapy + Herceptin|Patients will receive Adriamycin/Cytoxan (4AC) followed by Taxol plus weekly Herceptin either neo-adjuvantly or adjuvantly. Eligible patients will go on to radiation then all patients will receive additional Herceptin every three weeks for 40 weeks.
753278|NCT00006101|B3|Baseline|Total|Total of all reporting groups
753279|NCT00006101|B2|Baseline|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
753280|NCT00006101|B1|Baseline|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of DFMO per day for 12 months"
753281|NCT00006101|P2|Participant Flow|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
753282|NCT00006101|P1|Participant Flow|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of eflornithine (Difluoromethylornithine) per day for 12 months"
753283|NCT00006101|O2|Outcome|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
753284|NCT00006101|O1|Outcome|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of DFMO per day for 12 months"
753285|NCT00006101|E2|Reported Event|Placebo|"placebo for 12 months~Placebo: Take placebo per day for 12 months"
753286|NCT00006101|E1|Reported Event|Eflornithine|"500mg/d for 12 months~eflornithine: Take 500mg of DFMO per day for 12 months"
753287|NCT00006011|B4|Baseline|Total|Total of all reporting groups
753288|NCT00006011|B3|Baseline|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
753289|NCT00006011|B2|Baseline|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
753290|NCT00006011|B1|Baseline|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
753291|NCT00006011|P3|Participant Flow|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
753292|NCT00006011|P2|Participant Flow|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
753293|NCT00006011|P1|Participant Flow|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
753294|NCT00006011|O2|Outcome|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
753295|NCT00006011|O1|Outcome|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
753296|NCT00006011|E2|Reported Event|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
753297|NCT00006011|E1|Reported Event|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
753298|NCT00005957|B3|Baseline|Total|Total of all reporting groups
753299|NCT00005957|B2|Baseline|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
753300|NCT00005957|B1|Baseline|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
753301|NCT00005957|P2|Participant Flow|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
753302|NCT00005957|P1|Participant Flow|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
753303|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
753304|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
753305|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
753306|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
753307|NCT00005957|E2|Reported Event|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.~Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment."
753337|NCT00005047|P3|Participant Flow|Arm III: Observation|Patients with unaltered (-) p53
753308|NCT00005957|E1|Reported Event|Standard Breast Irradiation|"radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.~Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment."
753309|NCT00005879|B3|Baseline|Total|Total of all reporting groups
753310|NCT00005879|B2|Baseline|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
753311|NCT00005879|B1|Baseline|Placebo|"Placebo~Placebo: matched tablet dialy"
753312|NCT00005879|P2|Participant Flow|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
753313|NCT00005879|P1|Participant Flow|Placebo|"Placebo~Placebo: matched tablet dialy"
753314|NCT00005879|O2|Outcome|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
753315|NCT00005879|O1|Outcome|Placebo|"Placebo~Placebo: matched tablet dialy"
753316|NCT00005879|O2|Outcome|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
753317|NCT00005879|O1|Outcome|Placebo|"Placebo~Placebo: matched tablet dialy"
753318|NCT00005879|E2|Reported Event|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
753319|NCT00005879|E1|Reported Event|Placebo|"Placebo~Placebo: matched tablet dialy"
753320|NCT00005803|B1|Baseline|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
753321|NCT00005803|P1|Participant Flow|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
753322|NCT00005803|O3|Outcome|Unknown Chemosensitivity Group|Patients who could not be evaluated for chemosensitivity.
753323|NCT00005803|O2|Outcome|Chemoresistant Group|Patients who were not CR or PR to most recent chemotherapy regimen.
753324|NCT00005803|O1|Outcome|Chemosensitive Group|Patients who were CR or PR to most recent chemotherapy regimen.
753325|NCT00005803|O3|Outcome|Unknown Chemosensitivity Group|Patients who could not be evaluated for chemosensitivity.
753326|NCT00005803|O2|Outcome|Chemoresistant Group|Patients who were not CR or PR to most recent chemotherapy regimen.
753327|NCT00005803|O1|Outcome|Chemosensitive Group|Patients who were CR or PR to most recent chemotherapy regimen.
753328|NCT00005803|O1|Outcome|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
753329|NCT00005803|O1|Outcome|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
753330|NCT00005803|E1|Reported Event|Treatment (Tandem Transplantation)|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous transplantation~Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-allogeneic tandem hematopoietic stem cell transplantation~Carmustine: Given IV~Cyclophosphamide: Given IV~Cyclosporine: Given PO~Cytarabine: Given IV~Etoposide: Given IV~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic transplantation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic transplantation~Therapeutic Autologous Lymphocytes: IV donor lymphocyte infusion~Total-Body Irradiation: Undergo radiotherapy"
753331|NCT00005047|B5|Baseline|Total|Total of all reporting groups
753332|NCT00005047|B4|Baseline|Arm IV: Observation|p53 positive, refused random assignment, assigned to observation/no intervention
753333|NCT00005047|B3|Baseline|Arm III: Observation|p53 negative, assigned to observation/no intervention
753334|NCT00005047|B2|Baseline|Arm II: Observation|p53 positive, randomized to observation/no intervention
753335|NCT00005047|B1|Baseline|Arm I: M-VAC x 3|p53 positive, randomized to 3 cycles of adjuvant combination methotrexate, vinblastine, doxorubicin and cisplatin (MVAC)
753336|NCT00005047|P4|Participant Flow|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
753338|NCT00005047|P2|Participant Flow|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
753339|NCT00005047|P1|Participant Flow|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
753340|NCT00005047|O2|Outcome|p53 Negative Patients|Arm III: Observation; Patients with unaltered (-) p53
753341|NCT00005047|O1|Outcome|p53 Positive Patients|"Arm I: Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~Arm II: Patients with altered (+) p53, reconsented to randomization, randomized to observation~Arm IV: Patients with altered (+) p53, patients did not consent to randomization"
753342|NCT00005047|O2|Outcome|p53 Negative Patients|Arm III: Observation; Patients with unaltered (-) p53
753343|NCT00005047|O1|Outcome|p53 Positive Patients|"Arm I: Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~Arm II: Patients with altered (+) p53, reconsented to randomization, randomized to observation~Arm IV: Patients with altered (+) p53, patients did not consent to randomization"
753344|NCT00005047|O2|Outcome|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
753345|NCT00005047|O1|Outcome|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
753346|NCT00005047|O2|Outcome|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
753347|NCT00005047|O1|Outcome|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
753348|NCT00005047|E4|Reported Event|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
753349|NCT00005047|E3|Reported Event|Arm III: Observation|Patients with unaltered (-) p53
753350|NCT00005047|E2|Reported Event|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
753351|NCT00005047|E1|Reported Event|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
753352|NCT00005044|B3|Baseline|Total|Total of all reporting groups
753353|NCT00005044|B2|Baseline|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753354|NCT00005044|B1|Baseline|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753355|NCT00005044|P2|Participant Flow|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753356|NCT00005044|P1|Participant Flow|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753357|NCT00005044|O2|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753358|NCT00005044|O1|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753359|NCT00005044|O2|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753360|NCT00005044|O1|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753361|NCT00005044|O2|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753362|NCT00005044|O1|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753363|NCT00005044|O2|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753364|NCT00005044|O1|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753365|NCT00005044|O2|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753366|NCT00005044|O1|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753367|NCT00005044|O2|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753368|NCT00005044|O1|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753369|NCT00005044|O2|Outcome|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753370|NCT00005044|O1|Outcome|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753371|NCT00005044|E2|Reported Event|TAS x 28 Weeks|TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753372|NCT00005044|E1|Reported Event|TAS x 8 Weeks|Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
753373|NCT00004888|B3|Baseline|Total|Total of all reporting groups
753374|NCT00004888|B2|Baseline|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753375|NCT00004888|B1|Baseline|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753376|NCT00004888|P2|Participant Flow|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753377|NCT00004888|P1|Participant Flow|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753378|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753379|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753380|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753381|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753382|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753383|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753384|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753385|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753386|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753387|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753388|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753389|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753390|NCT00004888|E2|Reported Event|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
753391|NCT00004888|E1|Reported Event|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
753392|NCT00004859|B3|Baseline|Total|Total of all reporting groups
753558|NCT00003782|B1|Baseline|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
753559|NCT00003782|P3|Participant Flow|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
753393|NCT00004859|B2|Baseline|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
753394|NCT00004859|B1|Baseline|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
753395|NCT00004859|P2|Participant Flow|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
753396|NCT00004859|P1|Participant Flow|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
753397|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
753398|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
753399|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
753400|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
753401|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
753402|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
753403|NCT00004859|E2|Reported Event|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
753404|NCT00004859|E1|Reported Event|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
753405|NCT00004259|B5|Baseline|Total|Total of all reporting groups
753406|NCT00004259|B4|Baseline|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
753407|NCT00004259|B3|Baseline|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
753408|NCT00004259|B2|Baseline|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
753409|NCT00004259|B1|Baseline|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
753410|NCT00004259|P4|Participant Flow|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
753411|NCT00004259|P3|Participant Flow|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
753412|NCT00004259|P2|Participant Flow|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
753413|NCT00004259|P1|Participant Flow|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
753414|NCT00004259|O2|Outcome|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
753415|NCT00004259|O1|Outcome|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
753416|NCT00004259|O2|Outcome|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
753417|NCT00004259|O1|Outcome|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
753418|NCT00004259|O2|Outcome|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
753419|NCT00004259|O1|Outcome|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
753420|NCT00004259|O2|Outcome|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
753421|NCT00004259|O1|Outcome|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
753422|NCT00004259|E4|Reported Event|Pilot Arm #2: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 150mg/m2 and TMZ 150mg/m2 six 8-week cycles
753423|NCT00004259|E3|Reported Event|Pilot Arm #1: RT+TMZ+BCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 200mg/m2 and TMZ 150mg/m2 six 6-week cycles
753424|NCT00004259|E2|Reported Event|RT + BCNU/CCNU|Radiation therapy for 6 weeks concurrent with and followed by BCNU 80mg/m2 or CCNU 130 mg/m2 for six 8-week cycles
753425|NCT00004259|E1|Reported Event|Radiation Therapy + Temozolomide (TMZ)|Radiation therapy (RT) for 6 weeks concurrent with and followed by TMZ 200mg/m2 for twelve 28-day cycles
753426|NCT00004228|B8|Baseline|Total|Total of all reporting groups
753474|NCT00004092|P2|Participant Flow|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753560|NCT00003782|P2|Participant Flow|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
753427|NCT00004228|B7|Baseline|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753428|NCT00004228|B6|Baseline|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753429|NCT00004228|B5|Baseline|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753430|NCT00004228|B4|Baseline|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753431|NCT00004228|B3|Baseline|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753432|NCT00004228|B2|Baseline|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
753433|NCT00004228|B1|Baseline|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
753434|NCT00004228|P7|Participant Flow|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753435|NCT00004228|P6|Participant Flow|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753475|NCT00004092|P1|Participant Flow|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753436|NCT00004228|P5|Participant Flow|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753437|NCT00004228|P4|Participant Flow|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753438|NCT00004228|P3|Participant Flow|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753439|NCT00004228|P2|Participant Flow|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
753440|NCT00004228|P1|Participant Flow|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
753441|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753442|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753443|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753444|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753476|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753565|NCT00003782|E3|Reported Event|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
753445|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753446|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
753447|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
753448|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753449|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753450|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753451|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753452|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753453|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
753454|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
753455|NCT00004228|E7|Reported Event|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753456|NCT00004228|E6|Reported Event|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753457|NCT00004228|E5|Reported Event|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753458|NCT00004228|E4|Reported Event|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
753459|NCT00004228|E3|Reported Event|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).
753460|NCT00004228|E2|Reported Event|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
753461|NCT00004228|E1|Reported Event|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
753462|NCT00004143|B1|Baseline|All Patients|
753463|NCT00004143|P1|Participant Flow|All Patients|
753464|NCT00004143|O1|Outcome|All Patients|
753465|NCT00004143|O1|Outcome|All Patients|
753466|NCT00004143|O1|Outcome|All Patients|
753467|NCT00004143|O1|Outcome|All Patients|
753468|NCT00004143|O1|Outcome|All Patients|
753469|NCT00004143|O1|Outcome|All Patients|
753470|NCT00004143|E1|Reported Event|All Patients|
753471|NCT00004092|B3|Baseline|Total|Total of all reporting groups
753472|NCT00004092|B2|Baseline|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753473|NCT00004092|B1|Baseline|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753561|NCT00003782|P1|Participant Flow|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
753562|NCT00003782|O3|Outcome|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
753563|NCT00003782|O2|Outcome|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
753477|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753478|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753479|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753480|NCT00004092|E2|Reported Event|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753481|NCT00004092|E1|Reported Event|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
753482|NCT00004054|B3|Baseline|Total|Total of all reporting groups
753483|NCT00004054|B2|Baseline|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753484|NCT00004054|B1|Baseline|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
753485|NCT00004054|P2|Participant Flow|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753486|NCT00004054|P1|Participant Flow|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
753487|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753488|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
753489|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753490|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
753491|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753492|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
753564|NCT00003782|O1|Outcome|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
753493|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753494|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
753495|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753496|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
753497|NCT00004054|E2|Reported Event|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
753498|NCT00004054|E1|Reported Event|Hormones and RT|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT.
753499|NCT00003910|B1|Baseline|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
753500|NCT00003910|P2|Participant Flow|Cyclophosphomide|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
753501|NCT00003910|P1|Participant Flow|Methotrexate|"MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. If patient had a partial response, MTX was continued for up to 1 year. If patient had CR, MTX was continued for 1 month.~If no response, then pt went onto step 2 and received CY."
753502|NCT00003910|O1|Outcome|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
753503|NCT00003910|E2|Reported Event|Cyclophosphamide|step 2 patients who received CY
753504|NCT00003910|E1|Reported Event|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
753505|NCT00003901|B1|Baseline|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
753506|NCT00003901|P1|Participant Flow|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
753507|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
753508|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
753509|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
753510|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
753511|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
753512|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
753513|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
753514|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
753515|NCT00003901|E1|Reported Event|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
753516|NCT00003896|B1|Baseline|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
753517|NCT00003896|P1|Participant Flow|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
753518|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Liposomal Doxorubicin|
753519|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
753520|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
753521|NCT00003896|E1|Reported Event|Paclitaxel/CDDP/Liposomal Doxorubicin|
753554|NCT00003820|E1|Reported Event|Rituximab 375 mg/m2 Per Week|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years.~This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group."
753522|NCT00003875|B1|Baseline|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
753523|NCT00003875|P1|Participant Flow|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
753524|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
753525|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
753526|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
753527|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
753528|NCT00003875|E1|Reported Event|Treatment|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
753529|NCT00003869|B3|Baseline|Total|Total of all reporting groups
753530|NCT00003869|B2|Baseline|Placebo|250 mg placebo administered daily
753531|NCT00003869|B1|Baseline|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753532|NCT00003869|P2|Participant Flow|Placebo|250 mg placebo administered daily
753533|NCT00003869|P1|Participant Flow|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753534|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
753535|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753536|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
753537|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753538|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
753539|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753540|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
753541|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753542|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
753543|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753544|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
753545|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753546|NCT00003869|E2|Reported Event|Placebo|250 mg placebo administered daily
753547|NCT00003869|E1|Reported Event|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
753548|NCT00003820|B1|Baseline|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 per week by IV infusion for 4 consecutive weeks
753549|NCT00003820|P2|Participant Flow|Rituximab 375 mg/m2 Per Week Secondary Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months~Secondary Group of participants were added after the addition of the three extra cycle treatments."
753550|NCT00003820|P1|Participant Flow|Rituximab 375 mg/m2 Per Week Inital Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months~Initial Group of participants prior to the addition of the three extra cycle treatments."
753551|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|375 mg/m2 rituximab by IV infusion weekly, assessed after 4 weeks of treatment
753552|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks
753553|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles
753555|NCT00003782|B4|Baseline|Total|Total of all reporting groups
753556|NCT00003782|B3|Baseline|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
753557|NCT00003782|B2|Baseline|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
753566|NCT00003782|E2|Reported Event|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
753567|NCT00003782|E1|Reported Event|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
753568|NCT00003702|B3|Baseline|Total|Total of all reporting groups
753569|NCT00003702|B2|Baseline|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
753570|NCT00003702|B1|Baseline|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
753571|NCT00003702|P2|Participant Flow|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
753572|NCT00003702|P1|Participant Flow|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
753573|NCT00003702|O1|Outcome|Enrolled Participants|Enrolled participants that had a subsequent hCG measurement after enrollment and before treatment
753574|NCT00003702|O2|Outcome|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
753575|NCT00003702|O1|Outcome|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
753576|NCT00003702|O2|Outcome|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
753577|NCT00003702|O1|Outcome|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
753578|NCT00003702|E2|Reported Event|Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks|Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
753579|NCT00003702|E1|Reported Event|Arm 1: Methotrexate 30 mg/m2 IM Weekly|Arm 1: Methotrexate 30 mg/m2 IM weekly
753580|NCT00003659|B1|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
753581|NCT00003659|P1|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
753582|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
753583|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
753584|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
753585|NCT00003659|E1|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
753586|NCT00003641|B3|Baseline|Total|Total of all reporting groups
753587|NCT00003641|B2|Baseline|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
753588|NCT00003641|B1|Baseline|Observation|Patients undergo observation for 4 weeks.
753589|NCT00003641|P2|Participant Flow|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
753590|NCT00003641|P1|Participant Flow|Observation|Patients undergo observation for 4 weeks.
753591|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
753592|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
753593|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
753594|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
753595|NCT00003641|E2|Reported Event|Interferon Alfa-2b|Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days
753596|NCT00003641|E1|Reported Event|Observation|Patients undergo observation for 4 weeks
753597|NCT00003631|B4|Baseline|Total|Total of all reporting groups
753598|NCT00003631|B3|Baseline|Group C - Unfavorable Prognostic Group|
753599|NCT00003631|B2|Baseline|Group B - Intermediate Prognostic Group|
753600|NCT00003631|B1|Baseline|Group A - Favorable Prognostic Group|
753601|NCT00003631|P3|Participant Flow|Group C - Unfavorable Prognostic Group|
753602|NCT00003631|P2|Participant Flow|Group B - Intermediate Prognostic Group|
753603|NCT00003631|P1|Participant Flow|Group A - Favorable Prognostic Group|
753604|NCT00003631|O3|Outcome|Group C - Unfavorable Prognostic Group|
753605|NCT00003631|O2|Outcome|Group B - Intermediate Prognostic Group|
753606|NCT00003631|O1|Outcome|Group A - Favorable Prognostic Group|
753607|NCT00003631|E3|Reported Event|Group C - Unfavorable Prognostic Group|
753608|NCT00003631|E2|Reported Event|Group B - Intermediate Prognostic Group|
753609|NCT00003631|E1|Reported Event|Group A - Favorable Prognostic Group|
753610|NCT00003590|B1|Baseline|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
753611|NCT00003590|P1|Participant Flow|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
753612|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
753613|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
753614|NCT00003590|E1|Reported Event|Hydroxyurea|Patients received Hydroxyurea (20 mg/kg/day orally) up to 2 years in absence of progressive disease.
753615|NCT00003537|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753616|NCT00003537|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753617|NCT00003537|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753618|NCT00003537|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753619|NCT00003537|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753620|NCT00003535|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753621|NCT00003535|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753622|NCT00003535|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753623|NCT00003535|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753624|NCT00003535|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753625|NCT00003483|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753626|NCT00003483|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753627|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753628|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753629|NCT00003483|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753630|NCT00003479|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753631|NCT00003479|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753771|NCT00003138|E2|Reported Event|Erythropoietin (Step 1)|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
753632|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753633|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753634|NCT00003479|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753635|NCT00003477|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
753636|NCT00003477|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
753637|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
753638|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
753639|NCT00003477|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a visual pathway glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
753640|NCT00003476|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753641|NCT00003476|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753642|NCT00003476|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753643|NCT00003476|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753644|NCT00003476|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753645|NCT00003475|B1|Baseline|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753646|NCT00003475|P1|Participant Flow|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753647|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753648|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753785|NCT00002874|B1|Baseline|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753649|NCT00003475|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753650|NCT00003474|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753651|NCT00003474|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753652|NCT00003474|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753653|NCT00003474|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753654|NCT00003474|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753655|NCT00003473|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753656|NCT00003473|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753657|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753658|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753659|NCT00003473|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753660|NCT00003472|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753661|NCT00003472|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753662|NCT00003472|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753786|NCT00002874|P2|Participant Flow|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753787|NCT00002874|P1|Participant Flow|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753663|NCT00003472|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753664|NCT00003472|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
753665|NCT00003471|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753666|NCT00003471|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753667|NCT00003471|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753668|NCT00003471|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753669|NCT00003471|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent/progressive low grade astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753670|NCT00003470|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753671|NCT00003470|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753672|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753673|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753674|NCT00003470|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753675|NCT00003469|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753788|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753789|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753676|NCT00003469|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753677|NCT00003469|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753678|NCT00003469|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753679|NCT00003469|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753680|NCT00003468|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753681|NCT00003468|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a low-grade astrocytoma who have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753682|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753683|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753684|NCT00003468|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753685|NCT00003460|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753686|NCT00003460|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753687|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753688|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753689|NCT00003460|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
753690|NCT00003459|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
753691|NCT00003459|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
753692|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
753693|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
753694|NCT00003459|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
753695|NCT00003458|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753696|NCT00003458|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753697|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753698|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753699|NCT00003458|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753700|NCT00003457|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753701|NCT00003457|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753702|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753703|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753704|NCT00003457|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
753705|NCT00003456|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753706|NCT00003456|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753707|NCT00003456|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753708|NCT00003456|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753790|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753709|NCT00003456|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753710|NCT00003453|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753711|NCT00003453|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753712|NCT00003453|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753713|NCT00003453|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753714|NCT00003453|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
753715|NCT00003389|B3|Baseline|Total|Total of all reporting groups
753716|NCT00003389|B2|Baseline|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
753717|NCT00003389|B1|Baseline|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
753718|NCT00003389|P2|Participant Flow|Arm B (Stanford V)|"Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Vincristine: given IV~Mechlorethamine: given IV~Etoposide: given IV~Prednisone: taken orally~Cyclophosphamide: given IV~Radiotherapy"
753719|NCT00003389|P1|Participant Flow|Arm A (ABVD)|"Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Dacarbazine: given IV~Radiotherapy"
753720|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
753721|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
753722|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
753723|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
753724|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
753725|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
753726|NCT00003389|E2|Reported Event|Arm B (Stanford V)|Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
753727|NCT00003389|E1|Reported Event|Arm A (ABVD)|Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
753728|NCT00003377|B6|Baseline|Total|Total of all reporting groups
753729|NCT00003377|B5|Baseline|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
753730|NCT00003377|B4|Baseline|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
753731|NCT00003377|B3|Baseline|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753732|NCT00003377|B2|Baseline|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753733|NCT00003377|B1|Baseline|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
753734|NCT00003377|P5|Participant Flow|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753735|NCT00003377|P4|Participant Flow|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
753736|NCT00003377|P3|Participant Flow|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
753737|NCT00003377|P2|Participant Flow|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753738|NCT00003377|P1|Participant Flow|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
753739|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753740|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753741|NCT00003377|O5|Outcome|Arm 2, PII|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753742|NCT00003377|O4|Outcome|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
753743|NCT00003377|O3|Outcome|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
753744|NCT00003377|O2|Outcome|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753745|NCT00003377|O1|Outcome|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
753746|NCT00003377|E5|Reported Event|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753747|NCT00003377|E4|Reported Event|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
753748|NCT00003377|E3|Reported Event|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
753749|NCT00003377|E2|Reported Event|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
753750|NCT00003377|E1|Reported Event|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
753791|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753751|NCT00003199|B1|Baseline|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
753752|NCT00003199|P1|Participant Flow|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
753753|NCT00003199|O1|Outcome|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
753754|NCT00003199|O1|Outcome|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
753755|NCT00003199|O1|Outcome|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
753756|NCT00003199|E1|Reported Event|TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
753757|NCT00003138|B3|Baseline|Total|Total of all reporting groups
753758|NCT00003138|B2|Baseline|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
753759|NCT00003138|B1|Baseline|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
753760|NCT00003138|P2|Participant Flow|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
753761|NCT00003138|P1|Participant Flow|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
753762|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
753763|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
753764|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
753765|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
753766|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
753767|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
753768|NCT00003138|E5|Reported Event|Erythropoietin (300 Units/kg) and Filgrastim (Step 4)|All patients received erythropoietin (150 units/kg) and filgrastim may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, increased their dose of erythropoietin to 300 units/kg.
753769|NCT00003138|E4|Reported Event|Erythropoietin (150 Units/kg) and Filgrastim (Step 3)|All patients received erythropoietin alone treatment may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, add filgrastim.
753770|NCT00003138|E3|Reported Event|Erythropoietin (Cross-over; Step 2)|Patients in the supportive care arm who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm. Erythropoietin was administered at 150 units/kg subcutaneously every day.
755840|NCT00041756|E5|Reported Event|200 mg PG-530742|200 mg PG-530742 dosed BID
753772|NCT00003138|E1|Reported Event|Supportive Care (Step 1)|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
753773|NCT00002975|B1|Baseline|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
753774|NCT00002975|P1|Participant Flow|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
753775|NCT00002975|O1|Outcome|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
753776|NCT00002975|E1|Reported Event|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
753777|NCT00002931|B1|Baseline|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
753778|NCT00002931|P1|Participant Flow|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
753779|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
753780|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
753781|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
753782|NCT00002931|E1|Reported Event|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
753783|NCT00002874|B3|Baseline|Total|Total of all reporting groups
753784|NCT00002874|B2|Baseline|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753792|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753793|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753794|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753795|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753796|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753797|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753798|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753799|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753800|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753801|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753802|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753803|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753804|NCT00002874|O2|Outcome|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753805|NCT00002874|O1|Outcome|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753806|NCT00002874|E2|Reported Event|Bicalutamide|Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
753807|NCT00002874|E1|Reported Event|Placebo|Radiation therapy (64.8 Gy) + placebo (daily 2 years)
753808|NCT00002850|B4|Baseline|Total|Total of all reporting groups
753809|NCT00002850|B3|Baseline|Observation|No prophylaxis: The patient will receive no prophylactic antibiotics.
753810|NCT00002850|B2|Baseline|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
753811|NCT00002850|B1|Baseline|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
753812|NCT00002850|P3|Participant Flow|Observation|Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.
753813|NCT00002850|P2|Participant Flow|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
753814|NCT00002850|P1|Participant Flow|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
753815|NCT00002850|O3|Outcome|No Prophylaxis|The patient will receive no prophylactic antibiotics.
753816|NCT00002850|O2|Outcome|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
753817|NCT00002850|O1|Outcome|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
753818|NCT00002850|E3|Reported Event|Observation|No Prophylaxis: The patient will receive no prophylactic antibiotics.
753819|NCT00002850|E2|Reported Event|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
753820|NCT00002850|E1|Reported Event|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
753821|NCT00002842|B1|Baseline|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
753866|NCT00052078|B2|Baseline|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
755841|NCT00041756|E4|Reported Event|100 mg PG-530742|100 mg PG-530742 dosed BID
753822|NCT00002842|P1|Participant Flow|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
753823|NCT00002842|O1|Outcome|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
753824|NCT00002842|E1|Reported Event|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
753825|NCT00002766|B3|Baseline|Total|Total of all reporting groups
753826|NCT00002766|B2|Baseline|L-20|"Standard Vincristine/Prednisone (L-20)"
753827|NCT00002766|B1|Baseline|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
753828|NCT00002766|P2|Participant Flow|L-20|"Standard Vincristine/Prednisone (L-20) Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover."
753829|NCT00002766|P1|Participant Flow|All-2|"ARA-C/High-Dose Mitoxantrone(All-2) Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover."
753830|NCT00002766|O2|Outcome|L-20|"Standard Vincristine/Prednisone (L-20)"
753831|NCT00002766|O1|Outcome|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
753832|NCT00002766|E2|Reported Event|L-20|"Standard Vincristine/Prednisone (L-20)"
753833|NCT00002766|E1|Reported Event|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
753834|NCT00002651|B3|Baseline|Total|Total of all reporting groups
753835|NCT00002651|B2|Baseline|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753836|NCT00002651|B1|Baseline|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753837|NCT00002651|P3|Participant Flow|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753838|NCT00002651|P2|Participant Flow|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753839|NCT00002651|P1|Participant Flow|Combined Androgen Deprivation (CAD)|Patients receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily for 7 months.
753840|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753841|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753867|NCT00052078|B1|Baseline|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
753868|NCT00052078|P4|Participant Flow|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
753923|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753924|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753842|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753843|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753844|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753845|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753846|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753847|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753848|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753849|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753850|NCT00002651|O2|Outcome|Consolidation Arm II|"Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.~bicalutamide: Given orally~goserelin acetate: Given subcutaneously~clinical observation: Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease."
753851|NCT00002651|O1|Outcome|Consolidation Arm I|"Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.~bicalutamide: Given orally~goserelin acetate: Given subcutaneously"
753852|NCT00002651|E2|Reported Event|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
753853|NCT00002651|E1|Reported Event|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
753854|NCT00002558|B3|Baseline|Total|Total of all reporting groups
753855|NCT00002558|B2|Baseline|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
753856|NCT00002558|B1|Baseline|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
753857|NCT00002558|P2|Participant Flow|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
753858|NCT00002558|P1|Participant Flow|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
753859|NCT00002558|O2|Outcome|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
753860|NCT00002558|O1|Outcome|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
753861|NCT00002558|E2|Reported Event|Group: B > 6 Cycles of Cisplatin|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
753862|NCT00002558|E1|Reported Event|Group A: <= 6 Cycles of Cisplatin|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
753863|NCT00052078|B5|Baseline|Total|Total of all reporting groups
753864|NCT00052078|B4|Baseline|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
753865|NCT00052078|B3|Baseline|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
755842|NCT00041756|E3|Reported Event|50 mg PG-530742|50 mg PG-530742 dosed BID
753869|NCT00052078|P3|Participant Flow|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
753870|NCT00052078|P2|Participant Flow|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
753871|NCT00052078|P1|Participant Flow|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
753872|NCT00052078|O4|Outcome|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
753873|NCT00052078|O3|Outcome|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
753874|NCT00052078|O2|Outcome|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
753875|NCT00052078|O1|Outcome|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
753876|NCT00052078|E4|Reported Event|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
753877|NCT00052078|E3|Reported Event|3 Combination Setraline + CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
753878|NCT00052078|E2|Reported Event|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
753879|NCT00052078|E1|Reported Event|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
753880|NCT00051636|B3|Baseline|Total|Total of all reporting groups
753881|NCT00051636|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753882|NCT00051636|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753883|NCT00051636|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753884|NCT00051636|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753885|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753886|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753887|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753888|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753889|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753890|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753891|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753892|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753893|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753894|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753895|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753896|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753897|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753898|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753899|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753900|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753901|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753902|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753903|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753904|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753905|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753906|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753907|NCT00051636|E2|Reported Event|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753908|NCT00051636|E1|Reported Event|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
753909|NCT00051558|B3|Baseline|Total|Total of all reporting groups
753910|NCT00051558|B2|Baseline|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753911|NCT00051558|B1|Baseline|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753912|NCT00051558|P2|Participant Flow|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753913|NCT00051558|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753914|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753915|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753916|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753917|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753918|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753919|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753920|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753921|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753922|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753925|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753926|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753927|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753928|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753929|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753930|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753931|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753932|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753933|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753934|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753935|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753936|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753937|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753938|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753939|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753940|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753941|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753942|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753943|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753944|NCT00051558|E2|Reported Event|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
753945|NCT00051558|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
753946|NCT00051363|B3|Baseline|Total|Total of all reporting groups
753947|NCT00051363|B2|Baseline|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753948|NCT00051363|B1|Baseline|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753949|NCT00051363|P2|Participant Flow|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753950|NCT00051363|P1|Participant Flow|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753951|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753952|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753953|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753954|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753955|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753956|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753957|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753958|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753959|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753960|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753961|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753962|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753963|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753964|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753965|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753966|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753967|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753968|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753969|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753970|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753971|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
755363|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
753972|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753973|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753974|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753975|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753976|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753977|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753978|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753979|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753980|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753981|NCT00051363|E2|Reported Event|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
753982|NCT00051363|E1|Reported Event|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
753983|NCT00051168|B1|Baseline|Travatan|Travoprost (0.004%)
753984|NCT00051168|P1|Participant Flow|Travatan|Travoprost (0.004%)
753985|NCT00051168|O1|Outcome|Travatan|Travoprost (0.004%)
753986|NCT00051168|E1|Reported Event|Travatan|Travoprost (0.004%)
753987|NCT00051025|B3|Baseline|Total|Total of all reporting groups
753988|NCT00051025|B2|Baseline|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753989|NCT00051025|B1|Baseline|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753990|NCT00051025|P2|Participant Flow|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753991|NCT00051025|P1|Participant Flow|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753992|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753993|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753994|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753995|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753996|NCT00051025|E2|Reported Event|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753997|NCT00051025|E1|Reported Event|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
753998|NCT00050986|B1|Baseline|Temozolomide and R115777|
753999|NCT00050986|P1|Participant Flow|Temozolomide and R115777|
754000|NCT00050986|O1|Outcome|Temozolomide and R115777|
754001|NCT00050986|E1|Reported Event|Temozolomide and R115777|
754002|NCT00050960|B3|Baseline|Total|Total of all reporting groups
754003|NCT00050960|B2|Baseline|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
754004|NCT00050960|B1|Baseline|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
754005|NCT00050960|P2|Participant Flow|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
754006|NCT00050960|P1|Participant Flow|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
754007|NCT00050960|O2|Outcome|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
754008|NCT00050960|O1|Outcome|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
754009|NCT00050960|E2|Reported Event|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
754010|NCT00050960|E1|Reported Event|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
754011|NCT00050778|B4|Baseline|Total|Total of all reporting groups
754012|NCT00050778|B3|Baseline|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754013|NCT00050778|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754014|NCT00050778|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
754015|NCT00050778|P3|Participant Flow|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754016|NCT00050778|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the cluster of differentiation 4+ [CD4+] T-cell count was >=100*10^6 cells per liter).
754017|NCT00050778|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 micrograms (mcg) subcutaneously 3-times weekly for 36 months.
754018|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754019|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754020|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754021|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
754022|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754023|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754024|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754025|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
754026|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754027|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754028|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754029|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
754030|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754031|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754032|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754033|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
754034|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754035|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754036|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754037|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
754038|NCT00050778|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754039|NCT00050778|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754040|NCT00050778|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
754041|NCT00050778|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
754042|NCT00050622|B1|Baseline|Within-Subject Treatment|All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication.
754043|NCT00050622|P1|Participant Flow|Within-Subject Treatment|All subjects received a within-subjects crossover of 3 levels of behavior modification, randomized in 3-week units, and 4 levels of medication, randomized on a daily basis. Thus each participant experienced all 12 combinations of No, Low, and High Intensity BMOD crossed with Placebo, 0.15 mg/kg MPH, 0.3 mg/kg MPH, and 0.6 mg/kg MPH conditions, with specific conditions changing daily.
754044|NCT00050622|O6|Outcome|High Intensity BMOD + Medication|High Intensity BMOD + Medication (any dose)
754045|NCT00050622|O5|Outcome|Low Intensity BMOD + Med|Low intensity behavior modification + medication (any dose)
754046|NCT00050622|O4|Outcome|Medication Only|No BMOD + Medication (any dose)
754047|NCT00050622|O3|Outcome|High Intensity BMOD ONly|
754048|NCT00050622|O2|Outcome|Low Intensity BMOD Only|
754049|NCT00050622|O1|Outcome|No Treatment|No BMOD, No medication
754050|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
754051|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
754052|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
754053|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD~High Intensity BMOD: Comprehensive high-intensity STP"
754054|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754055|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754056|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~Low-Intensity BMOD: Lower-intensity behavioral treatment package."
754057|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Placebo"
754058|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754059|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754060|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
754061|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD~Placebo"
754062|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
754063|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
754064|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
754065|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD~High Intensity BMOD: Comprehensive high-intensity STP"
754066|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754067|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754068|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~Low-Intensity BMOD: Lower-intensity behavioral treatment package."
754069|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Placebo"
754070|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754071|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
754072|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
754073|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD~Placebo"
754074|NCT00050622|E4|Reported Event|Higher Dose Medication|0.6 mg/kg MPH, No BMOD
754075|NCT00050622|E3|Reported Event|Medium Dose Medication|0.3 mg/kg MPH, No BMOD
754076|NCT00050622|E2|Reported Event|Low Dose Medication|0.15 mg/kg MPH, No BMOD
754077|NCT00050622|E1|Reported Event|Placebo|Placebo
754078|NCT00050167|B3|Baseline|Total|Total of all reporting groups
754079|NCT00050167|B2|Baseline|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
754080|NCT00050167|B1|Baseline|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
754081|NCT00050167|P2|Participant Flow|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
754082|NCT00050167|P1|Participant Flow|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
754083|NCT00050167|O2|Outcome|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
755364|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
754084|NCT00050167|O1|Outcome|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
754085|NCT00050167|E2|Reported Event|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
754086|NCT00050167|E1|Reported Event|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
754087|NCT00050089|B5|Baseline|Total|Total of all reporting groups
754088|NCT00050089|B4|Baseline|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
754089|NCT00050089|B3|Baseline|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
754090|NCT00050089|B2|Baseline|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
754091|NCT00050089|B1|Baseline|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
754092|NCT00050089|P4|Participant Flow|ARDFP+Mega-ART|"Antiretroviral Drug-Free Period (ARDFP) and Mega-ART~Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs"
754093|NCT00050089|P3|Participant Flow|ARDFP+Standard-ART|"Antiretroviral Drug-Free Period (ARDFP) and Standard-ART~Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs"
754094|NCT00050089|P2|Participant Flow|No ARDFP+Mega-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART~Mega-ART: 5 or more anti-HIV drugs"
754095|NCT00050089|P1|Participant Flow|No ARDFP+Standard-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART~Standard-ART: up to 4 anti-HIV drugs"
754096|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
754097|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
754098|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
754099|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
754100|NCT00050089|O4|Outcome|ARDFP + Mega ART|Intensive ART following ART interruption
754101|NCT00050089|O3|Outcome|ARDFP + Standard ART|Standard ART regimen following ART interruption
754102|NCT00050089|O2|Outcome|No ARDFP + Mega ART|Intensive ART regimen, with no prior ART interruption
754103|NCT00050089|O1|Outcome|No ARDFP + Standard ART|Standard ART regimen, with no prior ART interruption
754104|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
754105|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
754106|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
754107|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
754108|NCT00050089|E4|Reported Event|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
754109|NCT00050089|E3|Reported Event|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
754110|NCT00050089|E2|Reported Event|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
754111|NCT00050089|E1|Reported Event|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
754112|NCT00050011|B3|Baseline|Total|Total of all reporting groups
754113|NCT00050011|B2|Baseline|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
754114|NCT00050011|B1|Baseline|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
754115|NCT00050011|P2|Participant Flow|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
754116|NCT00050011|P1|Participant Flow|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754117|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754830|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754118|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754119|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754120|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754121|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754122|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754123|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754124|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754125|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754126|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754127|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754128|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754129|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754831|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754130|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754131|NCT00050011|O2|Outcome|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754132|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754133|NCT00050011|E2|Reported Event|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
754134|NCT00050011|E1|Reported Event|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Femara 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
754135|NCT00049842|B3|Baseline|Total|Total of all reporting groups
754136|NCT00049842|B2|Baseline|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754137|NCT00049842|B1|Baseline|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754138|NCT00049842|P2|Participant Flow|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754139|NCT00049842|P1|Participant Flow|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754140|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754141|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754142|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754143|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754144|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754145|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754146|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754147|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754148|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754149|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754150|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
754151|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
754152|NCT00049842|E2|Reported Event|Untreated Control|
754153|NCT00049842|E1|Reported Event|PEG-Intron|
754154|NCT00048932|B3|Baseline|Total|Total of all reporting groups
754155|NCT00048932|B2|Baseline|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754156|NCT00048932|B1|Baseline|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754157|NCT00048932|P3|Participant Flow|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754832|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754158|NCT00048932|P2|Participant Flow|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754159|NCT00048932|P1|Participant Flow|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754160|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754161|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754162|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754163|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754164|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754165|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754166|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754167|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754168|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754169|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754170|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754171|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754172|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754173|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754174|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754175|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754176|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754177|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754178|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
755365|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
754179|NCT00048932|E3|Reported Event|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754180|NCT00048932|E2|Reported Event|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for subjects < 60 kg, 750 mg for subjects 60 to 100 kg and 1 g for subjects > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
754181|NCT00048932|E1|Reported Event|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
754182|NCT00048815|B4|Baseline|Total|Total of all reporting groups
754183|NCT00048815|B3|Baseline|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
754184|NCT00048815|B2|Baseline|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
754185|NCT00048815|B1|Baseline|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
754186|NCT00048815|P3|Participant Flow|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
754187|NCT00048815|P2|Participant Flow|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
754188|NCT00048815|P1|Participant Flow|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
754189|NCT00048815|O3|Outcome|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
754190|NCT00048815|O2|Outcome|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
754191|NCT00048815|O1|Outcome|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
754192|NCT00048815|O3|Outcome|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
754193|NCT00048815|O2|Outcome|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
754194|NCT00048815|O1|Outcome|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
754195|NCT00048815|E3|Reported Event|Placebo|Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
754196|NCT00048815|E2|Reported Event|St. John's Wort|Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
754197|NCT00048815|E1|Reported Event|Citalopram|Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
754198|NCT00048581|B3|Baseline|Total|Total of all reporting groups
754199|NCT00048581|B2|Baseline|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754200|NCT00048581|B1|Baseline|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754201|NCT00048581|P3|Participant Flow|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
754202|NCT00048581|P2|Participant Flow|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754203|NCT00048581|P1|Participant Flow|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754204|NCT00048581|O1|Outcome|All Treated Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754205|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
755366|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
754206|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754207|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754208|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754209|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754210|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754211|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754212|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754213|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754214|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754215|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754216|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754217|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754218|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754219|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754220|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754221|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754222|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754223|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754224|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754225|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754226|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754227|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754228|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754229|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754447|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754230|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754231|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754232|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754233|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754234|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754235|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754236|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754237|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754238|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754239|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754240|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754241|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754242|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754243|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754244|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754245|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754246|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754247|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754248|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754249|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754250|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754251|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754252|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754253|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754517|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754254|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754255|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754256|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754257|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754258|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754259|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754260|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754261|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754262|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754263|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754264|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754265|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754266|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754267|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754268|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754269|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754270|NCT00048581|O1|Outcome|OL: ABA|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754271|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754272|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754273|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754274|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754275|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754276|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754277|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754278|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754279|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754280|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754281|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754282|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754283|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754284|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754285|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754286|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754287|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754288|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754289|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754290|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
754291|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
754292|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
754293|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
754294|NCT00048581|O1|Outcome|All Treated DB Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754295|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
754296|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754297|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754298|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754299|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754300|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754301|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754302|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754303|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754304|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754305|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754306|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754307|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754308|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754309|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754310|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754311|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754312|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754313|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754314|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754315|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754316|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754317|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754318|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754319|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754320|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754321|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754322|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754323|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754324|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754325|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754326|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754327|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754328|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754329|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754330|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754331|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754332|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754333|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754334|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754335|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754336|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754337|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754338|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754339|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754340|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754341|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754342|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754343|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754344|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754345|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754346|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754347|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754348|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754349|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754350|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754351|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754352|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754353|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754354|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754355|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754356|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754357|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754358|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754359|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754360|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754361|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754362|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754363|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754364|NCT00048581|E3|Reported Event|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
754365|NCT00048581|E2|Reported Event|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
754366|NCT00048581|E1|Reported Event|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
754367|NCT00048568|B3|Baseline|Total|Total of all reporting groups
754368|NCT00048568|B2|Baseline|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754369|NCT00048568|B1|Baseline|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754370|NCT00048568|P3|Participant Flow|ABA + MTX [Open-label (OL)]|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754371|NCT00048568|P2|Participant Flow|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754372|NCT00048568|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
754373|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754374|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754375|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754376|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754377|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754378|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754379|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754380|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754381|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754833|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754382|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754383|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754384|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754385|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754386|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754387|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754388|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754389|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754390|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754391|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754392|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754393|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754394|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754395|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754396|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754397|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754398|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754399|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754400|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754401|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754402|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754403|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754404|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754405|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754406|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754407|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754408|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754409|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754410|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754411|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754412|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754413|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754414|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754518|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754415|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754416|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754417|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754418|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754419|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754420|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754421|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754422|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754423|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754424|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754425|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754426|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754427|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754428|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754429|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754430|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754519|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754431|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754432|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754433|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754434|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754435|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754436|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754437|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754438|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754439|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754440|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754441|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754442|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754443|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754444|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754445|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754446|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
755142|NCT00046475|E2|Reported Event|Titration|Patients received different doses of drug for at least 2 weeks to determine the maximum tolerated dose.
754448|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754449|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754450|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754451|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754452|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754453|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754454|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754455|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754456|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754457|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754458|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754459|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754460|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754461|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754462|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754463|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754464|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754465|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754466|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
755184|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
754467|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754468|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754469|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754470|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754471|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754472|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754473|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754474|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754475|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754476|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754477|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754478|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754479|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754480|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754481|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754482|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754520|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754483|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754484|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754485|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754486|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754487|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754488|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754489|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754490|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754491|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754492|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754493|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754494|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754495|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754496|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754497|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754498|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754521|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754499|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754500|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754501|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754502|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754503|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754504|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754505|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754506|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754507|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754508|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754509|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754510|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754511|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754512|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754513|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754514|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754515|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754516|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
755313|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
754522|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754523|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754524|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754525|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754526|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754527|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754528|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754529|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754530|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754531|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754532|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754533|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754534|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754535|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754536|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754537|NCT00048568|O1|Outcome|ABA + MTX Cumulative DB + OL Periods|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB and OL periods under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754538|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
755314|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
754539|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754540|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754541|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754542|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754543|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754544|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754545|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754546|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754547|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754548|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754549|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754550|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754551|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754552|NCT00048568|O2|Outcome|MTX + Placebo|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754553|NCT00048568|O1|Outcome|ABA + MTX|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754554|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754555|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754556|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754557|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754558|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754559|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754560|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754561|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754562|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754563|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754564|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754565|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754566|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754567|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754568|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754569|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754570|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754618|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754571|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754572|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
754573|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754574|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754575|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754576|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754577|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754578|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754579|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754580|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754581|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754582|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754583|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754584|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754585|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754586|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754834|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754587|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754588|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754589|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754590|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754591|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754592|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754593|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754594|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754595|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754596|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754597|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754598|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754599|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754600|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754601|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754602|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754603|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754604|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754605|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754606|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754607|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754608|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754609|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754610|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754611|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754612|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754613|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754614|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754615|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754616|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754617|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754835|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754619|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754620|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754621|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754622|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754623|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754624|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754625|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754626|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754627|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754628|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754629|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754630|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754631|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754632|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754633|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
755087|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
754634|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754635|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754636|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754637|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754638|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754639|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754640|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754641|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754642|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754643|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754644|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754645|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754646|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754647|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
754648|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754649|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
755367|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
754650|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754651|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754652|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754653|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754654|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754655|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754656|NCT00048568|E3|Reported Event|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
754657|NCT00048568|E2|Reported Event|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
754658|NCT00048568|E1|Reported Event|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
754659|NCT00048893|B1|Baseline|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754660|NCT00048893|P1|Participant Flow|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754661|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754662|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754663|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754664|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754665|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754666|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754667|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754668|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754669|NCT00048893|E1|Reported Event|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
754670|NCT00048737|B1|Baseline|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
754671|NCT00048737|P1|Participant Flow|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
754672|NCT00048737|O1|Outcome|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab: 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
754673|NCT00048737|E1|Reported Event|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
754674|NCT00048724|B3|Baseline|Total|Total of all reporting groups
754675|NCT00048724|B2|Baseline|Untreated Control|
754676|NCT00048724|B1|Baseline|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
754677|NCT00048724|P2|Participant Flow|Untreated Control|
754678|NCT00048724|P1|Participant Flow|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
754679|NCT00048724|O2|Outcome|Untreated Control|
754680|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
754681|NCT00048724|O2|Outcome|Untreated Control|
754682|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
754683|NCT00048724|E2|Reported Event|Untreated Control|
754684|NCT00048724|E1|Reported Event|PegIntron|
754685|NCT00048542|B5|Baseline|Total|Total of all reporting groups
754686|NCT00048542|B4|Baseline|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754687|NCT00048542|B3|Baseline|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754688|NCT00048542|B2|Baseline|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
754689|NCT00048542|B1|Baseline|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
754690|NCT00048542|P8|Participant Flow|Open-Label Extension FD Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754691|NCT00048542|P7|Participant Flow|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754692|NCT00048542|P6|Participant Flow|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
754693|NCT00048542|P5|Participant Flow|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
754694|NCT00048542|P4|Participant Flow|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754695|NCT00048542|P3|Participant Flow|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754717|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
755088|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
754696|NCT00048542|P2|Participant Flow|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
754697|NCT00048542|P1|Participant Flow|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
754698|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754699|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754700|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754701|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754702|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754703|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754704|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754705|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754706|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754707|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754708|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754709|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754710|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754711|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754712|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754713|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754714|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754715|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754716|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754718|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754719|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
754720|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
754721|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
754722|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
754723|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
754724|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
754725|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
754726|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
754727|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
754728|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
754729|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
754730|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
754731|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
754732|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
754733|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
754734|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
754735|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
754736|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
754737|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
754738|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
754739|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
754740|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
754741|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
754742|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
754743|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
754744|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
754745|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
754746|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754747|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754748|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
754749|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
755089|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
754750|NCT00048542|O2|Outcome|Adalimumab|Subjects received open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]), but no methotrexate (MTX), during the Open-Label Lead-In (OL-LI) Phase of the study.
754751|NCT00048542|O1|Outcome|Adalimumab + MTX|Subjects received methotrexate (MTX) plus open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]) during the Open-Label Lead-In (OL-LI) Phase of the study.
754752|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754753|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754754|NCT00048542|E8|Reported Event|Open-Label Extension FD Adalimumab|Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754755|NCT00048542|E7|Reported Event|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
754756|NCT00048542|E6|Reported Event|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
754757|NCT00048542|E5|Reported Event|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
754758|NCT00048542|E4|Reported Event|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754759|NCT00048542|E3|Reported Event|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
754760|NCT00048542|E2|Reported Event|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
754761|NCT00048542|E1|Reported Event|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
754762|NCT00048347|B1|Baseline|Avonex|30 µg IM every week for 12 weeks
754763|NCT00048347|P1|Participant Flow|Avonex|30 µg IM every week for 12 weeks
754764|NCT00048347|O1|Outcome|Avonex|30 µg IM every week for 12 weeks
754765|NCT00048347|E1|Reported Event|Avonex|30 µg IM every week for 12 weeks
754766|NCT00048165|B3|Baseline|Total|Total of all reporting groups
754767|NCT00048165|B2|Baseline|Placebo|Eligible participants were administered an intravenous matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754768|NCT00048165|B1|Baseline|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754769|NCT00048165|P2|Participant Flow|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
755090|NCT00047619|E2|Reported Event|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
754770|NCT00048165|P1|Participant Flow|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754771|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754772|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754773|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754774|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754775|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754776|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754777|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754778|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754779|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754780|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754781|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754782|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754783|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754828|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
755843|NCT00041756|E2|Reported Event|25 mg PG-530742|25 mg PG-530742 dosed BID
754784|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754785|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754786|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754787|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754788|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754789|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754790|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754791|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754792|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754793|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754794|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754795|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754796|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754797|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754829|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754798|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754799|NCT00048165|E2|Reported Event|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754800|NCT00048165|E1|Reported Event|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
754801|NCT00048074|B4|Baseline|Total|Total of all reporting groups
754802|NCT00048074|B3|Baseline|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754803|NCT00048074|B2|Baseline|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754804|NCT00048074|B1|Baseline|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754805|NCT00048074|P3|Participant Flow|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754806|NCT00048074|P2|Participant Flow|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754807|NCT00048074|P1|Participant Flow|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754808|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754809|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754810|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754811|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754812|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754813|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754814|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754815|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754816|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754817|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754818|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754819|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754820|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754821|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754822|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754823|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754824|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754825|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754826|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754827|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
755091|NCT00047619|E1|Reported Event|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
754836|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754837|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754838|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754839|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754840|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754841|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754842|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754843|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754844|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754845|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754846|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754847|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754848|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754849|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754850|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754851|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754852|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754853|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754854|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754855|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754856|NCT00048074|E3|Reported Event|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
754857|NCT00048074|E2|Reported Event|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
754858|NCT00048074|E1|Reported Event|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
754859|NCT00048061|B5|Baseline|Total|Total of all reporting groups
754860|NCT00048061|B4|Baseline|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754861|NCT00048061|B3|Baseline|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754862|NCT00048061|B2|Baseline|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754863|NCT00048061|B1|Baseline|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754864|NCT00048061|P4|Participant Flow|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754865|NCT00048061|P3|Participant Flow|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754866|NCT00048061|P2|Participant Flow|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754867|NCT00048061|P1|Participant Flow|Ibandronate 2.5 mg|Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
755092|NCT00047463|B3|Baseline|Total|Total of all reporting groups
755315|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
754868|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754869|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754870|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754871|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754872|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754873|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754874|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754875|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754876|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754877|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754878|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754879|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754880|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754881|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754882|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754883|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754884|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754885|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754886|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754887|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754888|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754889|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754890|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754891|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754892|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754893|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754894|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754895|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754896|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
755138|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
754897|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754898|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754899|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754900|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754901|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754902|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754903|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754904|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754905|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754906|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754907|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754908|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754909|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754910|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754911|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754912|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754913|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754914|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754915|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754916|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754917|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754918|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754919|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754920|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754921|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754922|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754923|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754924|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754925|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
755316|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
754926|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754927|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754928|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754929|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754930|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754931|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754932|NCT00048061|E4|Reported Event|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754933|NCT00048061|E3|Reported Event|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754934|NCT00048061|E2|Reported Event|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754935|NCT00048061|E1|Reported Event|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
754936|NCT00048048|B10|Baseline|Total|Total of all reporting groups
754937|NCT00048048|B9|Baseline|Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754938|NCT00048048|B8|Baseline|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754939|NCT00048048|B7|Baseline|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754940|NCT00048048|B6|Baseline|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754941|NCT00048048|B5|Baseline|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754942|NCT00048048|B4|Baseline|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period
754943|NCT00048048|B3|Baseline|Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754944|NCT00048048|B2|Baseline|Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754945|NCT00048048|B1|Baseline|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754946|NCT00048048|P12|Participant Flow|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754947|NCT00048048|P11|Participant Flow|RO0503821 (1x/2Week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755844|NCT00041756|E1|Reported Event|Placebo Tablet|Placebo tablet dosed BID
754948|NCT00048048|P10|Participant Flow|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754949|NCT00048048|P9|Participant Flow|Cohort 9 (RO0503821, 1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754950|NCT00048048|P8|Participant Flow|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754951|NCT00048048|P7|Participant Flow|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754952|NCT00048048|P6|Participant Flow|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754953|NCT00048048|P5|Participant Flow|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754954|NCT00048048|P4|Participant Flow|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754955|NCT00048048|P3|Participant Flow|Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754956|NCT00048048|P2|Participant Flow|Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754957|NCT00048048|P1|Participant Flow|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754958|NCT00048048|O9|Outcome|Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754959|NCT00048048|O8|Outcome|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754960|NCT00048048|O7|Outcome|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754961|NCT00048048|O6|Outcome|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754962|NCT00048048|O5|Outcome|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754963|NCT00048048|O4|Outcome|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754964|NCT00048048|O3|Outcome|Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754965|NCT00048048|O2|Outcome|Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754966|NCT00048048|O1|Outcome|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754967|NCT00048048|O3|Outcome|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754968|NCT00048048|O2|Outcome|RO0503821 (1x/2week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754969|NCT00048048|O1|Outcome|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754970|NCT00048048|O3|Outcome|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754971|NCT00048048|O2|Outcome|RO0503821 (1x/2week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754972|NCT00048048|O1|Outcome|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754973|NCT00048048|O3|Outcome|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754974|NCT00048048|O2|Outcome|RO0503821 (1x/2Week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754975|NCT00048048|O1|Outcome|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754976|NCT00048048|O9|Outcome|Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754977|NCT00048048|O8|Outcome|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754978|NCT00048048|O7|Outcome|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754979|NCT00048048|O6|Outcome|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754980|NCT00048048|O5|Outcome|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754981|NCT00048048|O4|Outcome|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755317|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
754982|NCT00048048|O3|Outcome|Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754983|NCT00048048|O2|Outcome|Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754984|NCT00048048|O1|Outcome|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period
754985|NCT00048048|O9|Outcome|Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754986|NCT00048048|O8|Outcome|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754987|NCT00048048|O7|Outcome|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754988|NCT00048048|O6|Outcome|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754989|NCT00048048|O5|Outcome|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754990|NCT00048048|O4|Outcome|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period
754991|NCT00048048|O3|Outcome|Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754992|NCT00048048|O2|Outcome|Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754993|NCT00048048|O1|Outcome|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754994|NCT00048048|O9|Outcome|Cohort 9 (RO0503821, 1.8 mcg/kg 1x/3 Week)|Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754995|NCT00048048|O8|Outcome|Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)|Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754996|NCT00048048|O7|Outcome|Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)|Eligible participants in received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754997|NCT00048048|O6|Outcome|Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)|Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
754998|NCT00048048|O5|Outcome|Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755139|NCT00046475|E5|Reported Event|Follow-up|Patients were contacted 30 days after last study drug dose to follow up on any ongoing AEs and inquire if there were any new AEs.
754999|NCT00048048|O4|Outcome|Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)|Eligible participants in received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755000|NCT00048048|O3|Outcome|Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755001|NCT00048048|O2|Outcome|Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)|Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755002|NCT00048048|O1|Outcome|Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)|Eligible participants in received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755003|NCT00048048|E3|Reported Event|RO0503821 (1x/3week)|Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755004|NCT00048048|E2|Reported Event|RO0503821 (1x/2Week)|Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755005|NCT00048048|E1|Reported Event|RO0503821 (1x/Week)|Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period.
755006|NCT00048035|B7|Baseline|Total|Total of all reporting groups
755007|NCT00048035|B6|Baseline|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755008|NCT00048035|B5|Baseline|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755009|NCT00048035|B4|Baseline|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755010|NCT00048035|B3|Baseline|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755011|NCT00048035|B2|Baseline|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755012|NCT00048035|B1|Baseline|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755013|NCT00048035|P8|Participant Flow|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755014|NCT00048035|P7|Participant Flow|RO0503821 (1x/Week)|Eligible participants were administered intravenously (IV) RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) once weekly (1x/ week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755015|NCT00048035|P6|Participant Flow|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755140|NCT00046475|E4|Reported Event|Placebo|Patients received Placebo for 2 weeks.
755845|NCT00041717|B3|Baseline|Total|Total of all reporting groups
755016|NCT00048035|P5|Participant Flow|Cohort 5 (RO0503821 [0.6/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755017|NCT00048035|P4|Participant Flow|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755018|NCT00048035|P3|Participant Flow|Cohort 3 (RO0503821 [0.4/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755019|NCT00048035|P2|Participant Flow|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755020|NCT00048035|P1|Participant Flow|Cohort 1 (RO0503821 [0.25/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755021|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755022|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755023|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755024|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755025|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755026|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755027|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755028|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755029|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755030|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755031|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755032|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755033|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755034|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755035|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755036|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755037|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755038|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755039|NCT00048035|O2|Outcome|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755040|NCT00048035|O1|Outcome|RO0503821 (1x/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755041|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755042|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755043|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755044|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755045|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755046|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755047|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755048|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755049|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755050|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755141|NCT00046475|E3|Reported Event|Midodrine HCl|Patients received their optimum dose of Midodrine HCl for 2 weeks.
755051|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755052|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755053|NCT00048035|E2|Reported Event|RO0503821 (1/2week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755054|NCT00048035|E1|Reported Event|RO0503821 (1/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
755055|NCT00047879|B3|Baseline|Total|Total of all reporting groups
755056|NCT00047879|B2|Baseline|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
755057|NCT00047879|B1|Baseline|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
755058|NCT00047879|P2|Participant Flow|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
755059|NCT00047879|P1|Participant Flow|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
755060|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
755061|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
755062|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
755063|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
755064|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
755065|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
755066|NCT00047879|E2|Reported Event|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
755067|NCT00047879|E1|Reported Event|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
755068|NCT00047697|B3|Baseline|Total|Total of all reporting groups
755069|NCT00047697|B2|Baseline|Placebo|Participants will start with 5 mg/day of placebo, then have their doses increased to 10 mg/day of placebo after 4 weeks.
755070|NCT00047697|B1|Baseline|Donepezil HCL|Donepezil HCl: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
755071|NCT00047697|P2|Participant Flow|Placebo|Subjects placed on 5 mg or 10 mg of placebo
755072|NCT00047697|P1|Participant Flow|Donepezil HCL|Subjects placed on 5 and 10 mg of donepezil
755073|NCT00047697|O2|Outcome|Placebo|Placebo used in place of Donepezil HCL
755074|NCT00047697|O1|Outcome|Donepezil HCl|Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
755075|NCT00047697|O2|Outcome|Placebo|Placebo used in place of Donepezil HCL
755076|NCT00047697|O1|Outcome|Donepezil HCl|Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
755077|NCT00047697|O2|Outcome|Placebo|Placebo used in placed of Donepezil HCL
755078|NCT00047697|O1|Outcome|Donepezil HCl|Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
755079|NCT00047697|E2|Reported Event|Placebo|Placebo substituted for Donepezil HCL
755080|NCT00047697|E1|Reported Event|Donepezil HCL|5 mg of donepezil for 4 weeks, followed by 10 mg of donepezil for 6 weeks.
755081|NCT00047619|B3|Baseline|Total|Total of all reporting groups
755082|NCT00047619|B2|Baseline|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage not directed at wound or patient"
755083|NCT00047619|B1|Baseline|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
755084|NCT00047619|P2|Participant Flow|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
755085|NCT00047619|P1|Participant Flow|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
755086|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
755093|NCT00047463|B2|Baseline|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
755094|NCT00047463|B1|Baseline|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
755095|NCT00047463|P2|Participant Flow|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
755096|NCT00047463|P1|Participant Flow|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
755097|NCT00047463|O1|Outcome|All Participants Prior to Randomization|
755098|NCT00047463|O2|Outcome|Placebo-CPAP|Placebo-CPAP: Placebo-CPAP
755099|NCT00047463|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|continuous positive airway pressure (CPAP): a mask treatment for sleep apnea
755100|NCT00047463|O2|Outcome|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
755101|NCT00047463|O1|Outcome|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
755102|NCT00047463|E2|Reported Event|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
755103|NCT00047463|E1|Reported Event|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
755104|NCT00046475|B3|Baseline|Total|Total of all reporting groups
755105|NCT00046475|B2|Baseline|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
755106|NCT00046475|B1|Baseline|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
755107|NCT00046475|P3|Participant Flow|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
755108|NCT00046475|P2|Participant Flow|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
755109|NCT00046475|P1|Participant Flow|All Enrolled Participants|All patients who were enrolled in this study are included in this population.
755110|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755111|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755112|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755113|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755114|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
755115|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
755116|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
755117|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755118|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755119|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755120|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755121|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755122|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755123|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755124|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755125|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755126|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755127|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755128|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755129|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755130|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755131|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755132|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755133|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755134|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755135|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755136|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
755137|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
755143|NCT00046475|E1|Reported Event|Screening/Washout|Patients signed the informed consent form and were screened for eligibility. Eligible patients were off drug for 1 week.
755144|NCT00046566|B4|Baseline|Total|Total of all reporting groups
755145|NCT00046566|B3|Baseline|Carbohydrate-soy Protein-milk Protein|Carbohydrate-soy protein-milk protein group
755146|NCT00046566|B2|Baseline|Milk Protein-carbohydrate-soy Protein|Milk protein-carbohydrate-soy protein group
755147|NCT00046566|B1|Baseline|Soy Protein-milk-protein-carbohydrate|Soy protein-milk-protein-carbohydrate group
755148|NCT00046566|P3|Participant Flow|Carbohydrate-soy Protein-milk Protein Group|118 participants assigned to carbohydrate-soy protein-milk protein group. They received 40 g/d carbohydrate for 8 weeks, then 40 g/d soy protein for 8 weeks, and finally 40 g/d milk protein for 8 weeks.
755149|NCT00046566|P2|Participant Flow|Milk Protein-carbohydrate-soy Protein Group|117 participants assigned to milk protein-carbohydrate-soy protein group. They received 40 g/d milk protein for 8 weeks, then 40 g/d carbohydrate for 8 weeks, and finally 40 g/d soy protein for 8 weeks.
755150|NCT00046566|P1|Participant Flow|Soy Protein-milk Protein-carbohydrate Group|117 participants assigned to soy protein-milk protein-carbohydrate group. They received 40 g/d soy protein for 8 weeks, then 40 g/d milk protein for 8 weeks, and finally 40 g/d carbohydrate for 8 weeks.
755151|NCT00046566|O3|Outcome|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
755152|NCT00046566|O2|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
755153|NCT00046566|O1|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
755154|NCT00046566|O3|Outcome|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
755155|NCT00046566|O2|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
755156|NCT00046566|O1|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
755157|NCT00046566|O3|Outcome|Carbohydrate Supplementation|Cross-over analysis of milk protein supplementation
755158|NCT00046566|O2|Outcome|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
755159|NCT00046566|O1|Outcome|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
755160|NCT00046566|E3|Reported Event|Carbohydrate Supplementation|Cross-over analysis carbohydrate supplementation
755161|NCT00046566|E2|Reported Event|Milk Protein Supplementation|Cross-over analysis of milk protein supplementation
755162|NCT00046566|E1|Reported Event|Soy Protein Supplementation|Cross-over analysis of soy protein supplementation
755163|NCT00046228|B4|Baseline|Total|Total of all reporting groups
755164|NCT00046228|B3|Baseline|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755165|NCT00046228|B2|Baseline|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755166|NCT00046228|B1|Baseline|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755167|NCT00046228|P3|Participant Flow|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755168|NCT00046228|P2|Participant Flow|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755169|NCT00046228|P1|Participant Flow|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755170|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755171|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755172|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755173|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755174|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755175|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755176|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755177|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755178|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755179|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755180|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755181|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755182|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755183|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755185|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755186|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755187|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755188|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755189|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755190|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755191|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755192|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755193|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755194|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755195|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755196|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755197|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755198|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755199|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755200|NCT00046228|E3|Reported Event|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
755201|NCT00046228|E2|Reported Event|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
755202|NCT00046228|E1|Reported Event|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
755203|NCT00045942|B10|Baseline|Total|Total of all reporting groups
755204|NCT00045942|B9|Baseline|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755205|NCT00045942|B8|Baseline|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755206|NCT00045942|B7|Baseline|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755207|NCT00045942|B6|Baseline|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755208|NCT00045942|B5|Baseline|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755209|NCT00045942|B4|Baseline|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755210|NCT00045942|B3|Baseline|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755211|NCT00045942|B2|Baseline|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755212|NCT00045942|B1|Baseline|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755213|NCT00045942|P9|Participant Flow|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755214|NCT00045942|P8|Participant Flow|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755215|NCT00045942|P7|Participant Flow|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755216|NCT00045942|P6|Participant Flow|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755217|NCT00045942|P5|Participant Flow|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755218|NCT00045942|P4|Participant Flow|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755219|NCT00045942|P3|Participant Flow|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755220|NCT00045942|P2|Participant Flow|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755221|NCT00045942|P1|Participant Flow|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755222|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755223|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755224|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755225|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755226|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755227|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755228|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755229|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755230|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755231|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755232|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755233|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755234|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 200 mg/Day|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755235|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 200 mg/Day|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755318|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
755236|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 200 mg/Day|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755237|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755238|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755239|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755240|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755241|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755242|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755243|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755244|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755245|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755246|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755247|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755248|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755249|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755250|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755251|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755252|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755253|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755254|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755255|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755256|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755257|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755258|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755259|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755260|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755261|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755262|NCT00045942|O1|Outcome|FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755319|NCT00044512|E1|Reported Event|Sorafenib 400 mg b.i.d.|"Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d.Other AE section includes SAEs"
755320|NCT00044213|B5|Baseline|Total|Total of all reporting groups
755263|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755264|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755265|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755266|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755267|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755268|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755269|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755270|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755271|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755272|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755273|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755274|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755275|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755276|NCT00045942|O1|Outcome|FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755277|NCT00045942|O4|Outcome|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755278|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755279|NCT00045942|O2|Outcome|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755362|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
755280|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755281|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755282|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755283|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755284|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755285|NCT00045942|O4|Outcome|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755286|NCT00045942|O3|Outcome|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755287|NCT00045942|O2|Outcome|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755288|NCT00045942|O1|Outcome|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755289|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755290|NCT00045942|O1|Outcome|PKC412 in FLT3 Mutated Participants (Core)|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755291|NCT00045942|E9|Reported Event|FLT3 Wild Type PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755292|NCT00045942|E8|Reported Event|FLT3 Wild Type PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755293|NCT00045942|E7|Reported Event|FLT3 Mutated PKC+Itraconazole (E2)|Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
755294|NCT00045942|E6|Reported Event|FLT3 Mutated PKC412 Dose Escalation (E2)|Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
755295|NCT00045942|E5|Reported Event|FLT3 Wild Type PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755296|NCT00045942|E4|Reported Event|FLT3 Wild Type PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755297|NCT00045942|E3|Reported Event|FLT3 Mutated PKC412 200 mg/Day (E1)|Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755298|NCT00045942|E2|Reported Event|FLT3 Mutated PKC412 100 mg/Day (E1)|Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755299|NCT00045942|E1|Reported Event|PKC412 Core|Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
755300|NCT00044655|B3|Baseline|Total|Total of all reporting groups
755301|NCT00044655|B2|Baseline|Switch|Participants will change medications from medication prescribed at study entry
755302|NCT00044655|B1|Baseline|Stay|Participants will continue taking medication prescribed at study entry
755303|NCT00044655|P2|Participant Flow|Switch|Participants will change medications from medication prescribed at study entry
755304|NCT00044655|P1|Participant Flow|Stay|Participants will continue taking medication prescribed at study entry
755305|NCT00044655|O2|Outcome|Switch|Participants will change medications from medication prescribed at study entry
755306|NCT00044655|O1|Outcome|Stay|Participants will continue taking medication prescribed at study entry
755307|NCT00044655|E2|Reported Event|Switch|Participants will change medications from medication prescribed at study entry
755308|NCT00044655|E1|Reported Event|Stay|Participants will continue taking medication prescribed at study entry
755309|NCT00044512|B1|Baseline|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
755310|NCT00044512|P1|Participant Flow|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
755311|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
755312|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
755321|NCT00044213|B4|Baseline|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
755322|NCT00044213|B3|Baseline|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
755323|NCT00044213|B2|Baseline|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
755324|NCT00044213|B1|Baseline|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
755325|NCT00044213|P4|Participant Flow|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
755326|NCT00044213|P3|Participant Flow|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
755327|NCT00044213|P2|Participant Flow|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
755328|NCT00044213|P1|Participant Flow|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
755329|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
755330|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
755331|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
755332|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
755333|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
755334|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
755335|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
755336|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
755337|NCT00044213|E4|Reported Event|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
755338|NCT00044213|E3|Reported Event|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
755339|NCT00044213|E2|Reported Event|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
755340|NCT00044213|E1|Reported Event|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
755341|NCT00044044|B6|Baseline|Total|Total of all reporting groups
755342|NCT00044044|B5|Baseline|Placebo|Oral Capsule matching treatment group taken oce a day
755343|NCT00044044|B4|Baseline|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
755344|NCT00044044|B3|Baseline|80 mg|Lurasidone 80 mg oral tablet taken once a day
755345|NCT00044044|B2|Baseline|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
755346|NCT00044044|B1|Baseline|20 mg|Lurasidone 20 mg oral tablet taken once a day
755347|NCT00044044|P5|Participant Flow|Placebo|Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.
755348|NCT00044044|P4|Participant Flow|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
755349|NCT00044044|P3|Participant Flow|80 mg|Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
755350|NCT00044044|P2|Participant Flow|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
755351|NCT00044044|P1|Participant Flow|20 mg|Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
755352|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
755353|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
755354|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
755355|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
755356|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
755357|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
755358|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
755359|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
755360|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
755361|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
755368|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
755369|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
755370|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
755371|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
755372|NCT00044044|E5|Reported Event|Placebo|Oral Capsule matching treatment group taken oce a day
755373|NCT00044044|E4|Reported Event|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
755374|NCT00044044|E3|Reported Event|80 mg|Lurasidone 80 mg oral tablet taken once a day
755375|NCT00044044|E2|Reported Event|40 mg|Lurasidone 40 mg oral tablet taken once a day
755376|NCT00044044|E1|Reported Event|20 mg|Lurasidone 20 mg oral tablet taken once a day
755377|NCT00044005|B4|Baseline|Total|Total of all reporting groups
755378|NCT00044005|B3|Baseline|Lurasidone 80mg|Lurasidone 80mg oral tablets
755379|NCT00044005|B2|Baseline|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
755380|NCT00044005|B1|Baseline|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
755381|NCT00044005|P3|Participant Flow|Lurasidone 80mg|Lurasidone 80mg oral tablets
755382|NCT00044005|P2|Participant Flow|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
755383|NCT00044005|P1|Participant Flow|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
755384|NCT00044005|O3|Outcome|Lurasidone 80mg|Lurasidone 80mg oral tablets
755385|NCT00044005|O2|Outcome|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
755386|NCT00044005|O1|Outcome|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
755387|NCT00044005|E3|Reported Event|Lurasidone 80mg|Lurasidone 80mg oral tablets
755388|NCT00044005|E2|Reported Event|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
755389|NCT00044005|E1|Reported Event|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
755390|NCT00043979|B3|Baseline|Total|Total of all reporting groups
755391|NCT00043979|B2|Baseline|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755392|NCT00043979|B1|Baseline|Arm 1-Sibling Donors|Donors (n=30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.
755393|NCT00043979|P3|Participant Flow|Recipients Tacrolimus /Sirolimus Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received tacrolimus & sirolimus for GVHD prophylaxis."
755394|NCT00043979|P2|Participant Flow|Recipients Cyclosporine GVHD Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received cyclosporine for GVHD prophylaxis."
755395|NCT00043979|P1|Participant Flow|Sibling Donors|Donors (n = 30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.In period 1 they donated cells.
755396|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755397|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755398|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755399|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755400|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755401|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755402|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755403|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755404|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755405|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755406|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755407|NCT00043979|O2|Outcome|Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis|
755408|NCT00043979|O1|Outcome|Recipients -Cyclosporine GVHD Prophylaxis|
755409|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755410|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755411|NCT00043979|E1|Reported Event|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
755412|NCT00043550|B4|Baseline|Total|Total of all reporting groups
755413|NCT00043550|B3|Baseline|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
755414|NCT00043550|B2|Baseline|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
755415|NCT00043550|B1|Baseline|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
755416|NCT00043550|P3|Participant Flow|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
755417|NCT00043550|P2|Participant Flow|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
755418|NCT00043550|P1|Participant Flow|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
755419|NCT00043550|O3|Outcome|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
755420|NCT00043550|O2|Outcome|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
755421|NCT00043550|O1|Outcome|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
755422|NCT00043550|E3|Reported Event|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
755423|NCT00043550|E2|Reported Event|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
755424|NCT00043550|E1|Reported Event|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
755425|NCT00043186|B10|Baseline|Total|Total of all reporting groups
755426|NCT00043186|B9|Baseline|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755427|NCT00043186|B8|Baseline|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755428|NCT00043186|B7|Baseline|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755429|NCT00043186|B6|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755430|NCT00043186|B5|Baseline|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755431|NCT00043186|B4|Baseline|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755432|NCT00043186|B3|Baseline|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755433|NCT00043186|B2|Baseline|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755434|NCT00043186|B1|Baseline|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755435|NCT00043186|P9|Participant Flow|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755436|NCT00043186|P8|Participant Flow|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755437|NCT00043186|P7|Participant Flow|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755438|NCT00043186|P6|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755439|NCT00043186|P5|Participant Flow|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755440|NCT00043186|P4|Participant Flow|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755441|NCT00043186|P3|Participant Flow|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755442|NCT00043186|P2|Participant Flow|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755443|NCT00043186|P1|Participant Flow|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755444|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755445|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755446|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755447|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755448|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755484|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755449|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755450|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755451|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755452|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755453|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755454|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755455|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755456|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755457|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755458|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755459|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755460|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755461|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755462|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755463|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755464|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755465|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755466|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755467|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755468|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755469|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755470|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755471|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755472|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755473|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755474|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755475|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755476|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755477|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755478|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755479|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755480|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755481|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755482|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755483|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755555|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755485|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755486|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755487|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755488|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755489|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755490|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755491|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755492|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755493|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755494|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755495|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755496|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755497|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755498|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755499|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755500|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755501|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755502|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755503|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755504|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755505|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755506|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755507|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755508|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755509|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755510|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755511|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755512|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755513|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755514|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755515|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755516|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755517|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755518|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755519|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755591|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755520|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755521|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755522|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755523|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755524|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755525|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755526|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755527|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755528|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755529|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755530|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755531|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755532|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755533|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755534|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755535|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755536|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755537|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755538|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755539|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755540|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755541|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755542|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755543|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755544|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755545|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755546|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755547|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755548|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755549|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755550|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755551|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755552|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755553|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755554|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755846|NCT00041717|B2|Baseline|Placebo|Placebo : Placebo
755556|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755557|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755558|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755559|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755560|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755561|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755562|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755563|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755564|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755565|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755566|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755567|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755568|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755569|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755570|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755571|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755572|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755573|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755574|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755575|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755576|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755577|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755578|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755579|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755580|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755581|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755582|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755583|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755584|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755585|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755586|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755587|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755588|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755589|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755590|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755592|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755593|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755594|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755595|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755596|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755597|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755598|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755599|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755600|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755601|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755602|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755603|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755604|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755605|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755606|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755607|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755608|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755609|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755610|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755611|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755612|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755613|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755614|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755615|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755616|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755617|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755618|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755619|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755620|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755621|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755622|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755623|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755624|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755625|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755626|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755627|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755628|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755629|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755630|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755631|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755632|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755633|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755634|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755635|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755636|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755637|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755638|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755639|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755640|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755641|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755642|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755643|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755644|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755645|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755646|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755647|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755648|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755649|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755650|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755651|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755652|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755653|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755654|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755655|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755656|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755657|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755658|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755659|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755660|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755661|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755829|NCT00041756|P1|Participant Flow|Placebo Tablet|Placebo tablet dosed BID
755662|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755663|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755664|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755665|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755666|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755667|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755668|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755669|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755670|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755671|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755672|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755673|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755674|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755675|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755676|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755677|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755678|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755679|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755680|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755681|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755682|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755683|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755684|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755685|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755686|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755687|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755688|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755689|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755690|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755691|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755692|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755693|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755694|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755695|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755696|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755830|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
755697|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755698|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755699|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755700|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755701|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755702|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755703|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755704|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755705|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755706|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755707|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755708|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755709|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755710|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755711|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755712|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755713|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755714|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755715|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755716|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755717|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755718|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755719|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755720|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755721|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755722|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755723|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755724|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755725|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755726|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755727|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755728|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755729|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755730|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755731|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755831|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
755832|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
755732|NCT00043186|O1|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755733|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755734|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755735|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755736|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755737|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755738|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755739|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755740|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755741|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755742|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755743|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755744|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755745|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755746|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755747|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755748|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755749|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755750|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755751|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755752|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755753|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755754|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755755|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755756|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755757|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755758|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755759|NCT00043186|E9|Reported Event|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
755760|NCT00043186|E8|Reported Event|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
755761|NCT00043186|E7|Reported Event|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755762|NCT00043186|E6|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
755763|NCT00043186|E5|Reported Event|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755764|NCT00043186|E4|Reported Event|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
755765|NCT00043186|E3|Reported Event|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755766|NCT00043186|E2|Reported Event|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
755833|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
755767|NCT00043186|E1|Reported Event|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
755768|NCT00042432|B3|Baseline|Total|Total of all reporting groups
755769|NCT00042432|B2|Baseline|Placebo|Placebo administered orally once daily
755770|NCT00042432|B1|Baseline|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
755771|NCT00042432|P2|Participant Flow|Placebo|Placebo administered orally once daily
755772|NCT00042432|P1|Participant Flow|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
755773|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
755774|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
755775|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
755776|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
755777|NCT00042432|E2|Reported Event|Cinacalcet|
755778|NCT00042432|E1|Reported Event|Placebo|
755779|NCT00042224|B3|Baseline|Total|Total of all reporting groups
755780|NCT00042224|B2|Baseline|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
755781|NCT00042224|B1|Baseline|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
755782|NCT00042224|P2|Participant Flow|2 Medication Monotherapy|Clozapine: Patients with psychotic symptoms will receive clozapine
755783|NCT00042224|P1|Participant Flow|1 Electroconvulsive Therapy With Medication|"Electroconvulsive Therapy (ECT): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Clozapine: Patients with psychotic symptoms will receive clozapine"
755784|NCT00042224|O2|Outcome|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
755785|NCT00042224|O1|Outcome|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
755786|NCT00042224|E2|Reported Event|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
755787|NCT00042224|E1|Reported Event|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
755788|NCT00041938|B3|Baseline|Total|Total of all reporting groups
755789|NCT00041938|B2|Baseline|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755790|NCT00041938|B1|Baseline|Aspirin|Aspirin : 325 mg per day
755791|NCT00041938|P2|Participant Flow|Warfarin|Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
755792|NCT00041938|P1|Participant Flow|Aspirin|Aspirin : 325 mg per day
755793|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755794|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755795|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755796|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755797|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755798|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755799|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755800|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755801|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755802|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755803|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755804|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755805|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755806|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755807|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755808|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755809|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755810|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755811|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755812|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755813|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755814|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755815|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755816|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
755817|NCT00041938|E2|Reported Event|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
755818|NCT00041938|E1|Reported Event|Aspirin|Aspirin : 325 mg per day
755819|NCT00041756|B6|Baseline|Total|Total of all reporting groups
755820|NCT00041756|B5|Baseline|200 mg PG-530742|200 mg PG-530742 dosed BID
755821|NCT00041756|B4|Baseline|100 mg PG-530742|100 mg PG-530742 dosed BID
755822|NCT00041756|B3|Baseline|50 mg PG-530742|50 mg PG-530742 dosed BID
755823|NCT00041756|B2|Baseline|25 mg PG-530742|25 mg PG-530742 dosed BID
755824|NCT00041756|B1|Baseline|Placebo Tablet|Placebo tablet dosed BID
755825|NCT00041756|P5|Participant Flow|200 mg PG-530742|200 mg PG-530742 dosed BID
755826|NCT00041756|P4|Participant Flow|100 mg PG-530742|100 mg PG-530742 dosed BID
755827|NCT00041756|P3|Participant Flow|50 mg PG-530742|50 mg PG-530742 dosed BID
755828|NCT00041756|P2|Participant Flow|25 mg PG-530742|25 mg PG-530742 dosed BID
755847|NCT00041717|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
755848|NCT00041717|P2|Participant Flow|Placebo|Placebo : Placebo
755849|NCT00041717|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-sustained release (SR) : 25mg bid (twice daily)
755850|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
755851|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
755852|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
755853|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
755854|NCT00041717|E2|Reported Event|Placebo|Placebo : Placebo
755855|NCT00041717|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
755856|NCT00041470|B1|Baseline|Phase I/II|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel is administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
755857|NCT00041470|P1|Participant Flow|Paclitaxel, Vinorelbine, G-CSF, Herceptin - no Placebo|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel is administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until progression"
755858|NCT00041470|O1|Outcome|Weekly Paclitaxel, Vinorelbine and GCSF|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease.~Paclitaxel weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Herceptin: 4 mg/kg IV loading dose day 1"
755859|NCT00041470|O1|Outcome|Weekly Paclitaxel, Vinorelbine and GCSF|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease.~Paclitaxel weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Herceptin: 4 mg/kg IV loading dose day 1"
755860|NCT00041470|E1|Reported Event|Weekly Paclitaxel and Vinorelbine With GCSF Support|"Weekly paclitaxel (50 mg/m2 IV) and vinorelbine (20 mg/m2 IV) with daily G-CSF and Herceptin for patients with HER-2+ disease. Treatment until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and meet the cardiac safety criteria will receive weekly Herceptin administered by infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
755861|NCT00040664|B1|Baseline|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
755862|NCT00040664|P4|Participant Flow|12-18 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 12-18 years
755863|NCT00040664|P3|Participant Flow|6-11 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 6-11 years
755864|NCT00040664|P2|Participant Flow|2-5 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 2-5 years
755865|NCT00040664|P1|Participant Flow|Overall Fosamprenavir (FPV)/Ritonavir(RTV)|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
755866|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
755867|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
755868|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
755869|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
755870|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
755871|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
755872|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
755873|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
755874|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
755875|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
755876|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
755877|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
755878|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
755879|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
755880|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
755881|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
755882|NCT00040664|O1|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
755883|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
755884|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
755885|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
755886|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
755887|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
755888|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
755889|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
755890|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
755891|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
755892|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
755893|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
755894|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
755895|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
755896|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
755897|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
755898|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
755899|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
755900|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
755901|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
755902|NCT00040664|O2|Outcome|FPV Oral Suspension|Fosamprenavir 50 mg/mL oral suspension/ritonavir 80 mg/mL oral solution once daily
755903|NCT00040664|O1|Outcome|FPV Tablet|Fosamprenavir 700 mg tablets/ritonavir 100 mg capsules once daily
755904|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
755905|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
755906|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
755907|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
755908|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
755909|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
755910|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
755911|NCT00040664|E1|Reported Event|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
755912|NCT00041392|B3|Baseline|Total|Total of all reporting groups
755913|NCT00041392|B2|Baseline|0.9 % Saline|100 mg/kg 0.9 % saline
755914|NCT00041392|B1|Baseline|Magnesium|100 mg/kg magnesium
755915|NCT00041392|P2|Participant Flow|0.9 % Saline|100 mg/kg 0.9 % saline
755916|NCT00041392|P1|Participant Flow|Magnesium|100 mg/kg magnesium
755917|NCT00041392|O2|Outcome|0.9 % Saline|100 mg/kg 0.9 % saline
755918|NCT00041392|O1|Outcome|Magnesium|100 mg/kg magnesium
755919|NCT00041392|E2|Reported Event|0.9 % Saline|100 mg/kg 0.9 % saline
755920|NCT00041392|E1|Reported Event|Magnesium|100 mg/kg magnesium
755921|NCT00040365|B1|Baseline|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755922|NCT00040365|P1|Participant Flow|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755923|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755924|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755925|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755926|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755927|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755928|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755929|NCT00040365|E1|Reported Event|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
755930|NCT00039871|B1|Baseline|PegIntron Plus Rebetol|
755931|NCT00039871|P1|Participant Flow|PegIntron Plus Rebetol|
755932|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
755933|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
755934|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
755935|NCT00039871|E1|Reported Event|PegIntron Plus Rebetol|
755936|NCT00039741|B5|Baseline|Total|Total of all reporting groups
755937|NCT00039741|B4|Baseline|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
755938|NCT00039741|B3|Baseline|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
755939|NCT00039741|B2|Baseline|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
755940|NCT00039741|B1|Baseline|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
755941|NCT00039741|P4|Participant Flow|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
755942|NCT00039741|P3|Participant Flow|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
755943|NCT00039741|P2|Participant Flow|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
755944|NCT00039741|P1|Participant Flow|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
755945|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755946|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755947|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755948|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755949|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755950|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755951|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755952|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755953|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755954|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755955|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755956|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755957|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755958|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755959|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755960|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755961|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755962|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755963|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755964|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755965|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755966|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755967|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755968|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755969|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755970|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755971|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755972|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755973|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755974|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755975|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755976|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755977|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
755978|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
755979|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
755980|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
755981|NCT00039741|E4|Reported Event|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
755982|NCT00039741|E3|Reported Event|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
755983|NCT00039741|E2|Reported Event|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
755984|NCT00039741|E1|Reported Event|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
755985|NCT00038948|B3|Baseline|Total|Total of all reporting groups
755986|NCT00038948|B2|Baseline|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
755987|NCT00038948|B1|Baseline|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
755988|NCT00038948|P2|Participant Flow|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
755989|NCT00038948|P1|Participant Flow|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
755990|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor therapy
755991|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
755992|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor therapy
755993|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
755994|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
755995|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.
755996|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
755997|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
755998|NCT00038948|E2|Reported Event|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
755999|NCT00038948|E1|Reported Event|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
756000|NCT00038857|B1|Baseline|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
756001|NCT00038857|P1|Participant Flow|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
756002|NCT00038857|O1|Outcome|Melphalan + Thiotepa + Fludarabine + Rabbit ATG + CD34 PBPC|Melphalan 140 mg/m^2 given for one day. Thiotepa 10 mg/kg given for one day. Fludarabine 40 mg/m^2 given daily for four days. Rabbit ATG 1.5 mg/kg given daily for four days. Infusion of CD34+ Selected Cells given on Day 0.
756003|NCT00038857|E1|Reported Event|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
756004|NCT00038727|B4|Baseline|Total|Total of all reporting groups
756005|NCT00038727|B3|Baseline|3 Original Placebo|"randomized to masked placebo during DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
756006|NCT00038727|B2|Baseline|2 Original Metformin|"randomized to the masked metformin treatment group during DPP and continued open label in DPPOS. Participants were also offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle in DPPOS Phase 1 and 2.~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day, masked in DPP and open label in DPPOS~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
756007|NCT00038727|B1|Baseline|1 Original Lifestyle|"randomized to unmasked Intensive Lifestyle during the DPP and offered Intensive Lifestyle Group Session, DPPOS Group Lifestyle plus DPPOS Boost Lifestyle sessions in DPPOS Phase 1 and 2~DPPOS Group Lifestyle: Quarterly group lifestyle sessions~DPPOS Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.~Intensive Lifestyle Group Session: 16 session curriculum in group format. In DPP delivered to ILS as individual sessions"
756008|NCT00038727|P3|Participant Flow|3 Original Placebo|"Group Lifestyle, previously placebo treated participants during DPP~Group Lifestyle: Quarterly group lifestyle sessions"
756009|NCT00038727|P2|Participant Flow|2 Original Metformin|"Metformin / Lifestyle, previously the metformin treatment group during DPP~Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day"
756010|NCT00038727|P1|Participant Flow|1 Original Lifestyle|"Boost / Lifestyle, previously Intensive Lifestyle during the DPP~Group Lifestyle: Quarterly group lifestyle sessions~Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up."
756011|NCT00038727|O3|Outcome|3 Original Placebo|"Group Lifestyle, previously placebo treated participants during DPP~Group Lifestyle: Quarterly group lifestyle sessions"
756012|NCT00038727|O2|Outcome|2 Original Metformin|"Metformin / Lifestyle, previously the metformin treatment group during DPP~Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day"
756013|NCT00038727|O1|Outcome|1 Original Lifestyle|"Boost / Lifestyle, previously Intensive Lifestyle during the DPP~Group Lifestyle: Quarterly group lifestyle sessions~Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up."
756014|NCT00038727|O3|Outcome|3 Original Placebo|"Group Lifestyle, previously placebo treated participants during DPP~Group Lifestyle: Quarterly group lifestyle sessions"
756015|NCT00038727|O2|Outcome|2 Original Metformin|"Metformin / Lifestyle, previously the metformin treatment group during DPP~Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day"
756016|NCT00038727|O1|Outcome|1 Original Lifestyle|"Boost / Lifestyle, previously Intensive Lifestyle during the DPP~Group Lifestyle: Quarterly group lifestyle sessions~Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up."
756017|NCT00038727|E3|Reported Event|3 Original Placebo|"Group Lifestyle, previously placebo treated participants during DPP~Group Lifestyle: Quarterly group lifestyle sessions"
756018|NCT00038727|E2|Reported Event|2 Original Metformin|"Metformin / Lifestyle, previously the metformin treatment group during DPP~Group Lifestyle: Quarterly group lifestyle sessions~Metformin: Administered as 850mg twice per day"
756019|NCT00038727|E1|Reported Event|1 Original Lifestyle|"Boost / Lifestyle, previously Intensive Lifestyle during the DPP~Group Lifestyle: Quarterly group lifestyle sessions~Boost Lifestyle: In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up."
756020|NCT00038610|B1|Baseline|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
756021|NCT00038610|P1|Participant Flow|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
756022|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
756023|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
756024|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
756025|NCT00038610|E1|Reported Event|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
756026|NCT00038467|B3|Baseline|Total|Total of all reporting groups
756027|NCT00038467|B2|Baseline|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756028|NCT00038467|B1|Baseline|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756029|NCT00038467|P2|Participant Flow|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756030|NCT00038467|P1|Participant Flow|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756031|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756032|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756033|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756034|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756035|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756036|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756037|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756038|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756039|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756114|NCT00037830|B2|Baseline|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
756040|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756041|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756042|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756043|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756044|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756045|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756046|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756047|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756048|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756049|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756050|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756051|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756052|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756053|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756054|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756055|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756056|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756057|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756058|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756059|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756115|NCT00037830|B1|Baseline|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
756060|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756061|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756062|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756063|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756064|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756065|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756066|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756067|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756068|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756069|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756070|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756071|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756072|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756073|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756074|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756075|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756076|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756077|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756078|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756079|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756153|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
756538|NCT00029146|B2|Baseline|Non-surgical Group|Receives best current practice medical therapy
756080|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756081|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756082|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756083|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756084|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756085|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756086|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756087|NCT00038467|E2|Reported Event|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
756088|NCT00038467|E1|Reported Event|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
756089|NCT00038103|B3|Baseline|Total|Total of all reporting groups
756090|NCT00038103|B2|Baseline|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756091|NCT00038103|B1|Baseline|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756092|NCT00038103|P2|Participant Flow|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756093|NCT00038103|P1|Participant Flow|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756094|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756095|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756096|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756097|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756098|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756099|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756100|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756101|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756102|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756103|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756104|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756105|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756106|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756107|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756108|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756109|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756110|NCT00038103|E2|Reported Event|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
756111|NCT00038103|E1|Reported Event|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
756112|NCT00037830|B4|Baseline|Total|Total of all reporting groups
756113|NCT00037830|B3|Baseline|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
756116|NCT00037830|P3|Participant Flow|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
756117|NCT00037830|P2|Participant Flow|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
756118|NCT00037830|P1|Participant Flow|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
756119|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
756120|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
756121|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
756122|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
756123|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
756124|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
756125|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
756126|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
756127|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
756128|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
756129|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
756130|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
756131|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
756132|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
756133|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
756134|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
756135|NCT00037830|E3|Reported Event|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
756136|NCT00037830|E2|Reported Event|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
756137|NCT00037830|E1|Reported Event|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
756138|NCT00036569|B1|Baseline|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756139|NCT00036569|P1|Participant Flow|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756140|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756141|NCT00036569|O2|Outcome|QOL Score at Follow-up|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756142|NCT00036569|O1|Outcome|QOL Score at Baseline|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756143|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756144|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756145|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756146|NCT00036569|E1|Reported Event|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
756147|NCT00036270|B3|Baseline|Total|Total of all reporting groups
756148|NCT00036270|B2|Baseline|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756149|NCT00036270|B1|Baseline|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
756150|NCT00036270|P2|Participant Flow|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756151|NCT00036270|P1|Participant Flow|Exemestane|Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.
756152|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756154|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756155|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
756156|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756157|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
756158|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756159|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
756160|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756161|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
756162|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756163|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
756164|NCT00036270|E2|Reported Event|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years
756165|NCT00036270|E1|Reported Event|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
756166|NCT00035932|B4|Baseline|Total|Total of all reporting groups
756167|NCT00035932|B3|Baseline|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756168|NCT00035932|B2|Baseline|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756169|NCT00035932|B1|Baseline|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756170|NCT00035932|P3|Participant Flow|LPV / RTV|"lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756171|NCT00035932|P2|Participant Flow|ATV 400 mg / SQV|"ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756172|NCT00035932|P1|Participant Flow|ATV 300 mg / RTV|"atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756173|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756174|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756175|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756176|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756177|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756178|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756179|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756180|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756181|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756182|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756183|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756184|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756185|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756186|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756422|NCT00031486|P2|Participant Flow|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756187|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756188|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756189|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756190|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756191|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756192|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756193|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756194|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756195|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756196|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756197|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756198|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756199|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756200|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756201|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756202|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756203|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756204|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756205|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756206|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756207|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756208|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756209|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756210|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756211|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756212|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756213|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756214|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756215|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756216|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756217|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756218|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756219|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756220|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756221|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756222|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756223|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756224|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756225|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756226|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756227|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756228|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756229|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
756230|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
756231|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
756232|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
756233|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
756234|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
756235|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
756236|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
756237|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756238|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756239|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756240|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756241|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756242|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756243|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756244|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756245|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756246|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756247|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756423|NCT00031486|P1|Participant Flow|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
756248|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756249|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756250|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756251|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756252|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756253|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756254|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756255|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756256|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756257|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756258|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756259|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756260|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756261|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756262|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756263|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756264|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756265|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756266|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756267|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756268|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756269|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756270|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756271|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756272|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756273|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756274|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756275|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756276|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756277|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756424|NCT00031486|O3|Outcome|Total|
756278|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756279|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756280|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756281|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756282|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756283|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756284|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756285|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756286|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756287|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756288|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756289|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756290|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756291|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
756292|NCT00035932|E3|Reported Event|LPV/RTV|lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
756293|NCT00035932|E2|Reported Event|ATV400/SQV|ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
756294|NCT00035932|E1|Reported Event|ATV300/RTV|atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
756295|NCT00035815|B3|Baseline|Total|Total of all reporting groups
756296|NCT00035815|B2|Baseline|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
756297|NCT00035815|B1|Baseline|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
756298|NCT00035815|P2|Participant Flow|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
756299|NCT00035815|P1|Participant Flow|IGF-1|The insulin-like growth factor type 1 (IGF-1) arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
756300|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
756301|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
756302|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
756303|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
756304|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
756305|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
756306|NCT00035815|E2|Reported Event|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
756307|NCT00035815|E1|Reported Event|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
756308|NCT00035555|B4|Baseline|Total|Total of all reporting groups
756309|NCT00035555|B3|Baseline|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756310|NCT00035555|B2|Baseline|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756311|NCT00035555|B1|Baseline|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756312|NCT00035555|P3|Participant Flow|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756313|NCT00035555|P2|Participant Flow|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756314|NCT00035555|P1|Participant Flow|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756315|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756316|NCT00035555|O2|Outcome|Belatacept:Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756317|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756382|NCT00032591|P1|Participant Flow|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756383|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756384|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756318|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756319|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756320|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756321|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756322|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756323|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756324|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756325|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756385|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756386|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756387|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756326|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756327|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756328|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756329|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756330|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756331|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756332|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756333|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756388|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756389|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756390|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756334|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756335|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756336|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756337|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756338|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756339|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756340|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756341|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756391|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756392|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756393|NCT00032591|E2|Reported Event|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756342|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756343|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756344|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756345|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756346|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756347|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756348|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756349|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756394|NCT00032591|E1|Reported Event|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756395|NCT00032487|B3|Baseline|Total|Total of all reporting groups
756396|NCT00032487|B2|Baseline|Arm 2/Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
756350|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756351|NCT00035555|E3|Reported Event|Cyclosporin Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756352|NCT00035555|E2|Reported Event|Belatacept: More-intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756353|NCT00035555|E1|Reported Event|Belatacept: Less-intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
756354|NCT00033917|B3|Baseline|Total|Total of all reporting groups
756355|NCT00033917|B2|Baseline|Placebo|Group randomized to an equal volume of placebo
756356|NCT00033917|B1|Baseline|Indomethacin|subjects randomized to early low dose indomethacin
756357|NCT00033917|P2|Participant Flow|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
756358|NCT00033917|P1|Participant Flow|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
756359|NCT00033917|O4|Outcome|Placebo - IVH|Randomized to placebo; had IVH
756360|NCT00033917|O3|Outcome|Placebo - no IVH|Randomized to placebo - no IVH
756361|NCT00033917|O2|Outcome|Indomethacin - IVH|Randomized to indomethacin; had IVH
756362|NCT00033917|O1|Outcome|Indomethacin - no IVH|Subjects randomized to indomethacin and had no IVH
756363|NCT00033917|O2|Outcome|Placebo|Group randomized to an equal volume of placebo
756364|NCT00033917|O1|Outcome|Indomethacin|subjects randomized to early low dose indomethacin
756365|NCT00033917|E2|Reported Event|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
756366|NCT00033917|E1|Reported Event|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
756367|NCT00032630|B3|Baseline|Total|Total of all reporting groups
756368|NCT00032630|B2|Baseline|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
756369|NCT00032630|B1|Baseline|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
756370|NCT00032630|P2|Participant Flow|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
756371|NCT00032630|P1|Participant Flow|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
756372|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
756373|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
756374|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
756375|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
756376|NCT00032630|E2|Reported Event|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
756377|NCT00032630|E1|Reported Event|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
756378|NCT00032591|B3|Baseline|Total|Total of all reporting groups
756379|NCT00032591|B2|Baseline|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756380|NCT00032591|B1|Baseline|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
756381|NCT00032591|P2|Participant Flow|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
756536|NCT00029172|E1|Reported Event|Case Management|
756397|NCT00032487|B1|Baseline|Arm 1/Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
756398|NCT00032487|P2|Participant Flow|Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
756399|NCT00032487|P1|Participant Flow|Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
756400|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
756401|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
756402|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
756403|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
756404|NCT00032487|E2|Reported Event|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
756405|NCT00032487|E1|Reported Event|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
756406|NCT00031551|B3|Baseline|Total|Total of all reporting groups
756407|NCT00031551|B2|Baseline|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
756408|NCT00031551|B1|Baseline|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
756409|NCT00031551|P2|Participant Flow|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
756410|NCT00031551|P1|Participant Flow|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
756411|NCT00031551|O1|Outcome|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
756412|NCT00031551|O2|Outcome|Pilot Study: Day 9 After CT Scores|
756413|NCT00031551|O1|Outcome|Pilot Study: Baseline Scores|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
756414|NCT00031551|O1|Outcome|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
756415|NCT00031551|O2|Outcome|Main Study: Placebo Mouthwash|"Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.~Placebo"
756416|NCT00031551|O1|Outcome|Main Study: Etanercept Mouthwash|"Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Etanercept"
756417|NCT00031551|E2|Reported Event|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
756418|NCT00031551|E1|Reported Event|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
756419|NCT00031486|B3|Baseline|Total|Total of all reporting groups
756420|NCT00031486|B2|Baseline|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756421|NCT00031486|B1|Baseline|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
756425|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756426|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
756427|NCT00031486|O3|Outcome|Total|
756428|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756429|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
756430|NCT00031486|O3|Outcome|Total|
756431|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756432|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
756433|NCT00031486|O3|Outcome|Total|
756434|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756435|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
756436|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756437|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
756438|NCT00031486|O3|Outcome|Total|
756439|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756440|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
756441|NCT00031486|O3|Outcome|Total|
756442|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756443|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
756444|NCT00031486|E2|Reported Event|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
756445|NCT00031486|E1|Reported Event|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
756446|NCT00031460|B3|Baseline|Total|Total of all reporting groups
756447|NCT00031460|B2|Baseline|Placebo|Identical volume as acyclovir.
756448|NCT00031460|B1|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756449|NCT00031460|P2|Participant Flow|Placebo|Identical volume as acyclovir.
756450|NCT00031460|P1|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756451|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
756452|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756453|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
756454|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756455|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
756456|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756457|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
756458|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756459|NCT00031460|E2|Reported Event|Placebo|Identical volume as acyclovir.
756460|NCT00031460|E1|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756461|NCT00031447|B3|Baseline|Total|Total of all reporting groups
756462|NCT00031447|B2|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756463|NCT00031447|B1|Baseline|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
756464|NCT00031447|P2|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756465|NCT00031447|P1|Participant Flow|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
756466|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756467|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
756468|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756469|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
756470|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756471|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
756472|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756473|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
756474|NCT00031447|E2|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
756475|NCT00031447|E1|Reported Event|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
756476|NCT00030992|B1|Baseline|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
756477|NCT00030992|P1|Participant Flow|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
756478|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
756479|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
756480|NCT00030992|E1|Reported Event|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
756481|NCT00030147|B5|Baseline|Total|Total of all reporting groups
756482|NCT00030147|B4|Baseline|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
756483|NCT00030147|B3|Baseline|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
756484|NCT00030147|B2|Baseline|Placebo|Placebo skin patch and placebo tablets for eight weeks
756485|NCT00030147|B1|Baseline|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
756486|NCT00030147|P4|Participant Flow|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
756487|NCT00030147|P3|Participant Flow|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
756488|NCT00030147|P2|Participant Flow|Placebo|Placebo skin patch and placebo tablets for eight weeks
756489|NCT00030147|P1|Participant Flow|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
756490|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
756491|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
756492|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
756493|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
756494|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
756495|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
756496|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
756497|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
756498|NCT00030147|E4|Reported Event|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
756499|NCT00030147|E3|Reported Event|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
756500|NCT00030147|E2|Reported Event|Placebo|Placebo skin patch and placebo tablets for eight weeks
756501|NCT00030147|E1|Reported Event|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
756502|NCT00029536|B5|Baseline|Total|Total of all reporting groups
756503|NCT00029536|B4|Baseline|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
756504|NCT00029536|B3|Baseline|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
756505|NCT00029536|B2|Baseline|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
756506|NCT00029536|B1|Baseline|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
756507|NCT00029536|P4|Participant Flow|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
756508|NCT00029536|P3|Participant Flow|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
756509|NCT00029536|P2|Participant Flow|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
756510|NCT00029536|P1|Participant Flow|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
756511|NCT00029536|O2|Outcome|Placebo Lozenges|Subjects with catamenial and non-Catamenial epilepsy who received matched placebo lozenges
756512|NCT00029536|O1|Outcome|Progesterone Lozenges|Subjects with catamenial and Non-Catamential epilepsy who received 200 mg progesterone lozenges
756513|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
756514|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
756515|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
756516|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
756517|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
756518|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
756519|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
756520|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
756521|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
756522|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
756523|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
756524|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
756525|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
756526|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
756527|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
756528|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
756529|NCT00029536|E4|Reported Event|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
756530|NCT00029536|E3|Reported Event|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
756531|NCT00029536|E2|Reported Event|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
756532|NCT00029536|E1|Reported Event|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
756533|NCT00029172|B1|Baseline|Case Management|
756534|NCT00029172|P1|Participant Flow|Case Management|
756535|NCT00029172|O1|Outcome|Case Management|
756539|NCT00029146|B1|Baseline|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756540|NCT00029146|P2|Participant Flow|Non-surgical Group|Receives best current practice medical therapy
756541|NCT00029146|P1|Participant Flow|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756542|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756543|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756544|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756545|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756546|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756547|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756548|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756549|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756550|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756551|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756552|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756553|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756554|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756555|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756556|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756557|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756558|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756559|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756560|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756561|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756562|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756563|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
756564|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756565|NCT00029146|E2|Reported Event|Non-surgical Group|Receives best current practice medical therapy
756566|NCT00029146|E1|Reported Event|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
756567|NCT00029107|B3|Baseline|Total|Total of all reporting groups
756568|NCT00029107|B2|Baseline|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
756569|NCT00029107|B1|Baseline|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
756570|NCT00029107|P2|Participant Flow|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
756571|NCT00029107|P1|Participant Flow|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
756572|NCT00029107|O2|Outcome|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
756573|NCT00029107|O1|Outcome|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
756574|NCT00029107|E2|Reported Event|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
756575|NCT00029107|E1|Reported Event|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
756576|NCT00028262|B1|Baseline|Drug Cystagon and N-acetylcysteine|
756577|NCT00028262|P1|Participant Flow|Drug Cystagon and N-acetylcysteine|
756578|NCT00028262|O1|Outcome|Drug Cystagon and N-acetylcysteine|
756579|NCT00028262|E1|Reported Event|Drug Cystagon and N-acetylcysteine|
756580|NCT00028093|B3|Baseline|Total|Total of all reporting groups
756581|NCT00028093|B2|Baseline|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
756582|NCT00028093|B1|Baseline|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
756583|NCT00028093|P2|Participant Flow|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
756584|NCT00028093|P1|Participant Flow|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
756585|NCT00028093|O2|Outcome|Peginterferon|
756586|NCT00028093|O1|Outcome|Peginterferon+Ribavirin|
756655|NCT00025883|B2|Baseline|Metreleptin With Patial Lipodystrophy|patients with partial lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
756587|NCT00028093|E2|Reported Event|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
756588|NCT00028093|E1|Reported Event|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
756589|NCT00027378|B3|Baseline|Total|Total of all reporting groups
756590|NCT00027378|B2|Baseline|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756591|NCT00027378|B1|Baseline|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756592|NCT00027378|P2|Participant Flow|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756593|NCT00027378|P1|Participant Flow|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756594|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756595|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756596|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756597|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756598|NCT00027378|E2|Reported Event|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756599|NCT00027378|E1|Reported Event|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
756600|NCT00027027|B6|Baseline|Total|Total of all reporting groups
756601|NCT00027027|B5|Baseline|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756602|NCT00027027|B4|Baseline|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756603|NCT00027027|B3|Baseline|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756604|NCT00027027|B2|Baseline|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756605|NCT00027027|B1|Baseline|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756606|NCT00027027|P5|Participant Flow|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756607|NCT00027027|P4|Participant Flow|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756608|NCT00027027|P3|Participant Flow|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756609|NCT00027027|P2|Participant Flow|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756610|NCT00027027|P1|Participant Flow|rhuMAb 2C4: 0.5 Milligrams Per Kilogram (mg/kg)|Recombinant Humanized Antibody to human epidermal growth factor receptor 2 (rhuMAb 2C4) 0.5 mg/kg was administered once every 3 weeks as an intravenous (IV) infusion until progressive disease (PD) or unacceptable toxicity occurred for up to a maximum of 1 year.
756611|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756612|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756613|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756614|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756615|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756616|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756617|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756618|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756619|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756620|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756621|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756622|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756623|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756624|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756625|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756626|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756627|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756628|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756629|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756630|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756631|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756632|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756633|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756634|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756635|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756636|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756637|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756638|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756639|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756640|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756641|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756642|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756643|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756644|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756645|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756646|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756647|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756648|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756649|NCT00027027|E5|Reported Event|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756650|NCT00027027|E4|Reported Event|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756651|NCT00027027|E3|Reported Event|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756652|NCT00027027|E2|Reported Event|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756653|NCT00027027|E1|Reported Event|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
756654|NCT00025883|B3|Baseline|Total|Total of all reporting groups
756656|NCT00025883|B1|Baseline|Metreleptin With Generalized Lipodystrophy|patients with generalized lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
756657|NCT00025883|P1|Participant Flow|Metreleptin|subcutaneous metreleptin injections in one to two daily doses ranging from 0.06 to 0.24 mg/kg/day.
756658|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
756659|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
756660|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
756661|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
756662|NCT00025883|E1|Reported Event|Metreleptin|subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
756663|NCT00023595|B6|Baseline|Total|Total of all reporting groups
756664|NCT00023595|B5|Baseline|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756665|NCT00023595|B4|Baseline|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756666|NCT00023595|B3|Baseline|H01+H02: Medication + CABG|This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
756667|NCT00023595|B2|Baseline|H01: Medication + CABG|50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756668|NCT00023595|B1|Baseline|H01: Medication|50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756669|NCT00023595|P5|Participant Flow|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756670|NCT00023595|P4|Participant Flow|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756671|NCT00023595|P3|Participant Flow|H01+H02: Medication + CABG|This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
756672|NCT00023595|P2|Participant Flow|H01: Medication + CABG|50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756673|NCT00023595|P1|Participant Flow|H01: Medication|50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756674|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|"CABG plus Medication and Surgical ventricular reconstruction (SVR)~CABG plus MED and SVR: H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone"
756675|NCT00023595|O1|Outcome|H02: Medication+CABG|"Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease~CABG surgery plus MED: CABG plus standard medication management for Coronary Artery Disease"
756676|NCT00023595|O2|Outcome|H01: Medication|"Medical therapy alone to treat Coronary Artery Disease~Active Medication Alone: Standard medication for coronary artery disease and heart failure management."
756677|NCT00023595|O1|Outcome|H01: Medication + CABG|"Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease~CABG surgery plus MED (medication): CABG plus standard medication management for Coronary Artery Disease"
756678|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756679|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756680|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756825|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756681|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756682|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756683|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756684|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756685|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756686|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756687|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756688|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756689|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756690|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756691|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756692|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756693|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756694|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756695|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756696|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756697|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756698|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756699|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756700|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756969|NCT00016718|O3|Outcome|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
756701|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756702|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756703|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756704|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756705|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756706|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756707|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756708|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756709|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756710|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756711|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756712|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756713|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756714|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756715|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756716|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756717|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756718|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756719|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756720|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756970|NCT00016718|O2|Outcome|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
756721|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756722|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756723|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756724|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756725|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756726|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756727|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756728|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756729|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756730|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756731|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756732|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756733|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756734|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756735|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756736|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756737|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756738|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756739|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756740|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756971|NCT00016718|O1|Outcome|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
756741|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756742|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756743|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756744|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756745|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756746|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756747|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756748|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756749|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756750|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756751|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756752|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756753|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756754|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756755|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756756|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756757|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756758|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756759|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756760|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756972|NCT00016718|E3|Reported Event|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
756761|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756762|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756763|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756764|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756765|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756766|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756767|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756768|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756769|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756770|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756771|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756772|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756773|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756774|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm
756775|NCT00023595|O1|Outcome|H02: Medication+CABG|50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
756776|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756777|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756778|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
756779|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
756780|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756781|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756973|NCT00016718|E2|Reported Event|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
756974|NCT00016718|E1|Reported Event|Age Group 1|90 days to 3 years of age, inclusive (FTC, EFV, ddI)
756782|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756783|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756784|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756785|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756786|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
756787|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
756788|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756789|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756790|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
756791|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
756792|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756793|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756794|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|
756795|NCT00023595|O1|Outcome|Total H02: Medication+CABG|
756796|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756797|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756798|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756799|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756800|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756801|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756802|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756803|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756804|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756805|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756999|NCT00006604|P10|Participant Flow|Group 4: ATV Capsule (620mg/m^2)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
756806|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756807|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756808|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756809|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756810|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756811|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756812|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756813|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756814|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756815|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756816|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756817|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756818|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756819|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756820|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756821|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756822|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756823|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756824|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
757000|NCT00006604|P9|Participant Flow|Group 4: ATV Capsule (520mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
756826|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756827|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756828|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756829|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756830|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756831|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756832|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756833|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756834|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756835|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756836|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756837|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756838|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756839|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756840|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756841|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756842|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756843|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756844|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
757001|NCT00006604|P8|Participant Flow|Group 4: ATV Capsule (310mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
756845|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756846|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756847|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756848|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756849|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756850|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756851|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756852|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756853|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756854|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756855|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756856|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756857|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756858|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756859|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756860|NCT00023595|O2|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756861|NCT00023595|O1|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756862|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756863|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
757002|NCT00006604|P7|Participant Flow|Group 3: ATV Capsule (520mg/m^2)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
756864|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756865|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756866|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756867|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756868|NCT00023595|O2|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756869|NCT00023595|O1|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756870|NCT00023595|O2|Outcome|Total H02: Medication+CABG|"H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756871|NCT00023595|O1|Outcome|H02: Medication+CABG+SVR|50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
756872|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756873|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756874|NCT00023595|O2|Outcome|Total H01: Medication + CABG|"H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.~The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm."
756875|NCT00023595|O1|Outcome|H01: Medication|H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
756876|NCT00023595|E5|Reported Event|H02: Medication+CABG+SVR|
756877|NCT00023595|E4|Reported Event|H02: Medication+CABG|
756878|NCT00023595|E3|Reported Event|H01 & H02: Medication+CABG|
756879|NCT00023595|E2|Reported Event|H01: Medication + CABG|
756880|NCT00023595|E1|Reported Event|H01: Medication|
756881|NCT00023452|B3|Baseline|Total|Total of all reporting groups
756882|NCT00023452|B2|Baseline|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756883|NCT00023452|B1|Baseline|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756884|NCT00023452|P2|Participant Flow|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral rifapentine (RPT) tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by Directly Observed Therapy (DOT), defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756885|NCT00023452|P1|Participant Flow|9INH|Participants who were high-risk tuberculin skin test (TST) reactors (household and other close contacts of active tuberculosis [TB] cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on chest x-ray [CXR], human immunodeficiency virus [HIV] infected participants) self-administered oral isoniazid (INH) tablets (aged greater than or equal to [≥12] years of age received 5 milligrams per kilogram [mg/kg] and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
757003|NCT00006604|P6|Participant Flow|Group 3: ATV Capsule (415mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
756886|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756887|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756888|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756889|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756890|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756891|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756892|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756893|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756894|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756895|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756896|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756897|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756898|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756899|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756900|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756901|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR], HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756902|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756903|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756904|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756905|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) daily for 9 months (240 to 270 total doses).
756906|NCT00023452|E2|Reported Event|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
756907|NCT00023452|E1|Reported Event|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
756908|NCT00023322|B1|Baseline|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
756909|NCT00023322|P1|Participant Flow|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
756910|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
756911|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
756912|NCT00023322|E1|Reported Event|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
756913|NCT00023309|B3|Baseline|Total|Total of all reporting groups
756914|NCT00023309|B2|Baseline|Adefovir|Patients to receive adefovir alone
756915|NCT00023309|B1|Baseline|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
756916|NCT00023309|P2|Participant Flow|Adefovir|Patients to receive adefovir alone (10 mg daily).
756917|NCT00023309|P1|Participant Flow|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir, with lamivudine of 100 mg daily and adefovir of 10 mg daily
756918|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
756919|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
756920|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
756921|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
756922|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
756923|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
756924|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
756925|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
756926|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
756927|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
756928|NCT00023309|E2|Reported Event|Adefovir|Patients to receive adefovir alone
756929|NCT00023309|E1|Reported Event|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
756930|NCT00022763|B3|Baseline|Total|Total of all reporting groups
756931|NCT00022763|B2|Baseline|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
757004|NCT00006604|P5|Participant Flow|Group 3: ATV Capsule (310mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs.
757155|NCT00021541|O2|Outcome|Phase B - Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.
756932|NCT00022763|B1|Baseline|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756933|NCT00022763|P2|Participant Flow|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756934|NCT00022763|P1|Participant Flow|Stratum A|Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756935|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756936|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756937|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756938|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756939|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756940|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756941|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756942|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756943|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756944|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
757203|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
757204|NCT00010803|E2|Reported Event|Placebo|Placebo twice daily
756945|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756946|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756947|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756948|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756949|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756950|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756951|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756952|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756953|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756954|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
756955|NCT00022763|E1|Reported Event|Enfuvirtide|Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).
756956|NCT00016718|B4|Baseline|Total|Total of all reporting groups
756957|NCT00016718|B3|Baseline|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
756958|NCT00016718|B2|Baseline|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
756959|NCT00016718|B1|Baseline|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
756960|NCT00016718|P3|Participant Flow|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
756961|NCT00016718|P2|Participant Flow|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
756962|NCT00016718|P1|Participant Flow|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
756963|NCT00016718|O3|Outcome|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
756964|NCT00016718|O2|Outcome|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
756965|NCT00016718|O1|Outcome|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
756966|NCT00016718|O3|Outcome|Age Group 3|13 years to 21 years of age, inclusive (FTC, EFV, ddI)
756967|NCT00016718|O2|Outcome|Age Group 2|3 years to 12 years of age, inclusive (FTC, EFV, ddI)
756968|NCT00016718|O1|Outcome|Age Group 1|90 days to < 3 years of age, inclusive (FTC, EFV, ddI)
756975|NCT00014911|B1|Baseline|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756976|NCT00014911|P1|Participant Flow|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756977|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756978|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756979|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756980|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756981|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
757005|NCT00006604|P4|Participant Flow|Group 2: ATV Powder (620mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
757006|NCT00006604|P3|Participant Flow|Group 2: ATV Powder (310mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
757007|NCT00006604|P2|Participant Flow|Group 1: ATV Dose: Powder (620mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
757205|NCT00010803|E1|Reported Event|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
756982|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756983|NCT00014911|E1|Reported Event|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
756984|NCT00006604|B8|Baseline|Total|Total of all reporting groups
756985|NCT00006604|B7|Baseline|Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
756986|NCT00006604|B6|Baseline|Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
756987|NCT00006604|B5|Baseline|Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
756988|NCT00006604|B4|Baseline|Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
756989|NCT00006604|B3|Baseline|Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
756990|NCT00006604|B2|Baseline|Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
756991|NCT00006604|B1|Baseline|Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
756992|NCT00006604|P17|Participant Flow|Group 8: ATV Capsule (205mg/m^2) + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
756993|NCT00006604|P16|Participant Flow|Group 8: ATV Capsule (310mg/m^2) + RTV|Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
756994|NCT00006604|P15|Participant Flow|Group 7: ATV Capsule (205mg/m^2) + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
756995|NCT00006604|P14|Participant Flow|Group 7: ATV Capsule (310mg/m^2) + RTV|Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
756996|NCT00006604|P13|Participant Flow|Group 6: ATV Powder (310mg/m^2) + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
756997|NCT00006604|P12|Participant Flow|Group 5a: ATV Powder (310mg/m^2) + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
756998|NCT00006604|P11|Participant Flow|Group 5: ATV Powder (310mg/m^2) + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
757008|NCT00006604|P1|Participant Flow|Group 1: ATV Dose: Powder (310mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
757009|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757010|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757011|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757012|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757013|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757014|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757015|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757016|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757017|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757018|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757019|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757020|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757021|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757022|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757143|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757023|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757024|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757025|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757026|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757027|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757028|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757029|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757030|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757031|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 205mg/m^2"
757032|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757033|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757034|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757035|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757036|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757144|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757145|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757146|NCT00004978|E2|Reported Event|No rIL-2|Control group - no study-assigned medication
757037|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757038|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757039|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757040|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757041|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757042|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757043|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757044|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757045|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757046|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757047|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757048|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757049|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757050|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757147|NCT00004978|E1|Reported Event|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757148|NCT00021541|B3|Baseline|Total|Total of all reporting groups
757271|NCT00006489|B1|Baseline|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
757051|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757052|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757053|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m2"
757054|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757055|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757056|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757057|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757058|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757059|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757060|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757061|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757062|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
757063|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757064|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2 Capsule"
757149|NCT00021541|B2|Baseline|Phase B - Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I. These are the patients that started on placebo only. This number does not reflect the total amount of patients that crossed over to tipifarnib. Two of the 31 patients were deemed ineligible, thus 29 started placebo.
757065|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757066|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757067|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757068|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757069|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757070|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757071|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757072|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757073|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757074|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757075|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757076|NCT00006604|O3|Outcome|Step I: Group 5: ATV 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757077|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757078|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757150|NCT00021541|B1|Baseline|Phase A-Tipifarnib|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. These are the patients that started on tipifarnib only. This number does not reflect the total amount of patients that crossed over to placebo.
757079|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757080|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757081|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757082|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757083|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757084|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757085|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757086|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757087|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757088|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757089|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757090|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757091|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757092|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757151|NCT00021541|P2|Participant Flow|Phase B - Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.Patients receive placebo ONLY in the first treatment until they progress to the second treatment/crossover to receive tipifarnib.
757093|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757094|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 205mg/m^2"
757095|NCT00006604|O5|Outcome|Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757096|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757097|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757098|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757099|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757100|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757101|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757102|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757103|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757104|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757105|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757106|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757152|NCT00021541|P1|Participant Flow|Phase A -Tipifarnib|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Patients receive tipifarnib ONLY in the first treatment until they progress to the second treatment/crossover to receive placebo.
757107|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757108|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
757109|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757110|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
757111|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
757112|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
757113|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
757114|NCT00006604|E7|Reported Event|Group 5A: ATV 310mg/m^2 Powder + RTV|"91 to 180 days of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
757115|NCT00006604|E6|Reported Event|Group 8: ATV 205mg/m^2 Capsule + RTV|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
757116|NCT00006604|E5|Reported Event|Group 7: ATV 205mg/m^2 Capsule + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
757117|NCT00006604|E4|Reported Event|Group 6: ATV 310mg/m^2 Powder + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
757118|NCT00006604|E3|Reported Event|Group 5: ATV 310mg/m^2 Powder + RTV|"91 days to 2 years of age (less than or exactly 730 days.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
757119|NCT00006604|E2|Reported Event|Group 4: ATV 620mg/m^2 Capsule|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
757120|NCT00006604|E1|Reported Event|Group 3: ATV 520mg/m^2 Capsule|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
757121|NCT00004978|B3|Baseline|Total|Total of all reporting groups
757122|NCT00004978|B2|Baseline|No rIL-2|Control group - no study-assigned medication
757123|NCT00004978|B1|Baseline|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757124|NCT00004978|P2|Participant Flow|No rIL-2|Control group - no study-assigned medication
757125|NCT00004978|P1|Participant Flow|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757126|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757127|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757128|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757129|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757130|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757131|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757132|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757133|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757134|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757135|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757136|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757137|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757138|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757139|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757140|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757141|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
757142|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
757156|NCT00021541|O1|Outcome|Phase A - Tipifarnib|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
757157|NCT00021541|O1|Outcome|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
757158|NCT00021541|O2|Outcome|Phase B - Placebo|Placebo
757159|NCT00021541|O1|Outcome|Phase A - Tipifarnib|Tipifarnib
757160|NCT00021541|E1|Reported Event|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
757161|NCT00018031|B1|Baseline|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
757162|NCT00018031|P1|Participant Flow|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
757163|NCT00018031|O1|Outcome|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
757164|NCT00018031|E1|Reported Event|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
757165|NCT00015457|B1|Baseline|Cervical Dystonia|All participants enrolled in study
757166|NCT00015457|P2|Participant Flow|Placebo Then Amlodipine|Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
757167|NCT00015457|P1|Participant Flow|Amlodipine Then Placebo|Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.
757168|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
757169|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
757170|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
757171|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
757172|NCT00015457|E2|Reported Event|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
757173|NCT00015457|E1|Reported Event|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
757174|NCT00013611|B3|Baseline|Total|Total of all reporting groups
757175|NCT00013611|B2|Baseline|Antiretroviral Therapy Only|
757176|NCT00013611|B1|Baseline|Proleukin Plus Antiretroviral Therapy|
757177|NCT00013611|P2|Participant Flow|Antiretroviral Therapy Only|All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.
757178|NCT00013611|P1|Participant Flow|Proleukin Plus Antiretroviral Therapy|Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
757179|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
757180|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
757181|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
757182|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
757183|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
757184|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
757185|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
757186|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
757187|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
757188|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
757189|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
757190|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
757191|NCT00013611|E2|Reported Event|Antiretroviral Therapy Only|
757192|NCT00013611|E1|Reported Event|Proleukin Plus Antiretroviral Therapy|
757193|NCT00010803|B3|Baseline|Total|Total of all reporting groups
757194|NCT00010803|B2|Baseline|Placebo|Placebo 1 pill twice daily
757195|NCT00010803|B1|Baseline|Ginkgo Biloba|120 mg twice daily, total 240 mg
757196|NCT00010803|P2|Participant Flow|Placebo|Placebo twice daily
757197|NCT00010803|P1|Participant Flow|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
757198|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
757199|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
757200|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
757201|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
757202|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
757206|NCT00010439|B1|Baseline|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
757207|NCT00010439|P1|Participant Flow|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
757208|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
757209|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
757210|NCT00010439|E1|Reported Event|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
757211|NCT00007644|B3|Baseline|Total|Total of all reporting groups
757212|NCT00007644|B2|Baseline|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
757213|NCT00007644|B1|Baseline|Radical Prostatectomy|Surgical removal of the prostate
757214|NCT00007644|P2|Participant Flow|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
757215|NCT00007644|P1|Participant Flow|Radical Prostatectomy|Surgical removal of the prostate
757216|NCT00007644|O2|Outcome|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
757217|NCT00007644|O1|Outcome|Radical Prostatectomy|Surgical removal of the prostate
757218|NCT00007644|E2|Reported Event|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
757219|NCT00007644|E1|Reported Event|Radical Prostatectomy|Surgical removal of the prostate
757220|NCT00007475|B4|Baseline|Total|Total of all reporting groups
757221|NCT00007475|B3|Baseline|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of validated FPF assay
757222|NCT00007475|B2|Baseline|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757223|NCT00007475|B1|Baseline|FPF NOT Assayed Provisionally, PE + Cyclophosphamide Completed|Participants not provisionally assayed for FPF, yet still complete both series of protocol treatment: Plasma Exchange (PE) and Cyclophosphamide; note that these form a majority of enrollees due to limited availability of validated FPF assay (such an assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial; see Outcome Measures for more details)
757224|NCT00007475|P4|Participant Flow|Historical Controls|Noted as Group F in study protocol: historical control patients, including patients at NIH or other institutions who have previously undergone renal transplant, for whom stored sera are available, and for whom consent to measure FPF has been can be obtained. In some cases, these measurements have been performed by Dr. Savin under pre-existing protocols and these data are already available.
757225|NCT00007475|P3|Participant Flow|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757226|NCT00007475|P2|Participant Flow|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757227|NCT00007475|P1|Participant Flow|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants not assayed for FSGS Permeability Factor (FPF) levels pre-treatment (Tx), yet still complete both series of protocol-specified treatment; FPF levels NOT available as its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial
757228|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
757229|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757230|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
757231|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
757232|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757233|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
757234|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
757235|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757236|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
757237|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
757238|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757272|NCT00006489|P4|Participant Flow|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
757239|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment: Plasma Exchange + Cyclophosphamide
757240|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
757241|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757242|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment, Plasma Exchange and Cyclophosphamide.
757243|NCT00007475|E3|Reported Event|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Original protocol Group D (FPF 0.6 or greater pre-initial Transplant)
757244|NCT00007475|E2|Reported Event|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Original protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
757245|NCT00007475|E1|Reported Event|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants for whom the Focal Segmental Glomerulosclerosis (FSGS) Permeability Factor, or FPF was not able to be assayed, yet enrolled and completed both protocol-specified interventions: the plasma exchange procedure and treatment by cyclophosphamide.
757246|NCT00007345|B3|Baseline|Total|Total of all reporting groups
757247|NCT00007345|B2|Baseline|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757248|NCT00007345|B1|Baseline|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757249|NCT00007345|P2|Participant Flow|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757250|NCT00007345|P1|Participant Flow|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757251|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757252|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757253|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757254|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757255|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757256|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757257|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757258|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757259|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757260|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757261|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757262|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757263|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757264|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757265|NCT00007345|E2|Reported Event|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757266|NCT00007345|E1|Reported Event|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
757267|NCT00006489|B5|Baseline|Total|Total of all reporting groups
757268|NCT00006489|B4|Baseline|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
757269|NCT00006489|B3|Baseline|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
757270|NCT00006489|B2|Baseline|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
757273|NCT00006489|P3|Participant Flow|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
757274|NCT00006489|P2|Participant Flow|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
757275|NCT00006489|P1|Participant Flow|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
757276|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
757277|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
757278|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
757279|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
757280|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
757281|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
757282|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
757283|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
757284|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
757285|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
757286|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
757287|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
757288|NCT00006489|E4|Reported Event|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
757289|NCT00006489|E3|Reported Event|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
757290|NCT00006489|E2|Reported Event|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
757291|NCT00006489|E1|Reported Event|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
757292|NCT00006409|B7|Baseline|Total|Total of all reporting groups
757293|NCT00006409|B6|Baseline|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757294|NCT00006409|B5|Baseline|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757295|NCT00006409|B4|Baseline|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757296|NCT00006409|B3|Baseline|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757297|NCT00006409|B2|Baseline|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
757298|NCT00006409|B1|Baseline|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
757299|NCT00006409|P6|Participant Flow|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757300|NCT00006409|P5|Participant Flow|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757301|NCT00006409|P4|Participant Flow|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757302|NCT00006409|P3|Participant Flow|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757303|NCT00006409|P2|Participant Flow|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
757304|NCT00006409|P1|Participant Flow|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
757305|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757423|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757306|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757307|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757308|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757309|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
757310|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
757311|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757312|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757313|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757314|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757315|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
757316|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
757317|NCT00006409|E6|Reported Event|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757318|NCT00006409|E5|Reported Event|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
757319|NCT00006409|E4|Reported Event|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757320|NCT00006409|E3|Reported Event|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
757321|NCT00006409|E2|Reported Event|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
757322|NCT00006409|E1|Reported Event|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
757323|NCT00006305|B5|Baseline|Total|Total of all reporting groups
757324|NCT00006305|B4|Baseline|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
757325|NCT00006305|B3|Baseline|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
757326|NCT00006305|B2|Baseline|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
757327|NCT00006305|B1|Baseline|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
757328|NCT00006305|P4|Participant Flow|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
757329|NCT00006305|P3|Participant Flow|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
757330|NCT00006305|P2|Participant Flow|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
757331|NCT00006305|P1|Participant Flow|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
757332|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
757333|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
757334|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
757335|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
757336|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
757337|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
757338|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
757339|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
757340|NCT00006305|E4|Reported Event|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
757341|NCT00006305|E3|Reported Event|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
757342|NCT00006305|E2|Reported Event|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
757343|NCT00006305|E1|Reported Event|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
757344|NCT00006289|B3|Baseline|Total|Total of all reporting groups
757345|NCT00006289|B2|Baseline|Neurotropin First, Then Placebo|Receive Neurotropin 4 tabs b.i.d. for 5 weeks and then Placebo 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
757346|NCT00006289|B1|Baseline|Placebo First, Then Neurotropin|Receive Placebo 4 tabs b.i.d. for 5 weeks and then Neurotropin 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
757347|NCT00006289|P2|Participant Flow|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
757348|NCT00006289|P1|Participant Flow|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
757349|NCT00006289|O4|Outcome|MPQ After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. MPQ was determined at the end of the 5 week-treatment of placebo."
757350|NCT00006289|O3|Outcome|MPQ After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
757351|NCT00006289|O2|Outcome|MPQ After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. MPQ was determined at the end of the 5 week-treatment of Neurotropin."
757352|NCT00006289|O1|Outcome|MPQ After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
757353|NCT00006289|O4|Outcome|NRS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. NRS was determined at the end of the 5 week-treatment of placebo."
757354|NCT00006289|O3|Outcome|NRS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
757355|NCT00006289|O2|Outcome|NRS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. NRS was determined at the end of the 5 week-treatment of Neurotropin."
757356|NCT00006289|O1|Outcome|NRS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
757357|NCT00006289|O4|Outcome|VAS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo."
757358|NCT00006289|O3|Outcome|VAS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
757359|NCT00006289|O2|Outcome|VAS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin."
757360|NCT00006289|O1|Outcome|VAS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
757361|NCT00006289|E2|Reported Event|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
757362|NCT00006289|E1|Reported Event|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
757363|NCT00006184|B3|Baseline|Total|Total of all reporting groups
757364|NCT00006184|B2|Baseline|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
757365|NCT00006184|B1|Baseline|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
757366|NCT00006184|P2|Participant Flow|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
757367|NCT00006184|P1|Participant Flow|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
757368|NCT00006184|O2|Outcome|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
757369|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
757370|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
757371|NCT00006184|E2|Reported Event|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
757372|NCT00006184|E1|Reported Event|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
757373|NCT00006178|B1|Baseline|Sirolimus Monotherapy|
757374|NCT00006178|P1|Participant Flow|Sirolimus Monotherapy|
757375|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
757376|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
757377|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
757378|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
757379|NCT00006178|E1|Reported Event|Sirolimus Monotherapy|
757380|NCT00006170|B5|Baseline|Total|Total of all reporting groups
757381|NCT00006170|B4|Baseline|SS+P|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
757382|NCT00006170|B3|Baseline|SS+B|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
757383|NCT00006170|B2|Baseline|WC+P|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion.
757384|NCT00006170|B1|Baseline|WC+B|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
757385|NCT00006170|P4|Participant Flow|Social Support + Placebo (SS+P)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
757386|NCT00006170|P3|Participant Flow|Social Support + Bupropion (SS+B)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
757387|NCT00006170|P2|Participant Flow|Weight Concerns + Placebo (WC+P)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion.
757388|NCT00006170|P1|Participant Flow|Weight Concerns + Bupropion (WC+B)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
757389|NCT00006170|O4|Outcome|SS+P|
757390|NCT00006170|O3|Outcome|SS+B|
757391|NCT00006170|O2|Outcome|WC+P|
757392|NCT00006170|O1|Outcome|WC+B|
757393|NCT00006170|O4|Outcome|SS+P|
757394|NCT00006170|O3|Outcome|SS+B|
757395|NCT00006170|O2|Outcome|WC+P|
757396|NCT00006170|O1|Outcome|WC+B|
757397|NCT00006170|O4|Outcome|SS+P|
757398|NCT00006170|O3|Outcome|SS+B|
757399|NCT00006170|O2|Outcome|WC+P|
757400|NCT00006170|O1|Outcome|WC+B|
757401|NCT00006170|E4|Reported Event|SS+P|
757402|NCT00006170|E3|Reported Event|SS+B|
757403|NCT00006170|E2|Reported Event|WC+P|
757404|NCT00006170|E1|Reported Event|WC+B|
757405|NCT00006156|B3|Baseline|Total|Total of all reporting groups
757406|NCT00006156|B2|Baseline|Control|
757407|NCT00006156|B1|Baseline|Drug - FSH|
757408|NCT00006156|P2|Participant Flow|Control|
757409|NCT00006156|P1|Participant Flow|Drug - FSH|
757410|NCT00006156|O2|Outcome|Control|
757411|NCT00006156|O1|Outcome|Drug - FSH|
757412|NCT00006156|O2|Outcome|Control|
757413|NCT00006156|O1|Outcome|Drug - FSH|
757414|NCT00006156|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
757415|NCT00006164|B3|Baseline|Total|Total of all reporting groups
757416|NCT00006164|B2|Baseline|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757417|NCT00006164|B1|Baseline|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757418|NCT00006164|P2|Participant Flow|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757419|NCT00006164|P1|Participant Flow|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757420|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757421|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757422|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757424|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757425|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757426|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757427|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757428|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757429|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757430|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757431|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757432|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757433|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757434|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757435|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757436|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757437|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757438|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757439|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757440|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757441|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757442|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757443|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757444|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757445|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757446|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757447|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757448|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757449|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757450|NCT00006164|E2|Reported Event|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
757451|NCT00006164|E1|Reported Event|Peginterferon Alfa-2a 90 mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
757452|NCT00006151|B3|Baseline|Total|Total of all reporting groups
757453|NCT00006151|B2|Baseline|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
757454|NCT00006151|B1|Baseline|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
757455|NCT00006151|P2|Participant Flow|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
757456|NCT00006151|P1|Participant Flow|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
757457|NCT00006151|O2|Outcome|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
757458|NCT00006151|O1|Outcome|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
757459|NCT00006151|E2|Reported Event|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
757460|NCT00006151|E1|Reported Event|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
757461|NCT00005937|B1|Baseline|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Antithymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration, the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
757494|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
757495|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
757496|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
757462|NCT00005937|P1|Participant Flow|MDS Subjects Treated With ATG & CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
757463|NCT00005937|O1|Outcome|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
757464|NCT00005937|E1|Reported Event|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
757465|NCT00005908|B1|Baseline|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
757466|NCT00005908|P2|Participant Flow|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
757467|NCT00005908|P1|Participant Flow|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
757468|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
757469|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15
757470|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
757471|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
757472|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
757473|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
757474|NCT00005908|E1|Reported Event|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
757475|NCT00005906|B1|Baseline|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
757476|NCT00005906|P1|Participant Flow|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
757477|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
757478|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
757479|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
757480|NCT00005906|E1|Reported Event|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
757481|NCT00005901|B3|Baseline|Total|Total of all reporting groups
757482|NCT00005901|B2|Baseline|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
757483|NCT00005901|B1|Baseline|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
757484|NCT00005901|P2|Participant Flow|Active Comparator: 2|Receives treatment every 6 months.
757485|NCT00005901|P1|Participant Flow|Active Comparator: 1|Receives treatment every 3 months
757486|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
757487|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
757488|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
757489|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
757490|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
757491|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
757492|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
757493|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
757497|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
757498|NCT00005901|E2|Reported Event|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
757499|NCT00005901|E1|Reported Event|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
757500|NCT00005669|B3|Baseline|Total|Total of all reporting groups
757501|NCT00005669|B2|Baseline|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757502|NCT00005669|B1|Baseline|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757503|NCT00005669|P2|Participant Flow|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757504|NCT00005669|P1|Participant Flow|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757505|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757506|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757507|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757508|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757509|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757510|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757511|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757512|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757513|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757514|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757515|NCT00005669|E2|Reported Event|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757516|NCT00005669|E1|Reported Event|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
757517|NCT00004980|B3|Baseline|Total|Total of all reporting groups
757518|NCT00004980|B2|Baseline|Placebo|Participants received sham stimulation
757519|NCT00004980|B1|Baseline|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
757520|NCT00004980|P2|Participant Flow|Placebo|Participants received sham stimulation
757521|NCT00004980|P1|Participant Flow|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
757522|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
757523|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
757524|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
757525|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
757526|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
757527|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
757528|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
757529|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
757530|NCT00004980|E2|Reported Event|Placebo|Participants received sham stimulation
757531|NCT00004980|E1|Reported Event|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
757532|NCT00004732|B3|Baseline|Total|Total of all reporting groups
757533|NCT00004732|B2|Baseline|Carotid Endarterectomy|Patients Randomized to CEA
757534|NCT00004732|B1|Baseline|Carotid-Artery Stenting|Patients Randomized to CAS
757535|NCT00004732|P2|Participant Flow|Carotid Endarterectomy (CEA)|CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
757567|NCT00004563|E2|Reported Event|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
757536|NCT00004732|P1|Participant Flow|Carotid-Artery Stenting (CAS)|CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.
757537|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients randomized to CEA
757538|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients randomized to CAS
757539|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients Randomized to CEA
757540|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients Randomized to CAS
757541|NCT00004732|E2|Reported Event|Carotid Endarterectomy|Patients Randomized to CEA
757542|NCT00004732|E1|Reported Event|Carotid-Artery Stenting|Patients Randomized to CAS
757543|NCT00004635|B3|Baseline|Total|Total of all reporting groups
757544|NCT00004635|B2|Baseline|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
757545|NCT00004635|B1|Baseline|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
757546|NCT00004635|P2|Participant Flow|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
757547|NCT00004635|P1|Participant Flow|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
757548|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2.
757549|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
757550|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2
757551|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
757552|NCT00004635|E4|Reported Event|Leuprolide|
757553|NCT00004635|E3|Reported Event|Goserelin (Zoladex)|
757554|NCT00004635|E2|Reported Event|Placebo|
757555|NCT00004635|E1|Reported Event|Thalidomide|
757556|NCT00004563|B3|Baseline|Total|Total of all reporting groups
757557|NCT00004563|B2|Baseline|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
757558|NCT00004563|B1|Baseline|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
757559|NCT00004563|P2|Participant Flow|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
757560|NCT00004563|P1|Participant Flow|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
757561|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
757562|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
757563|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
757564|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
757565|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
757566|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
757634|NCT00000392|B3|Baseline|Total|Total of all reporting groups
757568|NCT00004563|E1|Reported Event|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
757569|NCT00004562|B3|Baseline|Total|Total of all reporting groups
757570|NCT00004562|B2|Baseline|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
757571|NCT00004562|B1|Baseline|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
757572|NCT00004562|P2|Participant Flow|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
757573|NCT00004562|P1|Participant Flow|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
757574|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
757575|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
757576|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
757577|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
757578|NCT00004562|E2|Reported Event|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
757579|NCT00004562|E1|Reported Event|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
757580|NCT00004547|B4|Baseline|Total|Total of all reporting groups
757581|NCT00004547|B3|Baseline|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
757582|NCT00004547|B2|Baseline|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
757583|NCT00004547|B1|Baseline|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
757584|NCT00004547|P3|Participant Flow|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
757585|NCT00004547|P2|Participant Flow|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
757586|NCT00004547|P1|Participant Flow|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
757587|NCT00004547|O2|Outcome|Tumor Tissue|Diseased tissue
757588|NCT00004547|O1|Outcome|Normal Tissue|Non-diseased tissue
757589|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
757590|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
757591|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
757592|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
757593|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
757594|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
757595|NCT00004547|O1|Outcome|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
757596|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
757597|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
757598|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
757599|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
757600|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
757601|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
757602|NCT00004547|E1|Reported Event|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
757603|NCT00001984|B1|Baseline|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757604|NCT00001984|P1|Participant Flow|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757605|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757606|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757607|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757608|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757609|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757610|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757611|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757635|NCT00000392|B2|Baseline|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
757612|NCT00001984|E1|Reported Event|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
757613|NCT00001962|B1|Baseline|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
757614|NCT00001962|P1|Participant Flow|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.The Diamond Blackfan anemia arm was closed due to lack of accrual.
757615|NCT00001962|O1|Outcome|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment.
757616|NCT00001962|E1|Reported Event|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
757617|NCT00001959|B1|Baseline|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
757618|NCT00001959|P1|Participant Flow|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
757619|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
757620|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
757621|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
757622|NCT00001959|E1|Reported Event|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
757623|NCT00001941|B1|Baseline|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757624|NCT00001941|P5|Participant Flow|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757625|NCT00001941|P4|Participant Flow|Phase I - 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757626|NCT00001941|P3|Participant Flow|Phase I - 6 mg/kg Cohort|6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757627|NCT00001941|P2|Participant Flow|Phase I - 4 mg/kg Cohort|4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757628|NCT00001941|P1|Participant Flow|Phase I - 2 mg/kg Cohort|2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2
757629|NCT00001941|O1|Outcome|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757630|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757631|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757632|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757633|NCT00001941|E1|Reported Event|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
757636|NCT00000392|B1|Baseline|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
757637|NCT00000392|P2|Participant Flow|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
757638|NCT00000392|P1|Participant Flow|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
757639|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
757640|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
757641|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
757642|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
757643|NCT00000392|E2|Reported Event|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
757644|NCT00000392|E1|Reported Event|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
757645|NCT00001832|B15|Baseline|Total|Total of all reporting groups
757646|NCT00001832|B14|Baseline|Cells IV + SQ IL-2 w/GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF in patients with no reactivity
757647|NCT00001832|B13|Baseline|Cells IV + SQ IL-2 w/GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757648|NCT00001832|B12|Baseline|Cells IV + SQ IL-2 w/GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF (to shorten time to neutrophil recovery), reactivity not specified
757649|NCT00001832|B11|Baseline|Cells IV + MTD IL-2 no GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757650|NCT00001832|B10|Baseline|Cells IV + MTD IL-2 no GCSF (gp100 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
757651|NCT00001832|B9|Baseline|Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
757652|NCT00001832|B8|Baseline|Cells IA + MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757653|NCT00001832|B7|Baseline|Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF
757654|NCT00001832|B6|Baseline|Cells IA + MTD IL-2 (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + G-CSF
757655|NCT00001832|B5|Baseline|Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF (to shorten time to neutrophil recovery)
757656|NCT00001832|B4|Baseline|Cells IV + High-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
757657|NCT00001832|B3|Baseline|Cells IV + Low-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
757658|NCT00001832|B2|Baseline|Cells IV + Cyclophosphamide 60mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV
757659|NCT00001832|B1|Baseline|Cells IV + Cyclophosphamide 30mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x30mg/kg + Cells IV
757660|NCT00001832|P15|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
757661|NCT00001832|P14|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757662|NCT00001832|P13|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
757663|NCT00001832|P12|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757664|NCT00001832|P11|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
757687|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
757665|NCT00001832|P10|Participant Flow|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
757666|NCT00001832|P9|Participant Flow|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757667|NCT00001832|P8|Participant Flow|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
757668|NCT00001832|P7|Participant Flow|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
757669|NCT00001832|P6|Participant Flow|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
757670|NCT00001832|P5|Participant Flow|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
757671|NCT00001832|P4|Participant Flow|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
757672|NCT00001832|P3|Participant Flow|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
757673|NCT00001832|P2|Participant Flow|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
757674|NCT00001832|P1|Participant Flow|Abl Cells in Culture|Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
757675|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
757676|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757677|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
757678|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757679|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
757680|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
757681|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757682|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
757683|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
757684|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
757685|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
757686|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
757688|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
757689|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
757690|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757691|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
757692|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757693|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
757694|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
757695|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757696|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
757697|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
757698|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
757699|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
757700|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
757701|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
757702|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
757703|NCT00001832|E14|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
757704|NCT00001832|E13|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757705|NCT00001832|E12|Reported Event|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
757706|NCT00001832|E11|Reported Event|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757707|NCT00001832|E10|Reported Event|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
757736|NCT00001703|B1|Baseline|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
757708|NCT00001832|E9|Reported Event|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
757709|NCT00001832|E8|Reported Event|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
757710|NCT00001832|E7|Reported Event|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
757711|NCT00001832|E6|Reported Event|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
757712|NCT00001832|E5|Reported Event|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
757713|NCT00001832|E4|Reported Event|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
757714|NCT00001832|E3|Reported Event|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
757715|NCT00001832|E2|Reported Event|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
757716|NCT00001832|E1|Reported Event|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
757717|NCT00001723|B3|Baseline|Total|Total of all reporting groups
757718|NCT00001723|B2|Baseline|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757719|NCT00001723|B1|Baseline|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757720|NCT00001723|P2|Participant Flow|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757721|NCT00001723|P1|Participant Flow|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757722|NCT00001723|O4|Outcome|Placebo - Non-Hispanic Whites|Change in weight for Non-Hispanic White participants treated with placebo
757723|NCT00001723|O3|Outcome|Placebo - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with placebo
757724|NCT00001723|O2|Outcome|Orlistat - Non- Hispanic Whites|Change in weight for Non-Hispanic White participants treated with orlistat
757725|NCT00001723|O1|Outcome|Orlistat - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with orlistat
757726|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757727|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757728|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757729|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757730|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757731|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757732|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757733|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
757734|NCT00001723|E2|Reported Event|Placebo|Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
757735|NCT00001723|E1|Reported Event|Orlistat|Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
757794|NCT00001596|E1|Reported Event|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757795|NCT00001586|B3|Baseline|Total|Total of all reporting groups
757737|NCT00001703|P1|Participant Flow|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
757738|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
757739|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
757740|NCT00001703|E1|Reported Event|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
757741|NCT00001656|B3|Baseline|Total|Total of all reporting groups
757742|NCT00001656|B2|Baseline|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757743|NCT00001656|B1|Baseline|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757744|NCT00001656|P2|Participant Flow|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757745|NCT00001656|P1|Participant Flow|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757746|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757747|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757748|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757749|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757750|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757751|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757796|NCT00001586|B2|Baseline|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
757861|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757752|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757753|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757754|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757755|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757756|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757757|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757758|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757759|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757760|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757761|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757762|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757763|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757797|NCT00001586|B1|Baseline|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
757764|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757765|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757766|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757767|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757768|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757769|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757770|NCT00001656|E2|Reported Event|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757771|NCT00001656|E1|Reported Event|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
757772|NCT00001596|B3|Baseline|Total|Total of all reporting groups
757773|NCT00001596|B2|Baseline|Placebo|Subjects received placebo (3 pills), three times daily.
757774|NCT00001596|B1|Baseline|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757775|NCT00001596|P2|Participant Flow|Placebo|Subjects received placebo (3 pills), three times daily.
757776|NCT00001596|P1|Participant Flow|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757777|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757778|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757779|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757780|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757781|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757782|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757783|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757784|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757785|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757786|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757787|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757788|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757789|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757790|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757791|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
757792|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
757793|NCT00001596|E2|Reported Event|Placebo|Subjects received placebo (3 pills), three times daily.
757798|NCT00001586|P2|Participant Flow|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells.
757799|NCT00001586|P1|Participant Flow|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
757800|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
757801|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
757802|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
757803|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
757804|NCT00001586|E2|Reported Event|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
757805|NCT00001586|E1|Reported Event|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
757806|NCT00001575|B1|Baseline|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
757807|NCT00001575|P1|Participant Flow|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
757808|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
757809|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
757810|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
757811|NCT00001575|E1|Reported Event|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
757812|NCT00001566|B1|Baseline|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757813|NCT00001566|P1|Participant Flow|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757814|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757815|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757816|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757817|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757818|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757819|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757820|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757821|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757822|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757823|NCT00001566|E1|Reported Event|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
757824|NCT00001304|B3|Baseline|Total|Total of all reporting groups
757825|NCT00001304|B2|Baseline|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757826|NCT00001304|B1|Baseline|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757827|NCT00001304|P2|Participant Flow|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757828|NCT00001304|P1|Participant Flow|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757829|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757830|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757831|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757832|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757833|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757834|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757835|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757836|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757837|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757838|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757839|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757840|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757841|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
757842|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
757843|NCT00001304|E2|Reported Event|Calcitriol & Calcium|"All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.~Calcitriol & Calcium"
757844|NCT00001304|E1|Reported Event|PTH 1-34|"All patients received twice daily synthetic Human Parathyroid Hormone 1-34.~PTH 1-34"
757845|NCT00001262|B4|Baseline|Total|Total of all reporting groups
757846|NCT00001262|B3|Baseline|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757847|NCT00001262|B2|Baseline|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757848|NCT00001262|B1|Baseline|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757849|NCT00001262|P3|Participant Flow|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757850|NCT00001262|P2|Participant Flow|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757851|NCT00001262|P1|Participant Flow|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757852|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757853|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757854|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757855|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757856|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757857|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757858|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757859|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757860|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757862|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757863|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757864|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757865|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757866|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757867|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757868|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757869|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757870|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757871|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757872|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757873|NCT00001262|E3|Reported Event|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
757874|NCT00001262|E2|Reported Event|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
757875|NCT00001262|E1|Reported Event|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
757876|NCT00001213|B1|Baseline|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
757877|NCT00001213|P1|Participant Flow|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
757878|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
757879|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
757880|NCT00001213|E1|Reported Event|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
757881|NCT00001151|B1|Baseline|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
757882|NCT00001151|P1|Participant Flow|Group 1|Patient has rickets (child) or osteomalacia (adult) of bone
757883|NCT00001151|O1|Outcome|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
757884|NCT00001151|E1|Reported Event|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
757885|NCT00000378|B3|Baseline|Total|Total of all reporting groups
757886|NCT00000378|B2|Baseline|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
757887|NCT00000378|B1|Baseline|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
757888|NCT00000378|P2|Participant Flow|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
757889|NCT00000378|P1|Participant Flow|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
757890|NCT00000378|O2|Outcome|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
757891|NCT00000378|O1|Outcome|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
757892|NCT00000378|E2|Reported Event|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
757893|NCT00000378|E1|Reported Event|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
757894|NCT00000371|B3|Baseline|Total|Total of all reporting groups
757895|NCT00000371|B2|Baseline|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
757896|NCT00000371|B1|Baseline|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
757897|NCT00000371|P2|Participant Flow|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
757898|NCT00000371|P1|Participant Flow|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
757899|NCT00000371|O2|Outcome|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
757900|NCT00000371|O1|Outcome|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
757901|NCT00000371|E2|Reported Event|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
757902|NCT00000371|E1|Reported Event|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
757903|NCT00000620|B3|Baseline|Total|Total of all reporting groups
757904|NCT00000620|B2|Baseline|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757905|NCT00000620|B1|Baseline|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757906|NCT00000620|P8|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
757907|NCT00000620|P7|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
757908|NCT00000620|P6|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg)."
757909|NCT00000620|P5|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
757910|NCT00000620|P4|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
757911|NCT00000620|P3|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
757912|NCT00000620|P2|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
757913|NCT00000620|P1|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
757914|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
757915|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
757916|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
757917|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
757918|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level to <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
757919|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
757920|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
757921|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
757922|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757923|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757924|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757925|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757926|NCT00000620|E2|Reported Event|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757927|NCT00000620|E1|Reported Event|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
757928|NCT00000575|B4|Baseline|Total|Total of all reporting groups
757929|NCT00000575|B3|Baseline|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757930|NCT00000575|B2|Baseline|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757931|NCT00000575|B1|Baseline|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757932|NCT00000575|P3|Participant Flow|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757933|NCT00000575|P2|Participant Flow|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757934|NCT00000575|P1|Participant Flow|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757935|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757936|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757937|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757938|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757939|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757940|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757941|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757942|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757943|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757944|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757945|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757946|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757947|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757948|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757949|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757950|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757951|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757952|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757953|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757954|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757955|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757956|NCT00000575|E3|Reported Event|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
757957|NCT00000575|E2|Reported Event|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
757958|NCT00000575|E1|Reported Event|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
757959|NCT00000479|B5|Baseline|Total|Total of all reporting groups
757960|NCT00000479|B4|Baseline|Both Placebos|Placebo aspirin and placebo vitamin E
757961|NCT00000479|B3|Baseline|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
757962|NCT00000479|B2|Baseline|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
757963|NCT00000479|B1|Baseline|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
757964|NCT00000479|P4|Participant Flow|Both Placebos|Placebo aspirin and placebo vitamin E
757965|NCT00000479|P3|Participant Flow|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
757966|NCT00000479|P2|Participant Flow|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
757967|NCT00000479|P1|Participant Flow|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
757968|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
757969|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
757970|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
757971|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
757972|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
757973|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
757974|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
757975|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
757976|NCT00000479|E4|Reported Event|Both Placebos|Placebo aspirin and placebo vitamin E
757977|NCT00000479|E3|Reported Event|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
757978|NCT00000479|E2|Reported Event|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
757979|NCT00000479|E1|Reported Event|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
757980|NCT00004500|B3|Baseline|Total|Total of all reporting groups
757981|NCT00004500|B2|Baseline|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
757982|NCT00004500|B1|Baseline|Lucinactant|Lucinactant via bronchoaveolar lavage
757983|NCT00004500|P2|Participant Flow|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
757984|NCT00004500|P1|Participant Flow|Lucinactant|Lucinactant via bronchoaveolar lavage
757985|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
757986|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
757987|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
757988|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
757989|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
757990|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
757991|NCT00004500|E2|Reported Event|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
757992|NCT00004500|E1|Reported Event|Lucinactant|Lucinactant via bronchoaveolar lavage
757993|NCT00004412|B4|Baseline|Total|Total of all reporting groups
757994|NCT00004412|B3|Baseline|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Standard local care dressing only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
757995|NCT00004412|B2|Baseline|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
757996|NCT00004412|B1|Baseline|Standard Local Care Dressing|Standard local care dressing including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
757997|NCT00004412|P3|Participant Flow|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Allevyn Hydrophilic PU dressing (standard local care) only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
757998|NCT00004412|P2|Participant Flow|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
757999|NCT00004412|P1|Participant Flow|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
758000|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
758001|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
758002|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
758003|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
758004|NCT00004412|E2|Reported Event|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
758005|NCT00004412|E1|Reported Event|Standard Local Care Dressing|Standard local care including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
758006|NCT00000143|B3|Baseline|Total|Total of all reporting groups
758007|NCT00000143|B2|Baseline|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
758008|NCT00000143|B1|Baseline|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
758009|NCT00000143|P2|Participant Flow|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
758010|NCT00000143|P1|Participant Flow|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
758011|NCT00000143|O2|Outcome|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
758012|NCT00000143|O1|Outcome|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
758013|NCT00000143|E2|Reported Event|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
758014|NCT00000143|E1|Reported Event|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
758015|NCT00000142|B4|Baseline|Total|Total of all reporting groups
758016|NCT00000142|B3|Baseline|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758017|NCT00000142|B2|Baseline|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758018|NCT00000142|B1|Baseline|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758019|NCT00000142|P3|Participant Flow|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758038|NCT00000135|B2|Baseline|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758020|NCT00000142|P2|Participant Flow|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758021|NCT00000142|P1|Participant Flow|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758022|NCT00000142|O3|Outcome|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758023|NCT00000142|O2|Outcome|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758024|NCT00000142|O1|Outcome|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758025|NCT00000142|E3|Reported Event|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758026|NCT00000142|E2|Reported Event|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758027|NCT00000142|E1|Reported Event|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
758028|NCT00000136|B3|Baseline|Total|Total of all reporting groups
758029|NCT00000136|B2|Baseline|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758030|NCT00000136|B1|Baseline|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758031|NCT00000136|P2|Participant Flow|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758032|NCT00000136|P1|Participant Flow|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758033|NCT00000136|O2|Outcome|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758034|NCT00000136|O1|Outcome|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758035|NCT00000136|E2|Reported Event|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758036|NCT00000136|E1|Reported Event|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
758037|NCT00000135|B3|Baseline|Total|Total of all reporting groups
758039|NCT00000135|B1|Baseline|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758040|NCT00000135|P2|Participant Flow|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758041|NCT00000135|P1|Participant Flow|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758042|NCT00000135|O2|Outcome|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758043|NCT00000135|O1|Outcome|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758044|NCT00000135|E2|Reported Event|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758045|NCT00000135|E1|Reported Event|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
758046|NCT00000134|B4|Baseline|Total|Total of all reporting groups
758047|NCT00000134|B3|Baseline|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758048|NCT00000134|B2|Baseline|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
758049|NCT00000134|B1|Baseline|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758050|NCT00000134|P3|Participant Flow|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758051|NCT00000134|P2|Participant Flow|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
758052|NCT00000134|P1|Participant Flow|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758053|NCT00000134|O3|Outcome|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758054|NCT00000134|O2|Outcome|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
758055|NCT00000134|O1|Outcome|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758056|NCT00000134|E3|Reported Event|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758057|NCT00000134|E2|Reported Event|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
758058|NCT00000134|E1|Reported Event|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
758059|NCT00000125|B3|Baseline|Total|Total of all reporting groups
758060|NCT00000125|B2|Baseline|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents
758061|NCT00000125|B1|Baseline|Observation|Observation only
758062|NCT00000125|P2|Participant Flow|Treatment|Topical ocular hypotensive eye drops.
758063|NCT00000125|P1|Participant Flow|Observation|Close Observation
758064|NCT00000125|O2|Outcome|Treatment|Topical ocular hypotensive eye drops from February 1994 through March 2009.
758065|NCT00000125|O1|Outcome|Observation|Observation only from February 1994 through June 2002.Observation participants were offered topical antiglaucoma agents after June 2002 through study close out March 2009.
758066|NCT00000125|E2|Reported Event|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.
758067|NCT00000125|E1|Reported Event|Observation|Observation only from February 1994 to June 2002 .
